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 outer carton in order to protect 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 treatment of 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.

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.