TYLOVET 20% W/V SOLUTION FOR INJECTION FOR CATTLE AND PIGS

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

TYLOSIN (AS TYLOSIN TARTRATE PH. EUR.)

Available from:

Eurovet Animal Health B.V.

ATC code:

QJ01FA90

INN (International Name):

TYLOSIN (AS TYLOSIN TARTRATE PH. EUR.)

Dosage:

20 %w/v

Pharmaceutical form:

Solution for Injection

Prescription type:

POM

Therapeutic group:

Bovine, Porcine

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.
HEALTH PRODUCTS REGULATORY AUTHORITY
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_Date Printed 23/12/2016_
_CRN 7025437_
_page number: 1_
4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
This product contains benzyl alcohol which has been documented to cause adverse reactions in neonates. For this
reason this product should not be used in very young animals.
Use of the product should be based on susceptibility testing of the bacteria isolated from the animal. If this is not
possible, therapy should be base