FrancophonIA/ELRC3.0 huggingface dataset:
English: Dyslipidemia is common with elevated LDL and triglycerides and low HDL, associated with increase liver fat content and transaminase elevations.
Danish: Dyslipidæmi er almindelig med forhøjet LDL og forhøjede triglycerider og lavt HDL i forbindelse med øget leverfedtindhold og aminotransferaseforhøjelser.
English: Each 10 ml vial contains 33 mg sodium.
Danish: Hvert 10 ml hætteglas indeholder 33 mg natrium.
English: Each vial contains 33 mg sodium.
Danish: Hvert hætteglas indeholder 33 mg natrium.
English: Infusion related reaction c a Common = Reported in ≥ 1 patient receiving KANUMA b Reported at the same frequency in patients receiving KANUMA or placebo or more frequently in patients receiving placebo during the double-blind period of LAL-CL02
Danish: Indberettet lige hyppigt for patienter, der fik KANUMA og placebo, eller hyppigere for patienter, der fik placebo, under den dobbeltblinde del af LAL-CL02
English: KANUMA 2 mg/ml concentrate for solution for infusion sebelipase alfa
Danish: KANUMA 2 mg/ml koncentrat til infusionsvæske, opløsning sebelipase alfa
English: Signs and symptoms included chest discomfort, conjunctival injection, dyspnoea, generalised and itchy rash, hyperaemia, mild eyelid oedema, rhinorrhoea, severe respiratory distress, tachycardia, tachypnoea and urticaria.
Danish: Tegn og symptomer omfattede ubehag i brystet, konjunktival injektion, dyspnø, generaliseret og kløende udslæt, hyperæmi, let øjenlågsødem, rinoré, udtalt vejrtrækningsbesvær, takykardi, takypnø og urticaria.
English: Each vial of 10 ml contains 20 mg sebelipase alfa.
Danish: Hvert hætteglas med 10 ml indeholder 20 mg sebelipase alfa.
English: Very common Tachycardia b
Danish: Takykardi b
English: Transient hyperlipidaemia
Danish: Forbigående hyperlipidæmi
English: Life-threatening hypersensitivity (anaphylactic reaction) to the active substance when attempts to rechallenge are unsuccessful, or to egg or any of the excipients listed in section 6.1, (see section 4.4).
Danish: Livstruende overfølsomhed (anafylaktisk reaktion) over for det aktive stof, når forsøg på gentagen provokation (rechallenge) ikke lykkes, eller over for æg eller et eller flere af hjælpestofferne anført i pkt.
English: It is a solution that is clear to slightly opalescent, and colourless to slightly coloured.
Danish: Opløsningen er klar til svagt opaliserende og farveløs til svagt farvet.
English: KANUMA 2 mg/ml concentrate for solution for infusion
Danish: KANUMA 2 mg/ml koncentrat til infusionsvæske, opløsning
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 20 mg sebelipase alfa in 10 ml of solution (2 mg/ml)
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hvert hætteglas indeholder 20 mg sebelipase alfa i 10 ml koncentrat (2 mg/ml)
English: Obligation to conduct post-authorisation measures The MAH shall complete, the measures described below:
Danish: Indehaveren af markedsføringstilladelsen skal inden for den fastsatte tidsramme gennemføre følgende foranstaltninger:
English: ≥ 18 years old N=18 Week 0 Week 22* Week 0 Week 22* Week 0 Week 22* AUCss (ng∙hr/mL) 1133.8 941.6 1436.4 1453.6 1989.3 1861.0 Cmax (ng/mL) Tmax (hr) CL (L/hr) Vc (L) T1/2 (hr) * Week 22 for placebo patients reset to Week 0, i.e. first week of active treatment.
Danish: AUCss (ng∙t/ml) Cmax (ng/ml) Tmax (t) CL (l/t) Vc (l) T1/2 (t) * Uge 22 for placebo-patienter er nulstillet til uge 0, dvs. første uge med aktiv behandling.
English: Body temperature increased, oxygen saturation decreased, blood pressure increased, heart rate increased, respiratory rate increased a
Danish: Forhøjet kropstemperatur, nedsat iltmætning, forhøjet blodtryk, øget hjertefrekvens, hurtigere vejrtrækning a Meget almindelig = Indberettet for ≥ 1 patient, der fik KANUMA
English: How KANUMA works
Danish: Sådan virker KANUMA
English: Very common Hypertension, pallor b
Danish: Hypertension, bleghed b
English: Very common = Reported in ≥ 1 patient receiving KANUMA
Danish: Almindelig Infusionsrelateret reaktionc a Almindelig = Indberettet for ≥ 1 patient, der fik KANUMA
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Danish: Inden for de enkelte frekvensgrupperinger er de alvorligste bivirkninger angivet først.
English: For management of adverse reactions, see sections 4.4 and 4.8.
Danish: 4.4 og 4.8.
English: Infants presenting with LAL deficiency
Danish: Spædbørn med LAL-mangel
English: Anaphylactic reaction, eyelid oedema
Danish: Almindelig Anafylaktisk reaktion, øjenlågsødem
English: IV use after dilution
Danish: I.v.-anvendelse efter fortynding.
English: For diluted solutions, immediate use is recommended.
Danish: Det anbefales, at den fortyndede infusionsvæske anvendes straks.
English: The most serious side effects may include an allergic reaction (seen very commonly [may affect more than 1 in 10 people] in infants younger than 6 months old, or commonly [may affect up to 1 in 10 people] in children and adults) with symptoms including difficulty breathing, swelling of the throat, rapid breathing, fast heartbeat, chest discomfort, mild swelling of eyelids, red eyes, runny nose, flushing, and hives.
Danish: De alvorligste bivirkninger kan omfatte en allergisk reaktion (meget almindelig [kan forekomme hos flere end 1 ud af 10 personer] hos spædbørn under 6 måneder, eller almindelig [kan forekomme hos op til 1 ud af 10 personer] hos børn og voksne).
English: Urticaria, rashc,e (including rash papular and rash pruritic), prurituse, eczema e
Danish: (herunder papuløst og kløende udslæt), pruritus e, eksem e
English: Triglycerides, mean % change from baseline HDL-cholesterol, mean % change from baseline Liver fat content c, mean % change from baseline a Proportion of patients who achieved normalisation defined as 34 or 43 U/l, depending on age and gender.
Danish: Triglycerider, middel % ændring fra baseline HDL-kolesterol, middel % ændring fra baseline Leverfedtindhold c, middel % ændring fra baseline a
English: Respiratory, thoracic and mediastinal disorders
Danish: Luftveje, thorax og mediastinum Meget almindelig
English: Very common Diarrhoea, gastro-oesophageal reflux disease, retching, vomiting b
Danish: Diarré, gastroøsofageal reflukssygdom, kløgning, opkastningb
English: Laryngeal oedema e, dyspnoea b,c,e
Danish: Almindelig Urticaria, udslæt c,e
English: Menorrhagia
Danish: ødem
English: Very common Hypotonia
Danish: Almindelig Svimmelhed
English: , oedema, fatigue, infusion site induration, pyrexia
Danish: Kulderystelser, ubehag i brystet c,e ødem, træthed, induration på infusionsstedet, pyreksi
English: No dosing adjustment is recommended in patients with renal or hepatic impairment based on current knowledge of the pharmacokinetics and pharmacodynamics of sebelipase alfa.
Danish: Baseret på den aktuelle viden om sebelipase alfas farmakokinetik og farmakodynamik anbefales dosisjustering ikke hos patienter med nedsat nyre- eller leverfunktion, se pkt.
English: Tachycardia
Danish: Hyppigheda
English: Very common Agitation b, irritability b
Danish: Agitationb, irritabilitetb
English: Replacement of
Danish: Opbevaring
English: How KANUMA is given
Danish: Sådan vil du få KANUMA
English: ANNEX II A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Danish: BILAG II A. FREMSTILLER AF DET BIOLOGISK AKTIVE STOF OG FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE B. BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING OG ANVENDELSE C. ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN D. BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET
English: Reported in ≥ 2 patients receiving KANUMA c Age at first dose: 1 to 6 months
Danish: Alder ved første dosis: 1 til 6 måneder Tabel 2: Bivirkninger indberettet for børn og voksne d, der fik KANUMA
English: What KANUMA looks like and contents of the pack KANUMA is supplied as a concentrate for solution for infusion.
Danish: KANUMA udleveres som et koncentrat til infusionsvæske, opløsning.
English: Aseptic technique should be used.
Danish: KANUMA skal klargøres og anvendes i henhold til nedenstående trin. Der skal anvendes aseptisk teknik.
English: It is not known whether sebelipase alfa passes into breast milk; therefore it is recommended that you stop breast-feeding or using KANUMA treatment while breast-feeding.
Danish: Det anbefales derfor, at du holder op med at amme eller med at få KANUMA, så længe du ammer.
English: Reproductive system and breast disorders
Danish: Det reproduktive system og mammae Almindelig Menoragi Almene symptomer og reaktioner på administrationsstedet
English: What KANUMA is and what it is used for What you need to know before you are given KANUMA How KANUMA is given
Danish: Det skal du vide, før du begynder at få KANUMA Sådan vil du få KANUMA Bivirkninger
English: How to store KANUMA
Danish: Mave-tarm-kanalen
English: Date of latest renewal: 16 May 2018.
Danish: Dato for seneste fornyelse: 16. maj 2018.
English: Your doctor will decide how much medicine you will take and how often.
Danish: Din læge afgør, hvor meget medicin, du skal tage, og hvor ofte.
English: All strengths listed above contain the other ingredients.
Danish: Alle styrkerne anført ovenfor indeholder de andre indholdsstoffer.
English: Differences between the 2 groups were statistically significant (p < 0.05) for all criteria listed.
Danish: Forskellen mellem de 2 grupper var statistisk signifikant (p < 0,05) for alle anførte kriterier.
English: This medicine usually does not work if you have this problem.
Danish: Dette lægemiddel er normalt ikke effektivt, hvis du har dette problem.
English: • you have difficulty in breathing.
Danish: • du har åndedrætsbesvær.
English: Proper treatment of your condition, however, requires close and constant co-operation with your doctor.
Danish: En korrekt behandling af din sygdom kræver imidlertid nøje og konstant samarbejde med lægen.
English: Children and adolescents This medicine is not indicated for use in children and adolescents less than 18 years of age.
Danish: Børn og unge Dette lægemiddel er ikke indiceret til børn og unge under 18 år.
English: Do not use this medicine if any of the above applies to you.
Danish: Brug ikke dette lægemiddel, hvis noget af ovenstående gælder for dig.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 27 September 2013.
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN Dato for første markedsføringstilladelse: 27. september 2013.
English: • This medicine is usually given every day.
Danish: • Dette lægemiddel gives normalt dagligt.
English: The majority of multiple conceptions are twins.
Danish: Størstedelen af flerfoldsfødsler er tvillinger.
English: It is advised to adhere to the recommended starting doses indicated below.
Danish: Det anbefales, at man holder fast ved den anbefalede startdosis, som er angivet nedenfor.
English: • The dose may be increased, depending on your response.
Danish: • Dosis kan øges, afhængigt af den virkning, du opnår.
English: Benzyl alcohol may cause allergic reactions.
Danish: Benzylalkohol kan medføre allergiske reaktioner.
English: If you are a man, having too much natural FSH in your blood can be a sign of damaged testicles.
Danish: Hvis du er en mand, kan for meget naturligt FSH i blodet være et tegn på beskadigede testikler.
English: The first injection should be performed under direct medical supervision.
Danish: Den første injektion skal udføres under direkte medicinsk overvågning.
English: Following subcutaneous administration, the absolute bioavailability is about 70 %.
Danish: Efter subkutan anvendelse er den absolutte biotilgængelighed ca. 70 %.
English: • you gain any weight rapidly,
Danish: • du tager meget hurtigt på i vægt
English: Please talk to your doctor as soon as you realise that you forgot a dose.
Danish: Kontakt din læge så snart, du opdager, at du har glemt en dosis.
English: The doses described below are stated in International Units (IU).
Danish: Doserne, der er beskrevet herunder, er anført i internationale enheder (IE).
English: You can reduce the risk of multiple pregnancy by using the right dose of this medicine at the right times.
Danish: Du kan nedsætte risikoen for flerfoldsgraviditet ved at tage den rette dosis af dette lægemiddel på de rette tidspunkter.
English: It may be acceptable to extend the duration of stimulation in any one cycle to up to 5 weeks.
Danish: Det kan accepteres at forlænge stimulationstiden i en cyklus op til 5 uger.
English: Each cartridge must be used by a single patient only.
Danish: Hver cylinderampul må kun anvendes af en enkelt patient.
English: Ovaleap must not be used when an effective response cannot be obtained, such as:
Danish: Ovaleap må ikke anvendes når effektivt respons ikke kan opnås, som for eksempel:
English: The lowest effective dose in relation to the treatment objective should be used in both men and women.
Danish: Den laveste dosis i relation til behandlingsårsagen skal bruges til både mænd og kvinder.
English: Store in a refrigerator (2 °C - 8 °C).
Danish: Opbevares i køleskab (2 °C-8 °C).
English: Therefore, patients should be followed for at least 2 weeks after hCG administration.
Danish: Derfor skal patienten følges i mindst 2 uger efter hCG administration.
English: Multiple pregnancy may lead to medical complications for you and your babies.
Danish: Flerfoldsgraviditet kan medføre medicinske komplikationer for dig selv og dine spædbørn.
English: However, it should be taken into account that there are variations between LH measurements performed in different laboratories.
Danish: Imidlertid skal man tage hensyn til mulige variationer af LH niveaumålinger foretaget i forskellige laboratorier.
English: • You will use these two medicines each day for up to 5 weeks.
Danish: • Du skal tage disse to lægemidler hver dag i op til 5 uger.
English: It most often occurs after hormonal treatment has been discontinued and reaches its maximum at about 7 to 10 days following treatment.
Danish: Det sker oftest efter hormonbehandlingen er seponeret, og når sit maksimum ca. 7 til 10 dage efter behandling.
English: 6.6 Special precautions for disposal and other handling No special requirements for disposal.
Danish: 6.6 Regler for bortskaffelse og anden håndtering Ingen særlige forholdsregler ved bortskaffelse.
English: FSH is a gonadotropin, a type of hormone that plays an important role in human fertility and reproduction.
Danish: FSH er en gonadotropin, en type hormon, som spiller en vigtig rolle i human fertilitet og reproduktion.
English: Your doctor will use blood tests and/or an ultrasound machine to check when this is.
Danish: Din læge vil bruge blodprøver og/eller et ultralydsapparat til at kontrollere, hvornår dette punkt er nået.t
English: Tell your doctor straight away if:
Danish: Fortæl det straks til lægen hvis:
English: Overall experience with IVF indicates that in general the treatment success rate remains stable during the first four attempts and gradually declines thereafter.
Danish: Erfaringen med IVF viser at frekvensen for vellykket behandling sædvanligvis er stabil under de fire første forsøg og derefter gradvist aftager.
English: This is because large amounts of benzyl alcohol can build-up in your body and may cause side effects (called “metabolic acidosis”).
Danish: Dette skyldes, at store mængder benzylalkohol kan ophobes i din krop og kan medføre bivirkninger (kaldet "metabolisk acidose”).
English: Since these patients are amenorrhoeic and have low endogenous oestrogen secretion, treatment can commence at any time.
Danish: Da disse patienter er amenorréiske og har lav endogen østrogen sekretion, kan behandling påbegyndes når som helst.
English: However, since Ovaleap is not indicated in pregnancy, these data are of limited clinical relevance.
Danish: Eftersom Ovaleap ikke er indiceret under graviditet, er disse data dog af begrænset klinisk relevans.
English: The Ovaleap and GnRH agonist are then both given until your follicles develop as desired.
Danish: Ovaleap og GnRH-agonister gives dernæst begge, indtil dine follikler udvikler sig som ønsket.
English: The adverse reactions are ranked under heading of frequency using the following convention: 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) and not known (cannot be estimated from the available data).
Danish: Bivirkningerne er klassificeret efter hyppighed ved brug af den følgende konvention: 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) og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: The very first injection of this medicine should only be given in the presence of a doctor or nurse.
Danish: Den allerførste injektion af dette lægemiddel bør kun gives, når der er en læge eller sundhedspersonale til stede.
English: Your doctor or nurse will give you instructions on how to do this and you can also find instructions in the separate instructions for use of the pen.
Danish: Din læge eller sundhedspersonalet vil give dig anvisninger i hvordan det gøres, og du kan også finde anvisningerne i den separate brugsanvisning for pennen.
English: Do not attempt to self-administer this medicine without this training by your doctor or nurse.
Danish: Forsøg ikke at selvadministrere dette lægemiddel uden denne træning fra din læge eller sundhedspersonalet.
English: This is a condition that may be passed on from parents to children which means that you have an inability to break down porphyrins (organic compounds).
Danish: Det er en sygdom, der kan nedarves fra forældre til børn, hvilket betyder, at du ikke er i stand til at nedbryde porfyriner (organiske stoffer).
English: Exacerbation or aggravation of asthma
Danish: Eksacerbationer eller forværring af astma
English: If after this period, the patient has not responded, the combination treatment may be continued; current clinical experience indicates that treatment for at least 18 months may be necessary to achieve spermatogenesis.
Danish: Hvis patienten efter denne periode ikke har responderet, kan kombinationsbehandling fortsættes; nuværende klinisk erfaring indikerer, at behandling i mindst 18 måneder kan være nødvendigt for at fremme spermatogenesen.
English: There is no indication for use of Ovaleap during pregnancy.
Danish: Der er ingen indikation for anvendelse af Ovaleap under graviditeten.
English: • you have stomach, arm or leg pain.
Danish: • hvis du har smerter i mave, arme eller ben
English: In order to improve the traceability of biological medicinal products, the trade name and batch number of the administered medicinal product should be clearly recorded in the patient file.
Danish: For at forbedre sporbarheden af biologiske lægemidler, skal handelsnavnet og batchnummeret for det administrerede lægemidlet klart angives i patientjournalen.
English: The solution must not be used if it contains particles or if the solution is not clear.
Danish: Brug ikke opløsningen, hvis den indeholder partikler, eller hvis opløsningen er uklar.
English: Self-administration should only be performed by patients who are well motivated, adequately trained and have access to expert advice.
Danish: Selvadministration bør kun udføres af patienter, som er motiverede, har modtaget tilstrækkelig instruktion, og som har mulighed for at konsultere kvalificeret fagpersonale.
English: Monitoring of stimulation cycles by ultrasound scans as well as oestradiol measurements are recommended to early identify risk factors.
Danish: Monitorering af stimulationscyklusser med ultralydsscanning såvel som målinger af estradiol anbefales for tidlig identifikation af risikofaktorer.
English: It should be noted however that pregnancy itself as well as OHSS also carry an increased risk of thromboembolic events.
Danish: Det skal noteres, at graviditet i sig selv såvel som OHSS også øger risikoen for en tromboembolisk hændelse.
English: 4.8 Undesirable effects Summary of the safety profile
Danish: 4.8 Bivirkninger Oversigt over sikkerhedsprofil
English: ● Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Danish: • når risikostyringssystemet ændres, særlig som følge af, at der er modtaget nye oplysninger, der kan medføre en væsentlig ændring i benefit/risk -forholdet, eller som følge af, at en vigtig milepæl (lægemiddelovervågning eller risikominimering) er nået.
English: As the multidose cartridge is intended for several injections, clear instructions should be provided to the patients to avoid misuse of the medicine.
Danish: Da flerdosis cylinderampullen er beregnet til flere injektioner, bør patienten modtage klar instruktion, for at undgå forkert brug af lægemidlet.
English: If you think you are having this type of reaction, you must stop your Ovaleap injection and get medical help immediately.
Danish: Hvis du mener, at du har denne type reaktion, skal du stoppe injektionen med Ovaleap og øjeblikkeligt søge lægehjælp.
English: The maximum daily dose is 450 IU.
Danish: Den maksimale daglige dosis er 450 IE.
English: • If you have irregular periods, start using this medicine within the first 7 days of your menstrual cycle.
Danish: • Hvis du har uregelmæssig menstruation, skal du starte med at bruge dette lægemiddel inden for de første 7 dage af din menstruationscyklus.
English: 4.7 Effects on ability to drive and use machines Ovaleap has no or negligible influence on the ability to drive and use machines.
Danish: 4.7 Virkning på evnen til at føre motorkøretøj og betjene maskiner Ovaleap påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: • fibroid tumours of the uterus incompatible with pregnancy;
Danish: • fibroide tumorer i uterus uforenelige med graviditet,
English: Data on a limited number of exposed pregnancies (less than 300 pregnancy outcomes) indicate no malformative or foeto/neonatal toxicity of follitropin alfa.
Danish: Data fra et begrænset antal eksponerede graviditeter (mindre end 300 gravide forsøgspersoner) indikerer ingen misdannelser eller føtal/neonatal toksicitet af follitropin alfa.
English: In women, FSH is needed for the growth and development of the sacs (follicles) in the ovaries that contain the egg cells.
Danish: Hos kvinder er FSH nødvendigt til vækst og udvikling af sækkene (follikler) i æggestokkene (ovarierne), der indeholder ægcellerne.
English: Then Ovaleap is given approximately 2 weeks after the start of agonist treatment.
Danish: Dernæst startes Ovaleap ca. 2 uger efter start af agonistbehandling.
English: Ovaleap is a biosimilar medicinal product.
Danish: Ovaleap er et biosimilært lægemiddel.
English: Mild to severe hypersensitivity reactions, including anaphylactic reactions and shock
Danish: Lette til alvorlige overfølsomhedsreaktioner inklusive anafylaktiske reaktioner og shock
English: Mild or moderate OHSS usually resolves spontaneously.
Danish: Let eller moderat OHSS forsvinder sædvanligvist spontant.
English: You can also report side effects directly via the national reporting system listed in Appendix V.. By reporting side effects you can help provide more information on the safety of this medicine.
Danish: Du eller dine pårørende kan også indberette bivirkninger direkte til Lægemiddelstyrelsen via det nationale rapporteringssystem anført i Appendiks V. Ved at indrapportere bivirkninger kan du hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.
English: Complication of severe OHSS
Danish: Komplikationer ved svær OHSS
English: The instructions for use of the pen must be followed carefully.
Danish: Brugsanvisningen for pennen skal følges nøje.
English: The steady state volume of distribution and total clearance are 10 L and 0.6 L/h, respectively.
Danish: Steady state-fordelingsrummet og den totale clearance er henholdsvis 10 liter og 0,6 liter/time.