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Date: Tuesday, August 9, 2022 16:09

Description: 2015-Elanco-logo
Telephone: 01256 353131 (24 hr response) Veterinary Technical Services
Release 2.86
Tylan 200, 200 mg/ml Solution for Injection
 
Species: Cattle, Pigs
Therapeutic indication: Pharmaceuticals: Antimicrobials: Injections
Active ingredient: Tylosin
Product:Tylan 200, 200 mg/ml Solution for Injection
Product index: Tylan 200, 200 mg/ml Solution for Injection
Cattle - milk: 108 hours
Cattle - meat: 28 days
Pig - meat: 16 days
Qualitative and quantitative composition
Active substance:
Tylosin activity 200 mg/ml
Excipients:
Benzyl alcohol 40 mg/ml
For a full list of excipients, see Pharmaceutical Particulars
Pharmaceutical form
Solution for Injection.
Sterile yellow aqueous solution.
Clinical particulars
Target species
Tylan 200 mg/ml Solution for Injection is indicated for use in cattle and pigs.
Indications for use, specifying the target species
Tylan 200 mg/ml injection is indicated in all conditions associated with bacteria sensitive to tylosin which includes organisms in the following genera:
Streptococcus
Campylobacter
Bacillus
Spirochaetes
Staphylococcus
Chlamydia
Corynebacterium
Fusiformis
Clostridium
Pasteurella
Erysipelothrix
Tylan 200 mg ml injection has been successfully used in respiratory and genito-urinary tract infections, otitis, cellulitis and secondary bacterial conditions associated with virus disease or post operative infections.
Specific disease entities treated successfully with Tylan include swine dysentery, erysipelas and enzootic pneumonia in pigs, foul in the foot, mastitis and calf pneumonia in cattle.
Contraindications
Tylan 200 should not be given to chickens or turkeys.
Do not administer to horses or other equines in which injection of tylosin may be fatal.
Special warnings for each target species
None.
Special precautions for use
(i) 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 epidemiological information.
For administration by the intramuscular route only.
Use different injection sites for repeat injections.
The efficacy data do not support the use of tylosin for the treatment of bovine mastitis caused by Mycoplasma spp.
(ii) Special precautions to be taken by the person administering the veterinary medicinal product to animals
Care should be taken to avoid accidental self-injection.
If accidental self-injection occurs, seek medical attention immediately.
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.
Wash hands after use.
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.
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.
(iii) Other precautions
Blemishes may occur at the site of injection and can persist for up to 21 days following administration.
Adverse reactions (frequency and seriousness)
Possible adverse reactions attributed to the product when used as recommended and their frequency are: In very rare cases the following have been observed;
- swelling/inflammation at the site of injection,
- vulvular swelling in cattle,
- oedema of the rectal mucosa, partial anal protrusion (‘rosebudding’)
- erythema and pruritus in pigs.
- Anaphylactic shock and death.
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 observed.
Amounts to be administered and administration route
Tylan should be given by intramuscular injection at the following dose rates:
Cattle and calves: 4 to 10 mg per kg bodyweight daily.
Pigs: 2 to 10 mg per kg bodyweight daily.
If there is no response to treatment in 3 days, diagnosis and treatment should be reassessed.
The maximum injection volume for cattle is limited to 15ml per injection site.
In pigs do not administer more than 5 ml per injection site.
To ensure the correct dosage, bodyweight should be determined as accurately as possible to avoid under dosing.
Overdose (symptoms, emergency procedures, antidotes), if necessary
Pigs and calves: Intramuscular injection of 30mg/kg bodyweight per day (three times maximum recommended dose) for five days produced no adverse effects.
The LD50 for subcutaneous injection of tylosin in mice is estimated to be >2500mg/kg bodyweight.
Withdrawal period(s)
Pigs: Meat and offal - 16 days
Cattle: Meat - 28 days
Cattle: Milk - 108 hours
With cows milked twice daily, milk for human consumption may be taken only from 108 hours i.e. at the 9th milking) after the last treatment. With other dosing routines, the basis of the veterinary surgeons advice should be that milk may be taken for human consumption only after the same period from the last treatment (i.e. with three times a day milking, milk for human consumption may be taken only from 108 hours i.e. at the 14th milking).
Pharmacological particulars
Pharmacotherapeutic group: Macrolides
ATC vet 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, and some Gram-negative strains such as Pasteurella, at concentrations of 16µg/ml or less. It is not generally active against anaerobes.
Pharmacokinetic particulars
Absorption: Following intramuscular injection, tylosin blood levels peak 1-2 hours post-injection. Duration of activity is approximately 12 hours.
Distribution, Biotransformation and Elimination: Tylosin levels of 1.4 to 1.6 and 2.2 to 6.7 µg/ml were recorded in serum and lung tissue respectively following intramuscular injection of 8.8mg/kg bodyweight in pigs. Measurable amounts of tylosin were still present in both serum and lung tissue at 12 hours post injection. Tylosin concentrations were greater in lung tissue than serum at all sample times.
Pharmaceutical particulars
List of excipients
Propylene glycol
Water for Injection
Incompatibilities
Do not mix with other solutions, since this may cause precipitation of the active ingredient.
Shelf life
Shelf-life of the veterinary medicinal product as packaged for sale: 18 months.
Shelf life after first opening of the immediate packaging: 28 days.
Special precautions for storage
Do not store above 25°C.
Following withdrawal of the first dose use the product within 28 days. Discard unused material.
Nature and composition of immediate packaging
50ml, 100 ml or 250 ml clear glass vials sealed with a white or grey chlorobutyl rubber bung with aluminium overseal. Each vial is packed into a carton.
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 materials derived from such products should be disposed of in accordance with national requirements.
Marketing Authorisation Holder (if different from distributor)
N/A
Marketing Authorisation Number
Vm 00879/4204
Significant changes
Date of the first authorisation or date of renewal
5 January 1996
Date of revision of the text
February 2021
Any other information
Legal category
Legal category: POM-V
GTIN
GTIN description:Tylan 200, 200 mg/ml Solution for Injection
GTIN:05014602853075