국가: 몰타
언어: 영어
출처: Medicines Authority
AMOXICILLIN, CLAVULANIC ACID
Bial - Portela & C S.A. À Av. da Siderurgia Nacional, 4745-457 S. Mamede do Coronado, Portugal
J01CR02
AMOXICILLIN 400 mg/5ml CLAVULANIC ACID 57 mg/5ml
POWDER FOR ORAL SUSPENSION
AMOXICILLIN 400 mg/5ml CLAVULANIC ACID 57 mg/5ml
POM
ANTIBACTERIALS FOR SYSTEMIC USE
Withdrawn
2005-10-26
PACKAGE LEAFLET: INFORMATION FOR THE USER NOPRILAM DT 400 400 MG/57 MG/5 ML POWDER FOR ORAL SUSPENSION Amoxicillin/clavulanic acid READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START GIVING YOUR CHILD THIS MEDICINE. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine is usually prescribed for a baby or child. Do not pass it on to others. It may harm them, even if their symptoms are the same as your child’s. - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What Noprilam is and what it is used for 2. Before you give Noprilam 3. How to give Noprilam 4. Possible side effects 5. How to store Noprilam 6. Further information 1. WHAT NOPRILAM IS AND WHAT IT IS USED FOR Noprilam 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. Noprilam is used in babies 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. BEFORE YOU GIVE NOPRILAM DO NOT GIVE YOUR CHILD NOPRILAM: • if they are allergic (hypersensitive) to amoxicillin, clavulanic acid or any of the other ingredients of Noprila 전체 문서 읽기
Page 1 of 11 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT NOPRILAM DT 400, 400/57 mg/5 ml Powder for oral suspension NOPRILAM 500, 500/125 mg Coated tablets NOPRILAM DT, 875/125 mg Coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION NOPRILAM contains amoxicillin (as trihydrate) and clavulanic acid (as potassium salt): Pharmaceutical form Amoxicillin contents Clavulanic acid contents Ratio AMOX/CL AV NOPRILAM DT 400 Oral Suspension 400 mg (5 ml) 57 mg (5 ml) 7/1 NOPRILAM 500 Tablets 500 mg 125 mg 4/1 NOPRILAM DT Tablets 875 mg 125 mg 7/1 Excipients, see 6.1. 3. PHARMACEUTICAL FORM NOPRILAM DT 400: Powder for oral suspension. NOPRILAM 500 and NOPRILAM DT: Coated tablets. 4. CLINICAL PARTICULARS NOPRILAM, a beta-lactam antibiotic of the penicillin group, co-formulated with a beta- lactamase inhibitor, is a broad spectrum antibacterial agent with activity upon the commonest pathogenic bacteria found in clinical and hospital practice. The inhibition action of clavulanic acid upon beta-lactamases allows broadening of the amoxicillin spectrum of action, involving any organisms resistant to other beta-lactam antibiotics. 4.1 THERAPEUTIC INDICATIONS NOPRILAM is indicated for the short-term treatment of a wide range of infections caused by susceptible organisms to NOPRILAM Upper respiratory tract infections (including ENT), e.g. recurrent tonsillitis, recurrent and acute sinusitis and otitis media, typically caused by: _Streptococcus pneumoniae,_ _Haemophilus influenzae*, Moraxella catarrhalis* _and_ Streptococcus pyogenes_. Lower respiratory tract infections, e.g. exacerbation of chronic bronchitis, lobar pneumonia and bronchopneumonia typically caused by: _Streptococcus pneumoniae,_ _Haemophilus _ _influenzae*, Moraxella catarrhalis*_. Geni 전체 문서 읽기