natgillin/translations-raw huggingface dataset:
Følgende benævnelser anvendes: Meget almindelige (≥1/10), almindelige (≥1/100 til til <1/10), ikke almindelige (≥1/1.000 til <1/100), sjældne (≥1/10.000 til <1/1.000), meget sjældne (<1/10.000) og ikke kendte (kan ikke estimeres ud fra forhåndenværende data).
Undesirable effects ranked under headings of frequency are listed below, 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), not known (cannot be estimated from the available data).
Den samlede udskillelse i urinen udgør ca. 90% af dosis.
The overall urinary excretion accounts for about 90% of the dose.
Hvis du er under 18 år, anbefales det ikke, at du tager Rilutek, da der ikke er nogen information tilgængelig for denne patientgruppe.
If you are less than 18 years of age, the use of RILUTEK is not recommended because there is no information available in this population.
Rilutek forhindrer frigivelsen af glutamat og dette kan hjælpe med at forebygge, at nerveceller bliver ødelagt.
RILUTEK stops the release of glutamate and this may help in preventing the nerve cells being damaged.
Riluzol er ca. 97% proteinbundet og bindes hovedsageligt til serumalbumin og lipoproteiner.
Riluzole is about 97% protein bound and it binds mainly to serum albumin and to lipoproteins.
Hastigheden og graden af absorption reduceres, når riluzol gives med fedtholdige måltider (fald i Cmax på 44%, fald af AUC på 17%).
The rate and extent of absorption is reduced when riluzole is administered with high-fat meals (decrease in Cmax of 44%, decrease in AUC of 17%).
Derfor bør RILUTEK ikke bruges til patienter med andre former af motor-neuronsygdomme.
Therefore, RILUTEK should not be used in patients with any other form of motor neurone disease.
Få mere information hos din læge om ALS, og hvorfor du får denne medicin
Please consult your doctor for more information about ALS and the reason why this medicine has been prescribed for you.
Patienter bør advares om muligheden for at blive svimle eller omtågede, og de bør opfordres til ikke at køre bil eller betjene maskiner, hvis disse symptomer opstår.
Patients should be warned about the potential for dizziness or vertigo, and advised not to drive or operate machinery if these symptoms occur.
Terapeutisk klassifikation: Centralnervesystemet, øvrige lægemidler, ATC kode: N07XX02
Pharmacotherapeutic group: other nervous system drugs, ATC code: N07XX02.
Med udgangspunkt i de farmakokinetiske undersøgelser, er der ingen særlige anvisninger for brug af RILUTEK i denne patientgruppe.
Based on pharmacokinetic data, there are no special instructions for the use of RILUTEK in this population.
Rilutek fås i en pakning af 56 tabletter til oral anvendelse.
RILUTEK is available in a pack of 56 tablets to be taken orally.
RILUTEK er ikke vist at være effektiv i behandlingen af de sene stadier af ALS.
RILUTEK has not been shown to be effective in the late stages of ALS.
Kontakt straks din læge - Hvis du får nogen form for feber (forhøjet temperatur), da Rilutek kan medføre nedsættelse af antallet af hvide blodlegemer.
Tell your doctor immediately if you experience any fever (increase in temperature) because RILUTEK may cause a decrease in the number of white blood cells.
Behandling med RILUTEK bør kun iværksættes af speciallæger med erfaring i behandling af motorneuronsygdomme.
Treatment with RILUTEK should only be initiated by specialist physicians with experience in the management of motor neurone diseases.
Rilutek indeholder
What RILUTEK contains
VIGTIGT
IMPORTANT
Der er intet bevis for, at RILUTEK udviser terapeutisk effekt på den motoriske funktion, på lungefunktion, facikulationer, muskelstyrke og motoriske symptomer.
There is no evidence that RILUTEK exerts a therapeutic effect on motor function, lung function, fasciculations, muscle strength and motor symptoms.
RILUTEK anbefales ikke til pædiatriske patienter, pga. manglende data vedrørende riluzols sikkerhed og virkning ved neurodegenerative sygdomme hos børn og unge.
RILUTEK is not recommended for use in paediatric population, due to a lack of data on the safety and efficacy of riluzole in any neurodegenerative diseases occurring in children or adolescents.
Sanofi Mature IP 54 rue La Boétie 75008 Paris Frankrig
Sanofi Mature IP 54 rue La Boétie 75008 Paris France
Tabletten er kapselformet, hvid og mærket ”RPR 202” på den ene side.
The tablets are capsule-shaped, white and engraved with “RPR 202” on one side.
Det skal du vide, før du begynder at tage Rilutek
What you need to know before you take RILUTEK
- Hvis du får hoste eller besvær med at trække vejret, da dette kan være tegn på en lungesygdom (som hedder interstitiel lungesygdom).
if you experience cough or difficulties in breathing, as this may be a sign of lung disease (called interstitial lung disease).
Administration Oral anvendelse
Method of administration Oral use
Hvad Riluteker Det aktive indholdsstof i Riluteker riluzol, som virker på nervesystemet.
The active substance in RILUTEK is riluzole which acts on the nervous system.
Kliniske undersøgelser har vist, at RILUTEK forlænger overlevelsen for patienter med ALS (se pkt.
Clinical trials have demonstrated that RILUTEK extends survival for patients with ALS (see section 5.1).
Du kan køre bil og anvende værktøj og maskiner, når du tager Rilutek, medmindre du føler dig svimmel eller omtåget.
You can drive or use any tools or machines, unless you feel dizzy or light headed after taking this medicine.
Brug af anden medicin sammen med Rilutek Fortæl altid lægen eller apotekspersonalet, hvis du tager anden medicin eller har gjort det for nylig.
Other medicines and RILUTEK Tell your doctor if you are taking, have recently taken or might take any other medicines.
Filmovertrukken tablet.
Film-coated tablet
Hvis der opstår respiratoriske symptomer som tør hoste og/eller dyspnø, bør der tages et røgtenbillede af brystkassen, og ved tegn på eventuelle interstitielle lungesygdomme (f.eks. bilaterale diffuse lungeinfiltrater) bør behandling med riluzol seponeres øjeblikkeligt.
If respiratory symptoms develop such as dry cough and/or dyspnoea, chest radiography should be performed, and in case of findings suggestive of interstitial lung disease (e.g. bilateral diffuse lung opacities), riluzole should be discontinued immediately.
Hver tablet indeholder 50 mg riluzol og har ”RPR 202” præget på den ene side af tabletten.
Each tablet contains 50 mg of riluzole and is engraved with “RPR 202” on one side.
RILUTEK anvendes for at forlænge livet eller tiden indtil mekanisk ventilation hos patienter med amyotrofisk lateral sclerose (ALS).
RILUTEK is indicated to extend life or the time to mechanical ventilation for patients with amyotrophic lateral sclerosis (ALS).
Sanofi-aventis France
France sanofi-aventis France
Hvis du har glemt at tage Rilutek Du må ikke tage en dobbeltdosis som erstatning for den glemte dosis.
Do not take a double dose to make up for a forgotten tablet.
Sanofi Winthrop Industrie 56, Route de Choisy au Bac, 60205 Compiègne Frankrig
Sanofi Winthrop Industrie 56, Route de Choisy au Bac 60205 Compiègne France
Meget almindelige bivirkninger (kan forekomme hos flere end 1 ud af 10 personer) af Riluteker: - Træthed - Kvalme - Forføjet niveau af nogle enzymer (aminotransferaser) i blodet.
Very common side effects (may affect more than 1 in 10 people) of RILUTEK are: tiredness feeling sick increased blood levels of some enzymes of the liver (transaminases).
Indehaver af markedsføringstilladelsen Sanofi Mature IP
Marketing Authorisation Holder Sanofi Mature IP
Hvad Rilutekanvendes til Rilutekanvendes til patienter med amyotrofisk lateral sclerose (ALS).
RILUTEK is used in patients with amyotrophic lateral sclerosis (ALS).
I et dobbelt-blindt placebo kontrolleret studie, der var designet til at undersøge effekt og sikkerhed hos japanske patienter, blev 204 patienter randomiseret til enten 100 mg riluzol/dag (50 mg 2 gange daglig) eller placebo.
In a double-blind placebo-controlled trial designed to assess the efficacy and safety of riluzole in Japanese patients, 204 patients were randomised to riluzole 100 mg/day (50 mg twice daily) or placebo and were followed-up for 18 months.
Sanofi-aventis Norge AS Tlf: +47 67 10 71 00
Norge sanofi-aventis Norge AS Tlf: +47 67 10 71 00
Sanofi-aventis Ireland Ltd. T/A SANOFI Tel: +353 (0) 1 403 56 00
Ireland sanofi-aventis Ireland Ltd. T/A SANOFI Tel: +353 (0) 1 403 56 00
Graviditet, amning og frugtbarhed Du må ikke tage Rilutek, hvis du er gravid eller ammer, eller har mistanke om, at du er gravid.
You MUST NOT take RILUTEK if you are or think you may be pregnant, or if you are breast-feeding.
RILUTEK kan ikke anbefales til patienter med nedsat nyrefunktion, da der ikke er foretaget undersøgelser med gentagne doseringer hos denne patientgruppe (se pkt.
RILUTEK is not recommended for use in patients with impaired renal function, as studies at repeated doses have not been conducted in this population (see section 4.4).
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Κύπρος sanofi-aventis Cyprus Ltd. Τηλ: +357 22 871600
Sanofi-aventis Estonia OÜ Tel: +372 627 34 88
Eesti sanofi-aventis Estonia OÜ Tel: +372 627 34 88
Hvis du har taget for mange Rilutek Hvis du har taget for mange tabletter, skal du straks kontakte læge eller skadestue.
If you take too many tablets, contact your doctor or the nearest hospital emergency department immediately.
Sanofi-aventis AEBE Τηλ: +30 210 900 16 00
Ελλάδα sanofi-aventis AEBE Τηλ: +30 210 900 16 00
Sanofi-aventis Latvia SIA Tel: +371 67 33 24 51
Latvija sanofi-aventis Latvia SIA Tel: +371 67 33 24 51
NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Sanofi Mature IP
NAME OF THE MARKETING AUTHORISATION HOLDER Sanofi Mature IP
Sanofi-aventis, S.A. Tel: +34 93 485 94 00
España sanofi-aventis, S.A. Tel: +34 93 485 94 00
- Hvis du får nogen af følgende symptomer: Gulfarvning af huden eller det hvide i øjnene (gulsot), kløe over hele kroppen, du føler dig syg, eller kaster op, da dette kan være tegn på leverbetændelse (hepatitis).
if you experience any of the following symptoms: yellowing of your skin or the white of your eyes (jaundice), itching all over, feeling sick, being sick, as this may be signs of liver disease (hepatitis).Your doctor may do regular blood tests while you are taking RILUTEK to make sure that this does not occur.
Nedsat nyrefunktion Der ikke udført undersøgelser med gentagne doseringer hos patienter med nedsat nyrefunktion (se pkt.
Renal impairment Studies at repeated doses have not been conducted in patients with impaired renal function (see section
Overtræk:
Core:
Almindelige bivirkninger (kan forekomme hos op til 1 ud af 10 personer) af Riluteker: Svimmelhed
Uncommon side effects (may affect up to 1 in 100 people) of RILUTEK are:
Hvis du har mistanke om, du er gravid, eller hvis du overvejer at amme, skal du diskutere det med din læge.
If you think you may be pregnant, or if you intend to breast-feed, ask your doctor for advice before taking RILUTEK.
theophyllin, amitriptylin, og quinoloner) kan potentielt nedsætte riluzols eliminations-hastighed, hvorimod stoffer, der fremmer CYP1A2 (f.eks. cigaretrygning, grillmad, rifampicin og omeprazol) kan øge eliminationshastigheden af riluzol.
Inhibitors of CYP 1A2 (e.g. caffeine, diclofenac, diazepam, nicergoline, clomipramine, imipramine, fluvoxamine, phenacetin, theophylline, amitriptyline and quinolones) could potentially decrease the rate of riluzole elimination, while inducers of CYP 1A2 (e.g. cigarette smoke, charcoal-broiled food, rifampicin and omeprazole) could increase the rate of riluzole elimination.
RILUTEK er kontraindiceret under graviditeten (se pkt.
RILUTEK is contraindicated in pregnancy (see sections 4.3 and 5.3).
ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Læs indlægssedlen inden brug.
LIST OF EXCIPIENTS PHARMACEUTICAL FORM AND CONTENTS 56 film-coated tablets METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use.
Sådan skal du tage Rilutek
How to take RILUTEK
Rilutek 50 mg, filmovertrukne tabletter Riluzol
RILUTEK 50 mg film-coated tablets Riluzole
SÆRLIG ADVARSEL OM, AT LÆGEMIDLET SKAL OPBEVARES UTILGÆNGELIGT FOR BØRN
Oral use SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN Keep out of the sight and reach of children.
Sanofi-aventis Croatia d.o.o.
Hrvatska sanofi-aventis Croatia d.o.o.
LÆGEMIDLETS NAVN RILUTEK 50 mg filmovertrukne tabletter riluzol
NAME OF THE MEDICINAL PRODUCT RILUTEK 50 mg film-coated tablets riluzole
Tag ikke Rilutek - hvis du er allergisk over for riluzol eller et af de øvrige indholdsstoffer i Rilutek (angivet i punkt 6).
Do not take RILUTEK if you are allergic to riluzole or any of the other ingredients of this medicine (listed in section if you have any liver disease or increased blood levels of some enzymes of the liver (transaminases), if you are pregnant or breast-feeding.
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER En filmovertrukken tablet indeholder 50 mg riluzol
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON NAME OF THE MEDICINAL PRODUCT RILUTEK 50 mg film-coated tablets riluzole STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 50 mg of riluzole.
RILUTEK er kontraindiceret til ammende kvinder (se pkt.
RILUTEK is contraindicated in breast-feeding women (see sections 4.3 and 5.3).
Sanofi-aventis d.o.o.
Slovenija sanofi-aventis d.o.o.
Det skal du vide, før du begynder at tage Rilutek Sådan skal du tage Rilutek Bivirkninger
What RILUTEK is and what it is used for What you need to know before you take RILUTEK How to take RILUTEK
Sanofi-aventis Sp. Z o.o.
Polska sanofi-aventis Sp. z o.o.
ANVENDT LÆGEMIDDEL SAMT AFFALD HERAF 11.
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
Ikke almindelige (kan forekomme hos op til 1 ud af 100 personer) af Riluteker: - Blodmangel - Allergiske reaktioner - Betændelse i bugspytkirtlen (pancreatitis).
Common side effects (may affect up to 1 in 10 people) of RILUTEK are: dizziness numbness or tingling of the mouth vomiting sleepiness increase in heart beat diarrhoea headache abdominal pain pain
Sikkerhed og effekt af RILUTEK ved andre motor-neuronsygdomme end ALS er ikke undersøgt.
Safety and efficacy of RILUTEK has only been studied in ALS.
Mave-tarm-kanalen Kvalme
Impaired hepatic function
Kontakt lægen, før du tager Rilutek: - hvis du har nogen form for leverproblemer: gulfarvning af huden eller det hvide i dine øjne
Warnings and precautions Talk to your doctor before taking RILUTEK: if you have any liver problems: yellowing of your skin or the white of your eyes (jaundice), itching all over, feeling sick, being sick if your kidneys are not working very well if you have any fever: it may be due to a low number of white blood cells which can cause an increased risk of infection If any of the above applies to you, or if you are not sure, tell your doctor who will decide what to do.
Prikken i munden
Liver impairment
Benefit/risk-vurdering
Benefit/risk assessment
REVURDERING AF CHMP'S UDTALELSE AF 23. APRIL 2009
RE-EXAMINATION OF THE CHMP OPINION ADOPTED ON 23 APRIL 2009
VIDENSKABELIGE KONKLUSIONER
SCIENTIFIC CONCLUSIONS
BILAG II VIDENSKABELIGE KONKLUSIONER OG BEGRUNDELSER FOR AFSLAG
ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR REFUSAL
- Sikkerhedsprofilen for ciclosporin er også kritisk.
-The safety profile of ciclosporin is also critical.
BILAG III BETINGELSER FOR OPHÆVELSE AF SUSPENDERINGEN AF MARKEDSFØRINGSTILLADELSERNE
ANNEX III CONDITION FOR THE LIFTING OF THE MARKETING AUTHORISATIONS SUSPENSION
Som en del af den kliniske rutinemæssige praksis udføres monitorering af terapeutiske lægemidler med henblik på at kontrollere og overvåge sikkerheden.
In clinical routine practice therapeutic drug monitoring is done in order to control for and monitor safety.
Sammendrag af begrundelserne for revurdering
Summary of Grounds for Re-Examination
BILAG I FORTEGNELSE OVER LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORM, STYRKE, INDGIVELSESVEJ, ANSØGER/INDEHAVER AF MARKEDSFØRINGSTILLADELSE I MEDLEMSSTATERNE
ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANT / MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES
Referencelægemidlet, som er godkendt i Tyskland, er: Sandimmun Optoral 25 mg Kapseln.
The Reference medicinal product authorised in Germany is: Sandimmun Optoral 25 mg Kapseln.
Under den gensidige anerkendelsesprocedure (NL/H/1402/001-003/MR) blev der givet udtryk for betænkeligheder grundet potentiel alvorlig risiko for folkesundheden af følgende grunde: Der er ikke påvist tilstrækkelig bioækvivalens.
In the MRP procedure (NL/H/1402/001-003/MR) potential serious risk for public health concern was raised on the following grounds: bioequivalence has not been sufficiently demonstrated.
2) CHMP's andet punkt var, om det samme godkendelsesinterval (enten normalt eller snævert) burde anvendes for både AUC og Cmax.
2) The second question raised by CHMP was whether the same acceptance range (either normal or narrowed) should be applied both for AUC and Cmax.
Ciclosporin er indiceret til transplantation (f.eks. forebyggelse eller behandling af afstødning ved transplantation af solide organer, knoglemarvstransplantation, graft versus host-sygdom) og autoimmune sygdomme (f.eks. nefrotisk syndrom, rheumatoid arthritis, psoriasis, atopisk dermatitis).
Ciclosporin is indicated in transplantation (e.g. prevention or treatment of rejection of solid organ transplantation, bone marrow transplantation, graft-versus-host-disease) and auto-immune diseases (e.g nephrotic syndrome, rheumatoid arthritis, psoriasis, atopic dermatitis).
Forskelle i Cmax blev betragtet som mindre væsentlige, da det maksimale niveau kun opretholdes i en kort periode, mens AUC udgør den samlede eksponering for lægemidlet, men det blev besluttet, at det normale interval skulle anvendes.
Differences in Cmax were considered less important, because a peak level is maintained for only a short period of time, whereas AUC represents the total exposure to the drug, but it was felt that the conventional range should be used.
Navnlig en øvre grænse for konfidensintervallet til sammenligning af Cmax var uden for selv det normale godkendelsesinterval.
In particular the upper confidence limit for the comparison of Cmax was outside even the standard acceptance range.
4) CHMP's fjerde punkt drejede sig om kostens indvirkningen på ciclosporin.
4) The fourth issue raised by CHMP was about the food effect on ciclosporin.
Desuden anbefales det i vejledningen til transplanterede patienter (University of Southern CaliforniaCardiothoracic Surgery and Pancreas Transplant Program), at ciclosporin tages inden et måltid for at opnå bedre absorption i maven.
In addition, in the Transplant Patient Guide (University of Southern California-Cardiothoracic Surgery and Pancreas Transplant Program), it is recommended to take ciclosporin before meals, for better absorption by the stomach.
Forfatterne fandt, at både cyclosporin og tacrolimus var "critical-dose drugs".
The authors considered both cyclosporine and tacrolimus to be critical-dose drugs.
Dette spørgsmål drejer sig tydeligvis ikke om substituerbarhed mellem Sandimmun og dets optimerede formulering af Neoral, men om manglende dokumentation for bioækvivalens, da dette er en generisk procedure.
The issue here is clearly not a problem of interchangeability between Sandimmune and its optimized formulation of Neoral, but a lack of proof of bioequivalence, since this is a generic procedure.
Referencemedlemsstaten, Nederlandene, vil vurdere data fra en ny bioækvivalensundersøgelse, og hvis de følgende betingelser opfyldes, kan suspenderingen af markedsføringstilladelserne ophæves.
The RMS, the Netherlands, will assess data from a new bioequivalence study and, if the following condition is fulfilled and satisfactory data provided, the suspension of the Marketing Authorisations can be lifted:
Det snævre interval bør anvendes for både AUC og Cmax, da værdier uden for intervallet kan medføre uønskede konsekvenser i forhold til virkning og/eller sikkerhed for begge disse parametre.
This narrow range should apply to both AUC and Cmax as outside range values for any of both parameters can lead to efficacy and/or safety unwanted consequences.
Den lidt mindre partikelstørrelse for Ciclosporin IDL skal ses som en fordel, hvad angår absorption i forbindelse med fødeindtagelse.
Slightly smaller particles size of Ciclosporin IDL should be seen as an advantage for the absorption regarding food intake.
Bioækvivalens og sikkert skifte
Bioequivalence and safe switch
Indehaveren af markedsføringstilladelsen citerede en publikation fra The National Kidney Foundation fra 1999, der gav udtryk for bekymring om manglende ækvivalens for immunosuppressiv behandling efter organtransplantation og indførte termen "critical-dose drug".
The MAH quoted a publication from The National Kidney Foundation of 1999 raising inequivalence concerns for transplant organ immunosuppressants and introduced the term “critical-dose drug”.
Pointoverslag (%) for test/reference (90 % CI)
Fasting Point estimate (%) for test / reference (90% CI)
Et generisk lægemiddel skal kunne anvendes substituerbart med et originalpræparat uden ekstra forholdsregler.
A generic product should be possible to use interchangeably with an originator product without taking any extra measurements.
CHMP var ikke enigt i, at der ikke var anledning til betænkeligheder vedrørende sikkerheden i fastende tilstand, og godkendte ikke anvendelsen af asymmetriske konfidensintervaller.
The CHMP did not agree upon the lack of safety concerns in fasting conditions and did not endorse the use of asymmetric CIs.
3) CHMP's tredje punkt var, hvorvidt de samme krav skulle gælde ved vurdering af bioækvivalens efter et fedtrigt måltid.
3) The third point raised by CHMP was whether the same set of requirements should be applied for assessing bioequivalence under high-fat fed conditions.
- Ciclosporin betegnes som et "critical-dose drug" med et snævert terapeutisk indeks.
Ciclosporin is considered a ‘critical dose drug' with narrow therapeutic index.
Indehaver af markedsføringstilladelsen Ansøger
Marketing Authorisation Holder
Dette kan medføre store udsving i koncentrationen i blodet, da det er påvist, at kostindtaget har en særdeles negativ indvirkning på optagelsen (op til 30 % reduktion af Cmax og 15 % reduktion af AUC) af referencelægemidlet.
This may result in major swings in blood concentrations, since it has been shown that the intake of food has a very negative effect on absorption (up to about 30% reduction of Cmax and 15% reduction in AUC) of the reference product.
Ved generiske ansøgninger vurderes udelukkende bioækvivalensdata, og derfor bør en godkendelse kun gives, hvor der er sikkerhed for, at en sådan risiko er reduceret mest muligt gennem indsnævring af konfidensintervallet.
For generic applications no other data than bioequivalence is assessed and therefore approval should be based with confidence that such risk is reduced at maximum by narrowing the CI.
Indehaveren af markedsføringstilladelsen anførte, at dette spørgsmål skal behandles af tilsynsmyndighederne og skal tages i betragtning ved evalueringen af IDL-testlægemiddelformuleringen, fordi dette kan spille en afgørende rolle for sikkerhedsproblemer, eftersom effekten under alle omstændigheder blev bevaret, som det fremgår af resultaterne for AUC.
The MAH stated that this issue needs to be addressed by the Regulatory Authorities and should be taken into consideration when evaluating IDL test product formulation, because this could play a definite role for safety issues, knowing that efficacy was preserved in any case as shown by the AUCs results.