TETRACURE 200 MG/ML SOLUTION FOR INJECTION FOR CATTLE, SHEEP AND PIGS

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

OXYTETRACYCLINE (AS OXYTETRACYCLINE DIHYDRATE PH. EUR.)

Available from:

Cross Vetpharm Group Limited

ATC code:

QJ01AA06

INN (International Name):

OXYTETRACYCLINE (AS OXYTETRACYCLINE DIHYDRATE PH. EUR.)

Dosage:

200 Mg/Ml

Pharmaceutical form:

Solution for Injection

Prescription type:

POM

Therapeutic group:

Bovine, Ovine, Porcine

Therapeutic area:

Oxytetracycline

Therapeutic indications:

Antibacterial

Authorization status:

Authorised

Authorization date:

2016-02-05

Summary of Product characteristics

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.
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 05/02/2016_
_CRN 7019536_
_page number: 1_
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
The product is indicated for the 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 cause