Clortetradem 50

CLORTETRADEM 50 500 mg chlortetracycline hydrochloride /g water-soluble powder, for pigs and poultry (broilers, breeding birds, replacement young, laying hens for consumption).

1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER SC DELOS IMPEX ’96 SRL, Str. Horia, Cloşca şi Crişan, no. 81, Otopeni, Ilfov County;

2. NAME OF THE VETERINARY MEDICINAL PRODUCT CLORTETRADEM 50, 500 mg chlortetracycline hydrochloride /gram water-soluble powder, for pigs and poultry (broilers, breeding birds, replacement young, laying hens for consumption). Chlortetracycline hydrochloride

3. STATEMENT OF ACTIVE AND OTHER SUBSTANCES CLORTETRADEM 50 is a yellow powder containing per 1 gram: Chlortetracycline hydrochloride ………… 500 mg (equivalent to 463 mg chlortetracycline base)
Excipient (lactose monohydrate) qs.ad.………………..…..………..………. 1 g

4. INDICATIONS
Chlortetradem 50 is mainly indicated in the treatment of respiratory infections caused by bacteria of the genera Clostridium, Pneumococcus, Streptococcus, Haemophillus influenzae, Klebsiella pneumoniae. In pigs, CLORTETRADEM 50 is also indicated for use in the treatment of infections caused by some species of sensitive bacteria from the genera: Corynebacterium, Erysipelothrix, Listeria, Actinobacillus, Bordetella, Francisella, Haemophillus, Pasteurella, Manhaemia, Campylobacter, Leptospira, Actinomyces, Mycoplasma, Chlamydia, Rickettsia. In birds (broiler chickens, breeding birds, replacement young, egg hens for consumption) CLORTETRADEM 50 is indicated for the treatment of infections caused by some species of sensitive bacteria from the genera: Clostridium, Corynebacterium, Erysipelothrix, Listeria, Streptococcus, Actinobacillus, Bordetella, Francisella, Haemophillus, Pasteurella, Campylobacter, Borellia, Leptospira, Actinomyces, Mycoplasma, Chlamydia, Rickettsia and Anaplasma spp.

5. CONTRAINDICATIONS
Do not administer to animals with known hypersensitivity to tetracyclines.

6. ADVERSE REACTIONS
Sometimes, in animals with severe renal insufficiency, adverse reactions may occur, manifested by: anorexia, vomiting, abdominal colic, diarrhea, painful defecation. Possible toxic phenomena are due to high concentrations of chlortetracycline in the blood and tissues that occur after the administration of too high doses, repeated at shorter intervals than those recommended in the package leaflet or in case of severe renal insufficiency. Digestive system: anorexia, vomiting, diarrhea, abdominal colic, pancreatitis; Chlortetradem 50 administered for a long time may lead to the appearance of staphylococcal enteritis or candidiasis (oral, intestinal, pulmonary). Teeth: dental pigmentation, caries, dental enamel hypoplasia in newborns and infants whose mothers received chlortetracycline during gestation or after calving, as well as in youth.

7. TARGET SPECIES
Pigs, poultry (broilers, breeding birds, replacement young, laying hens).

8. DOSAGE, METHOD AND ROUTE OF ADMINISTRATION
In poultry (broilers, breeding birds, replacement young, laying hens) it is administered orally, at a dose of 20-50 mg chlortetracycline base/kg body weight/day (21.60 – 54 mg chlortetracycline hydrochloride/kg body weight/day, i.e. approximately 44 – 108 mg Clortetradem 50 /kg body weight/day) for 3-5 consecutive days. In pigs: the therapeutic dose is 40 mg chlortetracycline base/kg body weight/day (43.2 mg chlortetracycline hydrochloride/kg body weight/day, i.e. approximately 87 mg Clortetradem 50 /kg body weight/day) for 3-5 consecutive days. The following calculation formula can be used for administration: In drinking water: mg Chlortetradem 50/ kg live weight/day x average body weight of animals to be treated (kg) = mg Chlortetradem 50 / liter of water Average daily water consumption (liters) / animal In feed: mg Chlortetradem 50/ kg live weight/day x average body weight of animals to be treated (kg) = mg Chlortetradem 50 / kg feed Average daily feed consumption (kg) / animal Ingestion of water or feed is dependent on the clinical conditions of the animals. Therefore, in order to obtain the correct dosage, the concentration in drinking water or feed will have to be adjusted.

9. RECOMMENDATIONS ON CORRECT ADMINISTRATION
It is recommended that treatments be initiated after performing an antibiogram. If this is not possible, treatment should be carried out based on local epidemiological information (region, farm). During the entire treatment period, animals should drink only medicated water and eat only medicated feed. Fresh medicated water should be prepared every 24 hours. To ensure proper dosing, the body weight of the animals should be calculated as accurately as possible to avoid underdosing the product. The product should be thoroughly mixed with the concentrated feed to ensure uniform dispersion throughout the feed.

10. WITHDRAWAL PERIOD
For pork: 7 days from the last administration. For poultry: 3 days from the last administration. For eggs: 3 days from the last administration.

11. SPECIAL STORAGE PRECAUTIONS
Keep out of reach of children! Store in the original packaging, at room temperature (15 – 25oC), away from moisture and direct sunlight. After first opening the packaging: the product should be used immediately. The medicated water has a shelf life of 24 hours from the date of preparation. The medicated feed has a shelf life of 3 months from the date of mixing. Do not use after the expiry date stated on the label.

12. SPECIAL WARNINGS
People with known hypersensitivity to tetracyclines or to the excipient of the product should avoid contact with the product. In order to prevent any unpleasant effects, it is recommended to wear gloves, safety glasses and dust masks when handling the product. In case of accidental ingestion of the product or if symptoms of skin itching or irritation occur, seek medical advice immediately and show the package leaflet or the label to the physician. Serious symptoms such as swelling of the face, lips or eyelids with difficulty breathing require urgent medical attention.

13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS, IF ANY
In order to protect the environment, the product should not be disposed of via wastewater or household waste but in designated areas. Any unused veterinary medicinal product or waste materials derived from the use of such products should be disposed of in accordance with local requirements. Treated animals should be kept in shelters throughout the treatment period and collected manure should not be used for soil fertilization.

14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED July 2011.
15. OTHER INFORMATION Presentation: Heat-sealed PET bags with aluminium insert containing 10g, 25g, 50g, 100g, 500g, 1000g, 5kg, 10kg and PET bags with aluminium insert of 25kg, 50kg.
Not all pack sizes may be marketed.