PROPOFOL

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 sedation for surgical and diagnostic procedures, or in children. Induction of General Anaesthesia Adults In unpremedicated and premedicated patients, it is recommended that Propofol 1% should be titrated (approximately 4 ml [40 mg] every 10 seconds in an average healthy adult by bolus injection or infusion) against the response of the patient until the clinical signs show the onset of anaesthesia.

5 mg/kg of Propofol 1%. The total dose required can be reduced by lower rates of administration (2– 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 2 ml [20 mg] every 10 seconds).

Elderly In older people the dose requirement for induction of anaesthesia with Propofol 1% 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 1% is not recommended for induction of anaesthesia in children aged less than 1 month. For induction of anaesthesia in children over 1 month of age, Propofol 1% 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 1% for induction of anaesthesia. 5– 4 mg/kg body weight). 4). Administration of Propofol 1% by a ‘Diprifusor’ TCI system is not recommended for induction of general anaesthesia in children.

Maintenance of General Anaesthesia Adults Anaesthesia can be maintained by administering Propofol 1% either by continuous infusion or by repeat bolus injections to prevent the clinical signs of light anaesthesia. Recovery from anaesthesia is typically rapid and it is therefore important to maintain Propofol 1% administration until the end of the procedure.

• Continuous Infusion The required rate of administration varies considerably between patients, but rates in the region of 4–12 mg/kg/h usually maintain satisfactory anaesthesia. 0 ml) may be given according to clinical need. Elderly When Propofol 1% 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 1% is not recommended for maintenance of anaesthesia in children aged less than 1 month.

Anaesthesia can be maintained in children over 1 month of age by administering Propofol 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. 4). Administration of Propofol 1% 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 1% 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 1% (See

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 1% 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 Very rare Anaphylaxis – may include angioedema, bronchospasm, erythema and hypotension Immune system disorders Not known Anaphylactic shock 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) Nervous system disorders Common Headache during recovery phase Rare Epileptiform movements, including convulsions and opisthotonus during induction, maintenance and recovery Very rare Postoperative unconsciousness Not known (9) Involuntary movements Cardiac disorders Common Bradycardia (1) Very rare Pulmonary oedema Not known (9) Cardiac arrhythmia (5), cardiac failure (5), (7) Vascular disorders Common Hypotension (2) Uncommon Thrombosis and phlebitis Common Transient apnoea during inductionRespiratory, thoracic and mediastinal disorders Not known (9) Respiratory depression (dose dependent) Gastrointestinal disorders Common Nausea and vomiting during recovery phase 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 Not known Sexual disinhibition 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.

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 1%. (3) Very rare reports of rhabdomyolysis have been received where Propofol 1% 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 1% 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 drug 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 of Propofol 1% anaesthesia can be minimised by the co-administration of lidocaine (see "Dosage and Administration") and 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. Intra-arterial 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.

). 3 Contraindications). Administration of Propofol 1% by Diprifusor TCI system is not advised for sedation in the intensive care unit. Propofol 1% may be diluted with 5% Dextrose (see "Dilution and Co-administration" table below). It is recommended that blood lipid levels be monitored should Propofol 1% be administered to patients thought to be at particular risk of fat overload.

Administration of Propofol 1% should be adjusted appropriately if the monitoring indicates that fat is being inadequately cleared from the body. 1g of fat. If the duration of sedation is in excess of 3 days, lipids should be monitored in all patients.

Elderly When Propofol 1% is used for sedation 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 1% is contraindicated 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 1% by a ‘Diprifusor’ TCI system is not recommended for sedation for surgical and diagnostic procedures. Elderly When Propofol 1% 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 1% is not recommended for surgical and diagnostic procedures in children aged less than 1 month.

In children over 1 month 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 1% for onset of sedation.

Maintenance of sedation may be accomplished by titrating Propofol 1% infusion to the desired level of sedation. 5–9 mg/kg/h Propofol 1%. The infusion may be supplemented by bolus administration of up to 1 mg/kg body weight if a rapid increase of depth of sedation is required.

In ASA 3 and 4 patients lower doses may be required. Method of administration Propofol 1% has no analgesic properties and therefore supplementary analgesic agents are generally required in addition to Propofol 1%. Propofol 1% can be used for infusion undiluted from glass containers, plastic syringes or Propofol 1% pre-filled syringes or diluted with 5% Dextrose (Intravenous Infusion BP) only, in PVC infusion bags or glass infusion bottles.

Dilutions, which must not exceed 1 in 5 (2 mg propofol per ml) should be prepared aseptically immediately before administration and must be used within 6 hours of preparation. It is recommended that, when using diluted Propofol 1%, the volume of 5% Dextrose removed from the infusion bag during the dilution process is totally replaced in volume by Propofol 1% emulsion.

(see "Dilution and Co-administration" table below). The dilution may be used with a variety of infusion control techniques, but a giving set used alone will not avoid the risk of accidental uncontrolled infusion of large volumes of diluted Propofol 1%.

A burette, drop counter or volumetric pump must be included in the infusion line. The risk of uncontrolled infusion must be taken into account when deciding the maximum amount of Propofol 1% in the burette. When Propofol 1% is used undiluted 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 1% 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 1% pre-filled syringe. Propofol 1% may be premixed with alfentanil injection containing 500 micrograms/ml alfentanil in the ratio of 20:1 to 50:1 v/v.

Mixtures should be prepared using sterile technique and used within 6 hours of preparation. In order to reduce pain on initial injection, Propofol 1% may be […]

). Administration of Propofol 1% by Diprifusor TCI system is not advised for sedation in the intensive care unit. Propofol 1% may be diluted with 5% Dextrose (see "Dilution and Co-administration" table below). It is recommended that blood lipid levels be monitored should Propofol 1% be administered to patients thought to be at particular risk of fat overload.

Administration of Propofol 1% should be adjusted appropriately if the monitoring indicates that fat is being inadequately cleared from the body. 1g of fat. If the duration of sedation is in excess of 3 days, lipids should be monitored in all patients.

Elderly When Propofol 1% is used for sedation 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 1% is contraindicated 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 1% by a ‘Diprifusor’ TCI system is not recommended for sedation for surgical and diagnostic procedures. Elderly When Propofol 1% 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 1% is not recommended for surgical and diagnostic procedures in children aged less than 1 month.

In children over 1 month 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 1% for onset of sedation.

Maintenance of sedation may be accomplished by titrating Propofol 1% infusion to the desired level of sedation. 5–9 mg/kg/h Propofol 1%. The infusion may be supplemented by bolus administration of up to 1 mg/kg body weight if a rapid increase of depth of sedation is required.

In ASA 3 and 4 patients lower doses may be required. Method of administration Propofol 1% has no analgesic properties and therefore supplementary analgesic agents are generally required in addition to Propofol 1%. Propofol 1% can be used for infusion undiluted from glass containers, plastic syringes or Propofol 1% pre-filled syringes or diluted with 5% Dextrose (Intravenous Infusion BP) only, in PVC infusion bags or glass infusion bottles.

Dilutions, which must not exceed 1 in 5 (2 mg propofol per ml) should be prepared aseptically immediately before administration and must be used within 6 hours of preparation. It is recommended that, when using diluted Propofol 1%, the volume of 5% Dextrose removed from the infusion bag during the dilution process is totally replaced in volume by Propofol 1% emulsion.

(see "Dilution and Co-administration" table below). The dilution may be used with a variety of infusion control techniques, but a giving set used alone will not avoid the risk of accidental uncontrolled infusion of large volumes of diluted Propofol 1%.

A burette, drop counter or volumetric pump must be included in the infusion line. The risk of uncontrolled infusion must be taken into account when deciding the maximum amount of Propofol 1% in the burette. When Propofol 1% is used undiluted 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 1% 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 1% pre-filled syringe. Propofol 1% may be premixed with alfentanil injection containing 500 micrograms/ml alfentanil in the ratio of 20:1 to 50:1 v/v.

Mixtures should be prepared using sterile technique and used within 6 hours of preparation. 5% or 1%; (see "Dilution and Co-administration" table below). Target Controlled […]