Unisol 2.5% w/v Oral Solution for Calves

Country: Միացյալ Թագավորություն

language: անգլերեն

source: VMD (Veterinary Medicines Directorate)

active_ingredient:

Enrofloxacin

MAH:

UNIVERSAL FARMA, S.L

ATC_code:

QJ01MA90

INN:

Enrofloxacin

authorization_status:

Expired

SPC

Revised: January 2011
AN: 01275/2010
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
UNISOL 2.5% oral solution for calves [IE]
UNISOL 2.5% w/v oral solution for calves [UK]
UNISOL 25 mg/ml oral solution for calves [ES, DE, PL]
LANFLOX 2.5 % oral solution for calves [FR, NL, HU, RO, SK]
LANFLOX 25 mg/ml oral solution for calves [CZ]
DORAFLOX 25 mg/ml oral solution for calves [BE]
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Enrofloxacin...................................25.0
mg
EXCIPIENTS:
Benzyl Alcohol (E 1519)................14.0
mg
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral solution
Ready to use aqueous clear, oral solution.
4.
CLINICAL PARTICULARS
4.1.
TARGET SPECIES
Pre-ruminant calves
4.2.
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
In calves:
-
treatment of respiratory infections due to _Pasteurella multocida_
and
_Manheimia haemolytica._
-
treatment of gastro-intestinal infection due to _Escherichia coli_.
To be used where clinical experience and/or sensitivity testing
indicates
enrofloxacin as the drug of choice.
4.3.
CONTRAINDICATIONS
Do not use in cases of confirmed, or suspected, resistance to
quinolones.
Do not use in cases of hypersensitivity to the active substance.
Page 1 of 6
Revised: January 2011
AN: 01275/2010
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.
4.4.
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None
4.5.
SPECIAL PRECAUTIONS FOR USE
i.
Special precautions for use in animals
Do not use for prophylaxis.
During the period of rapid growth, enrofloxacin may affect articular
cartilage.
Official and local antimicrobial policies should be taken into account
when the product is used.
Fluoroquinolones should be reserved for the treatment of clinical
conditions which have responded poorly, or are expected to respond
poorly, to other classes of antimicrobials.
Where