Nuelin-SR

Land: Nieuw-Zeeland

Taal: Engels

Bron: Medsafe (Medicines Safety Authority)

Werkstoffen:

Theophylline 350mg;  ; Theophylline 350mg

Beschikbaar vanaf:

iNova Pharmaceuticals (New Zealand) Limited

INN (Algemene Internationale Benaming):

Theophylline 350 mg

Dosering:

350 mg

farmaceutische vorm:

Modified release tablet

Samenstelling:

Active: Theophylline 350mg   Excipient: Cellacefate Lactose monohydrate Magnesium stearate Active: Theophylline 350mg Excipient: Guar gum Magnesium stearate

Eenheden in pakket:

Blister pack, PVC/PVDC, 100 tablets

klasse:

Prescription

Prescription-type:

Prescription

Geproduceerd door:

BASF PharmaChemikalien GmbH & Co KG

Product samenvatting:

Package - Contents - Shelf Life: Blister pack, PVC/PVDC - 100 tablets - 36 months from date of manufacture stored at or below 30°C - Bottle, plastic, HDPE - 100 tablets - 36 months from date of manufacture stored at or below 30°C

Autorisatie datum:

1985-05-03

Productkenmerken

NEW ZEALAND DATA SHEET
NEULIN
TM
-SR
NUELIN-SR
Page 1 of 8
1 PRODUCT NAME
NUELIN-SR 250 mg sustained release tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains theophylline BP 250 mg.
For a full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Sustained release tablet.
White, round, biconvex tablets marked 250 on one face and no markings
on the other face.
4 CLINICAL PARTICULARS
4.1
Therapeutic indications
NUELIN-SR tablets are indicated for the relief and prophylaxis of
reversible bronchospasm
associated with asthma, chronic bronchitis and emphysema.
4.2
Dose and method of administration
Desirable therapeutic levels are considered to be between 10-20 µg/mL
(55-110 µmol/L). Higher
levels may produce toxic effects. Toxic effects may also occur at
therapeutic levels. When
maximum response is required, dose levels should be individually
titrated. Serum theophylline may
be monitored to confirm that levels are within the therapeutic range.
Monitoring is recommended,
in particular when dose levels exceed 1g daily in adults or 24 mg/kg
daily in children.
NUELIN-SR doses should be adjusted for factors known to affect
theophylline clearance (see
sections 4.4 and 4.5).
Dose
Adults: 13 mg/kg per 24 hours.
_Paediatric Population _
Children over 2 years: Starting dose 16 mg/kg every 24 hours to a mean
20 mg/kg every 24
hours.
Children under 2 years: Not to be given except on the advice of a
physician.
Children (from 6 months to 16 years) have a more rapid clearance of
theophylline resulting in
the need for higher per kg doses.
_Special Populations _
Where possible patients should be commenced on a lower dose and
gradually increased to the
maintenance dose to minimise the incidence of side effects. Extra
caution is required with the
elderly as they may have slower clearance rates. Obese patients should
be dosed on the basis of
ideal rather than actual body weight. Smokers often require higher
doses than non-smokers due to
more rapid clearance of theophylline.
_ _
NEW ZEALAND DATA SHEET
NEULIN
TM