Ospamox Paediatric Drops

Šalis: Naujoji Zelandija

kalba: anglų

Šaltinis: Medsafe (Medicines Safety Authority)

Veiklioji medžiaga:

Amoxicillin trihydrate 114.8 mg/mL equivalent to Amoxycillin 100 mg/mL (871 µg per mg trihydrate)

Prieinama:

Sandoz New Zealand Limited

INN (Tarptautinis Pavadinimas):

Amoxicillin trihydrate 114.8 mg/mL (=Amoxycillin 100 mg/mL; 871 µg per mg trihydrate)

Dozė:

125 mg/1.25mL

Vaisto forma:

Granules for oral suspension

Sudėtis:

Active: Amoxicillin trihydrate 114.8 mg/mL equivalent to Amoxycillin 100 mg/mL (871 µg per mg trihydrate) Excipient: Guar gum Passionfruit Flavour PHP-072030 Raspberry flavour 501183 TP0551 Saccharin sodium Simeticone Sodium benzoate Sodium citrate Strawberry flavour 052303 BP0551 Sucrose

Vienetai pakuotėje:

Bottle, glass, amber P/E cap + dosing syringe, 30 mL

Klasė:

Prescription

Recepto tipas:

Prescription

Pagaminta:

Sandoz Industrial Products SA

Produkto santrauka:

Package - Contents - Shelf Life: Bottle, glass, amber P/E cap + dosing syringe - 30 mL - 3 years unopened stored at or below 25°C 14 days reconstituted stored at or below 25°C

Leidimo data:

2000-05-18

Prekės savybės

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