VELETRI epoprostenol (as sodium) 1.5 mg powder for injection vial
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
24-08-2020
Summary of Product characteristics
(SPC)
24-08-2020
Public Assessment Report
(PAR)
27-11-2017
Active ingredient:
epoprostenol sodium, Quantity: 1.593 mg (Equivalent: epoprostenol, Qty 1.5 mg)
Available from:
Janssen-Cilag Pty Ltd
INN (International Name):
Epoprostenol sodium
Pharmaceutical form:
Powder
Composition:
Excipient Ingredients: arginine; sodium hydroxide; sucrose
Administration route:
Intravenous
Units in package:
10 mL Vial
Prescription type:
(S4) Prescription Only Medicine
Therapeutic indications:
VELETRI 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
Product summary:
Visual Identification: white to off-white lyophilised cake or powder, which on reconstitution is free from visible particles; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Authorization status:
Licence status A
Authorization date:
2014-02-28
Patient Information leaflet
VELETRI (200804) ACMI
1
VELETRI
®
(VEL-E-TREE)
_Epoprostenol Sodium (E-poe-PROST-e-nol SOE-dee-um) 0.5 mg/1.5 mg
Powder for Injection _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about VELETRI. 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 using this medicine
against the benefits they expect it
will 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 VELETRI IS USED
FOR
VELETRI 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. VELETRI belongs to a
group of medicines called
prostaglandins.
VELETRI 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 however, may prescribe
VELETRI for another purpose.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY IT HAS BEEN
PRESCRIBED FOR YOU.
VELETRI is not addictive.
BEFORE YOU USE
VELETRI
_WHEN YOU MUST NOT USE _
_VELETRI _
DO NOT USE VELETRI 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 VELETRI IF YOU HAVE
HEART DISEASE WITH SHORTNESS OF
BREATH, AND SWELLING OF THE FEET OR
LEGS DUE TO FLUID BUILD-UP.
DO NOT USE VELETRI AFTER THE
EXPIRY DATE [EXP.] PRINTED ON THE
PACK
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Summary of Product characteristics
CCDS 191024
1
VELETRI(200729)API
VELETRI
®
EPOPROSTENOL (AS SODIUM)
AUSTRALIAN PRODUCT INFORMATION
1
NAME OF THE MEDICINE
Epoprostenol (as sodium)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
The reconstituted solution of VELETRI has a pH of 10.8 to 12.0 and is
increasingly unstable at a lower
pH. Its pKa value is 4.8.
One vial of sterile, lyophilised powder containing 0.531 mg
epoprostenol sodium equivalent to 0.5 mg
epoprostenol.
One vial of sterile, lyophilised powder containing 1.593 mg
epoprostenol sodium equivalent to 1.5 mg
epoprostenol.
Refer to Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Powder for injection.
VELETRI is a white to off-white powder that must be reconstituted with
either sterile water for
injection or with sodium chloride 0.9% solution for injection.
VELETRI for Injection is a sterile product, formulated for intravenous
administration.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
VELETRI 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
D
OSE AND METHOD OF ADMINISTRATION
GENERAL
VELETRI must be reconstituted before use. Any further dilution must be
performed using the
recommended solutions. Infusion sets with an in-line 0.22 micron
filter must be used (see Section 4.2
DOSE AND METHOD OF ADMINISTRATION- Instructions for Use/Handling).
Suitable ambulatory pumps to be used for the administration of VELETRI
include:
•
CADD-Legacy® 1
CCDS 191024
2
VELETRI(200729)API
•
CADD-Legacy® PLUS
•
CADD®-Solis VIP (variable infusion profile)
Manufactured by Smiths Medical.
Pump accessories found compatible with the administration of VELETRI
include:
•
CADD disposable Medication Cassette Reservoir - 50 mL; 100 mL from
Smiths Medical.
•
CADD extension set with in-line 0.2 micron filter (CADD extension set
with mal
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