Min-I-Jet

Main information

  • Trade name:
  • Min-I-Jet adrenaline (epinephrine) 1:10000 1mg/10mL injection pre-filled syringe
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Min-I-Jet adrenaline (epinephrine) 1:10000 1mg/10mL injection pre-filled syringe
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 213983
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

213983

MIN-I-JET ADRENALINE 1:10000 1mg/10mL injection pre-filled syringe

ARTG entry for

Medicine Registered

Sponsor

UCB Australia Pty Ltd T/A UCB Pharma Division of UCB Australia

Postal Address

PO Box 158,MALVERN, VIC, 3144

Australia

ARTG Start Date

16/01/2014

Product category

Medicine

Status

Active

Approval area

Drug Safety Evaluation Branch

Conditions

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

Accepted for Registration or Listing as Goods Currently Supplied at the Commencement of the Therapeutic Goods Act 1989"

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. Min-I-Jet adrenaline (epinephrine) 1:10000 1mg/10mL injection pre-filled syringe

Product Type

Single Medicine Product

Effective date

25/03/2014

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Adjunctive use in the management of cardiac arrest.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Syringe

Glass

12 Months

Store below 25

degrees Celsius

Not recorded

Protect from Light

Pack Size/Poison information

Pack Size

Poison Schedule

10mL X 1

(S3) Pharmacist Only Medicine

Components

1. Medicine Component

Dosage Form

Injection, solution

Route of Administration

Intracardial

Intravenous

Visual Identification

Clear, colourless to slightly yellow liquid

Active Ingredients

adrenaline (epinephrine)

1 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 26.11.2017 at 10:41:24 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

ADRENALINE 1:10,000 INJECTION MINIJET®

Adrenaline 1:10,000

Injection MINIJET®

CONSUMER MEDICINE INFORMATION

You may have been given this product in an emergency situation by a non-medical health professional.

WHAT IS IN THIS

LEAFLET?

This leaflet contains information

about Adrenaline 1:10,000

Injection MINIJET. Please read

it carefully and keep it for future

reference. The information in

this leaflet is only a summary

and is not intended to replace

advice from your doctor.

Please consult your doctor or

pharmacist if you have any

comments or questions.

WHAT IS

ADRENALINE?

Adrenaline is a chemical which

is produced naturally by our

bodies. It helps to regulate

most of the important functions

such as heart rate, blood

pressure and breathing. When

we have a fright or have to fight

or run, extra adrenaline is

released into our blood. As this

adrenaline circulates round the

body it makes our heart beat

faster, helps us to get more air

into our lungs and increases the

blood supply to the muscles.

This helps us to cope with

emergencies and is why we

often get palpitations when we

are frightened. Adrenaline

injections are used to treat

some emergency situations

which can occur in the heart and

lungs. It can only be given by

injection and it acts very quickly.

WHEN IS ADRENALINE

USED?

Adrenaline injections are only

used in medical emergencies.

They are not used as regular

treatment.

Adrenaline 1:10,000 is used in

people whose hearts have

suddenly stopped (cardiac

arrest). The adrenaline can

help to restart the heart and

stimulates it to beat strongly.

As adrenaline is only used in

medical emergencies, the

injection may be given by

paramedical personnel such as

ambulance or nursing staff.

WHO SHOULD NOT

HAVE ADRENALINE

INJECTIONS?

As adrenaline is an emergency

life-saving product it should not

be withheld from anyone who

needs it.

However it should be given

cautiously to elderly people, to

those with high blood pressure,

thyroid problems and some

people with high pressure in the

eye.

Care must also be taken when

giving adrenaline to diabetics,

those with heart disease, people

allergic to adrenaline, persons

with brain damage and persons

who are having an anaesthetic.

BEFORE YOU HAVE

AN ADRENALINE

INJECTION

If you are conscious, you should

tell your doctor if you:

have high blood pressure

have high pressure in the

eye (glaucoma)

have diabetes

have asthma

have heart problems

have thyroid problems

have difficulty urinating or

have prostate problems

have a spinal cord injury or

other condition affecting the

spinal cord

are taking any medicines

and what they are

are pregnant

have ever had an allergic

reaction to sodium

metabisulfite.

SIDE EFFECTS OF

ADRENALINE

As with any medicine, some

side effects may occur. Mild

ADRENALINE 1:10,000 INJECTION MINIJET®

side effects are common with

adrenaline. Common side

effects include: palpitations,

tremor, restlessness, anxiety,

weakness, dizziness, headache,

shortness of breath, cold hands

and feet.

More severe side effects can

occur occasionally and are due

to the effect of adrenaline

stimulating the heart and

increasing the blood pressure.

These side effects can, rarely,

cause a stroke, lung upsets,

severe heart abnormalities or

severe heartbeat irregularities

(see OVERDOSE).

Adrenaline may cut off the blood

supply if given a number of

times in the same area or into

fingers and toes.

Adrenaline may also cause

reduced blood flow and reduce

the amount of oxygen to the

moist linings of the body such

as in the airways. This can lead

to the body’s counter-effect

causing more swelling of the

moist linings.

The reduced blood flow can also

affect the bowels and lead to

death of the tissue, especially if

there is already reduced blood

flow to this area.

Paleness and changes to the

blood are also possible side

effects of Adrenaline.

Always tell your doctor if you

have any unpleasant effects

after receiving Adrenaline

1:10,000 Injection MINIJET.

THE DOSE OF

ADRENALINE

The dose varies depending on

the severity of the condition

being treated but the usual

doses are as follows:

Adrenaline 1:10,000

Adults: 10 mL (1 mg) injected

slowly into a vein and repeated

every 5 minutes if necessary.

Children: 0.1 mL per kg of

bodyweight.

OVERDOSE

Too much adrenaline will give

the severe reactions mentioned

above in SIDE EFFECTS OF

ADRENALINE. Overstimulation

of the heart can cause it to stop

and an abnormal increase in

blood pressure can cause a

stroke or breathing difficulties.

There are medicines available

which will reverse the effects of

adrenaline.

WHAT DOES

Adrenaline 1:10,000

Injection MINIJET

CONTAIN?

Adrenaline 1:10,000 Injection

MINIJET contains adrenaline at

a concentration of 1 mg in each

10 mL (1:10,000) of injection

solution.

Each Adrenaline 1:10,000

Injection MINIJET also contains:

citric acid, sodium citrate,

sodium chloride, sodium

bisulfite, hydrochloric acid,

water.

HOW TO STORE

Adrenaline 1:10,000

Injection MINIJET

Adrenaline 1:10,000 Injection

MINIJET should be protected

from light and stored below

C. They should not be used

after the expiry date on the

package or if the solution is

brown or contains sediment.

WHERE CAN I GET

MORE INFORMATION?

You can get more information

from your doctor or pharmacist.

Sponsor

UCB Pharma

A division of UCB Australia Pty Ltd

Level 1, 1155 Malvern Road

Malvern Vic 3144, Australia

Adrenaline 1:10,000 Injection

MINIJET

AUST R 213983

Date of Preparation

January 2014

MINIJET® is a registered

trademark of International

Medications Systems, Limited.

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