SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Noroclav 250 mg Tablets for dogs

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains:

Active Ingredients:

Amoxicillin (as amoxicillin trihydrate) 200 mg

Clavulanic acid (as Potassium clavulanate) 50.0 mg Excipients:

Qualitative composition of excipients and other constituents	Quantitative composition if that information is essential for proper administration of the veterinary medicinal product
Carmoisine Lake (E122)	1.225 mg
Sodium Starch Glycollate
Silicon Dioxide
Copovidone
Magnesium Stearate
Microcrystalline Cellulose
Calcium Carbonate
Heavy Magnesium carbonate
Roast Beef Flav-o-lok

Round pink tablet with a score line and 250 embossed on opposing faces.

3. CLINICAL INFORMATION

3.1 Target species

Dogs.

3.2 Indications for use for each target species

Dogs:

For the treatment of

- Skin infections (including deep and superficial pyoderma).

- Soft tissue infections (including anal sacculitis and abscesses).

- Urinary tract infections.

- Respiratory infections.

- Intestinal infections.

- Periodontal infections in addition to mechanical or surgical periodontal therapy.

3.3 Contraindications

Do not use in cases of known hypersensitivity to the active substance, other substances of the beta-lactam group or to any of the excipients.

Do not use in rabbits, guinea pigs, hamsters, gerbils, chinchillas or other small herbivores.

Do not use in animals with severe renal impairment with anuria and oliguria. Do not use where resistance to this combination is known to occur.

3.4 Special warnings

Cross-resistance has been shown between amoxicillin/clavulanic acid and other antibiotics belonging to the beta-lactam group. Use of the veterinary medicinal product should be carefully considered when susceptibility testing has shown resistance to other antimicrobials in the beta-lactam group because its effectiveness may be reduced. When susceptibility testing has shown resistance to sole beta-lactam, but susceptibility to combination of amoxicillin/clavulanic acid has been confirmed, treatment with the veterinary medicinal product might nevertheless be considered.

Do not use in cases of suspected or confirmed methicillin resistant S. aureus (MRSA) and methicillin resistance S. pseudintermedius (MRSP) infections, such as isolates should be considered resistant to all beta-lactams including amoxicillin/clavulanic acid combinations.

The veterinary medicinal product has no effect against infections caused by Pseudomonas spp. Due to its inherent resistance.

3.5 Special precautions for use

Special precautions for safe use in the target species:

Use of the product should be based on identification and susceptibility testing of the target pathogen(s). If this is not possible, therapy should be based on epidemiological information and knowledge of susceptibility of the target pathogens at local/regional level.

Use of the product should be in accordance with official, national and regional antimicrobial policies.

An antibiotic with a lower risk of antimicrobial resistance selection (lower AMEG category) should be used for the first line of treatment where susceptibility testing suggests the likely efficacy of this approach.

Narrow spectrum antibiotic therapy with a lower risk of antimicrobial resistance selection should be used for the first line treatment where susceptibility testing suggests the likely efficacy of this approach. Pharmacokinetic of the active substances in the target tissue might be considered as well.

The routine use of systemic antibiotics for intestinal infections is not recommended.

Oral treatment with antibiotics can result in disturbance of gastrointestinal flora, especially in case of long-term treatment.

In case of renal or hepatic insufficiency, the use of the veterinary medicinal product should be subject to a benefit-risk assessment by the responsible veterinarian.

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 can lead to cross-reactions with cephalosporins and vice versa. Allergic reactions caused by these substances may occasionally be serious. People with known hypersensitivity to the active substance should avoid contact with the veterinary medicinal product. Wear gloves when handling this product to avoid skin contact.

If you develop symptoms such as a skin rash and persistent eye irritation after exposure to the veterinary medicinal product, seek medical advice immediately and show the package leaflet or label to the physician. Swelling of the face, lips or eyes or difficulty with breathing are more serious symptoms and require urgent medical attention.

Wash hands after use.

To prevent children from accessing the veterinary medicinal product, only the required number of tablets should be removed from the blister pack and only when required. Store any unused portion of the tablet in the opened blister pack and return it into the carton immediately after use. The carton should be stored out of the sight and reach of children. In case of accidental ingestion, seek medical advice immediately and show the package leaflet or label to the physician.

Special precautions for the protection of the environment:

Not applicable.

3.6 Adverse events

Dogs.

Common (1 to 10 animals / 100 animals treated):	Gastrointestinal disorder1 (e.g. vomiting, diarrhoea)
Uncommon (1 to 10 animals / 1 000 animals treated):	Hypersalivation Anorexia1, Lethargy
Very rare (<1 animal / 10,000 animals treated, including isolated reports):	Hypersensitivity reaction2 (e.g. allergic skin reaction, anaphylaxis)

¹ Depending on the severity of the adverse event, treatment should be discontinued and symptomatic treatment initiated based on the benefit-risk assessment by the responsible veterinarian.

² May be serious. Immediate discontinuation of the veterinary medicinal product is required. Countermeasures to be taken in case of an allergic reaction:

- Anaphylaxis: administer epinephrine (adrenaline) and glucocorticoids.

- Allergic skin reactions: administer antihistamines and/or glucocorticoids.

Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or the national competent authority via the national reporting system. See the package leaflet for respective contact details.

3.7 Use during pregnancy, lactation or lay

The safety of the veterinary medicinal product has not been established during pregnancy and lactation.

Pregnancy and lactation:

In laboratory studies (rat, mouse), signs of embryotoxicity or teratogenicity could only be detected at high doses.

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

3.8 Interaction with other medicinal products and other forms of interaction

The bactericidal effect of amoxicillin may be inhibited by the concomitant use of bacteriostatic antimicrobials.

Penicillins may increase the effect of aminoglycosides.

3.9 Administration routes and dosage

Oral use.

Dosage: 10 mg amoxicillin and 2.5 mg clavulanic acid/kg body weight every 12 hours.

In refractory respiratory tract infections, the dose can be doubled to 20 mg amoxicillin and 5 mg clavulanic acid/kg body weight every 12 hours and the treatment prolonged for up to 10 days.

Dosing instructions:

Bodyweight (kg)	Number of tablets twice daily
19-20	1
21-30	1.5
31-40	2
41-50	2.5
More than 50	3

Duration of treatment:

In most cases a treatment duration of 5 and 7 days is sufficient. For chronic cases, a longer course of therapy may be required.

Based on clinical trials, the following treatment durations are recommended.

Chronic skin infections, 10 – 20 days. Chronic cystitis, 10 – 28 days.

Instructions for use.

To ensure correct dosage, body weight should be determined as accurately as possible.

The tablets can be administered directly into the mouth of the animal or crumbled and added to a small quantity of food and fed immediately.

3.10 Symptoms of overdose (and where applicable, emergency procedures and antidotes)

Doses of up to 40 mg amoxicillin and 10 mg clavulanic acid/kg and 60 mg amoxicillin and 15 mg clavulanic acid/kg administered twice daily for 5 days were tolerated well in young dogs and young cats respectively.

No adverse events associated with overdoses other than those listed in section 3.6 were detected in the respective studies (for information on symptomatic treatment see also section on adverse events).

Due to the neurotoxicity of penicillins, overdosing might result in central nervous system symptoms and convulsions. In these cases, treatment with the veterinary medicinal product should be discontinued immediately and symptomatic treatment should be initiated.

3.11 Special restrictions for use and special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance

For administration only by a veterinarian.

3.12 Withdrawal periods

Not applicable.

4. PHARMACOLOGICAL INFORMATION

4.1 ATCvet code: QJ01CR02

4.2 Pharmacodynamics

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

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

Clavulanic acid is one of the naturally occurring metabolites of the streptomycete Streptomyces clavuligerus. It has a structural similarity to the penicillin nucleus, including possession of a beta-lactam ring. Clavulanic acid is a beta-lactamase inhibitor acting initially competitively but ultimately irreversibly. Clavulanic acid will penetrate the bacterial cell wall binding to both extracellular and intracellular beta-lactamases. Amoxicillin is susceptible to breakdown by ß-lactamase and therefore combination with an effective ß-lactamase inhibitor (clavulanic acid) extends the range of bacteria against which it is active to include ß-lactamase producing species.

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

Gram-positive:

Staphylococci (including ß-lactamase producing strains)

Clostridia

Streptococci

Gram-negative:

Escherichia coli (including most ß-lactamase producing strains) Campylobacter spp. Pasteurellae Proteus spp.

Resistance is shown among Enterobacter spp., Pseudomonas aeruginosa and methicillin-resistant Staphylococcus aureus. Dogs diagnosed with pseudomonas infections should not be treated with this antibiotic combination. A trend in resistance of E. coli is reported.

4.3 Pharmacokinetics

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 +/- 0.24 microgram/ml.h for clavulanic acid.

5. PHARMACEUTICAL PARTICULARS

5.1 Major incompatibilities

Not applicable.

5.2 Shelf life

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

Blister packs: 2 years. Tubs: 6 months.

5.3 Special precautions for storage

Do not store above 25ºC.

Store in the original package in order to protect from moisture.

5.4 Nature and composition of immediate packaging

The product is supplied in high-density polyethylene tubs with a polyethylene screw cap lid containing 100 and 250 tablets. A sachet of desiccant is included in each container. The product is also presented in packs of 2, 4, 10, 20 and 50 blister strips (aluminiumaluminium) each containing 5 tablets per strip. Not all pack sizes may be marketed.

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

Medicines should not be disposed of via wastewater.

Use take-back schemes for the disposal of any unused veterinary medicinal product or waste materials derived thereof in accordance with local requirements and with any national collection systems applicable to the veterinary medicinal product concerned.

6. NAME OF THE MARKETING AUTHORISATION HOLDER

Norbrook Laboratories Limited

7. MARKETING AUTHORISATION NUMBER

Vm 02000/5012

8. DATE OF FIRST AUTHORISATION

08 March 2002

9. DATE OF THE LAST REVISION OF THE SUMMARY OF THE PRODUCT CHARACTERISTICS

September 2026

10. CLASSIFICATION OF VETERINARY MEDICINAL PRODUCT

Veterinary medicinal product subject to prescription.

Find more product information by searching for the ‘Product Information Database’ on www.gov.uk.

Gavin Hall Approved: 12 October 2026