Ospamox

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Amoxicillin trihydrate 114.8 mg/mL equivalent to 100 mg/mL amoxycillin;  

Available from:

Sandoz New Zealand Limited

INN (International Name):

Amoxicillin trihydrate 114.8 mg/mL (equivalent to 100 mg/mL amoxycillin)

Dosage:

100 mg/mL

Pharmaceutical form:

Powder for oral suspension

Composition:

Active: Amoxicillin trihydrate 114.8 mg/mL equivalent to 100 mg/mL amoxycillin   Excipient: Aspartame Citric acid Guar gum Hydrated silica Lemon flavour 15020598 Orange flavour 055301 AP0551 Peach-apricot flavour 26F22 Purified talc Sodium benzoate Sodium citrate

Units in package:

Bottle, HDPE, 60 mL

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Sandoz Industrial Products SA

Therapeutic indications:

Treatment of infection Ospamox is indicated in the treatment of infections due to susceptible organisms. Ospamox may be useful in instituting therapy prior to bacteriology; however bacteriological studies to determine the causative organisms and their sensitivity to amoxicillin should be performed.

Product summary:

Package - Contents - Shelf Life: Bottle, glass, amber - 100 mL - 36 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:

1999-01-28

Summary of Product characteristics

100317-Ospamox-ds
Page 1 of 15
NEW ZEALAND DATA SHEET
OSPAMOX (AMOXICILLIN THIHYDRATE) POWDER FOR ORAL
SUSPENSION
1.
PRODUCT NAME
Amoxicillin Trihydrate dried suspension 125 mg/5 ml, 250 mg/5 ml and
100 mg/ml (as
amoxicillin)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_OSPAMOX POWDER FOR ORAL SUSPENSION _
125 mg/5 ml: Reconstituted suspension contains in 5 ml, Amoxicillin
Trihydrate Ph Eur
equivalent to amoxicillin 125 mg.
250 mg/5 ml: Reconstituted suspension contains in 5 ml, Amoxicillin
Trihydrate Ph Eur
equivalent to amoxicillin 250 mg.
500 mg/5 ml: Reconstituted suspension contains in 5 ml, Amoxicillin
Trihydrate Ph Eur
equivalent to amoxicillin 500 mg.
_OSPAMOX PAEDIATRIC DROPS 100 MG/ML _
Reconstituted suspension contains in 1 ml, Amoxicillin Trihydrate Ph
Eur equivalent to
amoxicillin 100 mg.
For the full list of excipients, see Section 6.1.
3.
PHARMACEUTICAL FORM
_OSPAMOX POWDER FOR ORAL SUSPENSION _
125 mg/5 ml: Suspension, oral, powder for, white to yellowish colour.
250 mg/5 ml: Suspension, oral, powder for, white to yellowish colour.
500 mg/5 ml: Suspension, oral, powder for, white to yellowish colour.
_OSPAMOX PAEDIATRIC DROPS 100 MG/ML _
Suspension, oral, granules for, white to yellowish colour.
4.
CLINICAL PARTICULARS
4.1.
T
HERAPEUTIC INDICATIONS
_TREATMENT OF INFECTION _
Ospamox is indicated in the treatment of infections due to susceptible
organisms.
Ospamox may be useful in instituting therapy prior to bacteriology;
however, bacteriological
studies to determine the causative organisms and their sensitivity to
amoxicillin should be
performed.
_PROPHYLAXIS FOR ENDOCARDITIS _
Ospamox may be used for the prevention of bacteraemia, associated with
procedures such as
dental extraction, in patients at risk of developing bacterial
endocarditis.
100317-Ospamox-ds
Page 2 of 15
4.2.
D
OSE AND METHOD OF ADMINISTRATION
DOSAGE
_UPPER RESPIRATORY TRACT INFECTIONS, GENITO-URINARY TRACT INFECTIONS,
SKIN AND SOFT TISSUE _
_INFECTIONS _
For upper respiratory tract infections due to streptococci,
pneumococci, no