natgillin/translations-raw huggingface dataset:
The company that makes Bronchitol must ensure that all healthcare professionals expected to prescribe the medicine are provided with important safety information including information on the risk of narrowing of the airways in the lungs and the coughing of blood and how to manage this risk. 
Družba, ki izdeluje zdravilo Bronchitol, mora zagotoviti, da so vsi zdravniki, za katere se pričakuje, da bodo zdravilo predpisovali, seznanjeni s pomembnimi informacijami o varnosti, vključno z informacijami o tveganju za zožitev dihalnih poti v pljučih in izkašljevanje krvi ter o načinih obvladovanja teh tveganj.
The summary of the opinion of the Committee for Orphan Medicinal Products for Bronchitol can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designations. 
Povzetek mnenja Odbora za zdravila sirote za zdravilo Bronchitol je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designations.
It is available as capsules (40 mg) containing a dry powder for inhalation using an inhaler device. 
Na voljo je v obliki kapsul (40 mg), ki vsebujejo suh prašek za vdihavanje z inhalatorjem.
Bronchitol was tested in two main studies involving 642 patients between six and 56 years of age with mild or moderate cystic fibrosis. 
Bronchitol so preskusili v dveh glavnih študijah, ki sta vključevali 642 bolnikov, starih od 6 do 56 let, z blago ali zmerno cistično fibrozo.
What measures are being taken to ensure the safe use of Bronchitol? 
Kateri ukrepi se izvajajo za zagotovitev varne uporabe zdravila Bronchitol?
In both studies the patients received either 400 mg of inhaled Bronchitol twice daily or 50 mg of inhaled Bronchitol twice daily (which was considered ineffective and hence intended as placebo (dummy treatment)). 
V obeh študijah so bolniki prejemali bodisi 400 mg vdihanega zdravila Bronchitol dvakrat dnevno bodisi 50 mg vdihanega zdravila Bronchitol dvakrat dnevno (kar naj bi bilo neučinkovito in zato mišljeno kot uporaba placeba (zdravilo brez zdravilne učinkovine)).
EPAR summary for the public 
Povzetek EPAR za javnost manitol
The most common side effect with Bronchitol (seen in more than 1 patient in 10) is cough. 
Najpogostejši neželeni učinek zdravila Bronchitol (opažen pri več kot 1 bolnikih od 10) je kašelj.
Regarding the safety of Bronchitol, the CHMP considered that sufficient measures have been proposed by the company to reduce the risks of bronchospasm and haemoptysis. 
Kar zadeva varnost zdravila Bronchitol, je Odbor menil, da je družba predlagala zadostne ukrepe za zmanjšanje tveganja za pojav bronhospazma in hemoptize.
This first dose of 400 mg Bronchitol should only be given under the supervision of a qualified healthcare professional in a setting where the patient's breathing can be properly monitored and facilities for resuscitation are available. 
Ta prvi, 400-miligramski, odmerek zdravila Bronchitol se lahko daje samo pod nadzorom usposobljenega zdravstvenega delavca v okoliščinah, v katerih je mogoče ustrezno spremljati bolnikovo dihanje in kjer je na voljo oprema za oživljanje.
Because the number of patients with cystic fibrosis is low, the disease is considered ‘rare', and Bronchitol was designated an ‘orphan medicine' (a medicine used in rare diseases) on 7 November 
Ker je število bolnikov s cistično fibrozo malo, velja ta bolezen za redko, zato je bilo zdravilo Bronchitol dne 7. novembra 2005 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni).
The exact way in which Bronchitol works in cystic fibrosis is not known. 
Natančen način delovanja zdravila Bronchitol pri cistični fibrozi še ni razjasnjen.
The full EPAR for Bronchitol can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports. 
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Bronchitol je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
What benefit has Bronchitol shown during the studies? 
Kakšne koristi je zdravilo Bronchitol izkazalo med študijami?
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Bronchitol. 
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Bronchitol, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
Bronchitol is used for the treatment of cystic fibrosis in adults in addition to best standard of care. 
Zdravilo Bronchitol se uporablja za zdravljenje cistične fibroze pri odraslih v kombinaciji z najboljšim standardom oskrbe.
This leads to problems with the digestion and absorption of food, resulting in poor growth, and long-term infection and inflammation of the lungs because of excess mucus not being cleared away. 
To povzroči težave s prebavo in absorpcijo hrane ter posledično počasnejšo rast, v pljučih pa se razvijeta dolgotrajna okužba in vnetje zaradi odvečne sluzi, ki se ne odvaja.
Cystic fibrosis is an inherited disease that affects the cells in the lungs and the glands in the gut and pancreas that secrete fluids such as mucus and digestive juices. 
Cistična fibroza je dedna bolezen, ki prizadene celice v pljučih ter žleze v črevesju in trebušni slinavki, ki izločajo tekočine, kot so sluz in prebavni sokovi.
The active substance in Bronchitol, mannitol, is a naturally occurring polyol (a sugar alcohol) that is widely used as an osmotic agent. 
Zdravilna učinkovina v zdravilu Bronchitol, manitol, je naraven poliol (sladkorni alkohol), ki se pogosto uporablja kot osmozno sredstvo.
Bronchitol must not be used in people who are hypersensitive (allergic) to mannitol. 
Zdravila Bronchitol ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) manitol.
The most serious side effect with Bronchitol is bronchospasm (narrowing of the airways of the lung) during the initiation dose assessment and haemoptysis (coughing of blood) during treatment with Bronchitol. 
Najresnejša neželena učinka sta bronhospazem (zožitev dihalnih poti v pljučih) med ocenjevanjem začetnega odmerka in hemoptiza (izkašljevanje krvi) med zdravljenjem z zdravilom Bronchitol.
The main measure of effectiveness was based on the improvement in patients' forced expiratory volume in one second (FEV1) adjusted for the patients age, height and sex, measured over 26 weeks in both studies. 
Glavno merilo učinkovitosti je temeljilo na izboljšanju bolnikovega forsiranega ekspiracijskega volumna v eni sekundi (FEV1), prilagojenega bolnikovi starosti, višini in spolu.
Bronchitol is a medicine that contains the active substance mannitol. 
Bronchitol je zdravilo, ki vsebuje zdravilno učinkovino manitol.
Patients who show bronchial hyperresponsiveness must not be treated with Bronchitol. 
Bolniki, pri katerih nastopi bronhialna preodzivnost, se ne smejo zdraviti z zdravilom Bronchitol.
Before initiating treatment with Bronchitol, patients need to undergo an initiation dose assessment during which they are challenged with an increasing dose of Bronchitol up to 400 mg in total to detect bronchial hyperresponsiveness (a state in which the airways of the lungs narrow easily). 
Pred začetkom zdravljenja z zdravilom Bronchitol je treba presoditi, kakšen začetni odmerek je ustrezen; bolnikom se dajejo naraščajoči odmerki zdravila Bronchitol (do skupaj 400 mg), da se odkrije bronhialna preodzivnost (stanje, v katerem se pljučne dihalne poti zlahka zožijo).
After being inhaled, Bronchitol is believed to cause the inflow of fluid into the airway secretions in the lungs, making them less viscous and therefore easier to be cleared away. 
Zdravilo Bronchitol po vdihavanju domnevno povzroči pritok tekočine v izločke pljučnih dihalnih poti, zaradi česar postanejo manj viskozni in se lažje odstranijo.
The Committee took the view that although the improvement in FEV1 shown by the studies was small Bronchitol may be of benefit in patients with cystic fibrosis if used in addition to best standard of care. 
Čeprav je iz študij razvidno, da je izboljšanje FEV1 majhno, je odbor CHMP menil, da lahko zdravilo Bronchitol koristi bolnikom s cistično fibrozo, če se uporablja poleg najboljšega standarda oskrbe.
What is the risk associated with Bronchitol? 
Kakšna tveganja so povezana z zdravilom Bronchitol?
The CHMP therefore concluded that the benefits of Bronchitol in addition to best standard of care outweigh its risks for adult patients with cystic fibrosis and recommended that it be granted marketing authorisation. 
Zato je zaključil, da koristi uporabe zdravila Bronchitol v kombinaciji z najboljšim standardom oskrbe odtehtajo tveganja pri odraslih bolnikih s cistično fibrozo, in priporočil, da se zanj odobri dovoljenje za promet.
For more information on how to use Bronchitol, see the instructions in the package leaflet. 
Za več informacij o uporabi zdravila Bronchitol glejte navodilo za uporabo.
For the full list of all side effects reported with Bronchitol, see the package leaflet. 
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Bronchitol, glejte navodilo za uporabo.
Why has Bronchitol been approved? 
Zakaj je bilo zdravilo Bronchitol odobreno?
Patients overall showed an improvement of approximately 2-3% in FEV1 adjusted for age, height and sex when compared with placebo over 26 weeks of treatment with Bronchitol. 
Pri bolnikih v splošnem se je po 26 tednih zdravljenja z zdravilom Bronchitol pokazalo izboljšanje FEV1 za približno 2-3 %, prilagojenega njihovi starosti, višini in spolu, v primerjavi s placebom.
In cystic fibrosis these fluids become thick and viscous, blocking the airways and the flow of digestive juices. 
Pri bolnikih s cistično fibrozo te tekočine postanejo goste in viskozne ter ovirajo dihalne poti in pretok prebavnih sokov.
Bronchitol is inhaled using the inhaler device provided. 
Zdravilo Bronchitol se vdihava z uporabo priloženega inhalatorja.
Bronchitol must also not be used in patients with bronchial hyperresponsiveness. 
Uporabljati ga ne smejo tudi bolniki z bronhialno preodzivnostjo.
How has Bronchitol been studied? 
Kako je bilo zdravilo Bronchitol raziskano?
What is Bronchitol used for? 
Za kaj se zdravilo Bronchitol uporablja?
What is Bronchitol? 
Kaj je zdravilo Bronchitol?
How does Bronchitol work? 
Kako zdravilo Bronchitol deluje?
How is Bronchitol used? 
Kako se zdravilo Bronchitol uporablja?
The vaccine has been authorised under ‘exceptional circumstances'. 
Cepivo je bilo odobreno v „izjemnih okoliščinah“.
Dosing recommendations are only available for adults. 
Priporočila glede odmerkov so na voljo samo za odrasle.
The virus has first been inactivated so that it does not cause any disease. 
Virus je bil najprej inaktiviran, tako da ne povzroča bolezni.
The vaccine should be given according to official recommendations. 
Cepivo je treba uporabljati v skladu z uradnimi priporočili.
The full EPAR for Pumarix can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports. 
Celotno evropsko javno poročilo o oceni zdravila je na voljo na spletni strani agencije ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
The European Commission granted a marketing authorisation valid throughout the European Union for Pumarix to GlaxoSmithKline Biologicals s.a. on 4 March 2011. 
Evropska komisija je dovoljenje za promet s cepivom Pumarix, veljavno po vsej Evropski uniji, odobrila družbi GlaxoSmithKline Biologicals s.a. dne 4. marca 2011.
It contains parts of influenza (flu) viruses that have been inactivated (killed). 
Vsebuje dele virusov influence (gripe), ki so bili inaktivirani (uničeni).
The effects of Pumarix were first tested in experimental models before being studied in humans. 
Učinki zdravila Pumarix so bili najprej preskušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
It should only be used once a flu pandemic has been officially declared by the World Health Organization (WHO) or European Union (EU). 
Uporablja se lahko šele potem, ko Svetovna zdravstvena organizacija (WHO) ali Evropska unija (EU) uradno razglasi pandemijo gripe.
Adults should be given a dose of 0.5 ml followed by a second dose after an interval of at least three weeks. 
Odrasli naj prejmejo 0,5-mililitrski odmerek, ki mu v razmiku treh tednov sledi drugi odmerek.
This will help to protect against the disease caused by the virus. 
Ta mu bodo pomagala pri obrambi pred boleznijo, ki jo ta virus povzroča.
For more information about treatment with Pumarix, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Pumarix preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte s svojim zdravnikom ali farmacevtom.
The CHMP decided that the vaccine's benefits are greater than its risks and recommended that it be given marketing authorisation. 
CHMP je sklenil, da so koristi cepiva večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
The vaccine contains a flu strain called ‘A/Indonesia/05/2005 PR8-IBCDCRG2' (H5N1). 
Cepivo vsebuje sev gripe, imenovan ‘A/Indonesia/05/2005 PR8-IBCDC-RG2' (H5N1).
This is a summary of the European public assessment report (EPAR) for Pumarix. 
Ta dokument je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Pumarix.
Before a pandemic starts, nobody knows which strain of flu virus will be involved, so pharmaceutical companies cannot prepare the correct vaccine in advance. 
Pred začetkom pandemije ni znano, kateri sev virusa gripe se bo razvil, zato farmacevtska podjetja ne morejo vnaprej pripraviti ustreznega cepiva.
Instead, they can prepare a vaccine that contains a strain of flu virus specifically chosen because very few people have been exposed to it, and to which very few people are immune. 
Lahko pa pripravijo cepivo, ki vsebuje posebej izbrani sev virusa gripe, ki mu je bilo izpostavljenih zelo malo ljudi in proti kateremu je imunih zelo malo ljudi.
The main measure of effectiveness in both studies was the ability to trigger the production of antibodies against the flu virus (‘immunogenicity') after six weeks. 
Glavno merilo učinkovitosti v obeh študijah je bila sposobnost cepiva, da sproži nastajanje protiteles (imunogenost) proti virusu gripe po šestih tednih.
When the company that makes the vaccine includes in it the flu strain responsible for a pandemic, it will collect information on the safety and effectiveness of the final pandemic vaccine, and submit this to the CHMP for evaluation. 
Ko bo družba, ki izdeluje cepivo, vanj vključila sev gripe, odgovoren za pandemijo, bo zbrala informacije o varnosti in učinkovitosti končnega pandemskega cepiva in jih predložila odboru CHMP v oceno.
In the second main study, 4,560 adults were given either Pumarix or placebo (a dummy vaccine). 
V drugi glavni študiji je 4 560 odraslih prejelo bodisi cepivo Pumarix ali placebo (cepivo brez aktivne učinkovine).
Pumarix should not be given to people who have had an anaphylactic reaction (severe allergic reaction) to any of the components of the vaccine, or to any of the substances found at trace levels in the vaccine, such as egg or chicken protein, ovalbumin (a protein in egg white), formaldehyde and sodium deoxycholate. 
Cepivo Pumarix se ne sme dajati osebam, ki so imele anafilaktično reakcijo (resno alergijsko reakcijo) na katero koli sestavino cepiva ali na katero koli od snovi, ki se v sledeh nahajajo v cepivu, kot so jajca, piščančje beljakovine, ovalbumin (beljakovina v beljaku), formaldehid, in natrijev deoksiholat.
People who have previously been vaccinated with a vaccine that contains the same adjuvant (a substance added to enhance the immune response) and a flu strain similar to the one causing the pandemic will only need one single dose. 
Osebe, ki so bile predhodno cepljene s cepivom, ki je vsebovalo enak adjuvans (snov, ki se doda za povečanje imunskega odziva) in sev gripe, podoben tistemu, ki povzroča pandemijo, bodo potrebovali samo en odmerek.
The emulsion contains the ‘adjuvant' to enhance the immune response. 
Emulzija vsebuje adjuvans za povečanje imunskega odziva.
The vaccine is given by injection into muscle, preferably into shoulder or thigh muscle. 
Cepivo se injicira v mišico, po možnosti v ramensko ali stegensko.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Pumarix. 
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Pumarix, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
Before use, the vaccine will be made up by mixing together a suspension that contains the virus particles with an emulsion. 
Pred uporabo se cepivo pripravi z mešanjem suspenzije, ki vsebuje delce virusa, in emulzije.
They can then test this vaccine to see how people react to it, allowing them to predict how people will react when the flu strain causing the pandemic is included. 
To cepivo lahko nato preskusijo, da bi preverili odziv ljudi nanj, na podlagi česar predvidijo tudi odziv, ko bo vključen sev gripe, ki povzroča pandemijo.
What benefit has Pumarix shown during the studies? 
Kakšne koristi je zdravilo Pumarix izkazalo med študijami?
This means that, because the vaccine is a mock up and does not yet contain the strain of flu virus that is causing a pandemic, it has not been possible to obtain full information about the final pandemic vaccine. 
To pomeni, da gre za modelno cepivo, ki še ne vsebuje seva virusa gripe, ki utegne povzročiti pandemijo, zato ni bilo možno pridobiti vseh podatkov o končnem pandemskem cepivu.
The most common side effects with Pumarix (seen in more than 1 patient in 10) are headache, joint pain, muscle ache, pain at injection site and fatigue (tiredness). 
Najpogostejši neželeni učinki zdravila Pumarix (opaženi pri več kot 1 bolniku od 10) so glavobol, bolečine v sklepih, boleče mišice, bolečina na mestu injiciranja in utrujenost.
During a pandemic, the virus strain in the vaccine will have to be replaced by the strain causing the pandemic before the vaccine can be used. 
Med pandemijo bo sev virusa v cepivu nadomeščen s sevom, ki povzroča pandemijo, preden bo cepivo mogoče uporabljati.
This vaccine contains small amounts of haemagglutinins (proteins from the surface) of a virus called H5N1. 
To cepivo vsebuje majhno količino hemaglutininov (beljakovin s površine) virusa, imenovanega H5N1.
Other information about Pumarix 
Druge informacije o zdravilu Pumarix :
One main study involving 680 adults compared Pumarix given as two doses three weeks apart with Pandemrix H5N1 (another pandemic influenza vaccine) and also compared Pumarix given with and without an adjuvant. 
V eni glavni študiji, v kateri je sodelovalo 680 odraslih, so cepivo Pumarix v dveh odmerkih v tritedenskem razmiku primerjali s cepivom Pandemrix H5N1 (drugo cepivo proti pandemski gripi), pa tudi uporabo z adjuvansom ali brez njega.
Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) 
Pumarix cepivo proti pandemski gripi (H5N1) (z delci virionov, inaktivirano, z adjuvansom)
What information is still awaited for Pumarix? 
Katere informacije o zdravilu Pumarix še pričakujemo?
However, it may be appropriate to give the vaccine to these patients during a pandemic, as long as facilities for resuscitation are available. 
Med pandemijo je cepljenje teh oseb morda vseeno upravičeno, vendar mora biti na voljo oprema za oživljanje.
The second study showed that Pumarix was able to trigger the production of antibodies to a level high enough to meet CHMP criteria. 
Druga študija je pokazala, da je cepivo Pumarix sposobno sprožiti nastanek protiteles na ravni, ki ustreza merilom CHMP.
The study also showed that Pumarix triggered the production of more antibodies when given with an adjuvant than when given without. 
Študija je pokazala tudi, da cepivo Pumarix spodbudi nastanek več protiteles, kadar je uporabljeno z adjuvansom kot brez njega.
What is the risk associated with Pumarix? 
Kakšna tveganja so povezana z zdravilom Pumarix?
In the first study, the immunogenicity of Pumarix was shown to be comparable to that of the comparator vaccine. 
Prva študija je pokazala, da cepivo Pumarix sproži primerljivo imunogenost kot primerjalno cepivo.
A flu pandemic happens when a new strain of flu virus appears that can spread easily from person to person because people have no immunity (protection) against it. A pandemic can affect most countries and regions around the world. 
Do pandemije pride, ko se pojavi nov sev virusa gripe, ki se med ljudmi hitro širi, ker proti njemu niso imuni (oziroma pred njim niso zaščiteni).
Pumarix is a vaccine to protect against ‘pandemic' flu. 
Zdravilo Pumarix je cepivo za zaščito pred pandemsko gripo.
Why has Pumarix been approved? 
Zakaj je bilo zdravilo Pumarix odobreno?
Pumarix is a ‘mock-up' vaccine. 
Zdravilo Pumarix je „modelno“ cepivo.
How has Pumarix been studied? 
Kako je bilo zdravilo Pumarix raziskano?
Pumarix is a vaccine that is given by injection. 
Zdravilo Pumarix je cepivo za injiciranje.
How does Pumarix work? 
Kako zdravilo Pumarix deluje?
How is Pumarix used? 
Kako se zdravilo Pumarix uporablja?
What is Pumarix used for? 
Za kaj se zdravilo Pumarix uporablja?
What is Pumarix? 
Kaj je zdravilo Pumarix?
Adopted at the 2-5 September 2019 PRAC 
Sprejeto na seji odbora PRAC med 2. in 5. septembrom 2019
2 Canagliflozin; canagliflozin, metformin; dapagliflozin; dapagliflozin, metformin; empagliflozin; empagliflozin, metformin; empagliflozin, linagliptin; ertugliflozin, metformin; ertugliflozin, sitagliptin; saxagliptin, dapagliflozin 
4 Kanagliflozin; kanagliflozin, metformin; dapagliflozin; dapagliflozin, metformin; empagliflozin; empagliflozin, metformin; empagliflozin, linagliptin; ertugliflozin, metformin; ertugliflozin, sitagliptin; saksagliptin, dapagliflozin
In both cases, tTreatment with <product name> may be restarted once when the ketone values are normal and the patient's condition has stabilised. 
V obeh primerih je mogoče dapagliflozinZdravljenje z zdravilom <ime zdravila> je mogoče znova uvesti, ko so vrednosti ketonov normalne in se bolnikovo stanje stabilizira.
EMA/PRAC/474668/2019 
EMA/PRAC/501726/2019 Corr2
Patients appear to be at highest risk of these reactions early in the course of therapy, the onset of the reaction occurring in the majority of cases within the first month of treatment. 
Zdi se, da te reakcije bolnike najbolj ogrožajo v zgodnjem obdobju zdravljenja, saj se reakcija večinoma pojavi v prvem mesecu zdravljenja.
Latency from the initiation of treatment with ibrutinib to the onset of ischemic central nervous vascular conditions was in the most cases after several months (more than 1 month in 78% and more than 6 months in 44% of cases) emphasizing the need for regular monitoring of patients (please see section 4.4 Cardiac arrhythmia and Hypertension and section 4.8). 
Latenca od začetka zdravljenja z ibrutinibom do pojava ishemičnih žilnih bolezni osrednjega živčevja je večinoma znašala nekaj mesecev (več kot 1 mesec v 78 % in več kot 6 mesecev v 44 % primerov), kar poudarja potrebo po rednem spremljanju bolnikov (glejte poglavje 4.4, Srčne aritmije in Hipertenzija, ter poglavje 4.8).
Frequency “Not known” 
Neznana pogostnost
Tell a doctor straight away if you notice any of the following side effects: Uncommon (may affect up to 1 in 100 people): temporary episode of neurologic dysfunction caused by loss of blood flow, stroke. 
Nemudoma obvestite svojega zdravnika, če opazite katerega od naslednjih neželenih učinkov: Občasni neželeni učinki (pojavijo se lahko pri največ 1 od 100 bolnikov): začasna epizoda nevrološke disfunkcije, ki jo povzroči izguba pretoka krvi, možganska kap.
Footnotes: 
Opombe:
Stop using <product name> if you develop these symptoms and seek medical attention immediately. 
Če se pri vas pojavijo ti simptomi, prenehajte uporabljati zdravilo <ime zdravila> in takoj poiščite zdravniško pomoč.