natgillin/translations-raw huggingface dataset:
Non-psychiatric Cohort N=3984 Varenicline Bupropion 
nepsihiatrična kohorta n = 3.984 vareniklin bupropion NRT placebo število zdravljenih bolnikov AE sestavljenega glavnega opazovanega dogodka NPS, n (%)
Blood pressure increased, hot flush Respiratory, thoracic and mediastinal disorders 
• zvišan krvni tlak, vročinski oblivi
Treatment initiation pack containing 2 blisters; 1 clear blister of 11 x CHAMPIX 0.5 mg film-coated tablets and 1 clear blister of 14 x CHAMPIX 1 mg film-coated tablets in a carton. 
- Pakiranje za začetek zdravljenja, ki vsebuje 2 pretisna omota; 1 prozoren pretisni omot z 11 filmsko obloženimi tabletami CHAMPIX 0,5 mg in 1 prozoren pretisni omot s 14 filmsko obloženimi tabletami CHAMPIX 1 mg v škatli.
Treatment initiation pack containing 2 blisters; 1 clear blister of 11 x CHAMPIX 0.5 mg film-coated tablets and 1 clear blister of 14 x CHAMPIX 1 mg film-coated tablets in card packaging. 
- Pakiranje za začetek zdravljenja, ki vsebuje 2 pretisna omota; 1 prozoren pretisni omot z 11 filmsko obloženimi tabletami CHAMPIX 0,5 mg in 1 prozoren pretisni omot s 14 filmsko obloženimi tabletami CHAMPIX 1 mg, ki sta zavarjena v kartonskem pakiranju.
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister pack of 14 x 0.5 mg and 28 x 0.5 mg varenicline film-coated tablets, heat sealed card 
Pretisni omot s 14 in 28 filmsko obloženimi tabletami po 0,5 mg vareniklina v toplotno zavarjenem pakiranju
PVC blisters with aluminium foil backing in a pack containing 112 x 1 mg film-coated tablets in a carton. 
Pretisni omoti iz PVC z aluminijasto prekrivno folijo v pakiranju s 112 filmsko obloženimi tabletami po 1 mg v škatli.
2.99 (2.33, 3.83), P<0.0001 
s placebom 2,99 (2,33; 3,83), p < 0,0001 2,50 (1,90; 3,29), p < 0,0001 bupropion v prim.
In this 52-week duration study, patients received treatment for 12 weeks, followed by a 40-week non-treatment follow-up phase. 
V tej 52 tednov trajajoči študiji so bolniki zdravilo prejemali 12 tednov, temu pa je sledilo 40 tednov dolgo obdobje spremljanja, med katerim bolniki zdravila niso prejemali.
PVC blisters with aluminium foil backing containing one clear blister of 11 x 0.5 mg and 14 x 1 mg film-coated tablets and 1 clear blister of 28 or 2 clear blisters of 14 x 1 mg film-coated tablets in one secondary heat sealed card pack and PVC blisters with aluminium foil backing in two secondary heat sealed card packs each containing 56 x 1 mg film-coated tablets. 
pretisne omote iz PVC z aluminijasto prekrivno folijo v sekundarnem, toplotno zavarjenem pakiranju, ki vsebuje en prozoren pretisni omot z 11 filmsko obloženimi tabletami po 0,5 mg ter 14 filmsko obloženimi tabletami po 1 mg in 1 prozoren pretisni omot z 28 ali 2 prozorna pretisna omota s 14 filmsko obloženimi tabletami po 1 mg, ter pretisne omote iz PVC z aluminijasto prekrivno folijo v dveh sekundarnih, toplotno zavarjenih pakiranjih, od katerih vsako vsebuje 56 filmsko obloženih tablet po 1 mg.
Treatment initiation pack containing 2 blisters; 1 clear blister of 11 x CHAMPIX 0.5 mg and 14 x 1 mg film-coated tablets and 1 clear blister of 28 or 2 clear blisters of 14 x CHAMPIX 1 mg film-coated tablets in card packaging. 
- Pakiranje za začetek zdravljenja, ki vsebuje 2 pretisna omota; 1 prozoren pretisni omot z 11 filmsko obloženimi tabletami CHAMPIX 0,5 mg ter 14 filmsko obloženimi tabletami CHAMPIX 1 mg in 1 prozoren pretisni omot z 28 ali 2 prozorna pretisna omota s 14 filmsko obloženimi tabletami CHAMPIX 1 mg, ki sta zavarjena v kartonskem pakiranju.
PCTFE/PVC blisters with aluminium foil backing in a pack containing 112 x 1 mg film-coated tablets in a carton. 
Pretisni omoti iz PCTFE/PVC z aluminijasto prekrivno folijo v pakiranju s 112 filmsko obloženimi tabletami po 1 mg v škatli.
PVC blisters with aluminium foil backing in a pack containing 140 x 1 mg film-coated tablets in a carton. 
Pretisni omoti iz PVC z aluminijasto prekrivno folijo v pakiranju s 140 filmsko obloženimi tabletami po 1 mg v škatli.
PCTFE/PVC blisters with aluminium foil backing in a pack containing 28 x 0.5 mg film-coated tablets in secondary heat sealed card packaging. 
Pretisni omoti iz PCTFE/PVC z aluminijasto prekrivno folijo v sekundarnem, toplotno zavarjenem pakiranju z 28 filmsko obloženimi tabletami po 0,5 mg.
Heat sealed card pack containing either 2 or 4 blister packs of 14 x 1 mg varenicline film-coated tablets or 2 blister packs of 28 x 1 mg varenicline film-coated tablets- inner and outer labelling 
Toplotno zavarjeno pakiranje, ki vsebuje bodisi 2 ali 4 pretisne omote s po 14 filmsko obloženimi tabletami po 1 mg vareniklina bodisi 2 pretisna omota s po 28 filmsko obloženimi tabletami po 1 mg vareniklina - notranje in zunanje označevanje
Fungal infection, viral infection Blood and lymphatic system disorders Rare 
Redki glikozurija, poliurija Motnje reprodukcije in dojk Občasni menoragija
PVC blisters with aluminium foil backing in a pack containing 28 x 0.5 mg film-coated tablets in secondary heat sealed card packaging. 
Pretisni omoti iz PVC z aluminijasto prekrivno folijo v sekundarnem, toplotno zavarjenem pakiranju z 28 filmsko obloženimi tabletami po 0,5 mg.
Scotoma, scleral discolouration, mydriasis, photophobia, myopia, lacrimation increased 
Redki skotom, obarvanje beločnice, midriaza, fotofobija, miopija, močnejše solzenje Ušesne bolezni, vključno z motnjami labirinta Občasni tinitus
PCTFE/PVC blisters with aluminium foil backing in a pack containing 140 x 1 mg film-coated tablets in a carton. 
Pretisni omoti iz PCTFE/PVC z aluminijasto prekrivno folijo v pakiranju s 140 filmsko obloženimi tabletami po 1 mg v škatli.
PCTFE/PVC blisters with aluminium foil backing in a pack containing 56 x 0.5 mg film-coated tablets in secondary heat sealed card packaging. 
Pretisni omoti iz PCTFE/PVC z aluminijasto prekrivno folijo v sekundarnem, toplotno zavarjenem pakiranju s 56 filmsko obloženimi tabletami po 0,5 mg.
PVC blisters with aluminium foil backing in a pack containing 56 x 1 mg film-coated tablets in a carton. 
Pretisni omoti iz PVC z aluminijasto prekrivno folijo v pakiranju s 56 filmsko obloženimi tabletami po 1 mg v škatli.
Severe cutaneous reactions, including Stevens Johnson Syndrome and 
Poročali so tudi o primerih hudih kožnih reakcij, vključno z multiformnim eritemom (vrsta izpuščaja) in Stevens-Johnsonovim sindromom
Heat sealed card pack containing 2 blister packs of 28 or 4 blister packs of 14 x 1 mg varenicline film-coated tablets- inner and outer labelling 
Toplotno zavarjeno pakiranje, ki vsebuje 2 pretisna omota z 28 ali 4 pretisne omote s 14 filmsko obloženimi tabletami po 1 mg vareniklina - notranje in zunanje označevanje
PARTICULARS TO APPEAR ON THE OUTER PACKAGING High-density polyethylene (HDPE) bottle packaging for 56 x 0.5 mg varenicline film-coated tablets 
Nalepka za plastenko iz polietilena velike gostote (HDPE) s 56 filmsko obloženimi tabletami po 0,5 mg vareniklina
PVC blisters with aluminium foil backing in a pack containing 56 x 0.5 mg film-coated tablets in secondary heat sealed card packaging. 
Pretisni omoti iz PVC z aluminijasto prekrivno folijo v sekundarnem, toplotno zavarjenem pakiranju s 56 filmsko obloženimi tabletami po 0,5 mg.
Sealed white HDPE bottle pack, with a child resistant screw cap, in a carton, containing 56 x CHAMPIX 1 mg film-coated tablets. 
- Pakiranje z zapečateno belo plastenko iz HDPE z zaporko, varno za otroke, v škatli, ki vsebuje 56 filmsko obloženih tablet CHAMPIX 1 mg. - Pakiranje z zapečateno belo plastenko iz HDPE z zaporko, varno za otroke, v škatli, ki vsebuje 56 filmsko obloženih tablet CHAMPIX 0,5 mg.
Continuous Abstinence Rates in Subjects Treated with Champix versus Placebo 
Stopnje trajne abstinence pri preskušancih, zdravljenih z zdravilom Champix ali placebom CHAMPIX n = 249
Heat sealed card pack containing 1 blister pack of 11 x 0.5 mg and 14 x 1 mg varenicline film-coated tablets and 1 blister pack of 28 or 2 blister packs of 14 x 1 mg varenicline film-coated tablets - inner and outer labelling. 
Toplotno zavarjeno pakiranje, ki vsebuje 1 pretisni omot z 11 filmsko obloženimi tabletami po 0,5 mg vareniklina ter 14 filmsko obloženimi tabletami po 1 mg vareniklina in 1 pretisni omot z 28 ali 2 pretisna omota s 14 filmsko obloženimi tabletami po 1 mg vareniklina - notranje in zunanje označevanje.
PCTFE/PVC blisters with aluminium foil backing in a pack containing 56 x 1 mg film-coated tablets in a carton. 
Pretisni omoti iz PCTFE/PVC z aluminijasto prekrivno folijo v pakiranju s 56 filmsko obloženimi tabletami po 1 mg v škatli.
Seizures 
Odmerek
PVC blisters with aluminium foil backing in a pack containing 28 x 1 mg film-coated tablets in a carton. 
Pretisni omoti iz PVC z aluminijasto prekrivno folijo v pakiranju z 28 filmsko obloženimi tabletami po 1 mg v škatli.
PCTFE/PVC blisters with aluminium foil backing in a pack containing 28 x 1 mg film-coated tablets in secondary heat sealed card packaging. 
Pretisni omoti iz PCTFE/PVC z aluminijasto prekrivno folijo v sekundarnem, toplotno zavarjenem pakiranju z 28 filmsko obloženimi tabletami po 1 mg.
PCTFE/PVC blisters with aluminium foil backing in a pack containing 28 x 1 mg film-coated tablets in a carton. 
Pretisni omoti iz PCTFE/PVC z aluminijasto prekrivno folijo v pakiranju z 28 filmsko obloženimi tabletami po 1 mg v škatli.
Get emergency medical help right away if you have symptoms of a heart attack or stroke. 
Ob znakih srčnega infarkta ali možganske kapi takoj poiščite nujno zdravniško pomoč.
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS One blister pack of 28 or 2 blister packs of 14 x 1 mg varenicline film-coated tablets, heat sealed card 
En pretisni omot z 28 ali 2 pretisna omota s 14 filmsko obloženimi tabletami po 1 mg vareniklina v toplotno zavarjenem pakiranju
PVC blisters with aluminium foil backing in a pack containing 28 x 1 mg film-coated tablets in secondary heat sealed card packaging. 
Pretisni omoti iz PVC z aluminijasto prekrivno folijo v sekundarnem, toplotno zavarjenem pakiranju z 28 filmsko obloženimi tabletami po 1 mg.
PCTFE/PVC blisters with aluminium foil backing containing 1 clear blister of 11 x 0.5 mg film-coated tablets and a second clear blister containing 14 x 1 mg film-coated tablets in a carton. 
Pretisni omoti iz PCTFE/PVC z aluminijasto prekrivno folijo v pakiranju, ki vsebuje 1 prozoren pretisni omot z 11 filmsko obloženimi tabletami po 0,5 mg in drug prozoren pretisni omot s 14 filmsko obloženimi tabletami po 1 mg v škatli.
Varenicline vs Bupropion 1.49 (1.20, 1.85), P=0.0003 
z bupropionom 1,49 (1,20; 1,85), p = 0,0003 1,41 (1,11; 1,79), p = 0,0047 vareniklin v prim.
PCTFE/PVC blisters with aluminium foil backing in a pack containing 56 x 1 mg film-coated tablets in secondary heat sealed card packaging. 
Pretisni omoti iz PCTFE/PVC z aluminijasto prekrivno folijo v sekundarnem, toplotno zavarjenem pakiranju s 56 filmsko obloženimi tabletami po 1 mg.
PVC blisters with aluminium foil backing in a pack containing 56 x 1 mg film-coated tablets in secondary heat sealed card packaging. 
Pretisni omoti iz PVC z aluminijasto prekrivno folijo v sekundarnem, toplotno zavarjenem pakiranju s 56 filmsko obloženimi tabletami po 1 mg.
Tabulated summary of adverse reactions 
Preglednica neželenih učinkov
No dosage adjustment is recommended based on concomitant cimetidine administration in subjects with normal renal function or in patients with mild to moderate renal impairment. 
Pri osebah z normalnim delovanjem ledvic in pri bolnikih z blago do zmerno okvaro ledvic med sočasno uporabo cimetidina ni treba prilagoditi odmerka.
2.30 (1.83, 2.90), P<0.0001 
s placebom2,30 (1,83; 2,90), p < 0,0001 2,00 (1,56; 2,55), p < 0,0001 vareniklin v prim.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each 0.5 mg film-coated tablet contains 0.5 mg of varenicline (as tartrate). 
Ena 0,5 mg filmsko obložena tableta vsebuje 0,5 mg vareniklina (v obliki vareniklinijevega tartrata).
PVC blisters with aluminium foil backing containing 1 clear blister of 11 x 0.5 mg film-coated tablets and a second clear blister containing 14 x 1 mg film-coated tablets in a carton. 
Pretisni omoti iz PVC z aluminijasto prekrivno folijo v pakiranju, ki vsebuje 1 prozoren pretisni omot z 11 filmsko obloženimi tabletami po 0,5 mg in drug prozoren pretisni omot s 14 filmsko obloženimi tabletami po 1 mg v škatli.
EU/1/06/360/003 EU/1/06/360/008 EU/1/06/360/012 EU/1/06/360/014 EU/1/06/360/019 EU/1/06/360/023 EU/1/06/360/025 EU/1/06/360/026 
EU/1/06/360/014 EU/1/06/360/019 EU/1/06/360/023 EU/1/06/360/025 EU/1/06/360/026
hoarseness, hay fever, throat irritation, congested sinuses, excess mucous from nose causing cough, runny nose o Red blood in stools, irritated stomach, change of bowel habit, belching, mouth ulcers, 
• rdeča kri v blatu, razdražen želodec, spremembe pri navadah izločanja blata, riganje,
Haematochezia, gastritis, change of bowel habit, eructation, aphthous stomatitis, gingival pain Haematemesis, abnormal faeces, tongue coated Skin and subcutaneous tissue disorders Common Uncommon 
Občasni hematohezija, gastritis, spremembe navade v zvezi z odvajanjem blata, spahovanje, aftozni stomatitis, bolečine v dlesnih
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister pack of 11 x 0.5 mg varenicline film-coated tablets, heat sealed card 
Pretisni omot z 11 filmsko obloženimi tabletami po 0,5 mg vareniklina v toplotno zavarjenem pakiranju
3.24 (2.56, 4.11), P<0.0001 
s placebom 4,00 (3,20; 5,00), p < 0,0001 3,24 (2,56; 4,11), p < 0,0001 bupropion v prim.
Completed suicide b 
• samomorilne misli
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister pack of 14 x 1 mg and 28 x 1 mg varenicline film-coated tablets, heat sealed card 
Pretisni omot s 14 in 28 filmsko obloženimi tabletami po 1 mg vareniklina v toplotno zavarjenem pakiranju
Heat sealed card pack containing 1 blister pack of 11 x 0.5 mg varenicline film-coated tablets and 1 blister pack of 14 x 1 mg varenicline film-coated tablets - inner and outer labelling 
Dvotedensko začetno pakiranje (začetek zdravljenja) Toplotno zavarjeno pakiranje, ki vsebuje 1 pretisni omot z 11 filmsko obloženimi tabletami po 0,5 mg vareniklina in 1 pretisni omot s 14 filmsko obloženimi tabletami po 1 mg vareniklina - notranje in zunanje označevanje
Uncommon: may affect up to 1 in 100 people o Fungal infection, viral infection o Feeling of panic, difficulty thinking, restlessness, mood swings, depression, anxiety, 
• občutek panike, težave pri razmišljanju, nemir, nihanje razpoloženja, depresija, tesnoba,
2.26 (1.80, 2.85), P<0.0001 
s placebom 2,26 (1,80; 2,85), p < 0,0001 1,87 (1,46; 2,39), p < 0,0001 NRT v prim.
In addition, the table shows the subset of the composite NPS AE endpoint of severe intensity: Non-psychiatric Cohort N=3984 Varenicline Bupropion 
Poleg tega preglednica prikazuje tudi podskupino hudih neželenih dogodkov (AE - Adverse Event) sestavljenega opazovanega dogodka NPS:
Risk Ratio 
bolnikov-let izpostavljenosti razmerje tveganja
PCTFE/PVC blisters with aluminium foil backing containing 1 clear blister of 11 x 0.5 mg film-coated tablets and a second clear blister of 14 x 1 mg film-coated tablets in secondary heat sealed card packaging. 
Pretisni omoti iz PCTFE/PVC z aluminijasto prekrivno folijo v sekundarnem, toplotno zavarjenem pakiranju, ki vsebuje 1 prozoren pretisni omot z 11 filmsko obloženimi tabletami po 0,5 mg in drug prozoren pretisni omot s 14 filmsko obloženimi tabletami po 1 mg.
Heat sealed card pack containing 1 blister pack of 11 x 0.5 mg and 14 x 1 mg varenicline film-coated tablets and 1 blister pack of 28 or 2 blister packs of 14 x 1 mg varenicline film-coated tablets - inner and outer labelling 
Štiritedensko začetno pakiranje (začetek zdravljenja) Toplotno zavarjeno pakiranje, ki vsebuje 1 pretisni omot z 11 filmsko obloženimi tabletami po 0,5 mg vareniklina ter 14 filmsko obloženimi tabletami po 1 mg vareniklina in 1 pretisni omot z 28 ali 2 pretisna omota s 14 filmsko obloženimi tabletami po 1 mg vareniklina - notranje in zunanje označevanje
PARTICULARS TO APPEAR ON THE OUTER PACKAGING High-density polyethylene (HDPE) bottle packaging for 56 x 1 mg varenicline film-coated tablets 
Nalepka za plastenko iz polietilena velike gostote (HDPE) s 56 filmsko obloženimi tabletami po 1 mg vareniklina
Very common Abnormal dreams, insomnia Uncommon 
Redki sladkorna bolezen, polidipsija Psihiatrične motnje Zelo pogosti nenormalne sanje, nespečnost
UNIQUE IDENTIFIER - HUMAN READABLE DATA Not Applicable 
EDINSTVENA OZNAKA - V BERLJIVI OBLIKI
indigestion, flatulence, dry mouth o Skin rash, itching o Joint ache, muscle ache, back pain o Chest pain, tiredness 
• vnetje v nosu, sinusih in žrelu, zamašen nos, žrelo in prsni koš, hripavost, seneni nahod,
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister pack of 11 x 0.5 mg varenicline film-coated tablets 
Pretisni omot z 11 filmsko obloženimi tabletami po 0,5 mg vareniklina
PVC blisters with aluminium foil backing containing 1 clear blister of 11 x 0.5 mg and 14 x 1 mg film-coated tablets and 1 clear blister of 28 or 2 clear blisters of 14 x 1 mg film-coated tablets in secondary heat sealed card packaging. 
Pretisni omoti iz PVC z aluminijasto prekrivno folijo v sekundarnem, toplotno zavarjenem pakiranju, ki vsebuje 1 prozoren pretisni omot z 11 filmsko obloženimi tabletami po 0,5 mg ter 14 filmsko obloženimi tabletami po 1 mg in 1 prozoren pretisni omot z 28 ali 2 prozorna pretisna omota s 14 filmsko obloženimi tabletami po 1 mg.
PVC blisters with aluminium foil backing containing 1 clear blister of 11 x 0.5 mg film-coated tablets and a second clear blister of 14 x 1 mg film-coated tablets in secondary heat sealed card packaging. 
Pretisni omoti iz PVC z aluminijasto prekrivno folijo v sekundarnem, toplotno zavarjenem pakiranju, ki vsebuje 1 prozoren pretisni omot z 11 filmsko obloženimi tabletami po 0,5 mg in drug prozoren pretisni omot s 14 filmsko obloženimi tabletami po 1 mg.
Do not use if box has been opened. 
Če so vidni znaki odprtja, zdravila ne smete uporabiti.
2.00 (1.54, 2.59), P<0.0001 
s placebom 2,00 (1,54; 2,59), p < 0,0001 1,77 (1,33; 2,36), p < 0,0001 NRT v prim.
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister pack of 11 x 0.5 mg and 14 x 1 mg varenicline film-coated tablets, heat sealed card 
Pretisni omot z 11 filmsko obloženimi tabletami po 0,5 mg vareniklina ter 14 filmsko obloženimi tabletami po 1 mg vareniklina v toplotno zavarjenem pakiranju
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister pack of 14 x 1 mg varenicline film-coated tablets, heat sealed card 
Pretisni omot s 14 filmsko obloženimi tabletami po 1 mg vareniklina v toplotno zavarjenem pakiranju
Rare: may affect up to 1 in 1,000 people o Excessive thirst o Feeling unwell or unhappy, slow thinking o Stroke o Increased muscle tension, difficulty with speech, difficulty with coordination, reduced sense of taste, altered sleep pattern o Disturbed vision, eyeball discolouration, dilated pupils, sensitivity to light, 
• povečana mišična napetost, težave pri govoru, težave s koordinacijo, zmanjšana sposobnost okušanja, spremenjen vzorec spanja
It also considered that the side effects were manageable. 
Prav tako je menil, da so neželeni učinki obvladljivi.
What measures are being taken to ensure the safe and effective use of Odomzo? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Odomzo?
The most common side effects with Odomzo (which may affect more than 1 in 10 people) are muscle spasms, hair loss, taste disturbance, tiredness, nausea, vomiting, muscle and bone pain, belly ache, headache, diarrhoea, weight loss, loss of appetite, and itching. 
Najpogostejši neželeni učinki zdravila Odomzo (ki lahko prizadenejo več kot 1 osebo od 10) so mišični krči, izguba las, motnje okusa, utrujenost, navzeja (slabost), bruhanje, bolečina v mišicah ter kosteh, bolečina v trebuhu, glavobol, driska, izguba telesne mase, izguba teka in srbenje.
The full EPAR and risk management plan summary for Odomzo can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
Celotno evropsko javno poročilo o oceni zdravila (EPAR) in povzetek načrta obvladovanja tveganj za zdravilo Odomzo sta na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The main measure of effectiveness was the response to treatment, based on a reduction in tumour size and improvement in other signs of cancer; treatment was considered sufficiently effective if the response rate was at least 30%. 
Glavno merilo učinkovitosti je bil odziv na zdravljenje, ki je temeljil na zmanjšanju velikosti tumorjev in izboljšanju drugih znakov raka; zdravljenje je bilo zadostno učinkovito, če je bil delež odziva vsaj 30-odstoten.
Furthermore, the company is to supply further analysis from its main study on the effectiveness and safety of Odomzo, including its effectiveness in rapidly growing and slow-growing basal cell carcinoma. 
Poleg tega bo družba priskrbela dodatno analizo svoje glavne študije glede učinkovitosti in varnosti zdravila Odomzo, vključno z njegovo učinkovitostjo pri hitro in počasi rastočem bazalnoceličnem karcinomu.
The company is also required to analyse available tumour material from patients whose cancer worsened despite treatment, in order to determine why the treatment did not work. 
Družba mora prav tako analizirati razpoložljiv material tumorjev, pridobljen pri bolnikih, pri katerih se je rak poslabšal kljub zdravljenju, da bo ugotovila, zakaj zdravljenje ni delovalo.
Odomzo is continued as long as it has a beneficial effect or until it can no longer be taken because of side effects. 
Zdravilo Odomzo se uporablja, dokler ima koristen učinek ali ga bolnik ne more več jemati zaradi neželenih učinkov.
What benefits of Odomzo have been shown in studies? 
Kakšne koristi je zdravilo Odomzo izkazalo v študijah?
It will also supply educational material to doctors and to patients, including a reminder card about the risks of the medicine and, in particular, the possibility of serious harm to the unborn baby if Odomzo is taken during pregnancy. 
Prav tako bo priskrbela izobraževalno gradivo za zdravnike in bolnike, vključno s kratico z opomniki glede tveganj pri zdravilu in predvsem možnosti resne poškodbe nerojenega otroka, če se zdravilo Odomzo jemlje med nosečnostjo.
What is Odomzo and what is it used for? 
Kaj je zdravilo Odomzo in za kaj se uporablja?
This is a summary of the European public assessment report (EPAR) for Odomzo. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Odomzo.
A risk management plan has been developed to ensure that Odomzo is used as safely as possible. 
Za zagotovitev čim varnejše uporabe zdravila Odomzo je bil pripravljen načrt obvladovanja tveganj.
Patients were started on two different doses of Odomzo: 200 or 800 mg once a day. 
Bolniki so začeli z dvema različnima odmerkoma zdravila Odomzo: 200 ali 800 mg enkrat na dan.
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Odomzo'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 Odomzo večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
This pathway normally controls a number of cell activities including cell growth and how cells develop correctly to make up different body organs in unborn babies. 
Ta pot običajno nadzoruje številne celične dejavnosti, med drugim celično rast in pravilen razvoj celic, ki nato sestavljajo različne telesne organe še nerojenih otrok.
Other information about Odomzo 
Druge informacije o zdravilu Odomzo
Some cancers, including basal cell carcinoma, result from overactivity of a specific set of cell processes called the Hedgehog signalling pathway. 
Nekatere vrste raka, vključno z bazalnoceličnim karcinomom, so posledica čezmerne dejavnosti posebnega niza celičnih procesov, imenovanega signalna pot Hedgehog.