HUMALOG- insulin lispro injection, solution

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

REMEDYREPACK INC.

Mode d'administration:

INTRAVENOUS

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

HUMALOG is a rapid acting human insulin analog indicated to improve glycemic control in adults and children with diabetes mellitus. HUMALOG is contraindicated: - during episodes of hypoglycemia - in patients who are hypersensitive to HUMALOG or to any of its excipients. Pregnancy Category B. All pregnancies have a background risk of birth defects, loss, or other adverse outcome regardless of drug exposure. This background risk is increased in pregnancies complicated by hyperglycemia and may be decreased with good metabolic control. It is essential for patients with diabetes or history of gestational diabetes to maintain good metabolic control before conception and throughout pregnancy. In patients with diabetes or gestational diabetes insulin requirements may decrease during the first trimester, generally increase during the second and third trimesters, and rapidly decline after delivery. Careful monitoring of glucose control is essential in these patients. Therefore, female patients should be advised to tell

Descriptif du produit:

HUMALOG is available as: Each prefilled KwikPen, cartridge, and reusable pen compatible with Lilly 3 mL cartridges is for use by a single patient. HUMALOG KwikPens, 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. Do not use after the expiration date. Unopened HUMALOG should be stored in a refrigerator (36° to 46°F [2° to 8°C]), but not in the freezer. Do not use HUMALOG if it has been frozen. In-use HUMALOG vials, cartridges, and HUMALOG KwikPen 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 HUMALOG. Protect from direct heat and light. See table below: Use in an External Insulin Pump — Change the HUMALOG U-100 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). A HUMALOG 3 mL cartridge used in the D-Tron pumps should be discarded after 7 days, even if it still contains HUMALOG. However, as with other external insulin pumps, the infusion set should be replaced and a new infusion set insertion site should be selected at least every 3 days. Diluted HUMALOG U-100 for Subcutaneous Injection — Diluted HUMALOG 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 HUMALOG contained in a cartridge or HUMALOG used in an external insulin pump. Diluted HUMALOG U-100 for Subcutaneous Injection — HUMALOG may be diluted with Sterile Diluent for HUMALOG for subcutaneous injection. Diluting one part HUMALOG to nine parts diluent will yield a concentration one-tenth that of HUMALOG (equivalent to U-10). Diluting one part HUMALOG to one part diluent will yield a concentration one-half that of HUMALOG (equivalent to U-50). Infusion bags prepared with HUMALOG U-100 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)] .

Statut de autorisation:

New Drug Application

Résumé des caractéristiques du produit

HUMALOG- 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
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 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: Administer HUMALOG
U-100 or U-200 by subcutaneous injection within 15 minutes before a
meal or immediately after a meal. ( 2.2)
Continuous subcutaneous infusion (Insulin Pump): Administer HUMALOG
U-100 by continuous subcutaneous infusion
using an insulin pump. DO NOT administer HUMALOG U-200 by continuous
subcutaneous infusion. ( 2.2)
Intravenous Infusion: Administer HUMALOG U-100 by intravenous infusion
ONLY after dilution and under medical
supervision. DO NOT administer HUMALOG U-200 by intravenous infusion.
( 2.2)
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 HUMALOG U-100 or U-200
KwikPens. The dose window shows the
number of insulin units to be delivered and no conversion is needed. (
2.1, 2.3)
Do not mix HUMALOG U-200 with any other insulin. ( 2.4)
DOSAGE FORMS AND STRENGTHS
HUMALOG 100 units/mL (U-100) is available as: ( 3)
10 mL vials
3 mL vials
3 mL Humalog KwikPen
(prefilled)
3 mL Humalog
Junior KwikPen
(prefilled)
3 mL cartridges
HUMALOG 200 units/mL (U-200) is available as: ( 3)
3 mL Humalog KwikPen
(prefilled)
CONTRAINDICATIONS
Do not use during episodes of hypoglycemia. ( 4)
Do not use in patients with hypersensitivity to HUMALOG or any of its
excipients. ( 4)
WARNIN