BRICALIN TURBUHALER

מדינה: ישראל

שפה: אנגלית

מקור: Ministry of Health

מרכיב פעיל:

TERBUTALINE SULFATE

זמין מ:

TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL

קוד ATC:

R03AC03

טופס פרצבטיות:

POWDER FOR INHALATION

הרכב:

TERBUTALINE SULFATE 0.5 MG/DOSE

מסלול נתינה (של תרופות):

INHALATION

סוג מרשם:

Required

תוצרת:

TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL

קבוצה תרפויטית:

TERBUTALINE

איזור תרפויטי:

TERBUTALINE

סממני תרפויטית:

For the relief of bronchospasm in patients with reversible onbstructive airway disease, including asthma, chronic bronchitis and emphysema.

תאריך אישור:

2023-08-31

מאפייני מוצר

BRICALIN 1. 1. 2015, RH
"רשואו קדבנ ונכותו תואירבה דרשמ י"ע
עבקנ הז ןולע טמרופ"
רבמצד :רשואמ ןולע .
2014
“This leaflet format has been determined by the Ministry of Health
and the content thereof has been checked and
approved.” Date of approval: December 2014.
SUMMARY OF PRODUCT CHARACTERISTICS
WARNING: TOCOLYSIS
ORAL TERBUTALINE SULFATE HAS NOT BEEN APPROVED FOR AND SHOULD NOT BE
USED FOR ACUTE OR
MAINTENANCE TOCOLYSIS. IN PARTICULAR, TERBUTALINE SULFATE SHOULD NOT
BE USED FOR MAINTENANCE
TOCOLYSIS IN THE OUTPATIENT OR HOME SETTING.
DURING
PREGNANCY,
SERIOUS
ADVERSE
REACTIONS,
INCLUDING
DEATH,
HAVE
BEEN
REPORTED
AFTER
ADMINISTRATION OF TERBUTALINE SULFATE TO PREGNANT WOMEN. IN THE
MOTHER, THESE ADVERSE REACTIONS
INCLUDE
INCREASED
HEART
RATE,
TRANSIENT
HYPERGLYCEMIA,
HYPOKALEMIA,
CARDIAC
ARRHYTHMIAS,
PULMONARY
EDEMA
AND
MYOCARDIAL
ISCHEMIA.
INCREASED
FETAL
HEART
RATE
AND
NEONATAL
HYPOGLYCEMIA
MAY
OCCUR
AS
A
RESULT
OF
MATERNAL
ADMINISTRATION.
[SEE
_CONTRAINDICATIONS, _
_TOCOLYSIS_.]
1
NAME OF THE MEDICINAL PRODUCTS
BRICALIN
®
®
®
RESPIRATOR SOLUTION
TURBUHALER
®
®
®
(POWDER FOR INHALATION)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
_BRICALIN RESPIRATOR SOLUTION: _
Each ml contains: Terbutaline sulfate 10 mg
_BRICALIN TURBUHALER_
Terbutaline Sulphate 0.5mg/dose.
For excipients see Section 6.1.
3
PHARMACEUTICAL FORM
Bricalin Respirator Solution: clear, colorless to faintly yellow
solution.
Bricalin Turbuhaler: white to off white inhalation powder.
Breath-actuated metered dose powder inhaler.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Relief of bronchospasm in patients with reversible obstructive airway
disease including
asthma, chronic bronchitis and emphysema.
BRICALIN RESPIRATOR SOLUTION is especially valuable for the relief of
severe bronchospasm.
BRICALIN 1. 1. 2015, RH Page 2 of 8
2
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_ _
_BRICALIN RESPIRATOR SOLUTION _
The usual dose of terbutaline by wet aerosol is 2-5 mg or up to 10 mg
in severe