natgillin/translations-raw huggingface dataset:
Mere alvorlige reaktioner kan forekomme.
More severe reactions may occur.
En opdateret RMP skal indsendes senest den 31 oktober 2019.
An updated RMP shall be submitted by 31 October 2019.
• hvis antallet af hvide blodlegemer er for lavt,
• if the number of white blood cells is too low.
Dato for første tilladelse: 27. november 1995 Dato for seneste fornyelse: 27. november 2005
Date of first authorisation: 27 November 1995 Date of latest renewal: 27 November 2005
Tumorstørrelse 2 cm >2 cm
Tumour size 2 cm >2 cm
a fra GETUG AFU15 studiet
a From the GETUG AFU15 study
Resume af sikkerhedsprofilen for alle indikationer
Summary of the safety profile for all indications
Hver blisterpakning indeholder:
Each blister pack contains:
• Hårtab: I de fleste tilfælde vil normal hårvækst vende tilbage.
• hair loss: in most cases normal hair growth should return.
a Tid til hændelsesvariabler: stratificeret log-rank test.
a Time to event variables: Stratified log-rank test.
Dosis vil afhænge af din vægt og din almene tilstand.
The dose will depend on your weight and your general condition.
Ingen af disse frekevensstigninger nåede en 10 % forskel med kontrolarmen.
None of these increases in frequency reached 10% difference with the control arm.
TAXOTERE indeholder alkohol.
TAXOTERE contains alcohol.
TAXOTERE vil blive administreret af personale med en sundhedsfaglig uddannelse.
TAXOTERE will be administered to you by a healthcare professional.
Der bør anvendes effektiv kontraception under behandlingen.
An effective method of contraception should be used during treatment.
Anden episode: Afbryd behandlingen
Second episode: discontinue treatment.
Dette er fordi TAXOTERE eller den anden medicin måske ikke virker så godt som forventet, og du måske lettere får bivirkninger.
This is because TAXOTERE or the other medicine may not work as well as expected and you may be more likely to get a side effect.
Spørg din læge til råds, før du tager nogen form for medicin.
Ask your doctor for advice before being given any medicine.
• 2 år.
• 2 years.
Opfylder relativ indikation for kemoterapi a
Meeting relative indication for chemotherapy a
TAXOTERE koncentrat
TAXOTERE concentrate
• Stigning i blodsukkerniveauet (diabetes)
• rises in blood sugar levels (diabetes)
Tilfældene var spontant reversible inden for 3
The events were spontaneously reversible within 3 months.
Hvis det ikke anvendes straks, er opbevaringstid og -forhold brugerens ansvar.
If not used immediately, in-use storage times and conditions are the responsibility of the user.
Hvis patienten fortsætter med at få disse reaktioner ved 60 mg/m bør behandlingen stoppes.
If the patient continues to experience these reactions at 60 mg/m², the treatment should be discontinued.
• 3 år.
• 3 years.
I alt blev 790 mandlige patienter tildelt til de 2 behandlingsgrupper.
A total of 790 male patients were allocated to the 2 treatment groups.
TAXOTEREs sikkerhed og virkning ved nasofaryngealt karcinom hos børn i alderen 1 måned til under 18 år er endnu ikke klarlagt.
The safety and efficacy of TAXOTERE in nasopharyngeal carcinoma in children aged 1 month to less than 18 years have not yet been established.
Tilfælde af permanent alopeci (hyppighed ikke kendt) er rapporteret.
Cases of permanent alopecia (frequency not known) have been reported.
I alt 1006 patienter med KPS  60 blev randomiseret i følgende behandlingsgrupper:
A total of 1006 patients with KPS  60 were randomised to the following treatment groups:
Tid til klinisk progressionc
Time to clinical progressionc
STAMPEDE studie
STAMPEDE study
Du må ikke amme, mens du behandles med TAXOTERE.
You must not breast-feed while you are treated with TAXOTERE.
Solvensen er en farveløs opløsning.
The solvent is a colourless solution.
For docetaxel /Carboplatin-kombinationen kunne der hverken bevises ekvivalent eller non-inferior effekt sammenlignet med referencebehandlingen kombination VCis.
For docetaxel/carboplatin combination, neither equivalent nor non-inferior efficacy could be proven compared to the reference treatment combination VCis.
Kirurgisk indgreb på det primære sygdomssted og/eller hals kunne overvejes når som helst efter endt CRT.
Surgery on the primary site of disease and/or neck could be considered at any time following completion of CRT.
Din læge kan ændre dosis og dosisfrekvensen afhængig af dine blodprøver, din almene helbredstilstand og din reaktion på TAXOTERE.
Your doctor may change the dose and frequency of dosing depending on your blood tests, your general condition and your response to TAXOTERE.
Patienter skal informeres om tegn og symptomer for alvorlige hud manifestationer og monitoreres tæt.
Patients should be informed about the signs and symptoms of serious skin manifestations and closely monitored.
Infusionen tager ca. en time, hvor du skal være på hospitalet.
The infusion will last approximately one hour during which you will be in the hospital.
Hvis der forekommer krystaller, må opløsningen ikke længere anvendes og den skal kasseres.
If crystals appear, the solution must no longer be used and shall be discarded.
• Standardpleje alene
• Standard of care alone
Informer din læge eller hospitalsfarmaceut, hvis du tager eller for nylig har taget nogen anden form for medicin, herunder også medicin, som ikke er på recept.
Please tell your doctor or hospital pharmacist if you are taking or have recently taken any other medicine, including medicines obtained without a prescription.
I kombination med trastuzumab, vises de bivirkninger (alle grader), som er rapporteret hos  10 %.
For combination with trastuzumab, adverse events (all grades) reported in ≥ 10% are displayed.
Behandlingscyklus var på 3 uger for TCF-armen og 4 uger for CF-armen.
The length of a treatment cycle was 3 weeks for the TCF arm and 4 weeks for the CF arm.
CHAARTED studie
CHAARTED study
INFORMATION I BRAILLE SKRIFT
INFORMATION IN BRAILLE
Præmixen skal bruges straks efter tilberedning.
The premix solution should be used immediately after preparation.
Data for DFS var ikke statistisk signifikante men blev alligevel forbundet med en positiv tendens til fordel for TAC.
DFS data were not statistically significant but were still associated with a positive trend in favour of TAC.
• Forhøjede leverenzymer (derfor behovet for regelmæssige blodprøver)
• raised liver enzymes (hence the need for regular blood tests)
ER/PR-negativ eller grad 3 eller tumorstørrelse >5 cm
ER/PR-negative or Grade 3 or tumour size >5 cm
Din læge vil beregne din legemsoverflade i m og bestemme den dosis, du skal have.
Your doctor will calculate your body surface area in square meters (m²) and will determine the dose you should receive.
Akut leukæmi / myelodysplastisk syndrom
Acute leukaemia / Myelodysplastic syndrome.
Det skal du vide, før du begynder at bruge TAXOTERE
What you need to know before you use TAXOTERE
Hyppigheder defineres som: meget almindelig ( 1/10); almindelig ( 1/100 til < 1/10); ikke almindelig ( 1/1000 til < 1/100); sjælden ( 1/10.000 til < 1/1000); meget sjælden (< 1/10.000); hyppighed ikke kendt (kan ikke estimeres ud fra tilgængelige data).
Frequencies are defined as: very common (≥ 1/10), common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from available data).
Se den medfølgende vejledning.
See accompanying preparation guide.
Dette var også statistisk signifikant med en HR på 0,71; 95 % CI 0,56-0,90; log-rank test p = 0,004.
This was also statistically significant with an HR of 0.71; 95% CI 0.56-0.90; log-rank test p = 0.004.
Før hver behandling med TAXOTERE, vil du få taget blodprøver for at få kontrolleret, om du har nok blodceller og den nødvendige leverfunktion til at få TAXOTERE.
Before each treatment with TAXOTERE, you will have blood tests to check that you have enough blood cells and sufficient liver function to receive TAXOTERE.
Hvis du har yderligere spørgsmål om anvendelsen af dette lægemiddel, så spørg din læge eller hospitalsfarmaceut.
If you have any further questions on the use of this medicine, ask your doctor, or hospital pharmacist.
Neutropenisk infektion
Neutropenic infection
(539 patienter i
(521 patients in
• Periodiske, opdaterede sikkerhedsindberetninger (PSUR'er) Indehaveren af markedsføringstilladelsen skal fremsende PSUR'er for dette lægemiddel i overensstemmelse med kravene på listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF og offentliggjort på den europæiske webportal for lægemidler.
The marketing authorisation holder shall submit PSUR for this product in accordance with the requirements 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.
Stratificeret log rank test *Tærskel for statististiskl signifikans =0,0175 **PSA: Prostata-Specific Antigen
Stratified log-rank test *Threshold for statistical significance = 0.0175 **PSA: Prostate-Specific Antigen
Medicinen hedder TAXOTERE.
The name of this medicine is TAXOTERE.
Uåbnede hætteglas 2 år
Unopened vial 2 years
Den anden interim-analyse blev udført efter optagelse af ialt 400 DFS hændelser, hvilket førte til en median-opfølgning ved 55 måneder.
The second interim analysis was done after 400 DFS events had been recorded overall, which led to a median follow-up of 55 months.
Blandt de 1776 randomiserede patienter, havde 1086 (61 %), metastatisk sygdom, 362 var randomiseret til docetaxel i kombination med standardpleje, 724 modtog standardpleje alene.
Among the 1776 randomised patients 1086 (61%) had metastatic disease, 362 were randomised to docetaxel in combination with standard of care, 724 received standard of care alone.
• hvis du har en alvorlig leverlidelse.
• if you have a severe liver disease.
Anvend lægemidlet umiddelbart efter tilsætning til infusionsposen.
Use immediately the medicine once added into the infusion bag.
Der er gennemført et studie med
A study of
ENTYDIG IDENTIFIKATOR - 2D-STREGKODE
UNIQUE IDENTIFIER - 2D BARCODE Not applicable
Det er påvist, at docetaxel er både embryo-og føtotoksisk hos kaniner og rotter, samt at de nedsætter fertiliteten hos rotter.
Docetaxel has been shown to be both embryotoxic and foetotoxic in rabbits and rats, and to reduce fertility in rats.
Du må ikke blive gravid under behandling med dette lægemiddel, og du skal bruge effektiv prævention under behandlingen, fordi TAXOTERE kan skade det ufødte barn.
You must not become pregnant during treatment with this medicine and must use an effective method of contraception during therapy , because TAXOTERE may be harmful for the unborn baby.
A. FREMSTILLERE ANSVARLIG(E) FOR BATCHFRIGIVELSE
A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
• hvis du er allergisk (overfølsom) overfor docetaxel eller nogle af de andre indholdsstoffer i
• if you are allergic (hypersensitive) to docetaxel or any of the other ingredients of TAXOTERE
Progressiv sygdom som bedste overlevelse respons (%) *Ustratificerede logrank test
Progressive disease as best overall Response (%) *Unstratified logrank test
Reversibilitets-data tilgængelige hos 35,3 % af de patienter, som udviklede neurotoksicitet efter docetaxel-behandling med 100 mg/m som enkelt stof.
Reversibility data are available among 35.3% of patients who developed neurotoxicity following docetaxel treatment at 100 mg/m² as single agent.
SOLVENS til TAXOTERE
SOLVENT for TAXOTERE
TAXOTERE indeholder ethanol (alkohol)
TAXOTERE contains ethanol (alcohol)
• Reduktion af kalium, calcium og/eller fosfat i dit blod.
• decrease of the potassium, calcium and/or phosphate in your blood.
Docetaxels kinetiske profil er dosis-uafhængig og i overensstemmelse med en 3compartment farmakokinetisk model, med halveringstider for ,  og  faserne på henholdsvis 4 min., 36 min. og 11,1 time.
The kinetic profile of docetaxel is dose independent and consistent with a three-compartment pharmacokinetic model with half-lives for the ,  and  phases of 4 min, 36 min and 11.1 h, respectively.
Patienter, der tidligere har fået behandling med kemoterapi med eller uden strålebehandling
Patients previously treated with chemotherapy with or without radiotherapy
Ældre patienter, som behandles med TCF, bør monitores nøje.
Older people treated with TCF should be closely monitored.
LVEF-nedsættelse > 20 % (13,1 % versus 6,1 %), total LVEF-nedsættelse > 30 % (6,2 % versus 1,1 %).
decrease  20% (13.1% versus 6.1%), absolute LVEF decrease  30% (6.2% versus 1.1%).
Der er rapporter om sjælden forekomst af dehydrering som en konsekvens af gastrointestinale lidelser, herunder enterocolitis og gastrointestinal perforation.
Rare occurrences of dehydration have been reported as a consequence of gastrointestinal events including enterocolitis and gastrointestinal perforation.
Febril neutropeni og neutropenisk infektion forekom hos respektivt 17,2 % og 13,5 % af patienterne, uanset anvendelse af G-CSF.
Febrile neutropenia and neutropenic infection occurred in 17.2% and 13.5% of patients respectively, regardless of G-CSF use.
De mest almindeligt rapporterede bivirkninger med docetaxel var: Neutropeni (som var reversibel og ikke kumulativ, median-dagen til nadir var 7 dage og median-varigheden af alvorlig neutropeni ( 500 celler/mm
The most commonly reported adverse reactions of docetaxel alone are: neutropenia (which was reversible and not cumulative; the median day to nadir was 7 days and the median duration of severe neutropenia (< 500 cells/mm
Hvis der synes tegn og symptomer, der tyder på disse reaktioner, bør seponering af docetaxel overvejes.
If signs and symptoms suggestive of these reactions appear discontinuation of docetaxel should be considered.
Blod og lymfesystem Sjældent: Blødningsepisoder associeret med grad 3/4 trombocytopeni.
Blood and lymphatic system disorders Rare: bleeding episodes associated with grade 3/4 thrombocytopenia.
Patienter med operabel, lymfeknude-positiv brystkræft (TAX 316)
Patients with operable node-positive breast cancer (TAX 316)
Docetaxel hører til gruppen af kræftmedicin, der kaldes taxaner.
Docetaxel belongs to the group of anti-cancer medicines called taxoids.
Responsrate i alt (CR+PR) (%) p-værdi
Overall response rate (CR+PR) (%) p-value
Oesophagitis (alvorlig:
Oesophagitis (severe:
TAXOTERE må IKKE anvendes, hvis du er gravid eller planlægger at blive gravid, medmindre din læge udtrykkelig ønsker det.
TAXOTERE must NOT be administered if you are pregnant unless clearly indicated by your doctor.
Vaskulære sygdomme Venøse tromboemboliske tilfælde er sjældent rapporteret.
Vascular disorders Venous thromboembolic events have rarely been reported.
Den sædvanlige dosis er
Usual dose
Alvorligheden af bivirkningerne ved TAXOTERE kan forøges, når TAXOTERE gives i kombination med andre kemoterapeutiske lægemidler.
The severity of adverse events of TAXOTERE may be increased when TAXOTERE is given in combination with other chemotherapeutic agents.
Febril neutropeni og neutropenisk infektion forekom respektivt hos 12,1 % og 3,4 % af patienterne, når patienterne modtog profylaktisk G-CSF, hos 15,6 % og 12,9 % af patienterne uden profylaktisk G-CSF (se punkt 4.2).
Febrile neutropenia and neutropenic infection occurred respectively in 12.1% and 3.4% of patients when patients received prophylactic G-CSF, in 15.6% and 12.9% of patients without prophylactic G-CSF (see section 4.2).
TAXOTERE gives som infusion i en vene (intravenøs anvendelse).
TAXOTERE will be given by infusion into one of your veins (intravenous use).
Sanofi-Aventis Deutschland GmbH Industriepark Höchst 65926 Frankfurt am Main Tyskland
Sanofi-Aventis Deutschland GmbH Industriepark Höchst 65926 Frankfurt am Main Germany
I ca 20% af tilfældene var der ingen risikofaktorer for akut nyresvigt såsom samtidig behandling med nefrotoksiske lægemidler og gastrointestinale sygdomme.
In about 20% of these cases there were no risk factors for acute renal failure such as concomitant nephrotoxic medicinal products and gastrointestinal disorders.
Uden primær G-CSFprofylakse (n = 111) n (%)
Without primary G-CSF prophylaxis (n = 111) n (%)
Baseret på de farmakokinetiske studier findes der ingen særlige retningslinjer for ældre personer.
Based on a population pharmacokinetic analysis, there are no special instructions for use in older people.
Der blev udført eksplorativ undergruppeanalyse af sygdoms-fri overlevelse for patienter, der opfylder kriterierne for kemoterapi ifølge 2009 St. Gallen-kriterierne - (ITT population).
Exploratory subgroup analyses for disease-free survival for patients who meet the 2009 St. Gallen chemotherapy criteria - (ITT population) were performed and presented here below:
Anbefaling for sikker håndtering
Recommendations for the safe handling
Overfølsomhedsreaktioner forårsaget af det aktive stof eller et af hjælpestofferne anført i pkt 6.1.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Dyspnø (alvorlig:
Dyspnoea (severe:
Anvend hætteglasset umiddelbart efter åbning.
Use the vial immediately after its opening.
TAXOTERE leveres som enkeltdosis hætteglas.
TAXOTERE is supplied as single-dose vials.
Enkelt dosis hætteglas - kasser ubrugt indhold på passende måde.
Single-use vials - discard unused contents appropriately.
Farmakoterapeutisk klassifikation : Taxaner, ATC kode: L01CD 02
Pharmacotherapeutic group: Taxanes, ATC Code: L01CD 02
TAXOTERE hætteglas skal opbevares mellem +2ºC - +25ºC og beskyttes mod lys.
TAXOTERE vials should be stored between 2°C and 25°C and protected from light.
De patienter, der fik docetaxel hver 3. uge, viste signifikant længere total overlevelse sammenlignet med dem, der fik mitoxantron.
Patients who received docetaxel every three weeks demonstrated significantly longer overall survival compared to those treated with mitoxantrone.
C-mærket docetaxel på 3 kræftpatienter.
C-docetaxel has been conducted in three cancer patients.
For flere detaljer se produktresumé for trastuzumab.
For more details see summary of product characteristics of trastuzumab.
Myalgi (alvorlig: 1,4 %) Artralgi
Myalgia (severe: 1.4%) Arthralgia
I docetaxel - plus trastuzumabarmen, havde 64 % modtaget en tidligere behandling med antracyclin som adjuverende behandling sammenlignet med 55 % i docetaxel-armen alene.
In the docetaxel plus trastuzumab arm, 64% had received a prior anthracycline as adjuvant therapy compared with 55% in the docetaxel arm alone.
1 hætteglas solvens til TAXOTERE
1 vial of solvent for TAXOTERE
Farmakoterapeutisk klassifikation : Taxaner, ATC kode: L01CD02
Pharmacotherapeutic group: Taxanes, ATC Code: L01CD02
Sanofi Mature IP, 54 rue La Boétie, 75008 Paris, Frankrig
Sanofi Mature IP, 54 rue La Boétie, 75008 Paris, France
Hver karton indeholder et hætteglas.
Each box contains one vial.
2 ml (påfyldt 2,36 ml)
2 ml (Fill 2.36 ml)
Hvis der opstår alvorlig neutropeni (< 500 celler/mm3) i mere end 7 dage i løbet af en docetaxelbehandling, anbefales det at reducere dosis i de efterfølgende cyklusser eller at tage passende symptomatiske forholdsregler (se pkt.
In the case of severe neutropenia (< 500 cells/mm for seven days or more) during a course of docetaxel therapy, a reduction in dose for subsequent courses of therapy or the use of appropriate symptomatic measures are recommended (see section 4.2).
Flere patienter i alderen ≥ 65 år, i docetaxel-armen, rapportede overfølsomhedsreaktioner, neutropeni, anæmi, væskeretention, dyspnø, og negleforandringer, når sammenlignet med patienter i alderen yngre end 65 år.
More patients aged ≥65 years in the docetaxel arm reported hypersensitivity reaction, neutropenia, anaemia, fluid retention, dyspnea, and nail changes when compared to the patients aged less than 65 years.
TTP-medianen var 37,3 uger (95 %CI: 33,4 - 42,1) i AT-armen og 31,9 uger (95 %CI: 27,4 - 36,0) i AC-armen.
The median TTP was 37.3 weeks (95% CI: 33.4 - 42.1) in AT arm and 31.9 weeks (95% CI: 27.4 - 36.0) in AC arm.
• Stevens-Johnson syndrom og toksisk epidermal nekrolyse (blærer, afskrælning eller blødning på dele af huden (herunder dine læber, øjne, mund, næse, kønsorganer, hænder eller fødder) med eller uden udslæt.
• Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN) (blistering, peeling or bleeding on any part of your skin (including your lips, eyes, mouth, nose, genitals, hands or feet) with or without a rash.
TAXOTERE blev administreret som infusion over 1 time, alle andre lægemidler blev givet intravenøst på dag 1 hver 3. uge.
TAXOTERE was administered as a 1-hour infusion, all other medicinal products were given intraveinously on day 1 every three weeks.
Samlet medial overlevelse (måneder) Alle patienter
Number of patients Median overall survival (months) All patients
Antallet af metastatiske prostatskræft patienter
Number of metastatic prostate cancer patients
Post-menopausal * Hazard ratio (TAC/FAC) på mindre end 1 indikerer, at der er en sammenhæng mellem TAC og en længere sygdoms-fri overlevelse, sammenlignet med FAC.
*a hazard ratio (TAC/FAC) of less than 1 indicates that TAC is associated with a longer disease free survival compared to FAC.
Kasser ubrugt indhold på passende måde i henhold til gældende retningslinjer.
Discard unused contents appropriately in accordance with local requirements.
Hvis det ikke anvendes straks, er opbevaringstid og -forhold brugerens ansvar og vil normalt ikke være længere end 6 timer ved opbevaring under 25°C inklusive den time, patienten får infusionen.
If not used immediately, in-use storage times and conditions are the responsibility of the user and would normally not be longer than 6 hours below 25°C including the one hour infusion.
TAXOTERE i kombination med doxorubicin og cyclophosphamid er indiceret til adjuverende behandling af patienter med:
TAXOTERE in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with:
TAXOTERE i kombination med doxorubicin
TAXOTERE in combination with doxorubicin
Præmixen indeholder 10 mg/ml docetaxel og skal bruges straks efter tilberedning.
The premix solution contains 10 mg/ml docetaxel and should be used immediately after preparation.
Alvorlige kutane bivirkninger (SCARs) så som Stevens-Johnson syndrom (SJS), toksisk epidermal nekrolyse (TEN) og akut generaliseret eksantematøs pustulose (AGEP) er blevet rapporteret i forbindelse med docetaxel behandling.
Severe Cutaneous Adverse Reactions (SCARs) such as Stevens-Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (TEN) and Acute Generalized Exanthematous Pustulosis (AGEP) have been reported with docetaxel treatment.
Infektioner (G3/4: 5,7 %; inklusive sepsis og pneumoni, letal hos
Infections (G3/4: 5.7%; including sepsis and pneumonia, fatal in
For holdbarhed i infusionspose: Se indlægssedlen.
Shelf life in infusion bag: see the leaflet.
Der er rapporter om dissemineret intravaskulær koagulation (DIC), ofte i forbindelse med sepsis eller multiorgan-svigt.
Disseminated intravascular coagulation (DIC), often in association with sepsis or multi-organ failure, has been reported.
Med primær G-CSFprofylakse (n = 421) n (%)
With primary G-CSF prophylaxis (n = 421) n (%)
Grad 1 (inklusiv grader, der ikke er fastsat)
Histological grade Grade1 (includes grade not assessed) Grade 2
TAXOTERE må ikke anvendes efter udløbsdatoen vist på karton, blisterpakning og hætteglas.
TAXOTERE should not be used after the expiry date shown on the carton, blister pack and vials.
Ved den mediane opfølgningsperiode på 77 måneder blev der vist signifikant længere sygdoms-fri overlevelse (DFS) i TAC-armen sammenlignet med FAC-armen.
At the median follow-up time of 77 months, significantly longer disease-free survival for the TAC arm compared to the FAC arm was demonstrated.
”ne” indikerer at dette ikke kunne estimeres eller ikke blev nået.
(26.8-ne) TTP = time to progression; “ne” indicates that it could not be estimated or it was not yet reached.
Den bør anvendes inden for 6 timer (inklusive den ene time til i.v.-infusion).
It should be used within 6 hours (including the one hour infusion intravenous administration).
Alt materiale, som har været brugt i forbindelse med fortynding og infusion, skal bortskaffes i henhold til standardprocedurer.
All materials that have been utilised for dilution and administration should be disposed of according to standard procedures.