PANCURONIUM BROMIDE Solution for injection (2018)
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Περιεχόμενα
Name of the medicinal product
Pancuronium Bromide 2 mg/ml Solution for Injection.
Qualitative and quantitative composition
Each 1 ml contains 2 mg of pancuronium bromide. Each ml also contains 0.15 mmol sodium. Each 2 ml ampoule contains 4 mg of pancuronium bromide. Each 2 ml ampoule also contains 0.3 mmol sodium. Excipient(s) ...
Pharmaceutical form
Solution for injection. Clear, colourless solution.
Therapeutic indications
The active substance of pancuronium bromide is an amino steroid which effectively blocks transmission of motor nerve impulses to the striated muscle receptors. It is a non-depolarising neuromuscular blocking ...
Posology and method of administration
Posology The use of a peripheral nerve stimulator is recommended for monitoring the neuromuscular block and recovery. Adult Initial dose: 50-80 micrograms/kg (intubation accomplished within 150-120 seconds) ...
Contraindications
Hypersensitivity to pancuronium or the bromide ion or to any of the excipients listed in section 6.1. Concurrent use of a depolarising neuromuscular blocking agent e.g. suxamethonium.
Special warnings and precautions for use
Warnings Anaphylactic reactions can occur following the administration of neuromuscular blocking agents. Precautions for treating such reactions should always be taken. (see section 4.8). Particularly ...
Interaction with other medicinal products and other forms of interaction
Suxamethonium. Used prior to pancuronium bromide (for endotracheal intubation) enhances the relaxation effect of the pancuronium bromide and the duration of action. Therefore administration of pancuronium ...
Pregnancy and lactation
The use of pancuronium bromide in pregnant or breast feeding women with respect to safety has not been established. Therefore the drug should only be administered to pregnant women or lactating women when ...
Effects on ability to drive and use machines
It is not recommended to use potentially dangerous machinery or drive a car within 24 hours after full recovery from the neuromuscular blocking action of pancuronium bromide.
Undesirable effects
High doses of a depolarising drug may cause end-plate desensitisation and prolong post-operative apnoea. Cardiac disorders and vascular disorders: Increased pulse rate and cardiac output. Blood pressure ...
Overdose
Clinical features The symptoms are those of prolonged apnoea, respiratory depression and/or muscle weakness. Death may follow acute respiratory failure. Management Neostigmine at a dose of 2.5mg and Atropine ...
Pharmacodynamic properties
Pharmacotherapeutic group: Muscle relaxants, peripherally acting agents, other quaternary ammonium compounds ATC code: M03AC01 Mechanism of action Pancuronium bromide produces pharmacologic effects similar ...
Pharmacokinetic properties
Absorption Following I/V administration of pancuronium bromide 60 micrograms/kg, muscle relaxation reaches a level suitable for endotracheal intubation within 2-3 minutes, slightly more rapidly than with ...
Preclinical safety data
None.
List of excipients
Sodium chloride Sodium acetate Water for injections
Incompatibilities
Do not mix other solutions in the same syringe as a change in pH can cause precipitation.
Shelf life
Shelf life: 2 years.
Special precautions for storage
Store in a refrigerator (2°C-8°C). Do not freeze. Keep the ampoule in the outer carton in order to protect from light.
Nature and contents of container
2ml Type I clear glass ampoules. Pack sizes of 5, 10 and 50. Not all pack sizes may be marketed.
Special precautions for disposal and other handling
For single use only. Discard any unused contents. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
Hospira UK Limited, Horizon, Honey Lane, Hurley, Maidenhead, SL6 6RJ, UK
Marketing authorization number(s)
PL 04515/0062
Date of first authorization / renewal of the authorization
Date of first authorisation: 07/02/1997 Date of last renewal: 12/02/2003
Date of revision of the text
10/2018
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