Avelox tablets coated

Kraj: Armenia

Język: angielski

Źródło: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Składnik aktywny:

moxifloxacin

Dostępny od:

Bayer AG

Kod ATC:

J01MA14

INN (International Nazwa):

moxifloxacin

Dawkowanie:

400mg

Forma farmaceutyczna:

tablets coated

Sztuk w opakowaniu:

(5/1x5/) in blister

Typ recepty:

Prescription

Status autoryzacji:

Registered

Data autoryzacji:

2019-03-20

Charakterystyka produktu

1
RESTRICTED
SUMMARY OF PRODUCT CHARACTERISTICS
2
RESTRICTED
1.
NAME OF THE MEDICINAL PRODUCT
Avelox 400 mg coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 coated tablet contains 400 mg moxifloxacin (as hydrochloride).
Excipient with known effect: The coated tablet contains 68 mg lactose
monohydrate (= 66.56 mg lactose)
(see section 4.4).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Coated tablet
Dull red coated tablet with an oblong, convex shape with facet, a
dimension of 17 x 7 mm, and marked with
“M400” on one side and “BAYER” on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Avelox 400 mg 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).
In the following indications, Moxifloxacin should be used only when it
is considered inappropriate to use
other antibacterial agents that are commonly recommended for the
treatment of these infections:
-
Acute bacterial sinusitis
-
Acute exacerbation of chronic obstructive pulmonary disease including
bronchitis
In the following indications, 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:
-
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 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).