Vulketan 2.5 mg/g gel for horses

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Ketanserin tartrate

Available from:

Elanco Animal Health, Eli Lilly and Company Limited

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 group:

Horses

Therapeutic area:

ketanserin

Therapeutic indications:

Miscellaneous

Authorization status:

Authorised

Authorization date:

2012-06-01

Summary of Product characteristics

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.
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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