GENERIC NAME OF THE MEDICINAL PRODUCT:

Human Normal Albumin I.P. 20%

QUALITATIVE AND QUANTITATIVE COMPOSITION:

Human Normal Albumin I.P. 20%
Composition:
Each 100ml bottle contains:
Total Protein ………………...200 g/Lit
Sodium Caprylate…………6.65 g/Lit
Na+ ……. Not more than 160mmol/Lit
K+………... Not more than 2mmol/Lit
Albumin ……………………. 200 μg/Lit
Contains no preservatives.

THERAPEUTIC INDICATIONS:

Human Normal Albumin solution is used to treat acute liver failure because of its ability to bind excess bilirubin (a substance produced by liver) and increase the volume of blood.

DIRECTION OF USE:

For IV use.
See insert for detailed dosage, directions for use and precautions.

CAUTION AND SCHEDULE:

CAUTION: The injection should be discard if any visible particles appears.
*Treatment of Primary Immunodeficiency.
*Manufactured from qualified human plasma.
Do not use the solution is turbid.
SCHEDULE: Not to be sold by retail without the prescription of Registered Medical Practitioner.
Discard Unused portion.
Keep medicine out of reach of children.

STORAGE & DOSAGE:

Storage: Store the bottle in its original cartoon between 25°C.
Do not freeze.
Shelf life: Stable for 3 years when stored at recommended storage conditions.
Dosage: As directed by physician.
Source: Human plasma non-reactive for HBsAg, HCV, HIV 1&2 antibodies and negative for HIV 1&2, HCV, HBV by NAT, RNA & PCR.

Human Normal Albumin I.P. 20% Technical Specification:

Product Name:Human Normal Albumin I.P.
(Solution of Human Advanced Protein)
Brand Name:Aizenlife
Strength:20%
Dosage Form:Liquid Injection (Bottle)
Packing:50 mL, 100 mL
Route of Administration:For IV use
Pack Insert/Leaflet:PIL (Patient Information Leaflet)
Regulatory Documents:COA, MOA, Stability Studies, GMP
Therapeutic use:Volume Expanders
Indication: Human Normal Albumin solution is used to treat acute liver failure because of its ability to bind excess bilirubin (a substance produced by liver) and increase the volume of blood.
Storage:Store the bottle in its original cartoon between 25°C. Do not freeze.
Shelf life: Stable for 3 years when stored at recommended storage conditions.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Human Normal Albumin I.P. 20%

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Human Normal Albumin I.P. 20%
    Composition:
    Each 100ml bottle contains:
    Total Protein …………………200 g/Lit
    Sodium Caprylate…………6.65 g/Lit
    Na+ ……. Not more than 160mmol/Lit
    K+………… Not more than 2mmol/Lit
    Albumin ……………………. 200 μg/Lit
    Contains no preservatives.

THERAPEUTIC INDICATION:

Human Normal Albumin solution is used to treat acute liver failure because of its ability to bind excess bilirubin (a substance produced by liver) and increase the volume of blood.

DIRECTION OF USE:

For IV use.
See insert for detailed dosage, directions for use and precautions.

CAUTION & schedule:

CAUTION:
The injection should be discard if any visible particles appears.
Treatment of Primary Immunodeficiency.
Manufactured from qualified human plasma.
Do not use the solution is turbid.

Schedule:  Not to be sold by retail without the prescription of Registered Medical Practitioner.
Discard Unused portion.
Keep medicine out of reach of children.

STORAGE & DOSAGE:

Storage:  Store the bottle in its original cartoon between 25°C. Do not freeze.
Shelf life: Stable for 3 years when stored at recommended storage conditions.

Dosage:  As directed by physician.

Source: Human plasma non-reactive for HBsAg, HCV, HIV 1&2 antibodies and negative for HIV 1&2, HCV, HBV by NAT, RNA & PCR.

Why Taj Pharmaceuticals?

The key reasons why Taj Pharma is your trusted choice for Human Normal Albumin I.P. Unparalleled quality, reliability, and commitment to healthcare excellence. When it comes to your healthcare needs, Taj Pharma’s dedication to quality assurance, stringent manufacturing standards, and a legacy of pharmaceutical expertise make us the preferred supplier for Human Normal Albumin I.P. At Taj Pharma, quality is at the core of everything we do. Our Human Normal Albumin I.P. undergoes rigorous quality control measures to ensure purity and safety. We adhere to international pharmacopeial standards, and our state-of-the-art manufacturing facilities are equipped with cutting-edge technology, ensuring consistency in every batch.

Reliability is another pillar of our reputation. Taj Pharma has a track record of supplying healthcare professionals and institutions with top-quality pharmaceutical products, including Human Normal Albumin I.P., for decades. You can rely on us for consistent and timely deliveries, enabling you to meet your patients’ needs with confidence. Our commitment to healthcare excellence extends beyond just providing products. Taj Pharma believes in fostering a healthier world, and our Human Normal Albumin I.P. reflects that commitment. It plays a crucial role in various medical treatments, including critical care situations. When you choose Taj Pharma, you choose a partner dedicated to advancing healthcare and improving patient outcomes.

Taj Pharma is your trusted source for Human Normal Albumin I.P., offering unparalleled quality, reliability, and an unwavering commitment to healthcare excellence. Make the right choice for your patients and healthcare institution by choosing Taj Pharma.

What is Human Normal Albumin I.P. and its use?

Human Normal Albumin I.P., or Human Serum Albumin, is a sterile, clear, and colorless liquid derived from human blood plasma. It is a highly purified form of serum albumin, a protein found in human blood. This pharmaceutical product is processed to meet specific quality and safety standards outlined in the Indian Pharmacopoeia (I.P.) and other relevant regulatory guidelines.

The primary use of Human Normal Albumin I.P. is in the medical field, where it serves several important purposes:

  • Volume Expander: Human Normal Albumin I.P. is commonly used to increase blood volume in patients who have experienced significant blood loss due to trauma, surgery, or other medical conditions. It helps to restore and maintain blood pressure, ensuring adequate tissue perfusion and oxygen delivery.
  • Plasma Protein Replacement: In certain medical conditions, such as liver disease or severe burns, patients may have reduced levels of albumin in their blood. Human Normal Albumin I.P. can be administered to replace these lost proteins, improving overall health and aiding in recovery.
  • Transport of Medications: Albumin is known for its ability to bind to various drugs and substances in the blood. This property is utilized to transport and deliver medications, especially those with low solubility or that require protection from rapid degradation.
  • Treatment of Ascites: In patients with liver cirrhosis, albumin is sometimes used to manage ascites, a buildup of fluid in the abdominal cavity. It helps to maintain the body’s fluid balance and reduce the accumulation of ascitic fluid.
  • Critical Care: Human Normal Albumin I.P. is often used in critical care settings, such as intensive care units, to stabilize patients with severe conditions, including sepsis, shock, and acute respiratory distress syndrome (ARDS).
  • Hypoproteinemia: It can be prescribed to individuals with hypoproteinemia, a condition characterized by abnormally low levels of proteins in the blood, including albumin. This helps address symptoms like edema (swelling) and fluid retention.

How does Human Normal Albumin I.P. work?

Human Normal Albumin I.P. (Human Serum Albumin) works in the body through several important mechanisms:

  • Volume Expansion: One of the primary functions of Human Normal Albumin I.P. is to increase blood volume when it is administered intravenously. This is especially important in situations where a patient has experienced significant blood loss due to surgery, trauma, or other medical conditions. By increasing blood volume, it helps to restore and maintain blood pressure, ensuring that vital organs receive an adequate supply of oxygen and nutrients.
  • Oncotic Pressure: Albumin is a major contributor to the oncotic pressure of blood, also known as colloid osmotic pressure. This pressure is essential for maintaining the balance of fluids between the blood vessels and surrounding tissues. Human Normal Albumin I.P. helps to keep fluid within the blood vessels, preventing excessive fluid leakage into tissues (edema). This is particularly relevant in conditions where oncotic pressure is reduced, such as in liver disease or severe burns.
  • Transport of Molecules: Albumin has a unique binding capacity for various molecules, including drugs, hormones, and fatty acids. This property allows it to transport these substances in the bloodstream, helping to deliver them to their target tissues. For example, albumin can transport medications that have low solubility or that need protection from rapid degradation.
  • Buffering pH: Albumin can act as a buffer in the blood, helping to maintain the body’s pH balance. It can bind to both acidic and basic compounds, helping to stabilize the blood’s pH level within the narrow physiological range necessary for normal bodily functions.
  • Stabilizing Blood Pressure: In conditions like sepsis or shock, where blood pressure can drop dramatically, Human Normal Albumin I.P. can be administered to help stabilize blood pressure and improve perfusion of vital organs.
  • Treating Ascites: In individuals with liver cirrhosis and ascites (abdominal fluid accumulation), albumin can help manage the condition by increasing oncotic pressure and reducing the accumulation of fluid in the abdominal cavity.

Overall, Human Normal Albumin I.P. plays a crucial role in maintaining the balance of fluids and solutes in the bloodstream, transporting important molecules, and ensuring proper tissue perfusion. Its therapeutic use is carefully determined based on the specific medical condition and needs of the patient, and it is administered under medical supervision to achieve the desired clinical outcomes.

Benefits of Human Normal Albumin IP:

  • Volume Expansion: Human Normal Albumin I.P. is an effective volume expander, helping to restore and maintain blood volume in situations of blood loss due to surgery, trauma, or medical conditions. This can be life-saving in critical situations.
  • Oncotic Pressure Restoration: It helps restore oncotic pressure, preventing excessive fluid leakage from blood vessels into surrounding tissues. This is especially beneficial in conditions like liver disease and severe burns.
  • Medication Transport: Albumin’s ability to bind to various molecules allows it to transport drugs and other substances in the blood, facilitating their delivery to target tissues.
  • pH Regulation: It acts as a buffer in the blood, helping to maintain the body’s pH balance within a narrow physiological range.
  • Stabilizing Blood Pressure: In cases of severe hypotension (low blood pressure), Human Normal Albumin I.P. can help stabilize blood pressure, improving perfusion to vital organs.
  • Management of Ascites: It can be used to manage ascites in individuals with liver cirrhosis, reducing abdominal fluid accumulation and associated symptoms.

Side Effects of Human Normal Albumin IP:

While Human Normal Albumin I.P. is generally considered safe when used appropriately, it can have some potential side effects, especially when administered inappropriately or in high doses:

  • Hypersensitivity Reactions: Some individuals may experience allergic reactions, including rash, itching, swelling, or difficulty breathing, when administered with Human Normal Albumin I.P. These reactions are rare but can be severe in some cases.
  • Fluid Overload: Inappropriate or excessive administration of albumin can lead to fluid overload, causing symptoms such as edema (swelling), increased blood pressure, and congestive heart failure. Proper dosage and monitoring are crucial to avoid this side effect.
  • Transmission of Infections: While stringent safety measures are in place to reduce the risk, there is still a theoretical risk of transmitting infectious agents through blood-derived products like Human Normal Albumin I.P. These risks are minimized through donor screening and advanced manufacturing processes.
  • Coagulation Abnormalities: In rare cases, Human Normal Albumin I.P. may interfere with blood clotting mechanisms, potentially increasing the risk of bleeding.
  • Electrolyte Imbalance: Large volumes of albumin can affect electrolyte balance in the blood, particularly calcium levels, leading to hypocalcemia (low calcium levels).
  • Headache and Nausea: Some individuals may experience mild side effects such as headache, nausea, or fever.

Frequently asked questions about Human Normal Albumin I.P.

  1. What is Human Normal Albumin I.P. used for?

Human Normal Albumin I.P. is used to increase blood volume, manage conditions with low albumin levels, transport medications, stabilize blood pressure, and treat ascites, among other medical purposes.

  1. How is Human Normal Albumin I.P. administered?

It is typically administered intravenously (IV) under medical supervision. The dosage and rate of administration depend on the patient’s condition and specific medical needs.

  1. Is Human Normal Albumin I.P. safe?

When used appropriately, Human Normal Albumin I.P. is considered safe. However, like any medication, it can have side effects, and its use should be closely monitored by healthcare professionals.

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

Common side effects include hypersensitivity reactions, fluid overload, and electrolyte imbalances. Serious side effects are rare but can occur.

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

Its use during pregnancy and breastfeeding should be carefully considered, and the benefits should outweigh the potential risks. Consult with a healthcare provider for guidance.

  1. Is Human Normal Albumin I.P. derived from human blood?

Yes, Human Normal Albumin I.P. is derived from human blood plasma through a process that involves purification and safety measures to minimize the risk of infection transmission.

  1. Can it be used for pediatric patients and infants?

Yes, it can be used for pediatric patients and infants when medically necessary, but dosing and administration should be adjusted according to the child’s age, weight, and clinical condition.

  1. How is Human Normal Albumin I.P. different from other albumin products?

Human Normal Albumin I.P. meets specific quality and safety standards outlined in the Indian Pharmacopoeia (I.P.) and other regulatory guidelines. It is produced with a focus on adherence to these standards.

  1. Can it be stored at home for emergencies?

No, Human Normal Albumin I.P. should be stored and administered in a controlled healthcare setting by trained medical professionals. It is not intended for home use.

  1. How long is Human Normal Albumin I.P. typically administered?

The duration of administration varies depending on the patient’s condition. It may be a single dose or administered over several days, as determined by the treating physician.

As Human Normal Albumin I.P. Exporters; We can cater to export business queries from the following geographies. We are exporting our Human Normal Albumin I.P. 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 I.P. 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 IP, 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