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AMOXICILLIN MLABS, AMOXICILLIN B&B, AMOXICILLIN MLPL (Micro Labs Pty Ltd)

Product name
AMOXICILLIN MLABS, AMOXICILLIN B&B, AMOXICILLIN MLPL
Date registered
Evaluation commenced
Decision date
Approval time
153 working days (255)
Active ingredients
amoxicillin trihydrate
Registration type
New generic medicine
Indication

AMOXICILLIN MLABS, AMOXICILLIN B&B, AMOXICILLIN MLPL (powder for oral suspension) are 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

AMOXICILLIN MLABS, AMOXICILLIN B&B, AMOXICILLIN MLPL (powder for oral suspension bottle pack) 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.

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