EPIPEN- epinephrine injection EPIPEN JR- epinephrine injection

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

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

Sẵn có từ:

TYA Pharmaceuticals

INN (Tên quốc tế):

EPINEPHRINE

Thành phần:

EPINEPHRINE 0.3 mg in 0.3 mL

Tuyến hành chính:

INTRAMUSCULAR

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

EpiPen and EpiPen Jr 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. EpiPen and EpiPen Jr 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, wheezing, dyspnea due to laryngeal spasm, pruritus, rashes, urticaria or angioedema. EpiPen an

Tóm tắt sản phẩm:

NDC:64725-0500-1 in a CARTON of 1 INJECTIONS EpiPen Auto-Injectors (epinephrine injections, USP, 1:1000, 0.3 mL) are available as EpiPen 2-Pak , NDC 49502-500-02, a pack that contains two EpiPen Auto-Injectors (epinephrine injections, USP, 1:1000, 0.3 mL) and one EpiPen Auto-Injector trainer device. ® EpiPen Jr Auto-Injectors (epinephrine injections, USP, 1:2000, 0.3 mL) are available as EpiPen Jr 2-Pak , NDC 49502-501-02, a pack that contains two EpiPen Jr Auto-Injectors (epinephrine injections, USP, 1:2000, 0.3 mL) and one EpiPen Auto-Injector trainer device. ® EpiPen 2-Pak and EpiPen Jr 2-Pak also includes an S-clip to clip two carrier tubes together. ® ® Rx only Protect from light. Epinephrine is light sensitive and should be stored in the carrier tube provided to protect it from light. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) (See USP Controlled Room Temperature). Do not refrigerate. Before using, check to make sure the solution in the auto-injector is clear and colorless. Replace the auto-injector if the solution is discolored (pinkish or brown color), cloudy, or contains particles.

Tình trạng ủy quyền:

New Drug Application

Đặc tính sản phẩm

EPIPEN- EPINEPHRINE INJECTION
EPIPEN JR- EPINEPHRINE INJECTION
TYA PHARMACEUTICALS
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR . INITIAL U.S. APPROVAL: 1939 EPIPEN AND EPIPEN JR
EPIPEN AND EPIPEN JR
EPIPEN (EPINEPHRINE INJECTION), AUTO-INJECTOR 0.3 MG, EPIPEN JR
(EPINEPHRINE INJECTION) AUTO-INJECTOR 0.15
MG, FOR INTRAMUSCULAR OR SUBCUTANEOUS USE
INDICATIONS AND USAGE
EpiPen and EpiPen Jr contain 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
•
•
Inject EpiPen and EpiPen Jr 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
•
•
CONTRAINDICATIONS
None ( ) 4
WARNINGS AND PRECAUTIONS
•
•
•
•
ADVERSE REACTIONS
Adverse reactions to epinephrine include anxiety, apprehensiveness,
restlessness, tremor, weakness, dizziness, sweating,
palpitations, pallor, nausea and vomiting, headache, and/or
respiratory difficulties. ( ) 6
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACTMYLAN SPECIALTY, L.P. AT
1-877-446-3679 (1-877-4-INFO-
RX)OR FDA AT 1-800-FDA-1088 ORwww.fda.gov/medwatch.
DRUG INTERACTIONS
•
•
•
•
•
USE IN SPECIFIC POPULATIONS
•
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
REVISED: 10/2014
® ®
® ®
Patients greater than or equal to 30 kg (66 lbs): EpiPen 0.3 mg ( ) 2
Patients 15 to 30 kg (33 lbs to 66 lbs): EpiPen Jr 0.15 mg ( ) 2
EpiPen: Injection, 0.3 mg: 0.3 mg/0.3 mL epinephrine, USP, pre-filled
auto-injector ( ) 3
EpiPen Jr: Injection, 0.15 mg: 0.15 mg/0.3 mL epinephrine, USP,
pre-filled auto-injector ( ) 3
In conjunction with use, seek immediate medical or hospital care. ( )
5.1
Do not inject intravenously, into buttock, or into digits, hands, or
fee