FENFLOR 300 MG/ML SOLUTION FOR INJECTION FOR PIGS
Țară: Irlanda
Limbă: engleză
Sursă: HPRA (Health Products Regulatory Authority)
Caracteristicilor produsului
(SPC)
29-04-2024
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Ingredient activ:
FLORFENICOL
Disponibil de la:
Krka, d.d., Novo mesto
Codul ATC:
QJ01BA90
INN (nume internaţional):
FLORFENICOL
Dozare:
300 Mg/Ml
Forma farmaceutică:
Solution for Injection
Tip de prescriptie medicala:
POM
Grupul Terapeutică:
Porcine
Zonă Terapeutică:
Florfenicol
Indicații terapeutice:
Antibacterial
Statutul autorizaţiei:
Authorised
Data de autorizare:
2010-06-04
Caracteristicilor produsului
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Fenflor 300 mg/ml solution for injection for pigs.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Florfenicol…………300 mg
EXCIPIENTS:
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
A light yellow to yellow, clear, viscous liquid.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Pigs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment of acute outbreaks of respiratory disease caused by strains of _Actinobacillus pleuropneumoniae _and
_Pasteurella multocida _susceptible to florfenicol.
4.3 CONTRAINDICATIONS
Do not administer to boars intended for breeding.
Do not use in case of hypersensitivity to the active substance or to any of the excipients.
Do not use in the cases of known resistance to the active substance.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 15/03/2013_
_CRN 7013785_
_page number: 1_
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Wipe the stopper before removing each dose. Use a dry, sterile syringe and needle.
Do not use in piglets of less than 2 kg.
The product should be used in conjunction with susceptibility testing and take into account official and local
antimicrobial policies.
Use a suitable draw-off needle or automatic dosing syringe to avoid excessive puncturing of the closure.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY MEDICINAL PRODUCT TO ANIMALS
Care should be taken to avoid accidental self-injection.
In the case of self-injection, seek medical advice and show the label to the doctor.
Do not use
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