registration support with GMP certificate
Aqueous solution for parenteral use.
Contains per ml. :
Tilmicosin base 300 mg.
Solvents ad. 1 ml.
Tilmicosin is a broad-spectrum semi-synthetic bactericidal macrolide antibiotic synthesized from tylosin. It has an antibacterial spectrum that is predominantly effective against Mycoplasma, Pasteurella and Haemophilus spp., and various Gram-positive organisms such as Staphylococcus spp. It is believed to affect bacterial protein synthesis. Cross-resistance between tilmicosin and other macrolide antibiotics has been observed. Following subcutaneous injection, tilmicosin is excreted mainly via the bile into the faeces, with a small proportion being excreted via the urine.
This solution is indicated for the treatment of respiratory infections in cattle and sheep associated with Mannheimia haemolytica, Pasteurella spp. and other tilmicosin-susceptible micro-organisms, and for the treatment of ovine mastitis associated with Staphylococcus aureus and Mycoplasma spp. Additional indications include the treatment of interdigital necrobacillosis in cattle (bovine pododermatitis, foul in the foot) and ovine footrot.
Hypersensitivity or resistance to tilmicosin.
Concurrent administration of other macrolides, lincosamides or ionophores.
Administration to equine, porcine or caprine species, to cattle producing milk for human consumption or to lambs weighing 15 kg or less.
Do not use in lactating animals. During pregnancy, use only after a risk/benefit assessment by a veterinarian. Do not use in heifers within 60 days of calving.
Do not use together with adrenalin or adrenergic antagonists such as propranolol.
Occasionally, a soft diffuse swelling may occur at the injection site which subsides without further treatment. The acute manifestations of multiple injections of large subcutaneous doses (150 mg/kg) in cattle included moderate electrocardiographic changes accompanied by mild focal myocardial necrosis, marked injection site oedema, and death. Single subcutaneous injections of 30 mg/kg in sheep produced increased respiration rate, and at higher levels (150 mg/kg) ataxia, lethargy and drooping of the head.
For subcutaneous injection:
Cattle pneumonia : 1 ml per 30 kg body weight (10 mg/kg).
Cattle interdigital necrobacillosis : 0.5 ml per 30 kg body weight (5 mg/kg).
Sheep pneumonia and mastitis : 1 ml per 30 kg body weight (10 mg/kg).
Sheep footrot : 0.5 ml per 30 kg body weight (5 mg/kg).
Note: Exercise extreme caution and take appropriate measures to avoid accidental self-injection, since injection of this drug in humans can be fatal! Macrotyl-300 should be administered only by a veterinary surgeon. Accurate weighing of animals is important to avoid overdosage. The diagnosis should be reconfirmed if no improvement is noted within 48 h. Administer once only.