Modulis 100 mg/ml oral solution for dogs

2. QUALITATIVE AND QUANTITATIVE COMPOSITION OF Modulis 100 mg/ml

Each ml contains:
Active substance:
Ciclosporin 100 mg

Excipient(s) Modulis 100 mg/ml :
all-rac-α-tocopherol (E-307) 1 mg

For the full list of excipients, see section 6.1. 100 mg/ml oral solution for dogs

2. QUALITATIVE AND QUANTITATIVE COMPOSITION OF

Each ml contains:
Active substance:
Ciclosporin 100 mg

Excipient(s)
all-rac-α-tocopherol (E-307) 1 mg

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM OF

Oral solution
Clear to slightly yellow opalescent solution.

4. CLINICAL PARTICULARS OF

4.1 Target species for

Dogs

4.2 Indications for use, specifying the target species

g/ml is used for the treatment of chronic cases of atopic dermatitis in dogs. The active substance in Modulis is 100 mg cyclosporin per ml. Modulis should be administered orally.

The average recommended dose cyclosporine is 5 mg/kg body weight (0,5 ml oral solution per 10 kg body weight).The veterinary medicament has to be administered at least 2 hours before or after feeding.

g/ml should be administered directly into the mouth, on the back of the tongue of the dog, using a measuring syringe provided in the package.

It is important to not use Modulis 100 mg/ml with dogs under the age of 6 months, or dogs that weigh less than 2 kg.

Dosage for Modulis 100 mg/ml:

The recommended average dose is 5 mg ciclosporin per kg body weight or 0.5 ml per 10 kg body weight.

The drug will be administered once daily until satisfactory clinical improvement is achieved. This is usually observed after 4 weeks of treatment. If no effect is obtained in the first 8 weeks, treatment should be discontinued.
Once the clinical signs of atopic dermatitis are correctly controlled, the specialty can then be administered every other day in a maintenance dose (0.5 ml / 10 kg).
The veterinarian will have to repeat his clinical evaluation at regular intervals and adapt the frequency of administration according to the clinical results obtained.
In some cases, when the clinical signs are correctly controlled with treatment every other day, the veterinarian may decide to prescribe the medicine every 3 to 4 days. Modulis 100 mg/ml is very good for horses and camel