FrancophonIA/ELRC3.0 huggingface dataset:
English: Therefore, men treated with Busilvex are advised not to father a child during and up to 6 months after treatment and to seek advice on cryo-conservation of sperm prior to treatment because of the possibility of irreversible infertility due to therapy with Busilvex.
Croatian: Stoga se muškarcima liječenim Busilvexom preporuča da tijekom liječenja i do 6 mjeseci nakon liječenja ne začinju dijete i da zatraže savjet o kriokonzervaciji sperme prije liječenja zbog mogućnosti ireverzibilne neplodnosti uslijed liječenja Busilvexom.
English: Serious toxicities involving the hepatic and respiratory systems were considered as expected consequences of the conditioning regimen and transplant process.
Croatian: Ozbiljne toksičnosti koje su obuhvaćale hepatički i respiratorni sustav smatrale su se očekivanim posljedicama protokola kondicioniranja i postupka presađivanja.
English: Only a clear solution without any particles should be used.
Croatian: Smije se primjenjivati samo bistra otopina bez ikakvih čestica.
English: Men treated with Busilvex are advised not to father child during and up to 6 months after treatment.
Croatian: Muškarcima liječenima Busilvexom ne preporučuje se da začinju dijete tijekom i do 6 mjeseci nakon liječenja.
English: Only a clear solution without particles should be used.
Croatian: Smije se primjenjivati samo bistra otopina bez čestica.
English: Since, busulfan is metabolized through conjugation with glutathione, administration of glutathione might be considered.
Croatian: Budući da se busulfan metabolizira konjugacijom s glutationom, može se razmotriti primjena glutationa.
English: Busilvex is administered as a two-hour infusion every 6 hours over 4 consecutive days for a total of 16 doses prior to cyclophosphamide or melphalan and haematopoietic progenitor cell transplantation (HPCT).
Croatian: Busilvex se primjenjuje kao dvosatna infuzija svakih 6 sati tijekom 4 uzastopna dana odnosno ukupno 16 doza prije ciklofosfamida ili melfalana i presađivanja hematopoetskih progenitorskih stanica (HPCT).
English: Special caution should be exercised when administering the recommended dose of Busilvex to patients with a history of seizures.
Croatian: Posebna pozornost potrebna je kada se preporučena doza Busilvexa daje bolesnicima s anamnezom napadaja.
English: Busilvex will be administered every 6 hours during 4 consecutive days prior to transplant.
Croatian: - Busilvex će se primjenjivati svakih 6 sati tijekom 4 uzastopna dana prije presađivanja.
English: ANNEX II A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Croatian: PRILOG II. A. PROIZVOĐAČ(I) ODGOVORAN(NI) ZA PUŠTANJE SERIJE LIJEKA U PROMET B. UVJETI ILI OGRANIČENJA VEZANI UZ OPSKRBU I PRIMJENU
English: Other frequent anomalies included cleft palate, anasarca and skeletal anomalies of the vertebrae and ribs.
Croatian: Ostale česte anomalije obuhvaćale su rascjep nepca, anasarku i koštane anomalije kralježnice i rebara.
English: The time to Absolute Neutrophil Count (ANC) greater than 0.5x109 /l was 13 days (range 9-29 days) in allogenic patients (OMC-BUS 4), and 10 days
Croatian: Vrijeme do apsolutnog broja neutrofila (ABN) većeg od 0,5x109 /l bilo je 13 dana (raspon od 9-29 dana) u alogenih bolesnika (OMC-BUS 4) i 10 dana
English: What Busilvex looks like and contents of the pack Busilvex consists of a concentrate for solution for infusion and is supplied in colourless glass vials, each vial containing 60 mg of busulfan.
Croatian: Busilvex se sastoji od koncentrata za otopinu za infuziju i isporučuje se u bezbojnim staklenim bočicama, svaka bočica sadrži 60 mg busulfana.
English: Various chromosome aberrations have been observed in cells from patients receiving oral busulfan.
Croatian: Razne aberacije kromosoma primijećene su u stanicama bolesnika koji primaju peroralni busulfan.
English: PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for infusion Multipack: 8 (2 packs of 4) vials of 10 ml 60 mg per vial
Croatian: Koncentrat za otopinu za infuziju Višestruko pakiranje: 8 (2 pakiranja od 4) bočice od 10 ml 60 mg po bočici
English: Busilvex dose (mg/kg)
Croatian: Doza Busilvexa (mg/kg)
English: Documentation of the safety and efficacy of Busilvex in combination with cyclophosphamide in the BuCy4 or with melphalan in the BuMel regimen prior to conventional allogeneic and/or autologous HPCT derives from clinical trial F60002 IN 101 G0.
Croatian: Dokumentacija o sigurnosti i djelotvornosti Busilvexa u kombinaciji s ciklofosfamidom u protokolu BuCy4 ili s melfalanom u protokolu BuMel prije konvencionalnog alogenog i/ili autolognog HPCT-a potječe iz kliničkog ispitivanja F60002 IN 101 G0.
English: Terminal volume of distribution Vz ranged between 0.62 and 0.85 l/kg.
Croatian: Vz bio je u rasponu između 0,62 i 0,85 l/kg.
English: The concomitant systemic administration of phenytoin to patients receiving high-dose of oral busulfan has been reported to increase busulfan clearance, due to induction of glutathion-S-transferase whereas no interaction has been reported when benzodiazepines such as diazepam, clonazepam or lorazepam have been used to prevent seizures with high-dose busulfan.
Croatian: Prijavljeno je da istodobna sistemska primjena fenitoina kod bolesnika koji primaju visoke peroralne doze busulfana povećava klirens busulfana zbog indukcije glutation-S-transferaze, dok za primjenu benzodiazepina kao što su diazepam, klonazepam ili lorazepam koji se primjenjuju za sprječavanje napadaja uz visoke doze busulfana nije prijavljena interakcija.
English: Studies in renally impaired patients have not been conducted, however, as busulfan is moderately excreted in the urine, dose modification is not recommended in these patients.
Croatian: Ispitivanja na bolesnicima s oštećenjem funkcije bubrega nisu provedena, no kako se busulfan umjereno izlučuje u urin, u tih se bolesnika ne preporučuje prilagodba doze.
English: Rhinitis Pharyngitis
Croatian: Rinitis Faringitis
English: Myelo-suppression and immuno-suppression were the desired therapeutic effects of the conditioning regimen.
Croatian: Mijelosupresija i imunosupresija bile su željeni terapijski učinak protokola kondicioniranja.
English: The entire prescribed Busilvex dose should be delivered over two or three hours depending on the conditioning regimen.
Croatian: Ukupna propisana doza Busilvexa mora se primijeniti tijekom dva ili tri sata, ovisno o protokolu kondicioniranja.
English: One ml of concentrate contains 6 mg of busulfan (60 mg in 10 ml).
Croatian: Jedan ml koncentrata sadrži 6 mg busulfana (60 mg u 10 ml).
English: Adverse reactions reported both in adults and paediatric patients as more than an isolated case are listed below, by system organ class and by frequency.
Croatian: Nuspojave prijavljene u odraslih i pedijatrijskih bolesnika veće brojnosti nego samo u izoliranim slučajevima navedene su u nastavku, prema klasifikaciji organskih sustava i po učestalosti.
English: Severe granulocytopenia, thrombocytopenia, anaemia, or any combination thereof may develop.
Croatian: Moguć je razvoj teške granulocitopenije, trombocitopenije, anemije ili bilo koje kombinacije navedenih stanja.
English: Busilvex in combination with fludarabine (FB)
Croatian: Busilvex u kombinaciji s fludarabinom (FB)
English: Anaemia (haemoglobin< 8.0 g/dl) occurred in 100% of patients.
Croatian: Anemija (hemoglobin < 8,0 g/dl) se pojavila u 100% bolesnika.
English: From published studies in adults, administration of itraconazole to patients receiving high-dose busulfan may result in reduced busulfan clearance.
Croatian: . U objavljenim ispitivanjima na odraslima pokazalo se da primjena itrakonazola na bolesnicima koji primaju visoke doze busulfana može rezultirati smanjenim klirensom busulfana.
English: - Busilvex will be administered at 3.2 mg/kg as a single daily three-hour infusion immediately after fludarabine for 2 or 3 consecutive days.
Croatian: - Busilvex se primjenjuje u dozi od 3,2 mg/kg kao trosatna infuzija jednom dnevno odmah nakon fludarabina u 2 ili 3 uzastopna dana.
English: Interaction between busulfan and metronidazol has been reported in literature reviews and post marketing cases.
Croatian: Interakcija između busulfana i metronidazola navedena je u preglednim člancima i kod slučajeva nakon stavljanja lijeka u promet.
English: Intravenous use (IV) Must be diluted before use Read the package leaflet before use
Croatian: Primjena u venu (i.v.) Prije uporabe mora se razrijediti Prije uporabe pročitajte uputu o lijeku
English: All children engrafted.
Croatian: Kod sve je djece provedeno presađivanje.
English: The recommended dose of Busilvex is 3.2 mg/kg Each infusion will last 3 hours
Croatian: - Preporučena doza Busilvexa je 3,2 mg/kg - Svaka infuzija trajat će 3 sata.
English: Busulfan can impair fertility.
Croatian: Busulfan može smanjiti plodnost.
English: ** reported in post marketing with IV busulfan *** reported in post marketing with oral busulfan
Croatian: ** prijavljeno nakon stavljanja lijeka u promet s intravenskim (i.v.) busulfanom *** prijavljeno nakon stavljanja lijeka u promet s peroralnim busulfanom
English: Frequent complete blood counts, including differential white blood cell counts, and platelet counts should be monitored during the treatment and until recovery is achieved.
Croatian: Tijekom liječenja i do postizanja oporavka moraju se često kontrolirati kompletna krvna slika, uključujući diferencijalnu sliku bijelih krvnih zrnaca i broj trombocita.
English: Within each frequency grouping, adverse events are presented in order of decreasing seriousness.
Croatian: Unutar svake skupine učestalosti nuspojave su navedene od težih do manje teških.
English: In adults, for the FB regimen, published studies did not report any mutual drug-drug interaction between intravenous busulfan and fludarabine.
Croatian: Za protokol FB-a, u objavljenim ispitivanjima u odraslih nisu zabilježene nikakve međusobne interakcije između intravenskog busulfana i fludarabina.
English: In adults, absolute neutrophil counts < 0.5x109/l at a median of 4 days post transplant occurred in 100% of patients and recovered at median day 10 and 13 days following autologous and allogeneic transplant respectively (median neutropenic period of 6 and 9 days respectively).
Croatian: U odraslih se apsolutan broj neutrofila < 0,5x109/l pri medijanu od 4 dana nakon presađivanja pojavio u 100% bolesnika i oporavio u medijanu od 10 dana nakon autolognog i 13 dana nakon alogenog presađivanja (medijan neutropenijskog razdoblja od 6, odnosno 9 dana).
English: Skin: rash, itching, loss of hairs.
Croatian: Koža: osip, svrbež, gubitak kose.
English: Chemical and physical in-use stability after dilution in glucose 5% or sodium chloride 9 mg/ml (0.9%) solution for injection has been demonstrated for 8 hours (including infusion time) after dilution when stored at 20 °C  5 °C or 12 hours after dilution when stored at 2 °C-8 °C followed by 3 hours stored at 20 °C  5 °C (including infusion time).
Croatian: Kemijska i fizička stabilnost u primjeni nakon razrjeđivanja u 5%-tnoj otopini glukoze ili otopini natrijeva klorida 9 mg/ml (0,9%) za injekciju dokazana je za 8 sati (uključujući vrijeme infuzije) nakon razrjeđivanja ako se čuva na temperaturi od 20 °C  5 °C ili 12 sati nakon razrjeđivanja ako se čuva na temperaturi od 2 °C - 8 °C nakon čega je uslijedilo 3 sata ako se čuva na temperaturi od 20 °C  5 °C (uključujući vrijeme infuzije).
English: The entire prescribed Busilvex dose should be delivered over two or three hours depending of the conditioning regimen.
Croatian: Ukupna propisana doza Busilvexa mora se primijeniti tijekom dva ili tri sata ovisno o protokolu kondicioniranja.
English: Busilvex must always be added to the diluent, not the diluent to Busilvex.
Croatian: Busilvex se uvijek mora dodati otapalu, a ne otapalo u Busilvex.
English: Busilvex in combination with fludarabine
Croatian: Busilvex u kombinaciji s fludarabinom
English: In paediatric population, absolute neutrophil counts < 0.5x109/l at a median of 3 days post transplant occurred in 100% of patients and lasted 5 and 18.5 days in autologous and allogeneic transplant respectively.
Croatian: U pedijatrijskoj populaciji apsolutan broj neutrofila < 0,5x109/l pri medijanu od 3 dana nakon presađivanja pojavio se u 100% bolesnika te se zadržao 5 dana nakon autolognog i 18,5 dana nakon alogenog presađivanja.
English: Busulfan treatment in a pre-adolescent girl prevented the onset of puberty due to ovarian failure.
Croatian: Liječenje busulfanom djevojčica u preadolescenciji spriječilo je nastupanje puberteta zbog zatajenja jajnika.
English: The safety profile of Busilvex combined with fludarabine (FB) has been examined through a review of adverse events reported in published data from clinical trials in RIC regimen.
Croatian: Sigurnosni profil lijeka Busilvex u kombinaciji s fludarabinom (FB) ispitan je putem pregleda nuspojava zabilježenih u objavljenim podacima iz kliničkih ispitivanja protokola kondicioniranja smanjenog intenziteta.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Busilvex 6 mg/ml sterile concentrate
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Busilvex 6 mg/ml sterilni koncentrat i.v.
English: A reduced incidence of Hepatic Veno Occlusive Disease (HVOD) and other regimenrelated toxicity have been observed in patients when the lag time between the last dose of oral busulfan and the first dose of cyclophosphamide is > 24hours.
Croatian: HVOD) i toksičnosti povezane s ostalim protokolima zabilježena je u bolesnika kada je vrijeme latencije između posljednje peroralne doze busulfana i prve doze ciklofosfamida > 24 sata.
English: In new-born infants, children and adolescents, Busilvex is used in combination with cyclophosphamide or melphalan.
Croatian: Kod novorođenčadi, djece i adolescenata Busilvex se primjenjuje u kombinaciji s ciklofosfamidom ili melfalanom.
English: Diluted Busilvex is a clear colourless solution.
Croatian: Razrijeđeni Busilvex je bistra, bezbojna otopina.
English: Renal: increase in creatinine elimination, discomfort in urination, decrease in urine output and bloody urine.
Croatian: Bubrezi: povećanje uklanjanja kreatinina, nelagoda pri mokrenju, smanjeno izlučivanje urina i krvavi urin.
English: Busilvex must be prepared by a healthcare professional using sterile transfer techniques.
Croatian: Busilvex mora pripremiti zdravstveni radnik koristeći se sterilnim tehnikama prijenosa.
English: Patients received a conditioning regimen based on the administration of fludarabine immediately followed by single daily dose of 3.2 mg/kg busulfan over 2 or 3 consecutive days.
Croatian: Bolesnici su primili protokol kondicioniranja koji se temelji na primjeni fludarabina nakon kojeg je odmah uslijedila doza od 3,2 mg/kg busulfana jednom dnevno 2 ili 3 uzastopna dana.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Pierre Fabre Médicament
Croatian: NOSITELJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Pierre Fabre Médicament
English: Cardiac: changes and abnormalities in heart rhythm, fluid retention or inflammation around the heart, decrease heart output.
Croatian: Srce: promjene i abnormalnosti srčanog ritma, zadržavanje tekućine ili upala oko srca, smanjeni izlazni volumen srca.
English: Busilvex followed by cyclophosphamide (BuCy4) or melphalan (BuMel) is indicated as conditioning treatment prior to conventional haematopoietic progenitor cell transplantation in paediatric patients.
Croatian: Busilvex nakon kojeg slijedi ciklofosfamid (BuCy4) ili melfalan (BuMel) indiciran je kao terapija kondicioniranja prije konvencionalnog presađivanja hematopoetskih progenitorskih stanica u pedijatrijskih bolesnika.
English: Vomiting Dyspepsia Ascites
Croatian: Povraćanje Dispepsija Ascites
English: Nervous system: delirium, nervousness, hallucination, agitation, abnormal brain function, cerebral haemorrhage, and seizure.
Croatian: Živčani sustav: delirij, nervoza, halucinacije, nemir, nenormalno funkcioniranje mozga, krvarenje u mozgu i napadaji.
English: Adverse events information are derived from the clinical study in paediatrics (n=55).
Croatian: Informacije o nuspojavama dobivene su iz kliničkog ispitivanja pedijatrijske populacije (n=55).
English: The median duration of neutropenia was 6 days and 9 days for autologous and allogeneic patients.
Croatian: Medijan trajanja neutropenije bio je 6 dana za autologne i 9 dana za alogene bolesnike.
English: There are no or limited amount of data from the use of busulfan or DMA in pregnant women.
Croatian: Podataka o primjeni busulfana ili DMA u trudnica nema ili su ograničeni.
English: Interstitial lung disease**
Croatian: Intersticijska bolest pluća **
English: Bilirubin increased GGT increased Alkaline phosphatases increased
Croatian: Povišeni bilirubin Povišeni GGT Povišena alkalna fosfataza
English: Busilvex is supplied as a clear colourless solution in 10 ml clear glass vials (type I).
Croatian: Busilvex se na tržištu nalazi kao bistra, bezbojna otopina u staklenim, prozirnim bočicama od 10 ml (staklo tip I).
English: Adverse reactions reported as more than an isolated case are listed below, by system organ class and by frequency.
Croatian: Nuspojave prijavljene kao više od jednog izoliranog slučaja navedene su u nastavku prema klasifikaciji organskih sustava i učestalosti.
English: Busilvex followed by cyclophosphamide (BuCy2) is indicated as conditioning treatment prior to conventional haematopoietic progenitor cell transplantation (HPCT) in adult patients when the combination is considered the best available option.
Croatian: Busilvex nakon kojeg slijedi ciklofosfamid (BuCy2) indiciran je kao terapija kondicioniranja prije konvencionalnog presađivanja hematopoetskih progenitorskih stanica u odraslih bolesnika kada se ta kombinacija smatra najboljom raspoloživom mogućnošću.
English: Pierre Fabre Médicament 45, Place Abel Gance F-92654 Boulogne Billancourt Cedex France
Croatian: Pierre Fabre Médicament 45, place Abel Gance F-92654 Boulogne Billancourt cedex Francuska
English: Busilvex as well as busulfan has not been studied in patients with hepatic impairment.
Croatian: Ni Busilvex ni busulfan nisu ispitivani na bolesnicima s oštećenjem funkcije jetre.
English: Haematemesis Ileus
Croatian: Hematemeza Ileus
English: Increase of lactate dehydrogenase in the blood.
Croatian: Povišenje laktat dehidrogenaze u krvi.
English: Any unused medicinal product or waste material should be disposed of in accordance with local requirements
Croatian: Neiskorišteni lijek ili otpadni materijal potrebno je zbrinuti sukladno nacionalnim propisima
English: was 11.3% (95%CI, 5.5-19.3%), and that of relapse or progression from allo-HCT was 43.8% (95CI,
Croatian: Nakon 2 godine, ukupna incidencija smrtnosti koja nije povezana s relapsom iznosila je 11,3% (95%-tni CI, 5,5 - 19,3%), a ona od relapsa ili progresije od alogenog HCT-a iznosila 43,8% (95%-tni CI, 31,155,7%).
English: Hyperglycaemia Hypocalcaemia Hypokalaemia Hypomagnesaemia Hypophosphatemia
Croatian: Anoreksija Hiperglikemija Hipokalcijemija Hipokalijemija Hipomagnezijemij a
English: The MAH of Busilvex has responded to the question of “Thrombotic microangiopathy” (TMA) after hematopoietic cell transplantation (HCT) requested as supplementary information.
Croatian: Nositelj odobrenja za stavljanje lijeka u promet za lijek Busilvex dao je odgovor na pitanje „trombotičke mikroangiopatije“ (TMA, engl. thrombotic microangiopathy) nakon transplantacije hematopoetskih matičnih stanica (HCT, engl. hematopoietic cell transplantation) koje je postavljeno radi dobivanja dodatnih informacija.
English: Busilvex administration should be supervised by a physician experienced in conditioning treatment prior to haematopoietic progenitor cell transplantation.
Croatian: Primjenu lijeka Busilvex mora nadzirati liječnik iskusan u terapiji kondicioniranja koje prethodi presađivanju hematopoetskih progenitorskih stanica.
English: In adults and children studies, data with Busilvex were obtained when using concomitant administration of either phenytoin or benzodiazepines for seizure prophylaxis.
Croatian: U ispitivanjima na odraslima i djeci podaci za Busilvex dobiveni su kada se za profilaksu napadaja istodobno primjenjivao ili fenitoin ili benzodiazepini.
English: Busulfan is a potent cytotoxic agent and a bifunctional alkylating agent.
Croatian: Busulfan je učinkovito citotoksično sredstvo i bifunkcionalno alkalizirajuće sredstvo.
English: Busilvex must be diluted prior to administration.
Croatian: Busilvex se prije primjene mora razrijediti.
English: In adults Busilvex is used in combination with cyclophosphamide or fludarabine.
Croatian: U odraslih se Busilvex primjenjuje u kombinaciji s ciklofosfamidom ili fludarabinom.
English: Agitation Confusional state Hallucination
Croatian: Agitacija Stanje smetenosti Halucinacija
English: Prophylactic or empiric use of anti-infectives (bacterial, fungal, viral) should be considered for the prevention and management of infections during the neutropenic period.
Croatian: Za sprječavanje i liječenje infekcija tijekom neutropeničnog razdoblja mora se razmotriti preventivna ili empirijska upotreba lijekova protiv infekcija (bakterijskih, gljivičnih, virusnih).
English: The incidence of acute graft versus host disease (a-GVHD) data was collected in OMC-BUS-4 study (allogeneic)(n=61).
Croatian: Graft-versus host disease) prikupljeni su u ispitivanju OMC-BUS-4 (alogeno) (n=61).
English: Any unused medicinal product or waste material should be disposed of in accordance with local requirements for cytotoxic medicinal products.
Croatian: Neiskorišteni lijek ili otpadni materijal potrebno je zbrinuti sukladno nacionalnim propisima za citotoksične lijekove.
English: Vascular disorders Hypertension Hypotension
Croatian: Hipertenzija Hipotenzija Tromboza Vazodilatacija
English: Impotence, sterility, azoospermia, and testicular atrophy have been reported in male patients.
Croatian: U muških bolesnika prijavljena je impotencija, sterilnost, azoospermija i testikularna atrofija.
English: Patients received doses of 0.8 mg/kg busulfan every 6 hours infusion for a total 16 doses followed by cyclophosphamide at 60 mg/kg once per day for two days (BuCy2 regimen).
Croatian: Bolesnici su primali busulfan u dozama od 0,8 mg/kg svakih 6 sati u infuziji u ukupno 16 doza nakon čega je uslijedio ciklofosfamid 60 mg/kg jednom na dan tijekom dva dana (protokol BuCy2).
English: - the contents of the syringe must be dispensed into an intravenous bag (or syringe) which already contains the calculated amount of the selected diluent.
Croatian: izračunati volumen Busilvexa mora se ukloniti iz bočice. sadržaj štrcaljke mora se ubrizgati u intravensku vrećicu (ili štrcaljku) koja već sadrži izračunatu količinu odabranog otapala.
English: There is no known antidote to Busilvex other than haematopoietic progenitor cell transplantation.
Croatian: Ne postoji poznati protulijek za Busilvex osim presađivanja hematopoetskih progenitorskih stanica.
English: One ml of concentrate contains 6 mg busulfan (60 mg in the vial).
Croatian: Jedan ml koncentrata sadrži 6 mg busulfana (60 mg u bočici).
English: Weight increased Abnormal breath sounds
Croatian: Abnormalni zvukovi disanja Povišeni kreatinin
English: • Quantity of diluent: (A ml Busilvex) x (10) = B ml of diluent To prepare the final solution for infusion, add (A) ml of Busilvex to (B) ml of diluent (sodium chloride 9 mg/ml (0.9%) solution for injection or glucose solution for injection 5%) Preparation of the solution for infusion
Croatian: • Količina otapala: (A ml Busilvex) x (10) = B ml otapala Za pripremu konačne otopine za infuziju, dodajte (A) ml Busilvexa u (B) ml otapala (otopina natrijeva klorida 9 mg/ml (0,9%) za injekciju ili 5%-tna otopina glukoze za injekciju) Priprema otopine za infuziju
English: Y: body weight of the patient in kg D: dose of Busilvex (see section 4.2)
Croatian: 6 (mg/ml) Y: tjelesna težina bolesnika u kg D: doza Busilvexa (vidjeti dio 4.2)