Cisatracurium 2 mg/ml solution for injection/infusion

Land: Irland

Sprache: Englisch

Quelle: HPRA (Health Products Regulatory Authority)

Wirkstoff:

Cisatracurium Besilate; Cisatracurium

Verfügbar ab:

AS Kalceks

ATC-Code:

M03AC11

INN (Internationale Bezeichnung):

Cisatracurium Besilate; Cisatracurium

Dosierung:

2 milligram(s)/millilitre

Darreichungsform:

Solution for injection/infusion

Therapiebereich:

cisatracurium

Berechtigungsstatus:

Marketed

Berechtigungsdatum:

2019-09-13

Gebrauchsinformation

PACKAGE LEAFLET: INFORMATION FOR THE USER
CISATRACURIUM 2 MG/ML SOLUTION FOR INJECTION/INFUSION
Cisatracurium
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN 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 Cisatracurium is and what it is used for
2.
What you need to know before you are given Cisatracurium
3.
How Cisatracurium is given
4.
Possible side effects
5.
How to store Cisatracurium
6.
Contents of the pack and other information
1.
WHAT CISATRACURIUM IS AND WHAT IT IS USED FOR
Cisatracurium contains a medicine called cisatracurium. This belongs
to a group of medicines called
muscle relaxants.
Cisatracurium is used:
‒
to relax muscles during operations on adults and children over 1 month
of age, including heart surgery;
‒
to help insert a tube into the windpipe (tracheal intubation), if a
person needs help to breathe;
‒
to relax the muscles of adults in intensive care.
Ask your doctor if you would like more explanation about this
medicine.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN CISATRACURIUM
YOU SHOULD NOT BE GIVEN CISATRACURIUM
‒
if you are allergic to cisatracurium, atracurium or benzenesulfonic
acid or any of the other ingredients
of this medicine (listed in section 6).
If any of the above apply to you tell your doctor or nurse before you
are given Cisatracurium.
WARNINGS AND PRECAUTIONS
Talk to your doctor or nurse before you are given Cisatracurium:
‒
if you have muscle weakness, tiredness or difficulty in coordinating
your movements (myasthenia
gravis);
‒
you have a neuromuscular disease, such as a muscle wasting disease,
paralysis, motor neurone disease
or cerebral palsy;
‒
if you have a burn which requires medical treatment;
‒
if you have severe acid-base and/or

Fachinformation

Health Products Regulatory Authority
13 June 2023
CRN00DHJN
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cisatracurium 2 mg/ml solution for injection/infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution contains 2 mg of cisatracurium (as cisatracurium
besilate).
Each 2.5 ml ampoule contains 5 mg of cisatracurium.
Each 5 ml ampoule contains 10 mg of cisatracurium.
Each 10 ml ampoule contains 20 mg of cisatracurium.
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 3.0‑3.8
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Cisatracurium is indicated for use during surgical and other
procedures in adults and children aged 1 month and over. It is also
indicated for use in adults requiring intensive care. Cisatracurium
can be used as an adjunct to general anaesthesia, or sedation
in the Intensive Care Unit (ICU) to relax skeletal muscles, and to
facilitate tracheal intubation and mechanical ventilation.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Cisatracurium should only be administered by or under the supervision
of anaesthetists or other clinicians who are familiar with
the use and action of neuromuscular blocking agents. Facilities for
tracheal intubation, and maintenance of pulmonary
ventilation and adequate arterial oxygenation have to be available.
Please note that Cisatracurium should not be mixed in the same syringe
or administered simultaneously through the same
needle as propofol injectable emulsion or with alkaline solutions such
as sodium thiopentone. (see section 6.2).
Cisatracurium contains no antimicrobial preservative and is intended
for single patient use.
Monitoring advice
As with other neuromuscular blocking agents, monitoring of
neuromuscular function is recommended during the use of
cisatracurium in order to individualise dosage requirements.
Posology
1.USE BY INTRAVENOUS BOLUS INJECTION
_DOSAGE IN ADULTS_