LIDOCAINE-BAXTER lidocaine (lignocaine) hydrochloride (as monohydrate) 100 mg/5 mL solution for injection ampoule

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

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Patient Information leaflet (PIL)

13-04-2015

Summary of Product characteristics (SPC)

07-05-2020

Public Assessment Report (PAR)

26-11-2017

Active ingredient:

lidocaine hydrochloride monohydrate, Quantity: 106.65 mg (Equivalent: lidocaine hydrochloride, Qty 100 mg)

Available from:

Baxter Healthcare Pty Ltd

INN (International Name):

lidocaine (lignocaine) hydrochloride monohydrate

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: sodium chloride; sodium hydroxide; hydrochloric acid; water for injections

Administration route:

Intravenous, Epidural, Infiltration

Units in package:

5 ampoules, 10 ampoules, 25 ampoules

Prescription type:

(S4) Prescription Only Medicine

Therapeutic 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.

Product summary:

Visual Identification: Clear colourless or almost colourless solution; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Licence status A

Authorization date:

2015-04-07

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

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Summary of Product characteristics

Lidocaine-Baxter (Lidocaine (Lignocaine) hydrochloride (as
monohydrate))
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AUSTRALIAN PRODUCT INFORMATION
LIDOCAINE-BAXTER (LIDOCAINE (LIGNOCAINE)
HYDROCHLORIDE) SOLUTION FOR INJECTION
1
NAME OF THE MEDICINE
Lidocaine (Lignocaine) hydrochloride (as monohydrate)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Lidocaine (Lignocaine) hydrochloride (as monohydrate) 10 mg/mL or 20
mg/mL, solution for
injection
Lidocaine (Lignocaine) hydrochloride (as monohydrate) is a fast acting
local anaesthetic and
antiarrhythmic drug.
Lidocaine-Baxter is a clear, colourless to almost colourless, sterile,
isotonic, preservative-free
solution containing Lidocaine (Lignocaine) hydrochloride (as
monohydrate) 1% or 2%.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Solution for Injection.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC 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.
4.2
DOSE AND METHOD OF ADMINISTRATION
Lidocaine (Lignocaine) Injection is for one dose in one patient only.
Discard any remaining
contents.
As a local anaesthetic for infiltration and nerve block
The dosage varies and depends upon the area to be anaesthetised,
vascularity of the tissues,
number of neuronal segments to be blocked, individual tolerance and
the technique of
anaesthesia. The lowest dose needed to provide effective anaesthesia
should be administered.
For specific techniques and procedures, refer to standard textbooks.
Lidocaine-Baxter (Lidocaine (Lignocaine) hydrochloride (as
monohydrate))
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It is recommended that the dose of lidocaine (lignocaine) at any one
time should not exceed
3mg/kg. However, the dose administered must be tailo

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