FrancophonIA/ELRC3.0 huggingface dataset:
English: Unresponsive to stimuli, Loss of consciousness, Neuroleptic malignant syndrome, Diabetic coma, Cerebrovascular accident, Depressed level of consciousness, Cerebral ischemia, Cerebrovascular disorder, Transient ischemic attack, Dysarthria, Disturbance in attention, Balance disorder, Speech disorder, Coordination abnormal, Movement disorder Eye Disorders
Danish: Manglende reaktion over for stimuli, bevidstløshed, malignt neuroleptikasyndrom, diabetisk koma, cerebrovaskulært anfald, bevidsthedssvækkelse, cerebral iskæmi, cerebrovaskulære forstyrrelser, transitorisk iskæmisk attak, dysartri, opmærksomhedsforstyrrelser, balanceforstyrrelser, taleforstyrrelser, unormal koordination, bevægelsesforstyrrelser
English: Parkinsonism includes: increase in saliva secretion or watery mouth, musculoskeletal stiffness, drooling, jerks when bending the limbs, slow, reduced or impaired body movements, no expression on the face, muscle tightness, stiff neck, muscle stiffness, small, shuffling, hurried steps and lack of normal arm movements when walking, persistent blinking in response to tapping of the forehead (an abnormal reflex).
Danish: Parkinsonisme omfatter: Øgning af spytproduktionen, stivhed i musklerne og skelettet, savlen, spjæt når lemmerne bøjes, langsomme, nedsatte eller hæmmede bevægelser, manglende ansigtsudtryk, muskelhårdhed, stivhed i nakken, muskelstivhed, små trippende fodtrin og mangel på normale armbevægelser under gang, vedvarende blinken ved slag (stimulering) af panden (en unormal refleks).
English: Czech
Danish: Tjekkiet
English: Belgium Janssen Cilag N.V. Roderveldlaan 1, 2600 Berchem, Belgium
Danish: Roderveldlaan 1, 2600 Berchem, Belgien
English: GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
Danish: BEGRUNDELSER FOR ÆNDRING AF PRODUKTRESUMÉET, ETIKETTERINGEN OG INDLÆGSSEDLEN
English: - the scope of the referral was the harmonisation of the Summaries of Products Characteristics, labelling and package leaflet,
Danish: - Formålet med indbringelsen var at harmonisere produktresuméer, etikettering og indlægsseddel.
English: • You are diabetic
Danish: • Hvis du har diabetes.
English: Norway:
Danish: Norge:
English: High-Wycombe Buckinghamshire HP 14 4HJ United Kingdom
Danish: Buckinghamshire HP 14 4HJ Storbritannien
English: Injections should alternate between the buttocks.
Danish: Injektionerne bør indgives skiftevis i højre og venstre balle.
English: Perform a onehanded technique by GENTLY pressing the needle protection device against a flat surface.
Danish: Foretag enhåndsteknikken ved at trykke hylsteret LET mod en flad overflade.
English: DO NOT STORE THE VIAL AFTER RECONSTITUTION OR THE SUSPENSION MAY SETTLE.
Danish: HÆTTEGLASSET MÅ IKKE OPBEVARES EFTER REKONSTITUTIONEN, DA SUSPENSIONEN SÅ KAN BUNDFÆLDES.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer Carton (Pack with ALARIS)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Ydre karton (pakning med Alaris)
English: Netherlands:
Danish: Holland:
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer Carton (Pack with 3 needle system)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Ydre karton (pakning med 3-nåls-system)
English: Swab the connection point of the vial access device with preferred antiseptic prior to attaching the syringe to the vial access device.
Danish: Rens samlestedet på hætteglasadgangsudstyret med det foretrukne antiseptikum, før injektionssprøjten sættes på hætteglasadgangsudstyret.
English: Neuroleptic Malignant Syndrome, characterised by hyperthermia, muscle rigidity, autonomic instability, altered consciousness and elevated serum creatine phosphokinase levels has been reported to occur with antipsychotics.
Danish: For antipsykotika er der rapporter om malignt neuroleptikasyndrom, som er karakteriseret ved hypertermi, muskelrigiditet, autonom ustabilitet, ændret bevidsthedsniveau og forhøjet serumkreatinfosfokinase.
English: Flip off the plastic coloured cap from the vial.
Danish: Fjern det farvede plasticlåg fra hætteglasset.
English: • Blood prolactin hormone level increased, liver enzymes increased, decrease in hemoglobin or red blood cell count (anemia), blood sugar increased
Danish: • Stigning i blodets indhold af hormonet prolactin, stigning i leverenzymer, fald i hæmoglobin eller antallet af røde blodlegemer (blodmangel), højt blodsukker.
English: Renal tubular adenomas occurred in male rats treated with RISPERDAL CONSTA at 40 mg/kg/2 weeks.
Danish: Der blev observeret adenomer i nyretubuli hos hanrotter behandlet med RISPERDAL CONSTA ved 40 mg/kg/2 uger.
English: Poland:
Danish: Polen:
English: What RISPERDAL CONSTA looks like and contents of the pack [To be completed nationally]
Danish: RISPERDAL CONSTAS udseende og pakningsstørrelse [Udfyldes nationalt]
English: Invert the vial completely and slowly withdraw the entire contents of the suspension from the vial.
Danish: Vend hætteglasset helt, og træk langsomt suspensionen op fra hætteglasset.
English: Do not administer intravenously (see section 4.4 and section 6.6).
Danish: Må ikke indgives intravenøst (se pkt.
English: Please tell your doctor or pharmacist if you are using or have recently used any other medicines, including medicines obtained without a prescription and herbal medicines.
Danish: Fortæl det altid til lægen eller apoteket, hvis du bruger anden medicin eller har brugt det for nylig.
English: It has been demonstrated that risperidone and 9-hydroxy-risperidone are also excreted in human breast milk in small quantities.
Danish: Det er påvist, at risperidon og 9-hydroxyrisperidon også udskilles i små mængder i human modermælk.
English: The following medicines may increase the effect of risperidone • Quinidine (used for certain types of heart disease)
Danish: Følgende lægemidler kan nedsætte virkningen af risperidon • Rifampicin (et middel til behandling af visse infektioner)
English: Extensive CYP 2D6 metabolisers convert risperidone rapidly into 9-hydroxy-risperidone, whereas poor CYP 2D6 metabolisers convert it much more slowly.
Danish: 9-hydroxyrisperidon, hvorimod personer med en langsom CYP 2D6-funktion omdanner det meget langsommere.
English: Press the syringe tip into the vial access device and twist in a clockwise motion to ensure that the syringe is securely attached to the white luer cap of the vial access device.
Danish: Tryk sprøjtens spids ind i hætteglasadgangsudstyret, og drej med uret for at sikre, at sprøjten sidder godt fast på den hvide luerspids på hætteglasadgangsudstyret.
English: The effectiveness of RISPERDAL CONSTA (25 mg and 50 mg) in the management of the manifestations of psychotic disorders (schizophrenia/schizoaffective disorder) was established in one 12-week, placebo-controlled trial in adult psychotic inpatients and outpatients who met the DSM-IV criteria for schizophrenia.
Danish: Effekten af RISPERDAL CONSTA (25 mg og 50 mg) på håndteringen af manifestationerne af psykotiske forstyrrelser (skizofreni/skizoaffektiv lidelse) blev fastsat i et 12-ugers placebokontrolleret forsøg.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT [To be completed nationally] OTHER Keep prefilled syringe in the outer carton
Danish: INDHOLDSMÆNGDE ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER [Udfyldes nationalt] ANDET Opbevar den fyldte injektionssprøjte i yderkartonen.
English: For risperidone-naive patients, it is recommended to establish tolerability with oral risperidone prior to initiating treatment with RISPERDAL CONSTA (see section 4.2).
Danish: Hos patienter, der ikke tidligere er behandlet med risperidon, anbefales det at fastlægge tolerabiliteten med oral risperidon, inden behandling med RISPERDAL CONSTA påbegyndes (se pkt.
English: • Skin discoloration, skin lesion, skin disorder, thickening of the skin
Danish: • Misfarvning af huden, sår på huden, hudsygdomme, fortykkelse af huden.
English: Urinary incontinence Skin and subcutaneous tissue disorders Common
Danish: Urininkontinens Hud og subkutane væv Almindelig
English: “It has been demonstrated that risperidone and 9-hydroxy-risperidone are also excreted in human breast-milk in small quantities.
Danish: “Det er dokumenteret, at risperidon og 9-hydroxy-risperidon også udskilles i små mængder i human modermælk.
English: Johnson & Johnson D.O.O.
Danish: Bulgarien Johnson & Johnson D.O.O.
English: Galantamine and donepezil do not show a clinically relevant effect on the pharmacokinetics of risperidone and on the active antipsychotic fraction.
Danish: Galantamin og donepezil viser ikke klinisk relevant effekt på risperidons farmakokinetik eller den aktive antipsykotiske fraktion.
English: Johnson & Johnson d.o.o.,
Danish: Slovenien Johnson & Johnson d.o.o.,
English: “Risperdal Consta should not be used in acute exacerbations of schizophrenia without ensuring sufficient antipsychotic coverage with oral risperidone or the previous antipsychotic during the threeweek lag period following the first Risperdal Consta injection.”
Danish: “Risperdal Consta bør ikke anvendes ved akutte eksacerbationer af skizofreni uden at sikre tilstrækkelig antipsykotisk dækning med oral risperidon eller det forudgående psykofarmakum under den 3-ugers latensperiode, der følger efter den første injektion af Risperdal Consta.”
English: Withdrawal of risperidone may be needed
Danish: Det kan være nødvendigt at stoppe behandlingen med risperidon.
English: • One vial containing RISPERDAL CONSTA extended release microspheres
Danish: • Ét hætteglas indeholdende RISPERDAL CONSTA depotmikrosfærer
English: Therefore, RISPERDAL CONSTA should not be used during pregnancy unless clearly necessary.
Danish: RISPERDAL CONSTA bør derfor kun anvendes på tvingende indikation under graviditet.
English: Discard the vial appropriately.
Danish: Kassér hætteglasset på passende måde.
English: DO NOT STORE THE VIAL AFTER RECONSTITUTION OR THE SUSPENSION MAY SETTLE
Danish: HÆTTEGLASSET MÅ IKKE OPBEVARES EFTER REKONSTITUTION, DA SUSPENSIONEN SÅ KAN BUNDFÆLDES.
English: RISPERDAL CONSTA is used to maintain the treatment of schizophrenia, where you may see, hear or feel things that are not there, believe things that are not true or feel unusually suspicious, or confused RISPERDAL CONSTA is intended for patients who are currently treated with oral (e.g. tablets, capsules) antipsychotics.
Danish: Skizofreni er en tilstand, hvor patienten ser, hører eller føler ting, som ikke er der i virkeligheden, tror ting, der ikke er sande, eller føler sig overdrevet mistænksom eller forvirret.
English: Check with your doctor or pharmacist before using RISPERDAL CONSTA if:
Danish: Tal med lægen eller apoteket, før du bruger RISPERDAL CONSTA, hvis et eller flere af følgende gælder for dig:
English: • Inability to sleep, anxiety, depression, irritability, feeling of inner restlessness
Danish: • Søvnløshed, angst, depression, irritabilitet, indre uro.
English: Where patients are not currently taking oral risperidone, the recommended dose is 25 mg RISPERDAL CONSTA every two weeks.
Danish: Til patienter, som ikke aktuelt tager oral risperidon er den anbefalede dosering 25 mg RISPERDAL CONSTA hver anden uge.
English: RISPERDAL CONSTA should be used with caution in patients with risk factors for stroke.
Danish: RISPERDAL CONSTA bør anvendes med forsigtighed af patienter med risikofaktorer for at få apopleksi.
English: Erythromycin, a CYP 3A4 inhibitor, does not change the pharmacokinetics of risperidone and the active antipsychotic fraction.
Danish: CYP 3A4inhibitoren erythromycin påvirker ikke risperidons farmakokinetik eller den aktive antipsykotiske fraktion.
English: WARNING: To avoid a needle stick injury with a contaminated needle, do not :
Danish: ADVARSEL: Undlad følgende for at undgå kanylestikskader med kontaminerede kanyler:
English: Peel the blister pouch of the Needle-Pro device open half way.
Danish: Åbn blisterposen omkring Needle-Pro® udstyret halvt.
English: • Mishandle the needle protection device that could lead to protrusion of the needle from it
Danish: • At fejlhåndtere kanylebeskyttelseshylsteret på en måde, der kunne føre til, at kanylen kommer til at stikke frem fra dette
English: Unscrew the needle from the syringe and discard the needle appropriately.
Danish: Skru kanylen af sprøjten, og kassér kanylen på passende måde.
English: Disruption of the body's ability to reduce core body temperature has been attributed to antipsychotic medicines.
Danish: Antipsykotika er blevet forbundet med forstyrrelser af kroppens evne til at sænke sin kernetemperatur.
English: b Extrapyramidal disorder may occur: Parkinsonism (salivary hypersecretion, musculoskeletal stiffness, parkinsonism, drooling, cogwheel rigidity, bradykinesia, hypokinesia, masked facies, muscle tightness, akinesia, nuchal rigidity, muscle rigidity, parkinsonian gait, and glabellar reflex abnormal), akathisia (akathisia, restlessness, hyperkinesia, and restless leg syndrome), tremor, dyskinesia (dyskinesia, muscle twitching, choreoathetosis, athetosis, and myoclonus), dystonia.
Danish: b Ekstrapyramidale forstyrrelser kan forekomme: Parkinsonisme (øget spytsekretion, muskuloskeletal stivhed, parkinsonisme, savlen, tandhjulsrigiditet, bradykinesi, hypokinesi, maskeansigt, hårde muskler, akinesi, nakkestivhed, muskelrigiditet, parkinson-gang og unormal glabella refleks), akatisi (akatisi, rastløshed, hyperkinesi og ”restless leg” syndrom), tremor, dyskinesi (dyskinesi, muskeltrækninger, choreoatetose, athetose og myoklonus), dystoni.
English: Patients on higher dosages of the used oral antipsychotic should be considered for the higher Risperdal Consta dose of 37.5 mg.”
Danish: For patienter på højere doser af det anvendte orale psykofarmakum bør man overveje den højere Risperdal Const-dosis på 37,5 mg.”
English: Amitriptyline does not affect the pharmacokinetics of risperidone or the active antipsychotic fraction.
Danish: Amytriptylin påvirker hverken risperidons farmakokinetik eller den aktive antipsykotiske fraktion.
English: • Medicines that cause low blood potassium (e.g. certain diuretics)
Danish: • Medicin, som kan medføre lavt indhold af kalium i blodet (f.eks. bestemte vanddrivende midler)
English: Risperdal should be used with caution in patients with pre-existing hyperprolactinaemia and in patients with possibly prolactin-dependent tumours.”
Danish: Risperdal bør anvendes med forsigtighed til patienter med hyperprolaktinæmi og til patienter med mulige prolaktin-afhængige tumorer.”
English: Fluoxetine and paroxetine, CYP 2D6 inhibitors, increase the plasma concentration of risperidone, but less so of the active antipsychotic fraction.
Danish: CYP 2D6-inhibitorerne fluoxetin og paroxetin øger plasmakoncentrationen af risperidon, men niveauet af den aktive antipsykotiske fraktion øges ikke i tilsvarende grad.
English: Open the cover of one reconstitution needle.
Danish: Åbn hylsteret på en af rekonstitutionskanylerne.
English: Hepatic and renal impairment RISPERDAL CONSTA has not been studied in hepatically and renally impaired patients.
Danish: Lever- og nyreinsufficiens RISPERDAL CONSTA er ikke undersøgt til patienter med lever- og nyreinsufficiens.
English: the CHMP has recommended the amendment of the Marketing Authorisations for which the Summary of Product Characteristics, labelling and package leaflet are set out in Annex III for Risperdal Consta and associated names (see Annex I).
Danish: Produktresumé, etikettering og indlægsseddel fremgår af bilag III for Risperdal Consta og tilknyttede navne (se bilag I).
English: Dystonia includes dystonia, muscle spasms, hypertonia, torticollis, muscle contractions involuntary, muscle contracture, blepharospasm, oculogyration, tongue paralysis, facial spasm, laryngospasm, myotonia, opisthotonus, oropharyngeal spasm, pleurothotonus, tongue spasm, and trismus.
Danish: Dystoni omfatter dystoni, muskelspasmer, hypertoni, torticollis, ufrivillige muskelkontraktioner, muskelkontraktur, blepharospasmer, okulogyration, tungeparalyse, faciale spasmer, laryngospasmer, myotoni, opisthotonus, oropharyngeale spasmer, pleurothotonus, tungespasmer og trismus.
English: RISPERDAL CONSTA should not be used in acute exacerbations of schizophrenia without ensuring sufficient antipsychotic coverage with oral risperidone or the previous antipsychotic during the threeweek lag period following the first RISPERDAL CONSTA injection.
Danish: RISPERDAL CONSTA bør ikke anvendes ved akut forværring af skizofreni uden at der sikres tilstrækkelig behandlingsdækning med oral risperidon eller det antipsykotikum, som anvendtes, under en 3-ugers indkøringsperiode efter den første injektion med RISPERDAL CONSTA.
English: Janssen-Cilag International NV, Belgium Turnhoutseweg 30, 2340 Beerse, Belgium
Danish: Janssen-Cilag International NV, Belgien Turnhoutseweg 30, 2340 Beerse, Belgien
English: Janssen Pharmaceutica N.V. Turnhoutseweg 30
Danish: Janssen Pharmaceutica N.V.
English: RISPERDAL CONSTA should be used cautiously in patients with a history of seizures or other conditions that potentially lower the seizure threshold.
Danish: RISPERDAL CONSTA bør anvendes med forsigtighed til patienter med tidligere krampeanfald eller andre tilstande, som potentielt sænker krampetærsklen.
English: Although extensive metabolisers have lower risperidone and higher 9-hydroxy-risperidone concentrations than poor metabolisers, the pharmacokinetics of risperidone and 9-hydroxy-risperidone combined (i.e., the active antipsychotic fraction), after single and multiple doses, are similar in extensive and poor metabolisers of CYP 2D6.
Danish: Selvom personer med hurtig CYP 2D6-funktion har en lavere koncentration af risperidon og en højere koncentration af 9-hydroxyrisperidon end de personer, der har en langsom CYP 2D6-funktion, er farmakokinetikken af risperidon og 9-hydroxyrisperidon kombineret (dvs. den aktive antipsykotiske fraktion) ens.
English: Janssen Cilag International NV Turnhoutseweg 30, 2340 Beerse, Belgium
Danish: Janssen Cilag International NV Turnhoutseweg 30, 2340 Beerse, Belgien
English: • The usual dose is 25 mg every two weeks as an injection
Danish: Vedligeholdelsesdosis • Den sædvanlige dosis er 25 mg hver anden uge som en injektion.
English: Cases of abnormal electrical conduction in the heart and convulsion have been reported
Danish: Der er set tilfælde af ledningsforstyrrelser i hjertet og krampeanfald.
English: Priapism Psychiatric disorders Very common Depression, Insomnia, Anxiety Common
Danish: Meget almindelig Depression, søvnløshed, angst Almindelig
English: RISPERDAL CONSTA should be used with caution in patients with preexisting hyperprolactinaemia and in patients with possible prolactin-dependent tumours.
Danish: RISPERDAL CONSTA skal anvendes med forsigtighed til patienter med hyperprolactinæmi og til patienter med mulige prolactin-afhængige tumorer.
English: Agranulocytosis Nervous system disorders Very common Parkinsonismb, Akathisiab, Headache Common
Danish: Nervesystemet Meget almindelig Parkinsonismeb, akatisib , hovedpine
English: Tonsillitis, Cellulitis, Otitis media, Eye infection, Acarodermatitis, Respiratory tract infection, Onychomycosis, Otitis media chronic Blood and Lymphatic Disorders
Danish: Tonsillitis, cellulitis, otitis media, øjenbetændelse, akarodermatitis, luftvejsinfektion, onykomykose, kronisk otitis media
English: Sufficient antipsychotic coverage with oral risperidone or the previous antipsychotic should be ensured during the three-week lag period following the first RISPERDAL CONSTA injection (see section 5.2).
Danish: Tilstrækkelig antipsykotisk behandlingsdækning med oral risperidon eller det forudgående antipsykotikum bør sikres under en 3-ugers indkøringsperiode efter den første injektion med RISPERDAL CONSTA (se pkt.
English: Reproductive System and Breast Disorders Ejaculation disorder, Vaginal discharge, Menstrual disorder General Disorders and Administration Site Conditions Generalised oedema, Face oedema, Gait disturbance, Thirst, Chills, Peripheral coldness, Drug withdrawal syndrome
Danish: Ejakulationsforstyrrelser, vaginalsekretion, menstruationsforstyrrelser Almene symptomer og reaktioner på administrationsstedet Generaliseret ødem, ansigtsødem, gangforstyrrelser, tørst, kulderystelser, perifer kulde, seponeringssyndrom
English: Confusional state, Listless, Anorgasmia, Blunted affect Nervous System Disorders
Danish: Konfusionstilstand, apati, anorgasmi, følelsesmæssig tilbagetrækning Nervesystemet
English: The recommended starting dose is 25 mg Risperdal Consta every two weeks.
Danish: Den anbefalede startdosis er 25 mg RISPERDAL CONSTA hver anden uge.
English: The recommended starting dose is 25 mg RISPERDAL CONSTA every two weeks.
Danish: Den anbefalede startdosis er 25 mg Risperdal Consta hver anden uge.
English: Take special care with RISPERDAL CONSTA
Danish: Vær ekstra forsigtig med at tage RISPERDAL CONSTA
English: Rare side effects (affects 1 to 10 users in 10,000):
Danish: Sjældne bivirkninger (forekommer hos 1 til 10 ud af 10.000 patienter):
English: Bundle branch block, Atrial fibrillation, Bradycardia, Sinus bradycardia, Palpitations Blood and lymphatic system disorders Common
Danish: Ikke almindelig Grenblok, atrieflimren, bradykardi, sinusbradykardi, palpitationer Blod og lymfesystem
English: Sufficient antipsychotic coverage should be ensured during the three-week lag period following the first RISPERDAL CONSTA injection (see section 5.2).
Danish: Tilstrækkelig antipsykotisk behandlingsdækning bør sikres under en 3-ugers indkøringsperiode efter den første injektion med RISPERDAL CONSTA (se pkt.
English: sleepiness
Danish: søvnighed.
English: Open the cover of the second reconstitution needle.
Danish: Åbn hylsteret på den anden rekonstitutionskanyle.
English: • Gait disturbance, edema, body temperature increased, drug allergy, speech disorder, movement disorder
Danish: • Gangforstyrrelser, væskeansamling, forhøjet legemstemperatur, lægemiddelallergi, taleforstyrrelser,
English: RISPERDAL CONSTA come in a form of a powder that must be mixed with only the solution in the syringe supplied in the dose pack, and must be administered only with the Needle-Pro safety needle supplied in the dose pack.
Danish: RISPERDAL CONSTA leveres som et pulver, der kun må blandes med opløsningsmidlet i den injektionssprøjte, der leveres i produktpakken, og kun må indgives med den Needle-Pro sikkerhedskanyle, der leveres i produktpakken.
English: Contents of the dose pack:
Danish: Produktpakkens indhold:
English: Skin lesion, Skin disorder, Skin discoloration, Seborrheic dermatitis, Hyperkeratosis, Dandruff, Erythema
Danish: Hudlæsion, hudforstyrrelser, misfarvning af huden, seborroisk dermatitis, hyperkeratose, skæl, erytem
English: Hold the skirt of the vial access device during attachment to prevent spinning.
Danish: Hold fast i svøbet omkring adgangsudstyret, så det ikke drejer sig.
English: • One prefilled syringe containing the solvent for RISPERDAL CONSTA
Danish: • Én fyldt injektionssprøjte med opløsningsmiddel til RISPERDAL CONSTA
English: PHARMACEUTICAL FORM AND CONTENTS Powder and solvent for prolonged-release suspension for injection.
Danish: LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE) Pulver og solvens til depotinjektionsvæske, suspension.
English: affects 1 to 10 users in 1,000
Danish: forekommer hos 1 til 10 ud af 1.000 patienter
English: affects 1 to 10 users in 100
Danish: forekommer hos 1 til 10 ud af 100 patienter
English: Respiratory, Thoracic, and Mediastinal Disorders Wheezing, Pneumonia aspiration, Pulmonary congestion, Respiratory disorder, Rales, Epistaxis, Respiratory tract congestion, Hyperventilation, Dysphonia Gastrointestinal Disorders
Danish: Hvæsende vejrtrækning, aspirationspneumoni, pulmonal kongestion, respirationsforstyrrelser, rhonchi, epistaxis, luftvejskongestion, hyperventilation, dysfoni Mave-tarm-kanalen
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER [See Annex I - To be completed nationally] {Name and Address}
Danish: NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN [Se Bilag I - udfyldes nationalt] {Navn og adresse}
English: Vomiting, Diarrhoea, Constipation, Nausea, Abdominal pain, Dyspepsia, Toothache, Dry mouth, Stomach discomfort, Gastritis
Danish: Opkastning, diaré, obstipation, kvalme, abdominalsmerter, dyspepsi, tandpine, mundtørhed, abdominalgener, gastritis