FrancophonIA/ELRC3.0 huggingface dataset:
English: 20867 Caponago (MB) Italy adienne@adienne.com
Danish: 20867 Caponago (MB) Italien adienne@adienne.com
English: 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.
Danish: Mandlige patienter bør opsøge præservering af sæd, inden behandling påbegyndes, og må ikke få børn, mens de behandles, og i et år efter ophør af behandlingen.
English: Due to its highly myeloablative characteristics, thiotepa enhances recipient immunosuppression and myeloablation, thus strengthening engraftment; this compensates for the loss of the GvHD-related GvL effects.
Danish: Som følge af dets særdeles myeloablative egenskaber forbedrer thiotepa immunsuppression og myeloablation hos modtageren, hvilket styrker engraftment.
English: Name and address of the manufacturer(s) responsible for batch release
Danish: Navn og adresse på den fremstiller (de fremstillere), der er ansvarlig(e) for batchfrigivelse RIEMSER Pharma GmbH
English: (10 mg/kg), during the time of the entire conditioning treatment.
Danish: (10 mg/kg) overskrides under hele konditioneringen.
English: Azoospermia Amenorrhoea Vaginal haemorrhage
Danish: Azoospermi Amenoré Vaginal blødning
English: Pigmentation disorder Erythrodermic psoriasis
Danish: Pigmentforandringer Erytrodermisk psoriasis
English: Type I clear glass vial with a rubber stopper (bromobutyl or chlorobutyl), containing 15 mg thiotepa.
Danish: Klart hætteglas af type I med gummiprop (bromobutyl eller klorobutyl) indeholdende 15 mg thiotepa.
English: What you need to know before you use TEPADINA 3.
Danish: Det skal du vide, før du begynder at bruge TEPADINA
English: Any unused product or waste material should be disposed of in accordance with local requirements.
Danish: Ikke anvendte lægemidler eller affald heraf bør destrueres i henhold til lokale retningslinjer.
English: After reconstitution the product is stable for 8 hours when stored at 2°C -8°C.
Danish: Efter rekonstitution er lægemidlet stabilt i otte timer, hvis det opbevares ved 2 °C - 8 °C.
English: The most serious side effects of TEPADINA therapy or the transplant procedure may include - decrease in circulating blood cell counts (intended effect of the medicine to prepare you for your transplant infusion) - infection - liver disorders including blocking of a liver vein - the graft attacks your body (graft versus host disease) - respiratory complications
Danish: De alvorligste bivirkninger ved TEPADINA-behandling eller transplantationsproceduren kan omfatte - fald i antallet af blodlegemer (tilsigtet virkning af medicinen for at forberede dig til din transplantation)
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Danish: Du kan finde yderligere information om dette lægemiddel på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: Multi-organ failure Pain
Danish: Multiorgansvigt Smerte
English: Menopausal symptoms Infertility female Infertility male
Danish: Infertilitet, kvinde Infertilitet, mand
English: Type I clear glass vial with a rubber stopper (bromobutyl or buthyl), containing 100 mg thiotepa.
Danish: Klart hætteglas af type I med gummiprop (bromobutyl eller butyl) indeholdende 100 mg thiotepa.
English: Thiotepa has not been studied in patients with hepatic impairment.
Danish: Thiotepa er ikke undersøgt hos patienter med nedsat leverfunktion.
English: It is likely that certain adverse events of thiotepa like dizziness, headache and blurred vision could affect your ability to drive and use machines.
Danish: Det er sandsynligt, at visse uønskede hændelser ved thiotepa, som f.eks. svimmelhed, hovedpine og sløret syn, kan påvirke din evne til at føre motorkøretøj eller betjene maskiner.
English: It is likely that certain adverse reactions of thiotepa like dizziness, headache and blurred vision could affect your ability to drive and use machines.
Danish: Det er sandsynligt, at visse uønskede reaktioner ved thiotepa, som f.eks. svimmelhed, hovedpine og sløret syn, kan påvirke din evne til at føre motorkøretøj eller betjene maskiner.
English: Overall Survival (OS): OS ranged from 50% to 100% with a follow-up ranging from 9.4 up to 121 months.
Danish: Overall survival (OS): Den samlede overlevelse varierede fra 50 % til 100 % med en opfølgningsperiode, der varierede fra 9,4 til 121 måneder.
English: If thiotepa accidentally contacts mucous membranes, they must be flushed thoroughly with water (see section
Danish: Hvis thiotepa utilsigtet kommer i kontakt med slimhinderne, skal de skylles grundigt med vand (se pkt.
English: Male patients should seek for sperm cryopreservation before therapy is started and should not father a child while treated and during the year after cessation of treatment (see section 5.3).
Danish: Mandlige patienter bør forsøge kryopræservering af sæd, inden behandling påbegyndes, og må ikke få børn, mens de behandles, og i et år efter ophør af behandlingen (se pkt.
English: After reconstitution, each ml contains 10 mg thiotepa (10 mg/ml).
Danish: Efter rekonstitution indeholder hver ml 10 mg thiotepa (10 mg/ml).
English: Haematological diseases
Danish: Hæmatologiske sygdomme
English: Venoocclusive liver disease
Danish: Venookklusiv leversygdom
English: Engraftment: Conditioning treatments including thiotepa have proved to be myeloablative.
Danish: Engraftment: Konditioneringer, der omfatter thiotepa, har vist sig at være myeloablative.
English: TEPADINA is a white crystalline powder supplied in a glass vial containing 15 mg thiotepa.
Danish: TEPADINA er et hvidt, krystallinsk pulver, som leveres i et hætteglas, der indeholder 15 mg thiotepa.
English: If thiotepa accidentally contacts mucous membranes, they must be flushed thoroughly with water.
Danish: Hvis thiotepa utilsigtet kommer i kontakt med slimhinderne, skal de skylles grundigt med vand.
English: LYMPHOMA
Danish: LYMFOMER
English: TEPADINA is a white crystalline powder supplied in a glass vial containing 100 mg thiotepa.
Danish: TEPADINA er et hvidt, krystallinsk pulver, som leveres i et hætteglas, der indeholder 100 mg thiotepa.
English: Thrombocytopenia Febrile neutropenia Anaemia
Danish: Trombocytopeni Febril neutropeni Anæmi
English: LYMPHOMA The recommended dose ranges from 125 mg/m2/day (3.38 mg/kg/day) to 300 mg/m2/day
Danish: Den anbefalede dosis ved hæmatologiske sygdomme varierer fra 125 mg/m 2/dag (3,38 mg/kg/dag) til
English: Uncommon side effects (may affect up to 1 in 100 people) - inflammation and exfoliation of the skin (erythrodermic psoriasis) - delirium, nervousness, hallucination, agitation - gastrointestinal ulcer - inflammation of the muscular tissue of the heart (myocarditis) - abnormal heart condition (cardiomyopathy)
Danish: Ikke almindelige bivirkninger (kan forekomme hos op til 1 ud af 100 personer) - betændelse i huden og afskalning af huden (erytrodermisk psoriasis) - delirium, nervøsitet, hallucination, uro - mavesår - betændelse i hjertets muskelvæv (myocarditis) - abnorm hjertetilstand (kardiomyopati)
English: Linearity /non linearity There is no clear evidence of saturation of metabolic clearance mechanisms at high doses of thiotepa.
Danish: Der er ingen tydelige beviser på mætning af metaboliske clearance-mekanismer ved høje doser af thiotepa.
English: Accord-UK Ltd Tel: +44 (0)1271 385257
Danish: United Kingdom Accord-UK Ltd Tel: +44 (0)1271 385257
English: Overall Survival (OS): OS ranged from 17% to 84% with a follow-up ranging from 12.3 up to 99.6 months.
Danish: Overall survival (OS): Den samlede overlevelse varierede fra 17 % til 84 % med en opfølgningsperiode, der varierede fra 12,3 til 99,6 måneder.
English: After intravenous administration, CSF medicinal product exposure is nearly equivalent to that achieved in plasma; the mean ratio of AUC in CSF to plasma for thiotepa is 0.93.
Danish: Efter intravenøs indgivelse svarer eksponeringen for CSF-lægemidlet næsten til den, der opnås i plasma.
English: Overall Survival (OS): OS ranged from 29% to 87% with a follow-up ranging from 22 up to 63 months.
Danish: Overall survival (OS): Den samlede overlevelse varierede fra 29 % til 87 % med en opfølgningsperiode, der varierede fra 22 til 63 måneder.
English: How to use TEPADINA
Danish: Sådan skal du bruge TEPADINA
English: AUTOLOGOUS HPCT
Danish: AUTOLOG HPCT
English: Venoocclusive liver disease Hepatomegaly Jaundice
Danish: Venookklusiv leversygdom Hepatomegali Gulsot
English: Topical reactions associated with accidental exposure to thiotepa may occur.
Danish: Der kan forekomme topikale virkninger efter utilsigtet eksponering for thiotepa.
English: Hypoxia
Danish: Hypoksi
English: Chemical and physical in-use stability after reconstitution has been demonstrated for 8 hours when stored at 2°C-8°C.
Danish: Kemisk og fysisk stabilitet efter rekonstitution er blevet påvist i otte timer ved opbevaring ved 2 °C8 °C.
English: Pack size of 1 vial.
Danish: Pakning med ét hætteglas.
English: DFS results confirm that conditioning treatment containing thiotepa following allogeneic HPCT are effective therapeutic strategies for treating paediatric patients with haematological diseases.
Danish: Resultaterne for sygdomsfri overlevelser bekræfter, at konditionering, der omfatter thiotepa efter allogen HPCT, er effektive behandlingsstrategier til behandling af børn med hæmatologiske sygdomme.
English: Decreased appetite Hyperglycaemia
Danish: Anoreksi Nedsat appetit Hyperglykæmi
English: Hepatic impairment The effects of hepatic impairment on thiotepa metabolism and elimination have not been assessed.
Danish: Leverinsufficiens: Virkningen af leverinsuffiens på metabolisering og eliminering af thiotepa er ikke blevet vurderet.
English: Solid tumours
Danish: Solide tumorer
English: 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.
Danish: Sygdomsfri overlevelse: De rapporterede procentdele med opfølgningsperioder på mere end ét år og op til fem år bekræfter, at konditioneringer, der omfatter thiotepa efter allogen HPCT, er effektive valg til behandling af patienter med hæmatologiske sygdomme.
English: Aspartate aminotransferase increased
Danish: Forhøjede aminotransferase r
English: The adverse reactions considered at least possibly related to conditioning treatment including thiotepa, reported in adult patients as more than an isolated case, are listed below by system organ class and by frequency.
Danish: De bivirkninger, som i det mindste med en vis sandsynlighed kan henføres til konditionerende behandling, der inkluderer thiotepa, og som blev rapporteret hos voksne i mere end et isoleret tilfælde, er anført nedenfor efter organklasse og hyppighed.
English: Deutschland
Danish: Tyskland
English: 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.
Danish: Sygdomsfri overlevelse: En estimeret andel på 43 % efter fem år er rapporteret, hvilket bekræfter, at konditioneringer, der omfatter thiotepa efter autolog HPCT, er effektive behandlingsstrategier til behandling af patienter med hæmatologiske sygdomme.
English: Headache Encephalopathy Convulsion Cerebral haemorrhage Memory impairment Paresis
Danish: Hovedpine Encefalopati Krampe Hjerneblødning Nedsat hukommelse Parese
English: Tachycardia Cardiac failure
Danish: Takykardi Hjertesvigt
English: This enables the transplantation of new bone marrow cells (haematopoietic progenitor cells), which in turn enable the body to produce healthy blood cells.
Danish: Det fungerer ved at ødelægge knoglemarvsceller, hvilket muliggør transplantation af nye knoglemarvsceller (hæmatopoietiske progenitorceller).
English: Overall Survival: OS ranged from 30% to 87% with a follow-up ranging from 11.7 up to 87 months.
Danish: Overall survival (OS): Den samlede overlevelse varierede fra 30 % til 87 % med en opfølgningsperiode, der varierede fra 11,7 til 87 måneder.
English: 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.
Danish: Sygdomsfri overlevelse: De rapporterede procentdele med opfølgningsperioder på mere end ét år bekræfter, at konditioneringer, der omfatter thiotepa efter autolog HPCT, er effektive valg til behandling af patienter med solide tumorer.
English: 20867 Caponago (MB) Italy Tel: +39-02 40700445 adienne@adienne.com
Danish: 20867 Caponago (MB) Italien Tel: +39-02 40700445 adienne@adienne.com
English: Overall Survival: OS ranged from 31% to 81% with a follow-up ranging from 7.3 up to 120 months.
Danish: Overall survival (OS): Den samlede overlevelse varierede fra 31 % til 81 % med en opfølgningsperiode, der varierede fra 7,3 til 120 måneder.
English: - If you have any further questions, ask your doctor.
Danish: - Spørg lægen eller på apoteket, hvis der er mere, du vil vide.
English: 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.
Danish: Tilbagefald: For alle konditioneringer, der omfatter thiotepa, er tilbagefaldsprocenten efter mere end ét år rapporteret til at være 60 % eller lavere, som efter lægelig vurdering er tærskelen for påvisning af effekt.
English: Preparation of TEPADINA
Danish: Klargøring af TEPADINA
English: 20867 Caponago (MB) Italy Tel: +39 02 40700445 adienne@adienne.com
Danish: 20867 Caponago (MB) Italien Tel : +39 02 40700445 adienne@adienne.com
English: Cardiovascular insufficiency Cardiac failure
Danish: Kardiovaskulær insuffiens Hjertesvigt
English: - anxiety, confusion - abnormal bulging outward of one of the arteries in the brain (intracranial aneurysm) - creatinine elevated - allergic reactions - occlusion of a blood vessel (embolism) - heart rhythm disorder - heart inability - cardiovascular inability - oxygen deficiency - fluid accumulation in the lungs (pulmonary oedema) - pulmonary bleeding - respiratory arrest - blood in the urine (haematuria) and moderate renal insufficiency - inflammation of the urinary bladder - discomfort in urination and decrease in urine output (disuria and oliguria) - increase in the amount of nitrogen components in the blood stream (BUN increase) - cataract - inability of the liver - cerebral haemorrhage - cough - constipation and upset stomach - obstruction of the bowel - perforation of stomach - changes in muscle tone - gross lack of coordination of muscle movements - bruises due to a low platelet count - menopausal symptoms - cancer (second primary malignancies) - abnormal brain function - male and female infertility
Danish: Almindelige bivirkninger (kan forekomme hos 1 ud af 10 personer) - angst, forvirring - abnorm hævelse af pulsårer i hjernen (hjerneaneurisme) - øget kreatinin-niveau - allergiske reaktioner - tillukning af blodkar (embolisme) - hjerterytmeforstyrrelse - hjertesvigt - kardiovaskulære forstyrrelser - iltmangel - væskeansamling i lungerne (lungeødemer) - pulmonær blødning - åndedrætsstop - blod i urinen (hæmaturi) og moderat nyreinsufficiens - blærebetændelse - ubehag ved vandladning og nedsat urinproduktion - øget mængde nitrogenforbindelser i blodbanen - katarakt - leverinsufficiens - hjerneblødning - hoste - forstoppelse og maveproblemer - tarmobstruktion - maveperforation - muskelændringer - udtalt mangel på koordination af muskelbevægelser - skrammer som følge af et lavt antal blodplader - menopausale symptomer - kræft (andre primære maligniteter) - abnorm hjernefunktion - infertilitet hos mænd og kvinder
English: 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).
Danish: Det totale volumen af de rekonstituerede hætteglas, der skal administreres, skal yderligere fortyndes med 500 ml natriumchlorid 9 mg/ml (0,9 %) injektionsvæske før indgivelse (1000 ml, hvis dosis er højere end 500 mg).
English: After dilution the product is stable for 24 hours when stored at 2°C -8°C and for 4 hours when stored at 25°C.
Danish: Efter fortynding er lægemidlet stabilt i 24 timer, hvis det opbevares ved 2 °C - 8 °C, og i 4 timer, hvis det opbevares ved 25 °C.
English: For storage conditions of the reconstituted and diluted medicinal product, see section 6.3.
Danish: Efter rekonstitution og fortynding: Opbevaringsforhold efter rekonstitution og fortynding af lægemidlet, se pkt.
English: Elimination
Danish: Destruktion
English: 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.
Danish: Tilbagefald: For alle konditioneringer, der omfatter thiotepa, er tilbagefaldsprocenten efter mere end ét år rapporteret til at være lavere end 60 %, som efter lægelig vurdering er tærskelen for påvisning af effekt.
English: TEPADINA can impair male and female fertility.
Danish: TEPADINA kan nedsætte fertiliteten hos mænd og kvinder.
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Danish: De alvorligste bivirkninger er anført først inden for hver hyppighedsgruppe.
English: LEUKAEMIA
Danish: LEUKÆMI
English: GENETIC DISEASES
Danish: Vaskulære sygdomme
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Danish: Hvis du vil have yderligere oplysninger om TEPADINA, skal du henvende dig til den lokale repræsentant:
English: TEPADINA is supplied as 100 mg powder for concentrate for solution for infusion.
Danish: TEPADINA leveres som 100 mg pulver til koncentrat til infusionsvæske, opløsning.
English: TEPADINA is supplied as 15 mg powder for concentrate for solution for infusion.
Danish: TEPADINA leveres som 15 mg pulver til koncentrat til infusionsvæske, opløsning.
English: Relapse: In all conditioning treatments containing thiotepa, relapse rates at more than 1 year have been reported as being lower than 40% (which was considered by the physicians as the threshold to prove efficacy).
Danish: Tilbagefald: For alle konditioneringer, der omfatter thiotepa, er tilbagefaldsprocenten efter mere end ét år rapporteret til at være lavere end 40 %, som efter lægelig vurdering er tærskelen for påvisning af effekt.
English: Stomatitis Vomiting Diarrhoea Abdominal pain
Danish: Kvalme Stomatitis Opkastning Diarré
English: Chemical and physical in-use stability after dilution has been demonstrated for 24 hours when stored at 2°C-8°C and for 4 hours when stored at 25°C.
Danish: Kemisk og fysisk stabilitet efter fortynding er blevet påvist i 24 timer ved opbevaring ved 2 °C-8 °C og i 4 timer, hvis det opbevares ved 25°C .
English: Blood amylase increased
Danish: Forhøjede aminotransferaser Forhøjet amylase i blodet
English: Blood creatinine increased
Danish: Forhøjet blodkreatinin Forhøjet urinstof i blodet
English: TEPADINA must be reconstituted with 1.5 ml of sterile water for injection.
Danish: TEPADINA skal rekonstitueres med 1,5 ml sterilt vand til injektion.
English: Thiotepa Read this guide prior to the preparation and administration of TEPADINA.
Danish: Læs denne vejledning før klargøring og indgivelse af TEPADINA.
English: Dizziness Headache Vision blurred Encephalopathy Convulsion Paraesthesia
Danish: Svimmelhed Hovedpine Sløret syn Encefalopati Krampe Paræstesi
English: After reconstitution with 1.5 ml of water for injection, each ml contains 10 mg thiotepa.
Danish: Efter rekonstitution med 1,5 ml vand til injektion indeholder hver ml 10 mg thiotepa.
English: In children, if the dose is lower than 250 mg, an appropriate volume of sodium chloride 9 mg/ml (0.9%) solution for injection may be used in order to obtain a final TEPADINA concentration between 0.5 and 1 mg/ml.
Danish: Til børn kan der benyttes et passende volumen natriumchlorid 9 mg/ml (0,9 %) injektionsvæske til at opnå en endelig TEPADINA-koncentration på mellem 0,5 og 1 mg/ml, hvis dosis er lavere end 250 mg. Se pkt.
English: One vial of powder contains 100 mg thiotepa.
Danish: Et hætteglas med pulver indeholder 100 mg thiotepa.
English: One vial of powder contains 15 mg thiotepa.
Danish: Et hætteglas med pulver indeholder 15 mg thiotepa.
English: 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.
Danish: Den rekonstituerede opløsning er hypotonisk og skal fortyndes yderligere med 500 ml natriumchlorid 9 mg/ml (0,9 %) injektionsopløsning før indgivelse (1000 ml, hvis dosis er højere end 500 ml) eller med en passende mængde natriumchlorid 9 mg/ml (0.9 %) til at opnå en endelig TEPADINAkoncentration på mellem 0,5 og 1 mg/ml.
English: After reconstitution with 10 ml of water for injection, each ml contains 10 mg thiotepa.
Danish: Efter rekonstitution med 10 ml vand til injektion indeholder hver ml 10 mg thiotepa.
English: GERM CELL TUMOURS
Danish: Mave-tarm-kanalen
English: Blood urea increased Blood electrolytes abnormal Prothrombin time ratio increased
Danish: Abnorme blodelektrolytter Forlænget protrombintid
English: Injection site inflammation Injection site pain Mucosal inflammation
Danish: Kuldegysninger Generelt ødem Betændelse ved injektionsstedet Smerter på injektionsstedet Slimhindeinflammation
English: TEPADINA must be reconstituted with 10 ml of sterile water for injection.
Danish: TEPADINA skal rekonstitueres med 10 ml sterilt vand til injektion.
English: One vial contains 15 mg thiotepa.
Danish: Et hætteglas indeholder 15 mg thiotepa.
English: Haemorrhage
Danish: Rygsmerter
English: Hepatobiliary disorders
Danish: Menopausale symptomer
English: Accord Healthcare B.V. Tel: +31 30 850 6014
Danish: Tel: +31 30 850 6014
English: The recommended dose is 185 mg/m2/day (5 mg/kg/day) as a single daily infusion before allogeneic HPCT, without exceeding the total maximum cumulative dose of 185 mg/m2 (5 mg/kg), during the time of the entire conditioning treatment.
Danish: Den anbefalede dosis er 185 mg/m2/dag (5 mg/kg/dag) som en enkelt daglig infusion, der indgives før allogen HPCT, uden at den totale maksimale kumulerede dosis på 185 mg/m
English: After reconstitution with 10 ml of water for injections, each ml of solution contains 10 mg thiotepa (10 mg/ml).
Danish: Efter rekonstitution med 10 ml vand til injektioner indeholder hver ml opløsning 10 mg thiotepa (10 mg/ml).
English: One vial contains 100 mg thiotepa.
Danish: Et hætteglas indeholder 100 mg thiotepa.
English: 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.
Danish: Den anbefalede dosis varierer fra 200 mg/m2/dag (8 mg/kg/dag) til 250 mg/m2/dag (10 mg/kg/dag) fordelt på to daglige infusioner, der indgives før allogen HPCT, uden at den totale maksimale kumulerede dosis på 250 mg/m
English: Rash Pruritus Alopecia
Danish: Udslæt Kløe Alopeci
English: Regimen Related Mortality (RRM) and Transplant Related Mortality (TRM): RRM values ranging from 0% to 26.7% have been reported.
Danish: Behandlingsrelateret mortalitet (BRM) og transplantationsrelateret mortalitet (TRM): Der er rapporteret BRM-værdier fra 0 % til 26,7 %.
English: After reconstitution with 1.5 ml of water for injections, each ml of solution contains 10 mg thiotepa (10 mg/ml).
Danish: Efter rekonstitution med 1,5 ml vand til injektioner indeholder hver ml opløsning 10 mg thiotepa (10 mg/ml).