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

Land: Irland

Sprache: Englisch

Quelle: HPRA (Health Products Regulatory Authority)

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Fachinformation Fachinformation (SPC)
20-02-2021
DSU DSU (DSU)
25-10-2023

Wirkstoff:

Oxytetracycline dihydrate

Verfügbar ab:

Bimeda Animal Health Limited

ATC-Code:

QJ01AA06

INN (Internationale Bezeichnung):

Oxytetracycline dihydrate

Dosierung:

200 milligram(s)/millilitre

Darreichungsform:

Solution for injection

Verschreibungstyp:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapiebereich:

oxytetracycline

Berechtigungsstatus:

Authorised

Berechtigungsdatum:

2016-02-05

Fachinformation

                                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
                                
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