DOXIVEX, 100 MG/ML, CONCENTRATE FOR ORAL SOLUTION FOR CHICKEN AND PIGS
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
05-05-2024
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Active ingredient:
DOXYCYCLINE
Available from:
SP Veterinaria, S.A.
ATC code:
QJ01AA02
INN (International Name):
DOXYCYCLINE
Dosage:
100 Mg/Ml
Pharmaceutical form:
Oral Solution
Prescription type:
POM
Therapeutic group:
Fowl - Chicken, Porcine
Therapeutic area:
Doxycycline
Therapeutic indications:
Antibacterial
Authorization status:
Authorised
Authorization date:
2007-08-03
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Doxivex, 100 mg/ml concentrate for oral solution for chickens and pigs.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
Quantity of active moiety:
Doxycycline
……………. 100 mg/ml
(equivalent to 115.3 mg/ml of Doxycycline hyclate)
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Concentrate for oral solution.
Clear yellow to dark brown solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Chickens (broilers) and Pigs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Chickens (broilers):
Treatment of colibacillosis, chronic respiratory disease (CRD) and mycoplasmosis caused by microorganisms sensitive
to doxycycline.
Pigs:
PIGS: Treatment of respiratory tract diseases caused by _Pasteurella multocida _(atrophic rhinitis), _Bordetella_
_bronchiseptica _and _Mycoplasma hyopneumoniae _(involved in porcine enzootic pneumonia) sensitive 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
None.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 21/08/2012_
_CRN 7012112_
_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 birds on farm are highly recommended.
A high resistance rate of _E. coli_, isolated from chickens, against tetracyclines has been documented. Therefore the
product should be used for the treatment of infections caused
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