Noroclav 75 mg Chewable Flavoured Tablets for Cats and Dogs

Ireland - English - HPRA (Health Products Regulatory Authority)

Active ingredient:
Amoxicillin ; Clavulanic acid
Available from:
Norbrook Laboratories Limited
ATC code:
QJ01CR02
INN (International Name):
Amoxicillin ; Clavulanic acid
Dosage:
75 mg/tablet
Pharmaceutical form:
Chewable tablet
Prescription type:
POM: Prescription Only Medicine as defined in relevant national legislation
Therapeutic group:
Cats, Dogs
Therapeutic area:
amoxicillin and enzyme inhibitor
Therapeutic indications:
Antibacterial
Authorization status:
Authorised
Authorization number:
VPA10999/132/004
Authorization date:
2014-03-07

Read the complete document

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1 NAME OF THE VETERINARY MEDICINAL PRODUCT

Noroclav 75 mg Chewable Flavoured Tablets for Cats and Dogs

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains:

Active ingredients:

Amoxicillin 60.00 mg

(as Amoxicillin Trihydrate)

Clavulanic acid 15.00 mg

(as Potassium Clavulanate)

Excipients:

For the full list of excipients, see section 6.1

3 PHARMACEUTICAL FORM

Chewable Tablet.

Pale brown circular tablet with a score line and embossed with ‘75’ on opposing

faces.The tablets can be divided into equal halves.

4 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

Staphylococcusspp.

Urinary tract infections caused by Staphylococcus spp. or Escherichia coli.

Respiratory tract infections caused by Staphylococcusspp.

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

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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)

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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 route

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

< 2

Use 50 mg tablets

2.1 - 3.0

3.1 - 6.0

6.1 - 9.0

1 ½

9.1 - 12.0

>12

Use 250 or 500 mg tablets

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.

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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.

5 PHARMACOLOGICAL or IMMUNOLOGICAL 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 -lactamase and therefore combination

with an effective ß-lactamase inhibitor (clavulanic acid) extends the range of bacteria

against which it is active to include -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.

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Gram-negative:

Escherichia coli(including most b-lactamase producing strains)

Pasteurellaspp.

Proteusspp.

Resistance is shown among Enterobacterspp., Pseudomonas aeruginosaand

methicillin-resistantStaphylococcus aureus.

Dogs and cats diagnosed with Pseudomonasinfections should not be treated with

this antibiotic combination.

A trend in resistance of E. coliis 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 12.5 mg combined actives/kg

to cats, the following parameters were observed: C

of 9.17 µg/ml and AUC of

53.27 µg.h/ml foramoxicillin and C

of 2.32 µg/ml, and AUC of 13.33 µg.h/ml for

clavulanic acid.

After oral administration of the recommended dose of 12.5 mg combined actives/kg

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to dogs, the following parameters were observed: C

of 8.92 µg/ml and AUC of

46.29 µg.h/ml foramoxicillin and C

of 2.21 µg/ml, and AUC of 8.99 µg.h/ml for

clavulanic acid.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

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: 15 months

Discard any unused halved tablets immediately.

6.4 Special precautions for storage

Do not store above 25°C.

Store in a dry place.

6.5 Nature and composition of immediate packaging

Blisters (aluminium/aluminium): 28, 56, 224 and 504 tablets in outer packages with

blister strips containing 14 tablets each.

Not all pack sizes may be marketed.

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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 product should be disposed of in accordance with local

requirements.

7 MARKETING AUTHORISATION HOLDER

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry

Co. Down

BT35 6JP

United Kingdom

8 MARKETING AUTHORISATION NUMBER(S)

VPA 10999/132/004

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 7

March 2014

Date of last renewal: 4

August 2017

10 DATE OF REVISION OF THE TEXT

August 2017

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