HUMULIN 70/30- insulin human injection, suspension

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

INSULIN HUMAN (UNII: 1Y17CTI5SR) (INSULIN HUMAN - UNII:1Y17CTI5SR)

可用日期:

A-S Medication Solutions

INN（国际名称）:

INSULIN HUMAN

组成:

INSULIN HUMAN 100 [iU] in 1 mL

给药途径:

SUBCUTANEOUS

处方类型:

OTC DRUG

疗效迹象:

HUMULIN 70/30 is a fixed ratio premix recombinant human insulin formulation indicated to improve glycemic control in adult patients with diabetes mellitus. HUMULIN 70/30 is contraindicated: - During episodes of hypoglycemia [see Warnings and Precautions (5.3)], and - In patients who have had hypersensitivity reactions to HUMULIN 70/30 or any of its excipients [see Warnings and Precautions (5.4)] . Pregnancy Category B Risk Summary 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 de

產品總結:

Product: 50090-0444 NDC: 50090-0444-0 10 mL in a VIAL

授权状态:

New Drug Application

产品特点

HUMULIN 70/30 - INSULIN HUMAN INJECTION, SUSPENSION
A-S MEDICATION SOLUTIONS
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
HUMULIN 70/30 SAFELY AND EFFECTIVELY. SEE
FULL PRESCRIBING INFORMATION FOR HUMULIN 70/30.
HUMULIN 70/30 (70% HUMAN INSULIN ISOPHANE SUSPENSION AND 30% HUMAN
INSULIN INJECTION [RDNA ORIGIN])
INJECTABLE SUSPENSION, FOR SUBCUTANEOUS USE
INITIAL U.S. APPROVAL: 1989
RECENT MAJOR CHANGES
None .
INDICATIONS AND USAGE
HUMULIN 70/30 is an insulin indicated to improve glycemic control in
adult patients with diabetes mellitus. (1)
DOSAGE AND ADMINISTRATION
Only administer subcutaneously (in abdominal wall, thigh, upper arm,
or buttocks). (2.2)
Individualize and adjust dosage based on metabolic needs, blood
glucose monitoring results and glycemic control goal.
(2.3)
See Full Prescribing Information for dosage adjustments due to drug
interactions and patients with renal and hepatic
impairment. (2.3)
Administer approximately 30-45 minutes before a meal. (2.4)
DOSAGE FORMS AND STRENGTHS
Injectable suspension 100 units per mL (U-100) available as 10 mL
vials, 3 mL vials, and 3 mL HUMULIN 70/30 KwikPen
(prefilled). (3)
CONTRAINDICATIONS
During episodes of hypoglycemia. (4)
In patients with hypersensitivity to HUMULIN 70/30 or any of its
excipients. (4)
WARNINGS AND PRECAUTIONS
Never share a HUMULIN 70/30 KwikPen or syringe between patients, even
if the needle is changed. (5.1)
_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 frequency with changes to
insulin dosage, use of glucose lowering medications, meal pattern,
physical activity; in patients with renal or hepatic
impairment; and in patients with hypoglycemia unawareness. (5.3, 7,
8.6, 8.7)
_Hypersensitivity Reactions_: May be life-threatening. Discontinue
HUMULIN 70/30, monitor and treat if indicated. (5.4)
_Hypokalemia_: