FrancophonIA/ELRC3.0 huggingface dataset:
English: What Topotecan Actavis looks like and contents of the pack Topotecan Actavis is supplied in type I colourless glass vials with grey bromobutylic stopper and aluminium seals with plastic flip-off caps.
Danish: Topotecan Actavis leveres i type I farveløst hætteglas, type I, med grå brombutylprop og aluminiumsforsegling med plastik flip-off låg.
English: nausea, vomiting and diarrhoea (all of which may be severe)
Danish: Mave-tarm-kanalen Meget almindelig: kvalme, opkastning og diaré (alle muligvis alvorlige)
English: Topotecan Actavis 4 mg vials must be reconstituted with 4 ml water for injections.
Danish: Topotecan Actavis 4 mg hætteglas skal opløses med 4 ml vand til injektionsvæsker.
English: For more information about cisplatin, please refer to the corresponding package leaflet.
Danish: For mere information om cisplatin, se tilsvarende indlægsseddel for cisplatin.
English: Neutropenic colitis, including fatal neutropenic colitis, has been reported to occur as a complication of topotecaninduced neutropenia (see section 4.4).
Danish: 2Neutropenisk colitis, herunder dødelig neutropenisk colitis, er set som en komplikation til topotecan-induceret neutropeni
English: The second study included a dose range of 2.0 mg/m to
Danish: Det andet studie med et doseringsinterval på 2,0 mg/m2-5,2 mg/m2 til børn
English: EXPIRY DATE
Danish: UDLØBSDATO Udløbsdato:
English: - The other ingredients are: mannitol (E421), tartaric acid (E334), hydrochloric acid (E507) and sodium hydroxide.
Danish: Øvrige indholdsstoffer: mannitol (E421), vinsyre (E334), saltsyre (E507) og natriumhydroxid.
English: Topotecan Actavis is not recommended in case of severe liver impairment; - if you suffer from lung inflammation with signs such as cough, fever and difficulties in breathing, see also section 4 “Possible side effects”.
Danish: hvis du har en lungebetændelse med tegn som hoste, feber og vejrtrækningsproblemer, se også punkt 4 ”Bivirkninger”.
English: A phase III trial (study 478) compared oral topotecan plus Best Supportive Care (BSC) (n = 71) with BSC alone (n = 70) in patients who had relapsed following first line therapy (median time to progression [TTP] from first-line therapy: 84 days for oral topotecan + BSC, 90 days for BSC) and for whom retreatment with intravenous chemotherapy was not considered appropriate.
Danish: I en fase III (forsøg 478) undersøgelse blev oral topotecan plus Best Supportiv Care (BSC) (n = 71) sammenlignet med BSC alene [n = 70] hos patienter, som havde tilbagefald efter førstelinjebehandling (mediantid til progression (TTP) efter førstelinjebehandling: 84 dage for oral topotecan + BSC, 90 dage for BSC) og for hvem gentagelse af behandling med intravenøs kemoterapi ikke var hensigtsmæssig.
English: When given in combination with cisplatin (cisplatin day 1, topotecan days 1 to 5), the clearance of topotecan was reduced on day 5 compared to day 1 (19.1 l/h/m compared to 21.3 l/h/m
Danish: Ved administration i kombination med cisplatin (cisplatin dag 1, topotecan dag 1 til 5) blev topotecanclearance reduceret på dag 5 sammenlignet med dag 1 (19,1 l/time/m2 legemsoverflade sammenlignet med 21,3 l/h/m2 legemsoverflade [n = 9] (se pkt.
English: 12 years, n = 18), adolescents (aged 12 up to 16 years, n = 9), and young adults (aged 16 to 21 years, n = 9) with refractory solid tumours.
Danish: Et studie med et doseringsinterval på 1,4 mg/m2-2,4 mg/m2/dag til børn (fra 2 år og op til 12 år; n = 18), til unge (fra 12 år op til 16 år; n = 9) og yngre voksne (fra 16 år op til 21 år; n = 9) med refraktære solide tumorer.
English: severe bleeding (associated with thrombocytopenia) Immune system disorders
Danish: alvorlig blødning (associeret med trombocytopeni)
English: : 2.6, 6.1) versus 4.5 months (95 % C.I.
Danish: (95 % CI: 2,6; 6,1) versus 4,5 mdr.
English: Monotherapy (Small cell lung carcinoma)
Danish: Monoterapi (småcellet lungecancer):
English: : 2.9, 9.6) for the cisplatin arm with an hazard ratio of 1.15 (0.59, 2.23).
Danish: (95 % CI: 2,9; 9,6) for gruppen, der fik cisplatin alene og med et risikoforhold på 1,15 (0,59;2,23).
English: 9/l) during course 1 was seen in 55 % of the patients and with duration ≥ seven days in 20 % and overall in 77 % of patients (39 % of courses).
Danish: Neutropeni: Alvorlig (neutrofiltal < 0,5 x 109/l) under behandlingsperiode 1 blev observeret hos 55 % af patienterne og med en varighed ≥ syv dage hos 20 % og totalt set hos 77 % af patienterne (39 % af behandlingerne).
English: The elimination of topotecan has only been partly investigated in man. A major route of clearance of topotecan was by hydrolysis of the lactone ring to form the ring-opened carboxylate.
Danish: En vigtig clearance måde for topotecan var hydrolyse af laktonringen, så der dannedes ringåbnet carboxylat.
English: 5 x 4 mg vial
Danish: 5 x 4 mg hætteglas
English: - Topotecan Actavis 1 mg with 1.1 ml water for injections (as it contains 10 % overage of fill) - Topotecan Actavis 4 mg with 4 ml water for injections
Danish: Topotecan Actavis pulver til koncentrat for infusionsvæske, skal før infusion rekonstitueres med en passende mængde vand til injektioner, som følger: - Topotecan Actavis 1 mg med 1.1 ml vand til injektioner (da det indeholder 10 % overskud) - Topotecan Actavis 4 mg med 4 ml vand til injektioner Rekonstitueringen vil resultere i en koncentrat indeholdende 1 mg topotecan pr. ml.
English: : 4.9, 9.5) for the cisplatin arm with a hazard ratio of 0.75 (0.49, 1.16).
Danish: (95 % CI: 4,9; 9,5) for gruppen, der fik cisplatin alene og med et risikoforhold på 0,75 (0,49; 1,16).
English: - Decrease in the number of all blood cells (pancytopenia) - Feeling unwell.
Danish: - Nedsat antal af alle typer af blodlegemer (pancytopenia) - Utilpashed - Alvorlig blodinfektion, som kan være dødelig.
English: 9/l) for seven days or more, or severe neutropenia associated with fever or infection or who have had treatment delayed due to neutropenia, the dose should be reduced by 20 % to 0.60 mg/m2/day for subsequent courses (or subsequently down to 0.45 mg/m2/day if necessary).
Danish: Ved dosisreduktion hos patienter, som oplever alvorlig neutropeni (neutrofiltal <0,5 x 109/l) i syv dage eller mere, eller alvorlig neutropeni forbundet med feber eller infektion, eller hvis behandlingen er blevet udskudt på grund af neutropeni, bør dosis reduceres med 20 % til 0,60 mg/m2/dag i de efterfølgende behandlinger (eller derefter om nødvendigt ned til 0,45 mg/m2/dag).
English: Contains mannitol (E421), tartaric acid (E334), hydrochloric acid (E507) and sodium hydroxide.
Danish: Mannitol (E421), vinsyre (E334), saltsyre (E507) og natriumhydroxid.
English: 5 x 1 mg vial
Danish: 5 x 1 mg hætteglas
English: The usual dose is 0.75 mg per m of body surface area once daily for 3 days.
Danish: Livmoderhalskræft Den sædvanlige dosis er 0,75 mg/m2 af kroppens overfladeareal pr. dag i 3 dage.
English: Other medicines and Topotecan Actavis Tell your doctor if you are taking, have recently taken or might take any other medicines.
Danish: Fortæl det altid til lægen eller på apoteket, hvis du bruger anden medicin eller har gjort det for nylig.
English: The volume of reconstituted concentrate corresponding to the calculated individual dose, should be further diluted with either sodium chloride 9 mg/ml (0.9 %) solution for injection or 50 mg/ml (5 %) glucose solution for infusion, to a final concentration of between 25 and 50 microgram per ml in the solution for infusion, for example:
Danish: Volumen af den rekonstituerede koncentrat svarer til den beregnede individuelle dosis og skal fortyndes yderligere med enten natriumchlorid 9 mg/ml (0,9 %) i opløsning til injektioner eller 50 mg/ml (5 %) glucoseopløsning til infusion, til den endelige koncentration på mellem 25 og 50 mikrogram pr. ml til opløsning for infusion, f.eks.:
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2).
Danish: Lægemidlet må kun udleveres efter begrænset recept (jf. bilag I: Produktresumé; pkt.
English: Patients without prior cisplatin chemoradiotherapy Cisplatin
Danish: Patienter uden forudgåede cisplatin kemo/stråleterapi cisplatin topotecan/cisplatin
English: Median (95 % C.I) Hazard ratio (95 % C.I.)
Danish: Median (95 % C.I) Risikoforhold (95 % CI)
English: 9/l) for seven days or more, or severe neutropenia associated with fever or infection, or who have had treatment delayed due to neutropenia, the dose should be reduced by 0.25 mg/m 2/day to 1.25 mg/m 2/day (or subsequently down to 1.0 mg/m 2/day if necessary).
Danish: Hvis dosisreduktion er valgt til patienter som oplever alvorlig neutropeni (neutrofiltal < 0,5 x 109/l) i syv dage eller mere, eller alvorlig neutropeni forbundet med feber eller infektion, eller hvis behandling er blevet udskudt på grund af neutropeni, skal dosis reduceres 0,25 mg/m2/dag til 1,25 mg/m2 /dag (eller derefter om nødvendigt ned til 1,0 mg/m2 /dag).
English: malaise
Danish: udslæt
English: Myelosuppression leading to sepsis and fatalities due to sepsis have been reported in patients treated with topotecan (see section 4.8).
Danish: Der er rapporteret om myelosuppression, der har ført til sepsis, som igen har ført til dødsfald, efter behandling med topotecan (se pkt 4.8).
English: Small Cell Lung Carcinoma
Danish: Småcellet lungecancer
English: The clear concentrate is pale yellow in colour and provides 1 mg per ml of topotecan.
Danish: Det klare koncentrat, hvis farve er lys gul, indeholder 1 mg/ml topotecan.
English: Topotecan Actavis; - if your blood cell counts are too low.
Danish: − hvis dine blodcelletal er for lavt.
English: Topotecan Actavis 1 mg powder for concentrate for solution for infusion Topotecan Actavis 4 mg powder for concentrate for solution for infusion topotecan
Danish: Topotecan Actavis 1 mg pulver til koncentrat til infusionsvæske, opløsning Topotecan Actavis 4 mg pulver til koncentrat til infusionsvæske, opløsning topotecan
English: SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE Any unused product or waste material should be disposed of in accordance with local requirements.
Danish: EVENTUELLE SÆRLIGE FORHOLDSREGLER VED BORTSKAFFELSE AF UBRUGTE LÆGEMIDLER ELLER AFFALD FRA SÅDANNE
English: - Lung inflammation (rare; may affect up to 1 in 1,000 people), with signs such as: - difficulty in breathing - cough - fever The risk of developing this severe condition (interstitial lung disease) is higher if you currently have lung problems, or if you have received previous radiation treatment or medicines that affected your lungs, see also section 2 “Warnings and precautions”.This condition can be fatal.
Danish: Risikoen for at udvikle denne alvorlige tilstand (interstitiel lungesygdom) er højere, hvis du allerede har en lungesygdom, eller hvis du tidligere har fået strålebehandling, eller medicin der påvirkede dine lunger.
English: Dosage in renally impaired patients
Danish: Dosering til patienter med nedsat nyrefunktion
English: Common side effects (may affect up to 1 in 10 people) - Allergic (hypersensitivity) reactions (including rash).
Danish: Sjældne bivirkninger (kan ske hos 1 ud af 1.000personer): - Alvorlige allergiske (anafylaktiske) reaktioner.
English: Each vial contains 1 mg or 4 mg topotecan (as hydrochloride).
Danish: Hvert hætteglas indeholder 1 mg eller 4 mg topotecan (som hydrochlorid).
English: General disorders and administration site conditions Very common:
Danish: Almene symptomer og reaktioner på administrationsstedet Meget almindelig: pyreksi
English: Topotecan has been shown to cause embryo-foetal lethality and malformations in preclinical studies (see section 5.3).
Danish: Prækliniske forsøg har vist, at topotecan fremkalder embryo/fosterdødelighed og misdannelser (se pkt.
English: : 7, 12.6) versus 6.3 months (95 % C.I.
Danish: (95 % CI: 7; 12,6) versus 6,3 mdr.
English: How to use Topotecan Actavis
Danish: Sådan bruges Topotecan Actavis
English: When used in combination with cisplatin, the full prescribing information for cisplatin should be consulted.
Danish: Ved kombination med cisplatin, skal man være opmærksom på cisplatins produktinformation.
English: CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND
Danish: B. BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING OG ANVENDELSE
English: Further dilution of the appropriate volume of the reconstituted solution with either sodium chloride 9 mg/ml (0.9 %) solution for injection or 50 mg/ml (5 %) glucose solution for infusion is required to a final concentration of between 25 and 50 microgram/ml.
Danish: Yderligere fortynding af den rekonstituerede opløsning med enten natriumchlorid 9 mg/ml (0,9 %) opløsning til injektion eller 50 mg/ml (5 %) glucoseopløsning til infusion, er påkrævet for at opnå den endelige koncentration på mellem 25 og 50 mikrogram/ml.
English: However, as with other cytotoxic medicinal products topotecan is genotoxic and effects on fertility, including male fertility, cannot be excluded.
Danish: Topotecan er dog som andre cytostatika genotoksisk, og påvirkning af fertiliteten, inkl.
English: Patients with prior cisplatin chemoradiotherapy Cisplatin
Danish: Patienter med forudgående cisplatin kemo/stråleterapi topotecan/cisplatin
English: Tel: +43 (0)662 435 235 00
Danish: Actavis GmbH Tel: +43 (0)662 435 235 00
English: Posology
Danish: INSTRUKTION
English: Fatalities due to neutropenic colitis have been reported in clinical trials with topotecan.
Danish: I kliniske forsøg med topotecan har man set dødsfald på grund af neutropenisk colitis.
English: You should stop breast-feeding before starting treatment with
Danish: Du skal stoppe med at amme, før din behandling med Topotecan Actavis
English: interstitial lung disease (some cases have been fatal) Gastrointestinal disorders Very common:
Danish: interstitiel lungesygdom (som i nogle tilfælde har været dødelige)
English: Cervical carcinoma
Danish: Cervixcancer:
English: Small cell lung cancer The usual dose is 1.5 mg per m of body surface area once daily for 5 days.
Danish: Den sædvanlige dosis er: 1,5 mg/m2 af kroppens overfladeareal en gang om dagen i 5 dage.
English: Oral and intravenous topotecan were associated with similar symptom palliation in patients with relapsed sensitive SCLC in patient selfreports on an unblinded symptom scale assessment in each of these two studies.
Danish: I patienternes egne rapporteringer vha. en ublindet vurdering på en symptomskala i begge forsøg, var oral og intravenøs topotecan forbundet med samme symptomlindring hos patienter med recidiverende, sensitiv SCLC.
English: - Abnormal high level of bilirubin, a waste product produced by the liver during breakdown of red blood cells.
Danish: Almindelige bivirkninger (kan ske hos 1 ud af 10 personer): - Unormalt højt niveau af bilirubin, et restprodukt som leveren producerer under nedbrydelsen af røde blodceller.
English: Prior to administration of the first course of topotecan, patients must have a baseline neutrophil count of ≥ 1.5 x 10
Danish: Før administration af den første behandling med topotecan skal patienten have et baseline-neutrofiltal på ≥ 1,5 x 109/l og et trombocyttal på ≥ 100 x 109/l og et hæmoglobinniveau på ≥ 9g/dl (om nødvendigt efter transfusion).
English: - Severe allergic (anaphylactic) reactions (rare; may affect up to 1 in 1,000 people), with signs such as: - swelling of the face, lips, tongue or throat, difficulty breathing, low blood pressure, dizziness and itchy rash.
Danish: - hævelse i ansigtet, læberne, tungen eller halsen, vejtrækningsbesvær, lavt blodtryk,
English: In reproductive toxicity studies with topotecan in rats there was no effect on male or female fertility; however, in females super-ovulation and slightly increased pre-implantation loss were observed.
Danish: I reproduktionstoksiske forsøg af topotecan til rotter sås ingen effekt på fertiliteten hos hverken hanner eller hunner.
English: oC ± 2
Danish: Ελλάδα
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Topotecan Actavis 4 mg powder for concentrate for solution for infusion topotecan
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Topotecan Actavis 4 mg pulver til koncentrat til infusionsvæske, opløsning topotecan
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Topotecan Actavis 1 mg powder for concentrate for solution for infusion topotecan
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Topotecan Actavis 1 mg pulver til koncentrat til infusionsvæske, opløsning topotecan
English: Österreich Actavis GmbH
Danish: България Актавис ЕАД
English: Add 19 ml to give 20 ml 4 ml of 1 mg/ml topotecan solution Add 156 ml to give 160 ml Add 76 ml to give 80 ml
Danish: Tilsat 76 ml giver 80 ml
English: Rare side effects (may affect up to 1 in 1,000 people) - Swelling caused by fluid build-up (angioedema) e.g. around the eyes and lips as well as hands,
Danish: - Hævelser, der er forårsaget af væskeophobninger (angioødemer) f.eks. rundt om øjne og læber,
English: Chemical and physical stability of the solution obtained after dilution of the concentrate in sodium chloride 9 mg/ml (0.9 %) solution for injection or 50 mg/ml (5 %) glucose solution for infusion has been demonstrated for 4 hours at 25 ± 2°C, in normal lighting conditions.
Danish: Den fysiske og kemiske stabilitet af opløsningen efter fortynding af koncentratet i natriumchlorid 9 mg/ml (0,9 %) opløsning til injektion eller 50 mg/ml (5 %) glucoseopløsning til infusion er påvist i 4 timer ved 25 ± 2° C under normale lysforhold.
English: 9/l, and the haemoglobin level is ≥ 9 g/dl (after transfusion if necessary).
Danish: Topotecan bør ikke gives igen, medmindre neutrofiltallet er ≥ 1 x 109/l, trombocyttallet er ≥ 100 x 109/l og hæmoglobinniveauet er ≥ 9 g/dl (om nødvendigt efter transfusion).
English: Topotecan Actavis is not recommended in case of severe kidney impairment; - if you have liver problems.
Danish: Topotecan Actavis frarådes i tilfælde af alvorlig nedsat leverfunktion.
English: Additional adverse events were seen when topotecan was given in combination with cisplatin, however, these events were seen with cisplatin monotherapy and not attributable to topotecan.
Danish: Disse bivirkninger er dog tidligere set som følge af behandling med cisplatin-monoterapi og skyldes ikke topotecan.
English: In clinical trials,
Danish: Oversigt over indlægssedlen:
English: 1 ml of 1 mg/ml topotecan solution Add 39 ml to give 40 ml
Danish: 1 ml af 1 mg/ml topotecan opløsning
English: NAME OF THE MEDICINAL PRODUCT Topotecan Actavis 4 mg powder for concentrate for solution for infusion
Danish: LÆGEMIDLETS NAVN Topotecan Actavis 4 mg pulver til koncentrat til infusionsvæske, opløsning
English: NAME OF THE MEDICINAL PRODUCT Topotecan Actavis 1 mg powder for concentrate for solution for infusion
Danish: LÆGEMIDLETS NAVN Topotecan Actavis 1 mg pulver til koncentrat til infusionsvæske, opløsning
English: - Inflammation of the lining of the mouth and digestive tract.
Danish: - Betændelse i munden.
English: The median survival for patients treated with topotecan + BSC was 25.9 weeks (95 % C.I.
Danish: Medianoverlevelsen for patienter behandlet med topotecan + BSC var 25,9 uger (95 % CI 18,3; 31,6) sammenlignet med 13,9 uger (95 % CI 11,1; 18,6) for patienter, der fik BSC alene (p = 0,0104).
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Danish: Hvis du vil have yderligere oplysninger om Topotecan Actavis, skal du henvende dig til den lokale repræsentant:
English: No effects on male or female fertility have been observed in reproductive toxicity studies in rats (see section 5.3).
Danish: I reproduktionstoksiske forsøg med rotter er der ikke set påvirkning af fertilitet hos hverken hanner eller hunner.
English: Metabolism and nutrition disorders Very common:
Danish: Metabolisme og ernæring Meget almindelig: appetitmangel (kan være alvorlig)
English: Log rank p-value
Danish: Risikoforhold (95 % CI) Log rank p-værdi
English: The experience in children is limited, therefore no recommendation for treatment of paediatric patients with Topotecan Actavis can be given (see sections 5.1 and 5.2).
Danish: Topotecan Actavis bør ikke anvendes til pædiatriske patienter, da erfaring med børn er begrænset (se pkt.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 4 mg topotecan (as hydrochloride).
Danish: Hvert hætteglas indeholder 4 mg topotecan (som hydrochlorid).
English: sepsis Fatalities due to sepsis have been reported in patients treated with topotecan (see section 4.4) Blood and lymphatic system disorders Very common:
Danish: 1dødelige tilfælde af sepsis er rapporteret hos patienter i behandling med topotecan (se pkt.
English: Do not use Topotecan Actavis - if you are allergic to topotecan or any of the other ingredients of this medicine (listed in section 6); - if you are breast-feeding.
Danish: - hvis du er allergisk over for topotecan eller et af de øvrige indholdsstoffer i Topotecan Actavis
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 1 mg topotecan (as hydrochloride).
Danish: Hvert hætteglas indeholder 1 mg topotecan (som hydrochlorid) .
English: PHARMACEUTICAL FORM AND CONTENTS Powder for concentrate for solution for infusion.
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Pulver til koncentrat til infusionsvæske, opløsning 1 x 4 mg hætteglas
English: What Topotecan Actavis contains - The active substance is topotecan.
Danish: Aktivt stof: topotecan.
English: Hazard ratio (95 % C.I.)
Danish: Forskel i responserate (95 % CI)
English: Topotecan is contraindicated in patients who - have a history of severe hypersensitivity to the active substance or to any of the excipients listed in section 6.1 - are breast-feeding (see section 4.6) - already have severe bone marrow depression prior to starting first course, as evidenced by baseline neutrophils < 1.5 x 10
Danish: − før den første behandling indledes, lider af alvorlig knoglemarvssuppression, defineret som et baseline-neutrofiltal på < 1,5 x 109/l og/eller et trombocyttal på ≤ 100 x 109/l.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 1 mg topotecan (as hydrochloride).
Danish: Hvert hætteglas indeholder 1 mg topotecan (som hydrochlorid).
English: The study is to evaluate how the disease progresses in the two groups of children.
Danish: Studiet skal evaluere, hvordan sygdommen skrider frem i de to grupper af børn.
English: Orkambi received a marketing authorisation valid throughout the EU on 19 November 2015.
Danish: Orkambi fik en markedsføringstilladelse med gyldighed i hele EU den 19. november 2015.
English: The recommended dose depends on the age and weight of the patient.
Danish: Den anbefalede dosis afhænger af patientens alder og vægt.
English: Other information about Orkambi
Danish: Andre oplysninger om Orkambi
English: Further information on Orkambi can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Orkambi.
Danish: Yderligere information om Orkambi findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/Orkambi.
English: The tablets or granules are taken every 12 hours with fat-containing foods.
Danish: Tabletterne eller granulaterne udtages hver 12. time med fedtholdige fødevarer.
English: All children were treated with Orkambi.
Danish: Alle børn blev behandlet med Orkambi.
English: Overall the number of exacerbations was reduced by 39% when compared with placebo.
Danish: Samlet blev antallet af eksacerbationer mindsket med 39 % i forhold til placebo.
English: In total, these serious side effects occurred in more than 1 in 200 people during the clinical studies.
Danish: Samlet set forekom disse alvorlige bivirkninger hos flere end 1 ud af 200 patienter i løbet af de kliniske studier.
English: As for all medicines, data on the use of Orkambi are continuously monitored.
Danish: Som for alle lægemidler, er data vedrørende brug af Orkambi løbende overvåget.
English: The beneficial effects of Orkambi were smaller than expected for a medicine that treats the mechanism of the disease rather than its symptoms.
Danish: De gavnlige virkninger ved Orkambi var mindre end forventet for et lægemiddel, der behandler årsagen til sygdommen i stedet for dens symptomer.