FrancophonIA/ELRC3.0 huggingface dataset:
English: Sodium bicarbonate
Danish: Natriumhydrogenkarbonat
English: Very rare dyspnoea, hyperventilation, pharyngeal pain
Danish: Dyspnø, hyperventilation, smerter i svælget
English: The time interval between the beginning of reconstitution and the end of intravenous infusion should not exceed two hours.
Danish: Der bør højst gå to timer fra rekonstituering påbegyndes til den intravenøse infusion er afsluttet.
English: • Local skin redness
Danish: • Lokal hudrødme
English: TIENAM is given intravenously (into a vein) over 20-30 minutes for a dose of ≤500 mg/500 mg or 40-60 minutes for a does of >500 mg/500 mg.
Danish: TIENAM gives intravenøst (i en vene) i løbet af 20-30 min for en dosis på 500 mg/500 mg eller mindre og i løbet af 40-60 min for en dosis på over 500 mg/500 mg.
English: • Irregular heartbeat, the heart beating forcefully or rapidly
Danish: • Uregelmæssige hjerteslag, kraftige eller hurtige hjerteslag
English: A reduction in dose is necessary when:  creatinine clearance is ≤ 70 ml/min/l.73 m2 (see Table 1) or
Danish: Reduceret dosis er påkrævet, når: kreatinin-clearance er ≤70 ml/min/1,73 m2 (se tabel 1) eller legemsvægt er <70 kg.
English: The plasma half-life of cilastatin is approximately one hour.
Danish: Cilastatins plasmahalveringstid var l time.
English: However, it can be administered into an I.V.
Danish: TIENAM kan dog administreres i et i.v.-system, gennem hvilket en lactatopløsning infunderes.
English: Very rare hyperhidrosis, skin texture changes
Danish: Hyperhidrose, forandringer i hudens struktur
English: Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription.
Danish: Fortæl det altid til lægen eller på apoteket, hvis De bruger anden medicin eller har brugt det for nylig.
English: The concomitant use of imipenem/cilastatin and valproic acid/sodium valproate is not recommended (see section 4.5).
Danish: Interaktion med valproinsyre Imipenem/cilastatin og valproinsyre/natriumvalproat bør ikke anvendes samtidigt (se pkt.
English: if you are allergic (hypersensitive) to imipenem, cilastatin or any of the other ingredients of TIENAM if you are allergic (hypersensitive) to other antibiotics such as penicillins, cephalosporins, or carbapenems
Danish: DET SKAL DE VIDE, FØR DE BEGYNDER AT BRUGE TIENAM Brug ikke TIENAM hvis De er overfølsom (allergisk) over for imipenem, cilastatin eller et af de øvrige indholdsstoffer hvis De er overfølsom (allergisk) over for andre antibiotika såsom penicilliner, cefalosporiner eller carbapenemer.
English: Rare hepatic failure, hepatitis
Danish: Leversvigt, hepatitis
English: No accumulation of imipenem in plasma or urine has been observed with regimens of TIENAM, administered as frequently as every six hours, in patients with normal renal function.
Danish: Hos patienter med normal nyrefunktion er der ikke observeret akkumulation af imipenem i plasma eller urin ved behandling med TIENAM, når det blev givet hver 6. time.
English: • very rare: affects less than 1 user in 10,000
Danish: • Meget sjældne: Forekommer hos færre end 1 ud af 10.000 brugere
English: What TIENAM looks like and contents of the pack TIENAM is a white to light yellow powder for solution for infusion in a glass vial.
Danish: Øvrige indholdsstoffer: Natriumhydrogencarbonat Udseende og pakningsstørrelser TIENAM er et hvidt til lysegult pulver til infussionsvæske i et hætteglas.
English: See section 4.4.
Danish: 4.4 og
English: Incompatibility
Danish: Uforligeligheder
English: • Disease of the brain, tingling sensation (pins and needles), localised tremor
Danish: • Sygdom i hjernen, prikkende, stikkende fornemmelse, lokaliseret skælven (tremor)
English: Clinical data are insufficient to recommend dosing for paediatric patients with renal impairment (serum creatinine > 2 mg/dl).
Danish: De kliniske data er utilstrækkelige, og der kan ikke gives nogen anbefalinger vedrørende dosering til børn med nyreinsufficiens (serumkreatinin >2 mg/dl) (se pkt.
English: • very common: affects more than 1 user in 10
Danish: • Meget almindelige: Forekommer hos flere end 1 ud af 10 brugere
English: In normal volunteers, intravenous infusion of TIENAM over 20 minutes resulted in peak plasma levels of imipenem ranging from 12 to 20 μg/ml for the 250 mg/250 mg dose, from 21 to 58 μg/ml for the 500 mg/500 mg dose, and from 41 to 83 μg/ml for the 1000 mg/1000 mg dose.
Danish: Hos raske, frivillige forsøgspersoner resulterede i.v.-infusion af TIENAM over 20 minutter maksimal imipenem-plasmakoncentration på mellem 12 til 20 g/ml ved dosis på 250 mg/250 mg, på mellem 21 og 58 g/ml ved dosis på 500 mg/500 mg og mellem 41 og 83 g ved dosis på 1.000 mg/1.000 mg.
English: Romania: TIENAM IV
Danish: Rumænien: TIENAM IV
English: For patients on haemodialysis, TIENAM is recommended only when the benefit outweighs the potential risk of seizures (see section 4.2).
Danish: Patienter i hæmodialyse bør kun behandles med TIENAM , hvis fordelene opvejer den potentielle risiko for krampeanfald (se pkt.
English: • Infections that you can catch during or after the delivery
Danish: • Infektioner under eller efter fødsel
English: Uncommon pancytopenia, neutropenia, leucopenia, thrombocytopenia, thrombocytosis
Danish: Eosinofili Ikke almindelig Pancytopeni, neutropeni, leukopeni, trombocytopeni, trombocytose
English: Imipenem-cilastatin sodium is haemodialyzable.
Danish: Imipenem-cilastatinnatrium er dialyserbart.
English: The mean peak plasma levels of imipenem following the 250 mg/250 mg, 500 mg/500 mg, and 1000 mg /1000 mg doses were 17, 39, and 66 μg/ml, respectively.
Danish: Den gennemsnitlige, maksimale imipenem-plasmakoncentration var efter 250 mg/250 mg, 500 mg/500 mg og 1.000 mg/1.000 mg doser hhv. 17, 39 og 66 g/ml.
English: • Blood disorders affecting the cell components of the blood and usually detected by blood tests
Danish: • Blodforstyrrelser, der påvirker blodets celler, og som normalt påvises via blodprøver (symptomerne kan være træthed, bleg hud og blå mærker, der er længe om at forsvinde)
English: Spain: TIENAM IV
Danish: Spanien: TIENAM IV
English: Very rare haemolytic anaemia, bone marrow depression
Danish: Hæmolytisk anæmi, knoglemarvsdepression
English: United Kingdom: Primaxin IV
Danish: Storbritannien: Primaxin IV
English: Iceland: Tienam
Danish: Island: Tienam
English: Medicines should not be disposed of via wastewater or household waste.
Danish: Af hensyn til miljøet må De ikke smide medicinrester i afløbet, toilettet eller skraldespanden.>
English: Uncommon hypotension
Danish: Ikke almindelig Hypotension Meget sjælden
English: • complicated skin and soft-tissue infections
Danish: • Komplicerede hud- og blødvævsinfektioner
English: The following information is intended for medical or healthcare professionals only: Each vial is for single use only.
Danish: Følgende oplysninger er tiltænkt læger og sundhedspersonale:
English: Norway: Tienam
Danish: Norge: Tienam
English: Very Rare fulminant hepatitis
Danish: Fulminant hepatitis
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains: imipenem 500 mg and cilastatin 500 mg.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hvert hætteglas indeholder: Imipenem 500 mg og cilastatin 500 mg.
English: Hepatic impairment No dose adjustment is recommended in patients with impaired hepatic function (see section 5.2).
Danish: Nedsat leverfunktion Dosisjustering anbefales ikke hos patienter med nedsat leverfunktion (se pkt.
English: France: TIENAM
Danish: Frankrig: TIENAM
English: The mean peak plasma levels of cilastatin following the 250 mg/250 mg, 500 mg/500 mg, and 1000 mg/1000 mg doses were 22, 42, and 72 µg/ml respectively.
Danish: Den gennemsnitlige, maksimale cilastatinplasmakoncentration var efter 250 mg/250 mg, 500 mg/500 mg og 1.000 mg/1.000 mg doser hhv. 22, 42 og 72 g/ml.
English: • common: affects 1 to 10 users in 100
Danish: • Almindelige: Forekommer hos mellem 1og 10 ud af 100 brugere
English: A teratology study in pregnant cynomolgus monkeys given imipenem-cilastatin sodium at doses of 40/40 mg/kg/day (bolus intravenous injection) resulted in maternal toxicity including emesis, inappetence, body weight loss, diarrhoea, abortion, and death in some cases.
Danish: Et teratologistudie med gravide cynomolgus-aber, som fik imipenem-cilastatinnatrium i doser på 40/40 mg/kg/dag (bolus i.v.
English: Peak plasma levels of cilastatin, following a 20 minute intravenous infusion of TIENAM, ranged from 21 to 26 μg/ml for the 250 mg/250 mg dose, from 21 to 55 μg/ml for the 500 mg/500 mg dose and from 56 to 88 μg/ml for the 1000 mg/1000 mg dose.
Danish: Efter 20 minutters i.v.-infusion af TIENAM varierede den maksimale plasmakoncentration af cilatstatin fra 21 til 26 g/ml ved dosis på 250 mg/250 mg, mellem 21 og 55 g/ml ved dosis på 500 mg/500 mg og mellem 56 og 88 g ved dosis på 1.000 mg/1.000 mg.
English: The AUC for imipenem following administration of 15/15 mg/kg per body weight of imipenem/cilastatin to paediatric patients was approximately 30% higher than the exposure in adults receiving a 500 mg/500 mg dose.
Danish: Imipenems AUC efter administration af 15/15 mg/kg legemsvægt til pædiatriske patienter var ca. 30% højere end eksponeringen hos voksne, der fik en dosis på 500 mg/500 mg. Ved den højere dosis var eksponeringen efter administration af 25/25 mg/kg imipenem/cilastatin til børn 9% højere end eksponeringen hos voksne, der fik en dosis på 1.000 mg/1.000 mg.
English: • intra- and post-partum infections
Danish: • infektioner under og efter fødsel
English: Uncommon urticaria, pruritus
Danish: Udslæt (f.eks. eksantematøst) Ikke almindelig Urticaria, pruritus Sjælden
English: Very rare polyarthralgia, thoracic spine pain
Danish: Polyartralgi, smerter i columna thoracalis
English: • rare: affects 1 to 10 users in 10,000
Danish: • Sjældne: Forekommer hos mellem 1- og 10 ud af 10.000 brugere
English: • Complicated urinary tract infections
Danish: • komplicerede urinvejsinfektioner
English: • complicated urinary tract infections
Danish: • Komplicerede urinvejsinfektioner
English: • Enterobacteriaceae 1: S ≤2 mg/l, R >8 mg/l
Danish: • Enterobacteriaceae 1: F ≤2 mg/l, R >8 mg/l
English: Estonia: TIENAM I.V.
Danish: Estland: TIENAM I.V.
English: Sweden: Tienam
Danish: Sverige: Tienam
English: Lithuania: TIENAM I.V.
Danish: Litauen: TIENAM I.V.
English: Therefore, no dose adjustment is recommended in patients with hepatic impairment (see section 4.2).
Danish: Derfor anbefales dosisjustering ikke hos patienter med leverinsufficiens (se pkt.
English: Poland: TIENAM
Danish: Polen: TIENAM
English: Bulgaria: Tienam
Danish: Bulgarien: Tienam
English: Belgium: Tienam
Danish: Belgien: Tienam
English: • Gram-positive anaerobes: S ≤2 mg/l, R >8 mg/l
Danish: • Gram-positive anaerober: F ≤2 mg/l, R >8 mg/l
English: Netherlands: TIENAM I.V.
Danish: Holland: TIENAM I.V.
English: • Seizures
Danish: • Udslæt
English: • uncommon: affects 1 to 10 users in 1,000
Danish: • Ikke almindelige: Forekommer hos mellem 1 og 10 ud af 1.000 brugere
English: Hungary: Tienam
Danish: Ungarn: Tienam
English: Uncommon seizures, myoclonic activity, dizziness, somnolence
Danish: Ikke almindelig Krampeanfald, myokloni, svimmelhed, døsighed
English: Each vial contains imipenem monohydrate equivalent to 500 mg imipenem anhydrate and cilastatin sodium equivalent to 500 mg cilastatin.
Danish: Hvert hætteglas indeholder imipenem monohydrat svarende til 500 mg imipenen og cilastatinnatrium svarende til 500 mg cilastatin.
English: • Moraxalla catarrhalis 4: S ≤2 mg/l, R >2 mg/l
Danish: • Moraxalla catarrhalis 4: F ≤2 mg/l, R >2 mg/l
English: • Streptococcus pneumoniae 4: S ≤2 mg/l, R >2 mg/l
Danish: • Streptococcus pneumoniae 4: F ≤2 mg/l, R >2 mg/l
English: • Haemophilus influenzae 4: S ≤2 mg/l, R >2 mg/l
Danish: • Haemophilus influenzae 4: F ≤2 mg/l, R >2 mg/l
English: Rare anaphylactic reactions
Danish: Anafylaktiske reaktioner
English: Dose adjustment is necessary for patients with impaired renal function (see section 4.2).
Danish: Dosisjustering er nødvendig hos patienter med nedsat nyrefunktion (se pkt.
English: Respiratory, thoracic and mediastinal disorders
Danish: Luftveje, thorax og mediastinum Meget sjælden
English: Streptococcus viridans group
Danish: Streptococcus viridans gruppe Gram-negative aerober:
English: SPECIAL STORAGE CONDITIONS Do not store above 25C
Danish: Må ikke opbevares ved temperaturer over 25°C.
English: Table 1: Reduced dose in adults with impaired renal function and body weight 70 kg*
Danish: Tabel 1: Reduceret dosis til voksne med nedsat nyrefunktion og legemsvægt ≥70 kg* Kreatinin-clearance (ml/min/1,73 m2)
English: Currently there are inadequate data to recommend use of TIENAM for patients on peritoneal dialysis.
Danish: TIENAM bør ikke anvendes til patienter i peritonealdialyse, da data er utilstrækkelige.
English: This medicinal product contains approximately 1.6 mEq (approximately 37.6 mg) of sodium per 500 mg dose which should be taken into consideration by patients on a controlled sodium diet.
Danish: TIENAM indeholder ca. 1,6meq (ca. 37,6 mg) natrium pr. 500 mg dosis.
English: 2: S ≤4 mg/l, R >8 mg/l
Danish: 2: F ≤4 mg/l, R >8 mg/l
English: : S ≤4 mg/l, R >8 mg/l
Danish: : F ≤4 mg/l, R >8 mg/l
English: : S ≤2 mg/l, R >8 mg/l
Danish: : F ≤2 mg/l, R >8 mg/l
English: • Complicated infections in the abdomen
Danish: • Komplicerede infektioner i maven
English: Contents of each vial must be transferred to 100 ml of an appropriate infusion solution (see section 6.2 and 6.3): 0.9% sodium chloride.
Danish: 6.2 og 6.3): 0,9% natriumchlorid.
English: • Inability of the kidney to perform normal function
Danish: • Unormal leverfunktion
English: Reconstitution
Danish: Fremstiller
English: • Other streptococci 4: S ≤2 mg/l, R >2 mg/l
Danish: • Andre streptokokker 4: F ≤2 mg/l, R >2 mg/l
English: Common thrombophlebitis
Danish: Tromboflebit
English: • Hearing loss
Danish: • Høretab
English: Slovak Republic: TIENAM i.v.
Danish: Slovakiet: TIENAM i.v.
English: • Rash
Danish: • Hudkløe
English: Breast-feeding
Danish: Gastroenterit
English: Dialysis patients, especially those with background central nervous system (CNS) disease, should be carefully monitored; for patients on haemodialysis, TIENAM is recommended only when the benefit outweighs the potential risk of seizures (see section 4.4).
Danish: Dialysepatienter, og særligt dem med sygdomme i centralnervesystemet (CNS), bør monitoreres omhyggeligt.
English: If you have further questions, ask your doctor or pharmacist.
Danish: Spørg lægen eller på apoteket, hvis der er mere, De vil vide.
English: If you use more TIENAM than you should
Danish: Hvis De har fået for meget TIENAM
English: This medicine has been prescribed for you.
Danish: Lægen har ordineret TIENAM til Dem personligt.
English: Children
Danish: Graviditet
English: • Itching of the vulva in women
Danish: • Kløe i de ydre kvindelige kønsorganer
English: Rare hearing loss
Danish: Nedsat nyrefunktion
English: • Inflammation of the liver
Danish: • Krampeanfald
English: Both doses should not be taken at the same time.
Danish: Begge doser bør ikke indtages samtidig.
English: Call a doctor immediately.
Danish: Ring omgående til en læge.
English: ● If you do plan to go into the sun:
Danish: · Hvis du planlægger at være ude i solen:
English: Among these patients, 457 were Caucasians.
Danish: Blandt disse patienter var 457 kaukasiske.
English: The maximum tolerated dose could not be determined.
Danish: Den maksimale tolererede dosis kunne ikke fastsættes.
English: No studies were performed regarding pre- and postnatal development.
Danish: Der blev ikke udført studier vedrørende præ- og postnatal udvikling.
English: Discontinue permanently.
Danish: Seponer permanent.
English: Vemurafenib is for oral use.
Danish: Vemurafenib er til oral anvendelse.
English: ● Risk Management Plan (RMP)
Danish: Risikostyringsplan (RMP)
English: Treatment not recommended.
Danish: Behandling anbefales ikke.
English: This is very important, as using more than one medicine at the same time can strengthen or weaken the effect of medicines.
Danish: Dette er meget vigtigt, da brug af flere slags medicin på samme tid kan forstærke eller mindske virkningen af medicinen.
English: Interrupt treatment until grade 0 - 1.
Danish: Afbryd behandling indtil grad 0-1.
English: ● This will help to protect you against sunburn.
Danish: · Dette vil hjælpe med at beskytte dig mod solskoldninger.
English: Biliary excretion appears to be another important elimination pathway.
Danish: Galdeudskillelse synes at være en anden vigtig eliminationsvej.
English: The study included two simultaneously enrolling cohorts:
Danish: Studiet havde to samtidigt rekrutterede kohorter:
English: It is unclear whether this is a gender or a body size effect.
Danish: Det vides ikke, om det er en køns- eller kropstørrelseseffekt.
English: ● Swallow the tablets whole with a glass of water.
Danish: · Slug tabletterne hele med et glas vand.
English: 0 (not applicable)
Danish: 0 (ikke relevant)
English: The following convention has been used for the classification of frequency:
Danish: Følgende opdeling er blevet brugt til klassificering af hyppighed:
English: ● Take 4 tablets in the morning.
Danish: · Tag 4 tabletter om morgenen.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/12/751/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/12/751/001
English: Tell your doctor if you are pregnant or planning to become pregnant.
Danish: Fortæl lægen, hvis du er gravid eller planlægger at blive gravid.
English: INFORMATION IN BRAILLE zelboraf
Danish: INFORMATION I BRAILLESKRIFT Zelboraf
English: Post-hoc survival analyses were undertaken thereafter as described in table 7.
Danish: Post hoc-overlevelsesanalyser blev foretaget derefter, som beskrevet i tabel 7.
English: Censored results at time of cross-over
Danish: Censurerede resultater på overkrydsningstidspunktet
English: Stage IIIc/M1A/M1B
Danish: Stadie IIIc/M1A/M1B
English: QTc>500 ms at baseline
Danish: QTc > 500 ms ved baseline
English: A total of 146 patients were enrolled.
Danish: I alt inkluderedes 146 patienter.
English: The median age was 52 years with 19% of patients being older than 65 years.
Danish: Den mediane alder var 52 år, hvor 19 % af patienterne var ældre end 65 år.
English: If necessary, your doctor may decide to interrupt your treatment temporarily or stop it altogether.
Danish: Lægen kan om nødvendigt beslutte, at afbryde din behandling midlertidig eller stoppe den helt.
English: However, the differences in exposure are not large enough to warrant dose adjustment based on body size or gender.
Danish: Forskellene i eksponering er dog ikke store nok til at berettige en dosisjustering baseret på kropsstørrelse eller køn.
English: Do not use any more Zelboraf until you have spoken to a doctor.
Danish: Tag ikke mere Zelboraf, før du har talt med en læge.
English: No new safety signals were observed in a clinical study with six adolescent patients.
Danish: Der blev ikke observeret nye sikkerhedssignaler i et klinisk studie med 6 unge patienter.
English: ● Additionally, your doctor needs to inspect your head, your neck, your mouth, your lymph glands and you will undergo CT scans regularly.
Danish: · Ydermere skal din læge undersøge dit hoved, din hals, din mund, dine lymfeknuder og du vil regelmæssigt få foretaget CT-scanninger.
English: ● Do not take a double dose to make up for a forgotten dose.
Danish: · Du må ikke tage en dobbeltdosis som erstatning for den glemte dosis.
English: All terms included are based on the highest percentage observed among phase II and phase III clinical trials.
Danish: Alle inkluderede termer er baseret på højeste procent observeret blandt kliniske fase II- og fase III-studier.
English: Side effects are listed below by frequency:
Danish: Bivirkninger er anført nedenfor efter hyppighed:
English: They are oval with “VEM” engraved on one side.
Danish: De er ovale og mærket med ”VEM” på den ene side.
English: ● wear clothing which protects your skin, including your head and face, arms and legs;
Danish: · brug tøj, som beskytter din hud, inklusive dit hoved og ansigt, arme og ben
English: The tablets are to be swallowed whole with water.
Danish: Tabletterne skal sluges hele med vand.
English: ● If your doctor finds this type of skin cancer, he or she will treat it or send you to another doctor for treatment.
Danish: · Hvis lægen finder denne type af hudkræft, vil lægen behandle den eller sende dig til behandling hos en anden læge.
English: Non-Caucasian patients
Danish: Patienter af ikke-kaukasisk herkomst
English: Thus close monitoring is warranted especially after the first few weeks of treatment as accumulation may occur over an extended period of time (several weeks).
Danish: Tæt monitorering er derfor påkrævet, især efter de første uger af behandling, da akkumulation kan forekomme over en længere periode (adskillige uger).
English: Then take 4 tablets in the evening.
Danish: Tag derefter 4 tabletter om aftenen.
English: Then take the next dose at the usual time.
Danish: Tag derefter den næste dosis til sædvanlig tid.
English: Number of crossover patients (%)
Danish: Antal af overkrydsende patienter (%)
English: Vemurafenib exhibits high inter-patient variability.
Danish: Vemurafenib udviser høj variabilitet mellem patienter.
English: This may affect the activity of Zelboraf.
Danish: Dette kan påvirke virkningen af Zelboraf.
English: LDH: Lactate Dehydrogenase, ECOG PS: Eastern Cooperative Oncology Group Performance Status
Danish: LDH: Laktatdehydrogenase, ECOG-PS: Eastern Oncology Group Performance Status
English: The co-primary efficacy endpoints of the study were overall survival (OS) and progression-free survival (PFS).
Danish: Studiets co-primære effektendepunkter var samlet overlevelse (OS) og progressionsfri overlevelse (PFS).
English: In addition ECG monitoring every month during the first three months is recommended.
Danish: Endvidere anbefales ekgmonitorering hver måned under de første tre måneders behandling.
English: (y) As of December 30, 2010, a total of 549 patients were evaluable for PFS and 439 patients were evaluable for overall response rate.
Danish: Per 30.december 2010 var i alt 549 patienter evaluerbare for PFS, og 439 patienter var evaluerbare for den samlede responsrate.
English: ● If you experience side effects, your doctor may decide to carry on your treatment but lower your dose.
Danish: · Hvis du oplever bivirkninger, kan lægen beslutte at fortsætte din behandling, men nedsætte din dosis.
English: It is currently unknown whether vemurafenib is a substrate also to other transport proteins.
Danish: Det vides ikke på nuværende tidspunkt, om vemurafenib også er substrat for andre transportproteiner.
English: It is important to keep taking Zelboraf for as long as your doctor prescribes it for you.
Danish: Det er vigtigt, at du bliver ved med at tage Zelboraf, så længe som din læge har ordineret det til dig.
English: Patients should be instructed to inform their physicians upon the occurrence of any skin changes.
Danish: Patienter bør instrueres i, at informere lægen ved enhver forekomst af hudændringer.
English: The study was terminated due to low enrollment.
Danish: Studiet blev stoppet på grund af lav rekruttering.
English: Warnings and precautions Talk to your doctor before taking Zelboraf.
Danish: Advarsler og forsigtighedsregler Tal med lægen, før du tager Zelboraf.
English: It can only be used in patients whose cancer has a change (mutation) in the “BRAF” gene.
Danish: Det kan kun bruges til patienter, hvis kræftsygdom har en ændring (mutation) i ”BRAF”-genet.
English: CuSCC usually occurred early in the course of treatment with a median time to the first appearance of 7 to 8 weeks.
Danish: CuSCC forekom sædvanligvis tidligt i behandlingsforløbet med en mediantid til første forekomst på 7 til 8 uger.
English: Table 8 shows the treatment effect for all pre-specified stratification variables which are established as prognostic factors.
Danish: Tabel 8 viser behandlingseffekt for alle præspecificerede stratificeringsvariabler, som er etablerede som prognostiske faktorer.