País: Espanha
Língua: inglês
Origem: HMA (Heads of Medicines Agencies)
amoxicillin trihydrate 400 mg, clavulanic acid potassium salt 100 mg
Laboratorios Calier
QJ01CR02
Tablet
amoxicillin and enzyme inhibitor
Dogs Non Food
2011-12-09
A. LABELLING PARTICULARS TO APPEAR ON THE OUTER PACKAGE BOX 1. NAME OF THE VETERINARY MEDICINAL PRODUCT NICILAN 400 mg /100 mg tablets for dogs 2. STATEMENT OF ACTIVE AND OTHER SUBSTANCES Each tablet contains: Active substances: Amoxicillin (as trihydrate) ................................. 400 mg Clavulanic acid (as potassium clavulanate) ... .100 mg Excipients: Erythrosine (E-127) ........................................... . 7.5mg 3. PHARMACEUTICAL FORM Tablet. 4. PACKAGE SIZE 12 tablets. 60 tablets 120 tablets 240 tablets 5. TARGET SPECIES Dogs 6. INDICATION(S) NICILAN 400 mg/100 mg tablets for dogs is indicated for the treatment of bacterial infections caused by beta-lactamase producing strains resistant to amoxicillin: infections of the respiratory tract, infections of the genitourinary tract, infections of the digestive tract and infections of the skin and soft tissues. 7. METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use. 8. WITHDRAWAL PERIOD Not applicable 9. SPECIAL WARNING(S), IF NECESSARY 10. EXPIRY DATE _ _ EXP_ _ 11. SPECIAL STORAGE CONDITIONS Store below 30°C. 12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS, IF ANY Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements . 13. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, IF APPLICABLE For animal tr Leia o documento completo
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT: NICILAN 400 mg/100 mg tablets for dogs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION: Each tablet contains: Active substances: Amoxicillin (as trihydrate) ................................. 400 mg Clavulanic acid (as potassium clavulanate) .. 100 mg Excipients: Erythrosine (E1-27) .......................................... 7.5mg For a full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM: Tablet. Uniform pink oblong divisible tablet. 4. CLINICAL PARTICULARS: 4.1. TARGET SPECIES: Dogs 4.2. INDICATIONS FOR USE, SPECIFYING TARGET SPECIES: NICILAN 400 mg/100 mg tablets for dogs is indicated for the treatment of bacterial infections caused by beta-lactamase producing strains resistant to amoxicillin. Infections of the respiratory tract Infections of the genitourinary tract Infections of the digestive tract Infections of the skin and soft tissues 4.3 . CONTRAINDICATIONS: Do not use in animals with known allergy to antibiotics of the beta-lactam group. Do not use in rabbits, guinea pigs and hamsters. 4.4. SPECIAL WARNINGS FOR EACH TARGET SPECIES 2 Adjust the dose in animals with renal disturbances. 4.5. SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS In case of any infective process, a bacteriological diagnostic confirmation is recommended, as well as a sensitivity test of the bacteria causing the process. SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY MEDICINAL PR Leia o documento completo