natgillin/translations-raw huggingface dataset:
Oplysninger fra undersøgelsen om anvendelse med særlig udleveringstilladelse hos patienter med homozygot familiær hyperkolesterolæmi er også medtaget i dette punkt.
Information from the compassionateuse study in the homozygous familial hypercholesterolaemia patient population has also been included in this section.
Indehaveren af markedsføringstilladelsen har anvendt den gensidigt anerkendte tekst som det harmoniserede produktresumé, inklusive den foreslåede harmoniserede formulering for særlige patientgrupper som ældre, børn og unge, kønsforskelle, patienter med nedsat nyre- og leverfunktion samt SLOC1B1-polymorfisme (og dens indvirkning på atorvastatin-eksponering) er medtaget.
The MAH has used the MRP text as the harmonised SmPC including the proposed harmonised wording for special populations such as the elderly, paediatrics, gender differences, patients with renal and hepatic insufficiency and SLOC1B1 polymorphism (and its effects on atorvastatin exposure) have been included.
Patienten bør sættes på en standardkolesterolsænkende diæt, inden der gives {PRODUKTNAVN}.
The patient should be placed on a standard cholesterol-lowering diet before receiving {PRODUCT NAME} and should continue on this diet during treatment with {PRODUCT NAME}.
Indehaveren af markedsføringstilladelsen har fremlagt tilstrækkelig dokumentation for de foreslåede dosisanbefalinger for atorvastatin ved specifikke antal gange stigninger i atorvastatineksponering under samtidig administration med interagerende lægemidler.
The MAH has provided satisfactory justification for the proposed atorvastatin dosing recommendations associated with the specific fold-increases of atorvastatin exposure during coadministration with the interacting drugs.
"Nedsat nyrefunktion Dosisjustering er ikke påkrævet (se pkt.
‘Renal impairment No adjustment of dose is required (see section 4.4).
Højere dosis kan være nødvendig for at opnå LDL-kolesterolniveauer i henhold til gældende retningslinjer………………
Higher doses may be necessary in order to attain (LDL-) cholesterol levels according to current guidelines……………… Method of administration {PRODUCT NAME} is for oral administration.
Startdosis er sædvanligvis 10 mg én gang dagligt.
The usual starting dose is 10 mg once a day.
- under graviditet og amning og hos kvinder i den fertile alder, som ikke benytter sikker antikonception (se pkt.
- during pregnancy, while breast-feeding and in women of child-bearing potential not using appropriate contraceptive measures (see section 4.6).'
For indikationen vedrørende forebyggelse af kardiovaskulær sygdom tages doseringsinformationen fra det gensidigt anerkendte produktresumé.
For the indication relating to the prevention of cardiovascular disease, the dosing information is taken from the MRP SmPC.
Der blev inkluderet en kontraindikation for patienter under graviditet og amning og for fertile kvinder, som ikke benytter sikker antikonception.
A contraindication in patients during pregnancy, while breast-feeding and in women of child-bearing potential not using appropriate contraceptive measures was included.
Henvisningen til nefazodon som samtidig behandling er fjernet efter anmodning fra CHMP.
As requested by the CHMP the reference to nefazodone as a concomitant treatment was removed.
Indehaveren af markedsføringstilladelsen har anvendt den gensidigt anerkendte produktresumétekst som den foreslåede harmoniserede produktresumétekst, da overdoseringsformuleringen i medlemsstaternes produktresuméer stort set er identisk med den nuværende gensidigt anerkendte produktresumétekst.
The MAH has used the MRP SmPC text as the proposed harmonised SmPC text as the overdose wording across the Member State SmPCs is essentially identical to the current MRP SmPC text.
4.5 (tekst og tabelformater) er flyttet rundt, således at lægemiddelinteraktionerne nu er grupperet under enten “Samtidigt administrerede lægemidlers indvirkning på atorvastatin” eller “Atorvastatins virkning på samtidigt administrerede lægemidler”.
The information in Section 4.5 (text and table formats) has been rearranged such that drug interactions are now grouped under either “Effect of co-administered drugs on atorvastatin” or “Effect of atorvastatin on co-administered drugs.” As requested by the CHMP, the MAH has included mechanistic information and extrapolations.
Der skelnes ikke i doseringsanbefalingerne for behandling af hyperkolesterolæmi med hensyn til startdosisregime og dosistitrering i intervaller på 4 uger.
Section 4.2 - Posology and method of administration No differences are made in dosing recommendations for the treatment of hypercholesterolaemia related to the starting dose regimen and the dose titration in 4 week intervals.
Kliniske oplysninger
Clinical particulars
Børn og unge Børn og unge bør kun behandles af specialister.
Paediatric use Paediatric use should only be carried out by specialists.
Nedsat leverfunktion {PRODUKTNAVN} bør anvendes med forsigtighed til patienter med nedsat leverfunktion (se pkt.
Hepatic impairment {PRODUCT NAME} should be used with caution in patients with hepatic impairment (see sections 4.4 and 5.2).
CHMP godkendte indehaveren af markedsføringstilladelsens forslag.
The CHMP agreed with the MAH's proposal.
• produktresuméet, etiketteringen og indlægssedlen, som indehaveren af markedsføringstilladelsen har foreslået, er blevet vurderet på baggrund af den fremsendte dokumentation og udvalgets videnskabelige drøftelse,
• 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 Lipitor and associated names (see Annex I).
Forebyggelse af kardiovaskulære hændelser hos patienter, som vurderes at have en høj risiko for debut af en kardiovaskulær hændelse (se pkt.
Prevention of cardiovascular events in patients estimated to have a high risk for a first cardiovascular event (see section 5.1), as an adjunct to correction of other risk factors.'
4.4, hvor der henvises til forsigtighedsreglerne ved nedsat nyrefunktion i anamnesen som en potentiel risikofaktor for at udvikle rhabdomyolyse og anbefaling af tættere overvågning af muskelsymptomer.
The MAH considered it important that physicians be aware of the potential increased risk in this population and monitor these patients for skeletal muscle effects, and a cross-reference to section 4.4 has been added referring to precautionary information regarding patient history of renal impairment as a potential risk factor for development of rhabdomyolysis and recommending closer monitoring for muscle symptoms.
- Oplysningerne fra en undersøgelse af anvendelse med særlig udleveringstilladelse hos patienter med homozygot familiær hyperkolesterolæmi er flyttet til pkt.
- The information derived from a compassionate use study in the homozygous familial hypercholesterolemia patient population has been moved to section 5.1 as suggested by the CHMP.
Indehaveren af markedsføringstilladelsen foreslår, at kontraindikationen til patienter under graviditet og amning og til fertile kvinder, som ikke benytter sikker antikonception, medtages med krydshenvisning til pkt.
The MAH proposes the inclusion of the contraindication in patients during pregnancy, while breastfeeding and in women of childbearing potential not using appropriate contraceptive measures with a cross reference to section 4.3 of the SmPC.
Størstedelen af patienterne er velkontrollerede med {PRODUKTNAVN} 10 mg én gang dagligt.
Primary hypercholesterolaemia and combined (mixed) hyperlipidaemia The majority of patients are controlled with {PRODUCT NAME} 10 mg once a day.
- Indehaveren af markedsføringstilladelsen fulgte CHMP's anmodning om at medtage en forsigtighedsregel for patienter med nedsat leverfunktion i pkt.
- The MAH has followed the request by the CHMP to include a recommendation for caution for patients with hepatic impairment in section 4.2, with cross references to sections 4.4 and 5.2 of the harmonised SmPC.
• Alle sundhedsfaglige personer, der har til hensigt at ordinere og/eller udlevere Opsumit, inden ordination (når det er hensigtsmæssigt og i overensstemmelse med den nationale kompetente myndighed), får udleveret et ordinationssæt der indeholder følgende: o Informations sæt til sundhedspersonale o Informations brochure til patienter o Patientkort o Produktresumé, indlægsseddel og etikettering.
• Prior to prescribing (where appropriate, and in agreement with the National Competent Authority, dispensing) all healthcare professionals who intend to prescribe (and dispense) are provided with a prescriber kit containing the following: o Educational Health Care Professional's kit o Educational brochures for Patients o Patient cards o Summary of Product Characteristics (SmPC) and Package Leaflet and Labelling.
Annex relateret til artikel 127a Betingelser eller begrænsninger med hensyn til en sikker og effektiv anvendelse af lægemidlet, som skal implementeres af medlemslandet
Annex related to the Art. 127a Conditions or restrictions with regard to the safe and effective use of the medicinal product to be implemented by the Member States
Medlemslandet skal aftale detaljerne i ordinationssættet og et kontrolleret distributionssystem med indehaveren af markedsføringstilladelsen og implementere det inden lancering nationalt for at sikre at:
Conditions or restrictions with regard to the safe and effective use of the medicinal product to be implemented by the Member States The Member States should ensure that all conditions or restrictions with regard to the safe and effective use of the medicinal product described below are implemented: The Member State shall agree the details of the Prescriber kit and a controlled distribution system with the Marketing Authorisation Holder (MAH) and must implement such programme nationally prior to launch to ensure that:
Hvis De har alvorlige nyreproblemer, bør De ikke tage Urorec.
If you have severe kidney problems, you should not take Urorec.
Hvis de har moderate nyreproblemer, vil Deres læge begynde behandlingen med Urorec med forsigtighed og muligvis med en lavere dosis (se punkt 3 “Dosis”).
If you have moderate kidney problems, your doctor will start Urorec with caution and possibly with a lower dose (see section 3 “Dose”).
Urorec påvirker i mindre eller moderat grad evnen til at føre motorkøretøj og betjene maskiner.
Urorec has minor or moderate influence on the ability to drive and use machines.
Denne virkning forsvinder, når behandlingen med Urorec ophører.
This effect disappears after discontinuation of Urorec.
Der er utilstrækkelig information om sikker anvendelse af silodosin i forbindelse med andre α-adrenoreceptorantagonister.
There is inadequate information about the safe use of silodosin in association with other α-adrenoreceptor antagonists.
Forskel (95 % KI) versus placebo
Difference (95 % CI) vs placebo
Urorec tilhører en gruppe af lægemidler, der kaldes alfa1A-adrenoreceptorblokkere.
Urorec belongs to a group of medicines called alpha1A-adrenoreceptor blockers.
Hvis De oplever svimmelhed, når De rejser Dem op, og hvis De besvimer ind imellem, når De tager Urorec, specielt når De begynder med behandlingen, eller hvis De tager andre lægemidler, der sænker blodtrykket.
Dizziness when standing up and occasionally fainting may occur when taking Urorec, particularly when starting treatment or if you are taking other medicines that lower blood pressure.
Det er vigtigt, at De straks informerer Deres øjenspecialist, hvis De tager eller tidligere har taget Urorec.
It is important that you immediately inform your eye specialist if you are using or have previously used Urorec.
Det skal De vide, før De begynder at tage Urorec Tag ikke Urorec hvis De er allergisk over for silodosin eller et af de øvrige indholdsstoffer i Urorec (angivet i punkt 6).
What you need to know before you take Urorec Do not take Urorec if you are allergic to silodosin or any of the other ingredients of this medicine (listed in section 6).
Spørg Deres læge om De bør udskyde eller midlertidigt stoppe med at tage Urorec, hvis De skal gennemgå en operation for grå stær.
Ask your doctor whether or not you should postpone or temporarily stop taking Urorec when undergoing cataract surgery.
• Da en godartet forstørrelse af blærehalskirtlen og prostatakræft kan have de samme symptomer, vil Deres læge undersøge Dem for prostatakræft, før De begynder behandlingen med Urorec.
• Since a benign enlargement of the prostate and prostate cancer may present the same symptoms, your doctor will check you for prostate cancer before starting treatment with Urorec.
Gul jernoxid (E172) (kun 4 mg kapsel)
Yellow iron oxide (E172) (4 mg capsules only)
Til specielle patientpopulationer anbefales en kapsel Urorec 4 mg dagligt (se nedenfor).
For special patient populations, one capsule of Urorec 4 mg daily is recommended (see below).
• Hvis De har alvorlige leverproblemer, bør De ikke tage Urorec, da det ikke er undersøgt i forbindelse med alvorlig leversygdom.
• If you have severe liver problems, you should not take Urorec, as it was not tested in this condition.
Dato for første markedsføringstilladelse: 29/01/2010 Dato for seneste fornyelse: 18/09/2014
Date of latest renewal: 18/09/2014
Kontakt lægen eller apotekspersonalet, før De tager Urorec.
Talk to your doctor or pharmacist before taking Urorec
• Hvis De skal gennemgå en øjenoperation på grund af uklarhed af linsen (operation for grå stær), er det vigtigt, at De straks informerer Deres øjenspecialist om, at De tager eller tidligere har taget Urorec.
• If you are undergoing eye surgery because of cloudiness of the lens (cataract surgery), it is important that you immediately inform your eye specialist that you are using or have previously used Urorec.
Urorec kan forårsage komplikationer under en operation for grå stær (øjenoperation på grund af en uklar linse, se punktet “Advarsler og forsigtighedsregler”).
Urorec may cause complications during a cataract surgery (eye surgery because of cloudiness of the lens, see section “Warnings and precautions”).
Urorec er kun beregnet til brug hos mænd.
Urorec is not intended for use by women.
• medicin mod epilepsi eller rifampicin (medicin til behandling af tuberkulose), da virkningen af Urorec kan være nedsat.
• medicines for epilepsy or rifampicin (a medicine to treat tubercolosis), since the effect of Urorec may be reduced.
Urorec findes i pakningsstørrelser med 5, 10, 20, 30, 50, 90 og 100 kapsler.
Urorec is available in packs containing 5, 10, 20, 30, 50, 90, 100 capsules.
• medicin, der sænker blodtrykket (især medicin kaldet alfa1-blokkere, såsom prazosin eller doxazosin), da der kan være en risiko for at virkningen af sådanne former for medicin forstærkes, mens De tager Urorec.
• medicines which lower blood pressure (in particular, medicines called alpha1-blockers, such as prazosin or doxazosin) as there may be the potential risk that the effect of these medicines is increased whilst taking Urorec.
• Hvis De på noget tidspunkt er besvimet eller har følt Dem svimmel, når De pludseligt rejser Dem op, skal De informere lægen før De tager Urorec.
• If you have ever fainted or felt dizzy when suddenly standing up, please inform your doctor before taking Urorec.
Hvis De holder op med at tage Urorec
If you stop taking Urorec
I et klinisk fase IV-studie, der blev udført i Europa, med en gennemsnitlig IPSS total-score ved baseline på 18,9 points, havde 77,1 % respons på silodosin (vurderet ved en ændring i IPSS total-score fra baseline på mindst 25 %).
In a Phase IV clinical trial performed in Europe, with a mean baseline IPSS total score of 18.9 points, 77.1%were responders to silodosin (as assessed by a change from baseline in the IPSS total score of at least 25%).
Efter oral administration af 14C-mærket silodosin blev ca. 33,5 % og 54,9 % af radioaktiviteten genfundet i henholdsvis urin og afføring efter 7 dage.
Elimination Following oral administration of 14C-labelled silodosin, the recovery of radioactivity after 7 days was approximately 33.5% in urine and 54.9% in faeces.
Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med med referencelægemidlet, som indeholder Urorec i alle undergrupper af den pædiatriske population med BPH (se pkt.
The European Medicines Agency has waived the obligation to submit the results of studies with Urorec in all subsets of the paediatric population in BPH (see section 4.2 for information on paediatric use).
Urorec kan ikke anvendes til at behandle prostatakræft.
Urorec does not treat prostate cancer.
Over 800 patienter med moderate til svære symptomer på BPH (International Prostate Symptom Score, IPSS, baseline-værdi ≥ 13) fik silodosin 8 mg én gang dagligt i to placebo-kontrollerede kliniske fase III-studier udført i USA, og i et placebo-kontrolleret og aktivt kontrolleret klinisk studie udført i Europa.
Over 800 patients with moderate to severe symptoms of BPH (International Prostate Symptom Score, IPSS, baseline value ≥13) received silodosin 8 mg once daily in two Phase III placebo-controlled clinical studies conducted in the United States and in one placebo- and active-controlled clinical study conducted in Europe.
Hvis De har glemt at tage Urorec
If you forget to take Urorec
Urorec anvendes hos voksne mænd for at behandle urinsvejssymptomer forbundet med en godartet forstørrelse af blærehalskirtlen (prostatahyperplasi), såsom:
Urorec is used in adult men to treat the urinary symptoms associated with benign enlargement of the prostate (prostatic hyperplasia), such as:
• medicin til behandling af problemer med at få og opretholde en erektion (såsom sildenafil eller tadalafil), da samtidig anvendelse med Urorec kan føre til et let blodtryksfald.
• medicines used for treating problems in getting or keeping an erection (such as sildenafil or tadalafil), since the concomitant use with Urorec might lead to a slight decrease in blood pressure.
• medicin mod svampeinfektion (såsom ketoconazol eller itraconazol), medicin der anvendes mod HIV-infektion/AIDS (såsom ritonavir) eller medicin der anvendes efter transplantationer for at forhindre organafstødning (såsom ciclosporin), da disse former for medicin kan forhøje koncentrationen af Urorec i blodet.
• antifungal medicines (such as ketoconazole or itraconazole), medicines used for HIV-AIDS (such as ritonavir) or medicines used after transplants to prevent organ rejection (such as cyclosporin) because these medicines can increase the blood concentration of Urorec.
Det er ikke relevant at anvende Urorec hos den pædiatriske population til indikationen godartet prostatahyperplasi (BPH).
There is no relevant use of Urorec in the paediatric population for the indication of benign prostatic hyperplasia (BPH).
• Behandling med Urorec kan føre til unormal ejakulation (reduktion i mængden af sæd, der frigives under samleje), hvilket midlertidigt kan påvirke den mandlige frugtbarhed.
• The treatment with Urorec may lead to an abnormal ejaculation (decrease in the amount of semen released during sex) that may temporarily affect male fertility.
I et dobbelt-blindet, placebo-kontrolleret klinisk dose-finding, fase II-studie med silodosin 4 eller 8 mg én gang dagligt, blev der observeret en større forbedring i index score af symptomer i henhold til American Urologic Association (AUA) med silodosin 8 mg (-6,8 ± 5,8; n = 90; p = 0,0018) og silodosin 4 mg (-5,7 ± 5,5; n= 88; p = 0,0355) sammenlignet med placebo (-4,0 ± 5,5; n = 83).
In a Phase II dose-finding, double-blind, placebo-controlled clinical study with silodosin 4 or 8 mg once daily, a greater improvement in American Urologic Association (AUA) symptom index score was observed with silodosin 8 mg (-6.8 ± 5.8, n = 90; p = 0.0018) and silodosin 4 mg (-5.7 ± 5.5, n = 88; p = 0.0355) as compared to placebo (-4.0 ± 5.5, n = 83).
Potente CYP3A4-hæmmere (såsom ketoconazol, itraconazol, ritonavir eller ciclosporin) bør ikke anvendes samtidig med Urorec.
Concomitant use with potent CYP3A4 inhibitors (such as ketoconazole, itraconazole, ritonavir or cyclosporine) is not recommended.
Urorec kan nedsætte mængden af sædceller og dermed midlertidigt påvirke Deres evne til at gøre en kvinde gravid.
Urorec may reduce the amount of sperm, and so could temporarily affect your ability to father a child.
Den anbefalede dosis er én kapsel Urorec 8 mg dagligt.
The recommended dose is one capsule of Urorec 8 mg daily.
Herbacos Recordati s.r.o.
Česká republika Herbacos Recordati s.r.o.
Da der kun er begrænset erfaring med patienter med moderat nedsat nyrefunktion (n = 35), anbefales en lavere startdosis på 4 mg. Urorec bør ikke anvendes til patienter med svært nedsat nyrefunktion.
Since only limited experience exists in patients with moderate renal impairment (n = 35), a lower starting dose of 4 mg is recommended.
Brug af anden medicin sammen med Urorec
Other medicines and Urorec
Til dette formål findes Urorec 4 mg hårde kapsler.
For this purpose Urorec 4 mg hard capsules are available.
SÆRLIG ADVARSEL OM, AT LÆGEMIDLET SKAL OPBEVARES UTILGÆNGELIGT FOR BØRN
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN Keep out of the sight and reach of children.
Urorec påvirker nogle receptorer, som findes i blærehalskirtlen, blæren og urinrøret.
Urorec is selective for the receptors located in the prostate, bladder and urethra.
Den anbefalede dosis er en kapsel Urorec 8 mg pr. dag givet oralt (gennem munden).
The recommended dose is one capsule of Urorec 8 mg per day by oral administration.
Urorec 4 mg er gule, uigennemsigtige, hårde gelatinekapsler, størrelse 3 (cirka 15,9 x 5,8 mm).
Urorec 4 mg are yellow, opaque, hard gelatin capsules, size 3 (approximately 15.9 x 5.8 mm).
17 ENTYDIG IDENTIFIKATOR - 2D-STREGKODE
UNIQUE IDENTIFIER - 2D BARCODE 2D barcode carrying the unique identifier included
Urorec 4 mg og 8 mg hårde kapsler
Urorec 4 mg and 8 mg hard capsules
Urorec 4 mg hårde kapsler Hver hård kapsel indeholder 4 mg silodosin.
Urorec 4 mg hard capsules Each hard capsule contains 4 mg silodosin.
Urorec 8 mg hårde kapsler Hver hård kapsel indeholder 8 mg silodosin.
Urorec 8 mg hard capsules Each hard capsule contains 8 mg silodosin.
Urorec 8 mg er hvide, uigennemsigtige, hårde gelatinekapsler, størrelse 0 (cirka 21,7 x 7,6 mm).
What Urorec looks like and contents of the pack Urorec 8 mg are white, opaque, hard gelatin capsules, size 0 (approximately 21.7 x 7.6 mm).
Sådan skal De tage Urorec
How to take Urorec
EU/1/09/608/001 EU/1/09/608/002 EU/1/09/608/003 EU/1/09/608/004 EU/1/09/608/005 EU/1/09/608/006 EU/1/09/608/007 EU/1/09/608/008 EU/1/09/608/009 EU/1/09/608/010
EU/1/09/608/001 EU/1/09/608/002 EU/1/09/608/003 EU/1/09/608/004 EU/1/09/608/005 EU/1/09/608/006 EU/1/09/608/007 EU/1/09/608/008 EU/1/09/608/009 EU/1/09/608/010 EU/1/09/608/011 EU/1/09/608/012 EU/1/09/608/013 EU/1/09/608/014
Tél: + 33 1 45 19 10 00
Laboratoires Bouchara-Recordati Tél: + 33 1 45 19 10 00
DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 29/01/2010
Urorec 4 mg hårde kapsler
Urorec 4 mg hard capsules
Urorec 4 mg hårde kapsler Urorec 8 mg hårde kapsler
Urorec 8 mg hard capsules Urorec 4 mg hard capsules
Urorec 8 mg hårde kapsler
Urorec 8 mg hard capsules
Det skal De vide, før De begynder at tage Urorec Sådan skal De tage Urorec Bivirkninger
What Urorec is and what it is used for What you need to know before you take Urorec How to take Urorec
Urorec 4 mg hårde kapsler silodosin
NAME OF THE MEDICINAL PRODUCT Urorec 4 mg hard capsules silodosin
Urorec 8 mg hårde kapsler silodosin
NAME OF THE MEDICINAL PRODUCT Urorec 8 mg hard capsules silodosin
Urorecs anvendelse
What Urorec is
INFORMATION I BRAILLESKRIFT
INFORMATION IN BRAILLE Urorec 4 mg
Hvis De har taget for meget Urorec
If you take more Urorec than you should
Urorec 4 mg Aktivt stof: silodosin.
The active substance is silodosin.
Indlægsseddel: Information til patienten Urorec 8 mg hårde kapsler
NAME OF THE MEDICINAL PRODUCT Urorec 4 mg hard capsules