AVELOX 400 Milligram Film Coated Tablet
Country: Írland
Tungumál: enska
Heimild: HPRA (Health Products Regulatory Authority)
Vara einkenni
(SPC)
19-04-2024
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Virkt innihaldsefni:
MOXIFLOXACIN
Fáanlegur frá:
LTT Pharma Limited
INN (Alþjóðlegt nafn):
MOXIFLOXACIN
Skammtar:
400 Milligram
Lyfjaform:
Film Coated Tablet
Gerð lyfseðils:
Product subject to prescription which may not be renewed (A)
Leyfisstaða:
Withdrawn
Leyfisdagur:
2013-03-05
Vara einkenni
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Avelox 400 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One film-coated tablet contains 400 mg moxifloxacin (as hydrochloride).
Excipient with known effect: The film-coated tablet contains lactose monohydrate (see section 4.4).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
_Product imported from the UK:_
Dull red tablets marked with “M400” on one side and “BAYER” on the reverse.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Avelox 400 mg film-coated tablets are indicated for the treatment of the following bacterial infections in patients of
18 years and older caused by bacteria susceptible to moxifloxacin (see sections 4.4, 4.8 and 5.1). Moxifloxacin should
be used only when it is considered inappropriate to use antibacterial agents that are commonly recommended for the
initial treatment of these infections or when these have failed:
-
Acute bacterial sinusitis (adequately diagnosed)
-
Acute exacerbations of chronic bronchitis (adequately diagnosed)
-
Community acquired pneumonia, except severe cases
-
Mild to moderate pelvic inflammatory disease (i.e. infections of female upper genital tract, including
salpingitis and endometritis), without an associated tubo-ovarian or pelvic abscess.
Avelox 400 mg film-coated tablets are not recommended for use in monotherapy of mild to moderate pelvic
inflammatory disease but should be given in combination with another appropriate antibacterial agent (e.g.
a cephalosporin) due to increasing moxifloxacin resistance of _Neisseria gonorrhoeae _unless moxifloxacin-
resistant _Neisseria gonorrhoeae _can be excluded (see sections 4.4 and 5.1).
Avelox 400 mg film-coated tablets may also be used to complete a course
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