FrancophonIA/ELRC3.0 huggingface dataset:
English: The other ingredients are microcrystalline cellulose (E460), lactose monohydrate, pregelatinized maize starch, magnesium stearate (E572), hydroxypropyl cellulose (E463), hypromellose (E464).
Danish: magnesiumstearat (E572), hydroxypropylcellulose (E463), hypromellose (E464).
English: White, oval film-coated tablets marked 952 on one side and scored on the other.
Danish: Hvide, ovale filmovertrukne tabletter mærket 952 på den ene side og med delekærv på den anden side.
English: Blister for Cozaar 12.5 mg film-coated tablets Blister for Cozaar 50 mg film-coated tablets
Danish: Blister til Cozaar 12,5 mg filmovertrukne tabletter Blister til Cozaar 50 mg filmovertrukne tabletter
English: Lactose monohydrate.
Danish: Lactosemonohydrat.
English: Losartan is an orally active angiotensin II (Ang- II) receptor antagonist acting on the AT1 receptor subtype, thus blocking the effect of Ang-II in the renin angiotensin system (RAS) cascade.
Danish: Losartan er en oralt aktiv angiotensin II (Ang-II)-receptorantagonist, der påvirker AT1-receptorundertypen.
English: If your heart failure has been stabilised with an ACE inhibitor you should not be switched to losartan .
Danish: Hvis Deres nedsatte hjertefunktion er blevet stabiliseret med ACE-hæmmere, behøver De ikke at skifte til Cozaar;
English: DATE OF REVISION OF THE TEXT {MM/YYYY}
Danish: DATO FOR ÆNDRING AF TEKSTEN
English: Patients with Heart Failure Treatment usually starts with 12.5 mg losartan (one tablet Cozaar 12.5 mg) once a day.
Danish: Behandlingen starter normalt med 12,5 mg losartan (en tablet Cozaar 12,5 mg) én gang dagligt.
English: Each tablet contains the following inactive ingredients: microcrystalline cellulose (E460) lactose monohydrate pregelatinized maize starch magnesium stearate (E572) hydroxypropyl cellulose (E463) hypromellose (E464)
Danish: Hver tablet indeholder følgende inaktive indholdsstoffer: Mikrokrystallinsk cellulose (E460) Lactosemonohydrat
English: PHARMACEUTICAL FORM AND CONTENTS 100 film-coated tablets.
Danish: LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE) 100 filmovertrukne tabletter.
English: PHARMACEUTICAL FORM AND CONTENTS 100 tablets.
Danish: LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE) 100 tabletter.
English: • dose-related orthostatic effects such as lowering of blood pressure appearing when rising from a lying or sitting position,
Danish: • Blodtryksfald, der viser sig, når man rejser sig fra liggende eller siddende stilling, og som kan have forbindelse til størrelsen af dosis
English: Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Herts EN11 9BU
Danish: Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Herts EN11 9BU, Storbritannien
English: The following adverse events occurred more often in patients receiving losartan than placebo: Blood and lymphatic system disorders: not known: anaemia
Danish: Følgende bivirkninger forekom oftere hos patienter, der fik losartan end placebo:
English: Merck Sharp & Dohme GmbH Donau-City-Straße 6
Danish: Merck Sharp & Dohme GmbH Donau-City-Straße 6, 1220 Wien, Østrig
English: The following wording has been added to the Package Leaflet Section 2 Before you take Cozaar: Use in children and adolescents <COZAAR> has been studied in children.
Danish: Følgende ordlyd er tilføjet indlægssedlen, afsnit 2 Vigtig information som De skal læse, før De tager COZAAR:
English: HOW TO TAKE Cozaar
Danish: SÅDAN SKAL DE TAGE COZAAR
English: PHARMACEUTICAL FORM AND CONTENTS 7, 10, 14, 20, 28, 30, 50, 56, 84, 90, 98, 280 or 500 tablets.
Danish: LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE) 7, 10, 14, 20, 28, 30, 50, 56, 84, 90, 98, 280 eller 500 tabletter.
English: Each Cozaar 100 mg tablet contains 51.0 mg lactose monohydrate.
Danish: Hver Cozaar 100 mg tablet indeholder 51,0 mg lactosemonohydrat.
English: PHARMACEUTICAL FORM AND CONTENTS 7, 10, 14, 15, 20, 28, 30, 50, 56, 84, 90, 98, or 280 tablets.
Danish: LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE) 7, 10, 14, 15, 20, 28, 30, 50, 56, 84, 90, 98 eller 280 tabletter.
English: Use in patients with intravascular volume depletion:
Danish: Patienter med intravaskulær væskemangel
English: It is not recommended in children with glomerular filtration rate < 30 ml/ min / 1.73 m2, as no data are available (see also section 4.4).
Danish: Losartan anbefales ikke til børn med en glomerulær filtrationsrate < 30 ml/min/1,73 m2, da der ikke foreligger data herfor (se også afsnit 4.4).
English: Film-coated tablets
Danish: Filmovertrukken tablet
English: White, teardrop-shaped film-coated tablets marked 960 on one side and plain on the other.
Danish: Cozaar 100 mg tablet Hvide, dråbeformede filmovertrukne tabletter mærket 960 på den ene side og glatte på den anden side.
English: Cozaar film-coated tablets losartan potassium
Danish: Cozaar filmovertrukne tabletter losartankalium
English: Cozaar 12.5 mg - PVC/PE/PVDC blister packages with aluminum foil lidding in packs of 7, 14, 21, 28, 50, 98, 210 or 500 tablets.
Danish: Cozaar 12,5 mg - PVC/PE/PVDC blisterpakninger med aluminiumsfolie i pakninger à 7, 14, 21, 28, 50, 98, 210 eller 500 tabletter.
English: • muscle and joint pain,
Danish: • Muskel- eller ledsmerter
English: General disorders and administration site conditions: common: asthenia/fatigue
Danish: Almene symptomer og reaktioner på administrationsstedet Almindelig: Asteni/træthed.
English: Ireland Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Herts EN11 9BU
Danish: Storbritannien Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Herts EN11 9BU, Storbritannien
English: Use in pediatric patients with renal function impairment Losartan is not recommended in children with glomerular filtration rate < 30ml/ min/ 1.73 m2as no data are available (see section 4.2).
Danish: Anvendelse til pædiatriske patienter med nyreinsufficiens Losartan bør ikke gives til børn med glomerulær filtrationshastighed <30 ml/min/1,73m2, da der ikke findes dokumentation herfor (se pkt.
English: Each Cozaar 12.5 mg Tablet contains 12.5 mg of losartan (as potassium salt).
Danish: Hver Cozaar 12,5 mg tablet indeholder 12,5 mg losartan (som kaliumsalt).
English: • localised swelling (oedema).
Danish: • Lokal hævelse (ødem).
English: 2nd and 3rd trimester of pregnancy (see section 4.4 and 4.6) Lactation (see section 4.6)
Danish: 2. og 3 trimester af graviditeten (se pkt.
English: • medicines which retain potassium or may increase potassium levels (e.g. potassium supplements, potassium-containing salt substitutes or potassium-sparing medicines such as certain diuretics [amiloride, triamteren, spironolactone] or heparine),
Danish: salterstatninger, der indeholder kalium eller kaliumbesparende medicin som visse vanddrivende lægemidler [amilorid, triamteren, spironolacton] eller heparin).
English: The CHMP was concerned that the benefit/risk ratio of this indication could not be adequately established.
Danish: CHMP var betænkelig ved, at benefit/risk-forholdet for denne indikation ikke kunne fastlægges på passende vis. Indikationen er primært baseret på resultaterne af de kliniske undersøgelser ELITE I og II.
English: HOW TO STORE Cozaar
Danish: SÅDAN OPBEVARER DE COZAAR
English: • nausea,
Danish: • Kvalme
English: • hives (urticaria),
Danish: • Nældefeber (urticaria)
English: • If you have any further questions, ask your doctor or your pharmacist.
Danish: • Spørg lægen eller på apoteket, hvis der er mere, De vil vide.
English: Gastrointestinal disorders: not known: diarrhoea
Danish: Mave-tarmkanalen Ikke kendt: Diarré.
English: • This medicine has been prescribed for you.
Danish: • Lægen har ordineret Cozaar til Dem personligt.
English: 751 Patients were treated with Losartan The objective of the study was to demonstrate a nephroprotective effect of Losartan potassium over and above the benefit of a blood lowering pressure.
Danish: Målet med undersøgelsen var at vise losartankaliums nyrebeskyttende virkning ud over dets gavnlige indvirkning på blodtrykket.
English: Immune system disorders: rare: hypersensitivity: anaphylactic reactions, angiooedema including swelling of the larynx and glottis causing airway obstruction and/or swelling of the face, lips, pharynx, and/or tongue; in some of these patients angiooedema had been reported in the past in connection with the administration of other medicines, including ACE inhibitors; vasculitis, including Henoch-Schonlein purpura.
Danish: Sjælden: Hypersensitivitet: Anafylaktiske reaktioner, angioødem inklusive hævelse af larynx og glottis, som medfører luftvejsobstruktion og/eller hævelse af ansigt, læber, svælg og/eller tunge.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each Cozaar 12.5 mg film-coated mg tablet contains 12.5 mg losartan potassium.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver Cozaar 12,5 mg filmovertrukken tablet indeholder 12,5 mg losartankalium Hver Cozaar 50 mg filmovertrukken tablet indeholder 50 mg losartankalium.
English: Blue, oval film-coated tablets marked 11 on one side and plain on the other.
Danish: Cozaar 12,5 mg tablet Blå, ovale, filmovertrukne tabletter mærket 11 på den ene side og glatte på den anden side.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister for Cozaar 12.5 mg film-coated tablets
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTERKORT ELLER BLISTERSTRIPS Blister til Cozaar 12,5 mg filmovertrukne tabletter
English: Luxembourg Merck Sharp & Dohme BVChaussée de Waterloo 1135
Danish: Luxemburg Merck Sharp & Dohme BVChaussée de Waterloo 1135 - B1180 Brussels, Belgien
English: Each Cozaar 25 mg Tablet contains 25 mg of losartan (as potassium salt).
Danish: Hver Cozaar 25 mg tablet indeholder 25 mg losartan (som kaliumsalt).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton for Cozaar 12.5 mg and 50 mg (titration package blister)
Danish: Ydre karton for Cozaar 12,5 mg og 50 mg (startpakke)
English: Each Cozaar 100 mg tablet contains 100 mg of losartan potassium.
Danish: Hver Cozaar 100 mg tablet indeholder 100 mg losartankalium.
English: Cozaar is supplied as unscored film-coated tablets containing 25 mg of losartan potassium.
Danish: Cozaar fås som filmovertrukne tab1etter uden delekærv indeholdende 25 mg losartankalium.
English: There is no therapeutic experience in patients with severe hepatic impairment.
Danish: Der er ikke erfaring med behandling til patienter med svær leverinsufficiens.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Bottle label for Cozaar 12.5 mg HDPE bottle
Danish: MINDSTEKRAV TIL MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Flaskeetiket til Cozaar 12,5 mg HDPE-flaske
English: Each Cozaar 50 mg Tablet contains 50 mg of losartan (as potassium salt).
Danish: Hver Cozaar 50 mg tablet indeholder 50 mg losartan (som kaliumsalt).
English: The Cozaar 12.5 mg tablets also may contain carnauba wax (E903), titanium dioxide (E171), indigo carmine (E132) aluminum lake.
Danish: Cozaar 12,5 mg tabletter kan også indeholde carnaubavoks (E903), titandioxid (E171), indigocarmin (E132).
English: Cozaar is supplied as unscored film-coated tablets containing 100 mg of losartan potassium.
Danish: Cozaar fås som filmovertrukne tab1etter uden delekærv indeholdende 100 mg losartankalium.
English: Member State Invented name
Danish: Særnavn
English: MARKETING AUTHORISATION HOLDER [To be implemented nationally]
Danish: INDEHAVER AF MARKEDSFØRINGSTILLADELSEN [Udfyldes nationalt]
English: • Reduction in the risk of stroke in hypertensive patients with left ventricular hypertrophy documented by ECG (see section 5.1 LIFE study, Race).
Danish: • Reduktion af risiko for stroke hos hypertensive patienter med hypertrofi af venstre ventrikel, som er dokumenteret ved EKG (se pkt.
English: Each Cozaar 50 mg tablet contains 25.5 mg lactose monohydrate.
Danish: Hver Cozaar 50 mg tablet indeholder 25,5 mg lactosemonohydrat.
English: Route of administration
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E)
English: Cozaar is supplied as scored film-coated tablets containing 50 mg of losartan potassium.
Danish: Cozaar fås som filmovertrukne tab1etter med delekærv indeholdende 50 mg losartankalium.
English: General disorders and administration site conditions: uncommon: asthenia/fatigue
Danish: Almene symptomer og reaktioner på administrationsstedet Ikke almindelig: Asteni/træthed.
English: Cozaar Startpakke
Danish: COZAAR CARDIO START
English: Each Cozaar 12,5 mg tablet contains 25.5 mg lactose monohydrate.
Danish: Hver Cozaar 12,5 mg tablet indeholder 25,5 mg lactosemonohydrat.
English: Each Cozaar 100 mg Tablet contains 91 100 mg of losartan (as potassium salt).
Danish: Hver Cozaar 100 mg tablet indeholder 100 mg losartan (som kaliumsalt).
English: Each Cozaar 12.5 mg tablet contains 12.5 mg of losartan potassium.
Danish: Hver Cozaar 12,5 mg tablet indeholder 12,5 mg losartankalium.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister for Cozaar 100 mg film-coated tablets
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTERKORT ELLER BLISTERSTRIPS Blister til Cozaar 100 mg filmovertrukne tabletter
English: Each Cozaar 25 mg tablet contains 25 mg of losartan potassium.
Danish: Hver Cozaar 25 mg tablet indeholder 25 mg losartankalium.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister for Cozaar 25 mg film-coated tablets
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTERKORT ELLER BLISTERSTRIPS Blister til Cozaar 25 mg filmovertrukne tabletter
English: What Cozaar looks like and contents of the pack Cozaar is supplied as unscored film-coated tablets containing 12.5 mg of losartan potassium.
Danish: Cozaar fås som filmovertrukne tab1etter uden delekærv indeholdende 12,5 mg losartankalium.
English: Each Cozaar 25 mg tablet contains12.75 mg lactose monohydrate.
Danish: Hver Cozaar 25 mg tablet indeholder 12,75 mg lactosemonohydrat.
English: Cozaar 50 mg - PVC/PE/PVDC blister packages with aluminum foil lidding in packs of 7, 10, 14, 20, 28, 30, 50, 56, 84, 90, 98, 280 or 500 tablets.
Danish: Cozaar 50 mg - PVC/PE/PVDC blisterpakninger med aluminiumsfolie i pakninger à 7, 10, 14, 20, 28, 30, 50, 56, 84, 90, 98, 280 eller 500 tabletter.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Bottle label for Cozaar 50 mg HDPE bottle
Danish: MINDSTEKRAV TIL MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Flaskeetiket til Cozaar 50 mg HDPE-flaske
English: Each Cozaar 50 mg tablet contains 50 mg of losartan potassium.
Danish: Hver Cozaar 50 mg tablet indeholder 50 mg losartankalium.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Bottle label for Cozaar 100 mg HDPE Bottle
Danish: MINDSTEKRAV TIL MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Ydre karton for Cozaar 100 mg HDPE-flaske
English: Muscoskeletal and connective tissue disorders:
Danish: Hypotension og elektrolyt-/væskeforstyrrelser:
English: Cosaar 100 mg - Filmtabletten 100 mg
Danish: Cosaar 100 mg - Filmtabletten
English: Cozaar 100 mg - PVC/PE/PVDC blister packages with aluminum foil lidding in packs of 7, 10, 14, 15, 20, 28, 30, 50, 56, 84, 90, 98 or 280 tablets.
Danish: Cozaar 100 mg - PVC/PE/PVDC blisterpakninger med aluminiumsfolie i pakninger à 7, 10, 14, 15, 20, 28, 30, 50, 56, 84, 90, 98 eller 280 tabletter.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton for Cozaar 12.5 mg HDPE bottle
Danish: MINDSTEKRAV TIL MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Ydre karton for Cozaar 12,5 mg HDPE-flaske
English: Cozaar and associated names (see Annex I) 12.5 mg film-coated tablets Cozaar and associated names (see Annex I) 25 mg film-coated tablets Cozaar and associated names (see Annex I) 50 mg film-coated tablets Cozaar and associated names (see Annex I) 100 mg film-coated tablets
Danish: Cozaar og tilhørende navne (Se bilag I) 25 mg filmovertrukne tabletter.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton for Cozaar 100 mg blister
Danish: Ydre karton for Cozaar 100 mg blister
English: You must not take losartan if you are breast-feeding.
Danish: De må ikke tage Cozaar, hvis De ammer.
English: Cozaar 100 mg - PVC/PE/PVDC blister packages with aluminum foil lidding in packs of 7, 10, 14, 15, 20, 28, 30, 50, 56, 90, 98 or 280 tablets.
Danish: Cozaar 100 mg - PVC/PE/PVDC blisterpakninger med aluminiumsfolie i pakninger à 7, 10, 14, 15, 20, 28, 30, 50, 56, 90, 98 eller 280 tabletter.
English: Uncommon:
Danish: Ikke almindelige:
English: Lactation
Danish: • Træthed
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister for Cozaar 50 mg film-coated tablets
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTERKORT ELLER BLISTERSTRIPS Blister til Cozaar 50 mg filmovertrukne tabletter
English: BEFORE YOU TAKE Cozaar
Danish: Hvis De har taget for meget Cozaar
English: Belgium Merck Sharp & Dohme BVChaussée de Waterloo 1135
Danish: Merck Sharp & Dohme BV - Chaussée de Waterloo 1135 - B-1180 Bruxelles, Belgien
English: The Cozaar 100 mg tablets also may contain Carnauba wax (E903), Titanium dioxide (E171).
Danish: Cozaar 100 mg tabletter kan også indeholde carnaubavoks (E903), titandioxid (E171).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton for Cozaar 50 mg blister
Danish: Ydre karton for Cozaar 50 mg blister
English: Muscoskeletal and connective tissue disorders: not known: back pain
Danish: Knogler, led, muskler og bindevæv Ikke kendt: Rygsmerter.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton for Cozaar 50 mg HDPE bottle
Danish: MINDSTEKRAV TIL MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Ydre karton for Cozaar 50 mg HDPE-flaske
English: Finland Merck Sharp & Dohme B.V. Waarderweg 39
Danish: Merck Sharp & Dohme B.V.
English: Therefore, losartan is contraindicated in patients with severe hepatic impairment (see sections 4.3 and 4.4).
Danish: Derfor er losartan kontraindiceret til patienter med svær leverinsufficiens (se pkt.
English: LORTAAN IC- Titulação 12.5 mg + 50 mg
Danish: Cozaar Startpakke 12,5 mg + 50 mg
English: The Cozaar 25 mg tablets also may contain Carnauba wax (E903), Titanium dioxide (E171).
Danish: Cozaar 25 mg tabletter kan også indeholde carnaubavoks (E903), titandioxid (E171).
English: In a clinical study conducted in type 2 diabetic patients with nephropathy, the incidence of hyperkalemia was higher in the group treated with Cozaar as compared to the placebo group (see section 4.8, 'Hypertension and type 2 diabetes with renal disease - Investigations' and ‘Post-marketing experience - Investigations' Therefore, the plasma concentrations of potassium as well as creatinine clearance values should be closely monitored, especially patients with heart failure and a Creatinine Clearance between 30-50 ml/ min should be closely monitored.
Danish: Derfor bør kaliums plasmakoncentration såvel som kreatininclearance monitoreres tæt, især patienter med hjertesvigt og kreatinin-clearance på 30-50 ml/min bør monitoreres tæt.
English: The Cozaar 50 mg tablets also may contain Carnauba wax (E903), Titanium dioxide (E171).
Danish: Cozaar 50 mg tabletter kan også indeholde carnaubavoks (E903), titandioxid (E171).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton for Cozaar 12.5 mg blister
Danish: Ydre karton for Cozaar 12,5 mg blister
English: White, oval unscored film-coated tablets marked 951 on one side and plain on the other.. Cozaar 50 mg tablet
Danish: Hvide, ovale filmovertrukne tabletter uden delekærv mærket 951 på den ene side og glatte på den anden side.
English: WEEK 3 (day 15-21) 1 tablet = 50 mg daily
Danish: 1 tablet = 50 mg dagligt
English: Hypertension and type 2 diabetes with renal disease In a controlled clinical trial in type 2 diabetic patients with proteinuria (RENAAL study, see section 5.1) the most common drug-related adverse events which were reported for losartan are as follows: Nervous system disorders: common: dizziness
Danish: I en kontrolleret klinisk undersøgelse med type 2-diabetikere med proteinuri (RENAAL-undersøgelse, se pkt.
English: Cozaar 12,5 mg tablet
Danish: COZAAR 12,5 mg 12,5 mg Filmovertrukken tablet
English: Cardiac disorders: rare: syncope, artrial fibrillation, cerebrovascular accident Vascular disorders: uncommon: hypotension, including orthostatic hypotension Respiratory, thoracic and mediastinal disorders: uncommon: dyspnoea
Danish: Vaskulære sygdomme Ikke almindelig: Hypotension, herunder orthostatisk hypotension.
English: NAME OF THE MEDICINAL PRODUCT Cozaar 12.5 mg film-coated tablets Cozaar 50 mg film-coated tablets
Danish: Cozaar 12,5 mg filmovertrukne tabletter Cozaar 50 mg filmovertrukne tabletter
English: How much and how often to take?
Danish: Hvor meget og hvor ofte skal man tage medicinen?
English: Not known (frequency cannot be estimated from available data)
Danish: Ikke kendte (hyppigheden kan ikke vurderes ud fra tilgængelige data)
English: See Vaccinations above.
Danish: Se vaccinationer ovenfor.
English: You will hear a loud click, which means the injection has started.
Danish: Du vil høre et højt klik, som betyder, at injektionen er startet.
English: Warning: Do not use the syringe if liquid contains particles, or is cloudy or if it is colored or has flakes in it.
Danish: Hvis du ikke har en affaldsbeholder til skarpe genstande, kan du bruge en beholder:
English: Absorption and distribution
Danish: Absorption og distribution
English: Open here
Danish: Åbnes her.
English: Note: With experience, you will find the angle (between 45° an 90°) that is most comfortable for you and the child.
Danish: Bemærk: Med erfaringen finder du den vinkel (mellem 45° og 90°), der er mest komfortabel for dig og barnet.
English: Maintenance dose starting at week 4
Danish: Vedligeholdelsesdosis startende ved uge 4
English: The primary non-responders were excluded from the studies and therefore these patients were not further evaluated.
Danish: De primære nonresponders blev ekskluderet fra studierne, og derfor blev disse patienter ikke yderligere undersøgt.
English: Check components to make sure that the packaging and the content are not damaged.
Danish: Tjek delene for at sikre dig, at emballage og indhold ikke er beskadiget.
English: This is to remove any air gaps or bubbles.
Danish: Det er for at fjerne eventuelle lufthuller eller bobler.
English: • Upright and stable during use,
Danish: • der står opret og stabilt under brug,
English: Minimum, median and maximum dose
Danish: Minimums-, median- og maksimumsdosis
English: 1.2 You will also need (Figure A):
Danish: 1.2 Du skal også bruge (figur A):
English: • You did not inject the full dose or
Danish: • hvis du ikke har injiceret hele dosen, eller
English: Note : images for illustration purposes only.
Danish: Bemærk: Billeder kun til illustration.
English: Kromeya can also be given alone.
Danish: Kromeya kan også tages alene.
English: Label area (Kromeya, dose, expiration date)
Danish: Etiketområde (Kromeya, dosis, udløbsdato)
English: Important Information
Danish: Vigtig information
English: Results from the overall UC-II study population are shown in Table 26.
Danish: Resultater fra den samlede UC-II studiespopulation er vist i tabel 26.
English: Gather supplies and check for damages
Danish: Saml alle dele og check for skader
English: Week 8 and 52
Danish: Uge 8 og 52
English: BCVA was either improved or maintained (< 5 letters deterioration) in 88.4% of the eyes at week 78.
Danish: BCVA blev enten forbedret eller vedligeholdt (<5 forringelse i forhold til bogstaver) i 88,4% af øjnene i uge 78.
English: Clinical response (CR-100) was maintained in 102 and 233 patients, respectively.
Danish: Klinisk respons (CR-100) blev fastholdt hos henholdvis 102 og 233 patienter.
English: Percent change in total fingernail NAPSI (%)
Danish: Procent ændring i Total Fingernail NAPSI (%)
English: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Danish: Da der ikke foreligger undersøgelser vedrørende eventuelle uforligeligheder, må dette lægemiddel ikke blandes med andre lægemidler.
English: The interpretation of data may be impacted due to methodological limitations of the study, including small sample size and nonrandomized design.
Danish: Fortolkningen af data kan være påvirket af studiets metodoligiske begrænsninger, inklusive lille prøvegruppe og ikke-randomiseret design.
English: Step 2 Wash your hands
Danish: Trin 2 Vask dine hænder
English: 61352 Bad Homburg v.d.Höhe Germany
Danish: 61352 Bad Homburg v.d.Höhe Tyskland