Lidocaine Hydrochloride Injection BP Minijet 2% w/v Solution for Injection

País: Irlanda

Idioma: inglés

Fuente: HPRA (Health Products Regulatory Authority)

Ingredientes activos:

LIDOCAINE HYDROCHLORIDE

Disponible desde:

International Medication Systems (UK) Ltd

Código ATC:

C01BB; C01BB01; N01BB; N01BB02

Designación común internacional (DCI):

LIDOCAINE HYDROCHLORIDE

Dosis:

2 percent weight/volume

formulario farmacéutico:

Solution for injection

tipo de receta:

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

Área terapéutica:

Antiarrhythmics, class Ib; lidocaine; Amides; lidocaine

Estado de Autorización:

Not marketed

Fecha de autorización:

1977-09-08

Información para el usuario

Lidocaine Hydrochloride Injection BP
Minijet
®
, 1% and 2% w/v. Solution for
Injection. Lidocaine Hydrochloride.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE
YOU ARE GIVEN THIS MEDICINE.
• Keep this leaflet. You may need to
read it again
• If you have any further questions, ask
your doctor or nurse
• This medicine has been prescribed for
you. Do not pass it on to others. It
may harm them, even if their
symptoms are t
he same as yours
• In this leaflet, Lidocaine
Hydrochloride Injection BP Minijet
will be called Lidocaine Injection.
IN THIS LEAFLET:
1.What Lidocaine Injection is for
2.Before you are given Lidocaine
Injection
3.How Lidocaine Injection will be given
to you
4.Possible side effects
5.How to store Lidocaine Injection
6.Further information
1. WHAT LIDOCAINE INJECTION IS FOR
Lidocaine Injection belongs to a group
of medicines called local anaesthetics.
Local anaesthetics work by numbing the
area of the body that they are injected
into which stops pain being felt.
Lidocaine Injection is used to stop pain
being felt during medical investigations,
operations or in labour.
Lidocaine Injection can also be used to
treat heartbeat disturbances, espe
cially
after heart attacks or in heart surgery.
2. BEFORE YOU ARE GIVEN LIDOCAINE
INJECTION
YOU SHOULD NOT BE GIVEN LIDOCAINE
INJECTION IF:
• You are allergic to lidocaine or other
local anaesthetics
• You are allergic to any of the other
ingredients of Lidocaine Injection
(listed in section 6)
• You have acute porphyria (a blood
disorder in which excessive blood
pigment, porphyrin is excreted in the
urine and you are extremely sensitive
to light).
• You suffer from a slow or irregular
heartbea
t or heart block
• You suffer from Stokes-Adams
syndrome or attacks of temporary
loss of consciousness
If any of the above applies to you, you
should not be given Lidocaine Injection,
talk to your doctor or nurse.
CHECK WITH YOUR DOCTOR OR DENTIST BEFORE
YOU ARE GIVEN LIDOCAINE INJECTION IF:
• You have epilepsy
• You have liver disease
• You have any hea

Ficha técnica

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lidocaine Hydrochloride Injection BP Minijet 2% w/v Solution for
Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 20mg of Lidocaine Hydrochloride.
Each vial of 5ml contains 100mg of Lidocaine Hydrochloride.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
The clear, colourless, solution is contained in a USP Type I glass
vial with an elastomeric closure and has a pH of
between 5.0 and 7.0. The container is specially designed for use with
the IMS Minijet injector supplied.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For local anaesthesia by infiltration, intravenous regional
anaesthesia and nerve
blocks.
By intravenous injection for the emergency management of ventricular
arrhythmias, particularly after myocardial
infarction and cardiac surgery.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_For local anaesthesia:_
The dosage varies depending upon the area to be anaesthetised,
vascularity of the tissues, number of neuronal segments
to be blocked, individual tolerance and the anaesthetic technique. The
lowest dosage needed to provide anaesthesia
should be administered.
Adults: a maximum dose of 3 mg/kg or 200 mg, whichever is lower,
should not be exceeded.
Children: the usual dose should not exceed 3 mg/kg.
Elderly or debilitated patients require smaller doses, commensurate
with age and physical status.
For epidurals, a test dose should be administered at least 5 minutes
before total dose to prevent inadvertent
intravascular or subarachnoid injection.
For continuous epidural, caudal or paracervical anaesthesia, the
maximal dose should not be repeated at intervals under
90 minutes.
For i.v. regional anaesthesia (Bier’s block), the tourniquet should
not be released until at least 20 minutes after
administration.
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