Land: Israel
Språk: engelska
Källa: Ministry of Health
AZITHROMYCIN AS DIHYDRATE
PFIZER PFE PHARMACEUTICALS ISRAEL LTD
J01FA10
POWDER FOR SOLUTION FOR INFUSION
AZITHROMYCIN AS DIHYDRATE 500 MG/VIAL
I.V
Required
PFIZER PGM, FRANCE
AZITHROMYCIN
AZITHROMYCIN
Treatment of infections caused by susceptible strains of the designated microorganisms in the following conditions: community-acquired pneumonia and pelvic inflammatory disease.
2011-11-30
מ"עב לארשי הקיטבצמרפ יא ףא יפ רזייפ רקנש 'חר 9 .ד.ת , 12133 לארשי ,חותיפ הילצרה 46725 :לט 972-9-9700500 :סקפ 972-9-9700501 לירפא 2019 ,ה/דבכנ ת/חקור ,ה/אפור ןולעב ןוכדע לע ךעידוהל וננוצרב (אפורל ןולע תנוכתמב) ןכרצל : ZITHROMAX I.V. :ליעפה ביכרמה Azithromycin (as dihydrate) 500mg/vial INDICATED FOR: Treatment of infections caused by susceptible strains of the designated microorganisms in the acquired pneumonia and pelvic inflammatory disease. - following conditions: community ןולעב םיירקיעה םינוכדעה ןלהל :(אפורל ןולע תנוכתמב) ןכרצל .... ...... 7 DRUG INTERACTIONS .….. 7.3 POTENTIAL DRUG-DRUG INTERACTION WITH MACROLIDES Interactions with the following drugs listed below digoxin, colchicine or phenytoin have not been reported in clinical trials with azithromycin ; however,.No no specific drug interaction studies have been performed to evaluate potential drug-drug interaction. However, drug interactions have been observed with other macrolide products. Until further data are developed regarding drug interactions when digoxin, colchicine or phenytoin are used with azithromycin careful monitoring of patients is advised. ……. 8 USE IN SPECIFIC POPULATIONS 8.1 PREGNANCY TERATOGENIC EFFECTS. Pregnancy Category B: Risk Summary Available data from published literature and postmarketing experience over several decades with azithromycin use in pregnant women have not identified any drug-associated risks for major birth defects, miscarriage, or adverse maternal or fetal outcomes (see Data). Developmental toxicity studies with azithromycin in rats, mice, and rabbits showed no drug- induced fetal malformations at doses up to 4, 2, and 2 times, respectively, an adult human daily dose of 500 mg based on body surface area. Decreased viability and delayed development were observed in the offspring of pregnant rats administered azithromycin from day 6 Läs hela dokumentet
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 Läs hela dokumentet