Cisatracurium besilate 5mg/2.5ml solution for injection vials
Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Patient Information leaflet
(PIL)
20-06-2018
Summary of Product characteristics
(SPC)
20-06-2018
Active ingredient:
Cisatracurium besilate
Available from:
Hospira UK Ltd
ATC code:
M03AC11
INN (International Name):
Cisatracurium besilate
Dosage:
2mg/1ml
Pharmaceutical form:
Solution for injection
Administration route:
Intravenous
Class:
No Controlled Drug Status
Prescription type:
Valid as a prescribable product
Product summary:
BNF: 15010500
Patient Information leaflet
Page 1 of 5
PACKAGE LEAFLET: INFORMATION FOR THE USER
CISATRACURIUM 2 MG/ML SOLUTION FOR INJECTION/INFUSION
CISATRACURIUM 5 MG/ML SOLUTION FOR INJECTION/INFUSION
Cisatracurium
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
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 any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor or pharmacist. See section 4.
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
This medicine belongs to a group of medicines called muscle relaxants.
The full name of this
medicine is Cisatracurium solution for injection/infusion but for ease
of reference it will be
referred to as Cisatracurium throughout the leaflet.
Cisatracurium is used
- During surgery and other procedures and in intensive care
- With general anaesthesia, or sedation in the Intensive Care Unit to
relax muscles
- To help insert a tube into the windpipe (tracheal intubation) if a
person needs help to breathe
(with or without a machine).
Cisatracurium is used in adults and in children over 1 month of age.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE CISATRACURIUM
DO NOT USE CISATRACURIUM
-
If you are allergic (hypersensitive) to cisatracurium besilate,
atracurium, or any of the
ingredients in this medicine (listed in section 6)
WARNINGS AND PRECAUTIONS
Talk to your doctor before using this medicine if you:
-
have a neuromuscular disease, such as a muscle wasting disease,
paralysis, motor
neurone disease, cerebral palsy or myasthenia gravis
-
have a burn which requires medical treatment
-
ha
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Summary of Product characteristics
OBJECT 1
CISATRACURIUM 2 MG/ML SOLUTION FOR
INJECTION/INFUSION
Summary of Product Characteristics Updated 10-Apr-2018 | Hospira UK
Ltd
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 2.7 mg per 1 ml
One vial of 2.5 ml contains 5 mg of cisatracurium as cisatracurium
besilate 6.7 mg
One vial of 5 ml contains 10 mg of cisatracurium as cisatracurium
besilate 13.4 mg
One vial of 10 ml contains 20 mg of cisatracurium as cisatracurium
besilate 26.8 mg
For the full list of excipients, see section 6.1
3. Pharmaceutical form
Solution for injection/infusion
Colourless to pale yellow or greenish yellow solution
pH: 3.0 – 3.7
Osmolarity: 8 mOsmol/l
4. Clinical particulars
4.1 Therapeutic indications
Cisatracurium is indicated for use during surgical and other
procedures and in intensive care in adults and
children aged 1 month and over. It 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.
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
requirements.
USE BY INTRAVENOUS BOLUS
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