FrancophonIA/ELRC3.0 huggingface dataset:
English: Zalasta 20 mg tablets: available in boxes of 14, 28, 35, 56 and 70 tablets in blisters.
Danish: Zalasta 20 mg tabletter fås i pakker med 14, 28, 35, 56 og 70 tabletter i blister.
English: CARTON FOR ZALASTA 20 mg TABLETS
Danish: Karton - Zalasta 20 mg tabletter
English: Zalasta 7.5 mg orodispersible tablets Olanzapine
Danish: Zalasta 7,5 mg smeltetabletter olanzapin
English: Zalasta 7.5 mg orodispersible tablets Each orodispersible tablet contains 7.5 mg olanzapine.
Danish: Zalasta 7,5 mg smeltetablet Hver smeltetablet indeholder 7,5 mg olanzapin.
English: Zalasta 5 mg orodispersible tablets Tablets are round, slightly biconvex, yellow marbled tablets with possible individual spots.
Danish: Zalasta 5 mg smeltetablet Tabletterne er gule, runde, let bikonvekse, marmorerede tabletter med mulige, individuelle pletter.
English: Zalasta 20 mg tablets are: round, slightly biconvex, slightly yellow tablets with possible individual yellow spots and an inscription 20.
Danish: Zalasta 20 mg tabletter er runde, let bikonvekse, svagt gule med mulighed for individuelle gule prikker og påtrykt '20'.
English: Zalasta 15 mg orodispersible tablets Tablets are round, slightly biconvex, yellow marbled tablets with possible individual spots.
Danish: Zalasta 15 mg smeltetablet Tabletterne er gule, runde, let bikonvekse, marmorerede tabletter med mulige, individuelle pletter.
English: Zalasta 2.5 mg tablets Tablets are round, slightly biconvex, slightly yellow tablets with possible individual yellow spots.
Danish: Zalasta 2,5 mg tabletter Tabletterne er runde, let bikonvekse, svagt gule med mulighed for individuelle gule prikker.
English: BLISTER FOR ZALASTA 2.5 mg TABLETS
Danish: Blister - Zalasta 2,5 mg tabletter
English: CARTON FOR ZALASTA 10 mg TABLETS
Danish: Karton - Zalasta 10 mg tabletter
English: CARTON FOR ZALASTA 2.5 mg TABLETS
Danish: Karton - Zalasta 2,5 mg tabletter
English: Zalasta 20 mg orodispersible tablets Each orodispersible tablet contains 20 mg olanzapine.
Danish: Zalasta 20 mg smeltetablet Hver smeltetablet indeholder 20 mg olanzapin.
English: Zalasta 15 mg orodispersible tablets Olanzapine
Danish: Zalasta 15 mg smeltetabletter olanzapin
English: BLISTER FOR ZALASTA 15 mg TABLETS
Danish: Blister - Zalasta 15 mg tabletter
English: 14 orodispersible tablets 28 orodispersible tablets 35 orodispersible tablets 56 orodispersible tablets 70 orodispersible tablets
Danish: 14 smeltetabletter 28 smeltetabletter 35 smeltetabletter 56 smeltetabletter 70 smeltetabletter
English: Zalasta 10 mg orodispersible tablets Each orodispersible tablet contains 10 mg olanzapine.
Danish: Zalasta 10 mg smeltetablet Hver smeltetablet indeholder 10 mg olanzapin.
English: Zalasta 2.5 mg tablets: available in boxes of 14, 28, 35, 56 and 70 tablets in blister.
Danish: Zalasta 2,5 mg tabletter fås i pakker med 14, 28, 35, 56 og 70 tabletter i blister.
English: Zalasta 7.5 mg tablets: available in boxes of 14, 28, 35, 56 and 70 tablets in blisters.
Danish: Zalasta 7,5 mg tabletter fås i pakker med 14, 28, 35, 56 og 70 tabletter i blister.
English: BLISTER FOR ZALASTA 7.5 mg TABLETS
Danish: Blister - Zalasta 7,5 mg tabletter
English: Each orodispersible tablet contains 7.5 mg olanzapine.
Danish: 1 smeltetablet indeholder 7,5 mg olanzapin.
English: Zalasta 10 mg orodispersible tablets Olanzapine
Danish: Zalasta 10 mg smeltetabletter olanzapin
English: Zalasta 5 mg orodispersible tablets Zalasta 7.5 mg orodispersible tablets Zalasta 10 mg orodispersible tablets Zalasta 15 mg orodispersible tablets Zalasta 20 mg orodispersible tablets Olanzapine
Danish: Zalasta 5 mg, smeltetabletter Zalasta 7,5 mg, smeltetabletter Zalasta 10 mg, smeltetabletter Zalasta 15 mg, smeltetabletter Zalasta 20 mg, smeltetabletter olanzapin
English: Zalasta 5 mg tablets Blister (OPA/Alu/PVC, Alu-foil): 14, 28, 35, 56 or 70 tablets in a box.
Danish: Zalasta 5 mg tabletter Blister (OPA/Al/PVC, AI-folie): 14, 28, 35, 56 eller 70 tabletter i æske.
English: Zalasta 7.5 mg tablets Blister (OPA/Alu/PVC, Alu-foil): 14, 28, 35, 56 or 70 tablets in a box.
Danish: Zalasta 7,5 mg tabletter Blister (OPA/Al/PVC, AI-folie): 14, 28, 35, 56 eller 70 tabletter i æske.
English: Zalasta 15 mg tablets Blister (OPA/Alu/PVC, Alu-foil): 14, 28, 35, 56 or 70 tablets in a box.
Danish: Zalasta 15 mg tabletter Blister (OPA/Al/PVC, AI-folie): 14, 28, 35, 56 eller 70 tabletter i æske.
English: Zalasta 15 mg tablets: available in boxes of 14, 28, 35, 56 and 70 tablets in blisters.
Danish: Zalasta 15 mg tabletter fås i pakker med 14, 28, 35, 56 og 70 tabletter i blister.
English: Zalasta 20 mg orodispersible tablets Olanzapine
Danish: Zalasta 20 mg smeltetabletter olanzapin
English: Zalasta 10 mg tablets are: round, slightly biconvex, slightly yellow tablets with possible individual yellow spots and an inscription 10.
Danish: Zalasta 10 mg tabletter er runde, let bikonvekse, svagt gule med mulighed for individuelle gule prikker og påtrykt '10'.
English: Zalasta 2.5 mg tablets Blister (OPA/Alu/PVC, Alu-foil): 14, 28, 35, 56 or 70 tablets in a box.
Danish: Zalasta 2,5 mg tabletter Blister (OPA/Al/PVC, AI-folie): 14, 28, 35, 56 eller 70 tabletter i æske.
English: Zalasta 5 mg tablets: available in boxes of 14, 28, 35, 56 and 70 tablets in blisters.
Danish: Zalasta 5 mg tabletter fås i pakker med 14, 28, 35, 56 og 70 tabletter i blister.
English: EU/1/07/415/047 (14 orodispersible tablets) EU/1/07/415/048 (28 orodispersible tablets) EU/1/07/415/049 (35 orodispersible tablets) EU/1/07/415/050 (56 orodispersible tablets) EU/1/07/415/051 (70 orodispersible tablets)
Danish: EU/1/07/415/047 (14 smeltetabletter) EU/1/07/415/048 (28 smeltetabletter) EU/1/07/415/049 (35 smeltetabletter) EU/1/07/415/050 (56 smeltetabletter) EU/1/07/415/051 (70 smeltetabletter)
English: Each orodispersible tablet contains 15 mg olanzapine.
Danish: 1 smeltetablet indeholder 15 mg olanzapin.
English: Zalasta 5 mg orodispersible tablets Olanzapine
Danish: Zalasta 5 mg smeltetabletter olanzapin
English: CARTON FOR ZALASTA 20 mg ORODISPERSIBLE TABLETS
Danish: Karton - Zalasta 20 mg smeltetabletter
English: EU/1/07/415/042 (14 orodispersible tablets) EU/1/07/415/043 (28 orodispersible tablets) EU/1/07/415/044 (35 orodispersible tablets) EU/1/07/415/045 (56 orodispersible tablets) EU/1/07/415/046 (70 orodispersible tablets)
Danish: EU/1/07/415/042 (14 smeltetabletter) EU/1/07/415/043 (28 smeltetabletter) EU/1/07/415/044 (35 smeltetabletter) EU/1/07/415/045 (56 smeltetabletter) EU/1/07/415/046 (70 smeltetabletter)
English: orodispersible tablet
Danish: Udspilet abdomen
English: Each orodispersible tablet contains 10 mg olanzapine.
Danish: 1 smeltetablet indeholder 10 mg olanzapin.
English: Each orodispersible tablet contains 5 mg olanzapine.
Danish: 1 smeltetablet indeholder 5 mg olanzapin.
English: EU/1/07/415/052 (14 orodispersible tablets) EU/1/07/415/053 (28 orodispersible tablets) EU/1/07/415/054 (35 orodispersible tablets) EU/1/07/415/055 (56 orodispersible tablets) EU/1/07/415/056 (70 orodispersible tablets)
Danish: EU/1/07/415/052 (14 smeltetabletter) EU/1/07/415/053 (28 smeltetabletter) EU/1/07/415/054 (35 smeltetabletter) EU/1/07/415/055 (56 smeltetabletter) EU/1/07/415/056 (70 smeltetabletter)
English: CARTON FOR ZALASTA 7.5 mg TABLETS
Danish: Karton - Zalasta 7,5 mg tabletter
English: Zalasta 5 mg orodispersible tablets Each orodispersible tablet contains 5 mg olanzapine.
Danish: Zalasta 5 mg smeltetablet Hver smeltetablet indeholder 5 mg olanzapin.
English: CARTON FOR ZALASTA 10 mg ORODISPERSIBLE TABLETS
Danish: Karton - Zalasta 10 mg smeltetabletter
English: BLISTER FOR ZALASTA 10 mg ORODISPERSIBLE TABLETS
Danish: Blister - Zalasta 10 mg smeltetabletter
English: Each orodispersible tablet contains 20 mg olanzapine.
Danish: 1 smeltetablet indeholder 20 mg olanzapin.
English: CARTON FOR ZALASTA 15 mg TABLETS
Danish: Karton - Zalasta 15 mg tabletter
English: BLISTER FOR ZALASTA 5 mg TABLETS
Danish: Blister - Zalasta 5 mg tabletter
English: CARTON FOR ZALASTA 15 mg ORODISPERSIBLE TABLETS
Danish: Karton - Zalasta 15 mg smeltetabletter
English: Hepatic impairment
Danish: Svimmelhed Akatisi
English: Glucosuria Increased appetite
Danish: Forhøjede kolesterolniveauer Forhøjede glucoseniveauer Forhøjede triglyceridniveauer Glukosuri Øget appetit
English: BLISTER FOR ZALASTA 15 mg ORODISPERSIBLE TABLETS
Danish: Blister - Zalasta 15 mg smeltetabletter
English: BLISTER FOR ZALASTA 20 mg ORODISPERSIBLE TABLETS
Danish: Blister - Zalasta 20 mg smeltetabletter
English: EU/1/07/415/037 (14 orodispersible tablets) EU/1/07/415/038 (28 orodispersible tablets) EU/1/07/415/039 (35 orodispersible tablets) EU/1/07/415/040 (56 orodispersible tablets) EU/1/07/415/041 (70 orodispersible tablets)
Danish: EU/1/07/415/037 (14 smeltetabletter) EU/1/07/415/038 (28 smeltetabletter) EU/1/07/415/039 (35 smeltetabletter) EU/1/07/415/040 (56 smeltetabletter) EU/1/07/415/041 (70 smeltetabletter)
English: Zalasta 15 mg tablets are: round, slightly biconvex, slightly yellow tablets with possible individual yellow spots and an inscription 15.
Danish: Zalasta 15 mg tabletter er runde, let bikonvekse, svagt gule med mulighed for individuelle gule prikker og påtrykt '15'.
English: Zalasta 15 mg orodispersible tablets Each orodispersible tablet contains 15 mg olanzapine.
Danish: Zalasta 15 mg smeltetablet Hver smeltetablet indeholder 15 mg olanzapin.
English: Zalasta 5 mg tablets are: round, slightly biconvex, slightly yellow tablets with possible individual yellow spots and an inscription 5.
Danish: Zalasta 5 mg tabletter er runde, let bikonvekse, svagt gule med mulighed for individuelle gule prikker og påtrykt '5'.
English: EU/1/07/415/032 (14 orodispersible tablets) EU/1/07/415/033 (28 orodispersible tablets) EU/1/07/415/034 (35 orodispersible tablets) EU/1/07/415/035 (56 orodispersible tablets) EU/1/07/415/036 (70 orodispersible tablets)
Danish: EU/1/07/415/032 (14 smeltetabletter) EU/1/07/415/033 (28 smeltetabletter) EU/1/07/415/034 (35 smeltetabletter) EU/1/07/415/035 (56 smeltetabletter) EU/1/07/415/036 (70 smeltetabletter)
English: Further information on Jivi can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Jivi.
Danish: Yderligere information om Jivi findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/Jivi.
English: Other information about Jivi
Danish: Andre oplysninger om Jivi
English: As for all medicines, data on the use of Jivi are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brug af Jivi løbende overvåget.
English: Patients or their carers may be able to inject Jivi themselves at home once they have been trained appropriately.
Danish: Patienten eller dennes omsorgsperson kan selv injicere Jivi derhjemme efter at have fået passende oplæring.
English: For more information about using Jivi, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Jivi, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
English: What measures are being taken to ensure the safe and effective use of Jivi?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Jivi?
English: The most common side effect with Jivi (which may affect more than 1 in 10 people) is headache.
Danish: Den hyppigste bivirkning ved Jivi (som optræder hos mere end 1 ud af 10 patienter) er hovedpine.
English: Jivi can be used in adults and children from 12 years of age who have been treated previously.
Danish: Jivi kan anvendes hos voksne og børn i alderen 12 år og derover, som tidligere er blevet behandlet.
English: Since this could potentially cause problems especially in children below 12 years of age, Jivi is only approved for use in adults and children from 12 years of age.
Danish: Da dette potentielt kan medføre problemer, især hos børn under 12 år, er Jivi kun godkendt til voksne og børn i alderen 12 år og derover.
English: The European Medicines Agency decided that Jivi's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at fordelene ved Jivi opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: Side effects reported with Jivi are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Jivi vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
English: The dose and frequency of treatment depend on whether it is used to treat or prevent bleeding, as well as on the severity of the haemophilia, the extent and location of the bleeding and the patient's condition and weight.
Danish: Dosis og hyppighed af behandlingen afhænger af, om det skal anvendes til behandling eller til forebyggelse af blødning, sygdommens sværhedsgrad, blødningsomfang og sted samt patientens tilstand og vægt.
English: Hypersensitivity (allergic) reactions are common with Jivi (affecting up to 1 in 10 people) and may include swelling, burning and stinging at the injection site, chills, flushing, tingling, itchy rash, headache, hives, low blood pressure, lethargy, nausea and vomiting, restlessness, a rapid heartbeat, tightness of the chest and wheezing.
Danish: Allergiske reaktioner er almindelige ved Jivi (kan forekomme hos op til 1 ud af 10 patienter) og kan omfatte hævelse, brændende og stikkende fornemmelse på injektionsstedet, kulderystelser, rødme, prikkende fornemmelse, kløende udslæt, hovedpine, nældefeber, lavt blodtryk, sløvhed, kvalme og opkastning, rastløshed, hurtig hjerterytme, trykken for brystet og hvæsende vejrtrækning.
English: An overview of Jivi and why it is authorised in the EU
Danish: En oversigt over Jivi, og hvorfor det er godkendt i EU
English: What is Jivi and what is it used for?
Danish: Hvad er Jivi, og hvad anvendes det til?
English: Jivi was rated good or excellent at stopping bleeding in all surgeries.
Danish: Jivi blev bedømt som godt eller fremragende til at standse blødning i alle de kirurgiske indgreb.
English: Why is Jivi authorised in the EU?
Danish: Hvorfor blev Jivi godkendt i EU?
English: What are the risks associated with Jivi?
Danish: Hvilke risici er der forbundet med Jivi?
English: Jivi can only be obtained with a prescription and treatment should be under the supervision of a doctor who has experience in the treatment of haemophilia.
Danish: Jivi udleveres kun efter recept, og behandlingen bør iværksættes under opsyn af en læge med erfaring i behandling af hæmofili.
English: Jivi is given by injection into a vein.
Danish: Jivi indgives ved injektion i en blodåre.
English: The company that markets Jivi will conduct a study to investigate the potential effects of PEG accumulation in the choroid plexus of the brain and other organs.
Danish: Virksomheden, der markedsfører Jivi, skal gennemføre en undersøgelse af de mulige virkninger af PEG-ophobning i hjernens plexus choroideus og andre organer.
English: However, laboratory studies show that PEG, which is part of the active substance in Jivi, may accumulate in the body, including in a structure in the brain called the choroid plexus, following long-term treatment.
Danish: Laboratoriestudier viser imidlertid, at PEG, som indgår i det aktive stof i Jivi, kan ophobes i kroppen, herunder i en struktur i hjernen kaldet plexus choroideus, efter langvarig behandling.
English: The active substance in Jivi, damoctocog alfa pegol, works in the same way as the body's factor VIII.
Danish: Det aktive stof i Jivi, damoctocog alfa pegol, virker på samme måde som kroppens faktor VIII.
English: Jivi must not be used in patients with allergy to mouse or hamster proteins.
Danish: Jivi må ikke gives til patienter, som er allergiske over for muse- eller hamsterproteiner.
English: Jivi has been shown to be effective at reducing the number of bleeding episodes in patients with severe haemophilia and stopping bleeding when it occurs.
Danish: Jivi er påvist at være effektivt til at reducere antallet af blødningsepisoder hos patienter med svær hæmofili og standse blødninger, når de opstår.
English: In a second part of the study, 17 patients received Jivi to control bleeding during 20 major surgeries.
Danish: I en anden del af studiet fik 17 patienter Jivi til at kontrollere blødning under 20 større kirurgiske indgreb.
English: Studies show that Jivi is effective at preventing and treating bleeding episodes in patients with haemophilia A and its safety is comparable to that of other factor VIII products.
Danish: Undersøgelser viser, at Jivi er effektivt til at forebygge og behandle blødningsepisoder hos patienter med hæmofili A, og dets sikkerhed er sammenlignelig med andre faktor VIII-lægemidler.
English: Part of the active substance is a substance called polyethylene glycol, ‘PEG', which is included to help the medicine remain in the body for longer and thereby prolong its action.
Danish: En del af det aktive stof er et stof kaldet polyethylenglycol (PEG), der bidrager til, at lægemidlet bliver i kroppen længere og dermed virker længere.
English: It replaces the missing factor VIII, thereby helping the blood to clot and giving temporary control of the bleeding disorder.
Danish: Det erstatter den manglende faktor VIII og medvirker derfor til blodets størkning, så der opnås midlertidig kontrol med blødningsforstyrrelsen.
English: Following treatment with factor VIII products, including Jivi, some patients may develop inhibitors (antibodies) against factor VIII, preventing the medicine from working effectively and resulting in a loss of bleeding control.
Danish: Efter behandling med faktor VIII-lægemidler, herunder Jivi, kan nogle patienter danne antistoffer mod faktor VIII, hvilket medfører, at lægemidlet ikke længere virker effektivt, og at kontrollen med blødning svigter.
English: The 20 patients who were given Jivi for treating bleeding when it occurred had around 23 bleeding episodes a year.
Danish: De 20 patienter, der fik Jivi til behandling af blødninger, når de opstod, havde ca. 23 blødningsepisoder om året.
English: Jivi contains the active substance damoctocog alfa pegol.
Danish: Jivi indeholder det aktive stof damoctocog alfa pegol.
English: In a second study in 61 children aged below 12 years, Jivi given as preventive treatment reduced the number of bleeding episodes to around 3 episodes a year.
Danish: I et andet studie med 61 børn under 12 år reducerede Jivi givet som forebyggende behandling antallet af blødningsepisoder til ca. tre episoder om året.
English: Jivi is a medicine used to treat and prevent bleeding in patients with haemophilia A, an inherited bleeding disorder caused by lack of a clotting protein called factor VIII.
Danish: Jivi er et lægemiddel til behandling og forebyggelse af blødning hos patienter med den arvelige blødningsforstyrrelse hæmofili A, der skyldes mangel på blodstørkningsproteinet faktor VIII.
English: In a study of 134 patients from 12 years of age, 114 patients given Jivi as a preventive treatment had around 2 bleeding episodes per year.
Danish: I et studie med 134 patienter fra 12 år og opefter havde 114 patienter, som fik Jivi som forebyggende behandling, ca. to blødningsepisoder om året.
English: How is Jivi used?
Danish: Hvordan anvendes Jivi?
English: What benefits of Jivi have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Jivi?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Jivi have also been included in the summary of product characteristics and the package leaflet.
Danish: Der er desuden anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Jivi.
English: Patients with haemophilia A lack factor VIII, a protein needed for blood to clot and, as a result, they bleed readily.
Danish: Patienter med hæmofili A mangler faktor VIII, der er et protein, som er nødvendigt, for at blodet kan størkne, og de har derfor en øget tendens til blødning.
English: How does Jivi work?
Danish: Hvordan virker Jivi?
English: Annex I List of the names, pharmaceutical form, strength of the medicinal product, route of administration, Marketing Authorisation Holders in the Member States
Danish: BILAG I FORTEGNELSE OVER LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORM, STYRKE, INDGIVELSESVEJ, INDEHAVERE AF MARKEDSFØRINGSTILLADELSER I MEDLEMSSTATERNE
English: AstraZeneca A/S Arne Jacobsens Allé 13 2300 Köbenhavn S. Denmark
Danish: AstraZeneca A/S Arne Jacobsens Allé 13 2300 Köbenhavn S. Danmark
English: Theotokopoulou & Astronafton str 151 25 Maroussi
Danish: Grækenland AstraZeneca S.A. Theotokopoulou & Astronafton str 151 25 Maroussi
English: United Kingdom AstraZeneca UK Ltd. 600 Capability Green Luton LU1 3LU
Danish: Storbritannien AstraZeneca UK Ltd. 600 Capability Green Luton LU1 3LU
English: Belgium NV AstraZeneca SA Rue Egide van Ophemstraat 110, B-1180 Brussel Belgium
Danish: NV AstraZeneca SA Rue Egide van Ophemstraat 110, B-1180 Brussel Belgium
English: Gartunavagen, S-151 85 Sodertalje, Sweden
Danish: Astra Zeneca AB Gartunavagen, S-151 85 Sodertalje, Sweden
English: Czech Republic AstraZeneca UK Limited 2 Kingdom Street
Danish: AstraZeneca UK Limited 2 Kingdom Street London W2 6BD United Kingdom
English: Netherlands AstraZeneca BV Louis Pasteurlaan 5
Danish: AstraZeneca BV Louis Pasteurlaan 5 2719 EE Zoetermeer The Netherlands
English: London W2 6BD
Danish: 2300 Köbenhavn S.Danmark
English: This will take about 20 minutes
Danish: Det tager ca. 20 minutter
English: There are several reasons why this might happen, for example:
Danish: Der kan være flere årsager til dette, som f.eks.:
English: Continued follow-up is recommended.
Danish: Fortsat opfølgning anbefales.
English: You may need other treatment
Danish: Du kan have brug for anden behandling
English: It must never be given to anyone else.
Danish: Lægemidlet må aldrig gives til andre.
English: Interim registry reports shall be submitted every 2 years.
Danish: Der skal indsendes interime registerrapporter hvert andet år.
English: Patients can develop autoimmunity.
Danish: Patienterne kan udvikle autoimmunitet.
English: Survival n
Danish: Overlevelse n
English: MARKETING AUTHORISATION NUMBER(S) EU/1/16/1097/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/16/1097/001
English: No dose adjustment is expected to be required.
Danish: Dosisjustering forventes ikke at være nødvendig.
English: The presence of the transgene leads to increased expression of ADA.
Danish: Tilstedeværelse af transgenet medfører øget ekspression af ADA.
English: Patients should be closely monitored for potential catheter-related events.
Danish: Patienterne skal monitoreres nøje for potentielle kateterrelaterede hændelser.
English: Strimvelis should be administered once only.
Danish: Strimvelis skal kun administreres én gang.
English: They are all caused by the immune system becoming over-active and attacking the body's own tissues.
Danish: De skyldes alle, at immunsystemet bliver overaktivt og angriber kroppens egne væv.
English: For more information on what happens before and during treatment, see section 3, How Strimvelis is given.
Danish: For yderligere information om, hvad der sker inden og efter behandlingen, se afsnit 3, Sådan gives Strimvelis.
English: This information is provided in the Patient Alert Card.
Danish: Disse oplysninger er anført i patientoplysningskortet.
English: The infusion rate should not exceed 5 ml/kg/h.
Danish: Infusionshastigheden bør ikke overstige 5 ml/kg/t.
English: In some cases the patient may be unable to receive Strimvelis because of manufacturing issues.
Danish: I visse tilfælde vil patienten måske ikke kunne få Strimvelis på grund af fremstillingsproblemer.
English: Long-term follow-up
Danish: Langtidsopfølgning
English: The most commonly reported adverse reaction was pyrexia.
Danish: Den hyppigst rapporterede bivirkning var pyreksi.
English: Total cell number:
Danish: Samlet celleantal:
English: Strimvelis is given…
Danish: Strimvelis gives…
English: Strimvelis should only be administered after consultation with the patient and/or family.
Danish: Strimvelis bør kun administreres efter samtale med patienten og/eller dennes familie.
English: • weakness and pain in the feet and hands (Guillain-Barré syndrome)
Danish: • svaghed og smerter i fødder og hænder (Guillain-Barré-syndrom)