Registered Kenya · PPB

ALBUMIN INJECTION 20% GCC

NORMAL SERUM ALBUMIN

H2016/CTD5031/757 20G/100 ML NEW/INNOVATOR

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.
H2016/CTD5031/757
Registration date
-
Expiry date
-
Status
Registered
Active ingredient
NORMAL SERUM ALBUMIN
Dosage form
20G/100 ML
Strength
-
Pack size
I VIAL PER PACKAGE
Therapeutic class
NEW/INNOVATOR
Manufacturer / MAH
Syner-med Pharmaceuticalsltd
Applicant / LTR
SYNERMED
Country of origin
FOREIGN
Manufacturer location
Gayatri House,ICD Road, Off Mombasa Road, Nairobi, Kenya

Source: Pharmacy and Poisons Board · fetched 2026-01-28 20:23:30 · updated 2026-07-26 09:22:42

Disclaimer: This information is sourced from Pharmacy and Poisons Board (Kenya). 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 normal

Normal is a medication used to treat various health conditions.

How it works

Normal works by balancing certain functions in the body to improve health.

Who it's for

Normal is suitable for individuals with specific health needs 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 serum

Serum is used to provide essential nutrients and support for various health conditions.

What it treats

  • supporting overall health
  • boosting the immune system

How it works

Serum works by delivering vital nutrients and proteins that help the body function properly.

Who it's for

Serum is suitable for individuals looking to improve their nutritional intake and support their immune health.

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: normal

Normal immunoglobulin is a preparation of immunoglobulins derived from human plasma, primarily containing IgG antibodies. It is used to provide passive immunity to individuals at risk of certain infections or those with immune deficiencies. This treatment is essential for patients who lack specific antibodies due to various medical conditions, offering immediate protection against infections.

Indications

  • Primary immunodeficiency syndromes
  • Secondary immunodeficiency
  • Immunomodulation in certain autoimmune disorders
  • Prevention of infections in patients undergoing immunosuppressive therapy

Dosage

Children: Refer to the BNF for Children for specific dosing recommendations in pediatric patients, as it varies based on age, weight, and clinical condition.

Adults: Refer to the BNF for specific dosing recommendations for adults, as it varies based on clinical indications and patient circumstances.

Mechanism of action

Normal immunoglobulin works by providing a broad spectrum of antibodies that neutralize pathogens and enhance the immune response. These antibodies bind to pathogens, facilitating their removal by immune cells and providing immediate passive immunity against infections.

Pharmacodynamics

The pharmacodynamic effects of normal immunoglobulin include the neutralization of toxins and pathogens, opsonization, and enhancement of phagocytosis. It modulates immune responses and provides immediate humoral immunity, particularly in individuals with inadequate antibody production.

Pharmacokinetics

Normal immunoglobulin is administered intravenously or subcutaneously. After administration, it is distributed throughout the body, with a half-life of approximately 21 to 30 days. It is metabolized by the reticuloendothelial system, and the rate of clearance can vary based on individual patient factors and the presence of underlying conditions.

Interactions

  • normal immunoglobulin + monoclonal antibodies: Severe (affects effects)
  • normal immunoglobulin + dinutuximab: Severe (affects effects)
  • normal immunoglobulin + live vaccines, measles, mumps and rubella vaccine, live, rotavirus vaccine, typhoid vaccine, oral, varicella-zoster vaccine: Unknown (decreases efficacy)
  • normal immunoglobulin + bacillus Calmette-Guérin vaccine: Unknown (decreases efficacy)
  • normal immunoglobulin + herpes-zoster vaccine: Unknown (decreases efficacy)
  • normal immunoglobulin + live: Unknown (decreases efficacy)
  • normal immunoglobulin + influenza vaccine, live: Unknown (decreases efficacy)

Pregnancy

Consult relevant guidelines for use in pregnancy.

Breast-feeding

Consult relevant guidelines for use during breastfeeding.

Storage

Store at 2-8°C. Do not freeze.

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: serum

Serum is a component of blood obtained after coagulation, which contains water, electrolytes, proteins, hormones, and waste products. It plays a critical role in various physiological functions, including maintaining osmotic pressure, transporting nutrients and hormones, and serving as a medium for biochemical reactions. Serum is often used in laboratory settings for diagnostic purposes, including blood tests to evaluate organ function and detect disease.

Indications

  • Diagnostic blood tests
  • Assessment of organ function
  • Evaluation of electrolyte balance
  • Monitoring of therapeutic drug levels
  • Detection of antibodies or infectious agents

Dosage

Children: Dosage is not applicable as serum is a biological fluid used for diagnostic purposes and not an administered drug.

Adults: Dosage is not applicable as serum is a biological fluid used for diagnostic purposes and not an administered drug.

Mechanism of action

Serum itself does not have a specific mechanism of action as it is a biological fluid. However, its components, particularly proteins such as albumin and immunoglobulins, contribute to homeostasis, transport, and immune response. Albumin helps in maintaining oncotic pressure and transporting various substances, while immunoglobulins play a vital role in the immune response.

Pharmacodynamics

The pharmacodynamics of serum are closely related to its composition. The proteins in serum, including enzymes, hormones, and antibodies, exert various physiological effects. For example, serum albumin helps maintain blood volume and pressure, while globulins are involved in immune function. Changes in serum composition can affect the pharmacodynamics of drugs, influencing their distribution, metabolism, and elimination.

Pharmacokinetics

Serum does not follow a traditional pharmacokinetic profile, as it is a complex mixture rather than a single drug. However, the elimination and distribution of substances within the serum can be influenced by factors such as protein binding, blood flow, and the physiological state of the individual. The half-life of any drugs or substances present in serum will depend on their specific characteristics and interactions with serum components.

Adverse effects

  • Allergic reactions
  • Infection at the injection site
  • Fever
  • Rash
  • Joint pain

Precautions

  • Use with caution in individuals with a history of allergic reactions
  • Monitor for signs of infection
  • Assess for any history of autoimmune conditions

Pregnancy

Consult healthcare provider. Safety in pregnancy is not well established.

Breast-feeding

Consult healthcare provider. Limited information is available regarding excretion in breast milk.

Storage

Store at 2 to 8 degrees Celsius. Do not freeze. Protect from light.

Formulations

  • Intravenous solution
  • Subcutaneous injection

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.