1.NAME AND ADDRESS OF THE MANUFACTURNG AUTHORISATION HOLDER AND MANUFACTURER RESPOSNBLE FOR BATCH RELEASE, IF DIFFERENT
Manufacturing authorisation holder and manufacturer:
Biofaktor Sp z o.o.
Czysta 4 st.
2. NAME OF THE VETERINARY MEDICINAL PRODUCT
Tarcefal 250 coated tablets for dogs
3. QUALITATIVE AND QUANTITATIVE COMPOSITION OF ACTIVE SUBSTANCES
1 tablet contains:
Cephalexin monoydrate 250 mg
Antibiotic for oral administration for dogs and cats in infections caused by microorganisms sensitive to cephalexin.
Dogs: superficial and deep purulent skin inflammations, urinary tract infections
Do not administer to animals with known hypersensitivity to cephalosporins and penicilins or excipients contained in the tablet.
In animals with known renal failure, the frequency of drug usage shall be lowered by two.
In those patients, do not use cephalexin togeher with drugs with known nephrotoxicity such as aminoglycosides and amphotericin B.
6. ADVERSE EFFECTS
Occasionally in some animals side effects such as vomiting, diarrhea, drooling affecting the digestive system may occur. Sometimes there may appear skin reactions. After administration of cephalexin occasionally there were reports on incidence of erythema multiforme / pemphigus leaf. The risk when using cephalexin is however small.
The occurrence of adverse events after administration of the product or observing any adverse effects not listed in this leaflet (including symptoms in humans due to contact with the drug), you must notify the competent veterinary surgeon, manufacturing authorisation holder or the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products. The application form should be downloaded from the website http://www.urpl.gov.pl (Faculty of Veterinary Medicinal Products).
7. TARGET SPECIES
8. DOSING AND ADMINISTRATION ROUTE
Dogs: 25 mg/kg b.w. orally every 12 hours
1 tablet per 10 kg b.w. every 12 hours
Treatment period depends on the patient state:
In case of deep purulent skin inflammations, treatment period mey last from few to up to 6-8 weeks. In skin infections caused by G microorganisms, frequency of administration may be increased to 3 times daily. Antbiotic may be also used in weekend therapy in case of recurrent purulent skin inflammations (administered for 2-3 days per week).
Superficial skin inflammations require generally up to three weeks of treatment
Treatment of acute, not complicated bacterial infections of urinary tract shall last fro 10 to 14 days.
In each case about the period of therapy and frequency of drug administration decides veterinary doctor.
Because in dogs and cats the feed does not affect absorption of cephalexin, in case of inability to administer the drug deeply into the mouth by placing the tablet on tongue root, it is possible to administer the tablets with feed, or by crushing the tablet and mixing it with small amount of tasty feed. Crushing of tablets have no effect on stability of cephalexin in the digestive tract.
9. RECOMMENDATIONS FOR PROPER USE
10. WITHDRAWAL PERIOD
11. SPECIAL PRECAUTIONS DURING STORAGE AND TRANSPORT
Keep out of reach and sight of children.
Store below 25° C.
Store in original packaging in order to protect from humidity.
Contents of opened packaging must be used within 6 months.
Nie używać po upływie terminu ważności podanego na etykiecie.
Do not use after expiry period stated on the label.
12. SPECIAL WARNINGS AND PRECAUTIONS IF NECESSARY
In some animals dysfunctions of the digestive system such as vomiting or excessive salivation may occur ocassinally. They may be easy to avoid by administerig the drug with food.
In patients with known renal impairment, the frequency of administration of the antibiotic must be reduced to only once daily at a recommended dose.
In cases of chronic purulent skin inflammations, previously treated with antibiotics, or in case of finding in imprint specimen G - microorganisms, the antibiotic should be used after susceptibility study of isolated bacteria.
If an allergic reaction occurs, stop using the drug and start treatment appropriate to the hypersensitivity reaction.
Cephalexin may cause allergic reactions in people allergic to cephalosporins and penicillins after ingestion of the product or contact with the skin. Wash your hands after administration of the drug to an animal. People who are allergic should take caution when administering the drug, and in case of a rash or more serious symptoms, one should immediately contact a doctor.
Preparation may be used during pregnancy and lactation.
Cephalosporins exhibit synergistic action to aminoglycosides, penicillins and chloramphenicol. Administration of cephalexin together with aminoglycosides and other potentially nephrotoxic drugs (such as amphotericin B) should be made with caution, as it may increase their harmful effects. Therefore, it is not recommended to use these drugs simultaneously in patients with diagnosed renal failure.
Cephalexin has low acute toxicity . In dogs and cats, there were no deaths after use of cephalexin in a single dose of 500 to 1000 mg / kg b.w. Testing of higher doses was prevented due to vomiting occurring in both animal species. Multiple dose studies in a very high doses, indicate that the most common symptoms after oral administration include vomiting and drooling, there also may occur: neutropenia, neurotoxicity , agranulocytosis , hepatitis, renal toxicity (doses greater than 400 mg / kg b.w. in dogs). In cats cephalexin after oral administration at doses higher than 50 mg / kg b.w administered two times a day , may cause vomiting, salivation or diarrhea. Higher doses may be given only for a short time without symptoms of intolerance.
13. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED PRODUCT OR ITS WASTE MATERIALS, IF ANY
Medicines should not be disposed off via wastewater or household waste. About ways of disposal of medicines as your veterinarian, this will help to protect the environment.
14. DATE OF APPROVAL OR LAST CHANGE OF TEXT OF LEAFLET :
15. OTHER INFORMATION
In order to obtain information on the below vterinary medicinal product, contact the manufacturing authorisation holder.
HDPE bottles with LDPE closure with guearantee-secure lock, containing 50 or 100 tablets, individually packed in cardboard boxes.