natgillin/translations-raw huggingface dataset:
CHMP vedtog, at data fremlagt af indehaveren af markedsføringstilladelsen var tilfredsstillende til disse indikationer.
The CHMP accepted that the data presented by the MAH was satisfactory for these indications.
Efter implementering af ændringer blev der foretaget en læsbarhedstest, som blev fremlagt og bedømt under indbringelsesproceduren.
Following all the changes in the SPC there are several corresponding changes to the Package Leaflet After the corrections were implemented a Readability Testing was performed which was submitted and assessed during the referral procedure.
• Recidiv af orofaryngeal eller øsofageal candidiasis hos patienter med hiv-infektion, som har stor risiko for recidiv.
• Relapse of oropharyngeal or oesophageal candidiasis in patients infected with HIV who are at high risk of experiencing relapse.
Vedrørende kryptokokkose foreligger der begrænset dokumentationen for fluconazols virkning ved behandling af kryptokokkose andre steder (f.eks. lunger og kutan kryptokokkose).
Regarding cryptococcosis the evidence for efficacy of fluconazole in the treatment of cryptococcosis of other sites (e.g. pulmonary and cutaneous cryptococcosis) is limited.
CHMP var af den opfattelse, at fluconazol er indiceret ved profylakse af candidainfektioner hos immunkompromitterede børn.
The CHMP agreed that fluconazole is indicated in the prophylaxis of candidal infections in immunocompromised children.
CHMP vedtog, at fluconazol skal indiceres til behandling af kronisk oral atrofisk candidiasis (protesestomatit), hvis mundhygiejne eller topikal behandling er utilstrækkeligt.
The CHMP agreed that fluconazole should be indicated for the treatment of chronic oral atrophic candidiasis (denture sore mouth) if dental hygiene or topical treatment are insufficient.
Ifølge indikationen til voksne var CHMP af den opfattelse, at der er tilstrækkelig dokumentation for indikationen behandling og forebyggelse af recidiv af kryptokokmengitis hos børn.
As per the adult indication the CHMP agreed that there is sufficient evidence for the indication of treatment as well of prevention of relapse of cryptococcal meningitis in children.
• Dermatomycose, herunder tinea pedis, tinea corporis, tinea cruris, tinea versicolor og candida-infektioner i huden, når systemisk behandling er indiceret.
• Dermatomycosis including tinea pedis, tinea corporis, tinea cruris, tinea versicolor and dermal candida infections when systemic therapy is indicated.
Diflucan er hos voksne indiceret til profylakse af:
Diflucan is indicated in adults for the prophylaxis of:
CHMP er enigt i at adskille behandling fra recidivprofylakse ved orofaryngeal candidiasis og fremlægge doseringen tilsvarende.
The CHMP is in agreement in separating the treatment from the prophylaxis of the relapse on Oropharyngeal Candidiasis and presenting the posology accordingly.
Hos den pædiatriske population anvendes fluconazol til behandling af candidainfektion i slimhinder (orofaryngeal, øsofageal), systemisk candidiasis og kryptokokinfektioner samt forebyggelse af svampeinfektioner hos immunkompromitterede børn i risikogruppen efter cytotoksisk kemoterapi eller strålebehandling.
In the paediatric population fluconazole is used for the treatment of mucosal candidiasis (oropharyngeal, oesophageal), systemic candidiasis and cryptococcal infections and the prevention of fungal infection in at-risk immunocompromised children following cytotoxic chemotherapy or radiotherapy.
• formålet med indbringelsen af sagen var at harmonisere produktresuméet, etiketteringen og indlægssedlen
• the scope of the referral was the harmonisation of the summary of products characteristics, labelling and package leaflet
Fluconazol administreret til børn med 12 mg/kg/dag giver en eksponering, som svarer til en standarddosis på 400 mg dagligt hos voksne.
Fluconazole administered to children at 12 mg/Kg/day provides exposure similar to standard 400 mg daily dosing in adults and higher doses are not recommended in children.
CHMP var også af den opfattelse, at indehaveren af markedsføringstilladelsen havde fremlagt tilstrækkelige data om virkning og sikkerhed af fluconazol ved invasive svampeinfektioner (kryptokokkose, invasiv candidiasis) sammenlignet med andre behandlingsmuligheder, og at fluconazol udviste et positivt risk/benefitforhold.
It was also agreed by the CHMP that the MAH provided sufficient data on the efficacy and safety of fluconazole in invasive fungal infections (cryptococcosis, invasive candidiasis) as compared to other therapeutic options and demonstrated a favourable benefit/risk ratio.
Behandlingen kan indledes, før resultater af kulturer og andre laboratorieundersøgelser kendes.
Therapy may be instituted before the results of the cultures and other laboratory studies are known; however, once these results become available, anti-infective therapy should be adjusted accordingly.
Resultaterne af de udførte test viser en tilfredsstillende konsekvens og ensartethed af vigtige produktkvalitetsegenskaber.
The results of tests carried out indicate satisfactory consistency and uniformity of important product quality characteristics, and these in turn lead to the conclusion that the products should have a satisfactory and uniform performance in the clinic.
Indehaveren af markedsføringstilladelsen fremlagde en anmodning om harmonisering af afsnittet om kvalitet.
The MAH submitted a proposal for harmonisation of the Quality module.
• Kronisk oral atrofisk candidiasis (protesestomatit), hvis mundhygiejne eller topikal behandling er utilstrækkeligt.
• Chronic oral atrophic candidiasis (denture sore mouth) if dental hygiene or topical treatment are insufficient.
Fluconazol findes til oral anvendelse som kapsler med 50 mg, 100 mg, 150 mg og 200 mg, som 5 mg/ml syrup og som 50 mg eller 200 mg/5 ml pulver til oral suspension i en formulering til rekonstitution med vand.
Fluconazole is available for oral use in the 50 mg, 100 mg, 150 mg and 200 mg capsule formulation, in the 5 mg/mL syrup formulation, and in the 50 mg or 200 mg/5 mL powder for oral suspension on reconstitution with water formulation.
• Vaginal candidiasis, akut eller recidiverende, når lokal behandling ikke er egnet.
• Vaginal candidiasis, acute or recurrent; when local therapy is not appropriate.
• Kryptokok-meningitis (se pkt.
• Cryptococcal meningitis (see section 4.4).
• Candida balanitis, når lokal behandling ikke er velegnet.
• Candidal balanitis when local therapy is not appropriate.
Dermatomykose inkluderer Tinea pedis, Tinea corporis, Tinea cruris, Tinea versicolor, Tinea unguinium (onychomykose) og candidainfektioner i huden.
Dermatomycoses include Tinea pedis, Tinea corporis, Tinea cruris, Tinea versicolor, Tinea unguinium (onychomycosis) and dermal Candida infections.
Diflucan anvendes til behandling af candidainfektion i slimhinder (orofaryngeal, øsofageal), invasiv candidiasis, kryptokok-meningitis og profylakse af candidainfektioner hos immunkompromitterede patienter.
Diflucan is used for the treatment of mucosal candidiasis (oropharyngeal, oesophageal), invasive candidiasis, cryptococcal meningitis and the prophylaxis of candidal infections in immunocompromised patients.
CHMP noterede sig forslaget fra indehaveren af markedsføringstilladelsen og vedtog en harmoniseret tekst til dette punkt.
The CHMP noted the MAH proposal and adopted a harmonised text for this section.
), syrup, pulver til oral suspension.
Powder for Suspension
• Akut vaginal candidiasis, når lokal behandling ikke er velegnet.
• Acute vaginal candidiasis when local therapy is not appropriate.
Resultaterne understøtter fluconazol som en relevant behandling af candidainfektion i slimhinder, herunder orofaryngeal, øsofageal candidiasis, candiduria og kronisk mukokutan candidiasis.
The results are supportive of fluconazole as an appropriate treatment for mucosal candidiasis including oropharyngeal, oesophageal candidiasis, candiduria and chronic mucocutaneous candidiasis.
• Candidiasis i slimhinder, herunder orofaryngeal, øsofageal candidiasis, candiduria og kronisk mukokutan candidiasis.
• Mucosal candidiasis including oropharyngeal, oesophageal candidiasis, candiduria and chronic mucocutaneous candidiasis.
Punkt 4.2 - Dosering og indgivelsesmåde
Section 4.2 - Posology and method of administration
For nylig har Infectious Diseases Society of America (IDSA: Pappas et al 2009) publiceret en opdateret vejledning i anvendelse af antimykotika, herunder profylakseindikationen, hvor fluconazol er anbefalet til forebyggelse.CHMP var enigt i de fremlagte data og var af den opfattelse, at fluconazol er effektivt som profylakse af candidainfektioner hos patienter med langvarig neutropeni.
Recently, the Infectious Diseases Society of America (IDSA: Pappas et al 2009) published updated guidance for use of antifungal agents including the prevention indication where fluconazole is recommended for prevention.
anvendelse i en formulering med 2 mg/ml saltvandsopløsning.
Fluconazole is available also for intravenous (IV) use in the 2 mg/mL saline solution formulation.
En kapsel med 150 mg er specifikt indiceret til ovennævnte indikationer ved genital candidiasis hos voksne, når lokal behandling ikke er velegnet.
However as the first line treatment of this candidiasis is the topical application, the one 150 mg capsule presentation is specifically indicated for the above genital candidiasis indications in adults when local therapy is not appropriate.
Men lægemiddelrelaterede uønskede hændelser var hyppigere med amphotericin B. CHMP konkluderede, at fluconazol er et sikkert og effektivt lægemiddel ved profylakse eller behandling af invasiv candidiasis sammenlignet med andre behandlinger.
Fluconazole and amphotericin B were associated with similar clinical response rates and survival in the treatment of candidemia; however, drug-related adverse events were more frequent with amphotericin B. The CHMP concluded that fluconazole is a safe and effective medicinal product in prophylaxis or treatment for invasive candidiasis compared to other therapies.
anbefalede CHMP ændringen af de markedsføringstilladelser, for hvilke produktresuméet, etiketteringen og indlægssedlen fremgår af bilag III for Diflucan og relaterede navne (se bilag I).
• the summary of products characteristic, labelling and package leaflet proposed by the marketing authorisation holders 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 Diflucan and associated names (see Annex I).
Indlægsseddel
Oral use
Det understøttes af data fra kliniske undersøgelser og anbefales i kliniske retningslinjer.
Fluconazole therapy is efficacious for several deep mycoses and this is supported by clinical trial data and recommended by clinical guidelines.
mg/kg/dag var mere effektivt end det aktive stof, der blev anvendt til sammenligning, ved forebyggelse af svampeinfektioner.
Fluconazole, administered at doses of 1 mg/Kg/day and 3 mg/Kg/day was more effective than the active comparator at preventing fungal infections.
For formuleringen en 150 mg kapsel har CHMP vedtaget ordlyden i pkt.
For the one 150 mg capsule presentation the section 4.1 of the SPC is agreed by the CHMP as follows:
Anvendelse til børn
Intravenous use
CHMP bemærkede, at doseringen for unge var udeladt.
The CHMP noted that adolescent posology had been omitted; none of the national SPCs described the posology for this age group.
BILAG II
Package Leaflet
Orale eller i.v.
Member State EU/EEA
Her er ingen grund til bekymring.
Do not worry.
Sikkerhedsforanstaltninger vil blive implementeret indtil 09/02/2019
Safety features will be implemented until 9/2/2019.
Én gang dagligt.
Once daily.
Dato for første markedsføringstilladelse: 12 september 2008 Dato for seneste fornyelse: 9 april 2013
Date of first authorisation: 12 September 2008 Date of latest renewal: 9 April 2013
Den absolutte biotilgængelighed er større end 90%.
The absolute bioavailability is greater than 90%.
Hyppighedskategorien er formentlig ikke større end "ikke almindelig".
The frequency category is probably not greater than "uncommon".
De tre ark er markeret med ”Uge 1”, ”Uge 2” og ”Uge 3”.
The three strips are marked with "Week 1", "Week 2" and "Week 3".
- Ændret eller øget seksuel interesse og adfærd, der vækker stor bekymring hos dig eller andre, for eksempel en øget seksualdrift.
- Altered or increased sexual interest and behaviour of significant concern to you or to others, for example, an increased sexual drive.
I så fald skal du kun tage tabletter en eller to gange daglig.
In this case, you will have to take the tablets only once or twice a day.
Virkningen blev påvist bevaret hos patienter behandlet i 33 uger.
Maintenance of efficacy was shown in patients treated for 33 weeks.
Ud af disse 87 patienter, fik 82,8% uændret dosis, 13,8% fik forøget dosis og 3,4% fik nedsat dosis.
Out of these 87 patients, 82.8% did not change their dose, 13.8% increased and 3.4% decreased their dose.
- Stærk trang til at spille (sygelig spilletrang) trods alvorlige personlige og familiemæssige konsekvenser.
- Strong impulse to gamble excessively despite serious personal or family consequences.
Hvis du gør det, er der risiko for overdosering, da medicinen derved kan blive frigivet for hurtigt i kroppen.
If you do, there is a danger you could overdose, because the medicine may be released into your body too quickly.
Augmentation blev specielt undersøgt i et kontrolleret klinisk forsøg på 26 uger.
Augmentation was specifically investigated in a controlled clinical trial over 26 weeks.
Derfor er interaktioner med andre lægemidler, der påvirker plasmaproteinbinding eller elimination ved biotransformation, usandsynlig.
Therefore, interactions with other medicinal products affecting plasma protein binding or elimination by biotransformation are unlikely.
Fortæl det til lægen, hvis du finder tabletstykker i din afføring.
Inform your doctor if you find tablet pieces in your faeces.
Stigningen i Cmax vurderes ikke at være klinisk relevant.
The increase in Cmax is not considered clinically relevant.
- Ukontrollerbart overdrevent indkøbsmønster og forbrug.
- Uncontrollable excessive shopping or spending.
Forsigtighed bør udvises, og omhyggelig vurdering af det terapeutiske respons samt tolerabilitet bør foretages inden dosis optrappes til dosering hver dag efter 1 uge.
Caution should be exercised and careful assessment of therapeutic response and tolerability should be made before increasing to daily dosing after one week.
Med 95% sikkerhed er frekvenskategorien ikke højere end “ikke almindelig” og kan være lavere.
With 95 % certainty, the frequency category is not greater than uncommon, but might be lower.
Den potentielle virkning af pramipexol på den reproduktive funktion er blevet undersøgt i rotter og kaniner.
The potential effects of pramipexole on reproductive function have been investigated in rats and rabbits.
Tabel 1: Parkinsons sygdom Kropssystem Meget almindelig
Table 1: Parkinson's disease Body System Very common
Hvis patienter indberetter sådan en observation, skal lægen revurdere patientens behandlingsrespons.
If patients report such an observation, the physician should reassess patient's response to therapy.
Den absolutte biotilgængelighed er større end 90%, og maksimal plasmakoncentration opnås efter 1-3 timer.
The absolute bioavailability is greater than 90% and the maximum plasma concentrations occur between 1 and 3 hours.
Sidstnævnte fund blev hverken observeret i pigmenterede rotter eller i albinomus i et karcinogenitetsstudie over 2 år eller hos nogen anden undersøgt dyreart.
The latter finding was not observed in pigmented rats, nor in a 2-year albino mouse carcinogenicity study or in any other species investigated.
Hvis dette sker, kan det være, at lægen vil ændre din medicin.
If this happens, your doctor may want to change your medication.
Den daglige dosis, du tager af Oprymea, øges hver uge.
The daily dose you take of Oprymea increases each week.
Hvis nyrefunktionen aftager under vedligeholdelsesbehandlingen, bør ovennævnte anbefalinger følges.
If renal function declines during maintenance therapy, the recommendations given above should be followed.
Denne bivirkning er observeret efter markedsføring.
This side effect has been observed in post-marketing experience.
Derfor bør du ikke tage Oprymea, hvis du er gravid, medmindre din læge anbefaler dig at gøre det.
Therefore, do not take Oprymea if you are pregnant unless your doctor tells you to do so.
Din læge vil tale med dig, om du skal fortsætte med at tage Oprymea.
Your doctor will then discuss with you if you should continue to take Oprymea.
ÆSKE TIL BLISTRE
BOX for blisters
Tilfælde af pludseligt opstået søvn under daglige aktiviteter, i nogle tilfælde uden nogen form for advarsel, har været rapporteret.
Sudden onset of sleep during daily activities, in some cases without awareness or warning signs, has been reported uncommonly.
Hos halvdelen af de 16 patienter, som ikke opfyldte kriteriet for vedvarende virkning i UPDRS del II+III-score, blev ændringen fra baseline betragtet som ikke klinisk relevant.
In half of the 16 patients who did not meet the criterion for maintained efficacy on UPDRS Part II+III score, the change from baseline was considered not clinically relevant.
Kaplan-Meier analyse af tid til augmentation viste ingen signifikant forskel mellem pramipexol- og placebogruppen.
Kaplan-Meier analysis of time to augmentation showed no significant difference between pramipexole and placebo groups.
Oprymea behandlingsstart pakken indeholder tre blisterark med tabletter - et ark for hver af de første tre uger af din behandling.
The Oprymea treatment initiation pack contains three blister strips of tablets - one strip for each of the first three weeks of your treatment.
Et vægtab på 30 kg viste en Cmax-stigning på 45%.
A decreased body weight by 30 kg results in an increase in Cmax of 45%.
Patienter med nyresygdomme Hvis du har en alvorlig nyresygdom, er Oprymea måske ikke den egnede behandling for dig.
Patients with kidney disease If you have severe kidney disease, Oprymea may not be a suitable treatment for you.
Farmakoterapeutisk klassifikation: Anti-Parkinson lægemiddel, dopaminreceptoragonist, ATC kode: N04BC05
Pharmacotherapeutic group: anti-Parkinson drugs, dopamine agonists, ATC code: N04BC05.
Meget sjælden
Rare to
Oprymea bør ikke anvendes under graviditeten, medmindre det er strengt nødvendigt, og hvis fordelene opvejer den potentielle risiko for fostret.
Oprymea should not be used during pregnancy unless clearly necessary, i.e. if the potential benefit justifies the potential risk to the foetus.
Den totale clearance for pramipexol er omkring 500 ml/min og den renale clearance er omkring 400 ml/min.
The total clearance of pramipexole is approximately 500 ml/min and the renal clearance is approximately 400 ml/min.
Literaturen rapporterer, at behandling af restless legs syndrom med dopaminerge lægemidler kan resultere i augmentation.
Reports in the literature indicate that treatment of Restless Legs Syndrome with dopaminergic medicinal products can result in augmentation.
Hypotension kan forekomme i begyndelsen af behandlingen, specielt hvis pramipexol optitreres for hurtigt.
Hypotension may occur at the beginning of treatment, especially if pramipexole is titrated too fast.
Det anbefales at monitorere blodtrykket, særlig i starten af behandlingen, pga. risikoen for hypotention i forbindelse med dopaminbehandling.
It is recommended to monitor blood pressure, especially at the beginning of treatment, due to the general risk of postural hypotension associated with dopaminergic therapy.
Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge til råds, før du tager Oprymea.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Advarsler og forsigtighedsregler Kontakt lægen, før du tager Oprymea.
Warnings and precautions Talk to your doctor before taking Oprymea.
Meget almindelig: - Kvalme
Very common: - Nausea (sickness).
Fortæl din læge, hvis du eller din familie/pårørende bemærker, at du er ved at udvikle trang til at opføre dig på måder, der er usædvanlige for dig, og du ikke kan modstå trangen eller fristelsen til at udføre visse aktiviteter, der kan skade dig selv eller andre.
Tell your doctor if you or your family/carer notices that you are developing urges or cravings to behave in ways that are unusual for you and you cannot resist the impulse, drive or temptation to carry out certain activities that could harm yourself or others.
Klinisk virkning og sikkerhed ved Parkinsons sygdom
Clinical efficacy and safety in Parkinson's disease
Tabel 2: Restless legs syndrom Kropssystem Meget almindelig
Table 2: Restless legs syndrome Body System Very common
Der kan opstå hallucinationer, døsighed eller somnolens.
Hallucinations or somnolence can occur.
Oprymea behandlingsstart pakken skal kun anvendes i begyndelsen af behandlingen med Oprymea.
The Oprymea treatment initiation pack is only to be used for the beginning of the treatment with Oprymea.
Augmentation blev observeret hos 11,8% af patienterne i pramipexolgruppen (N = 152) og hos 9,4% af patienterne i placebogruppen (N = 149).
Augmentation was observed in 11.8% of patients in the pramipexole group (N = 152) and 9.4% of patients in the placebo group (N = 149).
Den samlede incidens af hallucinationer og døsighed var generelt højere i optitreringsfase for pramipexol gruppen.
The overall incidence of hallucinations and somnolence was generally higher in the escalation phase with the pramipexole group.
Du kan få følgende bivirkninger:
You may experience the following side effects:
Pga. de valgte dyrearter og det begrænsede antal undersøgte parametre er pramipexols bivirkninger i forbindelse med graviditet og mandlig fertilitet ikke fuldt belyst.
Due to the selection of animal species and the limited parameters investigated, the adverse effects of pramipexole on pregnancy and male fertility have not been fully elucidated.
Tag ikke Oprymea - hvis du er allergisk over for pramipexol eller et af de øvrige indholdsstoffer i Oprymea (angivet i punkt 6.1).
Do not take Oprymea: - if you are allergic to pramipexole or any of the other ingredients of this medicine (listed in section 6).
Den justerede gennemsnitsforskel var -4,3 point (CI 95% -6,4; -2,1 procent, p-værdi <0,0001).
The adjusted mean difference was -4.3 points (CI 95% -6.4; -2.1 points, p-value <0.0001).
I et farmakoepidemiologisk forsøg var brug af pramipexol associeret med en øget risiko for hjertesvigt sammenlignet med ikke-brug af pramipexol (observeret risikoratio 1,86; 95% CI
In a pharmacoepidemiological study pramipexole use was associated with an increased risk of cardiac failure compared with non-use of pramipexole (observed risk ratio 1.86; 95% CI, 1.21
Pregelatineret majsstivelse Povidon K25
Pregelatinised maize starch Povidone K25
Almindelig (≥1/100 til
Common (≥1/100 to
Anvendelse af Oprymea tabletter bør overvejes i stedet.
The use of Oprymea tablets should be considered.
Kvalme og træthed blev oftere rapporteret hos kvindelige patienter behandlet med Oprymea (henholdsvis 20,8% og 10,5%) sammenlignet med mandlige patienter (henholdsvis 6,7% og 7,3%).
Nausea and fatigue were more often reported in female patients (20.8% and 10.5%, respectively) compared to males (6.7% and 7.3%, respectively).
Tabletterne bør synkes hele med vand og må ikke tygges, deles eller knuses.
The tablets should be swallowed whole with water, and must not be chewed, divided or crushed.
Fald i det diastoliske og systoliske blodtryk og hjerterytmen blev fundet i minigrise, og en tendens til en hypotensiv virkning blev set i aber.
Decreases in diastolic and systolic pressure and heart rate were noted in the minipig, and a tendency to a hypotensive effect was discerned in the monkey.
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 dose.