TYLOPLUS INJ

COMPOSITION

Active substance:

Tilmicosin                           300 mg/ml

Excipients:

Propylene glycol (E1520)   250 mg/ml

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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.

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.

DOSAGE FOR EACH SPECIES, ROUTE AND METHOD OF ADMINISTRATION

For subcutaneous injection only.

Use 10 mg tilmicosin per kg body weight (corresponding to 1 ml Tyloplus Inj. 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 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.

ADVICE ON CORRECT ADMINISTRATION

Avoid introduction of contamination into vial during use. 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.

WITHDRAWAL PERIODS

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.

SPECIAL STORAGE PRECAUTIONS

Do not store above 25⁰C. Protect from direct sunlight. Do not refrigerate. Protect from frost.

SHELF-LIFE

Shelf-life of the veterinary medicinal product as packaged for sale: 2 years.

Shelf-life after first opening the immediate packaging: 28 days. 

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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 Staphyloccocus 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 in animals

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.

Special precautions to be taken by the person administering the medicinal products to animals

Operator Safety Warnings:

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Additional operator safety warnings:

• Avoid contact with skin and eyes. Rinse any splashes from skin or eyes immediately with water.

• May cause sensitisation by skin contact. Wash hands after use.

Use during pregnancy, lactation or lay

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.

Interaction with other medicinal products and other forms of interaction

Interactions between macrolides and ionophores could be observed in some species.

Overdose

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.

Incompatibilities

In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.

PACKAGE SIZES

Vials of 50 ml, 100 ml and 250 ml.