FrancophonIA/ELRC3.0 huggingface dataset:
English: - Skin: loss of skin colour, peeling skin, excessive body hair, nail shrinkage, excessive sweating, - General: general condition worsening, weight increase, redness and swelling at the injection site, cancer pain and bleeding, multiple organ failure - Changes in blood tests: high blood sugar, high blood lipids, changes in blood clotting time, high blood cell counts, low or high protein level - Other: frequent urination, blood in urine, neck pain, back pain, breast pain, muscle tightness or cramps, joint swelling, limb discomfort, muscle weakness, arthritis inflammation and pain
Danish: nervebetændelse, forvrænget lugtesans, dysfunktion i hjernen, besvimelse, bevidsthedstab, slagtilfælde, anfald - Øjne: Kløende og røde øjne, allergisk reaktion i øjnene, nedsænket øjenlåg - Ører: Vertigo, tilstoppet øre, ubehag i øret - Hjerte: Uregelmæssigt eller hurtigt hjerteslag, brystsmerter, ansamling af væske rundt om hjertet, hjertetilfælde, hjertesvigt - Blodkar: Inflammation af en vene, hedetur - Lunger og næsepassage: Løbende næse, stemmelidelse, stoppet næse, rødme i svælget, høfeber - Mave og mund: Sure opstød, øget spytafgivelse, mange bøvse, inflammation af læber, mavetarm-lidelse, mundsmerter, unormale muskelsammentrækninger i spiserøret, blokering i mave og tarm, mavesår, retroperitoneal fibrose (aragtig bindevævsforandring bag bughulen), skøre tænder, synkebesvær, sygdom i spytkirtler, hæmorroider - Hud: Tab af hudfarve, afskallende hud, kraftig kropsbehåring, skrumpning af negle, kraftig svedafsondring - Generelt: Generel forværring af tilstand, vægtøgning, rødme og hævelse på injektionsstedet, cancersmerter og blødning, organsvigt af flere organer - Ændringer i blodprøver: Højt blodsukker, højt indhold af fedtstoffer i blodet, ændringer i blodstørkningstid, højt antal blodlegemer, lavt eller højt proteinindhold - Andet: Hyppig vandladning, blod i urinen, nakkesmerter, rygsmerter, brystsmerter, muskelspændthed eller kramper, hævede led, ubehag i arme og ben, muskelsvækkelse, gigtbetændelse og gigtsmerter
English: In a Phase I Teysuno monotherapy study that investigated the pharmacokinetics of components and metabolites in patients with normal and impaired renal function, patients with mild renal impairment (CrCl 51 to 80 ml/min) receiving the same monotherapy dose of 30 mg/m2 twice daily (the maximum tolerated dose for monotherapy) as patients with normal renal function (CrCl >80 ml/min) had an increase in mean 5-FU AUC0-inf relative to that of the normal patients.
Danish: I et fase I-forsøg med Teysuno som monoterapi, der undersøgte farmakokinetikken af komponenter og metabolitter hos patienter med normal og nedsat nyrefunktion, havde patienter med mildt nedsat nyrefunktion (CrCl 51 til 80 ml/min.
English: b incl corneal epithelium defect, corneal erosion, corneal lesion, corneal opacity, corneal perforation, keratitis, punctate keratitis, ulcerative keratitis, limbal stem cell deficiency, visual acuity reduced, visual impairment, vision blurred.
Danish: defekt i corneale epithelium, corneaerosion, cornealæsion, corneaopacitet, corneaperforation, keratitis, keratitis punctata, ulcerativ keratitis, limbal stamcelle-mangel, nedsat visuel skarphed, synsforringelse, sløret syn.
English: Vision disorder, lacrimal disorder, conjunctivitis, corneal disorder b
Danish: Synsforstyrrelse, tårevejslidelser, konjunktivitis, øjensygdom, corneasygdom b
English: the median Tmax for Teysuno components tegafur, gimeracil, and oteracil was 0.5, 1.0, and 2.0 hours, respectively, and the mean ± standard deviation (SD) AUC0-inf and Cmax was 14595 ± 4340 ng.hr/ml and 1762 ± 279 ng/ml for tegafur, 1884 ± 640 ng.hr/ml and 452 ± 102 ng/ml for gimeracil, 556 ± 281 ng.hr/ml and 112 ± 52 ng/ml for oteracil.
Danish: Efter indgift af en enkeltdosis på 50 mg Teysuno (udtrykt som tegafurindhold) hos mennesker (ca. 30 mg/m2 baseret på en legemsoverflade på 1,56 til 2,10 m2 for den typiske patient, N=14) var den mediane Tmaks for Teysuno-komponenterne tegafur, gimeracil og oteracil hhv. 0,5, 1,0 og 2,0 timer, den gennemsnitlige ± standardafvigelse (SD) AUC0-inf og Cmaks var 14595 ± 4340 ng.t/ml og 1762 ± 279 ng/ml for tegafur, 1884 ± 640 ng.t/ml og 452 ± 102 ng/ml for gimeracil, 556 ± 281 ng.t/ml og 112 ± 52 ng/ml for oteracil.
English: Uncommon side effects (may affect 1 to 10 in 1,000 people) include:
Danish: Ikke almindelige bivirkninger (kan forekomme hos 1 til 10 ud af 1.000 personer) omfatter:
English: Refer to the cisplatin summary of product characteristics (SmPC) for pretreatment hyperhydration.
Danish: Der henvises til produktresuméet for cisplatin vedrørende forhydrering inden behandling.
English: What Teysuno is and what it is used for What you need to know before you take Teysuno How to take Teysuno
Danish: Det skal du vide, før du begynder at tage Teysuno Sådan skal du tage Teysuno Bivirkninger
English: Cerebrovascular accident, cerebellar infarction, cerebrovascular disorder, convulsion, ischaemic stroke, syncope, hemiparesis, aphasia, ataxia, metabolic encephalopathy, loss of consciousness, acoustic neuritis, memory impairment, balance disorder, somnolence, tremor, ageusia, parosmia, burning sensation, formication
Danish: Hjerneblødning, hjerneinfarkt, hjernelidelse, krampeanfald, iskæmisk slagtilfælde, synkope, hemiparese, afasi, ataksi, metabolisk encefalopati, bevidsthedstab, neuritis n. acusticus, nedsat hukommelse, balancesyge, somnolens, tremor, ageusi, parosmi, brændende fornemmelse, myrekryben
English: Nordic Group B.V. Siriusdreef 41
Danish: Nordic Group B.V.
English: Metastatic disease, n (%) ≥2 metastatic sites
Danish: Lokalisation af primær læsion, n (%) Vemtriklen Overgangen mellem ventrikel og oesophagus Begge Metastatisk sygdom, n (%) ≥2 metastatiske steder
English: The capsule has an opaque white body and opaque brown cap imprinted “TC448” in grey.
Danish: Kapslen består af en uigennemsigtig, hvid kapselende og en uigennemsigtig, brun kapselende med “TC448” præget i gråt.
English: Toxic nephropathy, oligouria, haematuria, renal impairment, pollakiuria, blood creatine increased, blood creatinine decreased
Danish: Toksisk nefropati, oliguri, hæmaturi, nedsat nyrefunktion, pollakisuri, øget blodcreatinin, reduceret blodcreatinin
English: o If you experience any of the above-mentioned symptoms, try not to work too hard and get ample sleep and rest. - Low white blood cell count leading to increased risk of severe local (e.g.,oral, lung, urine) or blood infections o You may have symptoms such as fever, chills, coughing, sore throat.
Danish: - Lavt antal hvide blodlegemer, der medfører øget risiko for alvorlig lokal infektion (f.eks. i munden, lungerne eller urinen) eller blodinfektion o Du kan få symptomer såsom feber, kulderystelser, hoste, ondt i halsen.
English: During and up to 6 months after treatment with Teysuno, you must use contraceptive measures.
Danish: Du skal bruge prævention under behandlingen med Teysuno og op til 6 måneder efter behandlingen.
English: Teysuno 20 mg/5.8 mg/15.8 mg hard capsules tegafur/gimeracil/oteracil
Danish: Teysuno 20 mg/5,8 mg/15,8 mg hårde kapsler tegafur/gimeracil/oteracil
English: Gastrointestinal perforation, oesophagitis, gastrointestinal infection, ileus, gastrointestinal obstruction, ascites, lip oedema, oesophageal spasm, gastric ulcer, gastroesophageal reflux disease, reflux gastritis, retroperitoneal fibrosis, gastrointestinal disorder, anal haemorrhage, haemorrhoids, salivary hypersecretion, retching, salivary gland disorder, cheilitis, aerophagia, eructation, glossodynia, oral pain, teeth brittle
Danish: Gastrointestinal perforation, oesophagitis, gastrointestinal infektion, ileus, gastrointestinal obstruktion, ascites, læbeødem, øsofageal spasme, mavesår, gastroøsofageal reflukssygdom, refluks gastritis, retroperitoneal fibrose, mave-tarmlidelser, anal blødning, haemorroider, hypersekretion af spyt, kløgning, spytkirtellidelser, cheilitis, aerofagi, opstød, glossalgi, mundsmerter, skøre tænder
English: Teysuno 15 mg/4.35 mg/11.8 mg hard capsules tegafur/gimeracil/oteracil
Danish: Teysuno 15 mg/4,35 mg/11,8 mg hårde kapsler tegafur/gimeracil/oteracil
English: Each hard capsule contains 20 mg tegafur, 5.8 mg gimeracil, and 15.8 mg oteracil (as monopotassium).
Danish: Hver hård kapsel indeholder 20 mg tegafur, 5,8 mg gimeracil og 15,8 mg oteracil (som monokalium).
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 15 mg tegafur, 4.35 mg gimeracil and 11.8 mg oteracil (as monopotassium).
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver hård kapsel indeholder 15 mg tegafur, 4,35 mg gimeracil og 11,8 mg oteracil (som monokalium).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains 20 mg tegafur, 5.8 mg gimeracil and 15.8 mg oteracil (as salt).
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver hård kapsel indeholder 20 mg tegafur, 5,8 mg gimeracil og 15,8 mg oteracil (som salt).
English: Teysuno belongs to the fluoropyrimidine class of medicine known as “antineoplastic agents” which stop the growth of cancer cells.
Danish: Teysuno er et fluoropyrimidin, en lægemiddelklasse der hedder ”antineoplastiske midler”.
English: Platelets Haemoglobin Teysuno dose modification
Danish: Hæmoglobin Dosisændring af Teysuno
English: Each hard capsule contains 15 mg tegafur, 4.35 mg gimeracil, and 11.8 mg oteracil (as monopotassium).
Danish: Hver hård kapsel indeholder 15 mg tegafur, 4,35 mg gimeracil og 11,8 mg oteracil (som monokalium).
English: Mucosal inflammation, pyrexia, weight decreased, peripheral oedema, chills
Danish: Vægttab, pyreksi, inflammation af slimhinder, perifert ødem, kulderystelser
English: Pulmonary embolism, respiratory tract haemorrhage, exertional dyspnoea, pharyngolaryngeal pain, rhinorrhoea, pharyngeal erythema, rhinitis allergic, dysphonia, productive cough, nasal congestion
Danish: Lungeemboli, blødning i luftvejene, anstrengelsesdyspnø, smerter i pharynx/larynx, næseflåd, erytem af pharynx, allergisk rhinitis, dysfoni, produktiv hoste, stoppet næse
English: Capsule contents: lactose monohydrate, magnesium stearate Capsule shell: gelatin, red iron oxide (E172), titanium dioxide (E171), sodium lauryl sulphate, talc
Danish: Kapselindhold: Lactosemonohydrat, magnesiumstearat Kapselskaller: Gelatine, titandioxid (E 171), natriumlaurylsulphat, talkum Tryk: Rød jernoxid (E172), gul jernoxid (E172), Indigocarmin (E 132), carnaubavoks, bleget shellac, glyceryl monooleat
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains 15 mg tegafur, 4.35 mg gimeracil and 11.8 mg oteracil (as salt).
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver hård kapsel indeholder 15 mg tegafur, 4,35 mg gimeracil og 11,8 mg oteracil (som salt).
English: CrCl must be calculated at the beginning of every cycle before the start of treatment with Teysuno on Day 1.
Danish: Neutrofile ≥ 1,5 x 109/l Hæmoglobin ≥ 6,2 mmol/l CrCl skal beregnes ved starten af hvert behandlingsforløb, inden behandling med Teysuno indledes på dag 1.
English: If you experience any of the side effects or if you notice any side effects not listed in this leaflet, please tell your doctor.
Danish: Tal med lægen, hvis du får nogle af bivirkningerne, eller du får bivirkninger, som ikke er nævnt her.
English: No data are available on the concomitant use of nitromidazoles with Teysuno in combination with cisplatin.
Danish: Der foreligger ingen data om samtidig brug af nitromidazoler med Teysuno i kombination med cisplatin.
English: Iliac artery thrombosis, hypovolaemic shock, arterial limb thrombosis, thrombosis, flushing, pelvic venous thrombosis, thrombophlebitis, phlebitis, phlebitis superficial, orthostatic hypotension, haematoma, hyperaemia, hot flush
Danish: Trombose i a. iliaca, hypovolæmisk shock, arterietrombose i ekstremitet, trombose, blussen, venetrombose i pelvis, tromboflebitis, flebitis, årebetændelse, ortostatisk hypotension, hæmatom, hyperæmi, hedeture
English: either 42 capsules or 84 capsules.
Danish: Hver pakning indeholder enten 42 kapsler eller 84 kapsler.
English: - This medicine has been prescribed for you.
Danish: - Lægen har ordineret Teysuno til dig personligt.
English: NAME OF THE MEDICINAL PRODUCT Teysuno 15 mg/4.35 mg/11.8 mg hard capsules tegafur/gimeracil/oteracil
Danish: LÆGEMIDLETS NAVN Teysuno 15 mg/4,35 mg/11,8 mg hårde kapsler Tegafur/gimeracil/oteracil
English: The capsule has an opaque white body and opaque white cap imprinted “TC442” in grey.
Danish: Kapslen består af en uigennemsigtig, hvis kapselende og en uigennemsigtig, hvid kapselende med “TC442” præget i gråt.
English: No data are available on the concomitant use of methotrexate with Teysuno in combination with cisplatin.
Danish: Der foreligger ingen data om samtidig brug af methotrexat med Teysuno i kombination med cisplatin.
English: No data are available on the concomitant use of cimetidine with Teysuno in combination with cisplatin.
Danish: Der foreligger ingen data om samtidig brug af cimetidin med Teysuno i kombination med cisplatin.
English: Comparison of 218 patients with mild renal impairment at baseline (CrCl 51 to 80 ml/min) to 297 patients with normal renal function at baseline (CrCl >80 ml/min) treated with Teysuno in combination with cisplatin in the FLAGS study indicated that there were no clinically significant differences in safety between patients with mild renal impairment and patients with normal renal function.
Danish: En sammenligning af 218 patienter med let nedsat nyrefunktion ved baseline (CrCl 51 til 80 ml/min.)
English: Muscle spasms, arthralgia, pain in extremity, back pain, neck pain, bone pain, joint swelling, limb discomfort, muscle tightness, muscular weakness
Danish: Muskelspasmer, artralgi, smerter i ekstremitet, rygsmerter, nakkesmerter, knoglesmerter, hævede led, ubehag i ekstremitet, muskelstramhed, muskelsvækkelse
English: NAME OF THE MEDICINAL PRODUCT Teysuno 20 mg/5.8 mg/15.8 mg hard capsules tegafur/gimeracil/oteracil
Danish: LÆGEMIDLETS NAVN Teysuno 20 mg/5,8 mg/15,8 mg hårde kapsler Tegafur/gimeracil/oteracil
English: o To help manage nausea and vomiting: ▪ Lie down or take deep breaths when feeling nauseous ▪ Avoid tight clothing - Low red blood cell count leading to anaemia o You may have symptoms such as cold hands and feet, looking pale, light-headedness, fatigue, breathlessness.
Danish: o Sådan kan du forebygge kvalme og opkastning: ▪ Læg dig ned eller træk vejret dybt, hvis du får kvalme ▪ Undgå stramt tøj
English: Tel: +39 (0)2 241 26710/26711 info@nordicpharma.it
Danish: Nordic Pharma Tel: +39 (0)2 753 2629 info@nordicpharma.it
English: No data are available on the concomitant use of folinic acid with Teysuno in combination with cisplatin.
Danish: Der foreligger ingen data om samtidig brug af folinsyre med Teysuno i kombination med cisplatin.
English: Dose modifications should be applied for the precipitating adverse reaction as necessary (see section 4.2).
Danish: Dosisændringer skal foretages efter behov og efter de opstillede kriterier og i forhold til den/de udløsende årsager til bivirkninger efter behov (se pkt.
English: Gimeracil is primarily cleared by the kidney (see section 5.2); so, in patients with renal insufficiency gimeracil renal clearance is decreased and 5-FU exposure thus increased.
Danish: Hos patienter med nedsat nyrefunktion er den renale udskillelse af gimeracil derfor nedsat, og eksponeringen for 5-FU er øget.
English: No data are available on the concomitant use of clozapine with Teysuno in combination with cisplatin.
Danish: Der foreligger ingen data om samtidig brug af clozapin med Teysuno i kombination med cisplatin.
English: To detect early changes in renal function during treatment, renal parameters should be closely monitored (e.g., serum creatinine, CrCl).
Danish: Nyreparametre (f.eks. serum-creatinin, CrCl) bør kontrolleres ofte for at registrere tidlige ændringer i nyrefunktionen under behandlingen.
English: 126 capsules
Danish: 42 kapsler 84 kapsler 126 kapsler
English: • Mild renal impairment (CrCl 51 to 80 ml/min) No adjustment of the standard dose is recommended in patients with mild renal impairment (see section 5.2).
Danish: • Let nedsat nyrefunktion (CrCl 51-80 ml/min.)
English: Teysuno dose calculations
Danish: Beregninger af Teysuno-doser
English: NAME OF THE MEDICINAL PRODUCT Teysuno 20 mg/5.8 mg/15.8 mg capsules tegafur/gimeracil/oteracil
Danish: LÆGEMIDLETS NAVN Teysuno 20 mg/5,8 mg/15,8 mg kapsler tegafurum/gimeracilum/oteracilum NAVN INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Nordic Group B.V.
English: NAME OF THE MEDICINAL PRODUCT Teysuno 15 mg/4.35 mg/11.8 mg capsules tegafur/gimeracil/oteracil
Danish: LÆGEMIDLETS NAVN Teysuno 15 mg/4,35 mg/11,8 mg kapsler tegafurum/gimeracilum/oteracilum NAVN INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Nordic Group B.V.
English: White
Danish: Andre
English: - Nerve: headache, dizziness, sleeplessness, changes in taste - Eye: eye problems, increased or decreased tearing discomfort, vision problems, serious illness with blistering of the eyes, wearing away of the surface “skin” of the eye (corneal erosion) - Ear: hearing problems - Blood vessels: high or low blood pressure, blood clots in the leg and lung
Danish: - Ører: Høreproblemer - Blodkar: Højt eller lavt blodtryk, blodpropper i benene og lungerne - Lunger og næsepassage: Kortåndethed, hoste - Mave og mund: Mundtørhed, sår i mund, hals og spiserør, hikke, mavesmerter, mavebesvær,
English: months
Danish: Øjne
English: Adrenal haemorrhage
Danish: Mave-tarmkanalen
English: • Severe renal impairment (CrCl below 30 ml/min) Although roughly similar daily exposure to 5-FU would be expected in patients with severe renal impairment at a dose of 20 mg/m2 once daily compared to 30 mg/m2 twice daily in patients with normal renal function (see section 5.2), administration of Teysuno is not recommended due to possibly higher incidence of adverse events of the blood and lymphatic system disorders unless the benefits clearly outweigh the risks (see sections 4.4 and 4.8).
Danish: Selvom der kan forventes stort set samme daglige eksponering for fluoruracil (5-FU) hos patienter med svært nedsat nyrefunktion ved en dosis på 20 mg/m2 én gang dagligt sammenlignet med 30 mg/m2 to gange dagligt hos patienter med normal nyrefunktion (se pkt.
English: These measures will help to protect the environment.
Danish: Dette vil være medvirkende til at beskytte miljøet.
English: Redose with same strength.
Danish: Dosér igen med samme styrke.
English: Not known (frequency cannot be estimated from the available data):
Danish: Hyppighed ikke kendt (hyppigheden kan ikke estimeres ud fra forhåndenværende data):
English: These side effects can be very serious.
Danish: Disse bivirkninger kan være meget alvorlige.
English: The batteries cannot be replaced.
Danish: Batterierne kan ikke udskiftes.
English: Your doctor will tell you whether Instanyl is suitable for you.
Danish: Din læge vil fortælle dig, om Instanyl er egnet til dig.
English: Shows how much time is left of the locking period.
Danish: Viser, hvor lang tid der er tilbage af låsningsperioden.
English: The corresponding median Tmax are 12-15 minutes.
Danish: Den tilsvarende medianværdi for Tmax er 12-15 minutter.
English: - Use one dose of Instanyl - Wait 10 minutes
Danish: - Tag en dosis Instanyl - Vent 10 minutter
English: Symbols in the electronic display
Danish: Symboler i det elektroniske display
English: Symptoms of overdose are:
Danish: Symptomer på overdosering er:
English: Ask your pharmacist.
Danish: Spørg på apoteket.
English: This may reduce the efficacy of Instanyl.
Danish: Dette kan reducere effekten af Instanyl.
English: • Keep your head upright
Danish: • Hold dit hoved opret
English: Patients must be carefully monitored during the titration process.
Danish: Patienterne bør monitoreres omhyggeligt under titreringsprocessen.
English: This should clear any blockage.
Danish: Det skulle fjerne en eventuel blokering.
English: The half-life of the antagonist may be short, therefore repeated administration or continuous infusion may be necessary.
Danish: Halveringstiden af antagonisten kan være kort, og derfor kan gentagen administration eller kontinuerlig infusion være nødvendigt.
English: The absolute bioavailability of Instanyl is approximately 89.
Danish: Den absolutte biotilgængelighed for Instanyl er cirka 89 %.
English: Start at 50 micrograms
Danish: Start med 50 mikrogram
English: This instrument is labelled in accordance with the EU Waste Electrical and Electronic Equipment Directive (WEEE).
Danish: Denne beholder er mærket i henhold til Europa-Parlamentets og Rådets direktiv om affald af elektrisk og elektronisk udstyr (WEEE).
English: It does not matter which nostril you use.
Danish: Det har ingen betydning, hvilket næsebor du vælger.
English: Try to keep the person awake until emergency help arrives.
Danish: Prøv at holde personen vågen, indtil hjælpen når frem.
English: There are no human data on fertility available.
Danish: Der er ingen tilgængelige humane fertilitetsdata.
English: Children and adolescents Instanyl should not be used in children and adolescents under 18 years of age.
Danish: Børn og unge Instanyl må ikke anvendes til børn og unge under 18 år.
English: Please consider to contact the physician for discussion.
Danish: Overvej at kontakte lægen for en diskussion.
English: Teratogenic effects have not been demonstrated.
Danish: Der er ikke påvist teratogene virkninger.
English: Instanyl should not be used during pregnancy unless you have discussed this with your doctor.
Danish: Instanyl bør ikke anvendes under graviditet, medmindre du har aftalt det med din læge.
English: Instanyl can be harmful to other people, especially children.
Danish: Instanyl kan skade andre personer, specielt børn.
English: Once the dose has been established according to the steps described above, the patient should be maintained on this strength of Instanyl.
Danish: Når dosis er blevet fastlagt i henhold til de ovenfor beskrevne trin, bør patienten fastholdes på denne styrke af Instanyl.
English: The primary therapeutic action is analgesia.
Danish: Den primære terapeutiske virkning er analgestisk.
English: Common (may affect up to 1 in 10 people):
Danish: Almindelige bivirkninger (kan påvirke op til 1 ud af 10 personer):
English: The following categories are used to rank the undesirable effects by frequency of occurrence: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1000 to < 1/100); rare (≥ 1/10,000 to < 1/1000); and very rare (< 1/10,000), not known (cannot be estimated from the available data).
Danish: Følgende klassificering er brugt til at placere bivirkningerne efter frekvens: Meget almindelig (≥ 1/10); almindelig (≥ 1/100 til < 1/10); ikke almindelig (≥ 1/1.000 til < 1/100); sjælden (≥ 1/10.000 til < 1/1000) og meget sjælden (< 1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Patients in the second pivotal study had earlier participated in the Instanyl pharmacokinetic study or in the first pivotal study.
Danish: Patienterne i det andet pivotale studie havde tidligere deltaget i farmakokinetikstudiet af Instanyl eller i det første pivotal studie.
English: Each titration step (dose strength) should be evaluated in several episodes.
Danish: Hvert titreringstrin (dosis styrke) bør evalueres over flere episoder.
English: You should sit or stand in upright position.
Danish: Du skal sidde eller stå i oprejst position.
English: Change in dose must be done together with your doctor.
Danish: Ændring i dosering skal foretages i samråd med din læge.
English: This is because it may then give you the wrong dose.
Danish: Det kan forårsage, at du får den forkerte dosis.
English: Therefore:
Danish: Derfor:
English: Dose increase should be done with caution.
Danish: Dosisforøgelser bør foretages med forsigtighed.
English: - have a rattling sound when you breathe in. - have convulsive pain.
Danish: - har en rallende lyd, når du trækker vejret ind. - har krampeagtige smerter.
English: The elimination half-life is approximately 3-4 hours for Instanyl in cancer patients.
Danish: Eliminationshalveringstiden er cirka 3-4 timer for Instanyl hos cancerpatienter.
English: Bend your head slightly forward.
Danish: Bøj hovedet let forover.
English: Consider next higher strength for next episode
Danish: Overvej efterfølgende højere styrke til behandling af næste episode.