VENTAVIS

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

ILOPROST

متاح من:

BAYER ISRAEL LTD

ATC رمز:

B01AC11

الشكل الصيدلاني:

SOLUTION FOR INHALATION

تركيب:

ILOPROST 0.01 MG/ML

طريقة التعاطي:

INHALATION WITH NEBULISER

نوع الوصفة الطبية :

Required

المصنعة من قبل:

BERLIMED S.A., SPAIN

المجال العلاجي:

ILOPROST

الخصائص العلاجية:

Treatment of patients with primary pulmonary hypertension (PPH) or secondary pulmonary hypertension (SPH) . Due to connective tissue disease or drug - induced, in moderate or severe stages of the disease. In addition, treatment of moderate or severe secondary pulmonary hypertension due to chronic pulmonary thromboembolism, where surgery is not possible.

تاريخ الترخيص:

2020-06-30

نشرة المعلومات

[לוגו מדינת ישראל] [http://www.gov.il/]
[http://www.gov.il/] [לוגו משרד הבריאות] [לוגו משרד
הבריאות] [*5400]
[http://www.health.gov.il/PniyotHazibur/Pages/CallCenter.aspx]
[http://www.health.gov.il/PniyotHazibur/Pages/CallCenter.aspx]
הציבור הרחב עסקים ומוסדות עובדים
בבריאות חפש מידע
תפריט *
[סגירה]
סגור *
דף הבית [http://www.health.gov.il/] *
אודות *
אודות המשרד
[http://www.health.gov.il/About/Pages/about_us.aspx] *
תוכנית עבודה
[http://www.health.gov.il/About/Pages/Agenda.aspx] *
תקציב המשרד
[http://www.health.gov.il/About/Pages/budget.aspx] *
תרשים מבנה ארגוני
[http://www.health.gov.il/About/Pages/OrganizationalStructureDiagram.aspx] *
בעלי תפקידים
[http://www.health.gov.il/About/Phonebook/Pages/PhoneBook.aspx] *
יחידות המשרד
[http://www.health.gov.il/UnitsOffice/Pages/UnitsList.aspx] *
לשכות הבריאות
[http://www.health.gov.il/About/Phonebook/Pages/PhoneBook.aspx?tab=3] *
אמנת שירות
[http://www.health.gov.il/About/sla/Pages/default.aspx] *
אותות ופרסים
[http://www.health.gov.il/About/Awards/Pages/mifal.aspx] *
פרוייקטים תשתיתיים
[http://www.health.gov.il/About/projects/shared_medical_info/Pages/default.aspx] *
דרושים
[http://www.health.gov.il/About/Careers/Pages/default.aspx] *
מנכ"לי משרד הבריאות לדורותיהם
[http://www.health.gov.il/About/Pages/GeneralManegerHistory.aspx] *
יחידות המשרד *
יחידות המשרד
[http://www.health.gov.il/UnitsOffice/Pages/UnitsList.aspx] *
לשכות הבריאות
[http://www.health.gov.il/UnitsOffice/LB/Pages/default.aspx] *
וועדות ומועצות
[http://www.health.gov.il/Services/Committee/Pages/CommitteeList.aspx] *
נושאים *
בריאות הנפש
[http://www.health.gov.il/Subjects/mental_health/Pages/default.aspx] *
בריאות הסביבה
[http://www.health.gov.il/Subjects/Environmental_Health/

خصائص المنتج

1
NAME OF THE MEDICINAL PRODUCT
VENTAVIS
Solution for inhalation
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml solution contains 10 microgram iloprost (as iloprost trometamol).
Each ampoule with 2 ml solution contains 20 microgram iloprost.
Excipient with known effect:
Each ml contains 0.81 mg ethanol 96% (equivalent to 0.75 mg ethanol).
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Solution for inhalation.
Clear, colourless solution.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC
INDICATIONS
Treatment of patients with primary pulmonary hypertension or secondary
pulmonary
hypertension due to connective tissue disease or drug-induced, in
moderate or severe
stages of the disease.
In addition, treatment of moderate or severe secondary pulmonary
hypertension due to
chronic pulmonary thromboembolism, where surgery is not possible.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Ventavis should only be initiated and monitored by a physician
experienced in the
treatment of pulmonary hypertension.
Posology
_ _
_Dose per inhalation session _
At initiation of Ventavis treatment the first inhaled dose should be
2.5 microgram iloprost
as delivered at the mouthpiece of the nebuliser. If this dose is well
tolerated, dosing
should be increased to 5 microgram iloprost and maintained at that
dose. In case of poor
tolerability of the 5 microgram dose, the dose should be reduced to
2.5 microgram
iloprost.
_Daily dose _
The dose per inhalation session should be administered 6 to 9 times
per day according to
the individual need and tolerability.
_ _
_ _
_ _
_ _
_Duration of treatment _
The duration of treatment depends on clinical status and is left to
the physician’s
discretion.
Should
patients
deteriorate
on
this
treatment
intravenous
prostacyclin
treatment should be considered.
_ _
Special populations
_ _
_Hepatic impairment _
Iloprost elimination is reduced in patients with hepatic dysfunction
(see section 5.2).
To avoid undesired accumulation over the day, special caution has to
be exercised with
these patients d