국가: 네덜란드
언어: 네덜란드어
출처: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
AMOXICILLINE 3-WATER SAMENSTELLING overeenkomend met ; AMOXICILLINE 0-WATER ; KALIUMCLAVULANAAT SAMENSTELLING overeenkomend met ; CLAVULAANZUUR
Teva Nederland B.V.
J01CR02
AMOXICILLINE 3-WATER COMPOSITION corresponding to ; AMOXICILLIN 0-WATER ; KALIUMCLAVULANAAT COMPOSITION corresponding to ; clavulanic acid
Filmomhulde tablet
CELLULOSE, MICROKRISTALLIJN (E 460) ; CETYLALCOHOL ; ETHYLCELLULOSE (E 462) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMLAURILSULFAAT (E 487) ; NATRIUMZETMEELGLYCOLAAT ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171) ; TRIETHYLCITRAAT (E 1505), CELLULOSE, MICROKRISTALLIJN (E 460) ; CETYLALCOHOL ; ETHYLCELLULOSE (E 462) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMLAURILSULFAAT (E 487) ; NATRIUMZETMEELGLYCOLAAT (E468) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171) ; TRIETHYLCITRAAT (E 1505),
Oraal gebruik
Amoxicillin and beta-lactamase inhibitor
Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); CETYLALCOHOL; ETHYLCELLULOSE (E 462); HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464); MAGNESIUMSTEARAAT (E 470b); NATRIUMLAURILSULFAAT (E 487); NATRIUMZETMEELGLYCOLAAT (E468); SILICIUMDIOXIDE (E 551); TALK (E 553 B); TITAANDIOXIDE (E 171); TRIETHYLCITRAAT (E 1505);
2008-08-28
Amoxicillin/Clavulanic acid, NL/H/1706/001, 09.10.2017 consolidated texts IB0016 and IA0017 1 BIJSLUITER: INFORMATIE VOOR DE PATIËNT AMOXICILLINE/CLAVULAANZUUR TEVA 500/125 MG, FILMOMHULDE TABLETTEN amoxicillin/clavulanic acid 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 __ is and what it is used for 2. What you need to know before you take _ 전체 문서 읽기_ 3. How to take _ _ 4. Possible side effects 5. How to store _ _ 6. Contens of pack and other information 1. WHAT _ _ IS AND WHAT IT IS USED FOR _ _ is an antibiotic and works by killing bacteria that cause infections. It contains two different medicines called amoxicillin and clavulanic acid. Amoxicillin belongs to a group of medicines called “penicillins” that can sometimes be stopped from working (made inactive). The other active component (clavulanic acid) stops this from happening. _ _ is used in adults and children to treat the following infections: middle ear and sinus infections, respiratory tract infections, urinary tract infections skin and soft tissue infections including dental infections bone and joint infections 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE _ _ DO NOT TAKE _ _ if you are allergic (hypersensitive) to amoxicillin, clavulanic acid, penicillin or any of the other ingredients of this medicine (listed in section 6) if you have ever had a severe allergic (hypersensitive) reaction to a
Amoxicillin/Clavulanic acid, NL/H/1706/001, 09.10.2017 consolidated texts IB0016 and IA0017 1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAAM VAN HET GENEESMIDDEL Amoxicilline/Clavulaanzuur Teva 500/125 mg, filmomhulde tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film coated tablet contains 583 mg amoxicillin trihydrate equivalent to 500 mg amoxicillin and 149 mg potassium clavulanate equivalent to 125 mg clavulanic acid. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film coated tablet. White to slightly yellowish, oblong, film coated tablets embossed on one side (“GG N6”). Dimension of tablets 10 x 21 mm. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _[PRODUCT NAME]_ is indicated for the treatment of the following infections in adults and children (see sections 4.2, 4.4 and 5.1): Acute bacterial sinusitis (adequately diagnosed) Acute otitis media, Acute exacerbation of chronic bronchitis (adequately diagnosed) Community acquired pneumonia. Cystitis Pyelonephritis Skin and soft tissue infections in particular, cellulitis, animal bites., severe dental abscess with spreading cellulitis.. Bone and joint infections, in particular osteomyelitis. Consideration should be given to official guidance on the appropriate use of antibacterial agents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Doses are expressed throughout in terms of amoxicillin/clavulanic acid content except when doses are stated in terms of an individual component. The dose of amoxicillin/clavulanic acid that is selected to treat an individual infection should take into account: The expected pathogens and their likely susceptibility to antibacterial agents (see section 4.4) The severity and the site of the infection The age, weight and renal function of the patient as shown below. Amoxicillin/Clavulanic acid, NL/H/1706/001, 09.10.2017 consolidated texts IB0016 and IA0017 2 The use of alternative presentations of amoxicillin/clavulanic acid (e.g. those that pro 전체 문서 읽기