البلد: إسرائيل
اللغة: الإنجليزية
المصدر: 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
GLAXO WELLCOME PRODUCTION, FRANCE
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.
2016-05-31
( ) " - 1986 ES 600 " / 5 " 5 " : 600 ( " - ) amoxicillin (as trihydrate) 42.9 ( " ) clavulanic acid (as potassium salt) 1 : " 120 ( " - ) amoxicillin (as trihydrate) 8.58 ) ( " clavulanic acid (as potassium salt) 6 . . . , . . . . 1 . ? 600 ES " / 5 " 3 - 40 ." . . ( " " . ) ( .) : : - 2 . : • , , ) ( ( 6 ) • . • . ) ( ← . , . : , • • • . , . , , . . . , ( , . ) . , ' ' 4 . ( ,) ( ) . . , , , , , . • ( , ) . • ( ,) . • ) ( . , • ( .) • ( .) , , . . . . • 2.72 ( " E 951 ) 1 . " ," " . . • .) ( . , • - 23 " 5 . " 3 . ? . . : . 40 " • 40 . " . - 40 " . • . • . . 3 . • . . • . : ( , . ) ( , : . ) • • • , , 4 . 2 . • . . , ( . . ) , . , . , , . , - 4 . - 4 . . . . , . . ! . . , . 4 . , 600 ES /" 5 " . . . . : : • • ( ) , • , , , • ( , ,) • . • , ( - Kounis syndrome ) . ← . . , , / . ) ( ( DIES ) DIES / . ( 1-4 .) , ) ( , . ( acute pancreatitis ) . ← . : - 1 10 : • .) ( - 1 10 : • ( - ) , • , ← , • • .) ( - 1 100 : • , • ( ) • • • . : • . - 1 1,000 : • ( , , - erythema multiforme ) ← . : • • . ( ) • ) ( • ) ( • ) ( ( DIES ) ) ( • ( acute pancreatitis ) ) ( • ( ) • : - , , , ( - ' , ,) ( - 30% - ) - ( bullous exfoliative dermatitis ) - , ( exanthematous pustulosis ) - , , , ) ] [ ( [ ( DRESS .)] - ( IgA ) ← . • ( ) • ( , ) • • • ) ( • ) ( • • . ,) ( : • • ( ) • . , . , " " ( www.health.gov.il " , ) : https://sideeffects.health.gov.il/ 5 . ? • ! . / . • ( exp. date ) . . : • 25°C . • . : • ( 2°C 8°C . .) • , 10 . • . . . 6 . • : Silicon dioxide, colloidal anhydrous silica, carboxymethyl cellulose sodium, artificial strawberry cream flavour (including maltodextrine), aspartame (E951) and xanthan gum. ' ' 2 . • : . ES 600 /" 5 " , . 100 " . • ' ," ) ( : 25 . , • : . , , , , ' . • 2023 . • : 145-87-33332 . • , . , . • GSK . 2023© GSK . : . . . 1 . . 2 . . 3 . . 4 . 100 " 90 " . , . AugES PT v10B اقرأ الوثيقة كاملة
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 Every ml of oral suspension contains 2.72 mg aspartame (E951). The flavouring in Augmentin ES 600 mg/5 ml contains maltodextrin (glucose) (see section 4.4). 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 اقرأ الوثيقة كاملة