FrancophonIA/ELRC3.0 huggingface dataset:
English: Pale yellow to light yellow, biconvex, oval shaped, film-coated tablets, with “2.5/1000” printed on one side and “4247” printed on the other side, in blue ink.
Slovenian: Komboglyze 2,5 mg/1000 mg filmsko obložene tablete Bledorumene do svetlo rumene, bikonveksne, filmsko obložene tablete, ovalne oblike, ki imajo z modrim črnilom na eni strani natisnjeno oznako "2.5/1000" in na drugi strani oznako "4247".
English: CARTON Komboglyze 2.5 mg/850 mg film-coated tablets
Slovenian: ŠKATLA Komboglyze 2,5 mg/850 mg filmsko obložene tablete
English: The study included patients with renal impairment classified on the basis of creatinine clearance as mild (approximately GFR ≥ 45 to < 90 mL/min), moderate (approximately GFR ≥ 30 to < 45 mL/min), or severe (approximately GFR < 30 mL/min) renal impairment.
Slovenian: Študija je zajela bolnike, pri katerih so okvaro ledvic na podlagi očistka kreatinina razvrstili kot blago (GFR približno ≥ 45 do < 90 ml/min), zmerno (GFR približno ≥ 30 do < 45 ml/min) ali hudo (GFR približno < 30 ml/min).V primerjavi z osebami z normalnim delovanjem ledvic je bila pri bolnikih z blago okvaro ledvic izpostavljenost saksagliptinu 1,2-krat večja in izpostavljenost BMS-510849 1,7-krat večja, z zmerno okvaro ledvic 1,4-krat oz. 2,9-krat večja ter s hudo okvaro ledvic 2,1-krat oz. 4,5-krat večja.
English: Komboglyze 2.5 mg/850 mg film-coated tablets saxagliptin/metformin
Slovenian: Komboglyze 2,5 mg/850 mg filmsko obložene tablete saksagliptin/metformin
English: Saxagliptin twice daily add-on to metformin therapy An add-on to metformin placebo-controlled study of 12-week duration was conducted to evaluate the efficacy and safety of saxagliptin 2.5 mg twice daily in combination with metformin in patients with inadequate glycaemic control (HbA1c 7-10%) on metformin alone.
Slovenian: Saksagliptin dvakrat na dan kot dodatek k zdravljenju z metforminom Pri bolnikih, ki so imeli med monoterapijo z metforminom nezadostno urejeno glikemijo (HbA1c 7-10 %), je bila opravljena 12-tedenska, s placebom kontrolirana, študija za oceno učinkovitosti in varnosti 2,5 mg saksagliptina dvakrat na dan v kombinaciji z metforminom.
English: Immune related findings of minimal, nonprogressive, lymphoid hyperplasia in spleen, lymph nodes and bone marrow with no adverse sequelae have been reported in all species tested at exposures starting from 7 times the RHD.
Slovenian: Pri vseh preskušanih živalskih vrstah so ob izpostavljenostih, ki so se začele s 7-krat tolikšno izpostavljenostjo kot je RHD, opazili imunske spremembe: minimalno, neprogresivno limfoidno hiperplazijo v vranici, bezgavkah in kostnem mozgu, brez neželenih posledic.
English: Each tablet contains 2.5 mg of saxagliptin (as hydrochloride) and 1,000 mg of metformin hydrochloride.
Slovenian: Ena tableta vsebuje 2,5 mg saksagliptina (v obliki klorida) in 1000 mg metforminijevega klorida.
English: CARTON Komboglyze 2.5 mg/1000 mg film-coated tablets
Slovenian: ŠKATLA Komboglyze 2,5 mg/1000 mg filmsko obložene tablete
English: Komboglyze 2.5 mg/1,000 mg film-coated tablets saxagliptin/metformin
Slovenian: Komboglyze 2,5 mg/1000 mg filmsko obložene tablete saksagliptin/metformin
English: Komboglyze 2.5 mg/1,000 mg tablets saxagliptin/metformin HCl
Slovenian: Komboglyze 2,5 mg/1000 mg tablete saksagliptin/metforminijev klorid
English: Light brown to brown, biconvex, round, film-coated tablets, with “2.5/850” printed on one side and “4246” printed on the other side, in blue ink.
Slovenian: Komboglyze 2,5 mg/850 mg filmsko obložene tablete Svetlo rjave do rjave, bikonveksne, okrogle, filmsko obložene tablete, ki imajo z modrim črnilom na eni strani natisnjeno oznako "2.5/850" in na drugi strani oznako "4246".
English: Komboglyze 2.5 mg/850 mg tablets saxagliptin/metformin HCl
Slovenian: Komboglyze 2,5 mg/850 mg tablete saksagliptin/metforminijev klorid
English: Hazard ratio adjusted for baseline renal function category and baseline CVD risk category.
Slovenian: Razmerje ogroženosti, prilagojeno za kategorijo delovanja ledvic izhodiščno in za izhodiščno tveganje za kardiovaskularno bolezen.
English: Change from baseline (adjusted mean (95% Confidence interval [CI]) Difference from saxagliptin + metformin (adjusted mean (95% CI)
Slovenian: Razlika v primerjavi s kombinacijo saksagliptin + metformin (prilagojeno povprečje (95 % IZ)
English: Vitamin B12 deficiency
Slovenian: Presnovne in prehranske motnje laktacidoza zelo redki pomanjkanje vitamina B12
English: Clinical trial data and postmarketing data
Slovenian: Shranjevanje zdravila Komboglyze Vsebina pakiranja in dodatne informacije
English: No dose- and time-dependence was observed in the clearance of saxagliptin and its major metabolite over 14 days of once-daily dosing with saxagliptin at doses ranging from 2.5 mg to 400 mg.
Slovenian: Med 14-dnevno uporabo saksagliptina v odmerkih od 2,5 mg do 400 mg enkrat na dan, niso ugotovili odvisnosti očistka saksagliptina ali njegovega glavnega presnovka bodisi od odmerka bodisi od časa.
English: Komboglyze 2.5 mg/850 mg film-coated tablets saxagliptin/metformin hydrochloride
Slovenian: Komboglyze 2,5 mg/850 mg filmsko obložene tablete saksagliptin/metforminijev klorid
English: Komboglyze 2.5 mg/1000 mg film-coated tablets saxagliptin/metformin hydrochloride
Slovenian: Komboglyze 2,5 mg/1000 mg filmsko obložene tablete saksagliptin/metforminijev klorid
English: The inhibition of plasma DPP4 activity by saxagliptin for at least 24 hours after oral administration of saxagliptin is due to high potency, high affinity, and extended binding to the active site.
Slovenian: Saksagliptin zaradi svoje velike moči, velike afinitete in obsežne vezave na aktivno mesto zavre plazemsko aktivnost DPP4 za vsaj 24 ur po peroralni uporabi.
English: Saxagliptin and dapagliflozin add-on to metformin therapy A total of 534 adult patients with type 2 diabetes mellitus and inadequate glycaemic control on metformin alone (HbA1c 8%-12%), participated in this 24-week randomised, double-blind, active comparator-controlled trial to compare the combination of saxagliptin and dapagliflozin added concurrently to metformin, versus saxagliptin or dapagliflozin added to metformin.
Slovenian: Dodatek saksagliptina in dapagliflozina zdravljenju z metforminom V tem 24-tedenskem randomiziranem, dvojno slepem, z učinkovino kontroliranem preskušanju je sodelovalo skupaj 534 odraslih bolnikov s sladkorno boleznijo tipa 2, ki glikemije niso imeli ustrezno urejene s samim metforminom (HbA1c od 8 do 12 %).
English: Komboglyze 2.5 mg/850 mg film-coated tablets Polyvinyl alcohol
Slovenian: Komboglyze 2,5 mg/850 mg filmsko obložene tablete Polivinilalkohol makrogol 3350
English: Study CV181168 (n=315)
Slovenian: Dodatek 5 mg saksagliptina na dan kombinaciji metformina in dapagliflozina: študija CV181168 (n = 315)
English: Study D1680L00006 (n=257) Saxa 5 mg daily add-on to metformin plus dapagliflozin
Slovenian: Dodatek 5 mg saksagliptina na dan kombinaciji metformina in sulfonilsečnine; študija D1680L00006 (n = 257)
English: Package size l t o r
Slovenian: Zdravilo nim a veā dovoljenja za prom et
English: Pharmaceutical Form
Slovenian: Številka EU Izmišljeno ime jakost farmacevtska oblika pot uporabe ovojnina velikost pakiranja
English: Zonegran zonisamide
Slovenian: Zonegran zonisamid
English: It is available as capsules (25, 50 and 100 mg) and orodispersible tablets (25, 50, 100 and 300 mg).
Slovenian: Na voljo je v obliki kapsul (25, 50 in 100 mg) in orodisperzibilnih tablet (25, 50, 100 in 300 mg).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Zonegran on 10 March 2005.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Zonegran, veljavno po vsej Evropski uniji, odobrila dne 10. marca 2005.
English: The full EPAR for Zonegran can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Zonegran je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: These channels transmit electrical impulses between nerve cells.
Slovenian: Ti kanalčki prenašajo električne impulze med živčnimi celicami.
English: Before stopping Zonegran, the dose should be decreased gradually.
Slovenian: Pred prekinitvijo jemanja zdravila Zonegran je treba odmerek zmanjševati postopoma.
English: The percentage of patients on carbamazepine who were seizure-free for six months was 74.7%.
Slovenian: Delež bolnikov, ki so se zdravili s karbamazepinom in so bili šest mesecev brez napadov, je bil 74,7 %.
English: This document is a summary of the European public assessment report (EPAR) for Zonegran.
Slovenian: Ta dokument je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Zonegran.
English: Other information about Zonegran:
Slovenian: Druge informacije o zdravilu Zonegran:
English: Dose increases may need to be made less frequently in patients with liver or kidney problems or those taking certain other medicines.
Slovenian: Odmerek bo morda treba manj pogosto povečevati pri bolnikih s težavami z jetri ali ledvicami ali tistih, ki jemljejo določena druga zdravila.
English: Two other main studies, one involving 351 adults and one involving 207 children (between 6 and 17 years old), looked at Zonegran as an add-on to existing treatment.
Slovenian: V dveh drugih glavnih študijah, eni s 351 odraslimi in drugi z 207 otroci (starimi od 6 do 17 let), so proučevali zdravilo Zonegran kot dodatek obstoječemu zdravljenju.
English: What benefit has Zonegran shown during the studies?
Slovenian: Kakšne koristi je zdravilo Zonegran izkazalo med študijami?
English: For more information about treatment with Zonegran, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Zonegran preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: 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 Zonegran.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Zonegran, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: The total dose must not exceed 500 mg a day.
Slovenian: Skupni odmerek ne sme preseči 500 mg na dan.
English: The CHMP decided that Zonegran's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: CHMP je zaključil, da so koristi zdravila Zonegran večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
English: What is the risk associated with Zonegran?
Slovenian: Kakšna tveganja so povezana z zdravilom Zonegran?
English: Zonegran can cause heatstroke and de-hydration, particularly in children, and these need to be treated promptly.
Slovenian: Zdravilo Zonegran lahko povzroči srčni napad in dehidracijo, zlasti pri otrocih, kar zahteva takojšnje ukrepanje.
English: Severe rashes have occurred in patients taking Zonegran, including cases of Stevens-Johnson syndrome (a severe, life-threatening type of allergic reaction affecting the skin and mucous membranes).
Slovenian: Pri bolnikih, ki so jemali zdravilo Zonegran, so se pojavili hudi izpuščaji, med drugim tudi primeri Stevens-Johnsonovega sindroma (hude, življenjsko nevarne vrste alergijske reakcije, ki prizadene kožo in sluznico).
English: The most common side effects with Zonegran (seen in more than 1 patient in 10) are loss of appetite, agitation, irritability, confusion, depression, ataxia (an inability to co-ordinate muscle movements), dizziness, memory impairment, somnolence (sleepiness), diplopia (double vision) and decreased blood bicarbonate levels; although the safety profile is similar in children and adults, some side effects are reported more frequently in children than in adults.
Slovenian: Najpogostejši neželeni učinki zdravila Zonegran (opaženi pri več kot 1 bolniku od 10) so izguba teka, vznemirjenost, razdražljivost, zmedenost, depresija, ataksija (nezmožnost koordinacije gibov mišic), omotica, izguba spomina, somnolenca (zaspanost), diplopija (dvojni vid) in znižane ravni bikarbonata v krvi.
English: Zonisamide works by blocking specific pores on the surface of nerve cells called sodium channels and calcium channels.
Slovenian: Zonisamid deluje tako, da zapre točno določene pore na površini živčnih celic, imenovane natrijevi in kalcijevi kanalčki.
English: Zonegran was more effective than placebo at reducing the frequency of seizures when used as an ‘addon' to existing treatment.
Slovenian: Zdravilo Zonegran je bilo pri zmanjšanju pogostosti napadov učinkovitejše od placeba, če se je uporabljalo kot dodatek že obstoječemu zdravljenju.
English: After one week the dose may be increased to 50 mg twice a day and then further increased in steps of 100 mg every week, depending on the patient's response.
Slovenian: Po enem tednu se lahko odmerek zdravila poveča na 50 mg dvakrat na dan, nato pa se lahko vsak teden poveča še za dodatnih 100 mg, odvisno od bolnikovega odziva.
English: Zonegran must not be used in people who are hypersensitive (allergic) to zonisamide, to any of the other ingredients, or to sulphonamides (such as some antibiotics).
Slovenian: Zdravila Zonegran ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) zonisamid, katero koli drugo sestavino zdravila ali sulfonamide (kot so npr. nekateri antibiotiki).
English: Zonegran used on its own was compared with carbamazepine, another anti-epileptic medicine, in a main study involving 583 adults newly diagnosed with partial epilepsy.
Slovenian: Zdravilo Zonegran so kot samostojno zdravilo primerjali s karbamazepinom, tj. drugim zdravilom proti epilepsiji, v glavni študiji, ki je vključevala 583 odraslih z nedavno diagnosticiranimi parcialnimi epileptičnimi napadi.
English: The active substance in Zonegran, zonisamide, is an anti-epileptic.
Slovenian: Zdravilna učinkovina v zdravilu Zonegran, zonisamid, je antiepileptik.
English: It is used on its own in newly diagnosed adults and as an ‘add-on' therapy in adults and children aged 6 years and above already receiving other antiepilepsy medicines.
Slovenian: Uporablja se kot samostojno zdravilo pri odraslih z nedavno diagnosticirano boleznijo in kot dodatna terapija pri odraslih in otrocih, starejših od 6 let, ki že jemljejo druga zdravila proti epilepsiji.
English: Adults taking 500 mg Zonegran per day had an average reduction in seizure frequency of 51%, compared with 16% in those taking placebo.
Slovenian: Pri odraslih, ki so jemali 500 mg zdravila Zonegran na dan, je pogostost napadov v povprečju padla za 51 % v primerjavi s 16 % pri tistih, ki so jemali placebo.
English: Zonegran is used to treat patients with partial seizures (epileptic fits starting in one part of the brain), including those who have secondary generalisation (where the seizure subsequently spreads to the whole brain).
Slovenian: Zdravilo Zonegran se uporablja za zdravljenje odraslih s parcialnimi napadi (epileptičnimi napadi, ki se začnejo v določenem delu možganov), vključno s tistimi s sekundarno generalizacijo (pri kateri se napad sčasoma razširi na cele možgane).
English: By blocking these channels, zonisamide prevents the nerve cells from synchronising their activity and prevents abnormal electrical activity spreading through the brain.
Slovenian: Zonisamid z zaporo teh kanalčkov prepreči, da bi živčne celice časovno uskladile svojo dejavnost, in tako prepreči širjenje nenormalne električne dejavnosti po možganih.
English: Zonegran used on its own was shown to be beneficial in adults with partial seizures: 69.4% of patients on Zonegran were seizure-free for six months.
Slovenian: Zdravilo Zonegran se je kot samostojno zdravilo izkazalo za koristno pri odraslih s parcialnimi napadi: 69,4 % bolnikov, ki so prejemali zdravilo Zonegran, šest mesecev ni imelo napadov.
English: In children, the number of seizures was at least halved in 50% of the patients taking Zonegran, compared with 31% of those taking placebo.
Slovenian: Pri otrocih se je število napadov najmanj prepolovilo pri 50 % bolnikov, ki so jemali zdravilo Zonegran, v primerjavi z 31 % tistih, ki so prejemali placebo.
English: These studies compared Zonegran with placebo (a dummy treatment).
Slovenian: V teh študijah so zdravilo Zonegran primerjali s placebom (zdravilom brez zdravilne učinkovine).
English: The main measure of effectiveness was the proportion of patients who were seizure-free for a period of six months.
Slovenian: Glavno merilo učinkovitosti je bil delež bolnikov, ki v šestih mesecih niso imeli napadov.
English: Zonegran is a medicine that contains the active substance zonisamide.
Slovenian: Zonegran je zdravilo, ki vsebuje zdravilno učinkovino zonisamid.
English: For the full list of all side effects reported with Zonegran, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Zonegran, glejte navodilo za uporabo.
English: After one or two weeks, the daily dose may be increased in steps of 1 mg per kg every one or two weeks until an appropriate dose is reached.
Slovenian: Po enem ali dveh tednih se dnevni odmerek lahko povečuje v eno- ali dvotedenskih razmikih za 1 mg na kg telesne mase, dokler se ne doseže ustrezni odmerek.
English: When Zonegran is used as an ‘add-on' to existing treatment in adults, the recommended starting dose is 25 mg twice a day.
Slovenian: Kadar se zdravilo Zonegran uporablja kot dodatek že obstoječemu zdravljenju odraslih bolnikov, je priporočeni začetni odmerek 25 mg dvakrat na dan.
English: Why has Zonegran been approved?
Slovenian: Zakaj je bilo zdravilo Zonegran odobreno?
English: In the study in children, the main measure of effectiveness was the proportion of patients in whom the number of seizures was at least halved between the 8 weeks before treatment started and the 12-week period when a stable dose was used.
Slovenian: V študiji pri otrocih je bilo glavno merilo učinkovitosti delež bolnikov, pri katerih se je število napadov v 8 tednih pred začetkom zdravljenja do izteka 12-tedenskega obdobja prejemanja stabilnega odmerka vsaj prepolovilo.
English: In the study involving adults, the main measure of effectiveness was the change in the frequency of partial seizures between the 12 weeks before treatment started and the 18-week period when a stable dose was used.
Slovenian: Glavno merilo učinkovitosti je bila sprememba v pogostosti parcialnih napadov v12 tednih pred začetkom zdravljenja do izteka 18-tedenskega obdobja prejemanja stabilnega odmerka.
English: When Zonegran is used on its own in newly diagnosed adults, the recommended starting dose is 100 mg once a day for two weeks, which may be increased by 100 mg at intervals of two weeks.
Slovenian: Kadar se zdravilo Zonegran uporablja kot samostojno zdravilo pri na novo diagnosticiranih odraslih, je priporočeni začetni odmerek v prvih dveh tednih 100 mg enkrat na dan, ki se lahko v dvotedenskih razmikih povečuje za 100 mg. Običajni vzdrževalni odmerek je 300 mg na dan.
English: What is Zonegran used for?
Slovenian: Za kaj se zdravilo Zonegran uporablja?
English: How has Zonegran been studied?
Slovenian: Kako je bilo zdravilo Zonegran raziskano?
English: This reduces the chances of an epileptic fit. Zonegran also acts on the neurotransmitter gamma-aminobutyric acid (GABA, a chemical that allows nerve cells to communicate with each other).
Slovenian: Zdravilo Zonegran deluje tudi na živčni prenašalec gama aminomasleno kislino (spojino GABA, ki omogoča medsebojno sporazumevanje celic), kar lahko pripomore k stabilizaciji električne dejavnosti možganov.
English: How does Zonegran work?
Slovenian: Kako zdravilo Zonegran deluje?
English: How is Zonegran used?
Slovenian: Kako se zdravilo Zonegran uporablja?
English: What is Zonegran?
Slovenian: Kaj je zdravilo Zonegran?
English: The usual maintenance dose is between 300 and 500 mg a day.
Slovenian: Ko je ustrezen odmerek dosežen, se lahko zdravilo Zonegran daje enkrat ali dvakrat na dan. Običajni vzdrževalni odmerek je med 300 in 500 mg na dan.
English: When Zonegran is used as an ‘add-on' to existing treatment in children aged 6 years and above, the dose depends on body weight; the recommended starting dose is 1 mg per kg of body weight daily.
Slovenian: Kadar se zdravila Zonegran uporablja kot dodatek obstoječemu zdravljenju pri otrocih, starejših od 6 let, je odmerek odvisen od telesne mase bolnika.
English: The usual maintenance dose is 300 mg a day.
Slovenian: Priporočeni začetni odmerek je 1 mg na kg telesne mase na dan.
English: The applicant requested a re-examination of the opinion.
Slovenian: Predlagatelj je zaprosil za ponovni pregled mnenja.
English: What were the medicines expected to be used for?
Slovenian: Za kaj naj bi se zdravila uporabljala?
English: They are available as gastroresistant capsules.
Slovenian: Na razpolago so v obliki gastrorezistentnih kapsul.
English: The company that applied for the change to the authorisation is Eli Lilly.
Slovenian: Družba, ki je vložila vlogo za spremembo dovoljenj za promet z zdravilom, je Eli Lilly.
English: How are they expected to work?
Slovenian: Kakšno je njihovo pričakovano delovanje?
English: The full European Public Assessment Report for Ariclaim, Cymbalta and Xeristar can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravil Ariclaim, Cymbalta in Xeristar je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: There was also insufficient evidence that its effect could be maintained over time, which is important when treating a long-term condition.
Slovenian: Prav tako ni bilo zadostnih dokazov, da je ta učinek mogoče vzdrževati dlje časa, kar je pomembno pri zdravljenju dolgotrajnih bolezni.
English: The main measure of effectiveness was the change in the severity of pain, as recorded by the patients on an 11-point scale after 12 or 13 weeks of treatment.
Slovenian: Glavno merilo učinkovitosti je bila sprememba resnosti bolečine, kot so jo vsakodnevno zabeležili bolniki na podlagi 11-točkovne lestvice po 12 ali 13 tednih zdravljenja.
English: What consequences does this refusal have for patients in clinical trials or compassionate use programmes?
Slovenian: Kakšne posledice ima ta zavrnitev za bolnike, ki sodelujejo v kliničnih preskušanjih ali programih sočutne uporabe?
English: Neurotransmitters are chemicals that allow nerve cells to communicate with one another.
Slovenian: Nevrotransmitorji so kemične snovi, ki omogočajo medsebojno komunikacijo živčnih celic.
English: In addition, more information was needed on the effects of duloxetine in elderly patients and its safety in the intended patients including the elderly.
Slovenian: Poleg tega bi potrebovali več podatkov o učinkih duloksetina pri starejših bolnikih in njegovi varnosti za bolnike, ki naj bi jih zdravili, vključno s starejšimi bolniki.
English: The medicines are expected to work in the same way they do in diabetic peripheral neuropathy.
Slovenian: Pričakovano je, da bodo zdravila delovala na enak način, kot delujejo pri diabetični periferni nevropatiji.
English: What were the CHMP's main concerns that led to the refusal of the change to the marketing authorisations?
Slovenian: Kateri so bili glavni zadržki CHMP, ki so privedli do zavrnitve spremembe dovoljenj za promet z zdravili?
English: It does not include pain from internal organs such as the stomach and intestines.
Slovenian: Ne vključuje pa bolečine, ki izvira iz notranjih organov, kot so želodec in prebavila.