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FRESENIUS PROPOFOL is a brand name for Propofol. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Propofol 1 % (10 mg/1 ml) Fresenius is a short-acting intravenous general anaesthetic for - induction and maintenance of general anaesthesia in adults and children >1 month - sedation for diagnostic and surgical procedures, alone or in combination with local or regional anaesthesia in adults and children >1 month -…
Verbatim from this product's MHRA label. Tap a section to expand.
Propofol Fresenius 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. 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 Propofol Fresenius should not be administered by the same person conducting the surgical or diagnostic procedure. The dose of Propofol Fresenius emulsion should be individualised based on the response of the patient and premedications used.
Supplementary analgesic agents are generally required in addition to Propofol Fresenius.
Posology General anaesthesia in adults Induction of anaesthesia:
For induction of anaesthesia Propofol Fresenius 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. 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 Propofol Fresenius may be reduced to a minimum of 1 mg propofol/kg bodyweight.
Lower rates of administration of Propofol 1 % (10 mg/1 ml) Fresenius should be used (approximately 2 ml (20 mg propofol) every 10 seconds).
Maintenance of anaesthesia:
Anaesthesia can be maintained by administering Propofol 1 % (10 mg/1 ml) Fresenius 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 Propofol Fresenius may be reduced further depending on the severity of the patient’s condition and on the performed anaesthetic technique.
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 System Organ Class Frequency Undesirable Effects Immune system disorders: Very rare (<1/10 000) Anaphylaxis – may include angioedema, bronchospasm, erythema and hypotension Metabolism and Nutritional disorder: Frequency not known (9) Metabolic acidosis (5), hyperkalaemia (5), hyperlipidaemia (5) Psychiatric disorders: Frequency not known (9) Euphoric mood, sexual disinhibition.
Drug abuse and drug dependence (8) Common (>1/100, <1/10) Headache during recovery phase Rare (>1/10 000, <1/1000) Epileptiform movements, including convulsions and opisthotonus during induction, maintenance and recovery. Vertigo, shivering and sensation of cold during recovery Very rare (<1/10 000) Postoperative unconsciousness Nervous system disorders: Frequency not known (9) Involuntary movements Cardiac disorders: Common (>1/100, <1/10) Bradycardia (1) and tachycardia during induction Very rare (<1/10 000) Pulmonary oedema Frequency not known (9) Cardiac arrhythmia (5), cardiac failure (5), (7) Vascular disorders: Common (>1/100, <1/10) Hypotension (2) Uncommon (>1/1000, <1/100) Thrombosis and phlebitis Respiratory, thoracic and mediastinal disorders: Common (>1/100, <1/10) Transient apnoea, coughing and singultus during induction Frequency not known (9) Respiratory depression (dose dependant) Gastrointestinal disorders: Common (>1/100, <1/10) Nausea and vomiting during recovery phase Very rare (<1/10 000) Pancreatitis Hepatobiliary disorders Frequency not known (9) Hepatomegaly (5) Hepatitis(11), acute hepatic failure(11) Musculoskeletal and connective tissue disorders: Frequency not known (9) Rhabdomyolysis (3), (5) Very rare (<1/10 000) Discolouration of urine following prolonged administration Renal and urinary disorders Frequency not known (9) Renal failure(5) Reproductive system and breast disorders Not known Priapism General disorders and administration site conditions: Very common (>1/10) Local pain on induction (4) Very rare (<1/10 000) Tissue necrosis (10) following accidental extravascular administration Frequency not known (9) Local pain, swelling, following accidental extravascular administration Investigations Frequency not known (9) Brugada type ECG (5), (6) Injury, poisoning and procedural complications: Very rare (<1/10 000) Postoperative fever (1) Serious bradycardias are rare.
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. 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.
) Delayed epileptiform attacks may occur even in non-epileptic patients, the delay period ranging from a few hours to several days. Special patient groups Cardiac, circulatory or pulmonary insufficiency and hypovolaemia 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.
1. Propofol Fresenius contains soya oil and should not be used in patients who are hypersensitive to peanut or soya. 4).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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5 - 5 ml Propofol 1 % (10 mg/1 ml) Fresenius) should be given according to clinical requirements. Rapid bolus administration (single or repeated) should not be used in the elderly as this may lead to cardiopulmonary depression.
General anaesthesia in children over 1 month of age Induction of anaesthesia:
For induction of anaesthesia Propofol Fresenius should be titrated slowly until clinical signs show the onset of anaesthesia. The dose should be adjusted according to age and/or bodyweight. 5 mg/kg bodyweight Propofol Fresenius for induction of anaesthesia.
5 - 4 mg/kg bodyweight).
Maintenance of general anaesthesia:
Anaesthesia can be maintained by administering Propofol Fresenius 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). Sedation for diagnostic and surgical procedures in adult patients To provide sedation during surgical and diagnostic procedures, doses and administration rates should be adjusted according to the clinical response.
5 - 1 mg propofol/kg bodyweight over 1 to 5 minutes for onset of sedation. Maintenance of sedation may be accomplished by titrating Propofol Fresenius infusion to the desired level of sedation. 5 mg propofol/kg bodyweight/h. The infusion may be supplemented by bolus administration of 10 - 20 mg propofol (1 - 2 ml Propofol 1 % (10 mg/1 ml) Fresenius) 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 Propofol Fresenius may be required and the rate of administration may need to be reduced. Sedation for diagnostic and surgical procedures 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 bodyweight propofol for onset of sedation. Maintenance of sedation may be accomplished by titrating Propofol Fresenius infusion to the desired level of sedation. 5 - 9 mg/kg/h propofol. 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. Sedation in patients over 16 years of age in the intensive care unit When used to provide sedation for ventilated patients under intensive care conditions, it is recommended that Propofol Fresenius should be given by continuous infusion.
The dose should be adjusted according to the depth of sedation required. 0 mg propofol/kg bodyweight/h. 4). Administration of propofol by a target controlled infusion (TCI) system is not advised for sedation in the intensive care unit (ICU).
Method of administration For intravenous use. Propofol 1 % (10 mg/1 ml) […]
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 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. (11) After both long- and short-term treatment and in patients without underlying risk factors.
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.
Propofol clearance is blood flow dependent, therefore, concomitant medication which reduces cardiac output will also reduce propofol clearance. Cardiac, circulatory or pulmonary insufficiency and hypovolaemia should be compensated before administration of propofol.
Propofol should not be administered in patients with advanced cardiac failure or other severe myocardial disease except with extreme caution and intensive monitoring. Due to a higher dosage in patients with severe overweight the risk of haemodynamic effects on the cardiovascular system should be taken into consideration.
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 vagal tone is likely to predominate or when propofol is used in conjunction with other agents likely to cause a bradycardia.
Epilepsy When propofol is administered to an epileptic patient, there may be a risk of convulsion. In epileptic patients delayed epileptiform attacks may occur, the delay period ranging from a few hours to several days. Before anaesthesia of an epileptic patient, it should be checked that the patient has received the antiepileptic treatment.
Although several studies have demonstrated efficacy in treating status epilepticus, administration of propofol in epileptic patients may also increase the risk of seizure. Use of propofol is not recommended with electroconvulsive therapy.
Patients with disorders of fat metabolism Appropriate care should be applied in patients with disorders of fat metabolism and in other conditions where lipid emulsions must be used cautiously. Patients with a high intracranial pressure Special care should be recognised in patients with a high intracranial pressure and a low mean arterial pressure as there is a risk of a significant decrease of the intracerebral perfusion pressure.
Paediatric population The use of propofol is not recommended in newborn infants as this patient population has not been fully investigated. 2 of the SmPC) 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. Fresenius Propoven 1% is not advised for general anaesthesia in children younger than 1 month of age.
Due to the limited data available, the use of target controlled infusion (TCI) in the paediatric population below 2 years of age cannot be recommended. 3). Advisory statements concerning Intensive Care Unit management Use of propofol emulsion infusions for ICU sedation has been associated with a constellation of metabolic derangements and organ system 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 […]