HUMALOG- insulin lispro injection, solution HUMALOG PEN- insulin lispro injection, solution HUMALOG CARTRIDGE- insulin lispro

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

Physicians Total Care, Inc.

INN (mednarodno ime):

Insulin lispro

Sestava:

Insulin lispro 100 [iU] in 1 mL

Pot uporabe:

SUBCUTANEOUS

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

HUMALOG is an 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 their physicians

Povzetek izdelek:

HUMALOG 100 units per mL (U-100) is available as: 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, pens, 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 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 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 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).

Status dovoljenje:

New Drug Application

Lastnosti izdelka

HUMALOG - INSULIN LISPRO INJECTION, SOLUTION
HUMALOG PEN- INSULIN LISPRO INJECTION, SOLUTION
HUMALOG CARTRIDGE- INSULIN LISPRO INJECTION, SOLUTION
PHYSICIANS TOTAL CARE, 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, USP [RDNA ORIGIN]) FOR INJECTION
INITIAL U.S. APPROVAL: 1996
RECENT MAJOR CHANGES
Dosage and Administration, Continuous Subcutaneous Infusion (Insulin
Pump) (2.3)
05/2011
Warnings and Precautions, Subcutaneous Insulin Infusion Pumps (5.7)
05/2011
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
The dosage of HUMALOG must be individualized. (2.1)
SUBCUTANEOUS INJECTION
Administer within 15 minutes before a meal or immediately after a
meal. Use in a
regimen with an intermediate- or long-acting insulin. (2.2)
CONTINUOUS SUBCUTANEOUS
INFUSION PUMP
Change the HUMALOG in the reservoir at least every 7 days, change the
infusion set,
and the infusion set insertion site at least every 3 days. HUMALOG
must not be
mixed or diluted when used in an external insulin infusion pump. (2.3)
DOSAGE FORMS AND STRENGTHS
HUMALOG 100 units/mL (U-100) is available as: (3)
10 mL vials
3 mL vials
3 mL prefilled pens
3 mL Humalog
KwikPen™ (prefilled)
3 mL cartridges
CONTRAINDICATIONS
Do not use during episodes of hypoglycemia. (4)
Do not use in patients with hypersensitivity to HUMALOG or any of its
excipients. (4)
WARNINGS AND PRECAUTIONS
Dose adjustment and monitoring: Closely monitor blood glucose in all
patients treated with insulin. Change insulin
regimens cautiously and only under medical supervision. (5.1)
Hypoglycemia: Most common adverse reaction of insulin therapy and may
be life-threatening. (5.2)
Allergic reactions: Severe, life-threatening, generalized allergy,
including anaphylaxis, can occur wit