FrancophonIA/ELRC3.0 huggingface dataset:
English: Administration process for a dose of 1000 IU
Danish: Administrationsprocedure for en dosis på 1000 IE Anvend en aseptisk teknik under administrationsproceduren.
English: Date of first authorisation: 11 July 2008 Date of latest renewal: 13 March 2013
Danish: Dato for første markedsføringstilladelse: 11. juli 2008 Dato for seneste fornyelse: 13. marts 2013
English: All patients maintained efficacy.
Danish: Alle patienterne opretholdt virkningen.
English: An attack usually lasts between 2 to 5 days.
Danish: Et anfald varer normalt mellem 2 og 5 dage.
English: (Unknown)
Danish: (Ikke kendt)
English: The instructions include the following main steps:
Danish: Vejledningen omfatter følgende hovedtrin:
English: Limited information is available on patients older than 65 years of age.
Danish: Der findes begrænsede oplysninger vedrørende patienter, der er ældre end 65 år.
English: When and how often should you use Firazyr?
Danish: Hvornår og hvor ofte skal du bruge Firazyr?
English: Important information for healthcare professionals and caregivers:
Danish: Vigtige oplysninger til sundhedspersoner og omsorgspersoner:
English: • Press slowly so that this takes approximately 30 seconds.
Danish: • Du skal presse stemplet langsomt, således at det tager ca. 30 sekunder.
English: Difference between treatments (95% CI, p-value)
Danish: Forskel mellem behandlinger (95 % CI, p-værdi
English: The time to maximum concentration is approximately 30 minutes.
Danish: Tiden til den maksimale koncentration er ca. 30 minutter.
English: These symptoms may occur as a result of an attack of HAE.
Danish: Disse symptomer kan forekomme som et resultat af et HAE-anfald.
English: If there is air in the graduated syringe:
Danish: Hvis der er luft i den graduerede sprøjte:
English: Your doctor has determined the exact dose of Firazyr and will tell you how often it should be used.
Danish: Din læge har bestemt den præcise dosis af Firazyr og vil fortælle dig, hvor ofte den skal bruges.
English: Table 3 shows the efficacy results for these studies.
Danish: Tabel 3 viser effektresultaterne for disse studier.
English: Response rate (%, CI) at 4 hours after start of treatment
Danish: Responsrate (%, CI) 4 timer efter behandlingens begyndelse
English: 92.4% of these attacks of HAE were treated with a single dose of Firazyr.
Danish: 92,4 % af disse HAE-anfald blev behandlet med én dosis Firazyr.
English: The terminal plasma half-life is about 1-2 hours.
Danish: Den terminale halveringstid i plasma er ca. 1-2 timer.
English: D02 Y754, Ireland
Danish: D02 Y754, Irland
English: System Organ Class (incidence category)
Danish: Systemorganklasse (hændelseskategori)
English: Available exposure data suggest no difference in the clearance between non-White (n=40) and White (n=132) subjects.
Danish: Tilgængelige data for eksponering tyder ikke på nogen forskel i clearance mellem ikke-hvide (n = 40) og hvide (n = 132) forsøgspersoner.
English: In the majority of cases a single injection of Firazyr is sufficient to treat an attack.
Danish: I de fleste tilfælde er en enkelt injektion af Firazyr nok til at behandle et anfald.
English: Data suggest that there is no difference in the clearance between females and males after correcting for body weight.
Danish: Data tyder på, at der ikke er nogen forskel i clearance mellem kvinder og mænd efter korrektion for legemsvægt.
English: • The syringe is now ready for injection.
Danish: • Sprøjten er nu klar til injektionen.
English: • Clean the work area (surface) to be used before beginning the process.
Danish: • Rengør det arbejdsområde (den arbejdsflade), der skal anvendes, inden du starter.
English: Clearance is about 15-20 l/h and independent of dose.
Danish: Clearance er på ca. 15-20 l/t og er uafhængig af dosis.
English: There are no data on administering subsequent doses for the same attack in adolescents or children.
Danish: Der foreligger ingen data om administration af flere doser til behandling af det samme anfald hos børn og unge.
English: It is a synthetic decapeptide with a structure similar to bradykinin, but with 5 non-proteinogenic amino acids.
Danish: Det er et syntetisk decapeptid med en struktur, der ligner bradykinin, men med 5 ikke-proteinogene aminosyrer.
English: These tissue findings were consistent with reported effects on gonadotrophins and during the subsequent treatment-free period appear to be reversible.
Danish: Disse vævsreaktioner var i overensstemmelse med de rapporterede virkninger på gonadotropiner og synes at være reversible i den efterfølgende behandlingsfri periode.
English: HAE (an autosomal dominant disease) is caused by an absence or dysfunction of C1-esteraseinhibitor.
Danish: HAE (en autosomal, dominant sygdom) skyldes fravær eller dysfunktion af C1-esterasehæmmer.
English: - If you are allergic to icatibant, or any of the other ingredients of this medicine (listed in section 6).
Danish: - hvis du er allergisk over for icatibant eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i punkt 6).
English: Data suggest an age-related decline in clearance resulting in about 50-60% higher exposure in older people (75-80 years) compared to patients aged 40 years.
Danish: Dataene tyder på en aldersrelateret reduktion i clearance, som medfører en ca. 50-60 % højere eksponering hos ældre (75-80 år) i forhold til patienter på 40 år.
English: Two paediatric patients experienced injection site reactions which were assessed as severe and which were completely resolved within 6 hours.
Danish: To pædiatriske patienter oplevede reaktioner på injektionsstedet, som blev bedømt som svære, og som forsvandt fuldstændigt inden for 6 timer.
English: Eleven patients were of prepubertal status and 21 patients were either pubertal or postpubertal.
Danish: 11 patienter var præpubertære, og 21 patienter var enten pubertære eller postpubertære.
English: No clinically significant changes in reproductive hormones were observed during clinical studies.
Danish: Der blev ikke observeret klinisk signifikante forandringer i reproduktionshormoner i de kliniske studier.
English: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000).
Danish: Meget almindelig (≥1/10), almindelig (≥1/100 til <1/10), ikke almindelig (≥1/1.000 til <1/100), sjælden (≥1/10.000 til <1/1.000), meget sjælden (<1/10.000).
English: Laryngeal attacks
Danish: Laryngeale anfald
English: Following subcutaneous administration, the absolute bioavailability of icatibant is 97%.
Danish: Efter subkutan indgift var den absolutte biologiske tilgængelighed for icatibant 97 %.
English: Pharmacokinetic drug interactions involving CYP450 are not expected (see section 5.2).
Danish: Det forventes ikke, at der er farmakokinetiske lægemiddelinteraktioner, der involverer CYP450 (se afsnit 5.2).
English: There are no observed differences in the exposure to icatibant between HAE patients with and without an attack.
Danish: Der er ikke observeret nogen forskelle i eksponeringen for icatibant mellem HAE-patienter med og uden et anfald.
English: - You should not have more than 3 injections in a 24 hour period and if you require more than 8 injections in a month, you should seek medical advice.
Danish: Du må ikke få mere end 3 indsprøjtninger i løbet af et døgn, og hvis du har brug for mere end 8 indsprøjtninger på en måned, skal du søge lægehjælp.
English: Efficacy results for FAST-1 and FAST-2
Danish: Effektresultater for FAST-1 og FAST-2
English: Children and adolescents aged 2 to 17 years
Danish: Børn og unge i alderen 2-17 år
English: Icatibant volume of distribution (Vss) is about 20-25 L. Plasma protein binding is 44%.
Danish: Volumendistributionen (Vss) for icatibant er ca. 20-25 L. Plasmaproteinbindingen er 44 %.
English: Results do not indicate a carcinogenic potential for icatibant.
Danish: Resultaterne indikerer ikke et kræftfremkaldende potentiale hos icatibant.
English: No clinical information on overdose is available.
Danish: Der findes ingen kliniske oplysninger om overdosering.
English: Firazyr contains a small amount of sodium
Danish: Firazyr indeholder en lille mængde natrium
English: No therapeutic intervention was necessary.
Danish: Behandling var ikke nødvendig.
English: Firazyr has minor influence on the ability to drive and use machines.
Danish: Firazyr påvirker i mindre grad evnen til at føre motorkøretøj og betjene maskiner.
English: Repeated-dose studies of up to 6-months duration in rats and 9-months duration in dogs have been conducted.
Danish: Der er gennemført studier med gentagen dosis af indtil 6 måneders varighed hos rotter og af 9 måneders varighed hos hunde.
English: Table 4 shows the efficacy results for FAST-3.
Danish: Tabel 4 viser effektresultaterne for FAST-3.
English: Not known (frequency cannot be estimated from the available data) : Hives (urticaria)
Danish: Ikke kendt (kan ikke estimeres ud fra forhåndenværende data): Nældefeber (urticaria)
English: Patients should be advised not to drive and use machines if they feel tired or dizzy.
Danish: Patienterne skal frarådes at føre motorkøretøj og betjene maskiner, hvis de føler sig trætte eller svimle.
English: These reactions were erythema, swelling, burning and warm sensation.
Danish: Disse reaktioner var erytem og hævelse samt en brændende og varm fornemmelse.
English: Very common (may affect more than 1 in 10 people) :
Danish: Meget almindelige (forekommer hos mere end 1 ud af 10 behandlede):
English: Each syringe should only be used once.
Danish: Sprøjten må kun bruges en gang.
English: A total of 237 patients were treated with 1,386 doses of 30 mg icatibant for 1,278 attacks of acute HAE.
Danish: I alt 237 patienter blev behandlet med 1.386 doser a 30 mg icatibant for 1.278 akutte HAE-anfald.
English: The dosing regimen used for this study is unlikely to be sustained in the clinical setting.
Danish: Det er usandsynligt, at det dosisregimen, der blev anvendt i dette studie, bibeholdes i klinisk praksis.
English: It is unknown whether icatibant is excreted in human breast milk but it is recommended that breastfeeding women, who wish to take Firazyr, should not breastfeed for 12 hours after treatment.
Danish: Det vides ikke, om icatibant udskilles i human mælk, men det anbefales, at ammende kvinder, der tager Firazyr, ikke ammer i 12 timer efter indgiften.
English: Controlled Clinical Study of FIRAZYR vs Tranexamic acid or Placebo: Efficacy Results FAST-2
Danish: Kontrolleret klinisk studie af FIRAZYR versus tranexamsyre/placebo: Effektresultater FAST-2
English: The frequency of adverse reactions listed in Table 1 is defined using the following convention:
Danish: Hyppigheden af bivirkninger, der ses i tabel 1, angives i henhold til følgende klassifikationer:
English: Do not use this medicine if you notice that the syringe or needle packaging is damaged or if there are any visible signs of deterioration, for example if the solution is cloudy, if it has floating particles, or if the colour of the solution has changed.
Danish: Brug ikke dette lægemiddel, hvis du bemærker, at pakken med sprøjten eller kanylen er beskadiget, eller hvis der ses tydelige tegn på nedbrydning, for eksempel hvis væsken er uklar, indeholder partikler, eller hvis dens farve er ændret.
English: No effects were detected in the post-natal development of rat pups.
Danish: Der er ikke observeret påvirkning af rotteungernes postnatale udvikling.
English: Firazyr is not recommended for use in children under 2 years of age or weighing less than 12 kg because it has not been studied in these patients.
Danish: Firazyr anbefales ikke til børn under 2 år eller med en vægt på under 12 kg, da det ikke er undersøgt hos disse patienter.
English: Elderly people have been shown to have increased systemic exposure to icatibant.
Danish: Det er vist, at ældre har en øget systemisk eksponering for icatibant.
English: Subsequent episodes of HAE were treated in an open label extension.
Danish: Efterfølgende HAE-anfald blev behandlet i et efterfølgende åbent studie.
English: FAST-3 was a randomized, placebo-controlled, parallel-group study of 98 adult patients with a median age of 36 years.
Danish: FAST-3 var et randomiseret, placebo-kontrolleret, parallelgruppestudie med 98 voksne patienter med en medianalder på 36 år.
English: Icatibant is a selective competitive antagonist at the bradykinin type 2 (B2) receptor.
Danish: Icatibant er en selektiv, kompetitiv antagonist til bradykinin-receptortype 2 (B2).
English: If you are taking a medicine known as an Angiotensin Converting Enzyme (ACE) inhibitor (for example: captopril, enalapril, ramipril, quinapril, lisinopril) which is used to lower your blood pressure or for any other reason, you should inform your doctor before receiving Firazyr.
Danish: Hvis du tager medicin, som kaldes ACEhæmmer (for eksempel: captopril, enalapril, ramipril, quinapril, lisinopril) for at sænke blodtrykket eller af andre grunde, skal du fortælle din læge det, inden du får Firazyr.
English: Where the required dose is less than 30 mg (3 ml), the following equipment is required to extract and administer the appropriate dose:
Danish: Hvis den ønskede dosis er mindre end 30 mg (3 ml), er det følgende udstyr nødvendigt for at ekstrahere og indgive den relevante dosis:
English: • Adapter (proximal and/or distal female luer lock connector/coupler)
Danish: a) Adapter (proksimal og/eller distal hun-luer-lock-konnektor/kobling)
English: A total of 32 paediatric patients (8 children aged 2 to 11 years and 24 adolescents aged 12 to 17 years) with HAE were exposed to treatment with icatibant during clinical studies.
Danish: I alt 32 pædiatriske patienter (8 børn i alderen 2-11 år og 24 unge i alderen 12-17 år) med HAE blev eksponeret for behandling med icatibant i løbet af de kliniske studier.
English: The relevance of this to the safety of Firazyr is unknown (see section 5.2).
Danish: Relevansen af dette for sikkerheden i forbindelse med Firazyr er ikke kendt (se pkt.
English: A total of 66 patients with attacks of HAE affecting the larynx were treated in these controlled Phase III clinical trials.
Danish: I alt blev 66 patienter med HAE-anfald, der involverede larynx, behandlet i disse kontrollerede kliniske fase III-studier.
English: 1) Remove the caps on each end of the connector.
Danish: 1) Fjern hætterne i hver ende af konnektoren.
English: The injection solution contains less than 1 mmol (23 milligrams) of sodium, so it is essentially ‘sodium-free'.
Danish: Injektionsvæsken indeholder mindre end 1 mmol (23 milligram) natrium, så den er praktisk taget ‘natriumfri'.
English: Adults The recommended dose for adults is a single subcutaneous injection of Firazyr 30 mg.
Danish: Voksne Den anbefalede dosis til voksne er én subkutan injektion af Firazyr 30 mg.
English: The treatment effect of icatibant was confirmed by secondary efficacy endpoints.
Danish: Icatibants behandlingseffekt blev bekræftet af sekundære effektmål.
English: Efficacy data were obtained from an initial open-label Phase II study and from three controlled Phase III studies.
Danish: Klinisk virkning og sikkerhed Virkningsdata opnåedes fra et åbent fase II-studie og fra tre kontrollerede fase III-studier.
English: At 1 and 2 hours post treatment, approximately 50% and 90% of patients experienced onset of symptom relief, respectively.
Danish: Ved henholdsvis 1 og 2 timer efter behandling oplevede ca. 50 % og 90 % debut af symptomlindring.
English: • Clean the injection site with a rubbing alcohol pad and allow it to dry.
Danish: • Rens injektionsstedet med en spritserviet og lad det tørre.
English: Following a single subcutaneous administration (0.4 mg/kg up to a maximum of 30 mg), the time to maximum concentration is approximately 30 minutes and the terminal half-life is about 2 hours.
Danish: Efter en enkelt subkutan administration (0,4 mg/kg op til maksimalt 30 mg) er tiden til maksimal koncentration ca. 30 minutter, og den terminale halveringstid er ca. 2 timer.
English: In vitro studies have confirmed that icatibant is not degraded by oxidative metabolic pathways and is not an inhibitor of major cytochrome P450 (CYP) isoenzymes (CYP 1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1, and 3A4) and is not an inducer of CYP 1A2 and 3A4.
Danish: In vitro-studier har bekræftet, at icatibant ikke nedbrydes af den oxidative metabolisme, at det ikke hæmmer store cytochrom P450 (CYP) isoenzymer (CYP 1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1 og 3A4), og at det ikke inducerer CYP 1A2 og 3A4.
English: 3) Attach the graduated syringe to the other end of the connector ensuring that both connections fit securely.
Danish: 3) Tilslut den graduerede sprøjte til den anden ende af konnektoren, og sørg for, at begge forbindelser slutter tæt.
English: - If your symptoms get worse or do not improve, you must seek immediate medical help.
Danish: - Hvis dine symptomer bliver værre, eller hvis du ikke oplever en bedring, skal du straks søge lægehjælp.
English: Although there is evidence to support a beneficial effect of B2 receptor blockade immediately following a stroke, there is a theoretical possibility that icatibant may attenuate the positive late phase neuroprotective effects of bradykinin.
Danish: Selvom der findes beviser, der tyder på, at en B2-receptorblokade umiddelbart efter et apopleksitilfælde har en gavnlig indflydelse, er der en teoretisk mulighed for, at icatibant i den sene fase kan svække bradykinins neuroprotektive virkning.
English: • Hold syringe between 45-90 degrees angle to skin with needle facing the skin.
Danish: • Hold sprøjten i en 45-90 graders vinkel på huden med kanylen ind mod huden.
English: Patients weighing more than 65 kg will use the full contents of the pre-filled syringe (3 ml).
Danish: Patienter, der vejer mere end 65 kg, skal bruge hele indholdet af den fyldte injektionssprøjte (3 ml).
English: Firazyr solution for injection should be injected slowly due to the volume to be administered.
Danish: Firazyr-injektionsvæsken skal injiceres langsomt på grund af den mængde, der skal indgives.
English: One Firazyr-treated patient tested positive for anti-icatibant antibodies before and after treatment with Firazyr.
Danish: Én Firazyr-behandlet patient blev testet positiv for anti-icatibant-antistoffer før og efter behandling med Firazyr.
English: Firazyr should be used during pregnancy only, if the potential benefit justifies the potential risk for the foetus, (e.g for treatment of potentially life threatening laryngeal attacks).
Danish: Firazyr bør kun anvendes til gravide, hvis de potentielle gavnlige virkninger retfærdiggør den potentielle risiko for fostret (for eksempel til potentielt livstruende laryngeale anfald).
English: Dose (Injection Volume)
Danish: Dosis (injektionsvolumen)
English: Table 1: Dosage regimen for paediatric patients Body Weight
Danish: Tabel 1: Doseringsregimen for pædiatriske patienter Legemsvægt
English: There is limited experience with treatment of more than one HAE attack with Firazyr in the paediatric population.
Danish: Der er begrænset erfaring med Firazyr-behandling af mere end ét HAE-anfald hos den pædiatriske population.
English: These reactions were generally mild to moderate in severity, transient, and resolved without further intervention.
Danish: Disse reaktioner var som regel lette til moderate og forbigående og forsvandt uden yderligere intervention.
English: The required injection volume in ml should be drawn up in an empty 3 ml graduated syringe (see table below).
Danish: Den ønskede injektionsvolumen i ml bør trækkes op i en tom gradueret 3 ml-sprøjte (se tabellen nedenfor).
English: Some of the side effects connected with Firazyr are similar to the symptoms of your disease.
Danish: Bivirkningerne forbundet med Firazyr minder om dine sygdomssymptomer.
English: Caution should therefore be observed in the administration of Firazyr to patients with acute ischemic heart disease or unstable angina pectoris (see section 5.3).
Danish: Der skal derfor udvises forsigtighed, når der indgives Firazyr til patienter med akut iskæmisk hjertesygdom eller med ustabil angina pectoris (se afsnit 5.3).
English: • 3 ml (recommended) graduated syringe
Danish: b) 3 ml (anbefalet) gradueret sprøjte
English: Table 1: Dosage regimen for children and adolescents Body Weight
Danish: Tabel 1: Doseringsregimen for børn og unge Legemsvægt
English: Firazyr 30 mg SC has been administered by a healthcare professional to 129 healthy subjects and 236 patients with HAE.
Danish: Firazyr 30 mg blev administreret s.c. af en sundhedsperson til 129 raske forsøgspersoner og 236 patienter med HAE.
English: Information on individual race effect is limited.
Danish: Der er begrænsede oplysninger om indvirkningen af etnisk oprindelse.
English: 2b) Preparing the syringe and needle for injection: All patients (adults, adolescents and children)
Danish: 2b) Klargøring af sprøjten og kanylen til injektion: Alle patienter (børn, unge og voksne)
English: If you are breast-feeding you should not breast-feed for 12 hours after you have last received Firazyr.
Danish: Hvis du ammer, må du ikke amme i 12 timer, efter at du sidst har taget Firazyr.
English: Icatibant is excreted in the milk of lactating rats at concentrations similar to those in maternal blood.
Danish: Icatibant udskilles i mælken hos diegivende rotter i koncentrationer, der svarer til koncentrationen i moderens blod.
English: No hypersensitivity or anaphylactic reactions were reported with Firazyr.
Danish: Der blev ikke rapporteret overfølsomhed eller anafylaktiske reaktioner over for Firazyr.
English: A 2-week subcutaneous dose range finding study in juvenile rats identified 25 mg/kg/day as a maximally tolerated dose.
Danish: En 2-ugers subkutan dosisområde-undersøgelse hos unge rotter identificerede 25 mg/kg/dag som en maksimalt tolereret dosis.
English: Do not use this medicine after the expiry date stated on the label after ‘EXP'.
Danish: Brug ikke dette lægemiddel efter den udløbsdato, der står på pakningen.
English: Phase III clinical studies (FAST-1 and FAST-2) were randomized, double-blind, controlled trials and had identical designs except for the comparator (one with oral tranexamic acid as the comparator and one placebo controlled).
Danish: Kliniske fase III-studier (FAST-1 og FAST-2) var randomiserede, dobbeltblindede, kontrollerede studier med identisk design bortset fra komparator (en med oral tranexaminsyre som komparator og en placebokontrolleret).
English: The following step-by step instructions are intended for: - self-administration (adults) - administration by a caregiver or healthcare professional to adults, adolescents or children aged over 2 years (weighing at least 12 kg).
Danish: Følgende trin-for-trin-vejledning er udelukkende beregnet til: - Brug i forbindelse med selvmedicinering (voksne) - Administration ved en omsorgsperson eller en sundhedsperson til voksne, unge eller børn i alderen over 2 år (med en legemsvægt på mindst 12 kg).
English: Icatibant has been shown to aggravate induced cardiac ischemia in several non-clinical models, although a detrimental effect has not consistently been shown in acute ischemia.
Danish: Icatibant har vist sig at forværre induceret iskæmi i hjertet i flere ikke-kliniske modeller, selvom en skadelig effekt ikke altid er påvist ved akut iskæmi.
English: This patient was followed for 5 months and further samples were negative for anti-icatibant antibodies.
Danish: Denne patient blev fulgt i 5 måneder, og efterfølgende prøver var negative for anti-icatibant-antistoffer.
English: In clinical studies used for registration, a total of 999 HAE attacks have been treated with 30 mg Firazyr administered subcutaneously by a healthcare professional.
Danish: I kliniske studier udført i godkendelsesøjemed blev i alt 999 HAE-anfald behandlet med 30 mg Firazyr administreret subkutant af en sundhedsperson.
English: In the clinical trials, not more than 8 injections of Firazyr per month have been administered.
Danish: I de kliniske studier blev der ikke indgivet mere end 8 injektioner af Firazyr om måneden.