FrancophonIA/ELRC3.0 huggingface dataset:
English: ZYPREXA VELOTAB 15 mg orodispersible tablets
Danish: ZYPREXA VELOTAB 15 mg smeltetablet
English: Eli Lilly Nederland B.V. Tel: + 31(0)30 6025800
Danish: Tel: + 31(0)30 6025800
English: Each orodispersible tablet contains 10 mg olanzapine.
Danish: Hver smeltetablet indeholder 10 mg olanzapin.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each orodispersible tablet contains 20 mg olanzapine
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver smeltetablet indeholder 20 mg olanzapin
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON OF ZYPREXA VELOTAB 20 mg ORODISPERSIBLE TABLETS
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE KARTON MED ZYPREXA VELOTAB 20 mg SMELTETABLETTER
English: NAME OF THE MEDICINAL PRODUCT ZYPREXA VELOTAB 15 mg orodispersible tablets Olanzapine
Danish: LÆGEMIDLETS NAVN ZYPREXA VELOTAB 15 mg smeltetabletter Olanzapin
English: 0.1125 mg sodium methyl parahydroxybenzoate, 0.0375 mg sodium propyl parahydroxybenzoate.
Danish: 0,1125 mg natriummethylparahydroxybenzoat 0,0375 mg natriumpropylparahydroxybenzoat ZYPREXA VELOTAB 10 mg smeltetablet
English: How to take ZYPREXA VELOTAB
Danish: Sådan skal du tage ZYPREXA VELOTAB
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS ZYPREXA VELOTAB 20 mg ORODISPERSIBLE TABLETS: BLISTER FOIL LABEL
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP ZYPREXA VELOTAB 20 mg SMELTETABLETTER: BLISTERFOLIE
English: ZYPREXA VELOTAB 5 mg orodispersible tablets
Danish: ZYPREXA VELOTAB 5 mg smeltetablet
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each orodispersible tablet contains 5 mg olanzapine
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver smeltetablet indeholder 5 mg olanzapin
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each orodispersible tablet contains 15 mg olanzapine
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver smeltetablet indeholder 15 mg olanzapin
English: 0.225 mg sodium methyl parahydroxybenzoate, 0.075 mg sodium propyl parahydroxybenzoate.
Danish: 0,225 mg natriummethylparahydroxybenzoat 0,075 mg natriumpropylparahydroxybenzoat ZYPREXA VELOTAB 20 mg smeltetablet
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each orodispersible tablet contains 10 mg olanzapine
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver smeltetablet indeholder 10 mg olanzapin
English: ZYPREXA VELOTAB 10 mg orodispersible tablets
Danish: ZYPREXA VELOTAB 10 mg smeltetablet
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON OF ZYPREXA VELOTAB 5 mg ORODISPERSIBLE TABLETS
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE KARTON MED ZYPREXA VELOTAB 5 mg SMELTETABLETTER
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS ZYPREXA VELOTAB 5 mg ORODISPERSIBLE TABLETS: BLISTER FOIL LABEL
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP ZYPREXA VELOTAB 5 mg SMELTETABLETTER: BLISTERFOLIE
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS ZYPREXA VELOTAB 15 mg ORODISPERSIBLE TABLETS: BLISTER FOIL LABEL
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP ZYPREXA VELOTAB 15 mg SMELTETABLETTER: BLISTERFOLIE
English: ZYPREXA VELOTAB is available in packs containing 28, 35, 56, 70 or 98 tablets.
Danish: Smeltetablet er det tekniske udtryk for en tablet, som straks bliver opløst i din mund, så du let kan sluge den. ZYPREXA VELOTAB 5 mg, 10 mg, 15 mg og 20 mg fås i pakninger med 28, 35, 56, 70 eller 98 tabletter.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON OF ZYPREXA VELOTAB 10 mg ORODISPERSIBLE TABLETS
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE KARTON MED ZYPREXA VELOTAB 10 mg SMELTETABLETTER
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON OF ZYPREXA VELOTAB 15 mg ORODISPERSIBLE TABLETS
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE KARTON MED ZYPREXA VELOTAB 15 mg SMELTETABLETTER
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS ZYPREXA VELOTAB 10 mg ORODISPERSIBLE TABLETS: BLISTER FOIL LABEL
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP ZYPREXA VELOTAB 10 mg SMELTETABLETTER: BLISTERFOLIE
English: EU/1/99/125/002 28 orodispersible tablets EU/1/99/125/010 35 orodispersible tablets EU/1/99/125/006 56 orodispersible tablets EU/1/99/125/014 70 orodispersible tablets EU/1/99/125/018 98 orodispersible tablets
Danish: EU/1/99/125/002 28 smeltetabletter EU/1/99/125/010 35 smeltetabletter EU/1/99/125/006 56 smeltetabletter EU/1/99/125/014 70 smeltetabletter EU/1/99/125/018 98 smeltetabletter
English: EU/1/99/125/001 28 orodispersible tablets EU/1/99/125/009 35 orodispersible tablets EU/1/99/125/005 56 orodispersible tablets EU/1/99/125/013 70 orodispersible tablets EU/1/99/125/017 98 orodispersible tablets
Danish: EU/1/99/125/001 28 smeltetabletter EU/1/99/125/009 35 smeltetabletter EU/1/99/125/005 56 smeltetabletter EU/1/99/125/013 70 smeltetabletter EU/1/99/125/017 98 smeltetabletter
English: EU/1/99/125/004 28 orodispersible tablets EU/1/99/125/012 35 orodispersible tablets EU/1/99/125/008 56 orodispersible tablets EU/1/99/125/016 70 orodispersible tablets EU/1/99/125/020 98 orodispersible tablets
Danish: EU/1/99/125/004 28 smeltetabletter EU/1/99/125/012 35 smeltetabletter EU/1/99/125/008 56 smeltetabletter EU/1/99/125/016 70 smeltetabletter EU/1/99/125/020 98 smeltetabletter
English: EU/1/99/125/003 28 orodispersible tablets EU/1/99/125/011 35 orodispersible tablets EU/1/99/125/007 56 orodispersible tablets EU/1/99/125/015 70 orodispersible tablets EU/1/99/125/019 98 orodispersible tablets
Danish: EU/1/99/125/003 28 smeltetabletter EU/1/99/125/011 35 smeltetabletter EU/1/99/125/007 56 smeltetabletter EU/1/99/125/015 70 smeltetabletter EU/1/99/125/019 98 smeltetabletter
English: What you need to know before you take ZYPREXA VELOTAB 3.
Danish: Det skal du vide, før du begynder at tage ZYPREXA VELOTAB Sådan skal du tage ZYPREXA VELOTAB Bivirkninger
English: • The other ingredients are - gelatin, mannitol (E421), aspartame (E951), sodium methyl parahydroxybenzoate (E219) and sodium propyl parahydroxybenzoate (E217).
Danish: - Øvrige indholdstoffer: Gelatine, mannitol (E421), aspartam (E951),
English: INFORMATION IN BRAILLE ZYPREXA VELOTAB 10 mg
Danish: ZYPREXA VELOTAB 10 mg
English: INFORMATION IN BRAILLE ZYPREXA VELOTAB 5 mg
Danish: ZYPREXA VELOTAB 5 mg
English: NAME OF THE MEDICINAL PRODUCT ZYPREXA VELOTAB 10 mg orodispersible tablets Olanzapine
Danish: ZYPREXA VELOTAB 10 mg smeltetabletter Olanzapin
English: Glutamyltransferase
Danish: Høje niveauer af gammaglutamyltransferase10
English: • The active substance is olanzapine.
Danish: ZYPREXA VELOTAB indeholder: - Aktivt stof: Olanzapin.
English: Amenorrhea Breast enlargement Galactorrhea in females
Danish: Brystforstørrelse Galaktorré hos kvinder Gynækomasti/brystforstørrelse hos mænd
English: This summary was last updated in June 2015.
Danish: Dette sammendrag blev senest ajourført i juni 2015.
English: UpCard is available as tablets (0.75 mg, 3 mg, 7.5 mg and 18 mg) and can only be obtained with a prescription.
Danish: UpCard fås som tabletter (0,75 mg, 3 mg, 7,5 mg og 18 mg) og udleveres kun på recept.
English: The full EPAR for UpCard can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for UpCard findes på agenturets websted under: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: This is a summary of the European public assessment report (EPAR) for UpCard.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for UpCard.
English: It works by increasing the elimination of salt and water in the urine.
Danish: Det virker ved at øge udskillelsen af salt og vand i urinen.
English: Tablets should be kept in the blister packs until required, and the blisters should be kept in the outer carton.
Danish: Tabletterne skal opbevares i blisterpakningen, indtil de bruges, og blisterpakningen skal opbevares i den ydre karton.
English: The European Commission granted a marketing authorisation valid throughout the EU for UpCard on
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele EU for UpCard den
English: UpCard contains the active substance torasemide.
Danish: UpCard indeholder det aktive stof torasemid.
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that UpCard's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Agenturets Udvalg for Veterinærlægemidler (CVMP) konkluderede, at fordelene ved UpCard opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: UpCard is given once daily, with or without food, with the dose adjusted to produce the required effect.
Danish: UpCard gives én gang dagligt med eller uden foder, og i en dosis, der tilpasses, så den ønskede virkning opnås.
English: Other information about UpCard
Danish: Andre oplysninger om UpCard
English: The most common side effects with UpCard are kidney problems and increased thirst, water consumption and urine output, which may affect more than 1 in 10 dogs.
Danish: De hyppigste bivirkninger med UpCard er nyreproblemer og øget tørst, vandindtagelse og urinmængde, som forekommer hos mere end 1 ud af 10 hunde.
English: This decreases the overall blood volume, reducing the effort needed for the heart to pump blood and thereby improving its function.
Danish: Dette nedsætter det samlede blodvolumen og dermed hjertets pumpearbejde, så hjertefunktionen bliver bedre.
English: People with known hypersensitivity (allergy) to torasemide or other sulphonamides should give the medicine with caution.
Danish: Personer med kendt allergi over for torasemid eller andre sulfonamider bør være forsigtige, når de giver lægemidlet.
English: Once signs of congestive heart failure have been controlled, if long-term treatment is required the lowest effective dose should be given.
Danish: Når symptomerne på hjertesvigt med væskeophobning er under kontrol, vælges den laveste effektive dosis, hvis det er nødvendigt med langvarig behandling.
English: In case of accidental ingestion, particularly by children, medical advice should be sought immediately and the package leaflet or label shown to the doctor.
Danish: I tilfælde af utilsigtet indtagelse, særlig hos et barn, skal der straks søges lægehjælp, og indlægssedlen eller etiketten skal vises til lægen.
English: It is not intended to provide practical advice on how to use UpCard.
Danish: Det er ikke en praktisk vejledning i, hvordan UpCard bør anvendes.
English: This product may increase urination and gastrointestinal disturbances if ingested.
Danish: Dette produkt kan give øget vandladning og mave-tarmbesvær, hvis det indtages.
English: What is UpCard and what is it used for?
Danish: Hvad er UpCard, og hvad anvendes det til?
English: Why is UpCard approved?
Danish: Hvorfor blev UpCard godkendt?
English: The main measure of effectiveness was response to treatment after about 3 months of treatment, scoring the difficulty breathing, cough frequency, exercise intolerance and fluid retention in the abdomen.
Danish: Det vigtigste mål for virkningen var reaktionen på lægemidlet efter tre måneders behandling, hvor der blev givet scoreværdier for vejrtrækningsbesvær, hyppighed af hoste, intolerance over for motion og væskeophobning i bughulen.
English: The study showed UpCard to be at least as effective as furosemide for treatment of signs related to congestive heart failure.
Danish: Undersøgelsen viste, at UpCard var mindst ligeså effektivt som furosemid til behandling af symptomer ved hjertesvigt med væskeophobning.
English: In a field study involving 251 dogs with congestive heart failure, treatment with UpCard was compared to a standard treatment with the diuretic furosemide.
Danish: Der er udført en feltundersøgelse med 251 hunde med hjertesvigt med væskeophobning, hvor UpCard blev sammenlignet med standardbehandling med det vanddrivende middel furosemid.
English: For the full list of restrictions and side effects reported with UpCard, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger med UpCard fremgår af indlægssedlen.
English: UpCard is a veterinary medicine used to treat signs of congestive heart failure in dogs.
Danish: UpCard er et veterinærlægemiddel, der anvendes til behandling af symptomer på hjertesvigt med væskeophobning hos hunde.
English: What are the risks associated with UpCard?
Danish: Hvilke risici er der forbundet med UpCard?
English: Safety information has been included in the summary of product characteristics and the package leaflet for UpCard, including the precautions to be followed by healthcare professionals and animal owners or keepers.
Danish: Der er anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for UpCard, herunder passende forholdsregler, som skal følges af sundhedspersoner og den, der er ejer af eller ansvarlig for dyret.
English: UpCard
Danish: UpCard torasemid
English: What benefits of UpCard have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved UpCard?
English: How does UpCard work?
Danish: Hvordan virker UpCard?
English: For more information about treatment with UpCard, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Danish: Hvis du som ejer eller ansvarlig for dyret ønsker yderligere oplysninger om behandling med UpCard, kan du læse indlægssedlen eller kontakte din dyrlæge eller dit apotek.
English: How is UpCard used?
Danish: Hvordan anvendes UpCard?
English: For practical information about using UpCard, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Danish: Hvis du som ejer eller ansvarlig for dyret ønsker praktisk vejledning om anvendelsen af UpCard, kan du læse indlægssedlen eller kontakte din dyrlæge eller dit apotek.
English: Congestive heart failure is a condition, usually of older dogs, where the heart fails to pump blood efficiently around the body leading to clinical signs such as exercise intolerance (inability to carry out physical activity), difficulty breathing and fluid retention.
Danish: Dette medfører kliniske symptomer i form af manglende evne til fysisk aktivitet (intolerance over for motion), vejrtrækningsbesvær og væskeophobning.
English: As a result, the cancer cells cannot divide, slowing down the growth of tumours.
Danish: Som resultat heraf kan kræftcellerne ikke dele sig, hvilket hæmmer svulsternes vækst.
English: The full EPAR for Temozolomide Sun can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Temozolomide Sun findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Temozolomide Sun should be taken without food.
Danish: Temozolomide Sun skal tages uden mad.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Temozolomide Sun on 13 July 2011.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Temozolomide Sun den 13. juli 2011.
English: The dose of Temozolomide Sun depends on body surface area (calculated using the patient's height and weight) and ranges from 75 to 200 mg per square metre, once a day.
Danish: Dosis af Temozolomide Sun afhænger af kropsoverfladen (beregnet ud fra patientens højde og vægt) og ligger på mellem 75 mg og 200 mg pr. kvadratmeter en gang dagligt.
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 Temozolomide Sun.
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 Temozolomide Sun.
English: The dose and the number of doses depend on the type of tumour being treated, whether the patient has been treated before, whether Temozolomide Sun is being used alone or with other treatments, and how the patient responds to treatment.
Danish: Dosis og antallet af doser afhænger af, hvilken kræfttype der skal behandles, om patienten er blevet behandlet før, om Temozolomide Sun anvendes alene eller sammen med andre behandlinger, og hvordan patienten responderer på behandlingen.
English: This is a summary of the European public assessment report (EPAR) for Temozolomide Sun.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Temozolomide Sun.
English: It is used to treat malignant glioma (brain tumours) in the following groups of patients:
Danish: Det anvendes til behandling af ondartet gliom (svulster i hjernen) hos følgende patientgrupper:
English: This means that Temozolomide Sun is similar to a ‘reference medicine' already authorised in the European Union (EU) called Temodal.
Danish: Det betyder, at Temozolomide Sun er identisk med et ‘referencelægemiddel', som allerede er godkendt i Den Europæiske Union (EU), og som hedder Temodal.
English: For more information about treatment with Temozolomide Sun, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Temozolomide Sun, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Patients may also need to take medicines to prevent vomiting before taking Temozolomide Sun. Temozolomide Sun should be used with caution in patients with severe liver problems or with kidney problems.
Danish: Patienter kan også få brug for at tage medicin mod opkastning, inden de tager Temozolomide Sun. Temozolomide Sun skal anvendes med forsigtighed hos patienter med svære leverproblemer eller med nyreproblemer.
English: Temozolomide Sun is used on its own in these patients.
Danish: Temozolomide Sun anvendes alene hos disse patienter.
English: The CHMP concluded that, in accordance with EU requirements, Temozolomide Sun has been shown to have comparable quality and to be bioequivalent to Temodal.
Danish: CHMP konkluderede, at det i overensstemmelse med EU's krav er blevet påvist, at Temozolomide Sun er af sammenlignelig kvalitet og er bioækvivalent med Temodal.
English: Temozolomide Sun is used first with radiotherapy and then on its own;
Danish: Temozolomide Sun bruges først sammen med strålebehandling og herefter alene.
English: Treatment with Temozolomide Sun should be prescribed by a doctor with experience in the treatment of brain tumours.
Danish: Behandling med Temozolomide Sun skal ordineres af en læge, som har erfaring med behandling af hjernesvulster.
English: EPAR summary for the public temozolomide
Danish: EPAR - sammendrag for offentligheden temozolomid
English: Because Temozolomide Sun is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Temodal.
Danish: Da Temozolomide Sun er et generisk lægemiddel, har undersøgelserne hos patienter været begrænset til test for at fastslå, at det er bioækvivalent med referencelægemidlet Temodal.
English: The Committee recommended that Temozolomide Sun be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Temozolomide Sun.
English: The active substance in Temozolomide Sun, temozolomide, belongs to a group of anticancer medicines called alkylating agents.
Danish: Det aktive stof i Temozolomide Sun, temozolomid, tilhører en gruppe af lægemidler mod kræft kaldet alkylerende midler.
English: Because Temozolomide Sun is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Danish: Da Temozolomide Sun er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: Other information about Temozolomide Sun
Danish: Andre oplysninger om Temozolomide Sun:
English: Temozolomide Sun is a medicine that contains the active substance temozolomide.
Danish: Temozolomide Sun er et lægemiddel, der indeholder det aktive stof temozolomid.
English: What are the benefits and risks of Temozolomide Sun?
Danish: Hvilken fordel og risiko er der forbundet med Temozolomide Sun?
English: Temozolomide Sun is an anticancer medicine.
Danish: Temozolomide Sun er et lægemiddel mod kræft.
English: Temozolomide Sun is a ‘generic medicine'.
Danish: Temozolomide Sun er et ‘generisk lægemiddel'.
English: Why has Temozolomide Sun been approved?
Danish: Hvorfor blev Temozolomide Sun godkendt?
English: What is Temozolomide Sun?
Danish: Hvad er Temozolomide Sun?
English: How has Temozolomide Sun been studied?
Danish: Hvordan blev Temozolomide Sun undersøgt?
English: What is Temozolomide Sun used for?
Danish: Hvad anvendes Temozolomide Sun til?
English: How is Temozolomide Sun used?
Danish: Hvordan anvendes Temozolomide Sun?
English: How does Temozolomide Sun work?
Danish: Hvordan virker Temozolomide Sun?
English: Disposal of unwanted medicine
Danish: Bortskaffelse af uønsket medicin
English: Date of counselling
Danish: Dato for rådgivning
English: The Member States should agree the local implementation of the patient card system
Danish: Medlemsstaterne skal blive enige om den lokale implementering af patientkortsystemet.
English: The Member States shall ensure that the following key elements are included in the appropriate material:
Danish: Medlemsstaterne skal sikre, at følgende nøgleelementer er indeholdt i det relevante materiale:
English: • Post-marketing and compliance assessment (as applicable to a Member State)
Danish: • Post-markedsføring og kompliansvurdering (som relevant for den pågældende medlemsstat)
English: It is not a contract and does not absolve anybody from his/her responsibilities with regard to the safe use of the product and prevention of foetal exposure.”
Danish: Det er ikke en kontrakt og frikender ikke nogen for deres ansvar mht. sikker anvendelse af produktet og forebyggelse af føtal eksponering."
English: • The need for effective contraception
Danish: • Nødvendigheden af effektiv prævention
English: The Dear Healthcare Professional letter will consist of two parts:
Danish: Kære Sundhedspersonale-brev Kære Sundhedspersonale-brevet vil bestå af to dele:
English: • Core text as agreed by the CHMP
Danish: • En kernetekst som skal godkendes af CHMP
English: Results of the user testing will have to be provided to the national competent authority and final materials validated at a national level.
Danish: Resultaterne af brugerafprøvningen skal udleveres til den nationale, kompetente myndighed og det endelige materiale godkendes på nationalt niveau.
English: Patients involved should be preferably naïve to the history of thalidomide.
Danish: Involverede patienter bør helst være ubekendte med thalidomids historie.
English: • That if she is pregnant or plans to be, she must not take Thalidomide Celgene
Danish: • At hun, hvis hun er gravid eller forventer at blive gravid, ikke må tage Thalidomide Celgene
English: The Member States must ensure that all conditions or restrictions with regard to the safe and effective use of the medicinal product described below are implemented:
Danish: Medlemsstaterne skal sikre, at alle betingelser eller begrænsninger med hensyn til sikker og effektiv anvendelse af det nedenfor nævnte lægemiddel implementeres:
English: o Safety Advice relevant to all patients Description and management of thromboembolic and cardiovascular events, and peripheral neuropathy
Danish: o Sikkerhedsrådgivning, der er relevant for alle patienter Beskrivelse og håndtering af tromboemboliske og kardiovaskulære hændelser og perifer neuropati
English: • That he should return the capsules to the pharmacist at the end of treatment
Danish: • At han skal levere kapslerne tilbage til apoteket ved behandlingens afslutning