FrancophonIA/ELRC3.0 huggingface dataset:
English: Docetaxel in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours over express HER2 and who previously have not received chemotherapy for metastatic disease.
Danish: Docefrez i kombination med trastuzumab er indiceret til behandling af patienter med metastatisk brystkræft, som har HER2-positive tumorer, og som ikke tidligere har modtaget kemoterapi mod metastatisk sygdom.
English: Docetaxel monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic therapy.
Danish: Docefrez-monoterapi er indiceret til behandling af patienter med lokalt fremskreden eller metastatisk brystkræft efter behandlingssvigt af kemoterapi.
English: Venous disorder
Danish: Venøs sygdom
English: HOW TO STORE DOCEFREZ
Danish: Docefrez indeholder
English: Asthenia (severe: 9.9%) Fluid retention (severe:
Danish: Asteni (alvorlig 9,9 %); Væskeretention (alvorlig: 0,7 %);
English: Neutropenia (G4:76.4%) Anaemia (G3/4: 8.9%); Febrile neutropenia
Danish: Neutropeni (G3/4: 83,2 %); Trombocytopeni (G3/4: 8,8 %); Febril neutropeni
English: Cardiac disorders Vascular disorders
Danish: Hjerte Vaskulære sygdomme
English: Powder and solvent for concentrate for solution for infusion 1 vial of powder
Danish: LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE) Pulver og solvens til koncentrat til infusionsvæske, opløsning 1 hætteglas med pulver
English: Abdominal pain upper;
Danish: Hud og subkutane væv Alopeci;
English: Infusion site reaction; Non-cardiac chest pain (severe: 0.4%)
Danish: Hud og subkutane væv Alopeci; Neglesygdomme (alvorlig: 0,7 %);
English: In the adjuvant treatment of operable node-positive and node-negative breast cancer, the recommended dose of docetaxel is 75 mg/m2 administered 1-hour after doxorubicin 50 mg/m2 and cyclophosphamide 500 mg/m2
Danish: Den anbefalede docetaxel-dosis til adjuverende behandling af operabel lymfeknude-positiv og lymfeknude-negativ brystkræft, er 75 mg/m2 hver 3. uge i 6 perioder, administreret 1 time efter doxorubicin 50 mg/m2 og cyclophosfamid 500 mg/m2 (TAC-regime) (se også: Dosisjustering under behandling).
English: Docetaxel 100 mg/m² single agent MedDRA system organ classes
Danish: Docefrez 100 mg/m2 enkeltstof: Systemorganklasser i henhold til MedDRAdatabasen
English: After reconstitution, 1 ml of concentrate contains 24 mg docetaxel (anhydrous).
Danish: Efter rekonstitution indeholder 1 ml koncentratet 24 mg docetaxel (vandfri).
English: Docetaxel 75 mg/m² in combination with cisplatin and 5-fluorouracil for gastric adenocarcinoma cancer MedDRA system organ classes Very common adverse reactions Common adverse reactions Infections and infestations
Danish: Docefrez 75 mg/m2 i kombination med cisplatin og 5-fluorouracil til gastrisk adenocarcinoma-kræft: Systemorganklasser i henhold til MedDRA-databasen
English: Arrhythmia (G3/4:
Danish: Neglesygdomme (G3/4:
English: Stomatitis/mucositis grade 3 First episode: reduce 5-FU dose by 20%.
Danish: Stomatitis/mucositis grad 3 Første episode: reducer 5-FU-dosis med 20 % Anden episode: stop kun 5-FU i alle efterfølgende cyklusser Tredje episode: reducer docetaxel-dosis med 20 % Stomatitis/mucositis grad 4 Første episode: stop kun 5-FU i alle efterfølgende cyklusser Anden episode: reducer docetaxel-dosis med 20 %
English: For patients who are dosed initially at docetaxel 75 mg/m2 in combination with cisplatin and whose nadir of platelet count during the previous course of therapy is <25.000 cells/mm3, or in patients who experience febrile neutropenia, or in patients with serious non-haematologic toxicities, the docetaxel dose in subsequent cycles should be reduced to 65 mg/m2.
Danish: I de følgende tilfælde bør docetaxel-dosis reduceres til 65 mg/ m i de følgende behandlingsrunder: 1) hos patienter med en initialdosis på 75 mg/m2 docetaxel i kombination med cisplatin, med en minimum blodpladeværdi under den tidligere behandlingsrunde på < 25000 celler/mm3, 2) hos patienter, der får febril neutropeni, 3) hos patienter, med alvorlig, ikke hæmatologisk toksicitet.
English: For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
Danish: Hvis du vil have yderligere oplysninger om Docefrez, skal du henvende dig til den lokale repræsentant.
English: Docefrez 80 mg powder and solvent for concentrate for solution for infusion Docetaxel
Danish: Docefrez 80 mg pulver og solvens til koncentrat til infusionsvæske, opløsning Docetaxel
English: Disposal
Danish: OPBEVARING
English: Rash pruritus (G3/4: 0.7%); Nail disorders (G3/4: 0.7%); Skin exfoliation (G3/4: 0%).
Danish: Kløende udslæt (G3/4: 0,7 %); Neglesygdomme (G3/4: 0,7 %); Hudafskalning (G3/4: 0 %)
English: A hazard ratio of less than 1 favors docetaxel + cisplatin + fluorouracil
Danish: Med en hazard ratio < 1 kan docetaxel * Ujusteret logrank test
English: Pain in extremity (G3/4: <1%); Back pain (G3/4: 1%);
Danish: Smerter i ekstremiteterne (G3/4: < 1 %);
English: Hearing impaired (G3/4: 1.2%)
Danish: Nedsat hørelse (G3/4: 1,2 %)
English: Stomatitis (G3/4: 18%); Diarrhoea (G3/4: 14%); Nausea (G3/4: 6%);
Danish: Stomatitis (G3/4: 18 %); Diarré (G3/4: 14 %);
English: Docetaxel in combination with platinum agents in chemotherapy-naïve patients
Danish: Docefrez i kombination med platinmidler hos patienter der ikke tidligere er behandlet med kemoterapi
English: POSSIBLE SIDE EFFECTS
Danish: Almindelige bivirkninger
English: If docetaxel powder, reconstituted concentrate, or solution for infusion should come into contact with mucous membranes, wash immediately and thoroughly with water.
Danish: Hvis docetaxel-pulver, rekonstitueret koncentrat eller infusionsvæske kommer i kontakt med slimhinderne, skal det straks vaskes af med vand.
English: Docefrez 20 mg powder and solvent for concentrate for solution for infusion Docetaxel
Danish: Docefrez 20 mg pulver og solvens til koncentrat til infusionsvæske, opløsning Docetaxel
English: 5 ml colourless type 1 glass vial with grey bromobutyl rubber stopper and sealed with a dark green colour flip-off aluminium seal.
Danish: 5 ml farveløst type 1-hætteglas med grå bromobutylgummiprop og mørkegrøn flip-offaluminiumforsegling.
English: 5-fluorouracil (clinically important treatment related adverse events are presented).
Danish: • doxorubicin og cyclophosphamid (bivirkninger til klinisk vigtig behandling er præsenteret).
English: Adjusted Hazard ratio (95%CI) *p-value
Danish: Tilpasset hazard ratio (95 % CI) *p-værdi
English: 1-year Survival (%)
Danish: Total overlevelse (Primær endepunkt) Median overlevelsestid (måneder) 1-års overlevelse (%) 2-års overlevelse (%)
English: Exfoliative rash (G3/4: 0.3%)
Danish: Exfoliativt udslæt (G3/4: 0,3 %)
English: (FISH).
Danish: (øsofagitis)
English: Docetaxel 75 mg/m² in combination with prednisone or prednisolone MedDRA system organ classes Very common adverse reactions Common adverse reactions Infections and infestations
Danish: Docefrez 75 mg/m2 i kombination med prednison eller prednisolon: Meget almindelige bivirkninger
English: Myalgia disorders
Danish: Perifer motorisk neuropati
English: Stomatitis (G3/4: 4.0%); Diarrhoea (G3/4: 2.9%); Vomiting (G3/4: 0.6%)
Danish: Diarré (G3/4: 2,9 %); Opkastning (G3/4: 0,6 %)
English: Sclerodermal-like changes usually preceded by peripheral lymphoedema have been reported with docetaxel.
Danish: Ved behandling med docetaxel er der rapporteret om sclerodermi-lignende forandringer, som ofte går forud for perifer lymfødem.
English: Hypotension; Hypertension; Haemorrhage
Danish: Hypotension Hypertension Hæmoragi
English: Undesirable effects on the testis observed in rodent toxicity studies suggest that docetaxel may impair male fertility.
Danish: Toksikologiske forsøg på gnavere har vist uønskede påvirkninger af testisfunktionen.
English: Docefrez 80 mg, Powder for Concentrate for Solution for Infusion
Danish: Docefrez 80 mg pulver til koncentrat til infusionsvæske, opløsning
English: Asthenia (G3/4: 10.0%); Pyrexia (G3/4: NA);
Danish: Asteni (G3/4: 10,0 %); Feber (G3/4: NA);
English: Docefrez 20 mg powder for concentrate for solution for infusion
Danish: Docefrez 20 mg pulver til koncentrat til infusionsvæske, opløsning
English: The solvent for Docefrez is 35.4% w/w Ethanol in Polysorbate 80.
Danish: Solvensen til Docefrez indeholder 35,4 % (w/w) ethanol i polysorbat 80.
English: Nausea (G3/4: 5%);
Danish: Opkastning (G3/4: 5 %);
English: Docefrez 80 mg powder and solvent for concentrate for solution for infusion
Danish: Docefrez 80 mg pulver og solvens til koncentrat til infusionsvæske, opløsning
English: Stomatitis (G3/4: 5.3%); Diarrhoea (G3/4: 4%);
Danish: Kvalme (G3/4: 2,4 %); Diarré (G3/4: 1,2 %);
English: Docetaxel 100 mg/m² in combination with trastuzumab: MedDRA system organ classes
Danish: Docefrez 100 mg/m2 i kombination med trastuzumab:
English: Nausea (G3/4: 2.4%);
Danish: Infektioner (G3/4: 2,4 %);
English: Peripheral motor neuropathy (G3/4: 4%); Dysgeusia (severe
Danish: Perifer sensorisk neuropati (G3: 4,1 %); Perifer motorisk neuropati (G3/4: 4 %); Dysgeusi (alvorlig:
English: Patients on the docetaxel arm received docetaxel (T) 75 mg/m² by intravenous infusion on day 1 followed by cisplatin (P) 100 mg/m² administered as a 30-minute to three-hour intravenous infusion, followed by the continuous intravenous infusion of 5-fluorouracil (F) 1000 mg/m²/day from day 1 to day 4.
Danish: Patienter i docetaxel-armen modtog docetaxel (T) 75 mg/m2 ved intravenøs infusion på dag 1, efterfulgt af cisplatin (P) 100 mg/m2 administreret som en 30 minutter til
English: Alopecia (G3/4: 4.0%).
Danish: Alopeci (G3/4: 6 %);
English: Median TTP (months) (95%CI)
Danish: Gennemsnitlig TTP (måneder) (95 % CI)
English: Diarrhoea (G3/4: 3.4%);
Danish: Diarré (G3/4: 19,7 %);
English: Docefrez 20 mg powder and solvent for concentrate for solution for infusion
Danish: Docefrez 20 mg pulver og solvens til koncentrat til infusionsvæske, opløsning
English: Constipation (G3/4: 0.5%)
Danish: Konstipation (G3/4: 0,4 %)
English: • fainting
Danish: • besvimelse
English: Oedema (G3/4: 1.2%)
Danish: Arytmi (G3/4: 1,0 %)
English: Nail disorders (G3/4: 2%)
Danish: Stomatitis (G3/4: 2 %)
English: Nausea (G3/4: 13.9%); Stomatitis (G3/4:
Danish: Mave-tarmkanalen Kvalme (G3/4: 13,9 %); Stomatitis (G3/4: 20,7 %);
English: Hypotension (G3/4: 0%) Phlebitis (G3/4: 0%)
Danish: Vaskulære sygdomme Hedeture (G3/4: 0,5%) Hypotension (G3/4: Flebitis (G3/4: 0 %)
English: Diarrhoea (G3/4:
Danish: Hudsygdomme (G3/4:
English: PREPARATION GUIDE FOR USE WITH DOCEFREZ 80 MG, POWDER AND SOLVENT FOR CONCENTRATE FOR SOLUTION FOR INFUSION
Danish: FREMSTILLINGSVEJLEDNING TIL BRUG VED DOCEFREZ 80 MG KONCENTRAT TIL INFUSIONSVÆSKE, OPLØSNING OG OPLØSNINGSVÆSKE TIL DOCEFREZ
English: Vomiting (G3/4: 1.2%)
Danish: Cancersmerter (G3/4: 1,2 %)
English: Pharyngolaryngeal pain (G3/4: 2%)
Danish: Luftveje, thorax og mediastinum Faryngolaryngeale smerter (G3/4: 2 %)
English: Overall survival (Primary endpoint)
Danish: Progressionstid (TTP) var det primære endepunkt.
English: Esophagitis/dysphagia/ odynophagia (G3/4:
Danish: Øsofagitis/dysfagi/ odynofagi (G3/4: 12,0 %)
English: Constipation (G3/4: 1%); Abdominal pain (G3/4: 2%); Dyspepsia
Danish: Kvalme (G3/4: 6 %); Opkastning (G3/4: 4 %); Konstipation (G3/4: 1 %); Mavesmerter (G3/4: 2 %); Dyspepsi
English: Onycholysis (G3/4: 1%)
Danish: Epistaxis (G3/4: < 1 %)
English: 1060 patients were randomized to receive either docetaxel 75 mg/m2 administered 1-hour after doxorubicin 50 mg/m2 and cyclophosphamide 500 mg/m2 (539 patients in TAC arm), or doxorubicin 50 mg/m2 followed by fluorouracil 500 mg/m2 and cyclosphosphamide 500 mg/m2 (521 patients in FAC arm), as adjuvant treatment of operable node-negative breast cancer patients with high risk of relapse according to 1998 St. Gallen criteria (tumour size > 2 cm and/or negative ER and PR and/or high histological/nuclear grade (grade 2 to 3) and /or age < 35 years).
Danish: Patienterne havde operabel, lymfeknude-negativ brystkræft med høj risiko for tilbagefald ifølge 1998 St. Gallen-kriterierne (tumorstørrelse > 2 cm og/eller negative østrogenreceptorer (ER) og progesteronreceptorer (PR) og/eller høj histologisk/nukleær grad (grad 2 til 3) og/eller alder < 35 år).
English: Arrythmia (G3/4:0.7%)
Danish: Hypotension (G3/4: 0,7 %)
English: Hearing impaired (G3/4: 0%).
Danish: Nedsat hørelse (G3/4: 0 %)
English: Hazard ratio (95%CI) *p-value
Danish: Hazard ratio (95 % CI) *p-værdi
English: Lymphoedema
Danish: Docefrez
English: Patients should be retreated with docetaxel when neutrophils recover to a level ≥1,500 cells/mm3 (see section 4.2).
Danish: Behandling med docetaxel bør gentages, når neutrocyttallet igen er ≥ 1.500 celler/mm3.
English: Stomatitis (G3/4: 6.0%);
Danish: Diarré (G3/4: 6,4 %);
English: Hazard ratio (95%CI) **p-value
Danish: Hazard ratio (95% CI) **p-værdi
English: Epistaxis; Pharyngolaryngeal pain; Nasopharyngitis;
Danish: Luftveje, thorax og mediastinum Epistaxis; faryngolaryngeal smerte; nasofaryngitis; dyspnø; hoste; næseflåd
English: Docetaxel 100 mg/m² single agent
Danish: Efter administration af docetaxel 100 mg/m2 givet som infusion over 1
English: For example, a dose of 140 mg docetaxel would require one 80 mg and three 20 mg packs.
Danish: For eksempel skal der 1 pakning med 80 mg og 3 med 20 mg til en dosis på 140 mg docetaxel.
English: Nausea (G3/4: 5.0%);
Danish: Svimmelhed (G3/4: 2,0 %);
English: Uncommon side effects:
Danish: Ikke almindelige bivirkninger
English: Diarrhoea (G3/4: 1.2%);
Danish: Diarré (G3/4: 6,2 %);
English: Diarrhoea (G3/4: 19.7%); Nausea (G3/4: 16%);
Danish: Mave-tarmkanalen Kvalme (G3/4: 5 %); Stomatitis (G3/4: 7,8 %);
English: Docetaxel in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with: - operable node-positive breast cancer - operable node-negative breast cancer.
Danish: Docefrez i kombination med doxorubicin og cyclophosfamid er indiceret til adjuverende behandling af patienter med:
English: Dysgeusia/Parosmia; Peripheral sensory neuropathy (G3/4: 0.6%)
Danish: Perifer sensorisk neuropati (G3/4: 0,6 %)
English: Invented name Strengths Pharmaceutical Form Route of administration
Danish: EU's procedurenr Særnavn Styrker
English: Packaging Content
Danish: Lægemiddelform Indgivelsesvej Emballage Indhold
English: Package size blister (PVC/alu) 336 (4 packs of 84) hard capsules blister (PVC/alu) 84 hard capsules
Danish: 336 (4 pakker af 84) hårde kapsler
English: (Invented) name Strength Pharmaceutical Form Route of Administration
Danish: Særnavn Styrke Lægemiddelform Indgivelsesvej Emballage
English: Within 1 month of Commission Decision.
Danish: Senest 1 måned efter Kommissionens beslutning.
English: These should be submitted to the National Competent Authorities:
Danish: De bør fremsendes til de nationale kompetente myndigheder:
English: The clinical study report should be submitted to the relevant National Competent Authorities:
Danish: Den kliniske undersøgelsesrapport bør forelægges de relevante nationale kompetente myndigheder:
English: The details of the visual reminder should be agreed at national level further to a user test taking into account input from local patient representatives.
Danish: De nærmere detaljer for den visuelle påmindelse bør aftales på nationalt plan og samtidig undersøges i en brugertest, der tager hensyn til input fra lokale patientrepræsentanter.
English: The study design should aim to evaluate and quantify the effectiveness of the Risk Management Measures, and should include a pre- and post-implemented analysis and assessment.
Danish: Undersøgelsens design bør stile mod at evaluere og kvantificere effektiviteten af risikostyringsforanstaltningerne og omfatte en analyse og en vurdering fra før og efter gennemførelsen.
English: The marketing authorisation holder(s) for oral retinoids acitretin, alitretinoin and isotretinoin shall complete the below conditions, within the stated timeframe, and competent authorities shall ensure that the following is fulfilled:
Danish: Indehaverne af markedsføringstilladelse for de orale retinoider acitretin, alitretinoin og isotretinoin skal opfylde nedenstående betingelser inden for den angivne tidsfrist, og de kompetente myndigheder skal sikre, at følgende er opfyldt:
English: A visual reminder on the outer package to warn patients about the harm to unborn baby and the need for effective contraception when using the medicinal product should be implemented in all medicinal products-containing oral retinoids acitretin, alitretinoin and isotretinoin.
Danish: En visuel påmindelse på yderemballagen som advarsel til patienterne om risikoen for skade på det ufødte barn og nødvendigheden af at anvende sikker prævention ved behandling med lægemidlet bør gennemføres for alle lægemidler, der indeholder de orale retinoider acitretin, alitretinoin og isotretinoin.
English: These materials should ensure that prescribers are informed and the patients understand and acknowledge the risks associated with oral retinoids acitretin, alitretinoin and isotretinoin in-utero exposure.
Danish: Disse materialer bør sikre, at ordinerende læger er informeret, og at patienterne forstår og anerkender risiciene ved in utero-eksponering for de orale retinoider acitretin, alitretinoin og isotretinoin.
English: In order to assess the effectiveness of the updated risk minimisation measures in women of childbearing potential resulting from this referral procedure, MAH(s) of oral retinoids acitretin, alitretinoin and isotretinoin should conduct and submit the results of a drug utilisation study (DUS).
Danish: For at vurdere virkningen af de opdaterede risikominimerende foranstaltninger hos kvinder i den fødedygtige alder efter denne indbringelsesprocedure bør indehaverne af markedsføringstilladelse for de orale retinoider acitretin, alitretinoin og isotretinoin gennemføre en undersøgelse af lægemiddelanvendelsen og indsende undersøgelsesresultaterne.
English: The MAHs of oral retinoids containing acitretin, alitretinoin or isotretinoin shall develop and submit educational materials according to the agreed key elements.
Danish: Indehaverne af markedsføringstilladelse for de orale retinoider acitretin, alitretinoin og isotretinoin skal udarbejde og fremsende informationsmateriale i overensstemmelse med de vedtagne hovedpunkter.
English: 25 mg Film-coated tablet
Danish: 50 x 1 tabletter
English: EU/1/07/383/001 Januvia
Danish: MF (EU)-nummer
English: Page 2 of 2
Danish: (enkeltdosis)
English: The programme may last up to approximately a year.
Danish: Programmet kan vare i op til ca. et år.
English: However, knowledge on the long-term effect of the medicine is limited.
Danish: Kendskabet til langtidseffekten af lægemidlet er imidlertid begrænset.
English: The European Commission granted a marketing authorisation valid throughout the European Union for ChondroCelect on 5 October 2009.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for ChondroCelect den 5. oktober 2009.
English: The full EPAR for ChondroCelect can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for ChondroCelect findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This is a summary of the European public assessment report (EPAR) for ChondroCelect.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for ChondroCelect.
English: A risk management plan has been developed to ensure that ChondroCelect is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at ChondroCelect anvendes så sikkert som muligt.
English: What measures are being taken to ensure the safe and effective use of ChondroCelect?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af ChondroCelect?
English: The defects were on the femoral condyle and were between 1 and 5 cm2 in size.
Danish: Defekterne befandt sig på femurkondylen, og deres størrelse var på mellem 1 og 5 cm2.
English: Cartilage in the knee can be damaged because of an accident, such as a fall, or because they wear off.
Danish: Bruskdefekter kan opstå som følge af en ulykke, f.eks. et fald, eller på grund af nedslidning.
English: ChondroCelect is a medicine that is prepared specially for each individual patient and can only be used to treat the particular patient it was prepared for.
Danish: ChondroCelect er et lægemiddel, som fremstilles specielt til den enkelte patient, og det kan kun anvendes til behandling af den pågældende patient, det blev fremstillet til.
English: For more information about treatment with ChondroCelect, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med ChondroCelect, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: These cells repair the defects in the knee by producing new cartilage.
Danish: Disse celler reparerer defekterne i knæet ved at danne nyt brusk.
English: Other information about ChondroCelect
Danish: Andre oplysninger om ChondroCelect
English: The CHMP considered that ChondroCelect was shown to be effective at treating defects in the knee cartilage between 1 and 5 cm2 in size, and that the safety profile was considered acceptable.
Danish: CHMP vurderede, at det var påvist, at ChondroCelect var effektivt til behandling af bruskdefekter i kræet på mellem 1 og 5 cm2, og sikkerhedsprofilen ansås for at være acceptabel.
English: ChondroCelect was compared with microfracture (a type of surgery used to treat defects in cartilage) in one main study involving 118 adult patients with symptoms caused by defects in their knee cartilage.
Danish: ChondroCelect blev sammenlignet med mikrofraktur (en type kirurgi til behandling af bruskdefekter) i en hovedundersøgelse, hvori der deltog 118 voksne patienter med symptomer forårsaget af bruskdefekter i knæet.
English: The active substance in ChondroCelect is the patient's own cartilage cells.
Danish: Det aktive stof i ChondroCelect er patientens egne bruskceller.
English: Patients treated with ChondroCelect should follow specific rehabilitation programme, including physiotherapy.
Danish: Patienter, som er blevet behandlet med ChondroCelect, skal følge et særligt genoptræningsprogram, som bl.a. omfatter fysioterapi.
English: The main measures of effectiveness were how well the defects had healed after one year and the change in the patients' Knee Injury and Osteoarthritis Outcome Score (KOOS) after one and three years of treatment.
Danish: Virkningen blev hovedsageligt målt på, hvor godt defekterne var helet efter et år, samt ændringen af patienternes KOOS-score (Knee Injury and Osteoarthritis Outcome Score) efter et og tre års behandling.
English: ChondroCelect must be administered by a qualified surgeon in a hospital.
Danish: ChondroCelect skal indgives af en kvalificeret kirurg på et hospital.
English: First, a biopsy (a small sample) is taken from the patient's cartilage in the knee.
Danish: Først tages en biopsi (en lille prøve) fra patientens brusk i knæet.
English: In addition, the company that makes ChondroCelect will ensure that all surgeons and other healthcare professionals involved in the handling or use of ChondroCelect receive training materials on how to use the product.
Danish: Virksomheden, som fremstiller ChondroCelect, skal endvidere sikre, at alle kirurger og andet sundhedspersonale, som er inddraget i håndteringen eller anvendelsen af ChondroCelect, modtager undervisningsmaterialer om, hvordan lægemidlet anvendes.
English: Because ChondroCelect is an advanced therapy medicine, it was assessed by the Committee for Advanced Therapies (CAT).
Danish: Da ChondroCelect er et lægemiddel til avanceret terapi, blev det vurderet af Udvalget for Avancerede Terapier (CAT).
English: A biological membrane is then used as a seal to keep the cells in place while the cartilage repairs.
Danish: Herefter anvendes en biologisk membran som forsegling for at holde cellerne på plads, mens brusken repareres.