Label: PLUSET FLEX H- porcine follicle stimulating hormone, porcine luteinizing hormone kit
- 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.
Updated May 16, 2013
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
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.
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.
- ANIMAL SPECIES AND INDICATIONS
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
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.
- PRINCIPAL DISPLAY PANEL
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