VARIZIG (varicella zoster immune globulin- human liquid

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Viambatanisho vya kazi:

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

Inapatikana kutoka:

Cangene BioPharma

INN (Jina la Kimataifa):

HUMAN VARICELLA-ZOSTER IMMUNE GLOBULIN

Tungo:

HUMAN VARICELLA-ZOSTER IMMUNE GLOBULIN 1.25 [iU] in 1 mL

Njia ya uendeshaji:

INTRAMUSCULAR

Matibabu dalili:

VARIZIG® [Varicella Zoster Immune Globulin (Human)] is indicated for post-exposure prophylaxis of varicella in high risk individuals. High risk groups include: 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. Pregnancy category C. Animal reproduction studies have not been conducted with VARIZIG. It also is not known whether VARIZIG can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. VARIZIG should be given to a pregnant woman only if clearly needed. The safety and effectiveness of VARIZIG have been evaluated for post-exposure prophylaxis in clinical trials in 166 pregnant women [see 6 ADVERSE REACTIONS and 14 CLINICAL STUDIES]. It is not known whether VARIZIG is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when VARIZIG is administered to a nursing moth

Bidhaa muhtasari:

NDC 53270-0126-2: VARIZIG [Varicella Zoster Immune Globulin (Human)] is supplied as a sterile liquid approximately 125 IU of anti-VZV in a 3 mL type 1 glass tubing vial fitted with a 13 mm rubber stopper and a 13 mm flip-off seal, and a package insert. Store VARIZIG at 2 to 8°C (36 to 46°F). Do not freeze. Do not use after expiration date.

Idhini hali ya:

Biologic Licensing Application

Tabia za bidhaa

VARIZIG- VARICELLA ZOSTER IMMUNE GLOBULIN (HUMAN) LIQUID
CANGENE BIOPHARMA
----------
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
RECENT MAJOR CHANGES
Dosage and Administration, Preparation and Handling (2.1)
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:
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):
WEIGHT OF PATIENT (KG)
DOSE (IU)
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 IU in 1.2 mL
(3).
CONTRAINDICATIONS
WARNINGS AND PRECAUTIONS
®
®
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.
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).
Thrombotic events (5.1)
Coagulation disorders (5.2)
ADVERSE REACTIONS
Most common adverse reactions from clinical trials are pain at the
injection site (3%) and headache (2%) (6).
To report SUSPECTED AD