PLUSET FLEX H- porcine follicle stimulating hormone, porcine luteinizing hormone 
Minitube of America, Inc.

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.

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PLUSET FLEX H Swine pituitary gonadotrophins

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.

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

For the induction of superovulation in bovine females.

CONTRA-INDICATIONS

There are no ascertained contra-indications.

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

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


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.

CONTENTS

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

image box
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

Revised: 5/2013
Document Id: 0e7a55bf-89f1-4a10-891f-a76957d6ca28
Set id: 0bef5fbe-7aec-4ef5-986f-31c5a563d57d
Version: 5
Effective Time: 20130516
 
Minitube of America, Inc.