PLUSET FLEX H

Manufacturer
Minitube of America, Inc. | Laboratorios Calier S.A. | KERN PHARMA S.L.
Effective date
2013-05-16
Label type
PRESCRIPTION ANIMAL DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 02:39:35

Label at a glance#

ProductPLUSET FLEX H
Active ingredientFollitropin, Lutropin alfa
Label structure9 sections

Dosage and administration

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 conten...

Storage and handling

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.

Label contents#

Full prescribing information#

DESCRIPTION

DESCRIPTION SECTION

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

MECHANISM OF ACTION SECTION

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

VETERINARY INDICATIONS SECTION

For the induction of superovulation in bovine females.

CONTRA-INDICATIONS

CONTRAINDICATIONS SECTION

There are no ascertained contra-indications.

WARNINGS

WARNINGS AND PRECAUTIONS SECTION

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

DOSAGE & ADMINISTRATION SECTION

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

STORAGE AND HANDLING SECTION

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

HOW SUPPLIED SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1116467follicle stimulating hormone 52.5 UNT/ML / luteinizing hormone 17.5 UNT/ML Injectable Solution [Pluset]SBD5
1116459follicle stimulating hormone 52.5 UNT/ML / luteinizing hormone 17.5 UNT/ML Injectable SolutionSCD5
1116467Pluset Flex H (Follicle Stimulating Hormone 525 UNT / Luteinizing Hormone 175 UNT) per 10 ML Injectable SolutionSY5

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
FOLLITROPIN Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813
LUTROPIN ALFA Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
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e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
19306eca-07d9-869e-c7a4-1581f31ccc9aProduct name220200323
568cb8c1-4b4c-2263-a98f-4f62151e332fProduct name220200323
79651c92-221b-ba7b-52e2-f902ea49889dProduct name220200323
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
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810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
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ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54129-307-33PLUSET FLEX H1 in 1 CARTONKIT15
54129-308-31PLUSET FLEX H10 mL in 1 VIAL, GLASSINJECTION, POWDER, LYOPHILIZED,20 mL52.5 [iU] in 1mL5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54129-200PLUSET FLEX H (PORCINE FOLLICLE STIMULATING HORMONE, PORCINE LUTEINIZING HORMONE) KIT [MINITUBE OF AMERICA, INC.]5Unmatched20130516_0bef5fbe-7aec-4ef5-986f-31c5a563d57d.zip
54129-307PLUSET FLEX H (PORCINE FOLLICLE STIMULATING HORMONE, PORCINE LUTEINIZING HORMONE) KIT [MINITUBE OF AMERICA, INC.]52 package rows20130516_0bef5fbe-7aec-4ef5-986f-31c5a563d57d.zip
54129-308PLUSET FLEX H (PORCINE FOLLICLE STIMULATING HORMONE, PORCINE LUTEINIZING HORMONE) KIT [MINITUBE OF AMERICA, INC.]5Unmatched20130516_0bef5fbe-7aec-4ef5-986f-31c5a563d57d.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
FollitropinACTIVE INGREDIENT076WHW89TW5
Lutropin alfaACTIVE INGREDIENT3JGY52XJNA5
FollitropinACTIVE MOIETY076WHW89TW5
Lutropin alfaACTIVE MOIETY3JGY52XJNA5

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54129-30754129-307-33
54129-30854129-308-31
54129-20054129-200-34

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Follistim AQFOLLITROPINOrganon LLC48489027-e52b-4b10-ae74-4ba03839150c2026-05-26Warnings, Adverse reactionsName fallback
generic name: FOLLITROPIN
Gonal-f RFF Redi-jectFOLLITROPINEMD Serono, Inc.b6d11c45-b502-478e-bb28-2ff596ea259c2025-04-03Warnings, Adverse reactionsName fallback
generic name: FOLLITROPIN

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.