FrancophonIA/ELRC3.0 huggingface dataset:
English: If symptoms reappear, treatment with Protopy 0.1% twice a day should be restarted.
Danish: Hvis symptomerne vender tilbage, skal man genoptage behandling med Protopy 0,1% to gange om dagen.
English: Depending on the response of your eczema your doctor will decide if the frequency of application can be reduced or the lower strength, Protopy 0.03% ointment, can be used.
Danish: Afhængig af, hvordan Deres eksem reagerer, vil lægen afgøre om hyppigheden af påsmøringer kan reduceres eller den svagere salve, Protopy 0,03% salve, kan benyttes.
English: Tacrolimus ointment does not affect collagen synthesis in humans.
Danish: Tacrolimus salve har ingen effekt på kollagensyntesen hos mennesker.
English: The hepatic clearance of systemically available tacrolimus could be reduced in subjects with severe hepatic impairment, or in subjects who are cotreated with drugs that are potent inhibitors of CYP3A4.
Danish: Den hepatiske clearance af systemisk tilgængeligt tacrolimus kan vær nedsat hos patienter med svær nedsættelse af leverfunktionen, eller ved samtidig behandling med lægemidler, der er potente inhibitorer af CYP3A4.
English: The active substance is tacrolimus monohydrate.
Danish: Det aktive stof er tacrolimus monohydrat.
English: LIST OF EXCIPIENTS white soft paraffin, liquid paraffin, propylene carbonate, white beeswax, hard paraffin.
Danish: hvid vaselin, paraffinolie, propylenkarbonat, hvidt voks, paraffin.
English: Tacrolimus is extensively metabolised in the liver and although blood concentrations are low following topical therapy, the ointment should be used with caution in patients with hepatic failure (see section 5.2).
Danish: Tacrolimus er ekstensivt metaboliseret i leveren, og selv om blodkoncentrationerne er lave i forbindelse med lokalbehandling, bør man udvise forsigtighed ved brug af salven til patienter med leverinsufficiens (se pkt.
English: Protopy ointment is administered topically and is unlikely to have an effect on the ability to drive or use machines.
Danish: Da Protopy salve benyttes lokalt, er det usandsynligt, at det påvirker evnen til at føre bil eller betjene maskiner.
English: The active substance of Protopy, tacrolimus monohydrate, is an immunomodulating agent.
Danish: Det aktive stof i Protopy, tacrolimus monohydrat, er et immunomodulerende lægemiddel.
English: Twice daily treatment with 0.03% tacrolimus ointment was more effective than once daily administration (Table 3).
Danish: 0,03% tacrolimus salve appliceret 2 gange om dagen var mere effektivt end applikation en gang om dagen Tabel 3).
English: Each affected region of the skin should be treated with Protopy until clearance occurs and then treatment should be discontinued.
Danish: Et afficeret hudområde skal behandles med Protopy indtil læsionen er helet, hvorefter behandlingen bør ophøre.
English: The potential for local immunosuppression (possibly resulting in infections or cutaneous malignancies) in the long term (i.e. over a period of years) is unknown (see section 5.1).
Danish: Ved langtidsbehandling (dvs. flere år) er potentialet for lokal immunosuppression (der muligvis kan medføre infektioner eller maligne hudlidelser) ukendt (se pkt.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 10 g
Danish: INDHOLDSMÆNGDE ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER
English: Two strengths of Protopy (Protopy 0.03% and Protopy 0.1% ointment) are available for adult patients (16 years of age and older).
Danish: Der findes to styrker Protopy salve (Protopy 0,03% og Protopy 0,1% salve) til brug for voksne patienter (16 år og ældre).
English: In the second trial, children aged from 2 to 15 years with moderate to severe atopic dermatitis received twice daily treatment for three weeks of 0.03% tacrolimus ointment, 0.1% tacrolimus ointment or 1% hydrocortisone acetate ointment.
Danish: I den anden kliniske afprøvning blev børn i alderen 2 år til 15 år med moderat til svær atopisk dermatitis behandlet 2 gange om dagen i 3 uger med 0,03% tacrolimus salve 0,1% tacrolimus salve eller 1% hydrokortison acetat salve.
English: Following topical application of tacrolimus ointment, tacrolimus is selectively delivered to the skin with minimal diffusion into the systemic circulation.
Danish: Efter lokal applikation af tacrolimus salve, bliver tacrolimus selektivt optaget i huden med minimal
English: Mechanism of action and pharmacodynamic effects The mechanism of action of tacrolimus in atopic dermatitis is not fully understood.
Danish: Tacrolimus virkningsmekanisme i atopisk dermatitis er ikke fuldt klarlagt.
English: The purpose of the third multicentre, double-blind, randomised study was the assessment of efficacy and safety of 0.03% tacrolimus ointment applied once or twice a day relative to twice daily administration of 1% hydrocortisone acetate ointment in children with moderate to severe atopic dermatitis.
Danish: Formålet med det tredje multicenter, dobbelt-blind, randomiserede studie var at undersøge effekt og tolerabilitet af 0,03% tacrolimus salve, når denne blev appliceret 1-2 gange om dagen sammenlignet med administrering af 1% hydrokortison acetat 2 gange om dagen til børn med moderat til svær atopisk dermatitis.
English: In a six-month multicentre double-blind randomised trial, 0.1% tacrolimus ointment was administered twice-a-day to adults with moderate to severe atopic dermatitis and compared to a topical corticosteroid based regimen (0.1% hydrocortisone butyrate on trunk and extremities, 1% hydrocortisone acetate on face and neck).
Danish: I en seks-måneders multicenter, dobbelt-blind, randomiseret afprøvning blev 0,1% tacrolimus salve administreret 2 gange om dagen til voksne med moderat til svær atopisk dermatitis, og blev sammenlignet med lokal kortikosteroid behandling (0,1% hydrokortison butyrat på kroppen og ekstremiteter og 1% hydrokortison acetat på ansigt og hals).
English: The effect of treatment with Protopy ointment on the developing immune system of children, especially the young, has not yet been established and this should be taken into account when prescribing to this age group (see section 4.1).
Danish: Virkningen af behandling med Protopy salve på det ikke færdigudviklede immunsystem hos børn, specielt mindre børn, kendes endnu ikke, hvilket må tages med i overvejelserne ved ordination til
English: You should inform your doctor if you have swollen lymph nodes at initiation of treatment.
Danish: De skal tale med lægen, hvis De har hævede lymfekirtler før behandlingen startes.
English: Facial flushing or skin irritation after drinking alcohol is also common.
Danish: Hudrødmen (flushing) eller hudirritation er også almindeligt efter indtagelse af alkohol.
English: The effect of treatment with Protopy on the developing immune system in children, especially
Danish: Virkningen af behandlingen med Protopy salve på det ikke færdigudviklede immunsystem hos
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Danish: Indenfor hver gruppe af bivirkninger med samme frekvens skal bivirkningerne opstilles efter hvor alvorlige bivirkningerne er.
English: Use in elderly (65 years of age and above)
Danish: Behandling af ældre (65 år gamle og ældre)
English: The safety of Protopy ointment has not been established in patients with generalised erythroderma.
Danish: Protopys tolerabilitet ved behandling af patienter med generaliseret erythrodermi er ikke undersøgt.
English: Slightly lower body weight gain in females was the only systemic change observed in micropigs at high ointment concentrations (3%).
Danish: En noget mindre øgning af kropsvægten i hundyr var eneste tegn på systemisk eksponering i minigrise ved brug
English: Always use Protopy exactly as your doctor has told you.
Danish: Protopy bør altid anvendes i nøje overensstemmelse med Deres læges instruktioner.
English: Human data demonstrate that, after systemic administration, tacrolimus is excreted into breast milk.
Danish: Efter systemisk administrering udskilles tacrolimus i modermælken.
English: In a 24-month dermal carcinogenicity study performed in mice with 0.1% ointment, no skin tumours were observed.
Danish: Man fandt ingen hudtumorer i en 24 måneders undersøgelse af dermal carcinogenicitet på mus hvor man benyttede 0,1% salve.
English: Protopy is available in two strengths, Protopy 0.03% and Protopy 0.1% ointment.
Danish: Protopy findes i 2 styrker, Protopy 0,03% og Protopy 0,1% salve.
English: Treatment should be started with Protopy 0.1% twice a day and treatment should be continued until clearance of the lesion.
Danish: Behandlingen bør begynde med Protopy 0,1% to gange om dagen indtil læsionen er helet.
English: Tacrolimus is not metabolised in human skin, indicating that there is no potential for percutaneous interactions that could affect the metabolism of tacrolimus.
Danish: Da tacrolimus ikke metaboliseres i huden, er der intet potentiale for perkutane interaktioner, der ville
English: However, a link to Protopy ointment treatment has not been confirmed or refuted on the available evidence so far.
Danish: På basis af de beviser, der er tilgængelige indtil videre, er en sammenhæng med behandlingen med Protopy salve imidlertid ikke blevet bekræftet eller modbevist.
English: A statistically significant better improvement was shown for once daily and twice daily 0.03% tacrolimus ointment compared to twice daily hydrocortisone acetate ointment (p<0.001 for both).
Danish: En statistisk signifikant øget bedring blev vist for administration en gang om dagen og for administrering af 0,03% tacrolimus salve to gange om dagen i sammenligning med administrering af 1% hydrokortison acetat salve (p< 0,001 for begge).
English: There were no clinically relevant changes in the laboratory values or vital signs in either treatment group throughout the study.
Danish: Der var ingen klinisk relevante ændringer i laboratorieværdier eller i puls og blodtryk i nogen af grupperne i løbet af studiets.
English: • CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2).
Danish: Lægemidlet må kun udleveres efter begrænset recept (jf. bilag I: Produktresumé; pkt.
English: POSSIBLE SIDE EFFECTS
Danish: Den potentielle risiko for
English: Two strengths of Protopy (Protopy 0.03% and Protopy 0.1% ointment) are available for adult patients.
Danish: Der findes to styrker Protopy salve (Protopy 0,03% og Protopy 0,1% salve) til brug for voksne patienter.
English: Protopy 0.03% ointment is used to treat moderate to severe atopic dermatitis (eczema) in adults who are not adequately responsive to or are intolerant of conventional therapies such as topical corticosteroids and in children (2 years of age and older) who failed to respond adequately to conventional therapies such as topical corticosteroids.
Danish: Protopy 0,03% salve benyttes til at behandle moderat til svær atopisk dermatitis (eksem) hos voksne, der ikke responderer tilfredsstillende på eller ikke tåler konventionelle behandlinger såsom topikale kortikosteroider og til børn (2 år og ældre), der ikke har responderet tilfredsstillende på konventionel behandling såsom topikale kortikosteroider.
English: Protopy 0.1% Ointment Tacrolimus monohydrate
Danish: Protopy 0,1% salve Tacrolimus monohydrat
English: In the presence of these infections, the balance of risks and benefits associated with Protopy use should be evaluated.
Danish: Man bør tage disse infektioner i betragtning når man vurderer risici og
English: Global Evaluation § Topical corticosteroid regimen = 0.1% hydrocortisone butyrate on trunk and extremities, 1% hydrocortisone acetate on face and neck §§ higher values = greater improvement
Danish: § Lokal kortikosteroidbehandling = 0,1% hydrokortison butyrat på krop og ekstremiteter, 1%
English: Clinical data have shown that tacrolimus concentrations in systemic circulation after topical administration are low and, when measurable, transient.
Danish: Kliniske data har vist, at koncentrationen af tacrolimus i den systemiske cirkulation er lav efter applikation på huden, og i de tilfælde koncentrationen har været målelig, kun målelig i kortere
English: Astellas Pharma GmbH Neumarkter Str. 61 D-81673 München Germany
Danish: Astellas Pharma GmbH Neumarkter Str. 61 D-81673 München Tyskland
English: Treatment of moderate to severe atopic dermatitis in children (2 years of age and above) who failed to respond adequately to conventional therapies such as topical corticosteroids.
Danish: Behandling af moderat til svær atopisk dermatitis hos børn (2 år og ældre), der ikke har responderet tilfredsstillende på konventionelle behandlinger såsom topikale kortikosteroider.
English: The expiry date refers to the last day of that month.
Danish: Anvend ikke efter udløbsdatoen, som er angivet på tuben og æsken efter EXP. Udløbsdatoen referer til den sidste dag i den pågældende måned.
English: Application site warmth, application site erythema, application site pain, application site irritation, application site paraesthesia, application site rash
Danish: Almene lidelser og reaktioner på indgivelsesstedet Meget almindelig: Brænden på applikationsstedet, kløe på applikationsstedet Varme på applikationsstedet, erythem på applikationsstedet, smerte på applikationsstedet, irritation på applikationsstedet, paræstesi på applikationsstedet,
English: Emollients should not be applied to the same area within 2 hours of applying Protopy ointment.
Danish: Blødgørende cremer bør ikke benyttes på et behandlet hudområde fra 2 timer før til 2 timer efter påsmøring af Protopy salve.
English: Formal topical drug interaction studies with tacrolimus ointment have not been conducted.
Danish: Der er ikke udført formelle lokale interaktionsstudier med Protopy salve.
English: Erythema was a common skin irritation adverse reaction.
Danish: Erythema er almindeligt rapporterede bivirkninger.
English: Before commencing treatment with Protopy ointment, clinical infections at treatment sites should be cleared.
Danish: Før man starter behandling med Protopy salve skal alle områder med klinisk inficeret atopisk dermatitis være helede.
English: Protopy ointment should be applied as a thin layer to affected areas of the skin.
Danish: Protopy salve skal påsmøres i et tyndt lag på det afficerede hudområde.
English: Treatment of moderate to severe atopic dermatitis in adults who are not adequately responsive to or are intolerant of conventional therapies such as topical corticosteroids.
Danish: Behandling af moderat til svær atopisk dermatitis hos voksne, der ikke responderer tilfredsstillende på eller ikke tåler konventionelle behandlinger såsom topikale kortikosteroider.
English: A MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
Danish: A. INDEHAVER AF VIRKSOMHEDSGODKENDELSE ANSVARLIG FOR BATCHFRIGIVELSE
English: Protopy alters the abnormal immune response and relieves the skin inflammation and the itch.
Danish: Protopy dæmper den unormale hudreaktion og lindrer
English: Please consult your doctor.
Danish: De bør konsultere
English: PHARMACEUTICAL FORM AND CONTENTS Ointment
Danish: LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE)
English: Protopy 0.03% Ointment Tacrolimus monohydrate
Danish: Protopy 0,03% salve Tacrolimus monohydrat
English: Protopy ointment should not be applied to lesions that are considered to be potentially malignant or pre-malignant.
Danish: Protopy salve må ikke anvendes på læsioner som bedømmes for
English: Protopy 0.1% ointment is used to treat moderate to severe atopic dermatitis (eczema) in adults who are not adequately responsive to or are intolerant of conventional therapies such as topical corticosteroids.
Danish: Protopy 0,1% salve benyttes til at behandle moderat til svær atopisk dermatitis (eksem) hos voksne, der ikke responderer tilfredsstillende på eller ikke tåler konventionelle behandlinger såsom topikale kortikosteroider.
English: In patients using tacrolimus ointment, cases of malignancies, including cutaneous and other types of lymphoma, and skin cancers have been reported (see section 4.8).
Danish: hud og andre typer lymfom hos patienter, som bruger tacrolimus salve (se pkt 4.8).
English: Marketing Authorisation Holder: Astellas Pharma GmbH, Neumarkter Str. 61, D-81673 München, Germany.
Danish: Indehaveren af markedsføringstilladelsen: Astellas Pharma GmbH, Neumarkter Str. 61, D-81673
English: An attempt should be made to reduce the frequency of application or to use the lower strength Protopy 0.03% ointment if the clinical condition allows.
Danish: Hvis den kliniske tilstand tillader det, bør man forsøge at reducere hyppigheden af applikationer eller benytte den svagere Protopy 0,03% salve.
English: Propylene carbonate
Danish: Paraffinolie
English: Post-marketing: cases of malignancies, including cutaneous and other types of lymphoma, and skin cancers, have been reported in patients using tacrolimus ointment (see section 4.4).
Danish: kutane og andre typer lymfomer og hudcancer hos patienter behandlet med tacrolimus salve (se pkt.
English: NAME OF THE MEDICINAL PRODUCT Protopy 0.1% Ointment
Danish: LÆGEMIDLETS NAVN Protopy 0,1% salve
English: NAME OF THE MEDICINAL PRODUCT Protopy 0.03% ointment
Danish: LÆGEMIDLETS NAVN Protopy 0,03% salve
English: What Protopy looks like and contents of the pack Protopy is a white to slightly yellowish ointment.
Danish: Protopy er en hvid, lidt gullig salve.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION 1 g of Protopy 0.03% ointment contains 0.3 mg of tacrolimus as tacrolimus monohydrate (0.03%).
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING 1 g Protopy 0,03% salve indeholder 0,3 mg tacrolimus som tacrolimus monohydrat (0,03%).
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Danish: Navn og adresse på fremstilleren ansvarlig for batchfrigivelse
English: Protopy is available in two strengths (Protopy 0.03% and Protopy 0.1% ointment).
Danish: Protopy findes i to styrker (Protopy 0,03% og
English: QUALITATIVE AND QUANTITATIVE COMPOSITION 1 g of Protopy 0.1% ointment contains 1.0 mg of tacrolimus as tacrolimus monohydrate (0.1%).
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING 1 g Protopy 0,1% salve indeholder 1,0 mg tacrolimus som tacrolimus monohydrat (0,1%).
English: Astellas Pharma B.V. Elisabethhof 19
Danish: Elisabethhof 19
English: Protopy should not be used in patients with congenital or acquired immunodeficiencies or in patients on therapy that cause immunosuppression.
Danish: 4.4 Særlige advarsler og forsigtighedsregler vedrørende brugen Protopy må ikke anvendes til patienter med medfødt eller erhvervet immundefekt eller til patienter i
English: Although clinical data have shown that systemic exposure from application of tacrolimus ointment is low, breast-feeding during treatment with Protopy ointment is not recommended.
Danish: Selv om den systemiske eksponering er lav ved brug af Protopy salve bør kvinder i behandling med Protopy salve ikke amme.
English: One gram of Protopy 0.1% ointment contains 1.0 mg tacrolimus (as tacrolimus monohydrate).
Danish: Et gram af Protopy 0,1% salve indeholder 1,0 mg tacrolimus (som tacrolimus monohydrat).
English: One gram of Protopy 0.03% ointment contains 0.3 mg tacrolimus (as tacrolimus monohydrate).
Danish: Et gram af Protopy 0,03% salve indeholder 0,3 mg tacrolimus (som tacrolimus monohydrat).
English: While using Protopy, drinking alcohol may cause the skin or face to become flushed or red and feel hot.
Danish: Hvordan man anvender Protopy sammen med mad og drikkevarer Når man er i behandling med Protopy, kan indtagelse af alkohol medføre pludselig rødmen (flush) og
English: Metabolism
Danish: Mutagenicitet
English: BEFORE YOU USE PROTOPY
Danish: Hvad De skal gøre, før De begynder at anvende Protopy
English: If you have liver failure.
Danish: Hvis De har nedsat leverfunktion.
English: Cutaneous use
Danish: Teratogenicitet
English: Astellas Pharma S.A.
Danish: Astellas Pharma B.V.
English: Paraesthesias and dysaesthesias (hyperaesthesia, burning sensation) Metabolism and nutrition disorders Common:
Danish: Paræstesi og dysæstesi (hyperæsthesi brændende følelse)
English: Alcohol intolerance (facial flushing or skin irritation after consumption of an
Danish: Alkoholintolerance (flushing eller hudirritation efter indtagelse af alkohol) Følgende bivirkninger er blevet rapporteret efter markedsføringen:
English: STATEMENT OF ACTIVE SUBSTANCE 1 g ointment contains: 0.3 mg tacrolimus (as monohydrate),
Danish: 1 g salve indeholder: 0,3 mg tacrolimus (som monohydrat),
English: STATEMENT OF ACTIVE SUBSTANCE 1 g ointment contains: 1.0 mg tacrolimus (as monohydrate),
Danish: 1 g salve indeholder: 1,0 mg tacrolimus (som monohydrat),
English: Nervous system disorders Common:
Danish: Protopy dæmper den unormale
English: Apply Protopy as a thin layer to affected areas of your skin.
Danish: Påsmør Protopy i et tyndt lag på de angrebne hudområder.
English: At the first signs of recurrence (flares) of the disease symptoms, treatment should be reinitiated.
Danish: Behandling bør genoptages ved de første tegn på tilbagevenden
English: You should check with your doctor or pharmacist if you are not sure.
Danish: Kontakt Deres læge eller apotek, hvis De har yderligere spørgsmål.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING PROTOPY 0.1% OINTMENT (30 g, 60 g TUBE)
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE PROTOPY 0,1% SALVE (30 g, 60 g TUBE)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING PROTOPY 0.1% OINTMENT (10 g, 30 g, 60 g CARTON)
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE PROTOPY 0,1% SALVE (10 g, 30 g, 60 g YDRE EMBALLAGE)
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING PROTOPY 0.03% OINTMENT (30 g, 60 g TUBE)
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE PROTOPY 0,03% SALVE (30 g, 60 g TUBE)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING PROTOPY 0.03% OINTMENT (10 g, 30 g, 60 g CARTON)
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE PROTOPY 0,03% SALVE (10 g, 30 g, 60 g YDRE EMBALLAGE)
English: Before receiving a vaccination tell your doctor that you are using Protopy.
Danish: Nævn for lægen at De bruger Protopy før De skal vaccineres.
English: GENERAL CLASSIFICATION FOR SUPPLY Medicinal product subject to medical prescription.
Danish: Yderligere information om dette lægemiddel er tilgængelig på Det europæiske Lægemiddelagenturs
English: 6.1 List of excipients
Danish: FARMACEUTISKE OPLYSNINGER 6.1 Fortegnelse over hjælpestoffer Hvid vaselin
English: This leaflet was last approved in {MM/YYYY}
Danish: Denne indlægsseddel blev senest godkendt den {MM/ÅÅÅÅ} Yderligere information om dette lægemiddel er tilgængelig på Det europæiske Lægemiddelagenturs
English: This summary was last updated in 10-2006.©EMEA 2006
Danish: Dette sammendrag blev sidst ajourført i 10-2006..©EMEA 2006
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Ultratard to Novo Nordisk A/S in on 7 October 2002.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Ultratard til Novo Nordisk A/S den 7. oktober 2002.
English: Other information about Ultratard:
Danish: Andre oplysninger om Ultratard:
English: It explains how the Committee for Medicinal products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.
Danish: Det forklarer, hvordan Udvalget for Humanmedicinske Lægemidler (CHMP) vurderede de gennemførte undersøgelser og nåede frem til sine anbefalinger om, hvordan lægemidlet skal anvendes.
English: The Committee for Medicinal products for Human Use (CHMP) decided that Ultratard's benefits are greater than its risks for the treatment of diabetes.
Danish: Udvalget for Humanmedicinske Lægemidler (CHMP) besluttede, at fordelene ved Ultratard er større end risiciene ved behandling af diabetes.
English: The patient's blood sugar should be tested regularly to find the lowest effective dose.
Danish: Patientens blodsukker skal kontrolleres regelmæssigt for at fastsætte den effektive minimumsdosis.