Tylovet 20% w/v Solution for injection for cattle and pigs

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Tylosin

Available from:

Eurovet Animal Health B.V.

ATC code:

QJ01FA90

INN (International Name):

Tylosin

Dosage:

20 percent weight/volume

Pharmaceutical form:

Solution for injection

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Cattle, Pigs

Therapeutic area:

tylosin

Therapeutic indications:

Antibacterial

Authorization status:

Authorised

Authorization date:

1988-10-01

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Tylovet 20% w/v Solution for injection for cattle and pigs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml solution for injections contains:
Active substance:
Tylosin (as tylosin tartrate)
200 mg
Excipients:
Benzyl alcohol
40 mg
For the full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
A clear yellow solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle and pigs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of infections caused by microorganisms susceptible
to tylosin. The spectrum of antimicrobial activity
of tylosin includes:_ Staphylococcus_ spp.;_ Streptococcus_ spp.;_
Corynebacterium_ spp.:_ Neisseria_ spp.;_ Flavobacterium_
spp.;_ Campylobacter_ spp.;_ Bacillus anthracis; Moraxella bovis;
Clostridium_ spp.;_ Haemophilus_ spp.;_ Bordetella_
_bronchiseptica; Spirochaetes_;_ Bacteroides_ spp.;_ Mycoplasma_ spp.
4.3 CONTRAINDICATIONS
Do not use in cases of hypersensitivity to the active substance, to
any other macrolide antibiotics or to any of the
excipients.
Do not use in new-born animals.
Do not use in equine species.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
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4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
This prod