Regular Delivery Service, let us remember for you!

Kesium Chewable Tablets for Dogs & Cats

Kesium Chewable Tablets for Dogs & Cats

  • 50mg » Priced per tablet £0.40
  • 62.5mg » Priced per tablet £0.49
  • 250mg » Priced per Tablet £0.89
  • 500mg » Priced per Tablet £1.79
  • 625mg » Priced per Tablet £2.80

Selection of 5 products from

£0.40 to £2.80

Description

Kesium is a broad spectrum antibiotic which is active against a wide range of bacterial infections in dogs and cats. It can be used for infections of the mouth, gastro-intestinal tract, respiratory system, urinary system or skin. Kesium is also effective in treating infected wounds. Normally Kesium is dosed twice daily for as long as is required to clear the infection.

Need help or advice? Contact us:

  • Landline: 01582 842096
  • Mon - Fri: 8:30am - 5:00pm
  • Sat: 9:00am - 1:00pm (Collections only)
  • Email: [email protected]

All prices include VAT where applicable.

Medication Datasheets

250mg » Priced per Tablet

Kesium 50 mg & 62.5 mg chewable tablets for cats & dogs and Kesium 250 mg, 500 mg & 625 mg chewable tablets for dogs

Kesium 50 mg & 62.5 mg chewable tablets for cats & dogs and Kesium 250 mg, 500 mg & 625 mg chewable tablets for dogs

Qualitative and quantitative composition

Each Kesium 50 mg tablet contains: Amoxicillin (as amoxicillin trihydrate) 40.00 mg and clavulanic acid (as potassium clavulanate) 10.00 mg

Each Kesium 62.5mg tablet contains: Amoxicillin (as amoxicillin trihydrate) 50.00 mg and clavulanic acid (as potassium clavulanate) 12.5 mg

Each Kesium 250 mg tablet contains: Amoxicillin (as amoxicillin trihydrate) 200.00 mg and clavulanic acid (as potassium clavulanate) 50.00 mg

Each Kesium 500 mg tablet contains: Amoxicillin (as amoxicillin trihydrate) 400.00 mg and clavulanic acid (as potassium clavulanate) 100 mg

Each Kesium 625 mg tablet contains: Amoxicillin (as amoxicillin trihydrate) 500.00 mg and clavulanic acid (as potassium clavulanate) 125 mg

Pharmaceutical form

Kesium 50 mg, 62.5 mg and 500 mg tablets are oblong, scored, chewable tablets that can be divided into equal halves.

Kesium 250 mg and 625 mg tablets are clover-shaped, beige, chewable tablets that can be divided into four equal parts.

Clinical particulars

Target species

Dogs and cats.

Indications for use

For the treatment of the following infections caused by β lactamase producing strains of bacteria sensitive to amoxicillin in combination with clavulanic acid and where clinical experience and/or sensitivity testing indicates the product as the drug of choice:

-Skin infections (including superficial and deep pyodermas) associated with Staphylococcus spp.

-Urinary tract infections associated with Staphylococcus spp, Streptococcus spp, Escherichia coli and Proteus mirabilis.

-Respiratory tract infections associated with Staphylococcus spp, Streptococcus spp and Pasteurella spp.

-Digestive tract infections associated with Escherichia coli.

-Infections of the oral cavity (mucous membrane) associated with Pasteurella spp, Streptococcus spp, Escherichia coli.

Contraindications

Do not use in animals with known hypersensitivity to penicillins or other susbstances of the β-lactam group or to any excipients.

Do not use in animals with serious dysfunction of the kidneys accompanied by anuria and oliguria.

Do not administer to gerbils, guinea pigs, hamsters, rabbits and chinchillas. Do not use in horses and ruminating animals.

Do not use where resistance to this combination is known to occur.

Special precautions for use in animals

Official, national and regional antimicrobial policies with respect to the use of broad-spectrum antibiotics should be taken into account. Do not use in case of bacteria sensitive to narrow spectrum penicillins or to amoxicillin as single substance. It is advised that upon initiating therapy appropriate sensitivity testing is performed and that therapy is continued only after susceptibility to the combination has been established. Use of the product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to the amoxicillin/clavulanate, and may decrease the effectiveness of treatment with beta-lactam antibiotics.

In animals with hepatic and renal dysfunction, the dosing regimen should be carefully evaluated and the use of the product based on a risk/benefit evaluation by the veterinary surgeon.

Caution is advised in the use in small herbivores other than those indicated in 'Contraindications'.

The potential for allergic cross-reactions with other penicillin derivates and cephalosporins should be considered.

Special precautions to be taken by the person administering the veterinary medicinal product to animals

Penicillins and cephalosporins may cause hypersensitivity (allergy) following injection, inhalation, ingestion or skin contact. Hypersensitivity to penicillins may lead to cross-reactions to cephalosporins and vice versa. Allergic reactions to these substances may occasionally be serious. Do not handle this product if you know you are sensitised, or if you have been advised not to work with such preparations. Handle this product with great care to avoid exposure, taking all recommended precautions. If you develop symptoms following exposure such as a skin rash, you should seek medical advice and show the doctor this warning. Swelling of the face, lips or eyes or difficulty with breathing are more serious symptoms and require urgent medical attention. Wash hands after use.

Adverse reactions

Mild gastrointestinal signs (diarrhoea, and vomiting) have been reported in very rare cases (less than 1 animal in 10,000 animals, including isolated reports) after administration of the product. Treatment may be discontinued depending on the severity of the undesirable effects and a benefit/risk evaluation by the veterinary surgeon.

Allergic reactions (skin reactions, anaphylaxis) have been reported in very rare cases (less than 1 animal in 10,000 animals, including isolated reports). In these cases, administration should be discontinued and a symptomatic treatment given.

Use during pregnancy or lactation

Laboratory studies in rats and mice have not produced any evidence of teratogenic, foetotoxic or maternotoxic effects.

In pregnant and lactating animals, use only according to the benefit/risk assessment by the responsible veterinarian.

Interactions

Chloramphenicol, macrolides, sulfonamides and tetracyclines may inhibit the antibacterial effect of penicillins because of the rapid onset of bacteriostatic action.

Penicillins may increase the effect of aminoglycosides.

Amounts to be administered and administration route

The recommended dose of the product is 10 mg amoxicillin / 2.5 mg clavulanic acid per kg body weight twice a day by the oral route every 12 h, according to the following tables:

In refractory cases the dose may be doubled to 20 mg of amoxicillin / 5 mg clavulanic acid/kg bodyweight twice daily, at the clinician’s discretion.

Duration of therapy

The majority of routine cases respond to 5 – 7 days of therapy. In chronic cases, a longer case of therapy is recommended. In such circumstances overall treatment length must be at the clinician’s discretion, but should be long enough to ensure complete resolution of the bacterial disease.

To ensure the correct dosage, body weight should be determined as accurately as possible to avoid under-dosing.

Overdose

In case of overdose diarrhoea, allergic reactions or further symptoms like central nervous excitation manifestations or cramps could appear. Symptomatic treatment should be initiated when necessary.

Pharmacological particulars

Pharmacodynamic properties

Amoxicillin is a beta-lactam antibiotic and its structure contains the beta-lactam ring and thiazolidine ring common to all penicillins. Amoxicillin shows activity against susceptible Gram-positive bacteria and Gram-negative bacteria.

Beta-lactam antibiotics prevent the bacterial cell wall from forming by interfering with the final stage of peptidoglycan synthesis. They inhibit the activity of transpeptidase enzymes, which catalyse cross-linkage of the glycopeptide polymer units that form the cell wall. They exert a bactericidal action but cause lysis of growing cells only.

Clavulanic acid is one of the naturally occurring metabolites of the streptomycete Streptomyces clavuligerus. It has a structural similarity to the penicillin nucleus, including possession of a beta-lactam ring. Clavulanic acid is a beta-lactamase inhibitor acting initially competitively but ultimately irreversibly. Clavulanic acid will penetrate the bacterial cell wall binding to both extracellular and intracellular beta-lactamases.

Amoxicillin is susceptible to breakdown by ß-lactamase and therefore combination with an effective ß-lactamase inhibitor (clavulanic acid) extends the range of bacteria against which it is active to include ß-lactamase producing species.

In vitro potentiated amoxicillin is active against a wide range of clinically important aerobic and anaerobic bacteria including:

Gram-positive: Staphylococcus spp. (including b-lactamase producing strains), Streptococcus spp

Gram-negative: Escherichia coli (including most b-lactamase producing strains), Pasteurella spp, Proteus spp

Resistance is shown among Enterobacter spp, Pseudomonas aeruginosa and methicillin-resistant Staphylococcus aureus.

A trend in resistance of E. coli is reported.

Pharmacokinetic properties

After oral administration in dogs, amoxicillin and clavulanic acid are rapidly absorbed. Amoxicillin (pKa 2.8) has a relatively small apparent distribution volume, a low plasma protein binding (34% in dogs) and a short terminal half-life due to active tubular excretion via the kidneys. Following absorption the highest concentrations are found in the kidneys (urine) and the bile and then in liver, lungs, heart and spleen. The distribution of amoxicillin to the cerebrospinal fluid is low unless the meninges are inflamed.

Clavulanic acid (pKa 2.7) is also well-absorbed following oral administration. The penetration to the cerebrospinal fluid is poor. The plasma protein binding is approximately 25% and the elimination half-life is short. Clavulanic acid is mainly eliminated by renal excretion (unchanged in urine).

After single oral administration of 17 mg/kg amoxicillin and 4.3 mg/kg clavulanic acid in dogs:

-The maximal plasma concentration (Cmax) of amoxicillin (8.6 µg/mL) was observed 1.5 hour following administration.

-The maximal plasma concentration (Cmax) of clavulanic acid (4.9 µg/mL) was observed 54 minutes following administration.

After single oral administration of 13 mg/kg amoxicillin and 3.15 mg/kg clavulanic acid in cats:

-The maximal plasma concentration (Cmax) of amoxicillin (9.3 µg/mL) was observed 2 hours following administration.

-The maximal plasma concentration (Cmax) of clavulanic acid (4.1 µg/mL) was observed 50 minutes following administration

Pharmaceutical particulars

Shelf life

Any divided tablet portions of Kesium 50 mg, 62.5 mg and 500 mg remaining after 12 hours should be discarded.

Any divided tablet portions of Kesium 250 mg and 625 mg remaining after 36 hours should be discarded.

Special precautions for storage

Do not store above 25°C. Divided tablets should be stored in the blister pack.

Immediate packaging

Kesium 50 mg and 62.5 mg tablets: containing 10 tablets per blister.

Cardboard box with 1 blister of 10 tablets; 2 blisters of 10 tablets; 4 blisters of 10 tablets; 6 blisters of 10 tablets; 8 blisters of 10 tablets; 10 blisters of 10 tablets; 24 blisters of 10 tablets.

Kesium 250 mg tablet: containing 8 tablets per blister.

Cardboard box with 1 blister of 8 tablets; 2 blisters of 8 tablets; 4 blisters of 8 tablets; 6 blisters of 8 tablets; 8 blisters of 8 tablets; 10 blisters of 8 tablets; 12 blisters of 8 tablets; 30 blisters of 8 tablets.

Kesium 500 & 625 mg tablet: containing 6 tablets per blister.

Cardboard box with 1 blister of 6 tablets;2 blisters of 6 tablets; 4 blisters of 6 tablets; 6 blisters of 6 tablets; 8 blisters of 6 tablets; 10 blisters of 6 tablets; 12 blisters of 6 tablets; 14 blisters of 6 tablets; 16 blisters of 6 tablets; 40 blisters of 6 tablets.

Not all pack sizes may be marketed

Disposal

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements

Marketing Authorisation Number

Kesium 50 mg tablet Vm 15052/4132

Kesium 62.5 mg tablet Vm 15052/4134

Kesium 250 mg tablet: Vm 15052/4131

Kesium 500 mg tablet: Vm 15052/4133

Kesium 625mg tablet: Vm 15052/4135

Date of the first authorisation or date of renewal

Kesium 50 mg tablets: 5th October 2011

Kesium 62.5 mg tablets: 5th October 2011

Kesium 250 mg tablets: 5th October 2011

Kesium 500 mg tablets: 5th October 2011

Kesium 625mg tablets: 24th October 2013

Date of revision of the text

August 2016

Any other information

Legal category

500mg » Priced per Tablet

Kesium 50 mg & 62.5 mg chewable tablets for cats & dogs and Kesium 250 mg, 500 mg & 625 mg chewable tablets for dogs

Kesium 50 mg & 62.5 mg chewable tablets for cats & dogs and Kesium 250 mg, 500 mg & 625 mg chewable tablets for dogs

Qualitative and quantitative composition

Each Kesium 50 mg tablet contains: Amoxicillin (as amoxicillin trihydrate) 40.00 mg and clavulanic acid (as potassium clavulanate) 10.00 mg

Each Kesium 62.5mg tablet contains: Amoxicillin (as amoxicillin trihydrate) 50.00 mg and clavulanic acid (as potassium clavulanate) 12.5 mg

Each Kesium 250 mg tablet contains: Amoxicillin (as amoxicillin trihydrate) 200.00 mg and clavulanic acid (as potassium clavulanate) 50.00 mg

Each Kesium 500 mg tablet contains: Amoxicillin (as amoxicillin trihydrate) 400.00 mg and clavulanic acid (as potassium clavulanate) 100 mg

Each Kesium 625 mg tablet contains: Amoxicillin (as amoxicillin trihydrate) 500.00 mg and clavulanic acid (as potassium clavulanate) 125 mg

Pharmaceutical form

Kesium 50 mg, 62.5 mg and 500 mg tablets are oblong, scored, chewable tablets that can be divided into equal halves.

Kesium 250 mg and 625 mg tablets are clover-shaped, beige, chewable tablets that can be divided into four equal parts.

Clinical particulars

Target species

Dogs and cats.

Indications for use

For the treatment of the following infections caused by β lactamase producing strains of bacteria sensitive to amoxicillin in combination with clavulanic acid and where clinical experience and/or sensitivity testing indicates the product as the drug of choice:

-Skin infections (including superficial and deep pyodermas) associated with Staphylococcus spp.

-Urinary tract infections associated with Staphylococcus spp, Streptococcus spp, Escherichia coli and Proteus mirabilis.

-Respiratory tract infections associated with Staphylococcus spp, Streptococcus spp and Pasteurella spp.

-Digestive tract infections associated with Escherichia coli.

-Infections of the oral cavity (mucous membrane) associated with Pasteurella spp, Streptococcus spp, Escherichia coli.

Contraindications

Do not use in animals with known hypersensitivity to penicillins or other susbstances of the β-lactam group or to any excipients.

Do not use in animals with serious dysfunction of the kidneys accompanied by anuria and oliguria.

Do not administer to gerbils, guinea pigs, hamsters, rabbits and chinchillas. Do not use in horses and ruminating animals.

Do not use where resistance to this combination is known to occur.

Special precautions for use in animals

Official, national and regional antimicrobial policies with respect to the use of broad-spectrum antibiotics should be taken into account. Do not use in case of bacteria sensitive to narrow spectrum penicillins or to amoxicillin as single substance. It is advised that upon initiating therapy appropriate sensitivity testing is performed and that therapy is continued only after susceptibility to the combination has been established. Use of the product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to the amoxicillin/clavulanate, and may decrease the effectiveness of treatment with beta-lactam antibiotics.

In animals with hepatic and renal dysfunction, the dosing regimen should be carefully evaluated and the use of the product based on a risk/benefit evaluation by the veterinary surgeon.

Caution is advised in the use in small herbivores other than those indicated in 'Contraindications'.

The potential for allergic cross-reactions with other penicillin derivates and cephalosporins should be considered.

Special precautions to be taken by the person administering the veterinary medicinal product to animals

Penicillins and cephalosporins may cause hypersensitivity (allergy) following injection, inhalation, ingestion or skin contact. Hypersensitivity to penicillins may lead to cross-reactions to cephalosporins and vice versa. Allergic reactions to these substances may occasionally be serious. Do not handle this product if you know you are sensitised, or if you have been advised not to work with such preparations. Handle this product with great care to avoid exposure, taking all recommended precautions. If you develop symptoms following exposure such as a skin rash, you should seek medical advice and show the doctor this warning. Swelling of the face, lips or eyes or difficulty with breathing are more serious symptoms and require urgent medical attention. Wash hands after use.

Adverse reactions

Mild gastrointestinal signs (diarrhoea, and vomiting) have been reported in very rare cases (less than 1 animal in 10,000 animals, including isolated reports) after administration of the product. Treatment may be discontinued depending on the severity of the undesirable effects and a benefit/risk evaluation by the veterinary surgeon.

Allergic reactions (skin reactions, anaphylaxis) have been reported in very rare cases (less than 1 animal in 10,000 animals, including isolated reports). In these cases, administration should be discontinued and a symptomatic treatment given.

Use during pregnancy or lactation

Laboratory studies in rats and mice have not produced any evidence of teratogenic, foetotoxic or maternotoxic effects.

In pregnant and lactating animals, use only according to the benefit/risk assessment by the responsible veterinarian.

Interactions

Chloramphenicol, macrolides, sulfonamides and tetracyclines may inhibit the antibacterial effect of penicillins because of the rapid onset of bacteriostatic action.

Penicillins may increase the effect of aminoglycosides.

Amounts to be administered and administration route

The recommended dose of the product is 10 mg amoxicillin / 2.5 mg clavulanic acid per kg body weight twice a day by the oral route every 12 h, according to the following tables:

In refractory cases the dose may be doubled to 20 mg of amoxicillin / 5 mg clavulanic acid/kg bodyweight twice daily, at the clinician’s discretion.

Duration of therapy

The majority of routine cases respond to 5 – 7 days of therapy. In chronic cases, a longer case of therapy is recommended. In such circumstances overall treatment length must be at the clinician’s discretion, but should be long enough to ensure complete resolution of the bacterial disease.

To ensure the correct dosage, body weight should be determined as accurately as possible to avoid under-dosing.

Overdose

In case of overdose diarrhoea, allergic reactions or further symptoms like central nervous excitation manifestations or cramps could appear. Symptomatic treatment should be initiated when necessary.

Pharmacological particulars

Pharmacodynamic properties

Amoxicillin is a beta-lactam antibiotic and its structure contains the beta-lactam ring and thiazolidine ring common to all penicillins. Amoxicillin shows activity against susceptible Gram-positive bacteria and Gram-negative bacteria.

Beta-lactam antibiotics prevent the bacterial cell wall from forming by interfering with the final stage of peptidoglycan synthesis. They inhibit the activity of transpeptidase enzymes, which catalyse cross-linkage of the glycopeptide polymer units that form the cell wall. They exert a bactericidal action but cause lysis of growing cells only.

Clavulanic acid is one of the naturally occurring metabolites of the streptomycete Streptomyces clavuligerus. It has a structural similarity to the penicillin nucleus, including possession of a beta-lactam ring. Clavulanic acid is a beta-lactamase inhibitor acting initially competitively but ultimately irreversibly. Clavulanic acid will penetrate the bacterial cell wall binding to both extracellular and intracellular beta-lactamases.

Amoxicillin is susceptible to breakdown by ß-lactamase and therefore combination with an effective ß-lactamase inhibitor (clavulanic acid) extends the range of bacteria against which it is active to include ß-lactamase producing species.

In vitro potentiated amoxicillin is active against a wide range of clinically important aerobic and anaerobic bacteria including:

Gram-positive: Staphylococcus spp. (including b-lactamase producing strains), Streptococcus spp

Gram-negative: Escherichia coli (including most b-lactamase producing strains), Pasteurella spp, Proteus spp

Resistance is shown among Enterobacter spp, Pseudomonas aeruginosa and methicillin-resistant Staphylococcus aureus.

A trend in resistance of E. coli is reported.

Pharmacokinetic properties

After oral administration in dogs, amoxicillin and clavulanic acid are rapidly absorbed. Amoxicillin (pKa 2.8) has a relatively small apparent distribution volume, a low plasma protein binding (34% in dogs) and a short terminal half-life due to active tubular excretion via the kidneys. Following absorption the highest concentrations are found in the kidneys (urine) and the bile and then in liver, lungs, heart and spleen. The distribution of amoxicillin to the cerebrospinal fluid is low unless the meninges are inflamed.

Clavulanic acid (pKa 2.7) is also well-absorbed following oral administration. The penetration to the cerebrospinal fluid is poor. The plasma protein binding is approximately 25% and the elimination half-life is short. Clavulanic acid is mainly eliminated by renal excretion (unchanged in urine).

After single oral administration of 17 mg/kg amoxicillin and 4.3 mg/kg clavulanic acid in dogs:

-The maximal plasma concentration (Cmax) of amoxicillin (8.6 µg/mL) was observed 1.5 hour following administration.

-The maximal plasma concentration (Cmax) of clavulanic acid (4.9 µg/mL) was observed 54 minutes following administration.

After single oral administration of 13 mg/kg amoxicillin and 3.15 mg/kg clavulanic acid in cats:

-The maximal plasma concentration (Cmax) of amoxicillin (9.3 µg/mL) was observed 2 hours following administration.

-The maximal plasma concentration (Cmax) of clavulanic acid (4.1 µg/mL) was observed 50 minutes following administration

Pharmaceutical particulars

Shelf life

Any divided tablet portions of Kesium 50 mg, 62.5 mg and 500 mg remaining after 12 hours should be discarded.

Any divided tablet portions of Kesium 250 mg and 625 mg remaining after 36 hours should be discarded.

Special precautions for storage

Do not store above 25°C. Divided tablets should be stored in the blister pack.

Immediate packaging

Kesium 50 mg and 62.5 mg tablets: containing 10 tablets per blister.

Cardboard box with 1 blister of 10 tablets; 2 blisters of 10 tablets; 4 blisters of 10 tablets; 6 blisters of 10 tablets; 8 blisters of 10 tablets; 10 blisters of 10 tablets; 24 blisters of 10 tablets.

Kesium 250 mg tablet: containing 8 tablets per blister.

Cardboard box with 1 blister of 8 tablets; 2 blisters of 8 tablets; 4 blisters of 8 tablets; 6 blisters of 8 tablets; 8 blisters of 8 tablets; 10 blisters of 8 tablets; 12 blisters of 8 tablets; 30 blisters of 8 tablets.

Kesium 500 & 625 mg tablet: containing 6 tablets per blister.

Cardboard box with 1 blister of 6 tablets;2 blisters of 6 tablets; 4 blisters of 6 tablets; 6 blisters of 6 tablets; 8 blisters of 6 tablets; 10 blisters of 6 tablets; 12 blisters of 6 tablets; 14 blisters of 6 tablets; 16 blisters of 6 tablets; 40 blisters of 6 tablets.

Not all pack sizes may be marketed

Disposal

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements

Marketing Authorisation Number

Kesium 50 mg tablet Vm 15052/4132

Kesium 62.5 mg tablet Vm 15052/4134

Kesium 250 mg tablet: Vm 15052/4131

Kesium 500 mg tablet: Vm 15052/4133

Kesium 625mg tablet: Vm 15052/4135

Date of the first authorisation or date of renewal

Kesium 50 mg tablets: 5th October 2011

Kesium 62.5 mg tablets: 5th October 2011

Kesium 250 mg tablets: 5th October 2011

Kesium 500 mg tablets: 5th October 2011

Kesium 625mg tablets: 24th October 2013

Date of revision of the text

August 2016

Any other information

Legal category

50mg » Priced per tablet

Kesium 50 mg & 62.5 mg chewable tablets for cats & dogs and Kesium 250 mg, 500 mg & 625 mg chewable tablets for dogs

Kesium 50 mg & 62.5 mg chewable tablets for cats & dogs and Kesium 250 mg, 500 mg & 625 mg chewable tablets for dogs

Qualitative and quantitative composition

Each Kesium 50 mg tablet contains: Amoxicillin (as amoxicillin trihydrate) 40.00 mg and clavulanic acid (as potassium clavulanate) 10.00 mg

Each Kesium 62.5mg tablet contains: Amoxicillin (as amoxicillin trihydrate) 50.00 mg and clavulanic acid (as potassium clavulanate) 12.5 mg

Each Kesium 250 mg tablet contains: Amoxicillin (as amoxicillin trihydrate) 200.00 mg and clavulanic acid (as potassium clavulanate) 50.00 mg

Each Kesium 500 mg tablet contains: Amoxicillin (as amoxicillin trihydrate) 400.00 mg and clavulanic acid (as potassium clavulanate) 100 mg

Each Kesium 625 mg tablet contains: Amoxicillin (as amoxicillin trihydrate) 500.00 mg and clavulanic acid (as potassium clavulanate) 125 mg

Pharmaceutical form

Kesium 50 mg, 62.5 mg and 500 mg tablets are oblong, scored, chewable tablets that can be divided into equal halves.

Kesium 250 mg and 625 mg tablets are clover-shaped, beige, chewable tablets that can be divided into four equal parts.

Clinical particulars

Target species

Dogs and cats.

Indications for use

For the treatment of the following infections caused by β lactamase producing strains of bacteria sensitive to amoxicillin in combination with clavulanic acid and where clinical experience and/or sensitivity testing indicates the product as the drug of choice:

-Skin infections (including superficial and deep pyodermas) associated with Staphylococcus spp.

-Urinary tract infections associated with Staphylococcus spp, Streptococcus spp, Escherichia coli and Proteus mirabilis.

-Respiratory tract infections associated with Staphylococcus spp, Streptococcus spp and Pasteurella spp.

-Digestive tract infections associated with Escherichia coli.

-Infections of the oral cavity (mucous membrane) associated with Pasteurella spp, Streptococcus spp, Escherichia coli.

Contraindications

Do not use in animals with known hypersensitivity to penicillins or other susbstances of the β-lactam group or to any excipients.

Do not use in animals with serious dysfunction of the kidneys accompanied by anuria and oliguria.

Do not administer to gerbils, guinea pigs, hamsters, rabbits and chinchillas. Do not use in horses and ruminating animals.

Do not use where resistance to this combination is known to occur.

Special precautions for use in animals

Official, national and regional antimicrobial policies with respect to the use of broad-spectrum antibiotics should be taken into account. Do not use in case of bacteria sensitive to narrow spectrum penicillins or to amoxicillin as single substance. It is advised that upon initiating therapy appropriate sensitivity testing is performed and that therapy is continued only after susceptibility to the combination has been established. Use of the product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to the amoxicillin/clavulanate, and may decrease the effectiveness of treatment with beta-lactam antibiotics.

In animals with hepatic and renal dysfunction, the dosing regimen should be carefully evaluated and the use of the product based on a risk/benefit evaluation by the veterinary surgeon.

Caution is advised in the use in small herbivores other than those indicated in 'Contraindications'.

The potential for allergic cross-reactions with other penicillin derivates and cephalosporins should be considered.

Special precautions to be taken by the person administering the veterinary medicinal product to animals

Penicillins and cephalosporins may cause hypersensitivity (allergy) following injection, inhalation, ingestion or skin contact. Hypersensitivity to penicillins may lead to cross-reactions to cephalosporins and vice versa. Allergic reactions to these substances may occasionally be serious. Do not handle this product if you know you are sensitised, or if you have been advised not to work with such preparations. Handle this product with great care to avoid exposure, taking all recommended precautions. If you develop symptoms following exposure such as a skin rash, you should seek medical advice and show the doctor this warning. Swelling of the face, lips or eyes or difficulty with breathing are more serious symptoms and require urgent medical attention. Wash hands after use.

Adverse reactions

Mild gastrointestinal signs (diarrhoea, and vomiting) have been reported in very rare cases (less than 1 animal in 10,000 animals, including isolated reports) after administration of the product. Treatment may be discontinued depending on the severity of the undesirable effects and a benefit/risk evaluation by the veterinary surgeon.

Allergic reactions (skin reactions, anaphylaxis) have been reported in very rare cases (less than 1 animal in 10,000 animals, including isolated reports). In these cases, administration should be discontinued and a symptomatic treatment given.

Use during pregnancy or lactation

Laboratory studies in rats and mice have not produced any evidence of teratogenic, foetotoxic or maternotoxic effects.

In pregnant and lactating animals, use only according to the benefit/risk assessment by the responsible veterinarian.

Interactions

Chloramphenicol, macrolides, sulfonamides and tetracyclines may inhibit the antibacterial effect of penicillins because of the rapid onset of bacteriostatic action.

Penicillins may increase the effect of aminoglycosides.

Amounts to be administered and administration route

The recommended dose of the product is 10 mg amoxicillin / 2.5 mg clavulanic acid per kg body weight twice a day by the oral route every 12 h, according to the following tables:

In refractory cases the dose may be doubled to 20 mg of amoxicillin / 5 mg clavulanic acid/kg bodyweight twice daily, at the clinician’s discretion.

Duration of therapy

The majority of routine cases respond to 5 – 7 days of therapy. In chronic cases, a longer case of therapy is recommended. In such circumstances overall treatment length must be at the clinician’s discretion, but should be long enough to ensure complete resolution of the bacterial disease.

To ensure the correct dosage, body weight should be determined as accurately as possible to avoid under-dosing.

Overdose

In case of overdose diarrhoea, allergic reactions or further symptoms like central nervous excitation manifestations or cramps could appear. Symptomatic treatment should be initiated when necessary.

Pharmacological particulars

Pharmacodynamic properties

Amoxicillin is a beta-lactam antibiotic and its structure contains the beta-lactam ring and thiazolidine ring common to all penicillins. Amoxicillin shows activity against susceptible Gram-positive bacteria and Gram-negative bacteria.

Beta-lactam antibiotics prevent the bacterial cell wall from forming by interfering with the final stage of peptidoglycan synthesis. They inhibit the activity of transpeptidase enzymes, which catalyse cross-linkage of the glycopeptide polymer units that form the cell wall. They exert a bactericidal action but cause lysis of growing cells only.

Clavulanic acid is one of the naturally occurring metabolites of the streptomycete Streptomyces clavuligerus. It has a structural similarity to the penicillin nucleus, including possession of a beta-lactam ring. Clavulanic acid is a beta-lactamase inhibitor acting initially competitively but ultimately irreversibly. Clavulanic acid will penetrate the bacterial cell wall binding to both extracellular and intracellular beta-lactamases.

Amoxicillin is susceptible to breakdown by ß-lactamase and therefore combination with an effective ß-lactamase inhibitor (clavulanic acid) extends the range of bacteria against which it is active to include ß-lactamase producing species.

In vitro potentiated amoxicillin is active against a wide range of clinically important aerobic and anaerobic bacteria including:

Gram-positive: Staphylococcus spp. (including b-lactamase producing strains), Streptococcus spp

Gram-negative: Escherichia coli (including most b-lactamase producing strains), Pasteurella spp, Proteus spp

Resistance is shown among Enterobacter spp, Pseudomonas aeruginosa and methicillin-resistant Staphylococcus aureus.

A trend in resistance of E. coli is reported.

Pharmacokinetic properties

After oral administration in dogs, amoxicillin and clavulanic acid are rapidly absorbed. Amoxicillin (pKa 2.8) has a relatively small apparent distribution volume, a low plasma protein binding (34% in dogs) and a short terminal half-life due to active tubular excretion via the kidneys. Following absorption the highest concentrations are found in the kidneys (urine) and the bile and then in liver, lungs, heart and spleen. The distribution of amoxicillin to the cerebrospinal fluid is low unless the meninges are inflamed.

Clavulanic acid (pKa 2.7) is also well-absorbed following oral administration. The penetration to the cerebrospinal fluid is poor. The plasma protein binding is approximately 25% and the elimination half-life is short. Clavulanic acid is mainly eliminated by renal excretion (unchanged in urine).

After single oral administration of 17 mg/kg amoxicillin and 4.3 mg/kg clavulanic acid in dogs:

-The maximal plasma concentration (Cmax) of amoxicillin (8.6 µg/mL) was observed 1.5 hour following administration.

-The maximal plasma concentration (Cmax) of clavulanic acid (4.9 µg/mL) was observed 54 minutes following administration.

After single oral administration of 13 mg/kg amoxicillin and 3.15 mg/kg clavulanic acid in cats:

-The maximal plasma concentration (Cmax) of amoxicillin (9.3 µg/mL) was observed 2 hours following administration.

-The maximal plasma concentration (Cmax) of clavulanic acid (4.1 µg/mL) was observed 50 minutes following administration

Pharmaceutical particulars

Shelf life

Any divided tablet portions of Kesium 50 mg, 62.5 mg and 500 mg remaining after 12 hours should be discarded.

Any divided tablet portions of Kesium 250 mg and 625 mg remaining after 36 hours should be discarded.

Special precautions for storage

Do not store above 25°C. Divided tablets should be stored in the blister pack.

Immediate packaging

Kesium 50 mg and 62.5 mg tablets: containing 10 tablets per blister.

Cardboard box with 1 blister of 10 tablets; 2 blisters of 10 tablets; 4 blisters of 10 tablets; 6 blisters of 10 tablets; 8 blisters of 10 tablets; 10 blisters of 10 tablets; 24 blisters of 10 tablets.

Kesium 250 mg tablet: containing 8 tablets per blister.

Cardboard box with 1 blister of 8 tablets; 2 blisters of 8 tablets; 4 blisters of 8 tablets; 6 blisters of 8 tablets; 8 blisters of 8 tablets; 10 blisters of 8 tablets; 12 blisters of 8 tablets; 30 blisters of 8 tablets.

Kesium 500 & 625 mg tablet: containing 6 tablets per blister.

Cardboard box with 1 blister of 6 tablets;2 blisters of 6 tablets; 4 blisters of 6 tablets; 6 blisters of 6 tablets; 8 blisters of 6 tablets; 10 blisters of 6 tablets; 12 blisters of 6 tablets; 14 blisters of 6 tablets; 16 blisters of 6 tablets; 40 blisters of 6 tablets.

Not all pack sizes may be marketed

Disposal

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements

Marketing Authorisation Number

Kesium 50 mg tablet Vm 15052/4132

Kesium 62.5 mg tablet Vm 15052/4134

Kesium 250 mg tablet: Vm 15052/4131

Kesium 500 mg tablet: Vm 15052/4133

Kesium 625mg tablet: Vm 15052/4135

Date of the first authorisation or date of renewal

Kesium 50 mg tablets: 5th October 2011

Kesium 62.5 mg tablets: 5th October 2011

Kesium 250 mg tablets: 5th October 2011

Kesium 500 mg tablets: 5th October 2011

Kesium 625mg tablets: 24th October 2013

Date of revision of the text

August 2016

Any other information

Legal category

62.5mg » Priced per tablet

Kesium 50 mg & 62.5 mg chewable tablets for cats & dogs and Kesium 250 mg, 500 mg & 625 mg chewable tablets for dogs

Kesium 50 mg & 62.5 mg chewable tablets for cats & dogs and Kesium 250 mg, 500 mg & 625 mg chewable tablets for dogs

Qualitative and quantitative composition

Each Kesium 50 mg tablet contains: Amoxicillin (as amoxicillin trihydrate) 40.00 mg and clavulanic acid (as potassium clavulanate) 10.00 mg

Each Kesium 62.5mg tablet contains: Amoxicillin (as amoxicillin trihydrate) 50.00 mg and clavulanic acid (as potassium clavulanate) 12.5 mg

Each Kesium 250 mg tablet contains: Amoxicillin (as amoxicillin trihydrate) 200.00 mg and clavulanic acid (as potassium clavulanate) 50.00 mg

Each Kesium 500 mg tablet contains: Amoxicillin (as amoxicillin trihydrate) 400.00 mg and clavulanic acid (as potassium clavulanate) 100 mg

Each Kesium 625 mg tablet contains: Amoxicillin (as amoxicillin trihydrate) 500.00 mg and clavulanic acid (as potassium clavulanate) 125 mg

Pharmaceutical form

Kesium 50 mg, 62.5 mg and 500 mg tablets are oblong, scored, chewable tablets that can be divided into equal halves.

Kesium 250 mg and 625 mg tablets are clover-shaped, beige, chewable tablets that can be divided into four equal parts.

Clinical particulars

Target species

Dogs and cats.

Indications for use

For the treatment of the following infections caused by β lactamase producing strains of bacteria sensitive to amoxicillin in combination with clavulanic acid and where clinical experience and/or sensitivity testing indicates the product as the drug of choice:

-Skin infections (including superficial and deep pyodermas) associated with Staphylococcus spp.

-Urinary tract infections associated with Staphylococcus spp, Streptococcus spp, Escherichia coli and Proteus mirabilis.

-Respiratory tract infections associated with Staphylococcus spp, Streptococcus spp and Pasteurella spp.

-Digestive tract infections associated with Escherichia coli.

-Infections of the oral cavity (mucous membrane) associated with Pasteurella spp, Streptococcus spp, Escherichia coli.

Contraindications

Do not use in animals with known hypersensitivity to penicillins or other susbstances of the β-lactam group or to any excipients.

Do not use in animals with serious dysfunction of the kidneys accompanied by anuria and oliguria.

Do not administer to gerbils, guinea pigs, hamsters, rabbits and chinchillas. Do not use in horses and ruminating animals.

Do not use where resistance to this combination is known to occur.

Special precautions for use in animals

Official, national and regional antimicrobial policies with respect to the use of broad-spectrum antibiotics should be taken into account. Do not use in case of bacteria sensitive to narrow spectrum penicillins or to amoxicillin as single substance. It is advised that upon initiating therapy appropriate sensitivity testing is performed and that therapy is continued only after susceptibility to the combination has been established. Use of the product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to the amoxicillin/clavulanate, and may decrease the effectiveness of treatment with beta-lactam antibiotics.

In animals with hepatic and renal dysfunction, the dosing regimen should be carefully evaluated and the use of the product based on a risk/benefit evaluation by the veterinary surgeon.

Caution is advised in the use in small herbivores other than those indicated in 'Contraindications'.

The potential for allergic cross-reactions with other penicillin derivates and cephalosporins should be considered.

Special precautions to be taken by the person administering the veterinary medicinal product to animals

Penicillins and cephalosporins may cause hypersensitivity (allergy) following injection, inhalation, ingestion or skin contact. Hypersensitivity to penicillins may lead to cross-reactions to cephalosporins and vice versa. Allergic reactions to these substances may occasionally be serious. Do not handle this product if you know you are sensitised, or if you have been advised not to work with such preparations. Handle this product with great care to avoid exposure, taking all recommended precautions. If you develop symptoms following exposure such as a skin rash, you should seek medical advice and show the doctor this warning. Swelling of the face, lips or eyes or difficulty with breathing are more serious symptoms and require urgent medical attention. Wash hands after use.

Adverse reactions

Mild gastrointestinal signs (diarrhoea, and vomiting) have been reported in very rare cases (less than 1 animal in 10,000 animals, including isolated reports) after administration of the product. Treatment may be discontinued depending on the severity of the undesirable effects and a benefit/risk evaluation by the veterinary surgeon.

Allergic reactions (skin reactions, anaphylaxis) have been reported in very rare cases (less than 1 animal in 10,000 animals, including isolated reports). In these cases, administration should be discontinued and a symptomatic treatment given.

Use during pregnancy or lactation

Laboratory studies in rats and mice have not produced any evidence of teratogenic, foetotoxic or maternotoxic effects.

In pregnant and lactating animals, use only according to the benefit/risk assessment by the responsible veterinarian.

Interactions

Chloramphenicol, macrolides, sulfonamides and tetracyclines may inhibit the antibacterial effect of penicillins because of the rapid onset of bacteriostatic action.

Penicillins may increase the effect of aminoglycosides.

Amounts to be administered and administration route

The recommended dose of the product is 10 mg amoxicillin / 2.5 mg clavulanic acid per kg body weight twice a day by the oral route every 12 h, according to the following tables:

In refractory cases the dose may be doubled to 20 mg of amoxicillin / 5 mg clavulanic acid/kg bodyweight twice daily, at the clinician’s discretion.

Duration of therapy

The majority of routine cases respond to 5 – 7 days of therapy. In chronic cases, a longer case of therapy is recommended. In such circumstances overall treatment length must be at the clinician’s discretion, but should be long enough to ensure complete resolution of the bacterial disease.

To ensure the correct dosage, body weight should be determined as accurately as possible to avoid under-dosing.

Overdose

In case of overdose diarrhoea, allergic reactions or further symptoms like central nervous excitation manifestations or cramps could appear. Symptomatic treatment should be initiated when necessary.

Pharmacological particulars

Pharmacodynamic properties

Amoxicillin is a beta-lactam antibiotic and its structure contains the beta-lactam ring and thiazolidine ring common to all penicillins. Amoxicillin shows activity against susceptible Gram-positive bacteria and Gram-negative bacteria.

Beta-lactam antibiotics prevent the bacterial cell wall from forming by interfering with the final stage of peptidoglycan synthesis. They inhibit the activity of transpeptidase enzymes, which catalyse cross-linkage of the glycopeptide polymer units that form the cell wall. They exert a bactericidal action but cause lysis of growing cells only.

Clavulanic acid is one of the naturally occurring metabolites of the streptomycete Streptomyces clavuligerus. It has a structural similarity to the penicillin nucleus, including possession of a beta-lactam ring. Clavulanic acid is a beta-lactamase inhibitor acting initially competitively but ultimately irreversibly. Clavulanic acid will penetrate the bacterial cell wall binding to both extracellular and intracellular beta-lactamases.

Amoxicillin is susceptible to breakdown by ß-lactamase and therefore combination with an effective ß-lactamase inhibitor (clavulanic acid) extends the range of bacteria against which it is active to include ß-lactamase producing species.

In vitro potentiated amoxicillin is active against a wide range of clinically important aerobic and anaerobic bacteria including:

Gram-positive: Staphylococcus spp. (including b-lactamase producing strains), Streptococcus spp

Gram-negative: Escherichia coli (including most b-lactamase producing strains), Pasteurella spp, Proteus spp

Resistance is shown among Enterobacter spp, Pseudomonas aeruginosa and methicillin-resistant Staphylococcus aureus.

A trend in resistance of E. coli is reported.

Pharmacokinetic properties

After oral administration in dogs, amoxicillin and clavulanic acid are rapidly absorbed. Amoxicillin (pKa 2.8) has a relatively small apparent distribution volume, a low plasma protein binding (34% in dogs) and a short terminal half-life due to active tubular excretion via the kidneys. Following absorption the highest concentrations are found in the kidneys (urine) and the bile and then in liver, lungs, heart and spleen. The distribution of amoxicillin to the cerebrospinal fluid is low unless the meninges are inflamed.

Clavulanic acid (pKa 2.7) is also well-absorbed following oral administration. The penetration to the cerebrospinal fluid is poor. The plasma protein binding is approximately 25% and the elimination half-life is short. Clavulanic acid is mainly eliminated by renal excretion (unchanged in urine).

After single oral administration of 17 mg/kg amoxicillin and 4.3 mg/kg clavulanic acid in dogs:

-The maximal plasma concentration (Cmax) of amoxicillin (8.6 µg/mL) was observed 1.5 hour following administration.

-The maximal plasma concentration (Cmax) of clavulanic acid (4.9 µg/mL) was observed 54 minutes following administration.

After single oral administration of 13 mg/kg amoxicillin and 3.15 mg/kg clavulanic acid in cats:

-The maximal plasma concentration (Cmax) of amoxicillin (9.3 µg/mL) was observed 2 hours following administration.

-The maximal plasma concentration (Cmax) of clavulanic acid (4.1 µg/mL) was observed 50 minutes following administration

Pharmaceutical particulars

Shelf life

Any divided tablet portions of Kesium 50 mg, 62.5 mg and 500 mg remaining after 12 hours should be discarded.

Any divided tablet portions of Kesium 250 mg and 625 mg remaining after 36 hours should be discarded.

Special precautions for storage

Do not store above 25°C. Divided tablets should be stored in the blister pack.

Immediate packaging

Kesium 50 mg and 62.5 mg tablets: containing 10 tablets per blister.

Cardboard box with 1 blister of 10 tablets; 2 blisters of 10 tablets; 4 blisters of 10 tablets; 6 blisters of 10 tablets; 8 blisters of 10 tablets; 10 blisters of 10 tablets; 24 blisters of 10 tablets.

Kesium 250 mg tablet: containing 8 tablets per blister.

Cardboard box with 1 blister of 8 tablets; 2 blisters of 8 tablets; 4 blisters of 8 tablets; 6 blisters of 8 tablets; 8 blisters of 8 tablets; 10 blisters of 8 tablets; 12 blisters of 8 tablets; 30 blisters of 8 tablets.

Kesium 500 & 625 mg tablet: containing 6 tablets per blister.

Cardboard box with 1 blister of 6 tablets;2 blisters of 6 tablets; 4 blisters of 6 tablets; 6 blisters of 6 tablets; 8 blisters of 6 tablets; 10 blisters of 6 tablets; 12 blisters of 6 tablets; 14 blisters of 6 tablets; 16 blisters of 6 tablets; 40 blisters of 6 tablets.

Not all pack sizes may be marketed

Disposal

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements

Marketing Authorisation Number

Kesium 50 mg tablet Vm 15052/4132

Kesium 62.5 mg tablet Vm 15052/4134

Kesium 250 mg tablet: Vm 15052/4131

Kesium 500 mg tablet: Vm 15052/4133

Kesium 625mg tablet: Vm 15052/4135

Date of the first authorisation or date of renewal

Kesium 50 mg tablets: 5th October 2011

Kesium 62.5 mg tablets: 5th October 2011

Kesium 250 mg tablets: 5th October 2011

Kesium 500 mg tablets: 5th October 2011

Kesium 625mg tablets: 24th October 2013

Date of revision of the text

August 2016

Any other information

Legal category

625mg » Priced per Tablet

Kesium 50 mg & 62.5 mg chewable tablets for cats & dogs and Kesium 250 mg, 500 mg & 625 mg chewable tablets for dogs

Kesium 50 mg & 62.5 mg chewable tablets for cats & dogs and Kesium 250 mg, 500 mg & 625 mg chewable tablets for dogs

Qualitative and quantitative composition

Each Kesium 50 mg tablet contains: Amoxicillin (as amoxicillin trihydrate) 40.00 mg and clavulanic acid (as potassium clavulanate) 10.00 mg

Each Kesium 62.5mg tablet contains: Amoxicillin (as amoxicillin trihydrate) 50.00 mg and clavulanic acid (as potassium clavulanate) 12.5 mg

Each Kesium 250 mg tablet contains: Amoxicillin (as amoxicillin trihydrate) 200.00 mg and clavulanic acid (as potassium clavulanate) 50.00 mg

Each Kesium 500 mg tablet contains: Amoxicillin (as amoxicillin trihydrate) 400.00 mg and clavulanic acid (as potassium clavulanate) 100 mg

Each Kesium 625 mg tablet contains: Amoxicillin (as amoxicillin trihydrate) 500.00 mg and clavulanic acid (as potassium clavulanate) 125 mg

Pharmaceutical form

Kesium 50 mg, 62.5 mg and 500 mg tablets are oblong, scored, chewable tablets that can be divided into equal halves.

Kesium 250 mg and 625 mg tablets are clover-shaped, beige, chewable tablets that can be divided into four equal parts.

Clinical particulars

Target species

Dogs and cats.

Indications for use

For the treatment of the following infections caused by β lactamase producing strains of bacteria sensitive to amoxicillin in combination with clavulanic acid and where clinical experience and/or sensitivity testing indicates the product as the drug of choice:

-Skin infections (including superficial and deep pyodermas) associated with Staphylococcus spp.

-Urinary tract infections associated with Staphylococcus spp, Streptococcus spp, Escherichia coli and Proteus mirabilis.

-Respiratory tract infections associated with Staphylococcus spp, Streptococcus spp and Pasteurella spp.

-Digestive tract infections associated with Escherichia coli.

-Infections of the oral cavity (mucous membrane) associated with Pasteurella spp, Streptococcus spp, Escherichia coli.

Contraindications

Do not use in animals with known hypersensitivity to penicillins or other susbstances of the β-lactam group or to any excipients.

Do not use in animals with serious dysfunction of the kidneys accompanied by anuria and oliguria.

Do not administer to gerbils, guinea pigs, hamsters, rabbits and chinchillas. Do not use in horses and ruminating animals.

Do not use where resistance to this combination is known to occur.

Special precautions for use in animals

Official, national and regional antimicrobial policies with respect to the use of broad-spectrum antibiotics should be taken into account. Do not use in case of bacteria sensitive to narrow spectrum penicillins or to amoxicillin as single substance. It is advised that upon initiating therapy appropriate sensitivity testing is performed and that therapy is continued only after susceptibility to the combination has been established. Use of the product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to the amoxicillin/clavulanate, and may decrease the effectiveness of treatment with beta-lactam antibiotics.

In animals with hepatic and renal dysfunction, the dosing regimen should be carefully evaluated and the use of the product based on a risk/benefit evaluation by the veterinary surgeon.

Caution is advised in the use in small herbivores other than those indicated in 'Contraindications'.

The potential for allergic cross-reactions with other penicillin derivates and cephalosporins should be considered.

Special precautions to be taken by the person administering the veterinary medicinal product to animals

Penicillins and cephalosporins may cause hypersensitivity (allergy) following injection, inhalation, ingestion or skin contact. Hypersensitivity to penicillins may lead to cross-reactions to cephalosporins and vice versa. Allergic reactions to these substances may occasionally be serious. Do not handle this product if you know you are sensitised, or if you have been advised not to work with such preparations. Handle this product with great care to avoid exposure, taking all recommended precautions. If you develop symptoms following exposure such as a skin rash, you should seek medical advice and show the doctor this warning. Swelling of the face, lips or eyes or difficulty with breathing are more serious symptoms and require urgent medical attention. Wash hands after use.

Adverse reactions

Mild gastrointestinal signs (diarrhoea, and vomiting) have been reported in very rare cases (less than 1 animal in 10,000 animals, including isolated reports) after administration of the product. Treatment may be discontinued depending on the severity of the undesirable effects and a benefit/risk evaluation by the veterinary surgeon.

Allergic reactions (skin reactions, anaphylaxis) have been reported in very rare cases (less than 1 animal in 10,000 animals, including isolated reports). In these cases, administration should be discontinued and a symptomatic treatment given.

Use during pregnancy or lactation

Laboratory studies in rats and mice have not produced any evidence of teratogenic, foetotoxic or maternotoxic effects.

In pregnant and lactating animals, use only according to the benefit/risk assessment by the responsible veterinarian.

Interactions

Chloramphenicol, macrolides, sulfonamides and tetracyclines may inhibit the antibacterial effect of penicillins because of the rapid onset of bacteriostatic action.

Penicillins may increase the effect of aminoglycosides.

Amounts to be administered and administration route

The recommended dose of the product is 10 mg amoxicillin / 2.5 mg clavulanic acid per kg body weight twice a day by the oral route every 12 h, according to the following tables:

In refractory cases the dose may be doubled to 20 mg of amoxicillin / 5 mg clavulanic acid/kg bodyweight twice daily, at the clinician’s discretion.

Duration of therapy

The majority of routine cases respond to 5 – 7 days of therapy. In chronic cases, a longer case of therapy is recommended. In such circumstances overall treatment length must be at the clinician’s discretion, but should be long enough to ensure complete resolution of the bacterial disease.

To ensure the correct dosage, body weight should be determined as accurately as possible to avoid under-dosing.

Overdose

In case of overdose diarrhoea, allergic reactions or further symptoms like central nervous excitation manifestations or cramps could appear. Symptomatic treatment should be initiated when necessary.

Pharmacological particulars

Pharmacodynamic properties

Amoxicillin is a beta-lactam antibiotic and its structure contains the beta-lactam ring and thiazolidine ring common to all penicillins. Amoxicillin shows activity against susceptible Gram-positive bacteria and Gram-negative bacteria.

Beta-lactam antibiotics prevent the bacterial cell wall from forming by interfering with the final stage of peptidoglycan synthesis. They inhibit the activity of transpeptidase enzymes, which catalyse cross-linkage of the glycopeptide polymer units that form the cell wall. They exert a bactericidal action but cause lysis of growing cells only.

Clavulanic acid is one of the naturally occurring metabolites of the streptomycete Streptomyces clavuligerus. It has a structural similarity to the penicillin nucleus, including possession of a beta-lactam ring. Clavulanic acid is a beta-lactamase inhibitor acting initially competitively but ultimately irreversibly. Clavulanic acid will penetrate the bacterial cell wall binding to both extracellular and intracellular beta-lactamases.

Amoxicillin is susceptible to breakdown by ß-lactamase and therefore combination with an effective ß-lactamase inhibitor (clavulanic acid) extends the range of bacteria against which it is active to include ß-lactamase producing species.

In vitro potentiated amoxicillin is active against a wide range of clinically important aerobic and anaerobic bacteria including:

Gram-positive: Staphylococcus spp. (including b-lactamase producing strains), Streptococcus spp

Gram-negative: Escherichia coli (including most b-lactamase producing strains), Pasteurella spp, Proteus spp

Resistance is shown among Enterobacter spp, Pseudomonas aeruginosa and methicillin-resistant Staphylococcus aureus.

A trend in resistance of E. coli is reported.

Pharmacokinetic properties

After oral administration in dogs, amoxicillin and clavulanic acid are rapidly absorbed. Amoxicillin (pKa 2.8) has a relatively small apparent distribution volume, a low plasma protein binding (34% in dogs) and a short terminal half-life due to active tubular excretion via the kidneys. Following absorption the highest concentrations are found in the kidneys (urine) and the bile and then in liver, lungs, heart and spleen. The distribution of amoxicillin to the cerebrospinal fluid is low unless the meninges are inflamed.

Clavulanic acid (pKa 2.7) is also well-absorbed following oral administration. The penetration to the cerebrospinal fluid is poor. The plasma protein binding is approximately 25% and the elimination half-life is short. Clavulanic acid is mainly eliminated by renal excretion (unchanged in urine).

After single oral administration of 17 mg/kg amoxicillin and 4.3 mg/kg clavulanic acid in dogs:

-The maximal plasma concentration (Cmax) of amoxicillin (8.6 µg/mL) was observed 1.5 hour following administration.

-The maximal plasma concentration (Cmax) of clavulanic acid (4.9 µg/mL) was observed 54 minutes following administration.

After single oral administration of 13 mg/kg amoxicillin and 3.15 mg/kg clavulanic acid in cats:

-The maximal plasma concentration (Cmax) of amoxicillin (9.3 µg/mL) was observed 2 hours following administration.

-The maximal plasma concentration (Cmax) of clavulanic acid (4.1 µg/mL) was observed 50 minutes following administration

Pharmaceutical particulars

Shelf life

Any divided tablet portions of Kesium 50 mg, 62.5 mg and 500 mg remaining after 12 hours should be discarded.

Any divided tablet portions of Kesium 250 mg and 625 mg remaining after 36 hours should be discarded.

Special precautions for storage

Do not store above 25°C. Divided tablets should be stored in the blister pack.

Immediate packaging

Kesium 50 mg and 62.5 mg tablets: containing 10 tablets per blister.

Cardboard box with 1 blister of 10 tablets; 2 blisters of 10 tablets; 4 blisters of 10 tablets; 6 blisters of 10 tablets; 8 blisters of 10 tablets; 10 blisters of 10 tablets; 24 blisters of 10 tablets.

Kesium 250 mg tablet: containing 8 tablets per blister.

Cardboard box with 1 blister of 8 tablets; 2 blisters of 8 tablets; 4 blisters of 8 tablets; 6 blisters of 8 tablets; 8 blisters of 8 tablets; 10 blisters of 8 tablets; 12 blisters of 8 tablets; 30 blisters of 8 tablets.

Kesium 500 & 625 mg tablet: containing 6 tablets per blister.

Cardboard box with 1 blister of 6 tablets;2 blisters of 6 tablets; 4 blisters of 6 tablets; 6 blisters of 6 tablets; 8 blisters of 6 tablets; 10 blisters of 6 tablets; 12 blisters of 6 tablets; 14 blisters of 6 tablets; 16 blisters of 6 tablets; 40 blisters of 6 tablets.

Not all pack sizes may be marketed

Disposal

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements

Marketing Authorisation Number

Kesium 50 mg tablet Vm 15052/4132

Kesium 62.5 mg tablet Vm 15052/4134

Kesium 250 mg tablet: Vm 15052/4131

Kesium 500 mg tablet: Vm 15052/4133

Kesium 625mg tablet: Vm 15052/4135

Date of the first authorisation or date of renewal

Kesium 50 mg tablets: 5th October 2011

Kesium 62.5 mg tablets: 5th October 2011

Kesium 250 mg tablets: 5th October 2011

Kesium 500 mg tablets: 5th October 2011

Kesium 625mg tablets: 24th October 2013

Date of revision of the text

August 2016

Any other information

Legal category

Delivery Information

How quickly do you deliver?

Under almost all products on our website is an Estimated dispatch time, check this for a delivery prediction specific to the item you are looking to purchase. These badges are updated live based on the stock levels we have and also those of our suppliers - so are usually very accurate, but cannot be guaranteed. In more general terms, we aim to dispatch all orders within 1 working day of receiving payment (and a prescription if required). If we cannot do so within 3 working days we will contact you by email.

What do you charge for delivery?

For UK delivery, we charge the following:

Order Total Weight Delivery
£0-£28.99 Under 2kg £2.99
2kg+ £4.99
£29-£38.99 Under 2kg Free
2kg+ £4.99
£39+ Under 2kg Free
2kg+ Free

Prices quoted are for delivery to all parts of mainland UK except certain Scottish postcodes (where the price is higher for items sent by courier. Delivery of food abroad (including Channel Islands, N. Ireland and other islands around the UK) is charged at a higher price and free delivery is not available. Temperature controlled products, such as Insulin, are also not always subject to the standard and/or free delivery options.

For full information on our delivery charges, including prices on heavy deliveries to Scotland and abroad, see our delivery information page.

We can deliver most items to all around the world, but prices do vary. The majority of light weight orders (less than 1.5kg) can be delivered for a flat rate of £10. For an accurate estimate of the delivery charge, please put the items you require in your basket and use the "Estimate Delivery" system on the shopping basket page (you only need to enter your country and postal/zip code) for a quick quote. For deliveries to the USA you may need to go to the checkout page and enter your full address to get a quote (as some services need your state in order to quote too). For more information on international deliveries, please see our delivery information page.

Delivery of aerosols

Due to restrictions aerosols can't be sent by Royal Mail. We appreciate your understanding.

Delivery of temperature controlled items

Some products, such as insulin and frozen food, need to be delivered in insulated packaging to prevent them from getting too warm (or too cold) during transit from us to you. Purchasing any of these items in your order will result in a £1.99 charge being added to the total to cover the high cost of the insulated packaging materials. You only pay the £1.99 once per order, regardless of how many temperature controlled items you purchase in that order.

How do I cancel or return an order?

Please call us as soon as possible if you need to amend or cancel an order on 01582 842096. If your order has been processed for dispatch we will be unable to cancel or amend the order. You will however be able to return your product for a full refund*.

To return an item, you must contact us by phone or email to arrange this BEFORE posting any product back to us. We will explain the process at this stage for you.

*For full details on returns, see our terms and conditions page.

Reviews (2)

Q & A

There are currently no questions for Kesium Chewable Tablets for Dogs & Cats - be the first to ask one!