LIDOCAINE ACCORD 1% lidocaine hydrochloride 100 mg/10 mL injection ampoule

Land: Australien

Sprog: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv bestanddel:

lidocaine hydrochloride, Quantity: 100 mg

Tilgængelig fra:

Accord Healthcare Pty Ltd

Lægemiddelform:

Injection, solution

Sammensætning:

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

Indgivelsesvej:

Intravenous, Infiltration, Epidural, Intrathecal

Enheder i pakken:

20

Recept type:

(S4) Prescription Only Medicine

Terapeutiske indikationer:

Lidocaine Accord solutions are indicated for the production of local or regional anaesthesia by the following techniques: ? infiltration ? intravenous regional anaesthesia ? peripheral nerve block ? epidural block ? subarachnoid block

Produkt oversigt:

Visual Identification: A clear, colourless solution.; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

Autorisation status:

Registered

Autorisation dato:

2019-09-20

Indlægsseddel

Version 1.0
Page 1 of 3
LIDOCAINE ACCORD 1% AND 2%
_Lidocaine (lignocaine) hydrochloride Solution Injection, 10 mg/mL and
20 mg/mL _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some of the
common questions people ask about
Lidocaine Accord. It does not contain
all the information that is known about
Lidocaine Accord.
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 Lidocaine Accord
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 WITH THE MEDICINE.
You may need to read it again.
WHAT LIDOCAINE ACCORD
IS USED FOR
Lidocaine Accord is used to prevent or
relieve pain, but it will not put you to
sleep.
Lidocaine Accord is also used after
surgery to relieve pain. It can also be
used to make childbirth less painful.
Lidocaine Accord belongs to a group of
medicines called local anaesthetics. It
is injected into the body where it makes
the nerves unable to pass messages to
the brain.
Depending on the amount used,
Lidocaine Accord will either totally
stop pain or will cause a partial loss of
feeling.
Lidocaine Accord is sometimes
combined with adrenaline
(epinephrine) to make it last longer.
Adrenaline (epinephrine) makes the
blood vessels at the site of injection
narrower, which keeps the Lidocaine
Accord where it is needed for a longer
time.
Your doctor will have explained why
you are being treated with Lidocaine
Accord and told you what dose you
will be given.
FOLLOW ALL DIRECTIONS GIVEN TO YOU BY
YOUR DOCTOR CAREFULLY.
They may differ from the information
contained in this leaflet.
Your doctor may prescribe this
medicine for another use. Ask your
doctor if you want more information.
Lidocaine Accord is not addictive.
BEFORE YOU ARE GIVEN
LIDOCAINE ACCORD
_WHEN YOU MUST NOT BE _
_GIVEN IT _
IF YOU ARE PREGNANT OR BREASTFEEDING
DO NOT USE LIDOCAINE ACCORD UNLESS
YOUR DO

Produktets egenskaber

Page 1 of 12
AUSTRALIAN PRODUCT INFORMATION
LIDOCAINE ACCORD (LIDOCAINE HYDROCHLORIDE) SOLUTION FOR
INJECTION
1
NAME OF THE MEDICINE
Lidocaine (lignocaine) hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
LIDOCAINE ACCORD 1%
1 mL contains 10 mg lidocaine hydrochloride.
1 ampoule of 2 mL solution for injection contains 20 mg lidocaine
hydrochloride.
1 ampoule of 5 mL solution for injection contains 50 mg lidocaine
hydrochloride.
1 ampoule of 10 mL solution for injection contains 100 mg lidocaine
hydrochloride.
1 vial of 20 mL solution for injection contains 200 mg lidocaine
hydrochloride.
LIDOCAINE ACCORD 2%
1 mL contains 20 mg lidocaine hydrochloride.
1 ampoule of 2 mL solution for injection contains 40 mg lidocaine
hydrochloride.
1 ampoule of 5 mL solution for injection contains 100 mg lidocaine
hydrochloride.
1 ampoule of 10 mL solution for injection contains 200 mg lidocaine
hydrochloride.
1 vial of 20 mL solution for injection contains 400 mg lidocaine
hydrochloride.
For the full list of excipients, see
SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Lidocaine Accord is a clear, colourless solution for injection.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Lidocaine Accord solutions are indicated for the production of local
or regional anaesthesia by the
following techniques:
−
infiltration
−
intravenous regional anaesthesia
−
peripheral nerve block
−
epidural block
−
subarachnoid block.
4.2
D
OSE AND METHOD OF ADMINISTRATION
Lidocaine Accord solutions contain no antimicrobial agent. The product
is for single use in one patient
only. Discard any residue.
The lowest dosage and volume that results in effective anaesthesia
should be used and should be based
on the status of the patient and the type of regional anaesthesia
intended.
Lidocaine should be administered with great caution to patients with
impaired cardiovascular function
as they may be less able to compensate for functional changes
associated with the prolongation of AV
conduction produced by these drugs.
Page 2 of 12
A