FrancophonIA/ELRC3.0 huggingface dataset:
English: Excipient with known effect: each 150 mg film-coated tablet contains 0.84 mg of soya lecithin.
Danish: Hver 150 mg filmovertrukken tablet indeholder 0,84 mg sojalecithin.
English: Excipient with known effect: each 25 mg film-coated tablet contains 0.14 mg of soya lecithin.
Danish: Hver 25 mg filmovertrukken tablet indeholder 0,14 mg sojalecithin.
English: CELSENTRI 300 mg twice daily and statins can be co-administered without dose adjustment.
Danish: Celsentri 300 mg 2 gange daglig og statiner kan anvendes samtidigt uden dosisjustering.
English: Before taking CELSENTRI it has to be confirmed that only CCR5-tropic HIV-1 is detectable (i.e. CXCR4 or dual/mixed tropic virus not detected) using an adequately validated and sensitive detection method on a newly drawn blood sample.
Danish: Før Celsentri anvendes, skal det være bekræftet, at patienterne er smittet kun med hiv 1-virus med verificeret CCR5-tropisme (dvs. CXCR4 eller dual/mixed tropisme må ikke være verificeret).
English: CELSENTRI 75 mg film-coated tablets maraviroc
Danish: LÆGEMIDLETS NAVN Celsentri 75 mg filmovertrukne tabletter maraviroc
English: Darunavir/ritonavir 600 mg/100 mg BID (maraviroc 150 mg BID)
Danish: Darunavir/ritonavir 600 mg/100 mg 2 gange daglig (maraviroc 150 mg 2 gange daglig)
English: Ketoconazole 400 mg QD (maraviroc 100 mg BID)
Danish: Ketoconazol 400 mg 1 gang daglig (maraviroc 100 mg 2 gange daglig)
English: CELSENTRI 20 mg/ml oral solution
Danish: LÆGEMIDLETS NAVN Celsentri 20 mg/ml oral opløsning
English: Postural hypotension (see section 4.4) uncommon
Danish: Postural hypotension (se pkt.
English: The pharmacokinetics of maraviroc has not been studied in subjects with severe hepatic impairment (see sections 4.2 and 4.4).
Danish: Maravirocs farmakokinetik er ikke undersøgt hos forsøgspersoner med svært nedsat leverfunktion (se pkt.
English: Each film-coated tablet contains 300 mg of maraviroc.
Danish: Celsentri 300 mg filmovertrukne tabletter Hver filmovertrukken tablet indeholder 300 mg maraviroc.
English: Dose adjustment is necessary in patients with renal impairment receiving maraviroc with potent CYP3A4 inhibitors (see sections 4.2 and 4.4 and 4.5).
Danish: Dosisjustering er nødvendig hos patienter med nedsat nyrefunktion, der behandles med maraviroc og potente CYP3A4-hæmmere (se pkt.
English: Elvitegravir Cmax: ↔ 1.01
Danish: Levonorgestrel Cmax: ↔ 1,01
English: Ethinylestradiol.
Danish: ORALE KONTRACEPTIVA Ethinylestradiol 30 mikg.
English: CELSENTRI has not been tested in children under the age of 2 or weighing less than 10 kg.
Danish: Celsentri er ikke blevet undersøgt hos børn under 2 år eller som vejer under 10 kg. Celsentri frarådes derfor til børn under 2 år eller som vejer under 10 kg.
English: If you notice any of these symptoms:
Danish: Hvis du får nogen af følgende symptomer, mens du tager Celsentri:
English: Saquinavir/ritonavir 1000 mg/100 mg BID (maraviroc 100 mg BID)
Danish: Saquinavir/ritonavir 1.000 mg/100 mg 2 gange daglig (maraviroc 100 mg 2 gange daglig)
English: Saquinavir/ritonavir concentrations not measured, no effect is expected.
Danish: Saquinavir/ritonavir koncentrationer er ikke undersøgt.
English: CELSENTRI dose should be increased to 600 mg twice daily when co-administered with efavirenz in the absence of a potent CYP3A4 inhibitor.
Danish: Celsentri-dosis bør øges til 600 mg 2 gange daglig, når det anvendes samtidigt med efavirenz under fravær af potente CYP3A4-hæmmere.
English: Blue, biconvex, oval film-coated tablets, approximate dimensions 4.6 mm x 8.0 mm and debossed with “MVC 25”.
Danish: Blå, bikonvekse, ovale filmovertrukne tabletter, der måler ca. 4,6 mm x 8,0 mm og er præget med “MVC 25”.
English: Studies in Treatment-Naïve Adult Patients Infected with CCR5-tropic Virus
Danish: Studier med Behandlingsnaive Voksne Patienter inficeret med CCR5-tropismevirus
English: CELSENTRI 300 mg twice daily and digoxin can be co-administered without dose adjustment.
Danish: Celsentri 300 mg 2 gange daglig og digoxin kan anvendes samtidigt uden dosisjustering.
English: Therefore CELSENTRI is not recommended for children younger than 2 years, or weighing less than 10 kg.
Danish: Celsentri er ikke blevet undersøgt hos børn under 2 år eller som vejer under 10 kg. Celsentri kan derfor ikke anbefales til børn under 2 år eller som vejer under 10 kg.
English: Protease Inhibitors (PIs) Atazanavir 400 mg QD (maraviroc 300 mg BID)
Danish: Proteasehæmmere Atazanavir 400 mg 1 gang daglig (maraviroc 300 mg 2 gange daglig)
English: celsentri 25 mg
Danish: INFORMATION I BRAILLE-SKRIFT celsentri 25 mg
English: Etravirine 200 mg BID (maraviroc 300 mg BID)
Danish: Etravirin 200 mg 2 gange daglig (maraviroc 300 mg 2 gange daglig)
English: Symptoms may include:  muscle weakness  weakness beginning in the hands and feet and moving up towards the trunk of the body  palpitations or tremor  hyperactivity (excessive restlessness and movement).
Danish: • svaghed, der starter i hænder og fødder og bevæger sig op ad kroppen
English: Carton for bottle containing 20 mg/ml maraviroc oral solution
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Karton til flaske indeholdende 20 mg/ml maraviroc oral opløsning
English: CELSENTRI 300 mg twice daily and buprenorphine can be co-administered without dose adjustment.
Danish: Celsentri 300 mg 2 gange daglig og buprenorphin kan anvendes samtidigt uden dosisjustering.
English: ANTI-INFECTIVES
Danish: • lungeinfektion
English: Raltegravir 400 mg BID (maraviroc 300 mg BID)
Danish: Raltegravir 400 mg 2 gange daglig (maraviroc 300 mg 2 gange daglig)
English: CELSENTRI 25 mg film-coated tablets maraviroc
Danish: LÆGEMIDLETS NAVN Celsentri 25 mg filmovertrukne tabletter maraviroc
English: ANTIFUNGALS Ketoconazole 400 mg QD (maraviroc 100 mg BID)
Danish: SVAMPEMIDLER Ketoconazol 400 mg 1 gang daglig (maraviroc 100 mg 2 gange daglig)
English: Each film-coated tablet contains 75 mg of maraviroc.
Danish: Celsentri 75 mg filmovertrukne tabletter Hver filmovertrukken tablet indeholder 75 mg maraviroc.
English: Clarithromycin, Telithromycin
Danish: Cellulose, mikrokrystallinsk
English: CELSENTRI 300 mg twice daily and ribavirin can be co-administered without dose adjustment.
Danish: Celsentri 300 mg 2 gange dagligt og ribavirin kan anvendes samtidigt uden dosisjustering.
English: CELSENTRI 300 mg twice daily and raltegravir can be co-administered without dose adjustment.
Danish: Celsentri 300 mg 2 gange daglig og raltegravir kan anvendes samtidigt uden dosisjustering.
English: Fosamprenavir/ritonavir 700 mg/100 mg BID (maraviroc 300 mg BID)
Danish: Fosamprenavir/ritonavir 700 mg/100 mg 2 gange daglig (maraviroc 300 mg 2 gange daglig)
English: CELSENTRI 300 mg twice daily and methadone can be co-administered without dose adjustment.
Danish: Celsentri 300 mg 2 gange daglig og methadon kan anvendes samtidigt uden dosisjustering.
English: Studies in Treatment-Experienced Paediatric Patients Infected with CCR5-tropic Virus
Danish: Studier med Behandlingserfarne Pædiatriske Patienter inficeret med CCR5-tropismevirus
English: Each film-coated tablet contains 150 mg of maraviroc.
Danish: Celsentri 150 mg filmovertrukne tabletter Hver filmovertrukken tablet indeholder 150 mg maraviroc.
English: Package leaflet: information for the user CELSENTRI 20 mg /ml oral solution maraviroc
Danish: LÆGEMIDLETS NAVN Celsentri 20 mg/ml oral opløsning maraviroc
English: Blister Strip of 10 tablets of 150 mg maraviroc film-coated tablets
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIPS Blister med 10 tabletter med 150 mg maraviroc filmovertrukne tabletter
English: Celsentri 300 mg film-coated tablets maraviroc
Danish: LÆGEMIDLETS NAVN Celsentri 300 mg filmovertrukne tabletter maraviroc
English: Cmax: ↔ 1.04
Danish: Digoxin Cmax: ↔ 1,04
English: Ritonavir Cmax: ↔ 1.02 Ritonavir C12: ↓ 0.74
Danish: Ritonavir AUC12: ↔ 0,93 Ritonavir Cmax: ↔ 1,02
English: How to store CELSENTRI Contents of the pack and other information
Danish: Pakningsstørrelser og yderligere oplysninger
English: CELSENTRI 300 mg twice daily and pegylated interferon can be co-administered without dose adjustment.
Danish: Celsentri 300 mg 2 gange dagligt og pegyleret interferon kan anvendes samtidigt uden dosisjustering.
English: Blister Strip of 10 tablets of 300 mg maraviroc film-coated tablets
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIPS Blister med 10 tabletter med 300 mg maraviroc filmovertrukne tabletter
English: Lopinavir/ritonavir concentrations not measured, no effect is expected.
Danish: Lopinavir/ritonavir koncentrationer er ikke undersøgt.
English: boceprevir, telaprevir)  antibiotics (clarithromycin, telithromycin, rifampicin, rifabutin)  antifungal medicines (ketoconazole, itraconazole, fluconazole)  anticonvulsant medicines (carbamazepine, phenytoin, phenobarbital).
Danish: • anden medicin til behandling af hiv- eller hepatitis C-infektion (såsom atazanavir, cobicistat, darunavir, efavirenz, etravirin, fosamprenavir, indinavir, lopinavir, nelfinavir, ritonavir, saquinavir, boceprevir, telaprevir)
English: CELSENTRI 150 mg film-coated tablets maraviroc
Danish: LÆGEMIDLETS NAVN Celsentri 150 mg filmovertrukne tabletter maraviroc
English: 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 occur many months after initiation of treatment.
Danish: Autoimmune lidelser (såsom Graves sygdom og autoimmun hepatitis og autoimmun hepatitis) er også rapporteret at forekomme i forbindelse med immunreaktivering.
English: Lopinavir/ritonavir 400 mg/100 mg BID (maraviroc 300 mg BID)
Danish: Lopinavir/ritonavir 400 mg/100 mg 2 gange daglig (maraviroc 300 mg 2 gange daglig)
English: Carton for bottles containing 75 mg maraviroc film-coated tablets
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Karton til beholder indeholdende 75 mg maraviroc filmovertrukne tabletter
English: • feeling sick or being sick
Danish: • svimmelhed eller følelse af at besvime, når du rejser dig op
English: Carton for blister pack containing 150 mg maraviroc film-coated tablets
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Karton for blisterpakning for 150 mg maraviroc filmovertrukne tabletter
English: What CELSENTRI looks like and contents of the pack
Danish: Udseende og pakningsstørrelser
English: Carton for blister pack containing 300 mg maraviroc film-coated tablets
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Karton for blisterpakning for 300 mg maraviroc filmovertrukne tabletter
English: Each film-coated tablet contains 25 mg of maraviroc.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver filmovertrukken tablet indeholder 25 mg maraviroc.
English: Not studied, but both are potent CYP3A4 inhibitors and would be expected to increase maraviroc concentrations.
Danish: Clarithromycin, telithromycin Ikke undersøgt, men begge stoffer er potente CYP3A4-hæmmere, og de kan forventes at øge maraviroc koncentrationen.
English: CELSENTRI 300 mg twice daily and levonorgestrel can be co-administered without dose adjustment.
Danish: Celsentri 300 mg 2 gange daglig og levonorgestrel kan anvendes samtidigt uden dosisjustering.
English: Studies in Treatment-Experienced Adult Patients Infected with CCR5-tropic Virus
Danish: Studier med Behandlingserfarne Voksne Patienter inficeret med CCR5-tropismevirus
English: LIST OF EXCIPIENTS PHARMACEUTICAL FORM AND CONTENTS
Danish: LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE) Flaskens indhold:
English: CELSENTRI dose should be decreased to 150 mg twice daily when co-administered with etravirine and a PI.
Danish: Celsentri-dosis bør nedsættes til 150 mg 2 gange daglig, når det anvendes samtidigt med etravirin og en proteasehæmmer.
English: Carton for bottle containing 25 mg maraviroc film-coated tablets
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Karton til beholder indeholdende 25 mg maraviroc filmovertrukne tabletter
English: Rare side effects These may affect up to 1 in 1,000 people:
Danish: Kan forekomme hos op til 1 ud af 1.000 personer:
English: Virologic Escape
Danish: Udvikling af viral resistens
English: Each ml of oral solution contains 20 mg maraviroc
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver ml oral opløsning indeholder 20 mg maraviroc
English: CELSENTRI 300 mg twice daily and midazolam can be co-administered without dose adjustment.
Danish: Celsentri 300 mg 2 gange daglig og midazolam kan anvendes samtidigt uden dosisjustering.
English: Elvitegravir/ritonavir 150/100mg QD (maraviroc 150 mg BID)
Danish: Integrasehæmmere Elvitegravir/ritonavir 150/100 mg 1 gang daglig (maraviroc 150 mg 2 gange daglig)
English: NNRTI + PI Efavirenz 600 mg QD + lopinavir/ritonavir 400mg/100 mg BID (maraviroc 300 mg BID)
Danish: PROTEASEHÆMMERE Efavirenz 600 mg 1 gang daglig + lopinavir/ritonavir 400mg/100 mg 2 gange daglig (maraviroc 300 mg 2 gange daglig)
English: 30 film-coated tablets 60 film-coated tablets 90 film-coated tablets
Danish: LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE) 90 filmovertrukne tabletter.
English: CELSENTRI 300 mg twice daily and NRTIs can be co-administered without dose adjustment.
Danish: Celsentri 300 mg 2 gange daglig og NRTI kan anvendes samtidigt uden dosisjustering.
English: Sulphamethoxazole/trimethoprim concentrations not measured, no effect expected.
Danish: Maraviroc Cmax: ↔ 1,19) Sulphamethoxazol/trimethoprimkoncentrationer er ikke målt.
English: Bottle label - 75 mg film-coated tablets
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE Etiket til beholder - 75 mg filmovertrukne tabletter
English: Bottle label - 25 mg film-coated tablets
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE Etiket til beholder - 25 mg filmovertrukne tabletter
English: Zidovudine 300 mg BID (maraviroc 300 mg BID)
Danish: Zidovudin 300 mg 2 gange daglig (maraviroc 300 mg 2 gange daglig)
English: Maraviroc AUC12: ↓ 0.55
Danish: Maraviroc AUC12: ↓ 0,55 Maraviroc Cmax: ↓ 0,49
English: Zidovudine Cmax: ↔ 0.92
Danish: Ethinylestradiol Cmax: ↔ 0,99
English: CELSENTRI 300 mg twice daily and nevirapine can be co-administered without dose adjustment.
Danish: Celsentri 300 mg 2 gange daglig og ethinylestradiol kan anvendes samtidigt uden dosisjustering.
English: • skin rash or itching
Danish: • stive led
English: Do not open them.
Danish: Lad være at åbne dem.
English: Not Known (unknown frequency)
Danish: Ikke kendt (ukendt hyppighed)
English: Two dose reductions were required in 41% of patients.
Danish: To dosisreduktioner var påkrævet hos 41 % af patienterne.
English: The capsules should be swallowed whole and not opened.
Danish: Kapslerne skal synkes hele og må ikke åbnes.
English: Tell your doctor if any of these affect you.
Danish: Fortæl det til din læge, hvis nogen af disse påvirker dig.
English: Component of a 28 day pack, can't be sold separately.
Danish: Komponent af en 28-dages pakning, må ikke sælges separat.
English: Date of first authorisation: 21 March 2014 Date of latest renewal: 28 March 2019
Danish: Dato for første markedsføringstilladelse: 21. marts 2014 Dato for seneste fornyelse: 28. marts 2019
English: There are no data on human fertility.
Danish: Der er ingen data om human fertilitet.
English: To remove the capsules for your dose:
Danish: For at fjerne kapslerne for din dosis:
English: Number of subjects at risk Month
Danish: Antal forsøgspersoner med risiko Måned
English: Evaluations in juvenile rats (comparable to a <2 year old pediatric population) have not been performed.
Danish: Evalueringer hos juvenile rotter (sammenlignelig med <2 år gammel pædiatrisk population) er ikke udført.
English: You should continue to take this medicine until your doctor decides to stop your treatment.
Danish: Du bør fortsætte med at tage dette lægemiddel, indtil din læge beslutter at standse din behandling.
English: Tell your doctor straight away if you notice any of the following side effects - you may need urgent medical treatment:
Danish: Fortæl det straks til din læge, hvis du lægger mærke til nogen af følgende bivirkninger - du kan have behov for hurtig medicinsk behandling:
English: Centralized, independent, blinded review of the imaging data was used in the assessment of PFS and ORR.
Danish: Centraliseret, uafhængig, blindet gennemgang af data blev brugt ved vurderingen af PFS og ORR.
English: For an additional 115 subjects the RET mutational status could not be determined or was unclear.
Danish: For yderligere 115 forsøgspersoner kunne RET-mutationsstatus ikke bestemmes eller var uklar.
English: The clinical significance of these potential interactions is unknown.
Danish: Den kliniske relevans af disse potentielle interaktioner er ukendt.
English: The secondary objectives were to compare overall response rate (ORR) and overall survival (OS).
Danish: De sekundære mål var at sammenligne samlet responsrate (ORR) og samlet overlevelse (OS).
English: Your doctor may also prescribe other medicines to help control your side effects.
Danish: Din læge kan også ordinere andre lægemidler som hjælp til at kontrollere dine bivirkninger.
English: Swallow the capsules one at a time with water.
Danish: Synk kapslerne én ad gangen med vand.
English: Depending on the dose you were prescribed, the number of capsules to take are as follows:
Danish: Afhængig af den dosis, du har fået ordineret, er antallet af kapsler, der skal tages, som følger:
English: Embryo-foetal development studies were performed in rats and rabbits.
Danish: Embryo-føtale udviklingsstudier blev udført på rotter og kaniner.
English: The median time to first dose reduction was 43 days, and to first dose interruption was 33 days.
Danish: Mediantiden til første dosisreduktion var 43 dage og var til første dosisseponering 33 dage.
English: To help you remember your doses, write the date when you took your first dose in the space next to the capsules.
Danish: For at hjælpe dig med at huske dine doser, så skriv datoen hvor du tog din første dosis på pladsen ved siden af kapslerne.
English: Keep in mind that treatment with COMETRIQ may make you feel tired or weak.
Danish: Husk på, at behandling med COMETRIQ kan få dig til at føle dig træt eller svag.
English: PK assessments will be required for all subjects (both dose groups).
Danish: PK-vurderinger vil blive krævet for alle forsøgspersoner (begge doseringsgrupper).
English: It may help shrink tumours associated with this type of cancer.
Danish: Det hjælper til med at formindske tumorer, der er forbundet med denne type cancer.
English: Take your next dose at the normal time.
Danish: Tag din næste dosis på det normale tidspunkt.
English: The clinical relevance of the observed neoplastic lesions in rats is uncertain, but likely to be low.
Danish: Den kliniske relevans af de observerede neoplastiske læsioner hos rotter er uvis, men vil sandsynligvis være lille.
English: However, a trend in increased rate of SAEs has been observed in subjects aged 75 years and older.
Danish: En tendens til øget ratio af SAE'er er imidlertid blevet observeret hos forsøgspersoner i alderen 75 år og ældre.
English: Patients should be advised regarding oral hygiene practice.
Danish: Patienterne bør rådgives med henblik på praktisering af oral hygiejne.
English: There was no improvement in OS for the RET M918T negative and unknown subgroups.
Danish: Der var ingen forbedring i de RET-M918T-negative og ukendte undersgrupper.
English: Metabolic clinical laboratory parameters should be monitored at least weekly or as deemed clinically appropriate to assess any possible changing trends.
Danish: Metaboliske, kliniske laboratorieparametre bør monitoreres mindst ugentlig eller hvad der anses for klinisk passende for at vurdere mulige ændringstendenser.
English: Next generation sequencing of RET exons 10, 11, and 13-16 will be performed, which covers the vast majority of known RET mutations.
Danish: Næste generation af sekvensering af RETexoner 10, 11 og 13-16 vil blive udført, hvilket dækker det overvejende flertal af kendte RET-mutationer.
English: (1/55)c a Response = CR + PR b Disease Control Rate = SD+ ORR c Includes patients who were evaluable for response
Danish: (1/55)c a Respons = CR + PR b Sygdoms kontrolrate = SD + ORR c Omfatter patienter, der kunne evalueres for respons
English: COMETRIQ should be taken once a day.
Danish: COMETRIQ bør tages én gang om dagen.
English: Both men and women should be advised to seek advice and consider fertility preservation before treatment.
Danish: Både mænd og kvinder bør tilrådes at søge rådgivning og overveje fertilitetspræservering inden behandling.
English: Dose reductions are recommended for events that, if persistent, could become serious or intolerable.
Danish: Dosisreduktioner anbefales ved bivirkninger som, hvis de er vedvarende, kunne blive alvorlige eller intolerable.
English: If you take COMETRIQ whilst using oral contraceptives, the oral contraceptives may be ineffective.
Danish: Hvis du tager COMETRIQ samtidig med, at du anvender oral antikonception, er den orale antikonception måske ikke effektiv.
English: • A wound that does not heal.
Danish: • Et sår, der ikke heler op.
English: As unchanged contraceptive effect may not be guaranteed, an additional contraceptive method, such as a barrier method, is recommended.
Danish: Da uændret kontraceptiv virkning ikke kan garanteres, anbefales yderligere en antikonceptionsmetode, såsom en barrieremetode.
English: Avoid consuming grapefruit-containing products for as long as you are using this medicine, as it may increase the levels of COMETRIQ in your blood.
Danish: Undgå at indtage produkter, der indeholder grapefrugt, i den periode, hvor du tager dette lægemiddel, da det kan øge niveauerne af COMETRIQ i dit blod.
English: Each day, take all the capsules across the row.
Danish: Tag hver dag kapslerne på tværs af rækken.
English: 28 day pack containing:
Danish: 28-dages pakning indeholdende:
English: The effects of COMETRIQ in people younger than 18 years old are not known.
Danish: Virkningerne af COMETRIQ hos mennesker under 18 år er ikke kendte.
English: Therapy with COMETRIQ should be initiated by a physician experienced in the administration of anticancer medicinal products.
Danish: Behandling med COMETRIQ bør indledes af en læge med erfaring i administrationen af anticancer lægemidler.
English: Your doctor will determine if you need your dose adjusted, particularly during the first eight weeks of therapy with COMETRIQ.
Danish: Din læge vil afgøre, om du har behov for at få din dosis justeret, især de første otte uger af behandlingen med COMETRIQ.
English: There is no information on the precise food-effect when taken 1 hour after administration of cabozantinib.
Danish: Der er ingen oplysninger om den nøjagtige virkning af føde taget 1 time efter administration af cabozantinib.
English: BATCH NUMBER<, DONATION AND PRODUCT CODES> Lot
Danish: FREMSTILLERENS BATCHNUMMER <, DONATIONS- OG PRODUKTKODER> Lot
English: Record date of first dose.
Danish: Registrér datoen for den første dosis.
English: Mean clearance (CL/F) at steady-state in cancer patients was estimated to be 4.4 L/hr in a population PK analysis.
Danish: Mean clearance (CL/F) ved steady-state hos cancerpatienter blev estimeret til at være 4,4 l/t i en PK-analyse af populationen.
English: In case of such combination, INR values should be monitored.
Danish: INR værdier skal monitoreres i tilfælde af en sådan kombination.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Oral use.
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Oral brug.
English: Adverse reactions are listed in Table 1 according to MedDRA system organ class and frequency categories.
Danish: Bivirkninger er angivet i Tabel 1 i henhold til MedDRA systemets organklasse- og hyppighedskategorier.
English: It should be expected that a majority of patients treated with COMETRIQ will require one or more dose adjustments (reduction and/or interruption) due to toxicity.
Danish: Der bør forventes, at hos et flertal af patienter behandlet med COMETRIQ vil en eller flere dosisjusteringer (reduktion og/eller seponering) blive nødvendige på grund af toksicitet.
English: • Decrease in the levels of protein in your blood
Danish: • Fald i niveauerne af protein i dit blod