Tilmicodem Injectable 300 mg/ml

Injectable Solution

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1. NAME AND ADRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER, IF DIFFERENT
Delos Impex ’96 S.R.L.
81, Horia, Closca si Crisan Street,
Otopeni, Ilfov District, Romania
Tel. +0040-372 714 433 Fax: +0040-0372 871 445

2. NAME OF THE VETERINARY MEDICINAL PRODUCT
Tilmicodem 300 mg/ml, solution for injection for cattle and sheep.

3. STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTS
1 ml solution contains:
Active substance:
Tilmicosin 300 mg

4. INDICATIONS
Cattle
Treatment of bovine respiratory disease associated with Mannheimia haemolytica and Pasteurella multocida.
Treatment of interdigital necrobacillosis.
Sheep
Treatment of respiratory tract infections caused by Mannheimia haemolytica and Pasteurella multocida.
Treatment of foot rot in sheep caused by Dichelobacter nodosus and Fusobacterium necrophorum.
Treatment of acute ovine mastitis caused by Staphylococcus aureus and Mycoplasma agalactiae.

5. CONTRAINDICATIONS
Do not administer intravenously.
Do not administer intramuscularly
Do not administer to lambs weighing less than 15 kg.
Do not administer to primates.
Do not administer to pigs.
Do not administer to horses and donkeys.
Do not administer to goats.
Do not use in case of hypersensitivity to the active substance or to any of the excipients.

6. ADVERSE REACTIONS
Occasionally, a soft diffuse swelling may occur at the injection site but this disappears within five to eight days. In rare cases recumbency, incoordination and convulsions have been observed.
Deaths of cattle have been observed following a single intravenous dose of 5 mg/kg body weight, and following the subcutaneous injection of doses of 150 mg/kg body weight at 72 hour intervals. In pigs, intramuscular injection at 20 mg/kg body weight has caused deaths. Sheep have died following a single intravenous injection of 7.5 mg/kg body weight.

7. TARGET SPECIES
Cattle and sheep.

8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
FOR SUBCUTANEOUS INJECTION ONLY
Use 10 mg tilmicosin per kg body weight (corresponding to 1 ml Tilmicodem per 30 kg body weight).

Cattle:
Method of administration:
Withdraw the required dose from the vial and remove the syringe from the needle, leaving the needle in the vial. When a group of animals has to be treated, leave the needle in the vial to remove the subsequent doses. Restrain the animal and insert a separate needle subcutaneously at the injection site, preferably in a skinfold over the rib cage behind the shoulder. Attach the syringe to the needle and inject into the base of the skinfold. Do not inject more than 20 ml per injection site.

Sheep:
Method of administration:
Accurate weighing of lambs is important to avoid overdosing. The use of a 2 ml syringe or smaller improves accurate dosing.
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 skinfold over the rib cage behind the shoulder. Attach the syringe to the needle and inject into the base of the skin fold. Do not inject more than 2 ml per injection site.

9. ADVICE ON CORRECT ADMINISTRATION
Official, national and regional antimicrobial policies should be taken into account when the product is used.
To avoid self-injection do not use automatic injection equipment.
The vial should be inspected visually for any foreign particulate matter and/or abnormal physical appearance. In the event of either being observed, discard the vial.

10. WITHDRAWAL PERIOD
Cattle:
Meat and offal: 70 days
Milk: 36 days
If the product is administered to cows during the dry period or to pregnant dairy heifers, milk should not be used for human consumption until 36 days after calving.

Sheep:
Meat and offal; 42 days
Milk: 18 days
If the product is administered to ewes during the dry period or to pregnant ewes, milk should not be used for human consumption until 18 days after lambing.

11. SPECIAL PRECAUTIONS FOR STORAGE
Keep away from reach and sight of children!
Shelf-life after first opening of package: 28 days. Close tight the recipient after use.
Do not use after expiry date which is stated on the label.
Protect from direct sunlight.

12. SPECIAL WARNINGS
Special warnings for each target species
Sheep
The clinical trials did not demonstrate a bacteriological cure in sheep with acute mastitis caused by Staphylococcus aureus and Mycoplasma agalactiae.
Do not administer to lambs weighing less than 15 kg since there is a risk of overdose toxicity. Accurate weighing of lambs is important to avoid overdose. The use of a 2 ml or smaller syringe will facilitate accurate dosing.
Special precautions for use
Official, national and regional antimicrobial policies should be taken into account when the product is used.
To avoid self-injection do not use automatic injection equipment.
Wherever possible, the use of the product should be based on susceptibility testing.

Operator Safety Warnings:

INJECTION OF TILMICOSIN 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 Tilmicodem 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 needle separate at all other times.
Do not use automatic injection equipment.
Ensure that animals are properly restrained, including those in the vicinity.
Do not work alone when using Tilmicodem.
In case of self-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.

Additional operator safety warnings:
Avoid contact with skin and eyes. Rinse any splashes from skin and eyes immediately with water.
May cause sensitisation by skin contact. Wash hands after use.

NOTE TO THE PHYSICIAN
INJECTION OF TILMICOSIN 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 ADRENALIN OR BETA-ADRENERGIC ANTAGONISTS SUCH AS PROPRANOLOL.
In pigs, tilmicosin-induced lethality is potentiated by adrenalin.
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 closely monitored and supportive treatment provided.
Physicians treating patients exposed to this compound are advised to discuss clinical management with the National Poison Information Service on: 0844 8920111

The safety of the veterinary medicinal product has not been established during pregnancy.
Use only according to the benefit/risk assessment by the responsible veterinarian.
Interactions between macrolides and ionophores could be observed in some species.
In cattle subcutaneous injections of 10, 30 and 50 mg/kg body weight, repeated three times with a 72 hours interval, did not cause death. As expected, oedema developed at the site of injection. The only lesion observed at autopsy was a necrosis of the myocardium in the group treated with 50 mg/kg body weight.
Doses of 150 mg/kg body weight, administered subcutaneously with an interval of 72 hours caused death. Oedema at the site of injection was observed and at autopsy a light necrosis of the myocardium was the only lesion determined. Other symptoms observed were: difficulty in moving, reduced appetite and tachycardia.
In sheep single injections (approximately 30 mg/kg body weight) may cause a slight increase of the rate of respiration. Higher doses (150 mg/kg body weight) caused ataxia, lethargy and the inability to raise the head.
Deaths occurred after one single intravenous injection of 5 mg/kg body weight in cattle and 7.5 mg/kg in sheep body weight.
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.

13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS
For the environmental protection, medicines should not be disposed of via wastewater or household waste. Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with national requirements.

14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED

15. OTHER INFORMATION
100 ml or 250 ml polypropylene vials sealed with a rubber stopper and aluminium overseal. Each vial is packed into a carton.
Not all pack sizes may be marketed.
For any information regarding this veterinary medicinal product, please contact the local representative of the marketing authorization holder.
Delos Impex ’96 S.R.L.
81, Horia, Closca si Crisan Street,
Otopeni, Ilfov District, Romania
Tel. +40-372 714 433 Fax: +40-0372 871 445