EPINEPHRINE CONVENIENCE KIT- epinephrine kit

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

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

Dostupné s:

HF Acquisition Co LLC, DBA HealthFirst

Podání:

INTRAMUSCULAR

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

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. None. 8.1 Pregnancy 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 potential benefit justifies the potential risk to the fetus (fetal

Přehled produktů:

Epinephrine Convenience Kit is supplied in the following dosage forms. NDC 51662-1507-1 (Epinephrine Convenience Kit) Kit Contains: Item #1007670-ADRENALIN® (EPINEPHRINE INJECTION, USP) 1mg/mL 1:1000 VIAL, NDC 51662-1290-1, 2 Total Item # 6985-EpiRite Syringe, 2 Total Item # 1005310-Needle 20Gx1 1/2", 2 Total N/A-Alcohol Prep Pad, 2 Total N/A- Package Insert, 1 Total HF Acquisition Co LLC, DBA HealthFirst Mukilteo, WA 98275 Adrenalin® 1 mL Single-Use Vials: 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.

Stav Autorizace:

New Drug Application

Informace pro uživatele

EPINEPHRINE CONVENIENCE KIT- EPINEPHRINE
HF Acquisition Co LLC, DBA HealthFirst
----------
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, subcutaneous, and intravenous use
Initial U.S. Approval: 1939
RECENT MAJOR CHANGES
Indications and Usage (1.2) 01/2019
Dosage and Administration (2.3) 01/2019
Warnings and Precautions (5.3, 5.4, 5.5, 5.6, 5.7) 01/2019
INDICATIONS AND USAGE
Adrenalin® is a non-selective alpha and beta adrenergic agonist
indicated for:
Emergency treatment of allergic reactions (Type 1), including
anaphylaxis ( 1-1.1)
To increase mean arterial blood pressure in adult patients with
hypotension associated with septic shock (
1-1.2)
DOSAGE AND ADMINISTRATION
Anaphylaxis:
Adults and Children 30 kg (66 lbs) or more: 0.3 mg to 0.5 mg (0.3 mL
to 0.5 mL) intramuscularly or
subcutaneously into anterolateral aspect of the thigh every 5 to 10
minutes as necessary ( 2-2.2)
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 ( 2-2.2)
Hypotension associated with septic shock:
Dilute epinephrine in dextrose solution prior to infusion ( 2-2.3)
Infuse epinephrine into a large vein ( 2-2.3)
Intravenous infusion rate of 0.05 mcg/kg/min to 2 mcg/kg/min, titrated
to achieve desired mean arterial
pressure ( 2-2.3)
Wean gradually ( 2-2.3)
See Full Prescribing Information for instructions on dilution and
administration of the injection.
DOSAGE FORMS AND STRENGTHS
Injection: 1 mg/mL single dose vial and 30 mg/30 mL (1 mg/mL) multiple
dose vial ( 3)
CONTRAINDICATIONS
None ( 4)
WARNINGS AND PRECAUTIONS
Do not inject into buttocks, digits, hands, or feet ( 5-5.1)
Avoid extravasation into tissues, which can cause local necrosis (
5-5.3)
May aggravate angina pectoris or produce ventricular arrh

Charakteristika produktu

EPINEPHRINE CONVENIENCE KIT- EPINEPHRINE
HF ACQUISITION CO LLC, DBA HEALTHFIRST
----------
EPINEPHRINE CONVENIENCE KIT
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, subcutaneous, and intravenous use
Initial U.S. Approval: 1939
RECENT MAJOR CHANGES
Indications and Usage (1.2) 01/2019
Dosage and Administration (2.3) 01/2019
Warnings and Precautions (5.3, 5.4, 5.5, 5.6, 5.7) 01/2019
INDICATIONS AND USAGE
Adrenalin® is a non-selective alpha and beta adrenergic agonist
indicated for:
Emergency treatment of allergic reactions (Type 1), including
anaphylaxis ( 1-1.1)
To increase mean arterial blood pressure in adult patients with
hypotension associated with septic shock
( 1-1.2)
DOSAGE AND ADMINISTRATION
Anaphylaxis:
Adults and Children 30 kg (66 lbs) or more: 0.3 mg to 0.5 mg (0.3 mL
to 0.5 mL) intramuscularly or
subcutaneously into anterolateral aspect of the thigh every 5 to 10
minutes as necessary ( 2-2.2)
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 ( 2-2.2)
Hypotension associated with septic shock:
Dilute epinephrine in dextrose solution prior to infusion ( 2-2.3)
Infuse epinephrine into a large vein ( 2-2.3)
Intravenous infusion rate of 0.05 mcg/kg/min to 2 mcg/kg/min, titrated
to achieve desired mean arterial
pressure ( 2-2.3)
Wean gradually ( 2-2.3)
See Full Prescribing Information for instructions on dilution and
administration of the injection.
DOSAGE FORMS AND STRENGTHS
Injection: 1 mg/mL single dose vial and 30 mg/30 mL (1 mg/mL) multiple
dose vial ( 3)
CONTRAINDICATIONS
None ( 4)
WARNINGS AND PRECAUTIONS
Do not inject into buttocks, digits, hands, or feet ( 5-5.1)
Avoid extravasation into tissues, which can cause local necrosis (
5-5.3)
May aggravate angina pectoris