NIMBEX Solution for injection / infusion (2021)
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Περιεχόμενα
Name of the medicinal product
Nimbex 2mg/ml solution for injection/infusion.
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. ...
Pharmaceutical form
Solution for injection/infusion. Colourless to pale yellow or greenish yellow solution. Practically free from visible particulate matter. Nimbex is an intermediate-duration, non-depolarising neuromuscular ...
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 ...
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, ...
Contraindications
Nimbex is contra-indicated in patients known to be hypersensitive to cisatracurium, atracurium, or benzenesulfonic acid.
Special warnings and precautions for use
Product specific topics Cisatracurium paralyses the respiratory muscles as well as other skeletal muscles but has no known effect on consciousness or pain threshold. Nimbex should be only administered ...
Interaction with other medicinal products and other forms of interaction
Many drugs have been shown to influence the magnitude and/or duration of action of non-depolarising neuromuscular blocking agents, including the following:- <u>Increased Effect:</u> By anaesthetic agents ...
Fertility, pregnancy and lactation
Pregnancy There are no adequate data from the use of Nimbex in pregnant women. Animal studies are insufficient with respect to effects on pregnancy, embryonal/foetal development, parturition and postnatal ...
Effects on ability to drive and use machines
This precaution is not relevant to the use of Nimbex. Nimbex will always be used in combination with a general anaesthetic and therefore the usual precautions relating to performance of tasks following ...
Undesirable effects
Data from pooled internal clinical trials were used to determine the frequency of very common to uncommon adverse reactions. The following convention has been used for the classification of frequency:- ...
Overdose
h3, Symptoms and signs Prolonged muscle paralysis and its consequences are expected to be the main signs of overdosage with Nimbex. h3, Management It is essential to maintain pulmonary ventilation and ...
Pharmacodynamic properties
Mechanism of action Cisatracurium is a neuromuscular blocking agent, ATC code: M03AC11. Cisatracurium is an intermediate-duration, non-depolarising benzylisoquinolinium skeletal muscle relaxant. Pharmacodynamic ...
Pharmacokinetic properties
Biotransformation/Elimination Cisatracurium undergoes degradation in the body at physiological pH and temperature by Hofmann elimination (a chemical process) to form laudanosine and the monoquaternary ...
Preclinical safety data
Acute toxicity Meaningful acute studies with cisatracurium could not be performed. For symptoms of toxicity see section 4.9. Subacute Toxicity Studies with repeated administration for three weeks in dogs ...
List of excipients
Benzene sulfonic acid solution 32% w/v Water for injections
Incompatibilities
Degradation of cisatracurium besilate has been demonstrated to occur more rapidly in lactated Ringers Injection and 5% Dextrose and lactated Ringers Injection than in the infusion fluids listed under Section ...
Shelf life
Shelf life before dilution: 2 years. Chemical and physical in-use stability has been demonstrated for at least 24 hours at 5°C and 25°C (see section 6.6). From a microbiological point of view, the product ...
Special precautions for storage
Store in a refrigerator (2°C to 8°C). Do not freeze. Store in the original package in order to protect from light For storage conditions of the diluted medicinal product see section 6.3.
Nature and contents of container
<u>Nimbex 2mg/ml solution for injection/infusion:</u> 2.5ml in ampoule (glass): box of 5. 5ml in ampoule (glass): box of 5. 10ml in ampoule (glass): box of 5. 25ml in ampoule (glass: box of 2. Type I, ...
Special precautions for disposal and other handling
This product is for single use only. Use only clear and almost colourless up to slightly yellow/greenish yellow coloured solutions. The product should be visually inspected before use, and if the visual ...
Marketing authorization holder
Aspen Pharma Trading Limited, 3016 Lake Drive, City West Business Campus, Dublin 24, Ireland Service-Tel: 0800 008 7392 (+44 1748 828 391)
Marketing authorization number(s)
PL 39699/0092
Date of first authorization / renewal of the authorization
Date of first authorisation: 07 August 1995 Date of last renewal: 09 August 2010
Date of revision of the text
September 2021
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