Category: C
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Category | POM-V |
Temperature | Ambient |
MA/VM/EU No: | 05653/4180 |
Species |
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VMD Link | https://www.vmd.defra.gov.uk/productinformationdatabase/files/SPC_Documents/SPC_564989.PDF |
NOAH Link | |
Dosage | Amounts to be administered and administration route For oral use. Before starting treatment, an evaluation of all alternative treatment options should be made. Dogs: The recommended dose of ciclosporin is 5 mg/kg body weight (0.05 ml of oral solution per kg BW) and should initially be administered daily. The frequency of administration should subsequently be reduced depending on the response. The product should initially be given daily until a satisfactory clinical improvement is seen. 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 dermatitis are satisfactorily controlled, the product can then be given every second day. 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 second day dosing, the veterinary surgeon can decide to give the product every 3 to 4 days. The lowest effective frequency of dosing should be used to maintain the remission of clinical signs. Patients should be regularly re-evaluated and alternative treatment options reviewed. Adjunct treatment (e.g. medicated shampoos, fatty acids) may be considered before reducing the dosing interval. The duration of treatment should be adjusted according to treatment response. 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. The recommended dose of ciclosporin is 5 mg/kg body weight (0.05 ml of oral solution per kg BW) and should initially be administered daily. The frequency of administration should subsequently be reduced depending on the response. The veterinary medicinal product should be given at least 2 hours before or after feeding. Insert the oral syringe directly into the dog’s mouth Dosages for dogs For the 5 and 15 ml vials (1 ml oral syringe graduated every 0.05 ml) (See Dosage Guide) At standard dosage of 5mg/kg Volume to be administered: 0.05 ml/kg Dosage guide: for Dogs (for the 5 & 15ml vials) Weight (kg) 2 3 4 5 6 7 8 9 10 Dose (ml) 0.1 0.15 0.2 0.25 0.3 0.35 0.4 0.45 0.5 Weight (kg) 11 12 13 14 15 16 17 18 19 20 Dose (ml) 0.55 0.6 0.65 0.7 0.75 0.8 0.85 0.9 0.95 1.0 wide table For the 30 and 50 ml vials (3 ml syringe graduated every 0.1 ml) (See dosage guide) At standard dosage of 5mg/kg Volume to be administered: 0.05ml/kg Dosage Guide: for Dogs (for the 30 & 50ml vials) Weight (kg) 2 4 6 8 10 12 14 16 18 20 Dose (ml) 0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 0.9 1.0 Weight (kg) 22 24 26 28 30 32 34 36 38 40 Dose (ml) 1.1 1.2 1.3 1.4 1.5 1.6 1.7 1.8 1.9 2.0 wide table Cats: The recommended dose of ciclosporin is 7 mg/kg body weight (0.07 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 product should initially be given daily until a satisfactory clinical improvement is seen (assessed by intensity of pruritus and lesion severity - excoriations, miliary dermatitis, eosinophilic plaques and/or self-induced alopecia). This will generally be the case within 4-8 weeks. Severe prolonged pruritus may induce a state of anxiety and subsequent excessive grooming behaviour. In such cases, despite an improvement in pruritus upon administration of the treatment, the resolution of self-induced alopecia may be delayed. Once the clinical signs of allergic dermatitis are satisfactorily controlled, the product can then be given every second day. In some cases where the clinical signs are controlled with every second day dosing, the veterinary surgeon can decide to give the product every 3 to 4 days. The lowest effective frequency of dosing should be used to maintain the remission of clinical signs. Patients should be regularly re-evaluated and alternative treatment options reviewed. The duration of treatment should be adjusted according to treatment response. 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. The product can be given either mixed with food or directly into the mouth. If given with food, the solution should be mixed with a small amount of food, preferably after a sufficient period of fasting to ensure complete consumption by the cat. Should the cat not accept the product mixed with food, it should be given by inserting the oral syringe directly into the cat’s mouth and delivering the entire dose. In case the cat only partially consumes the product mixed with food, administration of the product with the oral syringe should be resumed only the next day. Any uneaten medicated cat food must be disposed of immediately and the bowl washed thoroughly. The efficacy and tolerability of this product was demonstrated in clinical studies with a duration of 4.5 months. Dosage for cats: As the efficacy and safety of ciclosporin have not been assessed in cats weighing less than 2.3 kg (see "Special considerations for use") , administration of the product to cats weighing less than 2.3 kg should be according to a benefit-risk assessment by the responsible veterinarian. For the 5, 15 (1ml oral syringe graduated every 0.05ml), 30 and 50 ml vials (3 ml oral syringe graduated every 0.1 ml) At standard dosage of 7 mg/kg Volume to be administered: 0.07 ml/kg See dosage guide for cats Dosage guide: for cats Weight (kg) 2.1 2.9 3.6 4.3 5.0 5.7 6.4 7.1 7.9 Dose (ml) 0.15 0.2 0.25 0.3 0.35 0.4 0.45 0.5 0.55 Weight (kg) 8.6 9.3 10.0 10.7 11.4 12.1 12.8 13.6 14.3 Dose (ml) 0.6 0.65 0.7 0.75 0.8 0.85 0.9 0.95 1.0 wide table Overdose There is no specific antidote and in cases of signs of overdose the animal should be treated symptomatically. Dogs: No undesirable effects beyond those that were seen under recommended treatment have been observed in the dog with a single oral dose of up to 6 times what is recommended. In addition to what was seen under recommended dosage, the following adverse reactions were seen in case of overdose for 3 months or more at 4 times the mean recommended dosage: hyperkeratotic areas especially on the pinnae, callous-like lesions of the foot pads, weight loss or reduced weight gain, hypertrichosis, increased erythrocyte sedimentation rate, decreased eosinophil values. Frequency and severity of these signs are dose dependent.The signs are reversible within 2 months following cessation of treatment. Cats: The following adverse events were seen in the case of repeated administration for 56 days at 24 mg/kg (more than 3x the recommended dose) or for 6 months at up to 40 mg/kg (more than 5x the recommended dose): loose/soft faeces, vomiting, mild to moderate increases in absolute neutrophil counts, fibrinogen, activated partial thromboplastin time (APTT), slight increases in blood glucose and reversible gingival hypertrophy. Increased appetite was observed for both dose regimens. A transient increase followed by a decrease in lymphocyte counts was observed in treated cats, combined with a greater occurrence of palpable small peripheral lymph nodes. This may reflect immunosuppression following prolonged exposure to ciclosporin. APTT was prolonged in cats administered at least twice the recommended dose of ciclosporin. The frequency and severity of these signs were generally dose and time dependent. At 3x the recommended dose administered daily for nearly 6 months, changes in ECG (conduction disturbances) commonly occur. They are transient and not associated with clinical signs. Anorexia, recumbency, loss of skin elasticity, few or absent faeces, thin and closed eye lids may be observed in sporadic cases at 5x the recommended dose. |
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