INSULIN ASPART injection, solution

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

Novo Nordisk Pharma, Inc.

Administreringssätt:

INTRAVENOUS

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

Insulin Aspart is indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus. Insulin Aspart is contraindicated: Risk Summary 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 and rabbits during the period of organogenesis did not cause adverse developmental effects at exposures 8-times and equal to the human subcutaneous dose of 1 unit/kg/day, respectively. Pre- and post-implantation losses and visceral/skeletal abnormalities were seen at higher exposures, which are considered secondary to maternal hypoglycemia. These effects were similar to those o

Produktsammanfattning:

Insulin Aspart injection 100 units/mL (U-100) is available as a clear and colorless solution in: One 10 mL multiple-dose vial per carton NDC 73070-100-11 Five 3 mL single-patient-use PenFill prefilled cartridges* per carton NDC 73070-102-15 Five 3 mL single-patient-use FlexPen prefilled pens per carton NDC 73070-103-15 *Insulin Aspart PenFill cartridges are designed for use with compatible insulin delivery devices with NovoFine disposable needles. FlexPen can be used with NovoFine or NovoTwist disposable needles. The Insulin Aspart FlexPen dials in 1-unit increments. Dispense in the original sealed carton with the enclosed Instructions for Use. Store unused Insulin Aspart in a refrigerator between 2°C to 8°C (36°F to 46°F).  Do not freeze Insulin Aspart and do not  use Insulin Aspart if it has been frozen. Do not expose Insulin Aspart to excessive heat or light. Do not withdraw Insulin Aspart into a syringe and store for later use. Always remove and discard the needle after each injection from the Insulin Aspart FlexPen and store without a needle attached. The storage conditions are summarized in the following table: Table 9. Storage Conditions for vial, PenFill cartridges, and Insulin Aspart FlexPen Insulin Aspart presentation 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 PenFill cartridges 28 days Until expiration date 28 days (Do not refrigerate) 3 mL single-patient-use FlexPen 28 days Until expiration date 28 days (Do not refrigerate) *For insulin pump use, the total in-use time is 19 days, including 7 days pump in-use time. Storage in External Insulin Pump: Change the Insulin Aspart in the pump reservoir at least every 7 days or in accordance to the pump user manual, whichever is shorter, or after exposure to temperatures that exceed 37°C (98.6°F). Storage of Diluted Insulin Aspart This Insulin Aspart product diluted with Insulin Diluting Medium for NovoLog (insulin aspart) to a concentration equivalent to U-10 or equivalent to U-50 prepared as indicated under Dosage and Administration (2.2) may remain in patient use at temperatures up to 30°C (86°F) for 28 days. Storage of Insulin Aspart in Intravenous Infusion Fluids Infusion bags prepared as indicated under Dosage and Administration (2.2) are stable at room temperature for 24 hours. Some insulin will be initially adsorbed to the material of the infusion.

Bemyndigande status:

Biologic Licensing Application

Produktens egenskaper

INSULIN ASPART- INSULIN ASPART INJECTION, SOLUTION
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 SAFELY
AND EFFECTIVELY.
SEE FULL PRESCRIBING INFORMATION FOR INSULIN ASPART.
INSULIN ASPART INJECTION, FOR SUBCUTANEOUS OR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2000
THIS PRODUCT IS NOVOLOG (INSULIN ASPART).
INDICATIONS AND USAGE
Insulin Aspart is rapid acting human insulin analog indicated to
improve glycemic control in adults and
pediatric patients with diabetes mellitus (1).
DOSAGE AND ADMINISTRATION
See Full Prescribing Information for important preparation,
administration, and dosage instructions (2.1,
2.2, 2.3, 2.4, 2.5).
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DOSAGE FORMS AND STRENGTHS
Injection: 100 units/mL (U-100) of insulin aspart available as:
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CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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_Subcutaneous injection (2.2):_
Inject subcutaneously within 5-10 minutes before a meal into the
abdominal area, thigh, buttocks or
upper arm.
Rotate injection sites within the same region from one injection to
the next to reduce risk of
lipodystrophy and localized cutaneous amyloidosis.
Should generally be used in regimens with an intermediate- or
long-acting insulin.
_Continuous Subcutaneous Infusion (Insulin Pump) (2.2):_
Refer to the insulin infusion pump user manual to see if NovoLog
(insulin aspart) can be used. Use in
accordance with the insulin pump instructions for use.
Administer by continuous subcutaneous infusion using an insulin pump
in a region recommended in
the instructions from the pump manufacturer.
Rotate the injection sites within the same region from one injection
to the next to reduce the risk of
lipodystrophy and localized cutaneous amyloidosis.
Do not mix with other insulins or diluents in the pump.
_Intravenous Administration (2.2)_:
Dilute Insulin Aspart to concentrations from 0.05 unit/mL to 1 unit/mL
insulin aspart in infusion
systems using polypropylene infusio