Lignocaine-Claris

Main information

  • Trade name:
  • Lignocaine-Claris lidocaine (lignocaine) hydrochloride 50mg/5 mL solution for injection, ampoule
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Lignocaine-Claris lidocaine (lignocaine) hydrochloride 50mg/5 mL solution for injection, ampoule
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 222077
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

222077

Lignocaine-Claris lidocaine (lignocaine) hydrochloride 50mg/5 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

7/04/2015

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. Lignocaine-Claris lidocaine (lignocaine) hydrochloride 50mg/5 mL solution for injection, ampoule

Product Type

Single Medicine Product

Effective date

23/11/2015

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

For production of local or regional anaesthesia by nerve block, infiltration injection, caudal or other epidural blocks. Treatment or prophylaxis of

life-threatening ventricular arrhythmias, including those associated with myocardial infarction, general anaesthesia in patients predisposed to ventricular

arrhythmias, digitalis intoxication, or following resuscitation from cardiac arrest.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Ampoule

Glass Type I Clear

24 Months

Store below 30

degrees Celsius

Child resistant closure

Do Not Use if there is

Precipitation

Pack Size/Poison information

Pack Size

Poison Schedule

10 ampoules

(S4) Prescription Only Medicine

25 ampoules

(S4) Prescription Only Medicine

5 ampoules

(S4) Prescription Only Medicine

Components

1. Lignocaine-Claris lignocaine hydrochloride 50mg/5 mL solution for injection, ampoule

Dosage Form

Injection, solution

Route of Administration

Intravenous

Infiltration

Epidural

Visual Identification

Clear colourless or almost colourless solution

Active Ingredients

lidocaine (lignocaine) hydrochloride monohydrate

10 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 12:09:11 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

Lignocaine-Claris

Lignocaine hydrochloride 1% and 2% Solution for injection

Consumer Medicine Information

What is in this leaflet

This leaflet answers some of the common questions people ask about Lignocaine-Claris. It does not

contain all the information that is known about Lignocaine-Claris. 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 taking

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

This medicine is likely to be used while you are at the clinic or in hospital. If possible, please read this

leaflet carefully before this medicine is given to you. In some cases this leaflet may be given to you

after the medicine has been used.

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 Lignocaine-Claris is used for

Lignocaine-Claris belongs to two groups of medicines known as local anaesthetics and

antiarrhythmic drugs. Local anaesthetics stop pain and feeling in the area around where it is

injected; and antiarrhythmic drugs work by restoring irregular and/or rapid heartbeats to normal.

Lignocaine-Claris may be used for the management of other conditions that are not mentioned

above. Your doctor will be able to tell you about the specific condition for which you have been

prescribed Lignocaine-Claris.

This medicine is available only with a doctor's prescription

Ligocaine-Claris will not put you to sleep.

Lignocaine-Claris is also used after surgery to relieve pain. It can also be used to make childbirth less

painful.

Depending on the amount used, Lignocaine-Claris will either totally stop pain or will cause a partial

loss of feeling.

Lignocaine hydrochloride is sometimes combined with adrenaline to make it last longer. Adrenaline

makes the blood vessels at the site of injection narrower, which keeps the lignocaine hydrochloride

where it is needed for a longer time.

Lignocaine-Claris is not addictive.

Before you are given it

When you must not be given it:

If you are pregnant or breastfeeding do not use Lignocaine-Claris unless your doctor says so. Ask

your doctor about the risks and benefits of using this medicine while you are pregnant or

breastfeeding.

Lignocaine-Claris has been widely used during pregnancy and there have been no reports of any ill

effects on the baby. It can be used during childbirth.

Your baby can take in very small amounts of lignocaine from breast milk if you are breastfeeding, but

it is unlikely that the amount available to the baby will do any harm.

Lignocaine-Claris will only be used if the solution is clear, the package is undamaged and the use

by (expiry) date marked on the pack has not been passed.

Before you are given it

You must tell your doctor if:

1.

you have any allergies to

any ingredients listed at the end of this leaflet

other local anaesthetics e.g. bupivacaine

any other medicine

other substances such as foods, preservative or dyes

If you have an allergic reaction, you may get a skin rash, hay fever or an asthma attack.

2.

you have any of these medical conditions

problems with your blood pressure or circulation

blood poisoning

problems with the clotting of your blood

nerve problems, e.g. epilepsy

heart, liver or kidney problems

thyroid problems

malignant hyperthermia

diabetes

skin infections

It may not be safe for you to take Lignocaine-Claris if you have any of these conditions.

Taking other medicines

Tell your doctor if you are taking any other medicines, including

ones to control your heart beat e.g. amiodarone

ones for blood pressure (antihypertensives e.g. propranolol, metoprolol, atenolol)

ones for epilepsy or fits e.g. phenytoin, carbamazepine, primidone, phenobarbitone

ones for depression

cimetidine

warfarin (used to stop blood clots)

aspirin, salicylates or other non-steriodal anti-inflammatory drugs (NSAIDs), medicines to

relieve pain and inflammation

some anaesthetics

Some medicines that relax the skeletal muscles e.g. suxamethonium

any medicines that you buy at the chemist, supermarket or health food shop.

These medicines may affect the way Lignocaine-Claris works. Your doctor or pharmacist can tell you

what to do if you are taking any of these medicines.

If you have not told your doctor about any of these things, tell them before you are given any

Lignocaine-Claris.

How Lignocaine-Claris is given

Lignocaine-Claris is given by injection into the skin, directly into the blood stream or into an organ. It

must only be given by a doctor or nurse.

Your doctor will decide what dose and how long you will receive Lignocaine-Claris

If you are given too much (overdose)

This rarely happens as Lignocaine-Claris is administered under the care of a highly trained doctor.

However, if you are given too much lignocaine, you may experience some of the effects listed under

"Side Effects" below.

Your doctor has information on how to recognise and treat an overdose. Ask your doctor if you have

any concerns.

While you are being given Lignocaine-Claris

Things to be careful of

Be careful driving or operating machinery after you have been given Lignocaine-Claris. You may be

drowsy or your reflexes may be slow.

Do not drink alcohol while you are being given Lignocaine-Claris. If you drink alcohol while you are

being given Lignocaine-Claris, your blood pressure may drop making you feel dizzy and faint.

Side Effects

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

being given Lignocaine-Claris.

Like other medicines, Lignocaine-Claris can cause some side effects. If they occur, most are likely to

be minor or temporary. However, some may be serious and need medical attention.

Ask your doctor or pharmacist to answer any questions that you may have.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

Tell your doctor or nurse if you notice any of the following:

weakness, confusion, nervousness, agitation, drowsiness, disorientation or unconsciousness

nausea, vomiting, difficulty in swallowing

headache, dizziness or light-headedness especially if you get up suddenly from a lying or

sitting position

ringing in the ears

slurred speech, sensations of heat and cold

numbness, tremors, twitching

slow heartbeat, low blood pressure

breathing difficulties

blurred or double vision

These are the mild side effects of Lignocaine-Claris.

Serious side effects of Lignocaine-Claris include:

fits or convulsions

skin rash, hives or itching

unconsciousness

breathing problems

low blood pressure

slow heart beat

collapse

You may need urgent medical attention if you get these side effects.

After an epidural injection you may develop a headache or backache which is not related to the

medicine used. These can, on rare occasions, last for some months after the injection is given.

Other side effects not listed above may also occur in some patients. If you notice any other effects,

check with your doctor. Some side effects may only be seen by your doctor.

Storage

Lignocaine-Claris will be stored in the pharmacy or on the ward. The injection is kept in a cool dry

place, where the temperature stays below 30 °C.

Product Description

Lignocaine-Claris is a clear colourless solution, It is available as:

20 mg/2 mL, glass ampoule, packs of 5, 10 and 25 ampoules AUST R 222074

50 mg/5 mL, glass ampoule, packs of 5, 10 and 25 ampoules AUST R 222077

200 mg/20 mL, glass vial, packs of 1 vial, AUST R 222076

40 mg/2 mL, glass ampoule, packs of 5, 10 and 25 ampoules AUST R 222075

100 mg/5 mL, glass ampoule, packs of 5, 10 and 25 ampoules AUST R 222072

400 mg/20 mL, glass vial, packs of 1 vial, AUST R 222073

Ingredients

Lignocaine-Claris contains lignocaine hydrochloride 1% or 2% as the active ingredient. It also

contains sodium chloride and Water for Injections as the excipients. It does not contain a

preservative

Sponsor

Australia

Claris Lifesciences (Australia) Pty Ltd

Suite 1, Level 1,

127-133 Burwood Road

Burwood

NSW 2134

Date of Preparation

13 April 2015

12-6-2018

EU/3/10/811 (Celgene Europe B.V.)

EU/3/10/811 (Celgene Europe B.V.)

EU/3/10/811 (Active substance: N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino] benzenesulfonamide dihydrochloride monohydrate) - Transfer of orphan designation - Commission Decision (2018)3809 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/092/10/T/03

Europe -DG Health and Food Safety

12-6-2018

EU/3/10/810 (Celgene Europe B.V.)

EU/3/10/810 (Celgene Europe B.V.)

EU/3/10/810 (Active substance: N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino] benzenesulfonamide dihydrochloride monohydrate) - Transfer of orphan designation - Commission Decision (2018)3808 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/084/10/T/03

Europe -DG Health and Food Safety

12-6-2018

EU/3/10/794 (Celgene Europe B.V.)

EU/3/10/794 (Celgene Europe B.V.)

EU/3/10/794 (Active substance: N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino] benzenesulfonamide dihydrochloride monohydrate) - Transfer of orphan designation - Commission Decision (2018)3803 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/069/10/T/03

Europe -DG Health and Food Safety