Trimediazine Plain Oral Powder

البلد: أيرلندا

اللغة: الإنجليزية

المصدر: HPRA (Health Products Regulatory Authority)

العنصر النشط:

Trimethoprim; Sulfadiazine

متاح من:

Vetoquinol Ireland Limited

ATC رمز:

QJ01EW10

INN (الاسم الدولي):

Trimethoprim; Sulfadiazine

جرعة:

5.0 / 25.0 percent weight/weight

الشكل الصيدلاني:

Oral powder

نوع الوصفة الطبية :

POM: Prescription Only Medicine as defined in relevant national legislation

المجال العلاجي:

sulfadiazine and trimethoprim

الوضع إذن:

Authorised

تاريخ الترخيص:

1988-10-01

خصائص المنتج

Health Products Regulatory Authority
28 August 2019
CRN00987J
Page 1 of 3
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Trimediazine Plain Oral Powder
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCES
Trimethoprim
5
% w/w
Sulfadiazine
25.0
% w/w
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Oral powder
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Horses.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Trimediazine Plain is indicated for use in the treatment of bacterial
diseases in horses, including upper and lower respiratory
tract infections, alimentary tract infections and infected wounds.
4.3 CONTRAINDICATIONS
Do not use in horses with severe liver parenchymal damage or kidney
damage or known sulphonamide sensitivity, or horses
with blood dyscrasias or cardiac arrhythmias. Do not exceed 7 days
continuous treatment
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
The use of Trimediazine Plain in horses under 1 year old should be
avoided.
4.5 SPECIAL PRECAUTIONS FOR USE
(I) SPECIAL PRECAUTIONS FOR USE IN ANIMALS
To avoid possible crystalluria, adequate water intake is essential.
(II) SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
VETERINARY MEDICINAL PRODUCT TO ANIMALS
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 to EN149 or a
non-disposable respirator to European Standard to 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 fo