FrancophonIA/ELRC3.0 huggingface dataset:
English: The frequency of severe cough events was also higher in TIP group (2.6% versus 1.9%).
Croatian: Učestalost pojave teškoga kašlja također je bila veća u skupini koja je uzimala TIP (2,6 % u odnosu na 1,9 %).
English: • The Committee therefore considered that, in the context of Article 8(3) of Regulation (EC) No 141/2000, clinical superiority of Tobramycin VVB over TOBI Podhaler in a substantial portion of the target population can be established.
Croatian: • Odbor je stoga smatrao da je, u kontekstu članka 8. stavka 3. Uredbe (EZ) br. 141/2000, moguće ustanoviti kliničku nadmoć lijeka Tobramycin VVB u odnosu na lijek TOBI Podhaler u znatnom udjelu ciljne populacije.
English: The Applicant's claim for clinical superiority based on greater safety (tolerability) of tobramycin nebulizer solution (TIS) over tobramycin inhalation powder (TIP) in a substantial portion of the target population relies on clinical data generated by the open-label EAGER study1 and its post hoc analyses2.
Croatian: Tvrdnja podnositelja zahtjeva u odnosu na kliničku nadmoć na temelju veće sigurnosti (podnošljivosti) otopine za nebulizator tobramycin (TIS) u odnosu na prašak za udisanje tobramycin (TIP) u velikom udjelu ciljne populacije oslanja se na kliničke podatke prikupljene u otvorenom ispitivanju EAGER1 te u analizama post hoc2.
English: Overall, in the context of the claim of clinical superiority based on a greater safety according to Article 8(3)(c) of Regulation (EC) No 141/2000 read in combination with Article 3(3)(d)(2) of Regulation (EC) No 847/2000, CHMP considered that a substantial portion of the target population experiences greater safety (in terms of tolerability) with Tobramycin VVB in terms of the incidence of cough and treatment discontinuation, as compared to TOBI Podhaler.
Croatian: Sveukupno gledano, a u kontekstu tvrdnje o kliničkoj nadmoći na temelju veće sigurnosti u skladu s člankom 8. stavkom 3. točkom (c) Uredbe (EZ) br. 141/2000 koja se uzima u obzir zajedno s člankom 3. stavkom 3. točkom (d) podtočkom (2) Uredbe (EZ) br. 847/2000, CHMP je smatrao da znatan udio ciljne populacije doživljava veću sigurnost (u smislu podnošljivosti) s lijekom Tobramycin VVB u smislu pojave kašlja i prekida liječenja u usporedbi s lijekom TOBI Podhaler.
English: The higher cough rate observed with TOBI Podhaler may be due to a higher powder deposition in the throat in comparison to nebuliser products.
Croatian: Podhaler mogla bi biti posljedica većeg taloženja praška u grlu u odnosu na proizvode za nebulizator.
English: For these patients, tobramycin nebuliser solution is an alternative.
Croatian: Tim bolesnicima alternativa je otopina tobramicina za nebulizator.
English: Other treatment-related AEs more commonly reported in the TIP group were dysphonia (13.6% vs 3.8%) and dysgeusia (3.9% vs 0.5%).
Croatian: Ostali nepovoljni događaji povezani s liječenjem koji su češće spominjani u skupini koja je primala TIP jesu disfonija (13,6 % u odnosu na 3,8 %) te disgeuzija (3,9 % u odnosu na 0,5 %).
English: The most common reasons for discontinuation were adverse events (AEs) - 40 (13.0%) of TIP as compared to 17 (8.1%) TIS-treated patients.
Croatian: Najčešći razlozi za prekid primjene bile su nepovoljni događaji (ND-ovi): 40 (13,0 %) kad je riječ o TIP-u u usporedbi sa 17 (8,1 %) kad je riječ o bolesnicima liječenima TIS-om.
English: • The Committee was of the view that the data support the claim for clinical superiority of Tobramycin VVB versus TOBI Podhaler based on greater safety in a substantial portion of the target population, as per Article 8(3)(c) of Regulation (EC) No 141/2000 read in combination with Article 3(3)(d)(2) of Regulation (EC) No 847/2000;
Croatian: • Odbor je smatrao da podaci potkrepljuju tvrdnju o kliničkoj nadmoći lijeka Tobramycin VVB u odnosu na lijek TOBI Podhaler na temelju veće sigurnosti u znatnom udjelu ciljne populacije, a u skladu s člankom 8. stavkom 3. točkom (c) Uredbe (EZ) br. 141/2000 koji se uzima u obzir zajedno s člankom 3. stavkom 3. točkom (d) podtočkom (2) Uredbe (EZ) br. 847/2000;
English: A higher percentage of TIP- than TIS-treated patients reported AEs (90.3% versus 84.2%, p<0.05).
Croatian: Veći postotak bolesnika liječenih TIP-om naveo je nepovoljne događaje u usporedbi s bolesnicima liječenima TIS-om (90,3 % u odnosu na 84,2 %, p < 0,05).
English: The difference is even more pronounced in the adult cystic fibrosis patient population (14% difference in overall discontinuations and 8% - in discontinuations due to AEs).
Croatian: Razlika je još izraženija u populaciji odraslih pacijenata koji boluju od cistične fibroze (razlika od 14 % u općenitim prekidima primjene lijeka te 8 % u prekidima primjene zbog nepovoljnih događaja).
English: The differences in terms of safety (in terms of tolerability) observed in the EAGER trial between the nebuliser solution and the inhalation powder, favouring the nebuliser solution regarding the occurrence of cough and discontinuation of treatment, are relevant and support the claim of greater safety (in terms of tolerability), as per article Article 8(3)(c) of Regulation (EC) No 141/2000, of Tobramycin VVB in those patients who develop intolerance to TOBI Podhaler.
Croatian: Razlike u pogledu sigurnosti (u odnosu na podnošljivost) primijećene u ispitivanju EAGER između otopine za nebulizator i praška za udisanje, koje prednost daju otopini za nebulizator u odnosu na pojavu kašlja i prekid primjene lijeka, važne su i potkrepljuju tvrdnju o većoj sigurnosti (u smislu podnošljivosti), a u u skladu s člankom 8. stavkom 3. točkom (c) Uredbe (EZ) br. 141/2000, lijeka Tobramycin VVB u bolesnika koji razvijaju netoleranciju na lijek TOBI Podhaler.
English: Fewer adolescents and adults on TIS discontinued study medication as a result of AEs, compared with those on TIP (9.1% on TIS discontinued vs 17.3% on TIP).
Croatian: Manji broj adolescenata i odraslih koji su uzimali TIS prekinuo je uzimanje ispitivanog lijeka zbog nepovoljnih događaja, u usporedbi s bolesnicima koji su uzimali TIP (9,1 % bolesnika koji su uzimali TIS prekinulo je primjenu u odnosu na 17,3 % bolesnika koji su uzimali TIP).
English: Poland considered that the clinical superiority of Tobramycin VVB vs. the orphan-designated medicinal product TOBI Podhaler 28 mg inhalation powder (hereinafter “TOBI Podhaler”) was not demonstrated, therefore derogation as per Article 8(3) of Regulation (EC) No 141/2000 was not fulfilled and a marketing authorisation as proposed by the RMS could not be granted.
Croatian: Poljska je smatrala da nije dokazana klinička nadmoć lijeka Tobramycin VVB u odnosu na odobreni lijek za rijetke bolesti TOBI Podhaler 28 mg, prašak za udisanje (dalje u tekstu: „TOBI Podhaler”), stoga nije ispunjeno odstupanje u skladu s člankom 8. stavkom 3. Uredbe (EZ) br. 141/2000 i nije bilo moguće dati odobrenje za stavljanje u promet kako je predložio RDČ.
English: RMS and CMSs agreed that Tobramycin VVB is comparable to TOBI 300 mg/5 ml nebuliser solution and therefore available efficacy and safety data for TOBI can be extrapolated to Tobramycin VVB.
Croatian: RDČ i PDČ-ovi dogovorili su se da je lijek Tobramycin VVB usporediv s lijekom TOBI 300 mg/5 ml, otopinom za nebulizator te da je stoga dostupnu učinkovitost i podatke o sigurnosti lijeka TOBI moguće ekstrapolirati na lijek Tobramycin VVB.
English: To substantiate the relevance of difference in the incidence of adverse events (e.g. cough, discontinuation, etc.) between Tobramycin VVB and the orphan-designated medicinal product TOBI Podhaler based on own and/or published data.
Croatian: potkrjepljivanje važnosti razlike u pojavi nepovoljnih događaja (npr. kašlja, prekida primjene lijeka itd.) između lijekova Tobramycin VVB i odobrenog lijeka TOBI
English: UAB “VVB” submitted on 2 May 2014 a marketing authorisation application for Tobramycin VVB 300 mg/5 ml nebuliser solution (hereinafter “Tobramycin VVB”) as an abridged application in accordance with Article 10(3) of Directive 2001/83/EC, referring to Nebcin solution for injection (PL 13621/0059) for the purpose of the data exclusivity, and to TOBI 300 mg/5 ml nebuliser solution (hereinafter “TOBI”; PL 00101/0935) for the purpose of the SmPC/clinical comparator.
Croatian: Tvrtka UAB „VVB” podnijela je 2. svibnja 2014. zahtjev za davanje odobrenja za stavljanje u promet lijeka Tobramycin VVB 300 mg/5 ml, otopine za nebulizator (u nastavku „Tobramycin VVB”) kao skraćeni zahtjev u skladu s člankom 10. stavkom 3. Direktive 2001/83/EZ, a u kojem se upućuje na otopinu za ubrizgavanje Nebcin (PL 13621/0059) radi zaštite podataka o lijeku te na otopinu za nebulizator TOBI 300 mg/5 ml (dalje u tekstu: „TOBI”; PL 00101/0935) u svrhu usporedbe sažetka opisa svojstava lijeka / kliničkih elemenata.
English: The proposed therapeutic indication for Tobramycin VVB 300 mg/5 ml nebuliser solution is the same as for TOBI Podhaler (EU/1/10/652, Tobramycin, inhalation powder) and identical to that of TOBI 300 mg/5ml nebuliser solution: “suppressive therapy of chronic pulmonary infection due to Pseudomonas aeruginosa in adults and children aged 6 years and older with cystic fibrosis.”
Croatian: Predložena terapijska indikacija lijeka Tobramycin VVB 300 mg/5 ml, otopine za nebulizator ista je kao indikacija lijeka TOBI Podhaler (EU/1/10/652, Tobramycin, prašak za udisanje) te istovjetna indikaciji lijeka TOBI 300 mg/5ml otopini za nebulizator: „supresivna terapija kronične upale pluća prouzročene bakterijom Pseudomonas aeruginosa u odraslih i djece u dobi od šest i više godina koji boluju od cistične fibroze.”
English: Cough events were suspected by the investigator as being related to study drug in 25.3% and 4.3% of patients in the TIP and TIS group, respectively.
Croatian: Istražitelj je posumnjao da je kašalj povezan s ispitivanim lijekom u 25,3 % bolesnika u skupini koja je primala TIP, odnosno te 4,3 % u skupini koja je primala TIS.
English: In the EAGER study, cough described as an adverse drug related event was observed in 25% of patients on the inhalation powder vs. 4% of patients on the nebuliser solution.
Croatian: U ispitivanju EAGER kašalj kao nepovoljan događaj povezan s lijekom primijećen je u 25 % bolesnika kad je riječ o uzimanju praška za udisanje u odnosu na 4 % bolesnika koji su uzimali otopinu za nebulizator.
English: The applicant of Tobramycin VVB has applied for a derogation from the market exclusivity of TOBI Podhaler 28 mg inhalation powder claiming that Tobramycin VVB 300 mg/5 ml nebuliser solution is clinically superior to the authorised orphan medicinal product (TOBI Podhaler 28 mg inhalation powder) in terms of providing greater safety in a substantial portion of the target population.
Croatian: Podnositelj zahtjeva za lijek Tobramycin VVB podnio je zahtjev za odstupanjem od tržišne ekskluzivnosti lijeka TOBI Podhaler 28 mg, praška za udisanje tvrdeći da je Tobramycin VVB 300 mg/5 ml otopina za nebulizator klinički nadmoćan u odnosu na odobreni lijek za rijetke bolesti (TOBI Podhaler prašak za udisanje od 28 mg) u smislu pružanja veće sigurnosti velikom udjelu ciljne populacije.
English: The medicinal product TOBI Podhaler 28 mg inhalation powder is covered by an orphan designation in the condition treatment of P. aeruginosa lung infection in cystic fibrosis (orphan designation EU/3/03/140).
Croatian: Lijek TOBI Podhaler 28 mg, prašak za udisanje obuhvaćen je odobrenjem lijeka za rijetke bolesti u liječenju upale pluća P. aeruginosa u slučaju cistične fibroze (odobrenje lijeka za rijetke bolesti EU/3/03/140).
English: Therefore the CHMP concluded that the clinical relevance of the abovementioned differences between Tobramycin VVB and TOBI Podhaler demonstrates the clinical superiority of Tobramycin VVB over TOBI Podhaler based on greater safety in a substantial portion of the target population.
Croatian: Stoga je CHMP zaključio da klinička važnost spomenutih razlika između lijekova Tobramycin VVB i TOBI Podhaler dokazuje kliničku nadmoć lijeka Tobramycin VVB u odnosu na TOBI
English: On day 210, major issues on safety and efficacy were raised which remained unsolved; hence the procedure was referred to the CMDh, under Article 29, paragraph 1 of Directive 2001/83/EC by Lithuania on 24 July 2015.
Croatian: Dana 210. izražena su velika pitanja u odnosu na sigurnost i učinkovitost, koja su ostala neriješena, stoga je 24. srpnja 2015.
English: In the light of the above, to further justify why the applicant considers Tobramycin VVB clinically superior in a substantial portion of the target population to the orphan-designated medicinal product TOBI Podhaler.
Croatian: U svjetlu prethodno navedenoga, a kako bi se obrazložilo zašto podnositelj zahtjeva lijek Tobramycin VVB smatra klinički nadmoćnim u velikom udjelu ciljne populacije u odnosu na odobreni lijek za rijetke bolesti TOBI Podhaler.
English: The importance of cough as AE for a powder formulation was already acknowledged during the assessment of TOBI Podhaler, and it is recommended that alternative treatment with the nebuliser solution is considered for patients using TOBI Podhaler who experience continued therapy-induced cough.
Croatian: Podhaler te se preporučuje da se u obzir uzme alternativno liječenje otopinom za nebulizator za bolesnike koji uzimaju lijek TOBI Podhaler, a koji imaju stalan kašalj prouzročen terapijom.
English: The post hoc subgroup analysis of EAGER trial data confirmed the
Croatian: Analizom post hoc podataka podskupine iz ispitivanja EAGER potvrđene su razlike u stopama pojave kašlja u svim dobnim skupinama.
English: 3 inhalers with 60 actuations
Croatian: 3 inhalatora sa po 60 doza
English: Invented name
Croatian: Zaštićeno ime Doza
English: This summary was last updated in September 2013.
Croatian: Sažetak je posljednji put dopunjen u rujnu 2013.
English: It is available as chewable tablets in five strengths (90 mg, 140 mg, 180 mg, 270 mg, 425 mg) for dogs and cats and in three additional strengths for larger dogs (665 mg, 1040 mg and 1620 mg).
Croatian: Dostupan je u obliku tableta za žvakanje u pet jačina (90 mg, 140 mg, 180 mg, 270 mg, 425 mg) za pse i mačke, te tri dodatne jačine za veće pse (665 mg, 1040 mg i 1620 mg).
English: Comfortis is given as a single dose which can be repeated every month.
Croatian: Comfortis se primjenjuje kao jedna doza koja se mora ponoviti svaki mjesec.
English: Comfortis is a veterinary medicine that contains spinosad.
Croatian: Comfortis je veterinarsko-medicinski proizvod koji sadrži spinosad.
English: Similarly Comfortis tablets should be given with a meal or immediately after feeding in cats.
Croatian: Podjednako tako, tablete Comfortis trebaju se davati uz obrok ili neposredno nakon obroka u mačaka.
English: Other information about Comfortis:
Croatian: Druge informacije o VMP-u Comfortis:
English: The studies also showed that the preventive effect of spinosad against new flea infestations (which results from its residual insecticidal activity) lasts for up to 4 weeks.
Croatian: Ispitivanja također dokazuju da preventivno djelovanje spinosada protiv novih infestacija buhama (što je rezultatom njegovog rezidualnog insekticidnog djelovanja) traje do 4 tjedna.
English: If you want more information on the basis of the CVMP recommendations, read the Scientific Discussion (also part of the EPAR).
Croatian: Ako želite više informacija na temelju preporuka Odbora za veterinarsko-medicinske proizvode (CVMP), pročitajte znanstvenu raspravu (ista je dio Europskoga javnog izvješća o procjeni veterinarsko-medicinskog proizvoda (EPAR)).
English: The effectiveness of the product was measured by looking at the number of fleas that were alive at various times after treatment.
Croatian: Djelotvornost proizvoda izmjerena je evidentiranjem broja buha koje su bile žive u različita vremena nakon liječenja.
English: Use of Comfortis tablets in dogs or cats which have epilepsy may involve additional risks.
Croatian: Primjena tableta Comfortis u pasa ili mačaka koji pate od epilepsije može uključivati dodatne rizike.
English: Other common side effects in cats include diarrhoea and loss of appetite.
Croatian: Ostale učestale nuspojave u mačaka uključuju proljev i gubitak apetita.
English: The appropriate strength tablet(s) should be used according to the dog's or cat's weight (the dose differs between dogs and cats).
Croatian: Odgovarajuća jačina tablete(a) treba se koristiti u skladu s tjelesnom težinom psa ili mačke (doza za pse i mačke se razlikuje).
English: Comfortis has been studied in laboratory animals, as well as in dogs or cats that were treated in various veterinary practices and clinics across Europe (“clinical studies”).
Croatian: Comfortis se ispitivao u laboratorijskih životinja, kao i u pasa i mačaka koji su liječeni u različitim veterinarskim ambulantama i klinikama diljem Europe („klinička ispitivanja”).
English: The active substance in Comfortis, spinosad, is an insecticide which works by interfering with certain receptors (nicotinic acetylcholine receptors) in the fleas' nervous system, which results in their subsequent paralysis and death.
Croatian: Djelatna tvar u VMP-u Comfortis, spinosad, insekticid je koji interferira s određenim receptorima (receptore nikotin acetilholina) u živčanom sustavu buha, što rezultira njihovom naknadnom paralizom i smrću.
English: Comfortis tablets are not recommended for use in dogs weighing less than 1.3 kg or in cats weighing less than 1.2 kg (as accurate dosing of the product in such small dogs or cats is not possible and they may be accidentally overdosed).
Croatian: Tablete Comfortis ne preporučaju se za uporabu u pasa tjelesne težine manje od 1.3 kg ili u mačaka tjelesne težine manje od 1.2 kg (precizno doziranje u tako malih pasa ili mačaka nije moguće te se tako male životinje mogu slučajno predozirati).
English: The studies involved dogs and cats of different age groups, genders, breeds and weights.
Croatian: Ispitivanja su uključivala pse i mačke različitih dobnih skupina, spolova, pasmina i tjelesnih težina.
English: Studies also showed that the frequency and severity of flea allergy dermatitis (an allergic reaction to flea bites) is significantly decreased in dogs and cats treated with Comfortis and so its use as part of a treatment strategy for the control of this condition is justified.
Croatian: Ispitivanja su također pokazala da je učestalost i težina alergijskog dermatitisa na ugriz buha (alergijske reakcije na ugrize buha) značajno smanjena u pasa i mačaka liječenih VMP-om Comfortis te je stoga njegova uporaba kao dijela strategije liječenja za kontrolu ovoga stanja opravdana.
English: The most common side effect is vomiting, which is mild and transient in most dogs and cats.
Croatian: Najčešća nuspojava je povraćanje, koje je blago i prolazno u većine pasa i mačaka.
English: This document is a summary of the European Public Assessment Report (EPAR).
Croatian: Sažetak Europskoga javnog izvješća o procjeni (EPAR)
English: Comfortis tablets must not be used in dogs or cats aged less than 14 weeks, or in dogs or cats that are hypersensitive (allergic) to spinosad or any of the other ingredients in the tablets.
Croatian: Tablete Comfortis ne smiju se koristiti u pasa i mačaka mlađih od 14 tjedana, ili u pasa i mačaka koji su preosjetljivi (alergični) na spinosad ili bilo koju drugu pomoćnu tvar u tabletama.
English: The CVMP concluded that the benefits of Comfortis outweigh the risks when used for the approved indications and recommended that Comfortis be given a marketing authorisation.
Croatian: CVMP je zaključio da koristi od VMP-a Comfortis nadmašuju s njim povezane rizike za odobrene indikacije, te je preporučio izdavanje odobrenja za stavljanje u promet VMP-a Comfortis.
English: What is the risk associated with Comfortis?
Croatian: Koji su rizici povezani s VMP-om Comfortis?
English: People who give the medicine should wash their hands after handling Comfortis.
Croatian: Osobe koje primjenjuju VMP moraju oprati ruke nakon primjene VMP-a Comfortis.
English: Accidental ingestion, including by children, may cause adverse reactions.
Croatian: U slučaju da se nehotice proguta, uključujući i od strane djece, može izazvati nuspojave.
English: The results of laboratory studies demonstrated that the product was effective at killing the fleas on dogs or cats with existing flea infestations within 24 hours after treatment.
Croatian: Rezultati laboratorijskih ispitivanja pokazali su da je proizvod bio djelotvoran u ubijanju u pasa ili mačaka s postojećom infestacijom buhama unutar 24 sata nakon liječenja.
English: Why has Comfortis been approved?
Croatian: Zašto je Comfortis odobren?
English: Comfortis can also be used as part of a treatment strategy for flea allergic dermatitis (an allergic reaction to flea bites).
Croatian: Comfortis se može upotrijebiti kao dio strategije liječenja alergijskog demartitisa na ugriz buhe (alergijske reakcije na ugrize buha).
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Comfortis on 11/02/2011.
Croatian: Europska komisija izdala je 11.02.2011. odobrenje za stavljanje u promet VMP-a Comfortis koje vrijedi na prostoru Europske unije.
English: In the clinical studies, Comfortis was compared with a veterinary medicine authorised in the EU for the treatment and prevention of flea infestations (selamectin, a ‘spot-on' applied to the skin of the dog or cat).
Croatian: U kliničkim ispitivanjima, Comfortis je uspoređen s veterinarsko-medicinskim proizvodom odobrenim u EU za liječenje i prevenciju infestacije buhama (selamektin, otopina za nakapavanje na kožu pasa ili mačaka).
English: The medicine starts killing fleas on the dog or cat 30 minutes after giving the tablet(s) and it remains active for up to four weeks.
Croatian: VMP počinje ubijati buhe 30 minuta nakon primjene tablete(a) kod pasa ili mačaka, te ostaje aktivan do četiri tjedna nakon primjene.
English: What is Comfortis?
Croatian: Što je Comfortis?
English: Comfortis is used to treat and prevent flea infestations in dogs and cats.
Croatian: Comfortis se koristi za liječenje i sprječavanje infestacija buhama u pasa i mačaka.
English: The clinical studies, carried out for between one and three months, showed that Comfortis is as effective as the comparator medicine in the treatment of flea infestations in dogs and cats.
Croatian: Klinička ispitivanja u trajanju od jednog do tri mjeseca ukazuju da je Comfortis podjednako djelotvoran kao komparativan VMP u liječenju infestacija buhama u psa i mačaka.
English: The safety of Comfortis has not been sufficiently established in dogs or cats that are pregnant or breeding (male or female).
Croatian: Sigurnost VMP-a Comfortis nije u potpunosti utvrđena u pasa ili mačaka koji su gravidni ili rasplodni (mužjaka ili ženki).
English: In case of accidental ingestion, medical advice should be sought immediately and the package leaflet or the label shown to the doctor.
Croatian: U slučaju da se nehotice proguta odmah potražiti pomoć liječnika i pokažite mu uputu o VMP ili etiketu.
English: Comparative studies on fed/fasted dogs indicated that Comfortis tablets should be given with a meal to increase the amount of the active substance absorbed by the dog.
Croatian: Usporedna ispitivanja na psima koji su nahranjeni/postili ukazuju da se tablete Comfortis trebaju davati uz obrok kako bi se povećala količina djelatne tvari koju pas apsorbira.
English: Laboratory studies were carried out to look at the effectiveness of Comfortis in killing the fleas on dogs and cats with existing flea infestations, and at the speed of killing fleas on the treated animals.
Croatian: Laboratorijska ispitivanja provedena su kako bi se ispitala djelotvornost VMP-a Comfortis u ubijanju buha u pasa i mačaka s postojećim infestacijama buha, te brzina ubijanja buha u liječenih životinja.
English: What benefit has Comfortis shown during the studies?
Croatian: Koje koristi VMP-a Comfortis su utvrđene tijekom ispitivanja?
English: What is Comfortis used for?
Croatian: Za što se Comfortis koristi?