Summary of medicine characteristics - Pruban
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Pruban 0.1 % cream for dogs
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Resocortol butyrate
3. PHARMACEUTICAL FORM
White to off-white cream
4. CLINICAL PARTICULARS4.1 Target species
Dogs
4.2 Indications for use
Treatment of acute localised moist dermatitis.
1 mg/g
4.3 Contra-indications
Do not use in dogs with extensive lesions.
Do not use in dogs with infected lesions of bacterial, viral, fungal or parasitic origin or with ulcerated lesions.
Do not use in animals suffering from Cushing’s syndrome.
Do not use in puppies under 6 months of age.
4.4 Special warnings for each
cies
se
Since glucocorticosteroids can and large lesions should not be treated.
wth, use in young, growing animals should be well controlled
4.5 Special precaution
Lesions should be systemic effects
itored closely for signs of infection. In case of diabetes mellitus, the potential oduct may influence glycaemia.
hum heali
Special prec animals
belongs to the class of dermocorticoids. The therapeutic use of these substances in een recognised to induce local side effects such as skin thinning, skin weakness, delayed cess and secondary infections.
id contact with the product. Wear disposable gloves when applying the product. Wash hands after
4.6 Adverse reactions (frequency and seriousness)
On rare occasions hyperaemia of the treated area has been observed.
4.7 Use during pregnancy and lactation
Do not use in dogs for breeding nor in lactating or pregnant bitches.
4.8 Interaction with other veterinary medicinal products and other forms
Do not apply other topical preparations concomitantly to the same lesions.
4.9 Amounts to be administered and administration route
During initial treatment apply the cream twice daily. Apply a 1 cm strip (0.2 g) of cream per 10 cm2 of lesion. Treat for 7 to 14 days. The treatment period should not exceed 14 days. Clean the affected areas and clip the hair covering the lesions before application. Wearing disposable gloves, apply the cream gently to the lesion. It is recommended that the animal be distracted for several minutes following treatment to prevent licking (oral absorption of the cream is not harmful to the dog, but removal of the cream by licking directly after treatment might decrease efficac
The dog should be re-examined by the veterinarian if the les
is not cured after 14 days of treatment.
4.10 OverdoseThe maximum total surface of lesions (tre For example, the total surface area treatedld not exceed 10 times the body weight (in kg). g 5 kg should not exceed 50 cm2).
Overdosing, i.e. application rate of more than twice a day, or extension of the duration of treatment, increases the risk of glucocorticoid systemic effects particularly when administered on extensive lesions.
4.11 Withdrawal periods
Not applicable.
5. PHARMACOLOGI
OPERTIES
Pharmacotherapeutic group: Glucocorticosteroid, ATCvet code: QD07AC90.
Pruban contains the active principle resocortol butyrate. Resocortol butyrate is a corticosteroid which has a high intrinsiorticoid activity. Its mineralocorticoid and progestational activity is very
6.
ACEUTICAL PARTICULARS
ncompatibilities
low.
Resocortol but depends on local anti-i suppressi
s local and systemic glucocorticoid effects. The expression of these effects of application and the dosage applied. After topical application on the skin, a tory effect is seen, which is accompanied by a moderate and reversible adrenal gher doses. After oral administration in dogs few systemic effects were observed.
one known.
6.2 Shelf-life
-
24 months.
Shelf-life after first opening of the tube: 8 weeks.
6.3 Special precautions for storage
Do not store above 25 °C.
6.4 Nature and composition of immediate packaging
Collapsible aluminium tube containing 15 g cream, sealed with aluminium and closed with a polyethylene screw cap, packed in cardboard boxes, one tube per box.
f th , f „ ,. ,
6.5 Special precautions for the disposal of unused veterinary medicinal products or waste materials derived from such medicinal products
Any unused veterinary medicinal product or waste material derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
7. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Intervet International B.V.
Wim de Korverstraat 35
5831 AN Boxmeer
The Netherlands
8. MARKETING AUTHORISATION NUMBER(S)
EU/2/00/024/001
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
16.11.2000