PROPOVEN Emulsion for injection/infusion (2018)
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Περιεχόμενα
1. Name of the medicinal product
Propoven 1% emulsion for injection/infusion in pre-filled syringe.
2. Qualitative and quantitative composition
Each ml emulsion contains 10 mg propofol. Each 10 ml pre-filled syringe contains 100 mg propofol. Each 20 ml pre-filled syringe contains 200 mg propofol. Each 50 ml pre-filled syringe contains 500 mg ...
3. Pharmaceutical form
Emulsion for injection/infusion in pre-filled syringe. White oil-in-water emulsion. pH of emulsion: 7.5-8.5 Osmolality of emulsion: 300 mosmol/kg
4.1. Therapeutic indications
Propoven 1% is a short-acting intravenous general anaesthetic for: induction and maintenance of general anaesthesia in adults, adolescents and children >1 month sedation for diagnostic and surgical procedures, ...
4.2. Posology and method of administration
Propoven 1% must only be given in hospitals or adequately equipped day therapy units by physicians trained in anaesthesia or in the care of patients in intensive care. Circulatory and respiratory functions ...
4.3. Contraindications
Propofol is contraindicated in patients with a known hypersensitivity to propofol or any of the excipients listed in section 6.1. Propoven 1% contains soya oil and should not be used in patients who are ...
4.4. Special warnings and precautions for use
Propofol 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 maintenance ...
4.5. Interaction with other medicinal products and other forms of interaction
Propofol 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 ...
4.6. Pregnancy and lactation
Pregnancy The safety of propofol during pregnancy has not been established. Propofol should not be given to pregnant women except when absolutely necessary. Propofol crosses the placenta and can cause ...
4.7. Effects on 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 time after use of propofol. After administration of Propoven 1%, the patient ...
4.8. Undesirable effects
Induction and maintenance of anaesthesia or sedation with propofol is generally smooth with minimal evidence of excitation. The most commonly reported ADRs are pharmacologically predictable side effects ...
4.9. Overdose
Accidental overdosage is likely to cause cardiorespiratory depression. Respiratory depression should be treated by artificial ventilation with oxygen. Cardiovascular depression may require lowering of ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Anaesthetics; Other general anaesthetics <b>ATC-Code:</b> N01AX10 Mechanism of action / Pharmacodynamic effects Propofol (2,6-diisopropylphenol) is a short-acting general ...
5.2. Pharmacokinetic properties
Absorption Propofol is bound to plasma proteins for 98%. Following intravenous administration the pharmacokinetics of propofol can be described by a 3-compartment model. Distribution / Biotransformation ...
5.3. Preclinical safety data
Preclinical data reveal no special hazard for humans based on conventional studies on repeated dose toxicity or genotoxicity. Carcinogenicity studies have not been conducted. Teratogenic effects have not ...
6.1. List of excipients
Soya-bean oil, refined Medium-chain triglycerides Purified egg phosphatides Glycerol Oleic acid Sodium hydroxide Water for injections
6.2. Incompatibilities
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
6.3. Shelf life
Shelf life of the medicinal product in its original package before opening: 2 years. Shelf life after first opening: Medicinal product must be used immediately after first opening. Administration systems ...
6.4. Special precautions for storage
Do not store above 25°C. Do not freeze.
6.5. Nature and contents of container
10 ml pre-filled syringe (cyclo-olefine-copolymer) with bromobutyl tip cap, bromobutyl plunger and PP piston rod. 20 ml pre-filled syringe (cyclo-olefine-copolymer) with bromobutyl tip cap, bromobutyl ...
6.6. Special precautions for disposal and other handling
Propoven 1% should not be mixed prior to administration with injection or infusion solutions other than glucose 50 mg/ml (5%) solution for injection or sodium chloride 9 mg/ml (0.9%) solution for injection ...
7. Marketing authorization holder
Fresenius Kabi Deutschland GmbH, Else-Kroener Strasse 1, Bad Homburg v.d.H 61352, Germany
8. Marketing authorization number(s)
PA2059/017/004
9. Date of first authorization / renewal of the authorization
Date of First Authorisation: 18th April 2013 Date of Last Renewal: 12th March 2018
10. Date of revision of the text
September 2021
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