FrancophonIA/ELRC3.0 huggingface dataset:
English: There is evidence that the concomitant use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren increases the risk of hypotension, hyperkalaemia and decreased renal function (including acute renal failure).
Norwegian Bokmål: Dobbel blokade av renin-angiotensin-aldosteronsystemet (RAAS) Samtidig bruk av ACE-hemmere, angiotensin-II reseptorantagonister eller aliskiren er vist å gi økt risiko for hypotensjon, hyperkalemi og nedsatt nyrefunksjon (inkludert akutt nyresvikt).
English: Telmisartan Teva Pharma 80 mg tablets Each tablet contains 80 mg telmisartan.
Norwegian Bokmål: Telmisartan Teva Pharma 80 mg tabletter Hver tablett inneholder 80 mg telmisartan.
English: Telmisartan Teva Pharma 40 mg tablets This medicine contains 42.8 mg sorbitol in each tablet.
Norwegian Bokmål: Telmisartan Teva Pharma 40 mg tabletter Dette legemidlet inneholder 42,8 mg sorbitol i hver tablett.
English: Telmisartan Teva Pharma 20 mg tablets Each tablet contains 20 mg telmisartan.
Norwegian Bokmål: Telmisartan Teva Pharma 20 mg tabletter Hver tablett inneholder 20 mg telmisartan.
English: Each tablet contains 40 mg telmisartan
Norwegian Bokmål: Hver tablett inneholder 40 mg telmisartan.
English: Contents of the pack and other information What Telmisartan Teva Pharma contains
Norwegian Bokmål: Innholdet i pakningen og ytterligere informasjon Sammensetning av Telmisartan Teva Pharma
English: Package leaflet: Information for the user Telmisartan Teva Pharma 20 mg Tablets
Norwegian Bokmål: Pakningsvedlegg: Informasjon til brukeren Telmisartan Teva Pharma 20 mg tabletter telmisartan
English: Package leaflet: Information for the user Telmisartan Teva Pharma 40 mg Tablets
Norwegian Bokmål: Pakningsvedlegg: Informasjon til brukeren Telmisartan Teva Pharma 40 mg tabletter telmisartan
English: 14x1 tablets 28x1 tablets 30x1 tablets 40x1 tablets 56x1 tablets 60x1 tablets 84x1 tablets 90x1 tablets 98x1 tablets 100x1 tablets 30 tablets 28 tablets
Norwegian Bokmål: 14x1 tabletter 28x1 tabletter 30x1 tabletter 40x1 tabletter 56x1 tabletter 60x1 tabletter 84x1 tabletter 90x1 tabletter 98x1 tabletter 100x1 tabletter 30 tabletter 28 tabletter
English: Package leaflet: Information for the user Telmisartan Teva Pharma 80 mg Tablets
Norwegian Bokmål: Pakningsvedlegg: Informasjon til brukeren Telmisartan Teva Pharma 80 mg tabletter telmisartan
English: 14x1 tablets 28x1 tablets 30x1 tablets 40x1 tablets 56x1 tablets 60x1 tablets 84x1 tablets 90x1 tablets 98x1 tablets 100x1 tablets 28 tablets
Norwegian Bokmål: 14x1 tabletter 28x1 tabletter 30x1 tabletter 40x1 tabletter 56x1 tabletter 60x1 tabletter 84x1 tabletter 90x1 tabletter 98x1 tabletter 100x1 tabletter 28 tabletter
English: • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1
Norwegian Bokmål: • Overfølsomhet overfor virkestoffet eller overfor noen av hjelpestoffene (se pkt.
English: (angioedema also with fatal outcome), eczema (a skin disorder), redness of skin, hives (urticaria), severe drug rash, joint pain (arthralgia), pain in extremity, tendon pain, flu-like-illness, decreased haemoglobin (a blood protein), increased levels of uric acid, increased hepatic enzymes or creatine phosphokinase in the blood.
Norwegian Bokmål: elveblest (urtikaria), alvorlig legemiddelindusert hudutslett, leddsmerter (artralgi), smerter i armer og ben, senesmerter, influensalignende sykdom, redusert hemoglobin (et blodprotein), forhøyede verdier av urinsyre, forhøyede leverenzymer eller kreatininkinase i blodet.
English: Excipients with known effect Telmisartan Teva Pharma 20 mg tablets Each tablet contains 21.4 mg sorbitol (E420) Telmisartan Teva Pharma 40 mg tablets Each tablet contains 42.8 mg sorbitol (E420) Telmisartan Teva Pharma 80 mg tablets Each tablet contains 85.6 mg sorbitol (E420) For the full list of excipients, see section 6.1.
Norwegian Bokmål: Hjelpestoffer med kjent effekt Telmisartan Teva Pharma 20 mg tabletter Hver tablett inneholder 21,4 mg sorbitol (E420).
English: Telmisartan Teva Pharma 40 mg tablets
Norwegian Bokmål: Telmisartan Teva Pharma 40 mg tabletter
English: Each Telmisartan Teva Pharma tablet contains 40 mg telmisartan.
Norwegian Bokmål: Hver Telmisartan Teva Pharma tablett inneholder 40 mg telmisartan.
English: Telmisartan Teva Pharma 80 mg tablets are white to off white, oval shaped tablets; one side of the tablet is debossed with the number "93".
Norwegian Bokmål: Telmisartan Teva Pharma 80 mg tabletter er hvite til off-white, ovalformede tabletter.
English: Telmisartan Teva Pharma 40 mg tablets are white to off white, oval shaped tablets; one side of the tablet is debossed with the number "93".
Norwegian Bokmål: Telmisartan Teva Pharma 40 mg tabletter er hvite til off-white, ovalformede tabletter.
English: Telmisartan Teva Pharma 40 mg tablets telmisartan
Norwegian Bokmål: Telmisartan Teva Pharma 40 mg tabletter telmisartan
English: Telmisartan Teva Pharma 20 mg tablets
Norwegian Bokmål: Telmisartan Teva Pharma 20 mg tabletter
English: Each Telmisartan Teva Pharma tablet contains 20 mg telmisartan.
Norwegian Bokmål: Hver Telmisartan Teva Pharma tablett inneholder 20 mg telmisartan.
English: Each tablet contains 80 mg telmisartan
Norwegian Bokmål: Hver tablett inneholder 80 mg telmisartan.
English: Telmisartan Teva Pharma 80 mg tablets
Norwegian Bokmål: Telmisartan Teva Pharma 80 mg tabletter
English: Telmisartan Teva Pharma 20 mg tablets are white to off white, oval shaped tablets; one side of the tablet is debossed with the number "93".
Norwegian Bokmål: Telmisartan Teva Pharma 20 mg tabletter er hvite til off-white, ovalformede tabletter.
English: Telmisartan Teva Pharma 20 mg tablets telmisartan
Norwegian Bokmål: Telmisartan Teva Pharma 20 mg tabletter telmisartan
English: Each tablet contains 20 mg telmisartan
Norwegian Bokmål: Hver tablett inneholder 20 mg telmisartan.
English: Each Telmisartan Teva Pharma tablet contains 80 mg telmisartan.
Norwegian Bokmål: Hver Telmisartan Teva Pharma tablett inneholder 80 mg telmisartan.
English: EU/1/11/719/035 Cartons of 56x1 tablets in perforated unit-dose aluminium-aluminium blisters EU/1/11/719/036 Cartons of 60x1 tablets in perforated unit-dose aluminium-aluminium blisters EU/1/11/719/037 Cartons of 84x1 tablets in perforated unit-dose aluminium-aluminium blisters EU/1/11/719/038 Cartons of 90x1 tablets in perforated unit-dose aluminium-aluminium blisters EU/1/11/719/039 Cartons of 98x1 tablets in perforated unit-dose aluminium-aluminium blisters EU/1/11/719/040 Cartons of 100x1 tablets in perforated unit-dose aluminium-aluminium blisters EU/1/11/719/061 Carton of 30 tablets in aluminium-aluminium blister EU/1/11/719/064 Carton of 28 tablets in aluminium-aluminium blister
Norwegian Bokmål: EU/1/11/719/056 Esker med 60x1 tabletter i perforerte aluminium-aluminium endoseblisterpakninger EU/1/11/719/057 Esker med 84x1 tabletter i perforerte aluminium-aluminium endoseblisterpakninger EU/1/11/719/058 Esker med 90x1 tabletter i perforerte aluminium-aluminium endoseblisterpakninger EU/1/11/719/059 Esker med 98x1 tabletter i perforerte aluminium-aluminium endoseblisterpakninger EU/1/11/719/060 Esker med 100x1 tabletter i perforerte aluminium-aluminium endoseblisterpakninger EU/1/11/719/062 Esker med 30 tabletter i aluminium-aluminium blisterpakninger EU/1/11/719/065 Esker med 28 tabletter i aluminium-aluminium blisterpakninger
English: Telmisartan Teva Pharma 80 mg tablets telmisartan
Norwegian Bokmål: Telmisartan Teva Pharma 80 mg tabletter telmisartan
English: Sepsis* (often called "blood poisoning", is a severe infection with whole-body inflammatory response which can lead to death), increase in certain white blood cells (eosinophilia), low platelet count (thrombocytopenia), severe allergic reaction (anaphylactic reaction), allergic reaction (e.g. rash, itching, difficulty breathing, wheezing, swelling of the face or low blood pressure), low blood sugar levels (in diabetic patients), feeling anxious, somnolence, impaired vision, fast heart beat (tachycardia), dry mouth, upset stomach, taste disturbance (dysgeusia), abnormal liver function (Japanese patients are more likely to experience these side effects), rapid swelling of the skin and mucosa which can also lead to death (angioedema also with fatal outcome), eczema (a skin disorder), redness of skin, hives (urticaria), severe drug rash, joint pain (arthralgia), pain in extremity, tendon pain, flu-like-illness, decreased haemoglobin (a blood protein), increased levels of uric acid, increased hepatic enzymes or creatine phosphokinase in the blood.
Norwegian Bokmål: utslett, kløe, pusteproblemer, piping når man puster, hevelse i ansiktet eller lavt blodtrykk), lavt blodsukkernivå (hos diabetikere), angst, søvnighet, synsforstyrrelse, hurtig hjerterytme (takykardi), munntørrhet, urolig mage, smaksforstyrrelser (dysgeusi), unormal leverfunksjon (japanske pasienter har større sannsynlighet for å oppleve denne bivirkningen), raskt innsettende hevelse i hud og slimhinner som også kan føre til døden (angioødem, også med dødelig utfall), eksem (en hudsykdom), rødme i huden, elveblest (urtikaria), alvorlig legemiddelindusert hudutslett, leddsmerter (artralgi), smerter i armer og ben, senesmerter, influensalignende sykdom, redusert hemoglobin (et blodprotein), forhøyede verdier av urinsyre, forhøyede leverenzymer eller kreatininkinase i blodet.
English: Talk to your doctor before taking Telmisartan Teva Pharma: - if you are taking digoxin.
Norwegian Bokmål: Informer legen om at du tar Telmisartan Teva Pharma dersom du skal gjennomgå et kirurgisk inngrep eller trenger bedøvelse (anestesi).
English: Pharma.
Norwegian Bokmål: Cmax.
English: If any of the above applies to you, tell your doctor or pharmacist before taking Telmisartan Teva
Norwegian Bokmål: Informer lege eller apotek før du begynner å bruke Telmisartan Teva Pharma hvis noe av dette gjelder deg.
English: Blood and the lymphatic system disorders Uncommon:
Norwegian Bokmål: Sepsis inkludert fatal utgang1 Sykdommer i blod og lymfatiske organer Mindre vanlige:
English: If you take more Telmisartan Teva Pharma than you should
Norwegian Bokmål: Dersom du tar for mye av Telmisartan Teva Pharma
English: EU/1/11/719/041 14x1 tablets EU/1/11/719/042 28x1 tablets EU/1/11/719/043 30x1 tablets EU/1/11/719/044 40x1 tablets EU/1/11/719/045 56x1 tablets EU/1/11/719/046 60x1 tablets EU/1/11/719/047 84x1 tablets EU/1/11/719/048 90x1 tablets EU/1/11/719/049 98x1 tablets EU/1/11/719/050 100x1 tablets
Norwegian Bokmål: EU/1/11/719/041 14x1 tabletter EU/1/11/719/042 28x1 tabletter EU/1/11/719/043 30x1 tabletter EU/1/11/719/044 40x1 tabletter EU/1/11/719/045 56x1 tabletter EU/1/11/719/046 60x1 tabletter EU/1/11/719/047 84x1 tabletter EU/1/11/719/048 90x1 tabletter EU/1/11/719/049 98x1 tabletter EU/1/11/719/050 100x1 tabletter
English: EU/1/11/719/001 14x1 tablets EU/1/11/719/002 28x1 tablets EU/1/11/719/003 30x1 tablets EU/1/11/719/004 40x1 tablets EU/1/11/719/005 56x1 tablets EU/1/11/719/006 60x1 tablets EU/1/11/719/007 84x1 tablets EU/1/11/719/008 90x1 tablets EU/1/11/719/009 98x1 tablets EU/1/11/719/010 100x1 tablets
Norwegian Bokmål: EU/1/11/719/001 14x1 tabletter EU/1/11/719/002 28x1 tabletter EU/1/11/719/003 30x1 tabletter EU/1/11/719/004 40x1 tabletter EU/1/11/719/005 56x1 tabletter EU/1/11/719/006 60x1 tabletter EU/1/11/719/007 84x1 tabletter EU/1/11/719/008 90x1 tabletter EU/1/11/719/009 98x1 tabletter EU/1/11/719/010 100x1 tabletter
English: EU/1/11/719/021 14x1 tablets EU/1/11/719/022 28x1 tablets EU/1/11/719/023 30x1 tablets EU/1/11/719/024 40x1 tablets EU/1/11/719/025 56x1 tablets EU/1/11/719/026 60x1 tablets EU/1/11/719/027 84x1 tablets EU/1/11/719/028 90x1 tablets EU/1/11/719/029 98x1 tablets EU/1/11/719/030 100x1 tablets
Norwegian Bokmål: EU/1/11/719/021 14x1 tabletter EU/1/11/719/022 28x1 tabletter EU/1/11/719/023 30x1 tabletter EU/1/11/719/024 40x1 tabletter EU/1/11/719/025 56x1 tabletter EU/1/11/719/026 60x1 tabletter EU/1/11/719/027 84x1 tabletter EU/1/11/719/028 90x1 tabletter EU/1/11/719/029 98x1 tabletter EU/1/11/719/030 100x1 tabletter
English: EU/1/11/719/031 14x1 tablets EU/1/11/719/032 28x1 tablets EU/1/11/719/033 30x1 tablets EU/1/11/719/034 40x1 tablets EU/1/11/719/035 56x1 tablets EU/1/11/719/036 60x1 tablets EU/1/11/719/037 84x1 tablets EU/1/11/719/038 90x1 tablets EU/1/11/719/039 98x1 tablets EU/1/11/719/040 100x1 tablets EU/1/11/719/061 30 tablets EU/1/11/719/064 28 tablets
Norwegian Bokmål: EU/1/11/719/031 14x1 tabletter EU/1/11/719/032 28x1 tabletter EU/1/11/719/033 30x1 tabletter EU/1/11/719/034 40x1 tabletter EU/1/11/719/035 56x1 tabletter EU/1/11/719/036 60x1 tabletter EU/1/11/719/037 84x1 tabletter EU/1/11/719/038 90x1 tabletter EU/1/11/719/039 98x1 tabletter EU/1/11/719/040 100x1 tabletter EU/1/11/719/061 30 tabletter EU/1/11/719/064 28 tabletter
English: Sepsis* (often called "blood poisoning", is a severe infection with whole-body inflammatory response which can lead to death), increase in certain white blood cells (eosinophilia), low platelet count (thrombocytopenia), severe allergic reaction (anaphylactic reaction), allergic reaction (e.g. rash, itching, difficulty breathing, wheezing, swelling of the face or low blood pressure), low blood sugar levels (in diabetic patients), feeling anxious, somnolence, impaired vision, fast heart beat (tachycardia), dry mouth, upset stomach, taste disturbance (dysgeusia), abnormal liver function (Japanese patients are more likely to experience these side effects), rapid swelling of the skin and mucosa which can also lead to death
Norwegian Bokmål: utslett, kløe, pusteproblemer, piping når man puster, hevelse i ansiktet eller lavt blodtrykk), lavt blodsukkernivå (hos diabetikere), angst, søvnighet, synsforstyrrelse, hurtig hjerterytme (takykardi), munntørrhet, urolig mage, smaksforstyrrelser (dysgeusi), unormal leverfunksjon (japanske pasienter har større sannsynlighet for å oppleve denne bivirkningen), raskt innsettende hevelse i hud og slimhinner som også kan føre til døden (angioødem, også med dødelig utfall), eksem (en hudsykdom), rødme i huden,
English: EU/1/11/719/051 14x1 tablets EU/1/11/719/052 28x1 tablets EU/1/11/719/053 30x1 tablets EU/1/11/719/054 40x1 tablets EU/1/11/719/055 56x1 tablets EU/1/11/719/056 60x1 tablets EU/1/11/719/057 84x1 tablets EU/1/11/719/058 90x1 tablets EU/1/11/719/059 98x1 tablets EU/1/11/719/060 100x1 tablets EU/1/11/719/062 30 tablets EU/1/11/719/065 28 tablets
Norwegian Bokmål: EU/1/11/719/051 14x1 tabletter EU/1/11/719/052 28x1 tabletter EU/1/11/719/053 30x1 tabletter EU/1/11/719/054 40x1 tabletter EU/1/11/719/055 56x1 tabletter EU/1/11/719/056 60x1 tabletter EU/1/11/719/057 84x1 tabletter EU/1/11/719/058 90x1 tabletter EU/1/11/719/059 98x1 tabletter EU/1/11/719/060 100x1 tabletter EU/1/11/719/062 30 tabletter EU/1/11/719/065 28 tabletter
English: EU/1/11/719/011 14x1 tablets EU/1/11/719/012 28x1 tablets EU/1/11/719/013 30x1 tablets EU/1/11/719/014 40x1 tablets EU/1/11/719/015 56x1 tablets EU/1/11/719/016 60x1 tablets EU/1/11/719/017 84x1 tablets EU/1/11/719/018 90x1 tablets EU/1/11/719/019 98x1 tablets EU/1/11/719/020 100x1 tablets EU/1/11/719/063 28 tablets
Norwegian Bokmål: EU/1/11/719/011 14x1 tabletter EU/1/11/719/012 28x1 tabletter EU/1/11/719/013 30x1 tabletter EU/1/11/719/014 40x1 tabletter EU/1/11/719/015 56x1 tabletter EU/1/11/719/016 60x1 tabletter EU/1/11/719/017 84x1 tabletter EU/1/11/719/018 90x1 tabletter EU/1/11/719/019 98x1 tabletter EU/1/11/719/020 100x1 tabletter EU/1/11/719/063 28 tabletter
English: Metabolism and nutrition disorders Uncommon:
Norwegian Bokmål: Anafylaktisk reaksjon, hypersensitivitet, Stoffskifte- og ernæringsbetingede sykdommer Mindre vanlige:
English: TEVA Pharmaceutical Works Private Limited Company H-4042 Debrecen,
Norwegian Bokmål: TEVA Pharmaceutical Works Private Limited Company Táncsics Mihály út 82
English: MA (EU) number (Invented) name Strength Pharmaceutical Form Route of Administration Immediate Packaging Pack size EU/1/15/1037/001 Pemetrexed Sandoz 100 mg Powder for concentrate for solution for infusion
Norwegian Bokmål: Legemidlets navn Styrke Legemiddelform
English: Packaging Content Package size
Norwegian Bokmål: Emballasje Innhold
English: Spedra should not be taken by children and adolescents under 18 years of age.
Norwegian Bokmål: Spedra skal ikke tas av barn og ungdom under 18 år.
English: You may get more side effects than usual and they may be worse.
Norwegian Bokmål: Du kan få flere bivirkninger enn vanlig og de kan være verre.
English: ATC code: G04BE10.
Norwegian Bokmål: ATC-kode: G04BE10.
English: (including not being able to get erections).
Norwegian Bokmål: (inkludert manglende evne til å få ereksjoner)
English: You should not take Spedra more than once a day.
Norwegian Bokmål: Du skal ikke ta Spedra mer enn én gang daglig.
English: Do not take Spedra:
Norwegian Bokmål: Bruk ikke Spedra:
English: • an erection that will not go away (“priapism”).
Norwegian Bokmål: • en ereksjon som ikke vil forsvinne ("priapisme").
English: It may be risky for you to have sexual intercourse
Norwegian Bokmål: Det kan være risikabelt for deg å ha samleie
English: The maximum recommended dosing frequency is once per day.
Norwegian Bokmål: Maksimal anbefalt doseringsfrekvens er én gang daglig.
English: Consideration should be given to the following:
Norwegian Bokmål: Følgende bør vurderes:
English: There was no effect on the extent of exposure (AUC).
Norwegian Bokmål: Det var ingen effekt på eksponeringsgraden (AUC).
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA PC: {number}
Norwegian Bokmål: UNIQUE IDENTIFIER - HUMAN READABLE DATA PC: {nummer}
English: • pink or red urine, blood in the urine
Norwegian Bokmål: • rosa eller rød urin, blod i urinen
English: Spedra is not for women.
Norwegian Bokmål: Spedra er ikke for kvinner.
English: If you get an erection that lasts more than
Norwegian Bokmål: Dersom du får en ereksjon som varer mer enn
English: Spedra does not cure your condition.
Norwegian Bokmål: Spedra kurerer ikke tilstanden din.
English: • If you have had a stroke or heart attack in the last 6 months
Norwegian Bokmål: • dersom du har hatt slag eller hjerteinfarkt de siste 6 månedene
English: Patients should be informed not to take Spedra in such combinations.
Norwegian Bokmål: Pasienter bør informeres om at de ikke skal ta Spedra i slike kombinasjoner.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 21 June 2013
Norwegian Bokmål: DATO FOR FØRSTE MARKEDSFØRINGSTILLATELSE / SISTE FORNYELSE Dato for første markedsføringstillatelse: 21. juni 2013
English: Sexual stimulation is required for a response to treatment.
Norwegian Bokmål: Seksuell stimulering er nødvendig for behandlingsrespons.
English: 4 hours, this must be treated as soon as possible or lasting damage can happen to your penis
Norwegian Bokmål: 4 timer, må dette behandles så raskt som mulig, ellers kan det oppstå varige skader i penis
English: Avanafil has a terminal half-life of approximately 6-17 hours.
Norwegian Bokmål: Avanafil har en terminal halveringstid på ca. 6-17 timer.
English: You and your partner will still need to use foreplay to get ready for sex - just as you would if you were not taking a medicine to help you.
Norwegian Bokmål: Du og partneren din må fortsatt ha forspill for å bli klare for sex - på samme måte som dere ville ha hatt dersom du ikke tok et legemiddel for å hjelpe deg.
English: However, data on subjects older than 70 years are limited.
Norwegian Bokmål: Data for forsøkspersoner over 70 år er imidlertid begrensede.
English: • If you suffer from priapism, that is a persistent erection lasting 4 hours or more.
Norwegian Bokmål: • dersom du lider av priapisme, som er en langvarig ereksjon som varer i 4 timer eller mer.
English: Spedra with drink and alcohol
Norwegian Bokmål: Inntak av Spedra sammen med drikke og alkohol
English: Avanafil has no effect in the absence of sexual stimulation.
Norwegian Bokmål: Avanafil har ingen effekt i fravær av seksuell stimulering.
English: Avanafil is rapidly absorbed.
Norwegian Bokmål: Avanafil absorberes raskt.
English: Avanafil is approximately 99% bound to plasma proteins.
Norwegian Bokmål: Avanafil er ca. 99 % bundet til plasmaproteiner.
English: It is not known if these problems are related directly to Spedra, other diseases that you may have or a combination of factors.
Norwegian Bokmål: Det er ikke kjent om disse problemene er direkte relatert til Spedra, andre sykdommer du kan ha eller en kombinasjon av faktorer.
English: • spontaneous erection without sexual stimulation
Norwegian Bokmål: • spontan ereksjon uten seksuell stimulering
English: SN: {number}
Norwegian Bokmål: SN: { nummer }
English: If you are taking riociguat or are unsure tell your doctor.
Norwegian Bokmål: Hvis du tar riociguat eller er usikker, ta det opp med legen din.
English: These exposure changes are not considered clinically significant.
Norwegian Bokmål: Disse eksponeringsendringene anses ikke klinisk signifikante.
English: • If you are allergic to avanafil or any of the other ingredients of this medicine (listed in section 6)
Norwegian Bokmål: • dersom du er allergisk overfor avanafil eller noen av de andre innholdsstoffene i dette legemidlet (listet opp i avsnitt 6)
English: • If you have low blood pressure or high blood pressure not controlled by medicines
Norwegian Bokmål: • dersom du har lavt blodtrykk eller høyt blodtrykk som ikke er kontrollert med legemidler
English: NN: {number}
Norwegian Bokmål: NN: { nummer }
English: • sudden decrease or loss of vision in one or both eyes.
Norwegian Bokmål: • plutselig synsreduksjon eller synstap på ett eller begge øyne
English: What Spedra is and what it is used for
Norwegian Bokmål: Hva Spedra er og hva det brukes mot
English: Patients who experience erections lasting 4 hours or more (priapism) should be instructed to seek immediate medical assistance.
Norwegian Bokmål: Pasienter som får ereksjoner som varer 4 timer eller mer (priapisme) bør anmodes om å oppsøke legehjelp omgående.
English: Therefore, avanafil should be administered to such patients only after careful benefit-risk assessment.
Norwegian Bokmål: Avanafil skal derfor kun gis til slike pasienter etter grundig nytte-risikovurdering.
English: • sudden decrease or loss of hearing (sometimes you may also feel dizzy or have ringing in your ears).
Norwegian Bokmål: • plutselig hørselsreduksjon eller hørselsstap (noen ganger kan du også føle deg svimmel eller få øresus).
English: Spedra has minor influence on the ability to drive and use machines.
Norwegian Bokmål: Spedra har liten påvirkning på evnen til å kjøre bil og bruke maskiner.
English: Limited data are available in elder patients aged 70 years or above.
Norwegian Bokmål: Det foreligger begrensede data for eldre pasienter som er 70 år eller eldre.
English: Sanofi Winthrop Industrie 1, rue de la Vierge Ambares et Lagrave 33565 Carbon-Blanc-Cedex France
Norwegian Bokmål: Sanofi Winthrop Industrie 1, rue de la Vierge Ambares et Lagrave 33565 Carbon-Blanc-Cedex Frankrike
English: • If you are taking riociguat.
Norwegian Bokmål: • Dersom du tar riociguat.
English: The safety profile of Spedra is based on 2,566 subjects exposed to avanafil during the clinical development program.
Norwegian Bokmål: Sikkerhetsprofilen til Spedra er basert på 2566 forsøkspersoner eksponert for avanafil i det kliniske utviklingsprogrammet.
English: Concomitant use of alcohol
Norwegian Bokmål: Samtidig bruk av alkohol
English: Adverse reaction (MedDRA Preferred Term) System Organ Class Common
Norwegian Bokmål: Bivirkning (foretrukket MedDRA-betegnelse) Organklassesystem Vanlige
English: This is when you cannot get, or keep a hard, erect penis suitable for sexual activity.
Norwegian Bokmål: Dette innebærer at du ikke kan få eller beholde en hard, erigert penis egnet for seksuell aktivitet.
English: The M16 metabolite was inactive against PDE5.
Norwegian Bokmål: M16metabolitten var inaktiv overfor PDE5.
English: Older patients (65 years or over) had comparable exposure to that seen in younger patients (18-45 years).
Norwegian Bokmål: Eldre pasienter (65 år eller eldre) hadde sammenlignbar eksponering med det som ses hos yngre pasienter (18-45 år).