natgillin/translations-raw huggingface dataset:
Desuden sås der en tendens til bedre virkning ved behandling med pentosanpolysulfatnatrium i patienternes egenvurdering af forbedring i smerter og vandladningstrang, selvom der blev observeret en afvigelse i vurderingen af vandladningstrang ved brug af skalaen. 
Furthermore a trend for better efficacy of pentosane polysulfate sodium was observed for the patients self-assessment of an improvement of pain and urgency, despite a deviating effect observed for the evaluation of urgency via the scale.
Ikke almindelig Øget tåreflåd, amblyopi 
Uncommon Lacrimation, amblyopia
Virkning og anvendelse elmiron er et lægemiddel, der indeholder det aktive stof pentosanpolysulfatnatrium. 
What elmiron is and what it is used for elmiron is a medicine that contains the active substance pentosan polysulfate sodium.
Der foreligger ingen oplysninger om en eventuel indvirkning af pentosanpolysulfatnatrium på fertilitet. 
No information on a potential impact of pentosane polysulfate sodium on fertility is available.
Derudover blev virkningen på smerter og imperiøs vandladning vurderet ved hjælp af en 5-punkts-skala, hvor en responder blev defineret som en patient, der oplevede en forbedring på minimum 1 point i forhold til baseline. 
In addition the impact on pain and urgency was evaluated via a 5 score scale, where a responder was defined as a patient experiencing at least a 1-point improvement compared to baseline.
Indehaver af markedsføringstilladelsen og fremstiller bene-Arzneimittel GmbH Herterichstrasse 1-3 
Marketing Authorisation Holder and Manufacturer bene-Arzneimittel GmbH Herterichstrasse 1-3
Ikke almindelig Anoreksi, vægtstigning, vægttab 
Uncommon Anorexia, weight gain, weight loss
I alle studierne rapporterede patienterne en større subjektiv forbedring af smertefuldt blæresyndrom ved behandling med pentosanpolysulfatnatrium sammenholdt med placebo. 
In all of these studies, patients reported a better subjective improvement of bladder pain syndrome under treatment with pentosan polysulfate sodium compared to placebo.
Graviditet og amning elmiron anbefales ikke under graviditet eller amning. 
Pregnancy and breast-feeding elmiron is not recommended during pregnancy or breast-feeding.
Trafik- og arbejdssikkerhed elmiron påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner. 
Driving and using machines elmiron has no or negligible influence on the ability to drive and use machines.
En patient blev anset som responder på behandlingen, hvis han/hun efter tre måneders behandling oplevede en forbedring af et specifikt symptom på 50 % i forhold til baseline. 
A patient was counted as a responder to treatment in case a 50% improvement compared to baseline was reported for a specific symptom after 3 months of treatment.
En samlet analyse af de ovenfor beskrevne data fra placebokontrollerede kliniske studier blev gennemført for at vurdere, om patienter, der tager oralt pentosanpolysulfatnatrium, har en klar fordel ved behandlingen. 
A pooled analysis of the data described above from placebo-controlled clinical studies was conducted to evaluate, whether patients taking oral pentosane polysulfate sodium have clear benefit from the treatment.
Virkningen på smerter og imperiøs vandladning blev evalueret ved hjælp af det samme spørgeskema som det primære endepunkt, og en responder blev defineret som en patient, der oplevede en som minimum moderat forbedring (50 %) i forhold til baseline. 
The impact on pain and urgency was evaluated via the same questionnaire as the primary endpoint with a responder defined as a patient experiencing an at least moderate (50%) improvement compared to baseline.
Pentosanpolysulfatnatrium påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner. 
Pentosan polysulfate sodium has no or negligible influence on the ability to drive and use machines.
Lever- eller nyreinsufficiens elmiron er ikke undersøgt hos patienter med lever- eller nyreinsufficiens. 
Hepatic or renal insufficiency elmiron has not been studied in patients with hepatic or renal insufficiency.
I det andet af de to meget ens studier deltog 148 patienter, og der blev påvist en statistisk signifikant fordel ved pentosanpolysulfatnatrium over for placebo i forhold til den samlede patientvurderede forbedring af smerte og vandladningstrang, som var det primære endepunkt, og den samlede investigatorvurderede forbedring. 
The second of the two very comparable studies enrolled 148 patients and demonstrated a statistically significant benefit pentosan polysulfate sodium over placebo was demonstrated on the patient reported overall improvement evaluated as primary endpoint and an the investigator-assessed overall improvement, all evaluations on pain and urgency.
Anvendes inden 45 dage efter anbrud. 
After first opening: use within 45 days.
Stigning ≥ 20 ml (% af patienterne) Samlet daglig urinmængde (ml) 
Increase of ≥ 20 cc (% pts) Total daily urine volume (cc)
Amning Det er ukendt, om pentosanpolysulfatnatrium/metabolitter udskilles i human mælk. 
It is unknown whether pentosane polysulfate sodium or metabolites are excreted in human milk.
Den samlede analyse viste, at procentdelen af patienter, der responderede på behandlingen med pentosanpolysulfatnatrium med en klinisk relevant forbedring i deres samlede vurdering af smerter og vandladningstrang, var ca. 2 gange højere end de tilsvarende responderfrekvenser ved placebo. 
This pooled analysis showed that the percentage of patients responding to treatment with pentosan polysulfate sodium with a clinically relevant improvement in their overall assessment, pain and urgency was approximately 2-fold higher than the respective responder rates under placebo:
• øget svedtendens, søvnløshed 
• increased sweating, sleeplessness
Antal vandladninger pr. dag ns 
Voids per day ns
Patienter, der skal gennemgå en invasiv procedure, eller som har symptomer på underliggende koagulopati eller anden øget risiko for blødning (behandling med andre lægemidler, der indvirker på koagulationen, f.eks. antikoagulantia, heparinderivater, trombolytiske eller trombocytfunktionshæmmende lægemidler, herunder acetylsalicylsyre og andre nonsteroide antiinflammatoriske lægemidler (se pkt. 
Patients undergoing invasive procedures or having signs/symptoms of underlying coagulopathy or other increased risk of bleeding (due to treatment with other medicinal products influencing coagulation such as anticoagulants, heparin derivatives, thrombolytic or antiplatelet agents including acetylsalicylic acid, or nonsteroidal antiinflammatory medicinal products (see section 4.5)) should be evaluated for haemorrhagic events.
EU/1/17/1189/001 EU/1/17/1189/002 EU/1/17/1189/003 
EU/1/17/1189/001 EU/1/17/1189/002
Brug af anden medicin sammen med elmiron 
Other medicines and elmiron
Patienterne blev randomiseret til fire behandlingsgrupper og fik 3 x 100 mg pentosanpolysulfatnatrium, 1 x 50 mg hydroxyzin, begge aktive stoffer eller placebo i seks måneder. 
Patients were randomized to four treatment group and were treated for six months with 3x100 mg pentosane polysulfate sodium, 1x50 mg hydroxyzine, both active treatments or placebo.
Gennemsnitligt IC-symptom-indeks ± SD (0-20) -2,6 ± 3,4 Gennemsnitligt IC-problem-indeks ± SD (0-16) Gennemsnitlig Wisconsin IC-score ± SD (0-42) 
No. complete secondary end point data (%) Mean pain score ± SD (0-9) Mean urgency score ± SD (0-9) Mean 24-hr frequency ± SD Mean IC symptom index ± SD (0-20) Mean IC problem index ± SD (0-16) Mean Wisconsin IC score ± SD (0-42)
Stigning ≥ 20 ml (% af patienterne) 
Increase of ≥ 20 cc (% pts)
En vurdering af alle data fra studiet viste, at der for alle fire symptomer var statistisk signifikant flere patienter, som responderede på pentosanpolysulfatnatrium end på placebo. 
An evaluation of all data generated in the study showed that for all four symptoms statistically significant more patients responded to pentosan polysulfate sodium treatment compared to placebo:
EXP Anvendes inden 45 dage efter anbrud. 
EXP After first opening: use within 45 days.
Det første studie var et dobbeltblindt, randomiseret, placebokontrolleret studie med en planlagt overkrydsning til undersøgelse af pentosanpolysulfatnatrium over for placebo. 
The first study was a double-blind, randomized, placebo-controlled study with a planned cross-over design evaluating pentosan polysulfate sodium versus placebo.
Pentosanpolysulfatnatrium bør derfor ikke anvendes under amning. 
Therefore, pentosan polysulfate sodium should not be used during breast-feeding.
Respondere baseret på patienternes egenvurdering af samlet forbedring Respondere baseret på investigatorernes vurdering af samlet forbedring Respondere mht. smerter og vandladningstrang Smerter (moderat/op til 50 % forbedring) Smerteskala (1 points forbedring) Vandladningstrang (moderat/op til 50 % forbedring) Vandladningstrang (1 points forbedring) 
Responders based on patients self-evaluation of overall improvement Responders based on investigators evaluation of overall improvement Responders regarding pain and urgency Pain (moderate/50% improvement) Pain scale (1-point improvement) Pressure to urinate (moderate/50% improvement) Urgency scale (1-point improvement)
De bivirkninger, der blev rapporteret under behandling med pentosanpolysulfatnatrium, svarede til de bivirkninger, der blev rapporteret for placebo, hvad angår både art og antal. 
The adverse events reported under treatment with pentosan polysulfate sodium were comparable to those reported under treatment with placebo in regards to quality and quantity.
Respondere baseret på patienternes egenvurdering af samlet forbedring Respondere baseret på investigatorernes vurdering af samlet forbedring Respondere mht. smerter og vandladningstrang Smerter (moderat/op til 50 % forbedring) Smerteskala (1 points forbedring) Vandladningstrang (moderat/op til 50 % forbedring) Respondere mht. smerter og vandladningstrang Forbedring af samleje Ændringer fra baseline i tømningsvolumen Middelvolumen pr. vandladning (ml) 
Responders based on patients self-evaluation of overall improvement Responders based on investigators evaluation of overall improvement Responders regarding pain and urgency Pain (moderate/50% improvement) Pain scale (1-point improvement) Pressure to urinate (moderate/50% improvement) Responders regarding pain and urgency Improved sexual intercourse Changes from baseline voided volume Mean volume per void (cc)
Hver pakning indeholder 300°(3°beholdere°x°100) kapsler. 
Each carton contains 300 (3 bottles x 100) capsules.
• vejrtrækningsbesvær 
• breathing difficulties
En responder blev defineret som en patient med en som minimum god forbedring i forhold til baseline. 
A responder was defined as a patient assessed to be at least “good” compared to baseline.
På grund af pentosanpolysulfatnatriums svagt antikoagulerende virkning bør patienter, der samtidig er i behandling med antikoagulantia, heparinderivater, trombolytiske eller trombocytfunktionshæmmende lægemidler, herunder acetylsalicylsyre og andre nonsteroide antiinflammatoriske lægemidler, evalueres for blødningshændelser for om nødvendigt at justere dosis (se pkt. 
Due to the weak anticoagulant effect of pentosan polpysulfate sodium, patients, who are concomitantly treated with anticoagulants, heparin derivatives, thrombolytic or antiplatelet agents including acetylsalicylic acid, or nonsteroidal anti-inflammatory medicinal products should be evaluated for any haemorrhagic event in order to adapt the dose if needed (see section 4.4).
Øget svedtendens, søvnløshed, hyperkinesi, paræstesi 
Increased sweating, insomnia, hyperkinesia, paraesthesia
Efter oral administration udskilles ikke-absorberet pentosanpolysulfatnatrium hovedsageligt uomdannet i fæces. 
After oral administration unabsorbed pentosan polysulfate sodium is excreted predominantly unchanged in the faeces.
Pakningsstørrelse: 90 kapsler. 
Pack size of 90 capsules.
Gennemsnitlig procentvis forbedring* (*Gennemsnitlig ± SD) 
Av. improvement* (*Mean ± SD)
• appetitløshed, vægtstigning eller vægttab 
• loss of appetite, weight gain or loss
Sekundære resultatmål omfattede O'Leary-Sant IC Symptom and Problem Index, University of Wisconsin Symptom score, 
Secondary outcome measures included the O'Leary-Sant IC Symptom and Problem Index, the University of Wisconsin Symptom score, patient reported symptoms of pain/discomfort and urgency, and results of a 24-hour voiding diary.
Afhængigt af hvilken klinik patienterne blev behandlet på, fik de enten 3 x 100 mg eller 2 x 200 mg pentosanpolysulfatnatrium pr. dag. 
Depending on which institution the patients attended they were treated with either 3x100 mg or 2x200 mg PPS per day.
Da der er evidens for, at nyrerne og leveren medvirker til elimination af pentosanpolysulfatnatrium, kan lever- eller nyreinsufficiens have en indvirkning på pentosanpolysulfatnatriums farmakokinetik. 
Because there is evidence of hepatic and renal contribution to the elimination of pentosan polysulfate sodium, hepatic or renal impairment may have an impact on the pharmacokinetics of pentosan polysulfate sodium.
300 (3°x°100) kapsler, hårde 
300 (3x100) hard capsules
Det skal du vide, før du begynder at tage elmiron Tag ikke elmiron: 
What you need to know before you take elmiron Do not take elmiron if you are
• Aktivt stof: pentosanpolysulfatnatrium. 
• The active substance is pentosan polysulfate sodium.
Patienter med relevant lever- eller nyreinsufficiens bør overvåges nøje under behandling med pentosanpolysulfatnatrium. 
Patients with relevant hepatic or renal insufficiency should be carefully monitored when treated with pentosan polysulfate sodium.
Hvis du oplever bivirkninger, skal du holde op med at tage elmiron, indtil de er forsvundet igen. 
Stop taking elmiron if side effects occur, until they disappear.
Indlægsseddel: Information til patienten elmiron 100 mg hårde kapsler pentosanpolysulfatnatrium 
Package leaflet: Information for the patient elmiron 100 mg hard capsules pentosan polysulfate sodium
Anæmi, ekkymose, blødning, leukopeni, trombocytopeni 
Anaemia, ecchymosis, haemorrhage, leukopenia, thrombocytopenia
Patienter, der tidligere har haft heparin- eller pentosanpolysulfatnatriuminduceret trombocytopeni, bør overvåges nøje under behandlingen med pentosanpolysulfatnatrium. 
Patients who have a history of heparin or pentosan polysulfate sodium induced thrombocytopenia should be carefully monitored when treated with pentosan polysulfate sodium.
• led- eller muskelsmerter 
• joint or muscle pain
Der er i litteraturen beskrevet i alt fire randomiserede, placebokontrollerede, dobbeltblinde kliniske studier, der prospektivt inkluderede patienter med smertefuldt blæresyndrom diagnosticeret ved cystoskopi med eller uden blære-hydrodistension, og som undersøgte virkningen af behandling med oralt pentosanpolysulfatnatrium. 
A total of four randomised placebo-controlled, double-blind clinical studies prospectively enrolling patients with bladder pain syndrome diagnosed via cystoscopic examination with or without bladder hydrodistension evaluating the efficacy of oral treatment with pentosan polysulfate sodium were published in scientific literature.
I nedenstående afsnit anføres de bivirkninger, der er beskrevet i litteraturen efter kliniske studier med pentosanpolysulfatnatrium. 
The following section lists adverse events reported in the literature from clinical studies with pentosan polysulfate sodium.
Hos de patienter, der responderer på behandlingen, bør behandlingen fortsættes kronisk, så længe responsen fastholdes. 
In responders pentosan polysulfate sodium treatment should be continued chronically as long as the response is maintained.
Behandlingen bør genoptages ved den anbefalede dosis efter en kritisk vurdering af risici. 
In case of adverse reactions, treatment might be paused until the symptoms abate and treatment should be continued at the recommended dose after a critical balancing of the risks thereafter.
Mens pentosanpolysulfatnatrium hurtigt fjernes fra cirkulationen efter intravenøs indgift, er den tilsyneladende plasma-halveringstid efter oral administration 24-34 timer. 
administration, the apparent plasma half-life after oral administration is in the range of 24-34 hours.
HDPE-beholder med et forseglet og børnesikret PP-låg med 100 kapsler. 
HDPE bottle with a tamper-evident child resistant closure of PP with 100 capsules.
Kvalme, diarré, dyspepsi, abdominalsmerter, udspilet abdomen, rektalblødning 
Nausea, diarrhoea, dyspepsia, abdominal pain, abdomen enlarged, rectal haemorrhage
Virkningen af behandlingen blev vurderet på grundlag af patientrapporteret forbedring af fire typiske symptomer på smertefuldt blæresyndrom: smerte, imperiøs vandladning, øget vandladningshyppighed og nykturi. 
Efficacy of treatment was evaluated based on the patient reported improvement on four typical symptoms of bladder pain syndrome: pain, urgency, frequency, and nocturia, no primary endpoint was defined.
Perifert ødem, alopeci Ikke almindelig Udslæt, voksende modermærker 
Peripheral oedema, alopecia Uncommon Rash, increased mole size
Hos raske frivillige forsøgspersoner resulterede en enkelt parenteral administration af radioaktivt mærket pentosanpolysulfatnatrium i en progressiv optagelse af al radioaktivitet i lever, milt og nyrer (50 min. efter 1 mg/kg intravenøst: 60 % af dosen i leveren, 7,7 % i milten; 3 timer efter administration: 60 % i leveren + milten og 13 % i blæren). 
In healthy volunteers, a single parenteral administration of radioactively labelled pentosan polysulfate sodium leads to a progressive up-take of total radioactivity by the liver, spleen, and kidney (50 min after 1 mg/kg i.v.
Der sås en tendens til bedre virkning ved pentosanpolysulfatnatrium, hvad angår forbedring af samleje. 
A trend for better efficacy under pentosan polysulfate sodium was observed for improved sexual intercourse:
HDPE-beholder med et forseglet og børnesikret PP-låg med 90 kapsler. 
HDPE bottle with a tamper-evident child resistant closure of PP with 90 capsules.
I begge studier fik patienterne enten 3 x 100 mg pentosanpolysulfatnatrium eller placebo i tre måneder. 
The patients in both studies were treated for three months with either 3x100 mg pentosan polysulfate sodium or placebo.
Antal respondere/totalt (%) Gennemsnitlig procentvis forbedring* 
No. responders / total (%) Av. % improvement* Urgency
MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE ÆSKE TIL BLISTRE 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR BLISTERS
90 kapsler, hårde 3°beholdere 
90 hard capsules 3 bottles
Immunsystemet 
Immune system disorder
Sådan skal du tage elmiron 
How to take elmiron
FARMAKOLOGISKE EGENSKABER 5.1. 
PHARMACOLOGICAL PROPERTIES 5.1 Pharmacodynamic properties
FARMACEUTISKE OPLYSNINGER 6.1. 
PHARMACEUTICAL PARTICULARS 6.1 List of excipients
elmiron 100 mg, hårde kapsler pentosanpolysulfatnatrium 
elmiron 100 mg hard capsules pentosan polysulfate sodium
• hvis du har nedsat lever- eller nyrefunktion. 
• reduced liver or kidney function
90 kapsler, hårde 100 kapsler, hårde 
90 hard capsules 100 hard capsules
Pakningsstørrelse: 300°(3°beholdere°x°100) kapsler. 
Pack size of 300 (3 bottles x 100) capsules.
Terapeutiske indikationer elmiron er indiceret til behandling af smertefuldt blæresyndrom hos voksne, karakteriseret ved enten glomerulationer eller Hunners læsioner, moderate til svære smerter, imperiøs vandladning og øget vandladningshyppighed (se pkt. 
CLINICAL PARTICULARS 4.1 Therapeutic indications elmiron is indicated for the treatment of bladder pain syndrome characterized by either glomerulations or Hunner's lesions in adults with moderate to severe pain, urgency and frequency of micturition (see section 4.4).
Unormale leverfunktionstest 
• abnormal liver function
90 kapsler, hårde 
90 hard capsules
Det antages, at der ud over pentosanpolysulfatnatriums antiinflammatoriske aktivitet kan være tale om en potentiel barrierefunktion i forhold til den beskadigede uroteliale slimhinde. 
It is hypothesized, that a potential barrier function of pentosan polysulfate sodium instead of the damaged urothelial mucus might play a role as well the antiinflammatory activity of pentosan polysulfate sodium.
MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE ÆSKE TIL BEHOLDER 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR BOTTLE
Antal randomiserede patienter Antal respondere (%) 
No. responders (%)
• hvis du skal opereres 
• to undergo surgery
• unormal prikkende eller stikkende fornemmelse i huden og kløe 
• abnormal sensation such as prickling, tingling and itchiness
• kvalme, fordøjelsesbesvær, diarré, mavesmerter, udspilet mave 
• nausea, indigestion, diarrhoea, abdominal pain, abdomen enlarged
Opbevaringsforhold efter anbrud af lægemidlet, se pkt. 
For storage conditions after first opening of the bottle, see section 6.3.
• blødning fra endetarmen 
• blood clotting disorders
Hver kapsel indeholder 100 mg pentosanpolysulfatnatrium. 
Each capsule contains 100 mg of pentosan polysulfate sodium.
• tåreflåd, synsnedsættelse (dovne øjne − amblyopi) 
• weakness, pelvic (lower abdomen) pain
D-81479 München Tlf.: +49 (0) 89 / 7 49 87-0 
D-81479 Munich tel: ++49 (0) 89 / 7 49 87-0 fax: ++49 (0) 89 / 7 49 87-142 e-mail: contact@bene-arzneimittel.de
• hududslæt, voksende modermærker 
• skin rash, increased mole size
En hård kapsel indeholder 100 mg pentosanpolysulfatnatrium. 
One hard capsule contains 100 mg pentosan polysulfate sodium.
Hvis du har taget for meget elmiron 
If you take more elmiron than you should
Hver hård kapsel indeholder 100 mg pentosanpolysulfatnatrium. 
Each hard capsule contains 100 mg of pentosan polysulfate sodium.
• hovedpine, rygsmerter 
• headache, back pain
C. ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN D. BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL SIKKER OG 
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
D-81479 München Tlf.: +49 (0)89 749870 
D-81479 Munich tel: +49 (0)89 749870 fax: +49 (0)89 74987142 e-mail: contact@bene-arzneimittel.de
Nykturi 
Posology
Ændringer fra baseline i vandladningskarakteristika 
Changes from baseline voiding characteristics Mean volume per void (cc)
Nyrer og urinveje 
No. randomized
Vandladningshyppighed Antal respondere/totalt (%) Gennemsnitlig procentvis forbedring 
No. responders / total (%) Av. % improvement* Frequency
• mundsår 
• mouth ulcer
Regler for bortskaffelse 
6.6 Special precautions for disposal
• fordøjelsesbesvær, opkastning, luft i maven, afføringsbesvær 
• indigestion, vomiting, wind, difficultiy passing stools
Navn og adresse på den fremstiller, der er ansvarlig for batchfrigivelse bene-Arzneimittel GmbH Herterichstrasse 1 - 3 81479 München Tyskland 
Name and address of the manufacturer responsible for batch release bene-Arzneimittel GmbH Herterichstr.
Der er ikke udført studier af reproduktions- og udviklingstoksicitet. 
The effect of pentosan polysulfate sodium on reproductive and developmental toxicity has not been investigated.
Fordøjelsesbesvær, opkastning, mundsår, luft i maven, forstoppelse 
Indigestion, vomiting, mouth ulcer, flatulence, constipation
Øget vandladningshyppighed 
Urinary frequency
Dette gælder både mænd og kvinder. 
This applies to both men and women.
Længere overvågningsperioder kan være påkrævet. 
Longer periods of monitoring may be required.
Efter 18 måneder 
After 18 months
(angivet i punkt 6). 
(listed in section 6).
Der blev ikke rapporteret om dødsfald i studiet. 
There were no deaths reported in the study.
Antal hændelser/patient/år 
Number of events / patient/ year
Biotilgængeligheden er komplet eller næsten komplet hos kræftpatienter. 
Bioavailability is complete or nearly complete in cancer patients.
Resultaterne af dette studie er vist i tabel 2 og 3 nedenfor. 
Results of this study are presented in Tables 2 and 3 below.
Disse forstyrrelser er også forbundet med den underliggende sygdom. 
These disorders are also associated with the underlying disease.
MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/19/1366/001 
MARKETING AUTHORISATION NUMBER(S) EU/1/19/1366/001
Desuden understøttes fundene fra disse pivotale studier af observationsstudier, hvoraf nogle omfattede langvarig opfølgning. 
Furthermore, findings from these pivotal studies are supported by observational studies including some long-term follow up.
Parvovirus B19-infektion 
Parvovirus B19 infection