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SPC, UK: Tracrium Injection (2011)

Αναφορές

Βιβλιογραφική αναφορά

Στοιχεία εκδότη

Εκδότης :
GlaxoSmithKline UK
Διεύθυνση :
Stockley Park West, Uxbridge, Middlesex, UB11 1BT
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Δωρεάν εγγραφή

Name of the medicinal product

Tracrium Injection.

Qualitative and quantitative composition

Atracurium Besilate HSE 10mg/ml.

Pharmaceutical form

Injection.

Therapeutic indications

Tracrium is a highly selective, competitive or non-depolarising neuromuscular blocking agent. It is used as an adjunct to general anaesthesia or sedation in the intensive care unit (ICU), to relax skeletal ...

Posology and method of administration

Route of administration: Intravenous injection or continuous infusion. Used by injection in adults: Tracrium is administered by intravenous injection. The dosage range recommended for adults is 0.3 to ...

Contraindications

Atracurium is contraindicated in patients known to be hypersensitive to atracurium, cisatracurium or benzenesulfonic acid.

Special warnings and precautions for use

Precautions: In common with all the other neuromuscular blocking agents, Tracrium paralyses the respiratory muscles as well as other skeletal muscles but has no effect on consciousness. Tracrium should ...

Interaction with other medicinal products and other forms of interaction

The neuromuscular block produced by Tracrium may be increased by the concomitant use of inhalational anaesthetics such as halothane, isoflurane and enflurane. In common with all non-depolarising neuromuscular ...

Fertility, pregnancy and lactation

Fertility studies have not been performed. Animal studies have indicated that Tracrium has no significant effects on foetal development. In common with all neuromuscular blocking agents, Tracrium should ...

Effects on ability to drive and use machines

This precaution is not relevant to the use of atracurium. Atracurium will always be used in combination with a general anaesthetic and therefore the usual precautions relating to performance of tasks following ...

Undesirable effects

The most commonly reported adverse reactions during treatment are hypotension (mild, transient) and skin flushing, these events are attributed to histamine release. Very rarely, severe anaphylactoid or ...

Overdose

Prolonged muscle paralysis and its consequences are the main signs of overdosage. Treatment It is essential to maintain a patient airway together with assisted positive pressure ventilation until spontaneous ...

Pharmacodynamic properties

Atracurium is a highly selective competitive (non-depolarising) neuromuscular blocking agent with an intermediate duration of action. Non-depolarising agents antagonise the neurotransmitter action of acetylcholine ...

Pharmacokinetic properties

The pharmacokinetics of Atracurium in man are essentially linear with the 0.3-0.6 mg/kg dose range. The elimination half-life is approximately 20 minutes, and the volume of distribution is 0.16 L/kg. Atracurium ...

Preclinical safety data

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SmPC.

List of excipients

Benzene Sulphonic acid Water for Injections

Incompatibilities

None.

Shelf life

24 months.

Special precautions for storage

Store between 2 and 8°C. Do not freeze. Keep container in the outer carton. Any unused Tracrium from opened ampoules or vials should be discarded.

Nature and contents of container

Neutral glass ampoules or vials. Vials are closed with a rubber stopper, sealed with an aluminium collar and fitted with a plastic flip-off top. Pack sizes: Boxes of 5 2.5ml ampoules, 5 5ml ampoules ...

Special precautions for disposal and other handling

None.

Marketing authorization holder

The Wellcome Foundation Ltd trading as: GlaxoSmithKline UK Stockley Park West Uxbridge Middlesex UB11 1BT Glaxo Wellcome House Berkeley Avenue Greenford Middlesex UB6 ONN

Marketing authorization number(s)

PL0003/0166

Date of first authorization / renewal of the authorization

12th January 1999, 5th December 2008

Date of revision of the text

1 July 2011