FrancophonIA/ELRC3.0 huggingface dataset:
English: For treatment of high blood pressure, the usual dose of Micardis for most patients is one 40 mg tablet once a day to control blood pressure over the 24-hour period.
Danish: Til behandling af forhøjet blodtryk er den normale dosering af Micardis til kontrol af blodtrykket i 24 timer én tablet á 40 mg én gang daglig.
English: In the "Prevention Regimen For Effectively avoiding Second Strokes" (PRoFESS) trial in patients 50 years and older, who recently experienced stroke, an increased incidence of sepsis was noted for telmisartan compared with placebo, 0.70 % vs. 0.49 % [RR 1.43 (95 % confidence interval 1.002.06)]; the incidence of fatal sepsis cases was increased for patients taking telmisartan (0.33 %) vs. patients taking placebo (0.16 %) [RR 2.07 (95 % confidence interval 1.14 - 3.76)].
Danish: I studiet "Prevention Regimen For Effectively avoiding Second Strokes" (PRoFESS) hos patienter på 50 år og ældre, som for nylig har oplevet stroke, blev der observeret en øget incidens af sepsis hos patienter behandlet med telmisartan sammenlignet med placebo, 0,70 % vs. 0,49 % [RR 1,43 (95 %
English: Micardis is available in blister packs containing 14, 28, 56, 84 or 98 tablets, in unit dose blister packs containing 28 x 1, 30 x 1 or 90 x 1 tablets or in multipacks containing 360 (4 packs of 90 x 1) tablets.
Danish: Micardis 40 mg er pakket i blisterpakninger med 14, 28, 56, 84 eller 98 tabletter, i enkeltdosisblisterpakning indeholdende 28 x 1, 30 x 1 eller 90 x 1 tabletter eller i multipakninger indeholdende 360 tabletter (4 pakninger med 90 x 1 tabletter).
English: Micardis 40 mg and 80 mg tablets 4 years
Danish: Micardis 40 mg og 80 mg tabletter 4 år.
English: Micardis is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see pregnancy section).
Danish: Hvis Micardis tages mere end 3 måneder henne i graviditeten, kan det forårsage alvorlige fosterskader (se afsnit Graviditet).
English: Micardis 20 mg tablets EU/1/98/090/009 (14 tablets) EU/1/98/090/010 (28 tablets) EU/1/98/090/011 (56 tablets) EU/1/98/090/012 (98 tablets)
Danish: Micardis 20 mg tabletter EU/1/98/090/009 (14 tabletter) EU/1/98/090/010 (28 tabletter) EU/1/98/090/011 (56 tabletter) EU/1/98/090/012 (98 tabletter)
English: INFORMATION IN BRAILLE Micardis 40 mg
Danish: INFORMATION I BRAILLESKRIFT Micardis 40 mg
English: • Diuretics ('water tablets'), especially if taken in high doses together with Micardis, may lead to excessive loss of body water and low blood pressure (hypotension).
Danish: • Vanddrivende medicin i høje doser kan føre til overdrevent tab af kropsvæske og for lavt blodtryk
English: Micardis 20 mg tablets 3 years
Danish: Micardis 20 mg tabletter 3 år.
English: Micardis is not to be given to patients with cholestasis, biliary obstructive disorders or severe hepatic impairment (see section 4.3) since telmisartan is mostly eliminated with the bile.
Danish: Micardis må ikke gives til patienter med kolestase, obstruktive galdelidelser eller svært nedsat leverfunktion (se pkt.
English: Sepsis* (often called "blood poisoning", is a severe infection with whole-body inflammatory response), rapid swelling of the skin and mucosa (angioedema); these side effects are rare (may affect up to 1 in 1,000 people) but are extremely serious and patients should stop taking the medicine and see their doctor immediately.
Danish: Sepsis* (ofte kaldet "blodforgiftning", en alvorlig infektion med betændelsesreaktion i hele kroppen) eller hurtig hævelse af hud og slimhinder (angioødem).
English: Micardis is also used to reduce cardiovascular events (i.e. heart attack or stroke) in adults who are at risk because they have a reduced or blocked blood supply to the heart or legs, or have had a stroke or have high risk diabetes.
Danish: Micardis bruges også til at nedsætte risikoen for hjerte-kar-hændelser og blodprop i hjernen hos voksne, som har en forøget risiko.
English: INFORMATION IN BRAILLE Micardis 80 mg
Danish: INFORMATION I BRAILLESKRIFT Micardis 80 mg
English: INFORMATION IN BRAILLE Micardis 20 mg
Danish: INFORMATION I BRAILLESKRIFT Micardis 20 mg
English: • If you are taking an ACE-inhibitor or aliskiren (see also information under the headings “Do not take Micardis” and “Warning and precautions”).
Danish: • Hvis du samtidig tager en ACE-hæmmer eller aliskiren (se også information under overskriften
English: Haemoglobin decreased, blood uric acid increased, hepatic enzyme increased, blood creatine phosphokinase increased
Danish: Nedsat hæmoglobin, forhøjet urinsyre, forhøjede leverenzymer,
English: Micardis 40 mg and 80 mg tablets
Danish: Micardis 40 mg og 80 mg tabletter
English: Renal impairment including acute renal failure General disorders and administration site conditions Uncommon: Rare:
Danish: Nedsat nyrefunktion herunder akut nyresvigt Almene symptomer og reaktioner på administrationsstedet
English: White oblong tablets of 4.6 mm engraved with the code number '52H' on one side and the company logo on the other side.
Danish: Hvide aflange 4,6 mm tabletter, hvori firmaets logo og koden 52H er præget.
English: White oblong tablets of 3.8 mm engraved with the code number '51H' on one side and the company logo on the other side.
Danish: Hvide aflange 3,8 mm tabletter, hvori firmaets logo og koden 51H er præget.
English: How to take Micardis
Danish: Sådan skal du tage Micardis
English: You should consult with your doctor if you need to adjust the dose of your other medicine while taking Micardis.
Danish: Du skal derfor tale med din læge om eventuelt at få ændret doseringen af din medicin.
English: Micardis 40 mg tablets EU/1/98/090/001 (14 tablets) EU/1/98/090/002 (28 tablets) EU/1/98/090/003 (56 tablets) EU/1/98/090/004 (98 tablets) EU/1/98/090/013 (28 x 1 tablets) EU/1/98/090/015 (84 tablets) EU/1/98/090/017 (30 x 1 tablets) EU/1/98/090/019 (90 x 1 tablets) EU/1/98/090/021 (4 x (90 x 1) tablets)
Danish: Micardis 40 mg tabletter EU/1/98/090/001 (14 tabletter) EU/1/98/090/002 (28 tabletter) EU/1/98/090/003 (56 tabletter) EU/1/98/090/004 (98 tabletter) EU/1/98/090/013 (28 x 1 tabletter) EU/1/98/090/015 (84 tabletter) EU/1/98/090/017 (30 x 1 tabletter) EU/1/98/090/019 (90 x 1 tabletter) EU/1/98/090/021 (4 x (90 x 1) tabletter)
English: Micardis 40 mg tablets
Danish: Micardis 40 mg tabletter
English: Micardis 80 mg tablets EU/1/98/090/005 (14 tablets) EU/1/98/090/006 (28 tablets) EU/1/98/090/007 (56 tablets) EU/1/98/090/008 (98 tablets) EU/1/98/090/014 (28 x 1 tablets) EU/1/98/090/016 (84 tablets) EU/1/98/090/018 (30 x 1 tablets) EU/1/98/090/020 (90 x 1 tablets) EU/1/98/090/022 (4 x (90 x 1) tablets)
Danish: Micardis 80 mg tabletter EU/1/98/090/005 (14 tabletter) EU/1/98/090/006 (28 tabletter) EU/1/98/090/007 (56 tabletter) EU/1/98/090/008 (98 tabletter) EU/1/98/090/014 (28 x 1 tabletter) EU/1/98/090/016 (84 tabletter) EU/1/98/090/018 (30 x 1 tabletter) EU/1/98/090/020 (90 x 1 tabletter) EU/1/98/090/022 (4 x (90 x 1) tabletter)
English: Micardis belongs to a class of medicines known as angiotensin II receptor antagonists.
Danish: Telmisartan er en angiotensin II-receptorantagonist.
English: Prior treatment with high dose diuretics such as furosemide (loop diuretic) and hydrochlorothiazide (thiazide diuretic) may result in volume depletion, and in a risk of hypotension when initiating therapy with telmisartan.
Danish: Der kan opstå volumendepletion og risiko for hypotension ved initiering af behandling med telmisartan, hvis patienten forudgående har modtaget behandling med høje doser af diuretika såsom furosemid (loop-diuretika) og hydrochlorthiazid (thiazid-diuretika).
English: What Micardis looks like and contents of the pack Micardis 40 mg tablets are white, oblong-shaped, and engraved with the code number '51H' on one side and the company logo on the other side.
Danish: Micardis 40 mg tabletter er hvide aflange tabletter, hvorpå firmaets logo og koden 51H er præget.
English: What Micardis looks like and contents of the pack Micardis 80 mg tablets are white, oblong-shaped and engraved with the code number '52H' on one side and the company logo on the other side.
Danish: Micardis 80 mg tabletter er hvide aflange tabletter, hvorpå firmaets logo og koden 52H er præget.
English: What Micardis is and what it is used for What you need to know before you take Micardis How to take Micardis
Danish: Det skal du vide, før du begynder at tage Micardis Sådan skal du tage Micardis Bivirkninger
English: Micardis 20 mg tablets
Danish: Micardis 20 mg tabletter
English: NAME OF THE MEDICINAL PRODUCT Micardis 40 mg tablets telmisartan
Danish: LÆGEMIDLETS NAVN Micardis 40 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 this side effect), 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.
Danish: Sepsis* (ofte kaldet “blodforgiftning”, en alvorlig infektion med en betændelsesreaktion i hele kroppen, som kan føre til døden), øget antal hvide blodlegemer (eosinofili), for få blodplader (trombocytopeni), alvorlige allergiske reaktioner (anafylaktisk reaktion), overfølsomhedsreaktioner (såsom udslæt, kløe, vejrtrækningsbesvær, hvæsende åndedræt, hævelser i ansigtet og lavt blodtryk), lave blodsukkerniveauer (hos sukkersygepatienter), nervøsitet, søvnighed, nedsat syn, hurtig hjerterytme (puls), mundtørhed, maveuro, smagsforstyrrelser, unormal leverfunktion (japanske patienter har større sandsynlighed for at få denne bivirkning), hurtigt indsættende hævelse af hals og slimhinder (angioødem), som kan være dødelig, eksem, hudrødme, nældefeber, alvorligt medicinudløst udslæt, ledsmerter, smerter i arme og ben, senesmerter, influenzalignende symptomer, nedsat hæmoglobin samt forhøjet urinsyre, forhøjede leverenzymer eller forhøjet kreatinkinase i blodet.
English: Because no information is available regarding the use of Micardis during breast-feeding, Micardis is not recommended and alternative treatments with better established safety profiles during breastfeeding are preferable, especially while nursing a newborn or preterm infant.
Danish: Som alternativ anbefales behandlingsregimer med bedre etablerede sikkerhedsprofiler ved amning, specielt ved amning af nyfødte og præmature spædbørn.
English: What Micardis looks like and contents of the pack Micardis 20 mg tablets are white, round and engraved with the code number '50H' on one side and the company logo on the other side.
Danish: Micardis 20 mg tabletter er hvide runde tabletter, hvorpå firmaets logo og koden 50H er præget.
English: Micardis 80 mg tablets
Danish: Micardis 80 mg tabletter
English: Package leaflet: Information for the user Micardis 40 mg tablets Telmisartan
Danish: Indlægsseddel: Information til brugeren Micardis 40 mg tabletter telmisartan
English: In patients with mild to moderate hepatic impairment, the posology should not exceed 40 mg once daily (see section 4.4).
Danish: Dosis bør ikke overskride 40 mg hos patienter med let til moderat nedsat leverfunktion (se pkt.
English: Package leaflet: Information for the user Micardis 80 mg tablets Telmisartan
Danish: Indlægsseddel: Information til brugeren Micardis 80 mg tabletter telmisartan
English: Package leaflet: Information for the user Micardis 20 mg tablets Telmisartan
Danish: Indlægsseddel: Information til brugeren Micardis 20 mg tabletter telmisartan
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 20 mg telmisartan.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder 20 mg telmisartan
English: NAME OF THE MEDICINAL PRODUCT Micardis 80 mg tablets telmisartan
Danish: LÆGEMIDLETS NAVN Micardis 80 mg tabletter telmisartan
English: NAME OF THE MEDICINAL PRODUCT Micardis 20 mg tablets telmisartan
Danish: LÆGEMIDLETS NAVN Micardis 20 mg tabletter telmisartan
English: • If you are taking an ACE-inhibitor or aliskiren (see also information under the headings “Do not take Micardis” and “Warnings and precautions”).
Danish: ”Tag ikke Micardis” og ”Advarsler og forsigtighedsregler”)
English: Fertility In preclinical studies, no effects of Micardis on male and female fertility were observed.
Danish: I prækliniske studier blev der ikke påvist nedsat fertilitet hos hunner eller hanner ved brug af telmisartan.
English: Sorbitol (E420) Magnesium stearate.
Danish: Povidon (K25), meglumin, natriumhydroxid, sorbitol (E420), magnesiumstearat.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE CARTON OF THE MULTIPACKS OF 360 (4 PACKS OF 90 x 1 TABLETS) - WITHOUT BLUE BOX - 80 mg
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE KARTON TIL DELPAKNING I BUNDTET MULTIPAKNING MED 360 (4 PAKNINGER AF 90 x 1 TABLETTER) - UDEN BLUE BOX - 80 mg
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE CARTON OF THE MULTIPACKS OF 360 (4 PACKS OF 90 x 1 TABLETS) - WITHOUT BLUE BOX - 40 mg
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE KARTON TIL DELPAKNING I BUNDTET MULTIPAKNING MED 360 (4 PAKNINGER AF 90 x 1 TABLETTER) - UDEN BLUE BOX - 40 mg
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER LABEL ON MULTIPACKS OF 360 (4 PACKS OF 90 x 1 TABLETS) BUNDLEDINCLUDING THE BLUE BOX - 80 mg
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE ETIKET PÅ BUNDTET MULTIPAKNING MED 360 TABLETTER (4 PAKNINGER MED 90 x 1 TABLETTER) - MED BLUE BOX - 80 mg
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER LABEL ON MULTIPACKS OF 360 (4 PACKS OF 90 x 1 TABLETS) BUNDLEDINCLUDING THE BLUE BOX - 40 mg
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE ETIKET PÅ BUNDTET MULTIPAKNING MED 360 TABLETTER (4 PAKNINGER MED 90 x 1 TABLETTER) - MED BLUE BOX - 40 mg
English: NAME OF THE MEDICINAL PRODUCT Micardis 20 mg tablets
Danish: LÆGEMIDLETS NAVN Micardis 20 mg tabletter Micardis 40 mg tabletter Micardis 80 mg tabletter
English: Back pain (e.g. sciatica), muscle spasms, myalgia Arthralgia, pain in extremity, tendon pain (tendinitis like symptoms)
Danish: Artralgi, ekstremitetssmerter, senesmerter (tendinitislignende symptomer)
English: The absolute bioavailability is 75%.
Danish: Absolut biotilgængelighed er 75 %.
English: - are 65 years of age or older.
Danish: - Hvis du er 65 år eller ældre.
English: Date of first authorisation: 18 December 2013 Date of latest renewal: 20 November 2018
Danish: Dato for første markedsføringstilladelse: 18. december 2013 Dato for seneste fornyelse: 20. november 2018
English: Take the next dose at the usual time.
Danish: Tag den næste dosis til sædvanlig tid.
English: EXP {MM-YYYY}
Danish: EXP {MM-ÅÅÅÅ}
English: This risk persists until significant remission occurs.
Danish: Denne risiko varer ved, indtil der er sket en signifikant remission af sygdommen.
English: 10 mg/day.
Danish: 10 mg/dag.
English: Impact on human fertility has not been observed so far.
Danish: Påvirkning af human fertilitet er endnu ikke observeret.
English: The mechanism behind this risk is unknown, and it is not known if this risk is also relevant for vortioxetine.
Danish: Mekanismen bag dette er ukendt, og det vides ikke, om denne risiko også er relevant for vortioxetin.
English: Pack of 1 glass bottle.
Danish: Pakning med 1 glasflaske.
English: Take one tablet with a glass of water.
Danish: Tag tabletten med et glas vand.
English: Steady-state plasma concentrations are achieved in approximately 2 weeks.
Danish: Steady state-plasmakoncentrationer nås i løbet af ca. 2 uger.
English: (<1/10,000), not known (cannot be estimated from the available data).
Danish: meget sjælden (<1/10.000) og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: The drops can be mixed with water, juice or other non-alcoholic drinks.
Danish: Dråberne kan blandes med vand, juice eller andre drikke uden alkohol.
English: The list is based on information from clinical trials and post-marketing experience.
Danish: Listen er baseret på information fra kliniske studier og erfaring efter markedsføringen.
English: Tolerability and safety
Danish: Tolerabilitet og sikkerhed
English: Contact your doctor immediately if your newborn baby has any of these symptoms.
Danish: Kontakt straks din læge, hvis din baby får nogen af disse symptomer.
English: Abnormal dreams
Danish: Unormale drømme
English: In the majority of instances, such complications began immediately or soon (<24 hours) after delivery.
Danish: I de fleste tilfælde indtraf disse komplikationer umiddelbart eller kort tid (<24 timer) efter fødslen.
English: Treatment should be continued for at least 6 months after you feel well again.
Danish: Det anbefales, at du fortsætter behandlingen i mindst 6 måneder efter, at du igen har fået det godt.
English: You might ask them to tell you if they think your depression or anxiety is getting worse, or if they are worried about changes in your behaviour.
Danish: Du kan eventuelt bede dem om at fortælle dig, hvis de synes, at din depression eller angst bliver værre, eller hvis de bliver bekymrede over ændringer i din opførsel.
English: Most cases were a combination of airway and skin symptoms.
Danish: De fleste tilfælde var en kombination af luftvejs- og hudsymptomer.
English: * Based on post-marketing cases
Danish: * På grundlag af udvalgte tilfælde efter markedsføring
English: Very common Nausea Common
Danish: Meget almindelig Kvalme Almindelig
English: The mean volume of distribution (Vss) is 2,600 L, indicating extensive extravascular distribution.
Danish: Det gennemsnitlige fordelingsvolumen (Vss) er 2.600 l, hvilket indikerer betydelig ekstravaskulær fordeling.
English: These symptoms usually begin during the first 24 hours after the baby is born.
Danish: Disse symptomer starter normalt inden for 24 timer efter fødslen.
English: No pharmacodynamic interactions were observed.
Danish: Der sås ingen farmakodyanamiske interaktioner.
English: The mean elimination half-life and oral clearance are 66 hours and 33 L/h, respectively.
Danish: Gennemsnitlig halveringstid og oral clearance er henholdsvis 66 timer og 33 l/time.
English: In 1 case, anaphylactic shock was reported.
Danish: I 1 tilfælde blev der rapporteret om anafylaktisk chok.
English: It belongs to a group of medicines called antidepressants.
Danish: Det hører til gruppen af lægemidler, der kaldes antidepressive midler.
English: - if you are allergic to vortioxetine or any of the other ingredients of this medicine (listed in section 6).
Danish: - hvis du er allergisk over for vortioxetin eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i punkt 6).
English: Take Brintellix for as long as your doctor recommends.
Danish: Tag Brintellix, så længe lægen anbefaler det.
English: The requirements for submission of periodic safety reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Danish: Kravene til fremsendelse af periodiske sikkerhedsindberetninger er fastsat på listen over EUreferencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF og alle efterfølgende opdateringer offentliggjort på den europæiske webportal for lægemidler.
English: A risk to the breastfeeding child cannot be excluded.
Danish: En risiko for det ammende barn kan derfor ikke udelukkes.
English: Brintellix oral drops are not to be mixed with other medicinal products.
Danish: Brintellix orale dråber må ikke blandes med andre lægemidler.
English: Component of a multipack, can't be sold separately.
Danish: Indgår i en flerstykspakning og må ikke sælges særskilt.
English: However, alcohol intake is not advisable during antidepressant treatment.
Danish: Indtagelse af alkohol må dog frarådes under antidepressiv behandling.
English: Side effects listed below have been reported in the following frequencies.
Danish: Bivirkningerne nedenfor er indberettet med den angivne hyppighed.
English: Tell your doctor if you are taking any of the following medicines:
Danish: Tal med din læge, hvis du tager et af følgende lægemidler:
English: - are a young adult.
Danish: - Hvis du er ung.
English: These may be increased when first starting antidepressants, since these medicines all take time to work, usually about two weeks but sometimes longer.
Danish: Disse tanker kan forstærkes, når du starter med at tage antidepressiv medicin, fordi medicinen er et stykke tid om at virke, ofte omkring 14 dage, men nogle gange længere tid.
English: It is general clinical experience that the risk of suicide may increase in the early stages of recovery.
Danish: Generel klinisk erfaring viser, at selvmordsrisikoen kan øges i de tidlige stadier af remission.
English: Medical follow-up in a specialised environment is recommended.
Danish: Opfølgning på specialafdeling anbefales.
English: Similar effects were seen in the rabbit at sub-therapeutic exposure.
Danish: Tilsvarende påvirkning sås hos kaniner ved subterapeutisk eksponering.
English: Brintellix has no or negligible influence on the ability to drive and use machines.
Danish: Brintellix påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: The efficacy of vortioxetine increased with increasing dose.
Danish: Effekten af vortioxetin steg med stigende doser.
English: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Danish: Da der ikke foreligger studier over eventuelle forligeligheder, må dette lægemiddel ikke blandes med andre lægemidler.
English: Vortioxetine is slowly, but well absorbed after oral administration and the peak plasma concentration is reached within 7 to 11 hours.
Danish: Vortioxetin absorberes langsomt, men effektivt efter oral administration, og maksimal plasmakoncentration nås i løbet af 7-11 timer.
English: Irreversible non-selective MAOIs
Danish: Irreversible ikke-selektive MAO-hæmmere
English: - have had mania.
Danish: - Hvis du har haft mani.
English: Brintellix is for oral use.
Danish: Brintellix er til oral anvendelse.
English: Depression is associated with an increased risk of suicidal thoughts, self harm and suicide (suicide-related events).
Danish: Depression er forbundet med en øget risiko for selvmordstanker, selvdestruktive handlinger og selvmord (selvmordsrelaterede hændelser).
English: [outer carton only] PC:
Danish: [kun ydre æske] PC:
English: The maintenance of antidepressant efficacy was also demonstrated in this patient population in the long-term relapse prevention study.
Danish: Opretholdelse af den antidepressive effekt blev også påvist hos denne patientpopulation i langtidsstudiet til forebyggelse af recidiv.
English: After the depressive symptoms resolve, treatment for at least 6 months is recommended for consolidation of the antidepressive response.
Danish: Når symptomerne på depression har fortaget sig, anbefales det at fortsætte behandlingen i mindst 6 måneder for at fastholde det antidepressive respons.
English: Gastrointestinal adverse reactions, such as nausea, occurred more frequently in women than men.
Danish: Gastrointestinale bivirkninger såsom kvalme optrådte hyppigere hos kvinder end hos mænd.
English: If you are depressed and/or have anxiety disorders you can sometimes have thoughts of harming or killing yourself.
Danish: Hvis du er deprimeret og/eller lider af angst, kan du sommetider have selvmordstanker eller tanker om at gøre skade på dig selv.