Powdox Doxycycline 500 mg/g powder for use in drinking water for pigs, chickens and turkeys

Maa: Irlanti

Kieli: englanti

Lähde: HPRA (Health Products Regulatory Authority)

Aktiivinen ainesosa:

Doxycycline

Saatavilla:

Vetpharma Animal Health, S.L.

ATC-koodi:

QJ01AA02

INN (Kansainvälinen yleisnimi):

Doxycycline

Annos:

500 milligram(s)/gram

Lääkemuoto:

Powder for use in drinking water

Prescription tyyppi:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapeuttinen ryhmä:

Chickens, Pigs, Turkeys

Terapeuttinen alue:

doxycycline

Käyttöaiheet:

Antibacterial

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2013-01-25

Valmisteyhteenveto

Health Products Regulatory Authority
27 October 2017
CRN000VG0
Page 1 of 8
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Powdox Doxycycline 500 mg/g powder for use in drinking water for pigs,
chickens
and turkeys
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each g contains:
​
​
ACTIVE SUBSTANCE:
​
​
Doxycycline
​
500.0 mg
​
(equivalent to doxycycline hyclate 580.0 mg)
​
​
Excipients:
​
For the full list of excipients, see section 6.1
​
3 PHARMACEUTICAL FORM
Powder for use in drinking water.
Yellowish powder.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Pigs for fattening, chickens (broilers, chicken for reproduction) and
turkeys (broilers,
turkeys for reproduction).
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Pigs: treatment of clinical respiratory infections caused by
_Mycoplasma _
_hyopneumoniae _and _Pasteurella multocida _strains susceptible to
doxycycline.
Chickens and turkeys: treatment of clinical respiratory infections
associated with
_Mycoplasma gallisepticum _susceptible to doxycycline.
4.3 CONTRAINDICATIONS
Do not use in cases of hypersensitivity to the active substance or to
any excipient.
Do not use in animals with hepatic dysfunction.
Health Products Regulatory Authority
27 October 2017
CRN000VG0
Page 2 of 8
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
The uptake of medication by animals can be altered as a consequence of
illness. In
case of insufficient uptake of drinking water, animals should be
treated parenterally.
Under-dosing and/or treating for an insufficient length of time are
considered to
promote the development of resistance in bacteria and should be
avoided.
4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Inappropriate use of the product may increase the prevalence of
bacteria resistant to
tetracycline due to the potential for cross resistance.
Use of the product should be based on susceptibility testing of the
bacteria isolated
from the animal. If this is not possible, therapy should be based on
local (regional,
farm level) epidemiological