natgillin/translations-raw huggingface dataset:
Copalia HCT 5 mg/160 mg/12.5 mg film-coated tablets Copalia HCT 10 mg/160 mg/12.5 mg film-coated tablets Copalia HCT 5 mg/160 mg/25 mg film-coated tablets Copalia HCT 10 mg/160 mg/25 mg film-coated tablets Copalia HCT 10 mg/320 mg/25 mg film-coated tablets 
Copalia HCT 5 mg/160 mg/12,5 mg filmsko obložene tablete Copalia HCT 10 mg/160 mg/12,5 mg filmsko obložene tablete Copalia HCT 5 mg/160 mg/25 mg filmsko obložene tablete Copalia HCT 10 mg/160 mg/25 mg filmsko obložene tablete Copalia HCT 10 mg/320 mg/25 mg filmsko obložene tablete
Excessive hypotension, including orthostatic hypotension, was seen in 1.7% of patients treated with the maximum dose of Copalia HCT (10 mg/320 mg/25 mg) compared to 1.8% of valsartan/hydrochlorothiazide (320 mg/25 mg) patients, 0.4% of amlodipine/valsartan (10 mg/320 mg) patients, and 0.2% of hydrochlorothiazide/amlodipine (25 mg/10 mg) patients in a controlled trial in patients with moderate to severe uncomplicated hypertension. 
V kontroliranem preskušanju pri bolnikih z zmerno do hudo nezapleteno hipertenzijo so čezmerno hipotenzijo, vključno z ortostatsko hipotenzijo, opažali pri 1,7 % bolnikov, ki so prejemali najvišji odmerek zdravila Copalia HCT (10 mg/320 mg/25 mg), v primerjavi z 1,8 % bolnikov, ki so prejemali valsartan/hidroklorotiazid (320 mg/25 mg), z 0,4 % bolnikov, ki so prejemali amlodipin/valsartan (10 mg/320 mg), in z 0,2 % bolnikov, ki so prejemali hidroklorotiazid/amlodipin (25 mg/10 mg).
Caution, including more frequent monitoring of blood pressure, is recommended in elderly patients, particularly at the maximum dose of Copalia HCT, 10 mg/320 mg/25 mg, since available data in this patient population are limited. 
Pri starejših bolnikih je priporočena previdnost, kar vključuje bolj pogosto merjenje krvnega tlaka, zlasti pri uporabi najvišjega odmerka zdravila Copalia HCT 10 mg/320 mg/25 mg, saj je za to skupino bolnikov na voljo le malo podatkov.
Caution is advised in patients with heart failure and coronary artery disease, particularly at the maximum dose of Copalia HCT, 10 mg/320 mg/25 mg, since available data in these patient populations is limited. 
Pri bolnikih s srčnim popuščanjem in koronarno boleznijo je priporočena previdnost, zlasti pri uporabi najvišjega odmerka zdravila Copalia HCT 10 mg/320 mg/25 mg, saj je pri teh skupinah bolnikov na voljo le malo podatkov.
Hypromellose, substitution type 2910 (3 mPa.s) Titanium dioxide (E171) Macrogol 4000 
Obloga hipromeloza, substitucijski tip 2910 (3 mPa.s) titanov dioksid (E171) makrogol 4000 smukec
Caution is advised in patients with heart failure and coronary artery disease, particularly at the maximum dose of Copalia HCT, 10 mg/320 mg/25 mg. 
Pri bolnikih s srčnim popuščanjem in koronarno boleznijo je priporočena previdnost, zlasti pri uporabi najvišjega odmerka zdravila Copalia HCT 10 mg/320 mg/25 mg.
Copalia HCT 5 mg/160 mg/12.5 mg film-coated tablets Copalia HCT 10 mg/160 mg/12.5 mg film-coated tablets Copalia HCT 5 mg/160 mg/25 mg film-coated tablets Copalia HCT 10 mg/160 mg/25 mg film-coated tablets Copalia HCT 10 mg/320 mg/25 mg film-coated tablets amlodipine/valsartan/hydrochlorothiazide 
Copalia HCT 5 mg/160 mg/12,5 mg filmsko obložene tablete Copalia HCT 10 mg/160 mg/12,5 mg filmsko obložene tablete Copalia HCT 5 mg/160 mg/25 mg filmsko obložene tablete Copalia HCT 10 mg/160 mg/25 mg filmsko obložene tablete Copalia HCT 10 mg/320 mg/25 mg filmsko obložene tablete amlodipin/valsartan/hidroklorotiazid
How to take Copalia HCT 
Kako jemati zdravilo Copalia HCT
You should never take Copalia HCT again. 
Ti bolniki ne smejo več prejemati zdravila Copalia HCT.
Grapefruit and grapefruit juice should not be consumed by people who are prescribed Copalia HCT. 
Zdravilo Copalia HCT skupaj s hrano, pijačo in alkoholom Ljudje, ki jim je zdravnik predpisal zdravilo Copalia HCT, ne smejo uživati grenivk in grenivkinega soka.
Copalia HCT 10 mg/320 mg/25 mg film-coated tablets 
Copalia HCT 10 mg/320 mg/25 mg filmsko obložene tablete
Protect your skin from sun exposure and UV rays while taking Copalia HCT. 
Med jemanjem zdravila Copalia HCT zaščitite kožo pred izpostavljenostjo soncu in UV-žarkom.
Copalia HCT should be discontinued immediately in patients who develop angioedema and should not be re-administered. 
Bolnikom, pri katerih pride do angioedema, je treba zdravilo Copalia HCT takoj ukiniti.
There is limited experience with the use of Copalia HCT, particulary at the maximum dose, in patients with heart failure and coronary artery disease. 
Pri bolnikih s srčnim popuščanjem in koronarno boleznijo je le malo izkušenj z uporabo zdravila Copalia HCT, zlasti z uporabo najvišjega odmerka.
SIA Novartis Baltics Eesti filiaal Tel: +372 66 30 810 
Novartis Hungária Kft. Tel: +372 66 30 810
What Copalia HCT contains 
Kaj vsebuje zdravilo Copalia HCT
No dose adjustment of Copalia HCT is required for patients with mild to moderate renal impairment (GFR ≥30 ml/min/1.73 m 
Pri bolnikih z blago do zmerno okvaro ledvic (GFR ≥30 ml/min/1,73 m 2) odmerka zdravila Copalia
Multipack: 280 (4 packs of 70x1) film-coated tablets. 
Skupno pakiranje: 280 (20 škatel po 14) filmsko obloženih tablet Skupno pakiranje: (4 škatle po 70x1) filmsko obloženih tablet
Copalia HCT 5 mg/160 mg/12.5 mg film-coated tablets 
Copalia HCT 5 mg/160 mg/12,5 mg filmsko obložene tablete
Hypromellose, substitution type 2910 (3 mPa.s) Macrogol 4000 
Obloga hipromeloza, substitucijski tip 2910 (3 mPa.s) makrogol 4000 smukec rumeni železov oksid (E172)
EU/1/09/575/043 280 film-coated tablets 
EU/1/09/575/043 280 filmsko obloženih tablet
EU/1/09/575/004 56 film-coated tablets 
EU/1/09/575/004 56 filmsko obloženih tablet
Copalia HCT 10 mg/320 mg/25 mg film-coated tablets are brown-yellow, oval tablets with “NVR” on one side and “VFL” on the other side. 
Copalia HCT 10 mg/320 mg/25 mg filmsko obložene tablete so rjavo rumene ovalne tablete z oznako “NVR” na eni strani in “VFL” na drugi.
Copalia HCT 5 mg/160 mg/25 mg film-coated tablets 
Copalia HCT 5 mg/160 mg/25 mg filmsko obložene tablete
Copalia HCT 10 mg/160 mg/12.5 mg film-coated tablets 
Copalia HCT 10 mg/160 mg/12,5 mg filmsko obložene tablete
Copalia HCT 10 mg/160 mg/25 mg film-coated tablets 
Copalia HCT 10 mg/160 mg/25 mg filmsko obložene tablete
EU/1/09/575/042 98 film-coated tablets 
EU/1/09/575/042 98 filmsko obloženih tablet
EU/1/09/575/031 280 film-coated tablets 
EU/1/09/575/031 280 filmsko obloženih tablet
Copalia HCT 5 mg/160 mg/25 mg film-coated tablets are yellow, oval tablets with “NVR” on one side and “VEL” on the other side. 
Copalia HCT 5 mg/160 mg/25 mg filmsko obložene tablete so rumene ovalne tablete z oznako “NVR” na eni strani in “VEL” na drugi.
Copalia HCT 10 mg/160 mg/12.5 mg film-coated tablets are pale yellow, oval tablets with “NVR” on one side and “VDL” on the other side. 
Copalia HCT 10 mg/160 mg/12,5 mg filmsko obložene tablete so bledo rumene ovalne tablete z oznako “NVR” na eni strani in “VDL” na drugi.
Copalia HCT 10 mg/320 mg/25 mg film-coated tablets amlodipine/valsartan/hydrochlorothiaziade 
Copalia HCT 10 mg/320 mg/25 mg filmsko obložene tablete amlodipin/valsartan/hidroklorotiazid
EU/1/09/575/007 280 film-coated tablets 
EU/1/09/575/007 280 filmsko obloženih tablet
Copalia HCT 10 mg/320 mg/25 mg film-coated tablets The active substances of Copalia HCT are amlodipine (as amlodipine besylate), valsartan and hydrochlorothiazide. 
Copalia HCT 10 mg/320 mg/25 mg filmsko obložene tablete Učinkovine v zdravilu Copalia HCT so amlodipin (v obliki amlodipinijevega besilata), valsartan in hidroklorotiazid.
EU/1/09/575/006 98 film-coated tablets 
EU/1/09/575/006 98 filmsko obloženih tablet
EU/1/09/575/001 14 film-coated tablets 
EU/1/09/575/001 14 filmsko obloženih tablet
EU/1/09/575/030 98 film-coated tablets 
EU/1/09/575/030 98 filmsko obloženih tablet
EU/1/09/575/041 90 film-coated tablets 
EU/1/09/575/041 90 filmsko obloženih tablet
EU/1/09/575/049 14 film-coated tablets 
EU/1/09/575/049 14 filmsko obloženih tablet
EU/1/09/575/019 280 film-coated tablets 
EU/1/09/575/019 280 filmsko obloženih tablet
EU/1/09/575/040 56 film-coated tablets 
EU/1/09/575/040 56 filmsko obloženih tablet
EU/1/09/575/055 280 film-coated tablets 
EU/1/09/575/055 280 filmsko obloženih tablet
EU/1/09/575/018 98 film-coated tablets 
EU/1/09/575/018 98 filmsko obloženih tablet
EU/1/09/575/016 56 film-coated tablets 
EU/1/09/575/016 56 filmsko obloženih tablet
EU/1/09/575/054 98 film-coated tablets 
EU/1/09/575/054 98 filmsko obloženih tablet
EU/1/09/575/052 56 film-coated tablets 
EU/1/09/575/052 56 filmsko obloženih tablet
EU/1/09/575/005 90 film-coated tablets 
EU/1/09/575/005 90 filmsko obloženih tablet
What Copalia HCT looks like and contents of the pack Copalia HCT 5 mg/160 mg/12.5 mg film-coated tablets are white, oval tablets with “NVR” on one side and “VCL” on the other side. 
Izgled zdravila Copalia HCT in vsebina pakiranja Copalia HCT 5 mg/160 mg/12,5 mg filmsko obložene tablete so bele ovalne tablete z oznako “NVR”
EU/1/09/575/026 28 film-coated tablets 
EU/1/09/575/026 28 filmsko obloženih tablet
EU/1/09/575/027 30 film-coated tablets 
EU/1/09/575/027 30 filmsko obloženih tablet
EU/1/09/575/029 90 film-coated tablets 
EU/1/09/575/029 90 filmsko obloženih tablet
EU/1/09/575/003 30 film-coated tablets 
EU/1/09/575/003 30 filmsko obloženih tablet
EU/1/09/575/025 14 film-coated tablets 
EU/1/09/575/025 14 filmsko obloženih tablet
EU/1/09/575/038 28 film-coated tablets 
EU/1/09/575/038 28 filmsko obloženih tablet
Copalia HCT is contraindicated in patients with severe renal impairment, anuria or undergoing dialysis (see section 4.3). 
Pri bolnikih s hudo okvaro ledvic, z anurijo in pri bolnikih na dializi je uporaba zdravila Copalia HCT kontraindicirana (glejte poglavje 4.3).
EU/1/09/575/053 90 film-coated tablets 
EU/1/09/575/053 90 filmsko obloženih tablet
EU/1/09/575/037 14 film-coated tablets 
EU/1/09/575/037 14 filmsko obloženih tablet
EU/1/09/575/051 30 film-coated tablets 
EU/1/09/575/051 30 filmsko obloženih tablet
EU/1/09/575/002 28 film-coated tablets 
EU/1/09/575/002 28 filmsko obloženih tablet
Copalia HCT 10 mg/160 mg/25 mg film-coated tablets are brown-yellow, oval tablets with “NVR” on one side and “VHL” on the other side. 
Copalia HCT 10 mg/160 mg/25 mg filmsko obložene tablete so rjavo rumene ovalne tablete z oznako “NVR” na eni strani in “VHL” na drugi.
EU/1/09/575/014 28 film-coated tablets 
EU/1/09/575/014 28 filmsko obloženih tablet
EU/1/09/575/017 90 film-coated tablets 
EU/1/09/575/017 90 filmsko obloženih tablet
EU/1/09/575/013 14 film-coated tablets 
EU/1/09/575/013 14 filmsko obloženih tablet
EU/1/09/575/039 30 film-coated tablets 
EU/1/09/575/039 30 filmsko obloženih tablet
Copalia HCT 5 mg/160 mg/25 mg film-coated tablets The active substances of Copalia HCT are amlodipine (as amlodipine besylate), valsartan and hydrochlorothiazide. 
Copalia HCT 5 mg/160 mg/25 mg filmsko obložene tablete Učinkovine v zdravilu Copalia HCT so amlodipin (v obliki amlodipinijevega besilata), valsartan in hidroklorotiazid.
EU/1/09/575/015 30 film-coated tablets 
EU/1/09/575/015 30 filmsko obloženih tablet
Copalia HCT 5 mg/160 mg/25 mg film-coated tablets amlodipine/valsartan/hydrochlorothiaziade 
Copalia HCT 5 mg/160 mg/25 mg filmsko obložene tablete amlodipin/valsartan/hidroklorotiazid
Talk to your doctor or pharmacist before taking Copalia HCT if you have a low level of potassium or magnesium in your blood (with or without symptoms such as muscle weakness, muscle spasms, abnormal heart rhythm). 
Če imate to bolezen, uporaba zdravila Copalia HCT za vas ni priporočena; če imate bolezen, ki se imenuje sistemski eritematozni lupus (ki ga kratko imenujemo tudi “lupus” ali s kratico “SLE”); če imate sladkorno bolezen (visoko raven sladkorja v krvi); če imate visoke ravni holesterola ali trigliceridov v krvi; če imate po izpostavljanju soncu kožne reakcije, npr izpuščaj;
Copalia HCT 5 mg/160 mg/12.5 mg film-coated tablets The active substances of Copalia HCT are amlodipine (as amlodipine besylate), valsartan and hydrochlorothiazide. 
Copalia HCT 5 mg/160 mg/12,5 mg filmsko obložene tablete Učinkovine v zdravilu Copalia HCT so amlodipin (v obliki amlodipinijevega besilata), valsartan in hidroklorotiazid.
Copalia HCT 10 mg/160 mg/12.5 mg film-coated tablets The active substances of Copalia HCT are amlodipine (as amlodipine besylate), valsartan and hydrochlorothiazide. 
Copalia HCT 10 mg/160 mg/12,5 mg filmsko obložene tablete Učinkovine v zdravilu Copalia HCT so amlodipin (v obliki amlodipinijevega besilata), valsartan in hidroklorotiazid.
EU/1/09/575/044 56 x 1 film-coated tablet (unit dose) EU/1/09/575/045 98 x 1 film-coated tablet (unit dose) EU/1/09/575/046 280 x 1 film-coated tablet (unit dose) 
EU/1/09/575/044 56 x 1 filmsko obložena tableta (za enkratni odmerek) EU/1/09/575/045 98 x 1 filmsko obložena tableta (za enkratni odmerek) EU/1/09/575/046 280 x 1 filmsko obložena tableta (za enkratni odmerek)
Copalia HCT 10 mg/160 mg/25 mg film-coated tablets amlodipine/valsartan/hydrochlorothiaziade 
Copalia HCT 10 mg/160 mg/25 mg filmsko obložene tablete amlodipin/valsartan/hidroklorotiazid
EU/1/09/575/032 56 x 1 film-coated tablet (unit dose) EU/1/09/575/033 98 x 1 film-coated tablet (unit dose) EU/1/09/575/034 280 x 1 film-coated tablet (unit dose) 
EU/1/09/575/032 56 x 1 filmsko obložena tableta (za enkratni odmerek) EU/1/09/575/033 98 x 1 filmsko obložena tableta (za enkratni odmerek) EU/1/09/575/034 280 x 1 filmsko obložena tableta (za enkratni odmerek)
Copalia HCT 10 mg/160 mg/25 mg film-coated tablets The active substances of Copalia HCT are amlodipine (as amlodipine besylate), valsartan and hydrochlorothiazide. 
Copalia HCT 10 mg/160 mg/25 mg filmsko obložene tablete Učinkovine v zdravilu Copalia HCT so amlodipin (v obliki amlodipinijevega besilata), valsartan in hidroklorotiazid.
EU/1/09/575/028 56 film-coated tablets 
EU/1/09/575/028 56 filmsko obloženih tablet
EU/1/09/575/050 28 film-coated tablets 
EU/1/09/575/050 28 filmsko obloženih tablet
Copalia HCT 5 mg/160 mg/12.5 mg film-coated tablets amlodipine/valsartan/hydrochlorothiaziade 
Copalia HCT 5 mg/160 mg/12,5 mg filmsko obložene tablete amlodipin/valsartan/hidroklorotiazid
EU/1/09/575/008 56 x 1 film-coated tablet (unit dose) EU/1/09/575/009 98 x 1 film-coated tablet (unit dose) EU/1/09/575/010 280 x 1 film-coated tablet (unit dose) 
EU/1/09/575/008 56 x 1 filmsko obložena tableta (za enkratni odmerek) EU/1/09/575/009 98 x 1 filmsko obložena tableta (za enkratni odmerek) EU/1/09/575/010 280 x 1 filmsko obložena tableta (za enkratni odmerek)
EU/1/09/575/056 56 x 1 film-coated tablet (unit dose) EU/1/09/575/057 98 x 1 film-coated tablet (unit dose) EU/1/09/575/058 280 x 1 film-coated tablet (unit dose) 
EU/1/09/575/056 56 x 1 filmsko obložena tableta (za enkratni odmerek) EU/1/09/575/057 98 x 1 filmsko obložena tableta (za enkratni odmerek) EU/1/09/575/058 280 x 1 filmsko obložena tableta (za enkratni odmerek)
Copalia HCT 10 mg/160 mg/12.5 mg film-coated tablets amlodipine/valsartan/hydrochlorothiaziade 
Copalia HCT 10 mg/160 mg/12,5 mg filmsko obložene tablete amlodipin/valsartan/hidroklorotiazid
EU/1/09/575/020 56 x 1 film-coated tablet (unit dose) EU/1/09/575/021 98 x 1 film-coated tablet (unit dose) EU/1/09/575/022 280 x 1 film-coated tablet (unit dose) 
EU/1/09/575/020 56 x 1 filmsko obložena tableta (za enkratni odmerek) EU/1/09/575/021 98 x 1 filmsko obložena tableta (za enkratni odmerek) EU/1/09/575/022 280 x 1 filmsko obložena tableta (za enkratni odmerek)
Each film-coated tablet contains 10 mg amlodipine (as amlodipine besylate), 160 mg valsartan, and 25 mg hydrochlorothiazide. 
Ena filmsko obložena tableta vsebuje 10 mg amlodipina (v obliki amlodipinijevega besilata), 160 mg valsartana in 25 mg hidroklorotiazida.
EU/1/09/575/036 280 film-coated tablets (multipack, 20 cartons of 14 tablets) EU/1/09/575/035 280 film-coated tablets (multipack, 4 cartons of 70 tablets) (unit dose) 
EU/1/09/575/036 280 filmsko obloženih tablet (skupno pakiranje, 20 škatel po 14 tablet) EU/1/09/575/035 280 filmsko obloženih tablet (skupno pakiranje, 4 škatle po 70 tablet) (za enkratni odmerek)
EU/1/09/575/060 280 film-coated tablets (multipack, 20 cartons of 14 tablets) EU/1/09/575/059 280 film-coated tablets (multipack, 4 cartons of 70 tablets) (unit dose) 
EU/1/09/575/060 280 filmsko obloženih tablet (skupno pakiranje, 20 škatel po 14 tablet) EU/1/09/575/059 280 filmsko obloženih tablet (skupno pakiranje, 4 škatle po 70 tablet) (za enkratni odmerek)
Each film-coated tablet contains 10 mg amlodipine (as amlodipine besylate),160 mg valsartan, and 12.5 mg hydrochlorothiazide. 
Ena filmsko obložena tableta vsebuje 10 mg amlodipina (v obliki amlodipinijevega besilata), 160 mg valsartana in 12,5 mg hidroklorotiazida.
EU/1/09/575/048 280 film-coated tablets (multipack, 20 cartons of 14 tablets) EU/1/09/575/047 280 film-coated tablets (multipack, 4 cartons of 70 tablets) (unit dose) 
EU/1/09/575/048 280 filmsko obloženih tablet (skupno pakiranje, 20 škatel po 14 tablet) EU/1/09/575/047 280 filmsko obloženih tablet (skupno pakiranje, 4 škatle po 70 tablet) (za enkratni odmerek)
EU/1/09/575/012 280 film-coated tablets (multipack, 20 cartons of 14 tablets) EU/1/09/575/011 280 film-coated tablets (multipack, 4 cartons of 70 tablets) (unit dose) 
EU/1/09/575/012 280 filmsko obloženih tablet (skupno pakiranje, 20 škatel po 14 tablet) EU/1/09/575/011 280 filmsko obloženih tablet (skupno pakiranje, 4 škatle po 70 tablet) (za enkratni odmerek)
EU/1/09/575/024 280 film-coated tablets (multipack, 20 cartons of 14 tablets) EU/1/09/575/023 280 film-coated tablets (multipack, 4 cartons of 70 tablets) (unit dose) 
EU/1/09/575/024 280 filmsko obloženih tablet (skupno pakiranje, 20 škatel po 14 tablet) EU/1/09/575/023 280 filmsko obloženih tablet (skupno pakiranje, 4 škatle po 70 tablet) (za enkratni odmerek)
Copalia HCT should be discontinued if hypercalcaemia develops during treatment. 
Če pride med zdravljenjem do razvoja hiperkalciemije, je treba uporabo zdravila Copalia HCT prekiniti.
It is available as capsules (150 mg). 
Na voljo je v obliki kapsul (150 mg).
The recommended dose is one capsule once a day. 
Priporočeni odmerek je ena kapsula enkrat na dan.
The European Commission granted a marketing authorisation valid throughout the European Union for Erivedge on 12 July 2013. 
Evropska komisija je dovoljenje za promet z zdravilom Erivedge, veljavno po vsej Evropski uniji, izdala 12. julija 2013.
Other information about Erivedge 
Druge informacije o zdravilu Erivedge
The full EPAR for Erivedge 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) za zdravilo Erivedge je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
What measures are being taken to ensure the safe and effective use of Erivedge? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Erivedge?
It also considered that the side effects were manageable. 
Menil je tudi, da so neželeni učinki obvladljivi.
Erivedge was not compared with another treatment. 
Zdravila Erivedge niso primerjali z nobenim drugim zdravljenjem.
The patients were given Erivedge until their disease got worse or they could no longer tolerate treatment or withdrew from the study. 
Bolniki so zdravilo Erivedge prejemali, dokler se bolezen ni poslabšala ali ga niso mogli več prenašati oziroma so se umaknili iz študije.
Around 33% (11 out of 33) of patients with metastatic disease and 48% (30 out of 63) of patients with locally advanced disease responded to treatment. 
Na zdravljenje se je odzvalo okoli 33 % (11 od 33) bolnikov z metastatskim rakom in 48 % (30 od 63) bolnikov z lokalno napredovalo boleznijo.
This is a summary of the European public assessment report (EPAR) for Erivedge. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Erivedge.
Erivedge was originally given ‘conditional approval' because there was more evidence to come about the medicine. 
Zdravilo Erivedge je prvotno pridobilo „pogojno dovoljenje za promet“, ker se pričakujejo dodatni dokazi o zdravilu.
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Erivedge's benefits are greater than its risks and recommended that it be approved for use in the EU. 
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da so koristi zdravila Erivedge večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
As the company has supplied the additional information necessary, the authorisation has been switched from conditional to full approval. 
Ker je družba predložila dodatne potrebne informacije, je bilo dovoljenje za promet iz pogojnega spremenjenega v običajnega.
What is Erivedge and what is it used for? 
Kaj je zdravilo Erivedge in za kaj se uporablja?
It is not intended to provide practical advice on how to use Erivedge. 
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
The main measure of effectiveness was the response to treatment, based on reduction by at least 30% in tumour size or disappearance of all signs of cancer (the objective response rate). 
Glavno merilo učinkovitosti je bil odziv na zdravljenje, in sicer najmanj 30-odstotno zmanjšanje tumorja ali popolno izginotje znakov raka (objektivni delež odziva).
What benefits of Erivedge have been shown in studies? 
Kakšne koristi je zdravilo Erivedge izkazalo v študijah?
Why is Erivedge approved? 
Zakaj je bilo zdravilo Erivedge odobreno?
Erivedge was studied in one main study involving 104 patients with either metastatic or locally advanced basal cell carcinoma. 
Zdravilo Erivedge so proučevali v eni glavni študiji pri 104 bolnikih z metastatskim ali lokalno napredovalim bazalnoceličnim karcinomom.
The Committee considered that the benefits of Erivedge had been shown for patients with locally advanced and metastatic disease. 
Odbor je zaključil, da so bile koristi zdravila Erivedge dokazane za bolnike z lokalno napredovalo in metastatsko boleznijo.
It is used to treat adults with basal cell carcinoma (a slow-growing form of skin cancer) in advanced stages: when the cancer is metastatic (has spread to other parts of the body) and is causing symptoms, or when it is locally advanced (has started to spread to nearby areas) and is not suitable for surgery or radiotherapy (treatment with radiation). 
Uporablja se pri odraslih z bazalnoceličnim karcinomom (obliko počasi rastočega kožnega raka) v napredovalem stadiju: kadar je rak metastatski (se je razširil na druge dele telesa) in povzroča simptome ali kadar je napredoval lokalno (se je začel širiti na okoliška tkiva) in ni primeren za kirurški poseg ali radioterapijo.
The most common side effects with Erivedge (seen in more than 3 in 10 people) are muscle spasms, hair loss, taste disturbances, weight loss, tiredness, nausea (feeling sick) and diarrhoea. 
Najpogostejši neželeni učinki zdravila Erivedge (opaženi pri več kot 3 bolnikih od 10) so mišični krči, izpadanje las, motnje okušanja, zmanjšanje telesne mase, utrujenost, navzeja (slabost) in driska.
The company will report any pregnancies that occur during treatment with Erivedge and will monitor their outcome. 
Družba bo poročala o primerih nosečnosti med zdravljenjem z zdravilom Erivedge in spremljala posledice.
Erivedge is a cancer medicine that contains the active substance vismodegib. 
Erivedge je zdravilo za zdravljenje raka, ki vsebuje zdravilno učinkovino vismodegib.
The company will implement a pregnancy prevention programme, by providing educational materials on the risks to the unborn baby, including a reminder card, to patients and healthcare professionals who prescribe and dispense Erivedge. 
Družba bo vzpostavila program za preprečevanje nosečnosti in zagotovila izobraževalno gradivo o tveganjih za nerojenega otroka skupaj z opozorilno kartico za bolnike in zdravstvene delavce, ki bodo predpisovali in dajali zdravilo Erivedge.