Cyclance vet.

For oral use.

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

Before administration, the body weight of animals has to be accurately determined.

Dogs:

The recommended dose of ciclosporin is 5 mg/kg body weight (0.05 ml of oral solution per kg BW) and should initially be administered daily. The frequency of administration should subsequently be reduced depending on the response.

The veterinary medicinal product should initially be given daily until a satisfactory clinical improvement is seen. This will generally be the case within 4-8 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 second day. 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 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. Adjunct treatment (e.g. medicated shampoos, fatty acids) may be considered before reducing the dosing interval.

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.

Dosages for dogs:

At standard dosage of 5mg/kg

For the 30 and 60 ml bottles, either the 1 ml oral syringe (graduated every 0.05 ml) or the 2 ml oral syringe (graduated every 0.1 ml) can be used to achieve the dose stated above, determined according to bodyweight.

For the 30 and 50 ml bottles, either the 1 ml oral syringe (graduated every 0.05 ml) or the 3 ml oral syringe (graduated every 0.1 ml) can be used to achieve the dose stated above, determined according to bodyweight.

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

The veterinary medicinal 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 48 weeks. Severe prolonged pruritus may induce a state of anxiety and subsequent excessive grooming behaviour. In such cases, despite an improvement in pruritus upon administration of the treatment, the resolution of self-induced alopecia may be delayed.

Once the clinical signs of allergic dermatitis are satisfactorily controlled, the veterinary medicinal 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 veterinary medicinal 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 oral 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 veterinary medicinal product with the oral syringe should be resumed only the next day. Any uneaten medicated cat food must be disposed of immediately and the bowl washed thoroughly.

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

Dosage for cats:

As the efficacy and safety of ciclosporin have not been assessed in cats weighing less than 2.3 kg (see section 4.5), administration of the veterinary medicinal product to cats weighing less than 2.3 kg should be according to a benefit-risk assessment by the responsible veterinarian.

At standard dosage of 7 mg/kg

For the 30 and 60 ml bottles, either the 1 ml oral syringe (graduated every 0.05 ml) or

the 2 ml oral syringe (graduated every 0.1 ml) can be used to achieve the dose stated above, determined according to bodyweight.

For the 30 and 50 ml bottles, either the 1 ml oral syringe (graduated every 0.05 ml) or the 3 ml oral syringe (graduated every 0.1 ml) can be used to achieve the dose stated above, determined according to bodyweight.

Dogs: The veterinary medicinal product should be given at least 2 hours before or after feeding. Insert the oral syringe directly into the dog’s mouth.

Cats: The product can be given either mixed with food or directly into the mouth in cats.

Keep out of the sight and reach of children

If necessary, the user can wipe the outside of the oral syringe with a dry tissue and dispose of used tissue immediately.