Pulmodox 500 mg/g Granules for Oral Solution for Pigs, Chickens and Turkeys

Summary of Product characteristics

                                Revised: March 2022
Divergence from NI MA following AN: 02798/2021
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Pulmodox 500 mg/g granules for oral solution for pigs, chickens and
turkeys
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
One g granules for oral solution 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
Granules for oral solution.
Yellow, free-flowing granules.
4. CLINICAL PARTICULARS
4.1 TARGET SPECIES
Pigs (fattening pigs after weaning), chickens (broilers, broiler
breeders) and turkeys
(broilers, 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 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.
Revised: March 2022
Divergence from NI MA following AN: 02798/2021
Page 2 of 6
4.5 SPECIAL PRECAUTIONS FOR USE
_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.
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.
A high resistance ra
                                
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