Pluset Powder and Solvent for Solution for Injection

Riik: Suurbritannia

keel: inglise

Allikas: VMD (Veterinary Medicines Directorate)

Toimeaine:

Follicle Stimulating Hormone (porcine), Luteinising Hormone (Porcine)

Saadav alates:

Laboratorios Calier, SA

ATC kood:

QG03GA90

INN (Rahvusvaheline Nimetus):

Follicle Stimulating Hormone (porcine), Luteinising Hormone (Porcine)

Ravimvorm:

Powder and solvent for solution for injection

Retsepti tüüp:

POM-V - Prescription Only Medicine – Veterinarian

Terapeutiline rühm:

Cattle

Terapeutiline ala:

Hormone sex

Volitamisolek:

Authorized

Loa andmise kuupäev:

2004-02-19

Toote omadused

Revised: August 2016
AN: 01697/2015
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
PLUSET Powder and solvent for solution for injection.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
One vial of lyophilized product contains :
Active substances:
- Follicle stimulating hormone (FSHp)
............................................500 IU
- Luteinizing hormone (LHp)
...........................................................500 IU
One vial of solvent contains:
-
Chlorocresol................................................................................0.021
g
- Sterile, pyrogen-free, normal saline to
...........................................21 ml
_Each ml of reconstituted solution contains:_
_ACTIVE SUBSTANCE:_
_Follicle stimulating hormone
(FSHp)...........................................................50
IU_
_Luteinising hormone (LHp)
.........................................................................50
IU _
_EXCIPIENTS:_
_Chlorocresol...............................................................................................
1 mg_
_Sterile, pyrogen-free, normal saline
to.........................................................1 ml_
For a full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
Powder and solvent for solution for injection.
White to off-white lyophilised pellet and clear and colourless
solution.
4. CLINICAL PARTICULARS
4.1. TARGET SPECIES
Cattle (reproductively mature females)
Revised: August 2016
AN: 01697/2015
4.2.
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
To induce superovulation in reproductively mature heifers or cows.
4.3.
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.
See section 4.7.
4.4.
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None
4.5.
SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
The following recommendations for the use of this product for the
induction of
superovulation with adequate r