Avelox

البلد: أرمينيا

اللغة: الإنجليزية

المصدر: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

العنصر النشط:

moxifloxacin

متاح من:

Bayer Pharma AG

INN (الاسم الدولي):

moxifloxacin

جرعة:

400mg

الشكل الصيدلاني:

tablets coated

نوع الوصفة الطبية :

Prescription

خصائص المنتج

SUMMARY OF PRODUCT CHARACTERISTICS
Bayer cross
Avelox ® 400 mgcoated tablets
1.
NAME OF THE MEDICINAL PRODUCT
Avelox 400 mg coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1coated 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). 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 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 coated tablets may also be used to complete a course of
therapy in patients who
have shown improvement during initial treatment with intravenous
moxifloxacin for the
following indications:
- Commun