CLUSTRAN

Main information

  • Trade name:
  • CLUSTRAN sumatriptan (as succinate) 6 mg/0.5 mL injection syringe with autoinjector
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CLUSTRAN sumatriptan (as succinate) 6 mg/0.5 mL injection syringe with autoinjector
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 209316
  • Last update:
  • 10-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

209316

CLUSTRAN sumatriptan (as succinate) 6 mg/0.5 mL injection syringe with autoinjector

ARTG entry for

Medicine Registered

Sponsor

Sun Pharma ANZ Pty Ltd

Postal Address

Suite 2 02 Level 2 12 Waterloo Road,Macquarie Park, NSW, 2113

Australia

ARTG Start Date

25/06/2014

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. CLUSTRAN sumatriptan (as succinate) 6 mg/0.5 mL injection syringe with autoinjector

Product Type

Single Medicine Product

Effective date

25/01/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

CLUSTRAN injection is indicated for the acute relief of migraine attacks with or without aura., CLUSTRAN injection is also indicated for the acute

treatment of cluster headaches.,There is no information available on the use of sumatriptan in the treatment of basilar or hemiplegic migraine.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Syringe

Glass Type I Clear

3 Years

Store below 25

degrees Celsius

Not recorded

Protect from Light

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

Components

1. CLUSTRAN sumatriptan (as succinate) 6 mg/0.5 mL injection syringe with autoinjector

Dosage Form

Injection, solution

Route of Administration

Subcutaneous

Visual Identification

A Clear colorless to pale yellow solution filled in 1 ml prefilled syringe, in an

autoinjector drug delivery device

Active Ingredients

Sumatriptan

12 mg/mL

© 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 20.10.2017 at 11:15:48 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

Clustran CMI V6

Clustran

Solution for injection in pre-filled pen

(Sumatriptan succinate)

________________________________________________________________________________________________________

Consumer Medicine Information

What is in this leaflet?

Please read this leaflet carefully

before you start using Clustran.

This leaflet answers some common

questions about Clustran. 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 expected benefits of you using

Clustran against the risks this

medicine could 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 is Clustran

used

for?

Clustran contains the active

ingredient sumatriptan succinate.

This medicine belongs to a group of

drugs called serotonin agonists.

Clustran is used to relieve a

migraine attack or cluster headache.

It should not be used to prevent

migraine attacks or cluster

headaches from occurring. Clustran

may be used for migraine

headaches with or without what is

known as 'aura'.

It is thought that migraine headaches

and cluster headaches are due to

widening of certain blood vessels in

the head. Clustran works by making

those vessels normal again and eases

the symptoms of migraine and cluster

headaches.

Your Clustran does not work in other

types of headache which are not a

migraine or a cluster headache.

Clustran is not addictive.

Before you use

Clustran

Do not use if:

You must not use Clustran if:

you have ever had an allergic

reaction to sumatriptan

succinate (See "Side-Effects")

or any of the ingredients

listed toward the end of this

leaflet. (See "Ingredients").

you have or have had:

heart disease or heart attack.

shortness of breath, pain or

tightness in the chest, jaw

or upper arm.

peripheral vascular disease

(pain in the back of the

legs) or are prone to cold,

tingling or numb hands and

feet.

prinzmetal's angina (an

uncommon form of angina

where pain is experienced

at rest rather than during

activity).

angina.

high blood pressure.

stroke.

severe liver disease.

you have taken any of these

medicines in the last 24 hours:

ergotamine (eg. Cafergot)

dihydroergotamine (eg.

Dihydergot)

methysergide (eg. Deseril)

naratriptan (eg Naramig)

zolmitriptan (eg Zomig).

you have taken any of these

medicines in the last two

weeks:

monoamine oxidase inhibitors

(MAOIs), a type of

medicine used for

depression.

SSRIs (Selective Serotonin

Reuptake Inhibitors) or

SNRIs (Serotonin-

Noradrenaline Reuptake

Inhibitors) used to treat

depression.

the expiry date (EXP) printed

on the pack has passed.

the packaging is torn or

shows signs of tampering.

Tell your doctor if:

You must tell your doctor

you are allergic to foods,

dyes, preservatives or any

other medicines, including

any that contain sulphur

(eg. sulphonamide

antibiotics).

you are taking or have taken

any other medicines in the

last two weeks, including

medicines you buy without a

prescription, particularly

herbal preparations

containing St John's Wort

and medicines prescribed for

depression.

you are breastfeeding, pregnant

Clustran CMI V6

or trying to become pregnant.

you have, or have had,

medical conditions like:

liver or kidney

problems.

heart problems. Risk

factors including high

blood pressure, even if

it is under control.

high blood cholesterol

levels, a family history

of heart problems,

obesity, diabetes, you

are male and over 40

years of age, you are

female and have

undergone menopause

or you smoke.

epilepsy, seizures, or

fits or been told that you

are prone to this

problem.

stroke.

How do I use

Clustran?

The first time you ever have

Clustran it must be under the

supervision of a doctor. After this

you must use the injection as your

doctor has instructed.

See the patient Instructions For Use

below or overleaf for information on

how to use the pre-filled pen and how

to discard it. If there is something you

do not understand, ask your doctor or

pharmacist.

How much to use

For adults aged 18 to 65, the dose is

injection

just

under the skin, on the outside of the

thigh.

If the first Clustran helps your

migraine or cluster headache, but the

headache/migraine comes back later,

you may use another Clustran. You

must wait at least one hour between

using the first and second Clustran.

Do not use more than 2 pre-filled

pens (2 x 6 mg) in any twenty-four

hours.

Do not use a second pre-filled pen,

if the first has not provided any

relief from your symptoms. You

may take your usual headache relief

medication provided it does not

contain ergotamine or methysergide.

If you are not sure what to do, ask

your doctor or pharmacist.

If your migraine or cluster headache

is not relieved by Clustran, you may

use Clustran on another occasion to

treat another attack. Provided there

are no side effects, you can use

Clustran to treat at least three

separate migraine or cluster

headache attacks before you and

your doctor decide this medicine is

ineffective for you

How to use it

Clustran should be injected just

under the skin on the outside of

the thigh using the pre-filled pen

(see the patient Instructions For

Use below or overleaf).

When to use it?

It is best to use your Clustran -

when the migraine headache

or cluster headache begins; or

when other symptoms of the

migraine begin, such as nausea

(feeling sick), vomiting or your

eyes becoming sensitive to

light.

If you use Clustran later during

the attack it will still work for

you. Do not use your Clustran

before the above symptoms occur.

What do I do if I use

too much? (Overdose)

Immediately telephone your

doctor or Poisons Information

Centre (telephone Australia 13 11

26 NZ 0800 POISON, 0800 764

766) for advice, if you think you

or anyone else may have used too

many

Clustran pens

, even if there

are no signs of discomfort or

poisoning. You may need urgent

medical attention. If you are not

sure what to do, contact your

doctor or pharmacist.

While you are using

Clustran

Things you must do

Tell your doctor if, for any

reason, you have not taken your

medicine exactly as directed.

Otherwise, your doctor may

think that it is not working and

change your treatment

unnecessarily.

Things you must not do

Do not give this medicine to

anyone else, even if their

symptoms seem similar to yours.

Things to be careful of

As with many other medicines,

Clustran may cause drowsiness

in some people.

Be

careful

driving

or

operating

machinery

until

you

know

how

Clustran

affects you.

If you use Clustran too often, it may

make your headache worse. If this

happens, your doctor may tell you to

stop using Clustran.

What are the

side effects?

Check with your doctor as soon

as possible if you think you are

experiencing any side effects or

allergic reactions due to using

Clustran, even if the problem is

not listed below.

Clustran CMI V6

Like other medicines, Clustran can

cause some side effects. If they

occur, they are most likely to be

minor and temporary. However,

some may be serious and need

medical attention.

A common side-effect with Clustran

is temporary pain at the site of

injection.

Tell your doctor if you experience

any of the following after using

Clustran:

pain, tingling, heat or flushing

in any part of the body.

feelings of sleepiness, dizziness

or tiredness.

nausea (feeling sick) or

vomiting.

a change in blood pressure.

feelings of faintness.

problems with your eyesight.

pain

lower

tummy

bloody

diarrhoea

(ischaemic colitis).

shaking or tremors.

uncontrolled movements.

shortness of breath.

Tell your doctor immediately, or

seek urgent medical attention, and

do not use any more Clustran if

you:

feel heaviness, pressure or

tightness in any part of the

body including the chest or

throat.

feel irregular heartbeats.

have a fit or convulsion.

wheezing, swelling of the

lips/mouth, difficulty in

breathing, hay fever, lumpy rash

("hives") or fainting. These

could be a symptom of an

allergic reaction.

have persistent purple

discolouration and/or pain in

the fingers, toes, ears, nose or

jaw in response to cold.

These side effects are likely to be

serious. Stop using Clustran and

seek medical attention straight

away.

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.

Do not be alarmed by this list of

possible side effects. You may not

experience any of them.

How do I store

Clustran?

Keep your pre-filled pen where

children cannot reach them, such

as in a locked cupboard.

Keep Clustran in a cool, dry place

where

it

stays

below

25°C

and

protect

from

light.

Brief

temperature excursions below and

above 25 °C permitted.

Do not leave in a car, on a window

sill or in a bathroom.

Keep Clustran in its pack until

time to use.

Product is for single use in one

patient only. Discard any residue.

Return any unused or expired

medicine to your pharmacist.

Product description

What Clustran looks like

Clustran is available as a 0.5mL pre-

filled pen which contains 6 mg

sumatriptan (as succinate), in

solution. Clustran is packed in a box

containing either one or two pre-filled

pens. Each Clustran pre-filled pen

contains one dose of 6 mg

sumatriptan.

Not all pack sizes are marketed in

Australia.

Ingredients

Clustran contains the active

ingredient sumatriptan succinate.

Clustran also contains sodium

chloride and water for injections.

Where to go for

further information

Your doctor or pharmacist is the

best person to give you advice on

the treatment of your condition.

You may be able to find general

information about your disease and

its treatment from books, or reliable

websites on the internet.

Pharmaceutical companies are not

in a position to give people medical

advice.

Supplier

Australia:

Sun Pharma ANZ Pty Ltd

Macquarie Park

Sydney NSW 2113

Teva Pharma (New Zealand) Limited

PO Box 128244

Remuera

AUCKLAND 1541

Telephone: 0800 800 097

This leaflet was prepared in October

2017.

The information provided

applies only to: Clustran.

Clustran

Sumatriptan (as succinate)

6 mg/0.5 mL: AUST R 209316

White Needle Shield

protecting grey tip

Plunger

Inspection Window

W TO USE CLUSTRAN

e of Clustran.

ou begin the first step. If you have any questions, ask your doctor or pharmacist.

dicine, through the inspection window (figure 1). It must be a clear, colourless to pale

solution if it looks discoloured or cloudy or contains lumps, flakes, or particles.

shield from the pre‐filled pen until you are ready to inject.

d back into the pre‐filled pen.

emoved NEVER put or press, thumb, fingers, or hand over the exposed grey tip.

Figure 1

PREPARING TO ADMINISTER CLUSTRAN

.

e medicine, through the inspection window (figure 1). It must be a

w solution. Do not inject the solution if it looks discoloured or cloudy

particles.

u will need (Clustran and alcohol or sterile swabs)

(figure 2).

here with an adequate fatty tissue layer.

e skin is tender, bruised, red, or hard.

lcohol or a sterile swab.

re giving the injection.

Figure 2

HOW TO INJECT CLUSTRAN

needle shield by pulling it straight off (Figure 3).

t‐off the white needle shield.

e needle shield back on as this may damage the needle inside.

e blue activation button, place Clustran on the injection site,

ng grey tip (Figure 4)

Pull straight off

White Needle

Shield

GreyTip

Figure 3

an by lifting it straight up from the injection site (Figure 5b).

ver will automatically extend and lock into place to conceal the needle (Figure 5b and

eplace the white needle shield.

tion site. If you notice a spot of blood at the injection site, dab away with a cotton ball or

u may cover the injection site with a bandage.

Clustran pen.

the full dose, DO NOT repeat the injection using a new Clustran pen for at least 1

tran pens in any 24 hour period

rief temperature excursions below and above 25 °C permitted.

Figure 6

Before Use

(With White

Needle Shield)

Before Us

(Without W

Needle Shie