Target Species
Cattle, pigs.
Indications for use for each target species
Infections caused by microorganisms susceptible to tylosin.
Cattle (adult):
- Treatment of respiratory infections, metritis caused by Gram-positive micro-organisms, mastitis caused by Streptococcus spp., Staphylococcus spp., or Mycoplasma and interdigital necrobacillosis caused by Fusobacterium necrophorum i.e. panaritum or foot rot
Cattle (calves):
- Treatment of respiratory infections and necrobacillosis (calf diphtheria caused by Fusobacterium necrophorum).
Pigs:
- Treatment of enzootic pneumonia caused by Mycoplasma hyopneumoniae, haemorrhagic enteritis (Porcine proliferative haemorrhagic enteropathy due to Lawsonia intracellularis), erysipelas caused by Erysipelothrix rhusiopathiae and metritis.
- Treatment of arthritis caused by Mycoplasma and Staphylococcus spp.
Contraindications
Do not administer to chickens or turkeys in which intramuscular injection may be fatal.
Do not administer to horses or other equines in which injection of tylosin may be fatal.
Do not administer to animals with known hypersensitivity to tylosin, other macrolides or any of the excipients.
Special warnings
None.
Special precautions for use
Special precautions for safe use in the target species:
Use of the veterinary medicinal 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.
The efficacy data do not support the use of tylosin for the treatment of bovine mastitis caused by Mycoplasma spp.
Use of the veterinary medicinal 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 macrolide antibiotics due to the potential for cross resistance.
For administration by the intramuscular route only. Use different injection sites for repeated injections.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Macrolides, such as tylosin may 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. People with known hypersensitivity to tylosin should avoid contact with the veterinary medicinal 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. Care should be taken to avoid accidental self-injection. In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Macrolides, such as tylosin may 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. People with known hypersensitivity to tylosin should avoid contact with the veterinary medicinal 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. Care should be taken to avoid accidental self-injection. In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Special precautions for the protection of the environment:
Not applicable
Adverse events
Cattle:
Very rare (<1 animal / 10,000 animals treated, including isolated reports): | Injection site reaction Swollen vulva Anaphylactic shock Death |
Undetermined frequency (cannot be estimated from the available data): | Blemishes at the injection site (1) |
1 - can persist for up to 21 days following administration.
Pigs:
Very rare (<1 animal / 10,000 animals treated, including isolated reports): | Injection site reaction Rectal oedema Anaphylactic shock Erythema Pruritus Rectal prolapse (partial) (1) Death |
Undetermined frequency (cannot be estimated from the available data): | Blemishes at the injection site (2) |
1 - "Rosebudding", 2 - can persist for up to 21 days following administration.
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or the national competent authority via the national reporting system. See the package leaflet for respective contact details.
Use during pregnancy, lactation or lay
The safety of the veterinary medicinal product has not been established during pregnancy and lactation.
Studies in laboratory animals have not produced any evidence of teratogenic, foetotoxic or maternotoxic effects. No studies have been conducted in the target species. Use only in accordance with the benefit/risk assessment by the responsible veterinarian.
Interaction with other medicinal products and other forms of interaction
Lincosamide and aminoglycoside antibiotics can antagonise the action of tylosin.
Administration routes and dosage
For intramuscular injection:
Cattle: 5-10 mg tylosin/kg bodyweight per day for 3 days (2.5 to 5 ml solution for injection per 100 kg bodyweight). Maximum injection volume per injection site should not exceed 15 ml.
Pigs: 5-10 mg tylosin/kg bodyweight per day for 3 days (2.5 to 5 ml solution for injection per 100 kg bodyweight). In pigs do not administer more than 5ml per injection site.
The closures should not be broached more than 15 times. In order to prevent excessive broaching of the stopper, a suitable multiple dosing device should be used.
To ensure a correct dosage, body weight should be determined as accurately as possible.
Symptoms of overdose (and where applicable, emergency procedures and antidotes)
Pigs and cattle (calves): Intramuscular injection of 30 mg/kg bodyweight per day (three times maximum recommended dose) for five days produced no adverse effects.
Special restrictions for use and special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance
Not applicable
Withdrawal period(s)
Pigs:
Meat – 16 days
Cattle:
Meat – 28 days
Milk – 108 hours.