FrancophonIA/ELRC3.0 huggingface dataset:
English: Oral administration of zaleplon to rats for 104 consecutive weeks at dosage levels up to 20 mg/kg/day did not result in compoundrelated tumorigenicity.
Danish: Oral indgivelse af zaleplon til rotter i 104 på hinanden følgende uger i doser op til 20 mg/kg/dag resulterede ikke i tumorgenicitet relateret til stoffet.
English: Overdose of benzodiazepine or benzodiazepine-like agents is usually manifested by degrees of central nervous system depression ranging from drowsiness to coma.
Danish: Overdosis med benzodiazepiner eller benzodiazepin-lignende midler manifesterer sig almindeligvis ved grader af beroligelse af centralnervesystemet lige fra døsighed til koma.
English: Do not store above 30ºC.
Danish: Må ikke opbevares ved temperaturer over 300C.
English: SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS
Danish: EVENTUELLE SÆRLIGE FORHOLDSREGLER VED BORTSKAFFELSE AF UBRUGTE LÆGEMIDLER ELLER AFFALD FRA SÅDANNE
English: • severe breathing or chest problems
Danish: • Hvis De har alvorlige vejrtræknings- eller brystproblemer
English: Hypersensitivity to the active substance or to any of the excipients Severe hepatic impairment
Danish: Overfølsomhed overfor den aktive substans eller nogle af tilsætningsstofferne Alvorlig nedsat leverfunktion
English: Although animal studies have shown no teratogenic effects or embryotoxic effects, insufficient clinical data are available on Zerene to assess its safety during pregnancy and breastfeeding.
Danish: Skønt dyrestudier ikke har vist nogen teratogene eller embryotoksiske virkninger, findes der ikke tilstrækkelige kliniske data vedrørende Zerene til vurdering af dets sikkerhed under graviditet og amning.
English: Uncommon (≥1/1,000 to <1/100) Rare (≥1/10,000 to <1/1,000) Very rare (<1/10,000) not known (cannot be estimated from the available data)
Danish: Meget sjælden ( 1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data)
English: Co-administration of Zerene with a single 800 mg dose of erythromycin, a strong, selective CYP3A4 inhibitor, produced a 34% increase in zaleplon's plasma concentrations.
Danish: Samtidig indgivelse af Zerene og en 800 mg enkeltdosis erythromycin, en kraftigt selektiv CYP3A4 inhibitor gav en beskeden stigning på 34% i plasmakoncentrationen af zaleplon.
English: INFORMATION IN BRAILLE Zerene 10 mg
Danish: INFORMATION I BRAILLE-SKRIFT Zerene 10 mg
English: If you stop taking Zerene
Danish: Hvis De holder op med at tage Zerene:
English: If you forget to take Zerene
Danish: Hvis De glemmer at tage Zerene:
English: HOW TO TAKE ZERENE
Danish: SÅDAN SKAL DE TAGE ZERENE
English: INFORMATION IN BRAILLE Zerene 5 mg
Danish: INFORMATION I BRAILLE-SKRIFT Zerene 5 mg
English: • severe kidney or liver problems
Danish: • Hvis De har alvorlig nyre- eller leverproblemer
English: Take special care with Zerene
Danish: Vær ekstra forsigtig med at tage Zerene:
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON, TEXT FOR ZERENE 10 MG - PACK SIZES 7, 10 AND 14 CAPSULES
Danish: OPLYSNINGER DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE ZERENE 10 MG KAPSLER - PAKNINGSSTØRRELSE 7, 10 OG 14 KAPSLER
English: A. MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE Navn og adresse på fremstilleren ansvarlig for batchfrigivelse MEDA Manufacturing GmbH
English: Side effects that may occur commonly: drowsiness; memory difficulties; sensations like tingling, e.g. in the extremities (paraesthesia); painful menstruation.
Danish: Bivirkninger der almindeligvis kan forekomme: døsighed, hukommelsesbesvær, fornemmelser som snurren, f.eks. i arme og ben (paræstesi), smertefuld menstruation.
English: Co-administration of Zerene with medicinal products known to influence CYP3A4 is expected to result in changes in zaleplon's plasma concentrations.
Danish: Samtidig indgivelse af Zerene og medicin, som vides at påvirke CYP3A4, forventes at resultere i ændringer i plasmakoncentrationen af zaleplon (se 4.5).
English: There are different doses for people who are 65 or older, and those who have mild to moderate liver problems:
Danish: Der er forskellige doser for mennesker, der er 65 år eller ældre, og dem der har milde til moderate leverproblemer: 65 år eller ældre: tag en 5 mg kapsel Milde til moderate leverproblemer: tag en 5 mg kapsel
English: Do not take Zerene if you have
Danish: Tag ikke Zerene:
English: Zerene 5 mg hard capsules, which contain an intensely dark blue powder, have a light brown cap, with gold imprint “W”, and white body, with gold imprint “5 mg”.
Danish: Zerene 5 mg hårde kapsler, som indeholder et stærkt mørkeblåt pulver, har en lysbrun kapseltop med guldtryk ”W” og en hvid kapselunderdel med guldtryk ”5 mg”.
English: CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON
Danish: • BETINGELSER ELLER BEGRÆNSNINGER PÅLAGT INDEHAVEREN AF
English: Tell your doctor if you are breast-feeding.
Danish: Fortæl Deres læge, hvis De ammer.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON, TEXT FOR ZERENE 5 MG - PACK SIZES 7, 10 AND 14 CAPSULES
Danish: OPLYSNINGER DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE ZERENE 5 MG - PAKNINGSSTØRELSE 7, 10 OG 14 KAPSLER
English: In mild cases, symptoms include drowsiness, mental confusion, and lethargy, in more serious cases, symptoms may include ataxia, hypotonia, hypotension, respiratory depression, rarely coma and very rarely death.
Danish: I mere alvorlige tilfælde kan symptomerne omfatte ataksi, hypotoni, hypotension, nedsættelse af åndedrættet, i sjældne tilfælde koma og i meget sjældne tilfælde død.
English: Zerene should not be taken at these times because there are not enough clinical data available to assess its safety during pregnancy.
Danish: Zerene bør ikke tages i disse situationer, fordi der ikke er tilstrækkelige kliniske data til rådighed til at bedømme sikkerheden ved Zerene under graviditet.
English: Zerene 10 mg hard capsules, which contain an intensely dark blue powder, have a white cap, with pink imprint “W”, and white body, with pink imprint “10 mg”.
Danish: Zerene 10 mg hårde kapsler, som indeholder et stærkt mørkeblåt pulver, har en hvid kapseltop med lysrødt tryk ”W” og hvid kapselunderdel med lysrødt tryk ”10 mg”.
English: Frequency not known:
Danish: Hyppighed ikke fastslået
English: Printing inks on the shell contain the following (gold ink S-13050): shellac, lecithin, simethicone, yellow iron oxide (E172).
Danish: Trykfarverne på kapslen indeholder følgende (guldfarve S-13050): shellack, lecithin, simethicone, gul jernoxid (E172).
English: Zerene has been designed, so that if the contents of the capsule are dissolved in liquid, the liquid will change colour and become cloudy.
Danish: Zerene er fremstillet således, at hvis kapslens indhold opløses i væske, vil væsken skifte farve og blive uklar.
English: Uncommon side effects include: dizziness; weakness; reduced coordination of movements; unsteadiness and/or falls (ataxia); decreased concentration; apathy; restlessness; depression; agitation; irritability; confusion, abnormal thinking and behaviour (extroversion that seems out of character, decreased inhibition, aggressiveness, rages, delusion, depersonalisation, psychosis); nightmares; hallucinations; double vision or other sight problems; increased sensitivity to noise (hyperacusis); smell disorder (parosmia); speech disorders, including slurred speech; numbness, e.g. in the extremities (hypoaesthesia); nausea; decreased appetite; increased sensitivity to light (sunlight, UV light); feeling vaguely ill (malaise).
Danish: Ikke almindelige bivirkninger inkluderer: svimmelhed, svaghed, nedsat koordination af bevægelser, vaklen og/eller fald (ataksi), nedsat koncentration, sløvhed, hvileløshed, depression, ophidselse, irritabilitet, forvirring, unormal tænkning og opførsel (udadvendthed som ikke synes at passe til personen, nedsat hæmning, aggressivitet, raseri, vrangforestillinger, depersonalisation, psykose), mareridt, hallucinationer, dobbeltsyn eller andre synsproblemer, øget følsomhed over for støj (hyperakusis), lugtforstyrrelser (parosmi), taleforstyrrelser, inkl.
English: 7 hard capsules 10 hard capsules 14 hard capsules
Danish: 14 hårde kapsler
English: MEDA Manufacturing GmbH Neurather Ring 1
Danish: MEDA Manufacturing GmbH
English: MARKETING AUTHORISATION NUMBER(S) EU/1/99/099/004 7 capsules
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/99/099/004 - 7 kapsler
English: Read the package leaflet before use.
Danish: ANVENDELSESMÅDE OG INDGIVELSESVEJ(E) Læs indlægssedlen inden brug.
English: Printing inks on the shell contain the following (pink ink SW-1105): shellac, titanium dioxide (E171), ammonium hydroxide, red iron oxide (E172), yellow iron oxide (E172).
Danish: Trykfarverne på kapslen indeholder følgende (lyserød farve SW-1105): shellack, titandioxid (E171), ammoniumhydroxid, rød jernoxid (E172), gul jernoxid (E172).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/99/099/001 7 capsules
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/99/099/001 - 7 kapsler
English: Capsules have an opaque white and opaque light brown hard shell with gold band, “W” and the strength “5 mg”.
Danish: Kapslernes skal er hård, uigennemsigtig hvid og lys brun med guldbånd, mærket “W” og styrken “5 mg”.
English: Zerene has been shown to preserve sleep stages in controlled studies that measured the percentage of sleep time spent in each sleep stage.
Danish: I kontrollerede studier, hvor man målte procenten af søvn i hvert søvnstadie, er Zerene påvist at opretholde søvnstadierne.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 5 MG CAPSULE BLISTERS
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ BLISTERKORT ELLER BLISTERSTRIPS ZERENE 5 MG KAPSLER
English: The active substance in each Zerene hard capsule is zaleplon 5 mg.
Danish: Det aktive indholdsstof i hver Zerene hårde kapsel er 5 mg zaleplon.
English: The active substance in each Zerene hard capsule is zaleplon 10 mg.
Danish: Det aktive indholdsstof i hver Zerene hårde kapsel er 10 mg zaleplon.
English: Zerene should not be taken at this time because there is not enough clinical data available to assess its safety during breast-feeding.
Danish: Zerene bør ikke tages i disse situationer, fordi der ikke er tilstrækkelige kliniske data til rådighed til at bedømme sikkerheden ved Zerene under amning.
English: − Keep this leaflet.
Danish: Tag æsken med.
English: Medicinal product subject to medical prescription.
Danish: MARKEDSFØRINGSTILLADELSEN VEDRØRENDE UDLEVERING OG BRUG Lægemidlet er receptpligtigt.
English: Excipients: Lactose monohydrate 49 mg.
Danish: Hjælpestof: Lactosemonohydrat 49 mg En liste over alle hjælpestoffer er anført under pkt.
English: − This medicine has been prescribed for you.
Danish: - Lægen har ordineret Zerene til Dem personligt.
English: Capsules have an opaque white hard shell with pink band, “W” and the strength “10 mg”.
Danish: Kapslernes skal er hård, uigennemsigtig hvid med lyserødt bånd, mærket “W” og styrken “10 mg”.
English: Excipient: Lactose monohydrate 54 mg.
Danish: Hjælpestof: Lactosemonohydrat 54 mg En liste over alle hjælpestoffer er anført under pkt.
English: The other ingredients are microcrystalline cellulose, pregelatinised starch, silicon dioxide, sodium lauryl sulphate, magnesium stearate, lactose monohydrate, indigo carmine (E132), titanium dioxide (E171).
Danish: De øvrige indholdsstoffer er mikrokrystallinsk cellulose, prægelatineret stivelse, siliciumdioxid, natriumlaurylsulfat, magnesiumstearat, monohydratlaktose, indigo karminrød (E132), titandioxid (E171).
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 10 MG CAPSULE BLISTERS
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ BLISTERKORT OG BLISTERSTRIPS ZERENE 10 MG KAPSLER
English: If you take more Zerene than you should
Danish: Hvis De har taget for meget Zerene
English: Microcrystalline cellulose, pregelatinised starch, silicon dioxide, sodium lauryl sulphate, magnesium stearate, lactose monohydrate, indigo carmine (E132), titanium dioxide (E171).
Danish: Kapselindhold Mikrokrystallinsk cellulose, prægelatineret stivelse, siliciumdioxid, natriumlaurylsulfat, magnesiumstearat, laktose monohydrat, indigo karminrød (E132), titandioxid (E171).
English: What Zerene looks like and contents of the pack
Danish: Udseende og pakningsstørrelser
English: − If you have any further questions, ask your doctor or pharmacist.
Danish: Spørg Deres læge eller apotek, hvis De har yderligere spørgsmål.
English: − If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
Danish: - Tal med lægen eller apoteket, hvis en bivirkning bliver værre, eller De får bivirkninger, som ikke er nævnt her.
English: Ingredients of the capsule shell: gelatin, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172), black iron oxide (E172), sodium lauryl sulphate and silicon dioxide.
Danish: Kapslens skal indeholder: gelatine, titandioxid (E171), rød jernoxid (E172), gul jernoxid (E172), sort jernoxid (E172), natriumlaurylsulfat og ciliciumdioxid.
English: Severe renal impairment
Danish: Alvorlig nedsat nyrefunktion
English: Capsule shell gelatin, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172), black iron oxide (E172), sodium lauryl sulphate, silicon dioxide.
Danish: kapselskal: gelatine, titandioxid (E171), rød jernoxid (E172), gul jernoxid (E172), sort jernoxid (E172), natriumlaurylsulfat, siliciumdioxid.
English: • Reactions like restlessness, agitation, irritability, aggressiveness, abnormal thinking, delusion, rages, nightmares, depersonalisation, hallucinations, psychoses, inappropriate behaviour, extroversion that seems out of character and other behavioural effects have been reported following use of any medicines belonging to the sleep inducing group, including Zerene.
Danish: • Reaktioner som rastløshed, ophidselse, irritabilitet, aggressivitet, unormal tænkning, vrangforestillinger, raserianfald, mareridt, uvirkeligheds- eller fremmedfølelse, hallucinationer, tvangstanker (psykoser), upassende adfærd, udadvendthed som ikke synes at passe til personen og andre uønskede adfærdsmæssige reaktioner kan forekomme ved brug af søvnfremkaldende medicin inklusiv Zerene.
English: Excretion
Danish: Udskillelse
English: Zerene 5 mg hard capsules zaleplon
Danish: Zerene 5 mg, hårde kapsler (zaleplon)
English: Capsule shell gelatin, titanium dioxide (E171), sodium lauryl sulphate, silicon dioxide.
Danish: Kapselskal: gelatine, titandioxid (E171), natriumlaurylsulfat, siliciumdioxid.
English: NAME OF THE MEDICINAL PRODUCT Zerene 5 mg hard capsules zaleplon
Danish: LÆGEMIDLETS NAVN Zerene 5 mg, hårde kapsler zaleplon
English: Zerene 10 mg hard capsules zaleplon
Danish: Zerene 10 mg, hårde kapsler (zaleplon)
English: NAME OF THE MEDICINAL PRODUCT Zerene 10 mg hard capsules zaleplon
Danish: LÆGEMIDLETS NAVN Zerene 10 mg, hårde kapsler zaleplon
English: NAME OF THE MEDICINAL PRODUCT Zerene 5 mg hard capsules
Danish: LÆGEMIDLETS NAVN Zerene 5 mg, hårde kapsler.
English: NAME OF THE MEDICINAL PRODUCT Zerene 10 mg hard capsules
Danish: LÆGEMIDLETS NAVN Zerene 10 mg, hårde kapsler.
English: Ingredients of the capsule shell: gelatin, titanium dioxide (E171), sodium lauryl sulphate and silicon dioxide.
Danish: Kapslens skal indeholder: gelatine, titandioxid (E171), natriumlaurylsulfat og ciliciumdioxid.
English: Elderly patients may be sensitive to the effects of hypnotics; therefore, 5 mg is the recommended dose of Zerene.
Danish: Ældre patienter kan være følsomme overfor hypnotikas virkning.
English: EU/1/99/099/004-006
Danish: EU/1/99/099/006 - 14 kapsler
English: Adverse Reactions
Danish: Bivirkninger
English: Elderly
Danish: Zerene
English: • If you are taking any medicines belonging to the sleep inducing group, including Zerene, there is a possibility that you may become dependent on them.
Danish: • Hvis De tager nogen form for sovemedicin, inkl.
English: EU/1/99/099/002 10 capsules EU/1/99/099/003 14 capsules
Danish: EU/1/99/099/002 - 10 kapsler
English: EU/1/99/099/005 10 capsules EU/1/99/099/006 14 capsules
Danish: EU/1/99/099/005 - 10 kapsler
English: EU/1/99/099/001-003
Danish: NUMMER I EU-REGISTRET FOR LÆGEMIDLER EU/1/99/099/001-003
English: • the recommended methods for reconstitution of the product prior to implantation
Danish: • De anbefalede metoder til rekonstituering af produktet inden implantation
English: These descriptive texts are included in the product information.
Danish: Produktinformationen indeholder sådan beskrivende tekst.
English: • the preparation of the selected paraspinal site where the intended implantation will occur
Danish: • Forberedelse af det valgte paraspinale område, hvor implantationen skal udføres
English: - Information about: Hypersensitivity and antibody formation Embryo-foetotoxicity and the need for women with childbearing potential to use effective contraception for 2 years following implant
Danish: - Information om: Overfølsomhed og antistofdannelse Embryo-fostertoksicitet og nødvendigheden af, at kvinder i den fødedygtige alder anvender et effektivt præventionsmiddel i mindst 2 år efter implantationen
English: • the recommended manner of placement of the material together with some comments on the importance of local haemostasis
Danish: • Den anbefalede metode for placering af materialet plus kommentarer om vigtigheden af lokal hæmostase
English: • the methods for soft tissue closure around the implant.
Danish: • Metoder til lukning af bløddelsvæv omkring implantatet.
English: The National Competent Authorities shall agree the details of an education programme for surgeons with the MAH, who must implement such programme nationally to ensure that:
Danish: Indehaveren af markedsføringstilladelsen skal sammen med nationale ansvarlige myndigheder godkende detaljerne i et uddannelsesprogram for kirurger og implementere et sådant program nationalt for at sikre at:
English: 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:
Danish: Medlemslandene skal sørge for, at alle de betingelser eller begrænsninger, som er beskrevet nedenfor med hensyn til en sikker og virkningsfuld anvendelse af lægemidlet, bliver implementeret:
English: In addition, prior to use, surgeons intending to use Opgenra should receive a Training DVD containing animated images of an operation on a patient and including the following information: - Product description - Placement in sterile field - Wound opening (soft and hard tissues) - Reconstitution of product - Implant field preparation (haemostasis) - Administration (implantation) - Containment of implanted materials (soft tissues) - Instrumentation - Wound closure (drainage) - Follow-up measures
Danish: - Produktbeskrivelse - Placering i sterilt område - Åbning af sår (blødt og hårdt væv) - Rekonstituering af produktet - Forberedelse af implantationssted (hæmostase) - Administration (implantation) - Fastholdelse af det implanterede materiale (blødt væv) - Instrumentering - Sårlukning (drænage) - Opfølgningsforanstaltninger
English: Prior to use of the product, surgeons should be provided with educational material containing: - a copy of the SPC - a detailed description of:
Danish: Kirurgerne skal modtage uddannelsesmateriale med nedenstående indhold, inden produktet anvendes: - En kopi af produktresumeet - En detaljeret beskrivelse af:
English: CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
Danish: BETINGELSER ELLER BEGRÆNSNINGER, SOM SKAL IMPLEMENTERES AF MEDLEMSLANDENE, MED HENSYN TIL EN SIKKER OG VIRKNINGSFULD ANVENDELSE AF LÆGEMIDLET
English: • the risks of ectopic bone formation interaction with bone void fillers that the product should only be used once - details of the post marketing surveillance studies including information on how to enroll patients
Danish: • Ricisi for ektopisk knogledannelse Interaktion med fyldningsmaterialer til knogledefekter At produktet kun må anvendes én gang.
English: This summary was last updated in 10-2007.
Danish: Dette sammendrag blev sidst ajourført i 10-2007.
English: The marketing authorisation was renewed on 26 February 2004.
Danish: Markedsføringstilladelsen blev fornyet den 26. februar 2004.
English: Medicinal product no longer authorise©EMEA 2007
Danish: Lægemidlet er ikke længere autoriseret til sal©EMEA 2007
English: The first infusion is given in the 24 hours before transplantation.
Danish: Den første infusion gives 24 timer før transplantationen.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Zenapax to Roche Registration Limited on 26 February 1999.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Zenapax til Roche Registration Limited den 26. februar 1999.
English: It contains the active substance daclizumab (5 mg/ml).
Danish: Det indeholder det aktive stof daclizumab (5 mg/ml).
English: These antibodies can develop following blood transfusion, pregnancy or previous organ transplantation.
Danish: Disse antistoffer kan udvikle sig som følge af en blodtransfusion, graviditet eller en tidligere organtransplantation.
English: The recommended dose for adults and children is 1 mg per kilogram body weight, diluted in 50 ml sterile saline solution and given over 15 minutes.
Danish: Den anbefalede dosis til voksne og børn er 1 mg pr. kilo legemsvægt, som opløses i 50 ml steril saltvandsopløsning og indgives i løbet af 15 minutter.
English: It is used in patients who do not have high levels of antibodies against ‘foreign' cells from other people.
Danish: Det anvendes til patienter, som ikke har et højt niveau af antistoffer mod "fremmede" celler fra andre mennesker.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) ZENAPAX EPAR summary for the public
Danish: EUROPÆISK OFFENTLIG VURDERINGSRAPPORT (EPAR) ZENAPAX EPAR - sammendrag for offentligheden
English: A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and bind to a specific structure (called an antigen) that is found on certain cells in the body.
Danish: Et monoklonalt antistof er et antistof (en type protein), som er blevet udviklet til at genkende og binde sig til en bestemt struktur (kaldet et antigen), som findes i visse af kroppens celler.
English: Other information about Zenapax:
Danish: Andre oplysninger om Zenapax:
English: Zenapax has been studied in two main studies involving a total of 535 adults undergoing kidney transplant.
Danish: Zenapax blev undersøgt i to hovedundersøgelser, som omfattede i alt 535 voksne, der fik en nyretransplantation.
English: The most common side effects (seen in more than 1 patient in 10) were insomnia (difficulty sleeping), tremor (shaking), headache, hypertension (high blood pressure), dyspnoea (difficulty breathing), constipation, diarrhoea, vomiting, nausea (feeling sick), dyspepsia (heartburn), musculoskeletal pain (pain in the muscles and joints), oedema (swelling), impaired healing and post-traumatic pain (pain after surgery).
Danish: De mest almindelige bivirkninger (set hos over 1 ud af 10 patienter) var søvnløshed, rysten, hovedpine, forhøjet blodtryk, vejrtrækningsbesvær, forstoppelse, diarré, opkastning, kvalme, halsbrand, smerter i led og muskler, hævelse, helingsvanskeligheder og post-traumatiske smerter (smerter efter kirurgisk indgreb).
English: The Committee recommended that Zenapax be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Zenapax.
English: In this study, Zenapax was added to the children's existing immunosuppressive medicines.
Danish: I denne undersøgelse blev Zenapax kombineret med børnenes eksisterende immunosuppressive lægemidler.
English: It is used together with other immunosuppressive (anti-rejection) medicines including ciclosporin and corticosteroids.
Danish: Det anvendes sammen med andre immunosuppressive (afstødningshindrende) lægemidler, herunder ciclosporin og kortikosteroider.
English: These cells are involved in recognising ‘foreign' cells and rejecting transplanted organs.
Danish: Disse blodlegemer er med til at genkende "fremmede" celler og afstøde transplanterede organer.