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Φάρμακα Δραστικές ουσίες Συμπληρώματα διατροφής Έλεγχος συγχορήγησης Νόσοι ICD-10
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Βιβλιογραφική αναφορά

Προτάσεις

SPC, UK: Nimbex Injection 2mg/ml (2012)

Εκδότης

Εκδότης GlaxoSmithKline UK
Διεύθυνση Stockley Park West, Uxbridge, Middlesex, UB11 1BT
Σφάλμα Για την προβολή της πλήρους καταχώρησης χρειάζεται να έχετε συνδρομή σε ισχύ (αγορά συνδρομής).
Ολοκληρώνοντας τη διαδικασία δωρεάν εγγραφής θα αποκτήσετε, χωρίς καμία δέσμευση εκ μέρους σας, συνδρομή διάρκειας 30 ημερών.

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. ...

Pharmaceutical form

Solution for injection/infusion. Colourless to pale yellow or greenish yellow solution. Practically free ...

Clinical particulars

Nimbex is an intermediate-duration, non-depolarising neuromuscular blocking agent for intravenous administration. ...

Therapeutic indications

Nimbex is indicated for use during surgical and other procedures and in intensive care in adults and ...

Posology and method of administration

Nimbex should only be administered by or under the supervision of anaesthetists or other clinicians who ...

Contraindications

Nimbex is contra-indicated in patients known to be hypersensitive to cisatracurium, atracurium, or benzenesulfonic ...

Special warnings and precautions for use

Product specific topics Cisatracurium paralyses the respiratory muscles as well as other skeletal muscles ...

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 ...

Pregnancy and lactation

There are no adequate data from the use of Nimbex in pregnant women. Animal studies are insufficient ...

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 ...

Undesirable effects

Data from pooled internal clinical trials were used to determine the frequency of very common to uncommon ...

Overdose

Symptoms and signs Prolonged muscle paralysis and its consequences are expected to be the main signs ...

Pharmacodynamic properties

Cisatracurium is a neuromuscular blocking agent. ATC code: M03AC11 Cisatracurium is an intermediate-duration, ...

Pharmacokinetic properties

Cisatracurium undergoes degradation in the body at physiological pH and temperature by Hofmann elimination ...

Preclinical safety data

Acute toxicity Meaningful acute studies with cisatracurium could not be performed. For symptoms of toxicity ...

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 Ringer ...

Shelf life

Shelf life before dilution: 2 years. Chemical and physical in-use stability has been demonstrated for ...

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 ...

Nature and contents of container

Nimbex 2mg/ml solution for injection/infusion. 2.5ml in ampoule (glass): box of 5 5ml in ampoule (glass): ...

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 ...

Marketing authorization holder

The Wellcome Foundation Limited 980 Great West Road Brentford Middlesex TW8 9GS United Kingdom Trading ...

Marketing authorization number(s)

PL 00003/0364

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

6 November 2012
Απαγορεύεται η αναπαραγωγή και αναδιανομή. Το έργο επεξεργασίας των παραπάνω πληροφοριών αποτελεί πνευματική ιδιοκτησία της Ergobyte Πληροφορική Α.Ε. και προστατεύεται από τη νομοθεσία περί πνευματικών δικαιωμάτων.