Tetracure 200 mg/ml solution for injection for cattle, sheep and pigs

البلد: أيرلندا

اللغة: الإنجليزية

المصدر: HPRA (Health Products Regulatory Authority)

العنصر النشط:

Oxytetracycline dihydrate

متاح من:

Bimeda Animal Health Limited

ATC رمز:

QJ01AA06

INN (الاسم الدولي):

Oxytetracycline dihydrate

جرعة:

200 milligram(s)/millilitre

الشكل الصيدلاني:

Solution for injection

نوع الوصفة الطبية :

POM: Prescription Only Medicine as defined in relevant national legislation

المجال العلاجي:

oxytetracycline

الوضع إذن:

Authorised

تاريخ الترخيص:

2016-02-05

خصائص المنتج

Health Products Regulatory Authority
19 February 2021
CRN009SZR
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Tetracure 200 mg/ml solution for injection for cattle, sheep and pigs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
ONE ML CONTAINS:
Oxytetracycline (as dihydrate) 200.0 mg
(Equivalent to 216 mg oxytetracycline dihydrate)
EXCIPIENT:
Sodium Formaldehyde Sulphoxylate Dihydrate 4.0 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
A clear amber solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle, sheep and pigs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment of infections caused by oxytetracycline susceptible bacteria
in cattle, sheep and pigs as follows:
Cattle:

Pasteurellosis and respiratory tract infections caused by _Mannheimia
haemolytica_ or _Pasteurella multocida_.

Umbilical infections and septic arthritis caused by _Trueperella
pyogenes_, _Escherichia coli_ or _Staphylococcus aureus_.

Clinical Mastitis caused by _Trueperella pyogenes_, _Escherichia
coli_, _Staphylococcus aureus, Streptococcus agalactiae_ or
_Streptococcus uberis_.

Metritis caused by _Escherichia coli _
Sheep:

Pasteurellosis and respiratory tract infections caused by _Mannheimia
haemolytica_ or _Pasteurella multocida_.

Umbilical infections and septic arthritis caused by _Trueperella
pyogenes_- or _Escherichia coli_.

Clinical Mastitis caused by _Trueperella pyogenes_, _Escherichia coli_
or _Staphylococcus aureus._

Erysipelas caused by _Erysipelothrix rhusiopathiae_.

The product can also be used for treatment and metaphylaxis of
enzootic abortion in sheep caused by
_Chlamydophila abortus_. The presence of the disease in the group must
be established before the product is used.
Pigs:

Pasteurellosis and respiratory tract infections caused by _Mannheimia
haemolytica_ or _Pasteurella multocida_.

Umbilical infections and septic arthritis caused by _Trueperella
pyogene