Country: Իսրայել
language: անգլերեն
source: Ministry of Health
MOXIFLOXACIN AS HYDROCHLORIDE
BAYER ISRAEL LTD
J01MA14
FILM COATED TABLETS
MOXIFLOXACIN AS HYDROCHLORIDE 0.4 G
PER OS
Required
BAYER AG., GERMANY
MOXIFLOXACIN
MOXIFLOXACIN
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.
2015-05-31
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 read_full_document
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 read_full_document