Држава: Сједињене Америчке Државе
Језик: Енглески
Извор: NLM (National Library of Medicine)
INSULIN HUMAN (UNII: 1Y17CTI5SR) (INSULIN HUMAN - UNII:1Y17CTI5SR)
A-S Medication Solutions
INSULIN HUMAN
INSULIN HUMAN 100 [iU] in 1 mL
SUBCUTANEOUS
OTC DRUG
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
Product: 50090-0498 NDC: 50090-0498-0 10 mL in a VIAL / 1 in a CARTON
Biologic Licensing Application
NOVOLIN N- HUMAN INSULIN INJECTION, SUSPENSION A-S MEDICATION SOLUTIONS ---------- 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 • • • • • • DOSAGE FORMS AND STRENGTHS Injectable suspension: 100 units/mL (U-100) is available as: • • CONTRAINDICATIONS • • WARNINGS AND PRECAUTIONS • • • • • • • 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 Прочитајте комплетан документ