LIDOCAINE HYDROCHLORIDE 2.0 %w/v Solution for Injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

LIDOCAINE HYDROCHLORIDE

Available from:

Mercury Pharmaceuticals (Ireland) Ltd

ATC code:

N01BB02

INN (International Name):

LIDOCAINE HYDROCHLORIDE

Dosage:

2.0 %w/v

Pharmaceutical form:

Solution for Injection

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Amides

Authorization status:

Authorised

Authorization date:

1994-04-19

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
LIDOCAINE HYDROCHLORIDE 2% W/V SOLUTION FOR INJECTION
LIDOCAINE HYDROCHLORIDE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
- KEEP THIS LEAFLET. YOU MAY NEED TO READ IT AGAIN.
- IF YOU HAVE ANY FURTHER QUESTIONS, ASK YOUR DOCTOR OR PHARMACIST.
- THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU ONLY. DO NOT PASS IT ON TO
OTHERS. IT MAY HARM THEM, EVEN
IF THEIR SIGNS OF ILLNESS ARE THE SAME AS YOURS.
- IF YOU GET ANY SIDE EFFECTS, TALK TO YOUR DOCTOR OR PHARMACIST. THIS
INCLUDES ANY POSSIBLE SIDE EFFECTS
NOT LISTED IN THIS LEAFLET. SEE SECTION 4.
WHAT IS IN THIS LEAFLET
1. WHAT LIDOCAINE INJECTION IS AND WHAT IT IS USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LIDOCAINE INJECTION
3. HOW TO TAKE LIDOCAINE INJECTION
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE LIDOCAINE INJECTION
6. CONTENTS OF THE PACK AND OTHER INFORMATION
1. WHAT LIDOCAINE INJECTION IS AND WHAT IT IS USED FOR
Lidocaine Hydrochloride is a local anaesthetic. It produces loss of
feeling or sensation confined to one part
of the body (local anaesthesia). Lidocaine belongs to a group of
medicines called amide-type local
anaesthetics.
Lidocaine Injection may be used to produce local anaesthesia by
injection of the solution into or around a
peripheral nerve or network of nerves, in children and adults. It may
also be used in adults to relieve pain by
administering the solution into the epidural space, which is close to
the spinal cord, or into a vein in a limb
that has been isolated from the circulation by means of a tourniquet.
The dosage should be adjusted
according to the response of the patient and the site of
administration and with precautions in children and
elderly.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LIDOCAINE INJECTION
DO NOT USE LIDOCAINE INJECTION IF YOU:
• Are allergic to lidocaine or to any other amide-type of local
anaesthetic or any of the other ingredients
of this medicine (listed in section 6).
WARNINGS AND PRECAUTIONS
T

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lidocaine Hydrochloride 2% w/v Solution for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1ml of solution contains 20mg of Lidocaine Hydrochloride
(Lignocaine Hydrochloride).
Each 2 ml ampoule contains 40mg of Lidocaine Hydrochloride.
Each 5 ml ampoule contains 100mg of Lidocaine Hydrochloride.
Each 20 ml ampoule contains 400mg (0.4g) of Lidocaine Hydrochloride
For full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
Clear colourless sterile solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
As a local anaesthetic agent.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Route of administration:
Adults: Infiltration by injection. Intravenous, Epidural.
Children: Infiltration by injection
The dosage should be adjusted according to the response of the patient
and the site of administration. The lowest
concentration and smallest dose producing the required effect should
be given in healthy adults. A maximum dose of
3mg/kg or 200mg, whichever is the lower, should not be exceeded.
Elderly or debilitated patients require smaller doses, commensurate
with age and physical status.
Paediatric population:
For Infiltration anaesthesia only
According to nature of procedure, up to 3 mg/kg (0.3 mL/kg of 1%
solution) to a maximum of 200mg, repeated not
more often than every 4 hours.
4.3 CONTRAINDICATIONS
Known hypersensitivity to lidocaine or to other local anaesthetics of
the amide type.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Great caution must be exercised to avoid accidental intravascular
injection of this agent, since it may give rise to the
rapid onset of toxicity, with marked restlessness, twitching, or
convulsions, followed by coma with apnoea and
cardiovascular collapse. Facilities for resuscitation should be
available when administering local anaesthetics.
H
E
A
L
T
H
P
R
O
D
U
C
T
S
R
E
G
U
L
A
T
O
R
Y
A
U
T
H
O
R
I
T
Y
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
_