Cisatracurium besilate 20mg/10ml solution for injection ampoules

Maa: Yhdistynyt kuningaskunta

Kieli: englanti

Lähde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiivinen ainesosa:

Cisatracurium besilate

Saatavilla:

Viatris UK Healthcare Ltd

ATC-koodi:

M03AC11

INN (Kansainvälinen yleisnimi):

Cisatracurium besilate

Annos:

2mg/1ml

Lääkemuoto:

Solution for injection

Antoreitti:

Intravenous

luokka:

No Controlled Drug Status

Prescription tyyppi:

Valid as a prescribable product

Tuoteyhteenveto:

BNF: 15010500; GTIN: 5016695005317

Pakkausseloste

1
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 TAKING 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.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if
their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist or
nurse. This includes any possible side
effects not listed in this leaflet.
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
DO NOT USE CISATRACURIUM

if you are allergic (hypersensitive) to cisatracurium, any other
muscle relaxant or any other ingredients
in Cisatracurium (listed in section 6);

if you have reacted badly to an anaesthetic before.
Do not have Cisatracurium if any of the above apply to you. If you are
not sure, talk to your doctor, nurse or
pharmacist before you take Cisatracurium.
WARNINGS AND PRECAUTIONS
Talk to your doctor, nurse or pharmacist before you are given this
medicine if:

you h

Valmisteyhteenveto

OBJECT 1
CISATRACURIUM 2MG/ML SOLUTION FOR
INJECTION/INFUSION
Summary of Product Characteristics Updated 18-May-2017 | Generics UK
T/A Mylan
1. Name of the medicinal product
Cisatracurium 2mg/ml solution for injection/infusion
2. Qualitative and quantitative composition
Cisatracurium 2 mg as cisatracurium besylate 2.68 mg per 1 ml
One ampoule of 2.5ml contains 5 mg of cisatracurium
One ampoule of 5 ml contains 10 mg of cisatracurium
One ampoule of 10 ml contains 20 mg of cisatracurium
Excipient(s):
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for injection/infusion.
Colourless to pale yellow or greenish yellow clear solution.
The pH is between 3.25 and 3.65
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