Rilexine chewable 75mg 14 tablets | bacterial infections

RILEXINE 

2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:

3. PHARMACEUTICAL FORM
Chewable pills.

Composition: per tablet:
Rilexine 75: Cephalexin (monohydrate) 75 mg.
Rilexine 300: Cephalexin (monohydrate) 300 mg.
Rilexine 600: Cephalexin (monohydrate) 600 mg.

4. CLINICAL DATA
4.1 Target species
Dogs.
4.2.- Indications for use, specifying the target species
Dogs:
- Treatment of bacterial skin infections in dogs caused by microorganisms sensitive to cephalexin.
- Treatment of urinary tract infections caused by microorganisms sensitive to cephalexin.
4.3.- Contraindications
Do not administer to animals with a history of hypersensitivity to cephalosporins and other beta-lactams.
Do not administer to animals with severe renal insufficiency.
Do not use in rabbits, guinea pigs, hamsters, and gerbils.
4.4 Special warnings for each target species
They have not been described
4.5.- Special precautions for use

Special precautions for use in animals
As with other antibiotics that are mainly excreted by the kidneys, accumulation in the body may occur when renal function is impaired. In case of known renal insufficiency, the dose should be reduced and nephrotoxic antibiotics should be avoided.
This medication should not be used in puppies weighing less than 1 kg. This medication should be used, whenever possible, after bacteriological confirmation of the diagnosis and a sensitivity test of the bacteria causing the process.
The use of this medication in conditions other than the instructions described in its SmPC may increase the prevalence of bacteria resistant to cephalexin and decrease the efficacy of treatment with other cephalosporins and penicillins due to their potential cross-resistance.

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 cross-react with cephalosporin and vice versa. Allergic reactions to these substances can sometimes be severe. Do not handle the medication if you are allergic to penicillins and/or cephalosporins. Wash hands after use. In case of accidental ingestion, consult a doctor immediately and show him the text of the container or the leaflet.
If after exposure you develop symptoms such as a skin rash, see a doctor and show him this warning. Swelling of the face, lips or eyes or shortness of breath are more serious symptoms that require urgent medical attention. Do not smoke, eat or drink while handling the medicine.

4.6.- Adverse reactions (frequency and severity)
Vomiting and diarrhea may occasionally appear.

4.7 Use during pregnancy, lactation or lay
The safety of the veterinary medicinal product has not been established during pregnancy or lactation in the target species.
Use only in accordance with the benefit/risk assessment carried out by the responsible veterinarian.
Laboratory studies have not shown teratogenic effects.

4.8 Interaction with other medicinal products and other forms of interaction
Do not administer with potentially nephrotoxic drugs or bacteriostatic antibacterials.
4.9. Dosage and route of administration
Administer orally at a rate of 15 mg of cephalexin/kg bw/12 h, equivalent to 1 tablet / 20 kg bw / 12 hours during:
- 14 days in case of urinary tract infections
- at least 15 days in superficial infectious dermatitis
- at least 28 days in cases of deep infectious dermatitis.
To ensure correct dosing, the animal's weight should be determined as accurately as possible to avoid under-dosing.
Due to the appetizing formulation, the medicine is well accepted by dogs but if necessary it should be crushed or added to the food.
The dose can be doubled in severe or acute conditions.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
Tests carried out on animals that were administered up to 5 times the recommended dose of 15 mg/kg showed the good tolerance of the drug.
4.11 Timeout
Not applicable.
5.- PHARMACOLOGICAL PROPERTIES
Pharmacotherapeutic group: Antibacterials for systemic use. First generation cephalosporins.
ATCvet code QJ01DB01
5.1 Pharmacodynamic properties
Cephalexin acts by inhibiting the nucleopeptide synthesis of the bacterial wall. Cephalosporins interfere with transpeptidation by acylating the enzyme and preventing the binding of the muramic acid cross-bridges contained in the peptidoglycan chains. The inhibition of the biosynthesis of the material necessary for the construction of the cell wall gives
as a result a defective cell wall and consequently osmotically unstable. The combined action causes cell lysis.
Cephalexin is active against Staphylococcus spp (including penicillin-resistant strains), Streptococcus spp, Escherichia coli, Klebsiella spp, Salmonella spp and Pasteurella multocida. Cephalexin is not inactivated by beta-lactamases produced by Gram-positive bacteria, which generally affects penicillins.

Cephalexin resistance may be due to one of the following mechanisms. Firstly, the production of various beta-lactamases (cephalosporinases), which inactivate the antibiotic, this being the most common mechanism. frecuente among Gram negative bacteria. Second, a decrease in the affinity of PBPs (penicillin-binding proteins) for the
beta-lactams that is common among Gram-positive bacteria resistant to beta-lactams. Finally, the excretion pumps that expel the antibiotic from the cell wall, and the structural changes of the pores, which reduce the passive diffusion of the cephalosporin through the cell wall, can contribute to increase the resistance phenotype of a bacterium. There is cross-resistance between antibiotics of the beta-lactam group, due to structural similarities, such as in the case of beta-lactamase production, structural changes in the pores or variations in the excretion pumps. Co-resistance phenomena have been described in E.coli due to plasmids with several genes of
endurance.

6. PHARMACEUTICAL DATA
6.1 List of excipients
Crospovidone, Pharmaburst B1 (mannitol, pregelatinized starch, crospovidone, croscarmellose sodium, and colloidal silica)
Povidone, Microcrystalline Cellulose, Type A, Poultry Flavor Powder, Magnesium Stearate, Microcrystalline Cellulose, Type B
6.2 Incompatibilities
They have not been described.

6.3 Validity period
Shelf life of the veterinary medicinal product packaged for sale: 3 years.
6.4. Special storage precautions
Store in the original packaging in order to protect from light and moisture.
6.5 Nature and composition of immediate packaging
The tablets are packed in blister packs consisting of a cold-formed composite aluminum strip and a heat-sealed aluminum foil.
1 Box containing 2 blister packs of 7 tablets (14 tablets).
1 Box containing 20 blister packs of 7 tablets (140 tablets).6.6 Special precautions for disposal of unused veterinary medicinal product or, where appropriate, residues derived from its use
All unused veterinary medicine or residues derived from it must be disposed of in accordance with current regulations.
7. MARKETING AUTHORIZATION HOLDER
VIRBAC SA – 1ère avenue – 2065 m LID – 06516 CARROS – FRANCE
8. MARKETING AUTHORIZATION NUMBER
2178 ESP
9. DATE OF THE FIRST AUTHORIZATION OR RENEWAL OF THE
AUTHORIZATION
July 23, 2010
10. DATE OF REVISION OF THE TEXT
July 23, 2010

Data sheet