TSEFALEN 1000MG 104 TABLETS | ANTIBIOTIC FOR DOGS

TSEFALEN

2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains:
Active substance:
Cephalexin (as cephalexin monohydrate) 1000 mg
For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM
Film-coated tablets
Orange oblong film-coated tablets with a score line on one side. The other side is engraved with the inscription U60.
The tablets can be divided into two equal parts.

4. CLINICAL DATA
4.1 Target species
Dogs

4.2 Indications for use, specifying the target species
For the treatment of infections of the respiratory system, genitourinary system and skin, localized soft tissue infections and gastrointestinal infections caused by bacteria sensitive to cephalexin.
4.3 Contraindications
Do not use in case of hypersensitivity to the active substance or to any of the excipients.
Do not administer to rabbits, guinea pigs, hamsters or gerbils.

4.4 Special warnings for each target species
Not applicable.

4.5 Special precautions for use
Special precautions: for use in animals
Whenever possible, the use of the veterinary medicinal product should be based on antibiograms of bacteria isolated from the animal and taking into account official and local antimicrobial policies.
Use of the veterinary medicinal product in contravention of the instructions in the SmPC may increase the prevalence of bacteria resistant to cephalexin and may reduce the efficacy of treatment with other beta-lactam antibiotics, due to the potential for cross-resistance.
Do not administer in case of resistance to cephalosporin and penicillin.
As with other antibiotics excreted primarily by the kidneys, systemic accumulation may occur if there is impaired renal function. In case of renal insufficiency, the dose should be reduced and they should not be administered
concomitant nephrotoxic antibiotics.
Special precautions to be taken by the person administering the medicinal product to animals
– Penicillins and cephalosporins may cause hypersensitivity (allergy) after injection, inhalation, ingestion or skin contact. Hypersensitivity to penicillin may cause cross-reactions with cephalosporin and vice versa. Sometimes allergic reactions to these substances can be severe. Do not handle this veterinary medicinal product if you are sensitized or if you have been advised not to come into contact with these substances.
– Handle this veterinary medicinal product with great care to avoid exposure, taking all recommended precautions. If you develop symptoms after exposure, such as a skin rash, seek medical attention and show the doctor this notice. Swelling of the face, lips or eyes or respiratory distress are the most serious symptoms that require urgent medical attention.
– In case of accidental ingestion, consult a doctor immediately and show him the package leaflet or the label.
– Wash hands after use.

4.6 Adverse reactions (frequency and seriousness)
Some dogs may experience nausea and vomiting after administration.
As with other antibiotics, diarrhea may occur.

4.7 Use during pregnancy or lactation
Laboratory studies in rats and mice have not shown teratogenic, fetal-toxic, or maternally toxic effects.
The safety of the veterinary medicinal product has not been established during pregnancy or lactation. Use only according to the benefit/risk assessment carried out by the responsible veterinarian.

4.8 Interaction with other medicinal products and other forms of interaction
To ensure efficacy, the veterinary medicinal product should not be used in combination with bacteriostatic antibiotics.
The concomitant use of first-generation cephalosporins with aminoglycoside antibiotics or certain diuretics, such as furosemide, may increase the nephrotoxic risks.

4.9 Dosage and route of administration
Orally.
The recommended dose is 15 mg cephalexin per kilogram of body weight twice daily. In serious or acute conditions, the dose can be doubled to 30 mg/kg twice daily.
The following are the instructions for use of the drug:
26-50 kg of body weight. tablet twice a day
Animals with a body weight greater than 51 kg should be administered an appropriate combination of tablets according to their body weight.
The drug must be administered for a minimum period of 5 days.
– 14 days in cases of urinary tract infection.
– At least 15 days in case of superficial infectious dermatitis.
– At least 28 days in case of deep infectious dermatitis.
Any increase in dose or duration of treatment should be made in accordance with the benefit/risk assessment by the responsible veterinarian (eg chronic pyoderma).
To ensure a correct dose, body weight should be determined as accurately as possible to avoid underdosing.
The veterinary medicinal product can be given as whole tablets, or crushed and added to food if necessary.

4.10 Overdose (symptoms, emergency procedures, antidotes)
In relation to acute toxicity, an LD50 >0,5 g/kg has been reported after oral administration in dogs. Administration of several times the recommended dose of cephalexin has been shown not to produce serious side effects.

4.11 Timeout
Not applicable.

5. PHARMACOLOGICAL PROPERTIES
Pharmacotherapeutic group: other beta-lactam antibiotics. First generation cephalosporins. cephalexin
ATCvet code: QJ01DB01

5.1 Pharmacodynamic properties
Cephalexin is a broad-spectrum cephalosporanic antibiotic with bactericidal activity against a wide range of Gram-positive and Gram-negative bacteria.
Cephalexin is a broad-spectrum semisynthetic bactericidal antibiotic that belongs to the group of cephalosporins, which acts by interfering with the formation of the bacterial wall. This bactericidal activity is achieved by binding of the drug to bacterial enzymes called penicillin-binding proteins (PFPs). These enzymes are found in the inner membrane of the bacterial wall and their transpeptidase activity is necessary for the terminal phases of the formation of this essential structure of the bacterial wall. The inactivation of PFPs interferes with the necessary cross-linking of peptidoglycan chains.
to provide strength and rigidity to the bacterial wall. The bacterial effect of cephalexin is time dependent.
Cephalexin is resistant to the action of staphylococcal penicillinase and is therefore active against strains of Staphylococcus aureus that are not sensitive to penicillin (or related antibiotics such as ampicillin or amoxicillin) due to penicillinase production.
Cephalexin is also active against most ampicillin-resistant Escherichia coli bacteria.
The following microorganisms have been shown to be sensitive to cephalexin in vitro:
Corynebacterium spp, Staphylococcus spp (including penicillin-resistant strains), Streptococcus spp, Escherichia coli, Moraxella spp, Pasteurella multocida.
MIC data collected for cephalexin in canine isolates from the European Union (EU) (Stegmann et al. 2006)
Bacterial species/group and origin No. of isolates CMI50 CMI90
Staphylococcus pseudintermedius (EU) 270 1 2
Staphylococcus aureus (EU) 36 2 8
Coagulase-negative staphylococci (EU) 21 1 8
Coagulase-positive staphylococci (EU) 24 1 2
Beta-hemolytic staphylococci (EU) 86 more than 0,5 2
Enterococcus spp. (EU) 331 over 64 over 64
Pasteurella multocida (EU) 193 4 4
Escherichia coli (EU) 260 8 16
Proteus spp. (EU) 71 16 16
Klebsiella spp. (EU) 11 4 4
Enterobacter spp. (EU) 39 8 over 64
The three basic mechanisms of cephalosporin resistance are the result of decreased permeability, enzyme inactivation, or the absence of specific penicillin-binding proteins.

5.2 Pharmacokinetic data
Cephalexin is rapidly and almost completely absorbed from the gastrointestinal tract after oral administration. Cephalexin binds to a limited extent (10-20%) to plasma proteins. Following oral administration of 15 mg/kg tablets, the maximum concentration in the blood (Cmax=15 ƒÊg/ml) is usually reached within 1 to 2 hours (Tmax=90
minutes).
Bioavailability is almost 100% of the administered dose (AUC 6279 ƒÊg min/mL). Cephalexin does not undergo biotransformation processes of pharmacokinetic significance.
The elimination half-life of cephalexin is about 1,5 hours (t1/2 = 90 minutes).
Elimination of the microbiologically active form is almost entirely via the kidneys, via tubular excretion and glomerular filtration.

6. PHARMACEUTICAL DATA
6.1 List of excipients
Titanium dioxide (E171)
Ferric oxide yellow (E172)
Red iron oxide (E172).
Povidone
Sodium starch glycolate, type A
Magnesium stearate
Glycerol
Talc
hypromellose

6.2 Incompatibilities
None known.

6.3 Period of validity
Shelf life of the veterinary medicinal product packaged for sale: 3 years.
Shelf-life after breaking the tablet in half: 48 hours

6.4 Special precautions for storage
This veterinary medicinal product does not require special storage conditions.
Return the compressed media to the blister pack.

6.5 Nature and composition of immediate packaging
Cardboard box containing 1 PVC/aluminium blister with 8 tablets
Cardboard box containing 13 PVC/aluminium blisters with 8 tablets, for a total of 104 tablets.
Not all formats may be marketed.

See technical sheet