KETAMINE-CLARIS

Main information

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

Documents

Localization

  • Available in:
  • KETAMINE-CLARIS 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:
  • 219960
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

219960

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

ARTG entry for

Medicine Registered

Sponsor

Claris Lifesciences Australia Pty Ltd

Postal Address

PO Box 1290,BURWOOD, NSW, 1805

Australia

ARTG Start Date

4/02/2015

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-CLARIS ketamine (as hydrochloride) 200 mg/2 mL solution for injection ampoule

Product Type

Single Medicine Product

Effective date

24/08/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

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

Ketamine-Claris 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

Do not Freeze

Pack Size/Poison information

Pack Size

Poison Schedule

2 mL per ampoule, 10 ampoules

(S8) Controlled Drug

2 mL per ampoule, 25 ampoules

(S8) Controlled Drug

2 ml per ampoule, 5 ampoules

(S8) Controlled Drug

Components

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

Dosage Form

Injection, solution

Route of Administration

Intravenous

Intramuscular

Visual Identification

Clear, colourless to slightly yellow solution essentially free from visible

particle matter.

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 03:05:47 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

Ketamine-Claris

Ketamine(as hydrochloride) 200 mg/2 mL solution for injection

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common questions about Ketamine-Claris. 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 being given

Ketamine-Claris against the benefits they expect it will have for you.

If you have any concerns about being given this medicine, ask your doctor or

pharmacist.

Keep this leaflet. You may need to read it again

What Ketamine-Claris is used for

Ketamine-Claris 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 it for another reason.

This medicine is addictive. Individuals with a history of drug abuse of dependence may

develop ketamine dependence and tolerance, however, addiction is unlikely to occur when

ketamine as hydrochloride is used as prescribed for anaesthesia.

It is available only with a doctor’s prescription.

Before you are given Ketamine-Claris

When you must not be given it

You must not be given Ketamine-Claris if you have an allergy to:

any medicine containing ketamine

any of the ingredients listed at the end of this 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.

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 must not use this medicine after the 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 be given this medicine, talk to your doctor.

Before you are given 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, including a 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

Tell your doctor if you are pregnant or plan to become pregnant or are breast-feeding.

Your doctor can discuss with you the risks and benefits involved.

If you have not told your doctor about any of the above, tell him/her before you are

given Ketamine-Claris.

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 Ketamine-Claris may interfere with each other. These include:

general anaesthetics (medicines used to put you to sleep during an operation) and

hypnotics (e.g. thiopental)

barbiturates (used to treat epilepsy or 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)

These medicines may be affected by ketamine or may affect how well it works. You may

need different amounts of your medicines, or you may need to take different medicines.

Your doctor and pharmacist have more information on medicines to be careful with or avoid

while being treated with this medicine.

If you are not sure whether you should be given ketamine, talk to your doctor or

pharmacist.

How Ketamine-Claris 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-Claris 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-Claris 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 postoperative 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

'Side Effects' section but are usually of a more severe nature.

Ask your doctor or pharmacist if you have any concerns.

In case of overdose, immediately contact the Poisons Information Centre for advice.

(In Australia, call 13 11 26; in New Zealand call 0800 764 766.) or go to Accident and

Emergency at the 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 Ketamine-Claris

Things you must do

Keep all of your doctor’s appointments so that your progress can be checked.

Things to be careful of

Be careful driving or operating machinery or engaging in hazardous activities for at

least 24 hours after receiving Ketamine-Claris.

When Ketamine-Claris 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

.

Side Effects

Tell your doctor or nurse as soon as possible if you do not feel well while you are

being treated with Ketamine-Claris.

Ketamine-Claris may have unwanted side effects in a few people. All medicines can have

side effects. Sometimes they are serious, most of the time they are not. You may need

medical attention 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, nurse or pharmacist if you notice any of the following and they worry

you:

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:

rash

double vision or abnormal eye movements

The above list includes serious side effects which may require medical attention.

If any of the following happen, tell your doctor or nurse immediately or go to Accident

and Emergency at your nearest hospital:

sudden signs of allergy such as rash or hives, swelling of the face, lips or tongue,

wheezing or difficulty breathing

confusion, excitation, irrational behaviour

hallucinations, vivid imagery, dream-like states, nightmares

movements resembling seizures

breathing difficulties

elevated blood pressure, rapid pulse rate, heart palpitations

These are very serious side effects. You may need urgent medical attention or

hospitalisation

Tell your doctor, nurse or pharmacist if you notice anything that is making you feel

unwell. Other side effects not listed above may also occur in some people.

After using Ketamine-Claris

Storage

Ketamine-Claris 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-Claris is used for one dose in one patient only. Any remaining contents should be

discarded.

Product Description

What it looks like

Ketamine-Claris is a clear colourless solution in a glass vial.

Ingredients

Ketamine-Claris contains 200 mg/2 mL of ketamine as hydrochloride as the active

ingredient.

It also contains water for injections.

This medicine does not contain lactose, sucrose, gluten, tartrazine or any other azo dyes.

Supplier / Sponsor

Ketamine-Claris is supplied by:

Australian Sponsor:

Claris Lifesciences Australia Pty Ltd

Suite 1, Level 1,

127-133 Burwood Road

Burwood

NSW 2134

New Zealand Sponsor:

AFT Pharmaceuticals Ltd

Auckland

Ketamine-Claris 200 mg/2 mL, AUST R 219960

5 x 2 mL ampoules

10 x 2 mL ampoules

25 x 2 mL ampoules

This leaflet was updated in January 2014

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EU/3/10/833 (FGK Representative Service GmbH)

EU/3/10/833 (Active substance: Doxorubicin hydrochloride (in heat-sensitive liposomes)) - Transfer of orphan designation - Commission Decision (2019)237 of Wed, 16 Jan 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003113

Europe -DG Health and Food Safety

16-1-2019

EU/3/16/1672 (Celgene Europe B.V.)

EU/3/16/1672 (Celgene Europe B.V.)

EU/3/16/1672 (Active substance: 3-(5-amino-2-methyl-4-oxoquinazolin-3(4H)-yl)piperidine-2,6-dione hydrochloride) - Transfer of orphan designation - Commission Decision (2019)236 of Wed, 16 Jan 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003283

Europe -DG Health and Food Safety

11-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Octenidine (dihydrochloride), decision type: , therapeutic area: , PIP number: P/0240/2018

Opinion/decision on a Paediatric investigation plan (PIP): Octenidine (dihydrochloride), decision type: , therapeutic area: , PIP number: P/0240/2018

Opinion/decision on a Paediatric investigation plan (PIP): Octenidine (dihydrochloride), decision type: , therapeutic area: , PIP number: P/0240/2018

Europe - EMA - European Medicines Agency

13-12-2018


Overview of comments received on 'Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance' (EMA/CHMP/800775/2017)

Overview of comments received on 'Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance' (EMA/CHMP/800775/2017)

Overview of comments received on 'Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance' (EMA/CHMP/800775/2017)

Europe - EMA - European Medicines Agency

13-12-2018


Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance

Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance

Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance

Europe - EMA - European Medicines Agency

11-12-2018


Epinephrine mepivacaine hydrochloride, mepivacaine norepinephrine, mepivacaine: List of nationally authorised medicinal products - PSUSA/00001979/201803

Epinephrine mepivacaine hydrochloride, mepivacaine norepinephrine, mepivacaine: List of nationally authorised medicinal products - PSUSA/00001979/201803

Epinephrine mepivacaine hydrochloride, mepivacaine norepinephrine, mepivacaine: List of nationally authorised medicinal products - PSUSA/00001979/201803

Europe - EMA - European Medicines Agency

28-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): Fenfluramine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0177/2018

Opinion/decision on a Paediatric investigation plan (PIP): Fenfluramine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0177/2018

Opinion/decision on a Paediatric investigation plan (PIP): Fenfluramine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0177/2018

Europe - EMA - European Medicines Agency

28-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): Mexiletine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0210/2018

Opinion/decision on a Paediatric investigation plan (PIP): Mexiletine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0210/2018

Opinion/decision on a Paediatric investigation plan (PIP): Mexiletine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0210/2018

Europe - EMA - European Medicines Agency

28-11-2018

Econor (Elanco GmbH)

Econor (Elanco GmbH)

Econor (Active substance: Valnemulin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)8038 of Wed, 28 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/42/T/54

Europe -DG Health and Food Safety

28-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): ( 2R)-2-Amino-1-[3-( {2-[p-( 4-{3-[ (3,S-diamino-6-chloro-2-pyrazinyl)ca rbonyl ]guanidino }butyl )phenoxy ]ethyl}{ 3-[ ( 2R)-2-am ino-6-guanidinohexanoyla mino] propyl }amino )propylamino ]-6-gu

Opinion/decision on a Paediatric investigation plan (PIP): ( 2R)-2-Amino-1-[3-( {2-[p-( 4-{3-[ (3,S-diamino-6-chloro-2-pyrazinyl)ca rbonyl ]guanidino }butyl )phenoxy ]ethyl}{ 3-[ ( 2R)-2-am ino-6-guanidinohexanoyla mino] propyl }amino )propylamino ]-6-gu

Opinion/decision on a Paediatric investigation plan (PIP): ( 2R)-2-Amino-1-[3-( {2-[p-( 4-{3-[ (3,S-diamino-6-chloro-2-pyrazinyl)ca rbonyl ]guanidino }butyl )phenoxy ]ethyl}{ 3-[ ( 2R)-2-am ino-6-guanidinohexanoyla mino] propyl }amino )propylamino ]-6-guanidino-1-hexanone hexahydrochloride, decision type: , therapeutic area: , PIP number: P/0134/2018

Europe - EMA - European Medicines Agency

28-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): naloxone (hydrochloride), decision type: , therapeutic area: , PIP number: P/0146/2018

Opinion/decision on a Paediatric investigation plan (PIP): naloxone (hydrochloride), decision type: , therapeutic area: , PIP number: P/0146/2018

Opinion/decision on a Paediatric investigation plan (PIP): naloxone (hydrochloride), decision type: , therapeutic area: , PIP number: P/0146/2018

Europe - EMA - European Medicines Agency

27-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): (R)-2-amino-3-phenylpropylcarbamate hydrochloride (solriamfetol), decision type: , therapeutic area: , PIP number: P/0207/2018

Opinion/decision on a Paediatric investigation plan (PIP): (R)-2-amino-3-phenylpropylcarbamate hydrochloride (solriamfetol), decision type: , therapeutic area: , PIP number: P/0207/2018

Opinion/decision on a Paediatric investigation plan (PIP): (R)-2-amino-3-phenylpropylcarbamate hydrochloride (solriamfetol), decision type: , therapeutic area: , PIP number: P/0207/2018

Europe - EMA - European Medicines Agency

26-11-2018

Wakix (Bioprojet Pharma)

Wakix (Bioprojet Pharma)

Wakix (Active substance: Pitolisant hydrochloride) - Centralised - Yearly update - Commission Decision (2018)7974 of Mon, 26 Nov 2018

Europe -DG Health and Food Safety

21-11-2018

EU/3/18/2082 (Takeda Pharma A/S)

EU/3/18/2082 (Takeda Pharma A/S)

EU/3/18/2082 (Active substance: 5-{(1R,2R)-2-[(cyclopropylmethyl)amino]cyclopropyl}-N-(tetrahydro-2H-pyran-4-yl)thiophene-3-carboxamide monohydrochloride) - Orphan designation - Commission Decision (2018)7791 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/040/18

Europe -DG Health and Food Safety

13-11-2018

EU/3/17/1836 (Zogenix GmbH)

EU/3/17/1836 (Zogenix GmbH)

EU/3/17/1836 (Active substance: Fenfluramine hydrochloride) - Transfer of orphan designation - Commission Decision (2018)7576 of Tue, 13 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/233/16/T/01

Europe -DG Health and Food Safety

13-11-2018

EU/3/13/1219 (Zogenix GmbH)

EU/3/13/1219 (Zogenix GmbH)

EU/3/13/1219 (Active substance: Fenfluramine hydrochloride) - Transfer of orphan designation - Commission Decision (2018)7575 of Tue, 13 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/140/13/T/01

Europe -DG Health and Food Safety

1-11-2018

Dexdomitor (Orion Corporation)

Dexdomitor (Orion Corporation)

Dexdomitor (Active substance: dexmedetomidine hydrochloride) - Centralised - Yearly update - Commission Decision (2018)7380 of Thu, 01 Nov 2018

Europe -DG Health and Food Safety

31-10-2018

Evista (Daiichi Sankyo Europe GmbH)

Evista (Daiichi Sankyo Europe GmbH)

Evista (Active substance: Raloxifene hydrochloride) - Centralised - Yearly update - Commission Decision (2018)7342 of Wed, 31 Oct 2018

Europe -DG Health and Food Safety

26-9-2018

Sileo (Orion Corporation)

Sileo (Orion Corporation)

Sileo (Active substance: Dexmedetomidine hydrochloride) - Centralised - Yearly update - Commission Decision (2018)6325 of Wed, 26 Sep 2018

Europe -DG Health and Food Safety

10-8-2018

Brinavess (Correvio)

Brinavess (Correvio)

Brinavess (Active substance: vernakalant hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5523 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1215/T/31

Europe -DG Health and Food Safety

30-7-2018

Segluromet (Merck Sharp and Dohme B.V.)

Segluromet (Merck Sharp and Dohme B.V.)

Segluromet (Active substance: ertugliflozin / metformin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5103 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4314/T/2

Europe -DG Health and Food Safety

30-7-2018

Ceplene (Noventia Pharma Srl)

Ceplene (Noventia Pharma Srl)

Ceplene (Active substance: Histamine dihydrochloride) - Centralised - Renewal - Commission Decision (2018)5116 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/796/R/36

Europe -DG Health and Food Safety