Ország: Portugália
Nyelv: angol
Forrás: HMA (Heads of Medicines Agencies)
doxycycline hyclate 500 mg/g
Dopharma Research B. V.
QJ01AA02
Powder for oral solution
doxycycline
Cattle, Chicken, Pigs
2012-01-19
_ _ LABELLING AND PACKAGE LEAFLET _ _ A. LABELLING _ _SECURITAINER AND BUCKET 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Doxylin 50% WSP, powder for oral solution in pre-ruminant calves, pigs and chickens Doxycycline hyclate 2. STATEMENT OF THE ACTIVE AND OTHER SUBSTANCES Doxycycline hyclate 500 mg/g (equivalent to doxycycline 433 mg/g) 3. PHARMACEUTICAL FORM Powder for oral solution. 4. PACKAGE SIZE 1 kg, 2.5 kg, 5 kg. 5. TARGET SPECIES Pre-ruminant calves, pigs and chickens 6. INDICATION 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_. 7. METHOD AND ROUTE OF ADMINISTRATION Oral use, after dissolution in drinking water/milk repl Olvassa el a teljes dokumentumot
_ _ _ _ SUMMARY OF PRODUCT CHARACTERISTICS _ _ _ _ 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Doxylin 50% WSP, powder for oral solution in pre-ruminant calves, pigs and chickens (BE, BG, NL) Doxylin 50%, powder for oral solution in pre-ruminant calves, pigs and chickens (HU, PT) Doxylin Vet (DK) 500 mg/g (LT), powder for oral solution in pre-ruminant calves, pigs and chickens Doxymed 50, 500 mg/g, powder for oral solution in pre-ruminant calves, pigs and chickens (PL) Doxycycline 50% WSP, powder for oral solution in pre-ruminant calves, pigs and chickens (RO) Doxycycline 50% Dopharma, powder for oral solution in pre-ruminant calves, pigs and chickens (EL) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Per gram: _ACTIVE SUBSTANCE: _ Doxycycline hyclate: 500 mg (equivalent to 433 mg doxycycline) _EXCIPIENTS_: For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for oral solution. Slightly yellowish powder. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Pre-ruminant calves, pigs, chickens. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES 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 Olvassa el a teljes dokumentumot