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

Χώρα: Ιρλανδία

Γλώσσα: Αγγλικά

Πηγή: HPRA (Health Products Regulatory Authority)

Δραστική ουσία:

Doxycycline hyclate

Διαθέσιμο από:

Eurovet Animal Health B.V.

Φαρμακολογική κατηγορία (ATC):

QJ01AA02

INN (Διεθνής Όνομα):

Doxycycline hyclate

Δοσολογία:

500 milligram(s)/gram

Φαρμακοτεχνική μορφή:

Powder for use in drinking water

Τρόπος διάθεσης:

POM: Prescription Only Medicine as defined in relevant national legislation

Θεραπευτική ομάδα:

Chickens, Pigs, Turkeys

Θεραπευτική περιοχή:

doxycycline

Θεραπευτικές ενδείξεις:

Antibacterial

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2016-10-21

Αρχείο Π.Χ.Π.

Health Products Regulatory Authority
23 July 2021
CRN00C433
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Altidox 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
​
433 mg
(equivalent todoxycycline hyclate 500 mg)
EXCIPIENTS:
For the 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
Pigs (post-weaning), chickens (broilers, pullets, breeders) and
turkeys (broilers, pullets, breeders).
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Pigs: treatment of clinical respiratory infections caused by
_Mycoplasma hyopneumoniae_ and _Pasteurella multocida_ 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 known hypersensitivity to tetracyclines or to
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 impaired liver or kidney function.
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.
4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
The safety of the product has not been established in piglets before
weaning.
Inappropriate use of the product may increase the prevalence of
bacteria resistant to tetracyclines due to the potential for
cross-resistance.
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.
Use of the product should be based o