FrancophonIA/ELRC3.0 huggingface dataset:
English: The median OS for patients with NSCLC other than predominantly squamous cell histology (n = 481) was 15.5 months for the pemetrexed arm and 10.3 months for the placebo arm, hazard ratio = 0.70 (95% CI = 0.56-0.88, p = 0.002).
Croatian: Medijan ukupnog preživljenja bolesnika s NSCLC-om kod kojega histološki ne prevladavaju skvamozne stanice (N = 481) bio je 15,5 mjeseci u skupini koja je primala pemetreksed i 10,3 mjeseca u skupini koja je primala placebo, omjer hazarda = 0,70 (95% CI = 0,56-0,88, p = 0,002).
English: Each 10 mL vial contains 100 mg of pemetrexed (as pemetrexed disodium hemipentahydrate).
Croatian: Svaka bočica od 10 ml sadrži 100 mg pemetrekseda (u obliku pemetrekseddinatrij hemipentahidrata).
English: CIAMBRA 100 mg: Each vial contains 100 milligrams of pemetrexed (as pemetrexed disodium hemipentahydrate).
Croatian: CIAMBRA 100 mg: jedna bočica sadrži 100 miligrama pemetrekseda (u obliku pemetrekseddinatrij hemipentahidrata).
English: Patients treated with pemetrexed and cisplatin required fewer transfusions (16.4% versus 28.9%, p<0.001), red blood cell transfusions (16.1% versus 27.3%, p<0.001) and platelet transfusions (1.8% versus 4.5%, p=0.002).
Croatian: p<0,001), transfuzija eritrocita (16,1% naspram 27,3%, p<0,001) i manje transfuzija trombocita (1,8%
English: Reconstitute 100 mg vials with 4.2 ml of sodium chloride 9 mg/ml (0.9 %) solution for injection, without preservative, resulting in a solution containing 25 mg/ml pemetrexed.
Croatian: Bočice od 100 mg rekonstituirajte sa 4,2 ml otopine natrijeva klorida za injekciju od 9 mg/ml (0,9%), bez konzervansa, čime se dobiva otopina koja sadrži 25 mg/ml pemetrekseda.
English: EU/1/15/1055/001
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/15/1055/001
English: - If you have any further questions, ask your doctor or pharmacist - If you get any side effects, talk to your doctor or pharmacist.
Croatian: Ako imate dodatnih pitanja, obratite se svome liječniku ili ljekarniku.
English: These criteria meet the National Cancer Institute Common Toxicity Criteria (CTC v2.0; NCI 1998) definition of ≥CTC Grade 2 bleeding
Croatian: 100% prethodne doze aZajednički kriteriji toksičnosti Nacionalnog instituta za rak (CTC v2.0; NCI 1998) Osim neurotoksičnosti
English: For the purpose of this table a cut off of 5 % was used for inclusion of all events where the reporter considered a possible relationship to pemetrexed and cisplatin.
Croatian: Za potrebe ove tablice, uključene su sve nuspojave čija je učestalost bila najmanje 5% i za koje je prijavitelj ocijenio da je moguća povezanost s pemetreksedom i cisplatinom.
English: Colitis (inflammation of the lining of the large bowel, which may be accompanied by intestinal or rectal bleeding)
Croatian: Upala sluznice jednjaka (ezofagusa) zamijećena je pri liječenju lijekom CIAMBRA/ zračenjem Kolitis (upala sluznice debelog crijeva koja može biti praćena krvarenjem iz crijeva ili završnog dijela debelog crijeva)
English: Liver: abnormal blood tests
Croatian: Bubreg: poremećeni nalazi krvnih pretraga
English: In both treatment arms, these chemonaive patients were fully supplemented with folic acid and vitamin B12.
Croatian: U obje skupine ti su bolesnici koji prethodno nisu primali kemoterapiju dobivali potpuni nadomjestak folatne kiseline i vitamina B12.
English: Sepsis, sometimes fatal, has been commonly reported during clinical trials with pemetrexed.
Croatian: Tijekom kliničkih ispitivanja pemetrekseda je često prijavljena sepsa, katkada sa smrtnim ishodom.
English: Reconstitute each 100 mg vial with 4.2 ml of 9 mg/ml (0.9%) sodium chloride solution for injection, without preservative, resulting in a solution containing 25 mg/ml pemetrexed.
Croatian: Svaku bočicu od 100 mg rekonstituirajte sa 4,2 ml otopine natrijeva klorida za injekciju od 9 mg/ml (0,9%), bez konzervansa, čime se dobiva otopina koja sadrži 25 mg/ml pemetrekseda.
English: Clinically relevant toxicity that was reported in < 1% of the patients that were randomly assigned to receive cisplatin and pemetrexed include: GGT increase, chest pain, arrhythmia, and motor neuropathy.
Croatian: Klinički značajne toksičnosti prema CTC kriterijima prijavljene u < 1% bolesnika randomiziranih da primaju cisplatin i pemetreksed uključuju: povišene vrijednosti GGT-a, bol u prsištu, aritmiju i motornu neuropatiju.
English: From the start of pemetrexed plus cisplatin first line induction treatment, the median OS of patients was 16.9 months for the pemetrexed arm and 14.0 months for the placebo arm (hazard ratio= 0.78, 95% CI= 0.64-0.96).
Croatian: Medijan ukupnog preživljenja od početka prve linije uvodnog liječenja pemetreksedom i cisplatinom iznosio je 16,9 mjeseci u skupini koja je primala pemetreksed te 14,0 mjeseci u skupini koja je primala placebo (omjer hazarda = 0,78; 95% CI= 0,64-0,96).
English: Clinically relevant CTC toxicities that were reported in ≥ 1 % and < 5 % of the patients that were randomly assigned to receive cisplatin and pemetrexed include: renal failure, infection, pyrexia, febrile neutropenia, increased AST, ALT, and GGT, urticaria and chest pain.
Croatian: Klinički značajne toksičnosti prema CTC kriterijima, prijavljene u ≥ 1% i < 5% bolesnika randomiziranih da primaju cisplatin i pemetreksed uključuju: zatajenje bubrega, infekciju, pireksiju, febrilnu neutropeniju, povišene vrijednosti AST-a, ALT-a i GGT-a, urtikariju i bol u prsištu.
English: Clinically relevant toxicity that was reported in ≥ 1% and ≤ 5% of the patients that were randomly assigned to receive cisplatin and pemetrexed include: AST increase, ALT increase, infection, febrile neutropenia, renal failure, pyrexia, dehydration, conjunctivitis, and creatinine clearance decrease.
Croatian: Klinički značajne toksičnosti prema CTC kriterijima, prijavljene u ≥ 1% i < 5% bolesnika randomiziranih da primaju cisplatin i pemetreksed uključuju: povišene vrijednosti AST-a, povišene vrijednosti ALT-a, infekciju, febrilnu neutropeniju, zatajenje bubrega, pireksiju, dehidraciju, konjunktivitis i smanjeni klirens kreatinina.
English: Any Grade 3 or 4 toxicities except mucositis
Croatian: Bilo koja toksičnost stupnja 3 ili 4,
English: FI Berlin-Chemie/A.Menarini Suomi OY Puh/Tel: +358 403 000 760
Croatian: FI Berlin-Chemie/A.Menarini Suomi OY Puh/Tel: +358 403 000 760 FR MENARINI France Tél: +33 (0)1 45 60 77 20
English: CIAMBRA is indicated as monotherapy for the second line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology (see section
Croatian: CIAMBRA je indicirana kao monoterapija u drugoj liniji liječenja bolesnika s lokalno uznapredovalim ili metastatskim rakom pluća nemalih stanica kod kojeg histološki ne prevladavaju skvamozne stanice (vidjeti dio 5.1).
English: An analysis of the impact of NSCLC histology on the treatment effect on overall survival was in favour of pemetrexed versus docetaxel for other than predominantly squamous histologies (n = 399, 9.3 versus 8.0 months, adjusted HR = 0.78; 95% CI = 0 .61-1.00, p = 0.047) and was in favour of docetaxel for squamous cell carcinoma histology (n = 172, 6.2 versus 7.4 months, adjusted HR = 1.56;
Croatian: Analiza utjecaja histologije NSCLC-a na učinak liječenja na ukupno preživljenje pokazala je prednost pemetrekseda u odnosu na docetaksel u tumora kod kojih histološki ne prevladavaju skvamozne stanice (N = 399; 9,3 naspram 8,0 mjeseci, prilagođeni omjer hazarda (engl. hazard ratio), HR = 0,78;
English: There is no relevant use of CIAMBRA in the paediatric population.
Croatian: Nije opravdana primjena lijeka CIAMBRA u djece i adolescenata.
English: CIAMBRA 500 mg powder for concentrate for solution for infusion Pemetrexed
Croatian: CIAMBRA 500 mg prašak za koncentrat za otopinu za infuziju pemetreksed
English: Each 50 mL vial contains 500 mg of pemetrexed (as pemetrexed disodium hemipentahydrate).
Croatian: Svaka bočica od 50 ml sadrži 500 mg pemetrekseda (u obliku pemetrekseddinatrij hemipentahidrata).
English: Cytotoxic
Croatian: CTCa stupanj
English: Hemoglobin decreased Neutrophils/ Granulocytes decreased Leukocytes Decreased Platelets Decreased
Croatian: Poremećaji krvi i limfnog sustava vrlo često sniženi hemoglobin sniženi broj neutrofila/ granulocita sniženi broj leukocita snižen broj trombocita
English: MARKETING AUTHORISATION HOLDER
Croatian: Nositelj odobrenja
English: A multicentre, randomised, double-blind, placebo-controlled Phase 3 study (PARAMOUNT), compared the efficacy and safety of continuation maintenance treatment with pemetrexed plus BSC (n = 359) with that of placebo plus BSC (n = 180) in patients with locally advanced (Stage IIIB) or metastatic (Stage IV) NSCLC other than predominantly squamous cell histology who did not progress after 4 cycles of first line doublet therapy of pemetrexed in combination with cisplatin.
Croatian: (PARAMOUNT) uspoređivala se djelotvornost i sigurnost liječenje pemetreksedom kao terapije održavanja uz BSC (N = 359) s djelotvornošću i sigurnošću primjene placeba uz BSC (N = 180) u bolesnika s lokalno uznapredovalim (stadij IIIB) ili metastatskim (stadij IV) NSCLC-om kod kojeg histološki ne prevladavaju skvamozne stanice, u kojih nije došlo do progresije nakon 4 ciklusa prve linije dvojne terapije pemetreksedom i cisplatinom.
English: DE Berlin-Chemie AG Tel: +49 (0) 30 67070
Croatian: CZ Berlin-Chemie/A.Menarini Ceska republika s.r.o. Tel: +420 267 199 333 DE Berlin-Chemie AG Tel: +49 (0) 30 67070
English: Oesophagitis / radiation oesophagitis has been uncommonly reported during clinical trials with pemetrexed.
Croatian: Tijekom kliničkih ispitivanja pemetrekseda ezofagitis/radijacijski ezofagitis je prijavljen manje često.
English: Pemetrexed is physically incompatible with diluents containing calcium, including lactated Ringer's injection and Ringer's injection This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Croatian: Pemetreksed je fizikalno inkompatibilan s otapalima koja sadrže kalcij, uključujući Ringerovu otopinu s laktatom i Ringerovu otopinu za injekcije.
English: Parenteral medicinal products must be inspected visually for particulate matter and discolouration prior to administration.
Croatian: Lijekovi za parenteralnu primjenu moraju se prije primjene vizualno pregledati kako bi se utvrdilo da ne sadrže čestice i da nisu promijenili boju.
English: EU/1/15/1055/002
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/15/1055/002
English: CIAMBRA 500 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU CIAMBRA 500 mg
English: CIAMBRA 100 mg powder for concentrate for solution for infusion Pemetrexed
Croatian: CIAMBRA 100 mg prašak za koncentrat za otopinu za infuziju pemetreksed
English: Unopened vial 3 years
Croatian: 3 godine
English: CIAMBRA 100 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU CIAMBRA 100 mg
English: Excipient with known effect Each vial contains approximately 11 mg sodium.
Croatian: Jedna bočica sadrži približno 11 mg natrija.
English: Binding was not notably affected by varying degrees of renal impairment.
Croatian: Različiti stupnjevi poremećaja bubrežne funkcije nisu znatnije utjecali na vezanje lijeka.
English: MT Menarini International Operations Luxembourg S.A. Tel: +352 264976
Croatian: MT Menarini International Operations Luxembourg S.A. Tel: +352 264976 NO Menarini International Operations Luxembourg S.A. Tlf: +352 264976
English: Grade
Croatian: Serija
English: For the purpose of this table, a cutoff of 5% was used for inclusion of all events where the reporter considered a possible relationship to pemetrexed.
Croatian: Za potrebe ove tablice, uključene su sve nuspojave čija je učestalost bila najmanje 5 % i za koje je prijavitelj ocijenio da je moguća povezanost s pemetreksedom.
English: (N = 222)
Croatian: cisplatin (N = 222)
English: Neutrophils/ Granulocytes decreased Leukocytes decreased Haemoglobin decreased Platelets decreased
Croatian: Poremećaji krvi i limfnog sustava vrlo često snižen broj neutrofila/ granulocita snižen broj leukocita snižene vrijednosti hemoglobina snižen broj trombocita
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION
Croatian: 1 bočica NAČIN I PUT(EVI) PRIMJENE LIJEKA
English: How to use CIAMBRA
Croatian: Kako primjenjivati lijek CIAMBRA Moguće nuspojave
English: Interstitial pneumonitis (scarring of the air sacs of the lung) Oedema (excess fluid in body tissue, causing swelling) Some patients have experienced a heart attack, stroke or “mini-stroke” while receiving CIAMBRA usually in combination with another anticancer therapy.
Croatian: Neki su bolesnici doživjeli srčani udar, moždani udar ili “mini moždani udar“ dok su primali lijek
English: Each vial contains 100 mg of pemetrexed (as pemetrexed disodium hemipentahydrate).
Croatian: Jedna bočica sadrži 100 mg pemetrekseda (u obliku pemetrekseddinatrij hemipentahidrata).
English: NSCLC, second-line treatment:
Croatian: Non small lung cancer, NSCLC), druga linija liječenja
English: CIAMBRA 500 mg powder for concentrate for solution for infusion
Croatian: NAZIV LIJEKA CIAMBRA 500 mg prašak za koncentrat za otopinu za infuziju
English: Each vial contains 500 mg of pemetrexed (as pemetrexed disodium hemipentahydrate).
Croatian: Jedna bočica sadrži 500 mg pemetrekseda (u obliku pemetrekseddinatrij hemipentahidrata).
English: Creatinine clearance decreased**
Croatian: Poremećaji bubrega****
English: CIAMBRA 100 mg powder for concentrate for solution for infusion
Croatian: NAZIV LIJEKA CIAMBRA 100 mg prašak za koncentrat za otopinu za infuziju
English: Name and address of the manufacturer responsible for batch release Oncotec Pharma Produktion GmbH Am Pharmapark
Croatian: 11. NAZIV I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Menarini International Operations Luxembourg S.A.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.There are also links to other websites about rare diseases and treatments.
Croatian: Tamo se također nalaze poveznice na druge internetske stranice o rijetkim bolestima i liječenjima istih.
English: Content Package size bottle (HDPE)
Croatian: Sastav Veličina pakovanja
English: bottle (HDPE) with child-resistant closure bottle (HDPE) with screw cap blister (alu/alu)
Croatian: 1000 mg Filmom obložena tableta
English: The long-term consequences of these events are currently unknown.
Croatian: Dugoročne posljedice tih događaja trenutno nisu poznate.
English: No fatalities occurred, and the patients recovered.
Croatian: Nije bilo smrtnih ishoda i bolesnici su se oporavili.
English: • This medicine has been prescribed for you or your child only.
Croatian: • Ovaj je lijek propisan samo Vama ili Vašem djetetu.
English: This is because it is very important not to be without the medicine, even for a short time.
Croatian: Vrlo je važno da ne ostanete bez lijeka, makar i na kratko.
English: Notes: The analysis is based on all available data.
Croatian: Napomene: Analiza se temelji na svim dostupnim podacima.
English: The observed half-life of elimination is 5 to 7 hours.
Croatian: Opaženi poluvijek eliminacije iznosi 5 do 7 sati.
English: Currently available data are described in sections 5.1 and 5.2.
Croatian: Trenutno dostupni podaci opisani su dijelovima 5.1 i 5.2.
English: If you forget to take a dose, take it as soon as you remember it.
Croatian: Ako zaboravite uzeti dozu lijeka, uzmite je čim se sjetite.
English: • This medicine can be taken with or without food or drink.
Croatian: • Ovaj lijek se može uzimati s hranom i pićem ili bez njih.
English: This means your body may fight infection better.
Croatian: To znači da se tijelo može bolje boriti s infekcijom.
English: It is not yet known what causes these changes, or whether they have any long-term effects.
Croatian: Još nije poznato što uzrokuje te promjene kao ni to jesu li njihovi učinci dugoročni.
English: Do not take DUTREBIS:
Croatian: Nemojte uzimati DUTREBIS:
English: 2 and above
Croatian: 2 ili više
English: Talk to your doctor if you notice changes in your body shape.
Croatian: Obratite se svom liječniku ako primijetite promjene u obliku tijela.
English: Talk to your doctor about other medicines you can take.
Croatian: Razgovarajte s liječnikom o drugim lijekovima koje možete uzimati.
English: If you do take too many tablets, contact your
Croatian: Ako uzmete previše tableta, javite se svom
English: Raltegravir has a relatively low genetic barrier to resistance.
Croatian: Raltegravir ima relativno nisku genetsku barijeru za rezistenciju.
English: Green, oval tablet, marked with "144" on one side.
Croatian: Zelena, ovalna tableta, s oznakom "144" na jednoj strani.
English: What DUTREBIS is and what it is used for
Croatian: Što je DUTREBIS i za što se koristi
English: After dose selection, additional patients were enrolled for evaluation of long term safety, tolerability and efficacy.
Croatian: Nakon odabira doze uključeni su dodatni bolesnici kako bi se procijenila dugoročna sigurnost, podnošljivost i djelotvornost.
English: • signs and symptoms of infection or inflammation
Croatian: • znakovi i simptomi infekcije ili upale
English: HIV infection is spread by contact with blood or sexual contact with a person with HIV.
Croatian: HIV infekcija prenosi se kontaktom sa zaraženom krvlju ili spolnim kontaktom s osobom zaraženom HIV-om.
English: The following drug interaction information is based on Geometric Mean values; the effect for an individual patient cannot be predicted precisely.
Croatian: Sljedeći podaci o interakcijama lijekova temelje se na vrijednostima geometrijskih sredina; ne može se precizno predvidjeti učinak na pojedinog bolesnika.
English: What you need to know before you take DUTREBIS
Croatian: Što morate znati prije nego počnete uzimati DUTREBIS
English: During a short break in taking the medicine, the amount of virus in your blood may increase.
Croatian: Naime, tijekom kratkog prekida uzimanja lijeka količina virusa u krvi može se povećati.
English: • increase your CD4-cell count (a type of white blood cell that plays an important role in maintaining a healthy immune system to help fight infection).
Croatian: • povećati broj CD4 stanica (vrste bijelih krvnih stanica koje imaju važnu ulogu u održavanju zdravog imunološkog sustava kako bi se mogao boriti protiv infekcije).
English: The tablets should be swallowed whole, without crushing or chewing.
Croatian: Tablete se moraju progutati cijele, bez lomljenja ili žvakanja.
English: BENCHMRK 1 and 2 Pooled
Croatian: Objedinjeni podaci BENCHMRK 1 i 2
English: The recommended dose is 1 tablet twice a day.
Croatian: Preporučena doza je 1 tableta dvaput na dan.
English: Pack size: 1 bottle containing 60 tablets.
Croatian: Veličina pakiranja: 1 boca sa 60 tableta.
English: Patients with HIV are at higher risk of developing cancer than patients without the disease.
Croatian: Bolesnici s HIV-om izloženi su većem riziku od razvoja raka nego oni koji ne boluju od te bolesti.
English: Severe skin and hypersensitivity reactions
Croatian: Teške kožne reakcije i reakcije preosjetljivosti
English: Lactic acidosis generally occurred after a few or several months of treatment.
Croatian: Laktacidoza se obično javljala nakon nekoliko ili više mjeseci liječenja.
English: Knowledge about the mechanism is incomplete.
Croatian: Poznavanje mehanizma djelovanja je nepotpuno.
English: Final dose population N=96
Croatian: Populacija koja je primala konačnu dozu N=96
English: It is believed that these symptoms are due to an improvement in the body's immune response, enabling the body to fight infections that may have been present with no obvious symptoms.
Croatian: Vjeruje se da su ti simptomi posljedica poboljšanog imunološkog odgovora koji omogućuje da se tijelo bori protiv infekcija koje su možda bile prisutne bez vidljivih simptoma.
English: Reducing the amount of HIV in the blood may improve the functioning of your immune system.
Croatian: Smanjenjem količine HIV-a u krvi može se poboljšati funkcioniranje Vašeg imunološkog sustava.
English: Similar findings were not observed in rabbits.
Croatian: Slični učinci nisu zapaženi na kunićima.
English: Always take this medicine exactly as your doctor, pharmacist or nurse has told you.
Croatian: Uvijek uzmite ovaj lijek točno onako kako su Vam rekli Vaš liječnik, ljekarnik ili medicinska sestra.
English: See section 4.4 regarding the need to administer raltegravir with another active agent.
Croatian: Vidjeti dio 4.4 za informacije o potrebi da se raltegravir primjenjuje s još jednim aktivnim lijekom.
English: Recommendations are based on available data from the individual components.
Croatian: Preporuke se temelje na dostupnim podacima o primjeni pojedinačnih komponenti.
English: These measures will help protect the
Croatian: Ove će mjere pomoći u očuvanju okoliša.
English: Biotransformation and excretion
Croatian: Biotransformacija i izlučivanje
English: You can still pass on HIV when taking this medicine, although the risk is lowered by effective therapy.
Croatian: HIV možete prenijeti čak i dok uzimate ovaj lijek, iako je tada rizik od prijenosa manji zbog učinkovite terapije.
English: It is important that you take DUTREBIS exactly as your doctor has instructed.
Croatian: Važno je da DUTREBIS uzimate točno onako kako Vas je uputio liječnik.
English: Advice on missed doses
Croatian: Savjet u slučaju propuštanja doze
English: • It is very important to take all your HIV medicines as prescribed and at the right times of day.
Croatian: • Vrlo je važno da sve lijekove za liječenje HIV-a uzimate pridržavajući se liječničkih uputa i u propisano doba dana.
English: However, it is not clear whether these cases were due to the ART or to the underlying HIV disease.
Croatian: Međutim, nije jasno jesu li ti slučajevi posljedica ART-a ili već postojeće HIV bolesti.
English: DUTREBIS tablets can be administered with or without food.
Croatian: DUTREBIS tablete mogu se primjenjivati s hranom ili bez nje.
English: These include cases of Stevens-Johnson syndrome and toxic epidermal necrolysis.
Croatian: One uključuju slučajeve Stevens-Johnsonovog sindroma i toksične epidermalne nekrolize.
English: DUTREBIS also helps stop the production of an enzyme called “HIV integrase”.
Croatian: DUTREBIS također pomaže zaustaviti stvaranje enzima koji se zove "HIV integraza".
English: The maximum dose is one tablet twice daily.
Croatian: Najviša doza je jedna tableta dvaput na dan.
English: Frequencies are defined as 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
Croatian: Učestalost pojavljivanja definirana je kao: 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).
English: After first opening of the medicinal product, the in-use shelf life is 30 days, below 30°C.
Croatian: Rok valjanosti nakon prvog otvaranja lijeka iznosi 30 dana, na temperaturi ispod 30C.
English: See a doctor immediately, if you notice any of the following: These are uncommon (may affect up to 1 in 100 people)
Croatian: Odmah se javite liječniku ako primijetite bilo što od sljedećeg: Ove su nuspojave manje česte (mogu se javiti u do 1 na 100 osoba):
English: Interaction not studied
Croatian: Interakcija nije ispitana.
English: 240 Weeks
Croatian: 240 tjedana
English: What DUTREBIS is and what it is used for What you need to know before you take DUTREBIS
Croatian: Što je DUTREBIS i za što se koristi Što morate znati prije nego počnete uzimati DUTREBIS
English: It can be life-threatening, and cause internal organs to fail.
Croatian: Može biti opasna po život i uzrokovati zatajenje unutarnjih organa.
English: Following oral administration, the mean time (tmax) to maximal serum concentrations (Cmax) is about an hour.
Croatian: Nakon peroralne primjene, srednja vrijednost vremena (tmax) do postizanja maksimalne serumske koncentracije (Cmax) iznosi oko jedan sat.
English: The initial dose finding stage included intensive pharmacokinetic evaluation.
Croatian: Početna faza utvrđivanja doze uključivala je intenzivnu farmakokinetičku procjenu.