NOVOLIN R- human insulin injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

TYA Pharmaceuticals

INN (International Name):

INSULIN HUMAN

Composition:

INSULIN HUMAN 100 [iU] in 1 mL

Administration route:

SUBCUTANEOUS

Prescription type:

OTC DRUG

Therapeutic indications:

Novolin R is indicated to improve glycemic control in adults and children with diabetes mellitus. Novolin R is contraindicated: 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 glycemic control. It is essential for patients with diabetes or a history of gestational diabetes to maintain good glycemic control before conception and throughout pregnancy. 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 important during pregnancy in patients with diabetes. Therefore, women should be advised to tell their healthcare provider if they intend to become, or if they become, pregnant while taking Novolin R. No reproductive toxicity studies have been performed with Novolin R. It 

Product summary:

NDC:64725-1833-1 in a VIAL of 10 INJECTION, SOLUTIONS Novolin R is available in 10 mL vials (NDC 0169-1833-11 and ReliOn brand NDC 0169-1833-02). The concentration of Novolin R is 100 USP units of human insulin (rDNA origin)/mL. One vial is provided in each sale pack. ® Unopened Novolin R vials should be stored in the refrigerator (36° - 46°F [2° - 8°C]). If carried as a spare or if refrigeration is not possible, unopened Novolin R vials can be kept at room temperature provided they are kept as cool as possible (not above 77 F [25 C]). If kept at room temperature, Novolin R vials must be discarded after 42 days even if they are unopened. o o In addition, unopened Novolin R vials should be kept in their cartons so that they will stay clean and protected from light. They should not be exposed to heat or light. Do not freeze and do not use Novolin R if it has been frozen. An opened (In use) Novolin R vial can be kept at room temperature provided it is kept as cool as possible (not above 77 F [25 C]) and away from heat or light. Do not refrigerate after first use. o o Unopened and opened (In use) Novolin R vials must be discarded 42 days after they are first kept out of the refrigerator, even if they still contain Novolin R insulin. Table 9: Storage Conditions for Novolin R vials Unopened (Refrigerated) Unopened (Room Temperature up to 77 F [25 C] ) o o Opened (In use) (Room Temperature up to 77 F [25 C]) o o Until expiration date 42 days * 42 days * Infusion bags prepared as indicated under are stable at room temperature for 24 hours. A certain amount of insulin will be initially adsorbed to the material of the infusion bag. DOSAGE AND ADMINISTRATION ( ) 2.3 Always remove the needle after each injection. Always use a new disposable syringe and needle for each injection to prevent contamination. Never use insulin after the expiry date which is printed on the label and carton.

Authorization status:

New Drug Application

Summary of Product characteristics

NOVOLIN R- HUMAN INSULIN INJECTION, SOLUTION
TYA PHARMACEUTICALS
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
NOVOLIN R SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR NOVOLIN R. INITIAL U.S. APPROVAL: 1991
NOVOLIN R (REGULAR, HUMAN INSULIN [RDNA ORIGIN] USP) SOLUTION FOR
SUBCUTANEOUS OR INTRAVENOUS USE
RECENT MAJOR CHANGES
Warnings and Precautions ( ) 3/2013 5.9
INDICATIONS AND USAGE
Novolin R is a short-acting recombinant human insulin indicated to
improve glycemic control in adults and children with
diabetes mellitus ( ). 1
DOSAGE AND ADMINISTRATION
•
•
•
•
DOSAGE FORMS AND STRENGTHS
Novolin R, Regular, Human Insulin Injection (rDNA origin) USP, 100
units/mL (U-100), is supplied in 10 mL vials ( ). 3
CONTRAINDICATIONS
•
•
WARNINGS AND PRECAUTIONS
•
•
•
•
•
•
ADVERSE REACTIONS
_Adverse reactions observed with Novolin R include hypoglycemia,
allergic reactions, injection site reactions, lipodystrophy,_
_weight gain and edema ( ). 6_
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACTNOVO NORDISK INC. AT
1-800-727-6500OR FDA AT 1-800-
FDA-1088 ORwww.fda.gov/medwatch.
DRUG INTERACTIONS
•
•
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 10/2014
®
The dosage and timing of Novolin R must be individualized ( ). 2.1
Subcutaneous injection: Administer approximately 30 minutes prior to
the start of a meal ( ). 2.2
Intravenous use: Use at concentrations from 0.05 to 1.0 Unit/mL in
infusion systems using polypropylene infusion
bags. Novolin R is stable in 0.9% sodium chloride, 5% dextrose, or 10%
dextrose with 40 mmol/L potassium chloride
( ). 2.3
Use in pumps: Not recommended due to risk of precipitation ( ). 2.4
Do not use during episodes of hypoglycemia ( ). 4
Do not use in patients with hypersensitivity to Novolin R or one of
its excipients ( ). 4
Hypoglycemia: Most common adverse reaction of insulin therapy and may
be life-threatening. Closely monitor blood
glucose. Changes in insulin or dosage should be mad