SYMBICORT TURBUHALER 3209 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 320 MCG/DOSE; FORMOTEROL FUMARATE 9 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 320/9 mcg/dose is indicated in adults and adolescents, age 12 -17 for the regular treatment of asthma where use of a combination (inhaled corticosteroid and long acting β2 adrenoceptor-agonist) is appropriate:-Patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short acting β2 adrenoceptor-agonists.Or- Patients already adequately controlled on both inhaled corticosteroids and long acting β2 adrenoceptoragonists.Chronic Obstructive Pulmonary Disease (COPD)Symbicort Turbuhaler 320/9 mcg/dose is indicated in adults, aged 18 years and older, for the symptomatic treatment of patients with COPD with forced expiratory volume in I second (FEV1) < 70% predicted normal (post-bronchodilator) and an exacerbation history despite regular bronchodilator therapy

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
®
320/9 mcg/dose
Inhalation powder
Each inhalation contains:
Budesonide micronized
320 micrograms
Formoterol fumarate dihydrate
9 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 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.
The medicine is not intended for children and adolescents below the
age of 12.
The treatment with Symbicort Turbuhaler 320/9 mcg/dose for patients
who have chronic
obstructive pulmonary disease (COPD) is only intended for adult
patients (aged 18 years
and older).
1.
WHAT IS THIS MEDICINE INTENDED FOR?
Symbicort Turbuhaler 320/9 mcg/dose is an inhaler that is used to
treat asthma in adults
and adolescents aged 12–17 years. This medicine is also used to
treat the symptoms of
Chronic Obstructive Pulmonary Disease (COPD) in adults aged 18 years
and older only.
COPD is a chronic disease characterized by constant disturbance of
airflow into and out
of the lungs, which is often caused by cigarette smoking.
This medicine can be prescribed in different ways for different
patients.
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 muscl

خصائص المنتج

1. NAME OF THE MEDICINAL PRODUCT
Symbicort

Turbuhaler

320 micrograms/9 micrograms/inhalation, inhalation powder.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each delivered dose (the dose that leaves the mouthpiece) contains:
budesonide
micronized 320 micrograms/inhalation and formoterol fumarate dihydrate
9
micrograms/inhalation.
EXCIPIENTS WITH KNOWN EFFECT:
Lactose monohydrate 491 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 Turbohaler 320/9 mcg/dose is indicated in adults and
adolescents, age 12-17
for the regular treatment of asthma where use of a combination
(inhaled corticosteroid
and long acting β
2
adrenoceptor-agonist) is appropriate:
-
Patients not adequately controlled with inhaled corticosteroids and
“as needed”
inhaled short acting β
2
adrenoceptor-agonists.
Or
-
Patients already adequately controlled on both inhaled corticosteroids
and long
acting β
2
adrenoceptor-agonists.
CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
Symbicort Turbohaler 320/9 mcg/dose is indicated in adults, aged 18
years and older, for
the symptomatic treatment of patients with COPD with forced expiratory
volume in I
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 Turbohaler 320/9 mcg/dose is not intended for the initial
management of
asthma. The dosage of the components of Symbicort Turbuhaler 320/9
mcg/dose is
individual and should be adjusted to the severity of the disease. This
should be
considered not only when treatment with combination products is
initiated, but also
when the maintenance dose is adjusted. If an individual patient should
require a
combination of doses other than those available in the combination
inhaler, appropriate
doses