PANZYGA (immune globulin intravenous- human solution

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

HUMAN IMMUNOGLOBULIN G (UNII: 66Y330CJHS) (HUMAN IMMUNOGLOBULIN G - UNII:66Y330CJHS)

Disponible depuis:

Pfizer Laboratories Div Pfizer Inc

Mode d'administration:

Intravenous

indications thérapeutiques:

PANZYGA is indicated for treatment of primary humoral immunodeficiency (PI) in patients 2 years of age and older. This includes, but is not limited to, congenital agammaglobulinemia, common variable immunodeficiency, X-linked agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies. PANZYGA is indicated for the treatment of adult patients with ITP to raise platelet counts to control or prevent bleeding. PANZYGA is indicated for the treatment of adults with chronic inflammatory demyelinating polyneuropathy (CIDP) to improve neuromuscular disability and impairment. - PANZYGA is contraindicated in patients who have a history of severe systemic hypersensitivity reactions, such as anaphylaxis, to human immunoglobulin. - PANZYGA is contraindicated in IgA-deficient patients with antibodies against IgA and history of hypersensitivity . Risk Summary No human data are available to indicate the presence or absence of drug-associated risk. Animal reproduction studies have not been conducted

Descriptif du produit:

PANZYGA is supplied in 1 g, 2.5 g, 5 g, 10 g, 20 g, and 30 g single-use bottles. The table below shows the details of available presentations of PANZYGA. PANZYGA 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. Components used in the packaging of PANZYGA are not made with natural rubber latex. Store PANZYGA for 36 months at +2°C to +8°C (36°F to 46°F) from the date of manufacture. Within its shelf-life, the product may be stored at ≤ +25°C (77°F) for up to 12 months. After storage at ≤ +25°C (77°F), either use immediately or discard the product. Do not use after expiration date. Do not freeze. Do not use frozen product. PANZYGA 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. Dispose of any unused product or waste material in accordance with local requirements.

Statut de autorisation:

Biologic Licensing Application

Résumé des caractéristiques du produit

PANZYGA- IMMUNE GLOBULIN INTRAVENOUS (HUMAN) SOLUTION
PFIZER LABORATORIES DIV PFIZER INC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PANZYGA SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR PANZYGA.
PANZYGA, (IMMUNE GLOBULIN INTRAVENOUS, HUMAN - IFAS)
10% LIQUID PREPARATION
INITIAL U.S. APPROVAL: 2018
WARNING: THROMBOSIS, RENAL DYSFUNCTION, AND ACUTE RENAL FAILURE
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_
- 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.
- 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.
-FOR PATIENTS AT RISK OF THROMBOSIS, RENAL 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.
RECENT MAJOR CHANGES
Indications and Usage (1) 01/2021
Dosage and Administration, Dose (2.1) 01/2021
INDICATIONS AND USAGE
PANZYGA is an immune globulin intravenous (human) - ifas 10% liquid
preparation indicated for the
treatment of:
• Primary humoral immunodeficiency (PI) in patients 2 years of age
and older ( 1.1 ).
• Chronic immune thrombocytopenia (ITP) in adults ( 1.2 ).
• Chronic inflammatory demyelinating polyneuropathy (CIDP) in adults
(1.3)
DOSAGE AND ADMINISTRATION
FOR INTRAVENOUS USE ONLY ( 2 ).
INDICATION
DOSE
INITIAL
INFUSION RATE
MAXIMUM INFUSION
RATE (AS TOLERATED)
PI
300-