LIDOCAINE NORIDEM 2% lidocaine (lignocaine) hydrochloride 40 mg/2 mL solution for injection ampoule

Land: Australia

Språk: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv ingrediens:

lidocaine hydrochloride monohydrate, Quantity: 42.64 mg (Equivalent: lidocaine hydrochloride, Qty 40 mg)

Tilgjengelig fra:

Interpharma Pty Ltd

Legemiddelform:

Injection, solution

Sammensetning:

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

Administreringsrute:

Intravenous, Epidural, Infiltration, Intrathecal

Enheter i pakken:

5 ampoules

Resept typen:

(S4) Prescription Only Medicine

Indikasjoner:

LIDOCAINE NORIDEM 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 oppsummering:

Visual Identification: Clear, colourless and odourless solution; Container Type: Ampoule; Container Material: PP; Container Life Time: 22 Months; Container Temperature: Store below 25 degrees Celsius

Autorisasjon status:

Registered

Autorisasjon dato:

2022-07-19

Informasjon til brukeren

LIDOCAINE NORIDEM
CMI V1.1 JUL 2022
1
LIDOCAINE NORIDEM
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING LIDOCAINE NORIDEM?
LIDOCAINE NORIDEM contains the active ingredient lidocaine(lignocaine)
hydrochloride. LIDOCAINE NORIDEM is used to prevent
or relieve pain, but it will not put you to sleep.
For more information, see Section 1. Why am I using LIDOCAINE NORIDEM?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE LIDOCAINE NORIDEM?
Do not use if you have ever had an allergic reaction to lidocaine
(lignocaine) hydrochloride or any other local anaesthetics eg.
Bupivacaine or any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
LIDOCAINE NORIDEM?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with LIDOCAINE NORIDEM and affect how it
works.
A list of these medicines is in Section 3. What if I am taking other
medicines?
in the full CMI.
4.
HOW DO I USE LIDOCAINE NORIDEM?
LIDOCAINE NORIDEM will be injected by your doctor into the skin, near
a single nerve, or into an area which contains a large
number of nerves. More information can be found in Section 4. How do I
use LIDOCAINE NORIDEM? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING LIDOCAINE NORIDEM?
THINGS YOU
SHOULD DO
•
Tell your Doctor if you have any of the medical conditions listed in
Section 2 below. It may not be safe
for you to take LIDOCAINE NORIDEM if you have any of these conditions.
THINGS YOU
SHOULD NOT DO
•
Do not drink alcohol while you are being given LIDOCAINE NORIDEM
DRIVING OR USING
MACHINES
•
LIDOCAINE NORIDEM may cause drowsiness and your reflexes may be slow.
DRINKING
ALCOHOL
If you drink alcohol while you are being given LIDOCAINE NOR

Preparatomtale

1
LIDOCAINE NORIDEM PI Version 1.3 May 2022
AUSTRALIAN PRODUCT INFORMATION
LIDOCAINE NORIDEM
(LIDOCAINE HYDROCHLORIDE
SOLUTION FOR INJECTION)
1
NAME OF THE MEDICINE
Lidocaine (lignocaine) hydrochloride (as monohydrate)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Plain aqueous solutions are sterile, isotonic and contain lidocaine
(lignocaine) hydrochloride
monohydrate, sodium chloride, sodium hydroxide for pH adjustment and
water for injections.
LIDOCAINE NORIDEM 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 20 mL solution for injection contains 200 mg lidocaine
hydrochloride
LIDOCAINE NORIDEM 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 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 NORIDEM is a clear, colourless solution for injection.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
LIDOCAINE NORIDEM 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 NORIDEM IS AVAILABLE IN 1% AND 2%. FOR PATIENTS REQUIRING
TREATMENT WITH
LIDOCAINE HYDROCHLORIDE 0.5%, OTHER BRANDS ARE AVAILABLE.
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 NORIDEM solutions contain no antimicrobial agent and should
be used only once
and any residue discarded.
Lidocaine (lignocaine) should be administered with grea