TILODEM 50

Water Soluble Powders

Tylosin tartrate 500 mg/g, water-soluble powder for pigs and poultry.

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

TILODEM 50 as Tylosin tartrate. 500 mg/g, water-soluble powder for pigs and poultry.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION

1 gram of Tilodem 50 contains:

Tylosin tartrate ….…………………………..…. 500 mg

Excipient qs ad. ………………………………………….……. 1 g

For full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

White, water-soluble powder.

4. CLINICAL PARTICULARS

4.1. Target species

Pigs and poultry.

4.2. Indications for use, specifying the target species

Tilodem 50 is used for both local and systemic action and is a reliable antibiotic for treating the infections produced by penicillin-resistant bacterial strains. It is used in pigs and poultry for treatment and control of infections produced by susceptible bacteria from genera: Staphylococcus, Streptococcus, Bacillus, Erysipelothrix rhusiopathiae, Corynebacterium, Listeria, Haemophillus, Brucella, Fusobacterium, Clostridium spp. Mycoplasma spp., Haemophillus spp., Serpulina hyodisenteriae, Chlamydia, Rickettsia, Borellia anserina and Pasteurella spp.

4.3. Contraindications

Do not give to animals with known hypersensitivity to tylosin or other macrolides.

4.4. Special warnings for each target species

Throughout duration of the treatment, animals should drink only medicated water and eat only medicated feed.

4.5. Special precautions for use

Special precautions for use in animals

The product must be diluted before administration to the animals.

Use of the product should be based on susceptibility testing of the bacteria isolated from animal. If this is not possible, therapy should be based on local (regional, farm level) epidemiological information about susceptibility of the target bacteria.

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

People with known hypersensitivity to any of the product ingredients should avoid contact with the veterinary medicinal product. Persons involved in the drug administration should wear special protection equipment (dust mask, eye protectors and rubber gloves).

The direct contact of persons with TILODEM 50 solution should be avoided, first of all concerning eyes, skin and clothing. In case of accidental exposure, wash eyes with water; for skin exposure, wash with soap and water. Wash hands and exposed skin after use.

In case of accidental ingestion or the occurrence of symptoms characterized by skin rash, seek medical advice. Serious symptoms such as swelling of face, lips or eye lids, accompanied by breath difficulties, need immediate medical attention.

4.6. Adverse reactions (frequency and seriousness)

There are no undesirable effects at recommended dosages.

4.7. Use during pregnancy, lactation and layering periods

Laboratory studies in rodents have not produced any evidence of teratogenic, fetotoxic or maternotoxic effects.

4.8. Interactions with other medicinal products

The occurrence of cross-resistance with other macrolides and lincomycin is possible. The product should not be mixed with other drugs.

4.9. Amounts to be administered and administration route

In pigs: the product is administered via feed or drinking water in dosage of 25 – 30 mg tylosin/kg (equivalent to 31,25 – 37,5 mg tylosin tartrate/kg b.w.) corresponding to 62,5 – 75 mg Tilodem 50/kg body weight/day, for 4-5 consecutive days.

In poultry: the product is administered via feed or drinking water in dosage of 30 – 40 mg tylosin/kg (equivalent to 37,5 – 50 mg tylosin tartrate/kg b.w.) corresponding to 75 – 100 mg Tilodem 50 /kg body weight/day for 4-5 consecutive days.

Based on the recommended doses and the number and weight of the animals to be treated, the exact daily amount of TILODEM 50 should be calculated according to the following formula:

Tilodem 50 apa

In drinking water:

Tilodem 50 furaj

The uptake of medicated water or feed is dependant on the clinical condition of animals. In order to obtain the correct dosage, the concentration in drinking water may have to be adjusted.

To ensure a correct dosage, body weight should be determined as accurately as possible to avoid underdosing.

Medicated drinking water should be prepared fresh every 24 hours.

4.10. Overdose (symptoms, emergency procedures, antidotes)

In case of overdosage may occur phenomena of intolerance, especially digestive (diarrhea and vomit). Remove medicated water and institute the symptomatic therapy.

4.11. Withdrawal period

Edible tissues of pig: 10 days after cessation of oral medication.

Edible tissues of poultry: 4 days after cessation of oral medication.

Eggs: 4 days after cessation of oral medication.

 

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: macrolides, ATC vet. code: QJ01FA90.

5.1. Pharmacodynamic properties

Tylosin has bacteriostatic action by binding to a certain locus on 50S ribosomal units, blocking the protein synthesis.

Tylosin is very effective in multiplication phase of Gram-positive bacteria from genera Staphylococcus, Streptococcus, Bacillus, Erysipelothrix, Corynebacterium, Listeria, Haemophillus, Brucella, Fusobacterium, Clostridium) and also against Mycoplasma, Haemophillus, Serpulina hyodisenteriae, Chlamydia, Rickettsia and Borellia anserina.

Amongst Gram-negative bacteria, tylosin is active against Pasteurella.

Tylosin is used only in veterinary medicine.

5.2. Pharmacokinetic properties

Biodisponibility. Tylosin odată ajunsă în tractusul digestiv în contact cu sucul intestinal se dizolvă şi devine disponibilă pentru acţiune locală şi absorbţie sistemică.

Absorbţie. Tilozina se absoarbe uşor din intestin.

Distribuţie. După administrarea medicamentului pe cale orală concentraţia plasmatică maximă apare la 1-2 ore. Se distribuie bine în ţesuturi unde concentraţiile sunt mai mari decât cele din sânge şi tinde să se concentreze în splină, ficat, rinichi şi în special în pulmon şi ţesuturile inflamate. Difuzează bine în lichidul pleural şi peritoneal. În sânge circulă legată de proteinele plasmatice. După administrare pe cale orală concentraţia anti-microbiană se menţine timp de aproximativ 10-12 ore. În ţesuturile inflamate concentraţia de antibiotic creşte de câteva ori faţă de cea din sânge.

Biotransformare. În ficat tilozina se transformă în factorul A, factorul B şi dihidrodesmicosină. Mai puţin de 0,25 mg/kg de reziduu de tilozină marcată cu C14 a fost găsită în ficat şi rinichi după o doză de 10 m,g/kg administrată zilnic timp de 3 zile la şobolan. La porc s-a administrat o doză de 110 mg/kg tilozină bază marcată cu C14 în hrană, zilnic timp de 4 zile. La 4 ore după ultima administrare s-a evidenţiat la animalele sacrificate în ficat şi rinichi sub 0,04 mg/kg tilozină marcată în grăsime. În ficat au fost evidenţiaţi 5-6 metaboliţi. Prin analiză spectrometrică de masă a fecalelor recoltate de la aceşti purcei s-a identificat 3 metaboliţi: factorul A, factorul B şi dihidrodesmicosina.

Eliminare. Se elimină sub formă activă în principal pe cale biliară şi prin fecale sub forma a 3 metaboliţi: factorul A, factorul B şi dihidrodesmicosina.

6. PHARMACEUTICAL PARTICULARS

6.1. List of excipients

Propyl gallate

Disodium edetate

Orthophosphoric acid

Puriffied water

6.2. Incompatibilities

None known.

6.3. Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 2 years.
Shelf life after dilution in drinking water, according to directions: 24 hours.

Shelf-life after first opening of package: 28 days. Close tight the recipient after each use.

6.4. Special precautions for storage

The product should be stored in original packaging at 15-25oC, protected from direct sunlight.

6.5 Nature and composition of immediate packaging

Bags containing 10g, 25g, 50g, 100g, 500g, 1000g, 5kg, 10kg and sacks of 25kg, 50kg.
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.

6.6 Special precautions for the disposal of unused medicinal product or waste materials derived from the use of such products

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 local requirements.

PROHIBITION OF SALE, SUPPLY AND/OR USE

Not applicable.