HUMULIN N- 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 N is an intermediate-acting recombinant human insulin indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus. HUMULIN N is contraindicated: - During episodes of hypoglycemia [see Warnings and Precautions (5.3)] , and - In patients who have had hypersensitivity reactions to HUMULIN N 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 decline a

產品總結:

Product: 50090-0352 NDC: 50090-0352-0 10 mL in a VIAL

授权状态:

New Drug Application

产品特点

HUMULIN N - 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 N SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR HUMULIN N.
HUMULIN N (HUMAN INSULIN [RDNA ORIGIN] ISOPHANE SUSPENSION),
INJECTABLE SUSPENSION, FOR SUBCUTANEOUS USE
INITIAL U.S. APPROVAL: 1982
RECENT MAJOR CHANGES
None .
INDICATIONS AND USAGE
HUMULIN N is an intermediate-acting human insulin indicated to improve
glycemic control in adult and pediatric 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, 2.4)
May use with a meal-time insulin if indicated. (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 N KwikPen
(prefilled). (3)
CONTRAINDICATIONS
During episodes of hypoglycemia. (4)
In patients with hypersensitivity to HUMULIN N or any of its
excipients. (4)
WARNINGS AND PRECAUTIONS
Never share a HUMULIN N 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 N, monitor and treat if indicated. (5.4)
_Hypokalemia_: May be life-threatening. Monitor