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

LHRHa by

Drug Labeling and Warnings

LHRHa by is a Animal medication manufactured, distributed, or labeled by Western Chemical Inc., BCN Peptides SA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 5 mg_Export.jpg

LHRHa 25 mg_Export.jpg

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 50378-018
Route of Administration	INTRAMUSCULAR

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALARELIN ACETATE (UNII: 288L2XKV2J) (ALARELIN - UNII:NJS328SUA7)	ALARELIN ACETATE	800 ug  in 1 mg

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50378-018-01	1 mg in 1 BOTTLE, GLASS
2	NDC: 50378-018-25	25 mg in 1 BOTTLE, GLASS
3	NDC: 50378-018-05	5 mg in 1 BOTTLE, GLASS

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
export only		07/06/2023

Labeler - Western Chemical Inc. (085803500)

Establishment
Name	Address	ID/FEI	Business Operations
Western Chemical Inc.		085803500	label, relabel, pack, repack, manufacture

Establishment
Name	Address	ID/FEI	Business Operations
BCN Peptides SA		468203687	api manufacture