FrancophonIA/ELRC3.0 huggingface dataset:
English: The recommended dose of Spectrila for adults is 5,000 U per m² body surface area (BSA) given every third day.
Croatian: Preporučena doza Spectrile za odrasle iznosi 5000 U po m² tjelesne površine, a daje se svaki treći dan.
English: No dose adjustment is necessary in patients with mild to moderate hepatic impairment.
Croatian: Prilagodba doze nije potrebna u bolesnika s blagim do umjerenim oštećenjem funkcije jetre.
English: Expert advice should be sought in cases where AT III is decreased.
Croatian: U slučajevima kada je AT III smanjen, potrebno je zatražiti stručni savjet.
English: It is unknown whether asparaginase is excreted into human breast milk.
Croatian: Nije poznato izlučuje li se asparaginaza u majčino mlijeko.
English: Hyperglycaemia and hypoglycaemia
Croatian: Hiperglikemija i hipoglikemija
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1072/001 (1 vial)
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/15/1072/001 (1 bočica)
English: Haemorrhagic pancreatitis, necrotising pancreatitis, parotitis Very rare
Croatian: Rijetko hemoragijski pankreatitis, nekrotizirajući pankreatitis, parotitis
English: • high blood levels of ammonia (hyperammonaemia)
Croatian: • visoke razine amonijaka u krvi (hiperamonijemija)
English: There is no known case of an overdose with asparaginase where patients showed any signs of an overdose.
Croatian: Nije poznat nijedan slučaj u kojem su bolesnici pokazali znakove predoziranja asparaginazom.
English: Hyperammonaemia
Croatian: Hiperamonemija
English: PHARMACEUTICAL FORM Powder for concentrate for solution for infusion.
Croatian: OBLIK Prašak za koncentrat za otopinu za infuziju.
English: For intravenous use only.
Croatian: SAMO za intravensku primjenu.
English: Hyperglycaemic conditions
Croatian: Hiperglikemijska stanja
English: • jaundice
Croatian: • žutica
English: • feeling sick (nausea), being sick (vomiting), stomach ache or watery stools (diarrhoea)
Croatian: • mučnina, povraćanje, bol u želucu ili vodenasta stolica (proljev)
English: Common Pain (back pain, joint pain)
Croatian: Često bol (bol u leđima, u zglobovima)
English: Duration of administration
Croatian: Trajanje primjene
English: Hypothyroidism
Croatian: Hipotireoza
English: Allergy and anaphylaxis
Croatian: Alergija i anafilaksija
English: • high blood levels of uric acid (hyperuricaemia)
Croatian: • visoke razine uratne kiseline u krvi (hiperuricemija)
English: • destruction of liver cells (liver cell necrosis)
Croatian: • uništenje stanica jetre (nekroza stanica jetre)
English: Mild to moderate changes in blood lipid values (e.g. increased or decreased cholesterol, increased triglyceride, increased VLDL fraction and decreased LDL, increased lipoprotein lipase activity) are very commonly observed in patients treated with asparaginase, which in most cases present without clinical symptoms.
Croatian: povišeni trigliceridi, povišena frakcija VLDL-a i snižen LDL, povišena aktivnost lipoproteinske lipaze) vrlo su često opažene u bolesnika liječenih asparaginazom, što se u većini slučajeva pokazalo bez kliničkih simptoma.
English: CI = confidence interval; CSF = cerebrospinal fluid; MRD = minimal residual disease a
Croatian: CI = interval pouzdanosti; CSF = cerebrospinalna tekućina; MRD = minimalna rezidualna bolest a Bezuvjetno točan interval pouzdanosti prema Chanu i Zhangu b Bezuvjetno točan test neinferiornosti za binomijalne razlike na temelju ograničenog broja procjena maksimalne vjerojatnosti c
English: Acquired or genetically decreased physiologic coagulation inhibitors (protein C, protein S, antithrombin) are also described in relation to vascular complications.
Croatian: Povezano s vaskularnim komplikacijama, opisani su i stečeni ili genetski smanjeni fiziološki inhibitori koagulacije (protein C, protein S, antitrombin).
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Spectrila 10,000 U powder for concentrate for solution for infusion Asparaginase
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Spectrila 10 000 U prašak za koncentrat za otopinu za infuziju asparaginaza
English: Reference asparaginase
Croatian: Način primjene
English: Table 3: Efficacy results (MC-ASP.5/ALL; Full analysis set)
Croatian: Rezultati ovog ispitivanja sažeto su prikazani u tablici 3: Tablica 3: Rezultati djelotvornosti (MC-ASP.5/ALL; svi ispitanici) Terapijska skupina
English: • pain (back pain, joint pain, stomach ache)
Croatian: • bol (bol u leđima, bol u zglobovima, bol u želucu)
English: • low blood sugar level (hypoglycaemia)
Croatian: • niska razina šećera u krvi (hipoglikemija)
English: Since an indirect interaction between components of the oral contraception and asparaginase cannot be ruled out, oral contraceptives are not considered sufficiently safe.
Croatian: Budući da se neizravna interakcija između sastojaka oralne kontracepcije i asparaganaze ne može isključiti, oralna kontracepcija ne smatra se dovoljno pouzdanom.
English: As a result of impaired protein synthesis, the serum protein level (especially albumin) decreases very commonly in patients treated with asparaginase.
Croatian: Kao posljedica narušene sinteze proteina, u bolesnika liječenih asparaginazom vrlo često dolazi do smanjenja razine proteina u serumu (osobito albumina).
English: Diarrhoea, nausea, vomiting, abdominal pain Common
Croatian: Vrlo često proljev, mučnina, povraćanje, bol u abdomenu
English: Study in children/adolescents aged 1 - 18 years with de novo ALL Efficacy and safety of Spectrila was compared to a native E. coli-asparaginase (reference medicinal product) in a randomised double-blinded clinical trial (study MC-ASP.5/ALL; based on ALL treatment protocol DCOG ALL10) in 199 children/adolescents aged 1 - 18 years with de novo ALL.
Croatian: Ispitivanja u djece/adolescenata u dobi od 1 do 18 godina s de novo ALL-om Djelotvornost i sigurnost Spectrile uspoređena je s drugom asparaginazom dobivenom od nativne E. coli (referentni lijek) u randomiziranom dvostruko slijepom kliničkom ispitivanju (ispitivanje
English: Very common Oedema, fatigue
Croatian: Vrlo često edem, umor
English: • Pancreatitis.
Croatian: • pankreatitis
English: Co-administration of other antineoplastic medicinal products contributes to this effect.
Croatian: Tom učinku pridonosi istovremena primjena drugih antineoplastičnih lijekova.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 10,000 units of asparaginase.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedna bočica sadrži 10 000 jedinica asparaginaze.
English: Spectrila 10,000 U powder for concentrate for solution for infusion Asparaginase
Croatian: Spectrila 10 000 U prašak za koncentrat za otopinu za infuziju asparaginaza
English: Not evaluable / not known
Croatian: Nije procjenjivo / nepoznato Razlika (95% CI
English: The following life-threatening situations could arise during treatment with Spectrila:
Croatian: Za vrijeme liječenja Spectrilom, moguće su sljedeće situacije koje ugrožavaju život:
English: Unconditional exact test of non-inferiority for binomial differences based on restricted maximum likelihood estimates c Patients were considered as responders if asparagine values in CSF on protocol day 33 were below the lower limit of quantification.
Croatian: Smatralo se da je bolesnik postigao odgovor ako su vrijednosti asparagina u CFS-u 33. dana protokola bile ispod donje granice kvantifikacije.
English: METHOD OF ADMINISTRATION Read the package leaflet before use.
Croatian: NAČIN PRIMJENE LIJEKA Prije uporabe pročitajte uputu o lijeku.
English: After administration of any asparaginase preparation, close monitoring of bilirubin, hepatic transaminases, blood/urinary glucose, coagulation parameters (e.g. PTT, PT, antithrombin III, fibrinogen and D-dimer), amylase, lipase, triglycerides and cholesterol is recommended.
Croatian: Nakon primjene bilo kojeg pripravka asparaginaze preporučuje se pomno praćenje bilirubina, jetrenih transaminaza, glukoze u krvi/mokraći, parametara koagulacije (npr. PTV, PV, antitrombin III, fibrinogen i D-dimer), amilaze, lipaze, triglicerida i kolesterola.
English: In rare cases, a reversible posterior leukoencephalopathy syndrome (RPLS) has been observed during therapy with asparaginase-containing regimens.
Croatian: U rijetkim slučajevima, tijekom terapije režimima koji sadrže asparaginazu opažen je sindrom reverzibilne posteriorne leukoencefalopatije (RPLS).
English: Plasma ammonia levels should be determined in all patients with unexplained neurologic symptoms or severe and prolonged vomiting.
Croatian: U svih bolesnika s neobjašnjivim neurološkim simptomima ili teškim i produljenim povraćanjem potrebno je odrediti razine amonijaka u plazmi.
English: After administration of asparaginase, close monitoring of bilirubin, hepatic transaminases, of blood/urinary glucose, coagulation parameters (PTT, PT, antithrombin III, fibrinogen, and D-dimer), amylase, lipase, triglycerides, and cholesterol is recommended.
Croatian: Nakon primjene asparaginaze preporučuje se pomno pratiti vrijednosti bilirubina, jetrenih transaminaza, glukoze u krvi/mokraći, parametara koagulacije (PTV, PV, antitrombin III, fibrinogen i D-dimer), amilaze, lipaze, triglicerida i kolesterola.
English: A method other than oral contraceptives should be used in women of childbearing potential.
Croatian: Žene reproduktivne dobi moraju primjenjivati drugačiju metodu kontracepcije od oralnih kontraceptiva.
English: Before initiating therapy bilirubin, hepatic transaminases and coagulation parameters (e.g. partial thromboplastin time [PTT], prothrombin time [PT], antithrombin III and fibrinogen) should be determined.
Croatian: Prije započinjanja terapije potrebno je odrediti vrijednosti bilirubina, jetrenih transaminaza i parametre koagulacije (npr. parcijalno tromboplastinsko vrijeme [PTV], protrombinsko vrijeme [PV], antitrombin III i fibrinogen).
English: The reconstituted solution is stable for 2 days when stored at 2 °C - 8 °C.
Croatian: Pripremljena otopina stabilna je 2 dana na temperaturi 2 °C - 8 °C.
English: What Spectrila looks like and contents of the pack Spectrila is provided as a powder for concentrate for solution for infusion.
Croatian: Spectrila se isporučuje kao prašak za koncentrat za otopinu za infuziju.
English: After reconstitution, one ml contains 2,500 units of asparaginase.
Croatian: Nakon rekonstitucije jedan ml sadrži 2500 jedinica asparaginaze.
English: Renal impairment No dose adjustment is necessary in patients with renal impairment.
Croatian: Prilagodba doze nije potrebna u bolesnika s oštećenjem funkcije bubrega.
English: Sinus vein thrombosis can occur.
Croatian: Može se razviti tromboza venskog sinusa.
English: No anti-asparaginase antibodies were detected in any of the 12 infants < 1 year of age during treatment with Spectrila (study MC-ASP.6/INF).
Croatian: Ni u jednog dojenčeta od njih 12 mlađih od 1 godine nisu opažena protutijela protiv asparaginaze tijekom liječenja Spectrilom (ispitivanje MC-ASP.6/INF).
English: LIST OF EXCIPIENTS Excipient: sucrose.
Croatian: POPIS POMOĆNIH TVARI Pomoćna tvar: saharoza
English: ANNEX IV
Croatian: Dodatku V.
English: After reconstitution 1 ml contains 2,500 units of asparaginase.
Croatian: Nakon pripreme 1 ml sadrži 2500 jedinica asparaginaze.
English: Uncommon Hyperuricaemia, hyperammonaemia
Croatian: Manje često hiperuricemija, hiperamonijemija
English: Hypersensitivity including flushing, rash, hypotension, oedema/angioedema, urticaria, dyspnoea Common
Croatian: Poremećaji imunološkog sustava Vrlo često preosjetljivost uključujući navale vrućine, osip, hipotenziju, edem/angioedem, urtikariju, dispneju
English: Since an indirect interaction between components of the oral contraception and asparaginase cannot be ruled out, oral contraceptives are not considered sufficiently safe in such clinical situation.
Croatian: Budući da se neizravna interakcija između sastojaka oralne kontracepcije i asparaganaze ne može isključiti, oralni kontraceptivi ne smatraju se dovoljno pouzdanima u takvoj kliničkoj situaciji.
English: Unopened vials
Croatian: Neotvorene bočice
English: • high blood sugar level (hyperglycaemia).
Croatian: • visoka razina šećera u krvi (hiperglikemija)
English: Glucocorticoids
Croatian: Glukokortikoidi
English: The ready-to-use solution may exhibit a slight opalescence.
Croatian: Otopina spremna za primjenu može biti blago opalescentna.
English: • acute pancreatitis,
Croatian: • akutni pankreatitis
English: Myelosuppressive agents
Croatian: Mijelosupresivni lijekovi
English: Disseminated intravascular coagulation (DIC), anaemia, leukopenia, thrombocytopenia
Croatian: Poremećaji krvi i limfnog sustava Često diseminirana intravaskularna koagulacija (DIK), anemija, leukopenija, trombocitopenija
English: Effective contraception must be used during treatment and for at least 3 months after asparaginase discontinuation.
Croatian: Tijekom liječenja i barem 3 mjeseca nakon prekida liječenja asparaginazom potrebno je primjenjivati djelotvornu kontracepciju.
English: Traceability
Croatian: Apsorpcija
English: 6.1 List of excipients
Croatian: 6.1 Popis pomoćnih tvari saharoza
English: > 10 times ULN).
Croatian: transaminaze > 10 puta iznad GGN-a)
English: Paediatric population Data on safety of Spectrila in infants < 1 year of age is limited.
Croatian: Ograničeni su podaci o primjeni Spectrile u dojenčadi mlađe od 1 godine.
English: The following life-threatening situations may arise during asparaginase treatment in patients of all age groups:
Croatian: Tijekom liječenja asparaginazom u svim se dobnim skupinama bolesnika mogu pojaviti ove situacije koje ugrožavaju život:
English: No allergic reactions were observed in any of the 12 infants < 1 year of age during treatment with Spectrila (study MC-ASP.6/INF).
Croatian: Tijekom liječenja Spectrilom, od 12 dojenčadi mlađe od 1 godine ni u jednog nisu opažene alergijske reakcije (ispitivanje MC-ASP.6/INF).
English: The active substance is asparaginase.
Croatian: • Djelatna tvar je asparaginaza.
English: EXP: In-use stability has been demonstrated for 2 days at 2 °C - 8 °C.
Croatian: Stabilnost lijeka u primjeni dokazana je za trajanje od 2 dana na temperaturi 2 °C - 8 °C.
English: The daily amount of Spectrila needed per patient can be diluted in a final volume of 50 - 250 ml sodium chloride 9 mg/ml (0.9 %) solution for infusion.
Croatian: Dnevnu količinu Spectrile potrebnu bolesniku može se razrijediti do konačnog volumena u 50 do 250 ml otopine natrijevog klorida 9 mg/ml (0,9%) za infuziju.
English: Dyslipidemia
Croatian: Dislipidemija
English: Anaphylactic shock
Croatian: Rijetko anafilaktički šok
English: NAME OF THE MEDICINAL PRODUCT Spectrila 10,000 U powder for concentrate for solution for infusion Asparaginase
Croatian: NAZIV LIJEKA Spectrila 10 000 U prašak za koncentrat za otopinu za infuziju
English: The calculated quantity of asparaginase is dissolved further in 50 to 250 ml of sodium chloride 9 mg/ml (0.9 %) solution for infusion.
Croatian: Izračunata količina asparaginaze dalje se razrjeđuje u 50 do 250 ml otopine natrijevog klorida 9 mg/ml (0,9%) za infuzije.
English: ANNEX II
Croatian: Tablica 1
English: PHARMACEUTICAL FORM AND CONTENTS Powder for concentrate for solution for infusion 1 vial
Croatian: Prašak za koncentrat za otopinu za infuziju 1 bočica
English: Fax: +49 4103 8006-100
Croatian: Faks: +49 4103 8006-100
English: The calculated quantity of asparaginase is dissolved further in 50 to 250 ml of sodium chloride 9 mg/ml (0.9 %) solution for injection.
Croatian: Izračunata količina asparaginaze dalje se razrjeđuje u 50 do 250 ml otopine natrijevog klorida 9 mg/ml (0,9%) za injekcije.
English: Patients received 5,000 U/m² asparaginase (Spectrila versus a reference E.coli- asparaginase) at days 12, 15, 18, 21, 24, 27, 30, and 33 of induction treatment.
Croatian: Bolesnici su 12., 15., 18., 21., 24., 27., 30. i 33. dana indukcijskog liječenja primili 5000 U/m² asparaginaze (Spectrilu naspram referentne asparaginaze dobivene iz E. coli).
English: Fax: +49-4103-8006-100
Croatian: Faks: +49-4103-8006-100
English: • allergic reactions including serious allergic reaction (anaphylactic shock), flushing, rash, low blood pressure, swelling of face and throat, hives, shortness of breath,
Croatian: osip, nizak krvni tlak, oticanje lica i grla, koprivnjaču, nedostatak zraka,
English: Very rare Secondary hypothyroidism, hypoparathyroidism
Croatian: Vrlo rijetko sekundarna hipotireoza, hipoparatireoidizam Poremećaji metabolizma i prehrane Vrlo često hiperglikemija, hipoalbuminemija
English: Difference (95 % CIa); P valueb
Croatian: a); P vrijednost b
English: The daily amount of asparaginase needed per patient can be diluted in a final volume of 50 - 250 ml sodium chloride 9 mg/ml (0.9 %) solution for injection.
Croatian: Dnevnu količinu asparaginaze potrebnu bolesniku može se razrijediti do konačnog volumena u 50 do 250 ml otopine natrijevog klorida 9 mg/ml (0,9%) za injekciju.
English: • infections
Croatian: • anafilaksija
English: Headaches
Croatian: Doziranje
English: Not known
Croatian: Da Ne
English: Hypoalbuminaemia
Croatian: Hipoalbuminemija
English: • blood clotting disorders such as bleeding, disseminated intravascular coagulation (DIC) or formation of blood clots (thrombosis),
Croatian: • poremećaj zgrušavanja krvi kao što su krvarenje, širenje krvnih ugrušaka krvnom strujom
English: Before initiating therapy bilirubin, hepatic transaminases, and coagulation parameters (partial thromboplastin time [PTT], prothrombin time [PT], antithrombin, fibrinogen, and D-dimer) should be determined.
Croatian: Preporučene kontrolne pretrage i sigurnosne mjere opreza Prije započinjanja terapije, potrebno je odrediti vrijednosti bilirubina, jetrenih transaminaza i parametre koagulacije (parcijalno tromboplastinsko vrijeme [PTV], protrombinsko vrijeme [PV], antitrombin, fibrinogen i D-dimer).
English: • fatty liver
Croatian: • infekcije • masna jetra
English: Liver parameters should be monitored closely before and during treatment with asparaginase.
Croatian: Prije i tijekom liječenj asparaginazom potrebno je pomno pratiti parametre funkcije jetre.
English: A method other than oral contraceptives should be used in women of childbearing potential (see section 4.4).Men should use effective contraceptive measures and be advised to not father a child while receiving asparaginase.
Croatian: Muškarci moraju primjenjivati djelotvorne mjere kontracepcije i treba im savjetovati da ne začinju dijete dok primaju asparaginazu.
English: Tremor
Croatian: Cijepljenje
English: Very common
Croatian: Poluvijek
English: • If you get any side effects, talk to your doctor or nurse.
Croatian: • Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika ili medicinsku sestru.
English: For EpiPen/Nepipe and associated names
Croatian: Za EpiPen/Nepipe i pridružena imena
English: Sometimes a single dose of adrenaline may not be sufficient to completely reverse the effects of a serious allergic reaction.
Croatian: Ponekad jedna doza adrenalina možda neće biti dovoljna kako bi se potpuno poništio učinak ozbiljne alergijske reakcije.
English: If your symptoms have not improved or have deteriorated within 5-15 minutes after the first injection, either you or the person with you should give a second injection.
Croatian: Ako se vaši simptomi ne poboljšaju ili dođe do njihovog pogoršanja unutar 5- 15 minuta nakon prve injekcije, vi ili osoba s vama treba vam dati drugu injekciju.
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: Informacije o lijeku mogu se naknadno ažurirati od strane nadležnih tijela država članica u suradnji s referentnom državom članicom, na odgovarajući način, te u skladu s postupcima opisanim u Poglavlju 4 Dijela III Direktive 2001/83/EC.
English: Section 6 - Contents of the pack and other information
Croatian: Dio 6 - Sadržaj pakiranja i druge informacije
English: All patients who are prescribed [Invented name] should be thoroughly instructed to understand the indications for the use and the correct method of administration (see section 6.6).
Croatian: Sve bolesnike kojima je propisan [zaštićeni naziv] treba detaljno podučiti kako bi razumjeli indikacije za upotrebu i ispravan način primjene (vidjeti dio 6.6).
English: In the absence of clinical improvement or if deterioration occurs, a second injection with an additional [Invented name] may be administered 5-15 minutes after the first injection.
Croatian: U slučaju izostanka kliničkog poboljšanja ili u slučaju pogoršanja stanja, druga dodatna injekcija [zaštićeni naziv] može se dati 5- 15 minuta nakon prve injekcije.
English: It is recommended that your family members, carers or teachers are also instructed in the correct use of [Invented name].
Croatian: Preporučuje se da članovi vaše obitelji, skrbnici ili učitelji također budu obučeni za ispravnu primjenu [zaštićeni naziv].
English: For this reason you should carry more than one [Invented name] with you at all times.
Croatian: Zbog toga trebate u svakom trenutku imati sa sobom više od jednog [zaštićeni naziv].
English: It is strongly advised also to educate the patient's immediate associates (e.g. parents, caregivers, teachers) for the correct usage of the [Invented name] in case support is needed in the emergency situation.
Croatian: Osobito se preporučuje educirati osobe iz bolesnikove neposredne okoline (npr. roditelje, skrbnike, učitelje) za pravilnu upotrebu [zaštićeni naziv] u slučaju da je u hitnoj situaciji potrebna njihova podrška.
English: [The MAH(s) should submit improved diagram in the instructions for use by increasing the size and ensuring that it clearly shows that the injection should be in the antero-lateral aspect of the thigh]
Croatian: [Nositelj(i) odobrenja treba(ju) dostaviti poboljšani dijagram u uputama za upotrebu (povećati veličinu) vodeći računa da je jasno prikazano da je injiciranje potrebno učiniti u anterolateralnu stranu bedra]
English: Section 3 - How to use [Invented name]
Croatian: Dio 3 - Kako primjenjivati [zaštićeni naziv]
English: This Summary of Product Characteristics and package leaflet is the outcome of the referral procedure.
Croatian: Ove izmjene Sažetka opisa svojstava lijeka i upute o lijeku ishod su arbitražnog postupka.
English: Section 3 - How to use [Invented name] [The section should be amended to reflect the following wording]
Croatian: Dio 3 - Kako primjenjivati [zaštićeni naziv] [Ovaj je dio potrebno izmijeniti da uključuje sljedeći tekst]
English: Section 4.4 - Special warnings and precautions for use [The section should be amended to reflect the following wording]
Croatian: Dio 4.4 - Posebna upozorenja i mjere opreza pri uporabi
English: A. Summary of Products Characteristics
Croatian: Sažetak opisa svojstava lijeka
English: Annex III Amendments to relevant sections of the summary of product characteristics and package leaflet
Croatian: Izmjene određenih dijelova sažetka opisa svojstava lijeka i upute o lijeku
English: What [Invented name] looks like and contents of the pack [The section should be amended to reflect the exposed needle length of the device(s)] [To be completed nationally]
Croatian: [Ovaj je dio potrebno izmijeniti da navodi dužinu izložene igle proizvoda] [Dopuniti na nacionalnoj razini]
English: It is recommended that patients are prescribed two [Invented name] pens which they should carry at all times.
Croatian: Preporučuje se da se bolesniku propišu dvije [zaštićeni naziv] brizgalice koje treba imati sa sobom u svakom trenutku.
English: Section 4.2 - Posology and method of administration [The section should be amended to reflect the following wording]
Croatian: Dio 4.2 - Doziranje i način primjene
English: The course of treatment may be repeated but not sooner than 21 days after the start of the first course.
Croatian: Ciklus terapije može se ponoviti, no ne prije nego što prođe 21 dan od početka prvog ciklusa terapije.
English: The recommended dose for adults is 50 to 100 mg per m2 of body surface area for 5 days in a row or 100 to 120 mg/m2 on days 1, 3 and 5.
Croatian: Preporučena doza za odrasle je 50 do 100 mg po m2 površine tijela pet dana za redom ili 100 do 120 mg/m2 prvog, trećeg i petog dana.