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Category | POM-V |
Temperature | Ambient |
MA/VM/EU No: | 00879/4090 |
Species |
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VMD Link | https://www.vmd.defra.gov.uk/productinformationdatabase/files/SPC_Documents/SPC_328729.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. Cat: Bodyweight (kg) Dose (mls) 2 0.14 3 0.21 4 0.28 5 0.35 6 0.42 7 0.49 8 0.56 9 0.63 10 0.70 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 veterinary medicinal product should be administered in accordance with the following table: 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. 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 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 syringe should be resumed only the next day. The efficacy and tolerability of this product was demonstrated in clinical studies with a duration of 4.5 months. Dog: The mean recommended daily dose of ciclosporin is 5 mg/kg body weight (0.05 ml of oral solution per kg). The veterinary medicinal product should be administered in accordance with the following table: Bodyweight (kg) Dose (ml) Bodyweight (kg) Dose (ml) Bodyweight (kg) Dose (ml) 21 1.05 41 2.05 2 0.10 22 1.10 42 2.10 3 0.15 23 1.15 43 2.15 4 0.20 24 1.20 44 2.20 5 0.25 25 1.25 45 2.25 6 0.30 26 1.30 46 2.30 7 0.35 27 1.35 47 2.35 8 0.40 28 1.40 48 2.40 9 0.45 29 1.45 49 2.45 10 0.50 30 1.50 50 2.50 11 0.55 31 1.55 51 2.55 12 0.60 32 1.60 52 2.60 13 0.65 33 1.65 53 2.65 14 0.70 34 1.70 54 2.70 15 0.75 35 1.75 55 2.75 16 0.80 36 1.80 56 2.80 17 0.85 37 1.85 57 2.85 18 0.90 38 1.90 58 2.90 19 0.95 39 1.95 59 2.95 20 1.00 40 2.00 60 3.00 The veterinary medicinal product will initially be given daily until a satisfactory clinical improvement is seen. This will generally be the case within 4 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 veterinary medicinal product can then be given every other day as a maintenance dose. 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-other-day dosing, the veterinarian can decide to give the veterinary medicinal product every 3 to 4 days. Adjunct treatment (e.g. medicated shampoos, fatty acids) may be considered before reducing the dosing interval. 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 veterinary medicinal product should be given at least 2 hours before or after feeding. The product should be given by inserting the syringe directly into the dog’s mouth and delivering the entire dose. Overdose (symptoms, emergency procedures, antidotes), if necessary There is no specific antidote and in case of signs of overdose the animal should be treated symptomatically. Cat: 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 lymphocyte counts, fibrinogen, activated partial thromboplastin time (APTT), slight increases in blood glucose and reversible gingival hypertrophy. 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) may occur in very rare cases. 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. Dog: 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 of 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. |
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