Duolin

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Ipratropium bromide monohydrate 0.021mg equivalent to ipratropium bromide anhydrous 0.020 mg;  ; Salbutamol sulfate 0.12mg equivalent to salbutamol 0.100 mg

Available from:

REX Medical Ltd

INN (International Name):

Ipratropium bromide monohydrate 0.021 mg (equiv. ipratropium bromide anhydrous 0.020 mg)

Dosage:

0.02mg/0.1mg per dose

Pharmaceutical form:

Aerosol inhaler, metered dose

Composition:

Active: Ipratropium bromide monohydrate 0.021mg equivalent to ipratropium bromide anhydrous 0.020 mg   Salbutamol sulfate 0.12mg equivalent to salbutamol 0.100 mg Excipient: Heptafluoropropane Lactose monohydrate

Units in package:

Aerosol, Alu aerosol can with metered dose valve and actuator, 200 dose units

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Neuland Laboratories Limited

Therapeutic indications:

DUOLIN HFA is indicated for the treatment of reversible bronchospasm associated with obstructive airway diseases in patients who require more than a single bronchodilator.

Product summary:

Package - Contents - Shelf Life: Aerosol, Alu aerosol can with dose counter, metered dose valve and actuator - 200 dose units - 24 months from date of manufacture stored at or below 25°C - Aerosol, Alu aerosol can with metered dose valve and actuator - 200 dose units - 24 months from date of manufacture stored at or below 25°C

Authorization date:

2006-07-28

Summary of Product characteristics

1
NEW ZEALAND DATASHEET
1 PRODUCT NAME
Duolin
®
100 mcg / 20 mcg metered dose aerosol inhaler
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Salbutamol 100 mcg / Ipratropium bromide 20 mcg per inhalation.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Duolin Inhaler consists of a white homogenous suspension of micronised
substances in a
CFC-free (HFA-227) propellant mixture filled in an aluminium canister
with a metering valve.
Each metered dose contains salbutamol 100 mcg (equivalent to 120 mcg
salbutamol
sulphate), and ipratropium bromide 20 mcg (equivalent to 21 mcg of
ipratropium bromide
monohydrate). Duolin Inhaler uses a metered dose inhaler that has a
grey actuator and
mouthpiece with a light blue cap. Each inhaler contains 200 doses.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Duolin Inhaler is indicated for the treatment of reversible
bronchospasm associated with
obstructive airway diseases in patients who require more than a single
bronchodilator.
4.2 Dose and method of administration
Adults (including elderly patients): Two inhalations four times daily.
The dose may be
increased as required up to a maximum of 12 inhalations in 24 hours.
Children: There has been no experience with the use of Duolin Inhaler
in children below the
age of 12 years.
Duolin Inhaler has not been studied in patients with hepatic or renal
insufficiency. It should
be used with caution in those patient populations.
In asthma, concomitant anti-inflammatory therapy should be considered.
In patients who find coordination of a pressurised metered-dose
inhaler difficult, a spacer
device may be used with Duolin Inhaler. Please follow the instruction
for use provided with
the spacer.
Patients should be advised to consult a doctor or the nearest hospital
immediately in the
case of acute or rapidly worsening dyspnoea (difficulty in breathing)
if additional inhalations
do not produce an adequate improvement.
4.3 Contraindications
Duolin Inhaler is contraindicated in patients with a history of
hypersensitivity to