FrancophonIA/ELRC3.0 huggingface dataset:
English: Microcrystalline cellulose, pregelatinised starch, silicon dioxide, sodium lauryl sulphate, magnesium stearate, lactose monohydrate, indigo carmine (E132), titanium dioxide (E171).
Danish: Kapselindhold Mikrokrystallinsk cellulose, prægelatineret stivelse, silica, natriumlaurilsulfat, magnesiumstearat, lactose monohydrat, indigo carmin (E132), titandioxid (E171).
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Danish: De eller Deres pårørende kan også indberette bivirkninger direkte til Sundhedsstyrelsen via www.meldenbivirkning.dk, på mail til sst@sst.dk eller via brev til Sundhedsstyrelsen, Axel Heides Gade 1, 2300 København S. Ved at indrapportere bivirkninger kan De hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.
English: Sonata has been shown to preserve sleep stages in controlled studies that measured the percentage of sleep time spent in each sleep stage.
Danish: I kontrollerede studier, hvor man målte procenten af søvn i hvert søvnstadie, er Sonata påvist at opretholde søvnstadierne.
English: The other ingredients are microcrystalline cellulose, pregelatinised starch, silicon dioxide, sodium lauryl sulphate, magnesium stearate, lactose monohydrate, indigo carmine (E132), titanium dioxide (E171).
Danish: De øvrige indholdsstoffer er Mikrokrystallinsk cellulose, prægelatineret stivelse, silica, natriumlaurilsulfat, magnesiumstearat, lactosemonohydrat, indigocarmin (E132), titandioxid (E171).
English: visual impairment, diplopia
Danish: Unormalt syn, dobbeltsyn
English: Printing inks on the shell contain the following (pink ink SW-1105): shellac, titanium dioxide (E171), ammonium hydroxide, red iron oxide (E172), yellow iron oxide (E172).
Danish: Trykfarverne på kapslen indeholder følgende (lyserød farve SW-1105): shellac, titandioxid (E171), ammoniumhydroxid, rød jernoxid (E172), gul jernoxid (E172).
English: What Sonata is and what it is used for What you need to know before you take Sonata How to take Sonata
Danish: Det skal De vide, før De begynder at tage Sonata Sådan skal De tage Sonata Bivirkninger
English: In severe cases, use of activated charcoal or gastric lavage may be useful when performed soon after ingestion.
Danish: I alvorlige tilfælde kan indgift af aktivt kul eller mavetømning være en fordel, hvis det sker kort tid efter indtagelse af Sonata.Yderligere, kan det være nødvendigt at stabiliserer cirkulationen og en intensiv overvågning kan være nødvendig.
English: Excipient with known effect: Lactose monohydrate 49 mg. For the full list of excipients, see section 6.1.
Danish: Hjælpestof, som behandleren skal være opmærksom på: Lactosemonohydrat 49 mg Alle hjælpestoffer er anført under pkt.
English: Excipient with known effect: Lactose monohydrate 54 mg. For the full list of excipients, see section 6.1.
Danish: Hjælpestof som behandleren skal være opmærksom på: Lactosemonohydrat 54 mg. Alle hjælpestoffer er anført under pkt.
English: In contrast, rifampicin, a strong inducer of several hepatic enzymes, including CYP3A4 resulted in a four fold reduction in zaleplon plasma concentration.
Danish: CYP3A4, bevirkede derimod en fire ganges reduktion i plasmakoncentrationen af zaleplon.
English: Excretion
Danish: Elimination
English: Tel: +420 234 064 203
Danish: CZ 100 10 Praha 10 Tel: +420 234 064 203
English: • Reactions like restlessness, agitation, irritability, aggressiveness, abnormal thinking, delusion, rages, nightmares, depersonalisation, hallucinations, psychoses, inappropriate behaviour, extroversion that seems out of character and other behavioural effects have been reported following use of any medicines belonging to the sleep inducing group, including Sonata.
Danish: • Reaktioner som rastløshed, ophidselse, irritabilitet, aggressivitet, unormal tænkning, vrangforestillinger, raserianfald, mareridt, uvirkeligheds- eller fremmedfølelse, hallucinationer, tvangstanker (psykoser), upassende adfærd, udadvendthed som ikke synes at passe til personen og andre uønskede adfærdsmæssige reaktioner kan forekomme ved brug af søvnfremkaldende medicin inklusiv Sonata.
English: Capsule shell gelatin, titanium dioxide (E171), sodium lauryl sulphate,
Danish: Kapselskal: gelatine, titandioxid (E171), natriumlaurylsulfat,
English: The no-effect dose for growth of rat offspring was 10 mg/kg (equivalent to 5-times the MRHD on a mg/m2 basis).
Danish: Hos rotter gav doser på 10 mg/kg (svarende til 5 gange den maksimale anbefalede humane dosis baseret på mg/m2) ingen effekt på væksten af afkommet.
English: The no-effect dose for postnatal development was 1 mg/kg/day (equivalent to 0.5-times the MRHD on a mg/m2 basis).
Danish: En dosis på 1 mg/kg/dag (svarende til 0,5 gange den maksimale anbefalede humane dosis baseret på mg/m2) gav ingen effekt på den postnatale udvikling.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 10 MG CAPSULE BLISTERS
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ BLISTERKORT OG BLISTERSTRIPS SONATA 10 MG KAPSLER
English: Capsule shell gelatin, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172), black iron oxide (E172), sodium lauryl sulphate,
Danish: Kapselskal: gelatine, titandioxid (E171), rød jernoxid (E172), gul jernoxid (E172), sort jernoxid (E172), natriumlaurylsulfat
English: MARKETING AUTHORISATION NUMBER(S) EU/1/99/102/004 7 capsules
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/99/102/004 - 7 kapsler
English: MARKETING AUTHORISATION NUMBER(S) EU/1/99/102/001 7 capsules
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/99/102/001 - 7 kapsler
English: EU/1/99/102/002 10 capsules EU/1/99/102/003 14 capsules
Danish: EU/1/99/102/003 - 14 kapsler
English: Ingredients of the capsule shell: gelatin, titanium dioxide (E171) and sodium lauryl sulphate.
Danish: Kapslens skal indeholder: gelatine, titandioxid (E171) og natriumlaurylsulfat .
English: Ingredients of the capsule shell: gelatin, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172), black iron oxide (E172) and sodium lauryl sulphate.
Danish: Kapslens skal indeholder: gelatine, titandioxid (E171), rød jernoxid (E172), gul jernoxid (E172), sort jernoxid (E172) og natriumlaurylsulfat.
English: Severe renal impairment
Danish: Alvorligt nedsat nyrefunktion
English: NAME OF THE MEDICINAL PRODUCT Sonata 5 mg hard capsules
Danish: LÆGEMIDLETS NAVN Sonata 5 mg, hårde kapsler.
English: Therefore, in view of available data regarding next day effects on driving and mental alertness, the PRAC considered that changes to the product information were warranted.
Danish: PRAC fandt derfor ændringerne til produktinformationen berettigede på baggrund af de tilgængelige informationer vedrørende næste dags virkninger på evnen til at køre bil og på den mentale årvågenhed.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains 5 mg zaleplon
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver kapsel indeholder 5 mg zaleplon
English: EU/1/99/102/005 10 capsules EU/1/99/102/006 14 capsules
Danish: EU/1/99/102/006 - 14 kapsler
English: NAME OF THE MEDICINAL PRODUCT Sonata 5 mg hard capsules zaleplon
Danish: LÆGEMIDLETS NAVN Sonata 5 mg, hårde kapsler zaleplon
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains 10 mg zaleplon
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver kapsel indeholder 10 mg zaleplon
English: NAME OF THE MEDICINAL PRODUCT Sonata 10 mg hard capsules
Danish: LÆGEMIDLETS NAVN Sonata 10 mg, hårde kapsler.
English: Elderly patients may be sensitive to the effects of hypnotics; therefore, 5 mg is the recommended dose of Sonata.
Danish: Derfor er 5 mg Sonata den anbefalede dosis.
English: Reactions like restlessness, agitation, irritability, decreased inhibition, aggressiveness, abnormal thinking, delusions, rages, nightmares, depersonalisation, hallucinations, psychoses, inappropriate behaviour, extroversion that seems out of character and other adverse behavioural reactions are known to occur when using benzodiazepines or benzodiazepine-like agents.
Danish: Det vides, at reaktioner som f.eks. hvileløshed, ophidselse, irritabilitet, nedsat hæmning, aggressivitet, unormal tænkning, vrangforestillinger, raserianfald, mareridt, depersonalisation, hallucinationer, psykoser, upassende adfærd, udadvendthed som ikke synes at passe til personen og andre uønskede adfærdsmæssige reaktioner kan forekomme ved brug af benzodiazepiner eller benzodiazepin-lignende midler.
English: NAME OF THE MEDICINAL PRODUCT Sonata 10 mg hard capsules zaleplon
Danish: LÆGEMIDLETS NAVN Sonata 10 mg, hårde kapsler Zaleplon
English: Reactions like restlessness, agitation, irritability, decreased inhibition, aggressiveness, abnormal thinking, delusion, rages, nightmares, depersonalisation, hallucinations, psychoses, inappropriate behaviour, extroversion that seems out of character and other behavioural effects are known to occur when using benzodiazepines or benzodiazepine-like agents.
Danish: Det vides, at reaktioner som f.eks. hvileløshed, ophidselse, irritabilitet, nedsat hæmning, aggressivitet, unormal tænkning, vrangforestillinger, raserianfald, mareridt, depersonalisation, hallucinationer, psykoser, upassende adfærd, udadvendthed som ikke synes at passe til personen og andre adfærdsmæssige påvirkninger kan forekomme ved brug af benzodiazepiner eller benzodiazepinlignende midler.
English: If you have any further questions, ask your doctor or pharmacist.
Danish: Spørg Deres læge eller apotek, hvis De har yderligere spørgsmål.
English: MEDA Pharma GmbH & Co. KG Benzstraße 1
Danish: KG Benzstraße 1
English: If you notice any of the following, or any other changes in your health, do tell your doctor as soon as possible.
Danish: Tal med lægen hurtigst muligt, hvis De får en af følgende bivirkninger eller andre ændringer i dit helbred.
English: Therapy of overdose
Danish: Behandling af overdosering
English: MEDA Pharma B.V. Krijgsman 20
Danish: MEDA Pharma B.V.
English: If you take more Sonata than you should
Danish: Hvis De har taget for meget Sonata
English: Very common (1/10)
Danish: Hyppigheden er defineret som Meget almindelig (≥1/10) Almindelig (≥1/100 til <1/10)
English: Check with your doctor or pharmacist if you are not sure.
Danish: - Spørg lægen eller apotekspersonalet, hvis der er mere, De vil vide.
English: Gastrointestinal disorders Uncommon:
Danish: Mave-tarm-kanalen' Ikke almindelig
English: Elderly
Danish: Ældre:
English: EXP
Danish: Anv.
English: capsule, hard
Danish: kapsel, hård
English: Annex I List of the invented names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the member states
Danish: Bilag I Liste over særnavne, lægemiddelformer, lægemidlernes styrker, administrationsveje, indehavere af markedsføringstilladelse i medlemsstaterne
English: Pharmaceutical Form Route of administration
Danish: Lægemiddelform Administrationsvej
English: oral solution
Danish: oral opløsning
English: Solution for injection, solution for infusion
Danish: Opløsning, injektion, solution for infusion
English: LOFTON 150 mg/ml gotas orales en solución oral drops solution
Danish: LOFTON 150 mg/ml gotas orales en solución orale drabber, opløsning oral anvendelse
English: INTRAVENOUS INFUSION, INTRAVENOUS INJECTION, INTRAMUSCULAR
Danish: INTRAVENØS INFUSION, INTRAVENØS INJEKTION, INTRAMUSKULÆR
English: Actavis Deutschland GmbH & Co. KG Elisabeth-Selbert-Str. 1
Danish: KG Elisabeth-Selbert-Str. 1
English: Ikelan solution for injection or infusion 50mg/5ml injection
Danish: Ikelan Opløsning, injektion or infusion 50mg/5ml injektion
English: LOFTON 150 mg comprimidos recubiertos coated tablet
Danish: LOFTON 150 mg comprimidos recubiertos overtrukken tablet
English: LOFTYL 50 mg/5 ml, solution injectable
Danish: LOFTYL 50 mg/5 ml, solution injectable 50 mg/5 ml
English: Buflomedil-CT 50mg/5ml Ampullen
Danish: Buflomedil-CT 50mg/5ml Ampullen 50mg / 5ml
English: CONTROLLED RELEASE TABLET
Danish: TABLET MED KONTROLLERET FRIGIVELSE
English: Buvasodil film coated tablets
Danish: Buvasodil filmovertrukne tabletter oral anvendelse
English: oral drop, solution
Danish: ORALE DRÅBER, OPLØSNING
English: AMDIPHARM LIMITED 3, TEMPLE CHAMBERS IRL DUBLIN
Danish: Luxembourg AMDIPHARM LIMITED 3, TEMPLE CHAMBERS IRL DUBLIN
English: Prolonged-release tablet oral use ratiopharm GmbH Graf-Arco-STr. 3 D-89079 Ulm Germany
Danish: Depottabletter ratiopharm GmbH Graf-Arco-STr. 3 D-89079 Ulm Germany
English: ORAL DROPS SOLUTION oral use
Danish: orale dråber, opløsning oral anvendelse
English: Intramuscular and intravenous use
Danish: Intramuskulær og intravenøs anvendelse
English: SUSTAINED RELEASE TABLET
Danish: TABLET MED JÆVN FRIGIVELSE
English: tablets
Danish: Tabletter
English: BufloMed 'S.Med' retard 600 mg Filmtabletten prolonged-release tablet oral use
Danish: BufloMed 'S.Med' retard 600 mg Filmtabletten depottablet
English: Intravenous and intramuscular use
Danish: Intravenøs og intramuskulær anvendelse
English: FONZYLANE 150 mg, comprimé pelliculé 150 mg
Danish: LOFTYL 150 mg, comprimé pelliculé 150 mg
English: coated tablet
Danish: overtrukken tablet
English: prolonged-release tablet oral use
Danish: OVERTRUKKEN TABLET oral anvendelse
English: solution for injection
Danish: Opløsning, injektion
English: solution for injection intramuscular and intravenous use
Danish: Opløsning, injektion Intramuskulær og intravenøs anvendelse
English: Packaging
Danish: Emballage
English: Pharmaceutical Form Route of Administration
Danish: Lægemiddelform Indgivelsesvej
English: Content Package size
Danish: Paknings-størrelse
English: Invented name
Danish: Særnavn Styrke
English: Strength Pharmaceutical form
Danish: Styrke Lægemiddelform
English: MA (EU) number (Invented) name
Danish: MF (EU)-nummer
English: Immediate packaging
Danish: Administration Emballage
English: Pack size
Danish: Pakningsstørrelser
English: MA (EU) number (Invented) name Strength
Danish: MF (EU)-nummer.
English: Other changes
Danish: Andre ændringer
English: The main areas harmonised include:
Danish: De vigtigste harmoniserede områder er følgende:
English: What is Femara?
Danish: Hvad er Femara?
English: Outcome of a procedure under Article 30 of Directive 2001/83/EC
Danish: Resultatet af en procedure i henhold til artikel 30 i direktiv 2001/83/EF
English: 22 May 2012
Danish: Den 22. maj 2012
English: Why was Femara reviewed?
Danish: Hvorfor blev Femara revurderet?
English: Femara is authorised in the EU via national procedures.
Danish: Femara blev godkendt i EU via nationale procedurer.
English: The European Commission issued a decision on 22 May 2012.
Danish: Europa-Kommissionen traf en afgørelse den 22. maj 2012.
English: The company that markets these medicines is Novartis.
Danish: Den virksomhed, der markedsfører disse lægemidler, er Novartis.
English: On 15 March 2012, the European Medicines Agency completed a review of Femara.
Danish: Den 15. marts 2012 afsluttede Det Europæiske Lægemiddelagentur en gennemgang af Femara.
English: The amended information to doctors and patients is available here.
Danish: De ændrede produktoplysninger for læger og patienter findes her.
English: The CHMP was of the view that it was more appropriate to include relevant warnings in section 4.4.
Danish: CHMP fandt det mere hensigtsmæssigt at indsætte advarsler herom i afsnit 4.4.
English: 4.3 Contra-indications
Danish: 4.3 Kontraindikationer
English: Femara is a medicine that contains the active substance letrozole.
Danish: Femara er et lægemiddel, der indeholder det aktive stof letrozol.
English: The CHMP also harmonised other sections of the SmPC including sections 4.6 (pregnancy and lactation) and 4.8 (side effects).
Danish: CHMP harmoniserede desuden andre afsnit af produktresuméet, herunder afsnit 4.6 (graviditet og amning) og 4.8 (bivirkninger).
English: On 31 August, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Femara in the EU.
Danish: Den 31. august indbragte Europa-Kommissionen sagen for CHMP med henblik på at harmonisere markedsføringstilladelserne for Femara i EU.
English: Questions and answers on Femara and associated names (letrozole, 2.5 mg tablets) EMA/180824/2012
Danish: Spørgsmål og svar om Femara og relaterede navne (letrozol, tabletter, 2,5 mg) EMA/180824/2012
English: Femara is marketed in all EU Member States and is also available under other trade names: Femar, Fémara, and Loxifan.
Danish: Femara er desuden tilgængeligt i EU under andre handelsnavne: Femar, Fémara og Loxifan.
English: Questions and answers on Femara and associated names (letrozole, 2.5 mg tablets)
Danish: Spørgsmål og svar om Femara og relaterede navne (letrozol, tabletter, 2,5 mg)
English: The active substance in Femara, letrozole, is an ‘aromatase inhibitor'.
Danish: Det aktive stof i Femara, letrozol, er en aromatasehæmmer.
English: This has led to divergences across Member States in the way the medicine can be used, as seen in the differences in the summaries of product characteristics (SmPCs), labelling and package leaflets in the countries where the medicine is marketed.
Danish: Dette har ført til afvigelser mellem medlemsstaterne i den måde, lægemidlet kan anvendes på, således som det fremgår af forskellene mellem produktresuméer, etikettering og indlægssedler i de lande, hvor lægemidlet markedsføres.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that there is a need to harmonise the prescribing information for Femara in the European Union (EU).
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at der er behov for en harmonisering af produktoplysningerne for Femara i Den Europæiske Union (EU).
English: This means that it works by blocking the action of an enzyme called ‘aromatase', which is involved in the production of the hormone oestrogen.
Danish: Det vil sige, at det virker ved at blokere virkningen af enzymet aromatase, der medvirker ved produktionen af hormonet østrogen.
English: After reviewing the available data supporting the medicine's use, the CHMP agreed that Femara should be used in postmenopausal women for the following:
Danish: Efter gennemgang af oplysningerne til støtte for lægemidlets anvendelse fandt CHMP, at Femara bør anvendes hos kvinder efter overgangsalderen til følgende:
English: The CHMP, in light of the data submitted and the scientific discussion within the Committee, was of the opinion that the SmPCs, labelling and package leaflets should be harmonised across the EU.
Danish: På grundlag af de forelagte oplysninger og den videnskabelige drøftelse i udvalget var CHMP af den opfattelse, at produktresuméer, etikettering og indlægssedler bør harmoniseres i EU.
English: In harmonising the contraindications, the CHMP decided against including two contraindications that were in the SmPCs of some EU countries: liver impairment and pre-operative use in patients whose receptor status is negative or unknown.
Danish: Ved harmoniseringen af kontraindikationerne besluttede CHMP at undlade to kontraindikationer, der var anført i produktresuméerne i visse EU-lande: nedsat leverfunktion og anvendelse før operation hos patienter med negativ eller ukendt receptorstatus.
English: Having harmonised the indications, the CHMP also harmonised recommendations on the doses, duration of treatment and use of Femara in patients with reduced kidney or liver function.
Danish: Foruden indikationerne harmoniserede CHMP også dosisanbefalingerne, behandlingsvarigheden og anvendelsen af Femara hos patienter med nedsat nyre- eller leverfunktion.
English: • Advanced breast cancer after relapse or disease progression, in women with natural or artificially induced postmenopausal endocrine status, who have previously been treated with anti-oestrogens.
Danish: • Fremskreden brystkræft efter tilbagefald eller fremadskriden af sygdommen hos kvinder, der har naturlig eller kunstigt fremkaldt hormonstatus svarende til efter overgangsalderen og tidligere er blevet behandlet med antiøstrogener.
English: Femara is used in postmenopausal women because aromatase is involved in producing most of the oestrogen in this population.
Danish: Femara anvendes til kvinder efter overgangsalderen, da størstedelen af deres østrogenproduktion sker ved hjælp af aromatase.
English: • First-line treatment for hormone-dependent advanced breast cancer.
Danish: • Førstevalgsbehandling af hormonafhængig fremskreden brystkræft.
English: It is used as hormonal treatment in postmenopausal women with breast cancer.
Danish: Det anvendes som hormonbehandling af brystkræft hos kvinder efter overgangsalderen.
English: • Neo-adjuvant (pre-surgery) treatment of hormone receptor positive, HER-2 negative breast cancer where chemotherapy is not suitable and immediate surgery not indicated.
Danish: • Behandling før operation af hormonreceptorpositiv HER-2-negativ brystkræft, hvor kemoterapi ikke er hensigtsmæssig og øjeblikkelig operation ikke er berettiget.
English: Femara was identified as needing harmonisation by the Co-ordination Group on the Mutual and Decentralised Procedures - Human (CMD(h)).
Danish: Koordinationsgruppen Vedrørende Gensidig Anerkendelse og Decentraliserede Godkendelsesprocedurer - human (CMD(h)) fandt, at der er behov for harmonisering for Femara.
English: • Extended adjuvant treatment of hormone-dependent invasive breast cancer in women who have received prior standard adjuvant tamoxifen therapy for five years.
Danish: • Forlænget støttende behandling af hormonafhængig invasiv brystkræft efter fem års forudgående standardbehandling med tamoxifen.
English: • Adjuvant (post-surgery) treatment of hormone receptor positive invasive early breast cancer.
Danish: • Støttende behandling (efter operation) af hormonreceptorpositiv invasiv brystkræft i tidligt stadium.
English: In some types of breast cancer (hormone receptor positive or hormone-dependent types), oestrogen is known to stimulate the growth of the cancer cells.
Danish: Østrogen vides at fremme kræftcellers vækst ved visse brystkræftformer (hormonreceptorpositive eller hormonafhængige former).
English: By blocking the activity of aromatase and thereby reducing the amount of oestrogen produced, the medicine slows or stops the growth and spread of the cancer.
Danish: Dette bremser eller standser kræftsygdommens vækst og spredning.
English: The process takes about 6 to 8 weeks.
Danish: Denne proces varer 6-8 uger.
English: 72 hours
Danish: 72 timer
English: This may take up to one year.
Danish: Dette kan vare op til et år.
English: Do not irradiate.
Danish: Må ikke bestråles.
English: The physician will be informed immediately.
Danish: Lægen vil straks blive underrettet herom.
English: System Organ Class (SOC)
Danish: Systemorganklasse (SOC)
English: Your doctor might have to select an alternative treatment for you.
Danish: Lægen kan være nødt til at vælge en anden behandling til dig.
English: A debridement of the defect area is required.
Danish: Debridement af det defekte område er nødvendig.
English: The program may take up to one year depending on the recommendation of the physician.
Danish: Programmet kan vare op til et år afhængigt af lægens anbefaling.
English: The intention-to-treat (ITT) population consisted of 73 patients.
Danish: Intention-to-treat (ITT)-populationen bestod af 73 patienter.
English: Remaining spheroids must not be stored for later application.
Danish: Resterende sfæroider må ikke opbevares til senere anvendelse.
English: • Specific testing and examination of the patient to ensure compliance with strictly defined clinical criteria
Danish: • specifik testning og undersøgelse af patienten med henblik på at sikre overholdelse af nøje definerede kliniske kriterier
English: The following requirements need to be fulfilled before the product is prescribed and dispensed:
Danish: Følgende krav skal være opfyldt, inden produktet og ordineres og udleveres:
English: Physical activity should be resumed as recommended by the physician.
Danish: Fysisk aktivitet bør genoptages som anbefalet af lægen.