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ΠΑΡΑΡΤΗΜΑ 1: ΠΕΡΙΛΗΨΗ ΤΩΝ ΧΑΡΑΚΤΗΡΙΣΤΙΚΩΝ ΤΟΥ ΠΡΟΪΟΝΤΟΣ 1. NAME OF VETERINARY MEDICINAL PRODUCT COLINDOX 100, 100mg/g - premix for medicated feed for swine 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 g product contains: Active ingredient: tiamuline 100 mg (from tiamulin hydrogen fumarate 125 mg) Eccipients: colouring agent E122 2 mg For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Premix for medicated feed 4. CLINICAL INFORMATION 4.1 Target species Swine 4.2 Indications for use, specifying the target species Mycoplasmosis, enzoothic pneumonia (M. hyopneumoniae, M. hyorhinis, P. multocida, Haemophilus spp., Actynomyces pyogenes, Staphylocccus spp. And Streptococcus spp), and superficial necrotic enteritis (Brachyspira hyodysenteriae) caused by tiamulin-susceptible bacteria. 4.3 Contraindications Do not use in case of hypersensitivity to active substance or to any of the excipients. 4.4 Special warnings for each target species The intake of the drug by the animals may be altered according to the type and severity of the disease. Animals which show a reduced appetite for feed should be treated through the parental route, with an injectable product prescribed by the veterinarian. Repeated or prolonged use of the product has to be avoided, by increasing the hygiene management through cleaning and disinfection. 4.5 Special precautions for use Special precautions for use in animals: If it’s possible, tiamulin has to be used after the indication of antibiograms. Any use of the product different to what is included in the Summary of the Product Characteristics, could lead to the prevalence of bacteria resistant to tiamulin. 1/5 Special precautions to be taken by the person administering the veterinary medicinal product to animals The product has a controlled emission factor with reduction of the dust exposure risks; it’s suggested to avoid direct contact. Handling the product wearing protective clothes, gloves and mask; do not inhale. Avoid the contact with skin and eyes. Rinse thoroughly with water and soap in case of accidental contact with eyes or skin. Do not eat, drink or smoke during handling; wash hands after use. Persons with known hypersensitivity to the active substance should avoid contact with the veterinary medicinal product. 4.6 Adverse reactions (frequency and seriousness) There could be possible alteration of the bacterial intestinal flora, diarrhoea and soft faeces. Rare cases of hypersensitive to tiamulin may occur with acute dermatitis, cutaneous erythemas and intense itching. If these undesired effects appear, immediately stop the treatment and consult the veterinarian. If any very severe adverse reactions or other reaction not mentioned in this SPC occur, please inform the veterinarian. 4.7 Use during pregnancy, lactation or lay During pregnancy and during lactation, use only accordingly to the benefit/risk assessment by the responsible veterinarian. 4.8 Interaction with other medicinal products and other forms of interaction. The concomitant administration of ionophores (monensin, nararasin, salinomycin) and tiamulin, causes in swine toxic phenomena accompanied by anatomohistopathology alterations. Therefore in swine feed do not administer ionophore products with tiamulin treatments unless the ionophores will be added to the swine feed at least 7 days after or before the treatment, otherwise severe nanism or death can occur. Tiamulin can reduce the antibacterial activity of beta-lactamic antibiotics whose the efficacy depends of the bacterial multiplication. Rarely, in swine tiamulin can cause hypersensitivity reactions when administrated with feed contaminated by mycotoxins. 4.9 Amount to be administrated and administration route The medicinal product has to be administrated accurately mixed in feed at the dosage of 1.25 – 2 g/kg of feed (equivalent to 125 - 200 mg tiamulin/kg of feed), corresponding to 4-10 mg of active substance/kg b.w., for 3-5 days. To ensure the administration of a correct dosage of the medicinal product, the animal body weight has to be accurately evaluated to avoid any subdosage. Use calibrated means to achieve the right dosage. 2/5 4.10 4.11 Overdose (symptoms, emergency procedures, antidotes), if n necessary Data not available. Do not exceed the recommended doses. Withdrawal period(s) Meat and offals: 10 days 5. PHARMACOLOGICAL PROPERTIES Pharmacotherapeutic Group:systemic antibiotics - pleuromutiline ATCvet Code: QJ01XQ01 5.1 Pharmacodynamic properties Tiamulin is an semi-synthetic antibiotic from the pleuromuline class with bacteriostatic activity. Mechanism of action: inhibition of the bacterial protein synthesis by link to bacterial ribosomal subunit 50S. Tiamulin shows an in vitro efficacy against a wide range of pathogenic microorganism, such us: Mycoplasmas M. gallisepticum MIC 0.05-0.1 µg/ml, M. hyopneumoniae MIC 0.03-0.06 µg/ml, M. hyorhinis MIC 0.2-0.78 µg/ml, M. hyosinoviae MIC 0.013-0.1 µg/ml, M. synoviae MIC 0.05-0.1 µg/ml; Gram-positive Clostridium perfringens MIC 0.39-0.78 µg/ml, Erysipelotrix spp. MIC 2.5-3.12 µg/ml, Listeria monocytogenes MIC 3.12-5 µg/ml, Staphylococcus spp. MIC 0.5-2 µg/ml, Streptococcus spp. MIC 0.039-0.062 µg/ml); Gram-negative A.pleuropneumoniae MIC 8-32 µg/ml, Brachyspira hyodysenteriae MIC 0.016-32 µg/ml, Klebsiella pneumoniae MIC 0.062-2.5 µg/ml, Lawsonia intracellularis MIC 4 µg/ml, Leptospira spp. MIC 0.07-2.5 µg/ml. 5.2 Pharmacokinetic particulars After oral administration, tiamulin is absorbed very quickly and almost completely (about 90% of the administered dose); serum peak is achieved in 2 to 6 hours. Once absorbed, the drug distributes in all tissues, with the highest concentration at lungs level; the metabolytes are bacteriologically inactive, and excreted mostly through the bile and less through the urine. After the administration of a single dose of 10 mg or 25 mg of a.s. tiamulin/Kg b.w., the obsverved Cmax values, microbiologically evaluated, were 1.03 μg/ml and 1.82 μg/ml respectvely, and the Tmax was achieved in 2 hours for both dosages. 3/5 The observed AUC after administration of 10 mg active substance/Kg b.w., by gavage or through medicated feed (180 ppm), was respectively of 0.88 and 2.5 μg.h/ml. 6. PHARMACEUTICAL PARTICULARS 6.1 List of excipients Vaseline oil. Sorbitole 70%. Colouring agent E122. Hazel nut fibre. 6.2 Incompatibilities In absence of compatibility studies, do not mix with other veterinary drugs. 6.3 Shelf life Shelf life of the veterinary medicinal product packaged for sale: 24 months. Shelf life after first opening of the immediate packaging: 30 days Shelf life after incorporation into meal or pelleted feed: 60 days 6.4 Special precautions for storage This veterinary medicinal product does not require any special temperature storage conditions. After each use, keep the container tighly closed to protect the medicinal product from light and humidity. 6.5 Nature and composition of immediate packaging Multilayer paper bag, internally aluminated, containing 20Kg of product. 6.6 Special precautions for the disposal of the unused veterinary medicinal product or waste materials from the use of such products Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements. 7. Marketing Authorisation Holder DOX-AL ITALIA SPA Largo Donegani 2 -20121 Milano 8. Μarketing authorisation number CY00079V 4/5 9. Date of first Authorisation/Renewal of the authorization 30/4/2004,16/7/2015 10. Date of revision of the text 16/7/2015 Mode of use To be sold and used only upon veterinary prescription 5/5