FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients treated with Pixuvri demonstrated 40% improvement in progression-free-survival compared to patients treated with comparator agents with 2.7 months longer median PFS ( hazard ratio (HR)=0.60, logrank p=0.005) (see Figure 1 below).
Danish: Patienter behandlet med Pixuvri udviste 40 % bedre progressionsfri overlevelse end patienter behandlet med komparatorstofferne og 2,7 måneders længere median progressionsfri overlevelse (PFS) (risikoforhold (HR) = 0,60, logrank p = 0,005) (se figur 1 nedenfor).
English: Theophylline: when co-administering the narrow-therapeutic index medicinal product theophylline, which is primarily metabolised by CYP1A2, there is a theoretical concern that this substrate may increase in concentration resulting in theophylline toxicity.
Danish: Theophyllin: Administration sammen med theophyllin, der er et lægemiddel med et smalt terapeutisk indeks og hovedsagelig metaboliseres af CYP1A2, kan teoretisk frygtes at medføre en stigning i koncentrationen af theophyllin med deraf følgende toksisk virkning.
English: Lactose monohydrate, sodium chloride, hydrochloric acid, sodium hydroxide.
Danish: Laktosemonohydrat, natriumchlorid, saltsyre, natriumhydroxid.
English: Any unused medicinal product or waste material, including materials used for reconstitution, dilution, and administration should be disposed of in accordance with local requirements.
Danish: Ikke anvendt lægemiddel samt affald heraf, herunder materialer anvendt til rekonstitution, fortynding og administration, skal bortskaffes i henhold til lokale retningslinjer.
English: Effects on hepatic or renal function were minimal.
Danish: Der var kun minimal påvirkning af lever- og nyrefunktion.
English: It appears as a dark blue powder which comes in vials containing 29 mg of pixantrone.
Danish: Det er et mørkeblåt pulver, der fås i hætteglas indeholdende 29 mg pixantron.
English: 5.2 Pharmacokinetic properties Absorption
Danish: 5.2 Farmakokinetiske egenskaber
English: Table 3 Adverse drug reactions reported related to Pixuvri in completed Pixuvri single agent studies by frequency System Organ Class
Danish: Tabel 3 Bivirkninger, der er indberettet at have sammenhæng med Pixuvri i afsluttede monoterapi-studier med Pixuvri, inddelt efter hyppighed Systemorganklasse
English: Immunisation may be ineffective when given during Pixuvri therapy.
Danish: Vaccinationer kan være virkningsløse, når de gives under behandling med Pixuvri.
English: Reconstituted and diluted solution
Danish: Rekonstitueret og fortyndet opløsning
English: Common Left ventricular dysfunction, cardiac disorder, cardiac failure congestive, bundle branch block, tachycardia Uncommon Arrhythmia
Danish: Almindelig Dysfunktion af venstre ventrikel, kardiel lidelse, kongestiv hjerteinsufficiens, grenblok, takykardi
English: Uncommon Esophagitis, oral paresthesia, rectal haemorrhage
Danish: Ikke almindelig Esofagitis, oral paræstesi, rektalblødning
English: The benefit of pixantrone treatment has not been established in patients when used as fifth line or greater chemotherapy in patients who are refractory to last therapy.
Danish: Fordelen ved behandling med pixantron er ikke klarlagt ved anvendelse som femtevalgs behandling eller derudover hos patienter med sygdom, der er refraktær over for den senest anvendte terapi.
English: The safety and efficacy of Pixuvri has not been established in patients with impaired renal function.
Danish: Pixuvris sikkerhed og virkning er ikke klarlagt hos patienter med nedsat leverfunktion.
English: Uncommon Hyperbilirubinaemia, hepatotoxicity
Danish: Ikke almindelig Hyperbilirubinæmi, hepatotoksicitet
English: Pixuvri is intended for administration as a slow intravenous infusion using an in-line filter (over a minimum of 60 minutes) only after reconstitution with 5 ml sodium chloride 9 mg/ml (0.9%) solution for injection and after further dilution with sodium chloride 9 mg/ml (0.9%) solution for injection to a final volume of 250 ml.
Danish: Pixuvri er beregnet til administration ved langsom intravenøs infusion gennem et in-line filter (i løbet af mindst 60 minutter), hvilket først må ske efter rekonstitution med 5 ml natriumklorid, injektionsvæske, opløsning, 9 mg/ml (0,9 %), og efterfølgende yderligere fortynding med natriumklorid 9 mg/ml, injektionsvæske, opløsning (0,9 %), til et endeligt volumen på 250 ml.
English: gastroenteritis - viral infections such as shingles or reactivation of other virus such as herpes in the mouth - nervousness, sleeplessness - loss of energy - dizziness, vertigo - dryness of the eye - numbness of the mouth - infection of the cornea - allergy to the medicine - decrease in blood calcium and sodium level; increase in blood uric acid level - inflammation or fluid accumulation around the lungs - runny nose - bleeding such as gut bleed, purple spots on body due to broken blood vessels - vein irritation - night sweats - irregular heartbeat - spontaneous erection - skin rash and/or ulceration - pain, swelling, weakness, stiffness in joints or muscles - decreased urinary output - loss of weight - increased bilirubin in blood or urine - inflammation of the gullet - pain in neck, back, extremities - nail infection - neoplasm (tumour) progression - new cancers of the bone marrow or blood, such as acute myeloid leukaemia (AML) or myelodysplastic syndrome (MDS) - liver damage - bone marrow failure - increased eosinophils in blood.
Danish: meningitis, mave- og tarmkatar - virusinfektioner som helvedesild eller reaktivering af andre virus som herpes i munden - nervøsitet, søvnløshed - manglende energi - svimmelhed - tørre øjne - følelsesløshed i munden - infektion af hornhinden - allergi over for lægemidlet - nedsat calcium- og natriumindhold i blodet; øget urinsyreindhold i blodet - betændelse eller væskeansamling omkring lungerne - løbende næse - blødning såsom tarmblødning og blå pletter på kroppen på grund af bristede blodkar - irritation af vener - nattesved - uregelmæssig hjerterytme - spontan erektion - udslæt og/eller sår i huden - smerte, hævelse, svaghed og stivhed i led eller muskler - nedsat urinmængde - vægttab - forhøjet bilirubin i blod eller urin - inflammation af spiserøret - smerter i nakke, ryg og lemmer - negleinfektion - fornyet vækst af svulster - nye kræftformer i knoglemarv eller blod, såsom akut myeloid leukæmi (AML) eller myelodysplastisk syndrom (MDS) - leverskade - svigt af knoglemarven - forhøjet antal eosinofile hvide blodlegemer
English: - Hypersensitivity to pixantrone dimaleate, or to any of the excipients listed in section 6.1 - Immunisation with live virus vaccines - Profound bone marrow suppression - Severe abnormal hepatic function.
Danish: 6.1 - vaccination med levende virusvacciner - dyb knoglemarvssuppression - svært abnorm leverfunktion.
English: NAME OF THE MEDICINAL PRODUCT Pixuvri 29 mg powder for concentrate for solution for infusion
Danish: LÆGEMIDLETS NAVN Pixuvri 29 mg pulver til koncentrat til infusionsvæske, opløsning
English: Reconstitution/preparation for intravenous administration Each single-use vial of Pixuvri contains pixantrone dimaleate equivalent to 29 mg pixantrone.
Danish: Rekonstitution/klargøring til intravenøs administration Hvert engangshætteglas med Pixuvri indeholder pixantrondimaleat svarende til 29 mg pixantron.
English: Bilirubin urine, blood phosphorus increased, blood urea increased, gamma-glutamyltransferase increased, neutrophil count increased, weight decreased
Danish: Bilirubin i urinen, forhøjet fosforindhold i blodet, forhøjet urinstof i blodet, forhøjet gammaglutamyltransferase, forhøjet neutrofiltal, vægttab
English: Reconstitution and dilution
Danish: Rekonstitution og fortynding
English: To be taken into consideration by patients on a controlled sodium diet.
Danish: For patienter på natrium- eller saltfattig diæt bør der tages hensyn hertil.
English: Τηλ: + 30 210 939 1000
Danish: ΣΕΡΒΙΕ ΕΛΛΑΣ ΦΑΡΜΑΚΕΥΤΙΚΗ ΕΠΕ Τηλ: + 30 210 939 1000
English: Any unused medicinal product or waste material including materials used for reconstitution, dilution, and administration should be disposed of in accordance with local requirements applicable to cytotoxic agents.
Danish: Ikke anvendt lægemiddel samt affald heraf, herunder materialer anvendt til rekonstitution, fortynding og administration, skal bortskaffes i henhold til lokale retningslinjer for cytotoksiske midler.
English: Pixuvri 29 mg powder for concentrate for solution for infusion pixantrone
Danish: Pixuvri 29 mg pulver til koncentrat til infusionsvæske, opløsning Pixantron
English: Other medicines and Pixuvri
Danish: Brug af anden medicin sammen med Pixuvri
English: Decreases in white and red blood cells and alterations in bone marrow, spleen, kidney, and testes were observed.
Danish: Der sås et fald i leukocyt- og erytrocyttallene og forandringer i knoglemarv, milt, nyrer og testes.
English: Pixuvri is an anticancer medicinal product that is harmful to cells; caution should be exercised in handling.
Danish: Pixuvri er et lægemiddel mod kræft og er cellebeskadigende.
English: < 1.0 - 0.5 x 109/l Delay treatment until recovery to platelet count ≥ 50 x 109/l and ANC** ≥ 1.0 x 109/l.
Danish: < 1,0 - 0,5 x 109/l Udsæt behandlingen indtil restituering af trombocyttallet ≥ 50 x 109/l og ANC** til ≥ 1,0 x 109/l.
English: Patients with impaired hepatic function
Danish: Patienter med nedsat leverfunktion
English: Frequency Undesirable effect
Danish: Hyppighed Bivirkning
English: Each vial contains 50 mg pixantrone dimaleate (equivalent to 29 mg pixantrone).
Danish: Hvert hætteglas indeholder 50 mg pixantrondimaleat (svarende til 29 mg pixantron).
English: Breast-feeding should be discontinued during treatment with Pixuvri.
Danish: Amning skal ophøre under behandling med Pixuvri.
English: Arthralgia, arthritis, back pain, muscular weakness, musculoskeletal chest pain, musculoskeletal stiffness, neck pain, pain in extremity
Danish: Artralgi, arthritis, rygsmerter, muskelsvaghed, muskuloskeletale brystsmerter, muskuloskeletal stivhed, nakkesmerter, ekstremitetssmerter
English: Pixuvri is used for the treatment of adult patients with multiply relapsed or refractory aggressive Non-Hodgkin Lymphomas.
Danish: Pixuvri anvendes til behandling af voksne patienter med multiple ikke-Hodgkins lymfomer ved tilbagefald eller manglende behandlingsvirkning.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 10 May 2012
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN
English: How much of Pixuvri is given
Danish: Hvilken dosis af Pixuvri gives der
English: Pharmacotherapeutic group: Antineoplastic agents, anthracyclines, and related substances.
Danish: Farmakoterapeutisk klassifikation: Antineoplastiske midler, cytostatika, antracykliner og beslægtede midler (topoisomerasehæmmere)
English: Delay treatment until recovery to platelet count ≥ 50 x 109/l and ANC** ≥ 1.0 x 109/l.
Danish: Udsæt behandlingen indtil restituering af trombocyttallet til ≥ 50 x 109/l og af ANC** til ≥ 1,0 x 109/l.
English: The reconstituted and diluted solution is stable for up to 24 hours at room temperature (15°C to 25°C) and daylight exposure in standard polyethylene (PE) infusion bags.
Danish: Den rekonstituerede og fortyndede opløsning er stabil i indtil 24 timer ved rumtemperatur (15 °C til 25 °C) i standard-infusionsposer af polyetylen (PE).
English: Active or dormant cardiovascular disease, prior therapy with anthracyclines or anthracenediones, prior or concurrent radiotherapy to the mediastinal area, or concurrent use of other cardiotoxic medicinal products may increase the risk of cardiac toxicity.
Danish: Risikoen for kardiotoksicitet kan være øget ved aktiv eller ikke aktiv kardiovaskulær sygdom, tidligere behandling med antracycliner eller antracendioner, tidligere eller samtidig stråleterapi mod mediastinum eller samtidig anvendelse af andre kardiotoksiske lægemidler.
English: ANC count
Danish: ANC-tal
English: Polyethersulfone 0.2 µm pore size in-line filters should be used during administration of the diluted Pixuvri solution.
Danish: Ved administration af den fortyndede opløsning af Pixuvri bør anvendes in-line filter med porestørrelse 0,2 µm af polyethersulfon.
English: Common Stomatitis, diarrhoea, constipation, abdominal pain,
Danish: Almindelig Stomatitis, diarré, obstipation, abdominalsmerter, mundtørhed, dyspepsi
English: How to use Pixuvri
Danish: Sådan skal du bruge Pixuvri
English: Common: may affect up to 1 in 10 people - infection such as lung infection, skin infections, infections with low white blood cells, thrush - fever - severe blood infection (sepsis)
Danish: Almindelig: kan påvirke op til 1 ud af 10 personer - infektioner såsom lungeinfektioner, hudinfektioner, infektioner forårsaget af lavt antal hvide blodlegemer, trøske - feber - alvorlig infektion i blodet (blodforgiftning) - smagsforstyrrelser - føleforstyrrelser i huden såsom følelsesløshed, snurren, stikken (paræstesi)
English: Pack size of 1 vial.
Danish: Pakningsstørrelse 1 hætteglas.
English: ANNEX II A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Danish: C. ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN D. BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL SIKKER OG
English: Moreover, unlike anthracyclines or anthracenediones, pixantrone directly alkylates DNA forming stable DNA adducts and cross-strand breaks.
Danish: I modsætning til godkendte antracycliner (doxorubicin m.fl.) og antracendioner (mitoxantron) er pixantron kun en svag hæmmer af topoisomerase II og alkylerer desuden DNA direkte ved dannelse af stabile DNA-addukter og spaltning på tværs af dobbeltstrengene.
English: Common Pallor, vein discolouration, hypotension Uncommon Vein disorder
Danish: Almindelig Bleghed, misfarvning af vener, hypotension Ikke almindelig Venesygdomme
English: - taste disturbances - abnormal sensations of the skin such as numbness, tingling, pricking (paraesthesia) - headache - sleepiness - tiredness - inflammation of the eyes (conjunctivitis) - diarrhoea - pain in the abdomen - inflammation and/or ulceration of the throat and the mouth - dry mouth, constipation, indigestion, loss of appetite - skin changes such as redness and itching of the skin, nail changes - damage to the heart, decrease in heart's ability to pump blood, blockage of electrical signals in your heart, uneven or fast heartbeat.
Danish: - hovedpine - søvnighed - træthed - betændelse af øjnene (konjunktivitis) - diarré - mavesmerter - inflammation og/eller sårdannelse i halsen og munden - mundtørhed, forstoppelse, fordøjelsesbesvær, appetitløshed - hudforandringer som rødme, kløe og negleforandringer - beskadigelse af hjertet, mindskelse af hjertets pumpekapacitet, blokering af elektriske signaler i hjertet, ujævn eller hurtig hjerterytme - for lavt blodtryk - misfarvning af vener, bleg hud - kortåndethed, hoste - blod i urinen - forhøjet proteinindhold i urinen - hævelse af ben, ankler eller andre legemsdele - knoglesmerter - brystsmerter - lavt indhold af fosfat i blodet - unormale blodprøver for lever- eller nyrefunktionen.
English: In some trials and publications, the recommended dose is based on the salt form (pixantrone dimaleate) However, the dose has to be adjusted before the start of each cycle based on nadir haematologic counts or maximum toxicity from the preceding cycle of therapy.
Danish: Før hver cyklus skal dosis dog justeres på grundlag af de hæmatologiske nadirparametre eller den maksimale toksicitet under foregående behandlingscyklus.
English: Common Conjunctivitis Uncommon Dry eye, keratitis
Danish: Almindelig Konjunktivitis Ikke almindelig Øjentørhed, keratitis
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING VIAL
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE HÆTTEGLAS
English: Thus, Pixuvri should be used with caution in patients with renal impairment.
Danish: Der bør derfor udvises forsigtighed ved anvendelse af Pixuvri hos patienter med nedsat nyrefunktion.
English: Comparator Agents
Danish: Komparatorstoffer
English: - if you have heart disease or uncontrolled high blood pressure, especially if you have ever been told you had heart failure or if you have had a heart attack within the last six months.
Danish: - hvis du fået vide, at du har et meget lavt antal hvide blodlegemer - hvis du har hjertesygdom eller ukontrolleret forhøjet blodtryk, specielt hvis du nogensinde har fået at vide, at du har hjerteinsufficiens, eller hvis du har haft et hjerteanfald inden for de seneste seks måneder - hvis du har en infektion - hvis du nogensinde er blevet behandlet for kræft - hvis du er på natriumfattig diæt - hvis du får andre lægemidler, der kan vekselvirke med Pixuvri (se "Brug af anden medicin sammen med Pixuvri").
English: Common Proteinuria, haematuria Uncommon Oliguria
Danish: Meget almindelig Kromaturi Almindelig Proteinuri, hæmaturi Ikke almindelig Oliguri
English: End-of-Study
Danish: Ved studiets slutning
English: Aseptically reconstitute each 29 mg vial with 5 ml of sodium chloride 9 mg/ml (0.9%) solution for injection.
Danish: Hvert 29 mg hætteglas rekonstitueres aseptisk med 5 ml natriumchlorid, 9 mg/ml (0,9 %), injektionsvæske, opløsning.
English: Pharmacokinetics of pixantrone proved to be linear in a broad range of doses, from 3 mg/m2 to 105 mg/m2.
Danish: Linearitet/non-linearitet Farmakokinetikken af pixantron er påvist at være lineær inden for et bredt dosisområde fra 3 mg/m2 til
English: Aseptically withdraw the volume needed for the required dose (based on 5.8 mg/ml concentration) and transfer to a 250 ml infusion bag of sodium chloride 9 mg/ml (0.9%) solution for injection.
Danish: Det nødvendige volumen til den ønskede dosis trækkes op med en aseptisk teknik (baseret på en koncentration på 5,8 mg/ml) og overføres til en 250 ml infusionspose med natriumchlorid, injektionsvæske, opløsning, 9 mg/ml (0,9 %).
English: Common Bone pain Uncommon
Danish: Almindelig Knoglesmerter Ikke almindelig
English: The Fisher exact test was used to compare proportions in the Pixuvri and comparator chemotherapeutic groups.
Danish: Til sammenligning af andelene i Pixuvri-gruppen og komparatorgruppen anvendtes Fishers eksakte test.
English: You might get infections more easily after you have been given Pixuvri.
Danish: Når du har fået Pixuvri, vil du muligvis lettere kunne få infektioner.
English: How to store Pixuvri
Danish: Opbevaring af Pixuvri
English: Pixuvri should be used with caution in patients with mild or moderate liver impairment.
Danish: Der bør derfor udvises forsigtighed ved anvendelse af Pixuvri hos patienter med let til moderat nedsat leverfunktion.
English: Using sterile procedures, withdraw the volume needed for the required dose (based on 5.8 mg/ml concentration) and further dilute with sodium chloride 9 mg/ml (0.9%) solution for injection to a final volume of 250 ml.
Danish: Det nødvendige volumen til den ønskede dosis trækkes op med aseptisk teknik (baseret på en koncentration på 5.8 mg/ml) og fortyndes yderligere med natriumchlorid, injektionsvæske, opløsning, 9 mg/ml (0,9 %) til et endeligt volumen på 250 ml.
English: In the clinical trial program, there has been one report of overdose with Pixuvri with no reported concomitant adverse events.
Danish: Der er blevet indberettet et tilfælde af overdosering uden indberetning af ledsagende bivirkninger med Pixuvri i det kliniske studieprogram.
English: What Pixuvri is and what it is used for What you need to know before you use Pixuvri How to use Pixuvri
Danish: Det skal du vide, før du begynder at bruge Pixuvri Sådan skal du bruge Pixuvri Bivirkninger
English: < 0.5 x 109/l
Danish: < 0,5 x 10
English: Common Fatigue, mucosal inflammation, pyrexia, chest pain,
Danish: Almindelig Træthed, slimhindeinflammation, pyreksi, brystsmerter, ødem
English: Using sterile procedures, reconstitute each 29 mg vial with 5 ml of sodium chloride 9 mg/ml (0.9%) solution for injection.
Danish: Hvert 29 mg hætteglas rekonstitueres sterilt med 5 ml natriumchlorid, 9 mg/ml (0,9 %), injektionsvæske, opløsning.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains pixantrone dimaleate equivalent to 29 mg pixantrone.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hvert hætteglas indeholder pixantrondimaleat svarende til 29 mg pixantron.
English: One vial contains pixantrone dimaleate equivalent to 29 mg pixantrone
Danish: Hvert hætteglas indeholder pixantrondimaleat svarende til 29 mg pixantron.
English: If on day 1 of any cycle the Absolute Neutrophil Count (ANC) is < 1.0 x 109/l or platelet count is
Danish: Hvis det absolutte neutrofiltal (ANC) på dag 1 af en vilkårlig cyklus er < 1,0 x 109/l, eller hvis trombocyttallet er < 75 x 109/l, anbefales behandlingen udsat, til ANC er restitueret til ≥ 1,0 x 109/l, og trombocyttallet til ≥ 75 x 109/l.
English: Based on in vitro studies, pixantrone was found to be a substrate for the membrane transport proteins P-gp/BRCP and OCT1 and agents which inhibit these transporters have the potential to decrease hepatic uptake and excretion efficiency of pixantrone.
Danish: In vitro-studier viste, at pixantron er substrat for membrantransportproteinerne P-gp/BRCP og OCT1.
English: Slight nephropathy was induced by Pixuvri.
Danish: Pixuvri forårsagede let nefropati.
English: Pixuvri does not contain anything to prevent the growth of bacteria and it is therefore recommended that it be used immediately after reconstitution.
Danish: Pixuvri indeholder ikke konserveringsstof til beskyttelse mod bakterier.
English: Do not breast-feed while you are being treated with Pixuvri.
Danish: Du må ikke amme, mens du er i behandling med Pixuvri.
English: Neutropenia, leukopenia, lymphopenia, anaemia, thrombocytopenia Common Febrile neutropenia, blood disorder Uncommon Bone marrow failure, eosinophilia
Danish: Almindelig Febril neutropeni, blodsygdomme Ikke almindelig Knoglemarvsdepression, eosinofili
English: Very common Asthenia
Danish: Meget almindelig Asteni
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and should not be longer than 24 hours at 2°C to 8°C.
Danish: Hvis det ikke anvendes straks, er brugeren ansvarlig for opbevaringstid og -betingelser.
English: oedema
Danish: Dosering
English: Common Erythema, nail disorder, pruritus Uncommon Night sweats, petechiae, rash macular, skin ulcer
Danish: Meget almindelig Ændret hudfarve, alopeci Almindelig Erytem, neglesygdomme, pruritus Ikke almindelig Nattesved, petekkier, makulært udslæt, hudsår
English: Hepatobiliary disorders
Danish: trombocytopeni
English: Do not use Pixuvri: - if you are allergic to pixantrone dimaleate or any of the other ingredients of this medicine
Danish: Brug ikke Pixuvri: hvis du er allergisk over for pixantrondimaleat eller et af de øvrige indholdsstoffer i Pixuvri (angivet i afsnit 6) hvis du for nylig har fået en vaccine hvis du har fået at vide, at du har vedholdende lavt antal røde blodlegemer, hvide blodlegemer og blodplader.
English: Common Taste disturbances, paraesthesia, headache,
Danish: Almindelig Smagsforstyrrelser, paræstesi, hovedpine, somnolens Ikke almindelig Svimmelhed, letargi
English: Posology
Danish: Komparator
English: Content (concentration) Package size
Danish: Indgivelsesvej Emballage Indhold (koncentration) Pakningsstørrelse
English: 1 vial
Danish: Særnavn
English: 120 capsules
Danish: 120 kapsler
English: Package size
Danish: Indhold (Koncentration) Paknings-størrelse
English: Capsule, soft bottle (HDPE)
Danish: EU/1/05/315/001 Aptivus 250 mg bløde kapsler oral anvendelse flaske (HDPE)
English: 100 mg/ml
Danish: EU/1/05/315/002 Aptivus 100 mg/ml oral opløsning oral anvendelse flaske (glass) 95 ml
English: Invented name Strength Pharmaceutical Form Route of Administration Packaging Content
Danish: Særnavn Styrke
English: Patients over 65 years of age and patients who have reduced liver or kidney function may need a lower starting dose of 5 mg per day.
Danish: Patienter over 65 år og patienter med nedsat lever- eller nyrefunktion skal muligvis have en lavere startdosis på 5 mg om dagen.