Држава: Арменија
Језик: Енглески
Извор: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
amoxicillin (amoxicillin trihydrate), clavulanic acid (potassium clavulanate)
Glaxo Wellcome Production
J01C R02
amoxicillin (amoxicillin trihydrate), clavulanic acid (potassium clavulanate)
600mg/5ml+ 42.9mg/5ml
powder for oral suspension with strawberry flavour
glass bottle 100ml and measuring spoon 5ml
Prescription
Registered
2015-09-04
Others: Chlamydia pneumoniae Chlamydia psittaci Chlamydia spp. Coxiella burnetti Mycoplasma spp. Pharmacokinetics Pharmacokinetic parameters are given below for AUGMENTIN ES administered at 45mg/kg every 12 hours to paediatric patients Formulation C max (mg/L) T max (hours) AUC (mg.h/L) T ½ (hours) AUGMENTIN ES 600/42.9 mg/5ml Dosed at 45 mg/kg amoxicillin 12-hourly Amoxicillin 15.7 2.0 59.8 1.4 Clavulanate 1.7 1.1 4.0 1.1 The pharmacokinetics of the two components of AUGMENTIN ES are closely matched. Both clavulanate and amoxicillin have low levels of serum binding; about 70% remains free in the serum. Pre-clinical Safety Data No further information of relevance. PHARMACEUTICAL PARTICULARS List of Excipients Orange flavour Powder for oral suspension: colloidal silicon dioxide, orange flavour, golden syrup flavour, xanthan gum, aspartame, hydroxypropylmethylcellulose and silicon dioxide. Strawberry cream flavour Powder for oral suspension: colloidal silicon dioxide, sodium carboxymethylcellulose-12, strawberry cream flavour, xanthan gum, aspartame, and silicon dioxide. Incompatibilities None known. Shelf Life The expiry date is indicated on the packaging. Special Precautions for Storage The powder for oral suspension should be stored in a well sealed container, in a dry place at or below 25 ° C. Reconstituted suspensions should be stored in a refrigerator (2-8 ° C) and used within 10 days. Nature and Contents of Container AUGMENTIN ES powder for oral suspension, will be supplied as a dry powder suitable for reconstitution. Orange flavour The dry powder is filled into glass bottles with polypropylene caps. Strawberry cream flavour The dry powder is filled into glass bottles with aluminium caps with a PVC liner. Instructions for Use/Handling At time of dispensing, the dry powder should be reconstituted to form an oral suspension, as detailed below: • Check cap seal is intact before use. • Invert and shake bottle to loosen powder. • Add volume of water (indicated below). Invert and shake well. • Alternati Прочитајте комплетан документ
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Augmentin ES 600 mg'42.9 mgz S ml powder for oral suspension 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 (E95 I) per m!. 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 is indicated for the treatment of the following infections 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): • Acute otitis media Community acquired pneumonia. • 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 amoxiciII inlclavulanic acid content except when doses are stated in terms of an individual component. The dose of Augmentin 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). 2 dults and children> 40 kg: There is no experience with Augmentin suspension in adults and children ~ 40 kg, and therefore no dose recommendation can be given. Children < 40 kg Caged> 3 months) The recommended dose of Augmentin suspension is _90/6.4_ rug/kg/day in two divided doses. There are no clinical data on Augmentin in children under 3 months of age. Renal impairment No dose adjustment i Прочитајте комплетан документ