FrancophonIA/ELRC3.0 huggingface dataset:
English: In an open-label randomised trial, a total of 322 previously untreated patients with follicular lymphoma were randomised to receive either CVP chemotherapy (cyclophosphamide 750 mg/m2, vincristine 1.4 mg/m2 up to a maximum of 2 mg on day 1, and prednisolone 40 mg/m2/day on days 1 -5) every 3 weeks for 8 cycles or rituximab 375 mg/m2 in combination with CVP (RCVP).
Danish: I et åbent, randomiseret studie blev 322 tidligere ubehandlede patienter med follikulært lymfom randomiseret til enten CVP-kemoterapi (cyklophosphamid 750 mg/m2, vincristin 1,4 mg/m2 op til maksimalt 2 mg på dag 1 og prednisolon 40 mg/m2 på dag 1-5) hver 3. uge i 8 serier eller til rituximab 375 mg/m2 i kombination med CVP (R-CVP).
English: (75%) and microscopic polyangiitis (24%) were enrolled and treated in an active-comparator, randomised, double-blind, multicentre, non-inferiority trial.
Danish: I alt 197 patienter i alderen 15 år og derover med svær, aktiv granulomatose med polyangiitis (75 %) eller mikroskopisk polyangiitis (24 %) blev inkluderet og behandlet i et randomiseret, dobbeltblindet, placebokontrolleret, non-inferioritets-multicenterstudie med aktiv kontrolgruppe.
English: At 24 months, estimates for overall survival were 68.2 % in the R-CHOP arm compared to 57.4 % in the CHOP arm. A subsequent analysis of the duration of overall survival, carried out with a median follow-up duration of 60 months, confirmed the benefit of R-CHOP over CHOP treatment (p=0.0071), representing a risk reduction of 32 %.
Danish: En efterfølgende analyse af længden af overlevelsen, udført med en median opfølgningsperiode på 60 måneder, bekræftede fordelene ved R-CHOP behandlingen i forhold til CHOP behandlingen (p = 0,0071), hvilket svarer til en risikoreduktion på 32 %.
English: IRRs in the GPA and MPA clinical trial were defined as any adverse event occurring within 24 hours of an infusion and considered to be infusion-related by investigators in the safety population.
Danish: Infusionsrelaterede reaktioner (IRR) i det kliniske studie hos patienter med granulomatose med polyangiitis (GPA) eller mikroskopisk polyangiitis (MPA) defineredes som enhver bivirkning, der opstod inden for 24 timer efter en infusion i sikkerhedspopulationen, og som af investigator blev anset som værende infusionsrelateret.
English: Clinical experience in non-Hodgkin's lymphoma and in chronic lymphocytic leukaemia
Danish: Klinisk erfaring ved non-Hodgkin-lymfom og kronisk lymfatisk leukæmi Follikulært lymfom
English: Table 3 Adverse drug reactions occurring at 6-months in ≥ 5% of patients receiving rituximab, and at a higher frequency than the comparator group, in the
Danish: Bivirkninger opstået hos ≥ 5 % af patienterne i behandling med rituximab, og med en højere frekvens end sammenligningsgruppen, i det pivotale kliniske studie ved måned 6.
English: Following second infusion, mean Cmax ranged from 183 to 198 µg/mL for the2 x 500 mg dose and ranged from 355 to 404 µg/mL for the 2 x 1000 mg dose.
Danish: Efter den anden infusion varierede gennemsnittet for Cmax fra 183 til 198 μg/ml for doseringen på 2 x 500 mg og fra 355 til 404 μg/ml for doseringen på 2 x 1.000 mg.
English: Table 8 Complete remission at 6-months by disease status Cyclophosphamide Difference (CI 95%)
Danish: Tabel 8 Fuldstændig remission ved måned 6 opgjort efter sygdomsstatus Rituximab
English: Rituzena is used for inducing remission in granulomatosis with polyangiitis (formerly called Wegener's granulomatosis) or microscopic polyangiitis, taken in combination with corticosteroids.
Danish: Når Rituzena gives i kombination med binyrebarkhormon, kan det fremkalde remission i sygdommen granulomatose med polyangiitis (blev tidligere kaldt Wegeners granulomatose) og mikroskopisk polyangiitis.
English: SPECIAL STORAGE CONDITIONS
Danish: 6.3 Opbevaringstid
English: angina pectoris, atrial fibrillation, heart failure, myocardial infarction atrial flutter toxic epidermal necrolysis (Lyell's
Danish: angina pectoris, atrieflimren, hjerteinsufficiens, myokardieinfarkt atrieflagren abdomen
English: However, a large component of inter-individual variability remained for CL2 after correction for CD19-positive cell counts and tumour lesion size.
Danish: Selvom der korrigeredes for CD-19 positive celletal og størrelsen af tumorbyrde, var der stadig store interindividuelle variationer i CL2 V1 varierede i forhold til kroppens overfladeareal og CHOP
English: Table 2 Summary of adverse drug reactions reported in clinical trials or during post marketing surveillance occurring in patients with rheumatoid arthritis receiving
Danish: Tabel 2 Opsummering af bivirkningsreaktioner hos patienter med reumatoid artrit, som fik rituximab i kliniske studier eller i forbindelse med post-marketing
English: If you are being treated for granulomatosis with polyangiitis or microscopic polyangiitis
Danish: c) Hvis du behandles for granulomatose med polyangiitis eller mikroskopisk polyangiitis
English: infusion site pain
Danish: smerter på infusionssted
English: Chronic lymphocytic leukaemia
Danish: Kronisk lymfatisk leukæmi (CLL)
English: This is a disease of the lymph tissue (part of the immune system) that affects B-Lymphocytes.
Danish: Non-Hodgkin-lymfom er en sygdom i lymfesystemet (en del af immunsystemet), der påvirker BRituzena kan anvendes alene eller sammen med kemoterapi.
English: Cmax following second infusion, was 207 µg/mL for the 2 x 500 mg dose and ranged from 377 to 386 µg/mL for the 2 x 1000 mg dose.
Danish: Efter den anden infusion var gennemsnittet for Cmax 270 μg/ml for doseringen på 2 x 500 mg og varierede fra 377 til 386 μg/ml for doseringen på 2 x 1.000 mg.
English: The ADRs listed in Table 3 were all adverse events which occurred at an incidence of ≥ 5% in the
Danish: Tabel over bivirkninger De bivirkninger, der opsummeres i tabel 3, forekom alle med en hyppighed ≥ 5 % i rituximab-gruppen.
English: The recommended dose of Rituzena monotherapy used as induction treatment for adult patients with stage III-IV follicular lymphoma who are chemoresistant or are in their second or subsequent relapse after chemotherapy is: 375 mg/m2 body surface area, administered as an intravenous infusion once
Danish: Den anbefalede dosis af Rituzena monoterapi til induktionsbehandling hos voksne patienter med grad III-IV follikulært lymfom, som er resistente over for behandling med kemoterapi eller som er i deres anden eller efterfølgende recidiv efter kemoterapi, er 375 mg/m2 legemsoverfladeareal, givet som intravenøs infusion én gang ugentligt i 4 uger.
English: If you are being treated for chronic lymphocytic leukaemia
Danish: Hvis du behandles for non-Hodgkin-lymfom eller kronisk lymfatisk leukæmi
English: Mean Cmax for serum rituximab following first infusion ranged from 157 to 171 µg/mL for 2 x 500 mg dose and ranged from 298 to 341 µg/mL for 2 x 1000 mg dose.
Danish: Efter første infusion varierede gennemsnittet for Cmax for serum-rituximab fra 157 til 171 μg/ml for doseringen på 2 x 500 mg og fra 298 til 341 μg/ml for doseringen på 2 x 1.000 mg.
English: Your doctor may decide to stop your Rituzena treatment if these reactions are
Danish: Hvis disse reaktioner er alvorlige, kan lægen vælge at stoppe behandlingen med Rituzena.
English: Mean Cmax for serum rituximab following first infusion was 170 to 175 µg/mL for 2 x 500 mg dose and 317 to 370 µg/mL for 2 x 1000 mg dose.
Danish: Efter første infusion varierede gennemsnittet for Cmax for serum-rituximab fra 170 til 175 μg/ml for doseringen på 2 x 500 mg og fra 317 til 370 μg/ml for doseringen på 2 x 1.000 mg.
English: Prophylaxis with adequate hydration and administration of uricostatics starting 48 hours prior to start of therapy is recommended for CLL patients to reduce the risk of tumour lysis syndrome.
Danish: For at nedsætte risikoen for tumorlysesyndrom hos CLL-patienter, bør der gives forebyggende behandling med adækvat hydrering og administration af urikosurika 48 timer før behandlingens start.
English: Rituzena is indicated for the treatment of patients with CD20 positive diffuse large B cell non-Hodgkin's lymphoma in combination with CHOP (cyclophosphamide, doxorubicin, vincristine,
Danish: Rituzena er, i kombination med CHOP-kemoterapi (cyclophosphamid, doxorubicin, vincristin og prednisolon), indiceret til behandling af patienter med CD20 positivt, diffust storcellet B-celle non
English: 3infusion related reactions (generalised oedema,
Danish: Lette til moderate infusionsrelaterede reaktioner (IRR'er) (pkt.
English: heart failure4
Danish: nyresvigt4
English: Cytokine release syndrome may be clinically indistinguishable
Danish: Cytokinfrigivelsessyndrom kan klinisk være umuligt at skelne fra akutte overfølsomhedsreaktioner.
English: A small number of cases of hepatitis B reactivation, some with fatal outcome, have been reported in granulomatosis with polyangiitis and microscopic polyangiitis patients receiving rituximab in the post
Danish: Der er efter markedsføring indberettet få tilfælde af hepatitis B-reaktivering, nogle med dødeligt udfald, blandt patienter med granulomatose med polyangiitis eller mikroskopisk polyangiitis behandlet
English: • Fever or cough all the time
Danish: • Feber eller vedvarende hoste
English: The incidence of ADRs of any grade was similar in
Danish: Hyppigheden af bivirkninger, uanset sværhedsgrad, var
English: Serious infections, including fatalities, can occur during therapy with rituximab (see section 4.8).Rituximab should not be administered to patients with an active, severe infection (e.g. tuberculosis, sepsis and opportunistic infections, see section 4.3) or severely immunocompromised patients (e.g. where levels of CD4 or CD8 are very low).
Danish: 4.3) eller til alvorligt immunkompromitterede patienter (for eksempel hvor CD4- eller CD8-niveauerne er meget lave).
English: In addition, there was no apparent effect of fludarabine and cyclophosphamide on the pharmacokinetics of rituximab.
Danish: Desuden påvirkede fludarabin og cyclophosphamid tilsyneladende
English: dysgeusia peripheral neuropathy, facial nerve cranial neuropathy, loss of other
Danish: depression, nervøsitet dysgeusi perifer neuropati facialisparese5
English: Rituzena 500 mg concentrate for solution for infusion
Danish: Rituzena 500 mg koncentrat til infusionsvæske, opløsning
English: If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before you are given Rituzena.
Danish: Hvis ét eller flere af ovenstående punkter gælder for dig (eller du er i tvivl), skal du kontakte lægen, apotekspersonalet eller sundhedspersonalet, inden du får Rituzena.
English: Keep this card with you for 2 years after This is because side effects can develop
Danish: Opbevar dette kort på dig i 2 år efter, at du har fået den sidste Rituzena-dosis.
English: Rituzena 100 mg concentrate for solution for infusion
Danish: Rituzena 100 mg koncentrat til infusionsvæske, opløsning
English: Also do not breast-feed for 12 months after your last treatment with Rituzena.
Danish: Da Rituzena udskilles i mælken, må du ikke amme, mens du er i behandling med Rituzena samt i 12 måneder efter din sidste dosis af Rituzena.
English: Patient subpopulations - rituximab combination therapy Elderly patients (≥ 65 years)
Danish: Specielle populationer - rituximab kombinationsterapi
English: Severe skin reactions such as Toxic Epidermal Necrolysis (Lyell's Syndrome) and Stevens-Johnson Syndrome, some with fatal outcome, have been reported (see section 4.8).
Danish: 4.8), såsom toksisk epidermal nekrolyse (Lyells syndrom) og Stevens-Johnsons syndrom, hvoraf nogle havde dødelig udgang.
English: General disorders and administration site conditions pyrexia, pruritus, urticaria, throat irritation, hot flush, hypotension, rhinitis, rigors, tachycardia, fatigue, oropharyngeal pain, peripheral bronchospasm, wheezing, laryngeal oedema, angioneurotic oedema, generalised pruritis, anaphylaxis, anaphylactoid reaction)
Danish: Systemorgan-klasser Meget almindelig Almindelig Ikke almindelig Sjælden Meget sjælden PML, reaktivering af hepatitis B sen neutropeni2 serumsygelignende reaktion infusions-relaterede reaktioner3 (generelt ødem, bronkospasme, hiven efter vejret, larynxødem angioødem, generaliseret kløe, anafylaksi, anafylaktoide reaktioner)
English: • flushing or redness of the skin
Danish: • ansigtsrødme eller rød hud
English: Re-treatment
Danish: Fuldstændig remission
English: • diarrhoea
Danish: • svimmelhed
English: The Patient Alert Card for Rituzena in non-oncology indications should contain the following key
Danish: Patientkortet for Rituzena for non-onkologiske indikationer skal indeholde følgende nøgle-elementer: • Nødvendigheden af altid at have kortet på sig og at vise kortet til alt behandlende
English: hours after infusion
Danish: Til intravenøs anvendelse efter fortynding
English: Malignancies
Danish: artralgier /
English: In patients treated with rituximab, the occurrence of pre-existing ischemic cardiac conditions becoming symptomatic, such as angina pectoris, has been observed, as well as atrial fibrillation and flutter.
Danish: Hos patienter der er blevet behandlet med rituximab, er der observeret udvikling af symptomer på tidligere eksisterende iskæmiske hjertelidelser,
English: Yeonsu-gu, Incheon, 22014, Republic of Korea Name and address of the manufacturers responsible for batch release Biotec House, Central Park, Western Avenue
Danish: Biotec House, Central Park, Western Avenue Bridgend Industrial Estate Bridgend, CF31 3RT, Storbritannien
English: You may be asked not to take these other medicines 12 hours before you are given Rituzena.
Danish: 12 timer inden, du får Rituzena.
English: If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
Danish: Hvis du ønsker yderligere oplysninger om dette lægemiddel, skal du henvende dig til den lokale repræsentant for indehaveren af markedsføringstilladelsen:
English: Each vial contains 500 mg of rituximab.
Danish: 1 hætteglas indeholder 500 mg rituximab
English: Each vial contains 100 mg of rituximab.
Danish: Et hætteglas indeholder 100 mg rituximab.
English: Contraindications for use in rheumatoid arthritis, granulomatosis with polyangiitis and microscopic
Danish: Svært immunkompromitterede patienter Kontraindikationer for anvendelse til reumatoid artrit, granulomatose med polyangiitis og
English: Dyspnoea Epistaxis Nasal congestion
Danish: interstitiel lungesygdom7
English: adjusted)
Danish: • Vægttab
English: Cough
Danish: Hrvatska
English: Study Treatment, N
Danish: Nyligt diagnosticerede n = 48
English: Description of selected adverse drug reactions
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER
English: Also some other medicines can
Danish: Din læge kan ordinere
English: vasculitis (predominatel y cutaneous), leukocytoclast ic vasculiti interstitial lung disease7
Danish: alvorlige kardielle sygdomme4 og hjerteinsufficiens4 og vasculitis (fortrinsvis kutan), leukocytoklastisk vasculitis bronchiolitis obliterans,
English: Tell your doctor immediately if you have a) If you are being treated for non-Hodgkin's Lymphoma or chronic lymphocytic leukaemia
Danish: a) Hvis du behandles for non-Hodgkin-lymfom
English: Rheumatoid arthritis
Danish: kemoterapi.
English: The incidence of ADRs of all grades and grade 3 /4 ADR was similar in elderly patients compared
Danish: Hyppigheden af bivirkninger, uanset sværhedsgrad, og hyppigheden af grad 3 og 4 bivirkninger var ens hos ældre, sammenlignet med yngre (< 65 år).
English: The authorisation was subsequently renewed.
Danish: Markedsføringstilladelsen blev efterfølgende fornyet.
English: The cream should be applied to the area twice daily for 7-14 days.
Danish: Cremen skal påføres området to gange dagligt i 7-14 dage.
English: The trial showed low level irritation, but no toxicity.
Danish: Undersøgelsen viste let irritation, men ingen toksicitet.
English: Lesions should be monitored closely for signs of infection.
Danish: Læsionerne skal overvåges nøje for tegn på infektion.
English: Pruban should not be used in puppies under 6 months of age.
Danish: Pruban må ikke anvendes til hvalpe, der er under 6 måneder.
English: Several studies were performed in rats, rabbits and dogs to examine the safety of Pruban.
Danish: Der blev gennemført en række undersøgelser hos rotter, kaniner og hunde for at undersøge Prubans sikkerhed.
English: A trial is humans had also been conducted.
Danish: Der er desuden gennemført en undersøgelse hos mennesker.
English: Other information about Pruban:
Danish: Andre oplysninger om Pruban:
English: Pruban reduces the inflammation of the skin locally.
Danish: Pruban reducerer betændelsen på huden lokalt.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) PRUBAN EPAR summary for the public
Danish: EUROPÆISK OFFENTLIG VURDERINGSRAPPORT (EPAR) PRUBAN EPAR - sammendrag for offentligheden
English: In case of diabetes mellitus, the potential systemic effects of the product may influence blood glucose concentrations.
Danish: I tilfælde af diabetes mellitus kan produktets potentielle systemiske effekt påvirke blodsukkerniveauet.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Pruban to Intervet International B.V. on 16 November 2000.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Pruban til Intervet International B.V.
English: In the studies of dogs suffering from acute moist dermatitis almost 80% of cases were cured or improved following treatment for 7 to 14 days.
Danish: I undersøgelserne blandt hunde med akut fugtig dermatitis sås i 80 % af tilfældene fuldstændig heling eller en bedring efter behandling i 7-14 dage.
English: The results of these studies are reflected in the contraindications.
Danish: Resultaterne af undersøgelserne fremgår af afsnittet om kontraindikationer.
English: Once the skin is irritated, an itch-scratch cycle starts and this may lead to lesions that are quite severe in appearance within a few hours.
Danish: Når først huden er irriteret, begynder en kløecyklus, hvor hunden vil klø sig selv, hvilket kan føre til læsioner, som ser alvorlige ud efter få timer.
English: Since glucocorticosteroids can slow growth, the use of the product in young, growing animals should be well controlled and large lesions should not be treated.
Danish: Da glukokortikosteroider kan forårsage forringet vækst, bør anvendelse til unge dyr i vækst overvåges nøje, og store læsioner bør ikke behandles.
English: Pruban should not be used in dogs with extensive, infected or ulcerated skin lesions or in animals suffering from Cushing's syndrome (hyperadrenocorticism).
Danish: Pruban må ikke anvendes til hunde med udbredte, inficerede eller ulcererede hudlæsioner eller til dyr, der lider af Cushings syndrom (hyperadrenokorticisme).
English: Resocortol butyrate is a corticosteroid.
Danish: Resocortol butyrat er et kortikosteroid.
English: Resocortol butyrate belongs to the group of glucocorticosteroids which have anti-inflammatory effects.
Danish: Resocortol butyrat tilhører gruppen af glucokortikosteroider, som har en antiinflammatorisk virkning.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Pruban exceeded the risks for the treatment of acute localised moist dermatitis in dogs, and recommended that Pruban be granted a market authorisation.
Danish: Udvalget for Veterinærlægemidler (CVMP) konkluderede, at fordelene ved Pruban opvejer risiciene ved behandling af akut, lokal fugtig dermatitis hos hunde, og anbefalede udstedelse af markedsføringstilladelse for Pruban.
English: Pruban is a white to off-white cream containing resocortol butyrate as the active substance.
Danish: Pruban er en hvid til råhvid creme, der indeholder det aktive stof resocortol butyrate.
English: What is the risk associated with Pruban?
Danish: Hvilken risiko er der forbundet med Pruban?
English: On rare occasions, hyperaemia of the treated area has been observed.
Danish: I sjældne tilfælde ses øget blodtilstrømning (hyperæmi) på det behandlede område.
English: The therapeutic use of these substances in humans has been recognised to induce local side effects such as skin thinning, skin weakness, delayed healing and secondary infections.
Danish: Det er konstateret, at den terapeutiske anvendelse af disse substanser til mennesker kan give lokale bivirkninger som tynd hud, skrøbelig hud, forlænget helingstid og sekundære infektioner.
English: Why has Pruban been approved?
Danish: Hvorfor blev Pruban godkendt?
English: What is Pruban?
Danish: Hvad er Pruban?
English: Most cases of acute moist dermatitis are due to complications of flea bite hypersensitivity, although they may also be caused by other ectoparasites, allergic skin diseases, anal sac problems or foreign bodies (such as grass awns).
Danish: Akut fugtig dermatitis skyldes oftest allergiske reaktioner på loppebid, men kan også skyldes andre ektoparasitter, hudallergisygdomme, analsækproblemer eller fremmedlegemer (såsom græsagn).
English: Do not use in dogs for breeding or in pregnant or lactating bitches.
Danish: Må ikke anvendes til avlsdyr eller til diegivende eller drægtige hunhunde.
English: What is Pruban used for?
Danish: Hvad anvendes Pruban til?
English: How has Pruban been studied?
Danish: Hvordan blev Pruban undersøgt?
English: Pruban is applied to the skin for the treatment of small areas of sudden onset moist irritated skin (acute moist dermatitis in dogs.
Danish: Pruban anvendes til behandling af lokal, pludseligt opstået fugtig dermatitis (akut fugtig dermatitis) hos hunde, og smøres på huden.
English: What benefit has Pruban shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, der er ved Pruban?
English: How does Pruban work?
Danish: Hvordan virker Pruban?
English: If this is the case, your doctor will tell you how to switch from that treatment to Sprimeo HCT.
Danish: Hvis dette er tilfældet, vil din læge fortælle dig, hvordan du kan skifte fra den behandling til Sprimeo HCT.
English: Do not use Sprimeo HCT after the expiry date which is stated on the carton.
Danish: Brug ikke Sprimeo HCT efter den udløbsdato, der står på pakningen.
English: Sprimeo HCT may have been prescribed to you because your previous treatment did not lower your blood pressure enough.
Danish: Sprimeo HCT kan være blevet ordineret til dig, fordi din tidligere behandling ikke sænkede dit blodtryk tilstrækkeligt.
English: Hydrochlorothiazide has been extensively prescribed for many years, frequently in higher doses than those contained in Sprimeo HCT.
Danish: Hydrochlorthiazid er blevet ordineret i stor udstrækning i mange år, ofte i højere dosis end indholdet i Sprimeo HCT.
English: Therefore the use of Sprimeo HCT with an NSAID requires caution, especially in elderly patients.
Danish: Anvendelse af Sprimeo HCT og et NSAID kræver derfor forsigtighed, især hos ældre patienter.
English: The safety of Sprimeo HCT has been evaluated in 9 clinical trials with more than 3,900 patients, including over 700 treated for over 6 months, and 190 for over 1 year.
Danish: Sprimeo HCT's sikkerhed er blevet evalueret i 9 kliniske forsøg med mere end 3.900 patienter, herunder over 700 behandlet i over 6 måneder og 190 i over 1 år.
English: Aliskiren/hydrochlorothiazide Over 3,900 hypertensive patients received Sprimeo HCT once daily in clinical trials.
Danish: Aliskiren/hydrochlorthiazid Mere end 3.900 hypertensive patienter har fået Sprimeo HCT en gang dagligt i kliniske forsøg.
English: These could be symptoms of an increase of pressure in your eye and can happen within hours to weeks of taking Sprimeo HCT.
Danish: Dette kan være symptomer på øget tryk i øjet og kan opstå inden for timer eller uger efter indtagelse af Sprimeo HCT.
English: The use of Sprimeo HCT in children and adolescents up to 18 years of age is not recommended.
Danish: Sprimeo HCT bør ikke anvendes til børn og unge op til 18 år.
English: Side effects reported in clinical studies for patients treated with Sprimeo HCT were: Common (affecting less than 1 in 10 patients):
Danish: Bivirkninger indberettet fra kliniske forsøg med patienter behandlet med Sprimeo HCT var: Almindelig (forekommer hos færre end 1 ud 10 patienter):