Страна: Австралия
Език: английски
Източник: Department of Health (Therapeutic Goods Administration)
amoxicillin trihydrate, Quantity: 57.4 mg/mL (Equivalent: amoxicillin, Qty 50 mg/mL)
Micro Labs Pty Ltd
Suspension, powder for
Excipient Ingredients: sorbitol; sodium benzoate; saccharin sodium; disodium edetate; xanthan gum; silicon dioxide; Flavour
Oral
Amoxicillin powder for oral suspension packed in bottle of 150mL along with 28mm screw cap
(S4) Prescription Only Medicine
It is indicated for the treatment of the following infections due to susceptible strains of sensitive organisms:,Note: Therapy should be guided by bacteriological studies, including sensitivity tests, and by clinical response. However, in emergency cases where the causative organism has not been identified, therapy with amoxicillin may be useful. Clinical judgement will decide whether combination with another antibiotic would provide a sufficiently broad spectrum of activity pending sensitivity test results.,Skin and Skin Structure: Staphylococcus, non-penicillinase producing; Streptococcus; E.coli,Respiratory (Acute and Chronic): H.influenzae, Streptococcus; S.pneumoniae; staphylococcus, non-penicillinase-producing; E.coli,Genitourinary Tract (complicated and uncomplicated, Acute and Chronic): E.coli, P.mirabilis and S.faecalis.,Gonorrhoea: N.gonorrhoeae (non-penicillinase producing).,Prophylaxis of endocarditis: [Trade name] may be used for the prophylaxis of bacterial endocarditis in individuals at particular risk, such as those with a prosthetic heart valve or those who have previously had endocarditis.
Visual Identification: Unconstituted powder: white to pale yellow free flowing powder. Reconstituted: pale yellow to yellow coloured suspension with fruity aromatic odor.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius
Registered
2019-04-08
1 AUSTRALIAN PRODUCT INFORMATION - AMOXICILLIN MLABS (AMOXICILLIN TRIHYDRATE) 1. NAME OF THE MEDICINE Amoxicillin trihydrate 2. QUALITATIVE AND QUANTITATIVE COMPOSITION When reconstituted, every 5 ml of oral suspension contains amoxicillin trihydrate equivalent to 125 mg amoxicillin (25 mg per ml) for strength 125mg/5mL Oral suspension When reconstituted, every 5 ml of oral suspension contains amoxicillin trihydrate equivalent to 250 mg amoxicillin (50 mg per ml) for strength 250mg/5mL Oral suspension. Amoxicillin MLabs contains the inactive ingredients Sodium benzoate and sorbitol. For the full list of excipients, see Section 6.1 List of excipients 3. PHARMACEUTICAL FORM Dry Powder for oral suspension. White to pale yellow free flowing powder for Oral suspension, which when constituted with water forms Pale yellow to yellow colored suspension with fruity aromatic odor. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS It is indicated for the treatment of the following infections due to susceptible strains of sensitive organisms: Note: Therapy should be guided by bacteriological studies, including sensitivity tests, and by clinical response. However, in emergency cases where the causative organism has not been identified, therapy with amoxicillin may be useful. Clinical judgement will decide whether combination with another antibiotic would provide a sufficiently broad spectrum of activity pending sensitivity test results. Skin and Skin Structure: Staphylococcus, non-penicillinase producing; Streptococcus; _E.coli_ (see Section 5.1 Pharmacodynamic Properties (Microbiology)). 2 Respiratory (Acute and Chronic): _H.influenzae_, Streptococcus; _S.pneumoniae_; staphylococcus, non-penicillinase-producing; _E.coli _ (see Section 5.1 Pharmacodynamic Properties (Microbiology)). Genitourinary Tract (complicated and uncomplicated, Acute and Chronic): _ E.coli_, (see Section 5.1 Pharmacodynamic Properties (Microbiology)), _P.mirabilis and S.faecalis. _ Gonorrhoea: _N.gonorrhoeae_ (non-penicillinase producing). Prophylaxis Прочетете целия документ