FrancophonIA/ELRC3.0 huggingface dataset:
English: Invirase/ritonavir may increase concentrations of tricyclic antidepressants.
Danish: Invirase/ritonavir kan øge koncentrationen af tricykliske antidepressiva.
English: In a myocardial distribution study in the rat an approximately 2-fold accumulation of saquinavir was observed in the heart compared to plasma after coadministration of saquinavir and ritonavir.
Danish: I et studie over myokardiel fordeling hos rotter blev der observeret en 2-fold større akkumulering af saquinavir i hjertet sammenlignet med plasma efter samtidig administration af saquinavir og ritonavir.
English: Initiated assigned treatment, n (%)
Danish: Påbegyndt tildelt behandling, n (%)
English: Patients should also be advised that they might experience undesirable effects associated with coadministered medications.
Danish: Patienterne bør også rådgives om, at de kan få bivirkninger i forbindelse med samtidigt administrerede lægemidler.
English: Dose of maraviroc should be decreased to 150 mg bid with monitoring.
Danish: Maravirocdosis bør nedsættes til 150 mg 2 gange daglig under monitorering.
English: • some medicines affecting the immune system - such as ciclosporin, sirolimus (rapamycin),
Danish: • nogle lægemidler som påvirker immunsystemet - såsom ciclosporin, sirolimus (rapamycin),
English: Invirase contains lactose
Danish: Invirase indeholder lactose
English: Your doctor will prescribe Invirase in combination with ritonavir (Norvir) and other HIV medicines.
Danish: Din læge vil ordinere Invirase i kombination med ritonavir (Norvir) og andre lægemidler mod hiv.
English: If you forget to take Invirase
Danish: Hvis du har glemt at tage Invirase
English: (90% CI 109%-162%) Rifabutin active moiety*
Danish: (90 % konfidensinterval: 109 %-162 %) Rifabutin aktiv del*
English: Therefore, when saquinavir is co-administered with ritonavir, consideration should be given to the potential effects of ritonavir on other medicinal products (see the Summary of Product Characteristics for Norvir).
Danish: Hvis saquinavir derfor gives sammen med ritonavir, skal de potentielle virkninger af ritonavir på andre lægemidler tages i betragtning (se produktresumeet for Norvir).
English: No dose adjustment required when saquinavir/ritonavir combined with ≤ 200 mg/day ketoconazole.
Danish: Dosisjustering er ikke nødvendig, når saquinavir/ritonavir kombineres med ≤ 200 mg ketoconazol/dag.
English: Saquinavir AUC ↓ 24% Nevirapine AUC ↔
Danish: - Saquinavir AUC ↓ 24 % Nevirapin AUC ↔
English: Proportion with VL < 50 copies/ml at week 48, ITT/e#
Danish: Andel med VL < 50 kopier/ml ved uge 48, ITT/e#
English: Absolute bioavailability averaged 4 % (CV 73 %, range: 1 % to 9 %) in 8 healthy volunteers who received a single 600 mg dose (3 x 200 mg hard capsule) of Invirase following a heavy breakfast.
Danish: Absolut biotilgængelighed var i gennemsnit 4 % (CV 73 %, range: 1 % til 9 %) hos 8 raske frivillige der fik en enkelt 600 mg dose (3 x 200 mg hårde kapsler) Invirase efter et stort morgenmåltid.
English: Increased blood bilirubin, increased blood amylase
Danish: Forhøjet bilirubin, forhøjet amylase
English: • Contact your doctor immediately, if you get palpitations or an irregular heart beat during treatment.
Danish: • Kontakt omgående din læge, hvis du får hjertebanken eller uregelmæssig hjerterytme
English: Saquinavir inhibited both hERG current and L-type Ca++ channel current with respective IC50s of 4.7 and 6.3 μM.
Danish: Saquinavir hæmmede både hERG-strøm og L-type Ca++kanalstrøm med en IC50 på henholdsvis 4,7 µM og 6,3 µM.
English: Saquinavir Cmin ↓ 78% Dual-boosted protease inhibitor combination therapy in multipletreatment experienced HIV-positive adults.
Danish: Saquinavir Cmin ↓ 78 % Dobbeltboostet kombinationsbehandling med proteasehæmmer hos multibehandlede hiv-positive voksne.
English: The clinical relevance of these findings from this study in healthy volunteers to the use of Invirase/ritonavir in HIV-infected patients is unclear, but doses exceeding Invirase/ritonavir 1000/100 mg twice daily should be avoided.
Danish: Den kliniske relevans af disse resultater i dette studie med raske frivillige i forhold til anvendelsen af Invirase/ritonavir hos hiv-inficerede patienter er uklar, men doser, som overstiger Invirase/ritonavir 1.000/100 mg 2 gange daglig, bør undgås.
English: The clinical relevance of these preclinical results are unknown, however cardiac conduction and repolarisation abnormalities in humans have been observed with saquinavir and ritonavir combination therapy (see section 4.4 and 5.1).
Danish: Den kliniske relevans af disse prækliniske resultater er ikke kendt, men kardielle lednings- og repolariseringsabnormiteter hos mennesker er blevet observeret ved kombinationsbehandling med saquinavir og ritonavir (se pkt.4.4 og 5.1).
English: Co-administration of saquinavir and ritonavir has led to severe adverse events, mainly diabetic ketoacidosis and liver disorders, especially in patients with preexisting liver disease.
Danish: Samtidig administration af saquinavir og ritonavir har medført svære bivirkninger, hovedsagelig diabetisk ketoacidose og leverpåvirkninger, især hos patienter med præeksisterende leverlidelse.
English: • a salt imbalance in your blood, especially low blood concentrations of potassium (hypokalaemia),
Danish: • hvis du har forstyrrelser i saltbalancen i blodet, især lavt kaliumindhold i blodet (hypokaliæmi),
English: Continuous declines in HIV-RNA were observed in all treatment-naïve patients receiving the modified Invirase/ritonavir dosing regimen over the 2-week treatment period, suggesting HIV viral suppression during the time of the study.
Danish: Vedvarende fald i hiv-RNA blev observeret hos alle behandlingsnaive patienter, der modtog det modificerede Invirase/ritonavir-dosisregime over behandlingsperioden på 2 uger, hvilket tyder på hiv viral suppression under forsøgsperioden.
English: Terfenadine AUC ↑, associated with a prolongation of QTc intervals.
Danish: Terfenadin AUC ↑, ledsaget af en forlængelse af QTc-intervaller.
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 behandling med antiretroviral behandling for hepatitis B eller C, henvises også til produktresuméerne for disse produkter.
English: • Clinical Management:
Danish: • Klinisk håndtering
English: Low dose ritonavir increases the concentration of indinavir.
Danish: - Administration af lav dosis ritonavir øger koncentrationen af indinavir.
English: UNIQUE IDENTIFIER - 2D BARCODE <2D barcode carrying the unique identifier included.>
Danish: ENTYDIG IDENTIFIKATOR - 2D -STREGKODE Der er anført en 2D-stregkode, som indeholder en entydig identifikator.
English: In a clinical study 11 of 17 (65 %) healthy volunteers developed severe hepatocellular toxicity with transaminase elevations up to > 20fold the upper limit of normal after 1 to 5 days of co-administration.
Danish: I et klinisk studie udviklede 11 ud af 17 (65 %) raske frivillige alvorlig hepatocellulær toksicitet med stigninger i transaminase på op til > 20 gange den øvre normalgrænse efter 1 til 5 dages co-administration.
English: Increased plasma concentrations of quetiapine may lead to coma (see sectin 4.3).
Danish: Øgede quetiapinplasmakoncentrationer kan føre til koma (se pkt.
English: Steady state saquinavir exposures observed in paediatric trials were substantially higher than historical data in adults where dose- and exposure-dependent QTc and PR prolongation were observed (see section 4.4).
Danish: Eksponeringen for saqunavir ved steady state observeret i pædiatriske studier var væsentligt højere end historiske data hos voksne, hvor dosis- og eksponerings-afhængig QTc- og PR-forlængelse blev observeret (se pkt.
English: When used with Invirase/ritonavir, the lowest possible dose of atorvastatin should be administered and the patient should be carefully monitored for signs/symptoms of myopathy (muscle weakness, muscle pain, rising plasma creatinine kinase, see section 4.4).
Danish: Når det anvendes sammen med Invirase/ritonavir, skal der administreres den lavest mulige atorvastatindosis, og patienterne bør kontrolleres omhyggeligt for tegn/symptomer på myopati (muskelslaphed, muskelsmerter, stigende plasmakreatininkinase) (se pkt.
English: Other potential interactions Medicinal products that are substrates of CYP3A4 e.g. dapsone, disopyramide, quinine, fentanyl, and alfentanyl
Danish: Andre potentielle interaktioner Lægemidler som er substrater for CYP3A4 F.eks. dapson, disopyramid, quinin, fentanyl og alfentanyl
English: Blood and the lymphatic system disorders Very common
Danish: Blod og lymfesystem Meget almindelig
English: Combination not recommended.
Danish: Kombinationen anbefales ikke.
English: • medicines to treat depression - such as nefazodone, tricyclic antidepressants
Danish: • lægemidler til behandling af depression - såsom nefazodon, tricykliske antidepressiva
English: The inducing effect of St. John's wort may persist for at least 2 weeks after cessation of treatment.
Danish: Den inducerende effekt af perikon kan vedvare i mindst 2 uger efter ophør af behandling.
English: Other conditions
Danish: Andre tilstande
English: Infection: In some patients with advanced HIV infection (AIDS) and a history of opportunistic infection, signs and symptoms of inflammation from previous infections may occur soon after antiHIV treatment is started.
Danish: Infektion: Hos nogle patienter med fremskreden hiv-infektion (aids), som tidligere har haft opportunistisk infektion, kan tegn og symptomer på betændelse fra tidligere infektioner forekomme kort efter, at anti-hiv-behandlingen er startet.
English: Long-acting beta2-adrenergic agonist Salmeterol
Danish: Langtidsvirkende beta2-adrenerg agonist Salmeterol
English: The absolute bioavailability of saquinavir co-administered with ritonavir has not been established in humans.
Danish: Den absolutte biotilgængelighed af saquinavir administreret samtidig med ritonavir er ikke blevet bestemt hos mennesker.
English: • medicines used to treat high blood pressure in the arteries of the lungs (a disease known as pulmonary arterial hypertension) such as bosentan.
Danish: • lægemidler til behandling af højt blodtryk i lungernes blodårer (en sygdom kendt som pulmonal arterial hypertension) - såsom bosentan
English: Invirase with food and drink Invirase must be taken together with ritonavir and with or after food.
Danish: Brug af Invirase sammen med mad og drikke Invirase skal tages sammen med ritonavir, og med eller efter et måltid.
English: Proportion with VL < 50 copies/ml at week 48, On Treatment
Danish: Andel med VL < 50 kopier/ml ved uge 48, i behandling
English: Change in Baseline Plasma HIV-1 RNA at Weeks 12-20
Danish: Ændring i baselineplasma hiv-1-RNA efter uger 12-20
English: • medicines for anticoagulation - warfarin
Danish: • blodfortyndende medicin - warfarin
English: Lactose (monohydrate), Magnesium stearate.
Danish: Lactose (monohydrat) Magnesiumstearat
English: Observations from drug interaction studies done with unboosted saquinavir might not be representative of the effects seen with saquinavir/ritonavir therapy.
Danish: Observationerne fra lægemiddelinteraktionsstudierne med ikke-boostet saquinavir er ikke repræsentative for de virkninger som ses med saquinavir/ritonavir-behandling.
English: • medicines for other severe mental health problems - such as clozapine, haloperidol,
Danish: • lægemidler til behandling af andre alvorlige mentale forstyrrelser - såsom clozapin, haloperidol,
English: • congenital or documented acquired QT prolongation
Danish: • medfødt eller dokumenteret erhvervet QT-forlængelse
English: There were no clinically significant differences in the pharmacokinetic profile of ritonavir in fasting and fed conditions but the ritonavir Ctrough (geometric mean 245 vs. 348 ng/ml) was lower in the fasting state compared to the administration with a meal.
Danish: Der var ingen klinisk signifikante forskelle i den farmakokinetiske profil af ritonavir i fastende eller mæt tilstand, men ritonavir Ctrough (geometrisk gennemsnit 245 mod 348 ng/ml) var lavere under fastende betingelser end efter indtagelse af et måltid.
English: Patients with pre-existing liver dysfunction including chronic active hepatitis have an increased frequency of liver function abnormalities during combination antiretroviral therapy and should be monitored according to standard practice.
Danish: Patienter med allerede kendt leverdysfunktion, inklusiv kronisk aktiv hepatitis har en øget risiko for leverfunktionsabnormaliteter ved antiretroviral kombinationsterapi og bør monitoreres i henhold til standard praksis.
English: The combination of saquinavir and ritonavir exhibited a superior virological activity compared with the indinavir and ritonavir arm when switch from the assigned treatment was counted as virological failure.
Danish: Kombinationen af saquinavir og ritonavir udviste større virologisk aktivitet i forhold til indinavir- og ritonavir-armen, når skift fra den oprindelige behandling blev regnet som virologisk svigt.
English: Clozapine
Danish: Clozapin
English: Safety pharmacology: Cloned human cardiac potassium channel (hERG) trafficking in vitro was inhibited by 75% at 30μM of saquinavir.
Danish: Sikkerhedsfarmakologi: In vitro aktiviteten af klonede humane kardielle kaliumkanaler (hERG) blev hæmmet 75 % ved 30 µM saquinavir.
English: If Invirase is co-administered with parenteral midazolam it should be done in an intensive care unit (ICU) or similar setting which ensures close clinical monitoring and appropriate medical management in case of respiratory depression and/or prolonged sedation.
Danish: Samtidig administration af Invirase og parenteralt administreret midazolam bør foregå på en intensivafdeling eller et lignende sted, hvor nøje klinisk overvågning og passende medicinsk behandling kan foretages i tilfælde af respirationsdepression og/eller forlænget sedation.
English: Other medicinal products Alpha-1 adrenoreceptor antagonist Alfuzosin
Danish: Andre lægemidler Alfa-1-receptorantagonister Alfuzosin
English: * Sum of rifabutin + 25-O-desacetyl rifabutin metabolite
Danish: * Summen af rifabutin + 25-O-desacetylrifabutin-metabolitten.
English: No clinically significant alterations of either saquinavir or efavirenz concentration were noted in studies in healthy volunteers or in HIVinfected patients (see section 4.5).
Danish: Der er ikke set klinisk betydende ændringer i hverken saquinavir- eller efavirenz-koncentrationerne i studier med raske frivillige eller hiv-inficerede patienter (se pkt.
English: It is unknown whether patients with such conditions could receive subtherapeutic saquinavir levels.
Danish: Det vides ikke om behandling af patienter med disse tilstande vil medføre subterapeutiske saquinavirkoncentrationer.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING TEXT FOR THE OUTER CARTON
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE TEKST PÅ DEN YDRE KARTON
English: Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Danish: Yderligere oplysninger om dette lægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/.
English: Dose reduction of the glucocorticoid should be considered with close monitoring of local and systemic effects or a switch to a glucocorticoid, which is not a substrate for CYP3A4 (e.g. beclomethasone).
Danish: Det bør overvejes at reducere dosis af glukokortikoidet samtidig med tæt monitorering af lokale og systemiske bivirkninger eller at skifte til et glukokortikoid, som ikke er substrat for CYP3A4 (f.eks. beclometason).
English: Haloperidol Chlorpromazine Mesoridazine Phenothiazines Sertindole
Danish: Haloperidol Chlorpromazin Mesoridazin Phenothiaziner Sertindol
English: Caution should be exercised when Invirase/ritonavir and digoxin are coadministered.
Danish: Der skal udvises forsigtighed, når Invirase/ritonavir og digoxin administreres samtidigt.
English: A decrease in the dose of the benzodiazepine may be required.
Danish: Det kan blive nødvendigt at nedsætte benzodiazepindosis.
English: Effect of gender following treatment with Invirase/ritonavir: A gender difference was observed with females showing higher saquinavir exposure than males (AUC on average 56 % higher and Cmax on average 26 % higher) in the bioequivalence study comparing Invirase 500 mg film coated tablets with Invirase 200 mg hard capsules both in combination with ritonavir.
Danish: Effekten af køn efter behandling med Invirase/ritonavir: Der blev observeret en kønsforskel, idet kvinder havde højere saquinavireksponering end mænd (AUC gennemsnitligt 56 % højere og Cmax gennemsnitligt 26 % højere) i det bioækvivalensstudie, som sammenlignede Invirase 500 mg filmovertrukne tabletter med Invirase 200 mg hårde kapsler, i begge tilfælde i kombination med ritonavir.
English: Most drug interaction studies with saquinavir have been completed with unboosted Invirase or unboosted saquinavir soft capsules.
Danish: De fleste lægemiddelinteraktionsstudier med saquinavir er udført med ikke-boostet Invirase eller ikkeboostet saquinavir bløde kapsler.
English: Table 6: Subject Demographics MaxCmin1 and MaxCmin2†
Danish: Tabel 6: Patientdemografiske karakteristika for MaxCmin1 og MaxCmin2†
English: Concomitant administration of Invirase and lurasidone is contraindicated as it may increase lurasidone-related toxicity (see section 4.3).
Danish: Samtidig administration af Invirase og lurasidon er kontraindiceret, da det kan øge lurasidon-relateret toksicitet (se pkt.
English: Non-nucleoside reverse transcriptase inhibitors (NNRTIs) - Delavirdine
Danish: Non-nukleosid reverse transkriptasehæmmere (NNRTIs) - Delavirdin
English: Monitoring of neutropenia and liver enzyme levels is recommended due to an expected increase in exposure to rifabutin.
Danish: Det anbefales at monitorere leverenzymniveauerne og for neutropeni pga. en forventet stigning i rifabutineksponeringen.
English: Increased concentrations of simvastatin and lovastatin have been associated with rhabdomyolysis.
Danish: Forhøjede koncentrationer af simvastatin og lovastatin er blevet forbundet med rabdomyolose.
English: Change in Baseline Plasma HIV-1 RNA at Week 4
Danish: Ændring i baselineplasma hiv-1-RNA efter uge 4
English: Table 1: Interactions and dose recommendations with other medicinal products Medicinal product by therapeutic area (dose of
Danish: Tabel 1: Interaktioner og dosisanbefalinger med andre lægemidler
English: Interaction with zalcitabine is unlikely due to different routes of metabolism and excretion.
Danish: - Interaktion med zalcitabin er usandsynlig, da dette lægemiddel har andre metaboliserings- og udskillelsesveje.
English: The primary study variable was maximal change from dense predose baseline in QTcF (ΔQTcFdense).
Danish: Den primære studievariabel var en maksimal ændring fra gennemsnitlig præ-dosis baseline i QTcF intervallet (ΔQTcFgennemsnit).
English: Caution should be used with coadministration of Invirase and parenteral midazolam.
Danish: Der skal udvises forsigtighed ved samtidig administration af Invirase og parenteralt administreret midazolam.
English: PHARMACEUTICAL FORM AND CONTENTS 120 film-coated tablets
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) 120 filmovertrukne tabletter
English: If this is your first medicine for HIV or the first time you are taking ritonavir (Norvir) You need to take a lower dose of Invirase for your first week.
Danish: Hvis det er første gang du får lægemidler mod hiv eller det er første gang du skal tage ritonavir (Norvir)
English: Bone problems: 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: Knogleproblemer: Nogle af de patienter, der får flere antiretrovirale lægemidler på samme tid, kan udvikle en knoglesygdom, der kaldes knoglenekrose (hvor knoglevævet dør på grund af nedsat blodtilførsel til knoglen).
English: Increased blood creatinine
Danish: Forhøjet kreatinin
English: All but one of the patients achieved Ctrough values of saquinavir above the therapeutic threshold (100 ng/ml) in the fasted state.
Danish: Alle undtagen én patient ramte Ctrough værdier for saquinavir over den terapeutiske grænseværdi (100 ng/ml) under fastende betingelser.
English: One plastic (HDPE) bottle contains 120 tablets.
Danish: Plastikglas (HDPE) indeholdende 120 tabletter.
English: ΔQTcFdense ≥ 30 ms (%)
Danish: ΔQTcFgennemsnit ≥ 30 ms
English: Invirase is used by HIV-1-infected adults.
Danish: Invirase anvendes til voksne med hiv-1-infektion.
English: Table 5: Virological response to saquinavir/ritonavir stratified by the number of baseline saquinavirassociated resistance mutations
Danish: Tabel 5: Virologisk respons af saquinavir/ritonavir indelt efter antallet af baseline saquinavirassocierede resistensmutationer.
English: Ketoconazole AUC ↑ 168%
Danish: Ketoconazol AUC ↑ 168 %
English: The plasma exposures (AUC values) in rats (maximum dose 1000 mg/kg/day) and in mice (maximum dose 2500 mg/kg/day) were lower than the expected plasma exposures obtained in humans at the recommended clinical dose of ritonavir boosted Invirase.
Danish: Plasmakoncentrationerne (AUC-værdier) hos rotter (maksimumdosis 1.000 mg/kg/dag) og hos mus (maksimumdosis 2500 mg/kg/dag) var lavere end de forventede plasmakoncentrationer, der blev opnået hos mennesker ved den anbefalede kliniske dosis af Invirase boostet med ritonavir.
English: midazolam suggest a possible 34 fold increase in midazolam plasma levels.
Danish: midazolam tyder på en mulig forhøjelse af midazolams plasmakoncentration på 3-4 gange.
English: The geometric mean ratio (ratio of pharmacokinetic parameters in hepatically impaired patients to patients with normal liver function) (90% confidence interval) was 0.7 (0.3 to 1.6) for both AUC0-12 and Cmax, which suggests approximately 30% reduction in the pharmacokinetic exposure in patients with moderate hepatic impairment.
Danish: Den geometriske gennemsnitsratio (ratioen af farmakokinetiske parametere hos patienter med nedsat leverfunktion i forhold til hos patienter med normal leverfunktion) (90 % konfidensinterval) var 0,7 (0,3 til 1,6) for både AUC0-12 og Cmax, hvilket tyder på ca. 30 % reduktion i den farmakokinetiske eksponering hos patienter med moderat nedsat leverfunktion.
English: • The other ingredients (excipients) are microcrystalline cellulose, croscarmellose sodium, povidone, lactose (monohydrate) 38.5 mg, magnesium stearate, hypromellose, titanium dioxide (E171), talc, glycerol triacetate, iron oxide yellow (E172) and iron oxide red (E172).
Danish: • Øvrige indholdsstoffer (hjælpestoffer): mikrokrystallinsk cellulose, croscarmellosenatrium, povidon, lactose (monohydrat) 38,5 mg, magnesiumstearat, hypromellose, titandioxid (E171), talcum, glyceroltriacetat, gul jernoxid (E172) og rød jernoxid (E172).
English: The following adverse events were reported with the highest severity (grades 3 and 4): anaemia, diabetes mellitus, diarrhoea, nausea, vomiting and fatigue.
Danish: Følgende bivirkninger blev rapporteret med højest grad af alvorlighed (grad 3 og 4): Anæmi, diabetes mellitus, diarré, kvalme, opkastning og træthed.
English: These results suggest that the QTc liability is reduced with the modified Invirase/ritonavir dosing regimen, based on a cross-study comparison in a different population (Table 4).
Danish: Disse resultater tyder på, at det modificerede Invirase/ritonavir-dosisregime reducerer påvirkningen af QTc, baseret på en sammenligning på tværs af studier i en anden population (tabel 4).
English: Also contains lactose (monohydrate) 38.5 mg, colourants (titanium dioxide E 171, iron oxide E 172) and other constituents.
Danish: Indeholder også lactose (monohydrat) 38,5 mg, farvestoffer (titandioxid E 171, jernoxid E 172) og andre hjælpestoffer.
English: Ritonavir inhibits the metabolism of saquinavir, thereby increasing ("boosting") the plasma levels of saquinavir.
Danish: Ritonavir hæmmer metaboliseringen af saquinavir og øger (”booster”) derved plasmaniveauerne af saquinavir.
English: • sedative agents - such as midazolam administered by injection
Danish: • beroligende lægemidler - såsom midazolam indgivet ved injektion