Doxylin 500 mg/g, powder for use in drinking water/milk for pre-ruminant calves, pigs and chickens

País: Irlanda

Língua: inglês

Origem: HPRA (Health Products Regulatory Authority)

Ingredientes ativos:

Doxycycline hyclate

Disponível em:

Dopharma Research B.V.

Código ATC:

QJ01AA02

DCI (Denominação Comum Internacional):

Doxycycline hyclate

Forma farmacêutica:

Powder for use in drinking water/milk

Tipo de prescrição:

POM: Prescription Only Medicine as defined in relevant national legislation

Área terapêutica:

doxycycline

Data de autorização:

2023-08-14

Características técnicas

1
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Doxylin 500 mg/g, powder for use in drinking water/milk for
pre-ruminant calves, pigs and chickens
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Per gram:
ACTIVE SUBSTANCE:
Doxycycline hyclate:
500 mg
(equivalent to 433 mg doxycycline)
EXCIPIENTS:
QUALITATIVE
COMPOSITION OF EXCIPIENTS AND
OTHER CONSTITUENTS_ _
Citric acid
Lactose
Slightly yellowish powder.
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Pre-ruminant calves, pigs, chickens.
3.2
INDICATIONS FOR USE FOR EACH TARGET SPECIES
For the treatment of the following specified infections of the
respiratory tract and the alimentary tract
caused by micro-organisms susceptible to doxycycline.
Pre-ruminant calves:
- Bronchopneumonia and pleuropneumonia caused by
_Pasteurella spp_
.,
_Streptococcus spp_
.,
_Arcanobacterium pyogenes_
,
_Histophilus somni_
and
_Mycoplasma spp_
..
Pigs:
- Atrophic rhinitis caused by
_Pasteurella multocida_
and
_Bordetella bronchiseptica_
;
- Bronchopneumonia caused by
_Pasteurella multocida_
,
_Streptococcus suis_
and
_Mycoplasma hyorhinis_
;
- Pleuropneumonia caused by
_Actinobacillus pleuropneumoniae_
.
Chickens:
- Infections of the respiratory tract caused by
_Mycoplasma spp_
.,
_Escherichia coli_
,
_Haemophilus _
_paragallinarum_
and
_Bordetella avium_
;
- Enteritis caused by
_Clostridium perfringens_
and
_Clostridium colinum_
.
3.3
CONTRAINDICATIONS
Do not use in cases of hypersensitivity to tetracyclines or to any of
the excipients.
Do not administer to animals with severe liver- or kidney
insufficiency.
2
3.4
SPECIAL WARNINGS
A high resistance rate of
_E. coli_
, isolated from chickens, against tetracyclines has been documented.
Therefore the veterinary medicinal 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