Country: Израел
Језик: Енглески
Извор: Ministry of Health
AZITHROMYCIN AS DIHYDRATE
PFIZER PFE PHARMACEUTICALS ISRAEL LTD
J01FA10
CAPSULES
AZITHROMYCIN AS DIHYDRATE 250 MG
PER OS
Required
HAUPT PHARMA LATINA S.R.L, ITALY
AZITHROMYCIN
AZITHROMYCIN
Infections caused by susceptible organisms in lower respiratory tract including bronchitis and pneumonia, skin and soft tissue infections, otitis media, upper respiratory tract infections including sinusitis and pharyngitis, tonsilitis, also in the treatment of uncomplicated genital infections due to chlamydia trachomatis.
2015-02-28
Azenil Capsules, Azenil Suspension PIL CC 160723 Technical change 2023-0086619 1 PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS) - 1986 This medicine is dispensed with a doctor's prescription only AZENIL ® CAPSULES AZENIL ® 200 MG / 5 ML SUSPENSION EACH CAPSULE CONTAINS: azithromycin (as dihydrate) 250 mg EACH 5 ML OF SUSPENSION CONTAINS: azithromycin (as dihydrate) 200 mg Inactive ingredients and allergens: See section 2 under ‘Important information about some of this medicine’s ingredients' and section 6 'Further information'. READ THE ENTIRE LEAFLET CAREFULLY BEFORE 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 for you. Do not pass it on to others. It may harm them, even if it seems to you that their medical condition is similar to yours. Azenil 200 mg/5 ml Suspension is intended for children from 6 months of age. Azenil Capsules is intended for children weighing more than 45 kg. 1. WHAT IS THIS MEDICINE INTENDED FOR? • For the treatment of infections caused by bacteria susceptible to the preparation in the respiratory tract (bronchitis, pneumonia, sinusitis, pharyngitis and tonsillitis), skin and soft tissue, ear and genital infections caused by _Chlamydia trachomatis_. THERAPEUTIC GROUP: macrolide antibiotic. 2. BEFORE USING THIS MEDICINE DO NOT USE THIS MEDICINE IF: • You are sensitive (allergic) to the active ingredient (azithromycin) or to any of the other ingredients in this medicine (see section 6). • You have a history of allergic reaction to the preparation or to erythromycin or to any other antibiotic from the macrolide or ketolide group. • You have suffered in the past from jaundice resulting from bile flow obstruction in the liver (cholestatic jaundice) or from hepatic dysfunction that happened with the use of azithromycin. SPECIAL WARNINGS REGARDING USE OF THE MEDICINE Do not use this medicine without consulting a Прочитајте комплетан документ
Azenil 250mg Capsules, Azenil 200mg/5ml Suspension LPD CC 261221 1 2021-0070541 AZENIL ® CAPSULES AZENIL ® 200 MG/5 ML SUSPENSION NAME OF THE MEDICINAL PRODUCT AZENIL ® CAPSULES AZENIL ® 200 MG/5 ML SUSPENSION QUALITATIVE AND QUANTITATIVE COMPOSITION Azenil capsules: Each capsule contains Azithromycin dihydrate 262.05 mg equivalent to 250 mg azithromycin base. Azenil 200mg/5ml suspension: Contains Azithromycin 209.64 mg/5ml equivalent to 200mg/5ml of azithromycin base in Powder for Oral Suspension. Excipients with known effect: Azenil capsules: Lactose, sodium Azenil 200mg/5ml suspension: Sucrose, sodium For the full list of excipients, see Description (9) in this leaflet. PHARMACEUTICAL FORM Azenil capsules- The capsule is printed in black ink with Pfizer on one end of shell and “ZTM 250” on the other end. These capsules are packed in PVC blister packs. Azenil 200mg/5ml - Powder for suspension is presented as a dry powder which yields, on reconstitution with water, a white to off-white suspension. The powder for oral suspension is packed in polyethylene bottles. 1 INDICATIONS AND USAGE Infections caused by susceptible organisms in lower respiratory tract including bronchitis and pneumonia, skin and soft tissue infections, otitis media, upper respiratory tract infections including sinusitis and pharyngitis, tonsilitis, also in the treatment of uncomplicated genital infections due to chlamydia trachomatis. 1.1 LIMITATIONS OF USE Azithromycin should not be used in patients with pneumonia who are judged to be inappropriate for oral therapy because of moderate to severe illness or risk factors such as any of the following: • patients with cystic fibrosis, • patients with nosocomial infections, • patients with known or suspected bacteremia, • patients requiring hospitalization, • elderly or debilitated patients, or • patients with significant underlying health problems that may compromise their ability to respond to their illness (including immunodeficiency or functional asplenia). 1.2 USAGE Azenil Прочитајте комплетан документ