FrancophonIA/ELRC3.0 huggingface dataset:
English: The above mentioned product Xefo and its associated names, do not have the same Product Information (Summary of Product Characteristics (SPC), package leaflet (PL) and labelling) across all EU Member States with respect to e.g.
Danish: For ovennævnte produkt, Xefo og tilknyttede navne, er produktinformationen (produktresumé, indlægsseddel og etikettering) ikke ens i alle medlemsstater i EU hvad angår f.eks. indikationer, dosering, kontraindikationer, bivirkninger eller afsnittene med anbefalinger vedrørende anvendelsen.
English: That an initial lornoxicam rapid (QR) dose of 16 mg followed by 8 mg 12 hours later on the first treatment day is significantly better than giving lornoxicam rapid 8 mg bid has not been fully demonstrated.
Danish: Det er ikke fuldt ud bevist, at en initialdosis af lornoxicam (hurtig udløsning) på 16 mg, efterfulgt af 8 mg efter 12 timer i det første døgn af behandlingen, er væsentligt bedre end lornoxicam med hurtig udløsning, 8 mg to gange dagligt.
English: In animals, administration of prostaglandin synthesis inhibitor has been shown to result in increased pre- and post- implantation loss and embryo-foetal lethality.
Danish: I dyr har administration af prostaglandinsyntesehæmmere resulteret i forhøjet præ- og postimplantationstab og embryo/føtal letalitet.
English: Intramuscular or intravenous use
Danish: Til intravenøs eller intramuskulær brug.
English: Eye disorders Uncommon: Conjuctivitis Rare: Visual disturbances.
Danish: Ikke almindelig: Conjunctivitis Sjælden: Synsforstyrrelser.
English: Only 2/7 studies included a 16 mg dose and only 1/7 study included a 32 mg dose.
Danish: Kun i to af de syv undersøgelse anvendtes en dosis på 16 mg, og kun i én af de syv undersøgelser anvendtes en dosis på 32 mg. Dosis-responssammenhængen op til 16 mg bygger på to undersøgelser.
English: 4.1 Therapeutic indications Short-term relief of acute mild to moderate pain.
Danish: 4.1 Terapeutiske indikationer Kortvarig lindring af akutte, milde til moderate smerter
English: - Corticosteroids: Increased risk of gastrointestinal ulceration or bleeding (see section 4.4).
Danish: - kortikosteroider: medfører øget risiko for gastrointestinalt ulcus eller gastrointestinal blødning (se pkt.
English: The MAH considered study CT80, comparing 4 mg bid and 8 mg bid to placebo, and study CT63, comparing 4 mg tid to 8 mg bid, and to 50mg diclofenac tid, as pivotal.
Danish: Indehaveren af markedsføringstilladelsen anså de vigtigste undersøgelser for at være CT80, hvor 4 mg to gange dagligt og 8 mg to gange dagligt blev sammenlignet med placebo, og CT63, hvor 4 mg tre gange dagligt blev sammenlignet med 8 mg to gange dagligt og med diclofenac, 50 mg tre gange dagligt.
English: Concomitant treatment with NSAIDs and heparin in the context of a spinal or epidural anaesthesia increases the risk of spinal/epidural haematoma (see section 4.5).
Danish: Samtidig behandling med NSAID-præparater og heparin i forbindelse med spinal- eller epiduralanæstesi øger risikoen for spinalt/epiduralt hæmatom (se pkt.
English: How to store Xefo Rapid Further information
Danish: Sådan skal du opbevare Xefo Rapid Yderligere oplysninger
English: Lornoxicam “Nycomed” 4 mg/ml Powder and solvent for solution for injection
Danish: Lornoxicam “Nycomed” 4 mg/ml Pulver og solvens til injektionsvæske, opløsning
English: EXPIRY DATE
Danish: UDLØBSDATO Anv.før
English: Blister: Do not store above 30 °C
Danish: Blister: Må ikke opbevares over 30 ºC.
English: In the case of a real or suspected overdose, the medication should be withdrawn.
Danish: Ved overdosering eller mistanke om overdosering bør behandlingen straks seponeres.
English: 4 mg/ml Powder and solvent for solution for injection
Danish: 4 mg/ml Pulver og solvens til injektionsvæske, opløsning
English: For patients with moderate hepatic impairment the maximum recommended daily dose is 12 mg divided in 2 or 3 doses (see section 4.4).
Danish: Til patienter med moderat nedsat leverfunktion er den maksimalt anbefalede døgndosis 12 mg fordelt på 2 - 3 doser (se pkt.
English: 4 mg Film-coated tablet
Danish: 4 mg Filmovertrukne tabletter
English: One vial contains 8 mg lornoxicam.
Danish: Et hætteglas indeholder 8 mg lornoxicam.
English: You should check with your doctor or pharmacist if you are not sure.
Danish: Kontakt din læge eller apoteket, hvis du er i tvivl.
English: 4.1 Therapeutic indications - Short-term relief of acute mild to moderate pain - Symptomatic relief of pain and inflammation in osteoarthritis.
Danish: 4.1 Terapeutiske indikationer - Kortvarig lindring af akutte, milde til moderate smerter - Symptomatisk lindring af smerter og inflammation ved osteoarthritis.
English: Simultaneous intake of lornoxicam with meals reduces Cmax by approximately 30 % and Tmax increases from 1.5 to 2.3 hours.
Danish: Ved indtagelse af lornoxicam samtidig med et måltid reduceres Cmax med ca. 30 %.
English: Patients showing dizziness and/or sleepiness under treatment with lornoxicam should refrain from driving or operation machinary.
Danish: Patienter, der som følge af behandlingen med lornoxicam bliver svimle eller søvnige, bør undgå at føre motorkøretøj eller betjene maskiner.
English: - ACE inhibitors: The antihypertensive effect of the ACE inhibitor may decrease.
Danish: - ACE-hæmmere: den antihypertensive effekt kan nedsættes.
English: 8-16 mg lornoxicam given in doses of 8 mg. An initial dose of 16 mg followed by 8 mg 12 hours later can be given on the first treatment day.
Danish: 8-16 mg i doser på 8 mg. I det første døgn af behandlingen kan gives en initialdosis på 16 mg, efterfulgt af 8 mg efter tolv timer.
English: Daily dose should not exceed 16 mg.
Danish: Daglig dosis bør ikke overstige 16 mg.
English: GENERAL CLASSIFICATION FOR SUPPLY [To be completed nationally]
Danish: GENEREL KLASSIFIKATION FOR UDLEVERING <[Udfyldes nationalt]>
English: Lactose monohydrate Cellulose, microcrystalline Povidone K 30
Danish: Croscarmellosenatrium, lactosemonohydrat, magnesiumstearat, cellulose, mikrokrystallinsk, povidon K 30
English: - Selective serotonin reuptake inhibitors (SSRIs): Increased risk of gastrointestinal bleeding (see section 4.4).
Danish: - SSRI (Selective Serotonine Reuptake Inhibitors): medfører øget risiko for gastrointestinal blødning (se pkt.
English: 8 mg Film-coated tablet
Danish: 8 mg Filmovertrukne tabletter
English: - Symptomatic relief of pain and inflammation in osteoarthritis.
Danish: - Symptomatisk behandling af smerter og inflammation ved osteoartritis.
English: Ask your doctor or pharmacist if you ar uncertain.
Danish: Spørg lægen eller apoteket hvis der er noget, du er i tvivl om eller følger dig usikker på.
English: Rare: Melaena, haematemesis, stomatitis, oesophagitis, gastrooesophageal reflux, dysphagia, aphthous stomatitis, glossitis, perforated peptic ulcer.
Danish: Sjælden: Melæna, hæmatemese, stomatitis, esophagitis, gastroesofageal refluks, dysfagi, aftøs stomatitis, glossitis, peptisk ulceration med perforation.
English: Lornoxicam caused renal toxicity and gastrointestinal ulceration single- and repeat-dose toxicity studies in several species.
Danish: I flere arter har lornoxicam i toksikologiske enkel- og flerdosisstudier medført renal toksicitet og gastrointestinal ulceration.
English: Therapeutic indications - Section 4.1 of the SPC The Therapeutic Indications were agreed for the following pharmaceutical forms and strengths of lornoxicam
Danish: Der blev fastlagt følgende terapeutiske indikationer for de forskellige lægemiddelformer og styrker af lornoxicam:
English: 6.3 Shelf life 5 years
Danish: 6.3 Opbevaringstid 5 år.
English: General disorders and administrative site conditions Uncommon: Malaise, face oedema.
Danish: Almene symptomer og reaktioner på administrationsstedet Ikke almindelig: Utilpashed, ansigtsødemer.
English: Driving and using machines Xefo Rapid has no or negligible influence on the ability to drive or use machinery.
Danish: Xefo Rapid påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj eller betjene maskiner.
English: Serious Adverse Drug Reactions
Danish: Alvorlige bivirkninger
English: As with most NSAIDs occasional increase in serum transaminases level, increase in serum bilirubin or other liver function parameters, as well as increases in serum creatinine and blood urea nitrogen as well as other laboratory abnormalities have been reported.
Danish: Som med de fleste NSAID er der lejlighedsvis set stigning i serumtransaminase, stigning i serumbilirubin eller andre leverfunktionsparametre, ligesom stigning i serumkreatinin og -urinstof såvel som andre afvigende laboratoriefund.
English: In addition the following wording has been included as agreed by the PhVWP in October 2005 and January 2007: - History of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy - Active or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding) - Severe heart failure
Danish: Derudover er indsat følgende ordlyd, som blev vedtaget af PhVWP i oktober 2005 og januar 2007: - Tidligere gastrointestinal blødning eller perforation i forbindelse med tidligere behandling med
English: SUMMARY OF PRODUCT CHARACTERISTICS
Danish: Anbefalingerne i produktresuméet
English: 5.1 Pharmacodynamic properties
Danish: 5.1Farmakodynamiske egenskaber
English: When GI bleeding or ulceration occurs in patients receiving lornoxicam, the treatment should be withdrawn.
Danish: Hvis, der opstår gastrointestinal blødning eller ulceration opstår hos patienter i behandling med lornoxicam, skal behandlingen seponeres.
English: What Xefo Rapid is and what it is used for Before you take Xefo Rapid How to take Xefo Rapid Possible side effects
Danish: Xefo Rapids virkning og hvad det skal bruges til Det skal du vide, før du begynder at tage Xefo Rapid Sådan skal du tage Xefo Rapid Bivirkninger
English: Peptic ulcers, perforation or GI bleeding, sometimes fatal, particularly in the elderly, may occur (see section 4.4).
Danish: Peptiske ulcera, perforation eller GI blødning, som kan være fatal specielt for ældre, kan forekomme (se pkt.
English: Always take Xefo Rapid exactly as your doctor has told you.
Danish: Tag altid Xefo Rapid nøjagtigt efter lægens anvisning.
English: Xefo Rapid is not recommended for use in children and adolescents below age 18 due to lack of data
Danish: Xefo Rapid anbefales ikke til behandling af børn og unge under 18 år på grund af manglende data.
English: The mean elimination half-life of the parent compound is 3 to 4 hours.
Danish: Den gennemsnitlige eliminationshalveringstid er 3 til 4 timer.
English: During combined treatment renal function should be monitored.
Danish: Ved kombinationsbehandling skal nyrefunktionen monitoreres.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One film-coated tablet contains 4 mg lornoxicam Excipients: Lactose 94 mg
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING 1filmovertrukken tablet indeholder 4 mg lornoxicam Indeholder: Laktose 94 mg
English: Renal function must therefore be monitored closely in patients receiving combination therapy.
Danish: Hos patienter i kombinationsbehandling skal nyrefunktionen derfor monitoreres nøje.
English: Amber glass, class III (hydrolytic) with aluminium screw cap closures.
Danish: Primær emballage: Brune glas, klasse III (hydrolytisk) med sølvfarvet aluminium skruelåg.
English: 3 years
Danish: -9. måned
English: Powder: Mannitol, Trometamol, Disodium edetate
Danish: Mannitol,trometamol, dinatriumedetat Solvens:
English: Therefore lornoxicam should not be used in breastfeeding women.
Danish: Lornoxicam bør derfor ikke bruges til kvinder, der planlægger at blive gravide.
English: Xefo is not recommended for use in children and adolescents below age 18 due to lack of data.
Danish: Xefo anbefales ikke til behandling af børn og unge under 18 år på grund af manglende data.
English: What Xefo is and what it is used for Before you take Xefo How to take Xefo
Danish: Xefos virkning og hvad det skal bruges til Det skal du vide, før du begynder at tage Xefo Sådan skal du tage Xefo Bivirkninger
English: Uncommon: Constipation, flatulence, eructation, dry mouth, gastritis, gastric ulcer, abdominal pain upper, duodenal ulcer, mouth ulceration.
Danish: Ikke almindelig: Obstipation, flatulens, ræben, mundtørhed, gastritis, mavesår, øvre abdominalsmerter, duodenale ulcera, ulceration i munden.
English: Always take Xefo exactly as your doctor has told you.
Danish: Tag altid Xefo nøjagtigt efter lægens anvisning.
English: Lornoxicam 8mg bid is at least as effective as diclofenac 50mg tid and naproxen 500mg bid.
Danish: Lornoxicam, 8 mg to gange dagligt, er mindst lige så effektivt som diclofenac, 50 mg tre gange dagligt, eller naproxen, 500 mg to gange dagligt.
English: Common: Nausea, abdominal pain, dyspepsia, diarrhoea, vomiting.
Danish: Almindelig: Kvalme, abdominalsmerter, dyspepsi, diaré; opkastning.
English: 6.4 Special precautions for storage Do not store above 25°C.
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Må ikke opbevares over 25 °C.
English: What Xefo 4 mg/ml solution for injection contains The vial: - The active substance is lornoxicam.
Danish: Xefo 4 mg/ml, pulver og solvens til injektionsvæske, opløsning indeholder: Hætteglas: Det aktive indholdsstof er lornoxicam.
English: Thus meta-analysis 3 does not essentially contribute to the MAH's claim for an unrestricted use of lornoxicam in the treatment of pain.
Danish: Metaanalyse 3 bidrager således ikke væsentligt til den af indehaveren af markedsføringstilladelsen ansøgte uindskrænkede smerteindikation.
English: The use of Xefo may impair fertility and is not recommended in women attempting to conceive.
Danish: Xefo kan nedsætte evnen til at blive gravid, og Xefo bør derfor ikke gives til kvinder, der forsøger at blive gravide.
English: This leaflet was last approved in {MM/YYYY}.
Danish: Denne indlægsseddel blev senest revideret MM/ÅÅÅÅ
English: In addition, increased incidences of various malformations, including cardiovascular, have been reported in animals given a prostaglandin synthesis inhibitor during the organogenetic period.
Danish: Yderligere er der i dyr, der har fået prostaglandinsyntesehæmmere i den organogenetiske periode, set forhøjet forekomst af forskellige misdannelser, også kardiovaskulære.
English: If you experience any unusual abdominal symptoms such as abdominal bleeding, skin reactions such as skin rash, mucosal lesions or other signs of hypersensitivity, you should stop taking Xefo Rapid and contact you doctor immediately.
Danish: Hvis du oplever unormale mavesymptomer som f.eks. maveblødninger, hudreaktioner i form af udslæt, slimhindeforandringer eller andre tegn på overfølsomhed, skal du stoppe behandlingen med Xefo og straks kontakte din læge.
English: One vial powder for solution for injection One ampoule solvent for solution for injection
Danish: 1 hætteglas pulver til injektionsvæske, opløsning 1 ampul solvens til injektionsvæske, opløsning
English: In women who have difficulties conceiving or who are undergoing investigation of infertility, withdrawal of lornoxicam should be considered.
Danish: Hos kvinder, som har vanskeligt ved at blive gravide, eller som bliver undersøgt for infertilitet, bør seponering af lornoxicam overvejes.
English: The elderly have an increased frequency of adverse reactions to NSAIDs especially gastrointestinal bleeding and perforation which may be fatal (see section 4.3).
Danish: Ældre i behandling med NSAID-præparater har en øget risiko for at få bivirkninger især gastrointestinal blødning og -perforation, som kan være fatal (se pkt.
English: In a clinical study in patients with pain after surgical removal of an impacted third molar lornoxicam Rapid film-coated tablets showed a faster onset of action compared to lornoxicam film-coated tablets.
Danish: I et klinisk forsøg med patienter med smerter efter dentalkirurgi har Xefo Rapid filmovertrukne tabletter vist en hurtigere indtrædende virkning (hurtigere lindring) end ved behandling med Xefo tabletter.
English: Lornoxicam should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.
Danish: Behandling med lornoxicam bør straks seponeres ved symptomer som udslæt, slimhindelæsioner eller anden overfølsomhedsreaktion.
English: Nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease (see section 4.4) have been reported following administration of NSAIDs.
Danish: Kvalme, opkastning, diaré, flatulens, forstoppelse, dyspepsi, abdominale smerter, melæna, haematemesis, ulcerativ stomatit, forværring af colitis og Crohns sygdom (se pkt.
English: - Symptomatic relief of pain and inflammation in rheumatoid arthritis
Danish: - Symptomatisk lindring af smerter og inflammation ved reumatoid artritis.
English: 6.6 Special precautions for disposal and other handling The solution for injection is prepared by dissolving the content of one vial in water for injection from the accompanying ampoule, immediately prior to use.
Danish: Opløsningen til injektion fremstilles umiddelbart før brug ved at opløse indholdet af hætteglasset i væsken fra den medfølgende ampul.
English: Incidence of ADRs reported for lornoxicam by SOC, Indication and Dose
Danish: Tabel Incidensen af bivirkninger af lornoxicam, fordelt på systemorganklasser, indikationer og doser
English: With respect to OA, the following can be summarised: Lornoxicam 8mg bid (16 mg) is more efficacious than placebo.
Danish: Lornoxicam, 8 mg to gange dagligt (16 mg), er mere effektivt end placebo.
English: Xefo tablets must be swallowed with sufficient fluid.
Danish: Tabletterne bør indtages med tilstrækkelig mængde væske.
English: Lornoxicam 4mg tid or 8mg bid is at least as effective as diclofenac 50mg tid and naproxen 500mg bid.
Danish: Lornoxicam, 4 mg tre gange dagligt og 8 mg to gange dagligt, er mindst lige så effektivt som diclofenac, 50 mg tre gange dagligt, eller naproxen, 500 mg to gange dagligt.
English: - Other NSAIDs: Increased risk of gastrointestinal bleeding.
Danish: 4.4) - andre NSAID-præparater medfører øget risiko for gastrointestinal blødning.
English: What Xefo Rapid looks like and contents of the pack Xefo Rapid 8 mg film-coated tablet is a white to yellowish round biconvex film-coated tablet.
Danish: Xefo Rapids udseende og pakningstørrelse Xefo Rapid 8 mg filmovertrukne tabletter er en hvid til gullig, rund, hvælvet filmovertrukken tablet.
English: Lornoxicam, 4 & 8 mg, film-coated tablets 8-16 mg lornoxicam daily divided into 2 or 3 doses.
Danish: Lornoxicam, filmovertrukne tabletter, 4 mg og 8 mg 8-16 mg dagligt, fordelt på to eller tre doser.
English: Tablet container: This medicinal product does not require any special storage conditions
Danish: Glas: Dette lægemiddel kræver ingen særlige forholdsregler vedrørende opbevaringen
English: (The pharmacokinetic profile of a single dose of 8 mg lornoxicam i.m.
Danish: (En enkelt im injektion af 8 mg lornoxicam har samme farmakokinetiske profil som en oral dosis på 8 mg lornoxicam med hurtig udløsning).
English: Preclinical safety data - Section 5.3 The divergences between the MS have been harmonised.
Danish: 5.3 Divergenserne mellem medlemsstaterne er bragt ud af verden.
English: Lornoxicam, 8 mg, Powder and solvent for solution for injection Recommended dose: 8 mg intravenous or intramuscular.
Danish: Lornoxicam, pulver og solvens til injektionsvæske, opløsning, 8 mg Anbefalet dosis: 8 mg iv eller im.
English: From clinical trial data there is no evidence of accumulation of lornoxicam after repeated administrations, when given according to recommended dosage.
Danish: Når lornoxicam gives i anbefalede doser viser data fra kliniske undersøgelser ikke tegn på akkumulation af lornoxicam efter gentagne administrationer.
English: the CHMP has recommended the amendment of the Marketing Authorisation(s) for which the Summary of Product Characteristics, labelling and package leaflet are set out in Annex III for Xefo and associated names (see Annex I).
Danish: Ud fra følgende betragtninger: - indbringelsen vedrørte harmoniseringen af produktresuméerne, etiketteringen og indlægssedlen - det produktresumé og den etikettering og indlægsseddel, der søges godkendt af indehaveren af markedsføringstilladelsen, blev vurderet på grundlag af den forelagte dokumentation og de faglige drøftelse i udvalgetanbefalede CHMP ændring af de markedsføringstilladelser, for hvilke produktresumé, etikettering og indlægsseddel fremgår af bilag III for Xefo og tilknyttede navne (se bilag I).
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER [See Annex I - To be completed nationally] {Name and address} <{tel}> <{fax}> <{e-mail}>
Danish: INDEHAVER AF MARKEDSFØRINGSTILLADELSEN <[Se bilag I - Udfyldes nationalt]> {Navn og adresse} <{tlf}> <{fax}> <{email}>
English: Pack sizes: 10, 20, 30, 50 and 100 film-coated tablets.
Danish: Pakningsstørrelser: 10, 20, 30, 50 og 100 filmovertrukne tabletter.
English: Xefo Rapid should not be taken during the first six months of pregnancy and by breast-feeding women.
Danish: Xefo Rapidbør ikke tages i de første 6 måneder af graviditeten, eller hvis du ammer.
English: Oedema, hypertension, and cardiac failure, have been reported in association with NSAID treatment.
Danish: Ødemer, hypertension og hjertesvigt er rapporteret i forbindelse med NSAID behandling.
English: Driving and using machines Xefo has no or negligible influence on the ability to drive or use machinery.
Danish: Trafik- og arbejdssikkerhed Xefo påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj eller betjene maskiner.
English: The route of administration is intravenous (IV) or intramuscular injection (IM).
Danish: Administrationsvejen er intravenøs (i.v.)
English: Xefo should not be taken during the first six months of pregnancy and by breast-feeding women.
Danish: Xefo bør ikke tages i de første 6 måneder af graviditeten, eller hvis du ammer.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION [To be completed nationally]
Danish: DATO FOR FØRSTE MARKEDFØRINGSTILLADELSE/FORNYELSE AF
English: Xefo Rapid is distributed in pack sizes of 6, 10, 20, 30, 50, 100 and 250 film-coated tablets.
Danish: Xefo Rapid findes i pakningsstørrelser à 6, 10, 20, 30, 50, 100 og 250 filmovertrukne tabletter.
English: Due to genetic polymorphism, slow and extensive metabolisers exist for this enzyme which could result in markedly increased plasma levels of lornoxicam in slow metabolisers.
Danish: Hos patienter med langsom metabolisering, kan dette forårsage væsentligt højere plasmakoncentrationer af lornoxicam.
English: A clear reduction in pain intensity vs. placebo was only obtained at ≥8 mg LNX p.o. (8
Danish: Kun doser ≥8 mg oralt gav klart mindre smerteintensitet end placebo (8 mg dosen i undersøgelse CT01).
English: Lornoxicam reduces platelet aggregation and prolongs bleeding time and consequently care should be taken when administering to patients with increased bleeding tendency.
Danish: Lornoxicam skal administreres med forsigtighed til patienter med øget blødningstendens, da det kan hæmme trombocytaggregationen og forlænge blødningstiden.
English: Rare: Hypertension, hot flush, haemorrhage, haematoma.
Danish: Sjælden: Hypertension, hedeture, hæmoragi, hæmatom.
English: Lornoxicam, 8 mg, Powder and solvent for solution for injection Short-term relief of acute mild to moderate pain
Danish: Lornoxicam, pulver og solvens til injektionsvæske, opløsning, 8 mg Korttidsbehandling af akutte lette til moderate smerter
English: Renal and urinary disorders Rare: Nocturia, micturition disorders, increase in blood urea nitrogen and creatinine levels.
Danish: Nyrer og urinveje Sjælden: Nykturi, vandladningsforstyrrelser, øget urinstof- og kreatininkoncentration i blodet.
English: Blood and the lymphatic system disorders Rare: Anaemia, thrombocytopenia, leucopoenia, prolonged bleeding time Very rare: Ecchymosis.
Danish: Sjælden: Anæmi, thrombocytopeni, leukopeni, forlænget blødningstid Meget sjælden: Ekkymose.
English: PHARMACEUTICAL FORM Film-coated tablet
Danish: Filmovertrukken tablet
English: Acute pain
Danish: Akut smerte
English: Romania
Danish: Rumanien