FrancophonIA/ELRC3.0 huggingface dataset:
English: Extavia 250 microgram/ml powder for solution for injection interferon beta-1b
Croatian: Extavia 250 mikrograma/ml prašak za otopinu za injekciju interferon beta-1b
English: The solvent for Extavia is provided in a 2.25 ml pre-filled syringe and contains 1.2 ml sodium chloride 5.4 mg/ml (0.54% w/v) solution for injection.
Croatian: Otapalo za Extaviju nalazi se u napunjenoj štrcaljki volumena 2,25 ml i sadrži 1,2 ml otopine natrijevog klorida 5,4 mg/ml (0,54% m/V) za injekciju.
English: As for other beta interferons, severe liver damage, including cases of liver failure, have been reported rarely in patients taking Extavia.
Croatian: Kao što je slučaj i s drugim beta interferonima, rijetko su zabilježeni slučajevi teškog oštećenja jetre, uključujući slučajeve zatajenja jetre u bolesnika koji su uzimali Extaviju.
English: * ADRs derived only during post-marketing.
Croatian: *Nuspojave zabilježene samo nakon stavljanja lijeka u promet.
English: If the patient has multiple lesions Extavia should be discontinued until healing has occurred.
Croatian: Ako bolesnik ima višestruke lezije potrebno je prekinuti terapiju Extavijom dok lezije na zacijele.
English: The removable tip cap of the Extavia pre-filled syringe contains a derivative of natural rubber latex.
Croatian: Zatvarač vrha Extavia napunjene štrcaljke koji se može skinuti sadrži derivat prirodne lateks gume.
English: As for other beta interferons, cases of severe hepatic injury, including hepatic failure, have been reported in patients treated with Extavia.
Croatian: Kao i kod drugih beta interferona, zabilježeni su slučajevi teške ozljede jetre, uključujući i zatajenja jetre, u bolesnika liječenih Extavijom.
English: Additional caution should be exercised with any co-medication which has an effect on the haematopoetic system.
Croatian: Dodatan oprez potreban je prilikom istovremene primjene lijekova koji imaju učinak na krvotvorni sustav.
English: Secondary progressive multiple sclerosis: In some cases people with relapsing-remitting MS find that their symptoms increase and they progress to another form of MS called secondary progressive MS. With this, people find themselves becoming increasingly impaired, whether or not they have relapses.
Croatian: Sekundarno progresivna multipla skleroza: U nekim slučajevima osobe s relapsno remitirajućom multiplom sklerozom primjećuju da su im se simptomi pojačali te da njihova bolest prelazi u drugi oblik, takozvanu progresivnu multiplu sklerozu.
English: Rotation schedule
Croatian: Raspored promjene
English: The tip cap of the pre-filled syringe contains a derivative of natural rubber latex.
Croatian: Zatvarač vrha napunjene štrcaljke sadrži derivat prirodne lateks gume.
English: AREA 8
Croatian: PODRUČJE 8
English: Note: Do not shake the vial.
Croatian: Napomena: Ne tresite bočicu.
English: Hypertension °
Croatian: Hipertenzija
English: Injection site necrosis * °
Croatian: Nekroza na mjestu injiciranja * °
English: Bronchospasm* Pulmonary arterial hypertension**
Croatian: Plućna arterijska hipertenzija**
English: ► Flu-like symptoms such as fever, chills, painful joints, malaise, sweating, headache, or muscular pain.
Croatian: Simptomi nalik gripi kao što su vrućica, zimica, bolni zglobovi, opća slabost, znojenje, glavobolja ili bolovi u mišićima.
English: Extavia 250 microgram/ml powder and solvent for solution for injection interferon beta-1b
Croatian: Extavia 250 mikrograma/ml prašak i otapalo za otopinu za injekciju interferon beta-1b
English: The PSUR cycle of Extavia is aligned with the cross-referred product, Betaferon, until otherwise specified.
Croatian: Periodičnost PSUR-eva Extavije usklađena je s referentnim lijekom Betaferon, dok ne bude drugačije naznačeno.
English: Musculoskeletal and connective tissue disorders Hypertonia°
Croatian: Poremećaji mišićno-koštanog sustava i vezivnog tkiva Hipertonija°
English: 1 - Wash your hands thoroughly with soap and water before beginning this process.
Croatian: C) Priprema i izvlačenje otopine za injekciju, korak po korak 1 - Temeljito operite ruke sapunom i vodom prije početka tog postupka.
English: Stopping Extavia is not known to cause acute withdrawal symptoms.
Croatian: Nije poznato da prekid terapije Extavijom uzrokuje akutne simptome prekida primjene lijeka.
English: - painful periods (dysmenorrhoea), menstrual disorder, heavy uterine bleeding (metrorrhagia) especially between menstrual periods, impotence - injection site reaction (including redness, swelling, discolouration, inflammation, pain, allergic reaction, see section 2 “Warnings and precautions”), skin breakdown and tissue damage (necrosis) at injection site (see section 2 “Warnings and precautions”) - flu-like symptoms, fever, pain, chest pain, accumulation of fluid in arm, leg or face (peripheral oedema), lack/loss of strength (asthenia), chills, sweating, general feeling of being unwell.
Croatian: - reakcije na mjestu primjene (uključujući crvenilo, oticanje, promjenu boje, upalu, bol, alergijsku reakciju, pogledajte dio 2 „Upozorenja i mjere opreza“), propadanje kože i oštećenje tkiva (nekroza) na mjestu primjene (pogledajte dio 2 „Upozorenja i mjere opreza“) - simptomi nalik gripi, vrućica, bol, bol u grudnom košu, nakupljanje tekućine u ruci, nozi ili licu (periferni edem), nedostatak/gubitak snage (astenija), zimica, znojenje, opće loše osjećanje.
English: 7 - Discard the syringe in the disposal unit.
Croatian: 7 - Bacite štrcaljku u posudu za otpad.
English: EU/1/08/454/009 3-month multipack comprising 45 vials with powder and 45 pre-filled syringes with solvent EU/1/08/454/012 3-month multipack comprising 42 vials with powder and 42 pre-filled syringes with solvent EU/1/08/454/014 3-month multipack comprising 42 vials with powder and 45 pre-filled syringes with solvent
Croatian: EU/1/08/454/009 3-mjesečno višestruko pakiranje koje sadrži 45 bočica s praškom i 45 napunjenih štrcaljki s otapalom EU/1/08/454/012 3-mjesečno višestruko pakiranje koje sadrži 42 bočice s praškom i 42 napunjene štrcaljke s otapalom EU/1/08/454/014 3-mjesečno višestruko pakiranje koje sadrži 42 bočice s praškom i 45 napunjenih štrcaljki s otapalom
English: After reconstitution immediate use is recommended.
Croatian: Preporučuje se primijeniti odmah nakon rekonstitucije.
English: Do not use Extavia - if you are allergic to natural or recombinant interferon beta, human albumin or any of the other ingredients of this medicine (listed in section 6).
Croatian: Nemojte primjenjivati Extaviju - ako ste alergični na prirodni ili rekombinantni interferon beta, ljudski albumin ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.). - ako trenutačno patite od teške depresije i/ili misli o samoubojstvu (pogledajte dio „Upozorenja i mjere opreza“ i dio 4, „Moguće nuspojave“).
English: Symptoms include redness, swelling, change in skin colour, inflammation, pain, and hypersensitivity.
Croatian: Simptomi uključuju crvenilo, oticanje, promjenu boje kože, upalu, bol i preosjetljivost.
English: AREA 5
Croatian: PODRUČJE 5
English: - the number of red cells in the blood may fall (anaemia), - the thyroid gland does not work properly (too little hormone is produced) (hypothyroidism), - weight increase or decrease, - confusion, - abnormally rapid heartbeat (tachycardia), - a reddish yellow pigment (bilirubin), which is produced by your liver, may rise (this will show up in blood tests),
Croatian: - broj crvenih stanica u krvi mogao bi se smanjiti (anemija), - štitna žlijezda ne funkcionira kako treba (stvara se premalo hormona) (hipotireoidizam), - povećanje ili smanjenje tjelesne težine, - smetenost, - neuobičajeno brzi otkucaji srca (tahikardija) - crvenkastožuti pigment (bilirubin) kojeg stvara
English: 17 - Leave the needle cap on. You are now ready to manually inject yourself or to use the ExtaviPro 30G auto-injector for the administration of Extavia.
Croatian: Sada ste spremni za ručno injiciranje ili uporabu ExtaviPro 30G autoinjektora za primjenu Extavije.
English: Do not use any area where you can feel lumps, bumps, firm knots, pain or an area that is discoloured, indented, scabbed, or where the skin is broken.
Croatian: Izbjegavajte dijelove tijela na kojima osjećate izbočine, kvrge, tvrde čvorove, bol ili dijelove tijela koji su promijenili boju, koji su mlohavi, imaju kraste ili oštećenja kože.
English: The solvent is a clear/colourless solution.
Croatian: Otapalo je bistra/bezbojna otopina.
English: ► Common (may affect up to 1 in 10 people):
Croatian: ► Česte (mogu se javiti u do 1 na 10 osoba):
English: Attach it to the vial by pushing down until the vial adapter penetrates and locks around the top of the vial.
Croatian: Pričvrstite ga na bočicu tako da ga gurnete prema dolje dok nastavak za bočicu ne prodre kroz vrh bočice i učvrsti se oko njega.
English: Injection site reactions may occur less frequently if you use an auto-injector device.
Croatian: Reakcije na mjestu injiciranja rjeđe se događaju ako upotrebljavate autoinjektor.
English: • Choosing an injection site
Croatian: • Odabir mjesta injiciranja
English: Hypothyroidism
Croatian: Hipotiroidizam
English: - the number of platelets (which help the blood to clot) may fall (thrombocytopenia), - a certain type of blood fats (triglycerides) may increase (will show up in blood tests), see section 2 “Warnings and precautions”, - suicide attempts, - mood swings, - convulsion, - a specific liver enzyme (gamma GT) which is produced by your liver, may rise (this will show up in blood tests), - inflammation of the liver (hepatitis), - skin discolouration.
Croatian: (trombocitopenija), - određena vrsta masnoća u krvi (triglicerida) mogla bi se povećati (bit će vidljivo na krvnim pretragama), pogledajte dio 2 „Upozorenja i mjere opreza“, - pokušaj samoubojstva, - promjene raspoloženja, - konvulzije, - specifičan jetreni enzim (gama glutamiltransferaza) kojeg stvara
English: Events were reported at various time points during treatment and may occur after several years of treatment with interferon beta.
Croatian: Događaji su bili zabilježeni u različitim vremenskim točkama liječenja, a mogu se pojaviti i nekoliko godina nakon liječenja interferonom beta.
English: Extavia 250 microgram (Placebo) n=124 (n=123)
Croatian: Extavia 250 mikrogram a (Placebo) n=124 (n=123)
English: Skin and subcutaneous tissue disorders Skin disorder
Croatian: Poremećaji kože i potkožnog tkiva Poremećaji kože
English: if you experience symptoms like irregular heart beat, swelling such as of the ankles or legs, or shortness of breath.
Croatian: Ako osjetite simptome poput nepravilnih otkucaja srca, oticanja gležnjeva ili nogu, ili nedostatak zraka.
English: Extavia 250 microgram (Placebo) n=292 (n=176)
Croatian: Extavia 250 mikrogram a (Placebo) n=292 (n=176)
English: Extavia contains 300 microgram (9.6 million IU) of recombinant interferon beta-1b per vial*.
Croatian: Extavia sadrži 300 mikrograma (9,6 milijuna IU) rekombinantnog interferona beta-1b po bočici*.
English: 7 - Take out the pre-filled solvent syringe from its package.
Croatian: 7 - Izvadite napunjenu štrcaljku s otapalom iz pakovanja.
English: Corticosteroid or ACTH treatment of relapses for periods of up to 28 days has been well tolerated in patients receiving Extavia.
Croatian: Bolesnici koji primaju Extaviju dobro podnose liječenje relapsa kortikosteroidima ili s ACTH za razdoblja do 28 dana.
English: Extavia 250 microgram (Placebo) n=317 (n=308)
Croatian: Extavia 250 mikrograma (Placebo) n=317 (n=308)
English: Excipients:
Croatian: Napomena:
English: Capillary leak syndrome in preexisting monoclonal gammopathy*
Croatian: Anafilaktičke reakcije Sindrom sistemske povećane propusnosti kapilara kod već postojeće monoklonalne gamapatije*
English: Solvent for reconstitution of Extavia 1.2 ml sodium chloride solution 5.4 mg/ml
Croatian: Otapalo za pripremu otopine lijeka Extavia za primjenu 1,2 ml otopine natrijevog klorida 5,4 mg/ml
English: The other ingredients are in the powder: mannitol and human albumin.
Croatian: Drugi sastojci su u prašku: manitol i ljudski albumin. u otapalu: natrijev klorid, voda za injekciju.
English: 1 vial contains 300 microgram (9.6 million IU) interferon beta-1b.
Croatian: 1 bočica sadrži 300 mikrograma (9,6 milijuna IU) interferona beta-1b.
English: How Extavia works
Croatian: Kako Extavia djeluje
English: Extavia 250 microgram (Placebo) n=360 (n=358)
Croatian: Extavia 250 mikrogram a (Placebo) n=360 (n=358)
English: AREA 3
Croatian: PODRUČJE 3
English: Cardiomyopathy*
Croatian: Kardiomiopatija*
English: • Alcohol swabs
Croatian: • Tupfere natopljene alkoholom
English: How to store Extavia
Croatian: Kako primjenjivati Extaviju
English: 4 - Peel back and remove the cover from the vial adapter packaging.
Croatian: 4 - Odlijepite i skinite pokrov s pakiranja nastavka za bočicu.
English: ROTATION SCHEDULE:
Croatian: RASPORED PROMJENE MJESTA PRIMJENE:
English: ► Uncommon (may affect up to 1 in 100 people):
Croatian: ► Manje česte (mogu se javiti u do 1 na 100 osoba):
English: Extavia contains sodium
Croatian: Extavija sadrži natrij
English: After reconstitution, each millilitre contains 250 microgram (8.0 million IU) interferon beta-1b.
Croatian: Nakon pripreme za primjenu svaki mililitar sadrži 250 mikrograma (8,0 milijuna IU) interferona beta-1b.
English: AREA 7
Croatian: PODRUČJE 7
English: - infection, abscess - reduced number of white blood cells, swollen lymph glands (lymphadenopathy) - decrease in the amount of sugar in the blood (hypoglycaemia) - depression, anxiety - headache, dizziness, sleeplessness, migraine, numbness or tingling feeling (paraesthesia) - eye inflammation (conjunctivitis), abnormal vision - ear pain - irregular, rapid beating or pulsation of the heart (palpitation) - redness and/or facial flushing due to widening of blood vessels(vasodilation), increased blood pressure (hypertension) - runny nose, cough, hoarseness due to infection of the upper respiratory tract, sinusitis, cough increased, shortness of breath (dyspnoea) - diarrhoea, constipation, nausea, vomiting, abdominal pain - rises in the blood levels of liver enzymes (will show up in blood tests) - skin disorder, rash - muscle stiffness (hypertonia), painful muscles (myalgia), muscular debility (myasthenia), back pain, pain in extremities such as fingers and toes - holding urine (urinary retention), protein in the urine (will show up in urine tests), urinary frequency, inability to hold back urination (urinary incontinence), urinary urgency
Croatian: - infekcija, apsces - sniženi broj bijelih krvnih stanica, otečeni limfni čvorovi (limfadenopatija) - smanjenje količine šećera u krvi (hipoglikemija) - depresija, tjeskoba - glavobolja, omaglica, nesanica, migrena, osjećaj obamrlosti ili trnjenja (parestezije) - upala spojnice oka (konjunktivitis), poremećaji vida - bol u uhu - nepravilni, ubrzani otkucaji ili osjećaj lupanja srca (palpitacija) - crvenilo i/ili navale crvenila u licu zbog širenja krvnih žila (vazodilatacija), povišeni krvni tlak
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA NAPUNJENE ŠTRCALJKE
English: Malaise *
Croatian: Dispneja *
English: A) General advice
Croatian: A)
English: 3-month multipack containing 42 (3x14) vials of interferon beta-1b and 42 (3x14) pre-filled syringes containing solvent.
Croatian: - 3-mjesečno višestruko pakiranje koje sadrži 42 (3x14) bočice interferona beta-1b i 42 (3x14) napunjene štrcaljke koje sadrže otapalo.
English: 1 ml contains 250 microgram (8.0 million IU) interferon beta-1b when reconstituted.
Croatian: 1 ml sadrži 250 mikrograma (8,0 milijuna IU) interferona beta-1b nakon pripreme otopine za primjenu.
English: 8 - Holding the vial and adapter securely, screw the syringe fully onto the vial adapter.
Croatian: 8 - Čvrsto držeći bočicu i nastavak, pričvrstite štrcaljku na nastavak za bočicu tako da je do kraja navijete.
English: 3-month multipack: 42 (3 packs of 14) vials with powder and 42 (3 packs of 14) pre-filled syringes with 1.2 ml solvent.
Croatian: 3-mjesečno višestruko pakiranje: 42 (3 pakiranja od po 14) bočica s praškom i 42 (3 pakiranja od 14) napunjenih štrcaljki s 1,2 ml otapala.
English: Uncommon (1/1,000 to
Croatian: Manje često (1/1000 i
English: 3-month multipack: 45 (3 packs of 15) vials with powder and 45 (3 packs of 15) pre-filled syringes with 1.2 ml solvent.
Croatian: 3-mjesečno višestruko pakiranje: 45 (3 pakiranja od po 15) bočica s praškom i 45 (3 pakiranja od 15) napunjenih štrcaljki s 1,2 ml otapala.
English: 3-month multipack containing 45 (3x15) vials of interferon beta-1b and 45 (3x15) pre-filled syringes containing solvent.
Croatian: - 3-mjesečno višestruko pakiranje koje sadrži 45 (3x15) bočica interferona beta-1b i 45 (3x15) napunjenih štrcaljki koje sadrže otapalo.
English: AREA 2
Croatian: PODRUČJE 2
English: 15 - Unscrew the syringe, leaving the vial adapter on the vial.
Croatian: 15 - Odvijte štrcaljku, ali nastavak ostavite na bočici.
English: 5 vials with powder and 5 pre-filled syringes with 1.2 ml solvent.
Croatian: 5 bočica s praškom i 5 napunjenih štrcaljki s 1,2 ml otapala.
English: Do not remove the vial adapter from its packaging.
Croatian: Ne vadite nastavak za bočicu iz pakovanja.
English: After reconstitution, each ml contains 250 microgram (8.0 million IU) of recombinant interferon beta1b.
Croatian: Nakon rekonstitucije, jedan ml sadrži 250 mikrograma (8,0 milijuna IU) rekombinantnog interferona beta-1b.
English: White blood cell count decreased (<3000/mm³)
Croatian: Smanjeni broj leukocita (<3000/mm³)
English: 3-month multipack containing 42 (3x14) vials of interferon beta-1b and 45 (3x15) pre-filled syringes containing solvent.
Croatian: - 3-mjesečno višestruko pakiranje koje sadrži 42 (3x14) bočice interferona beta-1b i 45 (3x15) napunjenih štrcaljki koje sadrže otapalo.
English: 9 - Hold the syringe-vial assembly at a slight angle.
Croatian: 9 - Držite sklop štrcaljke i bočice pod blagim kutem.
English: Each vial contains 300 microgram (9.6 million IU) interferon beta-1b per vial.
Croatian: Svaka bočica sadrži 300 mikrograma (9,6 milijuna IU) interferona beta-1b po bočici.
English: 14 vials with powder and 14 pre-filled syringes with 1.2 ml solvent.
Croatian: 14 bočica s praškom i 14 napunjenih štrcaljki s 1,2 ml otapala.
English: One controlled clinical trial was performed with Extavia in patients with relapsing-remitting multiple sclerosis and able to walk unaided (baseline EDSS 0 to 5.5).
Croatian: Jedno je kontrolirano kliničko ispitivanje bilo provedeno s Extavijom u bolesnika s relapsnoremitirajućom multiplom sklerozom koji su mogli hodati bez pomoći (početni EDSS 0 do 5,5). u bolesnika koji su primali Extaviju došlo je do smanjenja u učestalosti (30%) i težini kliničkih relapsa te u broju hospitalizacija zbog bolesti.
English: After reconstitution immediate use recommended.
Croatian: Preporučuje se primijeniti odmah nakon pripreme otopine.
English: AREA 4
Croatian: PODRUČJE 4
English: Dysmenorrhoea Menstrual disorder * Metrorrhagia Impotence
Croatian: Poremećaji menstruacije * 1% (2%) Metroragija
English: 14 vials of interferon beta-1b and 14 pre-filled syringes containing solvent.
Croatian: - 14 bočica interferona beta-1b i 14 napunjenih štrcaljki koje sadrže otapalo.
English: 14 vials of interferon beta-1b and 15 pre-filled syringes containing solvent.
Croatian: 14 bočica interferona beta-1b i 15 napunjenih štrcaljki koje sadrže otapalo.
English: 3-month multipack: 42 (3 packs of 14) vials with powder and 45 (3 packs of 15) pre-filled syringes with 1.2 ml solvent.
Croatian: 3- mjesečno višestruko pakiranje: 42 (3 pakiranja od po 14) bočica s praškom i 45 (3 pakiranja od 15) napunjenih štrcaljki s 1,2 ml otapala.
English: Flu-like symptoms
Croatian: Simptomi nalik gripi
English: Extavia must be used with caution, and your doctor will monitor you for worsening of your heart condition, particularly at the start of treatment.
Croatian: Vaše stanje radi eventualnih znakova pogoršanja stanja srca, osobito na početku liječenja.
English: After reconstitution, 1.0 ml of the solution should be drawn from the vial into the syringe for the administration of 250 microgram Extavia.
Croatian: Za primjenu 250 mikrograma Extavije, potrebno je nakon rekonstitucije iz bočice povući 1,0 ml otopine u štrcaljku.
English: 15 vials of interferon beta-1b and 15 pre-filled syringes containing solvent.
Croatian: - 15 bočica interferona beta-1b i 15 napunjenih štrcaljki koje sadrže otapalo.
English: 15 vials with powder and 15 pre-filled syringes with 1.2 ml solvent.
Croatian: 15 bočica s praškom i 15 napunjenih štrcaljki s 1,2 ml otapala.
English: 14 vials with powder and 15 pre-filled syringes with 1.2 ml solvent.
Croatian: 14 bočica s praškom i 15 napunjenih štrcaljki s 1,2 ml otapala.
English: AREA 6
Croatian: PODRUČJE 6
English: ► Very common (may affect more than 1 in 10 people): - painful joints (arthralgia).
Croatian: Prijavljene nuspojave za lijek na tržištu (učestalosti - ako su poznate - temelje se na kliničkim ispitivanjima): ► Vrlo česte (mogu se javiti u više od 1 na 10 osoba): - bolni zglobovi (artralgija).
English: Chest pain °
Croatian: Desni dio trbuha
English: Urinary protein positive
Croatian: Mokraća pozitivna na proteine (>1+)
English: ► Injection site reactions.
Croatian: Reakcije na mjestu primjene.
English: Confusional state
Croatian: Stanje smetenosti
English: LABEL OF PRE-FILLED SYRINGE
Croatian: Poremećaji probavnog sustava Proljev
English: Abdominal pain °
Croatian: Abnormalan vid
English: Lymphadenopathy
Croatian: Trombocitopenija
English: Chills
Croatian: Apsces
English: Middle right section of each area
Croatian: Desna strana stražnjice
English: This means that it has been used for many years and that there was sufficient information on its effectiveness and safety.
Croatian: To znači da se koristio tijekom mnogo godina te da postoji dovoljno informacija o djelotvornosti i sigurnosti.
English: Because thiotepa has been used for many years in the EU, the company presented data from the published literature.
Croatian: Budući da je tiotepa u uporabi već dugo godina na području EU, tvrtka je dostavila podatke iz objavljene literature.
English: Tepadina thiotepa
Croatian: Tepadina tiotepa
English: It must be given as an infusion into a large vein lasting two to four hours.
Croatian: Lijek treba primjenjivati kao infuziju u veliku venu tijekom razdoblja od dva do četiri sata.
English: Tepadina is used in combination with chemotherapy (medicines to treat cancer) in two ways:
Croatian: Tepadina se koristi u kombinaciji s kemoterapijom (lijekovima za liječenje raka) na dva načina:
English: These substances are ‘cytotoxic'.
Croatian: Ove tvari su „citotoksične“.
English: What measures are being taken to ensure the safe and effective use of Tepadina?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Tepadina?
English: It must also not be used together with the vaccine against yellow fever or vaccines containing live viruses or bacteria.
Croatian: Ne smije se koristiti zajedno sa cjepivom protiv žutice ili cjepivima koji sadrže žive viruse ili bakterije.
English: The dose also depends on the patient's body surface area (calculated using the height and weight of the patient) or on the patient's weight.
Croatian: Doza također ovisi o površini bolesnika (izračunato na temelju visine i tjelesne težine bolesnika) ili o tjelesnoj težini bolesnika.
English: Thiotepa has been used to prepare patients for transplantation of blood-making cells in the European Union (EU) since the late 1980s.
Croatian: Tiotepa je korištena za pripremu bolesnika za transplantaciju krvotvornih stanica na području Europske unije (EU) još od kasnih 1980.-ih.
English: In children, the daily dose ranges from 125 to 350 mg/m2 given for up to three days before transplantation.
Croatian: U djece, rasponi dnevne doze kreću se od 125 do 350 mg/m2 primijenjeno tri dana prije transplantacije.
English: In adults, the daily dose ranges from 120 to 481 mg per square metre (m2) given for up to five days before transplantation.
Croatian: U odraslih osoba, dnevna se doza kreće od 120 do 481 mg po metru kvadratnom (m2) primijenjeno do pet dana prije transplantacije.