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Rx Item-ADMELOG insulin lispro SUBCUT VIAL 100MG VL 3 ML BY SANOFI

RX836544Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop

Rx Item-ADMELOG insulin lispro SUBCUT VIAL 100MG VL 3 ML BY SANOFI

$47.08$44.99

RX86544 NDC No. ADMELOG insulin lispro SUBCUT VIAL 100MG VL 3 ML BY SANOFI 00024-5926-05 0024-5926-05 0024592605 00024592605 UPC/GTIN No.3-00245-92605-0 300245926050 300245-926050 MPN No.592605 Only Lic.-Physician, Pharmacy, Dentist, Drug Mfg, Dist., Gov, Hospital, Lic.Lab, Naturalist, Naturopath, NP, Optometrist, & Pharmacist, PA, Physical Therapist, Podiatrist, Research Co., Uni., VA, Vet & Wholesalers In Scope Of their Practice Can Order Rx Item.

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ADMELOG: Insulin Lispro Injection 100 units per mL (U-100) is available as:
Dosage Unit Package Size NDC #
10 mL multiple-dose vials Carton of 1 0024-5924-10
3 mL multiple-dose vials Carton of 1 0024-5926-05
3 mL single patient use SoloStar prefilled pen Carton of 5 0024-5925-05

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.

16.2 Storage and Handling

Dispense in the original sealed carton with the enclosed Instructions for Use.

Do not use after the expiration date.

Not in-use (unopened) ADMELOG should be stored in a refrigerator (36F-46F [2C-8C]), 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 86F [30C]) 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:
ADMELOG Not In-Use (Unopened)
Room Temperature (Below 86F [30C]) Not In-Use (Unopened)
Refrigerated (36F-46F [2C-8C]) In-Use (Opened)
Room Temperature (Below 86F [30C])
10 mL multiple-dose vial 28 days Until expiration date 28 days
refrigerated/room temperature
3 mL multiple-dose vial 28 days Until expiration date 28 days
refrigerated/room temperature
3 mL single-patient-use SoloStar prefilled pen 28 days Until expiration date 28 days
Do not refrigerate.

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 (36F-46F [2C-8C]) or for up to 4 hours when stored at room temperature (86F [30C]). Do not dilute ADMELOG used in an external insulin pump.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
RECENT MAJOR CHANGES
Dosage and Administration (2.2) 11/2019
Warnings and Precautions (5.2) 11/2019
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)
Rotate injection sites to reduce risk of lipodystrophy and localized cutaneous amyloidosis. (2.2)
Subcutaneous injection (2.2):
Administer ADMELOG by subcutaneous injection in the abdominal wall, thigh, upper arm, or buttocks within 15 minutes before a meal or immediately after a meal.
Rotate injection sites to reduce risk of lipodystrophy and localized cutaneous amyloidosis.
Continuous subcutaneous infusion (Insulin Pump) (2.2):
Administer ADMELOG by continuous subcutaneous infusion using an insulin pump in a region recommended in the instructions from the pump manufacturer.
Rotate infusion sites to reduce risk of lipodystrophy and localized cutaneous amyloidosis.
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: Make changes to a patient's insulin regimen (e.g., insulin strength, manufacturer, type, injection site or method of administration) under close medical supervision with increased 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, 6, 7, 8.6, 8.7)
Hypoglycemia Due to Medication Errors: Accidental mix-ups between insulin products can occur. Instruct patients to check insulin labels before injection. (5.4)
Hypersensitivity Reactions: Severe, life-threatening, generalized allergic, including anaphylaxis can occur. Discontinue ADMELOG, monitor and treat if indicated. (5.5)
Hypokalemia: May be life-threatening. Monitor potassium levels in patients at risk of hypokalemia and treat if indicated. (5.6)
Fluid Retention and Heart Failure with Concomitant Use of Thiazolidinediones (TZDs): Observe for signs and symptoms of heart failure; consider dosage reduction or discontinuation if heart failure occurs. (5.7)
Hyperglycemia and Ketoacidosis Due to Insulin Pump Device Malfunction: Monitor glucose and administer ADMELOG by subcutaneous injection if pump malfunction occurs. (5.8)

ADVERSE REACTIONS

Adverse reactions associated with ADMELOG include hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, pruritus, and rash. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact sanofi-aventis at 1-800-633-1610 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS

Drugs that Affect Glucose Metabolism: Adjustment of insulin dosage may be needed. (7.1, 7.2, 7.3)
Antiadrenergic Drugs (e.g., beta-blockers, clonidine, guanethidine, and reserpine): Signs and symptoms of hypoglycemia may be reduced or absent. (5.3, 7.4)

USE IN SPECIFIC POPULATIONS

Pediatrics: Safety and effectiveness not established in pediatric patients <3 years of age with type 1 diabetes mellitus or in pediatric patients with type 2 diabetes mellitus. (8.4)

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

Revised: 11/2019

RX836544
Rx Item-ADMELOG insulin lispro SUBCUT VI
RX836544

Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.
Rx Item-ADMELOG insulin lispro SUBCUT VI
Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.

Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop
AmericanPharmaWholesale.com
Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop