natgillin/translations-raw huggingface dataset:
Patients who have experienced a hypersensitivity reaction must be permanently discontinued from treatment with TYSABRI. 
Pri bolnikih, ki so doživeli preobčutljivostno reakcijo, je treba zdravljenje z zdravilom TYSABRI
The pharmacokinetics of natalizumab in paediatric MS patients has not been established. 
Farmakokinetika natalizumaba pri otrocih, obolelih za MS, ni bila ugotovljena.
EDSS-baseline, median (range) 
Izhodišče na EDSS, mediana
o TYSABRI increases the risk of developing encephalitis, meningitis and acute retinal necrosis (ARN) caused by herpes simplex and varicella zoster viruses o Guidance on screening for ARN. 
o Zdravilo TYSABRI poveča tveganje za razvoj encefalitisa, meningitisa in akutne retinalne nekroze (ARN), ki jih povzročata virusa herpes simplex in varicella zoster.
In studies conducted in mice, growth and metastasis of melanoma and lymphoblastic leukaemia tumour cells was not increased by the administration of natalizumab. 
Pri študijah na miših dajanje natalizumaba ni vplivalo na rast in zasevke celic tumorja melanoma in limfoblastne levkemije.
Immunosuppressant treatment prior to the use of TYSABRI 
zdravljenje z imunosupresivi pred začetkom uporabe zdravila TYSABRI.
Relapse rate derived variables / MRI-derived variables 
Napredovanje po EDSS Sekundarni opazovani dogodki Iz stopnje recidivov izpeljane spremenljivke/iz MRT-izpeljane spremenljivke
o If treatment is to be continued for longer than 24 months, the need to inform patients about the increased risk of PML and provide them with a copy of the treatment continuation form o Description of Immune Reconstitution Inflammatory Syndrome (IRIS) is provided 
o Če bo zdravljenje trajalo več kot 24 mesecev, je treba bolnike seznaniti s povečanim tveganjem za PML in jim zagotoviti kopijo obrazca za nadaljevanje zdravljenja.
Rate ratio 0.33 CI95% 0.26 ; 0.41 
Razmerje stopnje 0,33 IZ95 % 0,26; 0,41
Cases of JCV GCN have also been reported during postmarketing use of TYSABRI. 
V obdobju trženja zdravila TYSABRI so poročali tudi o primerih JCV GCN.
Concurrent treatment with immunosuppressants 
Sočasno zdravljenje z imunosupresivi
In post marketing experience, serious, life-threatening, and sometimes fatal cases of encephalitis and meningitis caused by herpes simplex or varicella zoster have been reported in multiple sclerosis patients receiving TYSABRI. 
V izkušnjah v obdobju trženja zdravila so pri bolnikih z multiplo sklerozo, zdravljenih z zdravilom TYSABRI, poročali o resnih, življenjsko nevarnih in včasih smrtnih primerih encefalitisa in meningitisa, ki ju povzročajo virusi herpes simplex ali virusi varicella zoster.
• Summary of Product Characteristics and Package Leaflet 
• Povzetek glavnih značilnosti zdravila in Navodilo za uporabo
The active substance is natalizumab. 
Učinkovina je natalizumab.
− differentiation between PML and MS 
− diferenciacija PML in multiple skleroze,
During extended pre-registration trials, two cases of PML were reported in MS patients and a full safety evaluation revealed one further case in a clinical trial patient with Crohn's Disease. 
Razprava o PML pri bolnikih, ki so se zdravili z zdravilom TYSABRI V podaljšanih preskušanjih pred pridobitvijo dovoljenja za promet z zdravilom so poročali o dveh primerih PML pri bolnikih z MS, popolna ocena varnosti pa je razkrila še en primer pri bolniku s
Patients with a treatment history of immunosuppressant medications are at increased risk for PML. 
Predhodno zdravljenje z imunosupresivnimi ali imunomodulatornimi terapijami Pri bolnikih, ki so v preteklosti jemali imunosupresive, je tveganje za PML večje.
Therefore, following PLEX or IA, periodic clinical monitoring of patients, including MRI monitoring, may be useful for the early detection of IRIS. 
PLEX ali IA, bo zato morda koristno redno klinično spremljanje bolnikov, vključno s slikanjem z magnetno resonanco.
• Reminder to show the card to any doctor involved with their treatment 
Opozorilna kartica za bolnika • Navodilo, da je treba kartico pokazati vsem zdravnikom, ki so vključeni v zdravljenje.
• Add the 15 ml concentrate for solution for infusion to 100 ml sodium chloride 9 mg/ml (0.9%) solution for injection. 
• 15 ml koncentrata za raztopino za infundiranje dodajte 100 ml natrijevega klorida 9 mg/ml (0,9 %) raztopine za injiciranje.
Within 3 months prior to starting TYSABRI Annually during treatment with TYSABRI More frequent MRIs (e.g. on a 3 to 6 monthly basis) for patients at high risk for PML. 
enkrat letno med zdravljenjem z zdravilom TYSABRI, pogostejša MRS (npr. vsake 3 do 6 mesecev) za bolnike z velikim tveganjem za PML, ob prvih znakih kakršnih koli simptomov, ki kažejo na možnost pojava PML.
Diluted solution: 
Razredčena raztopina:
Some cases have occurred in patients with central nervous system (CNS) herpes infections (e.g. herpes meningitis and encephalitis). 
Nekateri primeri so se pojavili pri bolnikih z okužbami osrednjega živčnega sistema s herpesom
Diluted solution After dilution with sodium chloride 9 mg/ml (0.9%) solution for injection, immediate use is recommended. 
Priporoča se, da z natrijevim kloridom 9 mg/ml (0,9 %) raztopino za injiciranje razredčeno raztopino takoj uporabite.
• Patients with a high anti-JCV antibody index who have received more than 2 years of 
• Bolnike z visokim indeksom protiteles proti JCV, ki so se z zdravilom TYSABRI
The reactions are reported as MedDRA preferred terms under the MedDRA primary system organ class. 
Neželeni učinki so navedeni z izrazi, ki jih priporoča MedDRA, in glede na MedDRA organske sisteme.
• Reminder of the approved dosing; cross reference to EU SmPC 
Informacije o podaljšanem intervalu odmerjanja (PIO) • Opomnik glede odobrenega odmerka; navzkrižno sklicevanje na EU povzetek glavnih značilnosti zdravila.
Persistent anti-natalizumab antibodies (one positive test reproducible on retesting at least 
Pri približno 6 % bolnikov so se razvila obstojna proti-natalizumabna protitelesa (en pozitivni test, potrjen pri ponovnem testiranju vsaj 6 tednov kasneje).
Serious adverse events were evaluated in 621 MS paediatric patients included in a meta-analysis (see also Section 5.1). 
Pediatrična populacija Pri 621 pediatričnih bolnikih z MS, vključenih v metaanalizo, so ocenjevali resne neželene učinke
Contents of the pack and other information 
Shranjevanje zdravila TYSABRI Vsebina pakiranja in dodatne informacije
and IRIS 
Zaradi reakcije IRIS
Presence of anti-JC virus antibodies Level of the antibody response (index) for patients without a history of immunosuppressant treatment 
Drugi dejavniki, povezani s povečanim tveganjem za razvoj PML: prisotnost protiteles proti JCV, raven odziva protiteles (indeks) za bolnike brez zdravljenja z imunopresivi v anamnezi,
Therefore the physician must confirm that such patients are not immunocompromised before starting treatment with TYSABRI (see also section 
Zdravnik mora potrditi ustrezno odpornost pri bolnikih, preden začnejo zdravljenje z zdravilom TYSABRI (glejte tudi poglavje 4.4).
This includes: 
UPORABNO DO:
Spontaneous serious adverse reactions of liver injury have been reported during the post marketing phase. 
V obdobju trženja zdravila so poročali o spontanih hudih neželenih reakcijah okvare jeter.
TYSABRI contains sodium 
Zdravilo TYSABRI vsebuje natrij.
- Keep this leaflet and the Patient Alert Card. You may need to read them again. 
- Navodilo in opozorilno kartico za bolnika shranite.
virus granule cell neuronopathy) is also caused by JC virus and has occurred in some patients who have been given TYSABRI. 
Virus JC lahko povzroči tudi bolezen, imenovano JCV GCN (JCV nevropatija zrnatih celic), o kateri so poročali pri nekaterih bolnikih, zdravljenih z zdravilom TYSABRI.
• Reminder to read the package leaflet carefully before starting Tysabri 
• Navodilo, da je treba pred začetkom jemanja zdravila Tysabri skrbno prebrati navodilo za uporabo.
Patients who have all three risk factors for PML (i.e., are anti-JCV antibody positive and have received more than 2 years of TYSABRI therapy, and have received prior immunosuppressant therapy) have a higher risk of PML. 
Pri bolnikih z vsemi tremi dejavniki tveganja za PML (tj. so pozitivni na protitelesa proti JCV, so se več kot dve leti zdravili z zdravilom TYSABRI in so jih predhodno zdravili z imunosupresivi) obstaja večje tveganje za razvoj PML.
Efficacy as monotherapy has been evaluated in one randomised, double-blind, placebo-controlled study lasting 2 years (AFFIRM study) in relapsing-remitting MS patients who had experienced at least 1 clinical relapse during the year prior to entry and had a Kurtzke Expanded Disability Status Scale (EDSS) score between 0 and 5. 
1 leto pred vključitvijo vsaj en klinični recidiv in po lestvici prizadetosti EDSS (Kurtzke Expanded Disability Status Scale) med 0 in 5 točkami.
After the infusion is complete, flush the intravenous line with sodium chloride 9 mg/ml (0.9%) solution for injection. 
Po končanem infundiranju sperite intravensko linijo z natrijevim kloridom 9 mg/ml (0,9 %)
• Prescriber name, signature and date 
• ime, podpis zdravnika, ki predpisuje zdravilo, in datum.
Patients who have all three risk factors for PML (i.e., are anti-JCV antibody positive and have received more than 2 years of TYSABRI therapy, and have received prior immunosuppressant therapy) have a significantly higher risk of PML. 
PML (tj. so pozitivni na protitelesa proti JCV in so se z zdravilom TYSABRI zdravili več kot 2 leti in so pred tem prejemali imunosupresive), je tveganje za PML značilno večje.
o Management of PML o Monitoring strategy after discontinuation of TYSABRI treatment o The need to inform patients about the benefits and risk of TYSABRI and provide them with: 
o Bolnike je treba seznaniti s koristmi in tveganji zdravila TYSABRI ter jim posredovati naslednje:
o That the risk of PML increases with increasing duration of treatment and that treatment beyond 24 months carries additional risk and other factors associated with an increased risk for the development of PML 
o Tveganje PML narašča s trajanjem zdravljenja in zdravljenje, ki traja dlje kot
Talk to your doctor before using TYSABRI. 
Pred začetkom uporabe zdravila TYSABRI se posvetujte z zdravnikom.
Caution regarding potential concomitant immune effects is required when switching patients from teriflunomide to TYSABRI. 
Pri prehajanju bolnikov s teriflunomida na zdravilo TYSABRI je potrebna previdnost glede možnih sočasnih imunskih učinkov.
Over the 2-year duration of the studies, 43.5% of patients treated with natalizumab reported adverse reactions (placebo: 39.6%). 
43,5 % bolnikov, zdravljenih z natalizumabom, poročalo o neželenih učinkih zdravila
• Keep alert card with the them after discontinuation • Reporting of side effects 
• Po prekinitvi zdravljenja morajo imeti pri sebi opozorilno kartico.
• Yellowing of your skin or the whites of your eyes • Unusual darkening of the urine. 
• porumenelost kože ali beločnice
In anti-JCV antibody positive TYSABRI treated patients who have not used prior immunosuppressants the level of anti-JCV antibody response (index) is associated with the level of risk for PML (i.e. the risk is greater in those with a high antibody index compared to those with a low index). 
JCV (indeks) povezana s stopnjo tveganja za razvoj PML (tako je tveganje večje pri bolnikih z visokim indeksom protiteles v primerjavi z bolniki z nizkim indeksom).
Your doctor may switch you directly from another medicine for MS to TYSABRI if there are no signs of abnormalities caused by your previous treatment. 
Če ni nobenih bolezenskih znakov, ki bi jih povzročilo vaše predhodno zdravljenje, vam lahko zdravnik drugo zdravilo za MS neposredno zamenja z zdravilom TYSABRI.
Hepatic events 
Farmakodinamični učinki
Discussion of PML in TYSABRI Treated Patients 
V opazovalnih študijah v obdobju trženja zdravila so pri bolnikih, zdravljenih z zdravilom Tysabri,
Speak to your doctor or nurse immediately if you notice any of the following Symptoms of serious infections including: 
Če opazite kar koli od naslednjega, se takoj posvetujte z zdravnikom ali medicinsko sestro.
The interim analysis showed a lower risk of PML in patients treated with EID (hazard ratio = 0.06 95% CI of hazard ratio = 0.01- 0.22). 
PIO (razmerje tveganja= 0,06; 95-% IZ razmerja tveganja = 0,01-0,22).
In 2-year controlled clinical trials in MS patients, the rate of infection was approximately 1.5 per patient-year in both natalizumab- and placebo-treated patients. 
1,5 na bolnika-leto, tako pri bolnikih zdravljenih z natalizumabom, kot pri bolnikih, zdravljenih s placebom.
1 ≥106.3 and ≤ 108.3 CFU of live Bordetella bronchiseptica bacteria strain B-C2 per dose 
≥ 106,3- ≤ 108,3 CFU živih bakterij Bordetella bronchiseptica, sev B-C2, na odmerek
Vial (type I glass) in plastic box 
Viala (steklo tip I) In plastična škatla
Vial (type I glass) in carton box 
Viala (steklo tip I) in zloženka
Pack size l t o r 
Farmacevtska oblika Pot uporabe Stična ovojnina Velikost pakiranja o č
Invented nameStrength Pharmaceutical Form 
Izmišljeno ime Jakost
The results of these pre-specified analyses are as follows: 
Rezultati teh vnaprej določenih analiz so naslednji:
• you are pregnant. 
• če ste noseči.
Summarised below are PFS results: 
Spodaj so povzeti rezultati PFS:
• epidemiological studies/non-interventional or observational studies, 
• v epidemioloških študijah/neinterventnih ali opazovalnih študijah ali,
Currently available data are described in sections 4.8, 5.1 and 5.2, but no recommendation on a posology can be made. 
Trenutno razpoložljivi podatki so opisani v poglavjih 4.8, 5.1 in 5.2, vendar priporočil o odmerjanju ni mogoče dati.
Overall survival (final analysis)*** 
Celokupno preživetje (končna analiza)***
Observed in paediatric population only. 
Opaženo samo pri pediatrični populaciji.
Interferon alfa-2a 9 MIU 3x/week. 
a interferon alfa-2a 9 mio 3x/teden.
• spontaneous reporting, 
• pri spontanem poročanju,
Further details on the study and the results are provided below. 
Dodatne podrobnosti o preskušanju in rezultati so navedeni spodaj.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 15 January 2018 
Datum prve odobritve: 15. januar 2018
Blinded independent review (protocol-defined primary analysis). 
Slepi neodvisni pregled (primarna analiza, določena s protokolom).
• loss of appetite, 
• izgubo apetita,
• abnormal urine test (protein in the urine), 
• nenormalen urinski test (beljakovine v seču),
Patients older than 65 years have an increased risk of experiencing the following side effects: 
Pri bolnikih, starejših od 65 let, je večje tveganje za naslednje neželene učinke:
• or through an evaluation of individual case reports. 
• s presojo poročil posameznih primerov.
** Primary analysis at clinical cut-off 31 January 2006. 
** Primarna analiza kliničnih podatkov zbranih do 31. januarja 2006.
MVASI may also cause changes in laboratory tests carried out by your doctor. 
Zdravilo MVASI lahko povzroči tudi spremembe rezultatov laboratorijskih testov, ki jih izvaja vaš zdravnik.
Terms represent a group of events that describe a medical concept rather than a single condition or MedDRA (Medical Dictionary for Regulatory Activities) preferred term. 
Termini predstavljajo skupino neželenih učinkov, ki opisujejo medicinski pojem namesto posameznega stanja ali prednostni izraz po MedDRA (Medical Dictionary for Regulatory Activites).
• your doctor will decide when you should be given your next dose of MVASI. 
• bo vaš zdravnik odločil o tem, kdaj boste prejeli naslednji odmerek tega zdravila.
• lack of energy, 
• pomanjkanje energije,
Elderly patients: No dose adjustment is required in the elderly. 
Starejši bolniki: za starejše bolnike prilagajanje odmerka ni potrebno.
• any severe bleeding. 
• kakršna koli huda krvavitev.
Subject to a p-value boundary of 0.0116. 
Odvisna od meje p-vrednosti, ki je 0,0116.
• you may develop a severe migraine. 
• lahko dobite hudo migreno.
*** The final analysis of overall survival was performed when 266 deaths, which account for 73.7% of enrolled patients, were observed. 
*** Končna analiza celokupnega preživetja je bila opravljena, ko je nastopilo 266 smrti, kar je predstavljalo 73,7 % vključenih bolnic.
Kaplan-Meier estimates. 
Ocena po metodi Kaplan-Meier.
• post-authorisation safety studies, 
• v varnostnih študijah po pridobitvi dovoljenja za promet,
Please consult your doctor if you or your family tend to suffer from bleeding problems or you are taking medicines to thin the blood for any reason. 
Posvetujte se s svojim zdravnikom, če ste vi ali vaša družina nagnjeni k težavam zaradi krvavitev ali če jemljete zdravila za redčenje krvi iz kakršnih koli razlogov.
Based on a substudy from NSABP C-08 with 295 patients. 
Na podlagi podštudije NSABP C-08 z 295 bolnicami.
Severe side effects of unknown frequency (frequency cannot be estimated from the available data), include: 
Hudi neželeni učinki z neznano pogostnostjo (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti), vključujejo:
However two of the randomised patients discontinued the study before receiving any study treatment. 
Dva izmed randomiziranih bolnikov sta bila iz študije izključena, preden sta prejela katero koli zdravljenje, uporabljeno v študiji.
• if you undergo surgery. 
• če boste operirani.
Tumour assessments and response evaluations were determined by the investigators using the GOG RECIST criteria (Revised RECIST guideline (version 1.1). 
Ocene tumorjev in vrednotenje odzivov so določili raziskovalci z uporabo kriterijev GOG RECIST (revidiranih smernic RECIST (verzija 1.1).
• problems with the eyes (including increased production of tears), 
• težave z očmi (vključno s povečanim solzenjem),
Final analysis 
Končna analiza.
Name and address of the manufacturer of the biological active substance Amgen Inc 
Ime in naslov izdelovalca biološke učinkovine Amgen Inc
• abnormally high blood pressure in the blood vessels of the lungs which makes the right side of the heart work harder than normal, 
• nenormalno visok krvni tlak v krvnih žilah pljuč, zaradi česar mora desna stran srca delati močneje kot navadno,
Approximate 95% CI for difference of two rates using Hauck-Anderson method. 
Približni 95-% interval zaupanja za razliko dveh deležev z uporabo Hauck-Andersonove metode.
MVASI use is not recommended in children and adolescents under the age of 18 years because the safety and benefit have not been established in these patient populations. 
Uporaba zdravila MVASI ni priporočena pri otrocih in mladostnikih, mlajših od 18 let, ker varnosti in koristi zdravila pri tej populaciji niso dokazali.
Please discuss with your doctor if you noticed this previously. 
Pogovorite se s svojim zdravnikom, če ste to že kdaj opazili.
The adverse reactions listed in this section fall into the following frequency categories: Very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the available data). 
V tem poglavju so neželeni učinki navedeni po pogostnosti na naslednji način: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000), ni znano (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov).
With or without gross residual disease. 
Z ali brez preostanka bolezni.
Do not stop treatment with MVASI unless you have discussed this with your doctor. 
Ne prenehajte zdravljenja z zdravilom MVASI, ne da bi se o tem pogovorili s svojim zdravnikom.
There is insufficient information to determine the safety and efficacy of bevacizumab in children with newly diagnosed high-grade glioma. 
Na voljo ni dovolj podatkov, da bi določili varnost in učinkovitost bevacizumaba pri otrocih z novo diagnosticiranim gliomom visoke stopnje malignosti.
The incidence varied between 10% (4/40) and 20% 
Incidenca se je gibala med 10 % (4/40) in 20 % (3/15).
p-value (Chi-squared test) 
Vrednost p (test hi-kvadrat)
Before initiating MVASI, this risk should be carefully considered in patients with risk factors such as hypertension or history of aneurysm. 
Pred uvedbo zdravila MVASI je treba to tveganje skrbno preučiti pri bolnikih z dejavniki tveganja, kot sta hipertenzija ali anamneza anevrizme.
There are no clinical trial data on the use of bevacizumab in pregnant women. 
Iz kliničnih preskušanj ni podatkov o uporabi bevacizumaba pri nosečnicah.
It rarely resulted in discontinuation of bevacizumab treatment or hospitalisation. 
Redko je prišlo do prekinitve zdravljenja z bevacizumabom ali hospitalizacije.
• Bleeding in the eye. 
• krvavitev v očesu.
After cycle 1, the medicinal product could be delivered as a 1-hour infusion. 
Po prvem ciklusu se lahko zdravilo daje kot 1-urna infuzija.
Please talk to your doctor since blood clots can lead to heart attack and stroke. 
Posvetujte se s svojim zdravnikom, saj lahko krvni strdki privedejo do srčnega napada in kapi.
MVASI has not been shown to reduce your ability to drive or to use any tools or machines. 
Za zdravilo MVASI se ni izkazalo, da bi zmanjšalo vašo sposobnost za vožnjo ali uporabo orodij oziroma strojev.
EU/1/17/1246/002 
EU/1/17/1246/001 EU/1/17/1246/002
It is important that your doctor knows if you have ever received anthracyclines (for example doxorubicin, a specific type of chemotherapy used to treat some cancers) or had radiotherapy to your chest, or if you have heart disease. 
Pomembno je, da vaš zdravnik ve, če ste kdaj prejeli antracikline (na primer doksorubicin, specifično vrsto kemoterapije, ki jo uporabljajo pri zdravljenju nekaterih vrst raka), če so vam obsevali prsni koš ali če imate srčno bolezen.
When bevacizumab is injected directly into the eye (unapproved use), the following side effects may occur: 
Kadar bevacizumab injiciramo neposredno v oko (neodobrena uporaba), se lahko pojavijo naslednji neželeni učinki:
Please discuss this with your doctor if you have metastatic cancer affecting your brain. 
Posvetujte se s svojim zdravnikom, če imate rak v metastatski obliki, ki je prizadel vaše možgane.
Bevacizumab has no or negligible influence on the ability to drive and use machines. 
Bevacizumab nima oziroma ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
• blood clot in the arteries which can lead to a stroke or a heart attack, 
• krvni strdki v arterijah, ki lahko vodijo do kapi ali srčnega napada,
Key efficacy results for the superiority analysis (ITT population, trial NO16966) 
Ključni rezultati učinkovitosti za analizo superiornosti (populacija, ki so jo nameravali zdraviti; preskušanje NO16966)
The safety and efficacy of concomitant administration of radiotherapy and bevacizumab has not been established. 
Varnost in učinkovitost sočasnega zdravljenja z radioterapijo in bevacizumabom nista bili ugotovljeni.
Duration of response Median time (months) 
Trajanje odgovora Mediana časa (meseci)
For additional information refer below within section “Description of selected serious adverse reactions”. 
Za nadaljnje informacije glejte spodnje podpoglavje ”Opis določenih resnih neželenih učinkov”.
Patients included in analysis 
Število bolnikov, vključenih v analizo delež
Follow-up analysis was performed with a data cut-off date of 07 March 2014; all p-values are displayed for descriptive purpose only. 
Analizo po spremljanju so opravili s podatki, zajetimi do 7. marca 2014; vse vrednosti p so napisane samo za deskriptivne namene.
• The risk of developing blood clots in your arteries (a type of blood vessel) can increase if you are over 65 years old, if you have diabetes, or if you have had previous blood clots in your arteries. 
• tveganje za pojav krvnih strdkov v arterijah (tip krvne žile) je lahko povečano, če ste starejši od 65 let, imate sladkorno bolezen ali če ste v preteklosti že imeli krvne strdke v arterijah.
The median age of patients was 61.0 (range: 25-84) years. 
Mediana starosti bolnic je bila 61,0 let (razpon: 25 do 84 let).
These clinically significant reactions have therefore been included in table 2 within the column entitled “Frequency not known”. 
Te klinično pomembne neželene učinke so zato v preglednici 2 razvrstili v kolono »Neznana pogostnost«.