SYMBICORT TURBUHALER 804.5 MCGDOSE

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

BUDESONIDE MICRONIZED; FORMOTEROL FUMARATE

متاح من:

ASTRAZENECA (ISRAEL) LTD

ATC رمز:

R03AK07

الشكل الصيدلاني:

POWDER FOR INHALATION

تركيب:

BUDESONIDE MICRONIZED 80 MCG/DOSE; FORMOTEROL FUMARATE 4.5 MCG/DOSE

طريقة التعاطي:

INHALATION

نوع الوصفة الطبية :

Required

المصنعة من قبل:

ASTRA ZENECA AB., SWEDEN

المجموعة العلاجية:

FORMOTEROL AND OTHER DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES

المجال العلاجي:

FORMOTEROL AND BUDESONIDE

الخصائص العلاجية:

Symbicort turbuhaler is indicated in the regular treatment of asthma where use of a combination (inhaled corticosteroid and long acting beta-agonist) is appropriate: - Patients not adequaterly controlled with inhaled corticosteroids and " as needed" inhaled short acting beta2- agonists. - Or patients already adequately controlled on both inhaled corticosteroids and long acting beta2- agonists. NOTE: Symbicort turbuhaler 80/4.5 mcg/dose is not appropriate in patients with severe asthma.

تاريخ الترخيص:

2021-10-31

نشرة المعلومات

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS' REGULATIONS (PREPARATIONS) - 1986
The medicine is dispensed with a doctor’s prescription only
SYMBICORT
®
TURBUHALER
®
80/4.5 mcg/dose
Inhalation powder
Each inhalation contains:
Budesonide micronized 80 micrograms
Formoterol fumarate dihydrate 4.5 micrograms
For inactive ingredients, please refer to Section 6 - "Further
Information". See also
“Important information about some of the ingredients in this
medicine” in section 2.
Each inhaler contains 60 or 120 inhalations.
Read this leaflet carefully in its entirety before using the medicine.
This leaflet
contains concise information about the medicine. If you have further
questions, refer
to the doctor or pharmacist. Keep this leaflet; you may need it again.
This medicine has been prescribed for the treatment of your ailment.
Do not pass it
on to others. It may harm them, even if it seems to you that their
ailment is similar.
1.
WHAT IS THIS MEDICINE INTENDED FOR?
For the treatment of asthma in patients where use of a combination of
inhaled
corticosteroid and long acting beta agonist is appropriate.
This medicine can be prescribed in different ways for different
patients:
•
Symbicort Turbuhaler and a supplementary inhaler – two inhalers for
asthma.
These patients will use a Symbicort Turbuhaler every day, and use the
supplementary inhaler when they need to treat asthma attacks.
•
Symbicort Turbuhaler on its own – one inhaler for asthma. These
patients will
use Symbicort Turbuhaler every day, and use Symbicort Turbuhaler when
they
need to treat asthma attacks.
Therapeutic group
Budesonide - this medicine belongs to a group of medicines called -
corticosteroids.
It works by reducing and preventing swelling and inflammation in your
lungs.
Formoterol fumarate dihydrate – this medicine belongs to a group
called beta-2
agonist/bronchodilator. It works by relaxing the muscles in your
airways and have a
prolonged activity.
2.
BEFORE USING THE MEDICINE
Do not use this medicine if:
You are sensitiv

خصائص المنتج

1. NAME OF THE MEDICINAL PRODUCT
Symbicort

Turbuhaler

160/4.5 micrograms/inhalation, inhalation powder.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each delivered dose (the dose that leaves the mouthpiece) contains:
budesonide micronized 160
micrograms/inhalation and formoterol fumarate dihydrate 4.5
micrograms/inhalation.
EXCIPIENTS WITH KNOWN EFFECT:
Lactose monohydrate 730 micrograms per delivered dose.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Inhalation powder.
White powder.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
ASTHMA
Symbicort Turbuhaler 160/4.5 mcg/dose is indicated in adults and
adolescents (12 years and older),
for the treatment of asthma, to achieve overall asthma control,
including the relief of symptoms and
the reduction of the risk of exacerbations (see Section 4.2 Posology
and Method of administration).
CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
Symbicort Turbuhaler 160/4.5 mcg/dose is indicated in adults, aged 18
years and older, for the
symptomatic treatment of patients with COPD with forced expiratory
volume in 1 second (FEV
1
)<
70% predicted normal (post-bronchodilator) and an exacerbation history
despite regular
bronchodilator therapy (see also section 4.4).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Route of administration: For inhalation use.
POSOLOGY
ASTHMA
Symbicort Turbuhaler can be used according to different treatment
approaches:
A. Symbicort anti-inflammatory reliever therapy (patients with mild
disease).
B. Symbicort maintenance therapy (fixed dose).
C. Symbicort anti-inflammatory reliever plus maintenance therapy.
A. SYMBICORT ANTI-INFLAMMATORY RELIEVER THERAPY (PATIENTS WITH MILD
DISEASE)
Symbicort Turbuhaler 160/4.5 is taken as needed for the relief of
asthma symptoms when they
occur, and as a preventative treatment of symptoms in those
circumstances recognised by the
patient to precipitate an asthma attack. Patients should be advised to
always have Symbicort
Turbuhaler 160/4.5 available for relief of symptoms.
Preventative use