DOPHATYL-JECT (TYLOSIN) ANTI-INFECTIVE INJECTABLE 100ML

DOPHATYL-JECT (TYLOSIN) ANTI-INFECTIVE INJECTABLE 100ML

Dophatyl-ject 200 000 IU/ml solution for injection for cattle, sheep, goats and pigs.

COMPOSITION:
Each ml contains:
Active substance:
Tylosin …… 200,000 IU
Excipients:
Benzyl alcohol (EI 519) …… 40 mg
Clear yellow solution, free of visible particles.

INDICATIONS:
Bovine (adult):
Treatment of respiratory infections, metritis caused by Gram-positive microorganisms, mastitis caused by Streptococcus spp., Staphylococcus spp. and interdigital necrobacillosis such as panaritis or pododermatitis.

Calves:
Treatment of respiratory infections and necrobacillosis.
Sheep and goats:
Treatment of respiratory infections, metritis caused by Gram-positive microorganisms, mastitis caused by Gram-positive microorganisms and Mycoplasma spp.
Pigs:
Treatment of enzootic pneumonia, hemorrhagic enteritis, measles and metritis.
Treatment of arthritis caused by Mycoplasma spp. and Staphylococcus spp.
For information on swine dysentery, see the section “Special warnings”.

CONTRAINDICATIONS:
Do not use in cases of hypersensitivity to the active substance, other macrolides or any of the excipients.
Do not use in animals with renal and/or hepatic impairment.
Do not use in horses or other horses and poultry, as injection of tylosin can be fatal in these species.
Do not use in suspected cases of cross-resistance to other macrolides.

SIDE EFFECTS:
Cattle:
– Common (1 to 10 animals/100 animals treated): injection site inflammation1, injection site necrosis1, injection site hemorrhage1.
– Very rare (<1 animal/10,000 animals treated, including isolated reports): allergic reactions, anaphylactic shock, death, swelling of the vulva.
– Frequency not determined (cannot be estimated based on available data): tachycardia, tachypnea.
1May persist for up to 21 days after administration.

TARGET SPECIES:
Cattle, sheep, goats and pigs.

DOSAGE FOR EACH SPECIES, ROUTE AND METHOD OF ADMINISTRATION:
Sheep, goats and pigs: intramuscular administration.
Cattle: intramuscular and intravenous administration.

Cattle: 5 000 to 10 000 IU tylosin/kg body weight/day for 3 days (i.e. 2.5 to 5 ml solution for injection per 100 kg body weight). The maximum volume administered at each injection site should not exceed 15 ml. Intravenous injections should be given slowly.
Sheep and goats: 10 000 IU tylosin/kg body weight/day for 3 days (i.e. 5 ml solution for injection per 100 kg body weight). For ewes over 50 kg body weight, administration should be carried out by injection at two different sites. The maximum volume administered at each injection site should not exceed 2.5 ml.
Pigs: 5 000-10 000 IU tylosin/kg body weight/day for 3 days (i.e. 2.5 to 5 ml solution for injection per 100 kg body weight). The maximum volume administered at each injection site should not exceed 5 ml.

RECOMMENDATIONS ON CORRECT ADMINISTRATION:
To ensure the correct dosage, body weight must be determined as accurately as possible.
The cork should not be punctured more than 20 times.
To prevent excessive perforation of the stopper, an appropriate multi-dosing device should be used.

WAITING PERIODS:
Cattle: Meat and offal: 28 days.
Milk: 108 hours.
Sheep and goats: Meat and offal: 42 days.
Milk: 108 hours.
Pigs: Meat and offal: 16 days.

SPECIAL PRECAUTIONS FOR STORAGE:
Keep out of sight and reach of children.
Do not store at a temperature higher than 250C.
Store the bottle in the outer carton to protect from light.
Do not use this veterinary medicinal product after the expiry date which is stated on the carton and bottle. The expiration date refers to the last day of that month.
Shelf life after the first opening of the bottle: 28 days.

SPECIAL WARNINGS:
Special Warnings:
Cross-resistance between tylosin and other macrolides has been demonstrated. The use of the veterinary medicinal product should be carefully considered when susceptibility tests have shown resistance to macrolide antibiotics, as its efficacy may be reduced. A high rate of resistance in vitro has been demonstrated in European strains of Brachyspira hyodysenteriae implying that the veterinary medicinal product will not be effective enough against swine dysentery. Efficacy data do not support the use of tylosin for the treatment of bovine mastitis caused by Mycoplasma spp.
Special precautions for safe use in target species:
The use of the veterinary medicinal product should be based on the identification and testing of the susceptibility of the target pathogen(s). If this is not possible, therapy should be based on epidemiological information and knowledge of the susceptibility of target pathogens at farm or local/regional level. The use of the veterinary medicinal product must be in accordance with official, national and regional antimicrobial policies. An antibiotic with a lower risk of antimicrobial resistance selection (lower AMEG category) should be used for first-line treatment, if susceptibility testing suggests the likely efficacy of this approach. Feeding calves residual milk containing antimicrobial residues should be avoided until the end of the milking waiting period (except for the colostral phase), as it could select antimicrobial-resistant bacteria from the calf’s intestinal microbiome and increase the fecal elimination of these bacteria.
Special precautions to be taken by the person administering the veterinary medicinal product to animals:
Macrolides, such as tylosin, may cause hypersensitivity (allergy) after injection, inhalation, ingestion, or contact with the skin or eyes. Hypersensitivity to tylosin can lead to cross-reactions with other macrolides and vice versa. Benzyl alcohol and propylene glycol can also cause hypersensitivity reactions. Allergic reactions to these substances can occasionally be serious and therefore direct contact should be avoided. Do not handle the medicine if you are allergic to any of the ingredients of the veterinary medicinal product. If symptoms develop from exposure, such as rash, seek medical advice and show the package leaflet or label. Swelling of the face, lips and eyes or shortness of breath are more serious symptoms and require urgent medical attention. The veterinary medicinal product may cause eye and skin irritation. Avoid contact with eyes and skin. If this happens, wash the area thoroughly with water. 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 product label. Do not smoke, eat or drink while handling the medicine. Wash your hands after use.
Pregnancy and lactation:
Studies in laboratory animals have not demonstrated teratogenic, foetotoxic or maternotoxic effects. The safety of the veterinary medicinal product has not been established in the target species during gestation and lactation. Use only in accordance with the benefit-risk assessment carried out by the responsible veterinarian.

Overdose:

Pigs and calves: intramuscular injection of 30 000 IU tylosin/kg body weight/day for 5 consecutive days produced no adverse effects.
Major incompatibilities:
In the absence of compatibility studies, this veterinary medicinal product should not be mixed with other veterinary medicinal products.

SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED PRODUCT OR WASTE, AS APPROPRIATE:
Medicines should not be disposed of in wastewater or household waste. Use the systems for the retumming of unused veterinary medicinal products or waste derived from them, in accordance with local requirements and applicable national collection systems. These measures should contribute to the protection of the environment. Ask your veterinarian for information on how to dispose of medicines that are no longer needed. The veterinary medicinal product should not enter waterways, as florfenicol can be dangerous to fish and other organisms.

DIMENSION:
Bottle x 100 ml.