Pays: Israël
Langue: anglais
Source: Ministry of Health
AMOXICILLIN AS TRIHYDRATE; CLAVULANIC ACID AS POTASSIUM SALT
GLAXO SMITH KLINE (ISRAEL) LTD
J01CR02
POWDER FOR SUSPENSION
AMOXICILLIN AS TRIHYDRATE 600 MG / 5 ML; CLAVULANIC ACID AS POTASSIUM SALT 42.9 MG / 5 ML
PER OS
Required
SMITHKLINE BEECHAM PHARMACEUTICALS, UK
AMOXICILLIN AND ENZYME INHIBITOR
Augmentin ES is indicated for the treatment of acute otitis media in children aged at least 3 months and less than 40 kg body weight, caused or thought likely to be caused by penicillin-resistant Streptococcus pneumoniae:Consideration should be given to official guidance on the appropriate use of antibacterial agents.
2016-05-30
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986 The medicine is dispensed according to a physician’s prescription only AUGMENTIN ES 600 MG/5 ML POWDER FOR PREPARATION OF ORAL SUSPENSION Each 5 ml of suspension contains: 600 mg amoxicillin (as trihydrate) 42.9 mg clavulanic acid (as potassium salt) Each 1 ml of suspension contains: 120 mg amoxicillin (as trihydrate) 8.58 mg clavulanic acid (as potassium salt) A list of the additional ingredients is detailed in section 6. READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have further questions, refer to the physician or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them even if it seems to you that their medical condition is similar. 1. WHAT IS THE MEDICINE INTENDED FOR? AUGMENTIN ES 600 MG/5 ML is a medicine for treatment of middle ear infections caused by drug-sensitive bacteria in children from the age of 3 months and weighing less than 40 kg. Augmentin is an antibiotic that 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” whose action can sometimes be stopped (become inactive). The other active component (clavulanic acid) prevents this from happening. THERAPEUTIC GROUP Amoxicillin: Penicillin antibiotic group Clavulanic acid: Beta-lactamase enzyme inhibitors 2. BEFORE USING THE MEDICINE DO NOT GIVE YOUR CHILD AUGMENTIN IF: ∙ they are sensitive (allergic) to amoxicillin, clavulanic acid, penicillin or any of the additional ingredients contained in the medicine (listed in section 6) ∙ they have ever had a severe allergic reaction to any other antibiotic. This can include a skin rash or swelling of the face or throat ∙ they have ever had liver problems or jaundice (yellowing of the skin) when taking an antibiotic. → DO NOT GIVE AUGMENTIN Lire le document complet
1 Augmentin ES 600 mg/5 ml 1. NAME OF THE MEDICINAL PRODUCT Augmentin ES 600 mg/5 ml 2. QUALITATIVE AND QUANTITATIVE COMPOSITION When reconstituted, every ml of oral suspension contains amoxicillin trihydrate equivalent to 120 mg amoxicillin and potassium clavulanate equivalent to 8.58 mg of clavulanic acid. Excipient with known effect Excipient: Contains 2.72 mg of aspartame (E951) per ml. Contains maltodextrin (glucose). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for oral suspension. Off-white powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Augmentin _ES_ 600 mg/5 ml is indicated for the treatment of acute otitis media in children aged at least 3 months and less than 40 kg body weight, caused or thought likely to be caused by penicillin-resistant _Streptococcus pneumoniae_ (see sections 4.2, 4.4 and 5.1). 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 Augmentin _ES_ 600 mg/5 ml 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. Treatment should not be extended beyond 14 days without review (see section 4.4 regarding prolonged therapy). Adults and children ≥ 40 kg: There is no experience with Augmentin ES 600 mg/5 ml suspension in adults and children ≥ 40 kg, and therefore no dose recommendation can be given. 2 Children < 40 kg (aged ≥ 3 months) The recommended dose of Augmentin _ES_ 600 mg/5 ml suspension is 90/6.4 mg/kg/day in two divided doses. There are no clinical data on Augmentin _ES_ 600 mg/5 ml in children under 3 months of age. Renal impairment No dose ad Lire le document complet