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 Περιεχόμενα  Φάρμακα Α - Ζ  Συγχορήγηση

BRIDION Solution for injection (2019)

Αναφορές

Βιβλιογραφική αναφορά

Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
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Περιεχόμενα

Name of the medicinal product

Bridion 100 mg/mL solution for injection.

Qualitative and quantitative composition

1 mL contains sugammadex sodium equivalent to 100 mg sugammadex. Each vial of 2 mL contains sugammadex sodium equivalent to 200 mg sugammadex. Each vial of 5 mL contains sugammadex sodium equivalent to ...

Pharmaceutical form

Solution for injection (injection). Clear and colourless to slightly yellow solution. The pH is between 7 and 8 and osmolality is between 300 and 500 mOsm/kg.

Therapeutic indications

Reversal of neuromuscular blockade induced by rocuronium or vecuronium in adults. For the paediatric population: sugammadex is only recommended for routine reversal of rocuronium induced blockade in children ...

Posology and method of administration

Posology Sugammadex should only be administered by, or under the supervision of an anaesthetist. The use of an appropriate neuromuscular monitoring technique is recommended to monitor the recovery of neuromuscular ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Special warnings and precautions for use

As is normal post-anaesthetic practice following neuromuscular blockade, it is recommended to monitor the patient in the immediate post-operative period for untoward events including recurrence of neuromuscular ...

Interaction with other medicinal products and other forms of interaction

The information in this section is based on binding affinity between sugammadex and other medicinal products, non-clinical experiments, clinical studies and simulations using a model taking into account ...

Fertility, pregnancy and lactation

Pregnancy For sugammadex no clinical data on exposed pregnancies are available. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonic/foetal development, ...

Effects on ability to drive and use machines

Bridion has no known influence on the ability to drive and use machines.

Undesirable effects

Summary of the safety profile Bridion is administered concomitantly with neuromuscular blocking agents and anaesthetics in surgical patients. The causality of adverse events is therefore difficult to assess. ...

Overdose

In clinical studies, 1 case of an accidental overdose with 40 mg/kg was reported without any significant adverse reactions. In a human tolerance study sugammadex was administered in doses up to 96 mg/kg. ...

Pharmacodynamic properties

Pharmacotherapeutic group: all other therapeutic products, antidotes ATC code: V03AB35 Mechanism of action Sugammadex is a modified gamma cyclodextrin which is a Selective Relaxant Binding Agent. It forms ...

Pharmacokinetic properties

The sugammadex pharmacokinetic parameters were calculated from the total sum of non-complexbound and complex-bound concentrations of sugammadex. Pharmacokinetic parameters as clearance and volume of distribution ...

Preclinical safety data

Preclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity potential, and toxicity to reproduction, local tolerance ...

List of excipients

Hydrochloric acid 3.7% (to adjust pH) and/or sodium hydroxide (to adjust pH) Water for injections

Incompatibilities

This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6. Physical incompatibility has been reported with verapamil, ondansetron and ranitidine.

Shelf life

Shelf life: 3 years. After first opening and dilution chemical and physical in-use stability has been demonstrated for 48 hours at 2°C to 25°C. From a microbiological point of view, the diluted product ...

Special precautions for storage

Store below 30°C. Do not freeze. Keep the vial in the outer carton in order to protect from light. For storage conditions of the diluted medicinal product, see section 6.3.

Nature and contents of container

2 mL or 5 mL of solution in type I glass vial closed with chlorobutyl rubber stoppers with aluminium crimp-cap and flip-off seal. Pack sizes: 10 vials of 2 mL or 10 vials of 5 mL. Not all pack-sizes may ...

Special precautions for disposal and other handling

Bridion can be injected into the intravenous line of a running infusion with the following intravenous solutions: sodium chloride 9 mg/mL (0.9%), glucose 50 mg/mL (5%), sodium chloride 4.5 mg/mL (0.45%) ...

Marketing authorization holder

Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands

Marketing authorization number(s)

EU/1/08/466/001 EU/1/08/466/002

Date of first authorization / renewal of the authorization

Date of first authorisation: 25 July 2008 Date of latest renewal: 21 June 2013

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