FrancophonIA/ELRC3.0 huggingface dataset:
English: One ml provides 50 mg of daptomycin after reconstitution with 7 ml of sodium chloride 9 mg/ml (0.9%) solution.
Slovenian: En mililiter po rekonstituciji s 7 ml 0,9-odstotne (9 mg/ml) raztopine natrijevega klorida vsebuje 50 mg daptomicina.
English: One ml provides 50 mg of daptomycin after reconstitution with 10 ml of sodium chloride 9 mg/ml (0.9%) solution.
Slovenian: En mililiter po rekonstituciji z 10 ml 0,9-odstotne (9 mg/ml) raztopine natrijevega klorida vsebuje 50 mg daptomicina.
English: You should not be given Daptomycin Hospira
Slovenian: Shranjevanje zdravila Daptomicin Hospira
English: Comparator
Slovenian: Odmerjanje
English: - Adult and paediatric (1 to 17 years of age) patients with complicated skin and soft-tissue infections (cSSTI).
Slovenian: Daptomicin je indiciran za zdravljenje naslednjih okužb (glejte poglavji 4.4 in 5.1): - pri odraslih in pediatričnih bolnikih (starih od 1 do 17 let) z zapletenimi okužbami kože in mehkih tkiv (cSSTI - Complicated Skin and Soft Tissue Infections).
English: Daptomycin Hospira 500 mg powder for solution for injection/infusion Powder for solution for injection/infusion.
Slovenian: Daptomicin Hospira 500 mg prašek za raztopino za injiciranje/infundiranje daptomicin i.v.
English: STATEMENT OF ACTIVE SUBSTANCE(S)
Slovenian: podaljšanje protrombinskega časa (PČ)
English: Scientific conclusions, grounds for variation to the terms of the marketing authorisations and detailed explanation of the scientific grounds for the differences from the PRAC recommendation
Slovenian: Znanstveni zaključki, podlaga za spremembo pogojev dovoljenj za promet z zdravilom ter podrobna obrazložitev znanstvenih razlogov za odstopanja od
English: EU Number Invented name Strength Pharmaceutical form Route of administration Packaging Content (concentration) Package size EU/1/99/122/001 Thyrogen
Slovenian: Vsebina (koncentracija)
English: 3 hours before taking the other.
Slovenian: 3 ure, preden vzamete drugo.
English: They are packed in bottles.
Slovenian: Pakirane so v stekleničkah.
English: After taking one of them, wait at least 2 to
Slovenian: Po zaužitju enega od teh zdravil počakajte vsaj 2 do
English: Date of first authorisation: 22 September 1998 Date of latest renewal: 03 September 2008
Slovenian: Datum prve odobritve: 22. september 1998 Datum zadnjega podaljšanja: 03. september 2008
English: • if you have ever had a heart attack or any other diseases of the heart;
Slovenian: • če ste že kdajkoli imeli srčni napad ali katero od drugih bolezni srca;
English: Comtan and iron supplements at the same time.
Slovenian: Comtan in dodatkov železa istočasno.
English: • uncontrollable excessive shopping or spending.
Slovenian: • neobvladljivo prekomerno nakupovanje ali zapravljanje;
English: [carton only] PC:
Slovenian: [samo škatla] PC:
English: • if you are taking certain antidepressants (ask your doctor or pharmacist whether your antidepressive medicine can be taken together with Comtan);
Slovenian: • če jemljete določene antidepresive (povprašajte svojega zdravnika ali farmacevta, ali lahko jemljete svoje zdravilo proti depresiji skupaj z zdravilom Comtan);
English: The pharmacokinetic properties of entacapone are similar in both young people and older people.
Slovenian: Farmakokinetične lastnosti entakapona so podobne tako pri mlajših kot pri starejših osebah.
English: If this happens, you should not drive or use any tools or machines (see “Driving and using machines”).
Slovenian: Če se vam to dogaja, ne smete voziti ali uporabljati naprav ali strojev (glejte “Vpliv na sposobnost upravljanja vozil in strojev”).
English: A small amount of entacapone, the (E)-isomer, is converted to its (Z)-isomer.
Slovenian: Majhna količina entakapona, izomer (E), se spremeni v njegov izomer (Z).
English: • altered or increased sexual interest and behaviour of significant concern to you or to others, for example, an increased sexual drive.
Slovenian: • spremenjeno ali povečano zanimanje za spolnost in zaskrbljujoče spolno vedenje, na primer povečano spolno slo;
English: Approximately 10-20% is excreted in urine.
Slovenian: Približno 10-20 % odmerka se izloča z urinom.
English: Elderly (≥65 years) No dosage adjustment of entacapone is required for older people.
Slovenian: Starejši (≥65 let) Za starejše ljudi ni potrebno prilagajanje odmerjanja entakapona.
English: There are three different pack sizes (bottles containing 30, 60, or 100 tablets).
Slovenian: Obstajajo tri različne velikosti pakiranj (stekleničke, ki vsebujejo po 30, 60 ali 100 tablet).
English: [carton only]
Slovenian: [samo škatla]
English: EU/1/98/081/001 30 film-coated tablets (glass) EU/1/98/081/002 60 film-coated tablets (glass) EU/1/98/081/003
Slovenian: EU/1/98/081/001 30 filmsko obloženih tablet (steklo) EU/1/98/081/002 60 filmsko obloženih tablet (steklo) EU/1/98/081/003 100 filmsko obloženih tablet (steklo) EU/1/98/081/005 30 filmsko obloženih tablet (HDPE) EU/1/98/081/006
English: • strong impulse to gamble excessively despite serious personal or family consequences.
Slovenian: • močno željo po pretiranem igranju iger na srečo kljub resnim posledicam, ki jih ima to lahko za bolnika osebno ali za njegovo družino;
English: The (E)-isomer accounts for 95% of the AUC of entacapone.
Slovenian: Izomer (E) predstavlja 95 % AUC entakapona.
English: What Comtan is and what it is used for
Slovenian: Kaj je zdravilo Comtan in za kaj ga uporabljamo
English: Other medicines and Comtan
Slovenian: Druga zdravila in zdravilo Comtan
English: If you stop taking Comtan Do not stop taking Comtan unless your doctor tells you to.
Slovenian: Če ste prenehali jemati zdravilo Comtan Ne prekinite jemanja zdravila Comtan, razen če vam to naroči vaš zdravnik.
English: The (Z)-isomer and traces of other metabolites account for the remaining 5%.
Slovenian: Izomer (Z) in drugi presnovki v sledovih predstavljajo preostalih 5 %.
English: The safety and efficacy of Comtan in children below age 18 have not been established.
Slovenian: Varnost in učinkovitost zdravila Comtan pri otrocih, starih do 18 let, nista bili dokazani.
English: However, in an interaction study in healthy volunteers, entacapone did not change the plasma levels of S-warfarin, while the AUC for R-warfarin increased on average by 18% [CI90 11-26%].
Slovenian: Vendar v študiji medsebojnega delovanja na zdravih prostovoljcih entakapon ni spremenil plazemskih koncentracij S-varfarina, medtem ko se je AUC za R-varfarin povečala povprečno za 18 % [IZ90
English: Therefore, do not take
Slovenian: Zato ne jemljite zdravila
English: If you experience such effects at the start of treatment with Comtan you should contact your doctor who may decide to adjust your dosage of levodopa.
Slovenian: Če pri vas pride od takih učinkov na začetku zdravljenja z zdravilom Comtan, morate obvestiti zdravnika, ki se bo morda odločil, da vam prilagodi odmerjanje levodope.
English: Therefore, patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
Slovenian: Zato bolniki z redko dedno intoleranco za fruktozo, malabsorpcijo glukoze/galaktoze ali pomanjkanjem saharoza-izomaltaze ne smejo jemati tega zdravila.
English: Do not use Comtan during pregnancy or if you are breast-feeding.
Slovenian: Ne jemljite zdravila Comtan v nosečnosti ali če dojite.
English: Comtan in association with levodopa may have a major influence on the ability to drive and use machines.
Slovenian: Comtan ima skupaj z levodopo pomemben vpliv na sposobnost vožnje in upravljanja strojev.
English: If you forget to take Comtan
Slovenian: Če ste pozabili vzeti zdravilo Comtan
English: Comtan 200 mg [carton only]
Slovenian: Comtan 200 mg [samo škatla]
English: hydrogenated vegetable oil, magnesium stearate.
Slovenian: hidrogenirano rastlinsko olje in magnezijev stearat.
English: What Comtan is and what it is used for What you need to know before you take Comtan How to take Comtan
Slovenian: Kaj je zdravilo Comtan in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Comtan Kako jemati zdravilo Comtan Možni neželeni učinki
English: If you forget to take the Comtan tablet with your levodopa dose, you should continue the treatment by taking the next Comtan tablet with your next levodopa dose.
Slovenian: Če pozabite vzeti tableto Comtan s svojim odmerkom levodope, nadaljujte zdravljenje tako, da vzamete naslednjo tableto Comtan z naslednjim odmerkom levodope.
English: What you need to know before you take Comtan
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Comtan
English: CI95% 45 min, 1 h 56 Study II: Proportion of daily On time (%) Entacapone (n=103) Placebo (n=102)
Slovenian: IZ95 % 45 min, 1h 56 min Študija II: Delež dnevnega obdobja ‘ON' (%) entakapon (n=103)
English: Table 1* Adverse drug reactions
Slovenian: Preglednica 1* Neželeni učinki zdravila
English: If you take more Comtan than you should In the event of an overdose, consult your doctor, pharmacist or the nearest hospital immediately.
Slovenian: Če ste vzeli večji odmerek zdravila Comtan, kot bi smeli Če ste vzeli prevelik odmerek, se takoj posvetujte s svojim zdravnikom, farmacevtom ali najbližjo bolnišnico.
English: • binge eating (eating large amounts of food in a short time period) or compulsive eating
Slovenian: • prenajedanje (uživanje velikih količin hrane v kratkem času) ali kompulzivno prenajedanje (uživanje večjih količin hrane kot običajno oziroma več, kot je potrebno za potešitev lakote).
English: Do not take Comtan
Slovenian: Ne jemljite zdravila Comtan
English: When Comtan is given at higher doses:
Slovenian: Pri uporabi višjih odmerkov zdravila Comtan:
English: - The film-coating contains hypromellose, polysorbate 80, glycerol 85%, sucrose, yellow iron oxide (E172), red iron oxide (E172) and titanium dioxide (E171), magnesium stearate.
Slovenian: - Filmska obloga vsebuje hipromelozo, polisorbat 80, glicerol 85 %, saharozo, rumeni železov oksid (E172), rdeči železov oksid (E172), titanov dioksid (E171) in magnezijev stearat.
English: As Comtan tablets will be taken together with other levodopa medicines, please also read the package leaflets of these medicines carefully.
Slovenian: Ker boste tablete Comtan jemali skupaj z drugimi zdravili z levodopo, skrbno preberite tudi njihova navodila za uporabo.
English: - The other ingredients are microcrystalline cellulose, mannitol, croscarmellose sodium,
Slovenian: - Druge sestavine zdravila so mikrokristalna celuloza, manitol, premreženi natrijev karmelozat,
English: Each tablet contains 1.82 mg sucrose.
Slovenian: Vsaka tableta vsebuje 1,82 mg saharoze.
English: What Comtan contains - The active substance is entacapone.
Slovenian: Kaj vsebuje zdravilo Comtan - Učinkovina je entakapon.
English: Comtan tablets contain entacapone and are used together with levodopa to treat Parkinson's disease.
Slovenian: Tablete Comtan vsebujejo entakapon in jih uporabljamo skupaj z levodopo za zdravljenje Parkinsonove bolezni.
English: Similarly, no interactions between entacapone and selegiline were observed in repeated-dose studies in parkinsonian patients.
Slovenian: Prav tako niso opazili medsebojnega delovanja med entakaponom in selegilinom pri bolnikih s Parkinsonovo boleznijo v študijah s ponavljajočimi odmerki.
English: It is characterised by stiffness, muscle twitching, shaking, agitation, confusion, coma, high body temperature, increased heart rate and unstable blood pressure;
Slovenian: Za NMS so značilni okorelost, trzanje mišic, tresenje, agitacija, zmedenost, koma, zvišana telesna temperatura, pospešen utrip srca in nestabilen krvni tlak;
English: Comtan may make it harder for you to digest iron.
Slovenian: Zdravilo Comtan lahko oteži prebavljanje železa.
English: 30 film-coated tablets 60 film-coated tablets 100 film-coated tablets
Slovenian: 30 filmsko obloženih tablet 60 filmsko obloženih tablet 100 filmsko obloženih tablet
English: Suddenly stopping Comtan and other medicines to treat Parkinson's disease may result in unwanted side effects.
Slovenian: Nenadna prekinitev zdravljenja z zdravilom Comtan in drugimi zdravili za zdravljenje Parkinsonove bolezni lahko povzroči neželene učinke.
English: The daily dose of levodopa should be reduced by about 10-30% by extending the dosing intervals and/or by reducing the amount of levodopa per dose, according to the clinical condition of the patient.
Slovenian: Glede na bolnikovo klinično stanje je treba dnevni odmerek levodope zmanjšati za približno 10-30 %, in sicer s podaljšanjem časovnega presledka med posameznimi odmerki in/ali z zmanjšanjem količine levodope na odmerek.
English: Comtan is taken together with medicines containing levodopa (either levodopa/carbidopa preparations or levodopa/benserazide preparations).
Slovenian: Zdravilo Comtan se jemlje skupaj z zdravili, ki vsebujejo levodopo (bodisi pripravki levodope/karbidope bodisi pripravki levodope/benserazida).
English: The recommended dose of Comtan is one 200 mg tablet with each levodopa dose.
Slovenian: Priporočeni odmerek zdravila Comtan je ena 200-miligramska tableta z vsakim odmerkom levodope.
English: • discolouration of the skin, hair, beard and nails.
Slovenian: • sprememba barve kože, las, brade in nohtov.
English: Entacapone therapy should be administered cautiously to patients with ischaemic heart disease.
Slovenian: Entakapon moramo uporabljati previdno pri zdravljenju bolnikov z ishemično boleznijo srca.
English: Comtan aids levodopa in relieving the symptoms of Parkinson's disease.
Slovenian: Zdravilo Comtan pomaga levodopi pri lajšanju simptomov Parkinsonove bolezni.
English: How to take Comtan
Slovenian: Kako jemati zdravilo Comtan
English: Brownish-orange, oval, biconvex film-coated tablet with “Comtan” engraved on one side.
Slovenian: Rjavkastooranžna, ovalna, bikonveksna filmsko obložena tableta z vtisnjenim napisom “Comtan” na eni strani.
English: Comtan has no effect on relieving the symptoms of Parkinson's disease unless taken with levodopa.
Slovenian: Zdravilo Comtan ne lajša simptomov Parkinsonove bolezni, če ga bolnik ne vzame skupaj z levodopo.
English: Table 2 Daily ON time (Mean ± SD)
Slovenian: Preglednica 2 Dnevno obdobje ‘ON' (povprečje ± S.D.)
English: Usually side effects caused by Comtan are mild to moderate.
Slovenian: Neželeni učinki, ki jih povzroča zdravilo Comtan, so navadno blagi do zmerni.
English: When stopping, your doctor may need to re-adjust the dosage of your other medicines to treat Parkinson's disease.
Slovenian: Pri prekinitvi jemanja vam bo zdravnik mogoče prilagodil odmerjanje drugih vaših zdravil za zdravljenje Parkinsonove bolezni.
English: White high-density polyethylene (HDPE) bottles with white tamper proof polypropylene (PP) closures containing 30, 60 or 100 tablets.
Slovenian: Bele stekleničke iz polietilena visoke gostote (HDPE), z belim polipropilenskim (PP) pokrovčkom, odpornim proti nepooblaščenemu odpiranju, v katerih je po 30, 60 ali 100 tablet.
English: 100 film-coated tablets (glass) 30 film-coated tablets (HDPE) 100 film-coated tablets (HDPE) 60 film-coated tablets (HDPE)
Slovenian: 100 filmsko obloženih tablet (HDPE) 60 filmsko obloženih tablet (HDPE)
English: • Excessive movements (hyperkinesias), worsening of symptoms of Parkinson's disease,
Slovenian: • čezmerni gibi (hiperkinezije), poslabšanje simptomov Parkinsonove bolezni, dolgotrajni mišični krči (distonija);
English: Your doctor may advise you to slowly discontinue the treatment with Comtan and other medicines to treat Parkinson's disease.
Slovenian: Zdravnik vam bo morda svetoval, da zdravilo Comtan in druga zdravila za zdravljenje Parkinsonove bolezni prenehate jemati postopoma.
English: Amber glass bottles (hydrolytic class III) with white tamper-resistant polypropylene closures containing 30, 60 or 100 tablets.
Slovenian: Stekleničke iz temno obarvanega stekla (hidrolizni razred III) z belim pokrovčkom, odpornim proti nepooblaščenemu odpiranju, iz polipropilena, v katerih je po 30, 60 ali 100 tablet.
English: General characteristics of the active substance
Slovenian: Splošne značilnosti učinkovine
English: In addition, Comtan taken with levodopa may make you feel very drowsy, or cause you to sometimes suddenly fall asleep.
Slovenian: Poleg tega lahko zdravilo Comtan, ki ga vzamete skupaj z levodopo, povzroči hudo zaspanost ali povzroči, da včasih nenadoma zaspite.
English: Yellow iron oxide (E172) Red iron oxide (E172) Titanium dioxide (E171)
Slovenian: Filmska obloga hipromeloza polisorbat 80 glicerol 85 % saharoza rumeni železov oksid (E172) rdeči železov oksid (E172) titanov dioksid (E171) magnezijev stearat
English: See Section 4 Possible side effects for the characteristics of NMS;
Slovenian: Za značilnosti NMS glejte poglavje 4 Možni neželeni učinki;
English: Comtan 200 mg film-coated tablets
Slovenian: Comtan 200 mg filmsko obložene tablete
English: Comtan taken together with levodopa may lower your blood pressure, which may make you feel light-headed or dizzy.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Zdravilo Comtan, ki ga jemljete skupaj z levodopo, vam lahko zniža krvni tlak, zaradi česar se vam lahko stemni pred očmi ali postanete omotični.
English: • Comtan taken with levodopa may rarely make you feel very drowsy during the day, and cause you to suddenly fall asleep;
Slovenian: • poredko se lahko zgodi, da zaradi zdravila Comtan, ki ga jemljete z levodopo, postanete čez dan izredno zaspani, lahko tudi povzroči, da nenadoma zaspite;
English: Croscarmellose sodium Hydrogenated vegetable oil Magnesium stearate
Slovenian: Jedro tablete mikrokristalna celuloza manitol natrijev karmelozat, premreženi hidrogenirano rastlinsko olje magnezijev stearat
English: Comtan tablets contain sucrose.
Slovenian: Tablete zdravila Comtan vsebujejo saharozo.
English: Comtan taken with levodopa may cause drowsiness and may cause you to sometimes suddenly fall asleep.
Slovenian: Zdravilo Comtan, ki ga vzamete skupaj z levodopo, lahko povzroča zaspanost ali povzroči, da včasih nenadoma zaspite.
English: Impulse control disorders: Pathological gambling, increased libido, hypersexuality, compulsive spending or buying, binge eating and compulsive eating can occur in patients treated with dopamine agonists and/or other dopaminergic treatments such as Comtan in association with levodopa (see section 4.4).
Slovenian: Motnje pri obvladovanju impulzov: Pri bolnikih, ki se zdravijo z agonisti dopamina in/ali drugimi dopaminergičnimi zdravili, kot je zdravilo Comtan v povezavi z levodopo, lahko pride do patološkega hazardiranja, povečanega libida, hiperseksualnosti, kompulzivnega zapravljanja ali nakupovanja, prenajedanja ali kompulzivnega prenajedanja (glejte poglavje 4.4).
English: What Comtan looks like and contents of the pack Comtan 200 mg film-coated tablets are brownish-orange, oval tablets with “Comtan” engraved on one side.
Slovenian: Comtan 200 mg filmsko obložene tablete so rjavkastooranžne, ovalne tablete z vtisnjenim napisom “Comtan” na eni strani.
English: Comtan contains sucrose Comtan tablets contain a sugar called sucrose.
Slovenian: Tablete Comtan vsebujejo sladkor, ki ga imenujemo saharoza.
English: Patients and carers should be made aware that behavioural symptoms of impulse control disorders including pathological gambling, increased libido, hypersexuality, compulsive spending or buying, binge eating and compulsive eating can occur in patients treated with dopamine agonists and/or other dopaminergic treatments such as Comtan in association with levodopa.
Slovenian: Bolnike in njihove skrbnike je treba opozoriti, da pri bolnikih, ki se zdravijo z agonisti dopamina in/ali drugimi dopaminergičnimi zdravili, kot je zdravilo Comtan v povezavi z levodopo, lahko pride do vedenjskih simptomov, ki so znak motenj pri obvladovanju impulzov, kar vključuje patološko hazardiranje, povečan libido, hiperseksualnost, kompulzivno zapravljanje ali nakupovanje, prenajedanje in kompulzivno prenajedanje.
English: Comtan 200 mg film-coated tablets entacapone
Slovenian: Comtan 200 mg filmsko obložene tablete entakapon
English: Talk to your doctor or pharmacist before taking Comtan:
Slovenian: Pred začetkom jemanja zdravila Comtan se posvetujte z zdravnikom ali farmacevtom:
English: 1 tablet contains 200 mg of entacapone.
Slovenian: 1 tableta vsebuje 200 mg entakapona.
English: The maximum recommended dose is 10 tablets per day, i.e. 2,000 mg of Comtan.
Slovenian: Najvišji priporočeni odmerek je 10 tablet na dan, t.j.
English: maprotiline and venlafaxine, and medicinal products that are metabolised by COMT (e.g. catecholstructured compounds: rimiterol, isoprenaline, adrenaline, noradrenaline, dopamine, dobutamine, alpha-methyldopa, apomorphine, and paroxetine) is still limited.
Slovenian: Vendar so izkušnje s klinično uporabo entakapona z več zdravili, med drugim z zaviralci MAO-A, tricikličnimi antidepresivi, zaviralci ponovnega privzema noradrenalina, kot so desipramin, maprotilin in venlafaksin, in zdravili, ki jih presnavlja COMT (na primer spojine s kateholno skupino: rimiterol, izoprenalin, adrenalin, noradrenalin, dopamin, dobutamin, alfa-metildopa, apomorfin in paroksetin), še omejene.
English: Therefore, the use of Comtan in children or adolescents cannot be recommended.
Slovenian: Izkušenj z uporabo zdravila Comtan pri bolnikih, ki so stari manj kot 18 let, je malo, zato uporabe zdravila Comtan pri otrocih in mladostnikih ni mogoče priporočati.
English: How to store Comtan
Slovenian: Shranjevanje zdravila Comtan
English: Cardiac disorders** Common:
Slovenian: Srčne bolezni**
English: Marketing Authorisation Holder Orion Corporation Orionintie 1
Slovenian: Imetnik dovoljenja za promet z zdravilom Orion Corporation
English: Neuroleptic Malignant Syndrome (NMS) is a serious but rare reaction to certain medicines, and may occur especially when Comtan and other medicines to treat Parkinson's disease are suddenly stopped or the dose is suddenly reduced.
Slovenian: Do nje lahko pride zlasti pri nenadni prekinitvi zdravljenja z zdravilom Comtan in drugimi zdravili za zdravljenje Parkinsonove bolezni oziroma pri nenadnem znižanju odmerka teh zdravil.
English: Hepatitis with mainly cholestatic features (see section 4.4) Skin and subcutaneous tissue disorders Rare:
Slovenian: hepatitis s prevladujočimi znaki holestaze (glejte poglavje 4.4)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
Slovenian: Izgled zdravila Comtan in vsebina pakiranja
English: The dose of other medicines to treat Parkinson's disease may need to be adjusted when you start taking Comtan.
Slovenian: Morda bo ob uvedbi zdravila Comtan potrebno prilagoditi odmerke drugih zdravil za zdravljenje Parkinsonove bolezni.
English: General disorders and administration site conditions Common:
Slovenian: sprememba barve urina Splošne težave in spremembe na mestu aplikacije pogosti:
English: It can be used in patients of all ages.
Slovenian: Zdravilo se lahko uporablja pri bolnikih vseh starosti.
English: Alprolix eftrenonacog alfa
Slovenian: Alprolix eftrenonakog alfa
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) therefore decided that Alprolix'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 zato zaključil, da so koristi zdravila Alprolix večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
English: This is a summary of the European public assessment report (EPAR) for Alprolix.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Alprolix.
English: What measures are being taken to ensure the safe and effective use of Alprolix?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Alprolix?
English: A risk management plan has been developed to ensure that Alprolix is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila Alprolix je bil pripravljen načrt obvladovanja tveganj.