FrancophonIA/ELRC3.0 huggingface dataset:
English: Thromboembolis hypotension10
Danish: Ortostatisk hypotension10
English: Aluminium/aluminium blisters in cartons of 28, 35, 56, 70 and 98 tablets per carton.
Danish: Aluminium/aluminium blisterkort i kartoner a 28, 35, 56, 70 eller 98 tabletter pr. karton.
English: Olanzapine Glenmark 7.5 mg: yellow coloured circular flat bevelled edge tablets with ‘C' debossed on one side.
Danish: Olanzapine Glenmark 7,5 mg leveres som gule, cirkulære tabletter med flad afrundet kant med 'C' præget på den ene side.
English: NAME OF THE MARKETING AUTHORISATION HOLDER Glenmark Arzneimittel GmbH
Danish: NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Glenmark Arzneimittel GmbH
English: Aluminium/aluminium blisters in cartons of 28, 56, 70, 98 tablets per carton.
Danish: Aluminium/aluminium blisterkort i kartoner a 28, 56, 70 eller 98 tabletter pr. karton.
English: • Dizziness.
Danish: • Forstoppelse.
English: Olanzapine Glenmark 7.5 mg tablets
Danish: Olanzapine Glenmark 7,5 mg tabletter
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 7.5 mg olanzapine.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver tablet indeholder 7,5 mg olanzapin
English: Blood and the lymphatic system disorders Eosinophilia
Danish: Blod og lymfesystem Eosinofili Leukopeni10 Neutropeni10
English: If you forget to take Olanzapine Glenmark Take your tablets as soon as you remember.
Danish: Hvis du har glemt at tage Olanzapine Glenmark Du må ikke tage en dobbeltdosis som erstatning for den glemte dosis.
English: Olanzapine Glenmark 10 mg tablets
Danish: Olanzapine Glenmark 10 mg tabletter
English: 3 Observed for fasting normal levels at baseline (< 5.17 mmol/l) which increased to high (≥ 6.2
Danish: 3Observeret for fastende normalt niveau ved baseline (< 5,17 mmol/l), der blev øget til højt niveau (≥ 6,2 mmol/l).
English: Olanzapine Glenmark 2.5 mg tablets
Danish: Olanzapine Glenmark 2,5 mg tabletter
English: • Memory loss or forgetfulness
Danish: • Næseblod; udspilet mave; hukommelsestab eller glemsomhed
English: Olanzapine Glenmark 20 mg: yellow coloured circular flat bevelled edge tablets with ‘OL' debossed on one side and ‘F' debossed on other side.
Danish: Olanzapine Glenmark 20 mg leveres som gule, cirkulære tabletter med flad afrundet kant med 'OL' præget på den ene side og 'F' præget på den anden side.
English: Olanzapine Glenmark 15 mg tablets
Danish: Olanzapine Glenmark 15 mg tabletter
English: Olanzapine Glenmark 5 mg: yellow coloured circular flat bevelled edge tablets with ‘B' debossed on one side.
Danish: Olanzapine Glenmark 5 mg levers som gule, cirkulære tabletter med flad afrundet kant med 'B' præget på den ene side.
English: Dose escalation, when indicated, should be conservative in such patients (See sections 4.5 and 5.2).
Danish: Optrapning af dosis, når indiceret, bør hos sådanne patienter foretages med forsigtighed.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 7.5 mg olanzapine.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder 7,5 mg olanzapin
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 20 mg olanzapine
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder 20 mg olanzapin
English: Tablet Yellow coloured circular flat bevelled edge tablets with ‘A' debossed on one side.
Danish: Tablet Gule, cirkulære tabletter med flad afrundet kant med 'A' præget på den ene side.
English: Your doctor should do blood tests to check blood sugar and certain fat levels before you start taking Olanzapine Glenmark and regularly during treatment.
Danish: Inden du påbegynder behandling med Olanzapine Glenmark samt jævnligt i løbet af behandlingen skal din læge tage blodprøver for at kontrollere indholdet af sukker og fedt i dit blod,
English: Oedema Pyrexia10
Danish: Asteni Træthed Ødemer Pyreksi10
English: If you stop taking Olanzapine Glenmark
Danish: Tag ikke Olanzapine Glenmark
English: Dystonia (including oculogyration) 11
Danish: Dystoni (inklusive okulogyration)11 Tardiv dyskinesi11 Amnesi9
English: Tablet Yellow coloured circular flat bevelled edge tablets with ‘C' debossed on one side.
Danish: Tablet Gule, cirkulære tabletter med flad afrundet kant med 'C' præget på den ene side.
English: Temporal association of olanzapine treatment and venous thromboembolism has been reported uncommonly (≥ 0.1% and < 1%).
Danish: Venetrombose med en tidsmæssig sammenhæng med olanzapinbehandling er rapporteret med frekvensen "ikke almindelig" (≥ 1/1.000 til < 1/100).
English: Consult your doctor if your symptoms return but do not stop taking Olanzapine Glenmark unless your doctor tells you to.
Danish: Din læge vil fortælle dig, hvor mange Olanzapine Glenmark tabletter, du skal tage og i hvor lang tid, du skal tage dem. Dagsdosis for Olanzapine Glenmark er mellem 5 mg og 20 mg. Konsulter din læge, hvis dine symptomer vender tilbage, men stop ikke med at tage Olanzapine Glenmark medmindre, din læge siger det.
English: Olanzapine Glenmark 15 mg: yellow coloured circular flat bevelled edge tablets with ‘OL' debossed on one side and ‘E' debossed on other side.
Danish: Olanzapine Glenmark 15 mg leveres som gule, cirkulære tabletter med flad afrundet kant med 'OL' præget på den ene side og 'E' præget på den anden side.
English: Uncommon side effects (may affect up to 1 in 100 people) include:
Danish: Ikke almindelige bivirkninger (forekommer hos op til 1 ud af 100 patienter) omfatter
English: NAME OF THE MEDICINAL PRODUCT Olanzapine Glenmark 7.5 mg tablets
Danish: LÆGEMIDLETS NAVN Olanzapine Glenmark 7,5 mg tabletter
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 10 mg olanzapine.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver tablet indeholder 10 mg olanzapin
English: Urinary incontinence, urinary retention
Danish: • Ufrivillig vandladning (urininkontinens); vandladningsbesvær
English: Yellow coloured circular flat bevelled edge tablets with ‘OL' debossed on one side and ‘E' debossed on other side.
Danish: Gule, cirkulære tabletter med flad afrundet kant med 'OL' præget på den ene side og 'E' præget på den anden side.
English: • Stuttering
Danish: • Stammen
English: NAME OF THE MEDICINAL PRODUCT Olanzapine Glenmark 7.5 mg tablets Olanzapine
Danish: LÆGEMIDLETS NAVN Olanzapine Glenmark 7,5 mg tabletter Olanzapin
English: NAME OF THE MEDICINAL PRODUCT Olanzapine Glenmark 20 mg tablets
Danish: LÆGEMIDLETS NAVN Olanzapine Glenmark 20 mg tabletter
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 15 mg olanzapine.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver tablet indeholder 15 mg olanzapin
English: Excipient with known effect: Each tablet contains 0.23 mg of aspartame For the full list of excipients, see section 6.1.
Danish: Hver tablet indeholder 0,23 mg aspartam Alle hjælpestoffer er anført under pkt.6.1
English: Olanzapine Glenmark 10 mg: yellow coloured circular flat bevelled edge tablets with ‘OL' debossed on one side and ‘D' debossed on other side.
Danish: Olanzapine Glenmark 10 mg leveres som gule, cirkulære tabletter med flad afrundet kant med 'OL' præget på den ene side og 'D' præget på den anden side.
English: Excipient with known effect: Each tablet contains 0.46 mg of aspartame For the full list of excipients, see section 6.1.
Danish: Hver tablet indeholder 0,46 mg aspartam Alle hjælpestoffer er anført under pkt.6.1
English: NAME OF THE MEDICINAL PRODUCT Olanzapine Glenmark 20 mg tablets Olanzapine
Danish: LÆGEMIDLETS NAVN Olanzapine Glenmark 20 mg tabletter Olanzapin
English: NAME OF THE MEDICINAL PRODUCT Olanzapine Glenmark 2.5 mg tablets
Danish: LÆGEMIDLETS NAVN Olanzapine Glenmark 2,5 mg tabletter
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 2.5 mg olanzapine.
Danish: .ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder 2,5 mg olanzapin
English: Excipient with known effect: Each tablet contains 0.35 mg of aspartame For the full list of excipients, see section 6.1.
Danish: Hver tablet indeholder 0,35 mg aspartam Alle hjælpestoffer er anført under pkt.6.1
English: Excipient with known effect: Each tablet contains 0.69 mg of aspartame For the full list of excipients, see section 6.1.
Danish: Hver tablet indeholder 0,69 mg aspartam Alle hjælpestoffer er anført under pkt.6.1
English: In a multinational, double-blind, comparative study of schizophrenia, schizoaffective, and related disorders which included 1,481 patients with varying degrees of associated depressive symptoms (baseline mean of 16.6 on the Montgomery-Asberg Depression Rating Scale), a prospective secondary analysis of baseline to endpoint mood score change demonstrated a statistically significant\ improvement (p= 0.001) favouring olanzapine (- 6.0) versus haloperidol (- 3.1).
Danish: Studiet viste en prospektiv sekundær analyse af ændring i stemningslejeniveauet fra før behandling til endt behandling en statistisk signifikant forbedring (p=0,001) til fordel for patienter behandlet med olanzapin (-6,0) i forhold til patienter behandlet med haloperidol (-3,1).
English: What Olanzapine Glenmark looks like and contents of the pack Olanzapine Glenmark 2.5mg is supplied as: yellow coloured circular flat bevelled edge tablets with ‘A' debossed on one side.
Danish: Olanzapine Glenmark 2,5 mg leveres som gule, cirkulære tabletter med flad afrundet kant med 'A' præget på den ene side.
English: Common side effects (may affect up to 1 in 10 people) include:
Danish: Almindelige bivirkninger (forekommer hos op til 1 ud af 10 patienter) omfatter
English: NAME OF THE MEDICINAL PRODUCT Olanzapine Glenmark 10 mg tablets
Danish: LÆGEMIDLETS NAVN Olanzapine Glenmark 10 mg tabletter
English: NAME OF THE MEDICINAL PRODUCT Olanzapine Glenmark 2.5 mg tablets Olanzapine
Danish: LÆGEMIDLETS NAVN Olanzapine Glenmark 2,5 mg tabletter Olanzapin
English: Yellow coloured circular flat bevelled edge tablets with ‘OL' debossed on one side and ‘D' debossed on other side.
Danish: Gule, cirkulære tabletter med flad afrundet kant med 'OL' præget på den ene side og 'D' præget på den anden side.
English: NAME OF THE MEDICINAL PRODUCT Olanzapine Glenmark 15 mg tablets Olanzapine
Danish: LÆGEMIDLETS NAVN Olanzapine Glenmark 15 mg tabletter Olanzapin
English: DATE OF REVISION OF THE TEXT {MM/YYYY}
Danish: Oversigt over indlægssedlen:
English: NAME OF THE MEDICINAL PRODUCT Olanzapine Glenmark 15 mg tablets
Danish: LÆGEMIDLETS NAVN Olanzapine Glenmark 15 mg tabletter
English: • Abnormal rhythms of the heart.
Danish: • Unormal hjerterytme.
English: • Diabetes
Danish: • Krampeanfald
English: NAME OF THE MEDICINAL PRODUCT Olanzapine Glenmark 5 mg tablets
Danish: LÆGEMIDLETS NAVN Olanzapine Glenmark 5 mg tabletter
English: • Sleepiness
Danish: • Søvnighed.
English: Yellow coloured circular flat bevelled edge tablets with ‘B' debossed on one side.
Danish: Tablet Gule, cirkulære tabletter med flad afrundet kant med 'B' præget på den ene side.
English: Yellow coloured circular flat bevelled edge with ‘OL' debossed on one side and ‘F' debossed on other side.
Danish: Gule, cirkulære tabletter med flad afrundet kant med 'OL' præget på den ene side og 'F' præget på den anden side.
English: In a multinational, double-blind, comparative study of schizophrenia, schizoaffective, and related disorders which included 1,481 patients with varying degrees of associated depressive symptoms (baseline mean of 16.6 on the Montgomery-Asberg Depression Rating Scale), a prospective secondary analysis of baseline to endpoint mood score change demonstrated a statistically significant improvement (p= 0.001) favouring olanzapine (- 6.0) versus haloperidol (- 3.1).
Danish: Studiet omfattede 1481 patienter med varierende grad af hertil forbundne depressive symptomer (middelværdi før behandling lig 16,6 ved Montgomery-Asberg Depression Rating Scale).
English: If this happens after you have been given Olanzapine Glenmark tell your doctor.
Danish: Brug af anden medicin sammen med Olanzapine Glenmark Tag kun anden medicin sammen med Olanzapine Glenmark, hvis din læge siger, at du må.
English: Abdominal
Danish: Amning
English: • Hair loss.
Danish: • Hududslæt.
English: categories.
Danish: uger).
English: constipation and dry mouth
Danish: Nyrer og urinveje
English: Crospovidone Magnesium stearate
Danish: Mikrokrystallinsk cellulose
English: - Very rarely, medicines of this type cause a combination of fever, faster breathing, sweating, muscle stiffness and drowsiness or sleepiness.
Danish: Hvis dette forekommer, når du har taget Olanzapine Glenmark, skal du fortælle det til lægen.Yderst sjældent forårsager denne slags medicin en kombination af feber, hurtigere vejrtrækning, svedtendens, muskelstivhed og døsighed/søvnighed.
English: Investigations Elevated plasma Increased alkaline Increased total prolactin levels8
Danish: Forhøjede kolesterolniveauer2, Forhøjede glucoseniveauer 4 Forhøjede triglyceridniveauer Glukosuri Øget appetite
English: 6.5 Nature and contents of container Aluminium/aluminium blisters in cartons of 28, 56, 70, 98 tablets per carton.
Danish: 6.4 Særlige opbevaringsforhold Opbevares ved temperaturer under 30º C 6.5 Emballagetype og pakningsstørrelser Aluminium/aluminium blisterkort i kartoner a 28, 56, 70 eller 98 tabletter pr. karton.
English: NAME OF THE MEDICINAL PRODUCT Olanzapine Glenmark 10 mg tablets Olanzapine
Danish: LÆGEMIDLETS NAVN Olanzapine Glenmark 10 mg tabletter Olanzapin 2.
English: Keep this medicine out of sight and reach of children
Danish: Opbevar lægemidlet utilgængeligt for børn.
English: Cardiac disorders
Danish: Karcinogenicitet
English: Photosensitivity reaction Alopecia
Danish: Lysfølsomhedsrea ktion
English: No long-term outcome is available.
Danish: Langsigtede resultater foreligger ikke.
English: The required dose is determined using the following formula:
Danish: Den nødvendige dosis fastsættes ved brug af følgende formel:
English: Repeat every 12-24 hours.
Danish: Gentages for hver 12-24 timer.
English: SE-11276 Stockholm Sweden
Danish: SE-11276 Stockholm Sverige
English: Date of first authorisation: 13 April 1999 Date of latest renewal: 15 April 2014
Danish: Dato for første markedsføringstilladelse: 13. april 1999 Dato for seneste fornyelse: 15. april 2014
English: This is of importance particularly when changing the laboratory and/or reagents used.
Danish: Dette er især vigtigt, når laboratoriet og/eller de anvendte reagenser udskiftes.
English: Additional Instructions:
Danish: Supplerende instruktioner:
English: Always wash your hands before performing the following procedures.
Danish: Vask altid hænder, før De udfører følgende procedurer.
English: You must contact your doctor immediately if you have any of the following early symptoms of allergic reactions:
Danish: De skal straks kontakte Deres læge, hvis De oplever nogen af følgende tidlige symptomer på allergiske reaktioner:
English: Common to < 1/10
Danish: Almindelig til < 1/10
English: Other in-use storage times and conditions are the responsibility of the user.
Danish: Anden opbevaringstid og andre opbevaringsforhold er brugerens ansvar.
English: Clinical studies did not include subjects aged 65 and over.
Danish: Kliniske studier inkluderede ikke forsøgspersoner på 65 år og derover.
English: Chemical and physical in-use stability has been demonstrated for 3 hours at temperatures up to 25°C.
Danish: Der er påvist kemisk og fysisk stabilitet i brug i 3 timer ved temperaturer på op til 25°C.
English: Reports of lack of effect
Danish: Rapporter om manglende virkning
English: Do not attempt self-infusion unless properly trained.
Danish: Forsøg ikke at injicere selv, medmindre De er grundigt oplært.
English: If you have not used it within 3 hours, throw it away.
Danish: Hvis den ikke er blevet anvendt inden for 3 timer, skal den kasseres.
English: Patients or their carers can give injections of ReFacto AF, provided that they have been trained appropriately.
Danish: Patienter eller deres omsorgspersoner kan give injektioner af ReFacto AF, forudsat at de har fået passende instruktion.
English: Administration (Intravenous Infusion)
Danish: Administration (intravenøs infusion)
English: During your treatment, your doctor may decide to change the dose of ReFacto AF you receive.
Danish: Under behandlingen kan Deres læge beslutte at ændre den dosis ReFacto AF, som De modtager.
English: Every 24 hours, at least 1 day, until healing is achieved.
Danish: For hver 24 timer, mindst 1 dag, indtil heling er opnået.
English: Therefore, factor VIII should be used during pregnancy and breast-feeding only if clearly indicated.
Danish: Faktor VIII bør derfor kun anvendes under graviditet og amning, hvis det er klart indiceret.
English: Factor VIII level required (% or IU/dl)
Danish: Nødvendigt faktor VIII-niveau (% eller IE/dl)
English: Immune Tolerance Induction
Danish: Induktion af immuntolerans
English: In case of shock, standard medical treatment for shock should be implemented.
Danish: Ved chok skal den medicinske standardbehandling for chok anvendes.
English: All components used in the reconstitution and administration of this product should be used as soon as possible after opening their sterile containers, to minimise unnecessary exposure to the air.
Danish: Alle komponenter, der anvendes til tilberedning og administration af dette produkt, skal bruges så hurtigt som muligt efter åbning af deres sterile beholdere for at minimere unødvendig udsættelse for luft.
English: In some cases, especially in younger patients, shorter dose intervals or higher doses may be necessary.
Danish: I nogle tilfælde, især hos yngre patienter, kan kortere doseringsintervaller eller højere doser være nødvendige.
English: After cleaning, do not touch the rubber stopper with your hand or allow it to touch any surface.
Danish: Efter rensning må De ikke røre gummiproppen med hænderne eller lade den røre nogen overflade.
English: At least 1 day until the bleeding episode as indicated by pain is resolved or healing is achieved.
Danish: Mindst 1 dag, indtil blødningsepisoden som indikeret af smerte er afhjulpet, eller heling er opnået.
English: Frequencies have been evaluated according to the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10) and uncommon (≥ 1/1,000 to < 1/100).
Danish: Frekvenser er blevet evalueret i henhold til følgende konvention: Meget almindelig (≥ 1/10); almindelig (≥ 1/100 til < 1/10) og ikke almindelig (≥ 1/1000 til < 1/100).
English: (pre- and post-operative)
Danish: (præ- og postoperativt)
English: Frequency of doses (hours)/ Duration of therapy (days)
Danish: Dosisfrekvens (timer)/ Behandlingens varighed (dage)
English: When prescribing ReFacto AF it is important to individually titrate and monitor each patient's factor level in order to ensure an adequate therapeutic response (see section 4.8).
Danish: Ved ordination af ReFacto AF er det vigtigt at foretage en individuel titrering og kontrol af hver patients faktor-niveau for at sikre tilstrækkelig terapeutisk respons (se pkt 4.8).
English: The specific activity of ReFacto AF is 7,600-13,800 IU/mg protein.
Danish: Den specifikke aktivitet for ReFacto AF er 7.600-13.800 IE/mg protein.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Danish: Kravene for fremsendelse af periodiske, opdaterede sikkerhedsindberetninger for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF, og alle efterfølgende opdateringer og offentliggjort på den europæiske webportal for lægemidler.
English: Dose based on bodyweight may require adjustment in underweight or overweight patients.
Danish: Doser baseret på kropsvægt kan kræve justering hos under- eller overvægtige patienter.
English: Uncommon ≥ 1/1,000 to
Danish: Ikke almindelig ≥ 1/1000 til
English: The manufacturing process for ReFacto was modified to eliminate any exogenous human- or animal-derived protein in the cell culture process, purification, or final formulation; and at the same time the invented name was changed to ReFacto AF.
Danish: Fremstillingsprocessen for ReFacto AF blev modificeret for at eliminere alle exogene, humant eller animalsk afledte proteiner i celledyrkningsprocessen, oprensningen og den endelige formulering, og samtidig blev navnet ændret til ReFacto AF.
English: Inform your doctor if you are on a controlled sodium diet.
Danish: Fortæl det til lægen, hvis De er på en kontrolleret natriumdiæt.
English: Date removed from the refrigerator:
Danish: Dato for fjernelse fra køleskab:
English: Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Danish: Læs denne indlægsseddel grundigt, inden De begynder at bruge dette lægemiddel, da den indeholder viggtige oplysninger.
English: Appropriate training is recommended for non-healthcare professionals administering the product.
Danish: Passende uddannelse anbefales til personer, der ikke er sundhedsfagligt uddannede, som skal indgive produktet.
English: Thrombin then converts fibrinogen into fibrin, and a clot is formed.
Danish: Trombin omdanner derefter fibrinogen til fibrin, og der dannes et koagel.
English: ReFacto AF is appropriate for use in adults and children of all ages, including newborns.
Danish: ReFacto AF er velegnet til voksne og børn i alle aldre, samt nyfødte.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Danish: DATO FOR FØRSTE markedsføringsTILLADELSE/FORNYELSE AF TILLADELSEN
English: The ReFacto AF laboratory standard can be used to correct for this discrepancy (see section 5.2).
Danish: ReFacto AFlaboratoriestandarden kan anvendes til at korrigere for denne uoverensstemmelse (se pkt.
English: In order to improve traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Danish: For at forbedre sporbarheden af biologiske lægemidler, bør navnet og batchnummeret på det indgivne præparat registreres tydeligt.
English: This indicates no time-dependent changes in the pharmacokinetic properties of ReFacto AF.
Danish: Dette tyder på, at der ikke er nogen tidsafhængige ændringer i de farmakokinetiske egenskaber for ReFacto AF.
English: In case of severe allergic reactions, alternative therapy must be considered.
Danish: I tilfælde af alvorlige allergiske reaktioner bør en alternativ behandling overvejes.
English: • dizziness and loss of consciousness
Danish: • svimmelhed eller tab af bevidsthed
English: In the presence of an inhibitor, higher doses or appropriate specific treatment may be required.
Danish: Hvis der findes en inhibitor, kan det være nødvendigt med højere doser eller en passende specifik behandling.
English: In general, dose selection for an elderly patient should be individualised.
Danish: Dosisvalg for ældre patienter skal generelt set tilpasses individuelt.
English: Severe symptoms, including difficulty in breathing and (nearly) fainting, require prompt emergency treatment.
Danish: Alvorlige symptomer, såsom besvær med at trække vejret og hvis De (næsten) besvimer, kræver omgående, akut behandling.
English: Minor surgery including tooth extraction
Danish: Mindre kirurgiske indgreb herunder tandudtrækning
English: Your doctor or other healthcare professional should teach you how to infuse ReFacto AF.
Danish: Deres læge eller en anden sundhedsperson skal lære Dem at injicere ReFacto AF.
English: ReFacto AF does not contain von Willebrand factor, and hence is not indicated in von Willebrand's disease.
Danish: ReFacto AF indeholder ikke von Willebrand-faktor og er derfor ikke indiceret ved von Willebrands sygdom.
English: The table presented below is according to the MedDRA system organ classification (SOC and Preferred Term Level).
Danish: Nedenstående tabel er i overensstemmelse med MedDRA's systemorganklassifikation (SOC- og foretrukken term-niveau).
English: Once you learn how to self-infuse, you can follow the instructions in this Package Leaflet.
Danish: Når De først selv har lært at injicere, kan De følge instruktionerne i denne indlægsseddel.
English: EXP Do not use after expiry date.
Danish: EXP Må ikke anvendes efter udløbsdatoen.