CNJ-016 (vaccinia immune globulin- human injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

HUMAN VACCINIA VIRUS IMMUNE GLOBULIN (UNII: 7UB4J759TD) (HUMAN VACCINIA VIRUS IMMUNE GLOBULIN - UNII:7UB4J759TD)

Available from:

Emergent BioSolutions Canada Inc.

INN (International Name):

HUMAN VACCINIA VIRUS IMMUNE GLOBULIN

Composition:

HUMAN VACCINIA VIRUS IMMUNE GLOBULIN 1 [iU] in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

VIGIV (vaccinia immune globulin intravenous, human) is indicated for the treatment and/or modification of the following conditions: VIGIV is not considered to be effective in the treatment of postvaccinial encephalitis. VIGIV is contraindicated in: Risk Summary There are no data on the use of VIGIV in pregnant women to inform on drug-associated risk. Animal reproduction studies have not been conducted with VIGIV. Risk Summary There are no data to assess the presence or absence of VIGIV in human milk, the effects on the breastfed child or the effects on milk production/excretion. Safety and effectiveness in the pediatric population (<16 yrs of age) has not been established for VIGIV. Safety and effectiveness in the geriatric population (>65 yrs of age) has not been established for VIGIV.

Product summary:

NDC 60492-0173-1 The product is supplied as a 20 mL single dose vial containing ≥50,000 Units per vial. It is packaged in a shelf carton with 24 vials and four package inserts. VIGIV does not contain natural rubber latex. Product may be stored frozen at or below 5°F (≤-15°C) or refrigerated at 36 to 46°F (2 to 8°C); refer to label for appropriate storage conditions. Do not use after expiration date. If product is received frozen, use within 60 days of thawing at 2 to 8°C. Begin intravenous infusion within 4 hours after entering the vial. Do not reuse or save VIGIV for future use. This product contains no preservative; therefore, discard partially used vials.

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

CNJ-016- VACCINIA IMMUNE GLOBULIN (HUMAN) INJECTION
EMERGENT BIOSOLUTIONS CANADA INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CNJ-016 (VACCINIA IMMUNE GLOBULIN
INTRAVENOUS, HUMAN), VIGIV SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR VIGIV.
VIGIV (VACCINIA IMMUNE GLOBULIN, HUMAN), 5% STERILE SOLUTION FOR
INTRAVENOUS USE.
INITIAL U.S. APPROVAL: 2005
WARNING: INTERACTIONS WITH GLUCOSE MONITORING SYSTEMS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_
Blood glucose measurement in patients receiving VIGIV (vaccinia immune
globulin intravenous, human) must be
done with a glucose-specific method (monitor and test strips) to avoid
interference by maltose contained in VIGIV.
Maltose in IGIV products may give falsely high blood glucose levels in
certain types of blood glucose testing systems
(for example those based on the GDH-PQQ or glucose-dye-oxidoreductase
methods) resulting in inappropriate
administration of insulin and life-threatening hypoglycemia. Cases of
true hypoglycemia may go untreated if the
hypoglycemic state is masked by falsely elevated glucose readings.
RECENT MAJOR CHANGES
WARNINGS AND PRECAUTIONS, Aseptic Meningitis Syndrome (5.6) 11/2018
INDICATIONS AND USAGE
VIGIV is an Immune Globulin (Human), 5% Liquid, indicated for the
treatment of complications due to vaccinia vaccination
(1), including:
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VIGIV is not indicated for postvaccinial encephalitis (1)
DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
Sterile solution available as 20 mL single-use vial containing a dose
of ≥50,000 Units per vial (3).
CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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DOSAGE AND ADMINISTRATION, Preparation (2.2) 11/2018
DOSAGE AND ADMINISTRATION, Administration (2.3) 11/2018
WARNINGS AND PRECAUTIONS, Thrombosis (5.4) 11/2018
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Aberrant infection