GLUCAGEN- glucagon hydrochloride kit GLUCAGEN- glucagon hydrochloride injection, powder, for solution

Држава: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

GLUCAGON HYDROCHLORIDE (UNII: 1H87NVF4DB) (glucagon - UNII:76LA80IG2G)

Доступно од:

Boehringer Ingelheim Pharmaceuticals, Inc.

INN (Међународно име):

GLUCAGON HYDROCHLORIDE

Састав:

glucagon 1 mg in 1 mL

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

GlucaGen is indicated for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes. GlucaGen is indicated as a diagnostic aid for use during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract in adult patients. GlucaGen is contraindicated in patients with: Risk Summary Available data from case reports and a small number of observational studies with glucagon use in pregnant women over decades of use have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Multiple small studies have demonstrated a lack of transfer of pancreatic glucagon across the human placental barrier during early gestation. In rat and rabbit reproduction studies, no embryofetal toxicity was observed with glucagon administered by injection during the period of organogenesis at doses representing up to 100 and 200 times the human dose, respectively, based on body surface area (mg/m2 ) (see Data). The estimated background

Резиме производа:

GlucaGen for injection is supplied as a lyophilized white powder available as follows: Presentation NDC Strength Description Treatment of Severe Hypoglycemia GlucaGen HypoKit 0169-7065-15 1 mg per vial 1 mL single-dose vial of GlucaGen with 1 mL single-dose syringe of Sterile Water for Injection, USP for reconstitution Use as a Diagnostic Aid GlucaGen 10-pack: 10 Single-dose vials 0597-0053-45 1 mg per vial 1 mL single-dose vial of GlucaGen GlucaGen Diagnostic Kit 0597-0260-10 1 mg per vial 1 mL single-dose vial of GlucaGen with 1 mL single-dose vial of Sterile Water for Injection, USP for reconstitution Before Reconstitution: The GlucaGen package may be stored up to 24 months at controlled room temperature 20o to 25o C (68o to 77o F) prior to reconstitution. Do not freeze. Keep in the original package to protect from light. After Reconstitution: Use the reconstituted GlucaGen solution immediately. Discard any unused portion [see Dosage and Administration (2)].

Статус ауторизације:

New Drug Application

Карактеристике производа

GLUCAGEN- GLUCAGON HYDROCHLORIDE
GLUCAGEN- GLUCAGON HYDROCHLORIDE INJECTION, POWDER, FOR SOLUTION
BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
GLUCAGEN SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR GLUCAGEN.
GLUCAGEN (GLUCAGON) FOR INJECTION, FOR SUBCUTANEOUS, INTRAMUSCULAR OR
INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1960
RECENT MAJOR CHANGES
Dosage and Administration
(2)--------------------------------------------03/2021
Contraindications
(4)--------------------------------------------------------03/2021
Warnings and Precautions (5.1, 5.2, 5.3, 5.4, 5.6, 5.7,
5.8)------------03/2021
INDICATIONS AND USAGE
GlucaGen is an antihypoglycemic agent and a gastrointestinal motility
inhibitor indicated:
•
•
DOSAGE AND ADMINISTRATION
Dosage in adults and pediatric patients using the GlucaGen HypoKit to
treat severe hypoglycemia (2.2)
•
•
Important Administration Instructions for Using the GlucaGen HypoKit
to Treat Severe Hypoglycemia (2.1)
•
•
Dosage in Adults for Using GlucaGen Diagnostic Kit and GlucaGen
10-pack as a Diagnostic Aid (2.4)
•
•
DOSAGE FORMS AND STRENGTHS
®
for the treatment of severe hypoglycemia in pediatric and adult
patients with diabetes (1.1)
as a diagnostic aid for use during radiologic examinations to
temporarily inhibit movement of the
gastrointestinal tract in adult patients (1.2)
Adults and Pediatric Patients Weighing 25 kg or More or for Pediatric
Patients with Unknown Weight 6
Years and Older:
-The recommended dosage is 1 mg (1 mL) injected subcutaneously or
intramuscularly into the upper
arm, thigh, or buttocks, or intravenously.
-If there has been no response after 15 minutes, an additional 1 mg
dose (1 mL) of GlucaGen may be
administered using a new kit while waiting for emergency assistance.
Pediatric Patients Weighing Less Than 25 kg or for Pediatric Patients
with Unknown Weight Less Than 6
Years of Age:
-The recommended dosage is 0.5 mg (0.5 mL) inj