Introduction

vet06001

Company name: Bimeda

Address: A division of Cross Vetpharm Group UK Limited

Bryn Cefni Industrial Park,

Llangefni,

Anglesey LL77 7XA.

Telephone: 0800 526769

Fax: 01248 725416

Email: sales@bimeda.co.uk

Presentation

A clear, sterile aqueous solution for parenteral administration.

Each ml contains 200 mg Sulfadoxine, 40 mg Trimethoprim and Sodium Formaldehyde Sulfoxylate as an antioxidant.

Uses

The in vitro activity covers most common Gram-positive and Gram-negative bacteria including Actinobacillus spp., Actinomyces bovis, Bordetella spp., Corynebacterium spp., Klebsiella spp., Listeria monocytogenes, Nocardia spp., Pasteurella spp., Proteus spp., Salmonella spp., Staphylococcus spp., and Streptococcus spp.

The injection may be used in the treatment of a wide range of diseases and conditions of bacterial origin in cattle and horses.

Respiratory infections of bacterial origin including pneumonia, rhinitis, bronchitis and secondary bacterial infections following viral pneumonia or mycoplasmal infections.

Urogenital tract infections including cystitis, vaginitis, urethritis, nephritis and metritis.

Alimentary tract infections, neonatal diarrhoea, salmonellosis and post weaning enteritis.

Dosage and administration

15 mg/kg (equivalent to 1 ml per 16 kg bodyweight) daily. Daily dosing should be repeated for two days after symptoms have resolved up to a maximum of 5 days.

Cattle: By slow intravenous or intramuscular injection. Intramuscular injection is the preferred route of administration and should be given into the neck.

Horses: By slow intravenous injection.

Contra-indications, warnings, etc

For animal treatment only.

Do not administer by the intraperitoneal or subcutaneous route.

Do not administer to horses exhibiting cardiac arrhythmias. Such arrhythmias may be associated with the administration of certain anaesthetic and sedative agents.

Intravenous injections should be administered slowly over as long a period as is reasonably practical.

Very occasionally, temporary irritating swellings may appear at the site of injection.

Studies during pregnancy have not been conducted. Use with care in pregnant animals.

Do not exceed the recommended dose or treat animals for more than 5 consecutive days.

The following warnings are applicable to all Trimethoprim Sulfonamide combinations for use in the horse.

1.Cardiac and respiratory shocks in horses have been observed, mostly after intravenous injection.

2.The injection solution should be approximately at body temperature. At the first signs of intolerance, the injection should be interrupted and shock treatment initiated. The product should be injected slowly over as long a period as is reasonably practical.

3.The intravenous route of administration is contra-indicated in the case of previous or concurrent administration of central nervous system depressants (e.g. anaesthetics, neuroleptics).

4.The possibility of an anaphylactic or hypersensitivity reaction occurring following administration on rare occasions must be borne in mind.

5.As with all Trimethoprim Sulfonamide formulations the possibility of potential damage to the kidney or liver or haematopoetic system should be considered.

Operator warning:

Operator warning

Care should be taken to avoid accidental injection and contact with the skin. Wash hands after use.

Sulphonamides may cause hypersensitivity (allergy) following injection, inhalation, ingestion or skin contact.

Withdrawal Periods

cattle:

Milk for human consumption must not be taken from cows during treatment. With cows milked twice daily, milk for human consumption may only be taken from 60 hours (i.e.5th milking) from the last treatment. With other milking routines, milk may be taken for human consumption only after the same period from last treatment (e.g. with 3 times a day milking, milk for human consumption may only be taken at the 8th milking).

Animals must not be slaughtered for human consumption during treatment.

Cattle may only be slaughtered for human consumption after 10 days from the last treatment.

horses:

Not to be used in horses intended for human consumption. Treated horses may never be slaughtered for human consumption. The horse must have been declared as not intended for human consumption under national horse passport legislation.