EVITHROM- human thrombin liquid

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

HUMAN THROMBIN (UNII: 6K15ABL77G) (HUMAN THROMBIN - UNII:6K15ABL77G)

Доступна с:

Ethicon Inc

ИНН (Международная Имя):

Human Thrombin

состав:

Human Thrombin 1000 [iU] in 1 mL

Администрация маршрут:

TOPICAL

Терапевтические показания :

EVITHROM® Thrombin, Topical (Human) is indicated as an aid to hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible and control of bleeding by standard surgical techniques (such as suture, ligature or cautery) is ineffective or impractical. EVITHROM® Thrombin, Topical (Human) may be used in conjunction with an Absorbable Gelatin Sponge, USP. - Do not use in individuals known to have anaphylactic or severe systemic reaction to human blood products. - Do not use for the treatment of severe or brisk arterial bleeding. Risk Summary There are no clinical data with EVITHROM® use in pregnant women to inform a drug-associated risk. Animal reproduction studies have not been conducted with EVITHROM. It is not known whether EVITHROM® can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. In the U.S. general population, the estimated background risk of major birth defect and miscarriage in clinically recognized pregnancies is 2-4

Обзор продуктов:

EVITHROM® is supplied in the following single-use packages, each containing 800-1200 units/ml Thrombin, Topical (Human): Storage and handling

Статус Авторизация:

Biologic Licensing Application

Характеристики продукта

EVITHROM- HUMAN THROMBIN LIQUID
ETHICON INC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
EVITHROM SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR EVITHROM.
EVITHROM [THROMBIN, TOPICAL (HUMAN)
FROZEN SOLUTION FOR TOPICAL USE
INITIAL U.S. APPROVAL: 2007
INDICATIONS AND USAGE
EVITHROM is a topical thrombin indicated as an aid to hemostasis
whenever oozing blood and minor bleeding from
capillaries and small venules is accessible and control of bleeding by
standard surgical techniques (such as suture,
ligature or cautery) is ineffective or impractical _(1)_.
EVITHROM may be used in conjunction with an Absorbable Gelatin Sponge,
USP _(1)_.
DOSAGE AND ADMINISTRATION
FROZEN SOLUTION FOR TOPICAL USE ONLY. DO NOT INJECT _(2.2)_.
The amount of EVITHROM required depends upon the area of tissue to be
treated and the method of application. In
clinical studies, volumes up to 10 ml were used in conjunction with
Absorbable Gelatin Sponge, USP _(2.2)_.
Thaw EVITHROM prior to use in one of the following ways _(2.1)_:
2°C to 8°C (refrigerator): vials thaw within 1 day; or
20°C to 25°C (room temperature): vials thaw within 1 hour; or
37°C FOR 2 ML AND 5 ML VIALS ONLY: vials thaw within 10 minutes and
must not be left at this temperature for longer
than 10 minutes. The temperature must not exceed 37°C.
The time between thawing and application is restricted to 24 hours at
room temperature _(16)_.
Vials are for single use only. Discard unused contents _(2.2)_.
DOSAGE FORMS AND STRENGTHS
EVITHROM is supplied in vials of 2 ml, 5 ml or 20 ml frozen solution
containing 800-1200 units/ml of Thrombin, Topical
(Human) _(3)_.
_The potency expressed in units is determined using a clotting assay
against an internal reference standard for potency that_
_has been calibrated against the World Health Organisation (WHO)
Second International Standard for Thrombin, 01/580._
_Therefore, a unit used herein is equivalent to an International
Unit._
CONTRAINDICATIONS
DO