FrancophonIA/ELRC3.0 huggingface dataset:
English: For symptomatic diabetes, nivolumab should be withheld, and insulin replacement should be initiated as needed.
Danish: Ved symptomatisk diabetes bør nivolumabdosering udsættes og insulinbehandling initieres efter behov.
English: Hepatic impairment
Danish: Hududslæt, kløe
English: For symptomatic hypothyroidism, nivolumab should be withheld, and thyroid hormone replacement should be initiated as needed.
Danish: Ved symptomatisk hypotyroidisme bør nivolumabdosering udsættes, og substitutionsbehandling med thyroideahormon initieres efter behov.
English: Three patients, including 2 patients with a Grade 3 case, received high-dose corticosteroids (at least 40 mg prednisone equivalents) at a median initial dose of 0.6 mg/kg (range: 0.4-1.3) for a median duration of 2.0 weeks (range: 1.4-14.1).
Danish: Tre patienter, herunder 2 patienter med grad 3 tilfælde, fik højdosis kortikosteroid (i en dosis mindst ækvivalent med 40 mg prednison) med en median initialdosis på 0,6 mg/kg (0,4-1,3) i en medianperiode på 2,0 uger (1,4-14,1).
English: Common diarrhoea, stomatitis, vomiting, abdominal pain, constipation, dry mouth
Danish: Ikke almindelig anafylaktisk reaktion, overfølsomhed, infusionsrelateret reaktion Det endokrine system diarre, stomatitis, opkastning, abdominalsmerter, obstipation, mundtørhed
English: Underactive thyroid gland which can cause tiredness or weight gain Inflammation of the nerves causing numbness, weakness, tingling or burning pain of the arms and legs, headache, dizziness
Danish: Almindelig (kan forekomme hos op til 1 ud af 10 personer) Nedsat funktion af skjoldbruskkirtlen, hvilket kan medføre træthed eller vægtstigning Betændelseslignende tilstand (inflammation) i nerverne, som medfører følelsesløshed, svaghed, snurren eller brændende smerter i arme og ben, hovedpine, svimmelhed Betændelse i lungerne (pneumonitis) med hoste og vejrtrækningsbesvær; åndenød (dyspnø), hoste
English: Do not store any unused portion of the infusion solution for reuse.
Danish: Eventuelle rester af infusionsvæsken må ikke gemmes til senere brug.
English: For Grade 3 or 4 pneumonitis, nivolumab must be permanently discontinued, and corticosteroids should be initiated at a dose of 2 to 4 mg/kg/day methylprednisolone equivalents.
Danish: Ved grad 3 eller 4 pneumonitis skal nivolumab seponeres permanent, og kortikosteroid bør initieres med en dosis ækvivalent med 2-4 mg/kg/dag methylprednisolon.
English: If applicable, dilute with the required volume of sodium chloride 9 mg/mL (0.9%) solution for injection or 50 mg/mL (5%) glucose solution for injection.
Danish: Hvis det er relevant, udføres fortynding med det påkrævede volumen natriumchlorid 9 mg/ml (0,9%) injektionsvæske eller glucose 50 mg/ml (5%) injektionsvæske.
English: MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Danish: FREMSTILLER AF DET BIOLOGISK AKTIVE STOF OG FREMSTILLER
English: If worsening or no improvement occurs despite initiation of corticosteroids, corticosteroid dose should be increased to 2 to 4 mg/kg/day methylprednisolone equivalents and nivolumab must be permanently discontinued.
Danish: Hvis der opstår forværring, eller der ikke sker bedring, på trods af anvendelse af kortikosteroid, skal kortikosteroiddosis øges op til en dosis ækvivalent med 2-4 mg/kg/dag methylprednisolon, og nivolumab skal seponeres permanent.
English: If worsening or no improvement occurs despite initiation of corticosteroids, corticosteroid dose should be increased to 1 to 2 mg/kg/day methylprednisolone equivalents and nivolumab must be permanently discontinued.
Danish: Hvis der opstår forværring, eller der ikke sker bedring, på trods af anvendelse af kortikosteroid, skal kortikosteroiddosis øges op til en dosis ækvivalent med 1-2 mg/kg/dag methylprednisolon, og nivolumab skal seponeres permanent.
English: Grade 2 and Grade 3 cases were reported in 2.8% (7/248) and 1.6% (4/248) of patients, respectively.
Danish: Der blev rapporteret grad 2 og grad 3 tilfælde hos henholdsvis 2,8% (7/248) og 1,6% (4/248) af patienterne.
English: Withhold Nivolumab BMS until symptoms resolve and management with corticosteroids, if needed, is complete
Danish: Nivolumab BMS udsættes, indtil symptomerne forsvinder, og eventuel behandling med kortikosteroid er afsluttet
English: Three patients, including the one patient with Grade 3 adrenal insufficiency, received high-dose corticosteroids (at least 40 mg prednisone equivalents) at a median initial dose of 1.1 mg/kg (range: 0.5-1.3) for 2.7 weeks (range: 0.6-4.6).
Danish: Tre patienter, herunder den ene patient med et grad 3 tilfælde af binyrebarkinsufficiens, fik højdosis kortikosteroid (i en dosis mindst ækvivalent med 40 mg prednison) med en median initialdosis på 1,1 mg/kg (0,5-1,3) i 2,7 uger (0,6-4,6).
English: For Grade 4 serum creatinine elevation, nivolumab must be permanently discontinued, and corticosteroids should be initiated at a dose of 1 to 2 mg/kg/day methylprednisolone equivalents.
Danish: Ved grad 4 forhøjelse af serumkreatinin skal nivolumab seponeres permanent, og kortikosteroid bør initieres med en dosis ækvivalent med 1-2 mg/kg/dag methylprednisolon.
English: After administration of the nivolumab dose, flush the line with sodium chloride 9 mg/mL (0.9%) solution for injection or 50 mg/mL (5%) glucose solution for injection.
Danish: Efter administration af nivolumab-dosis, gennemskylles slangen med natriumchlorid 9 mg/ml (0,9%) injektionsvæske eller glucose 50 mg/ml (5%) injektionsvæske.
English: Immune-related adverse reaction
Danish: Immunrelateret bivirkning
English: For Grade 4 diarrhoea or colitis, nivolumab must be permanently discontinued, and corticosteroids should be initiated at a dose of 1 to 2 mg/kg/day methylprednisolone equivalents.
Danish: Ved grad 4 diarre eller colitis skal nivolumab seponeres permanent og kortikosteroid initieres ved en dosis ækvivalent med 1-2 mg/kg/dag methylprednisolon.
English: Grade 2 and Grade 3 cases were reported in 1.2% (3/248) and 0.4% (1/248) of patients, respectively.
Danish: Grad 2 og grad 3 tilfælde blev rapporteret hos henholdsvis 1,2% (3/248) og 0,4% (1/248) af patienterne.
English: Problems with your lungs such as breathing difficulties or cough.
Danish: Kontakt lægen, før du bruger Nivolumab BMS, da det kan medføre: Problemer med lungerne som f.eks. vejrtrækningsbesvær eller hoste.
English: If you have any further questions, ask your doctor.
Danish: Spørg lægen, hvis der er noget, du er i tvivl om.
English: For Grade 3 diarrhoea or colitis, nivolumab should be withheld and corticosteroids initiated at a dose of 1 to 2 mg/kg/day methylprednisolone equivalents.
Danish: Ved grad 3 diarre eller colitis udsættes nivolumabdosering, og kortikosteroid initieres med en dosis ækvivalent med 1-2 mg/kg/dag methylprednisolon.
English: Name and address of the manufacturer of the biological active substance
Danish: ANSVARLIG FOR BATCHFRIGIVELSE Navn og adresse på fremstilleren af det biologisk aktive stof Lonza Biologics, Inc.
English: Grade 2 and Grade 3 cases were reported in 1.6% (4/248) and 0.8% (2/248) of patients, respectively.
Danish: Grad 2 og grad 3 tilfælde blev rapporteret hos henholdsvis 1,6% (4/248) og 0,8% (2/248) af patienterne.
English: For Grade 3 or 4 transaminase or total bilirubin elevation, nivolumab must be permanently discontinued, and corticosteroids should be initiated at a dose of 1 to 2 mg/kg/day methylprednisolone equivalents.
Danish: Ved grad 3 eller 4 forhøjelse af aminotransferase eller total-bilirubin seponeres nivolumab permanent, og kortikosteroid initieres med en dosis ækvivalent med 1-2 mg/kg/dag methylprednisolon.
English: Grade 2 and Grade 3 cases were reported in 2% (5/248) and 1.6% (4/248) of patients, respectively.
Danish: Grad 2 og grad 3 tilfælde blev rapporteret hos henholdsvis 2% (5/248) og 1,6% (4/248) af patienterne.
English: Sodium citrate dihydrate
Danish: FARMACEUTISKE OPLYSNINGER 6.1 Hjælpestoffer Natriumcitratdihydrat Natriumchlorid
English: Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Danish: Lægemidlet må kun udleveres efter ordination på en recept udstedt af en begrænset lægegruppe (se
English: BRISTOL-MYERS SQUIBB, S.A.
Danish: Bristol-Myers Squibb B.V.
English: Systemic immunosuppression
Danish: Immunrelateret udslæt
English: • At the request of the European Medicines Agency;
Danish: Yderligere oplysninger om dette lægemiddel findes på Det Europæiske Lægemiddelagenturs
English: Preparation and administration of Nivolumab BMS
Danish: Efter administration af nivolumab gennemskylles i.v.
English: Gently mix the infusion by manual
Danish: Blandes forsigtigt ved at
English: These reactions usually disappear within 1-2 days without treatment.
Danish: Disse reaktioner forsvinder normalt i løbet af 1-2 dage uden behandling.
English: EU member states cumulatively and iii)
Danish: EU's medlemsstater kumulativt, og iii)
English: the rest of the world
Danish: resten af verden
English: 1 year.
Danish: 1 år
English: - Report submission is no later than day 22 (i.e. the following Monday).
Danish: - Der indsendes rapport senest på dag 22 (dvs. den følgende mandag).
English: However data suggested that the duration of protection might be shorter.
Danish: Imidlertid tyder data på, at varigheden af beskyttelsen kan være kortere.
English: - All tables will be based on generic and not product-specific data.
Danish: - Alle tabeller baseres på generiske og ikke produktspecifikke data.
English: • if you have a severe infection with a high temperature (over 38°C).
Danish: • hvis du har en voldsom infektion med høj temperatur (over 38 °C).
English: Depending on and after implementation of vaccine when first pandemic will take place.
Danish: Afhængig af og efter implementeringen af vaccine, når den første pandemi finder sted.
English: Do not be alarmed by this list of possible side effects.
Danish: Du må ikke blive forskrækket over denne liste over eventuelle bivirkninger.
English: 15 micrograms**
Danish: 15 mikrogram**
English: See section 4.4.
Danish: Se afsnit 4.4.
English: The Western Blot technique disproves the results.
Danish: Western Blot-teknikken modbeviser resultaterne.
English: Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.emea.europa.eu/
Danish: Der findes yderligere oplysninger om denne medicin på hjemmesiden for EMEA (det europæiske lægemiddelagentur): http://www.emea.europa.eu/
English: Risk Management plan
Danish: Risikohåndteringsplan
English: The vaccine works by causing the body to produce its own protection (antibodies) against the disease.
Danish: Vaccinen virker ved at få kroppen til at producere sin egen beskyttelse (antistoffer) mod sygdommen.
English: Please tell your doctor if you are pregnant.
Danish: Du skal fortælle det til lægen, hvis du er gravid.
English: A minor infection such as a cold should not be a problem, but talk to your doctor first.
Danish: En mindre infektion som eksempelvis en forkølelse behøver ikke at være et problem, men tal med lægen om det først.
English: Pandemic flu is a type of influenza that occurs every few decades and which spreads rapidly to affect most countries and regions around the world.
Danish: Pandemisk influenza er en type influenza, som forekommer med nogle årtiers mellemrum, og som spreder sig hurtigt, så den rammer de fleste lande og områder i hele verden.
English: EU member states for the reporting period by batch number,
Danish: EU's medlemsstater i rapporteringsperioden pr. batchnummer ii)
English: Product-specific data can be evaluated during signal work-up.
Danish: Produktspecifikke data kan vurderes i udredningen af signaler.
English: Official batch release: in accordance with Article 114 Directive 2001/83/EC as amended, the official batch release will be undertaken by a state laboratory or a laboratory designated for that purpose.
Danish: Officiel batchfrigivelse: i overensstemmelse med artikel 114 i Rådets direktiv 2001/83/EØF med ændringer vil den officielle batchfrigivelse blive foretaget af et statsligt laboratorium eller et laboratorium udpeget hertil.
English: All events reported by patients that have been entered into the database by data-lock point 6.
Danish: Alle hændelser, som patienterne har rapporteret, og som er lagt ind i databasen på tidspunktet for data-lock point.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Danish: DATO FOR FØRSTE TILLADELSE / FORNYELSE AF TILLADELSEN AUTHORISATION
English: This means that for scientific reasons, it has not been possible to obtain complete information on this medicinal product.
Danish: Det betyder, at det ikke har været muligt at opnå fuldstændig dokumentation for dette lægemiddel.
English: For further information, see section 5.1.
Danish: For yderligere oplysninger se afsnit 5.1.
English: The transient false positive reactions could be due to the IgM response by the vaccine.
Danish: De forbigående falsk positive reaktioner kan skyldes vaccinens IgM-respons.
English: MARKETING AUTHORISATION NUMBER(S) EU/0/00/000/000
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/0/00/000/000
English: BATCH NUMBER Lot:
Danish: BATCHNUMMER Lot:
English: PSUR submission during the influenza pandemic:
Danish: Indsendelse af PSUR under en influenzapandemi:
English: All events occurring in the following age groups: 6-23 months, 2-8 years, 8-17 years, 18-60 years, >60 years All events occurring in pregnant women 5.
Danish: Alle hændelser opdelt på følgende aldersgrupper: 6 - 23 måneder, 2 - 8 år, 8 - 17 år, 18 - 60 år, > 60 år Alle hændelser hos gravide 5.
English: Format The report shall include the following Tables of aggregate data using the agreed templates: 1.
Danish: Format Rapporten skal omfatte følgende tabeller over samlede data vha. de aftalte skabeloner: 1.
English: Daronrix has been authorised under “Exceptional Circumstances”.
Danish: Daronrix er godkendt under ”særlige omstændigheder”.
English: Other side effects which have occurred in the days or weeks after vaccination with ordinary flu vaccines include:
Danish: De bivirkninger, som er dukket op i dagene eller ugerne efter vaccination med almindelig influenzavaccine, omfatter blandt andre:
English: The immunological response may be diminished if the patient is undergoing immunosuppressant treatment.
Danish: Det immunologiske respons kan nedsættes, hvis patienten er i immunosupprimerende behandling.
English: These antigens can be considered as “novel” antigens and simulate a situation where the target population for vaccination is immunologically naïve.
Danish: Disse antigener kan kaldes ”nye” antigener og simulerer en situation, hvor målpopulationen for vaccinationen er immunologisk naive.
English: A summary of vaccine distribution shall be included and provide details of the number of doses of vaccine distributed in:
Danish: Der skal indgå et resume over vaccinedistributionen og gives nærmere oplysninger om de distribuerede vaccinedoser i:
English: - No line listings are required - these can be provided in signal evaluation reports as necessary.
Danish: - Der kræves ingen ”line listings” - disse kan angives efter behov i evalueringsrapporterne over hændelserne.
English: With interpandemic trivalent vaccines, it is usually 6 - 12 months, but for Daronrix no data are available yet with the H5N1 strain.
Danish: Ved interpandemiske, trivalente vacciner er det sædvanligvis 6-12 måneder, men for Daronrix findes der endnu ingen tilgængelige data med H5N1-stammen.
English: Undesirable effects reported are listed according to the following frequency:
Danish: De indberettede bivirkninger opstilles ud fra følgende hyppighed:
English: A protective immune response may not be elicited in all vaccinees (see section 5.1).
Danish: Det er ikke sikkert, at der opnås beskyttende immunrespons hos alle vaccinerede (se afsnit 5.1).
English: - Tables 1 to 4 will be based on events reported from healthcare professionals only.
Danish: - Tabel 1-4 omfatter kun hændelser, som er rapporteret af sundhedspersonalet.
English: 4.5 Interaction with other medicinal products and other forms of interaction Daronrix should not be given at the same time as other vaccines.
Danish: 4.5 Interaktion med andre lægemidler og andre former for interaktion Daronrix må ikke gives på samme tid som andre vacciner.
English: The symptoms of pandemic flu are similar to those of “ordinary” flu but are usually more severe.
Danish: Symptomerne på en pandemisk influenza er de samme som ved en "ordinær" influenza, men er normalt voldsommere.
English: Antibody response in patients with endogenous or iatrogenic immunosuppression may be insufficient.
Danish: Antistofresponset hos patienter med endogen eller iatrogen immunosuppression kan være utilstrækkeligt.
English: - In Tables 1 to 5, numbers will be provided for events received during the reporting period and cumulatively.
Danish: - I tabel 1-5 vises antal hændelser i rapporteringsperioden og kumulativt.
English: Mock-up vaccines contain influenza antigens that are different from those in the currently circulating influenza viruses.
Danish: Mockup-vacciner indeholder influenzaantigener, som er anderledes end dem, der findes i den influenzavirus, der er i omløb for indeværende.
English: Prophylaxis of influenza in an officially declared pandemic situation.
Danish: Influenzaprofylakse ved en officielt deklareret pandemisk situation.
English: It is possible that you have no side effects from vaccination.
Danish: Måske får du slet ingen bivirkninger af vaccinationen.
English: Pharmacotherapeutic group: Influenza vaccines, ATC Code J07BB01.
Danish: Farmakoterapeutisk klassifikation: Influenzavacciner, ATC-kode J07BB01.
English: - All tables will be based on number of events (presented on PT level, sorted by System Organ Class [SOC]) and not number of cases.
Danish: - Alle tabeller baseres på antal hændelser (med foretrukket term, opført efter organklasser (SOC)) og ikke antal tilfælde.
English: Dispose of in accordance with local regulations.
Danish: Bør destrueres i henhold til lokale retningslinjer.
English: • Severe stabbing or throbbing pain along one or more nerves
Danish: • Stærke stikkende eller dunkende smerter langs en eller flere nerver
English: The MAH must ensure that the system of pharmacovigilance is in place and functioning before the product is placed on the market and for as long as the marketed product remains in use.
Danish: Indehaveren af markedsføringstilladelsen skal sikre, at farmakovigilance-systemet er på plads og fungerer, før produktet når markedet, og lige så længe som det markedsførte produkt anvendes.
English: Pharmacovigilance system
Danish: Farmakovigilance-system
English: Serious unexpected reactions (PTs) 4.
Danish: Alvorlige, uventede reaktioner (foretrukne termer) 4.
English: For pregnant women, see section 4.6.
Danish: For gravide kvinder, se afsnit 4.6.
English: Infections and infestations Uncommon: nasopharyngitis, rhinitis
Danish: Infektioner og infestationer Ikke almindelig: nasofaryngitis, rhinitis
English: For adjuvants, see section 2.
Danish: Vedrørende adjuvanser, se afsnit 2.
English: In circumstances when a fast onset of protection is needed, a third dose might therefore be necessary to ensure duration of protection.
Danish: Under omstændigheder der kræver hurtig beskyttelse er nødvendig, kan det derfor være nødvendigt med en tredje dosis for at sikre varigheden.
English: A cumulative overview of all events reported during the period, stratified according to type of reporter (patient or health care professional), seriousness, expectedness, and whether spontaneous or solicited.
Danish: En samlet oversigt over alle hændelser, som er rapporteret i perioden, opdelt ud fra hvem der har rapporteret dem (patient eller sundhedspersonale), alvor, forventelighed og om rapporteringen var spontan eller kom på opfordring.
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Danish: Ønsker du yderligere oplysninger om dette lægemiddel, bedes henvendelse rettet til den lokale repræsentant for indehaveren af markedsføringstilladelsen:
English: Do not use Daronrix after the expiry date which is stated on the carton.
Danish: Brug ikke Daronrix efter den udløbsdato, der står på pakningen.
English: If you take any medicines that reduce immunity to infections or have any other type of treatment (such as radiotherapy) that affects the immune system, Daronrix can still be given but your response to the vaccine may be poor.
Danish: Hvis du tager medicin, som reducerer immunforsvaret over for infektioner eller får en anden behandling (fx strålebehandling), som påvirker immunsystemet, kan Daronrix stadig gives, men dit respons på vaccinen kan være dårlig.
English: This medicinal product contains thiomersal (an organomercuric compound) as a preservative and therefore, it is possible that sensitisation reactions may occur (see section 4.4).
Danish: Dette lægemiddel indeholder thiomersal (en organisk kviksølvsforbindelse) som konserveringsmiddel, og det er derfor muligt, at der kan forekomme overfølsomhedsreaktioner (se afsnit 4.4).
English: These results indicated that higher antigen content may be needed in subjects above 60 years of age as compared to an adult population (18-60 years) in order to ensure optimal protection.
Danish: Disse resultater viser, at det kan være nødvendigt med et højere antigenindhold til personer over 60 år sammenlignet med populationen på mellem 18 og 60 år for at sikre optimal beskyttelse.
English: Presentation of data will take into consideration the following recommendations: - Serious expected reactions will be reviewed by the MAH as part of their signal detection procedures and will only form part of the report if an issue of concern arises.
Danish: Præsentationen af data skal tage følgende anbefalinger i betragtning: - Alvorlige, forventede reaktioner vurderes af indehaveren af markedsføringstilladelsen som en del af evalueringsprocedurerne og vil kun indgå i rapporten, hvis et alvorligt tilfælde opstår.
English: If the pandemic situation allows, immunisation shall be postponed in patients with severe febrile illness or acute infection.
Danish: Hvis den pandemiske situation tillader det, skal vaccinationen af patienter med svær, febril sygdom eller akut infektion udsættes.
English: Seroprotection rate*
Danish: Seroprotektionsværdi*
English: What Daronrix contains - The active substances are:
Danish: Daronrix indeholder - Aktivt stof:
English: During a pandemic situation, the frequency of submission of periodic safety update reports specified in Article 24 of Regulation (EC) No 726/2004 will not be adequate for the safety monitoring of a pandemic vaccine for which high levels of exposure are expected within a short period of time.
Danish: Under en pandemi er frekvensen for indsendelse af PSUR som nævnt i artikel 24 i EU's forordning nr. 726/2004 ikke relevant i forbindelse med sikkerhedsmonitorering af en pandemisk vaccine, hvor patienterne forventes at blive udsat for høj smitte i løbet af kort tid.
English: This section describes the clinical experience with the mock-up vaccines following a two-dose administration.
Danish: Dette afsnit beskriver den kliniske erfaring med mockup-vacciner efter indgift af 2 doser.
English: 21 days after 2nd dose
Danish: 21 dage efter anden dosis
English: Following influenza vaccination, false positive results in serology tests using the ELISA method to detect antibodies against HIV-1, Hepatitis C and especially HTLV-1 have been observed.
Danish: Efter influenzavaccination er der set falsk positive resultater ved serologitest med ELISA i forbindelse med antistoffer mod HIV-1, hepatitis C og især HTLV-1.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING AMPOULE X 100
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE AMPUL X 100