Sporimune 50 mg/ml Oral Solution for Cats and Dogs, POM-V

Sporimune® 50 mg/ml Oral Solution for Cats and Dogs – Indications for use -Treatment of chronic manifestations of atopic dermatitis in dogs. Symptomatic treatment of chronic allergic dermatitis in cats.

Amounts to be administered and administration route

For oral use.

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

To ensure administration of the correct dosage body weight should be determined as accurately as possible.

At first use of Sporimune® 50 mg/ml Oral Solution for Cats and Dogs: replace the original screw cap of the bottle with the separately delivered screw cap. Fill the correct dosing syringe by pulling the plunger until it reaches the graduation corresponding to the correct body weight of the animal. After administration of the veterinary medicinal product close bottle tightly with cap, wash the measuring syringe with water and let it dry.

Dosage and method of administration of Sporimune® 50 mg/ml Oral Solution for Cats and Dogs

Dogs: The mean recommended dose of ciclosporin is 5 mg per kg body weight (0.25 ml oral solution per 2.5 kg body weight). The veterinary medicinal product should be given at least 2 hours before or after feeding.

The product should be administered directly into the dog’s mouth on the back of the tongue using the graduated dosing syringe supplied (1 ml oral solution contains 50 mg ciclosporin) and delivering the entire dose.

Cats: The recommended dose of ciclosporin is 7 mg/kg body weight (0.14 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 can be given either mixed with food or directly into the mouth. If given with food, the solution should be mixed with half the normal amount of food consumed using the graduated dosing syringe supplied. (1 ml oral solution contains 50 mg ciclosporin), preferably after a sufficient period of fasting to ensure complete consumption by the cat. When the medicated feed is fully consumed the rest of the food may be given.

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. If the cat only partially eats the product mixed with food, administration of the product directly into the mouth using the graduated dosing syringe must only be continued the next day.

Duration and frequency of administration

The product will initially be given daily until a satisfactory clinical improvement is seen (assessed by intensity of pruritis and lesion severity – excoriations, miliary dermatitis, eosinophilic plaques and/or self-induced alopecia). 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/allergic dermatitis are satisfactorily controlled, the preparation 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 3-4 days. The lowest effective frequency of dosing should be used to maintain the remission of clinical signs.

Adjunct treatment (e.g. medicated shampoos, fatty acids) may be considered before reducing the dosing interval. Patients should be regularly re-evaluated and alternative treatment options reviewed.

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.