FrancophonIA/ELRC3.0 huggingface dataset:
English: Other significant adverse events leading to discontinuation of study medication for patients receiving pramipexole were confusional state, speech disorder and aggravated condition (see section 4.2).
Croatian: Druge značajne nuspojave u bolesnika na pramipeksolu, koje su dovele do prekida uzimanja ispitivanog lijeka, bile su konfuzno stanje,
English: PARTICULARS TO APPEAR ON IMMEDIATE PACKAGING UNITS Self-adhesive, paper label - Pramipexole Teva 0.35 mg Tablets
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE Samoljepljiva, papirnata naljepnica - Pramipeksol Teva 0,35 mg tablete
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Croatian: OTPADNIH MATERIJALA KOJI POTJEČU
English: White to off-white, oval, biconvex tablets, engraved with 9 vertical scoreline 3 on the scored side, and 8023 on the other side.
Croatian: Pramipeksol Teva 0,35 mg tablete Bijele do gotovo bijele, ovalne, bikonveksne tablete, s utisnutim 9 s jedne i 3 s druge strane vertikalnog razdjenog ureza na jednoj strani tablete te oznakom 8023 na drugoj strani tablete.
English: Restless Legs Syndrome
Croatian: Sindrom nemirnih nogu
English: 6 tablets Pramipexole Teva 0.088 mg
Croatian: 6 tableta Pramipeksol Teva 0,088 mg
English: 2 tablets Pramipexole Teva 0.088 mg
Croatian: 2 tablete Pramipeksol Teva 0,088 mg
English: Read the package leaflet before use
Croatian: Prije uporabe pročitajte uputu o lijeku.
English: 4 tablets Pramipexole Teva 0.088 mg
Croatian: 4 tablete Pramipeksol Teva 0,088 mg
English: PARTICULARS TO APPEAR ON IMMEDIATE PACKAGING UNITS self-adhesive, paper label - Pramipexole Teva 0.18 mg tablets
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE Samoljepljiva, papirnata naljepnica - Pramipeksol Teva 0,18 mg tablete
English: Posology
Croatian: PRILOG
English: Gastrointestinal disorders nausea constipation vomiting
Croatian: Poremećaji probavnog sustava mučnina konstipacij a povraćanje
English: Each tablet contains 0.5 mg pramipexole dihydrochloride monohydrate equivalent to 0.35 mg pramipexole.
Croatian: Jedna tableta sadrži 0,5 mg pramipeksoldiklorid hidrata što odgovara 0,35 mg pramipeksola.
English: Each tablet contains 0.125 mg pramipexole dihydrochloride monohydrate equivalent to 0.088 mg pramipexole.
Croatian: Jedna tableta sadrži 0,125 mg pramipeksoldiklorid hidrata što odgovara 0,088 mg pramipeksola.
English: PARTICULARS TO APPEAR ON IMMEDIATE PACKAGING UNITS self-adhesive, paper label - Pramipexole Teva 0.7 mg tablets
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE Samoljepljiva, papirnata naljepnica - Pramipeksol Teva 0,7 mg tablete
English: Each tablet contains 0.25 mg pramipexole dihydrochloride monohydrate equivalent to 0.18 mg pramipexole.
Croatian: Jedna tableta sadrži 0,25 mg pramipeksoldiklorid hidrata što odgovara 0,18 mg pramipeksola.
English: • Dizziness
Croatian: - nesvjestica
English: Each tablet contains 1 mg pramipexole dihydrochloride monohydrate equivalent to 0.7 mg pramipexole.
Croatian: Jedna tableta sadrži 1 mg pramipeksoldiklorid hidrata što odgovara 0,7 mg pramipeksola.
English: Tel: +386 15890390
Croatian: Pliva Ljubljana d.o.o. Tel: +386 15890390
English: Cardiac disorders cardiac failure1
Croatian: Srčani poremećaji zatajenje srca1
English: Uncommon may affect up to 1 in 100 people
Croatian: Manje često mogu se javiti u manje od 1 na 100 osoba
English: PARTICULARS TO APPEAR ON IMMEDIATE PACKAGING UNITS Self-adhesive, paper label -Pramipexole Teva 0.088 mg Tablets NAME OF THE MEDICINAL PRODUCT Pramipexole Teva 0.088 mg tablets Pramipexole
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE Samoljepljiva, papirnata naljepnica -Pramipeksol Teva 0,088 mg tablete
English: Do not stop taking Pramipexole Teva without first talking to your doctor.
Croatian: Teva bez prethodnog savjetovanja s Vašim liječnikom.
English: • Confusion
Croatian: • umor
English: 2 tablets Pramipexole Teva 0.18 mg
Croatian: 2 tablete Pramipeksola Teva 0,18 mg ILI
English: 1 tablet Pramipexole Teva 0.18 mg
Croatian: 1 tableta Pramipeksol Teva 0,18 mg ILI
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Teva B.V.
Croatian: 11. NAZIV I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET
English: Each tablet contains 1.0 mg pramipexole dihydrochloride monohydrate equivalent to 0.7 mg pramipexole.
Croatian: Jedna tableta sadrži 1,0 mg pramipeksoldiklorid hidrata, što odgovara 0,7 mg pramipeksola.
English: 1 tablet Pramipexole Teva 0.35 mg and 1 tablet Pramipexole Teva 0.18 mg
Croatian: 1 tableta Pramipeksol Teva 0,35 mg i 1 tableta
English: • Constipation
Croatian: • povraćanje
English: Pramipexole Teva 0.18 mg tablets EU/1/08/490/005
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/08/490/008
English: • Sleepiness
Croatian: • mučnina
English: Pramipexole Teva 0.35 mg tablets EU/1/08/490/009
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/08/490/004
English: Pramipexole Teva 0.7 mg tablets EU/1/08/490/013
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/08/490/016
English: Oral use.
Croatian: Kroz usta.
English: Hepatic impairment
Croatian: - Bolest bubrega
English: Sodium stearyl fumarate
Croatian: UAB Sicor Biotech
English: This is especially important
Croatian: To je posebno važno
English: - This medicine has been prescribed for you only.
Croatian: - Ovaj lijek propisan je samo Vama.
English: Always take steps to prevent exposure.
Croatian: Uvijek poduzmite mjere za sprječavanje izloženosti.
English: Via del Murillo Km 2.800 04013 Sermoneta Latina, Italy <{tel}> <{fax}> <{e-mail}>
Croatian: Via del Murillo Km 2.800 04013 Sermoneta Latina, Italija <{tel}> <{fax}> <{e-mail}>
English: The daily dose may sometimes be split to be taken morning and evening.
Croatian: Dnevna doza ponekad se može podijeliti za uzimanje ujutro i navečer.
English: Treatment is symptomatic.
Croatian: Liječenje je simptomatsko.
English: Not known (frequency cannot be estimated from the available data)
Croatian: Nepoznato (učestalost se ne može se procijeniti iz dostupnih podataka)
English: DO NOT take a double dose to make up for the forgotten dose.
Croatian: NEMOJTE uzeti dvostruku dozu kako biste nadoknadili zaboravljenu dozu.
English: Manufacturer Corden Pharma Latina S.p.A.
Croatian: Corden Pharma Latina S.p.A.
English: The dose you receive will be specific to you, which the doctor will calculate.
Croatian: Doza koju ćete primati bit će određena baš Vama, a izračunat će je liječnik.
English: Close monitoring of INR is recommended.
Croatian: Preporuča se pažljivo praćenje INR-a.
English: Similar toxicities can be expected with oral formulation.
Croatian: Slične toksičnosti mogu se očekivati s peroralnom formulacijom.
English: It is also present in human plasma, presumably as the trans isomer.
Croatian: Također je prisutan u ljudskoj plazmi, vjerojatno kao trans izomer.
English: These may be signs of a severe allergic reaction.
Croatian: To mogu biti znakovi teške alergijske reakcije.
English: These may cause allergic reactions (possibly delayed).
Croatian: Oni mogu uzrokovati alergijske reakcije (moguće i odgođene).
English: Detailed information on this medicinal product is available on the website of [name of MS Agency link].
Croatian: Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici [naziv poveznice Agencije države članice].
English: This product information is the outcome of the referral procedure to which this Commission decision relates.
Croatian: Ove informacije o lijeku ishod su arbitražnog postupka na koji se odnosi ova Odluka Komisije.
English: • changes in skin colour (pigmentation)
Croatian: • promjene boje kože (pigmentacije)
English: Handle with caution.
Croatian: Rukovati s oprezom.
English: Currently available data are described in section 5.2 but no recommendation on a posology can be made.
Croatian: Trenutno dostupni podaci opisani su u dijelu 5.2 međutim nije moguće dati preporuku o doziranju.
English: Blood tests will be taken at the start of your treatment, and before each dose you take, to make sure that this isn't happening.
Croatian: Krvne pretrage će se obaviti na početku liječenja i prije svake doze koju uzmete, kako bi se osiguralo da se ovo ne dogodi.
English: {Name and address} <{tel}> <{fax}> <{e-mail}>
Croatian: {Naziv i adresa} <{tel}> <{fax}> <{e-mail}>
English: Excipients with known effect:
Croatian: Pomoćne tvari s poznatim učinkom:
English: The doctor may sometimes prescribe a different dose particularly if you have kidney problems.
Croatian: Liječnik ponekad može propisati drukčiju dozu, pogotovo ako imate problema s bubrezima.
English: • severe allergic reactions
Croatian: • teške alergijske reakcije
English: Carcinogenic potential
Croatian: Kancerogeni potencijal
English: Most such adverse reactions are reversible if detected early.
Croatian: Većina tih nuspojava je reverzibilna ako se otkrije u ranoj fazi.
English: The product information may be subsequently updated by the Member State competent authorities, in liaison with the reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Croatian: Nadležna tijela država članica mogu naknadno ažurirati informacije o lijeku, gdje je prikladno u suradnji s referentnom državom članicom, u skladu s postupcima navedenim u Poglavlju 4 Glave III Direktive 2001/83/EZ.
English: • loss of appetite
Croatian: • gubitak apetita
English: • blood disorders (this is why you will be having blood tests between courses of treatment)
Croatian: • poremećaji krvi (zato ćete između ciklusa liječenja obavljati krvne pretrage)
English: Capsules should be taken on an empty stomach.
Croatian: Kapsule treba uzimati na prazan želudac.
English: Effective anti-cancer treatment can destroy cancer cells rapidly in large numbers.
Croatian: Učinkovito liječenje protiv raka može brzo uništiti veliki broj stanica raka.
English: Treatment should therefore be symptomatic and supportive, and patients should be closely monitored.
Croatian: Liječenje stoga treba biti simptomatsko i suportivno, a bolesnike se mora pažljivo nadzirati.
English: Bone marrow recovery is usually complete by day 20, and no cumulative toxicity has been reported.
Croatian: Potpuni oporavak koštane srži obično nastupa do 20. dana, a kumulativna toksičnost nije zabilježena.
English: In order to prevent this, your doctor will need to do regular blood tests to monitor the level of these substances during treatment with this medicine.
Croatian: Kako bi se to spriječilo, Vaš liječnik će trebati obavljati redovite krvne pretrage za praćenje razine tih tvari tijekom liječenja ovim lijekom.
English: • temporary hair loss
Croatian: • privremeni gubitak kose
English: In addition, men are advised to seek counselling on sperm preservation before starting treatment.
Croatian: Osim toga, muškarcima se preporučuje da se savjetuju oko pohrane sperme prije početka liječenja.
English: - if you have recently been given any live vaccines.
Croatian: - ako ste nedavno primili bilo kakva živa cjepiva.
English: Mutagenic potential
Croatian: Mutageni potencijal
English: - if you are taking any drugs with a similar mechanism of action as VEPESID.
Croatian: - ako uzimate bilo kakve lijekove sličnog mehanizma djelovanja kao VEPESID.
English: * Myelosuppression with fatal outcome has been reported **Seizure is occasionally associated with allergic reactions.
Croatian: *Prijavljena je mijelosupresija sa smrtnim ishodom **Napadaj je povremeno povezan s alergijskim reakcijama.
English: Appropriate preventive measures should also be considered in patients at risk of this complication of therapy.
Croatian: Također treba razmotriti odgovarajuće preventivne mjere u bolesnika s rizikom od ove terapijske komplikacije.
English: Stop taking the medicine and tell your doctor immediately if you get any of the following symptoms: swelling of your tongue or throat, breathing difficulties, fast heartbeat, flushing of the skin or a rash.
Croatian: Odmah prestanite uzimati lijek i obavijestite liječnika ako dobijete bilo koji od sljedećih simptoma: oticanje jezika ili grla, problemi s disanjem, ubrzano kucanje srca, crvenilo kože ili osip.
English: • increased bilirubin
Croatian: • povišeni bilirubin
English: Lactation (see section 4.6)
Croatian: Dojenje (vidjeti dio 4.6)
English: 75% of dose
Croatian: 75% doze
English: - If you have recently been given a live vaccine, including Yellow fever vaccine.
Croatian: - ako ste nedavno cijepljeni živim cjepivom, uključujući i cjepivo protiv žute groznice.
English: On very rare occasions this may cause harmful amounts of substances from these cancer cells to be released into the blood.
Croatian: To vrlo rijetko može uzrokovati otpuštanje štetnih količina tvari iz tih stanica raka u krvotok.
English: A specific antidote is not available.
Croatian: Nema raspoloživog specifičnog protulijeka.
English: Patients who experience such adverse reactions should be advised to avoid driving or using machines.
Croatian: Bolesnicima koji imaju takve nuspojave treba savjetovati da izbjegavaju vožnju i rad sa strojevima.
English: Given its mechanism of action, etoposide should be considered a possible carcinogen in humans.
Croatian: S obzirom na mehanizam djelovanja, etopozid treba smatrati potencijalno kancerogenim za ljude.
English: If you have reduced liver or kidney function, your doctor may also want you to take regular blood tests to monitor these levels.
Croatian: Ako imate smanjenu funkciju jetre ili bubrega, Vaš liječnik također može zatražiti da redovito obavljate krvne pretrage za praćenje tih razina.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Croatian: Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku ili ljekarniku za savjet prije nego što uzmete ovaj lijek.
English: Women of childbearing potential/Contraception in males and females
Croatian: Žene u reproduktivnoj dobi/Kontracepcija u muškaraca i žena
English: Myelosuppression is most often dose-limiting.
Croatian: Mijelosupresija najčešće ograničava dozu.
English: Recurrent or refractory testicular cancer
Croatian: Recidiv ili refraktorni rak testisa
English: rare dysgeusia, dysphagia
Croatian: rijetko disgeuzija, disfagija
English: There is increased risk of fatal systemic vaccinal disease with the use of yellow fever vaccine.
Croatian: Postoji povećan rizik od fatalne sistemske vakcinalne bolesti uslijed primjene cjepiva protiv žute groznice.
English: Neither the cumulative risk, nor the predisposing factors related to the development of secondary leukaemia are known.
Croatian: Nije poznat kumulativni rizik ni predisponirajući čimbenici povezani s razvojem sekundarne leukemije.
English: In vitro plasma protein binding is 97%.
Croatian: Vezivanje na proteine plazme in vitro je 97 %.
English: Metabolic Complications
Croatian: Metaboličke komplikacije
English: These adverse reactions presented by system organ class and frequency, which is defined by the following categories: very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1, 000, <1/100), rare (≥1/10, 000, <1/1,000), not known (cannot be estimated from the available data).
Croatian: Te nuspojave prikazane su prema klasifikaciji organskih sustava i učestalosti, koja se definira sljedećim kategorijama: vrlo često (≥1/10), često (≥1/100, <1/10), manje često (≥1/1000, <1/100), rijetko (≥1/10 000, <1/1000), nepoznato (učestalost se ne može procijeniti iz dostupnih podataka).
English: - If you are allergic to etoposide or any of the other ingredients of this medicine (listed in section
Croatian: - ako ste alergični na etopozid ili bilo koji drugi sastojak ovog lijeka (naveden u dijelu 6).
English: If this drug is used during pregnancy, or if the patient becomes pregnant while receiving this drug, the patient should be informed of the potential hazard to the fetus.
Croatian: Ako se ovaj lijek koristi tijekom trudnoće ili ako bolesnica zatrudni tijekom primanja ovog lijeka, treba je informirati o mogućoj opasnosti za plod.
English: Although minor differences in pharmacokinetic parameters between patients ≤65 years and >65 years of age have been observed, these are not considered clinically significant.
Croatian: Iako su zabilježene manje razlike farmakokinetičkih parametara kod bolesnika ≤65 godina i >65 godina, ne smatraju se klinički značajnima.
English: Infections and infestations not known infection
Croatian: Infekcije i infestacije nepoznato infekcija
English: Reversible alopecia, sometimes progressing to total baldness, was observed in up to 66% of patients treated with etoposide.
Croatian: Reverzibilna alopecija, ponekad uznapredovala to potpune ćelavosti, zabilježena je kod do 66% bolesnika liječenih etopozidom.
English: This includes appropriate equipment, such as wearing gloves and washing hands with soap and water after handling such products.
Croatian: To podrazumijeva prikladnu opremu, kao što je nošenje rukavica i pranje ruku sapunom i vodom nakon rukovanja ovim lijekovima.
English: The nausea and vomiting can usually be controlled by antiemetic therapy.
Croatian: Mučnina i povraćanje obično se mogu kontrolirati terapijom antiemeticima.
English: You should avoid touching the capsules by wearing gloves and wash your hands with soap and water after handling the medicine.
Croatian: Trebate izbjegavati dodirivanje kapsula nošenjem rukavica i pranjem ruku sapunom i vodom nakon rukovanja lijekom.
English: The safety and efficacy of VEPESID and associated names in children below 18 years of age have not been established.
Croatian: Sigurnost i djelotvornost primjene VEPESIDA i pridruženih imena u djece mlađe od 18 godina nije ustanovljena.
English: Take the empty container and any remaining capsules with you.
Croatian: Ponesite sa sobom praznu bočicu i preostale kapsule.
English: - if you are taking a medicine called ciclosporin (a drug used to reduce the activity of the immune system).
Croatian: - ako uzimate lijek pod nazivom ciklosporin (lijek koji smanjuje aktivnost imunološkog sustava).
English: Both male and female patients who are considering having a child after having treatment with VEPESID and associated names should discuss this with their doctor or nurse.
Croatian: I muški i ženski bolesnici koji razmišljaju o tome da imaju dijete nakon liječenja VEPESIDOM i pridruženim imenima, o tome se trebaju savjetovati sa svojim liječnikom ili medicinskom sestrom.
English: 100% of dose
Croatian: 100% doze
English: This medicine can cause a reduction in the level of some blood cells, which could cause you to suffer from infections, or may mean that your blood doesn't clot as well as it should if you cut yourself.
Croatian: Ovaj lijek može uzrokovati sniženje razine nekih krvnih stanica, što može dovesti do infekcija ili do toga da se Vaša krv ne zgrušava kako bi trebala ako se porežete.
English: The safety and effectiveness in paediatric patients has not been established.
Croatian: Nije utvrđena sigurnost i djelotvornost u pedijatrijskih bolesnika.
English: Increased within-patient variability in exposure may lead to greater variability in the dose-response relationship, i.e., leading to greater variability in patients' sensitivity to experience treatment-related toxicity from cycle to cycle, and potentially affecting overall efficacy of treatment in some patients.
Croatian: Povećana varijabilnost u izloženosti unutar pojedinog bolesnika može uzrokovati veću varijabilnost odnosa doza-odgovor, tj. dovesti do veće varijabilnosti u osjetljivosti bolesnika na toksičnosti povezane s liječenjem iz ciklusa u ciklus i potencijalno utjecati na ukupnu djelotvornost liječenja u nekih bolesnika.
English: In children, approximately 55% of the dose is excreted in the urine as etoposide in 24 hours.
Croatian: U djece se otprilike 55% doze izluči mokraćom u obliku etopozida u 24 sata.
English: In addition, O-demethylation of the dimethoxyphenol ring occurs through the CYP450 3A4 isoenzyme pathway to produce the corresponding catechol.
Croatian: Nadalje, O-demetilacija dimetoksifenolnog prstena događa se posredstvom CYP450 3A4 izoenzima da se stvori odgovarajući katehol.
English: Etoposide and its metabolites are not dialyzable.
Croatian: Etopozid i njegovi metaboliti ne mogu se dijalizirati.
English: No dosage adjustment is necessary in elderly patients (age > 65 years old), other than based on renal function (see section 5.2).
Croatian: Nije potrebna prilagodba doze za starije bolesnike (u dobi od > 65 godina), osim na osnovi bubrežne funkcije (vidjeti dio 5.2).
English: Although minor differences in pharmacokinetic parameters between genders have been observed, these are not considered clinically significant.
Croatian: Iako su zabilježene manje razlike farmakokinetičkih parametara među spolovima, ne smatraju se klinički značajnima.
English: No studies on the effects on the ability to drive and use machines have been performed.
Croatian: Nisu provedena ispitivanja učinaka na sposobnost upravljanja vozilima i rada sa strojevima.
English: VEPESID capsules are opaque pink, soft gelatin capsules.
Croatian: Kapsule VEPESIDA su neprozirne, ružičaste, meke želatinske kapsule.
English: The mean volumes of distribution at steady state fall in the range of 18 to 29 liters or 7 to 17 L/m2.
Croatian: Srednji volumeni distribucije u stanju dinamičke ravnoteže kreću se u rasponu od 18 do 29 litara ili 7 do 17 l/m2.
English: Co-administration of warfarin and etoposide may result in elevated international normalized ratio (INR).
Croatian: Istodobna primjena varfarina i etopozida može rezultirati povišenim međunarodnim normaliziranim omjerom (INR).
English: If this happens it can cause problems with the liver, kidney, heart or blood, which may result in death if not treated.
Croatian: Ako dođe do toga, to može uzrokovati probleme s jetrom, bubrezima, srcem ili krvlju, i ako se ne liječi može završiti smrću.
English: Procedures for proper handling and disposal of anti-cancer drugs should be followed.
Croatian: Potrebno je slijediti procedure za pravilno rukovanje i zbrinjavanje antitumorskih lijekova.
English: VEPESID and associated names must not be used during pregnancy unless clearly indicated by your doctor.
Croatian: VEPESID i pridružena imena ne smiju se koristiti tijekom trudnoće osim ako to jasno ne odredi Vaš liječnik.
English: • infection
Croatian: • infekcija
English: The exact reason why you have been prescribed VEPESID and associated names capsules is best discussed with your doctor.
Croatian: O pravom razlogu zašto su Vam propisane kapsule VEPESID i pridružena imena, najbolje se obratiti svom liječniku.
English: • increased liver enzymes
Croatian: • povišene vrijednosti jetrenih enzima
English: - if you have liver or kidney problems.
Croatian: - ako imate problema s jetrom ili bubrezima.
English: Microtubule assembly is not affected.
Croatian: Nema utjecaja na mikrotubularne strukture.
English: If severe reactions occur, the drug should be reduced in dosage or discontinued and appropriate corrective measures should be taken according to the clinical judgment of the physician.
Croatian: Ako dođe do teških nuspojava, treba smanjiti dozu lijeka ili prekinuti primjenu te treba poduzeti odgovarajuće korektivne mjere u skladu s kliničkom procjenom liječnika.
English: In case of curative intent the intravenous formulation should be used (see section 5.2).
Croatian: U slučaju kurativne namjene, treba primijeniti intravensku formulaciju (vidjeti dio 5.2).
English: OTHER SPECIAL WARNING(S), IF NECESSARY Cytotoxic.
Croatian: DRUGO(A) POSEBNO(A) UPOZORENJE(A), AKO JE POTREBNO Citotoksično.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister strip 50mg and 100mg
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP Blister strip 50mg i 100mg