Lidocaine hydrochloride 20 mg/ml, solution for injection/infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Lidocaine Hydrochloride Monohydrate

Available from:

Laboratoire AGUETTANT

ATC code:

N01BB02

INN (International Name):

Lidocaine Hydrochloride Monohydrate

Dosage:

20 milligram(s)/millilitre

Pharmaceutical form:

Solution for injection/infusion

Therapeutic area:

lidocaine

Authorization status:

Not marketed

Authorization date:

2020-11-13

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LIDOKAIN AGUETTANT 20 MG/ML, SOLUTION FOR INJECTION/INFUSION
lidocaine hydrochloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN 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, pharmacist or
nurse.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What is and what it is used for
2.
What you need to know before you are given
3.
How is given
4.
Possible side effects
5.
How to store
6.
Contents of the pack and other information
1.
WHAT IS AND WHAT IT IS USED FOR

contains the active substance lidocaine hydrochloride which is a local
anaesthetic.
is used in adults to numb part of the body during
small surgical procedures.
It stops the nerves from being able to pass pain messages to the brain
and so stops you feeling pain.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN
YOU MUST NOT BE GIVEN :
-
if you are allergic to lidocaine hydrochloride, to local anaesthetics
of the amide type or any of the
other ingredients of this medicine (listed in section 6).
-
if you have very low blood pressure, or if you have lost too much
blood or other body fluids or
your heart is unable to pump enough blood for other reasons, you
should not get
injected into your spine.
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before you are given
:
-
if you are elderly or in a generally debilitated condition.
-
if you have heart disorders including disorders in the heart's
electrical conduction system, heart
block , slow heartbeat, and heart failure.
-
if you have lung or breathing disorder.
-
if you have any kidney or liver disease.
-
if you have ep

Summary of Product characteristics

Health Products Regulatory Authority
25 October 2023
CRN00DQWC
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lidocaine hydrochloride 20 mg/ml, solution for injection/infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution for injection/infusion contains 20 mg of lidocaine
hydrochloride (equivalent to 21.33 mg of lidocaine
hydrochloride monohydrate).
Each 50 ml vial of solution for injection/infusion contains 1000 mg of
lidocaine hydrochloride (equivalent to 1066.5 mg of
lidocaine hydrochloride monohydrate).
Excipients with known effect:
This medicinal product contains sodium.
Each ml of solution for injection contains 2.0 mg of sodium equivalent
to 0.09 mmol of sodium.
Each 50-ml vial contains 101 mg of sodium equivalent to 4.4 mmol of
sodium.
For full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection/infusion
Clear colourless solution
pH: 5.0 to 7.0
Osmolality: 270-320 mOsm/Kg
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Lidocaine hydrochloride is indicated in adult patients for use in
infiltration anaesthesia, intravenous regional anaesthesia, nerve
blocks and epidural anaesthesia.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Lidocaine hydrochloride should only be used by, or under the
supervision of, doctors with experience of regional anaesthesia
and resuscitative skills. Facilities for resuscitation should be
available when administering local anaesthetics.
Posology
The lowest possible dose producing the required effect should be
given.
The table may serve as a guide for adults having a body weight of
about 70 kilograms. The dose should be adjusted according
to age, weight and condition of the patient.
Route of administration or
procedure
Recommended doses of Lidocaine hydrochloride
Concentration (mg/ml)
Volume
(ml)
Total dose
(mg)
Infiltration anaesthesia:
Large procedures
20mg/ml
5-10 ml
100-200 mg
Intravenous regional anaesthesia:
Arm
20mg/ml
5-10 ml
100-200 mg
Leg
20mg/ml
10 ml
200 mg
Nerve blocks
20mg/ml
1-10 ml
20-200