NAM PHUC THINH TRADING CO., LTD

TRIMETHOSULFA ORALE 

Compositions:
1 ml of product contains: Sulfadiazine 200 mg, Trimethoprim 40 mg; Excipients: Sodium formaldehyde sulfoxylate, other excipients qs 1 ml

Pharmaceutical form: Oral solution                                       

Target species: calves, piglets, rabbits, broiler chickens and turkeys.

Indications:  Treatment of primary or secondary bacterial infections to viral infections, septicaemic or localised, affecting the respiratory, digestive, genitalurinary, cutaneous, motor apparatus and in the coccidiosis.

Contraindications:  Do not administer to animals with hypersensitivity to sulphonamides or to any of the excipients. Do not use in case of infection by germs resistant to sulphonamides. Do not administer to animals with impaired liver, kidney functions or blood disorders. Do not administer to animals producing eggs for human consumption.

Adverse reactions: There are known cases of crystalluria, hematuria, chronic toxicities such as thrombocytopenia and leukopenia. Prolonged oral administration may lead to loss of appetite, K vitamin deficiencies, changes in the digestion of cellulose and fermentation of carbohydrates. If any serious effects or other effects not listed in this label are noticed, please inform the veterinarian responsible.

Dosage, route and method of administration:

General dose: 200 mg sulfadiazine and 40 mg trimethoprim per 10 kg body weight, equal to 1 ml of product per 10 kg body weight.
- Calves, piglets and rabbits: 1 ml of product per 10 kg body weight administered directly or diluted in drinking water.
- Broiler chickens and turkeys: 4 ml of product per 8-10 liters of drinking water.
Treatment period: 5 days
Withdrawal periods: Meat and entrails: calves 9 days; piglets 3 days; rabbits 15 days; broiler chickens 3 days; turkeys 7 days. Do not administer to animals producing eggs for human consumption.

Special storage conditions: This veterinary medicinal product does not require any special storage conditions. Keep away from children.
Shelf-life: 36 months

Shelf-life after first opening of the immediate packaging: 15 days
Shelf-life after dilution or reconstitution: 12 hours.

Special warnings:

Special warnings for each target species: Do not administer to animals with functioning rumen and egg-laying hens. Do not administer to lactating animals. For animals with reduced intake of water, run the parenteral treatment, using a suitable injectable product on the advice of the veterinarian. The repeated or
prolonged use should be avoided, improving management practices by cleaning and disinfection. The product in poultry should be used according to EC Regulation 1177/2006 of the Commission and national laws.

Special precautions for use
Special precautions for use in animals: The use of the product should be based on susceptibility testing of bacteria isolated from animals. If this is not possible, therapy should be based on local (regional, farm) epidemiological information. The misuse of the product may increase the prevalence of bacteria resistant to
potentiated sulphonamides and may decrease the effectiveness of treatment with other classes of antimicrobials, due to possible cross-resistance.
Special precautions to be taken by the person administering the medicinal product to animals: It is good practice to avoid direct contact of the products with skin and eyes and inhalation during handling; so
it is recommended to use a special protective equipment consisting of protective clothing, gloves and mask. In case of accidental contact, wash thoroughly with soap and water. Do not eat, drink or smoke while handling. Wash hands after use. People with known hypersensitivity to the active ingredients should avoid contact with the medicine. Do not swallow; in case of accidental ingestion seek medical advice immediately and show the package leaflet or the label to the physician.
Use during pregnancy, lactation or lay: The product should not be used during lactation. Use in pregnancy is permitted only on assessment of risk/benefit ratio by the veterinarian in charge, as despite having no teratogenic effects being noted for the association sulphonamide/trimethoprim at doses recommended; at higher doses trimethoprim seems to have teratogenic effect. Do not administer to animals producing eggs for human consumption.
Interactions with other veterinary medicinal products and other forms of interaction: Avoid concomitant use with other medicinal products with high binding affinity to plasma proteins.
Overdose (symptoms, emergency procedures, antidotes): Doses of up to 10 times those recommended are generally tolerated. In case of toxic effects, medication with folic acid and the provision of drinking water ad libitum represent the recommended emergency procedure.

Incompatibilities: The product should not be administered in acidified drinking water.

SPECIAL PRECAUTIONS TO TAKE WHEN DISPOSING OF UNUSED MEDICINAL OR WASTE PRODUCTS: All unused medicinal products or waste produced by the latter must be disposed of in accordance with local laws and handed over to the responsible waste collection centers for unused or expired medicinal products.

Presentations: bottles of 1L, 5L and 10L

FOR VETERINARY USE ONLY

Keep out of the reach of children

Industria Italiana Integratori TREI S.p.A

42010 Rio Saliceto (RE) Italy - Via Affarosa, 4