Registered Zambia · ZAMRA

Alburel Injection (Human Albumin 20%)

Human Albumin Solution BP 20% Total Protein 20% IU/2ml

ZAMRA-HM-22-11 Solution for infusion 20% IU/2ml

What it does

Albumin is a protein found in blood that helps maintain fluid balance and transport substances in the body.

Commonly used for: low protein levels in blood (hypoalbuminemia), liver disease, kidney disease, burns …

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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.
ZAMRA-HM-22-11
Registration date
2022-02-23
Expiry date
2027-02-22
Status
Registered/Compliant
Active ingredient
Human Albumin Solution BP 20% Total Protein 20% IU/2ml
Dosage form
Solution for infusion
Strength
20% IU/2ml
Pack size
-
Therapeutic class
-
Manufacturer / MAH
Reliance Life Sciences
Country of origin
India
Manufacturer location
5R3J+H2F, Dindori, Akrale, Maharashtra 422004, India

Source: Zambia Medicines Regulatory Authority · fetched 2026-03-12 00:01:24 · updated 2026-10-19 03:32:53

Disclaimer: This information is sourced from Zambia Medicines Regulatory Authority (Zambia). Always consult a qualified healthcare professional before using any medication.

About albumin

Albumin is a protein found in blood that helps maintain fluid balance and transport substances in the body.

What it treats

  • low protein levels in blood (hypoalbuminemia)
  • liver disease
  • kidney disease
  • burns
  • surgery

How it works

Albumin helps to keep fluid in the bloodstream and prevents it from leaking into other tissues.

Who it's for

This treatment is for patients who have low levels of albumin due to various medical conditions.

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

About human

Human is a term that generally refers to a member of the species Homo sapiens, and in the context of medicine, it may relate to various human-derived products or treatments. However, there are no specific drug class, interactions, or cautions provided for this entry.

How it works

There is no specific information on how this ingredient works as it may relate to various contexts within human health.

Who it's for

Information regarding specific patients or conditions is not provided.

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

About protein

Protein is an essential nutrient that helps build and repair tissues in the body.

What it treats

  • malnutrition
  • muscle weakness
  • wound healing

How it works

Protein provides the building blocks (amino acids) that the body needs to create and maintain muscles, skin, and other tissues.

Who it's for

It is suitable for anyone who needs to increase their protein intake, including those recovering from illness or injury, athletes, and people with certain dietary restrictions.

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

About total

Total is a medication that is commonly used to treat a variety of health conditions, although specific details about its drug class, interactions, and cautions are not provided.

How it works

Total works in the body to help manage certain health conditions.

Who it's for

Total is suitable for individuals with specific health conditions 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.

Clinical monograph: albumin

Albumin is a plasma protein synthesized primarily in the liver, playing a crucial role in maintaining oncotic pressure and transporting various substances in the blood, including hormones, vitamins, and drugs. It is used therapeutically to expand blood volume in conditions such as hypoalbuminemia, shock, and liver cirrhosis. The use of albumin in clinical practice is vital for managing patients who require volume resuscitation or have low protein levels due to liver disease or nephrotic syndrome.

Indications

  • Hypoalbuminemia
  • Volume resuscitation in shock
  • Liver cirrhosis
  • Nephrotic syndrome
  • Burns
  • Postoperative fluid management

Dosage

Children: Refer to the BNF for Children for specific dosing recommendations based on clinical condition and patient response.

Adults: Refer to the appropriate guidelines for specific dosing recommendations based on clinical condition and patient response.

Mechanism of action

Albumin acts by maintaining oncotic pressure in the vascular system, thus preventing fluid from leaking into tissues and promoting the return of interstitial fluid to the bloodstream. This action helps restore blood volume and improve circulation in patients with conditions that lead to hypovolemia or edema. Additionally, albumin can bind and transport various endogenous and exogenous substances, influencing their distribution and elimination.

Pharmacodynamics

The primary pharmacodynamic effect of albumin is the increase in plasma oncotic pressure, which helps to retain fluid within the vascular space. This effect is critical in managing conditions associated with fluid imbalance. Albumin also has antioxidant properties and may play a role in modulating inflammatory responses, although these effects are secondary to its role in volume expansion.

Pharmacokinetics

Albumin is administered intravenously, where it is distributed rapidly throughout the vascular compartment. The half-life of albumin in circulation is typically around 15 to 20 days, depending on physiological conditions. It is metabolized primarily in the liver, with a small percentage undergoing renal clearance. The distribution volume is influenced by factors such as hydration status and the presence of diseases affecting protein levels.

Contra-indications

  • Severe anemia
  • Congestive heart failure
  • Pulmonary edema
  • Severe dehydration
  • Allergy to albumin or any component of the formulation

Adverse effects

  • Allergic reactions including anaphylaxis
  • Headache
  • Nausea
  • Vomiting
  • Fever
  • Hypotension
  • Fluid overload

Interactions

  • Caution should be exercised when administering with other fluids or medications that may affect fluid balance
  • May alter the pharmacokinetics of certain drugs due to changes in plasma volume

Precautions

  • Monitor for signs of fluid overload, especially in patients with heart or kidney disease
  • Use cautiously in patients with a history of allergic reactions
  • Ensure proper storage and handling to avoid contamination

Pregnancy

Albumin is generally considered safe during pregnancy when administered for appropriate indications, but its use should be assessed on a case-by-case basis.

Breast-feeding

Albumin can be used during breastfeeding, as it is a naturally occurring protein in human milk.

Storage

Store at 2 to 8 degrees Celsius. Do not freeze. Protect from light and use within the expiry date.

Formulations

  • Human albumin solution (various concentrations)
  • Albumin (500 mL bags, 20% and 5% solutions)

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: human

Human refers to the species Homo sapiens, which is characterized by advanced cognitive abilities, social structures, and the capability for complex communication. The term may also refer to human-derived biological products, such as blood, tissues, or organs used in medical treatments and research.

Dosage

Children: Dosage for human-derived biological products in pediatrics should be determined based on specific product guidelines and the clinical context.

Adults: Dosage for human-derived biological products varies widely. Refer to specific product information for appropriate dosing.

Mechanism of action

Human physiology is governed by complex biological systems involving various cellular and molecular pathways. The mechanisms of action for human-derived biological products vary widely depending on the specific context, including immune response, hormonal regulation, and metabolic processes.

Pharmacodynamics

Pharmacodynamics in humans involves the interaction of drugs with biological systems, resulting in therapeutic effects. This includes receptor binding, signal transduction, and physiological responses. The effects are influenced by genetic factors, existing health conditions, and concurrent medications.

Pharmacokinetics

Pharmacokinetics in humans involves the absorption, distribution, metabolism, and excretion (ADME) of substances. Factors such as age, sex, body weight, and organ function can significantly influence these processes. Drug absorption may occur via oral, intravenous, or other routes, while distribution depends on blood flow and tissue permeability. Metabolism typically occurs in the liver, and excretion primarily takes place through the kidneys.

Pregnancy

There is no specific information available; consult local guidelines.

Breast-feeding

There is no specific information available; consult local guidelines.

Storage

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

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: protein

Proteins are large, complex molecules made up of amino acids and are essential for the structure, function, and regulation of the body's tissues and organs. They play critical roles in various biological processes, including enzymatic reactions, immune responses, and cellular signaling. Dietary proteins are obtained from both animal and plant sources and are broken down into amino acids during digestion, which are then used by the body to synthesize new proteins as needed.

Indications

  • Nutritional supplementation
  • Muscle repair and growth
  • Immune support
  • Enzyme replacement therapy
  • Hormonal regulation

Dosage

Children: Refer to specific product guidelines for dosing information, as protein requirements in children vary based on age, growth stage, and health status.

Adults: Refer to specific product guidelines for dosing information, as protein requirements can vary widely based on individual needs, activity levels, and clinical conditions.

Mechanism of action

Proteins exert their effects primarily through their structure and interactions with other molecules. They can function as enzymes, hormones, and antibodies, and their action is often mediated by binding to specific receptors or substrates, leading to a change in cellular activity or function. For example, enzymes catalyze biochemical reactions, while antibodies bind to antigens to facilitate immune responses.

Pharmacodynamics

The pharmacodynamics of proteins can vary significantly depending on the specific protein being considered. Generally, the effects of proteins are dose-dependent and influenced by their concentration, affinity for targets, and duration of action. Proteins can have a wide range of biological activities, including promoting cellular repair, regulating metabolism, and modulating immune responses.

Pharmacokinetics

The pharmacokinetics of proteins includes their absorption, distribution, metabolism, and excretion (ADME). Proteins are typically digested in the gastrointestinal tract into amino acids before being absorbed into the bloodstream. Once in circulation, proteins can be distributed throughout various tissues. They may have a variable half-life based on their structure and function, and they are primarily metabolized by the liver and excreted via the kidneys. The pharmacokinetic profile can be influenced by factors such as the route of administration and the presence of other substances.

Pregnancy

Generally considered safe, but high protein intake should be monitored to avoid potential risks.

Breast-feeding

Adequate protein intake is critical for lactating women to support milk production and quality.

Storage

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

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: total

Total is a term that can refer to various medications or substances depending on the context. Without specific information regarding the active ingredient or therapeutic category, a comprehensive drug monograph cannot be accurately compiled. However, the term might be associated with nutritional supplements, total parenteral nutrition, or other specific drug formulations.

Dosage

Children: Paediatric dosing should also be determined based on the specific formulation and clinical context. Refer to appropriate paediatric guidelines.

Adults: Dosage would depend on the specific formulation and clinical scenario. Refer to established guidelines for specific dosing.

Mechanism of action

The mechanism of action would depend on the specific formulation or active ingredients referred to as 'total'. For example, in the context of total parenteral nutrition, it provides essential nutrients (carbohydrates, proteins, fats, vitamins, and minerals) directly into the bloodstream, bypassing the gastrointestinal tract.

Pharmacodynamics

Pharmacodynamics would vary widely based on the specific active ingredients within the formulation. In the case of total parenteral nutrition, its pharmacodynamics involve the absorption of macronutrients and micronutrients into the body for metabolic processes.

Pharmacokinetics

Pharmacokinetics would also vary based on the specific components. For example, when discussing total parenteral nutrition, the components are absorbed into the bloodstream, metabolized by the liver, and utilized by various tissues in the body. The elimination of waste products occurs primarily through the kidneys.

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.