CLORTETRADEM 10% PREMIX

Medicated premix

CLORTETRADEM 10% PREMIX,
premix for medicated feed, 100 mg/g chlortetracycline HCl,
for pigs and poultry (chickens, turkeys).

1. STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTS
1 gram CLORTETRADEM 10% PREMIX contains:
Chlortetracycline HCl………………………………………………..……… 100 mg
Excipient (corn starch) qs ad. ………………………………………….……. 1 g

2. INDICATIONS
In pigs: CLORTETRADEM 10% premix is indicated for treatment and control of respiratory and systemic infections associated with organisms chlortetracycline-susceptible: Haemophillus parasuis, Corynebacterium, Erysipelothrix rhusiopatiae, Streptococcus hyicus, Actinobacillus pleuropneumoniae, Pasteurella multocida, Mycoplasma spp. etc.
In poultry (chickens, turkeys): CLORTETRADEM 10% premix is indicated for treatment and control of respiratory and systemic infections associated with organisms sensitive to chlortetracycline-susceptible: Streptococcus spp., Bordetella bronchiseptica, Haemophillus paragallinarum, Pasteurella multocida, Fusobacterium, Mycoplasma, Chlamydia, etc.

3. CONTRAINDICATIONS
Do not use in animals with known hypersensitivity to tetracyclines.

4. ADVERSE REACTIONS
In some cases, the animal with severe renal failure could develop adverse reactions characterized by: anorexia, vomit, diarrhea, abdominal colic, painful defecation.
The possible toxic phenomena are due to chlortetracycline high concentrations in blood and tissues, which occur after the administration of multiple high doses and in low intervals or in case of severe renal failure.
Digestive apparatus: anorexia, vomits, diarrhea, abdominal colic and pancreatitis; administered for long periods of time can produce staphylococcal enteritis or candidosis (oral, intestinal, pulmonary).
Teeth: dental pigmentation, caries and dental enamel hypoplasia in suckling and young off-springs to who mothers were treated with CLORTETRADEM 10% premix in the latest period of gestation or after birth.

7. TARGET SPECIES
Pigs and poultry (chickens, turkeys).

8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
CLORTETRADEM 10% premix is administered via drinking water in the following dosages:
Pigs: 110 mg CLORTETRADEM 10% premix /kg b.w./day administered for 5 consecutive days.
Poultry (chickens, turkeys): 110 mg CLORTETRADEM 10% premix /kg b.w./day, administered for 5 consecutive days.

Based on the recommended doses and the number and weight of the animals to be treated, the exact daily amount of CLORTETRADEM 10% PREMIX included in feed should be calculated according to the following formula:

mg CLORTETRADEM 10% premix / kg body weight/day x mean body weight of animals to be treated (kg)

=

mg CLORTETRADEM 10% premix / kg of feed

Mean daily feed consumption (kg) / animal

 

10. WITHDRAWAL PERIODDuring treatment, the animals should eat only medicated feed. To ensure a correct dosage, body weight should be determined as accurately as possible to avoid underdosing.
9. ADVICE ON CORRECT ADMINISTRATIONThe uptake of medicated feed is dependant on the clinical condition of animals. In order to obtain the correct dosage, the concentration in feed may have to be adjusted.
The use of suitable calibrating weighing equipment is recommended if part packs are used.

Pigs, poultry (chickens, turkeys):
Edible tissues: 28 days after cessation of oral medication.
For eggs: 7 days after cessation of oral medication

11. SPECIAL PRECAUTIONS FOR STORAGE
Keep away from reach and sight of children!
Store in original packaging at temperatures below 25oC, protected from moisture and direct sunlight.
Shelf life of the veterinary medicinal product as packaged for sale: 2 years.
Shelf life after dilution in drinking water, according to directions: 24 hours.
Shelf life after first opening of the package: 7 days.
Shelf life after incorporation into meal: 7 days
Do not use after expiry date which is stated on the label.