Vulketan 2.5 mg/g gel for horses

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Ketanserin tartrate

Available from:

AUDEVARD

ATC code:

QD03AX90

INN (International Name):

Ketanserin tartrate

Dosage:

2.5 milligram(s)/gram

Pharmaceutical form:

Gel

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

ketanserin

Authorization status:

Authorised

Authorization date:

2012-06-01

Summary of Product characteristics

Health Products Regulatory Authority
30 August 2019
CRN0098K3
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Vulketan 2.5 mg/g gel for horses
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
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.
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
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.
Health Products Regulatory Authority
30 August 2019
CRN0098K3
Page 2 of 4
- 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 MEDICINAL