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

Available from:

Cross Vetpharm Group Limited

ATC code:

QJ01AA06

INN (International Name):

Oxytetracycline

Dosage:

200 milligram(s)/millilitre

Pharmaceutical form:

Solution for injection

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Cattle, Pigs, Sheep

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.
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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_.
Umbilica