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Soludox

Main information

  • Trade name:
  • Soludox 500 mg/g Powder for Use in Drinking Water for Turkeys
  • Available from:
  • Eurovet Animal Health B.V.
  • Pharmaceutical form:
  • Powder for use in drinking water
  • Prescription type:
  • POM-V - Prescription Only Medicine – Veterinarian
  • 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 Turkeys
    United Kingdom
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • Turkeys
  • Therapeutic area:
  • Antimicrobial

Other information

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Status

  • Source:
  • VMD - Veterinary Medicines Directorate
  • Authorization status:
  • Authorized
  • Authorization number:
  • 16849/4046
  • Authorization date:
  • 28-08-2012
  • Last update:
  • 21-12-2016

Summary of Product characteristics

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Issued: August 2012

AN: 01495/2011

Summary of Product Characteristics

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Soludox 500 mg/g powder for use in drinking water for turkeys

FR: Soludox 433 mg/g powder for use in drinking water for turkeys

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

1 gram of powder contains:

Active substance:

Doxycycline hyclate 500 mg, corresponding to 433 mg doxycycline

FR: 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

Turkeys (broilers, breeders).

4.2 Indications for use, specifying the target species

Turkeys: treatment of clinical respiratory infections associated with Mycoplasma

gallisepticum susceptible to doxycycline

4.3 Contra-indications

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

excipients.

Do not use in animals with hepatic dysfunction.

4.4 Special warning for each target species.

The uptake of medication by animals can be altered as a consequence of illness. In

case of insufficient uptake of drinking water, turkeys should be treated parenterally.

4.5 Special precautions for use

Special precautions for use in animals

Inappropriate use of the product may increase the prevalence of bacteria resistant to

tetracycline due to the potential for cross resistance. Do not use when tetracycline

resistance has been detected in the herd/flock.

Page 1 of 6

Issued: August 2012

AN: 01495/2011

Use of the product should be based on susceptibility testing and take into account

official and local 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.

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)

As for all tetracyclines, on rare occasions allergic reactions and photosensitivity may

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

notice any serious effects or other effects not mentioned in this leaflet, please inform

your veterinary surgeon.

4.7 Use during pregnancy, lactation or lay

Laboratory studies in rats and rabbits have not produced any evidence of a

teratogenic, foetotoxic, maternotoxic effects.

4.8 Interaction with other medicinal products and other forms of interaction

Do not combine with antibiotics that are bactericidal 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.

Page 2 of 6

Issued: August 2012

AN: 01495/2011

Doxycycline increases the action of anticoagulants.

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

solution.

4.9 Amounts to be administered and administration route

Administration orally with the drinking water.

Dosage in turkeys: 25 mg doxycycline corresponding to 29 mg doxycycline hyclate

per kg of body weight daily (equivalent to 58 mg product per kg of body weight),

administered in the drinking water for 5 consecutive days.

The product should be administered continuously in the drinking water during the

whole period of treatment. Based on the dose to be used, and the number and

weight of the birds 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:

58 mg product / kg

body weight / day X Mean body weight (kg)

of birds to be treated = .... mg product per

l drinking water

Mean daily water consumption (l) per bird

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 birds. 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 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 birds should not

have access to other water sources than the medicated water.

4.10 Overdose (symptoms, emergency procedures, antidotes)

No adverse effects were observed after administration of doxycycline to turkeys at

the fivefold therapeutic dose for up to 10 days. If suspected toxic reactions do occur

due to extreme overdose, the medication should be discontinued and appropriate

symptomatic treatment should be initiated if necessary.

4.11 Withdrawal periods

Turkeys:

- Meat and offal: 12 days

- Eggs: Not to be used in birds producing eggs for human consumption

Page 3 of 6

Issued: August 2012

AN: 01495/2011

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, Mycoplasma

spp., Chlamydiae and Rickettsia.

The MIC90 of doxycycline against Mycoplasma gallisepticum strains isolated in

France, Germany and Hungary (2003-2009) was reported 0.5 µg/ml. The resistance

rate of M. gallisepticum isolates against doxycycline is low.

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

In general, doxycycline is quite rapidly and extensively absorbed from the

gastrointestinal tract, widely distributed in the organism, not metabolised to any

significant extent and excreted mostly via the faeces.

Pharmacokinetics of doxycycline after single oral administration to turkeys is

characterised by a quite rapid and substantial absorption from the gastrointestinal

tract providing peak plasma concentrations between 1.5 to 7.5 hours depending on

age and the presence of food. The drug is widely distributed in the organism with Vd

values close to or greater than 1, and exhibits an elimination half-life in turkeys of 7.9

to 10.8 hours. The protein binding ratio at therapeutic plasma concentrations is in the

range of 70-85%. The bioavailability in turkeys may vary between 25 and 64%, also

depending on the age and feeding. The presence of food in the gastrointestinal tract

determines a lower bioavailability compared to that obtained in the fasted state.

After continuous in-water administration of the product at dosages of 25 mg

doxycycline/kg in turkeys for 5 days the average plasma concentrations over the

whole treatment period were reported 2.24±1.02 µg/ml in turkeys. PK/PD analysis of

AUC/MIC90 data resulted in >24 h values that meet the requirements for

tetracyclines.

Page 4 of 6

Issued: August 2012

AN: 01495/2011

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

Shelf-life after first opening the immediate packaging: 6 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

Bags of 1 kg. Sachets of 100 grams packed per 10 in a carton box

1000 g bag: polyester, polyethylene, aluminium, polyethylene and an inner layer of

polyethylene

1000 g bag: polyethylene terephtalic acid, aluminium, polyamide and an inner layer of

polyethylene.

100 g sachet: polyester, polyethylene, aluminium and an inner layer of ionomer

(surlyn).

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.

Page 5 of 6

Issued: August 2012

AN: 01495/2011

7. MARKETING AUTHORISATION HOLDER

Eurovet Animal Health B.V.

Handelsweg 25

5531 AE Bladel

The Netherlands

8. MARKETING AUTHORISATION NUMBER

Vm 16849/4046

9. DATE OF FIRST AUTHORISATION

28 August 2012

10. DATE OF REVISION OF THE TEXT

August 2012

Page 6 of 6

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