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Nisamox Tablets are indicated for treatment of the following infections caused by ß-lactamase producing strains of bacteria sensitive to amoxicillin in combination with clavulanic acid:
•Skin infections (including superficial and deep pyodermas) caused by susceptible Staphylococci.
•Urinary tract infections caused by susceptible Staphylococci or Escherichia coli.
•Respiratory infections caused by susceptible Staphylococci.
•Enteritis caused by susceptible Escherichia coli.
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Presentation
Nisamox Tablets are for oral administration to dogs in two strengths of 50 mg and 250 mg. Each Nisamox Tablet 50 mg contains Amoxicillin 40 mg (as Amoxicillin Trihydrate Ph.Eur.) and Clavulanic Acid 10 mg (as Potassium Clavulanate Ph.Eur.). Each Nisamox Tablet 250 mg contains Amoxicillin 200 mg (as Amoxicillin Trihydrate Ph.Eur.) and Clavulanic Acid 50 mg (as Potassium Clavulanate Ph.Eur.).
Uses
Nisamox Tablets have a notably broad spectrum of bactericidal activity against bacteria commonly found in dogs.
(i)In vitro potentiated amoxicillin is active against a wide range of clinically important aerobic and anaerobic bacteria including:
Gram-positive:
Staphylococci (including β-lactamase producing strains)
Clostridia; Corynebacteria
Peptostreptococcus spp
Streptococci
Gram-negative:
Bacteroides spp (including β-lactamase producing strains)
Escherichia coli (including most β-lactamase producing strains)
Salmonellae (including β-lactamase producing strains)
Bordetella bronchiseptica
Campylobacter spp
Fusobacterium necrophorum
Klebsiellae; Pasteurellae
Proteus spp
Clinically Nisamox Tablets have been shown to be effective in (ii) treating a wide range of diseases of dogs including: Skin disease (including deep and superficial pyodermas); soft tissue infections (abscesses and anal sacculitis); dental infections (e.g. gingivitis); urinary tract infections; respiratory disease (involving upper and lower respiratory tract); enteritis.
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Dosage and administration
Administration: By the oral route. The tablets may be crushed and added to a little food.
Dosage rate: 12.5 mg/kg bodyweight. This is equivalent to one 50 mg tablet per 4 kg bodyweight or one 250 mg tablet per 20 kg bodyweight.
Dosage frequency: The following table is intended as a guide to dispensing Nisamox Tablets at the standard dose rate of 12.5 mg/kg twice daily.
For the majority of infections, including those of the skin, urinary tract and gastrointestinal tract, the above dosage regime is effective. Refractory cases however, particularly those of the respiratory tract, have shown improved cure rates by doubling the dose to 25 mg/kg bodyweight twice daily. (Note that the smallest animals of 1 kg bodyweight when dosed with ½ the 50 mg tablet will already be receiving the doubled (25 mg/kg) dose rate.
Duration of therapy: Routine cases involving all indications: The majority of cases respond to between 5 and 7 days therapy.
Chronic or refractory cases: In these cases where there is considerable tissue damage, a longer course of therapy may be required in that it allows sufficient time for damaged tissue to repair. Based on clinical trials, the following durations are suggested as guidelines.
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Contra-indications, warnings, etc
For animal treatment only. Nisamox Tablets should not be given to rabbits, guinea pigs, hamsters or gerbils. Caution is advised in their use in any other very small herbivores.
Operator Warnings
Penicillins and cephalosporins may cause hypersensitivity (allergy) following injection, inhalation, ingestion or skin contact. Hypersensitivity to penicillins may lead to cross-reactions to cephalosporins and vice versa. Allergic reactions to these substances may occasionally be serious.
Do not handle this product if you know you are sensitised, or if you have been advised not to work with such preparations. Handle this product with great care to avoid exposure, taking all recommended precautions.
If you develop symptoms following exposure such as a skin rash, you should seek medical advice and show the doctor this warning. Swelling of the face, lips or eyes or difficulty with breathing are more serious symptoms and require urgent medical attention.
Pharmaceutical precautions
Do not store above 25°C. Store in a dry place.
Keep out of the reach of children.
Dispose of used packaging in the household refuse. Unused product should be returned to the veterinary surgeon.
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Legal category
POM-V (previously POM.
Packaging Quantities
Nisamox Tablets 50 mg:
Packs of 10 and 50 blister strips containing 10 (50 mg) tablets per strip
Nisamox Tablets 250 mg:
Packs of 10 and 50 blister strips containing 5 (250 mg) tablets per strip
Further information
Resistance to many antibiotics is caused by beta-lactamase enzymes which destroy the antibiotic before it can act on the bacteria themselves. The clavulanate in Nisamox Tablets counteracts this defence mechanism by inactivating the beta-lactamases, thus rendering the organisms sensitive to amoxicillin’s rapid bactericidal effect, at concentrations readily attainable in the body.
Nisamox Tablets are effective against Klebsiella infections found in veterinary practice, but it is not indicated for cases involving Pseudomonas species.
Marketing authorisation number
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