FrancophonIA/ELRC3.0 huggingface dataset:
English: In addition, patients with certain cardiovascular risk factors (such as hypertension, hyperlipidaemia, diabetes mellitus or smoking) should only use diclofenac after careful consideration and therefore the warnings should also be updated to reflect this.
Danish: Til patienter med visse kardiovaskulære risikofaktorer (såsom hypertension, hyperlipidæmi, diabetes mellitus eller rygning) bør diclofenac desuden kun ordineres efter nøje overvejelse, hvorfor advarslerne skal opdateres, så de afspejler dette.
English: Although the data point towards a dose dependent effect on thrombotic risk associated with the use of diclofenac, particularly at high dose, it is difficult to establish a clear cut-off dose above which the risks become significantly increased.
Danish: Skønt dataene tyder på, at den trombotiske risiko ved diclofenac er dosisafhængig, navnlig ved høje doser, er det vanskeligt at angive en klar skæringsdosis, ved hvilken risiciene stiger væsentligt.
English: The PRAC therefore recommended an amendment to the product information for diclofenac to include an updated contraindication in patients with established congestive heart failure (NYHA II-IV), ischemic heart disease, peripheral arterial disease and/or cerebrovascular disease.
Danish: PRAC anbefalede derfor en ændring af produktinformationen for diclofenac med en opdateret kontraindikation hos patienter med manifest venstresidig hjerteinsufficiens (NYHA II-IV), iskæmisk hjertesygdom, perifer arteriel sygdom og/eller cerebrovaskulær sygdom.
English: Recognised risks associated with NSAID treatment in general, and with diclofenac treatment in particular, include serious gastrointestinal effects including PUB (perforation, ulcer, bleeding), cardio-renal effects, hepatic effects and skin reactions (including Stevens Johnson syndrome and toxic epidermal necrolysis).
Danish: De kendte risici ved behandling med NSAID i almindelighed, og med diclofenac i særdeleshed, er alvorlige gastrointestinale virkninger i form af perforation, ulcus og blødning, kardio-renale effekter, hepatiske effekter og hudreaktioner i form af Stevens Johnsons syndrom og toksisk epidermal nekrolyse.
English: Diclofenac containing medicinal products (systemic formulations) are available as tablets, capsules for oral administration, suppositories for rectal administration and solutions for intravenous or intramuscular injection.
Danish: Systemiske lægemidler indeholdende diclofenac findes som tabletter og kapsler til oral administration, suppositorier til rektal administration og injektionsvæsker (opløsning) til intravenøs og intramuskulær injektion.
English: It was observed that these are similar to those of selective Cox-2 inhibitors.
Danish: Det konstateredes, at disse risici svarer til risiciene ved selektive COX-2-hæmmere
English: A new review was considered necessary and was initiated to address the cardiovascular safety concerns for diclofenac and their impact on the benefit-risk balance of diclofenac containing medicinal products (systemic formulations).
Danish: Der blev indledt en ny gennemgang med henblik på de kardiovaskulære sikkerhedsproblemer ved diclofenac og betydningen heraf for benefit/risk-forholdet for systemiske lægemidler indeholdende diclofenac.
English: • The PRAC considered the procedure under Article 31 of Directive 2001/83/EC resulting from pharmacovigilance data, for diclofenac containing medicinal products (systemic formulations).
Danish: • PRAC fulgte proceduren i overensstemmelse med artikel 31 i direktiv 2001/83/EF på foranledning af lægemiddelovervågningsdata for systemiske lægemidler indeholdende diclofenac
English: Based on the available data to date, the PRAC therefore concluded that the cardiovascular thrombotic risk cannot be excluded across all doses of diclofenac, especially in patients with pre-existing co-morbidities.
Danish: På grundlag af de foreliggende data konkluderede PRAC derfor, at der ikke kan udelukkes kardiovaskulær tromboserisiko ved nogen dosis af diclofenac, navnlig ikke hos patienter med præeksisterende komorbiditet.
English: Considering that an increased cardiovascular risk with diclofenac is observed, and this appears similar to that of selective Cox-2 inhibitors, it therefore follows that any risk minimisation in place for Cox-2 inhibitors with respect to cardiovascular risk should also apply to diclofenac.
Danish: I betragtning af, at der iagttages samme forhøjelse af den kardiovaskulære risiko med diclofenac som med selektive COX-2-hæmmere, bør enhver foranstaltning til minimering af kardiovaskulær risiko, der finder anvendelse for COX-2-hæmmere, også finde anvendelse for diclofenac.
English: Another evaluation conducted by the CHMP in 20122 considered all available published evidence to date from meta-analysis of clinical trials and observational studies, and also epidemiological studies.
Danish: I 2012 foretog CHMP endnu en gennemgang2 af al foreliggende evidens fra metaanalyse af kliniske undersøgelser og observationsundersøgelser samt fra epidemiologiske undersøgelser.
English: An increased risk with diclofenac was also observed in the SOS nested-cases control studies across all databases and for both myocardial infarction and ischaemic stroke.
Danish: Der blev også fundet forhøjet risiko ved diclofenac i de undersøgelser med indlejrede kontroller, der var en del af SOS-projektet, og som blev udført på tværs af alle databaser for både myokardieinfarkt og iskæmisk apopleksi.
English: • The PRAC considered the totality of the data available in relation to the cardiovascular safety of diclofenac containing medicinal products, acknowledging the conclusions from previous reviews by the CHMP, the submissions by marketing authorisation holders in writing and at an oral explanation, and emerging data from independent researchers.
Danish: • PRAC tog hensyn til alle foreliggende data vedrørende den kardiovaskulære sikkerhed af lægemidler indeholdende diclofenac, idet udvalget anerkendte konklusionerne af tidligere gennemgange foretaget af CHMP, markedsføringstilladelsesindehavernes skiftlige oplysninger og mundtlige forklaring samt nye data fra uafhængige forskere
English: • The PRAC concluded that in view of the currently available safety data in order to maintain a favourable benefit/risk, diclofenac containing medicinal products should be contraindicated in patients with established congestive heart failure (NYHA II-IV), ischemic heart disease, peripheral arterial disease and/or cerebrovascular disease.
Danish: • PRAC konkluderede, at på baggrund af de foreliggende sikkerhedsdata og med henblik på opretholdelse af et positivt benefit/risk-forhold bør lægemidler indeholdende diclofenac være kontraindiceret hos patienter med manifest venstresidig hjerteinsufficiens (NYHA II-IV), iskæmisk hjertesygdom, perifer arteriel sygdom og/eller cerebrovaskulær sygdom.
English: The CMDh, having considered the PRAC recommendation dated 13 June 2013 pursuant to Article 107k(1) and (2) of Directive 2001/83/EC, reached a position on the variation of the marketing authorisations of diclofenac containing medicinal products for which the amendments to the product information are set out in annex III.
Danish: Efter at have gennemgået PRAC's anbefaling af 13. juni 2013 i medfør af artikel 107, stk. 1 og 2, i direktiv 2001/83/EF tillsluttede CMDh sig ændring af markedsføringstilladelserne for lægemidler indeholdende diclofenac, for hvilke ændringerne af produktinformationen fremgår af bilag III.
English: Risk minimisation measures (in the form of contraindications and warnings in the product information) were implemented at the time for Cox-2 inhibitors.
Danish: Der blev dengang indført risikominimeringsforanstaltninger for COX-2-hæmmere (i form af kontraindikationer og advarsler i produktinformationen).
English: The study, which looked at more than 600 randomised clinical trials, concluded that the vascular risks of high dose diclofenac are comparable to Cox-2 inhibitors.
Danish: Analysen gennemgik mere end 600 randomiserede kliniske undersøgelser og konkluderede, at de vaskulære risici med diclofenac i høje doser svarer til risiciene med COX-2-hæmmerne.
English: Meta-analyses of observational data and individual observational studies also consistently indicated that diclofenac is associated with a similar level of risk as Cox-2 inhibitors.
Danish: Metaanalyser af observationsdata og individuelle observationsundersøgelser tydede ligeledes samstemmende på, at risikoen ved diclofenac er af samme grad som ved COX-2-hæmmere.
English: Moreover, the general rule that NSAIDs should be used at the lowest dose for the shortest duration possible should be consistently implemented in the posology section of the product information.
Danish: Afsnittet om dosering i produktinformationen bør derudover konsekvent nævne den generelle regel om, at NSAID bør anvendes i lavest mulige dosering i kortest mulig tid
English: Having noted all of the above, the PRAC concluded that the benefit-risk balance for diclofenac containing medicinal products (systemic formulations) remains favourable subject to the agreed restrictions, warnings, other changes to the product information and additional risk minimisation measures, in the form of a DHPC letter.
Danish: På baggrund af alt det ovennævnte konkluderede PRAC, at benefit/risk-forholdet for systemiske lægemidler indeholdende diclofenac fortsat er positivt under forudsætning af de vedtagne begrænsninger, advarsler, andre ændringer i produktinformationen og supplerende risikominimeringsforanstaltninger i form af en direkte meddelelse til sundhedspersoner.
English: Epidemiological and clinical trial data on the cardiovascular risks of NSAIDs, including diclofenac, were previously reviewed by the Committee for Medicinal Products for Human Use (CHMP).
Danish: Udvalget for Lægemidler til Mennesker (CHMP) har tidligere gennemgået de kardiovaskulære risici ved NSAID, herunder diclofenac, på grundlag af data fra epidemiologiske og kliniske undersøgelser.
English: The new evidence provided by marketing authorisation holders including evidence from new casecontrol studies and retrospective studies add to the evidence of an increased risk with diclofenac
Danish: Den nye dokumentation, der blev fremlagt af indehaverne af markedsføringstilladelse, herunder data fra nye case-kontrolundersøgelser og retrospektive undersøgelser, giver yderligere evidens for, at der er større risiko med diclofenac end med andre NSAID, og at risikoen med diclofenac svarer til risikoen med coxib-præparater.
English: Schjerning Olsen et al (2011) provided data on risks in relation to duration of exposure and found that the risks associated with diclofenac were very similar to those of coxibs at all time points.
Danish: (2011) undersøgte data om risici i relation til eksponeringsvarighed og fandt, at risiciene ved diclofenac på alle tidspunkter nøje svarede til risiciene ved coxib-præparater.
English: • The PRAC considered that with regards to the arterial thrombotic risks of diclofenac, the data available to date from randomised clinical trials, observational studies and individual epidemiological studies, including meta-analysis thereof, allow the conclusion that diclofenac is associated with increased cardiovascular risks.
Danish: • vedrørende risikoen for arterielle tromboser fandt PRAC, at det kan konkluderes, at diclofenac er forbundet med øgede kardiovaskulære risici, hvilket er baseret på de foreliggende data fra randomiserede kliniske undersøgelser, observationsundersøgelser og individuelle epidemiologiske undersøgelser samt metaanalyse heraf.
English: The PRAC concluded that the benefit-risk balance for diclofenac containing medicinal products (systemic formulations) remains favourable subject to the agreed restrictions, warnings, other changes to the product information and additional risk minimisation measures, in the form of a communication letter.
Danish: Hovedelementerne i en direkte meddelelse til sundhedspersoner blev vedtaget tillige med en tidsplan for udsendelsen konkluderede PRAC, at benefit/risk-forholdet for systemiske lægemidler indeholdende diclofenac fortsat er positivt under forudsætning af de vedtagne begrænsninger, advarsler, andre ændringer i produktinformationen og supplerende risikominimeringsforanstaltninger i form af en direkte meddelelse til sundhedspersoner.
English: The data available today do not allow conclusion on the specific mechanisms underlying the cardiovascular thrombotic risks of diclofenac, although several studies have explored different options and it can be noted that is unlikely that one single mechanism would explain the risk.
Danish: Af de foreliggende data kan der ikke drages konklusioner om de konkrete mekanismer bag de kardiovaskulære trombotiske risici ved diclofenac, skønt de er forsøgt nærmere udredt i flere undersøgelser.
English: In 2006 it was concluded that a small increase in the absolute risk of thrombotic events could not be excluded for NSAIDs as a class, especially when used at high-doses and long-term therapy, although the risk was considered to be higher for the selective cyclooxygenase-2 (Cox-2) inhibitors (also known as coxibs) compared to NSAIDs.
Danish: I 2006 konkluderedes det, at det ikke kunne udelukkes, at klassen af NSAID som helhed medfører en let forhøjelse af den absolutte risiko for trombotiske hændelser, navnlig i høje doser ved langvarig behandling.
English: 1 For more details on the MEDAL programme, including its components, please refer to the assessment report for the review conducted in 2006 at http://www.ema.europa.eu/docs/en_GB/document_library/Report/2010/01/WC500054344.pdf.
Danish: gennemgangen: http://www.ema.europa.eu/docs/en_GB/document_library/Report/2010/01/WC500054344.pdf.
English: The CMDh, having considered the PRAC recommendation dated 13 June 2013 with regards to diclofenac containing medicinal products (systemic formulations), 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 Lægemiddelovervågning) anbefaling af 13. juni 2013 for systemiske lægemidler indeholdende diclofenac.
English: Results of the ‘safety of non-steroidal anti-inflammatory drugs' (SOS) research project funded by the European Commission under the Seventh Framework Programme were considered in the review that concluded that available evidence regarding diclofenac seemed to consistently point towards a less favourable cardiovascular risk profile compared to other NSAIDs, and similar risks as those of Cox-2 inhibitors.
Danish: Ved gennemgangen konkluderedes, at de foreliggende data samstemmende tyder på en mindre fordelagtig kardiovaskulær risikoprofil af diclofenac end af andre NSAID, og at risiciene svarer til risiciene ved COX-2-hæmmere.
English: These infections are usually easily treated.
Danish: Disse infektioner er sædvanligvis nemme at behandle.
English: From a microbiological point of view, the product should be used immediately.
Danish: Ud fra et mikrobiologisk synspunkt bør lægemidlet anvendes med det samme.
English: Children and adolescents This medicine should not be given to children and adolescents less than 18 years of age.
Danish: Børn og unge Dette lægemiddel bør ikke gives til børn og unge under 18 år.
English: If your partner becomes pregnant within three months of your treatment, you must immediately tell your doctor.
Danish: Hvis din partner bliver gravid inden for tre måneder efter din behandling, skal du straks fortælle det til lægen.
English: The condition gets better on its own or with treatment of the infection.
Danish: Tilstanden bedres af sig selv eller ved behandling af infektionen.
English: The case resolved within three days.
Danish: Tilstanden fortog sig i løbet af tre dage.
English: Co-administration should be done with caution and close monitoring is recommended.
Danish: Samtidig administration skal ske med forsigtighed, og tæt overvågning anbefales.
English: All these changes were considered to be incidental and probably related to the intravenous administration procedure.
Danish: Alle disse forandringer vurderedes at være tilfældige og var sandsynligvis relateret til den intravenøse administrationsprocedure.
English: The injection lasts 10 minutes.
Danish: Injektionen varer i 10 minutter.
English: However, all stages of spermatogenesis have been observed in animal.
Danish: Alle stadier af spermatogenese er imidlertid observeret hos dyr.
English: Phase III Study (PCM301)
Danish: Fase III-undersøgelse (PCM301)
English: • Explain what side effects the Patient might expect and the likelihood of him getting them
Danish: • Forklaring af, hvilke bivirkninger patienterne kan forvente, og sandsynligheden for, at de får dem
English: Submission of final study results:
Danish: Indsendelse af endelige resultater af studiet:
English: All patients had Gleason score ≤ 3 + 3 at baseline.
Danish: Alle patienter havde en Gleason-score ≤ 3 + 3 ved baseline.
English: Store in a refrigerator (2°C-8°C).
Danish: Opbevares i køleskab (2-8 °C).
English: You may also be required to not take certain medicines for several days after the VTP procedure.
Danish: Du kan også være nødt til ikke at tage visse lægemidler i flere dage efter VTP-proceduren.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.
Danish: Hvis det ikke anvendes med det samme, er opbevaringstiden og opbevaringsforholdene før ibrugtagning brugerens ansvar.
English: - Fever, pain and swelling in the area of the operation might occur after the procedure.
Danish: - Feber, smerter og hævelse i operationsområdet kan forekomme efter proceduren.
English: None of these patients required an operation for incontinence.
Danish: Det var ikke nødvendigt at operere nogen af disse patienter for inkontinens.
English: In 5 (2.5 %) patients, the infection was considered serious.
Danish: Hos 5 patienter (2,5 %) vurderedes infektionen at være alvorlig.
English: Do not use after the expiry date which is stated on the shield label after “EXP”.
Danish: Må ikke anvendes efter den udløbsdato, som er angivet på etiketten efter "EXP".
English: The following terms represent a group of related events that describes a medical condition rather than a single event.
Danish: Nedenstående termer dækker en gruppe relaterede hændelser, der mere beskriver en medicinsk tilstand end en enkelt bivirkning.
English: The activated medicine then causes the death of the cancer cells.
Danish: Det aktiverede lægemiddel får derefter kræftcellerne til at dø.
English: In case of bilateral disease (discovered at entry or during follow-up), bilateral treatment was to be applied, either simultaneously or consecutively.
Danish: Ved bilateral sygdom (opdaget ved inklusionen eller opfølgningen) blev der givet bilateral behandling, enten samtidigt eller efter hinanden.
English: Only the lobe that contains the cancer will be treated.
Danish: Kun den lap, der er ramt af kræft, vil blive behandlet.
English: Marketing Authorisation Holder Steba Biotech S.A.
Danish: Indehaver af markedsføringstilladelsen Steba Biotech S.A.
English: In small surgical series, there have been reports of T3 tumours, positive margins and impotence.
Danish: I små kirurgiske serier er der rapporteret om T3-tumorer, positive rande og impotens.
English: This should be taken into consideration (see section 4.4).
Danish: Der skal tages hensyn til dette (se pkt.
English: This may necessitate inserting a catheter inside your bladder through the penis and the catheter will remain in place for a few days or weeks to drain the urine.
Danish: Det kan være nødvendigt at indsætte et kateter i din blære gennem penis, og kateteret skal blive siddende i nogle dage eller uger for at dræne urinen.
English: You will not have to store this medicine.
Danish: Du vil ikke blive bedt om at opbevare lægemidlet.
English: Check with your doctor about the birth control methods to use and how long to use them for.
Danish: Tal med din læge om, hvilke præventionsmetoder I kan anvende, og i hvor lang tid I skal anvende dem.
English: No specific dosage recommendation can be given.
Danish: Der kan ikke gives specifikke dosisanbefalinger.
English: Padeliporfin is retained within the vascular system.
Danish: Padeliporfin forbliver i det vaskulære system.
English: Patients meeting indication criteria
Danish: Patienter, der opfylder indikationskriterierne
English: This medicine is stored under the responsibility of the specialist.
Danish: Dette lægemiddel opbevares under speciallægens ansvar.
English: No metabolites of padeliporfin were observed in these studies.
Danish: Der sås ingen metabolitter af padeliporfin i disse undersøgelser.
English: OATP1B1 and OATP1B3 transporters
Danish: OATP1B1- og OATP1B3-transporterer
English: Table 2 gives baseline characteristics by arm.
Danish: Tabel 2 viser baseline-karakteristika pr. gruppe.
English: Of the 206 subjects randomised TOOKAD-VTP, 10 did not receive treatment for various reasons including study withdrawal, meeting exclusion criteria, non-compliance and other medical events.
Danish: Ud af de 206 forsøgspersoner, der var randomiseret til TOOKAD-VTP, var der 10, som ikke modtog behandling af forskellige grunde, herunder udtrædelse af undersøgelsen, opfyldelse af eksklusionskriterierne, manglende compliance og andre medicinske hændelser.
English: Erectile dysfunction may occur even if radical prostatectomy is avoided.
Danish: Erektil dysfunktion kan forekomme, også selvom der ikke er foretaget radikal prostatektomi.
English: Frequencies are defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to
Danish: Hyppigheden defineres som: meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10) og ikke almindelig (≥ 1/1.000 til < 1/100).
English: Your doctor will also advise what medicines may be substituted where appropriate and when these medicines can be re-started after the VTP procedure.
Danish: Lægen vil også fortælle dig, hvilke lægemidler der i givet fald kan erstattes, og hvornår du kan begynde at tage disse lægemidler igen efter VTP-proceduren.
English: Treatment should not be undertaken in patients where an LDI ≥ 1 cannot be achieved (see section 5.1).
Danish: Der bør ikke gennemføres behandling hos patienter, hvor et LDI ≥ 1 ikke kan opnås (se pkt.
English: Current or prior treatment for prostate cancer.
Danish: Nuværende eller tidligere behandling for prostatacancer.
English: The patient can return to normal activity and tolerate direct sunlight 48 hours after the procedure.
Danish: Patienten kan genoptage sine normale aktiviteter og tåle direkte sollys 48 timer efter proceduren.
English: In addition to the side effects listed previously, other side effects can occur.
Danish: Ud over de nævnte bivirkninger kan en række andre bivirkninger forekomme.
English: There was a correlation between the total energy delivered and the volume of necrosis observed at day 7.
Danish: Der var korrelation mellem den samlede afgivne energi og omfanget af nekrose, der sås på dag 7.
English: Additional VTP procedures of the prostate are not recommended.
Danish: Yderligere VTP-procedurer i prostata anbefales ikke.
English: Adverse reactions reported are listed below in Table 1 by organ class and frequency.
Danish: Indberettede bivirkninger er opstillet nedenfor i tabel 1 efter systemorganklasse og hyppighed.
English: TOOKAD has no influence on the ability to drive or use machines.
Danish: TOOKAD påvirker ikke evnen til at føre motorkøretøj eller betjene maskiner.
English: • Information on the existing therapeutic approaches (including VTP with TOOKAD) for the treatment of the type of prostate cancer
Danish: • Oplysninger om de eksisterende terapeutiske tilgange (herunder VTP med TOOKAD) ved behandling af denne type prostatacancer
English: Sunscreen creams do not protect against near infra-red light and, therefore, do not provide adequate protection.
Danish: Solcreme beskytter ikke mod nærinfrarødt lys og giver derfor ikke tilstrækkelig beskyttelse.
English: Therefore, the possibility for some in vivo metabolism of padeliporfin cannot be fully excluded.
Danish: Derfor kan en vis in vivo-metabolisering af padeliporfin ikke udelukkes fuldstændigt.