FrancophonIA/ELRC3.0 huggingface dataset:
English: Considering that gingival enlargement is a known adverse reaction to treatment with felodipine and it is preventable by good oral hygiene, the CHMP endorsed the MAH proposal on including the warning “mild gingival enlargement has been reported in patients with pronounced gingivitis/periodontitis” in the section 4.4 of the harmonised EU SmPC for Plendil.
Danish: I betragtning af, at gingival hævelse er en kendt bivirkning til behandling med felodipin og kan forebygges ved god mundhygiejne, godtog CHMP indehaveren af markedsføringstilladelsens forslag om at advarslen “der er beskrevet let gingival hævelse hos patienter med udtalt gingivitis/periodontitis” indsættes i punkt 4.4 af det harmoniserede EU-produktresumé for Plendil,
English: Section 4.5 - Interaction with other medicinal products and other forms of interaction For the section 4.5, the MAH proposed to use the text from the CSP, with one addition and one deletion as per CDS.
Danish: Punkt 4.5 - Interaktion med andre lægemidler og andre former for interaktion Til punkt 4.5 foreslog indehaveren af markedsføringstilladelsen at benytte teksten fra den centrale sikkerhedsprofil, med én tilføjelse og én sletning i overensstemmelse med det centrale datablad.
English: Data on the efficacy and safety of specifically felodipine in this indication are very scarce and the MAH did not discuss the extrapolability of the results obtained with other dihydropyridines in this indication.
Danish: Der foreligger kun meget sparsomme specifikke data om virkningen og sikkerheden af felodipin ved denne indikation, og indehaveren af markedsføringstilladelsen kom ikke nærmere ind på, om de opnåede resultater ved denne indikation kan ekstrapoleres til andre dihydropyridiner.
English: The wording on section 4.8 was divergent.
Danish: Der var afvigelser i ordlyden af punkt 4.8.
English: The MAH agreed and included that ‘Plendil contains castor oil, which can cause stomach upset and diarrhoea'.
Danish: Indehaverne af markedsføringstilladelsen tilsluttede sig dette og indsatte tilføjelsen “Plendil indeholder ricinusolie, som kan medføre mavebesvær og diarré”
English: The information on castor oil is given under section 2 and section 6 of the proposed harmonised SmPC text and the MAH is of the opinion that castor oil is an excipient in Plendil tablets in an amount too small to have any effects, except for possibly hypersensitivity and hypersensitivity to any component of the product is a contraindication.
Danish: Oplysningerne om ricinusolie gives i punkt 2 og punkt 6 i det foreslåede harmoniserede produktresumé, og indehaveren af markedsføringstilladelsen finder, at mængden af ricinusolie som hjælpestof i Plendil tabletter er for lille til at have nogen virkning bortset fra hypersensitivitet; hypersensitivitet over for et eller flere af indholdsstofferne i lægemidlet er en kontraindikation.
English: Overall, the statement of grounds for not including adverse events included in one or few national texts is considered acceptable by the CHMP.
Danish: Overordnet kunne CHMP godkende de anførte begrundelser for ikke at medtage bivirkninger, som indgår i en eller enkelte af de nationale tekster.
English: Furthermore, during the initial weeks of pregnancy the embryo is nourished by the yolk sack, and, consequently, not exposed to felodipine taken by the mother to be. Subjective recognition of pregnancy usually occurs at the end of this period.
Danish: I de første uger af graviditeten får fostret desuden i sin næring fra blommesækken og bliver derfor ikke eksponeret for felodipin indtaget af moderen.
English: • the scope of the referral was the harmonisation of the Summary of Products Characteristics, labelling and package leaflet,
Danish: • Indbringelsen vedrørte harmoniseringen af produktresuméet, etiketteringen og indlægssedlen.
English: In nonclinical reproductive toxicity studies there were foetal developmental effects, which are considered to be due to the pharmacological action of felodipine'.
Danish: I de prækliniske reproduktionstoksicitetsundersøgelser var der påvirkning af fosterudviklingen, som må antages at skyldes den farmakologiske virkning af felodipin.”
English: The CHMP asked the MAH to further discuss the totality of available data on felodipine and dihydropyridine calcium channel blockers to support the indication of vasospastic angina, since currently calcium channel blockers are in prominent position for this indication.
Danish: CHMP anmodede indehaveren af markedsføringstilladelsen om nærmere at gennemgå samtlige foreliggende data om felodipin og calciumantagonister af dihydropyridintypen til støtte for indikationen vasospastisk angina, da calciumantagonister på nuværende tidspunkt indtager en fremtrædende plads i forbindelse med denne indikation.
English: Finally the CHMP requested the MAH to add a warning on castor oil.
Danish: Endelig anmodede CHMP indehaveren af markedsføringstilladelsen om at tilføje en advarsel om ricinusolie.
English: The CHMP asked the MAH to further substantiate this sentence, or in case of data are not available, add that breastfeeding during treatment with felodipine is not recommended given the lack of data.
Danish: CHMP anmodede indehaveren af markedsføringstilladelsen om at underbygge denne sætning nærmere eller, hvis der ikke foreligger data, tilføje, at amning under behandling med felodipin frarådes på grund af manglende data.
English: Section 4.3 - Contraindications Divergences were found in section 4.3 of the SmPC.
Danish: Afsnit 4.3 - Kontraindikationer Der blev fundet afvigelser i punkt 4.3 af produktresuméet.
English: Caution is recommended especially at the start of treatment.” The MAH agreed with the above proposed wording.
Danish: Forsigtighed anbefales, navnlig ved begyndelsen af behandlingen.”
English: Section 4.4 - Special warnings and precautions for use Divergences were found in section 4.4 of the SmPC.
Danish: Afsnit 4.4 - Særlige advarsler og forsigtighedsregler vedrørende brugen Der blev fundet afvigelser i punkt 4.4 af produktresuméet.
English: The MAH proposed not to include the indication vasospastic angina in the harmonised SmPC.
Danish: Indehaveren af markedsføringstilladelsen foreslog at udelade indikationerne vasospastisk angina i det harmoniserede produktresumé.
English: The MAH considers that the fetodevelopmental findings in the rabbit, and the consequences of the prolonged parturition in the rat, are due to the pharmacological action of felodipine.
Danish: Indehaveren af markedsføringstilladelsen finder, at resultaterne vedrørende fosterudvikling hos kaniner og følgerne af langstrakt fødsel hos rotten kan tilskrives den farmakologiske virkning af felodipin.
English: The CHMP endorsed the MAH opinion on adopting the CDS text with some modifications, since it covers the pharmacokinetic properties of felodipine.
Danish: CHMP godtog indehaveren af markedsføringstilladelsens hensigt om at anvende teksten fra det centrale datablad med visse ændringer, da det dækker de farmakokinetiske egenskaber af felodipin.
English: The wording on section 5.2 was divergent across MSs.
Danish: Ordlyden af punkt 5.2 afveg mellem medlemsstaterne.
English: The CHMP endorsed the MAH position not to include “Pregnancy must be excluded before starting treatment with felodipine/suitable contraceptive measure should be taken to prevent pregnancy” in section 4.6 of the harmonised EU SmPC for Plendil.
Danish: CHMP godtog indehaveren af markedsføringstilladelsen synspunkt: “Graviditet skal udelukkes fra påbegyndelse af behandlingen med felodipin, eller der skal anvendes sikker prævention” burde udelades i punkt 4.6 af det harmoniserede EU-produktresumé for Plendil.
English: The CHMP endorsed the MAH proposal on a minor re-wording of section 4.9 of the CSP and to implement it as the harmonised text across EU MS.
Danish: CHMP godtog indehaveren af markedsføringstilladelsens forslag om en mindre omformulering af punkt 4.9 i den centrale sikkerhedsprofil, der indsættes som harmoniseret tekst i alle EU's medlemsstater.
English: The CHMP asked the MAH to insert statements regarding interactions leading increased plasma concentration of felodipine and interactions leading to decreased plasma concentration of felodipine.
Danish: CHMP anmodede indehaveren af markedsføringstilladelsen om at indsætte erklæringerne om interaktioner, der henholdsvis øger og nedsætter plasmakoncentration af felodipin.
English: The MAH proposed the use of section 5.3 of the CDS for the preclinical section of the harmonised EU SmPC for felodipine, since the text is based on current non clinical nomenclature.
Danish: Indehaveren af markedsføringstilladelsen påtænkte at anvende punkt 5.3 i det centrale datablad til den prækliniske del af det harmoniserede EU-produktresumé for felodipin, da teksten er baseret på den nugældende prækliniske nomenklatur.
English: The CHMP accepted the proposal from the MAH to adopt the contraindications: pregnancy; Hypersensitivity to felodipine or ‘any of the excipients listed in section 6.1'; decompensated heart failure, instead of uncompensated heart failure as previously; acute myocardial infarction; unstable angina pectoris; haemodynamically significant cardiac valvular obstruction and dynamic cardiac outflow obstruction as the harmonised text.
Danish: CHMP godtog indehaveren af markedsføringstilladelsens forslag om, at den harmoniserede tekst til kontraindikationerne skulle være følgende: Graviditet, overfølsomhed over for felodipin eller over for et eller flere af hjælpestofferne anført i punkt 6.1, dekompenseret hjerteinsufficiens (i stedet for som hidtil ukompenseret hjerteinsufficiens), akut myokardieinfarkt, ustabil angina pectoris, hæmodynamisk betydningsfuld hjerteklapobstruktion og dynamisk kardial udløbsobstruktion.
English: Consequently, the CHMP agrees with the MAH that, although vasospastic angina indication is a condition where the current European Society of Cardiology clinical guidelines recommend calcium channel blockers like felodipine as the first-line treatment, an indication for vasospastic angina pectoris cannot be justified.
Danish: CHMP er derfor enig med indehaveren af markedsføringstilladelsen i, at indikationen spastisk angina pectoris ikke kan begrundes, skønt calciumantagonister såsom felodipin anbefales som førstevalgsbehandling af vasospastisk angina i de gældende kliniske retningslinjer fra European Society of Cardiology.
English: The MAH reworded the text accordingly with CHMP requests “Felodipine has been detected in breast milk, and due to insufficient data on potential effect on the infant, treatment is not recommended during breastfeeding”.
Danish: Indehaveren af markedsføringstilladelsen omformulerede teksten efter CHMP's anmodninger: “Felodipin er genfundet i modermælk, og behandling frarådes under amning, da der ikke foreligger tilstrækkelige data om den potentielle virkning på barnet”.
English: Besides a warning that ‘The efficacy and safety of felodipine in the treatment of hypertensive emergencies has not been studied' was also be included in view of the missing evidence with felodipine in hypertensive emergencies and to be in agreement with the product information of amlodipine the Rapporteurs see the need to include the warning as proposed in the LoOI.
Danish: På baggrund af den manglende dokumentation for anvendelse af felodipin ved akut hypertension og med henblik på at rette produktoplysningerne ind med amlodipin var det nødvendigt at indsætte advarslen “Sikkerheden om virkningen af felodipin til behandling af akut hypertension er ikke undersøgt”, og rapportørerne finder det desuden nødvendigt at indsætte advarslen som foreslået i listen over udestående punkter.
English: The MAH justified the deletion of ADRs using the Empirical Bayesian Data Mining techniques to compute disproportionality scores from the MAH's global safety database.
Danish: Sletningen af bivirkninger blev af indehaveren af markedsføringstilladelsen begrundet med beregninger af scoreværdier for uforholdsmæssighed fra indehaveren af markedsføringstilladelsens globale sikkerhedsdatabase, der var foretaget med Empirical Bayesian Data Mining.
English: The wording was divergent for this section across EU SmPCs.
Danish: Ordlyden af dette punkt divergerede mellem EU's medlemsstater.
English: The CHMP requested the MAH to add information on when a gastric lavage should be performed.
Danish: CHMP anmodede indehaveren af markedsføringstilladelsen om at tilføje anvisninger for, hvornår der skulle foretages maveskylning.
English: The MAH provided the CHMP with the justification of the reason why “Reproductive toxicity studies have demonstrated foetotoxicity effects” should not be in the harmonised EU SmPC for Plendil.
Danish: Indehaveren af markedsføringstilladelsen begrundede over for CHMP, at “Undersøgelser af reproduktionstoksicitet har vist føtotoksiske virkninger” ikke burde indgå i det harmoniserede EUproduktresumé for X>: Resultaterne af reproduktionsundersøgelserne giver ikke evidens for direkte føtotoksicitet.
English: However, outside the referenced trials, no significant publication have been found, limiting the total reported material on felodipine use in vasospastic angina to around 30 patients.
Danish: Materialet om anvendelse af felodipin ved vasospastisk angina omfatter således kun ca. 30 patienter.
English: Regarding the sentence “Pregnancy must be excluded before starting treatment with felodipine/ suitable contraceptive measure should be taken to prevent pregnancy”, the MAH safety surveillance for
Danish: Hvad angår sætningen “Graviditet skal udelukkes før påbegyndelse af behandlingen med felodipin, eller der skal anvendes sikker prævention” har indehaveren af markedsføringstilladelsens sikkerhedsovervågning af Plendil ikke vist overforekomst eller stigning i uønskede virkninger vedrørende fertilitet eller graviditet.
English: The CHMP requested the MAH to shorten the text related to pharmacodynamic properties since it included parts of limited clinical relevance or not considered justified by clinical evidence.
Danish: Afsnit 5.1 - Farmakodynamiske egenskaber CHMP anmodede indehaveren af markedsføringstilladelsen om at forkorte teksten om farmakodynamiske egenskaber, da den omfattede dele, der har begrænset klinisk relevans eller savner begrundelse i klinisk evidens.
English: The MAH agreed to include “In non-clinical reproductive toxicity studies there were a foetal developmental effects, which are considered to be due to the pharmacological action of felodipine.”
Danish: Indehaveren af markedsføringstilladelsen tilsluttede sig at indsætte “I de prækliniske undersøgelser af reproduktionstoksicitet var der påvirkning af fosterudviklingen, som antages at skyldes den farmakologiske virkning af felodipin.”
English: The section 4.2 was divergent across MSs.
Danish: I punkt 4.2 afveg mellem medlemsstaterne.
English: In conclusion, based on the assessment of the MAH proposal and responses and following the discussions of the Committee, the CHMP adopted harmonised sets of Product Information documents of Plendil and associated names.
Danish: CHMP vedtog afsluttende et harmoniseret sæt produktinformationsdokumenter for Plendil og relaterede navne på grundlag af indehaveren af markedsføringstilladelsens forslag og besvarelser samt udvalgets drøftelser.
English: Contact a doctor immediately if you get any of these symptoms.
Danish: Kontakt lægen med det samme, hvis du får disse symptomer.
English: The wording for these products remains as per the below.
Danish: Ordlyden for disse lægemidler er fortsat som angivet nedenfor.
English: Other side effects (frequency not known)
Danish: Andre bivirkninger (hyppighed ikke kendt)
English: Adopted at the 24-27 October 2016 PRAC
Danish: Vedtaget på PRAC's møde 24.-27. oktober 2016
English: 2 - What you need to know before you <take> {product name}
Danish: 2 - Det skal <De> <du> vide, før <De> <du> begynder at tage {præparatnavn}
English: Restless legs syndrome (frequency uncommon (≥ 1/1,000 to < 1/100))
Danish: Restless legs-syndrom (ikke almindelig (≥ 1/1 000 til < 1/100))
English: No changes have been made to the product information wording for cobicistat containing products as compared to the PRAC recommendation published on the 26th September 2016.
Danish: Der er ikke foretaget ændringer i ordlyden af produktinformationen for cobicistat-holdige lægemidler i forhold til den PRAC-anbefaling, der blev offentliggjort den 26. september 2016.
English: Olanzapine - Restless legs syndrome (EPITT no 18659)
Danish: Olanzapin - Restless legs-syndrom (EPITT-nr. 18659)
English: Plasma concentrations of these medicinal products may be increased when coadministered with <product name>, resulting in reduced serum cortisol concentrations.
Danish: Plasmakoncentrationen af disse lægemidler kan øges ved samtidig administration af {præparatnavn}, hvilket medfører nedsat serumkortisol.
English: In case of AGEP diagnosis, flucloxacillin should be discontinued and any subsequent administration of flucloxacillin contra-indicated.
Danish: Hvis AGEP diagnosticeres, skal flucloxacillin seponeres, og senere behandling med flucloxacillin er kontraindiceret.
English: Flucloxacillin - Acute generalized exanthematous pustulosis (AGEP)(EPITT no 18773)
Danish: Flucloxacillin - Akut generaliseret eksantematøs pustulose (AGEP)(EPITT-nr. 18773)
English: Uncommon side effects (may affect up to 1 in 100 people) include hypersensitivity (e.g. swelling in the mouth and throat, itching, rash); diabetes or the worsening of diabetes, occasionally associated with ketoacidosis (ketones in the blood and urine) or coma; seizures, usually associated with a history of seizures (epilepsy); muscle stiffness or spasms (including eye movements); restless legs syndrome; problems with speech; slow heart rate; sensitivity to sunlight; bleeding from nose; abdominal distension; memory loss or forgetfulness; urinary incontinence; lack of ability to urinate; hair loss; absence or decrease in menstrual periods; and changes in breasts in males and females such as an abnormal production of breast milk or abnormal growth.
Danish: Ikke almindelige bivirkninger (forekommer hos op til 1 ud af 100 patienter) omfatter overfølsomhed (f.eks. hævelser i mund og hals, kløe, hududslæt); sukkersyge eller forværring af sukkersyge, af og til ledsaget af syreforgiftning (ketoacidose - ketonstoffer i blod og urin) eller bevidstløshed; krampeanfald, sædvanligvis hos patienter med nuværende eller tidligere krampeanfald (epilepsi); muskelstivhed, muskelkramper eller muskelsitren (herunder ufrivillige øjenbevægelser); restless legssyndrom (stærk uro i underbenene); problemer med at tale; langsom hjertefrekvens (puls); øget følsomhed for sollys; næseblod; udspilet mave; hukommelsestab eller glemsomhed; ufrivillig vandladning (urininkontinens); vandladningsbesvær; hårtab; manglende menstruation eller længere intervaller mellem menstruationerne; brystforandringer hos mænd og kvinder, såsom unormal produktion af mælk eller unormal vækst.
English: Undesirable effects (Table)
Danish: Bivirkninger (tabel)
English: Package leaflet 4 - Possible side effects
Danish: Indlægsseddel 4 - Bivirkninger
English: Cobicistat containing products: cobicistat; cobicistat, atazanavir sulfate; cobicistat, darunavir; cobicistat, elvitegravir, emtricitabine, tenofovir alafenamide; cobicistat, elvitegravir, emtricitabine, tenofovir disoproxil fumarateDrug interaction with corticosteroids leading to adrenal suppression (EPITT no 18647)
Danish: Cobicistat-holdige lægemidler: cobicistat; cobicistat, atazanavirsulfat; cobicistat, darunavir; cobicistat, elvitegravir, emtricitabin, tenofoviralafenamid; cobicistat, elvitegravir, emtricitabin, tenofovirdisoproxilfumaratlægemiddelinteraktion ved samtidig brug af kortikosteroider, der medfører binyrebarksuppression (EPITT-nr. 18647)
English: SmPC of all corticosteroids other than beclomethasone (excluding cutaneous formulations) - Double strikethrough represents deletion as compared to the PRAC recommendation published on the 26th September 2016.
Danish: Produktresumé for alle andre kortikosteroider end beclomethason (gælder ikke formuleringer til kutan anvendelse) - Dobbelt overstregning viser slettet tekst i forhold til den PRAC-anbefaling, der blev offentliggjort den 26. september 2016.
English: Summary of product characteristics (SmPC) of cobicistat containing products N.B: For Evotaz, Section 4.4 warning should be maintained.
Danish: Produktresumé for cobicistat-holdige lægemidler Bemærk: For Evotaz skal advarslen i punkt 4.4 bevares.
English: 4 - Possible side effects
Danish: 4 - Bivirkninger
English: A red, scaly rash with bumps under the skin and blisters (exanthematous pustulosis).
Danish: Rødt, skællende hududslæt med buler under huden og blærer (eksantematøs pustulose).
English: Interaction with other medicinal products and other forms of interaction Corticosteroids primarily metabolised by CYP3A (including betamethasone,
Danish: Interaktion med andre lægemidler og andre former for interaktion Kortikosteroider, der primært metaboliseres via CYP3A (bl.a.
English: Frequency not known: AGEP - acute generalized exanthematous pustulosis (see section 4.4)
Danish: Hyppighed ikke kendt: AGEP - akut generaliseret eksantematøs pustulose (se pkt.
English: Interaction not studied with any of the components of <product name>.
Danish: Interaktion er ikke undersøgt, hvad angår indholdsstofferne i
English: Cobicistat containing products
Danish: Cobicistat-holdige lægemidler
English: It is important to tell your doctor if you are taking: corticosteroids including betamethasone, budesonide, fluticasone, mometasone, prednisone, triamcinolone.
Danish: Kortikosteroider, herunder betamethason, budesonid, fluticason, mometason, prednison og triamcinolon.
English: budesonide, fluticasone, mometasone, prednisone, triamcinolone).
Danish: Samtidig brug af {præparatnavn} og betamethason, budesonid, fluticason, mometason, prednison og triamcinolon).
English: fluticasone propionate or other inhaled or nasal corticosteroids) may increase the risk of development of systemic corticosteroid effects, including Cushing's syndrome and adrenal suppression
Danish: kortikosteroider, der metaboliseres via CYP3A (f.eks. fluticasonpropionat eller andre inhalerede eller nasale kortikosteroider) kan øge risikoen for systemiske kortikosteroid-bivirkninger, herunder Cushings syndrom og binyrebarksuppression
English: Alternative corticosteroids which are less dependent on CYP3A metabolism e.g. beclomethasone for intranasal or inhalational use should be considered, particularly for long term use.
Danish: Kortikosteroider, som er mindre afhængige af CYP3A-metabolisering, f.eks. nasal eller inhaleret beclomethason, bør overvejes, navnlig ved langvarig brug.
English: All corticosteroids other than beclomethasone (excluding cutaneous formulations)
Danish: Alle andre kortikosteroider end beclomethason (gælder ikke formuleringer til kutan anvendelse)
English: PL of all corticosteroids other than beclomethasone (excluding cutaneous formulations)
Danish: Indlægsseddel for alle andre kortikosteroider end beclomethason (gælder ikke formuleringer til kutan anvendelse)
English: Package leaflet (PL) of cobicistat containing products
Danish: Indlægsseddel for cobicistat-holdige lægemidler
English: Beclomethasone is less dependent on CYP3A metabolism than some other corticosteroids, and in general interactions are unlikely; however the possibility of systemic effects with concomitant use of strong CYP3A inhibitors (e.g. ritonavir, cobicistat) cannot be excluded, and therefore caution and appropriate monitoring is advised with the use of such agents.
Danish: Beclomethason er mindre afhængig af CYP3A-metabolisering end visse andre kortikosteroider, og generelt er interaktion ikke sandsynlig.
English: PL of beclomethasone containing products (excluding cutaneous formulations)
Danish: Produktresumé for beclomethason-holdige lægemidler (gælder ikke formuleringer til kutan anvendelse)
English: Beclomethasone containing products (excluding cutaneous formulations)
Danish: Beclomethason-holdige lægemidler (gælder ikke formuleringer til kutan anvendelse)
English: Strength Pharmaceutical form
Danish: (Særnavn) Navn Styrke Lægemiddelform Administration Emballage