LANTUS SOLOSTAR- insulin glargine injection, solution

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

INSULIN GLARGINE (UNII: 2ZM8CX04RZ) (INSULIN GLARGINE - UNII:2ZM8CX04RZ)

Disponible depuis:

REMEDYREPACK INC.

Mode d'administration:

SUBCUTANEOUS

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

LANTUS is indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus. Limitations of Use LANTUS is not recommended for the treatment of diabetic ketoacidosis. LANTUS is contraindicated: - during episodes of hypoglycemia [see Warnings and Precautions (5.3)] - in patients with hypersensitivity to LANTUS or one of its excipients [see Warnings and Precautions (5.5)] Risk Summary Published studies with use of insulin glargine during pregnancy have not reported a clear association with insulin glargine and adverse developmental outcomes [see Data] . There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy [see Clinical Considerations] . Rats and rabbits were exposed to insulin glargine in animal reproduction studies d

Descriptif du produit:

LANTUS (insulin glargine injection) is supplied as a clear solution containing 100 units per mL (U-100) available in: SoloStar single-patient-use prefilled pen, total volume: 3 mL, concentration: 100 Units/mL, 5 pens per carton NDC: 70518-1390-00 PACKAGING: 5 in 1 PACKAGE, 3 mL in 1 SYRINGE, TYPE 2 The LANTUS SoloStar prefilled pen dials in 1-unit increments. Needles are not included in the packs. BD Ultra-Fine® needles1 to be used in conjunction with SoloStar prefilled pens are sold separately and are manufactured by BD. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Statut de autorisation:

Biologic Licensing Application

Résumé des caractéristiques du produit

LANTUS SOLOSTAR- INSULIN GLARGINE INJECTION, SOLUTION
REMEDYREPACK INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LANTUS SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR LANTUS.
LANTUS (INSULIN GLARGINE INJECTION) FOR SUBCUTANEOUS INJECTION
INITIAL U.S. APPROVAL: 2000
INDICATIONS AND USAGE
LANTUS is a long-acting human insulin analog indicated to improve
glycemic control in adults and pediatric
patients with type 1 diabetes mellitus and in adults with type 2
diabetes mellitus. ( 1)
Limitations of Use
Not recommended for treating diabetic ketoacidosis. ( 1)
DOSAGE AND ADMINISTRATION
Individualize dosage based on metabolic needs, blood glucose
monitoring, glycemic control, type of
diabetes, and prior insulin use. ( 2.1, 2.3, 2.4)
Administer subcutaneously into the abdominal area, thigh, or deltoid
once daily at any time of day, but
at the same time every day. ( 2.1)
Do not dilute or mix with any other insulin or solution. ( 2.1)
Rotate injection sites to reduce risk of lipodystrophy and localized
cutaneous amyloidosis. ( 2.2)
Closely monitor glucose when changing to LANTUS and during initial
weeks thereafter. ( 2.4)
DOSAGE FORMS AND STRENGTHS
Injection: 100 units/mL (U-100) available as:
10 mL multiple-dose vial ( 3)
3 mL single-patient-use SoloStar prefilled pen ( 3)
CONTRAINDICATIONS
During episodes of hypoglycemia ( 4)
Hypersensitivity to LANTUS or one of its excipients ( 4)
WARNINGS AND PRECAUTIONS
Never share a LANTUS SoloStar prefilled pen 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. Increase frequency of glucose
monitoring with changes to:
insulin dosage, coadministered glucose lowering medic