EPINEPHRINE injection

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

Teva Pharmaceuticals USA, Inc.

מסלול נתינה (של תרופות):

INTRAMUSCULAR

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

Epinephrine Injection, 0.3 mg and Epinephrine Injection, 0.15 mg are indicated in the emergency treatment of allergic reactions (Type I) including anaphylaxis to stinging insects (e.g., order Hymenoptera, which include bees, wasps, hornets, yellow jackets and fire ants) and biting insects (e.g., triatoma, mosquitoes), allergen immunotherapy, foods, drugs, diagnostic testing substances (e.g., radiocontrast media) and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis. Epinephrine Injection, 0.3 mg and Epinephrine Injection, 0.15 mg are intended for immediate administration in patients who are determined to be at increased risk for anaphylaxis, including individuals with a history of anaphylactic reactions. Anaphylactic reactions may occur within minutes after exposure and consist of flushing, apprehension, syncope, tachycardia, thready or unobtainable pulse associated with a fall in blood pressure, convulsions, vomiting, diarrhea and abdominal cramps, involuntary voiding, wheezi

leaflet_short:

How Supplied Epinephrine Injection USP, 0.3 mg (Auto-Injectors) is supplied with two single-dose pre-filled auto-injectors and one auto-injector trainer device: 0.3 mg/0.3 mL (NDC 0093-5986-27). Epinephrine Injection USP, 0.15 mg (Auto-Injectors) is supplied with two single-dose pre-filled auto-injectors and one auto-injector trainer device: 0.15 mg/0.3 mL (NDC 0093-5985-27). Epinephrine Injection USP, 0.3 mg 2-Pack and Epinephrine Injection USP, 0.15 mg 2-Pack also includes a W-clip to clip two auto-injectors together. Storage and Handling KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

EPINEPHRINE- EPINEPHRINE INJECTION
TEVA PHARMACEUTICALS USA, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
EPINEPHRINE INJECTION,
0.3 MG AND EPINEPHRINE INJECTION, 0.15 MG SAFELY AND EFFECTIVELY. SEE
FULL PRESCRIBING
INFORMATION FOR EPINEPHRINE INJECTION, 0.3 MG AND EPINEPHRINE
INJECTION, 0.15 MG.
EPINEPHRINE INJECTION, 0.3 MG, FOR INTRAMUSCULAR OR SUBCUTANEOUS USE
EPINEPHRINE INJECTION, 0.15 MG, FOR INTRAMUSCULAR OR SUBCUTANEOUS USE
INITIAL U.S. APPROVAL: 1939
INDICATIONS AND USAGE
Epinephrine Injection, 0.3 mg and Epinephrine Injection, 0.15 mg
contain epinephrine, are 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, 0.3 mg (2)
Patients 15 to 30 kg (33 lbs to 66 lbs): Epinephrine injection, 0.15
mg (2)
Inject intramuscularly or subcutaneously into the anterolateral aspect
of the thigh, through clothing if
necessary. Each device is a single-dose injection. (2)
DOSAGE FORMS AND STRENGTHS
Injection: 0.3 mg (0.3 mg/0.3 mL) single-dose pre-filled auto-injector
(3)
Injection: 0.15 mg (0.15 mg/0.3 mL) single-dose 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, 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 sulfite in this product should not deter use. (5.4)
Administer with caution in patients with heart disease; may aggra