Synulox Bolus 500 mg Film-Coated Tablets

Composition

Excipients:

Titanium Dioxide (E171) 26.58

Ponceau 4R Lake (E124) 0.546

Carmoisine Lake (E122) 0.399

Sunset Yellow Lake (E110) 0.357

Indigo Carmine Lake (E132) 0.119

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

6.1 List of excipients

Magnesium Stearate

Sodium Starch Glycollate Type A, dried

Silicon Dioxide

Microcrystalline Cellulose, dried

Film coating:

Ponceau 4R Lake (E124)

Carmoisine Lake (E122)

Sunset Yellow Lake (E110)

Indigo Carmine Lake (E132)

Titanium Dioxide E171

Hypromellose 5 mPa s

Hypromellose 15 mPa s

Polyethylene Glycol 4000

Polyethylene Glycol 6000

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Pharmaceutical form

Film-coated tablet.

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Pharmacological properties

In vitro, the combination is effective against a wide range of clinically important bacteria including:

Gram-positive

Staphylococci (including β-lactamase producing strains)

Streptococci

Corynebacteria

Clostridia

Actinomyces bovis

Gram-negative

Escherichia coli (including most β-lactamase producing strains)

Salmonellae (including β-lactamase producing strains)

Klebsiellae

Proteus spp.

Pasteurellae

Fusiformis spp.

Haemophilus spp.

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Target species

Calves.

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Indications

For the treatment of enteritis and navel ill in calves.

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Dosage

Orally. 6.25-12.5 mg/kg bodyweight twice daily. For example a 40 kg calf will require ½ bolus twice daily, but this may be doubled in cases of severe infection.

Treatment should be continued for up to 12 hours after the clinical signs have subsided, up to a maximum of 3 days of treatment.

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Contraindications

In common with other penicillins, the product should not be administered orally to rabbits, guinea pigs, hamsters or gerbils.

Do not use in animals with known sensitivity to the active ingredients.

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Adverse reactions

None known.

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Warnings

i) Special precautions for use in animals

None.

ii) 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 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.

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Use during pregnancy, lactation or lay

Not applicable.

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Interactions

None known.

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Overdose

The combination is of a low order of toxicity and is well tolerated by the oral route. Limited overdose normally produces no adverse effect.

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Special warnings

None.

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Withdrawal period

Meat: 9 Days.

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Incompatibilities

None known.

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Immediate packaging

Packs contain 20, 100 or 500 boli, which are pink biconvex film coated tablets packed in heat sealed aluminium foil.

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Storage

Do not store above 25°C.

Store in a dry place.

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Shelf life

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

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Disposal of unused product

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

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Additional information

Vm 42058/5177

9 DATE OF FIRST AUTHORISATION

01 November 1990

10 DATE OF REVISION OF THE TEXT

January 2025

Gavin Hall Approved: 14 January 2025

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Registration holder

Zoetis UK Limited

1st Floor, Birchwood Building

Springfield Drive

Leatherhead

Surrey

KT22 7LP

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