FrancophonIA/ELRC3.0 huggingface dataset:
English: As for all NSAIDs, gastro-intestinal (GI) events were the most frequent (14%) followed by central nervous system (CNS), Peripheral nervous system (PNS), Psychiatric (Psych) (6%), Other (2%), Whole body (2%) and Skin (1%).
Danish: Som for alle NSAID var gastrointestinale bivirkninger de hyppigste (14 %) efterfulgt af CNS, PNS, psykiske (6 %), andre (2 %), generaliserede (2 %) og hud (1 %).
English: The classic rheumatology disorders were investigated in 26 studies with 3,621 patients: 12 studies in rheumatoid arthritis (RA), 8 studies in osteoarthritis (OA), 3 in both indications and 3 in other rheumatology indications (i.e. ankylosing spondylitis (AKS), non-arthritic rheumatism and acute gout).
Danish: De klassiske reumatiske sygdomme var genstand for 26 undersøgelser med 3 621 patienter: Tolv undersøgelser i reumatoid artritis (RA), otte undersøgelser i osteoartritis (OA), tre i begge indikationer og tre i andre reumatiske indikationer (ankyloserende spondylitis, ikke-artikulære reumatiske lidelser og akut arthritis urica).
English: The submitted efficacy data on pain focus on meta-analyses from 12 placebo-controlled pain studies (including partly also active controls) [See Table below].
Danish: De fremlagte virkningsdata om smerter bygger på metaanalyser af 12 placebokontrollerede smerteundersøgelser (også inklusive aktive kontroller) (se nedenstående tabel).
English: The injection should be administered slowly over not less than 15 seconds as an i.v.
Danish: Injektionen bør gives langsomt over mindst 15 sekunder i.v.
English: 4 of 7 studies investigated the efficacy in third molar surgery pain (and three of these studies were already included in meta-analysis
Danish: Fire af de syv undersøgelser vedrørte virkningen mod postoperative smerter ved indgreb på tredje molar (og tre af disse undersøgelser var i forvejen medtaget i metaanalyse 1).
English: The aim of the overall analysis (meta-analysis) was to compare the efficacy of different dosages of lornoxicam with comparator drugs or placebo, in a cohort of RA patients.
Danish: Formålet med den samlede analyse (metaanalyse) var at sammenligne virkningen af forskellige doser af lornoxicam med virkningen af sammenligningspræparater eller placebo hos en kohorte af patienter med RA.
English: Therefore, the use of lornoxicam is contraindicated during the third trimester of pregnancy (see section 4.3).
Danish: Derfor er brugen af lornoxicam kontraindiceret i tredje trimester af graviditeten (se pkt.
English: Maximum plasma concentrations are achieved after approximately 30 minutes.
Danish: Den maksimale plasmakoncentration opnås efter ca. 30 minutter.
English: Recommended dose: 8 mg intravenous or intramuscular.
Danish: Anbefalet dosis: 8 mg intravenøst eller intramusculær.
English: Treatment of rheumatoid arthritis has been approved by 16/16 Member States (AT, BE, CZ, DE, DK, EE, ES, GR, HU, IT, LT, LV, PT, SE, UK).
Danish: Behandling af reumatoid artritis er godkendt i 16/16 medlemsstater (AT, BE, CZ, DE, DK, EE, ES, GR, HU, IT, LT, LV, PT, SE, UK).
English: 4.5 Interaction with other medicinal products and other forms of interaction Concomitant administration of lornoxicam and - Cimetidine: Increased plasma concentrations of lornoxicam.
Danish: 4.5 Interaktion med andre lægemidler og andre former for interaktion Samtidig behandling med lornoxicam og - cimetidin: medfører højere plasmakoncentrationer af lornoxicam.
English: In elderly patients above age 65, the clearance is reduced with 30-40%.
Danish: Clearance er reduceret med 30 - 40 % hos patienter over 65 år.
English: Therapeutic indication - pain
Danish: Terapeutisk indikation - smerter
English: BATCH NUMBER
Danish: BATCHNUMMER Batchnr.
English: Film:
Danish: Filmovertræk:
English: Therapeutic indication - osteoarthritis (OA)
Danish: Terapeutisk indikation - osteoartritis (OA)
English: The analgesic properties of lornoxicam have been demonstrated successfully in several clinical trials during development of the drug.
Danish: Lornoxicams analgetiske egenskaber er blevet påvist i flere kliniske forsøg under udviklingen af lægemidlet.
English: Data from 103 clinical studies were included in the SDB including 57 double-blind studies, 4 singleblind studies and 50 open studies of which 8 were follow-up to randomised studies.
Danish: I sikkerhedsdatabasen indgik data fra 103 kliniske undersøgelser, hvoraf 57 var dobbeltblindundersøgelser, 4 var enkeltblindundersøgelser, og 50 var åbne undersøgelser, af hvilke 8 var opfølgninger på randomiserede undersøgelser.
English: injection use sufficiently long needle for a deep intramuscular injection.
Danish: injektion vælges en tilstrækkelig lang kanyle til en dyb intramuskulær injektion.
English: Ear and labyrinth disorders Uncommon: Vertigo, tinnitus.
Danish: Øre og labyrint Ikke almindelig: Vertigo, tinnitus.
English: The second meta-analysis included seven studies (CT01, CT02, CT03, CT14, CT32, CT78 and CT85) with orally applied lornoxicam including a total of 1581 patients.
Danish: Den anden metaanalyse omfattede syv undersøgelser (CT01, CT02, CT03, CT14, CT32, CT78 og CT85) med oralt lornoxicam og i alt 1581 patienter.
English: There are insufficient data to exclude such a risk for lornoxicam.
Danish: De foreliggende data er ikke tilstrækkelige til at udelukke en sådan risiko for lornoxicam.
English: Studies not investigating the recommended doses of either 4 mg tid or 8 mg bid were excluded from the analysis.
Danish: Undersøgelser, der ikke omfattede de anbefalede doser på enten 4 mg tre gange dagligt eller 8 mg to gange dagligt, blev udelukket af analysen.
English: Osteoarthritis and Rheumatoid arthritis
Danish: Osteoarthritis og reumatoid arthritis
English: In rabbit and rat, lornoxicam caused premature closure of the ductus arteriosus due to inhibition of cyclooxygenase.
Danish: I kaniner og rotter medfører lornoxicam en præmatur lukning af ductus arteriosus pga. hæmning af cyclooxygenase.
English: Metabolic/Endocrine
Danish: Metaboliske/endokrine Luftveje
English: It increased by duration of treatment (0.3%, 0.5% and 1.9% for short-, medium- and long-term treatment, respectively) and was influenced by the vulnerability of patients with chronic diseases in long-term treatment: The majority of patients with SADR had RA or were elderly patients included in post-operative pain studies such as hip replacement.
Danish: Hyppigheden steg med stigende behandlingsvarighed (0,3 %, 0,5 % og 1,9 % for henholdsvis kortvarig, mellemlang og langvarig behandling) og blev påvirket af følsomheden hos de kroniske patienter i langtidsbehandling: Af patienter med alvorlige bivirkninger havde størstedelen RA eller var ældre patienter, der indgik i undersøgelser af postoperative smerter efter f.eks. hofteoperationer.
English: As outlined by the MAH this meta-analysis was restricted to placebo-controlled studies as the purpose of the analysis was to estimate a difference to placebo [Tab.
Danish: Som det fremgår af redegørelsen fra indehaveren af markedsføringstilladelsen, var metaanalysen begrænset til de placebokontrollerede undersøgelser, da analysens formål var at beregne et estimat for forskellen fra placebo (tabel 4).
English: - Elderly patients above 65 years: Monitoring of renal and hepatic function is recommended.
Danish: - Ældre (over 65 år): Det anbefales at monitorere nyre- og leverfunktionen.
English: Although a considerable number of patients have been treated with lornoxicam so far, only few of the known serious reactions to other NSAIDs have been reported for lornoxicam.
Danish: Skønt der indtil nu er behandlet et betydeligt antal patienter med lornoxicam, er der kun indberettet få af de alvorlige bivirkninger, som kendes fra andre NSAID.
English: The MAH has applied the PhVWP core information for NSAIDs in relation to gastrointestinal safety, skin reactions and cardiovascular safety (October 2005).
Danish: Indehaveren af markedsføringstilladelsen har anvendt kerneoplysningerne fra PhVWP vedrørende NSAID i forbindelse med gastrointestinal sikkerhed, hudreaktioner og kardiovaskulær sikkerhed (oktober 2005).
English: Rare: Dermatitis, purpura.
Danish: Sjælden: Dermatitis, pupura.
English: Lornoxicam is contraindicated on the third trimester of pregnancy and should not be used during pregnancy in the first and second trimesters and delivery as no clinical data on exposed pregnancies are available.
Danish: Lornoxicam er kontraindiceret i tredje trimester og bør ikke anvendes i første og andet trimester eller ved fødslen, da kliniske oplysninger om eksponerede graviditeter savnes.
English: The plasma protein binding of lornoxicam is 99 % and not concentration dependent.
Danish: Plasmaproteinbindingen er 99 %, og er ikke-koncentrationsafhængig.
English: Lornoxicam has no effect on vital signs (e.g. body temperature, respiratory rate, heart rate, blood pressure, ECG, spirometry).
Danish: Lornoxicam påvirker ikke legemsfunktioner (f.eks. kropstemperatur, respirationsfrekvens, hjertefrekvens, blodtryk, EKG, spirometri).
English: Intravenous use Intramuscular use
Danish: Intravenøs brug Intramuskulær brug
English: - Patients with blood coagulation disorders: Careful clinical monitoring and laboratory assessment is recommended (e.g. APTT).
Danish: - Patienter med koagulationsforstyrrelser: Det anbefales at følge patienten nøje og udføre laboratorieundersøgelser (f.eks. APTT).
English: Study CT85 used only a single oral dose of 8 mg LNX p.o.
Danish: I undersøgelse CT85 blev der kun anvendt en oral enkeltdosis på 8 mg.
English: Rare: Hepatic function abnormal.
Danish: Sjælden: Abnorm leverfunktion.
English: No data are available on simultaneous intake of Xefo Rapid film-coated tablets with meals, but based on data for Xefo film-coated tablets a reduction of Cmax, an increase in Tmax, and a reduction in the absorption (AUC) of lornoxicam may be expected.
Danish: Der er ikke tilgængelige data for indtagelse af Xefo Rapid filmovertrukne tabletter samtidig med et måltid, men baseret på data for Xefo filmovertrukne tabletter må det forventes at Cmax reduceres, Tmax forøges, og absorptionen af lornoxicam (beregnet på AUC) reduceres.
English: Three of the lornoxicam patients participated in a study investigating the efficacy of lornoxicam in pain due to bone metastases in prostate cancer, which was the cause of death for two.
Danish: Tre af lornoxicam-patienterne deltog i en undersøgelse af virkningen af lornoxicam mod smerter fra knoglemetastaser ved prostatacancer, som var dødsårsag i to tilfælde.
English: The chemical and physical in-use stability has been demonstrated for 24 hours at 21 °C (±2°C).
Danish: De kemiske og fysiske stabilitetskrav holder i 24 timer ved 21ºC (± 2ºC ).
English: Keep vial in the outer carton.
Danish: Opbevar hætteglasset i den ydre karton.
English: Overall discussion on the meta-analyses
Danish: Samlet gennemgang af metaanalyserne
English: Uncommon: Increase in liver function tests, SGPT (ALT) or SGOT (AST).
Danish: Ikke almindelig: Forhøjede levertal SGPT (ALT) eller SGOT (AST).
English: - Sulphonylureas: Increased risk of hypoglycaemia.
Danish: - sulfonylurinstoffer: medfører forøget risiko for hypoglykæmi.
English: If the solution is not used immediately, in-use storage times and conditions prior to use is the responsibility of the user and would not be longer than 24 hours at 2-8 °C taken place in controlled and validated aseptic condition.
Danish: Hvis opløsningen ikke bruges straks, er holdbarheden brugerens ansvar, og den vil ikke være mere end 24 timer ved 28 ºC under kontrollerede og validerede aseptiske forhold.
English: The safety database (SDB) included all lornoxicam studies under the control of Nycomed Pharma (studies performed by third parties were excluded) comprised a total of 12,570 patients of who 7,427 received lornoxicam.
Danish: Sikkerhedsdatabase, antal patienter og eksponering Sikkerhedsdatabasen omfattede alle de undersøgelser, der blev forestået af Nycomed Pharma (undersøgelser udført af tredjeparter var udelukket) med i alt 12 570 patienter, hvoraf 7 427 fik lornoxicam.
English: 4.2 Posology and method of administration For all patients the appropriate dosing regimen should be based upon individual response to treatment.
Danish: 4.2 Dosering og indgivelsesmåde Generelt bør dosis fastlægges ud fra den enkelte patients respons på behandling.
English: The absolute bioavailability of Xefo Rapid film-coated tablets is 90-100 % which is equivalent to Xefo film-coated tablet.
Danish: Den absolutte biotilgængelighed af Xefo Rapid filmovertrukne tabletter er 90-100 %, hvilket er ækvivalent med Xefo filmovertrukne tabletter.
English: The Cmax for Xefo Rapid filmcoated tablets is higher than Cmax for Xefo film-coated tablets and equivalent to Cmax for the parenteral formulation of lornoxicam.
Danish: Cmax for Xefo Rapid filmovertrukne tabletter er højere end Cmax for Xefo filmovertrukne tabletter og ækvivalent med Cmax for den parenterale formulering af lornoxicam.
English: There are no adequate data from the use of lornoxicam in pregnant women.
Danish: Der er ikke tilstrækkelig data om brugen af lornoxicam hos gravide.
English: At this time, there is no experience of overdose to permit definition of the consequence of an overdose, or to suggest specific managements.
Danish: Dermed kan konsekvensen af en overdosis ikke defineres, og en specifik behandling kan heller ikke foreslås.
English: In addition, the use of the endpoint overall impression, which was used as a secondary endpoint in all studies in meta-analysis 3 can not convincingly support the MAH approach for a general indication for pain relief.
Danish: Desuden kan brugen af endepunktet helhedsindtryk, der er brugt som sekundært endepunkt i alle undersøgelserne i metaanalyse 3, ikke overbevisende underbygge den generelle smerteindikation som tilsigtet af indehaveren af markedsføringstilladelsen.
English: The Table below shows the percentages of patients with ADRs in order of incidence by system organ classification (SOC, WHO), lornoxicam dose and indication.
Danish: Nedenstående tabel viser den procentdel af patienterne, der havde bivirkninger, ordnet efter hyppighed og fordelt på organklassifikation (SOC, WHO), lornoxicam-dosis og indikation.
English: For all the pharmaceutical forms and strengths of lornoxicam It was agreed that the following would be included: - Methotrexate: Increased serum concentration of methotrexate.
Danish: For samtlige lægemiddelformer og styrker af lornoxicam gælder følgende: Det blev vedtaget at indsætte følgende tekst: - Methotrexat: Kan øge serumkoncentrationen af methotrexat.
English: After IM injection, maximum plasma concentrations are achieved after approximately 0.4 hours.
Danish: injektion opnås maksimal plasmakoncentration efter ca. 0,4 timer.
English: No special dosage modification is required for elderly patients above age 65 unless renal or hepatic function is impaired.
Danish: Det er ikke nødvendigt at justere dosis til ældre over 65 år, med mindre deres nyre- eller leverfunktion er nedsat.
English: Oral use
Danish: Til oral brug
English: The mean elimination half-life is 3-4 hours.
Danish: Den gennemsnitlige elimineringshalveringstid er 3-4 timer.
English: For this reason a new metaanalysis 3 with the p.o. data alone will not add much to the discussion.
Danish: En ny metaanalyse 3, der kun omfatter peroral administration, vil derfor ikke tilføre diskussionen meget nyt.
English: Treatment of osteoarthritis has been approved by 14/16 Member States (AT, BE, CZ, DE, DK, ES, GR, HU, LT, LV, PT, SE, UK).
Danish: Behandling af reumatoid artritis er godkendt i 14 af 16 medlemsstater (AT, BE, CZ, DE, DK, EE, ES, GR, HU, IT, LT, LV, PT, SE, UK).
English: Low 8mg 12mg 16mg High Total Low 8mg 12mg 16mg High TotalTotal
Danish: Lav 8 mg 12 mg 16 mg Høj
English: 6.3 Shelf life 2 years.
Danish: 6.3 Opbevaringstid 2 år.
English: DATE OF REVISION OF THE TEXT [To be completed nationally]
Danish: DATO FOR ÆNDRING AF TEKSTEN <[Udfyldes nationalt]>
English: Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or the embryo/foetal development.
Danish: Hæmning af prostaglandinsyntesen kan have skadelig indvirkning på graviditeten og/eller den embryonale/føtale udvikling.
English: Psychiatric disorders Uncommon: Insomnia, depression.
Danish: Psykiske forstyrrelser Ikke almindelig: Søvnløshed, depression.
English: For i.m.
Danish: Ved i.m.
English: Reactions of liver and haematology have all been mild.
Danish: De hepatiske og hæmatologiske reaktioner har alle været af lettere art.
English: The absolute bioavailability (calculated on AUC) after IM administration is 97 %
Danish: Den absolutte biotilgængelighed (beregnet på AUC) efter i.m.
English: Maximum plasma concentrations are achieved after approximately 1-2 hours.
Danish: Den maksimale plasmakoncentration opnås efter ca. 1 - 2 timer.
English: Similar consideration should be made before initiating longer-term treatment of patients with risk factors for cardiovascular disease (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking).
Danish: Tilsvarende overvejelser bør finde sted før initiering af langtidsbehandling af patienter med risikofaktorer for kardiovaskulær sygdom (f.eks. hypertension, hyperlipidæmi, diabetes mellitus eller rygning).
English: - Quinolone antibiotics: Increased risk of seizures.
Danish: - quinolonantibiotika: medfører øget risiko for krampeanfald.
English: The meta-analysis included only 3 studies on third molar surgery (CT01, CT14, CT78) with orally applied lornoxicam.
Danish: Metaanalysen omfattede kun tre undersøgelser vedrørende operative indgreb på tredje molar (CT01, CT14, CT78) med oralt indgivet lornoxicam.
English: Like all medicines, Xefo can cause side effects, although not everybody gets them.
Danish: Xefo kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: 4.7 Effects on ability to drive and use machines Patients showing dizziness and/or sleepiness under treatment with lornoxicam should refrain from driving or operation machinery.
Danish: 4.7 Virkning på evnen til at føre motorkøretøj eller betjene maskiner Patienter, som oplever svimmelhed og/eller træthed under behandling med lornoxicam, bør afholde sig fra at føre motorkøretøj eller betjene maskiner.
English: - Anti-coagulants: NSAIDs may enhance the effects of anti-coagulants, such as warfarin (see section 4.4).
Danish: - antikoagulantia: kan forstærke effekten af antikoagulantia, såsom warfarin (se pkt.
English: Pack sizes: 250 and 500 film-coated tablets.
Danish: Pakningsstørrelser: 250 og 500 filmovertrukne tabletter.
English: Data from epidemiological studies suggest an increased risk of miscarriage and of cardiac malformation after use of a prostaglandin synthesis inhibitor in early pregnancy.
Danish: Data fra epidemiologiske studier tyder på en øget risiko for spontan abort og for hjertemisdannelser ved brug af prostaglandinsyntesehæmmere i den tidlige graviditet.
English: You must not take Xefo during the last three months of your pregnancy.
Danish: Du må ikke tage Xefo i de sidste 3 måneder af graviditeten..
English: Therefore serum lithium levels require monitoring, especially during initiation, adjustment and withdrawal of treatment.
Danish: Serumlitium kræver derfor overvågning, navnlig når behandlingen indledes, justeres eller seponeres.
English: Meta-analysis 3:
Danish: Metaanalyse 3:
English: At the end of pregnancy, prostaglandin synthesis inhibitors may expose the mother and the foetus to increased bleeding time and inhibition of uterine contractions, which may delay or prolong the labour.
Danish: Ved graviditetens slutning kan prostaglandinsyntesehæmmere udsætte moderen og fosteret for forlænget blødningstid og hæmning af livmoderkontraktioner, hvilket kan forsinke eller forlænge fødselsveerne.
English: Table
Danish: Tabel
English: For several drugs causing interaction and which possibly increase the risk of toxicity in combination with NSAIDs/lornoxicam, the recommendation regarding drug monitoring (for methotrexate, lithium and cyclosporine) has been included in the SPC.
Danish: For visse lægemidler, der medfører interaktion og muligvis øget risiko for toksicitet sammen med NSAID/lornoxicam, er der i produktresuméet indsat en anbefaling om lægemiddelovervågning (dette gælder methotrexat, litium og cyclosporin) .
English: - Diuretics: Decreased diuretic and antihypertensive effect of loop diuretics and thiazide diuretics.
Danish: - diuretika: medfører nedsat diuretisk og antihypertensiv virkning af loop-diuretika og thiaziddiuretika.
English: Cellulose, microcrystalline Sodium hydrogen carbonate Calcium hydrogen phosphate, anhydrous Low substituted hydroxypropylcellulose Hydroxypropylcellulose Calcium stearate
Danish: Mikrokrystallinsk cellulose Natriumhydrogencarbonat Calciumhydrogenphosphat, vandfri Lavt substitueret hydroxypropylcellulose Hydroxypropylcellulose Calciumstearat
English: Study CTX 87 was excluded since single doses of 4-20 mg LNX were administered i.m.
Danish: Undersøgelse CTX 87 blev udelukket, da den vedrørte anvendelse af enkeltdoser på 4-20 mg im.
English: Instruction for use and handling
Danish: INSTRUKTIONER VEDRØRENDE ANVENDELSEN
English: However, it can be expected that after an overdose with lornoxicam, the following symptoms can be seen: Nausea, vomiting, cerebral symptoms (dizziness, disturbances in vision).
Danish: Det kan dog forventes, at en overdosering med lornoxicam medfører følgende symptomer: Kvalme, opkastning, cerebrale symptomer (svimmelhed, synsforstyrrelser).
English: Lornoxicam is not dialysable.
Danish: Lornoxicam kan ikke fjernes ved dialyse.
English: Severe symptoms are ataxia ascending to coma and cramps, liver and kidney damages and maybe coagulation disorders.
Danish: Alvorligere symptomer er: ataksi stigende til koma og kramper, lever- og nyrerskader og muligvis koagulationsforstyrrelser.
English: Eleven studies with lornoxicam were performed in patients suffering from rheumatoid arthritis (RA) including nine controlled and 2 uncontrolled clinical phase II or III studies in RA patients.
Danish: Terapeutisk indikation - reumatiske smerter (RA) Hos patienter med reumatoid artritis (RA) er der udført 11 undersøgelser bestående af ni kontrollerede og to ukontrollerede kliniske fase II- eller III-undersøgelser .
English: - Cyclosporine: Increased serum concentration of cyclosporine.
Danish: - Cyclosporin: Øger serumkoncentration af cyclosporin.
English: Xefo 4 mg/ml solution for injection is intended for intramuscular (i.m.)
Danish: Xefo 4 mg/ml opløsning til injektion er beregnet til intramuskulær (i.m.)
English: In the literature, incidences of SADRs for NSAIDs vary between 0.3% and 4.7% indicating that the risk of developing SADRs with lornoxicam is similar to that of other NSAIDs.
Danish: I litteraturen varierer incidensen af alvorlige bivirkninger for NSAID mellem 0,3 % og 4,7 %, hvorfor lornoxicam må antages at medføre samme risiko for alvorlige bivirkninger som de øvrige NSAID.
English: The divergences between the MS in the wording of the description of the pharmacokinetic properties have been harmonised.
Danish: De divergenser mellem medlemsstaterne, der angår ordlyden af beskrivelsen af de farmakokinetiske egenskaber, er bragt ud af verden.
English: Concomitant treatment of NSAIDs and tacrolimus may increase the risk of nephrotoxicity owing to reduced synthesis of prostacyclin in the kidney.
Danish: Samtidig behandling med NSAID og tacrolimus kan øge risikoen for nefrotoksicitet grundet reduceret syntese af prostacyclin i nyrerne.
English: The divergences between the MS in the wording of the description of the pharmacodynamic properties have been harmonised.
Danish: De divergenser mellem medlemsstaterne, der vedrører ordlyden af beskrivelsen af de farmakodynamiske egenskaber, er bragt ud af verden.
English: For all the pharmaceutical forms and strengths of lornoxicam It was agreed that the following additional undesirable effects: weight changes, ecchymosis, prolonged bleeding time, bronchospasm, rhinitis, perforated peptic ulcer, pupura, increase in blood urea nitrogen and creatinine levels.
Danish: For samtlige lægemiddelformer og styrker af lornoxicam gælder følgende: Det blev vedtaget tilføje følgende bivirkninger: vægtændring, ekkymose, forlænget blødningstid, bronkospasmer, rhinitis, perforeret ulcus pepticum, purpura, forhøjet urea-, kvælstof- og kreatininindhold i blodet.