Atopica vet.

1 x 5 ml

Oral solution

Active substance

Ciclosporin : 100 mg/ml

ATC code

QL04AD01 Ciclosporin

QL04AD Calcineurin inhibitors

QL04A Immunosuppressants

QL04 Immunosuppressants

QL Antineoplastic and immunomodulating agents

Species

Cats

Dogs (weighing more than 2 kg)

Indications

Symptomatic treatment of chronic allergic dermatitis in cats.

Treatment of chronic manifestations of atopic dermatitis in dogs.

Dose to be administered and administration route

For oral use.

Before starting treatment, an evaluation of all alternative treatment options should be made.

To ensure a correct dosage, body weight should be determined as accurately as possible.

Cats:

The recommended dose of ciclosporin is 7 mg/kg body weight (0.07 ml of oral solution per kg) and should initially be administered daily. The veterinary medicinal product should be administered in accordance with the following table:

Bodyweight (kg)	Dose (ml)
2	0.14
3	0.21
4	0.28
5	0.35
6	0.42
7	0.49
8	0.56
9	0.63
10	0.70

The frequency of administration should subsequently be reduced depending on the response.

The product should initially be given daily until a satisfactory clinical improvement is seen (assessed by intensity of pruritus and lesion severity - excoriations, miliary dermatitis, eosinophilic plaques and/or self-induced alopecia). This will generally be the case within 4-8 weeks.

Once the clinical signs of allergic dermatitis are satisfactorily controlled, the product can then be given every second day. In some cases where the clinical signs are controlled with every second day dosing, the veterinary surgeon can decide to give the product every 3 to 4 days. The lowest effective frequency of dosing should be used to maintain the remission of clinical signs.

Patients should be regularly re-evaluated and alternative treatment options reviewed. The duration of treatment should be adjusted according to treatment response. Treatment may be stopped when the clinical signs are controlled. Upon recurrence of clinical signs, treatment should be resumed at daily dosing, and in certain cases repeated treatment courses may be required.

The product can be given either mixed with food or directly into the mouth. If given with food, the solution should be mixed with a small amount of food, preferably after a sufficient period of fasting to ensure complete consumption by the cat. Should the cat not accept the product mixed with food, it should be given by inserting the syringe directly into the cat’s mouth and delivering the entire dose. In case the cat only partially consumes the product mixed with food, administration of the product with the syringe should be resumed only the next day.

The efficacy and tolerability of this product was demonstrated in clinical studies with a duration of 4.5 months.

Dogs:

The mean recommended daily dose of ciclosporin is 5 mg/kg body weight (0.05 ml of oral solution per kg). The veterinary medicinal product should be administered in accordance with the following table:

Bodyweight (kg)	Dose (ml)	Bodyweight (kg)	Dose (ml)	Bodyweight (kg)	Dose (ml)
		21	1.05	41	2.05
		22	1.10	42	2.10
3	0.15	23	1.15	43	2.15
4	0.20	24	1.20	44	2.20
5	0.25	25	1.25	45	2.25
6	0.30	26	1.30	46	2.30
7	0.35	27	1.35	47	2.35
8	0.40	28	1.40	48	2.40
9	0.45	29	1.45	49	2.45
10	0.50	30	1.50	50	2.50
11	0.55	31	1.55	51	2.55
12	0.60	32	1.60	52	2.60
13	0.65	33	1.65	53	2.65
14	0.70	34	1.70	54	2.70
15	0.75	35	1.75	55	2.75
16	0.80	36	1.80	56	2.80
17	0.85	37	1.85	57	2.85
18	0.90	38	1.90	58	2.90
19	0.95	39	1.95	59	2.95
20	1.00	40	2.00	60	3.00

The veterinary medicinal product will initially be given daily until a satisfactory clinical improvement is seen. This will generally be the case within 4 weeks. If no response is obtained within the first 8 weeks, the treatment should be stopped.

Once the clinical signs of atopic dermatitis are satisfactorily controlled, the veterinary medicinal product can then be given every other day as a maintenance dose. The veterinarian should perform a clinical assessment at regular intervals and adjust the frequency of administration to the clinical response obtained.

In some cases where the clinical signs are controlled with every-other-day dosing, the veterinarian can decide to give the veterinary medicinal product every 3 to 4 days.

Adjunct treatment (e.g. medicated shampoos, fatty acids) may be considered before reducing the dosing interval.

Treatment may be stopped when the clinical signs are controlled. Upon recurrence of clinical signs, treatment should be resumed at daily dosing, and in certain cases repeated treatment courses may be required.

The veterinary medicinal product should be given at least 2 hours before or after feeding. The product should be given by inserting the syringe directly into the dog’s mouth and delivering the entire dose.

Adverse reactions

Cats:

Very common

(>1 animal / 10 animals treated):

Digestive tract disorders (Vomiting, Diarrhoea)¹.

Common

(1 to 10 animals / 100 animals treated):

Lethargy², Anorexia², Weight loss²;

Hypersalivation²; Lymphopenia².

Very rare

(<1 animal / 10,000 animals treated, including isolated reports):

Leucopenia, Neutropenia, Thrombocytopenia; Diabetes mellitus.

¹generally mild and transient and do not require the cessation of the treatment.

²generally resolve spontaneously after treatment is stopped or following a decrease in the dosing frequency

Side effects may be severe in individual animals.

Dogs:

Uncommon

(1 to 10 animals / 1,000 animals treated):

Digestive tract disorders (Hypersalivation, Vomiting, Mucous stool, Loose stool, Diarrhoea)¹.

Rare

(1 to 10 animals / 10,000 animals treated):

Lethargy², Anorexia²;

Hyperactivity²;

Gingival hyperplasia^2,3;

Skin reactions (such as Verruciform lesions,

Hair change)²;

Pinnal reddening², Pinnal oedema²; Muscle weakness², Cramp².

Very rare

(<1 animal / 10,000 animals treated, including isolated reports):

Diabetes mellitus⁴.

¹generally mild and transient and do not require the cessation of the treatment

²generally resolve spontaneously after treatment is stopped

³mild to moderate

⁴mainly in West Highland White Terriers

Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or the national competent authority via the national reporting system. See also section 16 of the package leaflet for respective contact details.