MEGAXIN IV

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

MOXIFLOXACIN

Available from:

BAYER ISRAEL LTD

ATC code:

J01MA14

Pharmaceutical form:

SOLUTION FOR INFUSION

Composition:

MOXIFLOXACIN 400 MG / 250 ML

Administration route:

I.V

Prescription type:

Required

Manufactured by:

BAYER AG., GERMANY

Therapeutic group:

MOXIFLOXACIN

Therapeutic area:

MOXIFLOXACIN

Therapeutic indications:

Megaxin IV is indicated for the treatment of adults (> 18 years of age) with Community acuired 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 staphylococus 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 susceptibility to moxifloxacin. Therapy with Megaxin may be initiated before results of these tests are known; once results become available ,appropriate therapy should be continued.

Authorization date:

2012-11-21

Patient Information leaflet

העדוה
העדוה
לע
לע
הרמחה
הרמחה
(
(
עדימ
עדימ
ןולעב )תוחיטב
ןולעב )תוחיטב
ל
ל
אפור
אפור
ןכדועמ(
ןכדועמ(
05.2013
05.2013
)
)
ךיראת
__
16/07/2014
__
םש
רישכת
תילגנאב
רפסמו
םושירה
MEGAXIN IV 126-36-30540-00/01
םש
לעב
םושירה
_____
רייאב
לארשי
מ"עב
__________
ספוט
הז
דעוימ
טורפל
תורמחהה
דבלב
!
תורמחהה
תושקובמה
קרפ
ןולעב
טסקט
יחכונ
טסקט
שדח
5 WARNINGS AND
PRECAUTIONS
5.12
_VISION_ _DISORDERS_
_If vision becomes impaired or any _
_effects on the eyes are experienced, _
_an eye specialist should be consulted _
_immediately._

Summary of Product characteristics

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