Description

LADOXYN

NAME OF THE VETERINARY MEDICINAL PRODUCT

Ladoxyn 500 mg/g granules for oral solution for chickens and turkeys

(in Cyprus, Czech Republic, Denmark, Greece, Hungary, Italy, Portugal and Spain)

Pulmodox 500 mg/g granules for oral solution for chickens and turkeys

(in Austria, France, Germany, Slovakia and United Kingdom).

QUALITATIVE AND QUANTITATIVE COMPOSITION

One micro gram granules for oral solution contains:

Active substance:

Doxycycline :500.0 mg, (equivalent to Doxycycline hyclate 580.0 mg)

PHARMACEUTICAL FORM

Granules for oral solution. / Yellow, free-flowing granules.

CLINICAL PARTICULARS

Target species: Chickens (broilers, broiler breeders) and Turkeys (broilers, breeders).

Indications for use, specifying the target species

Chickens and turkeys: treatment of clinical respiratory infections associated with Mycoplasma gallisepticum susceptible to doxycycline.

Contraindications

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

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 hepatic dysfunction.

 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.

 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.

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.

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.

Use during pregnancy, lactation or lay:

Laboratory studies in rats and rabbits have not produced any evidence of a teratogenic, foetotoxic, maternotoxic effects. The safety of the product has not been established in pregnant or lactating sows. The use is not recommended during pregnancy and lactation.Do not use in birds in lay and within 4 weeks before the onset of the laying period.

Dosage:

In chickens:

20.0 mg doxycycline per kg of body weight daily (equivalent to 40.0 mg product per kg of body weight), administered in the drinking water for 5 consecutive days.

In turkeys:

25 mg doxycycline per kg of body weight daily (equivalent to 50.0 mg product per kg of body weight), administered in the drinking water for 5 consecutive days.

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

Nature and composition of immediate packaging:

100 g polypropylene container with polypropylene lid and inner bag of LDPE.

1 kg round polypropylene container with polypropylene lid and inner bag of LDPE.

1 kg square polypropylene container with polypropylene lid and inner bag of LDPE.

5 kg round polypropylene container with polypropylene lid and inner bag of LDPE.

5 kg square polypropylene container with polypropylene lid and inner bag of LDPE

LAVET, Hungary