DBL™ Aminophylline Injection

País: Nueva Zelanda

Idioma: inglés

Fuente: Medsafe (Medicines Safety Authority)

Ingredientes activos:

Theophylline hydrate 20.63 mg/mL (as 25mg/mL of aminophylline)

Disponible desde:

Pfizer New Zealand Limited

Designación común internacional (DCI):

Theophylline hydrate 20.63 mg/mL (as 25mg/mL of aminophylline)

Dosis:

250 mg/10mL

formulario farmacéutico:

Solution for injection

Composición:

Active: Theophylline hydrate 20.63 mg/mL (as 25mg/mL of aminophylline) Excipient: Edamine as 25mg/mL of aminophylline + extra q.s. to adjust pH (limit NMT 295 mg / g of theophylline) Water for injection

Unidades en paquete:

Ampoule, glass, 5 x 10mL, 50 mL

clase:

Prescription

tipo de receta:

Prescription

Fabricado por:

BASF PharmaChemikalien GmbH & Co KG

indicaciones terapéuticas:

DBL™Aminophylline Injection is indicated for the treatment of reversible bronchospasm associated with chronic bronchitis, emphysema, bronchial asthma and chronic obstructive pulmonary disease. It may also be used for paroxysmal dyspnoea associated with left heart failure

Resumen del producto:

Package - Contents - Shelf Life: Ampoule, glass, 5 x 10mL - 50 mL - 30 months from date of manufacture stored at or below 25°C - Ampoule, glass, 50 x 10mL - 500 mL - 30 months from date of manufacture stored at or below 25°C

Fecha de autorización:

1981-07-09

Ficha técnica

Version: pfdamini11123
Supercedes: pfdamini10422
Page 1 of 23
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
_ _
DBL™ Aminophylline Injection
250 mg/10 mL
Solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Sterile solution of aminophylline (theophylline and ethylenediamine).
Each mL contains 25
mg of aminophylline (equivalent to 20.63 mg of theophylline).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
DBL Aminophylline Injection 250 mg in 10 mL is a clear, colourless,
solution for injection.
The pH of the solution is between 8.8 and 10.0.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
DBL
Aminophylline Injection is indicated for the treatment of reversible
bronchospasm
associated with chronic bronchitis, emphysema, bronchial asthma and
chronic obstructive
pulmonary disease. It may also be used for paroxysmal dyspnoea
associated with left heart
failure.
4.2 DOSE AND METHOD OF ADMINISTRATION
DBL
_ _
Aminophylline Injection may be administered by intravenous infusion,
or by slow
intravenous injection at a rate not exceeding 20 to 25 mg/min.
Recommended doses are given as a guide only. Dosage must be
individualised based on patient
characteristics, clinical response, and steady state theophylline
concentration. Doses should be
calculated on lean (ideal) body weight. Oral theophylline therapy
should be substituted for
intravenous therapy as soon as adequate improvement has been made.
A loading dose is generally administered over 20 to 30 minutes,
followed by a maintenance
dose.
_Adults and children 6 months and over: _
For patients not currently undergoing aminophylline or theophylline
therapy, a dose of 6 mg
aminophylline/kg lean body weight should be infused over 20 to 30
minutes, to provide a peak
Version: pfdamini11123
Supercedes: pfdamini10422
Page 2 of 23
serum theophylline concentration of approximately 10 microgram/mL (55
micromole/L).
For patients currently undergoing aminophylline or theophylline
therapy, a serum theophylline
concentration should be obtained (see Sect