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DFV Doxivet

Main information

  • Trade name:
  • DFV Doxivet 200 mg/ml, Solution for Use in Drinking Water for Pigs and Chickens
  • Available from:
  • Divasa - Farmavic S.A
  • Pharmaceutical form:
  • Solution 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:
  • DFV Doxivet 200 mg/ml, Solution for Use in Drinking Water for Pigs and Chickens
    United Kingdom
  • Language:
  • English

Therapeutic information

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

Other information

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Status

  • Source:
  • VMD - Veterinary Medicines Directorate
  • Authorization status:
  • Authorized
  • Authorization number:
  • 33229/4001
  • Authorization date:
  • 12-07-2011
  • Last update:
  • 21-12-2016

Summary of Product characteristics

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Revised: May 2016

AN: 01226/2015

SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

DFV DOXIVET 200 mg/ml, solution for use in drinking water for pigs and chickens.

ES: DFV DOXYCYCLINE 200 mg/ml, solution for use in drinking water for pigs and

chickens

IT: Doxycycline DFV 200 mg/ml, solution for use in drinking water for pigs and chickens

SE: Doxycycline Divasa-Farmavic 200 mg/ml lösning för användning I dricksvatten

DK: Doxycycline Divasa-Farmavic Vet.

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Composition for 1 ml:

Active substance:

Doxycycline hyclate 230 mg

Equivalent to 200 mg doxycycline base

Excipients:

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Solution for use in drinking water

Clear yellow-brown solution.

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 Contraindications

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

Do not use in animals with an impaired liver function.

Page 1 of 6

Revised: May 2016

AN: 01226/2015

4.4 Special warnings for each target species

None.

4.5 Special precautions for use

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.

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 should be avoided. Wear impermeable gloves (e.g. rubber or latex) 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.

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 (less than 1 animal in 10,000, including isolated

reports) - 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.

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.

Page 2 of 6

Revised: May 2016

AN: 01226/2015

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

iron, magnesium or aluminium in the diet. Do not administer 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 (0.054 ml 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 (0.043 ml 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 (0.087 ml 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:

..... ml product/ kg body

weight / day x mean body weight (kg) of

animals to be treated

= .... ml product per l

drinking water mean daily water consumption (l) per animal

at the previous day

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 animals. In

order to obtain the correct dosage the concentration of doxycycline has to be adjusted

accordingly. The use of suitably calibrated equipment is recommended if part containers

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. Solubility of the product is pH dependent and it may precipitate if it is

mixed in hard alkaline drinking water. During the treatment period animals should not have

access to other water sources than the medicated water.

Weight can also be used to measure the product quantity to be added in drinking water. In

this case the density correction should be used, according to the following formula:

Amount to be added in

drinking water (g/L) = amount to be added in drinking water (ml/L) x

1.075 (g/ml)

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

Page 3 of 6

Revised: May 2016

AN: 01226/2015

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 period(s)

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: Antiinfectives for systemic use, antibacterials for systemic

use, tetracycline, doxycycline

ATCvet code: QJ01AA02

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, MycoplasmataFor

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.

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 particulars

Page 4 of 6

Revised: May 2016

AN: 01226/2015

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

Ethanol anhydrous

Propylene glycol

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: 24 hours after dilution in

drinking water.

6.4. Special precautions for storage

This veterinary medicinal product does not require any special storage conditions.

6.5 Nature and composition of immediate packaging

Nature of container:

HDPE container with tamper-evident aluminium seal and HDPE screw cap.

Package sizes:

1 litre and 5 litres.

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

Page 5 of 6

Revised: May 2016

AN: 01226/2015

Any unused veterinary medicinal product or waste materials derived from such veterinary

medicinal product should be disposed of in accordance with local requirements.

7. MARKETING AUTHORISATION HOLDER

DIVASA-FARMAVIC S.A.

Ctra. Sant Hipòlit, km 71

08503 Gurb-Vic

Barcelona (Spain)

8. MARKETING AUTHORISATION NUMBER

Vm 33229/4001

9. DATE OF FIRST AUTHORISATION

12 July 2011

10. DATE OF REVISION OF THE TEXT

May 2016

PROHIBITION OF SALE, SUPPLY AND/OR USE

Not applicable.

26 May 2016

Page 6 of 6

There are no safety alerts related to this product.

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