natgillin/translations-raw huggingface dataset:
• Et sår, der ikke heler op.
• A wound that does not heal.
Da uændret kontraceptiv virkning ikke kan garanteres, anbefales yderligere en antikonceptionsmetode, såsom en barrieremetode.
As unchanged contraceptive effect may not be guaranteed, an additional contraceptive method, such as a barrier method, is recommended.
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.
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.
Tag hver dag kapslerne på tværs af rækken.
Each day, take all the capsules across the row.
28-dages pakning indeholdende:
28 day pack containing:
Virkningerne af COMETRIQ hos mennesker under 18 år er ikke kendte.
The effects of COMETRIQ in people younger than 18 years old are not known.
Behandling med COMETRIQ bør indledes af en læge med erfaring i administrationen af anticancer lægemidler.
Therapy with COMETRIQ should be initiated by a physician experienced in the administration of anticancer medicinal products.
Din læge vil afgøre, om du har behov for at få din dosis justeret, især de første otte uger af behandlingen med COMETRIQ.
Your doctor will determine if you need your dose adjusted, particularly during the first eight weeks of therapy with COMETRIQ.
Der er ingen oplysninger om den nøjagtige virkning af føde taget 1 time efter administration af cabozantinib.
There is no information on the precise food-effect when taken 1 hour after administration of cabozantinib.
FREMSTILLERENS BATCHNUMMER <, DONATIONS- OG PRODUKTKODER> Lot
BATCH NUMBER<, DONATION AND PRODUCT CODES> Lot
Registrér datoen for den første dosis.
Record date of first dose.
Mean clearance (CL/F) ved steady-state hos cancerpatienter blev estimeret til at være 4,4 l/t i en PK-analyse af populationen.
Mean clearance (CL/F) at steady-state in cancer patients was estimated to be 4.4 L/hr in a population PK analysis.
INR værdier skal monitoreres i tilfælde af en sådan kombination.
In case of such combination, INR values should be monitored.
ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Oral brug.
METHOD AND ROUTE(S) OF ADMINISTRATION Oral use.
Bivirkninger er angivet i Tabel 1 i henhold til MedDRA systemets organklasse- og hyppighedskategorier.
Adverse reactions are listed in Table 1 according to MedDRA system organ class and frequency categories.
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.
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.
• Fald i niveauerne af protein i dit blod
• Decrease in the levels of protein in your blood
Der anbefales ikke nogen specifik dosisjustering ved brugen af cabozantinib til ældre mennesker (≥ 65 år).
No specific dose adjustment for the use of cabozantinib in older people (≥ 65 years) is recommended.
Inden for hver hyppighedsgruppering præsenteres bivirkningerne i rækkefølge af faldende alvorlighed.
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Hvis du oplever alvorlige bivirkninger, kan din læge beslutte at ændre din dosis eller stoppe behandlingen tidligere end oprindelig planlagt.
If you experience serious side effects, your doctor may decide to change your dose or stop treatment earlier than originally planned.
Baseret på den populationsfarmakokinetiske (PK) model, er fordelingsvolumen (V/F) cirka 349 liter (SE: ± 2,73 %).
Based on the populationpharmacokinetic (PK) model, the volume of distribution (V/F) is approximately 349 L (SE: ± 2.73%).
Det vides ikke, om cabozantinib og/eller dets metaboliter udskilles i humant mælk.
It is not known whether cabozantinib and/or its metabolites are excreted in human milk.
Median for progressionsfri overlevelse
Median Progression-Free Survival
Der bør derfor anbefales forsigtighed, når der køres eller betjenes maskiner.
Therefore, caution should be recommended when driving or operating machines.
På lægemidlets trykte indlægsseddel skal der anføres navn og adresse på den fremstiller, som er ansvarlig for frigivelsen af den pågældende batch
The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch
Denne effekt var ikke forbundet med en ændring i morfologien i hjertekurveformen eller nye rytmer.
This effect was not associated with a change in cardiac wave form morphology or new rhythms.
Tag alle kapsler i én række hver dag uden mad (patienten bør faste mindst 2 timer inden til og med 1 time efter at have taget kapslen).
Take all capsules in one row each day without food (patients should fast for at least 2 hours before through 1 hour after taking the capsules).
Alle patienter bør monitoreres for hypertension og om nødvendigt behandles med standard anti-hypertensiv terapi.
All patients should be monitored for hypertension and treated as needed with standard anti-hypertensive therapy.
Tal med din læge om, hvilke antikonceptionsmetoder er passende, mens du tager COMETRIQ.
Talk to your doctor about which methods of contraception are appropriate while you are taking COMETRIQ.
Du bør også fortælle din tandlæge, at du tager COMETRIQ.
You should also tell your dentist that you are taking COMETRIQ.
Patienter med både sporadiske og nedarvede former for MTC vil være egnede til studie.
Patients with both sporadic and hereditary forms of MTC will be eligible for the study.
Da de fleste bivirkninger kan forekomme tidligt i behandlingsforløbet, bør lægen nøje evaluere behandlingen af patienten i de første 8 uger af behandlingen for at afgøre, om dosismodifikationer er nødvendige.
As most events can occur early in the course of treatment, the physician should evaluate the patient closely during the first eight weeks of treatment to determine if dose modifications are warranted.
Bivirkninger forbundet med overdosering skal behandles symptomatisk.
Adverse reactions associated with overdose are to be treated symptomatically.
PVC/PE/PCTFE-Al blisterpakninger med folie bagside, forseglet på en sekundær, varmeforseglet kortpakning.
PVC/PE/PCTFE-Al blisters with foil backing, sealed into a secondary heat-sealed card packaging.
Udvis forsigtighed under kørsel eller ved brug af maskiner.
Use caution when driving or using machines.
Dette er fordi, at COMETRIQ kan påvirke den måde, visse andre lægemidler fungerer.
This is because COMETRIQ can affect the way some other medicines work.
Der er ingen specific behandling for overdosering med cabozantinib og mulige symptomer på overdosering er ikke blevet fastslået.
There is no specific treatment for cabozantinib overdose and possible symptoms of overdose have not been established.
COMETRIQ anbefales ikke til børn eller unge.
COMETRIQ is not recommended for children or adolescents.
• Hævelse i ansigtet og i andre dele af kroppen
• Swelling in the face and in other parts of the body
Sikkerheden og virkningen ved cabozantinib hos børn i alderen < 18 år er endnu ikke blevet fastslået.
The safety and efficacy of cabozantinib in children aged <18 years have not yet been established.
Disse patienter (n=16) udviste signifikant forlængelse af PFS (HR på 0,15) og en objektiv responsrate på 31 %.
These patients (n=16) showed significant prolongation of PFS (HR of 0.15) and an objective response rate of 31%.
Prøverne vil gennemgå grundig evaluering for RET- og RAS-mutationer.
Samples will undergo thorough evaluation for RET and RAS mutations.
Cabozantinib er yderst proteinbundet in vitro i humant plasma (≥ 99,7 %).
Cabozantinib is highly protein bound in vitro in human plasma (≥ 99.7%).
Der kan ikke gives specifikke anbefalinger for dosering.
No specific dosing recommendations can be made.
• Tab af koordination i dine muskler, skade på skeletmuskulatur
• Loss of coordination in your muscles, damage to skeletal muscles
Cabozantinibs karcinogene potentiale er blevet evalueret hos to arter: rasH2-transgene mus og Sprague-Dawley-rotter.
The carcinogenic potential of cabozantinib has been evaluated in two species: rasH2 transgenic mice and Sprague-Dawley rats.
Farmakokinetik i specielle patientpopulationer
Pharmacokinetics in special patient populations
Ingen cabozantinib-behandlede patienter havde en QTcF >500 ms.
No cabozantinib-treated subjects had a QTcF >500 ms.
Kvindelige partnere til mandlige patienter, der tager cabozantinib, skal også undgå graviditet.
Female partners of male patients taking cabozantinib must also avoid pregnancy.
Yderligere genetisk analyse viste, at en lille del af patienterne husede somatiske tumormutationer i HRAS, KRAS eller NRAS.
Further genetic analysis showed that a small proportion of patients harboured somatic tumour mutations in HRAS, KRAS, or NRAS.
Hvis patienten glemmer at tage en dosis, bør den manglende dosis ikke tages, hvis der er mindre end 12 timer til den næste dosis.
If a patient misses a dose, the missed dose should not be taken if it is less than 12 hours before the next dose.
Tryk kapslen gennem folien
Push capsule through foil
Der vil blive anmodet om en erstatningsprøve, hvis en oprindelig prøve mislykkes under PCR kvalitetseller Sanger sekvenseringstest.
A replacement sample will be requested if an original sample fails during the PCR quality or the Sanger sequencing tests.
Resultaterne vil blive anvendt til at evaluere eksponeringen over for cabozantinib ved 60 og 140 mg dosisniveauerne og til yderligere at karakterisere population PK-modellerne og eksponeringsrespons forhold for cabozantinib og mulige metabolitter i denne population.
Results will be used to evaluate the exposure to cabozantinib at the 60 and 140 mg dose levels and to further characterize the population PK models and exposure response relationships of cabozantinib and possible metabolites in this population.
Varighed af respons; median (95 % CI)
Duration of Response; Median (95% CI)
Studier af dyr har vist embryo-føtale og teratogene virkninger (se pkt.
Studies in animals have shown embryo-foetal and teratogenic effects (see section 5.3).
Forekomsten af visse alvorlige bivirkninger (såsom GI-fistel) kan være afhængige af den kumulative dosis og kan fremkomme på et senere trin i behandlingen.
The occurrence of some serious adverse reactions (like GI fistula) might be dependent on the cumulative dose and might present in a later stage of treatment.
Perforationer, fistler og intra-abdominale abscesser
Perforations, fistulas, and intra-abdominal abscesses
Hvis du eller din partner kan blive gravid, så anvend passende antikonception under behandlingen og mindst 4 måneder efter at behandlingen er afsluttet.
If you or your partner could become pregnant, use adequate contraception during treatment and for at least 4 months after treatment has finished.
Behandlingen bør fortsættes, indtil patienten ikke længere har klinisk fordel af behandlingen, eller indtil der forekommer uacceptabel toksicitet.
Treatment should continue until the patient is no longer clinically benefiting from therapy or until unacceptable toxicity occurs.
Seponeringer af dosering anbefales til kontrol af CTCAE grad 3 eller højere toksiciteter eller uudholdelige grad 2 toksiciteter.
Dose interruptions are recommended for management of CTCAE grade 3 or greater toxicities or intolerable grade 2 toxicities.
Dette kunne betyde, at din læge er nødt til at ændre den dosis, du tager.
This could mean that your doctor needs to change the dose(s) that you take.
Tabel 2: Resumé af nøgle virkningsfund
Table 2: Summary of key efficacy findings
CEA responsa
CEA Responsea
Du har måske behov for behandling for dem, eller din læge kan beslutte at ændre din dosis af COMETRIQ eller helt stoppe behandlingen.
You may need treatment for them, or your doctor may decide to change your dose of COMETRIQ, or stop treatment altogether.
Da oral antikonception muligvis ikke kan betragtes som ”effektive metoder for antikonception”, bør de anvendes sammen med en anden metode, såsom en barrieremetode (se pkt.
Because oral contraceptives might possibly not be considered as “effective methods of contraception,” they should be used together with another method, such as a barrier method (see section 4.5).
Almindelig (≥1/100 til <1/10)
Common (1/100 to <1/10)
RET-mutationsstatus
RET mutation status
Virkning af cabozantinib på andre lægemidler
Effect of cabozantinib on other medicinal products
For patienter, hos hvem Rearranged during Transfection (RET) mutationsstatus ikke er kendt eller negativ, bør en mulig nedsat virkning af behandlingen tages i betragtning, inden der tages beslutning om individuel behandling (se vigtige oplysninger i pkt.
For patients in whom Rearranged during Transfection (RET) mutation status is not known or is negative, a possible lower benefit should be taken into account before individual treatment decision (see important information in sections 4.4 and 5.1).
• Opkastning eller hosten blod op, hvilket kan være klart rødt eller ligne kaffegrums.
• Vomiting or coughing up blood, which may be bright red or look like coffee grounds.
• Abnorm hårvækst
• Abnormal hair growth
Hvis din næste dosis skal tages inden mindre end 12 timer, så lad være at tage den dosis, som du har glemt.
If your next dose is due in less than 12 hours then do not take the dose that you have missed.
Hvis du har taget flere COMETRIQ, end du har fået besked på, så kontakt en læge eller tag på hospitalet med kapslerne og denne indlægsseddel med det samme.
If you have taken more COMETRIQ than you have been instructed to, talk to a doctor or go to the hospital with the capsules and this leaflet straight away.
Hvis der stadig er 12 timer eller mere inden din næste dosis, så tag den glemte dosis lige så snart, du husker det.
If there are still 12 hours or more before your next dose is due then take the missed dose as soon as you remember.
• Ændringer i blodtest, der bruges til at overvåge den almene helbredstilstand og leveren, lave niveauer af elektrolytter (som magnesium, calcium eller kalium)
• Changes in blood tests used to monitor general health and the liver, low levels of electrolytes (like magnesium, calcium or potassium)
Ingen data er tilgængelige for at kunne bestemme en forskel i farmakokinetikken baseret på race.
No data are available to determine a difference in PK based on race.
NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Ipsen Pharma
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Ipsen Pharma
Flere oplysninger på blisterkortene omfatter, hvor mange kapsler du skal tage og hvor mange kapsler ialt, der er i hvert blisterkort, er beskrevet nedenfor under pkt.
More information on the blister cards including how many capsules you will take and how many capsules there are in total in each blister card are described below in section 6.
Hyppigheder er baseret på alle grader og defineret som: Meget almindelig (≥1/10), almindelig (≥1/100 til <1/10); ikke almindelig (≥1/1.000 til <1/100) , ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
Frequencies are based on all grades and defined as: very common (≥1/10), common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100), not known (cannot be estimated from the available data).
• Ændringer i testresultater, der måler blodkoagulation eller blodlegemer
• Changes in test results that measure blood clotting or blood cells
Tal med din læge INDEN du tager COMETRIQ hvis du eller din partner overvejer eller planlægger at få en baby efter at din behandling er afsluttet.
Talk to your doctor BEFORE taking COMETRIQ if you or your partner are considering or planning to have a baby after your treatment has finished.
Disse kan være tegn på en perforation af mave-tarm-kanalen, et hul, der udvikler sig i din mave eller tarm, som kunne være livstruende.
These may be signs of a gastrointestinal perforation, a hole that develops in your stomach or intestine that could be life-threatening.
Cabozantinib bør ikke anvendes under graviditet, medmindre kvindens kliniske tilstand kræver behandling med cabozantinib.
Cabozantinib should not be used during pregnancy unless the clinical condition of the woman requires treatment with cabozantinib.
• Øgning i niveauet af bilirubin i dit blod (hvilket kan resultere i gulsot/gulfarvning af hud og øjne)
• Increase in the level of bilirubin in your blood (which may result in jaundice/yellow skin or eyes)
Kontakt lægen eller apotekspersonalet, før du tager COMETRIQ, hvis du:
Talk to your doctor or pharmacist before taking COMETRIQ if you:
P-glykoprotein-substrater
P-glycoprotein substrates
Effektive antikonceptionsmetoder bør anvendes af mandlige og kvindelige patienter og deres partnere under behandlingen og i mindst 4 måneder efter fuldførelsen af behandlingen.
Effective methods of contraception should be used by male and female patients and their partners during therapy, and for at least 4 months after completing therapy.
Et primært mål var at sammenligne progressions-fri overlevelse (PFS) hos patienter, der fik cabozantinib versus patienter, der fik placebo.
The primary objective was to compare progression-free survival (PFS) in patients receiving cabozantinib versus patients receiving placebo.
De resulterende DNA-prøver vil blive evalueret for kvalitet ved en PCR-baseret forstærkningstest og ved Sanger-sekvensering for RET-M918T.
The resulting DNA samples will be evaluated for quality by a PCR-based amplification test, and by Sanger sequencing for RET M918T.
• Angst, depression, konfusion
• Anxiety, depression, confusion
Virkningen af cabozantinib på farmakokinetikken for antikonceptionssteroider er ikke blevet undersøgt.
The effect of cabozantinib on the pharmacokinetics of contraceptive steroids has not been investigated.
Figur 3: Kaplan-Meier analyse af OS blandt forsøgspersoner med en RET-M918T-mutation
Figure 3: Kaplan-Meier Analysis of OS Among Subjects with a RET M918T Mutation
Kapslen indeholder et elfenbenshvidt til hvidt pulver.
The capsule contains an off-white to white powder.
Der findes ingen studier med gravide kvinder, der bruger cabozantinib.
There are no studies in pregnant women using cabozantinib.
EVENTUELLE ANDRE SÆRLIGE ADVARSLER Der henvises til de individuelle blisterkort for dispenseringsinstruktioner.
OTHER SPECIAL WARNING(S), IF NECESSARY Refer to individual blister cards for dispensing instructions.
Cabozantinib påvirker i mindre grad evnen til at føre motorkøretøj og betjene maskiner.
Cabozantinib has a minor influence on the ability to drive and use machines.
Cabonazinib bør genstartes med en lavere dosis, når PPES er reduceret til grad 1.
Cabozantinib should be restarted with a lower dose when PPES has been resolved to grade 1.
• Hypertension (øgning i blodtryk)
• Hypertension (increase in blood pressure)
Hvert blisterkort har nok kapsler til til at vare syv dage (én uge).
Each blister card has enough capsules to last for seven days (one week).
Sandsynlighed
Probability
Tag ikke COMETRIQ • hvis du er allergisk over for cabozantinib eller et af de øvrige indholdsstoffer (angivet i pkt.
Do not take COMETRIQ - if you are allergic to cabozantinib or any of the other ingredients of this medicine (listed in section 6).
Hvis du får bivirkninger, vil din læge måske bede dig om at tage COMETRIQ i en lavere dosis.
If you get side effects, your doctor may tell you to take COMETRIQ at a lower dose.
Kvinder, der tager COMETRIQ, bør ikke amme under behandlingen og i mindst 4 måneder efter, at behandlingen er afsluttet, da cabozantinib og/eller dets metaboliter kan udskilles i brystmælk og være skadeligt for dit barn.
Women taking COMETRIQ should not breast feed during treatment and for at least 4 months after treatment has finished, as cabozantinib and/or its metabolites may be excreted in breast milk and be harmful to your child.
• 60 mg (3 grå 20 mg kapsler) Din læge vil afgøre, hvad der er den rette dosis for dig.
• 60 mg (3 grey 20 mg capsules) Your doctor will decide on the right dose for you.
Dine kapsler vil komme i et blisterkort organiseret efter den ordinerede dosis.
Your capsules will come in a blister card organised by prescribed dose.
Der er begrænsede data for patienter med nedsat hjertefunktion.
There is limited data in patients with cardiac impairment.
Sygdoms kontrolrate b (95 % CI) Calcitonin responsa
Disease Control Rate b (95% CI) Calcitonin Responsea
Plasmakoncentrations-tids-profiler viser endnu en absorptionstop cirka 24 timer efter administration, hvilket antyder, at cabozantinib kan gennemgå enterohepatisk recirkulation.
Plasma-concentration time profiles show a second absorption peak approximately 24 hours after administration, which suggests that cabozantinib may undergo enterohepatic recirculation.
Baseret på ikke-kliniske sikkerhedsfund, kan mandlig og kvindelig fertilitet blive kompromitteret af behandling med cabozantinib (se pkt.
Based on non-clinical safety findings, male and female fertility may be compromised by treatment with cabozantinib (see section 5.3).
• Atrieflimmer (hurtige og uregelmæssige hjerteslag)
• Atrial fibrillation (a fast and erratic heartbeat)
• Svampeinfektioner, der kan være i huden, munden eller kønsorganerne
• Fungal infection that can be in the skin, mouth, or genitals
Tooghalvfems procent af patienterne i cabozantinib armen havde en forudgående thyroidektomi, og 89 % tog thyroideahormoner forud for den første dosis.
Ninety-two percent of patients on the cabozantinib arm had a prior thyroidectomy, and 89% were taking thyroid hormones prior to first dose.
COMETRIQ kapsler er pakket på blisterkort organiseret efter den ordinerede dosis.
COMETRIQ capsules are packaged in blister cards organised by prescribed dose.
Brug ikke lægemidlet efter den udløbsdato, der står på blisterkortet efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
Do not use this medicine after the expiry date which is stated on the blister card after EXP.
• Ændringer i hårfarve (lysner), hårtab
• Hair colour changes (lightening), hair loss
Plasma terminal halveringstid for cabozantinib i studier med enkeltdosis hos raske frivillige er cirka 120 timer.
The plasma terminal half-life of cabozantinib in single dose studies in healthy volunteers is approximately 120 hours.
Wingate Industrial Park Westhoughton
Wingates Industrial Park Westhoughton
Derudover vil prøver blive evalueret for mutationer i RAS-gen hotspots (HRAS-, KRAS- og NRAS-gener).
In addition, samples will be evaluated for mutations in RAS gene hotspots (HRAS, KRAS, and NRAS genes).
• Tab af opmærksomhed, bevidsthedstab, ændringer i tale, delirium, abnorme drømme
• Loss of attention, loss of consciousness, changes in speech, delirium, abnormal dreams
Figur 2: Kaplan-Meier kurve for samlet overlevelse
Figure 2: Kaplan-Meier curve of overall survival
De objektive responsrater målt i disse undergrupper var generelt konsistente med PFS-resultaterne, med RET-mutationspositive, -negative og ukendte undergrupper udvisende tumorresponsrater på henholdsvis 32 %, 22 % og 25 %.
The objective response rates measured in these subgroups were generally consistent with the PFS results, with the RET mutation positive, negative, and unknown subgroups showing tumour response rates of 32%, 22%, and 25%, respectively.
Friske tumorprøver til tumorgenetisk analyse fra det seneste metastatiske sted bør indsamles hos patienter tilmeldt det dosissammenlignede studie.
Fresh tumour samples for tumour genetic analysis from the most recent metastatic site in patients enrolled in the dose-comparison study should be collected.
Hos patienter med let eller moderat nedsat leverfunktion er den anbefalede dosis cabozantinib 60 mg én gang daglig.
In patients with mild or moderate hepatic impairment the recommended dose of cabozantinib is 60 mg once daily.
Du skal også anvende en barriere antikonception (f.eks. kondom eller pessar), mens du tager COMETRIQ og i mindst 4 måneder efter, at behandlingen er afsluttet.
You should also use a barrier contraceptive (e.g. condom or diaphragm) whilst taking COMETRIQ and for at least 4 months after treatment has finished.
Hver række på blisterkortet indeholder den daglige dosis.
Each row of the blister card contains the daily dose.
• Ophør af menstruation, vaginalblødning
• Stopping menstruation, vaginal bleeding