HUMALOG- insulin lispro injection, solution HUMALOG KWIKPEN- insulin lispro injection, solution HUMALOG JUNIOR KWIKPEN- insuli

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

INN (Tarptautinis Pavadinimas):

Insulin lispro

Sudėtis:

Insulin lispro 100 [iU] in 1 mL

Vartojimo būdas:

INTRAVENOUS

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

HUMALOG is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. HUMALOG 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 HUMALOG [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 insulin lispro/kg/day.

Produkto santrauka:

HUMALOG (insulin lispro) injection is a clear and colorless solution available as: a Tempo Pen contains a component that allows for data connectivity when used with a compatible transmitter. The U-100 KwikPen, U-100 Tempo Pen, and U-200 KwikPen dial in 1-unit increments. The U-100 Junior KwikPen dials in 0.5-unit increments. Each prefilled pen, cartridge, and reusable pen compatible with Lilly 3 mL cartridges is for single-patient-use only. HUMALOG prefilled pens, cartridges, and reusable pens compatible with Lilly 3 mL cartridges must never be shared between patients, even if the needle is changed. Patients using HUMALOG 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, HUMALOG U-100 and U-200 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 HUMALOG U-100 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 HUMALOG U-100 for Subcutaneous Injection — Diluted HUMALOG for subcutaneous injection may be stored for 28 days when refrigerated at 41°F (5°C) and for 14 days at room temperature up to 86°F (30°C) [see Dosage and Administration (2.2 )]. Do not dilute HUMALOG contained in a cartridge or HUMALOG used in an external insulin pump. Storage of Intravenous Infusion Preparations with HUMALOG U-100 Intravenous infusion bags prepared with HUMALOG U-100 may be stored for 48 hours when refrigerated at 36° to 46°F (2° to 8°C). The prepared intravenous infusions 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

HUMALOG- INSULIN LISPRO INJECTION, SOLUTION
HUMALOG KWIKPEN - INSULIN LISPRO INJECTION, SOLUTION
HUMALOG JUNIOR KWIKPEN - INSULIN LISPRO INJECTION, SOLUTION
HUMALOG TEMPO PEN - INSULIN LISPRO INJECTION, SOLUTION
ELI LILLY AND COMPANY
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
HUMALOG SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR HUMALOG.
HUMALOG (INSULIN LISPRO) INJECTION, FOR SUBCUTANEOUS OR INTRAVENOUS
USE
INITIAL U.S. APPROVAL: 1996
INDICATIONS AND USAGE
HUMALOG 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 HUMALOG U-100 or U-200 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 HUMALOG U-100 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.
DO NOT administer HUMALOG U-200 by continuous subcutaneous infusion.
Intravenous Infusion (2.2):
Administer HUMALOG U-100 by intravenous infusion ONLY after dilution
and under medical
supervision. DO NOT administer HUMALOG U-200 by intravenous infusion.
The dosage of HUMALOG 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 HUMALO