Nimbex 2mg/ml solution for injection/infusion

Land: Irland

Sprache: Englisch

Quelle: HPRA (Health Products Regulatory Authority)

Wirkstoff:

Cisatracurium Besilate

Verfügbar ab:

Aspen Pharma Trading Limited

ATC-Code:

M03AC; M03AC11

INN (Internationale Bezeichnung):

Cisatracurium Besilate

Dosierung:

2 milligram(s)/millilitre

Darreichungsform:

Solution for injection/infusion

Verschreibungstyp:

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

Therapiebereich:

Other quaternary ammonium compounds; cisatracurium

Berechtigungsstatus:

Marketed

Berechtigungsdatum:

1996-05-01

Gebrauchsinformation

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
NIMBEX 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.
-
If you get any side effects, talk to your doctor. This includes any
possible side effects not listed in this
leaflet. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What Nimbex is and what it is used for
2.
What you need to know before you are given Nimbex
3.
How Nimbex is given
4.
Possible side effects
5.
How to store Nimbex
6.
Contents of the pack and other information
1.
WHAT NIMBEX IS AND WHAT IT IS USED FOR
Nimbex contains a medicine called cisatracurium. This belongs to a
group of medicines called muscle
relaxants.
Nimbex 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 NIMBEX
DO NOT USE NIMBEX:
-
if you are allergic to cisatracurium, any other muscle relaxant or any
of the other ingredients of
Nimbex (listed in section 6)
-
if you have reacted badly to an anaesthetic before
Do not have Nimbex if any of the above apply to you. If you are not
sure, talk to your doctor, nurse or
pharmacist before you have Nimbex.
TAKE SPECIAL CARE WITH NIMBEX
Talk to your doctor, nurse or pharmacist before having this medicine:
-
if you have muscle weakness, tiredness or difficulty in co-ordinating
your movements (myasthenia
gravis)
-
if 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 are not sure if any of the above apply to you, talk to your

Fachinformation

Health Products Regulatory Authority
25 August 2021
CRN00CHCQ
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Nimbex 2mg/ml solution for injection/infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Cisatracurium 2 mg as cisatracurium besilate 2.68 mg per 1ml.
One ampoule of 2.5 ml 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
One ampoule 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.
Colourless to pale yellow or greenish yellow solution. Practically
free from visible particulate matter.
4 CLINICAL PARTICULARS
Nimbex is an intermediate-duration, non-depolarising neuromuscular
blocking agent for intravenous administration.
4.1 THERAPEUTIC INDICATIONS
Nimbex is indicated for use during surgical and other procedures in
adults and children aged 1 month and over. Nimbex is also
indicated for use in adults requiring intensive care. Nimbex 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
Nimbex should be only 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 Nimbex 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).
Nimbex 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