DOXYLIN, 433 MG/G, POWDER FOR USE IN DRINKING WATER FOR CHICKENS AND TURKEYS
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
31-05-2016
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Active ingredient:
DOXYCYCLINE (AS DOXYCYCLINE HYCLATE)
Available from:
Dopharma Research B.V.
ATC code:
QJ01AA02
INN (International Name):
DOXYCYCLINE (AS DOXYCYCLINE HYCLATE)
Dosage:
433 mg/g
Pharmaceutical form:
Powder for use in drinking water
Prescription type:
POM
Therapeutic group:
Fowl - Chicken, Fowl - Turkey
Therapeutic area:
Doxycycline
Therapeutic indications:
Antibacterial
Authorization status:
Authorised
Authorization date:
2015-05-29
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Doxylin, 433 mg/g, powder for use in drinking water for chickens and turkeys
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One gram contains:
_ACTIVE SUBSTANCE:_
Doxycycline:
433.3 mg
(as doxycycline hyclate
500.0 mg)
_EXCIPIENTS_:
For a 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
Chickens (broilers, broiler breeders) and turkeys (broilers, breeders).
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
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 when tetracycline resistance has been detected in the herd/flock due to the potential for cross resistance.
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 16/05/2016_
_CRN 7023499_
_page number: 1_
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Due to variability (time, geographical) in susceptibility of bacteria for doxycycline, bacteriological sampling and
susceptibility testing of micro-organisms from diseased animals on farm are highly recommended.
Inappropriate use of the product may increase the prevalence of bacteria resistant to tetracycline due to the potential for
cros
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