NOVOLIN N- human insulin injection, suspension

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

INSULIN HUMAN (UNII: 1Y17CTI5SR) (INSULIN HUMAN - UNII:1Y17CTI5SR)

Dostępny od:

A-S Medication Solutions

INN (International Nazwa):

INSULIN HUMAN

Skład:

INSULIN HUMAN 100 [iU] in 1 mL

Droga podania:

SUBCUTANEOUS

Typ recepty:

OTC DRUG

Wskazania:

NOVOLIN N is indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus. NOVOLIN N is contraindicated: Risk Summary Available data from published studies over decades have not established an association with human insulin use during pregnancy and major birth defects, miscarriage or adverse maternal or fetal outcomes (see Data). There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy (see Clinical Considerations). Animal reproduction studies were not performed. The estimated background risk of major birth defects is 6-10% in women with pre-gestational diabetes with a HbA1c >7 and has been reported to be as high as 20-25% in women with a HbA1c >10. The estimated background risk of miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Clinical Considerations Diseas

Podsumowanie produktu:

Product: 50090-0498 NDC: 50090-0498-0 10 mL in a VIAL / 1 in a CARTON

Status autoryzacji:

Biologic Licensing Application

Charakterystyka produktu

NOVOLIN N- HUMAN INSULIN INJECTION, SUSPENSION
A-S MEDICATION SOLUTIONS
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
NOVOLIN N SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR NOVOLIN N.
NOVOLIN N (INSULIN ISOPHANE HUMAN) INJECTABLE SUSPENSION, FOR
SUBCUTANEOUS USE
INITIAL U.S. APPROVAL: 1991
INDICATIONS AND USAGE
NOVOLIN N is an intermediate-acting human insulin indicated to improve
glycemic control in adults and
pediatric patients with diabetes mellitus. (1)
DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
Injectable suspension: 100 units/mL (U-100) is available as:
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CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
Adverse reactions observed with NOVOLIN N include hypoglycemia,
allergic reactions, injection site
reactions, lipodystrophy, weight gain and edema. (6)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT NOVO NORDISK INC. AT
1-800-727-6500 OR
FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
®
See Full Prescribing Information for important administration
instructions. (2.1)
Inject subcutaneously in abdominal wall, thigh, upper arm, or buttocks
and rotate injection sites to
reduce the risk of lipodystrophy and localized cutaneous amyloidosis.
(2.1)
Individualize and adjust dosage based on metabolic needs, blood
glucose monitoring results and
glycemic control goal. (2.2)
Administer NOVOLIN N once or twice daily. (2.2)
In patients with type 1 diabetes, NOVOLIN N should generally be used
in regimens that include a
short-acting insulin. (2.2)
NOVOLIN N can be mixed with NOVOLIN R. (2.4)
10 mL multiple-dose vial (3)
3 mL single-patient-use NOVOLIN N FlexPen prefilled pen (3)
During episodes of hypoglycemia (4)
Hypersensitivity to NOVOLIN N or any of its excipients (4)
Never share a NOVOLIN N FlexPen or syringe between patients, even if
the needle is changed. (5.1)
_Hyperglycemia or Hypoglycemia with Changes in Insulin Regimen:_ Make