FrancophonIA/ELRC3.0 huggingface dataset:
English: The adverse reactions identified via post-marketing surveillance are reported voluntarily from a population of uncertain size; it is not always possible to reliably estimate their frequency or establish a causal relationship to palivizumab exposure.
Danish: Bivirkninger, som identificeres ved overvågning efter markedsføring, rapporteres frivilligt fra en population af ukendt størrelse; det er ikke altid muligt at give et pålideligt skøn over hyppigheden eller fastslå en kausal sammenhæng med palivizumab-eksponering.
English: Undesirable effects in clinical studies* and post-marketing reports in paediatric patients MedDRA system organ class
Danish: Bivirkninger i kliniske studier * og rapporter efter markedsføring i pædiatriske patienter
English: Any remaining contents should be discarded after use.
Danish: Overskydende indhold skal bortkastes efter brug.
English: Post-marketing serious spontaneous adverse reactions reported during palivizumab treatment between 1998 and 2002 covering four RSV seasons were evaluated.
Danish: Post-marketing alvorlige spontane bivirkningsrapporter efter behandling med palivizumab som dækker fire RSV-sæsoner mellem 1998 og 2002 er blevet evalueret.
English: It has potent neutralising and fusion-inhibitory activity against both RSV subtype A and B strains.
Danish: Det) har potent neutraliserende og fusionsinhiberende aktivitet mod både RSV undertype A og B stammer.
English: When reconstituted as recommended, the final concentration is 100 mg/ml.
Danish: Når produktet er rekonstitueret som anbefalet, er den endelige koncentration 100 mg/ml.
English: Groups were equally balanced between cyanotic and acyanotic patients.
Danish: Grupperne var jævnt fordelt mellem cyanotiske og ikke-cyanotiske patienter.
English: - The active substance is palivizumab.
Danish: - Det aktive stof er palivizumab.
English: After incubation for 4-5 days, RSV antigen was measured in an enzyme-linked immunosorbent assay (ELISA).
Danish: Efter inkubation i 4-5 dage blev RSV-antigen målt i en ELISA-test (enzym-linked immunosorbent assay).
English: A total of 222 children were enrolled in two separate studies to examine the safety of palivizumab when it is administered for a second RSV season.
Danish: I alt 222 børn deltog i to separate studier til undersøgelse af sikkerheden af palivizumab, når dette gives som behandling i to sæsoner for RSV.
English: This humanised monoclonal antibody is composed of human (95%) and murine (5%) antibody sequences.
Danish: Dette humaniserede monoklonale antistof (er sammensat af human (95%) murin (5%) antistofsekvens.
English: Since the monoclonal antibody is specific for RSV, palivizumab is not expected to interfere with the immune response to vaccines.
Danish: Da det monoklonale antistof er specifikt for RSV, forventes palivizumab ikke at interferere med immunrespons på vacciner.
English: Palivizumab treatment schedule and adverse reactions were monitored in a group of nearly 20,000 infants tracked through a patient compliance registry between 1998 and 2000.
Danish: Skema for palivizumab-behandling og bivirkninger blev monitoreret i en gruppe på næsten 20.000 børn fundet gennem et patient-komplians-register mellem 1998 og 2000.
English: Patients with hemodynamically significant congenital heart disease were excluded from enrollment in this study and were studied in a separate study.
Danish: Patienter med hæmodynamisk signifikant medfødt hjertesygdom blev udelukket fra optagelse i dette studie og blev undersøgt i et separat studie.
English: What Synagis contains
Danish: Synagis indeholder
English: Each injection of Synagis can only help protect your child for about one month before another injection is needed.
Danish: Hver injektion Synagis kan kun beskytte dit barn i cirka en måned, hvorefter en ny injektion er nødvendig.
English: After the water is added, tilt the vial slightly and gently rotate the vial for 30 seconds.
Danish: Når vandet er tilsat hold da hætteglasset lidt skævt og rotér det forsigtigt i 30 sekunder.
English: No difference between groups regarding immunogenicity was observed in either study.
Danish: Der blev ikke observeret forskelle i immunogenicitet i nogen af studierne.
English: There was no association observed between the presence of antibody and adverse events.
Danish: Der blev ikke fundet nogen association mellem tilstedeværelse af antistoffer og bivirkninger.
English: The onset of the adverse reactions occurred after the sixth or greater dose in only 22 of these reports (15 after the sixth dose, 6 after the seventh doses and 1 after the eight dose).
Danish: I kun 22 af disse rapporter forekom bivirkningerne efter den sjette eller flere doser (15 efter den sjette dosis, 6 efter den syvende dosis og 1 efter den ottende dosis).
English: The primary endpoint was a summary of adverse events and serious adverse events, and the secondary endpoint was the incidence of RSV hospitalisation.
Danish: Det primære endepunkt var en sammenfatning af bivirkninger og alvorlige bivirkninger, og det sekundære endepunkt var incidensen af RSV-indlæggelser.
English: This medicinal product should not be mixed with other medicinal products.
Danish: Dette lægemiddel må ikke blandes med andre lægemidler.
English: Subsequent doses should resume monthly through the remainder of the RSV season for children that continue to be at high risk of RSV disease (see section 5.2).
Danish: Efterfølgende doser bør gives månedligt i den resterende del af RSV-sæsonen til børn, som fortsat har høj risiko for RSV-sygdom (se pkt.
English: The marketing authorization holder (MAH) shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing a uthorisation and any agreed subsequent updates of the RMP.
Danish: Indehaveren af markedsføringstilladelsen skal udføre de påkrævede aktiviteter og foranstaltninger vedrørende lægemiddelovervågning, som er beskrevet i den godkendte RMP, der fremgår af modul 1.8.2 i markedsføringstilladelsen, og enhver efterfølgende godkendt opdatering af RMP.
English: Subsequent doses should be administered monthly throughout the RSV season.
Danish: De følgende doser bør gives hver måned igennem hele RSV-sæsonen.
English: Data on fertility, pregnancy and lactation are not available.
Danish: Der findes ingen dokumentation vedrørende fertilitet, graviditet og amning.
English: Your child is at high risk of getting an illness caused by a virus called respiratory syncytial virus (RSV).
Danish: Dit barn har høj risiko for at få en sygdom forårsaget af en den såkaldte respiratoriske syncytialvirus (RSV).
English: Transient, low levels of antipalivizumab antibody were observed in one child after the second dose of palivizumab that dropped to undetectable levels at the fifth and seventh dose.
Danish: Kortvarige lave niveauer af antipalivizumab-antistof blev observeret hos et barn efter den anden dosis af palivizumab, men niveauet faldt til ikke målbart efter den femte og syvende dosis.
English: The powder is a white to off-white cake.
Danish: Pulveret er en hvid til off-white masse.
English: One hundred and three (103) children received monthly palivizumab injections for the first time, and 119 children received palivizumab for two consecutive seasons.
Danish: Eet hundrede og tre (103) børn fik månedlige injektioner af palivizumab for første gang, og 119 børn fik behandling med palivizumab i 2 på hinanden følgende sæsoner.
English: The requirements for submission of PSURs for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Danish: Kravene for fremsendelse af periodiske, opdaterede sikkerhedsindberetninger for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF, og alle efterfølgende opdateringer offentliggjort på det Europæiske Lægemiddelagenturs hjemmeside http://www.emea.europa.eu.
English: In the second study, 211 and 202 premature infants or children with chronic lung disease received liquid and lyophilised palivizumab, respectively.
Danish: I det andet studie, fik 211 og 202 præmature spædbørn eller børn med kronisk lungesygdom henholdvis flydende eller frysetørret palivizumab.
English: Assay interference could lead to false-negative RSV diagnostic test results.
Danish: Interferens med analyser kan føre til falsk-negative diagnostiske testresultater for RSV.
English: Anaphylaxis, anaphylactic shock (in some cases, fatalities have been reported.)
Danish: Anafylaksi, anafylaktisk shock (i nogle tilfælde er der rapporteret dødeligt udfald)
English: To reduce risk of rehospitalisation, it is recommended that children receiving palivizumab who are hospitalised with RSV continue to receive monthly doses of palivizumab for the duration of the RSV season.
Danish: For at nedsætte risikoen for yderligere indlæggelse anbefales det, at børn, som får palivizumab, og som er indlagt med RSV, fortsætter med at få månedlige doser af palivizumab i hele RSV-sæsonens varighed.
English: What should you do if your child misses an injection of Synagis?
Danish: Hvad skal du gøre, hvis dit barn mangler at få en injektion med Synagis?
English: The primary endpoint was the incidence of RSV hospitalisation.
Danish: Det primære endepunkt var incidensen af RSV-indlæggelser.
English: For your child's best protection, it is necessary to take the doctor's advice about when to return for additional doses of Synagis.
Danish: For at dit barn får den bedste beskyttelse, er det nødvendigt at følge lægens råd om, hvornår dit barn skal have yderligere doser Synagis.
English: A total of 1,291 serious reports were received where palivizumab had been administered as indicated and the duration of therapy was within one season.
Danish: Der er sammenlagt modtaget 1291 rapporter, hvor palivizumab er blevet administreret efter indikationen, og behandlingens varighed var en sæson.
English: Injection volumes over 1 ml should be given as a divided dose.
Danish: Injektionsvolumina over 1 ml bør deles i to doser.
English: if your child has any bleeding disorders as Synagis is usually injected into the thigh.
Danish: hvis dit barn har nogen form for blødningsforstyrrelse, da Synagis sædvanligvis sprøjtes ind i låret.
English: Call your doctor or get medical help right away if your child has any of the serious side effects listed above after receiving any dose of Synagis.
Danish: Ring til lægen eller få lægehjælp med det samme, hvis dit barn får nogen af de alvorlige bivirkninger, som er anført ovenfor efter at have fået en dosis Synagis.
English: Single dose toxicology studies have been conducted in cynomolgus monkeys (maximum dose 30 mg/kg), rabbits (maximum dose 50 mg/kg) and rats (maximum dose 840 mg/kg).
Danish: Enkeltdosis toksikologiske forsøg har været gennemført i cynomolgus aber (maksimal dosis 30 mg/kg), kaniner (maksimal dosis 50 mg/kg) og rotter (maksimal dosis 840 mg/kg).
English: Please tell your doctor if your child is unwell, as the use of Synagis may need to be delayed.
Danish: Fortæl lægen, hvis dit barn er sygt, da brugen af Synagis i så fald eventuelt må udsættes.
English: Palivizumab solution should stand at room temperature for a minimum of 20 minutes until the solution clarifies.
Danish: Palivizumabopløsning skal henstå ved stuetemperatur i mindst 20 minutter, indtil opløsningen bliver klar.
English: This was transient, low titre, resolved despite continued use (first and second season), and could not be detected in 55 of 56 infants during the second season (including 2 with titres during the first season).
Danish: Det var forbigående, af lav titer, og forsvandt trods fortsat behandling (første og anden sæson) og kunne ikke spores hos 55 ud af 56 børn i løbet af anden sæson (inklusive 2 med titerværdier i løbet af første sæson).
English: Read all of this leaflet carefully before your child is given this medicine because it contains important information for you and your child.
Danish: Læs denne indlægsseddel grundigt, inden dit barn får dette lægemiddel, da den indeholder vigtige oplysninger.
English: In an observational, post-marketing, database study, a small increase in the frequency of asthma was observed among preterm palivizumab recipients; however, the causal relationship is uncertain.
Danish: I et observations-databasestudie postmarketing blev der set en lille stigning i hyppigheden af astma blandt præmature, som fik palivizumab; årsagssammenhængen er imidlertid usikker.
English: Antibody to palivizumab was observed in approximately 1% of patients in the IMpact-RSV during the first course of therapy.
Danish: Palivizumab-antistof blev observeret hos ca. 1% af patienterne i IMpact-RSV-studiet i løbet af første behandlingsforløb.
English: (3 x 0.15) ml = 0.45 ml palivizumab per month
Danish: (3 x 0,15) ml = 0,45 ml palivizumab pr. måned
English: These adverse reactions are similar in character to those after the initial five doses.
Danish: Disse bivirkninger er sammenlignelige med dem som ses efter de initiale 5 doser.
English: No formal interactions studies with other medicinal products were conducted.
Danish: Der er ikke udført egentlige interaktionsundersøgelser med andre lægemidler.
English: The majority of experience including the pivotal phase III clinical trials with palivizumab has been gained with 5 injections during one season (see section 5.1).
Danish: Størstedelen af erfaringen med palivizumab inklusive de centrale fase III kliniske studier er opnået med 5 injektioner pr. sæson (se pkt.
English: Do not use this medicine after the expiry date which is stated on the label after ‘EXP'.
Danish: Brug ikke dette lægemiddel efter den udløbsdato, der står på pakningen efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Synagis is a medicine to help protect your child from getting severe RSV illness.
Danish: Synagis er et lægemiddel, der kan hjælpe med at beskytte dit barn mod alvorlig RSV-sygdom.
English: RSV hospitalisations occurred among 62 of 3306 (1.9%) patients in the palivizumab group.
Danish: RSV-indlæggelser forekom hos 62 ud af 3306 (1,9%) patienter i palivizumab-gruppen.
English: To ensure the correct volume is reconstituted for Synagis, see section 6.6.
Danish: For at sikre at det korrekte volume af Synagis bliver rekonstitueret se pkt.
English: Immunogenicity was not studied in the congenital heart disease study.
Danish: Immunogenicitet blev ikke undersøgt i studiet med børn med medfødt hjertesygdom.
English: Solvent for Synagis
Danish: Solvens til Synagis
English: PC SN NN
Danish: PC: SN:
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTALDOSER
English: The incidence of RSV hospitalisation was 16 of 612 (2.6%) in the palivizumab group.
Danish: Incidensen af RSV-indlæggelser var 16 ud af 612 (2,6%) i palivizumab-gruppen.
English: Palivizumab exhibited median EC50 values of 0.65 g/ml (mean [standard deviation] = 0.75 [0.53] g/ml; n=69, range 0.07-2.89 g/ml) and 0.28 g/ml (mean [standard deviation] = 0.35 [0.23] g/ml; n=35, range 0.03-0.88 g/ml) against clinical RSV A and RSV B isolates, respectively.
Danish: Palivizumab viste mediane EC50-værdier på henholdsvis 0,65 g/ml (middelværdi [standardafvigelse] = 0,75 [0,53] g/ml; n=69; interval 0,07-2,89 g/ml) og 0,28 g/ml (middelværdi [standardafvigelse] = 0,35 [0,23] g/ml; n=35; interval 0,03-0,88 g/ml) mod kliniske RSV-A- og RSV-B-isolater.
English: No polymorphic or non-polymorphic sequence variations outside of the A antigenic site on the RSV F protein were shown to render RSV resistant to neutralisation by palivizumab.
Danish: Ingen polymorfe eller non-polymorfe sekvensvariationer udenfor antigen-site A på RSV-F-protein har vist at kunne gøre RSV resistent mod neutralisering af palivizumab.
English: Palivizumab should be given with caution to patients with thrombocytopaenia or any coagulation disorder.
Danish: Palivizumab bør gives med forsigtighed til patienter med trombocytopeni eller anden form for koagulationsforstyrrelse.
English: In addition, palivizumab inhibits virus replication in cell culture and, therefore, may also interfere with viral culture assays.
Danish: Derudover hæmmer palivizumab virusreplikation i cellekulturer og kan derfor også påvirke analyser i viral kultur.
English: The possible risk of enhanced RSV infection in the season following the season in which the patients were treated with palivizumab has not been conclusively ruled out by studies performed aiming at this particular point.
Danish: Den mulige risiko for forværring af RSV-infektion i sæsonen efter den sæson hvori patienterne blev behandlet med palivizumab er ikke blevet modbevist af studier, der havde til formål at vise dette.
English: CHD Study 2: this trial, conducted at 162 centers in North America, European Union and 4 other countries over two RSV seasons, studied patients less than or equal to 24 months of age with hemodynamically significant CHD.
Danish: CHD-studie 2: i dette studie, som blev gennemført på 162 centre i Nordamerika, den Europæiske Union og 4 andre lande i to RSV-sæsoner, blev patienter på 24 måneder eller yngre med hæmodynamisk signifikant CHD inkludret.
English: Palivizumab serum concentrations of approximately 30 g/ml have been shown to produce a 99% reduction in pulmonary RSV replication in the cotton rat model.
Danish: Palivizumab-serumkoncentrationer på cirka 30 g/ml er vist at medføre en 99% reduktion i pulmonal RSV-replikation i cotton-rat-modellen.
English: 1ml of water for injections in an ampoule (type I glass).
Danish: 1 ml vand til injektionsvæsker i en ampul (type I glas).
English: Synagis should be given to your child at a dose of 15 mg/kg body weight once a month for as long as the risk of RSV infection remains.
Danish: Dit barn vil få Synagis en gang om måneden i en dosis på 15 mg/kg legemsvægt, så længe risikoen for RSV-infektion er til stede.
English: • Children less than 2 years of age and with haemodynamically significant congenital heart disease.
Danish: • Børn under 2 år,som har hæmodynamisk signifikant medfødt hjertesygdom.
English: Palivizumab solution for injection does not contain a preservative, is for single use and should be administered immediately after drawing the dose into the syringe.
Danish: Palivizumab injektionsvæske, opløsning indeholder ikke konserveringsmiddel og er til engangsbrug og skal administreres straks efter, at dosis er trukket op i sprøjten.
English: The antiviral activity of palivizumab was assessed in a microneutralization assay in which increasing concentrations of antibody were incubated with RSV prior to addition of the human epithelial cells HEp-2.
Danish: Palivizumabs antivirale aktivitet er undersøgt i en mikroneutraliseringstest, hvor stigende koncentrationer af antistof blev inkuberet med RSV inden tilsætning af de humane epitel-celler HEp2.
English: The RSV hospitalisation rate was 10.6% in the placebo group.
Danish: RSV-indlæggelsesgraden var 10,6% i placebogruppen.
English: The gluteal muscle should not be used routinely as an injection site because of the risk of damage to the sciatic nerve.
Danish: Glutealmuskulaturen bør ikke benyttes rutinemæssigt som injektionssted på grund af risiko for skade på iskiasnerven.
English: From the post-marketing experience, overdoses with doses up to 85 mg/kg have been reported and in some cases, adverse reactions were reported which did not differ from those observed with 15 mg/kg dose (see section 4.8).
Danish: Efter markedsføring er der rapporteret om tilfælde af overdosering med doser på op til 85 mg/kg, hvor de rapporterde bivirkninger ikke adskilte sig fra de bivirkninger, som ses ved en dosis på 15 mg/kg (se pkt.
English: Ninety-seven percent of all subjects receiving palivizumab completed the study and 95% received all five injections.
Danish: 97 % af alle forsøgspatienter, som fik palivizumab, gennemførte studiet, og 95% fik alle fire injektioner.
English: Adverse reactions observed in patients after a sixth or greater dose were similar in character and frequency to those after the initial 5 doses.
Danish: De bivirkninger, som forekom hos patienterne efter den sjette eller flere doser, var sammenlignelige i karakter og frekvens med dem som forekom efter de første 5 doser.
English: The most serious adverse reactions occurring with palivizumab are anaphylaxis and other acute hypersensitivity reactions.
Danish: De alvorligste bivirkninger som ses ved behandling med palivizumab anafylaktiske og andre akutte hypersensitivitetsreaktioner.
English: The results of this trial indicated that the trough serum concentrations of palivizumab were similar between the liquid formulation and the lyophilised formulation and bioequivalence of the liquid and the lyophilised formulation was demonstrated.
Danish: Resultaterne fra dette studie viste, at de laveste serumkoncentrationer af palivizumab var sammenlignelige mellem den flydende og den frysetørrede formulering, og der blev vist bioækvivalens mellem flydende og den frysetørrede formulering.
English: The RSV hospitalisation rate observed in patients enrolled with a diagnosis of CLDP was 28/723 (3.9%) and in patients enrolled with a diagnosis of prematurity without CLDP was 34/2583 (1.3%).
Danish: RSV-indlæggelsesraten hos patienter inkluderet med diagnosen CLDP var 28/723 (3,9%), og 34/2583 (1,3%) hos patienter inkluderet med diagnosen præmatur uden CLDP.
English: Synagis Water for injections ampoule label
Danish: Synagis Vand til injektionsvæsker, ampul etiket
English: The RSV hospitalisation rate was 9.7% in the placebo group and 5.3% in the Synagis group.
Danish: Antallet af indlæggelser på grund af RSV var 9,7% i placebogruppen og 5,3% i Synagis-gruppen.
English: 1 ml Water for injections
Danish: 1 ml vand til injektionsvæsker
English: No deaths were considered related to palivizumab and no new ADRs were identified in these studies.
Danish: I disse studier blev ingen dødsfald betragtet som relateret til palivizumab, og ingen nye bivirkninger blev identificeret.
English: Allergic reactions including very rare cases of anaphylaxis and anaphylactic shock have been reported following palivizumab administration.
Danish: Allergiske reaktioner inklusive meget sjældne tilfælde af anafylaktiske reaktioner og anafylaktisk shock er blevet rapporteret efter administration af palivizumab.
English: Synagis will be given by injection to your child into a muscle, usually in the outer part of the thigh.
Danish: Dit barn vil få Synagis sominjektion i en muskel, sædvanligvis på ydersiden af låret.
English: Analysis of 254 clinical RSV isolates collected from immunoprophylaxis-naïve subjects revealed palivizumab resistance-associated substitutions in 2 (1 with N262D and 1 with S275F), resulting in a resistance associated mutation frequency of 0.79%.
Danish: Analyse af 254 kliniske RSV-isolater indsamlet fra immunprofylakse-naive forsøgspersoner viste palivizumab-resistens-associerede substitutioner hos 2 (1 med N262D og 1 med S275F), hvilket giver i en resistens-associeret mutationsfrekvens på 0,79%.
English: Palivizumab solution does not contain a preservative and should be administered within 3 hours of preparation.
Danish: Palivizumabopløsning indeholder ikke konserveringsmiddel og skal indgives inden for 3 timer efter tilberedningen.
English: The overall rate and pattern of adverse events, study drug discontinuation due to AEs, and the number of deaths reported in these clinical studies were consistent with those observed during the clinical development programs for the lyophilised formulation.
Danish: I disse kliniske studier var den samlede forekomst og mønsteret af bivirkninger, seponering af studie-medicin på grund af bivirkninger, og antallet af rapporterede dødsfald i overenstemmelse med dem, som blev observeret, under det kliniske udviklingsprogram for den frysetørrede formulering.
English: Ninetyeight percent of all subjects receiving palivizumab completed the study and 97% received all five injections.
Danish: 98 % af alle forsøgspatienter, som fik palivizumab, gennemførte studiet, og 97% fik alle 5 injektioner.