Cortavance
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
24-09-2021
Charakterystyka produktu
(SPC)
24-09-2021
Sprawozdanie z oceny publicznego
(PAR)
24-09-2021
Składnik aktywny:
hydrocortisone aceponate
Dostępny od:
Virbac S.A.
Kod ATC:
QD07AC16
INN (International Nazwa):
hydrocortisone aceponate
Grupa terapeutyczna:
Dogs
Dziedzina terapeutyczna:
Corticosteroids, dermatological preparations
Wskazania:
For symptomatic treatment of inflammatory and pruritic dermatoses in dogs.For alleviation of clinical signs associated with atopic dermatitis in dogs.
Podsumowanie produktu:
Revision: 9
Status autoryzacji:
Authorised
Data autoryzacji:
2007-01-09
Ulotka dla pacjenta
18
B. PACKAGE LEAFLET
19
PACKAGE LEAFLET
CORTAVANCE 0.584 MG/ML CUTANEOUS SPRAY SOLUTION FOR DOGS
1.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE, IF DIFFERENT
Marketing authorisation holder and manufacturer:
VIRBAC
1
ère
avenue 2065 m LID
06516 Carros
FRANCE
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
CORTAVANCE 0.584 mg/ml cutaneous spray solution for dogs
Hydrocortisone aceponate
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Hydrocortisone aceponate
0.584 mg/ml.
4.
INDICATIONS
For symptomatic treatment of inflammatory and pruritic dermatoses in
dogs.
For alleviation of clinical signs associated with atopic dermatitis in
dogs.
5.
CONTRAINDICATIONS
Do not use on cutaneous ulcers.
Do not use in cases of hypersensitivity to the active substance or to
any of the excipients.
6.
ADVERSE REACTIONS
Transient local reactions at the application site (erythema and/or
pruritus) can occur in very rare cases.
The frequency of adverse reactions is defined using the following
convention:
- very common (more than 1 in 10 animals treated displaying adverse
reaction(s))
- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less than 10 animals in 1,000 animals
treated)
- rare (more than 1 but less than 10 animals in 10,000 animals
treated)
- very rare (less than 1 animal in 10,000 animals treated, including
isolated reports)
If you notice any side effects, even those not already listed in this
package leaflet or you think that the
medicine has not worked, please inform your veterinary surgeon.
7.
TARGET SPECIES
Dogs.
20
8.
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
Cutaneous use.
Before administration, screw the pump spray on the bottle.
The veterinary medicinal product is then applied by activating the
pump spray, from a distance of
about 10 cm of the area to be treated.
The recommended dosage is 1.52 µg of hydrocortisone aceponate/cm
2
of affected skin per day
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Charakterystyka produktu
1
_ _
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
CORTAVANCE 0.584 mg/ml cutaneous spray solution for dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
Hydrocortisone aceponate
0.584 mg/ml
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Cutaneous spray, solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For symptomatic treatment of inflammatory and pruritic dermatoses in
dogs.
For alleviation of clinical signs associated with atopic dermatitis in
dogs.
4.3
CONTRAINDICATIONS
Do not use on cutaneous ulcers.
Do not use in cases of hypersensitivity to the active substance or to
any of the excipients.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Clinical signs of atopic dermatitis such as pruritus and skin
inflammation are not specific for this
disease and therefore other causes of dermatitis such as ectoparasitic
infestations and infections which
cause dermatological signs should be ruled out before treatment is
started, and underlying causes
should be investigated.
In the case of concurrent microbial disease or parasitic infestation,
the dog should receive appropriate
treatment for such condition.
In the absence of specific information, the use in animal suffering
from Cushing’s syndrome shall be
based on the risk-benefit assessment.
Since glucocorticosteroids are known to slow growth, use in young
animals (under 7 months of age)
shall be based on the risk-benefit assessment and subject to regular
clinical evaluations.
Total body surface treated should not exceed approximately 1/3 of the
dog’s surface corresponding for
example to a treatment of two flanks from the spine to the mammary
chains including the shoulders
3
and the thighs. See also section 4.10. Otherwise, use only according
to the risk-benefit assessment of
the responsible veterinary surgeon and subject the dog to regular
clinica
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