Ladoxyn 500 mg/g granules for oral solution for pigs
Country: Greece
Language: English
Source: HMA (Heads of Medicines Agencies)
Summary of Product characteristics
(SPC)
20-04-2013
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Active ingredient:
doxycycline 500 mg/g
Available from:
Lavet Pharmaceuticals Ltd.
ATC code:
QJ01AA02
Pharmaceutical form:
Granules for oral solution
Therapeutic group:
doxycycline
Therapeutic area:
Pigs
Authorization date:
2011-02-16
Summary of Product characteristics
1
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Ladoxyn 500 mg/g granules for oral solution for pigs, chickens and turkeys
_(in Cyprus, Czech Republic, Denmark, Greece, Hungary, Italy, Portugal and Spain) _
Pulmodox 500 mg/g granules for oral solution for pigs, chickens and turkeys
_(in Austria, France, Germany, Slovakia and United Kingdom) _
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
One g granules for oral solution contains:
ACTIVE SUBSTANCE:
Doxycycline (as hyclate) 500.0 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 parenter
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