PLUSET

Minitube of America, Inc.

PLUSET Swine pituitary gonadotrophins

FULL PRESCRIBING INFORMATION: CONTENTS*

• PLUSET DESCRIPTION
• PROPERTIES AND ACTION
• ANIMAL SPECIES AND INDICATIONS
• CONTRA-INDICATIONS
• WARNINGS
• PLUSET DOSAGE AND ADMINISTRATION ROUTE
• STORAGE
• CONTENTS

FULL PRESCRIBING INFORMATION

PLUSET DESCRIPTION

PLUSET 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 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 must be intra-muscular (i.m.). Subcutaneous administration results in an irregular absorption and must be avoided.

Reconstitute each vial of PLUSET with 20 ml of the PLUSET diluent provided.
Reconstitution and subsequent withdrawal of product should be performed using strict aseptic technique.

Draw the complete contents of the diluent bottle into a 20 ml syringe.
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 1 vial, 700 IU FSH/700 IU LH. Includes 1 x 20 ml vial PLUSET diluent (sterile).