Label: PLUSET FLEX H- porcine follicle stimulating hormone, porcine luteinizing hormone

  • NDC Code(s): 54129-200-34, 54129-307-33, 54129-308-31
  • Packager: Minitube of America, Inc.
  • Category: PRESCRIPTION ANIMAL DRUG LABEL

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated May 16, 2013

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  • DESCRIPTION

    PLUSET FLEX H is a mixture of swine pituitary gonadotrophins used for the induction of multiple ovulations (superovulation). The use of standardized concentrations for both gonadotrophins guarantees a consistent quality of the product and eliminates possible variability in effectiveness from one lot to another. In the absence of an International Standard for the porcine gonadotrophin, dosing is carried out using the International Standard for human urine FSH and LH.

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  • PROPERTIES AND ACTION

    Ovarian stimulation with exogenous Follicle-Stimulating Hormone (FSH) allows a greater number of ova to be produced than normally produced in a single reproductive cycle.

    The pituitary hormone extract contains variable levels of Follicle-Stimulating Hormone (FSH) and Luteinizing Hormone (LH).

    Clearly in order to obtain proper and effective superovulation which provides satisfactory results involving a high number of living embryos, it is necessary to carry out a treatment that guarantees the activation and progress of multiple follicle maturation in the most "physiological" and repeatable way possible.

    Thus, given that it influences the activity of FSH, it is important to have a defined level of LH present.

    PLUSET FLEX H is manufactured in a method chosen to ensure that the defined level of LH content is consistently mantained.

    Kinetic studies of FSH and LH in the bloodstream of bovine has shown a half-life of 150  minutes for FSH and a half-life of 40 minutes for LH.

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  • ANIMAL SPECIES AND INDICATIONS

    For the induction of superovulation in bovine females.

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  • CONTRA-INDICATIONS

    There are no ascertained contra-indications.

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  • WARNINGS

    Do not slaughter animals for human consumption for 10 days following the last injection.
    Broken or cracked vials should be handled with gloves.

    KEEP OUT OF THE REACH OF CHILDREN

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  • DOSAGE AND ADMINISTRATION ROUTE

    The injection of PLUSET FLEX H must be intra-muscular (i.m.). Subcutaneous administration results in an irregular absorption and must be avoided.

    Reconstitute each vial of PLUSET FLEX H with 10 ml of the PLUSET diluent provided.
    Reconstitution and subsequent withdrawal of product should be performed using strict aseptic technique.

    Dispense the diluent into the lyophilizate bottle to completely resuspend the contents. Label the diluent bottle appropriately and mix thoroughly before use.

    Regimen 1: Mature cow

    Day                                                            AM                                                            PM

      1                                                               4 ml                                                            4 ml
      2                                                               3 ml                                                            3 ml  
      3                                                               2 ml                                                            1.5 ml
      4                                                               1.5 ml                                                         1 ml

    Regimen 2: Heifers

    Day                                                            AM                                                            PM

      1                                                               3 ml                                                            3 ml
      2                                                               2 ml                                                            2 ml  
      3                                                               1.5 ml                                                         1.5 ml
      4                                                               1 ml                                                            1 ml


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  • STORAGE

    The lyophilised product is stable for 24 months stored at temperature below 25 ºC. Once the preparation is prepared, the activity of the FSH and LH remain unchanged for at least six days, on condition that the preparation is stored at a temperature between 2 - 8 ºC and the normal precautions for maintaining sterility are followed.

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  • CONTENTS

    Each box contains 2 vials with 525 IU FSH/175 IU LH per vial. Includes 1 x 20 ml diluent (sterile) vial.

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  • INGREDIENTS AND APPEARANCE
    PLUSET FLEX H 
    porcine follicle stimulating hormone, porcine luteinizing hormone kit
    Product Information
    Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:54129-307
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:54129-307-33 1 in 1 CARTON
    Quantity of Parts
    Part # Package Quantity Total Product Quantity
    Part 1 2 VIAL, GLASS 20 mL
    Part 2 1 VIAL, GLASS 20 mL
    Part 1 of 2
    PLUSET FLEX H 
    follicle stimulating hormone, luteinizing hormone injection, powder, lyophilized, for solution
    Product Information
    Item Code (Source) NDC:54129-308
    Route of Administration INTRAMUSCULAR
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Follitropin (UNII: 076WHW89TW) (Follitropin - UNII:076WHW89TW) Follitropin 52.5 [iU]  in 1 mL
    Lutropin alfa (UNII: 3JGY52XJNA) (Lutropin alfa - UNII:3JGY52XJNA) Lutropin alfa 17.5 [iU]  in 1 mL
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:54129-308-31 10 mL in 1 VIAL, GLASS
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 09/01/2010
    Part 2 of 2
    PLUSET  DILUENT
    physiological saline injection
    Product Information
    Item Code (Source) NDC:54129-200
    Route of Administration INTRAMUSCULAR
    Inactive Ingredients
    Ingredient Name Strength
    Sodium Chloride (UNII: 451W47IQ8X)  
    Water (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:54129-200-34 20 mL in 1 VIAL, GLASS
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 03/01/2005
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 09/01/2010
    Labeler - Minitube of America, Inc. (555636117)
    Establishment
    Name Address ID/FEI Business Operations
    Laboratorios Calier S.A. 460009038 api manufacture, analysis, label, pack
    Establishment
    Name Address ID/FEI Business Operations
    KERN PHARMA S.L. 467325122 manufacture
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