Šalis: Nyderlandai
kalba: olandų
Šaltinis: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
AZITROMYCINE 1-WATER SAMENSTELLING overeenkomend met ; AZITROMYCINE 0-WATER
Sandoz B.V. Veluwezoom 22 1327 AH ALMERE
J01FA10
AZITHROMYCIN 1-WATER COMPOSITION corresponding to ; AZITHROMYCIN 0-WATER
Poeder voor orale suspensie
ASPARTAAM (E 951) ; HYPROLOSE (E 463) ; NATUURLIJKE EN KUNSTMATIGE SMAAKSTOFFEN ; SACCHAROSE ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171) ; TRINATRIUMFOSFAAT 0-WATER (E 339) ; XANTHAANGOM (E 415),
Oraal gebruik
Azithromycin
Hulpstoffen: ASPARTAAM (E 951); HYPROLOSE (E 463); NATUURLIJKE EN KUNSTMATIGE SMAAKSTOFFEN; SACCHAROSE; SILICIUMDIOXIDE (E 551); TITAANDIOXIDE (E 171); TRINATRIUMFOSFAAT 0-WATER (E 339); XANTHAANGOM (E 415);
2006-10-19
Sandoz BV Page 1/12 Azitromycine 200 mg/5 ml, poeder voor orale suspensie; RVG 34290 V17 1.3.1.3 Package Leaflet Juni 2020 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT AZITROMYCINE 200 MG/5 ML, POEDER VOOR ORALE SUSPENSIE azitromycine 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What [Nationally completed name] is and what it is used for 2. What you need to know before you take [Nationally completed name] 3. How to take [Nationally completed name] 4. Possible side effects 5. How to store [Nationally completed name] 6. Contents of the pack and other information 1 WHAT [NATIONALLY COMPLETED NAME] IS AND WHAT IT IS USED FOR Azithromycin is an antibiotic. It belongs to a group of antibiotics called macrolides. It is used to treat infections caused by bacteria. This medicine is usually prescribed to treat: - chest infections such as chronic bronchitis, pneumonia - infections of the tonsils, throat (pharyngitis) and sinuses - ear infections (acute otitis media) - skin and soft tissue infections, with exception of infected burn wounds - urethra and cervix infections caused by chlamydia. 2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE [NATIONALLY COMPLETED NAME] DO NOT TAKE [NATIONALLY COMPLETED NAME] IF YOU ARE ALLERGIC (HYPERSENSITIVE) TO: • azithromycin Sandoz BV Page 2/12 Azitromycine 200 mg/5 ml, poeder voor orale suspensie; RVG 34290 V17 1.3.1.3 Package Leaflet Juni 2020 • erythromycin • other macrolide or ketolide antibiotic • any of the other ingredients of this medicine (listed in section 6). WAR Perskaitykite visą dokumentą
Sandoz B.V. Page 1/23 Azitromycine 200 mg/5 ml, poeder voor orale suspensie; RVG 34290 V18 1.3.1.1 Summary of Product Characteristics Juni 2020 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Azitromycine 200 mg/5 ml, poeder voor orale suspensie 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _ _ Each 5 ml reconstituted suspension contains 102.4 mg of azithromycin monohydrate equivalent to 100 mg of azithromycin. Each 1 ml reconstituted suspension contains 20.48 mg of azithromycin monohydrate equivalent to 20 mg of azithromycin. Excipients with known effect Each 5 ml reconstituted suspension contains 3.81 g of sucrose, 0.030 g of aspartame (E 951) and up to 130 nanograms of sulphites. Each 5 ml reconstituted suspension contains 204.8 mg of azithromycin monohydrate equivalent to 200 mg of azithromycin. Each 1 ml reconstituted suspension contains 40.96 mg of azithromycin monohydrate equivalent to 40 mg of azithromycin. Excipients with known effect Each 5 ml reconstituted suspension contains 3.70 g of sucrose, 0.030 g of aspartame (E 951) and up to 130 nanograms of sulphites. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for oral suspension. White to off-white crystalline powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Azithromycin powder for oral suspension is indicated for the treatment of the following infections, when caused by micro-organisms sensitive to azithromycin (see section 4.4 and 5.1): Sandoz B.V. Page 2/23 Azitromycine 200 mg/5 ml, poeder voor orale suspensie; RVG 34290 V18 1.3.1.1 Summary of Product Characteristics Juni 2020 − 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 − skin and soft tissue infections − uncomplicated _Chlamydia trachomatis_ urethritis and cervicitis Considerations should be given to official guidance o Perskaitykite visą dokumentą