Negara: Belanda
Bahasa: Belanda
Sumber: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
AZITROMYCINE 2-WATER 262,1 mg/stuk SAMENSTELLING overeenkomend met ; AZITROMYCINE 0-WATER 250 mg/stuk
Ratiopharm GmbH Graf-Arco-Strasse 3 89079 ULM (DUITSLAND)
J01FA10
AZITROMYCINE 2-WATER 262,1 mg/stuk SAMENSTELLING overeenkomend met ; AZITROMYCINE 0-WATER 250 mg/stuk
Filmomhulde tablet
CALCIUMWATERSTOFFOSFAAT 0-WATER (E 341) ; CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; HYPROMELLOSE (E 464) ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL ; MAÏSZETMEEL, GEPREGELATINEERD ; NATRIUMLAURILSULFAAT ; POLYSORBAAT 80 (E 433) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171), CALCIUMWATERSTOFFOSFAAT 0-WATER (E 341) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; HYPROMELLOSE (E 464) ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL ; MAÏSZETMEEL, GEPREGELATINEERD ; NATRIUMLAURILSULFAAT (E 487) ; POLYSORBAAT 80 (E 433) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171),
Oraal gebruik
Azithromycin
Hulpstoffen: CALCIUMWATERSTOFFOSFAAT 0-WATER (E 341); CELLULOSE, MICROKRISTALLIJN (E 460); HYPROMELLOSE (E 464); MAGNESIUMSTEARAAT (E 470b); MAÏSZETMEEL; MAÏSZETMEEL, GEPREGELATINEERD; NATRIUMLAURILSULFAAT (E 487); POLYSORBAAT 80 (E 433); TALK (E 553 B); TITAANDIOXIDE (E 171);
1900-01-01
Azithromycin, NL/H/2415/001-002, 09.03.21 1 PACKAGE LEAFLET: INFORMATION FOR THE USER Azitromycine ratiopharm 250 mg, filmomhulde tabletten Azitromycine ratiopharm 500 mg, filmomhulde tabletten azithromycin (as dihydrate) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor or pharmacist. • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. • If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What {Product name} is and what it is used for 2. What you need to know before you take {Product name} 3. How to take {Product name} 4. Possible side effects 5. How to store {Product name} 6. Contents of the pack and other information 1. WHAT {PRODUCT NAME} IS AND WHAT IT IS USED FOR Azithromycin is one of a group of antibiotics called macrolides. It is used to treat infections caused by micro-organisms such as bacteria. These infections include: • Chest infections such as acute exacerbation of chronic bronchitis and pneumonia • Infections in your sinuses, throat, tonsils or ears • Mild to moderate skin and soft tissue infections, _e.g._ infection of the hair follicles (folliculitis), bacterial infection of the skin and its deeper layers (cellulitis), skin infection with shiny red swelling (erysipelas) • Infections caused by a bacterium called _Chlamydia trachomatis_ . They can cause inflammation of the tube that carries urine from your bladder (urethra) or where your womb joins your vagina (cervix). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE {PRODUCT NAME} DO NOT TAKE {PRODUCT NAME} • if you are allergic to azithromycin or any of the other ingredients of this medicine (listed in section 6) • if you are allergic to any other macrol Baca dokumen lengkapnya
Azithromycin, NL/H/2415/001-002, 25.04.2022 1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Azitromycine ratiopharm 250 mg, filmomhulde tabletten Azitromycine ratiopharm 500 mg, filmomhulde tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 250 mg tablets: Each film-coated tablet contains 250 mg azithromycin (as dihydrate). 500 mg tablets: Each film-coated tablet contains 500 mg azithromycin (as dihydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. 250 mg tablets: White, oblong biconvex film-coated tablet 14.5 x 7.5 mm with imprint ‘AI 250’ on one side. 500 mg tablets: Pale blue, oblong, biconvex film-coated tablet 19.0 x 8.0 mm with imprint ‘AI 500’ and score line on one side. The tablet can be divided into equal doses. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the treatment of the following infections when caused by micro-organisms sensitive to azithromycin (see sections 4.4 and 5.1): - Acute bacterial sinusitis (adequately diagnosed) - Acute bacterial otitis media (adequately diagnosed) - Pharyngitis, tonsillitis - Acute exacerbation of chronic bronchitis (adequately diagnosed) - Mild to moderately severe community-acquired pneumonia - Infections of the skin and soft tissues of mild to moderate severity e.g. folliculitis, cellulitis, erysipelas - Uncomplicated _Chlamydia trachomatis _ urethritis and cervicitis Consideration should be given to official guidance on the appropriate use of antibacterial agents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY The duration of treatment in each of the infectious diseases is given below. Paediatric population over 45 kg body weight, adults The total dosage of azithromycin is 1,500 mg which is spread over three days (500 mg once daily). Alternatively, the dosage can be spread over five days (500 mg as a single dose on the first day and thereafter 250 mg once daily). Azithromycin, NL/H/2415/001-002, 25.04.2022 2 In uncomplicated _Chlamydia trachomatis _ urethritis and ce Baca dokumen lengkapnya