FrancophonIA/ELRC3.0 huggingface dataset:
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.
Croatian: Nuspojave za koje se smatra da su vjerojatno povezane s pripremnom terapijom s tiotepom, prijavljene u odraslih bolesnika u više od jednog izoliranog slučaja, su navedene prema klasifikaciji organskih sustava i njihovoj učestalosti.
English: Thrombocytopenic purpura
Croatian: Trombocitopenična purpura
English: Precautions to be taken before handling or administering the medicinal product Topical reactions associated with accidental exposure to thiotepa may occur.
Croatian: Potreban je oprez pri rukovanju ili primjeni lijeka Može doći do površinskih reakcija nakon slučajnog izlaganja tiotepi.
English: Venoocclusive liver disease Hepatomegaly Jaundice
Croatian: Veno-okluzivna bolest jetre Hepatomegalija Žutica
English: SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING
Croatian: POSEBNE MJERE ZA ZBRINJAVANJE I DRUGA RUKOVANJA LIJEKOM
English: Headache Encephalopathy Convulsion Cerebral haemorrhage Memory impairment Paresis
Croatian: Glavobolja Encefalopatija Konvulzije Cerebralno krvarenje Oštećenje funkcije pamćenja Pareza
English: Frequent complete blood counts, including differential white blood cell counts, and platelet counts need to be performed during the treatment and until recovery is achieved.
Croatian: Tijekom liječenja i sve do oporavka treba često raditi kompletnu krvnu sliku, uključujući diferencijalnu krvnu sliku i određivanje broja trombocita.
English: Intravenous use, after reconstitution and dilution.
Croatian: Za primjenu u venu, nakon pripreme za primjenu i razrjeđivanja.
English: TEPADINA can impair male and female fertility.
Croatian: TEPADINA može oštetiti mušku i žensku plodnost.
English: Caution must be used in patients with history of cardiac diseases, and cardiac function must be monitored regularly in patients receiving thiotepa.
Croatian: U bolesnika s poviješću srčanih bolesti preporučuje se oprez, kao i redovito praćenje srčane funkcije bolesnika liječenih sa tiotepom.
English: Hepatic impairment The effects of hepatic impairment on thiotepa metabolism and elimination have not been assessed.
Croatian: Učinci jetrene disfunkcije na metabolizam i eliminaciju tiotepe nisu ocjenjivani.
English: Metabolism and nutrition disorders Anorexia Hyperglycaemia
Croatian: Poremećaji metabolizma i prehrane Anoreksija Hiperglikemija
English: Stomatitis Oesophagitis Vomiting Diarrhoea Dyspepsia Abdominal pain Enteritis Colitis
Croatian: Mučnina Stomatitis Ezofagitis Povraćanje Proljev Dispepsija Bolovi u abdomenu Enteritis Kolitis
English: Relapse: In all the reported conditioning regimens containing thiotepa, the relapse rate was in the range of 15% - 44%.
Croatian: Recidiv: Uz sva pripremna liječenja s tiotepom zabilježene su stope recidiva koje su bile u rasponu od 15% do 44%.
English: Blood urea increased Blood electrolytes abnormal Prothrombin time ratio increased
Croatian: Abnormalne razine elektrolita u krvi Povećanje u omjeru protrombinskog vremena
English: Accord-UK Ltd Tel: +44 (0)1271 385257
Croatian: United Kingdom Accord-UK Ltd Tel: +44 (0)1271 385257
English: Pack size of 1 vial.
Croatian: Veličina pakiranja: 1 bočica
English: The increased risk of a secondary malignancy with thiotepa, a known carcinogen in humans, must be explained to the patient.
Croatian: Bolesnik treba biti informiran o povećanom riziku za razvoj drugog malignog tumora uzrokovanog korištenjem tiotepe, koji je poznat kao ljudski karcinogen.
English: Overall Survival (OS): OS ranged from 17% to 84% with a follow-up ranging from 12.3 up to 99.6 months.
Croatian: Sveukupno preživljenje (OS - Overall Survival): OS je bio u rasponu od 17% do 84% uz period praćenja u rasponu od 12,3 do 99,6 mjeseci.
English: Pancytopenia Granulocytopenia
Croatian: Pancitopenija Granulocitopenija
English: Chemical and physical in-use stability after reconstitution has been demonstrated for 8 hours when stored at 2°C-8°C.
Croatian: Dokazana je kemijska i fizikalna stabilnost lijeka nakon rekonstitucije tijekom 8 sati ako se čuva na 2°C - 8°C.
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
Croatian: Česte nuspojave (mogu se javiti u manje od 1 na 10 osoba) - tjeskoba, smetenost - abnormalno ispupčenje prema van jedne od arterija mozga (intrakranijska aneurizma) - povišeni kreatinin - alergijske reakcije - začepljenje krvnih žila (embolija) - poremećaji srčanog ritma - slabljenje srčane funkcije - slabljenje kardiovaskularne funkcije - nedostatak kisika - nakupljanje tekućine u plućima (plućni edem) - plućno krvarenje - otkazivanje pluća - krv u mokraći (hematurija) i umjereno oštećenje bubrega - upala mokraćnog mjehura - nelagoda pri mokrenju i smanjena količina mokraće (dizurija i oligurija) - povećanje količine dušičnih spojeva u krvi - katarakta - slabljenje jetrene funkcije - moždano krvarenje - kašalj - zatvor i nadražen želudac - crijevna opstrukcija - puknuće želuca - promjena mišićnog tonusa - nedostatak koordinacije mišićnih pokreta - modrice zbog niskog broja trombocita - simptomi menopauze - rak (druga primarna zloćudna bolest) - abnormalan rad mozga - muška i ženska neplodnost
English: Menopausal symptoms Infertility female Infertility male
Croatian: Simptomi menopauze Ženska neplodnost Muška neplodnost
English: If thiotepa accidentally contacts mucous membranes, they must be flushed thoroughly with water (see section
Croatian: Ako tiotepa slučajno dođe u dodir sa sluznicama, one se moraju temeljito isprati sa vodom (vidjeti dio 6.6).
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).
Croatian: Bolesnicima muškog spola se preporučuje zamrzavanje sperme prije početka terapije, kao i da ne dovode do oplodnje tijekom liječenja te u godini koja slijedi nakon prekida liječenja (vidjeti dio 5.3).
English: LYMPHOMA The recommended dose ranges from 125 mg/m2/day (3.38 mg/kg/day) to 300 mg/m2/day
Croatian: Preporučena doza kod hematoloških bolesti je u rasponu od 125 mg/m2/dan (3,38 mg/kg/dan) do
English: TEPADINA posology is reported, in adult and paediatric patients, according to the type of HPCT (autologous or allogeneic) and disease.
Croatian: Potrebno doziranje lijeka TEPADINA kod odraslih i pedijatrijskih bolesnika ovisi o tipu TKMS (autologna ili alogena) i bolesti.
English: Overall Survival (OS): OS ranged from 29% to 87% with a follow-up ranging from 22 up to 63 months.
Croatian: Sveukupno preživljenje (OS - Overall Survival): OS je bio u rasponu od 29% do 87% uz period praćenja u rasponu od 22 do 63 mjeseca.
English: For storage conditions of the reconstituted and diluted medicinal product, see section 6.3.
Croatian: Uvjete čuvanja rekonstituiranog i razrijeđenog lijeka vidjeti u dijelu 6.3. 6.5 Vrsta i sadržaj spremnika
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)
Croatian: Manje česte nuspojave (mogu se javiti u manje od 1 na 100 osoba) - upala i ljuštenje kože (eritrodermička psorijaza) - delirij, nervoza, halucinacije, uznemirenost - čir u probavnom sustavu - upala mišićnog tkiva srca (miokarditis) - abnormalno stanje srca (kardiomiopatija)
English: Autologous HPCT
Croatian: AUTOLOGNA TKMS
English: AUTOLOGOUS HPCT
Croatian: Autologna TKMS
English: After reconstitution the product is stable for 8 hours when stored at 2°C -8°C.
Croatian: Nakon pripreme za primjenu, lijek je stabilan 8 sati ako se čuva na 2-8°C.
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.
Croatian: Nakon razrjeđivanja, lijek je stabilan 24 sata ako se čuva na 2°C-8°C, te 4 sata ako se čuva na 25°C.
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 4.6).
Croatian: Bolesnicima muškog spola se preporučuje zamrzavanje sperme prije početka terapije, kao i da ne dovode do oplodnje tijekom liječenja te u godini koja slijedi nakon prekida liječenja (vidjeti dio 4.6).
English: Prior to and following each infusion, the indwelling catheter line should be flushed with approximately 5 ml sodium chloride 9 mg/ml (0.9%) solution for injection.
Croatian: Prije i nakon svake infuzije, isperite trajni kateter s približno 5 ml otopine natrijevog klorida 9 mg / ml (0,9%) za injekcije.
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).
Croatian: Recidiv: U svim pripremnim liječenjima s tiotepom zabilježene su stope recidiva koje su nakon više od godinu dana iznosile manje od 40% (što po mišljenju liječnika predstavlja prag koji pokazuje djelotvornost).
English: Thiotepa has not been studied in patients with hepatic impairment.
Croatian: Tiotepa nije proučavana u bolesnika s oštećenjem funkcije jetre.
English: How to use TEPADINA 4.
Croatian: Kako primjenjivati lijek TEPADINA 4 Moguće nuspojave
English: If thiotepa solution accidentally contacts the skin, the skin must be immediately thoroughly washed with soap and water.
Croatian: Ako otopina tiotepe slučajno dođe u dodir s kožom, koža se mora odmah temeljito oprati sa sapunom i vodom.
English: LYMPHOMA
Croatian: LIMFOM
English: Lymphoedema Hypertension
Croatian: Limfedem Hipertenzija
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.
Croatian: Dokazana je kemijska i fizikalna stabilnost lijeka nakon razrjeđivanja tijekom 24 sata ako se čuva na 2°C - 8°C, te tijekom 4 sata ako se čuva na 25°C.
English: Topical reactions associated with accidental exposure to thiotepa may occur.
Croatian: Može doći do površinskih reakcija povezanih s izloženosti tiotepi.
English: DFS results confirm that conditioning treatment containing thiotepa following allogeneic HPCT are effective therapeutic strategies for treating paediatric patients with haematological diseases.
Croatian: Navedeni rezultati koji se odnose na DFS su potvrdili da je pripremni tretman s tiotepom nakon kojih slijedi alogena TKMS učinkovit izbor za liječenje pedijatrijskih bolesnika s hematološkim bolestima.
English: Decreased appetite Hyperglycaemia
Croatian: Anoreksija Smanjen apetit Hiperglikemija
English: - If you get any side effects, talk to your doctor.
Croatian: - Ako primjetite bilo koju nuspojavu, potrebno je obavijestiti liječnika.
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.
Croatian: 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.
English: Idiopathic pneumonia syndrome Pulmunary haemorrage Pulmonary oedema
Croatian: Sindrom idiopatske pneumonije Plućno krvarenje
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.
Croatian: 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.
English: Multi-organ failure Pain
Croatian: Višestruko otkazivanje organa Bol
English: Overall Survival: OS ranged from 30% to 87% with a follow-up ranging from 11.7 up to 87 months.
Croatian: 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.
English: After reconstitution, each ml contains 10 mg thiotepa (10 mg/ml).
Croatian: Nakon pripreme za primjenu, svaki ml sadrži 10 mg tiotepe (10 mg/ml).
English: BREAST CANCER
Croatian: RAK DOJKE
English: Venoocclusive liver disease
Croatian: Veno-okluzivna bolest jetre
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.
Croatian: 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.
English: You must tell your doctor if you are pregnant or you think you may be pregnant before you receive TEPADINA.
Croatian: 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.
English: TEPADINA is a white crystalline powder supplied in a glass vial containing 15 mg thiotepa.
Croatian: Kako TEPADINA izgleda i sadržaj pakiranja TEPADINA je bijeli kristalinični prašak u staklenoj bočici koja sadrži 15 mg tiotepe.
English: - The active substance is thiotepa.
Croatian: Što TEPADINA sadrži - Djelatna tvar je tiotepa.
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).
Croatian: 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).
English: LEUKAEMIA
Croatian: LEUKEMIJA
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.
Croatian: 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.
English: Overall Survival: OS ranged from 31% to 81% with a follow-up ranging from 7.3 up to 120 months.
Croatian: 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.
English: Back pain Myalgia Arthralgia
Croatian: Bol u leđima Mialgija Artralgija
English: TEPADINA is a white crystalline powder supplied in a glass vial containing 100 mg thiotepa.
Croatian: Kako TEPADINA izgleda i sadržaj pakiranja TEPADINA je bijeli kristalinični prašak u staklenoj bočici koja sadrži 100 mg tiotepe.
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.
Croatian: 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.
English: Daily white blood cell counts and platelet counts are recommended during therapy with thiotepa and after transplant for at least 30 days.
Croatian: Tijekom terapije sa tiotepom kao i do najmanje 30 dana poslije transplantacije se preporučuje svakodnevno određivanje broja leukocita i trombocita.
English: 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.
Croatian: 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.
English: CNS TUMOURS
Croatian: TUMORI CNS-a
English: Hypogonadism
Croatian: Hipogonadizam
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.
Croatian: 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.
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.
Croatian: 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.
English: 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.
Croatian: 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.
English: Studies in renally impaired patients have not been conducted.
Croatian: Nisu provedene studije kod bolesnika s oštećenjem funkcije bubrega.
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.
Croatian: 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.
English: Accord Healthcare Polska Sp. z o.o.
Croatian: Accord Healthcare B.V.
English: Solid tumours
Croatian: Solidni tumori
English: 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.
Croatian: U slučaju kliničke indikacije potrebne su transfuzije eritrocita i trombocita kao i primjena čimbenika rasta kao što je faktor stimulacije kolonije granulocita (G-CSF).
English: Linearity /non linearity There is no clear evidence of saturation of metabolic clearance mechanisms at high doses of thiotepa.
Croatian: Nema jasnog dokaza zasićenja mehanizama metaboličkog klirensa pri visokim dozama tiotepe.
English: Name and address of the manufacturer(s) responsible for batch release
Croatian: Naziv(i) i adresa(e) proizvođača odgovornog(ih) za puštanje serije lijeka u promet RIEMSER Pharma GmbH
English: Haemorrhage Embolism
Croatian: Hemoragijski cistitis
English: CSF and plasma concentrations of TEPA, the first reported active metabolite of thiotepa, exceed the concentrations of the parent compound.
Croatian: Koncentracije TEPA, glavnog aktivnog metabolita tiotepe, u likvoru i plazmi prelaze koncentracije same tiotepe.
English: Leukopenia Thrombocytopenia Febrile neutropenia Anaemia
Croatian: Febrilna neutropenija Anemija
English: Liver failure
Croatian: Zatajenje jetre
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.
Croatian: 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.
English: Frequency of administration
Croatian: Višestruko otkazivanje organa
English: If thiotepa accidentally contacts mucous membranes, they must be flushed thoroughly with water.
Croatian: Ako tiotepa slučajno dođe u dodir sa sluznicama, one se moraju temeljito isprati sa vodom.
English: One vial of powder contains 100 mg thiotepa.
Croatian: Jedna bočica praška sadrži 100 mg tiotepe.
English: How to use TEPADINA
Croatian: Kako primjenjivati lijek TEPADINA
English: One vial of powder contains 15 mg thiotepa.
Croatian: Jedna bočica praška sadrži 15 mg tiotepe.
English: Using a syringe fitted with a needle, aseptically withdraw 10 ml of sterile water for injections.
Croatian: Koristeći štrcaljku s pričvršćenom iglom, aseptički izvucite 10 ml vode za injekcije.
English: Using a syringe fitted with a needle, aseptically withdraw 1.5 ml of sterile water for injection.
Croatian: Koristeći štrcaljku s pričvršćenom iglom, aseptički izvucite 1,5 ml vode za injekcije.
English: Solutions containing a precipitate should be discarded.
Croatian: Otopine koje sadrže talog treba baciti.
English: Acute graft versus host disease Chronic graft versus host disease
Croatian: Akutna bolest transplantata protiv primatelja Kronična bolest transplantata protiv primatelja
English: Renal impairment The effects of renal impairment on thiotepa elimination have not been assessed.
Croatian: Učinci bubrežne disfunkcije na eliminaciju tiotepe nisu ocjenjivani.
English: After reconstitution with 1.5 ml of water for injections, each ml of solution contains 10 mg thiotepa (10 mg/ml).
Croatian: Nakon rekonstitucije s 1,5 ml vode za injekcije, svaki ml otopine sadrži 10 mg tiotepe (10 mg/ml).
English: Blood creatinine increased
Croatian: Povećanje kreatinina u krvi Povećanje ureje u krvi
English: 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.
Croatian: 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.
English: Ataxia
Croatian: Ataksija
English: After reconstitution with 10 ml of water for injections, each ml of solution contains 10 mg thiotepa (10 mg/ml).
Croatian: Nakon rekonstitucije s 10 ml vode za injekcije, svaki ml otopine sadrži 10 mg tiotepe (10 mg/ml).
English: One vial contains 15 mg thiotepa.
Croatian: Jedna bočica sadrži 15 mg tiotepe.
English: One vial contains 100 mg thiotepa.
Croatian: Jedna bočica sadrži 100 mg tiotepe.
English: It is likely that certain adverse reactions of thiotepa like dizziness, headache and blurred vision could affect these functions.
Croatian: Vjerojatno je da neke nuspojave tiotepe kao što su omglica, glavobolja i zamagljen vid mogu utjecati na navedene sposobnosti.