natgillin/translations-raw huggingface dataset:
CHMP vedtog den 26. maj 2005, at der er behov for at indkalde til et ad hoc- ekspertgruppemøde om rekombinante hepatitis B- vacciners lang - og korttidsbeskyttende effekt mod hepatitis.
On 26 May 2005, the CHMP agreed on the need to convene an Ad Hoc Expert Group Meeting on Hepatitis short and long-term protection afforded by recombinant Hepatitis B vaccines.
Denne variabilitet synes at være forbundet med variationer, som i øjeblikket er ukontrollerbare, i fremstillingsprocessen af den rekombinante HepB - vaccinekomponent.
This variability seems to be related to currently uncontrollable variances in the manufacturing process of the recombinant HepB vaccine component.
Der blev udtrykt bekymring over HepB- komponentens lave immunogenicitet i Hexavac, de mulige konsekvenser ved langtidsbeskyttelse mod hepatitis B- infektion og booster- evnen efter det primære vaccinationsforløb med denne vaccine.
Concerns were expressed on the low immunogenicity of the HepB component of Hexavac and the potential consequences on long-term protection against Hepatitis B infection and boostability post primary course of vaccination with this vaccine.
Mellem juli og september 2005 fremsatte indehaveren af markedsføringstilladelsen mundtlige forklaringer til CHMP og arbejdsgrupperne om HepB- komponentens lave immunogenicitet ved den langtidsbeskyttende effekt af Hexavac mod hepatitis B.
Between July and September 2005, the marketing authorisation holder gave oral explanations to the CHMP and its working parties on the low immunogenicity of the HepB component in long-term protection against Hepatitis B afforded by Hexavac.
2309/ 93 (med ændringer), efter at CHMP havde udtrykt bekymringer over den lave immunogenicitet af HepB- komponenten i Hexavac.
On 14 September 2005, the European Commission (EC) triggered the procedure under Article 18 of Council Regulation (EEC) No 2309/ 93, as amended, after the CHMP expressed concerns on the low immunogenicity of the HepB component of Hexavac.
2309/ 93 (med ændringer).
The CHMP was requested to give an opinion as to whether the marketing authorisation for Hexavac should be maintained, varied, suspended or withdrawn in the context of an Article 18 of Council Regulation (EEC) No 2309/ 93, as amended, procedure.
Bekymringerne for HepB- komponentens immunogenicitet voksede, da der blev observeret lavere serokonversionsrater end forventet efter samtidig administration af Hexavac og andre meningokok - og pneumokokvacciner.
The concerns over the immunogenicity of the HepB component increased when lower than expected seroconversion rates were observed following the concomitant administration of Hexavac with other meningococcal and pneumococcal vaccines.
Indehaveren af markedsføringstilladelsen undersøgte de uforudsigelige variationer i HepB - komponentens immunogenicitet.
Unpredictable variances to the immunogenicity of the HepB component were investigated by the MAH.
Indehaveren af markedsføringstilladelsen har undersøgt kritiske trin i fremstillingsprocessen, og et ændret procestrin blev identificeret som den mest sandsynlige strategi i forbindelse med øgning af HepB- komponentens immunogenicitet.
Critical steps of the manufacturing process have been investigated by the marketing authorisation holder (MAH), and a modified process step was identified as the most likely strategy to enhance immunogenicity of the HepB component.
Der blev givet udtryk for bekymringer med hensyn til det seneste resultat, som påviser, at børn, der har modtaget en primærvaccine med Hexavac, tilsyneladende responderer på en booster- dosis af en
Additional concerns were raised by the recent finding that children primary immunised with Hexavac apparently respond to a booster dose of a monovalent Hepatitis B vaccine as a function of the geometric mean titres (GMTs) achieved upon completion of the primary immunisation series.
1 monovalent hepatitis B- vaccine som en funktion af de antistoftitre, der blev opnået efter afslutning på den primære immunisering.
1 number of infants but raised concerns because the findings of a challenge ‘ weaker ’ than priming with or without booster dose are unexpected.
På den anden side foreligger der i øjeblikket ingen rapporter om hepatitis B- gennembrudsanfald efter Hexavac- vaccination, når der tages højde for, at EU er et lavendemisk område, og at individuelle risici potentielt først øges senere i livet.
On the other hand, there are currently no reports on Hepatitis B breakthrough cases after Hexavac vaccination, considering that the EU is a low endemic region and individual risks would potentially increase only later in life.
Ikke desto mindre mener CHMP i henhold til den aktuelle viden, at hepatitis B- vacciner til børn skal være så immunogene som muligt, hvilket nødvendiggør en enkelt maksimumbooster- dosis i pubertetsalderen for at sikre en beskyttende effekt på det tidspunkt, hvor vaccinerede patienter muligvis udsættes for en højere infektionsrisiko i forhold til spædbørnsalderen og barndommen.
Nevertheless, in accordance with the current knowledge, the CHMP considers that childhood Hepatitis B vaccines should be as immunogenic as possible necessitating a maximum of a single booster dose during adolescence to ensure protective efficacy at the time vaccinated subjects might be exposed to a higher risk of infection compared to infancy and childhood.
Indehaveren af markedsføringstilladelsen bekræftede sin forpligtelse til at etablere en test, som kan skelne mellem Hexavac- partier, som har udvist en god immunrespons og en utilstrækkelig immunrespons under kliniske forsøg.
The MAH reiterated their commitment to establish a test to discriminate batches of Hexavac which have elucidated a good vs. an insufficient immune response during clinical trials.
Desuden foreslog indehaveren af markedsføringstilladelsen, at produktoplysningerne ændres, særligt vedrørende separat administration af pneumokok - og meningokok- konjugatvacciner.
Furthermore, the MAH has proposed to change the Product Information (PI), namely separate administration of pneumococcal and meningococcal conjugate vaccines.
Der arbejdes fortløbende på at forbedre immunogeniciteten af Hexavacs HepB- komponenten.
Continuous efforts are being made to improve the immunogenicity of the HepB component of Hexavac.
Desuden var de foreslåede ændringer til ordlyden i produktoplysningerne utilstrækkelige til fuldt ud at redegøre for de negative konsekvenser ved HepB - effekten, der skyldes variationer i fremstillingsprocessen.
Furthermore, the proposed amendments to the PI wording were insufficient to adequately address negative consequences on HepB efficacy resulting from variances in the manufacturing process.
CHMP overvejede generelt den multifaktorelle art af den lave immunogenicitet af Hexavacs HepB - komponent.
Overall, the CHMP considered the multifactorial nature of the low immunogenicity of the HepB component in Hexavac.
Der blev henvist til den stærkt svingende kvalitet af HepB- komponenten i Hexavac, som viser sig under en fremstillingsproces, hvor hovedårsagen til den lave immunogenicitet ikke er blevet identificeret.
Reference was made to the highly variable quality of the HepB component contained in Hexavac emerging from a manufacturing production in which the root cause of the low immunogenicity has failed to be identified.
Disse fakta blev sat i det rette perspektiv med de kliniske konsekvenser, der er observeret indtil nu, og de tydelige få fordele samt usikkerheder, der er forbundet med hepatitis B- vaccination med Hexavac for målpopulationen.
These facts were put into perspective with the clinical consequences observed so far and the apparent low benefits and uncertainties obtained from the Hepatitis B vaccination utilising Hexavac for the target population.
Hvis der tages højde for de data, der foreligger om lav immunogenicitet i dag, har CHMP identificeret en mulig risiko, som er forbundet med fortsat vaccination med Hexavac, hvad angår langtidsbeskyttelse mod hepatitis B- infektion og patientens booster- evne efter priming med Hexavac.
Considering the data on low immunogenicity available today, the CHMP identified a potential risk associated to continued vaccination with Hexavac, in terms of long-term protection against Hepatitis B infection and subject boostability post priming with Hexavac.
CHMP identificerede, at den nedsatte immunogenicitet af den HepB- komponent, som er frigivet af indehaveren af markedsføringstilladelsen, skyldes variabiliteten i produktionsprocessen for denne komponent.
The CHMP identified that the decreased immunogeniticy of the HepB component released by the MAH seems to be due to variability in the production process for this component.
CHMP medtog i sine overvejelser, at der findes kliniske alternativer, dvs. seksvalente vacciner eller tilsvarende kombinationsvacciner, som indeholder de samme komponenter som Hexavac.
The CHMP considered that clinical alternatives exist, i. e. hexavalent vaccines or equivalent combinations of vaccines containing the same components as Hexavac.
Når der tages højde for alle fremsatte synspunkter, herunder de tidslinjer, der er nødvendige for at gennemføre en fuldstændig undersøgelse af alle de problemer, der er forbundet med en lav HepB - immunogenicitet efter vaccination med Hexavac, anbefaler CHMP, at markedsføringstilladelsen for Hexavac suspenderes.
Considering all points raised, including time lines required to fully explore all issues related to low HepB immunogenicity following vaccination with Hexavac, the CHMP recommended the suspension for the Marketing Authorisation of Hexavac.
2 BEGRUNDELSER FOR SUSPENSION AF MARKEDSFØRINGSTILLADELSEN FOR HEXAVAC
2 GROUNDS FOR SUSPENSION OF THE MARKETING AUTHORISATION OF HEXAVAC
• Hvis der tages højde for de data, der foreligger om lav immunogenicitet i dag, har CHMP identificeret en mulig risiko, som er forbundet med fortsat vaccination med Hexavac, hvad angår langtidsbeskyttelse mod hepatitis B- infektion og patientens booster- evne efter priming med Hexavac.
• Considering the data on low immunogenicity available today, the CHMP identified a potential risk associated to continued vaccination with Hexavac, in terms of long-term protection against Hepatitis B infection and subject boostability post priming with Hexavac.
• CHMP identificerede, at den nedsatte immunogenicitet af den HepB- komponent, som er frigivet af indehaveren af markedsføringstilladelsen, skyldes variabiliteten i produktionsprocessen for denne komponent.
• The CHMP identified that the decreased immunogeniticy of the HepB component released by the MAH seems to be due to variability in the production process for this component.
• CHMP medtog i sine overvejelser, at benefit/ risk- forholdet for Hexavac til primærvaccination og booster- vaccination af børn mod difteri, stivkrampe, kighoste, hepatitis B, forårsaget af alle kendte virussubtyper, børnelammelse og invasive infektioner, forårsaget af Haemophilus influenzae type b, ikke var gunstigt.
• The CHMP considered that the benefit/ risk balance of Hexavac for primary and booster vaccination of children against diphtheria, tetanus, pertussis, Hepatitis B caused by all known subtypes of viruses, poliomyelitis and invasive infections caused by Haemophilus influenzae type b, was not favourable.
har CHMP anbefalet, at markedsføringstilladelsen for Hexavac suspenderes.
The CHMP has recommended the suspension of the Marketing Authorisations for Hexavac.
Hvis du ønsker flere oplysninger om din sygdomstilstand eller behandling, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
If you need more information about your medical condition or your treatment, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Humalog er en serie opløsninger og suspensioner til injektion.
Humalog is a range of solutions and suspensions for injection.
Humalog leveres i hætteglas, patroner eller forfyldte penne (Humalog Pen, Humaject).
Humalog is supplied in vials, cartridges or in prefilled pens (Humalog Pen, Humaject).
Humalog indeholder det aktive stof insulin lispro.
Humalog contains the active ingredient insulin lispro.
Humalog- serien omfatter hurtigtvirkende insulinopløsninger (Humalog), længerevirkende insulinsuspensioner (Humalog NPL) og kombinationer af disse to i forskellige blandingsforhold (Humalog Mix):
The Humalog range comprises fast-acting insulin solutions (Humalog), longer-acting insulin suspensions (Humalog NPL), and combination of both in various proportions (Humalog Mix):
Humalog: insulin lispro- opløsning Humalog NPL: insulin lispro protamin- suspension Humalog Mix25:
Humalog: insulin lispro solution Humalog NPL: insulin lispro protamine suspension Humalog Mix25:
25% insulin lispro- opløsning og 75% insulin lispro protamin- suspension Humalog Mix50:
25% insulin lispro solution and 75% insulin lispro protamine suspension Humalog Mix50:
50% insulin lispro- opløsning og 50% insulin lispro protamin- suspension
50% insulin lispro solution and 50% insulin lispro protamine suspension
Humalog anvendes til behandling af voksne og børn med diabetes, der har brug for insulin til at holde deres blodsukker under kontrol, herunder patienter, hvis diabetes lige er konstateret.
Humalog is used to treat adults and children who have diabetes and need insulin to keep their blood sugar level controlled, including those patients whose diabetes has just been diagnosed.
Medicinen udleveres kun mod recept.
The medicine is only available with a prescription.
Humalog, Humalog NPL og Humalog Mix kan gives subkutant (under huden) ved injektion i overarmene, lårene, ballerne eller abdomen (maveregionen).
Humalog, Humalog NPL and Humalog Mix may be given subcutaneously (under the skin) by injection into the upper arms, thighs, buttocks, or abdomen (tummy).
Humalog kan også gives ved konstant infusion ved hjælp af en insulinpumpe eller intravenøst (i en vene).
Humalog may also be given by continuous infusion using an insulin pump or intravenously (into a vein).
Humalog - og Humalog Mix - produkterne gives normalt umiddelbart inden et måltid og kan gives umiddelbart efter et måltid, hvis det er nødvendigt.
Humalog and Humalog Mix products are normally given shortly before a meal and may be given soon after a meal if necessary.
Humalog kan anvendes sammen med en længerevirkende insulin eller orale diabetes- lægemidler (sulfonylurea).
Humalog can be used with a longer-acting insulin or oral diabetic medicines (sulphonylureas).
Humalog NPL kan blandes med eller gives sammen med Humalog.
Humalog NPL can be mixed with or given in conjunction with Humalog.
Diabetes er en sygdom, hvor kroppen ikke producerer tilstrækkeligt insulin til at styre blodsukkerniveauet.
Diabetes is a disease in which the body does not produce enough insulin to control the level of blood sugar.
Humalog er en insulinerstatning, der i høj grad svarer til den insulin, der produceres i bugspytkirtlen.
Humalog is a replacement insulin which very similar to the insulin made by the pancreas.
Det aktive stof i Humalog, insulin lispro, fremstilles ved hjælp af en metode, der kaldes 'rekombinant DNA- teknologi'.
The active ingredient of Humalog, insulin lispro, is produced by a method known as ‘ recombinant DNA technology’.
Det fremstilles af en bakterie, der har modtaget et 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Insulin lispro products are available in various forms: as Humalog in the soluble form, which acts 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Insulin lispro afviger kun lidt fra human insulin, og ændringen betyder, at det absorberes hurtigere af kroppen og derfor kan virke hurtigere end almindelig human insulin.
(44-20) 74 18 84 00 Fax (44-20) 74 18 86 68 E-mail: mail@emea. eu. int http: / /www. emea. eu. int ©EMEA 2006 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged quickly (more or less immediately after injection), and as Humalog NPL in the protamine suspension form which is absorbed much more slowly during the day; and give a longer duration of action.
Humalog Mix er en blanding af disse to formler.
Humalog Mix is a mixture between these both formulations.
Erstatningsinsulin virker på samme måde som naturligt produceret insulin og hjælper glukosen med at trænge ind i cellerne fra blodet.
The replacement insulin acts in same way as naturally produced insulin and helps glucose enter cells from the blood.
Ved at holde bloksukkeret under kontrol mindskes sukkersygesymptomerne og – komplikationerne.
By controlling the level of blood sugar, the symptoms and complications of diabetes are reduced.
Hvordan er Humalog blevet undersøgt?
How has Humalog been studied?
Humalog blev først undersøgt i 8 kliniske undersøgelser med 2951 diabetespatienter med diabetes type 1 eller 2.
Humalog was originally studied in eight clinical trials including 2951 diabetic patients with type 1 or type 2 diabetes.
Virkningen af Humalog blev sammenlignet med Humulin R (en opløselig rekombinant DNA human insulin) ved tilsætning til en eller to daglige doser langtidsvirkende insuliner.
The effectiveness of Humalog was compared to Humulin R (a soluble recombinant DNA human insulin), when added to one or two daily doses of long-acting insulins.
Forsøgene målte niveauerne for glykosyleret hæmoglobin (HbA1c), der indikerer, hvor godt blodets glukose styres, samt fastende glukoseniveauer.
The studies measured the level of glycosylated haemoglobin (HbA1c), which gives an indication of how well the blood glucose is controlled, and fasting glucose levels.
Der blev gennemført yderligere undersøgelser, hvor brugen af Humalog hos 542 børn og unge (i alderen 2 til 19) og brugen af Humalog i kombination med sulfonylurea (orale lægemidler mod sukkersyge) blev undersøgt.
Further studies were also done looking at the use of Humalog in 542 children and adolescents (aged 2 to 19), and the use of Humalog in combination with sulphonylureas (oral anti-diabetes medicines).
Der var ingen statistiske forskelle mellem Humalog og Humulin med hensyn til regulering af diabetes målt ved glykosyleret hæmoglobin eller fastende glukoseniveauer.
There were no statistical differences between Humalog and Humulin on diabetic control measured by glycosylated haemoglobin or fasting glucose levels.
Humalog kan medføre hypoglykæmi (lavt blodsukker).
Humalog may cause hypoglycaemia (low blood glucose).
Den fuldstændige liste over de indberettede bivirkninger ved Humalog fremgår af indlægssedlen.
For the full description of the side effects reported with Humalog, please see the Package Leaflet.
Humalog må ikke anvendes af personer, der kan være overf' ølsomme over for nogen af indholdsstofferne.
Humalog should not be used in people who may be hypersensitive to any of the ingredients.
Det kan være nødvendigt at justere Humalog- doserne, når midlet gives sammen med en række andre lægemidler, der kan påvirke blodsukkeret (den fuldstændige liste fremgår af indlægssedlen).
Humalog doses might also need to be adjusted when given with a number of other medicines which may have an effect on blood sugar (the full list is available in the Package Leaflet).
Humalog Mix eller Humalog NPL må under ingen omstændigheder gives intravenøst.
Under no circumstances should Humalog Mix or Humalog NPL be given intravenously.
Hvorfor er Humalog blevet godkendt?
Why has Humalog been approved?
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at fordelene ved Humalog er større end risiciene ved behandling af diabetes mellitus.
The Committee for Medicinal products for Human Use (CHMP) decided that Humalog’ s benefits are greater than its risks for the treatment of diabetes mellitus.
Udvalget anbefalede udstedelse af markedsføringstilladelse for Humalog.
They recommended that Humalog be given marketing authorisation.
Andre oplysninger om Humalog:
Other information about Humalog:
Europa- Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Humalog til Eli Lilly Netherland B. V. den 30. april 1996.
The European Commission granted marketing authorisations valid throughout the European Union, for Humalog to Eli Lilly Netherland B. V. on 30 April 1996.
Markedsføringstilladelsen blev forlænget den 30. april 2001.
This was renewed on 30 April 2001.
Den fuldstændige EPAR for Humalog findes her.
The full EPAR for Humalog is available here.
Dette sammendrag blev sidst ajourført i 1 - 2006
This summary was last updated in 1-2006
Intravenøs anvendelse eller Hætteglas Subkutan anvendelse
Subcutaneous or intravenous use
Intravenøs anvendelse eller Cylinderampul Subkutan anvendelse
Subcutaneous or intravenous use
Humalog Mix25 100 E/ ml
100 U/ ml
Humalog Mix50 100 E/ ml
100 U/ ml
Humalog NPL 100 E/ ml
100 U/ ml
Humalog - 100 E/ ml Humaject
100 U/ ml
5 fyldte penne
5 pens
Humalog Pen 100 E/ ml
100 U/ ml
Humalog Mix25 100 E/ ml Pen
100 U/ ml
Humalog Mix50 100 E/ ml Pen
100 U/ ml
Humalog NPL 100 E/ ml Pen
100 U/ ml
Humalog 100 E/ ml
100 U/ ml
5 x 1 hætteglas
5 x 1 vial
2x5 cylinderampuller
2 x 5 cartridges
1/ 3 EU- nummer
1/ 2 EU/ 1/ 96/ 007/ 025
Indgivelsesvej
Humalog Mix50
2 x 5 fyldte penne
2x 5 pens
2 x 5 fyldte penne
2 x 5 pens
Humalog 100 E/ ml KwikPen
100 U/ ml
Humalog Mix25 100 E/ ml KwikPen
100 U/ ml
Humalog Mix50 100 E/ ml KwikPen
100 U/ ml
Humalog NPL 100 E/ ml KwikPen
100 U/ ml
Humalog 100 E/ ml, injektionsvæske, opløsning, i hætteglas
Humalog 100 U/ ml, solution for injection in vial
En ml indeholder 100 E (svarende til 3, 5 mg) insulin lispro (afledt af rekombinant DNA produceret i E. coli).
One ml contains 100U (equivalent to 3.5mg) insulin lispro (recombinant DNA origin produced in E. coli).
Til behandling af voksne og børn med diabetes mellitus, der kræver insulin til opretholdelse af normal glukose homøostase.
For the treatment of adults and children with diabetes mellitus who require insulin for the maintenance of normal glucose homeostasis.
4. 2), men kan også gives som intramuskulær injektion, hvilket dog ikke anbefales.
Humalog preparations should be given by subcutaneous injection or by continuous subcutaneous infusion pump (see section 4.2) and may, although not recommended, also be given by intramuscular injection.
Dette kan f. eks. være for at kontrollere blodglukoseniveauet under en ketoacidose, i forbindelse med akut sygdom eller under/ efter en operation.
If necessary, Humalog may also be administered intravenously, for example; for the control of blood glucose levels during ketoacidosis, acute illnesses or during intra and post operative periods.
1 gang pr. måned.
Use of injection sites should be rotated so that the same site is not used more than approximately once a month.
Humalog har en hurtigt indsættende virkning og en kortere virkningsvarighed (2- 5 timer), ved subkutan injektion, end opløselig insulin.
Humalog takes effect rapidly and has a shorter duration of activity (2 to 5 hours) given subcutaneously as compared with regular insulin.
I samråd med en læge må Humalog bruges sammen med længerevirkende human insulin eller orale sulfonylurinstoffer.
Humalog can be used in conjunction with a longer-acting human insulin or oral sulphonylurea agents, on the advice of a physician.
2 Brug af Humalog i en insulin infusionspumpe:
2 Use of Humalog in an insulin infusion pump:
Kun visse CE- mærkede insulininfusionspumper kan anvendes til infusion af insulin lispro.
Only certain CE-marked insulin infusion pumps may be used to infuse insulin lispro.
Skift infusionssæt for hver 48 timer.
Change the infusion set every 48 hours.
Brug aseptisk teknik, når infusionssættet isættes.
Use aseptic technique when inserting the infusion set.
Hvis der forekommer gentagne eller svært nedsatte blodglukosekoncentrationer, bør lægen eller diabetessygeplejersken informeres, og nødvendigheden af at reducere eller stoppe insulininfusionen bør overvejes.
If repeated or severe low blood glucose levels occur, notify your health care professional and consider the need to reduce or stop your insulin infusion.