Ventavis

מדינה: האיחוד האירופי

שפה: אנגלית

מקור: EMA (European Medicines Agency)

מרכיב פעיל:

iloprost

זמין מ:

Bayer AG

קוד ATC:

B01AC11

INN (שם בינלאומי):

iloprost

קבוצה תרפויטית:

Antithrombotic agents

איזור תרפויטי:

Hypertension, Pulmonary

סממני תרפויטית:

Treatment of patients with primary pulmonary hypertension, classified as New York Heart Association functional class III, to improve exercise capacity and symptoms.

leaflet_short:

Revision: 30

מצב אישור:

Authorised

תאריך אישור:

2003-09-15

עלון מידע

42
B. PACKAGE LEAFLET
43
PACKAGE LEAFLET: INFORMATION FOR THE USER
VENTAVIS 10 MICROGRAM/ML NEBULISER SOLUTION
iloprost
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, pharmacist or
nurse.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Ventavis is and what it is used for
2.
What you need to know before you use Ventavis
3.
How to use Ventavis
4.
Possible side effects
5.
How to store Ventavis
6.
Contents of the pack and other information
1.
WHAT VENTAVIS IS AND WHAT IT IS USED FOR
WHAT VENTAVIS IS
The active substance of Ventavis is iloprost. It imitates a natural
substance in the body called
prostacyclin. Ventavis inhibits unwanted blocking or narrowing of
blood vessels and allows more
blood to flow through the vessels.
WHAT VENTAVIS IS USED FOR
Ventavis is used to treat moderate cases of primary pulmonary
hypertension (PPH) in adult patients.
PPH is a category of pulmonary hypertension where the cause of the
high blood pressure is not known.
This is a condition where blood pressure is too high in the blood
vessels between the heart and the
lungs.
Ventavis is used to improve exercise capacity (the ability to carry
out physical activity) and symptoms.
HOW VENTAVIS WORKS
Breathing in the mist carries Ventavis to the lungs, where it can work
most effectively in the artery
between heart and lungs. Improved blood flow leads to a better supply
of oxygen to the body and
reduced strain on the heart.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE VENTAVIS
DO NOT USE VENTAVIS
•
IF YOU ARE ALLERGIC
to iloprost or any of the other ingredients of this medicine (listed

מאפייני מוצר

1
_ _
_ _
_ _
_ _
_ _
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Ventavis 10 microgram/ml nebuliser solution
Ventavis 20 microgram/ml nebuliser solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ventavis 10 microgram/ml nebuliser solution
1 ml solution contains 10 microgram iloprost (as iloprost trometamol).
Each ampoule with 1 ml solution contains 10 microgram iloprost.
Each ampoule with 2 ml solution contains 20 microgram iloprost.
Ventavis 20 microgram/ml nebuliser solution
1 ml solution contains 20 microgram iloprost (as iloprost trometamol).
Each ampoule with 1 ml solution contains 20 microgram iloprost.
Excipient with known effect
•
Ventavis 10 microgram/ml:
Each ml contains 0.81 mg ethanol 96% (equivalent to 0.75 mg ethanol)
•
Ventavis 20 microgram/ml:
Each ml contains 1.62 mg ethanol 96% (equivalent to 1.50 mg ethanol).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Nebuliser solution.
Ventavis 10 microgram/ml nebuliser solution
Clear, colourless solution.
Ventavis 20 microgram/ml nebuliser solution
Clear, colourless to slightly yellowish solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of adult patients with primary pulmonary hypertension,
classified as NYHA functional
class III, to improve exercise capacity and symptoms.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
DRUG PRODUCT
SUITABLE INHALATION DEVICE (NEBULISER) TO BE USED
Ventavis 10 microgram/ml
Breelib
I-Neb AAD
Venta-Neb
Ventavis 20 microgram/ml
Breelib
I-Neb AAD
Ventavis should only be initiated and monitored by a physician
experienced in the treatment of
pulmonary hypertension.
3
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 micr