Tylo 200 mg/ml solution for injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Tylosin tartrate

Available from:

Kela n.v.

ATC code:

QJ01FA90

INN (International Name):

Tylosin tartrate

Dosage:

200 milligram(s)/millilitre

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
Tylo 200 mg/ml solution for injection.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
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
Treatment of infections of the respiratory,
gastrointestinal and urogenital system,
including infections of the skin and
the soft tissues caused by tylosin-sensitive pathogenic germs.
Specific indications for use per species:
Cattle:
Bronchopneumonia
Pasteurellosis
Calf pneumonia (acute)
Footrot
Calf septicemia
Metritis
Swine:
Swine enzootic pneumonia (Mycoplasm infection)
Acute pneumonia
Atrophic rhinitis (_Bordetella bronchiseptica_,_ Mycoplasma suis_,_
Pasteurella, Haemophilus_, complex etiology).
Swine dysenteria (_Treponema hyodysenteriae_)
Erysipelas
4.3 CONTRAINDICATIONS
Do not administer to horses.
ACTIVE SUBSTANCE:
Tylosin base
200
mg/ml
(as Tylosin tartrate)
EXCIPIENTS:
Benzyl alcohol
40.0 mg/ml
For a full list of excipients see section 6.1.
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4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Do not inject more than 10 ml of solution per injection site and use
alternate sites for subsequent injection.
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Use of the