natgillin/translations-raw huggingface dataset:
Relapse: In all conditioning treatments containing thiotepa, relapse rates at more than 1 year have been reported as being 60% or lower, which was considered by the physicians as the threshold to prove efficacy.
Recidiv: U svim pripremnim liječenjima s tiotepom, zabilježene su stope recidiva koje su nakon više od godinu dana iznosile 60% ili manje, što po mišljenju liječnika predstavlja prag koji pokazuje djelotvornost.
Idiopathic pneumonia syndrome Pulmunary haemorrage Pulmonary oedema
Sindrom idiopatske pneumonije Plućno krvarenje
The reconstituted solution is hypotonic and must be further diluted prior to administration with 500 ml sodium chloride 9 mg/ml (0.9%) solution for injection (1000 ml if the dose is higher than 500 mg) or with an appropriate volume of sodium chloride 9 mg/ml (0.9%) in order to obtain a final TEPADINA concentration between 0.5 and 1 mg/ml.
Rekonstituirana otopina je hipotonična i mora se prije primjene dalje razrijediti u 500 ml otopine natrijevog klorida 9 mg/ml (0,9%) za injekcije (1000 ml ako je doza veća od 500 mg) ili u prikladnom volumenu natrijevog klorida 9 mg/ml (0,9%) kako bi se dobila konačna koncentracija lijeka TEPADINA između 0,5 i 1 mg/ml.
Multi-organ failure Pain
Višestruko otkazivanje organa Bol
Overall Survival: OS ranged from 30% to 87% with a follow-up ranging from 11.7 up to 87 months.
Sveukupno preživljenje (OS - Overall Survival): OS je bio u rasponu od 30% do 87% uz period praćenja u rasponu od 11,7 do 87 mjeseci.
After reconstitution, each ml contains 10 mg thiotepa (10 mg/ml).
Nakon pripreme za primjenu, svaki ml sadrži 10 mg tiotepe (10 mg/ml).
BREAST CANCER
RAK DOJKE
Venoocclusive liver disease
Veno-okluzivna bolest jetre
It is likely that certain adverse events of thiotepa like dizziness, headache and blurred vision could affect your ability to drive and use machines.
Vjerojatno je da neke nuspojave tiotepe kao što su onaglica, glavobolja i zamagljen vid mogu utjecati na Vašu sposobnost upravljanja vozilima i rada sa strojevima.
You must tell your doctor if you are pregnant or you think you may be pregnant before you receive TEPADINA.
Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku za savjet prije nego uzmete ovaj lijek.
TEPADINA is a white crystalline powder supplied in a glass vial containing 15 mg thiotepa.
Kako TEPADINA izgleda i sadržaj pakiranja TEPADINA je bijeli kristalinični prašak u staklenoj bočici koja sadrži 15 mg tiotepe.
- The active substance is thiotepa.
Što TEPADINA sadrži - Djelatna tvar je tiotepa.
The total volume of reconstituted vials to be administered should be further diluted in 500 ml of sodium chloride 9 mg/ml (0.9%) solution for injection prior to administration (1000 ml if the dose is higher than 500 mg).
Ukupni volumen rekonstituiranih bočica koje će se upotrijebiti treba dalje razrijediti u 500 ml otopine za injekcije natrijevog klorida 9 mg/ml (0,9%) prije primjene (1000 ml ako je doza veća od 500 mg).
LEUKAEMIA
LEUKEMIJA
Relapse: In all conditioning treatments containing thiotepa, relapse rates at more than 1 year have been reported as being lower than 60%, which was considered by the physicians as the threshold to prove efficacy.
Recidiv: U svim pripremnim liječenjima s tiotepom, zabilježene su stope recidiva koje su nakon više od godinu dana iznosile manje od 60%, što po mišljenju liječnika predstavlja prag koji pokazuje djelotvornost.
Overall Survival: OS ranged from 31% to 81% with a follow-up ranging from 7.3 up to 120 months.
Sveukupno preživljenje (OS - Overall Survival): OS je bio u rasponu od 31% do 81% uz period praćenja u rasponu od 7,3 do 120 mjeseci.
Back pain Myalgia Arthralgia
Bol u leđima Mialgija Artralgija
TEPADINA is a white crystalline powder supplied in a glass vial containing 100 mg thiotepa.
Kako TEPADINA izgleda i sadržaj pakiranja TEPADINA je bijeli kristalinični prašak u staklenoj bočici koja sadrži 100 mg tiotepe.
It is likely that certain adverse reactions of thiotepa like dizziness, headache and blurred vision could affect your ability to drive and use machines.
Vjerojatno je da neke nuspojave tiotepe kao što su omaglica, glavobolja i zamagljen vid mogu utjecati na Vašu sposobnost upravljanja vozilima i rada sa strojevima.
Daily white blood cell counts and platelet counts are recommended during therapy with thiotepa and after transplant for at least 30 days.
Tijekom terapije sa tiotepom kao i do najmanje 30 dana poslije transplantacije se preporučuje svakodnevno određivanje broja leukocita i trombocita.
Because TEPADINA destroys bone marrow cells responsible for producing blood cells, regular blood tests will be taken during treatment to check your blood cell counts.
Tijekom liječenja, morat ćete vršiti redovite krvne pretrage kako biste provjerili broj krvnih stanica jer TEPADINA uništava stanice koštane srži odgovorne za proizvodnju krvnih stanica.
CNS TUMOURS
TUMORI CNS-a
Hypogonadism
Hipogonadizam
Disease Free Survival (DFS): An estimated 43% at five years has been reported, confirming that conditioning treatments containing thiotepa following autologous HPCT are effective therapeutic strategies for treating patients with haematological diseases.
Preživljenje bez bolesti (DFS - Disease Free Survival): Procijenjeni postotak preživljenja bez bolesti nakon pet godina je bio 43%, što potvrđuje da su pripremne terapije s tiotepom, nakon kojih slijede autologne TKMS, učinkovite terapijske strategije u liječenju bolesnika s hematološkim bolestima.
Male patients should seek for sperm preservation before therapy is started and should not father a child while treated and during the year after cessation of treatment.
Bolesnicima muškog spola se preporučuje zamrzavanje sperme prije početka terapije te se preporučuje da ne začinju dijete tijekom liječenja te u godini koja slijedi nakon prekida liječenja.
The volume of distribution of thiotepa is large and it has been reported as ranging from 40.8 l/m2 to 75 l/m2, indicating distribution to total body water.
Nakon intravenske primjene, plazmatske koncentracije djelatne tvari slijede model s dva odjeljka s brzom fazom distribucije.Volumen distribucije tiotepe je velik, te je prema dostupnim podacima u rasponu od 40,8 l/m do 75 l/m2, što upućuje na raspodjelu u ukupnoj tjelesnoj vodi.
Studies in renally impaired patients have not been conducted.
Nisu provedene studije kod bolesnika s oštećenjem funkcije bubrega.
Disease Free Survival (DFS): Percentages reported with follow-up periods of more than 1 year confirm that conditioning treatments containing thiotepa following autologous HPCT are effective choices for treating patients with solid tumours.
Preživljenje bez bolesti (DFS - Disease Free Survival): Navedeni postoci, uz razdoblja praćenja dulja od jedne godine, potvrdili su da je pripremno liječenje s tiotepom nakon kojeg slijedi autologna TKMS učinkovit izbor za liječenje bolesnika sa solidnim tumorima.
Accord Healthcare Polska Sp. z o.o.
Accord Healthcare B.V.
Solid tumours
Solidni tumori
Platelet and red blood cell support, as well as the use of growth factors such as Granulocytecolony stimulating factor (G-CSF), should be employed as medically indicated.
U slučaju kliničke indikacije potrebne su transfuzije eritrocita i trombocita kao i primjena čimbenika rasta kao što je faktor stimulacije kolonije granulocita (G-CSF).
Linearity /non linearity There is no clear evidence of saturation of metabolic clearance mechanisms at high doses of thiotepa.
Nema jasnog dokaza zasićenja mehanizama metaboličkog klirensa pri visokim dozama tiotepe.
Name and address of the manufacturer(s) responsible for batch release
Naziv(i) i adresa(e) proizvođača odgovornog(ih) za puštanje serije lijeka u promet RIEMSER Pharma GmbH
Haemorrhage Embolism
Hemoragijski cistitis
CSF and plasma concentrations of TEPA, the first reported active metabolite of thiotepa, exceed the concentrations of the parent compound.
Koncentracije TEPA, glavnog aktivnog metabolita tiotepe, u likvoru i plazmi prelaze koncentracije same tiotepe.
Leukopenia Thrombocytopenia Febrile neutropenia Anaemia
Febrilna neutropenija Anemija
Liver failure
Zatajenje jetre
Disease Free Survival (DFS): Percentages reported with follow-up periods of more than 1 year and up to 5 years confirm that conditioning treatments containing thiotepa following allogeneic HPCT are effective choices for treating patients with haematological diseases.
Preživljenje bez bolesti (DFS - Disease Free Survival) Navedeni postoci uz razdoblja praćenja dulja od jedne godine do 5 godina su potvrdili da je pripremna terapija s tiotepom nakon koje slijedi alogena TKMS učinkovit izbor za liječenje bolesnika sa hematološkim bolestima.
Frequency of administration
Višestruko otkazivanje organa
If thiotepa accidentally contacts mucous membranes, they must be flushed thoroughly with water.
Ako tiotepa slučajno dođe u dodir sa sluznicama, one se moraju temeljito isprati sa vodom.
One vial of powder contains 100 mg thiotepa.
Jedna bočica praška sadrži 100 mg tiotepe.
How to use TEPADINA
Kako primjenjivati lijek TEPADINA
One vial of powder contains 15 mg thiotepa.
Jedna bočica praška sadrži 15 mg tiotepe.
Using a syringe fitted with a needle, aseptically withdraw 10 ml of sterile water for injections.
Koristeći štrcaljku s pričvršćenom iglom, aseptički izvucite 10 ml vode za injekcije.
Using a syringe fitted with a needle, aseptically withdraw 1.5 ml of sterile water for injection.
Koristeći štrcaljku s pričvršćenom iglom, aseptički izvucite 1,5 ml vode za injekcije.
Solutions containing a precipitate should be discarded.
Otopine koje sadrže talog treba baciti.
Acute graft versus host disease Chronic graft versus host disease
Akutna bolest transplantata protiv primatelja Kronična bolest transplantata protiv primatelja
Renal impairment The effects of renal impairment on thiotepa elimination have not been assessed.
Učinci bubrežne disfunkcije na eliminaciju tiotepe nisu ocjenjivani.
After reconstitution with 1.5 ml of water for injections, each ml of solution contains 10 mg thiotepa (10 mg/ml).
Nakon rekonstitucije s 1,5 ml vode za injekcije, svaki ml otopine sadrži 10 mg tiotepe (10 mg/ml).
Blood creatinine increased
Povećanje kreatinina u krvi Povećanje ureje u krvi
TRM values ranged from 0% to 7.4% confirming the safety of the conditioning treatment including thiotepa for autologous HPCT in adult patients with solid tumours.
TRM vrijednosti su u rasponu od 0% do 7,4%, potvrđujući sigurnost pripremnih terapija a tiotepom za autologne TKMS u odraslih bolesnika sa solidnim tumorima.
Ataxia
Ataksija
After reconstitution with 10 ml of water for injections, each ml of solution contains 10 mg thiotepa (10 mg/ml).
Nakon rekonstitucije s 10 ml vode za injekcije, svaki ml otopine sadrži 10 mg tiotepe (10 mg/ml).
One vial contains 15 mg thiotepa.
Jedna bočica sadrži 15 mg tiotepe.
One vial contains 100 mg thiotepa.
Jedna bočica sadrži 100 mg tiotepe.
It is likely that certain adverse reactions of thiotepa like dizziness, headache and blurred vision could affect these functions.
Vjerojatno je da neke nuspojave tiotepe kao što su omglica, glavobolja i zamagljen vid mogu utjecati na navedene sposobnosti.
After reconstitution with 1.5 ml of water for injection, each ml contains 10 mg thiotepa.
Nakon pripreme za primjenu s 1,5 ml vode za injekcije, svaki ml sadrži 10 mg tiotepe.
TRM values ranged from 0% to 21% at 1 year, confirming the safety of the conditioning treatment including thiotepa for autologous HPCT in adult patients with haematological diseases.
TRM vrijednosti su u rasponu od 0% do 21% nakon 1 godine, potvrđujući sigurnost pripremnog liječenja s tiotepom za autologne TKMS u odraslih bolesnika s hematološkim bolestima.
Fertility
Tinitus
Erythema Desquamation Pigmentation disorder
Poremećaji pigmentacije
The recommended dose in lymphoma is 370 mg/m2/day (10 mg/kg/day) divided in two daily infusions before allogeneic HPCT, without exceeding the total maximum cumulative dose of 370 mg/m2
Preporučena doza je 370 mg/m2/dan (10 mg/kg/dan) podijeljena u dvije dnevne infuzije prije alogene TKMS, bez prekoračenja ukupne maksimalne kumulativne doze od 370 mg/m
Concomitant use not recommended
Kontraindicirana istodobna primjena
TEPADINA 100 mg powder for concentrate for solution for infusion
TEPADINA 100 mg prašak za koncentrat za otopinu za infuziju
TEPADINA must be reconstituted with 1.5 ml of sterile water for injection.
TEPADINA se mora rekonstituirati s 1,5 ml sterilne vode za injekcije.
Each TEPADINA vial must be reconstituted with 1.5 ml of sterile water for injection.
Svaka bočica lijeka TEPADINA mora biti rekonstituirana s 1,5 ml sterilne vode za injekcije.
Dizziness Headache Vision blurred Encephalopathy Convulsion Paraesthesia
Omaglica Glavobolja Zamagljen vid Encefalopatija Konvulzije Parestezija
The recommended dose is 370 mg/m2/day (10 mg/kg/day) divided in two daily infusions, administered before allogeneic HPCT, without exceeding the total maximum cumulative dose of 370 mg/m2 (10 mg/kg), during the time of the entire conditioning treatment.
Preporučena doza je 370 mg/m2/dan (10 mg/kg/dan) podijeljena u dvije dnevne infuzije primjenjene prije alogene TKMS, bez prekoračenja ukupne maksimalne kumulativne doze od 370 mg/m (10 mg/kg), tijekom cijelog pripremnog liječenja.
TEPADINA 15 mg powder for concentrate for solution for infusion
TEPADINA 15 mg prašak za koncentrat za otopinu za infuziju
TRM values ranged from 0% to 18% confirming the safety of the conditioning treatments including thiotepa for autologous HPCT in paediatric patients with solid tumours.
TRM vrijednosti su bile u rasponu od 0% do 18%, potvrđujući sigurnost pripremnih terapija s tiotepom za autologne TKMS u pedijatrijskih bolesnika sa solidnim tumorima.
Caution must be used in patients with history of renal diseases and periodic monitoring of renal function should be considered during therapy with thiotepa.
Tijekom terapije s tiotepom, potreban je oprez u bolesnika s anamnezom bolesti bubrega i treba razmotriti periodično praćenje bubrežne funkcije.
Regimen Related Mortality (RRM) and Transplant Related Mortality (TRM): RRM values ranging from 0% to 26.7% have been reported.
Mortalitet vezan za terapiju (RRM - Regimen Related Mortality ) i mortalitet vezan za transplantaciju (TRM - Transplant Related Mortality): prijavljene su RRM vrijednosti u rasponu od 0% do 26,7%.
CENTRAL NERVOUS SYSTEM (CNS) LYMPHOMA The recommended dose is 185 mg/m2/day (5 mg/kg/day) as a single daily infusion, administered for 2 consecutive days before autologous HPCT, without exceeding the total maximum cumulative dose of 370 mg/m2 (10 mg/kg), during the time of the entire conditioning treatment.
LIMFOM SREDIŠNJEG ŽIVČANOG SUSTAVA (CNS) Preporučena doza je 185 mg/kg/dan (5 mg/kg/dan) u jednoj dnevnoj infuziji, primjenjenoj tijekom 2 uzastopna dana prije autologne TKMS, bez prekoračenja ukupne maksimalne kumulativne doze od 370 mg/m
After reconstitution with 10 ml of water for injection, each ml contains 10 mg thiotepa.
Nakon pripreme za primjenu s 10 ml vode za injekcije, svaki ml sadrži 10 mg tiotepe.
Cognitive disorder Cerebral haemorrhage
Zatajenje bubrega Hemoragijski cistitis
20867 Caponago (MB) Italy Tel: +39 02 40700445 adienne@adienne.com
Tel: +39 02 40700445 adienne@adienne.com
The recommended dose ranges from 185 mg/m2/day (5 mg/kg/day) to 481 mg/m2/day (13 mg/kg/day) divided in one or two daily infusions, administered from 1 up to 2 consecutive days before allogeneic HPCT depending on the combination with other chemotherapeutic medicinal products, without exceeding the total maximum cumulative dose of 555 mg/m2 (15 mg/kg), during the time of the entire conditioning treatment.
Preporučena doza je u rasponu od 185 mg/m2/dan (5 mg/kg/dan) do 481 mg/m2/dan (13 mg/kg/dan) podijeljena u jednu ili dvije dnevne infuzije, primijenjene tijekom 1 do 2 uzastopna dana prije alogene TKMS ovisno o kombinaciji s drugim kemoterapijskim lijekovima, bez prekoračenja ukupne maksimalne kumulativne doze od 555 mg/m
The recommended dose is 250 mg/m2/day (10 mg/kg/day) divided in two daily infusions, administered before allogeneic HPCT, without exceeding the total maximum cumulative dose of 250 mg/m2 (10 mg/kg), during the time of the entire conditioning treatment.
Preporučena doza je 250 mg/m2/dan (10 mg/kg/dan) podijeljena u dvije dnevne infuzije primjenjene prije alogene TKMS, bez prekoračenja ukupne maksimalne kumulativne doze od 250 mg/m (10 mg/kg), tijekom cijelog pripremnog liječenja.
The recommended dose ranges from 200 mg/m2/day (8 mg/kg/day) to 250 mg/m2/day (10 mg/kg/day) divided in two daily infusions, administered before allogeneic HPCT without exceeding the total maximum cumulative dose of 250 mg/m2 (10 mg/kg), during the time of the entire conditioning treatment.
Preporučena doza je u rasponu od 200 mg/m2/dan (8 mg/kg/dan) do 250 mg/m2/dan (10 mg/kg/dan) podijeljena u dvije dnevne infuzije, primijenjene prije alogene TKMS, bez prekoračenja ukupne maksimalne kumulativne doze od 250 mg/m
What you need to know before you use TEPADINA Do not use TEPADINA
Što je TEPADINA i za što se koristi Što morate znati prije nego počnete primjenjivati lijek TEPADINA
Investigation
Pretrage
TEPADINA must be reconstituted with 10 ml of sterile water for injection.
TEPADINA se mora rekonstituirati s 10 ml sterilne vode za injekcije.
TRM values ranged from 0% to 30% confirming the safety of the conditioning treatment including thiotepa for allogeneic HPCT in paediatric patients with haematological diseases.
TRM vrijednosti su bile u rasponu od 0% do 30% potvrđujući sigurnost pripremnih terapija s tiotepom za alogene TKMS u pedijatrijskih bolesnika s hematološkim bolestima.
Dysuria Oliguria Renal failure Cystitis Haematuria
Oligurija Zatajenje bubrega Cistitis
TEPADINA is supplied as 15 mg powder for concentrate for solution for infusion.
TEPADINA dolazi u obliku 15 mg praška za koncentrat za otopinu za infuziju.
TEPADINA 100 mg powder for concentrate for solution for infusion Thiotepa
TEPADINA 100 mg prašak za koncentrat za otopinu za infuziju tiotepa
Rash Pruritus Alopecia
Svrbež Alopecija
Engraftment: It has been achieved with all reported conditioning regimens including thiotepa.
Prihvat transplantata: Prihvat je postignut kod svih pripremnih terapija sa tiotepom.
TEPADINA is supplied as 100 mg powder for concentrate for solution for infusion.
TEPADINA dolazi u obliku 100 mg praška za koncentrat za otopinu za infuziju.
Regimen Related Mortality (RRM) and Transplant Related Mortality (TRM): RRM values ranging from 2.5% to 29% have been reported.
Mortalitet vezan za terapiju (RRM - Regimen Related Mortality ) i mortalitet vezan za transplantaciju (TRM - Transplant Related Mortality): prijavljene su RRM vrijednosti u rasponu od 2,5% do 29%.
Hearing impaired
Oštećenje sluha
Regimen Related Mortality (RRM) and Transplant Related Mortality (TRM): RRM values ranging from 0% to 2% have been reported.
Mortalitet vezan za terapiju (RRM - Regimen Related Mortality ) i mortalitet vezan za transplantaciju (TRM - Transplant Related Mortality): prijavljene su RRM vrijednosti u rasponu od 0% do 2%.
Injection site inflammation Injection site pain Mucosal inflammation
Upala na mjestu injiciranja Bol na mjestu injiciranja
PRESENTATION
Primjena
Haemorrhage
TALASEMIJA
TEPADINA 15 mg powder for concentrate for solution for infusion Thiotepa
TEPADINA 15 mg prašak za koncentrat za otopinu za infuziju tiotepa
TEPADINA is used to prepare patients for bone marrow transplantation.
TEPADINA se koristi za pripremu bolesnika za transplantaciju koštane srži; djeluje uništavajući stanice koštane srži.
Disposal
Deskvamacija
ALLOGENEIC HPCT
ALOGENA TKMS
Allogeneic HPCT
Alogena TKMS
Preparation of TEPADINA
Priprema lijeka TEPADINA
Tachycardia Cardiac failure
Tahikardija Zatajivanje srca
SICKLE CELL ANAEMIA
Pireksija Astenija Zimica
How to store TEPADINA
Kako čuvati lijek TEPADINA
Intracranial aneurysm Extrapyramidal disorder
Intrakranijska aneurizma Ekstrapiramidni poremećaji Kognitivni poremećaji Cerebralno krvarenje
The recommended dose in haematological diseases ranges from 125 mg/m2/day (3.38 mg/kg/day) to 300 mg/m2/day (8.10 mg/kg/day) as a single daily infusion, administered from 2 up to 4 consecutive days before autologous HPCT depending on the combination with other chemotherapeutic medicinal products, without exceeding the total maximum cumulative dose of 900 mg/m2 (24.32 mg/kg), during the time of the entire conditioning treatment.
LIMFOM Preporučena doza je u rasponu od 125 mg/m2/dan (3,38 mg/kg/dan) do 300 mg/m2/dan (8,10 mg/kg/dan) u jednoj dnevnoj infuziji, primjenjenoj tijekom 2 do 4 uzastopna dana prije autologne TKMS ovisno o kombinaciji s drugim kemoterapijskim lijekovima, bez prekoračenja ukupne maksimalne kumulativne doze od 900 mg/m
Regimen Related Mortality (RRM) and Transplant Related Mortality (TRM): RRM values ranging from 0% to 2.5% have been reported.
Mortalitet vezan za terapiju (RRM - Regimen Related Mortality ) i mortalitet vezan za transplantaciju (TRM - Transplant Related Mortality): prijavljene su RRM vrijednosti u rasponu od 0% do 2,5%.
The recommended dose ranges from 125 mg/m2/day (3.38 mg/kg/day) to 250 mg/m2/day (6.76 mg/kg/day) divided in one or two daily infusions, administered from 3 up to 4 consecutive days before autologous HPCT depending on the combination with other chemotherapeutic medicinal products, without exceeding the total maximum cumulative dose of 750 mg/m2 (20.27 mg/kg), during the time of the entire conditioning treatment.
Preporučena doza je u rasponu od 125 mg/m2/dan (3,38 mg/kg/dan) do 250 mg/m2/dan (6,76 mg/kg/dan) podijeljena u jednu ili dvije dnevne infuzije, primijenjene tijekom 3 do 4 uzastopnih dana prije autologne TKMS ovisno o kombinaciji s drugim kemoterapijskim lijekovima, bez prekoračenja ukupne maksimalne kumulativne doze od 750 mg/m
Cataract
Katarakta
The recommended dose is 125 mg/m2/day (5 mg/kg/day) as a single daily infusion, administered for 3 consecutive days before allogeneic HPCT, without exceeding the total maximum cumulative dose of 375 mg/m2 (15 mg/kg), during the time of the entire conditioning treatment.
REFRAKTORNA CITOPENIJA Preporučena doza je 125 mg/m2/dan (5 mg/kg/dan) u jednoj dnevnoj infuziji, primjenjenoj tijekom 3 uzastopna dana prije alogene TKMS, bez prekoračenja ukupne maksimalne kumulativne doze 375 mg/m
The recommended dose in solid tumours ranges from 150 mg/m2/day (6 mg/kg/day) to 350 mg/m2/day (14 mg/kg/day) as a single daily infusion, administered from 2 up to 3 consecutive days before autologous HPCT depending on the combination with other chemotherapeutic medicinal products, without exceeding the total maximum cumulative dose of 1050 mg/m2 (42 mg/kg), during the time of the entire conditioning treatment.
Preporučena doza je u rasponu od 150 mg/m2/dan (6 mg/kg/dan) do 350 mg/m2/dan (14 mg/kg/dan) u jednoj dnevnoj infuziji, primjenjenoj tijekom 2 do 3 uzastopna dana prije autologne TKMS ovisno o kombinaciji s drugim kemoterapijskim lijekovima, bez prekoračenja ukupne maksimalne kumulativne doze od 1050 mg/m
The recommended dose is 125 mg/m2/day (5 mg/kg/day) as a single daily infusion, administered for 2 consecutive days before allogeneic HPCT, without exceeding the total maximum cumulative dose of 250 mg/m2 (10 mg/kg), during the time of the entire conditioning treatment.
Preporučena doza je 125 mg/m2/dan (5 mg/kg/dan) u jednoj dnevnoj infuziji, primjenjenoj tijekom 2 uzastopna dana prije alogene TKMS, bez prekoračenja ukupne maksimalne kumulativne doze 250 mg/m
Each TEPADINA vial must be reconstituted with 10 ml of sterile water for injection.
Rekonstitucija TEPADINA se mora rekonstituirati s 10 ml sterilne vode za injekcije.