Framomycin 15% solution for injection
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
11-05-2024
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Active ingredient:
framycetin sulfate
Available from:
Novartis Animal Health UK Ltd
ATC code:
QJ01GB
Dosage:
15 Per Cent
Pharmaceutical form:
Solution for Injection
Therapeutic group:
Bovine
Therapeutic area:
Antibacterial
Authorization status:
Authorised
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Framomycin 15% Solution for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE
Framycetin Sulphate
90,000 IU
Excipients
Chlorocresol
1 mg
Sodium metabisulphite (E223)
2 mg
For a full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection. Clear pale yellow to light brown solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dairy cattle.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
As an adjunct to the treatment of acute bacterial mastitis with systemic involvement in dairy cows caused by organisms
sensitive to framycetin. In vitro, framycetin has shown activity against _E.coli_, _Staph. aureus_, _Arcanobacterium pyogenes_
and _Klebsiella _spp. Parenteral framycetin injections should be given in conjunction with an appropriate intramammary
preparation.
4.3 CONTRAINDICATIONS
Do not administer by the intravenous route.
Do not administer to animals known to be allergic to framycetin or other Streptomyces produced aminoglycosides (e.g.
neomycin, kanamycin).
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
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.
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 18/08/2014_
_CRN 7018506_
_page number: 1_
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Framycetin can be nephrotoxic and ototoxic when administered in overdose. Do not exceed the stated dose. The drug is
excreted in the urine and should, therefore, be used with caution in animals with compromised renal function. Animals'
wa
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