Doxylin 50% WSP
Country: Hungary
Language: English
Source: HMA (Heads of Medicines Agencies)
Patient Information leaflet
(PIL)
19-02-2013
Summary of Product characteristics
(SPC)
19-02-2013
Active ingredient:
doxycycline hyclate 500 mg/g
Available from:
Dopharma Research B. V.
ATC code:
QJ01AA02
Pharmaceutical form:
Powder for oral solution
Therapeutic group:
doxycycline
Therapeutic area:
Cattle, Chicken, Pigs
Authorization date:
2012-01-19
Patient Information leaflet
_ _
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
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Summary of Product characteristics
_ _
_ _
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
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