natgillin/translations-raw huggingface dataset:
Kutan vasodilation med rødme
Cutaneous vasodilatio n with flushing
• Brug af fosfodiesterase-5-hæmmere, da det kan medføre alvorligt blodtryksfald (se pkt.
• Use of phosphodiesterase 5 inhibitors, since this can lead to a serious drop in blood pressure
Der er rapporteret om gastrointestinal perforation i forbindelse med samtidig behandling med nicorandil og kortikosteroider.
Gastrointestinal perforation in the context of concomitant use of nicorandil and corticosteroids has been reported.
Hvis der opstår ulceration(er), skal nicorandil seponeres (se pkt.
If ulceration(s) develops, nicorandil should be discontinued (see section 4.8).
Angicor skal anvendes med forsigtighed til patienter med glucose-6-phosphat-dehydrogenasemangel.
G6PD deficiency <Invented name> should be used with caution in patients with glucose-6-phosphate-dehydrogenase deficiency.
• hvis du er allergisk over for nicorandil eller et af de øvrige indholdsstoffer i Angicor (angivet i punkt 6).
Do not take <Invented name>: • if you are allergic to nicorandil or any of the other ingredients of this medicine (listed in section
Tag emballagen med. Du kan få symptomer på nedsat blodtryk som f.eks. svimmelhed eller svaghedsfølelse.
You may feel blood pressure lowering effect such as dizziness, feeling of weakness.
Gastrointestinale ulcerationer (stomatitis, aftose, sår i munden, sår på tungen, sår på tyndtarmen, sår på tyktarmen, analt ulcus) (se nedenfor og pkt.
Gastrointestina l ulcerations (stomatitis, aphtosis, mouth ulcer, tongue ulcer, small intestinal ulcer, large intestinal ulcer, anal ulcer) (see below and section 4.4)
Der er rapporteret om gastrointestinal blødning sekundært til gastrointestinal ulceration i forbindelse med behandling med nicorandil.
Gastrointestinal haemorrhage secondary to gastrointestinal ulceration has been reported with nicorandil.
• Medicin, der øger indholdet af kalium i blodet.
• Medicines that increase blood potassium levels.
- Ulcerationer i øjet
- Eye ulcerations
Blodtryksfald (se pkt.4.4)
Decrease in blood pressure (see section
• Akut lungeødem
• Acute pulmonary oedema
Dette kan medføre problemer som f.eks. blødning, fistler (unormal rør-lignende passage fra et hulrum i kroppen til et andet eller til huden), perforationer (huller) og bylder, især hvis du har en divertikelsygdom (en sygdom i fordøjelsessystemet, som påvirker tyktarmen).
This can develop problems such as bleeding, fistula, wholes, abscess, especially if you have diverticular disease
Gastrointestinal blødning (se pkt.
Gastrointestina l haemorrhage (see section
DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN
DATE OF FIRST AUTHORISATION: RENEWAL OF THE AUTHORISATION [To be completed nationally]
Nicorandil skal anvendes med forsigtighed sammen med andre lægemidler med blodtrykssænkende effekt (se pkt.
Caution is advised if nicorandil is used in combination with other medicinal products with blood pressure lowering effect (see section 4.5 and 4.8).
Angicor administreres oralt.
Method of administration <Invented name> is administered by oral route.
FARMACEUTISKE OPLYSNINGER [Udfyldes nationalt]
PHARMACEUTICAL PARTICULARS [To be completed nationally]
Brug af anden medicin sammen med Angicor
Other medicines and <Invented name>
• Hudrødme
Dizziness
Det skal du vide, før du begynder at tage Angicor Sådan skal du tage Angicor Bivirkninger
What <Invented name> is and what it is used for What you need to know before you take <Invented name> How to take <Invented name> Possible side effects
Meget almindelig (kan forekomme hos flere end 1 ud af 10 personer)
Other side effects include: Very common (may affect more than 1 in 10 people)
Angicor og relaterede navne (Se bilag I) 10 mg tabletter Angicor og relaterede navne (Se bilag I) 20 mg tabletter [Se bilag I - Udfyldes nationalt] nicorandil
Ikorel and associated names (see Annex I) 10 mg tablets Dancor and associated names (see Annex I) 10 mg tablets Ikorel and associated names (see Annex I) 20 mg tablets] Dancor and associated names (see Annex I) 20 mg tablets [See Annex I - To be completed nationally] nicorandil
ANDET Tørremidlet må ikke sluges.
OTHER Do not swallow drying agent.
Svaghedsfølels e
Headach e
Angicor og relaterede navne (Se bilag I) 10 mg tabletter Angicor og relaterede navne (Se bilag I) 20 mg tabletter [Se bilag I - Udfyldes nationalt]
Ikorel and associated names (see Annex I) 10 mg tablets Dancor and associated names (see Annex I) 10 mg tablets Ikorel and associated names (see Annex I) 20 mg tablets] Dancor and associated names (see Annex I) 20 mg tablets [See Annex I - To be completed nationally]
(fosfodiesterase-hæmmere) eller medicin til behandling af forhøjet blodtryk i lungerne som f.eks. riociguat (guanylatcyklase-stimulatorer).
• if you are taking medicines to treat erectile dysfunction such as sildenafil, tadalfil, vardenafil (phosphodiesterase inhibitors) or medicines to treat pulmonary hypertension such as riociguat (guanylate cyclase stimulators).
• Skader på hornhinden
• Cornea injuries
Sådan skal du tage Angicor
How to take <Invented name>
Mundsår
Desiccant
4.4) rapporteret i post-marketingovervågning af nicorandil.
In addition, serious adverse reactions including ulcerations and their complications (see section 4.4) were reported during the post marketing surveillance of nicorandil.
- Gem indlægssedlen.
Take the medicine pack with you.
Mave-tarm-kanalen Rektal blødning
Rectal bleeding
Angicor kan forårsage svimmelhed eller svaghedsfølelse.
Driving and using machines <Invented name> may cause dizziness or weakness.
• Mavesmerter.
• Stomach aches.
INFORMATION I BRAILLE-SKRIFT Angicor og relaterede navne (Se bilag I) 10 mg Angicor og relaterede navne (Se bilag I) 20 mg
Ikorel and associated names (see Annex I) 10 mg tablets Dancor and associated names (see Annex I) 10 mg tablets Ikorel and associated names (see Annex I) 20 mg tablets] Dancor and associated names (see Annex I) 20 mg tablets
EU/2/04/044/013 Aivlosin 42,5 mg/g Oralt pulver
EU/2/04/044/014 Aivolsin 625 mg/g Granules for use in drinking water
Indgivelsesvej Emballage
Packaging Content Package size
Dette sammendrag blev sidst ajourført i 03-2016
This summary was last updated in 03-2016.
Der skal udvises yderligere forsigtighed i op til seks måneder.
Further care must be taken for up to six months.
Dosis er 0,15 mg pr. kg legemsvægt.
The dose is 0.15 mg per kilogram body weight.
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Foscan den 24. oktober 2001.
The European Commission granted a marketing authorisation valid throughout the European Union for Foscan on 24 October 2001.
Den fuldstændige EPAR for Foscan findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
The full EPAR for Foscan can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Andre oplysninger om Foscan
Other information about Foscan
Hvis behandlingen må gentages, skal der gå mindst fire uger, før dette finder sted.
If a second treatment is necessary, this should take place at least four weeks later.
Hvert område af svulsten bør kun belyses én gang under hver behandling.
Each area of the tumour should be illuminated only once during each treatment.
Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Foscan.
This is a summary of the European public assessment report (EPAR) for Foscan.
Hos ca. en fjerdedel af patienterne i denne undersøgelse blev svulsten desuden mindre.
Around a quarter of the patients in this study also had a reduction in tumour size.
Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om anvendelsesbetingelserne for Foscan.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Foscan.
Derved dræbes cellerne, fordi det ødelægger deres bestanddele, f.eks. proteiner og DNA.
This kills the cells by reacting with and destroying their components, such as their proteins and DNA.
Men i den undersøgelse, der registrerede symptomlindringen ved fremskreden hoved-hals-kræft, fik 28 (22 %) af de 128 vurderede patienter en væsentlig bedring i de mest generende symptomer.
However, in the study looking at improving symptoms of advanced head and neck cancer, 28 (22%) of the 128 patients assessed had a significant improvement in their most troubling symptom.
Udvalget var derfor af den opfattelse, at fordelene ved Foscan opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse.
Therefore, the Committee decided that Foscan's benefits are greater than its risks and recommended that it be given marketing authorisation.
Hvis du ønsker yderligere oplysninger om behandling med Foscan, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
For more information about treatment with Foscan, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
I alle undersøgelserne blev behandlingens virkning vurderet 12 til 16 uger efter den sidste behandling med Foscan, men Foscan blev ikke sammenlignet med andre behandlinger.
In all studies, the response was assessed between 12 and 16 weeks after the final treatment with Foscan, but Foscan was not compared with any other treatment.
Lægemidlet indgives gennem en fastliggende intravenøs sonde (et tyndt rør, der permanent er lagt ind i en vene) som en enkelt langsom indsprøjtning over mindst seks minutter.
The medicine is given by an indwelling intravenous cannula (a thin tube permanently inserted into a vein) as a single slow injection over at least six minutes.
Under behandlingen skal de øvrige områder af kroppen beskyttes mod lyset, så lægemidlets aktivering begrænses til svulsten.
During treatment, other areas of the body should be shielded from the light so that the activation of the medicine is limited to the tumour.
Det anvendes til patienter, for hvem anden behandling ikke længere virker, og som hverken er egnet til stråleterapi, operation eller systemisk kemoterapi (lægemidler, der anvendes til behandling af kræft; "systemisk" betyder, at de gives, så det virker i hele kroppen).
It is used in patients in whom other treatments have stopped working, and who are not suitable for radiotherapy (treatment with radiation), surgery or systemic chemotherapy (medicines used to treat cancer; ‘systemic' means that they are given as treatments throughout the body).
Foscan må kun gives på en specialafdeling for kræft, hvor patientens behandling kan vurderes af et team under opsyn af en læge med erfaring i brug af fotodynamisk behandling (behandling med anvendelse af lys).
Foscan must only be given in a specialist cancer centre where a team can assess the patient's treatment under the supervision of a doctor who has experience in photodynamic therapy (treatment that uses light).
Foscan er en injektionsvæske (opløsning), der indeholder det aktive stof temoporfin (1 mg/ml).
Foscan is a solution for injection containing the active substance temoporfin (1 mg/ml).
I de tre første undersøgelser blev det registreret, om svulsten var forsvundet efter indtil tre behandlinger med Foscan hos i alt 189 patienter.
The first three studies looked at whether the tumour was eradicated after up to three treatments with Foscan in a total of 189 patients.
Når indsprøjtningen af Foscan gives, fordeler temoporfin sig i hele kroppen, også i svulsten.
When Foscan is injected, temoporfin is distributed within the body, including within the tumour.
The CHMP konkluderede, at Foscan's virkning på reduktion af symptomer forbundet med fremskreden hoved-hals-kræft var interessant.
The CHMP concluded that Foscan's effects on relieving the symptoms associated with advanced head and neck cancer were of interest.
Det aktive stof i Foscan, temoporfin, er et fotosensibiliserende middel (dvs. et stof, der ændrer sig ved udsættelse for lys).
The active substance in Foscan, temoporfin, is a photosensitising agent (a substance that changes when exposed to light).
Hvilken risiko er der forbundet med Foscan?
What is the risk associated with Foscan?
I den fjerde undersøgelse registreredes bedringen i symptomer hos 220 patienter, der havde fremskreden kræft i hoved eller hals, og som hverken kunne behandles med operation eller stråler.
The fourth study looked at the reduction of symptoms in 220 patients with advanced head or neck cancer who could not receive surgery or radiotherapy.
Patienter, der får Foscan, bør undgå udsættelse for sollys eller andet stærkt lys i indtil to måneder efter indsprøjtningen for at undgå skoldning af huden.
Patients receiving Foscan should take care to avoid exposure to sun light or bright light for two weeks after injection to avoid skin burns.
Foscan må ikke anvendes til patienter med porfyri (manglende evne til at nedbryde porfyriner), andre sygdomme der forværres af lys, allergi over for porfyriner eller svulster, der har bredt sig til et hovedblodkar i eller tæt på det område, der skal belyses med laseren.
Foscan must not be used in patients with porphyria (an inability to break down porphyrins), other diseases made worse by light, allergy to porphyrins, or tumours that are spreading into a main blood vessel in or next to the area where the laser is to be shone.
De almindeligste bivirkninger af Foscan (der ses hos mere end 1 af 10 patienter) er smerter på det belyste område (såsom i ansigtet), hovedpine, smerter på injektionsstedet, blødning, ardannelse, nekrotiserende stomatitis, celle- eller vævsdød i munden, synkebesvær, hævet ansigt og tunge samt forstoppelse.
The most common side effects with Foscan (seen in more than 1 patient in 10) are pain in the illuminated area (such as pain in the face), headache, pain at the injection site, haemorrhage (bleeding), scarring, necrotising stomatitis (death of cells or tissue in the mouth), dysphagia (difficulty swallowing), oedema (swelling) in the illuminated area (such as swelling of the face and tongue) and constipation.
Foscan anvendes til at lindre symptomerne ved fremskreden pladecellekræft i hoved og hals (en kræftform, der udgår fra de celler, der indvendigt beklæder mund, næse, hals eller ører).
Foscan is used to relieve the symptoms of advanced head and neck squamous cell carcinoma (a type of cancer that starts in the cells lining the mouth, nose, throat or ear).
Der er udført fire hovedundersøgelser af Foscan hos i alt 409 patienter med hoved-hals-kræft.
Foscan has been studied in four main studies involving a total of 409 patients with head or neck cancer.
Foscan bør ikke anvendes hos patienter, der er overfølsomme (allergiske) over for temoporfin eller andre af indholdsstofferne.
Foscan must not be used in people who are hypersensitive (allergic) to temoporfin or any of the other ingredients.
Hvorfor blev Foscan godkendt?
Why has Foscan been approved?
Foscan må heller ikke anvendes til patienter, der skal opereres inden for de næste 30 dage, patienter med øjensygdomme, der inden for de næste 30 dage måtte have behov for en undersøgelse med en spaltelampe (et instrument, øjenlægen bruger til at se ind i øjet) eller patienter, der i forvejen behandles med et fotosensibiliserende middel.
Foscan must also not be used in patients who have an operation planned in the next 30 days, who have an eye disease that is likely to need examination using a ‘slit lamp' (an instrument used by eye specialists to look into the eye) in the next 30 days, or who are already being treated with a photosensitising agent.
Behandlingen med Foscan finder sted i to trin: Først gives lægemidlet.
Treatment with Foscan is a two-step process: the medicine is given first, and then it is activated using a laser.
Den fuldstændige liste over de indberettede bivirkninger for Foscan fremgår af indlægssedlen.
For the full list of all side effects reported with Foscan, see the package leaflet.
Resultaterne af de første tre undersøgelser var ikke tilstrækkelige til at vise, at Foscan kan fjerne svulster i hoved og hals.
The results of the first three studies were insufficient to support the use of Foscan in the eradication of head and neck cancer tumours.
Fire dage senere belyses et område svarende til hele svulstens overflade samt 0,5 cm ind over det omgivende væv med laserlys.
Four days later, the entire surface of the tumour and the surrounding 0.5 cm margin is illuminated with light from a laser at a specific wavelength, using a fibre-optic cable.
EPAR - Sammendrag for offentligheden temoporfin
Foscan temoporfin
Kun svulstområdet belyses; derved bliver cellebeskadigelsen begrænset til svulstcellerne, hvorimod de øvrige områder af kroppen er upåvirkede.
By restricting the illumination to the tumour, cell damage is limited to the tumour cells, leaving other areas of the body unaffected.
Det reagerer derved med ilten i cellerne, så der dannes en meget reaktiv og giftig form for ilt.
When it is illuminated with laser light of a specific wavelength, temoporfin is activated and reacts with oxygen in the cells to create a highly reactive and toxic type of oxygen.
Hvad er Foscan?
What is Foscan?
Hvad anvendes Foscan til?
What is Foscan used for?
Hvilken fordel viser undersøgelserne, at der er ved Foscan?
What benefit has Foscan shown during the studies?
Hvordan blev Foscan undersøgt?
How has Foscan been studied?
Hvordan anvendes Foscan?
How is Foscan used?
Hvordan virker Foscan?
How does Foscan work?
[Injektionsvæske (i.m.)]
[Solution for injection (i.m.)]
CMDh omformulerede derfor er dette afsnit som følger:
The CMDh therefore reworded this section, as follows:
Lægemidler indeholdende flupirtin er på nuværende tidspunkt godkendt under receptpligt i 11 EUmedlemsstater: Bulgarien, Estland, Italien, Letland, Litauen, Polen, Portugal, Rumænien, Slovakiet, Tyskland og Ungarn.
Flupirtine-containing medicinal products are currently approved in 11 Member States (MSs) of the Union on prescription only: Bulgaria, Estonia, Germany, Hungary, Italy, Latvia, Lithuania, Poland, Portugal, Romania and Slovak Republic.
Dette er navnlig vigtigt ved rygsmertemodellen på grund af den forventede høje andel af spontan remission.
This is particularly important with regards back pain model due to the expected high rate of spontaneous remission.
Patienteksponeringen for flupirtin var større i Tyskland og er steget konstant fra 7,9 mio. DDD i 2001 til 28,1 mio. DDD i 2011.
Patient exposure to flupirtine was greater in Germany and has increased steadily from 7,9 million DDD in 2001 to 28,1 million DDD in 2011.
Andre styrker og lægemiddelformer markedsføres kun i Tyskland.
Other dosages and pharmaceutical forms are available in Germany only.
PRAC anbefalede desuden, at periodiske opdaterede sikkerhedsindberetninger indsendes årligt.
The PRAC also recommended that Periodic Safety Update Reports should be submitted yearly.
Samlet resumé af PRAC's videnskabelige vurdering af lægemidler indeholdende flupirtin
Overall summary of the scientific evaluation of flupirtine containing medicinal products by PRAC
Det virker desuden som en funktionel Nmethyl-D-aspartat (NMDA)-receptorantagonist.
It also acts as functional N-methyl-Daspartate (NMDA) receptor antagonist.
Den af WHO fastsatte døgndosis (DDD) ved oral anvendelse af flupirtin er 400 mg.
The WHO defined daily dose (DDD) for flupirtine oral is 400 mg.
Tilsammen er 11,8 mio. patienter siden 1999 blevet behandlet med produkter indeholdende flupirtin.
Overall, 11.8 million patients have been treated with flupirtine containing medicinal products since
400 mg tabletten med modificeret udløsning har siden 2007 været den oftest ordinerede formulering i EU, skønt den kun er godkendt i Tyskland.
The 400 mg modified release tablets, although only authorised in Germany, is the most prescribed formulation in the Union since 2007.
De tyske kompetente nationale myndigheder (BfArM) påpegede et stigende antal hepatotoksiske reaktioner (antagelig idiosynkratiske), der var indberettet i forbindelse med flupirtin.
The German National Competent Authority (BfArM) identified a growing number of hepatotoxicity reactions (probably idiosyncratic) reported in association with flupirtine.
Det skal du vide, før du begynder at bruge <lægemidlets navn> [Nedenstående ordlyd indsættes i de pågældende afsnit]
What you need to know before you use < product name > [The wording below should be inserted in the relevant sections]
Michel MC, Radziszewski P, Falconer C, Marschall-Kehrel D, Blot K. Unexpected frequent hepatotoxicity of a prescription drug, flupirtin, marketed for about 30 years.
Michel MC, Radziszewski P, Falconer C, Marschall-Kehrel D, Blot K. Unexpected frequent hepatotoxicity of a prescription drug, flupirtine, marketed for about 30 years.
Indberetningsfrekvensen af hepatiske tilfælde med flupirtin (uanset årsagssammenhæng) er 15,2 tilfælde/100 000 patientår (baseret på en patienteksponering på 893 000 patientår).
The reporting rate for hepatic cases with flupirtine (regardless of causality) is of 15,2 cases/100 000 patients years (based on a patient exposure of 893, 000 patients year).
Flupirtin er en “selektiv kaliumkanalåbner” (SNEPCO), som virker ved at nedsætte den elektriske overaktivitet, der er årsag til mange smertetilstande.
Flupirtine is a ‘selective neuronal potassium channel opener' (SNEPCO) that acts by reducing the excessive electrical activity that leads to many pain states.
Flupirtin leveres som 100 mg kapsler med hurtig udløsning, 400 mg tabletter med modificeret udløsning, 75 mg og 150 mg suppositorier samt injektionsvæske (100 mg).
Flupirtine is available as 100 mg immediate release capsules, 400 mg modified release tablet, 75 mg and 150 mg suppositories and as solution for injection (100 mg).
Endnu en publikation4 beskrev seks tilfælde af flupirtin-induceret leverskade, hvoraf det ene krævede transplantation.
Another publication4 described six cases of flupirtine-induced liver injury, including one requiring liver transplantation.
Open study over 12 months, single blind subsequent observation period of 14 days (including an „Additional evaluation about a group of very old patients > 80 years“) Degussa-Report No. D-09998 / 75 057 C, (for publication see also below) Herrmann WM, Hiersemenzel R, Aigner M et al.: Die Langzeitverträglichkeit von Flupirtin.
Open study over 12 months, single blind subsequent observation period of 14 days (including an „Additional evaluation about a group of very old patients > 80 years“) Degussa-Report No. D-09998 / 75 057 C, (for publication see also below)
Som led i risikominimeringsforanstaltningerne anbefalede PRAC ændringer af produktinformationen for alle lægemidler indeholdende flupirtin.
As part of the risk minimisation measures the PRAC recommended amendments to the product information for all flupirtine containing medicinal products.
Uberall MA, Mueller-Schwefe GH, Terhaag B. Efficacy and safety of flupirtin modified release for the management of moderate to severe chronic low back pain: results of SUPREME, a prospective randomized, double-blind, placebo- and active-controlled parallel-group phase IV study.
Uberall MA, Mueller-Schwefe GH, Terhaag B. Efficacy and safety of flupirtine modified release for the management of moderate to severe chronic low back pain: results of SUPREME, a prospective randomized, double-blind, placebo- and active-controlled parallel-group phase IV study.
1 Li C, Ni J, Wang Z et al. Analgesic efficacy and tolerability of flupirtin vs. tramadol in patients with subacute low back pain: a double-blind multicentre trial.
1 Li C, Ni J, Wang Z et al. Analgesic efficacy and tolerability of flupirtine vs. tramadol in patients with subacute low back pain: a double-blind multicentre trial.
CMDh fandt det imidlertid nødvendigt at ændre den foreslåede ordlyd i indlægssedlens afsnit 2 for nøjagtigt at afspejle de af PRAC anbefalede ændringer af produktresuméets punkt 4.3 “kontraindikationer”.
However, the CMDh considered that changes were necessary to the wording proposed in section 2 of the PL, in order to accurately reflect the PRAC recommended amendments to the SmPC section 4.3 “contraindications”.