GLUCAGON injection, powder, lyophilized, for solution GLUCAGON kit

Country: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

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

Fáanlegur frá:

Fresenius Kabi USA, LLC

Stjórnsýsluleið:

INTRAVENOUS

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

Glucagon for Injection is indicated for use as a diagnostic aid during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract.        Limitations of Use :  Glucagon for Injection is not indicated for the emergency treatment of hypoglycemia because it is not packaged with a syringe and diluent necessary for rapid preparation and administration during an emergency outside of a healthcare facility. Glucagon for Injection is contraindicated in patients with: - Pheochromocytoma [see Warnings and Precautions (5.1)] because of the risk of increased blood pressure - Insulinoma [see Warnings and Precautions (5.2)] because of the risk of hypoglycemia - Glucagonoma [see Warnings and Precautions (5.2)] because of the risk of hypoglycemia Pregnancy Category B.  Reproduction studies were performed in rats and rabbits with another glucagon product at doses of 0.4, 2, and 10 mg per kg.  These doses represent exposures of up to 100 and 200 times the human dose based on mg/m2 for rats and rab

Vörulýsing:

Glucagon for Injection is supplied as a sterile, lyophilized white powder in a vial.     The container closure is not made with natural rubber latex. Before Reconstitution   The package containing Glucagon for Injection vials may be stored up to 24 months at 20° to 25° C (68°   to 77°   F) [see USP Controlled Room Temperature] prior to reconstitution.  Do not freeze.  Keep in the original package to protect from light.  After Reconstitution   The Glucagon for Injection must be reconstituted with Sterile Water for Injection prior to use.  Use reconstituted glucagon solution immediately.  Discard any unused portion [see Dosage and Administration (2.3)] .

Leyfisstaða:

New Drug Application

Vara einkenni

GLUCAGON - GLUCAGON INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
GLUCAGON- GLUCAGON
FRESENIUS KABI USA, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
GLUCAGON FOR
INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
GLUCAGON FOR
INJECTION.
GLUCAGON FOR INJECTION, FOR INTRAVENOUS OR INTRAMUSCULAR USE
INITIAL U.S. APPROVAL: 1998
INDICATIONS AND USAGE
Glucagon for Injection is a gastrointestinal motility inhibitor
indicated for use as a diagnostic aid during
radiologic examinations to temporarily inhibit movement of the
gastrointestinal (GI) tract (1)
Limitations of Use:
Glucagon for Injection is not indicated for the emergency treatment of
hypoglycemia (1)
DOSAGE AND ADMINISTRATION
Reconstitute lyophilized powder with Sterile Water for Injection
before use (2.2, 2.3)
Determine dose based on diagnostic procedure, route of administration
and procedure duration (2.1):
To inhibit stomach and small bowel motility the dose is 0.2 mg to 0.5
mg given intravenously or 1
mg given intramuscularly
To inhibit colon motility the dose is 0.5 mg to 0.75 mg given
intravenously or 1 mg to 2 mg given
intramuscularly
DOSAGE FORMS AND STRENGTHS
For Injection: 1 mg lyophilized powder in single dose vial for
reconstitution (3)
CONTRAINDICATIONS
Pheochromocytoma (4, 5.1)
Insulinoma (4, 5.2)
Glucagonoma (4, 5.2)
WARNINGS AND PRECAUTIONS
Hyperglycemia in patients with diabetes: Monitor blood glucose and
treat with insulin if indicated (5.3)
Increased blood pressure and heart rate in patients with cardiac
disease: Monitor patients with known
cardiac disease (5.4)
Allergic reactions including anaphylactic shock with breathing
difficulties, and hypotension, generalized
rash: Discontinue and treat as indicated (5.5)
ADVERSE REACTIONS
Adverse reactions seen with glucagon are transient changes in blood
pressure, increase in heart rate,
hypersensitivity reactions, nausea and vomiting, and hypoglycemia (6)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT FRESEN