Nimbex 5mg/2.5ml solution for injection ampoules

Maa: Yhdistynyt kuningaskunta

Kieli: englanti

Lähde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiivinen ainesosa:

Cisatracurium besilate

Saatavilla:

GlaxoSmithKline UK 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

Pakkausseloste

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[ASPEN LOGO]
INFORMATION FOR THE PHYSICIAN
NIMBEX
CISATRACURIUM
PLEASE REFER TO THE SUMMARY OF PRODUCT CHARACTERISTICS (SPC) FOR
FURTHER DETAILS ON THIS
PRODUCT.
TRADE NAME OF THE MEDICINAL PRODUCT
Nimbex 2 mg/ml solution for injection/infusion
Nimbex Forte 5 mg/ml solution for injection/infusion
QUALITATIVE AND QUANTITATIVE COMPOSITION
Nimbex 2 mg/ml, solution for injection:
Cisatracurium 2 mg as cisatracurium besilate 2.68 mg per 1 ml
one ampoule of 10 ml contains 20 mg of cisatracurium
one ampoule of 25 ml contains 50 mg of cisatracurium
Nimbex Forte 5 mg/ml, solution for injection:
Cisatracurium 5 mg as cisatracurium besilate 6.70 mg per 1 ml
one vial of 30 ml contains 150 mg of cisatracurium
PHARMACEUTICAL FORM
Solution for injection/infusion.
Colourless to pale yellow or greenish yellow solution. Practically
free from visible particulate
matter.
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.
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.
Nimbex contains no antimicrobial preservative and is intended for
single patient use.
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MONITORING ADVICE
As with other neuromuscular blocking agents, monitoring of
neuromuscular function is
recommended during the use of Ni

Valmisteyhteenveto

OBJECT 1
NIMBEX INJECTION 2MG/ML
Summary of Product Characteristics Updated 03-Aug-2017 | Aspen
1. Name of the medicinal product
Nimbex 2mg/ml solution for injection/infusion.
2. Qualitative and quantitative composition
Cisatracurium 2mg as cisatracurium besilate 2.68mg per 1ml
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 ampoule of 25ml contains 50mg 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 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 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 Nimbex in order to i