Ventolin IV

País: Nueva Zelanda

Idioma: inglés

Fuente: Medsafe (Medicines Safety Authority)

Ingredientes activos:

Salbutamol sulfate 1.2 mg/mL Equivalent to 1 mg/ml salbutamol;  

Disponible desde:

GlaxoSmithKline NZ Limited

Designación común internacional (DCI):

Salbutamol sulfate 1.2 mg/mL (Equivalent to 1 mg/ml salbutamol)

Dosis:

5mg/5mL

formulario farmacéutico:

Solution for injection

Composición:

Active: Salbutamol sulfate 1.2 mg/mL Equivalent to 1 mg/ml salbutamol   Excipient: Sodium chloride Sodium hydroxide Sulfuric acid Water for injection

Unidades en paquete:

Ampoule, glass, 10 x5ml, 10 dose units

clase:

Prescription

tipo de receta:

Prescription

Fabricado por:

Cambrex Profarmaco Milano Srl

indicaciones terapéuticas:

Respiratory. Salbutamol is a selective ?2 adrenoceptor agonist indicated for the treatment or prevention of bronchospasm. It provides short acting bronchodilation in reversible airways obstruction due to asthma, chronic bronchitis and emphysema. Broncodilators should not be the only or main treatment in patients with persistent asthma. In patients with persistent asthma unresponsive to salbutamol, treatment with inhaled corticosteroids is recommended to achieve and maintain control. Failing to respond to treatment with salbutamol may signal a need for urgent medical advice or treatment. Relief of severe bronchospasm associated with asthma or bronchitis and for the treatment of status asthmaticus.

Resumen del producto:

Package - Contents - Shelf Life: Ampoule, glass, 10 x5ml - 10 dose units - 48 months from date of manufacture stored at or below 30°C protect from light

Fecha de autorización:

1976-03-15

Ficha técnica

1
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME _ _
VENTOLIN INJECTION 500 micrograms/mL
VENTOLIN SOLUTION FOR INTRAVENOUS INFUSION 5 mg/5 mL.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION _ _
VENTOLIN INJECTION 500 micrograms (0.5mg) in 1 mL (500 micrograms/mL)
is
presented in ampoules of 1 mL each containing 0.5 mg Salbutamol as
Salbutamol
Sulphate, in a sterile isotonic solution adjusted to pH 3.5 with
sulphuric acid._ _
VENTOLIN SOLUTION FOR INTRAVENOUS INFUSION 5 mg in 5 mL (1 mg/mL) is
presented as ampoules of 5_ _mL each containing 5_ _mg Salbutamol as
Salbutamol
Sulphate, in a sterile isotonic solution adjusted to pH 3.5 with
sulphuric acid._ _
The ampoules are of clear, neutral glass and the solution is
colourless or faintly straw
coloured.
For full list of excipients, see section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM _ _
Solution for injection.
4.
CLINICAL PARTICULARS _ _
4.1
THERAPEUTIC INDICATIONS
_RESPIRATORY _
Salbutamol is a selective beta-2 adrenoceptor agonist indicated for
the treatment or
prevention of bronchospasm. It provides short acting bronchodilation
in reversible
airways obstruction due to asthma, chronic bronchitis and emphysema.
Bronchodilators should not be the only or main treatment in patients
with persistent
asthma. In patients with persistent asthma unresponsive to salbutamol,
treatment with
inhaled corticosteroids is recommended to achieve and maintain
control. Failing to
respond to treatment with salbutamol may signal a need for urgent
medical advice or
treatment.
Relief of severe bronchospasm associated with asthma or bronchitis and
for the
treatment of status asthmaticus.
_MANAGEMENT OF PREMATURE LABOUR _
Salbutamol is a selective beta-2 adrenoceptor agonist. At therapeutic
doses it acts on
the beta-2 adrenoceptors in the uterus, with little or no action on
the beta-1
adrenoceptors of the heart.
2
For the management of uncomplicated premature labour between 22 and 37
weeks of
gestation in patients with no medical or obstetric contraindication to
tocolytic therapy.
Treatment sh