FrancophonIA/ELRC3.0 huggingface dataset:
English: In a double-blind, randomized, multi-centre, placebo-controlled, 12-week study (n=176, 97 male and 79 female) followed by a 40-week (n=173, 96 male and 77 female), open-label, rosuvastatin dosetitration phase, patients 10-17 years of age (Tanner stage II-V, females at least 1 year postmenarche) with heterozygous familial hypercholesterolaemia received rosuvastatin 5, 10 or 20 mg or placebo daily for 12 weeks and then all received rosuvastatin daily for 40 weeks.
Slovenian: V dvojno slepi, randomizirani, multicentrični, s placebom kontrolirani 12-tedenski študiji (n = 176, 97 fantov in 79 deklet), ki ji je sledila 40-tedenska odprta faza s titriranjem odmerka rosuvastatina (n = 173, 96 fantov in 77 deklet), so bolniki v starosti od 10 do 17 let (s stopnjo od II do V po Tannerju, dekleta vsaj 1 leto po menarhi) s heterozigotno družinsko hiperholesterolemijo dobivali 5, 10 ali 20 mg rosuvastatina ali placeba na dan 12 tednov potem pa so vsi dobivali rosuvastatin vsak dan 40 tednov.
English: AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTIONS OF THE SUMMARY OF PRODUCT CHARACTERISTICS FOR CRESTOR AND ASSOCIATED NAMES
Slovenian: SPREMEMBE KI BODO VKLJUČENE V USTREZNA POGLAVJA POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA CRESTOR IN Z NJIM POVEZANIH IMEN
English: Children and adolescents should be placed on standard cholesterol-lowering diet before rosuvastatin treatment initiation; this diet should be continued during rosuvastatin treatment.
Slovenian: Pred uvedbo zdravljenja z rosuvastatinom je treba otrokom in mladostnikom predpisati standardno dieto za znižanje holesterola, ki jo morajo nadaljevati tudi med zdravljenjem z rosuvastatinom.
English: AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTIONS OF THE PACKAGE LEAFLET FOR CRESTOR AND ASSOCIATED NAMES
Slovenian: SPREMEMBE KI BODO VKLJUČENE V USTREZNA POGLAVJA NAVODILA ZA UPORABO ZDRAVILA CRESTOR IN Z NJIM POVEZANIH IMEN
English: Homozygous familial hypercholesterolaemia as an adjunct to diet and other lipid lowering treatments (e.g. LDL apheresis) or if such treatments are not appropriate.
Slovenian: Homozigotna družinska hiperholesterolemija pri odraslih - kot dodatek dieti in drugim ukrepom za zmanjšanje vrednosti lipidov (npr. afereza LDL) ali kadar ti ukrepi niso primerni.
English: At the end of the 40-week, open-label, titration to goal, dosing up to a maximum of 20 mg once daily, 70 of 173 patients (40.5%) had achieved the LDL-C goal of less than 2.8 mmol/l.
Slovenian: Na koncu 40-tedenske odprte faze s titriranjem do cilja, je z odmerkom do največ 20 mg enkrat na dan, 70 od 173 bolnikov (40,5 %) doseglo ciljni holesterol LDL manj kot 2,8 mmol/l.
English: After 24 months of treatment with rosuvastatin, the LS mean percent reduction from the baseline value in LDL-C was -43% (Baseline: 236 mg/dL, Month 24: 133 mg/dL).
Slovenian: Po 24 mesecih zdravljenja z rosuvastatinom je bil povprečni odstotek (po metodi najmanjših kvadratov) zmanjšanja holesterola LDL od izhodišča -43 % (izhodišče: 236 mg/dl, 24. mesec: 133 mg/dl).
English: LDL-C was reduced 38.3%, 44.6%, and 50.0% by rosuvastatin 5, 10 and 20 mg, respectively, compared to 0.7% for placebo.
Slovenian: Holesterol LDL se je s 5 mg rosuvastatina znižal za 38,3 %, z 10 mg za 44,6 % in z 20 mg za 50,0 %, s placebom pa za 0,7 %.
English: Patients aged 6 to 9 years (n=64) could titrate to a maximum dose of 10 mg once daily and patients aged 10 to 17 years (n=134) to a maximum dose of 20 mg once daily.
Slovenian: do 9 let (n = 64), so lahko odmerek titrirali do največjega odmerka 10 mg enkrat na dan, bolnikom, starim od 10 do 17 let (n = 134) pa do največjega odmerka 20 mg enkrat na dan.
English: For each age group, the LS mean percent reductions from baseline values in LDL-C were -43% (Baseline: 234 mg/dL, Month 24: 124 mg/dL), -45% (Baseline: 234 mg/dL, 124 mg/dL ), and -35% (Baseline: 241 mg/dL, Month 24: 153 mg/dL) in the 6 to <10, 10 to <14, and 14 to <18 age groups, respectively.
Slovenian: Povprečni odstotki znižanja (po metodi najmanjših kvadratov) holesterola LDL od izhodišča so bili po posameznih skupinah: 6 do < 10 let -43 % (izhodišče: 234 mg/dl, 24. mesec: 124 mg/dl), od 10 do < 14 let -45% (izhodišče: 234 mg/dl, 24. mesec: 124 mg/dl) in od 14 do < 18 let -35% (izhodišče: 241 mg/dl, 24. mesec: 153 mg/dl).
English: • In children 10 to 17 years of age with heterozygous familial hypercholesterolaemia, the usual dose range is 5-20 mg orally once daily.
Slovenian: • Za otroke, stare od 10 do 17 let, s heterozigotno družinsko hiperholesterolemijo, je običajen razpon odmerkov od 5 do 20 mg peroralno enkrat na dan.
English: • In children 6 to 9 years of age with heterozygous familial hypercholesterolaemia, the usual dose range is 5-10 mg orally once daily.
Slovenian: • Za otroke, stare od 6 do 9 let, s heterozigotno družinsko hiperholesterolemijo, je običajen razpon odmerkov od 5 do 10 mg peroralno enkrat na dan.
English: After two years of study treatment, no effect on growth, weight, BMI or sexual maturation was detected (see Section 5.1).
Slovenian: Po dveh letih zdravljenja v študiji niso odkrili nobenih učinkov na rast, telesno maso, ITM ali spolno dozorevanje (glejte poglavje 5.1).
English: Amendments to the Summary of Product Characteristics and Package Leaflet
Slovenian: Spremembe Povzetka glavnih značilnosti zdravila in Navodila za uporabo,
English: How to take CRESTOR [Existing information on the paediatric population should be replaced with the following:]
Slovenian: 5.2 Farmakokinetične lastnosti [Obstoječe informacije glede pediatrične populacije se zamenjajo s sledečimi:]
English: After 52 weeks of study treatment, no effect on growth, weight, BMI or sexual maturation was detected (see Section 4.4).
Slovenian: Po 52 tednih zdravljenja v študiji niso odkrili nobenih učinkov na rast, telesno maso, ITM ali spolno dozorevanje (glejte poglavje 4.4).
English: At study entry, approximately 30% of the patients were 10-13 years and approximately 17%, 18%, 40%, and 25% were Tanner stage II, III, IV, and V, respectively.
Slovenian: Ob vključitvi v študijo je bilo približno 30 % bolnikov starih od 10 do 13 let, porazdelitev po stopnjah po Tannerju pa je bila: približno 17 % II.
English: What CRESTOR is and what it is used for [Existing wording of this section should be replaced with the following:] CRESTOR belongs to a group of medicines called statins.
Slovenian: Zdravilo CRESTOR spada v skupino zdravil, imenovanih statini.
English: [Existing information on the paediatric population should be replaced with the following:]
Slovenian: [Obstoječe informacije tega poglavja se zamenjajo s sledečimi:]
English: You should continue with your cholesterol-lowering diet and exercise while you are taking CRESTOR.
Slovenian: Medtem, ko jemljete zdravilo CRESTOR, bi morali nadaljevati z dieto za zniževanje holesterola in telesno vadbo.
English: Paediatric population Paediatric use should only be carried out by specialists.
Slovenian: Otroke mora zdraviti specialist.
English: 5.2 Pharmacokinetic properties [Existing information on the paediatric population should be replaced with the following:] Paediatric population: Two pharmacokinetic studies with rosuvastatin (given as tablets) in paediatric patients with heterozygous familial hypercholesterolaemia 10-17 or 6-17 years of age (total of 214
Slovenian: Pediatrična populacija: Dve farmakokinetični študiji z rosuvastatinom (danim v obliki tablet) pri pediatričnih bolnikih s heterozigotno družinsko hiperholesterolemijo, starih od 10 do 17 ali od 6 do 17 let (skupaj 214 bolnikov), sta pokazali, da je izpostavljenost pediatričnih bolnikov podobna ali manjša kot izpostavljenost odraslih bolnikov.
English: Use in children and adolescents aged 6-17 years
Slovenian: Uporaba pri otrocih in mladostnikih, starih od 6-17 let Priporočeni začetni odmerek je 5 mg.
English: No effect on growth, weight, BMI or sexual maturation was detected after 24 months of treatment (see Section 4.4).
Slovenian: Po 24 mesecih zdravljenja niso ugotovili nobenega vpliva na rast, telesno maso, ITM ali spolno dozorevanje (glejte poglavje 4.4).
English: Children and adolescents 6 to 17 years of age (Tanner Stage <II-V) In children and adolescents with heterozygous familial hypercholesterolaemia the usual start dose is 5 mg daily.
Slovenian: Otroci in mladostniki v starosti od 6 do 17 let (s stopnjo po Tannerju <II-V).
English: The recommended dose is 200 mg once a day for 6 days.
Slovenian: Priporočeni odmerek je 200 mg enkrat dnevno v trajanju šest dni.
English: It works by preventing certain bacteria from making proteins, thereby stopping their growth.
Slovenian: Deluje tako, da določenim bakterijam preprečuje tvorbo beljakovin, s čimer ustavi njihovo rast.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Sivextro on 23 March 2015.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Sivextro, veljavno po vsej Evropski uniji, izdala 23. marca 2015.
English: Although the infections in the studies were not severe, the CHMP considered that the results also apply to severe infections.
Slovenian: Čeprav okužbe, obravnavane v študijah, niso bile hude, je CHMP menil, da rezultati veljajo tudi za hude okužbe.
English: 85.5% of patients treated with Sivextro in the first study and 88.0% in the second study were cured, compared with 86.0% and 87.7% respectively of patients treated with linezolid.
Slovenian: V prvi študiji je bilo ozdravljenih 85,5 % bolnikov, zdravljenih z zdravilom Sivextro, v drugi študiji pa 88,0 %, v primerjavi s 86,0 oz. 87,7 % bolnikov, zdravljenih z linezolidom.
English: Patients who are started on the infusion may be switched to the tablets when appropriate.
Slovenian: Bolniki, ki so začeli zdravljenje z infuzijo, lahko preidejo na tablete, če je to primerno.
English: What measures are being taken to ensure the safe and effective use of Sivextro?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Sivextro?
English: This is a summary of the European public assessment report (EPAR) for Sivextro.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Sivextro.
English: The full EPAR and risk management plan summary for Sivextro 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) in povzetek načrta obvladovanja tveganj za zdravilo Sivextro sta na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: In both studies, the main measure of effectiveness was the number of patients whose infection was cured after treatment.
Slovenian: Glavno merilo učinkovitosti v obeh študijah je bilo število bolnikov, pri katerih je bila okužba po zdravljenju odpravljena.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Sivextro's benefits are greater than its risks and recommended that it be approved for use in the EU.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da so koristi zdravila Sivextro večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
English: Other information about Sivextro
Slovenian: Druge informacije o zdravilu Sivextro
English: In both studies patients received 6 days of treatment with Sivextro which was compared with a 10-day treatment of linezolid.
Slovenian: V obeh študijah so bili bolniki šest dni zdravljeni z zdravilom Sivextro, to zdravljenje pa so primerjali z 10-dnevnim zdravljenjem z linezolidom.
English: A risk management plan has been developed to ensure that Sivextro is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila Sivextro je bil pripravljen načrt obvladovanja tveganj.
English: The active substance in Sivextro, tedizolid, is a type of antibiotic called an oxazolidinone.
Slovenian: Zdravilna učinkovina v zdravilu Sivextro, tedizolid, je vrsta antibiotika, ki ga imenujemo oksazolidinon.
English: What are the risks associated with Sivextro?
Slovenian: Kakšna tveganja so povezana z zdravilom Sivextro?
English: What is Sivextro and what is it used for?
Slovenian: Kaj je zdravilo Sivextro in za kaj se uporablja?
English: What benefits of Sivextro have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Sivextro izkazalo v študijah?
English: Sivextro's safety profile is comparable to that of linezolid and was considered acceptable.
Slovenian: Varnostni profil zdravila Sivextro je podoben varnostnemu profilu linezolida in je bil ocenjen za sprejemljivega.
English: Sivextro was at least as effective as linezolid at curing the infection.
Slovenian: Zdravilo Sivextro je bilo pri ozdravljenju okužbe vsaj tako učinkovito kot linezolid.
English: In light of the need for new antibiotics targeting multi-resistant bacteria, especially those available as an oral (given by mouth) formulation, the CHMP concluded that Sivextro could be a valuable alternative treatment option for bacterial infections of the skin and of skin structures.
Slovenian: Glede na potrebo po novih antibiotikih, ki bi bili učinkoviti proti bakterijam, odpornim na več zdravil, še zlasti takih za peroralno uporabo, je CHMP zaključil, da bi zdravilo Sivextro lahko bila dragocena alternativna možnost zdravljenja bakterijskih okužb kože in kožnih struktur.
English: It is not intended to provide practical advice on how to use Sivextro.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: For the full list of all side effects and restrictions with Sivextro, see the package leaflet.
Slovenian: Za celoten seznam vseh neželenih učinkov in omejitev pri uporabi zdravila Sivextro glejte navodilo za uporabo.
English: Sivextro has been shown to work against bacteria (such as methicillin resistant Staphylococcus aureus (MRSA)) for which standard antibiotics do not work.
Slovenian: Zdravilo Sivextro je dokazano učinkovito proti bakterijam (na primer proti na meticilin odporni bakteriji Staphylococcus aureus (MRSA)), proti katerim običajni antibiotiki ne delujejo.
English: It contains the active substance tedizolid.
Slovenian: Vsebuje zdravilno učinkovino tedizolid.
English: Before using Sivextro, doctors should consider official guidance on the appropriate use of antibiotics.
Slovenian: Preden zdravnik predpiše zdravilo Sivextro, mora pretehtati njegovo uporabo glede na uradne smernice za ustrezno uporabo antibiotikov.
English: The most common side effects with Sivextro (which may affect between 2 and 7 people in 100) are nausea (feeling sick), headache, diarrhoea and vomiting.
Slovenian: Najpogostejši neželeni učinki zdravila Sivextro (ki lahko prizadenejo od 2 do 7 oseb od 100) so slabost, glavobol, driska in bruhanje.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Sivextro, including the appropriate precautions to be followed by healthcare professionals and patients.
Slovenian: V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila Sivextro in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
English: Sivextro was compared with linezolid (another oxazolidinone) in two main studies involving a total of 1,333 patients with acute bacterial infections of the skin and of skin structures, such as cellulitis, skin abscesses and wound infections.
Slovenian: Zdravilo Sivextro so primerjali z linezolidom (drugim oksazolidinonom) v dveh glavnih študijah, v kateri je bilo vključenih skupno 1 333 bolnikov z akutnimi bakterijskimi okužbami kože in kožnih struktur, kot so celulitis, kožni abscesi in okužbe ran.
English: A list of bacteria against which Sivextro is active can be found in the summary of product characteristics (also part of the EPAR).
Slovenian: Seznam bakterij, proti katerim je zdravilo Sivextro učinkovito, je na voljo v povzetku glavnih značilnosti zdravila (ki je prav tako del EPAR).
English: For more information about treatment with Sivextro, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Sivextro preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: Sivextro is available as a powder to be made up into a solution for infusion (drip) into a vein and as tablets (200 mg).
Slovenian: Zdravilo Sivextro je na voljo v obliki praška za pripravo raztopine za infundiranje (kapalne infuzije v veno) in v obliki tablet (200 mg).
English: Why is Sivextro approved?
Slovenian: Zakaj je bilo zdravilo Sivextro odobreno?
English: Sivextro is an antibiotic used in adults to treat acute (short-term) bacterial infections of the skin and of skin structures (tissue below the skin) such as cellulitis (inflammation of the deep skin tissue), skin abscesses and wound infections.
Slovenian: Zdravilo Sivextro je antibiotik, ki se uporablja pri odraslih za zdravljenje akutnih (kratkotrajnih) bakterijskih okužb kože in kožnih struktur (podkožnega tkiva), kot so celulitis (vnetje globokega podkožnega tkiva), kožni abscesi in okužbe ran.
English: Sivextro can only be obtained with a prescription.
Slovenian: Izdaja zdravila Sivextro je le na recept.
English: For practical information about using Sivextro, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Sivextro naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: How does Sivextro work?
Slovenian: Kako zdravilo Sivextro deluje?
English: How is Sivextro used?
Slovenian: Kako se zdravilo Sivextro uporablja?
English: The submission of a revised protocol should take place within 10 days after the Commission Decision.
Slovenian: Vlogo revidiranega protokola je treba predložiti v roku 10 dni po Odločbi Komisije.
English: Condition considered essential for the safe and effective use of the medicinal product including pharmacovigilance
Slovenian: Pogoji, ki so bistveni za varno in učinkovito uporabo zdravila, vključno s farmakovigilanco
English: a prospective observational study aimed to evaluate the prescription recommendations of Mifepristone Linepharma for early pregnancy termination mentioned in the opinion should be performed.
Slovenian: izvedba prospektivne opazovalne študije z namenom oceniti priporočila za predpisovanje zdravila Mifepristone Linepharma za zgodnjo prekinitev nosečnosti.
English: The National Competent Authorities coordinated by the Reference Member State, shall ensure that the following conditions are fulfilled by the MAH:
Slovenian: Pristojni nacionalni organi, ki jih usklajuje referenčna država članica, morajo zagotoviti, da imetnik dovoljenja za promet z zdravilom izpolni naslednje pogoje:
English: Condition of the marketing authorisations
Slovenian: Pogoji dovoljenja za promet z zdravilom
English: The way it works in this disease is not completely understood.
Slovenian: Njen način delovanja pri tej bolezni ni v celoti znan.
English: Treatment is divided into 2 phases: induction and consolidation.
Slovenian: Zdravljenje je razdeljeno na dve stopnji: indukcijsko in konsolidacijsko.
English: Further information on Arsenic trioxide Accord can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/arsenic-trioxide-accord.
Slovenian: Nadaljnje informacije o zdravilu Arzenov trioksid Accord so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/arsenic-trioxide-accord.
English: • Patients with APL whose disease has not responded to previous treatment with a retinoid and cancer medicines, or when their disease has come back after this type of treatment.
Slovenian: • bolnikih z akutno promielocitno levkemijo, katerih bolezen se ni odzvala na predhodno zdravljenje z retinoidi in zdravili za zdravljenje raka ali kadar se je bolezen po taki vrsti zdravljenja ponovila.
English: The infusion should last 1 to 2 hours, but it may need to be given for longer if the patient has certain side effects.
Slovenian: Infuzija mora trajati od ene do dveh ur, če se pri bolniku pojavijo določeni neželeni učinki, pa jo bo morda treba dajati tudi dlje.
English: During the consolidation phase, Arsenic trioxide Accord is given on 5 days each week but the length of breaks between courses and how long it is given for depends on whether patients have received previous treatment or not.
Slovenian: Med konsolidacijsko stopnjo se zdravilo Arzenov trioksid Accord daje pet dni na teden, vendar sta dolžina prekinitev med cikli in trajanje zdravljenja odvisna od tega, ali so bili bolniki predhodno zdravljeni ali ne.
English: The European Medicines Agency concluded that, in accordance with EU requirements, Arsenic trioxide Accord has been shown to be comparable to Trisenox.
Slovenian: Evropska agencija za zdravila je zaključila, da je bilo v skladu z zahtevami EU dokazano, da je zdravilo Arzenov trioksid Accord primerljivo z zdravilom Trisenox.
English: Arsenic trioxide Accord is used to treat adults (aged 18 years or over) with acute promyelocytic leukaemia (APL), a rare form of leukaemia (cancer of the white blood cells) caused by a genetic ‘translocation' (when there is a swap of genes between two chromosomes).
Slovenian: Zdravilo Arzenov trioksid Accord se uporablja za zdravljenje odraslih (starejših od 18 let) z akutno promielocitno levkemijo (APL), tj. redko obliko levkemije (raka belih krvnih celic), ki jo povzroča genetska „translokacija“ (zamenjava genov med dvema kromosomoma).
English: Because Arsenic trioxide Accord is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Slovenian: Ker je zdravilo Arzenov trioksid Accord generično zdravilo, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
English: Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Trisenox, and do not need to be repeated for Arsenic trioxide Accord.
Slovenian: Študije o koristih in tveganjih učinkovine pri odobrenih načinih uporabe so že bile izvedene z referenčnim zdravilom Trisenox, zato jih ni treba ponoviti za zdravilo Arzenov trioksid Accord.
English: During the induction phase, Arsenic trioxide Accord is given every day until there are signs that the treatment is working (when the bone marrow does not contain any leukaemia cells).
Slovenian: Med indukcijsko stopnjo se zdravilo Arzenov trioksid Accord daje vsak dan, dokler se ne pojavijo znaki, da zdravljenje deluje (kostni mozeg ne vsebuje več levkemičnih celic).
English: The translocation affects the way the white blood cells grow, and as a result they lack the ability to use retinoic acid (vitamin A).
Slovenian: Translokacija vpliva na to, kako rastejo bele krvne celice, zaradi česar ne morejo uporabljati retinojske kisline (vitamina A).
English: What measures are being taken to ensure the safe and effective use of Arsenic trioxide Accord?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Arzenov trioksid Accord?
English: As for every medicine, the company provided studies on the quality of Arsenic trioxide Accord.
Slovenian: Tako kot za vsako zdravilo je podjetje predložilo študije o kakovosti zdravila Arzenov trioksid Accord.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Arsenic trioxide Accord have been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Arzenov trioksid Accord upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: Side effects reported with Arsenic trioxide Accord are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Arzenov trioksid Accord, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.