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| Category | POM-V |
| Temperature | Ambient |
| MA/VM/EU No: | 42058/5021 |
| Species |
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| VMD Link | https://www.vmd.defra.gov.uk/productinformationdatabase/files/SPC_Documents/SPC_2087313.PDF |
| NOAH Link | |
| Dosage | Cattle A single subcutaneous injection of 2.5 mg tulathromycin/kg bodyweight (equivalent to 1 ml/40 kg body weight). For treatment of cattle over 300 kg bodyweight, divide the dose so that no more than 7.5 ml are injected at one site. Pigs A single intramuscular injection of 2.5 mg tulathromycin/kg bodyweight (equivalent to 1 ml/40 kg bodyweight) in the neck. For treatment of pigs over 80 kg bodyweight, divide the dose so that no more than 2 ml are injected at one site. For any respiratory disease, it is recommended to treat animals in the early stages of the disease and to evaluate the response to treatment within 48 hours after injection. If clinical signs of respiratory disease persist or increase, or if relapse occurs, treatment should be changed, using another antibiotic, and continued until clinical signs have resolved. Sheep A single intramuscular injection of 2.5 mg tulathromycin/kg bodyweight (equivalent to 1 ml/40 kg bodyweight) in the neck. To ensure correct dosage bodyweight should be determined as accurately as possible to avoid underdosing. For multiple vial entry, an aspirating needle or multi-dose syringe is recommended to avoid excessive broaching of the stopper. Contra-indications, warnings, etc Do not use in cases of hypersensitivity of the target animals to macrolide antibiotics. Do not use simultaneously with other macrolides or lincosamides. In the absence of compatibility studies, do not mix with other veterinary medicinal products. |
| Withdrawals | Withdrawal periods Cattle (meat and offal): 22 days Pig (meat and offal): 13 days Sheep (meat and offal): 16 days 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. Subcutaneous administration of Draxxin to cattle very commonly causes transient pain reactions and local swellings at the injection site that can persist for up to 30 days. No such reactions have been observed in pigs and sheep after intramuscular administration. Pathomorphological injection site reactions (including reversible changes of congestion, oedema, fibrosis and haemorrhage) are very common for approximately 30 days after injection in cattle and pigs. In sheep, transient signs of discomfort (head shaking, rubbing injection site, backing away) are very common after intramuscular injection. These signs resolve within a few minutes. If a hypersensitivity reaction occurs appropriate treatment should be administered without delay. The frequency of adverse reactions is defined using the following convention: -very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one treatment) -common (more than 1 but less than 10 animals in 100 animals) -uncommon (more than 1 but less than 10 animals in 1,000 animals) -rare (more than 1 but less than 10 animals in 10,000 animals) -very rare (less than 1 animal in 10,000 animals, including isolated reports). 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. Official, national and regional antimicrobial policies should be taken into account when the product is used. Cross resistance occurs with other macrolides. Laboratory studies in rats and rabbits have not produced any evidence of teratogenic, foetotoxic or maternotoxic effects. The safety of tulathromycin has not been established during pregnancy and lactation. Use only according to the benefit/risk assessment by the responsible veterinarian. In cattle at dosages of 3, 5 or 10 times the recommended dose, transient signs attributed to injection site discomfort were observed and included restlessness, head-shaking, pawing the ground, and brief decrease in feed intake. Mild myocardial degeneration has been observed in cattle receiving 5-6 times the recommended dose. In young pigs weighing approximately 10 kg given 3 or 5 times the therapeutic dose, transient signs attributed to injection site discomfort were observed and included excessive vocalisation and restlessness. Lameness was also observed when the hind leg was used as the injection site. In lambs (approx. 6 weeks old) at dosages of 3 or 5 times the recommended dose, transient signs attributed to injection site discomfort were observed, and included walking backwards, head shaking, rubbing the injection site, lying down and getting up, and bleating. The efficacy of antimicrobial treatment of foot rot in sheep might be reduced by others factors, such as wet environmental conditions, as well as inappropriate farm management. Treatment of foot rot should therefore be undertaken along with other flock management tools, for example providing dry environment. Antibiotic treatment of benign foot rot is not considered appropriate. Draxxin showed limited efficacy in sheep with severe clinical signs or chronic foot rot, and should therefore only be given at an early stage of foot rot. For the user Wash hands after use. Tulathromycin is irritating to eyes. In case of accidental eye exposure occurs, flush the eyes immediately with clean water. Tulathromycin may cause sensitisation by skin contact. In case of accidental spillage onto skin, wash the skin immediately with soap and water. In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician. |
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