Propofol-Lipuro

Propofol.

1 ml of emulsion contains 10 mg of propofol.
Propofol-Lipuro 200 mg/20 mL ampoule: One ampoule of 20 ml contains 200 mg of propofol.
Excipients/Inactive Ingredients: Refined soya-bean oil 50 mg/ml, medium-chain triglycerides, glycerol, egg lecithin, sodium oleate, equivalent to 0.03 mg sodium/ml, water for injections.
Propofol-Lipuro 500 mg/50 mL vial: One vial of 50 ml contains 500 mg of propofol.
Excipients with known effect: 1 ml of emulsion for injection or infusion contains soya-bean oil, refined 50 mg; sodium 0.03 mg.
Excipients/Inactive Ingredients: Refined soya-bean oil, medium-chain triglycerides, glycerol, egg lecithin, sodium oleate, water for injections.

Pharmacotherapeutic group: Other general anaesthetics. ATC code: N01AX10.
Pharmacology: Pharmacodynamics: Mechanism of action, pharmacodynamic effect: After intravenous injection of PROPOFOL-LIPURO EMULSION FOR INJECTION/INFUSION, onset of the hypnotic effect occurs rapidly. Depending on the rate of injection, the time to induction of anaesthesia is between 30 and 40 seconds. The duration of action after a single bolus administration is short due to the rapid metabolism and excretion (4 - 6 minutes).
With the recommended dosage schedule, a clinically relevant accumulation of propofol after repeated bolus injection or after infusion has not been observed.
Patients recover consciousness rapidly.
Bradycardia and hypotension occasionally occur during induction of anaesthesia probably due to a lack of vagolytic activity. The cardio-circulatory situation usually normalises during maintenance of anaesthesia.
Paediatric population: Limited studies on the duration of propofol based anaesthesia in children indicate safety and efficacy is unchanged up to duration of 4 hours. Literature evidence of use in children documents use for prolonged procedures without changes in safety or efficacy.
Pharmacokinetics: Distribution: After intravenous administration about 98 % of propofol is bound to plasma protein.
After intravenous bolus administration the initial blood level of propofol declines rapidly due to rapid distribution into different compartments (α-phase). The distribution half-life has been calculated as 2 - 4 minutes.
During elimination the decline of blood levels is slower. The elimination half-life during the β-phase is in the range of 30 to 60 minutes. Subsequently a third deep compartment becomes apparent, representing the redistribution of propofol from weakly perfused tissue.
The central volume of distribution is in the range of 0.2 - 0.79 l/kg body weight, the steady-state volume of distribution in the range of 1.8 - 5.3 l/kg body weight.
Biotransformation: Propofol is mainly metabolized in the liver to form glucuronides of propofol and glucuronides and sulphate conjugates of its corresponding quinol. All metabolites are inactive.
Elimination: Propofol is rapidly cleared from the body (total clearance approx. 2 l/min). Clearance occurs by metabolism, mainly in the liver, where it is blood flow dependent. Clearance is higher in paediatric patients compared with adults. About 88 % of an administered dose is excreted in the form of metabolites in urine. Only 0.3 % is excreted unchanged in urine.
Paediatric population: After a single dose of 3 mg/kg intravenously, propofol clearance/kg body weight increased with age as follows: Median clearance was considerably lower in neonates < 1 month old (n = 25) (20 ml/kg/min) compared to older children (n = 36, age range 4 months - 7 years). Additionally inter-individual variability was considerable in neonates (range 3.7 - 78 ml/kg/min). Due to this limited trial data that indicates a large variability, no dose recommendations can be given for this age group.
Median propofol clearance in older aged children after a single 3 mg/kg bolus was 37.5 ml/min/kg (4-24 months) (n = 8), 38.7 ml/min/kg (11- 43 months) (n = 6), 48 ml/min/kg (1 - 3 years)(n = 12), 28.2 ml/min/kg (4 - 7 years)(n = 10) as compared with 23.6 ml/min/kg in adults (n = 6).
Toxicology: Preclinical safety data: Preclinical data reveal no specific hazard for humans based on conventional studies on repeated dose toxicity or genotoxicity. Carcinogenicity studies have not been conducted.
Reproductive toxicity studies have shown effects related to pharmacodynamic properties of propofol only at high doses. Teratogenic effects have not been observed.
In local tolerance studies, intramuscular injection resulted in tissue damage around the injection site.

PROPOFOL-LIPURO EMULSION FOR INJECTION/INFUSION is a short-acting intravenous general anaesthetic indicated for: induction and maintenance of general anaesthesia in adults and children > 1 month; sedation of ventilated patients >16 years of age in the intensive care unit; sedation for diagnostic and surgical procedures, alone or in combination with local or regional anaesthesia in adults and children > 1 month.

General instructions: PROPOFOL-LIPURO EMULSION FOR INJECTION/INFUSION should 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-oxymeter) and facilities for maintenance of patent airways, artificial ventilation, and other resuscitation facilities should always be immediately available at all times. For sedation during surgical or diagnostic procedures PROPOFOL-LIPURO EMULSION FOR INJECTION/INFUSION should not be given by the same person that carries out the surgical or diagnostic procedure.
Propofol is contraindicated in patients of 16 years of age or younger for sedation for intensive care (see Contraindications). Safety and efficacy for these age groups have not been demonstrated.
Supplementary analgesic medicinal products are generally required in addition to PROPOFOL-LIPURO EMULSION FOR INJECTION/INFUSION.
Posology: PROPOFOL-LIPURO EMULSION FOR INJECTION/INFUSION is given intravenously. The dosage is adjusted individually according to the patient's response.
General anaesthesia in adults: Induction of general anaesthesia: For induction of anaesthesia PROPOFOL-LIPURO EMULSION FOR INJECTION/INFUSION should be titrated (20 - 40 mg of propofol every 10 seconds) against the patient's response until the clinical signs show the onset of anaesthesia. Most adult patients younger than 55 years are likely to require 1.5 to 2.5 mg of propofol/kg body weight.
Propofol-Lipuro 200 mg/20 mL ampoule: In older patients and in patients of ASA grades III and IV, especially those with impaired cardiac function, the dosage requirements will be less and the total dose of Propofol-Lipuro 10 mg/ml may be reduced to 1 mg/kg body weight or less. In these patients lower rates of administration should be applied (approximately 2 ml, corresponding to 20 mg, every 10 seconds).
Propofol-Lipuro 500 mg/50 mL vial: In patients over this age and in patients of ASA grades III and IV, especially those with impaired cardiac function, the dosage requirements will be less and the total dose of PROPOFOL-LIPURO EMULSION FOR INJECTION/INFUSION 500MG/50ML may be reduced to a minimum of 1 mg/kg body weight. In these patients lower rates of administration should be applied (approximately 2 ml, corresponding to 20 mg every 10 seconds).
Maintenance of general anaesthesia: Anaesthesia can be maintained by administering PROPOFOL-LIPURO EMULSION FOR INJECTION/INFUSION either by continuous infusion or by repeat bolus injections. If a technique involving repeat bolus injections is used, increments of 25 - 50 mg (2.5 - 5.0 ml PROPOFOL-LIPURO EMULSION FOR INJECTION/INFUSION) may be given according to clinical requirements. For maintenance of anaesthesia by continuous infusion the dosage requirements usually are in the range of 4 - 12 mg/kg body weight/h.
In elderly patients, in patients of poor general condition, in patients of ASA grades III and IV and in hypovolaemic patients the dosage may be reduced further depending on the severity of the patient's condition and on the performed anaesthetic technique.
General anaesthesia in children over 1 month: Induction of anaesthesia: For induction of anaesthesia PROPOFOL-LIPURO EMULSION FOR INJECTION/INFUSION should be slowly titrated against the patient's response until the clinical signs show the onset of anaesthesia. The dosage should be adjusted according to age and/or body weight.
Most patients over 8 years of age require approximately 2.5 mg/kg body weight of propofol 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 body weight).
Maintenance of general anaesthesia: Anaesthesia can be maintained by administering PROPOFOL-LIPURO EMULSION FOR INJECTION/INFUSION 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 Precautions).
Sedation of ventilated patients in the Intensive Care Unit: For sedation during intensive care it is advised that propofol should be administered by continuous infusion. The infusion rate should be determined by the desired depth of sedation. In most patients sufficient sedation can be obtained with a dosage of 0.3 - 4 mg/kg/h of propofol (see also Precautions).
Propofol is not indicated for sedation in intensive care of patients of 16 years of age or younger (see Contraindications).
Administration of propofol by Target Controlled Infusion (TCI) system is not advised for sedation in the intensive care unit.
Sedation for diagnostic and surgical procedures in adults: 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/kg body weight over 1 to 5 minutes for onset of sedation. Maintenance of sedation may be accomplished by titrating PROPOFOL-LIPURO EMULSION FOR INJECTION/INFUSION infusion to the desired level of sedation. Most patients will require 1.5 - 4.5 mg/kg body weight/h. The infusion may be supplemented by bolus administration of 10 - 20 mg (1 - 2 ml PROPOFOL-LIPURO EMULSION FOR INJECTION/INFUSION) if a rapid increase of the depth of sedation is required.
In patients older than 55 years and in patients of ASA grade III and IV lower doses of PROPOFOL-LIPURO EMULSION FOR INJECTION/INFUSION may be required and the rate of administration may need to be reduced.
Sedation for diagnostic and surgical procedures in children over 1 month: 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 body weight of propofol for onset of sedation. Maintenance of sedation may be accomplished by titrating PROPOFOL-LIPURO EMULSION FOR INJECTION/INFUSION as infusion to the desired level of sedation. Most patients require 1.5 - 9 mg/kg/h of propofol. The infusion may be supplemented by bolus administration of up to 1 mg/kg b.w. if a rapid increase of depth of sedation is required.
In ASA III and IV patients lower doses may be required.
Method and duration of administration: Method of administration: Intravenous use.
PROPOFOL-LIPURO EMULSION FOR INJECTION/INFUSION is administered intravenously by injection or continuous infusion either undiluted or diluted with 5 % w/v glucose solution or 0.9 % w/v sodium chloride solution (for Propofol-Lipuro 200 mg/20 mL ampoule and Propofol-Lipuro 500 mg/50 mL vial) as well as in a 0.18 % w/v sodium chloride and 4 % w/v glucose solution (for Propofol-Lipuro 200 mg/20 mL ampoule) (see also Special precautions for disposal and other handlings under Cautions for Usage).
Containers should be shaken before use.
Before use, the neck of the ampoule or the surface of the rubber stopper of the vial should be cleaned with medicinal alcohol (spray or swabs). After use, tapped containers must be discarded.
PROPOFOL-LIPURO EMULSION FOR INJECTION/INFUSION contains no antimicrobial preservatives and supports growth of microorganisms. Therefore, PROPOFOL-LIPURO EMULSION FOR INJECTION/INFUSION is to be drawn up aseptically into a sterile syringe or an infusion set immediately after opening the ampoule or breaking the vial seal. Administration must commence without delay. Asepsis must be maintained for both PROPOFOL-LIPURO EMULSION FOR INJECTION/INFUSION and the infusion equipment throughout the infusion period.
Any medicinal products or fluids added to a running PROPOFOL-LIPURO EMULSION FOR INJECTION/INFUSION infusion must be administered close to the cannula site. Propofol must not be administered via infusion sets with microbiological filters. If infusion sets with filters are to be used, these must be lipid-permeable.
The contents of one ampoule or one vial of PROPOFOL-LIPURO EMULSION FOR INJECTION/INFUSION and any syringe containing PROPOFOL-LIPURO EMULSION FOR INJECTION/INFUSION are for single use in one patient.
Infusion of undiluted PROPOFOL-LIPURO EMULSION FOR INJECTION/INFUSION: When administering PROPOFOL-LIPURO EMULSION FOR INJECTION/INFUSION by continuous infusion, it is recommended that burettes, drop counters, syringe pumps or volumetric infusion pumps, should always be used to control the infusion rates. As established for the parenteral administration of all kinds of fat emulsions, the duration of continuous infusion of PROPOFOL-LIPURO EMULSION FOR INJECTION/INFUSION from one infusion system must not exceed 12 hours. The infusion line and the reservoir of PROPOFOL-LIPURO EMULSION FOR INJECTION/INFUSION must be discarded and replaced after 12 hours at the latest. Any portion of PROPOFOL-LIPURO EMULSION FOR INJECTION/INFUSION remaining after the end of administration or after replacement of the infusion system must be discarded.
Infusion of diluted PROPOFOL-LIPURO EMULSION FOR INJECTION/INFUSION: For administering infusion of diluted PROPOFOL-LIPURO EMULSION FOR INJECTION/INFUSION, burettes, drop counters, syringe pumps, or volumetric infusion pumps should always be used to control infusion rates and to avoid the risk of accidentally uncontrolled infusion of large volumes of diluted PROPOFOL-LIPURO EMULSION FOR INJECTION/INFUSION.
The maximum dilution must not exceed 1 part of PROPOFOL-LIPURO EMULSION FOR INJECTION/INFUSION with 4 parts of 5 % w/v glucose solution or 0.9 % w/v sodium chloride solution (for Propofol-Lipuro 200 mg/20 mL ampoule and Propofol-Lipuro 500 mg/50 mL vial), or 0.18 % w/v sodium chloride and 4 % w/v glucose solution (for Propofol-Lipuro 200 mg/20 mL ampoule) (minimum concentration 2 mg propofol/ml). The mixture should be prepared aseptically immediately prior to administration and must be used within 6 hours of preparation.
In order to reduce pain on initial injection, PROPOFOL-LIPURO EMULSION FOR INJECTION/INFUSION may be mixed with preservative-free lidocaine injection 1 % (mix 20 parts of PROPOFOL-LIPURO EMULSION FOR INJECTION/INFUSION with up to 1 part of lidocaine injection 1 %).
Before giving the muscle relaxants atracurium or mivacurium subsequent to PROPOFOL-LIPURO EMULSION FOR INJECTION/INFUSION through the same intravenous line, it is recommended that the line be rinsed prior to administration.
Propofol may also be used by Target Controlled Infusion. Due to the different algorithms available on the market for dosage recommendations please refer to the instructions for use leaflet of the device manufacturer.
This medicinal product must not be mixed with other medicinal products except those mentioned in Special precautions for disposal and other handlings under Cautions for Usage.
Duration of administration: PROPOFOL-LIPURO EMULSION FOR INJECTION/INFUSION can be administered for a maximum period of 7 days.

Symptoms: Accidental overdose is likely to cause cardiorespiratory depression.
Treatment: Respiratory depression should be treated by artificial ventilation with oxygen. Cardiovascular depression may require lowering the patient's head and if severe, use of plasma expanders and pressor agents.

Propofol-Lipuro 200 mg/20 mL ampoule: Propofol-Lipuro 200 mg/20 mL must not be used in patients with known hypersensitivity to propofol, soya or peanut or to any of the excipients of the emulsion; in children younger than 1 month for induction and maintenance of anaesthesia; in patients of 16 years of age or younger for sedation in intensive care (see also Precautions).
Propofol-Lipuro 500 mg/50 mL vial: Hypersensitivity to the active substance or to any of the excipients listed in Description.
PROPOFOL-LIPURO EMULSION FOR INJECTION/INFUSION 500MG/50ML contains soya-bean oil and should not be used in patients who are hypersensitive to peanut or soya.
PROPOFOL-LIPURO EMULSION FOR INJECTION/INFUSION 500MG/50ML must not be used in patients of 16 years of age or younger for sedation for intensive care (see Precautions).

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 of a patent airway, artificial ventilation, oxygen enrichment and other resuscitative facilities should be readily available at all times. Propofol should not be administered by the person conducting the diagnostic or surgical procedure.
The abuse of and dependence on propofol, predominantly by health care professionals, have been reported. As with other general anaesthetics, the administration of propofol without airway care may result in fatal respiratory complications.
When propofol is administered for conscious sedation, for surgical and diagnostic procedures, patients should be continually monitored for early signs of hypotension, airway obstruction and oxygen desaturation.
As with other sedative agents, when propofol is used for sedation during operative procedures, involuntary patient movements may occur. During procedures requiring immobility these movements may be hazardous to the operative site.
An adequate period is needed prior to discharge of the patient to ensure full recovery after use of propofol. Very rarely the use of propofol may be associated with the development of a period of post-operative unconsciousness, which may be accompanied by an increase in muscle tone. This may or may not be preceded by a period of wakefulness. Although recovery is spontaneous, appropriate care of an unconscious patient should be administered.
Propofol induced impairment is not generally detectable beyond 12 hours. The effects of propofol, the procedure, concomitant medications, the age and the condition of the patient should be considered when advising patients on: The advisability of being accompanied on leaving the place of administration; The timing of recommencement of skilled or hazardous tasks such as driving; The use of other agents that may sedate (e.g. benzodiazepines, opiates, alcohol).
As with other intravenous anaesthetic agents, caution should be applied in patients with cardiac, respiratory, renal or hepatic impairment or in hypovolaemic or debilitated patients (see Dosage & Administration).
Propofol clearance is blood flow dependent, therefore, concomitant medication which reduces cardiac output will also reduce propofol clearance.
Propofol lacks vagolytic activity and has been associated with reports of bradycardia (occasionally profound) and also asystole. The intravenous administration of an anticholinergic agent before induction or during maintenance of anaesthesia should be considered, especially in situations where the vagal tone is likely to predominate or when propofol is used in conjunction with other agents likely to cause bradycardia.
When propofol is administered to an epileptic patient, there may be a risk of convulsion. Before anaesthesia of an epileptic patient, it should be checked that the patient has received the antiepileptic treatment.
Appropriate care should be applied in patients with disorders of fat metabolism and in other conditions where lipid emulsions must be used cautiously.
It is recommended that blood lipid levels should be monitored if propofol is administered to patients thought to be at particular risk of fat overload. Administration of propofol should be adjusted appropriately if the monitoring indicates that fat is being inadequately cleared from the body. If the patient is receiving other intravenous lipid concurrently, a reduction in quantity should be made in order to take account of the amount of lipid infused as part of the propofol formulation; 1.0 ml of PROPOFOL-LIPURO EMULSION FOR INJECTION/INFUSION contains 0.1 g of fat.
Advisory statements concerning Intensive Care Unit management: Propofol-Lipuro 200 mg/20 mL ampoule: The safety and efficacy of propofol for (background) sedation in children younger than 16 years of age have not been demonstrated. Although no causal relationship has been established, serious undesirable effects with (background) sedation in patients younger than 16 years of age (including cases with fatal outcome) have been reported during unlicensed use. In particular these effects concerned occurrence of metabolic acidosis, hyperlipidemia, rhabdomyolysis and/or cardiac failure. These effects were most frequently seen in children with respiratory tract infections who received dosages in excess of those advised in adults for sedation in intensive care units (ICU).
Reports have been received of combinations of the following: metabolic acidosis, rhabdomyolysis, hyperkalaemia, hepatomegaly, renal failure, hyperlipidaemia, cardiac arrhythmia, Brugada-type ECG (elevated ST-segment and coved T-wave) and rapidly progressive cardiac failure usually unresponsive to inotropic supportive treatment (in some cases with fatal outcome) in adults combinations of these events have been referred to as the Propofol infusion syndrome.
The following appear to be the major risk factors for the development of these events: decreased oxygen delivery to tissues; serious neurological injury and/or sepsis; high dosages of one or more of the following pharmacological agents - vasoconstrictors, steroids, inotropes and/or propofol (usually following extended dosing at dose rates greater than 4mg/kg/h).
Prescribers should be alert to these events and consider decreasing the propofol dosage or switching to an alternative sedative at the first sign of occurrence of symptoms. All sedative and therapeutic agents used in the intensive care unit (ICU), including propofol, should be titrated to maintain optimal oxygen delivery and haemodynamic parameters. Patients with raised intracranial pressure (ICP) should be given appropriate treatment to support the cerebral perfusion pressure during these treatment modifications. Treating physicians are reminded if possible not to exceed the dosage of 4 mg/kg/h.
Propofol-Lipuro 500 mg/50 mL vial: Use of propofol for ICU sedation has been associated with a constellation of metabolic disturbances and system organ failures that may result in death. Reports have been received of combinations of the following: Metabolic acidosis, Rhabdomyolysis, Hyperkalaemia, Hepatomegaly, Renal failure, Hyperlipidaemia, Cardiac arrhythmia, Brugada-type ECG (elevated ST-segment and coved T-wave) and rapidly progressive cardiac failure usually unresponsive to inotropic supportive treatment. Combinations of these events have been referred to as the Propofol infusion syndrome.
These events were mostly seen in patients with serious head injuries and children with respiratory tract infections who received dosages in excess of those advised in adults for sedation in the intensive care unit.
The following appear to be the major risk factors for the development of these events: decreased oxygen delivery to tissues; serious neurological injury and/or sepsis; high dosages of one or more of the following pharmacological agents - vasoconstrictors, steroids, inotropes and/or propofol (usually at dose rates greater than 4 mg/kg/h for more than 48 hours).
Prescribers should be alert to these events in patients with the above risk factors and promptly consider decreasing or stopping the propofol dosage when the above signs develop. All sedative and therapeutic agents used in the intensive care unit (ICU) should be titrated to maintain optimal oxygen delivery and haemodynamic parameters. Patients with raised intra-cranial pressure (ICP) should be given appropriate treatment to support the cerebral perfusion pressure during these treatment modifications. Treating physicians are reminded if possible not to exceed the dosage of 4 mg/kg/h.
Additional precautions: PROPOFOL-LIPURO EMULSION FOR INJECTION/INFUSION contains no antimicrobial preservatives and supports growth of micro-organisms.
When propofol is to be aspirated, it must be drawn aseptically into a sterile syringe or giving set immediately after opening the ampoule or breaking the vial seal. Administration must commence without delay. Asepsis must be maintained for both propofol and infusion equipment throughout the infusion period. Any infusion fluids added to the propofol line must be administered close to the cannula site. Propofol must not be administered via a microbiological filter. If infusion sets with filters are to be used, these must be lipid-permeable.
Propofol and any syringe containing propofol are for single use in an individual patient. In accordance with established guidelines for other lipid emulsions, a single infusion of propofol must not exceed 12 hours. At the end of the procedure or at 12 hours, whichever is the sooner, both the reservoir of propofol and the infusion line must be discarded and replaced as appropriate.
Propofol-Lipuro 500 mg/50 mL vial: Caution should be taken when treating patients with mitochondrial disease. These patients may be susceptible to exacerbations of their disorder when undergoing anaesthesia, surgery and ICU care. Maintenance of normothermia, provision of carbohydrates and good hydration are recommended for such patients. The early presentations of mitochondrial disease exacerbation and of the 'propofol infusion syndrome' may be similar.
Special warnings/precautions regarding excipients: This medicinal product contains less than 1 mmol (23 mg) sodium in 100 ml, i.e. essentially 'sodium free'.
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.
Propofol induced impairment is not generally detectable beyond 12 hours (please see Precautions).
Use in children: The use of propofol is not recommended in newborn infants as this patient population has not been fully investigated. Pharmacokinetic data (see Pharmacology: Pharmacokinetics under Actions) indicate that clearance is considerably reduced in neonates and has a very high inter-individual variability. Relative overdose could occur on administering doses recommended for older children and result in severe cardiovascular depression.
Propofol must not be used in patients of 16 years of age or younger for sedation for intensive care as the safety and efficacy of propofol for sedation in this age group have not been demonstrated (see Contraindications).

Pregnancy: The safety of propofol during pregnancy has not been established. Propofol should not be given to pregnant woman except when absolutely necessary. Propofol crosses the placenta and can cause neonatal depression. Propofol can, however, be used during an induced abortion.
Breast-feeding: Studies of breast-feeding mothers showed that small quantities of propofol are excreted in human milk. Women should therefore not breastfeed for 24 hours after administration of propofol. Milk produced during this period should be discarded.

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 of an anaesthetic/sedative agent, such as hypotension. The nature, severity and incidence of adverse events observed in patients receiving propofol may be related to the condition of the recipients and the operative or therapeutic procedures being undertaken.
Table of Adverse Drug Reactions: Propofol-Lipuro 200 mg/20 mL ampoule: See Table 1.

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Note: Patients are advised to inform their doctor or pharmacist if they experience any adverse reaction not described in the monograph.
Propofol-Lipuro 500 mg/50 mL vial: Undesirable effects are listed according to their frequencies as follows: Very common (≥ 1/10); Common (≥ 1/100 to < 1/10); Uncommon (≥ 1/1,000 to < 1/100); Rare (≥ 1/10,000 to < 1/1,000); Very rare (< 1/10,000); Not known (cannot be estimated from the available data). (See Table 2.)

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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 incompatibility has been encountered. Lower doses of propofol may be required where general anaesthesia or sedation is used as an adjunct to regional anaesthetic techniques.
Propofol-Lipuro 500 mg/50 mL vial: Profound hypotension has been reported following anaesthetic techniques induction with propofol in patients treated with rifampicin.
A need for lower propofol doses has been observed in patients taking valproate. When used concomitantly, a dose reduction of propofol may be considered.

Incompatibilities: This medicinal product must not be mixed with other products except those mentioned in Special precautions for disposal and other handlings.
Special precautions for disposal and other handlings: Any unused product or waste material should be disposed of in accordance with local requirements.
Containers should be shaken before use.
For single use only. Any portion of contents remaining after first use must be discarded, see Dosage & Administration.
If two layers can be seen after shaking, the medicinal product should not be used.
Propofol-Lipuro 200 mg/20 mL ampoule: Propofol-Lipuro 200 mg/20 mL should only be mixed with the following products: 5 % w/v glucose solution, 0.9 % w/v sodium chloride solution, or 0.18 % sodium chloride and 4 % w/v glucose solution, and preservative-free lidocaine injection 1 % (see Method and duration of administration and Infusion of diluted PROPOFOL-LIPURO EMULSION FOR INJECTION/INFUSION under Dosage & Administration).
Co-administration of Propofol-Lipuro 200 mg/20 mL together with 5 % w/v glucose solution or 0.9 % w/v sodium chloride solution, or 0.18 % w/v sodium chloride and 4 % w/v glucose solution via a Y-connector close to the injection site is possible.
Propofol-Lipuro 500 mg/50 mL vial: PROPOFOL-LIPURO EMULSION FOR INJECTION/INFUSION 500MG/50ML should only be mixed with the following products: glucose 50 mg/ml (5% w/v) solution for infusion, sodium chloride 9 mg/ml (0.9% w/v) solution for infusion, and preservative-free lidocaine 10 mg/ml (1%) solution for injection (see Method and duration of administration and Infusion of diluted PROPOFOL-LIPURO EMULSION FOR INJECTION/INFUSION under Dosage & Administration).
Co-administration of PROPOFOL-LIPURO EMULSION FOR INJECTION/INFUSION 500MG/50ML together with glucose 50 mg/ml (5% w/v) solution for infusion or sodium chloride 9 mg/ml (0.9% w/v) solution for infusion via a Y-connector close to the injection site is possible.

Do not store above 25 °C. Do not freeze.
Keep the ampoules and vials in the outer carton in order to protect from light.
Shelf Life: 2 years.
After first opening: To be used immediately.
After dilution according to directions: Administration of dilution must commence immediately after preparation.

Anaesthetics - Local & General

N01AX10 - propofol ; Belongs to the class of other general anesthetics.

P₁S₁S₃