Registered Rwanda · Rwanda FDA

FRESENIUS PROPOVEN 1 % (20ML)

Each ml emulsion contains 10 mg propofol

Rwanda FDA-HMP-MA-1405 Emulsion for injection or infusion 10mg/ml INN generic

What it does

This medicine contains a variety of active ingredients that work together to help treat certain health conditions.

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Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

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Registration & product details

Registration no.
Rwanda FDA-HMP-MA-1405
Registration date
18/07/2024
Expiry date
17/07/2029
Status
Registered
Active ingredient
Each ml emulsion contains 10 mg propofol
Strength
10mg/ml
Pack size
10 glass ampoules with 20 ml emulsion
Therapeutic class
-
Manufacturer / MAH
Fresenius Kabi
Country of origin
SWEDEN
Manufacturer location
Rapsgatan 7, 754 50 Uppsala, Sweden

Source: Rwanda Food and Drugs Authority · fetched 2026-03-11 22:07:13 · updated 2026-09-21 02:30:20

Drug Interactions

2
Check interactions

Pharmacodynamic Warnings

Propofol appears in TABLE 6: Drugs that cause bradycardia

Propofol appears in TABLE 8: Drugs that cause hypotension

Propofol appears in TABLE 11: Drugs with CNS depressant effects

Moderate (1)

Propofol - increases concentration

Valproatepotentiallyincreasestheconcentrationofpropofol. Adjustdose.rTheoretical https://www.facebook.c (Books-Courses-Medic

Moderate Theoretical

Unknown (1)

The Active Component Of Sacituzumab Govitecan - increases exposure

Propofol is predicted to increase the exposure to the active component of sacituzumab govitecan. Theoretical Propranolol → see beta blockers, non-selective Propylthiouracil

Unknown Theoretical

Data from BNF 85 (British National Formulary). This is not a substitute for professional medical advice. Matched via: exact

Disclaimer: This information is sourced from Rwanda Food and Drugs Authority (Rwanda). Always consult a qualified healthcare professional before using any medication.

About contains

This medicine contains a variety of active ingredients that work together to help treat certain health conditions.

How it works

The active ingredients in this medicine perform specific functions to help your body in various ways, depending on the condition being treated.

Who it's for

This medicine is meant for individuals with specific health issues as determined by a healthcare provider.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

About emulsion

Emulsion is a mixture used to deliver medicine effectively, often in a liquid form.

What it treats

  • skin conditions
  • hydration of the skin
  • medication delivery

How it works

Emulsions help mix oil and water, making it easier for the body to absorb the medication.

Who it's for

Suitable for individuals needing topical treatment for skin issues or hydration.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

About propofol

Propofol is a medicine used to help with sedation during medical procedures.

What it treats

  • sedation during surgery
  • sedation for intensive care

How it works

Propofol works by slowing down brain activity, helping you relax and feel less aware of what is happening.

Who it's for

Propofol is for adults and children who need sedation for medical procedures.

Cautions

  • • Be careful if you are taking drugs that slow your heart rate.
  • • Use caution if you are on medications that lower blood pressure.
  • • Avoid using with other drugs that can make you feel sleepy or less alert.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: Propofol

BNF-referenced

Propofol is a short-acting intravenous anesthetic agent primarily used for the induction and maintenance of general anesthesia or sedation. It is characterized by its rapid onset and short duration of action, making it suitable for outpatient procedures and quick recovery times. Propofol is known for its smooth induction and is often preferred for its favorable pharmacokinetic profile.

Indications

  • Induction of general anesthesia
  • Maintenance of general anesthesia
  • Sedation for procedures

Dosage

Children: For children aged 1 month to 16 years, the usual dose for induction of anesthesia is 2.5–4 mg/kg, adjusted according to age, body weight, and response.

Adults: For induction of anesthesia, the usual adult dose is 1.5–2.5 mg/kg administered by slow intravenous injection. For maintenance, a continuous infusion of 4–12 mg/kg/hour may be used.

Mechanism of action

Propofol exerts its anesthetic effects by positively modulating the inhibitory neurotransmitter gamma-aminobutyric acid (GABA) at GABA-A receptors, leading to increased inhibitory neurotransmission and resulting in sedation and anesthesia.

Pharmacodynamics

As a sedative-hypnotic agent, propofol rapidly induces hypnosis with minimal excitation, typically within 40 seconds after intravenous administration. This rapid action is due to its high lipid solubility, allowing for quick distribution to the central nervous system. The drug also has a favorable recovery profile, with patients often regaining consciousness shortly after cessation of the infusion.

Pharmacokinetics

Propofol is highly lipophilic, leading to rapid distribution and a short half-life. It is primarily metabolized in the liver via conjugation and oxidation, and excreted in urine, mainly as metabolites. The drug has a volume of distribution of around 4 liters per kilogram, and its clearance is approximately 1.5 liters per minute, which results in a short duration of action.

Contra-indications

  • Hypersensitivity to propofol or any of its components
  • Severe respiratory depression
  • Acute porphyrias
  • Acute circulatory failure (shock)
  • Adrenal insufficiency

Adverse effects

  • Apnea
  • Hypotension
  • Nausea
  • Respiratory disorders
  • Skin reactions
  • Vascular pain
  • Vomiting
  • Arrhythmias
  • Cough
  • Hiccups
  • Hypertension
  • Muscle rigidity
  • Neuromuscular dysfunction
  • Nystagmus
  • Procedural complications

Interactions

  • Valproate may increase propofol concentration
  • Active component of sacituzumab govitecan may increase exposure to propofol

Precautions

  • Careful monitoring of fluids and electrolytes
  • Use with caution in patients with cardiovascular disease
  • Elderly patients may require dose adjustment
  • Avoid in patients with fixed cardiac output, hypovolaemia, or severe hypotension

Pregnancy

Propofol should be used during pregnancy only if clearly needed and after careful consideration of risks and benefits.

Breast-feeding

Propofol is excreted in breast milk; caution should be exercised when administered to breastfeeding women.

Storage

Store at room temperature, protect from light, and do not freeze.

Formulations

  • Emulsion for injection
  • 0.5% or 1% injection solution
BNF 85 (British National Formulary) p.1488 BNF for Children 2019-2020 p.854 PubChem / pathway

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Clinical monograph: contains

Contains is a term generally used to refer to formulations that include one or more active pharmaceutical ingredients. The specific effects, uses, and formulations depend on the particular drug in question. It is often used in the context of drug labels to inform about the components of a medication.

Dosage

Children: Refer to specific drug information for detailed dosage recommendations.

Adults: Refer to specific drug information for detailed dosage recommendations.

Mechanism of action

The mechanism of action varies depending on the specific drug that 'contains' certain active ingredients. Each compound will have its own unique pharmacological pathway and target within the body, which can include receptor modulation, enzyme inhibition, or other biochemical interactions.

Pharmacodynamics

Pharmacodynamics will depend on the active ingredients in the formulation. It generally encompasses the biochemical and physiological effects of the drug and its mechanisms of action, including the relationship between drug concentration and effect.

Pharmacokinetics

Pharmacokinetics involves the absorption, distribution, metabolism, and excretion of the specific active ingredients within the formulation. This can vary significantly based on the drug's chemical properties, route of administration, and individual patient factors.

Pregnancy

Consult with a healthcare provider before use, as safety during pregnancy has not been established.

Breast-feeding

Consult with a healthcare provider before use, as it is not known if this drug is excreted in human milk.

Storage

Store in a cool, dry place away from direct sunlight. Keep out of reach of children.

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Clinical monograph: emulsion

Emulsions are mixtures of two immiscible liquids, typically oil and water, stabilized by emulsifying agents. They are commonly used in pharmaceuticals to improve the solubility of lipophilic drugs, enhance drug absorption, and facilitate the delivery of nutrients. Emulsions can be administered orally, parenterally, or topically, depending on their formulation.

Indications

  • Nutritional support in patients unable to consume food orally
  • Parenteral nutrition
  • Drug delivery for lipophilic medications
  • Topical applications for skin conditions

Dosage

Children: Refer to specific product guidelines and clinical protocols for paediatric dosing.

Adults: Refer to specific product guidelines and clinical protocols for adult dosing.

Mechanism of action

Emulsions work by reducing the surface tension between the oil and water phases, allowing for the formation of stable droplets. This process is mediated by emulsifying agents, which can be surfactants or natural polymers that stabilize the emulsion and prevent phase separation. The absorption and bioavailability of drugs within the emulsion can be enhanced due to the increased surface area for absorption.

Pharmacodynamics

The pharmacodynamics of emulsions vary based on their composition and formulation. The presence of emulsifying agents can influence the release profile of the active ingredients, allowing for controlled or sustained release. Emulsions can also enhance the solubility of poorly water-soluble drugs, improving their therapeutic effects and minimizing side effects related to high concentrations of active ingredients.

Pharmacokinetics

The pharmacokinetics of emulsions depend on their route of administration and the specific properties of the drug contained within the emulsion. After administration, emulsions can be rapidly absorbed due to their small droplet size, leading to quicker onset of action. The distribution, metabolism, and excretion of the drug will follow the pharmacokinetic principles applicable to the active ingredients, influenced by their solubility and the emulsion's formulation.

Pregnancy

The safety of emulsions during pregnancy depends on the specific type and formulation. Consult relevant guidelines and specific product information.

Breast-feeding

Emulsions may be used while breastfeeding, but specific product information should be consulted to ensure safety.

Storage

Store at room temperature, away from light and moisture. Specific formulations may have unique storage requirements.

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Molecular reference: Propofol

PubChem CID 4943

Molecular formula: C12H18O

Mechanism of action

The action of propofol involves a positive modulation of the inhibitory function of the neurotransmitter gama-aminobutyric acid (GABA) through GABA-A receptors.

Pharmacodynamics

Propofol is a sedative-hypnotic agent for use in the induction and maintenance of anesthesia or sedation. Intravenous injection of a therapeutic dose of propofol produces hypnosis rapidly with minimal excitation, usually within 40 seconds from the start of an injection (the time for one arm-brain circulation).

Source: PubChem (NCBI) · pathways from PathBank, Reactome, WikiPathways & PharmGKB.

This drug in other countries

The same active ingredient registered across other registries we cover - including different brands.