TYLOSIN BIOVET JSC 200 MG/ML SOLUTION FOR INJECTION FOR CATTLE, SHEEP, GOATS AND PIGS

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

TYLOSIN

Available from:

BIOVET Joint Stock Company

ATC code:

QJ01FA90

INN (International Name):

TYLOSIN

Dosage:

200 Mg/Ml

Pharmaceutical form:

Solution for Injection

Prescription type:

POM

Therapeutic group:

Bovine, Caprine, Ovine, Porcine

Therapeutic area:

Tylosin

Therapeutic indications:

Antibacterial

Authorization status:

Authorised

Authorization date:

2013-05-31

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
TYLOSIN BIOVET JSC 200 mg/ml solution for injection for cattle, sheep, goats and pigs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance:
Tylosin
200,000 IU/ml
Excipients:
Benzyl alcohol (E1519)
40 mg/ml.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
A pale yellow to amber-coloured liquid.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle, sheep, goats, pigs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Infections caused my microorganisms susceptible to tylosin.
CATTLE (ADULT):
-
Treatment of respiratory infections, metritis caused by Gram-positive micro-organisms, mastitis caused by
_Streptococcus _spp., _Staphylococcus _spp. or _Mycoplasma _and interdigital necrobacillosis, i.e. panaritum or foot rot.
CALVES:
-
Treatment of respiratory infections and necrobacillosis.
PIGS:
-
Treatment of enzootic pneumonia, haemorrhagic enteritis, erysipelas and metritis.
-
Treatment of arthritis caused by _Mycoplasma _and _Staphylococcus _spp.
SHEEP AND GOATS:
-
Treatment of respiratory infections, metritis caused by Gram-positive microorganisms, mastitis caused by Gram+
microorganisms or _Mycoplasma _spp.
4.3 CONTRAINDICATIONS
Do not administer to horses. Intramuscular injection can be fatal in chickens and turkeys.
Do not administer to animals with a known hypersensitivity to tylosin or other macrolides.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
HEALTH PRODUCTS REGULATORY AUTHORITY
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_Date Printed 08/04/2016_
_CRN 7022886_
_page number: 1_
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Due to likely variability (time, geographical) in susceptibility of bac