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Date: Thursday, May 30, 2024 7:37

Description: Bimeda logo
Release 3.50
Bimamix Oral Suspension for Calves
 
Species: Cattle
Therapeutic indication: Pharmaceuticals: Antimicrobials: Oral preparations: Others
Active ingredient: Neomycin, Sulfadiazine (Sulphadiazine)
Product:Bimamix Oral Suspension for Calves
Product index: Bimamix Oral Suspension for Calves
Cattle - meat: 28 days
Withdrawal notes: Not intended for use in animals producing milk for human consumption
Incorporating:
Qualitative and quantitative composition
Active substances:
Sulfadiazine 150 mg/ml
Neomycin (as neomycin sulphate) 25 mg/ml
Pharmaceutical form
A pale pink, viscous oral suspension.
Clinical particulars
Target species
Pre-ruminant calves.
Indications for use
For the treatment of diarrhoea in pre-ruminant calves associated with infections caused by organisms known to be, or suspected of being, susceptible to the combination of sulfadiazine and neomycin.
Contra-indications
Do not use in animals with known hypersensitivity to the active ingredient.
Do not exceed the recommended dosage or the period of treatment.
Do not use local anaesthetics of the procaine group during treatment as they are antagonistic to the sulphonamide component.
Do not use in calves with a functional rumen.
Do not use in lactating cows.
Do not use in foals and horses.
Special warnings for each target species
Concurrent intravenous fluid therapy should be considered in dehydrated calves. Parenteral antibiotic treatment should be considered if a clinical response is not seen after 48 hours treatment.
Special precautions for use
Special precautions for use in animals
Official, national and regional antimicrobial policies should be taken into account when the product is used.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Care should be taken to avoid contact with the skin. Wash hands after use. Sulphonamides may cause hypersensitivity (allergy) following injection, inhalation, ingestion or skin contact. Hypersensitivity to sulphonamides may lead to cross reaction with other antibiotics. Allergic reaction to these substances may occasionally be serious.
1. Do not handle this product if you know you are sensitive to sulphonamides.
2. If you develop symptoms following exposure such as a skin rash, you should seek medical advice and show the doctor this warning.
Adverse reactions
Chronic usage of oral neomycin may result in bacterial or fungal superinfections.
Use during pregnancy, lactation or lay
The product is intended for use in calves only.
Do not use in lactating cows.
Interactions
There is interaction and antagonism between sulphonamides and the Vitamin B Complex. Do not use local anaesthetics of the procaine group during treatment, as they are antagonistic to the sulphonamide component.
Amounts to be administered and administration route
Shake the bottle well before use.
Administration is by oral drench.
4 ml per 10 kg bodyweight twice daily for a maximum period of 5 days. This equates to 60 mg/kg Sulfadiazine and 10 mg/kg Neomycin twice daily. To ensure correct dosage, body weight should be determined as accurately as possible to avoid underdosing.
Overdose
Good tolerance has been confirmed in calves at x3 and x5 times the recommended dose rate.
Withdrawal periods
Meat & offal: 28 days. Not intended for use in animals producing milk for human consumption.
Pharmacological particulars
Pharmacotherapeutic group: Antidiarrheals, intestinal anti-inflammatory/anti-infective agents, intestinal anti-infectives, antibiotics.
ATC vet code: QA07AA51
Pharmacodynamic properties
Sulphadiazine is a broad spectrum antimicrobial agent. It acts by interfering with the biosynthesis of folic acid in bacteria cells, competitively preventing para-aminobenzoic acid (PABA) from incorporation into folic acid molecule.
Neomycin is the isomeric mixture of Neomycin Band C. It has a rapid dose related bactericidal action on susceptible microorganisms. The antibacterial action is directed primarily against aerobic gram negative bacteria.
Pharmacokinetic particulars
Sulfadiazine is rapidly absorbed from the gastrointestinal tract and widely distributed to all tissues and body fluids. The sulphonamides are eliminated by a combination of renal excretion and biotransformation.
Neomycin is poorly absorbed from the gastrointestinal tract, has a short half-life and is nearly all excreted unchanged from the gastrointestinal tract.
Pharmaceutical particulars
Excipients
Methyl parahydroxybenzoate, Propyl parahydroxybenzoate, Carmoisine E122, Light Kaolin, Citric Acid Anhydrous, Sodium Citrate, Xanthan Gum, Povidone 90, Propylene Glycol, Polysorbate 20, Simethicone Emulsion, Water Purified.
Major incompatibilities
There is interaction and antagonism between sulphonamides and the Vitamin B Complex. Do not use local anaesthetics of the procaine group during treatment, as they are antagonistic to the sulphonamide component.
Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 18 months. Shelf life after first opening the immediate packaging: 28 days
Special precautions for storage
Do not store above 25°C.
Immediate packaging
250 ml and 1 litre white, high density polyethylene bottles. The closure is a tamper evident cap composed of a polypropylene copolymer. A 50ml dosing syringe is supplied with the 250ml presentation only. Not all pack sizes may be marketed.
Disposal
Any unused product or waste materials should be disposed of in accordance with national requirements.
Marketing Authorisation Number
Vm 50146/ 4022
Significant changes
Date of the first authorisation or date of renewal
12th June 2007
Date of revision of the text
October 2018
Any other information
Nil
Legal category
Legal category: POM-V
GTIN
GTIN description:Bimamix 1L
GTIN:5391510230977
GTIN description:Bimamix 250ML
GTIN:5391510230960