Cortavance
hydrocortisone aceponate
Marketing authorisation holder and manufacturer:
VIRBAC
1ère avenue 2065 m LID 06516 Carros FRANCE
CORTAVANCE 0.584 mg/ml cutaneous spray solution for dogs Hydrocortisone aceponate
Hydrocortisone aceponate 0.584 mg/ml.
For symptomatic treatment of inflammatory and pruritic dermatoses in dogs. For alleviation of clinical signs associated with atopic dermatitis in dogs.
Do not use on cutaneous ulcers.
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
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.
Dogs.
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/cm2 of affected skin per day. This
dosage can be achieved with two pump spray activations over a surface to be treated equivalent to a square of 10 cm x 10 cm.
For treatment of inflammatory and pruritic dermatoses, repeat the treatment daily for 7 consecutive days.
In case of conditions requiring an extended treatment, the responsible veterinarian should subject the use of the veterinary medicinal product to the risk-benefit assessment.
If signs fail to improve within 7 days, treatment should be re-evaluated by the veterinarian.
For alleviation of clinical signs associated with atopic dermatitis, repeat the treatment daily for at least 14 and up to 28 consecutive days.
An intermediary control by the veterinarian at day 14 should be made to decide if further
treatment is needed. The dog should be re-evaluated regularly with regard to HPA suppression or skin atrophy, both being possibly asymptomatic.
Any prolonged use of this product, to control atopy, should be at the benefit risk assessment of
the responsible veterinary surgeon. It should take place after a re-evaluation of the diagnosis and also a consideration of the multi-modal treatment plan in the individual animal.
Presented as a volatile spray, this veterinary medicinal product does not require any massage.
Not applicable.
Keep out of the sight and reach of children.
This veterinary medicinal product does not require any special storage conditions.
Do not use this veterinary medicinal product after the expiry date which is stated on the label. Shelf-life after first opening the container: 6 months.
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 and the thighs. See also section “Overdose”. Otherwise, use only according to the risk-benefit assessment of the responsible veterinary surgeon and subject the dog to regular clinical evaluations as further described in section “Dosage for each species, route(s) and method of administration”.
Care should be taken to avoid spraying into the eyes of the animal.
Special precautions to be taken by the person administering the veterinary medicinal product to animals:
The active substance is potentially pharmacologically active at high doses of exposure. The formulation may cause eye irritation following accidental ocular contact.
The formulation is flammable.
Wash hands after use. Avoid contact with eyes.
To avoid skin contact, recently treated animals should not be handled until the application site is dry. To avoid inhalation of the product, apply the spray in a well-ventilated area.
Do not spray on naked flame or any incandescent material.
Do not smoke while handling the veterinary medicinal product.
Replace the bottle in the outer carton and in a safe place out of the sight and the reach of children immediately after use.
In case of accidental skin contact, avoid hand-to-mouth contact and wash the exposed area immediately with water.
In case of accidental eye contact, rinse with abundant quantities of water. If eye irritation persists, seek medical advice.
In case of accidental ingestion, especially by children, seek medical advice immediately and show the leaflet or the label to the physician.
Pregnancy and lactation:
The safety of the veterinary medicinal product has not been established during pregnancy and lactation. Systemic absorption of hydrocortisone aceponate being negligible, it is unlikely for teratogenic, foetotoxic, maternotoxic effects to happen at the recommended dosage in dogs. Use only accordingly to the risk-benefit assessment by the responsible veterinarian.
Interaction with other medicinal products and other forms of interaction:
In the absence of information, it is recommended not to apply other topical preparations simultaneously on the same lesions.
Overdose (symptoms, emergency procedures, antidotes):
Tolerance studies of multiple doses were assessed over a period of 14 days in healthy dogs using 3 and 5 times the recommended dosage corresponding to the two flanks, from the spine to the mammary chains including the shoulder and the thighs (1/3 of the dog’s body surface area). These resulted in a reduced capacity for production of cortisol that is fully reversible within 7 to 9 weeks after the end of treatment.
In 12 dogs suffering from atopic dermatitis, after topical application once a day at the recommended therapeutic dosage for 28 to 70 (n=2) consecutive days, no noticeable effect on the systemic cortisol level was observed.
Other precautions:
The solvent in this product may stain certain materials including painted, varnished or other household surfaces or furnishings. Allow the application site to dry before permitting contact with such materials.
Medicines should not be disposed of via wastewater or household waste.
Ask your veterinary surgeon or pharmacist how to dispose of medicines no longer required. These measures should help to protect the environment.
Hydrocortisone aceponate administered topically accumulates and is metabolised in skin, as suggested by radioactivity distribution studies and pharmacokinetic data. This results in minimal amounts to reach the blood stream. This particularity will increase the ratio between the desired local anti- inflammatory effect in the skin and the undesirable systemic effects.
Hydrocortisone aceponate applications on the skin lesions provide rapid reduction of the skin redness, irritation and scratching while minimising the general effects.
Pack sizes:
Carton box with a PET bottle of 31 ml Carton box with a PET bottle of 76 ml Carton box with a HDPE bottle of 31 ml Carton box with a HDPE bottle of 76 ml
Not all pack size may be marketed.
For any information about this veterinary medicinal product, please contact the local representative of the marketing authorisation holder.
VIRBAC Österreich GmbH
Hildebrandgasse 27
1180 Wien Österreich
Tel: +43-(0)1 21 834 260
3001 Leuven
België / Belgique / Belgien Tel: +32-(0)16 387 260
VIRBAC
1ère avenue 2065 m LID 06516 Carros
Франция
Teл: +33-(0)4 92 08 73 00
VIRBAC Hellas SA
13o χλμ Ε.Ο. Αθηνών – Λαμίας,
T.K.14452, Μεηαμόρθωζη, Ελλάδα
Τηλ. : +30-210 6219520
VIRBAC
1ère avenue 2065 m LID 06516 Carros
Francie
Tel: +33-(0)4 92 08 73 00
VIRBAC Tierarzneimittel GmbH Rögen 20
23843 Bad Oldesloe Deutschland
Tel: +49-(4531) 805 111
VIRBAC Danmark A/S Profilvej 1 6000
Kolding Danmark
Tel: +45 75521244
VIRBAC
1ère avenue 2065 m LID 06516 Carros
Prantsusmaa
Tel: +33-(0)4 92 08 73 00
VIRBAC España SA Angel Guimerá 179-181
08950 Esplugues de Llobregat (Barcelona)
España
Tel. : + 34-(0)93 470 79 40
VIRBAC
1ère avenue 2065 m LID 06516 Carros
Ranska
Tel: + 33-(0)4 92 08 73 00
VIRBAC Hellas SA
13o χλμ Ε.Ο. Αθηνών – Λαμίας, T.K.14452, Μεηαμόρθωζη, Ελλάδα
Τηλ. : +30-210 6219520
VIRBAC
1ère avenue 2065 m LID 06516 Carros
Francuska
Tel: + 33-(0)4 92 08 73 00
Teл: +36703387177
VIRBAC
1ère avenue 2065 m LID 06516 Carros
France
Tel: + 33 (0) 4 92 08 73 00
VIRBAC
1ère avenue 2065 m LID 06516 Carros
Frakkland
Tel: + 33-(0)4 92 08 73 00
VIRBAC SRL
Via Ettore Bugatti, 15 20142 Milano
Italia
Tel: + 39 02 40 92 47 1
VIRBAC
1ère avenue 2065 m LID 06516 Carros
Prancūzija
Tel: +33-(0)4 92 08 73 00
3001 Leuven Belgique / Belgien
Tel: +32-(0)16 387 260
VIRBAC
1ère avenue 2065 m LID 06516 Carros
Francija
Tel: +33-(0)4 92 08 73 00
VIRBAC
1ère avenue 2065 m LID 06516 Carros
Franza
Tel: + 33-(0)4 92 08 73 00
3771 ND-Barneveld Nederland
Tel : +31-(0)342 427 127
Profilvej 1
6000 Kolding Danmark
Tel: + 45 75521244
VIRBAC de Portugal Laboratórios LDA R.do Centro Empresarial
Ed13-Piso 1- Esc.3
Quinta da Beloura PT-2710-693 Sintra
Tel: + 351 219 245 020
VIRBAC
1ère avenue 2065 m LID FR-06516 Carros
Francija
Tel : + 33-(0)4 92 08 73 00
VIRBAC Danmark A/S Filial Sverige SE-171 21 Solna
Tel: +45 75521244
VIRBAC Sp. z o.o.
ul. Puławska 314
02 - 819 Warszawa Polska
Tel.: + 48 22 855 40 46
VIRBAC
1ère avenue 2065 m LID FR-06516 Carros
Franţa
Tel: + 33-(0)4 92 08 73 00
VIRBAC
1ère avenue 2065 m LID FR-06516 Carros
Francúzsko
Tel: + 33-(0)4 92 08 73 00
VIRBAC
1ère avenue 2065 m LID FR-06516 Carros
France
Tel: +33-(0)4 92 08 73 00