Introduction

Company name: CEVA Animal Health Ltd

Address: 90 The Broadway

Chesham

Buckinghamshire

HP5 1EG

Telephone: 01494 781510

Fax: 01494 781519

Email: cevauk@ceva.com

Website: www.ceva.uk.com

Presentation

A water soluble powder for oral solution containing 500 mg/g of doxycycline hyclate.

Uses

For the treatment of the clinical signs associated with porcine respiratory disease caused by Actinobacillus pleuropneumoniae, Pasteurella multocida, and Mycoplasma hyopneumoniae susceptible to doxycycline.

Doxycycline is a broad-spectrum antimicrobial, active against a large number of Gram-positive and Gram-negative, aerobic and anaerobic micro-organisms, Mycoplasma, Chlamydiae and Rickettsia.

Dosage and administration

Administer orally via drinking water.

The recommended dosage for pigs is 12.5 mg doxycycline hyclate per kg bodyweight per day for 4 days.

If no improvement in clinical signs is seen within this time, the diagnosis should be reviewed and treatment changed. In case of severe infections the medication period may be prolonged for a maximum of 8 days as determined by the attending veterinary surgeon. Based on the dose to be used, and the number and weight of the animals to be treated, the exact daily amount of product can be calculated.

The use of suitably calibrated weighing equipment is recommended if part packs are used.

The daily amount is to be added to the drinking water such that all medication will be consumed in 24 hours.

It is recommended to prepare a concentrated pre-solution (approximately 100 grams product per litre drinking water) and to dilute this further to therapeutic concentrations as required.

Alternatively, the concentrated solution can be used in a proportional water medicator.

To ensure a correct dosage, bodyweight should be determined as accurately as possible to avoid underdosing.

The uptake of medicated drinking water depends on the clinical condition of the pigs. In order to obtain the correct dosage the concentration of doxycycline has to be adjusted accordingly.

Contra-indications, warnings, etc

The use of doxycycline in animals with an impaired liver function should be avoided.

Do not combine with bactericidal antimicrobials such as penicillins or cephalosporins.

Solubility of doxycycline is pH dependent. Precipitation will occur in an alkaline solution. This product should therefore not be mixed with other products.

Withdrawal periods

Meat: 10 days

Special precautions for use in animals

Due to likely variability (time, geographical) in susceptibility of bacteria for doxycycline, bacteriological sampling and susceptibility testing are recommended.

Special precautions to be taken by the person administering the veterinary medicinal product to animals

During preparation and administration of the medicated drinking water, skin contact with the drug and inhalation of dust particles should be avoided. Therefore, it is recommended to wear impermeable gloves e.g. rubber or latex and an appropriate dust mask e.g. disposable half-mask respirator conforming to European Standard EN149 when applying the product. If you know you are allergic to the tetracycline class of antimicrobials, special care should be taken when handling this product or the medicated solution.

In the event of eye contact, rinse the eye with copious amounts of clean water and if irritation occurs, seek medical attention.

In the event of accidental ingestion, seek medical advice.

Wash hands and contaminated skin immediately after handling the product.

Use during pregnancy or lactation

In the absence of specific studies the use of the product is not recommended during pregnancy or lactation.

For animal treatment only. Keep out of the reach and sight of children.

Pharmaceutical precautions

This veterinary medicinal product does not require any special storage conditions.

Legal category

POM-V

Packaging Quantities

Aluminium sachets of 100, 250, 500g and 1 kg.

Not all pack sizes may be marketed.

Further information

Refer to table "Recent MIC's of doxycycline for porcine respiratory pathogens"

Recent MIC's of doxycycline for porcine respiratory pathogens
Pathogen	Year of isolation	Country	MIC50 in µg/ml	MIC90 in µg/ml	% ≤ 1.0 µg/ml	Number of isolates
P. multocida	2001	Spain	0.1	0.5	>90%	21
	2003/2005	UK	0.25	0.25	100%	20
	2004/2005	Germany	0.5	2.0	88%	653
B. bronchiseptica	2001	Spain	0.04	0.05	>90%	15
A. pleuropneumoniae	2001	Spain	1.4	2.4	<50%	15
	2003/2005	UK	1.0	2.0	60%	20
	2004/2005	Germany	1.0	1.0	91%	124
M. hyopneumoniae	2001	Spain	0.1	0.2	>90%	19
	2003-2005	UK/Belgium	0.125	0.5	95%	20
	2000-2002	Belgium	0.5	1.0	90%	21

Marketing authorisation number

Vm16849/4003.

Significant Changes