How do I buy prescription medication?

Clavubactin Tablets

Clavubactin Tablets
50/12.5mg Tablet » Priced per Tablet

  • 50/12.5mg Tablet » Priced per Tablet £0.49
  • 250/62.5mg Tablet » Priced per Tablet £1.00
  • 500/125mg Tablet » Priced per Tablet £1.90

Selection of 3 products from

£0.49 to £1.90

Description

The only potentiated amoxicillin in the UK that allows for optimum dosing across all 3 tablet strengths. The use of SmartTab technology increases accuracy still further with a 4-way tablet split for easy dosing, whatever the weight of the animal.

3. PHARMACEUTICAL FORM Tablets. Yellowish - white to light yellow round tablet with a cross - shaped break mark on one side. The tablets can be divided into 4 equal parts. 4. CLINICAL PARTICULARS 4.1 Target species Dogs and cats 4.2 Indications for use, specifying the target species Treatment of infections in cats and dogs caused by bacteria sensitive to amoxicillin in combination with clavulanic acid, part icularly: R evised: February 2016 AN: 01488/2014 Page 2 of 7 - Skin infections (including superficial and deep pyodermas) associated with Staphylococci (including beta - lactamase producing strains) and Streptococci. - Urinary tract infections associated with Staphylococci (including beta - lactamase producing str ains), Streptococci, Escherichia coli (including beta - lactamase producing strains), Fusobacterium necrophorum and Proteus spp . - Respiratory tract infections associated with Staphylococci (including beta - lactamase producing strains), Streptococci and Pasteurellae. - Gastrointestinal tract infections associated with Escherichia coli (including beta - lactamase producing strains) and Proteus spp. - Infections of the oral cavity (mucous membrane) associated with Clostridia, Corynebacteria, Staphylococci (includ ing beta - lactamase producing strains), Streptococci, Bacteroides spp (including beta - lactamase producing strains), Fusobacterium necrophorum and Pasteurellae. 4.3 Contraindications Do not use in animals with known hypersensitivity to penicillin or other substances of the beta - lactam group or any of the excipients. Do not use in serious dysfunction of the kidneys accompanied by anuria and oliguria. Do not use in rabbits, guinea pigs, hamsters, chinchillas and gerbils. Do not use in case of known resistance to the combination. 4.4 Special warnings for each target species None known. 4.5 Special precautions for use Special precautions for use in animals Official, national and regional antimicrobial policies should be taken into account when the product is used. 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 susceptib ility 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 β - lactam antibiotics due to the potential for cross - r esistance. In animals with hepatic and renal failure, the dosing regimen should be carefully evaluated. Caution is advised in the use in small herbivores other than those in the section 4.3. 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. R evised: February 2016 AN: 01488/2014 Page 3 of 7 Handle this product with great care to avoid exposure, t aking 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 4.6 Adverse reactions (frequency and seriousness) Mild gastrointestinal symptoms (diarrhoea, nausea and vomiting) may occur after administration of the product. Allergic reactions (skin reactions, anaphylaxia) may occasionally occur. In these cases, administration should be discontinued and a symptomatic treatment given. 4.7 Use during pregnancy, lactation or lay Laboratory studies in rats and mice have not produced any evidence of tera togenic or fetotoxic effects. No studies have been conducted in the pregnant and lactating dogs and cats. Use only according to the benefit/risk assessment by the responsible veterinarian. 4.8 Interaction with other medicinal products and other forms of i nteraction Chloramphenicol, macrolides, sulfonamides, and tetracyclines may inhibit the antibacterial effects of penicillins. The potential for allergic cross - reactivity with other penicillins should be considered. Penicillins may increase the effect of aminoglycosides. 4.9 Amounts to be administered and administration route Posology For oral administration in dogs and cats. To ensure a correct dosage body weight should be determined as accurately as possible to avoid underdosing. Dosage The recommended dose is 12.5 mg of combined active substance (=10 mg amoxicillin and 2.5 mg clavulanic acid) per kg bodyweight, twice daily. The following table is intended as a guide to dispensing the product at the standard dose rate of 12.5 mg of combined a ctives per kg bodyweight twice daily. Number of tablets twice daily Bodyweight (kg) amoxicilline 50 mg/ clavulanic acid 12.5 mg amoxicilline 250 mg/ clavulanic acid 62.5 mg amoxicilline 500 mg/ clavulanic acid 125 mg 1 – 1.25 1.25 – 2.5 R evised: February 2016 AN: 01488/2014 Page 4 of 7 2.5 – 3.75 3.75 – 5 5 – 6.25 6.25 - 12.5 12.5 - 18.75 18.75 - 25 25 - 31.25 31.25 - 37.5 37.5 - 50 50 – 62.5 62.5 - 75 In refractory cases of skin infections, a double dose is recommended (25 mg per kg bodyweight, twice daily). 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. 4.10 Overdose (symptoms, emergency procedures, antidotes) Mild gastrointestinal signs (diarrhea, nausea and vomiting) may occur more frequently after overdose of the product. 4.11 Withdrawal period(s) Not applicable. 5. PHARMACOLOGICAL PROPERTIES Pharmacotherapeutic group: Antibacterials for systemic use, amoxicillin and enzyme inhibitor. ATCvet code: QJ01CR02 5.1 Pharmacodynamic properties Amoxicillin is an aminobenzylpenicillin from the β - lactam penicillin family which prevents the bacterial cell wall formation by interfering with the final step of peptidoglycan synthesis. Clavulanic acid is an irreversible inhibitor of intracellular and extracellular β - lactamases which protects amoxicillin from inactivation by many β - lactamases. Amoxicillin/clavulanate has a wide range of activity which includes β - lactamase producing strains of both Gram - positive and Gram - negative aerobes, facultative ana erobes and obligate anaerobes. R evised: February 2016 AN: 01488/2014 Page 5 of 7 Good susceptibility is shown with several gram - positive bacteria including Staphylococci (including beta - lactamase producing strains, MIC90 0.5 μg/ml), Clostridia (MIC90 0.5 μg/ml), Corynebacteria and Streptococci, and gram - n egative bacteria including Bacteroides spp (including betalactamase producing strains, MIC90 0.5 μg/ml), Pasteurellae (MIC90 0.25 μg/ml), Escherichia coli (including beta - lactamase producing strains, MIC90 8 μg/ml) and Proteus spp (MIC90 0.5 μg/ml). Variable susceptibility is found in some E. coli . Susceptibility tests on bacterial pathogens from canine and feline origin revealed the following MIC50 values for a fixed combination of amoxicillin and clavulanic acid (2:1): Proteus spp 0.5 μg/ml and Staphylococcus intermedius 0.094 μg/ml. Bacteria with a MIC90 of < 2 μg/ml are considered being susceptible and those with a MIC90 of > 8 μg/ml being resistant. Resistance is shown among methicillin - resistant Staphylococcus aureus . A trend i n resistance of E. coli is reported. 5.2 Pharmacokinetic particulars The pharmacokinetic behaviour of clavulanic acid is roughly comparable with that of amoxicillin. Amoxicillin is well absorbed after oral administration. In dogs, the systemic bioavailab ility is 60 - 70%. Amoxicillin (pKa 2.8) has a relatively small apparent distribution volume, low plasma - protein binding (34% in dogs) and a short elimination half - life period due to active tubular excretion by the kidneys. After absorption, highest concentr ations are found in the kidneys (urine) and bile, followed by the liver, lungs, heart and spleen. Distribution of amoxicillin into cerebrospinal fluid is low unless the meninges are inflamed. Clavulanic acid (pKa 2.7) is also well absorbed after oral admin istration. Penetration into cerebrospinal fluid is poor. Plasma - protein binding is about 25% and the elimination half - life value is short. Clavulanic acid is largely eliminated by renal excretion (unchanged in the urine). The pharmacokinetic parameters of the veterinary medicinal product in dogs and cats after oral administration of a dose of 25 mg active material (= 20 mg amoxicillin + 5 mg clavulanic acid) per kg body weight are summarized in the following table. Cmax Tmax t1/2 AUC∞ (μg/ml) (hour) (hour) h.μg/ml Dog Amoxicillin 11.41 ± 2.74 1.38 ± 0.41 1.52 ± 0.19 36.57 ± 7.31 Clavulanic acid 2.06 ± 1.05 0.95 ± 0.33 0.71 ± 0.23 3.14 ± 1.21 Cat Amoxicillin 12.87 ± 2.12 1.47 ± 0.44 1.24 ± 0.28 38.74 ± 4.68 Clavulanic acid 4.60 ± 1.68 0.72 ± 0.26 0.63 ± 0.16 6.18 ± 2.19 6. PHARMACEUTICAL PARTICULARS 6.1 List of excipients Quinoline yellow lacquer (E104) Titanium dioxide (E171) Microcrystalline cellulose Hypromellose R evised: February 2016 AN: 01488/2014 Page 6 of 7 Crospovidone Povidone K - 25 Macrogol 6000 Stearic acid Saccharin sodium (E954) Vanilla flavour Colloidal anhydrous silica Magnesium stearate. 6.2 Incompatibilities Not applicable. 6.3 Shelf life Shelf - life of the veterinary medicinal product as packaged for sale: 2 years. Shelf - life of tablet quarters: 12 hours. 6. 4. Special precautions for storage Do not store above 25°C. Store in the original container. Quarter tablets should be returned to the opened strip and stored in a refrigerator. 6.5 Nature and composition of immediate packaging Carton containing 5 aluminium/aluminium blister strips each strip with 2 tablets corresponding to 10 tablets per carton. Carton containing 5 aluminium/aluminium blister strips each strip with 4 tablets corresponding to 20 tablets per carton. Carton containing 25 aluminium/aluminium blister strips each strip with 4 tablets corresponding to 100 tablets per carton. Carton containing 1 aluminium/aluminium blister strip with 10 tablets corresponding to 10 tablets per carton. Carton containing 10 al uminium/aluminium blister strips each strip with 10 tablets corresponding to 100 tablets per carton. Carton containing 25 aluminium/aluminium blister strips each strip with 10 tablets corresponding to 250 tablets per carton. Not all pack sizes may be marke ted. 6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products shoul d be disposed of in accordance with local requirements. R evised: February 2016 AN: 01488/2014 Page 7 of 7 7. MARKETING AUTHORISATION HOLDER Le Vet Beheer B.V. Wilgenweg 7 3421 TV Oudewater The Netherlands 8. MARKETING AUTHORISATION NUMBER Vm 19994/4028 9. DATE OF FIRST AUTHORISATION 11 October 2010 10. DATE OF REVISION OF THE TEXT February 2016 DISTRIBUTED BY Animalcare Ltd 10 Great North Way York Business Park Nether Poppleton York YO26 6RB

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

50/12.5mg Tablet » Priced per Tablet

SUMMARY OF PRODUCT CHARACTERISTICS

  1. NAME OF THE VETERINARY MEDICINAL PRODUCT

NL: Clavoral 50/12.5 mg tabletten voor katten en honden CZ: Clavubactin 50/12.5 mg tablety pro kočky a psi ES: Clavubactin 50/12.5 mg comprimidos para gatos y perros FR: Clavubactin 50/12.5 mg comprimés pour chats et chiens HU: Clavubactin 50/12.5 mg tabletta macskák és kutyák számára IE: Clavubactin 50/12.5 mg tablets for cats and dogs IS: Clavubactin vet. 50/12.5 mg töflur fyrir ketti og hunda IT: Clavubactin 50/12.5 mg compresse per gatti e cani PL: Clavubactin vet. 50/12.5 mg tabletki dla kotów i psów SK: Clavubactin 50/12.5 mg tablety pre psov a mačky UK: Clavubactin 50/12.5 mg tablets for cats and dogs

  1. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains:

Active substances: quantity Amoxicillin (as amoxicillin trihydrate) 50 mg Clavulanic acid (as potassium clavulanate) 12.5 mg

Excipient(s): Quinoline Yellow E104 0.06 mg Titanium dioxide E171 0.10 mg

For the full list of excipients, see section 6.1.

  1. PHARMACEUTICAL FORM

Tablets. Yellowish-white to light yellow round tablet with a cross-shaped break mark on one side. The tablets can be divided into 4 equal parts.

  1. CLINICAL PARTICULARS

4.1 Target species

Dogs and cats

4.2 Indications for use, specifying the target species

Treatment of infections in cats and dogs caused by bacteria sensitive to amoxicillin in combination with clavulanic acid, particularly: Skin infections (including superficial and deep pyodermas) associated with Staphylococci (including beta-lactamase producing strains) and Streptococci. Urinary tract infections associated with Staphylococci (including beta-lactamase producing strains), Streptococci, Escherichia coli (including beta-lactamase producing strains), Fusobacterium necrophorum and Proteus spp. Respiratory tract infections associated with Staphylococci (including beta-lactamase producing strains), Streptococci and Pasteurellae. Gastrointestinal tract infections associated with Escherichia coli (including beta-lactamase producing strains) and Proteus spp. Infections of the oral cavity (mucous membrane) associated with Clostridia, Corynebacteria, Staphylococci (including beta-lactamase producing strains), Streptococci, Bacteroides spp (including beta-lactamase producing strains), Fusobacterium necrophorum and Pasteurellae.

4.3 Contraindications

Do not use in animals with known hypersensitivity to penicillin or other substances of the beta-lactam group or any of the excipients. Do not use in serious dysfunction of the kidneys accompanied by anuria and oliguria. Do not use in rabbits, guinea pigs, hamsters, chinchillas and gerbils. Do not use in case of known resistance to the combination.

4.4 Special warnings for each target species

None known.

4.5 Special precautions for use

Special precautions for use in animals Official, national and regional antimicrobial policies should be taken into account when the product is used. 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 β-lactam antibiotics due to the potential for cross-resistance. In animals with hepatic and renal failure, the dosing regimen should be carefully evaluated. Caution is advised in the use in small herbivores other than those in the section 4.3.

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

4.6 Adverse reactions (frequency and seriousness)

Mild gastrointestinal symptoms (diarrhoea, nausea and vomiting) may occur after administration of the product. Allergic reactions (skin reactions, anaphylaxia) may occasionally occur. In these cases, administration should be discontinued and a symptomatic treatment given.

4.7 Use during pregnancy, lactation or lay

Laboratory studies in rats and mice have not produced any evidence of teratogenic or fetotoxic effects. No studies have been conducted in the pregnant and lactating dogs and cats. Use only according to the benefit/risk assessment by the responsible veterinarian.

4.8 Interaction with other medicinal products and other forms of interaction

Chloramphenicol, macrolides, sulfonamides, and tetracyclines may inhibit the antibacterial effects of penicillins. The potential for allergic cross-reactivity with other penicillins should be considered. Penicillins may increase the effect of aminoglycosides.

4.9 Amounts to be administered and administration route

Posology For oral administration in dogs and cats. To ensure a correct dosage body weight should be determined as accurately as possible to avoid underdosing.

Dosage The recommended dose is 12.5 mg of combined active substance (=10 mg amoxicillin and 2.5 mg clavulanic acid) per kg bodyweight, twice daily. The following table is intended as a guide to dispensing the product at the standard dose rate of 12.5 mg of combined actives per kg bodyweight twice daily.

Number of tablets twice daily

Bodyweight (kg) amoxicilline 50 mg/ clavulanic acid 12.5 mg amoxicilline 250 mg/ clavulanic acid 62.5 mg amoxicilline 500 mg/ clavulanic acid 125 mg 1 – 1.25
1.25 – 2.5
2.5 – 3.75
3.75 – 5
5 – 6.25
6.25 - 12.5
12.5 - 18.75
18.75 - 25
25 - 31.25
31.25 - 37.5
37.5 - 50
50 – 62.5
62.5 - 75

In refractory cases of skin infections, a double dose is recommended (25 mg per kg bodyweight, twice daily).

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.

4.10 Overdose (symptoms, emergency procedures, antidotes)

Mild gastrointestinal signs (diarrhea, nausea and vomiting) may occur more frequently after overdose of the product.

4.11 Withdrawal period(s)

Not applicable.

  1. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Antibacterials for systemic use, amoxicillin and enzyme inhibitor. ATCvet code: QJ01CR02

5.1 Pharmacodynamic properties

Amoxicillin is an aminobenzylpenicillin from the β-lactam penicillin family which prevents the bacterial cell wall formation by interfering with the final step of peptidoglycan synthesis. Clavulanic acid is an irreversible inhibitor of intracellular and extracellular β-lactamases which protects amoxicillin from inactivation by many β-lactamases. Amoxicillin/clavulanate has a wide range of activity which includes β‑lactamase producing strains of both Gram-positive and Gram-negative aerobes, facultative anaerobes and obligate anaerobes. Good susceptibility is shown with several gram-positive bacteria including Staphylococci (including beta-lactamase producing strains, MIC90 0.5 μg/ml), Clostridia (MIC90 0.5 μg/ml), Corynebacteria and Streptococci, and gram-negative bacteria including Bacteroides spp (including betalactamase producing strains, MIC90 0.5 μg/ml), Pasteurellae (MIC90 0.25 μg/ml), Escherichia coli (including beta-lactamase producing strains, MIC90 8 μg/ml) and Proteus spp (MIC90 0.5 μg/ml). Variable susceptibility is found in some E. coli. Susceptibility tests on bacterial pathogens from canine and feline origin revealed the following MIC50 values for a fixed combination of amoxicillin and clavulanic acid (2:1): Proteus spp 0.5 µg/ml and Staphylococcus intermedius 0.094 µg/ml. Bacteria with a MIC90 of < 2 µg/ml are considered being susceptible and those with a MIC90 of > 8 µg/ml being resistant. Resistance is shown among methicillin-resistant Staphylococcus aureus. A trend in resistance of E. coli is reported.

5.2 Pharmacokinetic particulars

The pharmacokinetic behaviour of clavulanic acid is roughly comparable with that of amoxicillin. Amoxicillin is well absorbed after oral administration. In dogs, the systemic bioavailability is 60-70%. Amoxicillin (pKa 2.8) has a relatively small apparent distribution volume, low plasma-protein binding (34% in dogs) and a short elimination half-life period due to active tubular excretion by the kidneys. After absorption, highest concentrations are found in the kidneys (urine) and bile, followed by the liver, lungs, heart and spleen. Distribution of amoxicillin into cerebrospinal fluid is low unless the meninges are inflamed. Clavulanic acid (pKa 2.7) is also well absorbed after oral administration. Penetration into cerebrospinal fluid is poor. Plasma-protein binding is about 25% and the elimination half-life value is short. Clavulanic acid is largely eliminated by renal excretion (unchanged in the urine). The pharmacokinetic parameters of the veterinary medicinal product in dogs and cats after oral administration of a dose of 25 mg active material (= 20 mg amoxicillin + 5 mg clavulanic acid) per kg body weight are summarized in the following table.

Cmax    Tmax    t1/2    AUC∞
(µg/ml)    (hour)    (hour)    h.µg/ml

Dog
Amoxicillin 11.41 ± 2.74 1.38 ± 0.41 1.52 ± 0.19 36.57 ± 7.31 Clavulanic acid 2.06 ± 1.05 0.95 ± 0.33 0.71 ± 0.23 3.14 ± 1.21 Cat
Amoxicillin 12.87 ± 2.12 1.47 ± 0.44 1.24 ± 0.28 38.74 ± 4.68 Clavulanic acid 4.60 ± 1.68 0.72 ± 0.26 0.63 ± 0.16 6.18 ± 2.19

  1. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Quinoline yellow lacquer (E104) Titanium dioxide (E171) Microcrystalline cellulose Hypromellose Crospovidone Povidone K-25 Macrogol 6000 Stearic acid Saccharin sodium (E954) Vanilla flavour Colloidal anhydrous silica Magnesium stearate.

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

Shelf-life of the veterinary medicinal product as packaged for sale: 2 years. Shelf-life of tablet quarters: 12 hours.

6.4. Special precautions for storage

Do not store above 25°C. Store in the original container. Quarter tablets should be returned to the opened strip and stored in a refrigerator.

6.5 Nature and composition of immediate packaging

Carton containing 5 aluminium/aluminium blister strips each strip with 2 tablets corresponding to 10 tablets per carton. Carton containing 5 aluminium/aluminium blister strips each strip with 4 tablets corresponding to 20 tablets per carton. Carton containing 25 aluminium/aluminium blister strips each strip with 4 tablets corresponding to 100 tablets per carton. Carton containing 1 aluminium/aluminium blister strip with 10 tablets corresponding to 10 tablets per carton. Carton containing 10 aluminium/aluminium blister strips each strip with 10 tablets corresponding to 100 tablets per carton. Carton containing 25 aluminium/aluminium blister strips each strip with 10 tablets corresponding to 250 tablets per carton. Not all pack sizes may be marketed.

6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products

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

  1. MARKETING AUTHORISATION HOLDER

Le Vet Beheer B.V. Wilgenweg 7 3421 TV Oudewater The Netherlands

  1. MARKETING AUTHORISATION NUMBER

Vm 19994/4028

  1. DATE OF FIRST AUTHORISATION

11 October 2010

  1. DATE OF REVISION OF THE TEXT

February 2016

23 February 2016

250/62.5mg Tablet » Priced per Tablet

SUMMARY OF PRODUCT CHARACTERISTICS

  1. NAME OF THE VETERINARY MEDICINAL PRODUCT

NL: Clavoral 250/62.5 mg tabletten voor honden CZ: Clavubactin 250/62.5 mg tablety pro psi ES: Clavubactin 250/62.5 mg comprimidos para perros FR: Clavubactin 250/62.5 mg comprimés pour chiens HU: Clavubactin 250/62.5 mg tabletta kutyák számára IE: Clavubactin 250/62.5 mg tablets for dogs IS: Clavubactin vet. 250/62.5 mg töflur fyrir hunda IT: Clavubactin 250/62.5 mg compresse per cani PL: Clavubactin vet. 250/62.5 mg tabletki dla psów SK: Clavubactin 250/62.5 mg tablety pre psov UK: Clavubactin 250/62.5 mg tablets for dogs

  1. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains:

Active substances: quantity Amoxicillin (as amoxicillin trihydrate) 250 mg Clavulanic acid (as potassium clavulanate) 62.5 mg

Excipient(s): Quinoline Yellow E104 0.3 mg Titanium dioxide E171 0.5 mg

For the full list of excipients, see section 6.1.

  1. PHARMACEUTICAL FORM

Tablets Yellowish-white to light yellow round tablet with a cross shaped break mark on one side. The tablets can be divided into four equal parts.

  1. CLINICAL PARTICULARS

4.1 Target species

Dogs

4.2 Indications for use, specifying the target species

Treatment of infections in dogs caused by bacteria sensitive to amoxicillin in combination with clavulanic acid, particularly: Skin infections (including superficial and deep pyodermas) associated with Staphylococci (including beta-lactamase producing strains) and Streptococci. Urinary tract infections associated with Staphylococci (including beta-lactamase producing strains), Streptococci, Escherichia coli (including beta-lactamase producing strains), Fusobacterium necrophorum and Proteus spp. Respiratory tract infections associated with Staphylococci (including beta-lactamase producing strains), Streptococci and Pasteurellae. Gastrointestinal tract infections associated with Escherichia coli (including beta-lactamase producing strains) and Proteus spp. Infections of the oral cavity (mucous membrane) associated with Clostridia, Corynebacteria, Staphylococci (including beta-lactamase producing strains), Streptococci, Bacteroides spp (including beta-lactamase producing strains), Fusobacterium necrophorum and Pasteurellae.

4.3 Contraindications

Do not use in animals with known hypersensitivity to penicillin or other substances of the beta-lactam group or any of the excipients. Do not use in serious dysfunction of the kidneys accompanied by anuria and oliguria. Do not use in rabbits, guinea pigs, hamsters, chinchillas and gerbils. Do not use in case of known resistance to the combination.

4.4 Special warnings for each target species

None known.

4.5 Special precautions for use

Special precautions for use in animals Official, national and regional antimicrobial policies should be taken into account when the product is used. 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 β-lactam antibiotics due to the potential for cross-resistance. In animals with hepatic and renal failure, the dosing regimen should be carefully evaluated. Caution is advised in the use in small herbivores other than those in the section 4.3.

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.

4.6 Adverse reactions (frequency and seriousness)

Mild gastrointestinal symptoms (diarrhoea, nausea and vomiting) may occur after administration of the product. Allergic reactions (skin reactions, anaphylaxia) may occasionally occur. In these cases, administration should be discontinued and a symptomatic treatment given.

4.7 Use during pregnancy, lactation or lay

Laboratory studies in rats and mice have not produced any evidence of teratogenic or fetotoxic effects. No studies have been conducted in the pregnant and lactating dogs. Use only according to the benefit/risk assessment by the responsible veterinarian.

4.8 Interaction with other medicinal products and other forms of interaction

Chloramphenicol, macrolides, sulfonamides, and tetracyclines may inhibit the antibacterial effects of penicillins. The potential for allergic cross-reactivity with other penicillins should be considered. Penicillins may increase the effect of aminoglycosides.

4.9 Amounts to be administered and administration route

Posology For oral administration in dogs. To ensure a correct dosage body weight should be determined as accurately as possible to avoid underdosing.

Dosage The recommended dose is 12.5 mg of combined active substance (=10 mg amoxicillin and 2.5 mg clavulanic acid) per kg bodyweight, twice daily. The following table is intended as a guide to dispensing the product at the standard dose rate of 12.5 mg of combined actives per kg bodyweight twice daily.

Number of tablets twice daily

Bodyweight (kg) amoxicilline 50 mg/ clavulanic acid 12.5 mg amoxicilline 250 mg/ clavulanic acid 62.5 mg amoxicilline 500 mg/ clavulanic acid 125 mg 1 – 1.25
1.25 – 2.5
2.5 – 3.75
3.75 – 5
5 – 6.25
6.25 - 12.5
12.5 - 18.75
18.75 - 25
25 - 31.25
31.25 - 37.5
37.5 - 50
50 – 62.5
62.5 - 75

In refractory cases of skin infections, a double dose is recommended (25 mg per kg bodyweight, twice daily).

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.

4.10 Overdose (symptoms, emergency procedures, antidotes)

Mild gastrointestinal symptoms (diarrhea, nausea and vomiting) may occur more frequently after overdose of the product.

4.11 Withdrawal period(s)

Not applicable.

  1. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Antibacterials for systemic use, amoxicillin and enzyme inhibitor. ATCvet code: QJ01CR02

5.1 Pharmacodynamic properties

Amoxicillin is an aminobenzylpenicillin from the β-lactam penicillin family which prevents the bacterial cell wall formation by interfering with the final step of peptidoglycan synthesis. Clavulanic acid is an irreversible inhibitor of intracellular and extracellular β-lactamases which protects amoxicillin from inactivation by many β-lactamases. Amoxicillin/clavulanate has a wide range of activity which includes β‑lactamase producing strains of both Gram-positive and Gram-negative aerobes, facultative anaerobes and obligate anaerobes. Good susceptibility is shown with several gram-positive bacteria including Staphylococci (including beta-lactamase producing strains, MIC90 0.5 μg/ml), Clostridia (MIC90 0.5 μg/ml), Corynebacteria and Streptococci, and gram-negative bacteria including Bacteroides spp (including betalactamase producing strains, MIC90 0.5 μg/ml), Pasteurellae (MIC90 0.25 μg/ml), Escherichia coli (including beta-lactamase producing strains, MIC90 8 μg/ml) and Proteus spp (MIC90 0.5 μg/ml). Variable susceptibility is found in some E. coli. Susceptibility tests on bacterial pathogens from canine and feline origin revealed the following MIC50 values for a fixed combination of amoxicillin and clavulanic acid (2:1): Proteus spp 0.5µg/ml and Staphylococcus intermedius 0.094 µg/ml. Bacteria with a MIC90 of < 2 µg/ml are considered being susceptible and those with a MIC90 of > 8 µg/ml being resistant. Resistance is shown among methicillin-resistant Staphylococcus aureus. A trend in resistance of E. coli is reported.

5.2 Pharmacokinetic particulars

The pharmacokinetic behaviour of clavulanic acid is roughly comparable with that of amoxicillin. Amoxicillin is well absorbed after oral administration. In dogs, the systemic bioavailability is 60-70%. Amoxicillin (pKa 2.8) has a relatively small apparent distribution volume, low plasma-protein binding (34% in dogs) and a short elimination half-life period due to active tubular excretion by the kidneys. After absorption, highest concentrations are found in the kidneys (urine) and bile, followed by the liver, lungs, heart and spleen. Distribution of amoxicillin into cerebrospinal fluid is low unless the meninges are inflamed. Clavulanic acid (pKa 2.7) is also well absorbed after oral administration. Penetration into cerebrospinal fluid is poor. Plasma-protein binding is about 25% and the elimination halflife value is short. Clavulanic acid is largely eliminated by renal excretion (unchanged in the urine). The pharmacokinetic parameters of the veterinary medicinal product in dogs after oral administration of a dose of 25 mg active material (= 20 mg amoxicillin + 5 mg clavulanic acid) per kg body weight are summarized in the following table.

Cmax    tmax    t1/2    AUC∞
(µg/ml)    (hour)    (hour)    h.µg/ml

Amoxicillin 11.41 ± 2.74 1.38 ± 0.41 1.52 ± 0.19 36.57 ± 7.31 Clavulanic acid 2.06 ± 1.05 0.95 ± 0.33 0.71 ± 0.23 3.14 ± 1.21

  1. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Quinoline yellow lacquer (E104) Titanium dioxide (E171) Microcrystalline cellulose Hypromellose Crospovidone Povidone K-25 Macrogol 6000 Stearic acid Saccharin sodium (E954) Vanilla flavour Colloidal anhydrous silica Magnesium stearate.

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

Shelf-life of the veterinary medicinal product as packaged for sale: 3 years. Shelf-life of tablet quarters: 12 hours.

6.4. Special precautions for storage

Do not store above 25°C. Store in the original container. Quarter tablets should be returned to the opened strip and stored in a refrigerator.

6.5 Nature and composition of immediate packaging

Carton containing 5 aluminium/aluminium blister strips each strip with 2 tablets corresponding to 10 tablets per carton. Carton containing 5 aluminium/aluminium blister strips each strip with 4 tablets corresponding to 20 tablets per carton. Carton containing 25 aluminium/aluminium blister strips each strip with 4 tablets corresponding to 100 tablets per carton. Carton containing 1 aluminium/aluminium blister strip with 10 tablets corresponding to 10 tablets per carton. Carton containing 10 aluminium/aluminium blister strips each strip with 10 tablets corresponding to 100 tablets per carton. Carton containing 25 aluminium/aluminium blister strips each strip with 10 tablets corresponding to 250 tablets per carton. Not all pack sizes may be marketed.

6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products

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

  1. MARKETING AUTHORISATION HOLDER

Le Vet B.V. Wilgenweg 7 3421 TV Oudewater The Netherlands

MARKETING AUTHORISATION NUMBER

Vm 19994/4026

DATE OF FIRST AUTHORISATION

11 October 2010

DATE OF REVISION OF THE TEXT

February 2017

Approved 20 February 2017

500/125mg Tablet » Priced per Tablet

Clavaseptin 50 mg and 62.5 mg Palatable Tablets for Dogs and Cats, Clavaseptin 250 mg and 500 mg Palatable Tablets for Dogs: 2016-03-31 14:15

Presentation

Four tablet strengths are available: Clavaseptin 50 mg Palatable Tablets containing 40mg amoxicillin (as trihydrate) and 10mg clavulanic acid (as potassium salt). For use in cats and dogs.

Clavaseptin 62.5 mg Palatable Tablets containing 50 mg amoxicillin (as trihydrate) and 12.5 mg clavulanic acid (as potassium salt). For use in cats and dogs.

Clavaseptin 250 mg Palatable Tablets containing 200 mg amoxicillin (as trihydrate) and 50mg clavulanic acid (as potassium salt). For use in dogs.

Clavaseptin 500 mg Palatable Tablets containing 400mg amoxicillin (as trihydrate) and 100mg clavulanic acid (as potassium salt). For use in dogs.

Excipient: Brown Iron Oxide (E172)

Uses

In dogs: treatment or adjunctive treatment of periodontal infections caused by bacteria susceptible to amoxicillin in combination with clavulanic acid i.e. Pasteurella spp, Streptococcus spp and Escherichia coli.

In cats: treatment of skin infections (including wounds and abscesses) caused by bacteria susceptible to amoxicillin in combination with clavulanic acid i.e. Pasteurella spp, Staphylococcus spp, Streptococcus spp and Escherichia coli.

Dosage and administration

For oral administration.

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

The recommended dose of Clavaseptin Palatable Tablets is 10 mg amoxicillin/2.5mg clavulanic acid/kg twice daily by the oral route in dogs and cats.

In severe infections, the dose may be doubled to 20 mg amoxicillin/5 mg clavulanic acid/kg body weight twice daily.

Duration of treatment:

- 7 days for the treatment of periodontal infections in dogs

- 7 to 14 days for the treatment of skin infections in cats (including wounds and abscesses). The clinical status of animals should be re-evaluated after 7 days and the treatment prolonged for a further 7 days if necessary.

Administration is made easier by the palatable nature of the tablet.

Contra-indications, warnings, etc

Do not use in case of hypersensitivity to penicillins or other substances of the β-lactam group or to any of the excipients.

Do not administer to gerbils, guinea pigs, hamsters, rabbits and chinchillas.

Do not administer to horses and ruminating animals.

Do not use in animals with serious dysfunction of the kidneys accompanied by anuria or oliguaria.

Do not use in cases of known resistance to the combination of amoxicillin and clavulanic acid.

Special precautions for use in animals

In animals with impaired liver and kidney function, the use of the product should be subject to a risk/benefit evaluation by the veterinary surgeon and the posology evaluated carefully.

Caution is advised in the use of Clavaseptin in any other small pet (non food-producing) herbivores.

Use of the product should be based on susceptibility testing.

Inappropriate use of the product may increase the prevalence of bacteria resistant to amoxicillin/clavulanic acid and may decrease the effectiveness of treatment with other beta lactam antibiotics, due to the potential for cross resistance. Use of the product should take into account official and local antimicrobial policies. Do not use in cases of bacteria sensitive to narrow spectrum penicillins or to amoxicillin as a single substance.

Adverse reactions (frequency and seriousness)

Vomiting and diarrhoea may be observed. Treatment may be continued depending on the severity of the undesirable effect observed and a benefit/risk evaluation by the veterinary surgeon.

Hypersensitivity reactions (allergic skin reactions, anaphylaxis) may be observed. In these cases, administration should be discontinued and a symptomatic treatment given.

Use during pregnancy and lactation

The safety of the product has not been established during pregnancy and lactation. Laboratory studies in rats have not produced any evidence of teratogenic, foetotoxic or maternotoxic effects. Use the product only accordingly to the benefit/risk assessment by the responsible veterinarian.

Interaction with other medicinal products and other forms of interaction

The bactericidal activity of amoxicillin may be reduced by the simultaneous use of bacteriostatic substances such as macrolides, tetracyclines, sulfonamides and chloramphenicol. The potential for allergic cross-reactivity with other pencillins should be considered. Penicillins may increase the effect of aminoglycosides.

Overdose (symptoms, emergency procedures, antidotes), if necessary

At three times the recommended dose for a period of 28 days, a decrease in cholesterol values and episodes of vomiting were observed in cats and diarrhoea was observed in dogs. In the event of an overdose, symptomatic treatment is advised.

Operator warning

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.

1. Do not handle this product if you know you are sensitised, or if you have been advised not to work with such preparations.

2. Handle this product with great care to avoid exposure, taking all recommended precautions.

3. If you develop symptoms following exposure, such as skin rash, you should seek medical advice and show the doctor this warning. Swelling of the face, lips or eyes or difficulty in breathing are more serious symptoms and require urgent medical attention.

Wash hands after handling the tablets

Pharmaceutical precautions

Do not store above 25°C. Store in the original package.

Return any halved tablet to the opened strip-pack and use within 16 hours.

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

Legal category

Packaging quantities

Clavaseptin 50 mg Palatable Tablets: 10 and 50 blisters of 10 tablets

Clavaseptin 62.5 mg Palatable Tablets: 10 and 25 blisters of 10 tablets

Clavaseptin 250 mg Palatable Tablets: 10 and 25 blisters of 10 tablets

Clavaseptin 500 mg Palatable Tablets: 10 blisters of 10 tablets.

Further information

Amoxicillin is an aminobenzylpenicillin from the β-lactam penicillin family which prevents the bacterial cell wall formation by interfering with the final step of peptidoglycan synthesis.

Clavulanic acid is an irreversible inhibitor of intracellular and extracellular β-lactamases which protects amoxicillin from inactivation by many β-lactamases.

Amoxicillin/clavulanate has a wide range of activity which includes β‑lactamase producing strains of both Gram-positive and Gram-negative aerobes, facultative anaerobes and obligate anaerobes.

Resistance to β-lactam antibiotics is mainly mediated by β-lactamases which hydrolyze antibiotics such as amoxicillin.

After oral administration at the recommended dose in dogs and cats, the absorption of amoxicillin and clavulanic acid is fast. In dogs, the maximum plasma concentration of amoxicillin of 8.5 µg/ml is reached in 1.4 h and the maximum plasma concentration of clavulanic acid of 0.9 µg/ml is reached in 0.9h.

In cats, the maximum plasma concentration of amoxicillin of 6.6 µg/ml is reached in 1.8 h and the maximum plasma concentration of clavulanic acid of 3.7 µg/ml is reached in 0.75h. Elimination is also fast.

Half-life is 1 hour in dogs and 1-2 hours in cats for both substances.

After repeated oral administration of the recommended dose in dogs and cats, there is no accumulation of amoxicillin or clavulanic acid and the steady state is reached rapidly after first administration.

Refer to individual SPCs for further information.

Marketing Authorisation Number

Clavaseptin 50 mg Palatable Tablets: Vm 08007/4113

Clavaseptin 62.5 mg Palatable Tablets: Vm 08007/4135

Clavaseptin 250 mg Palatable Tablets: Vm 08007/4114

Clavaseptin 500 mg Palatable Tablets: Vm 08007/4115

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 (3)

Q & A

There are currently no questions for Clavubactin Tablets - be the first to ask one!