natgillin/translations-raw huggingface dataset:
Therefore and in view of the seriousness of the events observed, the PRAC recommended provisional amendments to the product information to contraindicate the use of radium Ra223 dichloride in combination with abiraterone acetate and prednisone/prednisolone and inform on the results of Study ERA 223. 
Odbor PRAC je zato in glede na resnost ugotovljenih dogodkov priporočil začasne spremembe informacij o zdravilu, da se kontraindicira uporaba [223Ra]radijevega diklorida v kombinaciji z abirateron acetatom in prednizonom/prednizolonom ter obvesti o rezultatih študije ERA 223.
Annex IV Scientific conclusions radium Ra223 dichloride 
[223Ra]radijev diklorid
• The PRAC reviewed the preliminary data analyses of Study ERA 223 that suggested an increased risk of fracture and mortality when radium Ra223 dichloride treatment, compared to placebo, is initiated concurrently with abiraterone acetate and prednisone/prednisolone treatment. 
• Odbor PRAC je pregledal analizo predhodnih podatkov študije ERA 223, iz katerih je razvidno večje tveganje zlomov in smrtnosti, če je zdravljenje z [223Ra]radijevim dikloridom, v primerjavi s placebom, začeto sočasno z zdravljenjem z abirateron acetatom in prednizonom/prednizolonom.
The PRAC considered preliminary data analyses from a randomized, placebo-controlled multicentre phase III study (15396/ERA-223) in chemotherapy-naïve patients with asymptomatic or mildly symptomatic castration resistant prostate cancer with bone metastases (CRPC). 
Odbor PRAC je proučil analizo predhodnih podatkov iz randomizirane, s placebom kontrolirane multicentrične klinične raziskave faze III (15396/ERA-223) pri bolnikih z na kastracijo odpornim rakom prostate brez simptomov ali z blagimi simptomi, ki niso bili zdravljeni s kemoterapijo, pri katerih se pojavljajo kostne metastaze.
• In addition, in the absence of definite evidence that the results observed were specific to the combination with abiraterone acetate and prednisone/prednisolone, the PRAC considered that healthcare professionals and patients should be warned that the safety and efficacy of radium Ra223 dichloride in combination with second-generation androgen receptor antagonists including enzalutamide have not been established. 
• Ker ni bilo dokončno dokazano, da so bili ugotovljeni rezultati značilni za kombinacijo z abirateron acetatom in prednizonom/prednizolonom, odbor PRAC prav tako meni, da je treba zdravstvene strokovnjake in bolnike opozoriti, da varnost in učinkovitost [223Ra]radijevega diklorida v kombinaciji z antagonisti androgenskega receptorja druge generacije, vključno z enzalutamidom, nista bili dokazani.
These provisional measures are without prejudice to the outcome of the ongoing review under Article 20 of Regulation (EC) No 
Ti začasni ukrepi ne posegajo v izid potekajočega pregleda v okviru postopka v skladu s členom 20 Uredbe (ES) št. 726/2004.
Healthcare professionals should be informed of the increased incidence of fractures and deaths among patients receiving Xofigo in combination with abiraterone acetate and prednisone/prednisolone compared to patients receiving placebo in combination with abiraterone acetate and prednisone/prednisolone in Study ERA-223, and of the reduced incidence of fractures observed in both treatment arms with concurrent use of bisphosphonates or denosumab bone health agents. 
Zdravstvene delavce je treba obvestiti o povečani incidenci zlomov in smrtnosti med bolniki, ki so prejemali Xofigo v kombinaciji z abirateron acetatom in prednizonom/prednizolonom, v primerjavi z bolniki, ki so prejemali placebo v kombinaciji z abirateron acetatom in prednizonom/prednizolonom v študiji ERA 223, ter o manjši incidenci zlomov, opaženih pri obeh vejah zdravljenja s sočasno uporabo bisfosfonatov ali učinkovin za zdrave kosti, ki jih vsebuje denosumab.
Xofigo (radium Ra223 dichloride, also radium-223 herein) is a centrally authorised product indicated for the treatment of adults with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastases. 
Zdravilo Xofigo (z zdravilno učinkovino [223Ra]radijev diklorid), je zdravilo, odobreno na nacionalni ravni, indicirano za zdravljenje odraslih moških z na kastracijo odpornim rakom prostate, s simptomatskimi kostnimi metastazami in brez znanih metastaz v notranjih organih.
Analyses of uncleaned preliminary data of a clinical trial evaluating Xofigo in combination with abiraterone acetate and prednisone/prednisolone in a patient population with asymptomatic or mildly symptomatic prostate cancer (ERA 223), found that the incidences of treatment emergent fractures and deaths were increased in the treatment arm (radium-223 dichloride plus abiraterone acetate and prednisone/prednisolone) compared to the control arm (placebo plus abiraterone acetate and prednisone/prednisolone). 
Z analizami neprečiščenih predhodnih podatkov o kliničnem preskušanju, ki ocenjuje zdravilo Xofigo v kombinaciji z abirateron acetatom in prednizonom/prednizolonom v populaciji bolnikov brez simptomov ali z blagimi simptomi raka prostate (študija ERA 223), je bilo ugotovljeno, da je incidenca zlomov in smrtnosti, ki jih je povzročilo zdravljenje, povečana pri veji zdravljenja (z [223Ra]radijevim dikloridom v kombinaciji z abirateron acetatom in prednizonom/prednizolonom) v primerjavi s kontrolno vejo (placebo v kombinaciji z abirateron acetatom in prednizonom/prednizolonom).
Based on the available data, Study 15396 shows that in chemotherapy-naïve asymptomatic or mildly symptomatic patients with CRPC, radium-223 in combination with concurrent abiraterone acetate and prednisolone/prednisone decreases overall survival and increases the risk of fractures compared to placebo in combination with abiraterone acetate and prednisone/prednisolone. 
Študija 15396 na podlagi razpoložljivih podatkov kaže, da pri bolnikih z na kastracijo odpornim rakom prostate brez simptomov ali z blagimi simptomi, ki niso bili zdravljeni s kemoterapijo, [223Ra]radijev diklorid v kombinaciji s sočasnim zdravljenjem z abirateron acetatom in prednizonom/prednizolonom, zmanjšuje celokupno preživetje in povečuje tveganje zlomov v primerjavi z zdravljenjem s placebom v kombinaciji z abirateron acetatom in prednizonom/prednizolonom.
Scientific conclusions 
Priloga IV
Abasaglar is given once a day at the same time each day. 
Zdravilo Abasaglar se daje enkrat na dan, vsak dan ob istem času.
This means that Abasaglar is similar to a biological medicine (also known as the ‘reference medicine') that is already authorised in the European Union (EU). 
To pomeni, da je podobno biološkemu zdravilu (t. i. „referenčnemu zdravilu“), ki je že odobreno v Evropski uniji (EU).
What measures are being taken to ensure the safe and effective use of Abasaglar? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Abasaglar?
It is used in adults and children over the age of two for the treatment of diabetes. 
Uporablja se pri odraslih in otrocih, starejših od dveh let, za zdravljenje sladkorne bolezni.
The European Commission granted a marketing authorisation valid throughout the European Union for Abasria on 9 September 2014. 
Evropska komisija je dovoljenje za promet z zdravilom Abasria, veljavno po vsej Evropski uniji, izdala 09. septembra 2014.
The full EPAR and risk management plan summary for Abasaglar can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
Celotno evropsko javno poročilo o oceni zdravila (EPAR) in povzetek načrta obvladovanja tveganj za zdravilo Abasaglar sta na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Reactions at the site of the injection (redness, pain, itching and swelling) and skin reactions (rash) have been seen more often in children than in adults. 
Reakcije na mestu injiciranje (rdečino, bolečino, srbenje in otekanje) ter kožne reakcije (izpuščaj) so pogosteje opažali pri otrocih kot pri odraslih.
It is not intended to provide practical advice on how to use Abasaglar. 
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
Patients can inject themselves with Abasaglar if they have been trained appropriately. 
Bolniki si lahko zdravilo Abasaglar injicirajo sami, če so bili za to ustrezno usposobljeni.
A risk management plan has been developed to ensure that Abasaglar is used as safely as possible. 
Za zagotovitev čim varnejše uporabe zdravila Abasaglar je bil pripravljen načrt obvladovanja tveganj.
This is a summary of the European public assessment report (EPAR) for Abasaglar. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Abasaglar.
The most common side effect with Abasaglar (which may affect more than 1 in 10 people) is hypoglycaemia (low blood glucose). 
Najpogostejši neželeni učinek zdravila Abasaglar (ki lahko prizadene več kot 1 osebo od 10) je hipoglikemija (nizka raven glukoze v krvi).
The site of injection should be changed with each injection to avoid changes to the skin (such as thickening) that can make the insulin work less well than expected. 
Mesto injiciranja je treba ob vsakem injiciranju zamenjati, da se preprečijo spremembe kože (na primer odebelitev), ki lahko povzročijo slabše delovanje insulina od pričakovanega.
The change means that it is absorbed more slowly and regularly by the body after an injection, and that it has a long duration of action. 
Ta razlika pomeni, da se po injiciranju v telesu absorbira počasneje in enakomerneje ter da je njegovo delovanje dolgotrajno.
The name of the medicine was changed to Abasaglar on 3 December 
Ime zdravila je bilo 3. decembra 2014 spremenjeno v Abasaglar.
Average starting HbA1c was 8.3%, and this fell to below 7% in 48.8% of those given Abasaglar, and 52.5% of those given Lantus, with an average percentage point fall of 1.29 and 1.34 respectively. 
Povprečna vrednost HbA1c ob izhodišču je bila 8,3 % in je nato padla pod 7 % pri 48,8 % bolnikov, ki so prejemali zdravilo Abasaglar, in pri 52,5 % bolnikov, ki so prejemali zdravilo Lantus, pri čemer je povprečno znižanje znašalo 1,29 oziroma 1,34 odstotne točke.
Insulin glargine is slightly different from human insulin. 
Insulin glargin se nekoliko razlikuje od človeškega insulina.
The dose is adjusted individually, and the patient's blood glucose (sugar) should be regularly tested to find the lowest effective dose. 
Odmerek se prilagaja posamezniku, pri čemer je treba pri bolniku redno preverjati ravni glukoze (sladkorja) v krvi, da se določi najmanjši učinkoviti odmerek.
Other information about Abasaglar 
Druge informacije o zdravilu Abasaglar
In both studies, the main measure of effectiveness was the change after 6 months of treatment in the level in the blood of a substance called glycosylated haemoglobin (HbA1c), which gives an indication of how well blood glucose is controlled. 
V obeh študijah je bila glavno merilo učinkovitosti sprememba, ki so jo po šestih mesecih zdravljenja zabeležili v ravni snovi v krvi, imenovane glikozilirani hemoglobin (HbA1c), ki odraža uspešnost uravnavanja glukoze v krvi.
Why is Abasaglar approved? 
Zakaj je bilo zdravilo Abasaglar odobreno?
What are the risks associated with Abasaglar? 
Kakšna tveganja so povezana z zdravilom Abasaglar?
Studies were carried out to show that the way Abasaglar is absorbed into the body and the way it acts on blood glucose were similar to Lantus. 
Izvedene so bile študije, v katerih so dokazovali, da sta način absorpcije zdravila Abasaglar v telesu in način njegovega delovanja na glukozo v krvi podobna kot pri zdravilu Lantus.
The active substance in Abasaglar, insulin glargine, is produced by a method known as ‘recombinant DNA technology': it is made by bacteria into which a gene (DNA) has been introduced that makes them able to produce insulin glargine. 
Zdravilna učinkovina v zdravilu Abasaglar, insulin glargin, se proizvaja z metodo, imenovano „tehnologija rekombinantne DNK“, pri kateri so v bakterije vstavili gen (DNK), s katerim lahko tvorijo insulin glargin.
Their average HbA1c before treatment was 7.8% and the average fall after 6 months was similar (0.35% in the Abasaglar group and 0.46% in the Lantus group); 34.5% of those given Abasaglar, and 32.2% of those given Lantus were below the target of 7%. 
Povprečna vrednost HbA1c pri teh bolnikih je bila pred zdravljenjem 7,8 %, povprečno znižanje po šestih mesecih pa je bilo podobno (0,35 % v skupini z zdravilom Abasaglar in 0,46 % v skupini z zdravilom Lantus); pri 34,5 % bolnikov, ki so prejemali zdravilo Abasaglar, in 32,2 % bolnikov, ki so prejemali zdravilo Lantus, so bile vrednosti pod ciljno vrednostjo 7 %.
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that, in accordance with EU requirements for biosimilar medicines, Abasaglar has been shown to have a comparable quality, safety and effectiveness to Lantus. 
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da je bilo v skladu z zahtevami EU glede podobnih bioloških zdravil dokazano, da je zdravilo Abasaglar po kakovosti,
Diabetes is a disease in which the body does not produce enough insulin to control the level of blood glucose. 
Sladkorna bolezen je bolezen, pri kateri v telesu ne nastaja dovolj insulina za uravnavanje ravni glukoze v krvi.
What is Abasaglar and what is it used for? 
Kaj je zdravilo Abasaglar in za kaj se uporablja?
For more information about treatment with Abasaglar, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Abasaglar preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
What benefits of Abasaglar have been shown in studies? 
Kakšne koristi je zdravilo Abasaglar izkazalo v študijah?
Therefore, the CHMP's view was that, as for Lantus, the benefit outweighs the identified risk. 
Zato je menil, da njegove koristi enako kot pri zdravilu Lantus odtehtajo znana tveganja.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Abasaglar, including the appropriate precautions to be followed by healthcare professionals and patients. 
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila Abasaglar in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
The reference medicine for Abasaglar is Lantus. 
Referenčno zdravilo za zdravilo Abasaglar je zdravilo Lantus.
The replacement insulin acts in same way as naturally produced insulin and helps glucose enter cells from the blood. 
Nadomestni insulin deluje enako kot naravno tvorjeni insulin in pomaga pri prehodu glukoze iz krvi v celice.
For the full list of all side effects and restrictions with Abasaglar, see the package leaflet. 
Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Abasaglar glejte navodilo za uporabo.
For practical information about using Abasaglar, patients should read the package leaflet or contact their doctor or pharmacist. 
Za praktične informacije o uporabi zdravila Abasaglar naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
Abasaglar is available as cartridges and prefilled disposable pens (KwikPen) and can only be obtained with a prescription. 
Zdravilo Abasaglar je na voljo v obliki vložkov in napolnjenih injekcijskih peresnikov za enkratno uporabo (KwikPen) ter se izdaja le na recept.
It is given by injection under the skin in the abdominal wall (tummy), the thigh, or the deltoid region (upper arm). 
Zdravilo se daje z injiciranjem pod kožo v trebušno steno (trebuh), stegno ali deltoidni predel (nadlaket).
Abasaglar is a medicine that contains the active substance insulin glargine. 
Abasaglar je zdravilo, ki vsebuje zdravilno učinkovino insulin glargin.
insulin glargine 
Abasaglar insulin glargin
Abasaglar is a ‘biosimilar medicine'. 
Zdravilo Abasaglar je „podobno biološko zdravilo“.
The Committee recommended that Abasaglar be given marketing authorisation. 
Priporočil je, da se za zdravilo Abasaglar izda dovoljenje za promet.
• In one study, Abasaglar was compared with Lantus when added to short-acting insulin treatment in 536 patients with type 1 diabetes. 
• V eni študiji so zdravilo Abasaglar in zdravilo Lantus, ki so ju dodajali zdravljenju s kratkodelujočim insulinom, primerjali pri 536 bolnikih s sladkorno boleznijo tipa 1.
Abasaglar is a replacement insulin that is very similar to the insulin made by the body. 
Zdravilo Abasaglar je nadomestni insulin, ki je zelo podoben insulinu, ki nastaja v telesu.
Abasaglar can also be given together with diabetes medicines taken by mouth in patients who have type-2 diabetes. 
Zdravilo Abasaglar se lahko pri bolnikih, ki imajo sladkorno bolezen tipa 2, uporablja tudi v kombinaciji z zdravili za zdravljenje sladkorne bolezni, ki se jemljejo skozi usta.
• In the second study, treatment with Abasaglar or Lantus was compared in 759 patients with type 2 diabetes, as an addition to diabetes medicines taken by mouth. 
• V drugi študiji so primerjali zdravilo Abasaglar in zdravilo Lantus, ki so ju dodajali zdravilom za zdravljenje sladkorne bolezni, ki se jemljejo skozi usta, pri 759 bolnikih s sladkorno boleznijo tipa 2.
How is Abasaglar used? 
Kako se zdravilo Abasaglar uporablja?
In addition, treatment with once-daily Abasaglar has been shown to be comparable to the reference medicine, Lantus, in two supportive studies involving a total of 1,295 adults with diabetes. 
Poleg tega sta dve podporni študiji, v katerih je sodelovalo skupno 1 295 odraslih s sladkorno boleznijo, pokazali, da je zdravljenje z zdravilom Abasaglar enkrat na dan primerljivo zdravljenju z referenčnim zdravilom Lantus.
How does Abasaglar work? 
Kako zdravilo Abasaglar deluje?
LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES 
DODATEK I SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, POTI UPORABE ZDRAVILA, PREDLAGATELJEV,IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH
Cineole + Camphor + Gomenol (Niaouli oil) 
Cineol + Kafra + Gomenol (Niaouli oil)
LABORATOIRES JOLLY JATEL 28 avenue Carnot 78951 Saint-Germain en Laye Cedex France 
LABORATOIRES JOLLY JATEL 28 avenue Carnot 78951 Saint-Germain en Laye Cedex
SPINDLER 6, Avenue de l'Europe BP51 
LABORATOIRES MAYOLY SPINDLER 6, Avenue de l'Europe BP51
CAMPHOCAL YPTOL SIMPLE ENFANTS 0,07 g, suppositoire 
CAMPHOCALYPT OL SIMPLE ENFANTS 0,07 g, suppositoire
BI-QUI-NOL ENFANTS, suppositoire camphre racémique, cinéole 
BI-QUI-NOL ENFANTS, suppositoire kafra racémique, cineol
Meda PharmaProdutos farmacêuticos, S.A. Rua do Centro Cultural, 13 1749-066 Lisboa 
Rua do Centro Cultural, 13 1749-066 Lisboa
92503 RUEIL MALMAISON CEDEX 
92503 RUEIL MALMAISON CEDEX France
CAMPHOCAL YPTOL SIMPLE NOURRISSON S 0,06 g, suppositoire 
CAMPHOCALYPT OL SIMPLE NOURRISSONS 0,06 g, suppositoire
OZOTHINE ENFANTS 30 mg, suppositoire terebenthine (huile essentielle de) 
OZOTHINE ENFANTS 30 mg, suppositoire eterično olje iz terpentina
Lipobalsamo Eucalyptol/ guaiacol 
Eucalyptol/ guaiakol
Ozopulmin Oxidation product of turpentine/pine essential oil 
Ozopulmin oksidacijski produkt terpentina / Eterično olje bora
HEXAPNEUMI NE 
BRONCHODERMI NE
BRONCHOREC TINE AU CITRAL ENFANTS, suppositoire terpinol, pin, serpolet 
BRONCHORECTIN E AU CITRAL ENFANTS, suppositoire terpineol, bor, serpolet
1-13 boulevard Romain Rolland 75014 Paris France 
1-13 boulevard Romain Rolland
eucalyptus huile essentielle thiophene carboxylate paracetamo 
eterično olje iz evkaliptusa thiophene carboxylate paracetamol
BRONCHOREC TINE AU CITRAL NOURRISSON S, suppositoire terpinol, pin, serpolet 
BRONCHORECTIN E AU CITRAL NOURRISSONS, suppositoire terpineol, bor , serpolet
Eucalyptine Lebrun eucalyptol inn:codéine phosphate 
Eucalyptine Lebrun evkaliptol codéine phosphate
Trophires Enfants eucalyptus huile essentielle thiophene carboxylate paracetamo 
Trophires Enfants eterično olje iz evkaliptusa thiophene carboxylate paracetamol
Camphor + Eucalyptol + Menthol 
Kafra + Evkaliptol + Mentol
EucalyptinePholcodine Enfants camphre eucalyptol gaiacol phenol pholcodine 
Eucalyptine Pholcodine Child kafra evkaliptol guaiacol pholcodine phenol
Trophires Compose Nourrissons paracetamol essence d'eucalyptus tenoate de sodium 
Trophires Compose Nourrissons paracetamol eterično olje iz evkaliptusa tenoate de sodium
TERPONE ENFANTS, suppositoire niaouli, huile essentielle d'eucalyptus, terpine, huile essentielle d'aiguilles de pin de siberie 
TERPONE ENFANTS, suppositoire niaouli, eterično olje iz evkaliptusa, terpin, eterično olje bora
FEBRECTOL ENFANTS, suppositoire pin 
FEBRECTOL ENFANTS, suppositoire bor
TERPONE NOURRISSON S, suppositoire niaouli, huile essentielle d'eucalyptus, terpine, huile essentielle d'aiguilles de pin de siberie 
TERPONE NOURRISSONS, suppositoire niaouli, eterično olje iz evkaliptusa, terpin, eterično olje bora
TROPHIRES NOURRISSON S, suppositoire huile essentielle d'eucalyptus 
TROPHIRES NOURRISSONS, suppositoire eterično olje iz evkaliptusa
BRONCHODE RMINE ENFANTS, suppositoire cinéole, huile essentielle de pin 
BRONCHODERMI NE ENFANTS, suppositoire cineol, eterično olje bora
TROPHIRES COMPOSE ENFANTS, suppositoire huile essentielle d'eucalyptus 
TROPHIRES COMPOSE ENFANTS, suppositoire eterično olje iz evkaliptusa
FEBRECTOL NOURRISSON S, suppositoire pin 
FEBRECTOL NOURRISSONS, suppositoire bor
BOUCHARA RECORDATI 38 rue MarjolinBP67 
BOUCHARA RECORDATI 38 rue Marjolin - BP67 92302 Levallois-Perret Cedex
TROPHIRES ENFANTS, suppositoire huile essentielle d'eucalyptus 
TROPHIRES ENFANTS, suppositoire eterično olje iz evkaliptusa
30,500 28802 Alcalá de Henares (Madrid) Spain 
Alcalá de Henares (Madrid)
Trophires Bebes eucalyptus huile essentielle tenuate de sodium 
Trophires Bebes eterično olje iz evkaliptusa tenuate de sodium
TROPHIRES COMPOSE NOURRISSON S, suppositoire huile essentielle d'eucalyptus 
TROPHIRES COMPOSE NOURRISSONS, suppositoire eterično olje iz evkaliptusa
DIPROPHYLLI NE ENFANTS, suppositoire terebenthine (huile essentielle de) 
OZOTHINE A LA DIPROPHYLLINE ENFANTS, suppositoire eterično olje iz terpentina
Eucalyptine camphora inn:eucalyptol inn:guaiacol 
Eucalyptine kafra evkaliptol guaiacol
BRONCHODE RMINE NOURRISSON S, suppositoire cinéole, huile essentielle de pin 
NOURRISSONS, suppositoire cineol, eterično olje bora
This can lead to weakness or even paralysis. 
Posledica tega je lahko oslabelost ali celo paraliza.
Overall Population (n=237) 
Vsa populacija (n = 237)
Carcinogenicity studies have not been performed. 
Raziskave kancerogenosti niso bile izvedene.
The powder will not dissolve. 
Prašek se ne bo raztopil.
It should not be taken in its dry form. 
Ne sme se ga zaužiti v suhi obliki.
Elderly population (≥65 years of age) 
Starejša populacija (starost ≥ 65 let)
Long term exposure 
Dolgoročna izpostavljenost
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 19 July 2017 
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve: 19 julij 2017
Clinical trials with patiromer have not included exposure longer than one year. 
Klinični preskusi s patiromerom niso vključevali izpostavljenosti, daljše od enega leta.
The safety and efficacy of Veltassa in children aged under 18 years have not yet been established. 
Varnost in učinkovitost zdravila Veltassa pri otrocih, starih manj kot 18 let, še nista bili dokazani.
4.5 Interaction with other medicinal products and other forms of interaction Effect of patiromer on other medicinal products 
4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Vpliv patiromera na druga zdravila
Effect of Food 
Vpliv hrane
Study Visit (week) 
Obisk v okviru študije (teden)
Too much potassium in the blood can affect how your nerves control your muscles. 
Preveč kalija v krvi lahko vpliva na to, kako živci nadzirajo mišice.
• if you are allergic to patiromer or any of the other ingredients of this medicine (listed in section 6). 
• če ste alergični na patiromer ali katero koli sestavino tega zdravila (navedeno v poglavju 6).