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Propofol (Emulsion) Instructions for Use

ATC Code

N01AX10 (Propofol)

Active Substance

Propofol (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Intravenous anesthesia preparation

Pharmacotherapeutic Group

Anesthetics; general anesthetics; other general anesthetics

Pharmacological Action

A non-inhalation anesthesia agent. When administered intravenously, the state of anesthesia occurs within approximately 30 seconds, without pronounced signs of excitation.

After administration, Propofol is distributed throughout the body tissues and undergoes biotransformation primarily in the liver with the formation of inactive conjugates.

The onset of anesthesia under the influence of propofol is apparently due to a nonspecific effect on the lipids of CNS neuron membranes, resulting in disruption of ion channel function, particularly sodium channels.

Furthermore, it has been shown that propofol enhances GABA-ergic processes in the brain. Propofol has virtually no analgesic effect.

Recovery of function after cessation of propofol’s action occurs quickly.

Indications

For induction of anesthesia and for maintenance of general anesthesia. For providing a sedative effect during mechanical ventilation.

ICD codes

ICD-10 code Indication
Z51.4 Preparatory procedures for subsequent treatment or examination, not elsewhere classified
ICD-11 code Indication
QB9A Preparatory procedures for subsequent treatment

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Emulsion

For induction of anesthesia in adult patients with average body weight, administer intravenously 40 mg every 10 seconds until clinical signs of anesthesia appear.

In most cases, the total dose is 2-2.5 mg/kg. For children over 8 years of age, administer slowly intravenously until clinical signs of anesthesia appear.

The dose should be adjusted according to age and/or body weight; the average dose is 2.5 mg/kg. For children under 8 years of age, drug doses may be higher.

For adults and children over 3 years of age with ASA grades 3 and 4, Propofol should be administered in lower doses.

For maintenance of anesthesia by continuous infusion, adults are administered 4-12 mg/kg/h. For children, the infusion rate is 9-15 mg/kg/h.

Repeated administration as a bolus in doses necessary to maintain adequate anesthesia is also possible.

To provide a sedative effect during artificial ventilation of the lungs in adults, Propofol is administered at a dose of 300 mcg/kg/h.

Adverse Reactions

When used for induction of anesthesia, arterial hypotension, bradycardia, and transient apnea are possible.

Rarely: convulsions, opisthotonus, pulmonary edema. During the recovery period, headache, nausea, and vomiting are possible.

In some cases: postoperative fever.

In isolated cases: angioneurotic edema, bronchospasm, erythema, sexual disinhibition; at doses exceeding 4 mg/kg/h, isolated cases of rhabdomyolysis have been reported.

Local reactions: phlebitis, thrombosis.

Contraindications

History of allergic reactions to propofol administration, children under 1 month of age, children and adolescents under 16 years of age (for providing a sedative effect during mechanical ventilation).

Use in Pregnancy and Lactation

Should not be used in obstetric practice as an anesthetic agent, as Propofol crosses the placental barrier and can cause neonatal depression.

It can be used as a general anesthetic during termination of pregnancy in the first trimester.

Propofol is excreted in small amounts in breast milk. It is believed that this is not dangerous for the child, provided that the mother does not breastfeed the child for several hours after propofol administration.

Use in Hepatic Impairment

Propofol should be used with caution in liver diseases.

Use in Renal Impairment

Propofol should be used with caution in kidney diseases.

Pediatric Use

Contraindicated in children under 1 month of age, children and adolescents under 16 years of age (for providing a sedative effect during mechanical ventilation).

Geriatric Use

Propofol should be used with caution in elderly patients.

Special Precautions

Propofol should be used with caution in concomitant hypovolemia, epilepsy, lipid metabolism disorders, diseases of the cardiovascular system, respiratory organs, liver and kidneys, and in elderly patients.

To prevent bradycardia, it is advisable to include m-cholinolytics in the premedication complex.

Drug Interactions

With simultaneous use of propofol with muscle relaxants, inhalational anesthetics, and analgesics, an enhancement of the depressant effect on respiration and a decrease in blood pressure are possible, which enhances the effect of propofol.

With simultaneous use of propofol and opioid analgesics, the risk of respiratory depression increases.

After fentanyl administration, the plasma level of propofol may temporarily increase.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Marketing Authorization Holder

Fresenius Kabi Deutschland, GmbH (Germany)

Manufactured By

Fresenius Kabi Austria, GmbH (Austria)

Dosage Form

Bottle Rx Icon Propofol Fresenius Emulsion for intravenous administration 10 mg/1 ml: amp. 20 ml 5 pcs.

Dosage Form, Packaging, and Composition

Emulsion for intravenous administration white or almost white, homogeneous.

1 ml
Propofol 10 mg

Excipients: soybean oil – 100 mg, glycerol – 22.5 mg, egg yolk phospholipids – 12 mg, oleic acid – 0.4-0.8 mg (for pH adjustment), sodium hydroxide – 0.05-0.11 mg (for pH adjustment), water for injections – up to 1 ml.

20 ml – ampoules of colorless glass (5) – cardboard packs.

Marketing Authorization Holder

Fresenius Kabi Deutschland, GmbH (Germany)

Manufactured By

Fresenius Kabi Austria, GmbH (Austria)

Dosage Form

Bottle Rx Icon Propofol Fresenius Emulsion for intravenous administration 10 mg/1 ml: fl. 50 ml 1 or 10 pcs.

Dosage Form, Packaging, and Composition

Emulsion for intravenous administration white or almost white, homogeneous.

1 ml
Propofol 10 mg

Excipients: soybean oil – 100 mg, glycerol – 22.5 mg, egg yolk phospholipids – 12 mg, oleic acid – 0.4-0.8 mg (for pH adjustment), sodium hydroxide – 0.05-0.11 mg (for pH adjustment), water for injections – up to 1 ml.

50 ml – vials of colorless glass (1) – cardboard boxes.
50 ml – vials of colorless glass (10) – cardboard boxes.

Marketing Authorization Holder

Fresenius Kabi Deutschland, GmbH (Germany)

Manufactured By

Fresenius Kabi Austria, GmbH (Austria)

Dosage Form

Bottle Rx Icon Propofol Fresenius Emulsion for intravenous administration 10 mg/1 ml: bottle 100 ml 1 or 10 pcs.

Dosage Form, Packaging, and Composition

Emulsion for intravenous administration white or almost white, homogeneous.

1 ml
Propofol 10 mg

Excipients: soybean oil – 100 mg, glycerol – 22.5 mg, egg yolk phospholipids – 12 mg, oleic acid – 0.4-0.8 mg (for pH adjustment), sodium hydroxide – 0.05-0.11 mg (for pH adjustment), water for injections – up to 1 ml.

100 ml – vials of colorless glass (1) – cardboard boxes.
100 ml – vials of colorless glass (10) – cardboard boxes.

Marketing Authorization Holder

Hana Pharmaceutical, Co. Ltd. (Republic of Korea)

Dosage Form

Bottle Rx Icon Propofol Emulsion for intravenous administration 10 mg/1 ml: amp. 20 ml 5 pcs.

Dosage Form, Packaging, and Composition

Emulsion for intravenous administration 1 ml 1 amp.
Propofol 10 mg 200 mg

20 ml – ampoules (5) – plastic contour packs (1) – cardboard packs.

Marketing Authorization Holder

Fresenius Kabi Deutschland, GmbH (Germany)

Manufactured By

Fresenius Kabi Austria, GmbH (Austria)

Dosage Form

Bottle Rx Icon Propofol Kabi Emulsion for intravenous administration 10 mg/1 ml: amp. 20 ml 5 pcs.

Dosage Form, Packaging, and Composition

Emulsion for intravenous administration white, homogeneous, with a weak phenolic odor.

1 ml 1 amp.
Propofol 10 mg 200 mg

Excipients: soybean oil – 50 mg, medium-chain triglycerides – 50 mg, egg yolk phospholipids – 12 mg, glycerol – 22.5 mg, oleic acid 0.4-0.8 mg, sodium hydroxide – q.s. (0.05-0.11 mg), water for injections – up to 1 ml.

20 ml – ampoules of colorless glass (5) – contour cell packs (1) – cardboard packs.

Marketing Authorization Holder

Fresenius Kabi Deutschland, GmbH (Germany)

Manufactured By

Fresenius Kabi Austria, GmbH (Austria)

Dosage Form

Bottle Rx Icon Propofol Kabi Emulsion for intravenous administration 10 mg/1 ml: 50 ml vial 1, 5, or 10 pcs.

Dosage Form, Packaging, and Composition

Emulsion for intravenous administration white, homogeneous, with a weak phenolic odor.

1 ml
Propofol 10 mg

Excipients: soybean oil – 50 mg, medium-chain triglycerides – 50 mg, egg yolk phospholipids – 12 mg, glycerol – 22.5 mg, oleic acid 0.4-0.8 mg, sodium hydroxide – q.s. (0.05-0.11 mg), water for injections – up to 1 ml.

50 ml – vials of colorless glass (1) – cardboard packs.
50 ml – vials of colorless glass (5) – cardboard packs.
50 ml – vials of colorless glass (10) – cardboard packs.

Marketing Authorization Holder

Fresenius Kabi Deutschland, GmbH (Germany)

Manufactured By

Fresenius Kabi Austria, GmbH (Austria)

Dosage Form

Bottle Rx Icon Propofol Kabi Emulsion for intravenous administration 20 mg/1 ml: 50 ml vial 1 or 10 pcs.

Dosage Form, Packaging, and Composition

Emulsion for intravenous administration white, homogeneous, with a weak phenolic odor.

1 ml
Propofol 20 mg

Excipients: soybean oil – 50 mg, medium-chain triglycerides – 50 mg, egg yolk phospholipids – 12 mg, glycerol – 22.5 mg, oleic acid 0.4-0.8 mg, sodium hydroxide – q.s. (0.05-0.11 mg), water for injections – up to 1 ml.

50 ml – vials of colorless glass (1) – cardboard packs.
50 ml – vials of colorless glass (10) – cardboard packs.

Marketing Authorization Holder

Velpharm-M, LLC (Russia)

Manufactured By

Velpharm, LLC (Russia)

Dosage Form

Bottle Rx Icon Propofol Velpharm Emulsion for intravenous administration 10 mg/ml: 20 ml amp. 5, 10, 100, 240, 250, 480, or 500 pcs.

Dosage Form, Packaging, and Composition

Emulsion for intravenous administration white or almost white with a slight characteristic odor; slight separation may be observed upon prolonged standing, disappearing after shaking.

1 ml
Propofol 10 mg

Excipients: soybean oil, egg yolk phospholipids, glycerol (glycerin), disodium edetate dihydrate (calculated as disodium edetate), 2M sodium hydroxide solution, water for injections.

20 ml – ampoules (5) – cardboard packs.
20 ml – ampoules (10) – cardboard packs.
20 ml – ampoules (100) – cardboard packs (for hospitals).
20 ml – ampoules (240) – cardboard packs (for hospitals).
20 ml – ampoules (250) – cardboard packs (for hospitals).
20 ml – ampoules (480) – cardboard packs (for hospitals).
20 ml – ampoules (100) – cardboard packs (for hospitals).
20 ml – ampoules (500) – cardboard packs (for hospitals).

Marketing Authorization Holder

Binergia JSC (Russia)

Manufactured By

Armavir Biopharmaceutical Plant, FSE (Russia)

Dosage Form

Bottle Rx Icon Propofol-Binergia Emulsion for intravenous administration 20 mg/1 ml: 50 ml vial

Dosage Form, Packaging, and Composition

Emulsion for intravenous administration white or almost white, with a slight characteristic odor; slight separation may be observed upon prolonged standing, disappearing after shaking.

1 ml
Propofol 20 mg

Excipients: soybean oil, medium-chain triglycerides, egg lecithin, glycerol, disodium edetate, sodium oleate, water for injections.

50 ml – vials (1) – cardboard packs.

Marketing Authorization Holder

Binergia JSC (Russia)

Manufactured By

Biokhimik, JSC (Russia)

Or

Armavir Biopharmaceutical Plant, FSE (Russia)

Dosage Form

Bottle Rx Icon Propofol-Binergia Emulsion for intravenous administration 10 mg/1 mL: amp. 20 mL 5 or 10 pcs.

Dosage Form, Packaging, and Composition

Emulsion for intravenous administration white or almost white, with a slight characteristic odor; slight separation may be observed upon prolonged standing, disappearing after shaking.

1 ml
Propofol 10 mg

Excipients: soybean oil – 50 mg, medium-chain triglycerides (medium-chain triglycerides) – 50 mg, egg lecithin (egg yolk phospholipids) – 12 mg, glycerol – 25 mg, sodium oleate – 0.3 mg, water for injections – up to 1 ml.

20 ml – ampoules (5) – plastic contour packs (1) – cardboard packs.
20 ml – ampoules (5) – plastic contour packs (2) – cardboard packs.

Marketing Authorization Holder

Extrempharm-S, LLC (Russia)

Manufactured By

Armavir Biopharmaceutical Plant, FSE (Russia)

Dosage Form

Bottle Rx Icon Propofol-Egen Emulsion for intravenous administration 10 mg/1 ml: 20 ml amp. 5 or 10 pcs., 50 ml or 100 ml vial 1, 5, or 10 pcs.

Dosage Form, Packaging, and Composition

Emulsion for intravenous administration white or almost white, with a slight characteristic odor; slight separation may be observed upon prolonged standing, which disappears after shaking.

1 ml
Propofol 10 mg

Excipients: soybean oil, medium-chain triglycerides (medium-chain triglycerides), egg lecithin (egg yolk phospholipids), glycerol, oleic acid, sodium hydroxide, water for injections.

20 ml – ampoules of colorless glass (5) – contour plastic packs (1) – cardboard packs.
20 ml – ampoules of colorless glass (5) – contour plastic packs (2) – cardboard packs.
20 ml – ampoules of colorless glass (5) – cardboard boxes with partitions.
50 ml – vials of colorless glass (1) – cardboard packs.
50 ml – vials of colorless glass (5) – cardboard boxes with partitions.
50 ml – vials of colorless glass (10) – cardboard boxes with partitions.
100 ml – vials of colorless glass (1) – cardboard packs.
100 ml – vials of colorless glass (5) – cardboard boxes with partitions.
100 ml – vials of colorless glass (10) – cardboard boxes with partitions.

Marketing Authorization Holder

B.Braun Melsungen AG (Germany)

Dosage Form

Bottle Rx Icon Propofol-Lipuro Emulsion for intravenous administration 20 mg/1 ml: 50 ml vial 10 pcs.

Dosage Form, Packaging, and Composition

Emulsion for intravenous administration milky-white, ‘oil-in-water’ type, with a weak phenolic odor.

1 ml
Propofol 20 mg

Excipients: soybean oil, medium-chain triglycerides, egg phospholipids for injections, glycerol, sodium oleate, water for injections.

50 ml – vials of colorless glass (10) – cardboard boxes (for hospitals).

Marketing Authorization Holder

B.Braun Melsungen AG (Germany)

Dosage Form

Bottle Rx Icon Propofol-Lipuro Emulsion for intravenous administration 1% (200 mg/20 ml): amp. 5 pcs.

Dosage Form, Packaging, and Composition

Emulsion for intravenous administration 1% 1 ml 1 amp.
Propofol 10 mg 200 mg

20 ml – ampoules (5) – cardboard packs.

Marketing Authorization Holder

B.Braun Melsungen AG (Germany)

Dosage Form

Bottle Rx Icon Propofol-Lipuro Emulsion for intravenous administration 1% (500 mg/50 ml): vial 1 or 10 pcs.

Dosage Form, Packaging, and Composition

Emulsion for intravenous administration 1% 1 ml 1 vial
Propofol 10 mg 500 mg

50 ml – vials (1) – cardboard packs.
50 ml – vials (10) (for hospitals) – cardboard boxes.

Marketing Authorization Holder

Novopharm-Biosynthesis Firm, LLC (Ukraine)

Dosage Form

Bottle Rx Icon Propofol-Novo Emulsion for infusion 10 ml/ml: 20 ml vial 5 pcs. or 50 ml vial 1 pc.

Dosage Form, Packaging, and Composition

Emulsion for infusion white or almost white, homogeneous, free from solid particles and large oil droplets.

1 ml
Propofol 10 mg

Excipients: soybean oil – 100 mg, lecithin – 12 mg, glycerol (glycerin) – 22.5 mg, sodium hydroxide – 0.013 mg, water for injections – up to 1 ml.

20 ml – glass vials (5) – contour cell packs (1) – cardboard packs.
50 ml – glass vials (1) – cardboard packs.

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