EPOPROSTENOL SUN epoprostenol (as sodium) 1.5 mg powder for injection vial

מדינה: אוסטרליה

שפה: אנגלית

מקור: Department of Health (Therapeutic Goods Administration)

מרכיב פעיל:

epoprostenol sodium, Quantity: 1.593 mg (Equivalent: epoprostenol, Qty 1.5 mg)

זמין מ:

Sun Pharma ANZ Pty Ltd

טופס פרצבטיות:

Injection, powder for

הרכב:

Excipient Ingredients: sucrose; sodium hydroxide; glycine

מסלול נתינה (של תרופות):

Intravenous

יחידות באריזה:

1 vial

סוג מרשם:

(S4) Prescription Only Medicine

סממני תרפויטית:

Epoprostenol SUN is indicated for the long-term treatment, via continuous intravenous infusion, in WHO functional Class III or Class IV patients with idiopathic pulmonary arterial hypertension, familial pulmonary arterial hypertension and pulmonary arterial hypertension associated with the scleroderma spectrum of diseases.

leaflet_short:

Visual Identification: White to off white lyophilized cake or powder; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 30 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

מצב אישור:

Registered

תאריך אישור:

2018-07-13

עלון מידע

EPOPROSTENOL SUN
_EPOPROSTENOL SODIUM_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET?
This leaflet answers some common
questions about EPOPROSTENOL
SUN. It does not contain all of 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 using EPOPROSTENOL SUN
against the benefits this medicine is
expected to have for you.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT
EPOPROSTENOL SUN
IS USED FOR
It is used to treat some types of
pulmonary arterial hypertension
(PAH). PAH is characterised by high
blood pressure in the blood vessel that
carries blood from the heart to the
lungs, and increased resistance in the
blood vessels of the lung. The cause
of PAH is not known, however there
are a number of diseases such as
scleroderma that are associated with
PAH. EPOPROSTENOL SUN
belongs to a group of medicines
called prostaglandins.
It works by widening the blood
vessels in the lungs and so lowering
the blood pressure in your lungs
(known as a vasodilator action).
Your doctor may have prescribed it
for another reason.
Ask your doctor if you have any
questions about why
EPOPROSTENOL SUN has been
prescribed for you.
EPOPROSTENOL SUN is not
addictive.
BEFORE YOU USE
EPOPROSTENOL SUN
_WHEN YOU MUST NOT USE IT_
-
DO NOT USE EPOROSTENOL
SUN IF YOU HAVE EVER HAD AN
ALLERGIC REACTION TO EPOPROSTENOL
OR ANY OF THE INGREDIENTS LISTED AT
THE END OF THIS LEAFLET.
Symptoms of an allergic reaction
may be mild or severe. They
usually include some or all of the
following: wheezing, swelling of
the lips/mouth, difficulty in
breathing, hayfever, lumpy rash
("hives") or fainting.
-
DO NOT USE EPOPROSTENOL
SUN IF YOU HAVE HEART DISEASE
WITH SHORTNESS OF BREATH, AND
SWELLING OF THE FEET OR LEGS DUE
TO FLUID BUILD-UP.
-
DO NOT USE EPOPROSTENOL
SUN
AFTER
THE
EXPIRY
DATE
[EXP.] PRINTED ON THE PACK.
If you use it af

מאפייני מוצר

1
AUSTRALIAN PRODUCT INFORMATION EPOPROSTENOL SUN
(EPOPROSTENOL) POWDER FOR INJECTION
1 NAME OF THE MEDICINE
Epoprostenol sodium
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
EPOPROSTENOL SUN for Injection is formulated for intravenous
administration.
EPOPROSTENOL SUN 500 µg powder for injection: Each vial contains 531
µg epoprostenol
sodium equivalent to 500 µg epoprostenol.
EPOPROSTENOL SUN 1.5 mg powder for injection: Each vial contains 1.593
mg epoprostenol
sodium equivalent to 1.5 mg epoprostenol.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3 PHARMACEUTICAL FORM
Powder for injection for intravenous infusion.
Sterile white to off-white lyophilised cake or powder.
The reconstituted solution of EPOPROSTENOL SUN has a pH of 12.0 to
13.2 and is increasingly
unstable at a lower pH (see Instructions for use/handling).
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
EPOPROSTENOL SUN is indicated for the long-term treatment, via
continuous intravenous
infusion, in WHO functional Class III or Class IV patients with:
•
Idiopathic pulmonary arterial hypertension
•
Familial pulmonary arterial hypertension
•
Pulmonary arterial hypertension associated with the scleroderma
spectrum of diseases.
4.2 DOSE AND METHOD OF ADMINISTRATION
GENERAL
EPOPROSTENOL SUN must be reconstituted before use. Any further
dilution must be
2
performed using the recommended solutions. Infusion sets with an
in-line 0.22 micron filter must
be used (see Instructions for use/handling).
Epoprostenol reconstituted solution (pH 12.0 to 13.2) must not be used
with any preparation or
administration
materials
containing
polyethylene
terephthalate
(PET)
or
polyethylene
terephthalate glycol (PETG) (see SECTION 6.2 INCOMPATIBILITIES).
Suitable ambulatory pumps to be used for the administration of
EPOPROSTENOL SUN include:
•
CADD-Legacy® 1
•
CADD-Legacy® PLUS Manufactured by Smiths Medical.
Other pumps may be used depending on suitability.
Pump accessories found compatible with the administration of
EPOPROSTENOL SUN incl