MEGAXIN TABLETS

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

MOXIFLOXACIN AS HYDROCHLORIDE

متاح من:

BAYER ISRAEL LTD

ATC رمز:

J01MA14

الشكل الصيدلاني:

FILM COATED TABLETS

تركيب:

MOXIFLOXACIN AS HYDROCHLORIDE 0.4 G

طريقة التعاطي:

PER OS

نوع الوصفة الطبية :

Required

المصنعة من قبل:

BAYER AG., GERMANY

المجموعة العلاجية:

MOXIFLOXACIN

المجال العلاجي:

MOXIFLOXACIN

الخصائص العلاجية:

For the treatment of the following bacterial infections in patients of 18 years and older• Respiratory infections : - Uncomplicated Acute bacterial sinusitis (ABS) - Acute exacerbations of chronic bronchitis (AECB) Megaxin tablets should be used to treat adequately diagnosed ABS and AECB 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 to resolve the infection. - Community acquired pneumonia, except severe cases. Megaxin tablets should be used only when it is considered inappropriate to use antibacterial agents that are commonly recommended for the initial treatment of this infection. • Community-acquired spontaneous and wound infections of the skin and skin structure.Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing infection and to determine their susceptibility to moxifloxacin. Therapy with Megaxin tablets may be initiated before results of these tests are known; once results become available, appropriate therapy should be continued.Consideration should be given to official guidance on the appropriate use of antibacterial agents.

تاريخ الترخيص:

2015-05-31

نشرة المعلومات

PATIENT LEAFLET IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986
This medicine is dispensed with a doctor’s prescription only
MEGAXIN TABLETS
FILM-COATED TABLETS
Each tablet contains:
moxifloxacin (as hydrochloride) 400 mg
Inactive ingredients and allergens: section 2 under "Important
information about
some of this medicine’s ingredients", and section 6 "Additional
information".
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE. This
leaflet contains concise information about this medicine. If you have
any further
questions, consult your doctor or pharmacist.
This medicine has been prescribed to treat your illness. Do not pass
it on to others.
It may harm them, even if it seems to you that their illness is
similar to yours.
1) WHAT IS THIS MEDICINE INTENDED FOR?
Megaxin is intended to treat patients above the age of 18 years for:
Infection of the airways - including acute bacterial sinusitis.
Worsening of chronic bronchitis. Megaxin tablets should only be used
to treat
these infections when other medicines intended to treat them cannot be
used or
the treatment with them has failed.
Non-severe cases of pneumonia. Megaxin tablets should only be used
when other
medicines intended to treat this infection cannot be used.
Skin infections.
THERAPEUTIC GROUP: Antibiotic of the fluoroquinolone group.
2) BEFORE USING THIS MEDICINE
DO NOT USE THIS MEDICINE IF:
You are sensitive (allergic) to moxifloxacin, any other quinolone
antibiotic or
any of the other ingredients of this medicine. For the list of
inactive ingredients,
see section 6 “Additional information”.
You are pregnant or breast-feeding.
You are under 18 years of age.
You have a history of tendon disease or tendon disorder which was
related to
treatment with quinolone antibiotics (see section 2 “Important
information
about some of this medicine’s ingredients” and section 4 “Side
effects”).
You were born with or have had any condition with abnormal heart
rhythm
(seen on ECG, electrical recording of the he

خصائص المنتج

1.
NAME OF THE MEDICINAL PRODUCT
MEGAXIN
® IV
Solution for infusion
Moxifloxacin (as hydrochloride) 400 mg/250 ml
MEGAXIN
® TABLETS
Film coated tablets
Moxifloxacin (as hydrochloride) 400 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
2.1
MEGAXIN TABLETS
are available as film-coated tablets containing moxifloxacin
hydrochloride (equivalent
to 400 mg moxifloxacin).
Excipient with known effect: The film-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.
2.2
MEGAXIN IV
is available in glass bottle 250 ml colorless glass type 2 for
infusion containing 400 mg of
moxifloxacin, as a sterile, preservative free, 0.8% sodium chloride
aqueous solution of moxifloxacin
hydrochloride (containing 400 mg moxifloxacin) with pH ranging from
4.1 to 4.6.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
MEGAXIN TABLETS
Oblong, dull red, film-coated tablets imprinted with “BAYER” on
one side and “M400” on the other containing
moxifloxacin hydrochloride (equivalent to 400 mg moxifloxacin).
MEGAXIN IV
Ready-to-use 250 mL bottle for infusion, containing moxifloxacin
hydrochloride (equivalent to 400 mg
moxifloxacin) in 0.8% sodium chloride aqueous solution. The appearance
of the intravenous solution is yellow.
Discard the unused portion of the drug.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
MEGAXIN IV
is indicated for the treatment of adults (>18 years of age) with
_ _
Community Acquired Pneumonia caused by Streptococcus pneumoniae,
Haemophilus influenzae, Moraxella
catarrhalis, Staphylococcus aureus, Klebsiella pneumoniae, Mycoplasma
pneumoniae or Chlamydia pneumoniae
and Complicated Skin and Skin
Structure Infections
caused by methicillin susceptible Staphylococcus aureus,
Escherichia coli, Klebsiella pneumoniae or Enterobacter cloacae.
_ _
Appropriate culture and susceptibility tests should be performed
before treatment in order to isolate and identify
organisms causing infection and to determine their sus