FrancophonIA/ELRC3.0 huggingface dataset:
English: Package leaflet: Information for the patient Kengrexal 50 mg powder for concentrate for solution for injection/infusion cangrelor
Danish: Indlægsseddel: Information til patienten Kengrexal 50 mg pulver til koncentrat til injektions-/infusionsvæske, opløsning.
English: Very rare side effects: may affect up to 1 in 10,000 people
Danish: Meget sjældne bivirkninger: kan forekomme hos op til 1 ud af 10.000 personer
English: Treatment with Kengrexal may increase the risk of bleeding.
Danish: Behandling med Kengrexal kan øge blødningsrisikoen.
English: Erythema, rash erythematous, rash pruritic.
Danish: Erytem, erytematøst udslæt, pruritisk udslæt.
English: • rash, pruritus, urticaria,
Danish: Hududslæt, pruritus, urticariaf
English: The vial should be reconsituted immediately prior to dilution and use.
Danish: Hætteglasset skal rekonstitueres straks inden fortynding og anvendelse.
English: Following the administration of a 30 microgram/kg bolus followed by a 4 microgram/kg/min infusion, platelet inhibition is observed within two minutes.
Danish: Efter administration af en 30 mikrogram/kg bolus efterfulgt af en 4 mikrogram/kg/min.
English: Menorrhagia, penile haemorrhage
Danish: Menorrhagi, blødning i penis
English: After reconstitution 1 mL of concentrate contains 10 mg cangrelor.
Danish: Efter rekonstitution indeholder 1 ml koncentrat 10 mg cangrelor.
English: After dilution 1 mL contains 200 micrograms cangrelor.
Danish: Efter fortynding indeholder 1 ml opløsning 200 mikrogram cangrelor.
English: Primary Endpoint
Danish: Primært endepunkt
English: Rare side effects: may affect up to 1 in 1,000 people
Danish: Sjældne bivirkninger: kan forekomme hos op til 1 ud af 1.000 personer
English: Treatment with Kengrexal may increase the risk of cardiac tamponade.
Danish: Behandling med Kengrexal kan øge risikoen for hjertetamponade.
English: MARKETING AUTHORISATION HOLDER
Danish: Indehaver af markedsføringstilladelsen
English: After reconstitution 1 mL contains 10 mg cangrelor.
Danish: Efter rekonstitution indeholder 1 ml opløsning 10 mg cangrelor.
English: Kengrexal 50 mg powder for concentrate for solution for injection/infusion cangrelor
Danish: Kengrexal 50 mg pulver til koncentrat til injektions-/infusionsvæske, opløsning cangrelor
English: Treatment with Kengrexal may increase the risk of intracranial haemorrhage.
Danish: Behandling med Kengrexal kan øge risikoen for intrakraniel blødning.
English: Uncommon side effects: may affect up to 1 in 100 people
Danish: Ikke almindelige bivirkninger: kan forekomme hos op til 1 ud af 100 personer
English: Common side effects: may affect up to 1 in 10 people
Danish: Almindelige bivirkninger: kan forekomme hos op til 1 ud af 10 personer
English: Powder for concentrate for solution for injection/infusion 10 vials
Danish: Pulver til koncentrat til injektions-/infusionsvæske, opløsning 10 hætteglas.
English: Kengrexal 50 mg powder for concentrate for solution for injection/infusion
Danish: Kengrexal 50 mg pulver til koncentrat til injektions-/infusionsvæske, opløsning
English: Chiesi Farmaceutici S.p.A. Τηλ: + 39 0521 2791
Danish: Τηλ: + 39 0521 2791
English: • bruising,
Danish: * Inkl.
English: In patients with severe renal impairment (creatinine clearance 15-30 mL/min) a higher rate of worsening in renal function (3.2%) was reported in the cangrelor group compared to clopidogrel (1.4%).
Danish: blev der rapporteret en højere forekomst af forværringer i nyrefunktion (3,2 %) i cangrelorgruppen end i clopidogrelgruppen (1,4 %).
English: Platelet count decreased, red blood cell count decreased, international normalised ratio increased c
Danish: Nedsat trombocyttal, nedsat erytrocyttal, forhøjet INRc
English: gastrointestinal tract, in the abdomen, or in the urine or from injection or catheter sites,
Danish: Blødning på applikationsstedet, blødning eller hæmatom på kateterstedet, blødning eller hæmatom på infusionsstedet.
English: Stent thrombosis
Danish: Stenttrombose
English: Pelvic haemorrhage
Danish: Nyrer og urinveje
English: Skin neoplasm bleeding
Danish: Næseblod, hæmoptyse
English: Chiesi Farmaceutici S.p.A. Tel: + 39 0521 2791
Danish: Tel: + 39 0521 2791
English: Clopidogrel N=5,469 OR (95% CI)
Danish: Clopidogrel N=5.469
English: Cardiac disorders
Danish: Hjertetamponade
English: Haemodynamic instability
Danish: Hæmodynamisk ustabilitet
English: Common
Danish: Hjerte
English: Haematocrit decreased, haemoglobin decreased**
Danish: Nedsat hæmatokrit, nedsat hæmoglobin
English: Haematoma infection
Danish: intravenøs infusion.
English: Clopidogrel N=5,457 OR (95% CI)
Danish: Clopidogrel N=5.457
English: The European Commission issued a decision on this opinion on 26/6/17.
Danish: Europa-Kommissionen traf en afgørelse om denne udtalelse den 26/6/17.
English: Vepesid is authorised in the EU via national procedures.
Danish: Vepesid er godkendt i EU via nationale procedurer.
English: The amended information to doctors and patients is available here.
Danish: Den ændrede produktinformation til læger og patienter findes her.
English: What is Vepesid?
Danish: Hvad er Vepesid?
English: Vepesid is marketed in 16 EU member States (Austria, Belgium, Croatia, Denmark, Estonia, Finland, Germany, Ireland, Italy, Luxembourg, the Netherlands, Romania, Slovenia, Spain, Sweden and the United Kingdom) as well as in Norway.
Danish: Vepesid markedsføres i 16 EU-medlemsstater (Østrig, Belgien, Kroatien, Danmark, Estland, Finland, Tyskland, Irland, Italien, Luxembourg, Nederlandene, Rumænien, Slovenien, Spanien, Sverige og Det Forenede Kongerige) samt Norge.
English: On 21 April 2017, the European Medicines Agency completed a review of Vepesid.
Danish: Den 21. april 2017 afsluttede Det Europæiske Lægemiddelagentur en gennemgang af Vepesid.
English: What are the conclusions of the CHMP?
Danish: Hvilke konklusioner drog CHMP?
English: Why was Vepesid reviewed?
Danish: Hvorfor blev Vepesid vurderet igen?
English: The areas of the SmPC harmonised include:
Danish: De harmoniserede områder af produktresuméet er følgende:
English: The usual dose of Vepesid is 100 to 200 mg per m2 of body surface area for 5 days in a row or 200 mg/m2/day on days 1, 3 and 5 every 3 to 4 weeks.
Danish: Den sædvanlige dosis af Vepesid er 100-200 mg pr. m2 legemsoverflade i 5 på hinanden følgende dage, eller 200 mg/m2/dag på dag 1, 3 og 5 hver 3. til 4. uge.
English: • small-cell lung cancer;
Danish: • småcellet lungekræft
English: It is also available in the EU under the trade name Vepesid K. The company that markets these medicines is Bristol-Myers Squibb.
Danish: Vepesid fås desuden i EU under handelsnavnet Vepesid K. Den virksomhed, der markedsfører disse lægemidler, er Bristol-Myers Squibb.
English: Vepesid capsules should be taken on an empty stomach.
Danish: Vepesid-kapsler skal tages på tom mave.
English: This has led to divergences across Member States in the way the medicine can be used, as seen in the differences in the summaries of product characteristics (SmPCs), labelling and package leaflets in the countries where the medicine is marketed.
Danish: Dette har ført til afvigelser mellem medlemsstaterne i den måde, lægemidlet kan anvendes på, som det ses af forskellene mellem produktresuméerne, etiketteringen og indlægssedlerne i de lande, hvor lægemidlet markedsføres.
English: On 14 October 2015, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Vepesid in the EU.
Danish: Den 14. oktober 2015 indbragte Europa-Kommissionen sagen for CHMP med henblik på harmonisering af markedsføringstilladelserne for Vepesid i EU.
English: The CHMP recommended that Vepesid should be used in combination with other cancer treatments to treat the following cancers in adults:
Danish: CHMP anbefalede, at Vepesid anvendes i kombination med andre kræftmidler til behandling af følgende kræftformer hos voksne:
English: Other sections of the SmPC harmonised include section 4.4 (special warnings and precautions), section 4.6 (fertility, pregnancy and lactation) and section 4.8 (undesirable effects).
Danish: CHMP harmoniserede derudover andre punkter i produktresuméet, herunder punkt 4.4 (særlige advarsler og forsigtighedsregler vedrørende brugen), 4.6 (fertilitet, graviditet og amning) og 4.8 (bivirkninger).
English: Vepesid is a cancer medicine used to treat: testicular cancer, lung cancer, ovarian cancer and cancers of the blood (Hodgkin's and non-Hodgkin's lymphoma and acute myeloid leukaemia).
Danish: Vepesid er et kræftlægemiddel til behandling af testikelkræft, lungekræft, ovariecancer og blodkræft (Hodgkins og ikke-Hodgkins lymfom og akut myeloid leukæmi).
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that there is a need to harmonise the prescribing information for Vepesid in the European Union (EU).
Danish: Agenturets udvalg for lægemidler til mennesker (CHMP) konkluderede, at der er behov for harmonisering af produktinformationen for Vepesid i Den Europæiske Union (EU).
English: Vepesid contains the active substance etoposide and is available as capsules to be taken by mouth.
Danish: Vepesid indeholder det aktive stof etoposid og fås som kapsler til indtagelse gennem munden.
English: • non-epithelial ovarian cancer.
Danish: • ikke-epitelial ovariecancer
English: The dose of Vepesid is based on the recommended dose for the intravenous etoposide medicines, with a 100 mg oral dose being comparable to a 75 mg intravenous one.
Danish: Dosis af Vepesid er baseret på den anbefalede dosis til intravenøse lægemidler med etoposid, idet en 100 mg dosis taget gennem munden svarer til 75 mg indgivet intravenøst.
English: • Hodgkin's lymphoma as second-line treatment;
Danish: • Hodgkins lymfom, som andetvalgsbehandling
English: Vepesid should not be taken at the same time as vaccination with yellow fever or other live vaccines in patients with weakened immune systems and should not be taken by breast-feeding women.
Danish: Hos patienter med svækket immunsystem bør Vepesid ikke tages samtidig med en vaccine mod gul feber eller andre levende vacciner, og det bør ikke tages af ammende kvinder.
English: In addition, the CHMP recommended Vepesid for treating epithelial ovarian cancer that is resistant to treatments with platinum-containing medicines, with no specification that it should be used in combination with other medicines.
Danish: CHMP anbefalede derudover Vepesid til behandling af epitelial ovariecancer, som platinholdige lægemidler ikke virker på, uden angivelse af, om det skal anvendes i kombination med andre lægemidler.
English: • testicular cancer that is resistant to treatment or has come back;
Danish: • testikelkræft, som behandling ikke virker på, eller som er vendt tilbage
English: • acute myeloid leukaemia that is resistant to treatment or has come back;
Danish: • akut myeloid leukæmi, som behandling ikke har virket på, eller som er vendt tilbage
English: • non-Hodgkin's lymphoma that is resistant to treatment or has come back;
Danish: • ikke-Hodgkins lymfom, som behandling ikke har virket på, eller som er vendt tilbage
English: The CHMP, in the light of the data submitted and the scientific discussion within the Committee, was of the opinion that the SmPCs and package leaflets should be harmonised across the EU.
Danish: CHMP fandt det nødvendigt at harmonisere produktresuméer og indlægssedler i EU på baggrund af de forelagte oplysninger og den videnskabelige drøftelse i udvalget.
English: Vepesid was identified as needing harmonisation by the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh).
Danish: CMD(h) (Koordinationsgruppen vedrørende gensidig anerkendelse og decentrale procedurerlægemidler til mennesker) fandt det nødvendigt at harmonisere for Vepesid.
English: EMA/251790/2017 Rev. 1
Danish: Spørgsmål og svar om Vepesid og relaterede navne (etoposid, kapsler, 50 og 100 mg) EMA/251790/2017 Rev. 1
English: This is called a ‘remission'.
Danish: Dette kaldes en 'remission'.
English: How much to take
Danish: Hvor meget du skal tage
English: 5 years
Danish: 5 år
English: It works in a number of different ways:
Danish: Det virker på flere forskellige måder:
English: These measures will prevent misuse.
Danish: Disse forholdsregler forebygger misbrug.
English: • The patient has acknowledged the aforementioned conditions.
Danish: • Patienten har accepteret de førnævnte betingelser.
English: * WHO Criteria
Danish: * WHO-kriterier
English: Key elements to be included
Danish: Nøgleelementer, der skal inkluderes
English: Not known (frequency cannot be estimated from the available data) :
Danish: Ikke kendt (hyppigheden kan ikke estimeres ud fra forhåndenværende data):
English: The risk increased over time and was about 2 % after two years and about 4 % after three years.
Danish: Risikoen øgedes med tiden og var ca. 2 % efter to år og ca. 4 % efter tre år.
English: Take your next capsules at the usual time the next day.
Danish: Tag dine næste kapsler til sædvanlig tid næste dag.
English: AND ≥ 100,000
Danish: OG ≥ 100.000
English: This may mean that you are more likely to develop infections.
Danish: Dette kan betyde, at du er mere udsat for at udvikle infektioner.
English: • Having difficulty in seeing or speaking, which is temporary.
Danish: • Svært ved at se eller tale, hvilket er forbigående.
English: • you have experienced sleepiness.
Danish: • Du har oplevet søvnighed.
English: Figure 1: Overall survival according to treatment
Danish: Figur 1: Samlet overlevelse i henhold til behandling
English: This belongs to a group of medicines which affect how your immune system works.
Danish: Det tilhører en gruppe lægemidler, der påvirker den måde, dit immunsystem virker på.
English: Read it carefully and follow the related instructions.
Danish: Læs informationen omhyggeligt og følg de tilhørende instruktioner.
English: A national controlled distribution system has been implemented in collaboration with each National Competent Authority.
Danish: Der er implementeret et nationalt kontrolleret distributionssystem i samarbejde med hver nationale, kompetente myndighed.
English: Survival time median ± se (month)
Danish: Overlevelsestid median ± se (måned)
English: Grades 3 and 4*
Danish: Grad 3 og 4*
English: • Swallow the capsules whole with a full glass of water.
Danish: • Synk kapslerne hele med et helt glas vand.
English: It has no antibacterial effects.
Danish: Det har ingen antibakterielle virkninger.
English: The risk appears to be greatest during the first 5 months of therapy.
Danish: Risikoen synes at være størst i de første 5 måneder af behandlingen.
English: • Take this medicine by mouth.
Danish: • Dette lægemiddel indtages via munden.
English: However, the signs and symptoms can be greatly reduced or disappear for a period of time.
Danish: Tegn og symptomer kan imidlertid reduceres kraftigt eller forsvinde i en periode.
English: Date of first authorisation: 16 April 2008 Date of latest renewal: 08 February 2018
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN Dato for første markedsføringstilladelse: 16. april 2008 Dato for seneste fornyelse: 08 februar 2018
English: • Post-marketing and compliance assessment (as applicable to a Member State)
Danish: • Post-markedsførings- og kompliansvurdering (som relevant i den pågældende medlemsstat)
English: Your doctor should check whether you have ever had hepatitis B infection.
Danish: Lægen skal undersøge, om du nogensinde har haft hepatitis B-infektion.
English: Other less frequent abnormalities have also been described.
Danish: Andre mindre hyppige misdannelser er også beskrevet.
English: It may become very severe, painful and disabling.
Danish: Det kan blive meget alvorligt, smertefuldt og invaliderende.
English: Keep the package intact.
Danish: Bevar emballagen intakt.
English: A maximum number of 12 cycles of 6 weeks (42 days) should be used.
Danish: Der bør anvendes højst 12 cyklusser af 6 ugers (42 dages) varighed.
English: • Take the capsules as a single dose before going to bed.
Danish: • Tag kapslerne som en enkelt dosis, før du går i seng.
English: This applies even if the man has had a vasectomy.
Danish: Dette gælder, selv hvis manden er vasektomeret.
English: If you are able to become pregnant:
Danish: Hvis du kan blive gravid:
English: The following side effects may happen with this medicine:
Danish: Følgende bivirkninger kan forekomme med denne medicin:
English: However, reports following relatively shortterm use also exist.
Danish: Imidlertid er det også rapporteret efter relativt korte anvendelsesperioder.
English: Absorption of thalidomide is slow after oral administration.
Danish: Absorptionen af thalidomid er langsom efter oral administration.
English: However, dose reduction is not necessarily followed by improvement of symptoms.
Danish: Dosisreduktion efterfølges dog ikke nødvendigvis af en bedring af symptomerne.
English: Consider reducing dose if symptoms worsen.
Danish: Overvej at nedsætte dosis, hvis symptomerne forværres.
English: In a phase 3 study, the median time to first neuropathy event was 42.3 weeks.
Danish: I et fase 3-studie var mediantiden til den første neuropatiske hændelse 42,3 uger.
English: • The most appropriate strategies to monitor the off-label use within national territories
Danish: • De mest hensigtmæssige strategier til at monitorere off-label-brug inden for nationale grænser
English: Total systemic exposure (AUC) is proportional to dose at single-dose conditions.
Danish: Den totale systemiske eksponering (AUC) er proportional med dosis ved enkeltdosis-betingelser.
English: The relevance to humans is unknown.
Danish: Betydningen for mennesker er ukendt.
English: • Swelling of hands and feet.
Danish: • Hævelse af hænder og fødder.
English: Further to the per protocol analysis, an update was conducted for the IFM 99-06 study providing an additional 15 months follow-up data.
Danish: Ud over per protokol-analysen blev der foretaget en opdatering af IFM 99-06-studiet, som leverede yderligere 15 måneders opfølgningsdata.
English: MP - T
Danish: MP MP - T
English: • Periodic Safety Update Reports (PSUR)
Danish: • Periodiske, opdaterede sikkerhedsindberetninger (PSUR'er)
English: This side effect usually happens after you have been taking this medicine for several months but can happen sooner than this.
Danish: Denne bivirkning forekommer sædvanligvis efter, at du har taget medicinen i flere måneder, men den kan også forekomme tidligere.
English: However, patients with age > 75 years are potentially at risk for a higher frequency of serious adverse reactions.
Danish: Patienter > 75 år har imidlertid en mulig risiko for en øget hyppighed af alvorlige bivirkninger.
English: It is not a contract and does not absolve anybody from his/her responsibilities with regard to the safe use of the product and prevention of foetal exposure.”
Danish: Det er ikke en kontrakt og frikender ikke nogen for deres ansvar mht. sikker anvendelse af produktet og forebyggelse af føtal eksponering.
English: This will make you less likely to feel sleepy at other times.
Danish: Dette vil forhindre, at du føler dig døsig på andre tidspunkter.
English: The plasma protein binding of the (+)-(R) and (-)-(S) enantiomers was found to be 55 % and 65 % respectively.
Danish: Plasmaproteinbindingen af (+)-(R) og (-)-(S) enantiomerer blev påvist at være henholdsvis 55 % og 65 %.
English: The majority of the radioactive dose was excreted within 48 hour following dose administration.
Danish: Hovedparten af den radioaktive dosis blev udskilt inden for 48 timer efter indgivelse.
English: • are associated with neuropathy such as other treatments for cancer.
Danish: • Er forbundet med neuropati, såsom anden behandling mod kræft.
English: The conditions of the Pregnancy Prevention Programme must be fulfilled for all male and female patients.
Danish: Betingelserne i svangerskabsforebyggelsesprogrammet skal opfyldes af alle mandlige og kvindelige patienter.
English: Multiple myeloma generally cannot be cured.
Danish: Myelomatose kan normalt ikke helbredes.
English: The maximum plasma concentrations are reached 1-5 hours after administration.
Danish: De maksimale plasmakoncentrationer nås 1-5 timer efter indgivelsen.
English: Children and adolescents Thalidomide Celgene is not recommended for use in children and young people under 18 years.
Danish: Børn og unge Thalidomid bør ikke anvendes til børn og unge under 18 år.
English: Time from randomization ( month )
Danish: Tid fra randomisering (måned)
English: Dear Healthcare Professional letter The Dear Healthcare Professional letter will consist of two parts:
Danish: Kære Sundhedspersonale-brevet Kære Sundhedspersonale-brevet vil bestå af to dele:
English: Co-administration of food delayed absorption but did not alter the overall extent of absorption.
Danish: Indtagelse sammen med måltider forsinkede absorptionen, men ændrede ikke den generelle absorptionsgrad.
English: See also further information in this section under “Warnings and precautions” and “Pregnancy and breast-feeding”.
Danish: Se yderligere oplysninger i dette afsnit under ”Advarsler og forsigtighedsregler” og ”Graviditet og amning”.
English: • She understands the teratogenic risk to the unborn child
Danish: • Hun forstår den teratogene risiko for det ufødte barn.
English: • you do not understand the contraception advice given to you by your doctor or if you do not feel able to follow this advice.
Danish: • Du ikke forstår de råd om svangerskabsforebyggelse, som du har fået af din læge, eller du føler, at du ikke kan følge denne rådgivning.
English: • less than 12 hours have passed: take your capsules immediately.
Danish: • der er gået mindre end 12 timer: Tag dine kapsler med det samme.
English: This can damage the bone and kidneys.
Danish: Dette kan beskadige knoglerne og nyrerne.
English: No fatalities have been reported and all overdose patients recovered without sequelae.
Danish: Der er ikke rapporteret om dødsfald, og alle overdoserede patienter kom sig uden sequelae.
English: Make sure you tell your doctor if you are taking any medicines which:
Danish: Sørg for at fortælle din læge, hvis du tager lægemidler, der:
English: The in vivo relevance of these findings is unknown.
Danish: Disse resultaters relevans in vivo er ikke kendt.
English: Prior to starting treatment
Danish: Før påbegyndelse af behandling
English: The median dose of thalidomide was 217 mg and > 40 % of patients received 9 cycles.
Danish: Mediandosisen af thalidomid var 217 mg og > 40 % af patienterne modtog 9 cyklusser.
English: • As little as one capsule taken by a pregnant woman can cause a baby to have serious birth defects.
Danish: • Så lidt som én kapsel taget af en gravid kvinde kan medføre alvorlige fødselsdefekter hos barnet.
English: EU/1/08/443/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/08/443/001
English: In this study the age range of patients was 65-75 years, with 41 % (183/447) of patients 70 years old or older.
Danish: I dette studie var patienterne 65-75 år; 41 % (183/447) af patienterne var 70 år eller derover.
English: Frequencies are defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1000 to < 1/100); rare (≥ 1/10,000 to < 1/1000); very rare (< 1/10,000) and not known (cannot be estimated from the available data).
Danish: Hyppighederne defineres som: meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100), sjælden (≥ 1/10.000 til < 1/1.000), meget sjælden (< 1/10.000) og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: • more than 12 hours have passed: do not take your capsules.
Danish: • der er gået mere end 12 timer: Tag ikke din e kapsler.
English: No specific dose adjustments are recommended for the elderly ≤ 75 years of age.
Danish: Specifik doseringsjustering til ældre ≤ 75 år anbefales ikke.
English: The prescriber must ensure that:
Danish: Den ordinerende læge skal sikre, at:
English: However your doctor will choose the dose for you, monitor your progress and may adjust your dose.
Danish: Din læge vil imidlertid vælge din dosis, holde øje med din helbredstilstand og evt. justere din dosis.