Propofol 1%/2% MCT Fresenius

/ Cure Medical & Technical Supply

General instructions
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. 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 be immediately available at all times. For sedation during surgical or diagnostic procedures should not be given by the same person that carries out the surgical or diagnostic procedure.
Posology
This medical product is given intravenously. The dosage is adjusted individually according to the patient’s response.
General anaesthesia in adults
Induction of anaesthesia:
Titrated against the patient’s response until the clinical signs show the onset of anaesthesia (20-40 mg of propofol every 10 seconds). Most adult patients younger than 55 years are likely to require 1.5 to 2.5 mg/kg body weight. 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 reduced to a minimum of 1 mg/kg. In these patients lower rates of administration should be applied (approximately 20 mg/2 ml, every 10 seconds).
Maintenance of anaesthesia:
Anaesthesia can be maintained by administering Propofol either by continuous infusion or by repeat bolus injections.
* Repeat bolus injections is used, increments of 25-50 mg (2.5-5 ml) may be given according to clinical requirements.
* Continuous infusion the dosage requirements usually are in the range of 4-2 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.
Rapid bolus administration (single or repeated) should not be used in older people as
this may lead to cardiorespiratory depression.
General anaesthesia in children over 1 month of age/ 3 years of age for 2%
Induction of anaesthesia:
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.
In younger children, especially between the age of 1 month and 3 years, dose requirements may be higher (2.5-4 mg/kg).
Maintenance of general anaesthesia:
Anaesthesia can be maintained by administering 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.
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.
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 1-5 minutes for onset of
sedation. Maintenance of sedation may be accomplished by titrating 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) 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 may be required and the rate of administration may need to be reduced.
Rapid bolus administration (single or repeated) should not be used in older people as
this may lead to cardiorespiratory depression.
Sedation for diagnostic and surgical procedures in children over 1 month of age/ 3
years of age for 2%
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 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. if a rapid increase of depth of sedation is required.
In ASA III and IV patients lower doses may be required.
Duration of administration
Administered for a maximum period of 7 days
See prescribing information for full details.

Propofol 1%
* 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
* Sedation of ventilated patients > 16 years of age in the intensive care unit
Propofol 2%
* 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 ventilated patients > 16 years of age in the intensive care unit

* Hypersensitivity to the active substance or to any of the excipients
* Should not be used in patients who are hypersensitive to peanut or soya.
* Must not be used in patients of 16 years of age or younger for sedation in intensive care.

General information:
* Patients should be constantly monitored and facilities for maintenance of a patient airway, artificial ventilation, oxygen enrichment and other resuscitative facilities should be readily available at all times.
* For conscious sedation, for surgical and diagnostic procedures, patients should be continually monitored for early signs of hypotension, airway obstruction and oxygen desaturation.
* 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 postoperative 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 clearance is blood flow dependent, therefore, concomitant medication that reduces cardiac output will also reduce clearance.
* During bolus administration for operative procedures, extreme caution should be exercised in patients with acute pulmonary.
* When Propofol is combined with centrally depressant drugs administered parenterally, severe respiratory and cardiovascular depression may occur. It is recommended administered Propofol following the analgesic and the dose should be carefully titrated to the patient’s response.
* During bolus administration for operative procedures, extreme caution should be exercised in patients with acute pulmonary insufficiency or respiratory depression.
* During induction of anaesthesia, hypotension and transient apnoea may occur depending on the dose and use of premedicants and other agents.
* Occasionally, hypotension may require use of intravenous fluids and reduction of the rate of administration during the period of anaesthetic maintenance.
* Use is not recommended with electroconvulsive treatment.
* Sexual disinhibition may occur during recovery.
Propofol Infusion Syndrome (PIS): A fatal combination of metabolic acidosis, rhabdomyolysis, hyperkalaemia, hepatomegaly, renal failure, hyperlipidaemia, and cardiac failure. Major risk factors: dosage > 4 mg/kg/h, sepsis, neurological injury, or prolonged use (> 48h).
Cardiovascular Risks:
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.
Use with extreme caution in patients with: cardiac, respiratory, renal or hepatic impairment or in hypovolaemic or debilitated patients.
Central nervous system depressants: e.g., alcohol, general anaesthetics, narcotic analgesics will result in accentuation of their sedative effects. Patients should be instructed to avoid alcohol before and for at least 8 hours after administration.
During bolus administration for operative procedures, extreme caution should be exercised in patients with acute pulmonary insufficiency or respiratory depression.
Fat Metabolism Disorders: Use cautiously in patients with lipid metabolism disorders as the product contains 0.1 g fat per 1 ml.
Mitochondrial Disease: Susceptible to exacerbations; ensure hydration and carbohydrate intake.
Neurological: Risk of convulsions in epileptics.
See prescribing information for full details.

Very common: Local pain on induction
Common: Headache during recovery phase, Bradycardia, Hypotension, Transient apnoea during induction, Nausea and vomiting during recovery phase.
See prescribing information for full details.

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 is used as an adjunct to regional anaesthetic techniques.
Profound hypotension has been reported following anaesthetic with propofol in patients treated with rifampicin.
The concurrent administration of other CNS depressants such as pre-medication drugs, inhalation agents, analgesic agents may add to the sedative, anaesthetic and cardiorespiratory depressant effects of Propofol.
A need for lower propofol doses has been observed in patients taking valproate.
A need for lower propofol doses has been observed in patients taking midazolam. The coadministration of propofol with midazolam is likely to result in enhanced sedation and respiratory depression.
Co-administration with dexmedetomidine is likely to lead to an enhancement of
effects. Propofol dose required for sedation may have to be reduced in the presence of dexmedetomidine.

Pregnancy: The safety of Propofol during pregnancy has not been established. Propofol should not be given to pregnant women except when absolutely
necessary.
Lactation: 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. Milk produced during this period should be discarded.
See prescribing information for full details.

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

Shelf life after dilution
The mixture should be prepared aseptically immediately prior to administration and must be administered within 6 hours after preparation.