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PROPOFOL BIOQ is a brand name for Propofol. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Propofol BioQ Pharma 10 mg/ml is a short-acting intravenous general anaesthetic for: - Induction and maintenance of general anaesthesia in adults and paediatric patients > 1 month of age - Sedation for diagnostic and surgical procedures, alone or in combination with local or regional anaesthesia in adults and…
Verbatim from this product's MHRA label. Tap a section to expand.
Propofol BioQ Pharma 10 mg/ml must only be administered 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 oximetry) and facilities for maintenance of a patient airways, artificial ventilation, and other resuscitation facilities should be immediately available at all times.
For sedation during surgical and diagnostic procedures Propofol BioQ Pharma 10 mg/ml should not be administered by the same person conducting the surgical or diagnostic procedure. Propofol BioQ Pharma 10 mg/ml has no analgesic properties and therefore supplementary analgesic agents are generally required in addition to Propofol BioQ Pharma 10 mg/ml.
Posology The dose of Propofol BioQ Pharma 10 mg/ml should be individually adapted according to the patient’s response. Rapid bolus administration (single or repeated) should not be used in the elderly as this may lead to cardiorespiratory depression.
General anaesthesia in adults Induction of anaesthesia For induction of anaesthesia Propofol BioQ Pharma 10 mg/ml must be titrated (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 body weight. In patients over 55 years and in patients of ASA (American Society of Anaesthesiologists) classification III and IV, especially in those with impaired cardiac function, the requirements will generally be less and the total dose of Propofol BioQ Pharma 10 mg/ml may be reduced to a minimum of 1 mg propofol/kg body weight.
These patients also need lower rates of administration (approximately 2 ml corresponding to 20 mg propofol every 10 seconds). Maintenance of anaesthesia Anaesthesia can be maintained by administering Propofol BioQ Pharma 10 mg/ml either by continuous infusion or repeat bolus injections (Propofol BioQ Pharma 10 mg/ml only).
Continuous infusion When using a continuous infusion for maintenance of anaesthesia generally doses of 4 to 12 mg propofol/kg body weight/hr should be given. 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 BioQ Pharma 10 mg/ml may be further reduced depending on the patient’s condition and on the applied anaesthetic method.
8. The infusion system should be rinsed before administration of muscle relaxants like atracurium and mivacurium when using the same infusion system for Propofol BioQ Pharma 10 mg/ml. Duration of administration Propofol BioQ Pharma 10 mg/ml can be administered for a maximum of 7 days.
1. - Hypersensitivity to soya or peanut. 4). 4 Special warnings and precautions for use 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 BioQ Pharma 10 mg/ml 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 BioQ Pharma 10 mg/ml without airway care may result in fatal respiratory complications.
When Propofol BioQ Pharma 10 mg/ml 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 BioQ Pharma 10 mg/ml 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 BioQ Pharma 10 mg/ml. 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.
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 BioQ Pharma 10 mg/ml 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 BioQ Pharma 10 mg/ml without airway care may result in fatal respiratory complications.
When Propofol BioQ Pharma 10 mg/ml 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 BioQ Pharma 10 mg/ml 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 BioQ Pharma 10 mg/ml. 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.
g. benzodiazepines, opiates, alcohol) During induction of anaesthesia, hypotension and transient apnoea may occur depending on the dose and use of premedications and other agents. 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. - Hypersensitivity to soya or peanut. 4).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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5 up to 5 ml Propofol BioQ Pharma 10 mg/ml) should be administered depending on the clinical requirements. Sedation of mechanically ventilated patients during intensive care Adults and adolescents (≥ 16 years of age) When used to provide sedation for mechanically ventilated patients under intensive care conditions, the administration of Propofol BioQ Pharma 10 mg/ml as continuous infusion is recommended.
The rate of administration has to be adapted to the level of sedation required. 4). Administering Propofol BioQ Pharma 10 mg/ml through a TCI-system for sedation in intensive care is not recommended. It is recommended that blood lipid levels be monitored should Propofol BioQ Pharma 10 mg/ml be administered to patients thought to be at particular risk of fat overload.
Administration of Propofol BioQ Pharma 10 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.
Sedation for diagnostic and surgical interventions in adult patients To provide sedation during surgical and diagnostic interventions, doses and administration rates need to be adapted to the clinical response. 0 mg propofol/kg body weight over 1 to 5 minutes for induction of sedation.
For maintenance of sedation the Propofol BioQ Pharma 10 mg/ml infusion should be titrated until the desired level of sedation is achieved. 5 mg propofol/kg body weight/hr will be required. The infusion may be supplemented by bolus injections of 10 to 20 mg (1 to 2 ml Propofol BioQ Pharma10 mg/ml) if a deeper level of sedation is rapidly required.
In patients older than 55 years and in patients of ASA classification III and IV the rate of administration and dosage may need to be reduced. 4). Induction of anaesthesia For induction of anaesthesia Propofol BioQ Pharma 10 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 propofol/kg body weight for induction of anaesthesia. 5-4 mg propofol/kg body weight). Maintenance of anaesthesia A satisfactory level of anaesthesia can generally be attained with a continuous infusion or by repeated bolus injection, using a dosage of 9 – 15 mg propofol /kg body weight/hr.
The dose needs to be individually adapted and special attention needs to be given to obtain adequate analgesia. In younger children, […]
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.
g. benzodiazepines, opiates, alcohol) During induction of anaesthesia, hypotension and transient apnoea may occur depending on the dose and use of premedications and other agents. 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.
Propofol clearance is blood flow dependent, therefore, concomitant medication that reduces cardiac output will also reduce propofol clearance. Cardiac, circulatory or pulmonary insufficiency and hypovolaemia should be compensated before administration of propofol.
In patients with severe cardiac impairment it is recommended that Propofol BioQ Pharma 10 mg/ml is given with great caution and under intensive monitoring. Due to the higher doses to be usually applied in patients with severe overweight, the increased risk of adverse haemodynamic effects 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 the vagal tone is likely to predominate or when Propofol BioQ Pharma 10 mg/ml is used in conjunction with other agents likely to cause bradycardia.
2). Epilepsy When Propofol BioQ Pharma 10 mg/ml 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.
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 a high intracranial pressure Special care should be taken in patients with high intracranial pressure and low arterial pressure as there is a risk of significant decrease of the intracerebral perfusion pressure. Patients with hereditary disorders Dilutions of Propofol BioQ Pharma 10 mg/ml with lidocaine solution must not be used in patients with hereditary predisposition to acute porphyria.
Paediatric population Administration of Propofol BioQ Pharma 10 mg/ml for anaesthesia in infants and children up to the age of 3 needs extra attention, although recent data shows that there are no clear safety differences in comparison to children older than 3 years.
The use of Propofol BioQ Pharma 10 mg/ml is not recommended for newborn infants younger than 1 month as this patient population has not been fully investigated. 2) indicate that clearance is considerably reduced in neonates with a very high inter-individual variability.
Relative overdose could occur administering doses recommended for older children resulting in severe cardiovascular depression. Propofol BioQ Pharma 10 mg/ml must not be used in patients of 16 years […]
Propofol clearance is blood flow dependent, therefore, concomitant medication that reduces cardiac output will also reduce propofol clearance. Cardiac, circulatory or pulmonary insufficiency and hypovolaemia should be compensated before administration of propofol.
In patients with severe cardiac impairment it is recommended that Propofol BioQ Pharma 10 mg/ml is given with great caution and under intensive monitoring. Due to the higher doses to be usually applied in patients with severe overweight, the increased risk of adverse haemodynamic effects 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 the vagal tone is likely to predominate or when Propofol BioQ Pharma 10 mg/ml is used in conjunction with other agents likely to cause bradycardia.
2). Epilepsy When Propofol BioQ Pharma 10 mg/ml 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.
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 a high intracranial pressure Special care should be taken in patients with high intracranial pressure and low arterial pressure as there is a risk of significant decrease of the intracerebral perfusion pressure. Patients with hereditary disorders Dilutions of Propofol BioQ Pharma 10 mg/ml with lidocaine solution must not be used in patients with hereditary predisposition to acute porphyria.
Paediatric population Administration of Propofol BioQ Pharma 10 mg/ml for anaesthesia in infants and children up to the age of 3 needs extra attention, although recent data shows that there are no clear safety differences in comparison to children older than 3 years.
The use of Propofol BioQ Pharma 10 mg/ml is not recommended for newborn infants younger than 1 month as this patient population has not been fully investigated. 2) indicate that clearance is considerably reduced in neonates with a very high inter-individual variability.
Relative overdose could occur administering doses recommended for older children resulting in severe cardiovascular depression. 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 […]