VELETRI

Main information

  • Trade name:
  • VELETRI epoprostenol (as sodium) 1.5 mg powder for injection vial
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • VELETRI epoprostenol (as sodium) 1.5 mg powder for injection vial
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 207547
  • Last update:
  • 10-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

207547

VELETRI epoprostenol (as sodium) 1.5 mg powder for injection vial

ARTG entry for

Medicine Registered

Sponsor

Actelion Pharmaceuticals Australia Pty Ltd

Postal Address

PO Box 372,FRENCHS FOREST, NSW, 1640

Australia

ARTG Start Date

28/02/2014

Product category

Medicine

Status

Active

Approval area

Drug Safety Evaluation Branch

Conditions

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods

Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered

or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Products

1. VELETRI epoprostenol (as sodium) 1.5 mg powder for injection vial

Product Type

Single Medicine Product

Effective date

16/10/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific 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

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Vial

Glass Type I Clear

36 Months

Store below 25

degrees Celsius

Neither child resistant

closure nor restricted

flow insert

Protect from Light

Do not Freeze

Pack Size/Poison information

Pack Size

Poison Schedule

10 mL vial

(S4) Prescription Only Medicine

Components

1. VELETRI epoprostenol (as sodium) 1.5 mg powder for injection vial

Dosage Form

Powder

Route of Administration

Intravenous

Visual Identification

white to off-white lyophilised cake or powder, which on reconstitution is free

from visible particles

Active Ingredients

Epoprostenol sodium

1.593 mg

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 28.11.2017 at 12:24:06 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

Patient Information leaflet

VELETRI

®

(VEL-e-tree)

Epoprostenol Sodium (E-poe-PROST-e-nol SOE-dee-um) 500 mcg /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.

If you use it after the expiry date has

passed, it may not work as well.

Do not use VELETRI if the

packaging is torn or shows signs of

tampering.

If you're not sure whether you should

be using VELETRI, talk to your

doctor.

Before you start to use

VELETRI

You must tell your doctor if:

you are allergic to foods, dyes,

preservatives or any other

medicines.

you are pregnant, trying to

become pregnant, or

breastfeeding.

you are taking any medicine to

prevent blood clots, such as

heparin, warfarin, aspirin or

other anti-inflammatory pain

killers (NSAIDs).

you are taking any medicines

that are used to treat high

blood pressure, or a group of

medicines known as nitrates

that are used to treat angina.

you are taking digoxin, a

medicine used to treat heart

failure.

you are taking any other

medicines, including medicines

you buy without a prescription

from a pharmacy, supermarket

or health food shop.

Some medicines may affect the way

others work. Your doctor or

pharmacist will be able to tell you

what to do when using VELETRI

with other medicines.

How to use VELETRI

VELETRI will be given as an

intravenous infusion only, normally

through a permanently fitted

intravenous catheter (during initial

treatment a 'peripheral line' may be

VELETRI

used which is a non-permanent

catheter). Before VELETRI is used,

it must be dissolved only in sterile

water for injection or Sodium

Chloride 0.9% solution for injection.

How much to use

Initial treatment with VELETRI will

be carried out in a hospital. Your

doctor will start you on an infusion

and slowly increase the dose (every

15 minutes) to find the most effective

or largest dose you can tolerate.

During this part of the treatment you

will also learn about how your body

reacts to VELETRI.

Your doctor will then continue the

infusion based on this dose, and may

increase or decrease your infusion

rate depending on your response to

the treatment. All changes should be

done gradually and under the

direction of a doctor, except in

emergency situations.

If you develop pulmonary oedema

(water on the lungs) during this time,

your doctor may choose not to treat

you with VELETRI.

How to use VELETRI

Your VELETRI infusion will be

given to you as continuous

intravenous infusion only, normally

through a permanently fitted

intravenous catheter through a pump.

There are only certain pumps which

can be used. Your doctor will make

sure you are using the right one.

Your doctor or nurse will have

shown you how to keep your catheter

clean, and the area around it clean

and free from infection. They will

also show you how to prepare and

administer VELETRI and how to

stop treatment if necessary. It is very

important you follow their

instructions carefully.

How long to use it

Use VELETRI for as long as your

doctor advises you to. VELETRI is

generally used over a prolonged

period of time, possibly years. It

should not be stopped suddenly.

Symptoms of suddenly stopping

VELETRI include dizziness,

weakness and difficulty breathing.

If you use too much

(overdose)

As VELETRI has vasodilatory

action, overdose may lead to low

blood pressure, loss of

consciousness, nausea, diarrhoea,

vomiting, facial flushing, headache

and fast heart beat.

In hospital, the effects of VELETRI

are monitored carefully by your

doctor. In the unlikely event that you

receive too much, appropriate action,

such as reducing the dose can be

taken promptly.

If you are using VELETRI at home

and you think you have used too

much, immediately telephone your

doctor or the nearest hospital

casualty department, even if there

are no signs of discomfort. You

may need urgent medical attention.

Keep telephone numbers for these

places handy.

While you are using

VELETRI

Things you must do

Tell your doctor or pharmacist

that you are using VELETRI if you

are about to start on any new

medicines.

Tell your doctor if you become

pregnant or are trying to become

pregnant.

Tell your doctor if, for any reason,

you have not used your medicine

exactly as prescribed.

Otherwise, your doctor may think

that it was not effective and change

your treatment unnecessarily.

Things you must not do

Do not stop using or change the

dose without first checking with

your doctor.

Do not give this medicine to anyone

else, even if their symptoms seem

similar to yours.

Do not use VELETRI to treat any

other complaints unless your

doctor says to.

Things to be careful of

As with many other medicines,

VELETRI may cause dizziness/

drowsiness/tiredness in some people.

Be careful driving or operating

machinery until you know how

VELETRI affects you. If you are

affected, do not drive or operate

machinery.

Side Effects

Check with your doctor as soon as

possible if you have any problems

while taking VELETRI, even if you

do not think the problems are

connected with the medicine or are

not listed in this leaflet.

Like other medicines, VELETRI can

cause side effects in some people.

If you think you are having an

allergic reaction to VELETRI

while you are receiving it, TELL

YOUR DOCTOR

IMMEDIATELY.

Symptoms usually include some or

all of the following:

wheezing

swelling of the lips/mouth

difficulty in breathing

hay fever

lumpy rash ("hives")

fainting

Tell your doctor at once if you

experience any of the following

while you are receiving VELETRI:

fever

fatigue

chills/flu-like symptoms

facial flushing or paleness

fast heart beat

shortness of breath

VELETRI

diarrhoea

feeling or being sick

wind or tummy discomfort

anxiety, nervousness and

agitation

dizziness, especially on standing

headaches

dry mouth

rash

decreased or increased feeling or

sensitivity, especially in the skin

tingling or numbness of the hands

or feet

chest pain and tightness

reddening and pain at the infusion

site

sweating

jaw, muscle and/or back pain

bleeding: any bleeding can be

serious, if this occurs you should

contact your doctor

Do not be alarmed by this list of

possible side effects.

You may not experience any of

them.

This is not a complete list of all

possible side-effects. Others may

occur in some people and there may

be some side-effects not yet known.

Tell your doctor if you notice

anything else that is making you

feel unwell, even if it is not on this

list.

Ask your doctor if you don't

understand anything in this list.

VELETRI may affect your blood

sugar levels, heart rate or blood

pressure during infusion. Your doctor

will monitor these.

It is very important to keep the area

around the intravenous catheter

clean, otherwise infection of the skin

at the site of injection may result,

which can then spread into your

blood (known as septicaemia).

During administration of VELETRI

the intravenous catheter may become

blocked. Tell your doctor or

pharmacist if this happens.

Storing VELETRI

Storage

Keep this medicine where young

children cannot reach it.

A locked cupboard at least one-and-a

half metres above the ground is a

good place to store medicines.

Keep VELETRI powder in a cool,

dry place where it stays below

25°C.

Protect from light by keeping it in

the carton until use.

Do not store VELETRI powder in

a bathroom or near a sink.

Do not leave VELETRI powder in

the car or on window sills.

Do not freeze VELETRI powder at

any time.

Do not use this medicine after the

expiry date which is stated on the

carton after EXP.The expiry date

refers to the last day of that month.

The reconstituted solution should

be immediately further diluted to

the final concentration. VELETRI

diluted to the final concentration in

the drug delivery reservoir as

directed can be stored for up to 8

days at 2° to 8°C. Do not expose

this solution to direct sunlight.

Do not use this medicine if you

notice any particles in the

reconstituted solution.

Product description

What it looks like

VELETRI: A Sterile, lyophilised

white to off-white powder in a clear

glass vial with a rubber stopper and

an aluminium flip-off cap. Each pack

contains one vial. The 500 mcg vial

has a white flip-off cap and the 1.5

mg vial has a red flip-off cap.

Pack size

Each pack contains one vial.

VELETRI - 500 mcg vial of

epoprostenol

VELETRI - 1.5 mg vial of

epoprostenol

Ingredients

Active ingredient:

VELETRI contains the active

ingredient epoprostenol, as the

sodium salt.

Inactive ingredients:

sucrose,

L-arginine,

sodium hydroxide (for pH

adjustment)

Supplier

VELETRI

is supplied in Australia

by Actelion Pharmaceuticals

Australia Pty Limited.

Suite 6, 13b Narabang Way

Belrose NSW 2085

VELETRI

is distributed in NZ by

Pharmacy Retailing (NZ) Ltd t/a

Healthcare Logistics

58 Richard Pearse Drive

Airport Oaks, Auckland NZ.

This leaflet was prepared in

September 2016

VELETRI 500mcg - AUST R

208316

VELETRI 1.5 mg - AUST R 207547

VELETRI

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