NOVOLIN 70/30- human insulin injection, suspension

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

A-S Medication Solutions

INN (Διεθνής Όνομα):

INSULIN HUMAN

Σύνθεση:

INSULIN HUMAN 100 [USP'U] in 1 mL

Οδός χορήγησης:

SUBCUTANEOUS

Τρόπος διάθεσης:

OTC DRUG

Θεραπευτικές ενδείξεις:

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

Περίληψη προϊόντος:

Product: 50090-0403 NDC: 50090-0403-0 10 mL in a VIAL / 1 in a CARTON

Καθεστώς αδειοδότησης:

Biologic Licensing Application

Αρχείο Π.Χ.Π.

NOVOLIN 70/30- 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 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
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DOSAGE FORMS AND STRENGTHS
Injectable suspension: 100 units/mL (U-100) 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 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
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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