Source: Health Products Regulatory Authority (IE) Revision Year: 2018 Publisher: Fresenius Kabi Deutschland GmbH, Else-Kroener Strasse 1, Bad Homburg v.d.H 61352, Germany
Propoven 1% is a short-acting intravenous general anaesthetic for:
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 should be constantly monitored (e.g. ECG, pulse oxymetry) and facilities for maintenance of patient airways, artificial ventilation, and other resuscitation facilities should be immediately available at all times. For sedation during surgical and diagnostic procedures Propoven 1% should not be administered by the same person conducting the surgical or diagnostic procedure.
The dose of Propoven 1% should be individualised based on the response of the patient and premedications used. Supplementary analgesic agents are generally required in addition to Propoven 1%.
For induction of anaesthesia Propoven 1% should be titrated (approximately 20-40 mg propofol every 10 seconds) against the response of the patient until clinical signs show the onset of anaesthesia.
Most adult patients aged less than 55 years are likely to require 1.5 to 2.5 mg propofol/kg bodyweight.
In patients over this age and in patients of ASA grades III and IV, especially those with impaired cardiac function, the requirements will generally be less and the total dose of Propoven 1% may be reduced to a minimum of 1 mg propofol/kg bodyweight. Lower rates of administration of Propoven 1% should be used (approximately 2 ml of the 10 mg/ml emulsion (20 mg propofol) every 10 seconds).
Anaesthesia can be maintained by administering Propoven 1% either by continuous infusion or repeat bolus injections.
For maintenance of anaesthesia generally doses of 4 to 12 mg propofol/kg bodyweight/h should be given. A reduced maintenance dose of approximately 4 mg propofol/kg bodyweight/h may be sufficient during less stressful surgical procedures such as minimal invasive surgery.
In elderly patients, patients in unstable general conditions, patients with impaired cardiac function or hypovolaemic patients and patients of ASA grades III and IV the dosage of Propoven 1% may be reduced further depending on the severity of the patient’s condition and on the performed anaesthetic technique.
For maintenance of anaesthesia with Propoven 1% using repeat bolus injections dose increments of 25 to 50 mg propofol (= 2.5-5 ml Propoven 1%) should be given according to clinical requirements.
Rapid bolus administration (single or repeated) with Propoven 1% should not be used in the elderly as this may lead to cardiopulmonary depression.
For induction of anaesthesia Propoven 1% should be titrated slowly until clinical signs show the onset of anaesthesia. The dose should beadjusted according to age and/or bodyweight. Most patients over 8 years of age require approximately 2.5 mg/kg bodyweight Propoven 1% for induction of anaesthesia. In younger children, especially between the age of 1 month and 3 years, dose requirements may be higher (2.5–4 mg/kg bodyweight).
Anaesthesia can be maintained by administering Propoven 1% by infusion or repeated bolus injection to maintain the depth of anaesthesia required. The required rate of administration varies considerably between patients but rates in the region of 9-15 mg/kg/h usually achieve satisfactory anaesthesia. In younger children, especially between the age of 1 month and 3 years, dose requirements may be higher.
For ASA III and IV patients lower doses are recommended (see also section 4.4).
To provide sedation during surgical and diagnostic procedures, doses and administration rates should be adjusted according to the clinical response. Most patients will require 0.5-1 mg propofol/kg bodyweight over 1 to 5 minutes for onset of sedation. Maintenance of sedation may be accomplished by titrating Propoven 1% infusion to the desired level of sedation. Most patients will require 1.5-4.5 mg propofol/kg bodyweight/h. The infusion may be supplemented by bolus administration of 10-20 mg propofol (1-2 ml Propoven 1%) if a rapid increase of the depth of sedation is required.
In patients older than 55 years and in patients of ASA grades III and IV lower doses of Propoven 1% may be required and the rate of administration may need to be reduced.
Doses and administration rates should be adjusted according to the required depth of sedation and the clinical response. Most paediatric patients require 1-2 mg/kg bodyweight propofol for onset of sedation. Maintenance of sedation may be accomplished by titrating Propoven 1% infusion to the desired level of sedation. Most patients require 1.5-9 mg/kg/h propofol. With Propoven 1% the infusion may be supplemented by bolus administration of up to 1 mg/kg bodyweight if a rapid increase of depth of sedation is required.
In ASA III and IV patients lower doses may be required.
When used to provide sedation for ventilated patients under intensive care conditions, it is recommended that Propoven 1% should be given by continuous infusion. The dose should be adjusted according to the depth of sedation required. Usually satisfactory sedation is achieved with administration rates in the range of 0.3 to 4.0 mg propofol/kg bodyweight/h. Rates of infusion greater than 4.0 mg propofol/kg bodyweight/h are not recommended (see section 4.4).
Administration of propofol by a target controlled infusion (TCI) system is not advised for sedation in the intensive care unit (ICU).
The duration of administration must not exceed 7 days.
For intravenous use.
For single use only. Any unused emulsion must be discarded.
Pre-filled syringes should be shaken before use.
If two layers can be seen after shaking the emulsion should not be used.
Use only homogeneous preparations and undamaged pre-filled syringes.
Propoven 1% can be used for infusion undiluted or diluted (for dilution see section 6.6).
When Propoven 1% is infused, it is recommended that equipment such as burettes, drop counter, syringe pumps (including TCI systems) or volumetric infusion pumps should always be used to control infusion rates.
Propoven 1% is a lipid containing emulsion without antimicrobial preservatives and may support rapid growth of micro-organisms.
The emulsion must be drawn aseptically into a giving set immediately after opening the syringe. Administration must commence without delay.
Asepsis must be maintained for both Propoven 1% and infusion equipment throughout the infusion period. Co-administration of other medicinal products or fluids added to the Propoven 1% infusion line must occur close to the cannula site using a Y-piece connector or a three-way valve. For instructions on co-administration of the medicinal product, see section 6.6.
Propoven 1% must not be administered via a microbiological filter.
Propoven 1% and any infusion equipment containing Propoven 1% are for single administration in an individual patient. After use remaining solution of Propoven 1% has to be discarded.
As usual for fat emulsions, the infusion of undiluted Propoven 1% via one infusion system must not exceed 12 hours. After 12 hours, the infusion system and reservoir of Propoven 1% must be discarded or replaced if necessary.
For administering infusion of diluted Propoven 1%, burettes, drop counters or infusion pumps should always be used to control infusion rates and to avoid the risk of accidentally uncontrolled infusion of large volumes of diluted Propoven 1%. This risk has to be taken into account when the decision for the maximum dilution in the burette is made.
To reduce pain on the injection site, lidocaine may be injected immediately before the use of Propoven 1% (see section 4.4). Alternatively, Propoven 1% may be mixed, immediately for use, with preservative free lidocaine injection (20 parts of Propoven 1% with up to 1 part of 1% lidocaine injection solution under controlled and validated aseptical conditions. The mixture has to be administered within 6 hours after preparation.
Muscle relaxants like atracurium and mivacurium should only be administered after flush of the same infusion site used for Propoven 1%.
Propoven 1% will be injected into a vein either manually or by electric pumps. In case of using electronic pumps, appropriate compatibility should be ensured.
10 ml and 20 ml glass syringes and 10 ml plastic syringes are suitable for manual use only and must not be used with a pump.
10 ml and 20 ml glass syringes must also not be used with needle-free connectors, except standard tubing or 3-way stopcocks to avoid breakage or clogging of the connector.
If breakage/clogging are observed, the pre-filled syringe must be disposed and a new one must be used.
Sterility has to be ensured. The outer surface of the syringe and the plunger rod are not sterile.
Administration of Propoven 1% by a Target Controlled Infusion system is restricted to induction and maintenance of general anaesthesia in adults. It is not recommended for use in ICU sedation or sedation for surgical and diagnostic procedures. Propoven 1% may be administered by a Target Controlled Infusion system incorporating appropriate Target Controlled Infusion software. Users must be familiar with the infusion pump users' manual, and with the administration of Propoven 1% by Target Controlled Infusion.
The system allows the anaesthetist or intensivist to achieve and control a desired speed of induction and depth of anaesthesia by setting and adjusting target (predicted) plasma and/or effect-side concentrations of propofol. Different modalities of the various pump systems should be considered i.e. the Target Controlled Infusion system might assume that the initial blood propofol concentration in the patient is zero. Therefore, in patients who have received prior propofol, there may be a need to select a lower initial target concentration when commencing Target Controlled Infusion. Similarly, the immediate recommencement of Target Controlled Infusion is not recommended if the pump has been switched off.
Guidance on propofol target concentrations is given below. In view of interpatient variability in propofol pharmacokinetics and pharmacodynamics, in both premedicated and unpremedicated patients the target propofol concentration should be titrated against the response of the patient in order to achieve the depth of anaesthesia required.
In adult patients under 55 years of age anaesthesia can usually be induced with target propofol concentrations in the region of 4-8 microgram/ml. An initial target of 4 microgram/ml is recommended in premedicated patients and in unpremedicated patients an initial target of 6 microgram/ml is advised. Induction time with these targets is generally within the range of 60–120 seconds. Higher targets will allow more rapid induction of anaesthesia but may be associated with more pronounced haemodynamic and respiratory depression.
A lower initial target concentration should be used in patients over the age of about 55 years and in patients of ASA grades 3 and 4. The target concentration can then be increased in steps of 0.5-1.0 microgram/ml at intervals of 1 minute to achieve a gradual induction of anaesthesia.
Supplementary analgesia will generally be required and the extent to which target concentrations for maintenance of anaesthesia can be reduced will be influenced by the amount of concomitant analgesia administered. Target propofol concentrations in the region of 3–6 microgram/ml usually maintain satisfactory anaesthesia.
The predicted propofol concentration on waking is generally in the region of 1.0-2.0 microgram/ml and will be influenced by the amount of analgesia given during maintenance.
Target blood propofol concentration settings in the range of 0.2-2.0 microgram/ml will generally be required. Administration should begin at low target setting which should be titrated against the response of the patient to achieve the depth of sedation desired.
Accidental overdosage is likely to cause cardiorespiratory depression. Respiratory depression should be treated by artificial ventilation with oxygen. Cardiovascular depression may require lowering of the patient’s head and, if severe, use of plasma expanders and pressor agents.
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 with undiluted Propoven 1% should be replaced after 12 hours.
Shelf life after dilution: Medicinal product must be used immediately after dilution. The administration should be completed within 6 hours after dilution.
Do not store above 25°C. Do not freeze.
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 plunger and PP piston rod.
50ml pre-filled syringe (cyclo-olefine-copolymer) with bromobutyl tip cap, bromobutyl plunger and PP piston rod.
Packs containing 6 plastic syringes with 10 ml emulsion
Packs containing 6 plastic syringes with 20 ml emulsion.
Packs containing 1 plastic syringe with 50 ml emulsion.
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 or preservative free lidocaine 10 mg/ml (1%) solution for injection. The maximum dilution must not exceed 1 part of Propoven 1% with 4 parts of glucose 50 mg/ml (5%) solution for injection or sodium chloride 9 mg/ml (0.9%) solution for injection (minimum concentration 2 mg propofol/ml). The mixture should be prepared aseptically (controlled and validated conditions preserved) immediately prior to administration and must be administered within 6 hours after preparation (see also section 4.2.). Final propofol concentration must not be below 2 mg/ml.
Co-administration of a glucose 50 mg/ml (5 %) solution for injection or sodium chloride 9 mg/ml (0.9 %) solution for injection or sodium chloride 1.8 mg/ml (0.18 %) solution for injection and glucose 40 mg/ml (4 ) solution for injection with Propoven 1 is permitted via a Y-piece connector close to the injection site.
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
