natgillin/translations-raw huggingface dataset:
The information that was introduced in the SmPC of tolperisone was based on two well-designed studies conducted with different formulations of tablets, which showed that compared to the fasting state, fat-rich food increases the bioavailability of tolperisone by about
Informacije koje su uvrštene u SmPC za tolperizon temeljile su se na dva dobro razrađena ispitivanja provedena s različitim formulacijama tableta, koja su pokazala da hrana bogata mastima u odnosu na uvjete natašte povećava bioraspoloživost tolperizona za oko 100 %.
Although the results of the bioequivalence studies were considered to be borderline by the objecting CMS, the applicant argued that the second bioequivalence study was a replicate design study where it was shown that tolperisone is a highly variable drug - the within-subject variability of the reference medicinal product Cmax was 46.99%.
Iako je CMS koji je uložio prigovor smatrao da su rezultati ispitivanja bioekvivalencije granični, podnositelj zahtjeva tvrdio je da je drugo ispitivanje bioekvivalencije predstavljalo ponovljeno ispitivanje u kojem je dokazano da je tolperizon vrlo varijabilan lijek - Cmax intraindividualne varijabilnosti referentnog lijeka iznosio je 46,99 %.
As there is no evidence that the food-effect is formulation dependent, the majority of the CHMP concluded that the bioequivalence studies conducted in the fasting state, which is considered to be the most sensitive condition, would give sufficient evidence to conclude on the bioequivalence in both the fasting and fed states in this particular case.
Budući da nema dokaza da učinak hrane ovisi o formulaciji, većina članova CHMP-a zaključila je da ispitivanja bioekvivalencije provedena u uvjetima natašte, koji se smatraju najosjetljivijim uvjetima, pružaju dovoljno dokaza za donošenje zaključka o bioekvivalenciji u stanju sitosti i natašte u ovom konkretnom slučaju.
Taking into account that the MAH had submitted data which showed that tolperisone is a highly soluble and highly permeable active substance, neither solubility nor dissolution was considered to be a limiting factor in terms of in vivo absorption.
Uzimajući u obzir da je nositelj odobrenja za stavljanje lijeka u promet dostavio podatke koji pokazuju da je tolperizon vrlo topiva i vrlo propusna djelatna tvar, smatra se da ni topivost ni rastvorivost nisu ograničavajući čimbenici u pogledu in vivo apsorpcije.
Taking into account all the evidence and arguments presented, the majority of the CHMP noted that that bioequivalence had been demonstrated in the fasting state for tolperisone, which is highly soluble and highly permeable active substance, demonstrating high within-subject variability.
Uzimajući u obzir sve iznesene dokaze i argumente, većina članova CHMP-a smatrala je da je u uvjetima natašte dokazana bioekvivalencija za tolperizon, koji je vrlo topiva i vrlo propusna djelatna tvar s vrlo visokom intraindividualnom varijabilnošću.
In the study with the 50 mg tablet, bioequivalence was not demonstrated as the upper limit of the Cmax was outside the upper band, i.e.
U ispitivanju tableta od 50 mg bioekvivalencija nije dokazana budući da je najviša vrijednost Cmax bila izvan gornjeg ograničenja, odnosno 125,49 %.
Therefore the objecting member state was of the view that the two bioequivalence submitted with the 50 and 150mg tolperisone tablets under fasting conditions were not sufficient, and that bioequivalence should be demonstrated under fed conditions.
Stoga je država članica koja je uložila prigovor smatrala da dva ispitivanja bioekvivalencije podnesena za tablete s 50 i 150 mg tolperizona u uvjetima natašte nisu dostatna te da bioekvivalenciju treba dokazati u uvjetima uz hranu.
• The Committee was of the view that results of the submitted bioequivalence studies showed that Merisone 50 and 150 mg tablets was bioequivalent to the reference medicinal product Mydeton 50 and 150-mg tablets under fasting conditions;
• Povjerenstvo smatra da su rezultati dostavljenih ispitivanja bioekvivalencije pokazali da su tablete Merisone od 50 i 150 mg bioekvivalenti referentnog lijeka Mydeton u obliku tableta od 50 i 150 mg u uvjetima natašte;
Therefore based on the results of the submitted bioequivalence studies, the CHMP members agreed that Merisone 50 and 150 mg tablets are bioequivalent to the reference medicinal product Mydeton 50 and 150-mg tablets (Gedeon Richter Plc) under fasting conditions.
Stoga su na temelju dostavljenih rezultata ispitivanja bioekvivalencije članovi CHMP-a bili suglasni da su tablete Merisone od 50 i 150 mg bioekvivalenti referentnog lijeka Mydeton u tabletama od 50 i 150 mg (Gedeon Richter Plc) u uvjetima natašte.
However more recently the effect of food on the bioavailability of tolperisone has been established to be significant and was reflected accordingly in the SmPC of the reference medicinal product at the time of submission of the MAA subject to this referral1.
Međutim, nedavno je utvrđeno da je učinak hrane na bioraspoloživost tolperizona značajan, što je u trenutku podnošenja zahtjeva za stavljanje u promet koji podliježe ovom postupku upućivanja1 bilo na odgovarajući način naznačeno u sažetku opisa svojstava referentnog lijeka.
The CHMP also noted that the excipients mannitol and betaine found in the product subject to the referral but not in the reference medicinal product, had no effect on the bioequivalence of these products in fasting state.
CHMP je također naveo da pomoćne tvari manitol i betain, koje se nalaze u lijeku koji je predmet postupka upućivanja, ali ne i u referentnom lijeku, nisu imale učinak na bioekvivalenciju lijekova u uvjetima natašte.
The CHMP noted that the excipients mannitol and betaine found in the product subject to the referral but not in the reference medicinal product, had no effect on the bioequivalence of these products in fasting state.
CHMP je naveo da pomoćne tvari manitol i betain, koje se nalaze u lijeku koji je predmet postupka upućivanja, ali ne i u referentnom lijeku, nisu imale učinak na bioekvivalenciju lijekova u uvjetima natašte.
Other PKWP members were of the view that a fed study would not have been required only if the effects of food were known to be solely hepatic, which however was considered to be insufficiently supported, and since the food effect for tolperisone was considered to be significantly high, a study in a fed state should have been performed.
Ostali članovi PKWP-a smatrali su da ispitivanje u uvjetima uz hranu ne bi bilo potrebno samo u slučaju da su učinci hrane isključivo hepatički, no smatrali su da za to ne postoje dostatni dokazi.
Bioequivalence was demonstrated with regard to the primary pharmacokinetic parameters, i.e. AUC and Cmax, in the study with the 150 mg tablet, as the 90% CIs were within the required 80-125% limits.
PIK i Cmax, u ispitivanju tableta od 150 mg budući da su intervali pouzdanosti od 90 % bili u prihvatljivom rasponu od 80 - 125 %.
It is available as capsules (12.5 mg, 25 mg, 37.5 mg and 50 mg).
Dostupan je kao kapsule (12,5 mg, 25 mg, 37,5 mg i 50 mg).
The full EPAR for Sutent can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Cjeloviti EPAR za lijek Sutent nalaze se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
The main measure of effectiveness in all of the studies was how long the patients lived without their tumours getting worse.
Glavna mjera djelotvornosti u svim ovim ispitivanjima bilo je koliko su dugo bolesnici živjeli bez pogoršanja tumora.
This was switched to a full marketing authorisation on 11 January 2007.
Ovo je odobrenje promijenjeno u potpuno odobrenje za stavljanje u promet dana 11. siječnja 2007.
As the company has supplied the additional information necessary, the authorisation has been switched from conditional to full approval.
Budući da je tvrtka dostavila dostane potrebne informacije, odobrenje je promijenjeno iz uvjetovanog u potpuno odobrenje.
Sutent is used to treat adults with the following types of cancer:
Sutent se koristi za liječenje odraslih osoba sa sljedećim tipovima raka:
Other information about Sutent
Ostale informacije o lijeku Sutent
This means that it blocks some specific enzymes known as protein kinases.
To znači da inhibira određene enzime poznate pod nazivom protein kinaze.
The European Commission granted a conditional marketing authorisation valid throughout the European Union for Sutent on 19 July 2006.
Europska komisija izdala je uvjetno odobrenje za stavljanje u promet koje za lijek Sutent vrijedi na prostoru Europske unije od 19. srpnja 2006.
What measures are being taken to ensure the safe and effective use of Sutent?
Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Sutent?
This is a summary of the European public assessment report (EPAR) for Sutent.
Ovo je sažetak Europskoga javnog izvješća o ocjeni dokumentacije (EPAR) za lijek Sutent.
A risk management plan has been developed to ensure that Sutent is used as safely as possible.
Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Sutent.
Sutent is used in patients with GISTs that cannot be removed with surgery or have spread to other parts of the body.
Sutent se koristi u bolesnika s GIST-ovima koji se ne mogu ukloniti kirurškim zahvatom ili su se proširili u druge dijelove tijela.
The most common side effects with Sutent (seen in more than 1 in 10 patients) include fatigue (tiredness), gastrointestinal disorders (such as diarrhoea, feeling sick, inflammation of the lining of the mouth, indigestion and vomiting), respiratory (such as shortness of breath and cough) and skin disorders (such as skin discoloration, dryness of the skin and rash), hair color changes, dysgeusia (taste disturbances), epistaxis (nosebleeds), loss of appetite, hypertension (high blood pressure), palmar-plantar erythrodysaesthesia syndrome (rash and numbness on the palms and soles), hypothyroidism (an underactive thyroid gland), insomnia (difficulty falling and staying asleep), dizziness, headache, arthralgia (joint pain), neutropenia (low levels of neutrophils, a type of white blood cell), thrombocytopenia (low blood platelet counts), anaemia (low red blood cell counts), and leucopenia (low white blood cell counts).
Najčešće nuspojave lijeka Sutent (mogu se javiti u više od 1 na 10 osoba) su iscrpljenost (umor), gastrointestinalni poremećaji (poput proljeva, osjećaja slabosti, upale sluznice usta, indigestije i povraćanja), respiratorni (poput zadihanosti i kašlja) i kožni poremećaji (poput promjene u boji kože, suhoće kože i osipa), promjene u boji kose, disgeusije (poremećaja u okusu), epistakse (krvarenja iz nosa), gubitak apetita, hipertenzije (visokog krvnog tlaka), sindrom palmarno-plantarne eritrodizestezije (osipa i utrnuća dlanova i stopala), hipotiroidizam (premala aktivnost štitnjače), insomija (poteškoće u spavanju), vrtoglavica, glavobolja, artralgija (bol u zglobovima), neutropenija
Sutent is used if the disease is getting worse and the tumour cells are well-differentiated (similar to normal cells in the pancreas).
Sutent se koristi ako se bolest pogoršala te ako su stanice tumora dobro diferencirane (slične normalnim stanicama u gušterači).
What is the risk associated with Sutent?
Koji su rizici povezani s lijekom Sutent?
For more information about treatment with Sutent, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Više informacija o terapiji lijekom Sutent pročitajte u uputi o lijeku (također dio EPAR-a), ili se obratite svom liječniku ili ljekarniku.
The active substance in Sutent, sunitinib, is a protein kinase inhibitor.
Djelatna tvar lijeka Sutent, sunitinib, je inhibitor protein kinaze.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Sutent.
Pojašnjava kako je Odbor za lijekove za humanu uporabu (CHMP) ocijenio lijek da bi donio mišljenje u korist izdavanja odobrenja za stavljanje lijeka u promet i svoje preporuke o uvjetima primjene lijeka Sutent.
It is used after treatment with imatinib (another cancer medicine) has failed;
Koristi se nakon neuspješnog liječenja imatinibom (drugog antineoplastičnog lijeka);
Sutent was more effective than placebo in treating GIST and pancreatic neuroendocrine tumours.
Sutent je bio djelotvorniji od placeba u liječenju GIST-a i neuroendokrinih tumora gušterače.
• gastrointestinal stromal tumour (GIST), a type of cancer of the stomach and bowel where there is uncontrolled growth of cells in the supporting tissues of these organs.
• gastrointestinalnog stromalnog tumora (GIST), tipa raka želuca i crijeva kada postoji nekontrolirani rast stanica u potpornim tkivima ovih organa.
The CHMP decided that Sutent's benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je odlučio da koristi da koristi od lijeka Sutent nadmašuju s njim povezane rizike te je preporučilo izdavanje odobrenja za stavljanje lijeka u promet.
By blocking these enzymes, Sutent can reduce the growth and spread of the cancer and cut off the blood supply that keeps cancer cells growing.
Inhibirajući ove enzime, lijek Sutent može smanjiti rast i širenje raka te prekinuti dovod krvi koji održava rast stanica raka.
Sutent was originally given ‘conditional approval' because there was more evidence to come about the medicine, in particular in the treatment of renal cell carcinoma.
Za lijek Sutent izdano je „uvjetno odobrenje” budući da je trebalo dostaviti dodatne dokaze o lijeku, posebice za liječenje tumora bubrežnih stanica.
Why has Sutent been approved?
Zašto je Sutent odobren?
Sutent is a medicine that contains the active substance sunitinib.
Sutent je lijek koji sadrži djelatnu tvar sunitinib.
• pancreatic neuroendocrine tumours (tumours of the hormone-producing cells in the pancreas) that have spread or cannot be removed with surgery.
• neuroendokrinih tumora gušterače (tumori stanica koji proizvode hormone u štitnjači) koji su se proširili ili se ne mogu ukloniti kirurškim zahvatom.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Sutent, including the appropriate precautions to be followed by healthcare professionals and patients.
Na temelju tog plana u sažetak opisa svojstava lijeka kao i u uputu o lijeku, za lijek Sutent uključene su sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju primjenjivati.
Sutent was also compared with another cancer medicine, interferon alfa, in 750 patients with metastatic renal cell carcinoma whose cancer had not been treated before.
Sutent je također uspoređen s drugim antineoplastičnim lijekom, interferonom alfa, u 750 bolesnika s metastatskim karcinom bubrežnih stanica čiji rak nije prethodno liječen.
The most serious side effects reported with Sutent include heart and kidney failure, pulmonary embolism (clot in a blood vessel supplying the lungs), gastrointestinal perforation (holes in the wall of the gut), and internal haemorrhages (bleeding).
Najozbiljnije nuspojave prijavljene s lijekom Sutent uključuju zatajenje srca i bubrega, pulmonalnu emboliju (ugrušak u krvnoj žili koja opskrbljuje pluća), gastrointestinalnu perforaciju (rupe u stjenci crijeva) i unutarnje hermoragije (krvarenja).
Sutent was compared with placebo (a dummy treatment) in 312 patients with GIST whose previous treatment with imatinib had failed and in 171 patients with worsening pancreatic neuroendocrine tumours that could not be removed with surgery.
Sutent je uspoređen s placebom (lažnim liječenjem) u 312 bolesnika oboljelih od GIST-a čije je prethodno liječenje lijekom imatinib bilo neuspješno i u 171 bolesnika s pogoršanjem neuroendokrinih tumora gušterače koji se ne mogu ukloniti kirurškim zahvatom.
• metastatic renal cell carcinoma, a type of kidney cancer, that has spread to other parts of the body;
• metastatskog karcinoma bubrežnih stanica, tipa raka bubrega, koji se proširio u druge dijelove tijela;
Patients with GIST taking Sutent lived for an average of 26.6 weeks without the disease getting worse, compared with 6.4 weeks in the patients taking placebo.
Bolesnici s GIST-om koji su uzimali Sutent živjeli su prosječno 26,6 tjedana bez pogoršanja bolesti u usporedbi sa 6,4 tjedana u bolesnika koji su uzimali placebo.
These enzymes can be found in some receptors at the surface of cancer cells, where they are involved in the growth and spread of cancer cells and in the blood vessels that supply the tumours, where they are involved in the development of new blood vessels.
Ovi se enzimi nalaze u određenim receptorima na površini stanica raka, uključujući i receptore koji su uključeni u rast i širenje stanica raka i krvnih žila koje opskrbljuju tumore koji su uključeni u razvoj novih krvnih stanica.
For GIST and metastatic renal cell carcinoma, Sutent is given in six-week cycles, at a dose of 50 mg once a day for four weeks, followed by a two-week ‘rest period'.
Za liječenje GIST-a i metastatskog karcinoma bubrežnih stanica Sutent se primjenjuje u šestotjednim ciklusima u dozi od 50 mg jedanput na dan tijekom 4 uzastopna tjedna, nakon čega slijedi dvotjedni period odmora.
In metastatic renal cell carcinoma, patients taking Sutent lived for an average of 47.3 weeks without their disease worsening, compared with 22.0 weeks in the patients receiving interferon alfa.
U slučaju metastatskog karcinoma bubrežnih stanica, bolesnici koji su uzimali Sutent živjeli su prosječno 47,3 bez pogoršanja bolesti u usporedbi 22,0 tjedna u bolesnika koji su uzimali interferon alfa.
What is Sutent used for?
Za što se Sutent koristi?
Treatment with Sutent should be started by doctors who have experience in administering cancer medicines.
Liječenje lijekom Sutent mora započeti liječnik s iskustvom u primjeni antineoplastičnih lijekova.
What benefit has Sutent shown during the studies?
Koje su koristi lijeka Sutent utvrđene u ispitivanjima?
For pancreatic neuroendocrine tumours the figures were 11.4 months in the Sutent group and 5.5 months in the placebo group.
U slučaju neuroendokrinih tumora gušterače, bolesnici u grupi koja je uzimala Sutent živjeli su prosječno 11,4 mjeseca, a bolesnici u grupi koja je uzimala placebo živjeli su prosječno 5,5 mjeseci.
The dose can be adjusted according to the patient's response to the treatment, but should be kept within the range of 25 to 75 mg. For pancreatic neuroendocrine tumours, Sutent is given at a dose of 37.5 mg once a day without a rest period.
Doza se može prilagoditi ovisno o odgovoru bolesnika na liječenje, no mora se zadržati u rasponu od 25 do 75 mg.
How is Sutent used?
Kako se Sutent koristi?
How has Sutent been studied?
Kako je Sutent ispitivan?
For the full list of all side effects and restrictions with Sutent, see the package leaflet.
Potpuni popis nuspojava zabilježenih pri primjeni lijeka Sutent potražite u uputi o lijeku.
MA (EU) number (Invented) name
Broj (EU) oborenja
Intravenous use
Put primjene Unutarnje pakovanje
The full EPAR for Mysildecard can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Cjeloviti EPAR za lijek Mysildecard nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The active substance in Mysildecard, sildenafil, belongs to a group of medicines called ‘phosphodiesterase-type-5 (PDE5) inhibitors', which means that it blocks the PDE5 enzyme.
Djelatna tvar lijeka Mysildecard, sildenafil, ubraja se u skupinu lijekova naziva „inhibitori fosfodijesteraze tipa 5 (PDE5)”, što znači da blokira enzim PFE5.
In this case Mysildecard was not compared with the reference product Revatio, but with Viagra.
U ovom slučaju lijek Mysildecard nije uspoređen s referentim proizvodom Revatio, nego s lijekom Viagra.
This is a summary of the European public assessment report (EPAR) for Mysildecard.
Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) za lijek Mysildecard.
For lower doses, other medicines containing sildenafil should therefore be used.
Stoga se kod nižih doza trebaju koristiti ostali lijekovi koji sadrže sildenafil.
Mysildecard is available as tablets (20 mg).
Mysildecard je dostupan u obliku tableta (20 mg).
Because Mysildecard is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Budući da je Mysildecard generički lijek, smatra se da su njegove koristi i rizici isti kao i oni referentnog lijeka.
Mysildecard is a medicine used to treat adults and children from 1 year of age with pulmonary arterial hypertension (PAH, abnormally high blood pressure in the arteries of the lungs).
Mysildecard je lijek koji se primjenjuje u liječenju odraslih osoba i djece u dobi od jedne godine i starije s plućnom arterijskom hipertenzijom (PAH, abnormalno visok krvni tlak u plućnim arterijama).
This means that Mysildecard is similar to a ‘reference medicine' already authorised in the European Union (EU) called Revatio.
To znači da je lijek Mysildecard sličan „referentnom lijeku” koji je već odobren u Europskoj uniji pod nazivom Revatio.
Because the effectiveness and safety of sildenafil in PAH is already well established, studies in people have been limited to tests to determine that it is bioequivalent to another authorised sildenafilcontaining tablet.
Budući da je djelotvornost i sigurnost sildenafila u liječenju PAH-a već utvrđena, istraživanja na ljudima bila su ograničena na ispitivanja kojima se željela dokazati njegova bioekvivalentnost s drugom odobrenom tabletom koja sadrži sildenafil.
It is not intended to provide practical advice on how to use Mysildecard.
Svrha sažetka nije davati praktične savjete o korištenju lijeka Mysildecard.
Mysildecard can only be obtained with a prescription and treatment should be started and monitored by a doctor who has experience in the treatment of PAH.
Lijek Mysildecard izdaje se samo na liječnički recept, a liječenje smije započeti i nadzirati samo liječnik s iskustvom u liječenju PAH-a.
What measures are being taken to ensure the safe and effective use of Mysildecard?
Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Mysildecard?
This was considered acceptable since Revatio and Viagra have the same qualitative composition and are made in the same way by the same manufacturer.
To se smatralo primjerenim zbog jednakog kvalitativnog sastava lijeka Revatio i Viagra te činjenice da ih isti proizvođač proizvodi na jednak način.
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Mysildecard was considered to be comparable to Revatio.
Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji odlučio je kako je u skladu sa zahtjevima EU-a dokazano da je lijek Mysildecard usporediv s lijekom Revatio.
Lower doses of Mysildecard may be needed in patients taking some medicines that affect the way Mysildecard is broken down in the body.
Niže doze lijeka mogu se propisati za liječenje bolesnika koji uzimaju pojedine lijekove koji utječu na način razgradnje lijeka Mysildecard u tijelu.
In adults, Mysildecard is taken at a dose of 20 mg three times a day.
U odraslih osoba lijek Mysildecard uzima se u dozi od 20 mg tri puta na dan.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Mysildecard have been included in the summary of product characteristics and the package leaflet.
Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Mysildecard nalaze se u sažetku opisa svojstava lijeka i u uputi o lijeku.
When it is blocked, a substance called ‘cyclic guanine monophosphate' (cGMP) cannot be broken down, so that it remains in the vessels where it causes relaxation and widening of the blood vessels.
Nakon što se enzim inhibira, tvar „ciklički gvanozin monofosfat” (cGMP) ne može se rastaviti te zbog toga ostaje u krvnim žilama, u kojima uzrokuje opuštanje i širenje krvnih žila.