FrancophonIA/ELRC3.0 huggingface dataset:
English: This is a special type of vaccine that can be developed to help with the management of a future pandemic.
Croatian: U ovom dijelu opisuje se kliničko iskustvo s cjepivima spremnim protiv pandemijske influence.
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.
Croatian: Ovi antigeni se mogu smatrati kao „novi“ antigeni i simuliraju situaciju gdje je ciljna populacija za cijepljenje bez imunološke memorije.
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.
Croatian: U usporedbi s kontrolnom skupinom širenje virusa u gornje dišne puteve također je bilo smanjeno, ukazujući na smanjen rizik od prijenosa virusa.
English: The CHMP decided that the vaccine's benefits are greater than its risks and recommended that it be given marketing authorisation.
Croatian: OSTALI UVJETI I ZAHTJEVI ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET
English: It contains parts of influenza (flu) viruses that have been inactivated (killed).
Croatian: Virus influence (fragmentiran, inaktiviran), sadrži antigene* koji odgovaraju soju:
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.
Croatian: Osobe koje su ranije cijepljene s jednom ili dvije doze cjepiva Prepandrix koje sadrži hemaglutinine (HA) dobivene iz različitih linija istog podtipa influence kao virus pandemijske influence: Odrasle osobe starije od 18 godina: jedna doza od 0,5 ml odabranog datuma.
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.
Croatian: 1 geometrijska srednja vrijednost titra četverostruko povećanje titra neutralizirajućih protutijela u serumu 3 % ispitanika koji su dosegnuli titar neutralizirajućih protutijela u serumu od najmanje 1:80
English: • if you are older than 70 years of age.
Croatian: • ako imate više od 70 godina.
English: PC: {number} SN: {number} NN: {number
Croatian: PC: {broj} SN: {broj} NN: {broj}
English: OTHER SPECIAL WARNING, IF NECESSARY
Croatian: DRUGA POSEBNA UPOZORENJA, AKO JE POTREBNO
English: • uncontrolled bleeding,
Croatian: • nekontrolirano krvarenje,
English: Do not swallow it.)
Croatian: Nemojte je progutati.)
English: • increased skin sensitivity to sunlight
Croatian: • povećana osjetljivost kože na sunčevu svjetlost
English: • a severe headache that does not go away.
Croatian: • zimice, • jaku glavobolju koja ne prestaje.
English: As it cannot be excluded that the change in Cmax is clinically significant, Temozolomide Hexal should be administered without food.
Croatian: Budući da se ne može isključiti da je promjena Cmax klinički značajna, Temozolomid Hexal treba uzimati bez hrane.
English: • change in mental status or alertness
Croatian: • promjena psihičkog stanja ili budnosti
English: This is because you must not be treated with Temozolomide Hexal during pregnancy unless clearly indicated by your doctor.
Croatian: To je zbog toga što se ne smijete liječiti Temozolomidom Hexal tijekom trudnoće, osim ako ga Vaš liječnik nije izričito propisao.
English: • sexual impotence
Croatian: • seksualna impotencija
English: • The other ingredients of the capsule are
Croatian: • Drugi sastojci kapsule su
English: • if you are allergic to temozolomide or any of the other ingredients of this medicine (listed in section 6).
Croatian: • ako ste alergični na temozolomid ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
English: If a full day has gone by, check with your doctor.
Croatian: Ako je prošao cijeli dan, provjerite s
English: • increased sugar in the blood
Croatian: • povišena razina šećera u krvi
English: Always take Temozolomide Hexal exactly as your doctor has told you.
Croatian: Uvijek uzmite Temozolomid Hexal točno onako kako Vam je rekao Vaš liječnik.
English: Component of a multipack.
Croatian: Dio višestrukog pakiranja.
English: • absent or heavy menstrual periods
Croatian: • izostanak ili obilne menstruacije
English: • seizures (convulsions),
Croatian: • napadaje (konvulzije),
English: Contact your doctor immediately if you have any of the following:
Croatian: Obratite se svom liječniku odmah ako imate neki od sljedećih simptoma:
English: • if you develop fever or symptoms of an infection, contact your doctor immediately.
Croatian: • ako dobijete vrućicu ili simptome infekcije, odmah se javite svom liječniku.
English: Hexal AG Industriestraße 25 83607 Holzkirchen Germany
Croatian: Hexal AG Industriestraße 25 83607 Holzkirchen
English: • dry or painful eyes
Croatian: • suhe ili bolne oči
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.
Croatian: Ako često povraćate prije ili za vrijeme liječenja, upitajte svog liječnika u koje je vrijeme najbolje uzimati Temozolomid Hexal sve dok povraćanje ne bude pod kontrolom.
English: What Temozolomide Hexal is and what it is used for
Croatian: Što je Temozolomid Hexal i za što se koristi
English: • as you may have a small risk of other changes in blood cells, including leukaemia.
Croatian: • jer može postojati malen rizik od razvoja drugih promjena krvnih stanica, uključujući leukemiju.
English: If Temozolomid Hexal comes into contact with skin or mucosa, it should be washed immediately and thoroughly with soap and water.
Croatian: Ako Temozolomid Hexal dođe u kontakt s kožom ili sluznicom, to područje treba odmah temeljito isprati sapunom i vodom.
English: • a cold or the flu
Croatian: • prehlada ili gripa
English: If you take more Temozolomide Hexal than you should
Croatian: Ako uzmete više Temozolomida Hexal nego što ste trebali
English: Multipack (bottles)
Croatian: Višestruko pakiranje (bočice)
English: • anxiety/depression
Croatian: • tjeskoba/depresija
English: • hallucination and memory impairment
Croatian: • halucinacije i poremećaj pamćenja
English: Temozolomide Hexal should not be administered to pregnant women.
Croatian: Temozolomid Hexal ne smije se davati trudnicama.
English: Contents of the pack and other information What Temozolomide Hexal contains
Croatian: Sadržaj pakiranja i druge informacije Što Temozolomid Hexal sadrži
English: Temozolomide Hexal treatment can cause a reduction in certain kinds of blood cells.
Croatian: Liječenje Temozolomidom Hexal može izazvati smanjenje broja nekih vrsta krvnih stanica.
English: • if you have low counts of red blood cells (anaemia), white blood cells and platelets, or blood clotting problems before starting the treatment, or if you develop them during treatment.
Croatian: • ako imate smanjen broj crvenih krvnih stanica (anemiju), bijelih krvnih stanica i trombocita ili probleme sa zgrušavanjem krvi prije početka liječenja, ili se ti poremećaji razviju tijekom liječenja.
English: Figure 1 Kaplan-Meier curves for overall survival ( intent-to-treat population)
Croatian: Slika 1 Kaplan-Meierove krivulje ukupnog preživljenja (populacija koju se namjeravalo liječiti)
English: • difficulty concentrating
Croatian: • poteškoće s koncentracijom
English: Temozolomide Hexal contains lactose (a kind of sugar).
Croatian: Temozolomid Hexal sadrži laktozu (vrstu šećera).
English: If you accidentally take more Temozolomide Hexal capsules than you were told to, contact your doctor or pharmacist or nurse immediately .
Croatian: Ako uzmete više Temozolomid Hexal kapsula nego što ste trebali, odmah se javite svom liječniku, ljekarniku ili medicinskoj sestri.
English: Temozolomide Hexal is used in these tumours if they return or get worse after standard treatment.
Croatian: U ovom slučaju se Temozolomid Hexal koristi ako se tumor ponovno pojavio ili se pogoršava nakon standardne terapije.
English: Your doctor will work out your exact dose.
Croatian: Liječnik će izračunati točnu dozu koja Vam je potrebna.
English: You may be given other medicines (anti-emetics) to take before and/or after taking Temozolomide Hexal to prevent or control nausea and vomiting.
Croatian: Liječnik Vam može dati i neke druge lijekove (antiemetike) koje ćete uzimati prije i/ili nakon što uzmete Temozolomid Hexal radi izbjegavanja ili kontrole mučnine i povraćanja.
English: Take your prescribed dose of Temozolomide Hexal once a day, preferably at the same time each day.
Croatian: Uzmite propisanu dozu Temozolomida Hexal jedanput na dan, po mogućnosti svakoga dana u isto vrijeme.
English: 5 hard capsules.
Croatian: 5 tvrdih kapsula.
English: Following oral administration, approximately 5 % to 10 % of the dose is recovered unchanged in the urine over 24 hours, and the remainder excreted as temozolomide acid, 5-aminoimidazole-4-carboxamide (AIC) or unidentified polar metabolites.
Croatian: Nakon peroralne primjene se približno 5 % do 10 % doze nalazi u mokraći u nepromijenjenom obliku tijekom 24 sata, dok se ostatak izlučuje u obliku temozolomidske kiseline, 5-aminoimidazol-4-karboksamida (AIC) ili neidentificiranih polarnih metabolita.
English: • abnormal liver function tests.
Croatian: • odstupanja od normalnih vrijednosti testova funkcije jetre.
English: In some cases, it may be necessary to stop treatment with Temozolomide Hexal.
Croatian: U nekim će slučajevima možda biti neophodno prekinuti liječenje Temozolomidom Hexal.
English: What Temozolomide Hexal looks like and contents of the pack
Croatian: Kako Temozolomid Hexal izgleda i sadržaj pakiranja
English: • followed by treatment with only Temozolomide Hexal (monotherapy phase).
Croatian: • zatim liječenje samo lijekom Temozolomid Hexal (faza monoterapije).
English: Temozolomide Hexal is used for the treatment of specific forms of brain tumours:
Croatian: Temozolomid Hexal se koristi za liječenje određenih vrsta tumora mozga:
English: • cough • infections including pneumonia.
Croatian: • infekcije uključujući upalu pluća.
English: • double vision
Croatian: • dvostruke slike
English: Very rare cases of severe rash with skin swelling, including on the palms of the hands and soles of the feet, or painful reddening of the skin and/or blisters on the body or in the mouth have been observed.
Croatian: Vrlo rijetko su zabilježeni slučajevi jakog osipa s oticanjem kože, uključujući dlanove i tabane, ili bolnog crvenila kože i/ili mjehurića po tijelu ili u ustima.
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.
Croatian: • ako imate mučninu i/ili povraćanje što su vrlo česte nuspojave Temozolomida Hexal (pogledajte dio 4) liječnik Vam može propisati lijek koji sprečava povraćanje (antiemetik).
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
Croatian: Uputa o lijeku: Informacija za korisnika Temozolomid Hexal 5 mg tvrde kapsule Temozolomid Hexal 20 mg tvrde kapsule Temozolomid Hexal 100 mg tvrde kapsule Temozolomid Hexal 140 mg tvrde kapsule Temozolomid Hexal 180 mg tvrde kapsule Temozolomid Hexal 250 mg tvrde kapsule temozolomid
English: Other medicines and Temozolomide Hexal
Croatian: Drugi lijekovi i Temozolomid Hexal
English: • impaired balance
Croatian: • poremećaj ravnoteže
English: • a severe allergic (hypersensitive) reaction (hives, wheezing or other breathing difficulty),
Croatian: • jaku alergijsku reakciju (reakciju preosjetljivosti) (koprivnjača, piskanje pri disanju ili druge tegobe s disanjem),
English: • urticaria (hives)
Croatian: • urtikarija (koprivnjača)
English: Temozolomide Hexal may cause permanent infertility.
Croatian: Temozolomid Hexal može uzrokovati trajnu neplodnost.
English: • infection of the middle ear
Croatian: • infekcija srednjeg uha
English: In some cases, your Temozolomide Hexal dose will be reduced or treatment stopped.
Croatian: U nekim slučajevima će smanjiti dozu Temozolomida Hexal ili prekinuti liječenje.
English: • if you have liver or kidney problems.
Croatian: • ako imate problema s jetrom ili bubrezima.
English: • low potassium level in the blood
Croatian: • niska razina kalija u krvi
English: • The active substance is temozolomide.
Croatian: • Djelatna tvar je temozolomid.
English: cytomegalovirus infection, infection reactivation such as cytomegalovirus, hepatitis B virus†, meningoencephalitis herpetic†, sepsis†
Croatian: infekcija citomegalovirusom, reaktivacija infekcije kao što je citomegalovirus, virus hepatitisa B†, herpesni meningoencefalitis†, sepsa†
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.
Croatian: Bolesnici s tumorom koji se ponovno pojavio ili pogoršao (malignim gliomom, poput multiformnog glioblastoma ili anaplastičnog astrocitoma) koji uzimaju samo Temozolomid Hexal Ciklus liječenja Temozolomidom Hexal traje 28 dana.
English: • change in skin colour
Croatian: • promjena boje kože
English: Before each new treatment cycle, your blood will be tested to see if the Temozolomide dose needs to be adjusted.
Croatian: Prije svakog novog terapijskog ciklusa napravit će Vam se krvne pretrage kako bi se utvrdilo treba li prilagoditi dozu Temozolomida Hexal.
English: • constipation (difficulty passing stools)
Croatian: • konstipacija (otežano pražnjenje crijeva)
English: You should stop breast-feeding while receiving treatment with Temozolomide Hexal.
Croatian: Morate prekinuti dojenje dok se liječite Temozolomidom Hexal.
English: Opportunistic infections and reactivation of infections Opportunistic infections (such as Pneumocystis jirovecii pneumonia) and reactivation of infections (such as HBV, CMV) have been observed during the treatment with TMZ (see section 4.8).
Croatian: Oportunističke infekcije i reaktivacija infekcija Oportunističke infekcije (poput pneumonije uzrokovane s Pneumocystis jirovecii) i reaktivacija infekcija (poput HBV, CMV) su primijećene tijekom liječenja TMZ-om (vidjeti dio 4.8).
English: If you forget to take Temozolomide Hexal
Croatian: Ako ste zaboravili uzeti Temozolomid Hexal
English: The Temozolomide Hexal dose may be delayed or stopped, depending on your blood counts and how you tolerate your medicine during the concomitant phase.
Croatian: Doza Temozolomida Hexal se može odgoditi ili prekinuti ovisno o broju krvnih stanica i o tome kako podnosite lijek tijekom faze istodobnog liječenja.
English: If you are a newly-diagnosed patient (glioblastoma multiforme) you may be receiving Temozolomide Hexal for 42 days in combination with radiotherapy.
Croatian: Ako ste bolesnik s novodijagnosticiranim multiformnim glioblastomom, primat ćete Temozolomid Hexal u kombinaciji sa zračenjem tijekom 42 dana.
English: Temozolomide Hexal is first used together with radiotherapy (concomitant phase of treatment) and after that alone (monotherapy phase of treatment).
Croatian: Temozolomid Hexal se najprije koristi zajedno sa zračenjem (faza istodobnog liječenja), a zatim kao jedini lijek (faza monoterapije).
English: You will take Temozolomide Hexal alone once daily for the first 5 days.
Croatian: Uzimat ćete samo Temozolomid Hexal jedanput na dan prvih 5 dana.
English: • if you have had an allergic reaction to dacarbazine (an anticancer medicine sometimes called DTIC).
Croatian: • ako ste imali alergijsku reakciju na dakarbazin (antitumorski lijek).
English: • in children 3 years and older and adult patients with malignant glioma , such as glioblastoma multiforme or anaplastic astrocytoma.
Croatian: • u djece u dobi od 3 godine i starije te u odraslih bolesnika s malignim gliomom, kao što je multiformni glioblastom ili anaplastični astrocitom.
English: When laboratory abnormalities and adverse events were combined across concomitant and monotherapy treatment phases, Grade 3 or Grade 4 neutrophil abnormalities including neutropenic events were observed in 8 % of the patients.
Croatian: Kad su se objedinila odstupanja laboratorijskih nalaza i štetni događaji iz faze istodobnog liječenja i faze monoterapije, poremećaji broja neutrofila stupnja 3 ili 4, uključujući neutropeniju, zabilježeni su u 8 % bolesnika.
English: Do not store above 25°C
Croatian: Ne čuvati na temperaturi iznad 25 °C.
English: • loss of weight
Croatian: • gubitak tjelesne težine
English: Your blood will be tested frequently during treatment to monitor the side effects of Temozolomide Hexal on your blood cells.
Croatian: Tijekom liječenja će se često provoditi krvne pretrage radi praćenja nuspojava Temozolomida Hexal na krvne stanice.
English: After oral administration to adult patients, TMZ is absorbed rapidly with peak concentrations reached as early as 20 minutes post-administration (mean time between 0.5 and 1.5 hours).
Croatian: Apsorpcija Nakon peroralne primjene u odraslih bolesnika TMZ se brzo apsorbira te postiže vršne koncentracije već 20 minuta nakon primjene (srednje vrijeme između 0,5 i 1,5 sati).
English: TMZ was administered as salvage therapy in the follow-up phase in 161 patients of the 282 (57 %) in the RT alone arm, and 62 patients of the 277 (22 %) in the TMZ + RT arm.
Croatian: TMZ se primjenjivao kao „salvage“ (terapija spašavanja) pokušaj liječenja tijekom razdoblja praćenja u 161 od 282 bolesnika (57 %) u skupini u kojoj se primijenila samo RT te u 62 od 277 bolesnika (22 %) u skupini koja je uz RT primala i TMZ.
English: During the concomitant phase, your doctor will start Temozolomide Hexal at a dose of 75 mg/m2
Croatian: U fazi istodobnog liječenja liječnik će započeti primjenu Temozolomida Hexal u dozi od 75 mg/m2 (uobičajena doza).
English: • difficulty speaking
Croatian: • otežan govor
English: • muscle damage
Croatian: • oštećenje mišića
English: Temozolomide Hexal contains a medicine called temozolomide.
Croatian: Temozolomid Hexal sadrži lijek pod nazivom temozolomid.
English: An overdose of 10,000 mg (total dose in a single cycle, over 5 days) was taken by one patient and the adverse reactions reported were pancytopenia, pyrexia, multi-organ failure and death.
Croatian: Jedan je bolesnik uzeo preveliku dozu od 10 000 mg (ukupna doza tijekom 5 dana u jednom ciklusu), a prijavljene nuspojave bile su pancitopenija, pireksija, višeorgansko zatajenje i smrt.
English: What you need to know before you take Temozolomide Hexal Do not take Temozolomide Hexal
Croatian: Što morate znati prije nego počnete uzimati Temozolomid Hexal
English: Multipack: 20 (4 packs of 5) hard capsules
Croatian: Višestruko pakiranje (4 pakiranja od 5) tvrdih kapsula
English: Cases of elevations of liver enzymes have been commonly reported.
Croatian: Ostale nuspojave: Često su prijavljeni slučajevi povišenja jetrenih enzima.
English: Analysis of population-based pharmacokinetics of TMZ revealed that plasma TMZ clearance was independent of age, renal function or tobacco use.
Croatian: Posebne populacije Analiza populacijske farmakokinetike temozolomida otkrila je da klirens TMZ-a iz plazme ne ovisi o dobi, funkciji bubrega ni primjeni duhana.
English: Effective contraceptive precautions must be taken by both male and female patients who are taking Temozolomide Hexal (see also “Male fertility” below).
Croatian: I bolesnice i bolesnici koji uzimaju Temozolomid Hexal moraju primjenjivati učinkovite mjere kontracepcije (pogledajte i dio „Plodnost muškaraca“ u daljnjem tekstu).
English: You will again take Temozolomide Hexal once daily for 5 days followed by 23 days without Temozolomide Hexal.
Croatian: Ponovno ćete uzimati Temozolomid Hexal jedanput na dan tijekom 5 dana, nakon čega slijede 23 dana bez Temozolomida Hexal.
English: If you have not been previously treated with chemotherapy, your first dose of Temozolomide Hexal will be 200 mg/m2 once daily for the first 5 days.
Croatian: Ako niste prethodno liječeni kemoterapijom, prva doza Temozolomida Hexal bit će 200 mg/m2 jedanput na dan tijekom prvih 5 dana.
English: The body is imprinted with “5”.
Croatian: Na tijelu je otisnuta oznaka „5“.
English: Very common (≥ 1/10); Common (≥ 1/100 to < 1/10); Uncommon (≥ 1/1,000 to < 1/100); Rare
Croatian: Vrlo često (≥ 1/10), često (≥ 1/100 do < 1/10), manje često (≥ 1/1000 do < 1/100), rijetko (≥ 1/10 000
English: Tell your doctor immediately if this occurs.
Croatian: Ako se to dogodi, odmah obavijestite svog liječnika.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE CARTON FOR MULTIPACKS OF 20 (4 PACKS OF 5) HARD CAPSULES - WITHOUT THE BLUE BOX
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU SREDNJE PAKIRANJE ZA VIŠESTRUKO PAKIRANJE OD 20 (4 PAKIRANJA OD 5) TVRDIH KAPSULA- BEZ PLAVE KUTIJE
English: • nausea (feeling sick in your stomach)
Croatian: • povraćanje • mučnina (loš osjećaj u želucu)
English: Temozolomide Hexal should only be prescribed by physicians experienced in the oncological treatment of brain tumours.
Croatian: 4.2 Doziranje i način primjene Temozolomid Hexal smiju propisivati samo liječnici s iskustvom u onkološkom liječenju tumora mozga.
English: After oral administration of 14C-labelled TMZ, mean faecal excretion of 14C over 7 days post-dose was 0.8 %
Croatian: Nakon peroralne primjene temozolomida označenog radioizotopom 14C, srednja vrijednost izlučena u fecesu je tijekom 7 dana nakon primjene doze bila je 0,8 % radioizotopa 14C, što ukazuje na potpunu apsorpciju.
English: Cases of increased bilirubin, problems with bile flow (cholestasis), hepatitis and injury to the liver, including fatal liver failure, have been uncommonly reported.
Croatian: Manje često su prijavljeni slučajevi povišenja razine bilirubina, poteškoća s protokom žuči (kolestaza), hepatitisa i oštećenja jetre, uključujući i zatajenje jetre sa smrtnih ishodom.
English: • partial loss of vision
Croatian: • poremećaj osjeta • djelomičan gubitak vida
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON FOR MULTIPACKS OF 20 (4 PACKS OF 5) HARD CAPSULES - WITH THE BLUE BOX
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKO PAKIRANJE ZA VIŠESTRUKO PAKIRANJE OD 20 (4 PAKIRANJA OD 5) TVRDIH KAPSULA- S PLAVOM KUTIJOM
English: Patients with rare hereditary problems of galactose intolerance, the totallactase deficiency or glucose-galactose malabsorption should not take this medicine.
Croatian: potpunim nedostatkom laktaze ili malapsorpcijom glukoze i galaktoze ne bi smjeli uzimati ovaj lijek.
English: Temozolomide Hexal may make you feel tired or sleepy.
Croatian: Temozolomid Hexal može uzrokovati umor ili pospanost.
English: The bottles contain a desiccant pouch.)
Croatian: Bočice sadrže vrećicu sa sredstvom za sušenje.)
English: a: Treatment with concomitant TMZ can be continued when all of the following conditions are met: absolute neutrophil count ≥ 1.5 x 109/l; thrombocyte count ≥ 100 x 109/l; CTC non-haematological toxicity ≤ Grade 1 (except for alopecia,
Croatian: Istodobno liječenje TMZ-om može se nastaviti kada su zadovoljeni svi sljedeći uvjeti: apsolutni broj neutrofila ≥ 1,5 x 109/l; broj trombocita ≥ 100 x 109/l; nehematološka toksičnost prema CTC ≤ stupnja 1 (osim alopecije, mučnine i povraćanja).
English: Temozolomide Hexal contains lactose
Croatian: Temozolomid Hexal sadrži laktozu
English: Multipack containing 20 hard capsules (4 packs of 5 hard capsules in an amber glass bottle [Type 3 glass] with polypropylene child-resistant closure.
Croatian: Višestruko pakiranje sadrži 20 tvrdih kapsula (4 pakiranja od 5 tvrdih kapsula u bočici od smeđeg stakla (staklo tipa III) s polipropilenskim sigurnosnim zatvaračem za djecu.
English: • change in taste.
Croatian: • bol • promjene osjeta okusa.
English: Hard capsule (capsule)
Croatian: Tvrda kapsula (kapusla).