NAM PHUC THINH TRADING CO., LTD

OSSIBIOTIC 200

Compositions:
1 g of product contains: Oxytetracycline dehydrate equivalent to Oxytetracycline 200 mg; ExcipientsEDTA and other q.s. to 1 g

Pharmaceutical form: Oral powder

Target species: Calves, swine, meat/broilers, turkeys,laying hens and rabbits.

Indications:

Calves: pasteurellosis, complicationsof the digestive and respiratory system viral diseases,enzootic pneumonia caused by oxytetracyclinesensitive bacteria.
Broilers, laying hens and turkeys: bacterial diseases ofthe respiratory, gastrointestinal and genital systems and bacterial septicaemia caused by oxytetracyclinesensitive bacteria.
Rabbits: colibacillosis, salmonellosis, pasteurellosis.
Pigs: bacterial diseases of the respiratory and intestinalsystems caused by oxytetracycline-sensitive bacteria.

Contraindications:The product is contraindicatedin subjects with known hypersensitivity to any ofthe tetracyclines and in those with renal/hepaticdysfunction.Do not administer to turkeys producing eggs for human consumption.

Adverse reactions:Oral administration of thismedicine may affect the balance of the intestinalmicrobial flora in cattle that completed the milk feedingphase. If any serious effects or other effects not listedin this label are noticed, please inform the veterinarianresponsible.

Dosage, route and method of administration: The product should be administered in drinking water following the indicationsprovided by the Veterinarian, paying attention to avoidexceeding the daily dosage allowed, in mg/kg b.w.

Calves: from 12.5 to 20 g of product per 100 kg bodyweight, equal to 25 – 40 mg/ kg b.w. of Oxytetracycline.
Broilers and turkeys: from 20 to 35 g of product per100 kg body weight, equal to 40 – 70 mg/ kg b.w. ofOxytetracycline.
Laying hens: from 12.5 to 25 g of product per 100 kg bodyweight, equal to 25 – 50 mg/ kg b.w. of Oxytetracycline.
Rabbits: from 20 to 40 g of product per 100 kg bodyweight, equal to 40 – 80 mg/ kg b.w. of Oxytetracycline.
Pigs: from 10 to 25 g of product per 100 kg body weight, equal to 20 – 50 mg/ kg b.w. of Oxytetracycline.
Administer only in liquid feed or drinking water. Do not mix in solid feed.
Treatment period: 3-5 days.
To avoid under dosage, the body weight must bemeasured in the most accurate way possible.
The consumption of the medicated water depends onthe clinical conditions of animals.

Withdrawal periods:Meat and offal: Calves: 13 days; Broilers: 8 days; Turkeys: 9 days; Pigs: 9
days; Rabbits: 12 days. Eggs: Laying hens: 5 days.

Special storage conditions: Keep in a dryplace, away from direct sunlight. Keep out of reach ofchildren.
Shelf-life:24 months

Shelf-life after first opening of the container:3 months
Shelf-life after dilution or reconstitution according to directions: 8 hours.

Special warnings:

Special warnings for each target species: The uptakeof the veterinary medicines could be reduced caused bythe disease. For animals with reduced intake ofwater, treatment must be administrated viaparenteral route, using a suitable injectable productaccording to the advice of the veterinarian.The repeated or prolonged use should beavoided, improving management practices bycleaning and disinfection.

Special precautions for use
Special precautions for use in animals: The productshould be used based on sensitivity tests to isolatedbacteria in treated animals. If this is not possible, thetherapy should be based on local epidemiologicalinformation (regional or corporate) concerningsensitivity of target bacteria. Using the productdifferently from the instructions indicated in the leafletmay increase the prevalence of tetracycline-resistantbacteria and may decrease treatment effectiveness withother antibiotics of the same or of other families, due topotential cross-resistance. Keep the medicated solutionout of the reach of animals not under therapy or wildanimals.
Special precautions to be taken by the personadministering the medicinal product to animals:
Use protective gear when handling the product, i.e.protective clothing, gloves and mask; do not inhale,avoid contact with skin and eyes. In the event ofaccidental contact, wash thoroughly with soap andwater. Do not eat, drink or smoke when handling
the product; wash your hands after use. Personsknown to be hypersensitive to the active principlemust avoid contact with the veterinary medicalproduct.

Use during pregnancy and lactation: Theadministration of this medicine during the first phasesof pregnancy may cause an increase of foetal resorptionrate in rabbits. The antibiotic diffuses quickly acrossthe placenta and goes into the blood, membranes andtissues of the foetus and may cause tooth discolourationand hypoplasia as well as delays in longitudinal bone
growth. The use of tetracyclines during pregnancy orlactation is not recommended as they are depositedirreversibly in the growing bones.
Interactions with other veterinary medicinalproducts and other forms of interaction: Antibioticabsorption is low if administered together with otherproducts that contain high amounts of calcium andmagnesium, iron or aluminium.Since the tetracyclines are antibiotics having abacteriostatic action, the interaction with bactericidalantibiotics may lead to a decrease of the therapeuticactivity; concomitant administration is notrecommended.
Overdose: There are no known symptoms fromoverdose. Do not exceed recommended doses.

SPECIAL PRECAUTIONS FOR THE DISPOSAL OFUNUSED PRODUCT OR WASTE MATERIALS,IF ANY: All unused medicinal products or wastematerials derived from such medicinal productsshould be disposed of according to locallegislation and sent to usual points of collectionfor unused or expired medicines

Presentations: bag of 1 kg and 5 kg

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