Atracurium Kalceks 10 mg/ml solution for injection/infusion - 5ml

Country: Մալթա

language: անգլերեն

source: Medicines Authority

active_ingredient:

ATRACURIUM BESILATE

MAH:

AS KALCEKS Krustpils iela 71E, Riga, LV-1057,, Latvia

ATC_code:

M03AC04

INN:

ATRACURIUM BESILATE 10 mg/ml

pharmaceutical_form:

SOLUTION FOR INFUSION OR INJECTION

composition:

ATRACURIUM BESILATE 10 mg/ml

prescription_type:

POM

therapeutic_area:

MUSCLE RELAXANTS

leaflet_short:

Licence number in the source country: NOT APPLICAPABLE

authorization_status:

Authorised

authorization_date:

2022-02-02

PIL

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ATRACURIUM KALCEKS 10 MG/ML SOLUTION FOR INJECTION/INFUSION
atracurium besilate
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 or nurse.
-
If you get any side effects, talk to your doctor or nurse. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Atracurium Kalceks is and what it is used for
2.
What you need to know before you receive Atracurium Kalceks
3.
How to use Atracurium Kalceks
4.
Possible side effects
5.
How to store Atracurium Kalceks
6.
Contents of the pack and other information
1.
WHAT ATRACURIUM KALCEKS IS AND WHAT IT IS USED FOR
Atracurium Kalceks belongs to a group of medicines called muscle
relaxants.
Atracurium Kalceks is used during surgery to relax muscles and to
assist with inserting a breathing
tube and with artificial breathing. It is also used to help with
artificial breathing at patients in intensive
care units.
2.
WHAT YOU NEED TO KNOW BEFORE YOU RECEIVE ATRACURIUM KALCEKS
ATRACURIUM KALCEKS CANNOT BE ADMINISTERED:
-
if you are
allergic to atracurium besilate, cisatracurium or any of the other
ingredients of this
medicine (listed in section 6).
If you think that this applies to you talk to your doctor before
Atracurium Kalceks is administered to
you.
WARNINGS AND PRECAUTIONS
Talk to your doctor or nurse before using Atracurium Kalceks:
-
if you have an allergy or bronchial asthma;
-
if you have ever had an allergic reaction to other medicines similar
to Atracurium Kalceks that
blocks the transmission of impulses between a nerve and muscle;
-
if you suffer from muscle weakness, tiredness or difficulty in
coordination of movements
(
_myasthenia gravis_
);
-
if you suffer from a neuromuscular disease;
-
if you have a heart disease or you are sensitive to a drop in blood
pressure;
-
if you have severe elec

SPC

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Atracurium Kalceks 10 mg/ml solution for injection/infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of solution contains 10 mg of atracurium besilate.
Each ampoule (2.5 ml) contains 25 mg of atracurium besilate.
Each ampoule (5 ml) contains 50 mg of atracurium besilate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection/infusion.
Clear colourless or yellowish solution, free from visible particles.
pH of solution is 3.30 to 3.65 and osmolality is 10 – 30 mOsmol/kg.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
This medicine is used as an adjunct to general anaesthesia to
facilitate tracheal intubation, to relax
skeletal muscles during surgery or controlled ventilation, and to
facilitate mechanical ventilation of
patients in the intensive care unit.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults _
_ _
_Dosage by intravenous injection _
Atracurium besilate is administered by intravenous injection. The
usual dose for adults ranges from
0.3 to 0.6 mg/kg of body weight (depending on the required duration of
full block) and provides
adequate relaxation for 15 to 35 minutes.
Endotracheal intubation can usually be accomplished within 90 seconds
from the intravenous injection
of 0.5 to 0.6 mg/kg.
Full block can be prolonged with supplementary doses of 0.1 to 0.2
mg/kg as required. Successive
supplementary dosing does not give rise to accumulation of
neuromuscular blocking effect.
Caesarean Section:
Atracurium besilate is suitable for maintenance of muscle relaxation
during Caesarean section as it
does not cross the placenta in clinically significant amounts
following recommended doses
(0.3-0.6 mg/kg).
Spontaneous recovery of normal muscle tone occurs after approximately
35 minutes when
neuromuscular function restored to 95 % of its baseline (measured by
the restoration of the tetanic
response).
The neuromuscular block produced by atracurium besilate can be rapidly
reversed by standar