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Altidox

Main information

  • Trade name:
  • Altidox 500 mg/g Powder for Use in Drinking Water for Pigs, Chickens and 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:
  • Altidox 500 mg/g Powder for Use in Drinking Water for Pigs, Chickens and Turkeys
    United Kingdom
  • Language:
  • English

Therapeutic information

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

Other information

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Status

  • Source:
  • VMD - Veterinary Medicines Directorate
  • Authorization status:
  • Authorized
  • Authorization number:
  • 16849/4056
  • Authorization date:
  • 21-10-2016
  • Last update:
  • 21-12-2016

Summary of Product characteristics

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Issued October 2016

AN: 00940/2015

SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Altidox 500 mg/g powder for use in drinking water for pigs, chickens and turkeys

Altidox 433 mg/g powder for use in drinking water for pigs, chickens and turkeys (FR)

Citridox 500 mg/g powder for use in drinking water for pigs, chickens and turkeys (PT)

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

1 g powder contains:

Active substance:

Doxycycline hyclate 500 mg, corresponding to 433 mg doxycycline

For the 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 (post-weaning), chickens (broilers, pullets, breeders) and turkeys (broilers, pullets,

breeders).

4.2 Indications for use, specifying the target species

Pigs: treatment of clinical respiratory infections caused by Mycoplasma hyopneumoniae

and Pasteurella multocida susceptible to doxycycline.

Chickens and turkeys: treatment of clinical respiratory infections associated with

Mycoplasma gallisepticum susceptible to doxycycline.

4.3 Contraindications

Do not use in case of known hypersensitivity to tetracyclines or to the excipient.

Do not use when tetracycline resistance has been detected in the herd/flock due to the

potential for cross-resistance.

Do not use in animals with impaired liver or kidney function.

4.4 Special warnings 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, animals should be treated parenterally.

Page 1 of 6

Issued October 2016

AN: 00940/2015

4.5 Special precautions for use

Special precautions for use in animals

The safety of the product has not been established in piglets before weaning.

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

tetracyclines due to the potential for cross-resistance.

Due to variability (time, geographical) in susceptibility of bacteria to doxycycline, 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.

Special precautions to be taken by the person administering the veterinary medicinal

product to animals

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.

People with known hypersensitivity to tetracyclines should avoid contact with the

veterinary medicinal product. 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 or a non-

disposable respirator to European Standard EN140 with a filter to EN143) 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.

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

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

foetotoxic or maternotoxic effects.

The safety of the product has not been established in pregnant or lactating sows. Use is

not recommended during pregnancy or lactation.

Do not use in birds in lay or within 4 weeks before the onset of the laying period.

Page 2 of 6

Issued October 2016

AN: 00940/2015

4.8 Interaction with other medicinal products and other forms of interaction

Do not administer concurrently with feed overloaded with polyvalent cations such as

Ca 2+ , Mg 2+ , Zn 2+ and Fe 3+ because the formation of doxycycline complexes with these

cations is possible. It is advised that the interval between administration of other

products containing polyvalent cations should be 1-2 hours because they limit the

absorption of tetracycline.

Do not administer together with antacids, kaolin or iron preparations.

Do not administer in conjunction with bactericidal antibiotics such as beta-lactames as

tetracyclines are bacteriostatic antimicrobials.

Doxycycline increases the action of anticoagulants.

4.9 Amounts to be administered and administration route

To be administered orally in the drinking water.

Dosage:

In pigs and chickens

20 mg doxycycline per kg body weight daily (equivalent to 46 mg product per kg body

weight), administered in the drinking water for 5 consecutive days.

In turkeys

25 mg doxycycline per kg body weight daily (equivalent to 58 mg product per kg body

weight), administered in the drinking water for 5 consecutive days.

Administration:

Based on the recommended dosage, and the number and weight of the animals to be

treated, the exact daily amount of the product to be administered should be calculated

according to the following formula:

.... mg product per kg body weight

per day x mean body

weight (kg) of

animals to be

treated = .... mg product per litre

of 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 condition 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 in such a way that

all medication will be consumed within 24 hours. Medicated drinking water should be

freshly prepared every 24 hours. It is recommended to prepare a concentrated pre-

solution and to dilute this further to therapeutic concentrations, if required. Alternatively;

the concentrated solution can be used in a proportional water medicator. The maximum

solubility of the product in water is at least 100 g/L.

It should be ensured that all animals intended to be treated should have free access to

the drinking facilities. At the end of treatment, the watering equipment should be cleaned

adequately to avoid the uptake of remaining quantities in sub-therapeutic doses. The

medicated water should be the only source of drinking water throughout the treatment

period. The medicated water must not be made or stored in a metal container or used in

Page 3 of 6

Issued October 2016

AN: 00940/2015

oxidised drinking equipment. Solubility of the product is pH-dependent and it may

precipitate if it is mixed in hard alkaline drinking water.

4.10 Overdose (symptoms, emergency procedures, antidotes)

During the target animal tolerance study, no adverse effects were observed in any of the

target animal species, even at the fivefold therapeutic dose administered for two times

the recommended duration.

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

Meat and offal:

Pigs: 4 days.

Chickens: 5 days.

Turkeys: 12 days.

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

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Antibacterial for systemic use, tetracyclines.

ATCvet code: QJ01AA 02

5.1 Pharmacodynamic properties

Doxycycline is a semisynthetic tetracycline derivative. It acts by inhibiting protein

synthesis at the ribosomal level, predominantly by binding to the 30S ribosomal subunits

of bacteria. Doxycycline is a broad-spectrum antibiotic. It exhibits a wide range of activity

against Gram-positive and Gram-negative, aerobic and anaerobic pathogens, especially

against Pasteurella multocida and Mycoplasma hyopneumoniae isolated from pig

respiratory infections and Mycoplasma gallisepticum associated with clinical respiratory

infections in chickens and turkeys. The MIC

90 values of doxycycline against Mycoplasma

hyopneumoniae strains isolated in Spain (2001) and in Belgium (2000-2002) were

determined as 0.2 and 0.5 µg/ml, respectively. The MIC

90 values for Pasteurella

multocida isolated in France and the United Kingdom (2002-2004), and Germany (2004-

2006) were found to be 2.0 µg/mL. The MIC

90 of doxycycline against M. gallisepticum

strains isolated in France, Germany and Hungary (2003-2009) was reported as 0.5

µg/ml.

The resistance rate of M. hyopneumoniae, P. multocida and M. gallisepticum isolates

against doxycycline is low (0-6%).

Four resistance mechanisms acquired by micro-organisms 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 transposons). 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 micro-organisms with acquired

resistance to tetracyclines.

Page 4 of 6

Issued October 2016

AN: 00940/2015

According to the CLSI regulation, organisms other than streptococci with MIC values ≤ 4

µg/ml are considered sensitive, at 8 µg/ml intermediate and with MIC values ≥ 16 µg/m

resistant to doxycycline.

5.2 Pharmacokinetic particulars

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 primarily in faeces, mostly in a microbiologically inactive

form.

After oral administration to pigs, doxycycline is substantially absorbed from the

gastrointestinal tract. The binding rate to plasma proteins is 93%. It is widely distributed

in the organisms; at the steady state, the volume of distribution (V

SS ) is 1.2 L/kg. The

elimination half-life was reported to be 4-4.2 hours in pigs. The steady-state plasma

concentrations of doxycycline after repeated oral administrations of the veterinary

medicinal product at a dose of 20 mg/kg body weight for 5 days ranged from 1.0 and 1.5

µg/ml. Both the lung and nasal mucosa concentrations at steady-state were higher than

the plasma level. The ratio between tissue- and plasma concentration was found to be

1.3 for lung and 3.4 for nasal mucosa. The doxycycline concentrations both in the lung

and the nasal mucosa exceeded the MIC

90 of the drug against the target respiratory

pathogens.

Pharmacokinetics of doxycycline after single oral administration to chickens and turkeys

is characterised by a quite rapid and substantial absorption from the gastrointestinal

tract providing peak plasma concentrations between 0.4 and 3.3 hours in chickens and

1.5 to 7.5 hours in turkeys, depending on age and the presence of food. The drug is

widely distributed in the organism with V

d values close to or greater than 1, and exhibits

a shorter elimination half-life in chickens (4.8 to 9.4 hours) than in turkeys (7.9 to 10.8

hours). The protein binding ratio at therapeutic plasma concentrations is in the range of

70-85%. The bioavailability in chickens and turkeys may vary between 41 and 73%, and

25 and 64%, respectively 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 veterinary medicinal product at doses of

20 mg doxycycline/kg (chickens) and 25 mg doxycycline/kg (turkeys) for 5 days the

average plasma concentrations over the whole treatment period were reported as 1.86 ±

0.71 µg/ml in chickens and 2.24 ± 1.02 µg/ml in turkeys. In both avian species the

PK/PD analysis of AUC/MIC

90 data resulted in > 24 h values that meet the

requirements for tetracyclines.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Citric acid anhydrous

6.2 Incompatibilities

In the absence of compatibility studies, this veterinary medicinal product must not be

mixed with other veterinary medicinal products.

Page 5 of 6

Issued October 2016

AN: 00940/2015

6.3 Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 2 years.

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

Shelf life after dilution or reconstitution according to directions: 24 hours.

6.4 Special precautions for storage

Keep the bag tightly closed after first opening in order to protect from moisture.

This veterinary medicinal product does not require any special temperature storage

conditions.

6.5 Nature and composition of immediate packaging

Bag with an outer layer of polyethylene terephthalic acid, middle layers of aluminium and

polyamide and an inner layer of low density polyethylene (PET/ALU/PA/LDPE).

Pack sizes:

Bag of 1 kg

Bag of 2 kg

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 BV

Handelsweg 25

5531 AE Bladel

The Netherlands

8. MARKETING AUTHORISATION NUMBER

Vm 16849/4056

9. DATE OF FIRST AUTHORISATION

21 October 2016

10. DATE OF REVISION OF THE TEXT

October 2016

Approved: 21/10/2016

Page 6 of 6

There are no safety alerts related to this product.

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