NOVOLOG MIX 70/30- insulin aspart injection, suspension

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

INSULIN ASPART (UNII: D933668QVX) (INSULIN ASPART - UNII:D933668QVX)

Saadav alates:

Physicians Total Care, Inc.

INN (Rahvusvaheline Nimetus):

INSULIN ASPART

Koostis:

INSULIN ASPART 100 [iU] in 1 mL

Manustamisviis:

SUBCUTANEOUS

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

NovoLog Mix 70/30 is an insulin analog indicated to improve glycemic control in patients with diabetes mellitus.   Important Limitations of Use:   In premix insulins, such as Novolog Mix 70/30, the proportions of rapid acting and long acting insulins are fixed and do not allow for basal versus prandial dose adjustments. NovoLog Mix 70/30 is contraindicated - during episodes of hypoglycemia - in patients with hypersensitivity to NovoLog  Mix 70/30 or one of its excipients. Enter section text here 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. Insulin requirements may decrease during the first trimester, generally increase during

Toote kokkuvõte:

Enter section text here NovoLog Mix 70/30 is available in the following package sizes: each presentation contains 100 Units of insulin aspart per mL (U-100). NovoLog Mix 70/30 vials and NovoLog Mix 70/30 FlexPen are latex free. Unused NovoLog Mix 70/30 should be stored in a refrigerator between 2°C and 8°C (36°F to 46°F). Do not store in the freezer or directly adjacent to the refrigerator cooling element. Do not freeze NovoLog Mix 70/30 or use NovoLog Mix 70/30 if it has been frozen . Vials: After initial use, a vial may be kept at temperatures below 30°C (86°F) for up to 28 days, but should not be exposed to excessive heat or sunlight. Open vials may be refrigerated. Unpunctured vials can be used until the expiration date printed on the label if they are stored in a refrigerator. Keep unused vials in the carton so they will stay clean and protected from light. NovoLog Mix 70/30 FlexPen: Once a NovoLog Mix 70/30 FlexPen is punctured, it should be kept at temperatures below 30°C (86°F) for up to 14 days, but should not be exposed to excessive heat or sunlight. A NovoLog Mix 70/30 FlexPen in use must NOT be stored in the refrigerator. Keep the disposable NovoLog Mix 70/30 FlexPen away from direct heat and sunlight. An unpunctured NovoLog Mix 70/30 FlexPen can be used until the expiration date printed on the label if they are stored in a refrigerator. Keep any unused NovoLog Mix 70/30 FlexPen in the carton so it will stay clean and protected from light. These storage conditions are summarized in the following table: Not in-use (unopened) Room Temperature Not in-use (unopened) Refrigerated In-use (opened) Room Temperature

Volitamisolek:

New Drug Application

Toote omadused

NOVOLOG MIX 70/30 - INSULIN ASPART INJECTION, SUSPENSION
PHYSICIANS TOTAL CARE, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
NOVOLOG MIX 70/30 SAFELY AND EFFECTIVELY.
SEE FULL PRESCRIBING INFORMATION FOR NOVOLOG MIX 70/30. NOVOLOG® MIX
70/30 (70% INSULIN ASPART PROTAMINE
SUSPENSION AND 30% INSULIN ASPART INJECTION, [RDNA ORIGIN]) SUSPENSION
FOR SUBCUTANEOUS INJECTION INITIAL U.S.
APPROVAL: 2001
RECENT MAJOR CHANGES
Indications and Usage (1) 5/2010
Dosage and Administration (2.1) 5/2010
INDICATIONS AND USAGE
NovoLog Mix 70/30 is an insulin analog indicated to improve glycemic
control in patients with diabetes mellitus.
Important Limitations of Use: In premix insulins, such as Novolog Mix
70/30, the proportions of rapid acting and long acting
insulins are fixed and do not allow for basal versus prandial dose
adjustments (1).
DOSAGE AND ADMINISTRATION
Only for subcutaneous injection (2.1)
Type 1 DM: dose within 15 minutes before meal initiation.
Type 2 DM: dose within 15 minutes before or after starting a meal.
Do not administer intravenously (2.1).
Do not use in insulin infusion pumps (2.1).
Must be resuspended immediately before use (2.2).
DOSAGE FORMS AND STRENGTHS
Each presentation contains 100 Units of insulin aspart per mL (U-100)
(3)
10 mL vials
3 mL NovoLog Mix 70/30 FlexPen
CONTRAINDICATIONS
Do not use during episodes of hypoglycemia (4).
Do not use in patients with hypersensitivity to NovoLog Mix 70/30 or
one of its excipients (4).
WARNINGS AND PRECAUTIONS
NovoLog Mix 70/30 should not be mixed with any other insulin product
(5.1).
Hypoglycemia is the most common adverse effect of insulin therapy.
Glucose monitoring is recommended for all
patients with diabetes. Any change of insulin dose should be made
cautiously and only under medical supervision
(5.1,5.2).
Insulin, particularly when given in settings of poor glycemic control,
can cause hypokalemia. Use caution in patients
predisposed to hypokalemia (5.3).
Like all insulins, NovoL