natgillin/translations-raw huggingface dataset:
• If your doctor has told you that you have PML (progressive multifocal leukoencephalopathy).
• Če vam je zdravnik povedal, da imate PML (progresivno multifokalno levkoencefalopatijo).
PML is a rare infection of the brain.
PML je redka okužba možgan.
• If your doctor tells you that you have a serious problem with your immune system (due to disease for example, leukaemia or HIV or due to a medicine you are taking or have previously taken).
• Če vam je zdravnik povedal, da imate resne težave z vašim imunskim sistemom (na primer zaradi bolezni kot je levkemija, HIV, ali zaradi zdravil, ki jih jemljete ali ste jih jemali).
• If you are taking medicines that cannot be used with TYSABRI (see Using other medicines, below).
• Če jemljete zdravila, ki jih ne morete uporabljati z zdravilom TYSABRI (glejte Uporaba drugih zdravil, spodaj).
• If you have cancer (unless it is a type of skin cancer called basal cell carcinoma).
• Če imate raka (razen v primeru tipa kožnega raka, ki se imenuje bazocelularni karcinom).
• If you are under 18 years of age.
• Če ste stari manj kot 18 let.
Take special care with TYSABRI There have been reports of a rare brain infection called PML (progressive multifocal leukoencephalopathy) that have occurred in patients who have been given TYSABRI.
Bodite posebno pozorni pri uporabi zdravila TYSABRI Poročali so o redki okužbi možganov, imenovani PML (progresivna multifokalna levkoencefalopatija), ki se je pojavila pri bolnikih, zdravljenih z zdravilom TYSABRI.
PML usually leads to severe disability or death.
PML navadno povzroča hudo prizadetost ali smrt.
The symptoms of PML may be similar to an MS relapse (e. g. weakness or visual changes).
Simptomi PML so lahko podobni simptomom recidiva MS (npr. šibkost ali vizualne spremembe).
Therefore, if you believe your MS is getting worse or if you notice any new symptoms, it is very important that you speak to your doctor as soon as possible.
Če imate občutek, da se vaša MS slabša ali opazite nove simptome, je zelo pomembno, da nemudoma govorite z zdravnikom.
Symptoms might arise that you might not become aware of by yourself, such as changes in mood or behaviour, memory lapses, speech and communication difficulties, which your doctor may need to investigate further to rule out PML.
Le- ta lahko opazi simptome, katerih se sami morda ne zavedate, kot so spremembe v razpoloženju ali vedenju, izguba spomina, težave z govorom in komuniciranjem, ki jih mora zdravnik podrobneje raziskati, da izključi PML.
You will also find this information in the Patient Alert Card you have been given by your doctor.
Te informacije najdete tudi v kartici s posebnimi opozorili za bolnika, ki vam jo je dal vaš zdravnik.
Serious infections may occur with TYSABRI.
Pri uporabi zdravila TYSABRI lahko pride do resnih okužb.
If you develop any infection, or if you develop symptoms like an unexplained fever, severe diarrhoea, prolonged dizziness / headache / stiff neck, weight loss, or listlessness, or other symptoms potentially associated with an infection whilst receiving TYSABRI, speak to your doctor as soon as possible and show the Patient Alert Card and this package leaflet to him.
Če med zdravljenjem z zdravilom TYSABRI pride do razvoja okužbe ali pojava simptomov kot so nepojasnjena vročina, huda driska, dolgotrajna omotica / glavobol / trd vrat, izguba telesne mase ali apatičnost ali drugih simptomov, ki so potencialno povezani z okužbo, čim prej govorite z vašim zdravnikom in mu pokažite kartico s posebnimi opozorili in to navodilo za uporabo.
You will also find this information in the Patient Alert Card you have been given by your doctor.
Te informacije boste našli tudi na kartici s posebnimi opozorili, ki ste jo dobili od vašega zdravnika.
It is important that you keep this Alert Card.
Pomembno je, da to kartico s posebnimi opozorili shranite.
Using other medicines Please tell your doctor if you are taking or have recently taken any other medicines, including medicines you may have obtained without a prescription.
Uporaba drugih zdravil Obvestite svojega zdravnika, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta.
You may not be able to use TYSABRI with some medicines that affect your immune system.
Če jemljete zdravila, ki vplivajo na imunski sistem, morda ne boste mogli uporabljati zdravila TYSABRI.
24 Pregnancy and breast-feeding You should not use TYSABRI if you are pregnant unless you have discussed this with your doctor.
Nosečnost in dojenje Ne uporabljajte zdravila TYSABRI, če ste noseči, razen če ste se tako dogovorili s svojim zdravnikom.
Do not breast-feed whilst using TYSABRI.
26 Če uporabljate zdravilo TYSABRI, ne smete dojiti.
Ask your doctor or pharmacist for advice before taking any other medicine with TYSABRI.
Posvetujte se z zdravnikom ali s farmacevtom, preden vzamete katerokoli zdravilo z zdravilom TYSABRI.
Driving and using machines TYSABRI is not expected to have an effect on your ability to drive or to operate machines.
Vpliv na sposobnost upravljanja vozil in strojev Ni pričakovati, da bo zdravilo TYSABRI vplivalo na vašo sposobnost vožnje ali upravljanja s stroji.
If you are concerned, discuss this with your doctor.
Če ste zaskrbljeni, se posvetujte s svojim zdravnikom.
HOW TO USE TYSABRI
KAKO UPORABLJATI ZDRAVILO TYSABRI
TYSABRI will be prepared and given to you by a doctor.
Zdravilo TYSABRI pripravi in da zdravnik.
The adult dose is 300 mg given once every 4 weeks.
Odmerek za odraslo osebo je 300 mg na vsake štiri tedne.
A few patients have had an allergic reaction to TYSABRI.
Nekaj bolnikov je doživelo alergično reakcijo na zdravilo TYSABRI.
Your doctor will check for allergic reactions during the infusion and for 1 hour afterwards.
Zdravnik bo preverjal prisotnost alergične reakcije med infundiranjem in 1 uro po zaključenem dajanju.
This is because patients who received one or two doses of TYSABRI and then had a gap in treatment of three months or more, were more likely to have an allergic reaction when resuming treatment.
Neprekinjeno odmerjanje zdravila TYSABRI je pomembno še posebej prvih nekaj mesecev zdravljenja, zato ker so se pri bolnikih, ki so prejeli enega ali dva odmerka zdravila TYSABRI, nato pa prekinili zdravljenje za tri mesece ali več, pogosteje pojavile alergije, ko so ponovno pričeli z zdravljenjem.
If you miss your dose of TYSABRI If you miss your usual dose of TYSABRI, arrange with your doctor to receive it as soon as you can.
Če ste pozabili uporabiti zdravilo TYSABRI Če ste izpustili običajni odmerek zdravila TYSABRI, se z zdravnikom dogovorite, da ga boste prejeli čim prej.
Like all medicines, TYSABRI can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo TYSABRI neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
If you have any worrying side effects, including any not listed in this leaflet, please tell your doctor, nurse or pharmacist as soon as possible.
Če opazite katerikoli neželeni učinek, vključno s takim, ki ni omenjen v tem navodilu, o tem čim prej obvestite svojega zdravnika, zdravniško osebje ali farmacevta.
25 Speak to your doctor or nurse immediately if you notice any of the following:
Če opazite kaj od spodaj naštetega, se nemudoma pogovorite s svojim zdravnikom ali njegovim osebjem:
Signs of allergy to TYSABRI, during or shortly after your infusion: • Itchy rash (hives) • Swelling of your face, lips or tongue • Difficulty breathing • Chest pain or discomfort • Increase or decrease in your blood pressure (your doctor or nurse will notice this if they are monitoring your blood pressure).
Znaki alergije na zdravilo TYSABRI, ki se pojavijo med ali kmalu po infundiranju: • Srbeč izpuščaj (koprivnica) • Oteklina obraza, ustnic ali jezika • Težave pri dihanju • Bolečine ali nelagodje v prsih • Zvišanje ali znižanje krvnega tlaka (zdravnik ali medicinska sestra bosta to opazila, ko bosta preverjala vaš krvni tlak).
Signs of a possible liver problem: • Yellowing of your skin or the whites of your eyes • Unusual darkening of the urine.
27 Znaki morebitnih težav z jetri: • Porumenelost kože ali beločnice • Nenavadno temen urin.
Side effects are listed below by how commonly they have been reported in clinical trials:
V nadaljevanju so našteti neželeni učinki o katerih so poročali v kliničnih preskušanjih, v padajočem vrstnem redu po pogostosti:
Common side effects that may occur in less than 10 in 100 patients: • Urinary tract infection • Sore throat and runny or blocked up nose • Shivering • Itchy rash (hives) • Headache • Dizziness • Feeling sick (nausea) • Being sick (vomiting) • Joint pain • Fever • Tiredness.
Pogosti neželeni učinki, ki se lahko pojavijo pri manj kot 10 od 100 bolnikov: • Okužbe sečil • Vnetje žrela in zamašen nos ali nosni izcedek • Tresavica • Srbeč izpuščaj (koprivnica) • Glavobol • Omotica • Slabost • Bruhanje • Bolečine v sklepih • Zvišana telesna temperatura • Utrujenost.
Uncommon side effects that may occur in less than 1 in 100 patients: • Severe allergy (hypersensitivity).
Občasni neželeni učinki, ki se lahko pojavijo pri manj kot 1 od 100 bolnikov: • Resna alergija (preobčutljivost).
Rare side effects that may occur in less than 1 in 1000 patients: • Unusual infections (so-called “ Opportunistic infections”) • Progressive multifocal leukoencephalopathy (PML), a rare brain infection.
Redki neželeni učinki, ki se lahko pojavijo pri manj kot 1 od 1. 000 bolnikov: • Neobičajne okužbe (tako imenovane “ oportunistične okužbe ”) • Progresivna multifokalna levkoencefalopatija (PML), redka okužba možganov.
What to do if your MS gets worse or you notice new symptoms There have been reports of a rare brain infection called PML (progressive multifocal leukoencephalopathy) that have occurred in patients who have been given TYSABRI.
Kaj storiti, če se MS poslabša, ali če opazite nove simptome Poročali so o redki okužbi možganov, imenovani PML (progresivna multifokalna levkoencefalopatija), ki se je pojavila pri bolnikih, zdravljenih z zdravilom TYSABRI.
The symptoms of PML may be similar to an MS relapse. • Therefore, if you believe your MS is getting worse or if you notice any new symptoms, it is important that you speak to your doctor as soon as possible. • Discuss your treatment with your partner or caregivers.
Simptomi PML so lahko podobni simptomom recidiva MS. • Če imate občutek, da se vaša MS slabša ali opazite nove simptome, je pomembno, da nemudoma govorite z zdravnikom. • O zdravljenju se pogovorite s svojim partnerjem ali negovalcem.
They might see new symptoms that you might not notice such as changes in mood or behaviour, memory lapses, speech and communication difficulties, which your doctor may need to investigate further to rule out PML. • Show the Alert Card and this package leaflet to any doctor involved with your treatment, not only to your neurologist.
Le- ta lahko opazi simptome, katerih se sami morda ne zavedate, kot so spremembe v razpoloženju ali vedenju, izguba spomina, težave z govorom in komuniciranjem, ki jih mora zdravnik podrobneje raziskati, da izključi PML. • Kartico s posebnimi opozorili in to navodilo za uporabo pokažite vsem zdravnikom, ki sodelujejo v vašem zdravljenju, ne le svojemu nevrologu.
Serious infections may occur with TYSABRI.
Pri zdravljenju z zdravilom TYSABRI se lahko pojavijo hude okužbe.
The symptoms of infections include: − an unexplained fever − severe diarrhoea
Simptomi okužbe vključujejo: nepojasnjeno vročino
26 − shortness of breath − prolonged dizziness − headache − stiff neck − weight loss − listlessness.
• Če mislite, da se je pri vas pojavila okužba, nemudoma govorite z vašim zdravnikom.
• Speak to your doctor as soon as possible if you think you have an infection. • Show the Alert Card and this package leaflet to any doctor involved with your treatment, not only to your neurologist.
28 • Kartico pokažite vsem zdravnikom, ki sodelujejo pri vašem zdravljenju, ne samo vašemu nevrologu.
In a few patients who use TYSABRI, over time the body’ s natural defence may stop TYSABRI from working properly (the body develops antibodies to TYSABRI).
Pri nekaterih bolnikih, ki se zdravijo z zdravilom TYSABRI lahko naravni obrambni mehanizem telesa sčasoma prepreči pravilno delovanje zdravila TYSABRI (telo razvije protitelesa na zdravilo TYSABRI).
HOW TO STORE TYSABRI
SHRANJEVANJE ZDRAVILA TYSABRI
Do not use TYSABRI after the expiry date stated on the label and carton.
Zdravila TYSABRI ne smete uporabljati po izteku roka uporabnosti, ki je naveden na ovojnini in škatli.
Do not use TYSABRI if you notice particles in the liquid and/ or the liquid in the vial is discoloured.
Če v tekočini opazite delce in/ ali če je tekočina v viali obarvana, zdravila TYSABRI ne smete uporabiti.
What TYSABRI contains Each 15 ml vial of concentrate contains 300 mg natalizumab (20 mg/ ml).
Kaj vsebuje zdravilo TYSABRI Vsaka 15 ml viala koncentrata vsebuje 300 mg natalizumaba (20 mg/ ml).
Sodium phosphate, monobasic, monohydrate Sodium phosphate, dibasic, heptahydrate Sodium chloride Polysorbate 80 (E433) Water for injections.
Natrijev dihidrogenfosfat monohidrat Natrijev hidrogenfosfat heptahidrat Natrijev klorid Polisorbat 80 (E433) Voda za injekcije.
What TYSABRI looks like and contents of the pack TYSABRI is a clear, colourless to slightly cloudy liquid.
Izgled zdravila TYSABRI in vsebina pakiranja Zdravilo TYSABRI je bistra, brezbarvna ali rahlo motna tekočina.
27 Marketing Authorisation Holder Elan Pharma International Ltd.
Imetnik dovoljenja za promet z zdravilom Elan Pharma International Ltd.
Manufacturer Biogen Idec B. V.
29 Izdelovalec Biogen Idec B. V.
For any further information about this medicine, please
Za vse morebitne nadaljnje informacije o tem zdravilu dovoljenja za promet z zdravilom.
contact the local representative of the
Informacijo najdete
This information is provided at the end of the leaflet.
se lahko obrnete na predstavništvo imetnika na koncu navodil.
Tél/ Tel: +32 2 219 12 18
Luxembourg/ Luxemburg Biogen Idec Belgium N. V. / S. A Tél/ Tel: +32 2 219 12 18
Przedstawicielstwo w Polsce Tel.: +48 22 642 67 39
S. A Przedstawicielstwo w Polsce Tel.: +48 22 642 67 39
Italia Biogen-Dompé s. r. l.
30 Italia Biogen- Dompé s. r. l.
Use aseptic technique when preparing TYSABRI solution for intravenous (IV) infusion.
Pri pripravi raztopine TYSABRI za intravensko infundiranje uporabite aseptično tehniko.
Remove flip-top from the vial.
Z viale odstranite pokrov „ flip- off “.
Visually inspect the diluted product for particles or discolouration prior to administration.
Pred dajanjem vizualno preverite razredčeno raztopino glede delcev ali obarvanja.
The diluted product is to be used as soon as possible and within 8 hours of dilution.
Raztopino uporabite takoj, ko je mogoče, vendar najpozneje 8 ur po razredčitvi.
If the diluted product is stored at 2°C - 8°C (do not freeze), allow the solution to warm to room temperature prior to infusion.
Raztopina, ki se hrani pri 2 °C – 8 °C (ne zamrzujte), se mora pred infundiranjem segreti na sobno temperaturo.
Any unused product or waste material must be disposed of in accordance with local requirements.
Vse neporabljene proizvode ali odpadni material morate odstraniti v skladu z lokalnimi predpisi.
Tyverb is a medicine containing the active substance lapatinib.
Tyverb je zdravilo, ki vsebuje zdravilno učinkovino lapatinib.
It is available as yellow, oval tablets (250 mg).
Na voljo je v rumenih, ovalnih tabletah (250 mg).
Tyverb is used to treat patients with advanced or metastatic breast cancer which has been shown to be ‘ expressing’ large amounts of ErbB2.
Zdravilo Tyverb se uporablja za zdravljenje bolnikov z napredovalim ali metastatskim rakom dojke s „ prekomerno “ izraženim ErbB2.
This means that the cancer produces (expresses) a specific protein called ErbB2 (also known as HER2) in large quantities on the surface of the tumour cells. ‘ Metastatic’ means that the cancer has spread to other parts of the body.
Beseda „ metastatski “ pomeni, da se je rak že razširil na druge dele telesa.
Tyverb is used in combination with capecitabine (another anticancer medicine).
Zdravilo Tyverb se uporablja v kombinaciji s kapecitabinom (drugim zdravilom proti raku).
It is only used in patients whose disease is getting worse following previous treatment including an anthracycline and a taxane (other types of anticancer medicine), and following treatment of their metastatic disease with trastuzumab (another anticancer medicine).
Zdravilo Tyverb se uporablja samo za zdravljenje bolnikov, pri katerih se je bolezen poslabšala po predhodnem zdravljenju, ki je vključevalo antraciklin in taksan (drugi vrsti zdravil proti raku), ter po zdravljenju metastaz s trastuzumabom (drugim zdravilom proti raku).
Tyverb should only be initiated by a doctor who has experience in giving anticancer medicines.
Zdravljenje z zdravilom Tyverb sme uvesti le zdravnik, ki ima izkušnje z uporabo zdravil proti raku.
The recommended dose of Tyverb is five tablets once a day.
Priporočeni odmerek zdravila Tyverb je pet tablet enkrat na dan.
All five tablets must be taken at the same time, at least one hour before or one hour after food.
Vseh pet tablet je treba vzeti sočasno, najmanj eno uro pred obrokom ali eno uro po obroku.
Each patient should take the medicine at the same time each day with respect to food, such as always before or always after a meal.
Vsak bolnik mora vsak dan zdravilo jemati ob istem času glede na obrok hrane, na primer tako, da ga vedno jemlje pred obrokom ali po obroku.
The doctor may decide to interrupt or stop treatment in patients experiencing certain side effects, especially those affecting the heart, lungs or liver.
Zdravnik se lahko odloči za prekinitev ali ukinitev zdravljenja pri bolnikih, ki imajo določene neželene učinke, zlasti učinke na srce, pljuča ali jetra.
If patients start to take Tyverb again, they may need to use a lower dose.
Če se zdravljenje z zdravilom Tyverb uvede ponovno, je morda potreben manjši odmerek.
Patients who stop taking Tyverb after developing severe liver problems should not start to take the medicine again.
Bolniki, ki prenehajo jemati zdravilo Tyverb, potem ko so se pri njih pojavile hude težave z jetri, zdravila ne smejo začeti ponovno jemati.
Tyverb should be used with caution in patients who have severe kidney problems or moderate to severe liver problems.
Zdravilo Tyverb je treba pri bolnikih, ki imajo hude težave z ledvicami ali zmerne do hude težave z jetri, uporabljati previdno.
These compounds act by blocking types of enzymes known as protein kinases.
Te spojine delujejo tako, da zavirajo vrste encimov, ki jim pravimo proteinske kinaze.
These enzymes can be found in some receptors on the surface of cancer cells, including ErbB2, which is a receptor for epidermal growth factor.
Te encime najdemo v nekaterih receptorjih na površini rakavih celic, med drugim pri ErbB2, ki je receptor za epidermalni rastni faktor.
Reproduction is authorised provided the source is acknowledged. uncontrollably.
Reproduction is authorised provided the source is acknowledged. deljenju.
By blocking these receptors, Tyverb helps to control cell division.
Zdravilo Tyverb z zaviranjem teh receptorjev prispeva k nadzorovanju celične delitve.
About a quarter of breast cancers express ErbB2.
ErbB2 izraža približno četrtina rakov dojke.
The effects of Tyverb were first tested in experimental models before being studied in humans.
Učinki zdravila Tyverb so bili najprej preizkušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
Tyverb was studied in one main study involving 408 women with advanced or metastatic breast cancer that was expressing large quantities of ErbB2.
Zdravilo Tyverb je bilo preučeno v eni glavni študiji, v katero je bilo vključenih 408 žensk z napredovalim ali metastatskim rakom dojke, ki je izražal velike količine ErbB2.
The women had already been treated with anthracyclines, taxanes and trastuzumab but their disease had got worse or come back.
Te ženske so se že zdravile z antraciklini, taksani in trastuzumabom, vendar se je njihova bolezen poslabšala ali ponovila.
The study compared the effectiveness of Tyverb in combination with capecitabine with that of capecitabine alone.
V študiji so primerjali učinkovitost kombinacije zdravila Tyverb in kapecitabina ter samostojne uporabe kapecitabina.
The main measure of effectiveness was the time until the disease got worse, which was assessed in scans about every six weeks.
Glavno merilo učinkovitosti je bil čas do poslabšanja bolezni, ki se je določal s slikanjem približno vsakih šest tednov.
Tyverb in combination with capecitabine was more effective than capecitabine alone.
Kombinacija zdravila Tyverb in kapecitabina je bila učinkovitejša od samostojne uporabe kapecitabina.
On average, as assessed by the patients’ doctors, adding Tyverb increased the time until the disease got worse from 18.3 to 23.9 weeks.
Z dodatkom zdravila Tyverb se je po oceni bolnikovih zdravnikov čas do poslabšanja bolezni v povprečju podaljšal z 18, 3 na 23, 9 tedna.
However, at the time of the medicine’ s assessment, it was difficult to determine within this study whether adding Tyverb had increased the patients’ survival times or not.
Vendar je bilo v času vrednotenja zdravila v tej študiji težko ugotoviti, ali dodatek zdravila Tyverb podaljša čas preživetja bolnikov.
The most common side effects with Tyverb in combination with capecitabine (seen in more than 1 patient in 10) are diarrhoea (which may lead to dehydration), nausea (feeling sick), vomiting, rash, anorexia (loss of appetite), fatigue (tiredness), dyspepsia (indigestion), dry skin, stomatitis (inflammation of the lining of the mouth), constipation, abdominal (tummy) pain, palmar-plantar erythrodysaesthesia (redness and pain on the hands and feet), pain in the extremities (hands and feet), back pain, inflammation of the mucous membranes (moist body surfaces) and insomnia (difficulty sleeping).
Najpogostejši neželeni učinki zdravila Tyverb v kombinaciji s kapecitabinom (opaženi pri več kot 1 bolniku izmed 10) so driska (ki lahko povzroči dehidracijo), navzeja (občutek slabosti), bruhanje, izpuščaj, anoreksija (izguba apetita), utrujenost, dispepsija (prebavne motnje), suha koža, stomatitis (vnetje ustne sluznice), zaprtost, abdominalne (trebušne) bolečine, palmarno- plantarna eritrodisestezija (pordelost in bolečine na dlaneh in stopalih), bolečine v okončinah (rokah in nogah), bolečine v hrbtu, vnetje sluznice (vlažnih površin telesa) in nespečnost (težave s spanjem).
For the full list of all side effects reported with Tyverb, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Tyverb, glejte navodilo za uporabo.
Tyverb should not be used in people who may be hypersensitive (allergic) to lapatinib or any of the other ingredients.
Zdravila Tyverb ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) lapatinib ali katero koli drugo sestavino zdravila.
The Committee for Medicinal Products for Human Use (CHMP) decided that Tyverb’ s benefits are greater than its risks, in combination with capecitabine, for the treatment of patients with advanced or metastatic breast cancer whose tumours overexpress ErbB2 (HER2).
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Tyverb v kombinaciji s kapecitabinom pri zdravljenju napredovalega ali metastatskega raka dojke s prekomerno izraženim ErbB2 (HER2) večje od njim povezanih tveganj.
The Committee recommended that Tyverb be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Tyverb odobri dovoljenje za promet.
Tyverb has been given ‘ Conditional Approval’.
Za zdravilo Tyverb je bila sprejeta „ pogojna odobritev “.
This means that there is more evidence to come about the medicine, in particular its effects on survival and on the spread of breast cancer.
To pomeni, da pričakujemo še več dokazov o zdravilu, zlasti o njegovem učinku na preživetje bolnikov in širjenje raka dojke.
Every year, the European Medicines Agency (EMEA) will review any new information that may have become available and this summary will be updated as necessary.
Evropska agencija za zdravila (EMEA) bo vsako leto pregledala vse razpoložljive nove informacije in po potrebi posodobila ta povzetek.