Pluset powder and solvent for solution for injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Luteinizing hormone (lhp); Follicle stimulating hormone (fshp); Luteinizing hormone (lhp); Follicle stimulating hormone (fshp)

Available from:

LABORATORIOS CALIER S.A.

ATC code:

QG03GA

INN (International Name):

Luteinizing hormone (lhp); Follicle stimulating hormone (fshp); Luteinizing hormone (lhp); Follicle stimulating hormone (fshp)

Dosage:

50/50 international unit(s)/millilitre

Pharmaceutical form:

Powder and solvent for solution for injection

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Cattle

Therapeutic area:

Gonadotropins

Therapeutic indications:

Hormone

Authorization status:

Authorised

Authorization date:

2008-09-26

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Pluset powder and solvent for solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
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)
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
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
Luteinizing 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
H
E
A
L
T
H
P
R
O
D
U
C
T
S
R
E
G
U
L
A
T
O
R
Y
A
U
T
H
O
R
I
T
Y
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
_D_
_a_
_t_
_e_
_ _
_P_
_r_
_i_
_n_
_t_
_e_
_d_
_ _
_3_
_1_
_/_
_0_
_5_
_/_
_2_
_0_
_1_
_6_
_C_
_R_
_N_
_ _
_7_
_0_
_2_
_3_
_3_
_0_
_6_
_p_
_a_
_g_
_e_
_ _
_n_
_u_
_m_
_b_
_e_
_r_
_:_
_ _
_1_
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN AN