FrancophonIA/ELRC3.0 huggingface dataset:
English: • There is considerable evidence from large clinical trials such as ONTARGET1, ALTITUDE2 and VA NEPHRON-D3 and from meta-analyses such as that of Makani4 (involving over 68,000 patients) demonstrating that dual RAS blockade through the combined use of ACE-inhibitors, ARBs or aliskiren is associated with an increased risk of adverse events, including hypotension, hyperkalaemia and renal failure compared with monotherapy, in particular in patients with diabetic nephropathy.
Slovenian: • Obstaja veliko dokazov iz obsežnih kliničnih preskušanj, kot so ONTARGET1, ALTITUDE2 in VA NEPHRON-D3, in metaanaliz, kot je Makani4 (vključenih je bilo več kot 68 000 bolnikov), ki kažejo, da je zdravljenje z dvojnim zaviranjem renin-angiotenzinskega sistema s kombinirano uporabo zaviralcev ACE, zaviralcev angiotenzinskih receptorjev ali aliskirena povezano s povečanim tveganjem za neželene učinke, vključno s hipotenzijo, hiperkaliemijo in ledvično odpovedjo, v primerjavi z monoterapijo, zlasti pri bolnikih z diabetično nefropatijo.
English: ARBs (containing the active substances azilsartan, candesartan, eprosartan, irbesartan, losartan, olmesartan, telmisartan or valsartan) block receptors for a hormone called angiotensin II.
Slovenian: Zaviralci angiotenzinskih receptorjev (vsebujejo zdravilne učinkovine azilsartan, kandesartan, eprosartan, irbesartan, losartan, olmesartan, telmisartan ali valsartan) zavirajo receptorje za hormon, ki se imenuje angiotenzin II.
English: Furthermore, no significant benefits from dual blockade were seen in patients without heart failure and benefits were thought to outweigh risk only in a selected group of patients with heart failure in whom other treatments were unsuitable.
Slovenian: Nadalje zdravljenje z dvojnim zaviranjem ni pokazalo nobenih pomembnih koristi pri bolnikih brez srčnega popuščanja, zato naj bi bilo razmerje med tveganji in koristmi ugodno samo pri izbrani skupini bolnikov s srčnim popuščanjem, pri katerih ni mogoče uporabiti drugih vrst zdravljenja.
English: • Such supervised use would include the licensed use of candesartan or valsartan as add-on therapy to ACE inhibitors in patients with heart failure.
Slovenian: • Takšna nadzorovana uporaba bi vključevala licencirano uporabo kandesartana ali valsartana kot dodatno zdravljenje k zaviralcem ACE pri bolnikih s srčnim popuščanjem.
English: On 23 May 2014 the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) endorsed restrictions on combining different classes of medicines that act on the reninangiotensin system (RAS), a hormone system that controls blood pressure and the volume of fluids in the body.
Slovenian: 23. maja 2014 sprejel omejitve kombinirane uporabe zdravil različnih skupin, ki delujejo na reninangiotenzinski sistem, tj. hormonski sistem, ki uravnava krvni tlak in tekočinski volumen v telesu.
English: The product information for all RAS-acting agents has been amended accordingly.
Slovenian: Informacije o zdravilu za vse snovi, ki delujejo na renin-angiotenzinski sistem, so bile zato ustrezno spremenjene.
English: • The existing contraindication on the concomitant use of ACE-inhibitors or ARBs with aliskirencontaining products in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m2), which is based on the ALTITUDE study data, was confirmed in the light of the additional data reviewed.
Slovenian: • Obstoječe kontraindikacije glede sočasne uporabe zaviralcev ACE ali zaviralcev angiotenzinskih receptorjev z zdravili, ki vsebujejo aliskiren, pri bolnikih s sladkorno boleznijo ali ledvično okvaro (GFR < 60 ml/min/1,73 m2), ki temeljijo na podatkih iz študije ALTITUDE, so bile potrjene ob upoštevanju dodatnih pregledanih podatkov.
English: In patients with heart failure there is some evidence that the addition of a second RAS-acting agent may reduce hospital admissions.
Slovenian: Pri bolnikih s srčnim popuščanjem obstajajo dokazi, da lahko dodatek druge snovi, ki deluje na renin-angiotenzinski sistem, zmanjša število sprejemov v bolnišnico.
English: • On the basis of current evidence, dual RAS blockade therapy through the combined use of ACEinhibitors, ARBs or aliskiren is not recommended in any patient.
Slovenian: • Na podlagi trenutnih dokazov zdravljenje z dvojnim zaviranjem renin-angiotenzinskega sistema s kombinirano uporabo zaviralcev ACE, zaviralcev angiotenzinskih receptorjev ali aliskirena ni priporočeno pri nobenih bolnikih.
English: These studies found that combination of an ARB with an ACE-inhibitor was associated with an increased risk of hyperkalaemia (increased potassium in the blood), kidney damage or low blood pressure compared with using either medicine alone.
Slovenian: V teh študijah so ugotovili, da je kombinacija zaviralcev angiotenzinskih receptorjev z zaviralci ACE povezana s povečanim tveganjem za hiperkaliemijo (zvišano koncentracijo kalija v krvi), ledvično okvaro ali nizek krvni tlak v primerjavi z uporabo katerega koli od zdravil v monoterapiji.
English: • RAS-acting agents from two different classes have sometimes been combined for an increased effect.
Slovenian: • Občasno je bila uporabljena kombinacija snovi, ki delujejo na renin-angiotenzinski sistem, iz dveh različnih skupin, da bi se povečal njihov učinek.
English: • RAS-acting agents are medicines acting on a hormone system that helps to control blood pressure and the amount of fluid in the body.
Slovenian: • Snovi, ki delujejo na renin-angiotenzinski sistem, so zdravila, ki delujejo na hormonski sistem, ki pomaga uravnavati krvni tlak in količino tekočine v telesu.
English: RAS-acting agents work by blocking different stages of the renin-angiotensin system (RAS).
Slovenian: Snovi, ki delujejo na renin-angiotenzinski sistem, zavirajo različne faze renin-angiotenzinskega sistema.
English: This would include the licensed use of the ARBs candesartan or valsartan as addon therapy to ACE-inhibitors in patients with heart failure who require such a combination.
Slovenian: To bi vključevalo licencirano uporabo zaviralca angiotenzinskih receptorjev kandesartana ali valsartana kot dodatnega zdravljenja k zaviralcem ACE pri bolnikih s srčnim popuščanjem, pri katerih je takšna kombinacija potrebna.
English: These medicines (called RAS-acting agents) belong to three main classes: angiotensin-receptor blockers (ARBs, sometimes known as sartans), angiotensin-converting enzyme inhibitors (ACEinhibitors) and direct renin inhibitors such as aliskiren.
Slovenian: Ta zdravila (imenovana snovi, ki delujejo na renin-angiotenzinski sistem) spadajo v tri glavne skupine zdravil: zaviralci angiotenzinskih receptorjev (ARB-ji, ki jih imenujemo tudi sartani), zaviralci angiotenzin konvertirajočega encima (zaviralci ACE) in neposredni zaviralci renina, kot je aliskiren.
English: • In individual cases where combined use of an ARB and ACE inhibitor is considered absolutely essential, it must be carried out under specialist supervision with close monitoring of renal function, electrolytes and blood pressure.
Slovenian: • Če je pri posameznem primeru kombinirana uporaba zaviralcev angiotenzinskih receptorjev in zaviralcev ACE nujno potrebna, mora biti izvedena pod nadzorom zdravnika specialista ob skrbnem spremljanju delovanja ledvic, vrednosti elektrolitov in krvnega tlaka.
English: The combination of aliskiren with an ARB or ACE-inhibitor is strictly contraindicated in those with kidney impairment or diabetes.
Slovenian: Kombinacija aliskirena z zaviralci angiotenzinskih receptorjev ali zaviralci ACE je strogo kontraindicirana pri bolnikih z ledvično okvaro ali sladkorno boleznijo.
English: Where combination of these medicines (dual blockade) is considered absolutely necessary, it must be carried out under specialist supervision with close monitoring of kidney function, fluid and salt balance and blood pressure.
Slovenian: Če je kombinacija teh zdravil (zdravljenje z dvojnim zaviranjem) nujno potrebna, mora biti izvedena pod nadzorom zdravnika specialista ob skrbnem spremljanju delovanja ledvic, tekočinskega ravnovesja in ravnovesja soli ter krvnega tlaka.
English: • Combining RAS-acting agents is therefore no longer recommended.
Slovenian: • Kombiniranje snovi, ki delujejo na renin-angiotenzinski sistem, zato ni več priporočljivo.
English: In particular, ACE-inhibitors and ARBs should not be used concomitantly in patients with diabetic nephropathy, and existing contraindications on the use of aliskiren with either an ARB or an ACE inhibitor in patients with diabetes mellitus or moderate to severe renal impairment (GFR < 60 ml/min/1.73 m2) are confirmed.
Slovenian: Potrjene so tudi obstoječe kontraindikacije glede uporabe aliskirena z zaviralci angiotenzinskih receptorjev ali zaviralci ACE pri bolnikih s sladkorno boleznijo ali zmerno do hudo ledvično okvaro (GFR < 60 ml/min/1,73 m2).
English: When this is considered absolutely necessary, it will be carried out under specialist supervision with close monitoring of kidney function, fluid and salt balance and blood pressure.
Slovenian: Če je kombinacija teh zdravil nujno potrebna, mora biti izvedena pod nadzorom zdravnika specialista ob skrbnem spremljanju delovanja ledvic, tekočinskega ravnovesja in ravnovesja soli ter krvnega tlaka.
English: These medicines can be of three different classes known as ARBs, ACE inhibitors and direct renin inhibitors (the last represented by the medicine aliskiren).
Slovenian: Zdravila so lahko iz treh različnih skupin, tj. zaviralci angiotenzinskih receptorjev, zaviralci ACE in neposredni zaviralci renina, kot je na primer aliskiren.
English: In particular, patients who have kidney problems related to diabetes should not be given an ARB with an ACE inhibitor (use of either of these types of medicine with aliskiren is already prohibited in patients with diabetes or kidney problems).
Slovenian: Uporabi zaviralcev angiotenzinskih receptorjev skupaj z zaviralci ACE (uporaba katere koli od teh vrst zdravil skupaj z aliskirenom je že prepovedana pri bolnikih s sladkorno boleznijo ali ledvičnimi težavami) se je treba posebej izogibati pri bolnikih z ledvičnimi težavami, povezanimi s sladkorno boleznijo.
English: The CHMP opinion confirmed recommendations made by the Agency's Pharmacovigilance Risk Assessment Committee (PRAC) in April 2014, following assessment of evidence from several large studies in patients with various pre-existing heart and circulatory disorders, or with type 2 diabetes.
Slovenian: Po oceni dokazov iz več obsežnih študij pri bolnikih z različnimi predhodno obstoječimi srčnimi motnjami in motnjami krvnega obtoka ali s sladkorno boleznijo tipa 2 je odbor CHMP s svojim mnenjem potrdil priporočila Odbora za oceno tveganja na področju farmakovigilance (PRAC).
English: Shake vigorously at least 20 times before use.
Slovenian: Pred uporabo vsaj 20-krat krepko pretresite.
English: Approximately 98 % of meloxicam is bound to plasma proteins.
Slovenian: Porazdelitev Približno 98 % meloksikama se veže na beljakovine v plazmi.
English: When the product is used according to the recommended dosage regime the oral bioavailability is approximately 98 %.
Slovenian: Če se zdravilo daje po priporočeni shemi odmerjanja, je njegova peroralna biološka uporabnost približno 98 %.
English: The metabolism is qualitatively similar in rats, mini-pigs, humans, cattle and pigs although quantitatively there are differences.
Slovenian: Presnavljanje je kakovostno pri podganah, mini prašičih, ljudeh, govedu in prašičih podobno, količinsko pa se razlikuje.
English: All major metabolites have been shown to be pharmacologically inactive.
Slovenian: Vsi poglavitni presnovki so farmakološko neaktivni.
English: In case the product is mixed with food, it should be added to a small quantity of food, prior to feeding.
Slovenian: Če se zdravilo daje zamešano v hrano, ga je treba majhni količini hrane dodati pred hranjenjem.
English: The excipients listed in section 6.1 of the SPC are either allowed substances for which table 1 of annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or are considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this product.
Slovenian: Za pomožne snovi, navedene v poglavju 6.1 SPC, tabela 1 (dovoljene snovi) priloge Uredbe Komisije (EU) št.37/2010 določa, da MRL ni potreben ali pa, kot so uporabljene v tem zdravilu za uporabo v veterinarski medicini, niso vključene v Uredbo (ES) št. 470/2009.
English: Pregnancy and lactation: See section “Contraindications”.
Slovenian: Brejost in laktacija: Glejte poglavje Kontraindikacije.
English: Cardboard box containing one high density polyethylene (HDPE) bottle of 125 ml or 336 ml with a HDPE screw cap and a polypropylene measuring syringe.
Slovenian: Kartonska škatla vsebuje po eno plastenko iz polietilena visoke gostote (HDPE) po 125 ml ali 336 ml z navojno zaporko iz HDPE ter merilno brizgo iz polipropilena.
English: To be administered either mixed with a small quantity of food, prior to feeding, or directly into the mouth.
Slovenian: Zdravilo se daje zamešano v majhno količino hrane pred hranjenjem ali neposredno v gobec.
English: The active substance in Novaquin is an allowed substance as described in table 1 of the annex to Commission Regulation (EU) No 37/2010:
Slovenian: C. NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN OSTANKOV ZDRAVILA (MRL) Zdravilna učinkovina v zdravilu Novaquin je dovoljena učinkovina, kot je navedena v tabeli 1 (dovoljene snovi) priloge Uredbe Komisije (EU) št. 37/2010:
English: The major metabolites found in all species were the 5-hydroxyand 5-carboxy-metabolites and the oxalyl-metabolite.
Slovenian: Poglavitni presnovki, ki so jih odkrili pri vseh vrstah, so 5-hidroksi- in 5karboksi-presnovki ter oksalil-presnovek.
English: Do not use in horses suffering from gastrointestinal disorders such as irritation and haemorrhage, impaired hepatic, cardiac or renal function and haemorrhagic disorders.
Slovenian: Ne uporabite pri konjih z obolenji prebavil, kot so vzdraženost prebavil in krvavitve, pri motnjah delovanja jeter, srca ali ledvic in pri hemoragičnih obolenjih.
English: Dosage Oral suspension to be administered at a dosage of 0.6 mg/kg body weight, once daily, up to 14 days.
Slovenian: Odmerjanje Peroralna suspenzija, ki se jo daje v odmerkih po 0,6 mg/kg telesne mase, enkrat na dan, do 14 dni.
English: Do not use in case of hypersensitivity to the active substance or to any of the excipients.
Slovenian: Ne uporabite v primeru preobčutljivosti za zdravilno učinkovino ali katero koli pomožno snov.
English: To be administered either mixed with food or directly into the mouth at a dosage of 0.6 mg/kg body weight, once daily, up to 14 days.
Slovenian: Zdravilo se daje pomešano s hrano ali neposredno v gobec v odmerkih po 0,6 mg/kg telesne mase, enkrat na dan, do 14 dni.
English: Manufacturer responsible for batch release: Produlab Pharma B.V.
Slovenian: Izdelovalec, odgovoren za sproščanje serij Produlab Pharma B.V.
English: Suomi/Finland Dechra Veterinary Products Oy Stora Wäsby Orangeriet 3 194 37 Upplands Väsby Sweden
Slovenian: Dechra Veterinary Products Oy Stora Wäsby Orangeriet 3 194 37 Upplands Väsby Sweden
English: In very rare cases loss of appetite, lethargy, abdominal pain and colitis have been reported.
Slovenian: Zelo redko so poročali o izgubi teka, letargiji, bolečinah v trebuhu in kolitisu.
English: Overdose (symptoms, emergency procedures, antidotes): In case of overdose symptomatic treatment should be initiated.
Slovenian: Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi): Pri nenamernem vnosu prevelikega odmerka je treba uvesti simptomatsko zdravljenje.
English: Do not use after the expiry date stated on the carton and the bottle after EXP.
Slovenian: Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na zunanji ovojnini in plastenki za EXP.
English: Interaction with other medicinal products and other forms of interaction: Do not administer concurrently with glucocorticoids, other non-steroidal anti-inflammatory drugs or with anticoagulant agents.
Slovenian: Medsebojno delovanje z drugimi zdravili in druge oblike interakcij: Zdravilo se ne sme dajati hkrati z glukokortikoidi, drugimi nesteroidnimi protivnetnimi zdravili ali antikoagulansi.
English: Shelf-life after first opening of the container: 5 months.
Slovenian: Rok uporabnosti po prvem odpiranju vsebnika: 5 mesecev.
English: EXP {month/year} Shelf-life of opened bottle: 5 months.
Slovenian: EXP {mesec/leto} Rok uporabnosti odprte plastenke: 5 mesecev.
English: Not all pack sizes may be marketed.For any information about this veterinary medicinal product, please contact the local representative of the marketing authorisation holder.
Slovenian: Za vse nadaljnje informacije o tem zdravilu se obrnite na krajevno predstavništvo imetnika dovoljenja za promet z zdravilom.
English: Any unused medicines or waste materials should not be disposed of via wastewater or household waste but in accordance with local requirements.
Slovenian: Vsako neporabljeno zdravilo ali odpadne snovi je treba odstraniti v skladu z lokalnimi predpisi.
English: Yellowish-green viscous oral suspension.
Slovenian: Rumenkasto-zelena viskozna peroralna suspenzija
English: Hydroxyethylcellulose Silica, colloidal anhydrous Disodium phosphate dodecahydrate Citric acid monohydrate Sodium cyclamate Sorbitol, liquid
Slovenian: 6.1 Seznam pomožnih snovi natrijev benzoat glicerol polisorbat 80 hidroksietilceluloza silicijev dioksid, koloidni, brezvodni natrijev hidrogenfosfat dodekahidrat citronska kislina monohidrat natrijev ciklamat sorbitol, tekoči sukraloza aroma janeža prečiščena voda
English: 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
Slovenian: 4.10 Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi) (če je potrebno) Pri nenamernem vnosu prevelikega odmerka je treba uvesti simptomatsko zdravljenje.
English: Do not administer concurrently with glucocorticoids, other non-steroidal anti-inflammatory drugs or with anticoagulant agents.
Slovenian: Zdravilo se ne sme dajati hkrati z glukokortikoidi, drugimi nesteroidnimi protivnetnimi zdravili ali antikoagulansi.
English: MINIMUM PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
English: EU/2/15/186/001-002
Slovenian: ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/15/186/001-002
English: Pharmacotherapeutic group: Antiinflammatory and antirheumatic products, non-steroids (oxicams).
Slovenian: Farmakoterapevtska skupina: protivnetna in protirevmatična zdravila, nesteroidna (oksikami) Oznaka ATCvet: QM01AC06.
English: HDPE-bottle
Slovenian: Plastenka HDPE
English: Novaquin 15 mg/ml oral suspension for horses
Slovenian: Novaquin 15 mg/ml peroralna suspenzija za konje
English: Marketing authorisation holder: Le Vet Pharma B.V.
Slovenian: Imetnik dovoljenja za promet z zdravilom Le Vet Beheer B.V.
English: Sodium benzoate
Slovenian: Pomožna snov: natrijev benzoat
English: Outer carton
Slovenian: Zunanja ovojnina
English: EXP (month/year) Once broached, use by ……….
Slovenian: EXP {mesec/leto} Po odprtju uporabiti do:
English: Isolated cases of adverse reactions typically associated with Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) were observed in clinical trials (slight urticaria, diarrhoea).
Slovenian: V kliničnih preskušanjih so zasledili posamezne primere neželenih učinkov, ki so značilni za nesteroidna protivnetna zdravila (NSAID) (blaga urtikarija, driska).
English: MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Slovenian: IZDELOVALEC, ODGOVOREN ZA SPROSTITEV SERIJE
English: MARKETING AUTHORISATION HOLDER
Slovenian: ŠTEVILKE DOVOLJENJ ZA PROMET
English: Novaquin 15 mg/ml oral suspension for horses Meloxicam
Slovenian: Novaquin 15 mg/ml peroralna suspenzija za konje meloksikam
English: Palackeho trida 163 a 61200 Brno Tel. +420 541 426 370
Slovenian: Slovenská republika Sevaron ltd Palackeho trida 163 a 61200 Brno Tel. +420 541 426 370
English: Novaquin 15 mg/ml oral suspension for horses meloxicam
Slovenian: Novaquin 15 mg/ml, peroralna suspenzija za konje meloksikam
English: People with known hypersensitivity to Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) should avoid contact with the veterinary medicinal product.
Slovenian: Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo Osebe z znano preobčutljivostjo za nesteroidna protivnetna zdravila (NSAID) naj se izogibajo stiku z zdravilom.
English: Active substance Meloxicam 15 mg.
Slovenian: Učinkovina: meloksikam 15 mg
English: 20 μg/kg 65 μg/kg 65 μg/kg
Slovenian: 20 µg/kg 65 µg/kg 65 µg/kg mišice jetra ledvice ni vnosa Protivnetna zdravila/nesteroidna protivnetna zdravila govedo, prašiči
English: A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJE B. POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM TER OMEJITVE GLEDE
English: People with known hypersensitivity to NSAIDs should avoid contact with the veterinary medicinal product.
Slovenian: Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo: Osebe z znano preobčutljivostjo za NSAID naj se izogibajo stiku z zdravilom.
English: Avoid use in any dehydrated, hypovolaemic or hypotensive animals as there is a potential risk of renal toxicity.
Slovenian: Posebni previdnostni ukrepi za uporabo pri živalih Zaradi nevarnosti toksičnih učinkov na ledvice se je treba dajanju zdravila izogibati pri dehidriranih, hipovolemičnih ali hipotenzivnih živalih.
English: Do not use in pregnant or lactating mares.
Slovenian: Ne uporabite pri kobilah v obdobju brejosti in laktacije.
English: Distribution
Slovenian: Presnavljanje
English: 2 July 2012
Slovenian: 2. julij 2012
English: 1 Revlimid is marketed in Austria, Belgium, Cyprus, the Czech Republic, Denmark, Finland, France, Germany, Greece Ireland, Italy, Luxembourg, Malta, the Netherlands, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden and the United Kingdom.
Slovenian: Zdravilo Revlimid se trži v Avstriji, Belgiji, na Cipru, na Češkem, na Danskem, na Finskem, v Franciji, v Nemčiji, v Grčiji, na Irskem, v Italiji, v Luksemburgu, na Malti, na Nizozemskem, na Poljskem, na Portugalskem, na Slovaškem, v Sloveniji, v Španiji, na Švedskem in v Združenem kraljestvu.
English: Revlimid has been authorised in the European Union (EU) since 14 June 2007 and is marketed in 21 EU Member States1.
Slovenian: Zdravilo Revlimid je bilo odobreno v Evropski uniji (EU) 14. junija 2007 in se trži v 21 državah članicah EU1.
English: The applicant presented data from two main studies involving 1073 patients with newly diagnosed multiple myeloma.
Slovenian: Predlagatelj je predložil podatke iz dveh glavnih študij, v katerih je sodelovalo 1 073 bolnikov z na novo diagnosticiranim multiplim mielomom.
English: Therefore, more mature survival data and follow-up would be needed to conclude on the benefit-risk balance for this indication.
Slovenian: Potrebnih je torej več podatkov o preživetju in spremljevalnih študij, da bi lahko sprejeli sklep o razmerju med tveganji in koristmi za to indikacijo.
English: After the CHMP had assessed the company's responses to the questions, there were still some unresolved issues.
Slovenian: Ko je CHMP ocenil odgovore družbe na zastavljena vprašanja, so nekatera izmed njih še vedno ostala nerešena.
English: The application was withdrawn after the CHMP had evaluated the documentation provided by the company and formulated lists of questions.
Slovenian: Vloge je bila umaknjena, potem ko je CHMP ocenil dokumentacijo, ki jo je predložila družba, in oblikoval sezname vprašanj.
English: Lenalidomide works in a number of different ways in multiple myeloma: it blocks the development of tumour cells, prevents the growth of blood vessels within tumours and also stimulates some of the specialised cells of the immune system to attack the cancerous cells.
Slovenian: Lenalidomid deluje na multipli mielom na številne načine: preprečuje razvoj tumorskih celic, preprečuje rast krvnih žil v tumorjih in spodbuja nekatere posebne celice imunskega sistema k napadanju rakastih celic.