QVAR 100 INHALER beclometasone dipropionate 100mcg per actuation pressurised inhalation

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

beclometasone dipropionate, Quantity: 0.1 mg/actuation

Available from:

iNova Pharmaceuticals (Australia) Pty Ltd

Pharmaceutical form:

Inhalation, pressurised

Composition:

Excipient Ingredients: ethanol; norflurane

Administration route:

Inhalation

Units in package:

100 Doses, 200 Doses

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Prophylactic management of asthma.

Product summary:

Visual Identification: Colourless solution.; Container Type: Aerosol Can - Metered Dose; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Registered

Authorization date:

1999-11-23

Patient Information leaflet

QVAR™
_AUTOHALER™ AND INHALER_
(queue-var auto-hailer and queue-var in-hailer)
_Beclometasone dipropionate extrafine aerosol (beck-low-meth-a-zone
die-pro-pee-one-ate)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about QVAR Autohaler
and QVAR Inhaler. It does not
contain all the available information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking QVAR
Autohaler and QVAR Inhaler against
the benefits they expect it will have
for you.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT'S IN QVAR
AUTOHALER AND
QVAR INHALER
The name of your medication is
QVAR Autohaler and QVAR
Inhaler. It contains an active
ingredient called beclometasone
dipropionate. Beclometasone
dipropionate belongs to the
corticosteroid family.
The amount of medicine in each puff
of QVAR 50 Autohaler and QVAR
50 Inhaler is 50 micrograms of
beclometasone dipropionate, and 100
micrograms in each puff of QVAR
100 Autohaler and QVAR 100
Inhaler.
Each QVAR Autohaler and QVAR
Inhaler 200 dose contains at least 200
puffs.
WHAT QVAR
AUTOHALER AND
QVAR INHALER ARE
USED FOR
QVAR Autohaler and QVAR Inhaler
are designed so the medicine can be
inhaled (breathed in) into the lungs to
help manage asthma.
Asthma causes the lining of your
lungs to become inflamed (red and
swollen), making it difficult for you
to breathe.
Beclometasone dipropionate acts
directly on your air passages to
reduce inflammation. This helps to
improve your condition and to
prevent asthma attacks from
occurring.
QVAR Autohaler and QVAR Inhaler
are, therefore, known as a
"PREVENTER" medicine.
IT MUST BE USED EVERY DAY EVEN IF
YOU HAVE NO SYMPTOMS.
There is no evidence that QVAR
Autohaler and QVAR Inhaler is
addictive.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION –
QVAR™ (BECLOMETASONE DIPROPIONATE) AUTOHALER™ AND
QVAR™ (BECLOMETASONE DIPROPIONATE) INHALER
1
NAME OF THE MEDICINE
Beclometasone dipropionate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Beclometasone dipropionate (BDP) is a white to creamy white, odourless
powder; it is slightly soluble
in water, very soluble in chloroform and freely soluble in acetone and
alcohol. QVAR also contains
ethanol and norflurane (HFA-134a), a propellant which does not contain
chlorofluorocarbons (CFCs).
Excipients with known effects: ethanol (alcohol) 11.85 % v/v.
QVAR 50 Inhaler and Autohaler deliver 50 µg of BDP per inhalation.
QVAR 100 Inhaler and Autohaler
deliver 100 µg of BDP per inhalation.
QVAR Autohaler is a breath actuated inhaler which automatically
releases a metered dose of
medication during inhalation through the mouthpiece and overcomes the
need for patients to
coordinate actuation with inspiration. QVAR Inhaler is a conventional
press and breathe metered dose
inhaler (P&B MDI). There are no differences in formulation between the
Autohaler and the Inhaler
products.
QVAR contains BDP in solution, resulting in an extra fine aerosol. The
aerosol droplets of QVAR are on
average much smaller (Mass Median Aerodynamic Diameter (MMAD), MMAD
range 0.8 to 1.2
microns) than the particle sizes delivered by CFC-suspension
formulations (MMAD range 3.5 to 4
microns) or dry powder formulations (MMAD approximately 10 microns) of
BDP. The smaller particle
size for QVAR results in greater deposition in the airways and less
deposition in the oropharynx than
beclometasone products formulated in CFCs.
Radiolabelled deposition studies demonstrated that for QVAR the
majority of BDP (>55 % dose ex
actuator) is deposited in the lungs and a small amount (< 35 % dose ex
actuator) is deposited in the
oropharynx. In contrast, approximately 4-7 % dose from the actuator of
BDP formulated in
chlorofluorocarbons (CFC-BDP) is deposited in the lungs and over 90 %
is deposited in the
oropharynx. The imaging data