Review Product Marketing Authorisation For Veterinary Use "vetmedin Vet. Appetibiliper Tablets Dogs».

Original Language Title: Modifica dell'autorizzazione all'immissione in commercio delmedicinale per uso veterinario «Vetmedin vet. compresse appetibiliper cani».

Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-03-09&atto.codiceRedazionale=15A01694&elenco30giorni=false&atto.tipoProvvedimento=DECRETO

Retrieved February 17, 2015 veterinarioVETMEDIN # measure 106 of VET Medicine. palatable tablets for dogs.
Packaging: HDPE from palatable tablets 50 from 1.25 mg-A.I.C. # 104538018;
palatable tablets 1.25 mg 100 HDPE bottle from-A.I.C. # 104538020;
palatable tablets 2.5 mg 50 HDPE bottle from-A.I.C. # 104538032;
palatable tablets 5 mg vial 50 HDPE from-A.I.C. # 104538044;
palatable tablets 10 mg 50 HDPE bottle from-A.I.C. # 104538057.
A.I.C. holder: 55216 Ingelheim BOEHRINGER INGELHEIM VETMEDICA GmbH/Rhein Germany.
The object of the measure: Number: 0006/001-004/AT/V/IB/011.
You authorize the change as described below: added recommendation concerning the processing of the preclinical stage of cardiomyopathy (asymptomatic phase with increased systolic and diastolic diameter Terminal) in Doberman Pinschers after sonographic diagnosis of cardiac disease.
As a result of these changes the RCP and the relevant sections of stampatidevono be amended as follows: RCP: 4.2 indications for use, specifying the target species.
For the treatment of congestive heart failure, due to dilated cardiomyopathy or valvular insufficiency (regurgitation tricuspid and/or mitral valve). (See also section 4.9).
For the treatment of clinical stage of cardiomyopathy (asymptomatic phase with increased systolic and diastolic diameter Terminal) in Doberman Pinschers after sonographic diagnosis of cardiac disease (see section 4.4 and 4.5).
4.4 Special warnings.
The product has not been tested in case of dilated cardiomyopathy (DCM) asymptomatic sustained ventricular tachycardia or atrial fibrillation in Doberman.
4.5 special precautions for use.
Special precautions for use in animals.
During the treatment it is necessary to regularly check the glucose in dogs with concomitant diabetes mellitus.
For the treatment of clinical stage of cardiomyopathy (asymptomatic phase with increased systolic and diastolic diameter Terminal) must be made a full cardiac examination (including echocardiography and possibly Holter monitoring).
It is recommended that the monitoring multiprocessor of cardiac morphology and function in animals treated with pimobendan (see also section 4.6).
Special precautions to be taken by the person administering the veterinary medicinal product to animals.
In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label.
Wash hands after use.
Information for physicians: ingestion, especially in children, can lead to the onset of tachycardia, orthostatic hypotension, facial flushing and headache.
5. pharmacological properties.
Pharmacotherapeutic group: cardiac stimulant excluding cardiac glycosides, Phosphodiesterase inhibitors.
ATCvet Code: QC01CE90.
5.1 pharmacodynamic properties.
When used in cases of valvular regurgitation in association with furosemide, the product has been shown to improve the quality of life and extend life expectancy in treated dogs.
When used in a limited number of symptomatic cases of dilated cardiomyopathy combined with furosemide and digoxin, enalapril, the product has been shown to improve the quality of life and extending life expectancy in treated dogs.
In a randomized study with placebo control group performed with Doberman Pinchers with dilated cardiomyopathy (asymptomatic phase with increased systolic and diastolic diameter Terminal), it has been observed a prolonged onset of congestive heart failure or sudden death and survival time was lengthened in dogs who received pimobendan. In addition, there was a reduction of cardiac volume in dogs treated with pimobendan in the preclinical stage of cardiomyopathy. The evaluation is based on data from 19 (39) and 25 (of 37) dogs that have achieved the primary efficacy endpoint in the group treated with pimobendan and placebo respectively.
Pimobendan, benzimidazole derivative piridazonico, exercises a positive inotrope and possess marked vasodilator properties.
The positive inotropic effect of pimobendan is mediated by two mechanisms of action: increased sensitivity toward the stock of cardiac myofilaments and inhibition of phosphodiesterase III. So positive inotropism is triggered not by an action similar to that of cardiac glycosides or sympathomimetic action. The vasodilatory effect derives from the inhibition of the activity of phosphodiesterase III.
Lots already products may be marketed until their date of expiry.
This abstract will be published in the official journal of the Italian Republic, and its decision will be notified to the undertaking in question.