POWDOX DOXYCYCLINE 500 MG/G ORAL POWDER FOR USE IN
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
18-01-2017
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Active ingredient:
DOXYCYCLINE (AS DOXYCYCLINE HYCLATE)
Available from:
Vetpharma Animal Health, S.L.
ATC code:
QJ01AA02
INN (International Name):
DOXYCYCLINE (AS DOXYCYCLINE HYCLATE)
Dosage:
500(580) mg/g
Pharmaceutical form:
Granules for oral solution
Prescription type:
POM
Therapeutic group:
Fowl - Chicken, Fowl - Turkey, Porcine
Therapeutic area:
Doxycycline
Therapeutic indications:
Antibacterial
Authorization status:
Authorised
Authorization date:
2013-01-25
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
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
One gram contains:
ACTIVE SUBSTANCE:
Doxycycline 500.0 mg
(equivalent to Doxycycline hyclate 580.0 mg)
For a 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 (fattening pigs after weaning), chickens (broilers, broilers breeders) and turkeys (broilers, breeders).
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Pigs (fattening pigs after weaning): treatment of clinical respiratory infections caused by _Mycoplasma hyopneumoniae_
and _Pasteurella multocida _susceptible to doxycycline.
Chickens (broilers, broiler breeders) and turkeys (broilers, breeders): treatment of clinical respiratory infections
associated with _Mycoplasma gallisepticum _susceptible to doxycycline.
4.3 CONTRAINDICATIONS
Do not use in case of hypersensitivity to the active substance or to any of the excipients.
Do not use in animals with hepatic dysfunction.
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.
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 03/01/2017_
_CRN 7025387_
_page number: 1_
4.5 SPECIAL PRECAUTIONS FOR USE
i. 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 ba
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