FIASP- insulin aspart injection injection, solution FIASP- insulin aspart injection, solution

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

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

متاح من:

Novo Nordisk

INN (الاسم الدولي):

INSULIN ASPART

تركيب:

INSULIN ASPART 100 [iU] in 1 mL

طريقة التعاطي:

SUBCUTANEOUS

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

FIASP is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. FIASP is contraindicated: Risk Summary There are no available data with FIASP 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 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 1.0 unit/kg/day, respectively. Pre- and post-implantation losses and visceral/skeletal abnormalities were seen a

ملخص المنتج:

FIASP (insulin aspart) injection 100 units of insulin aspart per mL (U-100) is available as a clear and colorless solution in the following presentations and packaging configurations: Dispense in the original sealed carton with the enclosed Instructions for Use. Unused FIASP vials should be stored between 2° to 8°C (36° to 46°F) in a refrigerator, but not in or near a freezing compartment. FIASP should not be exposed to excessive heat or light and must never be frozen. Do not use FIASP if it has been frozen. FIASP should not be drawn into a syringe and stored for later use. Keep the cap on the pen in order to protect from light. Remove the needle from the FIASP FlexTouch pen after each injection and store without a needle attached. Use a new needle for each injection. Keep unused vials, FIASP FlexTouch, PenFill Cartridges and PumpCart cartridges in the carton so they will stay clean and protected from light. The storage conditions for vials, FIASP FlexTouch pens, 3 mL PenFill cartridges and 1.6 mL PumpCart cartridges are summarized in Table 12: Table 12. Storage Conditions for Vial, FIASP FlexTouch, PenFill Cartridges and PumpCart Cartridges FIASP presentation Not in-use (unopened) In-use (opened) Room Temperature (up to 30°C [86°F]) Refrigerated (2°C to 8°C [36°F to 46°F]) Room Temperature (up to 30°C [86°F]) Refrigerated (2°C to 8°C [36°F to 46°F]) 10 mL multiple-dose vial 28 days Until expiration date 28 days* (up to 30°C [86°F]) 28 days* 3 mL single-patient-use FIASP FlexTouch pen 28 days Until expiration date 28 days (up to 30°C [86°F]) 28 days 3 mL single-patient-use PenFill cartridges 28 days Until expiration date 28 days (up to 30°C [86°F]) Do not refrigerate 1.6 mL single-patient-use PumpCart cartridges 18 days** Until expiration date 4 days** (up to 37°C [98.6°F]) Do not refrigerate *Pump Reservoir: The total in use time is 28 days, including 6 days in the pump reservoir **PumpCart Cartridges: The maximum time at room temperature is 18 days including 4 days in the pump Storage of FIASP in Insulin Pump: Storage of FIASP in Intravenous Infusion Fluids: Infusion bags prepared as indicated under Dosage and Administration (2.2) are stable at room temperature at 20°C to 25°C (68°F to 77°F) for 24 hours.

الوضع إذن:

Biologic Licensing Application

خصائص المنتج

FIASP- INSULIN ASPART INJECTION INJECTION, SOLUTION
NOVO NORDISK
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FIASP SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR FIASP.
FIASP (INSULIN ASPART) INJECTION, FOR SUBCUTANEOUS OR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2000
INDICATIONS AND USAGE
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DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
Injection: 100 units/mL (U-100) available as:
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CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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®
FIASP is a rapid-acting human insulin analog indicated to improve
glycemic control in adult and
pediatric patients with diabetes mellitus (1).
Individualize and adjust the dosage of FIASP based on route of
administration, individual’s metabolic
needs, blood glucose monitoring results and glycemic control goal
(2.3).
Dosage adjustments may be needed when switching from another insulin,
with changes in physical
activity, changes in concomitant medications, changes in meal
patterns, changes in renal or hepatic
function or during acute illness (2.3).
_Subcutaneous injection (_2.2_):_
o
o
o
Inject at the start of a meal or within 20 minutes after starting a
meal into the abdomen, upper
arm, or thigh.
Rotate injection sites within the same region to reduce the 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):
o
o
Refer to the insulin infusion pump user manual to see if FIASP can be
used. Use in accordance
with the insulin pumps’ instructions for use.
Administer by continuous subcutaneous infusion using an insulin pump
in a region recommended
in the instructions from the pump manufacturer. Rotate infusion sites
within the same region to
reduce the risk of lipodystrophy and localized cutaneous amyloidosis.
_Intravenous Infusion:_ Administer only under medical supervision
after diluting to concentrations