INSULIN LISPRO injection, solution

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

INSULIN LISPRO (UNII: GFX7QIS1II) (INSULIN LISPRO - UNII:GFX7QIS1II)

Tilgængelig fra:

REMEDYREPACK INC.

Indgivelsesvej:

INTRAVENOUS

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

Insulin Lispro Injection is a rapid acting human insulin analog indicated to improve glycemic control in adults and children with diabetes mellitus. Insulin Lispro Injection is contraindicated: - during episodes of hypoglycemia - in patients who are hypersensitive to Insulin Lispro Injection or to any of its excipients. Risk Summary The limited available data with Insulin Lispro Injection in pregnant women are insufficient to inform a drug-associated risk of adverse developmental outcomes. Published studies with insulin lispro used during pregnancy have not reported an association between insulin lispro and the induction of 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) . Pregnant rats and rabbits were exposed to insulin lispro in animal reproduction studies during organogenesis. No adverse effects on embryo/fetal

Produkt oversigt:

Insulin Lispro Injection is a clear and colorless solution available as: NDC: 70518-2398-00 PACKAGING: 1 in 1 CARTON, 10 mL in 1 VIAL TYPE 0 The Insulin Lispro Injection KwikPen dials in 1 unit increments. The Insulin Lispro Injection Junior KwikPen dials in 0.5 unit increments. Each prefilled pen is for single-patient-use only. Insulin Lispro Injection prefilled pens must never be shared between patients, even if the needle is changed. Patients using Insulin Lispro Injection vials must never share needles or syringes with another person. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762 Dispense in the original sealed carton with the enclosed Instructions for Use. Do not use after the expiration date. Unopened Insulin Lispro Injection should be stored in a refrigerator (36° to 46°F [2° to 8°C]), but not in the freezer. Do not use Insulin Lispro Injection if it has been frozen. In-use Insulin Lispro Injection vials and Insulin Lispro Injection prefilled pens should be stored at room temperature, below 86°F (30°C) and must be used within 28 days or be discarded, even if they still contain Insulin Lispro Injection. Protect from direct heat and light. See table below: Use in an External Insulin Pump — Change the Insulin Lispro Injection in the reservoir at least every 7 days, change the infusion sets and the infusion set insertion site at least every 3 days or after exposure to temperatures that exceed 98.6°F (37°C). Diluted Insulin Lispro Injection for Subcutaneous Injection — Diluted Insulin Lispro Injection may remain in patient use for 28 days when stored at 41°F (5°C) and for 14 days when stored at 86°F (30°C). Do not dilute Insulin Lispro Injection used in an external insulin pump. Diluted Insulin Lispro Injection for Subcutaneous Injection — Insulin Lispro Injection may be diluted with Sterile Diluent for Insulin Lispro Injection for subcutaneous injection. Diluting one part Insulin Lispro Injection to nine parts diluent will yield a concentration one-tenth that of Insulin Lispro Injection (equivalent to U-10). Diluting one part Insulin Lispro Injection to one part diluent will yield a concentration one-half that of Insulin Lispro Injection (equivalent to U-50). Infusion bags prepared with Insulin Lispro Injection are stable when stored in a refrigerator (2° to 8°C [36° to 46°F]) for 48 hours and then may be used at room temperature for up to an additional 48 hours [see Dosage and Administration ( 2.2)] .

Autorisation status:

Biologic Licensing Application

Produktets egenskaber

INSULIN LISPRO- INSULIN LISPRO INJECTION, SOLUTION
REMEDYREPACK INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
INSULIN LISPRO SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR INSULIN LISPRO.
INSULIN LISPRO INJECTION, FOR SUBCUTANEOUS OR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1996
RECENT MAJOR CHANGES
Dosage and Administration ( 2.2)
11/2019
Warnings and Precautions ( 5.2)
11/2019
INDICATIONS AND USAGE
Insulin Lispro Injection is a rapid acting human insulin analog
indicated to improve glycemic control in
adults and children with diabetes mellitus. ( 1)
DOSAGE AND ADMINISTRATION
See Full Prescribing Information for important administration
instructions. ( 2.1, 2.2, 2.3, 2.4)
Subcutaneous injection ( 2.2):
Administer Insulin Lispro Injection by subcutaneous injection into the
abdominal wall, thigh, upper
arm, or buttocks within 15 minutes before a meal or immediately after
a meal.
Rotate injection sites to reduce risk of lipodystrophy and localized
cutaneous amyloidosis.
Continuous subcutaneous infusion (Insulin Pump) ( 2.2):
Administer Insulin Lispro Injection by continuous subcutaneous
infusion using an insulin pump in a
region recommended in the instructions from the pump manufacturer.
Rotate infusion sites to reduce risk of lipodystrophy and localized
cutaneous amyloidosis.
Intravenous Infusion ( 2.2):
Administer Insulin Lispro Injection by intravenous infusion ONLY after
dilution and under medical
supervision.
The dosage of Insulin Lispro Injection must be individualized based on
the route of administration and
the individual's metabolic needs, blood glucose monitoring results and
glycemic control goal. ( 2.3)
Do not perform dose conversion when using the Insulin Lispro Injection
prefilled pens. The dose window
shows the number of insulin units to be delivered and no conversion is
needed. ( 2.1, 2.3)
DOSAGE FORMS AND STRENGTHS
Injection: 100 units/mL (U-100) is available as: ( 3)
10 mL multiple-dose vial
3 mL single-patient-us