BIOFLOXCIN Film Coated Tablet 750 Milligram
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
24-03-2023
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Active ingredient:
CIPROFLOXACIN HYDROCHLORIDE
Available from:
Niche Generics Limited
Dosage:
750 Milligram
Pharmaceutical form:
Film Coated Tablet
Authorization date:
2005-10-07
Summary of Product characteristics
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Summary of Product Characteristics
1 NAME OF THE MEDICINAL PRODUCT
BioFloxcin 750 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains ciprofloxacin hydrochloride equivalent to 750mg ciprofloxacin.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
Oval, white film-coated tablet with a scoreline on both sides.
The tablet can be divided into equal halves.
4 CLINICAL PARTICULARS
4.1 Therapeutic Indications
Ciprofloxacin is a synthetic, 4-quinolone derivative with bactericidal activity against a wide range of Gram-negative
and Gram-positive organisms.
Ciprofloxacin is indicated for the treatment of single infections or mixed infections caused by two or more susceptible
organisms. It may be used for infections caused by organisms resistant to other antibiotics, including aminoglycosides,
penicillins and cephalosporins.
The extensive tissue penetration of ciprofloxacin combined with its enhanced antibacterial activity (including
antipseudomonal activity), enables ciprofloxacin to be used alone (pending sensitivity results) or in combination with
an aminoglycoside or with beta-lactam antibiotics, for instance when severe neutropenia is present, or with an antibiotic
active against anaerobes&#
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