LEVOFLOXACIN PFIZER
Țară: Irlanda
Limbă: engleză
Sursă: HPRA (Health Products Regulatory Authority)
Caracteristicilor produsului
(SPC)
02-06-2024
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Ingredient activ:
LEVOFLOXACIN HEMIHYDRATE
Disponibil de la:
Pfizer Healthcare Ireland
Dozare:
500 Base Milligrams
Forma farmaceutică:
Film Coated Tablet
Data de autorizare:
2011-09-30
Caracteristicilor produsului
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Levofloxacin Pfizer 500 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet of contains levofloxacin hemihydrate equivalent to 500 mg levofloxacin.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Pink coloured capsule shaped, biconvex film-coated tablets debossed with ‘1’ and ‘4’ on either side of score line on one
side and ‘T’ on the other side. The tablet can be divided into equal halves.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
In adults with infections of mild or moderate severity, levofloxacin is indicated for the treatment of the following
infections when due to levofloxacin-susceptible microorganisms:
- Acute bacterial sinusitis (adequately diagnosed according to national and/or local guidelines on the treatment of
respiratory tract infections, and when it is considered inappropriate to use antibacterial agents that are commonly
recommended for the initial treatment of this infection or when these have failed to resolve the infection)
- Acute bacterial exacerbations of chronic bronchitis (adequately diagnosed according to national and/or local
guidelines on the treatment of respiratory tract infections, and when it is considered inappropriate to use antibacterial
agents that are commonly recommended for the initial treatment of this infection or when these have failed to resolve
the infection)
- Community-acquired pneumonia (when it is considered inappropriate to use antibacterial agents that are commonly
recommended for the initial treatment of this infection)
- Complicated urinary tract infections including pyelonephritis
- Chronic bacterial prostatitis.
- Skin and soft tissue infections.
Consideration should be
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