FrancophonIA/ELRC3.0 huggingface dataset:
English: However, data on elderly patients exposed to the maximum dose (120mg per day) are limited and thus, caution is recommended when treating this population.
Danish: Idet data for ældre patienter udsat for den maksimale dosis (120 mg dagligt) er begrænset, anbefales det, at der udvises forsigtighed, når denne befolkningsgruppe behandles.
English: Use in children and adolescents under 18 years of age Xeristar should not be used in the treatment of children and adolescents under the age of 18 years.
Danish: Xeristar bør ikke bruges til behandling af børn og unge under 18 år.
English: Major Depressive Disorder and Generalised Anxiety Disorder: Depression is associated with an increased risk of suicidal thoughts, self harm and suicide (suicide-related events).
Danish: Moderate til svære depressioner og generaliseret angst: Depression er forbundet med en øget risiko for selvmordstanker, at forvolde skade på sig selv og selvmord (selvmordsrelaterede handlinger), Risikoen forbliver, indtil der er signifikant remission.
English: Feeling abnormal Feeling cold Thirst
Danish: Føler sig kold Tørst
English: Night sweats Urticaria
Danish: Nattesved Urticaria
English: Duloxetine is detected in breast milk, and steady-state concentrations in breast milk are about one-fourth those in plasma.
Danish: Steady-state koncentrationerne i human mælk er ca. en fjerdedel af plasmakoncentrationerne.
English: The following are reasons why Xeristar may not be suitable for you.
Danish: I følgende situationer kan du muligvis ikke anvende Xeristar.
English: In clinical trials adverse events seen on abrupt treatment discontinuation occurred in approximately 45% of patients treated with Xeristar and 23% of patients taking placebo.
Danish: I kliniske studier er der observeret utilsigtede hændelser ved pludselig afbrydelse af behandlingen hos ca. 45 % og 23 % af patienterne behandlet med hhv. Xeristar og placebo.
English: Caution is advised if Xeristar is co-administered with medicinal products that are predominantly metabolised by CYP2D6 (risperidone, tricyclic antidepressants [TCAs] such as nortriptyline, amitriptyline, and imipramine) particularly if they have a narrow therapeutic index (such as flecainide, propafenone and metoprolol).
Danish: Det anbefales at udvise forsigtighed ved administration af Xeristar sammen med præparater, som hovedsageligt metaboliseres via CYP2D6 (risperidon, tricycliske antidepressiva [TCA'er] såsom nortriptylin, amitriptylin og imipramin), specielt hvis disse præparater har et snævert terapeutisk indeks (som f.eks. flecainid, propafenon og metoprolol).
English: Xeristar with food, drink and alcohol
Danish: Brug af Xeristar sammen med mad, drikke og alkohol Xeristar kan tages med og uden mad.
English: The efficacy and safety of Xeristar 30-120 mg once daily in elderly patients with generalised anxiety disorder was similar to that seen in studies of younger adult patients.
Danish: Virkningen og sikkerheden af Xeristar 30-120 mg en gang dagligt hos ældre patienter med generaliseret angst svarede til virkningen og sikkerheden observeret i studier med yngre voksne patienter.
English: In the extension phase of these studies, which lasted up to 52 weeks, there was an increase in HbA1c in both the duloxetine and routine care groups, but the mean increase was 0.3% greater in the duloxetinetreated group.
Danish: I denne periode var der stigninger i HbA1C både i duloxetin- og standardbehandlingsgrupperne, men den gennemsnitlige stigning var 0,3 % større i gruppen behandlet med duloxetin.
English: Xeristar 30 mg is available in packs of 7 and 28 capsules.
Danish: Xeristar 30 mg findes i blisterpakninger med 7 og 28 kapsler.
English: Each capsule may contain up to 111 mg sucrose.
Danish: Hjælpestof, som behandleren skal være opmærksom på Hver kapsel kan indeholde op til 111 mg saccharose.
English: Multipack: 500 (25 packs of 20) hard gastro-resistant capsules Multipack: 100 (5 packs of 20) hard gastro-resistant capsules
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Multipakning: 500 (25 pakninger a 20) hårde enterokapsler Multipakning: 100 (5 pakninger a 20) hårde enterokapsler
English: These medicines increase the risk of side effects; if you get any unusual symptom taking any of these medicines together with Xeristar, you should see your doctor.
Danish: Hvis du får usædvanlige symptomer, når du tager et af disse lægemidler sammen med Xeristar, skal du kontakte din læge.
English: EU/1/04/297/005 EU/1/04/297/006 EU/1/04/297/007 EU/1/04/297/008
Danish: EU/1/04/297/001 EU/1/04/297/002 EU/1/04/297/003 EU/1/04/297/004 EU/1/04/297/005 EU/1/04/297/006 EU/1/04/297/007 EU/1/04/297/008
English: Xeristar contains sucrose
Danish: Xeristar indeholder saccharose
English: Xeristar should not be used in combination with fluvoxamine, ciprofloxacin or enoxacin (i.e. potent CYP1A2 inhibitors) since the combination results in elevated plasma concentrations of duloxetine (see section 4.5).
Danish: Xeristar må ikke anvendes sammen med potente CYP1A2 hæmmere, som fluvoxamin, ciprofloxacin og enoxacin, idet kombinationen resulterer i forhøjet plasmakoncentration af duloxetin (se pkt.
English: Xeristar 30 mg Xeristar 30 mg is available in packs of 7 and 28 hard gastro-resistant capsules.
Danish: Xeristar 30 mg Xeristar 30 mg findes i pakninger med 7 og 28 hårde enterokapsler.
English: The initiation of treatment with Xeristar is contraindicated in patients with uncontrolled hypertension that could expose patients to a potential risk of hypertensive crisis (see sections 4.4 and 4.8).
Danish: For patienter med ukontrolleret hypertension, er der kontraindikation for opstart af behandling med Xeristar, da det kan udsætte patienterne for en potentiel risiko for hypertensive kriser (se pkt.
English: Capsule shell: gelatin, sodium lauryl sulfate, titanium dioxide (E171), indigo carmine (E132), yellow iron oxide (E172) (60 mg only) and edible green ink (30 mg) or edible white ink (60 mg).
Danish: 2 for yderligere information om saccharose) Kapsellåg og -bund: Gelatine, natriumlaurilsulfat, titandioxid (E171), indigotin (E132), gul jernoxid (E172) (kun i 60 mg) og Edible Green Ink (30 mg) eller Edible White Ink (60 mg).
English: Hyponatraemia has been reported when administering Xeristar, including cases with serum sodium lower than 110 mmol/l.
Danish: Hyponatriæmi, herunder tilfælde med serum-natriumværdier under 110 mmol/l, er blevet rapporteret efter indgivelse af Xeristar.
English: Xeristar must not be used in patients with severe renal impairment (creatinine clearance <30 ml/min; see section 4.3).
Danish: Xeristar må ikke bruges til patienter med svært nedsat nyrefunktion (kreatininclearance <30 ml/min, se pkt.
English: • “Serotonin syndrome” (a rare reaction which may cause feelings of great happiness, drowsiness, clumsiness, restlessness, feeling of being drunk, fever, sweating or rigid muscles), fits
Danish: • ”Serotoninsyndrom” (en sjælden bivirkning, der kan forårsage unormal opstemthed, døsighed, klodsethed, rastløshed, en følelse af at være beruset, feber, tendens til at svede eller muskelstivhed), krampeanfald
English: Elevated liver enzymes (ALT, AST, alkaline phosphatase)
Danish: Forhøjede leverenzymer (ALAT, ASAT, basisk fosfatase) Akut leverskade
English: Xeristar 30 mg Gelatin
Danish: Xeristar 30 mg Gelatine
English: Xeristar is a hard gastro-resistant capsule.
Danish: Xeristar er en hård enterokapsel.
English: Caution is advisable if Xeristar is used concomitantly with serotonergic agents like SSRIs, SNRIs, tricyclic antidepressants like clomipramine or amitriptyline, MAOIs like moclobemide or linezolid, St John's wort (Hypericum perforatum) or triptans, tramadol, pethidine and tryptophan (see section 4.4).
Danish: Det anbefales at udvise forsigtighed, hvis Xeristar anvendes sammen med serotonerge lægemidler som SSRI-præparater, SNRI-præparater, tricykliske antidepressiva (f.eks. clomipramin eller amitriptylin), MAOI'er som moclobemid eller linezolid, perikon (Hypericum perforatum) eller triptaner, tramadol, pethidin og tryptophan (se afsnit 4.4).
English: After an oral dose the apparent plasma clearance of duloxetine ranges from 33 to 261 l/hr (mean 101 l/hr).
Danish: Efter en oral dosis ligger den tilsyneladende plasma-clearance for duloxetin på 33-261 l/t.
English: The use of Xeristar while breastfeeding is not recommended.
Danish: Det anbefales ikke at bruge Xeristar, mens du ammer.
English: Do not stop taking Xeristar, or change your dose, without talking to your doctor.
Danish: Du må kun stoppe behandlingen eller ændre dosis efter aftale med lægen.
English: • Tell your doctor if you are breast-feeding.
Danish: Fortæl din læge, hvis du ammer.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
Danish: Fortæl det altid til lægen eller apotekspersonalet, hvis du bruger anden medicin eller har gjort det for nylig.
English: If your doctor has prescribed Xeristar for a patient under 18 and you want to discuss this, please go back to your doctor.
Danish: Du bedes henvende dig til din læge, hvis din læge har udskrevet Xeristar til en patient under 18 år, og du gerne vil diskutere dette.
English: Do not take more than the daily amount of Xeristar that has been prescribed for you in one day.
Danish: Du må ikke tage mere Xeristar pr. dag, end lægen har ordineret.
English: Adverse reactions may be more common during concomitant use of Xeristar and herbal preparations containing St John's wort (Hypericum perforatum).
Danish: Bivirkninger kan forekomme hyppigere ved samtidig brug af Xeristar og naturlægemidler samt kosttilskud indeholdende perikon (hypericum perforatum).
English: Overall, Xeristar's efficacy has been demonstrated at daily doses between 60 and 120 mg in a total of five out of seven randomised, double-blind, placebo-controlled, fixed dose acute studies in adult outpatients with major depressive disorder.
Danish: Som helhed er der vist effekt af Xeristar ved en daglig fast dosering mellem 60 og 120 mg i ialt fem ud af syv randomiserede dobbeltblinde, placebokontrollerede studier på voksne akutte ambulante patienter med moderate til svære depressioner.
English: How to take Xeristar
Danish: Sådan skal du tage Xeristar
English: Xeristar contains sucrose.
Danish: Xeristar indeholder saccharose.
English: The efficacy of Xeristar at the recommended dose of 60 mg once a day was demonstrated in three out of three randomised, double-blind, placebo-controlled, fixed dose acute studies in adult outpatients with major depressive disorder.
Danish: Effekten af Xeristar er vist med den anbefalede faste dosis på 60 mg én gang dagligt i tre ud af tre randomiserede dobbeltblinde, placebokontrollerede studier på voksne akutte ambulante patienter med moderate til svære depressioner.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIPACK- INNER CARTON FOR 60 MG HARD GASTRO-RESISTANT CAPSULES (without blue box)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE MULTIPAKNING - INDRE KARTON TIL 60 MG HÅRDE ENTEROKAPSLER (uden blå boks)
English: Dosages above 60 mg once daily, up to a maximum dose of 120 mg per day have been evaluated from a safety perspective in clinical trials.
Danish: Doseringer over 60 mg en gang dagligt op til maksimaldosis på 120 mg om dagen er evalueret ud fra et sikkerhedsmæssigt perspektiv i kliniske studier.
English: Talk to your doctor before you take Xeristar if you: - are taking other medicines to treat depression (see ‘Other medicines and Xeristar') - are taking St. John's Wort, a herbal treatment (Hypericum perforatum) - have kidney disease - have had seizures (fits) - have had mania - suffer from bipolar disorder - have eye problems, such as certain kinds of glaucoma (increased pressure in the eye) - have a history of bleeding disorders (tendency to develop bruises), especially if you are pregnant (see ‘Pregnancy and breast-feeding‘) - are at risk of low sodium levels (for example if you are taking diuretics, especially if you are elderly) - are currently being treated with another medicine which may cause liver damage - are taking other medicines containing duloxetine (see ‘Other medicines and Xeristar')
Danish: Xeristar”) - tager et naturlægemiddel, som indeholder perikon (Hypericum perforatum) - har en nyresygdom - tidligere har haft krampeanfald - tidligere har haft mani - lider af bipolar sygdom - har øjenproblemer såsom visse typer af grøn stær (glaukom - forøget tryk i øjet) - tidligere har lidt af blødningsforstyrrelser (tendens til blå mærker), især hvis du er gravid (se
English: Dizziness, sensory disturbances (including paraesthesia or electric shock-like sensations, particularly in the head), sleep disturbances (including insomnia and intense dreams), fatigue, somnolence, agitation or anxiety, nausea and/or vomiting, tremor, headache, myalgia, irritability, diarrhoea, hyperhydrosis and vertigo are the most commonly reported reactions.
Danish: De almindeligste bivirkninger er svimmelhed, sensoriske forstyrrelser (inklusive paræstesier og følelsen af elektriske stød, især i hovedet), søvnforstyrrelser (inklusive søvnløshed og intense drømme), træthed, søvnighed, opstemthed eller angst, kvalme og/eller opkastning, rysten, hovedpine, myalgi, irritabilitet, diaré, hyperhidrosis og vertigo.
English: After an intravenous dose the plasma clearance of duloxetine ranges from 22 l/hr to 46 l/hr (mean of 36 l/hr).
Danish: Efter en intravenøs dosis ligger duloxetins plasma-clearance på 22-46 l/t.
English: Method of administration For oral use.
Danish: Administration Til oral brug.
English: Eli Lilly Slovakia s.r.o.
Danish: Slovenská republika Eli Lilly Slovakia s.r.o.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIPACK-OUTER CARTON FOR 60 MG HARD GASTRO-RESISTANT CAPSULES (with blue box)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE MULTIPAKNING - YDRE KARTON TIL 60 MG HÅRDE ENTEROKAPSLER (med blå boks)
English: Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
Danish: Xeristar hårde enterokapsler indeholder saccharose og bør derfor ikke anvendes til patienter med arvelig fructoseintolerans, glucose/galactosemalabsorption eller invertase/isomaltasemangel.
English: EU/1/04/297/002 (28 hard gastro-resistant capsules) EU/1/04/297/003 (84 hard gastro-resistant capsules) EU/1/04/297/004 (98 hard gastro-resistant capsules) EU/1/04/297/005 (56 hard gastro-resistant capsules)
Danish: EU/1/04/297/002 (28 hårde enterokapsler) EU/1/04/297/003 (84 hårde enterokapsler) EU/1/04/297004 (98 hårde enterokapsler) EU/1/04/297/005 (56 hårde enterokapsler)
English: What you need to know before you take Xeristar DO NOT take Xeristar if you:
Danish: Det skal du vide, før du begynder at tage Xeristar Sådan skal du tage Xeristar Bivirkninger
English: Concomitant use of Xeristar with nonselective, irreversible monoamine oxidase inhibitors (MAOIs) is contraindicated (see section 4.5).
Danish: Xeristar må ikke anvendes sammen med ikke-selektive, irreversible monoaminoxidasehæmmere (MAO-hæmmere) (se pkt.
English: EU/1/04/297/007 (500 hard gastro-resistant capsules) (25 packs of 20) EU/1/04/297/008 (100 hard gastro-resistant capsules) (5 packs of 20)
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/04/296/007 (500 hårde enterokapsler) (25 pakninger a 20) EU/1/04/296/008 (100 hårde enterokapsler) (5 pakninger a 20)
English: Each capsule may contain up to 56 mg sucrose.
Danish: Hjælpestof, som behandleren skal være opmærksom på Hver kapsel kan indeholde op til 56 mg saccharose Xeristar 60 mg
English: Τηλ: +357 22 715000
Danish: Phadisco Ltd Τηλ: +357 22 715000
English: Suicidal
Danish: Selvmords-tanker
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTONS FOR 60 MG HARD GASTRO-RESISTANT CAPSULES
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE KARTON TIL 60 MG HÅRDE ENTEROKAPSLER
English: Clinical response rates in patients experiencing somnolence were 60% on duloxetine and 30% on placebo.
Danish: Hos patienter, som havde oplevet somnolens, blev der målt klinisk respons hos 60 % af de duloxetinbehandlede patienterne og 30 % af de placebobehandlede patienter.
English: Stomatitis Haematochezia Breath odour Microscopic colitis9
Danish: Mikroskopisk kolitis9
English: Opaque green body, imprinted with ‘60 mg' and an opaque blue cap, imprinted with ‘9542'.
Danish: Mat grøn kapselbund med påskriften "60 mg" og mat blå kapseltop med påskriften "9542".
English: Feeling hot Gait disturbance
Danish: Kuldegysninger Føler sig syg Varmefølelse Gangforstyrrelse
English: Xeristar 30 mg hard gastro-resistant capsules.
Danish: Xeristar 30 mg hårde enterokapsler.
English: Opaque white body, imprinted with ‘30 mg' and an opaque blue cap, imprinted with ‘9543'.
Danish: Mat hvid kapselbund med påskriften "30 mg" og mat blå kapseltop med påskriften "9543".
English: Dermatitis contact Cold sweat Photo-sensitivity reactions
Danish: Kontaktdermatitis Koldsved Lysfølsomhedsreaktioner Øget tendens til at få blå mærker
English: Xeristar 60 mg hard gastro-resistant capsules.
Danish: Xeristar 60 mg hårde enterokapsler.
English: EU/1/04/297/001 (28 hard gastro-resistant capsules) EU/1/04/297/006 (7 hard gastro-resistant capsules)
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/04/297/001 (28 hårde enterokapsler) EU/1/04/297/006 (7 hårde enterokapsler)
English: Rare
Danish: Megetalmindelig
English: Xeristar 30 mg hard gastro-resistant capsules Xeristar 60 mg hard gastro-resistant capsules
Danish: Xeristar 30 mg hårde enterokapsler Xeristar 60 mg hårde enterokapsler duloxetin (som hydrochlorid)
English: Constipation Diarrhoea Abdominal pain Vomiting Dyspepsia Flatulence
Danish: Obstipation Diarré Abdominal
English: The effect of Xeristar 60 mg once a day in elderly depressed patients (≥65 years) was specifically examined in a study that showed a statistically significant difference in the reduction of the HAMD17 score for duloxetine-treated patients compared to placebo.
Danish: I et studie med ældre depressive patienter (≥ 65 år), som viste en statistisk signifikant forskel i reduktionen i HAMD17-scoren for duloxetinbehandlede patienter sammenlignet med placebo, blev effekten af Xeristar 60 mg en gang dagligt særligt undersøgt.
English: Sleep disorder Bruxism Disorientation Apathy behaviour5,7 Mania
Danish: Søvnforstyrrelser Tænderskæren Desorientering Apati
English: − are taking or have taken within the last 14 days, another medicine known as a monoamine oxidase inhibitor (MAOI) (see ‘Other medicines and Xeristar')
Danish: (monoaminoxidasehæmmer) (se ”Brug af anden medicin sammen med Xeristar”)
English: Each capsule contains 30 or 60 mg of duloxetine (as hydrochloride).
Danish: Hver kapsel indeholder 30 eller 60 mg duloxetin som hydrochlorid.
English: In a relapse prevention study, patients responding to 12-weeks of acute treatment with open-label Xeristar 60 mg once daily were randomised to either Xeristar 60 mg once daily or placebo for a further 6-months.
Danish: I et studie med forebyggelse af tilbagefald, hvor patienterne blev randomiserede til enten Xeristar 60 mg eller placebo, efter 12-ugers akut behandling med open-label Xeristar 60 mg én gang dagligt viste Xeristar 60 mg én gang dagligt sig statistisk signifikant bedre end placebo (p=0,004) på den primære parameter, som var forebyggelsen af depressive tilbagefald målt som tid til tilbagefald.
English: Xeristar 60 mg hard gastro-resistant capsules Duloxetine
Danish: LÆGEMIDLETS NAVN Xeristar 60 mg hårde enterokapsler Duloxetin
English: Xeristar must not be used in patients with liver disease resulting in hepatic impairment (see sections 4.3 and 5.2).
Danish: Nedsat leverfunktion Xeristar må ikke gives til patienter med nedsat leverfunktion på grund af leversygdom (se pkt.
English: Xeristar 30 mg hard gastro-resistant capsules Duloxetine
Danish: LÆGEMIDLETS NAVN Xeristar 30 mg hårde enterokapsler Duloxetin
English: If you take more Xeristar than you should
Danish: Hvis du har taget for meget Xeristar
English: Postpartum haemorrhage6
Danish: Postpartum blødning6
English: Gastrointestinal haemorrhage7 Gastroenteritis Eructation Gastritis Dysphagia
Danish: Gastrointestinal blødning7
English: In an open label long-term uncontrolled study, the pain reduction in patients responding to 8-weeks of acute treatment of Xeristar 60 mg once daily was maintained for a further 6-months as measured by change on the Brief Pain Inventory (BPI) 24-hour average pain item.
Danish: Hos de patienter, som responderede på 8-ugers akut behandling med 60 mg Xeristar en gang dagligt i et open-label, langtids, ukontrolleret studie, holdt smertereduktionen i yderligere 6 måneder.
English: Weight increased to match other children and adolescents of their age and sex after 6 months of treatment.
Danish: Efter 6 måneders behandling var vægten steget så den svarede til deres jævnaldrendes af samme køn.
English: These symptoms may include floppy muscles, trembling, jitteriness, not feeding properly,
Danish: Symptomerne omfatter slappe muskler, skælven, spjætteri, spisebesvær, vejrtrækningsproblemer og krampeanfald.
English: In both studies, Xeristar 60 mg once daily and 60 mg twice daily significantly reduced pain compared with placebo.
Danish: Xeristar blev givet i to forskellige dagsdoser: 60 mg én gang dagligt og 60 mg to gange dagligt.
English: − are taking other medicines containing duloxetine (see ‘Other medicines and Xeristar') Talk to your doctor if you have high blood pressure or heart disease.
Danish: Kontakt lægen før du tager Xeristar, hvis du: - tager anden medicin til behandling af depression (se ”Brug af anden medicin sammen med
English: Acute liver injury
Danish: Stomatitis Hæmatokeksi Dårlig ånde
English: Content (concentration) Package size
Danish: Emballage Indhold (koncentration) Pakningsstørrelse
English: EU Number Invented name Strength Pharmaceutical form Route of administration Packaging
Danish: Særnavn Styrke Lægemiddelform Indgivelsesvej
English: Ampoule (glass) 3 ml
Danish: Ampul (glas) 3 ml
English: 3 ampoules
Danish: 3 ampuller
English: 3 vials l t o r
Danish: r l
English: It is available in three forms:
Danish: Den findes i tre former:
English: This summary was last updated in 01-2016.
Danish: Dette sammendrag blev sidst ajourført i 01-2016.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Rotarix on 21 February 2006.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Rotarix den 21. februar 2006.
English: The full EPAR for Rotarix can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Rotarix findes på agenturets websted: 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 Rotarix.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Rotarix.
English: Rotarix should never be injected under any circumstances.
Danish: Rotarix må aldrig under nogen omstændigheder injiceres.
English: The virus is alive, but it has been weakened so that it does not cause the disease, which makes it suitable for use in a vaccine.
Danish: Dette virus er levende, men er blevet svækket, så det ikke forårsager sygdommen, hvilket gør det egnet til brug i en vaccine.
English: Rotarix is given according to official recommendations.
Danish: Rotarix gives i overensstemmelse med de officielle anbefalinger.
English: A risk management plan has been developed to ensure that Rotarix is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Rotarix anvendes så sikkert som muligt.
English: Other information about Rotarix:
Danish: Andre oplysninger om Rotarix:
English: Ideally, both doses should be given before the baby is aged 16 weeks and they must be given by the time the baby is 24 weeks old.
Danish: Ideelt bør begge doser gives, inden barnet bliver 16 uger, og skal være givet, når barnet bliver 24 uger.
English: Rotarix can be given at the same time as other vaccines.
Danish: Rotarix kan gives samtidigt med andre vacciner.