Nisamox Lactating Cow

Introduction

Company name: Fort Dodge Animal Health

Address: Flanders Road

Hedge End

Southampton SO30 4QH

Telephone: 01489 781711

Fax: 01489 788306

Presentation

Nisamox Lactating Cow is an off-white to cream suspension nominally containing 200mg amoxicillin (as amoxicillin trihydrate Ph.Eur), 50mg clavulanic acid (as potassium clavulanate Ph.Eur) and 10mg prednisolone Ph.Eur. per 3g syringe.

Uses

Nisamox Lactating Cow is specially formulated for the treatment of bovine mastitis.

Nisamox Lactating Cow has a notably broad spectrum of bactericidal activity against the bacteria commonly found in the bovine udder.

The prednisolone in Nisamox Lactating Cow has an anti-inflammatory action which helps to reduce the potentially destructive swelling and inflammation associated with mastitis, without affecting the white cell response to infection.

In vitro, Nisamox Lactating Cow is active against a wide range of clinically important bacteria including the following organisms which are commonly associated with bovine mastitis:

Staphylococci (including beta-lactamase producing strains).

Streptococci (including S. agalactiae, S. dysgalactiae and S. uberis).

A. pyogenes and other minor members of the Corynebacteria spp.

Escherichia coli (including beta-lactamase producing strains).

In addition, it is active in vitro against many less common udder pathogens including: Bacillus cereus, Bacteroides (including beta-lactamase producing strains), Campylobacter spp., Klebsiellae and Pasteurellae.

Clinically, Nisamox Lactating Cow has been shown to be an effective, routine treatment for mastitis in lactating cows. Cases responding successfully to treatment include infections with the following major pathogens:

Staphylococci (including beta-lactamase producing strains).

Streptococci (including S. agalactiae, S. dysgalactiae and S. uberis). Escherichia coli (including beta-lactamase producing strains).

Dosage and administration

Nisamox Lactating Cow should be administered at a dose rate of 3 syringes per infected quarter with a single syringe given every 12 hours. Use each syringe only once. After milking, clean and disinfect the teat end thoroughly with surgical spirit. Insert the syringe nozzle into the teat orifice and apply gentle and continuous pressure until the entire suspension is released. The treated quarter(s) may be milked out at the next normal milking time, but the milk should be discarded.

Contra-indications, warnings, etc

Nisamox Lactating Cow is contra-indicated in known cases of hypersensitivity to penicillins.

Animals must not be slaughtered for human consumption during treatment.

Cattle may be slaughtered for human consumption only after 7 days from the last treatment.

Milk for human consumption must not be taken from a cow during treatment. With cows milked twice daily, milk for human consumption may only be taken from 60 hours (i.e. at the 5th milking) after the last treatment.

With other milking routines, the basis of the veterinary surgeon's advice should be that milk may be taken for human consumption only after the same period from the last treatment (e.g. with three times a day milking and the product

administered twice per day, milk for human consumption may only be taken at the 8th milking). During the course of treatment the situation should be reviewed frequently by close veterinary supervision.

OPERATOR WARNINGS - PENICILLIN/CEPHALOSPORIN SENSITIVITY:

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.

Pharmaceutical precautions

Do not store above 25°C.

Store out of the reach of children.

Syringes are for single use only. Discard any unused material in accordance

with guidance from your local waste regulation authority. e.g. the local regional office of the Environment Agency or SEPA.

Legal category

POM-V

Packaging Quantities

Supplied in a low-density polyethylene syringe with cap, delivering 3g of product. 24 x 3g

Further information

Resistance to many antibiotics is caused by bacterial beta-lactamase enzymes which destroy the antibiotic before it can act. The clavulanic acid in Nisamox Lactating Cow 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 udder.

Nisamox Lactating Cow is effective against Klebsiella infections found in veterinary practice, but it is not indicated for cases involving Pseudomonas species.

Marketing authorisation number

Vm 02000/4232.