NOAH Compendium

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Date: Thursday, July 2, 2020 12:54

Release 3.130
Trimediazine™ BMP Premix for Medicated Feeding Stuff
 
Species: Chickens, Pigs, Turkeys
Therapeutic indication: Medicinal feed additives: Antimicrobials and antimicrobials combination
Active ingredient: Sulfadiazine (Sulphadiazine), Trimethoprim
Product:Trimediazine™ BMP Premix for Medicated Feeding Stuff
Product index: Trimediazine BMP Premix
Pig - meat: 5 days
Poultry - meat: 1 day
Withdrawal notes: Turkeys: 3 days. Do not administer to birds producing eggs intended for human consumption.
Presentation
A granular powder for administration in feed to pigs, chickens and turkeys as a broad spectrum anti-bacterial. Each kg contains Trimethoprim 25 g and Sulfadiazine 125 g.
Uses
Pigs
For the treatment of atrophic rhinitis when associated with Bordetella brochiseptica and streptococcal meningitis caused by Streptococcus suis type II.
Chickens and Turkeys
For use in the treatment of diseases caused by bacteria sensitive to potentiated sulphonamides including Salmonella and Pasteurella.
Dosage and administration
Pigs
Incorporate into finished feed at the following rate according to feed intake and dosage required (combined active ingredients 15 to 30 mg/kg bodyweight).
Administer for 5 days.
Feed intake per day per
kg bodyweight
Inclusion rate kg per tonne of feed
Up to 35 g
2.75–5.5 kg
35–40 g
2.50–5.0 kg
40–45 g
2.25–4.5 kg
45–50 g
2.00–4.0 kg
50–55 g
1.75–3.5 kg
55–65 g
1.50–3.0 kg
Sows
Depending on feed intake; bodyweight and dosage required, incorporate to give a dosage of 15-30mg combined active ingredients per kg bodyweight.
Chickens and Turkeys
Incorporate into finished feed at 2 kgs per tonne and feed for 10 days.
To ensure thorough dispersion, the product should first be mixed with 12.5kg of feed before incorporation in the final mix.
Contra-indications, warnings, etc
Do not administer to animals with known sulphonamide hypersensitivity.
Chickens and Turkeys: where appetite is depressed the inclusion rate should be increased to achieve the correct dosage.
To avoid possible crystalluria, adequate water intake is essential. Particular care is needed with animals suffering from renal damage.
When incorporated at a rate of below 2kg per tonne of animal feed, the product must only be mixed by a manufacturer who is approved to mix at that level.
Hypersensitivity to sulphonamides has been rarely reported, however this remains a potential undesirable effect. Crystalluria caused by precipitation of insoluble sulphonamide is a theoretical risk although rarely reported.
As there is no specific antidote, in case of overdose, treatment should be symptomatic.
Use during pregnancy, lactation or lay
Data on the exact level below which no effects on foetal development were observed are not available. However extensive use of the product in different species over many years, have not shown adverse effects on the foetus.
When administered to lactating females, small amounts of trimethoprim and sulfadiazine are present in the maternal milk. Since no studies have been reported of the effect on the development of new born young of the ingestion of this milk, it would be prudent not to feed very young animals with milk obtained from the mother.
Withdrawal periods
Pigs- Meat: 5 days
Chickens- Meat: 1 day
Turkeys- Meat: 3 days
Do not administer to birds producing eggs intended for human consumption.
Incorporation into the feed must be performed by a suitably approved manufacturer. Persons handling this product should avoid inhalation of any dust and contact with skin. Wear either a disposable half-mask respirator conforming to European Standard EN149 or a non-disposable respirator to European Standard EN140 with filter EN143 when mixing or handling this product. Rubber gloves should be worn when mixing or handling this product. Hands should be washed thoroughly after use. Sulphonamides may cause hypersensitivity (allergy) following injection, inhalation, ingestion or skin contact. Hypersensitivity to sulphonamides may lead to cross reactions with other antibiotics. Allergic reactions 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.
Pharmaceutical precautions
Store away from food, drink and animal feeding stuff.
Do not store above 25°C.
Store in a dry place.
Store out of reach of children.
The product will remain stable in the finished feed for 6 weeks.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Legal category
Legal category: POM-V
Packaging quantities
12kg tri-wall paper sacks.
Further information
ATC Vet code QJ01EW10
Pharmacological Properties
Sulfadiazine is a bacterial antibiotic belonging to the sulphonamide group, which acts by inteference with the synthesis of nucleic acids. Trimethoprim is a dihydrofolate reductase inhibitor which also interferes with the synthesis of bacterial nucleic acids. Sulfadiazine and trimethoprim act on the same metabolic pathway, resulting in potentiation of antibacterial activity.
Following oral administration of sulfadiazine and trimethoprim to chickens, t ½ a and t ½ βvalues of 0.756 and 7.07 hours (sulfadiazine) and 0.680 and 6.24 hours (trimethoprim) were obtained. Values for Tmax were 2.46 and 2.44 hours, values for Cmax were 86.45 and 3.65µg/ml and values of AUC were 620.50 and 19.87 µg hour/ml, respectively for sulfadiazine and trimethoprim.
Marketing Authorisation Number
Vm 08007/4064.
Significant changes
GTIN
GTIN description:Trimediazine BMP 12kg
GTIN:03605874089952