FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients with abnormal baseline renal function should initially be treated with 2.5 mg/kg/day and must be monitored very carefully.
Danish: Yderligere forsigtighedsregler ved nefrotisk syndrom Patienter med abnorm nyrefunktion ved baseline behandles initialt med 2,5 mg/kg/dag og skal monitoreres meget nøje.
English: Products containing Hypericum perforatum (St John´s Wort) must not be used concomitantly with Sandimmun due to the risk of decreased blood levels of ciclosporin and thereby reduced effect (see section 4.3).
Danish: Produkter, der indeholder Hypericum perforatum (perikon,) må ikke bruges samtidig med Sandimmun pga. risikoen for nedsættelse af plasmakoncentrationen af ciclosporin og dermed reduceret effekt (se pkt.
English: This is equivalent to nearly 15 ml beer or 5 ml wine.
Danish: Det svarer til næsten 15 ml øl eller 5 ml vin.
English: Infusion is continued at this dose level during the immediate post-transplant period of up to 2 weeks, before a change is made to oral maintenance therapy with Sandimmun at daily doses of about 12.5 mg/kg given in 2 divided doses.
Danish: Infusion fortsætter i dette dosisniveau i den nærmeste post-transplantale periode i op til 2 uger, før der skiftes over til oral vedligeholdelsesbehandling med Sandimmun i en daglig dosis på ca. 12,5 mg/kg/døgn fordelt på 2 doser.
English: In particular tell your doctor or pharmacist if you are taking any of the following medicines before or during Sandimmun treatment:
Danish: Du skal især fortælle det til din læge, hvis du har taget følgende medicin inden eller i løbet af behandlingen med Sandimmun:
English: If you are being treated for Behçet`s uveitis, your doctor will monitor you particularly carefully if you have neurological symptoms (for example: increased forgetfulness, personality changes noticed over time, psychiatric or mood disorders, burning sensation in limbs, decreased sensation in limbs, tingling sensation in limbs, weakness of limbs, walking disturbances, headache with or without nausea and vomiting, vision disturbances including restricted movement of eyeball).
Danish: Hvis du behandles for Behçets uveitis, vil din læge overvåge din sygdom særlig omhyggeligt hvis du har neurologiske symptomer (fx: øget glemsomhed, personlighedsændringer, som bemærkes gradvis, psykiske eller humørrelaterede forstyrrelser, brændende fornemmelse i arme og ben, nedsat følesans i arme og ben, snurrende fornemmelse i arme og ben, svækkede arme og ben, gangbesvær, hovedpine med eller uden kvalme og opkastning, synsforstyrrelser, inklusive begrænset bevægelse af øjeæblerne).
English: The recommended intravenous dose is 3 to 5 mg/kg/day.
Danish: Den anbefalede intravenøse dosis er 35 mg/kg/dag.
English: Following oral administration of Sandimmun peak blood concentrations are reached within 1 to 6 hours.
Danish: Efter oral administration af Sandimmun nås peak-plasmakoncentrationen af ciclosporin inden for 16 timer.
English: Thrombotic microangiopathy, thrombotic thrombocytopenic purpura Metabolism and nutrition disorders
Danish: Trombotisk mikroangiopati, trombotisk trombocytopenisk purpura Metabolisme og ernæring
English: - Close the bottle with the cap provided.
Danish: - Flasken lukkes med den medfølgende hætte.
English: Do not use Sandimmum and tell your doctor if the above applies to you.
Danish: Tag ikke Sandimmun, og fortæl det til din læge, hvis noget af ovenstående gælder for dig.
English: METHOD OF ADMINISTRATION [To be completed nationally]
Danish: ADMINISTRATIONSMETODE [Udfyldes nationalt]
English: Do not stop taking Sandimmun unless your doctor tells you to.
Danish: Hold ikke op med at tage Sandimmun, medmindre din læge siger det.
English: Encephalopathy including Posterior Reversible Encephalopathy Syndrome (PRES), signs and symptoms such as convulsions, confusion, disorientation, decreased responsiveness, agitation, insomnia, visual disturbances, cortical blindness, coma, paresis and cerebellar ataxia
Danish: Ikke almindelig Encefalopati, inklusive posterior reversibelt encefalopati-syndrom (PRES), tegn og symptomer som kramper, konfusion, disorientering, nedsat reaktionsevne, agitation, søvnløshed, synsforstyrrelser, kortikal blindhed, koma, parese, cerebellar ataksi
English: What Sandimmun looks like and contents of the pack Sandimmun concentrate for solution for infusion is supplied in ampoules containing 1 ml or 5 ml concentrate.
Danish: Sandimmun koncentrat til infusionsvæske leveres i ampuller indeholdende 1 ml eller 5 ml koncentrat.
English: There have been solicited and spontaneous reports of hepatotoxicity and liver injury including cholestasis, jaundice, hepatitis and liver failure in patients treated with ciclosporin.
Danish: Der har været velunderbyggede og spontane rapporter om hepatotoksicitet og leverskade, herunder kolestase, gulsot, hepatitis og leversvigt hos patienter, der blev behandlet med ciclosporin.
English: Talk to your doctor before taking Sandimmun:
Danish: Tal med din læge, før du tager Sandimmun:
English: In non-transplant patients, occasional monitoring of ciclosporin blood levels is recommended, e.g. when Sandimmun is co-administered with substances that may interfere with the pharmacokinetics of ciclosporin, or in the event of unusual clinical response (e.g. lack of efficacy or increased drug intolerance such as renal dysfunction).
Danish: Hos ikke-transplanterede patienter anbefales lejlighedsvis monitorering af ciclosporinkoncentrationsen, f.eks. når Sandimmun administreres sammen med lægemidler, der kan påvirke ciclosporins farmakokinetik, eller i tilfælde af udsædvanlig klinisk respons (f.eks. manglende effekt eller øget lægemiddelintolerance som renal dysfunktion).
English: Multiple dose administration of ambrisentan and ciclosporin in healthy volunteers resulted in an approximately 2-fold increase in ambrisentan exposure, while the ciclosporin exposure was marginally increased (approximately 10%).
Danish: Administration af multiple doser af ambrisentan og ciclosporin hos raske frivillige resulterede i en cirka 2-fold stigning i eksponeringen for ambrisentan, mens eksponeringen for ciclosporin kun var marginalt øget (ca. 10%).
English: If Sandimmun concentrate for solution for infusion is used, the recommended dose is approximately one-third of the corresponding Sandimmun oral dose, and it is recommend that patients be switched to oral therapy as soon as possible.
Danish: Hvis Sandimmun koncentrat til infusionsvæske bruges, er den anbefalede dosis ca. en tredjedel af den tilsvarende Sandimmun orale dosis.
English: Tabulated summary of adverse drug reactions from clinical trials Adverse drug reactions from clinical trials (Table 1) are listed by MedDRA system organ class.
Danish: Bivirkningerne fra kliniske studier (Tabel 1) er ordnet efter systemorganklasser i henhold til MedDRA.
English: Occasional monitoring of ciclosporin blood levels may be relevant in non-transplant indications, e.g. when Sandimmun is co-administered with substances that may interfere with the pharmacokinetics of ciclosporin, or in the event of unusual clinical response (e.g. lack of efficacy or increased drug intolerance such as renal dysfunction).
Danish: Lejlighedsvis monitorering af ciclosporinniveau i blodet kan være relevant for andre indikationer end transplantation, f.eks. når Sandimmun administreres sammen med lægemidler, der kan påvirke ciclosporins farmakokinetik, eller ved usædvanlig klinisk respons (f.eks. manglende effekt eller øget lægemiddelintolerance som renal dysfunktion).
English: Its use in children under 16 years of age for non-transplantation indications other than nephrotic syndrome cannot be recommended.
Danish: Det anbefales ikke til brug hos børn under 16 år ved andre indikationer end transplantation, undtagen nefrotisk syndrom.
English: This is equivalent to nearly 15 ml beer or 5 ml wine per dose.
Danish: Dette svarer til næsten 15 ml øl eller 5 ml vin pr. dosis.
English: • Symptoms of brain disorders including sudden fits, mental confusion, sleeplessness,
Danish: • Symptomer på hjernesygdom inklusive pludselige krampeanfald, forvirring, søvnløshed,
English: Azitromycin increases ciclosporin levels by around 20%.
Danish: Azitromycin øger ciclosporins plasmakoncentration med omkring 20%.
English: Cases of acute nephrotoxicity reported disorders of ion homeostasis, such as hyperkalaemia, hypomagnesaemia, and hyperuricaemia.
Danish: Tilfælde af akut nefrotoksicitet rapporterede forstyrrelser i ionbalancen, som f.eks. hyperkaliæmi, hypomagnesiæmi og hyperurikæmi.
English: disorientation, disturbance of vision, unconsciousness, sense of weakness in the limbs, impaired movements.
Danish: desorientering, synsforstyrrelser, bevidsthedstab, følelse af svage arme og ben, nedsat bevægelighed.
English: Special caution should be observed if Sandimmun is used in combination with methotrexate due to nephrotoxic synergy.
Danish: Pga. nefrotoksisk synergi skal der udvises særlig forsigtighed, hvis Sandimmun anvendes sammen med methotrexat.
English: Caution is recommended when co-administering ciclosporin with lercanidipine (see section 4.4).
Danish: Forsigtighed anbefales ved samtidig administration af ciclosporin og lercanidipin (se pkt.
English: A decision should be made whether to abstain from breast-feeding or to abstain from using the medicinal drug, taking into account the importance of the medicinal product to the mother.
Danish: Det skal besluttes, om amning eller behandling med Sandimmun skal ophøre, idet der tages højde for de terapeutiske fordele for moderen.
English: Nausea, vomiting, abdominal discomfort/pain, diarrhoea, gingival hyperplasia, peptic ulcer
Danish: Almindelig Kvalme, opkastning, abdominal ubehag/smerte, diaré, gingival hyperplasi,
English: Sandimmun and associated names (see Annex I) 25 mg soft capsules Sandimmun and associated names (see Annex I) 50 mg soft capsules Sandimmun and associated names (see Annex I) 100 mg soft capsules [See Annex I - To be completed nationally]
Danish: Sandimmun og relaterede navne (se Bilag I) 25 mg bløde kapsler Sandimmun og relaterede navne (se Bilag I) 50 mg bløde kapsler Sandimmun og relaterede navne (se Bilag I) 100 mg bløde kapsler [Se bilag I - Udfyldes nationalt]
English: Hyperglycaemia, anorexia, hyperuricaemia, hyperkalaemia, hypomagnesaemia Nervous system disorders
Danish: Almindelig Hyperglykæmi, appetitmangel, hyperurikæmi, hyperkaliæmi, hypomagnesiæmi Nervesystemet
English: Atopic dermatitis
Danish: Atopisk dermatitis
English: PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for infusion containing 50 mg ciclosporin per mL.
Danish: LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE) Koncentrat til infusionsvæske, opløsning indeholdende 50 mg ciclosporin per ml.
English: Maize oil refined
Danish: Majsolie, rafineret
English: Because of the risk of anaphylaxis (see section 4.4) the use of Sandimmun concentrate for solution for infusion should be reserved for organ transplant patients who are unable to take the medicinal product orally (e.g. shortly after surgery), or in whom absorption of the oral forms might be impaired during episodes of gastrointestinal disorders.
Danish: 4.4) bør Sandimmun koncentrat til infusionsvæske forbeholdes organtransplanterede patienter, der ikke kan tage lægemidlet oralt (f.eks. kort efter operation), eller patienter, hvor absorptionen af orale lægemiddelformer kan være hæmmet på grund af gastrointestinale lidelser.
English: BATCH NUMBER [To be completed nationally]
Danish: BATCHNUMMER [Udfyldes nationalt]
English: • if you develop high blood pressure.
Danish: • hvis du får for højt blodtryk.
English: Caution should be observed when co-administering ciclosporin with drugs that substantially increase or decrease ciclosporin plasma concentrations, through inhibition or induction of CYP3A4 and/or Pglycoprotein (see section 4.5).
Danish: Der bør udvises forsigtighed, når ciclosporin administreres sammen med lægemidler, der væsentligt øger eller reducerer ciclosporins plasmakoncentration ved at hæmme eller inducere CYP3A4 og/eller P-glykoprotein (se pkt.
English: Oedema, weight increase * Adverse events reported from post marketing experience where the ADR frequency is not known due to the lack of a real denominator.
Danish: Ikke almindelig Ødem, vægtøgning * Bivirkninger rapporteret efter markedsføring, hvor bivirkningsfrekvensen ikke kendes, da den reelle nævner er ukendt.
English: Your daily doses should always be taken in 2 divided doses.
Danish: Sådan skal du tage Sandimmun Din daglige dosis skal altid fordeles på 2 doser.
English: Combination with medicines that are substrates for the multidrug efflux transporter P-glycoprotein or the organic anion transporter proteins (OATP) and for which elevated plasma concentrations are associated with serious and/or life-threatening events, e.g. bosentan, dabigatran etexilate and aliskiren (see section 4.5).
Danish: Kombination med lægemidler, der er substrater af multilægemiddel-effluks-transporteren Pglykoprotein eller organisk aniontransporter-proteiner (OATP), og hvor forhøjede plasmakoncentrationer er forbundet med alvorlige og/eller livstruende bivirkninger, f.eks. bosentan, dabigatranetexilat og aliskiren (se pkt.
English: Each mark on the syringe is 0.05
Danish: Hver afmærkning på sprøjten svarer til 0,05 ml.
English: Close the bottle with the cap provided.
Danish: Flasken lukkes med den medfølgende prop.
English: This is because this medicine contains alcohol (see section below “Sandimmun conatins castor oil and ethanol”).
Danish: Det skyldes, at denne medicin indeholder alkohol (se punktet ”Sandimmun indeholder polyoxyleret ricinusolie og ethanol”).
English: The concentrate for solution for infusion should be diluted 1:20 to 1:100 with normal saline or 5% glucose and given as a slow intravenous infusion over 2 to 6 hours.
Danish: Koncentrat til infusionsvæske skal fortyndes 1:20 til 1:100 med isotonisk natriumchloridinfusionsvæske eller 5 % glucoseinfusionsvæske og gives som langsom i.v.-infusion over 2-6 timer.
English: Statin therapy needs to be temporarily withheld or discontinued in patients with signs and symptoms of myopathy or those with risk factors predisposing to severe renal injury, including renal failure, secondary to rhabdomyolysis.
Danish: Statinbehandling skal midlertidigt pauseres eller seponeres hos patienter med tegn og symptomer på myopati og hos patienter med risikofaktorer, der prædisponerer til alvorlig nyreskade, inklusive nyresvigt, sekundært til rabdomyolyse.
English: Choose the syringe depending on the prescribed volume.
Danish: Vælg sprøjten, der passer til den ordinerede dosis.
English: Acute and chronic nephrotoxicity
Danish: Akut og kronisk nefrotoksicitet
English: PHARMACEUTICAL FORM AND CONTENTS Oral solution containing 100 mg ciclosporin per mL
Danish: LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE) Oral opløsning indeholdende 100 mg ciclosporin per ml
English: Types of containers suitable for the infusion solution are mentioned in section 6.2.
Danish: Hensigtsmæssige beholdere til infusionsvæsken er beskrevet i pkt.
English: However, due to its nephrotoxic potential (see section 4.8), careful monitoring of renal function is recommended (see section 4.4).
Danish: 4.8) anbefales det dog, at nyrefunktionen monitoreres nøje (se pkt.
English: Hirsutism
Danish: Hirsutisme
English: The normal route of administration is by mouth.
Danish: Den normale indgivelsesmåde er oral indgift.
English: Treatment with Sandimmun should be initiated within 12 hours before surgery at a dose of 10 to 15 mg/kg given in 2 divided doses.
Danish: Behandling med Sandimmun skal påbegyndes inden for 12 timer før operationen med oral en dosis på 10-15 mg/kg fordelt på 2 doser.
English: There is a high variability in the data reported on the terminal half-life of ciclosporin depending on the assay applied and on the target population.
Danish: Der er stor variation i de foreliggende data om ciclosporins terminale halveringstid afhængig af den anvendte analyse og målpopulationenen.
English: This dose should be maintained as the daily dose for 1 to 2 weeks post-operatively, being gradually reduced in accordance with blood levels according to local immunosuppressive protocols until a recommended maintenance dose of about 2 to 6 mg/kg given in 2 divided doses is reached.
Danish: Denne døgndosis bør opretholdes i 1-2 uger efter operationen, hvorefter døgndosis reduceres gradvist ud fra måling af plasmakoncentrationen i henhold til lokale protokoller for immunsuppressiv behandling, indtil en anbefalet oral vedligeholdelsesdosis på ca. 26 mg/kg fordelt på 2 doser er nået.
English: Nicardipine, metoclopramide, oral contraceptives, methylprednisolone (high dose), allopurinol, cholic acid and derivatives, protease inhibitors, imatinib, colchicine, nefazodone.
Danish: F.eks.: Nicardipin, metoclopramid, oral kontraception, methylprednisolon (høj dosis), allopurinol, cholsyre og cholsyrederivater, proteasehæmmere, imatinib, colchicin, nefazodon.
English: How much Sandimmun you will be given
Danish: Så meget Sandimmun vil du få
English: If you get high blood pressure during treatment and it cannot be controlled, Sandimmun should be stopped by your doctor.
Danish: Hvis du får for højt blodtryk i løbet af behandlingen, og det ikke kan kontrolleres, skal behandlingen med
English: Your doctor will adjust your dose to one that is ideal for you.
Danish: Lægen vil justere din dosis, så den passer til dig.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS BLISTERS
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIPS BLISTER
English: • Acne, hot flushes.
Danish: • Akne, hedeture.
English: Statin therapy needs to be temporarily withheld or discontinued in patients with signs and symptoms of myopathy or those with risk factors predisposing to severe renal injury, including renal failure, secondary to rhabdomyolysis (see section
Danish: Statinbehandling skal midlertidigt afbrydes eller seponeres hos patienter med tegn og symptomer på myopati og hos patienter med risikofaktorer, der prædisponerer til alvorlig nyreskade, inklusive nyresvigt, sekundært til rabdomyolyse (se pkt.
English: Insert the nozzle of the syringe into the white stopper.
Danish: Isæt spidsen af sprøjten i den hvide prop.
English: One ml oral solution contains 100 mg ciclosporin.
Danish: En ml oral opløsning indeholder 100 mg ciclosporin.
English: If any of these affects you severely, tell your doctor.
Danish: Hvis nogle af disse bivirkninger påvirker dig i alvorlig grad, skal du sige det til din læge.
English: Ciclosporin passes into breast milk.
Danish: Ciclosporin udskilles i humanmælk.
English: Caution is required with concomitant use of potassium-sparing medicinal products (e.g. potassiumsparing diuretics, ACE inhibitors, angiotensin II receptor antagonists) or potassium-containing medicinal products since they may lead to significant increases in serum potassium (see section 4.4).
Danish: kaliumbesparende diuretika, ACE-hæmmere, angiotensin II-receptorantagonister) eller lægemidler indeholdende kalium, da disse kan medføre signifikant stigning i serumkalium (se pkt.
English: If the effect is insufficient, the daily dose may then be increased gradually as tolerability permits, but should not exceed 5 mg/kg.
Danish: Hvis effekten ikke er tilstrækkelig, kan dosis gradvis øges afhængigt af tolerbiliteten, men bør ikke overstige 5 mg/kg/dag.
English: Liver problems.
Danish: • Leverproblemer.
English: Sandimmun contains ethanol
Danish: Sandimmun indeholder ethanol.
English: What Sandimmun looks like and contents of the pack Sandimmun 25 mg soft capsules are pink and oval.
Danish: Udseende og pakningsstørrelser Sandimmun 25 mg bløde kapsler er pink og ovale.
English: Barbiturates, carbamazepine, oxcarbazepine, phenytoin; nafcillin, intravenous sulfadimidine, probucol, orlistat, hypericum perforatum (St. John's wort), ticlopidine, sulfinpyrazone, terbinafine, bosentan.
Danish: Barbiturater, carbamazepin, oxcarbazepin, phenytoin; nafcillin, intravenøs sulfadimidin; probucol, orlistat, perikon, ticlopidin, sulfinpyrazon, terbinafin, bosentan.
English: Sandimmun 100 mg soft capsules are dusty rose and oblong.
Danish: Sandimmun 100 mg bløde kapsler er støvet røde og aflange.
English: The concentrate should be diluted 1:20 to 1:100 with normal saline or 5% glucose, and given as a slow intravenous infusion over approximately 2 to 6 hours.
Danish: Sandimmun koncentrat til infusionsvæske skal fortyndes til mellem 1:20 og 1:100 med isotonisk natriumchloridinfusionsvæske eller 5 % glucoseinfusionsvæske og gives som langsom intravenøs infusion over ca. 2 til 6 timer.
English: Do not take Sandimmun with grapefruit or grapefruit juice.
Danish: Få ikke Sandimmun sammen med grapefrugt eller grapejuice, da det kan påvirke virkningen af Sandimmun.
English: Combination with products containing Hypericum perforatum (St John´s Wort) (see section 4.5).
Danish: Kombination med produkter, der indeholder Hypericum perforatum (perikon) (se pkt.
English: In patients with impaired renal function, the initial dose should not exceed 2.5 mg/kg/day.
Danish: Hos patienter med nedsat nyrefunktion bør initialdosis ikke overstige 2,5 mg/kg/dag.
English: How to store Sandimmun
Danish: Beskrivelse af Sandimmun
English: Due to the variability of this condition, treatment must be individualised.
Danish: Behandling af denne tilstand skal tilpasses individuelt, da sygdommen varierer meget.
English: Sandimmun concentrate for solution for infusion contains macrogolglycerol ricinoleate/polyethoxylated castor oil, which can cause phathalate stripping from polyvinyl chloride.
Danish: Sandimmun koncentrat til infusionsvæske indeholder polyoxyleret ricinusolie (macrogolglycerol ricinoleat), som kan forårsage phthalat-stripping fra PVC.
English: Sandimmun and associated names (see Annex I) 50 mg/ml concentrate for solution for infusion [See Annex I - To be completed nationally]
Danish: Sandimmun og relaterede navne (se Bilag I) 50 mg/ml koncentrat til infusionsvæske, opløsning [Se bilag I - Udfyldes nationalt]
English: Rifampicin induces ciclosporin intestinal and liver metabolism.
Danish: Rfampicin inducerer metaboliseringen af ciclosporin i tarm og lever.
English: • Feeling numb or tingling.
Danish: • Følelsesløshed eller snurrende fornemmelse.
English: • High blood pressure.
Danish: • Forhøjet blodtryk.
English: • Tell your doctor if you are breast-feeding.
Danish: • Fortæl det til lægen, hvis du ammer.
English: Ciclosporin is an inhibitor of CYP3A4, the multidrug efflux transporter P-glycoprotein (P-gp) and organic anion transporter proteins (OATP).
Danish: Ciclosporin hæmmer CYP3A4, multilægemiddel-effluks-transporter P-glykoprotein (P-gp) og organisk aniontransporter-proteiner (OATP).
English: There is a high variability in the data reported on the terminal elimination half-life of ciclosporin, depending on the assay applied and the target population.
Danish: Der er stor variation i de foreliggende data om ciclosporins terminale halveringstid alt efter den anvendte analyse og målpopulationen.
English: Patients on Sandimmun should not receive concomitant ultraviolet B irradiation or PUVA photochemotherapy.
Danish: Patienter, der behandles med Sandimmun, bør ikke samtidig få behandling med UV-B-bestråling eller PUVA-fotokemoterapi.
English: Sandimmun 50 mg soft capsules are corn yellow and oblong.
Danish: Sandimmun 50 mg bløde kapsler er korngule og aflange.
English: EXPIRY DATE [To be completed nationally]
Danish: UDLØBSDATO [Udfyldes nationalt]
English: In nephrotic syndrome patients with impaired renal function, the initial dose should not exceed 2.5 mg/kg/day.
Danish: Hos patienter med nefrotisk syndrom, som har nedsat nyrefunktion, bør initialdosis ikke overstige 2,5 mg/kg/dag.
English: Very common side effects: These side effects may affect more than 1 in 10 people.
Danish: Meget almindelige bivirkninger: Disse bivirkninger kan forekomme hos flere end 1 ud af 10 personer.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION [To be completed nationally]
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN