SUMMARYOF PRODUCT CHARACTERISTICS

SYNULOX PALATABLE DROPS, Powder for Oral Suspension

mg/ml when
Active ingredients: mg per bottle reconstituted

Amoxicillin 648.0 40.0
(as Amoxicillin Trihydrate) 743.9 45.92

Clavulanic acid 154.3 10.0
(as Potassium Clavulanate) 183.6 11.9

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

Powder for oral suspension. An off-white coloured powder for reconstitution.

Cats and dogs.

The product is indicated for the treatment of a wide range of diseases of cats and dogs including: skin diseases (including deep and superficial pyodermas); urinary tract infections; respiratory diseases (involving upper and lower respiratory tract); enteritis; soft tissue infections (abscesses and anal sacculitis); dental infections (e.g. gingivitis).

The product is effective against Klebsiella infections found in veterinary practice, but it is not indicated for cases involving Pseudomonasspecies.

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.

It is not advisable to use bacterial and bacteriostatic antibiotics in combination.

Reconstitution: Add 15 ml water. Shake the bottle before use.

Administration: by the oral route.

Dosage rate: 12.5 mg/kg bodyweight (i.e. 0.25 ml/kg). For the accurate dosing of particularly small patients it is valuable to note that one drop from the pipette provided contains 2.3 mg clavulanate-potentiated amoxicillin. Therefore 5-6 drops/kg twice daily are recommended as a guide.

Dosage frequency: Dogs and cats should be dosed at the rate of 0.25 ml of reconstituted product per kg bodyweight 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 (i.e. 0.5 ml of reconstituted product 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 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:

Chronic skin disease 10 - 20 days
Chronic cystitis 10 - 28 days
Respiratory disease 8 - 10 days

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 product has a notably broad spectrum of bactericidal activity against bacteria commonly found in cats and dogs.

In vitrothe product is active against a wide range of clinically important aerobic and anaerobic bacteria including:

Gram-positive

Staphylococci (including ß-lactamase producing strains)

Clostridia

Corynebacteria

Peptostreptococcusspp.

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.

Resistance to many antibiotics is caused by ß-lactamase enzymes which destroy the antibiotic before it can act on the bacteria themselves. The clavulanate in the product 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.

ATCvet Code:QJ01CR02

Xanthan Gum

Saccharin Sodium Anhydrous

Silica Colloidal Anhydrous

Succinic Acid

Silicon Dioxide (Silica Gel)

Strawberry Dry Flavour

Peach Dry Flavour

Lemon Dry Flavour

None known.

Shelf life of the veterinary medicinal product as packaged for sale: 18 months.

Shelf life after dilution or reconstitution according to directions: 7 days.

Do not store above 25^°C. The reconstituted product should be stored at 2-8^°C.

Any reconstituted product remaining 7 days after preparation should be discarded.

The product is supplied in glass bottles (containing 15ml of product following reconstitution). A dropper with graduations of 0.25 ml, up to 1 ml, is included in each pack to ensure accurate, convenient dosing.

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:42058/4144

Date:20 August 1990

Date:June 2014

26 June 2014