NOVOLIN R- human insulin injection, solution

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 R is indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus. NOVOLIN R 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 R (insulin human) injection is 100 units/mL (U-100), a clear and colorless solution available as: 10 mL multiple-dose vial NDC 0169-1833-11 ReliOn® brand NDC 0169-1833-02 3 mL single-patient-use FlexPen NDC 0169-3003-15 ReliOn® brand NDC 0169-3003-25 The NOVOLIN R FlexPen dials in 1-unit increments. NOVOLIN R 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 R FlexPen and store without a needle attached. Patients using NOVOLIN R 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 R 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) Intravenous infusion bags prepared as indicated [see Dosage and Administration (2.2)] are stable at room temperature for 24 hours.

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

NOVOLIN R- HUMAN INSULIN INJECTION, SOLUTION
NOVO NORDISK
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
NOVOLIN R SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR NOVOLIN R.
NOVOLIN R (INSULIN HUMAN) INJECTION, FOR SUBCUTANEOUS OR INTRAVENOUS
USE
INITIAL U.S. APPROVAL: 1991
INDICATIONS AND USAGE
NOVOLIN R is 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
Injection: 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 R 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
®
See Full Prescribing Information for important administration
instructions. (2.1)
_Subcutaneous injection:_ inject subcutaneously 30 minutes before a
meal into the abdominal area,
buttocks, thigh or the upper arm. Rotate injection sites to reduce
risk of lipodystrophy and localized
cutaneous amyloidosis. (2.2)
_Intravenous use:_ administer intravenously ONLY under medical
supervision at concentrations from
0.05 unit/mL to 1 unit/mL in infusion systems using polypropylene
infusion bags. (2.2)
Individualize dose based on route of administration, metabolic needs,
blood glucose monitoring
results and glycemic control goal. (2.3)
NOVOLIN R given by subcutaneous injection should generally be used in
regimens with an
intermediate- or long-acting insulin. (2.3)
Can be mixed with NOVOLIN N. (2.5)
10 mL multiple-dose vial (3)
3 mL single-patient-use NOVOLIN R FlexPen prefilled pen (3)
During episodes of hypoglycemia (4)
Hypersensitivity to NOVOLIN R or any of its excipients (4)
Never share a NOVOLIN R FlexPen or syringe between patients, even if
the