FrancophonIA/ELRC3.0 huggingface dataset:
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, poznat i kao DTIC).
English: Tolerance to TMZ is similar to adults.
Croatian: Podnošljivost TMZ-a slična je onoj u odraslih bolesnika.
English: Your doctor will work out your exact dose.
Croatian: Vaš liječnik će izračunati točnu dozu koja Vam je potrebna.
English: What Temozolomide Sandoz is and what it is used for
Croatian: Što je Temozolomid Sandoz i za što se koristi
English: The half-life (t1/2) in plasma is approximately 1.8 hours.
Croatian: Poluvrijeme (t1/2) u plazmi iznosi približno 1,8 sati.
English: • allergic reaction
Croatian: 40. alergijska reakcija
English: If you vomit after taking your dose, do not take a second dose on the same day.
Croatian: Ako povratite nakon uzimanja doze, nemojte uzeti sljedeću dozu istoga dana.
English: CTC Grade 3 or 4
Croatian: CTC stupanj 3 ili 4
English: TMZ administration can be continued throughout the 42 day concomitant period (up to 49 days) if all of the following conditions are met:
Croatian: Davanje TMZ-a može se nastaviti tijekom 42 dana faze istodobnog liječenja (do najviše 49 dana) ako su zadovoljeni svi sljedeći uvjeti:
English: However, since TMZ does not undergo hepatic metabolism and exhibits low protein binding, it is unlikely that it would affect the pharmacokinetics of other medicinal products (see section 5.2).
Croatian: No budući da se TMZ ne metabolizira u jetri i da se slabo veže za proteine, nije vjerojatno da bi utjecao na farmakokinetiku drugih lijekova (vidjeti dio 5.2).
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: For patients on a 42 day treatment cycle liver function tests should be repeated midway during this cycle.
Croatian: U bolesnika na 42-dnevnom terapijskom ciklusu, pretrage funkcije jetre potrebno je ponoviti sredinom tog ciklusa.
English: Recurrent anaplastic astrocytoma
Croatian: Recidivirajući anaplastični astrocitom
English: In clinical trials, the most frequently occurring treatment-related undesirable effects were gastrointestinal disorders, specifically nausea (43 %) and vomiting (36 %).
Croatian: U kliničkim su ispitivanjima najčešće nuspojave povezane s liječenjem bile poremećaji probavnog sustava, preciznije mučnina (43 %) i povraćanje (36 %).
English: Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Croatian: Neiskorišteni lijek ili otpadni materijal valja zbrinuti sukladno lokalnim propisima.
English: Most haematologic adverse reactions were reported commonly or very commonly in both indications (Tables 4 and 5); the frequency of grade 3-4 laboratory findings is presented after each table.
Croatian: Većina hematoloških nuspojava prijavljena je često ili vrlo često u obje indikacije (tablice 4 i 5); iza svake tablice navedena je učestalost poremećaja laboratorijskih nalaza stupnja 3-4.
English: Detailed information on this medicine is available on the website of the European Medicines Agency (EMA) http://www.ema.europa.eu/
Croatian: Detaljnije informacije o ovom lijeku dostupne su na web stranici Europske agencije za lijekove (EMA) http://www.ema.europa.eu/.
English: Eesti filiaal Pärnu mnt 105
Croatian: Sandoz d.d. Eesti filiaal Pärnu mnt 105
English: Absolute neutrophil count
Croatian: Apsolutni broj neutrofila
English: There are reports of patients who have taken the recommended dose for more than 5 days of treatment (up to 64 days) with adverse events reported including bone marrow suppression, with or without infection, in some cases severe and prolonged and resulting in death.
Croatian: Prijavljeno je da su neki bolesnici uzimali preporučenu dozu dulje od pet dana liječenja (do 64 dana), pri čemu su prijavljene nuspojave obuhvaćale supresiju koštane srži, sa ili bez infekcije, koja je u nekim slučajevima bila teška i dugotrajna te završila smrću.
English: In the non-comparative trial, the PFS at 6 months was 19 %, the median progression-free survival was 2.1 months, and the median overall survival 5.4 months.
Croatian: U nekomparativnom ispitivanju je PFS nakon 6 mjeseci iznosio 19 %, medijan preživljenja bez progresije bolesti bio je 2,1 mjesec, a medijan ukupnog preživljenja 5,4 mjeseca.
English: Each bottle contains either 5 or 20 capsules.
Croatian: Svaka bočica sadrži 5 ili 20 kapsula.
English: The presence of thrombocytopenia may increase the risk of bleeding, and the presence of neutropenia or leukopenia may increase the risk of infection.
Croatian: Prisutnost trombocitopenije može povećati rizik od krvarenja, a prisutnost neutropenije ili leukopenije može povećati rizik od razvoja infekcije.
English: Contents of the pack and other information What Temozolomide Sandoz contains
Croatian: Sadržaj pakiranja i druge informacije Što Temozolomid Sandoz sadrži
English: Paediatric patients had a higher AUC than adult patients; however, the maximum tolerated dose (MTD) was 1,000 mg/m2 per cycle both in children and in adults.
Croatian: Pedijatrijski bolesnici imali su veći AUC nego odrasli bolesnici, no maksimalna podnošljiva doza iznosila je 1000 mg/m2 po ciklusu kako u djece, tako i u odraslih bolesnika.
English: Do not give this medicine to children under the age of 3 years because it has not been studied.
Croatian: Ovaj lijek nije ispitivan u djece mlađe od 3 godine te im ga stoga nemojte davati.
English: Herpes simplex, herpes zoster, influenza-like symptoms
Croatian: Herpes simplex, herpes zoster, simptomi nalik gripi
English: Each sachet contains 1 hard capsule.
Croatian: Svaka vrećica sadrži 1 tvrdu kapsulu.
English: If the dose was not escalated at Cycle 2, escalation should not be done in subsequent cycles.
Croatian: Ako se doza ne poveća u drugom ciklusu, u sljedećim se ciklusima ne smije povećavati.
English: Nausea and vomiting are very commonly associated with TMZ.
Croatian: Mučnina i povraćanje su vrlo često povezani s liječenjem TMZ-om.
English: Not known drug reaction with eosinophilia and systemic symptoms (DRESS)
Croatian: reakcija na lijek s eozinofilijom i sistemskim simptomima (DRESS)
English: Lymphopenia, petechiae
Croatian: Limfopenija, petehije
English: This is because temozolomide could cause hepatitis B to become active again, which can be fatal in some cases.
Croatian: To je zato što temozolomid može ponovno aktivirati hepatitis B, što u nekim slučajevima može imati smrtni ishod.
English: Convulsions, headache
Croatian: Konvulzije, glavobolja
English: The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) ) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines webportal.
Croatian: Nositelj odobrenja će periodička izvješća o neškodljivosti za ovaj lijek podnositi u skladu s referentnim popisom datuma EU (EURD popis) predviđenim člankom 107(c) stavkom 7 Direktive
English: In patients with prior chemotherapy a benefit was indicated in those with a KPS ≥ 80.
Croatian: Među bolesnicima koji su prethodno primali kemoterapiju korist se vidjela u onih koji su imali KPS ≥ 80.
English: Anorexia
Croatian: Anoreksija
English: The following side effects may occur, and may require medical attention.
Croatian: Mogu nastupiti sljedeće nuspojave zbog kojih Vam može trebati medicinska pomoć.
English: There is no clinical experience with use of TMZ in children under the age of 3 years.
Croatian: Nema kliničkog iskustva s primjenom TMZ-a u djece mlađe od 3 godine.
English: You may be given other medicines (anti-emetics) to take before and/or after taking Temozolomide Sandoz 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 Sandoz radi izbjegavanja ili kontrole mučnine i povraćanja.
English: Polyester/aluminium/polyethylene (PET/alu/PE) sachet.
Croatian: Vrećica od poliestera/aluminija/polietilena (PET/Al/PE).
English: If you take more Temozolomide Sandoz than you should
Croatian: Ako uzmete više Temozolomida Sandoz nego što ste trebali
English: For patients with significant liver function abnormalities, physicians should assess the benefit/risk of continuing treatment.
Croatian: U bolesnika sa značajnim odstupanjima od normalnih vrijednosti funkcije jetre, liječnici trebaju procijeniti omjer koristi/rizika za nastavak liječenja.
English: Toxicity
Croatian: Toksičnost
English: In a multicentre, prospective phase II trial evaluating the safety and efficacy of oral TMZ in the treatment of patients with anaplastic astrocytoma at first relapse, the 6 month PFS was 46 %.
Croatian: U multicentričnom prospektivnom ispitivanju faze II u kojemu se procjenjivala sigurnost i djelotvornost peroralno primijenjenog TMZ-a u liječenju bolesnika s prvim relapsom anaplastičnog astrocitoma, šestomjesečni PFS iznosio je 46 %.
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Croatian: Ako Vam je liječnik rekao da ne podnosite neke šećere, obratite se liječniku prije uzimanja ovog lijeka.
English: Temozolomide Sandoz treatment can cause a reduction in certain kinds of blood cells.
Croatian: Liječenje Temozolomidom Sandoz može izazvati smanjenje broja nekih vrsta krvnih stanica.
English: During treatment a complete blood count should be obtained on Day 22 (21 days after the first dose of TMZ).
Croatian: Kompletna krvna slika mora se napraviti 22. dana liječenja (21 dan nakon prve doze TMZ-a).
English: This led to hospitalisation and/or discontinuation of TMZ in 8 % and 4 %, respectively.
Croatian: To je dovelo do hospitalizacije i/ili obustave liječenja TMZ-om u 8 % odnosno 4 % bolesnika.
English: TMZ Dose (mg/m2/day)
Croatian: Doza TMZ-a (mg/m2/dan)
English: Review the dose with your doctor each time you start a new cycle, since it may be different from the last cycle.
Croatian: Svaki puta kada započinjete novi ciklus, provjerite s Vašim liječnikom dozu lijeka jer se ona može razlikovati od prethodnog ciklusa.
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: Do not use this medicine after the expiry date which is stated on the label and carton after EXP.
Croatian: Ovaj se lijek ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici i kutiji iza oznake „Rok valjanosti“/„EXP“.
English: Temozolomide Sandoz is used in these tumours if they return or get worse after standard treatment.
Croatian: U ovom slučaju se Temozolomid Sandoz koristi ako se tumor ponovno pojavio ili se pogoršava nakon standardne terapije.
English: SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
Croatian: POSEBNE MJERE ZBRINJAVANJA NEISKORIŠTENOG LIJEKA ILI OTPADNIH MATERIJALA KOJI POTJEČU
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 rijetki slučajevi jakog osipa s oticanjem kože, uključujući dlanove i tabane, ili bolnog crvenila kože i/ili mjehurića po tijelu ili u ustima.
English: TMZ demonstrates low protein binding (10 % to 20 %), and thus it is not expected to interact with highly protein-bound substances.
Croatian: TMZ se slabo veže za proteine (10 % do 20 %), pa se stoga ne očekuje da ulazi u interakcije s tvarima koje imaju visok afinitet vezanja za proteine.
English: No dose reductions are recommended, but delay or discontinuation of TMZ administration should be decided weekly according to haematological and non-haematological toxicity criteria.
Croatian: Ne preporučuje se smanjivanje doze lijeka, ali svakog tjedna treba odlučiti o odgodi ili prekidu primjene TMZ-a prema kriterijima hematološke i nehematološke toksičnosti.
English: If lymphopenia occurs, they are to continue the prophylaxis until recovery of lymphopenia to grade ≤ 1.
Croatian: Ako se razvije limfopenija, bolesnici moraju nastaviti s profilaksom sve do poboljšanja limfopenije do stupnja ≤ 1.
English: • severe headache that does not go away.
Croatian: zimice, jaku glavobolju koja ne prestaje.
English: (usual dose).You will take this dose every day for 42 days (up to 49 days) in combination with radiotherapy.
Croatian: Tu ćete dozu uzimati svakodnevno tijekom 42 dana (najdulje 49 dana) u kombinaciji sa zračenjem.
English: However, elderly patients (> 70 years of age) appear to be at increased risk of neutropenia and thrombocytopenia (see section 4.4).
Croatian: Ipak, čini se da je u starijih bolesnika (> 70 godina) povećan rizik od razvoja neutropenije i trombocitopenije (vidjeti dio 4.4).
English: Hypersensitivity to dacarbazine (DTIC).
Croatian: Preosjetljivost na dakarbazin.
English: The hazard ratio (HR) for overall survival was 1.59 (95 % CI for HR=1.33-1.91) with a log-rank p < 0.0001 in favour of the TMZ arm.
Croatian: Omjer hazarda (HR) za ukupno preživljenje iznosio je 1,59 (95 % CI za HR = 1,33-1,91), uz log-rang p < 0,0001 u korist skupine koja je primala TMZ.
English: TMZ is an embryotoxic, teratogenic and genotoxic alkylating agent.
Croatian: TMZ je embriotoksična, teratogena i genotoksična alkilirajuća tvar.
English: Anti-emetic therapy may be administered (see section 4.4).
Croatian: Mogu se primjenjivati antiemetici (vidjeti dio 4.4).
English: Patients receiving temozolomide in combination with radiotherapy may experience different side effects than patients taking temozolomide alone.
Croatian: Bolesnici koji uzimaju temozolomid u kombinaciji sa zračenjem mogu imati drugačije nuspojave od bolesnika koji uzimaju samo temozolomid.
English: • change in skin colour
Croatian: 30. promjena boje kože
English: The primary targets of toxicity included the bone marrow, lymphoreticular system, testes, the gastrointestinal tract and, at higher doses, which were lethal to 60 % to 100 % of rats and dogs tested, degeneration of the retina occurred.
Croatian: Toksični učinci primarno su zahvaćali koštanu srž, limforetikularni sustav, testise i probavni sustav, a pri većim dozama koje su bile letalne za 60 % do 100 % ispitanih štakora i pasa razvila se degeneracija mrežnice.
English: • if you have nausea (feeling sick in your stomach) and/or vomiting which are both very common side effects of Temozolomide Sandoz (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 Sandoz (pogledajte dio 4) liječnik Vam može propisati lijek koji sprečava povraćanje (antiemetik).
English: Rash, alopecia
Croatian: Osip, alopecija
English: In a population pharmacokinetics analysis of clinical trial experience there were 101 female and 169 male subjects for whom nadir neutrophil counts were available and 110 female and 174 male subjects for whom nadir platelet counts were available.
Croatian: U analizi populacijske farmakokinetike temeljenoj na podacima iz kliničkih ispitivanja, podaci o najnižem broju neutrofila bili su dostupni za 101 ženu i 169 muškaraca, a podaci o najnižem broju trombocita za 110 žena i 174 muškaraca.
English: Temozolomide Sandoz should not be administered to pregnant women.
Croatian: Temozolomid Sandoz ne smije se davati trudnicama.
English: Results of the Ames/salmonella and Human Peripheral Blood Lymphocyte (HPBL) chromosome aberration tests showed a positive mutagenicity response.
Croatian: Rezultati testa Ames/salmonela i testa kromosomskih aberacija u limfocitima periferne krvi čovjeka pokazali su pozitivan mutageni odgovor.
English: Temozolomide Sandoz contains lactose (a kind of sugar).
Croatian: Temozolomid Sandoz sadrži laktozu (vrstu šećera).
English: 5 days followed by 23 days without treatment.
Croatian: jedanput na dan tijekom 5 dana, nakon čega slijede 23 dana bez terapije.
English: Plasma clearance, volume of distribution and half-life are independent of dose.
Croatian: Klirens iz plazme, volumen raspodjele i poluvrijeme ne ovise o dozi.
English: Each hard capsule (capsule) is individually packed in a sachet.
Croatian: Vrećica Svaka tvrda kapsula je pojedinačno pakirana u vrećicu.
English: Very rare:
Croatian: Vrlo rijetko:
English: Male patients should use effective contraception and not father a child for up to 6 months after stopping treatment.
Croatian: Bolesnici muškog spola moraju primjenjivati učinkovitu kontracepciju te ne smiju pokušavati začeti dijete do šest mjeseci nakon prestanka liječenja.
English: Use of TMZ in combination with other myelosuppressive agents may increase the likelihood of myelosuppression.
Croatian: Primjena TMZ-a u kombinaciji s drugim mijelosupresivima može povećati vjerojatnost razvoja mijelosupresije.
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 (poput pneumonije uzrokovane s Pneumocystis jirovecii) i reaktivacija infekcija (poput HBV, CMV) su primijećene tijekom liječenja TMZ-om (vidjeti dio 4.8).
English: If use during pregnancy must be considered, the patient should be apprised of the potential risk to the foetus.
Croatian: Ako je nužno razmatrati mogućnost primjene ovog lijeka tijekom trudnoće, bolesnicu se mora upoznati s potencijalnim rizikom za plod.
English: myelodysplastic syndrome (MDS), secondary malignancies, including myeloid leukaemia
Croatian: mijelodisplastični sindrom (MDS), sekundarne zloćudne bolesti uključujući mijeloičnu leukemiju
English: The cytotoxicity of MTIC is thought to be primarily due to alkylation of DNA mainly at the O6 and N7 positions of guanine.
Croatian: Smatra se da je citotoksičnost MTIC-a prvenstveno posljedica alkilacije DNK većinom na položajima O6 i N7 gvanina.
English: A complete blood count should be obtained on Day 22 (21 days after the first dose) or within 48 hours of that day, and weekly until ANC > 1.5 x 109/l and platelet count > 100 x 109/l.
Croatian: Kompletna krvna slika mora se napraviti 22. dana (21 dan nakon prve doze) ili unutar 48 sati od tog dana, a zatim jednom tjedno sve dok ABN ne bude > 1,5 x 109/l, a broj trombocita > 100 x 109/l.
English: even if their signs of illness are the same as yours.
Croatian: Može im naškoditi, čak i ako su njihovi znakovi bolesti jednaki vašima.
English: In some cases, it may be necessary to stop treatment with Temozolomide Sandoz.
Croatian: U nekim će slučajevima možda biti neophodno prekinuti liječenje Temozolomidom Sandoz.
English: Co-administration with valproic acid was associated with a small but statistically significant decrease in clearance of TMZ.
Croatian: Istodobna primjena s valproičnom kiselinom bila je povezana s malim, no statistički značajnim smanjenjem klirensa
English: The colour of the capsule cap is different for each strength (see in the table below).
Croatian: Svaka jačina kapsule ima kapicu druge boje (vidjeti tablicu u nastavku).
English: What Temozolomide Sandoz looks like and contents of the pack
Croatian: Kako Temozolomid Sandoz izgleda i sadržaj pakiranja
English: In both trials, the primary endpoint was progression-free survival (PFS) defined by MRI scans or neurological worsening.
Croatian: U oba je ispitivanja primarna mjera ishoda bilo vrijeme preživljenja bez progresije bolesti (PFS), određeno nalazom magnetske rezonancije (MR) ili neurološkim pogoršanjem.
English: Once escalated, the dose remains at 200 mg/m2 per day for the first 5 days of each subsequent cycle except if toxicity occurs.
Croatian: Kad se jednom poveća, doza ostaje na razini od 200 mg/m2 na dan tijekom prvih 5 dana svakog sljedećeg ciklusa, osim u slučaju pojave toksičnih učinaka.
English: • change in taste.
Croatian: promjena osjeta okusa
English: Keep out of the sight and reach of children, preferably in a locked cupboard.
Croatian: Čuvati izvan pogleda i dohvata djece, najbolje u zaključanom ormariću.
English: Women of childbearing potential should be advised to use effective contraception to avoid pregnancy while they are receiving TMZ.
Croatian: Ženama u reproduktivnoj dobi treba savjetovati da koriste pouzdanu kontracepciju kako bi izbjegle trudnoću za vrijeme liječenja TMZ-om.
English: This medicinal product contains lactose.
Croatian: Ovaj lijek sadržava laktozu.
English: If ANC falls to < 1.0 x 109/l or the platelet count is < 50 x 109/l during any cycle, the next cycle should be reduced one dose level (see section 4.2).
Croatian: Ako tijekom bilo kojeg ciklusa ABN padne na < 1,0 x 109/l ili je broj trombocita < 50 x 109/l, u sljedećem se ciklusu doza mora sniziti za jednu razinu (vidjeti dio 4.2).
English: Pancytopenia, anaemia (grade 3-4), leukopenia
Croatian: Pancitopenija, anemija (stupanj 3-4), leukopenija
English: Cases of elevations of liver enzymes have been commonly reported.
Croatian: Često su prijavljeni slučajevi povišenja razina jetrenih enzima.
English: In some cases, exposure to concomitant medicinal products associated with aplastic anaemia, including carbamazepine, phenytoin, and sulfamethoxazole/trimethoprim, complicates assessment.
Croatian: U nekim slučajevima istodobna izloženost lijekovima povezanima s razvojem aplastične anemije, uključujući karbamazepin, fenitoin i sulfametoksazol/trimetoprim, otežava procjenu.
English: TMZ administration should be temporarily interrupted or permanently discontinued during the concomitant phase according to the haematological and non-haematological toxicity criteria as noted in Table 1.
Croatian: Primjena TMZ-a mora se privremeno prekinuti ili trajno obustaviti u fazi istodobnog liječenja ako se ispune kriteriji hematološke i nehematološke toksičnosti navedeni u Tablici 1.
English: Patients should be advised to keep capsules out of the sight and reach of children, preferably in a locked cupboard.
Croatian: Bolesniku treba savjetovati da kapsule čuva izvan pogleda i dohvata djece, najbolje u zaključanom ormariću.
English: Dose levels include 100 mg/m2, 150 mg/m2, and 200 mg/m2.
Croatian: Razine doza su 100 mg/m2, 150 mg/m2 i 200 mg/m2.
English: nausea, vomiting).
Croatian: mučnine i povraćanja).
English: Therefore, special care should be taken when TMZ is administered in elderly patients.
Croatian: Stoga je potreban osobit oprez kad se TMZ primjenjuje u starijih bolesnika.
English: Package leaflet: information for the user Temozolomide Sandoz 5 mg hard capsules Temozolomide Sandoz 20 mg hard capsules Temozolomide Sandoz 100 mg hard capsules Temozolomide Sandoz 140 mg hard capsules Temozolomide Sandoz 180 mg hard capsules Temozolomide Sandoz 250 mg hard capsules temozolomide
Croatian: Uputa o lijeku: Informacija za korisnika Temozolomid Sandoz 5 mg tvrde kapsule Temozolomid Sandoz 20 mg tvrde kapsule Temozolomid Sandoz 100 mg tvrde kapsule Temozolomid Sandoz 140 mg tvrde kapsule Temozolomid Sandoz 180 mg tvrde kapsule Temozolomid Sandoz 250 mg tvrde kapsule temozolomid
English: The hard capsules are dispensed in amber glass bottles (Type 3 glass) with polypropylene childresistant closures.
Croatian: Tvrde kapsule se nalaze u smeđim staklenim bočicama (staklo tipa 3) s polipropilenskim sigurnosnim zatvaračima za djecu.
English: However, caution should be exercised when TMZ is administered in these patients.
Croatian: potreban je oprez kad se TMZ primjenjuje u ovih bolesnika.
English: Symptoms of diabetes insipidus include passing a lot of urine and feeling thirsty.
Croatian: Simptomi insipidnog dijabetesa uključuju prekomjerno izlučivanje mokraće i pojačanu žeđ.