FrancophonIA/ELRC3.0 huggingface dataset:
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS PERFORATED UNIT DOSE BLISTERS
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP PERFORERET ENKELTDOSISBLISTER
English: In 2 pivotal, double-blind, placebo-controlled, clinical trials, a total of 424 patients with euvolemic or hypervolemic hyponatremia (serum sodium < 135 mEq/L) due to a variety of underlying causes (heart failure [HF], liver cirrhosis, SIADH and others) were treated for 30 days with tolvaptan (n = 216) or placebo (n = 208) at an initial dose of 15 mg/day.
Danish: I 2 pivotale, dobbeltblindede, placebokontrollerede, kliniske studier blev i alt 424 patienter med euvolæmisk eller hypervolæmisk hyponatriæmi (serum-natrium < 135 mEq/l) grundet en række underliggende årsager (hjertesvigt, levercirrhose, SIADH m.fl.) behandlet i 30 dage med tolvaptan
English: Caution should be exercised in coadministering CYP3A4 inhibitors (e.g. ketoconazole, macrolide antibiotics, diltiazem) with tolvaptan (see section 4.4).
Danish: Der skal udvises forsigtighed ved samtidig administration af CYP3A4-hæmmere (f.eks. ketoconazol, makrolidantibiotika, diltiazem) og tolvaptan (se pkt.
English: In a post-authorisation safety study of tolvaptan in hyponatremia secondary to SIADH, several cases of hepatic disorders and elevated transaminases were observed (see section 4.8).
Danish: I et sikkerhedsmæssigt studie af tolvaptan efter tilladelse til markedsføring hos patienter med hyponatriæmi sekundært til SIADH sås der adskillige tilfælde af leversygdomme og forhøjede transaminaser (se pkt.
English: Blood urine present1, Alanine aminotransferase increased (see section 4.4)1, Aspartate aminotransferase increased (see section 4.4)1, Blood creatinine
Danish: Undersøgelser blod i urinen1, øget alaninaminotransferase (se pkt.
English: Package leaflet: Information for the user Samsca 7.5 mg tablets Samsca 15 mg tablets Samsca 30 mg tablets tolvaptan
Danish: Indlægsseddel: Information til brugeren Samsca 7,5 mg tabletter Samsca 15 mg tabletter Samsca 30 mg tabletter tolvaptan
English: • if you have difficulties in urination or have an enlarged prostate
Danish: • hvis du har besvær med at lade vandet eller har forstørret blærehalskirtel (prostata)
English: Common (may affect up to 1 in 10 people)
Danish: Almindelige bivirkninger (kan forekomme hos op til 1 ud af 10 brugere)
English: Hydroxypropylcellulose Lactose monohydrate Magnesium stearate Microcrystalline cellulose Indigo carmine aluminium lake (E 132)
Danish: Mikrokrystallinsk cellulose Indigocarmin aluminium lake (E 132)
English: • tiredness, general weakness
Danish: • træthed, almen svaghed
English: Each tablet contains 7.5 mg tolvaptan.
Danish: Hver tablet indeholder 7,5 mg tolvaptan.
English: In post-marketing experience with tolvaptan in ADPKD, acute liver failure requiring liver transplantation has been reported (see section 4.8).
Danish: Efter markedsføringen er der ved brug af tolvaptan til behandling af ADPKD rapporteret om akut leversvigt, hvor levertransplantation var påkrævet (se pkt.
English: Pollakiuria, Polyuria
Danish: Udseende og pakningsstørrelser
English: Samsca 15 mg tablets and Samsca 30 mg tablets 4 years
Danish: Samsca 15 mg tabletter og Samsca 30 mg tabletter 4 år
English: Uncommon (may affect up to 1 in 100 people)
Danish: Ikke almindelige bivirkninger (kan forekomme hos op til 1 ud af 100 brugere)
English: Orthostatic hypotension
Danish: Vaskulære sygdomme ortostatisk hypotension
English: Samsca 7.5 mg tablets Each tablet contains 7.5 mg tolvaptan.
Danish: Samsca 7,5 mg tabletter: Hver tablet indeholder 7,5 mg tolvaptan.
English: Samsca 7.5 mg tablets 5 years
Danish: Samsca 7,5 mg tabletter 5 år
English: How to take Samsca
Danish: Sådan skal du tage Samsca
English: Other medicines and Samsca
Danish: Brug af Samsca sammen med anden medicin
English: Samsca is contraindicated during breast-feeding (see section 4.3).
Danish: Samsca er kontraindiceret under amning (se pkt.
English: For such patients, alternative treatment has to be considered.
Danish: Anden behandling skal overvejes til patienter med et sådant akut behov.
English: Anaphylactic shock,
Danish: Immunsystemet anafylaktisk shock, generaliseret udslæt
English: The primary objective of the study was to compare the effects of tolvaptan + SC with placebo + SC on the time to all-cause mortality and on the time to first occurrence of cardiovascular (CV) mortality or hospitalisation for HF. Tolvaptan treatment had no statistically significant favourable or unfavourable effects on overall survival or the combined endpoint of CV mortality or HF hospitalisation, and did not provide convincing evidence for clinically relevant benefit.
Danish: Behandling med tolvaptan havde ingen statistisk signifikante favorable eller ikke-favorable virkninger på generel overlevelse eller det kombinerede endpoint for kardiovaskulær mortalitet eller indlæggelse for hjertesvigt, og gav ikke overbevisende evidens for klinisk relevant gavn.
English: To achieve the desired level of serum sodium your doctor can give in some instances a lower dose of 7.5 mg.
Danish: I nogle tilfælde kan din læge give dig en lavere dosis på 7,5 mg for at opnå det ønskede niveau af serum-natrium.
English: Samsca 7.5 mg tablets Samsca 15 mg tablets Samsca 30 mg tablets
Danish: Samsca 7,5 mg tabletter Samsca 15 mg tabletter Samsca 30 mg tabletter
English: • find it difficult to urinate
Danish: • har svært ved at lade vandet
English: During titration, patients must be monitored for serum sodium and volume status (see section 4.4).
Danish: Under titrering skal patientens serum-natrium og volumenstatus kontrolleres (se pkt.
English: Samsca 30 mg tablets Each tablet contains 30 mg tolvaptan.
Danish: Samsca 30 mg tabletter: Hver tablet indeholder 30 mg tolvaptan.
English: • find a swelling of the face, lips or tongue, itching, generalised rash, or severe wheezing or breathlessness (symptoms of an allergic reaction).
Danish: • opdager en hævelse i ansigtet, på læberne eller på tungen, hvis du har kløe, generaliseret udslæt,
English: Excipient with known effect 70 mg lactose (as monohydrate) per tablet
Danish: Hjælpestof, som behandleren skal være opmærksom på 70 mg lactose (som monohydrat) pr. tablet
English: Samsca 15 mg tablets Each tablet contains 15 mg tolvaptan.
Danish: Samsca 15 mg tabletter: Hver tablet indeholder 15 mg tolvaptan.
English: • Anuria
Danish: • Anuri
English: Excipient with known effect 51 mg lactose (as monohydrate) per tablet
Danish: Hjælpestof, som behandleren skal være opmærksom på 51 mg lactose (som monohydrat) pr. tablet
English: • if you are allergic to tolvaptan or any of the other ingredients of this medicine (listed in section 6) or if you are allergic to benzazepine or benzazepine derivatives (e.g. benazepril,
Danish: (angivet i punkt 6), eller hvis du er allergisk over for benzazepin eller benzazepinderivater
English: Samsca 7.5 mg tablets EU/1/09/539/005 (10 tablets) EU/1/09/539/006 (30 tablets) EU/1/09/539/007 (10 × 1 tablet) EU/1/09/539/008 (30 × 1 tablet)
Danish: Samsca 7,5 mg tabletter EU/1/09/539/005 (10 tabletter) EU/1/09/539/006 (30 tabletter) EU/1/09/539/007 (10 × 1 tablet) EU/1/09/539/008 (30 × 1 tablet)
English: Samsca 30 mg: Blue, round, shallow-convex tablets with dimensions of Ø8 × 3.0 mm, debossed with “OTSUKA” and “30” on one side.
Danish: Samsca 30 mg: Blå, rund, flad, konveks tablet med størrelsen Ø 8 × 3,0 mm præget med “OTSUKA” og “30” på den ene side.
English: Samsca 7.5 mg tablets tolvaptan
Danish: Samsca 7,5 mg tabletter tolvaptan
English: This leads to a reduction in the amount of water in the body by increasing urine production and as a result it increases the level or concentration of sodium in your blood.
Danish: Herved øges saltindholdet eller -koncentrationen i blodet.
English: Excipient with known effect 35 mg lactose (as monohydrate) per tablet
Danish: Hjælpestof, som behandleren skal være opmærksom på 35 mg lactose (som monohydrat) pr. tablet
English: Samsca contains lactose as an excipient.
Danish: Samsca indeholder lactose som hjælpestof.
English: Constipation, Diarrhoea1, Dry mouth
Danish: Mave-tarm-kanalen kvalme forstoppelse, diarré, tør mund,
English: Syncope1, Headache1, Dizziness1
Danish: Nervesystemet synkope1, hovedpine1, svimmelhed1,
English: Blue, round, shallow-convex tablets with dimensions of Ø8 × 3.0 mm, debossed with “OTSUKA” and “30” on one side.
Danish: Blå, rund, flad, konveks tablet i størrelsen Ø 8 × 3,0 mm præget med “OTSUKA” og “30” på den ene side.
English: Samsca 7.5 mg: Blue, rectangular, shallow-convex tablets with dimensions of 7.7 × 4.35 × 2.5 mm, debossed with “OTSUKA” and “7.5” on one side.
Danish: Samsca 7,5 mg: Blå, rektangulær, flad, konveks tablet med størrelsen 7,7 × 4,35 × 2,5 mm præget med “OTSUKA” og “7.5” på den ene side.
English: Samsca 7.5 mg tablets
Danish: Samsca 7,5 mg tabletter
English: Samsca 15 mg: Blue, triangular, shallow-convex tablets with dimensions of 6.58 × 6.2 × 2.7 mm, debossed with “OTSUKA” and “15” on one side.
Danish: Samsca 15 mg: Blå, trekantet, flad, konveks tablet med størrelsen 6,58 × 6,2 × 2,7 mm præget med “OTSUKA” og “15” på den ene side.
English: Samsca 30 mg tablets
Danish: Samsca 30 mg tabletter
English: Blue, triangular, shallow-convex tablets with dimensions of 6.58 × 6.2 × 2.7 mm, debossed with “OTSUKA” and “15” on one side.
Danish: Blå, trekantet, flad, konveks tablet i størrelsen 6,58 × 6,2 × 2,7 mm præget med “OTSUKA” og “15” på den ene side.
English: Blue, rectangular, shallow-convex tablets with dimensions of 7.7 × 4.35 × 2.5 mm, debossed with “OTSUKA” and “7.5” on one side.
Danish: Blå, rektangulær, flad, konveks tablet i størrelsen 7,7 × 4,35 × 2,5 mm præget med “OTSUKA” og “7.5” på den ene side.
English: Samsca 15 mg and Samsca 30 mg tablets are available as 10 × 1 tablet in PVC/Alu perforated unit dose blisters 30 × 1 tablet in PVC/Alu perforated unit dose blisters
Danish: Samsca 15 mg tabletter og Samsca 30 mg tabletter fås som 10 × 1 tablet i perforeret enkeltdosisblister af PVC/Alu 30 × 1 tablet i perforeret enkeltdosisblister af PVC/Alu
English: • water loss
Danish: • vandtab
English: Samsca 15 mg tablets
Danish: Samsca 15 mg tabletter
English: No clinically significant changes have been seen in clearance for doses ranging from 5 to 60 mg.
Danish: Ingen klinisk signifikante ændringer er blevet set ved clearance ved doser på 5 til 60 mg. Der er meget begrænset information tilgængelig for patienter med alvorligt nedsat leverfunktion (Child-Pugh klasse C).
English: Samsca 7.5 mg tablets are available as 10 tablets in PP/Alu blisters 30 tablets in PP/Alu blisters 10 × 1 tablet in PVC/Alu perforated unit dose blisters 30 × 1 tablet in PVC/Alu perforated unit dose blisters
Danish: Samsca 7,5 mg tabletter fås som 10 tabletter i blister af PP/alu 30 tabletter i blister af PP/alu 10 × 1 tablet i perforeret enkeltdosisblister af PVC/alu 30 × 1 tablet i perforeret enkeltdosisblister af PVC/alu
English: 10 tablets in PP/Alu blisters 30 tablets in PP/Alu blisters 10 × 1 tablet in PVC/Alu perforated unit dose blisters 30 × 1 tablet in PVC/Alu perforated unit dose blisters
Danish: 10 tabletter i blister af PP/alu 30 tabletter i blister af PP/alu 10 × 1 tablet i perforeret enkeltdosisblister af PVC/alu 30 × 1 tablet i perforeret enkeltdosisblister af PVC/alu
English: Samsca 15 mg tablets tolvaptan
Danish: Samsca 15 mg tabletter tolvaptan
English: Samsca 30 mg tablets tolvaptan
Danish: Samsca 30 mg tabletter tolvaptan
English: What Samsca is and what it is used for What you need to know before you take Samsca How to take Samsca
Danish: Det skal du vide, før du begynder at tage Samsca Sådan skal du tage Samsca Bivirkninger
English: Administration of tolvaptan may cause too rapid increases in serum sodium (≥ 12 mmol/L per 24 hours, please see below); therefore, monitoring of serum sodium in all patients must start no later than 4-6 hours after treatment initiation.
Danish: Administration af tolvaptan kan medføre hurtig øgning af serum-natrium (≥ 12 mmol/l pr. døgn, se herunder).
English: Patients who received other treatment for hyponatremia or medicinal products which increase serum sodium concentration (see section 4.5) prior to initiation of treatment with Samsca must be managed very cautiously.
Danish: 4.5), inden start af behandling med Samsca, skal kontrolleres meget nøje.
English: Due to the need for a dose titration phase with close monitoring of serum sodium and volume status (see section 4.4), treatment with Samsca has to be initiated in hospital.
Danish: Behandling med Samsca skal indledes på et hospital på grund af behov for en titreringsfase med nøje kontrol af serum-natrium og volumenstatus (se pkt.
English: EU/1/09/539/005 (10 tablets) EU/1/09/539/006 (30 tablets) EU/1/09/539/007 (10 × 1 tablet) EU/1/09/539/008 (30 × 1 tablet)
Danish: EU/1/09/539/005 (10 tabletter) EU/1/09/539/006 (30 tabletter) EU/1/09/539/007 (10 × 1 tablet) EU/1/09/539/008 (30 × 1 tablet)
English: Concomitant use of Samsca with other treatments for hyponatremia or other medicinal products that increase serum sodium concentration may result in a higher risk for developing rapid correction of serum sodium (see section 4.4) and is therefore not recommended during initial treatment or for other patients with very low baseline serum sodium concentrations where rapid correction may represent a risk for osmotic demyelination (see section 4.4).
Danish: Samtidig anvendelse af Samsca og anden behandling for hyponatriæmi eller andre lægemidler, der øger serum-natrium, kan medføre en højere risiko for at udvikle hurtig korrektion af serum-natrium (se pkt.
English: Hepatic disorders2 Acute hepatic failure3
Danish: Hydroxypropylcellulose Lactosemonohydrat Magnesiumstearat
English: If you take more Samsca than you should
Danish: Hvis du har taget for mange Samsca
English: Bilirubin increased (see section 4.4)1
Danish: 4.4)1, øget aspartataminotransferase (se pkt.
English: Otsuka Pharmaceutical Netherlands B.V. Tel/ Tél: +31 (0) 20 85 46 555
Danish: Tel/ Tél: +31 (0) 20 85 46 555
English: Hepatic impairment
Danish: • akut leversvigt.
English: Asthenia, Pyrexia, Malaise1
Danish: Almene symptomer og reaktioner på administrationsstedet tørst asteni, pyreksi, utilpashed1
English: Otsuka Pharmaceutical Netherlands B.V. Tél/Tel: +31 (0) 20 85 46 555
Danish: Tél/Tel: +31 (0) 20 85 46 555
English: • Periodic Safety Update Reports
Danish: • forhøjede leverenzymer
English: The European Commission granted a marketing authorisation valid throughout the European Union for Onduarp on 24 November 2011.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Onduarp den 24. november 2011.
English: When appropriate, direct switch to Onduarp may be considered.
Danish: Hvis det er hensigtsmæssigt, kan et direkte skift til Onduarp overvejes.
English: The full EPAR for Onduarp can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Onduarp findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: This medicine is the same as Twynsta, which is already authorised in the European Union (EU).
Danish: Dette lægemiddel er identisk med Twynsta, som allerede er godkendt i Den Europæiske Union (EU).
English: This is a summary of the European public assessment report (EPAR) for Onduarp.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Onduarp.
English: The maximum dose is one tablet of the highest strength (80/10 mg) once a day.
Danish: Den maksimale dosis er én tablet med den højeste styrke (80/10 mg) en gang dagligt.
English: The company presented information from scientific literature as well as results from studies with the medicine.
Danish: Virksomheden fremlagde data fra faglitteraturen samt resultaterne fra undersøgelser af lægemidlet.
English: The company that makes Twynsta has agreed that its scientific data can be used for Onduarp (‘informed consent')
Danish: Virksomheden, som fremstiller Twynsta, har givet tilladelse til, at dens videnskabelige oplysninger må anvendes for Onduarp ("informeret samtykke").
English: Onduarp is taken by mouth as one tablet once a day and is used for long-term treatment.
Danish: Onduarp tages gennem munden som én tablet en gang dagligt og anvendes til langtidsbehandling.
English: Other information about Onduarp
Danish: Andre oplysninger om Onduarp:
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Onduarp.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om anvendelsesbetingelserne for Onduarp.
English: What is the risk associated with Onduarp?
Danish: Hvilken risiko er der forbundet med Onduarp?
English: The CHMP noted that patients already taking the two active substances in separate tablets may be more likely to adhere to their treatment if prescribed Onduarp.
Danish: CHMP bemærkede, at patienter, der allerede tager de to aktive stoffer som separate tabletter, har højere sandsynlighed for at følge deres behandling, hvis de ordineres Onduarp.
English: For more information about treatment with Onduarp, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Onduarp, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Onduarp is used to treat essential hypertension (high blood pressure) in adults (aged 18 years or over).
Danish: Onduarp anvendes til behandling af essentiel hypertension (højt blodtryk) hos voksne (18 år og derover).
English: EPAR summary for the public telmisartan / amlodipine
Danish: EPAR - sammendrag for offentligheden telmisartan/amlodipin
English: Onduarp must also not be used in patients who have severe liver or bile problems, shock (a steep fall in blood pressure), severe hypotension (low blood pressure), obstruction to blood flow from the left side of their heart or in patients with heart failure after having a myocardial infarction (heart attack).
Danish: Onduarp må heller ikke anvendes hos patienter, som lider af svære lever- eller galdeproblemer, chok (et brat fald i blodtrykket), svær hypotension (lavt blodtryk) og obstruktion af blodgennemstrømningen fra venstre side af hjertet, eller hos patienter med hjertesvigt efter et myokardieinfarkt (hjerteanfald).
English: The Committee decided that Onduarp's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: Udvalget konkluderede, at fordelene ved Onduarp er større end risiciene, og anbefalede, at der blev udstedt markedsføringstilladelse for Onduarp.
English: The most common side effects with Onduarp (seen in between 1 and 10 patients in 100) are dizziness and peripheral oedema (swelling, especially of the ankles and feet).
Danish: De hyppigste bivirkninger ved Onduarp (som optræder hos mellem 1 og 10 patienter ud af 100) er svimmelhed og perifert ødem (hævelse i navnlig ankler og fødder).
English: Why has Onduarp been approved?
Danish: Hvorfor blev Onduarp godkendt?
English: What is Onduarp?
Danish: Hvad er Onduarp?
English: Studies were also carried to show that Onduarp tablets are absorbed in the same way in the body as separate tablets of amlodipine and telmisartan.
Danish: Der blev ligeledes foretaget undersøgelser for at vise, at Onduarp-tabletter optages på samme måde i kroppen som separate amlodipin- og telmisartan-tabletter.
English: In two other main studies, 1,978 adults whose hypertension had not responded adequately to amlodipine were either given Onduarp or continued to take amlodipine at the same or a higher dose.
Danish: I to andre hovedundersøgelser fik 1 978 voksne, hvis hypertension ikke havde responderet tilstrækkeligt på amlodipin, enten Onduarp eller fortsatte med at tage amlodipin med samme eller højere dosis.
English: Onduarp can also be used in place of treatment with telmisartan and amlodipine in patients who are taking both medicines as separate tablets.
Danish: Onduarp kan ligeledes anvendes i stedet for behandling med telmisartan og amlodipin hos patienter, der tager begge lægemidler som separate tabletter.
English: For a patient who has been taking telmisartan and amlodipine as separate tablets, the dose of Onduarp to be taken depends on the doses of telmisartan and amlodipine that he or she was taking before.
Danish: For en patient, der har taget amlodipin og telmisartan som separate tabletter, afhænger den dosis Onduarp, der skal tages, af de doser telmisartan og amlodipin, som han eller hun har taget tidligere.
English: Onduarp must not be used in people who are hypersensitive (allergic) to telmisartan, amlodipine, other medicines in the ‘dihydropyridine derivatives' class or to any of the other ingredients.
Danish: Onduarp må ikke anvendes hos patienter, der kan være overfølsomme (allergiske) over for telmisartan, amlodipin, andre lægemidler i klassen af "dihydropyridin-derivater" eller andre af indholdsstofferne.
English: Onduarp is used in patients whose blood pressure is not adequately controlled by amlodipine alone.
Danish: Onduarp anvendes til patienter, hvis blodtryk ikke kontrolleres tilstrækkeligt med amlodipin alene.
English: For a patient whose blood pressure is not adequately controlled by amlodipine, separate tablets of amlodipine and telmisartan should be used to adjust the doses before switching to Onduarp.
Danish: Til patienter, hvis blodtryk ikke kontrolleres tilstrækkeligt med amlodipin, bør der anvendes separate tabletter med amlodipin og telmisartan for at justere doserne, før der skiftes til Onduarp.
English: For the full list of all side effects reported with Onduarp, see the package leaflet.
Danish: Den fuldstændige liste over alle de indberettede bivirkninger ved Onduarp fremgår af indlægssedlen.
English: Onduarp is a medicine that contains two active substances, telmisartan and amlodipine.
Danish: Onduarp er et lægemiddel, der indeholder to aktive stoffer, telmisartan og amlodipin.
English: What is Onduarp used for?
Danish: Hvad anvendes Onduarp til?
English: Onduarp contains two active substances, telmisartan and amlodipine.
Danish: Onduarp indeholder to aktive stoffer, telmisartan og amlodipin.
English: What benefit has Onduarp shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Onduarp?
English: How has Onduarp been studied?
Danish: Hvordan blev Onduarp undersøgt?
English: How is Onduarp used?
Danish: Hvordan anvendes Onduarp?
English: In the two other studies, Onduarp was more effective at reducing diastolic blood pressure than continued treatment with amlodipine alone: depending on the strengths of Onduarp and amlodipine, the fall in diastolic blood pressure was greater in patients taking Onduarp by between 1.4 mmHg and 4.9 mmHg.
Danish: Alt efter styrken af Onduarp og amlodipin var faldet i det diastoliske blodtryk større hos patienter, der tog Onduarp, nemlig mellem 1,4 mmHg og 4,9 mmHg.
English: How does Onduarp work?
Danish: Hvordan virker Onduarp?
English: It is important to identify and treat these types of conditions as soon as possible.
Danish: Det er vigtigt at konstatere og behandle disse tilstande så hurtigt som muligt.
English: Distribution, biotransformation and elimination:
Danish: Fordeling, biotransformation og elimination:
English: Your doctor may monitor this after each injection.
Danish: Deres læge bør kontrollere dette efter hver injektion.
English: These finding are therefore considered to be of limited clinical relevance.
Danish: Disse fund anses derfor for at være af begrænset klinisk betydning.
English: Data over a two-year period indicate that Macugen treatment should be initiated as early as possible.
Danish: Data fra en 2-års periode tyder på, at Macugen-behandling bør initieres så tidligt som muligt.
English: It tells you what to do if you have any of these symptoms.
Danish: Her står der, hvad De skal gøre, hvis De eventuelt får nogle af disse symptomer.