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Date: Tuesday, March 5, 2024 4:01

Description: 2015-Elanco-logo
Telephone: 01256 353131 (24 hr response) Veterinary Technical Services
Release 2.48
Tylan Soluble Powder for oral solution
 
Species: Cattle, Chickens, Pigs, Turkeys
Therapeutic indication: Pharmaceuticals: Antimicrobials: Oral preparations: Others
Active ingredient: Tylosin Tartrate
Product:Tylan Soluble Powder for oral solution
Product index: Tylan Soluble Powder for oral solution
Cattle - meat: 14 days
Pig - meat: Zero days
Poultry - meat: see notes
Poultry - eggs: Zero days
Withdrawal notes: Poultry meat - Chickens: Zero Days @ 20-50 mg/kg; 1 day @ 50-200mg/kg. Turkeys: Zero Days
Incorporating:
Qualitative and quantitative composition
Active substance:
Tylosin 100g activity per bottle as Tylosin Tartrate.
Tylosin 1000g activity per bag Tylosin Tartrate.
For a full list of excipients, see section Pharmaceutical Particulars
Pharmaceutical form
Powder for oral solution
A white to medium yellow powder.
Clinical particulars
Target species
For use in calves, pigs, chickens and turkeys .
Indications for use, specifying the target species
For the control of Mycoplasma synoviae airsacculitis in chickens and Mycoplasma gallisepticum S6 in chickens and turkeys. In the field tylosin has also proved useful in reducing the level of infection following stress associated with live vaccination.
As an aid in the control of outbreaks of necrotic enteritis in chickens caused by Clostridium perfringens.
For the prevention and control of enzootic pneumonia, and scours caused by organisms (e.g. Lawsonia intracellularis) sensitive to tylosin, in pigs.
For the control of pneumonia in cattle associated with mycoplasmata and Pasteurella multocida sensitive to tylosin.
For information regarding swine dysentery see section Special precautions for use.
Contraindications
Do not leave or dispose of water containing tylosin tartrate where it may be accessible to either animals not under treatment or to wildlife.
Do not use in known cases of hypersensitivity to tylosin or other macrolides.
Special warnings for each target species
None
Special precautions for use
Special precautions for use in animals
Use of the product should be based on susceptibility testing of the bacteria isolated from the animal. If this is not possible, therapy should be based on local (regional, farm level) epidemiological information about susceptibility of the target bacteria.
Official, national and regional antimicrobial policies should be taken into account when the product is used.
A high rate of in vitro resistance has been demonstrated in European strains of Brachyspira hyodysenteriae implying that the product will not be sufficiently efficacious against swine dysentery.
Use of the product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to tylosin and may decrease the effectiveness of treatment with other macrolides, lincosamides and streptogramin B due to the potential for cross-resistance.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Tylosin may induce irritation. Macrolides, such as tylosin, may also cause hypersensitivity (allergy) following injection, inhalation, ingestion or contact with skin or eye. Hypersensitivity to tylosin may lead to cross reactions to other macrolides and vice versa. Allergic reactions to these substances may occasionally be serious and therefore direct contact should be avoided.
To avoid exposure during preparation of the medicated drinking water, wear overalls, safety glasses, impervious gloves and wear either a disposable half mask respirator conforming to European Standard EN149 or a non-disposable respirator to European Standard EN140 with a filter to EN143. Wash hands after use.
In the event of accidental skin contact, wash thoroughly with soap and water. In case of accidental eye contact, flush the eyes with plenty of clean, running water.
Do not handle the product if you are allergic to ingredients in the product.
If you develop symptoms following exposure, such as skin rash, you should seek medical advice and show the physician this warning. Swelling of the face, lips and eyes or difficulty in breathing are more serious symptoms and require urgent medical attention.
Adverse reactions (frequency and seriousness)
None known
Use during pregnancy, lactation or lay
No adverse effects to tylosin have been seen in fertility, multi-generation or teratology studies.
Interaction with other medicinal products and other forms of interaction
None known
Amounts to be administered and administration route
For oral administration.
Recommendations for use in chickens and turkeys:
Tylan Soluble is administered in the drinking water at a concentration of 0.5 g per litre.
As an aid in the control of outbreaks of necrotic enteritis caused by Clostridium perfringens in chickens use Tylan in the drinking water for 5 days at a concentration of 0.15 g per litre water (150ppm), to provide 20-50 mg/kg bw, depending on the age and the water consumption of the birds.
Recommendations for use in pigs:
Tylan Soluble is administered in the drinking water to provide 25 mg tylosin/kg bodyweight. This may normally be achieved by adding 0.25g per litre.
Recommendations for use in calves:
One gram of tylosin activity per calf administered orally twice daily for seven to fourteen days. The tylosin tartrate may be incorporated into the milk or reconstituted milk replacer at the time of feeding.
To ensure a correct dosage, body weight should be determined as accurately as possible to avoid under-dosing.
Recommended programmes
a) Chickens and turkeys
For preventative medication the following programmes are recommended:
As an aid to mycoplasmosis prevention in chickens
Class of Stock
Age
Tylan Soluble at 0.5g per litre
Broiler
0-3 days
35 g per 1000 birds
4th week of life
35 g per 1000 birds
Layers and replacement pullets
0-3 days
35 g per 1000 birds
4th week of life
35 g per 1000 birds
9-12th week
48 hours medication
16th-20th week
48 hours medication
Breeders
0-3 days
50 g per 1000 birds
4th week of life
80 g per 1000 birds
9th, 12th, 16th, 20th, 24th weeks of age
48 hours medication
As an aid to mycoplasmosis prevention in turkeys
Class of Stock
Age
Tylan Soluble at 0.5g per litre
Table Turkeys
0-5 days
12.5 g per 100 birds
4th week of life
7.5 g per 100 birds
For treatment of mycoplasmosis:
Class of Stock
Tylan Soluble at 0.5g per litre
Broilers
24-72 hours medication
Layers and replacement pullets
48-72 hours medication
Turkeys
48-120 hours medication
As an aid in the control of necrotic enteritis:
Class of Stock
Tylan Soluble at 0.15g per litre
Broilers
5 days
Layers and Replacement pullets
5 days
b) Pigs
A medicated solution of drinking water should generally be administered until 24 hours after scouring or respiratory symptoms have ceased, normally 3-10 days. The diagnosis should be reviewed if there is no response after 5 days of medication.
Tylan Soluble requirements per tonne of pigs daily:
Disease Treatment
Tylan Soluble required
Water consumption (l) approx.
enzootic pneumonia
25 g
100 litres
Ileitis
5-10 g
100 litres
c) Calves
One gram of tylosin activity should be incorporated in milk or milk replacer twice daily for each calf. This should be continued for 7-14 days dependent on response.
The intake of medicated water depends on the clinical condition of the animals. In order to obtain the correct dosage, the concentration of Tylan Soluble has to be adjusted accordingly.
Overdose (symptoms, emergency procedures, antidotes), if necessary
There is no evidence of tylosin toxicity in animals, at dose rates of up to 1000 mg/kg.
Withdrawal periods
Species
Indications
Treatment Duration (days)
Dose
Meat Withdrawal Period (days)
Egg Withdrawal period (days)
Chickens
For the control of chronic respiratory disease
5
500 mg/litre water (50-200 mg tylosin/kg bw)
1
Zero
Chickens
As an aid in the control of outbreaks of necrotic enteritis caused by Clostridium perfringens.
5
150 mg /litre water (20-50 mg tylosin/kg bw)
Zero
Zero
Turkeys
For the control of chronic respiratory disease
5
500 mg/litre water
Zero
N/A
Pigs
For the prevention and control of enzootic pneumonia, swine dysentery and other scours caused by organisms (e.g. Lawsonia intracellularis) sensitive to tylosin
3-10
250 mg/litre water (25 mg tylosin/kg bw)
Zero
N/A
Calves
For the control of pneumonia associated with mycoplasmata and Pasteurella multocida sensitive to tylosin.
7-14
1000 mg per calf twice daily
14
N/A
Tylan Soluble Powder for Oral Solution - Withdrawal Periods
Pharmacological particulars
Pharmacotherapeutic group: Macrolides, ATCvet code: QJ01FA90
Pharmacodynamic properties
Tylosin is a macrolide antibiotic produced by a strain of Streptomyces fradiae. It exerts its antimicrobial effect by inhibiting protein synthesis of susceptible micro-organisms.
The tylosin spectrum of activity includes Gram-positive bacteria including Clostridium perfringens and some Gram-negative strains such as Pasteurella and Mycoplasma spp. at concentrations of 16µg/ml or less.
Pharmacokinetic particulars
Absorption: Tylosin reaches maximal blood levels between 1 and 3 hours after an oral dose. Minimal or no blood levels remain 24 hours after an oral dose.
Distribution: After oral doses were given to pigs, tylosin was found in all tissues, between 30 minutes and two hours after administration, except for the brain and spinal cord.
Biotransformation and Elimination: It has been shown that most of the material which is excreted is to be found in the faeces and consists of tylosin (factor A), relomycin (factor D) and dihydrodesmycosin.
Pharmaceutical particulars
List of excipients
None
Incompatibilities
None known
Shelf life
Shelf-life of the veterinary medicinal product as packaged for sale: 3 years.
Shelf-life after dilution according to directions: 24 hours
Special precautions for storage
Store in tightly closed original container.
Do not store above 25°C. Store in a dry place.
Any medicated water which is not consumed within 24 hours should be discarded.
Nature and composition of immediate packaging
Tylan Soluble is presented in high density polythene bottles with screw caps containing 100g tylosin activity, or block-bottomed laminated aluminium/polythene/paper bags containing 1000g tylosin activity.
Not all pack sizes may be marketed.
Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Any unused veterinary medicinal product or waste material derived from such veterinary medicinal products should be disposed of in accordance with national requirements.
Marketing Authorisation Holder (if different from distributor)
N/A
Marketing Authorisation Number
Vm 00879/4175
Significant changes
Date of the first authorisation or date of renewal
Date: 25 May 1993
Date of revision of the text
Date: October 2014
Any other information
Legal category
Legal category: POM-V
GTIN
GTIN description:Tylan Soluble Powder for oral solution 100g Bottle
GTIN:05014602853105
GTIN description:Tylan Soluble Powder for oral solution 1kg
GTIN:05014602853099