FrancophonIA/ELRC3.0 huggingface dataset:
English: At 84 mg twice daily dosing with eliglustat in non-PMs, it is predicted that concomitant use of moderate CYP2D6 inhibitors (e.g. duloxetine, terbinafine, moclobemide, mirabegron, cinacalcet, dronedarone) would increase eliglustat exposure approximately up to 4-fold.
Danish: Ved en dosering af eliglustat på 84 mg to gange hos ikke-PM'er dagligt forudses det, at samtidig brug af moderate CYP2D6-hæmmere (f.eks. duloxetin, terbinafin, moclobemid, mirabegron, cinacalcet, dronedaron) vil give anledning til cirka op til en 4-gange størreeksponeringen af eliglustat.
English: Ελλάδα sanofi-aventis AEBE
Danish: Ελλάδα/Κύπρος sanofi-aventis AEBE (Ελλάδα)
English: • Stomach ache (upper abdominal pain)
Danish: • Mavepine (øvre mavesmerter)
English: In CYP2D6 extensive metabolisers (EMs) with mild, moderate or severe renal impairment, no dosage adjustment is required and the recommended dose is 84 mg eliglustat twice daily (see sections 4.4 and 5.2).
Danish: Hos CYP2D6-ekstensive metabolisatorer (EM'er) med let, moderat eller alvorlig nedsat nyrefunktion er det ikke nødvendigt at justere dosis, og den anbefalede dosis er 84 mg eliglustat to gange dagligt (se pkt.
English: After a single 84 mg dose, eliglustat Cmax and AUC were 1.2- and 1.2-fold higher in CYP2D6 extensive metabolisers (EMs) with mild hepatic impairment, and 2.8- and 5.2-fold higher in CYP2D6 extensive metabolisers (EMs) with moderate hepatic impairment compared to healthy CYP2D6 extensive metabolisers (EMs).
Danish: Efter en enkelt dosis på 84 mg var eliglustat Cmax og AUC 1,2 og 1,2 gange højere hos CYP2D6-ekstensive metabolisatorer (EM'er) med let nedsat leverfunktion og 2,8 og 5,2 gange højere hos CYP2D6ekstensive metabolisatorer (EM'er) med moderat nedsat leverfunktion sammenlignet med raske CYP2D6-ekstensive metabolisatorer (EM'er).
English: In CYP2D6 extensive metabolisers (EMs) with moderate hepatic impairment (Child-Pugh class B), eliglustat is not recommended (see sections 4.4 and 5.2).
Danish: Hos CYP2D6-ekstensive metabolisatorer (EM´er) med moderat nedsat leverfunktion (Child-Pugh klasse B) anbefales eliglustat ikke (se pkt.
English: Due to significantly increased eliglustat plasma concentrations, Cerdelga is contraindicated in CYP2D6 extensive metabolisers (EMs) with severe hepatic impairment and in CYP2D6 extensive metabolisers (EMs) with mild or moderate hepatic impairment taking a strong or moderate CYP2D6 inhibitor (see sections 4.2 and 5.2).
Danish: På grund af signifikant øgede eliglustat-plasmakoncentrationer er Cerdelga kontraindiceret hos CYP2D6-ekstensive metabolisatorer (EM´er) med alvorlig nedsat leverfunktion og hos CYP2D6ekstensive metabolisatorer (EM´er) med let eller moderat nedsat leverfunktion, som tager en stærk eller moderat CYP2D6-hæmmer (se pkt.
English: CYP2D6 inhibitors used simultaneously with CYP3A inhibitors In intermediate (IMs) and extensive metabolisers (EMs):
Danish: CYP2D6-hæmmere, der bruges samtidig med CYP3A-hæmmere Hos intermediære metabolisatorer (IM'er) og ekstensive metabolisatorer (EM'er):
English: • are an intermediate or poor metaboliser and you have reduced kidney function.
Danish: • er en intermediær eller en langsom metabolisator, og du har nedsat nyrefunktion.
English: At 84 mg once daily dosing with eliglustat in PMs, it is predicted that concomitant use of strong CYP3A inhibitors (e.g. ketoconazole, clarithromycin, itraconazole, cobicistat, indinavir, lopinavir, ritonavir, saquinavir, telaprevir, tipranavir, posaconazole, voriconazole, telithromycin, conivaptan, boceprevir) would increase the Cmax and AUC0-24 of eliglustat 4.3- and 6.2-fold.
Danish: Ved en dosering med eliglustat på 84 mg en gang dagligt hos PM'er, forudsiges det, at samtidig brug af potente CYP3A-hæmmere (f.eks. ketoconazol, clarithromycin, itraconazol, cobicistat, indinavir, lopinavir, ritonavir, saquinavir, telaprevir, tipranavir, posaconazol, voriconazol, telithromycin, conivaptan, boceprevir) vil forøge Cmax og AUC0-24 af eliglustat med 4,3- og 6,2 gange.
English: Limited or no data were available in patients with ESRD and in CYP2D6 intermediate metabolisers (IMs) or poor metabolisers(PMs) with severe renal impairment (see sections 4.2 and 4.4).
Danish: Begrænset eller ingen data var tilgængelige hos patienter med ESRD og hos CYP2D6-intermediære metabolisatorer (IM'er) eller langsomme metabolisatorer (PM'er) med alvorlig nedsat nyrefunktion (se pkt.
English: Haemoglobin Level Percentage of Patients with stable haemoglobin levela
Danish: Trombocyttal Procentdel af patienter med stabile trombocyttala
English: CYP2D6 inhibitors In intermediate (IMs) and extensive metabolisers (EMs):
Danish: CYP2D6-hæmmere Hos intermediære metabolisatorer (IM'er) og ekstensive metabolisatorer (EM'er):
English: The recommended dose is 84 mg eliglustat twice daily in CYP2D6 intermediate metabolisers (IMs) and extensive metabolisers (EMs).
Danish: Den anbefalede dosis er 84 mg eliglustat to gange dagligt hos CYP2D6-intermediære metabolisatorer (IM'er) og ekstensive metabolisatorer (EM'er).
English: Arthralgia, pain in extremity*, back pain* General disorders and administration site conditions Fatigue
Danish: Artralgi, smerter i ekstremiteterne*, rygsmerter*
English: In CYP2D6 intermediate metabolisers (IMs) or poor metabolisers (PMs) with mild, moderate or severe renal impairment or ESRD, eliglustat is not recommended (see sections 4.4 and 5.2).
Danish: Hos CYP2D6-intermediære metabolisatorer (IM´er) eller langsomme metabolisatorer med let, moderat eller alvorlig nedsat nyrefunktion eller ESRD anbefales eliglustat ikke (se pkt.
English: o Caution should be used with moderate CYP2D6 inhibitors in intermediate metabolisers (IMs) and extensive metabolisers (EMs).
Danish: • Der bør udvises forsigtighed med moderate CYP2D6-hæmmere hos intermediære metabolisatorer (IM´er) og ekstensive metabolisatorer (EM'er).
English: At 84 mg once daily dosing with eliglustat in PMs, it is predicted that concomitant use of moderate CYP3A inhibitors (e.g. erythromycin, ciprofloxacin, fluconazole, diltiazem, verapamil, aprepitant, atazanavir, darunavir, fosamprenavir, imatinib, cimetidine) would increase the Cmax and AUC0-24 of eliglustat 2.4- and 3.0-fold, respectively.
Danish: Ved en dosering med eliglustat på 84 mg en gang dagligt hos PM'er, forudsiges det, at samtidig brug af moderate CYP3A-hæmmere (f.eks. erythromycin, ciprofloxacin, fluconazol, diltiazem, verapamil, aprepitant, atazanavir, darunavir, fosamprenavir, imatinib, cimetidin) vil forøge Cmax og AUC0-24 af eliglustat med henholdsvis 2,4- og 3,0-gange.
English: CYP2D6 ultra-rapid metabolisers (URMs) and indeterminate metabolisers Eliglustat should not be used in patients who are CYP2D6 ultra-rapid metabolisers (URMs) or indeterminate metabolisers (see section 4.4).
Danish: Eliglustat må ikke bruges hos patienter, der er CYP2D6-ultra-hurtige metabolisatorer (URM'er) eller ubestemte metabolisatorer (se pkt.
English: ** All patients transitioned to Cerdelga treatment after 52 weeks a The stability criteria based on changes between baseline and 12 months: haemoglobin level ≤1.5 g/dL decrease, platelet count ≤25% decrease, liver volume ≤20% increase, and spleen volume ≤25% increase.
Danish: ≤ 1,5 g/dl fald, trombocyttal ≤ 25 % fald, levervolumen ≤ 20 % stigning og miltvolumen ≤ 25 %
English: The recommended dose is 84 mg eliglustat once daily in CYP2D6 poor metabolisers (PMs).
Danish: Den anbefalede dosis er 84 mg eliglustat en gang dagligt for CYP2D6-langsomme metabolisatorer (PM'er).
English: At 84 mg twice daily dosing with eliglustat in non-PMs, it is predicted that concomitant use of moderate CYP3A inhibitors (e.g. erythromycin, ciprofloxacin, fluconazole, diltiazem, verapamil, aprepitant, atazanavir, darunavir, fosamprenavir, imatinib, cimetidine) would increase eliglustat exposure approximately up to 3-fold.
Danish: Ved en dosering med eliglustat på 84 mg to gange dagligt hos ikke-PM'er forventes det, at samtidig brug af moderate CYP3A-hæmmere (f.eks. erythromycin, ciprofloxacin, fluconazol, diltiazem, verapamil, aprepitant, atazanavir, darunavir, fosamprenavir, imatinib, cimetidin) vil øge eksponeringen for eliglustat med ca. op til en 3-dobling.
English: • Feeling sick (nausea)
Danish: • Utilpashed (kvalme)
English: Black iron oxide (E172) Propylene glycol Ammonia solution, concentrated
Danish: Sort jernoxid (E172) Propylenglycol
English: o In CYP2D6 extensive metabolisers (EMs) with mild hepatic impairment taking a weak CYP2D6 inhibitor or a strong, moderate or weak CYP3A inhibitor, a dose of 84 mg eliglustat once daily should be considered.
Danish: • Hos CYP2D6-ekstensive metabolisatorer (EM´er) med let nedsat leverfunktion, som tager en svag CYP2D6-hæmmer eller stærk, moderat eller svag CYP3A-hæmmer, bør en dosis eliglustat 84 mg en gang dagligt overvejes.
English: Caution should be used with strong CYP3A inhibitors in IMs and EMs.
Danish: Der skal udvises forsigtighed med potente CYP3A-hæmmere hos IM'er og EM'er.
English: Caution should be used with moderate CYP3A inhibitors in IMs and EMs.
Danish: Der skal udvises forsigtighed med moderate CYP3A-hæmmere hos IM'er og EM'er.
English: In CYP2D6 intermediate metabolisers (IMs) or poor metabolisers (PMs) with any degree of hepatic impairment, eliglustat is not recommended (see sections 4.4 and 5.2).
Danish: Hos CYP2D6-intermediære metabolisatorer (IM'er) eller -langsomme metabolisatorer (PM'er) med nogen grad af nedsat leverfunktion, anbefales eliglustat ikke (se pkt.
English: Patients who are CYP2D6 intermediate metabolisers (IMs) or extensive metabolisers (EMs) taking a strong or moderate CYP2D6 inhibitor concomitantly with a strong or moderate CYP3A inhibitor, and patients who are CYP2D6 poor metabolisers (PMs) taking a strong CYP3A inhibitor.
Danish: Patienter, som er CYP2D6-intermediære metabolisatorer (IM'er) eller ekstensive metabolisatorer (EM'er) og som tager en stærk eller moderat CYP2D6-hæmmer samtidig med en stærk eller moderat CYP3A-hæmmer, og patienter, som er CYP2D6-langsomme metabolisatorer (PM'er), og som tager en stærk CYP3A-hæmmer.
English: • Joint pain (arthalagia)
Danish: • Ledsmerter (artralgi)
English: • Inflammation of the stomach (gastritis)
Danish: • Mavekatar (gastritis)
English: Spleen Volume Patients with stable spleen volume (%)*
Danish: Miltvolumen Patienter med stabil miltvolumen (%)* Ændringer i miltvolumen MN (%)*
English: In CYP2D6 extensive metabolisers (EMs) with mild hepatic impairment taking a weak CYP2D6 inhibitor or a strong, moderate or weak CYP3A inhibitor, a dose of 84 mg eliglustat once daily should be considered (see sections 4.4 and 5.2).
Danish: Hos CYP2D6-ekstensive metabolisatorer (EM´er) med let nedsat leverfunktion, som tager en svag CYP2D6-hæmmer eller en stærk, moderat eller svag CYP3A-hæmmer, bør en dosis på 84 mg eliglustat en gang dagligt overvejes (se pkt.
English: In extensive metabolisers (EMs) with moderate or severe hepatic impairment: see sections 4.2 and 4.3.
Danish: Hos ekstensive metabolisatorer (EM'er) med moderat eller alvorlig nedsat leverfunktion: se pkt.
English: In CYP2D6 extensive metabolisers (EMs) with mild hepatic impairment taking a weak CYP2D6 inhibitor or strong, moderate or weak CYP3A inhibitor, a dose of 84 mg eliglustat mg once daily should be considered (see sections 4.2 and 5.2).
Danish: Hos CYP2D6-ekstensive metabolisatorer (EM'er) med let nedsat leverfunktion, som tager en svag CYP2D6-hæmmer eller stærk, moderat eller svag CYP3A-hæmmer, bør en dosis på 84 mg eliglustat en gang dagligt overvejes (se pkt.
English: o Eliglustat is contraindicated in patients who are CYP2D6 intermediate metabolisers (IMs) or extensive metabolisers (EMs) who are taking a strong or moderate CYP2D6 inhibitor concomitantly with a strong or moderate CYP3A inhibitor.
Danish: • Eliglustat er kontraindiceret til patienter, som har gennemsnitlig (IM´er) eller omfattende (EM´er) CYP2D6 metabolisering, som tager en stærk eller moderat CYP2D6-hæmmer samtidigt med en stærk eller moderat CYP3A-hæmmer.
English: In the Cerdelga group 34 (32%) patients received a dose escalation to 84 mg eliglustat twice daily and 51 (48%) to 127 mg twice daily during the 12month primary analysis period , and 21 (20%) patients continued to receive 42 mg twice daily.
Danish: Pivotal studie af Cerdelga hos GD1-patienter, der skiftede fra ERT- Studie 02607 (ENCORE) Studie 02607 var et randomiseret, open-label, aktivt kontrolleret, multicenter klinisk noninferioritetsstudie med 159 patienter, som tidligere blev stabiliseret med ERT. I Cerdelga-gruppen modtog 34 (32 %) patienter en dosisoptrapning til 84 mg eliglustat to gange dagligt og 51 (48 %) til 127 mg to gange dagligt under den primære 12-måneders analyseperiode og 21 (20 %) patienter fortsatte med at modtage 42 mg to gange dagligt.
English: In extensive metabolisers (EMs) with severe hepatic impairment: see sections 4.2 and 4.3.
Danish: Hos ekstensive metabolisatorer (EM'er) med alvorlig nedsat leverfunktion: se pkt.
English: Cerdelga is contraindicated in patients who are CYP2D6 intermediate metabolisers (IMs) or extensive metabolisers (EMs) taking a strong or moderate CYP2D6 inhibitor concomitantly with a strong or moderate CYP3A inhibitor, and in patients who are CYP2D6 poor metabolisers (PMs) taking a strong CYP3A inhibitor (see section 4.3).
Danish: Cerdelga er kontraindiceret hos patienter, som er CYP2D6-intermediære metabolisatorer (IM'er) eller ekstensive metabolisatorer (EM'er), og som tager en stærk eller moderat CYP2D6-hæmmer samtidig med en stærk eller moderat CYP3A-hæmmer og hos patienter, som er CYP2D6-langsomme metabolisatorer (PM'er), og som tager en stærk CYP3A-hæmmer (se pkt.
English: Percentage of Patients with stable platelet counta
Danish: Procentdel af patienter med stabilt hæmoglobinniveaua
English: o In CYP2D6 extensive metabolisers (EMs) with severe hepatic impairment, Cerdelga is contraindicated.
Danish: • Cerdelga er kontraindiceret hos CYP2D6-ekstensive metabolisatorer (EM´er) med alvorlig nedsat leverfunktion.
English: Sanofi S.p.A. Tel: 800536389
Danish: Tel: +800536389
English: In extensive metabolisers (EMs) with mild hepatic impairment: see sections 4.2 and 4.4.
Danish: Hos ekstensive metabolisatorer (EM'er) med let nedsat leverfunktion: se pkt.
English: o The recommended dose is 84 mg eliglustat twice daily in CYP2D6 intermediate metabolisers (IMs) and extensive metabolisers (EMs).
Danish: • Den anbefalede dosis er 84 mg eliglustat to gange om dagen til personer med gennemsnitlig (IM'er) og omfattende (EM'er) CYP2D6 metabolisering.
English: In extensive metabolisers (EMs) with mild or moderate hepatic impairment: see sections 4.2, 4.3 and
Danish: Hos ekstensive metabolisatorer (EM'er) med let eller moderat nedsat leverfunktion: se pkt.
English: o In CYP2D6 intermediate metabolisers (IMs) or poor metabolisers (PMs) with any degree of hepatic impairment, Cerdelga is not recommended.
Danish: • Cerdelga anbefales ikke til CYP2D6-intermediære metabolisatorer (IM´er) eller langsomme metabolisatorer (PM´er) med nogen grad af nedsat leverfunktion.
English: In CYP2D6 extensive metabolisers (EMs) with severe (Child-Pugh class C) hepatic impairment, eliglustat is contraindicated (see sections 4.3 and 5.2).
Danish: Eliglustat er kontraindiceret hos CYP2D6-ekstensive metabolisatorer (EM´er) med alvorlig nedsat leverfunktion (Child-Pugh klasse C) (se pkt.
English: Cerdelga is indicated in patients who are CYP2D6 poor metabolisers (PMs), intermediate metabolisers (IMs) or extensive metabolisers (EMs).
Danish: som er har dårlig CYP2D6-metabolisering (poor metabolisers, PM'er), gennemsnitlig metabolisering (intermediate metabolisers, IM'er) eller omfattende metabolisering (extensive metabolisers, EM'er).
English: Description
Danish: Opbevaring
English: How to store Cerdelga
Danish: Opbevaring af Cerdelga
English: • you have switched from a different medicine
Danish: • du har skiftet fra et andet lægemiddel
English: You will be instructed in:
Danish: Du vil blive instrueret i:
English: Date of first authorisation: 14 April 2011 Date of first renewal: 18 February 2016
Danish: Dato for første markedsføringstilladelse: 14. april 2011 Dato for første fornyelse: 18. februar 2016
English: Therefore, your baby may be protected from certain infections.
Danish: Derfor kan din baby være beskyttet mod visse infektioner.
English: The following dose regimens are given as a guideline.
Danish: Følgende doseringsregimer gives som en retningslinje.
English: Consequences of an overdose are not known.
Danish: Konsekvenserne ved overdosering kendes ikke.
English: (agammaglobulinaemia) in the blood
Danish: (agammaglobulinæmi) i blodet
English: Do not use solutions that have been frozen.
Danish: Anvend ikke opløsninger, der har været nedfrosset.
English: Record the following data in your treatment diary:
Danish: Registrér følgende oplysninger i din behandlingsdagbog:
English: It is usually prepared from pooled plasma from not fewer than 1,000 donors.
Danish: Det fremstilles som regel ud fra plasmapools fra ikke mindre end 1.000 donorer.
English: In accordance with Article 114 of Directive 2001/83/EC, the official batch release will be undertaken by a state laboratory or a laboratory designated for that purpose.
Danish: I henhold til artikel 114 i Direktiv 2001/83/EF foretages den officielle batchfrigivelse af et statsligt laboratorium eller et laboratorium udpeget hertil.
English: There is no limit to the number of infusion sites.
Danish: Der er ingen grænse for antallet af infusionssteder.
English: • measures to be taken in case of severe side effects.
Danish: • hvad du skal gøre i tilfælde af alvorlige bivirkninger.
English: In these cases, it is recommended that you are monitored during the first infusion and for an hour afterwards.
Danish: I disse tilfælde bør du overvåges under den første infusion og i en time derefter.
English: 11 Clean up
Danish: 11 Gør rent
English: This may need to be divided over several days.
Danish: Denne dosis skal muligvis fordeles over flere dage.
English: Start infusion.
Danish: Start infusionen.
English: Absorption and Distribution
Danish: Absorption og fordeling
English: If the points above do not apply for you it is recommended that you are observed for at least 20 minutes after administration.
Danish: Hvis ovennævnte punkter ikke gælder for dig, anbefales det, at du observeres i mindst 20 minutter efter indgivelse.
English: • Increased blood pressure (hypertension)
Danish: • Forhøjet blodtryk (hypertension)
English: Continued treatment of the pregnant woman ensures a passive immunity for the neonate.
Danish: Fortsat behandling af den gravide kvinde sikrer en passiv immunitet hos det nyfødte barn.
English: All other patients should be observed for at least 20 minutes after administration.
Danish: Alle andre patienter bør observeres i mindst 20 minutter efter indgivelse.
English: Interference with serological testing
Danish: Interferens ved serologisk testning
English: Elimination IgG and IgG-complexes are broken down in cells of the reticuloendothelial system.
Danish: Elimination IgG- og IgG-komplekser nedbrydes i cellerne i det retikuloendoteliale system.
English: However, true allergic reactions are rare.
Danish: Ægte allergiske reaktioner er imidlertid sjældne.
English: The recommended initial infusion rate depends on the individual patient's needs.
Danish: Den anbefalede indledende infusionshastighed afhænger af den enkelte patients behov.
English: Subjects generally used 4 infusion sites in parallel (up to 8 sites in parallel).
Danish: Forsøgspersonerne anvendte generelt 4 infusionssteder parallelt (op til 8 steder parallelt).
English: Finally, withdraw the desired volume of Hizentra.
Danish: Udtræk så den ønskede mængde af Hizentra.
English: Please see also section 2 of this leaflet about the risk of allergic reactions, blood clots and AMS.
Danish: Se også afsnit 2 i denne indlægsseddel vedrørende risikoen for allergiske reaktioner, blodpropper og AMS.
English: These things may increase your risk of having a blood clot after using Hizentra.
Danish: Disse ting kan øge din risiko for at få en blodprop efter at have brugt Hizentra.
English: ► into a blood vessel.
Danish: ► i et blodkar.
English: • Involuntary shaking movements in one or more parts of the body (tremor, including psychomotor hyperactivity)
Danish: •Ufrivillige rystelser i en eller flere dele af kroppen (tremor, herunder psykomotorisk hyperaktivitet)
English: The dose and dose regimen are dependent on the indication.
Danish: Dosis og dosisregimen afhænger af indikationen.
English: • the keeping of a treatment diary, and
Danish: • at føre en behandlingsdagbog og
English: Each single dose may need to be injected at different anatomic sites.
Danish: Det kan være nødvendigt at injicere hver enkeltdosis på forskellige anatomiske steder.
English: The dose may need to be adapted to achieve the desired clinical response.
Danish: Det kan være nødvendigt at justere dosis for at opnå det ønskede kliniske respons.
English: If this happens, you should not drive or use machines until these effects have disappeared.
Danish: Hvis dette sker for dig, må du ikke føre motorkøretøj eller betjene maskiner, før disse bivirkninger er forsvundet.
English: • Chills, including low body temperature
Danish: • Kuldegysninger, herunder lav kropstemperatur
English: True allergic reactions are rare.
Danish: Ægte allergiske reaktioner er sjældne.
English: ► that you are carefully monitored for any symptoms throughout the infusion period, especially if:
Danish: ► du overvåges nøje for eventuelle symptomer gennem hele infusionsperioden, særligt hvis:
English: The mechanism of action in indications other than replacement therapy is not fully elucidated, but includes immunomodulatory effects.
Danish: Virkningsmekanismen ved andre indikationer end substitutionsterapi er ikke fuldt belyst, men inkluderer immunmodulerende virkninger.
English: Overall, the number of infusions without severe local reactions versus the total number of infusions (tolerability) was ≥ 0.98 in all groups for all infusion parameters.
Danish: Samlet set var antallet af infusioner uden svære lokale reaktioner i forhold til det totale antal infusioner (tolerabilitet) ≥ 0,98 i alle grupper for alle infusionsparametre.
English: Also tell your doctor what drugs you are using, as some drugs, such as those that contain the hormone estrogen (for example, birth control pills), may increase your risk of developing a blood clot.
Danish: Fortæl også lægen, hvilke lægemidler du bruger, da visse lægemidler som f.eks. hormonet østrogen (f.eks. p-piller), kan øge din risiko for at udvikle en blodprop.
English: The ADRs reported in these clinical studies are summarised and categorised according to the MedDRA System Organ Class (SOC and Preferred Term level) and frequency below.
Danish: De bivirkninger, der blev rapporteret i disse kliniske studier, er opsummeret og kategoriseret i henhold til MedDRA-systemorganklasser (SOC og foretrukken term) og hyppighed nedenfor.
English: You must not mix other medicines with Hizentra.
Danish: Du må ikke blande anden medicin med Hizentra.
English: Hizentra has an approximate osmolality of 380 mOsmol/kg.
Danish: Hizentra har en anslået osmolalitet på 380 mOsmol/kg.
English: Tremor (including Psychomotor hyperactivity)
Danish: Tremor (herunder psykomotorisk hyperaktivitet)
English: • Periodic safety update reports (PSURs)
Danish: Periodiske, opdaterede sikkerhedsindberetninger (PSUR'er)
English: This includes conditions such as:
Danish: Dette omfatter lidelser som f.eks.:
English: The primary endpoint was the percentage of subjects responding to a higher infusion parameter:
Danish: Det primære endepunkt var procentdelen af forsøgsdeltagere, der responderede på en højere infusionsparameter:
English: Fatigue (including Malaise), Pyrexia
Danish: Træthed (herunder utilpashed), pyreksi
English: ► if you suffer from hyperprolinaemia (a genetic disorder causing high levels of the amino acid proline in the blood).
Danish: ► Hvis du lider af hyperprolinæmi (en genetisk lidelse, der forårsager høje niveauer af aminosyren prolin i blodet).
English: D-35041 Marburg
Danish: 35041 Marburg
English: Trough levels should be measured and assessed in conjunction with the patient's clinical response.
Danish: Dalniveauerne bør måles og vurderes i forening med patientens kliniske respons.