GENERIC NAME OF THE MEDICINAL PRODUCT:

a) Human Normal Immunoglobulin BP 5% (5gm/100ml)
b) Human Normal Immunoglobulin BP 5%(2.5gm/50ml)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

a) Human Normal Immunoglobulin BP 5% (5gm/100ml)
Each vial contains:
Human Immunoglobulin ……………………50g/l
IgG……………………………………………………..>95%
Maltose……………………………………………..100g/l
Water for Injection…………………………….q.s.
IgA content is not more than 2mg/ml the distribution of IgG subclass is similar to that found in normal human serum

b) Human Normal Immunoglobulin BP 5%(2.5gm/50ml)
Each ml contains:
Human Immunoglobulin ……………………100mg
IgG……………………………………………………..>96%
Water for Injection…………………………….q.s.
IgA content is not more than 2mg/ml the distribution of IgG subclass is similar to that found in normal human serum

THERAPEUTIC INDICATIONS:

Intravenous immunoglobulin (IVIG) is a pooled antibody, and a biological agent used to manage various immunodeficiency states and a plethora of other conditions, including autoimmune, infectious, and inflammatory states. The ultimate goal of this therapy is to normalize a compromised immune system
.

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 tests mentioned in national institute of Biologics.

DOSAGE AND ADMINISTRATION:

Do not use if the solution is turbid or any particulate matter observed See package insert.

CAUTION & WARNING:

Caution: See package insert for further details. Do not use the medicine after expiry date.
The transmission of infection agents can not be excluded when medical products prepared from human blood or plasma are administered.
Warning: Do not freeze.
To be sold by retail on the prescription of the Registered Medical pharmacist only.
Non reactive For HBsAG, HCV, HIV I & II antibodies and negative for HIV I & II, HCV, HBV by NAT.
irrespective of blood group, can be administered to all recipient.

STORAGE & DOSAGE:

Storage: Store at 2 to 8˚C (36˚F to 46˚F). Store the vial in outer carton in order to protect from light.
Keep the medicine out of reach and sight of children.
Shelf life of 24 months when stored at room temperature(up to 2˚C)
Dosage: As directed by the physician.

Human Normal Immunoglobulin BP 5% (5g/100ml) Technical Specification:

Product Name:Human Normal Immunoglobulin BP 5%
Brand Name:Aizen Life
Strength:5g/100ml, 2.5g/50ml
Dosage Form:Liquid Injection
Packing:Infusion Glass Bottle Vials (Sterile), non-pyrogenic, Single-use Container
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 HIV-1 & HIV-2, HCV, HBV by NAT.
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 I & II antibodies and Negative for HIV I & II, HCV, HBV by NAT.
Therapeutic use:Antibodies
Indication: Human Normal Immunoglobulin (Intravenous Immunoglobulin – IVIG) is a pooled antibody, and a biological agent used to manage various immunodeficiency states and a plethora of other conditions, including autoimmune, infectious, and inflammatory states. The ultimate goal of this therapy is to normalize a compromised immune system
Storage:Store at 2˚C to 8˚C (36˚F to 46˚F). Store the vial in an outer carton in order to protect it from light.

Human Normal Immunoglobulin BP 5% Infusion I.V. Manufacturers & Exporters in PAN India and Overseas

Taj Pharmaceuticals is acclaimed as one of the leading manufacturers of Human Normal Immunoglobulin BP 5% (5gm/100ml) in India and exporter in PAN India and overseas. It is available in two different strengths with us that are 5% (5gm/100ml) and 5%(2.5gm/50ml). The autoimmune Injection is manufactured according to the set guidelines of the regulatory bodies and thus is safe to in use. This Blood Derivative is used to treat various autoimmune diseases and conditions that cause the body to recognize a part of itself as foreign and generate proteins (called autoantibodies) that attack part of the body. These proteins are found in the plasma component of blood.

GENERIC NAME OF THE MEDICINAL PRODUCT:

 QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Human Normal Immunoglobulin BP 5% (5gm/100ml)
    Each vial contains:
    Human Immunoglobulin ……………………50g/l
    IgG……………………………………………………..>95%
    Maltose……………………………………………..100g/l
    Water for Injection…………………………….q.s.
    IgA content is not more than 2mg/ml the distribution of IgG subclass is similar to that found in normal human serum
  • Human Normal Immunoglobulin BP 5%(2.5gm/50ml)
    Each ml contains:
    Human Immunoglobulin ……………………100mg
    IgG……………………………………………………..>96%
    Water for Injection…………………………….q.s.
    IgA content is not more than 2mg/ml the distribution of IgG subclass is similar to that found in normal human serum

THERAPEUTIC INDICATIONS:

Human Normal Immunoglobulin BP 5% (Intravenous immunoglobulin – IVIG) is a pooled antibody, and a biological agent used to manage various immunodeficiency states and a plethora of other conditions, including autoimmune, infectious, and inflammatory states. The ultimate goal of this therapy is to normalize a compromised immune system.

Intravenous Immunoglobulin (IVIG) is a therapy treatment for patients with antibody deficiencies. It is prepared from a pool of immunoglobulins (antibodies) from the plasma of thousands of healthy donors. Immunoglobulins are made by the immune system of healthy people for the purpose of fighting infections.

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 tests mentioned in the National Institute of Biologics

DOSAGE AND ADMINISTRATION:

Do not use if the solution is turbid or any particulate matter is observed See package insert.

CAUTION & WARNING:

Caution: See package insert for further details. Do not use the medicine after expiry date. 
The transmission of infection agents can not be excluded when medical products prepared from human blood or plasma are administered. 

Warning: Do not freeze.
To be sold by retail on the prescription of the Registered Medical pharmacist only.
Non-reactive For HBsAg, HCV, HIV I & II antibodies and Negative for HIV I & II, HCV, HBV by NAT.
irrespective of blood group, can be administered to all recipients.

STORAGE & DOSAGE:

Storage: Store at 2 to 8˚C (36˚F to 46˚F). Store the vial in outer carton in order to protect from light.
Keep the medicine out of reach and sight of children.
Shelf life of 24 months when stored at room temperature(up to 2˚C)

Dosage: As directed by the physician.

Why Taj Pharmaceuticals? 

Taj Pharmaceuticals is the preferred choice for Human Normal Immunoglobulin BP (British Pharmacopoeia) due to several compelling reasons:

  • Pharmaceutical Expertise: Taj Pharmaceuticals boasts decades of experience in the pharmaceutical industry. This expertise translates into a deep understanding of immunoglobulin products and their critical role in healthcare.
  • Commitment to Quality: Taj Pharmaceuticals is renowned for its unwavering commitment to quality and safety in pharmaceutical products. Human Normal Immunoglobulin BP is manufactured to the highest standards, ensuring its effectiveness and reliability.
  • Global Reach: Taj Pharmaceuticals is not only a respected manufacturer in India but also an exporter from India. This global presence means that their high-quality immunoglobulin products are accessible to a worldwide audience, contributing to global healthcare.
  • Advanced Manufacturing Facilities: Taj Pharmaceuticals operates state-of-the-art pharmaceutical manufacturing facilities, including the Taj Pharma plant in Vapi, Gujarat. These facilities adhere to stringent quality control measures, ensuring precise and consistent production.
  • Proven Track Record: Taj Pharmaceuticals has earned trust and reliability among healthcare providers, institutions, and patients. Their reputation as a dependable supplier of essential pharmaceuticals, including Human Normal Immunoglobulin BP, underscores their commitment to quality and safety.
  • Patient-Centric Approach: Taj Pharmaceuticals places the well-being of patients at the forefront. Their dedication to providing reliable immunoglobulin products is a testament to their commitment to improving the lives of individuals who depend on these medications. Choose Taj Pharmaceuticals for your Human Normal Immunoglobulin BP needs and experience pharmaceutical excellence rooted in a legacy of quality and a genuine commitment to enhancing health and well-being.

What is Human Normal Immunoglobulin BP and its uses:

Human Normal Immunoglobulin BP (British Pharmacopoeia), often referred to as immunoglobulin or Ig, is a blood product derived from human plasma that contains a concentrated mixture of antibodies. These antibodies play a crucial role in the immune system’s defense against infections and diseases. Here are its primary uses:

  • Immune Disorders: Human Normal Immunoglobulin BP is commonly used to treat various immune system disorders, including primary immunodeficiency disorders (PIDs). PIDs are a group of genetic disorders that impair the body’s ability to mount an effective immune response. Administering immunoglobulin helps provide the missing antibodies, enhancing the immune system’s function.
  • Autoimmune Diseases: It is also used to manage certain autoimmune diseases where the immune system mistakenly attacks the body’s tissues. Conditions like immune thrombocytopenia (ITP), Guillain-Barré syndrome (GBS), and chronic inflammatory demyelinating polyneuropathy (CIDP) may be treated with immunoglobulin to modulate the immune response.
  • Infections: Immunoglobulin may be used as a prophylactic treatment in individuals with compromised immune systems to prevent infections, particularly in cases of recurrent or severe infections.
  • Kawasaki Disease: It is used in the treatment of Kawasaki disease, a rare childhood illness that affects blood vessels and can lead to serious complications if not treated promptly.
  • Hematological Disorders: Immunoglobulin may be prescribed for certain hematological disorders, such as immune-mediated hemolytic anemia, where the immune system attacks red blood cells.
  • Chronic Inflammatory Conditions: In some cases, it is used to manage chronic inflammatory conditions, such as systemic lupus erythematosus (SLE), to help modulate the immune response and reduce symptoms.
  • Organ Transplants: Immunoglobulin may be used in the context of organ transplantation to reduce the risk of graft rejection.
  • Neurological Disorders: It can be employed in the treatment of specific neurological disorders, including multifocal motor neuropathy and stiff-person syndrome.

Human Normal Immunoglobulin BP is administered via intravenous (IV) infusion and provides a concentrated source of antibodies that can help regulate and support the immune system in various medical conditions. Its use is typically guided by a healthcare provider based on the specific diagnosis and needs of the patient.

How does Human Normal Immunoglobulin BP work?

Human Normal Immunoglobulin BP, commonly known as immunoglobulin or Ig, works by providing a concentrated mixture of antibodies that serve various essential functions in the immune system. Here’s how it works:

  • Antibody Supply: Immunoglobulin contains a diverse range of antibodies, including immunoglobulin G (IgG), immunoglobulin A (IgA), immunoglobulin M (IgM), immunoglobulin D (IgD), and immunoglobulin E (IgE). These antibodies are produced by B lymphocytes in the body and play a vital role in the immune response.
  • Immune Defense: Antibodies are the body’s natural defense against pathogens such as bacteria, viruses, and other foreign invaders. When these pathogens enter the body, antibodies bind to them, neutralizing their harmful effects.
  • Pathogen Recognition: Each type of antibody has a specific structure that allows it to recognize and bind to a particular antigen or pathogen. This antigen-antibody binding is highly specific, enabling the immune system to target and combat a wide range of pathogens effectively.
  • Immune Modulation: In certain immune system disorders, such as primary immunodeficiency disorders (PIDs) and autoimmune diseases, the immune system’s balance is disrupted. Immunoglobulin therapy can help modulate the immune response. In cases of PID, where the patient’s immune system lacks specific antibodies, immunoglobulin therapy provides the missing antibodies, enhancing the immune system’s ability to fight infections.
  • Anti-Inflammatory Effects: Immunoglobulin therapy may also have anti-inflammatory effects. It can help reduce the production of inflammatory cytokines and molecules that contribute to autoimmune diseases and other inflammatory conditions.
  • Immune System Regulation: Immunoglobulin therapy can help regulate an overactive immune system, preventing it from attacking the body’s own tissues, as seen in autoimmune diseases like Guillain-Barré syndrome (GBS) and chronic inflammatory demyelinating polyneuropathy (CIDP).
  • Immune Support: In individuals with compromised immune systems, such as those undergoing chemotherapy or organ transplantation, immunoglobulin therapy provides additional support to help prevent severe infections.

Benefits of Human Normal Immunoglobulin BP:

  • Immune System Support: One of the primary benefits of Human Normal Immunoglobulin BP is its role in supporting the immune system. It provides a concentrated source of antibodies that can enhance the immune response, particularly in individuals with primary immunodeficiency disorders (PIDs) who lack these antibodies.
  • Infection Prevention: Immunoglobulin therapy can help prevent infections in individuals with compromised immune systems, reducing the risk of severe or recurrent infections. This is particularly valuable for patients undergoing chemotherapy or bone marrow transplantation.
  • Treatment of Autoimmune Diseases: It is used to manage various autoimmune diseases, including Guillain-Barré syndrome (GBS), chronic inflammatory demyelinating polyneuropathy (CIDP), and immune thrombocytopenia (ITP). By modulating the immune response, it can help reduce symptoms and improve the quality of life for individuals with these conditions.
  • Kawasaki Disease Treatment: Human Normal Immunoglobulin BP is an effective treatment for Kawasaki disease, a rare childhood illness that affects blood vessels. Prompt treatment with immunoglobulin can reduce the risk of serious complications associated with the disease.
  • Hematological Disorders: In cases of immune-mediated hemolytic anemia and certain other hematological disorders, immunoglobulin therapy can help manage the condition by modulating the immune system’s response.

Side Effects of Human Normal Immunoglobulin BP:

  • Hypersensitivity Reactions: Like any medication, immunoglobulin therapy can occasionally lead to hypersensitivity reactions. These reactions can range from mild symptoms like rash and itching to severe anaphylactic reactions. Therefore, it is administered under medical supervision to monitor and manage any potential reactions.
  • Flu-Like Symptoms: Some individuals may experience mild flu-like symptoms, such as fever, chills, headache, or muscle pain, shortly after receiving immunoglobulin therapy. These symptoms are generally temporary and subside on their own.
  • Renal Dysfunction: In rare cases, high-dose immunoglobulin therapy may lead to renal dysfunction, especially in individuals with preexisting kidney conditions. Regular monitoring is essential to detect any kidney-related issues.
  • Thrombotic Events: There is a small risk of thrombotic events (blood clots) associated with immunoglobulin therapy, particularly in individuals with a history of thrombotic disorders or cardiovascular risk factors.
  • Fluid Overload: Excessive administration of immunoglobulin can lead to fluid overload, resulting in symptoms like swelling, shortness of breath, and increased blood pressure.
  • Headache and Fatigue: Some patients may experience mild headache, fatigue, or dizziness during or after immunoglobulin infusion. These symptoms are usually transient.

Frequently Asked Questions about Human Normal Immunoglobulin BP 5% (5gm/100ml):

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

What is Human Normal Immunoglobulin BP (Immunoglobulin)?

Human Normal Immunoglobulin BP is a blood product that contains a concentrated mixture of antibodies. It is derived from human plasma and is used to treat various immune system disorders and provide immune support.

What are the primary uses of Human Normal Immunoglobulin BP?

Human Normal Immunoglobulin BP is primarily used to treat primary immunodeficiency disorders (PIDs), autoimmune diseases, prevent infections in immunocompromised individuals, and manage conditions like GuillainBarré syndrome (GBS), immune thrombocytopenia (ITP), and Kawasaki disease.

How is Human Normal Immunoglobulin BP administered?

It is typically administered as an intravenous (IV) infusion by a healthcare professional. The dosage and frequency of administration depend on the specific medical condition being treated.

Is Human Normal Immunoglobulin BP safe?

When used as prescribed and under medical supervision, Human Normal Immunoglobulin BP is considered safe. However, there can be potential side effects, and patients are closely monitored during administration.

What are the common side effects of immunoglobulin therapy?

Common side effects may include mild flulike symptoms, such as fever, chills, headache, or muscle pain. Some individuals may also experience hypersensitivity reactions, although severe reactions are rare.

Can it be used in children and adults alike?

Yes, Human Normal Immunoglobulin BP can be used in both children and adults, depending on the specific medical condition and treatment plan.

How often is immunoglobulin therapy administered?

The frequency of administration varies depending on the underlying condition. Some patients may receive immunoglobulin infusions monthly, while others may have a different schedule based on their needs.

Can immunoglobulin therapy replace missing antibodies in individuals with immunodeficiency disorders?

Yes, one of the primary purposes of immunoglobulin therapy is to provide missing antibodies in individuals with primary immunodeficiency disorders. It helps enhance the immune response in these individuals.

Are there any special precautions or considerations before starting immunoglobulin therapy?

Patients should inform their healthcare providers about any allergies, underlying medical conditions, or medications they are taking. Additionally, immunoglobulin therapy may require adjustments if patients have kidney or heart conditions.

How long does it take to see improvements in the treated condition?

The time it takes to see improvements varies depending on the condition being treated. Some individuals may experience relief relatively quickly, while others may require more time to respond to treatment.

Human Normal Immunoglobulin BP 5% (5gm/100ml) Infusion I.V. Export Market

As Human Normal Immunoglobulin BP 5% (5gm/100ml) Infusion, We can cater business queries from the following geographies. We are exporting our Human Normal Immunoglobulin BP 5% Infusion I.V. in the following Countries: –

Russia and CIS Countries: Azerbaijan, Armenia, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Russia, Tajikistan, Turkmenistan, Uzbekist an 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.