Hydrocortisone aceponate Ecuphar (previously Cortacare)

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

hydrocortisone aceponate

Available from:

Ecuphar

ATC code:

QD07AC

INN (International Name):

hydrocortisone aceponate

Therapeutic group:

Dogs

Therapeutic area:

Corticosteroids, dermatological preparations

Therapeutic indications:

For symptomatic treatment of inflammatory and pruritic dermatoses in dogs.For alleviation of clinical signs associated with atopic dermatitis in dogs.

Product summary:

Revision: 3

Authorization status:

Authorised

Authorization date:

2018-08-27

Patient Information leaflet

15
B. PACKAGE LEAFLET
16
PACKAGE LEAFLET:
HYDROCORTISONE ACEPONATE ECUPHAR 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:
Ecuphar NV
Legeweg 157-i
8020 Oostkamp
Belgium
Manufacturer responsible for batch release:
DIVASA-FARMAVIC, S.A.
Ctra. Sant Hipòlit, km 71
08503 Gurb-Vic, Barcelona
Spain
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Hydrocortisone aceponate Ecuphar 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.
Clear colourless to slightly yellow solution.
4.
INDICATION(S)
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).
17
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.
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

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Hydrocortisone aceponate Ecuphar 0.584 mg/ml cutaneous spray solution
for dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml of solution contains:
ACTIVE SUBSTANCE
Hydrocortisone aceponate
0.584 mg
Equivalent to 0.460 mg of hydrocortisone
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Cutaneous spray, solution.
Clear colourless to slightly yellow 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 animals suffering
from Cushing’s syndrome shall be
based on the risk-benefit assessment.
3
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
and the thighs. See also section 4.10. Other