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:

200,000 international unit(s)/millilitre

Pharmaceutical form:

Solution for injection

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Cattle, Goats, Pigs, Sheep

Therapeutic area:

tylosin

Therapeutic indications:

Antibacterial

Authorization status:

Authorised

Authorization date:

2013-05-31

Summary of Product characteristics

Health Products Regulatory Authority
27 July 2020
CRN009QQ0
Page 1 of 5
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 by microorganisms susceptible to tylosin.
CATTLE (ADULT):
- Treatment of respiratory infections, metritis caused by
Gram-positive micro-organisms, mastitis caused by _Streptococcus
_spp.,
_Staphylococcus _spp. 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-positive
microorganisms or _Mycoplasma _spp.
4.3 CONTRAINDICATIONS
Do not administer to horses. Intramuscular injection can be fatal in
chickens and turkeys.
Do not use in cases of hypersensitivity to tylosin, other macrolides
or to any of the excipients.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
Health Products Regulatory Authority
27 July 2020
CRN009QQ0
Page 2 of 5
4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Due to likely variability (time, geographical) in susceptibility of
bacteria to tylosin, bacteriological sampling and susceptibility
testing are recommended.
Use of the product deviating from the instructions given in the SPC
may increase the prevalence of bacteria resistant to tylosin
and may decrease the effectiveness of t