FrancophonIA/ELRC3.0 huggingface dataset:
English: In rat, lornoxicam impaired fertility (effects on ovulation and implantation), and affected the pregnancy and delivery.
Danish: Lornoxicam nedsætter fertiliteten (påvirker ovulation og implantation) og har indvirkning på graviditet og fødsel hos rotter.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS GLASS VIAL FOR LORNOXICAM POWDER
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ SMÅ INDRE PAKNINGER HÆTTEGLAS TIL LORNOXICAM PULVER
English: Special warnings and precautions for use - Section 4.4
Danish: Særlige advarsler og forsigtighedsregler vedrørende brugen - pkt.
English: Metabolism and nutrition disorders Uncommon: Anorexia, weight changes.
Danish: Metabolisme og ernæring Ikke almindelig: Anoreksi, vægtændringer.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucosegalactose malabsorption should not take this medicine.
Danish: Patienter med arvelig galactoseintolerans, en særlig form af hereditær lactasemangel (Lapp Lactase deficiency) eller glucose-/galactosemalabsorption, skal ikke tage denne medicin.
English: Meta-analysis 1
Danish: Metaanalyse 1
English: Pack sizes: 1, 5, 6, 10 sets.
Danish: Pakningsstørrelser: 1, 5, 6 , 10 sæt
English: Rare: Somnolence, paraesthesia, dysgeusia, tremor, migraine.
Danish: Sjælden: Somnolens, paræstesier, dysgeusia, tremor, migræne.
English: injection, and over not less than 5 seconds as i.m.
Danish: eller over mindst 5 sekunder som i.m.
English: Opaque PVC/Aluminium.
Danish: Primær emballage: Lystæt PVC/alufolie.
English: The most commonly observed adverse events of NSAIDs are gastrointestinal in nature.
Danish: De mest almindelige bivirkninger ved NSAID-præparater er af gastrointestinal oprindelse.
English: Respiratory, thoracic and mediastinal disorders Uncommon: Rhinitis.
Danish: Luftveje, thorax og mediastinum Ikke almindelig: Rhinitis.
English: - Lithium: NSAIDs inhibit renal clearance of lithium, thus the serum concentration of lithium may increase above toxicity limits.
Danish: - Litium: NSAID nedsætter den renale clearance af litium, hvorfor serumlitium kan overstige den toksiske grænseværdi.
English: Based on principles, only administering activated charcoal immediately after the intake of lornoxicam can lead to diminished absorption of the preparation.
Danish: Indgift af aktivt kul umiddelbart efter indtagelse af lornoxicam skulle teoretisk nedsætte absorptionen.
English: If you have heart problems, previous stroke or think that you might be at risk of theese conditions (for example if you have high blood pressure, diabetes or high cholesterol or are a smoker) you should discuss your treatment with your doctor or pharmacist.
Danish: Hvis du har problemer med hjertet, tidligere har haft slagtilfælde eller mener, at du har risiko for at få disse tilstande (f.eks. hvis du har forhøjet blodtryk, diabetes, forhøjet kolesteroltal eller er ryger) bør du diskutere din behandling med lægen.
English: When concomitant therapy has to be used careful monitoring should be undertaken.
Danish: Når samtidig medicinering er nødvendig, bør nøje overvågning finde sted.
English: - Methotrexate: Increased serum concentration of methotrexate.
Danish: - methotrexat: resulterer i en højere serumkoncentration af methotrexat.
English: 6.1 List of excipients Powder:
Danish: 6.1 Hjælpestoffer Pulver:
English: An initial dose of 16 mg lornoxicam administered i.m., followed by a subsequent dose of 8 mg has shown to be effective and safe in patients with pain after surgery (study CT89).
Danish: En initialdosis på 16 mg im med en efterfølgende dosis på 8 mg vist at være effektiv og sikker ved postoperative smerter (undersøgelse CT89).
English: For all the pharmaceutical forms and strengths of lornoxicam It was agreed that the following contraindications would be included: - The third trimester of pregnancy (see section 4.6)
Danish: For samtlige lægemiddelformer og styrker af lornoxicam gælder følgende: Det blev vedtaget at indsætte følgende kontraindikationer: - Graviditet i tredje trimester (se pkt.
English: Eight patients died after lornoxicam treatment and three patients after treatment with comparators, and no case was reported after parenteral lornoxicam.
Danish: Otte patienter er døde efter behandling med lornoxicam og tre efter behandling med sammenligningspræparaterne.
English: Effects on ability to drive and use machines - Section 4.7
Danish: Virkning på evnen til at føre motorkøretøj eller betjene maskiner - pkt.
English: The overall serious ADR (SADR) incidence for lornoxicam was 0.6%.
Danish: Den totale hyppighed af alvorlige bivirkninger af lornoxicam var 0,6 %.
English: In case of premature termination, data of last observation were chosen.
Danish: For patienter, der udgik af undersøgelsen før tid, anvendtes de senest observerede data.
English: During the first and second trimester of pregnancy, prostaglandin synthesis inhibitors should not be given unless clearly necessary.
Danish: Under første og andet trimester af graviditeten bør prostaglandinsyntese-hæmmere derfor udelukkende gives på tvingende indikation.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS AMPOULE FOR SOLVENT
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ SMÅ INDRE PAKNINGER AMPUL TIL SOLVENS
English: Like all medicines, Xefo Rapid can cause side effects, although not everybody gets them.
Danish: Xefo Rapid kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: Very rare (less than 1 in 10.000 patients treated)
Danish: Ikke almindelige bivirkninger (forekommer hos 1 - 10 ud af 1.000 behandlede):
English: Prostaglandin synthesis inhibitors administered during the third trimester of pregnancy may expose the foetus to cardiopulmonary toxicity (premature closure of the ductus arteriosus and pulmonary hypertension) and renal dysfunction which may lead to renal failure and hence a reduced quantity of amniotic fluid.
Danish: I graviditetens tredje trimester kan prostaglandinsyntesehæmmere udsætte fosteret for kardiopulmonær toksicitet (for tidlig lukning af ductus arteriosus og pulmonær hypertension) og renal dysfunktion, som kan lede til nyresvigt og dermed en reduceret mængde fostervand.
English: There is no significant change in the kinetic profile of lornoxicam in patients with renal or hepatic failure, except for accumulation in patients with chronic liver disease after 7 days of treatment with daily doses of 12 and 16 mg.
Danish: Der ses ingen signifikant ændring i den farmakokinetiske profil for lornoxicam hos patienter med nyre- eller leverinsufficiens, bortset fra akkumulering i patienter med kronisk leversygdom efter behandling i 7 dage med daglige doser på 12 - 16 mg.
English: The usual emergency measures including gastric lavage should be considered.
Danish: De sædvanlige forholdsregler ved forgiftning inklusive maveskylning skal overvejes.
English: The effect on TOTPAR and PPRA with 2 mg and 4 mg in study CT01 was not significantly different from placebo.
Danish: I undersøgelse CT01 var virkningen på TOTPAR og PPRA af 2 mg og 4 mg ikke signifikant forskellig fra placebo.
English: Lornoxicam is absorbed rapidly and almost completely from the gastrointestinal tract.
Danish: Lornoxicam absorberes hurtigt og næsten fuldstændigt fra mave-tarmkanalen.
English: What Xefo looks like and contents of the pack The powder is a yellow, solid substance and the solvent a clear liquid.
Danish: Xefos udseende og pakningstørrelse Pulveret er gult og solvensen er en klar væske.
English: 6 film-coated tablets 10 film-coated tablets 20 film-coated tablets 30 film-coated tablets 50 film-coated tablets 100 film-coated tablets 250 film-coated tablets
Danish: 6 filmovertrukne tabletter 10 filmovertrukne tabletter 20 filmovertrukne tabletter 30 filmovertrukne tabletter 50 filmovertrukne tabletter 100 filmovertrukne tabletter 250 filmovertrukne tabletter
English: TOTPAR in the meta-analysis was significantly different from placebo at 4 mg LNX p.o. and doses >4 mg LNX p.o., however it should be noted that in 2/7 studies (CT01, CT03) the effect of 4 mg LNX on total pain relief was not significantly different from the placebo group.
Danish: I metaanalysen var TOTPAR signifikant forskellig fra placebo ved 4 mg peroralt og >4 mg peroralt, dog bemærkes, at i to af de syv undersøgelser (CT01 og CT03) gav 4 mg ikke signifikant bedre samlet smertelindring end placebo.
English: Powder for injection, 8 mg: Amber glass (class I) vial (4R/8R) with rubber stopper, sealed with aluminium snap-off closure.
Danish: Pulver til injektionsvæske 8 mg: Brunt hætteglas (4R/8R) med gummiprop forseglet med et aluminiumslåg.
English: A plateau of efficacy was obtained with 8mg bid; this dosage regimen is thus considered the maximum dose for lornoxicam in RA.
Danish: Virkningen nåede et plateau ved 8 mg to gange dagligt, som derfor anses for at være den maksimale dosering af lornoxicam ved RA.
English: Meta-analysis 2
Danish: Metaanalyse 2
English: Common: Mild and transient headache, dizziness.
Danish: Almindelig: Mild og forbigående hovedpine, svimmelhed.
English: Lornoxicams mode of action is mainly related to the inhibition of the prostaglandin synthesis (inhibition of the cyclooxygenase enzyme) leading to desensitisation of peripheral nociceptors and consequently inhibition of inflammation.
Danish: Lornoxicams virkningsmekanisme er overvejende relateret til hæmning af prostaglandisyntesen (hæmning af cyclooxygenase-enzymet), som fører til en desensibilisering af de perifere nociceptorer og som konsekvens heraf en hæmning af inflammationen.
English: 6.5 Nature and contents of container Aluminium/Aluminium blister.
Danish: 6.5 Emballagetype og pakningstørrelser Aluminium/Aluminiumblister:
English: - Beta-adrenergic blockers: Decreased antihypertensive efficacy.
Danish: - beta-blokkere: medfører nedsat antihypertensiv virkning.
English: 6.4 Special precautions for storage This medicinal product does not require any special storage conditions
Danish: 6.4 Særlige opbevaringsforhold Dette lægemiddel kræver ingen særlige forholdsregler vedrørende opbevaringen.
English: Immune system disorders Rare: Hypersensitivity.
Danish: Immunsystemet Sjælden: Overfølsomhedsreaktioner.
English: Due to its short half-life, lornoxicam is rapidly excreted.
Danish: På grund af lornoxicams korte halveringstid, udskilles stoffet hurtigt.
English: 6.4 Special precautions for storage Do not store above 30°C.
Danish: 6.4 Særlige opbevaringsforhold Må ikke opbevares over 30° C.
English: - Tacrolimus: Increase the risk of nephrotoxicity owing to reduced synthesis of prostacyclin in the kidney.
Danish: - tacrolimus: medfører øget risiko for nefrotoksitet grundet den reducerede syntese af prostacyclin i nyrerne.
English: The dose-recommendations in the SPC for the 8 mg filmcoated tablets are supported by the presented data.
Danish: Den i produktresuméet anbefalede dosering for 8 mg filmovertrukne tabletter støttes af de forelagte data.
English: Renal impairment For patients with mild to moderate renal impairment dose reduction should be considered (see section
Danish: Nedsat nyrefunktion Til patienter med let til moderat nedsat nyrefunktion bør dosisreduktion overvejes (se pkt.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ BLISTERKORT ELLER BLISTERSTRIPS {blisterfolie}
English: Lornoxicam (Xefo and its associated names) is a non-steroidal anti-inflammatory drug (NSAID) of the oxicam class approved and marketed for treatment of moderate to severe pain.
Danish: Lornoxicam (Xefo og tilknyttede navne) er et non-steroidt antiinflammatorisk lægemiddel (NSAID), der tilhører oxicam-klassen og markedsføres til behandling af moderate til svære smerter.
English: - Heparin: NSAIDs increase the risk of spinal or epidural haematoma when given concomitantly to heparin in the context of spinal or epidural anaesthesia.
Danish: - heparin: NSAID øger risikoen for spinalt eller epiduralt hæmatom, når de gives sammen med heparin i forbindelse med spinal- eller epidural anæstesi (gælder alle NSAID).
English: 10 film-coated tablets 20 film-coated tablets 30 film-coated tablets 50 film-coated tablets 100 film-coated tablets
Danish: 10 filmovertrukne tabletter 20 filmovertrukne tabletter 30 filmovertrukne tabletter 50 filmovertrukne tabletter 100 filmovertrukne tabletter
English: - Short-term relief of acute mild to moderate pain
Danish: - Kortvarig lindring af akutte, milde til moderate smerter
English: Do not use Xefo after the expiry date which is stated on the carton.
Danish: Brug ikke Xefo efter den udløbsdato, der står på pakningen.
English: The use of lornoxicam with concomitant NSAIDs including cyclooxygenase-2 selective inhibitors should be avoided.
Danish: Lornoxicam bør ikke bruges sammen med andre NSAID-præparater inklusive selektive cyclooxygenase-2-hæmmere.
English: Patients with uncontrolled hypertension, congestive heart failure, established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease should only be treated with lornoxicam after careful consideration.
Danish: Patienter med ukontrolleret hypertension, kongestiv hjerteinsufficiens, etableret iskæmisk hjertesygdom, perifer arteriel insufficiens, og/eller cerebrovaskulær sygdom bør kun behandles med lornoxicam efter nøje overvejelse.
English: 4.4 Special warnings and precautions for use For the following disorders, lornoxicam should only be administered after careful risk-benefit assessment: - Renal impairment: Lornoxicam should be administered with precaution in patients with mild (serum creatinine 150-300 µmol/l) to moderate (serum creatinine 300 - 700 µmol/l) renal impairment due to dependency on renal prostaglandins for maintenance of renal blood flow.
Danish: 4.4 Særlige advarsler og forsigtighedsregler vedrørende brugen Ved følgende tilstande bør Lornoxicam kun gives efter en grundig vurdering af fordele og ulemper ved behandlingen: - Nedsat nyrefunktion: Lornoxicam bør administreres med forsigtighed til patienter med let til moderat nedsat nyrefunktion (serumkreatinin 150 - 700 µmol/L).
English: Tablet container:
Danish: Tabletkerne:
English: Lornoxicam is not recommended for use in children and adolescents below age 18 due to a lack of data on safety and efficacy.
Danish: Lornoxicam bør ikke bruges til børn og unge under 18 år på grund af manglende dokumentation for sikkerhed og virkning.
English: PHARMACEUTICAL FORM AND CONTENTS 250 film-coated tablets
Danish: LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE) 250 filmovertrukne tabletter
English: Nephrotoxicity of cyclosporine may be enhanced via renal prostaglandin mediated effects.
Danish: Dette kan betyde, at nefrotoksiciteten af cyclosporin forøges via renale prostaglandin-medierede effekter.
English: Initial recommended dose is 12 mg lornoxicam daily divided into 2 or 3 doses.
Danish: Den initiale, anbefalede dosis er 12 mg lornoxicam daglig fordelt på 2 - 3 doser.
English: After preparation of the solution, change the needle.
Danish: Efter fremstilling af opløsningen udskiftes kanylen.
English: Reconstituted solution: Chemical and physical in-use stability has been demonstrated for 24 hours at 21°C (±2°C).
Danish: Efter opløsning er der vist en kemisk og fysisk stabilitet på 24 timer ved 21º C (+/- 2º C).
English: Gastrointestinal bleeding, ulceration and perforation: GI bleeding, ulceration or perforation, which can be fatal, has been reported with all NSAIDs at anytime during treatment, with or without warning symptoms or a previous history of serious GI events.
Danish: Gastrointestinal blødning, ulceration og perforation: Gastrointestinal blødning, ulceration og perforation, der kan have dødelig udgang, er indberettet for alle NSAID på alle tidspunkter af behandlingen, uanset om der er advarende symptomer eller tidligere alvorlige gastrointestinale hændelser i anamnesen.
English: Do not use Xefo Rapid after the expiry date which is stated on the carton.
Danish: Brug ikke Xefo Rapid efter den udløbsdato, der står på pakningen.
English: Lornoxicam is available as film coated tablets 4 mg and 8 mg, rapid release film-coated tablets 8 mg, and as powder and solvent for solution for injection 4 mg/ml for intramuscular and intravenous injection.
Danish: Lornoxicam leveres som filmovertrukne tabletter, 4 mg og 8 mg, som filmovertrukne tabletter med hurtig udløsning, 8 mg, og som pulver og solvens til injektionsvæske, opløsning, 4 mg/ml, til intramuskulær og intravenøs anvendelse.
English: - Known inducers and inhibitors of CYP2C9 isoenzymes: Lornoxicam (as other NSAIDs depending on the cytochrome P450 2C9 (CYP2C9 isoenzyme)) has interactions with known inducers and inhibitors of CYP2C9 isoenzymes (see section 5.2 Biotransformation).
Danish: - kendte inducere og hæmmere af CYP2C9-isoenzymer: lornoxicam (som andre NSAID, der er afhængige af cytochrome P450 2C9 (CYP2C9) isoenzym) medfører interaktion med CYP2C9isoenzymer (se afsnittet om Metabolisering under pkt.
English: There are no data on the excretion of lornoxicam in human breast milk.
Danish: Der foreligger ingen data om udskillelse af lornoxicam i modermælk.
English: Important information about some of the ingredients of Xefo Xefo 4 mg tablets contain lactose monohydrate.
Danish: Vigtig information om nogle af de øvrige indholdsstoffer i Xefo Xefo 4 mg tabletter indeholder lactose.
English: - Renal functions should be monitored in patients who undergo major surgery, with cardiac failure, receiving treatment with diuretics, receiving concomitant treatment with drugs that are suspected to or known to be able to cause kidney damage.
Danish: - Nyrefunktionen skal monitoreres hos patienter, som får foretaget større operationer, som har hjerteproblemer, som får diuretika, eller som får medicin, kendt eller mistænkt for at kunne skade nyrerne.
English: GROUNDS FOR AMENDMENT OF THE SUMMARIES OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
Danish: BEGRUNDELSE FOR ÆNDRING AF PRODUKTRESUMÉERNE, ETIKETTERING OG INDLÆGSSEDDEL
English: NSAIDs should be given with care to patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease) as their condition may be exacerbated (see section 4.8).
Danish: NSAID bør anvendes med forsigtighed hos patienter med gastrointestinal sygdom i anamnesen (ulcerøs kolitis, Crohns sygdom), da sygdommen kan forværres (se pkt.
English: Xefo is distributed as set containing 1 vial of powder for solution for injection and 1 ampoule of solvent for solution for injection.
Danish: Xefo sælges i sæt indeholdende 1 hætteglas med pulver der opløses til injektionsvæske og 1 ampul med solvens til opløsning til injektionsvæske.
English: Should any such abnormality prove significant or persist the administration of lornoxicam should be stopped and appropriate investigations prescribed.
Danish: Skulle en sådan afvigelse vise sig signifikant eller vedvarende bør behandlingen med lornoxicam stoppes, og passende undersøgelser skal foretages.
English: Overall discussion on OA
Danish: Samlet diskussion vedrørende af OA Vedrørende OA kan følgende sammenfattes:
English: Xefo Rapid should not be used concomitantly with other NSAIDs such as acetylsalicylic acid, ibuprofen and COX-2 inhibitors.
Danish: Xefo Rapid bør ikke bruges sammen med andre NSAID-præparater (f.eks. acetylsalisylsyre, ibuprofen og COX-2 hæmmere).
English: Adults: The recommended dose is 8 mg i.v.
Danish: Voksne: Den anbefalede dosis er 8 mg givet som injektion.
English: Very rare: Oedema and bullous reactions, Stevens-Johnson syndrome, toxic epidermal necrolysis
Danish: Meget sjælden: ødemer and bulløse reaktioner, Stevens-Johnson syndrom, toksisk epidermal nekrolyse.
English: Xefo should not be used concomitantly with other NSAIDs such as acetylsalicylic acid, ibuprofen and COX-2 inhibitors.
Danish: Xefo bør ikke bruges sammen med andre NSAID-præparater (f.eks. acetylsalisylsyre, ibuprofen og COX-2 hæmmere).
English: Patients with uncontrolled hypertension, congestive heart failure, established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease should only be treated with Lornoxicam after careful consideration.
Danish: Hos patienter med ukontrolleret hypertension, kongestiv hjerteinsufficiens, fastslået iskæmisk hjertesygdom, perifer arteriel sygdom og/eller cerebrovaskulær sygdom bør lornoxicam kun anvendes efter nøje overvejelse.
English: Patients with a history of GI toxicity, particularly when elderly, should report any unusual abdominal symptoms (especially GI bleeding) particularly in the initial stages of treatment.
Danish: Patienter, særligt ældre, der tidligere har haft gastrointestinal toksicitet bør rapportere alle usædvanlige abdominale symptomer (særligt gastrointestinal blødning) i særdeleshed i behandlingens startfase.
English: White to yellowish round biconvex film-coated tablet.
Danish: Hvid til gullig, rund, bikonveks, filmovertrukken tablet.
English: For the dose-relationship up to 32 mg only a single study (CT78) included the 16 mg and 32 mg dose, which reduces the relevance of the dose-relationship, i.g.
Danish: Vedrørende dosis-responssammenhængen op til 32 mg blev doser på 16 mg og 32 mg kun anvendt i én undersøgelse (CT78), hvilket nedsætter relevansen af dosisresponssammenhængen; dosisresponssammenhængen for perorale doser over 8 mg bygger således på en enkelt undersøgelse.
English: [To be completed nationally]
Danish: <[Udfyldes nationalt]>
English: Cardiac disorders Uncommon: Palpitations, tachycardia, oedema, cardiac failure.
Danish: Hjerte Ikke almindelig: Palpitationer, takykardi, ødem, hjertesvigt.
English: For all the pharmaceutical forms and strengths of lornoxicam The following wording has been included as agreed by the PhVWP in January 2007: Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4.
Danish: Der er indsat følgende ordlyd, som blev vedtaget af PhVWP i oktober 2005 og januar 2007: Bivirkningerne kan minimeres ved at anvende den laveste effektive dosis i det korteste tidsrum, der behøves til symptomkontrol (se pkt.
English: Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Danish: Fortæl altid lægen eller apoteket, hvis du bruger eller for nylig har brugt anden medicin.
English: Do not store above 25°C.
Danish: Må ikke opbevares over 25° C.
English: Lornoxicam at dosages 4mg tid and 8mg bid is effective in the symptomatic treatment of RA.
Danish: Lornoxicam i en dosering på 4 mg tre gange dagligt og 8 mg to gange dagligt er effektivt til symptomatisk behandling af RA.
English: ANNEX III SUMMARIES OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
Danish: BILAG III PRODUKTRESUME, ETIKETTERING OG INDLÆGSSEDDEL
English: If not used immediately, in-use storage times and conditions prior to use is the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C unless reconstitution/dilution has taken place in controlled and validated aseptic conditions.
Danish: Opbevaringstiden vil normalt ikke være mere end ca. 24 timer ved 2 - 8º C, medmindre opløsningen har fundet sted under kontrollerede og validerede aseptiske forhold.
English: For patients with mild to moderate renal impairment the maximum recommended daily dose is 12 mg divided in 2 or 3 doses (see section 4.4).
Danish: Til patienter med let til moderat nedsat nyrefunktion er den maksimalt anbefalede døgndosis 12 mg fordelt på 2 - 3 doser (se pkt.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
Danish: INDHOLD EFTER VÆGT
English: Important information about some of the ingredients of Xefo Xefo 8 mg tablets contain lactose monohydrate.
Danish: Vigtig information om nogle af de øvrige indholdsstoffer i Xefo Xefo 8 mg tabletter indeholder lactose.
English: Rare: Dyspnoea, cough, bronchospasm.
Danish: Sjælden: Dyspnø, hoste, bronkospasmer.