Soludox 500 mg/g powder for use in drinking water for pigs and chickens

국가: 아일랜드

언어: 영어

출처: HPRA (Health Products Regulatory Authority)

유효 성분:

Doxycycline hyclate

제공처:

Eurovet Animal Health B.V.

ATC 코드:

QJ01AA02

INN (International Name):

Doxycycline hyclate

복용량:

500 milligram(s)/gram

약제 형태:

Powder for use in drinking water

처방전 유형:

POM: Prescription Only Medicine as defined in relevant national legislation

치료 그룹:

Chickens, Pigs

치료 영역:

doxycycline

치료 징후:

Antibacterial

승인 상태:

Authorised

승인 날짜:

2018-02-09

제품 특성 요약

Health Products Regulatory Authority
12 February 2018
CRN000W4C
Page 1 of 7
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Soludox 500 mg/g powder for use in drinking water for pigs and
chickens
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 g powder contains:
Active substance:
Doxycycline hyclate 500 mg, corresponding to 433 mg doxycycline
Excipients:
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for use in drinking water.
Yellow crystalline powder.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Pigs and chickens (broiler, pullet, breeder).
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Pigs: For the treatment of the clinical signs associated with porcine
respiratory
disease caused by _Actinobacillus pleuropneumoniae_, _Pasteurella
multocida_, and
_Mycoplasma hyopneumoniae_ susceptible to doxycycline.
Chickens: Where clinical disease is present in the flock, to reduce
mortality, morbidity,
clinical signs and to reduce lesions due to Pasteurellosis caused by
_Pasteurella _
_multocida_, or to reduce morbidity and lesions due to respiratory
infections caused by
_Ornithobacterium rhinotracheale_ (ORT).
4.3 CONTRAINDICATIONS
Do not use in cases of hypersensitivity to the active substance or to
any of the
excipients.
Do not use in animals with an impaired liver function.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
Health Products Regulatory Authority
12 February 2018
CRN000W4C
Page 2 of 7
4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Due to likely variability (time, geographical) in susceptibility of
bacteria to
doxycycline, especially susceptibility of A. _pleuropneumoniae_ and O.
_rhinotracheale_
which may differ from country to country and even farm to farm,
bacteriological
sampling and susceptibility testing are recommended. Use of the
product should be
based on the culture and sensitivity of micro-organisms from diseased
cases on
farms. If this is not possible, therapy should be based on local
(regional, farm level)
epidemiological information about su