Cisatracurium besilate 20mg/10ml solution for injection vials

Pajjiż: Ingilterra

Lingwa: Ingliż

Sors: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredjent attiv:

Cisatracurium besilate

Disponibbli minn:

Accord-UK Ltd

Kodiċi ATC:

M03AC11

INN (Isem Internazzjonali):

Cisatracurium besilate

Dożaġġ:

2mg/1ml

Għamla farmaċewtika:

Solution for injection

Rotta amministrattiva:

Intravenous

Klassi:

No Controlled Drug Status

Tip ta 'preskrizzjoni:

Valid as a prescribable product

Sommarju tal-prodott:

BNF: 15010500; GTIN: 5055565714898

Fuljett ta 'informazzjoni

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
CISATRACURIUM 2 MG/ML SOLUTION FOR INJECTION/ INFUSION
CISATRACURIUM 5 MG/ML SOLUTION FOR INJECTION/ INFUSION
Cisatracurium
The name of your medicine are “Cisatracurium 2 mg/ml Solution for
injection/ infusion” and
“Cisatracurium 5 mg/ml Solution for injection/ infusion” but in
the rest of the leaflet it will be
called “Cisatracurium Injection 2 mg/ml” and “Cisatracurium
Injection 5 mg/ml”.
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.

If you get any side effects, talk to your doctor, nurse or pharmacist.
This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Cisatracurium Injection is and what it is used for
2.
What you need to know before you are given Cisatracurium Injection
3.
How Cisatracurium Injection is given
4.
Possible side effects
5.
How to store Cisatracurium Injection
6.
Contents of the pack and other information
1.
WHAT CISATRACURIUM INJECTION IS AND WHAT IT IS USED FOR
Cisatracurium Injection contains a medicine called cisatracurium. This
belongs to a group of
medicines called muscle relaxants.
Cisatracurium is an intermediate-duration, non-depolarising
neuromuscular blocking agent
for intravenous administration.
Cisatracurium Injection 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 INJECTION
DO NOT USE CISATRACURIUM INJECTION IF:

you are allergic (hypersensitive) to cisatracurium, any other muscle
relaxant or any of the
other ingredients

Karatteristiċi tal-prodott

OBJECT 1
CISATRACURIUM 2 MG/ML SOLUTION FOR
INJECTION/INFUSION
Summary of Product Characteristics Updated 04-Oct-2017 | Accord
Healthcare Limited
1. Name of the medicinal product
Cisatracurium 2 mg/ml Solution for injection/infusion
2. Qualitative and quantitative composition
Cisatracurium 2 mg as cisatracurium besilate 2.68 mg per 1 ml
• One vial of 2.5 ml contains 5 mg of cisatracurium
• One vial of 5 ml contains 10 mg of cisatracurium
• One vial of 10 ml contains 20 mg of cisatracurium
• One vial of 25 ml contains 50 mg of cisatracurium
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for injection/infusion.
A clear colourless to slightly yellow or greenish yellow solution.
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. Cisatracurium 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).
This medicinal product 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
re