Krajina: Spojené štáty
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
INSULIN HUMAN (UNII: 1Y17CTI5SR) (INSULIN HUMAN - UNII:1Y17CTI5SR)
A-S Medication Solutions
INSULIN HUMAN
INSULIN HUMAN 100 [USP'U] in 1 mL
SUBCUTANEOUS
OTC DRUG
NOVOLIN 70/30 is indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus. Limitations of Use: In NOVOLIN 70/30, the proportions of short-acting and intermediate-acting insulins are fixed and do not allow for basal versus prandial dose adjustments. NOVOLIN 70/30 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
Product: 50090-0403 NDC: 50090-0403-0 10 mL in a VIAL / 1 in a CARTON
Biologic Licensing Application
NOVOLIN 70/30- HUMAN INSULIN INJECTION, SUSPENSION A-S MEDICATION SOLUTIONS ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE NOVOLIN 70/30 SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR NOVOLIN 70/30. NOVOLIN 70/30 (INSULIN ISOPHANE HUMAN AND INSULIN HUMAN) INJECTABLE SUSPENSION, FOR SUBCUTANEOUS USE INITIAL U.S. APPROVAL: 1991 INDICATIONS AND USAGE NOVOLIN 70/30 is a mixture of human insulin isophane, an intermediate-acting human insulin, and human insulin, a short-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) available as: • • CONTRAINDICATIONS • • WARNINGS AND PRECAUTIONS • • • • • • • ADVERSE REACTIONS Adverse reactions observed with NOVOLIN 70/30 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 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT LABELING. REVISED: 2/2023 ® 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 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) Inject NOVOLIN 70/30 subcutaneously approximately 30 minutes prior to start of meal. (2.2) NOVOLIN 70/30 is typically dosed twice daily (with each dose intended to cover 2 meals or a meal and a snack). (2.2) 10 mL multiple-dose vial (3) 3 mL single-patient-use NOVOLIN 70/30 FlexPen prefilled pen (3) During episodes of hypoglycemia (4) Hypersensitiv Prečítajte si celý dokument