FrancophonIA/ELRC3.0 huggingface dataset:
English: Table 1: Adverse reactions reported with lanadelumab
Danish: Tabel 1: Bivirkninger, der er indberettet med lanadelumab
English: This medicine has negligible influence on the ability to drive or use machines.
Danish: Denne medicin påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: Store in a refrigerator (2C-8C).
Danish: Opbevares i køleskab (2 C - 8 C).
English: Always use this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you.
Danish: Brug altid lægemidlet nøjagtigt som beskrevet i denne indlægsseddel eller efter lægens, apotekspersonalets eller sundhedspersonalets anvisning.
English: The HELP study was a multicenter, randomised, double-blind, placebo-controlled parallel-group study in 125 (115 adults and 10 adolescents) subjects with symptomatic type I or II HAE.
Danish: HELP-studiet var et randomiseret, dobbeltblindet, placebokontrolleret, multicenterstudie med parallelle grupper, der omfattede 125 (115 voksne og 10 unge) forsøgspersoner med symptomatisk hereditært angioødem af type I eller II.
English: • The other ingredients are disodium phosphate dihydrate, citric acid monohydrate, histidine, sodium chloride, polysorbate 80 and water for injections - see section 2 “TAKHZYRO contains sodium” What TAKHZYRO looks like and contents of the pack
Danish: Øvrige indholdsstoffer: dinatriumphosphatdihydrat, citronsyremonohydrat, histidin, natriumklorid, polysorbat 80 og vand til injektionsvæsker - se punkt 2 "TAKHZYRO indeholder natrium".
English: The site of SC injection (thigh, arm, or abdomen) and self-administration did not affect the absorption of lanadelumab.
Danish: Stedet for subkutan injektion (lår, arm eller abdomen) og selvadministration påvirkede ikke absorptionen af lanadelumab.
English: The safety and efficacy of TAKHZYRO in children aged less than 12 years have not been established.
Danish: TAKHZYROs sikkerhed og virkning hos børn under 12 år er ikke klarlagt.
English: In case of a breakthrough HAE attack, individualized treatment should be initiated with an approved rescue medication.
Danish: Ved et gennembrudsanfald af hereditært angioødem skal der påbegyndes individualiseret behandling med godkendt akutmedicin.
English: No dose adjustment is required for patients above 65 years of age (see section 5.2).
Danish: Det er ikke nødvendigt at justere dosis hos patienter over 65 år (se pkt.
English: Name and address of the manufacturer(s) of the biological active substance(s) Rentschler Biopharma SE
Danish: Navn og adresse på fremstilleren (fremstillerne) af det (de) biologisk aktive stof(fer) Rentschler Biopharma SE
English: Hypersensitivity reactions have been observed.
Danish: Der er observeret allergiske reaktioner.
English: Do not shake the vial as this can cause foaming.
Danish: Ryst ikke hætteglasset, da det kan forårsage skumdannelse.
English: Change the needle on the syringe to a 27 gauge needle or other needle suitable for SC injection.
Danish: Udskift kanylen på sprøjten med 27 gauge-kanylen eller en anden kanyle, der er egnet til en subkutan injektion.
English: Carcinogenicity has not been evaluated in animals as based on the weight of evidence approach, lanadelumab is considered to have a low risk for carcinogenicity.
Danish: Der er ikke foretaget karcinogenicitetsvurderinger hos dyr, eftersom lanadelumab vurderes at have en lav karcinogenicitetsrisiko ud fra en tilgang med evidensvægt.
English: Human IgGs are known to be excreted in breast milk during the first few days after birth, which is decreasing to low concentrations soon afterwards; consequently, a risk to the breast-fed child cannot be excluded during this short period.
Danish: Humane IgG'er vides at udskilles i brystmælk i de første par dage efter fødslen, men falder til lavere koncentrationer snart derefter.
English: Lanadelumab can increase activated partial thromboplastin time (aPTT) due to an interaction of lanadelumab with the aPTT assay.
Danish: Lanadelumab kan øge aktiveret partiel thromboplastintid (aPTT) på grund af en interaktion med aPTT-analysen.
English: In the ePPND study in pregnant cynomolgus monkeys administered once weekly doses of 10 or 50 mg/kg (highest dose tested), there were no lanadelumab-related effects on pregnancy and parturition, embryo-foetal development, survival, growth, and/or postnatal development of offspring.
Danish: I et ePPND-studie med drægtige cynomolgusaber, der fik doser på 10 eller 50 mg/kg (højeste afprøvede dosis) én gang ugentligt, var der ingen lanadelumab-relaterede virkninger på drægtighed og fødsel, embryo-føtal udvikling, overlevelse, vækst og/eller postnatal udvikling hos afkommet.
English: TAKHZYRO is a medicine used in adults, and adolescents aged 12 years and older to prevent angioedema attacks, in patients with HAE.
Danish: TAKHZYRO er et lægemiddel, der anvendes til voksne og unge på 12 år og derover til forebyggelse af angioødemanfald hos patienter med HAE.
English: Although body weight was identified as an important covariate describing the variability of clearance, a 300 mg q2wks dose regimen provided sufficient exposure for the indication (see section 5.1).
Danish: Selvom kropsvægt blev klarlagt som en vigtig kovarians, der beskriver variabiliteten i clearance, giver et dosisregimen på 300 mg hver 2. uge tilstrækkelig eksponering til indikationen (se pkt.
English: The rate ratio is ratio of the model-based treatment period HAE attack rates.
Danish: Rate ratio er ratioen for HAEanfaldshyppigheden i den modelbaserede behandlingsperiode.
English: HELP study extension
Danish: Forlængelse af HELP-studiet
English: As expected, concomitant use of the rescue medication C1 esterase inhibitor results in an additive effect on lanadelumab-cHMWK response based on the mechanism of action (MOA) of lanadelumab and C1 esterase inhibitor (see section 5.1).
Danish: Som forventet medfører samtidig brug af en C1-esterasehæmmer som akutmedicin en additiv virkning på lanadelumab-cHMWK-responset baseret på lanadelumabs og C1-esterasehæmmerens virkningsmekanisme (se pkt.
English: There are no or limited data from the use of lanadelumab in pregnant women.
Danish: Der er ingen eller utilstrækkelige data fra anvendelse af lanadelumab til gravide kvinder.
English: In a population pharmacokinetic analysis, after correcting for body weight, no influence of gender or age (12 to 75 years) was apparent on the clearance or volume of distribution of lanadelumab.
Danish: I en populationsfarmakokinetisk analyse, med korrigering for kropsvægt, havde hverken køn eller alder (12 til 75 år) nogen tilsyneladende indvirkning på lanadelumabs clearance eller fordelingsvolumen.
English: • Blood tests showing liver changes
Danish: Muskelsmerter lodtests viser ændringer i leveren
English: TAKHZYRO contains the active substance lanadelumab.
Danish: TAKHZYRO indeholder det aktive stof lanadelumab.
English: The percentage of patients who were attack free for the last 16-weeks (Day 70 to Day 182) of the study was 77% in the 300 mg q2wks group, compared to 3% of patients in the placebo group.
Danish: Procentdelen af patienter, der ikke oplevede nogen anfald i de sidste 16 uger (dag 70 til dag 182) af forsøget, var 77 % i gruppen, der fik 300 mg hver 2. uge, sammenlignet med 3 % af patienterne i placebogruppen.
English: Important: Be sure to keep the tip of the needle in the liquid to avoid drawing air in as you pull back the plunger.
Danish: Vigtigt: Sørg for at holde kanylens spids nede i væsken, så du undgår at trække luft med ind, idet du trækker stemplet tilbage.
English: d) Gently pinch about 3 cm of skin at your cleaned injection site and insert the needle.
Danish: d) Klem forsigtigt ca. 3 cm hud sammen på det rensede injektionssted, og indfør kanylen.
English: *Lanadelumab is produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology.
Danish: *Lanadelumab er fremstillet ved rekombinant DNA-teknologi i ovarieceller fra kinesiske hamstere (CHO-celler).
English: The most commonly (52.4%) observed adverse reaction associated with TAKHZYRO was injection site reactions (ISR) including injection site pain, injection site erythema and injection site bruising.
Danish: Den mest almindeligt (52,4 %) observerede bivirkning forbundet med TAKHZYRO var reaktioner på injektionsstedet, herunder smerter på injektionsstedet, erytem på injektionsstedet og blå mærker på injektionsstedet.
English: g) Remove the plastic cap from the vial.
Danish: g) Fjern plastikhætten fra hætteglasset.
English: Lanadelumab's effect on fertility has not been evaluated in humans.
Danish: Lanadelumabs virkning på fertiliteten er ikke blevet evalueret hos mennesker.
English: Based on the characteristics of lanadelumab, no pharmacokinetic interactions with co-administered medicinal products is expected.
Danish: Baseret på lanadelumabs egenskaber forventes der ingen farmakokinetiske interaktioner ved samtidig administration af andre lægemidler.
English: 2 ml of solution in a vial (type I glass) with a coated butyl rubber stopper and an aluminium seal with violet flip-off cap.
Danish: 2 ml opløsning i et hætteglas (type I glas) med en belagt butylgummiprop og en aluminiumsforsegling med en lilla flip-off-hætte.
English: • The outer area of the upper arm is not recommended if you are injecting yourself.
Danish: • Overarmens udvendige side er ikke egnet til selv-indgivelse.
English: As IgG monoclonal antibodies are mainly eliminated via intracellular catabolism, renal impairment or hepatic impairment is not expected to influence clearance of lanadelumab.
Danish: Da IgG monoklonale antistoffer hovedsageligt elimineres via intracellulær katabolisme forventes nedsat nyre- eller leverfunktion ikke at have nogen indvirkning på lanadelumabs clearance.
English: TAKHZYRO should be administered within 2 hours of preparing the dosing syringe.
Danish: TAKHZYRO bør administreres inden for 2 timer efter klargøring af doseringssprøjten.
English: Do not pull on the plunger.
Danish: Du må ikke trække i stemplet.
English: In patients who are stably attack free on treatment, a dose reduction of 300 mg lanadelumab every 4 weeks may be considered, especially in patients with low weight.
Danish: Til patienter, som er stabile og ikke har nogen anfald, når de er under behandling, kan en dosisnedsættelse til 300 mg lanadelumab hver 4. uge overvejes, især hos patienter med lav kropsvægt.
English: Tell your doctor, pharmacist or nurse if you take too much TAKHZYRO.
Danish: Fortæl det til lægen, apotekspersonalet eller sundhedspersonalet, hvis du har brugt for meget TAKHZYRO.
English: No dedicated drug-drug interaction studies have been conducted.
Danish: Der er ikke udført interaktionsstudier.
English: Be sure that you read, understand and follow the step-by-step instructions for injecting TAKHZYRO.
Danish: Det er vigtigt, at du har læst og forstået følgende trinvise anvisninger, og at du følger dem i forbindelse med injektion af TAKHZYRO.
English: TAKHZYRO is not known to affect other medicines or be affected by other medicines.
Danish: Så vidt vides påvirker TAKHZYRO ikke anden medicin og bliver ikke påvirket af anden medicin.
English: Lanadelumab provides sustained control of plasma kallikrein activity and thereby limits bradykinin generation in patients with HAE.
Danish: Lanadelumab giver vedvarende kontrol af plasmakallikrein-aktiviteten og begrænser dermed genereringen af bradykinin hos patienter med hereditært angioødem.
English: The mean reduction in HAE attack rate was consistently higher across the TAKHZYRO treatment arms compared to placebo regardless of the baseline history of LTP, laryngeal attacks, or attack rate during the run-in period.
Danish: Gennemsnitsreduktionen af HAE-anfaldshyppigheden var konstant højere i TAKHZYRObehandlingsgrupperne sammenlignet med placebo, uanset baseline-anamnesen for LTP, larynxanfald eller anfaldshyppighed i indkøringsperioden.
English: 4.4 Special warnings and precautions for use
Danish: 4.4 Særlige advarsler og forsigtighedsregler vedrørende brugen Sporbarhed
English: This medicinal product contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially 'sodium-free'.
Danish: Denne medicin indeholder mindre end 1 mmol (23 mg) natrium pr. hætteglas, dvs. den er i det væsentlige natriumfri.
English: Contact your doctor, pharmacist or nurse if you have any questions.
Danish: Kontakt lægen, apotekspersonalet eller sundhedspersonalet, hvis du har spørgsmål.
English: In the HELP study, patients treated with 300 mg q2 wks presented mean (SD) area under the curve over the dosing interval at steady-state (AUCtau,ss), maximum concentration at steady-state (Cmax,ss) and minimum concentration at steady-state (Cmin,ss) of 408 µg*day/ml (138), 34.4 µg/mL (11.2), and 25.4 µg/mL (9.18), respectively.
Danish: I HELP-studiet udviste de patienter, der blev behandlet med 300 mg hver 2. uge, et gennemsnitligt (SD) areal under kurven over doseringsintervallet ved steady state (AUCtau,ss), en maksimumskoncentration ved steady state (Cmax,ss) og en minimumskoncentration ved steady state (Cmin,ss) på henholdsvis 408 µg*dag/ml (138), 34,4 µg/ml (11,2) og 25,4 µg/ml (9,18).
English: TAKHZYRO has negligible influence on the ability to drive or use machines.
Danish: TAKHZYRO påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: Important: Inject TAKHZYRO within 2 hours of preparing the dosing syringe at room temperature.
Danish: Vigtigt: Injicer TAKHZYRO inden for 2 timer efter forberedelse af doseringssprøjten ved stuetemperatur.
English: Multipack: 2 vials (2 packs of 1 vial) of 2 ml.
Danish: Multipakning: 2 hætteglas (2 pakker med 1 hætteglas) på 2 ml.
English: • If you have a severe allergic reaction to TAKHZYRO with symptoms such as a rash, a tight chest,
Danish: Hvis du får en alvorlig allergisk reaktion over for TAKHZYRO med symptomer som udslæt,
English: In a 13-week study, once weekly SC administration of lanadelumab had no effects on male or female fertility at doses of 10 or 50 mg/kg (highest dose tested).
Danish: I et 13-ugers studie havde subkutan administration af lanadelumab én gang om ugen ingen virkning på fertiliteten hos hanner eller hunner ved doser på 10 eller 50 mg/kg (højeste afprøvede dosis).
English: Only use the syringes, blunt-tip vial access needles and pointed-tip injection needles in this pack or which your doctor has prescribed.
Danish: Anvend kun de sprøjter, overførselskanyler med stump spids og injektionskanyler med skarp spids, der findes i pakningen, eller som din læge har ordineret.
English: This medicinal product should be initiated under the supervision of a physician experienced in the management of patients with hereditary angioedema (HAE).
Danish: Behandling med dette lægemiddel må kun påbegyndes under tilsyn af en læge, der har erfaring i at behandle patienter med hereditært angioødem (HAE).
English: In repeat-dose studies evaluating once weekly SC injection in both rats (up to 28 days) and cynomolgus monkeys (up to 6 months) lanadelumab was well-tolerated at doses of up to and including 50 mg/kg (highest dose tested) with no organs of toxicity identified.
Danish: I studier med gentagne doser til evaluering af subkutan injektion en gang om ugen hos både rotter (op til 28 dage) og cynomolgusaber (op til 6 måneder) var lanadelumab veltolereret ved doser på op til 50 mg/kg (højeste afprøvede dosis) uden påvist organtoksicitet.
English: The percentage of patients who achieved a clinically meaningful improvement in AE-QoL total score was 65% (Odds ratio vs placebo, [95% CI]= 3.2 [1.1, 9.2]), 63% (2.9 [1.1, 8.1]), and 81% (7.2 [2.2, 23.4]), in TAKHZYRO 150 mg q4 wks, 300 mg q4 wks, and 300 mg q2 wks groups, respectively, compared to 37% of patients in the placebo group.
Danish: Procentdelen af patienter, der opnåede en klinisk betydningsfuld forbedring i den samlede AE-QoL-score var henholdsvis 65 % (odds-ratio vs. placebo, [95 % CI]= 3,2 [1,1, 9,2]), 63 % (2,9 [1,1, 8,1]) og 81 % (7,2 [2,2, 23,4]), i TAKHZYRO-grupperne med 150 mg hver 4. uge, 300 mg hver 4. uge og 300 mg hver 2. uge sammenlignet med 37 % af patienterne i placebogruppen.
English: HELP study
Danish: HELP-studiet
English: The medicine contains less than 1 mmol sodium (23 mg) per ml of solution, that is to say essentially ‘sodium-free'.
Danish: Dette lægemiddel indeholder mindre end 1 mmol (23 mg) natrium pr. ml opløsning, dvs. det er i det væsentlige natrium-frit.
English: Your treatment will be started and managed under the supervision of a doctor experienced in the care of patients with HAE.
Danish: Din behandling bliver påbegyndt og ledet under tilsyn af en læge, der har erfaring med at behandle patienter med hereditært angioødem HAE.
English: Disodium phosphate dihydrate Citric acid monohydrate Histidine
Danish: Dinatriumphosphatdihydrat Citronsyremonohydrat Histidin
English: Step 4: Select and prepare injection site a) Choose an injection site on your stomach
Danish: Trin 4: Vælg og klargør injektionsstedet a) Vælg et injektionssted på maven (abdomen), låret eller overarmen.
English: HAE is a condition which runs in families.
Danish: HAE er en arvelig lidelse, hvilket betyder, at sygdommen findes i familien.
English: Renal impairment is not expected to affect exposure to lanadelumab or the safety profile.
Danish: Nedsat nyrefunktion forventes ikke at påvirke eksponeringen for lanadelumab eller sikkerhedsprofilen.
English: All needles and syringes should be disposed of in a sharps container.
Danish: Alle kanyler og sprøjter skal bortskaffes i en kanyleboks.
English: A total of 212 adult and adolescent subjects with symptomatic type I or II HAE received at least one dose of lanadelumab in this study, including 109 subjects who entered as rollover subjects from the HELP study and 103 new or non-rollover subjects (including 19 subjects from Phase1b study) who had an historical baseline attack rate of ≥1 attack per 12 weeks Subjects were allowed to initiate self-administration after receiving the first 2 doses from a health care professional in clinic and completing appropriate training.
Danish: I alt fik 212 voksne og unge forsøgspersoner med symptomatisk HAE af type I eller II mindst én dosis lanadelumab i dette studie, herunder 109 forsøgspersoner, der fortsatte fra det tidligere HELP-studie, og 103 nye forsøgspersoner (herunder 19 forsøgspersoner fra fase1b-studiet), der havde en anamnestisk anfaldshyppighed ved baseline på ≥ 1 anfald pr. 12 uger.
English: TAKHZYRO is presented as a clear, colourless to slightly yellow solution for injection in a glass vial.
Danish: TAKHZYRO er en klar, farveløs til svagt gul injektionsvæske, opløsning i et hætteglas.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Danish: NAVN OG ADRESSE PÅ INDEHAVEREN AFMARKEDSFØRINGSTILLADELSEN
English: b) Pull back the plunger to fill the syringe with air equal to the amount of solution in the vial.
Danish: b) Træk stemplet tilbage for at fylde sprøjten med den mængde luft, der svarer til mængden af opløsning i hætteglasset.
English: Secondary endpoint - Number of moderate or severe HAE attacks from Day 0 to 182 LS Mean (95% CI) monthly attack rate b
Danish: Sekundært endepunkt - Antallet af moderate eller svære HAE-anfald fra dag 0 til 182 LS-gennemsnitlig (95 % CI) månedlig anfaldshyppighed b
English: Step 3: Transfer TAKHZYRO into syringe and switch to the pointed-tip injection needle a) Insert the needle into the centre of the rubber stopper.
Danish: Trin 3: Overfør TAKHZYRO til sprøjten, og skift over til injektionskanylen med den skarpe spids a) Indfør kanylen i midten af gummiproppen.
English: It is strongly recommended that every time you have a dose of TAKHZYRO, you write down the name and batch number of the medicine.
Danish: Det anbefales på det kraftigste, at du skriver lægemidlets navn og batchnummer (lot) ned, hver gang du tager en dosis TAKHZYRO.
English: All TAKHZYRO treatment groups observed an improvement in Angioedema Quality of Life Questionnaire (AE-QoL) total and domain (functioning, fatigue/mood, fear/shame, and nutrition) scores compared to the placebo group; the largest improvement was observed in the functioning score as shown in Table 4.
Danish: Alle TAKHZYRO-behandlingsgrupper oplevede en forbedring i spørgeskemaet Angioedema Quality of Life Questionnaire (AE-QoL), både mht. den samlede score og domænescorer (funktion, træthed/humør, angst/skam og ernæring) sammenlignet med placebogruppen.
English: Do not remove the vial rubber stopper.
Danish: Fjern ikke hætteglassets gummiprop.
English: Concentration-dependent inhibition of plasma kallikrein, measured as reduction of cHMWK levels, was demonstrated after SC administration of TAKHZYRO 150 mg every 4 weeks, 300 mg every 4 weeks or 300 mg every 2 weeks in subjects with HAE.
Danish: Der blev påvist koncentrationsafhængig hæmning af plasmakallikrein, målt som reduktion i cHMWKniveauerne efter subkutan administration af TAKHZYRO 150 mg hver 4. uge, 300 mg hver 4. uge eller 300 mg hver 2. uge hos forsøgspersoner med hereditært angioødem.
English: • Reactions where the injection is given - symptoms include pain, skin redness, bruising, discomfort, swelling, bleeding, itching, hardening of skin, tingling, warmth and rash.
Danish: Reaktioner på injektionsstedet - symptomerne omfatter smerter, rødmen på huden, blå mærker, ubehag, hævelse, blødning, kløe, fortykkelse af huden, snurren, varme og udslæt.
English: Slowly push the plunger, allowing air to go back into the vial, until the solution reaches the top of the syringe.
Danish: Tryk langsomt stemplet ind, så der kommer luft ind i hætteglasset igen, indtil opløsningen når øverste del af sprøjten.
English: Pull back on the plunger to withdraw the full dose in the vial.
Danish: Træk stemplet tilbage, så den fulde dosis i hætteglasset trækkes op.
English: TAKHZYRO is not intended for treatment of acute HAE attacks (see section 4.4)
Danish: TAKHZYRO er ikke beregnet til behandling af akutte HAE-anfald (se pkt.
English: [moderate, N=9]) had no effect on the clearance or volume of distribution of lanadelumab.
Danish: [moderat, N=9]) i en populationsfarmakokinetisk analyse ingen indvirkning på lanadelumabs clearance eller fordelingsvolumen.
English: The effects of lanadelumab on fertility were evaluated in sexually mature cynomolgus monkeys.
Danish: Lanadelumabs virkning på fertilitet blev vurderet hos kønsmodne cynomolgusaber.
English: Injection site reactions**
Danish: Reaktioner på injektionsstedet** Meget almindelig
English: METHOD AND ROUTE(S) OF ADMINISTRATION
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Subkutan anvendelse
English: **Injection site reactions include: pain, erythema, bruising, discomfort, haematoma, haemorrhage, pruritus, swelling, induration, paraesthesia, reaction, warmth, oedema and rash.
Danish: **Reaktioner på injektionsstedet omfatter: smerte, erytem, blå mærker, ubehag, hæmatom, blødning, pruritus, hævelse, induration, paræstesi, reaktion, varme, ødem og udslæt.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER HÆTTEGLASMÆRKAT
English: TAKHZYRO is not recommended for use in children under 12 years of age.
Danish: Brug af TAKHZYRO til børn under 12 år frarådes.
English: Used for injection under the skin (subcutaneous).
Danish: Anvendes til injektion under huden (subkutan injektion).
English: Inhibition of plasma kallikrein by lanadelumab can increase aPTT in this assay.
Danish: Lanadelumabs hæmning af plasmakallikrein kan øge aPTT i denne analyse.
English: Step 5: Inject TAKHZYRO
Danish: Trin 5: Injicér TAKHZYRO
English: Solution for injection 1 vial of 2 ml
Danish: Injektionsvæske, opløsning 1 hætteglas med 2 ml
English: No studies have been conducted in patients with severe renal impairment.
Danish: Der er ikke udført studier med patienter med svært nedsat nyrefunktion.
English: Age is not expected to affect exposure to lanadelumab.
Danish: Alder forventes ikke at påvirke eksponeringen for lanadelumab.
English: The recommended starting dose is 300 mg lanadelumab every 2 weeks.
Danish: Den anbefalede startdosis er 300 mg lanadelumab hver 2. uge.
English: h) Place the vial on a flat surface.
Danish: h) Anbring hætteglasset på en plan overflade.