FrancophonIA/ELRC3.0 huggingface dataset:
English: - The other ingredients are metacresol, glycerol, dibasic sodium phosphate 7 H2O, zinc oxide and water for injections.
Danish: - De øvrige indholdsstoffer er metacresol, glycerol, dinatriumphosphat heptahydrat, zinkoxid og vand til injektionsvæsker.
English: NAME OF THE MEDICINAL PRODUCT Liprolog Mix25 100 units/ml KwikPen suspension for injection in a pre-filled pen 25% insulin lispro and 75% insulin lispro protamine suspension
Danish: Liprolog Mix25 100 enheder/ml KwikPen, injektionsvæske, suspension, i fyldt pen 25% insulin lispro og 75% insulin lispro protaminsuspension
English: Insulin lispro is made in the laboratory by a ‘recombinant DNA technology' process.
Danish: Insulin lispro er fremstillet ved gensplejsning.
English: What Liprolog 100 units/ml Junior KwikPen solution for injection contains - The active substance is insulin lispro.
Danish: Liprolog 100 enheder/ml Junior KwikPen, injektionsvæske, opløsning indeholder: - Det aktive stof er insulin lispro.
English: Step 14: • Carefully replace the Outer Needle Shield.
Danish: Trin 4: • Træk den ydre nålehætte af og behold den.
English: (see also section “Warnings and precautions”).
Danish: Dette gælder også medicin, som ikke er købt på recept (se punkt ”Advarsler og forsigtighedsregler”).
English: Marketing Authorisation Holder and Manufacturer Liprolog 100 units/ml, solution for injection in vial is made by:
Danish: Indehaver af markedsføringstilladelsen og fremstiller Liprolog 100 enheder/ml, injektionsvæske, opløsning, i cylinderampul fremstilles af:
English: What Liprolog 200 units/ml KwikPen solution for injection contains - The active substance is insulin lispro.
Danish: Liprolog 200 enheder/ml KwikPen, injektionsvæske, opløsning indeholder: - Det aktive stof er insulin lispro.
English: The product licence is held by: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands.
Danish: Indehaver af markedsføringstilladelsen er: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, Holland.
English: The rapid onset and early peak of activity of Liprolog itself is observed following the subcutaneous administration of Liprolog Mix25.
Danish: Den hurtigt indsættende virkning og det tidlige aktivitetsmaksimum af Liprolog observeres også efter subkutan administration af Liprolog Mix25.
English: Package leaflet: Information for the user Liprolog 200 units/ml KwikPen, solution for injection in a pre-filled pen insulin lispro Each KwikPen delivers 1 - 60 units in steps of 1 units.
Danish: Indlægsseddel: Information til brugeren Liprolog 200 enheder/ml KwikPen, injektionsvæske, opløsning, i fyldt pen insulin lispro Hver KwikPen leverer 1 - 60 enheder i trin af 1 enhed.
English: The rapid onset and early peak of activity of Liprolog itself is observed following the subcutaneous administration of Liprolog Mix50.
Danish: Den hurtigt indsættende virkning og det tidlige aktivitetsmaksimum af Liprolog observeres også efter subkutan administration af Liprolog Mix50.
English: MARKETING AUTHORISATION NUMBER EU/1/01/195/029
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/01/195/029
English: MARKETING AUTHORISATION NUMBER EU/1/01/195/020
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/01/195/020
English: Each pre-filled pen contains 300 units of insulin lispro in 3 ml solution.
Danish: Hver fyldt pen indeholder 300 enheder insulin lispro i 3 ml opløsning.
English: MARKETING AUTHORISATION NUMBERS EU/1/01/195/002
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/01/195/002
English: MARKETING AUTHORISATION NUMBER EU/1/01/195/009
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/01/195/009
English: MARKETING AUTHORISATION NUMBERS EU/1/01/195/004
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/01/195/004
English: Further in this leaflet it tells you how to deal with mild hypoglycaemia (see section 3: If you take more Liprolog than you need).
Danish: Senere i denne indlægsseddel beskrives, hvordan du skal behandle et let tilfælde af hypoglykæmi (se punkt 3: Hvis du har taget for meget Liprolog KwikPen).
English: • Warnings and precautions
Danish: • kvalme og opkastning
English: Marketing Authorisation Holder and Manufacturer Liprolog 100 units/ml KwikPen, solution for injection is made by:
Danish: Indehaver af markedsføringstilladelsen og fremstiller Liprolog 100 enheder/ml KwikPen, injektionsvæske, opløsning, fremstilles af:
English: MARKETING AUTHORISATION NUMBER EU/1/01/195/030
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/01/195/030
English: If you think you are having this sort of insulin allergy with Liprolog, tell your doctor at once.
Danish: • svedtendens Hvis du tror, at du har denne form for insulinallergi med Liprolog, skal du straks informere din læge.
English: Liprolog Mix25 100 units/ml KwikPen, suspension for injection is a white, sterile suspension and contains 100 units of insulin lispro in each millilitre (100 units/ml) suspension for injection.
Danish: Liprolog Mix25 100 enheder/ml KwikPen, injektionsvæske, suspension er en steril hvid suspension og indeholder 100 enheder insulin lispro per milliliter (100 enheder/ml) injektionsvæske.
English: Liprolog Mix50 100 units/ml KwikPen, suspension for injection is a white, sterile suspension and contains 100 units of insulin lispro in each millilitre (100 units/ml) suspension for injection.
Danish: Liprolog Mix50 100 enheder/ml KwikPen, injektionsvæske, suspension er en steril hvid suspension og indeholder 100 enheder insulin lispro per milliliter (100 enheder/ml) injektionsvæske.
English: Liprolog 100 units/ml KwikPen solution for injection in a pre-filled pen Insulin lispro
Danish: Liprolog 100 enheder/ml KwikPen, injektionsvæske, opløsning, i fyldt pen insulin lispro
English: What Liprolog is and what it is used for What you need to know before you use Liprolog How to use Liprolog
Danish: Det skal du vide, før du begynder at bruge Liprolog Sådan skal du bruge Liprolog Bivirkninger
English: MARKETING AUTHORISATION NUMBER EU/1/01/195/031
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/01/195/031
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION Liprolog Mix25 100 units/ml KwikPen suspension for injection 25% insulin lispro and 75% insulin lispro protamine suspension Subcutaneous use
Danish: Liprolog Mix25 100 enheder/ml, KwikPen injektionsvæske, suspension 25% insulin lispro og 75% insulin lispro protaminsuspension Subkutan anvendelse
English: • The KwikPen should be rotated in the palms of the hands ten times and inverted 180° ten times immediately before use to resuspend insulin until it appears uniformly cloudy or milky.
Danish: • Du skal rulle KwikPennen mellem håndfladerne ti gange og vende pennen op og ned ti gange lige før brug for at opblande insulinet.
English: What Liprolog Mix50 is and what it is used for What you need to know before you use Liprolog Mix50 How to use Liprolog Mix50
Danish: Det skal du vide, før du begynder at bruge Liprolog Mix50 Sådan skal du bruge Liprolog Mix50
English: Marketing Authorisation Holder Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands.
Danish: Indehaver af markedsføringstilladelsen Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, Holland.
English: MARKETING AUTHORISATION HOLDER Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands.
Danish: INDEHAVER AF MARKEDSFØRINGSTILLADELSEN Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, Holland.
English: MARKETING AUTHORISATION NUMBER EU/1/01/195/017
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/01/195/017
English: MARKETING AUTHORISATION NUMBER EU/1/01/195/018
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/01/195/018
English: Marketing Authorisation Holder and Manufacturer Liprolog Mix50 100 units/ml suspension for injection in cartridge is made by:
Danish: Indehaver af markedsføringstilladelsen og fremstiller Liprolog Mix50 100 enheder/ml, injektionsvæske, suspension, i cylinderampul fremstilles af:
English: Marketing Authorisation Holder and Manufacturer Liprolog Mix25 100 units/ml suspension for injection in cartridge is made by:
Danish: Indehaver af markedsføringstilladelsen og fremstiller Liprolog Mix25 100 enheder/ml, injektionsvæske, suspension, i cylinderampul fremstilles af:
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (with blue box) multipack - Vial
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE KARTON (med blå boks) multipakning - Hætteglas
English: To prevent the possible transmission of disease, each pen must be used by one patient only, even if the needle is changed.
Danish: Instruktioner vedrørende anvendelse og håndtering For at undgå overførsel af sygdomme må hver pen kun bruges af den samme patient, også selvom kanylen skiftes.
English: Each cartridge contains 300 units of insulin lispro in 3 ml solution.
Danish: Hver cylinderampul indeholder 300 enheder insulin lispro i 3 ml opløsning.
English: Renal impairment Insulin requirements may be reduced in the presence of renal impairment.
Danish: Nedsat nyrefunktion Ved nedsat nyrefunktion kan insulinbehovet være nedsat.
English: STATEMENT OF ACTIVE SUBSTANCE One ml solution contains 100 units of insulin lispro (equivalent to 3.5 mg).
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER En ml opløsning indeholder 100 enheder insulin lispro (svarende til 3,5 mg).
English: MARKETING AUTHORISATION NUMBERS EU/1/01/195/003
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/01/195/003
English: Choose your injection site.
Danish: Vælg indstikssted.
English: MARKETING AUTHORISATION NUMBER EU/1/01/195/021
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/01/195/021
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION Liprolog Mix50 100 units/ml KwikPen suspension for injection 50% insulin lispro and 50% insulin lispro protamine suspension Subcutaneous use
Danish: Liprolog Mix50 100 enheder/ml KwikPen, injektionsvæske, suspension 50% insulin lispro og 50% insulin lispro protaminsuspension Subkutan anvendelse
English: MARKETING AUTHORISATION NUMBERS EU/1/01/195/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/01/195/001
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - Cartridges.
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE KARTON - Cylinderampuller.
English: Liprolog 100 units/ml solution for injection in vial insulin lispro
Danish: Liprolog 100 enheder/ml, injektionsvæske, opløsning, i cylinderampul insulin lispro
English: What Liprolog 100 units/ml Junior KwikPen looks like and contents of the pack Liprolog 100 units/ml Junior KwikPen, solution for injection is a sterile, clear, colourless, aqueous solution and contains 100 units of insulin lispro in each millilitre (100 units/ml) solution for injection.
Danish: Liprolog 100 enheder/ml Junior KwikPen, injektionsvæske, opløsning er en steril klar farveløs vandig opløsning og indeholder 100 enheder insulin lispro per milliliter (100 enheder/ml) injektionsvæske.
English: Important information about some of the ingredients of Liprolog Mix25 This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodiumfree'.
Danish: Vigtig information om nogle af indholdsstofferne i Liprolog Mix25 KwikPen Dette lægemiddel indeholder mindre end 1 mmol (23 mg) natrium pr. dosis, dvs. det er i det væsentlige natriumfrit.
English: MARKETING AUTHORISATION NUMBER EU/1/01/195/019
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/01/195/019
English: PACKAGE LEAFLET: INFORMATION FOR THE USER Liprolog 100 units/ml KwikPen, solution for injection in a pre-filled pen insulin lispro Each KwikPen delivers 1 - 60 units in steps of 1 units.
Danish: Indlægsseddel: Information til brugeren Liprolog 100 enheder/ml KwikPen, injektionsvæske, opløsning, i fyldt pen insulin lispro Hver KwikPen leverer 1 - 60 enheder i trin af 1 enhed.
English: NAME OF THE MEDICINAL PRODUCT Liprolog Mix50 100 units/ml suspension for injection in cartridge 50% insulin lispro and 50% insulin lispro protamine suspension
Danish: Liprolog Mix50 100 enheder/ml, injektionsvæske, suspension, i cylinderampul 50% insulin lispro og 50% insulin lispro protaminsuspension
English: • wheezing
Danish: Gummimembran
English: Liprolog Mix50 100 units/ml suspension for injection is a white, sterile suspension and contains 100 units of insulin lispro in each millilitre (100 units/ml) suspension for injection.
Danish: Liprolog Mix50 100 enheder/ml, injektionsvæske, suspension er en steril hvid suspension og indeholder 100 enheder insulin lispro per milliliter (100 enheder/ml) injektionsvæske.
English: Before the first use store your Liprolog Mix25 in a refrigerator (2°C - 8°C).
Danish: Liprolog Mix25 opbevares i køleskab (2ºC - 8ºC), indtil det tages i brug for første gang.
English: Liprolog Mix25 100 units/ml suspension for injection is a white, sterile suspension and contains 100 units of insulin lispro in each millilitre (100 units/ml) suspension for injection.
Danish: Liprolog Mix25 100 enheder/ml, injektionsvæske, suspension er en steril hvid suspension og indeholder 100 enheder insulin lispro per milliliter (100 enheder/ml) injektionsvæske.
English: If you notice your skin thickening or pitting at the injection site, tell your doctor.
Danish: Informer din læge, hvis du bemærker, at din hud fortykkes eller får fordybninger ved indstiksstedet.
English: What Liprolog Mix25 100 units/ml suspension for injection in cartridge contains - The active substance is insulin lispro.
Danish: Liprolog Mix25 100 enheder/ml injektionsvæske, suspension i cylinderampul indeholder: - Aktivt stof: insulin lispro.
English: White with
Danish: Doseringsknap med
English: What Liprolog Mix50 100 units/ml suspension for injection in cartridge contains - The active substance is insulin lispro.
Danish: Liprolog Mix50 100 enheder/ml injektionsvæske, suspension i cylinderampul indeholder: - Aktivt stof: insulin lispro.
English: NAME OF THE MEDICINAL PRODUCT Liprolog Mix25 100 units/ml suspension for injection in cartridge 25% insulin lispro and 75% insulin lispro protamine suspension
Danish: Liprolog Mix25 100 enheder/ml, injektionsvæske, suspension, i cylinderampul 25% insulin lispro og 75% insulin lispro protaminsuspension
English: Turn the vial and syringe upside down.
Danish: Vend pennen op og ned 10 gange.
English: Pen Cap
Danish: Pennens hætte
English: Before the first use store your Liprolog Mix50 in a refrigerator (2°C - 8°C).
Danish: Liprolog Mix50 opbevares i køleskab (2ºC - 8ºC), indtil det tages i brug for første gang.
English: Before the first use store your Liprolog KwikPen in a refrigerator (2°C - 8°C).
Danish: Liprolog KwikPen opbevares i køleskab (2ºC - 8ºC), indtil den tages i brug.
English: France TEVA SANTE Le Palatin 1
Danish: TEVA SANTE Le Palatin 1
English: Portugal Ciclum Farma Unipessoal, Lda.
Danish: Ciclum Farma Unipessoal, Lda.
English: Germany HEXAL Aktiengesellschaft Industriestr.
Danish: HEXAL Aktiengesellschaft Industriestr.
English: Bulgaria Teva Pharmaceuticals Bulgaria EOOD
Danish: Teva Pharmaceuticals Bulgaria EOOD
English: Belgium Eurogenerics NV Heizel Esplanade b22 1020 Brussel
Danish: Eurogenerics NV Heizel Esplanade b22 1020 Brussel Belgium
English: 00-113 Warszawa
Danish: 00-113 Warszawa Poland
English: Norway Teva Sweden AB Järnvägsgatan 11, Box 1070, 251 10 Helsingborg Sweden
Danish: Teva Sweden AB Järnvägsgatan 11, Box 1070, 251 10 Helsingborg Sweden
English: Belgium Sandoz NV/SA Telecom Gardens Medialaan 40
Danish: Sandoz NV/SA Telecom Gardens Medialaan 40
English: Bad Vilbel D-61118
Danish: Bad Vilbel D-61118 Germany
English: Denmark Teva Denmark A/S, Parallelvej 10-12, DK-2800 Kongens Lyngby, Denmark
Danish: Teva Denmark A/S, Parallelvej 10-12, DK-2800 Kongens Lyngby, Denmark
English: Poland Teva Pharmaceuticals Polska Sp. z o.o.
Danish: Teva Pharmaceuticals Polska Sp. z o.o.
English: Poland Sandoz GmbH Biochemiestrasse 10 Kundl, A-6250
Danish: Sandoz GmbH Biochemiestrasse 10 Kundl, A-6250
English: France SANDOZ 49, avenue Georges Pompidou 92300 Levallois-Perret France
Danish: 49, avenue Georges Pompidou 92300 Levallois-Perret France
English: Poland STADA Arzneimittel AG Stadastrasse 2-18
Danish: STADA Arzneimittel AG Stadastrasse 2-18
English: Quinta da Fonte, Rua Vitor Câmara, 2 - Edifício D.
Danish: Quinta da Fonte, Rua Vitor Câmara, 2 - Edifício D. Amélia, Piso 1, Ala B
English: B-Vilvoorde
Danish: B-Vilvoorde Belgium
English: Sweden Sandoz A/S, , Edvard Thomsens Vej 14
Danish: Sandoz A/S, , Edvard Thomsens Vej 14
English: Belgium Pharmaceuticals Works Pharma SA
Danish: Pharmaceuticals Works Pharma SA
English: Latvia Sandoz d.d., Verovškova 57, SI-1000 Ljubljana,
Danish: Sandoz d.d., Verovškova 57, SI-1000 Ljubljana, Slovenia
English: Romania Pharmaceutical Works Polpharma SA,
Danish: Pharmaceutical Works Polpharma SA,
English: France EG LABO - Laboratoires EuroGenerics "Le Quintet" - bâtiment A 12, rue Danjou
Danish: EG LABO - Laboratoires EuroGenerics "Le Quintet" - bâtiment A 12, rue Danjou 92517 Boulogne Billancourt Cedex
English: Finland ratiopharm GmbH Graf-Arco-Strasse 3
Danish: Finland ratiopharm GmbH Graf-Arco-Strasse 3 Ulm 89079
English: Estonia Pharmaceutical Works Polpharma S.A.
Danish: Pharmaceutical Works Polpharma S.A.
English: Latvia Teva Pharma B.V., Computerweg 10, 3542DR Utrecht, The Netherlands
Danish: Teva Pharma B.V., Computerweg 10, 3542DR Utrecht, The Netherlands
English: Estonia Sandoz d.d.
Danish: Sandoz d.d.
English: Germany Aliud Pharma GmbH Gottlieb-Daimler-Str. 19
Danish: Aliud Pharma GmbH Gottlieb-Daimler-Str. 19 D-89150 Laichingen Germany
English: Norway Sandoz A/S, Edvard Thomsens Vej 14, 2300 København S,
Danish: Edvard Thomsens Vej 14, 2300 København S,
English: Teva UK Limited, Brampton Road, Hampden Park, Eastbourne, East Sussex BN22 9AG United Kingdom
Danish: Storbritannien Teva UK Limited, Brampton Road,
English: Finland Sandoz A/S Edvard Thomsens Vej 14 Copenhagen S 2300 Denmark
Danish: Edvard Thomsens Vej 14 Copenhagen S 2300 Denmark
English: Germany ratiopharm GmbH Graf-Arco-Str. 3
Danish: Tyskland ratiopharm GmbH Graf-Arco-Str. 3 D-89079 Ulm Germany
English: Denmark Sandoz A/S, Edvard Thomsens Vej 14, DK-2300 Copenhagen S, Denmark
Danish: Edvard Thomsens Vej 14, DK-2300 Copenhagen S, Denmark
English: SI-1000 Ljubljana Slovenia
Danish: Verovskova 57 SI-1000 Ljubljana Slovenia
English: Pelplinska Street,
Danish: Hampden Park,
English: Lithuania Pharmaceutical Works POLPHARMA S.A., 19 Pelplinska Street, Starogard Gdanski 83-200 Poland
Danish: Pharmaceutical Works POLPHARMA S.A., 19 Pelplinska Street, Starogard Gdanski 83-200 Poland
English: 19, Peplinska Street Starogar Gdanski
Danish: Pharmaceutical Works Polpharma S.A 19, Peplinska Street Starogar Gdanski
English: Latvia Pharmaceutical Works POLPHARMA SA, 19 Pelplińska Street, 83-200 Starogard Gdański, Poland
Danish: Pharmaceutical Works POLPHARMA SA, 19 Pelplińska Street, 83-200 Starogard Gdański, Poland
English: Estonia Teva Pharma B.V. Computerweg 10
Danish: Teva Pharma B.V.
English: Poland Pharmaceutical Works POLPHARMA SA 19, Pelplińska Street 83-200 Starogard Gdański Poland
Danish: Pharmaceutical Works POLPHARMA SA 19, Pelplińska Street 83-200 Starogard Gdański Poland
English: Finland Stada Arzneimittel AG Stadastrasse 2 - 18
Danish: Stada Arzneimittel AG Stadastrasse 2 - 18 Bad Vilbel 61118
English: The European Commission granted a marketing authorisation valid throughout the European Union for Urorec on 29 January 2010.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Urorec den 29. januar 2010.
English: This is a summary of the European public assessment report (EPAR) for Urorec.
Danish: Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Urorec.
English: The full EPAR for Urorec can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Urorec findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: A risk management plan has been developed to ensure that Urorec is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Urorec anvendes så sikkert som muligt.
English: Other information about Urorec
Danish: Andre oplysninger om Urorec
English: The effects of Urorec were first tested in experimental models before being studied in humans.
Danish: Virkningerne af Urorec blev først afprøvet i forsøgsmodeller, inden de blev undersøgt hos mennesker.
English: In addition, the company that makes Urorec will ensure that eye surgeons are provided with information on IFIS in all Member States where the medicine will be marketed.
Danish: Desuden skal den virksomhed, der fremstiller Urorec, sikre, at øjenkirurger informeres om IFIS i alle de medlemsstater, hvor lægemidlet bliver markedsført.
English: What measures are being taken to ensure the safe and effective use of Urorec?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Urorec?
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Urorec.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om, hvordan Urorec skal anvendes.
English: In the two studies where Urorec was compared only with placebo, the IPSS was around 21 points at the start of the study.
Danish: I de to undersøgelser, hvor Urorec udelukkende blev sammenlignet med placebo, lå IPSS på ca. 21 point ved undersøgelsens start.
English: For more information about treatment with Urorec, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Urorec, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Urorec is a medicine that contains the active substance silodosin.
Danish: Urorec er et lægemiddel, der indeholder det aktive stof silodosin.
English: Urorec was more effective than placebo and as effective as tamsulosin at reducing symptoms of BPH.
Danish: Urorec var mere effektivt end placebo og lige så effektivt som tamsulosin til at mindske symptomerne på BPH.
English: Urorec is not recommended for patients with severe kidney problems.
Danish: Urorec anbefales ikke til patienter med svært nedsat nyrefunktion.
English: The most common side effect with Urorec (seen in more than 1 patient in 10) is a reduction in the amount of semen released during ejaculation.
Danish: Den hyppigste bivirkning ved Urorec (som optræder hos flere end 1 ud af 10 patienter) er en reduktion i mængden af sæd, som frigøres ved ejakulation.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Urorec, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og på indlægssedlen for Urorec, herunder passende forholdsregler, som patienter og sundhedspersonale bør følge.
English: Urorec has been compared with placebo (a dummy treatment) in three main studies involving over 1,800 men with BPH.
Danish: Urorec blev sammenlignet med placebo (en virkningsløs behandling) i tre hovedundersøgelser, der omfattede over 1 800 mænd med BPH.
English: In the third study, IPSS was around 19 points before treatment, falling by 7.0 points in the men who took Urorec after 12 weeks, 6.7 points in the men who took tamsulosin and 4.7 points in the men who took placebo.
Danish: I den tredje undersøgelse lå IPSS på ca. 19 point inden behandlingen, hvorefter den efter 12 uger faldt med 7,0 point hos de mænd, der tog Urorec, med 6,7 point hos de mænd, der tog tamsulosin, og med 4,7 point hos de mænd, der tog placebo.
English: What is the risk associated with Urorec?
Danish: Hvilken risiko er der forbundet med Urorec?