Tylovectin 200 Solution for Injection for Cattle, Goats and Pigs

Revised December 2023
AN: 00440/2023
Goats:
Respiratory infections, metritis caused by Gram-positive microorganisms, mastitis
caused by Gram-positive microorganisms or Mycoplasma spp.
4.3 Contraindications
Do not administer to chickens, turkeys or horses.
Do not use in cases of hypersensitivity to the active substance, other macrolides or
any of the excipients.
4.4 Special warnings for each target species
None.
4.5 Special precautions for use
Special precautions for use in animals
Due to likely variability (time, geographical) in susceptibility of bacteria to tylosin,
bacteriological sampling and susceptibility testing are recommended. Official,
national and regional antimicrobial policies should be taken into account when the
veterinary medicinal product is used
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.
A high rate of in vitro
Brachyspira hyodysenteriae implying that the veterinary medicinal product will not be
sufficiently efficacious against swine dysentery.
The efficacy data do not support the use of tylosin for the treatment of bovine mastitis
caused by spp.
Where repeat injections are to be administered, use different sites for each injection.
Special precautions to be take by the person administering the veterinary medicinal
product to animals
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.
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.
People with known hypersensitivity to tylosin, benzylalcohol or propylene glycol
should avoid contact with the veterinary medicinal product.

Revised December 2023
AN: 00440/2023
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.
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.
Special precautions for the protection of the environment
Not applicable.
4.6 Adverse reactions (frequency and seriousness)
Cattle:
Very rare
(<1 animal / 10.000 animals
treated, including isolated
report(s)):
- Injection site swelling, injection site
inflammation
- Swollen vulva
- Anaphylactic shock
- Death
Undetermined frequency
(cannot be estimated from
available data)
- Hypersensitivity reaction
- Injection site lesion
Can persist for up to 21 days following administration
Pigs:
Very rare
(<1 animal / 10.000 animals
treated, including isolated
reports):
- Injection site swelling, Injection site
inflammation
- Anaphylactic shock
- Rectal oedema
- Erythema
- Pruritus
- Rectal prolapse (partial)
- Death
Undetermined frequency
(cannot be estimated from
available data)
- Hypersensitivity reaction
- Injection site lesion
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 its local representative or the national
competent authority via the national reporting system. See the package leaflet for
respective contact details.

Revised December 2023
AN: 00440/2023
4.7 Use during pregnancy, lactation or lay
Pregnancy:
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 according to the benefit/risk assessment by the responsible
veterinarian.
4.8 Interaction with other medicinal products and other forms of interaction
None known.
4.9 Amount(s) to be administered and administration route
For intramuscular or slow intravenous (cattle only) injection
Cattle (ruminants) and cattle (calves): 5 000 - 10 000 IU 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 in cattle.
Goats: 10 000 IU tylosin/kg bodyweight per day for 3 days (5 ml solution for injection
per 100 kg bodyweight).
Pigs: 5 000 IU to 10 000 IU of tylosin per kg bodyweight per day during 3 days,
2.5 to 5 ml of solution per 100 kg bodyweight.
In pigs do not administer more than 5 ml per injection site.
To ensure a correct dosage, body weight should be determined as accurately as
possible.
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.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
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.
4.11 Withdrawal periods
Cattle:
Meat and offal – 28 days
Milk – 108 hours
Goat:
Meat and offal – 42 days
Milk – 108 hours

Revised December 2023
AN: 00440/2023
Pigs:
Meat and offal – 16 days
5.