PLUSET FLEX H- porcine follicle stimulating hormone, porcine luteinizing hormone kit

PLUSET FLEX H by

Drug Labeling and Warnings

PLUSET FLEX H by is a Animal medication manufactured, distributed, or labeled by Minitube of America, Inc., Laboratorios Calier S.A., KERN PHARMA S.L.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

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