Introduction
Company name: Elanco Animal Health
Address: Eli Lilly and Company Limited
Lilly House
Priestley Road, Basingstoke
Hampshire, RG24 9NL
Telephone: 01256 353131
Fax: 01256 779510
Email: elanco.uk.info@lilly.com
Website: www.elanco.com
Micotil
Introduction
Company name: Elanco Animal Health
Address: Eli Lilly and Company Limited
Lilly House
Priestley Road, Basingstoke
Hampshire, RG24 9NL
Telephone: 01256 353131
Fax: 01256 779510
Email: elanco.uk.info@lilly.com
Website: www.elanco.com
Presentation
Micotil is a sterile solution of the antibiotic tilmicosin for subcutaneous injection. Each ml contains 300 mg of tilmicosin activity; 25% w/v propylene glycol; phosphoric acid as needed to adjust pH; water for injection q.s. Tilmicosin is produced semi-synthetically and is a member of the macrolide class of antibiotics.
Uses
Micotil is indicated for the treatment of pneumonia in cattle and sheep, associated with Pasteurella haemolytica, Pasteurella multocida and other micro-organisms sensitive to tilmicosin, and for the treatment of ovine mastitis associated with Staphylococcus aureus and Mycoplasma agalactiae. For the treatment of interdigital necrobacillosis in cattle (bovine pododermatitis, foul in the foot) and ovine footrot.
Dosage and administration
Inject only subcutaneously in sheep over 15kg and young cattle. Administer a single subcutaneous injection of 0.5 or 1 ml Micotil per 30 kg bodyweight (equivalent to 5 or 10 mg tilmicosin per kg respectively)
Cattle
For pneumonia in cattle, use 10 mg/kg (1ml per 30kg bodyweight). For interdigital necrobacillosis in cattle, use 5 mg/kg (0.5ml per 30kg bodyweight)
Withdraw the required dose from the vial and remove the syringe from the needle. Insert a separate needle subcutaneously into the injection site and connect the syringe to it. Injection under the skin behind the shoulders and over the ribs is suggested. Do not inject more than 20 ml per injection site.
Sheep
For pneumonia and mastitis in sheep, use 10 mg/kg (1ml per 30kg bodyweight). For the treatment of footrot, use 5 mg/kg (0.5ml per 30kg bodyweight).
Withdraw the required dose from the vial and remove the syringe from the needle, leaving the needle in the vial. Restrain the sheep whilst leaning over the animal and insert a separate needle subcutaneously into the injection site which should be in a fold of skin over the rib cage behind the shoulder. Connect the syringe to the needle and inject into the base of the skin fold. Use the same draw-off needle for the whole group to be treated. Do not inject lambs weighing less than 15 kg, since there is a real risk of over dosage toxicity. Accurate weighing of lambs is important to avoid over dosage. The use of a 2 ml or smaller syringe will facilitate accurate dosing.
If no improvement is noted within 48 hours, the diagnosis should be confirmed.
Occasionally a soft diffuse oedematous swelling may occur at the injection site. The swelling disappears within five to eight days.
Contra-indications, warnings, etc
FOR ANIMAL TREATMENT ONLY
INJECTION OF THIS DRUG IN HUMANS CAN BE FATAL - EXERCISE EXTREME CAUTION TO AVOID ACCIDENTAL SELF-INJECTION AND FOLLOW THE ADMINISTRATION INSTRUCTIONS AND THE GUIDANCE BELOW, PRECISELY.
- This product should only be administered by a veterinary surgeon.
- Never carry a syringe loaded with Micotil with the needle attached. The needle should be connected to the syringe only when filling the syringe or administering the injection. Keep the syringe and the needle seperate at all times.
- Do not use automatic injection equipment.
- Ensure that animals are properly restrained, including those in the vicinity.
- Do not work alone using Micotil.
- In case of human injection, SEEK IMMEDIATE MEDICAL ATTENTION and take the vial or the package leaflet with you. Apply a cold pack (not ice directly) to the injection site.
NOTE TO PHYSICIAN
INJECTION OF THIS DRUG IN HUMANS HAS BEEN ASSOCIATED WITH FATALITIES
The cardiovascular system is the target of toxicity, and this toxicity may be due to calcium channel blockade. Administration of intravenous calcium chloride should only be considered if there is positive confirmation of exposure to tilmicosin.
In dog studies, tilmicosin induced a negative inotropic effect with consequent tachycardia, and a reduction in systemic arterial blood pressure and arterial pulse pressure.
DO NOT GIVE ADRENALINE OR BETA-ADRENERGIC ANTAGONISTS SUCH AS PROPRANOLOL
In pigs, tilmicosin-induced lethality is potentiated by adrenaline.
In dogs, treatment with intravenous calcium chloride showed a positive effect on the left ventricular inotropic state and some improvements in vascular blood pressure and tachycardia.
Pre-clinical data and an isolated clinical report suggest that calcium chloride infusion may help to reverse tilmicosin induced changes in blood pressure and heart rate in humans.
Administration of dobutamine should also be considered due to its positive inotropic effects although it does not influence tachycardia.
As tilmicosin persists in tissues for several days, the cardiovascular system should be closelt monitored and supportive treatment provided.
Physicians treating patients exposed to this compound are advised to discuss clinical management with the National Poisons Information Service on: 0870 600 6266
Keep out of the reach of children.
Avoid contact with eyes.
May cause sensitisation by skin contact.
Do not administer intravenously. Intravenous injection in cattle and sheep has been fatal.
Do not use in cows producing milk for human consumption.
Do not administer to horses, goats or pigs. Injection of the product in goats and pigs has been fatal.
Do not use in cattle producing milk for human consumption.
Do not use in heifers within 60 days of calving, nor in dry cows if the milk is intended for human consumption.
Withdrawal period
Cattle must not be slaughtered for human consumption for at least 60 days after treatment.
Sheep must not be slaughtered for human consumption for at least 42 days after treatment.
Ewe's milk must not be used for human consumption for at least 15 days after treatment.
Pharmaceutical precautions
Do not store above 30°C. Protect from direct sunlight.
Following withdrawal of the first dose, use the product within 90 days. Discard unused material. Avoid introduction of contamination into bottle during use. Should any growth or discoloration occur the product should be discarded.
Dispose of unused product and containers in accordance with guidance from your local waste regulation authority.
Expiry date is two years from the date of manufacture. For shelf-life see expiry date on label.
Legal category
POM-V
Packaging Quantities
Multi-dose amber vials containing 25 ml, 50 ml and 100 ml.
Further information
Micotil is effective as a single subcutaneous injection. Lung concentrations of tilmicosin following injection are significantly higher than serum levels. In calves, lung concentrations of tilmicosin remained above the tilmicosin MIC90 of 3.12 μg/ml for Pasteurella haemolytica for approximately 4 days following the single subcutaneous injection of Micotil 300 at the recommended dose.
Marketing authorisation number
Vm 00006/4093.