TERACICLIN LA 30% inj

COMPOSITION

Each ml of product contains 300 mg of Oxytetracycline (as dihydrate)

TARGET SPECIES

Pigs, cattle and sheep 

INDICATIONS

In the treatment of diseases caused by Oxytetracycline-susceptible germs.

Boredetella bronchiseptica, Actinomyces pyogenes, Erysipelothrix rhusiopathiae, Pasterurella spp, Staphylococcus spp, Streptococcus spp., Mycoplasma, Rickettsiile, protozoa and almides may be susceptible to Oxytetracycline.

The product is recommended for the treatment and control of pasteurellosis, pneumonia, atrophic rhinitis, wildfire, joint infections, cows’ summer mastitis, sheep keratoconjunctivitis and enzootic abortion in sheep.

CONTRAINDICATIONS

Do not dilute this product.

ADVERSE REACTIONS

The product is well tolerated, but occasionally a local reaction occurs.

DOSAGE FOR EACH SPECIES, METHOD AND ROUTE(S) OF ADMINISTRATION

Deep intramuscular administration, single dose. The standard dose is 20 mg/kg with a duration of action of 3-4 days or a high dose, 30 mg/kg, with a longer activity period, of 5-6 days.

Cattle, sheep and pigs: Standard dose: 20 mg/kg (1 mL/15 kg)

High dose: 30 mg/kg (1 mL/10 kg) The maximum recommended dose at a single injection site;

Cattle 15 mL

Pigs 10 mL

Sheep 5 mL

Piglets 1 day: 0.2 mL

        7 days: 0.3 mL

        14 days: 0.4 mL

        21 days; 0.5 mL

After 21 days: 1 mL/10 kg

This product does not contain antimicrobial preservatives. Disinfect the septum before each puncture. Use sterile needles and syringes.

WARNINGS/ADVICE ON CORRECT ADMINISTRATION

To ensure proper dosing and to avoid underdosing, body weight should be determined as accurately as possible.

WITHDRAWAL PERIOD(S)

20 mg/kg dose meat and offal

Cattle and sheep 28 days

Pigs 14 days

30 mg/kg dose meat and offal

Cattle 35 days

Pig and sheep 28 days

Cattle (milk) 10 days

Sheep 8 days

SPECIAL PRECAUTIONS FOR STORAGE

Keep out of reach of children. Do not store above 25°C. Keep in the original package, protected from light.

SHELF LIFE

Shelf life of the veterinary medicinal product as packaged for sale: 2 years. Shelf-life after first opening the immediate packaging: 28 days.

SPECIAL PRECAUTIONS FOR USE IN ANIMALS

The use of the product should be based on antimicrobial susceptibility testing of bacteria isolated from animals. If this is not possible, therapy should be based locally on epidemiological information on the target bacteria’s susceptibility. Using the product in violation of the instructions provided in the SmPC may increase the prevalence of resistant bacteria and may decrease treatment effectiveness with other tetracyclines due to their cross-resistance potential.

SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE PRODUCT:

Do not use this product in cases of known hypersensitivity to the active substances or to any of the excipients.

To avoid self-injection, the product should be handled with caution. In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician. Wash your hands after use. In case of contact with eyes or skin, rinse immediately with water until the irritation disappears.

USE DURING PREGNANCY AND LACTATION 

In mammals, the product passes through the placental barrier, and administration during late gestation period, when the development of bones and teeth takes place, may lead to teeth colouring and delayed foetal growth.

The veterinary medicinal product may be safely administered to lactating animals but Oxytetracycline is found in breast milk.

During gestation and lactation, the product shall only be used in accordance with the benefit/risk assessment performed by the responsible vet.

INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION

No data are available.

OVERDOSE (SYMPTOMS, EMERGENCY PROCEDURES, ANTIDOTES)

Overdosing can cause neurotoxicity in cattle. There is no specific therapy.

INCOMPATIBILITIES

Dilution with solutions that have calcium salts causes precipitation, so it should be avoided.

SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS, IF ANY

Any unused veterinary medicinal product or waste materials derived from such products should be disposed of in accordance with local requirements. Medicines should not be disposed of via waste water or household waste.

PRESENTATION/PACKAGE

50 mL, 100 mL and 250 mL polypropylene vials sealed with bromobutyl rubber stopper and aluminium cap.