Registered Rwanda · Rwanda FDA

GELOFUSINE 40MG/ML SOLUTION FOR INFUSION

Succinylated Gelatin 40mg/ml and Sodium Chloride 7.01mg/ml

Rwanda FDA-HMP-MA-0804 SOLUTION FOR INFUSION 40mg/ml INN generic

What it does

Gelatin is a substance often used in various food products and supplements. It is derived from animal collagen and is commonly used to help improve joint health and support digestion.

Commonly used for: joint pain, digestive health, skin elasticity

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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-0804
Registration date
08/01/2024
Expiry date
07/01/2029
Status
Registered
Active ingredient
Succinylated Gelatin 40mg/ml and Sodium Chloride 7.01mg/ml
Dosage form
SOLUTION FOR INFUSION
Strength
40mg/ml
Pack size
10 x 500ml Bottle
Therapeutic class
-
RxNorm RxCUI
4716
Manufacturer / MAH
B. Braun Medical
Country of origin
SWITZERLAND
Manufacturer location
Rte de Sorge 9, 1023 Crissier, Switzerland

Source: Rwanda Food and Drugs Authority · fetched 2026-03-11 22:07:24 · updated 2026-09-21 02:30:20

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

About gelatin

Gelatin is a substance often used in various food products and supplements. It is derived from animal collagen and is commonly used to help improve joint health and support digestion.

What it treats

  • joint pain
  • digestive health
  • skin elasticity

How it works

Gelatin helps to provide structure to the body, supporting joints, skin, and digestive tract by providing essential proteins.

Who it's for

Gelatin is suitable for people looking to support their joint health, improve skin appearance, or enhance digestion.

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

About succinylated

Succinylated is a substance used in various medical applications, primarily as an agent in certain treatments.

What it treats

  • used in anesthesia
  • used in muscle relaxation during surgery

How it works

It works by affecting muscle activity, helping to relax muscles during medical procedures.

Who it's for

It is typically used for patients undergoing surgery or certain medical procedures that require muscle relaxation.

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

Clinical monograph: Gelatin

BNF-referenced

Gelatin is a plasma substitute derived from protein obtained from plasma, serum, or normal placentas, with at least 95% of the protein being albumin. It is used to restore blood volume in patients with low blood volume conditions such as hypovolemic shock, burns, and during cardiopulmonary bypass procedures. Gelatin solutions can be isotonic, containing 3.5-5% protein, or concentrated, containing 15-25% protein.

Indications

  • Low blood volume
  • Hypovolemic shock
  • Burns
  • Cardiopulmonary bypass

Dosage

Children: Initially 10-20 mL per kilogram. Adjust according to the patient's condition and response, using 3.5-4% solution. Use under specialist supervision to mitigate the risk of fluid overload.

Adults: Dose according to requirements, typically administered intravenously. Consult product literature for specific dosing guidance.

Mechanism of action

Gelatin acts as a plasma expander by increasing the oncotic pressure in the vascular compartment, which helps to retain fluid within the bloodstream and restore circulating blood volume. This mechanism aids in maintaining blood pressure and improving tissue perfusion.

Pharmacodynamics

Gelatin solutions increase blood volume and improve hemodynamic stability in patients experiencing hypovolemic conditions. By drawing water into the vascular space, they help to counteract the effects of low blood volume, such as hypotension and compromised organ perfusion.

Pharmacokinetics

Gelatin is administered intravenously, and its effects can be observed relatively quickly. The half-life and the metabolic clearance depend on the formulation and concentration of the solution. Gelatin is gradually metabolized by macrophages and eliminated by the renal system. Close monitoring of fluid balance is essential, particularly in patients with cardiac or renal impairment.

Contra-indications

  • Severe liver disease
  • History of circulatory disease
  • Severe cardiac disease

Adverse effects

  • Fever
  • Flushing
  • Nausea
  • Urticaria
  • Rare or very rare shock

Interactions

  • Calcium salts

Precautions

  • Monitor cardiovascular and respiratory function
  • Correct dehydration when administering
  • Administer slowly to avoid rapid rise in blood pressure and cardiac failure
  • Increased capillary permeability

Pregnancy

Consult product literature for specific guidance regarding use in pregnancy.

Breast-feeding

Consult product literature for specific guidance regarding use in breastfeeding.

Storage

Store at controlled room temperature, protect from light. Refer to product-specific storage instructions.

Formulations

  • 5% solution for infusion
  • 20% solution for infusion
  • Concentrated solution (15-25% protein)
  • Isotonic solution (3.5-5% protein)
BNF 85 (British National Formulary) p.1181 BNF for Children 2019-2020 p.638 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: succinylated

Succinylated products, such as succinylated gelatins, are modified forms of gelatin that are used primarily in medical applications as plasma volume expanders. These agents are particularly useful in treating hypovolemia and in situations where blood volume needs to be restored quickly, such as in trauma or surgery. Succinylation enhances the solubility and stability of gelatin, making it more effective in expanding plasma volume.

Indications

  • Hypovolemia
  • Hemorrhagic shock
  • Fluid resuscitation during surgery
  • Trauma management

Dosage

Children: Refer to specific clinical guidelines or product information for dosing recommendations.

Adults: Refer to specific clinical guidelines or product information for dosing recommendations.

Mechanism of action

Succinylated gelatins work by increasing oncotic pressure within the blood vessels, which helps to draw fluid from surrounding tissues into the vascular space. This action increases blood volume and improves circulation. The succinylation process reduces the antigenicity of gelatin, which minimizes the risk of allergic reactions.

Pharmacodynamics

The pharmacodynamic effects of succinylated gelatins include rapid expansion of circulating blood volume, which can improve hemodynamic stability in patients experiencing hypovolemic shock. The increase in plasma volume leads to improved cardiac output and tissue perfusion, facilitating recovery from blood loss.

Pharmacokinetics

Succinylated gelatins are typically administered intravenously. They are rapidly distributed in the vascular compartment and exert their effects almost immediately. The metabolism of these products occurs in the liver, where they are broken down into smaller peptides and amino acids. The elimination of succinylated gelatins from the body is primarily through renal excretion. Because they are large molecules, they are not easily filtered by the kidneys, which allows for prolonged action within the circulatory system.

Pregnancy

There is limited information on the use of succinylated in pregnancy. It is essential to assess the risk versus benefit before administration.

Breast-feeding

Caution is advised when administering succinylated during breastfeeding, as its effects on nursing infants are not well-studied.

Storage

Store at room temperature, away from moisture and heat. Protect from light and 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.

This drug in other countries

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