Immune Globulin Intravenous (Human) (Panzyga)

Trade Name : Panzyga

Pfizer Laboratories Div Pfizer Inc

SOLUTION, PLASMA DERIVATIVE

Strength 100 mg/mL

HUMAN IMMUNOGLOBULIN G Human Immunoglobulin G [EPC],Passively Acquired Immunity [PE],Antigen Neutralization [MoA],Immunoglobulins [CS]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Immune Globulin Intravenous (Human) (Panzyga) which is also known as Panzyga and Manufactured by Pfizer Laboratories Div Pfizer Inc. It is available in strength of 100 mg/mL per ml. Read more

Immune Globulin Intravenous (Human) (Panzyga) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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nPANZYGA, Immune Globulin Intravenous (Human) - ifas
n10% Liquid Preparation

nThrombosis may occur with immune globulin intravenous (IGIV) products, including PANZYGA. Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling central vascular catheters, hyperviscosity, and cardiovascular risk factors. Thrombosis may occur in the absence of known risk factors. n
nRenal dysfunction, acute renal failure, osmotic nephrosis, and death may occur in predisposed patients who receive IGIV products, including PANZYGA. Patients predisposed to renal dysfunction include those with a degree of pre-existing renal insufficiency, diabetes mellitus, age greater than 65, volume depletion, sepsis, paraproteinemia, or patients receiving known nephrotoxic drugs. Renal dysfunction and acute renal failure occur more commonly in patients receiving IGIV product containing sucrose. PANZYGA does not contain sucrose.
nFor patients at risk of thrombosis, renal dysfunction or acute renal failure, administer PANZYGA at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity. n, n n
nWARNING: THROMBOSIS, RENAL DYSFUNCTION, and ACUTE RENAL FAILUREn
nSee full prescribing information for complete boxed warning
n- Thrombosis may occur with immune globulin intravenous (IGIV) products, including PANZYGA. Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling vascular catheters, hyperviscosity, and cardiovascular risk factors.
n- Renal dysfunction, acute renal failure, osmotic nephropathy, and death may occur with the administration of IGIV products in predisposed patients. Renal dysfunction and acute renal failure occur more commonly in patients receiving IGIV products containing sucrose. PANZYGA does not contain sucrose.
n-For patients at risk of thrombosis,nrenal dysfunction, or renal failure, administer PANZYGA at the minimum infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity.

nPANZYGA is an immune globulin intravenous (human) - ifas 10% liquid preparation indicated for the treatment of:
nPrimary humoral immunodeficiency (PI) in patients 2 years of age and older (n).
nChronic immune thrombocytopenia (ITP) in adults (n).

nFor intravenous use only.
nFor intravenous use only (n).
nEnsure that patients with pre-existing renal insufficiency are not volume depleted; discontinue PANZYGA if renal function deteriorates (n, n).
nFor patients at risk of renal dysfunction or thrombotic events, administer PANZYGA at the minimum dose and infusion rate practicable (n, n).

nSolution containing 10% IgG (100 mg/mL) n
nSolution containing 10% IgG (100 mg/mL) (n, n)

nHistory of anaphylactic or severe systemic reactions to human immune globulin (n)
nIgAdeficient patients with antibodies against IgA and a history of hypersensitivity (n)

nIgA-deficient patients with antibodies against IgA are at greater risk of developing severe hypersensitivity and anaphylactic reactions to PANZYGA. Epinephrine should be available immediately to treat any severe acute hypersensitivity reactions (n).
nMonitor renal function, including blood urea nitrogen and serum creatinine, and urine output in patients at risk of developing acute renal failure (n).
nHyperproteinemia, increased serum osmolarity and hyponatremia may occur in patients receiving PANZYGA (n).
nHemolysis that is either intravascular or due to enhanced red blood cell sequestration can develop subsequent to PANZYGA treatments. Risk factors for hemolysis include high doses and non-O-blood group. Closely monitor patients for hemolysis and hemolytic anemia (n).
nAseptic Meningitis Syndrome may occur in patients receiving PANZYGA, especially with high doses or rapid infusion (n).
nMonitor patients for pulmonary adverse reactions [transfusion-related acute lung injury (TRALI)] (n).
nPANZYGA is made from human plasma and may contain infectious agents, e.g., viruses, variant Creutzfeldt-Jakob disease [vCJD] agent and, theoretically, the Creutzfeldt-Jakob disease agent (n).

nPI: The most common adverse reactions observed at a rate of more than 5% in subjects in clinical trials were: headache, abdominal pain, fever, nausea, and fatigue.
nChronic ITP in adults: The most common adverse reactions observed at a rate of more than 5% in subjects in clinical trials were: headache, fever, nausea, vomiting, dizziness, and anemia.
nThe most serious adverse reaction observed with PANZYGA treatment during clinical trials was an aseptic meningitis in one subject.
nPI - The most common adverse reactions reported in greater than 5% of subjects during a clinical trial were: headache, nausea, fever, fatigue, and abdominal pain (n).
nChronic ITP in adults - The most common adverse reactions reported in greater than 5% of subjects during a clinical trial were: headache, fever, nausea, vomiting, dizziness, and anemia (n).

nClinical studies have not evaluated mixtures of PANZYGA with other drugs and intravenous solutions. It is recommended that PANZYGA is administered separately from other drugs or medications which the patient may be receiving. Do not mix the product.
nDo not mix PANZYGA with IGIVs from other manufacturers.
nPassively transferred antibodies in immunoglobulin preparations can confound the results of serological testing, e.g. false positive Treponema pallidum testing might occur.
nAntibodies in PANZYGA may interfere with the response to live viral vaccines, such as measles, mumps, and rubella. Inform physicians of recent therapy with PANZYGA, so that administration of live viral vaccines, if indicated, can be appropriately delayed for 3 or more months from the time of PANZYGA administration.
nThe passive transfer of antibodies may confound the results of serological testing (n).n
nThe passive transfer of antibodies may interfere with the immune response to live viral vaccines, such as measles, mumps, and rubella (n).n

nGeriatric Use: In patients over age 65 years and in any patient at risk of developing renal insufficiency, infuse PANZYGA at the minimum infusion rate practicable and do not exceed the recommended dose PANZYGA (n).
n_______________________________________________________________________________________________________________________________________

nWith intravenous administration, overdose may lead to fluid overload and hyperviscosity. Patients at risk of complications of fluid overload and hyperviscosity include elderly patients and those with cardiac or renal impairment.

nImmune Globulin Intravenous (Human), PANZYGA, is a solvent/detergent (S/D)-treated, sterile preparation of highly purified immunoglobulin G (IgG) derived from large pools of human plasma. PANZYGA is a solution for infusion to be administered intravenously.
nThis preparation contains approximately 100 mg of protein per mL (10%), of which not less than 96% is normal human immunoglobulin G. PANZYGA contains not more than 3% aggregates, not less than 90% monomers and dimers, and not more than 3% fragments. On average, the product contains 100 u00b5g/mL of IgA, and lower amounts of IgM.
nPANZYGA contains only trace amounts of sodium, and the pH is between 4.5 and 5.0. The osmolality is in the range of 240-310 mosmol/kg.
nThe manufacturing process for PANZYGA isolates IgG without additional chemical or enzymatic modification, and the Fc portion is maintained intact. PANZYGA contains the IgG antibody activities present in the donor population. IgG subclasses are fully represented with the following approximate percents of total IgG: IgGn is 65%, IgGn is 28%, IgGn is 3% and IgGn is 4%.
nPANZYGA contains a broad spectrum of IgG antibodies against bacterial and viral agents that are capable of opsonization and neutralization of microbes and toxins. PANZYGA contains glycine (15.0-19.5 mg/mL), but no preservatives or sucrose.
nAll units of human plasma used in the manufacture of PANZYGA are provided by FDA-approved blood and plasma establishments, and are tested by FDA-licensed serological tests for HBsAg, antibodies to HCV and HIV and Nucleic Acid Test (NAT) for HCV and HIV1 and found to be non-reactive (negative).
nThe product is manufactured by the cold ethanol fractionation process followed by purification methodologies, as well as S/D treatment and nanofiltration (20 nm). The S/D mixture used is composed of tri-n-butyl phosphate (TNBP, solvent) and Triton X-100 (Octoxynol, detergent). The PANZYGA manufacturing process shows significant viral reduction and inactivation, demonstrated by in vitro infectivity studies (Table 3). The virus safety of PANZYGA is achieved through a combination of various process steps, including S/D treatment, ion-exchange chromatography, and nanofiltration (20 nm).
nTable 3 shows the virus clearance during the manufacturing process for PANZYGA, expressed as the mean logn reduction factor (LRF).
nTable 3: Virus Reduction by PANZYGA Manufacturing Process
nHIV-1: Human Immunodeficiency Virus u2013 1, a model for HIV-1 and HIV-2;
nPRV: Pseudorabies Virus, a model for large enveloped DNA viruses (eg, herpes virus);
nBVDV: Bovine Viral Diarrhea Virus, a model for e.g., Hepatitis C virus (HCV) and West-Nile virus (WNV);
nMEV: Mouse Encephalomyelitis virus, a model for Hepatitis A virus (HAV);
nPPV: Porcine Parvovirus, a model for Human Parvovirus B19;
nn.a.: not applicable;
nn.d: not done.
nAdditionally, the manufacturing process was investigated for its capacity to decrease the infectivity of an experimental agent of transmissible spongiform encephalopathy (TSE), considered as a model for the vCJD and CJD agents. [n]
nSeveral of the individual production steps in the PANZYGA manufacturing process were shown to decrease TSE infectivity of that experimental model agent. TSE reduction steps include ion-exchange chromatography and nanofiltration, which together give a total of at least 10.4 log10 decrease of infectivity. These studies provide reasonable assurance that low levels of CJD/vCJD agent infectivity, if present in the starting material, would be removed.

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nPANZYGA is supplied in 1 g, 2.5 g, 5 g, 10 g, 20 g, and 30 g single-use bottles.
nThe table below shows the details of available presentations of PANZYGA.
nPANZYGA is not supplied with an infusion set. If a filtered infusion set is used (not mandatory), choose a filter size of 0.2-200 microns.
nComponents used in the packaging of PANZYGA are not made with natural rubber latex.
nStore PANZYGA for 24 months at +2u00b0C to +8u00b0C (36u00b0F to 46u00b0F) from the date of manufacture. Within its shelf-life, the product may be stored at u2264u00a0+25u00b0C (77u00b0F) for up to 9 months. After storage at u2264u00a0+25u00b0C (77u00b0F), either use immediately or discard the product.
nDo not use after expiration date.
nDo not freeze. Do not use frozen product.
nPANZYGA contains no preservatives. The PANZYGA bottle is for single use only. Use promptly any bottle that has been entered or opened, and discard partially used bottles.
nDispose of any unused product or waste material in accordance with local requirements.

nInform patients of the signs and symptoms of hypersensitivity reactions including urticaria, generalized urticaria, tightness of the chest, wheezing, hypotension, and anaphylaxis, and to contact their physicians immediately if allergic symptoms occur.
nInform patients to immediately report the signs and symptoms of the following conditions to their physician:
nInform patients that PANZYGA is made from human plasma and may contain infectious agents that can cause disease (e.g., viruses, and theoretically, the CJD agent), and that the risk of infectious agent transmission has been reduced by (a) screening plasma donors for prior exposure to viruses, (b) testing the donated plasma for viral infections and (c) inactivating and/or removing viruses during manufacture.
nInform patients that administration of PANZYGA may interfere with the response to live viral vaccines such as measles, mumps and rubella, and to notify their immunizing physician of their therapy with PANZYGA.
nManufactured by:
nOctapharma Pharmazeutika Produktionsges.m.b.H.
nOberlaaer Strasse 235
n1100 Vienna, Austria
nDistributed by:
nPfizer Labs
nDivision of Pfizer Inc
nNY, NY 10017

nPACKAGE LABEL u2013 PRINCIPAL DISPLAY PANEL
nImmune Globulin Intravenous (Human) - ifas, 10%
nPanzyga
n10 mL
nNDC 0069-1011-02
nCarton
nPanzyga
n25 mL
nNDC 0069-1109-02
nCarton
nPanzyga
n50 mL
nNDC 0069-1224-02
nCarton
nPanzyga
n100 mL
nNDC 0069-1312-02
nCarton
nPanzyga
n200 mL
nNDC 0069-1415-02
nCarton
nPanzyga
n300 mL
nNDC 0069-1558-02
nCarton

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Immune Globulin Intravenous (Human) (Panzyga)

Trade Name : Panzyga

SOLUTION, PLASMA DERIVATIVE

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

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Immune Globulin Intravenous (Human) (Panzyga)

Trade Name : Panzyga

SOLUTION, PLASMA DERIVATIVE

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

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