Drug Information for Lantus (Physicians Total Care, Inc.): 16 HOW SUPPLIED/STORAGE AND HANDLING

Ads
  • LANTUS solution for injection 100 units per mL (U-100) is available as:

    Dose Unit/StrengthPackage SizeNDC #
    54868
    10 mL vialsPack of 14626-0
    100 Units/mL
    3 mL cartridge system (*)package of 55765-0
    100 Units/mL
    (*) Cartridge systems are for use only in OptiClik® (Insulin Delivery Device)

    Needles are not included in the packs.

    BD Ultra-Fine™ needles1 to be used in conjunction with SoloStar and OptiClik are sold separately and are manufactured by BD.

    1The brands listed are the registered trademarks of their respective owners and are not trademarks of sanofi-aventis U.S. LLC 16.2 Storage

    LANTUS should not be stored in the freezer and should not be allowed to freeze. Discard LANTUS if it has been frozen.

    Unopened Vial/Cartridge system/SoloStar disposable insulin device:

    Unopened LANTUS vials, cartridge systems and SoloStar device should be stored in a refrigerator, 36°F – 46°F (2°C – 8°C). Discard after the expiration date.

    Open (In-Use) Vial:

    Vials must be discarded 28 days after being opened. If refrigeration is not possible, the open vial can be kept unrefrigerated for up to 28 days away from direct heat and light, as long as the temperature is not greater than 86°F (30°C).

    Open (In-Use) Cartridge system:

    The opened (in-use) cartridge system in OptiClik should NOT be refrigerated but should be kept at room temperature (below 86°F [30°C]) away from direct heat and light. The opened (in-use) cartridge system in OptiClik must be discarded 28 days after being opened. Do not store OptiClik , with or without cartridge system, in a refrigerator at any time.

    Open (In-Use) SoloStar disposable insulin device:

    The opened (in-use) SoloStar should NOT be refrigerated but should be kept at room temperature (below 86°F [30°C]) away from direct heat and light. The opened (in-use) SoloStar device must be discarded 28 days after being opened.

    These storage conditions are summarized in the following table:

    Not in-use (unopened)Not in-use (unopened)In-use(opened)
    RefrigeratedRoom Temperature
    (See Temperature Below)
    10 mL VialUntil expiration date28 days28 days
    Refrigerated or room temperature
    3 mL Cartridge systemUntil expiration date28 days28 days
    Refrigerated or room temperature
    3 mL Cartridge system inserted into OptiClik®28 daysRoom temperature only (Do not refrigerate)
    16.3 Preparation and handling

    Parenteral drug products should be inspected visually prior to administration whenever the solution and the container permit. LANTUS must only be used if the solution is clear and colorless with no particles visible.

    Mixing and diluting: LANTUS must NOT be diluted or mixed with any other insulin or solution [See Warnings and Precautions (5.2)].

    Vial: The syringes must not contain any other medicinal product or residue.

    Cartridge system/SoloStar: If OptiClik, the Insulin Delivery Device used with the LANTUS cartridge system, or SoloStar disposable insulin device, malfunctions, LANTUS may be drawn from the cartridge system or from SoloStar into a U-100 syringe and injected.

  • Drug Information Provided by National Library of Medicine (NLM).
Ads