INSULIN ASPART PROTAMINE AND INSULIN ASPART MIX 70/30- insulin aspart injection, suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

INSULIN ASPART (UNII: D933668QVX) (insulin aspart - UNII:D933668QVX)

Available from:

Novo Nordisk Pharma, Inc.

Administration route:

SUBCUTANEOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Insulin Aspart Protamine and Insulin Aspart Mix 70/30 is a mixture of insulin aspart protamine and insulin aspart indicated to improve glycemic control in adult patients with diabetes mellitus. Limitations of Use: Insulin Aspart Protamine and Insulin Aspart Mix 70/30 is contraindicated: Risk Summary There are no available data with Insulin Aspart Protamine and Insulin Aspart Mix 70/30 (referred to as Insulin Aspart Protamine and Insulin Aspart ) in pregnant women to inform a drug-associated risk for major birth defects and miscarriage. Available information from published randomized controlled trials with insulin aspart use during the second trimester of pregnancy have not reported an association with insulin aspart and major birth defects 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] . In animal reproduction studies, administration of subcutaneous insulin aspart to pregnant rats

Product summary:

One 10 mL multiple-dose vial per carton NDC 73070-200-11 Five 3 mL single-patient-use FlexPen prefilled pens per carton NDC 73070-203-15 Dispense in the original sealed carton with the enclosed Instructions for Use. Store unused Insulin Aspart Protamine and Insulin Aspart in a refrigerator between 2°C to 8°C (36°F to 46°F). Do not freeze Insulin Aspart Protamine and Insulin Aspart or use Insulin Aspart Protamine and Insulin Aspart if it has been frozen. Do not expose Insulin Aspart Protamine and Insulin Aspart to excessive heat or light. Always remove the needle after each injection and store Insulin Aspart Protamine and Insulin Aspart FlexPen without a needle attached. The storage conditions are summarized in the following table: Table 7: Storage conditions for Insulin Aspart Protamine and Insulin Aspart Mix 70/30 vial and FlexPen Not in-use (unopened) Room Temperature (up to 30°C [86°F]) Not in-use (unopened) Refrigerated (2°C to 8°C [36°F to 46°F]) In-use (opened) Room Temperature (up to 30°C [86°F]) 10 mL multiple-dose vial 28 days Until expiration date 28 days (refrigerated/room temperature) 3 mL single-patient-use FlexPen 14 days Until expiration date 14 days (Do not refrigerate)

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

INSULIN ASPART PROTAMINE AND INSULIN ASPART MIX 70/30- INSULIN
ASPART INJECTION, SUSPENSION
NOVO NORDISK PHARMA, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
INSULIN ASPART
PROTAMINE AND INSULIN ASPART MIX 70/30 SAFELY AND EFFECTIVELY. SEE
FULL PRESCRIBING
INFORMATION FOR INSULIN ASPART PROTAMINE AND INSULIN ASPART MIX 70/30.
INSULIN ASPART PROTAMINE AND INSULIN ASPART MIX 70/30 INJECTABLE
SUSPENSION, FOR
SUBCUTANEOUS USE
INITIAL U.S. APPROVAL: 2001
THIS PRODUCT IS NOVOLOG MIX 70/30 (INSULIN ASPART PROTAMINE AND
INSULIN ASPART).
INDICATIONS AND USAGE
Insulin Aspart Protamine and Insulin Aspart Mix 70/30 is a mixture of
insulin aspart protamine, an
intermediate-acting human insulin analog, and insulin aspart, a
rapid-acting human insulin analog,
indicated to improve glycemic control in adult patients with diabetes
mellitus.
Limitations of Use:
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DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
Injectable suspension: 100 units/mL (U-100) of Insulin Aspart
Protamine and Insulin Aspart Mix 70/30, 70%
insulin aspart protamine and 30% insulin aspart available as:
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CONTRAINDICATIONS
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Not recommended for the treatment of diabetic ketoacidosis.
The proportions of rapid-acting and long-acting insulins are fixed and
do not allow for basal versus
prandial dose adjustments (1).
Inspect visually before use. Appearance should be uniformly white and
cloudy. Do not use it if it looks
clear or if it contains solid particles (2.1).
Insulin Aspart Protamine and Insulin Aspart Mix 70/30 must be
resuspended immediately before use.
Resuspension is easier when the insulin has reached room temperature
(2.1).
Inject Insulin Aspart Protamine and Insulin Aspart Mix 70/30
subcutaneously in the abdominal region,
buttocks, thigh, or upper arm (2.1).
Administer the dose within 15 minutes before meal initiation. For
patients with type 2 diabetes, the
dose may also be given after meal initiation (2.1).
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