Oxitetraciclina / Oxytetracycline Ro Forte 50 %, Multispecies oral powder

ORAL ANTIINFECTIVE MULTISPECIES OXYTETRACYCLINE  RO FORTE

OXYTETRACYCLINE RO FORTE, 500 mg/g, oral powder for cattle, pigs, sheep, goats and chickens (broilers, replacement young, laying hens).

STATEMENT OF ACTIVE SUBSTANCES AND OTHER INGREDIENTS:
1 gram of powder contains:
Active substance:
Oxytetracycline hydrochloride …… 500 mg
Yellow powder for use in drinking water.

INDICATIONS:
The product is recommended for the prevention (in herds where the diagnosis has been confirmed) and treatment of the following conditions sensitive to the action of the active substance:
– in cattle: indigestion due to overload and flatulence;
– in calves, lambs, kids: gastroenteritis, colibacillosis, pneumonia of various etiology, calf diphtheria, diseases caused by germs sensitive to oxytetracycline, omphalophlebitis, genitourinary tract infections;
– in pigs: lung diseases, gastrointestinal infections, salmonellosis, colibacillosis;
– in chickens (broilers, replacement young, laying hens): mycoplasmosis, cholera, colibacillosis, salmonellosis.

CONTRAINDICATIONS:
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.

ADVERSE REACTIONS:
Rare (1 to 10 animals/10,000 animals treated) – hypersensitivity reaction1.
1Treatment should be discontinued and symptomatic treatment should be implemented.
Reporting of adverse events is important. It allows continuous monitoring of the safety of a product. If you notice any side effects, even those not already listed in this leaflet or you think that the medicine has not had any effect, please contact your veterinarian first. You can also report adverse events to the Marketing Authorisation Holder or its local representative using the contact details provided at the end of this leaflet or via the national reporting system: farmacovigilenta@ansvsa.ro; icbmv@icbmv.ro.

TARGET SPECIES:
Cattle, pigs, sheep, goats and chickens (broilers, replacement young, laying hens).

DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION:
Administer in drinking water, at the following doses:
– in cattle: 1.5-2 g product/100 kg body weight, single administration;
– in piglets, lambs and kids: 0.3-0.4 g product/10 kg body weight/day, for 5-7 days;
– in adult pigs: 0.12-0.16 g product/10 kg body weight, for 5-7 days;
– in chickens (broilers, replacement young, laying hens): 600 g product/100 liters of water, for 5-7 days.

RECOMMENDATIONS ON CORRECT ADMINISTRATION:
The water intake is dependent on the clinical condition of the animals. To obtain the correct dose, the concentration of the active substance in the drinking water will have to be adjusted accordingly. To ensure the correct dosage, the body weight of the animals must be calculated as accurately as possible, in order to avoid underdosing the product. The daily dose is added to the drinking water, so that the entire quantity is consumed within 24 hours. A new quantity of medicated water should be freshly prepared every 24 hours.

WITHDRAWAL PERIOD(S):
Meat and offal: 10 days.
Milk: cattle: 10 days; sheep: 7 days; goats: 6 days.
Eggs: 4 days.

SPECIAL STORAGE PRECAUTIONS:
Keep out of the sight and reach of children.
Store below 25°C.
Do not use this veterinary medicinal product after the expiry date stated on the label. The expiry date refers to the last day of that month.
Shelf life after first opening the immediate packaging: 60 days.
Shelf life after dilution in drinking water: use immediately.

SPECIAL WARNINGS:
Special precautions for safe use in target species:
Due to variability (temporal, geographical) in bacterial susceptibility when using the product, it is recommended to collect bacteriological samples and perform susceptibility testing on microorganisms isolated from diseased animals. If this is not possible, treatment should be based on local epidemiological information (region, farm) regarding the susceptibility of the target bacteria. Use of the product deviating from the instructions in the SPC may increase the prevalence of resistance to oxytetracycline and may decrease the effectiveness of treatment due to the potential for cross-resistance. Official and local antimicrobial policies should be taken into account when using the product.
Special precautions to be taken by the person administering the veterinary medicinal product to animals:
People with known hypersensitivity to the active substance should avoid contact with the veterinary medicinal product. Avoid contact with eyes and skin. In case of accidental contact with skin or eyes, rinse with plenty of water, seek medical advice immediately and show the package leaflet or the label to the physician. Wear protective equipment ,personal protection when handling the veterinary medicinal product. Wash hands after handling the product.
Use during pregnancy, lactation and lay:
Can be used during pregnancy and lactation.
Interactions with other medicinal products or other forms of interaction:
None known.
Overdose:
The recommended doses should be followed.
Incompatibilities:
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.

SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY:
Treated animals should be kept in shelters throughout the treatment period and their excrement should be collected and not used for soil fertilisation. Medicines should not be thrown into wastewater or household waste. Ask your veterinarian for information on how to dispose of medicines no longer required. These measures help to protect the environment. Treated animals should be kept in shelters throughout the treatment period and the resulting manure should not be used for soil fertilization. Ask your veterinarian for information on how to dispose of medicines no longer required.

SIZE:
sachet x 50 g, 100 g