natgillin/translations-raw huggingface dataset:
1 cylinderampul indeholder 3 ml svarende til 300 IE. 1 ml injektionsvæske indeholder 100 IE humant insulin (50% som opløseligt insulin og 50% som isophaninsulin) (svarende til 3,5 mg),
1 ml suspension contains 100 IU insulin human (50% as soluble insulin and 50% as isophane insulin) (equivalent to 3.5 mg),
Actraphane 30 100 IE/ml Injektionsvæske, suspension Humant insulin
Actraphane 30 100 IU/ml Suspension for injection Insulin human
Hvis du har taget for meget insulin
If you take more insulin than you should
Actraphane 30 FlexPen 100 IE/ml Injektionsvæske, suspension i fyldt pen Humant insulin
Actraphane 30 FlexPen 100 IU/ml Suspension for injection in pre-filled pen Insulin human
1 cylinderampul indeholder 3 ml svarende til 300 IE. 1 ml injektionsvæske indeholder 100 IE humant insulin (40% som opløseligt insulin og 60% som isophaninsulin) (svarende til 3,5 mg),
1 ml suspension contains 100 IU insulin human (40% as soluble insulin and 60% as isophane insulin) (equivalent to 3.5 mg),
Pakninger med 1, 5 og 10 cylinderampuller.
Pack sizes of 1, 5 and 10 cartridges.
Biotransformation
Metabolism
1 cylinderampul indeholder 3 ml svarende til 300 IE. 1 ml injektionsvæske indeholder 100 IE humant insulin (30% som opløseligt insulin og 70% som isophaninsulin) (svarende til 3,5 mg),
1 ml suspension contains 100 IU insulin human (30% as soluble insulin and 70% as isophane insulin) (equivalent to 3.5 mg),
Indlægsseddel: Information til brugeren Actraphane 30 40 IE/ml (internationale enheder/ml) injektionsvæske, suspension i hætteglas humant insulin
Package leaflet: Information for the user Actraphane 30 40 IU/ml (international units/ml) suspension for injection in vial human insulin
Kontrol af insulingennemløb
Checking the insulin flow F
Indlægsseddel: Information til brugeren Actraphane 30 FlexPen 100 IE/ml (internationale enheder/ml) injektionsvæske, suspension i fyldt pen humant insulin
Package leaflet: Information for the user Actraphane 30 FlexPen 100 IU/ml (international units/ml) suspension for injection in pre-filled pen human insulin
EU/1/02/229/017 1 cylinderampul a 3 ml EU/1/02/229/018 5 cylinderampuller a 3 ml EU/1/02/229/019 10 cylinderampuller a 3 ml
EU/1/02/229/017 1 cartridge of 3 ml EU/1/02/229/018 5 cartridges of 3 ml EU/1/02/229/019 10 cartridges of 3 ml
Indlægsseddel: Information til brugeren Actraphane 50 Penfill 100 IE/ml (internationale enheder/ml) injektionsvæske, suspension i cylinderampul humant insulin
Package leaflet: Information for the user Actraphane 50 Penfill 100 IU/ml (international units/ml) suspension for injection in cartridge human insulin
Actraphane 50 Penfill 100 IE/ml Injektionsvæske, suspension i cylinderampul Humant insulin
Actraphane 50 Penfill 100 IU/ml Suspension for injection Insulin human
Actraphane 30 Penfill 100 IE/ml Injektionsvæske, suspension i cylinderampul Humant insulin
Actraphane 30 Penfill 100 IU/ml Suspension for injection Insulin human
Opbevar FlexPen med penhætten påsat, når du ikke anvender den, for at beskytte den mod lys.
Always keep the pen cap on your FlexPen when you are not using it, in order to protect from light.
Indlægsseddel: Information til brugeren Actraphane 30 InnoLet 100 IE/ml (internationale enheder/ml) injektionsvæske, suspension i fyldt pen humant insulin
Package leaflet: Information for the user Actraphane 30 InnoLet 100 IU/ml (international units/ml) suspension for injection in pre-filled pen human insulin
Kontakt straks din læge, hvis symptomerne ikke forsvinder, eller hvis de spreder sig til andre dele af kroppen.
If they do not disappear, or if they spread throughout your body, talk to your doctor immediately.
Indlægsseddel: Information til brugeren Actraphane 40 Penfill 100 IE/ml (internationale enheder/ml) injektionsvæske, suspension i cylinderampul humant insulin
Package leaflet: Information for the user Actraphane 40 Penfill 100 IU/ml (international units/ml) suspension for injection in cartridge human insulin
Actraphane 40 Penfill 100 IE/ml Injektionsvæske, suspension i cylinderampul Humant insulin
Actraphane 40 Penfill 100 IU/ml Suspension for injection Insulin human
Actraphane 30 InnoLet 100 IE/ml Injektionsvæske, suspension i fyldt pen Humant insulin
Actraphane 30 InnoLet 100 IU/ml Suspension for injection in pre-filled pen Insulin human
Indlægsseddel: Information til brugeren Actraphane 30 Penfill 100 IE/ml (internationale enheder/ml) injektionsvæske, suspension i cylinderampul humant insulin
Package leaflet: Information for the user Actraphane 30 Penfill 100 IU/ml (international units/ml) suspension for injection in cartridge human insulin
Actraphane 30 FlexPen 100 IE/ml Injektionsvæske, suspension Humant insulin s.c.
Actraphane 30 FlexPen 100 IU/ml Suspension for injection Insulin human
Indlægsseddel: Information til brugeren Actraphane 30 100 IE/ml (internationale enheder/ml) injektionsvæske, suspension i hætteglas humant insulin
Package leaflet: Information for the user Actraphane 30 100 IU/ml (international units/ml) suspension for injection in vial human insulin
Injektionsvæske, suspension 1 hætteglas a 10 ml
Suspension for injection 1 vial of 10 ml 5 vials of 10 ml
Brug ikke lægemidlet efter den udløbsdato, der står på etiketten og pakningen med cylinderampuller efter 'EXP'.
Do not use this medicine after the expiry date, which is stated on the vial label and carton after ‘EXP'.
Actraphane 30 hætteglas (100 internationale enheder/ml) 1 hætteglas indeholder 10 ml svarende til 1.000 internationale enheder.
Actraphane 30 vial (40 international units/ml)/Actraphane 30 vial (100 international units/ml) Vial (type 1 glass) closed with a disc (bromobutyl/polyisoprene rubber) and a protective tamper-proof plastic cap containing 10 ml of suspension.
Actraphane 30 40 IE/ml Injektionsvæske, suspension Humant insulin s.c.
Actraphane 30 40 IU/ml Suspension for injection Insulin human SC
Actraphane 30 InnoLet 100 IE/ml Injektionsvæske, suspension Humant insulin s.c.
Actraphane 30 InnoLet 100 IU/ml Suspension for injection Insulin human
Actraphane 30 100 IE/ml Injektionsvæske, suspension Humant insulin s.c.
Actraphane 30 100 IU/ml Suspension for injection Insulin human SC
Den første infusion varer 15 minutter.
The first infusion lasts 15 minutes.
ATryn er blevet godkendt under "særlige omstændigheder".
ATryn has been authorised under ‘exceptional circumstances'.
Den fuldstændige EPAR for ATryn findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The full EPAR for ATryn can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for ATryn.
This document is a summary of the European Public Assessment Report (EPAR) for ATryn.
Dette er dog endnu ikke observeret hos patienter behandlet med ATryn.
However, this has not yet been seen in patients treated with ATryn.
Endvidere blev ATryn anvendt til fem patienter, som fik lægemidlet under operation i et "program for anvendelse med særlig udleveringstilladelse" (et program, hvor lægen kan anmode om lægemidlet til en af sine patienter, inden det er godkendt).
In addition, ATryn was used in five patients who received the medicine during surgery in a ‘compassionate-use programme' (a programme through which doctors can request a medicine for one of their patients before it is authorised).
Dette efterfølges af en kontinuerlig infusion i en lavere dosis, i løbet af hvilken patienten skal overvåges konstant, og infusionshastigheden skal justeres, så antithrombinaktiviteten ligger på mindst 80 % af normalværdien i hele behandlingsperioden.
This is followed by a continuous infusion at a lower dose, during which the patients should be continually monitored and the infusion rate adjusted, so that the antithrombin activity is at least 80% of the normal level for the duration of treatment.
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv
What measures are being taken to ensure the safe and effective use of Atryn?
Lægen beregner, hvilken dosis der skal anvendes, på grundlag af såvel patientens vægt som patientens antithrombinaktivitetsniveau.
The doctor needs to calculate the doses to use, based both on the patient's weight and on the level of antithrombin activity.
Der forelå imidlertid ikke tilstrækkelige oplysninger til at fastlægge den mest egnede dosis
However, there was not enough information to identify the most appropriate dose to use during childbirth.
CHMP konkluderede, at de oplysninger, som virksomheden havde fremlagt, havde vist, at ATryn kan bringe antithrombinaktivitetsværdierne op på et acceptabelt niveau, når det anvendes i den anbefalede dosis under operation.
The CHMP concluded that the information provided by the company had shown that ATryn can bring the antithrombin activity up to an acceptable level when used at the recommended dose during surgery.
Hvilke oplysninger afventes der stadig for ATryn?
What information is still awaited for ATryn?
Da ATryn er et protein, der gives ved injektion, kan patienterne udvikle antistoffer (proteiner, som dannes mod lægemidlet), så der er risiko for en allergisk reaktion, når injektionen gives.
Because ATryn is a protein given by injection, patients could develop antibodies (proteins produced in response to the medicine), with a risk of an allergic reaction at the time of injection.
Behandling med ATryn bør kun indledes af læger med erfaring i behandling af patienter med medfødt antithrombinmangel.
Treatment with ATryn should only be started by doctors who are experienced in treating patients with congenital antithrombin deficiency.
Hvilken risiko er der forbundet med ATryn?
What is the risk associated with ATryn?
Udvalget fandt, at fordelene ved ATryn opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse.
The Committee decided that ATryn's benefits are greater than its risks and recommended that it be given marketing authorisation.
Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om,
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for ATryn.
I undersøgelserne målte man, hvor mange patienter, der udviklede dyb venethrombose (DVT, dannelse af en blodprop i en dybtliggende vene, sædvanligvis i benet) i løbet af de 30 dage, der fulgte efter behandlingen.
The studies measured how many patients developed deep vein thrombosis (DVT, formation of a blood clot in a deep vein, usually in the leg) during the 30 days after treatment.
Virksomheden, som fremstiller ATryn, har forelagt agenturet resultaterne af en undersøgelse, der ser nærmere på anvendelsen af ATryn under fødsel hos kvinder med medfødt antithrombinmangel, og skal indgive en ansøgning med det formål at føje behandling under fødsel til lægemidlets markedsføringstilladelse.
The company that makes ATryn has provided the results of a study looking at the use of ATryn during childbirth in women with congenital antithrombin deficiency to the Agency, and will submit an application with the aim of adding treatment during childbirth to the medicine's marketing authorisation.
Der blev gennemført en undersøgelse med ATryn hos 14 patienter i alderen 21 til 74 år, som havde medfødt antithrombinmangel, og som havde risiko for dannelse af blodpropper enten under operation (fem patienter) eller under fødsel (ni patienter).
One study of ATryn was carried out in 14 patients aged between 21 and 74 years who had congenital antithrombin deficiency and were at risk of blood clot formation either during surgery (five patients) or during childbirth (nine patients).
ATryn bør ikke anvendes til personer, der kan være overfølsomme (allergiske) over for gedeproteiner eller gedemælk.
ATryn must not be used in people who may be hypersensitive (allergic) to goat proteins or goat milk.
Virksomheden skal også inden markedsføring i EU-medlemsstater indføre programmer for at sikre, at læger kan indberette oplysninger om de patienter, de behandler, og følge
The company will also put in place, before launch in any European Union (EU) Member State, programmes to ensure that doctors can report information on the patients they treat and monitor the development of antibodies against ATryn.
ATryn gives normalt med heparin (et andet lægemiddel, som medvirker til at forebygge
ATryn is normally given with heparin (another medicine that helps to prevent blood clots).
Det betyder, at det ikke har været muligt at indhente fyldestgørende oplysninger om ATryn, fordi sygdommen er sjælden.
This means that because the disease is rare, it has not been possible to obtain complete information about ATryn.
I kroppen blokerer antithrombin thrombin, som er et stof, der spiller en central rolle i blodstørkningsprocessen.
In the body, antithrombin blocks thrombin, a substance that plays a central role in the process of blood clotting.
Hvis du ønsker yderligere oplysninger om behandling med ATryn, kan du læse indlægssedlen (også en del af denne EPAR) eller
For more information about treatment with ATryn, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Patienter med medfødt antithrombinmangel har et lavt indhold af antithrombin i blodet og har derfor større risiko for at få blodpropper.
Patients who have congenital antithrombin deficiency have low blood antithrombin levels and are therefore at increased risk of having blood clots.
Den fuldstændige liste over bivirkninger og begrænsninger ved ATryn fremgår af indlægssedlen.
For the full list of side effects and restrictions with ATryn, see the package leaflet.
ATryn er et pulver, der blandes til en opløsning til infusion (drop i en vene).
ATryn is a powder that is made up into a solution for infusion (drip) into a vein.
ATryn anvendes til voksne med "medfødt antithrombinmangel" (nedarvede lave niveauer af proteinet antithrombin).
ATryn is used in adults who have ‘congenital antithrombin deficiency' (inherited low levels of the protein antithrombin).
Kun få patienter blev behandlet i løbet af undersøgelsen, fordi medfødt antithrombinmangel er sjælden - det anslås, at kun ca. en person ud af
Few patients were treated during the study because congenital antithrombin deficiency is rare - it is estimated that only about one person in 3,000 to 5,000 has the condition.
Det anvendes ved operation for at forebygge problemer som følge af dannelse af blodpropper.
It is used when the patients are having surgery, to prevent problems due to the formation of blood clots.
I programmet for anvendelse med særlig udleveringstilladelse optrådte der ingen blodpropper hos de patienter, som fik ATryn.
In the compassionate-use programme, no blood clots were seen in the patients receiving ATryn.
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske
The European Commission granted a marketing authorisation valid throughout the EU for ATryn on 28 July 2006.
I undersøgelserne var de hyppigste bivirkninger ved ATryn (som optræder hos mellem 1 og 10 ud af 100 patienter) svimmelhed, hovedpine, blødning (enten blødning på injektionsstedet eller blødning efter operation), kvalme og væskeudsivning fra operationssåret.
In studies, the most common side effects with ATryn (seen in between 1 and 10 patients in 100) were dizziness, headache, haemorrhage (bleeding, including bleeding at the site of the injection or after surgery), nausea (feeling sick) and wound secretion (discharge from the surgical wound).
Resultaterne som helhed understøtter virkningen af ATryn til forebyggelse af, at patienter udvikler blodpropper under operation.
Taken together, the results support the effectiveness of ATryn in preventing blood clot development in patients having surgery.
To af de 13 patienter i undersøgelsen, hos hvem behandlingens virkning kunne vurderes, fik dyb venethrombose.
In the study, among the 13 patients in whom the effectiveness of the treatment could be assessed, two had an episode of DVT, of which only one needed treatment.
ATryn retter op på manglen på antithrombin og korrigerer derved midlertidigt forstyrrelsen i blodets koagulation.
ATryn corrects the antithrombin deficiency, and gives temporary control of the clotting disorder.
Hvilken fordel viser undersøgelserne, der er ved ATryn?
What benefit has ATryn shown during the studies?
De fuldstændige anvisninger fremgår af indlægssedlen.
See the package leaflet for full instructions.
Hvordan virker ATryn?
How does ATryn work?
I produktresuméet og indlægssedlen er der indføjet anbefalinger og forholdsregler, som sundhedspersonale og patienter skal følge med henblik på sikker og effektiv anvendelse af ATryn.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Atryn have been included in the summary of product characteristics and the package leaflet.
Det fremstilles ved "rekombinant dna-teknologi": Det udvindes af mælken fra geder, der har fået indsat et gen (dna), der gør dem i stand til at danne det menneskelige protein i mælken.
The active substance in ATryn, antithrombin alfa, is a copy of the natural blood protein antithrombin, which is produced by ‘recombinant DNA technology': it is extracted from the milk of goats that have had a gene (DNA) inserted, which makes them able to produce the human protein in their milk.
Det aktive stof i ATryn, antithrombin alfa, er en kopi af det naturlige protein antithrombin i blodet.
It contains the active substance antithrombin alfa.
Den indeholder vigtige oplysninger om, hvordan disse to lægemidler skal tages.
It contains important information about how to take these two medicines.
* Statistiske tests blev ikke udført på grund af små tal for de enkelte mutationer.
* Statistical testing was not performed due to small numbers for individual mutations.
Som sådan kan en risiko for nyfødte/spædbørn ikke udelukkes.
As such, a risk to the newborns/infants cannot be excluded.
Løft her for at åbne
Lift here to open
Peri- og postnatal udvikling
Peri- and post-natal development
Der blev observeret tilfælde, der tydede på positiv rechallenge.
Cases suggestive of positive rechallenge were observed.
* Værdier baseret på data fra en enkelt patient; standardafvigelse ikke rapporteret.
* Values based on data from a single patient; standard deviation not reported.
Ikke alle pakningsstørrelser er nødvendigvis markedsført
Not all pack sizes may be marketed
Brug doserne til alle 7 dage, inden du starter på en ny mappe.
Use all 7 days' doses before starting a new wallet.
For patienter, som blev overført fra studie 2, var antallet af hændelser overordnet set lavt.
For patients who rolled over from study 2 the number of events was, overall, low.
Den mulige relevans af disse fund for mennesker er ukendt.
The potential relevance of these findings in humans is unknown.
Det kan være bedst at undgå at anvende Kalydeco under graviditeten, hvis det er muligt, og din læge vil hjælpe dig med at beslutte, hvad der er det bedste for dig og dit barn.
It may be better to avoid using Kalydeco during pregnancy, if possible, and your doctor will help you decide what is best for you and your child.
Studie 4: åbent forlængelsesstudie
Study 4: open-label extension study
I sådanne tilfælde bør startdosis være som anbefalet ovenfor, men administreret hver anden dag.
In such cases, the starting dose should be as above recommended, but administered every other day.
Behandlingsforskela (95 % CI)
Treatment differencea (95% CI)
Patienterne skal instrueres i at sluge tabletterne hele.
Patients should be instructed to swallow the tablets whole.
• gulfarvning af huden eller af det hvide i øjnene
• Yellowing of the skin or the white part of the eyes
Bivirkninger, der observeres hos børn og unge, svarer til dem, der observeres hos voksne.
Side effects seen in children and adolescents are similar to those observed in adults.
Dato for første markedsføringstilladelse: 23. juli 2012 Dato for seneste fornyelse: 28. april 2017
Date of first authorisation: 23 July 2012 Date of latest renewal: 28 April 2017
Natriumlaurilsulfat (E487)
Sodium laurilsulfate (E487)
* Behandlingen fandt sted i løbet af et blindet, kontrolleret 48-ugers fase 3-studie.
* Treatment occurred during blinded, controlled, 48-week Phase 3 study.
Tag tabletterne med ca. 12 timers mellemrum.
Take the tablets approximately 12 hours apart.
Et åbent, 96-ugers rollover-studie er i gang for at evaluere sikkerheden og virkningen på langt sigt af kombinationsregimet i begge patientpopulationer.
An open-label, rollover, 96 week study is on-going to evaluate the long-term safety and efficacy of the combination regimen in both patient populations.
Derfor er dosisjustering af oral kontraception ikke nødvendig.
Therefore, no dose adjustment of oral contraceptives is necessary.
Median (min; maks)
Median (min, max)
Se sidst i punkt 2 - Vigtige oplysninger om Kalydecos indhold.
See the end of section 2 - Important information about the contents of Kalydeco.
Kalydeco er til oral anvendelse.
Kalydeco is for oral use.
4.5 for interaktioner med ciclosporin eller tacrolimus.
See section 4.5 for interactions with ciclosporin or tacrolimus.
Behandling af en overdosis består af generel støttebehandling, herunder monitorering af vitale tegn, leverfunktionsprøver og observation af patientens kliniske status.
Treatment of overdose consists of general supportive measures including monitoring of vital signs, liver function tests and observation of the clinical status of the patient.
Derfor anbefales leverfunktionsprøver for alle patienter, før ivacaftor påbegyndes, hver 3. måned i løbet af det første års behandling og derefter årligt.
Therefore, liver function tests are recommended for all patients prior to initiating ivacaftor, every 3 months during the first year of treatment and annually thereafter.
Ivacaftors potentiale til at interagere med transportører
Potential for ivacaftor to interact with transporters
Hvert brev er kun til engangsbrug.
Each sachet is for single use only.
Tertiære endepunkter omfattede virkningsmålinger, såsom fækal elastase-1 og vækstparametre.
Tertiary endpoints included efficacy measures such as Faecal Elastase-1 and growth parameters.
Forhøjede niveauer af leverenzymer i blodet observeres dog hyppigere hos små børn.
However, increased liver enzymes in the blood are more frequently seen in young children.
25 kg eller mere
25 kg or more
Tlf.: +353 (0)1 761 7299
Tel: +353 (0)1 761 7299
Der var ingen yderligere forbedring i studie 4 (uge 48 til og med uge 144).
There were no additional improvements in study 4 (week 48 through week 144).
I alt 36 patienter fortsatte i del 2 (18 i hver behandlingssekvens).
A total of 36 patients continued into part 2 (18 per treatment sequence).
Relativ risiko for lungeforværring
Relative risk of pulmonary exacerbation
Virkningen af mad på absorptionen af ivacaftor er tilsvarende for begge formuleringer, dvs. tabletter og granulat.
The effect of food on ivacaftor absorption is similar for both formulations, i.e., tablets and granules.
Nogle lægemidler kan påvirke den måde, Kalydeco virker på, eller gøre bivirkninger mere sandsynlige.
Some medicines can affect how Kalydeco works, or make side effects more likely.
Absolut ændring ved uge 24
Absolute change at week 24
Ved starten af studiet anvendte patienterne i placebogruppen nogle lægemidler med en større hyppighed end i ivacaftor-gruppen.
At the start of the study, patients in the placebo group used some medicinal products at a higher frequency than the ivacaftor group.
†† n=3 for analysen af den absolutte ændring i sved-chlorid.
†† n = 3 for the analysis of absolute change in sweat chloride.
Der er ingen eller utilstrækkelige data (mindre end 300 gravide forsøgspersoner) fra anvendelse af ivacaftor til gravide kvinder.
There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of ivacaftor in pregnant women.
Voksne (≥ 18 år)
Adults (≥ 18 years old)