Source: Health Products Regulatory Authority (ZA) Revision Year: 2021 Publisher: Biotech Laboratories (Pty) Ltd, Ground floor, Block K West, Central Park, 400 16<sup>th</sup> road, Randjespark, Midrand 1685, South Africa
MILSIA is indicated for:
Supplementary analgesic medicines are generally required in addition to MILSIA.
MILSIA has been used in association with spinal and epidural anaesthesia and with commonly used premedications, neuromuscular blocking medicines, inhalation and analgesic medicines; no pharmacological incompatibility has been encountered.
Dosage adjustment may be necessary when used together with the above medicines, particularly the narcotics (e.g. morphine, pethidine and fentanyl), combination of opioids and sedatives (e.g. benzodiazepines, barbiturates, droperidol, etc.), supplementary analgesic medicines (e.g. nitrous oxide or opioids) and the halogenated medicines (e.g. isoflurane, enflurane and halothane).
Where general anaesthesia with MILSIA is used simultaneously with a regional anaesthetic technique, lower doses of MILSIA may be required.
MILSIA may be used to induce anaesthesia by bolus injection or infusion.
Most adult patients aged less than 55 years are likely to require 1,5 to 2,5 mg/kg of MILSIA, (approximately 40 mg every 10 seconds in an average healthy adult) by slow bolus injection or infusion titrated against the response of the patient until clinical signs show onset of anaesthesia: The total dose required can be reduced by lower rates of administration (20–50 mg/minute). Over the age of 55 years the requirements will generally be less.
In patients of ASA Grades Ill and IV, lower rates of administration should be used (approximately 20 mg every 10 seconds).
Anaesthesia can be maintained by administering MILSIA either by continuous infusion or by repeat bolus injections to prevent the clinical signs of light anaesthesia.
The average rate of administration varies between patients, but rates in the region of 4 to 12 mg/kg/hour usually maintain satisfactory anaesthesia. Slightly higher rates of administration may be required for 10 to 20 minutes after induction of anaesthesia.
As a guide, increments of 25 mg to 50 mg may be used.
To provide sedation for ventilated adult patients undergoing intensive care, it is recommended that MILSIA be given by continuous infusion, for up to 72 hours. Adjust infusion rate according to the depth of sedation required. Rates of 0,3-4,0 mg/kg/hour should achieve satisfactory sedation. Rates above 4,0 mg/kg/hour are not recommended.
To provide sedation for surgical and diagnostic procedures, rates of administration should be individualised and titrated to clinical response.
Most patients will require 0,5 to 1 mg/kg over 1 to 5 minutes to initiate sedation. Maintenance of sedation may be accomplished by titrating MILSIA infusion to the desired level of sedation – most patients will require 1,5 to 4,5 mg/kg/hr. In addition to the infusion, bolus administration of 10 to 20 mg may be used if a rapid increase in the depth of sedation is required. In patients in ASA Grades Ill and IV, the rate of administration and dosage may need to be reduced.
In elderly patients the dose requirements for induction of anaesthesia with MILSIA is reduced. The reduction should take 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. Where MILSIA is used for maintenance of anaesthesia or sedation the rate of infusion or “target concentration” should also be reduced. Patients of ASA Grades III and IV, will require further reductions in dose and dose rate. Rapid bolus administration (single or repeated) should not be used in the elderly as this may lead to cardiorespiratory depression.
MILSIA is not recommended for use in children less than 3 years of age (see section 4.3).
When used to induce anaesthesia, it is recommended that MILSIA should be titrated slowly until the clinical signs show the onset of anaesthesia. The dose should be adjusted for age and/or body weight. Most children over 8 years of age are likely to require approximately 2,5 mg of MILSIA per kg body weight for induction of anaesthesia. Under this age the dose requirement may be higher. Lower dosages are recommended for young patients at increased risk (ASA grades Ill and IV).
Administer MILSIA by infusion to maintain the depth of anaesthesia required. The required rate of administration varies considerably between patients. 9 to 15 mg/kg/hour usually achieves satisfactory anaesthesia.
MILSIA is not recommended for sedation in children as safety and efficacy have not been demonstrated. Although no causal relationship has been established, serious side effects (including fatalities) have been observed from spontaneous reports of unlicensed use. These events were seen most often in children with respiratory tract infections, given doses in excess of those recommended for adults. Associated findings include metabolic acidosis, lipaemia, rhabdomyolysis, cardiac irregularities and renal failure.
MILSIA is not recommended for conscious sedation in children as safety and efficacy have not been demonstrated.
MILSIA 1% may be used to induce anaesthesia by intravenous injection or infusion and bolus injection.
MILSIA 2% may be used to induce anaesthesia by infusion only.
Administration of MILSIA 2% by bolus injection is not recommended.
When MILSIA is used undiluted to maintain anaesthesia, it is recommended that equipment such as drop counters, syringe pumps or volumetric infusion pumps should always be used to control infusion rates. MILSIA can be used for infusion undiluted in glass infusion bottles or from plastic syringes.
MILSIA can be diluted with 5% dextrose intravenous infusion only, in PVC infusion bags or glass infusion bottles.
It is recommended that, when using diluted MILSIA, the volume of 5% dextrose removed from the infusion bag during the dilution process is totally replaced in volume by MILSIA emulsion. 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.
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 volume or diluted MILSIA. 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 MILSIA in the burette.
MILSIA may be administered via a Y-piece close to the injection site, into intravenous infusion of dextrose 5%, sodium chloride 0,9% or dextrose 4% with sodium chloride 0,18%.
MILSIA may be premixed with alfentanil injection.
In order to reduce pain on initial injection, that part of the MILSIA used for induction may be mixed with lignocaine (lidocaine) injection in the ratio of 20 parts MILSIA with up to 1 part of 1% lignocaine (lidocaine) injection immediately prior to administration.
It is recommended that blood lipid levels be monitored routinely should MILSIA be administered to patients thought to be at particular risk of fat overload. Administration of MILSIA should be adjusted appropriately if the monitoring indicates that fat is being inadequately cleared from the body. If the patient is receiving other intravenous lipid concurrently, a reduction in quantity should be made in order to take account of the amount of lipid infused as part of the MILSIA formulation; 1,0 ml of MILSIA contains 0,1 g of fat. Patients with hypovolaemia should have fluid-volume deficits corrected prior to administration of MILSIA.
For incompatibilities, refer to section 6.2.
Containers should be shaken before use.
MILSIA should be inspected for particulate matter and discolouration before administration.
Do not use if there is evidence of separation of the phases of the emulsion.
MILSIA contains no anti-microbial preservatives and the vehicle supports growth of micro-organisms.
When MILSIA is to be aspirated it must be drawn aseptically into a sterile syringe or giving set immediately after breaking the vial seal.
Administration must commence without delay.
Asepsis must be maintained for both MILSIA and infusion equipment throughout the infusion period.
Any infusion fluids added to the MILSIA line must be administered close to the cannula site.
MILSIA must not be administered via a microbiological filter.
Any container or syringe containing MILSIA is for single use in a single patient only.
In accordance with established guidelines for other lipid emulsions a single infusion of MILSIA must not exceed 6 hours.
The syringe or giving set and any unused portion of MILSIA or solution containing MILSIA must be discarded at the end of the surgical procedure, or at 6 hours, whichever is the sooner, and replaced as appropriate.
Administration should commence promptly and must be completed within 12 hours after the vial has been spiked.
The tubing and any unused portion of MILSIA must be discarded after 12 hours.
If MILSIA is transferred to a syringe or other container prior to administration, the handling procedures for general anaesthesia (above) should be followed and the product should be discarded and administration lines changed after 6 hours.
See section 4.8.
Accidental overdosage is likely to cause cardiovascular and respiratory depression. Respiratory depression should be treated by artificial ventilation with oxygen. Cardiovascular depression would require lowering of the patient’s head, and, if severe, use of plasma expanders and pressor medicines. Treatment is symptomatic and supportive.
Unopened vials: 24 months.
After dilution: Dilutions should be prepared aseptically immediately before administration and must be used within 6 hours of preparation.
Store at or below 25°C. Do not freeze. Shake well before use.
Discard any unused portion after 6 hours.
MILSIA is presented in clear colourless glass vials (20 mL, 50 mL) or bottle (100 mL) with a grey bromobutyl rubber stopper crimped with a silver coloured aluminium cap and light blue polypropylene flip-off cap. The vials/bottles are placed in a carton with a package insert and patient information leaflet.
MILSIA is available in the following pack sizes:
MILSIA 1% 20 mL: Carton containing 5 vials of 20 mL of emulsion for injection or infusion.
MILSIA 1% 50 mL: Carton containing 1 vial of 50 mL emulsion for injection or infusion.
MILSIA 1% 100 mL: Carton containing 1 bottle of 100 mL emulsion for injection or infusion.
MILSIA 2%: Carton containing 1 vial of 50 mL emulsion for injection or infusion.
In use precautions:
Containers should be shaken before use.
Any portion of the contents remaining after use should be discarded.
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