Bupivacaine Baxter 5 mg/ml Injektionsvätska, lösning

Pays: Suède

Langue: suédois

Source: Läkemedelsverket (Medical Products Agency)

Ingrédients actifs:

bupivakainhydroklorid, vattenfri

Disponible depuis:

Baxter Holding B.V.

Code ATC:

N01BB01

DCI (Dénomination commune internationale):

bupivacaine hydrochloride, anhydrous

Dosage:

5 mg/ml

forme pharmaceutique:

Injektionsvätska, lösning

Composition:

bupivakainhydroklorid, vattenfri 5 mg Aktiv substans

Type d'ordonnance:

Receptbelagt

Descriptif du produit:

Förpacknings: Injektionsflaska, 5 x 10 ml; Injektionsflaska, 10 x 10 ml; Injektionsflaska, 10 x 20 ml; Injektionsflaska, 5 x 20 ml; Injektionsflaska, 1 x 20 ml

Statut de autorisation:

Godkänd

Date de l'autorisation:

2015-10-09

Notice patient

PACKAGE LEAFLET: INFORMATION FOR THE USER
BUPIVACAINE BAXTER 2.5 MG/ML SOLUTION FOR INJECTION
BUPIVACAINE BAXTER 5 MG/ML SOLUTION FOR INJECTION
Bupivacaine 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.
-
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 Bupivacaine Baxter is and what it is used for
2.
What you need to know before you use Bupivacaine Baxter
3.
How to use Bupivacaine Baxter
4.
Possible side effects
5.
How to store Bupivacaine Baxter
6.
Contents of the pack and other information
1.
WHAT BUPIVACAINE BAXTER IS AND WHAT IT IS USED FOR
Bupivacaine Baxter is a local anaesthetic. It belongs to a group of
medicines called amide-type local
anaesthetics. It works by blocking the transmission of pain signals
through nerves in or near the spinal
cord. It is used to numb or make parts of the body free from pain.
Bupivacaine Baxter can be used to:
•
numb parts of the body during surgery in adults and adolescents above
12 years
•
relieve of acute pain in adults, infants and children above 1 year of
age
It is used for example in surgical operations and as relief of pain
after an operation.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE BUPIVACAINE BAXTER
YOU SHOULD NOT BE GIVEN BUPIVACAINE BAXTER:
•
if you are allergic to bupivacaine hydrochloride or local anaesthetics
of the amide type or to
any of the other ingredients of this medicine (listed in section 6).
•
to numb an area by injecting Bupivacine Baxter into a vein
•
to produce epidural anaesthesia in case you have:
-
very low blood pressure or low blood volume
-
a disease in the central nervous system, e.g. meningitis, polio,
tumours, increased
pressure or bleedings into your brain
-
a disease in the backbon

Résumé des caractéristiques du produit

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Bupivacaine Baxter 2.5 mg/ml solution for injection
Bupivacaine Baxter 5 mg/ml solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 2.5 mg or 5 mg of bupivacaine hydrochloride.
Excipients with known effect:
Each ml of the solution contains 3.15 mg of sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless aqueous solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
•
Surgical anaesthesia in adults and adolescents above 12 years of age
•
Acute pain management in adults, infants and children above 1 year of
age
Infiltration anesthesia when prolonged duration of action is required,
e.g. for post-operative pain.
Conduction anesthesia with prolonged duration or epidural anesthesia
in cases where addition of epinephrine
is contraindicated and severe muscle relaxation is not desirable.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Bupivacaine Baxter should only be used by physicians experienced in
regional anaesthesia or under his or
hers supervision. The lowest dosage needed to provide effective
anaesthesia should be administered.
In order to avoid intravascular injection, aspiration should be
repeated prior to and during administration of
the main dose, which should be injected slowly or in divided doses, at
a rate of 25-50 mg/min, while closely
observing the patient's vital functions and maintaining verbal
contact.
When an epidural dose is to be injected, a preceding test dose of 3-5
ml bupivacaine containing adrenaline
(epinephrine) is recommended. An inadvertent intravascular injection
may be recognised by a temporary
increase in heart rate and an accidental intrathecal injection by
signs of a spinal block. If toxic symptoms
occur, the injection should be stopped immediately.
The dosage varies and depends upon the area to be anaesthetised, the
vascularity of the tissues, the number
of neuronal segments to be blocked, individual tole