Introduction

FDAH

Address: Flanders Road

Hedge End

Southampton SO30 4QH

Telephone: 01489 781711

Fax: 01489 788306

Presentation

For oral administration to dogs. Each Nisamox Palatable Tablet 500 mg contains Amoxicillin 400 mg (as Amoxicillin Trihydrate Ph.Eur) and Clavulanic Acid 100 mg (as Potassium Clavulanate Ph.Eur).

Uses

For the 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 susceptible Staphylococci.

- Urinary tract infections caused by susceptible Staphylococci or Escherichia coli.

- Respiratory infections caused by susceptible Staphylococci.

- Enteritis caused by susceptible Escherichia coli.

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

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

Gram-positive: Staphylococci (including β-lactamase producing strains), Clostridia, Streptococci. Gram-negative: Escherichia coli (including most β-lactamase producing strains), Campylobacter spp Pasteurellae, Proteus spp.

Dosage and administration

Administration is via the oral route. The tablets may be crushed and added to a little food.

Dosage rate: 12.5 mg combined actives/kg bodyweight twice daily.

Dosage frequency: The following table is intended as a guide to dispensing Nisamox Palatable Tablets at the standard dose rate of 12.5 mg/kg twice daily.

	Number of Tablets per dose twice daily
Bodyweight (kg)	500 mg
20 kg	◖
40 kg	●
60 kg	● ◖
80kg	● ●

Duration of therapy:

Routine cases involving all indications: The majority of cases respond to between 5 and 7 days therapy.

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

Contra-indications, warnings, etc

FOR ANIMAL TREATMENT ONLY

Do not use in animals with known cases of hypersensitivity to penicillins 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 kidneys accompanied by anuria or oliguria.

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

Do not administer to horses and ruminating animals.

Adverse reactions:

Hypersensitivity 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.

If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.

Withdrawal period: Not applicable

Special warnings:

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.

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.

Pharmaceutical precautions

Do not store above 25oC; store in a dry place.

Any halved tablet should be returned to the open blister and used within one day.

Keep out of reach and sight of children.

Legal category

POM-V

Packaging Quantities

Packs of 2, 4, 5 and 20 blister strips containing 5 tablets per strip.

Not all pack sizes may be marketed.

Further information

Amoxicillin is a broad-spectrum antibiotic active against a wide range of gram-positive and gram-negative bacteria. However, many clinically important bacteria produce beta-lactamase enzymes which destroy this antibiotic. Clavulanic acid inactivates these enzymes, rendering the organisms susceptible to the amoxicillin.

Studies in laboratory animals have not produced any evidence of teratogenic effects. Use only according to the risk/benefit assessment by the responsible veterinarian.

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