Lidocaine 200mg/20ml (1%) solution for injection vials

Land: Verenigd Koninkrijk

Taal: Engels

Bron: MHRA (Medicines & Healthcare Products Regulatory Agency)

Werkstoffen:

Lidocaine hydrochloride

Beschikbaar vanaf:

1%) solution for injection vials (hameln pharma Ltd

ATC-code:

N01BB02

INN (Algemene Internationale Benaming):

Lidocaine hydrochloride

Dosering:

10mg/1ml

farmaceutische vorm:

Solution for injection

Toedieningsweg:

Subcutaneous

klasse:

No Controlled Drug Status

Prescription-type:

Valid as a prescribable product

Product samenvatting:

BNF: 15020100; GTIN: 5016386003356

Bijsluiter

PATIENT INFORMATION LEAFLET
LIDOCAINE INJECTION WITH PRESERVATIVE 1%
LIDOCAINE HYDROCHLORIDE
1. What Lidocaine Injection with Preservative
1% is and what it is used for
Lidocaine Injection with Preservative 1% is a
local anaesthetic and is used to produce local
anaesthesia (numb a specific area) and
STOP
PAIN BEING FELT
in the area of the body where
it is administered.
2. What you need to know before you use
Lidocaine Injection with Preservative 1%
DO
NOT
USE
LIDOCAINE
INJECTION
WITH
PRESERVATIVE 1%:
•
if
you
are
SENSITIVE
OR
ALLERGIC
to
Lidocaine
Hydrochloride
or
any
of
the
PRESERVATIVES
(methylhydroxybenzoate and
propylhydroxybenzoate) or other ingredients in
this injection. The preservatives are often known
just as benzoates or hydroxyl-benzoates. (see
also section 4. “Possible side effects” for further
information).
Tell your doctor if you ever had an
ALLERGIC
or
BAD REACTION
, for example, skin rash or
breathlessness, to
ANY LOCAL ANAESTHETIC
medicines or to
ANY PRESERVATIVES
.
•
if
you
have
certain
HEART
disorders.
Tell
your doctor if you have any heart problems
particularly where your heart may pump blood
less efficiently, may beat irregularly, or may
beat more slowly.
WARNINGS AND PRECAUTIONS
TALK TO YOUR DOCTOR, PHARMACIST OR NURSE
BEFORE
USING
LIDOCAINE
INJECTION
WITH
PRESERVATIVE 1%:
•
if you suffer from
PORPHYRIA
- a disorder of the
blood. Tell your doctor if you have any blood
disorders.
•
if you suffer from a
HEART
or a
BREATHING
disorder.
•
if you have
KIDNEY
or
LIVER
disease.
•
if you are feeling
UNWELL
or
RUN DOWN
for any
reason.
•
if you suffer from
EPILEPSY
or have
FITS
.
•
if you have
MYASTHENIA GRAVIS
(a condition
causing weakness of your muscles).
•
if you are in
SHOCK
.
•
if
you
have
a
BLOOD
DISORDER
or
an
IMBALANCE
in
the
CONSTITUENTS
of
your
BLOOD
.
Important information about your medicine
►
Your doctor or nurse will give you the injection
►
If this injection causes you any problems talk to your doctor, nurse
or pharmacist
►
Please tell your doctor or pharma

Productkenmerken

OBJECT 1
LIDOCAINE INJECTION BP WITH PRESERVATIVE 1%
Summary of Product Characteristics Updated 05-Jun-2015 | hameln
pharmaceuticals ltd
1. Name of the medicinal product
Lidocaine Injection BP with Preservative 1 %
2. Qualitative and quantitative composition
Each 1 ml contains 10.0 mg of lidocaine hydrochloride, corresponding
to 8.1 mg lidocaine.
Each 20 ml solution contains 200 mg Lidocaine Hydrochloride
For the full list of excipients, see section 6.1
3. Pharmaceutical form
Solution for injection.
Clear and colourless solution.
4. Clinical particulars
4.1 Therapeutic indications
Lidocaine Injection is used as a local anaesthetic.
4.2 Posology and method of administration
Lidocaine Injection is used as a local anaesthetic when injected
subcutaneously.
This solution is not intended for use intravenously. Solutions of
lidocaine which contain preservatives
should not be used for spinal, epidural, caudal or intravenous
regional anaesthesia.
The dosage should be adjusted according to the response of the patient
and the site of administration. The
lowest concentration and the smallest dose producing the required
effect should be given. The maximum
single dose for healthy adults should not exceed 200 mg corresponding
to 20 mls.
Children and elderly or debilitated patients require smaller doses,
commensurate with age and physical
status.
4.3 Contraindications
• Known hypersensitivity to lidocaine or other anaesthetics of the
amide type
• Known hypersensitivity to hydroxybenzoates
• Complete heart block
• Hypovolaemia
4.4 Special warnings and precautions for use
As with other local anaesthetics, lidocaine should be used with
caution in patients with epilepsy, cardiac
conduction disturbances, (see also section 4.3 Contraindications)
congestive cardiac failure, bradycardia,
severe shock, impaired respiratory function or impaired renal function
with a creatinine clearance of less
than 10mL/minute. Lidocaine is metabolised in the liver and it should
be used with caution in patients
with impaired hepatic function. Lid