ENROTRIL MAX 100 MG/ML SOLUTION FOR INJECTION FOR CATTLE

Nazione: Irlanda

Lingua: inglese

Fonte: HPRA (Health Products Regulatory Authority)

Principio attivo:

ENROFLOXACIN

Commercializzato da:

Norbrook Laboratories Limited

Codice ATC:

QJ01MA90

INN (Nome Internazionale):

ENROFLOXACIN

Dosaggio:

100 Mg/Ml

Forma farmaceutica:

Solution for Injection

Tipo di ricetta:

POM

Gruppo terapeutico:

Bovine

Area terapeutica:

Enrofloxacin

Indicazioni terapeutiche:

Antibacterial

Stato dell'autorizzazione:

Authorised

Data dell'autorizzazione:

2010-09-03

Scheda tecnica

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Enrotril Max 100 mg/ml Solution for Injection for Cattle.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
EACH ML CONTAINS:
ACTIVE SUBSTANCE
Enrofloxacin
100.0 mg
EXCIPIENTS
Benzyl alcohol (E1519)
20.0 mg
Butyl alcohol
30.0 mg
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Solution for injection.
Clear yellow solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Indicated for the treatment of bovine respiratory disease associated with _Mannheimia haemolytica, Pasteurella_
_multocida, Histophilus somni _and _Mycoplasma _spp. where clinical experience, supported where possible by sensitivity
testing of the causal organism, indicates enrofloxacin as the drug of choice.
4.3 CONTRAINDICATIONS
Do not use for prophylaxis
Do not use in case of disturbances in growth of cartilage and/or during injury of locomotory system particularly on
functionally loaded joints or due to body weight loaded joints.
Do not use in cases of resistance against other fluoroquinolones, due to the potential for cross-resistance.
Do not use in cases of known hypersensitivity to the active substance or to any of the excipients.
Do not use in growing horses because of possible deleterious damage on articular cartilage.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None known.
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 11/09/2015_
_CRN 7020157_
_page number: 1_
4.5 SPECIAL PRECAUTIONS FOR USE
(i)
Special precautions for use in animals
Normal sterile precautions should be taken.
Official and local antimicrobial policies should be taken into account when the product is u