EPINEPHRINESNAP-EMS- epinephrine convenience kit kit

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Snap Medical Industries

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Adrenalin ® is available as a single-use 1 mL vial and a multiple-use 30 mL vial for intramuscular and subcutaneous use. Emergency treatment of allergic reactions (Type I), including anaphylaxis, which may result from allergic reactions to insect stings, biting insects, foods, drugs, sera, diagnostic testing substances and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis. The signs and symptoms associated with anaphylaxis include flushing, apprehension, syncope, tachycardia, thready or unobtainable pulse associated with hypotension, convulsions, vomiting, diarrhea and abdominal cramps, involuntary voiding, airway swelling, laryngospasm, bronchospasm, pruritus, urticaria or angioedema, swelling of the eyelids, lips, and tongue. Indicated for patients weighing greater than or equal to 15Kg (33 lbs) None. Teratogenic Effects: Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Epinephrine should be used during pregnancy only if the pote

Produkt oppsummering:

Adrenalin ® 1 mL Single-Use Vials: Each carton contains 25 single-use vials containing 1 mL Adrenalin ® (epinephrine injection, USP) solution 1 mg/mL in a 3 mL clear glass vial. NDC 42023-159-25      1 mL vial Adrenalin ® 30 mL Multi-Dose Vials: Each carton contains 1 multiple-dose vial containing 30 mL Adrenalin ® (epinephrine injection, USP) solution 1 mg/mL in a 36 mL amber glass vial. NDC 42023-168-01      30 mL vial Vial and contents must be discarded 30 days after initial use. Store between 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].  Epinephrine is light sensitive. Protect from light and freezing. Inspect visually for particulate matter and discoloration prior to administration. Do not use the solution if it is colored or cloudy, or if it contains particulate matter.

Autorisasjon status:

New Drug Application

Preparatomtale

EPINEPHRINESNAP-EMS- EPINEPHRINE CONVENIENCE KIT
SNAP MEDICAL INDUSTRIES
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ADRENALIN SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ADRENALIN.
ADRENALIN (EPINEPHRINE INJECTION) 1 MG/ML,
FOR INTRAMUSCULAR AND SUBCUTANEOUS USE
INITIAL U.S. APPROVAL: 1939
RECENT MAJOR CHANGES
Indications and Usage 06/2019
Warnings and Precautions 06/2019
Dosage and Administration 06/2019
INDICATIONS AND USAGE
Adrenalin
is a non-selective alpha and beta adrenergic agonist indicated for:
Emergency treatment of allergic reactions (Type 1), including
anaphylaxis ( 1)
DOSAGE AND ADMINISTRATION
Anaphylaxis:
_Adults and Children 30 kg (66 lbs) or more_: 0.3 to 0.5 mg (0.3 to
0.5 mL) intramuscularly or
subcutaneously into anterolateral aspect of the thigh every 5 to 10
minutes as necessary ( 2)
_Children 30 kg (66 lbs) or less_: 0.01 mg/kg (0.01 mL/kg), up to 0.3
mg (0.3 mL), intramuscularly or
subcutaneously into anterolateral aspect of the thigh every 5 to 10
minutes as necessary ( 2)
DOSAGE FORMS AND STRENGTHS
Injection: 1 mg/mL, 1 mL single-use vials and 30 mL multiple-dose
vials ( 3)
CONTRAINDICATIONS
None ( 4)
WARNINGS AND PRECAUTIONS
Do not inject into buttocks, digits, hands, or feet ( 5.1)
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. ( 5.2)
May aggravate angina pectoris or produce ventricular arrhythmias,
particularly in patients with
underlying heart disease, administer with caution when used
intramuscularly or subcutaneously ( 5.3)
Patients with hyperthyroidism, Parkinson's disease, diabetes, and
pheochromocytoma are at greater
risk of having adverse reactions when used intramuscularly or
subcutaneously ( 5.3)
Presence of sulfite in this product should not deter use for
anaphylaxis ( 5.4)
The Epinephrine does not have markings for doses less than 0.15mL or
0.15m