AVELON TABLET

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

Bayer (Pty) Ltd û Isando

Dosage:

See ingredients

Pharmaceutical form:

TABLET

Composition:

EACH TABLET CONTAINS

Authorization status:

Registered

Authorization date:

2002-08-02

Patient Information leaflet

1
PATIENT INFORMATION LEAFLET
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.

KEEP THIS LEAFLET. YOU MAY NEED TO READ IT AGAIN.

IF YOU HAVE FURTHER QUESTIONS, PLEASE ASK YOUR DOCTOR OR PHARMACIST.

THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU PERSONALLY AND YOU SHOULD
NOT
SHARE YOUR MEDICINE WITH OTHER PEOPLE. IT MAY HARM THEM, EVEN IF THEIR
SYMPTOMS ARE THE SAME AS YOURS.
SCHEDULING STATUS:
S4
PROPRIETARY NAME AND DOSAGE FORM:
AVELON Tablets
AVELON IV Solution for Infusion
WHAT AVELON CONTAINS:
Avelon film coated tablet contains 400mg moxifloxacin, the active
ingredient.
A
single
sterile
unit
of
Avelon
IV
250ml
infusion
solution
contains
400
mg
moxifloxacin.
Other ingredients are:
_TABLETS: _
Croscarmellose sodium, lactose monohydrate, magnesium stearate,
microcrystalline
cellulose, ferric oxide, hypromellose, macrogol 4000, titanium
dioxide.
_SOLUTION FOR INFUSION: _
Sodium chloride, hydrochloric acid 1N, sodium hydroxide solution 2N,
water for
injection.
WHAT AVELON IS USED FOR?
-
Acute Bacterial Sinusitis _ _
-
Acute Bacterial Exacerbation of Chronic Bronchitis _ _
-
Community Acquired Pneumonia
-
Uncomplicated Skin and soft tissue infections
-
Complicated
Skin
and
skin
structure
infections
(including
diabetic
foot
infections)
-
Uncomplicated pelvic inflammatory disease (i.e. infections of female
upper
genital tract, including salpingitis and endometritis)
-
Complicated intra-abdominal infections including polymicrobial
infections such
as abscesses
BEFORE YOU TAKE AVELON:
If you are taking medicines on a regular basis, using this medicine at
the same time
with another medicine may cause undesirable interactions. Please
consult your
doctor, pharmacist or other health care professional for advice.
YOU SHOULD NOT TAKE AVELON IF YOU ARE PREGNANT.
YOU SHOULD NOT BREASTFEED.
2
DO NOT TAKE AVELON:

If you are allergic to moxifloxacin or any of the other ingredients
listed above.

If you have severe liver disease.

If you are pregnant or breastfeeding.
If you are taking othe

Summary of Product characteristics

1
SCHEDULING STATUS:
S4
PROPRIETARY NAME
AVELON TABLETS
AND DOSAGE FORM:
AVELON IV SOLUTION FOR INFUSION
COMPOSITION:
AVELON film coated tablet contains moxifloxacin hydrochloride
equivalent to 400 mg moxifloxacin.
A
single sterile unit
of
AVELON
IV
250
ml infusion
solution contains
moxifloxacin
hydrochloride
equivalent to 400 mg moxifloxacin.
PHARMACOLOGICAL CLASSIFICATION:
A. 20.1.1 Broad and medium spectrum antibiotic
PHARMACOLOGICAL ACTION:
Moxifloxacin is a fluoroquinolone antibacterial with a broad spectrum
of bactericidal action.
Moxifloxacin has been shown to be active against most of the following
microorganisms _in vitro. In-vitro _
sensitivity may not always have been confirmed in clinical infection
(see INDICATIONS).
MICROBIOLOGY
Moxifloxacin
has
_in _
_vitro_
activity
against
a
wide
range
of
Gram-positive
and
Gram-negative
microorganisms. The bactericidal action of moxifloxacin results from
inhibition of the topoisomerase II
(DNA gyrase) and topoisomerase IV required for bacterial DNA
replication, transcription, repair, and
recombination. It appears that the C8-methoxy moiety contributes to
enhanced activity and lower
selection of resistant mutants of Gram-positive bacteria compared to
the C8-H moiety.
The mechanism of action for quinolones, including moxifloxacin, is
different from that of macrolides, beta-
lactams, aminoglycosides, or tetracyclines; therefore, microorganisms
resistant to these classes of drugs
may be susceptible to moxifloxacin and other quinolones. There is no
known cross-resistance between
moxifloxacin and other classes of antimicrobials.
Cross-resistance has been observed between moxifloxacin and other
fluoroquinolones against Gram-
negative bacteria. Gram-positive bacteria resistant to other
fluoroquinolones may, however, still be
susceptible to moxifloxacin.
Moxifloxacin has been shown to be active against most strains of the
following microorganisms, both _in _
_vitro_ and in clinical infections as described in the INDICATIONS AND
DOSAGE section.
AEROBIC GRAM-POSITIVE MICROOR