Colfen 200 sp, 200 mg/g granules for use in drinki
Land: Irland
Språk: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
Preparatomtale
(SPC)
06-06-2024
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Aktiv ingrediens:
florfenicol
Tilgjengelig fra:
Zoetis Ireland Limited
ATC-kode:
QJ01BA90
Dosering :
200 Mg/Ml
Legemiddelform:
Granules for use in drinking water
Terapeutisk gruppe:
Porcine
Terapeutisk område:
Antibiotics
Autorisasjon status:
Authorised
Preparatomtale
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
COLFEN 200 SP, 200 mg/g granules for use in drinking water for pigs.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
3 PHARMACEUTICAL FORM
Granules for use in drinking water.
White to cream waxy granules.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Pigs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of swine respiratory disease associated with _Pasteurella multocida _susceptible to florfenicol.
4.3 CONTRAINDICATIONS
Do not administer to boars intended for breeding purposes.
Do not administer in cases of previous allergic reactions to florfenicol or any of the excipients.
Do not use in piglets less than 6 weeks old.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
If there is no significant improvement after 3 days of treatment, the diagnosis should be reviewed and if necessary the
treatment should be changed_._
Each g contains:
ACTIVE SUBSTANCE:
Florfenicol
200.0 mg
EXCIPIENT(S):
Butylhydroxytoluene (E321)
1.0
mg
For a full list of excipients, see section 6.1
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 19/07/2013_
_CRN 7012445_
_page number: 1_
4.5 SPECIAL PRECAUTIONS FOR USE
i)
Special precautions for use in animals
The veterinary medicinal product should be used in conjunction with susceptibility testing. Official, national and
regional antimicrobial policies should be taken into account when the product is used.
Inappropriate use of the veterinary medicinal product may increase the prevalence of bacteria resistant to florfenicol.
Treatment should not exceed 5 days.
ii)
Special precautions for the person administering the veterinary medicinal product to animals
Avoid skin and eye contact with product.
Do
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