ADMELOG- insulin lispro injection, solution

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

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

Sẵn có từ:

REMEDYREPACK INC.

Tuyến hành chính:

SUBCUTANEOUS

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

ADMELOG is indicated to improve glycemic control in adults and pediatric patients 3 years and older with type 1 diabetes mellitus and adults with type 2 diabetes mellitus. ADMELOG is contraindicated: - during episodes of hypoglycemia. - in patients who are hypersensitive to insulin lispro or to any of the excipients. Risk Summary The limited available data with ADMELOG in pregnant women are insufficient to inform a drug-associated risk of adverse developmental outcomes. Published studies with another insulin lispro product 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 another insulin lispro product i

Tóm tắt sản phẩm:

ADMELOG: Insulin Lispro Injection 100 units per mL (U-100) is available as: Each prefilled SoloStar pen is for use by a single patient. ADMELOG SoloStar pen must never be shared between patients, even if the needle is changed. Patients using ADMELOG vials must never share needles or syringes with another person. The ADMELOG SoloStar prefilled pen dials in 1-unit increments. Do not use after the expiration date. Not in-use (unopened) ADMELOG should be stored in a refrigerator (36°F-46°F [2°C-8°C]), but not in the freezer. Do not use ADMELOG if it has been frozen. In-use (opened) ADMELOG vials and ADMELOG SoloStar 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 ADMELOG. Protect from direct heat and light. See table below: Use in an External Insulin Pump Insulin in the reservoir should be discarded after 7 days. 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 ADMELOG for Subcutaneous Injection Diluted ADMELOG may remain in patient use for up to 24 hours when stored in a refrigerator (36°F-46°F [2°C-8°C]) or for up to 4 hours when stored at room temperature (86°F [30°C]). Do not dilute ADMELOG used in an external insulin pump. Diluted ADMELOG for Subcutaneous Injection ADMELOG may be diluted with sterile 0.9% sodium chloride for subcutaneous injection. Diluting one part ADMELOG to one part 0.9% sodium chloride will yield a concentration one-half that of ADMELOG (equivalent to U-50). Infusion bags prepared with ADMELOG are stable when stored in a refrigerator (36°F-46°F [2°C-8°C]) for 24 hours or may be used at room temperature for up to 4 hours [see Dosage and Administration (2.2)] .

Tình trạng ủy quyền:

New Drug Application

Đặc tính sản phẩm

ADMELOG- INSULIN LISPRO INJECTION, SOLUTION
REMEDYREPACK INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ADMELOG SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR ADMELOG
.
ADMELOG (INSULIN LISPRO INJECTION), FOR SUBCUTANEOUS OR INTRAVENOUS
USE
INITIAL U.S. APPROVAL: 1996
INDICATIONS AND USAGE
ADMELOG is a rapid-acting human insulin analog indicated to improve
glycemic control in adults and pediatric patients 3
years and older with type 1 diabetes mellitus and adults with type 2
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 ADMELOG by subcutaneous injection
within 15 minutes before a meal or
immediately after a meal. ( 2.2)
Continuous subcutaneous infusion (Insulin Pump): Administer ADMELOG by
continuous subcutaneous infusion using
an insulin pump. ( 2.2)
Intravenous Infusion: Administer ADMELOG by intravenous infusion ONLY
after dilution and under medical
supervision. ( 2.2)
The dosage of ADMELOG 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)
DOSAGE FORMS AND STRENGTHS
Injection: 100 units/mL (U-100) is available as: ( 3)
10 mL multiple-dose vials
3 mL multiple-dose vials
3 mL single patient use SoloStar
prefilled pens
CONTRAINDICATIONS
Do not use during episodes of hypoglycemia. ( 4)
Do not use in patients with hypersensitivity to insulin lispro or any
of the excipients. ( 4)
WARNINGS AND PRECAUTIONS
_Never share_ an ADMELOG SoloStar disposable prefilled pen or syringe
between patients, even if the needle is changed.
( 5.1)
_Hyperglycemia or Hypoglycemia with Changes in Insulin Regimen: _Carry
out under close medical supervision and
increase frequency of blood glucose monitoring. ( 5.2)
_Hypoglycemia: _May be life-threatening. Monitor blood glucose and
increase monitoring frequen