TERACICLIN LA 300

COMPOSITION

Active substance:

Oxytetracycline (as oxytetracycline dihydrate) 300 mg/ml

Excipients:

Sodium formaldehyde sulphoxylate                      4 mg/ml

CONTRAINDICATIONS

Do not use in case of hypersensitivity to the active substance or to any of the excipients.

ADVERSE REACTIONS

Local reactions characterized by swelling may be observed at the injection site as a result of treatment. These lesions are of a transient nature and disappear within 1-3 weeks of treatment.

DOSAGE FOR EACH SPECIES, ROUTES AND METHOD OF ADMINISTRATION

Deep intramuscular injection.

Teraciclin LA 300 can be administered at the standard dose of 20 mg oxytetracycline/kg bw for 3 to 4 days, or in a high dose of 30 mg oxytetracycline / kg bw, for the treatment of respiratory infections, with a prolonged duration of activity (activity is maintained for 5 - 6 days).

Cattle, sheep and pigs:

Standard dose: 20 mg oxytetracycline / kg bw (1 ml product /15 kg bodyweight).

High dose: 30 mg oxytetracycline / kg (1 ml product /10 kg bodyweight).

Maximum recommended dosage at one site:

Cattle: 15 ml

Pigs: 10 ml

Sheep: 5 ml

Piglets (depending on the age of the piglet, in days):

1 day: 0.2 ml

7 days: 0.3 ml

14 days: 0.4 ml

21 days: 0.5 ml

Over 21 days: 1 ml/ 10 kg

ADVICE ON CORRECT ADMINISTRATION

To ensure a correct dose, the body weight of the animals should be accurately determined, whenever possible, to avoid underdosing.

WITHDRAWAL PERIODS

Meat and offal

For the dose of 20 mg/kg bw:

Cattle and sheep: 28 days.

Pigs: 14 days.

For the dose of 30 mg/kg bw:

Cattle: 35 days.

Pigs and sheep: 28 days.

Animals will not be slaughtered for human consumption during treatment.

Milk

Cattle: 10 days.

Sheep:  8 days.

Milk for human consumption must not be taken during treatment.

SPECIAL STORAGE PRECAUTIONS

Do not store above 25^oC. Protect from light. Keep the vial in the outer package.

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 WARNINGS

Special warnings for each target species

None.

Special precautions for use

Special precautions for use in animals

Use of the 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 epidemiological (region, farm level) information about susceptibility of the target bacteria. Official, national and regional antimicrobial policies will be considered when using the product.

Use of the product deviating from the instructions in the SPC may increase the risk of development and selection of oxytetracycline-resistant bacteria and decrease the effectiveness of treatment.

Special precautions to be taken by the person administering the medicinal products to animals

People with known hypersensitivity to oxytetracycline should avoid contact with the veterinary medicinal product.

In case of accidental skin contact, wash the contact area with water and soap.

In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.

The use during pregnancy, lactation or lay

In mammals, Teraciclin LA 300 passes through the placental barrier and administration during the last period of gestation, the period of bone and tooth development, may lead to tooth coloration and delayed fetal growth.

Teraciclin LA 300 can be safely administered to lactating animals but oxytetracycline is found in milk.

During pregnancy and lactation, the product is used only according to the benefit/risk assessment by the responsible veterinarian.

Interactions with other medicinal products and other forms of interaction

None known.

Overdose (symptoms, emergency procedures, antidotes), if necessary

Overdose may cause nephrotoxicity in cattle. There is no specific treatment.

Incompatibilities

Dilution with solutions of calcium salts will cause precipitation and must be avoided.

PRESENTATION/PACKAGE

Vials of 100 ml and 250 ml.