KETAMINE

Main information

  • Trade name:
  • KETAMINE APOTEX ketamine (as hydrochloride) 200 mg/ 2 mL solution for injection ampoule
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • KETAMINE APOTEX ketamine (as hydrochloride) 200 mg/ 2 mL solution for injection ampoule
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 219040
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

219040

KETAMINE APOTEX ketamine (as hydrochloride) 200 mg/ 2 mL solution for injection ampoule

ARTG entry for

Medicine Registered

Sponsor

Apotex Pty Ltd

Postal Address

PO Box 280,NORTH RYDE BC, NSW, 1670

Australia

ARTG Start Date

12/11/2014

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. KETAMINE APOTEX ketamine (as hydrochloride) 200 mg/ 2 mL solution for injection ampoule

Product Type

Single Medicine Product

Effective date

12/10/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Ketamine is recommended:,1. As the sole anaesthetic agent for diagnostic and surgical procedures that do not require skeletal muscle relaxation.

Ketamine is best suited for short procedures and it can be used with additional doses, for longer procedures;,2. For the induction of anaesthesia prior to

the administration of other general anaesthetic agents;,3. To supplement low-potency agents, such as nitrous oxide.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Ampoule

Glass Type I Clear

36 Months

Store below 30

degrees Celsius

Neither child resistant

closure nor restricted

flow insert

Protect from Light

Pack Size/Poison information

Pack Size

Poison Schedule

(S8) Controlled Drug

Components

1. KETAMINE APOTEX ketamine (as hydrochloride) 200 mg/ 2 mL solution for injection in ampoule

Dosage Form

Injection, solution

Route of Administration

Intravenous

Intramuscular

Visual Identification

Clear colourless to slightly yellow solution.

Active Ingredients

Ketamine hydrochloride

115.34 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 26.11.2017 at 04:03:23 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

Ketamine APOTEX

Solution for Injection

Contains the active ingredient ketamine hydrochloride

Consumer Medicine Information

For a copy of a large print leaflet, Ph: 1800 195 055

What is in this leaflet

Read this leaflet carefully for

information about your medicine.

This leaflet answers some common

questions about ketamine. It does not

contain all the available information.

It does not take the place of talking to

your doctor or pharmacist.

The information in this leaflet was

last updated on the date listed on the

last page. More recent information on

this medicine may be available.

Ask your doctor:

if there is anything you do not

understand in this leaflet,

if you are worried about taking

your medicine, or

to obtain the most up-to-date

information.

You can also download the most up

to date leaflet from

www.apotex.com.au.

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.

Keep this leaflet. You may want to

read it again.

What this medicine is

used for

The name of your medicine is

Ketamine Apotex solution for

injection. It contains the active

ingredient ketamine hydrochloride.

Ketamine is used to make the body

insensitive to surgical treatment. It

may be used in combination with

other medicines to induce

anaesthesia.

This medicine belongs to a group of

medicines called anaesthetics.

It works by stopping the brain from

interpreting messages of pain.

Ask your doctor if you have any

questions about why this medicine

has been prescribed for you. Your

doctor may have prescribed this

medicine for another reason.

This medicine is addictive.

Individuals with a history of drug

abuse or dependence may develop

ketamine dependence and tolerance,

however, addiction is unlikely to

occur when ketamine as

hydrochloride is used as prescribed

for anaesthesia.

This medicine is available only with

a doctor's prescription.

Before you are given

this medicine

When you must not be given

this medicine

You must not be given this

medicine if:

You have or have had any of

the following medical

conditions:

-

poorly controlled blood

pressure

-

severe heart disease

-

heart failure

-

a recent history of stroke

-

recent heart attack

-

brain haemorrhage

-

brain trauma

You are hypersensitive to, or

have had an allergic reaction to

ketamine.

Symptoms of an allergic reaction

may include: cough, shortness of

breath, wheezing or difficulty

breathing; swelling of the face,

lips, tongue, throat or other parts

of the body; rash, itching or hives

on the skin; fainting; or hay

fever-like symptoms.

If you think you are having an

allergic reaction, discuss this

with your doctor or nurse

immediately or go to the

Accident and Emergency

department at the nearest

hospital.

The expiry date (EXP) printed

on the pack has passed.

The packaging is torn, shows

signs of tampering or it does not

look quite right.

KETAMINE APOTEX SOLUTION FOR INJECTION

Before you are given it

Before you are given this medicine,

tell your doctor if:

You have allergies to:

any other medicines

any other substances, such as

foods, preservatives or dyes.

You have or have had any

medical conditions, especially the

following:

heart problems, including heart

attack

dehydration

high blood pressure

breathing problems, including

chest infections and asthma

alcohol intoxication or history of

alcohol abuse

drug abuse or drug dependence

cerebral or head problems

including injury, lesions or

elevated cerebrospinal fluid

pressure

psychiatric disorders (e.g.

schizophrenia, acute psychosis)

overactive thyroid

glaucoma

kidney or liver disease (e.g.

porphyria or cirrhosis)

seizures fits or convulsions.

You are currently pregnant or you

plan to become pregnant, or are

breastfeeding.

You are taking or are planning to

take any other medicines. This

includes vitamins and

supplements that are available

from your pharmacy, supermarket

or health food shop.

Some medicines may interact with

ketamine. These include:

general anaesthetics (medicines

used to put you to sleep during an

operation) and hypnotics (e.g.

thiopental)

barbiturates (used to treat

epilepsy)

narcotic analgesics (used to

relieve pain)

sedatives or anxiolytic drugs

(medicine used to help relieve

anxiety)

alcohol

benzodiazepines (medicines used

as sedatives or to treat anxiety)

ergometrine (a medicine used

sometimes after giving birth)

thyroxine or thyroid hormones

theophylline, a medicine used for

breathing problems or asthma

antihypertensives (medicine used

to help lower high blood

pressure)

muscle relaxants used in

anaesthesia (atracurium and

tubocurarine).

If you are taking any of these you

may need a different dose or you

may need to take different medicines.

Other medicines not listed above

may also interact with ketamine.

How this medicine is

given

How much is given

Your doctor will decide what dose

you will receive. This depends on

your condition and other factors,

such as your age and other medicines

that are being given.

How it is given

Ketamine is given as an injection into

a muscle, or as a slow injection into a

vein. It must only be given by a nurse

or doctor.

If you receive too much

(overdose)

As ketamine is given to you in a

hospital under the supervision of

your doctor, it is very unlikely that

you will receive an overdose. You

will be closely monitored in

hospital during the early post-

operative period so that any

unwanted side effects can be

treated. However if you experience

severe side effects tell your doctor

immediately.

Symptoms of an overdose may

include the side effects listed below

in the 'Possible Side Effects' section

but are usually of a more severe

nature.

In the case an overdose,

immediately telephone your doctor

or the Poisons Information Centre

(Tel: 13 11 26 in Australia) for

advice. Alternatively, go to the

Accident and Emergency

department at your nearest

hospital.

Do this even if there are no signs of

discomfort or poisoning. You may

need urgent medical attention.

While you are being

given this medicine

Things you must do

Tell any doctor or nurse that have

been given this medicine if:

you are about to be started on any

new medicine

you are pregnant or are planning

to become pregnant

you are breastfeeding or are

planning to breastfeed.

Keep all your doctor's

appointments so that your progress

can be checked.

Things to be careful of

Be careful driving or operating

machinery or engage in hazardous

activities for at least 24 hours after

receiving ketamine.

When ketamine is used on an

outpatient basis, you should not be

released from medical care until

you have completely recovered

from the anaesthesia and you

should then be accompanied by a

responsible adult.

Do not drink alcohol for 24 hours

after you have been given this

medicine.

KETAMINE APOTEX SOLUTION FOR INJECTION

Possible side effects

Tell your doctor or nurse as soon as

possible if you do not feel well when

you are given ketamine or if you

have any questions or concerns.

Ketamine may have unwanted side

effects in a few people.

Do not be alarmed by the following

lists of side effects. You may not

experience any of them. All

medicines can have side effects.

Sometimes they are serious but most

of the time they are not.

Tell your doctor, nurse or

pharmacist if you notice any of the

following:

nausea, vomiting

increased saliva

pain at the injection site.

The above list includes the more

common side effects of your

medicine.

Tell your doctor or nurse as soon

as possible if you notice any of the

following.

These may be serious side effects and

you may need medical attention:

rash

double vision or abnormal eye

movements.

If you experience any of the

following tell your doctor or nurse

immediately or go to the Accident

and Emergency department at

your nearest hospital.

These are very serious side effects

and you may need urgent medical

attention or hospitalisation:

confusion, excitation, irrational

behaviour

hallucinations, vivid imagery,

dream-like states, nightmares

movements resembling seizures

breathing difficulties

elevated blood pressure, rapid

pulse rate, heart palpitations.

Other side effects not listed above

may occur in some patients.

Allergic reactions

If you think you are having an

allergic reaction to ketamine tell

your doctor or nurse immediately

or go to the Accident and

Emergency department at your

nearest hospital.

Symptoms of an allergic reaction

may include some or all of the

following:

cough, shortness of breath,

wheezing or difficulty breathing

swelling of the face, lips, tongue,

throat or other parts of the body

rash, itching or hives on the skin

fainting

hay fever-like symptoms.

Storage and disposal

Storage

Ketamine will be stored in the

pharmacy or on the ward. The

injection is kept in a cool dry place,

protected from light where the

temperature stays below 30°C.

Disposal

Ketamine is used for one dose in one

patient only. Any remaining contents

should be discarded.

Product description

What Ketamine APOTEX

Solution for Injection looks

like

A clear and colourless to slightly

yellow solution, essentially free from

visible particulate matter.

Ingredients

Each ampoule contains 200mg of

ketamine (as hydrochloride) as the

active ingredient.

It also contains the following inactive

ingredient:

Water for injections

This medicine is gluten-free, lactose-

free, sucrose-free, tartrazine-free and

free of other azo dyes.

Australian Registration

Numbers

Ketamine APOTEX 200mg/2mL

solution for injection, 2mL ampoule

pack (type I clear glass).

Available in packages of 5 ampoules:

AUST R 219040.

Sponsor

Apotex Pty Ltd

16 Giffnock Avenue

Macquarie Park NSW 2113

APO and APOTEX are registered

trademarks of Apotex Inc.

This leaflet was last updated in

February 2015

KETAMINE APOTEX SOLUTION FOR INJECTION

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