Vulketan 2.5 mg/g gel for horses

البلد: أيرلندا

اللغة: الإنجليزية

المصدر: HPRA (Health Products Regulatory Authority)

العنصر النشط:

Ketanserin tartrate

متاح من:

Elanco Animal Health, Eli Lilly and Company Limited

ATC رمز:

QD03AX90

INN (الاسم الدولي):

Ketanserin tartrate

جرعة:

2.5 milligram(s)/gram

الشكل الصيدلاني:

Gel

نوع الوصفة الطبية :

POM: Prescription Only Medicine as defined in relevant national legislation

المجموعة العلاجية:

Horses

المجال العلاجي:

ketanserin

الخصائص العلاجية:

Miscellaneous

الوضع إذن:

Authorised

تاريخ الترخيص:

2012-06-01

خصائص المنتج

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