SYMBICORT TURBUHALER 1604.5 MCGDOSE

מדינה: ישראל

שפה: אנגלית

מקור: Ministry of Health

מרכיב פעיל:

BUDESONIDE MICRONIZED; FORMOTEROL FUMARATE

זמין מ:

ASTRAZENECA (ISRAEL) LTD

קוד ATC:

R03AK07

טופס פרצבטיות:

POWDER FOR INHALATION

הרכב:

BUDESONIDE MICRONIZED 160 MCG/DOSE; FORMOTEROL FUMARATE 4.5 MCG/DOSE

מסלול נתינה (של תרופות):

INHALATION

סוג מרשם:

Required

תוצרת:

ASTRA ZENECA AB., SWEDEN

קבוצה תרפויטית:

FORMOTEROL AND OTHER DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES

איזור תרפויטי:

FORMOTEROL AND BUDESONIDE

סממני תרפויטית:

AsthmaSymbicort 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.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 (FEV1) < 70% predicted normal (post-bronchodilator) and an exacerbation history despite regular bronchodilator therapy.

תאריך אישור:

2021-10-31

עלון מידע

BODY TEXT SIZE
7.0 pt
SMALLEST TEXT SIZE
7.0 pt
Profile
Technical Info
N/A
5749
AZL030I
PS23054
10-11-2022
107674972/403011024 0180
Symbicort Leaflet patient
160mcg/4.5mcg IL
SGK is a Matthews International Corporation
Black
P485
Patient Package Insert in Accordance With
the Pharmacists’ Regulations (Preparations) – 1986
The medicine is dispensed with a doctor’s prescription only
Symbicort
®
Turbuhaler
®
160/4.5 mcg/dose
Inhalation powder
Each inhalation contains:
Budesonide micronized
160 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 either 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.
The medicine is not intended for children and adolescents below the
age of 12.
The treatment with Symbicort Turbuhaler 160/4.5 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 160/4.5 mcg/dose is an inhaler 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.
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.
The

מאפייני מוצר

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