SUMMARY OF PRODUCT CHARACTERISTICS

SYNULOX PALATABLE TABLETS 250 mg

Active ingredients: mg per tablet

Amoxicillin 200.0
(as Amoxicillin Trihydrate) 229.5

Clavulanic acid 50.0
(as Potassium Clavulanate) 59.5

Erythrosine Lake (E127) 17.50

For the full list of all other excipients see section 6.1.

Tablet.

(Circular pink scored tablets).

Cats and dogs.

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.

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.

None.

None.

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.

None known.

The product can be safely used in pregnant and lactating animals.

None known.

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.

The product is of low order toxicity to the target species. No adverse side effects are to be expected from accidental overdose.

Not applicable.

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

Erythrosine Lake (E127)
Magnesium Stearate

Sodium Starch Glycollate, Type A

Silica Colloidal Anhydrous

Yeast Dried

Microcrystalline Cellulose

None known.

Shelf life of the veterinary medicinal product as packaged for sale: 2 years.

Do not store above 25^°C.

Store in a dry place.

Tablets are packed in laminated aluminium foil strips containing 5 x 2 tablets. 250 mg tablets are in packs of 100 and 250.

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

Zoetis UK Limited

5th Floor, 6 St. Andrew Street

London

EC4A 3AE

Vm:42058/4145

Date:20 August 1990

Date:June 2014

26 June 2014