Human Normal Albumin IP 20% (Aizen Life) Technical Specification:

Product Name:Human Normal Albumin IP 20%
Brand Name:Aizen Life
Strength:5% (5gm), 20% (20gm), 25% (25gm)
Dosage Form:Liquid Injection
Packing:100ml, 50ml
Route of Administration:For I.V. use only
Pack Insert/Leaflet:PIL (Patient Information Leaflet)
Regulatory Documents:COA, MOA, Stability Studies, GMP
Therapeutic use:Volume Expanders
Indication: HUMAN ALBUMIN is used to treat blood volume loss. It works by replacing the body fluids lost due to excessive trauma, bleeding, surgery, or kidney dialysis. Thus, it is helpful in treating low blood albumin levels.
Storage:Store the container between 2°C to 25°C. Do not freeze. Protect from light.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Human Normal Albumin IP 20%

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Human Normal Albumin IP 20%
    Each vial contains:
    Total protein……………………200 g/Lit
    Sodium Caprylate…………….6.65 g/Lit
    Na+…. Not more than 160 mmol/Lit
    K+…….Not more than 2 mmol/Lit
    Aluminium……………………… ≤ 200 μg/Lit

THERAPEUTIC INDICATIONS:

HUMAN ALBUMIN is used to treat blood volume loss. It works by replacing the body fluids lost due to excessive trauma, bleeding, surgery, or kidney dialysis. Thus, it is helpful in treating low blood albumin levels.

CAUTION & WARNING:

Caution: It is dangerous to take this preparation except under medical supervision.
Warning: To be sold by retail on the prescription of the Registered Medical pharmacist only.
Active substance: human albumin
Source: Human plasma
Non-reactive for HBsAg, HCV, HIV antibodies and negative for HBV DNA, HIV RNA and HCV RNA by PCR.
Contains no preservatives.
Do not use if the solution is cloudy or turbid or if deposits have formed or if any particulate matters observed.
Contents must not be used more than four hours after the container has been penetrated and any remaining portion must be discarded.
Irrespective of blood groups, can be transferred to all recipients.
For Indication, caution, Dosage & Method of Administration please refer accompanying package insert.
Keep out of reach and sight of children.

STORAGE & DOSAGE:

Storage: Store the container between 2°C to 25°C. Do not freeze. Protect from light.
Note: shelf life of 36 months when stored at room temperature (up to +25°C)
Dosage: As directed by the physician.
For Oral use. Read the package insert before use.

Why Taj Pharmaceuticlas?

When considering a pharmaceutical company for a product like Human Normal Albumin BP, healthcare professionals and institutions assess several critical factors. Quality assurance stands as a top priority, with a focus on the company’s commitment to maintaining high standards in medication production, especially for biologics. Regulatory compliance is equally essential, ensuring that the company obtains the necessary approvals and certifications to meet strict safety and efficacy standards. The purity of products, particularly for albumin, cannot be compromised, necessitating advanced purification processes and stringent quality controls. Reliability in the supply chain and competitive pricing are also crucial to ensure a steady and cost-effective supply of Human Normal Albumin BP. Exceptional customer support, timely deliveries, and effective communication are highly valued, contributing to a positive experience for healthcare professionals and institutions. The company’s track record, reputation, and adherence to ethical business practices play a significant role in decision-making, as does a commitment to research and development for continuous improvement. Ultimately, the choice of a pharmaceutical supplier greatly influences patient care, safety, and the overall success of healthcare institutions.

What is Human Normal Albumin BP and its uses?

Human Normal Albumin BP, also known simply as albumin, refers to a sterile solution of human albumin in a specific concentration that complies with the British Pharmacopoeia (BP) standards. It is a pharmaceutical product made from human plasma and is used for various medical purposes. Here are its primary uses:

  • Plasma Volume Expander: Human Normal Albumin BP is often used as a plasma volume expander in cases of hypovolemia or shock. Hypovolemia refers to a condition where there is a significant loss of blood or other fluids, leading to a decrease in blood volume. In such situations, administering albumin helps increase blood volume and improves tissue perfusion.
  • Hypoproteinemia: Hypoproteinemia is a condition characterized by low levels of proteins, including albumin, in the blood. Human Normal Albumin BP can be used to treat this condition, especially when it is due to conditions like liver disease, kidney disease, or malnutrition.
  • Burns and Trauma: In cases of severe burns or trauma, there can be a substantial loss of fluids and proteins from the bloodstream. Human Normal Albumin BP can be administered to help restore normal blood volume and protein levels.
  • Nephrotic Syndrome: Nephrotic syndrome is a kidney disorder that can lead to the loss of proteins, including albumin, through the urine. Albumin replacement therapy may be used to manage this condition.
  • Ascites: Ascites is the accumulation of fluid in the abdominal cavity, often seen in patients with liver cirrhosis or other liver diseases. Human Normal Albumin BP can be used to manage ascites by increasing oncotic pressure in the blood vessels and reducing the accumulation of fluid in the abdomen.
  • Cardiopulmonary Bypass: During heart surgeries that require cardiopulmonary bypass, there can be a dilution of blood components. Albumin may be used to restore the blood’s colloid osmotic pressure and help maintain proper fluid balance.
  • Hemodialysis: In some cases, albumin may be used during hemodialysis to help manage complications associated with chronic kidney disease and improve blood volume and composition.

It’s important to note that the use of Human Normal Albumin BP should be determined by a qualified healthcare professional based on the patient’s specific medical condition and needs. The product is typically administered intravenously (IV) and is available in various concentrations to suit different clinical situations. Albumin is a critical component of blood plasma, and its therapeutic use can help stabilize patients in a variety of medical scenarios.

How Does Human Normal Albumin BP work?

Human Normal Albumin BP works primarily by influencing the colloid osmotic pressure within the blood vessels and interstitial spaces. Here’s how it works:

  1. Osmotic Pressure Regulation: Albumin is a protein found in the blood plasma, and it plays a crucial role in maintaining the osmotic pressure of the blood. Osmotic pressure refers to the force that draws fluid into the blood vessels from the surrounding tissues. Albumin has a high molecular weight and is a colloid, which means it contributes significantly to the colloid osmotic pressure (also known as oncotic pressure) within the bloodstream.
  2. Fluid Balance: In the circulatory system, there is a balance between hydrostatic pressure (the force pushing fluid out of blood vessels) and colloid osmotic pressure (the force pulling fluid into blood vessels). Albumin primarily contributes to the colloid osmotic pressure, which opposes the outward movement of fluids from the blood vessels into the surrounding tissues. This helps maintain the proper distribution of fluids in the body.
  3. Volume Expansion: When Human Normal Albumin BP is administered intravenously, it increases the concentration of albumin in the blood plasma. This increase in albumin concentration enhances the colloid osmotic pressure within the blood vessels. As a result, more fluid is drawn into the bloodstream from the interstitial spaces (the spaces between cells in tissues). This process leads to an expansion of the blood volume.
  4. Edema Reduction: In conditions where there is an abnormal accumulation of fluid in the interstitial spaces, such as in cases of hypovolemia, burns, or certain kidney disorders, Human Normal Albumin BP can help reduce edema (swelling) by drawing excess fluid back into the bloodstream. This helps restore normal tissue perfusion and reduces swelling.
  5. Hemodynamic Stability: Human Normal Albumin BP is also used to stabilize hemodynamics, especially during surgical procedures, cardiopulmonary bypass, and shock states. By increasing blood volume and maintaining proper colloid osmotic pressure, it helps ensure adequate tissue perfusion and organ function.

In summary, Human Normal Albumin BP works by increasing the colloid osmotic pressure in the blood, which helps regulate fluid balance, expand blood volume, reduce edema, and stabilize hemodynamics. Its therapeutic use is essential in various medical conditions to support proper fluid distribution and maintain vital organ function. However, the administration and dosage should always be determined by a healthcare professional based on the patient’s specific needs and medical condition.

Benefits and side effects of Human Normal Albumin BP:

Human Normal Albumin BP, a pharmaceutical product made from human plasma, offers several benefits and potential side effects when used for medical purposes:

Benefits:

  • Plasma Volume Expansion: Human Normal Albumin BP is a valuable tool for increasing blood volume in cases of hypovolemia (low blood volume) due to trauma, surgery, or other medical conditions. It helps restore adequate blood circulation and tissue perfusion.
  • Oncotic Pressure Restoration: Albumin is a crucial component of blood plasma that helps maintain colloid osmotic pressure. By administering Human Normal Albumin BP, oncotic pressure can be restored, preventing the loss of fluids from blood vessels into surrounding tissues.
  • Edema Reduction: In conditions where there is excessive fluid accumulation in tissues (edema), such as in cases of ascites or nephrotic syndrome, Human Normal Albumin BP can help reduce edema by drawing excess fluid back into the bloodstream.
  • Hemodynamic Stabilization: The expansion of blood volume through albumin administration can contribute to hemodynamic stability, particularly during surgeries, cardiopulmonary bypass procedures, and shock states. It helps maintain blood pressure and organ perfusion.
  • Hypoproteinemia Management: For patients with low levels of proteins, including albumin, Human Normal Albumin BP can be used to manage conditions like hypoproteinemia due to liver or kidney disease or malnutrition.

Side Effects:

  • Allergic Reactions: As with any blood-derived product, there is a risk of allergic reactions, although they are rare. Symptoms can range from mild skin reactions to severe anaphylaxis. Healthcare providers closely monitor patients during albumin administration to address any potential allergic responses.
  • Volume Overload: In some cases, the rapid infusion of Human Normal Albumin BP can lead to volume overload, causing fluid accumulation in the lungs (pulmonary edema) or other tissues. Careful dosing and monitoring are essential to prevent this complication.
  • Transmission of Infections: While rigorous screening and processing procedures are in place to reduce the risk, there is a minimal risk of transmitting infectious agents through blood-derived products like Human Normal Albumin BP.
  • Coagulation Abnormalities: In rare cases, the administration of albumin may cause coagulation abnormalities. This can manifest as bleeding or clotting issues. Monitoring of coagulation parameters is advisable, especially in patients with preexisting clotting disorders.
  • Electrolyte Imbalances: Albumin administration can influence electrolyte balance, particularly sodium levels. This can result in hypo- or hypernatremia, potentially leading to symptoms such as neurological disturbances or fluid imbalances.

It’s important to recognize that the benefits of Human Normal Albumin BP often outweigh the potential risks, especially when used under the supervision of healthcare professionals who carefully assess the patient’s condition and administer the product according to established protocols. Patient safety is a top priority, and any side effects or adverse reactions are promptly addressed by healthcare providers.

Frequently Asked Questions About Human Normal Albumin BP:

Certainly, here are some frequently asked questions (FAQs) about Human Normal Albumin BP:

  1. What is Human Normal Albumin BP?

Human Normal Albumin BP refers to a sterile solution of human albumin that complies with the British Pharmacopoeia (BP) standards. It is derived from human plasma and is used for various medical purposes.

  1. What is the primary function of Human Normal Albumin BP?

The primary function of Human Normal Albumin BP is to increase blood volume and maintain colloid osmotic pressure. It is used in conditions where there is a need to expand blood volume, restore fluid balance, or manage edema.

  1. In which medical situations is Human Normal Albumin BP commonly used?

Human Normal Albumin BP is commonly used in cases of hypovolemia (low blood volume), burns, trauma, ascites, nephrotic syndrome, and during certain surgical procedures to stabilize hemodynamics.

  1. How is Human Normal Albumin BP administered?

Human Normal Albumin BP is typically administered intravenously (IV) by healthcare professionals. The dosage and rate of administration are determined based on the patient’s condition and the clinical situation.

  1. Are there any contraindications or situations where Human Normal Albumin BP should not be used?

Yes, there are contraindications and precautions. It should be used with caution in patients with known allergies to albumin or any components of the product. Patients with certain medical conditions, such as congestive heart failure or severe pulmonary edema, may also require careful evaluation before administration.

  1. What are the potential side effects of Human Normal Albumin BP?

Potential side effects can include allergic reactions, volume overload, transmission of infections (though rare), coagulation abnormalities, and electrolyte imbalances. These risks are closely monitored by healthcare providers during administration.

  1. How is the safety of Human Normal Albumin BP ensured?

The safety of Human Normal Albumin BP is ensured through rigorous screening and processing of plasma donors, as well as adherence to strict quality control and safety standards during manufacturing. Regulatory authorities also oversee the production and distribution of albumin products.

  1. Is Human Normal Albumin BP compatible with other medications or fluids?

Compatibility with other medications and fluids depends on the specific drugs or solutions involved. Healthcare professionals assess compatibility based on the patient’s treatment plan.

  1. Can Human Normal Albumin BP be used during pregnancy and breastfeeding?

The use of Human Normal Albumin BP during pregnancy and breastfeeding should be carefully considered and determined by a healthcare provider based on the patient’s specific medical condition and needs.

  1. What is the shelf life of Human Normal Albumin BP, and how should it be stored?

The shelf life and storage instructions for Human Normal Albumin BP can vary by manufacturer and product formulation. Healthcare providers follow the manufacturer’s guidelines to ensure product integrity and safety.

Always consult with a qualified healthcare provider for personalized information and guidance regarding the use of Human Normal Albumin BP, as individual circumstances and medical needs may vary.

As Human Normal Albumin BP Exporters; We can cater to export business queries from the following geographies. We are exporting our Human Normal Albumin BP product in the Following Countries-

Russia and CIS Countries: Azerbaijan, Armenia, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Russia, Tajikistan, Turkmenistan, Uzbekistan and Ukraine

GCC/ Middle East Countries: Saudi Arabia, Yemen, Oman, Bahrain, UAE, Lebanon, Jordan, and Iraq.

African Countries: Nigeria, Tanzania, Sudan, Zambia, Benin, Angola, Liberia

Southeast Asia: Cambodia, Indonesia, Laos, Malaysia, Myanmar, Philippines, Singapore, Thailand, Vietnam, Brunei Darussalam

Other Asian Countries: Nepal, Myanmar, Malaysia, Cambodia, Bhutan, Sri Lanka, Mauritius

Human Normal Albumin BP Regulatory Documents:

  • Certificate of Analysis (COA)
  • Method of Analysis (MOA)
  • Stability Data (Accelerated stability / Long-term stability / Zone 4b)
  • CTD Dossier / ACTD Dossiers / eCTD Dossiers
  • Certificate of Pharmaceuticals Product (COPP)
  • Free Sale Certificate (FSC)
Contact the most reliable manufacturer of Human Normal Albumin BP, Taj Pharmaceuticals Limited, to get bulk quantities at a reasonable price.

To Place Orders:

Direct line: +91 8448 444 095 / WhatsApp +91 74 0000 9975 / 74 0000 9976
E-Mail: info@tajpharma.com 
Toll free: 1-800-222-434 / Toll free: 1-800-222-825
General EPA BX: +91 22 2637 4592 / +91 22 2637 4593
Fax No: +91 22 2634 1274

GENERIC NAME OF THE MEDICINAL PRODUCT:

a) Human Normal Albumin IP 5%
b) Human Normal Albumin IP 20%
c) Human Normal Albumin IP 25%

QUALITATIVE AND QUANTITATIVE COMPOSITION:

a) Human Normal Albumin IP 5%
Each vial contains:
Total protein……………………50 g/Lit
Sodium Caprylate…………….1.66 g/Lit
Na+…. Not more than 160 mmol/Lit
K+...….Not more than 2 mmol/Lit
Aluminium……………………… ≤ 200 μg/Lit

b) Human Normal Albumin IP 20%
Each vial contains:
Total protein……………………200 g/Lit
Sodium Caprylate…………….6.65 g/Lit
Na+…. Not more than 160 mmol/Lit
K+...….Not more than 2 mmol/Lit
Aluminium……………………… ≤ 200 μg/Lit

c) Human Normal Albumin IP 25%
Each vial contains:
Total protein……………………250 g/Lit
Sodium Caprylate…………….8.3 g/Lit
Na+…. Not more than 160 mmol/Lit
K+...….Not more than 2 mmol/Lit
Aluminium……………………… ≤ 200 μg/Lit

THERAPEUTIC INDICATIONS:

HUMAN ALBUMIN is used to treat blood volume loss. It works by replacing the body fluids lost due to excessive trauma, bleeding, surgery, or kidney dialysis. Thus, it is helpful in treating low blood albumin levels.

CAUTION & WARNING:

Caution: It is dangerous to take this preparation except under medical supervision.
Warning: To be sold by retail on the prescription of the Registered Medical pharmacist only.
Active substance: human albumin
Source: Human plasma
Non-reactive for HBsAg, HCV, HIV antibodies and negative for HBV DNA, HIV RNA and HCV RNA by PCR.
Contains no preservatives.
Do not use if the solution is cloudy or turbid or if deposits have formed or if any particulate matters observed.
Contents must not be used more than four hours after the container has been penetrated and any remaining portion must be discarded.
Irrespective of blood groups, can be transferred to all recipients.
For Indication, caution, Dosage & Method of Administration please refer accompanying package insert.
Keep out of reach and sight of children.

STORAGE & DOSAGE:

Storage: Store the container between 2°C to 25°C. Do not freeze. Protect from light.
Note: shelf life of 36 months when stored at room temperature (up to +25°C)
Dosage: As directed by the physician.
For Oral use. Read the package insert before use.