Valsts: Izraēla
Valoda: angļu
Klimata pārmaiņas: Ministry of Health
AMOXICILLIN AS TRIHYDRATE; CLAVULANIC ACID AS POTASSIUM
ZOETIS ISRAEL HOLDING B.V., ISRAEL
J01CA04
TABLETS
AMOXICILLIN AS TRIHYDRATE 40 MG; CLAVULANIC ACID AS POTASSIUM 10 MG
PER OS
Required
HAUPT PHARMA LATINA S.R.L, ITALY
AMOXICILLIN
For the treatment of diseases, due to susceptible microorganisms including skin diseases, urinary tract infections, respiratory diseases, enteritis, soft tissue infections, dental infection in dogs and cats.
2020-12-31
VETERINARY MEDICINE PACKAGE LEAFLET This medicine is dispensed with a veterinarian’s prescription only For animal use only 1. NAME, FORM AND STRENGTH OF THE VETERINARY MEDICINE Synulox 50 mg Veterinary, tablets Synulox 250 mg Veterinary, tablets Synulox 500 mg Veterinary, tablets 2. ACTIVE INGREDIENTS Each Synulox 50 mg Veterinary tablet contains: Amoxicillin 40 mg Clavulanic acid 10 mg Each Synulox 250 mg Veterinary tablet contains: Amoxicillin 200 mg Clavulanic acid 50 mg Each Synulox 500 mg Veterinary tablet contains: Amoxicillin 400 mg Clavulanic acid 100 mg Each tablet contains clavulanic acid in the form of potassium clavulanate and amoxicillin in the form of amoxicillin trihydrate in a palatable base. For the list of inactive ingredients, see section 13. 3. WHAT IS THE MEDICINE INTENDED FOR? For the treatment of diseases, due to susceptible microorganisms, including skin diseases, urinary tract infections, respiratory diseases, enteritis, soft tissue infections, dental infections in dogs and cats. SYNULOX VETERINARY is active in vitro against a wide range of aerobic and anaerobic bacteria, including: Gram-positive: Staphylococci (including β -lactamase - producing strains) ; Clostridia; Actinomyces; Peptostreptococcus spp; Streptococci; Enterococci. Gram-negative: Bacteroides spp. (including β -lactamase - producing strains) ; Escherichia coli (including β -lactamase - producing strains) ; Salmonellae (including β -lactamase - producing strains) ; Bordetella bronchiseptica; Campylobacter spp; Fusobacterium necrophorum; Klebsiellae; Pasteurellae; Proteus spp . Therapeutic group: antibiotic preparation from the penicillin group ATCVET CODE: QJ01CR02 4. CONTRAINDICATIONS As with other penicillins, Synulox Veterinary should not be administered orally to rabbits, guinea pigs, hamsters or gerbils. Caution is advised when administering the preparation to other small herbivores. 5. SIDE EFFECTS Very rarely hypersensitivity reactions (allergic skin reactions, anaphylaxis) may occasionally occur. If an allergi Izlasiet visu dokumentu
Synulox Tablets LPD CC 14.03.2022 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Synulox 50 mg Veterinary Synulox 250 mg Veterinary Synulox 500 mg Veterinary 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _Active ingredients:_ mg per 50 mg tablet mg per 250 mg tablet mg per 500 mg tablet Amoxicillin 40.0 200 400 (as Amoxicillin Trihydrate) 45.9 229.5 460 Clavulanic acid 10.0 50 100 (as Potassium Clavulanate) 11.9 59.5 119.2 For the full list of all other excipients see section 6.1. 3. PHARMACEUTICAL FORM Synulox Veterinary are presented as circular, pink TABLETS with a break line on one face and “Synulox” engraved on the other. Each tablet contains clavulanic acid as potassium clavulanate and amoxicillin as Amoxicillin Trihydrate. in a palatable base. 4. CLINICAL PARTICULARS 4.1. TARGET SPECIES Synulox 50 mg Veterinary - cats and dogs. Synulox 250 mg Veterinary - cats and dogs. Synulox 500 mg Veterinary – dogs only. 4.2. INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the treatment of diseases, due to susceptible microorganisms including skin diseases, urinary tract infections, respiratory diseases, enteritis, soft tissue infections, dental infection in dogs and cats. 4.3. CONTRAINDICATIONS The product should not be given to rabbits, guinea pigs, hamsters or gerbils. Caution is advised in their use in any other very small herbivores. 4.4. SPECIAL WARNINGS FOR EACH TARGET SPECIES None. SPECIAL PRECAUTIONS FOR USE i) Special precautions for use in animals Do not use this product on animals known to be sensitive to penicillin. Inappropriate use of the product may increase the prevalence of bacteria resistant to amoxicillin/clavulanic acid. In animals with hepatic and renal failure, the dosing regimen should be carefully evaluated. Synulox Tablets LPD CC 14.03.2022 Use of the product should be based on susceptibility testing and take into account official and local antimicrobial policies. Narrow spectrum antibacterial therapy should be used for first line treatment where susc Izlasiet visu dokumentu