NOVOLIN N- human insulin injection, suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Novo Nordisk

INN (International Name):

INSULIN HUMAN

Composition:

INSULIN HUMAN 100 [iU] in 1 mL

Administration route:

SUBCUTANEOUS

Prescription type:

OTC DRUG

Therapeutic indications:

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 summary:

NOVOLIN N (insulin isophane human) injectable suspension, 100 units/mL (U-100), is a white and cloudy suspension available as: 10 mL multiple-dose vial NDC 0169-1834-11 ReliOn® brand NDC 0169-1834-02 3 mL single-patient-use FlexPen prefilled pen NDC 0169-3004-15 ReliOn® brand NDC 0169-3004-25 The NOVOLIN N FlexPen dials in 1-unit increments. Dispense in the original sealed carton with the enclosed Instructions for Use. Do not expose NOVOLIN N vials and NOVOLIN N FlexPen to excessive heat or light. Do not freeze. Do not use after the expiration date. NOVOLIN N FlexPen must never be shared between patients, even if the needle is changed. Always remove and discard the needle after each injection from the NOVOLIN N FlexPen and store without a needle attached. Patients using NOVOLIN N vials must never share needles or syringes with another person. Always use a new disposable syringe or needle for each injection to prevent contamination. Table 2: Storage Conditions and Expiration Dates for NOVOLIN N Not In-use (Unopened) Refrigerated (36°F - 46°F [2°C - 8°C]) Not In-use (Unopened) Room Temperature (see temperature below) In-use (Opened) Room Temperature (see temperature below) 10 mL multiple-dose vial Until expiration date 42 days up to 77°F (25°C) 42 days up to 77°F (25°C) (Do not refrigerate) 3 mL single-patient-use FlexPen Until expiration date 28 days up to 86°F (30°C) 28 days up to 86°F (30°C) (Do not refrigerate)

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

NOVOLIN N- HUMAN INSULIN INJECTION, SUSPENSION
NOVO NORDISK
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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
changes to a