Lidocaine Hydrochloride 1% w/v Solution for Injection

দেশ: মাল্টা

ভাষা: ইংরেজি

সূত্র: Malta Medicines Authority

সক্রিয় উপাদান:

LIDOCAINE HYDROCHLORIDE

থেকে পাওয়া:

Mercury Pharma International Limited 4045 Kingswood Road, City West Business Park, Co, Dublin, Ireland

এটিসি কোড:

N01BB02

INN (আন্তর্জাতিক নাম):

LIDOCAINE HYDROCHLORIDE 1 mg/ml

ফার্মাসিউটিকাল ফর্ম:

SOLUTION FOR INJECTION

রচনা:

LIDOCAINE HYDROCHLORIDE 1 mg/ml

প্রেসক্রিপশন টাইপ:

POM

থেরাপিউটিক এলাকা:

ANESTHETICS

অনুমোদন অবস্থা:

Withdrawn

অনুমোদন তারিখ:

2006-12-18

তথ্য লিফলেট

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LIDOCAINE HYDROCHLORIDE 0.5% W/V SOLUTION FOR INJECTION
LIDOCAINE HYDROCHLORIDE 1% W/V SOLUTION FOR INJECTION
LIDOCAINE HYDROCHLORIDE 2% W/V SOLUTION FOR INJECTION
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, pharmacist 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 the same as yours.
- If you get any side effects, talk to your doctor, pharmacist or
nurse. This includes any possible
side effects not listed in this leafleat. See section 4.
The product is referred as above but for ease it has been mentioned as
Lidocaine hydrochloride
throughout the leaflet.
WHAT IS IN THIS LEAFLET
1. What Lidocaine Hydrochloride is and what it is used for
2. What you need to know before you are given Lidocaine Hydrochloride
3. How Lidocaine Hydrochloride is given to you
4. Possible side effects
5. How to store Lidocaine Hydrochloride
6. Contents of the pack and other information. WHAT LIDOCAINE
HYDROCHLORIDE IS AND
WHAT IT IS USED FOR
1. WHAT LIDOCAINE HYDROCHLORIDE IS AND WHAT IT IS USED FOR
Lidocaine Hydrochloride is a local anaesthetic and belongs to a class
of drugs called amide type
local anaesthetics. It produces loss of feeling or sensation confined
to one part of the body.
Lidocaine Hydrochloride Injection may be used to produce local
numbness (anaesthesia)
by injection of the solution into or around the area of operation. It
may also be used to
produce local anaesthesia by injection of the solution close to the
nerves whose conduction
is to be cut off, or into the epidural space near the spinal cord, or
by administering the solution
into a vein in a limb that has been isolated from the circulation by
means of a tourniquet
(bandage that stops the flow of blood from vessel by applying
pressure).2. BEFORE YOU ARE
GIVEN L

পণ্য বৈশিষ্ট্য

Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Lidocaine Hydrochloride 1% w/v Solution for Injection
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1ml of solution contains 1.0% w/v of Lidocaine Hydrochloride B.P.
Excipient(s) with known effect
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Solution for Injection
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Lidocaine is a local anaesthetic of the amide group. The injectable
form has a wide range of
applications for nerve blockade. It can be used by percutaneous
infiltration; to block a major
nerve plexus such as the brachial; for epidural anaesthesia; for
intravenous regional analgesia.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
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. The maximum dose for healthy adults should not exceed 200mg.
Children and elderly or debilitated patients require smaller doses,
commensurate with age and
physical status.
Page 2 of 12
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance, to anaesthetics of the amide
type or to any of the
excipients listed in section 6.1.
Lidocaine is contraindicated in patients with:
-
Complete heart block
-
Hypovolaemia
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Lidocaine should be administered by persons with resuscitative skills
and equipment.
Facilities for resuscitation should be available when administering
local anaesthetics.
It should be used with caution in patients with myasthenia gravis,
epilepsy, congestive
heart failure, bradycardia or respiratory depression, including where
agents are known to
interact with Lidocaine either to increase its availability or
additive effects e.g. phenytoin
or prolong its elimination e.g. hepatic or end renal insufficiency
where the metabolites of
Lidocaine may accumulate.
Intramuscular Lidocaine may increase creatinine phosphokinase
concentration