natgillin/translations-raw huggingface dataset:
Mild and transient gastrointestinal effects such as vomiting and diarrhoea have been reported to occur very rarely based on post-marketing safety experience.
Glede na post-marketinške izkušnje na področju varnosti zdravila so zelo redko poročali o blagih in prehodnih želodčno-črevesnih motnjah, kot sta bruhanje in diareja.
for cats (0.5-2.0 kg) for cats (>2-8.0 kg)
za mačke (0,5-2,0 kg) za mačke (> 2-8,0 kg)
1 tablet 3 tablets 6 tablets
6 tablet
All safety and efficacy data have been acquired from dogs and puppies 8 weeks of age and older and 1.3 kg of body weight and greater.
Vsi podatki o varnosti in učinkovitosti so bili pridobljeni pri psih in pasjih mladičih, starih 8 tednov ali več in s telesno maso 1,3 kg ali več.
ADVICE ON CORRECT ADMINISTRATION Administer the veterinary medicinal product with food or within 30 minutes after feeding.
NASVET O PRAVILNI UPORABI ZDRAVILA Zdravilo za uporabo v veterinarski medicini dajte s hrano ali v 30 minutah po hranjenju.
Fleas and ticks must attach to the host and commence feeding in order to be exposed to the active substance.
Bolhe in klopi so izpostavljeni učinkovini šele, ko se prisesajo na gostitelja in se začnejo hraniti.
Credelio is a palatable chewable flavoured tablet.
Zdravilo Credelio je okusna žvečljiva tableta z dodano aromo.
EU/2/17/206/014 (900 mg lotilaner; 3 chewable tablets) EU/2/17/206/015 (900 mg lotilaner; 6 chewable tablets)
EU/2/17/206/013 (900 mg lotilanerja; 1 žvečljiva tableta) EU/2/17/206/014 (900 mg lotilanerja; 3 žvečljive tablete) EU/2/17/206/015 (900 mg lotilanerja; 6 žvečljivih tablet)
Administer the veterinary medicinal product with food or within 30 minutes after feeding.
Zdravilo za uporabo v veterinarski medicini dajte s hrano ali v 30 minutah po hranjenju.
Use an appropriate combination of available strengths to achieve the recommended dose of 2043 mg/kg.
Uporabite ustrezno kombinacijo razpoložljivih jakosti tablet, da dosežete priporočeni odmerek 20-43
Safety and efficacy data has been studied in cats aged 8 weeks and older with a body weight of 0.5 kg or more.
Podatki o varnosti in učinkovitosti so bili pridobljeni pri mačkah, starih 8 tednov ali več in s telesno maso 0,5 kg ali več.
Existing ticks on the animal prior to administration are killed within 18 hours.
Klopi, ki so prisesani že pred dajanjem zdravila, so uničeni v 18 urah.
Body weight of dog (kg)
Telesna masa psa (kg)
White to beige round chewable tablets with brownish spots.
Bele do rjavkaste okrogle žvečljive tablete z rjavkastimi pikami.
All safety and efficacy data have been acquired from cats and kittens 8 weeks of age and older and 0.5 kg of body weight and greater.
Vsi podatki o varnosti in učinkovitosti so bili pridobljeni pri mačkah in mačjih mladičih, starih 8 tednov ali več in s telesno maso 0,5 kg ali več.
Blisters (dogs)
Pretisni omot (psi)
NAME OF THE MARKETING AUTHORISATION HOLDER
IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Elanco
Lotilaner, a pure enantiomer from the isoxazoline class is active against fleas (Ctenocephalides felis and Ctenocephalides canis) as well as the tick species Dermacentor reticulatus, Ixodes hexagonus, Ixodes ricinus and Rhipicephalus sanguineus.
Ctenocephalides canis) ter klopom Dermacentor reticulatus, Ixodes hexagonus, Ixodes ricinus in Rhipicephalus sanguineus.
Lotilaner, a pure enantiomer from the isoxazoline class, is active against fleas (Ctenocephalides felis and Ctenocephalides canis) and ticks (Ixodes ricinus).
Lotilaner, čisti enantiomer iz razreda izoksazolinov, učinkuje proti bolham (Ctenocephalides felis in
In in vitro studies, the activity of lotilaner against some arthropod species was not affected by resistance to organochlorines (cyclodienes, e.g. dieldrin), phenylpyrazoles (e.g. fipronil), neonicotinoids (e.g. imidacloprid), formamidines (e.g. amitraz) and pyrethroids (e.g. cypermethrin).
V in vitro študijah odpornost proti organoklornim spojinam (ciklodieni, npr. dieldrin), fenilpirazolom (npr. fipronil), neonikotinoidom (npr. imidakloprid), formamidinom (npr. amitraz) in piretroidom (npr. cipermetrin) ni vplivala na delovanje lotilanerja proti nekaterim vrstam členonožcev.
PACKAGE LEAFLET: Credelio 12 mg chewable tablets for cats (0.5-2.0 kg) Credelio 48 mg chewable tablets for cats (>2.0-8.0 kg)
Credelio 12 mg žvečljive tablete za mačke (0,5-2,0 kg) Credelio 48 mg žvečljive tablete za mačke (> 2,0-8,0 kg)
Fleas on the animal prior to administration are killed within 6 hours.
Bolhe, ki so prisesane že pred dajanjem zdravila, so uničene v 6 urah.
No adverse reactions were observed following oral administration to puppies aged 8-9 weeks and weighing 1.3-3.6 kg treated with overdoses of up to 5 times the maximum recommended dose (43 mg, 129 mg and 215 mg lotilaner/kg bodyweight) on eight occasions at monthly intervals.
Po peroralnem dajanju prevelikih odmerkov, ki so do petkrat presegali največji priporočeni odmerek (43 mg, 129 mg in 215 mg lotilanerja/kg telesne mase), pasjim mladičem, starim 8-9 tednov in s telesno maso 1,3-3,6 kg, osemkrat v mesečnih presledkih, niso opazili nobenih neželenih učinkov.
Credelio 56 mg chewable tablets for dogs (1.3-2.5 kg) Credelio 112 mg chewable tablets for dogs (>2.5-5.5 kg) Credelio 225 mg chewable tablets for dogs (>5.5-11 kg) Credelio 450 mg chewable tablets for dogs (>11-22 kg) Credelio 900 mg chewable tablets for dogs (>22-45 kg)
Credelio 56 mg žvečljive tablete za pse (1,3-2,5 kg) Credelio 112 mg žvečljive tablete za pse (> 2,5-5,5 kg) Credelio 225 mg žvečljive tablete za pse (> 5,5-11 kg) Credelio 450 mg žvečljive tablete za pse (> 11-22 kg) Credelio 900 mg žvečljive tablete za pse (> 22-45 kg)
Use of this veterinary medicinal product in puppies younger than 8 weeks of age or less than 1.3 kg of body weight should be based on a benefit-risk assessment by the responsible veterinarian.
To zdravilo za uporabo v veterinarski medicini uporabite pri pasjih mladičih, mlajših od 8 tednov ali s telesno maso, manjšo od 1,3 kg, le v skladu z oceno razmerja korist-tveganje odgovornega veterinarja.
Cellulose, powdered Lactose monohydrate Silicified microcrystalline cellulose Meat dry flavour
6.1 Seznam pomožnih snovi celuloza, uprašena laktoza monohidrat silicifirana mikrokristalna celuloza aroma suhega mesa krospovidon povidon K30 natrijev lavrilsulfat silicijev dioksid, koloidni, brezvodni magnezijev stearat
The safety of the veterinary medicinal product in breeding dogs has not been established.
Varnost zdravila za uporabo v veterinarski medicini pri psih, namenjenih za vzrejo, ni bila dokazana.
Treatment of flea and tick infestations in dogs.
INDIKACIJA(E) Zdravljenje infestacij z bolhami in klopi pri psih.
For the treatment of flea and tick infestations on cats.
INDIKACIJA(E) Zdravljenje infestacij z bolhami in klopi pri mačkah.
The activity of lotilaner was not affected by resistance to organochlorines (cyclodienes, e.g. dieldrin), phenylpyrazoles (e.g. fipronil), neonicotinoids (e.g. imidacloprid), formamidines (e.g. amitraz) and pyrethroids (e.g. cypermethrin).
dieldrin), fenilpirazolom (npr. fipronil), neonikotinoidom (npr. imidakloprid), formamidinom (npr. amitraz) in piretroidom (npr. cipermetrin) ni vplivala na delovanje lotilanerja.
Silicified microcrystalline cellulose Cellulose, powdered Lactose monohydrate Povidone K30
6.1 Seznam pomožnih snovi kvas v prahu (aroma) silicifirana mikrokristalna celuloza celuloza, uprašena laktoza monohidrat povidon K30 krospovidon natrijev lavrilsulfat vanilin (aroma) silicijev dioksid, koloidni, brezvodni magnezijev stearat
10 DATE OF REVISION OF THE TEXT DD/MM/YYYY
DD/MM/LLLL
Fleas on the animal prior to administration are killed within 8 hours.
Bolhe, ki so prisesane že pred dajanjem zdravila, so uničene v 8 urah.
Use of this veterinary medicinal product in kittens younger than 8 weeks of age or less than 0.5 kg of body weight should be based on a benefit-risk assessment by the responsible veterinarian.
To zdravilo za uporabo v veterinarski medicini uporabite pri mačjih mladičih, mlajših od 8 tednov ali s telesno maso, manjšo od 0,5 kg, le v skladu z oceno razmerja korist-tveganje odgovornega veterinarja.
PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard box (dogs)
PODATKI NA ZUNANJI OVOJNINI Kartonska škatla (psi)
For ticks, the onset of efficacy is within 48 hours of attachment for one month after product administration.
Proti klopom začne zdravilo učinkovati v 48 urah po tem, ko se zajedavec prisesa na žival, in učinkuje en mesec po dajanju zdravila.
PHARMACEUTICAL FORM Chewable tablet.
Žvečljiva tableta.
The safety of the veterinary medicinal product in cats has not been established during pregnancy and lactation.
Varnost zdravila za uporabo v veterinarski medicini pri mačkah v obdobju brejosti in laktacije ni bila dokazana.
For fleas, the onset of efficacy is within 12 hours of attachment for one month after product administration.
Proti bolham začne zdravilo učinkovati v 12 urah po tem, ko se zajedavec prisesa na žival, in učinkuje en mesec po dajanju zdravila.
For cats of more than 8 kg body weight, use an appropriate combination of available strengths to achieve the recommended dose of 6-24 mg/kg.
Ustrezna kombinacija tablet Pri mačkah s telesno maso, večjo od 8 kg, uporabite ustrezno kombinacijo razpoložljivih jakosti tablet,
This veterinary medicinal product provides immediate and persistent killing activity for 1 month for fleas (Ctenocephalides felis and C. canis) and ticks (Rhipicephalus sanguineus, Ixodes ricinus, I. hexagonus, and Dermacentor reticulatus).
(Ctenocephalides felis in C. canis) ter klope (Rhipicephalus sanguineus, Ixodes ricinus, I. hexagonus in Dermacentor reticulatus), ki traja 1 mesec.
For ticks, the onset of efficacy is within 24 hours of attachment for one month after product administration.
Proti klopom začne zdravilo učinkovati v 24 urah po tem, ko se zajedavec prisesa na žival, in učinkuje en mesec po dajanju zdravila.
No adverse reactions were observed following oral administration to kittens aged 8 weeks and weighing 0.5 kg treated with overdoses of more than 5 times the maximum recommended dose rate (130 mg lotilaner/kg bodyweight) on eight occasions at monthly intervals.
Po peroralnem dajanju prevelikih odmerkov, ki so več kot petkrat presegali največji priporočeni odmerek (130 mg lotilanerja/kg telesne mase), mačjim mladičem, starim 8 tednov in s telesno maso
Special precautions to be taken by the person administering the veterinary medicinal product to animals:
Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo: Po uporabi zdravila si umijte roke.
For fleas, the onset of efficacy is within 4 hours of attachment for one month after product administration.
Proti bolham začne zdravilo učinkovati v 4 urah po tem, ko se zajedavec prisesa na žival, in učinkuje en mesec po dajanju zdravila.
The safety of the veterinary medicinal product in breeding, pregnant and lactating dogs has not been established.
Varnost zdravila za uporabo v veterinarski medicini pri psih, namenjenih za vzrejo, ter psicah v obdobju brejosti in laktacije ni bila dokazana.
The safety of the veterinary medicinal product in breeding queens has not been established.
Varnost zdravila za uporabo v veterinarski medicini pri mačjih samicah, namenjenih za vzrejo, ni bila dokazana.
This veterinary medicinal product provides immediate and persistent killing activity for 1 month against fleas (Ctenocephalides felis and C. canis) and ticks (Ixodes ricinus).
5.1 Farmakodinamične lastnosti Lotilaner, čisti enantiomer iz razreda izoksazolinov, učinkuje proti bolham (Ctenocephalides felis in
For the treatment of flea and tick infestations in dogs.
4.2 Indikacije za uporabo pri ciljnih živalskih vrstah Zdravljenje infestacij z bolhami in klopi pri psih.
• The Committee considered the referral under Article 31 of Directive 2001/83/EC;
• Odbor je obravnaval napotitev v skladu s členom 31 Direktive 2001/83/ES.
In 24.3% of cases, the indication was unknown.
V 24,3 % primerov indikacija ni bila znana.
These results were pooled without confirming the beneficial effect .
Ti rezultati so bili združeni brez potrditve ugodnih učinkov.
These pathologies lead ultimately to blindness.
Te patologije na koncu privedejo do slepote.
Otology - Ear, Nose and Throat (ENT)
Otologija - ušesa, nos in grlo (ORL)
Finally, the most recent study using an appropriate methodology was submitted only for safety purpose as the efficacy objective was not reached (France ARMD 2, 2008).
Končno, najnovejša študija, v kateri so uporabljali ustrezno metodologijo, je bila predložena le za namene varnosti, saj cilj učinkovitosti ni bil dosežen (Francija ARMD 2, 2008).
Each study generally included multiple objectives (pharmacodynamic or clinical evaluations).
Vsaka študija je na splošno zajemala več ciljev (farmakodinamičnih ali kliničnih ocenitev).
Trimetazidine medicinal products have been authorised in 21 European Member states.
Zdravila, ki vsebujejo trimetazidin, so odobrena v 21 državah članicah Evropske unije.
The analysis performed by the MAH has been repeated independently by the Italian Institutes of Health (ISS).
Analizo, ki jo je opravil imetnik dovoljenja za promet z zdravilom, je neodvisno ponovil Italijanski zdravstveni inštitut (ISS - Italian Institutes of Health).
Overall summary of the scientific evaluation of trimetazidine containing medicinal products (see Annex I)
Splošni povzetek znanstvenega vrednotenja zdravil, ki vsebujejo trimetazidin (glejte Prilogo I)
In doubtful cases, patients should be referred to a neurologist for appropriate investigations.
V primeru dvoma je treba bolnike napotiti k nevrologu na ustrezne preiskave.
It should be noted that the study was conducted using the Bruce protocol that it is known to underestimate the treatment effect of drugs compared to the modified Bruce protocol.
Opozoriti je treba, da je bila študija opravljena z Bruceovim protokolom, za katerega je znano, da podcenjuje učinke zdravljenja z zdravili v primerjavi s prilagojenim Bruceovim protokolom.
Of the ten studies submitted, nine do not apply the relevant methodological principles currently required to demonstrate efficacy.
Od desetih predloženih študij jih devet ne uporablja ustreznih metodoloških načel, ki so potrebna za dokazovanje učinkovitosti.
Among these studies, five studies were conducted against placebo including the additional study published in 1990 by Coyas.
Med temi študijami je bilo pet študij izvedenih s placebom, vključno z dodatno študijo, ki jo je leta 1990 objavil Coyas.
Therefore, the results which were presented as supporting a similar efficacy than trimetazidine are not reliable.
Zato rezultati, predstavljeni v podporo podobni učinkovitosti, kot jo ima trimetazidin, niso zanesljivi.
In addition, Vitte study (2002) had the same methodological weaknesses as the Wayoff and Morgon studies.
Tudi študija Vitte (2002) je vsebovala enake metodološke šibkosti kot študiji Wayoff in Morgon.
These changes are considered adequate to manage the risk of pakinsonian symptoms and tremors.
Te spremembe se smatrajo za zadostne za upravljanje s tveganjem simptomov pakinsonove bolezni in tremorjev.
The study results may thus be considered conservative in terms of magnitude of the effect of trimetazidine.
Rezultati študije se lahko zato obravnavajo kot konservativni v smislu obsega učinka trimetazidina.
The clinical experience with trimetazidine dates back to the early 70s.
Klinične izkušnje s trimetazidinom segajo v zgodnja sedemdeseta leta.
Trimetazidine has no hemodynamic effect on blood pressure or heart rate.
Trimetazidin nima hemodinamskega učinka na krvni tlak ali srčni utrip.
The new proposed wording in the angina pectoris indication is in accordance with the available efficacy and safety data assessed.
Novo predlagano besedilo za indikacijo angine pektoris je v skladu z ocenjenimi razpoložljivimi podatki o učinkovitosti in varnosti.
France on 22 April 2011 requested the CHMP to give its opinion under Article 31 of Directive 2001/83/EC on whether the marketing authorisation for trimetazidine-containing medicinal products should be maintained, varied, suspended or withdrawn on the basis of the increased Parkinson's reports.
Dne 22. aprila 2011 je Francija CHMP zaprosila za mnenje v skladu s členom 31 Direktive 2001/83/ES o tem, ali naj se dovoljenje za promet z zdravili, ki vsebujejo trimetazidin, ohrani, spremeni, začasno odvzame ali umakne zaradi vse več poročil o parkinsonovi bolezni.
The CHMP considered all the studies submitted for this indication.
CHMP je za to indikacijo upošteval vse predložene študije.
The efficacy of trimetazidine was also summarised in a recent network meta-analysis including 358 clinical trials and 27058 patients.
Učinkovitost trimetazidina je povzeta tudi v nedavni omrežni metaanalizi, v katero je bilo vključenih 358 kliničnih preskušanj in 27 058 bolnikov.
A significant difference was also evidenced for the time to onset of angina pectoris (p=0.049).
Pomembna razlika se je pokazala tudi v času do pojava angine pektoris (p = 0,049).
The majority of the patients who recovered, had their symptoms disappeared within four months after trimetazidine withdrawal.
Pri večini bolnikov, ki so okrevali, so simptomi izginili v roku štirih mesecev po prenehanju uporabe trimetazidina.
Less than 50% of patients included in the VASCO study had chronic stable angina despite probable coronary artery disease.
Manj kot 50 % bolnikov, vključenih v študijo VASCO, je imelo kronično stabilno angino pektoris, kljub verjetni koronarni arterijski bolezni.
None of these three studies was predefined as non-inferiority study.
Nobena od teh treh študij ni bila vnaprej označena kot študija enakovrednosti.
Of note, all the data submitted and assessed for this referral are newly available data since the first authorisation of trimetazidine.
Opozoriti je treba, da so vsi podatki, predloženi in ocenjeni v tej napotitvi, na novo razpoložljivi podatki od prve odobritve trimetazidina.
They were first authorised in France in 1978 and are available in three different pharmaceutical forms in the EU: 20 mg tablet, 20 mg/ml oral solution and 35 mg modified release (MR) tablet.
Najprej so bila odobrena v Franciji leta 1978 in so v EU na voljo v treh različnih farmacevtskih oblikah: 20 mg tablete, 20 mg/ml peroralna raztopina in 35 mg tablete s prirejenim sproščanjem.
These cases have a low prevalence and are usually reversible after treatment discontinuation.
Ti pojavi so redki in običajno reverzibilni po prekinitvi zdravljenja.
The CHMP concluded that following the assessment of all these studies the efficacy of trimetazidine is not proven on the ophthalmological indication.
CHMP je zaključil, da po oceni vseh teh študij učinkovitost trimetazidina za oftalmološko indikacijo ni dokazana.
Furthermore, these studies present other specific weaknesses: the Cordella study (versus cinnarizine) did not include inter-group comparison.
V teh študijah so bile tudi druge specifične pomanjkljivosti: študija Cordella (v primerjavi s cinarizinom) ni vključevala primerjave med skupinami.
Based on the data submitted for the ophthalmologic indications, the CHMP considered that the evidence does not fulfill the requirements and criteria for the evaluation of efficacy currently requested in these pathologies.
Na podlagi podatkov, predloženih za oftalmološke indikacije, je CHMP menil, da dokazi ne izpolnjujejo zahtev in kriterijev za ocenitev učinkovitosti, ki se trenutno zahtevajo za te patologije.
Its mechanism of action results partly of its effect on cellular metabolism.
Mehanizem delovanja je delno posledica učinka na celično presnovo.
The non-comparative nature of three studies conducted in patients with heterogeneous ocular disorders, did not allow concluding to the existence of a clinical benefit.
Neprimerjalna narava treh študij, opravljenih pri bolnikih s heterogenimi boleznimi oči, ni omogočala sklepanja na obstoj kliničnih koristi.
A prescription study in France showed that trimetazidine was prescribed in patients in cardiovascular indications in 45.3% of cases, in ENT indications in 30% of cases and in ophthalmological indications in 0.4% of cases.
Študija predpisovanja v Franciji je pokazala, da so trimetazidin predpisovali bolnikom za kardiovaskularne indikacije v 45,3 % primerov, za ORL indikacije v 30 % primerov in za oftalmološke indikacije v 0,4 % primerov.
The VASCO study was conducted in symptomatic and asymptomatic patients with chronic ischemic heart disease.
Študijo VASCO so izvedli pri simptomatskih in asimptomatskih bolnikih s kronično ishemično boleznijo srca.
The most recent study conducted with trimetazidine 35 mg from 1999 (France, ARMD 2) related to a higher number of patients monitored for 3 to 5 years.
Najnovejša študija, izvedena s trimetazidinom 35 mg iz leta 1999 (Francija, ARMD 2), zajema večje število bolnikov, ki so jih spremljali 3 do 5 let.
The CHMP endorsed a communication, Direct Healthcare Professional Communication (DHPC), to communicate the outcome of the present review.
CHMP je odobril neposredno obvestilo zdravstvenim delavcem (Dear Healthcare Professional Communication, DHPC), da se jim sporoči izid tega pregleda.
The reporting rate of Parkinson's syndrome plausibly related to trimetazidine is stable over time since the last 8 years, despite the increase, since 2007, in the number of spontaneous reports of Parkinson's syndrome and related symptoms.
Stopnja poročanja parkinsonovega sindroma, ki je najverjetneje povezana s trimetazidinom, je v zadnjih 8 letih stabilna,kljub povečanju števila spontanih poročil parkinsonovega sindroma in povezanih simptomov od leta 2007.
The presence of stable angina pectoris is a pivotal inclusion criterion as it identifies the target population for the use of anti-anginal drugs.
Prisotnost stabilne angine pektoris je osrednji vključitveni kriterij, saj opredeljuje ciljno populacijo za uporabo zdravil proti angini pektoris.
If parkinsonian symptoms persist more than four months after drug discontinuation, a neurologist opinion should be sought.
Če simptomi parkinsonove bolezni več kot štiri mesece po prekinitvi uporabe zdravila ne izginejo, se je treba posvetovati z nevrologom.
Two additional and more recent studies were focused on dizziness but the exploratory nature of the Sterkers study (2001) and the extremely small populations included (28 patients) do not make it possible to give any demonstrative weight to the results reported.
Dve dodatni, pred kratkim opravljeni študiji, sta se osredotočili na vrtoglavico, vendar raziskovalna narava študije Sterkers (2001) in izjemno majhna vključena populacija (28 bolnikov) poročanim rezultatom ne dajeta nobene dokazne teže.
The studies suggested limited methodology in the ENT field and do not confirm the current methodology of investigation by applying the basic statistical principles of clinical trials methodology.
Študije kažejo na omejeno metodologijo na področju ORL in ne potrjujejo trenutne raziskovalne metodologije, ki uporablja osnovna statistična načela za metodologijo v kliničnih preskušanjih.
However, the TRIMPOL-II study (2001), the study by Sellier (2003) and the revised data from the VASCO study (2011) were the studies providing evidence generated in support of the add-on indication of trimetazidine in symptomatic patients with angina pectoris.
Vendar pa so študija TRIMPOL-II (2001), študija, ki jo je opravil Sellier (2003), in revidirani podatki študije VASCO (2011) tiste študije, iz katerih so razvidni dokazi v podporo dodatni indikaciji trimetazidina pri simptomatskih bolnikih z angino pektoris.
The most exposed population based on sales data, is patients aged more than 75 years old, and they received the treatment for very long periods mainly in cardiology indications.
Na podlagi podatkov o prodaji je najbolj izpostavljena populacija bolnikov, starih več kot 75 let, ki so se zelo dolgo zdravili, pretežno za kardiološke indikacije.
They also mixed ENT pathologies and symptomatologies from different etiologies such as tinnitus, different kinds of vertigo or deafness.
Mešali so tudi patologije ORL in simptomatiko različnih etiologij, kot so tinitus, različne vrste vrtoglavice ali gluhota.