Atrovent

Nazione: Nuova Zelanda

Lingua: inglese

Fonte: Medsafe (Medicines Safety Authority)

Principio attivo:

Ipratropium bromide monohydrate 0.0042 g equivalent to 0.0040 g anhydrous, per container

Commercializzato da:

Boehringer Ingelheim (NZ) Limited

INN (Nome Internazionale):

Ipratropium bromide monohydrate 0.0042 g (Equiv to 0.0040 g anhydrous, per container)

Dosaggio:

20 mcg/dose

Forma farmaceutica:

Aerosol inhaler, metered dose

Composizione:

Active: Ipratropium bromide monohydrate 0.0042 g equivalent to 0.0040 g anhydrous, per container Excipient: Cryofluorane Dichlorodifluoromethane Lecithin Trichlorofluoromethane

Confezione:

Inhaler, metered, 200 doses, 14 g

Classe:

Prescription

Tipo di ricetta:

Prescription

Prodotto da:

Boehringer Ingelheim Pharma GmbH & Co KG

Dettagli prodotto:

Package - Contents - Shelf Life: Inhaler, metered, 200 doses - 14 g - 60 months from date of manufacture stored at or below 25°C

Data dell'autorizzazione:

1979-01-11

Scheda tecnica

Atrovent HFA NZ DS v04
Page 1 of 11
NEW ZEALAND DATA SHEET
1. PRODUCT NAME
ATROVENT aerosol inhaler 20 micrograms/metered dose.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
ATROVENT CFC free pressurised inhalation solution: each actuation
contains 0.021 mg
ipratropium bromide monohydrate corresponding to 0.020 mg ipratropium
bromide anhydrous.
Excipient with known effect:
Contains 8.415 mg of ethanol (anhydrous) in each actuation.
For the full list of excipients, see section 6.1
.
3. PHARMACEUTICAL FORM
Aerosol inhaler, metered dose
ATROVENT is a solution type formulation with the active ingredient,
ipratropium bromide,
completely dissolved in a blend of the propellant, ethanol and water.
It is a clear, colourless
liquid, free from suspended particles filled in a metal container with
a metering valve.
4. CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ATROVENT is indicated as a bronchodilator for maintenance treatment of
bronchospasm
associated
with
chronic
obstructive
pulmonary
disease,
including
chronic
bronchitis,
emphysema and asthma.
4.2
DOSE AND METHOD OF ADMINISTRATION
The dosage should be adapted to the individual requirements and the
patients should be kept
under medical supervision during treatment. Unless otherwise
prescribed, the following
dosages are recommended for adults and children over 12 years of age:
Adults:
Usually 2 metered doses 4 times daily.
Some patients may need up to 4 puffs at a time to obtain maximal
benefit during early treatment. Since a requirement for increasing
doses
suggests
that
additional
therapeutic
modalities
may
be
needed, a total daily dose of 12 puffs should generally not be
exceeded.
Children 6-12 years:
Usually 1 or 2 puffs, 3 times daily.
Children under 6 years: Usually 1 puff, 3 times daily.
In order to ensure that the inhaler is used correctly, administration
should be supervised by an
adult.
Atrovent HFA NZ DS v04
Page 2 of 11
If therapy does not produce a significant improvement or if the
patient`s condition gets worse,
medical advice must be sought in order to de