Šalis: Izraelis
kalba: anglų
Šaltinis: Ministry of Health
MOXIFLOXACIN AS HYDROCHLORIDE
BAYER ISRAEL LTD
J01MA14
SOLUTION FOR INFUSION
MOXIFLOXACIN AS HYDROCHLORIDE 1.6 MG/ML
I.V
Required
BAYER AG., GERMANY
MOXIFLOXACIN
MOXIFLOXACIN
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.
2022-08-31
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._ Perskaitykite visą dokumentą
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 Perskaitykite visą dokumentą