FrancophonIA/ELRC3.0 huggingface dataset:
English: The Temodal dose may be delayed or stopped, depending on your blood counts and how you tolerate your medicine during the concomitant phase.
Croatian: Uzimanje lijeka Temodal može se odgoditi ili prekinuti ovisno o broju Vaših krvnih stanica i o tome kako podnosite lijek tijekom faze istodobnog liječenja.
English: Frequency groupings are defined according to the following convention: 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).
Croatian: Učestalost pojavljivanja razvrstana je prema sljedećoj konvenciji: vrlo često (≥ 1/10), (često ≥1 /100 i < 1/10), manje često (≥ 1/1000 i < 1/100), rijetko (≥1/10 000 i <1/1000), vrlo rijetko (<1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Thus, prophylaxis against PCP is required for all patients receiving concomitant TMZ and RT for the 42-day regimen (with a maximum of 49 days) regardless of lymphocyte count.
Croatian: Stoga je potrebno primijeniti profilaksu protiv Pneumocystis jirovecii pneumonije u svih bolesnika koji istodobno primaju TMZ i RT prema režimu liječenja od 42 dana (najdulje 49 dana), bez obzira na broj limfocita.
English: Abdominal distension, faecal incontinence, gastrointestinal disorder, haemorrhoids, mouth dry
Croatian: distenzija abdomena, inkontinencija stolice, gastrointestinalni poremećaj, hemoroidi, suhoća usta
English: 5 hard capsules in sachets 20 hard capsules in sachets
Croatian: 5 tvrdih kapsula u vrećicama 20 tvrdih kapsula u vrećicama
English: Temodal is available in a glass vial, with a butyl rubber stopper and aluminium seal with a flip-off bonnet.
Croatian: Temodal je dostupan u staklenoj bočici s čepom od butilne gume i aluminijskim zaštitnim zatvaračem s "flip-off" kapicom.
English: Oral TMZ has been studied in paediatric patients (age 3-18 years) with recurrent brainstem glioma or recurrent high grade astrocytoma, in a regimen administered daily for 5 days every 28 days.
Croatian: Peroralno primijenjen TMZ ispitivan je u pedijatrijskih bolesnika (u dobi od 3 do 18 godina) s recidivirajućim gliomom moždanog debla ili recidivirajućim astrocitomom visokog stupnja prema režimu doziranja jedanput na dan tijekom 5 dana svakih 28 dana.
English: If Temodal 2.5 mg/ml comes into contact with skin or mucosa, it should be washed immediately and thoroughly with soap and water.
Croatian: Ako Temodal 2,5 mg/ml dođe u kontakt s kožom ili sluznicom, to područje treba odmah i temeljito isprati sapunom i vodom.
English: If you take more Temodal than you should If you accidentally take more Temodal capsules than you were told to, contact your doctor, pharmacist or nurse immediately.
Croatian: Ako uzmete više Temodal kapsula nego što ste trebali, odmah se javite liječniku, ljekarniku ili medicinskoj sestri.
English: Therefore, men being treated with it should be advised not to father a child up to 6 months after receiving the last dose and to seek advice on cryoconservation of sperm prior to treatment, because of the possibility of irreversible infertility due to therapy with TMZ.
Croatian: Stoga, muškarcima koji se liječe ovim lijekom treba savjetovati da ne začinju dijete do 6 mjeseci nakon primanja posljednje doze lijeka te da se prije početka liječenja posavjetuju oko pohrane sperme zamrzavanjem, jer postoji mogućnost da terapija TMZ-om dovede do trajne neplodnosti.
English: For sodium, see leaflet for further information.
Croatian: Za dodatne informacije pročitajte uputu o lijeku.
English: Your doctor will work out your dose of Temodal.
Croatian: Vaš liječnik će izračunati dozu lijeka Temodal primjerenu za Vas.
English: CTC Grade 3 or 4
Croatian: CTC stupnja 3 ili 4
English: Type I amber glass bottles with polypropylene child-resistant closures containing 5 or 20 hard capsules.
Croatian: Boce od smeđeg stakla tipa I, s polipropilenskim sigurnosnim zatvaračima za djecu, koje sadrže 5 ili 20 tvrdih kapsula.
English: In an open-label, two-way crossover bioequivalence study of the pharmacokinetics of oral and intravenous TMZ in patients with primary CNS malignancies, Temodal 2.5 mg/ml powder for solution for infusion administered over 90 minutes was found to be bioequivalent for Cmax and AUC
Croatian: U otvorenom, dvostruko križnom ispitivanju bioekvivalencije farmakokinetike peroralno i intravenski primijenjenog TMZ-a u bolesnika s primarnim zloćudnim tumorima SŽS-a utvrđeno je da su Cmax i AUC temozolomida i MTIC-a nakon primjene lijeka Temodal 2,5 mg/ml prašak za otopinu za infuziju tijekom 90 minuta ekvivalentni onima nakon primjene Temodal tvrdih kapsula u dozi od 150 mg/m
English: Talk to your doctor, pharmacist or nurse before taking Temodal, - as you should be observed closely for the development of a serious form of chest infection called Pneumocystis jirovecii pneumonia (PCP).
Croatian: Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego uzmete Temodal, - jer će Vas se morati pomno nadzirati zbog moguće pojave teškog oblika upale pluća uzrokovane s Pneumocystis jirovecii.
English: This medicine contains 2.4 mmol sodium per vial.
Croatian: Ovaj lijek sadrži 2,4 mmol natrija po dozi.
English: In addition to the side effects listed above, the following may also occur with the use of Temodal powder for solution for infusion: pain, irritation, itching, warmth, swelling or redness at the injection site; also bruising (haematoma).
Croatian: Osim gore navedenih nuspojava, kod primjene Temodal praška za otopinu za infuziju mogu se javiti i sljedeće nuspojave: bol, nadraženost, svrbež, osjećaj topline, oticanje ili crvenilo na mjestu injiciranja, kao i stvaranje modrica (hematoma).
English: This was followed by monotherapy TMZ (150 - 200 mg/m2) on Days 1 - 5 of every 28-day cycle for up to 6 cycles, starting 4 weeks after the end of RT.
Croatian: Nakon toga slijedila je monoterapija TMZ-om (150-200 mg/m2) od 1. do 5. dana svakog ciklusa od 28 dana.
English: Adverse reactions observed in clinical studies and reported from post-marketing use of TMZ are listed in Table 4.
Croatian: U Tablici 4 navedene su nuspojave opažene u kliničkim ispitivanjima i prijavljene nakon stavljanja TMZ-a u promet.
English: TMZ is administered orally at a dose of 75 mg/m2 daily for 42 days concomitant with focal radiotherapy (60 Gy administered in 30 fractions).
Croatian: TMZ se primjenjuje peroralno u dozi od 75 mg/m2 na dan tijekom 42 dana uz istodobnu radioterapiju (60 Gy primijenjenih u 30 frakcija).
English: You will receive your new dose of Temodal alone once daily for the first 5 days of each cycle.
Croatian: Primit ćete novu dozu lijeka Temodal jedanput na dan prvih 5 dana svakog ciklusa.
English: Dose levels include 100 mg/m 2, 150 mg/m 2, and
Croatian: Razine doza su 100 mg/m 2, 150 mg/m 2 i 200 mg/m 2.
English: Temodal contains lactose
Croatian: Temodal sadrži laktozu
English: The hard capsules for oral use are dispensed in amber glass bottles containing 5 or 20 capsules.
Croatian: Tvrde kapsule za primjenu kroz usta dostupne su u smeđim staklenim bocama koje sadrže 5 ili 20 kapsula.
English: These reactions are classified according to System Organ Class and frequency.
Croatian: Nuspojave su razvrstane prema klasifikaciji organskih sustava i učestalosti pojavljivanja.
English: The dose should be reduced or administration discontinued according to Table 3.
Croatian: Dozu treba smanjiti ili prekinuti davanje lijeka sukladno naputcima u Tablici 3.
English: If you have been previously treated with chemotherapy, your first dose of Temodal will be 150 mg/m2 once daily for the first 5 days.
Croatian: Ako ste ranije već liječeni kemoterapijom, prva doza lijeka Temodal bit će 150 mg/m2 jedanput na dan tijekom prvih pet dana.
English: What Temodal is and what it is used for What you need to know before you use Temodal How to use Temodal
Croatian: Što je Temodal i za što se koristi Što morate znati prije nego počnete primjenjivati Temodal Kako primjenjivati Temodal
English: TMZ dosing interruption or discontinuation during concomitant radiotherapy and TMZ
Croatian: Privremen ili trajan prekid primjene TMZ-a tijekom faze istodobnog liječenja radioterapijom i TMZ-om Toksičnost
English: What Temodal is and what it is used for What you need to know before you take Temodal How to take Temodal
Croatian: Što je Temodal i za što se koristi Što morate znati prije nego počnete uzimati Temodal Kako uzimati Temodal
English: What you need to know before you take Temodal
Croatian: Što morate znati prije nego počnete uzimati Temodal
English: Hemianopia, vision blurred, vision disorder e, visual field defect, diplopia, eye pain
Croatian: hemianopija, zamagljen vid, poremećaj vida e, ispad vidnog polja, diplopija, bol u oku
English: - if certain kinds of blood cells are severely reduced (myelosuppression), such as your white blood cell count and platelet count.
Croatian: - ako imate jako smanjen broj određenih vrsta krvnih stanica (mijelosupresiju), primjerice bijelih krvnih stanica ili trombocita.
English: Stomatitis, abdominal pain h, dyspepsia, dysphagia
Croatian: stomatitis, bol u abdomenu h, dispepsija, disfagija
English: Clear type I glass vial sealed with bromobutyl rubber stopper and aluminium overseal with peach-coloured flip-off bonnet.
Croatian: Staklena bočica od prozirnog stakla tipa I, s čepom od bromobutilne gume i aluminijskim zaštitnim zatvaračem s "flip-off" kapicom boje breskve.
English: A treatment cycle with Temodal lasts 28 days.
Croatian: Ciklus liječenja lijekom Temodal traje 28 dana.
English: Febrile neutropenia, neutropenia, thrombocytopenia, lymphopenia, leukopenia, anaemia
Croatian: febrilna neutropenija, neutropenija, trombocitopenija, limfopenija, leukopenija, anemija
English: Caution must be exercised in handling Temodal 2.5 mg/ml powder for solution for infusion.
Croatian: Potreban je oprez pri rukovanju lijekom Temodal 2,5 mg/ml prašak za otopinu za infuziju.
English: Status epilepticus, hemiplegia, extrapyramidal disorder, parosmia, gait abnormality, hyperaesthesia, sensory disturbance, coordination abnormal
Croatian: epileptični status (status epilepticus), hemiplegija, ekstrapiramidalni poremećaj, parosmija, poremećaj hoda, hiperestezija, poremećaj osjeta, poremećaj koordinacije
English: If a capsule becomes damaged, contact of the powder contents with skin or mucous membrane must be avoided.
Croatian: Ako se kapsula ošteti, mora se izbjegavati kontakt kože ili sluznice s praškastim sadržajem kapsule.
English: After reconstitution: 14 hours at 25 C, including infusion time.
Croatian: Nakon pripreme: 14 sati na temperaturi od 25°C, uključujući i vrijeme trajanja infuzije.
English: Includes pharyngitis, nasopharyngeal pharyngitis, pharyngitis Streptococcal Includes gastroenteritis, gastroenteritis viral Includes cushingoid, Cushing syndrome Includes neuropathy, peripheral neuropathy, polyneuropathy, peripheral sensory neuropathy, peripheral motor neuropathy Includes visual impairment, eye disorder Includes deafness, deafness bilateral, deafness neurosensory, deafness unilateral Includes earache, ear discomfort Includes abdominal pain, abdominal pain lower, abdominal pain upper, abdominal discomfort Includes oedema peripheral, peripheral swelling Includes liver function test increased, alanine aminotransferase increased, aspartate aminotransferase increased, hepatic enzymes increased Includes radiation injury, radiation skin injury Including cases with fatal outcome
Croatian: Uključuje faringitis, nazofaringealni faringitis, streptokokni faringitis Uključuje gastroenteritis, virusni gastroenteritis Uključuje Cushingoidni izgled, Cushingov sindrom Uključuje neuropatiju, perifernu neuropatiju, polineuropatiju, perifernu senzornu neuropatiju, perifernu motoričku neuropatiju Uključuje poremećaj vida, poremećaj oka Uključuje gluhoću, obostranu gluhoću, neurosenzornu gluhoću, jednostranu gluhoću Uključuje bol u uhu, nelagodu u uhu Uključuje bol u abdomenu, bol u donjem dijelu abdomena, bol u gornjem dijelu abdomena, nelagodu u abdomenu Uključuje periferni edem, periferno oticanje Uključuje povišene vrijednosti parametara jetrene funkcije, povišene vrijednosti alanin aminotransferaze, povišene vrijednosti aspartat aminotransferaze, povišene vrijednosti jetrenih enzima Uključuje oštećenje zbog zračenja, oštećenje kože zbog zračenja Uključujući slučajeve sa smrtnim ishodom
English: Temodal 2.5 mg/ml powder for solution for infusion must be administered only by intravenous infusion.
Croatian: Temodal 2,5 mg/ml prašak za otopinu za infuziju mora se primijeniti isključivo intravenskom infuzijom.
English: The carton contains 5 or 20 hard capsules, individually sealed in sachets.
Croatian: Pakiranje sadrži 5 ili 20 tvrdih kapsula, pojedinačno zatvorenih u vrećice.
English: Patients with tumours that have returned or worsened (malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma) taking Temodal only:
Croatian: Bolesnici s tumorom koji se ponovno pojavio ili pogoršao (malignim gliomom, poput multiformnog glioblastoma ili anaplastičnog astrocitoma), koji primaju samo Temodal:
English: If you have not been previously treated with chemotherapy, your first dose of Temodal will be 200 mg/m2 once daily for the first 5 days.
Croatian: Ako niste prethodno liječeni kemoterapijom, prva doza lijeka Temodal bit će 200 mg/m2 jedanput na dan tijekom prvih pet dana.
English: Ask your doctor or pharmacist to write it down (including the colour).
Croatian: Zamolite liječnika ili ljekarnika da Vam to zapiše
English: Temodal 2.5 mg/ml is supplied as a pack of 1 vial.
Croatian: Temodal 2,5 mg/ml dostupan je u pakiranju od 1 bočice.
English: Temodal powder for solution for infusion
Croatian: Temodal prašak za otopinu za infuziju
English: Powder for solution for infusion 1 vial 100 mg
Croatian: Prašak za otopinu za infuziju 1 bočica 100 mg
English: The cytotoxicity of MTIC is thought to be due primarily to alkylation at the O
Croatian: Smatra se da je za citotoksičnost MTIC-a primarno odgovorna alkilacija na položaju gvanina
English: In a 400 subject recurrent glioma data set, Grade 4 neutropenia occurred in 8 % of female vs 4 % of male subjects and Grade 4 thrombocytopenia in 8 % of female vs 3 % of male subjects in the first cycle of therapy.
Croatian: Prema podacima za 400 ispitanika s recidivirajućim gliomom, neutropenija stupnja 4 se u prvom ciklusu terapije razvila u 8% žena naspram 4% muškaraca, a trombocitopenija stupnja 4 u 8% žena naspram 3% muškaraca.
English: Drug reaction with eosinophilia and systemic symptoms (DRESS)
Croatian: reakcija na lijek s eozinofilijom i sistemskim simptomima (engl, drug reaction with eosinophilia and systemic symptoms, DRESS)
English: Warnings and precautions Talk to your doctor, pharmacist or nurse before using Temodal, - as you should be observed closely for the development of a serious form of chest infection called Pneumocystis jirovecii pneumonia (PCP).
Croatian: Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego primijenite Temodal, - jer će Vas se morati pomno nadzirati zbog moguće pojave teškog oblika upale pluća uzrokovane s Pneumocystis jirovecii.
English: The other ingredients are: capsule content: anhydrous lactose, colloidal anhydrous silica, sodium starch glycolate type A, tartaric acid, stearic acid (see section 2 "Temodal contains lactose").
Croatian: Sadržaj kapsule: bezvodna laktoza, koloidni, bezvodni silicijev dioksid, natrijev škroboglikolat, vrste A, tartaratna kiselina, stearatna kiselina (pogledajte dio 2 "Temodal sadrži laktozu").
English: Condition aggravated, rigors, face oedema, tongue discolouration, thirst, tooth disorder
Croatian: pogoršanje stanja, tresavica, edem lica, promjena boje jezika, žeđ, poremećaj zuba
English: You will again receive Temodal once daily for 5 days, followed by 23 days without Temodal.
Croatian: Ponovno ćete primati Temodal jedanput na dan tijekom 5 dana, nakon čega slijede 23 dana bez lijeka Temodal.
English: Hyperglycaemia
Croatian: hiperglikemija
English: Effective contraceptive precautions must be taken by both male and female patients who are taking Temodal (see also “Male fertility” below).
Croatian: I bolesnice i bolesnici koji uzimaju Temodal moraju primjenjivati učinkovite mjere kontracepcije (pogledajte i dio "Plodnost muškaraca" u daljnjem tekstu).
English: Temodal 2.5 mg/ml powder for solution for infusion delivers equivalent TMZ dose and exposure to both TMZ and its active metabolite MTIC as the corresponding Temodal hard capsules (see section 5.2).
Croatian: Primjenom lijeka Temodal 2,5 mg/ml prašak za otopinu za infuziju postižu se doza TMZ-a te izloženost TMZ-u i njegovu aktivnom metabolitu MTIC-u ekvivalentne onima koje se postižu odgovarajućom dozom
English: Temodal may make you feel tired or sleepy.
Croatian: Temodal može uzrokovati umor ili pospanost.
English: The other ingredients are mannitol (E421), threonine, polysorbate 80, sodium citrate (for pH-adjustment) and hydrochloric acid concentrated (for pH-adjustment) (see section 2).
Croatian: Drugi sastojci su manitol (E421), treonin, polisorbat 80, natrijev citrat (za podešavanje pH) i kloridna kiselina, koncentrirana (za podešavanje pH) (vidjeti dio 2).
English: TMZ is spontaneously hydrolyzed at physiologic pH primarily to the active species, 3-methyl(triazen-1-yl)imidazole-4-carboxamide (MTIC).
Croatian: TMZ se spontano hidrolizira pri fiziološkom pH prvenstveno u aktivni spoj 3-metil-(triazen1-il)imidazol-4-karboksamid (MTIC).
English: Uncommon side effects (may affect up to 1 in 100 people) are: - brain infections (meningoencephalitis herpetic) including fatal cases - new or reactivated cytomegalovirus infections - reactivated hepatitis B virus infections - secondary cancers including leukaemia - reduced blood cell counts (pancytopenia, anaemia, leukopenia) - red spots under the skin
Croatian: Manje česte nuspojave (mogu se javiti u do 1 na 100 osoba) su: - infekcije mozga (herpesni meningoencefalitis), uključujući slučajeve sa smrtnim ishodom - nove ili ponovno aktivirane infekcije citomegalovirusom - ponovno aktivirane infekcije virusom hepatitisa B
English: CTC non-haematological toxicity (except for alopecia, nausea, vomiting)
Croatian: CTC stupanj nehematološke toksičnosti (osim alopecije, mučnine i povraćanja)
English: Temodal 2.5 mg/ml powder for solution for infusion temozolomide
Croatian: Temodal 2,5 mg/ml prašak za otopinu za infuziju temozolomid
English: Effective contraceptive precautions must be taken by both male and female patients who are using Temodal (see also “Male fertility” below).
Croatian: I bolesnice i bolesnici koji primaju Temodal moraju primjenjivati učinkovite mjere kontracepcije (pogledajte i dio "Plodnost muškaraca" u daljnjem tekstu).
English: Mean Cmax values for TMZ and MTIC were 7.4 µg/ml and 320 ng/ml, respectively, following 90 minute intravenous infusion.
Croatian: Nakon 90-minutne intravenske infuzije prosječna vrijednost Cmax TMZ-a iznosila je 7,4 µg/ml, a MTIC-a 320 ng/ml.
English: Myopathy, muscle weakness, arthralgia, back pain, musculoskeletal pain, myalgia
Croatian: miopatija, mišićna slabost, artralgija, bol u leđima, bol u mišićima i kostima, mialgija
English: Diarrhoea, constipation, nausea, vomiting
Croatian: dijareja, konstipacija, mučnina, povraćanje
English: Intravenous use, single use only.
Croatian: Samo za primjenu u venu, za jednokratnu uporabu.
English: 9/l; thrombocyte count  100 x 10
Croatian: 9/l; broj trombocita  100 x 10
English: CTC Grade 2
Croatian: CTC stupnja 2
English: ANC falls to < 1.0 x 10
Croatian: Ako tijekom bilo kojeg ciklusa ABN padne na < 1,0 x 10
English: 9/l or the platelet count is < 50 x 10
Croatian: 9/l ili je broj trombocita < 50 x 10
English: During the monotherapy phase, the dose and way you receive Temodal in this phase will be different.
Croatian: Doza i način na koji ćete primati lijek Temodal u fazi monoterapije razlikovat će se od prethodne faze.
English: In patients previously untreated with chemotherapy, TMZ is administered at a dose of 200 mg/m 2 once daily for the first 5 days followed by a 23 day treatment interruption (total of 28 days).
Croatian: U bolesnika koji prethodno nisu liječeni kemoterapijom, TMZ se primjenjuje u dozi od 200 mg/m 2 jedanput na dan tijekom prvih 5 dana, nakon čega slijede 23 dana bez liječenja (ukupno 28 dana).
English: Fever, influenza-like symptoms, asthenia, malaise, pain, oedema, oedema peripheral i
Croatian: vrućica, simptomi nalik gripi, astenija, malaksalost, bol, edem, periferni edem
English: Local injection site adverse reactions, which were mostly mild and short-lived were reported in patients receiving Temodal 2.5 mg/ml powder for solution for infusion.
Croatian: U bolesnika koji su primali Temodal 2,5 mg/ml prašak za otopinu za infuziju prijavljene su lokalne nuspojave na mjestu injiciranja, koje su većinom bile blage i kratkotrajne.
English: In patients previously untreated with chemotherapy, TMZ is administered orally at a dose of 200 mg/m 2 once daily for the first 5 days followed by a 23 day treatment interruption (total of 28 days).
Croatian: U bolesnika koji prethodno nisu liječeni kemoterapijom, TMZ se primjenjuje peroralno u dozi od 200 mg/m 2 jedanput na dan tijekom prvih 5 dana, nakon čega slijede 23 dana bez liječenja (ukupno 28 dana).
English: Temodal hard capsules should be administered in the fasting state.
Croatian: Temodal tvrde kapsule moraju se uzimati natašte.
English: The reconstituted solution should not be used if discolouration or particulate matter is observed.
Croatian: Pripremljena otopina ne smije se upotrijebiti ako je promijenila boju ili sadrži vidljive čestice.
English: Cytotoxic lesions that develop subsequently are thought to involve aberrant repair of the methyl adduct.
Croatian: U nastanak citotoksičnih lezija vjerojatno je uključen poremećaj mehanizma za popravak metilne skupine.
English: Belgique/België/Belgien MSD Belgium BVBA/SPRL Tél/Tel: +32(0)27766211 dpoc_belux@merck.com
Croatian: België/Belgique/Belgien MSD Belgium BVBA/SPRL Tél/Tel: +32 (0)27766211 dpoc_belux@merck.com
English: 9/l; CTC non-haematological toxicity  Grade 1 (except for alopecia,
Croatian: 9/l; nehematološka toksičnost prema CTC  stupnju 1 (osim alopecije, mučnine i povraćanja).
English: Respiratory failure
Croatian: zatajenje jetre
English: Patients with newly-diagnosed glioblastoma multiforme:
Croatian: Bolesnici s novodijagnosticiranim multiformnim glioblastomom:
English: Your doctor will work out your exact dose.
Croatian: Liječnik će izračunati točnu dozu lijeka Temodal koja Vam je potrebna.
English: The cap is imprinted with “Temodal”.
Croatian: Na kapici je otisnut naziv "Temodal".
English: No infusion site other than a vein is acceptable.
Croatian: Lijek se ne smije primijeniti niti u jedno drugo mjesto osim u venu.
English: Adverse reactions in patients treated with temozolomide
Croatian: Tablica 4. Nuspojave u bolesnika liječenih temozolomidom
English: After reconstitution, use the solution within 14 hours at 25 C, including infusion time.
Croatian: Nakon pripreme, otopinu upotrijebiti u roku od 14 sati na temperaturi od 25°C, uključujući i vrijeme trajanja infuzije.
English: There were higher rates of Grade 4 neutropenia (ANC < 0.5 x 10
Croatian: U prvom ciklusu terapije učestalost neutropenije (ABN < 0,5 x 10
English: Do not take Temodal - if you are allergic to temozolomide or any of the other ingredients of this medicine (listed in section 6).
Croatian: Nemojte uzimati Temodal - ako ste alergični na temozolomid ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.). - ako ste imali alergijsku reakciju na dakarbazin (antitumorski lijek, poznat i kao DTIC).
English: Haemorrhage, embolism pulmonary, deep vein thrombosis, hypertension,
Croatian: krvarenje, plućna embolija, duboka venska tromboza, hipertenzija
English: Temodal 2.5 mg/ml powder for solution for infusion
Croatian: Temodal 2,5 mg/ml prašak za otopinu za infuziju
English: After reconstitution, 1 ml of solution for infusion contains 2.5 mg.
Croatian: Nakon pripreme, 1 ml otopine za infuziju sadrži 2,5 mg.
English: Cytotoxic Avoid contact with skin, eyes, nose.
Croatian: Citotoksično Izbjegavati kontakt s kožom, očima i nosom.