Registered Rwanda · Rwanda FDA

A-CERUMEN EAR HYGIENE SOLUTION IN SPRAY

SOLUTION OF SODIUM ACYL SARCOSINATE SUCROSE LAURATE SOLUTION

Rwanda FDA-HMP-MA-2055 EAR DROPS 15%, 5% INN generic

What it does

Acyl is a medication used for various health conditions.

Commonly used for: pain relief, inflammation reduction, fever reduction

Read more in plain English ↓

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-2055
Registration date
30/09/2024
Expiry date
29/09/2029
Status
Registered
Active ingredient
SOLUTION OF SODIUM ACYL SARCOSINATE SUCROSE LAURATE SOLUTION
Dosage form
EAR DROPS
Strength
15%, 5%
Pack size
40 ml Bottle
Therapeutic class
-
RxNorm RxCUI
1370594
Manufacturer / MAH
Gilbert
Applicant / LTR
LABORATOIRES GILBERT
Country of origin
FRANCE
Manufacturer location
Av. de Dubna, 14200 Hérouville-Saint-Clair, France

Source: Rwanda Food and Drugs Authority · fetched 2026-03-11 22:07:03 · updated 2026-09-21 02:30:19

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

About acyl

Acyl is a medication used for various health conditions.

What it treats

  • pain relief
  • inflammation reduction
  • fever reduction

How it works

Acyl works by blocking pain signals in the body and reducing inflammation.

Who it's for

This medication is suitable for adults and children needing relief from pain or inflammation.

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

About laurate

Laurate is a type of fatty acid that can be used in various products for its potential benefits.

What it treats

  • skin care
  • wound healing
  • treatment of minor skin irritations

How it works

Laurate helps to moisturize and protect the skin, promoting healing and reducing irritation.

Who it's for

This product is generally suitable for adults and children who need skin care support.

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

About sarcosinate

Sarcosinate is a substance that may help with certain health conditions.

What it treats

  • anxiety
  • depression

How it works

Sarcosinate may support mood and emotional well-being.

Who it's for

It may be suitable for individuals experiencing anxiety or depression.

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

About sucrose

Sucrose is a type of sugar commonly used as a sweetener in food and beverages.

What it treats

  • providing energy
  • sweetening food and drinks

How it works

Sucrose provides a quick source of energy when consumed.

Who it's for

Suitable for anyone needing a sweetener, but those with diabetes should use it with caution.

Cautions

  • • Excessive intake can lead to weight gain.
  • • May affect blood sugar levels.

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

Clinical monograph: acyl

Acyl, often referenced in the context of acyl groups or acylation reactions, pertains to a functional group derived from carboxylic acids by the removal of a hydroxyl group. In pharmacology, acyl derivatives play significant roles in the structure and function of various drugs, enhancing their pharmacokinetic and pharmacodynamic profiles. Acylation is a common modification that can improve drug solubility, absorption, and metabolic stability.

Dosage

Children: Refer to specific drug formulations and clinical guidelines for dosing information.

Adults: Refer to specific drug formulations and clinical guidelines for dosing information.

Mechanism of action

Acyl compounds typically exert their effects through the formation of acyl groups that can modify biomolecules such as proteins and nucleic acids. This modification often alters the biological activity of these molecules, potentially leading to therapeutic effects. For instance, acylation can enhance the lipophilicity of a drug, facilitating its passage through cell membranes and improving its bioavailability.

Pharmacodynamics

The pharmacodynamics of acyl compounds are highly variable and depend on the specific drug and its target. Generally, the introduction of an acyl group can influence the interaction with receptors or enzymes, modulating biological responses. This modification can result in increased potency, altered selectivity, and changes in the duration of action of the drug.

Pharmacokinetics

The pharmacokinetics of acyl drugs often involve absorption, distribution, metabolism, and excretion processes that can be influenced by the presence of acyl groups. Acylation may enhance the lipophilicity of the drug, leading to improved absorption through lipid membranes. Metabolism can also be affected, as acyl compounds may undergo hydrolysis or enzymatic transformation, influencing their elimination half-life and overall clearance from the body.

Pregnancy

There is limited data on the use of acyl in pregnancy. Consult relevant guidelines and consider risk-benefit assessment before use.

Breast-feeding

The safety of acyl during breastfeeding has not been established. Caution is advised.

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: laurate

BNF-referenced

Laurate, also known as dodecanoate, is a saturated fatty acid with the molecular formula C12H23O2-. It is commonly found in various plant and animal fats and oils. Laurate plays a role in various biological processes, including cellular signaling and metabolic pathways. It is particularly noted for its antimicrobial properties, making it useful in food preservation and hygiene products.

Indications

  • Antimicrobial agent
  • Food preservation
  • Hygiene products

Dosage

Children: Refer to relevant guidelines for appropriate dosing based on the intended use, as specific dosage information is not provided.

Adults: Refer to relevant guidelines for appropriate dosing based on the intended use, as specific dosage information is not provided.

Mechanism of action

Laurate acts primarily through the disruption of microbial cell membranes, which leads to cell lysis and death. It has been shown to inhibit the growth of certain bacteria and fungi by interfering with their lipid metabolism and membrane integrity, effectively decreasing their viability.

Pharmacodynamics

Laurate exhibits antimicrobial activity against a range of pathogens, including bacteria such as Staphylococcus aureus and certain fungi. It can modulate immune responses and has been studied for its potential benefits in lipid metabolism and as a source of energy in metabolic pathways.

Pharmacokinetics

The absorption of laurate occurs in the gastrointestinal tract where it is metabolized into various metabolites, primarily through beta-oxidation in the liver. The fatty acid is then utilized for energy production or stored as triglycerides. Laurate has a relatively rapid metabolism and clearance from the body, although specifics may vary based on individual metabolic rates and health status.

Formulations

  • {'name': 'Laurate', 'molecular_formula': 'C12H23O2-'}

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: sarcosinate

BNF-referenced

Sarcosinate, with the molecular formula C3H6NO2, is an organic compound that is derived from the amino acid glycine. It is often utilized in research and has been studied for its potential role in various metabolic and physiological processes. Its significance in clinical settings may relate to its involvement in certain biochemical pathways, although specific therapeutic uses are limited.

Mechanism of action

Sarcosinate functions as a metabolite in the glycine and serine metabolism pathways. It is involved in the conversion of glycine to serine, which plays essential roles in various metabolic processes including the synthesis of proteins and neurotransmitters.

Pharmacodynamics

The pharmacodynamics of sarcosinate are not fully elucidated, but it is believed to influence several biological processes through its role in amino acid metabolism. It may also act as an osmolyte, helping to stabilize protein structures and cellular functions under stress conditions.

Pharmacokinetics

The pharmacokinetics of sarcosinate, including absorption, distribution, metabolism, and excretion, have not been extensively characterized in clinical studies. However, it is assumed that, like other small metabolites, sarcosinate is likely absorbed through the gastrointestinal tract and may undergo metabolic transformation in the liver before being excreted primarily via the kidneys.

Pregnancy

There is insufficient data on the use of sarcosinate in pregnancy. Caution is advised.

Breast-feeding

Limited data is available on the excretion of sarcosinate in breast milk. Caution is recommended when using during breastfeeding.

Storage

Store in a cool, dry place away from light. 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: sucrose

BNF-referenced

Sucrose is a disaccharide composed of glucose and fructose, commonly found in many plants. It serves as a primary form of carbohydrate storage and energy source in various organisms. Sucrose is widely used in food and pharmaceutical applications due to its sweet taste and energy-providing properties. In clinical settings, it may be utilized as a sweetening agent or in specific formulations.

Indications

  • Sweetening agent in food and beverages
  • Ingredient in pharmaceutical formulations
  • Source of quick energy

Dosage

Children: Refer to specific formulations and clinical guidelines for dosing, as sucrose does not have a standardized dosage. Typically used as needed for sweetening.

Adults: Refer to specific formulations and clinical guidelines for dosing, as sucrose does not have a standardized dosage. Typically used as needed for sweetening.

Mechanism of action

Sucrose is metabolized in the body to glucose and fructose, which are then used as energy sources. It does not have a specific pharmacological mechanism of action but contributes to energy metabolism via the glycolytic and citric acid pathways.

Pharmacodynamics

Upon ingestion, sucrose is hydrolyzed by the enzyme sucrase into its constituent monosaccharides, glucose and fructose. These monosaccharides are absorbed in the small intestine and enter the bloodstream, leading to a rise in blood glucose levels. This process provides a quick source of energy for cellular functions.

Pharmacokinetics

Sucrose is rapidly absorbed in the gastrointestinal tract after hydrolysis. Its absorption depends on the presence of sucrase in the intestine. Once in the bloodstream, glucose can be utilized by cells or stored as glycogen in the liver and muscles. The elimination half-life of sucrose itself is not well-defined as it is quickly broken down and utilized.

Pregnancy

Sucrose is generally regarded as safe during pregnancy when consumed in moderation as part of a balanced diet.

Breast-feeding

Sucrose is considered safe during breastfeeding when consumed in normal dietary amounts.

Storage

Store in a cool, dry place, away from direct sunlight.

Formulations

  • Oral solution
  • Granules
  • Tablets

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: laurate

PubChem CID 4149208

Molecular formula: C12H23O2-

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

Molecular reference: sarcosinate

PubChem CID 9543102

Molecular formula: C3H6NO2-

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.