Doxivex, 100 mg/ml concentrate for oral solution for chickens and pigs

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Doxycycline hyclate

Available from:

Duggan Veterinary Supplies Limited

ATC code:

QJ01AA02

INN (International Name):

Doxycycline hyclate

Pharmaceutical form:

Oral solution

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

doxycycline

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
None.
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 by
_E. _
_coli _
only after susceptibility testing has been carried out.
As eradication of the target pathogens may not be achieved, medication
should therefore be
combined
with
good
management
practices,
e.g.
good
hygiene,
proper
ventilation,
no
overstocking.
Avoid administration in oxidised troughs
Inappropriate use of the product, e.g. too low a dosage, may increase
the prevalence of bacteria
resist