NOROTYL LA 150 MG/ML SUSPENSION FOR INJECTION.

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

TYLOSIN

Available from:

Norbrook Laboratories Limited

ATC code:

QJ01FA90

INN (International Name):

TYLOSIN

Dosage:

150 Mg/Ml

Pharmaceutical form:

Suspension for Injection

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Porcine

Therapeutic area:

tylosin

Therapeutic indications:

Antibacterial

Authorization status:

Authorised

Authorization date:

1999-02-05

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Norotyl LA 150 mg/ml suspension for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Suspension for injection.
An oily cream suspension.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Pigs
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment of swine respiratory disease associated with_ Mycoplasma
hyopneumoniae_ and_ Pasteurella multocida_
sensitive to tylosin.
Because of very high tylosin resistance rates in_ Pasteurella
multocida_, Norotyl LA should only be used after sensitivity
testing of the isolated pathogens involved.
4.3 CONTRAINDICATIONS
Do not inject intravenously and subcutaneously.
Do not use in animals known to be hypersensitive to the active
substance.
Do not use in cases of known tylosin resistance or cross–resistance
(macrolide-lincosamide-streptogramin resistance).
Do not administer to animals with liver dysfunction.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
ACTIVE SUBSTANCE
Tylosin
150
mg
Excipients
q.s. 1 ml
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Use of the product should be based on susceptibility testing and take
into account official and local antimicrobial
policies.
SPECIAL PRECAUTIONS TO