HYPERRAB (rabies immune globulin- human injection, solution

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

Human Rabies Virus Immune Globulin (UNII: 95F619ATQ2) (Human Rabies Virus Immune Globulin - UNII:95F619ATQ2)

Доступна с:

GRIFOLS USA, LLC

ИНН (Международная Имя):

Human Rabies Virus Immune Globulin

состав:

Human Rabies Virus Immune Globulin 300 [iU] in 1 mL

Администрация маршрут:

INTRAMUSCULAR

Терапевтические показания :

HYPERRAB is a human rabies immune globulin indicated for postexposure prophylaxis, along with rabies vaccine, for all persons suspected of exposure to rabies. Limitations of Use Persons who have been previously immunized with rabies vaccine and have a confirmed adequate rabies antibody titer should receive only vaccine.(1-3) For unvaccinated persons, the combination of HYPERRAB and vaccine is recommended for both bite and nonbite exposures regardless of the time interval between exposure and initiation of postexposure prophylaxis.(1-3) Beyond 7 days (after the first vaccine dose), HYPERRAB is not indicated since an antibody response to vaccine is presumed to have occurred. None. Risk Summary There are no data with HYPERRAB use in pregnant women to inform a drug-associated risk.  Animal reproduction studies have not been conducted with HYPERRAB.  It is not known whether HYPERRAB can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.  HYPERRAB should be given to a pregna

Обзор продуктов:

HYPERRAB is supplied in 1 mL, 3 mL and 5 mL single-dose vials of ready-to-use solution with a potency value of not less than 300 IU/mL. HYPERRAB contains no preservative and is not made with natural rubber latex.

Статус Авторизация:

Biologic Licensing Application

Характеристики продукта

HYPERRAB- RABIES IMMUNE GLOBULIN (HUMAN) INJECTION, SOLUTION
GRIFOLS USA, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
HYPERRAB SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR HYPERRAB.
HYPERRAB [RABIES IMMUNE GLOBULIN (HUMAN)] SOLUTION FOR INFILTRATION
AND INTRAMUSCULAR
INJECTION
INITIAL U.S. APPROVAL: 1974
INDICATIONS AND USAGE
HYPERRAB is a human rabies immune globulin indicated for postexposure
prophylaxis, along with rabies
vaccine, for all persons suspected of exposure to rabies. (1)
Limitations of Use
Persons previously immunized with rabies vaccine that have a confirmed
adequate rabies antibody titer
should receive only vaccine.
For unvaccinated persons, the combination of HYPERRAB and vaccine is
recommended for both bite and
nonbite exposures regardless of the time interval between exposure and
initiation of postexposure
prophylaxis.
Beyond 7 days (after the first vaccine dose), HYPERRAB is not
indicated since an antibody response to
vaccine is presumed to have occurred.
DOSAGE AND ADMINISTRATION
FOR INFILTRATION AND INTRAMUSCULAR USE ONLY.
ADMINISTER HYPERRAB WITHIN 7 DAYS AFTER THE FIRST DOSE OF RABIES
VACCINE.
Postexposure prophylaxis, along with
rabies vaccine, after suspected
exposure to rabies (2.1)
HYPERRAB
20 IU/kg
body
weight
OR
0.0665
mL/kg
body
weight
Single-
dose
Administer as soon as possible after exposure,
preferably at the time of the first rabies vaccine
dose.
Infiltrate the full dose of HYPERRAB thoroughly
in the area around and into the wound(s), if
anatomically feasible.
Inject the remainder, if any, intramuscularly.
DOSAGE FORMS AND STRENGTHS
300 IU/mL solution for injection supplied in 1 mL, 3mL and 5 mL
single-dose vials. (3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
Severe hypersensitivity reactions, including anaphylaxis, may occur
with HYPERRAB. Have epinephrine
available immediately to treat any acute severe hypersensitivity
reactions. (5.1)
HYPERRAB is made from human blood, it ma