Doxy 100 %
Country: Germany
Language: English
Source: HMA (Heads of Medicines Agencies)
Patient Information leaflet
(PIL)
10-09-2013
Summary of Product characteristics
(SPC)
10-09-2013
Active ingredient:
doxycycline hyclate 100 %
Available from:
Eurovet Animal Health
ATC code:
QJ01AA02
Pharmaceutical form:
Powder for oral solution
Therapeutic group:
doxycycline
Therapeutic area:
Cattle Young, Pigs Food
Authorization date:
2010-07-28
Patient Information leaflet
PART IB-2
LABELLING SACHETS/BAGS
CENTIDOX 100%
POWDER FOR USE IN DRINKING WATER OR MILK / MILK REPLACER
FOR CALVES AND PIGS
ONE LANGUAGE
THE FULL TEXT WILL BE PRINTED ON THE ALUFOIL SACHET/BAG
FORMAT USED IS REQUIRED BY DUTCH LAW FOR THIS TYPE OF LABELLING
PARTICULARS TO APPEAR ON THE OUTER PACKAGE
+
IMMEDIATE PACKAGE
+
LEAFLET
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Centidox 100%,
powder for use in drinking water or milk / milk replacer for calves and pigs
IT, ES: Centidox 1000
mg/g, powder for use in drinking water or milk / milk replacer for
calves and pigs
Doxycycline hyclate
2.
STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENT
Composition per gram product
Active Substance:
Doxycycline hyclate
1000 mg equivalent to 867 mg/g doxycycline base.
3.
PHARMACEUTICAL FORM
Yellow powder for use in drinking water or milk / milk replacer.
4.
PACKAGE SIZE
100 g, 10x100 gram, 250 g, 500 g, 1 kg,.
5.
TARGET SPECIES
Calves and pigs
6.
INDICATION(S)
Calves and pigs:
Prevention and treatment of respiratory disease caused by _Pasteurella multocida _and
_Mycoplasma spp. _susceptible to doxycycline. The presence of the clinical disease in the herd
should be established before preventive treatment is started.
7.
CONTRAINDICATIONS
Do not use in animals with an active microbiological digestion in the rumen.
Do not use in animals with known hypersensitivity to
tetracyclines.
Do not use in animals with hepatic disorders.
Do not
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Summary of Product characteristics
PART IB-1
SUMMARY OF THE PRODUCT CHARACTERISTICS
CENTIDOX 100%
POWDER FOR USE IN DRINKING WATER
OR MILK / MILK REPLACER
FOR CALVES AND PIGS
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Centidox 100%, powder for use in drinking water or milk / milk replacer for calves and pigs
IT, ES: Centidox 1000 mg/g, powder for use in drinking water or milk / milk replacer for
calves and pigs
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
1 gram of powder contains
ACTIVE SUBSTANCE:
Doxycycline hyclate 1000 mg/g equivalent to 867
mg/g doxycycline base.
EXCIPIENTS:
None
3. PHARMACEUTICAL FORM
Powder for use in drinking water or milk / milk replacer
Yellow powder
4. CLINICAL PARTICULARS
4.1 TARGET SPECIES
Calves and pigs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Calves and pigs:
Prevention and treatment of respiratory disease caused by _Pasteurella multocida _and
_Mycoplasma spp. _susceptible to doxycycline. The presence of the clinical disease in the herd
should be established before preventive treatment is started.
4.3 CONTRAINDICATIONS
Do not use in animals with an active microbiological digestion in the rumen.
Do not use in animals with known hypersensitivity to
tetracyclines.
Do not use in animals with hepatic disorders.
Do not use in animals with renal disorders.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Severely diseased animals have a different drinking pattern and must consequently be treated
parenterally.
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
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