EPINEPHRINE injection

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

EPINEPHRINE (UNII: YKH834O4BH) (EPINEPHRINE - UNII:YKH834O4BH)

Доступна с:

Lineage Therapeutics Inc

ИНН (Международная Имя):

EPINEPHRINE

состав:

EPINEPHRINE 0.15 mg in 0.15 mL

Тип рецепта:

PRESCRIPTION DRUG

Статус Авторизация:

New Drug Application Authorized Generic

Характеристики продукта

EPINEPHRINE- EPINEPHRINE INJECTION
LINEAGE THERAPEUTICS INC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
EPINEPHRINE INJECTION, USP AUTO-
INJECTOR SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
EPINEPHRINE INJECTION, USP AUTO-
INJECTOR.
EPINEPHRINE INJECTION, USP AUTO-INJECTOR 0.3 MG, 0.15 MG, FOR
INTRAMUSCULAR OR SUBCUTANEOUS USE
INITIAL U.S. APPROVAL: 1939
RECENT MAJOR CHANGES
Dosage and Administration (2) 05/2016
Warnings and Precautions (5.2 , 5.3) 05/2016
INDICATIONS AND USAGE
Epinephrine injection, USP auto-injector contains epinephrine, a
non-selective alpha and beta-adrenergic receptor agonist,
indicated in the emergency treatment of allergic reactions (Type I)
including anaphylaxis. (1)
DOSAGE AND ADMINISTRATION
Patients greater than or equal to 30 kg (66 lbs): Epinephrine
injection, USP auto-injector 0.3 mg (2)
Patients 15 to 30 kg (33 lbs-66 lbs): Epinephrine injection, USP
auto-injector 0.15 mg (2)
Inject epinephrine injection, USP auto-injector intramuscularly or
subcutaneously into the anterolateral aspect of the thigh,
through clothing if necessary. Each device is a single-use injection.
(2)
DOSAGE FORMS AND STRENGTHS
Injection, 0.3 mg: 0.3 mg/0.3 mL epinephrine injection, USP,
pre-filled auto-injector (3)
Injection, 0.15 mg: 0.15 mg/0.15 mL epinephrine injection, USP,
pre-filled auto-injector (3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
In conjunction with use, seek immediate medical or hospital care.
(5.1)
Do not inject intravenously, into buttock, or into digits, hands, or
feet. (5.2)
To minimize the risk of injection related injury, instruct caregivers
to hold the child’s leg firmly in place and limit
movement prior to and during injection when administering to young
children. (5.2)
Rare cases of serious skin and soft tissue infections have been
reported following epinephrine injection. Advise patients
to seek medical care if they develop signs or symptoms of infection.
(5.3)
The presence of a sulf