FrancophonIA/ELRC3.0 huggingface dataset:
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING VIAL LABEL (5 g)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE HÆTTEGLASSETS ETIKET (5 g)
English: Dose should be adjusted as necessary to achieve optimal protection against infections, an increase may be necessary in patients with persisting infection; a dose decrease can be considered when the patient remains infection free.
Danish: En dosisreduktion kan overvejes, når patienten forbliver infektionsfri.
English: • migraine
Danish: • migræne
English: The recommended dose is 0.2 - 0.4 g/kg every three to four weeks.
Danish: 4.1) Anbefalet dosis er 0,2-0,4 g/kg legemsvægt hver 3. til 4. uge.
English: ● lymphoedema
Danish: ● lymfeødem
English: What Flebogamma DIF is used for
Danish: Hvad anvendes Flebogamma DIF til
English: Device dislocation
Danish: Forskydning af anordning
English: Epistaxis, Nasal congestion, Upper-airway cough syndrome, Sinus pain, Dyspnoea
Danish: Epistaksis, tilstoppet næse, hostesyndrom i de øvre luftveje, sinussmerter, dyspnø
English: ● feeling jittery (nervousness)
Danish: ● følelse af anspændthed (nervøsitet)
English: Each vial of 50 ml contains: 5 g of human normal immunoglobulin Each vial of 100 ml contains: 10 g of human normal immunoglobulin Each vial of 200 ml contains: 20 g of human normal immunoglobulin
Danish: Hvert 50 ml hætteglas indeholder: 5 g humant normalt immunglobulin Hvert 100 ml hætteglas indeholder: 10 g humant normalt immunglobulin Hvert 200 ml hætteglas indeholder: 20 g humant normalt immunglobulin
English: ● nausea
Danish: • kvalme
English: Each vial of 50 ml contains: 5 g of human normal immunoglobulin Each vial of 100 ml contains: 10 g of human normal immunoglobulin Each vial of 200 ml contains: 20 g of human normal immunoglobulin Distribution of the IgG subclasses (approx. values): IgG1 66.6%
Danish: Hvert 50 ml hætteglas indeholder: 5 g humant normalt immunglobulin Hvert 100 ml hætteglas indeholder: 10 g humant normalt immunglobulin Hvert 200 ml hætteglas indeholder: 20 g humant normalt immunglobulin Fordeling af IgG underklasser (cirkaværdier):
English: PHARMACEUTICAL FORM AND CONTENTS Solution for infusion
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Infusionsvæske, opløsning
English: There is clinical evidence of an association between IVIg administration and thromboembolic events such as myocardial infarction, cerebral vascular accident (including stroke), pulmonary embolism and deep vein thromboses which is assumed to be related to a relative increase in blood viscosity through the high influx of immunoglobulin in at-risk patients.
Danish: apopleksi), lungeemboli og dyb venetrombose, som menes at hænge sammen med en relativ forøgelse af blodviskositeten grundet den høje tilførsel af immunglobulin til patienter i risikogruppen.
English: Urticaria
Danish: Ørepine
English: If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicine.
Danish: Kontakt lægen, før du får denne medicin, hvis lægen har fortalt dig, at du ikke tåler visse sukkerarter.
English: • injection site reactions (including injection site oedema, pain, pruritus and swelling)
Danish: • reaktioner på injektionsstedet (herunder ødem, smerter, kløe og hævelse på injektionsstedet)
English: Flebogamma DIF contains sodium
Danish: Flebogamma DIF indeholder natrium
English: Flebogamma DIF 50 mg/ml solution for infusion Human normal immunoglobulin (IVIg)
Danish: Flebogamma DIF 50 mg/ml infusionsvæske, opløsning Humant normalt immunglobulin (IVIg)
English: Abdominal pain, Abdominal pain upper, Diarrhoea, Flatulence
Danish: Mavesmerter, smerter i den øverste del af maven, diarré, flatulens
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (5 g, 10 g and 20 g)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE KARTON (5 g, 10 g og 20 g)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/07/404/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/07/404/001
English: MARKETING AUTHORISATION NUMBER(S) EU/1/07/404/006
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/07/404/006
English: Despite these measures, when medicines prepared from human blood or plasma are administered, the possibility of passing on infection cannot be totally excluded.
Danish: På trods af dette kan overførsel af smitte ikke fuldstændig udelukkes, når der anvendes lægemidler fremstillet ud fra blod eller plasma fra mennesker.
English: NAME OF THE MEDICINAL PRODUCT Flebogamma DIF 50 mg/ml solution for infusion
Danish: LÆGEMIDLETS NAVN Flebogamma DIF 50 mg/ml infusionsvæske, opløsning.
English: Flebogamma DIF 100 mg/ml solution for infusion Human normal immunoglobulin (IVIg)
Danish: Flebogamma DIF 100 mg/ml infusionsvæske, opløsning Humant normalt immunglobulin (IVIg)
English: 1 g/kg or
Danish: 2 g/kg legemsvægt
English: ● dyspnoea (difficulty in breathing)
Danish: ● vejrtrækningsbesvær (dyspnø)
English: There is reassuring clinical experience regarding the lack of hepatitis A or parvovirus B19 transmission with immunoglobulins and it is also assumed that the antibody content makes an important contribution to viral safety.
Danish: Kliniske erfaringer tyder på, at hepatitis A eller parvovirus B19 ikke overføres med immunglobuliner.
English: Haemolytic anaemia
Danish: hæmolytisk transfusionskrævende anæmi
English: Back pain, Myalgia
Danish: Rygsmerter, myalgi
English: NAME OF THE MEDICINAL PRODUCT Flebogamma DIF 100 mg/ml solution for infusion
Danish: LÆGEMIDLETS NAVN Flebogamma DIF 100 mg/ml infusionsvæske, opløsning.
English: Despite this, when medicinal products prepared from human blood or plasma are administered, the possibility of transmitting infective agents cannot be totally excluded.
Danish: På trods af dette kan overførsel af smitstof ikke fuldstændig udelukkes, når der anvendes præparater fremstillet ud fra humant blod eller plasma.
English: ● blood pressure increased or decreased
Danish: ● blodtrykstigning eller blodtryksfald
English: ● musculoskeletal discomfort
Danish: ● muskelkramper og muskelstramhed
English: Flebogamma DIF 50 mg/ml should be infused intravenously at an initial rate of 0.01 - 0.02 ml/kg/min for the first thirty minutes.
Danish: Flebogamma DIF 50 mg/ml skal infunderes intravenøst med en initial infusionshastighed på 0,01 - 0,02 ml/kg/minut i de første 30 minutter.
English: The ability to drive and operate machines may be impaired by some adverse reactions, such as dizziness, associated with Flebogamma DIF.
Danish: Visse bivirkninger, der er forbundet med Flebogamma DIF, som fx svimmelhed, kan påvirke evnen til at føre motorkøretøj og betjene maskiner.
English: Other side effects
Danish: Bivirkninger
English: STATEMENT OF ACTIVE SUBSTANCE(S) One ml contains 100 mg of human normal immunoglobulin (IVIg) of which at least 97% is IgG.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER En ml indeholder 100 mg af humant, normalt immunglobulin (IVIg), hvoraf mindst 97 % er IgG.
English: ● abdominal discomfort and distension
Danish: ● ubehag i maven og udspiling af maven
English: STATEMENT OF ACTIVE SUBSTANCE(S) One ml contains 50 mg of human normal immunoglobulin (IVIg) of which at least 97% is IgG.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER 1 ml indeholder 50 mg humant normalt immunglobulin (IVIg), hvoraf mindst 97 % er IgG.
English: Flebogamma DIF 100 mg/ml should be infused intravenously at an initial rate of 0.01 ml/kg/min for the first thirty minutes.
Danish: Flebogamma DIF 100 mg/ml skal infunderes intravenøst med en initial infusionshastighed på 0,01 ml/kg/minut i de første 30 minutter.
English: ● pain
Danish: • smerter
English: ● heart rate increased
Danish: ● øget hjertefrekvens (puls)
English: Abdominal pain upper, Abdominal pain, Diarrhoea, Nausea, Vomiting Common
Danish: Smerter i den øverste del af maven, mavesmerter, diarré, kvalme, opkastning
English: If tolerated, advance to 0.02 ml/kg/min for the second 30 minutes.
Danish: Hvis patienten tåler dette, øges til 0,02 ml/kg/min i de næste 30 minutter.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING VIAL LABEL (10 g and 20 g)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE HÆTTEGLASSETS ETIKET (10 g og 20 g)
English: Bronchitis, Wheezing
Danish: Svimmelhed, rysten
English: ● epistaxis (haemorrhage from the nose)
Danish: ● løbende næse (nasofaryngitis)
English: ● haematemesis (vomiting blood)
Danish: ● opkastning af blod (hæmatemese)
English: Flebogamma DIF should be infused intravenously at an initial rate of 0.01 ml/kg/min for the first thirty minutes.
Danish: Flebogamma DIF skal infunderes intravenøst med en initial hastighed på 0,01 ml/kg/minut i de første 30 minutter.
English: One ml contains 50 mg of human normal immunoglobulin (IVIg) of which at least 97% is IgG.
Danish: 1 ml indeholder 50 mg humant normalt immunglobulin (IVIg), hvoraf mindst 97 % er IgG.
English: • blood pressure decreased
Danish: • fald i blodtrykket
English: ● thrombosis
Danish: Tromboemboli
English: ● haemoglobin decreased
Danish: ● nedsat hæmoglobin
English: One ml contains 100 mg of human normal immunoglobulin (IVIg) of which at least 97% is IgG.
Danish: 1 ml indeholder 100 mg humant normalt immunglobulin (IVIg), hvoraf mindst 97 % er IgG.
English: One ml contains 100 mg of human normal immunoglobulin, of which at least 97% is IgG.
Danish: 1 ml indeholder 100 mg humant normalt immunglobulin, hvoraf mindst 97 % er IgG.
English: One ml contains 50 mg of human normal immunoglobulin, of which at least 97% is IgG.
Danish: 1 ml indeholder 50 mg humant normalt immunglobulin, hvoraf mindst 97 % er IgG.
English: • asthenia (fatigue)
Danish: ● svimmelhed (transportsyge)
English: The dose in children is not considered to be different to that of adults as it will be given depending on the illness and body weight of the children.
Danish: Da dosis gives efter kropsvægt og efter den foreliggende tilstand, betragtes dosis til børn ikke som værende anderledes end den til voksne.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING VIAL LABEL (5 g, 10 g and 20 g)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE HÆTTEGLASSETS ETIKET (5 g, 10 g og 20 g)
English: Abdominal discomfort, Abdominal distension, Dry mouth, Haematemesis Uncommon
Danish: Ubehag i maven, abdominal udspiling, mundtørhed, hæmatemese
English: • history of vascular disease or thrombosis
Danish: • tidligere karsygdom eller blodprop
English: Dizziness
Danish: Kvalme
English: 0.2 - 0.8 g/kg every 3 - 4 weeks
Danish: Vedligeholdelsesdosis: 0,2 - 0,8 g/kg legemsvægt hver 3. til 4. uge
English: Wheezing
Danish: • kløe
English: - Secondary immunodeficiencies (SID) in patients who suffer from severe or recurrent infections,
Danish: - hos patienter med en ubehandlet infektion eller underliggende, kronisk inflammation
English: What Flebogamma DIF contains
Danish: Flebogamma DIF indeholder:
English: • pruritus (itching)
Danish: • ledsmerter (artralgi)
English: ● limb discomfort
Danish: ● ubehag i lemmerne
English: Flebogamma DIF should be infused intravenously at an initial rate of 0.01 - 0.02 ml/kg/min for the first thirty minutes.
Danish: Flebogamma DIF skal infunderes intravenøst med en initial infusionshastighed på 0,01-0,02 ml/kg/minut i de første 30 minutter.
English: Uncommon Uncommon
Danish: Ikke almindelig Ikke almindelig
English: ineffective antimicrobial treatment and either proven specific antibody failure (PSAF)* or serum IgG level of <4 g/l *PSAF= failure to mount at least a 2-fold rise in IgG antibody titre to pneumococcal polysaccharide and polypeptide antigen vaccines
Danish: Substitutionsterapi hos voksne, børn og unge (2-18 år) ved: - Primære immundefektsyndromer (PID) med nedsat antistofproduktion - Sekundære immundefekter (SID) hos patienter, der lider af svære eller tilbagevendende infektioner, ineffektiv antimikrobiel behandling og enten påvist specifikt antistofsvigt (proven specific antibody failure, PSAF)* eller serum-IgG-niveau på <4 g/l *PSAF= opnåede ikke mindst en fordobling i IgG-antistoftiter over for pneumokok-polysaccharid og polypeptid-antigenvacciner
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Flebogamma DIF 50 mg/ml solution for infusion Human normal immunoglobulin (IVIg)
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Flebogamma DIF 50 mg/ml infusionsvæske, opløsning.
English: ● erythema (redness of the skin)
Danish: ● ledsmerter (artralgi)
English: If you use more Flebogamma DIF than you should
Danish: Hvis du har brugt for meget Flebogamma DIF
English: Musculoskeletal and connective tissue disorders
Danish: Injektionsfrekvens legemsvægt acetylsalicylsyre
English: Ear and labyrinth disorders Vertigo
Danish: Øre og labyrint
English: How to use Flebogamma DIF
Danish: Sådan skal du bruge Flebogamma DIF
English: Dose
Danish: Meget
English: Conjunctivitis, Maculopathy, Vision blurred
Danish: Conjunctivitis, makulopati, sløret syn Ikke almindelig
English: Limb discomfort, Muscle spasms, Muscle tightness, Neck pain, Pain in extremity
Danish: Utilpashed i lemmer, muskelkramper, muskelstramhed, nakkesmerter, smerter i lemmer
English: This is a summary of the European public assessment report (EPAR) for Prevymis.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Prevymis.
English: Other information about Prevymis
Danish: Andre oplysninger om Prevymis
English: If ciclosporin (a medicine that prevents rejection of the transplant) is used at the same time, the Prevymis dose is reduced to 240 mg once daily.
Danish: Hvis ciclosporin (et lægemiddel, der forebygger afstødning af transplantatet) tages samtidigt, reduceres Prevymis-dosen til 240 mg én gang dagligt.
English: The European Medicines Agency therefore decided that Prevymis's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede derfor, at fordelene ved Prevymis opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: All patients in this study were CMV seropositive, meaning they had come into contact with the virus before and were likely to be carrying it in an inactive form.
Danish: Alle patienter i denne undersøgelse var cytomegalovirus-seropositive, hvilket betyder, at de havde været i kontakt med virussen før og sandsynligvis havde den i en ikke-aktiv form.
English: What measures are being taken to ensure the safe and effective use of Prevymis?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Prevymis?
English: Of the patients receiving Prevymis, about 38% (122 out of 325) had signs of CMV becoming active 24 weeks after the stem cell transplant compared with 61% of the patients (103 out of 170) receiving placebo.
Danish: Blandt de patienter, der fik Prevymis, havde ca. 38 % (122 ud af 325) tegn på aktivering af cytomegalovirus 24 uger efter stamcelletransplantationen sammenholdt med 61 % (103 ud af 170) blandt de patienter, der fik placebo.
English: Many people have CMV in their body but it is usually inactive and it does not cause harm.
Danish: Mange mennesker har cytomegalovirus i kroppen, men det er typisk inaktiveret og medfører ingen skade.
English: The combination of Prevymis and ciclosporin must not be used with dabigatran, atorvastatin, pitavastatin, rosuvastatin and simvastatin.
Danish: Kombinationen af Prevymis og ciclosporin må ikke anvendes sammen med dabigatran, atorvastatin, pitavastatin, rosuvastatin og simvastatin.
English: The usual recommended dose by mouth or as an infusion is 480 mg once daily.
Danish: Den sædvanlige anbefalede dosis er 480 mg én gang dagligt taget gennem munden eller som infusion.
English: Prevymis contains the active substance letermovir.
Danish: Prevymis indeholder det aktive stof letermovir.
English: Terminase is involved in packaging the DNA in the protein shells of the virus.
Danish: Terminase medvirker til at pakke dna'et ind i virussens proteinskaller.
English: The most common side effects with Prevymis (which may affect up to 1 in 10 people) are nausea (feeling sick), diarrhoea and vomiting.
Danish: De hyppigste bivirkninger ved Prevymis (som optræder hos op til 1 ud af 10 patienter) er kvalme, diarré og opkastning.
English: The full EPAR for Prevymis can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Prevymis findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Because the number of patients with CMV disease is low, the disease is considered ‘rare', and Prevymis was designated an ‘orphan medicine' (a medicine used in rare diseases) on 15 April 2011.
Danish: Da antallet af patienter med cytomegalovirus er lavt, anses sygdommen for at være "sjælden", og letermovir blev udpeget som "lægemiddel til sjældne sygdomme" den 15. april 2011.
English: Why is Prevymis approved?
Danish: Hvorfor blev Prevymis godkendt?
English: For CMV to multiply, its genetic material (DNA) needs to be copied and packaged into protein shells to produce more viruses that can then infect other cells.
Danish: For at cytomegalovirus kan formere sig, skal dets genetiske materiale (dna) kopieres og pakkes ind i proteinskaller, så det kan producere mere virus, som så kan inficere andre celler.
English: What is Prevymis and what is it used for?
Danish: Hvad er Prevymis, og hvad anvendes det til?
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Prevymis can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Danish: Sammendraget af udtalelsen fra Udvalget for Lægemidler til Sjældne Sygdomme om Prevymis findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: For more information about treatment with Prevymis, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Prevymis, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Prevymis must not be used together with the medicine pimozide, or ergot medicines such as ergotamine and dihydroergotamine.
Danish: Prevymis må ikke anvendes sammen med lægemidlet pimozid eller ergot-lægemidler som f.eks. ergotamin og dihydroergotamin.
English: It has few side effects unlike other medicines used for the treatment of CMV disease which can damage bone marrow and affect blood cells.
Danish: Det har få bivirkninger i modsætning til andre lægemidler, der anvendes i behandlingen af cytomegalovirus, som kan beskadige knoglemarv og påvirke blodlegemer.
English: Treatment with Prevymis is started on the day of the transplant or on any day up to 28 days afterwards and it is continued for 100 days after the transplantation; longer treatment may be considered in some patients.
Danish: Behandling med Prevymis iværksættes på dagen for transplantationen eller i løbet af de første 28 dage bagefter, og den fortsættes i 100 dage efter transplantationen.
English: However, CMV can become active in patients whose immune system is weakened such as those having stem cell transplants.
Danish: Cytomegalovirus kan imidlertid blive aktiveret hos patienter, hvis immunsystem er svækket, f.eks. patienter, der har fået en stamcelletransplantation.
English: Letermovir, the active substance in Prevymis, blocks a virus enzyme called ‘terminase'.
Danish: Letermovir, der er det aktive stof i Prevymis, blokerer et virusenzym, der hedder terminase.
English: By blocking the enzyme, the medicine prevents viruses from developing properly, so that CMV cannot multiply and infect other cells.
Danish: Ved at blokere enzymet forhindrer lægemidlet virussen i at udvikle sig normalt, og så kan cytomegalovirussen ikke formere sig og inficere andre celler.
English: It is not intended to provide practical advice on how to use Prevymis.
Danish: Det er ikke en praktisk vejledning i, hvordan Prevymis bør anvendes.
English: What are the risks associated with Prevymis?
Danish: Hvilke risici er der forbundet med Prevymis?
English: For the full list of side effects reported with Prevymis, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Prevymis fremgår af indlægssedlen.
English: This is expected to prevent CMV disease in transplant recipients who already have CMV in their body.
Danish: Dette forventes at forhindre cytomegalovirus hos transplantationsmodtagere, som allerede har cytomegalovirus i kroppen.
English: Prevymis is available as tablets to be taken by mouth and as a concentrate that is made up into a solution for infusion (drip) into a vein and given over about an hour.
Danish: Prevymis fås som tabletter, der tages gennem munden, og som koncentrat, der opblandes til en væske, der indgives som infusion (drop) i en blodåre over en time.
English: Prevymis can only be obtained with a prescription, and treatment should be started by a doctor experienced in managing patients who have had an allogeneic haematopoietic stem cell transplant.
Danish: Prevymis udleveres kun efter recept, og behandlingen bør iværksættes af en læge med erfaring i behandling af patienter, der har fået en allogen hæmatopoietisk stamcelletransplantation.
English: A main study involving 570 adults found Prevymis was more effective than placebo (a dummy treatment) in preventing CMV infection after allogeneic haematopoietic stem cell transplantation.
Danish: Det er i en hovedundersøgelse med 570 voksne påvist, at Prevymis var mere effektivt end placebo (ikke-aktivt stof) til at forebygge cytomegalovirus-infektion efter allogen hæmatopoietisk stamcelletransplantation.
English: Allogeneic haematopoietic stem cell transplantation involves using stem cells from a donor to replace the recipient's bone marrow cells to form new bone marrow that produces healthy blood cells.
Danish: Allogen hæmatopoietisk stamcelletransplantation går ud på at erstatte en modtagers knoglemarvsceller med stamceller fra en donor, således at der er ny knoglemarv, som kan danne nye raske blodceller.
English: Doctors should consider official guidance on the use of antiviral medicines when using Prevymis.
Danish: Læger, der ordinerer Prevymis, bør tage højde for officielle behandlingsvejledninger for brugen af antivirale lægemidler.
English: Prevymis is an antiviral medicine used to prevent illness caused by cytomegalovirus (CMV) in adults having an allogeneic haematopoietic stem cell transplant to replace their bone marrow.
Danish: Prevymis er et antiviralt lægemiddel, der anvendes til at forebygge sygdom forårsaget af cytomegalovirus (CMV) hos voksne, der har fået en allogen hæmatopoietisk stamcelletransplantation for at udskifte deres knoglemarv.
English: How is Prevymis used?
Danish: Hvordan anvendes Prevymis?
English: For practical information about using Prevymis, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Prevymis, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Prevymis have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Prevymis.
English: What benefits of Prevymis have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Prevymis?
English: How does Prevymis work?
Danish: Hvordan virker Prevymis?
English: Prevymis is effective in preventing CMV from becoming active and causing disease in adult recipients of a stem cell transplantation to replace the bone marrow.
Danish: Prevymis er effektivt til at forhindre cytomegalovirus i at blive aktiv og forårsage sygdom hos voksne, der har fået udskiftet knoglemarv gennem en stamcelletransplantation.
English: See below.
Danish: Se nedenfor.
English: Date of first authorisation: 18 September 2015
Danish: Dato for første markedsføringstilladelse: 18. september 2015