VI-ALB (HUMAN NORMAL ALBUMIN BP 20%)

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)

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.

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.