FrancophonIA/ELRC3.0 huggingface dataset:
English: The PSURs will include a separate review on drug interaction in the paediatric population and on the current and lost to follow up numbers in PASSs;
Slovenian: Redno posodobljena poročila o varnosti zdravila bodo vključevala poseben pregled interakcij z drugimi zdravili pri pediatrični populaciji ter trenutnih in izgubljenih podatkov za spremljanje številk v varnostnih študijah po izdaji dovoljenja za promet z zdravilom.
English: Patients received either latanoprost 0.005% once daily or timolol 0.5% (or optionally 0.25% for subjects younger than 3 years old) twice daily.
Slovenian: Bolniki so prejemali 0,005% latanoprost enkrat na dan ali 0,5 % timolol (ali po izbiri 0,25 % za osebe mlajše od 3 let) dvakrat na dan. Primarni opazovani dogodek je bil povprečno znižanje očesnega tlaka glede na izhodišče v 12. tednu študije.
English: 23-25 Avenue du Docteur Lannelongue 75014 Paris France
Slovenian: Lannelongue 75014 Paris France
English: In children from 0 to < 3 years old) that mainly suffers from PCG (Primary Congenital Glaucoma), surgery (e.g. trabeculotomy/goniotomy) remains the first line treatment.
Slovenian: Pri otrocih (starih od 0 do < 3 leta), ki imajo večinoma težave zaradi PCG (primarnega kongenitalnega glavkoma), ostaja kirurški poseg zdravljenje prvotnega izbora.
English: The non-PCG (e.g. juvenile open angle glaucoma, aphakic glaucoma) subgroup showed similar results as the PCG subgroup.
Slovenian: V ne-PCG podskupini (npr. juvenilni glavkom z odprtim zakotjem, afakični glavkom) so bili rezultati podobni kot v PCG podskupini.
English: Use Xalatan as instructed by your doctor, or the doctor treating your child until they tell you to stop.
Slovenian: Zdravilo Xalatan uporabljajte po navodilu svojega zdravnika ali zdravnika, ki zdravi vašega otroka, dokler vam zdravnik ne naroči, da nehajte.
English: Reduction of elevated intraocular pressure in paediatric patients with elevated intraocular pressure and paediatric glaucoma.
Slovenian: Znižanje povišanega očesnega tlaka pri pediatričnih bolnikih s povišanim očesnim tlakom in otroškim glavkomom.
English: BEFORE YOU USE {INVENTED NAME} {Invented name} can be used in adult men and women (including the elderly) and in children from birth to 18 years of age.
Slovenian: Zdravilo Xalatan se lahko uporablja pri odraslih moških in ženskah (vključno s starostniki), kot tudi pri otrocih od rojstva do 18. leta starosti.
English: - An estimation of the mean exposure to latanoprost expected in the PASS studies will be submitted; - The timelines for the submission of the full study A6111144 protocol; - Revised table summary of the EU RMP to reflect the PASS studies as additional
Slovenian: - predložena bo ocena pričakovane povprečne izpostavljenosti latanoprostu v varnostnih študijah po izdaji dovoljenja za promet z zdravilom; - časovne okvire za predložitev popolne študije protokola A6111144; - popravljeno zbirno preglednico načrta za obvladovanje tveganja EU, ki naj odraža varnostne študije po izdaji dovoljenja za promet z zdravilom kot dodatne farmakovigilenčne dejavnosti in interakcije zdravila kot manjkajoče informacije.
English: POSSIBLE SIDE EFFECTS Side effects seen more often in children compared to adults are runny itchy nose and fever.
Slovenian: Neželeni učinki, opaženi pogosteje pri otrocih v primerjavi z odraslimi, so izcedek iz nosu in srbeč nos ter zvišana telesna temperatura.
English: Pharmacia Ireland Limited
Slovenian: Pharmacia Ireland Xalatan
English: If you have any further questions, ask your doctor or the doctor treating your child or your pharmacist.
Slovenian: Če imate dodatna vprašanja, se posvetujte s svojim zdravnikom, z zdravnikom, ki zdravi vašega otroka ali s farmacevtom.
English: The next updated version of the DDPS should be submitted together with the 6-monthly Periodic Safety Updated Report (PSUR) due after the European Commission decision.
Slovenian: Naslednja posodobljena različica naj se predloži hkrati s šestmesečnim rednim posodobljenim poročilom o varnosti zdravila, ki ga je potrebno oddati po odločitvi Evropske komisije.
English: Table: IOP reduction (mmHg) at week 12 by active treatment group and baseline diagnosis Latanoprost N=53
Slovenian: Preglednica: Znižanje očesnega tlaka (mmHg) v 12. tednu v skupini z aktivnim zdravljenjem in diagnozo v izhodišču
English: Route of administration
Slovenian: NAVODILA ZA UPORABO
English: This should pass, but if you are worried contact your doctor or the doctor treating your child for advice.
Slovenian: To bo minilo, če pa ste zaskrbljeni, za nasvet vprašajte svojega zdravnika ali zdravnika, ki zdravi vašega otroka.
English: 04100 Latina - Italy
Slovenian: 04100 Latina - Italy kapljice za oči, raztopina
English: ANNEX II AMENDMENTS TO THE SUMMARY OF PRODUCT CHARACTERISTICS AND PACKAGE LEAFLET
Slovenian: DODATEK II DOPOLNILA POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA IN NAVODILA ZA UPORABO
English: Kennedy, L-1855 Luxembourg, G. D. of Luxembourg
Slovenian: Kennedy, L-1855 Luxembourg, G. D. of Luxembourg mikrogramov / ml kapljice za oči, raztopina
English: Talk to your doctor, or the doctor treating your child or your pharmacist before you take {Invented name} or before you give this to you child if you think any of the following apply to you or your child: If you or your child are about to have or have had eye surgery (including cataract surgery) If you or your child suffer from eye problems (such eye pain, irritation or inflammation, blurred vision) If you or your child suffers from dry eyes
Slovenian: - če boste imeli vi ali vaš otrok operacijo na očeh ali ste jo prestali (vključno z operacijo sive mrene), - če imate vi ali vaš otrok težave z očmi (kot so bolečina, draženje ali vnetje, zamegljen vid), - če imate vi ali vaš otrok težave zaradi suhih oči, - če imate vi ali vaš otrok hudo obliko astme ali če le-ta ni uravnana z zdravili, - če nosite vi ali vaš otrok kontaktne leče.
English: Xalatan 50 mikrogramov/ml kapljice za oko, raztopina
Slovenian: 50 mikrog/ ml kapljice za oči, raztopina
English: Taking other medicines {Invented name} may interact with other medicines.
Slovenian: Zdravilo Xalatan lahko medsebojno deluje z drugimi zdravili.
English: AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTIONS OF THE SUMMARY OF PRODUCT CHARACTERISTICS FOR XALATAN AND ASSOCIATED NAMES (as per Annex I)
Slovenian: DOPOLNILA, KI JIH JE POTREBNO VKLJUČITI V RELEVANTNA POGLAVJA POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA (na podlagi Dodatka I)
English: No data are available for preterm infants (less than 36 weeks gestational age).
Slovenian: Podatkov pri nedonošenih dojenčkih (rojeni prej kot v 36. tednu nosečnosti) ni na voljo.
English: p-value vs. timolol
Slovenian: p-vrednost proti timololu
English: AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTIONS OF THE PACKAGE LEAFLET FOR XALATAN AND ASSOCIATED NAMES (as per Annex I)
Slovenian: DOPOLNILA, KI JIH JE POTREBNO VKLJUČITI V RELEVANTNA POGLAVJA NAVODILA ZA UPORABO (na podlagi Dodatka I)
English: Mean IOP reductions in the latanoprost and timolol groups were similar.
Slovenian: Povprečno znižanje očesnega tlaka je bilo v skupinah z latanoprostom in timololom podobno.
English: The Netherlands microgram/ml
Slovenian: The Netherlands mikrogram/m l kapljice za oči, raztopina
English: Pfizer Luxembourg SARL, 51, Avenue J. F. Kennedy, L-1855 Luxembourg, Luxembourg
Slovenian: SARL, 51, Avenue J. F. Kennedy, L1855 Luxembourg, Luxembourg mikrogramov/ml kapljice za oko, raztopina raztopina
English: Take special care with {INVENTED NAME}
Slovenian: Bodite posebno pozorni pri uporabi zdravila Xalatan
English: {Invented name} has not been investigated in prematurely born infants (less than 36 weeks gestation).
Slovenian: Zdravilo Xalatan ni bilo raziskano pri nedonošenih dojenčkih (rojenih pred 36. tednom nosečnosti).
English: Contact lens wearers
Slovenian: Uporabniki kontaktnih leč
English: The median plasma elimination half-life was short (<20 minutes), similar for paediatric and adult patients, and resulted in no accumulation of latanoprost acid in the systemic circulation under steady-state conditions.
Slovenian: Srednja vrednost razpolovnega časa izločanja iz plazme je bila kratka (< 20 minut) in je bila podobna za pediatrične in odrasle bolnike.
English: Pfizer bv
Slovenian: Pfizer bv Rivium Westlaan
English: de Europa 20B Parque Empresarial la Moraleja
Slovenian: de Europa 20B
English: Non-PCG N=25
Slovenian: Ne-PCG N=25
English: Submission of a 6-monthly Period Safety Updated Report (PSUR) during the first 2 years following the European Commission decision and then after yearly;
Slovenian: V prvih dveh letih po odločitvi Evropske komisije je potrebno predložiti redno posodobljeno poročilo o varnosti zdravila vsakih šest mesecev, nato pa enkrat letno.
English: 0.005% w/v Eye drops, solution Ocular use
Slovenian: 0,05 mg/ml Eye drops, solutionTopikalna uporaba 2,5 ml
English: 0,005% Eye drops, solution Ocular use
Slovenian: 0,005% kapljice za oči, raztopina
English: CLINICAL PARTICULARS
Slovenian: Farmacevtska oblika
English: Week 12 Change from Baseline Mean†(SE)
Slovenian: Sprememba v 12. tednu od povprečja v izhodišču †(SN)
English: If you stop using {Invented name} You should speak to your doctor or the doctor treating your child if you want to stop taking Xalatan.
Slovenian: Če želite prenehati z jemanjem zdravila Xalatan se morate pogovoriti s svojim zdravnikom ali z zdravnikom, ki zdravi vašega otroka.
English: Baseline Mean (SE) Week 12 Change from Baseline Mean†(SE)
Slovenian: Povprečje v izhodišču (SN) Sprememba v 12. tednu od povprečja v izhodišču †(SN)
English: Non-PCG N=28
Slovenian: Ne-PCG N=28
English: You should check with your doctor, or the doctor treating your child or pharmacist if you are not sure.
Slovenian: Če ste negotovi, se posvetujte s svojim zdravnikom, z zdravnikom, ki zdravi vašega otroka ali s farmacevtom.
English: 5.1 Pharmacodynamic properties
Slovenian: FARMAKOLOŠKE LASTNOSTI 5.1 Farmakološke lastnosti
English: Pfizer AB
Slovenian: Pfizer AB Vetenskapsvagen
English: Contact your doctor as soon as possible if you or your child swallows {Invented name} accidentally.
Slovenian: Če vi ali vaš otrok pomotoma zaužijete zdravilo Xalatan, se obrnite na svojega zdravnika, takoj ko je to mogoče.
English: Date of first authorisation: 2 December 2015
Slovenian: Datum prve odobritve: 2. December 2015
English: The overall response rate was 14.1 %.
Slovenian: Povprečna stopnja odzivnosti je bila 14,1%.
English: ITT population and histology subgroups
Slovenian: ITT populacija in histološke podskupine
English: Event**
Slovenian: Dogodek**
English: * Definition of frequency terms: Very common - ≥ 10%; Common - > 5% and < 10%.
Slovenian: *Definicija pogostnosti: Zelo pogosto - ≥ 10%; Pogosto - > 5% in < 10%.
English: The primary efficacy analysis was based on the ITT population.
Slovenian: Prvotna analiza učinkovitosti je bila osnovana na ITT populaciji.
English: CIAMBRA may make you feel tired.
Slovenian: Zdravilo CIAMBRA lahko povzroči, da se boste počutili utrujene.
English: Rarely, skin reactions may be severe and could lead to death.
Slovenian: Redko so kožne reakcije lahko hude in lahko povzročijo smrt.
English: Calculate the dose and the number of CIAMBRA vials needed.
Slovenian: Izračunajte odmerek in število potrebnih vial zdravila CIAMBRA.
English: Between patient variability in clearance is moderate at 19.3 %.
Slovenian: Variabilnost med bolniki v očistku je zmerna, 19,3%.
English: Based on the planned date of your infusion of CIAMBRA and/or on the status of your kidney function, your doctor needs to advise you on which medicines you can take and when you can take them.
Slovenian: Na podlagi načrtovanega datuma vaše infuzije zdravila CIAMBRA in/ali glede na delovanje vaših ledvic, vam mora vaš zdravnik svetovati, katera zdravila lahko jemljete in kdaj jih lahko jemljete.
English: From a microbiological point of view, the infusion solution should be used immediately.
Slovenian: Z mikrobiološkega vidika je potrebno raztopino za infundiranje uporabiti nemudoma.
English: If you are pregnant, think you may be pregnant or are planning to have a baby,, tell your doctor.
Slovenian: Če ste noseči, menite, da bi lahko bili noseči ali načrtujete zanositev, to povejte svojemu zdravniku.
English: In vitro studies indicate that pemetrexed is approximately 81 % bound to plasma proteins.
Slovenian: Študije in vitro kažejo, da se približno 81% pemetrekseda veže na plazemske beljakovine.
English: The percentage of patients that received post study treatment was 64.3% for pemetrexed and 71.7% for placebo.
Slovenian: Odstotek bolnikov, ki so prejeli zdravljenje po študiji, je bil 64,3% za pemetreksed in 71,7% za placebo.
English: This is equivalent to 2,7% of the recommended maximum daily dietary intake of sodium for an adult.
Slovenian: To je ekvivalentno 2,7% priporočenega največjega dnevnega vnosa natrija s hrano pri odraslem.
English: Pemetrexed is primarily eliminated in the urine, with 70 % to 90 % of the administered dose being recovered unchanged in urine within the first 24 hours following administration.
Slovenian: Pemetreksed se primarno izloča z urinom, 70% do 90% danega odmerka najdemo nespremenjenega v urinu v prvih 24 urah po dajanju.
English: ITT population (N = 1725)
Slovenian: ITT populacija (N = 1725)
English: The 1 year and 2 year survival rates for patients on pemetrexed were 58% and 32% respectively, compared to 45% and 21% for patients on placebo.
Slovenian: Stopnji preživetja pri 1 in pri 2 letih pri bolnikih, ki so prejemali pemetreksed sta bili 58% in 32%, v primerjavi s 45% in 21% pri bolnikih, ki so prejemali placebo.
English: Side effects with CIAMBRA may include:
Slovenian: Neželeni učinki z zdravilom CIAMBRA lahko vključujejo:
English: If you are unsure, ask your doctor or pharmacist if any of your medicines are NSAIDs.
Slovenian: Če niste prepričani, vprašajte svojega zdravnika ali farmacevta, ali so katera od vaših zdravil NSAID.
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.
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu., kjer so na voljo tudi povezave do drugih spletnih strani o redkih boleznih in zdravljenju.
English: Your doctor will discuss with you the potential risk of taking CIAMBRA during pregnancy.
Slovenian: S svojim zdravnikom se pogovorite o možnem tveganju pri prejemanju zdravila CIAMBRA v času nosečnosti.
English: Very common side effects (may affect more than 1 in 10 people) Low white blood cells
Slovenian: Zelo pogosti neželeni učinki (pojavijo se lahko pri več kot 1 od 10 bolnikov) Nizko število belih krvnih celic
English: Response (n: qualified for response) Response rate (%) (95 % CI) Stable disease (%)
Slovenian: Odziv (n: ustrezen za odziv) Stopnja odzivnosti (%) (95% IZ) Stabilna bolezen (%)
English: Please tell your doctor if you are taking any medicine for pain or inflammation (swelling), such as medicines called “nonsteroidal anti-inflammatory drugs” (NSAIDs), including medicines purchased without a doctor's prescription (such as ibuprofen).
Slovenian: Prosimo, povejte svojemu zdravniku, če jemljete kaka zdravila proti bolečinam ali vnetju (oteklinam), denimo zdravila, imenovana “nesteroidna protivnetna zdravila” (NSAID), vključno z zdravili, ki ste jih dobili brez recepta (kot denimo ibuprofen).
English: Survival time (months) Median (m)
Slovenian: Čas preživetja (meseci) Mediana (m)
English: To reduce toxicity, patients treated with pemetrexed must also receive vitamin supplementation (see section 4.4).
Slovenian: Za zmanjšanje toksičnosti morajo bolniki, ki so zdravljeni s pemetreksedom, prejemati tudi dopolnila vitaminov (glejte poglavje 4.4).
English: Log Rank p-value*
Slovenian: Log Rank p-vrednosti*
English: Other medicines and CIAMBRA
Slovenian: Druga zdravila in zdravilo CIAMBRA
English: There are no data from the use of pemetrexed in pregnant women but pemetrexed, like other anti-metabolites, is suspected to cause serious birth defects when administered during pregnancy.
Slovenian: Podatkov o uporabi pemetrekseda pri nosečnicah ni, vendar za pemetreksed, kot za druge antimetabolite, sumimo, da povzroča resne prirojene okvare, če ga dajemo med nosečnostjo.
English: The efficacy analyses using PQ population are consistent with the analyses for the ITT population and support the non-inferiority of AC versus GC.
Slovenian: Analiza učinkovitosti z uporabo PK populacije je skladna z analizo ITT populacije in podpira prednost AC proti GC.
English: If concomitant administration of NSAIDs is necessary, patients should be monitored closely for toxicity, especially myelosuppression and gastrointestinal toxicity.
Slovenian: Če je sočasno dajanje NSAID potrebno, je pri bolnikih potrebno skrbno spremljati toksičnost, predvsem mieolosupresijo in gastrointestinalno toksičnost.
English: Subsequent vitamin B12 injections may be given on the same day as pemetrexed.
Slovenian: Kasnejše injekcije vitamina B12 so lahko dane isti dan kot pemetreksed.
English: The high intra-individual variability of the coagulation status during diseases and the possibility of interaction between oral anticoagulants and anticancer chemotherapy require increased frequency of INR (International Normalised Ratio) monitoring, if it is decided to treat the patient with oral anticoagulants.
Slovenian: Velika različnost med posamezniki v koagulacijskem statusu v času bolezni in možnost medsebojnega delovanja med peroralnimi antikoagulanti ter kemoterapijo proti raku zahtevata povečano pogostnost spremljanja INR (International Normalised Ratio), če se odločimo za zdravljenje bolnika s peroralnimi antikoagulacijskimi učinkovinami.
English: Kaplan Meier plots of overall survival by histology
Slovenian: Kaplan Meier graf skupnega preživetja glede na histologijo
English: The dose of CIAMBRA is 500 milligrams for every square metre of your body's surface area.
Slovenian: Odmerek zdravila CIAMBRA je 500 miligramov za vsak kvadratni meter površine vašega telesa.
English: At the time of this final survival analysis, 28.7% of patients were alive or lost to follow up on the pemetrexed arm versus 21.7% on the placebo arm.
Slovenian: V času te končne analize preživetja je bilo živih ali ni bilo na voljo za nadaljnje spremljanje 28,7% bolnikov v kraku pemetreksed v primerjavi z 21,7% v kraku s placebom.
English: Pemetrexed should not be used during pregnancy unless clearly necessary, after a careful consideration of the needs of the mother and the risk for the foetus (see section 4.4).
Slovenian: Pemetrekseda med nosečnostjo ne smemo uporabljati, če to ni neizogibno potrebno, uporabimo ga le po skrbni preučitvi potreb matere in tveganja za plod (glejte poglavje 4.4).
English: Pre-treatment with dexamethasone (or equivalent) can reduce the incidence and severity of skin reactions (see section 4.2).
Slovenian: Predhodno zdravljenje z deksametazonom (ali drugim enakovrednim kortikosteroidom) lahko zmanjša incidenco in resnost kožnih reakcij (glejte poglavje 4.2).
English: A total of 213 patients (48.3%) completed ≥ 6 cycles and a total of 103 patients (23.4%) completed ≥ 10 cycles of treatment with pemetrexed.
Slovenian: Skupno 213 bolnikov (48,3%) je zaključilo ≥ 6 ciklov in skupno 103 bolniki (23,4%) so zaključili ≥ 10 ciklov zdravljenja s pemetreksedom.
English: 06861 Dessau-Rosslau
Slovenian: 06861 Dessau-Rosslau Nemčija
English: OTHER SPECIAL WARNING(S), IF NECESSARY
Slovenian: DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA citostatik
English: You must contact your doctor immediately if you notice any of the following: Fever or infection: if you have a temperature of 38ºC or greater, sweating or other signs of infection (since you might have less white blood cells than normal).
Slovenian: Če opazite katerega od spodaj naštetih učinkov, morate nemudoma poklicati svojega zdravnika: Povišana telesna temperatura ali okužba: če se pojavi temperatura 38ºC ali višja, znojenje ali drugi znaki okužbe (ker imate lahko manj belih krvničk kot normalno).
English: Frequency estimate: Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1000 to<1/100), Rare (≥1/10,000 to<1/1000), Very rare (<1/10,000) and not known (cannot be estimated from available data).
Slovenian: Pogostnosti so določene kot: zelo pogosto (≥ 1/10), pogosto (≥ 1/100 do < 1/10), občasno (≥ 1/1.000 do < 1/100), redko (≥ 1/10.000 do < 1/1.000), zelo redko (< 1/10.000) in neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
English: The European Medicines Agency has waived the obligation to submit the results of studies with pemetrexed in all subsets of the paediatric population in the granted indications (see section 4.2).
Slovenian: Evropska agencija za zdravila je odstopila od obveze za predložitev rezultatov študij za pemetreksed za vse skupine pediatrične populacije za odobrene indikacije (glejte poglavje 4.2).
English: 95 % CI for median HR
Slovenian: 95% IZ za mediano RT
English: In clinical studies, patients with creatinine clearance of ≥ 45 ml/min required no dose adjustments other than those recommended for all patients.
Slovenian: V kliničnih študijah bolniki z očistkom kreatinina ≥ 45 ml/min niso potrebovali prilagajanja odmerkov, razen tistih prilagoditev, ki so priporočeni za vse bolnike.
English: Statistically significant for noninferiority, with the entire confidence interval for HR well below the 1.17645 noninferiority margin (p <0.001).
Slovenian: a Statistično pomembna za prednost, s celotnim intervalom zaupanja RT znatno pod 1,17645 mejo prednosti (p <0,001).
English: A total of 169 patients (47.1%) completed ≥ 6 cycles maintenance treatment with pemetrexed, representing at least 10 total cycles of pemetrexed.
Slovenian: Skupno je 169 bolnikov (47,1%) zaključilo ≥ 6 ciklov vzdrževalnega zdravljenja s pemetreksedom, kar predstavlja vsaj 10 polnih ciklov pemetrekseda.
English: Before each infusion you will have samples of your blood taken to evaluate if you have sufficient kidney and liver function and to check that you have enough blood cells to receive CIAMBRA.
Slovenian: Pred vsako infuzijo vam bomo odvzeli vzorce krvi za vrednotenje delovanja vaših ledvic in jeter ter oceno, ali imate dovolj krvnih celic za prejemanje zdravila CIAMBRA.
English: Men are advised not to father a child during and up to 6 months following treatment with CIAMBRA and should therefore use effective contraception during treatment with CIAMBRA and for up to 6 months afterwards.
Slovenian: Moškim odsvetujemo, da bi v času zdravljenja z zdravilom CIAMBRA ter do 6 mesecev po zdravljenju s tem zdravilom spočeli otroka, zato naj v času zdravljenja z zdravilom CIAMBRA ter do 6 mesecev po zdravljenju s tem zdravilom uporabljajo učinkovito kontracepcijo.
English: CIAMBRA is a medicine used in the treatment of cancer.
Slovenian: Zdravilo CIAMBRA je zdravilo, ki ga uporabljamo pri zdravljenju raka.
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, 4.2).
Slovenian: B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE Predpisovanje in izdaja zdravila je le na recept s posebnim režimom (glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2)
English: Large cell (N=153)
Slovenian: Velike celice (N=153)
English: 06861 Dessau-Roßlau Germany
Slovenian: 06861 Dessau-Roßlau Nemčija
English: If you have an accumulation of fluid around your lungs, your doctor may decide to remove the fluid before giving you CIAMBRA.
Slovenian: Če se vam okrog pljuč nabira tekočina, se bo vaš zdravnik morda odločil tekočino pred dajanjem zdravila CIAMBRA odstraniti.
English: If you have been recently vaccinated, please tell your doctor, as this can possibly cause bad effects with CIAMBRA.
Slovenian: Če ste bili nedavno cepljeni, prosimo, povejte to svojemu zdravniku saj lahko to ob jemanju zdravila CIAMBRA povzroča škodljive učinke.
English: Concomitant use contraindicated: Yellow fever vaccine: risk of fatal generalised vaccinale disease (see section 4.3).
Slovenian: Kontraindicirana sočasna uporaba: Cepivo proti rumeni mrzlici: tveganje za smrtno razširjeno bolezen po cepljenju (glejte poglavje 4.3).