Doxycycline Water Soluble Powder

Description

1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Doxycycline Hyclate Water Soluble Powder 50%
2. COMPOSITION
Each g contains
Active Substance: Doxycycline Hyclate…………………………………………………500 mg
Excipients:             Anhydrous glucose add to……………………………………………….1 g
3. PHARMACEUTICAL FORM
Oral Water Soluble Powder.

4. CLINICAL PARTICULARS
4.1 Target animals
Chickens (broilers), Pigs (Fattening pigs)
4.2 Indications
Tetracycline antibiotics. Used to treat Escherichia coli, Salmonella, Pasteurella, and respiratory
diseases caused by Gram positive and negative bacteria in pigs and chickens.

4.3 Dosage and administration
Mixed drink:
Pigs: 100g/1000L of water; Chicken: 100g/ 500-1000 L of water. Continuous use for 3-5 days.

4.4 Contraindications
(1) Prohibited during laying period for laying hens. (2) Avoid taking it at the same time as feed with high calcium content.

4.5 Special warnings and special precautions for use
Special precautions for use in animals. Due to variability (time, geographical) in susceptibility of bacteria for doxycycline, bacteriological sampling and susceptibility testing of micro-organisms from diseased animals on farm are highly
recommended.If this is not possible, therapy should be based on local (regional and farm level) epidemiological information about susceptibility of the target bacteria as well as by taking into account official national antimicrobial policies. As eradication of the target pathogens may not be achieved, medication should therefore be combined with good management practices, e.g. good hygiene, proper ventilation, no overstocking. Avoid administration in oxidised drinking equipment Inappropriate use of the product may increase the prevalence of bacteria resistant to doxycyclin and may decrease the effectiveness of treatment with other tetracyclines due to the potential for crossresistance. Do not use at concentrations lower than 0.23 g of powder /l in drinking water with pH higher or equal to 7.5 to avoid precipitation. Do not add acid to the medicated drinking water. Special precautions for the person administering the veterinary medicinal product to animals People with known hypersensitivity to tetracyclines should avoid contact with the veterinary medicinal product During preparation and administration of the medicated drinking water, skin contact with the product and inhalation of dust particles should be avoided. 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. In the event of eye or skin contact, rinse the affected area with large amounts of clean water and if irritation occurs, seek medical attention. Wash hands and contaminated skin immediately after handling the product. If you develop symptoms following exposure such as skin rash, you should seek medical advice and show this warning to the physician. Swelling of the face, lips or eyes, or difficulty with breathing are more serious symptoms and require urgent medical attention. Do not smoke, eat or drink while handling the product. Take measures to avoid producing dust when incorporating the product into water. Avoid direct
contact with skin and eyes when handling the product to prevent sensitisation and contact dermatitis.

4.6 Side Effects
Long term use can cause secondary infection and liver damage. Hypersensitivity reactions may occur.

4.7 Use during pregnancy, lactation or lay
The product should not be used during pregnancy or lactation. Do not use within 4 weeks of onset of the laying period.

4.8 Interaction with other medicinal products and other forms of interaction
Long term use can cause secondary infection and liver damage. Do not administer together with bactericidal antibiotics (penicillins, aminoglycosides, etc.). Absorption of doxycycline can be decreased in the presence of high quantities of calcium, iron, magnesium or aluminium in the diet. The solubility of the product is pH dependent and will precipitate if mixed in alkaline solution.

4.9 Overdose

The administration of 40 mg/kg BW in pigs and 80 mg/kg in chickens (in both species corresponding
to 4 times the recommended dose), for 5 days did not cause any adverse reaction. In case of overdose the treatment should be suspended and symptomatic treatment established. 4.10 Withdrawal times
28 days. Prohibited during laying period for laying hens.

 5.1 Shelf life
Shelf-life of veterinary medicinal product as packaged for sale: 36months. 6.4 Special precautions for storage. Store below 30℃, in a cool and dry place, and protect from light. For veterinary use only. Keep out of reach of children.

5.2 Nature and contents of container
The veterinary medicinal product Primary packaging: PE bag Outer packaging : Polyethylene barrel. 6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products, if appropriate
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with national requirements.

Notes: