natgillin/translations-raw huggingface dataset:
21 filmovertrukne tabletter à 12,5 mg og 14 filmovertrukne tabletter à 50 mg losartankalium.
21 film-coated tablets of 12.5 mg and 14 film-coated tablets of 50 mg losartan potassium.
Losartan anbefales ikke til børn med en glomerulær filtrationsrate < 30 ml/min/1,73 m2, da der ikke foreligger data herfor (se afsnit 4.2).
Losartan is not recommended in children with glomerular filtration rate < 30ml/ min/ 1.73 m2as no data are available (see section 4.2).
• Søvnighed
• somnolence,
Mave-tarmkanalen Ikke almindelig: Diarré, kvalme, opkastning.
Gastrointestinal disorders: uncommon: diarrhoea, nausea, vomiting
Medlemsstat Indehaver af markedsføringstilladelse
Marketing Authorisation Holder and Manufacturer
magnesiumstearat (E572), hydroxypropylcellulose (E463), hypromellose (E464).
The other ingredients are microcrystalline cellulose (E460), lactose monohydrate, pregelatinized maize starch, magnesium stearate (E572), hydroxypropyl cellulose (E463), hypromellose (E464).
Hvide, ovale filmovertrukne tabletter mærket 952 på den ene side og med delekærv på den anden side.
White, oval film-coated tablets marked 952 on one side and scored on the other.
Blister til Cozaar 12,5 mg filmovertrukne tabletter Blister til Cozaar 50 mg filmovertrukne tabletter
Blister for Cozaar 12.5 mg film-coated tablets Blister for Cozaar 50 mg film-coated tablets
Lactosemonohydrat.
Lactose monohydrate.
Losartan er en oralt aktiv angiotensin II (Ang-II)-receptorantagonist, der påvirker AT1-receptorundertypen.
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.
Hvis Deres nedsatte hjertefunktion er blevet stabiliseret med ACE-hæmmere, behøver De ikke at skifte til Cozaar;
If your heart failure has been stabilised with an ACE inhibitor you should not be switched to losartan .
DATO FOR ÆNDRING AF TEKSTEN
DATE OF REVISION OF THE TEXT {MM/YYYY}
Behandlingen starter normalt med 12,5 mg losartan (en tablet Cozaar 12,5 mg) én gang dagligt.
Patients with Heart Failure Treatment usually starts with 12.5 mg losartan (one tablet Cozaar 12.5 mg) once a day.
Hver tablet indeholder følgende inaktive indholdsstoffer: Mikrokrystallinsk cellulose (E460) Lactosemonohydrat
Each tablet contains the following inactive ingredients: microcrystalline cellulose (E460) lactose monohydrate pregelatinized maize starch magnesium stearate (E572) hydroxypropyl cellulose (E463) hypromellose (E464)
LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE) 100 filmovertrukne tabletter.
PHARMACEUTICAL FORM AND CONTENTS 100 film-coated tablets.
LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE) 100 tabletter.
PHARMACEUTICAL FORM AND CONTENTS 100 tablets.
• Blodtryksfald, der viser sig, når man rejser sig fra liggende eller siddende stilling, og som kan have forbindelse til størrelsen af dosis
• dose-related orthostatic effects such as lowering of blood pressure appearing when rising from a lying or sitting position,
Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Herts EN11 9BU, Storbritannien
Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Herts EN11 9BU
Følgende bivirkninger forekom oftere hos patienter, der fik losartan end placebo:
The following adverse events occurred more often in patients receiving losartan than placebo: Blood and lymphatic system disorders: not known: anaemia
Merck Sharp & Dohme GmbH Donau-City-Straße 6, 1220 Wien, Østrig
Merck Sharp & Dohme GmbH Donau-City-Straße 6
Følgende ordlyd er tilføjet indlægssedlen, afsnit 2 Vigtig information som De skal læse, før De tager COZAAR:
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.
SÅDAN SKAL DE TAGE COZAAR
HOW TO TAKE Cozaar
LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE) 7, 10, 14, 20, 28, 30, 50, 56, 84, 90, 98, 280 eller 500 tabletter.
PHARMACEUTICAL FORM AND CONTENTS 7, 10, 14, 20, 28, 30, 50, 56, 84, 90, 98, 280 or 500 tablets.
Hver Cozaar 100 mg tablet indeholder 51,0 mg lactosemonohydrat.
Each Cozaar 100 mg tablet contains 51.0 mg lactose monohydrate.
LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE) 7, 10, 14, 15, 20, 28, 30, 50, 56, 84, 90, 98 eller 280 tabletter.
PHARMACEUTICAL FORM AND CONTENTS 7, 10, 14, 15, 20, 28, 30, 50, 56, 84, 90, 98, or 280 tablets.
Patienter med intravaskulær væskemangel
Use in patients with intravascular volume depletion:
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).
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).
Filmovertrukken tablet
Film-coated tablets
Cozaar 100 mg tablet Hvide, dråbeformede filmovertrukne tabletter mærket 960 på den ene side og glatte på den anden side.
White, teardrop-shaped film-coated tablets marked 960 on one side and plain on the other.
Cozaar filmovertrukne tabletter losartankalium
Cozaar film-coated tablets losartan potassium
Cozaar 12,5 mg - PVC/PE/PVDC blisterpakninger med aluminiumsfolie i pakninger à 7, 14, 21, 28, 50, 98, 210 eller 500 tabletter.
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.
• Muskel- eller ledsmerter
• muscle and joint pain,
Almene symptomer og reaktioner på administrationsstedet Almindelig: Asteni/træthed.
General disorders and administration site conditions: common: asthenia/fatigue
Storbritannien Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Herts EN11 9BU, Storbritannien
Ireland Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Herts EN11 9BU
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.
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).
Hver Cozaar 12,5 mg tablet indeholder 12,5 mg losartan (som kaliumsalt).
Each Cozaar 12.5 mg Tablet contains 12.5 mg of losartan (as potassium salt).
• Lokal hævelse (ødem).
• localised swelling (oedema).
2. og 3 trimester af graviditeten (se pkt.
2nd and 3rd trimester of pregnancy (see section 4.4 and 4.6) Lactation (see section 4.6)
salterstatninger, der indeholder kalium eller kaliumbesparende medicin som visse vanddrivende lægemidler [amilorid, triamteren, spironolacton] eller heparin).
• 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),
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.
The CHMP was concerned that the benefit/risk ratio of this indication could not be adequately established.
SÅDAN OPBEVARER DE COZAAR
HOW TO STORE Cozaar
• Kvalme
• nausea,
• Nældefeber (urticaria)
• hives (urticaria),
• Spørg lægen eller på apoteket, hvis der er mere, De vil vide.
• If you have any further questions, ask your doctor or your pharmacist.
Mave-tarmkanalen Ikke kendt: Diarré.
Gastrointestinal disorders: not known: diarrhoea
• Lægen har ordineret Cozaar til Dem personligt.
• This medicine has been prescribed for you.
Målet med undersøgelsen var at vise losartankaliums nyrebeskyttende virkning ud over dets gavnlige indvirkning på blodtrykket.
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.
Sjælden: Hypersensitivitet: Anafylaktiske reaktioner, angioødem inklusive hævelse af larynx og glottis, som medfører luftvejsobstruktion og/eller hævelse af ansigt, læber, svælg og/eller tunge.
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.
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.
STATEMENT OF ACTIVE SUBSTANCE(S) Each Cozaar 12.5 mg film-coated mg tablet contains 12.5 mg losartan potassium.
Cozaar 12,5 mg tablet Blå, ovale, filmovertrukne tabletter mærket 11 på den ene side og glatte på den anden side.
Blue, oval film-coated tablets marked 11 on one side and plain on the other.
MINDSTEKRAV TIL MÆRKNING PÅ BLISTERKORT ELLER BLISTERSTRIPS Blister til Cozaar 12,5 mg filmovertrukne tabletter
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister for Cozaar 12.5 mg film-coated tablets
Luxemburg Merck Sharp & Dohme BVChaussée de Waterloo 1135 - B1180 Brussels, Belgien
Luxembourg Merck Sharp & Dohme BVChaussée de Waterloo 1135
Hver Cozaar 25 mg tablet indeholder 25 mg losartan (som kaliumsalt).
Each Cozaar 25 mg Tablet contains 25 mg of losartan (as potassium salt).
Ydre karton for Cozaar 12,5 mg og 50 mg (startpakke)
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton for Cozaar 12.5 mg and 50 mg (titration package blister)
Hver Cozaar 100 mg tablet indeholder 100 mg losartankalium.
Each Cozaar 100 mg tablet contains 100 mg of losartan potassium.
Cozaar fås som filmovertrukne tab1etter uden delekærv indeholdende 25 mg losartankalium.
Cozaar is supplied as unscored film-coated tablets containing 25 mg of losartan potassium.
Der er ikke erfaring med behandling til patienter med svær leverinsufficiens.
There is no therapeutic experience in patients with severe hepatic impairment.
MINDSTEKRAV TIL MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Flaskeetiket til Cozaar 12,5 mg HDPE-flaske
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Bottle label for Cozaar 12.5 mg HDPE bottle
Hver Cozaar 50 mg tablet indeholder 50 mg losartan (som kaliumsalt).
Each Cozaar 50 mg Tablet contains 50 mg of losartan (as potassium salt).
Cozaar 12,5 mg tabletter kan også indeholde carnaubavoks (E903), titandioxid (E171), indigocarmin (E132).
The Cozaar 12.5 mg tablets also may contain carnauba wax (E903), titanium dioxide (E171), indigo carmine (E132) aluminum lake.
Cozaar fås som filmovertrukne tab1etter uden delekærv indeholdende 100 mg losartankalium.
Cozaar is supplied as unscored film-coated tablets containing 100 mg of losartan potassium.
Særnavn
Member State Invented name
INDEHAVER AF MARKEDSFØRINGSTILLADELSEN [Udfyldes nationalt]
MARKETING AUTHORISATION HOLDER [To be implemented nationally]
• Reduktion af risiko for stroke hos hypertensive patienter med hypertrofi af venstre ventrikel, som er dokumenteret ved EKG (se pkt.
• Reduction in the risk of stroke in hypertensive patients with left ventricular hypertrophy documented by ECG (see section 5.1 LIFE study, Race).
Hver Cozaar 50 mg tablet indeholder 25,5 mg lactosemonohydrat.
Each Cozaar 50 mg tablet contains 25.5 mg lactose monohydrate.
ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E)
Route of administration
Cozaar fås som filmovertrukne tab1etter med delekærv indeholdende 50 mg losartankalium.
Cozaar is supplied as scored film-coated tablets containing 50 mg of losartan potassium.
Almene symptomer og reaktioner på administrationsstedet Ikke almindelig: Asteni/træthed.
General disorders and administration site conditions: uncommon: asthenia/fatigue
COZAAR CARDIO START
Cozaar Startpakke
Hver Cozaar 12,5 mg tablet indeholder 25,5 mg lactosemonohydrat.
Each Cozaar 12,5 mg tablet contains 25.5 mg lactose monohydrate.
Hver Cozaar 100 mg tablet indeholder 100 mg losartan (som kaliumsalt).
Each Cozaar 100 mg Tablet contains 91 100 mg of losartan (as potassium salt).
Hver Cozaar 12,5 mg tablet indeholder 12,5 mg losartankalium.
Each Cozaar 12.5 mg tablet contains 12.5 mg of losartan potassium.
MINDSTEKRAV TIL MÆRKNING PÅ BLISTERKORT ELLER BLISTERSTRIPS Blister til Cozaar 100 mg filmovertrukne tabletter
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister for Cozaar 100 mg film-coated tablets
Hver Cozaar 25 mg tablet indeholder 25 mg losartankalium.
Each Cozaar 25 mg tablet contains 25 mg of losartan potassium.
MINDSTEKRAV TIL MÆRKNING PÅ BLISTERKORT ELLER BLISTERSTRIPS Blister til Cozaar 25 mg filmovertrukne tabletter
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister for Cozaar 25 mg film-coated tablets
Cozaar fås som filmovertrukne tab1etter uden delekærv indeholdende 12,5 mg losartankalium.
What Cozaar looks like and contents of the pack Cozaar is supplied as unscored film-coated tablets containing 12.5 mg of losartan potassium.
Hver Cozaar 25 mg tablet indeholder 12,75 mg lactosemonohydrat.
Each Cozaar 25 mg tablet contains12.75 mg lactose monohydrate.
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.
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.
MINDSTEKRAV TIL MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Flaskeetiket til Cozaar 50 mg HDPE-flaske
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Bottle label for Cozaar 50 mg HDPE bottle
Hver Cozaar 50 mg tablet indeholder 50 mg losartankalium.
Each Cozaar 50 mg tablet contains 50 mg of losartan potassium.
MINDSTEKRAV TIL MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Ydre karton for Cozaar 100 mg HDPE-flaske
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Bottle label for Cozaar 100 mg HDPE Bottle
Hypotension og elektrolyt-/væskeforstyrrelser:
Muscoskeletal and connective tissue disorders:
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.
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.
MINDSTEKRAV TIL MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Ydre karton for Cozaar 12,5 mg HDPE-flaske
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton for Cozaar 12.5 mg HDPE bottle
Cozaar og tilhørende navne (Se bilag I) 25 mg filmovertrukne tabletter.
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
Ydre karton for Cozaar 100 mg blister
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton for Cozaar 100 mg blister
De må ikke tage Cozaar, hvis De ammer.
You must not take losartan if you are breast-feeding.
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.
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.
Ikke almindelige:
Uncommon:
• Træthed
Lactation
MINDSTEKRAV TIL MÆRKNING PÅ BLISTERKORT ELLER BLISTERSTRIPS Blister til Cozaar 50 mg filmovertrukne tabletter
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister for Cozaar 50 mg film-coated tablets
Hvis De har taget for meget Cozaar
BEFORE YOU TAKE Cozaar
Merck Sharp & Dohme BV - Chaussée de Waterloo 1135 - B-1180 Bruxelles, Belgien
Belgium Merck Sharp & Dohme BVChaussée de Waterloo 1135
Cozaar 100 mg tabletter kan også indeholde carnaubavoks (E903), titandioxid (E171).
The Cozaar 100 mg tablets also may contain Carnauba wax (E903), Titanium dioxide (E171).
Ydre karton for Cozaar 50 mg blister
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton for Cozaar 50 mg blister
Knogler, led, muskler og bindevæv Ikke kendt: Rygsmerter.
Muscoskeletal and connective tissue disorders: not known: back pain
MINDSTEKRAV TIL MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Ydre karton for Cozaar 50 mg HDPE-flaske
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton for Cozaar 50 mg HDPE bottle
Derfor er losartan kontraindiceret til patienter med svær leverinsufficiens (se pkt.
Therefore, losartan is contraindicated in patients with severe hepatic impairment (see sections 4.3 and 4.4).
Cozaar Startpakke 12,5 mg + 50 mg
LORTAAN IC- Titulação 12.5 mg + 50 mg
Cozaar 25 mg tabletter kan også indeholde carnaubavoks (E903), titandioxid (E171).
The Cozaar 25 mg tablets also may contain Carnauba wax (E903), Titanium dioxide (E171).
Derfor bør kaliums plasmakoncentration såvel som kreatininclearance monitoreres tæt, især patienter med hjertesvigt og kreatinin-clearance på 30-50 ml/min bør monitoreres tæt.
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.
Cozaar 50 mg tabletter kan også indeholde carnaubavoks (E903), titandioxid (E171).
The Cozaar 50 mg tablets also may contain Carnauba wax (E903), Titanium dioxide (E171).
Ydre karton for Cozaar 12,5 mg blister
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton for Cozaar 12.5 mg blister
Hvide, ovale filmovertrukne tabletter uden delekærv mærket 951 på den ene side og glatte på den anden side.
White, oval unscored film-coated tablets marked 951 on one side and plain on the other.. Cozaar 50 mg tablet
1 tablet = 50 mg dagligt
WEEK 3 (day 15-21) 1 tablet = 50 mg daily
I en kontrolleret klinisk undersøgelse med type 2-diabetikere med proteinuri (RENAAL-undersøgelse, se pkt.
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
COZAAR 12,5 mg 12,5 mg Filmovertrukken tablet
Cozaar 12,5 mg tablet
Vaskulære sygdomme Ikke almindelig: Hypotension, herunder orthostatisk hypotension.
Cardiac disorders: rare: syncope, artrial fibrillation, cerebrovascular accident Vascular disorders: uncommon: hypotension, including orthostatic hypotension Respiratory, thoracic and mediastinal disorders: uncommon: dyspnoea
Cozaar 12,5 mg filmovertrukne tabletter Cozaar 50 mg filmovertrukne tabletter
NAME OF THE MEDICINAL PRODUCT Cozaar 12.5 mg film-coated tablets Cozaar 50 mg film-coated tablets
Hvor meget og hvor ofte skal man tage medicinen?
How much and how often to take?
Ikke kendte (hyppigheden kan ikke vurderes ud fra tilgængelige data)
Not known (frequency cannot be estimated from available data)
Se vaccinationer ovenfor.
See Vaccinations above.
Du vil høre et højt klik, som betyder, at injektionen er startet.
You will hear a loud click, which means the injection has started.
Hvis du ikke har en affaldsbeholder til skarpe genstande, kan du bruge en beholder:
Warning: Do not use the syringe if liquid contains particles, or is cloudy or if it is colored or has flakes in it.
Absorption og distribution
Absorption and distribution
Åbnes her.
Open here
Bemærk: Med erfaringen finder du den vinkel (mellem 45° og 90°), der er mest komfortabel for dig og barnet.
Note: With experience, you will find the angle (between 45° an 90°) that is most comfortable for you and the child.
Vedligeholdelsesdosis startende ved uge 4
Maintenance dose starting at week 4
De primære nonresponders blev ekskluderet fra studierne, og derfor blev disse patienter ikke yderligere undersøgt.
The primary non-responders were excluded from the studies and therefore these patients were not further evaluated.
Tjek delene for at sikre dig, at emballage og indhold ikke er beskadiget.
Check components to make sure that the packaging and the content are not damaged.
Det er for at fjerne eventuelle lufthuller eller bobler.
This is to remove any air gaps or bubbles.
• der står opret og stabilt under brug,
• Upright and stable during use,
Minimums-, median- og maksimumsdosis
Minimum, median and maximum dose
1.2 Du skal også bruge (figur A):
1.2 You will also need (Figure A):
• hvis du ikke har injiceret hele dosen, eller
• You did not inject the full dose or
Bemærk: Billeder kun til illustration.
Note : images for illustration purposes only.
Kromeya kan også tages alene.
Kromeya can also be given alone.
Etiketområde (Kromeya, dosis, udløbsdato)
Label area (Kromeya, dose, expiration date)
Vigtig information
Important Information
Resultater fra den samlede UC-II studiespopulation er vist i tabel 26.
Results from the overall UC-II study population are shown in Table 26.
Saml alle dele og check for skader
Gather supplies and check for damages
Uge 8 og 52
Week 8 and 52
BCVA blev enten forbedret eller vedligeholdt (<5 forringelse i forhold til bogstaver) i 88,4% af øjnene i uge 78.
BCVA was either improved or maintained (< 5 letters deterioration) in 88.4% of the eyes at week 78.
Klinisk respons (CR-100) blev fastholdt hos henholdvis 102 og 233 patienter.
Clinical response (CR-100) was maintained in 102 and 233 patients, respectively.
Procent ændring i Total Fingernail NAPSI (%)
Percent change in total fingernail NAPSI (%)
Da der ikke foreligger undersøgelser vedrørende eventuelle uforligeligheder, må dette lægemiddel ikke blandes med andre lægemidler.
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Fortolkningen af data kan være påvirket af studiets metodoligiske begrænsninger, inklusive lille prøvegruppe og ikke-randomiseret design.
The interpretation of data may be impacted due to methodological limitations of the study, including small sample size and nonrandomized design.
Trin 2 Vask dine hænder
Step 2 Wash your hands
61352 Bad Homburg v.d.Höhe Tyskland
61352 Bad Homburg v.d.Höhe Germany
Patienter, som oplever utilstrækkeligt respons, kan have fordel af at øge dosis til:
Patients who experience insufficient response may benefit from an increase in dosage:
I RA-studie III holdt disse forbedringer sig i 52 uger.
In RA study III, these improvements were maintained throughout 52 weeks.
Succursale de Corsier-sur-Vevey Chemin du Fenil Zone Industrielle B 1804 Corsier-sur-Vevey Schweiz
Succursale de Corsier-sur-Vevey Chemin du Fenil Zone Industrielle B 1804 Corsier-sur-Vevey Switzerland
Kromeya er tilgængelig i andre præsentationer.
Kromeya is available in other presentations.
Kontakt lægen så hurtigt som muligt, hvis du oplever noget af følgende:
Tell your doctor as soon as possible, if you notice any of the following:
Giv langsomt slip med tommelfingeren.
Slowly release your thumb up.
I sjældne tilfælde kan disse infektioner være livstruende.
In rare cases, these infections may be lifethreatening.
Patient vægt
Patient weight
Nogle bivirkninger, som er set med adalimumab, har ikke symptomer og kan kun opdages ved blodprøver.
Some side effects observed with adalimumab may not have symptoms and may only be discovered through blood tests.
Bemærk dog, at Kromeya ikke er beregnet eller godkendt til behandling af hidrosadenitis suppurativa.
However, please note that Kromeya is neither intended nor authorized for treatment of hidradenitis suppurativa.
Søg straks lægehjælp, hvis du får følgende tegn på en allergisk reaktion eller hjertesvigt:
Seek medical attention urgently, if you notice any of the following signs of allergic reaction or heart failure:
PGA-F clear/minimal og ≥2-grade forbedring (%)
PGA-F clear/minimal and ≥2-grade improvement (%)
1.4 Du skal også bruge følgende, som ikke indgår i sættet:
1.4 You will also need following supplies that are not included in the kit: