FrancophonIA/ELRC3.0 huggingface dataset:
English: You should not use Sildenafil Teva with treatments for pulmonary arterial hypertension (PAH) containing sildenafil or any other PDE5 inhibitors.
Danish: Du bør ikke tage Sildenafil Teva, hvis du samtidig bliver behandlet for pulmonal arteriel hypertension (PAH) med et lægemiddel, der indeholder sildenafil, eller hvis du samtidig får en anden PDE5hæmmer.
English: Film coat: poly(vinyl alcohol), titanium dioxide (E171), macrogol 3350, talc.
Danish: croscarmellosenatrium, magnesiumstearat Filmovertræk: Poly(vinylalkohol), titandioxid (E171), macrogol 3350, talkum.
English: Cerebrovascular accident, Transient ischaemic attack, Seizure,* Seizure recurrence,* Syncope
Danish: Cerebrovaskulær hændelse, transitorisk iskæmisk attak, krampeanfald*, tilbagevendende krampeanfald*, synkope
English: The most commonly reported adverse reactions in clinical studies among sildenafil treated patients were headache, flushing, dyspepsia, nasal congestion, dizziness, nausea, hot flush, visual disturbance, cyanopsia and.
Danish: De hyppigst rapporterede bivirkninger i kliniske studier hos sildenafilbehandlede patienter var hovedpine, ansigtsrødme, dyspepsi, næsetilstopning, svimmelhed, kvalme, hedeture, synsforstyrrelser, cyanopsi (blåsyn) og sløret syn.
English: The safety and efficacy of combinations of sildenafil with other PDE5 Inhibitors, or other pulmonary arterial hypertension (PAH) treatments containing sildenafil , or other treatments for erectile dysfunction have not been studied.
Danish: Sikkerhed og effekt er ikke undersøgt ved samtidig brug af sildenafil og andre PDE5-hæmmere eller andre behandlinger af erektil dysfunktion eller ved samtidig sildenafil-behandling af pulmunal arteriel hypertension (PAH).
English: How to take Sildenafil Teva
Danish: Sådan skal du tage Sildenafil Teva
English: Uncommon (≥ 1/1,000 and
Danish: (≥ 1/1.000 og
English: In volunteers with severe renal impairment (creatinine clearance <30 mL/min), sildenafil clearance was reduced, resulting in mean increases in AUC and Cmax of 100 % and 88 % respectively compared to age-matched volunteers with no renal impairment.
Danish: Hos frivillige forsøgspersoner med svært nedsat nyrefunktion (kreatininclearance < 30 ml/min) reduceres sildenafil-clearance, hvilket fører til gennemsnitlige stigninger i AUC og Cmax på henholdsvis 100 % og 88 % sammenlignet med forsøgspersoner i samme alderskategori uden nedsat nyrefunktion.
English: Contents of the pack and other information What Sildenafil Teva contains
Danish: Pakningsstørrelser og yderligere oplysninger Sildenafil Teva indeholder:
English: Sildenafil Teva is available in blister packs of 2, 4, 8 and 12 tablets, and perforated unit dose blisters containing 10 x 1 tablet.
Danish: Sildenafil Teva findes i blisterpakninger med 2, 4, 8 og 12 tabletter og perforerede enhedsdosisblistere indeholdende 10 x 1 tablet.
English: Sildenafil Teva is available in blister packs of 2, 4, 8, 12 and 24 tablets, and perforated unit dose blisters containing 10 x 1 tablet.
Danish: Sildenafil Teva findes i blisterpakninger med 2, 4, 8, 12 og 24 tabletter og perforerede enhedsdosisblistere indeholdende 10 x 1 tablet.
English: Penile haemorrhage, Priapism,* Haematospermia , Erection increased
Danish: Blødning fra penis, priapisme*, hæmatospermi, forlænget erektion
English: In normal healthy male volunteers, there was no evidence of an effect of azithromycin (500 mg daily for 3 days) on the AUC, Cmax, tmax, elimination rate constant, or subsequent half-life of sildenafil or its principal circulating metabolite.
Danish: (500 mg dagligt i 3 dage) ingen tegn på ændringer af AUC, Cmax, tmax, eliminationshastighedskonstanten eller efterfølgende halveringstid for sildenafil eller dets væsentligste cirkulerende metabolit.
English: Myocardial infarction, Ventricular arrhythmia,* Atrial fibrillation, Unstable angina
Danish: Pludselig hjertedød*, myokardieinfarkt, ventrikulær arytmi*, atrieflimren, ustabil angina
English: • Seizures or fits - this occurs rarely
Danish: • Kramper eller krampeanfald - dette ses sjældent.
English: You should not take Sildenafil Teva if you are using any of the medicines known as nitric oxide donors such as amyl nitrite (“poppers”) as the combination may also lead to a dangerous fall in your blood pressure.
Danish: Du må ikke tage Sildenafil Teva, hvis du tager medicin, som kaldes nitrogenoxiddonorer som f.eks. amylnitrit (“poppers”), da kombinationen også kan medføre potentielt farligt blodtryksfald.
English: Use in adults
Danish: Voksne
English: You should not take Sildenafil Teva if you are taking medicines called nitrates, as the combination of these medicines may lead to a dangerous fall in your blood pressure.
Danish: Du må ikke tage Sildenafil Teva, hvis du tager medicin, som kaldes nitrater, da kombinationen af disse kan medføre potentielt farligt blodtryksfald.
English: However, you may find that Sildenafil Teva takes longer to start working if you take it with a heavy meal.
Danish: Du kan måske opleve, at det kan tage lidt længere tid før Sildenafil Teva virker, hvis du har spist et tungt måltid.
English: When a single 100 mg dose of sildenafil was administered with erythromycin, a moderate CYP3A4 inhibitor, at steady state (500 mg twice daily for 5 days), there was a 182 % increase in sildenafil systemic exposure (AUC).
Danish: Ved indgift af en enkeltdosis sildenafil 100 mg sammen med erythromycin, en moderat CYP3A4hæmmer, i steady state (500 mg 2 gange dagligt i 5 dage) sås en 182 % stigning i optagelsen af sildenafil (AUC).
English: Sildenafil Teva 100 mg film-coated tablets EU/1/09/584/014
Danish: Sildenafil Teva 100 mg filmovertrukne tabletter EU/1/09/584/014
English: *Reported during post-marketing surveillance only **Visual colour distortions: Chloropsia, Chromatopsia, Cyanopsia, Erythropsia and Xanthopsia ***Lacrimation disorders: Dry eye, Lacrimal disorder and Lacrimation increased
Danish: ** Synsfarveforvrængning: chloropsi, kromatopsi, cyanopsi, erythropsi og xanthopsi *** Forstyrrelser i tåredannelsen: tørre øjne, forstyrrelser i tåreproduktionen og tåreflåd
English: The total body clearance of sildenafil is 41 L/h with a resultant terminal phase half-life of 3-5 h. After either oral or intravenous administration, sildenafil is excreted as metabolites predominantly in the faeces (approximately 80 % of administered oral dose) and to a lesser extent in the urine (approximately 13 % of administered oral dose).
Danish: Efter enten oral eller intravenøs indgift udskilles sildenafil som metabolitter hovedsageligt i faeces (ca. 80 % af indgivet oral dosis) og i mindre grad i urinen (ca. 13 % af indgivet oral dosis).
English: Always take this medicine exactly as your doctor or pharmacist has told you.
Danish: Tag altid Sildenafil Teva nøjagtigt efter lægens eller apotekspersonalets anvisning.
English: Common (≥ 1/100 and
Danish: (≥ 1/100 og <1/10)
English: Sildenafil Teva 50 mg film-coated tablets EU/1/09/584/008
Danish: Sildenafil Teva 50 mg filmovertrukne tabletter EU/1/09/584/008
English: A double-blind, placebo-controlled exercise stress trial evaluated 144 patients with erectile dysfunction and chronic stable angina who regularly received anti-anginal medicinal products (except nitrates).
Danish: I et dobbelt-blind, placebo-kontrolleret motionsstressstudie, hvori 144 patienter med erektil dysfunktion og stabil angina tog deres sædvanlige medicin mod angina pectoris (undtaget nitrater), blev der ikke set klinisk relevante forskelle i tiden indtil angina blev en begrænsende faktor for sildenafil sammenlignet med placebo.
English: Sildenafil Teva 25 mg film-coated tablets EU/1/09/584/002
Danish: Sildenafil Teva 25 mg filmovertrukne tabletter EU/1/09/584/002
English: Cimetidine (800 mg), a cytochrome P450 inhibitor and non-specific CYP3A4 inhibitor, caused a 56 % increase in plasma sildenafil concentrations when co-administered with sildenafil (50 mg) to healthy volunteers.
Danish: Hos raske frivillige forsøgspersoner gav cimetidin (800 mg), en cytokrom P450-hæmmer og ikke specifik CYP3A4-hæmmer en 56 % stigning i plasmakoncentrationer af sildenafil ved indgift sammen med sildenafil (50 mg).
English: − If you are using any of the medicines known as nitric oxide donors such as amyl nitrite (“poppers”), as the combination may also lead to a dangerous fall in your blood pressure.
Danish: Hvis du bruger præparater, som kaldes nitrogenoxiddonorer som amylnitrit (“poppers”), da samtidig brug også kan medføre potentielt farligt blodtryksfald.
English: Since sildenafil clearance is reduced in patients with severe renal impairment (creatinine clearance <30 mL/min) a 25 mg dose should be considered.
Danish: Da sildenafilclearance er nedsat hos patienter med alvorligt nedsat nyrefunktion (kreatininclearance <30 ml/min.)
English: Co-administration of the HIV protease inhibitor ritonavir, which is a highly potent P450 inhibitor, at steady state (500 mg twice daily) with sildenafil (100 mg single dose) resulted in a 300 % (4-fold) increase in sildenafil Cmax and a 1,000 % (11-fold) increase in sildenafil plasma AUC.
Danish: Samtidig indgift med HIV-proteasehæmmeren, ritonavir, som er en meget potent P450-hæmmer, ved steady state (500 mg 2 gange dagligt) og enkeltdosis af sildenafil (100 mg) gav en stigning i sildenafils Cmax på 300 % (4 gange) og en stigning i sildenafils plasma AUC på 1.000 % (11 gange).
English: Sildenafil Teva 25 mg film-coated tablets Sildenafil Teva 50 mg film-coated tablets Sildenafil Teva 100 mg film-coated tablets
Danish: Sildenafil Teva 25 mg filmovertrukne tabletter Sildenafil Teva 50 mg filmovertrukne tabletter Sildenafil Teva 100 mg filmovertrukne tabletter
English: Sildenafil Teva is contraindicated in patients who have loss of vision in one eye because of nonarteritic anterior ischaemic optic neuropathy (NAION), regardless of whether this episode was in connection or not with previous PDE5 inhibitor exposure (see section 4.4).
Danish: Sildenafil Teva er kontraindiceret til patienter, som på grund af non-arteritis anterior iskæmisk opticusneuropati (NAION) har nedsættelse af synet på det ene øje.
English: Serious cardiovascular events, including myocardial infarction, unstable angina, sudden cardiac death, ventricular arrhythmia, cerebrovascular haemorrhage, transient ischaemic attack, hypertension and hypotension have been reported post-marketing in temporal association with the use of sildenafil.
Danish: Efter markedsføringen er der i forbindelse med brugen af sildenafil rapporteret alvorlige kardiovaskulære hændelser, inklusive myokardieinfarkt, ustabil angina pectoris, pludselig hjertedød, ventrikulær arytmi, cerebrovaskulær blødning, transitorisk cerebral iskæmi, hypertension og hypotension.
English: − If you have sickle cell anaemia (an abnormality of red blood cells), leukaemia (cancer of blood cells), multiple myeloma (cancer of bone marrow)
Danish: Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før du tager Sildenafil Teva Hvis du har en abnormitet af de røde blodlegemer (seglcelleanæmi), blodkræft (leukæmi), knoglemarvskræft (multipelt myelom )
English: − If you are taking medicines called nitrates, as the combination may lead to a dangerous fall in your blood pressure.
Danish: Hvis du tager medicin, som kaldes nitrater, da samtidig brug kan medføre potentielt farligt blodtryksfald.
English: Tablet core: microcrystalline cellulose, calcium hydrogen phosphate anhydrous, croscarmellose sodium, magnesium stearate.
Danish: Tabletkerne: Mikrokrystallinsk cellulose, calciumhydrogenphosphat (vandfrit),
English: Co-administration of the HIV protease inhibitor saquinavir, a CYP3A4 inhibitor, at steady state (1200 mg three times a day) with sildenafil (100 mg single dose) resulted in a 140 % increase in sildenafil Cmax and a 210 % increase in sildenafil AUC.
Danish: Samtidig indgift med HIV-proteasehæmmeren saquinavir, en CYP3A4-hæmmer, ved steady state (1.200 mg 3 gange dagligt) og enkeltdosis sildenafil (100 mg) gav en stigning i sildenafils Cmax på 140 % og en stigning i sildenafils plasma AUC på 210 %.
English: Sildenafil Teva 100 mg film-coated tablets PVC/Aluminium blisters in cartons of 2, 4, 8, 12 or 24 tablets.
Danish: Sildenafil Teva 100 mg filmovertrukne tabletter PVC/aluminiumblistere i kartoner med 2, 4, 8, 12 eller 24 tabletter.
English: Sildenafil Teva 25 mg film-coated tablets PVC/Aluminium blisters in cartons of 2, 4, 8 or 12 tablets.
Danish: Sildenafil Teva 25 mg filmovertrukne tabletter PVC/aluminiumblistere i kartoner med 2, 4, 8 eller 12 tabletter.
English: Sildenafil Teva 50 mg film-coated tablets PVC/Aluminium blisters in cartons of 2, 4, 8, 12 or 24 tablets.
Danish: Sildenafil Teva 50 mg filmovertrukne tabletter PVC/aluminiumblistere i kartoner med 2, 4, 8, 12 eller 24 tabletter.
English: Common (may affect up to 1 in 10 people): nausea, facial flushing, hot flush (symptoms include a sudden feeling of heat in your upper body), indigestion, colour tinge to vision, blurred vision, visual disturbance, stuffy nose and dizziness.
Danish: Almindelig (kan ses hos op til 1 ud af 10personer): kvalme, ansigtsrødme, hedeture (symptomerne omfatter en pludselig varmefølelse i overkroppen), dårlig fordøjelse, farvesyn, sløret syn, synsforstyrrelser, tilstoppet næse og svimmelhed.
English: Non-arteritic anterior ischaemic optic neuropathy (NAION), * Retinal vascular occlusion,* Retinal haemorrhage, Arteriosclerotic retinopathy, Retinal disorder, Glaucoma, Visual field defect,
Danish: Non-arteritis anterior iskæmisk opticusneuropati (NAION)*, vaskulær okklusion i retina*, blødning i retina, arteriosklerotisk retinopati, retinal sygdom, glaukom, synsfeltdefekt, diplopi, nedsat synsskarphed, myopi, astenopi, ”flyvende fluer”, sygdom i iris, mydriasis, farvet ring omkring lyskilder, øjenødem, hævede øjne, øjenlidelse,
English: What Sildenafil Teva is and what it is used for What you need to know before you take Sildenafil Teva How to take Sildenafil Teva Possible side effects
Danish: Det skal du vide, før du begynder at tage Sildenafil Teva Sådan skal du tage Sildenafil Teva Bivirkninger
English: Each tablet contains 25 mg of sildenafil (as the citrate salt).
Danish: Hver tablet indeholder 25 mg sildenafil (som citratsalt).
English: White, oval-shaped film-coated tablets, engraved with ‘S 25' on one side, and plain on the other side.
Danish: Hvide, ovale filmovertrukne tabletter, mærket med "S 25" på den ene side og uden mærkning på den anden side.
English: Sildenafil Teva 100 mg film-coated tablets Each tablet contains sildenafil citrate equivalent to 100 mg of sildenafil.
Danish: Sildenafil Teva 100 mg filmovertrukne tabletter Hver tablet indeholder sildenafilcitrat svarende til 100 mg sildenafil.
English: If you are taking riociguat or are unsure, tell your doctor.
Danish: Tal med din læge hvis du tager riociguat eller er usikker.
English: Each tablet contains 100 mg of sildenafil (as the citrate salt).
Danish: Hver tablet indeholder 100 mg sildenafil (som citratsalt).
English: White, oval-shaped film-coated tablets, engraved with ‘S 100' on one side, and plain on the other side.
Danish: Hvide, ovale filmovertrukne tabletter, mærket med "S 100" på den ene side og uden mærkning på den anden side.
English: Sildenafil Teva 25 mg film-coated tablets Each tablet contains sildenafil citrate equivalent to 25 mg of sildenafil.
Danish: Sildenafil Teva 25 mg filmovertrukne tabletter Hver tablet indeholder sildenafilcitrat svarende til 25 mg sildenafil.
English: In order for Sildenafil Teva to be effective, sexual stimulation is required.
Danish: Seksuel stimulation er nødvendig, for at Sildenafil Teva kan virke.
English: Each tablet contains 50 mg of sildenafil (as the citrate salt).
Danish: Hver tablet indeholder 50 mg sildenafil (som citratsalt).
English: White, oval-shaped film-coated tablets, engraved with ‘S 50' on one side, and plain on the other side.
Danish: Hvide, ovale filmovertrukne tabletter, mærket med "S 50" på den ene side og uden mærkning på den anden side.
English: Sildenafil Teva 50 mg film-coated tablets Each tablet contains sildenafil citrate equivalent to 50 mg of sildenafil.
Danish: Sildenafil Teva 50 mg filmovertrukne tabletter Hver tablet indeholder sildenafilcitrat svarende til 50 mg sildenafil.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER - Sildenafil Teva 25 mg Film-coated tablets
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIPS BLISTER - Sildenafil Teva 25 mg filmovertrukne tabletter
English: Package leaflet: Information for the patient Sildenafil Teva 25 mg film-coated tablets
Danish: Indlægsseddel: Information til brugeren Sildenafil Teva 25 mg filmovertrukne tabletter
English: Package leaflet: Information for the patient Sildenafil Teva 100 mg film-coated tablets
Danish: Indlægsseddel: Information til brugeren Sildenafil Teva 100 mg filmovertrukne tabletter
English: To reduce the chance that these symptoms might happen, you should be on a regular daily dose of your alpha-blocker before you start Sildenafil Teva.
Danish: Du bør være på en regelmæssig daglig dosis af alfablokkeren, før du tager Sildenafil Teva, for at nedsætte risikoen for at disse symptomer opstår.
English: Each tablet contains sildenafil citrate equivalent to 25 mg of sildenafil
Danish: Hver tablet indeholder sildenafilcitrat svarende til 25 mg sildenafil.
English: If you take more Sildenafil Teva than you should:
Danish: Hvis du vil have yderligere oplysninger om Sildenafil Teva, skal du henvende dig til den lokale repræsentant:
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER - Sildenafil Teva 100 mg Film-coated tablets
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIPS BLISTER - Sildenafil Teva 100 mg filmovertrukne tabletter
English: Package leaflet: Information for the patient Sildenafil Teva 50 mg film-coated tablets
Danish: Indlægsseddel: Information til brugeren Sildenafil Teva 50 mg filmovertrukne tabletter
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER - Sildenafil Teva 50 mg Film-coated tablets
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIPS BLISTER - Sildenafil Teva 50 mg filmovertrukne tabletter
English: Sildenafil Teva is a treatment for adult men with erectile dysfunction, sometimes known as impotence.
Danish: Sildenafil Teva er til behandling af voksne mænd med erektil dysfunktion, af og til kendt som impotens, hvilket er manglende evne til at opnå og/eller opretholde erektion tilstrækkelig til at gennemføre tilfredsstillende seksuel aktivitet.
English: Deafness
Danish: Dosering
English: Sildenafil Teva 25 mg film-coated tablets sildenafil
Danish: Sildenafil Teva 25 mg filmovertrukne tabletter sildenafil
English: Sildenafil Teva 25 mg film-coated tablets
Danish: Sildenafil Teva 25 mg filmovertrukne tabletter
English: Each tablet contains sildenafil citrate equivalent to 100 mg of sildenafil
Danish: Hver tablet indeholder 100 mg sildenafilcitrat svarende til 100 mg sildenafil.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON - Sildenafil Teva 50 mg Film-coated tablets
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE ÆSKE - Sildenafil Teva 50 mg filmovertrukne tabletter
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON - Sildenafil Teva 100 mg Film-coated tablets
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE ÆSKE - Sildenafil Teva 100 mg filmovertrukne tabletter
English: Sildenafil Teva 100 mg film-coated tablets sildenafil
Danish: Sildenafil Teva 100 mg filmovertrukne tabletter sildenafil
English: Manufacturer:
Danish: Filmovertræk:
English: Pharmacotherapeutic group: Urologicals; Drugs used in erectile dysfunction.
Danish: Farmakoterapeutisk gruppe: Urogenitalsystem og kønshormoner: Systemiske midler til erektil dysfunktion., ATC-kode: G04B E03.
English: You should not take Sildenafil Teva if you are a woman.
Danish: Sildenafil Teva bør ikke anvendes af kvinder.
English: Each tablet contains sildenafil citrate equivalent to 50 mg of sildenafil
Danish: Hver tablet indeholder 50 mg sildenafilcitrat svarende til 50 mg sildenafil.
English: Sildenafil Teva 50 mg film-coated tablets sildenafil
Danish: Sildenafil Teva 50 mg filmovertrukne tabletter sildenafil
English: Sildenafil Teva 100 mg film-coated tablets
Danish: Sildenafil Teva 100 mg filmovertrukne tabletter
English: Sildenafil Teva 50 mg film-coated tablets
Danish: Sildenafil Teva 50 mg filmovertrukne tabletter
English: Halo vision, Eye oedema, Eye swelling, Eye disorder, Conjunctival hyperaemia, Eye irritation, Abnormal sensation in eye, Eyelid oedema, Scleral discoloration
Danish: Sjælden (≥ 1/10.000 og konjunktival hyperæmi, øjenirritation, unormal følelse i øjet, øjenlågsødem, tørre øjne, skleral misfarvning
English: If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Danish: Er du i tvivl, så spørg lægen eller på apoteket.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON - Sildenafil Teva 25 mg Film-coated tablets
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE ÆSKE- Sildenafil Teva 25 mg filmovertrukne tabletter
English: Film-coat
Danish: Mave-tarmkanalen
English: • An allergic reaction - this occurs uncommonly (may affect up to 1 in 100 people) Symptoms include sudden wheeziness, difficulty in breathing or dizziness, swelling of the eyelids, face, lips or throat.
Danish: Almindelig (kan ses hos op til 1 ud af 10 personer): kvalme, ansigtsrødme, hedeture (symptomerne omfatter en pludselig varmefølelse i overkroppen), dårlig fordøjelse, farvesyn, sløret syn, synsforstyrrelser, tilstoppet næse og svimmelhed.
English: o Gastrointestinal: diarrhea, bloody stool, abdominal pain, nausea, or vomiting o Liver: yellowing of your skin or whites of your eyes o Skin: rash, blisters and/or peeling, mouth sores o Eye: blurred vision, vision changes, eye pain, o General: fever, headache, feeling tired, dizziness or fainting, dark urine, bleeding, weakness, numbness of legs, arms, or faces, changes in behavior, such as less sex drive, being irritable or forgetful
Danish: o Mave-tarmkanalen: diarre, blodig afføring, mavesmerter, kvalme eller opkastning o Lever: gulfarvning af huden eller det hvide i øjnene o Hud: udslæt, blærer og/eller afskalning af huden, mundsår o Øjne: sløret syn, synsændringer, øjensmerter o Generelt: feber, hovedpine, træthed, svimmelhed eller besvimelse, mørkfarvet urin, blødning, svaghedsfølelse, følelsesløshed i ben, arme eller ansigt, adfærdsændringer som f.eks. mindre sexlyst, irritabilitet eller glemsomhed
English: • Follow-up of patients due to late onset (months after treatment) of irARs
Danish: • Follow-up af patienter på grund af sene (måneder efter behandlingen) bivirkninger
English: The Member States shall ensure that the Marketing Authorisation Holder provides all physicians who are expected to prescribe YERVOY with the following:
Danish: Medlemslandene skal sikre, at indehaveren af markedsføringstilladelsen forsyner alle de læger, som forventes at ordinere YERVOY med følgende:
English: It also contains prompts to enter contact details of the physician and to alert other physicians that the patient is treated with ipilimumab.
Danish: Det indeholder også en opfordring om at påføre den ordinerende læges kontaktoplysninger og advare andre læger om at patienten er i behandling med ipilimumab.
English: The Card reminds patients about key symptoms that need to be reported immediately to the physician/nurse.
Danish: Kortet minder patienten om de vigtigste symptomer, som straks skal rapporteres til lægen/sygeplejersken.
English: • Information that ipilimumab can cause serious side effects in many parts of the body that can lead to death and need to be addressed immediately
Danish: • Information om at ipilimumab kan forårsage alvorlige bivirkninger i mange dele af kroppen, som kan medføre død og derfor skal behandles straks
English: • Request to inform the physician of all medical conditions before treatment.
Danish: • Anmodning om at fortælle lægen om alle patientens sygdomme før behandlingen.
English: • The importance of not attempting to self-treat any symptoms without consulting their Healthcare professional first.
Danish: • Vigtigheden af at undlade selv at behandle eventuelle symptomer uden først at tale med sundhedspersonalet.