Amoxicillin-Apotex

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

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Active ingredient:

Amoxicillin trihydrate 62.5708 mg/mL equivalent to Amoxycillin 50 mg/mL (+5% overage);  

Available from:

Apotex NZ Ltd

INN (International Name):

Amoxicillin trihydrate 62.5708 mg/mL (=Amoxycillin 50 mg/mL; +5% overage)

Dosage:

250 mg/5mL

Pharmaceutical form:

Powder for oral suspension

Composition:

Active: Amoxicillin trihydrate 62.5708 mg/mL equivalent to Amoxycillin 50 mg/mL (+5% overage)   Excipient: Colloidal silicon dioxide Saccharin sodium Sodium citrate dihydrate Sorbitol Sunset yellow FCF Tutti frutti flavour 051880 AP0551 Xanthan gum

Units in package:

Bottle, plastic, HDPE, 100 mL

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

DSM Sinochem Pharmaceuticals India Private Limited

Therapeutic indications:

Amoxicillin is indicated for the treatment of the following infections due to susceptible strains of sensitive organisms: Upper Respiratory Infections: Otitis media, pharyngitis, sinusitis and tonsillitis. Lower Respiratory Infections: Bronchitis, bronchopneumonia and lobar pneumonia. Urinary Tract Infections: Cystitis, cysto-pyelitis, urethritis, and gonococcal urethritis. Prophylaxis: against ??-haemolytic (viridans group) and ??-haemolytic Streptococci before dental, oral or upper respiratory tract surgery or instrumentation. Prophylaxis: of bacterial endocarditis in patients with any of the following conditions: congenital cardiac malformations, rheumatic and other acquired valvular lesions, prosthetic heart valves, previous history of bacterial endocarditis, hypertrophic cardiomyopathy, surgically constructed systemicpulmonary shunts, mitral valve prolapse with valvular regurgitation or mitral valve prolapse without valvular regurgitation but associated with thickening and/or redundancy of

Product summary:

Package - Contents - Shelf Life: Bottle, plastic, HDPE - 100 mL - 24 months from date of manufacture stored at or below 25°C 14 days reconstituted stored at 2° to 8°C (Refrigerate, do not freeze)

Authorization date:

2000-04-06