FrancophonIA/ELRC3.0 huggingface dataset:
English: Telmisartan Teva Pharma 20 mg tablets Telmisartan Teva Pharma 40 mg tablets Telmisartan Teva Pharma 80 mg tablets
Danish: Telmisartan Teva Pharma 20 mg tabletter Telmisartan Teva Pharma 40 mg tabletter Telmisartan Teva Pharma 80 mg tabletter
English: Fertility In preclinical studies, no effects of telmisartan on male and female fertility were observed.
Danish: I prækliniske studier blev der ikke påvist nedsat fertilitet hos mænd eller kvinder ved brug af telmisartan.
English: Telmisartan Teva Pharma is contraindicated in patients with severe hepatic impairment (see section 4.3).
Danish: Telmisartan Teva Pharma er kontraindiceret hos patienter med svært nedsat leverfunktion (se pkt.
English: Alternatively, Telmisartan Teva Pharma may be used in combination with diuretics (“water” tablets) such as hydrochlorothiazide which have been shown to have an additive blood pressure lowering effect with Telmisartan Teva Pharma.
Danish: Alternativt kan Telmisartan Teva Pharma også bruges sammen med vanddrivende medicin, såsom hydrochlorthiazid, der har vist sig at øge den blodtryksnedsættende virkning af Telmisartan Teva Pharma.
English: Rare side effects (may affect up to 1 in 1,000 people):
Danish: Sjældne bivirkninger(kan forekomme hos op til 1 ud af 1.000 brugere):
English: Tabulated list of adverse reactions
Danish: Tabuleret liste af bivirkninger
English: The safety and efficacy of Telmisartan Teva Pharma in children and adolescents aged below 18 years have not been established.
Danish: Telmisartan Teva Pharmas sikkerhed og virkning hos børn og unge under 18 år er ikke klarlagt.
English: Telmisartan Teva Pharma may increase the blood pressure lowering effect of other medicines used to treat high blood pressure.
Danish: Telmisartan Teva Pharma kan øge den blodtryksnedsættende virkning af andre blodtryksnedsættende lægemidler.
English: Telmisartan Teva Pharma is also provided in aluminium-aluminium blister packs of 28 tablets.
Danish: Telmisartan Teva Pharma fås også i aluminium-aluminium blistere med 28 tabletter.
English: Telmisartan Teva Pharma is also provided in aluminium-aluminium blister packs of 28 and 30 tablets.
Danish: Telmisartan Teva Pharma fås også i aluminium-aluminium blistere med 28 og 30 tabletter.
English: Should exposure to angiotensin II receptor antagonists have occurred from the second trimester of pregnancy, ultrasound check of renal function and skull is recommended.
Danish: Hvis angiotensin II-receptorantagonister har været anvendt efter start af andet trimester, bør nyrefunktionen og kraniet kontrolleres ved hjælp af ultralyd.
English: Aluminium-Aluminium blisters : pack sizes of 28, 30 tablets
Danish: Aluminium-aluminiumblistere: pakningsstørrelser a 20 og 30 tabletter
English: Telmisartan Teva Pharma contains sodium
Danish: Telmisartan Teva Pharma indeholder natrium
English: • Antidepressants
Danish: • Antidepressiv medicin.
English: Read the package leaflet for further information
Danish: Pakningsstørrelse og yderligere oplysninger
English: Other medicines and Telmisartan Teva Pharma
Danish: Brug af anden medicin sammen med Telmisartan Teva Pharma
English: This medicine contains 21.4 mg sorbitol in each tablet.
Danish: Dette lægemiddel indeholder 21,4 mg sorbitol i hver tablet.
English: Telmisartan Teva Pharma should be used only with caution in patients with mild to moderate hepatic impairment.
Danish: Der bør udvises forsigtighed, når Telmisartan Teva Pharma bruges til patienter med let til moderat nedsat leverfunktion.
English: Uncommon side effects(may affect up to 1 in 100 people):
Danish: Ikke almindelige bivirkninger (kan forekomme hos op til 1 ud af 100 brugere):
English: - if you are taking any of the following medicines used to treat high blood pressure: - an ACE-inhibitor (for example enalapril, lisinopril, ramipril), in particular if you have diabetesrelated kidney problems.
Danish: Kontakt lægen, før du tager Telmisartan Teva Pharma: hvis du tager digoxin - hvis du samtidig tager et af følgende lægemidler til behandling af for højt blodtryk: - en ACE-hæmmer (f.eks. enalapril, lisinopril, ramipril), især hvis du har nyreproblemer i forbindelse med sukkersyge - aliskiren.
English: Актавис ЕАД Тел.
Danish: България Актавис ЕАД
English: This medicine contains 85.6 mg sorbitol in each tablet.
Danish: Dette lægemiddel indeholder 85,6 mg sorbitol i hver tablet.
English: Österreich ratiopharm Arzneimittel Vertriebs-GmbH Tel: +43 1 97 00 7
Danish: Österreich ratiopharm Arzneimittel Vertriebs-GmbH
English: This adverse reaction was reported as common in patients with controlled blood pressure who were treated with telmisartan for the reduction of cardiovascular morbidity on top of standard care.
Danish: Hos patienter med velkontrolleret blodtryk, der var i behandling med telmisartan for reduktion af kardiovaskulær morbiditet i tillæg til standardbehandling, blev hypotension rapporteret som almindeligt forekommende.
English: SN: NN:
Danish: SN:
English: Telmisartan Teva Pharma 20 mg tablets This medicine contains 21.4 mg sorbitol in each tablet.
Danish: Telmisartan Teva Pharma 20 mg tabletter Dette lægemiddel indeholder 21,4 mg sorbitol i hver tablet.
English: • Medicines that may increase blood potassium levels such as salt substitutes containing potassium, potassium-sparing diuretics (certain ‘water tablets'), ACE inhibitors, angiotensin II receptor antagonists, NSAIDs (non steroidal anti-inflammatory medicines, e.g. aspirin or ibuprofen), heparin, immunosuppressives (e.g. cyclosporin or tacrolimus), and the antibiotic trimethoprim.
Danish: • Medicin, som kan forhøje blodets indhold af kalium, såsom kaliumholdige saltsubstitutter, kaliumbesparende medicin (visse typer diuretika eller vanddrivende tabletter), ACEhæmmere, angiotensin II-receptorantagonister, non-steroid antiinflammatorisk medicin (NSAID'er som aspirin og ibuprofen), heparin, lægemidler der undertrykker immunsystemet (som cyclosporin og tacrolimus) og antibiotika indeholdende trimethoprim.
English: This medicine contains 42.8 mg sorbitol in each tablet.
Danish: Dette lægemiddel indeholder 42,8 mg sorbitol i hver tablet.
English: Telmisartan Teva Pharma 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: Telmisartan Teva Pharma må ikke gives til patienter med kolestase, obstruktive galdelidelser eller svært nedsat leverfunktion (se pkt.
English: How to take Telmisartan Teva Pharma
Danish: Sådan skal du tage Telmisartan Teva Pharma
English: Telmisartan Teva Pharma 80 mg tablets This medicine contains 85.6 mg sorbitol in each tablet.
Danish: Telmisartan Teva Pharma 80 mg tabletter Dette lægemiddel indeholder 85,6 mg sorbitol i hver tablet.
English: Respiratory, thoracic and mediastinal disorders Uncommon:
Danish: Hypotension2, ortostatisk hypotension Luftveje, thorax og mediastinum Ikke almindelig:
English: Pregnancy and breast-feeding Pregnancy
Danish: Graviditet og amning
English: Telmisartan Teva Pharma 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: Telmisartan Teva Pharma bruges også til at nedsætte risikoen for hjerte-kar-hændelser og blodprop i hjernen hos voksne, som har en forøget risiko.
English: The adjusted DBP changes from baseline were -8.4 (1.5) mm Hg, -4.5 (1.6) mm Hg and -3.5 (2.1) mm Hg respectively.
Danish: (1,5) mmHg; -4,5 (1,6) mmHg og -3,5 (2,1) mmHg.
English: This applies especially to the medicines listed below taken at the same time with Telmisartan Teva Pharma.
Danish: Muligvis vil det være nødvendigt at stoppe brugen af anden medicin specielt, hvis det er noget af følgende, der tages samtidig med Telmisartan Teva Pharma.
English: Telmisartan Teva Pharma 40 mg tablets This medicine contains 42.8 mg sorbitol in each tablet.
Danish: Telmisartan Teva Pharma 40 mg tabletter Dette lægemiddel indeholder 42,8 mg sorbitol i hver tablet.
English: Each tablet contains 40 mg telmisartan
Danish: Hver tablet indeholder 40 mg telmisartan
English: Pack sizes of 14x1, 28x1, 30x1, 40x1, 56x1, 60x1, 84x1, 90x1, 98x1, 100x1 tablets for peelable perforated blisters.
Danish: Pakningsstørrelser a 14x1, 28x1, 30x1, 40x1, 56x1, 60x1, 84x1, 90x1, 98x1, 100x1 tablet med perforerede blistere.
English: Package leaflet: Information for the user Telmisartan Teva Pharma 40 mg Tablets
Danish: Indlægsseddel: Information til brugeren Telmisartan Teva Pharma 40 mg tabletter
English: What you need to know before you take Telmisartan Teva Pharma Do not take Telmisartan Teva Pharma
Danish: Det skal du vide, før du begynder at tage Telmisartan Teva Pharma Sådan skal du tage Telmisartan Teva Pharma Bivirkninger
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).
Danish: Dobbelt hæmning af renin-angiotensin-aldosteronsystemet (RAAS) Der er tegn på, at samtidig brug af ACE-hæmmere og angiotensin II-receptorantagonister eller aliskiren øger risikoen for hypotension, hyperkaliæmi og nedsat nyrefunktion (inklusive akut nyresvigt).
English: Package leaflet: Information for the user Telmisartan Teva Pharma 20 mg Tablets
Danish: Indlægsseddel: Information til brugeren Telmisartan Teva Pharma 20 mg tabletter
English: Contents of the pack and other information What Telmisartan Teva Pharma contains
Danish: Pakningsstørrelser og yderligere oplysninger Telmisartan Teva Pharma indeholder:
English: Package leaflet: Information for the user Telmisartan Teva Pharma 80 mg Tablets
Danish: Indlægsseddel: Information til brugeren Telmisartan Teva Pharma 80 mg tabletter
English: Each tablet contains 80 mg telmisartan
Danish: Hver tablet indeholder 80 mg telmisartan
English: Each tablet contains 20 mg telmisartan
Danish: Hver tablet indeholder 20 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".
Danish: Telmisartan Teva Pharma 80 mg tabletter er hvide til råhvide, ovale tabletter, hvor den ene side af tabletten er præget med tallet "93".
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".
Danish: Telmisartan Teva Pharma 40 mg tabletter er hvide til råhvide, ovale tabletter, hvor den ene side af tabletten er præget med tallet "93".
English: ONTARGET (ONgoing Telmisartan Alone and in Combination with Ramipril Global Endpoint Trial) compared the effects of telmisartan, ramipril and the combination of telmisartan and ramipril on cardiovascular outcomes in 25620 patients aged 55 years or older with a history of coronary artery disease, stroke, TIA, peripheral arterial disease, or type 2 diabetes mellitus accompanied by evidence of end-organ damage (e.g. retinopathy, left ventricular hypertrophy, macro- or microalbuminuria), which is a population at risk for cardiovascular events.
Danish: De var 55 år eller ældre og havde en anamnese med koronararteriesygdom, apopleksi, transitorisk cerebral iskæmi (TCI), perifer arteriel sygdom eller diabetes mellitus type 2 med en organpåvirkning (f.eks. retinopati, venstre ventrikel hypertrofi, makroeller mikroalbuminuri).
English: Nervous system disorders
Danish: Nervesystemet Ikke almindelig:
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".
Danish: Telmisartan Teva Pharma 20 mg tabletter er hvide til råhvide, ovale tabletter, hvor den ene side af tabletten er præget med tallet "93".
English: Pack sizes of 14x1, 28x1, 30x1, 40x1, 56x1, 60x1, 84x1, 90x1, 98x1, 100x1 tablets for perforated blisters.
Danish: Begge typer blistere fås med 14x1, 28x1, 30x1, 40x1, 56x1, 60x1, 84x1, 90x1, 98x1, 100x1 tablet.
English: Telmisartan was found to be similarly effective to ramipril in the pre-specified secondary endpoint of cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke [0.99 (97.5 % CI 0.90 - 1.08), p (non-inferiority) = 0.0004], the primary endpoint in the reference study HOPE (The Heart Outcomes Prevention Evaluation Study), which had investigated the effect of ramipril vs. placebo.
Danish: Mht. det prædefinerede sekundære endepunkt (reduktion af kardiovaskulær død, ikke-letalt myokardieinfarkt og ikke-letal apopleksi) - som var identisk med det primære endepunkt i HOPEstudiet (The Heart Outcomes Prevention Evaluation Study) blev telmisartan fundet ligeværdig med ramipril [0,99 (97,5% CI 0,90-1,08, p (non-inferioritet) = 0,0004)].
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
Danish: 14x1 tablet 28x1 tablet 30x1 tablet 40x1 tablet 56x1 tablet 60x1 tablet 84x1 tablet 90x1 tablet 98x1 tablet 100x1 tablet 30 tabletter 28 tabletter
English: 14x1 tablets 28x1 tablets 30x1 tablets 40x1 tablets 56x1 tablets 60x1 tablets 84x1 tablets 90x1 tablets 98x1 tablets 100x1 tablets 28 tablets
Danish: 14x1 tablet 28x1 tablet 30x1 tablet 40x1 tablet 56x1 tablet 60x1 tablet 84x1 tablet 90x1 tablet 98x1 tablet 100x1 tablet 28 tabletter
English: Telmisartan Teva Pharma 40 mg tablets
Danish: Telmisartan Teva Pharma 40 mg tabletter
English: Unless continued angiotensin II receptor antagonist therapy is considered essential, patients planning pregnancy should be changed to alternative anti-hypertensive treatments which have an established safety profile for use in pregnancy.
Danish: Patienter, som planlægger graviditet, bør skifte til en alternativ antihypertensiv behandling, der er sikker at anvende for gravide, medmindre fortsat behandling med angiotensin II-receptorantagonist er påkrævet.
English: Telmisartan Teva Pharma 40 mg tablets telmisartan
Danish: Telmisartan Teva Pharma 40 mg tabletter telmisartan
English: Each Telmisartan Teva Pharma tablet contains 40 mg telmisartan.
Danish: En Telmisartan Teva Pharma-tablet indeholder 40 mg telmisartan.
English: Telmisartan Teva Pharma 20 mg tablets telmisartan
Danish: Telmisartan Teva Pharma 20 mg tabletter telmisartan
English: Telmisartan Teva Pharma 20 mg tablets
Danish: Telmisartan Teva Pharma 20 mg tabletter
English: Each Telmisartan Teva Pharma tablet contains 20 mg telmisartan.
Danish: En Telmisartan Teva Pharma-tablet indeholder 20 mg telmisartan.
English: Each Telmisartan Teva Pharma tablet contains 80 mg telmisartan.
Danish: En Telmisartan Teva Pharma-tablet indeholder 80 mg telmisartan.
English: When driving vehicles or operating machinery it should be taken into account that dizziness or drowsiness may occasionally occur when taking antihypertensive therapy such as Telmisartan Teva Pharma.
Danish: Man bør være opmærksom på, at der ved antihypertensiv behandling, som for eksempel med Telmisartan Teva Pharma, lejlighedsvis kan forekomme svimmelhed eller døsighed.
English: Telmisartan Teva Pharma 80 mg tablets
Danish: Telmisartan Teva Pharma 80 mg tabletter
English: Because no information is available regarding the use of Telmisartan Teva Pharma during breast-feeding, Telmisartan Teva Pharma is not recommended and alternative treatments with better established safety profiles during breast-feeding 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: Telmisartan Teva Pharma 80 mg tablets telmisartan
Danish: Telmisartan Teva Pharma 80 mg tabletter telmisartan
English: EU/1/11/719/049 Cartons of 98x1 tablets in peelable perforated unit-dose aluminium-aluminium blisters
Danish: EU/1/11/719/059 Æsker med 98x1 tabletter i perforerede aluminium-aluminium enhedsdosisblistere
English: EU/1/11/719/010 Cartons of 100x1 tablets in peelable perforated unit-dose aluminium aluminium blisters
Danish: EU/1/11/719/060 Æsker med 100x1 tabletter i perforerede aluminium-aluminium enhedsdosisblistere
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.
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 diabetespatienter), nervøsitet, søvnighed, nedsat syn, hurtig hjerterytme (puls), mundtørhed, maveuro, smagsforstyrrelse, unormal leverfunktion (japanske patienter har større sandsynlighed for at få denne bivirkning ), hurtigt indsættende hævelse af hals og slimhinder (som også kan føre til døden) (angioødem, som kan være dødelig), eksem (en hudlidelse), rødmen, nældefeber, alvorligt medicinudløst udslæt, ledsmerter, smerter i arme og ben, senesmerter, influenzalignende symptomer, hæmaglobinmangel, forhøjet urinsyre, kreatinin, leverenzymer og kreatininkinase.
English: Pharma.
Danish: Тел.
English: If you take more Telmisartan Teva Pharma than you should
Danish: Hvis du har taget for mange Telmisartan Teva Pharma-tabletter
English: EU/1/11/719/048 Cartons of 90x1 tablets in peelable perforated unit-dose aluminium-aluminium blisters
Danish: EU/1/11/719/058 Æsker med 90x1 tabletter i perforerede aluminium-aluminium enhedsdosisblistere
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
Danish: EU/1/11/719/041 14x1 tablet EU/1/11/719/042 28x1 tablet EU/1/11/719/043 30x1 tablet EU/1/11/719/044 40x1 tablet EU/1/11/719/045 56x1 tablet EU/1/11/719/046 60x1 tablet EU/1/11/719/047 84x1 tablet EU/1/11/719/048 90x1 tablet EU/1/11/719/049 98x1 tablet EU/1/11/719/050 100x1 tablet
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
Danish: EU/1/11/719/031 14x1 tablet EU/1/11/719/032 28x1 tablet EU/1/11/719/033 30x1 tablet EU/1/11/719/034 40x1 tablet EU/1/11/719/035 56x1 tablet EU/1/11/719/036 60x1 tablet EU/1/11/719/037 84x1 tablet EU/1/11/719/038 90x1 tablet EU/1/11/719/039 98x1 tablet EU/1/11/719/040 100x1 tablet EU/1/11/719/061 30 tabletter EU/1/11/719/064 28 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
Danish: EU/1/11/719/001 14x1 tablet EU/1/11/719/002 28x1 tablet EU/1/11/719/003 30x1 tablet EU/1/11/719/004 40x1 tablet EU/1/11/719/005 56x1 tablet EU/1/11/719/006 60x1 tablet EU/1/11/719/007 84x1 tablet EU/1/11/719/008 90x1 tablet EU/1/11/719/009 98x1 tablet EU/1/11/719/010 100x1 tablet
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
Danish: EU/1/11/719/051 14x1 tablet EU/1/11/719/052 28x1 tablet EU/1/11/719/053 30x1 tablet EU/1/11/719/054 40x1 tablet EU/1/11/719/055 56x1 tablet EU/1/11/719/056 60x1 tablet EU/1/11/719/057 84x1 tablet EU/1/11/719/058 90x1 tablet EU/1/11/719/059 98x1 tablet EU/1/11/719/060 100x1 tablet EU/1/11/719/062 30 tabletter EU/1/11/719/065 28 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
Danish: EU/1/11/719/021 14x1 tablet EU/1/11/719/022 28x1 tablet EU/1/11/719/023 30x1 tablet EU/1/11/719/024 40x1 tablet EU/1/11/719/025 56x1 tablet EU/1/11/719/026 60x1 tablet EU/1/11/719/027 84x1 tablet EU/1/11/719/028 90x1 tablet EU/1/11/719/029 98x1 tablet EU/1/11/719/030 100x1 tablet
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
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 diabetespatienter), 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, som også kan føre til døden) (angioødem, som kan være dødelig), eksem (en hudlidelse), rødmen, nældefeber alvorligt medicinudløst udslæt, ledsmerter, smerter i arme og ben, senesmerter, influenzalignende symptomer, hæmaglobinmangel, forhøjet urinsyre, kreatinin, leverenzymer og kreatininkinase.
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
Danish: EU/1/11/719/011 14x1 tablet EU/1/11/719/012 28x1 tablet EU/1/11/719/013 30x1 tablet EU/1/11/719/014 40x1 tablet EU/1/11/719/015 56x1 tablet EU/1/11/719/016 60x1 tablet EU/1/11/719/017 84x1 tablet EU/1/11/719/018 90x1 tablet EU/1/11/719/019 98x1 tablet EU/1/11/719/020 100x1 tablet EU/1/11/719/063 28 tabletter