CYCLAVANCE 30ML

Ciclosporin 100 mg/ml. Treatment of clinical manifestations of dermatitis.
atopic in dogs, in oral solution.

The clinical symptoms of the
Atopic dermatitis, such as itching and skin inflammation, are not specific to
this disease. Other causes of dermatitis such as infestations by
ectoparasites, other allergies that cause dermatological symptoms (eg.
flea allergy dermatitis or food allergy) or bacterial infections and
Fungal infections should be ruled out before starting treatment. It is a good idea
practice treating flea infestations before and during treatment
atopic dermatitis.

PHARMACEUTICAL FORM CYCLAVANCE Oral solution.

COMPOSITION PER ML Ciclosporin 100 mg/ml.

INTERACTIONS AND
INCOMPATIBILITIES,* Compounds of the azole group (e.g.

ketoconazole) increase the concentration of cyclosporine in the blood. Ketoconazole
at 5-10 mg/kg increases the concentration of cyclosporine in blood up to 5 times.
Macrolides such as erythromycin can double the levels.
plasma cyclosporine. Certain inducers such as cytochrome P450,
antiepileptics and antibiotics (e.g.

trimethoprim/sulfonamide) can
reduce the plasma concentration of cyclosporine. The administration
simultaneous with P-glycoprotein substrates (such as macrocyclic lactones
ivermectin and milbemycin) could reduce the outflow of these substances
active giving signs of toxicity to the CNS.

* Cyclosporine may
increase the nephrotoxicity of aminoglycoside antibiotics and
trimethoprim, so its concomitant use is not recommended.

INDICATIONS AND TARGET SPECIES, Dogs Treatment of manifestations
atopic dermatitis clinics.

CONTRAINDICATIONS,* Hypersensitivity
to the active substance or any of its components.

* Less dogs
6 months of age or less than 2 kg in weight.

* Malignant disorders
historical or progressive malignant disorders, nor in animals with diabetes.

* Do not vaccinate with live vaccines during treatment or for 2 weeks after
interval after or before treatment.

SIDE EFFECTS,*
Gastrointestinal disorders such as vomiting, loose stools, mucous membranes, and diarrhea.
These reactions are mild and transient and do not require discontinuation of the
treatment.

* Less frequently Lethargy or hyperactivity, anorexia,
Mild to moderate gingival hyperplasia, skin reactions, lesions
verruciform, changes in fur, redness or swelling of the pinna
ear, weakness or muscle cramps. * Transient moderate salivation.

* In very rare cases diabetes mellitus especially in West Highland
White Terrier.

ROUTE OF ADMINISTRATION Oral.

DOSAGE, Dogs 5
mg/kg bw (0,05 ml of oral solution per kg bw) 2 hours before or after
meals by inserting the dosing syringe into the animal's mouth.

Administer daily initially until clinical improvement is achieved.
satisfactory (4-8 weeks). If there is no improvement in 8 weeks, stop the
treatment. If symptoms are satisfactorily controlled, administer every 2
days and perform clinical controls to adjust the frequency.

SPECIAL PRECAUTIONS,* In laboratory animals at high doses it is
embryotoxic and fetotoxic. In breeders and pregnant women, assess the benefit/risk.

* With kidney disease monitor creatinine.

MODE OF
STORAGE Do not refrigerate. Once opened, do not store above 25°C.

OBSERVATIONS Medication subject to veterinary prescription.

PRESENTATION 5, 15, 30 or 50 ml with dispensing cap and graduated syringe.