FrancophonIA/ELRC3.0 huggingface dataset:
English: Limited data suggest there is no clinically significant effect on valproic acid pharmacokinetics.
Danish: Begrænsede data antyder, at der ikke er klinisk signifikant effekt på valproinsyres farmakokinetik.
English: If you are taking any of these medicines, tell your doctor immediately.
Danish: Hvis De tager et eller flere af disse lægemidler, skal De straks fortælle det til lægen.
English: ZDV + 3TC
Danish: EFV + ZDV + 3TC
English: In patients treated with other medicinal products associated with liver toxicity, monitoring of liver enzymes is also recommended.
Danish: Hos patienter, der er behandlet med andre lægemidler, der sættes i forbindelse med levertoksicitet, anbefales monitorering af leverenzymer.
English: Although in vitro data suggest that efavirenz inhibits CYP2C9 and CYP2C19, there have been contradictory reports of both increased and decreased exposures to substrates of these enzymes when coadministered with efavirenz in vivo.
Danish: Selvom in vitro data antyder, at efavirenz hæmmer CYP2C9 og CYP2C19, har der været modstridende rapporter om både øget og nedsat eksponering for substrater af disse enzymer ved samtidig administration af efavirenz in vivo.
English: Efavirenz intact hard capsules must only be administered to children who are able to reliably swallow hard capsules.
Danish: Intakte hårde Efavirenz-kapsler må kun gives til børn, som er i stand til at sluge hårde kapsler.
English: Because of the extensive cytochrome P450-mediated metabolism of efavirenz and limited clinical experience in patients with chronic liver disease, caution must be exercised in administering efavirenz to patients with mild hepatic impairment.
Danish: På grund af den omfattende cytokrom P450-medierede metabolisering af efavirenz og den begrænsede kliniske erfaring hos patienter med kronisk leverlidelse, skal der udvises forsigtighed ved administration af efavirenz til patienter med mild leverinsufficiens.
English: There have been seven retrospective reports of findings consistent with neural tube defects, including meningomyelocele, all in mothers exposed to efavirenz-containing regimens (excluding any efavirenzcontaining fixed-dose combination tablets) in the first trimester.
Danish: Der har været 7 retrospektive rapporter om fund svarende til neuralrørsdefekter, herunder meningomyelocele, alle hos mødre, der i første trimester havde været eksponeret for efavirenzholdige regimer (eksklusive efavirenzholdige kombinationstabletter i faste doser).
English: Study 020 enrolled 327 patients who had been treated with NRTIs but not with PIs or NNRTIs.
Danish: Undersøgelse 020 omfattede 327 patienter som havde fået NRTI behandling men ikke PI eller NNRTI behandling.
English: Laboratory tests should be performed to evaluate their liver disease at periodic intervals (see section 4.2).
Danish: Der bør med jævne mellemrum udføres laboratorieundersøgelser med henblik på vurdering af deres leversygdom (se pkt.
English: These problems tend to occur more often in those who have a history of mental illness.
Danish: Det ser ud som om disse problemer oftere opstår hos patienter, der i forvejen lider af en psykisk sygdom.
English: For children who are not able to swallow the capsules, the doctor may recommend opening the hard capsule and mixing the contents with a small amount (1-2 teaspoons) of food (e.g., yogurt ).
Danish: Til børn, der ikke er i stand til at sluge kapslerne kan lægen anbefale at man åbner den hårde kapsel og blander indholdet med en lille mængde (1 - 2 tsk.)
English: K103N was the most frequently observed RT substitution in viral isolates from patients who experienced a significant rebound in viral load during clinical studies of efavirenz in combination with indinavir or zidovudine + lamivudine.
Danish: K103N var den hyppigst sete RT-substitution i virale isolater fra patienter, som oplevede markant reboundfænomen af virus i blodet i løbet af kliniske undersøgelser af efavirenz i kombination med indinavir eller zidovudin + lamivudin.
English: A similar reduction in indinavir exposures was observed when indinavir 1000 mg q8h was given with efavirenz 600 mg daily.
Danish: Der sås en lignende reduktion i indinavireksponering, når indinavir 1.000 mg q8h blev givet sammen med efavirenz 600 mg dagligt.
English: Symptoms including, but not limited to, dizziness, insomnia, somnolence, impaired concentration and abnormal dreaming are frequently reported adverse reactions in patients receiving efavirenz 600 mg daily in clinical studies (see section 4.8).
Danish: Symptomer, der inkluderer, men ikke er begrænsede til, svimmelhed, søvnløshed, søvnighed, nedsat koncentrationsevne og abnorme drømme er hyppigt indberettede uønskede reaktioner hos patienter i kliniske undersøgelser i behandling med efavirenz 600 mg dagligt (se pkt.
English: Appropriate antihistamines and/or corticosteroids may improve the tolerability and hasten the resolution of rash.
Danish: Relevante antihistaminer og/eller kortikosteroider kan forbedre tolerabiliteten og fremskynde udslættets forsvinden.
English: Medicines used to treat malaria: artemether/lumefantrine: SUSTIVA may reduce the amount of artemether/lumefantrine in your blood.
Danish: Medicin til behandling af malaria: artemether/lumefantrin: SUSTIVA kan nedsætte mængden af artemether/lumefantrin i blodet.
English: In uninfected volunteers, multiple doses of 200 - 400 mg per day for 10 days resulted in a lower than predicted extent of accumulation (22 - 42% lower) and a shorter terminal half-life compared with single dose administration (see below).
Danish: Hos ikke-inficerede frivillige resulterede multiple doser på 200 - 400 mg per dag i 10 dage i en lavere grad af akkumulation (2242% lavere) end forudset samt kortere halveringstid sammenlignet med enkeltdosisadministration (se nedenfor).
English: Two additional cases (1 prospective and 1 retrospective) including events consistent with neural tube defects have been reported with the fixed-dose combination tablet containing efavirenz, emtricitabine, and tenofovir disoproxil fumarate.
Danish: Der er rapporteret om yderligere to tilfælde (1 prospektivt og 1 retrospektivt), herunder hændelser svarende til neuralrørsdefekter, med fastdosis-kombinationstabletten indeholdende efavirenz, emtricitabin og tenofovirdisoproxilfumarat.
English: If you notice any symptoms of infection, please tell your doctor immediately.
Danish: Hvis De bemærker symptomer på infektion, skal De omgående fortælle det til Deres læge.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION SUSTIVA 50 mg hard capsules
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING SUSTIVA 50 mg hårde kapsler
English: METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use.
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Læs indlægssedlen før brug.
English: Tests may show: increased cholesterol in the blood
Danish: Laboratorieundersøgelser kan vise: Forhøjet indhold af kolesterol i blodet
English: No dose adjustment is necessary for any of these medicinal products.
Danish: Dosisjustering er ikke nødvendig for disse lægemidler.
English: SUSTIVA is indicated in antiviral combination treatment of human immunodeficiency virus-1 (HIV1) infected adults, adolescents and children 3 months of age and older and weighing at least 3.5 kg.
Danish: SUSTIVA er indiceret til antiviral kombinationsbehandling af humant immundefektvirus-1 (hiv-1) inficerede voksne, unge og børn fra 3 måneder og opefter, som vejer mindst 3,5 kg.
English: If efavirenz and telaprevir are co-administered, telaprevir 1,125 mg every 8 hours should be used.
Danish: Hvis efavirenz og telaprevir administreres samtidigt, skal der gives telaprevir 1,125 mg hver 8. time.
English: Some patients taking combination antiretroviral therapy may develop a bone disease called osteonecrosis (death of bone tissue caused by loss of blood supply to the bone).
Danish: Nogle af de patienter, der får antiretroviral kombinationsbehandling, kan udvikle en knoglesygdom, der kaldes knoglenekrose (hvor knoglevævet dør på grund af nedsat blodtilførsel til knoglen).
English: Mean AUC(0-24) µM·h
Danish: Gennemsnitlig AUC(0-24) µM·t
English: The child should not be given any additional food for 2 hours.
Danish: Barnet bør ikke få ekstra føde de næste to timer.
English: The incidence of erythema multiforme or Stevens-Johnson syndrome was approximately 0.1%.
Danish: Incidensen af erythema multiforme eller Stevens-Johnsons syndrom var ca. 0,1%.
English: Phenytoin, Phenobarbital, and other anticonvulsants that are substrates of CYP450 isoenzymes
Danish: Phenytoin, phenobarbital og andre antikonvulsiva, som er substrater for CYP-isoenzymer
English: In case of concomitant antiviral therapy for hepatitis B or C, please refer also to the relevant product information for these medicinal products.
Danish: Ved samtidig antiviral behandling af Hepatitis B eller C, henvises til det pågældende produktresumé.
English: No dose adjustment is necessary for rifampicin, including 600 mg.
Danish: Dosisjustering er ikke nødvendig for rifampicin, inklusive 600 mg.
English: Individual tolerability and virological response should be considered when making the dose adjustment (see section 5.2).
Danish: Der skal tages hensyn til individuel tolerans og virologisk respons, når dosis justeres (se pkt.
English: In HIV-1 infected patients (n = 6), the pharmacokinetics of indinavir and efavirenz were generally comparable to these uninfected volunteer data.
Danish: Hos hiv-1-inficerede patienter (n = 6) var indinavirs og efavirenz' farmakokinetik generelt sammenlignelig med data fra ikke-inficerede frivillige.
English: The clinical outcome of this observed reduction of boceprevir trough concentrations has not been directly assessed.
Danish: Den kliniske konsekvens af denne reduktion i boceprevirs dalplasmakoncentration er ikke blevet vurderet direkte.
English: Sufficient data on the tolerability of efavirenz with lowdose ritonavir (100 mg, once or twice daily) are not available.
Danish: Tilstrækkelige data vedrørende tolerans af efavirenz sammen med ritonavir 100 mg i lav dosis (én eller to gange dagligt) er ikke tilgængelige.
English: Severe rash associated with blistering, moist desquamation or ulceration has been reported in less than 1% of patients treated with efavirenz.
Danish: Der er rapportert svært udslæt, ledsaget af blæredannelse, fugtig afskalning eller ulceration hos færre end 1% af de patienter, der er behandlet med efavirenz.
English: Carcinogenicity studies showed an increased incidence of hepatic and pulmonary tumours in female mice, but not in male mice.
Danish: Carcinogenecitetsundersøgelser har vist øget incidens af hepatiske og pulmonære tumorer hos hunmus, men ikke hos hanmus.
English: Efavirenz in combination with darunavir/ritonavir 800/100 mg once daily may result in suboptimal darunavir Cmin.
Danish: Efavirenz i kombination med darunavir/ritonavir 800/100 mg én gang dagligt kan resultere i suboptimal darunavir Cmin.
English: How to take SUSTIVA 4.
Danish: Sådan skal De tage SUSTIVA 4.
English: The frequency category of "rare" was defined per A Guideline on Summary of Product Characteristics (SmPC) (rev. 2, Sept 2009) on the basis of an estimated upper bound of the 95% confidence interval for 0 events given the number of patients treated with efavirenz in these clinical trials (n=3,969).
Danish: Hyppigheden "sjælden" blev defineret i henhold til vejledningen "A Guideline on Summary of Product Characteristics (SmPC)" (rev. 2. september 2009) på basis af en estimeret øvre grænse for 95% konfidensintervallet for 0 hændelser på baggrund af det antal forsøgspersoner, der blev behandlet med efavirenz i disse kliniske undersøgelser (n=3.969).
English: The dose for adults is 600 mg once daily.
Danish: Dosis til voksne er 600 mg 1 gang dagligt.
English: The in vitro studies suggest that CYP3A4 and CYP2B6 are the major isozymes responsible for efavirenz metabolism and that it inhibited P450 isozymes 2C9, 2C19, and 3A4.
Danish: In vitro-undersøgelserne tyder på, at CYP3A4 og CYP2B6 er de isoenzymer, der hovedsageligt er ansvarlige for efavirenz-metaboliseringen, og at det hæmmede P450 isoenzymerne 2C9, 2C19 og 3A4.
English: Cmax: ↔ 11% (CYP3A induction - effect on boceprevir) *0-8 hours
Danish: Cmax: ↔ 11% (CYP3A-induktion - indvirkning på boceprevir) *0-8 timer
English: Your doctor may consider changing your dose or giving you an alternative antibiotic.
Danish: Lægen kan overveje at ændre dosis eller at give Dem et andet antibiotisk lægemiddel.
English: In both studies, plasma progesterone levels for subjects receiving efavirenz and DMPA remained low consistent with suppression of ovulation.
Danish: I begge undersøgelser forblev progesteronkoncentrationen i plasma lav hos de forsøgspersoner, der fik efavirenz og DMPA, forenelig med suppression af ovulationen.
English: 6 With your hands over the container, hold the capsule with the cap facing up (see illustration b).
Danish: 6 Hold hænderne over skålen og hold kapslen med toppen opad (se illustration b).
English: Decreased exposure of the immunosuppressant may be expected (CYP3A4 induction).
Danish: Nedsat eksponering af det immunsuppressive lægemiddel kan forventes (CYP3A4induktion).
English: Each carton contains 1 bottle of 30 filmcoated tablets.
Danish: Hver æske indeholder 1 flaske med 30 filmovertrukne tabletter.
English: SUSTIVA, which contains the active substance efavirenz, belongs to a class of antiretroviral medicines called non-nucleoside reverse transcriptase inhibitors (NNRTIs).
Danish: SUSTIVA, der indeholder den aktive substans efavirenz, hører til den antiretrovirale medicingruppe, som kaldes non-nukleoside reverse transkriptasehæmmere (NNRTI'ere).
English: SUSTIVA must always be taken in combination with other anti-HIV medicines.
Danish: SUSTIVA skal altid tages sammen med andre anti-hiv-lægemidler.
English: General disorders and administration site conditions common
Danish: Almene symptomer og reaktioner på administrationsstedet Almindelig
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucosegalactose malabsorption should not take this medicinal product.
Danish: Patienter med sjældne, arvelige sygdomme som galactoseintolerance, en særlig for for lactasemangel (Lapp Lactase deficiency) eller glucose/galactosemalabsorption bør ikke tage dette lægemiddel.
English: Theoretically, efavirenz may therefore initially increase the exposure to CYP3A4 substrates and caution is warranted for CYP3A4 substrates with narrow therapeutic index (see section 4.3).
Danish: Teoretisk kan efavirenz derfor i begyndelsen øge eksponeringen for CYP3A4-substrater, og forsigtighed er påkrævet ved samtidig administration af CYP3A4-substrater med et snævert terapeutisk indeks (se pkt.
English: The recommended dose of efavirenz in combination with a PI and/or NRTIs for patients between 3 months and 17 years of age is described in Table 1.
Danish: Den anbefalede dosis af efavirenz i kombination med en PI (proteasehæmmer) og/eller NRTI'er (nukleosid revers transkriptasehæmmere) for patienter på mellem 3 måneder og 17 år er beskrevet i Tabel 1.
English: IMMUNOSUPPRESSANTS Immunosuppressants metabolized by CYP3A4 (eg, cyclosporine, tacrolimus, sirolimus)/Efavirenz
Danish: IMMUNSUPPRESSIVA Immunsuppressiva metaboliseres via CYP3A4 (fx ciclosporin, tacrolimus, sirolimus)/efavirenz
English: Efavirenz exposure may be increased when given with medicinal products (for example, ritonavir) or food (for example, grapefruit juice), which inhibit CYP3A4 or CYP2B6 activity.
Danish: Efavirenzeksponeringen kan være øget, når det gives sammen med lægemidler (fx ritonavir) eller føde (fx grapefrugtjuice), som hæmmer CYP3A4- eller CYP2B6-aktivitet.
English: Two controlled studies (006 and ACTG 364) of approximately one year duration with efavirenz in combination with NRTIs and/or PIs, have demonstrated reduction of viral load below the limit of quantification of the assay and increased CD4 lymphocytes in antiretroviral therapy-naïve and NRTIexperienced HIV-infected patients.
Danish: To kontrollerede undersøgelser (006 og ACTG 364) af ca. 1 års varighed med efavirenz i kombination med NRTI´ere og/eller PI´ere har vist en reduktion i mængden af virus i blodet til under detektionsgrænsen i assayet og stigning i CD4 lymfocytter hos antiretroviral behandlingsnaive og NRTI-behandlede hiv-inficerede patienter.
English: Efavirenz has been shown to induce CYP3A4 and CYP2B6, resulting in the induction of its own metabolism, which may be clinically relevant in some patients.
Danish: Det er påvist, at efavirenz inducerer CYP3A4 og CYP2B6, hvilket medfører induktion af dets egen metabolisering, hvilket kan være klinisk relevant hos nogle patienter.
English: EFV + NFV + NRTIs 65 70 (59, 82) EFV + NRTIs
Danish: EFV + NFV + NRTI´ere 65 70 (59, 82) EFV + NRTI´ere
English: Packs of 42 x 1 hard capsules in aluminium/PVC perforated unit dose blisters.
Danish: Pakninger med 42 x 1 hårde kapsler i aluminium/PVC perforeret enkeltdosis blister.
English: If you stop taking SUSTIVA
Danish: Hvis De holder op med at tage SUSTIVA
English: 10 Mix the capsule contents and food together (illustration e).
Danish: 10 Bland kapslens indhold med maden (illustration e).
English: Diltiazem or similar medicines (called calcium channel blockers which are medicines typically used for high blood pressure or heart problems): when you start taking SUSTIVA, your doctor may need to adjust your dose of the calcium channel blocker.
Danish: Diltiazem eller lignende medicin (kaldet calciumantagonister, som er lægemidler, der typisk anvendes til behandling af højt blodtryk eller hjerteproblemer): når De starter med at tage SUSTIVA, kan lægen være nødt til at justere dosis af en calciumantagonist.
English: a 90% confidence intervals unless otherwise noted.
Danish: 90% konfidensinterval med mindre andet er angivet.
English: Table 2: Efficacy results for study 006 Responder rates (NC = Fa) Plasma HIV-RNA
Danish: Tabel 2: Effektresultat for undersøgelse 006 Respons hyppigheder (NC = Fa) Plasma hiv-RNA
English: SUSTIVA may reduce the amount of voriconazole in your blood and voriconazole may increase the amount of SUSTIVA in your blood.
Danish: SUSTIVA kan mindske mængden af voriconazol i blodet, og voriconazol kan øge mængden af SUSTIVA i blodet.
English: Cross resistance profiles for efavirenz, nevirapine and delavirdine in cell culture demonstrated that the K103N substitution confers loss of susceptibility to all three NNRTIs.
Danish: Ved cellekultur viste krydsresistensprofiler for efavirenz, nevirapin og delavirdin, at K103Nsubstitutionen giver tab af følsomhed over for alle tre NNRTI´ere.
English: The dose of nelfinavir was 750 mg given three times a day.
Danish: Nelfinavirdosis var 750 mg 3 gange dagligt.
English: Isolated elevations of GGT in patients receiving efavirenz may reflect enzyme induction.
Danish: Isolerede forhøjelser af GGT hos patienter, som får efavirenz, kan give enzyminduktion.
English: Study 020
Danish: Undersøgelse 020 24 uger
English: Medicines used to treat infection with the hepatitis C virus: boceprevir, telaprevir, elbasvir/grazoprevir, simeprevir, sofosbuvir/velpatasvir, sofosbuvir/velpatasvir/voxilaprevir, glecaprevir/pibrentasvir.
Danish: Medicin til behandling af infektion med hepatitis C-virus: boceprevir, telaprevir, elbasvir/grazoprevir, simeprevir, sofosbuvir/velpatasvir, sofosbuvir/velpatasvir/voxilaprevir, glecaprevir/pibrentasvir.
English: Efavirenz must be discontinued in patients developing severe rash associated with blistering, desquamation, mucosal involvement or fever.
Danish: Efavirenz skal seponeres hos patienter, der udvikler svært udslæt ledsaget af blæredannelse, afskalning, mucosapåvirkning eller feber.
English: Efavirenz has also been shown to induce UGT1A1.
Danish: Det er også påvist, at efavirenz inducerer UGT1A1.
English: Nervous system disorders common cerebellar coordination and balance disturbances†, disturbance in attention (3.6%), dizziness (8.5%), headache (5.7%), somnolence (2.0%)*
Danish: Cerebellar koordinations- og balanceforstyrrelse‡, opmærksomhedsforstyrrelse (3,6%), svimmelhed (8,5%), hovedpine (5,7%), døsighed (2,0%)*
English: It is recommended that the tablet be swallowed whole with water.
Danish: Det anbefales, at tabletten sluges hel sammen med postevand.
English: Implant: Etonogestrel/Efavirenz Decreased exposure of etonogestrel may be expected (CYP3A4 induction).
Danish: Implantat: Etonogestrel/efavirenz Der kan forventes nedsat eksponering for etonogestrel (CYP3A4-induktion).
English: Pharmacotherapeutic group: Antivirals for systemic use, non-nucleoside reverse transcriptase inhibitors.
Danish: Farmakoterapeutisk klassifikation: Antivirale til systemisk anvendelse, non-nukleoside reverse transkriptasehæmmere.
English: posaconazole.
Danish: posaconazol.
English: * When compared to atazanavir 300 mg/ritonavir 100 mg once daily in the evening without efavirenz.
Danish: * Ved sammenligning med atazanavir 300 mg/ritonavir 100 mg én gang dagligt om aftenen uden efavirenz.
English: The incidence of erythema multiforme or StevensJohnson syndrome was approximately 0.1%.
Danish: Incidensen af erythema multiforme eller Stevens- Johnsons syndrom var ca. 0,1%.
English: In most patients rash resolves with continuing therapy with efavirenz within one month.
Danish: Hos de fleste patienter forsvinder udslættet inden for 1 måned ved fortsat behandling med efavirenz.
English: If efavirenz is to be used in combination with darunavir/ritonavir, the darunavir/ritonavir 600/100 mg twice daily regimen should be used.
Danish: Hvis efavirenz skal bruges i kombination med darunavir/ritonavir, bør darunavir/ritonavir-regime på 600/100 mg to gange dagligt anvendes.
English: (CYP3A4 induction) Efavirenz:
Danish: (CYP3A4-induktion) Efavirenz:
English: SUSTIVA is not recommeded for children under the age of 3 months or weighing less than 3.5 kg because it has not been adequately studied in these patients.
Danish: SUSTIVA anbefales ikke til børn under 3 måneder, eller som vejer under 3,5 kg, da det ikke er tilstrækkeligt undersøgt hos disse patienter.
English: Viral isolates recovered from PBMCs of patients enrolled in efavirenz clinical studies who showed evidence of treatment failure (viral load rebound) were assessed for susceptibility to NNRTIs.
Danish: Virale isolater, der er indhentet fra PBMCer fra patienter, der var inkluderet i kliniske efavirenzundersøgelser, som viste tegn på behandlingssvigt (reboundfænomen af virus i blodet) blev vurderet med henblik på følsomhed over for NNRTI´ere.
English: Since fluoxetine shares a similar metabolic profile with paroxetine, i.e. a strong CYP2D6 inhibitory effect, a similar lack of interaction would be expected for fluoxetine.
Danish: Da fluoxetin har samme metaboliske profil som paroxetin, dvs. stærk CYP2D6-hæmmende virkning, forventes samme mangel på interaktion for fluoxetin.
English: It is recommended that the capsule be swallowed whole with water.
Danish: Det anbefales, at kapslen sluges hel sammen med postevand.
English: If therapy with efavirenz is discontinued, consideration should also be given to interrupting therapy with other antiretroviral agents to avoid development of resistant virus (see section 4.8).
Danish: Hvis behandlingen med efavirenz seponeres, skal det også overvejes at afbryde behandlingen med andre antiretrovirale lægemidler for at undgå udvikling af resistent virus (se pkt.
English: In in vitro studies efavirenz did not inhibit CYP2E1 and inhibited CYP2D6 and CYP1A2 only at concentrations well above those achieved clinically.
Danish: I in vitro-undersøgelser hæmmede efavirenz ikke CYP2E1og hæmmede kun CYP2D6 og CYP1A2 ved koncentrationer, der lå langt over de klinisk opnåede.
English: Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Danish: En opdateret RMP skal fremsendes: på anmodning fra Det Europæiske Lægemiddelagentur når risikostyringssystemet ændres, særlig som følge af, at der er modtaget nye oplysninger, der kan medføre en væsentlig ændring i risk/benefit-forholdet, eller som følge af, at en vigtig milepæl (lægemiddelovervågning eller risikominimering) er nået.