FrancophonIA/ELRC3.0 huggingface dataset:
English: The study in younger children (aged 2 to 4 years) showed that the majority of children responded well to Humira treatment and this response was maintained after 24 weeks.
Slovenian: Študija pri mlajših otrocih (starih od dve do štiri leta) je pokazala, da se je večina otrok dobro odzvala na zdravljenje z zdravilom Humira in da se je odziv ohranil še po 24 tednih.
English: What benefits of Humira have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Humira izkazalo v študijah?
English: • In non-infectious uveitis, Humira was found effective in 3 studies.
Slovenian: • Pri neinfektivnem uveitisu se je zdravilo Humira izkazalo za učinkovito v treh študijah.
English: An overview of Humira and why it is authorised in the EU
Slovenian: Pregled zdravila Humira in zakaj je odobreno v EU
English: Patients or their carers can inject Humira once they have been trained.
Slovenian: Bolniki ali njihovi negovalci si lahko zdravilo Humira vbrizgajo sami, ko so bili ustrezno usposobljeni.
English: The first study involved adults whose disease was not controlled with high doses of corticosteroids.
Slovenian: V prvo študijo so bili vključeni odrasli bolniki, pri katerih bolezen ni bila nadzorovana z velikimi odmerki kortikosteroidov.
English: Humira is a medicine that acts on the immune system and is used to treat the following conditions:
Slovenian: Humira je zdravilo, ki učinkuje na imunski sistem in se uporablja za zdravljenje naslednjih bolezni:
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Humira have also been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Humira upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: Humira is mostly used in adults when their conditions are severe, moderately severe or getting worse, or when patients cannot use other treatments.
Slovenian: Zdravilo Humira se večinoma uporablja pri odraslih, katerih bolezen je huda, zmerno huda ali se poslabšuje oziroma kadar bolnik ne more prejemati drugega zdravljenja.
English: Patients treated with Humira must be given a reminder card with information on the safety of the medicine.
Slovenian: Bolniki, ki se zdravijo z zdravilom Humira, morajo prejeti opozorilno kartico z informacijami o varnosti zdravila.
English: Humira must not be used in patients with active tuberculosis or other severe infections, or in patients with moderate to severe heart failure (an inability of the heart to pump enough blood around the body).
Slovenian: Zdravilo Humira se ne sme uporabljati pri bolnikih z aktivno tuberkulozo ali drugimi hudimi okužbami ali pri bolnikih z zmernim do hudim srčnim popuščanjem (stanjem, pri katerem srce ne zmore črpati dovolj krvi po telesu).
English: The proportions of patients taking placebo who achieved this goal were 28% in the first study and 26% in the second.
Slovenian: Takšen rezultat je v skupini bolnikov, ki je jemala placebo, doseglo 28 % v prvi študiji in 26 % bolnikov v drugi.
English: The active substance in Humira, adalimumab, is a monoclonal antibody (a type of protein) that has been designed to recognise and attach to a substance in the body called tumour necrosis factor (TNF).
Slovenian: Učinkovina v zdravilu Humira, adalimumab, je monoklonsko protitelo (vrsta beljakovine), ki je bilo zasnovano tako, da v telesu prepozna snov, imenovano tumorje nekrotizirajoči faktor (TNF), in se veže nanj.
English: The dose and frequency of injection depends on the condition to be treated and the dose for a child is calculated according to the child's weight.
Slovenian: Odmerek in pogostnost injiciranja sta odvisna od bolezni, ki se zdravi, pri otrocih pa se odmerek izračuna na podlagi otrokove telesne mase.
English: Humira, when used as directed, has been shown in clinical trials to be effective at reducing important symptoms of each of the conditions for which it is approved.
Slovenian: Zdravilo Humira se je v kliničnih preskušanjih ob pravilni uporabi izkazalo za učinkovito pri zmanjševanju glavnih simptomov pri vsaki od bolezni, za katere je bilo odobreno.
English: Side effects reported with Humira are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o kateri so poročali pri zdravilu Humira, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
English: Humira and other medicines of its class may also affect the ability of the immune system to fight off infections and cancer, and there have been some cases of serious infections and blood cancers in patients using Humira.
Slovenian: Zdravilo Humira in druga zdravila iz istega razreda lahko vplivajo tudi na obrambno sposobnost imunskega sistema proti okužbam in raku, saj so bili pri bolnikih, ki prejemajo zdravilo Humira, zabeleženi nekateri primeri resnih okužb in krvnega raka.
English: In patients who had not taken methotrexate in the past, the combination of Humira and methotrexate was also more effective than methotrexate alone.
Slovenian: Pri bolnikih, ki v preteklosti še niso prejemali metotreksata, je bila kombinacija zdravila Humira in metotreksata učinkovitejša od metotreksata kot samostojnega zdravila.
English: This substance is involved in causing inflammation and is found at high levels in patients with the diseases that Humira is used to treat.
Slovenian: Ta snov sodeluje pri nastanku vnetij in je prisotna v visokih koncentracijah pri bolnikih z boleznimi, za katere se zdravilo Humira uporablja.
English: For detailed information on the use of Humira in all conditions, including when it can be used in children, see package leaflet or contact your doctor or pharmacist.
Slovenian: Za podrobne informacije o uporabi zdravila Humira pri vseh navedenih boleznih, vključno s tem, kdaj se lahko uporablja pri otrocih, glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
English: The second study involved adults whose uveitis was under control with a corticosteroid but the corticosteroid dose was then reduced or stopped and Humira or placebo introduced.
Slovenian: V drugo študijo so bili vključeni odrasli bolniki, katerih uveitis je bil pod nadzorom s kortikosteroidom, vendar je bil pri njih odmerek nato zmanjšan ali so ga prenehali jemati ter začeli prejemati zdravilo Humira ali placebo.
English: The most common side effects with Humira (which may affect more than 1 in 10 people) are infections (including in the nose, throat and sinuses), injection site reactions (redness, itching, bleeding, pain or swelling), headache and muscle and bone pain.
Slovenian: Najpogostejši neželeni učinki zdravila Humira (ki se lahko pojavijo pri več kot 1 bolniku od 10) so okužbe (nosu, grla in sinusov), reakcije na mestu injiciranja (rdečina, srbenje, krvavenje, bolečina ali oteklina), glavobol ter bolečine v mišicah in kosteh.
English: Other rare serious side effects (which may affect up to 1 in 1,000 people) include failure of bone marrow to produce blood cells, disorder of the nerves, lupus and lupus-like conditions (where the immune system attacks the patient's own tissues, causing inflammation and organ damage), and Stevens-Johnson syndrome (a life-threatening reaction with flu-like symptoms and painful rash affecting the skin, mouth, eyes and genitals).
Slovenian: Drugi redki resni neželeni učinki (ki se lahko pojavijo pri največ 1 bolniku od 1 000) vključujejo nezmožnost kostnega mozga za proizvodnjo krvnih celic, motnje živčevja, lupus in lupusu podoben sindrom (obolenje, pri katerem imunski sistem napada bolnikova lastna tkiva, kar povzroča vnetje in poškodbe organov) in Stevens-Johnsonov sindrom (življenjsko nevarna reakcija z gripi podobnimi simptomi in bolečim izpuščajem, ki prizadene kožo, usta, oči in spolovila).
English: How is Humira used?
Slovenian: Kako se zdravilo Humira uporablja?
English: • In hidradenitis suppurativa, 59% of patients receiving Humira in one main study and 42% of patients in another achieved at least a 50% reduction in abscesses and nodules after 12 weeks, without any increase in abscess count or fistulas.
Slovenian: • Pri obolenju hidradenitis suppurativa je v eni glavni študiji pri 59 % bolnikov, ki so prejemali zdravilo Humira, in v drugi pri 42 % po 12 tednih prišlo do vsaj 50-odstotnega zmanjšanja abscesov in nodulov, ne da bi se povečalo število abscesov ali fistul.
English: How does Humira work?
Slovenian: Kako zdravilo Humira deluje?
English: • axial spondyloarthritis (inflammation of spine causing back pain), including ankylosing spondylitis and when X-ray does not show disease but there are clear signs of inflammation
Slovenian: • aksialnega spondiloartritisa (vnetja hrbtenice, ki povzroča bolečine v hrbtu), vključno ankilozirajočega spondilitisa, in kadar rentgenska slika ne kaže poškodb, so pa prisotni očitni znaki vnetja;
English: The studies included adult patients for the most part, but included children in studies for Crohn's disease, plaque psoriasis, polyarticular juvenile idiopathic arthritis, non-infectious anterior uveitis and enthesitis-related arthritis.
Slovenian: Večina bolnikov v teh študijah je bila odraslih, otroci pa so bili vključeni v študije Crohnove bolezni, psoriaze v plakih, poliartikularnega juvenilnega idiopatskega artritisa, neinfektivnega uveitisa in artritisa, povezanega z entezitisom.
English: In the third study in children aged 2 to 18 years with non-infectious anterior uveitis, in whom methotrexate alone did not work, treatment failed in about 60% of patients receiving placebo with methotrexate compared with about 27% of patients given Humira with methotrexate.
Slovenian: V tretji študiji z otroki, starimi med dve in 18 let, ki so imeli predhodni neinfektivni uveitis in pri katerih samostojno jemanje metotreksata ni delovalo, zdravljenje ni bilo uspešno pri okoli 60 % bolnikov, ki so prejemali placebo v kombinaciji z metotreksatom, v primerjavi s 27 % bolnikov, ki so prejemali zdravilo Humira v kombinaciji z metotreksatom.
English: Patients adding Humira also had less joint damage and less reduction in physical function after a year.
Slovenian: Bolniki, ki so kot dodatek prejemali zdravilo Humira, so imeli po enem letu zdravljenja tudi manj poškodb sklepov in manjše poslabšanje telesnih zmogljivosti.
English: For more information about using Humira, see the package leaflet or contact your doctor or pharmacist.
Slovenian: Za več informacij o uporabi zdravila Humira glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
English: • Humira also produced a greater improvement in symptoms than placebo in studies of psoriatic arthritis, ankylosing spondylitis, axial spondyloarthritis without evidence in the X-ray of ankylosing spondylitis but with clear signs of inflammation, and induction and maintenance phases of treatment for Crohn's disease, psoriasis and ulcerative colitis.
Slovenian: • Prav tako je zdravilo Humira bolj izboljšalo simptome kot placebo v študijah psoriatičnega artritisa, ankilozirajočega spondilitisa, aksialnega spondiloartritisa, pri katerem ankilozirajoči spondilitis ni dokazan z rentgenom, a je opaziti jasne znake vnetja, ter pri uvodnem in vzdrževalnem zdravljenju Crohnove bolezni, psoriaze in ulceroznega kolitisa.
English: Humira has been studied extensively and has been shown to be effective at reducing symptoms in patients with inflammatory conditions.
Slovenian: Za zdravilo Humira so bile opravljene obsežne študije, ki so pokazale, da je učinkovito pri zmanjševanju simptomov pri bolnikih z vnetnimi obolenji.
English: Doctors treating uveitis should also take advice from doctors who have experience of using Humira.
Slovenian: Zdravniki, ki zdravijo uveitis, se morajo posvetovati z zdravniki, ki imajo izkušnje z uporabo zdravila Humira.
English: Fewer patients receiving Humira with methotrexate developed antibodies against Humira (which can reduce its effects), so the results found that the use of Humira with methotrexate was more effective than Humira used alone.
Slovenian: V skupini bolnikov, ki so jemali zdravilo Humira v kombinaciji z metotreksatom, je bilo manj tistih, pri katerih so se razvila protitelesa (kar lahko prepreči delovanje zdravila), zaradi česar je bilo na podlagi rezultatov ugotovljeno, da je uporaba zdravila Humira v kombinaciji z metotreksatom učinkovitejša od jemanja zdravila Humira kot samostojnega zdravila.
English: • In studies in adults and children with plaque psoriasis, including psoriasis of the nail, a higher proportion of patients receiving Humira had improvements in symptoms compared with patients receiving methotrexate or placebo (a dummy treatment).
Slovenian: • Študije pri odraslih in otrocih s psoriazo v plakih, vključno s psoriazo nohtov, so pokazale, da je do izboljšanja simptomov prišlo pri več bolnikih, ki so jemali zdravilo Humira, kot pri tistih, ki so jemali metotreksat ali placebo (zdravilo brez učinkovine).
English: • plaque psoriasis, a disease causing red, scaly patches on the skin
Slovenian: • psoriaze s plaki, tj. bolezni, ki povzroča nastajanje rdečih, luskastih zaplat na koži;
English: Treatment with Humira must be started and supervised by a doctor who has experience in the treatment of the diseases that Humira is used for.
Slovenian: Zdravljenje z zdravilom Humira lahko uvede in nadzira le zdravnik, ki ima izkušnje z zdravljenjem bolezni, za katere se to zdravilo uporablja.
English: In this study, treatment failure occurred in about 55% of patients receiving placebo compared with 39% receiving Humira.
Slovenian: V tej študiji zdravljenje ni bilo uspešno pri približno 55 % bolnikov, ki so prejemali placebo, v primerjavi z 39 % bolnikov, ki so prejemali zdravilo Humira.
English: • In rheumatoid arthritis, the greatest reductions in symptoms were seen in the studies on Humira as an add-on to methotrexate: around two-thirds of the patients adding Humira had at least a 20% reduction in symptoms after six months, compared with a quarter of those adding placebo.
Slovenian: • Pri revmatoidnem artritisu so se simptomi najbolj zmanjšali v študijah, v katerih je bilo zdravilo Humira uporabljeno kot dodatek metotreksatu: približno dvema tretjinama bolnikov, ki so kot dodatek jemali zdravilo Humira, so se po šestih mesecih simptomi zmanjšali za najmanj 20 %, medtem ko je do takšnega zmanjšanja simptomov prišlo le pri četrtini bolnikov, ki so kot dodatek jemali placebo.
English: In this study treatment failed in about 79% of patients receiving placebo compared with about 55% given Humira.
Slovenian: V tej študiji zdravljenje ni bilo uspešno pri približno 79 % bolnikov, ki so prejemali placebo, v primerjavi s 55 % bolnikov, ki so prejemali zdravilo Humira.
English: • Crohn's disease (a disease causing inflammation of the gut)
Slovenian: • Crohnove bolezni (bolezni, ki povzroča vnetje črevesja);
English: • In polyarticular juvenile idiopathic arthritis, around 40% of patients aged between 4 and 17 years receiving Humira, either alone or in combination with methotrexate, had a flare-up of arthritis, compared with around 69% of those receiving placebo.
Slovenian: • Pri poliartikularnem juvenilnem idiopatskem artritisu je artritis ponovno izbruhnil pri približno 40 % bolnikov, starih od štiri do 17 let, ki so prejemali zdravilo Humira bodisi kot samostojno zdravilo bodisi v kombinaciji z metotreksatom, v primerjavi z 69 % tistih, ki so prejemali placebo.
English: For enthesitis-related arthritis, treatment with Humira resulted in fewer swollen and tender joints compared with placebo.
Slovenian: Pri artritisu, povezanem z entezitisom, je bilo pri jemanju zdravila Humira zabeleženih manj otečenih in bolečih sklepov v primerjavi z jemanjem placeba.
English: • psoriatic arthritis (red, scaly patches on the skin with inflammation of the joints)
Slovenian: • psoriatičnega artritisa (rdečih, luskastih zaplat na koži in vnetja sklepov);
English: For the full list of side effects of Humira, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Humira, glejte navodilo za uporabo.
English: More than twenty main studies involving over 9,500 patients have looked at the effects of Humira in reducing symptoms of inflammatory conditions.
Slovenian: Učinkovitost zdravila Humira pri zmanjševanju vnetnih stanj so proučevali v več kot dvajsetih glavnih študijah, v katerih je sodelovalo več kot 9 500 bolnikov.
English: Humira can only be obtained with a prescription.
Slovenian: Predpisovanje in izdaja zdravila Humira je le na recept.
English: For the full list of restrictions with Humira, see the package leaflet.
Slovenian: Za celoten seznam omejitev pri uporabi zdravila Humira glejte navodilo za uporabo.
English: Pharmaceutical form
Slovenian: Pharmaceutical Division
English: Aprotinin containing medicinal products with Marketing Authorisation in the European Union
Slovenian: Zdravila, ki vsebujejo aprotinin, z dovoljenjem za promet v Evropski uniji Država članica
English: D-13353 Berlin postal address:
Slovenian: 13353 Berlin poštni naslov:
English: BAYER SANTE - 220, avenue de la recherche - 59120 LOOS
Slovenian: FR-Francija BAYER SANTE 220, avenue de la recherche 59120 LOOS
English: 555,6 Ph.Eur.u.
Slovenian: 555,6 j. Ph.Eur.
English: TRASYLOL SOLUCIÓN PARA PERFUSIÓN INTRAVENOSA
Slovenian: TRASYLOL RAZTOPINA ZA INTRAVENSKO PERFUZIJO
English: BE-Belgium Belgium Bayer S.A. 14, J.E.
Slovenian: BE-Belgija Belgium Bayer S.A. 14, J.E.
English: Bayer Hellas AG 18 - 20 , Sorou Str.
Slovenian: EL-Grčija Bayer Hellas AG 18 - 20, Sorou Str.
English: 1111,1 Ph.Eur.u.
Slovenian: 1111,1 j. Ph.Eur.
English: 51368 Leverkusen, Germany
Slovenian: 51368 Leverkusen Nemčija
English: Bayer Healthcare AG Kaiser-Wilhelm-Allee, Bldg. E39
Slovenian: HU-Madžarska Bayer Healthcare AG Kaiser-Wilhelm-Allee, Bldg. E39
English: Member State (EU/EEA)
Slovenian: EU/EGP
English: UK - United Kingdom
Slovenian: UK-Velika Britanija
English: QUIMICA FARMACEUTICA BAYER, S.L
Slovenian: ES-Španija QUIMICA FARMACEUTICA BAYER, S.L.
English: Nordic Pharma Limited, Abbey House, 1650 Arlington Business Park, Theale, Reading, Berkshire RG7 4SA, UK
Slovenian: 1650 Arlington Business Park Theale, Reading Berkshire RG7 4SA Velika Britanija
English: 1103 Budapest, Hungary
Slovenian: HU-1103 Budapest
English: Bayer HealthCare AG, 51368 Leverkusen, Germany solution for injection/infusion intravenous use
Slovenian: FI-Finska Bayer HealthCare AG 51368 Leverkusen Nemčija raztopina za injiciranje / infundiranje
English: Quinta do Pinheiro 5 2794-003 Carnaxide Portugal
Slovenian: 2794-003 Carnaxide Portugalska
English: Trasylol 10.000 KIE/mlInfusionsflasche
Slovenian: Trasylol 10.000 KIE/ml - Infusionsflasche
English: Bayer Vital GmbH D-51373 Leverkusen
Slovenian: DE-Nemčija Bayer Vital GmbH 51368 Leverkusen Nemčija
English: Bayer Austria GmbH Herbststraße 6-10 A-1160 Wien Austria
Slovenian: AT-Avstrija Bayer Austria GmbH Herbststraße 6-10
English: Bayer Pharma AG Berlin, D-13342 Germany
Slovenian: PL-Poljska Bayer Pharma AG 13342 Berlin
English: Bayer Portugal, S.A.
Slovenian: Bayer S.A.
English: Bayer House Strawberry Hill Newbury
Slovenian: MT-Malta Bayer Plc Bayer House Strawberry Hill Newbury
English: Bayer Schering Pharma AG Müllerstrasse 178
Slovenian: SE-Švedska Bayer Schering Pharma AG Müllerstrasse 178
English: Gedeon Richter Ltd. Gyomroi ut 19-21 Budapest HU-1103 Hungary
Slovenian: LV - Latvija Gedeon Richter Ltd. Gyomroi ut 19-21
English: Berkshire RG14 1JA United Kingdom trading as Bayer Plc, Pharmaceutical division
Slovenian: Berkshire RG14 1JA Velika Britanija posluje kot
English: H-1475 Hungary
Slovenian: Pf. 27., H-1475
English: 1000000 U.I.C/100 ml
Slovenian: Trasylol 1.000.000 UIC 1000000 U.I.C / 100 ml
English: 2000000 U.I.C/200 ml
Slovenian: Trasylol 2.000.000 UIC 2000000 U.I.C / 200 ml
English: Richter Gedeon Nyrt., Budapest Pf. 27.,
Slovenian: SK-Slovaška Richter Gedeon Nyrt Budapest 10
English: Route of administration
Slovenian: Energieweg 1
English: Av. Baix Llobregat, 3-5 08970 Sant Joan Despi Barcelona - España
Slovenian: Sant Joan Despi 08970
English: 500000 U.I.C/50 ml
Slovenian: 500000 U.I.C / 50 ml raztopina za infundiranje
English: AT - Austria
Slovenian: Avstrija
English: 2 000 000 KUI/200 mL solution for injection intravenous use
Slovenian: 500 000 UIK / 50 mL raztopina za injiciranje intravenska uporaba
English: Trasylol 500 000 KIE
Slovenian: Trasylol 500 000 KIE 10 ku/ml
English: Chemical Works of Gedeon Richter Plc., HU-1103 Budapest, Gyömrői út 19-21., Hungary
Slovenian: Gyömrői út 19-21. 1103 Budapest Madžarska
English: ES - Spain
Slovenian: Španija
English: Bayer Pharma Aktiengesellschaft registered business address: Müllerstr.
Slovenian: DE-Nemčija Bayer Pharma Aktiengesellschaft sedež podjetja:
English: Bayer Schering Pharma AG, Müllerstrasse 170-178, DE13342 Berlin, Germany
Slovenian: DK-Danska Bayer Schering Pharma AG Müllerstrasse 170-178
English: 10.000 K10.000 KIU/ml IU/ml solution for perfusion intravenous use
Slovenian: 10.000 K 10.000 KIU/ml IU/ml raztopina za perfuzijo intravenska uporaba
English: D-13342 Berlin
Slovenian: A-1160 Wien
English: 20 mg Capsule, hard
Slovenian: 20 mg kapsula, trda peroralna uporaba plastenka (HDPE)
English: Oral use bottle (HDPE)
Slovenian: Stična ovojnina
English: Implementation of the agreement by the Member States (submission of the variation by the Marketing Authorisation Holder(s) as applicable):
Slovenian: Izvajanje sporazuma s strani držav članic (predložitev spremembe s strani imetnika (imetnikov) dovoljenja za promet z zdravilom, če je to ustrezno):
English: 23 October 2013
Slovenian: 23. oktober 2013
English: Transmission to National Competent Authorities of the translations of the annexes to the agreement: 19 November 2013
Slovenian: Posredovanje prevodov prilog k sporazumu pristojnim nacionalnim organom:
English: The European Commission issued a decision on 13 December 2010.
Slovenian: Evropska komisija je odločbo izdala dne 13. decembra 2010.
English: 23 September 2010
Slovenian: 23. septembra 2010
English: The usual starting dose is 10 mg once a day.
Slovenian: Običajni začetni odmerek je 10 mg enkrat dnevno.
English: The maximum dose is 80 mg once a day.
Slovenian: Najvišji odmerek je 80 mg enkrat dnevno.
English: Adjustment of dose should be made at intervals of four weeks or more.
Slovenian: Odmerek je treba prilagajati v štiritedenskih ali daljših intervalih.
English: Lipitor is authorised in the EU via national procedures.
Slovenian: Zdravilo Lipitor je bilo v EU odobreno z nacionalnimi postopki.
English: Why was Lipitor reviewed?
Slovenian: Zakaj je bilo zdravilo Lipitor pregledano?
English: The CHMP harmonised the wording for lowering blood lipids as follows:
Slovenian: Odbor CHMP je besedilo za zniževanje lipidov v krvi uskladil na naslednji način:
English: It must not be used in patients with active liver disease or unexplained persistent elevations of serum transaminases (proteins in the blood) exceeding three times the upper limit of normal.
Slovenian: Ne sme se uporabljati pri bolnikih z aktivno boleznijo jeter ali z nepojasnjenim trdovratnim zvišanjem serumskih transaminaz (beljakovin v krvi), ki presega 3-kratno zgornjo normalno mejo.
English: Lipitor is also available in the EU under other trade names: Atorvastatin, Atorvastatina Nostrum, Atorvastatina Parke-Davis, Atorvastatina Pharmacia, Cardyl, Edovin, Liprimar, Orbeos, Prevencor, Sortis, Tahor, Texzor, Torvast, Totalip, Xarator and Zarator.
Slovenian: Zdravilo Lipitor je v EU na voljo tudi pod drugimi tržnimi imeni: Atorvastatin, Atorvastatina Nostrum, Atorvastatina Parke-Davis, Atorvastatina Pharmacia, Cardyl, Edovin, Liprimar, Orbeos, Prevencor, Sortis, Tahor, Texzor, Torvast, Totalip, Xarator in Zarator.
English: The European Medicines Agency has completed a review of Lipitor.
Slovenian: Evropska agencija za zdravila je zaključila pregled zdravila Lipitor.
English: It must also not be used during pregnancy, while breast-feeding and in women of child-bearing potential not using appropriate contraception.
Slovenian: Prav tako se ne sme uporabljati med nosečnostjo, v obdobju dojenja in pri ženskah v rodni dobi, ki ne uporabljajo zanesljive kontracepcijske zaščite.