Bridgewest LIDOCAINE INJECTION 1% 200 mg/20 mL solution for injection ampoule

Land: Australien

Sprog: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv bestanddel:

lidocaine hydrochloride monohydrate, Quantity: 10 mg/mL

Tilgængelig fra:

Bridgewest Perth Pharma Pty Ltd

Lægemiddelform:

Injection, solution

Sammensætning:

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

Indgivelsesvej:

Intravenous, Epidural, Infiltration

Enheder i pakken:

20mL x 30

Klasse:

Medicine Registered

Recept type:

(S4) Prescription Only Medicine

Terapeutiske indikationer:

Lignocaine is indicated for the 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.

Produkt oversigt:

Visual Identification: Clear colourless solution; Container Type: Ampoule; Container Material: LDPE; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Autorisation status:

Registered

Autorisation dato:

1994-06-22

Indlægsseddel

LIGNOCAINE INJECTION
_lidocaine (lignocaine)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Lignocaine Injection.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have benefits and
risks. Your doctor has weighed the
risks of you taking Lignocaine
Injection against the benefits this
medicine is expected to 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
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET
You may need to read it again.
WHAT LIGNOCAINE
INJECTION IS USED FOR
Lignocaine Injection 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 heart beats to normal.
Lignocaine Injection 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
Injection.
This medicine is available only with
a doctor's prescription.
BEFORE YOU ARE GIVEN
LIGNOCAINE INJECTION
_WHEN YOU MUST NOT BE GIVEN_
_IT_
DO NOT USE LIGNOCAINE INJECTION IF:
•
you have an allergy to lignocaine
or any of the ingredients listed at
the end of this leaflet. 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 have an infection or swelling
where the injection will be given
•
you have blood infections or
disorders
•
you are in severe shock
•
you have low blood pressure
•
you have dis

Produktets egenskaber

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Supersedes: pfpligni10320
Page 1 of 19
AUSTRALIAN
PRODUCT
INFORMATION
–
LIGNOCAINE INJECTION (LIDOCAINE (LIGNOCAINE)
HYDROCHLORIDE MONOHYDRATE)
1.
NAME OF THE MEDICINE
lidocaine (lignocaine) hydrochloride monohydrate
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of Lignocaine Injection contains 10 mg or 20 mg lidocaine
(lignocaine) hydrochloride
monohydrate.
For the full list of excipients, see section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Solution for injection.
Lignocaine Injection is a clear, colourless, sterile, isotonic,
preservative-free solution.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Lidocaine (lignocaine) is indicated 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
DOSAGE
_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.
It is recommended that the dose of lidocaine (lignocaine) at any one
time should not exceed
3 mg/kg. However, the dose administered must be tailored to the
individual patient and
procedure, and the maximum doses here quoted should be used as a guide
only.
Version: pfpligni11220
Supersedes: pfpligni10320
Page 2 of 19
The normal recommended dose of lidocaine (lignocaine) for various
anaesthetic procedures in
an average, healthy 70 kg adult patient are as follows:
Procedure
Concentration (%)
Volume (mL)
Dose (mg)
Infiltrat