Vulketan 2.5 mg/g gel for horses

Land: Irland

Språk: engelska

Källa: HPRA (Health Products Regulatory Authority)

Aktiva substanser:

Ketanserin tartrate

Tillgänglig från:

Elanco Animal Health, Eli Lilly and Company Limited

ATC-kod:

QD03AX90

INN (International namn):

Ketanserin tartrate

Dos:

2.5 milligram(s)/gram

Läkemedelsform:

Gel

Receptbelagda typ:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapeutisk grupp:

Horses

Terapiområde:

ketanserin

Terapeutiska indikationer:

Miscellaneous

Bemyndigande status:

Authorised

Tillstånd datum:

2012-06-01

Produktens egenskaper

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Vulketan 2.5 mg/g gel for horses
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
3 PHARMACEUTICAL FORM
Gel
Clear transparent sterile gel.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Horses
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
•
To encourage wound healing
•
Prevention of the formation of hyper-granulation tissue
4.3 CONTRAINDICATIONS
Do not use for deep (e.g. penetrating or puncture wounds) or infected
wounds, or immediately following surgery.
Do not use in known cases of hypersensitivity to the active substance
or to any of the excipients.
Do not apply in eyes and on mucous membranes.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None
Each g of gel contains:
ACTIVE SUBSTANCE:
Ketanserin tartrate
3.45 mg
(equivalent to 2.5 mg ketanserin)
EXCIPIENT(S)
Methyl parahydroxybenzoate (E218)
1.35 mg
Propyl parahydroxybenzoate
0.15 mg
For the 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_
_ _
_2_
_9_
_/_
_0_
_7_
_/_
_2_
_0_
_1_
_6_
_C_
_R_
_N_
_ _
_7_
_0_
_2_
_2_
_6_
_2_
_1_
_p_
_a_
_g_
_e_
_ _
_n_
_u_
_m_
_b_
_e_
_r_
_:_
_ _
_1_
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
In view of its stimulating effect on microcirculation the product
should not be applied on fresh wounds until
bleeding has stopped.
If exuberant
granulation tissue (proud flesh) has already developed in older
wounds,
it
should be surgically
removed before treatment is