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Soludox

Main information

  • Trade name:
  • Soludox 500 mg/g Powder for Use in Drinking Water for Pigs and Chickens
  • Available from:
  • Eurovet Animal Health BV
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug
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Documents

Localization

  • Available in:
  • Soludox 500 mg/g Powder for Use in Drinking Water for Pigs and Chickens
    United Kingdom
  • Language:
  • English

Other information

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Status

  • Source:
  • VMD - Veterinary Medicines Directorate
  • Authorization status:
  • Expired
  • Authorization number:
  • 16849/4014
  • Last update:
  • 21-12-2016

Summary of Product characteristics

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Revised: October 2012

AN: 00828/2012

SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Soludox 500 mg/g powder for use in drinking water for pigs and chickens

Soludox 433 mg/g powder for use in drinking water for pigs and chickens (France

only)

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

1 gram of powder contains:

Active substance:

Doxycycline hyclate 500 mg, corresponding to 433 mg doxycycline

France: Doxycycline 433 mg, corresponding to 500 mg doxycycline hyclate

Excipients:

For a full list of excipients, see section 6.1

3 PHARMACEUTICAL FORM

Powder for use in drinking water

Yellow crystalline powder

4 CLINICAL PARTICULARS

4.1 Target species

Pigs and chickens (broiler, pullet, breeder).

4.2 Indications for use, specifying the target species

Pigs: For the treatment of the clinical signs associated with porcine respiratory

disease caused by Actinobacillus pleuropneumoniae, Pasteurella multocida, and

Mycoplasma hyopneumoniae susceptible to doxycycline.

Chickens: Where clinical disease is present in the flock, to reduce mortality,

morbidity, and clinical signs and to reduce lesions due to Pasteurellosis caused by

Pasteurella multocida or to reduce morbidity and lesions in respiratory infections

caused by Ornithobacterium rhinotracheale (ORT).

4.3 Contra-indications

Do not use in case of hypersensitivity to the active substance or to any of excipients.

Do not use in animals with an impaired liver function.

4.4 Special warning for each target species.

None.

Page 1 of 6

Revised: October 2012

AN: 00828/2012

4.5 Special precautions for use

i. Special precautions for use in animals

Due to likely variability (time, geographical) in susceptibility of bacteria for

doxycycline, especially susceptibility of A. pleuropneumoniae and O.

rhinotracheale may differ from country to country and even farm to farm,

bacteriological sampling and susceptibility testing are recommended. Use of

the product should be based on culture and sensitivity of micro-organisms

from diseased cases on farm. If this is not possible, therapy should be based

on local (regional, farm level) epidemiological information about susceptibility

of the target bacteria.

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.

ii. Special precautions to be taken by the person administering the veterinary

medicinal product to animals

If you know you are allergic to the tetracycline class of antibiotics, special care

should be taken when handling this product or the medicated solution.

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 Adverse reactions (frequency and seriousness)

Tetracyclines may - in very rare cases - induce photosensitivity and allergic

reactions. If suspected adverse reactions occur, treatment should be discontinued.

Inform your veterinary surgeon if adverse reactions occur that are not stated.

4.7 Use during pregnancy, lactation or lay

Doxycycline has a low affinity for forming complexes with calcium and studies have

demonstrated that doxycycline scarcely affects skeleton formation. No negative

effects were observed in poultry after the administration of therapeutic doses of

doxycycline.

Page 2 of 6

Revised: October 2012

AN: 00828/2012

In the absence of specific studies the use of the product is not recommended during

pregnancy or lactation.

4.8 Interaction with other medicinal products and other forms of interaction

Do not combine with antibiotics that are bacteriocidal e.g. penicillins or

cephalosporins.

Absorption of doxycycline can be decreased in the presence of high quantities of

calcium, iron, magnesium or aluminium in the diet. Do not administered together with

antacids, kaolin and iron preparations.

It is advised that the interval between the administration of other products containing

polyvalent cations should be 1-2 hours because they limit the absorption of

tetracyclines.

Doxycycline increases the action of anticoagulants.

The solubility of the product is pH dependent and will precipitate if mixed in alkaline

solution.

Do not store the drinking water in metallic containers.

4.9 Amounts to be administered and administration route

Administration orally with the drinking water.

The recommended dose in pigs is:

12.5 mg doxycycline hyclate (25 mg product) per kg body weight per day for 4

consecutive 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 consecutive days as

determined by the attending veterinary surgeon.

The recommended dose in chickens is:

10 mg doxycycline hyclate (20 mg product) per kg body weight per day for 3-4

consecutive days in case of infections caused by P. multocida and

20 mg doxycycline hyclate (40 mg product) per kg body weight per day for 3-4

consecutive days in case of infections caused by O. rhinotracheale.

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 following formula

can be used to calculate the concentration of the product in drinking water:

mg product / kg body

weight / day x Mean body weight (kg) of

animals to be treated = .... mg product per l

drinking water

Mean daily water consumption (l) per animal

To ensure a correct dosage body weight should be determined as accurately as

possible. The uptake of medicated drinking water depends on the clinical condition of

the pigs/chickens. In order to obtain the correct dosage the concentration of

doxycycline has to be adjusted accordingly. 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.

Medicated drinking water should be refreshed or replaced every 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

Page 3 of 6

Revised: October 2012

AN: 00828/2012

concentrations if required. Alternatively, the concentrated solution can be used in a

proportional water medicator. Solubility of the product is pH dependent and it may

precipitate if it is mixed in hard alkaline drinking water. Use at minimum

concentrations of 200 mg powder per litre drinking water in areas with hard alkaline

drinking water (hardness above 10.2 °d and pH more than 8.1). During the treatment

period animals should not have access to other water sources than the medicated

water.

4.10 Overdose (symptoms, emergency procedures, antidotes)

Overdoses up to 1.6 times the label recommended dose resulted in no clinical signs

that could be attributed to treatment. Poultry tolerate double overdoses of

doxycycline (40 mg/kg body weight) without any clinical effect.

4.11 Withdrawal periods

Pigs:

- Meat and offal: 4 days

Chickens:

- Meat and offal: 3 days, following a dose rate of 10 mg/kg body weight for 4 days.

- Meat and offal: 12 days, following a dose rate of 20 mg/kg body weight for 4 days.

- Eggs: Not authorised for use in laying birds producing eggs for human

consumption.

Do not use within 4 weeks of onset of the laying period

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Antibacterial - Tetracycline.

ATC vet code: QJ 01 AA 02

5.1 Pharmacodynamic properties

Doxycycline belongs to the group of the tetracycline antibiotics. These antibiotics

have a broad spectrum of antimicrobial activity, sharing the same basic structure of

polycyclic naphthacenecarboxamide.

Doxycycline is primarily a bacteriostatic drug. It exerts its action by inhibiting the

protein synthesis of the bacterial cell. Inhibition of bacterial protein synthesis results

in disturbance of all functions necessary for the life of bacteria. Especially cell-

division and the formation of the cell wall are impaired.

Doxycycline is a broad-spectrum antibiotic, active against a large number of Gram-

positive and Gram-negative, aerobe and anaerobe micro-organisms, Mycoplasmata,

Chlamydiae and Rickettsia.

For Ornithobacterium rhinotracheale results demonstrate a great variation from high

to low susceptibility, depending on the geographical region where isolates came

from.

In pig pathogens resistance against doxycycline may also vary; especially

susceptibility figures of A. pleuropneumoniae may differ from country to country and

even farm to farm.

Page 4 of 6

Revised: October 2012

AN: 00828/2012

Four resistance mechanisms acquired by microorganisms against tetracyclines in

general have been reported: Decreased accumulation of tetracyclines (decreased

permeability of the bacterial cell wall and active efflux), protein protection of the

bacterial ribosome, enzymatic inactivation of the antibiotic and rRNA mutations

(preventing the tetracycline binding to ribosome). Tetracycline resistance is usually

acquired by means of plasmids or other mobile elements (e.g. conjugative

transposones). Cross resistance between tetracyclines has also been described.

Due to the greater liposolubility and greater facility to pass through cell membranes

(in comparison to tetracycline), doxycycline retains a certain degree of efficacy

against microorganisms with acquired resistance to tetracyclines.

5.2 Pharmacokinetic properties

Doxycycline is absorbed in the stomach and the first part of the duodenum.

Compared to the older tetracyclines the absorption of doxycycline is less affected by

the presence of bivalent cations in food. Bioavailability in non-fasted pigs is

approximately 21%.

Following oral administration at a dose of 12.8 mg/kg body weight, steady state

concentrations during medication range between a C

min of 0.40 µg/ml in the early

morning to a C

max of 0.87 µg/ml in the late afternoon in pigs.

Following administration of doxycycline hyclate at an actual dose of 21 mg/kg body

weight to chickens mean plasma concentrations above 1 µg/ml were reached within

6 hours and lasted for 6 hours after cessation of medication. From 24 h up to 96 h

after start of treatment the doxycycline plasma concentrations exceeded 2 µg/ml.

Following administration of doxycycline hyclate at an actual dose of 10 mg/kg body

weight steady state plasma concentrations ranged from 0.75 to 0.93 µg/g between

12 and 96 hours after start of medication.

Because doxycycline is highly lipid soluble, it has a good tissue penetration.

Respiratory tract tissue: plasma ratios of 1.3 (healthy lungs), 1.9 (pneumonic lungs)

and 2.3 (nasal mucosa) have been reported for doxycycline. Plasma protein binding

is high (over 90%).

Doxycycline is scarcely metabolised. Doxycycline is primarily excreted with the

faeces.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Tartaric acid

6.2 Incompatibilities

Solubility of doxycycline is pH dependent. Precipitation will occur in an alkaline

solution. In the absence of compatibility studies, this product must not be mixed with

other veterinary medicinal products.

6.3 Shelf life

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

Page 5 of 6

Revised: October 2012

AN: 00828/2012

Shelf-life after first opening the immediate packaging: 9 months

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

with water, any product remaining after 24 hours should be discarded.

6.4 Storage precautions

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.

6.5 Nature and composition of immediate packaging

The packs consists of one of the following laminates:

Polyester / polyethylene / aluminium / polyethylene and an inner layer

of polyethylene

Polyester / polyethylene / aluminium and an inner layer of ionomer

(surlyn).

Polyethylene terephtalic acid / aluminium / polyamide and an inner

layer of polyethylene.

Pack sizes of 100g, 250g, 500g, 1 kg and 10x 100g in a carton box

Not all pack sizes may be marketed.

6.6 Special precautions for the disposal of unused veterinary medicinal product or

waste materials derived from the use of such products

Any unused veterinary medicinal product or waste materials derived from such

veterinary medicinal products should be disposed of in accordance with local

requirements.

7. MARKETING AUTHORISATION HOLDER

Eurovet Animal Health B.V.

Handelsweg 25

5531 AE Bladel

The Netherlands

8. MARKETING AUTHORISATION NUMBER

Vm

16849/4014

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date: 8 September 2011

10. DATE OF REVISION OF THE TEXT

Date: October 2012

Approved by: 21/11/2012

Page 6 of 6

Document Outline

There are no safety alerts related to this product.

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