FrancophonIA/ELRC3.0 huggingface dataset:
English: MARKETING AUTHORISATION HOLDER [See Annex I - To be completed nationally] {Name and address}
Danish: INDEHAVER AF MARKEDSFØRINGSTILLADELSEN [Se Bilag I - udfyldes nationalt] {Navn og adresse}
English: Common side effects (affects 1 to 10 users in 100):
Danish: Almindelige bivirkninger (forekommer hos 1 til 10 ud af 100 patienter):
English: The pharmacokinetics of risperidone following single doses of RISPERDAL CONSTA are linear in the dose range of 12.5-75 mg.
Danish: Risperidons farmakokinetik efter enkeltdoser af RISPERDAL CONSTA er lineær i dosisområdet 12,5-75 mg. Risperidons farmakokinetik er også lineær i dosisområdet 25-50 mg injiceret hver anden uge.
English: Discard the vial and the vial access device appropriately.
Danish: Kassér hætteglasset og hætteglasadgangsudstyret på passende måde.
English: Very rare:
Danish: Meget sjældne bivirkninger:
English: • Wheezing, pneumonia caused by inhaling food, hoarseness, cough with sputum, lung congestion, breathing passage congestion, crackly lung noise, breathing passage disorder, fast shallow breathing
Danish: • Hvæsende vejrtrækning, lungebetændelse forårsaget af indånding af fødevarer, hæshed, hoste med opspyt, tilstoppede lunger, tilstoppede luftveje, knitrende lyd i lungerne, luftvejsforstyrrelser, hurtigt overfladisk åndedræt.
English: Body temperature increased, Eosinophil count increased, White blood cell count decreased, Haemoglobin decreased, Blood creatine phosphokinase increased, Body temperature decreased
Danish: Forhøjet legemstemperatur, stigning i eosinofiltal, fald i hvide blodceller, fald i hæmoglobin, stigning i blodkreatinfosfokinase, fald i legemstemperatur Infektioner og parasitære sygdomme
English: You may be given a lower dose of 12.5 mg.
Danish: 4.5), kan det være mere passende med en dosisreduktion ned til 12,5 mg.
English: RISPERDAL CONSTA is given as an intramuscular injection into the buttocks every two weeks, administered by a health care professional.
Danish: RISPERDAL CONSTA indgives som en injektion i en muskel i ballen hver anden uge.
English: Marketing Authorisation Holder and Manufacturer [See Annex I - To be completed nationally] {Name and address}
Danish: Indehaveren af markedsføringstilladelsen og fremstiller [Se Bilag I - udfyldes nationalt] {Navn og adresse}
English: affects 1 to 10 users in 10,000
Danish: forekommer hos 1 til 10 ud af 10.000 patienter
English: Amenorrhoea, Erectile dysfunction, Galactorrhoea
Danish: Amenoré, erektil dysfunktion, galaktoré Ikke almindelig Seksuel dysfunktion, gynækomasti Ikke kendt
English: After procedure is completed, press the needle into the needle protection device.
Danish: Efter proceduren trykkes kanylen ind i kanylebeskyttelseshylsteret ved en enhåndsteknik.
English: • Restlessness, sleep disorder, dizziness, feeling dizzy when staying still, fatigue, drowsiness,
Danish: • Rastløshed, søvnforstyrrelser, svimmelhed, svimmelhed i opretstående stilling, træthed, døsighed,
English: • One Needle-Pro needle for intramuscular injection (safety 20G 2” TW needle with needle protection device)
Danish: • Én Needle-Pro-kanyle til intramuskulær injektion (20G 2" TW-sikkerhedskanyle med kanylebeskyttelseshylster)
English: • Unresponsive to stimuli, stroke, decreased blood supply to the brain, brain blood vessel disorder, sudden weakness or numbness of the face, arms, or legs, especially on one side, or instances of slurred speech that last for less than 24 hours (these are called mini-strokes or strokes)
Danish: • Manglende reaktion på stimulation, slagtilfælde, nedsat blodforsyning til hjernen, forstyrrelser i hjernens blodårer, pludselig svaghed eller følelsesløshed i ansigt, arme eller ben, især i den ene side,
English: In patients with clinical factors such as hepatic or renal impairment or certain drug interactions that increase risperidone plasma concentrations (see section 4.5), dose reduction as low as 12.5 mg may be appropriate.
Danish: Hos patienter med kliniske faktorer såsom lever- eller nyreinsufficiens eller særlige lægemiddelinteraktioner, der øger plasmakoncentrationerne af risperidon (se pkt.
English: Administration of partial contents may not deliver the intended dose of risperidone.
Danish: Hvis kun noget af indholdet indgives, bliver hele den ønskede risperidondosis ikke indgivet.
English: For most patients the recommended dose is 25 mg intramuscular every two weeks.
Danish: Til de fleste patienter er den anbefalede dosis 25 mg intramuskulært hver anden uge.
English: This leaflet was last approved in {MM/YYYY}.
Danish: [Se bilag I - udfyldes nationalt] Denne indlægsseddel blev senest godkendt { MM/ÅÅÅÅ }.
English: Electrocardiogram abnormal, Blood prolactin increaseda, Blood glucose increased, Hepatic enzyme increased, Transaminases increased, Gamma-glutamyltransferase increased, Weight increased, Weight decreased
Danish: Unormalt elektrokardiogram, forhøjet blodprolactina, stigning i blodglucose, stigning i leverenzymer, stigning i transaminaser, stigning i gammaglutamyltransferase,vægtøgning, vægttab Ikke almindelig QT-forlængelse ved elektrokardiogram Hjerte Almindelig
English: “For most patients the recommended dose is 25 mg intramuscular every two weeks.
Danish: “For de fleste patienter er den anbefalede dosis 25 mg givet intramuskulært hver anden uge.
English: HOW TO STORE RISPERDAL CONSTA [To be completed nationally]
Danish: SÅDAN OPBEVARER DU RISPERDAL CONSTA [Udfyldes nationalt]
English: Cerebrovascular adverse events (CVAE)
Danish: Uønskede cerebrovaskulære hændelser
English: RISPERDAL CONSTA extended release microspheres in the vial must be reconstituted only in the solvent in the syringesupplied in the dose pack, and must be administered only with the Needle-Pro safety needle supplied in the dose pack.
Danish: RISPERDAL CONSTA depotmikrosfærer i hætteglasset må kun rekonstitueres i opløsningsmidlet i den injektionssprøjte, der leveres i produktpakken, og må kun indgives med den Needle-Pro sikkerhedskanyle, der leveres i produktpakken.
English: Elderly, hepatic and renal impairment
Danish: Ældre samt patienter med lever- og nyreinsufficiens
English: Ocular hyperemia, Eye discharge, Eye swelling, Dry eye, Lacrimation increased, Photophobia, Visual acuity reduced, Eye rolling, Glaucoma Ear and Labyrinth Disorders
Danish: Okulær hyperæmi, øjenflåd, hævede øjne, øjentørhed, øget tåreflåd, fotofobi, nedsat synsstyrke, øjenrulning, glaukom
English: The recommended dose is 25 mg intramuscularly every two weeks.
Danish: Den anbefalede dosis er 25 mg intramuskulært hver anden uge.
English: 25 mg suspension for injection
Danish: 25 mg pulver og solvens til suspension
English: Dysphagia, Faecal incontinence, Faecaloma, Lip swelling, Cheilitis Skin and Subcutaneous Tissue Disorders
Danish: Dysfagi, fækal inkontinens, fækalom, hævede læber, keilitis Hud og subkutane væv
English: starting dose.
Danish: startdosis.
English: For identification purposes, tear section of the vial label at the perforation and apply detached section to the syringe.
Danish: For at sikre identifikation skal den afrivelige del af hætteglassets etiket tages af og sættes på sprøjten.
English: Patients treated with a dosage of 4 mg or less oral risperidone should receive 25 mg Risperdal Consta, while patients treated with higher oral doses should be considered for the higher Risperdal Consta dose of 37.5 mg.
Danish: Patienter, som er behandlet med en dosis på 4 mg eller mindre oral risperidon, skal modtage 25 mg RISPERDAL CONSTA, mens en højere RISPERDAL CONSTA-dosis på 37,5 mg bør overvejes til patienter, som er behandlet med højere orale doser.
English: Instructions for Needle-Free Vial Access Device
Danish: Vejledning i anvendelse af nålefrit hætteglasadgangsudstyr
English: Uncommon side effects (affects 1 to 10 users in 1000):
Danish: Ikke almindelige bivirkninger (forekommer hos 1 til 10 ud af 1.000 patienter):
English: • Discomfort, chills, arm or leg coldness, drug withdrawal syndrome.
Danish: • Utilpashed, kulderystelser, kulde i arme eller ben, seponeringssyndrom (som optræder, når man holder op med at tage et lægemiddel).
English: RISPERDAL CONSTA and associated names (see Annex I) 12.5, 25, 37.5 and 50 mg powder and solvent for prolonged-release suspension for intramuscular injection [See Annex I - To be completed nationally] Risperidone
Danish: RISPERDAL CONSTA og associerede navne (se Bilag I) 12,5, 25, 37,5 og 50 mg pulver og solvens til depotinjektionsvæske, suspension til intramuskulær injektion [Se Bilag I - udfyldes nationalt]
English: Vision blurred, Conjunctivitis
Danish: Sløret syn, konjunktivitis
English: • Flushing, oily skin inflammation, dandruff, rash all over the body
Danish: • Blussen, olieagtig hudbetændelse, skæl, udslæt over hele kroppen.
English: If you stop using RISPERDAL CONSTA
Danish: Hvis du har fået for meget RISPERDAL CONSTA
English: Powder for Suspension for Injection
Danish: Hætteglas med pulver til suspension til injektion (alle pakninger)
English: Prolonged release powder and solvent for suspension for injection
Danish: Depotinjektionsvæske, pulver og solvens til suspension
English: With a straight push down movement press the spike tip of the vial access device through the centre of the vial's rubber stopper until the device securely snaps onto the vial top.
Danish: Tryk spidsen af hætteglasadgangsudstyret lige ned gennem hætteglassets gummiprop, indtil udstyret siger klik og er på plads.
English: Seat the needle firmly on the Needle-Pro device with a push and clockwise twist.
Danish: Sæt kanylen fast i Needle-Pro® udstyret med et tryk og et vrid i urets retning.
English: Greece
Danish: Grækenland:
English: Base
Danish: Styrke
English: • Abnormal posture, joint stiffness, neck pain, breakdown of muscle and pain in muscles
Danish: • Unormal kropsholdning, stivhed i leddene, nakkesmerter, nedbrydning af muskler og muskelsmerter.
English: • You have kidney problems
Danish: • Hvis du har nyreproblemer.
English: • Tonsillitis, eye infection, skin infection, fungal infection of nails
Danish: • Halsbetændelse, øjenbetændelse, hudbetændelse, svampeinfektion i neglene.
English: Retinal artery occlusion Ear and labyrinth disorders Common
Danish: Øre og labyrint Almindelig
English: Angioedema, Pruritus, Acne, Alopecia, Dry skin Musculoskeletal and connective tissue disorders Common
Danish: Ikke almindelig Angioødem, pruritis, akne, alopeci, tør hud Knogler, led, muskler og bindevæv Almindelig
English: RISPERDAL CONSTA (listed in Section 6 below).
Danish: CONSTA (anført i pkt.
English: Ear pain Respiratory, thoracic and mediastinal disorders Common
Danish: Ikke almindelig Ørepine Luftveje, thorax og mediastinum Almindelig
English: • Weight increased, toothache, weight decreased
Danish: • Vægtøgning, tandpine, vægttab.
English: • Abnormal electrical conduction of the heart, high blood pressure, fast beating heart, chest pain,
Danish: • Ledningsforstyrrelser i hjertet, højt blodtryk, hurtigt hjerteslag, brystsmerter, lavt blodtryk, registrering af unormale elektriske impulser i hjertet (EKG).
English: • Nervousness, poor attention, feeling very sleepy, exhausted, or weary, excessive sleep, elated mood (mania), feeling ‘out of sorts', sluggishness
Danish: • Nervøsitet, nedsat opmærksomhed, søvnighed, udmattelse eller træthed, stort søvnbehov, opstemthed
English: Attach the luer connection of the Needle-Pro device with an easy clockwise twisting motion to the syringe.
Danish: Sæt luerstykket på Needle-Pro® udstyret på sprøjten med en let drejende bevægelse i retning med uret.
English: Take the syringe and pull sheath away from the reconstitution needle - do not twist.
Danish: Tag sprøjten, og træk hylsteret af rekonstitutionskanylen uden at vride.
English: • Rifampicin (a medicine for treating some infections)
Danish: • Kinidin (bruges til behandling af forskellige typer af hjertesygdomme)
English: • Rash, injection site pain, skin redness.
Danish: • Udslæt, smerter på injektionsstedet, rødme på huden.
English: Convulsion, Syncope, Dizziness postural, Hypoaesthesia, Paraesthesia, Lethargy, Hypersomnia
Danish: Ikke almindelig Kramper, synkope, postural svimmelhed, hypoæstesi, paræstesi, letargi, hypersomni
English: Pull sheath away from the needle - do not twist sheath as needle may be loosened from NeedlePro device.
Danish: Fjern hylsteret fra kanylen uden at vride, da dette kan løsne kanylen fra Needle-Pro® udstyret.
English: Inappropriate antidiuretic hormone secretion Metabolism and nutrition disorders Uncommon
Danish: Uhensigtsmæssig ADH-sekretion Metabolisme og ernæring Ikke almindelig Forøget appetit, nedsat appetit Meget sjælden Diabetisk ketoacidose Ikke kendt
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients [To be completed nationally] 6.2 Incompatibilities [To be completed nationally] 6.3 Shelf life [To be completed nationally] 6.4 Special precautions for storage [To be completed nationally]
Danish: FARMACEUTISKE OPLYSNINGER 6.1 Hjælpestoffer [Udfyldes nationalt]
English: Keeping the empty syringe and needle aligned, attach the second needle with an easy clockwise twisting motion to the luer connection of the syringe.
Danish: Hold den tomme sprøjte og kanylen, så de flugter, og sæt den anden kanyle på luerspidsen af sprøjten med en let drejende bevægelse i retning med uret.
English: Bulgaria
Danish: Bulgarien:
English: Hyperglycemia
Danish: Hyperglycæmi
English: • Tremor, muscle weakness, fall, back pain, muscle spasm, pain in arms and legs, joint pain,
Danish: • Rysten, muskelsvaghed, fald, rygsmerter, muskelkramper, smerter i arme og ben, ledsmerter, ufrivillige bevægelser i ansigtsmusklerne eller i arm- og benmusklerne, muskelsmerter, hævelser i arme og ben.
English: Injection
Danish: INDLÆGSSEDDEL
English: • Vomiting, diarrhea, constipation, nausea, dry mouth, abdominal pain or stomach discomfort,
Danish: • Opkastning, diaré, forstoppelse, kvalme, mundtørhed, mavesmerter eller mavegener, maveinfektion.
English: • Very hard feces, fecal incontinence, abdominal discomfort, thirst, lip swelling, inflammation of the colon, reduced saliva
Danish: • Meget hård afføring, problemer med at holde på afføringen, mavegener, tørst, hævede læber,
English: injection containing 12.5, 25, 37.5, or 50 mg risperidone.
Danish: Den godkendte sammensætning af Risperdal Consta er et depotpræparat til intramuskulær injektion indeholdende12,5, 25, 37,5 eller 50 mg risperidon.
English: • Bladder infection, stomach and intestine infection, ear pain
Danish: • Blærebetændelse, mave-tarm-infektion, ørepine.
English: Whereas
Danish: CONSTA
English: • Eye discharge, eye rolling, eye swelling, ringing in the ears, nose bleeding, dry eye, increased tears, painful oversensitivity to light, increased pressure within the eyeball, reduced visual clarity
Danish: • Løbende øjne, øjenrulning, hævede øjne, ringen for ørerne, næseblod, øjentørhed, øget tåreflåd,
English: Diabetic ketoacidosis
Danish: Retinal arterieokklusion
English: Thrombocytopenia, Neutropenia
Danish: Ikke almindelig Trombocytopeni, neutropeni Ikke kendt
English: Seizures
Danish: Vægtøgning
English: • Intense itching of the skin, reduced sensation of skin to pain and touch, a sensation of tingling,
Danish: • Intens hudkløe, nedsat følsomhed i huden for smerte og berøring, fornemmelse af stikken, prikken eller følelsesløshed i huden, byld under huden, hårtab, bumser, tør hud.
English: Musculoskeletal, Connective Tissue, and Bone Disorders Rhabdomyolysis, Joint swelling, Posture abnormal, Joint stiffness Renal and Urinary Disorders
Danish: Rhabdomyolyse, hævede led, unormal holdning, ledstivhed Nyrer og urinveje
English: RISPERDAL CONSTA and associated names (see Annex I) 12.5 mg powder and solvent for prolonged-release suspension for intramuscular injection [See Annex I - To be completed nationally]
Danish: RISPERDAL CONSTA og associerede navne (se Bilag I) 12,5 mg pulver og solvens til depotinjektionsvæske, suspension til intramuskulær injektion [Se Bilag I - udfyldes nationalt]
English: RISPERDAL CONSTA and associated names (see Annex I) 37.5 mg powder and solvent for prolonged-release suspension for intramuscular injection
Danish: RISPERDAL CONSTA og associerede navne (se Bilag I) 37,5 mg pulver og solvens til depotinjektionsvæske, suspension til intramuskulær injektion
English: Spain
Danish: Spanien:
English: Pyrexia, Peripheral oedema, Chest pain, Fatigue, Pain, Injection site pain, Asthenia, Influenza like illness
Danish: Pyreksi, perifert ødem, brystsmerter, træthed, smerter, smerter på injektionsstedet, asteni, influenzalignende sygdom Ikke almindelig Unormalitetsfølelse, brystgener, induration, induration på injektionsstedet, træghed, reaktioner på injektionsstedet
English: Janssen Pharmaceutica N.V. Turnhoutseweg 30, 2340 Beerse, Belgium
Danish: Turnhoutseweg 30, 2340 Beerse, Belgien
English: Keep the syringe and the vial access device aligned.
Danish: Hold sprøjten og hætteglasadgangsudstyret, så de flugter.
English: Prolonged-release powder and solvent for solution for injection
Danish: Depotinjektionsvæske, pulver og solvens til
English: RISPERDAL CONSTA and associated names (see Annex I) 50 mg powder and solvent for prolongedrelease suspension for intramuscular injection
Danish: RISPERDAL CONSTA og associerede navne (se Bilag I) 50 mg pulver og solvens til depotinjektionsvæske, suspension til intramuskulær injektion
English: Insert the reconstitution needle into the upright vial.
Danish: Stik rekonstitutionskanylen i det opretstående hætteglas.
English: Cystitis, Gastroenteritis, Infection, Localised infection, Subcutaneous abscess
Danish: urinvejsinfektion, øreinfektion, sinusitis, virusinfektion Ikke almindelig Cystitis, gastroenteritis, infektion, lokaliseret infektion, subkutan absces Traumer, forgiftninger og behandlingskomplikationer Almindelig
English: Even if you are not being treated with RISPERDAL Oral but you experience any of the following, talk to your doctor:
Danish: Tal med lægen, hvis du får en eller flere af nedenstående bivirkninger, selv om du ikke bliver behandlet med RISPERDAL Oral:
English: If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before using RISPERDAL or RISPERDAL CONSTA.
Danish: Tal med lægen eller apoteket, før du tager RISPERDAL eller RISPERDAL CONSTA, hvis du ikke er sikker på, om nogle af ovenstående tilfælde er relevante for dig.
English: Pneumonia, Influenza, Lower respiratory tract infection, Bronchitis, Urinary tract infection, Ear infection, Sinusitis, Viral infection
Danish: Lungebetændelse, influenza, infektion i de nedre luftveje, bronkitis,
English: Romania
Danish: Rumænien:
English: Sexual dysfunction, Gynaecomastia
Danish: Aktivt stof: risperidon
English: RISPERDAL CONSTA and associated names (see Annex I) 25 mg powder and solvent for prolongedrelease suspension for intramuscular injection
Danish: RISPERDAL CONSTA og associerede navne (se Bilag I) 25 mg pulver og solvens til depotinjektionsvæske, suspension til intramuskulær injektion
English: Invented Name Strength
Danish: Særnavn
English: • Obstruction of intestine
Danish: Intestinal obstruktion, pankreatitis
English: RISPOLEPT® CONSTA® Liechtenstein:
Danish: Liechtenstein:
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Pre filled Syringe (all packs)
Danish: Fyldt injektionssprøjte (alle pakninger)
English: • Neck pain, buttock pain, musculoskeletal chest pain, pain during injection procedure, chest discomfort, swelling and thickening of skin at injection site
Danish: • Nakkesmerter, smerter i endeballen, muskel- og skeletsmerter i brystet, smerter under injektionen,
English: Sleep apnea syndrome Gastrointestinal disorders Common
Danish: Søvnapnøsyndrom Mave-tarm-kanalen Almindelig
English: PHARMACEUTICAL FORM AND CONTENTS
Danish: Lægemiddelform Indgivelsesvej
English: BEFORE YOU USE RISPERDAL CONSTA
Danish: DET SKAL DU VIDE, FØR DU BEGYNDER AT TAGE RISPERDAL CONSTA
English: RISPERDAL® CONSTA Hungary: RISPERDAL CONSTA Iceland:
Danish: RISPERDAL CONSTA indeholder:
English: Keeping the syringe and needle aligned, attach the needle with an easy clockwise twisting motion to the luer connection of the syringe.
Danish: Hold sprøjten og kanylen, så de flugter, og sæt kanylen på luerspidsen af sprøjten med en let drejende bevægelse i retning med uret.
English: A lower initial dose of 12.5 mg may be appropriate when clinical factors warrant dose adjustment, such as in patients with hepatic or renal impairment, for certain drug interactions that increase risperidone plasma concentrations (see section 4.5), or in patients who have a history of poor tolerability to psychotropic medications.
Danish: Det kan f.eks. være ved nedsat lever- og nyrefunktion, ved visse lægemiddelinteraktioner, der øger plasmakoncentrationerne af risperidon (se pkt.
English: Solvent for RISPERDAL CONSTA 12.5 mg/25 mg/37.5 mg/50 mg and associated names (see Annex I) [See Annex I - To be completed nationally]
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Solvens til RISPERDAL CONSTA 37,5 mg og associerede navne (se Bilag I) [Se Bilag I - udfyldes nationalt]
English: • Difficulty breathing, lung infection (pneumonia), flu, infection of the breathing passages,
Danish: • Åndedrætsbesvær, lungebetændelse, influenza, luftvejsinfektion, urinvejsinfektion, stigning i legemstemperaturen, problemer med at holde på vandet, bihulebetændelse, virusinfektion,
English: Hoffsveien 1D 0275 Oslo Norway powder (microspheres) and a solvent for suspension for injection
Danish: 0275 Oslo Norge suspension
English: • No menstruation, erectile dysfunction, breast discharge
Danish: • Udebleven menstruation, rejsningsproblemer, mælkeflåd.
English: Patients on higher dosages of the used oral antipsychotic should be considered for the higher RISPERDAL CONSTA dose of 37.5 mg.
Danish: En højere RISPERDAL CONSTA-dosis på 37,5 mg bør overvejes til patienter, som behandles med højere doser oral antipsykotika.
English: Solvent (solution) [To be completed nationally]
Danish: Opløsningsmiddel [Udfyldes nationalt]
English: Common:
Danish: LOT:
English: Hypothermia Immune system disorders Uncommon
Danish: Ikke almindelig Hypersensitivitet Ikke kendt
English: Pull sheath away from the needle - do not twist.
Danish: Træk hylsteret af kanylen uden at vride.
English: Peel back the blister pouch and remove the vial access device by holding the white luer cap. Do not touch the spike tip of the access device at any time.
Danish: Åbn blisterposen, og tag hætteglasadgangsudstyret ud ved at holde på den hvide luerspids.
English: --1 Modified live Porcine Respiratory and Reproductive Syndrome Virus, strain 96V198: 102.2 - 105.2 CCID50* per 2 ml *Cell culture infectious dose 50%
Danish: --1 Modificeret levende Porcin reproduktions- og respirationssygdom virus (PRRSV), stamme 96V198: 102,2 - 105,2 CCID50* per 2 ml * 50 % cellekultur infektiøs dosis (Cell culture infectious dose 50%)
English: Packaging Content
Danish: Indgivelsesvej Emballage Indhold Pakningss -tørrelse
English: Package size
Danish: 100 ml
English: Dogs should be treated for as long as is needed.
Danish: Hunde bør behandles, så længe det er nødvendigt.
English: Onsior received a marketing authorisation valid throughout the EU on 16 December 2008.
Danish: Onsior fik en markedsføringstilladelse med gyldighed i hele EU den 16. december 2008.
English: In very rare cases, lethargy may be observed.
Danish: I meget sjældne tilfælde kan iagttages sløvhed.
English: Further information on Onsior can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Danish: Yderligere information om Onsior findes på agenturets websted under: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: Hands should be washed after giving the medicine to a dog or cat.
Danish: Der bør vaskes hænder efter at lægemidlet er givet til en hund eller en kat.
English: Other information about Onsior:
Danish: Andre oplysninger om Onsior:
English: It works by blocking an enzyme called cyclooxygenase 2 (COX-2).
Danish: Det virker ved at blokere enzymet cyclooxygenase 2 (COX-2).