natgillin/translations-raw huggingface dataset:
Matblå og hvide kapsler påtrykt ”BMS 100 mg” på den ene halvdel og ”3623” på den anden halvdel med hvidt og blåt blæk.
Opaque blue and white capsule printed with white and blue inks, with "BMS 100 mg" on one half and with "3623" on the other half.
Hjerte:
SN:
Phenobarbital og phenytoin bør anvendes med forsigtighed sammen med
Phenobarbital and phenytoin should be used with caution in combination with REYATAZ/ritonavir.
REYATAZ 150 mg hårde kapsler fås i beholder med 60 kapsler.
REYATAZ 150 mg hard capsules are supplied in bottles of 60 capsules.
Tabel 9: Steady state farmakokinetik af atazanavir med ritonavir hos hiv-smittede gravide kvinder efter fødeindtagelse
Table 9: Steady-State Pharmacokinetics of Atazanavir with ritonavir in HIV-Infected Pregnant Women in the Fed State atazanavir 300 mg with ritonavir 100 mg Pharmacokinetic Parameter 2nd Trimester (n=9)
Blisterpakning: 30 hårde kapsler: EU/1/03/267/009
30 hard capsules: EU/1/03/267/009
Atazanavir, doseret 1 time efter ddI+d4T (fastende) Atazanavir AUC ↔3% (↓36% ↑67%) Atazanavir Cmax ↑12% (↓33% ↑18%) Atazanavir Cmin ↔3% (↓39% ↑73%)
Atazanavir AUC ↔3% (↓36% ↑67%) Atazanavir Cmax ↑12% (↓33% ↑18%) Atazanavir Cmin ↔3% (↓39% ↑73%)
Ritonavir en daglig dosisa
REYATAZ once daily dose ritonavir once daily dosea
Hver kapsel indeholder 200 mg atazanavir (som sulfat).
Each capsule contains 200 mg of atazanavir (as sulphate).
REYATAZ 200 mg hårde kapsler fås i beholder med 60 kapsler.
REYATAZ 200 mg hard capsules are supplied in bottles of 60 capsules.
REYATAZ 200 mg hårde kapsler atazanavir
REYATAZ 200 mg hard capsules atazanavir
1.441 celler/mm3 (interval: 84-5.703 celler/mm3), og middel-baseline-plasma hiv-1-RNA var 4,67 log10 kopier/ml (interval: 2,0-5,9 log10 kopier/ml).
(range: 84 to 5703 cells/mm 3) and mean baseline plasma HIV-1 RNA was 4.67 log10 copies/ml (range: 2.0 to 5.9 log10 copies/ml).
quetiapin (bruges til at behandle skizofreni, bipolar lidelse (manio-depressiv sygdom) og moderat til svær depresssion); lurasidon (bruges til behandling af skizofreni) medicin, der indeholder perikon (Hypericum perforatum, naturlægemiddel) triazolam og oralt (indtaget gennem munden) midazolam (bruges som sovemedicin eller til at behandle angst) simvastatin og lovastatin (bruges til at sænke mængden af kolesterol i blodet).
triazolam and oral (taken by mouth) midazolam (used to help you sleep and/or to relieve anxiety) simvastatin and lovastatin (used to lower blood cholesterol).
Hver kapsel indeholder 150 mg atazanavir (som sulfat).
Each capsule contains 150 mg of atazanavir (as sulphate).
REYATAZ 100 mg hårde kapsler fås i beholder med 60 kapsler.
REYATAZ 100 mg hard capsules are supplied in bottles of 60 capsules.
REYATAZ 100 mg hårde kapsler atazanavir
REYATAZ 100 mg hard capsules atazanavir
PDE5-hæmmere
ERECTILE DYSFUNCTION PDE5 Inhibitors
Samtidig administration af REYATAZ/ritonavir og præparater indeholdende perikon er kontraindiceret.
Co-administration of REYATAZ/ritonavir with products containing St. John's wort is contraindicated.
Hvert brev indeholder 50 mg atazanavir (som sulfat).
Each sachet contains 50 mg of atazanavir (as sulphate).
REYATAZ 300 mg hårde kapsler atazanavir
REYATAZ 300 mg hard capsules atazanavir
Matblå og dueblå kapsler påtrykt ”BMS 150 mg” på den ene halvdel og ”3624” på den anden halvdel med hvidt og blåt blæk.
Opaque blue and powder blue capsule printed with white and blue inks, with "BMS 150 mg" on one half and with "3624" on the other half.
HMG-CoA-reduktasehæmmere
ACID REDUCING AGENTS
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver kapsel indeholder 200 mg atazanavir (som sulfat).
STATEMENT OF ACTIVE SUBSTANCE(S) Each capsule contains 200 mg of atazanavir (as sulphate).
REYATAZ 100 mg hårde kapsler fås også som blisterkort pakket i æsker med 60 kapsler.
REYATAZ 100 mg hard capsules are also supplied in blister strips in packs of 60 capsules.
Hver kapsel indeholder 300 mg atazanavir (som sulfat).
Each capsule contains 300 mg of atazanavir (as sulphate).
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver kapsel indeholder 300 mg atazanavir (som sulfat).
STATEMENT OF ACTIVE SUBSTANCE(S) Each capsule contains 300 mg of atazanavir (as sulphate).
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver kapsel indeholder 150 mg atazanavir (som sulfat).
STATEMENT OF ACTIVE SUBSTANCE(S) Each capsule contains 150 mg of atazanavir (as sulphate).
Det anbefales at monitorere INR omhyggeligt under behandling med REYATAZ/ritonavir, særligt ved behandlingsstart.
REYATAZ/ritonavir, especially when commencing therapy.
For de behandlingsnaive pædiatriske patienter var middel baseline-CD4-celletal 344 celler/mm3 (interval 2-800 celler/mm3), og middel-baseline-plasma hiv-1RNA var 4,67 log10 kopier/ml (interval 3,70-5,00 log10 kopier/ml).
the mean baseline CD4 cell count was 344 cells/mm3 (range: 2 to 800 cells/ mm3) and mean baseline plasma HIV-1 RNA was 4.67 log10 copies/ml (range: 3.70 to 5.00 log10 copies/ml).
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hvert brev indeholder 50 mg atazanavir (som sulfat).
STATEMENT OF ACTIVE SUBSTANCE(S) Each sachet contains 50 mg of atazanavir (as sulphate).
Kapslens indhold: crospovidon, lactosemonohydrat og magnesiumstearat Kapslens skal: gelatine, rød jernoxid, sort jernoxid, gul jernoxid, indigocarmin (E132) og titandioxid (E171)
Capsule shells: gelatine, red iron oxide, black iron oxide, yellow iron oxide, indigocarmin (E132) and titanium dioxide (E171)
Hver kapsel indeholder 100 mg atazanavir (som sulfat).
Each capsule contains 100 mg of atazanavir (as sulphate).
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver kapsel indeholder 100 mg atazanavir (som sulfat).
STATEMENT OF ACTIVE SUBSTANCE(S) Each capsule contains 100 mg of atazanavir (as sulphate).
Autoimmune lidelser (såsom Graves sygdom og autoimmun hepatitis) er også rapporteret i forbindelse med immunreaktivering.
Autoimmune disorders (such as Graves' disease and autoimmune hepatitis) have also been reported to occur in the setting of immune reactivation; however, the reported time to onset is more variable and these events can occurs many months after initiation of treatment.
Ethinylestradiol Cmax ↓16% (↓26%
Ethinyloestradiol AUC ↓19% (↓25% Ethinyloestradiol Cmax ↓16% (↓26% Ethinyloestradiol Cmin ↓37% (↓45%
Spørg lægen, apotekspersonalet eller sundhedspersonalet, hvis du har spørgsmål vedrørende tilberedning eller indgivelse af en dosis REYATAZ oralt pulver.
If you have any questions on how to prepare or give a dose of REYATAZ oral powder, talk to your doctor, pharmacist or nurse.
Atazanavir AUC ↑43% (↑30% ↑57%) Atazanavir Cmax ↑12% (↑1% ↑24%) Atazanavir Cmin ↑23% (↑13% ↑134%)
Atazanavir AUC ↑43% (↑30% ↑57%) Atazanavir Cmax ↑12% (↑1% ↑24%) Atazanavir Cmin ↑23% (↑13% ↑134%) Grazoprevir AUC: ↑958% (↑678% Grazoprevir Cmax: ↑524% (↑342% Grazoprevir Cmin: ↑1064% (↑696%
Atazanavir AUC ↔2,3% (↓13%
Famotidine 40 mg twice daily Atazanavir AUC ↔2.3% (↓13%
Atazanavir AUC ↓18% (↓25% ↑1%) Atazanavir Cmax ↓20% (↓32% ↓7%) Atazanavir Cmin ↔1% (↓16% ↑18%)
Famotidine 20 mg twice daily Atazanavir AUC ↓18% (↓25% ↑1%) Atazanavir Cmax ↓20% (↓32% ↓7%)
Hver kapsel af REYATAZ 200 mg indeholder 200 mg atazanavir.
What REYATAZ looks like and contents of the pack Each capsule of REYATAZ 200 mg contains 200 mg atazanavir.
Samtidig administration af lægemidler, der er substrat for CYP3A4-isoformen af cytokrom P450 og har et snævert terapeutisk vindue (f.eks. quetiapin, lurasidon, alfuzosin, astemizol, terfenadin, cisaprid, pimozid, quinidin, bepridil, triazolam og midazolam administreret oralt (se pkt.
Co-administration with medicinal products that are substrates of the CYP3A4 isoform of cytochrome P450 and have narrow therapeutic windows (e.g., quetiapine, lurasidone, alfuzosin, astemizole, terfenadine, cisapride, pimozide, quinidine, bepridil, triazolam, midazolam administered orally (for caution on parenterally administered midazolam, see section 4.5), and ergot alkaloids, particularly, ergotamine, dihydroergotamine, ergonovine, methylergonovine) (see section 4.5).
Samtidig administration af lægemidler, der er substrat for CYP3A4-isoformen af cytokrom P450 og har et snævert terapeutisk vindue (f.eks. quetiapin, alfuzosin, astemizol, terfenadin, cisaprid, pimozid, quinidin, lurasidon, bepridil, triazolam og midazolam administreret oralt (se pkt.
Co-administration with medicinal products that are substrates of the CYP3A4 isoform of cytochrome P450 and have narrow therapeutic windows (e.g., quetiapine, alfuzosin, astemizole, terfenadine, cisapride, pimozide, quinidine, lurasidone, bepridil, triazolam, midazolam administered orally (for caution on parenterally administered midazolam, see section 4.5), and ergot alkaloids, particularly, ergotamine, dihydroergotamine, ergonovine, methylergonovine) (see section 4.5).
Kan være skadeligt for patienter med fenylketonuri.
Aspartame provides a source of phenylalanine and, therefore, may not be suitable for persons with phenylketonuria.
a Gennemsnitligt CD4-celletal ved baseline var 214 celler/mm3 (i området 2 til 810 celler/mm3) og gennemsnitligt plasma hiv-1-RNA ved baseline var 4,94 log10 kopier/ml (i området 2,6 til 5,88 log10 kopier/ml) b REYATAZ/RTV med tenofovirdisoproxilfumarat/emtricitabin (fast dosis på 300 mg/200 mg tabletter én gang dagligt).
a Mean baseline CD4 cell count was 214 cells/mm3 (range 2 to 810 cells/mm3) and mean baseline plasma HIV-1 RNA was 4.94 log10 copies/ml (range 2.6 to 5.88 log10 copies/ml)
Med tenofovirdisoproxilfumarat 300 mg 1 gang dagligt (ækvivalent med 245 mg tenofovirdisoproxil)
With Tenofovir disoproxil fumarate 300 mg once daily (equivalent to 245 mg tenofovir disoproxil) In HIV-infected patients with atazanavir/ritonavir at the recommended dose of 300/100 mg once daily
Blisterpakning: 60 hårde kapsler: EU/1/03/267/004
60 hard capsules: EU/1/03/267/004
Blisterpakning: 60 hårde kapsler: EU/1/03/267/006
60 hard capsules: EU/1/03/267/006
Sofosbuvir AUC: ↑40% (↑25% ↑57%) Sofosbuvir Cmax: ↑29% (↑9% ↑52%)
Sofosbuvir AUC : ↑40% (↑25% ↑57%) Sofosbuvir Cmax :↑29% (↑9% ↑52%) Velpatasvir AUC: ↑93% (↑58% Velpatasvir Cmax : ↑29% (↑7% ↑56%) Voxilaprevir AUC : ↑331% (↑276% Voxilaprevir Cmax : ↑342% (↑265%
BETA-AGONISTER TIL INHALATION
LIPID LOWERING AGENTS HMG-CoA reductase inhibitors
Omeprazol 40 mg 1 gang dagligt (atazanavir 400 mg 1 gang dagligt med ritonavir 100 mg 1 gang dagligt)
Proton pump inhibitors Omeprazole 40 mg once daily (atazanavir 400 mg once daily with ritonavir 100 mg once daily)
Hver kapsel af REYATAZ 150 mg indeholder 150 mg atazanavir.
What REYATAZ looks like and contents of the pack Each capsule of REYATAZ 150 mg contains 150 mg atazanavir.
Hvis kombination af REYATAZ/ritonavir sammen med en protonpumpehæmmer vurderes at være nødvendig, anbefales omhyggelig monitorering og dosisøgning af REYATAZ til 400 mg med 100 mg ritonavir.
REYATAZ/ritonavir with a proton pump inhibitor is judged unavoidable, close clinical monitoring is recommended in combination with an increase in the dose of REYATAZ to 400 mg with 100 mg of ritonavir; doses of proton pump inhibitors comparable to omeprazole 20 mg should not be exceeded (see section 4.4).
REYATAZ/ritonavir anbefales ikke (se pkt.
Co-administration of salmeterol with REYATAZ/ritonavir is not recommended (see section 4.4).
Denne indlægsseddel blev senest ændret MM/ÅÅÅÅ
This leaflet was last revised in
Beholderpakning: 60 hårde kapsler: EU/1/03/267/003
60 hard capsules: EU/1/03/267/003
Hvis kombination vurderes at være nødvendig, anbefales omhyggelig monitorering og dosisøgning af REYATAZ til 400 mg med 100 mg ritonavir.
If the combination is judged unavoidable, close clinical monitoring is recommended in combination with an increase in the dose of REYATAZ to 400 mg with 100 mg of ritonavir; doses of proton pump inhibitors comparable to omeprazole 20 mg should not be exceeded (see section 4.4).
Blisterpakning: 60 hårde kapsler: EU/1/03/267/002
60 hard capsules: EU/1/03/267/002
Rifabutin Cmin ↑40% (↑5% ↑87%) **
Atazanavir Cmin ↓19% (↓37% ↑5%) *
REYATAZ/ritonavir.
No dose adjustment is needed for REYATAZ/ritonavir.
Lægen vil drøfte denne risiko med dig.
Your doctor will discuss this risk with you.
Visse tilfælde havde dødeligt udfald.
Some cases had a fatal outcome.
Behandlingen kan vare op til 5 dage.
The duration of treatment can last up to 5 days.
Uåbnet hætteglas 18 måneder.
Unopened vial 18 months.
Virkningen af succinylcholin kan forlænges med 5-15 minutter.
The action of succinyl-choline can be prolonged by 5 to 15 minutes.
Nedenstående oplysninger er til sundhedspersonale.
The following information is intended for healthcare professionals only.
Dato for første markedsføringstilladelse:15. marts 2010 Dato for seneste fornyelse: 15. marts 2015
Date of first authorisation: 15 March 2010 Date of latest renewal: 15 March 2015
Der skal i stedet bruges en inaktiveret virusvaccine, når det er muligt (poliomyelitis).
An inactivated virus vaccine should be used instead, whenever possible (poliomyelitis).
Filtrering ændrer ikke opløsningens styrke.
Filtering does not alter solution potency.
Disse virkninger blev konstateret ved doser, der var lavere end de doser, der bruges til mennesker.
These effects were seen at doses lower than those used in humans.
Dosisjustering blev ikke skønnet nødvendig.
No dose adjustment was deemed necessary.
- TEPADINA indeholder ikke andre ingredienser.
- TEPADINA does not contain any other ingredients.
Hver infusion tager 2-4 timer.
Each infusion will last 2-4 hours.
Kun farveløse opløsninger uden partikler må anvendes.
Only colourless solutions, without any particulate matter, must be used.
Hyppigheden af doseringerne og varigheden af behandlingen afhænger af din sygdom.
Frequency of administration and duration of treatment depend on your disease.
Lægen fastlægger din dosis ud fra din kropsoverflade eller -vægt og din sygdom.
Your doctor will calculate the dose according to your body surface or weight and your disease.
Bivirkninger ved TEPADINA kan forekomme med bestemte hyppigheder, som er defineret på følgende måde:
Side effects of TEPADINA may occur with certain frequencies, which are defined as follows:
TEPADINA kan forårsage en anden kræfttype i fremtiden.
TEPADINA may cause another type of cancer in the future.
Eliminationshalveringstiden varierede fra 1,5 til 4,1 timer.
The elimination half-life varied from 1.5 to 4.1 hours.
Hæmatologisk restitution forekommer inden for den forventede tid.
The haematological recovery is in the expected time.
Fra et mikrobiologisk synspunkt bør lægemidlet anvendes øjeblikkeligt.
From a microbiological point of view, the product should be used immediately.
Specifik interaktion med thiotepa
Specific interactions with thiotepa
Kravene for fremsendelse af periodiske, opdaterede sikkerhedsindberetninger for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF, og alle efterfølgende opdateringer offentliggjort på den europæiske webportal for lægemidler.
The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Thiotepa er derfor kontraindiceret under graviditet.
Therefore, thiotepa is contraindicated during pregnancy.
Resultaterne af offentliggjorte kliniske undersøgelser, der støtter effekten af thiotepa, er sammenfattet i det følgende:
The results of published clinical studies supporting the efficacy of thiotepa are summarised:
Den øgede risiko for sekundær malignitet i forbindelse med thiotepa, et kendt carcinogen for mennesker, skal forklares for patienten.
The increased risk of a secondary malignancy with thiotepa, a known carcinogen in humans, must be explained to the patient.
I kliniske undersøgelser modtog en andel af patienterne på 65 år og derover den samme kumulerede dosis som de øvrige patienter.
However, in clinical studies, a proportion of patients over the age of 65 received the same cumulative dose as the other patients.
Urinudskillelse af thiotepa og TEPA er næsten fuldstændig efter henholdsvis seks og otte timer.
Urinary excretion of thiotepa and TEPA is nearly complete after 6 and 8 hours respectively.
Fortæl det til lægen, hvis du er gravid, eller hvis du tror, at du kan være gravid, inden du modtager TEPADINA.
You must tell your doctor if you are pregnant or you think you may be pregnant before you receive TEPADINA.
Fjern sprøjten og kanylen, og bland manuelt ved gentagne inversioner.
Remove the syringe and the needle and mix manually by repeated inversions.
GvHD (graft versus host-sygdom): Alle de vurderede konditioneringer sikrede en lav forekomst af akut GvHD klasse III-IV (fra 4 % til 24 %).
GvHD (graft versus host disease): all conditioning treatments evaluated assured a low incidence of acute GvHD grade III-IV (from 4% to 24%).
TEPADINA kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
Like all medicines, TEPADINA can cause side effects, although not everybody gets them.
Tidligere hjernebestråling eller kraniospinal bestråling kan bidrage til svære toksiske reaktioner (f.eks. encefalopati).
Previous brain irradiation or craniospinal irradiation may contribute to severe toxic reactions (e.g. encephalopathy).
Delirium Nervøsitet Hallucination Agitation
Delirium Nervousness Hallucination Agitation
Thiotepas sikkerhed er blevet undersøgt ved en gennemgang af bivirkninger rapporteret i publicerede data fra kliniske studier.
The safety of thiotepa has been examined through a review of adverse events reported in published data from clinical trials.
Da TEPADINA ødelægger knoglemarvsceller, som er ansvarlige for at producere blodceller, bliver der taget regelmæssige blodprøver under behandlingen for at kontrollere dine blodlegemer.
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.
I disse studier har i alt 6.588 voksne og 902 børn fået thiotepa som konditionerende behandling før hæmatopoietisk stamcelletransplantation.
In these studies, a total of 6,588 adult patients and 902 paediatric patients received thiotepa for conditioning treatment prior to haematopoietic progenitor cell transplantation.
Samtidig brug tilrådes ikke
Concomitant use not recommended
Farmakoterapeutisk klassifikation: antineoplastiske midler, alkylerende midler , ATC-kode: L01AC01
Pharmacotherapeutic group: Antineoplastic agents, Alkylating Agents, ATC code: L01AC01
Du modtager dine infusioner med 12 eller 24 timers mellemrum.
You will receive your infusions every 12 or 24 hours.
Det er ukendt, om thiotepa udskilles i human mælk.
It is unknown whether thiotepa is excreted in human milk.
Alle overførselsprocedurer kræver streng overholdelse af aseptiske teknikker, og der bør anvendes sikkerhedsskærm med vertikalt laminarflow.
All transfer procedures require strict adherence to aseptic techniques, preferably employing a vertical laminar flow safety hood.
Konditioneringen skal sikre cytoreduktion og ideelt sygdomsudryddelse.
The conditioning treatment must provide cytoreduction and ideally disease eradication.
Ved behandling af sådanne patienter anbefales det, at serumtransaminase, alkalisk fosfatase og bilirubin regelmæssigt monitoreres efter transplantation med henblik på tidlig påvisning af hepatoksicitet.
When treating such patients it is recommended that serum transaminase, alkaline phosphatase and bilirubin are monitored regularly following transplant, for early detection of hepatotoxicity.
Der foreligger ingen data om anvendelse af thiotepa under graviditet.
There are no data on the use of thiotepa during pregnancy.
Metabolitterne er aktive alkylerende stoffer, men den rolle, de spiller for thiotepas antitumor-aktivitet, skal stadig belyses.
The metabolites are active alkylating agents but the role they play in the antitumor activity of thiotepa remains to be elucidated.
Middelværdien for urinrestitution for thiotepa og dets metabolitter er 0,5 % for det uændrede lægemiddel og monokloro-tepa og 11 % for TEPA og thiotepa-merkapturat.
The mean urinary recovery of thiotepa and its metabolites is 0.5% for the unchanged medicinal product and monochlorotepa, and 11% for TEPA and thiotepa-mercapturate.
Som en sikkerhedsforanstaltning må kvinder ikke amme under behandling med TEPADINA.
As a precautionary measure, women must not breast-feed during treatment with TEPADINA.
Der er ikke gennemført konventionelle undersøgelser af toksicitet efter akutte og gentagne doser.
No conventional acute and repeat dose toxicity studies were performed.
Thiotepa må ikke indgives samtidig med cyklofosfamid, når begge lægemidler er til stede i samme konditionering.
Thiotepa must not be concurrently administered with cyclophosphamide when both medicinal products are present in the same conditioning treatment.
Det umiddelbare fordelingsvolumen for thiotepa er tilsyneladende uafhængigt af den indgivne dosis.
The apparent volume of distribution of thiotepa appears independent of the administered dose.
Daglig tælling af hvide blodlegemer og trombocyttal anbefales under behandling med thiotepa og efter transplantation i mindst 30 dage.
Daily white blood cell counts and platelet counts are recommended during therapy with thiotepa and after transplant for at least 30 days.
Det vides ikke, om denne medicin udskilles i modermælk.
It is not known whether this medicinal product is excreted in breast milk.
Levende svækkede vacciner (med undtagelse af gul feber): risiko for systemisk, muligvis dødelig sygdom.
Live attenuated vaccines (except yellow fever): risk of systemic, possibly fatal disease.
Øget følsomhed for infektioner Sepsis
Infection susceptibility increased Sepsis
Der skal foretages hyppige komplette blodtællinger, herunder differential tælling af hvide blodlegemer, samt trombocyttællinger under behandlingen, og indtil restituering opnås.
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.
Samtidig brug skal overvejes Ciclosporin, tacrolimus: overdreven immunsuppression med risiko for lymfoproliferation.
Concomitant use to take into consideration Ciclosporine, tacrolimus: excessive immunosuppression with risk of lymphoproliferation.
Der skal anvendes procedurer for korrekt håndtering og destruktion af anticancer-lægemidler.
Procedures for proper handling and disposal of anticancer medicinal products must be considered.
TEPADINA er indiceret i kombination med andre kemoterapeutika:
TEPADINA is indicated, in combination with other chemotherapy medicinal products:
I nogle tilfælde er der rapporteret tilbagefaldsprocenter på 35 % og 45 % efter henholdsvis fem og seks år.
In some cases, relapse rates of 35% and of 45% have been reported at 5 years and 6 years respectively.
Dosisjustering anbefales ikke ved forbigående ændringer af leverparametre (se pkt.
Dose modification is not recommended for transient alterations of hepatic parameters (see section 4.4).
Thiotepa gennemgår hurtig og omfattende levermetabolisme, og metabolitter kan registreres i urinen inden for en time efter infusion.
Thiotepa undergoes rapid and extensive hepatic metabolism and metabolites could be detected in urine within 1 hour after infusion.
Disse metabolitter findes ikke i urin og udskilles, hvis de dannes, sandsynligvis via galden eller som intermediære metabolitter, der hurtigt omdannes til thiotepa-merkapturat.
These metabolites are not found in urine, and, if formed, are probably excreted in bile or as intermediate metabolites rapidly converted into thiotepa-mercapturate.
Infusionsopløsningen skal indgives til patienter ved hjælp af et infusionssæt, der er forsynet med et 0,2 µm integreret filter.
The infusion solution must be administered to patients using an infusion set equipped with a 0.2 µm in-line filter.