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Noroclav Tablets

Noroclav Tablets
50mg » Priced per Tablet

  • 50mg » Priced per Tablet £0.59
  • 250mg » Priced per Tablet £1.19
  • 500mg » Priced per Tablet £2.20
  • Chewable » 50mg » Priced per Tablet £0.49
  • Chewable » 250mg » Priced per Tablet £1.09

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Description

Noroclav Tablets are for use in cats and dogs for the treatment of bacterial infections affecting the respiratory, alimentary and urinary systems and the skin. They can also be used for other soft tissue infections and infected wounds. Noroclav Tablets contain amoxycillin and clavulanic acid which combine together to kill a broad spectrum of different types of bacteria. They are given twice daily by mouth for 5 days or longer as indicted by the type of infection.

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Medication Datasheets

50mg » Priced per Tablet

Noroclav 50 mg Tablets for Dogs and Cats

Qualitative and quantitative composition

Each tablet contains:Active substance(s): Amoxicillin (as amoxicillin trihydrate) 40 mgClavulanic acid (as Potassium Clavulanate)10 mgExcipients:Carmoisine Lake (E122)0.245 mgFor a full list of excipients, see section Pharmaceutical Particulars

Active substance(s):

Amoxicillin (as amoxicillin trihydrate)

40 mg

Clavulanic acid (as Potassium Clavulanate)

10 mg

Excipients:

Carmoisine Lake (E122)

0.245 mg

For a full list of excipients, see section Pharmaceutical Particulars

Pharmaceutical form

Tablet.

Round pink biconvex tablet with a score line and 50 embossed on opposing faces.

Clinical particulars

Target Species

Dogs and cats.

Indications for Use, Specifying the Target Species

Treatment of the following infections caused by b lactamase producing strains of bacteria sensitive to amoxicillin in combination with clavulanic acid:

It is recommended to carry out suitable tests for sensitivity testing when initiating the treatment. The treatment should only proceed if sensitivity is proven to the combination.

Contraindications

Do not use in animals with known hypersensitivity to penicillin or other substances of the beta-lactam group.

Do not use in rabbits, guinea pigs, hamsters or gerbils.

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

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

Do not administer to horses and ruminating animals.

Special Warnings for Each Target Species

None.

Special Precautions for Use

Special precautions for use in animals

Inappropriate use of the product may increase the prevalence of bacteria resistant to amoxicillin/clavulanic acid.

In animals with hepatic and renal failure, the dosing regimen should be carefully evaluated.

Use of the product should be based on susceptibility testing and take into account official and local antimicrobial policies. Narrow spectrum antibacterial therapy should be used for first line treatment where susceptibility testing suggests likely efficacy of this approach.

Caution is advised in the use in small herbivores other than those in section, Contraindications.

Dogs and cats diagnosed with Pseudomonas infections should not be treated with this antibiotic combination.

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 (Frequency and Seriousness)

Hypersensitivity reactions unrelated to dose can occur with these agents.

Gastrointestinal symptoms (diarrhoea, vomiting) may occur after administration of the product.

Allergic reactions (e.g. skin reactions, anaphylaxia) may occasionally occur.

In case of occurrence of allergic reaction, the treatment should be withdrawn.

Use During Pregnancy, Lactation or Lay

Studies in laboratory animals have not produced any evidence of teratogenic effects.

Use only according to the benefit/risk assessment by the responsible veterinarian.

Interaction with other Medicinal Products and Other Forms of Interaction

Chloramphenicol, macrolides, sulfonamides and tetracyclines may inhibit the antibacterial effect of penicillins because of the rapid onset of bacteriostatic action. The potential for allergic cross-reactivity with other penicillins should be considered.

Penicillins may increase the effect of aminoglycosides.

Amounts to be Administered and Administration

Administration is via the oral route. The dosage rate is 12.5 mg combined actives/kg bodyweight twice daily. The tablets may be crushed and added to a little food.

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 twice daily.BodyweightNumber of tablets twice daily1-2½3-415-61,57-829-102,511-12313-143,515-16417-184,5

Bodyweight

Number of tablets twice daily

1-2

½

3-4

1

5-6

1,5

7-8

2

9-10

2,5

11-12

3

13-14

3,5

15-16

4

17-18

4,5

Duration of therapy

Acute cases: 5 to 7 days of treatment.

If no improvement is observed after 5 to 7 days, the diagnosis should be re-assessed.

Chronic or refractory cases: In these cases where there is considerable tissue damage, a longer course of therapy may be required so that it allows sufficient time for damaged tissue to repair.

If no improvement is observed after two weeks, the diagnosis should be re-assessed.

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

The product is of a low order of toxicity and is well tolerated by the oral route.

In a tolerance study in dogs a tested dose of 3 times the recommended dose of 12.5mg of the combined actives administered twice daily for 8 days did not demonstrate adverse effects.

In a tolerance study in cats a tested dose of 3 times the recommended dose of 12.5mg of the combined actives administered twice daily for 15 days did not demonstrate adverse effects.

Withdrawal Period(s)

Not applicable.

Pharmacological particulars

Pharmacotherapeutic group: Beta-lactam antibacterials, penicillins

ATCvet code: QJ01CR02

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

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

Gram-positive:

Gram-negative:

Resistance is shown among Enterobacter spp, Pseudomonas aeruginosa and methicillin-resistant Staphylococcus aureus. A trend in resistance of E. coli is reported.

Pharmacokinetic properties

Amoxicillin is well-absorbed following oral administration. In dogs the systemic bioavailability is 60-70%. 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 (pK1 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 heavily eliminated by renal excretion (unchanged in urine).

After oral administration of the recommended dose of 12.5mg combined actives/kg to dogs, the following parameters were observed: Cmax of 6.30 +/-0.45µg/ml, Tmax of 1.98 +/- 0.135h and AUC of 23.38 +/- 1.39 µg/ml.h for amoxicillin and Cmax of 0.87 +/- 0.1µg/ml, Tmax of 1.57 +/- 0.177hrs and AUC of 1.56 +/- 0.24mg/ml.h for clavulanic acid.

After oral administration of the recommended dose of 12.5mg combined actives/kg to cats, the following parameters were observed: Cmax of 7.12 +/-1.460 µg/ml, Tmax of 2.69 +/- 0.561 h and AUC of 33.54 +/- 7.335 µg/ml.h for amoxicillin and Cmax of 1.67 +/- 0.381 µg/ml, Tmax of 1.83 +/- 0.227 h and AUC of 7.03 +/- 1.493 µg/ml.h for clavulanic acid.

Pharmaceutical particulars

List of Excipient(s)

Carmosine Lake (E122)

Sodium Starch Glycollate

Copovidone K24-36

Magnesium Stearate

Microcrystalline Cellulose

Calcium Carbonate

Heavy Magnesium carbonate

Roast Beef Flav-o-lok

Incompatibilities

Not applicable.

Shelf-Life

Shelf-life of the veterinary medicinal product as packaged for sale:

2 years (blister packs), 6 months (tubs).

Special Precautions for Storage

Do not store above 25°C. Store in the original package in order to protect from moisture.

Nature and Composition of Immediate Packaging

The product is supplied in high-density polyethylene tubs with a polypropylene screw cap lid containing 100 tablets and in high-density polyethylene tubs with a polyethylene screw cap lid containing 500 tablets. A sachet of desiccant is included in each container. The product is also presented in packs containing 2, 10 and 50 blister strips (aluminium-aluminium) each containing 10 tablets per strip.

Not all pack sizes may be marketed.

Special Precautions for the Disposal of Unused Veterinary Medicinal Products or Waste Materials Derived From the Use of Such Products, if appropriate

Any unused product or waste material should be disposed of in accordance with national requirements.

Marketing Authorisation Holder (if different from distributor)

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry

Co. Down

BT35 6JP

Northern Ireland

Marketing Authorisation Number

Vm 02000/4211

Date of the first authorisation or date of renewal

25th February 2009

Date of revision of the text

November 2011

Any other information

Nil.

Legal category

250mg » Priced per Tablet

Noroclav 250 mg Chewable Flavoured Tablets for Cats and Dogs

Qualitative and quantitative composition

Each tablet contains: Active substance(s): Amoxicillin (as amoxicillin trihydrate) 200 mgClavulanic acid (as Potassium Clavulanate)50 mgExcipients:For a full list of excipients, see section Pharmaceutical Particulars

Active substance(s):

Amoxicillin (as amoxicillin trihydrate)

200 mg

Clavulanic acid (as Potassium Clavulanate)

50 mg

Excipients:

For a full list of excipients, see section Pharmaceutical Particulars

Pharmaceutical form

Chewable Tablet.

Pale brown circular tablet with two crossing score lines and embossed with ‘250’ on opposing faces.

The tablets can be divided into equal halves.

Clinical particulars

Target Species

Cats and Dogs.

Indications for Use, Specifying the Target Species

Treatment of the following infections caused by beta-lactamase producing strains of bacteria sensitive to amoxicillin in combination with clavulanic acid:

It is recommended to carry out suitable tests for sensitivity when initiating the treatment. The treatment should only proceed if sensitivity is proven to the combination.

Contraindications

The product should not be given to rabbits, hamsters, guinea pigs or gerbils. Do not use in animals with known hypersensitivity to penicillin, other beta-lactams or any of the excipients.Do not use in animals with serious dysfunction of the kidneys accompanied by anuria or oliguria.

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

Do not administer to horses and ruminating animals.

Special Warnings for Each Target Species

None known.

Special Precautions for Use

Special precautions for use in animals

Whenever possible, the product should only be used based on susceptibility testing.

Use of the product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to beta-lactam antimicrobials and may decrease the effectiveness of treatment with other classes of antimicrobials due to the potential for cross resistance.

Official and regional antimicrobial policies should be taken into account.

In animals with hepatic and renal failure, the dosing regimen should be carefully evaluated.

Caution is advised in their use in small herbivores.

The chewable tablets are flavoured. In order to avoid any accidental ingestion, store tablets out of reach of animals.

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 (Frequency and Seriousness)

Hypersensitivity reactions to penicillins may occur in treated animals.

Allergic reactions (e.g. skin reactions, anaphylaxis) may occasionally occur. In case of occurrence of allergic reaction, the treatment should be withdrawn.

Very rarely (less than 1 animal in 10,000 animals treated, including isolated reports), use of the product may result in gastro-intestinal disorders (vomiting, diarrhoea, anorexia).

Use During Pregnancy, Lactation or Lay

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.

Interaction with other Medicinal Products and Other Forms of Interaction

Chloramphenicol, macrolides, sulfonamides and tetracyclines may inhibit the antibacterial effect of penicillins because of the rapid onset of bacteriostatic action. The potential for allergic cross-reactivity with other penicillins should be considered.

Penicillins may increase the effect of aminoglycosides.

Amounts to be Administered and Administration

Administration: by the oral route. Dosage rate: total 12.5 mg of combined actives/kg bw. (equal to 10 mg of amoxicillin + 2.5 mg of clavulanate/kg bw). Dosage frequency: The following table is intended as a guide to dispensing at the standard dose rate of 12.5 mg/kg bw, twice daily.

To ensure a correct dosage, bodyweight should be determined as accurately as possible.Body weight (kg)Number of tablets to be administered twice daily< 8Use 50 mg tablet[8.1 – 10.0]½[10.1 – 20.0]1[20.1 – 30.0]1 ½[30.1 – 40.0]2>40Use 500 mg tablet

Body weight (kg)

Number of tablets to be administered twice daily

< 8

Use 50 mg tablet

[8.1 – 10.0]

½

[10.1 – 20.0]

1

[20.1 – 30.0]

1 ½

[30.1 – 40.0]

2

>40

Use 500 mg tablet

If the dog or cat does not accept the tablet from hand or bowl, then the tablets may be crumbled and added to a little food.

The majority of routine cases respond after between 5 and 7 days therapy. If no improvement is observed after 5 – 7 days, the diagnosis should be re-assessed.

In chronic or refractory cases, a longer course of therapy may be required e.g. chronic skin disease 10 - 20 days, chronic cystitis 10 - 28 days, respiratory disease 8 - 10 days.

If no improvement is observed after two weeks, the diagnosis should be re-assessed.

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

Symptomatic treatment should be initiated when necessary.Mild gastrointestinal symptoms (diarrhoea, nausea and vomiting) may occur more frequently after overdose of the product.

Withdrawal Period(s)

Not applicable.

Pharmacological particulars

Pharmacotherapeutic group: Beta-lactam antibacterials, penicillins.

ATC Vet Code: QJ01CR02.

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

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

Gram-positive:

Gram-negative:

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

Dogs and cats diagnosed with Pseudomonas infections should not be treated with this antibiotic combination.

A trend in resistance of E. coli is reported.

Resistance

Acquired resistance prevalence may be high in E. coli.

Resistance notably develops through the production of inhibitor-resistant beta-lactamases or the hyperproduction of beta-lactamases.

In some strains of Staphylococcus aureus (methicillin-resistant S. aureus, MRSA), and of Staphylococcus pseudintermedius, resistance to all beta-lactams is conferred by the alteration of the cell wall target proteins (Penicillin-Binding Proteins). This is often associated to resistance to multiple other antimicrobial compounds with cross resistance.

Pseudomonas aeruginosa and Enterobacter spp. can be regarded as intrinsically resistant to the combination.

Pharmacokinetic properties

Amoxicillin is well-absorbed following oral administration. In dogs the systemic bioavailability is 60-70%. 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 (pK1 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 heavily eliminated by renal excretion (unchanged in urine).

After oral administration of the recommended dose of 12.5mg combined actives/kg to cats, the following parameters were observed: Cmax of 9.17 µg/ml and AUC of 53.27 µg.h/ml for amoxicillin and Cmax of 2.32 µg/ml, and AUC of 13.33 µg.h/ml for clavulanic acid.

After oral administration of the recommended dose of 12.5mg combined actives/kg to dogs, the following parameters were observed: Cmax of 8.92 µg/ml and AUC of 46.29 µg.h/ml for amoxicillin and Cmax of 2.21 µg/ml, and AUC of 8.99 µg.h/ml for clavulanic acid.

Pharmaceutical particulars

List of Excipient(s)

Sodium Starch Glycolate, type A

Povidone K30

Spray Dried Pork Liver Powder

Yeast Extract

Silica Colloidal Hydrated

Magnesium Stearate

Microcrystalline Cellulose

Incompatibilities

Not applicable.

Shelf-Life

Shelf-life of the veterinary medicinal product as packaged for sale: 1 year.

Discard any unused halved tablets immediately.

Special Precautions for Storage

Do not store above 30°C.

Store in a dry place.

Nature and Composition of Immediate Packaging

Blisters (aluminium/aluminium): 20, 50, 200, 250 and 500 tablets in outer packages with blister strips containing 5 tablets each.

Not all pack sizes may be marketed.

Special Precautions for the Disposal of Unused Veterinary Medicinal Products or Waste Materials Derived from the Use of Such Products, if appropriate

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

Marketing Authorisation Holder (if different from distributor)

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry

Co. Down

BT35 6JP

Northern Ireland

Marketing Authorisation Number

Vm 02000/4318

Date of the first authorisation or date of renewal

22 June 2012

Date of revision of the text

August 2017

Any other information

Nil.

Legal category

500mg » Priced per Tablet

SUMMARY OF PRODUCT CHARACTERISTICS

  1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Noroclav 250 mg Chewable Flavoured Tablets for Cats and Dogs (ROI [RMS], AT, BG, CY, HU, IT, EL, LV, LT, PL, RO, SK, SE, UK). Noroclav 200 mg/50 mg Chewable Flavoured Tablets for Cats and Dogs (CZ). Veclavam 250 mg Chewable Flavoured Tablets for Cats and Dogs (BE, ES, LU, NL, PT). Veclavam Flavour Vet. 200 mg/50 mg Tablets for Cats and Dogs (DK). Veclavam P 250 mg Chewable Tablets for Cats and Dogs (FR). Veclavam vet (NO).

  1. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains:

Active ingredients:
Amoxicillin 200.00 mg
(as Amoxicillin Trihydrate)
Clavulanic acid 50.00 mg
(as Potassium Clavulanate)

Excipients:
For the full list of excipients, see section 6.1.

  1. PHARMACEUTICAL FORM

Chewable Tablet. Pale brown circular tablet with two crossing score lines and embossed with ‘250’ on opposing faces. The tablets can be divided into equal halves.

  1. CLINICAL PARTICULARS

4.1 Target Species

Cats and Dogs.

4.2 Indications for Use, Specifying the Target Species

Treatment of the following infections caused by beta-lactamase producing strains of bacteria sensitive to amoxicillin in combination with clavulanic acid:

Skin infections (including superficial and deep pyodermas) caused by Staphylococcus spp. Urinary tract infections caused by Staphylococcus spp or Escherichia coli. Respiratory tract infections caused by Staphylococcus spp. Enteritis caused by Escherichia coli. Dental infections (e.g. gingivitis)

It is recommended to carry out suitable tests for sensitivity when initiating the treatment. The treatment should only proceed if sensitivity is proven to the combination.

4.3 Contraindications

The product should not be given to rabbits, hamsters, guinea pigs or gerbils. Do not use in animals with known hypersensitivity to penicillin, other beta-lactams or any of the excipients.Do not use in animals with serious dysfunction of the kidneys accompanied by anuria or oliguria. Do not use where resistance to this combination is known to occur. Do not administer to horses and ruminating animals.

4.4 Special Warnings for Each Target Species

None known.

4.5 Special Precautions for Use

Special precautions for use in animals

Whenever possible, the product should only be used based on susceptibility testing. Use of the product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to beta-lactam antimicrobials and may decrease the effectiveness of treatment with other classes of antimicrobials due to the potential for cross resistance.

Official and regional antimicrobial policies should be taken into account.

In animals with hepatic and renal failure, the dosing regimen should be carefully evaluated.

Caution is advised in their use in small herbivores.

The chewable tablets are flavoured. In order to avoid any accidental ingestion, store tablets out of reach of animals

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)

Hypersensitivity reactions to penicillins may occur in treated animals. Allergic reactions (e.g. skin reactions, anaphylaxis) may occasionally occur. In case of occurrence of allergic reaction, the treatment should be withdrawn. Very rarely (less than 1 animal in 10,000 animals treated, including isolated reports), use of the product may result in gastro-intestinal disorders (vomiting, diarrhoea, anorexia).

4.7 Use During Pregnancy, Lactation or Lay

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.

4.8 Interaction with other Medicinal Products and Other Forms of Interaction

Chloramphenicol, macrolides, sulfonamides and tetracyclines may inhibit the antibacterial effect of penicillins because of the rapid onset of bacteriostatic action. 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 Administration: by the oral route. Dosage rate: total 12.5 mg of combined actives/kg bw. (equal to 10 mg of amoxicillin + 2.5 mg of clavulanate/kg bw). Dosage frequency: The following table is intended as a guide to dispensing at the standard dose rate of 12.5 mg/kg bw, twice daily. To ensure a correct dosage, bodyweight should be determined as accurately as possible.

Body weight (kg) Number of tablets to be administered twice daily < 8 Use 50 mg tablet [8.1 – 10.0] ½ [10.1 – 20.0] 1 [20.1 – 30.0] 1 ½ [30.1 – 40.0] 2

40 Use 500 mg tablet

If the dog or cat does not accept the tablet from hand or bowl, then the tablets may be crumbled and added to a little food. The majority of routine cases respond after between 5 and 7 days therapy. If no improvement is observed after 5 – 7 days, the diagnosis should be re-assessed.

In chronic or refractory cases, a longer course of therapy may be required e.g. chronic skin disease 10 - 20 days, chronic cystitis 10 - 28 days, respiratory disease 8 - 10 days. If no improvement is observed after two weeks, the diagnosis should be re-assessed.

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

Symptomatic treatment should be initiated when necessary.Mild gastrointestinal symptoms (diarrhoea, nausea and vomiting) may occur more frequently after overdose of the product.

4.11 Withdrawal Period(s)

Not applicable.

  1. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Beta-lactam antibacterials, penicillins.

ATC Vet Code: QJ01CR02.

5.1 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 b-lactamase and therefore combination with an effective ß-lactamase inhibitor (clavulanic acid) extends the range of bacteria against which it is active to include b-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.

Dogs and cats diagnosed with Pseudomonas infections should not be treated with this antibiotic combination. A trend in resistance of E. coli is reported.

Resistance

Acquired resistance prevalence may be high in E. coli. Resistance notably develops through the production of inhibitor-resistant beta-lactamases or the hyperproduction of beta-lactamases. In some strains of Staphylococcus aureus (methicillin-resistant S. aureus, MRSA), and of Staphylococcus pseudintermedius, resistance to all beta-lactams is conferred by the alteration of the cell wall target proteins (Penicillin-Binding Proteins). This is often associated to resistance to multiple other antimicrobial compounds with cross resistance. Pseudomonas aeruginosa and Enterobacter spp. can be regarded as intrinsically resistant to the combination.

5.2 Pharmacokinetic properties

Amoxicillin is well-absorbed following oral administration. In dogs the systemic bioavailability is 60-70%. 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 (pK1 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 heavily eliminated by renal excretion (unchanged in urine).

After oral administration of the recommended dose of 12.5mg combined actives/kg to cats, the following parameters were observed: Cmax of 9.17 µg/ml and AUC of 53.27 µg.h/ml for amoxicillin and Cmax of 2.32 µg/ml, and AUC of 13.33 µg.h/ml for clavulanic acid.

After oral administration of the recommended dose of 12.5mg combined actives/kg to dogs, the following parameters were observed: Cmax of 8.92 µg/ml and AUC of 46.29 µg.h/ml for amoxicillin and Cmax of 2.21 µg/ml, and AUC of 8.99 µg.h/ml for clavulanic acid.

  1. PHARMACEUTICAL PARTICULARS

6.1 List of Excipient(s)

Sodium Starch Glycolate, type A
Povidone K30 Spray Dried Pork Liver Powder Yeast Extract Silica Colloidal Hydrated Magnesium Stearate Microcrystalline Cellulose

6.2 Incompatibilities

Not applicable.

6.3 Shelf-Life

Shelf-life of the veterinary medicinal product as packaged for sale: 1 year.

Discard any unused halved tablets immediately.

6.4 Special Precautions for Storage

Do not store above 30°C. Store in a dry place.

6.5 Nature and Composition of Immediate Packaging

Blisters (aluminium/aluminium): 20, 50, 200, 250 and 500 tablets in outer packages with blister strips containing 5 tablets each.

Not all pack sizes may be marketed.

6.6 Special Precautions for the Disposal of Unused Veterinary Medicinal Products or Waste Materials Derived from the Use of Such Products, if appropriate

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

  1. MARKETING AUTHORISATION HOLDER

Norbrook Laboratories Limited Station Works Camlough Road Newry Co. Down BT35 6JP Northern Ireland

  1. MARKETING AUTHORISATION NUMBER

Vm 02000/4318

  1. DATE OF FIRST AUTHORISATION

22 June 2012

  1. DATE OF REVISION OF THE TEXT

August 2017

Approved 02 August 2017

Chewable » 250mg » Priced per Tablet

Noroclav 250 mg Chewable Flavoured Tablets for Cats and Dogs

Qualitative and quantitative composition

Each tablet contains: Active substance(s): Amoxicillin (as amoxicillin trihydrate) 200 mgClavulanic acid (as Potassium Clavulanate)50 mgExcipients:For a full list of excipients, see section Pharmaceutical Particulars

Active substance(s):

Amoxicillin (as amoxicillin trihydrate)

200 mg

Clavulanic acid (as Potassium Clavulanate)

50 mg

Excipients:

For a full list of excipients, see section Pharmaceutical Particulars

Pharmaceutical form

Chewable Tablet.

Pale brown circular tablet with two crossing score lines and embossed with ‘250’ on opposing faces.

The tablets can be divided into equal halves.

Clinical particulars

Target Species

Cats and Dogs.

Indications for Use, Specifying the Target Species

Treatment of the following infections caused by beta-lactamase producing strains of bacteria sensitive to amoxicillin in combination with clavulanic acid:

It is recommended to carry out suitable tests for sensitivity when initiating the treatment. The treatment should only proceed if sensitivity is proven to the combination.

Contraindications

The product should not be given to rabbits, hamsters, guinea pigs or gerbils. Do not use in animals with known hypersensitivity to penicillin, other beta-lactams or any of the excipients.Do not use in animals with serious dysfunction of the kidneys accompanied by anuria or oliguria.

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

Do not administer to horses and ruminating animals.

Special Warnings for Each Target Species

None known.

Special Precautions for Use

Special precautions for use in animals

Whenever possible, the product should only be used based on susceptibility testing.

Use of the product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to beta-lactam antimicrobials and may decrease the effectiveness of treatment with other classes of antimicrobials due to the potential for cross resistance.

Official and regional antimicrobial policies should be taken into account.

In animals with hepatic and renal failure, the dosing regimen should be carefully evaluated.

Caution is advised in their use in small herbivores.

The chewable tablets are flavoured. In order to avoid any accidental ingestion, store tablets out of reach of animals.

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 (Frequency and Seriousness)

Hypersensitivity reactions to penicillins may occur in treated animals.

Allergic reactions (e.g. skin reactions, anaphylaxis) may occasionally occur. In case of occurrence of allergic reaction, the treatment should be withdrawn.

Very rarely (less than 1 animal in 10,000 animals treated, including isolated reports), use of the product may result in gastro-intestinal disorders (vomiting, diarrhoea, anorexia).

Use During Pregnancy, Lactation or Lay

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.

Interaction with other Medicinal Products and Other Forms of Interaction

Chloramphenicol, macrolides, sulfonamides and tetracyclines may inhibit the antibacterial effect of penicillins because of the rapid onset of bacteriostatic action. The potential for allergic cross-reactivity with other penicillins should be considered.

Penicillins may increase the effect of aminoglycosides.

Amounts to be Administered and Administration

Administration: by the oral route. Dosage rate: total 12.5 mg of combined actives/kg bw. (equal to 10 mg of amoxicillin + 2.5 mg of clavulanate/kg bw). Dosage frequency: The following table is intended as a guide to dispensing at the standard dose rate of 12.5 mg/kg bw, twice daily.

To ensure a correct dosage, bodyweight should be determined as accurately as possible.Body weight (kg)Number of tablets to be administered twice daily< 8Use 50 mg tablet[8.1 – 10.0]½[10.1 – 20.0]1[20.1 – 30.0]1 ½[30.1 – 40.0]2>40Use 500 mg tablet

Body weight (kg)

Number of tablets to be administered twice daily

< 8

Use 50 mg tablet

[8.1 – 10.0]

½

[10.1 – 20.0]

1

[20.1 – 30.0]

1 ½

[30.1 – 40.0]

2

>40

Use 500 mg tablet

If the dog or cat does not accept the tablet from hand or bowl, then the tablets may be crumbled and added to a little food.

The majority of routine cases respond after between 5 and 7 days therapy. If no improvement is observed after 5 – 7 days, the diagnosis should be re-assessed.

In chronic or refractory cases, a longer course of therapy may be required e.g. chronic skin disease 10 - 20 days, chronic cystitis 10 - 28 days, respiratory disease 8 - 10 days.

If no improvement is observed after two weeks, the diagnosis should be re-assessed.

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

Symptomatic treatment should be initiated when necessary.Mild gastrointestinal symptoms (diarrhoea, nausea and vomiting) may occur more frequently after overdose of the product.

Withdrawal Period(s)

Not applicable.

Pharmacological particulars

Pharmacotherapeutic group: Beta-lactam antibacterials, penicillins.

ATC Vet Code: QJ01CR02.

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

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

Gram-positive:

Gram-negative:

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

Dogs and cats diagnosed with Pseudomonas infections should not be treated with this antibiotic combination.

A trend in resistance of E. coli is reported.

Resistance

Acquired resistance prevalence may be high in E. coli.

Resistance notably develops through the production of inhibitor-resistant beta-lactamases or the hyperproduction of beta-lactamases.

In some strains of Staphylococcus aureus (methicillin-resistant S. aureus, MRSA), and of Staphylococcus pseudintermedius, resistance to all beta-lactams is conferred by the alteration of the cell wall target proteins (Penicillin-Binding Proteins). This is often associated to resistance to multiple other antimicrobial compounds with cross resistance.

Pseudomonas aeruginosa and Enterobacter spp. can be regarded as intrinsically resistant to the combination.

Pharmacokinetic properties

Amoxicillin is well-absorbed following oral administration. In dogs the systemic bioavailability is 60-70%. 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 (pK1 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 heavily eliminated by renal excretion (unchanged in urine).

After oral administration of the recommended dose of 12.5mg combined actives/kg to cats, the following parameters were observed: Cmax of 9.17 µg/ml and AUC of 53.27 µg.h/ml for amoxicillin and Cmax of 2.32 µg/ml, and AUC of 13.33 µg.h/ml for clavulanic acid.

After oral administration of the recommended dose of 12.5mg combined actives/kg to dogs, the following parameters were observed: Cmax of 8.92 µg/ml and AUC of 46.29 µg.h/ml for amoxicillin and Cmax of 2.21 µg/ml, and AUC of 8.99 µg.h/ml for clavulanic acid.

Pharmaceutical particulars

List of Excipient(s)

Sodium Starch Glycolate, type A

Povidone K30

Spray Dried Pork Liver Powder

Yeast Extract

Silica Colloidal Hydrated

Magnesium Stearate

Microcrystalline Cellulose

Incompatibilities

Not applicable.

Shelf-Life

Shelf-life of the veterinary medicinal product as packaged for sale: 1 year.

Discard any unused halved tablets immediately.

Special Precautions for Storage

Do not store above 30°C.

Store in a dry place.

Nature and Composition of Immediate Packaging

Blisters (aluminium/aluminium): 20, 50, 200, 250 and 500 tablets in outer packages with blister strips containing 5 tablets each.

Not all pack sizes may be marketed.

Special Precautions for the Disposal of Unused Veterinary Medicinal Products or Waste Materials Derived from the Use of Such Products, if appropriate

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

Marketing Authorisation Holder (if different from distributor)

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry

Co. Down

BT35 6JP

Northern Ireland

Marketing Authorisation Number

Vm 02000/4318

Date of the first authorisation or date of renewal

22 June 2012

Date of revision of the text

August 2017

Any other information

Nil.

Legal category

Chewable » 50mg » Priced per Tablet

Noroclav 50 mg Tablets for Dogs and Cats

Qualitative and quantitative composition

Each tablet contains:Active substance(s): Amoxicillin (as amoxicillin trihydrate) 40 mgClavulanic acid (as Potassium Clavulanate)10 mgExcipients:Carmoisine Lake (E122)0.245 mgFor a full list of excipients, see section Pharmaceutical Particulars

Active substance(s):

Amoxicillin (as amoxicillin trihydrate)

40 mg

Clavulanic acid (as Potassium Clavulanate)

10 mg

Excipients:

Carmoisine Lake (E122)

0.245 mg

For a full list of excipients, see section Pharmaceutical Particulars

Pharmaceutical form

Tablet.

Round pink biconvex tablet with a score line and 50 embossed on opposing faces.

Clinical particulars

Target Species

Dogs and cats.

Indications for Use, Specifying the Target Species

Treatment of the following infections caused by b lactamase producing strains of bacteria sensitive to amoxicillin in combination with clavulanic acid:

It is recommended to carry out suitable tests for sensitivity testing when initiating the treatment. The treatment should only proceed if sensitivity is proven to the combination.

Contraindications

Do not use in animals with known hypersensitivity to penicillin or other substances of the beta-lactam group.

Do not use in rabbits, guinea pigs, hamsters or gerbils.

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

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

Do not administer to horses and ruminating animals.

Special Warnings for Each Target Species

None.

Special Precautions for Use

Special precautions for use in animals

Inappropriate use of the product may increase the prevalence of bacteria resistant to amoxicillin/clavulanic acid.

In animals with hepatic and renal failure, the dosing regimen should be carefully evaluated.

Use of the product should be based on susceptibility testing and take into account official and local antimicrobial policies. Narrow spectrum antibacterial therapy should be used for first line treatment where susceptibility testing suggests likely efficacy of this approach.

Caution is advised in the use in small herbivores other than those in section, Contraindications.

Dogs and cats diagnosed with Pseudomonas infections should not be treated with this antibiotic combination.

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 (Frequency and Seriousness)

Hypersensitivity reactions unrelated to dose can occur with these agents.

Gastrointestinal symptoms (diarrhoea, vomiting) may occur after administration of the product.

Allergic reactions (e.g. skin reactions, anaphylaxia) may occasionally occur.

In case of occurrence of allergic reaction, the treatment should be withdrawn.

Use During Pregnancy, Lactation or Lay

Studies in laboratory animals have not produced any evidence of teratogenic effects.

Use only according to the benefit/risk assessment by the responsible veterinarian.

Interaction with other Medicinal Products and Other Forms of Interaction

Chloramphenicol, macrolides, sulfonamides and tetracyclines may inhibit the antibacterial effect of penicillins because of the rapid onset of bacteriostatic action. The potential for allergic cross-reactivity with other penicillins should be considered.

Penicillins may increase the effect of aminoglycosides.

Amounts to be Administered and Administration

Administration is via the oral route. The dosage rate is 12.5 mg combined actives/kg bodyweight twice daily. The tablets may be crushed and added to a little food.

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 twice daily.BodyweightNumber of tablets twice daily1-2½3-415-61,57-829-102,511-12313-143,515-16417-184,5

Bodyweight

Number of tablets twice daily

1-2

½

3-4

1

5-6

1,5

7-8

2

9-10

2,5

11-12

3

13-14

3,5

15-16

4

17-18

4,5

Duration of therapy

Acute cases: 5 to 7 days of treatment.

If no improvement is observed after 5 to 7 days, the diagnosis should be re-assessed.

Chronic or refractory cases: In these cases where there is considerable tissue damage, a longer course of therapy may be required so that it allows sufficient time for damaged tissue to repair.

If no improvement is observed after two weeks, the diagnosis should be re-assessed.

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

The product is of a low order of toxicity and is well tolerated by the oral route.

In a tolerance study in dogs a tested dose of 3 times the recommended dose of 12.5mg of the combined actives administered twice daily for 8 days did not demonstrate adverse effects.

In a tolerance study in cats a tested dose of 3 times the recommended dose of 12.5mg of the combined actives administered twice daily for 15 days did not demonstrate adverse effects.

Withdrawal Period(s)

Not applicable.

Pharmacological particulars

Pharmacotherapeutic group: Beta-lactam antibacterials, penicillins

ATCvet code: QJ01CR02

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

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

Gram-positive:

Gram-negative:

Resistance is shown among Enterobacter spp, Pseudomonas aeruginosa and methicillin-resistant Staphylococcus aureus. A trend in resistance of E. coli is reported.

Pharmacokinetic properties

Amoxicillin is well-absorbed following oral administration. In dogs the systemic bioavailability is 60-70%. 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 (pK1 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 heavily eliminated by renal excretion (unchanged in urine).

After oral administration of the recommended dose of 12.5mg combined actives/kg to dogs, the following parameters were observed: Cmax of 6.30 +/-0.45µg/ml, Tmax of 1.98 +/- 0.135h and AUC of 23.38 +/- 1.39 µg/ml.h for amoxicillin and Cmax of 0.87 +/- 0.1µg/ml, Tmax of 1.57 +/- 0.177hrs and AUC of 1.56 +/- 0.24mg/ml.h for clavulanic acid.

After oral administration of the recommended dose of 12.5mg combined actives/kg to cats, the following parameters were observed: Cmax of 7.12 +/-1.460 µg/ml, Tmax of 2.69 +/- 0.561 h and AUC of 33.54 +/- 7.335 µg/ml.h for amoxicillin and Cmax of 1.67 +/- 0.381 µg/ml, Tmax of 1.83 +/- 0.227 h and AUC of 7.03 +/- 1.493 µg/ml.h for clavulanic acid.

Pharmaceutical particulars

List of Excipient(s)

Carmosine Lake (E122)

Sodium Starch Glycollate

Copovidone K24-36

Magnesium Stearate

Microcrystalline Cellulose

Calcium Carbonate

Heavy Magnesium carbonate

Roast Beef Flav-o-lok

Incompatibilities

Not applicable.

Shelf-Life

Shelf-life of the veterinary medicinal product as packaged for sale:

2 years (blister packs), 6 months (tubs).

Special Precautions for Storage

Do not store above 25°C. Store in the original package in order to protect from moisture.

Nature and Composition of Immediate Packaging

The product is supplied in high-density polyethylene tubs with a polypropylene screw cap lid containing 100 tablets and in high-density polyethylene tubs with a polyethylene screw cap lid containing 500 tablets. A sachet of desiccant is included in each container. The product is also presented in packs containing 2, 10 and 50 blister strips (aluminium-aluminium) each containing 10 tablets per strip.

Not all pack sizes may be marketed.

Special Precautions for the Disposal of Unused Veterinary Medicinal Products or Waste Materials Derived From the Use of Such Products, if appropriate

Any unused product or waste material should be disposed of in accordance with national requirements.

Marketing Authorisation Holder (if different from distributor)

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry

Co. Down

BT35 6JP

Northern Ireland

Marketing Authorisation Number

Vm 02000/4211

Date of the first authorisation or date of renewal

25th February 2009

Date of revision of the text

November 2011

Any other information

Nil.

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 (4)

Q & A

Below are some recent questions we've received regarding Noroclav Tablets, including answers from our team.

16 January 2019 at 8:45am

Dog doesnt eat cant get tablet down

Richard Willingham

are these tablets solouble

  • Veterinary Advisor

If your dog will not accept the tablets whole then it would be best to crumble it and mix it in with food.

14 October 2015 at 2:55pm

Noroclav

Nancy

Is this producy for UTI. for fogs

  • Non-Executive Director

This is a good product for UTI, though culture and sensitivity is still best to do first if possible.

24 July 2015 at 12:49pm

3 week old puppy

vic

can 3 week old puppy have Noroclav ?

  • Non-Executive Director

Yes if there is sufficient reason to believe that antibiotic is needed, then this is generally a safe and effective one to choose.