Maa: Israel
Kieli: englanti
Lähde: Ministry of Health
TULATHROMYCIN
ZOETIS ISRAEL HOLDING B.V., ISRAEL
SOLUTION FOR INJECTION
TULATHROMYCIN 100 MG / 1 ML
I.M, S.C
Required
ZOETIS MANUFACTURING & RESEARCH SPAIN, S.L
Cattle : treatment and prevention of bovine respiratory disease associated with mannheimia ( pasteurella) haemolytica pasteurella multocida haemophilus somnus and mycoplasma bovis sensitive to tulathromycin. The presence of the disease in the herd should be established before preventative treatment. Pigs : treatment of swine respiratory disease associated with actinobacillus pleuropneumoniae pasteurella multocida and mycoplasma hyopneumoniae sensitive to tulathromycin.
2019-03-31
• Overdose In cattle, in administration of 3, 5 or 10 times the recommended dose, transient signs attributed to injection site discomfort were observed and included restlessness, headshaking, pawing the ground, and brief decrease in feed intake. Mild myocardial degeneration has been observed in cattle receiving 5-6 times the recommended dosage. In young pigs weighing approximately 10 kg given 3 or 5 times the therapeutic dose transient signs attributed to injection site discomfort were observed, including excessive vocalisation and restlessness. Lameness was observed when the hind leg was used as the injection site. • Incompatibility Given that compatibility studies have not been conducted, do not mix Draxxin with other veterinary medicinal products. 11. STORAGE INSTRUCTIONS Prevent poisoning! To prevent poisoning, keep this, and all other medicines, in a closed place, out of the reach and sight of children and/or infants. Do not use the medicine after the expiry date (exp. date) which is stated on the package. The expiry date refers to the last day of that month. • Storage conditions Store below 30°C • Shelf-life after opening the bottle 28 days. 12. INSTRUCTIONS FOR THE DISPOSAL OF THE UNUSED PRODUCT OR WASTE MATERIALS Dispose of any remaining veterinary medicine or waste obtained from using a veterinary medicine in the same manner as toxic waste; do not discard into a sewer. 13. ADDITIONAL INFORMATION • IN ADDITION TO THE ACTIVE INGREDIENT, THIS MEDICINE ALSO CONTAINS Citric Acid, anhydrous Hydrochloric Acid (for pH adjustment) Sodium Hydroxide (for pH adjustment) Propylene Glycol Monothioglycerol Water for Injections • WHAT THE MEDICINE LOOKS LIKE AND CONTENTS OF THE PACK A vial with a clear, colourless to yellowish solution. • PACK SIZES Glass vial with volume of 20, 50, 100, 250 and 500 ml. Not all volumes may be marketed. The 500 ml vials must not be used for pigs. • REGISTRATION HOLDER Zoetis Israel Holding B.V., 5 Atir Yeda Street, Kfar Saba • MANUFACTURER’S NAME FAREVA AMBOISE, FRAN Lue koko asiakirja
Draxxin LPD 05.10.2021 1 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Draxxin Injectable Solution Veterinary 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCE: Tulathromycin 100 mg/ml EXCIPIENT: Monothioglycerol 5 mg/ml For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. Clear colourless to slightly yellow solution. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle, pigs 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Cattle Treatment and prevention of bovine respiratory disease associated with mannheimia (pasteurella) haemolytica pasteurella multocida haemophilus somnus and mycoplasma bovis sensitive to tulathromycin. The presence of the disease in the herd should be established before preventative treatment. Pigs Treatment of swine respiratory disease associated with actinobacillus pleuropneumoniae pasteurella multocida and mycoplasma hyopneumoniae sensitive to tulathromycin. 4.3 CONTRAINDICATIONS Do not use in case of hypersensitivity of the target animals to macrolide antibiotics. Do not use simultaneously with other macrolides or lincosamides (see section 4.8). Do not use in lactating animals producing milk for human consumption. Do not use in pregnant animals, which are intended to produce milk for human consumption, within 2 months of expected parturition. Draxxin LPD 05.10.2021 2 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals Use of the product should be based on susceptibility testing of the bacteria isolated from the animal. If this is not possible, therapy should be based on local (regional, farm level) epidemiological information about susceptibility of the target bacteria. If a hypersensitivity reaction occurs appropriate treatment should be administered without delay. Special precautions to be taken by the person administering the veterinary medicinal product to animals Tulathromycin is irritating to eyes. In case of accidental eye exposure, flush the eyes immediate Lue koko asiakirja