Advocin porcine 2,5% 100 ml

ADVOCATION

SUMMARY OF PRODUCT CHARACTERISTICS

Active principle:

Danofloxacin mesylate 31,73a mg/ml
Equivalent to 25 mg danofloxacin/ml.
Excipients:
Phenol 2,5 mg as preservative
Other excipients, csp 1 ml

 5. CLINICAL DATA
5.1 Target species
Pigs and cattle, including lactating dairy cows.
5.2 Indications for use
Treatment of respiratory diseases in cattle caused by
Pasteurella haemolytica y P. multocida and treatment of enteric infections
caused by E. coli in cattle.
Treatment of respiratory diseases caused by Pasteurella multocida
y Actinobacillus pleuropneumoniae and treatment of enteric infections
caused by E. coli in swine.
5.3 Contraindications
They have not been described.
5.4 Adverse reactions (frequency and seriousness)
Its intramuscular application can cause irritation at the point of
inoculation.
5.5 Special precautions for use
When using this product, the recommendations should be taken into account.
officials on the use of antimicrobials.
The use of fluoroquinolones should be reserved for the treatment of those
clinical cases that have responded poorly, or are expected to respond
poorly, to other classes of antimicrobials.
Whenever possible, fluoroquinolones should be used after
perform a sensitivity test.
The use of the product in conditions other than those recommended in the Sheet
technique can increase the prevalence of bacteria resistant to
fluoroquinolones and decrease the efficacy of treatment with other quinolones due to
to cross resistances.
Use sterile injection equipment.
5.6 Use during pregnancy and lactation
It can be used in pregnant cows and in lactating cows whose milk is intended for
for human consumption.
The effect of danofloxacin on reproductive function and on pregnancy in
swine, has not been fixed, therefore do not use in these periods.
5.7 Interactions with other medicinal products and other forms of interaction
They have not been described.
5.8 Posology and method of administration
In cattle, ADVOCIN SOLUTION FOR INJECTION can be administered via
intramuscularly, or intravenously at a dose of 1,25 mg of danofloxacin per kg of
live weight (1 ml per 20 kg of live weight). Three treatments with 24
hours apart from each other. Treatment can be extended for an additional period
two days, in animals that have not fully recovered after
three days of initial treatment. For the treatment of bovids that weigh more
from 400 kg, the dose should be divided so that no more than 20 ml is administered
at the same point of application.
In pigs, ADVOCIN SOLUTION FOR INJECTION will be administered via
intramuscularly at a dose of 1,25 mg of danofloxacin per kg of body weight (1 ml per
every 20 kg of live weight). Three treatments 24 hours apart are required
each other. For the treatment of pigs weighing more than 100 kg, the dose should be
divided in such a way that no more than 5 ml are administered at any one point of
application.
5.9 Overdose (symptoms, emergency procedures, antidotes)
In cattle, a safety margin of at least 5 times the
recommended dose for the intramuscular route and 3 times for the intravenous route.
In pigs, with a dose 10 times higher than the recommended one, it appears
reduced mobility, change in stool consistency, depression and
perianal erythema.
5.10 Special warnings for each target species
For the treatment of cattle weighing more than 400 kg, the dose should be divided
so that no more than 20 ml is administered at the same point of application.
For the treatment of pigs weighing more than 100 kg, the dose should be divided
so that no more than 5 ml are administered at the same point of application.
5.11 Timeout
Animals must not be slaughtered for human consumption during the period of
treatment.
Cattle: Meat, intramuscular or intravenous route: 5 days from the last injection
Milk: 48 hours after the last injection.
Pigs: 3 days.
5.12 Specific safety precautions to be taken by the person
who administers or handles the medication
Wash hands after using the medication.
6. PHARMACEUTICAL DATA
6.1 Incompatibilities (important)
They have not been described.
6.2 Period of validity, when necessary after the
reconstitution of the medicinal product or when the first opening of the
container
5 years for closed vials.
Once the vial is opened, the product must be used within 4 weeks.
6.3 Special precautions for storage
Store below 28ºC.
6.4 Nature and contents of container
100 or 250 ml Type II amber rounded glass vial with snap closure
West 4416/50 butylated rubber stopper and lacquered aluminum seal in one
part.
6.5 Special precautions to be observed in disposing of the
unused medication and/or containers
Any unused veterinary medicinal product or residues derived from it
must be disposed of in accordance with current regulations.
7 NAME OR COMPANY NAME AND ADDRESS OR BUSINESS HEADQUARTERS OF THE HOLDER
THE MARKETING AUTHORIZATION
PFIZER SA
Europa Avenue nº 20-B
La Moraleja Business Park
28108 Alcobendas (Madrid). Spain
FINAL INFORMATION
– Marketing authorization number: 1243 ESP- Date of authorization/renewal: February 23, 1999 / April 24,
2007
– Last revision of the text: June 02, 2008.
– Dispensation: Subject to veterinary prescription

ADVOCATION

See technical sheet