Sporimune 50 mg/ml Oral Solution 50ml

Target species Dog, cat. 4.2 Indications for use, specifying the target species Treatment of chronic manifestations of atopic dermatitis in dogs. Symptomatic treatment of chronic allergic dermatitis in cats. 4.3 Contraindications Do not use in cases of hypersensitivity to the active substance or any of the excipients. Do not use in dogs less than six months of age or less than 2 kg in weight. Do not use in cases with a history of malignant disorders or progressive malignant disorders. Do not vaccinate with a live vaccine during treatment or within a two-week interval before or after treatment. (see also sections 4.5 “Special precautions for use” and 4.8 “Interaction with other medicinal products”). Do not use in cats infected with FeLV or FIV. 4.4 Special warnings for each target species Consideration should be given to the use of other measures and/or treatments to control moderate to severe pruritus when initiating therapy with ciclosporin. 4.5 Special precautions for use Special precautions for use in animals Clinical signs of atopic dermatitis in dogs and allergic dermatitis in cats such as pruritus and skin inflammation are not specific for this disease. Therefore other causes of dermatitis such as ectoparasitic infestations, other allergies which cause dermatological signs (e.g. flea allergic dermatitis or food allergy) or bacterial and fungal infections should be evaluated and eliminated where possible. It is good practice to treat flea infestations before and during treatment of atopic and allergic dermatitis. A complete clinical examination should be performed before treatment. Any infections should be properly treated before initiation of treatment. Infections occurring during treatment are not necessarily a reason for drug withdrawal, unless the infection is severe. Particular attention must be paid to vaccination. Treatment with the veterinary medicinal product may interfere with vaccination efficacy. In the case of inactivated vaccines, it is not recommended to vaccinate during treatment or within a two-week interval before or after administration of the product. For live vaccines see also section 4.3 “Contraindications”. It is not recommended to use other immunosuppressive agents concomitantly. In laboratory animals, ciclosporin is liable to affect the circulating levels of insulin and to cause an increase in glycaemia. In the presence of suggestive signs of diabetes mellitus, the effect of treatment on glycaemia must be monitored. If signs of diabetes mellitus are observed following the use of the product, e.g. polyuria or polydipsia, the dose should be tapered or discontinued and veterinary care sought. The use of ciclosporin is not recommended in diabetic animals While ciclosporin does not induce tumours, it does inhibit T-lymphocytes and therefore treatment with ciclosporin may lead to an increased incidence of clinically apparent malignancy due to the decrease in antitumour immune response. The potentially increased risk of tumour progression must be weighed against the clinical benefit. If lymphadenopathy is observed in animals being treated with ciclosporin, further clinical investigations are recommended and treatment discontinued if necessary. Dogs Closely monitor creatinine levels in dogs with severe renal insufficiency. Cats Allergic dermatitis in cats can have various manifestations, including eosinophilic plaques, head and neck excoriation, symmetrical alopecia and/or miliary dermatitis. The immune status of the cats to FeLV and FIV infections should be assessed before treatment. Cats that are seronegative for T. gondii may be at risk of developing clinical toxoplasmosis if they become infected while under treatment. In rare cases this can be fatal. Potential exposure of seronegative cats or cats suspected to be seronegative to Toxoplasma should therefore be minimised (e.g. keep indoors, avoid raw meat or scavenging). Ciclosporin was shown to not increase T. gondii oocyte shedding in a controlled laboratory study. In cases of clinical toxoplasmosis or other serious systemic illness, stop treatment with ciclosporin and initiate appropriate therapy. Clinical studies in cats have shown that decreased appetite and weight loss may occur during ciclosporin treatment. Monitoring of body weight is recommended. Significant reduction in body weight may result in hepatic lipidosis. If persistent, progressive weight loss occurs during treatment it is recommended to discontinue treatment until the cause has been identified. The efficacy and safety of ciclosporin has neither been assessed in cats less than 6 months of age nor weighing less than 2.3 kg. Special precautions to be taken by the person administering the veterinary medicinal product to animals Accidental ingestion of this product may lead to nausea and/or vomiting. To avoid accidental ingestion, the product must be used and kept out of reach of children. Do not leave unattended filled syringe in the presence of children. Any uneaten medicated cat food must be disposed of immediately and the bowl washed thoroughly. In case of accidental ingestion, particularly by a child, seek medical advice immediately and show the package leaflet or the label to the physician. Ciclosporin can trigger hypersensitivity (allergic) reactions. People with known hypersensitivity to ciclosporin should avoid contact with the product. Irritation to eyes is unlikely. As precautionary measure avoid contact with eyes. In case of contact, rinse thoroughly with clean water. Wash hands and any exposed skin after use 4.6 Adverse reactions (frequency and seriousness) Dogs Gastrointestinal disturbances such as vomiting, mucoid or soft faeces and diarrhoea are observed very commonly. They are mild and transient and generally do not require the cessation of the treatment. Other undesirable effects may be observed uncommonly: lethargy or hyperactivity, anorexia, mild to moderate gingival hyperplasia, skin lesions such as verruciform lesions or change of hair coat, red and swollen pinnae, muscle weakness or muscle cramps. These effects generally resolve spontaneously after treatment is stopped. In very rare cases diabetes mellitus has been observed, reported mainly in West Highland White Terriers. As for the subject of malignancy, please see sections 4.3 “Contraindications” and 4.5 “Special precautions for use”. Cats In 2 clinical studies with 98 cats treated with ciclosporin the following undesirable effects were observed: Very common: gastrointestinal disturbances such as vomiting and diarrhoea. These are generally mild and transient and do not require the cessation of the treatment. Common: lethargy, anorexia, hypersalivation, weight loss and lymphopenia. These effects generally resolve spontaneously after treatment is stopped or following a decrease in the dosing frequency. As for the subject of malignancy, please see sections 4.3 “Contraindications” and 4.5 “Special precautions for use”. Side effects may be severe in individual animals. The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports). 4.7 Use during pregnancy, lactation or lay In laboratory animals, at doses which induce maternal toxicity (rats at 30 mg/kg bw and rabbits at 100 mg/kg bw) ciclosporin was embryo- and foetotoxic, as indicated by increased pre- and postnatal mortality and reduced foetal weight together with skeletal retardations. In the well-tolerated dose range (rats at up to 17 mg/kg bw and rabbits at up to 30 mg/kg bw) ciclosporin was without embryolethal or teratogenic effects. The safety of the drug has neither been studied in breeding male cats or dogs nor in pregnant or lactating female cats or dogs. In the absence of such studies in the target species, it is recommended to use the drug in breeding cats or dogs only upon a positive risk/benefit assessment by the veterinarian. Ciclosporin passes the placenta barrier and is excreted via milk. Therefore the treatment of lactating bitches or queens is not recommended. 4.8 Interaction with other medicinal products and other forms of interaction Various substances are known to competitively inhibit or induce the enzymes involved in the metabolism of ciclosporin, in particular cytochrome P450 (CYP 3A 4). In certain clinically justified cases, an adjustment of the dosage of the veterinary medicinal product may be required. Ketoconazole is known to increase the blood concentration of ciclosporin in cats and dogs which is considered to be clinically relevant. During concomitant use of ketoconazole and ciclosporin the veterinarian should consider as a practical measure to double the treatment interval if the animal is on a daily treatment regime. Macrolides such as erythromycin may increase the plasma levels of ciclosporin up to twofold. Certain inducers of cytochrome P450, anticonvulsants and antibiotics (e.g. trimethoprim/sulfadimidine) may lower the plasma concentration of ciclosporin. Ciclosporin is a substrate and an inhibitor of the MDR1 P-glycoprotein transporter. Therefore, the co-administration of ciclosporin with P-glycoprotein substrates such as macrocyclic lactones (e.g. ivermectin and milbemycin) could decrease the efflux of such drugs from blood-brain barrier cells, potentially resulting in signs of CNS toxicity. In clinical studies with cats treated with ciclosporin and selamectin or milbemycin, there did not appear to be an association between these drugs’ concomitant use and neurotoxicity. Ciclosporin can increase the nephrotoxicity of aminoglycoside antibiotics and trimethoprim. The concomitant use of ciclosporin is not recommended with these active ingredients. Particular attention must be paid to vaccination (see sections 4.3 “Contraindications” and 4.5 “Special precautions for use”). Concomitant use of immunosuppressive agents: see section 4.5 “Special precautions for use”.