INSULIN LISPRO injection, solution INSULIN LISPRO KWIKPEN- insulin lispro injection, solution INSULIN LISPRO JUNIOR KWIKPEN- i

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

Insulin lispro (UNII: GFX7QIS1II) (Insulin lispro - UNII:GFX7QIS1II)

Prieinama:

Eli Lilly and Company

Vartojimo būdas:

INTRAVENOUS

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

Insulin Lispro is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. Insulin Lispro is contraindicated: - during episodes of hypoglycemia [see Warnings and Precautions (5.3)] . - in patients who are hypersensitive to Insulin Lispro or to any of the excipients in Insulin Lispro [see Warnings and Precautions (5.5)] . Risk Summary 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 viability or morphology were observed in offspring of rats exposed to insulin lispro at a dose approximately 3 times the human subcutaneous dose of 1 unit i

Produkto santrauka:

Insulin Lispro injection is a clear and colorless solution available as: The KwikPen dials in 1-unit increments. The Junior KwikPen dials in 0.5-unit increments. Each Insulin Lispro prefilled pen is for single-patient-use only. Insulin Lispro prefilled pens must never be shared between patients, even if the needle is changed. Patients using Insulin Lispro vials must never share needles or syringes with another person. Dispense in the original sealed carton with the enclosed Instructions for Use. Protect from direct heat and light. Do not freeze and do not use if it has been frozen. See table below for storage information: * When stored at room temperature, Insulin Lispro can only be used for a total of 28 days, including both not in-use (unopened) and in-use (opened) storage time. Use in an External Insulin Pump — Change the Insulin Lispro in the reservoir at least every 7 days, or according to the pump user manual, whichever is shorter, or after exposure to temperatures that exceed 98.6°F (37°C). Storage of Diluted Insulin Lispro for Subcutaneous Injection — Diluted Insulin Lispro for subcutaneous injection may be stored for 28 days when refrigerated at 41°F (5°C) and 14 days at room temperature up to 86°F (30°C) [see Dosage and Administration (2.2)] . Do not dilute Insulin Lispro used in an external insulin pump. Storage of Intravenous Infusion Preparations with Insulin Lispro Intravenous infusion bags prepared with Insulin Lispro maybe stored for 48 hours when refrigerated at 36° to 46°F (2° to 8°C). The prepared intravenous bags may then be used at room temperature for up to an additional 48 hours [see Dosage and Administration (2.2)] .

Autorizacija statusas:

Biologic Licensing Application

Prekės savybės

INSULIN LISPRO- INSULIN LISPRO INJECTION, SOLUTION
INSULIN LISPRO KWIKPEN - INSULIN LISPRO INJECTION, SOLUTION
INSULIN LISPRO JUNIOR KWIKPEN - INSULIN LISPRO INJECTION, SOLUTION
ELI LILLY AND COMPANY
----------
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
THIS PRODUCT IS HUMALOG® (INSULIN LISPRO).
INDICATIONS AND USAGE
Insulin Lispro is a rapid acting human insulin analog indicated to
improve glycemic control in adult and
pediatric patients 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 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):
Refer to the insulin infusion pump user manual to see if Humalog can
be used. Use in accordance
with the insulin pump instructions for use.
Administer Insulin Lispro 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 by intravenous infusion ONLY after dilution
and under medical supervision.
The dosage of Insulin Lispro 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 prefilled
pens. The dose window shows
the number of insulin units to be delivered and no conver