Modulis 100 mg/ml

Modulis 100 mg/ml

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.

3. PHARMACEUTICAL FORM

Oral solution
Clear to slightly yellow opalescent solution.

4. CLINICAL PARTICULARS OF Modulis 100 mg/ml

4.1 Target species for Modulis 100 mg/ml

Dogs

4.2 Indications for use, specifying the target species

Modulis 100mg/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.

Modulis 100 mg/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 

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

Treatment can be stopped when clinical signs are controlled. In case of recurrence of these signs, treatment should be resumed in daily doses, and in some cases repeated courses of treatment may be necessary.
Adjunctive therapy (eg, medicated shampoos, essential fatty acids) may be considered before reducing the dosing interval. Modulis 100 mg/ml
The drug should be given at least 2 hours before or after the meal.
The drug must be given directly into the mouth of the animal.

– Instructions for Modulis 100 mg/ml
Press and unscrew the vial cap while holding it down.
Insert the graduated syringe into the plastic adapter.
Hold the bottle upside down and slowly pull on the plunger of the syringe until the white line of the plunger matches the dose prescribed by your veterinarian. The syringe is graduated in kg and ml.
While pushing on the piston, empty the contents of the syringe directly in the jaws of the animal. Insert the syringe either on the side of the mouth or over the tongue.
If necessary, wipe the outside of the syringe with a dry tissue and dispose of it immediately after use. Close the vial and place the appropriate cap on the tip of the syringe to prevent contamination or overflow of remaining product.

– For 5 ml and 15 ml bottles
Volume to be administered with a 1 ml syringe: 0.05 ml / kg, ie 1 graduation / kg.

– For 15 and 30 ml bottles
Volume to be administered with a 2 ml syringe: 0.1 ml / 2 kg, ie 1 graduation / 2 kg.

Qualitative and quantitative composition Active ingredients and excipients with known effects:
One ml contains:
Active substance:
Ciclosporin ….. 100 mg
Excipient (s):
All-rac-alpha-tocopherol (E307) ….. 1 mg

Active principles / Molecule of Modulis 100 mg/ml:
Ciclosporin , pH , Active substance
Pharmaceutical form for Modulis 100 mg/ml:
Solution

Inscription on the table of poisonous substances (List I / II). Classification of the drug in dispensing:

List I of Modulis 100 mg/ml.
To be dispensed only on prescription.
Respect the prescribed doses.

Waiting time :
Not applicable.

Modulis 100 mg/ml

Properties 
Pharmacodynamic properties:
Cyclosporin (also known as cyclosporin, cyclosporine, cyclosporin A, CsA) is a selective immunosuppressant. It is an 11 amino acid cyclic polypeptide with a molecular weight of 1203 daltons which acts specifically and reversibly on T lymphocytes.

Cyclosporin has anti-inflammatory and antipruritic effects in the treatment of atopic dermatitis. It has been shown to act primarily by inhibiting T cell activation during antigenic stimulation by inhibiting the synthesis of IL-2 and other cytokines derived from T cells. Cyclosporin also has the ability to inhibit the function of presentation of the antigen in the cutaneous immune system. It also blocks the recruitment and activation of eosinophils, the production of cytokines by keratinocytes, the functions of Langerhans cells, the degranulation of mast cells and thus the release of histamine and pro-inflammatory cytokines. Always buy Modulis 100 mg/ml
Cyclosporine does not cause depressive effects on. It is very good for horses and camel dog cattle

Pharmacokinetic properties 
– Absorption for Modulis 100 mg/ml
The bioavailability of ciclosporin is approximately 35%. The peak plasma concentration is reached in 1 to 2 hours. Bioavailability is better and less subject to individual variation if administered on an empty stomach rather than at mealtime.

– Distribution 
In dogs , the volume of distribution of Modulis 100 mg/ml  is approximately 7.8 l / kg. Cyclosporin is widely distributed in all tissues. Following daily administration in dogs, the concentration of ciclosporin is much higher in the skin than in the blood.

– Metabolism 
Cyclosporin is mainly metabolized by cytochrome P450 (CYP 3A 4), both in the liver and in the intestine. The reactions of Modulis are essentially hydroxylations and demethylations that produce metabolites with little or no activity. Unchanged ciclosporin accounts for approximately 25% of circulating blood levels during the first 24 hours.

– Elimination l
The elimination is mainly by feces. Only 10% are eliminated by the urinary route, especially in the form of metabolites. .Modulis  is perfect for product for horses and camel.