FrancophonIA/ELRC3.0 huggingface dataset:
English: The review was first conducted by the Pharmacovigilance Risk Assessment Committee (PRAC), the Committee responsible for the evaluation of safety issues for human medicines, which made a set of recommendations.
Danish: Gennemgangen blev først foretaget af Det Rådgivende Udvalg for Risikovurdering inden for Lægemiddelovervågning (PRAC), som har ansvar for vurdering af sikkerhedsspørgsmål vedrørende humanmedicinske lægemidler, og som fremsatte et sæt anbefalinger.
English: Although the majority of cases occurred in patients taking concomitant medications, the causal link with tetrazepam was strong in a high number of cases.
Danish: Skønt størstedelen forekom hos patienter, der samtidig fik anden medicinering, var årsagssammenhængen med tetrazepam stærk i et stort antal tilfælde.
English: The CMDh agreed with the PRAC conclusion that the benefits of these medicines do not outweigh their risks, and adopted a final position that the marketing authorisations should be suspended throughout the EU.
Danish: CMDh tilsluttede sig PRAC's konklusion om, at fordelene ved disse lægemidler ikke opvejer risiciene, og vedtog som sit endelige standpunkt, at markedsføringstilladelserne burde suspenderes i hele EU.
English: The efficacy of tetrazepam for painful contractures is supported mainly by two small double-blind placebo-controlled clinical trials showing limited efficacy.
Danish: Virkningen af tetrazepam ved smertefulde kontrakturer er hovedsageligt baseret på to små dobbeltblindede, placebokontrollerede kliniske undersøgelser, der viser begrænset virkning.
English: • The risk of skin reaction is higher with tetrazepam than with other benzodiazepines.
Danish: • Risikoen for hudreaktioner er større med tetrazepam end med andre benzodiazepiner.
English: Tetrazepam-containing medicines suspended across the EU
Danish: Lægemidler indeholdende tetrazepam suspenderet i EU
English: As tetrazepam-containing medicines are all authorised nationally, the PRAC recommendations were sent to the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh), which adopted a final position.
Danish: Da lægemidler indeholdende tetrazepam alle er godkendt nationalt, blev PRAC's anbefalinger fremsendt til Koordinationsgruppen vedrørende gensidig anerkendelse og decentral procedure - lægemidler til mennesker (CMDh), som tog et endeligt standpunkt.
English: By increasing GABA activity, benzodiazepines have a calming effect on various functions of the brain.
Danish: Ved at øge aktiviteten af GABA virker benzodiazepiner beroligende på en række funktioner i hjernen.
English: Tetrazepam belongs to a group of medicines called benzodiazepines.
Danish: Tetrazepam tilhører lægemiddelgruppen benzodiazepiner.
English: • If you are taking a tetrazepam-containing medicine, you should not suddenly stop taking tetrazepam without your doctor's advice.
Danish: • Hvis du får et lægemiddel, der indeholder tetrazepam, skal du ikke pludselig holde op med at tage tetrazepam, før du har rådført dig med lægen.
English: • Regarding its efficacy, four studies showed no difference between tetrazepam and other active medicines when used for spasticity.
Danish: • Hvad angår terapeutisk virkning viser fire undersøgelser ikke forskel mellem tetrazepam og andre aktive stoffer til behandling af spasticitet.
English: This is possibly explained by a structural difference between tetrazepam and other benzodiazepines (i.e. the substituted cyclohexenyl ring of tetrazepam).
Danish: • Dette kan antagelig forklares ved en strukturel forskel mellem tetrazepam og andre benzodiazepiner (den substituerede cyclohexenylring i tetrazepam).
English: • Pharmacists should refer patients on a new or repeat prescription for tetrazepam to their treating physician.
Danish: • Apoteket bør henvise patienter, medbringer en ny eller fornyet recept for tetrazepam til deres læge.
English: Serious skin reactions include Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), erythema multiforme and drug rash with eosinophilia and systemic symptoms (DRESS) syndrome.
Danish: De alvorlige hudreaktioner omfatter Stevens-Johnsons syndrom (SJS), toksisk epidermal nekrolyse (TEN), erythema multiforme og DRESS-syndrom (lægemiddeludslæt med eosinofili og systemiske symptomer).
English: The CMDh position is based on the PRAC review of all available data on the risk of skin reactions with tetrazepam, including post-marketing data in the EU and the published literature, and the available information on efficacy in licensed indications:
Danish: CMDh's standpunkt er baseret på PRAC's gennemgang af alle foreliggende data om risikoen for hudreaktioner med tetrazepam, herunder erfaringer efter markedsføring i EU og den publicerede litteratur samt de foreliggende oplysninger om virkningen ved de godkendte indikationer:
English: The Committee also noted that, in the light of the risks identified, the available data on the effectiveness of tetrazepam were not sufficiently robust to support its use in the authorised indications.
Danish: På baggrund af de påviste risici konstaterede udvalget desuden, at de foreliggende data om virkningen af tetrazepam ikke var fyldestgørende som grundlag for dets anvendelse til de godkendte indikationer.
English: The review of tetrazepam was triggered by the French National Agency for the Safety of Medicine and Health Products (ANSM), following reports of serious skin reactions with this medicine in France.
Danish: Gennemgangen af tetrazepam skete på foranledning af den franske lægemiddelstyrelse (ANSM) efter indberetninger om alvorlige hudreaktioner med dette lægemiddel i Frankrig.
English: • As a result of the risk of unpredictable, serious skin reactions identified, tetrazepam-containing medicines will no longer be available in the EU.
Danish: • Som følge af den fundne risiko for uforudsigelige alvorlige hudreaktioner vil lægemidler indeholdende tetrazepam ikke længere blive markedsført i EU.
English: The CMDh, a body representing EU Member States, is responsible for ensuring harmonised safety standards for medicines authorised via national marketing authorisation procedures across the EU.
Danish: CMDh er et organ, der repræsenterer EU's medlemsstater og har ansvar for at sikre harmoniserede sikkerhedsnormer i EU for lægemidler gennem nationale procedurer for godkendelse af markedsføringstilladelser.
English: Having assessed all available data on the risk of skin reactions, including post-marketing data in the EU and the published literature, the PRAC concluded that tetrazepam is associated with a low but increased risk of serious skin reactions (including Stevens-Johnson syndrome, toxic epidermal necrolysis and DRESS syndrome) compared with other benzodiazepines.
Danish: Efter at have gennemgået alle foreliggende data om risikoen for hudreaktioner, herunder oplysninger efter markedsføring i EU og fra den publicerede litteratur, konkluderede PRAC, at tetrazepam er forbundet med en risiko for alvorlige hudreaktioner (herunder Stevens-Johnsons syndrom, toksisk epidermal nekrolyse og DRESSsyndrom), som er lav, men højere end med andre benzodiazepiner.
English: In view of the serious, potentially fatal, skin reactions and the limited efficacy of tetrazepam, the benefit-risk balance of tetrazepam-containing medicines is considered no longer favourable.
Danish: I betragtning af de alvorlige, hudreaktioner, potentielt med dødelig udgang, og den begrænsede virkning af tetrazepam er benefit/risk-forholdet for lægemidler indeholdende tetrazepam ikke længere positivt.
English: As the CMDh position was adopted by majority vote, the CMDh position was sent to the European Commission, which endorsed it and adopted an EU-wide legally binding decision.
Danish: Da CMDh's holdning blev godkendt ved en flertalsafgørelse, blev dets standpunkt fremsendt til EuropaKommissionen, som godkendte det og vedtog en retligt bindende afgørelse for hele EU.
English: GABA decreases the excitability of many brain cells.
Danish: GABA nedsætter mange hjernecellers excitabilitet (evne til at reagere).
English: Benzodiazepines work by attaching to certain receptors in the brain, thereby increasing the activity of a substance called gamma-amino butyric acid (GABA).
Danish: Benzodiazepiner virker ved at bindes til visse receptorer i hjernen, hvor de øger aktiviteten af stoffet gammaaminosmørsyre (GABA).
English: It is taken by mouth to treat painful contractures (sustained shortening of muscle tissue), and spasticity (excessive stiffness of muscles).
Danish: Det indtages gennem munden til behandling af smertefulde kontrakturer (vedvarende forkortelse af muskelvæv) og spasticitet (unormal muskelstivhed).
English: On 24 April 2013, following the recommendation by the Pharmacovigilance Risk Assessment Committee (PRAC), the Co-ordination Group for Mutual Recognition and Decentralised ProceduresHuman (CMDh) endorsed by majority the PRAC recommendation to suspend the marketing authorisations of tetrazepam-containing medicines across the European Union (EU).
Danish: Den 24. april 2013 tilsluttede Koordinationsgruppen vedrørende gensidig anerkendelse og decentral procedure - lægemidler til mennesker (CMDh) sig ved en flertalsafgørelse anbefalingen fra Det Rådgivende Udvalg for Risikovurdering inden for Lægemiddelovervågning (PRAC) om at suspendere markedsføringstilladelserne for tetrazepamholdige lægemidler i hele EU.
English: Tetrazepam, a medicine of the benzodiazepine class, is used in several EU Member States to treat painful contractures (such as in low back pain and neck pain) and spasticity (excessive stiffness of muscles).
Danish: Tetrazepam er et lægemiddel i klassen benzodiazepiner og anvendes i en række EU-medlemsstater til behandling af smertefulde kontrakturer (såsom muskelsammentrækninger med lænderygsmerter og nakkesmerter) og spasticitet (unormal muskelstivhed).
English: • Tetrazepam is a muscle relaxant used in painful conditions such as low back pain and neck pain as well as spasticity (excessive stiffness of muscles).
Danish: • tetrazepam er et muskelafslappende middel, der anvendes ved smertefulde tilstande såsom lænderygsmerter og nakkesmerter samt ved spasticitet (unormal muskelstivhed).
English: This treatment cycle will normally be repeated every three weeks.
Danish: Denne behandlingscyklus gentages normalt hver tredje uge.
English: Date of first authorisation: 21 September 2009 Date of latest renewal: 19 June 2014
Danish: Dato for første markedsføringstilladelse : 21. september 2009 Dato for seneste fornyelse : 19. juni 2014
English: 3 Reactions have been mild and have not generally required specific therapy.
Danish: 3 Reaktionerne har været milde og har generelt ikke krævet specifik behandling.
English: Vial before opening 30 months.
Danish: Hætteglas inden åbning 30 måneder.
English: Male patients who may wish to father a child should ask their doctor for family planning advice or treatment.
Danish: Mandlige patienter, som ønsker at blive fædre, bør spørge lægen til råds om familieplanlægning eller behandling.
English: They may require hospitalisation and could even be life threatening.
Danish: De kan kræve indlæggelse på hospital og i nogle tilfælde være livstruende.
English: Volume of distribution was slightly decreased and thus half-life only increased by 14 %.
Danish: Distributionsvolumen faldt en anelse, hvorved halveringstiden kun steg 14 %.
English: Do not use Topotecan Teva if you notice any visible particles or if the solution is unclear.
Danish: Brug ikke Topotecan Teva, hvis du bemærker synlige partikler, eller hvis opløsningen er uklar.
English: Median time to progression (weeks)
Danish: Mediantid til progression (uger)
English: Very common Infection Common
Danish: Meget almindelig Infektion Almindelig
English: Very common Anorexia (which may be severe)
Danish: Meget almindelig Anoreksi (muligvis alvorlig)
English: Liquid waste may be flushed with large amounts of water.
Danish: Flydende affaldsmateriale kan skylles ud i vasken med rigelige mængder vand.
English: The carcinogenic potential of topotecan has not been studied.
Danish: Det carcinogene potentiale af topotecan er ikke undersøgt.
English: Response rate (%)
Danish: Responsrate (%)
English: The median time to response in clinical studies was 7.6-11.6 weeks.
Danish: I kliniske studier var mediantiden indtil respons 7,6-11,6 uger.
English: Frequencies are defined as: very common (≥ 1/10), common (≥ 1/100 to < 1/10);
Danish: Hyppigheden defineres som: meget almindelig (≥ 1/10), almindelig (≥ 1/100
English: Total or pronounced alopecia was observed in 30 % of patients and partial alopecia in 15 % of patients.
Danish: Total eller udtalt alopecia blev observeret hos 30 % af patienterne, og partiel alopecia hos 15 % af patienterne.
English: Very common Alopecia Common
Danish: Meget almindelig Alopeci Almindelig
English: Median survivals for the two groups were 25.0 and 24.7 weeks respectively.
Danish: Medianoverlevelsen for de to grupper var 25,0 henholdsvis 24,7 uger.
English: Topotecan also had a high volume of distribution, about 132 1 (SD 57), and a relatively short half-life of 2-3 hours.
Danish: Topotecan havde ligeledes et højt distributionsvolumen på omkring 132 l (SD 57), samt en relativ kort halveringstid på 2-3 timer.
English: Tartaric acid (E334)
Danish: Vinsyre (E334)
English: Read all of this leaflet carefully before you start using 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: Not known (frequency cannot be estimated from the available data)
Danish: Ikke kendte bivirkninger (kan ikke estimeres ud fra forhåndenværende data)
English: uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).
Danish: til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100), sjælden (≥ 1/10.000 til < 1/1.000), meget sjælden (< 1/10.000) ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: In these studies, there were no apparent differences in the pharmacokinetics of topotecan among children, adolescents, and young adult patients with solid tumours or leukaemia, but data are too limited to draw definite conclusions.
Danish: Der var i disse studier ikke nogen synlige forskelle i farmakokinetikken af topotecan hos børn, unge og yngre voksne med solide tumorer eller leukæmi, men data er for begrænsede til en definitiv konklusion.
English: Subsequent doses
Danish: Efterfølgende doser
English: Topotecan does not inhibit human P450 enzymes (see section 5.2).
Danish: Topotecan hæmmer ikke humane P450-enzymer (se pkt 5.2).
English: Keep the vial in the outer carton in order to protect from light.
Danish: Opbevar beholderen i den ydre karton for at beskytte mod lys.
English: Red cell transfusions were given in 52 % of patients (21 % of courses).
Danish: Der blev givet transfusioner af røde blodlegemer til 52 % af patienterne (21 % af serierne).
English: Interstitial lung disease (some cases have been fatal)
Danish: Interstitiel lungesygdom (nogle tilfælde har været letale)
English: As with all cytotoxic chemotherapy, patients being treated with topotecan must be advised that they or their partner must use an effective method of contraception.
Danish: Som med al cytotoksisk kemoterapi skal patienter, der behandles med topotecan, rådes til, at de eller deres partner skal anvende en effektiv kontraceptionsmetode.
English: Among all patients treated in clinical studies (including both those with severe neutropenia and those who did not develop severe neutropenia), 11 % (4 % of courses) developed fever and 26 % (9 % of courses) developed infection.
Danish: Blandt alle patienter, der blev behandlet i de kliniske studier (herunder både dem med alvorlig neutropeni og dem, der ikke udviklede alvorlig neutropeni), udviklede 11 % (4 % af serierne) feber, og 26 % (9 % af serierne) udviklede infektion.
English: IV use
Danish: IV-anvendelse
English: There is little or no accumulation of topotecan with repeated daily dosing and there is no evidence of a change in the pharmacokinetics after multiple doses.
Danish: Der ses ringe eller ingen akkumulering af topotecan efter gentagen daglig dosering, og der er ingen tegn på ændring i farmakokinetikken efter multiple doser.
English: As would be expected, patients with poor performance status (PS>1) have a lower response rate and an increased incidence of complications such as fever, infection and sepsis (see section 4.8).
Danish: Som det ville være forventet har patienter med dårlig performancestatus (PS > 1) en lavere responsrate og en øget forekomst af komplikationer såsom feber, infektion og sepsis (se pkt.
English: Metabolism accounts for <10 % of the elimination of topotecan.
Danish: Metabolisme udgør < 10 % af topotecans eliminering.
English: Of the patients who received more than 6 cycles of therapy, 91 % completed the study as planned or were treated until disease progression with only 3 % withdrawn for adverse events.
Danish: Af de patienter, som fik flere end 6 serier kemoterapi, fuldførte 91 % studiet som planlagt eller blev behandlet, indtil sygdommen progredierede, og heraf blev kun 3 % ekskluderet på grund af bivirkninger.
English: Median time to progression was similar in the two groups (13.3 weeks and 12.3 weeks respectively).
Danish: Mediantid til progression var ens i de to grupper (13,3 uger henholdsvis 12,3 uger).
English: Other severe events that were recorded as related or possibly related to topotecan treatment were anorexia (12 %), malaise (3 %) and hyperbilirubinaemia (1 %).
Danish: Andre alvorlige hændelser registreret som relateret til eller muligvis relateret til behandling med topotecan var anoreksi (12 %), utilpashed (3 %) og hyperbilirubinæmi (1 %).
English: In patients presenting with fever, neutropenia, and a compatible pattern of abdominal pain, the possibility of neutropenic colitis should be considered.
Danish: Hos patienter, som har feber, neutropeni og et kompatibelt mønster med mavesmerter, bør risikoen for neutropenisk colitis overvejes.
English: Topotecan Teva should not be used in pregnant women, unless clearly necessary.
Danish: Topotecan Teva bør ikke gives til gravide kvinder, medmindre det skønnes nødvendigt.
English: Pharmacotherapeutic group: antineoplastic agents, other antineoplastic agents, ATC code: L01XX17.
Danish: Farmakoterapeutisk klassifikation: antineoplastiske stoffer, andre antineoplastiske stoffer, ATC-kode: L01XX17.
English: The response rate in the whole ovarian carcinoma programme (n = 392, all previously treated with cisplatin or cisplatin and paclitaxel) was 16 %.
Danish: Responsraten i hele ovariecancerprogrammet (n = 392, alle tidligere behandlet med cisplatin eller cisplatin og paclitaxel) var 16 %.
English: There is no known antidote for topotecan overdose.
Danish: Der er ingen kendt antidot mod overdosis af topotecan.
English: In vitro data using human liver microsomes indicate the formation of small amounts of N-demethylated topotecan.
Danish: In vitro-data på humane levermikrosomer indikerer dannelsen af små mængder af N-demethyleret topotecan.
English: Severe neutropenia lasted beyond seven days in 11 % of courses overall.
Danish: Alvorlig neutropeni varede længere end syv dage i 11 % af alle serierne.
English: When combining topotecan with other chemotherapy agents, reduction of the doses of each medicinal product may be required to improve tolerability.
Danish: Når topotecan gives sammen med andre kemoterapeutika kan det være nødvendigt at reducere dosis af hvert af de enkelte lægemidler for at forbedre tolerancen.
English: There were no signs of cumulative haematological or non- haematological toxicity.
Danish: Der var ingen tegn på kumulativ hæmatologisk eller non-hæmatologisk toksicitet.
English: Accidental contact with the skin or eyes should be treated immediately with copious amounts of water.
Danish: • Uforvarende berøring med hud eller øjne skal omgående behandles med rigelige mængder vand.
English: Approximately 51 % was excreted as total topotecan and 3% was excreted as N-desmethyl topotecan in the urine.
Danish: Omtrent 51 % blev udskilt som uomdannet topotecan og 3 % blev udskilt som N-desmethyltopotecan i urinen.
English: In vitro, topotecan did not inhibit human P450 enzymes CYP1A2, CYP2A6, CYP2C8/9, CYP2C19, CYP2D6, CYP2E, CYP3A or CYP4A, nor did it inhibit the human cytosolic enzymes dihydropyrimidine or xanthine oxidase.
Danish: In vitro hæmmede topotecan hverken de menneskelige P450-enzymer CYP1A2, CYP2A6, CYP2C8/9, CYP2C19, CYP2D6, CYP2E, CYP3A og CYP4A eller de menneskelige cytosoliske enzymer dihydropyrimidin eller xanthinoxidase.
English: Severe bleeding (associated with thrombocytopenia)
Danish: Alvorlig blødning (associeret med trombocytopeni)
English: Frequently reported non-haematological effects were gastrointestinal, such as nausea (52 %), vomiting (32 %), diarrhoea (18 %), constipation (9 %) and mucositis (14 %).
Danish: Hyppigt rapporterede non-hæmatologiske bivirkninger var gastrointestinale, såsom kvalme (52 %), opkastning (32 %), diarré (18 %), obstipation (9 %) og mucositis (14 %).
English: An N-desmethyl metabolite, which was shown to have similar or less activity than the parent in a cell-based assay, was found in urine, plasma, and faeces.
Danish: En N-desmethylmetabolit, som i et cellebaseret assay har vist sig at have samme eller mindre aktivitet end lægemiddelstoffet, er fundet i urin, plasma og fæces.
English: Platelet transfusions were given in 4 % of courses.
Danish: Der blev givet trombocyttransfusioner i 4 % af serierne.
English: Median survival was 30.3 weeks (95 % CI: 27.6, 33.4).
Danish: Medianoverlevelsen var 30,3 uger (95 % CI: 27,6; 33,4).
English: Tumour types included were Ewing's sarcoma/primitive neuroectodermal tumour, neuroblastoma, osteoblastoma, and rhabdomyosarcoma.
Danish: Følgende tumortyper var inkluderet: Ewings sarkom/primitiv neuroektoderm tumor, neuroblastoma, osteoblastoma og rhabdomyosarcoma.
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 12 hours if stored below 25°C or 24 hours at 2-8°C, unless dilution has taken place in controlled and validated aseptic conditions.
Danish: Hvis det ikke bruges straks, er opbevaringstiderne og -betingelserne efter anbrud indtil anvendelse brugerens ansvar og vil normalt ikke være længere end 12 timer ved opbevaring under 25 °C eller 24 timer ved 2-8 °C, medmindre fortynding er sket under kontrollerede og validerede aseptiske forhold.
English: In clinical studies, topotecan was discontinued if the dose had been reduced to 1.0 mg/m2/day and a further dose reduction was required to manage adverse effects.
Danish: I kliniske studier blev topotecanbehandlingen seponeret, hvis dosis var blevet reduceret til 1,0 mg/m2/dag og yderligere reduktion af dosis var nødvendig for at håndtere bivirkninger.
English: The concentrate must be diluted before administration.
Danish: Koncentratet skal fortyndes inden indgivelse.
English: All items for administration or cleaning, including gloves, should be placed in high-risk, waste disposal bags for high-temperature incineration.
Danish: • Alt udstyr brugt til administration eller rengøring, herunder handsker, bør anbringes i en højrisiko-affaldssæk til forbrænding ved høj temperatur.
English: Preclinical studies indicate plasma protein binding of topotecan is low (35 %) and distribution between blood cells and plasma was fairly homogeneous.
Danish: Prækliniske studier tyder på, at topotecans plasmaproteinbinding er lav (35 %), og fordelingen mellem blodceller og plasma er omtrent homogen.
English: Pregnant staff should be excluded from working with this medicinal product.
Danish: - Gravide kvinder blandt personalet må ikke arbejde med dette medikament.
English: Overall recovery of topotecan-related material following five daily doses of topotecan was 71 to 76 % of the administered IV dose.
Danish: Overordnet genfinding af topotecan-relateret materiale efter fem daglige doser af topotecan var 71 til 76 % af den administrerede intravenøse dosis.
English: Intravenous use, after dilution.
Danish: Intravenøs anvendelse efter fortynding.