Country: France
Language: English
Source: HMA (Heads of Medicines Agencies)
sulfamethoxazole 100 mg/ml, trimethoprim 20 mg/ml
Eurovet Animal Health
QJ01EW11
Oral solution
Sulfamethoxazole and trimethoprime
Chicken Broilers, Pigs Food
2012-06-20
1/11 PART IB-2A FULL LABEL TEXT 1 LITRE BOTTLE / 5 LITRE CAN METHOXASOL SOLUTION FOR USE IN DRINKING WATER FOR PIGS AND BROILERS NL/V/0166/001/DC. THE FULL TEXT WILL BE PRINTED ON THE BOTTLE/CAN FORMAT USED IS ESPECIALLY FOR THIS TYPE OF LABELLING 2/11 PARTICULARS TO APPEAR ON THE OUTER PACKAGE = IMMEDIATE PACKAGE = LEAFLET 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Methoxasol 20/100 mg/ml solution for use in drinking water for pigs and chickens. _FI/DK: Methoxasol vet 20/100 mg/ml solution for use in drinking water for pigs and chickens. _ Trimethoprim/Sulfamethoxazole 2. STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENT Each ml contains: Active Substance: Trimethoprim Sulfamethoxazole 20 mg 100 mg_ _ 3. PHARMACEUTICAL FORM Clear and yellow solution for use in drinking water 4. PACKAGE SIZE 1 litre _(5 litre)_ 5. TARGET SPECIES Pigs and chickens (broilers). 6. INDICATION(S) Pigs: Treatment and prevention of respiratory infections caused by _Actinobacillus pleuropneumoniae_ susceptible to trimethoprim and sulfamethoxazole where the disease has been diagnosed in the herd. Broilers: Treatment and prevention of respiratory infections caused by _Escherichia coli_ susceptible to trimethoprim and sulfamethoxazole where the disease has been diagnosed in the flock. 7. CONTRAINDICATIONS Do not use in animals suffering from severe liver or kidney disease, oliguria or anuria. Do not use in animals with impaired haematopoietic systems. Do not use in case of known hypersensitivity to sulfonamides or trimethoprim. 8. ADVERSE REACTIONS A diminished w Read the complete document
1/5 SUMMARY OF PRODUCT CHARACTERISTICS METHOXASOL SOLUTION FOR USE IN DRINKING WATER FOR PIGS AND BROILERS NL/V/0166/001/DC. 2/5 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Methoxasol 20/100 mg/ml solution for use in drinking water for pigs and chickens. _FI/DK: Methoxasol vet 20/100 mg/ml solution for use in drinking water for pigs and chickens. _ 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: ACTIVE SUBSTANCES: Trimethoprim 20.0 mg Sulfamethoxazole 100.0 mg EXCIPIENTS For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for use in drinking water. Clear and yellow solution. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Pigs and chickens (broilers). 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Pigs: Treatment and prevention of respiratory infections caused by _Actinobacillus pleuropneumoniae_ susceptible to trimethoprim and sulfamethoxazole where the disease has been diagnosed in the herd. Broilers: Treatment and prevention of respiratory infections caused by _Escherichia coli_ susceptible to trimethoprim and sulfamethoxazole where the disease has been diagnosed in the flock. 4.3 CONTRAINDICATIONS Do not use in animals suffering from severe liver or kidney disease, oliguria or anuria. Do not use in animals with impaired haematopoietic systems. Do not use in case of known hypersensitivity to sulfonamides or trimethoprim. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Severely diseased animals can have a decreased appetite and water consumption. If necessary the concentration of the VMP in the drinking water should be adjus Read the complete document