VENTAVIS iloprost 10 microgram/mL solution for inhalation ampoule

Country: Awstralja

Lingwa: Ingliż

Sors: Department of Health (Therapeutic Goods Administration)

Ingredjent attiv:

iloprost, Quantity: 10 microgram/mL

Disponibbli minn:

Bayer Australia Ltd

Għamla farmaċewtika:

Inhalation, conventional

Kompożizzjoni:

Excipient Ingredients: trometamol; hydrochloric acid; ethanol; sodium chloride; water for injections

Rotta amministrattiva:

Inhalation

Unitajiet fil-pakkett:

6 ampoules, 30 ampoules, 300 ampoules, 10 ampoules, 100 ampoules

Tip ta 'preskrizzjoni:

(S4) Prescription Only Medicine

Indikazzjonijiet terapewtiċi:

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.

Sommarju tal-prodott:

Visual Identification: Clear, colourless solution (2 mL); Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 4 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

L-istatus ta 'awtorizzazzjoni:

Licence status A

Data ta 'l-awtorizzazzjoni:

2004-01-21

Fuljett ta 'informazzjoni

VENTAVIS
®
CMI VX1.0
1
VENTAVIS
®
(VEN·TA·VIS)
_iloprost (as trometamol) _
_ _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some common
questions about Ventavis. It does
not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Ventavis
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE.
You may need to read it again.
WHAT VENTAVIS IS
USED FOR
Ventavis is used to treat:

Moderate or severe stages of
pulmonary hypertension,
caused by some defect of the
vessel walls, connective tissue
disease or other medications

Moderate and severe cases of
secondary pulmonary
hypertension that may have
been caused by blood clots in
the lungs, where surgery is
not possible
Pulmonary hypertension is a
condition where blood pressure is
too high in the vessels which
transport blood from the heart to
the lungs.
Ventavis widens blood vessels,
allowing more blood to reach the
lungs and receive oxygen. This
widening results in a decreased
work load on the heart, which in
turn allows the heart to function
more effectively, leading to an
improved supply of oxygen to the
body and reduced strain on the
heart.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS
MEDICINE HAS BEEN PRESCRIBED FOR
YOU.
Your doctor may have prescribed
it for another reason.
BEFORE YOU USE
VENTAVIS
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE VENTAVIS IF YOU HAVE
AN ALLERGY TO:

iloprost, the active ingredient
of Ventavis

any of the ingredients listed at
the end of this leaflet
Some of the symptoms of an
allergic reaction may include:

shortness of breath

wheezing or difficulty
breathing

swelling of the face, lips,
tongue or other parts of the
body

rash, itching or hives on the
skin
DO NOT TAKE VENTAVIS IF YOU HAVE
ANY OF THE FOLLOWING CONDITI

Karatteristiċi tal-prodott

AUSTRALIAN PRODUCT INFORMATION
VENTAVIS ® (ILOPROST) NEBULISER SOLUTION
Ventavis® PI VX1.0; CCDS 13
Page 1 of 15
1 NAME OF THE MEDICINE
Iloprost
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Ventavis 10 microgram/mL nebuliser solution. One ampoule with 2 mL
nebuliser solution
contains 26.8 microgram iloprost trometamol equivalent to 20 microgram
iloprost.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3 PHARMACEUTICAL FORM
Nebuliser 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 DOSE AND METHOD OF ADMINISTRATION
The solution is administered with a suitable inhalation device
(nebuliser) as recommended
in instruction for use and handling. Previous therapy should be
adjusted to individual needs
(see Section 4.5 Interactions with other medicines and other forms of
interactions). In order
for the correct dose of iloprost to be delivered to the patient a
suitable nebuliser must be
used. The HaloLite nebuliser described in the Clinical Trial section
is not currently available
in Australia. Clinical data on the use of other similar nebulisers
with Ventavis is not
available.
Ventavis nebuliser solution should not come into contact with skin and
eyes, oral ingestion
of Ventavis solution should be avoided.
RECOMMENDED DOSE:
•
Adults
At initiation of Ventavis treatment the first inhaled dose should be
2.5 microgram iloprost
(as delivered at the mouthpiece). If this dose is well tolerated,
dosing should be increased
to 5.0 microgram and maintained at that dose. In case of poor
tolerability of the 5.0
microgram dose, the dose should be reduced to 2.5 microgram.
The dose per inhalation session should be administered 6 to 9 times
per day during waking
hour