Lidocaine 10 mg/ ml (1% w/v) solution for injection in pre-filled syringe

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Lidocaine hydrochloride

Available from:

Laboratoire AGUETTANT

ATC code:

N01BB; N01BB02

INN (International Name):

Lidocaine hydrochloride

Dosage:

10 milligram(s)/millilitre

Pharmaceutical form:

Solution for injection in pre-filled syringe

Prescription type:

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

Therapeutic area:

Amides; lidocaine

Authorization status:

Marketed

Authorization date:

2018-07-20

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LIDOCAINE 10 MG/ML (1 % W/V) SOLUTION FOR INJECTION IN PRE-FILLED
SYRINGE
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 Lidocaine is and what it is used for
2.
What you need to know before you are given Lidocaine
3.
How Lidocaine is given
4.
Possible side effects
5.
How to store Lidocaine
6.
Contents of the pack and other information
1.
WHAT LIDOCAINE IS AND WHAT IT IS USED FOR
Lidocaine contains the active substance lidocaine hydrochloride.
Lidocaine is a local anaesthetic. It is used to numb parts of the body
during 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 LIDOCAINE
YOU MUST NOT BE GIVEN LIDOCAINE :
-
if you are allergic to lidocaine, local anaesthetics of the amide type
or any of the other
ingredients of this medicine (listed in section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before you are given
Lidocaine :
-
if you suffer from epilepsy. Your doctor will monitor you closely for
manifestation of
symptoms.
-
if you have kidney or liver disease.
-
if you have a disease leading to muscle weakness (myasthenia gravis).
-
if you have heart disorders including conduction disorders, slow
heartbeat.
-
if you have respiratory depression (breathing difficulties with slow
and shallow breathing).
-
if you are elderly or have a poor general health condition.
-
if you have, or are treated for, bleeding disorders.
Additionally your doctor knows that an injection of this medicine into
inflamed tissue may lead to an
incr

Summary of Product characteristics

Health Products Regulatory Authority
25 October 2023
CRN00DQWC
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lidocaine 10 mg/ ml (1% w/v) solution for injection in pre-filled
syringe
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution for injection contains 10 mg of lidocaine
hydrochloride (as lidocaine hydrochloride monohydrate).
Each 10 ml pre-filled syringe contains 100 mg of lidocaine
hydrochloride (as lidocaine hydrochloride monohydrate).
Excipient with known effect:
Each ml of solution for injection contains 3.2 mg equivalent to 0.14
mmol of sodium.
Each 10 ml pre-filled syringe contains 32 mg equivalent to 1.4 mmol of
sodium.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection (injection).
Clear and colorless solution
pH: 5.0 to 6.5
Osmolality: 270-330 mOsm/Kg
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Lidocaine is indicated in infiltration anaesthesia and peripheral
nerve block anaesthesia.
Lidocaine 10 mg/ml (1 % w/v) is indicated for adults and children
above 2 years.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Lidocaine 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 concentration and smallest dose producing the required
effect should be given.
_Adults_
The dose should be adjusted according to the response of the patient,
the site of administration, and the expected duration of
the surgical procedure.
It should be considered that usual total dose of lidocaine is 3–5
mg/kg; corresponding to volumes of 2 to 20 mL (at 10 mg/ml)
and 1 to 10 mL (at 20 mg/ml).
The generally maximum recommended total dose of lidocaine should not
exceed 200 mg in adults for infiltration and
peripheral nerve block, but depending on the procedure and patient
factors, higher maximum doses may be required.
The volume of the solution used plays a role in