FrancophonIA/ELRC3.0 huggingface dataset:
English: Using your index finger, move the coloured needle protector away from the needle.
Croatian: Kažiprstom povucite obojani štitnik igle od igle.
English: 60 1 ml syringes
Croatian: 60 štrcaljki volumena 1 ml
English: Contents of the pack and other information
Croatian: Sadržaj pakiranja i druge informacije Što Fuzeon sadrži
English: Each ml of reconstituted solution contains 90 mg enfuvirtide.
Croatian: Jedan ml rekonstituirane otopine sadrži 90 mg enfuvirtida.
English: OB alone regimen Per 100 patient years n (Total Exposure patient years) ALAT Gr. 3 (>5-10 x ULN) Gr. 4 (>10 x ULN) Haemoglobin Gr. 3 (6.5-7.9 g/dL) Gr. 4 (<6.5 g/dL) Creatinine phosphokinase Gr. 3 (>5-10 x ULN) Gr. 4 (>10 x ULN)
Croatian: ALT St. 3 (> 5-10 x GGN) St. 4 (> 10 x GGN) Hemoglobin
English: 60 vials with powder for solution for injection 60 vials with solvent
Croatian: 60 bočica s praškom za otopinu za injekciju 60 bočica s otapalom
English: Method of Administration
Croatian: Način primjene
English: Total prior ARVs ≤
Croatian: • upala gušterače
English: Roche Nederland B.V. Tel: +31 (0) 348 438050
Croatian: Tel: +31 (0) 348 438050
English: ● redness
Croatian: • svrbež
English: Eye disorders Common
Croatian: Poremećaji oka često konjunktivitis
English: Powder Vial:
Croatian: Otapalo Bočica:
English: Table 2 presents events seen at a higher rate among patients receiving Fuzeon + OB regimen than among patients on the OB alone regimen with an exposure adjusted increase of at least 2 patients with event per 100 patient-years.
Croatian: Navedeni su događaji s povećanjem prilagođenim u odnosu na izloženost od najmanje 2 bolesnika s nuspojavom na 100 bolesnik-godina.
English: METHOD AND ROUTE(S) OF ADMINISTRATION This water for injections is intended for the reconstitution of Fuzeon 90 mg/ml powder for solution for injection to obtain a solution for subcutaneous use
Croatian: Ova voda za injekcije namijenjena je za pripremu lijeka Fuzeon 90 mg/ml prašak za otopinu za injekciju kako bi se dobila otopina za potkožnu primjenu Prije uporabe pročitajte Uputu o lijeku
English: Roche s. r. o. Tel: +420 - 2 20382111
Croatian: Slovenská republika Roche Slovensko, s.r.o. Tel: +421 - 2 52638201
English: Vertigo
Croatian: Fuzeon
English: Roche
Croatian: Ishodi
English: 60 vials of Water for Injections that is used to reconstitute the Fuzeon powder 60 3 ml syringes
Croatian: 60 bočica lijeka Fuzeon 60 bočica s vodom za injekcije kojom se Fuzeon prašak priprema za primjenu
English: (see Table 6).
Croatian: (vidjeti dio 4.4).
English: Discontinued due to injection site reactions
Croatian: Stopa bolesnika koji su prekinuli liječenje zbog reakcija na mjestu injiciranja Vrsta događaja
English: NAME OF THE MEDICINAL PRODUCT Solvent for solution
Croatian: NAZIV LIJEKA
English: • decreased sensation
Croatian: • smanjen osjet
English: Sodium Carbonate, anhydrous Mannitol
Croatian: Prašak natrijev karbonat, bezvodni manitol natrijev hidroksid kloridna kiselina
English: Gastrointestinal disorders Common
Croatian: Tablični prikaz nuspojava
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING IMMEDIATE OUTER CARTON FOR FUZEON VIALS
Croatian: PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU PRIMARNA KUTIJA ZA BOČICE LIJEKA FUZEON
English: • nightmares
Croatian: • noćne more
English: Fuzeon +Optimised background a
Croatian: +optimizirana osnovna terapijaa
English: • kidney stones
Croatian: • bubrežni kamenci
English: Table 5 Outcomes of Randomised Treatment at Week 48 (Pooled Studies TORO 1 and TORO 2, ITT) Outcomes
Croatian: Tablica 5 Ishodi randomiziranog liječenja u 48. tjednu (objedinjeni podaci iz ispitivanja
English: METHOD OF ADMINISTRATION Read the package leaflet before use
Croatian: NAČIN PRIMJENE LIJEKA Prije uporabe pročitajte Uputu o lijeku.
English: Read the package leaflet before use
Croatian: Prije uporabe pročitajte Uputu o lijeku
English: Myalgia
Croatian: Nuspojava
English: Patients should be instructed on the use and administration of Fuzeon by a healthcare professional before using for the first time.
Croatian: Prije prve primjene zdravstveni djelatnik mora objasniti bolesniku kako se koristi i primjenjuje
English: 6.1 List of excipients
Croatian: FARMACEUTSKI PODACI 6.1 Popis pomoćnih tvari
English: Fuzeon 90 mg/ml powder and solvent for solution for injection Enfuvirtide
Croatian: Fuzeon 90 mg/ml prašak i otapalo za otopinu za injekciju enfuvirtid
English: Package leaflet: Information for the patient
Croatian: Tablica 1: Doziranje u pedijatrijskih bolesnika
English: Roche Slovensko, s.r.o.
Croatian: Česká republika Roche s. r. o.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Subcutaneous use
Croatian: NAČIN I PUT(EVI) PRIMJENE LIJEKA Za potkožnu primjenu
English: • muscle pain
Croatian: • upala sinusa
English: LIST OF EXCIPIENTS
Croatian: Opis odabranih nuspojava
English: Nasal congestion
Croatian: Prijavljivanje nuspojava
English: Other adverse reactions
Croatian: Ostale nuspojave
English: Table 1: Paediatric Dosing Weight (kg)
Croatian: Težina (kg)
English: Osteonecrosis:
Croatian: Osteonekroza:
English: feeling or being sick, sweating or shaking.
Croatian: • otvrdnuće kože ili kvržice • bol ili osjetljivost na dodir
English: • ear infection
Croatian: • infekcija uha • otečene žlijezde (limfni čvorovi)
English: To remove the clear plastic cap: • push towards the syringe and then pull the cap off.
Croatian: Da biste provjerili je li igla čvrsto pričvršćena na štrcaljku: - uhvatite plastičnu kapicu ispod štitnika igle - učvrstite iglu i kapicu tako da ih nježno zavrnete i potisnete prema štrcaljki.
English: Respiratory, thoracic and mediastinal disorders Common
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja često kongestija nosa
English: ARVs in their OB regimen were more likely to achieve a HIV-1 RNA of <400 copies/ml (or <50 copies/ml) on either treatment (see Table 6).
Croatian: Međutim, veću vjerojatnost za postizanje vrijednosti HIV-1 RNK < 400 kopija/ml (ili < 50 kopija/ml) u oba režima liječenja imali su bolesnici s početnim brojem CD4 stanica > 100 stanica/mm3, početnom vrijednošću HIV-1 RNK < 5,0 log10 kopija/ml, ≤ 10 prethodnih antiretrovirusnih lijekova i/ili aktivnih antiretrovirusnih lijekova OT režimu (vidjeti Tablicu 6).
English: Log Change from baseline (log10 copies/ml)*
Croatian: (log10 kopija/ml)*
English: Putting in the needle and injecting
Croatian: Pričvršćivanje igle i injiciranje 1.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Croatian: OZNAČAVANJE I UPUTA O LIJEKU
English: • tighten the needle and cap by slightly turning and pushing it towards the syringe.
Croatian: • potisnite je prema štrcaljki, a zatim povucite s igle.
English: • you are allergic to enfuvirtide or any of the other ingredients of this medicine (listed in section If you are not sure, talk to your doctor, pharmacist or nurse before using Fuzeon.
Croatian: • ako ste alergični na enfuvirtid ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: 0.9 ml 1.0 ml
Croatian: 1,0 ml
English: Withdrawal Rate due to ISRs Event Category
Croatian: Otapalo za parenteralnu primjenu
English: Any unused medicinal product should be disposed of in accordance with local requirements.
Croatian: 6.6 Posebne mjere za zbrinjavanje i rekonstitucija Neiskorišteni lijek valja zbrinuti sukladno lokalnim propisima.
English: ● bruises
Croatian: • žgaravica
English: Very common
Croatian: bol/ nelagoda
English: Roche Products (Ireland) Ltd. Tel: +353 (0) 1 469 0700
Croatian: Tel: +353 (0) 1 469 0700
English: Fuzeon + OB 90 mg bid (N=661)
Croatian: Fuzeon + OT 90 mg dvaput na dan
English: Conjunctivitis
Croatian: DODATAK
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Fuzeon 90 mg/ml powder for solution for injection Enfuvirtide
Croatian: Uputa o lijeku: Podaci za bolesnika Fuzeon 90 mg/ml prašak i otapalo za otopinu za injekciju enfuvirtid
English: If you get anyside effects, talk to your doctor, pharmacist or nurse.
Croatian: Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika, ljekarnika ili medicinsku sestru.
English: Lymphadenopathy
Croatian: • mučnina
English: PHARMACEUTICAL FORM AND CONTENTS Powder for solution for injection 60 vials with powder for solution for injection
Croatian: 60 bočica s praškom za otopinu za injekciju
English: • If you get any side effects, talk to your doctor, pharmacist or nurse.
Croatian: • Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika, ljekarnika ili medicinsku sestru.
English: • feeling sick
Croatian: • šećerna bolest
English: NAME OF THE MEDICINAL PRODUCT Fuzeon 90 mg/ml powder and solvent for solution for injection
Croatian: Fuzeon 90 mg/ml prašak i otapalo za otopinu za injekciju
English: NAME OF THE MEDICINAL PRODUCT Fuzeon 90 mg/ml powder for solution for injection Enfuvirtide
Croatian: Fuzeon 90 mg/ml prašak za otopinu za injekciju enfuvirtid
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 108 mg enfuvirtide.
Croatian: TVARI Jedna bočica sadrži 108 mg enfuvirtida.
English: Solvent Water for Injections
Croatian: NAZIV LIJEKA Otapalo za otopinu voda za injekcije
English: You may need to read it again.
Croatian: Možda ćete je trebati ponovo pročitati.
English: Toxicity was predictable and reversible.
Croatian: Toksičnost je bila predvidljiva i reverzibilna.
English: Further dilution is required.
Croatian: Potrebno je daljnje razrjeđivanje.
English: This can even be life threatening.
Croatian: To može biti čak opasno po život.
English: Survival (months)
Croatian: Preživljenje (mjeseci)
English: Reactions have been mild and have not generally required specific therapy.
Croatian: Reakcije su bile blage i općenito nisu zahtijevale specifičnu terapiju.
English: In some cases you may need a blood transfusion.
Croatian: U nekim slučajevima možda će biti potrebna transfuzija krvi.
English: It may harm them, even if their symptoms seem to be the same as yours.
Croatian: Može im naškoditi, čak i ako su njihovi znakovi bolesti jednaki Vašima.
English: • if you are pregnant or plan to become pregnant.
Croatian: • ako ste trudni ili planirate ostati trudni.
English: The clinical significance of this finding is unclear.
Croatian: Klinički značaj tog nalaza nije jasan.
English: Study 396
Croatian: Studija 396
English: This medicine is for single use only.
Croatian: Ovaj lijek je samo za jednokratnu upotrebu.
English: It may harm a baby conceived before, during or soon after treatment.
Croatian: Može naškoditi djetetu koje je začeto prije, tijekom ili ubrzo nakon liječenja.
English: If you feel tired or weak, do not drive or use machines.
Croatian: Ukoliko se osjećate umornim ili slabim, nemojte upravljati vozilom ili raditi sa strojevima.
English: Hycamtin is not recommended for pregnant women.
Croatian: Hycamtin se ne preporučuje trudnicama.
English: Study 065
Croatian: Studija 065
English: Before you are given this medicine your doctor needs to know:
Croatian: Prije nego što dobijete ovaj lijek, Vaš liječnik mora znati:
English: These measures will help to protect the environment.
Croatian: Ove će mjere pomoći u očuvanju okoliša.
English: Currently available data are described in sections 5.1 and 5.2 but no recommendation on a posology can be made.
Croatian: Trenutno dostupni podaci opisani su u dijelovima 5.1 i 5.2, međutim nije moguće dati preporuku o doziranju.
English: Ask your pharmacist how to dispose of medicines no longer required.
Croatian: Pitajte svog ljekarnika kako baciti lijekove koje više ne trebate.
English: Mean half-life increased from 1.9 hours to 4.9 hours.
Croatian: Srednji poluvijek se povećao s 1,9 sati na 4,9 sati.
English: [n = 9]) (see section 4.5).
Croatian: [n = 9]) (vidjeti dio 4.5).
English: No overall differences in effectiveness were observed between patients aged over 65 years and younger adult patients.
Croatian: Sveukupno nije primijećena razlika u učinkovitosti između bolesnika starijih od 65 godina i mlađih odraslih bolesnika.
English: If your partner becomes pregnant during your treatment, tell your doctor immediately.
Croatian: Ukoliko Vaša partnerica zatrudni tijekom Vašeg liječenja, odmah obavijestite liječnika.
English: UNIQUE IDENTIFIER - 2D BARCODE 2D barcode carrying the unique identifier included.
Croatian: JEDINSTVENI IDENTIFIKATOR - 2D BARKOD Sadrži 2D barkod s jedinstvenim identifikatorom.
English: Volume of distribution was slightly decreased and thus half-life only increased by 14%.
Croatian: Volumen distribucije je lagano smanjen i zbog toga je poluvijek povećan samo 14%.
English: Talk to your doctor for advice on how to minimise the risk of bleeding.
Croatian: Upitajte liječnika za savjet kako smanjiti rizik od krvarenja
English: Table 2 Study results Study GOG-0179
Croatian: Tablica 2 Rezultati ispitivanja GOG-0179
English: This increase is considered unlikely to be of clinical relevance.
Croatian: Smatra se da taj porast nije klinički značajan.
English: Overall, 87 complete and partial responses were observed, with 13 of these occurring during cycles 5 and 6 and 3 occurring thereafter.
Croatian: Sveukupno je zabilježeno 87 cjelokupnih i djelomičnih odgovora, od kojih se 13 javilo tijekom 5. i 6. ciklusa, a 3 nakon toga.
English: Total exposure (AUC) increases approximately proportionally with dose.
Croatian: Ukupna izloženost (AUC) raste približno proporcionalno dozi.
English: None known.
Croatian: Nisu poznate.
English: Each blister contains 10 capsules.
Croatian: Jedan blister sadrži 10 kapsula.
English: • the results of blood tests carried out before treatment
Croatian: • rezultata krvnih pretraga koje se provode prije liječenja
English: Store in a refrigerator (2ºC - 8ºC).
Croatian: Čuvati u hladnjaku (2C - 8C).
English: Just take the next dose at the scheduled time.
Croatian: Samo uzmite sljedeću dozu prema rasporedu doziranja.
English: • High body temperature (fever).
Croatian: • visoka tjelesna temperatura (vrućica)
English: 16 INFORMATION IN BRAILLE
Croatian: 16. PODACI NA BRAILLEOVOM PISMU
English: Do not try to become pregnant until a doctor advises you it is safe to do so.
Croatian: Nemojte pokušavati zatrudnjeti dok Vas liječnik ne savjetuje da je to sigurno.
English: Light yellow to greenish powder.
Croatian: Svijetlo žuti do zelenkasti prašak.
English: The median time to response in clinical studies was 7.6-11.6 weeks.
Croatian: Medijan vremena do odgovora u kliničkim ispitivanjima iznosio je 7,6 do 11,6 tjedana.
English: • Signs of infections: Hycamtin may reduce the number of white blood cells and lower your resistance to infection.
Croatian: • Znakovi infekcije: Hycamtin može smanjiti broj bijelih krvnih stanica i Vašu otpornost na infekciju.
English: Hycamtin capsules may be taken with or without food (see section 5.2).
Croatian: Hycamtin kapsule se mogu uzeti s ili bez hrane (vidjeti dio 5.2).
English: Rarely, it can lead to more severe bleeding (haemorrhage).
Croatian: Rijetko to može uzrokovati jače krvarenje (hemoragija).
English: Other medicines and Hycamtin
Croatian: Drugi lijekovi i Hycamtin
English: • if you are allergic to topotecan or any of the other ingredients of this medicine (listed in section 6).
Croatian: • ako ste alergični na topotekan ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
English: Your doctor will tell you whether this is the case, based on the results of your last blood test.
Croatian: Liječnik će zaključiti da li je to slučaj na temelju posljednjih nalaza krvnih pretraga.
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 (< 1/10,000) and not known (cannot be estimated from the available data).
Croatian: Učestalost je definirana 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) i nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Hycamtin helps to destroy tumours.
Croatian: Hycamtin pomaže pri uništavanju tumora.
English: • Staff should be trained to reconstitute the medicinal product.
Croatian: • Osoblje mora biti educirano za rekonstituciju lijeka.
English: Your doctor will determine the correct dose of cisplatin.
Croatian: Liječnik će odrediti odgovarajuću dozu cisplatina.
English: In addition, 5% of all patients treated (1% of courses) developed sepsis (see section 4.4).
Croatian: Nadalje, 5% svih liječenih bolesnika (1% ciklusa) je razvilo sepsu (vidjeti dio 4.4).
English: Taking out a capsule These capsules come in special packaging to prevent children removing them.
Croatian: Kapsule dolaze u posebnom pakiranju koje onemogućuje da ih djeca izvade.
English: Male patients who wish to father a child should ask their doctor for family planning advice or treatment.
Croatian: Bolesnici muškoga spola koji žele postati očevi moraju se savjetovati sa svojim liječnikom o planiranju obitelji ili liječenju.
English: 90429 Nuremberg Germany
Croatian: 90429 Nürnberg Njemačka
English: This pattern of treatment will normally be repeated every 3 weeks.
Croatian: Obično se ovakav ciklus liječenja ponavlja svaka 3 tjedna.
English: Topotecan also had a high volume of distribution, about 132 l (SD 57), and a relatively short half-life of 2-3 hours.
Croatian: Topotekan je također imao veliki volumen distribucije, oko 132 l (SD 57), te relativno kratak poluvijek od 2-3 sata.
English: Topotecan half-life was increased by about 30% but no clear change in volume of distribution was observed.
Croatian: Poluvijek topotekana povećao se oko 30% bez opaženih jasnih promjena u volumenu distribucije.
English: • This medicine has been prescribed for you.
Croatian: • Ovaj je lijek propisan samo Vama.
English: • your body size (surface area measured in square metres)
Croatian: • veličine Vašeg tijela (površina mjerena u kvadratnim metrima)
English: 10 capsules
Croatian: 10 kapsula
English: • the results of blood tests carried out before treatment The prescribed number of capsules should be swallowed whole, once a day for 5 days.
Croatian: • rezultata krvnih pretraga koje se provode prije liječenja Kapsule (propisani broj) je potrebno progutati cijele, jednom na dan tijekom 5 dana.
English: Infections and infestations Very common Infection Common
Croatian: Infekcije i infestacije Vrlo često infekcija
English: Do not restart breast-feeding until the doctor tells you it is safe to do so.
Croatian: Ne započinjite dojenje ponovno dok Vam liječnik ne kaže da je to sigurno.
English: 2, mucositis
Croatian: 2, mukozitis
English: If the capsules are punctured or leaking, you should immediately wash your hands thoroughly with soap and water.
Croatian: Ako su kapsule napuknute ili propuštaju, morate odmah dobro oprati ruke sapunom i vodom.
English: If you have more than 3 episodes of diarrhoea per day you should contact your doctor immediately.
Croatian: Ako imate više od 3 proljevaste stolice na dan odmah kontaktirajte svog liječnika.
English: Women of childbearing potential / Contraception in males and females
Croatian: Žene u generativnoj dobi / Kontracepcija u žena i muškaraca
English: This can lead to severe bleeding from relatively small injuries such as a small cut.
Croatian: Može se javiti ozbiljno krvarenje iz manjih ozljeda, kao što je posjekotina.
English: In this analysis, creatinine clearance was calculated using the Cockcroft-Gault method.
Croatian: U toj se analizi klirens kreatinina izračunavao na temelju Cockcroft-Gaultove metode.
English: Of the patients who received more than 6 cycles of therapy, 91% completed the study as planned or were treated until disease progression, with only 3% withdrawn for adverse events.
Croatian: Od bolesnica koje su primile više od 6 ciklusa liječenja, 91% je završilo sa sudjelovanjem u ispitivanju kako je i predviđeno, ili su liječene do progresije bolesti, uz samo 3% povučenih iz ispitivanja zbog pojave štetnih događaja.
English: Push out the capsule: gently push one end of the capsule through the foil layer.
Croatian: Istisnite kapsulu van: nježno gurnite jedan kraj kapsule kroz foliju.
English: In these studies there were no apparent differences in the pharmacokinetics of topotecan among children, adolescents and young adult patients with solid tumours or leukaemia, but data are too limited to draw definite conclusions.
Croatian: U tim ispitivanjima nije bilo očigledne razlike u farmakokinetici topotekana u djece, adolescenata i mlađih odraslih osoba sa solidnim tumorima ili leukemijom, ali podataka je premalo da bi se mogli izvesti konačni zaključci.
English: If you get the capsule contents in your eyes, wash them immediately with gently flowing water for at least 15 minutes.
Croatian: Ukoliko Vam sadržaj kapsule dospije u oči, odmah ih nježno isperite tekućom vodom kroz najmanje 15 minuta.
English: Topotecan was also evaluated in the paediatric population; however, only limited data on efficacy and safety are available.
Croatian: Topotekan je ispitivan i u dječjoj populaciji; međutim, dostupni su samo ograničeni podaci o njegovoj djelotvornosti i sigurnosti primjene.
English: Camberley, Surrey GU16 7SR United Kingdom
Croatian: Camberley, Surrey GU16 7SR Ujedinjeno Kraljevstvo
English: Reconstituted and diluted solutions
Croatian: Rekonstituirane i razrijeđene otopine
English: Anti-tumour activity was demonstrated primarily in patients with neuroblastoma.
Croatian: Antitumorsko djelovanje dokazano je prvenstveno u bolesnika s neuroblastomom.
English: • the disease being treated.
Croatian: • bolesti koja se liječi.
English: Consult your doctor after eye contact or if you experience a skin reaction.
Croatian: Posavjetujte se s liječnikom ako je došlo do kontakta s očima ili ako ste dobili kakvu kožnu reakciju.
English: What Hycamtin is and what it is used for
Croatian: Što je Hycamtin i za što se koristi
English: Similar results were obtained if glomerular filtration rate (ml/min) was estimated using the MDRD formula corrected for body weight.
Croatian: Slični rezultati dobiveni su i kada se brzina glomerularne filtracije (ml/min) procjenjivala na temelju MDRD formule korigirane za tjelesnu težinu.
English: Comparison of pharmacokinetic parameters did not suggest any change in pharmacokinetics over the 5 days of dosing.
Croatian: Usporedba farmakokinetičkih parametara nije ukazivala na promjene u farmakokinetici tijekom 5 dana doziranja.
English: The product should be used immediately after reconstitution as it contains no antibacterial preservative.
Croatian: Preporučuje se primjena neposredno nakon rekonstitucije s obzirom da ne sadrži antibakterijske konzervanse.
English: Remember to tell your doctor if you start to take any other medicines while you are on Hycamtin.
Croatian: Nemojte zaboraviti obavijestiti liječnika ako započinjete uzimati bilo koje druge lijekove dok traje liječenje lijekom Hycamtin.
English: The frequency of some side effects is not known (events from spontaneous reports and the frequency cannot be estimated from the available data):
Croatian: Učestalost nekih nuspojava nije poznata (događaji iz spontanih prijava te učestalost ne može biti utvrđena iz dostupnih podataka):
English: • advanced cervical cancer if surgery or radiotherapy treatment is not possible.
Croatian: • uznapredovalog raka vrata maternice ako kirurško liječenje ili zračenje nije moguće provesti.
English: You will have treatment once a day for 5 days.
Croatian: Liječenje ćete primati jednom dnevno tijekom 5 dana.
English: Topotecan is a substrate for both ABCB1 (P-glycoprotein) and ABCG2 (BCRP).
Croatian: Topotekan je supstrat i za ABCB1 (P-glikoprotein) i ABCG2 (BCRP).
English: Tell your doctor if you are taking, have recently taken, or might take any other medicines, including any herbal products or medicines obtained without a prescription.
Croatian: Obavijestite svog liječnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove, uključujući biljne pripravke, kao i lijekove koji se nabavljaju bez recepta.
English: Reconstitute before use.
Croatian: Pripremiti prije uporabe.
English: The treatment may vary, depending on the results of your regular blood tests.
Croatian: Način liječenja može se mijenjati ovisno o nalazima redovitih krvnih pretraga.
English: No studies of the effects on the ability to drive and use machines have been performed.
Croatian: Nisu provedena ispitivanja utjecaja na sposobnost upravljanja vozilima i rada sa strojevima.