Avelox Infusion Solution 400mg250mL

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

MOXIFLOXACIN HCL

Available from:

BAYER CO. (MALAYSIA) SDN. BHD.

INN (International Name):

MOXIFLOXACIN HCL

Units in package:

250 ml 0 mL

Manufactured by:

Fresenius Kabi Italia S.r.l

Summary of Product characteristics

Reference : Moxifloxacin/ Film-coated Tablets / Solution for Infusion
/ CCDS / Version 23 /January 2021
AVELOX ®
NAME OF THE MEDICINAL PRODUCT
Avelox 400 mg film-coated tablets
Avelox 400 mg/250mL solution for infusion
QUALITATIVE AND QUANTITATIVE COMPOSITION
Film-coated tablet
1 film-coated tablet contains 400 mg moxifloxacin (as hydrochloride).
Solution for infusion
1 bottle or bag contains 250 mL solution for infusion containing 400
mg moxifloxacin
(as hydrochloride).
PHARMACEUTICAL FORM
Film-coated tablet
Dull red film-coated tablet with an oblong, convex shape with facet, a
dimension of 17x7
mm with 10 mm radius of curvature and a weight of
693.8-699.8mg.“Bayer”on one side
and “M 400” on the other side.
Dull red film-coated tablet with an oblong, convex shape with facet, a
dimension of 17x7
mm with 10 mm radius of curvature and a weight of
693.8-699.8mg.“blanc”on one side
and “M 400” on the other side.
Solution for infusion
250 mL polyolefine flexible bag filled with minimum 250 mL clear,
yellow solution.
250 mL glass bottle with clear, yellow solution filled with minimum
250 mL.
INDICATIONS
Avelox tablets are indicated for the treatment of adults (> 18 years
of age) with the
following bacterial infections caused by susceptible strains:
•
Acute sinusitis
•
Acute exacerbations of chronic bronchitis
_ _
•
Community acquired pneumonia
•
Mild to moderately severe inflammatory pelvic diseases (i.e.
Infections of the
upper female genital tract, including salpingitis and endometritis),
without an
associated tubo-ovarian or pelvic abscess.
Avelox 400 mg film-coated tablets are not recommended for monotherapy
of mild
to moderately severe inflammatory pelvic diseases. Preferably, they
should be
administered in combination with another suited antibiotic (such as
cephalosporin), due to the increasing resistance of
_Neisseria gonorrhoeae_
to
Reference : Moxifloxacin/ Film-coated Tablets / Solution for Infusion
/ CCDS / Version 23 /January 2021
moxifloxacin; that is, unless moxifloxacin-resistant