Q1956_soludox_500_mg_g.1_9.tp

Dechra Veterinary Products
Limited
(A business unit of Dechra
Pharmaceuticals PLC)
Sansaw Business Park
Hadnall, Shrewsbury
Shropshire SY4 4AS
Tel: 01939 211200
SOLUDOX® 500 MG/G POWDER FOR USE IN
farm level) epidemiological information about sus- DRINKING WATER FOR PIGS AND CHICKENS
As eradication of the target pathogens may not be Qualitative and quantitative composition
achieved, medication should therefore be combined with good management practices, e.g. good hygiene, Doxycycline hyclate 500 mg, corresponding to 433 proper ventilation, no overstocking.
For a full list of excipients, see Excipients.
Special precautions to be taken by the person admin-istering the veterinary medicinal product to ani- Pharmaceutical form
If you know you are allergic to the tetracycline class of antibiotics, special care should be taken whenhandling this product or the medicated solution.
Clinical particulars
During preparation and administration of the medi- cated drinking water, skin contact with the product and inhalation of dust particles should be avoided.
Wear impermeable gloves (e.g. rubber or latex) and Pigs: For the treatment of the
an appropriate dust mask (e.g. disposable half-mask clinical signs associated with porcine respiratory respirator conforming to European Standard EN149) disease caused by Actinobacillus pleuropneumoniae, Pasteurella multocida, and Mycoplasma hyopneu- In the event of eye or skin contact, rinse the affected moniae susceptible to doxycycline.
area with large amounts of clean water and if irritation Chickens: Where clinical disease is present in the
occurs, seek medical attention. Wash hands and flock, to reduce mortality, morbidity, and clinical contaminated skin immediately after handling the signs and to reduce lesions due to Pasteurellosis product. If you develop symptoms following expo- caused by Pasteurella multocida or to reduce morbid- sure such as skin rash, you should seek medical ity and lesions in respiratory infections caused by advice and show this warning to the physician.
Ornithobacterium rhinotracheale (ORT).
Swelling of the face, lips or eyes, or difficulty withbreathing are more serious symptoms and require sitivity to the active substance or to any of the Do not smoke, eat or drink while handling the Do not use in animals with an impaired liver Take measures to avoid producing dust when incorporating the product into water.
Avoid direct contact with skin and eyes when Special precautions for use in animals: handling the product to prevent sensitisation and variability (time, geographical), susceptibility of bac- teria to doxycycline (especially susceptibility of A.
pleuropneumoniae and O. rhinotracheale) may differ from country to country and even farm to farm, cases, induce photosensitivity and allergic reactions.
bacteriological sampling and susceptibility testing If suspected adverse reactions occur, treatment are recommended. Use of the product should be should be discontinued. Inform your veterinary sur- based on culture and sensitivity of micro-organisms geon if adverse reactions occur that are not stated.
from diseased cases on the farm. If this is not Use during pregnancy and lactation: Doxycycline possible, therapy should be based on local (regional, has a low affinity for forming complexes with calcium and studies have demonstrated that doxycycline concentrations if required. Alternatively, the concen- scarcely affects skeleton formation. No negative ef- trated solution can be used in a proportional water fects were observed in poultry after the administra- medicator. Solubility of the product is pH dependent tion of therapeutic doses of doxycycline.
and it may precipitate if it is mixed in hard alkaline In the absence of specific studies the use of the drinking water. Use at minimum concentrations of product is not recommended during pregnancy or 200 mg powder per litre drinking water in areas with hard alkaline drinking water (hardness above 10.2˚dand pH more than 8.1). During the treatment period animals should not have access to other water are bacteriocidal, e.g. penicillins or cephalosporins.
Absorption of doxycycline can be decreased in the presence of high quantities of calcium, iron, magne- sium or aluminium in the diet. Do not administer recommended dose resulted in no clinical signs that together with antacids, kaolin or iron preparations.
could be attributed to treatment. Poultry tolerate It is advised that the interval between the adminis- double overdoses of doxycycline (40 mg/kg body tration of other products containing polyvalent cati- weight) without any clinical effect.
ons should be 1-2 hours because they limit theabsorption of tetracyclines.
Withdrawal periods: Pigs: Meat and offal - 4 days.
Doxycycline increases the action of anticoagulants.
Chickens: Meat and offal - 3 days, following a dose The solubility of the product is pH dependent and rate of 10 mg/kg body weight for 4 days.
will precipitate if mixed in alkaline solution.
Meat and offal - 12 days, following a dose rate of 20 Do not store the drinking water in metallic contain- Eggs: Not authorised for use in laying birds produc- Amounts to be administered and administration ing eggs for human consumption. Do not use within route: Administration orally with the drinking water.
The recommended dose in pigs is: 12.5 mg doxy-
cycline hyclate (25 mg product) per kg body weight Pharmacological
particulars
per day for 4 consecutive days. If no improvement in group: Antibacterial, Tetracycline.
clinical signs is seen within this time, the diagnosis should be reviewed and treatment changed. In caseof severe infections the medication period may be Pharmacodynamic properties: Doxycycline belongs prolonged for a maximum of 8 consecutive days as to the group of the tetracycline antibiotics. These determined by the attending veterinary surgeon.
antibiotics have a broad-spectrum of antimicrobial The recommended dose in chickens is: 10 mg
activity, sharing the same basic structure of polycyclic doxycycline hyclate (20 mg product) per kg body weight per day for 3-4 consecutive days in case of Doxycycline is primarily a bacteriostatic drug. It infections caused by P. multocida and 20 mg doxycy- exerts its action by inhibiting the protein synthesis of cline hyclate (40 mg product) per kg body weight per the bacterial cell. Inhibition of bacterial protein syn- day for 3-4 consecutive days in case of infections thesis results in disturbance of all functions necessary for the life of bacteria. Cell-division and the formation Based on the dose to be used, and the number and of the cell wall in particular, are impaired.
weight of the animals to be treated, the exact daily Doxycycline is a broad-spectrum antibiotic, active amount of product can be calculated. The following against a large number of gram-positive and gram- formula can be used to calculate the concentration of negative, aerobe and anaerobe micro-organisms, Mycoplasmata, Chlamydiae and Rickettsia.
For Ornithobacterium rhinotracheale results dem- onstrate a great variation from high to low suscepti- bility, depending on the geographical region where In pig pathogens resistance against doxycycline may also vary; susceptibility figures of A. pleuropneu- moniae in particular may differ from country to Four resistance mechanisms acquired by micro- organisms against tetracyclines in general have been To ensure a correct dosage body weight should be reported: decreased accumulation of tetracyclines determined as accurately as possible. The uptake of (decreased permeability of the bacterial cell wall and medicated drinking water depends on the clinical active efflux), protein protection of the bacterial condition of the pigs/chickens. In order to obtain the ribosome, enzymatic inactivation of the antibiotic and correct dosage the concentration of doxycycline has rRNA mutations (preventing the tetracycline binding to be adjusted accordingly. The use of suitably to ribosome). Tetracycline resistance is usually ac- calibrated weighing equipment is recommended if quired by means of plasmids or other mobile ele- part packs are used. The daily amount is to be added to the drinking water such that all medication will be Cross-resistance between tetracyclines has also been consumed in 24 hours. Medicated drinking water described. Due to the greater liposolubility and should be refreshed or replaced every 24 hours. It is greater facility to pass through cell membranes (in recommended to prepare a concentrated pre-solu- comparison to tetracycline), doxycycline retains a tion, approximately 100 grams product per litre certain degree of efficacy against microorganisms drinking water, and to dilute this further to therapeutic with acquired resistance to tetracyclines.
product remaining after 24 hours should be dis- sorbed in the stomach and the first part of the duodenum. Compared to the older tetracyclines the absorption of doxycycline is less affected by the dicinal product does not require any special storage presence of bivalent cations in food. Bioavailability in conditions. Keep the bag tightly closed after first non-fasted pigs is approximately 21%.
opening in order to protect from moisture. Keep out Following oral administration at a dose of 12.8 mg/ kg body weight, steady state concentrations duringmedication range between a C • Polyester / polyethylene / aluminium / polyethy- Following administration of doxycycline hyclate at lene and an inner layer of polyethylene.
an actual dose of 21 mg/kg body weight to chickens • Polyester / polyethylene / aluminium and an inner mean plasma concentrations above 1 μg/ml were reached within 6 hours and lasted for 6 hours after • Polyethylene terephtalic acid / aluminium / poly- cessation of medication. From 24 hours up to 96 amide and an inner layer of polyethylene.
hours after start of treatment the doxycycline plasma Pack sizes of 100g, 250g, 500g, 1 kg and 10x100g in Following administration of doxycycline hyclate at an actual dose of 10 mg/kg body weight steady-stateplasma concentrations ranged from 0.75 to 0.93 μg/g between 12 and 96 hours after start of medication.
or waste materials derived from such veterinary Because doxycycline is highly lipid soluble, it has a medicinal products should be disposed of in accor- good tissue penetration. Respiratory tract tissue: plasma ratios of 1.3 (healthy lungs), 1.9 (pneumonic Marketing authorisation holder (if different from
lungs) and 2.3 (nasal mucosa) have been reported for distributor)
doxycycline. Plasma protein binding is high (over 25, 5531 AE Bladel, The Netherlands.
90%). Doxycycline is scarcely metabolised. Doxycy-cline is primarily excreted with the faeces.
Marketing authorisation number Vm 16849/4015
Pharmaceutical particulars
authorisation
renewal 07.09.2011
Date of revision of the text October 2012
dependent. Precipitation will occur in an alkaline Any other information
solution. In the absence of compatibility studies, this To be supplied only on veterinary prescription.
product must not be mixed with other veterinary Manufacturing authorisation holder responsible for batch release: Eurovet Animal Health BV, Handelsweg 25, 5531 AE Bladel, The Netherlands.
product as packaged for sale: 3 years.
Legal category POM-V
Shelf life after first opening the immediate packag- GTIN (Global Trade Item No)
Shelf life after dilution or reconstitution according Soludox 500 mg/g Powder for Use in Drinking Water to directions: After reconstitution with water, any for Pigs and Chickens 1 kg: 08714225153589 Requested by: [email protected]
Approved datasheets found: 1
Creation date: 5/11/2012 14:7:40 (UK)
Approved for book but not on website: 0
Datasheets marked as draft (ignored): 0
Soludox 500 mg/g Powder for Use in Drinking Chicken meat: 3 days, following a dose rate of 10 mg/kg body weight for 4 days; 12 days, following adose rate of 20 mg/kg body weight for 4 days. Eggs:Not authorised for use in laying birds producingeggs for human consumption. Do not use within 4weeks of onset of the laying period.
Directory of participants
Dechra Veterinary Products
Limited
(A business unit of Dechra
Pharmaceuticals PLC)
Sansaw Business Park
Hadnall, Shrewsbury
Shropshire SY4 4AS
Tel: 01939 211200Fax: 01939 211201email: [email protected] LIST OF PRODUCTS BY THERAPEUTIC INDICATION List of Products by Therapeutic Indication
PHARMACEUTICALS
Antimicrobials
Oral preparations
List of Products by Species
Please note that a species in brackets after a product name may not necessarily be a part of that product namebut is intended to make the index easier to use.
Chickens
Soludox 500 mg/g Powder for Use in Drinking Water Soludox 500 mg/g Powder for Use in Drinking Water Pigs
Soludox 500 mg/g Powder for Use in Drinking Water
List of Products by Active Ingredients
This index of non-proprietary names (active ingredients) is provided to enable users of the Compendium toidentify the brand names of relevant products when only the non-proprietary names are known.
It should be noted that although different products may contain the same active ingredient this does not implythat they are equivalent in regard to bioavailability or therapeutic activity.
Some products contain a number of ingredients and it has not been possible in every instance to identify suchproducts by a reference in this index to each ingredient.
Non-proprietary name in bold type. Proprietary name in ordinary type.
Doxycycline Hyclate
Soludox 500 mg/g Powder for Use in Drinking GRED
IN
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IV
Alphabetical Index of Products
Use in Drinking Water for Pigsand Chickens

Source: http://dechra.eu/files/dechra/Downloads/Pharma/Datasheets/Soludox_500_mg_g_Powder-05-11-12.pdf