GENERIC NAME OF THE MEDICINAL PRODUCT:

A) Human Albumin Solution BP 20%(20gm/10ml)
B)Human Albumin Solution BP 20%(10gm/50ml)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Human Albumin Solution BP 20% (20gm/100ml)
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

(B) Human Albumin Solution BP 20%(10gm/50ml)
Each vial contains:
Total protein……………………200 g/Lit
Sodium Caprylate…………….16 mmol/l
N-Acetyl-DL-Tryptophanate……3.94gm(16mmol/l)
Na+…. …………125 mmol/Lit
K+...…. Not more than 2 mmol/Lit
Aluminium……………………… ≤ 200 μg/Lit

THERAPEUTIC INDICATIONS:

Human Albumin Solution BP 20% 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.

QUALIFIED HUMAN PLASMA:

Qualified Human Plasma is the pure form of human plasma that does not contain  HIV virus in it. it has passed all the necessary test mentioned in national institute of Biologics.

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 24 months when stored at room temperature (up to 25°C)
Dosage: As directed by the physician.
Read the package insert before use.

Human Albumin Solution BP 20% (Aizen Life) Technical Specification:

Product Name:Human Albumin Solution BP 20%
Brand Name:Aizen Life
Strength: 20%(20gm/100ml), 20%(10gm/50ml)
Dosage Form:Liquid Injection
Packing:100ml, 50ml
Plasma Origin:Indian Origin
Qualified Plasma:Our Product is derived from Qualified Human Plasma (Indian Origin) and it is Non-reactive For HBsAG, HCV, HIV-1 & HIV-2 Antibodies and Negative for HBV DNA, HIV RNA and HCV RNA by PCR.
Route of Administration:For I.V. use only
Pack Insert/Leaflet:PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents:COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Test Certificate: Non-reactive For HBsAG, HCV, HIV-1 & HIV-2 Antibodies and Negative for HBV DNA, HIV RNA and HCV RNA by PCR.
Therapeutic use:Volume Expanders
Indication: Human Albumin Solution BP 20% Infusion 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.

Human Albumin Injection BP 20% Infusion I.V. Manufacturers & Exporters in PAN India and Overseas

Taj Pharmaceuticals is acclaimed as one of the leading manufacturers of Human Albumin Solution BP 20% (20gm/100ml) in India and exporter in PAN India and overseas. It is available in two different strengths with us that are 20% (20gm/100ml) and 20%(10gm/50ml). The Injection is manufactured according to the set guidelines of the regulatory bodies and thus is safe to in use. This Plasma Derivative is used to treatment of low blood volume (hypovolemia) and It enters your bloodstream and helps keep fluid from leaking out of your blood vessels into other tissues. It also carries hormones, vitamins, and enzymes throughout your body. Without enough albumin, fluid can leak out of your blood and build up in your lungs, abdomen (belly), or other parts of your body. These proteins are found in the blood.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Human Albumin Solution BP 20% (20gm/100ml)
  • Human Albumin Solution BP 20% (10gm/50ml)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Human Albumin Solution BP 20% (20gm/100ml)
    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
  • Human Albumin Solution BP 20% (10gm/50ml)
    Each vial contains:
    Total protein……………………200 g/Lit
    Sodium Caprylate…………….16 mmol/l
    N-Acetyl-DL-Tryptophanate……3.94gm(16mmol/l)
    Na+….…………125 mmol/Lit
    K+……. Not more than 2 mmol/Lit
    Aluminium……………………… ≤ 200 μg/Lit

THERAPEUTIC INDICATIONS:

Human Albumin Solution BP 20% 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.

QUALIFIED HUMAN PLASMA:

Qualified Human Plasma is the pure form of human plasma that does not contain the HIV virus in it. it has passed all the necessary tests mentioned in the National Institute of Biologics.

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 2°C to 25°C)
Dosage: As directed by the physician.
Read the package insert before use.

Why Taj Pharmaceuticals?

Taj Pharmaceuticals is the preferred choice for Human Albumin Solution BP, and several key factors set them apart in the pharmaceutical industry. With an unwavering commitment to quality, Taj Pharmaceuticals is renowned for ensuring the safety and effectiveness of its pharmaceutical products. Their extensive experience, spanning decades in the field, translates into an in-depth understanding of pharmaceuticals and the ability to cater to the diverse needs of healthcare professionals and patients alike. Taj Pharmaceuticals operates state-of-the-art manufacturing facilities, including their prominent Taj Pharma plant in Vapi, Gujarat. These facilities adhere to stringent quality control measures, ensuring the precise and consistent production of Human Albumin Solution BP. This dedication to quality and consistency is at the core of Taj Pharmaceuticals’ mission, underlining its commitment to delivering pharmaceutical solutions that healthcare providers and patients can rely on.

Taj Pharmaceuticals extends its reach beyond India, functioning as a trusted exporter from India. This global presence means that their high-quality pharmaceutical solutions, including Human Albumin Solution BP, are accessible to a worldwide audience. Taj Pharmaceuticals’ dedication to improving healthcare transcends borders, making a positive impact on a global scale. Taj Pharmaceuticals is distinguished in the pharmaceutical industry by its steadfast commitment to quality, extensive pharmaceutical expertise, state-of-the-art manufacturing facilities, global reach, and a well-earned reputation for trustworthiness. When choosing Taj Pharmaceuticals for Human Albumin Solution BP, one can expect pharmaceutical excellence rooted in a legacy of quality and a sincere dedication to enhancing health and well-being.

What is Human Albumin Solution BP and its uses:

Human Albumin Solution BP (British Pharmacopoeia) is a sterile solution of albumin, a natural protein found in human blood plasma. It is used for various medical purposes due to its unique properties. Here are its primary uses:

  • Blood Volume Replacement: Human Albumin Solution BP is used to restore blood volume in individuals who have experienced significant blood loss due to trauma, surgery, or severe bleeding. It helps maintain adequate circulation and blood pressure.
  • Hypoproteinemia: This solution is used to treat hypoproteinemia, a condition characterized by low levels of protein in the blood. It can occur in conditions such as liver disease, kidney disease, or malnutrition. Albumin supplementation can help increase protein levels in the bloodstream.
  • Burn and Shock Treatment: In cases of severe burns and shock, Human Albumin Solution BP is administered to help stabilize blood volume and maintain vital organ perfusion. It aids in the recovery and healing process.
  • Ascites: Human Albumin Solution BP can be used to manage ascites, a condition where excessive fluid accumulates in the abdominal cavity. It helps alleviate the symptoms and reduces the risk of complications.
  • Nephrotic Syndrome: In some cases of nephrotic syndrome, a kidney disorder characterized by excessive protein loss in the urine, Human Albumin Solution BP may be used to restore protein levels and improve overall health.
  • Plasma Exchange: It is utilized in therapeutic plasma exchange procedures, where abnormal substances are removed from the blood. Human Albumin Solution BP serves as a replacement fluid during these treatments.
  • Supportive Care: In critical care settings, Human Albumin Solution BP may be administered as part of supportive care to manage conditions like severe infections, sepsis, and critical illness.

How Does Human Albumin Solution BP Work?

Human Albumin Solution BP works primarily by its osmotic and oncotic properties, as well as its ability to transport various substances in the bloodstream. Here’s how it works:

  • Osmotic Pressure: Human Albumin Solution BP exerts osmotic pressure in the bloodstream. This means it helps maintain the balance of water between the blood and the surrounding tissues. When administered, it draws water into the blood vessels, increasing blood volume and improving circulation. This property is crucial in conditions where there’s a loss of blood volume due to factors like trauma, surgery, or severe bleeding.
  • Oncotic Pressure: Albumin contributes to oncotic pressure, a component of the osmotic pressure in the bloodstream. It helps to retain water within the blood vessels, preventing excessive fluid from leaking into the surrounding tissues. This is particularly important in conditions where there’s a risk of edema (swelling) due to low levels of albumin, such as in liver or kidney disease.
  • Transport of Substances: Albumin serves as a carrier protein in the blood, transporting various substances such as hormones, fatty acids, bilirubin, and medications. It ensures these substances are effectively delivered to their target tissues and organs. For example, it binds to and transports hormones like thyroid hormones and steroids.
  • Maintenance of Colloid Osmotic Pressure: Albumin helps maintain the colloid osmotic pressure of the blood, which is essential for keeping the fluid within the blood vessels. This pressure opposes hydrostatic pressure (the force that pushes fluid out of blood vessels) and helps prevent the formation of edema in tissues.

Benefits of Human Albumin Solution BP:

  • Blood Volume Restoration: Human Albumin Solution BP is a vital tool for restoring blood volume in individuals who have experienced significant blood loss due to surgery, trauma, or bleeding disorders. It helps stabilize blood pressure and maintain organ perfusion, reducing the risk of shock.
  • Treatment of Hypoproteinemia: This solution is beneficial for individuals with low protein levels in their blood, a condition known as hypoproteinemia. It can be caused by various medical conditions, and Human Albumin Solution BP helps increase protein levels, improving overall health.
  • Burn and Shock Treatment: In cases of severe burns and shock, Human Albumin Solution BP plays a crucial role in stabilizing blood volume and tissue perfusion. It supports the body’s ability to heal and recover.
  • Ascites Management: For individuals with ascites, often associated with liver disease, Human Albumin Solution BP can help reduce fluid buildup in the abdominal cavity, providing relief from discomfort and decreasing the risk of complications.
  • Critical Care Support: In critical care settings, this solution is used as part of supportive care to manage severe infections, sepsis, and critical illness. It aids in maintaining blood volume and organ function during critical periods.

Side Effects of Human Albumin Solution BP:

  • Hypersensitivity Reactions: In some individuals, hypersensitivity reactions may occur, which can manifest as allergic reactions, including rash, itching, or swelling. Severe allergic reactions are rare but require immediate medical attention.
  • Fluid Overload: Excessive administration of Human Albumin Solution BP can potentially lead to fluid overload, causing symptoms like swelling, shortness of breath, and increased blood pressure. Careful dosing and monitoring are essential to prevent this side effect.
  • Transmissible Infections: Although rigorous screening and safety measures are in place, there is a minimal risk of transmitting blood-borne infections when using human plasma-derived products like Human Albumin Solution BP.
  • Coagulation Issues: In rare cases, Human Albumin Solution BP can affect blood coagulation (clotting) and may lead to bleeding problems. This risk is generally low but should be monitored, especially in individuals with a history of bleeding disorders.

Frequently Asked Questions about Human Albumin Solution BP:

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

What is Human Albumin Solution BP used for?

Human Albumin Solution BP is primarily used for restoring blood volume in individuals who have experienced significant blood loss due to surgery, trauma, or bleeding disorders. It is also used to treat conditions like hypoproteinemia, burns, shock, and ascites.

How is Human Albumin Solution BP administered?

Human Albumin Solution BP is typically administered intravenously (IV) by a healthcare professional. The dosage and rate of administration depend on the patient’s condition and needs.

Is Human Albumin Solution BP safe?

Human Albumin Solution BP is considered safe when used as prescribed and under the supervision of healthcare professionals. Rigorous screening and safety measures are in place to minimize the risk of transmitting bloodborne infections.

Are there any potential side effects?

Common side effects may include hypersensitivity reactions, fluid overload, and, in rare cases, coagulation issues. It’s important for healthcare providers to monitor patients for any adverse reactions.

How is the safety of Human Albumin Solution BP ensured?

The safety of Human Albumin Solution BP is ensured through strict screening and testing of blood plasma donors to minimize the risk of transmitting infections. Additionally, manufacturing processes adhere to stringent quality standards.

Can Human Albumin Solution BP be used for other purposes not mentioned in its primary uses?

Human Albumin Solution BP should only be used for its approved indications, as determined by a healthcare provider. Its use for other purposes should be discussed with a medical professional.

Can it be used during pregnancy and breastfeeding?

The use of Human Albumin Solution BP during pregnancy and breastfeeding should be evaluated by a healthcare provider based on the individual’s medical condition and potential benefits versus risks.

Is it compatible with other medications and treatments?

Human Albumin Solution BP may interact with certain medications or treatments. It’s crucial to inform your healthcare provider about all medications and therapies you are receiving to ensure compatibility and safety.

How is the dosage determined?

The dosage of Human Albumin Solution BP is determined by the patient’s medical condition, weight, and specific needs. Healthcare providers carefully calculate and administer the appropriate dosage.

Can I receive Human Albumin Solution BP at home, or must it be administered in a healthcare setting?

The administration of Human Albumin Solution BP typically occurs in a healthcare setting under the supervision of trained medical personnel. Home administration is uncommon and would require specialized arrangements and guidance.

Human Albumin Solution BP 20% (20gm/100ml) Infusion I.V. Export Market

As Human Albumin Infusion 20% Manufacturers, we can cater to business queries from the following geographies. We are exporting our Human Albumin Solution BP 20% Infusion I.V. 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, 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 Albumin Solution 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 Albumin Solution 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