VARIZIG- human varicella-zoster immune globulin solution

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

HUMAN VARICELLA-ZOSTER IMMUNE GLOBULIN (UNII: 33T61IWL27) (HUMAN VARICELLA-ZOSTER IMMUNE GLOBULIN - UNII:33T61IWL27)

Tilgjengelig fra:

Saol Therapeutics

Administreringsrute:

INTRAMUSCULAR

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

VARIZIG® [Varicella Zoster Immune Globulin (Human)] is indicated for post-exposure prophylaxis of varicella in high risk individuals. High risk groups include: - immunocompromised children and adults, - newborns of mothers with varicella shortly before or after delivery, - premature infants, - neonates and infants less than one year of age, - adults without evidence of immunity, - pregnant women. VARIZIG administration is intended to reduce the severity of varicella. Administer VARIZIG as soon as possible following varicella zoster virus (VZV) exposure, ideally within 96 hours for greatest effectiveness. - There is no convincing evidence that VARIZIG reduces the incidence of chickenpox infection after exposure to VZV. - There is no convincing evidence that established infections with VZV can be modified by VARIZIG administration. - There is no indication for the prophylactic use of VARIZIG in immunodeficient children or adults when there is a past history of varicella, unless the patient is undergoing bone m

Produkt oppsummering:

NDC 70257-126-51: VARIZIG [Varicella Zoster Immune Globulin (Human)] is supplied as a sterile liquid approximately 125 international units of anti-VZV in a glass tubing vial and a package insert. Store VARIZIG at 2 to 8°C (36 to 46°F). Do not freeze. Do not use after expiration date.

Autorisasjon status:

Biologic Licensing Application

Preparatomtale

VARIZIG- HUMAN VARICELLA-ZOSTER IMMUNE GLOBULIN SOLUTION
SAOL THERAPEUTICS
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
VARIZIG SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR VARIZIG.
VARIZIG [VARICELLA ZOSTER IMMUNE GLOBULIN (HUMAN)]
FOR INTRAMUSCULAR ADMINISTRATION ONLY.
STERILE SOLUTION FOR INJECTION
INITIAL U.S. APPROVAL: 2012
INDICATIONS AND USAGE
VARIZIG is a Varicella Zoster Immune Globulin (Human) indicated for
post-exposure prophylaxis in high
risk individuals (1). High risk groups include:
immunocompromised children and adults,
newborns of mothers with varicella shortly before or after delivery,
premature infants,
infants less than one year of age,
adults without evidence of immunity,
pregnant women.
VARIZIG administration is intended to reduce the severity of
varicella.
DOSAGE AND ADMINISTRATION
INTRAMUSCULAR USE ONLY.
Dosing of VARIZIG is based on body weight. Administer a single dose of
VARIZIG intramuscularly as
recommended in the following table (2.1):
≤: less than or equal to
>: greater than
WEIGHT OF PATIENT (KG)
DOSE (INTERNATIONAL UNITS)
NUMBER OF VIALS
≤2.0
62.5
0.5
2.1–10.0
125
1
10.1–20.0
250
2
20.1–30.0
375
3
30.1–40.0
500
4
>40.1
625
5
Discard any partial vials.
The intramuscular dose should be divided and administered in two
sites, dependent on patient size. Do
not exceed 3 mL per injection site (2.2).
DOSAGE FORMS AND STRENGTHS
VARIZIG is supplied as a sterile solution for intramuscular injection
and is available in a single-use vial of
125 international units in 1.2 mL (3).
CONTRAINDICATIONS
History of anaphylactic or severe systemic reactions to human immune
globulins (4).
IgA-deficient patients with antibodies against IgA and a history of
hypersensitivity (4).
WARNINGS AND PRECAUTIONS
Thrombotic events (5.1)
Coagulation disorders (5.2)
®
®
Hypersensitivity (5.3)
Transmissible infectious agents (5.4)
ADVERSE REACTIONS
Most common adverse reactions from clinical trials are pain at the
injec