Framomycin 150 mg/ml Solution for Injection

Land: Storbritannien

Språk: engelska

Källa: VMD (Veterinary Medicines Directorate)

Aktiva substanser:

Framycetin Sulphate

Tillgänglig från:

Elanco Europe Ltd

ATC-kod:

QJ01GB91

INN (International namn):

Framycetin Sulphate

Läkemedelsform:

Solution for injection

Receptbelagda typ:

POM-V - Prescription Only Medicine – Veterinarian

Terapeutisk grupp:

Cattle

Terapiområde:

Antimicrobial

Bemyndigande status:

Expired

Tillstånd datum:

1994-10-25

Produktens egenskaper

Revised: March 2016
AN: 01695/2015
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Framomycin 150 mg/ml Solution for Injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ML CONTAINS:
ACTIVE SUBSTANCE:
Framycetin sulphate
150 mg (90,000 IU)
EXCIPIENTS:
Chlorocresol
1 mg
Sodium metabisulphite (E223)
2 mg
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear, pale yellow solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dairy cows.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For use as an adjunct to intramammary therapy in the treatment of
acute
bacterial mastitis with systemic involvement, caused by organisms
sensitive to
framycetin in dairy cows. In vitro, framycetin has shown activity
against
Escherichia coli, Staphylococcus aureus, Arcanobacterium pyogenes and
Klebsiella spp.
4.3
CONTRAINDICATIONS
Do not administer by the intravenous route, for intramuscular use
only. Do not
administer to animals known to be allergic to framycetin or other
Streptomyces
produced aminoglycosides, (e.g. streptomycin, gentamicin, kanamycin or
neomycin). Hypersensitivity to framycetin may lead to cross reactions
to other
Streptomyces-produced aminoglycosides and vice versa.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None known.
Revised: March 2016
AN: 01695/2015
Page 2 of 4
4.5
SPECIAL PRECAUTIONS FOR USE
i.
Special precautions for use in animals
The aminoglycosides can cause a fall in serum calcium levels: the
concomitant use of calcium borogluconate infusions at the time of
parturition may be advisable.
Patients’ water intake should not be restricted during treatment.
ii.
Special precautions to be taken by the person administering the
medicinal product to the animals
Avoid the introduction of contamination during use. Should any
apparent
growth or discolouration occur, the product should be discarded.
Care should be taken to avoid accidental self injection.
If irritation occurs, seek medical attention, showing the product