ADRENALINE-LINK

Main information

  • Trade name:
  • ADRENALINE-LINK 1:10,000 1mg/10mL adrenaline (epinephrine) acid tartrate injection BP pre filled syringe
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ADRENALINE-LINK 1:10,000 1mg/10mL adrenaline (epinephrine) acid tartrate injection BP pre filled syringe
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 210672
  • Last update:
  • 11-11-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

210672

ADRENALINE-LINK 1:10,000 1mg/10mL (as acid tartrate) injection BP pre filled syringe

ARTG entry for

Medicine Registered

Sponsor

Link Medical Products Pty Ltd T/A Link Pharmaceuticals

Postal Address

PO Box 718,Mona Vale, NSW, 1660

Australia

ARTG Start Date

13/11/2013

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. ADRENALINE-LINK 1:10,000 1mg/10mL (as acid tartrate) injection BP pre filled syringe

Product Type

Single Medicine Product

Effective date

25/08/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Adrenaline 1:10,000 is used as an adjunct in the management of cardiac arrest.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Syringe

Glass Type I Clear

15 Months

Store below 25

degrees Celsius

Not recorded

Protect from Light

Pack Size/Poison information

Pack Size

Poison Schedule

10mL x 1

Not scheduled. Not considered by committee

Components

1. Medicine Component

Dosage Form

Injection, solution

Route of Administration

Subcutaneous

Intravenous

Visual Identification

Clear colourless solution free from visible particles

Active Ingredients

adrenaline (epinephrine) acid tartrate

182 microgram/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 10.10.2017 at 07:22:05 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: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

Adrenaline-Link CMI

ADRENALINE-LINK

adrenaline (epinephrine) acid tartrate

Consumer Medicine Information

What is in this leaflet

This leaflet answers some of the

common questions people ask about

Adrenaline-Link. It does not

contain all the information that is

known about Adrenaline-Link.

It does not take the place of talking

to your doctor or pharmacist.

All medicines have risks and

benefits. Your doctor will have

weighed the risks of you using

Adrenaline-Link 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 Adrenaline-Link

is used for

Adrenaline-Link is usually only

given in cases of extreme

emergency.

Adrenaline-Link may be used

following a heart attack, or to make

the heart beat if it has stopped.

Adrenaline-Link is also used in the

emergency treatment of severe

allergic reactions to insect bites or

stings, medicines, foods or other

substances. It may also be given

during acute asthma attacks for

severe breathing difficulties.

In heart conditions, it can help to

restart the heart and stimulates it to

beat more strongly. Adrenaline-

Link also opens up the airways

making it easier to breathe.

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.

Adrenaline-Link is not addictive.

Before you use

Adrenaline-Link

When you must not use it

Adrenaline-Link is an emergency

life-saving product.

However, it should be given with

care if you have an allergy to:

Adrenaline

sodium metabisulfite

or any other ingredients listed

at the end of the 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 use Adrenaline-Link if:

you are pregnant unless your

doctor says so.

Your doctor will discuss the

possible risks and benefits of using

Adrenaline-Link during pregnancy.

you are in labour.

Adrenaline-Link can stop the

contractions in the womb during

labour.

Do not use Adrenaline-Link after

the use-by (expiry) date printed

on the pack or if the packaging is

torn or shows signs of tampering.

If it has expired or is damaged,

return it to your pharmacist for

disposal.

If you are not sure whether you

should start using this medicine,

talk to your doctor.

Before you start to use it

Tell your doctor if you have

allergies to any other medicines,

foods, preservatives or dyes.

Tell your doctor if you have or

have had any of the following

medical conditions:

heart problems

angina or chest pains

high blood pressure

irregular heart rate

high pressure in the eyes

(glaucoma)

diabetes

brain damage

over active thyroid gland

lung disease

stroke

phaeochromocytoma (rare

tumour of the adrenal gland)

Tell your doctor if you are

breastfeeding.

Adrenaline-Link passes into

breastmilk and there is a possibility

that your baby may be affected.

Your doctor can discuss with you

the risks and benefits of using it

during breastfeeding.

Taking other medicines

Tell your doctor or pharmacist if

you are taking any other

medicines including any that you

get without a prescription from

your pharmacy, supermarket or

health food shop.

Some medicines and Adrenaline-

Link may interfere with each other.

These include:

Adrenaline-Link CMI

some medicines used to treat

coughs and colds

medicines used to treat

depression such as monoamine

oxidase inhibitors

medicines which affect

potassium levels such as

diuretics, theophylline

medicines used for high blood

pressure or heart conditions

medicines to treat high blood

sugar

general anaesthetics

These medicines may be affected by

Adrenaline-Link or may affect how

well it works. You may need

different amounts of your

medicines, or you may need to use

different medicines.

Your doctor and pharmacist have

more information on medicines to

be careful with or avoid while using

this medicine.

If you have not told your doctor

about any of these things, tell

them before you are given any

Adrenaline-Link.

How to give

Adrenaline-Link

How to use it

Adrenaline-Link will normally be

given to you by your doctor or by a

specially trained nurse.

If you have to give Adrenaline-

Link, your doctor will have told you

what dose to use.

Follow all

directions given to you by your

doctor carefully.

This may differ from the

information contained in this leaflet.

The injection will usually be given

just under the skin, however it can

also be given into the muscle, or

straight into the vein. Adrenaline-

Link should not be given into the

buttocks.

Children will be given a lower dose

of Adrenaline-Link depending on

their weight.

For patients using the injection

for an allergic reaction

emergency:

If you get an allergic reaction as

described by your doctor, use

Adrenaline-Link immediately.

Keep the medicine ready to use at

all times.

This medicine is for injection only.

If you will be giving yourself or

anybody else injections, make sure

you know how to give them. Ask

your doctor if you are unsure.

If you have to use Adrenaline-Link

in an emergency tell your doctor

immediately, or go to Accident and

Emergency at your nearest hospital.

You may need further medical

treatment.

If you use too much

(overdose)

The doctor or nurse giving you

Adrenaline-Link will be

experienced in its use, so it is

extremely unlikely that you will

be given too much.

However, if you experience any

side effects after being given

Adrenaline-Link, tell your doctor or

nurse immediately.

If you have to give Adrenaline-

Link, make sure you give it

exactly as directed.

This will

make it unlikely that too much will

be given.

Immediately telephone your

doctor or the Poisons Information

Centre (telephone 13 11 26) for

advice or go to Accident and

Emergency at the nearest

hospital, if you think that you or

anyone else may have used too

much Adrenaline-Link. Do this

even if there are no signs of

discomfort or poisoning.

You may need urgent medical

attention.

Symptoms of overdose may include

feeling unwell, flushing or

abnormal heart beats, and

headaches.

While you are using

Adrenaline-Link

Things you must not do

Do not use Adrenaline-Link to

treat any other complaints unless

your doctor tells you to.

Side effects

Tell your doctor or pharmacist as

soon as possible if you do not feel

well while you are being given

Adrenaline-Link.

All medicines can have side effects.

Sometimes they are serious, most of

the time they are not. You may

need medical treatment if you get

some of the side effects.

Do not be alarmed by the

following lists of side effects. You

may not experience any of them.

Ask your doctor or pharmacist to

answer any questions you may

have.

Tell your doctor or nurse if you

notice any of the following and

they worry you:

fear, anxiety, confusion

tenseness

restlessness

headache

tremor

weakness

dizziness

cold hands and feet

nausea and vomiting

difficulty passing urine

These side effects are usually mild.

Tell your doctor immediately or

go to Accident and Emergency at

your nearest hospital if you notice

any of the following:

difficulty in breathing

whiteness, swelling, pain or loss

of feeling at the site of injection

convulsions, fits or seizures

abnormal heart beat or

palpitations

Adrenaline-Link CMI

These are all serious side effects.

You may need urgent medical

attention

Serious side effects are rare.

Tell your doctor or pharmacist if

you notice anything else that is

making you feel unwell.

Other side effects not listed above

may also occur in some people.

After using

Adrenaline-Link

Storage

If you are storing Adrenaline-

Links at home, they should be

stored in the original pack in a

cool dark place where the

temperature stays below 25ºC.

Do not store it or any other

medicine in the bathroom or near

a sink. Do not leave it on a

window sill or in the car.

Heat and

dampness can destroy some

medicines.

Keep it where children cannot

reach it.

A locked cupboard at least one-and-

a-half metres above the ground is a

good place to store medicines.

Disposal

If your doctor tells you to stop

using Adrenaline-Link or the

expiry date has passed, ask your

pharmacist what to do with any

medicine that is left over.

Product description

Adrenaline-Link is a clear,

colourless solution.

Adrenaline-Link 1mg/mL

(Adrenaline 1:1,000) contains

Adrenaline acid tartrate as the

active ingredient, plus

Sodium metabisulfite

Sodium chloride

Sodium hydroxide or

hydrochloric acid for pH

adjustment

Water for Injections.

Adrenaline-Link 1mg/10mL

(Adrenaline 1:10,000) contains

Adrenaline acid tartrate as the

active ingredient, plus

Sodium metabisulfite

Sodium chloride

Sodium citrate dihydrate

Citric acid monohydrate

Hydrochloric acid for pH

adjustment

Water for Injections.

Adrenaline-Link is available in:

1mg/1mL (Adrenaline-Link

1:1,000) packs of 5, 10 and 50*

clear glass ampoules.

1mg/10mL (Adrenaline-Link

1:10,000) in packs of 10 clear glass

ampoules.

1mg/10mL (Adrenaline-Link

1:10,000) Pre-Filled Syringe in a

pack of 1.

(*pack size not marketed in

Australia)

Sponsor

Link Medical Products Pty Ltd

5 Apollo Street

Warriewood

NSW 2102.

Australian Registration Numbers:

1mg/1mL ampoule: AUST R 12048

1mg/10mL ampoule: AUST R

119194

1mg/10mL Pre-Filled Syringe

AUST R 210672

This leaflet was prepared in August

2017.

13-12-2018

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