natgillin/translations-raw huggingface dataset:
Virkningen kan være kvantitativt forskellig afhængig af tumortype, såvel som af samtidige genetiske ændringer (se pkt. 
The effect may be quantitatively different depending on tumour type, as well as on concomitant genetic alterations (see section 5.1).
Den beregnede dosisvolumen bør afrundes til den nærmeste 0,1 ml. 
The calculated dose volume should be rounded to the nearest 0.1 mL.
Patienter med primære CNS-tumorer 
Patients with primary CNS tumours
Hver karton indeholder en flaske med 100 ml oral opløsning. 
Each carton contains one bottle of 100 mL oral solution.
Der blev observeret en let øget Cmax med hhv. 1,1; 1,1 og 1,5 gange. 
Cmax was observed to increase slightly by 1.1, 1.1 and 1.5-fold respectively.
Hovedparten af bivirkninger var grad 1 eller grad 2 i sværhedsgrad (se tabel 3), og de gik væk uden dosismodifikationer eller seponering af VITRAKVI. 
The majority of adverse reactions were Grade 1 or 2 in severity (see Table 3) and were resolved without VITRAKVI dose modification or discontinuation.
Studie 3“SCOUT” NCT02637687 
Study 3 “SCOUT” NCT02637687
Natriumdihydrogenphosphatdihydrat (E 339) Citronsyre (E 330) 
Sodium dihydrogen phosphate dihydrate (E 339) Citric acid (E 330)
Hvis patienten kaster op efter indtagelse af en dosis, må patienten ikke tage en til dosis som erstatning for den dosis, der blev kastet op. 
If the patient vomits after taking a dose, the patient should not take an additional dose to make up for vomiting.
- Sæt låget på flasken og luk flasken grundigt - lad adapteren blive i flasken. 
Put the bottle cap on and tightly close the bottle - leave the adapter in the bottle.
Virkning af stoffer, der forhøjer gastrisk pH på larotrectinib Larotrectinib har en pH-afhængig opløselighed. 
Effect of gastric pH-elevating agents on larotrectinib Larotrectinib has pH-dependent solubility.
Den målte virkning af eventuelle samtidige genomiske ændringer på larotrectinib er angivet nedenfor (se klinisk virkning). 
The measured impact of any concomitant genomic alterations on larotrectinib efficacy is provided below (see clinical efficacy).
Hos 85 patienter med bred molekylær karakterisering før behandling med larotrectinib, var ORR 58 % hos 48 patienter, som havde andre genomiske forandringer ud over NTRK-genfusionen, og ORR var 84 % hos 37 patienter uden andre genomiske forandringer. 
In 85 patients with wide molecular characterisation before larotrectinib treatment, the ORR in 48 patients who had other genomic alterations in addition to NTRK gene fusion was 58%, and in 37 patients without other genomic alterations ORR was 84%.
Virkning af larotrectinib på andre transportersubstrater In vitro studier indikerer, at larotrectinib er en inhibitor af OATP1B1. 
Effect of larotrectinib on other transporter substrates In vitro studies indicate that larotrectinib is an inhibitor of OATP1B1.
Bivirkningerne gangbesvær (17 % versus 3 % hos patienter under 65 år) og forhøjet basisk fosfatase i blodet (4 % versus 2 % hos patienter under 65 år) var hyppigere hos patienter i alderen 65 år eller ældre. 
The adverse reactions gait disturbance (17% versus 3% in under 65 years), and blood alkaline phosphatase increased (4% versus 2% in under 65 years) were more frequent in patients of 65 years or older.
Grad 3 bivirkninger omfattede to tilfælde med nedsat neutrofiltal (neutropeni) og ét tilfælde af anæmi. 
reactions included two cases Neutrophil count decreased (Neutropenia) and one case of anaemia.
Hvis du har spørgsmål om, hvordan VITRAKVI virker, eller hvorfor du har fået det ordineret, skal du spørge lægen, apotekspersonalet eller sygeplejersken. 
If you have any questions on how VITRAKVI works or why it has been prescribed for you, ask your doctor, pharmacist or nurse.
VITRAKVI påvirker i moderat grad evnen til at føre motorkøretøj og betjene maskiner. 
VITRAKVI has a moderate influence on the ability to drive and use machines.
In vitro studier indikerer, at larotrectinib ikke er substrat for OATP1B1 eller OATP1B3. 
In vitro studies indicate that larotrectinib is not a substrate for either OATP1B1 or OATP1B3.
På analysetidspunktet var den mediane varighed af responset ikke nået, 75 % af patienterne havde et igangværende respons, hvoraf det blev estimeret, at 88 % af dette respons ville vare i 6 måneder eller længere, og 75 % af responset ville vare i 12 måneder eller længere. 
At the time of analysis, the median duration of response had not been reached, 75% patients had responses which were ongoing with an estimated 88% of responses lasting 6 months or longer and 75% of responses lasting 12 months or longer.
For de fleste neurologiske reaktioner opstod disse i løbet af de første 3 måneders behandling. 
For the majority of neurologic reactions, onset occurred within the first three months of treatment.
Hver karton indeholder 1 børnesikret plastbeholder indeholdende 56 hårde gelatinekapsler. 
Each carton contains 1 child-resistant plastic bottle containing 56 hard gelatine capsules.
Hos cancerpatienter, der får VITRAKVI-kapsler, opnås maksimale plasmaniveauer (Cmax) af larotrectinib ca. 1 time efter dosering. 
In cancer patients given VITRAKVI capsules, peak plasma levels (Cmax) of larotrectinib were achieved at approximately 1 hour after dosing.
- Skub stemplet helt ind i sprøjten, og sæt dernæst sprøjten på adapterens åbning. 
Push the plunger fully into the syringe and then put the syringe in the adapter opening.
Der er ikke udført carcinogenicitetsstudier med larotrectinib. 
Carcinogenicity studies have not been performed with larotrectinib.
Larotrectinib var ikke mutagent i bakterielle revers mutationsanalyser (Ames) og i in vitro mutageneseanalyser hos pattedyr. 
Larotrectinib was not mutagenic in bacterial reverse mutation (Ames) assays and in in vitro mammalian mutagenesis assays.
- parahydroxybenzoat: det kan give allergiske reaktioner (kan optræde efter behandlingen) 
- parahydroxybenzoate: it may cause allergic reactions (possibly delayed).
In-frame genfusionshændelser, som resultat af kromosomal omarrangering af de humane gener NTRK1, NTRK2 og NTRK3, fører til dannelsen af onkogene TRK-fusionsproteiner. 
In-frame gene fusion events resulting from chromosomal rearrangements of the human genes NTRK1, NTRK2, and NTRK3 lead to the formation of oncogenic TRK fusion proteins.
Det poolede primære analysesæt for virkning omfattede 93 patienter med TRKfusionspositiv cancer inkluderet fra de 3 studier, der havde målbar sygdom vurderet ved RECIST v1.1, en ikke-CNS primær tumor og hvor de fik mindst en dosis larotrectinib. 
The pooled primary analysis set of efficacy includes 93 patients with TRK fusion-positive cancer enrolled across the three studies that had measurable disease assessed by RECIST v1.1, a non-CNS primary tumour and received at least one dose of larotrectinib.
De kliniske tegn på mave-tarm-toksicitet var dosisbegrænsende hos aber. 
Clinical signs of gastrointestinal toxicity were dose limiting in monkeys.
SD: stabil sygdom + benævner igangværende respons a analyse foretaget af uafhængig bedømmelseskomité med RECIST 1.1 b patienter med en primær CNS-tumor blev evalueret ifølge vurdering af investigator ved hjælp af enten RANO eller 
SD: stable disease + denotes ongoing response a independent review committee analysis by RECIST v1.1 b patients with a primary CNS tumour were evaluated per investigator assessment using either RANO or RECIST v1.1
Virkning af larotrectinib på CYP3A-substrater 
Effect of larotrectinib on CYP3A substrates
Virkning af larotrectinib på CYP2B6-substrater 
Effect of larotrectinib on CYP2B6 substrates
Øvrige indholdsstoffer: - Renset vand - Saccharose - Hydroxypropylbetadex - Glycerol (E 422) - Sorbitol (E 420) - Natriumcitrat (E 331) - Natriumdihydrogenphosphatdihydrat (E 339) - Citronsyre (E 330) - Propylenglycol (E 1520) - Kaliumsorbat (E 202) - Methylparahydroxybenzoat (E 218) - Citrusfrugtsmag - Naturlig smag 
The other ingredients are: - Purified water - Sucrose - Hydroxypropylbetadex - Glycerol (E 422) - Sorbitol (E 420) - Sodium citrate (E 331) - Sodium dihydrogen phosphate dihydrate (E 339) - Citric acid (E 330) - Propylene glycol (E 1520) - Potassium sorbate (E 202) - Methyl parahydroxybenzoate (E 218) - Citrus fruit flavour - Natural flavour
Parahydroxybenzoat: kan give allergiske reaktioner (kan optræde efter behandlingen). 
Parahydroxybenzoate: may cause allergic reactions (possibly delayed).
EU/1/19/1385/003 - VITRAKVI 20 mg/ml oral opløsning 
EU/1/19/1385/003 - VITRAKVI 20 mg/mL oral solution
For yderligere at bekræfte den passende dosis hos pædiatriske patienter, skalindehaveren af markedsføringstilladelsen indsende en opdateret pop-PKmodel baseret på yderligere PK-prøveudtagning hos patienter i alderen 1 måned til 6 år fra LOXO-TRK-15003 (SCOUT)-studiet. 
In order to further confirm the appropriate dose recommended in paediatric patients, the MAH should submit an updated pop PK model based on additional PK sampling in patients aged 1 month to 6 years from study LOXO-TRK-15003 (SCOUT).
Arealet under kurven over plasmakoncentration mod tid (AUC) og den maksimale plasmakoncentration (Cmax) af larotrectinib efter en enkelt dosis hos raske, voksne personer var dosisproportional op til 400 mg, og lidt mere end proportional ved doser på 600 til 900 mg. 
The area under the plasma concentration-time curve (AUC) and maximum plasma concentration (Cmax) of larotrectinib after a single dose in healthy adult subjects were dose proportional up to 400 mg and slightly greater than proportional at doses of 600 to 900 mg.
Fortæl det altid til lægen, apotekspersonalet eller sygeplejersken, hvis du tager anden medicin, for nylig har taget anden medicin eller planlægger at gøre det. 
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.
In vitro studier indikerer, at larotrectinib inducerer CYP2B6. 
In vitro studies indicate that larotrectinib induces CYP2B6.
Studie 2“NAVIGATE” NCT02576431 
Study 2 “NAVIGATE” NCT02576431
Pædiatriske patienter med et legemsoverfladeareal på under 1,0 m2 
Paediatric patients with body surface area less than 1.0 m2
Hos rotter blev svær toksicitet (STD10) observeret ved doser svarende til 1 til 2 gange det humane AUC ved den anbefalede kliniske dosis. 
In rats, severe toxicity (STD10) was observed at doses corresponding to 1- to 2-times the human AUC at the recommended clinical dose.
For yderligere at bekræfte den histologiske uafhængige virkning af larotrectinib og for at undersøge de primære og sekundære resistensmekanismer, skal indehaveren af markedsføringstilladelsen indsende en samlet analyse af den øgede prøvestørrelse inklusiv den færdige rapport af LOXO-TRK-15002 (NAVIGATE)-studiet. 
In order to further confirm the histology-independent efficacy of larotrectinib and to investigate the primary and secondary resistance mechanisms, the MAH should submit a pooled analysis for the increased sample size including the final report of study LOXO-TRK-15002 (NAVIGATE).
Efter inhibitoren er blevet seponeret i 3 til 5 eliminationshalveringstider, bør VITRAKVI-dosen genoptages ved dosis fra, før der påbegyndtes en CYP3A4-inhibitor (se pkt. 
After the inhibitor has been discontinued for 3 to 5 elimination half-lives, VITRAKVI should be resumed at the dose taken prior to initiating the CYP3A4 inhibitor (see section 4.5).
Infantil fibrosarkom (n = 13) 
Infantile fibrosarcoma (n=13)
Disse patienter skulle have fået tidligere standardbehandling, der var relevant for deres tumortype og sygdomsstadie eller hvor det, efter investigatorens mening, var nødvendigt at gennemgå radikal kirurgi (såsom amputation af lemmer, resektion af ansigt eller indgreb, der forårsager paralyse), eller hvor det var usandsynligt, at de kunne tolerere eller drage klinisk meningsfyldt fordel fra den tilgængelige standardbehandling for fremskreden sygdom. 
These patients were required to have received prior standard therapy appropriate for their tumour type and stage of disease or who, in the opinion of the investigator, would have had to undergo radical surgery (such as limb amputation, facial resection, or paralysis causing procedure), or were unlikely to tolerate, or derive clinically meaningful benefit from available standard of care therapies in the advanced disease setting.
Hovedparten af bivirkningerne, der førte til dosisreduktion, opstod i løbet af de første 3 måneders behandling. 
The majority of adverse reactions leading to dose reduction occurred in the first three months of treatment.
VITRAKVI permanent baseret på sværhedsgraden. 
Withhold or permanently discontinue VITRAKVI based on the severity.
97 procent af patienterne havde tidligere fået behandling for deres cancer, defineret som kirurgi, strålebehandling eller systemisk behandling. 
Ninety-seven percent of patients had received prior treatment for their cancer, defined as surgery, radiotherapy, or systemic therapy.
- Der skal bruges en egnet sprøjte til at administrere VITRAKVI til den nasogastriske sonde. 
- A suitable syringe should be used to administer VITRAKVI to the nasogastric feeding tube.
Størstedelen af grad 3-forhøjelserne var forbigående, og opstod i første eller anden måned af behandlingerne og faldt til grad 1 efter 3-4 måneder. 
Majority of Grade 3 elevations were transient appearing in first or second month of treatment and resolving to Grade 1 by months 3-4.
In vitro-studier indikerer, at larotrectinib ikke inhibere CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19 eller CYP2D6 ved klinisk relevante koncentrationer, og at det ikke er sandsynligt, at det vil påvirke clearance af substrater for disse CYP'er. 
In vitro studies indicate that larotrectinib does not inhibit CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, or CYP2D6 at clinically relevant concentrations and is unlikely to affect clearance of substrates of these CYPs.
- Fyld den orale sprøjte med en lille mængde opløsning ved at trække stemplet ned, og dernæst trykke stemplet op for at fjerne bobler. 
- Fill the oral syringe with small amount of solution by pulling the plunger down, then push the plunger upwards to remove any bubbles.
Hyppighed Spædbørn og småbørn (n=14)a 
Frequency Infants and toddlers (n=14)a
Kvinder i den fertile alder/Kontraception hos mænd og kvinder 
Women of childbearing potential / Contraception in males and females
• Fase 1, åbent, dosisoptrapnings- og forlængelsesstudie, forlængelsesfasen krævede tumorer med en NTRKgenfusion 
• Phase 1, open-label, dose escalation and expansion study; expansion phase required tumours with an NTRK gene fusion
- Vend flasken den rigtige vej op, og fjern den orale sprøjte fra flaskeadapteren. 
- Turn the bottle the right way up and remove the oral syringe from the bottle adapter.
c Unge (12 til <18 år): Der blev ikke rapporteret grad 3 eller 4 bivirkninger. 
c Adolescents (12 to <18 years): no Grades 3 and 4 reactions were reported.
Natriumcitrat (E 331) 
Sodium citrate (E 331)
I den samlede sikkerhedsdatabase (n = 125) var den maksimale observerede grad af neurologisk reaktion grad 3, som blev observeret hos tre (2 %) af patienterne, og omfattede svimmelhed (en patient, <1%) og paræstesi (to patienter, 1,6%). 
In the overall safety database (n=125), the maximum grade neurologic reaction observed was Grade 3 which was observed in three (2%) patients and included dizziness (one patient, <1%) and paraesthesia (two patients, 1.6%).
Udvis forsigtighed ved samtidig anvendelse af CYP3A-substrater med et snævert terapeutisk interval (f.eks. alfentanil, ciclosporin, dihydroergotamin, ergotamin, fentanyl, pimozid, quinidin, sirolimus eller tacrolimus) hos patienter, der tager VITRAKVI. 
Exercise caution with concomitant use of CYP3A substrates with narrow therapeutic range (e.g. alfentanil, ciclosporin, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus, or tacrolimus) in patients taking VITRAKVI.
Hvis noget af det ovenstående gælder for dig (eller hvis du er i tvivl), skal du kontakte lægen, apotekspersonalet eller sygeplejersken. 
If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse.
Der blev rapporteret ét tilfælde af grad 3 med nedsat neutrofiltal (neutropeni), paræstesi, myalgi, vægtstigning (unormal vægtforøgelse). 
One reported Grade 3 case each of Neutrophil count decreased (Neutropenia), Paraesthesia, Myalgia, Weight increased (Abnormal weight gain).
Larotrectinib var ikke teratogent og embryotoksisk ved daglige doser i løbet af perioden med organogenese til drægtige rotter og kaniner ved maternotoksiske doser, dvs. svarende til 32 gange (rotter) og 16 gange (kaniner) den humane AUC ved den anbefalede kliniske dosis. 
Larotrectinib was not teratogenic and embryotoxic when dosed daily during the period of organogenesis to pregnant rats and rabbits at maternotoxic doses, i.e. corresponding to 32-times (rats) and 16-times (rabbits) the human AUC at the recommended clinical dose.
• Voksne patienter (≥ 18 år) med fremskredne solide tumorer med en NTRK-genfusion 
• Adult patients (≥ 18 years) with advanced solid tumours with an NTRK gene fusion
VITRAKVI indeholder det aktive stof larotrectinib. 
VITRAKVI contains the active substance larotrectinib.
Det kan derfor ikke udelukkes, om samtidig administration af larotrectinib og OATP1B1-substrater (e.g. valsartan, statiner) kan forhøje deres eksponering. 
Therefore, it cannot be excluded whether co-administration of larotrectinib with OATP1B1 substrates (e.g. valsartan, statins) may increase their exposure.
Der blev observeret en stigning i larotrectinib Cmax og AUC0-inf, på hhv. 1,25 og 1,46 gange hos personer med nedsat nyrefunktion versus personer med normal nyrefunktion. 
An increase in larotrectinib Cmax and AUC0-inf, of 1.25 and 1.46-fold respectively was observed in renally impaired subjects versus those with normal renal function.
Samtidig administration med potente CYP3A4-inhibitore Hvis det er nødvendigt at administrere en potent CYP3A4-inhibitor samtidigt, bør VITRAKVI-dosen reduceres med 50 %. 
Co-administration with strong CYP3A4 inhibitors If co-administration with a strong CYP3A4 inhibitor is necessary, the VITRAKVI dose should be reduced by 50%.
Der blev ikke observeret nogen relevant systemisk toksicitet hos aber ved doser, der svarer til > 10 gange den humane AUC ved den anbefalede kliniske dosis. 
No relevant systemic toxicity was observed in monkeys at doses which correspond to > 10-times the human AUC at the recommended clinical dose.
In vitro-studier indikerer, at larotrectinib ikke inhibere transporterne BCRP, P-gp, OAT1, OAT3, OCT1, OCT2, OATP1B3, BSEP, MATE1 og MATE2-K ved klinisk relevante koncentrationer, og at det ikke er sandsynligt, at det vil påvirke clearance af substrater for disse transportere. 
In vitro studies indicate that larotrectinib does not inhibit the transporters BCRP, P-gp, OAT1, OAT3, OCT1, OCT2, OATP1B3, BSEP, MATE1 and MATE2-K at clinically relevant concentrations and is unlikely to affect clearance of substrates of these transporters.
Eftersom det på nuværende tidspunkt er ukendt, om larotrectinib kan reducere virkningen af systemisk virkende hormonelle kontraceptiva, bør kvinder, der bruger systemisk virkende hormonelle kontraceptiva, rådes til at tilføje en barrieremetode. 
As it is currently unknown whether larotrectinib may reduce the effectiveness of systemically acting hormonal contraceptives, women using systemically acting hormonal contraceptives should be advised to add a barrier method.
Indlægsseddel: Information til patienten VITRAKVI 25 mg hårde kapsler VITRAKVI 100 mg hårde kapsler larotrectinib Dette lægemiddel er underlagt supplerende overvågning. 
Package leaflet: Information for the patient VITRAKVI 25 mg hard capsules VITRAKVI 100 mg hard capsules larotrectinib This medicine is subject to additional monitoring.
Kontraception hos kvinder og mænd 
Contraception in female and male
- Luk flasken med det originale låg (lad adapteren blive på plads). 
- Close the bottle with the original bottle cap (leaving the adapter in place).
Brug af anden medicin sammen med VITRAKVI 
Other medicines and VITRAKVI
Virkning af CYP3A-, P-gp og BCRP-inhibitorer på larotrectinib Larotrectinib er et substrat for cytokrom P450 (CYP) 3A, P-glykoprotein (P-gp) og brystcancerresistensprotein (BCRP). 
Effect of CYP3A, P-gp and BCRP inhibitors on larotrectinib Larotrectinib is a substrate of cytochrome P450 (CYP) 3A, P-glycoprotein (P-gp) and breast cancer resistance protein (BCRP).
Den anbefalede dosis til voksne er 100 mg larotrectinib to gange dagligt, indtil sygdomsprogression, eller indtil der opstår uacceptabel toksicitet. 
The recommended dose in adults is 100 mg larotrectinib twice daily, until disease progression or until unacceptable toxicity occurs.
- Tryk langsomt stemplet ned, mens væskestrømmen er rettet mod indersiden af kinden, så den kan sluges naturligt. 
- Slowly depress the plunger, directing the liquid towards the inside cheek to allow for natural swallowing.
Alle patienterne havde tidligere fået behandling for deres cancer, defineret som kirurgi, strålebehandling eller systemisk behandling. 
All patients had received prior treatment for their cancer, defined as surgery, radiotherapy, or systemic therapy.
Transaminaseforhøjelser 
Transaminase elevations
Hos raske, voksne personer svarede AUC af larotrectinib som oral opløsning til kapslen, med Cmax 36 % højere med den orale opløsning. 
In healthy adult subjects, the AUC of larotrectinib in the oral solution formulation was similar to the capsule, with Cmax 36% higher with the oral solution formulation.
Ved den anbefalede dosis på 100 mg to gange dagligt, var steady-state aritmetiske gennemsnit (± standardafvigelse) Cmax og daglig AUC hos voksne hhv. 914 ± 445 ng/ml og 5410 ± 3813 ng*t/ml. 
At the recommended dose of 100 mg taken twice daily, steady-state arithmetic mean (± standard deviation) Cmax and daily AUC in adults were 914 ± 445 ng/mL and 5410 ± 3813 ng*h/mL, respectively.
Fordelen ved VITRAKVI er blevet klarlagt i studier med en enkelt arm, der omfatter en relativt lille prøve af patienter, hvis tumorer udviser NTRK-genfusioner. 
The benefit of VITRAKVI has been established in single arm trials encompassing a relatively small sample of patients whose tumours exhibit NTRK gene fusions.
Det vides på nuværende tidspunkt ikke, om larotrectinib kan reducere effektiviteten af systemisk virkende hormonelle kontraceptiva. 
It is currently unknown whether larotrectinib may reduce the effectiveness of systemically acting hormonal contraceptives.
100 mg én gang dagligt 
100 mg once daily
Samtidig administration af larotrectinib med CYP2C8, CYP2C9 eller CYP2C19 substrater (f.eks. repaglinid, warfarin, tolbutamid eller omeprazol) kan reducere deres eksponering. 
Co-administration of larotrectinib with CYP2C8, CYP2C9 or CYP2C19 substrates (e.g. repaglinide, warfarin, tolbutamide or omeprazole) may decrease their exposure.
Der blev observeret grad 2 ALAT- og ASAT-forhøjelser hos hhv. 9 (7 %) og 6 (5 %) patienter, og grad 1 ALAT- og ASAT-forhøjelser blev observeret hos hhv. 26 (21 %) og 28 (22 %) af patienterne. 
Grade 2 ALT and AST increases were observed in 9 (7%) and 6 (5%) of patients, respectively, and Grade 1 ALT and AST increases were observed in 26 (21%) and 28 (22%) of patients, respectively.
Der blev observeret grad 3 ALAT- og ASAT-forhøjelser hos hhv. 3 (2 %) og 2 (2 %) patienter. 
Grade 3 ALT and AST increases in 3 (2%) and 2 (2%) patients, respectively.
Tabel 5: Poolede effektresultater i solide tumorer inklusiv og eksklusiv primære CNS tumorer Effektparameter 
Table 5: Pooled efficacy results in solid tumours including and excluding primary CNS tumours Efficacy parameter
- Fyld sprøjten med en lille mængde opløsning ved at trække stemplet ned, og tryk så stemplet op for at fjerne alle store bobler fra sprøjten. 
Fill the syringe with a small amount of solution by pulling the plunger down, then push the plunger upwards to remove any large bubbles that are in the syringe.
Indigo carmine aluminium lake (E 132) Titandioxid (E 171) Propylenglycol (E 1520), Dimethicon 
Indigo carmine aluminium lake (E 132) Titanium dioxide (E 171) Propylene glycol (E 1520) Dimeticone