Страна: Нидерландия
Език: нидерландски
Източник: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
CEFUROXIMAXETIL SAMENSTELLING overeenkomend met ; ; CEFUROXIM 500 mg/stuk
Sandoz B.V. Veluwezoom 22 1327 AH ALMERE
J01DC02
CEFUROXIMAXETIL SAMENSTELLING overeenkomend met ; ; CEFUROXIM 500 mg/stuk
Omhulde tablet
AARDAPPELZETMEEL, OPLOSBAAR ; ASPARTAAM (E 951) ; CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; COPOVIDON (E 1208) ; CROSCARMELLOSE NATRIUM (E 468) ; CROSPOVIDON (E 1202) ; MAGNESIUMSTEARAAT (E 470b) ; MANNITOL (D-) (E 421) ; NATRIUMLAURILSULFAAT ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171), AARDAPPELZETMEEL, OPLOSBAAR ; ASPARTAAM (E 951) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; COPOVIDON ; CROSCARMELLOSE NATRIUM (E 468) ; CROSPOVIDON (E 1202) ; MAGNESIUMSTEARAAT (E 470b) ; MANNITOL (D-) (E 421) ; NATRIUMLAURILSULFAAT (E 487) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171), AARDAPPELZETMEEL, OPLOSBAAR ; ASPARTAAM (E 951) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; COPOVIDON ; CROSCARMELLOSE NATRIUM (E 468) ; CROSPOVIDON (E 1202) ; MAGNESIUMSTEARAAT (E 470b) ; MANNITOL (D-) (E 421) ; NATRIUMLAURILSULFAAT (E 487) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171),
Oraal gebruik
Cefuroxime
Hulpstoffen: AARDAPPELZETMEEL, OPLOSBAAR; ASPARTAAM (E 951); CELLULOSE, MICROKRISTALLIJN (E 460); COPOVIDON; CROSCARMELLOSE NATRIUM (E 468); CROSPOVIDON (E 1202); MAGNESIUMSTEARAAT (E 470b); MANNITOL (D-) (E 421); NATRIUMLAURILSULFAAT (E 487); SILICIUMDIOXIDE (E 551); TALK (E 553 B); TITAANDIOXIDE (E 171);
1900-01-01
Sandoz B.V. Page 1/8 Cefuroximaxetil 125, 250 en 500, omhulde tabletten 125, 250 en 500 mg RVG 26702-3-4 1313-v11b 1.3.1.3 Bijsluiter October 2023 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT CEFUROXIMAXETIL 125, OMHULDE TABLETTEN 125 MG CEFUROXIMAXETIL 250, OMHULDE TABLETTEN 250 MG CEFUROXIMAXETIL 500, OMHULDE TABLETTEN 500 MG CEFUROXIME 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 [Nationally completed name] is an antibiotic used in adults and children. It works by killing bacteria that cause infections. It belongs to a group of medicines called _cephalosporins_ . [Nationally completed name] is used to treat infections of: • the throat • sinus • middle ear • the lungs or chest • the urinary tract • the skin and soft tissues. [Nationally completed name] can also be used: • to treat Lyme disease (an infection spread by parasites called ticks). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE [ NATIONALLY COMPLETED NAME] DO NOT TAKE [ NATIONALLY COMPLETED NAME]: Sandoz B.V. Page 2/8 Cefuroximaxetil 125, 250 en 500, omhulde tabletten 125, 250 en 500 mg RVG 26702-3-4 1313-v11b 1.3.1.3 Bijsluiter October 2023 - IF YOU ARE ALLERGIC to cefuroxime, to A Прочетете целия документ
Sandoz B.V. Page 1/14 Cefuroximaxetil 125, 250 en 500, omhulde tabletten 125, 250 en 500 mg RVG 26702-3-4 1311-v11b 1.3.1.1 Samenvatting van de Productkenmerken October 2023 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Cefuroximaxetil 125, omhulde tabletten 125 mg Cefuroximaxetil 250, omhulde tabletten 250 mg Cefuroximaxetil 500, omhulde tabletten 500 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 125 mg coated tablet contains 150.36 mg cefuroxime (as axetil). Excipients with known effect Each coated tablet contains 0.2 mg aspartame (E951). Each 250 mg coated tablet contains 300.72 mg cefuroxime (as axetil). Each 500 mg coated tablets contain 601.44 mg cefuroxime (as axetil). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Coated tablets. _125 mg coated tablets: _ White to slightly yellowish, biconvex, oblong tablets. _250 mg coated tablets: _ White to slightly yellowish, biconvex, oblong tablets, scored on both sides. _500 mg coated tablets: _ White to slightly yellowish, biconvex, oblong tablets. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Sandoz B.V. Page 2/14 Cefuroximaxetil 125, 250 en 500, omhulde tabletten 125, 250 en 500 mg RVG 26702-3-4 1311-v11b 1.3.1.1 Samenvatting van de Productkenmerken October 2023 [Nationally completed name] is indicated for the treatment of the infections listed below in adults and children from the age of 3 months (see sections 4.4 and 5.1). - Acute streptococcal tonsillitis and pharyngitis. - Acute bacterial sinusitis. - Acute otitis media. - Acute exacerbations of chronic bronchitis. - Cystitis - Pyelonephritis. - Uncomplicated skin and soft tissue infections. - Treatment of early Lyme disease. Consideration should be given to official guidance on the appropriate use of antibacterial agents. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION Posology The usual course of therapy is seven days (may range from five to ten days). _Table 1. Adults and children (≥40 kg) _ INDICATION DOSAGE Acute tonsillitis and pharyngitis, acut Прочетете целия документ