Label: PLUSET- porcine follicle stimulating hormone, porcine luteinizing hormone kit kit

  • NDC Code(s): 76307-101-01, 76307-201-02, 76307-301-03
  • Packager: Laboratorios Calier S.A.
  • Category: PRESCRIPTION ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated January 8, 2024

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  • Indications:

    To induce superovulation in reproductively mature heifers or cows.

  • Contraindications:

    Do not use in case of hypersensitivity to the active substance or to any of the excipients.  Do not use in males and reproductively immature female cattle.

  • Adverse reactions:

    Slight reduction in milk yield.  Following the treatment a delayed return to heat is possible.  Ovarian cysts may be formed as a result of induction of superovulation.  If you notice any serious effects or other effects not mentioned in this package leaflet, please inform your veterinary surgeon.

  • Dosage for each species, route and method of administration:

    Dosage Route and Method of Administration

  • Withdrawal period:

    Cattle: meat and offal: zero days; milk: zero hours

  • Special storage precautions:

    Keep out of the sight and reach of children. Store below 25°C. Reconstituted solution: store and transport refrigerated (+2°C to +8°C) and do not freeze.  Keep the vial in the outer carton.  Do not use this veterinary medicinal product after the expiry date which is stated on the label and carton after EXP.  The expiry date refers to the last day of that month.  Shelf-life after reconstitution according to directions: 6 days.

  • Special Warnings and User Warnings:

    Special and User Warnings

  • Special precautions for the disposal of unused product or waste materials, if any:

    Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.

  • Other information:

    Carboard box with 2 glass vials of 10ml of lyophilised product and 1 glass vial of 21ml of diluent.  

    For animal treatment only.  To be supplied only on veterinary prescription.

  • Package Insert

    PLUSET Package Insert - Page 1PLUSET Package Insert - Page 2

  • PLUSET lyophilized powder vial label

    PLUSET Powder Vial Label

  • PLUSET Solvent vial label

    PLUSET Solvent Vial Label

  • PLUSET Carton Label

    PLUSET Carton Label

  • INGREDIENTS AND APPEARANCE
    PLUSET 
    porcine follicle stimulating hormone, porcine luteinizing hormone kit kit
    Product Information
    Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:76307-101
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76307-101-011 in 1 CARTON
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 12 VIAL, MULTI-DOSE 20 mL
    Part 21 VIAL, GLASS 21 mL
    Part 1 of 2
    PLUSET 
    follicle stimulating hormone, luteinizing hormone injection, powder, lyophilized, for solution
    Product Information
    Item Code (Source)NDC:76307-201
    Route of AdministrationINTRAMUSCULAR
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FOLLICLE STIMULATING HORMONE (PORCINE) (UNII: 8FYM5179QJ) (FOLLICLE STIMULATING HORMONE (PORCINE) - UNII:8FYM5179QJ) FOLLICLE STIMULATING HORMONE (PORCINE)50 [iU]  in 1 mL
    LUTEINIZING HORMONE (UNII: 8XA4VN1LH4) (LUTEINIZING HORMONE - UNII:8XA4VN1LH4) LUTEINIZING HORMONE50 [iU]  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76307-201-0210 mL in 1 VIAL, MULTI-DOSE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other01/10/2024
    Part 2 of 2
    PLUSET SOLVENT 
    physiological saline injection
    Product Information
    Item Code (Source)NDC:76307-301
    Route of AdministrationINTRAMUSCULAR
    Inactive Ingredients
    Ingredient NameStrength
    CHLOROCRESOL (UNII: 36W53O7109) 0.021 g  in 1 mL
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76307-301-0321 mL in 1 VIAL, GLASS
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other01/10/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other01/10/2024
    Labeler - Laboratorios Calier S.A. (460009038)
    Establishment
    NameAddressID/FEIBusiness Operations
    Laboratorios Calier S.A.460009038analysis, manufacture, api manufacture, pack, label
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