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Doxx-Sol

Main information

  • Trade name:
  • Doxx-Sol 500 mg/g Powder for Use in Drinking Water/Milk Replacer for Pre-ruminant Calves, Pigs and Chickens
  • Available from:
  • Huvepharma N.V.
  • Pharmaceutical form:
  • Powder for oral solution
  • Prescription type:
  • POM-V - Prescription Only Medicine – Veterinarian
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug
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Documents

Localization

  • Available in:
  • Doxx-Sol 500 mg/g Powder for Use in Drinking Water/Milk Replacer for Pre-ruminant Calves, Pigs and Chickens
    United Kingdom
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • Cattle, Chickens, Pigs
  • Therapeutic area:
  • Antimicrobial

Other information

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Status

  • Source:
  • VMD - Veterinary Medicines Directorate
  • Authorization status:
  • Authorized
  • Authorization number:
  • 30282/4022
  • Authorization date:
  • 21-01-2015
  • Last update:
  • 21-12-2016

Summary of Product characteristics

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AN: 01208/2013

Issued: January 2015

SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Doxx-Sol 500 mg/g powder for use in drinking water/milk replacer for pre-ruminant

calves, pigs and chickens

Doxx-Sol 500 mg/g powder for use in drinking water/milk replacer for cattle, pigs and

chickens (Poland only)

Doxx-Sol 433 mg/g powder for use in drinking water/milk replacer for pre-ruminant

calves, pigs and chickens (France only)

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Per gram:

Active substance:

Doxycyclin hyclate 500 mg (equivalent to 433 mg doxycycline)

Excipients:

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Powder for use in drinking water/milk replacer. Yellowish powder. Clear solution when

dissolved in water.

4. CLINICAL PARTICULARS

4.1 Target species

Cattle (pre-ruminant calves), pigs, chickens, (broilers, breeders, replacement pullets)

4.2 Indications for use, specifying the target species

Treatment of the following specified infectious diseases of the respiratory tract and the

alimentary tract caused by micro-organisms susceptible to doxycycline

Cattle (Pre-ruminant calves):

- Bronchopneumonia and pleuropneumonia caused by Pasteurella spp., Streptococcus

spp., Trueperella pyogenes, Histophilus somni and Mycoplasma spp.

Pigs:

- Atrophic rhinitis caused by Pasteurella multocida and Bordetella bronchiseptica;

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AN: 01208/2013

Issued: January 2015

- Bronchopneumonia caused by Pasteurella multocida, Streptococcus suis and

Mycoplasma hyorhinis;

- Pleuropneumonia caused by Actinobacillus pleuropneumoniae.

Chickens (broilers, breeders, replacement pullets):

- Infections of the respiratory tract caused by Mycoplasma spp., Escherichia coli,

Haemophilus paragallinarum and Bordetella avium;

- Enteritis caused by Clostridium perfringens and Clostridium colinum.

4.3 Contraindications

Do not use in cases of known hypersensitivity to tetracyclines or to any of the

excipients.

Do not administer to animals with severe liver- or kidney insufficiency.

4.4 Special warnings for each target species

None.

4.5 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.

A high resistance rate of E. coli, isolated from chickens, against tetracyclines has been

documented. Therefore the product should be used for the treatment of infections

caused by E. coli only after susceptibility testing has been carried out. Resistance to

tetracyclines has also been reported in pig respiratory pathogens (A.

pleuropneumoniae, S. suis) and calf pathogens (Pasteurella spp) in some EU countries.

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.

Special precautions to be taken by the person administering the veterinary

medicinal product to animals

This product may cause contact dermatitis and/or hypersensitivity reactions if contact is

made with the skin or eyes (powder and solution), or if the powder is inhaled.

People with known hypersensitivity to tetracyclines should not handle the product. 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. Do not smoke, eat or drink while handling the product. In the event

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AN: 01208/2013

Issued: January 2015

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.

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

4.7 Use during pregnancy, lactation or lay

Due to depositing of doxycycline in young bone tissue, use of the product should be

limited during pregnancy and lactation.

Use only according to the benefit/risk assessment by the responsible veterinarian.

The safety of the product has not been shown in pregnant or lactating sows

4.8 Interaction with other medicinal products and other forms of interaction

Do not use in conjunction with bactericidal antibiotics, such as penicillins and

cephalosporins.

Tetracyclines can chelate cations (e.g. Mg, Mn, Fe and Al) and this may lead to

decreased bioavailability

4.9 Amounts to be administered and administration route

To be administered orally through the milk-replacer and/or the drinking water.

Cattle (Pre-ruminant calve)s: for use in milk replacer

10 mg doxycycline hyclate /kg body weight / day, corresponding to

20 mg of product per kg body weight, for 3-5 consecutive days,

divided over 2 administrations.

Pigs: for use in drinking water

10 mg doxycycline hyclate /kg body weight / day, corresponding to

20 mg of product per kg body weight, for 3-5 consecutive days.

Chickens (broilers, breeders, replacement pullets): for use in drinking water

25 mg doxycycline hyclate /kg body weight / day, corresponding to

50 mg of product per kg body weight, for 3-5 consecutive days.

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AN: 01208/2013

Issued: January 2015

For the administration through the drinking water, the exact daily amount of product

should be calculated, based on the recommended dose, and the number and weight of

the animals to be treated, according to the following formula:

mg product / kg

body weight / day x

Mean body weight (kg) of

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

litre drinking water

Mean daily water consumption (litre) per animal

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

possible.

The uptake of medicated water is dependent on the clinical conditions of the animals. In

order to obtain the correct dosage, the concentration in drinking water may have to be

adjusted.

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 freshly prepared every

24 hours. It is recommended to prepare a concentrated pre-solution - not exceeding 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. The water should be stirred until full dissolution of the

product is obtained.

Milk replacer: The veterinary medicinal product must first be dissolved in water before

adding the milk powder. The medicated milk replacer should be used immediately and

should be freshly prepared after 4hours at the latest.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

In calves acute, sometimes fatal myocardial degeneration can occur following single or

multiple dosages. Since mostly this is caused by overdosage, it is important to measure

the dosage accurately.

4.11 Withdrawal period

Meat and offal:

Calves: 7 days

Pigs: 8 days

Chickens: 5 days

Not authorised for use in laying birds producing eggs for human consumption.

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Antibacterial for systemic use, tetracyclines

ATCvet-code: QJ01AA02

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AN: 01208/2013

Issued: January 2015

5.1 Pharmacodynamic properties

Doxycycline is a broad spectrum antibiotic. It inhibits bacterial protein synthesis

intracellularly by binding on the 30-S ribosome subunits. This interferes with binding of

aminoacetyl-tRNA to the acceptor site on the mRNA ribosome complex and prevents

coupling of amino acids to the elongating peptide chains.

Doxycycline inhibits bacteria, Mycoplasma, Chlamydia, Rickettsia, and certain Protozoa.

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 quickly and almost completely absorbed from the intestine. The presence

of food in the intestine has no effect on the actual absorption of doxycycline. The

distribution of doxycycline and penetration of doxycycline throughout most body tissues

is good.

Following absorption, tetracyclines are hardly metabolized. In contrast to the other

tetracyclines, doxycycline is mainly excreted via the faeces.

Calves

After a dosage of 10 mg/kg body weight /day during 5 days, an elimination halftime

varying between 15 and 28 hours was found. The doxycycline plasma level reached an

average of 2.2 to 2.5 μg/ml.

Pigs

In pigs, no accumulation of doxycycline in plasma was found after treatment via the

drinking water. Mean plasma values of 0.44 ± 0.12 μg/ml after 3 days of medication with

an average dose of 10 mg/kg body weight were found.

Chickens

Steady state plasma concentrations of 2.05 ± 0.47 μg/ml were reached within 6 hours

after start of the medication and varied between 1.28 and 2.18 μg/ml with a dosage of

25 mg/kg body weight during 5 days.

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AN: 01208/2013

Issued: January 2015

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Citric acid, anhydrous

Lactose monohydrate

6.2 Incompatibilities

In the absence of compatibility studies, this product should not be mixed with other

veterinary medicinal products.

6.3 Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 30 months

Shelf life after first opening of the immediate packaging: 3 months.

Shelf life after reconstitution in drinking water: 24 hours.

Shelf life after reconstitution in milk replacer: 4 hours.

6.4 Special precautions for storage

This veterinary medicinal product does not require any special conditions.

6.5 Nature and composition of immediate packaging

Bags of 1 kg or 5 kg formed from polyethylene/aluminium/polyethylene terephtalate

laminate.

Not all pack sizes may be marketed.

6.6 Special precautions for the disposal of unused veterinary medicinal products

or waste materials derived from the use of such products

Any unused veterinary medicinal product or waste materials derived from such

veterinary medicinal product should be disposed of in accordance with local

requirements

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AN: 01208/2013

Issued: January 2015

7. MARKETING AUTHORISATION HOLDER

Huvepharma NV

Uitbreidingstraat 80

B-2600 Antwerp

Belgium

8. MARKETING AUTHORISATION NUMBER

Vm 30282/4022

9. DATE OF THE FIRST AUTHORISATION

21 January 2015

10. DATE OF REVISION OF THE TEXT

January 2015

Approved: 21/01/2015

Page 7 of 7

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