Doxi 500

STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTS
1 g contains:
Active ingredients: doxycycline (as doxycycline hyclate) mg 500
Excipients: q. s. to g 1,00
PHARMACEUTICAL FORM
Oral powder to administer diluted in drinking water. Soluble powder of yellow colour.
PACKAGING
50 g envelop
1 kg can
TARGET SPECIES
Swine, broiler chickens and turkeys (excluding animals producing eggs for human food consumption).
INDICATIONS
Broiler chickens and turkeys: chronic respiratory disease and other respiratory illnesses, specially sustained by Pasteurella spp., Mycoplasma spp., Haemophilus gallinarum, Bordetella avium and Chlamydia psittaci.
Swine: atrophic rhinitis and respiratory illnesses specially sustained by Actinobacillus spp., Bordetella bronchiseptica, Mycoplasma spp., Pasteurella multocida, Streptococcus suis.
DOSAGE AND METHOD OF ADMINISTRATION
Broiler chickens: 4,0 g of product/100 kg b.w. (20 mg of doxycycline/kg b.w.), corresponding to about 15-30g of product/100 litres of water for 3-5 days.
Turkeys: 4,0 g of product/100 kg b.w. (20 mg of doxycycline/kg b.w.), corresponding to about 20-40 g of product/100 litres of water for 3-5 days.
Swine: 2,0 g of product/100 kg b.w. (equal to 10 mg of doxycycline/kg b.w.), for 3-5 days.
It is recommended to split the dose in two daily administrations.

Prescribed dose: Determine the weights of the animals to be treated as accurately as possible, in order to avoid any underdosage.
WITHDRAWAL PERIOD
Broiler chickens: Meat and viscera 6 days.
Turkeys: Meat and viscera 8 days.
Swine: Meat and viscera 5 days.
Do not administer to animals producing eggs for human food consumption.
SPECIAL WARNINGS
Special warnings for each target species:
The ingestion of medication by the animal may be altered due to the illness.
The repeated or long-lasting use of the products must be avoided, by improving the management practice and
through cleaning and disinfection.

Doxiciclina 50% - Chemifarma 12.M.01

Special precautions for use in animal:

• Use only after having ascertained the sensitivity of the germs to the active principle.
• It is recommended to make an antibiogram before starting the treatment.
• Any use of the product not in compliance with the instructions reported in the label might increase the prevalence of bacteria being resistant to doxycycline and might negatively affect its efficacy.
• Do not use in solid feed. Do not leave the medicated water within reach of animals not in therapy or of wild animals.

Special precautions to be taken by the person administering the product to animals:

• It is advisable to avoid direct contact with skin and eyes while handling the product; operators must therefore use protective gloves to handle the product: protective clothes, gloves and respirator which is compliant with
• the European Standard EN 149 or a non-disposable respirator compliant with the European Standard EN 140 with filter EN 143. In case of accidental contamination wash thoroughly with soap and water.
• In case of accidental ingestion, seek medical advice immediately and show the label.
• People with known hypersensitivity to doxycycline or tetracyclines or to any of the excipients must avoid any contact with the veterinary medicine.
• Do not eat, drink or smoke while handling the product.

Use during pregnancy and lactation:
The use is not recommended during pregnancy, lactation or eggs production.
Interactions with other drugs and other forms of interaction:

• Do not use together with bactericidal antibiotics such as penicillins, aminoglycosides and the like.
• The absorption of doxycycline may decrease in presence of high amounts of calcium, iron, magnesium and aluminium in the diet. Do not administer the product together with antacids, kaolin and iron-based preparations.
• It is recommended to observe an interval, which should be 1-2 hours, between the administration of other veterinary medicines containing polyvalent cations, as these diminish the absorption of the tetracyclines.
• Doxycycline increases the action of the anticoagulants.
• The solubility of the veterinary medicine depends on the pH and precipites if mixed with alkaline solutions.
• Do not store the drinking water in metal containers.

Overdose:
Data not available.
Do not exceed the recommended doses.
Incompatibility: In absence of compatibility studies available, do not mix it with other veterinary medicines.
Contraindications
The medicine should not be administered to subjects with known hypersensitivity to tetracyclines or with hepatic impairment, in patients with kidney disease should be administered under the direct supervision of the veterinarian. Do not use if tetracycline resistance was detected in the farm, due to the potential for cross-resistance.

Undesired effects: Photosensitisation. Allergic reactions. In case of long-lasting treatment, changes to the digestive tract due to intestinal disbiosis with digestive disorders may occur, also with soft faeces and diarrhoea.
If the animal shows serious adverse reaction or other reaction not included in this label, please inform the veterinary surgeon.

Doxiciclina 50% - Chemifarma 12.M.01

EXPIRY DATE: month/year
After first opening the product must be used immediately and not stored.
Validity period of the medicated liquid feed: 12 hours.
SPECIAL STORAGE PRECAUTIONS
Keep away from light in the closed package.
OTHER INFORMATION
Pharmacological properties.
Pharmacotherapeutic group: Antibacterials for systemic use, tetracyclines.
ATC: QJ01AA02

Pharmacodynamic properties:Tetracyclines are bacteriostatic antibiotics that act by binding with the sub- unit 30-S ribosomal. This bond prevents the entry of t-RNA causing the termination of protein synthesis.

Their spectrum of action includes bacteria such as: Pasteurella spp., Escherichia coli and Salmonella spp., Staphylococcus aureus, Streptococcus spp., Clostridium spp., Mycoplasma spp., other microorganisms such as Rickettsiae, Chlamydiae, and some protozoa.
The MIC values reported for strains of microorganisms sensitive to doxycycline are in the range: Pasteurella multocida 0.25-2 mg / ml; Bordetella avium 0125-2 mg / ml; Mycoplasma gallisepticum 0125-1 mg / ml;
Mycoplasma synoviae 0.25-2 mg / ml; Clostridium perfringens 0.50-4 mg / ml; Staphylococcus aureus 2-8mg / ml.
Pharmacokinetic properties:
Doxycycline is rapidly absorbed from the gastro-intestinal tract of birds due to higher lipid solubility compared to other tetracyclines. The high lipid solubility of doxycycline allows a higher concentration in all organs and tissues and a greater reabsorption in the renal tubules. The concentration in the blood lasts for 18-24 hours. It is primarily excreted in the feces.
The main pharmacokinetic parameters in poultry are: Cmax 3.913±823 ng/ml; Tmax 5,0±1,67 h; AUC 49.380±10.230 ng h/ml.
Swine: Cmax 800±320 ng/ml; Tmax 4,25±0,96 h; T1⁄2 5,9±1,0 h; AUC 49.380±10.230 ng h/ml.
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED VETERINARY MEDICINAL PRODUCT OR WASTE MATERIALS DERIVED FROM THE USE OF SUCH PRODUCTS
All unused veterinary medicines or wastes derived from such medicines must be disposed of in compliance with the local regulations.
ONLY FOR VETERINARY USE.