Symbicort Rapihaler 100/6

Quốc gia: New Zealand

Ngôn ngữ: Tiếng Anh

Nguồn: Medsafe (Medicines Safety Authority)

Thành phần hoạt chất:

Budesonide 80ug;  ;  ;  ; Formoterol fumarate 4.5ug;  

Sẵn có từ:

AstraZeneca Limited

INN (Tên quốc tế):

Budesonide 80 µg

Liều dùng:

100/6

Dạng dược phẩm:

Aerosol inhaler, metered dose

Thành phần:

Active: Budesonide 80ug       Formoterol fumarate 4.5ug   Excipient: Apaflurane Macrogol 1000 Povidone

Các đơn vị trong gói:

Inhaler, metered, 120 dose units

Lớp học:

Prescription

Loại thuốc theo toa:

Prescription

Sản xuất bởi:

Aspen Oss B.V

Chỉ dẫn điều trị:

Symbicort Rapihaler 100/6 is indicated in the regular treatment of asthma where use of a combination (inhaled corticosteroid and long-acting beta2-agonist) is appropriate. This includes: · Patients who are not adequately controlled with inhaled corticosteroid therapy and ?as needed? inhaled short-acting beta-2 adrenoceptor agonists. · Patients who are already adequately controlled on regular separate long acting beta-agonist and inhaled corticosteroid therapies.

Tóm tắt sản phẩm:

Package - Contents - Shelf Life: Inhaler, metered, - 120 dose units - 24 months from date of manufacture stored at or below 30°C 3 months opened stored at or below 30°C

Ngày ủy quyền:

1970-01-01

Tờ rơi thông tin

Vannair CMI 040222
Copyright
1(5)
VANNAIR
®
100/6 AND VANNAIR
®
200/6
BUDESONIDE/FORMOTEROL, 100/6 OR 200/6 MICROGRAMS PER DOSE.
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some of the common questions people ask about
VANNAIR. It does not contain
all the information that is known about VANNAIR. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and benefits. Your doctor will have weighed
the risks of you taking VANNAIR
against the benefits they expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR
OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT VANNAIR IS USED FOR
VANNAIR is used to treat the inflammation caused by asthma. It also
widens the airways so that you
find it easier to breathe. To get the best effect, you should use
VANNAIR as prescribed by your doctor,
even when you have no symptoms.
VANNAIR is also used to treat Chronic Obstructive Pulmonary Disease
(COPD). COPD (which
includes chronic bronchitis and emphysema) is a long term lung
disease. There is often permanent
narrowing and persistent inflammation of the airways. Symptoms may
include difficulty in breathing
(breathlessness or wheezing), coughing and increased sputum. VANNAIR
when used as prescribed
will help to control your COPD symptoms (i.e. breathing difficulties).
VANNAIR contains the medicines budesonide and formoterol, which have
different ways of treating
your condition.
Budesonide acts directly on your airways to reduce and prevent this
inflammation.
Formoterol
works by opening your airways, making it easier for you to breathe.
This effect starts
within 1-3 minutes after inhaling the medicine and lasts for up to 12
hours.
When you breathe in
through the mouthpiece of the inhaler, your breath carries the
medicine to your lungs. See the
VANNAIR instructions in the pack.
Asthma: Using VANNAIR regularly will help prevent asthma attacks and
make it easier to breathe
normally. It is not u

Đặc tính sản phẩm

V
ANNAIR
Data Sheet 161221
Copyright
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
V
ANNAIR
®
100/6, metered aerosol inhaler
V
ANNAIR
®
, 200/6, metered aerosol inhaler
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
V
ANNAIR
is a pressurised metered dose inhaler (pMDI) in the following
strengths:

V
ANNAIR
®
100/6:
Each delivered dose (the dose that leaves the mouthpiece) contains as
active constituents: budesonide 80 micrograms / inhalation and
formoterol fumarate
dihydrate 4.5 micrograms/inhalation.

V
ANNAIR
®
200/6:
Each delivered dose (the dose that leaves the mouthpiece) contains as
active constituents: budesonide 160 micrograms / inhalation and
formoterol fumarate
dihydrate 4.5 micrograms/inhalation.
To avoid confusion, V
ANNAIR
is labelled as metered dose like S
YMBICORT
T
URBUHALER
®
. The
following table gives the corresponding dose delivered to the patient.
TABLE 1
V
ANNAIR
METERED DOSE (ΜG)
CORRESPONDING DOSE DELIVERED TO
PATIENT (ΜG)*
BUDESONIDE
FORMOTEROL
BUDESONIDE
FORMOTEROL
100/6
100
6
80
4.5
200/6
200
6
160
4.5
_* doses referred to in Symbicort publications_
Formoterol fumarate dihydrate is hereafter referred to as formoterol.
For the full list of excipients see section 6.1.
3.
PHARMACEUTICAL FORM
Metered aerosol inhaler
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ASTHMA
V
ANNAIR
100/6
AND
200/6 are indicated in the regular treatment of asthma where use of a
combination (inhaled corticosteroid and long-acting beta-2-agonist) is
appropriate.
This
includes:
V
ANNAIR
Data Sheet 040222
2

Patients who are not adequately controlled with inhaled corticosteroid
therapy and “as
needed” inhaled short-acting beta-2 adrenoceptor agonists.

Patients who are already adequately controlled on regular separate
long acting beta-
agonist and inhaled corticosteroid therapies.
CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
V
ANNAIR
200/6 is indicated for the symptomatic treatment of moderate to severe
COPD (pre-
bronchodilator FEV
1
≤50% predicted normal) in adults with frequent symptoms despit