FrancophonIA/ELRC3.0 huggingface dataset:
English: Excipients: Sodium chloride, disodium hydrogen phosphate, potassium dihydrogen phosphate, potassium chloride, water for injections
Danish: Hjælpestoffer: Natriumchlorid, dinatriumhydrogenphosphat, kaliumdihydrogenphosphat, kaliumchlorid,
English: NAME OF THE MEDICINAL PRODUCT Pumarix suspension and emulsion for emulsion for injection.
Danish: Indlægsseddel: Information til brugeren Pumarix suspension og emulsion til injektionsvæske, emulsion.
English: Split influenza virus inactivated, containing antigen equivalent to: A/Indonesia/05/2005 (H5N1) like strain used (PR8-IBCDC-RG2)
Danish: Split influenzavirus, inaktiveret, indeholdende antigen svarende til: A/Indonesia/05/2005 (H5N1)-lignende stamme (PR8-IBCDC-RG2)
English: Half dose N=42
Danish: half dosis n = 42
English: In another clinical study (Q-Pan-H5N1-001), the anti-haemagglutinin (anti-HA) antibody responses in subjects aged 18-64 years were as follows:
Danish: I et andet klinisk studie (Q-Pan-H5N1-001) var anti-hæmagglutinin (anti-HA)-antistofresponset hos
English: Forty-two days after the booster dose, the seroprotection rate against
Danish: 42 dage efter boosterdosen var seroprotektionsraten mod begge stammer 98,4 %.
English: Redness
Danish: Amning
English: AS03 adjuvant composed of squalene (10.69 milligrams), DL-α-tocopherol (11.86 milligrams) and
Danish: AS03-adjuvans bestående af squalen (10,69 mg), DL-α-tocopherol (11,86 mg) og polysorbat 80
English: This is as long as medical treatment is available straight away, in case you have an allergic reaction.
Danish: - I tilfælde af en pandemi kan det være hensigtsmæssig at blive vaccineret alligevel, under forudsætning af at medicinsk behandling er umiddelbart tilgængelig i tilfælde af en overfølsomhedsreaktion.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Antigen suspension for Pumarix
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E)
English: • Generalised skin reactions including urticaria (hives)
Danish: • Vaskulitis (betændelse i blodkarrerne, som kan forårsage hududslæt, ledsmerter og nyreproblemer)
English: Mix with adjuvant emulsion before use
Danish: Suspensionen skal sammenblandes med adjuvans, emulsion, før administration.
English: In other clinical studies where children 6 months to 17 years received a similar vaccine containing A/Indonesia/05/2005, increases in the frequency of some side effects (including injection site pain, redness and fever) were seen after the second dose in children aged less than 6 years.
Danish: Stigninger i hyppigheden af visse bivirkninger (herunder smerte ved injektionsstedet, rødme og feber) hos børn under 6 år blev set i andre kliniske studier, hvor børn fra 6 måneder til 17 år fik en anden pandemisk influenzavaccine indeholdende A/Indonesia/05/2005.
English: C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING
Danish: B. BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING
English: The vial containing the adjuvant should be maintained in upside down position to facilitate the withdrawal of the full content.
Danish: For at lette udtagningen af al adjuvans i hætteglasset skal hætteglasset holdes med
English: The following information is intended for healthcare professionals only:
Danish: Følgende oplysninger er tiltænkt sundhedspersonale: Pumarix består af to hætteglas:
English: • two packs containing 25 vials of 2.5 ml emulsion (adjuvant) Marketing Authorisation Holder and Manufacturer GlaxoSmithKline Biologicals s.a.
Danish: • to pakker med 25 hætteglas a 2,5 ml emulsion (adjuvans)
English: Induration Pain
Danish: Emulsionen har
English: If you get any side effects, talk to your doctor.
Danish: Hvis nogle af disse bivirkninger opstår, skal du straks fortælle det til din læge eller
English: • Being sick, stomach pain, acid indigestion
Danish: • Ømme muskler, ledsmerter
English: Common: may affect up to 1 in 10 people • Redness and swelling where the injection was given
Danish: • Rødme og hævelse hvor indsprøjtningen blev givet
English: Read the package leaflet before use
Danish: Intramuskulær anvendelse Omrystes før brug Læs indlægssedlen inden brug.
English: Breast-feeding
Danish: • Svedtendens
English: This can cause bleeding or bruising.
Danish: • Lavt blodpladetal, som kan medføre blødninger eller blå mærker
English: In other clinical studies where children 6 months to 17 years received another pandemic influenza vaccine (H5N1 A/Indonesia/05/2005 manufactured in Dresden, Germany), increases in the frequency of some side effects (including injection site pain, redness and fever) were seen after the second dose
Danish: Stigninger i hyppigheden af visse bivirkninger (herunder smerte ved administrationsstedet, rødme og feber) efter anden dosis til børn under 6 år blev observeret i andre kliniske studier, hvor børn fra 6 måneder til 17 år fik en anden pandemisk influenzavaccine (H5N1 A/Indonesien/05/2005 fremstillet i
English: 2booster seroconversion rate: proportion of subjects who were either seronegative at pre-booster and have a protective post-vaccination titre of ≥1:40, or who were seropositive at pre-booster and have a 4
Danish: 1 seroprotektionsraten: andelen af forsøgspersoner med hæmagglutinationshæmningstiter (HI) ≥ 1:40; 2 booster-serokonverteringsraten: andelen af forsøgspersoner, som enten var seronegative før boostervaccination og opnår en beskyttende post-vaccinationstiter på ≥ 1:40, eller som var seropositive før boostervaccination og opnår en firdobbelt stigning af titer;
English: Caution is needed when administering this vaccine to persons with a known hypersensitivity (other than anaphylactic reaction) to the active substance, to any of the excipients listed in section 6.1, to thiomersal and to residues (egg and chicken protein, ovalbumin, formaldehyde and sodium
Danish: Der skal udvises forsigtighed, når vaccinen gives til personer med kendt overfølsomhed (ud over anafylaktisk reaktion) over for det aktive stof eller over for et eller flere af hjælpestofferne anført i pkt.
English: If you have any further questions on the use of this vaccine, ask your doctor or nurse.
Danish: Hvis nogle af disse bivirkninger opstår efter vaccination med Pumarix, skal du straks fortælle det til din læge eller sygeplejerske:
English: After two priming doses
Danish: Den anden dosis vil blive
English: The mixed vaccine is a whitish
Danish: Hvis den sammenblandede vaccine ser anderledes ud, skal den
English: GlaxoSmithKline S.p.A. Tel:+ 39 04 59 21 81 11
Danish: GlaxoSmithKline A.E.B.E Tηλ: + 30 210 68 82 100
English: “How Pumarix is
Danish: Du kan godt få Pumarix, men
English: • Pain in the chest
Danish: • Hovedpine
English: Gastrointestinal disorders
Danish: Nervesystemet
English: Oral use Oral use Oral use Oral use Oral use
Danish: Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse
English: Blister (PVC/PVdC/alu) Blister (PVC/PVdC/alu) Blister (PVC/PVdC/alu) Blister (PVC/PVdC/alu) Tablet container (HDPE)
Danish: Blister (PVC/PVdC/alu) Blister (PVC/PVdC/alu) Blister (PVC/PVdC/alu) Blister PVC/PVdC/alu) Tabletbeholder (HDPE)
English: 28 tablets 30 tablets 84 tablets 100 tablets 60 tablets
Danish: 28 tabletter 30 tabletter 84 tabletter 100 tabletter 60 tabletter
English: Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet
Danish: Filmovertrukket tablet Filmovertrukket tablet Filmovertrukket tablet Filmovertrukket tablet Filmovertrukket tablet
English: Lamivudine Teva Lamivudine Teva Lamivudine Teva Lamivudine Teva Lamivudine Teva
Danish: Lamivudin Teva Lamivudin Teva Lamivudin Teva Lamivudin Teva Lamivudin Teva
English: Pack size
Danish: Pakningsstø rrelse
English: Name
Danish: (Særnavn) Navn Styrke
English: Elderly patients may also be more susceptible to drug-associated effects on the QT interval.
Danish: Ældre patienter kan også være mere følsomme over for lægemiddelrelaterede effekter på QTintervallet.
English: Therefore it is important to consider this diagnosis in patients who develop serious diarrhoea during or after the use of moxifloxacin.
Danish: Det er derfor vigtigt at overveje denne diagnose hos patienter, som udvikler alvorlig diaré under eller efter moxifloxacinbehandlingen.
English: The following should be reflected as appropriate (the new text is shown in bold and underlined and text to be deleted is shown strikethrough):
Danish: Følgende skal angives, hvor det er passende (den nye tekst er vist som understreget, og tekst der skal slettes er vist som gennemstreget i versionen med markerede ændringer):
English: [Invented name] is an antibiotic belonging to the quinolone family.
Danish: [Lægemidlets (sær)navn] er et antibiotikum tilhørende quinolonfamilien.
English: Furthermore, appropriate infection control measures should be undertaken to reduce the risk of transmission.
Danish: Ydermere bør tilstrækkelige tiltag for at kontrollere infektionen iværksættes for at undgå overførsel.
English: Common ≥ 1/100 to < 1/10
Danish: Almindelig (≥1/100 til <1/10)
English: As women tend to have a longer baseline QTc interval compared with men, they may be more sensitive to QTcprolonging medications.
Danish: Idet kvinder har tendens til at have længere udgangsværdi for QTc-intervallet sammenlignet med mænd, kan de være mere følsomme over for QTc-forlængende lægemidler.
English: If AAD or AAC is suspected or confirmed, ongoing treatment with antibacterial agents, including moxifloxacin, should be discontinued and adequate therapeutic measures should be initiated immediately.
Danish: Hvis AAD eller AAC mistænkes eller bekræftes, skal igangværende behandling med antibiotika, inklusive moxifloxacin, afbrydes og passende terapeutiske tiltag omgående iværksættes.
English: Possible side effects) contact your doctor immediately before you continue the treatment.
Danish: Bivirkninger), skal De omgående kontakte Deres læge, inden De fortsætter behandlingen.
English: Drugs inhibiting peristalsis are contraindicated in patients who develop serious diarrhoea.
Danish: Lægemidler, som hæmmer peristaltikken, er kontraindiceret hos patienter, som udvikler alvorlig diaré.
English: Before taking [Invented name] 400 mg film-coated tablets - [Invented name] can change your heart's ECG, especially if you are female, or if you are elderly.
Danish: Før De tager [Lægemidlets (sær)navn] 400 mg filmovertrukne tabletter [Lægemidlets (sær)navn] kan ændre hjertets EKG, særligt hvis De er en kvinde eller en ældre person.
English: Rare ≥ 1/10,000 to
Danish: Sjælden (≥1/10.000 til
English: Patients should be advised to contact their doctor immediately prior to continuing treatment if skin and/or mucosal reactions occur.
Danish: Patienten bør rådes til øjeblikkeligt at kontakte sin læge, før behandlingen fortsættes, hvis hudog/eller slimhindereaktioner opstår.
English: [Invented name] should only be used to treat these infections when usual antibiotics cannot be used or have not worked.
Danish: [Lægemidlets (sær)navn] må kun anvendes til behandling af disse infektioner, hvis almindelige antibiotika ikke kan anvendes eller ikke har haft nogen virkning.
English: Ventricular tachyarrhythmias Syncope (i.e., acute and short lasting loss of consciousness) Hypertension Hypotension
Danish: Ventrikulære takyarytmier Synkope (f.eks. akut og kortvarende tab af bevidsthed) Hypertension Hypotension
English: - Moxifloxacin should be used with caution in patients with myasthenia gravis because the symptoms can be exacerbated.
Danish: - Moxifloxacin bør anvendes med forsigtighed hos patienter med myasthenia gravis, idet symptomerne kan forværres.
English: Moxifloxacin should be used with caution in patients with ongoing proarrhythmic conditions (especially women and elderly patients), such as acute myocardial ischaemia or QT prolongation as this may lead to an increased risk for ventricular arrhythmias (incl.
Danish: Moxifloxacin bør anvendes med forsigtighed hos patienter med igangværende proarytmiske tilstande såsom (især kvinder og ældre patienter) akut myokardieiskæmi eller QT-forlængelse, da dette kan medføre en øget risiko for ventrikulære arytmier (inkl.
English: If you are currently taking any medicine that decrease your blood potassium levels, consult your doctor before taking [Invented name].
Danish: Hvis De tager anden medicin, der nedsætter blodets kaliumniveau, skal De kontakte lægen, inden De begynder at tage [Lægemidlets (sær)navn].
English: - If you suffer from myasthenia gravis taking [Invented name] may worsen the symptoms of your disease.
Danish: Hvis De lider af myasthenia gravis, kan behandling med [Lægemidlets (sær)navn] forværre symptomerne for sygdommen.
English: torsade de pointes) and cardiac arrest (see also section 4.3)..
Danish: torsade de pointes) og hjertestop (se også pkt.
English: [Invented name] contains moxifloxacin as the active ingredient which belongs to a group of antibiotics called fluoroquinolones.
Danish: Det aktive indholdsstof i [Lægemidlets (sær)navn] er moxifloxacin, der tilhører en gruppe antibiotika kaldet fluoroquinoloner.
English: If you think you are affected consult your doctor immediately.
Danish: Hvis De tror, at De er ramt af sygdommen, kontakt da Deres læge.
English: ANNEX III AMENDMENTS TO THE SUMMARY OF PRODUCT CHARACTERISTICS AND PACKAGE LEAFLET
Danish: BILAG III ÆNDRINGER TIL PRODUKTRESUME OG INDLÆGSSEDDEL
English: Uncommon ≥ 1/1,000 to
Danish: Ikke almindelig (≥1/1.000 til
English: There have been very rare cases of the following side effects reported following treatment with other fluoroquinolones, which might possibly also occur during treatment with moxifloxacin: transient loss of vision, hypernatraemia, hypercalcaemia, haemolysis, rhabdomyolysis, photosensitivity reactions (see section 4.4).
Danish: Der har været meget sjældne tilfælde af følgende bivirkninger efter behandling med andre fluoroquinoloner, som måske også vil kunne forekomme under behandling med moxifloxacin: Forbigående tab af synet, hypernatriæmi, hypercalciæmi, hæmolyse, rabdomyolyse, fotosensitive reaktioner (se pkt.
English: - Antibiotic associated diarrhoea (AAD) and antibiotic-associated colitis (AAC), including pseudomembranous colitis and Clostridium difficile-associated diarrhoea, has been reported in association with the use of broad spectrum antibiotics including moxifloxacin and may range in severity from mild diarrhoea to fatal colitis.
Danish: - Antibiotikarelateret diaré (AAD) og antibiotikarelateret kolitis (AAC), herunder pseudomembranøs kolitis og Clostridium difficile associeret diaré, er blevet indberettet i forbindelse med brugen af bredspektrede antibiotika, inklusive moxifloxacin.
English: Moxifloxacin should be used to treat adequately diagnosed ABS and AECB only when it is considered inappropriate to use antibacterial agents that are commonly recommended for the initial treatment of these infections or when these have failed to resolve the infection.
Danish: Moxifloxacin bør kun anvendes til at behandle ABS og AEBC, der er blevet tilfredsstillende diagnosticeret, hvis behandling med de former for antibiotika, der normalt anbefales som førstevalg ved disse infektioner, ikke kan bruges, eller i de tilfælde, hvor disse antibiotika ikke har virket mod infektionen.
English: [Invented name] is used in patients of 18 years and older for treating the following bacterial infections when caused by bacteria against which moxifloxacin is active: infection of the sinuses, sudden worsening of long term inflammation of the airways or infection of the lungs (pneumonia) acquired outside the hospital (except severe cases).
Danish: [Lægemidlets (sær)navn] anvendes til behandling af voksne over 18 år med følgende bakterielle infektioner, der er forårsaget af bakterier, som moxifloxacin virker mod: bihulebetændelse, pludselig forværring af kronisk bronkitis eller lungebetændelse, som man har fået uden for hospitalet (med undtagelse af alvorlige tilfælde).
English: Bullous skin reactions like Stevens-Johnson syndrome or toxic epidermal necrolysis (potentially lifethreatening, see section 4.4)
Danish: Bulløse hudreaktioner som Stevens-Johnson's Syndrom eller toksisk epidermal nekrolyse (potentielt livstruende, se pkt.
English: AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTIONS OF THE PACKAGE LEAFLET FOR MOXIFLOXACIN CONTAINING MEDICINAL PRODUCTS
Danish: ÆNDRINGER DER SKAL INKLUDERES I DE RELEVANTE AFSNIT AF INDLÆGSSEDLEN FOR LÆGEMIDLER INDEHOLDENE MOXIFLOXACIN
English: 4.7 Effects on ability to drive and use machines (…) However, fluoroquinolones including moxifloxacin may result in an impairment of the patient's ability to drive or operate machinery due to CNS reactions (e.g. dizziness, see section 4.8) or acute and short lasting loss of consciousness (syncope, see section 4.8).
Danish: 4.7 Virkning på evnen til at føre motorkøretøj eller betjene maskiner (…) Fluroquinoloner inklusive moxifloxacin kan dog resultere i en forringelse af patientens evne til at køre eller betjene maskiner pga. CNS reaktioner (f.eks. svimmelhed, se pkt.
English: AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTIONS OF THE SUMMARY OF PRODUCT CHARACTERISTICS FOR MOXIFLOXACIN CONTAINING MEDICINAL PRODUCTS
Danish: ÆNDRINGER DER SKAL INKLUDERES I DE RELEVANTE AFSNIT AF PRODUKTRESUMEET FOR LÆGEMIDLER INDEHOLDENE MOXIFLOXACIN
English: Rupture of tendon, inflammation of joints, muscle rigidity, worsening of the symptoms of myasthenia gravis
Danish: Meget sjælden: seneforstrækning, betændelse i led, muskelstivhed, forværring af symptomer for myasthenia gravis.
English: - Community acquired pneumonia, except severe cases Moxifloxacin should be used only when it is considered inappropriate to use antibacterial agents that are commonly recommended for the initial treatment of this infection.
Danish: - Ikke hospitalserhvervet lungebetændelse, med undtagelse af svære tilfælde Moxifloxacin bør kun anvendes, hvis behandling med de former for antibiotika, der normalt anbefales som førstevalg ved denne infektion, ikke kan bruges.
English: - [Invented name] may cause a rapid and severe inflammation of the liver which could lead to life-threatening liver failure (including fatal cases, see section 4.
Danish: [Lægemidlets (sær)navn] kan give hurtig og alvorlig betændelse i leveren, som kan udvikle sig til livstruende leversvigt (herunder tilfælde af dødsfald, se pkt.
English: Driving and using machines [Invented name] may make you feel dizzy or light-headed or you might faint for a short period.
Danish: Trafik- og arbejdssikkerhed [Lægemidlets (sær)navn] kan medføre svimmelhed eller uklarhed, eller De kan besvime i kortere perioder.
English: - Cases of bullous skin reactions like Stevens-Johnson syndrome or toxic epidermal necrolysis have been reported with moxifloxacin (see section 4.8).
Danish: - Tilfælde af bulløse hudreaktioner såsom Stevens-Johnson syndrom eller toksisk epidermal nekrolyse er blevet indberettet med moxifloxacin (se pkt.
English: - If you develop a skin reaction or blistering and/or peeling of the skin and/or mucosal reactions (see section 4.
Danish: Hvis De får hududslæt eller blistre og/eller afskalling af hud og/eller slimhindebetændelse (se pkt.
English: - Cases of fulminant hepatitis potentially leading to liver failure (including fatal cases) have been reported with moxifloxacin (see section 4.8).
Danish: - Tilfælde af fulminant hepatitis, som potentielt kan føre til leverinsufficiens (herunder tilfælde af dødsfald), er blevet indberettet ved brug af moxifloxacin (se pkt.
English: WHAT [INVENTED NAME] 400 MG FILM-COATED TABLETS ARE AND WHAT THEY ARE USED FOR
Danish: [LÆGEMIDLETS (SÆR)NAVN] 400 MG FILMOVERTRUKNE TABLETTERS VIRKNING OG HVAD DE SKAL BRUGE DET TIL
English: When taking [Invented name] 400 mg film-coated tablets
Danish: Når De tager [Lægemidlets (sær)navn] 400 mg filmovertrukne tabletter
English: HOW TO TAKE [INVENTED NAME] 400 MG FILM-COATED TABLETS -Sudden worsening of chronic bronchitis (acute exacerbation of chronic bronchitis) 5 - 10 days
Danish: 5-10 dage ved pludselig forværring af kronisk bronkitis (akut forværring af kronisk bronkitis).
English: Muscular and Joint System Very rare:
Danish: Muskler og led:
English: [Invented name] works by killing bacteria that cause infections, if they are caused by bacteria that are susceptible to the active ingredient moxifloxacin.
Danish: [Lægemidlets (sær)navn] virker ved at dræbe bakterier, der forårsager infektioner.
English: fatal cases, see section
Danish: Seneruptur (se pkt.
English: Hepatobiliary Disorders
Danish: Arthritis
English: Furthermore, there have been very rare cases of the following side effects reported following treatment with other quinolone antibiotics, which might possibly also occur during treatment with [Invented name]: transient loss of vision, increased blood sodium levels, increased blood calcium levels, increased breakdown of red blood cells, muscle reactions with muscle cell damage, increased sensitivity of the skin to sunlight or UV light.
Danish: Forbigående synstab, forhøjet natriumindhold i blodet, forhøjet calciumindhold i blodet, øget nedbrydning af røde blodlegemer, muskelreaktioner med beskadigelse af muskelceller, øget følsomhed af huden over for sollys og UV-lys.
English: 4.1 Therapeutic indications [Invented name] 400 mg film-coated tablets are indicated for the treatment of the following bacterial infections in patients of 18 years and older (see section 4.4, 4.8 and 5.1): - Acute bacterial sinusitis (ABS) - Acute exacerbations of chronic bronchitis (AECB)
Danish: 4.4, 4.8 og 5.1): - Akut bakteriel sinuitis (ABS) - Akut forværring af kronisk bronkitis (AECB)
English: BEFORE YOU TAKE [INVENTED NAME] 400 MG FILM-COATED TABLETS
Danish: DET SKAL DE VIDE, FØR DE BEGYNDER AT TAGE [LÆGEMIDLETS (SÆR)NAVN] 400 MG FILMOVERTRUKNE TABLETTER
English: Fulminant hepatitis potentially leading to life-threatening liver failure (incl.
Danish: Fulminant hepatitis som potentielt kan føre til livstruende leversvigt (herunder tilfælde af dødsfald, se pkt.
English: Cardiac and Vascular Disorders
Danish: Lever og galdeveje
English: 4.2 Posology and method of administration Duration of administration Acute bacterial sinusitis
Danish: 4.2 Dosering og indgivelsesmåde
English: The European Commission granted a marketing authorisation valid throughout the European Union for Sifrol to Boehringer Ingelheim International GmbH on 14 October 1997.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Sifrol til Boehringer Ingelheim International GmbH den 14. oktober 1997.
English: The full EPAR for Sifrol can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Sifrol findes på agenturets websted under ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: This document is a summary of the European Public Assessment Report (EPAR) for Sifrol.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Sifrol.
English: Sifrol pramipexole
Danish: Sifrol pramipexol
English: Sifrol tablets should be swallowed with water.
Danish: Sifrol-tabletter sluges med vand.
English: Sifrol must be given less often in patients who have problems with their kidneys.
Danish: Sifrol skal gives mindre hyppigt til patienter, som har problemer med deres nyrer.
English: Other information about Sifrol:
Danish: Andre oplysninger om Sifrol:
English: Sifrol is used to treat the symptoms of the following diseases:
Danish: Sifrol anvendes til behandling af symptomerne på følgende sygdomme:
English: Sifrol is used when a specific cause for the disorder cannot be identified.
Danish: Sifrol anvendes, når det ikke er muligt at fastslå en bestemt årsag til sygdommen.
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 Sifrol.
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 anvendelsesbetingelserne for Sifrol.