PLUSET- porcine follicle stimulating hormone, porcine luteinizing hormone kit 
Laboratorios Calier S.A.

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

Indications:

To induce superovulation in reproductively mature heifers or cows.

Contraindications:

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:

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 Route and Method of Administration

Withdrawal period:

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

Special storage precautions:

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:

Special and User Warnings

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

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:

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

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

PLUSET lyophilized powder vial label

PLUSET Powder Vial Label

PLUSET Solvent vial label

PLUSET Solvent Vial Label

PLUSET Carton Label

PLUSET Carton Label

PLUSET 
porcine follicle stimulating hormone, porcine luteinizing hormone kit kit
Product Information
Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:76307-101
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76307-101-011 in 1 CARTON
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 12 VIAL, MULTI-DOSE 20 mL
Part 21 VIAL, GLASS 21 mL
Part 1 of 2
PLUSET 
follicle stimulating hormone, luteinizing hormone injection, powder, lyophilized, for solution
Product Information
Item Code (Source)NDC:76307-201
Route of AdministrationINTRAMUSCULAR
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FOLLICLE STIMULATING HORMONE (PORCINE) (UNII: 8FYM5179QJ) (FOLLICLE STIMULATING HORMONE (PORCINE) - UNII:8FYM5179QJ) FOLLICLE STIMULATING HORMONE (PORCINE)50 [iU]  in 1 mL
LUTEINIZING HORMONE (UNII: 8XA4VN1LH4) (LUTEINIZING HORMONE - UNII:8XA4VN1LH4) LUTEINIZING HORMONE50 [iU]  in 1 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76307-201-0210 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other01/10/2024
Part 2 of 2
PLUSET SOLVENT 
physiological saline injection
Product Information
Item Code (Source)NDC:76307-301
Route of AdministrationINTRAMUSCULAR
Inactive Ingredients
Ingredient NameStrength
CHLOROCRESOL (UNII: 36W53O7109) 0.021 g  in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76307-301-0321 mL in 1 VIAL, GLASS
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other01/10/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other01/10/2024
Labeler - Laboratorios Calier S.A. (460009038)
Establishment
NameAddressID/FEIBusiness Operations
Laboratorios Calier S.A.460009038analysis, manufacture, api manufacture, pack, label

Revised: 1/2024
Document Id: e91054db-e77b-4f0d-86d9-561bca046ce4
Set id: d1bdf4d1-db48-41f5-9efe-51d50b1f06b0
Version: 1
Effective Time: 20240108
 
Laboratorios Calier S.A.