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

Negara: Irlandia

Bahasa: Inggris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Doxycycline hyclate

Tersedia dari:

Eurovet Animal Health B.V.

Kode ATC:

QJ01AA02

INN (Nama Internasional):

Doxycycline hyclate

Dosis:

500 milligram(s)/gram

Bentuk farmasi:

Powder for use in drinking water

Jenis Resep:

POM: Prescription Only Medicine as defined in relevant national legislation

Kelompok Terapi:

Chickens, Pigs

Area terapi:

doxycycline

Indikasi Terapi:

Antibacterial

Status otorisasi:

Authorised

Tanggal Otorisasi:

2018-02-09

Karakteristik produk

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