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DIPRIVAN Emulsion for injection or infusion (2019)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Diprivan 10 mg/ml (1%) emulsion for injection or infusion.

Qualitative and quantitative composition

Propofol 10 mg/ml. Excipient(s) with known effect: Soya-bean Oil, Refined Ph Eur For the full list of excipients, see section 6.1.

Pharmaceutical form

Emulsion for injection or infusion. White aqueous isotonic oil-in-water emulsion.

Therapeutic indications

Diprivan 1% is a short-acting intravenous general anaesthetic for: Induction and maintenance of general anaesthesia in adults and children >1 month. Sedation for diagnostic and surgical procedures, alone ...

Posology and method of administration

Posology For specific guidance relating to the administration of Diprivan 1% with a target controlled infusion (TCI) device, which incorporates Diprifusor TCI Software, see Section 4.2.5. Such use is restricted ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Diprivan 1% contains soya oil and should not be used in patients who are hypersensitive to peanut or soya. Diprivan ...

Special warnings and precautions for use

Diprivan 1% should be given by those trained in anaesthesia (or, where appropriate, doctors trained in the care of patients in Intensive Care). Patients should be constantly monitored and facilities for ...

Interaction with other medicinal products and other forms of interaction

Diprivan 1% has been used in association with spinal and epidural anaesthesia and with commonly used premedicants, neuromuscular blocking drugs, inhalational agents and analgesic agents; no pharmacological ...

Fertility, pregnancy and lactation

Pregnancy The safety of Diprivan 1% during pregnancy has not been established. Studies in animals have shown reproductive toxicity (see section 5.3). Diprivan 1% should not be given to pregnant women except ...

Effects on ability to drive and use machines

Diprivan 1% has moderate influence on the ability to drive and use machines. Patients should be advised that performance at skilled tasks, such as driving and operating machinery, may be impaired for some ...

Undesirable effects

General Induction and maintenance of anaesthesia or sedation is generally smooth with minimal evidence of excitation. The most commonly reported ADRs are pharmacologically predictable side effects of an ...

Overdose

Accidental overdosage is likely to cause cardiorespiratory depression. Respiratory depression should be treated by artificial ventilation with oxygen. Cardiovascular depression would require lowering of ...

Pharmacodynamic properties

Pharmacotherapeutic group: Other general anaesthetics ATC code: N01AX10 Mechanism of action Propofol (2, 6-diisopropylphenol) is a short-acting general anaesthetic agent with a rapid onset of action of ...

Pharmacokinetic properties

Absorption When Diprivan 1% is used to maintain anaesthesia, blood concentrations asymptotically approach the steady-state value for the given administration rate. Distribution Propofol is extensively ...

Preclinical safety data

Published studies in animals (including primates) at doses resulting in light to moderate anaesthesia demonstrate that the use of anaesthetic agents during the period of rapid brain growth or synaptogenesis ...

List of excipients

Glycerol Ph Eur Purified egg phosphatide Sodium hydroxide Ph Eur Soya-bean oil, refined Ph Eur Water for injections Ph Eur Nitrogen Ph Eur Disodium edetate Ph Eur

Incompatibilities

The neuromuscular blocking agents, atracurium and mivacurium should not be given through the same intravenous line as Diprivan 1% without prior flushing.

Shelf life

Shelf life Shelf life of the product as packaged for sale: Ampoules: 3 years. Vials: 3 years. Pre-filled syringe: 2 years. Shelf life after dilution: Use of diluted Diprivan must begin immediately following ...

Special precautions for storage

Store between 2°C and 25°C. Do not freeze.

Nature and contents of container

a) Clear neutral glass ampoules of 20 ml in boxes of 5 b) Clear neutral glass vials of 50 ml and 100 ml c) Type 1 glass pre-filled syringe of 50 ml

Special precautions for disposal and other handling

In-use precautions Containers should be shaken before use. Any portion of the contents remaining after use should be discarded. Diprivan 1% should not be mixed prior to administration with injections or ...

Marketing authorization holder

Aspen Pharma Trading Limited, 3016 Lake Drive, Citywest Business Campus, Dublin 24, Ireland

Marketing authorization number(s)

PL 39699/0074

Date of first authorization / renewal of the authorization

Date of first authorisation: 15<sup>th</sup> April 1986 Date of latest renewal: 24<sup>th</sup> September 2004

Date of revision of the text

04/2019

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