NAM PHUC THINH TRADING CO., LTD

TILOSINA 20% LIQUIDA TREI  

Compositions:
1 g contains: Tylosin tartrate equal to tylosin base 200 mg; Excipients: sodium methyl-p-hydroxybenzoate, sodium propyl-p-hydroxybenzoate and other q.s. to 1 g  

Pharmaceutical form: Oral solution                                                                          

Target species: Milking calves, broiler chickens and pigs.

Indications: 

Milking calves: pneumonia caused by mycoplasm and/or pasteurella multocida.

Brolier chickens: chronic respiratory disease sustained by pathogens sensitive to tylosin.

Pigs: enzootic pneumonia and necrotic enteritis caused by pathogens sensitive to tylosin.

Contraindications:  Do not use in animals that are known to be hypersensitive to tylosin or to any of the excipients. Do not use the product simultaneously with other macrolides or lincosamides. Do not use in animals known to display resistance to tylosin or cross-resistance to other macrolides. Do not use in animals
with liver failure. Do not administer to broilers that lay eggs for human consumption.

Side effects: Cases of edema to the rectal mucous gland with itching and erythema have been reported, especially in pigs. If severe reactions occur or other reactions not mentioned on the label, please inform the
veterinarian.

Dosage, route and method of administration: The product must be administered diluted in drinking water
or liquid feed, following the instructions of the prescribing Veterinarian, being careful not to exceed the
authorised daily dosage in mg/Kg b.w. Do not mix in solid feed.

Milking calves: from 0.2 to 0.25 g of product/kg b.w. equal to 40-50 mg/kg b.w. of tylosin for 3-7 days.
Broiler chickens: 0.125 g of product/kg b.w. equal to 25 mg/kg b.w. of tylosin for 3-5 days.
Pigs: from 0.05 to 0.06 g of product/kg b.w. equal to 10-12 mg/kg b.w. of tylosin for 3-5 days.
Make sure the water system is accessible to the treated animals so that they may drink the needed water.
No other source of water must be available during treatment. Once treatment is complete, the water system
must be thoroughly cleaned, in order to prevent the intake of sub-therapeutic quantities of active principle.
Withdrawal periods: Meat and offal: milking calves: 24 days; broiler chicken: 1 day; pigs: 16 days.
Do not administer to broilers that lay eggs for human consumption.

Special storage conditions: This veterinary medicinal product does not require any special storage conditions. The date of expiry applies to a product in intact and properly stored package.
Shelf-life: 12 months

Shelf-life after first opening of the immediate packaging: 15 days
Shelf-life after dilution or reconstitution: 12 hours.

Special warnings:

Special warnings for each target species: The uptake of the veterinary medicines could be reduced due
to the disease. For animals with reduced intake of liquid feed, treatment must be administrated through
parenteral route, using a suitable injectable product, as instructed by a veterinarian. The repeated or prolonged use should be avoided, improving management practices by cleaning and disinfection.

Special precautions for use
Special precautions for use in animals: The use of the product should be based on sensitivity tests made
on bacteria isolated from animals to treat. If this is not possible, the therapy should be based on local
epidemiological information (regional or corporate) concerning sensitivity of target bacteria. The use of the product differently from the instructions of the SPC may increase the prevalence of tylosinresistant bacteria and may decrease treatment effectiveness with other antibiotics of the same or of other families, due to potential cross-resistance. Do not mix in solid feed. Keep the solution out of the reach of animals not under therapy or wild animals.
Special precautions to be taken by the person administering the medicinal product to animals: Avoid ingestion and contact with skin, eyes and mucous glands. Use protective gloves. In the event of accidental contact, wash thoroughly with soap and water. In case of an allergic reaction (swelling of the face, lips or eyes, or trouble breathing) when administering the product, or in the event of accidental ingestion, immediately inform your doctor and show him the illustrational leaflet or label. Do not smoke, eat or drink
while handling the product. Wash your hands with soap after using the product. Persons known to be
hypersensitive to macrolides or excipients must avoid contact with the veterinary medical product.
Use during pregnancy and lactation: Not allowed
Interactions with other veterinary medicinal products and other forms of interaction: Mutual cross-resistance between tylosin and desmycosin has been observed. Do not simultaneously administer with other
antimicrobials having the same action, such as other macrolides or lincosamides.
Overdose: Data unavailable. Do not exceed recommended doses.

Incompatibilities: Do not mix with other medicinal products

SPECIAL PRECAUTIONS TO TAKE WHEN DISPOSING OF UNUSED MEDICINAL OR WASTE PRODUCTS: All unused medicinal products or waste produced by the latter must be disposed of in accordance with local laws and handed over to the responsible waste collection centers for unused or expired medicinal products.

Presentations: bottles of 1 kg and 5 kg

Reg. number: IIT-06              

Batch No., MFG date and EXP date: see on package 

FOR VETERINARY USE ONLY

Keep out of the reach of children

Industria Italiana Integratori TREI S.p.A

42010 Rio Saliceto (RE) Italy - Via Affarosa, 4