Lidokain Ebb 20 mg/ml Injektionsvätska, lösning

Země: Švédsko

Jazyk: švédština

Zdroj: Läkemedelsverket (Medical Products Agency)

Aktivní složka:

lidokainhydrokloridmonohydrat

Dostupné s:

Ebb Medical AB

ATC kód:

N01BB02

INN (Mezinárodní Name):

lidokainhydrokloridmonohydrat

Dávkování:

20 mg/ml

Léková forma:

Injektionsvätska, lösning

Složení:

lidokainhydrokloridmonohydrat 21,33 mg Aktiv substans

Druh předpisu:

Receptbelagt

Přehled produktů:

Förpacknings: Ampull, 10 x 5 ml

Stav Autorizace:

Avregistrerad

Datum autorizace:

2017-02-15

Informace pro uživatele

PACKAGE LEAFLET: INFORMATION FOR THE USER
LIDOCAINE GRINDEKS 20 MG/ML SOLUTION FOR INJECTION
lidocaine hydrochloride
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 only. Do not pass it on to
others. It may harm them,
even if their signs of illness 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 leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Lidocaine Grindeks is and what it is used for
2.
What you need to know before you are given Lidocaine Grindeks
3.
How Lidocaine Grindeks is given
4.
Possible side effects
5.
How to store Lidocaine Grindeks
6.
Contents of the pack and other information
1.
WHAT LIDOCAINE GRINDEKS IS AND WHAT IT IS USED FOR
Lidocaine Grindeks is a local anaesthetic. It is used to numb parts of
the body during small surgical
procedures in adults. It stops the nerves from being able to pass pain
messages to the brain and so stops
you feeling pain. It starts to work a few minutes after being injected
and slowly wears off when the
surgical procedure is over.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN LIDOCAINE GRINDEKS
DO NOT USE LIDOCAINE GRINDEKS
-
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
Lidocaine Grindeks injected into your spine.
WARNINGS AND PRECAUTIONS
Talk to your doctor or nurse before having Lidocaine Grindeks
injection if:

you are elderly or in a generally debilitated condition,

you have heart problems such as a slow or irregular h

Charakteristika produktu

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Lidocaine Grindeks 20 mg/ml solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of solution contains 20 mg lidocaine hydrochloride.
Each 5 ml ampoule contains 100 mg lidocaine hydrochloride.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection
A clear, colourless or slightly yellowish liquid, free from visible
particles.
pH of solution 5.0-7.0
Osmolality of solution 0.310-0.340 Osmol/kg
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Intravenous regional anaesthesia, infiltration anaesthesia, nerve
blocks and epidural anaesthesia.
Lidocaine Grindeks is indicated in adults.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Lidocaine Grindeks should only be used by, or under the supervision
of, doctors with experience of
regional anaesthesia. The lowest possible dose producing the required
effect should be given.
Aspiration to control for accidental intravenous injection is
recommended before injection of the full
dose. Inject slow and keep contact with the patient during injection.
For epidural injection, a small test
dose of 3-5 ml is recommended.
Injection of a cold solution below the body temperature should be
avoided, as this could be painful.
_Intravenous regional anaesthesia_
Arm: 5-10 ml of solution (100-200 mg of lidocaine hydrochloride).
Leg: 10 ml of solution (200 mg of lidocaine hydrochloride).
_Nerve blocks_
1-2 ml of solution (20-40 mg of lidocaine hydrochloride).
_Epidural anaesthesia_
Lumbar analgesia: 12.5-20 ml of solution (250-400 mg of lidocaine
hydrochloride).
Thoracic anaesthesia: 10-15 ml of solution (200-300 mg of lidocaine
hydrochloride).
Sacral surgery analgesia: 20 ml of solution (400 mg of lidocaine
hydrochloride).
Sacral obstetric analgesia:10-15 ml of solution (200-300 mg of
lidocaine hydrochloride).
The recommended maximum single dose of lidocaine hydrochloride should
not exceed 400 mg.
The dose should be reduced for patients in poor general condition