Label: LHRHA- leutenizing hormone-releasing hormone analogue injection, powder, for suspension

  • NDC Code(s): 50378-018-01, 50378-018-05, 50378-018-25
  • Packager: Western Chemical Inc.
  • Category: OTC ANIMAL DRUG LABEL

Drug Label Information

Updated July 6, 2023

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • WARNING:

    Care should be taken to avoid accidental contact or self-injection. In the event of accidental self-injection, seed medical advice immediatley. KEEP OUT OF THE REACH OF CHILDREN

    CAUTION:

    FOR USE IN BROODSTOCK ONLY

    NOT FOR USE IN HUMANS

    STORAGE:
    Store below 25°C and protect from sunlight. Solutions may be frozen and used at a later date.

  • DIRECTIONS FOR USE:

    LHRHa is packages as a powder ready to be diluted with sterile saline for injection.

    LHRHa is a broad species (low specificity) spawning enhancement peptide. The peptide is intended to provide the ability to synchronize spawns and reduce waiting times and spawn failures. Fish must be sexually mature.

    CLEANLINESS – Ensure that all equipment is clean, and if possible, sterilized. Always clean equipment with a disinfectant between applications.
    INJECTION – Hold the fish firmly and insert the needle into the belly behind the pelvic fin, in the muscle on either side of the dorsal fin or subcutaneously. Inject LHRHa carefully, and quickly remove the needle. Gently place the fish into a container or clean aerated water.
    SEDATION FOR HANDLING – If necessary sedate broodstock prior to injection.
    RECOVERY – After the fish has recovered from any sedation (5 to 10 minutes), return it to the breeding tank.

  • DOSE CALCULATION:

    The dose calculated based on the weight of the fish. A general dose of LHRHa is 10-20 μg per kilogram of bodyweight. This dose may vary among finfish species and locations. Males may require a reduced dose. Ensure that an adequate ratio of males to females is induced at the same time. For most species a single dose of LHRHa is required. For other species a split dose of one quarter (primer dose) and three quarters (resolving dose) may be required. Environmental and temperature play a significant role in the reproductive process and may affect does and timing.

    DILUTION:
    Using a sterile syringe and needle, add the appropriate volume of the sterile saline to the LHRHa vial. A volume of 0.1 to 0.5 ml of solution is appropriate for most species. Shake the vial to thoroughly dissolve the LHRHa.
    E.g., for 20 fish weighing 5 kg each, use 1 mg vial of LHRHa. Add 10 ml sterile saline to the LHRHa, shake the vial to ensure all of the LHRHa is dissolved. Inject 0.5 ml of solution in each fish.

  • LHRHa 1mg_EXPORT.jpg

    LHRHa 1mg_EXPORT.jpg

  • LHRHa 5 mg_Export.jpg

    LHRHa 5 mg_Export.jpg

  • LHRHa 25 mg_Export.jpg

    LHRHa 25 mg_Export.jpg

  • INGREDIENTS AND APPEARANCE
    LHRHA 
    leutenizing hormone-releasing hormone analogue injection, powder, for suspension
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:50378-018
    Route of AdministrationINTRAMUSCULAR
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALARELIN ACETATE (UNII: 288L2XKV2J) (ALARELIN - UNII:NJS328SUA7) ALARELIN ACETATE800 ug  in 1 mg
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50378-018-011 mg in 1 BOTTLE, GLASS
    2NDC:50378-018-2525 mg in 1 BOTTLE, GLASS
    3NDC:50378-018-055 mg in 1 BOTTLE, GLASS
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    export only07/06/2023
    Labeler - Western Chemical Inc. (085803500)
    Establishment
    NameAddressID/FEIBusiness Operations
    Western Chemical Inc.085803500label, relabel, pack, repack, manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    BCN Peptides SA468203687api manufacture