Pruban
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
26-07-2010
Charakterystyka produktu
(SPC)
26-07-2010
Sprawozdanie z oceny publicznego
(PAR)
26-07-2010
Składnik aktywny:
resocortol butyrate
Dostępny od:
Intervet International BV
Kod ATC:
QD07AC90
INN (International Nazwa):
resocortol butyrate
Grupa terapeutyczna:
Dogs
Dziedzina terapeutyczna:
Corticosteroids, dermatological preparations
Wskazania:
Treatment of acute localised moist dermatitis.
Podsumowanie produktu:
Revision: 4
Status autoryzacji:
Withdrawn
Data autoryzacji:
2000-11-16
Ulotka dla pacjenta
Medicinal product no longer authorised
12/15
B. PACKAGE INSERT
Medicinal product no longer authorised
13/15
PACKAGE INSERT
1.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF
THEMANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE, IF DIFFERENT
Intervet International B.V.
Wim de Körverstraat 35
5831 AN Boxmeer
The Netherlands
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 cm
2
) 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 cm
2
).
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 dogs used for breeding and in lactating or pregnant
bitches.
Do not use in puppies under 6 months of age.
6.
ADVERSE REACTIONS
On rare occasions hyperaemia of 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.
TARGET SPECIES
Dogs.
Medicinal product no longer authorised
14/15
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 cm
2
of lesion.
9.
ADVICE ON CORRECT ADMINISTRATION
During initial treatment apply the cream twice daily. 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
applicati
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Charakterystyka produktu
Medicinal product no longer authorised
1/15
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2/15
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Pruban 0.1 % cream for dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE(S)
Resocortol butyrate
1 mg/g
3.
PHARMACEUTICAL FORM
White to off-white cream
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs
4.2
INDICATIONS FOR USE
Treatment of acute localised moist dermatitis.
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 TARGET SPECIES
Since glucocorticosteroids can slow growth, use in young, growing
animals should be well controlled
and large lesions should not be treated.
4.5
SPECIAL PRECAUTION(S) FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Lesions should be monitored closely for signs of infection. In case of
diabetes mellitus, the potential
systemic effects of the product may influence glycaemia.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
VETERINARY MEDICINAL PRODUCT TO
ANIMALS
This product belongs to the class of dermocorticoids. The therapeutic
use of these substances in
humans has been recognised to induce local side effects such as skin
thinning, skin weakness, delayed
healing process and secondary infections.
Avoid contact with the product. Wear disposable gloves when applying
the product. Wash hands after
use.
Medicinal product no longer authorised
3/15
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
OF INTERACTION
Do not apply other topical preparations concomitantly to the same
lesions
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