Introduction

Company name: Fort Dodge Animal Health

Address: Flanders Road

Hedge End

Southampton SO30 4QH

Telephone: 01489 781711

Fax: 01489 788306

Presentation

Nisamox Injection is an off-white suspension containing amoxicillin 140mg/ml as amoxicillin trihydrate and clavulanic acid 35mg/ml as potassium clavulanate in an oily base. Excipients: butylated hydroxyanisole 0.08mg and butylated hydroxtoluene 0.08mg.

Uses

In vitro Nisamox Injection is active against a wide range of clinically

important bacteria including:

Gram-positive:

Staphylococci (including beta-lactamase producing strains), Streptococci, Corynebacteria, Clostridia.

Gram-negative:

Escherichia coli, Campylobacter spp, Klebsiella spp, Proteus spp, Pasteurella spp, Bacteroides spp (including beta-lactamase producing strains) and Haemophilus spp.

Nisamox Injection is effective in cattle for treatment of respiratory infections and soft tissue infections (e.g. joint/navel ill, abscesses etc.).

Dosage and administration

By intramuscular injection at a dosage rate of 8.75mg/kg bodyweight

[7mg/kg bodyweight amoxicillin and 1.75mg/kg/bodyweight of clavulanic acid] (1ml per 20kg bodyweight) once daily for 3-5 days.

Shake before use. Use a completely dry sterile needle and syringe. Swab the septum before removing each dose. The suspension is not suitable for intravenous or intrathecal administration. The maximum volume administered at the site of injection should not exceed 10ml.

Contra-indications, warnings, etc

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. The use of the product is contra-indicated where resistance to the combination of penicillins is known to occur. Diarrhoea and sweating may rarely occur after administration of the product. Local tissue reactions at the site of injection may occur following administration. These reactions are generally of mild to moderate swelling and/or hardness and can persist for up to 2 weeks following administration at the recommended dose rate in the rump or leg muscles and 4 days after administration at the recommended dose rate in the neck muscles. Pain on injection may occasionally occur. In case of the occurrence of allergic reaction, the treatment should be withdrawn. 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 regime 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 the likely efficacy of this approach.

The safety of the product has not been assessed in pregnant and lactating cows.

Operator 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.

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. In case of accidental contact with eyes, rinse immediately with plenty of water.

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.

Withdrawal periods

Milk for human consumption must not be taken during treatment. Milk for human consumption may be taken from treated cattle only after 60 hours (5 milkings) from the last treatment.

Animals must not be slaughtered for human consumption during treatment.

Cattle may be slaughtered for human consumption only after 42 days from the last treatment.

Pharmaceutical precautions

Do not store above 25°C.

Store out of the reach of children.

Once the vial has been broached the contents should be used within 28 days.

When the container is broached (opened) for the first time, the date on which any product remaining in the container should be discarded should be calculated. A statement of the in use shelf life of the product is given on the package. This discard date should be written in the space provided on the label.

Clavulanic acid is moisture sensitive. It is very important, therefore, that a completely dry syringe is used when extracting suspension for injection to avoid contaminating the remaining contents of the vial with water. Contamination will result in distinct beads of dark, brown discolouration corresponding to the introduced water droplets. Material affected in this way should not be used as it may have significantly reduced potency.

Disposal

Dispose of any unused product and empty containers in accordance with guidance from you local waste regulation authority.

Legal category

POM-V

Packaging Quantities

50ml/100ml multidose

Further information

Resistance to many antibiotics is caused by beta-lactamase enzymes which destroy the antibiotic before it can act on the bacteria themselves. The clavulanate acid in Nisamox Injection counteracts this defence mechanism by inactivating the beta-lactamases, thus rendering the bacteria sensitive to amoxicillin’s rapid bactericidal effect, at concentrations readily attainable in the body.

Marketing authorisation number

Vm: 02000/4227.