FrancophonIA/ELRC3.0 huggingface dataset:
English: The full EPAR for Adjupanrix can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Adjupanrix je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Adjupanrix on 19 October 2009.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Adjupanrix, veljavno po vsej Evropski uniji, odobrila dne 19. oktobra 2009.
English: For more information about treatment with this vaccine, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju s tem cepivom preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: What benefit has this vaccine shown during the studies?
Slovenian: Kakšne koristi je to cepivo izkazalo med študijami?
English: The vaccine contains a flu strain called ‘A/VietNam/1194/2004 NIBRG 14' (H5N1).
Slovenian: Cepivo vsebuje sev gripe, imenovan „A/VietNam/1194/2004 NIBRG 14“ (H5N1).
English: It contains parts of influenza (flu) viruses that have been inactivated (killed).
Slovenian: Vsebuje delce virusov influence (gripe), ki so bili inaktivirani (uničeni).
English: This is a summary of the European public assessment report (EPAR) for Adjupanrix.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Adjupanrix.
English: The main measures of effectiveness were the levels of antibodies against the flu virus in the blood at three different times: before vaccination, on the day of the second injection (day 21) and 21 days later (day 42).
Slovenian: Glavna merila učinkovitosti so bile ravni protiteles proti virusu gripe v krvi v treh različnih obdobjih: pred cepljenjem, na dan drugega cepljenja (21. dan) in 21 dni kasneje (42. dan).
English: The CHMP decided that the vaccine's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: CHMP je zaključil, da so koristi cepiva večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
English: The vaccine must 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 very low levels in the vaccine, such as eggs, chicken protein, ovalbumin (a protein in egg white), formaldehyde, gentamicin sulphate (an antibiotic) and sodium deoxycholate.
Slovenian: Cepivo 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 jih v zelo nizkih količinah najdemo v cepivu, kot so jajca, piščančje beljakovine, ovalbumin (beljakovina v beljaku), formaldehid, gentamicinijev sulfat (antibiotik) in natrijev deoksiholat.
English: Why has Adjupanrix been approved?
Slovenian: Zakaj je bilo zdravilo Adjupanrix odobreno?
English: What is the risk associated with this vaccine?
Slovenian: Kakšna tveganja so povezana s tem cepivom?
English: The resulting ‘emulsion' will then be injected.
Slovenian: Tako dobljena „emulzija“ se nato injicira.
English: The vaccine is given by injection into the shoulder or thigh muscle.
Slovenian: Cepivo se injicira v ramensko ali stegensko mišico.
English: The solvent contains an ‘adjuvant' (a compound containing oil) to enhance the immune response.
Slovenian: Emulzija vsebuje tudi „adjuvans“ (spojino, ki vsebuje olje) za povečanje imunskega odziva.
English: When the company that makes the vaccine includes the flu strain responsible for a pandemic in the vaccine, it will collect information on the safety and effectiveness of the final pandemic vaccine, and submit this to the CHMP for evaluation.
Slovenian: Ko bo družba, ki izdeluje cepivo, vanj vključila sev gripe, odgovoren za pandemijo, bo zbrala informacije o varnosti in učinkovitosti končnega pandemičnega cepiva in jih predložila CHMP v oceno.
English: The company that made the Pandemrix H5N1 mock-up vaccine has agreed that its scientific data can be used for this vaccine.
Slovenian: Družba, ki izdeluje modelno cepivo Pandemrix H5N1, je privolila, da se znanstveni podatki tega zdravila uporabljajo tudi za to cepivo.
English: This vaccine is the same as the Pandemrix H5N1 mock-up vaccine, which was previously authorised in the European Union (EU).
Slovenian: To cepivo je enako modelnemu cepivu Pandemrix H5N1, ki je že bilo odobreno v Evropski uniji (EU).
English: 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.
Slovenian: Lahko pa pripravijo cepivo, ki vsebuje posebej izbrani sev virusa gripe, kateremu je bilo izpostavljenih zelo malo ljudi oziroma so proti njemu imuni.
English: 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.
Slovenian: To cepivo lahko preizkusijo, da bi preverili odziv ljudi nanj, na podlagi česar lahko predvidijo, kako se bodo ti odzvali, ko se bo pojavil sev gripe, ki povzroča pandemijo.
English: People who have not previously been vaccinated against the pandemic flu with a ‘prepandemic' vaccine should receive two single 0.5 ml doses of the vaccine at least three weeks apart.
Slovenian: Osebe, ki predhodno niso bile cepljene proti pandemični gripi s „prepandemičnim“ cepivom, bi morale prejeti dva enojna 0,5-mililitrska odmerka cepiva v najmanj tritedenskem razmiku.
English: At 21 days after the second injection, 84% of the people receiving the vaccine had levels of antibodies that would protect them against H5N1.
Slovenian: 21 dni po drugem injiciranju je imelo 84 % oseb, ki so prejele cepivo, koncentracijo protiteles, ki bi jih zaščitila pred virusom H5N1.
English: Adjupanrix is a vaccine for use in adults to protect against ‘pandemic' flu.
Slovenian: Zdravilo Adjupanrix je cepivo za uporabo pri odraslih za zaščito pred „pandemično“ gripo.
English: In elderly people, single doses also met the CHMP's criteria, except for in the small number of patients aged over 80 years who did not have any protection against the virus at the start of the study.
Slovenian: Pri starejših osebah so enojni odmerki cepiva prav tako izpolnili merila odbora CHMP, razen pri manjšem številu bolnikov, starejših od 80 let, ki na začetku študije niso imeli razvite zaščite pred virusom.
English: 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 Adjupanrix.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Adjupanrix, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: Other information about Adjupanrix
Slovenian: Druge informacije o zdravilu Adjupanrix:
English: People who have previously been vaccinated with a prepandemic vaccine that contains a similar flu strain to the one causing the pandemic will only need one single dose.
Slovenian: Pri osebah, ki so bile predhodno cepljene s prepandemičnim cepivom, ki vsebuje sev gripe, podoben tistemu, ki povzroča pandemijo, bo potreben zgolj en enojni odmerek.
English: 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.
Slovenian: To pomeni, da gre za modelno cepivo, ki še ne vsebuje seva virusa gripe, ki utegne povzročiti pandemijo, zato ni bilo mogoče pridobiti vseh podatkov o končnem pandemičnem cepivu.
English: The most common side effects with the vaccine (seen with more than 1 in 10 doses of the vaccine) are headache, arthralgia (joint pain), myalgia (muscle pain), reactions at the site of the injection (hardening, swelling, pain and redness), fever and fatigue (tiredness).
Slovenian: Najpogostejši neželeni učinki cepiva (opaženi pri več kot 1 odmerku cepiva od 10) so glavobol, artralgija (bolečine v sklepih), mialgija (bolečine v mišicah), reakcije na mestu injiciranja (zatrdlina, oteklina, bolečina in rdečina), povišana telesna temperatura in utrujenost.
English: Before use, the vaccine will be made up by mixing together a suspension that contains the virus particles with a solvent.
Slovenian: Pred uporabo se cepivo pripravi z mešanjem suspenzije, ki vsebuje delce virusa, in vehikla.
English: For the full list of all side effects reported with this vaccine, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi tega cepiva, glejte navodilo za uporabo.
English: The main study showed that the 3.75 microgram dose of the adjuvanted vaccine produced an antibody response that met these criteria.
Slovenian: Glavna študija je pokazala, da je cepivo z adjuvansom v odmerku 3,75 mikrograma povzročilo odziv protiteles, in izpolnjuje ta merila.
English: A further study looked at the immunogenicity of single or double doses in 437 people aged over 60 years, and two studies looked at the effect of giving a single injection of the vaccine to adults who had previously been vaccinated with a prepandemic vaccine containing a related virus strain.
Slovenian: Nadaljnja študija je proučevala imunogenost enojnih ali dvojnih odmerkov pri 437 osebah, starih nad 60 let, dve študiji pa sta proučevali učinek cepljenja z enojnim odmerkom odraslih, ki so bili predhodno cepljeni s prepandemičnim cepivom, ki vsebuje soroden sev virusa.
English: The participants received two injections of the vaccine containing one of four different doses of haemagglutinin.
Slovenian: Osebe, ki so sodelovale v študiji, so prejele dve injekciji cepiva, ki sta vsebovali enega od štirih različnih odmerkov hemaglutinina.
English: The main study of the vaccine included 400 healthy adults aged between 18 and 60 years and compared the ability of different doses of the vaccine, with or without the adjuvant, to trigger the production of antibodies (‘immunogenicity').
Slovenian: V glavno študijo cepiva je bilo vključenih 400 zdravih odraslih oseb, starih od 18 do 60 let, v njej pa so primerjali učinkovitost različnih odmerkov virusa, z adjuvansom ali brez njega, pri sprožanju nastajanja protiteles („imunogenosti“).
English: What is Adjupanrix?
Slovenian: Kaj je zdravilo Adjupanrix?
English: The final two studies in adults showed that a single dose of the vaccine was sufficient to bring about protective levels of antibodies in people who had previously been vaccinated with a prepandemic vaccine containing a related flu strain.
Slovenian: Zadnji dve študiji pri odraslih sta pokazali, da je enojni odmerek cepiva učinkovito zagotavljal zaščitne ravni protiteles pri osebah, ki so bile predhodno cepljene s prepandemičnim cepivom, ki vsebuje soroden sev virusa gripe.
English: Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)
Slovenian: Povzetek EPAR za javnost cepivo proti pandemični gripi (H5N1) (z delci virionov, inaktivirano, z adjuvansom)
English: According to criteria laid down by the CHMP, a mock-up vaccine needs to bring about protective levels of antibodies in at least 70% of people for it to be considered suitable.
Slovenian: V skladu z merili, ki jih je določil CHMP, je modelno cepivo ustrezno učinkovito le, če zagotovi zaščitno raven protiteles pri vsaj 70 % ljudi.
English: In children aged three to nine years, the half-dose vaccine was shown bring about levels of antibodies that were comparable with the full-dose vaccine.
Slovenian: Pri otrocih, starih od tri do devet let, je polovični odmerek cepiva ustvaril takšne ravni protiteles, ki so primerljive z ravnmi pri polnem odmerku cepiva.
English: 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.
Slovenian: Pandemija gripe nastopi, ko se pojavi nov sev virusa gripe, ki se med ljudmi hitro širi, ker proti njemu niso imuni (zaščiteni).
English: A study in 405 children three to nine years of age looked at the immunogenicity triggered by a vaccine containing half the amount of haemagglutinins compared with the vaccine containing the full amount.
Slovenian: Študija, ki je vključevala 405 otrok, starih od tri do devet let, je proučevala imunogenost, ki jo je sprožilo cepivo s polovično količino hemaglutininov v primerjavi s cepivom, ki vsebuje celotno količino hemaglutininov.
English: Adjupanrix is a vaccine that is given by injection.
Slovenian: Zdravilo Adjupanrix je cepivo za injiciranje.
English: Adjupanrix is a ‘mock-up' vaccine.
Slovenian: Zdravilo Adjupanrix je „modelno“ cepivo.
English: What is this vaccine used for?
Slovenian: Za kaj se to cepivo uporablja?
English: How has this vaccine been studied?
Slovenian: Kako je bilo to cepivo raziskano?
English: How does this vaccine work?
Slovenian: Kako to cepivo deluje?
English: How is this vaccine used?
Slovenian: Kako se to cepivo uporablja?
English: Strength Pharmaceutical Form Route of administration Packaging
Slovenian: 20 mg pantoprazola na 1 tableto 7 ablet
English: Invented name
Slovenian: Številka EU Izmišljeno ime ovojnina vsebina velikost pakiranja
English: PC: {number} SN: {number} NN: {number
Slovenian: PC: {številka} SN: {številka} NN: {številka}
English: Do not swallow it.)
Slovenian: Ne pogoltnite je.)
English: Not to be sold separately.
Slovenian: Ni za ločeno prodajo.
English: Component of a multipack.
Slovenian: Sestavina večkratnega pakiranja.
English: Each hard capsule (capsule) is individually packed in a sachet.
Slovenian: Vsaka trda kapsula (kapsula) je posamezno pakirana v vrečico.
English: You will take this dose every day for 42 days (up to 49 days) in combination with radiotherapy.
Slovenian: Ta odmerek boste jemali 42 dni vsak dan (do 49 dni) v kombinaciji z radioterapijo.
English: • absent or heavy menstrual periods
Slovenian: • odsotne ali močne menstruacije,
English: Hexal AG Industriestraße 25 83607 Holzkirchen Germany
Slovenian: Hexal AG Industriestraße 25 83607 Holzkirchen
English: If Temozolomid Hexal comes into contact with skin or mucosa, it should be washed immediately and thoroughly with soap and water.
Slovenian: Če pride zdravilo Temozolomid Hexal v stik s kožo ali sluznico, jo morate takoj in temeljito umiti z milom in vodo.
English: Temozolomide Hexal is used in these tumours if they return or get worse after standard treatment.
Slovenian: Zdravilo Temozolomid Hexal se pri teh tumorjih uporablja, če se po standardnem zdravljenju ponovijo ali poslabšajo.
English: As it cannot be excluded that the change in Cmax is clinically significant, Temozolomide Hexal should be administered without food.
Slovenian: Ker ni mogoče izključiti možnosti, da bi bila sprememba Cmax lahko klinično pomembna, naj bolniki jemljejo zdravilo Temozolomid Hexal brez hrane.
English: This is because you must not be treated with Temozolomide Hexal during pregnancy unless clearly indicated by your doctor.
Slovenian: To morate storiti zato, ker se med nosečnostjo ne smete zdraviti z zdravilom Temozolomid Hexal, razen če vam je to izrecno predpisal zdravnik.
English: This may cause you to have increased bruising or bleeding, anaemia (a shortage of red blood cells), fever, and reduced resistance to infections.
Slovenian: Posledice so lahko povečana nagnjenost k podplutbam ali krvavitvam, anemija (pomanjkanje rdečih krvnih celic), zvišana telesna temperatura in zmanjšana odpornost proti okužbam.
English: Temozolomide Hexal treatment can cause a reduction in certain kinds of blood cells.
Slovenian: Zdravljenje z zdravilom Temozolomid Hexal lahko povzroči zmanjšanje števila nekaterih vrst krvnih celic.
English: If you vomit frequently before or during treatment, ask your doctor about the best time to take Temozolomide Hexal until the vomiting is under control.
Slovenian: Če pred zdravljenjem ali med njim pogosto bruhate, se posvetujte z zdravnikom o tem, kateri je najprimernejši čas za jemanje zdravila Temozolomid Hexal, dokler bruhanje ne bo pod nadzorom.
English: † Including cases with fatal outcome * Frequencies estimated based on relevant clinical trials
Slovenian: † vključno s primeri s smrtnim izidom * ocena pogostnosti temelji na ustreznih kliničnih preskušanjih
English: Summary of events reported with temozolomide in the post-marketing setting
Slovenian: Povzetek dogodkov, o katerih so poročali pri uporabi temozolomida v obdobju trženja
English: Multipack (Bottles)
Slovenian: Večkratno pakiranje (steklenice)
English: • if you have nausea (feeling sick in your stomach) and/or vomiting which are common side effects of Temozolomide Hexal (see section 4), your doctor may prescribe you a medicine (an anti-emetic) to help prevent vomiting.
Slovenian: • če imate navzeo (občutek slabosti) in/ali bruhate, kar sta zelo pogosta neželena učinka zdravljenja z zdravilom Temozolomid Hexal (glejte poglavje 4), vam bo zdravnik morda predpisal zdravilo (antiemetik), ki vam bo pomagalo preprečiti bruhanje.
English: Temozolomide Hexal may make you feel tired or sleepy.
Slovenian: Zdravilo Temozolomid Hexal lahko povzroči utrujenost ali zaspanost.
English: 5 hard capsules.
Slovenian: 5 trdih kapsul.
English: During the monotherapy phase, the dose and way you take Temozolomide Hexal will be different.
Slovenian: Med fazo zdravljenja z enim zdravilom bosta odmerek in način odmerjanja zdravila Temozolomid Hexal drugačna.
English: In some cases, your Temozolomide Hexal dose will be reduced or treatment stopped.
Slovenian: V nekaterih primerih bo odmerek zdravila Temozolomid Hexal zmanjšal ali zdravljenje prekinil.
English: Take your prescribed dose of Temozolomide Hexal once a day, preferably at the same time each day.
Slovenian: Predpisani odmerek zdravila Temozolomid Hexal vzemite enkrat dnevno, najbolje vsak dan ob istem času.
English: What Temozolomide Hexal is and what it is used for
Slovenian: Kaj je zdravilo Temozolomid Hexal in za kaj ga uporabljamo
English: Temozolomide Hexal should not be administered to pregnant women.
Slovenian: Zdravilo Temozolomid Hexal se ne sme dajati nosečnicam.
English: What you need to know before you take Temozolomide Hexal Do not take Temozolomide Hexal
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Temozolomid Hexal Ne uporabljajte zdravila Temozolomid Hexal
English: Effective contraceptive precautions must be taken by both male and female patients who are taking Temozolomide Hexal (see also “Male fertility” below).
Slovenian: Bolnice in bolniki, ki jemljejo zdravilo Temozolomid Hexal, morajo uporabljati učinkovito kontracepcijsko metodo (glejte tudi ″Plodnost pri moških″ spodaj).
English: What Temozolomide Hexal is and what it is used for What you need to know before you take Temozolomide Hexal How to take Temozolomide Hexal Possible side effects
Slovenian: Kaj je zdravilo Temozolomid Hexal in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Temozolomid Hexal Kako jemati zdravilo Temozolomid Hexal
English: Temozolomide Hexal should only be prescribed by physicians experienced in the oncological treatment of brain tumours.
Slovenian: Temozolomid Hexal smejo predpisati le zdravniki, ki imajo izkušnje z zdravljenjem možganskih tumorjev.
English: Temozolomide Hexal is used for the treatment of specific forms of brain tumours:
Slovenian: Zdravilo Temozolomid Hexal se uporablja za zdravljenje določenih vrst možganskih tumorjev:
English: Do not store above 25°C
Slovenian: Shranjujte pri temperaturi do 25 °C.
English: Patients with rare hereditary problems of galactose intolerance, the totallactase deficiency or glucose-galactose malabsorption should not take this medicine.
Slovenian: Bolniki z redko dedno intoleranco za galaktozo, odsotnostjo encima laktaze ali malabsorpcijo glukoze/galaktoze ne smejo jemati tega zdravila.
English: The Temozolomide Hexal dose may be adjusted, delayed or stopped depending on your blood counts and how you tolerate your medicine during each treatment cycle.
Slovenian: Temozolomid Hexal lahko prilagodijo, prestavijo ali zdravljenje prekinejo glede na vašo krvno sliko in na to, kako dobro prenašate zdravilo med vsakim ciklom zdravljenja.
English: You will again receive Temozolomide Hexal once daily for 5 days, followed by 23 days without Temozolomide Hexal.
Slovenian: Znova boste 5 dni jemali zdravilo Temozolomid Hexal enkrat na dan, nato pa bo sledilo 23 dni brez zdravila Temozolomid Hexal.
English: • followed by treatment with only Temozolomide Hexal (monotherapy phase).
Slovenian: • nato sledi zdravljenje samo z zdravilom Temozolomid Hexal (faza samostojnega zdravljenja).
English: Figure 1 Kaplan-Meier curves for overall survival ( intent-to-treat population)
Slovenian: Kaplan-Meierjeve krivulje skupnega preživetja (populacija, ki naj bi jo zdravili)
English: Contents of the pack and other information What Temozolomide Hexal contains
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Temozolomid Hexal
English: Temozolomide Hexal contains lactose (a kind of sugar).
Slovenian: Zdravilo Temozolomid Hexal vsebuje laktozo (vrsto sladkorja).
English: There is limited information in patients over 3 years of age who have taken Temozolomide Hexal.
Slovenian: Število podatkov pri bolnikih, starejših od 3 let, ki so jemali zdravilo Temozolomid Hexal, je omejeno.
English: Other medicines and Temozolomide Hexal
Slovenian: Druga zdravila in Temozolomid Hexal
English: Before each new treatment cycle, your blood will be tested to see if the Temozolomide dose needs to be adjusted.
Slovenian: Pred vsakim novim ciklom zdravljenja se preveri vaša krvna slika, da se lahko prilagodi odmerek zdravila Temozolomid Hexal.
English: Temozolomide Hexal is first used together with radiotherapy (concomitant phase of treatment) and after that alone (monotherapy phase of treatment).
Slovenian: Temozolomid Hexal se najprej uporablja skupaj s terapijo z obsevanjem (sočasna faza zdravljenja), nato pa samostojno (faza zdravljenja z enim zdravilom).
English: Patients with tumours that have returned or worsened (malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma) taking Temozolomide Hexal only: A treatment cycle with Temozolomide Hexal lasts 28 days.
Slovenian: Bolniki s tumorji, ki so se ponovili ali poslabšali (maligni gliomi, kot sta multiformni glioblastom ali anaplastični astrocitom) in jemljejo samo zdravilo Temozolomid Hexal
English: Package leaflet: information for the user Temozolomide Hexal 5 mg hard capsules Temozolomide Hexal 20 mg hard capsules Temozolomide Hexal 100 mg hard capsules Temozolomide Hexal 140 mg hard capsules Temozolomide Hexal 180 mg hard capsules Temozolomide Hexal 250 mg hard capsules temozolomide
Slovenian: Navodilo za uporabo Temozolomid Hexal 5 mg trde kapsule Temozolomid Hexal 20 mg trde kapsule Temozolomid Hexal 100 mg trde kapsule Temozolomid Hexal 140 mg trde kapsule Temozolomid Hexal 180 mg trde kapsule Temozolomid Hexal 250 mg trde kapsule temozolomid
English: 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: frequency cannot be estimated from the available data.
Slovenian: 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), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: In some cases, it may be necessary to stop treatment with Temozolomide Hexal.
Slovenian: V nekaterih primerih je treba zdravljenje z zdravilom Temozolomid Hexal prekiniti.
English: • a severe headache that does not go away.
Slovenian: • hud neprekinjen glavobol.
English: Keep the desiccant pouch in the bottle.
Slovenian: Vrečko s sušilom shranjujte v steklenici.
English: Temozolomide Hexal contains lactose
Slovenian: Temozolomid Hexal vsebuje laktozo