Synulox Palatable Tablets 50 Mg
Revised: November 2015
SUMMARY OF PRODUCT CHARACTERISTICS
NAME OF THE VETERINARY MEDICINAL PRODUCT
SYNULOX PALATABLE TABLETS 50 mg
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredients: mg per tablet
Amoxicillin 40.0
(as Amoxicillin Trihydrate) 45.9
Clavulanic acid 10.0
(as Potassium Clavulanate) 11.9
For the full list of all other excipients see section 6.1.
PHARMACEUTICAL FORM
Tablet.
(Circular pink scored tablets).
CLINICAL PARTICULARS
Target species
Cats and dogs.
Indications for use, specifying the target species
The producthas 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 (e.g. gingivitis); urinary tract infections; respiratory disease (involving upper and lower respiratory tract); enteritis.
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.
Special warnings for each target species
None.
Special precautions for use
Special precautions for use in animals
None.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
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.
Wash hands after use.
Adverse reactions (frequency and seriousness)
None known.
Use during pregnancy, lactation or lay
The product can be safely used in pregnant and lactating animals.
Interaction with other medicinal products and other forms of interaction
None known.
Amounts to be administered and administration route
Administration: by the oral
route.
Dosage rate: 12.5 mg/kg bodyweight.
Dosage
frequency: The following table is intended
as a guide to dispensing at the standard dose rate of 12.5 mg/kg,
twice daily.
|
Bodyweight (kg) |
Number of tablets per dose, twice daily |
|
|
|
50 mg |
250 mg |
|
1 - 2 |
½ |
- |
|
3 - 5 |
1 |
- |
|
6 - 9 |
2 |
- |
|
10 - 13 |
3 |
- |
|
14 - 18 |
4 |
- |
|
19 - 25 |
- |
1 |
|
26 - 35 |
- |
1 ½ |
|
36 - 49 |
- |
2 |
|
50 |
- |
3 |
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 of the respiratory tract, have shown improved cure rates by doubling the dose to 25mg/kg bodyweight twice daily.
Duration of therapy:
Routine cases involving all indications:
The majority of these 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 maybe required in that it allows sufficient time for damaged tissue to repair. Based on clinical trials, the following durations are suggested as guidelines:
Chronic skin disease 10 – 12 days
Chronic cystitis 10 – 28 days
Respiratory disease 8 – 10 days
The product is effective
against Klebsiellainfections found in veterinary practice, but it is not
indicated for cases involving Pseudomonasspecies.
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.
Overdose (symptoms, emergency procedures, antidotes), if necessary
The product is of low order toxicity to the target species. No adverse side effects are to be expected from accidental overdose.
Withdrawal period
Not applicable.
PHARMACOLOGICAL PROPERTIES
The ingredients have a notably broad spectrum of bactericidal activity against bacteria commonly found in cats and dogs.
Resistance to many antibiotics is caused by ß-lactamase enzymes which destroy the antibiotic before it can act on the bacteria themselves. The clavulanate counteracts this defence mechanism by inactivating the ß-lactamases, thus rendering the organisms sensitive to amoxicillin’s rapid bactericidal effect, at concentrations readily attainable in the body.
In vitroSynulox is active against a wide range of clinically important aerobic and anaerobic bacteria including:
Gram-positive: Staphylococci (including ß-lactamase producing strains); Clostridia; Arcanobacteria (Corynebacteria); Peptostreptococcus spp; Streptococci.
Gram-negative: Bacteroidesspp (including ß-lactamase producing strains); Escherichia coli(including most ß-lactamase producing strains); Salmonellae (including ß-lactamase producing strains);Bordetella bronchiseptica; Campylobacterspp; Fusobacterium necrophorum; Klebsiellae; Pasteurellae; Proteusspp.
ATCvet Code:QJ01CR02
PHARMACEUTICAL PARTICULARS
List of excipients
Erythrosine Lake
(E127)
Magnesium Stearate
Sodium Starch Glycollate, Type A
Silica Colloidal Anhydrous
Yeast Dried
Microcrystalline Cellulose
Incompatibilities
None known.
Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 2 years.
Special precautions for storage
Do not store above
25°C.
Store in a dry place.
Nature and composition of immediate packaging
Tablets are packed in laminated aluminium foil strips containing 5 x 2 tablets. 50 mg tablets are in packs of 100 and 500.
Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products, if appropriate
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
MARKETING AUTHORISATION HOLDER
Zoetis UK Limited
5th Floor, 6 St. Andrew Street
London
EC4A 3AE
MARKETING AUTHORISATION NUMBER
Vm:42058/4147
DATE OF FIRST AUTHORISATION
Date:20 August 1990
DATE OF REVISION OF THE TEXT
Date:June 2014
19 November 2015
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