PLUSET

Manufacturer
Laboratorios Calier S.A.
Effective date
2024-01-08
Label type
PRESCRIPTION ANIMAL DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:42:45

Label at a glance#

ProductPLUSET
Active ingredientFOLLICLE STIMULATING HORMONE (PORCINE), LUTEINIZING HORMONE
Label structure13 sections

Storage and handling

Keep out of the sight and reach of children. Store below 25°C. Reconstituted solution: store and transport refrigerated (+2°C to +8°C) and do not freeze.  Keep the vial in the outer carton.  Do not use this veterinary medicinal product after the expiry date which is stated on the label and carton after EXP.  The expiry date refers to the last day of that month.  Shelf-life after reconstitution according to directi...

Label contents#

Full prescribing information#

Indications:

VETERINARY INDICATIONS SECTION

To induce superovulation in reproductively mature heifers or cows.

Contraindications:

CONTRAINDICATIONS SECTION

Do not use in case of hypersensitivity to the active substance or to any of the excipients.  Do not use in males and reproductively immature female cattle.

Adverse reactions:

ADVERSE REACTIONS SECTION

Slight reduction in milk yield.  Following the treatment a delayed return to heat is possible.  Ovarian cysts may be formed as a result of induction of superovulation.  If you notice any serious effects or other effects not mentioned in this package leaflet, please inform your veterinary surgeon.

Dosage for each species, route and method of administration:

DOSAGE & ADMINISTRATION SECTION

Dosage Route and Method of AdministrationDosage Route and Method of Administration

Withdrawal period:

SPL UNCLASSIFIED SECTION

Cattle: meat and offal: zero days; milk: zero hours

Special storage precautions:

STORAGE AND HANDLING SECTION

Keep out of the sight and reach of children. Store below 25°C. Reconstituted solution: store and transport refrigerated (+2°C to +8°C) and do not freeze.  Keep the vial in the outer carton.  Do not use this veterinary medicinal product after the expiry date which is stated on the label and carton after EXP.  The expiry date refers to the last day of that month.  Shelf-life after reconstitution according to directions: 6 days.

Special Warnings and User Warnings:

WARNINGS SECTION

Special and User WarningsSpecial and User Warnings

Special precautions for the disposal of unused product or waste materials, if any:

PRECAUTIONS SECTION

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.

Other information:

SPL UNCLASSIFIED SECTION

Carboard box with 2 glass vials of 10ml of lyophilised product and 1 glass vial of 21ml of diluent.  

For animal treatment only.  To be supplied only on veterinary prescription.

Package Insert

SPL UNCLASSIFIED SECTION

PLUSET Package Insert - Page 1PLUSET Package Insert - Page 1PLUSET Package Insert - Page 2PLUSET Package Insert - Page 2

PLUSET lyophilized powder vial label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PLUSET Powder Vial LabelPLUSET Powder Vial Label

PLUSET Solvent vial label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PLUSET Solvent Vial LabelPLUSET Solvent Vial Label

PLUSET Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PLUSET Carton LabelPLUSET Carton Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76307-101-01PLUSET1 in 1 CARTONKIT11
76307-201-02PLUSET10 mL in 1 VIAL, MULTI-DOSEINJECTION, POWDER, LYOPHILIZED,20 mL50 [iU] in 1mL1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76307-101PLUSET (PORCINE FOLLICLE STIMULATING HORMONE, PORCINE LUTEINIZING HORMONE KIT) KIT [LABORATORIOS CALIER S.A.]12 package rows20240111_d1bdf4d1-db48-41f5-9efe-51d50b1f06b0.zip
76307-201PLUSET (PORCINE FOLLICLE STIMULATING HORMONE, PORCINE LUTEINIZING HORMONE KIT) KIT [LABORATORIOS CALIER S.A.]1Unmatched20240111_d1bdf4d1-db48-41f5-9efe-51d50b1f06b0.zip
76307-301PLUSET (PORCINE FOLLICLE STIMULATING HORMONE, PORCINE LUTEINIZING HORMONE KIT) KIT [LABORATORIOS CALIER S.A.]1Unmatched20240111_d1bdf4d1-db48-41f5-9efe-51d50b1f06b0.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76307-10176307-101-01
76307-20176307-201-02
76307-30176307-301-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Source Document#

Source XML

Reported adverse events (FAERS/openFDA)#

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