Anesticap

Each mL contains: Propofol 10 mg.
Also contains Soya Oil, Medium-chain Triglycerides, Egg Lecithin, Glycerol, Oleic Acid, Sodium Hydroxide, Water for Injection.

Pharmacology: Propofol is a short-acting general anesthetic agent with a rapid onset of action of approximately 30 seconds.
The duration of anesthesia depending on the metabolism and elimination is 4 to 6 minutes. During monitored anesthesia care sedation, attention must be given to the cardiorespiratory effect of Propofol. Hypotension, oxyhemoglobin desaturation, apnea, airway obstruction and/or oxygen desaturation can occur following a rapid bolus or rapid increases of Propofol. Propofol lack vagolytic activity and has been associated with reports of bradycardia and asystole.

ANESTICAP 1% MCT/LCT is a short-acting intravenous general anesthetic agent for: Induction and maintenance of general anesthesia.
Sedation of artificially ventilated patients in the Intensive Care Unit (ICU).

ANESTICAP 1% MCT/LCT must only be given in hospitals or adequately equipped therapy units by physicians trained in anesthesia or in the care of patients in intensive care.
Circulatory and respiratory functions should be constantly monitored (e.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 ANESTICAP 1% MCT/LCT should not be administered by the same person conducting the surgical or diagnostic procedure.
The dose of ANESTICAP 1% MCT/LCT emulsion should be individualized based on the response of the patient and premedications used.
Supplementary analgesic agents are generally required in addition to ANESTICAP 1% MCT/LCT.
Adults: General anesthesia: Induction of anesthesia: For induction of anesthesia ANESTICAP 1% MCT/LCT should be titrated (approximately 20 - 40 mg Propofol every 10 seconds) against the response of the patient until clinical signs show the onset of anesthesia.
Most adult patients aged less than 55 years are likely to require 40 mg every 10 seconds until induction onset (2 to 2.5 mg Propofol/kg body weight).
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 ANESTICAP 1% MCT/LCT may be reduced to a minimum of 1 mg Propofol/kg body weight. Lower rates of administration of ANESTICAP 1% MCT/LCT should be used approximately 2 mL (20 mg Propofol) every 10 seconds.
Maintenance of anesthesia: Anesthesia can be maintained by administering ANESTICAP 1% MCT/LCT either by continuous infusion or repeat bolus injections.
For maintenance of anesthesia generally doses of 4 to 12 mg Propofol/kg body weight/hour should be given. A reduced maintenance dose of approximately 4 mg Propofol/kg body weight/hour 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 ANESTICAP 1% MCT/LCT may be reduced further depending on the severity of the patient's condition and on the performed anesthetic technique.
The recommended reduction of the dosage of ANESTICAP 1% MCT/LCT is 3 to 6 mg Propofol/kg body weight/hour.
For maintenance of anesthesia using repeat bolus injections dose increments of 25 to 50 mg Propofol (= 2.5 - 5 mL ANESTICAP 1% MCT/LCT) should be given according to clinical requirements.
Sedation during intensive care: When used to provide sedation for ventilated patients under intensive care conditions, it is recommended that ANESTICAP 1% MCT/LCT should be given by continuous infusion. The dose should be adjusted according to the depth of sedation required. Usually satisfactory sedation is achieved with administration rates in the range of 0.3 to 4.0 mg Propofol/kg body weight/hour. Rates of infusion greater than 4.0 mg Propofol/kg body weight/hour are not recommended (see PRECAUTIONS).
Children over 3 years of age: General anesthesia: Due to lack of experience, ANESTICAP 1% MCT/LCT must not be used in children under 3 years of age.
Induction of anesthesia: When used to induce anesthesia, it is recommended that ANESTICAP 1% MCT/LCT should be titrated slowly until the clinical signs show the onset of anesthesia.
The dose should be adjusted for age and/or body weight. Children over 8 years of age are likely to require approximately 2.5 mg Propofol/kg body weight for induction of anesthesia. Under this age the dose requirement may be higher.
No experience is available in children of ASA grades III and IV.
Maintenance of anesthesia: For maintenance of anesthesia using continuous infusion doses of 9 to 15 mg Propofol/kg body weight/hour should be given.
Sedation during intensive care: Propofol must not be used for sedation in intensive care of patients of 16 years of age or younger (see CONTRAINDICATIONS).
If the patient is receiving other intravenous lipids concurrently, the amount of fat infused as part of the ANESTICAP 1% MCT/LCT formulation should be taken into account: 1.0 mL ANESTICAP 1% MCT/LCT contains 0.1 g of fat.
Method of Administration: The administration of the emulsion must be commence without delay after opening the ampoule. Aseptic must be maintained for both ANESTICAP 1% MCT/LCT and infusion equipment throughout the infusion period. Co-administration of other drugs or fluids added to the ANESTICAP 1% MCT/LCT infusion line must occur close to the cannula site. ANESTICAP 1% MCT/LCT must not be administered via a microbiological filter.

Overdose is likely to cause cardiovascular and respiratory depression. Respiratory depression is treated by artificial ventilation with oxygen. Cardiovascular depression may require lowering the patient's head and administering plasma volume substitutes and vasopressive agents.

In patients with a known hypersensitivity to Propofol or to any of the excipients of the emulsion.
In patients who are allergic to soya or peanut.
Must not be used for general anesthesia in children less than 3 years of age and for sedation of children less than 16 years of age in the Intensive Care Unit.
Must not be used during pregnancy, breast feeding and obstetric including cesarean section deliveries (except abortion).

In patients with cardiac, respiratory, renal or hepatic impairment or in elderly, debilitated, hypovolaemic or epileptic patients or patients with disorders of consciousness ANESTICAP 1% MCT/LCT should be administered with caution and a reduced administration rate (see DOSAGE & ADMINISTRATION).
Cardiac, circulatory or pulmonary insufficiency and hypovolaemia should be compensated before administration of ANESTICAP 1% MCT/LCT.
Before anesthesia of an epileptic patient, it should be checked that the patient has received the anti-epileptic treatment. Administration of Propofol in epileptic patients may also increase the risk of seizure.
ANESTICAP 1% MCT/LCT should not be administered in patients with advanced cardiac failure or other severe myocardial disease except with extreme caution and intensive monitoring.
The intravenous administration of an anticholinergic agent before induction, or during maintenance of anesthesia should be considered, especially in situations where vagal tone is likely to predominate, or when ANESTICAP 1% MCT/LCT is used in conjunction with other agents likely to cause a bradycardia.
Use is not recommended with electroconvulsive therapy.
Special care should be applied in patients with disorders of fat metabolism and in other conditions where lipid emulsions must be used with caution. If patients receive parenteral nutrition, it is necessary to take account of the amount of lipid infusion as part of the ANESTICAP 1% MCT/LCT formulation: 1.0 mL ANESTICAP 1% MCT/LCT contains 0.1 g of fat.
Lipids should be monitored in the Intensive Care Unit treatment after 3 days.
Due to a higher dosage in patients with severe overweight the risk of haemodynamic effects on the cardiovascular system should be taken into consideration.
Special care should be recognized 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.
To reduce pain on the injection site during induction of anesthesia with ANESTICAP 1% MCT/LCT, lidocain can be injected prior to the Propofol emulsion.
Dilutions with lidocain solution must not be used in patients with hereditary acute porphyria.
For sedation in adult patients, ANESTICAP 1% MCT/LCT must be given only by these physicians trained in anesthesia or intensive care.
ANESTICAP 1% MCT/LCT should not be administered by the persons conducting the diagnostic or surgical procedure.
ANESTICAP 1% MCT/LCT is not recommended for use in pediatric patients for ICU (Intensive Care Unit) sedation.
Although no causal relationship has been established, use of Propofol for sedation in children has led to serious and sometimes fatal adverse events. These events observed from spontaneous reports of unlicensed use were seen most often in children with respiratory tract infections given doses in excess of those recommended for adults.
Aseptic must be maintained for both ANESTICAP 1% MCT/LCT and infusion equipment throughout the infusion period. Co-administration of other drugs or fluids added to the ANESTICAP 1% MCT/LCT infusion line must occur close to the cannula site.
ANESTICAP 1% MCT/LCT must not be administered via a microbiological filter.
ANESTICAP 1% MCT/LCT and any infusion equipment containing ANESTICAP 1% MCT/LCT are for single administration in an individual patient.
Effects on driving ability and use machines: After administration of ANESTICAP 1% MCT/LCT, the patient should be kept under observation for an appropriate period of time. The patient should be instructed not to drive, operate machinery, or work in potentially hazardous situations. The patient should not be allowed to go home unaccompanied, and should be instructed to avoid consumption of alcohol.
Use in Pregnancy and Lactation: ANESTICAP 1% MCT/LCT must not be used during pregnancy, breast feeding and obstetrics (except abortion).

ANESTICAP 1% MCT/LCT must not be used during pregnancy, breast feeding and obstetrics (except abortion).

Commonly observed side effects of Propofol are hypotension, transient apnea and respiratory depression. Occasionally, hypotension requires a lowering of the administration rate of ANESTICAP 1% MCT/LCT and/or fluid replacement therapy, if necessary vasoconstrictive drugs. These effects depend on the Propofol dose administered but also on the type of premedication and other concomitant medication. Specifically, the following side effects have been observed: Immune system disorders: Rare: Clinical features of anaphylaxis, which may include Quincke's oedema, bronchospasm, erythema and hypotension.
Psychiatric disorders: Rare: Euphoria and sexual disinhibition during the recovery period.
Nervous system disorders: Common: During induction of anesthesia spontaneous movements and myocloni, minimal excitation.
Rare: Headache, vertigo, shivering and sensations of cold during the recovery period. Epileptiform movements including convulsions and opisthotonus.
Very rare: Delayed epileptiform attacks, the delay period ranging from a few hours to several days. Risk of convulsions in epileptic patients after administration of Propofol.
Rare: Cases of postoperative unconsciousness (see PRECAUTIONS), post operative fever and discoloration of urine following prolonged administration of Propofol.
Cardiac disorders/vascular disorders: Common: During induction of anesthesia, hypotension, bradycardia, tachycardia, hot flushes.
Uncommon: Marked hypotension. This may require a lowering of the administration rate of ANESTICAP 1% MCT/LCT and/or fluid replacement therapy, if necessary vasoconstrictive medicinal products. Account should be taken of the possibility of a severe drop in blood pressure in patients with impaired coronary or cerebral perfusion or those with hypovolaemia.
Bradycardia during general anesthesia with progressive severity (asystole). The intravenous administration of an anticholinergic medicinal product prior to induction or during maintenance of anesthesia should be considered (see PRECAUTIONS).
Rare: Arrhythmia during the recovery period. Thrombosis and phlebitis.
Changes in cardiovascular parameters may be important in patients with impaired myocardial oxygen delivery capacity, cerebral circulatory disturbances and hypovolaemia. The risk of relative vagal overactivity may be increased because ANESTICAP 1% MCT/LCT lacks vagolytic activity. It 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 anesthesia should be considered, especially in situation where vagal tone is likely to predominate or when ANESTICAP 1% MCT/LCT is used in conjunction with other agents likely to cause a bradycardia.
Respiratory, thoracic and mediastinal disorders: Common: During induction of anesthesia hyperventilation, transient apnea, coughing, singultus.
Uncommon: Coughing during maintenance of anesthesia.
Rare: Coughing during the recovery period.
Very rare: Pulmonary oedema.
Gastrointestinal disorders: Rare: Nausea or vomiting during the recovery period. Very rare: Pancreatitis has been reported after administration of Propofol.
Skin and subcutaneous tissue disorders: Very rare: Severe tissue responses after accidental paravenous application.
Renal and urinary disorders: Rare: Cases of discoloration of urine following prolonged administration of Propofol.
General disorders and administration site conditions: Very common: Local pain occurring during the initial injection. Prophylaxis or treatment see as follows.
The local pain which may occur during the initial injection of ANESTICAP 1% MCT/LCT can be minimized by the co-administration of lidocain (see INCOMPATIBILITIES UNDER CAUTIONS FOR USAGE) and by injection or infusion into the larger veins of the forearm and antecubital fossa. Upon co-administration of lidocain the following undesirable effects may occur rarely: Giddiness, vomiting, drowsiness, convulsions, bradycardia, cardiac arrhythmia and shock.
Rare: Cases of post-operative fever.
Very rare: There have been reports of isolated cases of severe undesirable effects presenting as a complex of symptoms including: Rhabdomyolysis, metabolic acidosis, hypercalaemia, and cardiac failure, sometimes with fatal outcome. Most of these effects have been observed in patients in intensive care with doses exceeding 4 mg/kg body weight/hour. For more detail, see PRECAUTIONS.

ANESTICAP 1% MCT/LCT can be used in combination with other medicinal products for anesthesia (pre-medications, volatile anesthetics, analgesics, muscle relaxants, local anesthetics). Severe interactions with these medicinal products have been reported. Some of these centrally acting medicinal products may exhibit a circulatory and respiratory depressive effect, thus leading to increased effects when used together with ANESTICAP 1% MCT/LCT.
Lower doses may be required when general anesthesia is carried out in conjunction with regional anesthesia.
Concomitant use of benzodiazepines, parasympatholytic agents or inhalational anesthetics has been reported to prolong the anesthesia and to reduce the respiratory rate.
After additional premedication with opioids, the sedative effects of Propofol may be intensified and prolonged, and there may be a higher incidence and longer duration of apnea.
It should be taken into consideration that concomitant use of Propofol and medicinal products for pre-medication, inhalation agents, or analgesic agents may potentiate anesthesia and cardiovascular side effects.
Concomitant use of central nervous system depressants (e.g., alcohol, general anesthetics, narcotic analgesics) will result in intensification of their sedative effects. When ANESTICAP 1% MCT/LCT is combined with centrally depressant agents administered parenterally, severe respiratory and cardiovascular depression may occur.
After administration of fentanyl, the blood level of Propofol may be temporarily increased with an increase in the rate of apnea.
Bradycardia and cardiac arrest may occur after treatment with suxamethonium or neostigmin.
Leucoencephalopathy has been reported with administration of lipid emulsions such as Propofol in patients receiving cyclosporine.
As some of these drugs are reported to act hypotension or to impair respiration, concomitant use of ANESTICAP 1% MCT/LCT may intensify these effects.

Incompatibilities: To reduce pain on the injection site, ANESTICAP 1% MCT/LCT may be mixed, immediately for use, with preservative free lidocaine injection 1% (20 parts of ANESTICAP 1% MCT/LCT with up to 1 part of 1% lidocain injection solution). Muscle relaxants like atracurium and mivacurium should only be administered after flush of the same infusion site used for ANESTICAP 1% MCT/LCT. ANESTICAP 1% MCT/LCT must not be diluted with other solutions for infusion or injection. Co-administration of a dextrose 5%, sodium chloride 0.9% or dextrose sodium chloride intravenous infusion solution with ANESTICAP 1% MCT/LCT is permitted via a Y-piece connector close to the injection site.
DO NOT ADMINISTER IF EMULSION IS NOT HOMOGENOUS AFTER SHAKING OR IF CONTAINER IS DAMAGED.

Store below 25°C, do not freeze.

Anaesthetics - Local & General

N01AX10 - propofol ; Belongs to the class of other general anesthetics.

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