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PROPOFOL is a brand name for Propofol. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Propofol 20 mg/mL is a short-acting intravenous general anaesthetic for: • Induction and maintenance of general anaesthesia in adults and children >3 years. • Sedation for diagnostic and surgical procedures, alone or in combination with local or regional anaesthesia in adults and children >3 years. • Sedation of…
Verbatim from this product's MHRA label. Tap a section to expand.
5. Such use is restricted to induction and maintenance of anaesthesia in adults. The ‘Diprifusor’ TCI system is not recommended for use in ICU sedation or in children. Induction of General Anaesthesia Adults Propofol 20 mg/mL may be used to induce anaesthesia by infusion.
Administration of Propofol 20 mg/mL by bolus injection is not recommended. Propofol 20 mg/mL may be used to induce anaesthesia by infusion but only in those patients who will receive Propofol 20 mg/mL for maintenance of anaesthesia.
In unpremedicated and premedicated patients, it is recommended that Propofol 20 mg/mL should be titrated (approximately 2 ml [40 mg] every 10 seconds in an average healthy adult by infusion) against the response of the patient until the clinical signs show the onset of anaesthesia.
5 mg/kg of Propofol 20 mg/mL. 5 ml/min [20–50 mg/min]). Over this age, the requirement will generally be less. In patients of ASA Grades 3 and 4, lower rates of administration should be used (approximately 1 ml [20 mg] every 10 seconds).
Elderly In older people the dose requirement for induction of anaesthesia with Propofol 20 mg/mL is reduced. The reduction should take into account of the physical status and age of the patient. The reduced dose should be given at a slower rate and titrated against the response.
Paediatric population Propofol 20 mg/mL is not recommended for induction of anaesthesia in children less than 3 years of age. For induction of anaesthesia in children over 3 years of age, Propofol 20 mg/mL should be titrated slowly until clinical signs show the onset of anaesthesia.
The dose should be adjusted according to age and/or body weight. 5 mg/kg body weight of Propofol 2% for induction of anaesthesia. 5–4 mg/kg body weight). 4). Administration of Propofol 20 mg/mL by a ‘Diprifusor’ TCI system is not recommended for induction of general anaesthesia in children.
Maintenance of General Anaesthesia Anaesthesia can be maintained by administering Propofol 20 mg/mL by continuous infusion to prevent the clinical signs of light anaesthesia. Administration of Propofol 20 mg/mL by bolus injection is not recommended.
Recovery from anaesthesia is typically rapid and it is therefore important to maintain Propofol 20 mg/mL administration until the end of the procedure. Adults The required rate of administration varies considerably between patients, but rates in the region of 4–12 mg/kg/h usually maintain satisfactory anaesthesia.
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 anaesthetic/sedative agent, such as hypotension.
The nature, severity and incidence of adverse events observed in patients receiving Propofol 20 mg/mL may be related to the condition of the recipients and the operative or therapeutic procedures being undertaken.
The following definitions of frequencies are used:
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) and not known (cannot be estimated from the available data). Table of Adverse Drug Reactions System Organ Class Frequency Undesirable effects Immune system disorders Very rare Anaphylaxis - may include angioedema, bronchospasm, erythema and hypotension Metabolism and nutrition disorders Not known (9) Metabolic acidosis (5), hyperkalaemia (5), hyperlipidaemia (5) Psychiatric disorders Not known (9) Euphoric mood.
Drug abuse and drug dependence (8) Common Headache during recovery phase Rare Epileptiform movements, including convulsions and opisthotonus during induction, maintenance and recovery Very rare Postoperative unconsciousness Nervous system disorders Not known (9) Involuntary movements Common Bradycardia (1) Very rare Pulmonary oedema Cardiac disorders Not known (9) Cardiac arrhythmia (5), cardiac failure (5), (7) Common Hypotension (2) Vascular disorders Uncommon Thrombosis and phlebitis Common Transient apnoea during inductionRespiratory, thoracic and mediastinal disorders Not known (9) Respiratory depression (dose dependent) Common Nausea and vomiting during recovery phaseGastrointestinal disorders Very rare Pancreatitis Hepatobiliary disorders Not known (9) Hepatomegaly (5) Musculoskeletal and connective tissue disorders Not known (9) Rhabdomyolysis (3), (5) Very rare Discolouration of urine following prolonged administration Renal and urinary disorders Not known (9) Renal failure (5) Reproductive system and breast disorders Very rare Sexual disinhibition Not known Priapism Very common Local pain on induction (4) Very rare Tissue necrosis (10) following accidental extravascular administration General disorders and administration site conditions Not known (9) Local pain, swelling, following accidental extravascular administration Investigations Not known (9) Brugada type ECG (5), (6) Injury, poisoning and procedural complications Very rare Postoperative fever (1) Serious bradycardias are rare.
). 3 Contraindications). Administration of Propofol 20 mg/mL by Diprifusor TCI system is not advised for sedation in the intensive care unit. It is recommended that blood lipid levels be monitored should Propofol 20 mg/mL be administered to patients thought to be at particular risk of fat overload.
Administration of Propofol 20 mg/mL should be adjusted appropriately if the monitoring indicates that fat is being inadequately cleared from the body. 1 g of fat. If the duration of sedation is in excess of 3 days, lipids should be monitored in all patients.
Older people When Propofol 20 mg/mL is used for sedation of anaesthesia the rate of infusion should also be reduced. Patients of ASA grades 3 and 4 will require further reductions in dose and dose rate. Rapid bolus administration (single or repeated) should not be used in older people as this may lead to cardiorespiratory depression.
Paediatric population Propofol 20 mg/mL is contra-indicated for the sedation of ventilated children aged 16 years or younger receiving intensive care. Sedation for Surgical and Diagnostic Procedures Adults To provide sedation for surgical and diagnostic procedures, rates of administration should be individualised and titrated to clinical response.
5–1 mg/kg over 1–5 minutes for onset of sedation. 5 mg/kg/h. In addition to the infusion, bolus administration of 10–20 mg may be used if a rapid increase in the depth of sedation is required. In patients of ASA Grades 3 and 4 the rate of administration and dosage may need to be reduced.
Administration of Propofol 20 mg/mL by a ‘Diprifusor’ TCI system is not recommended for sedation for surgical and diagnostic procedures. Elderly When Propofol 20 mg/mL is used for sedation the rate of infusion or ‘target concentration’ should also be reduced.
Patients of ASA grades 3 and 4 will require further reductions in dose and dose rate. Rapid bolus administration (single or repeated) should not be used in older people as this may lead to cardiorespiratory depression. Paediatric population Propofol 20 mg/mL is not recommended for surgical and diagnostic procedures in children aged less than 3 years.
). Administration of Propofol 20 mg/mL by Diprifusor TCI system is not advised for sedation in the intensive care unit. It is recommended that blood lipid levels be monitored should Propofol 20 mg/mL be administered to patients thought to be at particular risk of fat overload.
Administration of Propofol 20 mg/mL should be adjusted appropriately if the monitoring indicates that fat is being inadequately cleared from the body. 1 g of fat. If the duration of sedation is in excess of 3 days, lipids should be monitored in all patients.
Older people When Propofol 20 mg/mL is used for sedation of anaesthesia the rate of infusion should also be reduced. Patients of ASA grades 3 and 4 will require further reductions in dose and dose rate. Rapid bolus administration (single or repeated) should not be used in older people as this may lead to cardiorespiratory depression.
Paediatric population Propofol 20 mg/mL is contra-indicated for the sedation of ventilated children aged 16 years or younger receiving intensive care. Sedation for Surgical and Diagnostic Procedures Adults To provide sedation for surgical and diagnostic procedures, rates of administration should be individualised and titrated to clinical response.
5–1 mg/kg over 1–5 minutes for onset of sedation. 5 mg/kg/h. In addition to the infusion, bolus administration of 10–20 mg may be used if a rapid increase in the depth of sedation is required. In patients of ASA Grades 3 and 4 the rate of administration and dosage may need to be reduced.
Administration of Propofol 20 mg/mL by a ‘Diprifusor’ TCI system is not recommended for sedation for surgical and diagnostic procedures. Elderly When Propofol 20 mg/mL is used for sedation the rate of infusion or ‘target concentration’ should also be reduced.
Patients of ASA grades 3 and 4 will require further reductions in dose and dose rate. Rapid bolus administration (single or repeated) should not be used in older people as this may lead to cardiorespiratory depression. Paediatric population Propofol 20 mg/mL is not recommended for surgical and diagnostic procedures in children aged less than 3 years.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Elderly When Propofol 20 mg/mL is used for maintenance of anaesthesia the rate of infusion or ‘target concentration’ should also be reduced. Patients of ASA grades 3 and 4 will require further reductions in dose and dose rate. Rapid bolus administration (single or repeated) should not be used in older people as this may lead to cardiorespiratory depression.
Paediatric population Propofol 20 mg/mL is not recommended for maintenance of anaesthesia in children less than 3 years of age. Anaesthesia can be maintained in children over 3 years of age by administering Propofol 20 mg/mL by infusion 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, dose requirements may be higher. 4). Administration of Propofol 20 mg/mL by a 'Diprifusor' TCI System is not recommended for maintenance of general anaesthesia in children.
Sedation During Intensive Care Adults For sedation during intensive care it is advised that Propofol 20 mg/mL should be administered by continuous infusion. The infusion rate should be determined by the desired depth of sedation. 3-4 mg/kg/h of Propofol 20 mg/mL (See
There have been isolated reports of progression to asystole. (2) Occasionally, hypotension may require use of intravenous fluids and reduction of the administration rate of Propofol. (3) Very rare reports of rhabdomyolysis have been received where propofol has been given at doses greater than 4 mg/kg/hr for ICU sedation.
(4) May be minimised by using the larger veins of the forearm and antecubital fossa. With Propofol local pain can also be minimised by the co-administration of lidocaine. 4 (6) Brugada type ECG: elevated ST-segment and coved T-wave in ECG.
(7) Rapidly progressive cardiac failure (in some cases with fatal outcome) in adults. The cardiac failure in such cases was usually unresponsive to inotropic supportive treatment. (8) Abuse of and dependence on propofol, predominantly by health care professionals.
(9) Not known as it cannot be estimated from the available clinical trial data. (10) Necrosis has been reported where tissue viability has been impaired. Dystonia/dyskinesia have been reported. Local The local pain which may occur during the induction phase can be minimised by the use of the larger veins of the forearm and antecubital fossa.
Thrombosis and phlebitis are rare. Accidental clinical extravasation and animal studies showed minimal tissue reaction. Intraarterial injection in animals did not induce local tissue effects. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
In children over 3 years of age, 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 2% for onset of sedation.
Maintenance of sedation may be accomplished by titrating Propofol 20 mg/mL infusion to the desired level of sedation. 5–9 mg/kg/h Propofol 20 mg/mL. In ASA 3 and 4 patients lower doses may be required. Method of administration Propofol 20 mg/mL has no analgesic properties and therefore supplementary analgesic agents are generally required in addition to Propofol.
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 20mg/mL may be required where general anaesthesia is used as an adjunct to regional anaesthetic techniques. Profound hypotension has been reported following anaesthetic induction with propofol in patients treated with rifampicin.
Propofol 20 mg/mL should not be diluted. Propofol 20 mg/mL can be used for infusion undiluted from glass containers, plastic syringes or Propofol 20 mg/mL pre- filled syringes. When Propofol is used to maintain anaesthesia, it is recommended that equipment such as syringe pumps or volumetric infusion pumps should always be used to control infusion rates.
P. P. P. The glass pre-filled syringe (PFS) has a lower frictional resistance than plastic disposable syringes and operates more easily. Therefore, if Propofol is administered using a hand held pre-filled syringe, the line between the syringe and the patient must not be left open if unattended.
When the pre-filled syringe presentation is used in a syringe pump appropriate compatibility should be ensured. In particular, the pump should be designed to prevent syphoning and should have an occlusion alarm set no greater than 1000 mm Hg.
If using a programmable or equivalent pump that offers options for use of different syringes then choose only the ‘B-D’ 50/60 ml ‘PLASTIPAK’ setting when using the Propofol 20 mg/mL pre-filled syringe. Target Controlled Infusion - Administration of Propofol 20 mg/mL by a ‘Diprifusor’ TCI System in Adults Administration of Propofol 20 mg/mL by a ‘Diprifusor’ TCI 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, or in children. Propofol may be administered by TCI only with a ‘Diprifusor’ TCI system incorporating ‘Diprifusor’ TCI software. Such systems will operate only on recognition of electronically tagged pre-filled syringes containing Propofol 20 mg/mL Injection.
The ‘Diprifusor’ TCI system will automatically adjust the infusion rate for the concentration […]
In children over 3 years of age, 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 2% for onset of sedation.
Maintenance of sedation may be accomplished by titrating Propofol 20 mg/mL infusion to the desired level of sedation. 5–9 mg/kg/h Propofol 20 mg/mL. In ASA 3 and 4 patients lower doses may be required. Method of administration Propofol 20 mg/mL has no analgesic properties and therefore supplementary analgesic agents are generally required in addition to Propofol.
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 20mg/mL may be required where general anaesthesia is used as an adjunct to regional anaesthetic techniques. Profound hypotension has been reported following anaesthetic induction with propofol in patients treated with rifampicin.
Propofol 20 mg/mL should not be diluted. Propofol 20 mg/mL can be used for infusion undiluted from glass containers, plastic syringes or Propofol 20 mg/mL pre- filled syringes. When Propofol is used to maintain anaesthesia, it is recommended that equipment such as syringe pumps or volumetric infusion pumps should always be used to control infusion rates.
P. P. P. The glass pre-filled syringe (PFS) has a lower frictional resistance than plastic disposable syringes and operates more easily. Therefore, if Propofol is administered using a hand held pre-filled syringe, the line between the syringe and the patient must not be left open if unattended.
When the pre-filled syringe presentation is used in a syringe pump appropriate compatibility should be ensured. In particular, the pump should be designed to prevent syphoning and should have an occlusion alarm set no greater than 1000 mm Hg.
If using a programmable or equivalent pump that offers options for use of different syringes then choose only the ‘B-D’ 50/60 ml ‘PLASTIPAK’ setting when using the Propofol 20 mg/mL pre-filled syringe. Target Controlled Infusion - Administration of Propofol 20 mg/mL by a ‘Diprifusor’ TCI System in Adults Administration of Propofol 20 mg/mL by a ‘Diprifusor’ TCI 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, or in children. Propofol may be administered by TCI only with a ‘Diprifusor’ TCI system incorporating ‘Diprifusor’ TCI software. Such systems will operate only on recognition of electronically tagged pre-filled syringes containing Propofol 20 mg/mL Injection.
The ‘Diprifusor’ TCI system will automatically adjust the infusion rate for the concentration of Propofol recognised. Users must be familiar with the infusion pump users' manual, and with the administration of Propofol 20 mg/mL by […]