Introduction

Company name: Alpharma Belgium bvba

Address: Garden Square,

Laarstraat 16

2610 Antwerp - Belgium

Telephone: +44 1728621556 (Mobile: +44 7740 483818)

Fax: +44 1728621556

Email: patrick.garland@alpharma.com

Telephone: +44 140 025 0911 (Mobile: +44 771 734 5108)

Email: philip.keogh@alpharma.com

Website: www.alpharmaah.com

Presentation

Powder for oral solution, white to off-white flakes containing 1000mg/g Sodium salicylate

Uses

Target species: Calves and pigs

Pigs: Supportive treatment for relief of pain in musculoskeletal disorders in combination with appropriate (e.g. anti-infective) therapy if necessary.

Calves: Supportive treatment for reduction of pyrexia in acute respiratory disease, in combination with appropriate (e.g. anti-infective) therapy if necessary

Dosage and administration

Pigs: 35mg sodium salicylate/kg BW/day for 3 to 5 days. Orally in drinking water

Calves: 20mg sodium salicylate/kg BW/ day fro 1 to 3 days. Orally in drinking water or milk(replacer)

The following formula can be used to calculate the concentration of Solacyl® in drinking water or milk:

....mg Solacyl®/kg BW/d X mean body weight (kg) of animals to be treated /mean daily water or milk consumption (l) per animal = ....mg Solacyl® per l drinking water/milk

Alternatively Solacyl® can also be administered with the drinking water as pulse medication. Half of the calculated daily amount of powder is mixed with 5-10 litres of clean water and stirred until evenly dispersed. This solution is then added, whilst stirring, into an amount of drinking water that will be consumed within approximately 3-4 hours and administered twice daily.

Maximum solubility of Solacyl® in water is approximately 100g/litre.

The use of suitably calibrated weighing equipment for the administration of the calculated amount of sodium salicylate is recommended

Contra-indications, warnings, etc

Do not administer in case of severe liver and kidney disorder.

Do not administer in case of gastrointestinal ulcerations and chronic gastrointestinal disorders.

Do not administer in case of malfunction of the hematopoetic system, coagulopathy, haemorrhagic disease.

Use is not recommended during pregnancy and lactation because laboratory studies in rats have shown evidence of teratogenic and foetotoxic effects. Salicylic acid crosses the placenta and is excreted with the milk. Half-life in the new-born is longer and thus toxicity symptoms may occur much sooner. Furthermore platelet aggregation is inhibited and bleeding time increased, a situation which is not favourable during hard delivery/caesarean section. Finally some studies indicate that delivery is postponed.

Adverse reactions: Gastrointestinal irritation may occur especially in animals with pre-existing gastrointestinal disease. Such irritation may clinically be manifested by production of black manure due to blood loss in the gastrointestinal tract. Inhibition of normal blood clotting may occur incidentally. If this effect occurs it will be reversible and effects will diminish within approximately 7 days.

Interaction with other medicinal products and other forms of interaction: concurrent administration of potentially nephrotoxic drugs (e.g. aminoglycosides)) should be avoided. Salicylic acid is highly plasma bound and competes with a variety of compounds for plasma protein binding sites. Plasma clearance of SA had been reported to increase in combination with corticosteroids possible due to induction of metabolism of salicylic acid. Concurrent use with other NSAIDs is not recommended, because of increased risk of gastro-intestinal ulcers. Drugs which effect blood clotting should not be used in combination with sodium salicylate.

Special warning for each target species: non known.Special precautions for use: do not administer to neonates or to very young calves less than 2 weeks of age and piglets less than 4 weeks of age. Given that sodium salicylate may inhibit clotting of blood, it is recommended that elective surgery should not be performed on animals within 7 days after the end of treatment.Special precautions to be taken by the person administering the product to animals:People with known hypersensitivity to sodium salicylate or correlated pharmaceuticals should avoid contact with the veterinary medicinal product. Irritation of the skin, eye and respiratory tract might occur.During preparation and mixing of the product, direct contact with the skin and eyes, and direct inhalation of the powder should be avoided. It is recommended to wear gloves, safety glasses and a dust mask. Wash accidental exposure to skin immediately with water. During administration of the medicine ad reconstituted product in drinking water or milk (replacer) to the animals skin contact should be prevented by wearing gloves. Wash accidentally exposed skin immediately with water.

Withdrawal time:

Pigs: meat and offal: zero days

Calves: meat and offal: zero days

Do not use in cows producing milk for human consumption.

Pharmaceutical precautions

Shelf-life of the veterinary medicinal product as packaged for sale: 3 years

Shelf-life after first opening the immediate packaging: 6 months

Shelf-life after dilution or reconstitution according to directions: after reconstitution with

- water: any product remaining after 24hs should be discarded

- milk(replacer): any product remaining after 6 hours should be discarded.

Storage conditions: this veterinary medicinal product does not require any special storage conditions. Keep the bag tightly closed after first opening in order to protect from moisture.

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