FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Slovenian: 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.
English: Do not use if box has been opened.
Slovenian: Če so vidni znaki odprtja, zdravila ne smete uporabiti.
English: 2.00 (1.54, 2.59), P<0.0001
Slovenian: s placebom 2,00 (1,54; 2,59), p < 0,0001 1,77 (1,33; 2,36), p < 0,0001 NRT v prim.
English: 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
Slovenian: 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
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister pack of 14 x 1 mg varenicline film-coated tablets, heat sealed card
Slovenian: Pretisni omot s 14 filmsko obloženimi tabletami po 1 mg vareniklina v toplotno zavarjenem pakiranju
English: 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,
Slovenian: • povečana mišična napetost, težave pri govoru, težave s koordinacijo, zmanjšana sposobnost okušanja, spremenjen vzorec spanja
English: It also considered that the side effects were manageable.
Slovenian: Prav tako je menil, da so neželeni učinki obvladljivi.
English: What measures are being taken to ensure the safe and effective use of Odomzo?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Odomzo?
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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%.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Odomzo is continued as long as it has a beneficial effect or until it can no longer be taken because of side effects.
Slovenian: Zdravilo Odomzo se uporablja, dokler ima koristen učinek ali ga bolnik ne more več jemati zaradi neželenih učinkov.
English: What benefits of Odomzo have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Odomzo izkazalo v študijah?
English: 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.
Slovenian: 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.
English: What is Odomzo and what is it used for?
Slovenian: Kaj je zdravilo Odomzo in za kaj se uporablja?
English: This is a summary of the European public assessment report (EPAR) for Odomzo.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Odomzo.
English: A risk management plan has been developed to ensure that Odomzo is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila Odomzo je bil pripravljen načrt obvladovanja tveganj.
English: Patients were started on two different doses of Odomzo: 200 or 800 mg once a day.
Slovenian: Bolniki so začeli z dvema različnima odmerkoma zdravila Odomzo: 200 ali 800 mg enkrat na dan.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: Ta pot običajno nadzoruje številne celične dejavnosti, med drugim celično rast in pravilen razvoj celic, ki nato sestavljajo različne telesne organe še nerojenih otrok.
English: Other information about Odomzo
Slovenian: Druge informacije o zdravilu Odomzo
English: Some cancers, including basal cell carcinoma, result from overactivity of a specific set of cell processes called the Hedgehog signalling pathway.
Slovenian: Nekatere vrste raka, vključno z bazalnoceličnim karcinomom, so posledica čezmerne dejavnosti posebnega niza celičnih procesov, imenovanega signalna pot Hedgehog.
English: 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.
Slovenian: 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.
English: What are the risks associated with Odomzo?
Slovenian: Kakšna tveganja so povezana z zdravilom Odomzo?
English: It is not intended to provide practical advice on how to use Odomzo.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: 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.
Slovenian: Priporočeni odmerek je ena kapsula enkrat na dan vsaj dve uri po zadnjem obroku in eno uro pred naslednjim obrokom.
English: 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).
Slovenian: 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).
English: 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.
Slovenian: Zdravilo sme predpisati le zdravnik specialist, ki ima izkušnje z zdravljenjem napredovalega bazalnoceličnega karcinoma, oziroma se sme predpisati le pod nadzorom takega zdravnika.
English: The Committee considered that the benefits of Odomzo had been shown for patients with locally advanced disease.
Slovenian: Odbor je menil, da so bile koristi zdravila Odomzo dokazane za bolnike z lokalno napredovalo boleznijo.
English: 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).
Slovenian: 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).
English: By attaching to this protein, sonidegib blocks the Hedgehog signalling pathway and thereby reduces the growth and spread of cancer cells.
Slovenian: Sondegib z vezavo na to beljakovino zavira signalno pot Hedgehog in tako zmanjša rast ter širjenje rakavih celic.
English: 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.
Slovenian: 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.
English: For more information about treatment with Odomzo, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: 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.
English: Why is Odomzo approved?
Slovenian: Zakaj je bilo zdravilo Odomzo odobreno?
English: 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.
Slovenian: 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.
English: For practical information about using Odomzo, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Odomzo naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: Odomzo can only be obtained with a prescription.
Slovenian: Izdaja zdravila Odomzo je le na recept.
English: Sonidegib, the active substance in Odomzo, attaches to a protein that controls the Hedgehog signalling pathway.
Slovenian: Sonidegib, zdravilna učinkovina v zdravilu Odomzo, se veže na beljakovino, ki nadzoruje signalno pot Hedgehog.
English: Women who could potentially become pregnant must not take Odomzo unless they comply with the Odomzo pregnancy prevention programme.
Slovenian: Ženske v rodni dobi ne smejo jemati zdravila Odomzo, če ne upoštevajo programa za preprečevanje nosečnosti pri jemanju zdravila Odomzo.
English: Women who are pregnant or who are breastfeeding must not take Odomzo.
Slovenian: Nosečnice in doječe matere ne smejo jemati zdravila Odomzo.
English: In addition, the company will send a letter to doctors when Odomzo is launched.
Slovenian: Poleg tega bo družba ob dajanju zdravila Odomzo v promet zdravnikom poslala dopis.
English: 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.
Slovenian: Moški, ki jemljejo zdravilo Odomzo, morajo med zdravljenjem in 6 mesecev po njegovi prekinitvi vedno uporabljati kondome, kadar imajo spolne odnose z ženskami.
English: How does Odomzo work?
Slovenian: Kako zdravilo Odomzo deluje?
English: Odomzo contains the active substance sonidegib.
Slovenian: Zdravilo Odomzo vsebuje zdravilno učinkovino sonidegib.
English: For the full list of all side effects reported with Odomzo, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Odomzo, glejte navodilo za uporabo.
English: How is Odomzo used?
Slovenian: Kako se zdravilo Odomzo uporablja?
English: Substances that affect the Hedgehog pathway can result in serious harm to an unborn baby.
Slovenian: Snovi, ki vplivajo na signalno pot Hedgehog, lahko resno poškodujejo nerojenega otroka, zato morajo ženske, ki jemljejo zdravilo Odomzo, med zdravljenjem in 20 mesecev po njegovi prekinitvi upoštevati učinkovite ukrepe za preprečevanje nosečnosti.
English: Subcutaneos use
Slovenian: Subkutana uporaba
English: Vial (glass)
Slovenian: Viala (steklo)
English: Strength Pharmaceutical Form Route of Administration
Slovenian: Izmišljeno ime Jakost farmacevtska oblika pot uporabe
English: 1 bottle + 1 oral syringe + 1 press-in bottle adapter
Slovenian: 1 plastenka + 1 brizga za peroralno dajanje + 1 nastavek za plastenko
English: 10 mg/ml
Slovenian: 10 mg/ml prašek za peroralno suspenzijo peroralna uporaba plastenka (HDPE)
English: However, you can still wear normal clothing.
Slovenian: Seveda pa se lahko normalno oblečete.
English: • Wash and dry your hands.
Slovenian: • Umijte in obrišite si roke.
English: Your doctor will be able to tell you if this is necessary.
Slovenian: Vaš zdravnik vam po povedal, če bo to potrebno.
English: The first report will be provided in 2007 and this requirement will be reevaluated on a regular basis.
Slovenian: Prvo poročilo bo pripravljeno leta 2007, ta zahteva pa se bo redno preverjala.
English: Do not use it in your nose, eyes or mouth.
Slovenian: Ne nanašajte je v nos, oči ali usta.
English: Whitish and homogeneous.
Slovenian: Belkasta in homogena.
English: {Name and Address} <{tel}> <{fax}> <{e-mail}>
Slovenian: {Ime in naslov} <{tel.}> <{fax}> <{e-mail}>
English: It does not contain any steroids.
Slovenian: Ne vsebuje nobenih steroidov.
English: The cream should be applied twice daily, for instance once in the morning and once in the evening.
Slovenian: Kremo je treba nanašati dvakrat dnevno, na primer enkrat zjutraj in enkrat zvečer.
English: Improvement 2
Slovenian: Izboljšanje 2
English: Therefore it should not be used in this age group.
Slovenian: Pri tej starostni skupini se je torej ne sme uporabljati.
English: Independent DSMB
Slovenian: Neodvisni DSMB
English: Frequency of application greater than twice daily has not been studied.
Slovenian: Pogostnost uporabe, večje od dvakrat na dan, ni bila proučena.
English: In general, these data are not conclusive and the studies have weaknesses which limit their interpretation.
Slovenian: V splošnem ti podatki niso prepričljivi, študije pa vsebujejo šibke točke, ki omejujejo interpretacijo teh podatkov.
English: Risk Management Plan
Slovenian: Načrt za obvladovanje tveganj
English: Registry Study (C2311)
Slovenian: Registrska študija (C2311)
English: Study C2308
Slovenian: Študija C2308
English: Therefore, Annex III may not necessarily represent the current text.
Slovenian: Dodatek III torej ne predstavlja nujno najnovejše različice besedila.
English: After first opening the container: 12 months.
Slovenian: Po prvem odpiranju tube: 12 mesecev.
English: Carefully follow all instructions given to you by your doctor.
Slovenian: Skrbno se ravnajte po navodilih, ki vam jih je dal vaš zdravnik.
English: In these three 6-week studies, the efficacy results at endpoint were as follows:
Slovenian: Pri vseh treh šesttedenskih raziskavah je bila končna učinkovitost sledeča:
English: The data of both studies were pooled.
Slovenian: Podatki iz obeh raziskav so bili združeni.
English: Occlusive dressings are not recommended.
Slovenian: Okluzivni zavoji niso priporočeni.
English: The main reasons include too short lengths of exposure, too short durations of follow-up and methodological shortcomings.
Slovenian: Glavni razlogi zajemajo prekratek čas izpostavitve, prekratko trajanje spremljanja in pa metodološke pomanjkljivosti.
English: Short-term (acute) treatment:
Slovenian: Kratkotrajno (akutno) zdravljenje
English: 59.9% 33% not done
Slovenian: 59,9% 33% Ni bila izračuna -na.
English: This will be re-evaluated on a regular basis.
Slovenian: To se bo redno preverjalo.
English: The affected BSA ranged from 10-92%.
Slovenian: Prizadeta BSA je bila od 10-92%.
English: Sintra Portugal
Slovenian: Sintra Portugalska
English: Interactions with other medicines that you take are unlikely to occur.
Slovenian: Medsebojno delovanje z drugimi zdravili, ki jih jemljete, je malo verjetno.
English: Clear or almost clear 1
Slovenian: Ozdravljen ali skoraj ozdravljen 1
English: A significant improvement in pruritus was observed within the first week of treatment in 44% of children and adolescents and in 70% of infants.
Slovenian: Značilno izboljšanje pruritusa je bilo opaženo v prvem tednu zdravljenja pri 44% otrok in mladostnikov ter pri 70% dojenčkov.
English: Long-term clinical trials were 1 year in duration.
Slovenian: Dolgotrajna klinična preskušanja so trajala 1 leto.
English: • Squeeze the cream onto your finger.
Slovenian: • Iztisnite nekaj kreme na prst.
English: If signs and symptoms return you should start treatment again.
Slovenian: Če se znaki in simptomi ponovijo, ponovno začnite z zdravljenjem.
English: Do not use for other skin conditions.
Slovenian: Ne uporabljajte je za druge spremembe na koži.
English: 68% 40% Not done
Slovenian: 68% 40% Ni bila izračunana.
English: PHARMACEUTICAL FORM Cream.
Slovenian: FARMACEVTSKA OBLIKA Krema.
English: After the Commission Decision, the Member State competent authorities will update Annex III as required.
Slovenian: Po odločbi Komisije bodo pristojne oblasti držav članic Dodatek III posodobile v skladu z zahtevami.
English: Frequency estimates: very common (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1,000, <1/100); rare (≥1/10,000, <1/1,000); very rare (<1/10,000, including isolated reports).
Slovenian: Ocene pogostnosti: zelo pogosti (≥1/10); pogosti(≥1/100, <1/10); občasni (≥1/1,000, <1/100); redki(≥1/10,000, <1/1,000); zelo redki (<1/10.000, vključno s posameznimi poročili).
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF MEDICINAL PRODUCTS CONTAINING PIMECROLIMUS (see Annex I)
Slovenian: SPLOŠNI POVZETEK ZNANSTVENE OCENE ZDRAVIL, KI VSEBUJEJO PIMEKROLIMUS (glejte Dodatek I)
English: Total mean recovery of radioactivity was 80.9%.
Slovenian: Celotni povprečni prestrezek radioaktivnosti je bil 80,9%.
English: Continue using the cream for as long as your doctor advises.
Slovenian: Z uporabo kreme nadaljujte tako dolgo, kot vam svetuje zdravnik.
English: However a local immunosuppressive effect in the skin cannot be excluded.
Slovenian: Kljub temu pa lokalnega imunosupresivnega učinka v koži ni mogoče izključiti.
English: Tubes of 15, 30, 60 and 100 grams.
Slovenian: Tube s 15, 30, 60 in 100 grami.
English: You should take care not to swallow it, or to accidentally transfer it into your mouth when for example it is applied to the hands.
Slovenian: Pazite, da kreme ne bi zaužili ali je nehote prenesli v usta, kadar jo naprimer nanašate na roke.
English: Half of the patients in the control group received topical corticosteroids for more than 95% of study days.
Slovenian: Polovica bolnikov v kontrolni skupini je dobivala lokalne kortikosteroide več kot 95% dni raziskave.
English: {pimecrolimus}
Slovenian: {pimekrolimus}
English: Pharmacological/Mechanistic Studies
Slovenian: Farmakološke/Mehanistične študije
English: The malignancies reported were very diverse in their origin and location.
Slovenian: Maligna obolenja, o katerih so poročali, so bila po svojem izvoru in mestu pojavljanja zelo različna.
English: DK-2100 København Ø, Denmark
Slovenian: DK-2100 København Ø, Danska
English: This helps to prevent progression to severe flare-ups.
Slovenian: To pomaga preprečevati napredovanje bolezni do hudih izbruhov.
English: This is reflected by the findings from the fertility study.
Slovenian: To odsevajo rezultati raziskave plodnosti.
English: This should encompass all age groups including those aged <2 years.
Slovenian: V to morajo biti vključene vse starostne skupine, vključno s tistimi, katerih starost znaša manj kot dve leti.
English: For children (2-11 years) and adolescents (12-17 years) the posology and method of administration are the same as for adults.
Slovenian: Pri otrocih (2-11 let) in mladostnikih (12-17 let) so priporočila za odmerjanje in način uporabe enaka kot pri odraslih.
English: This could wash off the cream.
Slovenian: S tem bi kremo lahko sprali s kože.
English: Pimecrolimus is exclusively metabolised by CYP 450 3A4.
Slovenian: Pimekrolimus presnavlja izključno CYP 450 3A4.
English: In accordance with the “Guideline on risk management systems for medicinal products for human use (EMEA/CHMP/96268/2005)”, the MAHs should provide a full Risk Management Plan to the RMS.
Slovenian: Skladno s "Smernicami za sisteme obvladovanja tveganj v zvezi z zdravili za uporabo v humani medicini (EMEA/CHMP/96268/2005)", morajo imetniki dovoljenja za promet z zdravilom referenčni državi članici zagotoviti celovit načrt za obvladovanje tveganj.
English: In patients with severely inflamed and/or damaged skin, the systemic concentrations may be higher.
Slovenian: Pri bolnikih s hudo vneto in/ali poškodovano kožo pride lahko do večjih sistemskih koncentracij.
English: Apply the cream as follows:
Slovenian: Kremo uporabljajte takole:
English: Special studies
Slovenian: Posebne raziskave
English: They were in a range similar to that measured in adult patients.
Slovenian: Po razponu so bile podobne koncentracijam, izmerjenim pri odraslih bolnikih.
English: A Dear Healthcare professional letter should be sent to relevant Healthcare professionals on 3 April
Slovenian: Pismo z naslovom Spoštovani zdravnik je treba zadevnim zdravnikom poslati 3. aprila 2006.
English: Overall (mean % change)3
Slovenian: Na splošno (povprečna sprememba v %)3
English: Pharmacotherapeutic group: Other dermatologicals, ATC code: D11AX15
Slovenian: Farmakoterapevtska skupina: druga dermatološka zdravila, Oznaka ATC: D11AX15
English: Therefore the CHMP requested that the MAH should take the appropriate measures in order to ensure that Elidel is not used in this age group.
Slovenian: Zato je CHMP zahteval, da mora imetnik dovoljenja za promet z zdravilom sprejeti ustrezne ukrepe, s katerimi bi zagotovil, da se Elidel ne bo uporabljal pri tej starostni skupini.
English: The timelines will depend on the scope of the re-analysis, which will be clarified with the RMS.
Slovenian: Časovni roki bodo odvisni od obsega ponovne analize, kar bo podrobneje pojasnila referenčna država članica.
English: 1: p-value based on CMH test stratified by centre
Slovenian: 1: Vrednost p temelji na testu CMH, stratificiranem po centrih.
English: Novartis Norge AS Postboks 237 Økern 0510 Oslo Norway
Slovenian: Novartis Norge AS Postboks 237 Økern 0510 Oslo Norveška
English: Atopic dermatitis (eczema) is rarely observed in patients aged 65 and over.
Slovenian: Atopijski dermatitis (ekcem) je redko opažen pri bolnikih, starih 65 let in več.
English: Novartis Hungária Kft. Pharma 1114 Budapest, Bartók Béla út 43-47.
Slovenian: Madžarska Novartis Hungária Kft. Pharma 1114 Budapest, Bartók Béla út 43-47.