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

Clear, dense, brownish-yellow oral solution for use in drinking water.

Contains 100mg doxycycline/ml (as doxycycline hyclate)

Uses

For chickens (broilers) and pigs

Broilers: prevention and treatment of chronic respiratory disease (CRD) and mycoplasmosis caused by microorganisms sensitive to doxycycline.

Pigs: prevention of clinical respiratory disease due to Pasteurella multocida and Mycoplasma hyopneumoniae sensitive to doxycycline.

Dosage and administration

Chickens (broilers): 10-20mg of doxycycline/kg BW/ day for 3-5 days (i.e. 0.5-1.0 ml of product/litre of drinking water/day)

Pigs: 10mg of doxycycline/kg BW/ day for 5 days (i.e. 1 ml of product/10kg BW/day)

Medicated water should be the only drinking source.

To ensure a correct dosage bodyweight should be determined as accurately as possible to avoid underdosing. The uptake of medicated water depends on the clinical condition of the animals. In order to obtain the correct dosage the concentration of doxycycline has to be adjusted accordingly.Use appropriate and properly calibrated dosing equipment. The medicated water is only usable for 24 hours and should be made freshly every day. The remaining medicated water should be disposed of in accordance with local requirements. If no improvement in clinical signs is seen within the treatment duration,the diagnosis should be reviewed and treatment changed.

Contra-indications, warnings, etc

Withdrawal times:

Meat & offal

Chickens (broilers): 7 days

Pigs: 7 days

Eggs: not permitted for use in laying birds producing eggs for human consumption.

Do not use in case of hypersensitivity to tetracyclines. Do not use in animals with hepatic dysfunction.

User warnings: Do not handle the product if you are hypersensitive to tetracyclines. Wear gloves, work overall and approved safety glasses. This product is acid and likely to be irritant. Avoid contact with skin and eyes. In case of contact with skin, rinse immediately with plenty of water. In case of contact with eyes, rinse immediately with copious amounts of water and seek medical advice. Do not smoke, eat or drink while handling this product. Administer the product with caution. The product can be harmful by skin contact and inhalation may cause eye irritation. In case of accidental ingestion, seel medical advise and show the label to the doctor. If any symptom should appear, such as cutaneous eruption, seek prompt medical advice. Swelling of the face, lips or eyes or respiratory difficulties are the most serious signs which require urgent medical attention.

Special warnings: do not administer to laying birds four weeks before the start of lay and during lay. The product should not be used during pregnancy or lactation. Avoid administration in oxidised drinking equipment. Resistance against doxycycline may vary: therefore use of the product should be based on culture and sensitivity of micro-organisms form diseased cases on the farm or from recent experience on the farm. Inappropriate use of the product may increase the prevalence of bacteria resistant to doxycycline and may decrease the effectiveness of treatment with tetracyclines, due to the potential for cross-resistance. Doxycycline absorption may be reduced by the presence of high quantities of calcium, iron, magnesium or aluminium in the diet. Do not administer together with antacids, kaolin and iron preparations. Do not administer together with bactericidal antibiotics. The solubility of the product is pH dependent and wil precipitate if mixed in alkaline solution. Do not administer with milk replacers.