Patient leaflet - Pruban
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Pruban 0.1 % cream for dogs
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance(s)
Resocortol butyrate
3. PHARMACEUTICAL FORM
White to off-white cream
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4. CLINICAL PARTICULARS
4.1 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
Special precautions for use in animals
Lesions should be systemic effects
itored closely for signs of infection. In case of diabetes mellitus, the potential oduct may influence glycaemia.
to be taken by the person administering the veterinary medicinal product to
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 Overdose
The maximum total surface of lesions (tre For example, the total surface area treated
ld 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
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10 DATE OF REVISION OF THE TEXT
11 PROHIBITION OF SALE,.SUPPLY AND/OR USE
Not applicable.
A.
MANUFACTURING AUTHORISA BATCH RELEASE
ANNEX II
OLDER(S) RESPONSIBLE FOR
B.
CONDITIONS OR RESTRIC
AUTHORISATION REGARD
OF THE MARKETING
SUPPLY OR USE
C.
CONDITIONS OR RESTRICTIONS OF THE MARKETING
AUTHORISATION WITH REGARD TO SAFE AND EFFECTIVE USE
STATEMENT OF
D.
RLs
A.
MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BAT RELEASE
Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands
B.
Veterinary medicinal product subject to prescription.
C.
Not applicable.
Not applicable.
CONDITIONS OR RESTRICTIONS OF THE MA
WITH REGARD TO SAFE AND EFFECTIVE U
The Ministerie van Landbouw, Natuurbeheer en Visserij confirmed that the manufacturing site was authorised under number 324-BVEAK for pharmaceutical products.
D. STATEMENT OF THE MRLs
G AUTHORISATION
CONDITIONS OF THE MARKETING AUTHORISATION IN RESTRICTIONS REGARDING SUPPLY AND USE
PARTICULARS TO APPEAR ON THE OUTER PACKAGE
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE
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1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Pruban 0.1 % cream for dogs
2. STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Resocortol butyrate 1mg/g
3. PHARMACEUTICAL FORM
Cream
4. PACKAGE SIZE
Tube containing 15 g of cream
-
5. TARGET SPECIES
Dog
6. INDICATION(S)
Treatment of acute localised moist dermatiti
Not applicable
8. WITHDRAWAL
7. METHOD AND ROUTE(
INISTRATION
plying it to the lesion.
9. SPECIAL WARNING(S), IF NECESSARY
This product belongs to the class of dermocorticoids. The therapeutic use of these substances in humans en recognised to induce local side effects such as skin thinning, skin weakness, delayed healing s and secondary infections.
Avoid contact with the product. Wear disposable gloves when applying the product. Wash hands after
UNUSED PRODUCTS OR WASTE
Do not use in dogs with extensive lesions. The maximum total surface of lesions (treated in cm2) shoul not exceed 10 times the body weight (in kg). For example, the total surface area treated of a dog weighi 5 kg should not exceed 50 cm2).
Do not use in dogs with infected lesions of bacterial, viral, fungal or parasitic origin or with ul lesions.
Do not use in animals suffering from Cushing’s syndrome.
Do not use in dogs used for breeding and in lactating or pregnant bitches.
Do not use in puppies under 6 months of age.
10. EXPIRY DATE
Month/Year
Once broached, use within 8 weeks
11. SPECIAL STORAGE CONDITIONS
Do not store above 25 °C
12. SPECIAL PRECAUTIONS FOR THE DISPOSA MATERIALS, IF ANY
Any unused veterinary medicinal product or waste material derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
13. THE WORDS "FOR ANIMAL TREATMENT ONLY" AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
For animal treatment only. To be supplied only on veterinary prescription.
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14. THE WORDS „KEEP OUT OF REACH AND SIGHT OF CHILDREN“
Keep out of reach and sight of children
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15. NAME AND A D DRESS OF THE MARKETING AUTHORISATION HOLDER
Intervet Internation Wim de Körverstra 5831 AN Boxmeer The Netherlands
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16. NUMBER(S) IN THE COMMUNITY REGISTER OF MEDICINAL PRODUCTS
ANUFACTURER'S BATCH NUMBER
For animal treatment only
Month\Year
Once broached, use within 8 weeks
6. EXPIRY DATE
7. THE WORDS "FOR ANI
ATMENT ONLY
PACKAGE INSERT
-
1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND THEMANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BAT RELEASE, IF DIFFERENT
Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands
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2. NAME OF THE VETERINARY MEDICINAL PRODUCT
Pruban 0.1 % cream for dogs
3. STATEMENT OF THE ACTIVE SUBSTANCE
Resocortol butyrate: 1mg/g
4. INDICATION
Treatment of acute localised moist dermatitis.
5. CONTRA-INDICATIONS
Do not use in dogs with extensive lesions. The maximum total surface of lesions (treated in cm2) should not exceed 10 times the body weight (in kg). For example, the total surface area treated of a dog weighing 5 kg should not exceed 50 cm2).
6. ADVERSE REAC
Do not use in dogs with infected lesions lesions.
Do not use in animals suffering fro
Do not use in dogs used for breedi
Do not use in puppies under 6 m
rial, viral, fungal or parasitic origin or with ulcerated
ing’s syndrome.
in lactating or pregnant bitches.
age.
On rare occasions hypera the treated area has been observed. Lesions should be monitored closely for signs of infection. In case of diabetes mellitus, the potential systemic effects of the product may influence glycaemia.
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.
7.
ET SPECIES
8. DOSAGE FOR EACH SPECIES, ROUTE AND METHOD OF ADMINISTRATION
For topical administration to the skin.
Apply a 1 cm strip (0.2 g) of cream per 10 cm2 of lesion.
9. ADVICE ON CORRECT ADMINISTRATION
During initial treatment apply the cream twice daily. Treat for 7 to 14 days. The ent 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 efficacy). /XT
The dog should be re-examined by the veterinarian, if the lesion is not cured after 14 days of treatment.
10. WITHDRAWAL PERIOD
Not applicable
11. SPECIAL STORAGE PRECAUTIONS
Keep out of the reach and sight of children.
Do not store above 25 °C.
Shelf life after first opening of the tube: 8 weeks
12. SPECIAL WARNINGS
After topical application on the skin, a lo
a moderate and reversible adrenal systemic effects were observed.
i-inflammatory effect is seen, which is accompanied by at higher doses. After oral administration in dogs few
Since glucocorticosteroids can sl and large lesions should not be
This product belongs to the class humans has been recognised to in
suppr
h, use in young, growing animals should be well controlled
healing process and secondary infections.
dermocorticoids. The therapeutic use of these substances in duce local side effects such as skin thinning, skin weakness, delayed
Avoid contact with the product. Wear disposable gloves when applying the product. Wash hands after use.
13. SPE ME
CAUTIONS FOR THE DISPOSAL OF UNUSED VETERINARY L PRODUCT OR WASTE MATERIALS IF ANY
Any unused veterinary medicinal product or waste material derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
ATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
15. OTHER INFORMATION
Resocortol butyrate is a corticosteroid which has a high intrinsic glucocorticoid activity. Its mineralocorticoid and progestational activity is very low. Resocortol butyrate has local and s glucocorticoid effects. The expression of these effects depends on the mode of application an dosage applied.
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