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

PLUSET by

Drug Labeling and Warnings

PLUSET by is a Animal medication manufactured, distributed, or labeled by Laboratorios Calier S.A.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:

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 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 lyophilized powder vial label

PLUSET Solvent vial label

PLUSET Carton Label

INGREDIENTS AND APPEARANCE

PLUSET 
porcine follicle stimulating hormone, porcine luteinizing hormone kit kit

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	Item Code (Source)	NDC: 76307-101

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76307-101-01	1 in 1 CARTON

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	2 VIAL, MULTI-DOSE	20 mL
Part 2	1 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 Administration	INTRAMUSCULAR

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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 HORMONE	50 [iU]  in 1 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76307-201-02	10 mL in 1 VIAL, MULTI-DOSE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		01/10/2024

Part 2 of 2

PLUSET SOLVENT 
physiological saline injection

Product Information
Item Code (Source)	NDC: 76307-301
Route of Administration	INTRAMUSCULAR

Inactive Ingredients
Ingredient Name	Strength
CHLOROCRESOL (UNII: 36W53O7109)	0.021 g  in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76307-301-03	21 mL in 1 VIAL, GLASS

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		01/10/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		01/10/2024

Labeler - Laboratorios Calier S.A. (460009038)

Establishment
Name	Address	ID/FEI	Business Operations
Laboratorios Calier S.A.		460009038	analysis, manufacture, api manufacture, pack, label