Propofol-Novo, 10 mg/ml, emulsion for intravenous administration, 50 ml, 1 pc.

What is the drug Propofol?

Let's figure out what kind of medicine this is - Propofol. This is an ultra-short-acting sleeping pill, i.e. It works practically only while it is administered (or while it is present in the blood in sufficient concentration). Method of administration: intravenous.

The effect of Propofol includes 2 important components - hypnotic and amnesic. This means that under the influence of Propofol a person falls asleep and after waking up does not remember what happened during sleep. Propofol does not provide an analgesic effect, so it must be combined with analgesics.

The main active ingredient of Propofol is 2,6-diisopropylphenol. Its main advantage is that it has the same effectiveness as some other previously used drugs, but is safer, provides an easier recovery from anesthesia and fewer side effects.

The substance is insoluble in water, therefore it is used in the form of an aqueous emulsion of oils in which the active ingredient is dissolved (currently soybean oil). It appears as a white liquid resembling milk.

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What group of drugs does Propofol belong to?

Propofol is a drug whose purpose is to induce and maintain general anesthesia, as well as sedation during mechanical ventilation. Chemically, Propofol (more precisely, its main active ingredient diisopropylphenol) is a phenol molecule with two isopropyl groups attached to it. It is not included in the groups of barbiturates or opioids, it is not a narcotic drug, therefore it is not characterized by the severe side effects of drugs from these groups.

Read also[edit | edit code]

• Anesthesiology
• History of anesthesiology
• Anesthesia in the preoperative period
• Anesthesia during the intraoperative period Induction of anesthesia
• Maintenance of anesthesia

How does the drug affect the body?

The mechanism of action of Propofol has not yet been fully studied. Its main effect is associated with the fact that it enhances and prolongs the action of GABA (gamma-aminobutyric acid), an amino acid that plays the role of an inhibitory neurotransmitter in the central nervous system, responsible for calm, relaxation and sleep.

When administered, Propofol begins to act almost immediately - it instantly penetrates the brain and causes rapid onset of sleep. Next, a maintenance dose of the drug is administered through an intravenous catheter. An anesthesiologist, using special equipment, controls the depth of sleep, the dosage of incoming medication, the patient's breathing, blood oxygen saturation, blood pressure and heart rate. After completing the treatment procedures, the supply of Propofol is stopped, and the patient wakes up after 5-10 minutes as if from a normal sleep.

Pharmacological properties

Propofol is a pharmaceutical agent used for general anesthesia. The medication begins to “work” within half a minute, lasting a short time interval.

After the administration of the anesthetic, the pulse rate changes and the pressure decreases. During general anesthesia, hemodynamic parameters remain generally stable.

It is important to note that respiratory depression sometimes occurs after administration of the drug.

All side effects of the anesthetic are also typical for other similar drugs; specialists in a medical facility can easily control them.

Propofol leads to:

• Reduced intracranial pressure
• Decreased cerebral blood flow
• Reduced cerebral metabolism

The effect of the drug is very noticeable in people who have increased intracranial pressure.

Coming out of anesthesia, the person is conscious and absent:

• nausea and vomiting (due to the antiemetic effect of the anesthetic)
• Headache

How long does Propofol take to leave the body?

Propofol is eliminated through its breakdown in the liver with the formation of inert metabolites and further removal through the kidneys. Only 1-2% of propofol is excreted unchanged. The time it takes to remove half of the substance contained depends on the duration of its administration.

The fact is that the substance penetrates unevenly into different tissues. At the very beginning of the administration of the drug (so far it has penetrated only into tissues directly supplied with blood through large arteries), it takes from 1 to 8 minutes for its concentration to drop by half after stopping the supply.

If Propofol is administered within 8 hours, then it has time to penetrate all tissues of the body, therefore, when the supply is stopped, it begins to enter the blood from those tissues into which it penetrated slowly over all these hours, and therefore the same half-life is already increasing up to 40 minutes. The drug is completely eliminated from the body after a few hours.

Stability and storage

Store at temperatures between 4 and 25°C.

Avoid freezing. Keep away from light. Shake well before use. The original composition is used in ampoules and vials without preservatives and must be used within 6 hours. Use careful and aseptic technique to prevent microbial contamination of this formulation.

Newer formulations contain preservatives that provide a 28-day shelf life once the bottle is opened. Propofol can be mixed with sodium thiopental in a 1:1 mixture; these drugs are physically and chemically compatible. However, do not mix with other drugs unless their compatibility is known or studied. Propofol has a pH of 7-8.5. Keep away from light. Store at 4–22°C. Do not freeze.

Consequences and side effects

The drug is safer than many of its previously used analogues. However, it also has accompanying actions. Side effects of Propofol include:

• arterial hypotension (low blood pressure),
• bradycardia (slow heart rate),
• depression of respiratory function (up to short-term apnea).

In rare cases, convulsions, allergic reactions may occur, and after waking up - nausea, vomiting, and headache. The vast majority of patients have a completely normal reaction to Propofol.

To minimize side effects, a doctor should prescribe Propofol based on preliminary tests, which should determine how safe the use of this drug is for a particular patient.

In addition, constant monitoring of the patient’s condition under anesthesia and the availability of resuscitation equipment in the clinic, incl. apparatus for artificial ventilation of the lungs.

Propofol can only cause harm if the permissible dosage is exceeded. But provided that the drug is prescribed correctly and the anesthesiologist is equipped with all the means necessary for control, the occurrence of such a situation is excluded.

Indications and clinical use

Propofol is used as a short-term injectable anesthetic.

It can be used as an anesthesia induction drug followed by inhalation with halothane or isoflurane. The advantage of propofol over other agents is its smooth and rapid recovery. It can be used with acepromazine, diazepam, alpha2-agonists (eg, dexmedetomidine), butorphanol, and inhalational anesthetics. An additional use of propofol is the treatment of status epilepticus. It has been used safely and effectively for short-term induction and surgical procedures. Propofol is also suitable for procedures that require repeated episodes of anesthesia in dogs and cats without causing side effects.

Recommended dose of Propofol

The dosage of Propofol depends on age, body weight, and various individual characteristics. The starting dosage for sleep induction for the average adult is approximately 40 mg every 10 seconds, or 2-2.5 mg/kg body weight. For children over 8 years of age, approximately the same dosages are used; for younger children, higher doses are possible.

The maintenance dosage to maintain anesthesia is 4-12 mg/kg/h for adults and 9-15 mg/kg/h for children.

Propofol-Novo, 10 mg/ml, emulsion for intravenous administration, 50 ml, 1 pc.

The drug should only be used in hospitals or appropriately equipped day hospitals by personnel with special training in anesthesiology or intensive care. Respiratory and circulatory functions should be constantly monitored. Conditions must be provided to maintain airway patency, mechanical ventilation, as well as conditions for resuscitation measures. For sedation during surgical or diagnostic procedures, the drug should not be administered by personnel performing the surgical procedure or diagnostic procedure.

The dose of the drug must be selected individually, taking into account premedication and the patient's response.

As a rule, when using the drug, additional administration of analgesic drugs is required.

ADULTS

Induction of general anesthesia

Regardless of whether the patient is premedicated or not, it is recommended that the dose be titrated (as a bolus injection or infusion of approximately 40 mg (4 ml) every 10 seconds for healthy adult patients) based on the patient's response until clinical signs of anesthesia appear. . For most adult patients under the age of 55 years, the dose of the drug is 1.5–2.5 mg/kg body weight. The total dose required can be reduced by reducing the rate of administration (2 to 5 mL (20 to 50 mg/min)). For patients over the age of 55 years, a lower dose is usually required. Patients in ASA (American Society of Anesthesiologists) classes III and IV should be given the drug at a slower rate (approximately 2 ml (20 mg) every 10 seconds).

Maintaining general anesthesia

Anesthesia can be maintained by administering Propofol-Novo by continuous infusion or repeated bolus injections to prevent signs of insufficient anesthesia. Normalization of the condition after anesthesia usually occurs quickly, so it is important to maintain the administration of Propofol-Novo until the end of the procedure.

Continuous infusion

The required infusion rate varies widely depending on individual patients, but generally a rate of 4–12 mg/kg/h will maintain adequate anesthesia.

For less stressful surgical procedures, such as minimally invasive ones, a maintenance dose of about 4 mg/kg/h is usually sufficient.

For elderly patients, patients with unstable general condition, with impaired cardiac function, hypovolemia and patients of risk classes III - IV according to the ASA classification, the dose may be reduced depending on the severity of the condition and the method of anesthesia.

Repeat bolus injection

If a technique involving repeated bolus injections is used, increasing doses from 25 mg (2.5 ml) to 50 mg (5 ml) are used in accordance with clinical practice. necessity.

In elderly patients, rapid bolus administration (single or multiple) is not advisable, as it can lead to cardiac and respiratory depression.

Sedation during intensive care

To ensure a sedative effect during intensive care, it is recommended to administer the drug by continuous infusion. The rate of infusion should depend on the depth of sedation required. For most patients, sufficient sedation can be achieved by administering the drug at a dose of 0.3-4 mg/kg/h. The upper limit of infusion rate to provide sedation in intensive care settings should not exceed 4 mg/kg/h, unless the benefits outweigh the risks. Propofol-Novo is not indicated for providing sedation in intensive care patients under the age of 16 years.

Administration of the drug using the TCI system (target concentration infusion) for sedation of patients during intensive care is not recommended.

Sedation for surgical and diagnostic procedures

To provide sedation during surgical or diagnostic procedures, propofol can be used alone or in combination with local or regional anesthesia. The rate of drug administration and dose should be individualized and titrated depending on clinical response. For most patients, administration of 0.5 to 1 mg/kg of the drug over 1–5 minutes is necessary for sedation to occur.

Maintenance of sedation can be achieved by titrating the drug infusion to the required level of sedation; for most patients, 1.5 to 4.5 mg/kg/hour is needed. In addition to infusion, a bolus of 10 to 20 mg can be administered if a rapid onset of deep sedation is required. For patients over 55 years of age and for patients of risk class III - IV according to the ASA classification, a reduction in the dose and rate of drug administration may be required.

CHILDREN

Administration of propofol to children using the ICC system is not recommended.

Induction of general anesthesia

Propofol-Novo is not recommended for induction of anesthesia in children under 1 month of age. When used as induction of anesthesia in children, Propofol-Novo is recommended to be administered slowly until clinical signs of anesthesia appear. The dose should be adjusted according to age and/or body weight.

For most children over 8 years of age, approximately 2.5 mg/kg body weight is typically required for induction. For children under 8 years of age, especially those aged 1 month to 3 years, the required dose may be higher (2.5–4 mg/kg).

For children of III – IV risk classes according to the ASA classification, reduced doses are recommended. Maintaining general anesthesia

Propofol-Novo is not recommended for maintaining anesthesia in children under 1 month of age.

Anesthesia can be maintained by administering Propofol-Novo as a continuous infusion or repeated bolus injections to prevent clinical signs of insufficient anesthesia. The required rate of infusion varies widely depending on individual patients, but a rate of 9–15 mg/kg/hour will generally maintain adequate anesthesia.

Children aged 1 month to 3 years may require higher doses of the drug within the recommended dosage range compared to older children. The dose should be adjusted individually and special attention should be paid to monitoring the adequacy of anesthesia.

For children of III – IV risk classes according to the ASA classification, lower doses are recommended.

Sedation during intensive care

Propofol is not recommended for sedation in children 16 years of age and younger as its safety and effectiveness in this use have not yet been confirmed. Serious adverse events, including deaths, have been reported with unlicensed use of propofol, although a causal relationship to the drug has not been established. These adverse events were most often observed in children with respiratory tract infections who were administered doses higher than recommended adult doses.

Sedation for surgical and diagnostic procedures

Propofol is not recommended for use in children under 1 month of age.

To provide sedation during surgical or diagnostic procedures, propofol can be used alone or in combination with local or regional anesthesia. The rate of drug administration and dose should be individualized and titrated depending on clinical response. For most patients, 1 to 2 mg/kg of the drug must be administered over at least 1 minute to achieve sedation.

Maintenance of sedation can be achieved by titrating the drug infusion to the required level of sedation; for most patients, 1.5 to 9 mg/kg/hour is needed. In addition to infusion, a bolus dose of up to 1 mg/kg can be administered if a rapid onset of deep sedation is required.

In patients of risk class III - IV according to the ASA classification, a reduction in the dose and rate of drug administration may be required.

Method of administration

For intravenous administration.

For single use only.

The bottle should be shaken before use.

If, after shaking, separation of the emulsion is observed, the drug cannot be used.

Use only if the emulsion is homogeneous and the packaging is not damaged. Before use, treat the rubber stopper of the bottle with alcohol.

Since Propofol-Novo is a fat emulsion that does not contain preservatives and does not have antimicrobial activity, the drug can serve as a favorable environment for the rapid growth of microorganisms.

The emulsion should be drawn into a sterile syringe or dropper immediately after opening the package. Administration of the drug must be started without delay.

During the entire period of administration of Propofol-Novo, it is necessary to follow the rules of aseptic work with the drug and the system for parenteral infusion.

When co-administering Propofol-Novo with other drugs and solutions in the same system, it is recommended that the latter be administered through a tee with a valve in close proximity to the site of drug administration. Propofol-Novo cannot be administered through a microbiological filter.

The drug Propofol-Novo and any infusion system containing Propofol-Novo are intended only for a single administration to one patient.

Any remnants of Propofol-Novo emulsion after use should be destroyed.

The total time of drug administration through one infusion system should not exceed 12 hours. After 12 hours of use, the infusion system containing Propofol-Novo or the container with the drug should be replaced.

The drug does not cause an analgesic effect and therefore, as a rule, in addition to Propofol-Novo, it is necessary to administer additional analgesics.

For infusion, Propofol-Novo can be used undiluted or diluted with only a 5% dextrose solution in PVC infusion bags or glass infusion bottles. Dilution, the ratio of which should not exceed 1:5 (2 mg propofol per 1 ml), should be carried out under aseptic conditions immediately before administration; the solution should be used within 6 hours after dilution.

When using diluted Propofol-Novo, it is recommended that the volume of 5% dextrose solution removed from the infusion bag during the dilution process is completely replaced by the volume of Propofol-Novo emulsion (see table below for dilution and simultaneous use).

The diluted drug can be administered using various infusion control techniques, but the use of the infusion set alone does not completely avoid accidental uncontrolled infusion of large volumes of diluted Propofol-Novo drug. Burettes, drop counters or metering pumps should always be part of the infusion line. The risk of uncontrolled infusion should always be taken into account when calculating the maximum volume of Propofol-Novo in the burette.

When using undiluted Propofol-Novo to maintain anesthesia, it is recommended to always use equipment such as a syringe pump or volumetric infusion pump to control the rate of administration. Compatibility of electronic equipment must be ensured.

Propofol-Novo can be administered through a Y-shaped connector installed near the injection site when infusing the following drugs:

• 5% dextrose solution for infusion;
• 0.9% sodium chloride solution for infusion;
• 4% dextrose solution with 0.18% sodium chloride solution for infusion.

A prefilled glass syringe has a lower fractional plunger resistance than a plastic disposable syringe and is easier to move. Therefore, when administering Propofol-Novo manually using a pre-filled syringe, the infusion system between the syringe and the patient should not be left open unless supervised by medical personnel.

Adequate compatibility must be ensured when a pre-filled syringe is used in a syringe pump. In particular, the pump design must prevent siphoning and must have a blockage alarm at a pressure of no more than 1000 mmHg. Art. If a programmable or equivalent pump is used, which allows the use of different syringes, then in the case of using the drug Propofol-Novo in the form of a pre-filled syringe, only the “B - D” 50/60 ml PLASTIPAK mode is selected.

Propofol-Novo can be pre-mixed with alfentanil injection containing 500 mcg/ml alfentanil in a volume ratio of 20:1 to 50:1. Mixtures should be prepared under aseptic conditions and used within 6 hours of preparation.

To reduce pain at the beginning of administration, Propofol-Novo can be mixed with 0.5% or 1% lidocaine injection solution that does not contain preservatives (see table below for dilution and simultaneous use). In this case, preliminary skin tests should be performed to determine the tolerance of lidocaine.

Attention: lidocaine is contraindicated in patients with hereditary acute porphyria!

Guidelines for target concentrations of propofol are given below. Due to individual differences in the pharmacokinetics and pharmacodynamics of propofol in patients, regardless of whether they are premedicated, the target concentration of propofol should be titrated depending on the clinical response in order to achieve the required depth of anesthesia.

Induction and maintenance of general anesthesia

In adult patients under 55 years of age, anesthesia can usually be induced with target propofol concentrations ranging from 4 to 8 mcg/mL. An initial target concentration of 4 mcg/mL is recommended for patients who are premedicated and a concentration of 6 mcg/mL is recommended for patients who are not premedicated. The induction time at these target concentrations is typically in the range of 60–120 seconds. Higher target concentrations will result in rapid induction of anesthesia but may cause greater hemodynamic and respiratory depression.

A lower initial target concentration should be used in patients aged 55 years and older and in ASA risk classes III and IV. The target concentration can then be gradually increased by 0.5 to 1 mcg/ml at 1-minute intervals to achieve gradual induction of anesthesia.

Supplemental analgesia is generally necessary, and the amount by which target concentrations can be reduced to maintain anesthesia will depend on the amount of analgesic administered simultaneously. Target propofol concentrations ranging from 3 to 6 mcg/mL usually maintain an adequate level of anesthesia.

The predicted concentration of propofol for awakening is usually in the range of 1 to 2 mcg/ml, and depends on the level of analgesia during the period of maintenance of anesthesia.

Providing sedation during intensive care

Target blood concentrations of propofol in the range of 0.2–2 mcg/mL are usually required. Administration of the drug should begin with a low target concentration, which should be titrated depending on the patient's response to achieve the required depth of sedation.

Dilution of the drug Propofol-Novo and simultaneous use with other drugs or infusion solutions.

The use of lidocaine for dilution is contraindicated in children under 12 years of age.

If lidocaine is used to dilute the drug, it is necessary to take into account information on the safety of lidocaine.

Muscle relaxants such as atracurium and mivacurium can be administered through the infusion system used to administer Propofol-Novo only after it has been flushed.

The duration of use should not exceed 7 days.

Use of propofol

Medication-induced sleep during dental treatment is used in several cases. First of all, this is dental phobia - a pathological fear of dental treatment. This is not just a fear that a strong-willed adult can cope with. As a rule, this is a series of involuntary nervous and physiological reactions that a person cannot control. In addition, a long complex operation, even in the absence of pain, often causes stress and deterioration of physical condition - increased stress on the heart and vascular system, exacerbation of chronic diseases, etc. Therefore, indications for the use of Propofol include:

• dental phobia,
• long operations with a high level of injury,
• increased sensitivity to pain,
• inability to establish contact with a doctor in some patients.

The drug is used to induce medicinal sleep in both adults and children, and even children under 1 year of age are not an obstacle.

Similar drugs:

• Sodium oxybate Solution for intravenous and intramuscular administration
• Halothane Inhalation aerosol
• Propofol Lipuro Emulsion for infusion
• Calypsol Injection solution
• Ketalar Solution for intravenous and intramuscular administration
• Sodium oxybutyrate Substance-powder
• Ketanest Solution for intravenous and intramuscular administration
• Sodium oxybutyrate Solution for intravenous administration
• Propovan Emulsion for infusion
• Thiopental Lyophilisate for the preparation of solution for intravenous administration

** The Drug Directory is intended for informational purposes only. For more complete information, please refer to the manufacturer's instructions. Do not self-medicate; Before starting to use Propofol Kabi, you should consult a doctor. EUROLAB is not responsible for the consequences caused by the use of information posted on the portal. Any information on the site does not replace medical advice and cannot serve as a guarantee of the positive effect of the drug.

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** Attention! The information presented in this medication guide is intended for medical professionals and should not be used as a basis for self-medication. The description of the drug Propofol Kabi is provided for informational purposes and is not intended for prescribing treatment without the participation of a doctor. Patients need to consult a specialist!

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Contraindications to the use of Propofol

The drug cannot be used by everyone. Absolute contraindications for the use of Propofol are:

• presence of allergies to the components of the drug,
• children's age up to 1 month.

It is also not recommended to use Propofol during pregnancy, because it penetrates the placental barrier. During the feeding period, the use of the medicine is allowed, provided that the woman does not feed for several hours after using the drug.

Relative contraindications for Propofol:

• serious diseases of the cardiovascular system,
• respiratory diseases,
• pathologies of the liver and kidneys,
• anemia,
• epilepsy,
• lipid metabolism disorders.

In all these cases, consultation with a specialized doctor is necessary. In case of stable remission of the disease, in the absence of a conflict between Propofol and the medications taken by the patient and some other circumstances, the doctor may authorize the use of Propofol.

Contraindications and precautions

Propofol may cause apnea, hypoxia and cyanosis upon induction.

Supplemental oxygen should be available to prevent side effects. Do not use in animals with hypotension. When propofol is used to sedate animals during intradermal skin testing, it may cause a higher number of false-positive reactions. Propofol should not be used alone for pain relief in horses or in combination with other sedatives or premedications.

Interactions of propofol with other drugs. Propofol can be used safely with several other anesthetics. It was combined with sodium thiopental (2.5%) in a 1:1 mixture without loss of effectiveness. Propofol has been used with atropine, glycopyrrolate, acepromazine, xylazine, oxymorphone, halothane and isoflurane, without any interactions.

Analogs

Propofol can, if necessary, be replaced with other drugs of similar action. Propofol analogues from the group of non-inhalational anesthetics:

• brietal,
• hexenal,
• ketamine,
• hypnomidate.

These drugs have a comparable effect in terms of mechanism and results (stimulation of GABA and suppression of excitatory neurotransmitters), but it must be borne in mind that almost all of them have more severe side effects and provide a more difficult recovery from anesthesia (drowsiness, headache, confusion, hallucinations etc.) compared to Propofol. In addition, not all of them can be used in childhood.

Of the inhaled analogues of Propofol, Sevoran has proven itself well. This drug has the same effect, is slightly more effective and safe, but it is a gas and the method of administration is less convenient - inhalation.

Propofol is currently the most successful drug for anti-stress treatment in dentistry, widely used for both adults and children of all age groups.

How do we ensure the safety of treatment?

• Our clinics are accredited by the joint international commission - JCI. The JCI certificate means that we have the highest requirements for treatment safety - at the level of the best medical centers in the world.
• When treating during sleep, we use anesthesia monitoring according to the extended Harvard standard. We have the most modern General Electric device - a patient vital signs monitor. It guarantees accurate and reliable data. We track absolutely everything that is necessary.
• Treatment under anesthesia takes place only in the operating room. We maintain a special sterility regime.
• In addition to the Harvard standard, we use BIS monitoring.