Cisatracurium 2 mg/ml solution for injection/infusion

Krajina: Írsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktívna zložka:

Cisatracurium

Dostupné z:

Noridem Enterprises Limited

ATC kód:

M03AC; M03AC11

INN (Medzinárodný Name):

Cisatracurium

Dávkovanie:

2 milligram(s)/millilitre

Forma lieku:

Solution for injection/infusion

Typ predpisu:

Product subject to prescription which may not be renewed (A)

Terapeutické oblasti:

Other quaternary ammonium compounds; cisatracurium

Stav Autorizácia:

Not marketed

Dátum Autorizácia:

2013-07-12

Príbalový leták

PACKAGE LEAFLET
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.

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 leaflet. See section 4.
THE NAME OF YOUR MEDICINE IS CISATRACURIUM 2 MG/ML SOLUTION FOR
INJECTION/INFUSION _In the rest of this leaflet Cisatracurium 2 mg/ml Solution for
Injection/Infusion is called _
_Cisatracurium._
WHAT IS IN THIS LEAFLET
:
1. What Cisatracurium is and what it is used for
2. What you need to know before you use Cisatracurium
3. How to use Cisatracurium
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
The active substance is cisatracurium besilate, which 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 USE CISATRACURIUM
DO NOT USE CISATRACURIUM IF YOU:
• are allergic (hypersensitive) to the active substance, any other
muscle relaxant or any of the
other ingredients in this medicine (listed in section 6).
• have reacted badly to an anaesthetic before.
Do not receive Cisatracurium if any of the above apply to you. If you
are not sure, talk to your
doctor, nurse or pharmacist before you receive Cisatracurium

Súhrn charakteristických

Health Products Regulatory Authority
12 August 2021
CRN00CGPT
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cisatracurium 2 mg/ml solution for injection/infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One ampoule of 2.5ml contains 5mg of cisatracurium
One ampoule of 5ml contains 10mg of cisatracurium
One ampoule of 10ml contains 20mg of cisatracurium
One ml contains cisatracurium besilate corresponding to 2 mg
Cisatracurium.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection/infusion.
Colourless to pale yellow or greenish yellow solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Cisatracurium is an intermediate-duration, non-depolarising
neuromuscular blocking agent for intravenous administration.
Cisatracurium is indicated for use during surgical and other
procedures and in intensive care in adults and children aged 1
month and over. 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.
USE BY INTRAVENOUS BOLUS INJECTIO