natgillin/translations-raw huggingface dataset:
Når Erbitux anvendes alene eller sammen med andre lægemidler mod kræft, fortsættes med Erbitux, så længe patienten responderer.
When it is used on its own or with other anticancer medicines, Erbitux is continued for as long as the patient responds.
Erbitux anvendes til patienter, hvis kræftceller har et protein på overfladen, som kaldes epidermal vækstfaktorreceptor (EGFR), og som indeholder en ”vildtype” (ikke-muteret) udgave af en gengruppe kaldet ”RAS”.
Erbitux is used in patients whose tumour cells have a protein on their surface called epidermal growth factor receptor (EGFR) and contain ‘wild-type' (non-mutated) versions of a family of genes called ‘RAS'.
Erbitux er en opløsning til infusion (drop i en vene), som indeholder det aktive stof cetuximab.
Erbitux is a solution for infusion (drip into a vein) that contains the active substance cetuximab.
Når Erbitux anvendes sammen med strålebehandling, begyndes behandlingen med Erbitux en uge før påbegyndelse af strålebehandling og fortsættes, indtil strålebehandlingen er afsluttet.
When it is used with radiotherapy, Erbitux is started one week before the radiotherapy starts and continued until the radiotherapy has finished.
Når RAS-gener (såsom KRAS) muterer, kan de stimulere tumorvæksten uden først at være blevet aktiveret af EGFR, så her kan det ikke forventes, at Erbitux er til nogen stor hjælp.
When RAS genes (such as KRAS) are mutated they can stimulate the tumour cells to grow without being switched on by EGFR, so Erbitux would not be expected to be of much help.
Til behandling af tilbagevendende (når sygdommen kommer tilbage efter tidligere behandling) eller metastatisk kræft anvendes Erbitux med en ”platinbaseret” lægemiddelkombination mod kræft (inklusive lægemidler som cisplatin eller carboplatin).
In cancer that is recurrent (when it has come back after previous treatment) or metastatic, Erbitux is used with a ‘platinum-based' anticancer medicine combination (including medicines such as cisplatin or carboplatin).
Erbitux anvendes også til behandling af ‘pladecelle-'kræft i hoved og hals.
Erbitux is also used to treat ‘squamous cell' cancers of the head and neck.
Cetuximab er udviklet til at binde sig til EGFR, som findes på overfladen af visse kræftceller.
Cetuximab has been designed to attach to EGFR, which can be found on the surface of some tumour cells.
Erbitux må ikke anvendes sammen med kemoterapi indeholdende oxaliplatin til metastatisk colorectal cancer hos patienter med muteret RAS eller patienter med en ukendt RAS-status.
Erbitux must not be used with oxaliplatin-containing chemotherapy for metastatic colorectal cancer in patients with mutated RAS or for whom RAS status is unknown.
En af undersøgelserne så desuden på de individuelle resultater hos de patienter, hvis tumorer indeholdt vildtypeformer af alle RAS-gener, og fra patienter med muterede former af et hvilket som helst RAS-gen.
One of the studies also looked at the results separately in patients whose tumours carried wild-type forms of all RAS genes and patients with mutated forms of any RAS gene.
• Den første undersøgelse omfattede 424 patienter med lokalt fremskreden kræft, hvor man så på virkningen af Erbitux i tillæg til strålebehandling.
• the first study involved 424 patients with locally advanced cancer, looking at the effects of adding Erbitux to radiotherapy;
• Den første undersøgelse af patienter, som havde fået kemoterapi før, så ikke på RAS-mutationer, men i de to andre undersøgelser levede patienterne med vildtype-KRAS i tumorerne længere, uden at sygdommen blev værre, når Erbitux blev føjet til deres behandling.
• the first study in patients who had taken chemotherapy before did not look at RAS mutations, but in the other two studies, patients with wild-type KRAS in their tumours lived for longer without their disease getting worse when Erbitux was added to their treatment.
Hvilken risiko er der forbundet med Erbitux?
What is the risk associated with Erbitux?
• Den anden undersøgelse omfattede 442 patienter med tilbagevendende eller metastatisk kræft, hvor man så på virkningen af Erbitux i tillæg til en platinbaseret lægemiddelkombination mod kræft.
• the second study involved 442 patients with recurrent or metastatic cancer, looking at the effects of adding Erbitux to a platinum-based anticancer medicine combination.
I den tredje undersøgelse overlevede patienterne med vildtype-KRAS dog som helhed i 16,3 måneder, når Erbitux blev anvendt i tillæg til en anden behandling med oxaliplatin, der svarede til FOLFOX, sammenlignet med 18,2 måneder, når behandlingen med oxaliplatin anvendtes alene.
However, in the third study, patients with wild-type KRAS only survived overall for 16.3 months when Erbitux was added to the another oxaliplatin-based treatment similar to FOLFOX, compared with 18.2 months when the oxaliplatin-based treatment was used alone.
I de fleste af undersøgelserne så man på de individuelle resultater hos de patienter, hvis tumorer indeholdt KRAS-vildtypen (et af RAS-gentyperne), og patienter, hvis tumorer indeholdt muteret KRAS.
Most of the studies looked at the results separately in patients whose tumours had wildtype KRAS (one of the types of RAS genes) and patients whose tumours had mutated KRAS.
Den fuldstændige liste over indberettede bivirkninger ved Erbitux fremgår af indlægssedlen.
For the full list of all side effects reported with Erbitux, see the package leaflet.
Ved metastatisk kræft i tyktarm eller endetarm blev Erbitux undersøgt i seks hovedundersøgelser:
For metastatic cancer of the colon or rectum, Erbitux was studied in six main studies:
Erbitux anvendes til behandling af metastatisk kræft i colon eller rectum (tyktarmen/endetarmen).
Erbitux is used to treat metastatic cancer of the colon or rectum (large intestine).
Hvorfor blev Erbitux godkendt?
Why has Erbitux been approved?
• sammen med behandlingen FOLFOX4, der indeholder oxaliplatin, til ikke tidligere behandlede patienter
• together with the oxaliplatin-containing treatment FOLFOX in patients who have not been treated before;
Ved tilbagevendende eller metastatisk kræft i hals og hoved var overlevelsen længere, når Erbitux blev føjet til en platinbaseret lægemiddelkombination mod kræft (10,1 måneder sammenlignet med 7,4 måneder i gennemsnit).
In recurrent or metastatic head and neck cancer, survival was longer when Erbitux was added to a platinum-based anticancer medicine combination (10.1 months compared with 7.4 months, on average).
Ved hoved-hals-kræft blev Erbitux undersøgt i to hovedundersøgelser:
For cancers of the head and neck, Erbitux was investigated in two main studies:
I undersøgelserne af kræft i tyktarm og endetarm viste Erbitux sig generelt at forlænge patienternes levetid, uden at sygdommen blev værre:
In the studies of cancer of the colon or rectum, Erbitux was shown overall to increase the time patients lived without their cancer getting worse or how long they survived:
Hvad er Erbitux?
What is Erbitux?
Patienter, som ikke havde responderet på hverken oxaliplatin- eller irinotecanbehandling, levede i gennemsnitligt 3,6 måneder, uden at sygdommen blev værre, når de fik Erbitux, sammenlignet med 1,9 måneder hos dem, der modtog ”bedst mulige støtte og pleje” alene (behandling af symptomer, men ikke selve kræftsygdommen).
Patients who had failed both oxaliplatin and irinotecan treatment lived for an average of 3.6 months without their disease getting worse with Erbitux, compared with 1.9 months in those receiving best supportive care alone (the treatment of symptoms but not the cancer itself).
Hos patienter, der fik Erbitux i tillæg til kemoterapi med oxaliplatin (FOLFOX) levede patienterne med vildtype-RAS længere, uden at sygdommen blev værre, sammenlignet med patienter, der fik FOLFOX alene (12,0 måneder sammenlignet med 5,8 måneder i gennemsnit).
In patients receiving Erbitux in combination with oxaliplatin-containing chemotherapy (FOLFOX) patients with wild-type RAS lived for longer without their disease getting worse compared with patients on FOLFOX alone (12.0 months compared with 5.8 months, on average).
• Hos patienter, som ikke havde fået kemoterapi før, levede patienter med vildtype-KRAS i tumorerne længere, uden at sygdommen blev værre, når de fik Erbitux i tillæg til kemoterapi med irinotecan (9,9 måneder sammenlignet med 8,4 måneder i gennemsnit).
• in patients who had not received chemotherapy before, patients who had wild-type KRAS in their tumours lived for longer without their disease getting worse when they received Erbitux in addition to chemotherapy including irinotecan (9.9 months compared with 8.4 months, on average).
Ved lokalt fremskreden hoved-hals-kræft levede patienterne længere, uden at sygdommen blev værre, når Erbitux blev føjet til strålebehandling (24,4 måneder sammenlignet med 14,9 måneder i gennemsnit).
In locally advanced head and neck cancers, the patients lived for longer without their disease getting worse when Erbitux was added to radiotherapy (24.4 months compared with 14.9 months, on average).
Patienter, der ikke havde responderet på behandling med oxaliplatin, levede i gennemsnitligt 4,0 måneder, uden at sygdommen blev værre, når de fik Erbitux plus irinotecan, sammenlignet med 2,6 måneder hos dem, der fik irinotecan alene.
Patients who had failed oxaliplatin treatment lived for an average of 4.0 months without their disease getting worse with Erbitux plus irinotecan, compared with 2.6 months in those receiving irinotecan alone.
Hvordan blev Erbitux undersøgt?
How has Erbitux been studied?
Hvad anvendes Erbitux til?
What is Erbitux used for?
Ved at binde sig til EGFR forhindrer cetuximab dette i at ske i kræftcellerne og er dermed med til at standse cellernes vækst.
EGFR is involved in switching on genes called RAS that are involved in the growth of cells; by attaching to EGFR, cetuximab prevents this from happening in the tumour cells and helps stop them growing.
Hvilken fordel viser undersøgelserne, at der er ved Erbitux?
What benefit has Erbitux shown during the studies?
Hvordan anvendes Erbitux?
How is Erbitux used?
En tredje undersøgelse så også på virkningen af Erbitux i tillæg til to behandlingskombinationer, der indeholdt oxaliplatin (hvoraf den ene svarede til FOLFOX) hos 1 630 patienter.
• two studies involved 1,535 patients who had not received chemotherapy before, looking at the effects of adding Erbitux to a treatment combination containing either irinotecan or oxaliplatin (FOLFOX); a third study looked also at the effects of adding Erbitux to two treatment combinations containing oxaliplatin (one of which was similar to FOLFOX) in 1,630 patients.
Hvordan virker Erbitux?
How does Erbitux work?
Bilag I Fortegnelse over lægemidler og lægemiddelform
Annex I List of medicinal products and presentations
Kapsel, blød
Capsule, Soft
Orale dråber, opløsning Oral anvendelse
Oral Drops, Solution Oral Use
Pulver og solvens til injektionsvæske, opløsning
Powder And Solvent For Solution For Injection
Valproinsyre 43.38mg/Ml
Valproic Acid 43.38mg/Ml
ácido Valpróico Generis Valproinsyre 400mg/4 Ml
ácido Valpróico Generis Valproic Acid 400mg/4 Ml
Natriumvalproat Bp 200mg
Sodium Valproate Bp 200mg
Østrig sanofi-aventis GmbH Depakine Chrono
Austria sanofi-aventis GmbH Depakine Chrono
Tablet, filmovertrukket Oral anvendelse
Modified-Release Tablet Oral Use
Tablet, overtrukket
Coated Tablet
Sodium Valproate Ivax Natriumvalproat 200mg/5 Ml
Sodium Valproate Ivax Sodium Valproate 200mg/5 Ml
Rektal anvendelse
Rectal Use
Seminatriumvalporat 269.1mg Tablet
Valproate Semisodium 269.1mg Tablet
Natriumvalproat Aristo Natriumvalproat 300mg G
Natriumvalproat Aristo Sodium Valproate 300mg G
Østrig sanofi-aventis GmbH Depakine
Austria sanofi-aventis GmbH Depakine
Valproinsyre 50mg/Ml
Valproic Acid 50mg/Ml
Den Tjekkiske republic G.L.
United Kingdom G.L.
Valpromid 300mg Tablet
Valpromide 300mg Tablet
Koncentrat til Injektionsvæske, opløsning/Infusionsvæs ke, opløsning
Concentrate For Solution For Injection/Infusion
Seminatriumvalporat 538.2mg Tablet
Valproate Semisodium 538.2mg Tablet
Natriumvalproat 300mg Suppositorie
Sodium Valproate 300mg Suppository
Depakine Chrono 500 Valproinsyre 145.14mg Tablet, Natriumvalproat
Depakine Chrono 500 Valproic Acid 145.14mg Tablet, Sodium
Valproinsyre 72.61mg Brev, Natriumvalproat 166.76mg Brev
Valproic Acid 72.61mg Sachet, Sodium Valproate 166.76mg Sachet
Valproinsyre 87mg G, Natriumvalproat 200mg Tablet
Valproic Acid 87mg G, Sodium Valproate 200mg Tablet
Sodium Valproate Teva Natriumvalproat 200mg Tablet
Sodium Valproate Teva Sodium Valproate 200mg Tablet
Valproinsyre 217.75mg Brev, Natriumvalproat 500.06mg Brev
Valproic Acid 217.75mg Sachet, Sodium Valproate 500.06mg Sachet
Valproinsyre 29.03mg Brev, Natriumvalproat 66.66mg Brev
Valproic Acid 29.03mg Sachet, Sodium Valproate 66.66mg Sachet
ácido Valproico G.E.S Natriumvalproat 400mg hætteglas
ácido Valproico G.E.S Sodium Valproate 400mg Vial
Den Tjekkiske republik Desitin Arzneimittel Gmbh
United Kingdom Desitin Arzneimittel Gmbh
Depotkapsel, hård
Modified-Release Capsule, Hard
Valproinsyre 145mg G, Natriumvalproat 333mg G
Valproic Acid 145mg G, Sodium Valproate 333mg G
Valproate Retard Eg Valproinsyre 87mg Tablet, Natriumvalproat
Valproate Retard Eg Valproic Acid 87mg Tablet, Sodium
Valproinsyre 290.27mg Brev, Natriumvalproat 666.6mg Brev
Valproic Acid 290.27mg Sachet, Sodium Valproate 666.6mg Sachet
Sodium Valproate Teva Natriumvalproat 500mg Tablet
Sodium Valproate Teva Sodium Valproate 500mg Tablet
Valproate Retard Mylan Natriumvalproat 300mg Tablet
Valproate Retard Mylan Sodium Valproate 300mg Tablet
200mg Tablet
Valproate 200mg Tablet
Valproat Neuraxpharm Natriumvalproat 60mg/Ml
Valproat Neuraxpharm Sodium Valproate 60mg/Ml
333.3mg brev
333mg G
Valproate Retard Mylan Natriumvalproat 500mg Tablet
Valproate Retard Mylan Sodium Valproate 500mg Tablet
Østrig sanofi-aventis GmbH Depakine Chronosphere Valproinsyre 145.14mg Brev, Natriumvalproat
Austria sanofi-aventis GmbH Depakine Chronosphere Valproic Acid 145.14mg Sachet, Sodium
333mg Tablet
Valproate 333mg Tablet
Espa-Valept Retard Natriumvalproat 300mg Tablet
Espa-Valept Retard Sodium Valproate 300mg Tablet
Østrig sanofi-aventis GmbH Depakine Chronosphere Valproinsyre 72.61mg Brev, Natriumvalproat
Austria sanofi-aventis GmbH Depakine Chronosphere Valproic Acid 72.61mg Sachet, Sodium
Valproinsyre 150mg kapsel
Sodium Valproate 150mg Capsule
Sanofi-Aventis Aebe Depakine Chronosphere Valproinsyre 29.03mg Brev, Natriumvalproat
Sanofi-Aventis Aebe Depakine Chronosphere Valproic Acid 29.03mg Sachet, Sodium
Valproate Retard Eg Valproinsyre 145mg Tablet, Natriumvalproat
Valproate Retard Eg Valproic Acid 145mg Tablet, Sodium
Depakine Chronosphere Valproinsyre 217.75mg Brev, Natriumvalproat
Depakine Chronosphere Valproic Acid 217.75mg Sachet, Sodium
Østrig sanofi-aventis GmbH Depakine Chronosphere Valproinsyre 14.51mg Brev, Natriumvalproat
Austria sanofi-aventis GmbH Depakine Chronosphere Valproic Acid 14.51mg Sachet, Sodium
Sanofi-Aventis Aebe Depakine Chronosphere Valproinsyre 72.61mg Brev, Natriumvalproat
Sanofi-Aventis Aebe Depakine Chronosphere Valproic Acid 72.61mg Sachet, Sodium
Injektionsvæske, opløsning/Infusionsvæs ke, opløsning
Solution For Injection/Infusion
Valproat Neuraxpharm Natriumvalproat 300mg/Ml
Valproat Neuraxpharm Sodium Valproate 300mg/Ml
Valproinsyre 145.14mg Brev, Natriumvalproat 333.3mg Brev
Valproic Acid 145.14mg Sachet, Sodium Valproate 333.3mg Sachet
Sanofi-Aventis Aebe Depakine Chronosphere Valproinsyre 290.27mg Brev, Natriumvalproat
Sanofi-Aventis Aebe Depakine Chronosphere Valproic Acid 290.27mg Sachet, Sodium
ácido Valpróico Generis Valproinsyre 87mg Tablet, Natriumvalproat 199.8mg Tablet
ácido Valpróico Generis Valproic Acid 87mg Tablet, Sodium
Aventis Pharma Ltd Epilim Chronosphere Valproinsyre 145.14mg Brev, Natriumvalproat
United Kingdom Aventis Pharma Ltd Epilim Chronosphere Valproic Acid 145.14mg Sachet, Sodium
Aventis Pharma Ltd Epilim Chronosphere Valproinsyre 217.75mg Brev, Natriumvalproat
United Kingdom Aventis Pharma Ltd Epilim Chronosphere Valproic Acid 217.75mg Sachet, Sodium
Valproat 1 A Pharma Natriumvalproat 150mg Tablet
Valproat 1 A Pharma Sodium Valproate 150mg Tablet
Depakine Chrono 300 Valproinsyre 87mg Tablet, Natriumvalproat 200mg Tablet
Depakine Chrono 300 Valproic Acid 87mg Tablet, Sodium
Aventis Pharma Ltd Epilim Chronosphere Valproinsyre 72.61mg Brev, Natriumvalproat
United Kingdom Aventis Pharma Ltd Epilim Chronosphere Valproic Acid 72.61mg Sachet, Sodium
Natriumvalproat 300mg Kapsel
Sodium Valproate 300mg Capsule
Aventis Pharma Ltd Epilim Chronosphere Valproinsyre 29.03mg Brev, Natriumvalproat
United Kingdom Aventis Pharma Ltd Epilim Chronosphere Valproic Acid 29.03mg Sachet, Sodium
ácido Valpróico Sandoz Natriumvalproat 300mg Tablet
ácido Valpróico Sandoz Sodium Valproate 300mg Tablet
Aventis Pharma Ltd Epilim Chronosphere Valproinsyre 14.51mg Brev, Natriumvalproat
United Kingdom Aventis Pharma Ltd Epilim Chronosphere Valproic Acid 14.51mg Sachet, Sodium
ácido Valpróico Sandoz Natriumvalproat 500mg Tablet
ácido Valpróico Sandoz Sodium Valproate 500mg Tablet
Acido Valproico Sandoz Natriumvalproat 300mg Tablet
Acido Valproico Sandoz Sodium Valproate 300mg Tablet
Epilim Chronosphere Valproinsyre 29.03mg Brev, Natriumvalproat
Epilim Chronosphere Valproic Acid 29.03mg Sachet, Sodium
Aventis Pharma Ltd Epilim Chronosphere Valproinsyre 290.27mg Brev, Natriumvalproat
United Kingdom Aventis Pharma Ltd Epilim Chronosphere Valproic Acid 290.27mg Sachet, Sodium
Acido Valproico Sandoz Natriumvalproat 500mg Tablet
Acido Valproico Sandoz Sodium Valproate 500mg Tablet
Valproat Neuraxpharm Natriumvalproat 150mg Enhed
Valproat Neuraxpharm Sodium Valproate 150mg Units
Natriumvalproat 500mg Kapsel
Sodium Valproate 500mg Capsule
Depakine Chronosphere Valproinsyre 72.61mg Brev, Natriumvalproat
Depakine Chronosphere Valproic Acid 72.61mg Sachet, Sodium
Depakine Chronosphere Valproinsyre 290.27mg Brev, Natriumvalproat
Depakine Chronosphere Valproic Acid 290.27mg Sachet, Sodium
Natriumvalproat 1000mg Beholder
Sodium Valproate 1000mg Container
Valproat Chrono Sandoz Natriumvalproat 300mg Tablet
Valproat Chrono Sandoz Sodium Valproate 300mg Tablet
Valproat Ratiopharm Valproinsyre 145mg G, Natriumvalproat 333mg
Valproat Ratiopharm Valproic Acid 145mg G, Sodium Valproate
Valproat 1 A Pharma Natriumvalproat 300mg Tablet
Valproat 1 A Pharma Sodium Valproate 300mg Tablet
Valproát Chrono Sandoz Natriumvalproat 300mg Tablet
Valproát Chrono Sandoz Sodium Valproate 300mg Tablet
Natriumvalproat 200mg Enterotablet
Sodium Valproate 200mg
Valproat Chrono Sandoz Natriumvalproat 500mg Tablet
Valproat Chrono Sandoz Sodium Valproate 500mg Tablet
Valproát Chrono Sandoz Natriumvalproat 500mg Tablet
Valproát Chrono Sandoz Sodium Valproate 500mg Tablet
Depakine Chronosphere Valproinsyre 14.51mg Brev, Natriumvalproat
Depakine Chronosphere Valproic Acid 14.51mg Sachet, Sodium
Valproat 1 A Pharma Natriumvalproat 600mg Tablet
Valproat 1 A Pharma Sodium Valproate 600mg Tablet
Depakine Chronosphere Valproinsyre 29.03mg Brev, Natriumvalproat
Depakine Chronosphere Valproic Acid 29.03mg Sachet, Sodium
Valproat Neuraxpharm Natriumvalproat 600mg Enhed
Valproat Neuraxpharm Sodium Valproate 600mg Units
Epilim Chronosphere Valproinsyre 72.61mg Brev, Natriumvalproat
Epilim Chronosphere Valproic Acid 72.61mg Sachet, Sodium
Valproat 1 A Pharma Natriumvalproat 500mg Tablet
Valproat 1 A Pharma Sodium Valproate 500mg Tablet
Valproat Neuraxpharm Natriumvalproat 300mg Enhed
Valproat Neuraxpharm Sodium Valproate 300mg Units
Natriumvalproat 1000mg Brev
Sodium Valproate 1000mg Sachet
Depakine Chronosphere Valproinsyre 145.14mg Brev, Natriumvalproat
Depakine Chronosphere Valproic Acid 145.14mg Sachet, Sodium
Natriumvalproat 400mg Beholder
Sodium Valproate 400mg Vial
ácido Valpróico Generis Valproinsyre 145mg Tablet, Natriumvalproat 333mg Tablet
ácido Valpróico Generis Valproic Acid 145mg Tablet, Sodium
Epilim Chronosphere Valproinsyre 145.14mg Brev, Natriumvalproat
Epilim Chronosphere Valproic Acid 145.14mg Sachet, Sodium
Natriumvalproaat Teva Valproinsyre 145mg G, Natriumvalproat 333mg
Natriumvalproaat Teva Valproic Acid 145mg G, Sodium Valproate
Valproat Neuraxpharm Natriumvalproat 500mg Enhed
Valproat Neuraxpharm Sodium Valproate 500mg Units
Den Tjekkiske republic Sanofi-Aventis Sro
Sanofi-Aventis Sro
Natriumvalproat 500mg Enterotablet
Sodium Valproate 500mg Container
Seminatriumvalporat 250mg Tablet
Valproate Semisodium 250mg Tablet
Andre oplysninger om Ucedane
Other information about Ucedane
Den indledende daglige dosis af Ucedane er 100 mg pr. kg legemsvægt, om nødvendigt op til 250 mg/kg.
The initial daily dose of Ucedane should be 100 mg per kilogram body weight, but up to 250 mg/kg can be used if necessary.
Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Ucedane.
This is a summary of the European public assessment report (EPAR) for Ucedane.
Den fuldstændige EPAR for Ucedane findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The full EPAR for Ucedane can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Udvalget anbefalede, at Ucedane godkendes til anvendelse i EU.
The Committee recommended that Ucedane be approved for use in the EU.
Behandlingen kan begynde så tidligt som på den første levedag, og lægemidlet anvendes hele livet.
Treatment may be started as early as the first day of life and the medicine is used for the patient's whole life.
Hvad er Ucedane, og hvad anvendes det til?
What is Ucedane and what is it used for?
Ucedane cargluminsyre
Ucedane carglumic acid
Som for ethvert andet lægemiddel har virksomheden fremlagt undersøgelser af kvaliteten af Ucedane.
As for every medicine, the company provided studies on the quality of Ucedane.
Det er ikke en praktisk vejledning i, hvordan Ucedane bør anvendes.
It is not intended to provide practical advice on how to use Ucedane.
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Ucedane?
What measures are being taken to ensure the safe and effective use of Ucedane?
Ucedane fås som dispergible tabletter (200 mg), der skal blandes (dispergeres) med en lille smule vand.
Ucedane is available as dispersible tablets (200 mg) that are to be dispersed (mixed) in a small amount of water.
Når ammoniak ophobes i blodet, er det giftigt for kroppen, især hjernen.
When ammonia builds up in the blood, it is toxic to the body, especially the brain.
Hvilke fordele og risici er der forbundet med Ucedane?
What are the benefits and risks of Ucedane?
Udvalget for Lægemidler til Mennesker (CHMP) konkluderede, at Ucedane i overensstemmelse med EU's krav er påvist at være af sammenlignelig kvalitet og er bioækvivalent med Carbaglu.
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Ucedane has been shown to have comparable quality and to be bioequivalent to Carbaglu.
Hvis enzymet ikke er til stede, kan ammoniak ikke nedbrydes, men ophobes i blodet.
If the enzyme is not present, ammonia cannot be broken down and it builds up in the blood.
Lægemidlet udleveres kun mod recept, og behandlingen skal påbegyndes af en læge med erfaring i behandling af patienter med stofskiftesygdomme såsom NAGS-mangel.
The medicine can only be obtained with a prescription and treatment should be started by a doctor who has experience in treating patients with metabolic diseases such as NAGS deficiency.
Fordelene og risiciene ved det aktive stof til den godkendte anvendelse er i forvejen undersøgt med referencelægemidlet Carbaglu og behøver ikke gentages for Ucedane.
Studies on the benefits and risks of the active substance in the approved use have already been carried out with the reference medicine, Carbaglu, and do not need to be repeated for Ucedane.
Dosis bør derefter justeres for at opretholde et normalt indhold af ammoniak i blodet.
The dose should then be adjusted to maintain normal blood ammonia levels.
Da Ucedane er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses dets fordele og risici for at være de samme som for referencelægemidlet.
Because Ucedane is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.