natgillin/translations-raw huggingface dataset:
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.
Of those with locally advanced basal cell carcinoma, around 56% (37 of 66 patients) on the 200-mg dose and 45% (58 of 128 patients) started on the 800-mg dose responded to treatment.
Od primerov lokalno napredovalega bazalnoceličnega karcinoma se jih je na zdravljenje odzvalo približno 56 % (37 od 66 bolnikov) na odmerku 200 mg in 45 % (58 od 128 bolnikov) na začetnem odmerku 800 mg.
What are the risks associated with Odomzo?
Kakšna tveganja so povezana z zdravilom Odomzo?
It is not intended to provide practical advice on how to use Odomzo.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
Odomzo is available as capsules (200 mg) and the recommended dose is one capsule taken once a day at least two hours after the last meal and an hour before the next.
Priporočeni odmerek je ena kapsula enkrat na dan vsaj dve uri po zadnjem obroku in eno uro pred naslednjim obrokom.
Odomzo is a cancer medicine used to treat adults with basal cell carcinoma (a type of skin cancer) which is locally advanced (has started to spread nearby) and which cannot be treated either by surgery or by radiotherapy (treatment with radiation).
Odomzo je zdravilo proti raku, ki se uporablja za zdravljenje odraslih z bazalnoceličnim karcinomom (vrsto kožnega raka), ki je lokalno napredoval (se razširil v svoji okolici) in ga ni mogoče zdraviti s kirurškim posegom ali radioterapijo (obsevanjem).
It should only be prescribed by a specialist doctor experienced in the treatment of advanced basal cell carcinoma or under the supervision of such a doctor.
Zdravilo sme predpisati le zdravnik specialist, ki ima izkušnje z zdravljenjem napredovalega bazalnoceličnega karcinoma, oziroma se sme predpisati le pod nadzorom takega zdravnika.
The Committee considered that the benefits of Odomzo had been shown for patients with locally advanced disease.
Odbor je menil, da so bile koristi zdravila Odomzo dokazane za bolnike z lokalno napredovalo boleznijo.
Odomzo was studied in one main study involving 230 patients with basal cell carcinoma which was either locally advanced or metastatic (spread to other parts of the body).
Zdravilo Odomzo so proučevali v eni glavni študiji, ki je vključevala 230 bolnikov z bazalnoceličnim karcinomom, ki je lokalno napredoval ali metastaziral (se je razširil na druge dele telesa).
By attaching to this protein, sonidegib blocks the Hedgehog signalling pathway and thereby reduces the growth and spread of cancer cells.
Sondegib z vezavo na to beljakovino zavira signalno pot Hedgehog in tako zmanjša rast ter širjenje rakavih celic.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Odomzo, including the precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila Odomzo in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
For more information about treatment with Odomzo, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Odomzo preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Why is Odomzo approved?
Zakaj je bilo zdravilo Odomzo odobreno?
Response rates were less than 20% in patients with metastatic cancer started on either 200 or 800 mg Odomzo and the company withdrew its application for use in metastatic basal cell carcinoma.
Pri bolnikih z metastatskim rakom na začetnem odmerku zdravila Odomzo 200 ali 800 mg je bil delež odziva manjši od 20 %, zato je družba umaknila svojo vlogo za uporabo pri metastatskem bazalnoceličnem karcinomu.
For practical information about using Odomzo, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Odomzo naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
Odomzo can only be obtained with a prescription.
Izdaja zdravila Odomzo je le na recept.
Sonidegib, the active substance in Odomzo, attaches to a protein that controls the Hedgehog signalling pathway.
Sonidegib, zdravilna učinkovina v zdravilu Odomzo, se veže na beljakovino, ki nadzoruje signalno pot Hedgehog.
Women who could potentially become pregnant must not take Odomzo unless they comply with the Odomzo pregnancy prevention programme.
Ženske v rodni dobi ne smejo jemati zdravila Odomzo, če ne upoštevajo programa za preprečevanje nosečnosti pri jemanju zdravila Odomzo.
Women who are pregnant or who are breastfeeding must not take Odomzo.
Nosečnice in doječe matere ne smejo jemati zdravila Odomzo.
In addition, the company will send a letter to doctors when Odomzo is launched.
Poleg tega bo družba ob dajanju zdravila Odomzo v promet zdravnikom poslala dopis.
Therefore, women taking Odomzo must take effective measures to prevent pregnancy during treatment and for 20 months after stopping it. Men taking Odomzo must always use condoms for sex with female partners and for 6 months after stopping treatment.
Moški, ki jemljejo zdravilo Odomzo, morajo med zdravljenjem in 6 mesecev po njegovi prekinitvi vedno uporabljati kondome, kadar imajo spolne odnose z ženskami.
How does Odomzo work?
Kako zdravilo Odomzo deluje?
Odomzo contains the active substance sonidegib.
Zdravilo Odomzo vsebuje zdravilno učinkovino sonidegib.
For the full list of all side effects reported with Odomzo, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Odomzo, glejte navodilo za uporabo.
How is Odomzo used?
Kako se zdravilo Odomzo uporablja?