Duolin

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Ipratropium bromide monohydrate 525ug equivalent to 500 µg ipratropium bromide anhy./dose; Salbutamol sulfate 3mg equivalent to 2.5 mg salbutamol/dose

Available from:

REX Medical Ltd

INN (International Name):

Ipratropium bromide monohydrate 525 µg (equivalent to 500 µg ipratropium bromide anhy./dose)

Dosage:

500µg/2.5mg per dose

Pharmaceutical form:

Solution for inhalation

Composition:

Active: Ipratropium bromide monohydrate 525ug equivalent to 500 µg ipratropium bromide anhy./dose Salbutamol sulfate 3mg equivalent to 2.5 mg salbutamol/dose Excipient: Purified water Sodium chloride Sulfuric acid

Units in package:

Ampoule, plastic, LDPE, 20 dose units

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Olon SpA

Therapeutic indications:

DUOLIN 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: Ampoule, plastic, LDPE - 20 dose units - 36 months from date of manufacture stored at or below 25°C 0 days opened, use immediately

Authorization date:

2001-07-17

Summary of Product characteristics

NEW ZEALAND DATASHEET
1 PRODUCT NAME
Duolin
®
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Salbutamol / Ipratropium bromide 2.5mg / 500mcg in 2.5ml
3 PHARMACEUTICAL FORM
DUOLIN 2.5ml nebule contains an isotonic, clear, preservative-free
solution for inhalation of
2.5mg salbutamol (equivalent to 3.01mg salbutamol sulphate) and 500
mcg ipratropium
bromide anhydrous (equivalent to 520 mcg ipratropium bromide
monohydrate)
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
DUOLIN
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
DUOLIN inhalation solution in respiratory nebules may be administered
from a suitable
nebuliser or an intermittent positive pressure ventilator.
Adults (including elderly): One nebule as required for the relief of
symptoms or as directed.
Up to three to four nebules daily.
Patients should be advised to consult a doctor or the nearest hospital
immediately in the
case of acute or rapidly worsening dyspnoea if additional inhalations
do not produce an
adequate improvement.
4.3 Contraindications
DUOLIN is contraindicated in patients with hypertrophic obstructive
cardiomyopathy and
tachyarrhythmia and in patients with a history of hypersensitivity to
atropine or its derivatives,
or to any other component of the product.
4.4 Special warnings and precautions for use
In the case of acute, rapidly worsening dyspnoea a doctor should be
consulted immediately.
Immediate
hypersensitivity
reactions
may
occur
after
administration
of
DUOLIN
as
demonstrated
by
rare
cases
of
urticaria,
angioedema,
rash,
bronchospasm
and
oropharyngeal oedema.
Ocular complications:
Eye pain or discomfort, blurred vision, visual halos or coloured
images in association with
red eyes from conjunctival congestion and corneal oedema may be signs
of acute narrow-
angle glaucoma. Should any combination of these symptoms develop,
treatment with miotic
drops should be initiated and specialist a