Vulketan 2.5 mg/g Gel for Horses

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Ketanserin

Available from:

Eli Lilly and Company Limited

ATC code:

QD03AX90

INN (International Name):

Ketanserin

Pharmaceutical form:

Gel

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Horses

Therapeutic area:

Anti Inflammatory

Authorization status:

Authorized

Authorization date:

2011-07-27

Summary of Product characteristics

Revised August 2016
AN: 01349/2015
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Vulketan 2.5 mg/g gel for horses [AT, DE, FR, IE, IT, LU, NL, PT, UK]
Vulketan vet 2.5 mg/g gel for horses [DK, FI, IS, SE]
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
EACH G OF GEL CONTAINS:
ACTIVE SUBSTANCE:
Ketanserin tartrate
(equivalent to 2.5 mg ketanserin)
3.45 mg
EXCIPIENT(S):
Methyl parahydroxybenzoate (E218)
1.35 mg
Propyl parahydroxybenzoate
0.15 mg
For the full list of excipients, see section 6.1.
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
None
Page 1 of 4
Revised August 2016
AN: 01349/2015
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 started.
-
Stabled horses with leg wounds may develop oedema so they should be
allowed
some outside exercise during treatment.
-
In order to facilitate twice daily treatment it is not recommended to
bandage the
wounds when being treated with the product.
-
Wash the wound with clear warm water prior to each treatment to remove
the film
of gel which forms over the wound.
-
Remove any sequestors or necrotic tissue from the wound prior to
treatment with
the product.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
VETERINARY
MED