natgillin/translations-raw huggingface dataset:
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.
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).
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).
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).
• tetrazepam er et muskelafslappende middel, der anvendes ved smertefulde tilstande såsom lænderygsmerter og nakkesmerter samt ved spasticitet (unormal muskelstivhed).
• 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).
Denne behandlingscyklus gentages normalt hver tredje uge.
This treatment cycle will normally be repeated every three weeks.
Dato for første markedsføringstilladelse : 21. september 2009 Dato for seneste fornyelse : 19. juni 2014
Date of first authorisation: 21 September 2009 Date of latest renewal: 19 June 2014
3 Reaktionerne har været milde og har generelt ikke krævet specifik behandling.
3 Reactions have been mild and have not generally required specific therapy.
Hætteglas inden åbning 30 måneder.
Vial before opening 30 months.
Mandlige patienter, som ønsker at blive fædre, bør spørge lægen til råds om familieplanlægning eller behandling.
Male patients who may wish to father a child should ask their doctor for family planning advice or treatment.
De kan kræve indlæggelse på hospital og i nogle tilfælde være livstruende.
They may require hospitalisation and could even be life threatening.
Distributionsvolumen faldt en anelse, hvorved halveringstiden kun steg 14 %.
Volume of distribution was slightly decreased and thus half-life only increased by 14 %.
Brug ikke Topotecan Teva, hvis du bemærker synlige partikler, eller hvis opløsningen er uklar.
Do not use Topotecan Teva if you notice any visible particles or if the solution is unclear.
Mediantid til progression (uger)
Median time to progression (weeks)
Meget almindelig Infektion Almindelig
Very common Infection Common
Meget almindelig Anoreksi (muligvis alvorlig)
Very common Anorexia (which may be severe)
Flydende affaldsmateriale kan skylles ud i vasken med rigelige mængder vand.
Liquid waste may be flushed with large amounts of water.
Det carcinogene potentiale af topotecan er ikke undersøgt.
The carcinogenic potential of topotecan has not been studied.
Responsrate (%)
Response rate (%)
I kliniske studier var mediantiden indtil respons 7,6-11,6 uger.
The median time to response in clinical studies was 7.6-11.6 weeks.
Hyppigheden defineres som: meget almindelig (≥ 1/10), almindelig (≥ 1/100
Frequencies are defined as: very common (≥ 1/10), common (≥ 1/100 to < 1/10);
Total eller udtalt alopecia blev observeret hos 30 % af patienterne, og partiel alopecia hos 15 % af patienterne.
Total or pronounced alopecia was observed in 30 % of patients and partial alopecia in 15 % of patients.
Meget almindelig Alopeci Almindelig
Very common Alopecia Common
Medianoverlevelsen for de to grupper var 25,0 henholdsvis 24,7 uger.
Median survivals for the two groups were 25.0 and 24.7 weeks respectively.
Topotecan havde ligeledes et højt distributionsvolumen på omkring 132 l (SD 57), samt en relativ kort halveringstid på 2-3 timer.
Topotecan also had a high volume of distribution, about 132 1 (SD 57), and a relatively short half-life of 2-3 hours.
Vinsyre (E334)
Tartaric acid (E334)
Læs denne indlægsseddel grundigt inden du begynder at få dette lægemiddel, da den indeholder vigtige oplysninger.
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Ikke kendte bivirkninger (kan ikke estimeres ud fra forhåndenværende data)
Not known (frequency cannot be estimated from the available data)
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).
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).
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.
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.
Efterfølgende doser
Subsequent doses
Topotecan hæmmer ikke humane P450-enzymer (se pkt 5.2).
Topotecan does not inhibit human P450 enzymes (see section 5.2).
Opbevar beholderen i den ydre karton for at beskytte mod lys.
Keep the vial in the outer carton in order to protect from light.
Der blev givet transfusioner af røde blodlegemer til 52 % af patienterne (21 % af serierne).
Red cell transfusions were given in 52 % of patients (21 % of courses).
Interstitiel lungesygdom (nogle tilfælde har været letale)
Interstitial lung disease (some cases have been fatal)
Som med al cytotoksisk kemoterapi skal patienter, der behandles med topotecan, rådes til, at de eller deres partner skal anvende en effektiv kontraceptionsmetode.
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.
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.
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.
IV-anvendelse
IV use
Der ses ringe eller ingen akkumulering af topotecan efter gentagen daglig dosering, og der er ingen tegn på ændring i farmakokinetikken efter multiple doser.
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.
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.
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).
Metabolisme udgør < 10 % af topotecans eliminering.
Metabolism accounts for <10 % of the elimination of topotecan.
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.
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.
Mediantid til progression var ens i de to grupper (13,3 uger henholdsvis 12,3 uger).
Median time to progression was similar in the two groups (13.3 weeks and 12.3 weeks respectively).
Andre alvorlige hændelser registreret som relateret til eller muligvis relateret til behandling med topotecan var anoreksi (12 %), utilpashed (3 %) og hyperbilirubinæmi (1 %).
Other severe events that were recorded as related or possibly related to topotecan treatment were anorexia (12 %), malaise (3 %) and hyperbilirubinaemia (1 %).
Hos patienter, som har feber, neutropeni og et kompatibelt mønster med mavesmerter, bør risikoen for neutropenisk colitis overvejes.
In patients presenting with fever, neutropenia, and a compatible pattern of abdominal pain, the possibility of neutropenic colitis should be considered.
Topotecan Teva bør ikke gives til gravide kvinder, medmindre det skønnes nødvendigt.
Topotecan Teva should not be used in pregnant women, unless clearly necessary.
Farmakoterapeutisk klassifikation: antineoplastiske stoffer, andre antineoplastiske stoffer, ATC-kode: L01XX17.
Pharmacotherapeutic group: antineoplastic agents, other antineoplastic agents, ATC code: L01XX17.
Responsraten i hele ovariecancerprogrammet (n = 392, alle tidligere behandlet med cisplatin eller cisplatin og paclitaxel) var 16 %.
The response rate in the whole ovarian carcinoma programme (n = 392, all previously treated with cisplatin or cisplatin and paclitaxel) was 16 %.
Der er ingen kendt antidot mod overdosis af topotecan.
There is no known antidote for topotecan overdose.
In vitro-data på humane levermikrosomer indikerer dannelsen af små mængder af N-demethyleret topotecan.
In vitro data using human liver microsomes indicate the formation of small amounts of N-demethylated topotecan.
Alvorlig neutropeni varede længere end syv dage i 11 % af alle serierne.
Severe neutropenia lasted beyond seven days in 11 % of courses overall.
Når topotecan gives sammen med andre kemoterapeutika kan det være nødvendigt at reducere dosis af hvert af de enkelte lægemidler for at forbedre tolerancen.
When combining topotecan with other chemotherapy agents, reduction of the doses of each medicinal product may be required to improve tolerability.
Der var ingen tegn på kumulativ hæmatologisk eller non-hæmatologisk toksicitet.
There were no signs of cumulative haematological or non- haematological toxicity.
• Uforvarende berøring med hud eller øjne skal omgående behandles med rigelige mængder vand.
Accidental contact with the skin or eyes should be treated immediately with copious amounts of water.
Omtrent 51 % blev udskilt som uomdannet topotecan og 3 % blev udskilt som N-desmethyltopotecan i urinen.
Approximately 51 % was excreted as total topotecan and 3% was excreted as N-desmethyl topotecan in the urine.
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.
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.
Alvorlig blødning (associeret med trombocytopeni)
Severe bleeding (associated with thrombocytopenia)
Hyppigt rapporterede non-hæmatologiske bivirkninger var gastrointestinale, såsom kvalme (52 %), opkastning (32 %), diarré (18 %), obstipation (9 %) og mucositis (14 %).
Frequently reported non-haematological effects were gastrointestinal, such as nausea (52 %), vomiting (32 %), diarrhoea (18 %), constipation (9 %) and mucositis (14 %).
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.
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.
Der blev givet trombocyttransfusioner i 4 % af serierne.
Platelet transfusions were given in 4 % of courses.
Medianoverlevelsen var 30,3 uger (95 % CI: 27,6; 33,4).
Median survival was 30.3 weeks (95 % CI: 27.6, 33.4).
Følgende tumortyper var inkluderet: Ewings sarkom/primitiv neuroektoderm tumor, neuroblastoma, osteoblastoma og rhabdomyosarcoma.
Tumour types included were Ewing's sarcoma/primitive neuroectodermal tumour, neuroblastoma, osteoblastoma, and rhabdomyosarcoma.
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.
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.
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.
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.
Koncentratet skal fortyndes inden indgivelse.
The concentrate must be diluted before administration.
• Alt udstyr brugt til administration eller rengøring, herunder handsker, bør anbringes i en højrisiko-affaldssæk til forbrænding ved høj temperatur.
All items for administration or cleaning, including gloves, should be placed in high-risk, waste disposal bags for high-temperature incineration.
Prækliniske studier tyder på, at topotecans plasmaproteinbinding er lav (35 %), og fordelingen mellem blodceller og plasma er omtrent homogen.
Preclinical studies indicate plasma protein binding of topotecan is low (35 %) and distribution between blood cells and plasma was fairly homogeneous.
- Gravide kvinder blandt personalet må ikke arbejde med dette medikament.
Pregnant staff should be excluded from working with this medicinal product.
Overordnet genfinding af topotecan-relateret materiale efter fem daglige doser af topotecan var 71 til 76 % af den administrerede intravenøse dosis.
Overall recovery of topotecan-related material following five daily doses of topotecan was 71 to 76 % of the administered IV dose.
Intravenøs anvendelse efter fortynding.
Intravenous use, after dilution.
Lette abdominalsmerter blev rapporteret hos 4 % patienterne.
Mild abdominal pain was reported in 4 % of patients.
I en population af patienter med refraktær SCLC (dem som ikke responderer på 1. linje-behandling) var responsraten 4,0 %.
In a population of patients with refractory SCLC (those not responding to first line therapy), the response rate to topotecan was 4.0 %.
Fæcal eliminering af uomdannet topotecan udgjorde 18 % mens fæcal eliminering af N-desmethyltopotecan var 1,7 %.
Faecal elimination of total topotecan accounted for 18% while faecal elimination of N-desmethyl topotecan was 1.7 %.
Denne indlægsseddel blev senest ændret MM/YYYY
This leaflet was last revised in MM/YYYY.
Forsigtighed bør dog udvises ved kørsel med motorkøretøj og ved betjening af maskiner, hvis træthed og asteni vedvarer.
However, caution should be observed when driving or operating machines if fatigue and asthenia persist.
Et fase II-studie (studie 065) og et fase III-studie (studie 396) blev gennemført til vurdering af virkningen af oral topotecan versus intravenøs topotecan til patienter, der havde oplevet tilbagefald ≥ 90 dage efter afslutningen af et tidligere behandlingsforløb med kemoterapi (se tabel 1).
One Phase II study (Study 065) and one Phase III study (Study 396) were conducted to evaluate the efficacy of oral topotecan versus intravenous topotecan in patients who had relapsed ≥ 90 days after completion of one prior regimen of chemotherapy (see Table 1).
Hos patienter, der var refraktære eller som fik tilbagefald inden for 3 måneder efter cisplatinbehandling (n = 186), var responsraten 10 %.
In patients refractory to, or relapsing within 3 months after cisplatin therapy (n = 186), the response rate was 10%.
Topotecan er dog som andre cytostatika genotoksisk, og påvirkning af fertiliteten, herunder den mandlige fertilitet, kan ikke udelukkes.
However as with other cytotoxic medicinal products topotecan is genotoxic and effects on fertility, including male fertility, cannot be excluded.
• Personale, som håndterer dette lægemiddel under fortynding, skal bære beskyttelsesdragt herunder maske, briller og handsker.
Personnel handling this medicinal product during dilution should wear protective clothing including mask, goggles and gloves.
I kliniske studier er udslæt rapporteret hos 4 % af patienterne og pruritus hos 1,5 % af patienterne.
In clinical studies, rash was reported in 4 % of patients and pruritus in 1.5 % of patients.
Da der er begrænset erfaring med behandling af børn, kan dette ikke anbefales.
The experience in children is limited and treatment is therefore not recommended.
Hvis enten cisplatin eller carboplatin gives på dag 1 for topotecan-doseringen, skal der gives en lavere dosis af begge stoffer for at forbedre tolerancen sammenlignet med den dosis af de enkelte stoffer, der kan gives, hvis platin-stofferne, hvis de gives på dag 5 for topotecandoseringen.
If either cisplatin or carboplatin is given on day 1 of the topotecan dosing, a lower dose of each agent must be given to improve tolerability compared to the dose of each agent which can be given if the platinum agent is given on day 5 of the topotecan dosing.
Hyppigheden af alvorlig (grad 3 eller 4) kvalme, opkastning, diarré og mucositis var henholdsvis 4, 3, 2 og 1 %.
The incidence of severe (Grade 3 or 4) nausea, vomiting, diarrhoea and mucositis was 4, 3, 2 and 1 % respectively.
Nedenstående oplysninger er til læger og sundhedspersonale: Instruktion i fortynding, opbevaring og bortskaffelse af Topotecan Teva Anvisninger for fortynding
The following information is intended for healthcare professionals only: Instructions on how to dilute, store and dispose of Topotecan Teva Instructions for dilution
Overdosering er blevet rapporteret hos patienter i behandling med intravenøs topotecan (op til 10 gange den anbefalede dosis) og topotacan kaspler (op til 5 gange den anbefalede dosis).
Overdoses have been reported in patients being treated with intravenous topotecan (up to 10 fold of the recommended dose) and topotecan capsules (up to 5 fold of the recommended dose).
I oral topotecan plus BSC-gruppen var der en statistisk signifikant forbedring i samlet overlevelse sammenlignet med gruppen med BSC alene (log-rank p = 0,0104).
In the oral topotecan plus BSC group there was a statistically significant improvement in overall survival compared with the BSC alone group (Log- rank p = 0.0104).
De normale procedurer for omgang med anticancer medicin skal følges:
The normal procedures for proper handling and disposal of anticancer medicinal products should be adopted:
Topotecan-O-glukuronid og N-desmethyltopotecan-O-glukuronid i urinen var mindre end 2,0 %.
The topotecan-O-glucuronide andN-desmethyl topotecan-O-glucuronide in the urine were less than 2.0%.
Endvidere udviklede 5 % (1 % af serierne) af alle de behandlede patienter sepsis (se pkt.
In addition, 5 % of all patients treated (1 % of courses) developed sepsis (see section 4.4).
Oversigt over overlevelse, responsrate og tid til progression hos SCLC-patienter, der er behandlet med oral eller intravenøs topotecan Studie 065
Summary of survival, response rate, and time to progression in SCLC patients treated with oral or intravenous topotecan
I forbindelse med alvorlig neutropeni forekom feber eller infektion hos 16 % af patienterne under serie 1 og totalt set hos 23 % af patienterne (6 % af serierne).
In association with severe neutropenia, fever or infection occurred in 16 % of patients during course 1 and overall in 23 % of patients (6 % of courses).
patienter med recidiverende småcellet lungecancer (SCLC) for hvem gentagelse af 1. linjebehandling ikke anses for hensigtsmæssig (se pkt.
patients with relapsed small cell lung cancer (SCLC) for whom re-treatment with the first-line regimen is not considered appropriate (see section 5.1).
N = antal behandlede patienter CI = konfidensinterval
N = total number of patients treated.
Inden for hver enkelt hyppighedsgruppe skal bivirkningerne opstillet efter, hvor alvorlige de er.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
CYTOTOKSISK, særlige håndteringsinstruktioner (se indlægssedlen).
CYTOTOXIC, special handling instructions (see package leaflet).
Fortæl det altid til lægen, hvis du bruger anden medicin eller har brugt det for nylig.
Tell your doctor if you are taking, have recently taken or might take any other medicines.
En O-glukuroniseret metabolit af topotecan og Ndesmethyltopotecan er identificeret i urin.
An O-glucuronidation metabolite of topotecan and Ndesmethyl topotecan has been identified in the urine.
Yderligere oplysninger om dette lægemiddel findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/.
Detailed information on this medicine is available on the website of the European Medicines Agency (EMA) http://www.ema.europa.eu/.
Topotecan skal fortyndes yderligere inden anvendelse (se pkt.
Topotecan must be further diluted before use (see section 6.6).
Hos patienter med moderat nedsat nyrefunktion faldt topotecan plasmaclearance til 34 % af værdien for kontrolgruppens patienter.
In patients with moderate renal impairment topotecan plasma clearance was reduced to 34 % of the value in control patients.
Disse data bør evalueres i lyset af den totale sikkerhedsprofil af lægemidlet, specielt den signifikante hæmatologiske toksicitet.
These data should be evaluated in the context of the overall safety profile of the medicinal product, in particular of the significant haematological toxicity (see section 4.8).
Kontakt straks din læge, hvis du får nogle af nedenstående alvorlige symptomer.
You must tell your doctor immediately if you experience any of the following serious side effects.
Kvinder i den fødedygtige alder skal bruge en effektiv præventionsmetode, for at undgå at blive gravid under behandlingen.
Women of child-bearing potential should use effective contraception to avoid becoming pregnant while on treatment.
Meget almindelig Pyreksi, asteni, træthed Almindelig
Very common Pyrexia, asthenia, fatigue Common
I studier til dosisbestemmelses omfattende 523 patienter med recidiverende ovariecancer og 631 patienter med recidiverende småcellet lungecancer var den dosisbegrænsende toksicitet af topotecanmonoterapi hæmatologisk.
In dose-finding studies involving 523 patients with relapsed ovarian cancer and 631 patients with relapsed small cell lung cancer, the dose limiting toxicity of topotecan monotherapy was found to be haematological.
2 Neutropenisk colitis, herunder letal neutropenisk colitis, er set som en komplikation til topotecan induceret neutropeni (se pkt.
2 Neutropenic colitis, including fatal neutropenic colitis, has been reported to occur as a complication of topotecan-induced neutropenia (see section 4.4).
Træthed blev observeret hos ca. 25 % og asteni hos 16 % af patienterne, som blev behandlet med topotecan.
Fatigue was observed in approximately 25 % and asthenia in 16 % of patients receiving topotecan.
Medianoverlevelse (uger)
Median survival (weeks)
Dette bør overvejes, når Topotecan Teva ordineres, f.eks i tilfælde, hvor det overvejes at behandle patienter med øget risiko for tumorblødning.
This should be taken into account when prescribing Topotecan Teva, e.g. if patients at increased risk of tumour bleeds are considered for therapy.