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Synulox Palatable Tablets 500mg (pack of 100) |
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Presentation
Synulox Palatable Tablets 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. The composition of the two tablet sizes is as follows:
50 mg
40 mg amoxicillin and 10 mg clavulanic acid.
250 mg
200 mg amoxicillin and 50 mg clavulanic acid.
Uses
Synulox Palatable Tablets have a notably broad spectrum of bactericidal activity against bacteria commonly found in cats and dogs.
In vitro Synulox is active against a wide range of clinically important aerobic and anaerobic bacteria including:
Gram-positive:
Staphylococci (including ß-lactamase producing strains); Clostridia; Corynebacteria; Peptostreptococcus spp; Streptococci.
Gram-negative:
Bacteroides spp (including ß-lactamase producing strains); Escherichia coli (including most ß-lactamase producing strains); Salmonellae (including ß-lactamase producing strains); Bordetella bronchiseptica; Campylobacter spp; Fusobacterium necrophorum; Klebsiellae; Pasteurellae; Proteus spp.
Clinically Synulox has been shown to be effective in treating a wide range of diseases of cats and dogs including: Skin disease (including deep and superficial pyodermas); soft tissue infections (abscesses and anal sacculitis); dental infections (eg gingivitis); urinary tract infections; respiratory disease (involving upper and lower respiratory tract); enteritis.
Contra-indications, warnings, etc
For animal treatment only. Synulox Palatable 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 warning
Penicillins and cephalosporins may cause hypersensitivity (allergy) following injection, inhalation, ingestion or skin contact. Hypersensitivity to penicillins may lead to cross reaction to cephalosporins and vice-versa. Allergic reaction 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. Wash hands after use.
Handle this product with great care to avoid exposure, taking all recommended precautions.
If you develop symptoms following exposure such as 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 may 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 any unused product and empty containers in accordance with guidance from your local waste regulation authority.
Legal category
POM-V (previously POM)
Packaging Quantities
Both size tablets are packed in foil strips containing 5×2 tablets. 50 mg tablets are supplied in packs of 100 and 500, 250 mg tablets are in packs of 100 and 250.
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 Synulox 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.
Synulox is effective against Klebsiella infections found in veterinary practice, but it is not indicated for cases involving Pseudomonas species.
Synulox Palatable Tablets are often accepted from the hand, even by sick dogs and cats. Alternatively, the tablets may be crumbled and added to a little food.
Synulox Palatable Tablets can safely be used during pregnancy and lactation.
Synulox Palatable Drops are available as an alternative presentation for treating small individuals.
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Presentation
Synulox Palatable Tablets are presented as circular, pink tablets with a break line on one face and `SYNULOX' engraved on the other. Each tablet contains 100 mg clavulanic acid as potassium clavulanate and 400 mg amoxicillin as Amoxicillin trihydrate Ph.Eur. in a palatable base.
Uses
Synulox Palatable Tablets have a broad spectrum of activity against bacteria commonly found in dogs.
In vitro Synulox is active against a wide range of clinically important aerobic and anaerobic bacteria, including:
Gram-positive Staphylococci (including beta-lactamase-producing strains), Clostridia Actinomyces, Peptostreptococcus spp., Streptococci Enterococci
Gram-negative Bacteroides spp. (including β-lactamase-producing strains), Escherichia coli (including beta-lactamase-producing strains), Salmonellae (including β-lactamase-producing strains), Bordetella bronchiseptica, Campylobacter spp., Fusobacterium necrophorum, Klebsiellae, Pasteurellae, Proteus spp.
Clinically, Synulox has been shown to be effective in treating a wide range of diseases of dogs including: Skin disease (including deep and superficial pyoderma); urinary tract infection; respiratory disease involving upper and lower respiratory tract, enteritis, dental infections (e.g. gingivitis), soft tissue infections (e.g. abscesses and anal sacculitis).
Note
Synulox is not indicated for cases involving Pseudomonas spp.
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Dosage and administration
Administration
By the oral route.
Dosage Guide
Recommended dose rate is 12.5 mg/kg, twice daily. The table below is intended as a guide only.
Bodyweight (kg) Number of Tablets per dose
Twice Daily
500 mg
20 kg ½
40 kg 1
60 kg 1½
80 kg 2
For oral administration only. Synulox Palatable Tablets are often accepted from the hand, even by sick dogs. Alternatively, the tablets may be crushed and added to a small quantity of food. The majority of routine cases will respond between 5 and 7 days therapy. Because of the low toxicity profile of Synulox, the dose can be doubled if desired at the discretion of the veterinary surgeon for severe infection. In certain indications, for example canine pyoderma and chronic cystitis, bacterial infection may be secondary to other pathology. For such cases longer courses of antibacterial therapy may be required, in addition to diagnosis and treatment of the underlying condition. In such circumstances overall treatment length must be at the clinician's discretion, but should be long enough to ensure complete resolution of the bacterial disease.
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Contra-indications, warnings, etc
In common with other penicillins, Synulox should not be administered orally to rabbits, guinea pigs hamsters or gerbils, and should be used with care in other small herbivores.
Synulox should not be administered concomitantly with bacteriostatic antibiotics, which are incompatible.
Operator warning
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 reaction 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 may require urgent medical attention.
In the event of accidential ingestion, seek medical advice.
Wash hands after handling the tablets.
For animal use only.
Keep out of the reach of children.
Pharmaceutical precautions
Do not store above 25°C. Store in a dry place.
Any unused product or waste material should be disposed of in accordance with national requirements.
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Legal category
POM-V (previously POM).
Packaging Quantities
Laminated aluminium foil packs with 2 tablets in each blister card. Packed in an outer carton box and marketed as a 100 tablet presentation.
Further information
Amoxicillin is a broad-spectrum antibiotic active against a wide range of Gram-positive and Gram-negative bacteria. However, many clinically important bacteria produce beta-lactamase enzymes which destroy this antibiotic. Clavulanic acid inactivates these enzymes, rendering the organisms susceptible to the amoxicillin.
Synulox Palatable Tablets can safely be used in pregnant and lactating animals
Marketing authorisation number
VM 00057/4102.
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