FrancophonIA/ELRC3.0 huggingface dataset:
English: • The PRAC considered, after having reviewed the available data that tetrazepam, compared to the medicines of the same pharmacological class, is associated with an increased risk of serious cutaneous adverse reactions including Stevens-Johnson syndrome, Toxic Epidermal Necrolysis , Erythema Multiform and Drug Reaction of Eosinophilia Systemic Symptoms (DRESS) which can be life threatening and fatal.
Danish: • efter gennemgang af de foreliggende data fandt PRAC, at tetrazepam i forhold til andre lægemidler af samme farmakologiske klasse er forbundet med højere risiko for alvorlige kutane bivirkninger, som kan være livstruende og fatale, herunder Stevens-Johnsons syndrom, toksisk epidermal nekrolyse, erythema multiforme og lægemiddelfremkaldt udslæt med eosinofili og systemiske symptomer (DRESS),
English: Tetrazepam is a benzodiazepine indicated for painful contractures in rheumatology and in spastic syndromes across the Members States.
Danish: Tetrazepam er et benzodiazepin, der i en række EU-medlemsstater er indiceret til smertefulde kontrakturer ved reumatologiske og spastiske lidelser.
English: Acute generalised exanthematous pustulosis due to tetrazepam.
Danish: Akut generaliseret eksantematøs pustulose som følge af tetrazepam.
English: • The PRAC considered the totality of the data available for tetrazepam containing products in relation to the risk of cutaneous adverse reactions.
Danish: • PRAC gennemgik samtlige foreliggende data vedrørende risikoen for kutane bivirkninger med produkter indeholdende tetrazepam.
English: J Investig Allergol Clin Immunol 2008;18(5):404-406 9 Blanco R et la.
Danish: J Investig Allergol Clin Immunol 2008;18(2):119-122
English: Overall, the efficacy of tetrazepam in the painful contractures indication is supported mainly by two small double blind placebo-controlled clinical trial (Arbus 1987
Danish: Virkningen af tetrazepam ved indikationen smertefulde kontrakturer er hovedsagelig dokumenteret ved to små dobbeltblindede, placebokontrollerede kliniske undersøgelser (Arbus 1987 og Salzmann 1993) med i alt 70 patienter (henholdsvis 50 patienter og 20 patienter).
English: The CMDh, having considered the PRAC recommendation dated 11 April 2013 with regards to the tetrazepam containing medicinal products, agrees with the recommendation therein as stated below:
Danish: CMDh (koordinationsgruppen vedrørende gensidig anerkendelse og decentraliserede procedurer (human)) har gennemgået PRAC's (Udvalget for Risikovurdering inden for Lægemiddelvurdering) anbefaling af 11. april 2013 for lægemidler indeholdende tetrazepam, og CMDh kan tilslutte sig anbefalingen, således som det fremgår af følgende:
English: Tetrazepam was the only suspected drug or had a causality score higher than the concomitant treatments in 18 out 81 cases of SJS, TEN or DRESS.
Danish: I 18 af de 81 tilfælde af SJS, TEN og DRESS var tetrazepam det eneste mistænkte lægemiddel eller havde højere kausalitetsscore end de samtidigt anvendte lægemidler.
English: The PRAC considered that the risk minimisations measures discussed during the assessment, including reduction of duration of treatment and restricted indication, were not sufficient to reduce the risk.
Danish: De risikominimeringsforanstaltninger, der blev drøftet under vurderingen, herunder nedsættelse af behandlingsvarigheden og indskrænkning af indikationerne, fandt PRAC ikke tilstrækkelige til at mindske risikoen.
English: A specific analysis about the most relevant serious adverse cutaneous reactions reported by the MAH in relationship of their nature and severity was made in the MAH's response to the PRAC list of questions.
Danish: Markedsføringstilladelsesindehaverens besvarelse af spørgsmålene fra PRAC indeholdt en konkret analyse af arten og sværheden af de mest relevante alvorlige uønskede kutane reaktioner, som var indberettet af markedsføringstilladelsesindehaveren.
English: The PRAC considered that the available efficacy data, including data which became available since the initial marketing authorisation, showed only very limited clinical efficacy of tetrazepam in its approved indications.
Danish: PRAC fandt, at de foreliggende data kun viser meget begrænset klinisk virkning af tetrazepam ved de godkendte indikationer.
English: • The PRAC considered that the available efficacy data, including data which became available since the initial marketing authorisation, showed only very limited clinical efficacy of tetrazepam in its approved indications.
Danish: • PRAC fandt, at de foreliggende data kun viser meget begrænset klinisk virkning af tetrazepam ved de godkendte indikationer.
English: Contact Dermatitis 1998 ;39(2):84
Danish: J Eur Acad Dermatol Venereol 2008;22(7):887-8
English: This evaluation highlighted an increased cutaneous risk of tetrazepam in addition to the pharmacological expected ADRs of benzodiazepines: half of the ADRs reported with tetrazepam were cutaneous and amongst the 648 serious cases reported, 305 cases were reported under the System Organ Class (SOC) “Skin and subcutaneous disorders”: 33 cases of Stevens - Johnson syndrome (SJS), 33 of Toxic Epidermal Necrolysis (TEN), 59 Erythema Multiforme (EM) and 15 cases of Drug Reaction (or Rash) with Eosinophilia and Systemic Symptoms (DRESS Syndrome) were detected with fatal outcome in 11 cases.
Danish: Vurderingen viste større kutan risiko med tetrazepam end forventeligt for farmakologisk betingede bivirkninger af benzodiazepiner: Halvdelen af de indberettede bivirkninger med tetrazepam var kutane, og af 648 alvorlige indberettede tilfælde var der 305 tilfælde under systemorganklassen “Hud og subkutane væv”.
English: However the imputability of tetrazepam is strong in a high number of cases.
Danish: Et stort antal tilfælde må dog med overvejende sandsynlighed tilskrives tetrazepam.
English: 4 Bachmeyter C. Probable drug rash with eosinophilia and systemic symptoms syndrome related to tetrazepam.
Danish: Contact Dermatitis 1998 ;39(2):84 Bachmeyter C. Formodet lægemiddeludslæt med eosinofili og systemiske symptomer (DRESS) relateret til tetrazepam.
English: 3 Quinones D et al. Photodermatitis from tetrazepam.
Danish: 5 Cabreizo Ballesteros et al. Erythema multiforme fremkaldt af tetrazepam.
English: International Journal of Dermatology 2006;45(4):480 Del Pozo MD et al. Tetrazepam Allergy.
Danish: Contact Dermatitis 1990;22:246 3 Quinones D et al. Fotodermatitis forårsaget af tetrazepam.
English: Allergol Immunopathol 1998;26:55-57
Danish: Allergol Immunopathol 1998;26:55-57 2 Camarasa JG et al. Tetrazepam-allergi opdaget gennem lappeprøve.
English: 2 Camarasa JG et al. Tetrazepam allergy detected by patch test.
Danish: Del Pozo MD et al. tetrazepam Allergy.
English: Toxic epidermal necrolysis caused by tetrazepam.
Danish: Delesalle F et la. Toksisk epidermal nekrolyse forårsaget af tetrazepam.
English: What should I do with this card?
Danish: Hvad skal jeg gøre med dette kort?
English: What else do I need to know?
Danish: Hvad har jeg ellers brug for at vide?
English: This card tells you:
Danish: Dette kort fortæller dig:
English: Where can I get more information?
Danish: Hvor kan jeg få mere information?
English: Not known (it is not known how often these side effects happen):
Danish: Ikke kendt (det vides ikke, hvor ofte disse bivirkninger forekommer):
English: No additional safety signals were identified.
Danish: Der var ikke identificeret yderligere sikkerhedssignaler.
English: However, the possible risk for the development of solid tumours cannot be excluded at this time.
Danish: En potentiel risiko for udvikling af solide tumorer kan dog ikke udelukkes på nuværende tidspunkt.
English: These can be complemented with other appropriate markers as per local guidelines.
Danish: Der kan suppleres med andre passende markører i henhold til lokale retningslinjer.
English: Care must be taken to ensure the sterility of prepared solutions.
Danish: Der skal udvises omhu for at sikre steriliteten af de tilberedte opløsninger.
English: At minimum this should include HBsAg-status and HBcAb-status.
Danish: Som minimum bør dette inkludere HBsAg-status og HBcAb-status.
English: Date of first authorisation: 13 July 2017 Date of latest renewal:
Danish: Dato for første markedsføringstilladelse: 13. juli, 2017 Dato for seneste fornyelse:
English: The pre-specified non-inferiority margin for the treatment difference was 20%.
Danish: Den præspecificerede non-inferioritetsmargin for behandlingsforskel var 20 %.
English: This is usually given every 3 weeks up to 8 times.
Danish: Det vil sædvanligvis sige hver 3. uge, op til 8 gange.
English: • if you think you may need any vaccinations in the near future, including vaccinations needed to travel to other countries.
Danish: • hvis du tror, du måske har brug for at blive vaccineret i nær fremtid, inklusive vaccinationer for at rejse til andre lande.
English: When should I not have Ritemvia?
Danish: Hvornår må jeg ikke få Ritemvia?
English: In particular, tell your doctor:
Danish: Det er særligt vigtigt at fortælle lægen:
English: Median FU, months
Danish: Median FU, måneder
English: These patients should be very closely monitored throughout the first infusion.
Danish: Disse patienter bør overvåges meget tæt under hele første infusion.
English: From a microbiological point of view, the prepared infusion solution should be used immediately.
Danish: Fra et mikrobiologisk synspunkt skal den tilberedte infusionsopløsning anvendes umiddelbart.
English: • Pain without injuring yourself
Danish: • Smerter uden at du er kommet til skade
English: • What to do if you think you might be getting an infection.
Danish: • Hvad du skal gøre, hvis du tror, at du er ved at få en infektion
English: Read this leaflet carefully before you start taking this medicine because it contains important information for you.
Danish: Læs denne indlægsseddel grundigt, inden du begynder at få dette lægemiddel, da den indeholder vigtige oplysninger.
English: • you have a severe active infection at the moment
Danish: • du i øjeblikket har en aktiv svær infektion
English: • The importance of sharing this information with their partner or caregiver
Danish: • Vigtigheden af at dele denne information med deres evt. partner eller omsorgsperson
English: Complete remission at 12 and 18 months
Danish: Fuldstændig remission ved måned 12 og 18
English: Key results from all four studies are summarised in Table 6.
Danish: Nøgleresultater fra alle fire studier er opsummeret i tabel 6.
English: The primary endpoint was the proportion of patients who achieved an ACR20 response at week 24.
Danish: Det primære endepunkt var andelen af patienter, der opnåede et ACR20-respons ved uge 24.
English: Two patients were re-treated twice in the study.
Danish: To patienter blev genbehandlet to gange under studiet.
English: • The need for close supervision during administration in an environment where full resuscitation facilities are immediately available
Danish: • Nødvendigheden af tæt overvågning under administration i omgivelser, hvor komplet genoplivningsudstyr er umiddelbart tilgængeligt
English: These cases occurred in non-approved indications and the majority of patients were HIV positive.
Danish: Disse tilfælde forekom hos ikke-godkendte indikationer, og de fleste patienter var hiv-positive.
English: 2) Last tumour response as assessed by the investigator.
Danish: 2) Seneste tumorrespons bedømt af investigator.
English: B-lymphocytes are involved in the cause of these conditions.
Danish: B-lymfocytter er involveret i årsagen til disse tilstande.
English: The risk of disease progression was reduced by 46% and the risk of relapse by 51%.
Danish: Risikoen for sygdomsprogression blev reduceret med 46 % og risikoen for relaps med 51 %.
English: Survival Time (Months)
Danish: Overlevelsestid (måneder)
English: Most side effects are mild to moderate but some may be serious and require treatment.
Danish: De fleste bivirkninger er lette til moderate men nogle kan være alvorlige og kræve behandling.
English: • Information that the product should be administered as IV only to avoid administration route errors.
Danish: • Information om, at præparatet kun må administreres intravenøst for at undgå forkerte administrationsveje.
English: Study Treatment, N
Danish: Studie Behandling, N
English: • if you think you may have an infection, even a mild one like a cold.
Danish: • hvis du tror, du måske har en infektion, selv en mild form som for eksempel en forkølelse.
English: p-value (Wald test, not adjusted)
Danish: p-værdi (Wald test, ikke justeret)
English: This is because side effects can develop several months after you have had treatment.
Danish: Dette skyldes, at bivirkningerne kan forekomme flere måneder efter, du har fået behandling.
English: They will watch you closely while you are being given this medicine.
Danish: De vil overvåge dig, mens du får medicinen.
English: Outcome†
Danish: Resultat†
English: 4 Includes observations collected as part of routine laboratory monitoring.
Danish: 4 Herunder observationer, som var indsamlet som en del af rutinemæssig laboratorie-overvågning
English: 38 months
Danish: 38 måneder
English: • high or low blood pressure (low blood pressure especially when standing upright)
Danish: • højt eller lavt blodtryk (lavt blodtryk særligt når du rejser dig op)
English: • Keep this card with you all the timesuch as in your wallet or purse.
Danish: • Opbevar altid dette kort på dig - f.eks. i din tegnebog eller pung
English: These are listed below under “Other side effects”.
Danish: Disse er angivet under ”Andre bivirkninger”.
English: The median follow up of patients was 53 months.
Danish: Den mediane opfølgningstid for patienterne var 53 måneder.
English: Induction of remission
Danish: Induktion af remission
English: • allergic reactions (hypersensitivity)
Danish: • allergiske reaktioner (overfølsomhed)
English: • The need to carry the card at all times and to show the card to all treating health care professionals
Danish: • Nødvendigheden af altid at have kortet på sig og at vise kortet til alt behandlende sundhedspersonale
English: 95.1%b CI (−3.2%, 24.3%) a
Danish: 95,1 %b konfidensinterval (−3,2 %; 24,3 %) a
English: These findings were replicated at Week 48, where autoantibody seropositivity also significantly increased the probability of achieving ACR70.
Danish: Disse resultater blev gentaget ved uge 48, hvor autoantistof-seropositivitet også signifikant øgede sandsynligheden for at opnå ACR70.
English: • if you are taking medicines for high blood pressure.
Danish: • om du tager medicin mod forhøjet blodtryk.
English: It is important that you keep this Alert Card and show it to your partner or caregiver.
Danish: Det er vigtigt, at du gemmer dette kort og viser det til din partner eller hjælper.
English: Also please tell your doctor if you had a lot of infections in the past or suffer from severe infections.
Danish: Fortæl også lægen, hvis du tidligere har haft mange infektioner eller lider af alvorlige infektioner
English: Do not have Ritemvia if you have an active infection or a serious problem with your immune system.
Danish: Du må ikke få Ritemvia, hvis du har en aktiv infektion eller alvorlige problemer med dit immunsystem.
English: Ritemvia may be used for the treatment of several different conditions in adults.
Danish: Ritemvia kan anvendes til behandling af flere forskellige tilstande hos voksne.
English: Time to new CLL treatment
Danish: Tid indtil ny CLL behandling
English: Very Rare Not known
Danish: Meget sjælden Ikke kendt
English: • If you are having Ritemvia alone
Danish: • Hvis du får Ritemvia alene
English: To be taken into consideration by patients on a controlled sodium diet.
Danish: Dette bør tages i betragtning for patienter på en kontrolleret natriumdiæt.
English: The final efficacy analysis included all patients randomised to both parts of the study.
Danish: Den endelige effektanalyse inkluderede alle patienter randomiseret til begge dele af studiet.
English: • tremors (shakiness, often in the hands)
Danish: • rysten (ofte på hænderne)
English: When these symptoms go away, or improve, the infusion can be continued.
Danish: Når disse symptomer forsvinder eller forbedres, kan infusionen fortsættes.
English: This is in case you get any side effects.
Danish: Dette er i tilfælde af, at du skulle få bivirkninger.
English: Currently, there are limited data on possible drug interactions with rituximab.
Danish: På nuværende tidspunkt er der begrænsede data om mulige lægemiddelinteraktioner med rituximab.
English: Excipients with known effects:
Danish: Hjælpestoffer med kendte virkninger:
English: - * Worst case imputation a Non-inferiority was demonstrated since the lower bound (−3.2%) was higher than the pre-determined non-inferiority margin (− 20%).
Danish: *Værst tænkelige ekstrapolering a Der blev vist non-inferioritet, idet den nedre grænse (−3,2 %) var højere end den forud fastsatte non inferioritetsmargin (−20 %).
English: Standard tests to investigate mutagenicity have not been carried out, since such tests are not relevant for this molecule.
Danish: Der er ikke gennemført standard mutagenicitettest, da sådanne test ikke er relevante for dette molekyle.
English: The gender-related pharmacokinetic differences are not considered to be clinically relevant and dose adjustment is not required.
Danish: Den kønsrelaterede farmakokinetiske forskel anses ikke for at være klinisk relevant, og dosisjustering er ikke nødvendig.
English: Ritemvia is a biosimilar medicinal product.
Danish: Ritemvia er et biosimilært lægemiddel.
English: Of 67 patients evaluated for human anti-mouse antibody (HAMA), no responses were noted.
Danish: Hos 67 patienter, der blev vurderet for humant anti-mus antistof (HAMA), fandtes intet respons.
English: 1) Estimates were calculated by hazard ratios
Danish: 1) Estimater beregnet ved hazard ratio
English: It also includes your name and doctor's name and phone number on the back.
Danish: På bagsiden oplyser kortet også om dit navn samt din læges navn og telefonnummer.
English: Of 356 patients evaluated for anti-drug antibody (ADA), 1.1% (4 patients) were positive.
Danish: Af 356 patienter, der blev vurderet for anti-lægemiddel antistof (ADA), var 1,1 % (4 patienter) positive.
English: 20 Academy-ro 51 beon-gil Yeonsu-gu, Incheon, 22014, Republic of Korea
Danish: 20 Academy-ro 51 beon-gil Yeonsu-gu, Incheon, 22014, Republikken Korea
English: Do not have Ritemvia if any of the above apply to you.
Danish: Du må ikke få Ritemvia, hvis ét eller flere af ovenstående punkter gælder for dig.
English: The incidence of serious infections was similar in both arms (approximately 12%).
Danish: Forekomsten af alvorlige infektioner var sammenlignelig i begge arme (cirka 12 %).
English: There was no cumulative toxicity in terms of infections reported over a 2-year treatment period.
Danish: Der blev ikke rapporteret om kumulativ toksicitet med hensyn til infektioner i en behandlingsperiode på 2 år.
English: Ritemvia will be given to you once a week for 4 weeks.
Danish: Ritemvia gives en gang ugentligt i 4 uger.
English: Ritemvia is indicated in adults for the following indications:
Danish: Ritemvia er indiceret hos voksne til følgende indikationer:
English: For these reasons rituximab should not be administered to pregnant women unless the possible benefit outweighs the potential risk.
Danish: Derfor bør rituximab ikke gives til gravide kvinder, medmindre den potentielle gevinst opvejer den potentielle risiko.
English: When rituximab sticks to the surface of this cell, the cell dies.
Danish: Når rituximab bindes til overfladen af denne celle, dør cellen til at dø.
English: * at end of maintenance/observation; final analysis results based on median follow-up of 73 months.
Danish: * Ved udgangen af vedligeholdelse/observation: resultaterne fra den finale analyse er baseret på en median observationstid på 73 måneder.
English: Abbreviation: NS, non significant
Danish: Forkortelser: NS = ikke signifikant
English: Infections Tell your doctor immediately if you get signs of an infection including:
Danish: Infektioner Kontakt straks lægen, hvis du får tegn på infektion, f.eks.:
English: Some vaccines should not be given at the same time as Ritemvia or in the months after you receive Ritemvia.
Danish: Nogle vaccinationer bør ikke gives på samme tid som Ritemvia eller i månederne efter du har fået Ritemvia.
English: Elderly patients (≥ 65 years):
Danish: Ældre (≥ 65 år):
English: There was no difference between the treatment groups in the incidence of other thromboembolic events.
Danish: Der var ingen forskel mellem behandlingsgrupperne med hensyn til hyppigheden af andre tromboemboliske hændelser.
English: Your doctor may decide to treat you longer with Ritemvia (up to 5 years), depending on how you respond to the medicine.
Danish: Din læge kan beslutte at behandle dig i længere tid med Ritemvia (op til 5 år), alt efter hvor godt du reagerer på medicinen.
English: The transient IgM increase usually returned to at least baseline level within 4 months.
Danish: Den forbigående stigning i IgM vender normalt tilbage til baseline inden 4 måneder.
English: 5 Includes fatal cases
Danish: 5 Inklusive dødelige tilfælde
English: Significant improvement in health related quality of life was also demonstrated with significant improvement in both the physical health score (PHS) and mental health score (MHS) of the SF-36.
Danish: Signifikant forbedring i helbredsrelateret livskvalitet blev også vist med signifikant forbedring i både den fysiske helbredsscore (PHS) og den mentale helbredsscore (MHS) i SF-36.
English: A slight but not significant improvement in overall survival was reported in the R-FC compared to the FC arm.
Danish: En lille men ikke signifikant forbedring for den samlede overlevelse blev rapporteret i R-FC-armen i forhold til FC-armen.
English: b The 95.1% confidence level reflects an additional 0.001 alpha to account for an interim efficacy analysis.
Danish: b Konfidensintervallet på 95,1 % afspejler et yderligere 0,001 alfa for at tage højde for en interims effektanalyse
English: Since the medicinal product does not contain any anti-microbial preservative or bacteriostatic agents, aseptic technique must be observed.
Danish: Eftersom lægemidlet ikke indeholder noget antimikrobielt konserveringsmiddel eller bakteriostatiske midler skal aseptiske procedurer observeres.
English: Before you are given Ritemvia, you will be given other medicines (pre-medication) to prevent or reduce possible side effects.
Danish: Inden du får Ritemvia, vil du få anden medicin (præmedicin), der forebygger eller mindsker mulige bivirkninger.
English: Proportion of patients with no erosive change
Danish: Andel af patienter uden erosionsforandringer
English: 9.32 years
Danish: 9,32 år
English: The ADRs identified only during post-marketing surveillance, and for which a frequency could not be estimated, are listed under “not known”.
Danish: De bivirkninger, som kun er set under overvågning efter markedsføring, og for hvilke, der ikke kunne beregnes en hyppighed, er anført under ”ikke kendt”.
English: You may require additional treatment such as an antihistamine or paracetamol.
Danish: Du kan behøve yderligere behandling som antihistamin eller paracetamol.
English: IgG levels
Danish: IgG-niveauer
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 °C - 8 °C, unless dilution has taken place in controlled and validated aseptic conditions.
Danish: Hvis den ikke anvendes straks, er opbevaringstid og -forhold inden anvendelse brugerens ansvar og vil normalt ikke være længere end 24 timer ved 2 °C - 8 °C, med mindre opløsningen har fundet sted under kontrollerede og validerede aseptiske forhold.
English: Patients should also be advised to inform their partner or caregivers about their treatment, since they may notice symptoms that the patient is not aware of.
Danish: Patienten bør også rådes til at informere deres pårørende eller plejepersonale om behandlingen, idet de måske opdager symptomer, som patienten ikke selv er klar over.
English: Azathioprine 0 0 3 3 5 5 8 8 9 9 9 10 13 15 17 Rituximab 0 0 0 0 1 1 1 1 1 1 1 1 3 3 3 Number of subjects at risk
Danish: Azathioprin 0 0 3 3 5 5 8 8 9 9 9 10 13 15 17 Rituximab 0 0 0 0 1 1 1 1 1 1 1 1 3 3 3 Antal af patienter i risiko