natgillin/translations-raw huggingface dataset:
Kvinder skal anvende effektiv prævention, mens de tager Chenodeoxycholic acid Leadiant .
Women should use an effective contraceptive method whilst taking Chenodeoxycholic acid Leadiant.
Dosisberegning (børn 1-12 år, unge 12-18 år og voksne) chenodeoxycholsyre 10 mg/ml suspension Daglig dosis:
Dose calculation (Children 1-12yr, adolescents 12-18yr and adults) chenodeoxycholic acid 10 mg/mL suspension
Chenodeoxycholsyre bør ikke administreres sammen med colestyramin, da det binder chenodeoxycholsyre i tarmen og dermed forhindrer reabsorption og virkning.
Chenodeoxycholic acid should not be administered together with colestyramine as it binds chenodeoxycholic acid in the intestine and thus prevents its reabsorption and efficacy.
Den tilsvarende mængde suspension, der skal gives = 5 mg ∙ 1 ml)/5 mg = 5 ml
The corresponding amount of suspension to give = (5 mg x 1 ml) = 1 ml
I studier med rhesusaber og bavianer blev det påvist, at chenodeoxycholsyre fremkaldte patologiske forandringer i leveren hos det voksende foster hos drægtige dyr (ved en dosis på 5-120 mg/kg/dag hos rhesusaber og 18-38 mg/kg/dag hos bavianer).
In rhesus monkey and baboon studies it was demonstrated that chenodeoxycholic acid dose to pregnant animals (at 5-120 mg/kg/day for rhesus monkey; at 18-38 mg/kg/day for baboons) produced liver pathology in the developing foetus.
Suspensionen vil blive fremstillet på apoteket.
This mixture will be provided to you by your pharmacy.
(Vægt i kg) x (Dosis i mg/kg) = Daglig dosis i mg
(Weight in kg) x (Dose in mg/kg) = Daily dose in mg
Bivirkningerne hos patienter (både voksne og børn), som får chenodeoxycholsyre, er generelt lette til moderate.
Adverse reactions in patients (both adults and children) receiving Chenodeoxycholic acid are generally mild to moderate in severity; the main reactions observed are given in the table below.
Eksogen substitution med chenodeoxycholsyre hæmmer CYP7A1 (via kernereceptoren, FXR) og HMG-CoA-reduktase og genopretter dermed feedbackhæmningen.
Exogenous replacement with Chenodeoxycholic acid inhibits CYP7A1 (via nuclear receptor, FXR) and HMG CoA reductase, thus restoring the feedback inhibition.
Kapselindhold Majsstivelse Magnesiumstearat Silica, kolloidt vandfrit Vand
Capsule contents: maize starch, magnesium stearate, silica colloidal anhydrous, water,
P-piller kan påvirke den måde, Chenodeoxycholic acid Leadiant virker på, og gøre det mindre effektivt.
Oral contraceptives may affect the way in which Chenodeoxycholic acid Leadiant works making it less effective.
Ved behandling med chenodeoxycholsyre hæmmes den endogene syntese af primære galdesyrer, cholsyre og chenodeoxycholsyre.
After treatment with chenodeoxycholic acid, the endogenous synthesis of the primary bile acids, cholic acid and chenodeoxycholic acid, is inhibited.
Samlet daglig dosis = 10 kg x 15 mg/kg = 150 mg
The total daily dose = 10 kg x 15 mg/kg = 150 mg
Administration af orale antikonceptiva mindsker puljen af chenodeoxycholsyre.
The administration of oral contraceptives reduces the pool size of chenodeoxycholic acid.
Chenodeoxycholic acid Leadiant 250 mg hårde kapsler
Chenodeoxycholic acid Leadiant 250 mg hard capsules
Chenodeoxycholic acid Leadiant fås i blisterpakninger med 100 hårde kapsler.
Chenodeoxycholic acid Leadiant is available in blister packs containing 100 hard capsules.
Det aktive stof opløses i natriumhydrogencarbonat-opløsningen, men ikke alle indholdsstofferne i kapslen opløses, hvorfor væsken fremstår som en blanding (en suspension).
The active substance will be dissolved in the sodium bicarbonate solution and as not all the contents of the capsule will be dissolved it appears as a mixture.
- Aktivt stof: chenodeoxycholsyre.
- The active substance is chenodeoxycholic acid.
Chenodeoxycholic acid Leadiant-kapsler behandler CTX ved at erstatte kroppens egen chenodeoxycholsyre og derved forhindre ophobning af fedtaflejringer.
Chenodeoxycholic acid Leadiant capsules treats CTX by replacing the chenodeoxycholic acid, which prevents the build-up of the fatty deposits.
Følgende lægemidler kan mindske virkningen af Chenodeoxycholic acid Leadiant:
The following medicines may reduce the effect of Chenodeoxycholic acid Leadiant:
Leverbivirkninger ikke kendt
Hepatic adverse reactions not known
En lille del af chenodeoxycholsyren udskilles med fæces.
A small portion of chenodeoxycholic acid is excreted with faeces.
Chenodeoxycholic acid Leadiant 250 mg hårde kapsler chenodeoxycholsyre
Chenodeoxycholic acid Leadiant 250 mg hard capsules chenodeoxycholic acid
Chenodeoxycholsyre sammen med andre lægemidler Samtidig administration af ciclosporin, sirolimus og phenobarbital anbefales ikke, se pkt.
Effects of chenodeoxycholic acid with other medicinal products Co-administration with ciclosporin, sirolimus, phenobarital is not recommended, see section 4.5 for further details.
De væsentligste bivirkninger er anført i nedenstående tabel.
This includes any possible side effects not listed in this leaflet.
Til spædbørn og børn, som ikke kan synke kapsler, kan kapslerne åbnes forsigtigt og indholdet opblandes i en 8,4 % opløsning af natriumhydrogencarbonat, se pkt.
For infants and children who cannot swallow capsules, the capsules may be carefully opened and the content added to sodium bicarbonate solution 8.4%, see section 6.6.
Det skal du vide, før du begynder at tage Chenodeoxycholic acid Leadiant Tag ikke Chenodeoxycholic acid Leadiant
What you need to know before you take Chenodeoxycholic acid Leadiant Do not take Chenodeoxycholic acid Leadiant
Følgende lægemidler kan påvirke niveauet af Chenodeoxycholic acid Leadiant:
The following medicines may affect the levels of Chenodeoxycholic acid Leadiant:
Pakningsstørrelser og yderligere oplysninger - Chenodeoxycholic acid Leadiant indeholder:
Contents of the pack and other information - What Chenodeoxycholic acid Leadiant contains
Chenodeoxycholsyre givet oralt absorberes i tyndtarmen.
Chenodeoxycholic acid given orally is absorbed in the small intestine.
Der er ikke udført interaktionsstudier med chenodeoxycholsyre og andre samtidigt administrerede lægemidler hos patienter med CTX.
In patients with CTX, no interaction studies with chenodeoxycholic acid and concomitantly administered medicinal products have been performed.
Hvis administration af ciclosporin eller sirolimus anses for nødvendig, bør de biliære alkoholer i serum og urin monitoreres tæt og dosis af chenodeoxycholsyre justeres i henhold hertil.
If administration of ciclosporin or sirolimus is considered necessary, serum and urine bile alcohol levels should be closely monitored and the chenodeoxycholic acid dose adjusted accordingly.
Samlet daglig dosis = 3 kg x 5 mg/kg = 15 mg
The total daily dose = 3 kg x 5 mg/kg = 15 mg
Chenodeoxycholic acid Leadiant-kapsler indeholder stoffet chenodeoxycholsyre.
Chenodeoxycholic acid Leadiant capsules contain a substance called chenodeoxycholic acid.
Hvis det er nødvendigt at tage colestyramin, skal chenodeoxycholsyre tages enten 1 time før colestyramin eller 4-6 timer efter.
If it is necessary to take colestyramine then chenodeoxycholic acid should be taken either one hour before colestyramine or 4-6 hours after.
Startdosis er 5 mg pr. kg pr. dag.
The starting dose will be calculated at 5 mg per kg per day.
Hvis administration af phenobarbital anses for nødvendig, bør de biliære alkoholer i serum og urin monitoreres tæt og dosis af chenodeoxycholsyre justeres i henhold hertil.
If administration of phenobarbital is considered necessary, serum and urine bile alcohol levels should be closely monitored and the chenodeoxycholic acid dose adjusted accordingly.
Den opdelte dosis, når den gives 3 gange om dagen = 15 mg/3 = 5 mg
The divided dose when given three times a day = 15 mg = 5 mg
Brug of orale antikonceptiva anbefales ikke hos patienter, som tager chenodeoxycholsyre, se pkt.
The use of oral contraceptives is not recommended in patients taking chenodeoxycholic acid, see section 4.5 for further details.
Til spædbørn, børn og andre, som ikke kan synke kapsler og/eller skal tage en dosis på under 250 mg, kan en kapsel åbnes og indholdet blandes med en 8,4 % opløsning af natriumhydrogencarbonat.
For babies, children and those who cannot swallow capsules and/or need to take a dose below 250 mg, a capsule may be opened and the contents mixed with 8.4% sodium bicarbonate solution.
Hvis du oplever bivirkninger, bør du tale med din læge eller apoteket.herunder bivirkninger, som ikke er nævnt her.
If you get any side effects, talk to your doctor or, pharmacist.
Hvis det er nødvendigt at tage colestyramin, skal du tage Chenodeoxycholic Leadiant enten 1 time før colestyramin eller 4-6 timer efter.
If you have to take colestyramine then take Chenodeoxycholic acid Leadiant either one hour before colestyramine or 4-6 hours after.
Det skal du vide, før du begynder at tage Chenodeoxycholic acid Leadiant 3.
What you need to know before you take Chenodeoxycholic acid Leadiant 3.
Chenodeoxycholsyre bør tages enten 1 time før colestyramin eller 4-6 timer efter, se pkt.
Chenodeoxycholic acid should be taken either one hour before cholestyramine or 4-6 hours after.
Den opdelte dosis, når den gives 3 gange om dagen = 150 mg/3 = 50 mg
The divided dose when given three times a day = 150 mg = 50 mg
Særlige populationer Ældre patienter (≤ 65 år) Dosisjustering er ikke nødvendig.
Elderly patients (≥ 65 years)
Patient på 10 kg, der skal have en dosis på 15 mg/kg chenodeoxycholsyre.
10 kg patient on a dose of 15 mg/kg of chenodeoxycholic acid.
Der forekom et tilfælde af leverbivirkninger hos et 2 uger gammelt spædbarn med diagnosen CTX, og dette tilfælde er beskrevet i nedenstående afsnit.
One instance of mild intermittent constipation occurred in an adult and another instance occurred in a child. One instance of hepatic adverse reactions occurred in a two week old infant diagnosed with CTX and is discussed in the section below.
Chenodeoxycholsyre er indiceret til behandling af spædbørn, børn og unge i alderen fra 1 måned til 18 år samt voksne med medfødte fejl i den primære galdesyresyntese som følge af sterol-27-hydroxylasemangel (fremtræder som cerebrotendinøs xantomatose (CTX)).
Chenodeoxycholic acid is indicated for the treatment of inborn errors of primary bile acid synthesis due to sterol 27 hydroxylase deficiency (presenting as cerebrotendinous xanthomatosis (CTX)) in infants, children and adolescents aged 1 month to 18 years and adults.
Patient på 3 kg, der skal have en dosis på 5 mg/kg chenodeoxycholsyre.
3 kg patient on a dose of 5 mg/kg of chenodeoxycholic acid.
Når lægemidlet er godkendt, er indberetning af formodede bivirkninger vigtig.Det muliggør løbende overvågning af benefit/risk-forholdet for lægemidlet.Læger og sundhedspersonale anmodes om at indberette alle formodede bivirkninger via det nationale rapporteringssystem anført i Appendiks V.
Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Til børn, unge og voksne, som ikke kan synke kapsler og/eller har behov for en dosis under 250 mg, kan kapslerne åbnes og indholdet tilsættes en 25 ml 8,4 %-opløsning af natriumhydrogenkarbonat (1 mmol/ml) for at frembringe en suspension med chenodeoxycholsyre 10 mg/ml.
For children, adolescents and adults who cannot swallow capsules and/or need to take a dose below 250 mg, the capsules may be opened and the contents added to 25 mL of sodium bicarbonate solution 8.4% (1 mmol/mL) to produce a suspension containing chenodeoxycholic acid 10 mg/mL.
Kvinder i den fertile alder bør anvende en effektiv præventionsmetode, se pkt.
Women of childbearing potential should use an effective method of contraception, see section 4.6 for further details.
Til spædbørn kan kapslerne åbnes, indholdet tilsættes en 50 ml 8,4 %-opløsning af natriumhydrogenkarbonat (1 mmol/ml) og blandes for at frembringe en suspension, der indeholder chenodeoxycholsyre 5 mg/ml.
For infants the capsules may be opened, the contents added to 50 mL of sodium bicarbonate solution 8.4% (1 mmol/mL) and mixed to produce a suspension containing chenodeoxycholic acid 5 mg/mL.
Til spædbørn kan kapslerne åbnes og indholdet tilsættes en 50 ml 8,4 %-opløsning af natriumhydrogenkarbonat (1 mmol/ml) for at frembringe en suspension med chenodeoxycholsyre 5 mg/ml.
For infants the capsules may be opened and the contents added to 50 mL of sodium bicarbonate solution 8.4% (1 mmol/mL) to produce a suspension containing chenodeoxycholic acid 5 mg/mL.
Behandling med Chenodeoxycholic acid Leadiant skal kontrolleres af en læge.
Chenodeoxycholic acid Leadiant should be used under medical supervision.
Hvis du har glemt at tage Chenodeoxycholic acid Leadiant
If you forget to take Chenodeoxycholic acid Leadiant
Sådan skal du tage Chenodeoxycholic acid Leadiant 4.
How to take Chenodeoxycholic acid Leadiant 4.
Hvis du holder op med at tage Chenodeoxycholic acid Leadiant
If you stop taking Chenodeoxycholic acid Leadiant
Hver hårde kapsel indeholder 250 mg chenodeoxycholsyre.
Each hard capsule contains 250 mg of chenodeoxycholic acid.
Patienter med CTX har behov for behandling resten af livet.
Chenodeoxycholic acid Leadiant capsules can be used from the age of one month and patients with CTX will require treatment for the rest of their life.
- Hver kapsel indeholder 250 mg chenodeoxycholsyre.
- Each capsule contains 250 mg of chenodeoxycholic acid.
P-piller anbefales ikke.
Oral contraceptives are not recommended.
Brug af anden medicin sammen med Chenodeoxycholic acid Leadiant
Other medicines and Chenodeoxycholic acid Leadiant
Samtidig administration af orale antikonceptiva anbefales ikke, se pkt.
Co-administration with oral contraceptives is not recommended, see section 4.5 for further details.
Det anbefales, at du ikke tager p-piller, mens du tager Chenodeoxycholic acid Leadiant.
It is not recommended to take oral contraceptives whilst taking Chenodeoxycholic acid Leadiant.
En kapsel indeholder 250 mg chenodeoxycholsyre.
Each capsule contains 250 mg chenodeoxycholic acid.
(Daglig dosis i mg/doseringshyppighed) = Opdelt dosis i mg
(Daily dose in mg) = Divided dose in mg (Dose frequency) Volume to administer: (Divided dose in mg x 1 ml) = Amount of suspension to give
Protokol - senest over patienter med medfødte fejl i den primære galdesyresyntese som følge af sterol 27-hydroxylasemangel (spædbørn, børn og unge i alderen 1 måned til 18 år samt voksne).
In order to collect long term safety and efficacy data in patients treated with Protocol - by chenodeoxycholic acid, the MAH will submit the results of a study deriving from a registry of patients with inborn errors of primary bile acid synthesis due to sterol 27 hydroxylase deficiency in infants, children and adolescents aged 1 month to 18 years and adults.
(Opdelt dosis i mg ∙ 1 ml)/10 mg = Volumen suspension, der skal gives
(Daily dose in mg) = Divided dose in mg (Dose frequency) Volume to administer: (Divided dose in mg) x 1 ml = Amount of suspension to give
Sådan skal du tage Chenodeoxycholic acid Leadiant
How to take Chenodeoxycholic acid Leadiant
Mave-tarm-kanalen
Capsule content Maize starch
Dette blev bekræftet inden for rammerne af denne artikel 30-procedure.
This was confirmed within the framework of this article 30 procedure.
Stabilitetsdata ved disse forsøgsbetingelser har vist, at resultaterne overholder godkendelseskriterierne, og at produktet er stabilt.
The stability data at these testing conditions has shown that the results are within the acceptance criteria and the product is stable.
Samlet resumé af den videnskabelige vurdering af Sandimmun og relaterede navne (se bilag I)
Overall summary of the scientific evaluation of Sandimmun and associated names (see Annex I)
Desuden har nylige undersøgelser bekræftet fordelene ved Sandimmun til forskellige former af nefrotisk syndrom hos børn og voksne.
Moreover, recent trials have confirmed the benefit of Sandimmun in different forms of nephrotic syndrome in children and adults.
Indehaveren af markedsføringstilladelsen bekræftede, at der er udført stabilitetsundersøgelser ved langvarig opbevaring ved 25 °C/60 % RH og ved accelererede betingelser ved 40 °C/75 % RH.
The MAH confirmed that the stability studies have been performed at the long term conditions at 25°C/60%RH and accelerated conditions also at 40°C/75% RH.
Angivelsen “Den daglige dosis af Sandimmun bør altid fordeles på to separate doser” blev delvis godkendt af CHMP, da ordet “altid” bør udelades (i nogle tilfælde kan administration tre gange dagligt være nødvendig).
However the statement “The daily doses of Sandimmum should always be given in two divided doses” was partly endorsed by the CHMP since the word “always” should be omitted (in some cases, three times daily administration may be needed).
Indehaveren af markedsføringstilladelsen fastslog, at opbevaringsbetingelserne i produktresuméerne for Sandimmun, bløde gelatinekapsler og orale opløsninger, i forvejen er rettet ind efter kravene i “Guideline on Declaration of Storage Conditions” (CPMP/QWP/609/96/Rev 2, dateret den 19. november 2007).
The MAH confirmed that the storage conditions in the SmPCs of Sandimmun soft gelatin capsules and oral solutions are already aligned with the requirements set in the Guideline on Declaration of Storage Conditions (CPMP/QWP/609/96/Rev 2 dated 19 Nov 2007).
Sandimmun er en oliebaseret formulering af ciclosporin.
Sandimmun is an oil-based formulation of ciclosporin.
Registreringen af Sandimmun Neoral byggede på data vedrørende virkning og sikkerhed fra kliniske undersøgelser med den oliebaserede formulering (Sandimmun), der første gang blevet registreret i Schweiz i december 1982.
The registration of Sandimmun Neoral was based on efficacy and safety data from clinical studies performed with the oil-based formulation (Sandimmun), first registered in Switzerland in December 1982.
Indehaveren af markedsføringstilladelsen foreslog følgende ordlyd til denne indikation: “Sandimmun er indiceret til patienter med svær atopisk dermatitis, når systemisk behandling er påkrævet.” Indikationen atopisk dermatitis er godkendt i 15 EU-lande med den ordlyd, der er foreslået af indehaveren af markedsføringstilladelsen.
The MAH proposed the following wording for this indication: “Sandimmun is indicated in patients with severe atopic dermatitis when systemic therapy is required.” The MAH's proposed indication wording for the Atopic dermatis is approved in 15 EU countries.
Dossieret for Sandimmun dannede grundlag for gennemgangen, da dossieret til ansøgningen for den nye formulering af ciclosporin (Sandimmun Neoral) byggede på en farmakokinetisk vurdering, som viste ækvivalens mellem de to former af ciclosporin (oliebaseret formulering versus mikroemulgeret formulering).
The dossier of Sandimmun was used as a basis of the review as the dossier supporting the approval of the new ciclosporin formulation (Sandimmun Neoral) was based on pharmacokinetics evaluation that demonstrated equivalence between the 2 forms of ciclosporin (oil-based formulation versus microemulsified formulation).
Indehaveren af markedsføringstilladelsen indvilligede derfor i at revidere ordlyden som følger med anbefaling af ensartet administration af Sandimmun hvad angår klokkeslæt og i forhold til måltiderne: “Dagsdosis af Sandimmun/Sandimmun Neoral gives altid som to separate doser, der fordeles ligeligt over døgnet, og tages på samme klokkeslæt, dvs. aften og morgen.
The MAH therefore agreed to revise the wording, recommending that Sandimmun should be administered on a consistent schedule with regard to time of day and relation to meals, as follows: “The daily doses of Sandimmun/Sandimmun Neoral always should be given in two divided doses equally distributed throughout the day, taken at the same time of the day, e.g., in the morning and in the evening.
Indehaveren af markedsføringstilladelsen bibeholdt derfor erklæringen i produktresuméet og indlægssedlen med ordlyden “Der er ingen særlige krav til opbevaringstemperatur for dette lægemiddel” i overensstemmelse med retningslinjerne.
Therefore, The MAH adhered to the statement on SPC and PL as “This medicinal product does not require any special temperature storage conditions” in accordance with the guideline.
CHMP bemærkede, at markedsføringstilladelserne for Sandimmun og relaterede navne, koncentrat til infusionsvæske, opløsning, 50 mg/ml, alene dækker ovennævnte transplantationsindikationer (dvs. organtransplantation og knoglemarvstransplantation).
The CHMP noted that Marketing Authorisations for Sandimmum and associated names 50mg/ml concentrate for solution for infusion are solely granted for the above-mentioned transplantation indications (namely, the solid organ transplantation and the bone marrow transplantation).
CHMP er af den opfattelse, at anvendelse af Sandimmun til behandling af afstødning er mere hensigtsmæssig til cellulær end til humoral afstødning, baseret på virkningsmekanismen af calcineurinhæmmere.
The CHMP is of the view that introducing Sandimmun for the treatment of rejection is most appropriate for cellular rather than humoral rejection, based on the mechanism of action of CNI's.
Endelig blev indehaveren af markedsføringstilladelsen anmodet om at ajourføre dette afsnit med flere oplysninger om ciclosporins potentiale for at hæmme andre transportproteiner end P-gp.
Finally the MAH was also requested to update this section with more information concerning the inhibitory potential of ciclosporin on other transporters than P-gp.
Den daglige dosis af Sandimmun bør altid fordeles på to separate doser.” Markedsføringstilladelsesindehaverens erklæring “De angivne dosisintervaller for oral administration er kun vejledende” kan godkendes af CHMP.
The daily doses of Sandimmum should always be given in two divided doses.” The MAH's statement “The dose ranges given for oral administration are intended to serve as guidelines only” is endorsed by the CHMP.
• Sandimmun og relaterede navne, koncentrat til infusionsvæske, opløsning, 50 mg/ml
• Sandimmum and associated names 50mg/ml concentrate for solution for infusion
På ovenstående grundlag finder CHMP, at benefit/risk-forholdet for Sandimmun og relaterede navne er positivt, og at de harmoniserede produktinformationer kan godkendes.
Based on the above the CHMP considers the benefit/risk ratio of Sandimmun to be favourable and the harmonised PI to be approvable.
Indehaveren af markedsføringstilladelsen foreslog desuden en ændring i ordlyden af “Særlige opbevaringsbetingelser” i produktresuméet for Sandimmun, koncentrat til infusionsvæske, opløsning, 50 mg/ml, hvilket ligeledes er i overensstemmelse med de nævnte retningslinjer.
In addition, the MAH proposed a correction in the wording of the “Special precautions for storage” in the SmPC for Sandimmun 50 mg/ml concentrate for solution for infusion, also in conformance to the above-mentioned Guideline.
• det produktresumé og den etikettering og indlægsseddel, der er foreslået af indehaveren (indehaverne) af markedsføringstilladelserne, blev vurderet på grundlag af den forelagte dokumentation og de videnskabelige drøftelser i udvalget,
• the summary of products characteristic, labelling and package leaflet proposed by the marketing authorisation holder(s) have been assessed based on the documentation submitted and the scientific discussion within the Committee the CHMP has recommended the amendment of the marketing authorisations for which the summary of product characteristics, labelling and package leaflet are set out in Annex III for Sandimmum and associated names (see Annex I).
Efter vurderingen af forslaget fra markedsføringstilladelsesindehaveren, besvarelserne til LoQ og LoOI og drøftelserne i udvalget vedtog CHMP til sidst et harmoniseret sæt dokumenter til produktinformation for de forskellige pakningsstørrelser af Sandimmun og relaterede navne.
In conclusion, based on the assessment of the MAH's proposal, the responses to the LoQ, LoOI and following the discussions of the committee, the CHMP agreed upon and adopted harmonised sets of PI documents for the various presentations of Sandimmun and associated names.
Indehaveren af markedsføringstilladelsen foreslog en ny ordlyd, som blev godkendt af CHMP.
A new wording was proposed by the MAH and agreed by the CHMP.