natgillin/translations-raw huggingface dataset:
Den terminale eliminationshalveringstid for idelalisib var 8,2 (interval: 1,9; 37,2) timer, og den tilsyneladende clearance af idelalisib var 14,9 (interval: 5,1; 63,8) l/t efter oral administration af idelalisib 150 mg to gange daglig.
The terminal elimination half-life of idelalisib was 8.2 (range: 1.9; 37.2) hours and the apparent clearance of idelalisib was 14.9 (range: 5.1; 63.8) L/h following idelalisib 150 mg twice daily oral administration.
DOR (måneder) median (95 % CI) PFS (måneder) median (95 % CI) OS (måneder) median (95 % CI)
DOR (months) median (95% CI) PFS (months) median (95% CI) OS (months) median (95% CI)
Dosisjustering er ikke nødvendig når behandlingen med Zydelig påbegyndes for patienter med leteller moderat nedsat leverfunktion, men det anbefales at intensivere overvågning for bivirkninger (se pkt.
No dose adjustment is required when initiating treatment with Zydelig in patients with mild or moderate hepatic impairment, but an intensified monitoring of adverse reactions is recommended (see sections 4.4 and 5.2).
Microkrystallinsk cellulose, hydroxypropylcellulose (E463), croscarmellosenatrium, carboxymethylstivelsesnatrium, magnesiumstearat.
Microcrystalline cellulose, hydroxypropyl cellulose (E463), croscarmellose sodium, sodium starch glycolate, magnesium stearate.
Hos rotter har idelalisib potentialet for at hæmme T-afhængigt antistofrespons.
In rats, idelalisib has the potential to inhibit T-dependent antibody responses.
CI: konfidensinterval; O: ofatumumab; N: antal patienter pr. gruppe
CI: confidence interval; O: ofatumumab; N: number of subjects per group
Studie 312-0119 var et randomiseret, kontrolleret, åbent studie, hvor 173 patienter med tidligere behandlet CLL fik idelalisib + ofatumumab.
Study 312-0119 was a randomised, controlled, open-label study in which 173 subjects with previously treated CLL received idelalisib + ofatumumab.
Behandlingen med Zydelig skal pauseres i tilfælde af grad 3 eller 4 udslæt.
Treatment with Zydelig must be withheld in the event of Grade 3 or 4 rash.
Fortsæt Zydelig-dosering.
Maintain Zydelig dosing.
• alfentanil, fentanyl, metadon, buprenorfin/naloxon, lægemidler, der anvendes til smertelindring
• alfentanil, fentanyl, methadone, buprenorphine/naloxone, medicines used for pain relief
Studie 312-0116 var et randomiseret, dobbeltblindt, placebokontrolleret studie, hvor 110 patienter med tidligere behandlet CLL fik idelalisib + rituximab.
Study 312-0116 was a randomised, double-blind, placebo-controlled study in which 110 subjects with previously treated CLL received idelalisib + rituximab.
Hvis hændelsen vender tilbage, pauseres behandlingen med Zydelig indtil værdierne er vendt tilbage til grad 1 eller derunder, hvorefter en genstart med 100 mg to gange dagligt kan overvejes efter lægens skøn (se pkt.
If the event recurs, treatment with Zydelig must be withheld until the values return to Grade 1 or less, after which re-initiation at 100 mg twice daily may be considered at the discretion of the physician (see sections 4.4 and 4.8).
ORR var 96,9 %, med 12 CR'er (18,8 %) og 50 PR'er (78,1 %), herunder 3 CR'er og 6 PR'er hos patienter med en 17p-deletion og/eller TP53-mutation, og 2 CR'er og 34 PR'er hos patienter med ikke muteret IGHV.
The ORR was 96.9%, with 12 CRs (18.8%) and 50 PRs (78.1%), including 3 CRs and 6 PRs in subjects with a 17p deletion and/or TP53 mutation and 2 CRs and 34 PRs in subjects with unmutated IGHV.
Lægemiddel
Medicinal product
Orange, oval, filmovertrukken tablet med dimensionerne 9,7 mm x 6,0 mm, påtrykt ”GSI” på den ene side og ”100” på den anden side.
Orange, oval-shaped, film-coated tablet of dimensions 9.7 mm by 6.0 mm, debossed on one side with “GSI” and “100” on the other side.
Den første infusion af ofatumumab blev administreret med en dosis på 300 mg og efterfølgende infusioner med en dosis på enten 1.000 mg i gruppen med idelalisib + ofatumumab eller en dosis på 2.000 mg i gruppen kun med ofatumumab.
The first infusion of ofatumumab was administered at a dose of 300 mg and was continued at a dose of either 1,000 mg in the idelalisib + ofatumumab group or a dose of 2,000 mg in the ofatumumab only group, weekly for 7 doses, and then every 4 weeks for 4 doses.
Hepatocellulær leverskade
Hepatocellular injury
Hver filmovertrukken tablet indeholder 100 mg idelalisib.
Each film-coated tablet contains 100 mg of idelalisib.
• buspiron, clorazepat, diazepam, estazolam, flurazepam, zolpidem, lægemidler, der anvendes til at behandle lidelser i nervesystemet
• buspirone, clorazepate, diazepam, estazolam, flurazepam, zolpidem, medicines used to treat nervous system disorders
Idelalisib bør ikke administreres sammen med amiodaron eller kinidin.
Idelalisib should not be co-administered with amiodarone or quinidine.
Hvis hændelsen ikke vender tilbage, kan dosis igen øges til 150 mg to gange dagligt efter den behandlende læges skøn.
If the event does not recur, the dose can be re-escalated to 150 mg twice daily at the discretion of the treating physician.
Mave-tarm-kanalen Diarré/colitis
Gastrointestinal disorders Diarrhoea/colitis
Lyserød, oval, filmovertrukken tablet med dimensionerne 10,0 mm x 6,8 mm, påtrykt ”GSI” på den ene side og ”150” på den anden side.
Pink, oval-shaped, film-coated tablet of dimensions 10.0 mm by 6.8 mm, debossed on one side with “GSI” and “150” on the other side.
Idelalisib bør ikke administreres sammen med sildenafil.
Idelalisib should not be co-administered with sildenafil.
• colchicin, et lægemiddel, der anvendes til at behandle podagra
• colchicine, a medicine used to treat gout
↑ serumkoncentrationer Klinisk overvågning af terapeutisk virkning og bivirkninger anbefales.
↑ serum concentrations Clinical monitoring of therapeutic effect and adverse reactions is recommended.
Dosismodifikation
Dose modification
Hvis du har sprunget en dosis over, og det er mindre end 6 timer siden, du skulle have taget dosen, skal du straks tage den glemte dosis.
If you miss a dose by less than 6 hours, take the missed dose right away.
↑ serumkoncentrationer Terapeutisk overvågning anbefales.
↑ serum concentrations Therapeutic monitoring is recommended.
Hver filmovertrukken tablet indeholder 150 mg idelalisib.
Each film-coated tablet contains 150 mg of idelalisib.
Behandlingen med Zydelig skal pauseres i tilfælde af grad 3 eller 4 forhøjelser i ALAT/ASAT, og leverfunktionen skal overvåges.
Treatment with Zydelig must be withheld in the event of Grade 3 or 4 ALT/AST elevation and liver function monitored.
Idelalisib er en selektiv hæmmer af bindingen af adenosin-5'-triphosphat (ATP) til det katalytiske domæne af PI3Kδ, hvilket fører til en hæmning af fosforyleringen af phosphatidylinositol,
Idelalisib is a selective inhibitor of adenosine-5'-triphosphate (ATP) binding to the catalytic domain of PI3Kδ, resulting in inhibition of the phosphorylation of the key lipid second messenger phosphatidylinositol and prevention of Akt (protein kinase B) phosphorylation.
Idelalisib bør ikke administreres sammen med colchicin til patienter med nedsat nyre- eller leverfunktion.
Idelalisib should not be co-administered with colchicine to patients with renal or hepatic impairment.
Medianalderen var 71 år (interval: 47 til 92), hvor 78,2 % af patienterne var over 65 år; 65,5 % var mænd og 90,0 % var hvide, 64,1 % have et Rai-stadie på III eller IV, og 55,9 % havde et Binet-stadie på C. De fleste patienter havde dårlige cytogenetiske prognostiske faktorer: 43,2 % havde en 17p kromosomdeletion og/eller tumorprotein 53 (TP53) mutation, og 83,6 % havde ikke muterede gener i den variable region af den tunge kæde af immunglobulinet (IGHV).
The median age was 71 years (range: 47 to 92) with 78.2% of subjects over 65 years; 65.5% were male, and 90.0% were white; 64.1% had a Rai stage of III or IV, and 55.9% had Binet Stage C. Most subjects had adverse cytogenetic prognostic factors: 43.2% had a 17p chromosomal deletion and/or tumour protein 53 (TP53) mutation, and 83.6% had unmutated genes for the immunoglobulin heavy chain variable region (IGHV).
• itraconazol, ketoconazol, posaconazol, voriconazol, lægemidler, der anvendes til at behandle svampeinfektioner
• itraconazole, ketoconazole, posaconazole, voriconazole, medicines used to treat fungal infections • boceprevir, telaprevir, medicines used to treat hepatitis C
Hazard ratio (95 % CI) P-værdi ORR* n (%) (95 % CI) Odds ratio (95 % CI) P-værdi LNR** n/N (%) (95 % CI) Odds ratio (95 % CI) P-værdi OS^ Median (måneder) (95 % CI)
Hazard ratio (95% CI) P-value ORR* n (%) (95% CI) Odds ratio (95% CI) P-value LNR** n/N (%) (95% CI) Odds ratio (95% CI) P-value OS^ Median (months) (95% CI)
Klinisk virkning ved kronisk lymfatisk leukæmi
Clinical efficacy in chronic lymphocytic leukaemia
↑ serumkoncentrationer Idelalisib bør ikke administreres sammen med quetiapin eller pimozid.
↑ serum concentrations Idelalisib should not be co-administered with quetiapine or pimozide.
De filmovertrukne tabletter er orange, ovale tabletter, påtrykt ”GSI” på den ene side og ”100” på den anden side.
The film-coated tablets are orange, oval-shaped tablets, debossed on one side with “GSI” and “100” on the other side.
Zydelig (100 mg filmovertrukne tabletter) indeholder sunset yellow FCF, hvilket kan medføre allergiske reaktioner.
Zydelig contains sunset yellow FCF which may cause allergic reactions.
Hjælpestoffer Zydelig indeholder azo-farvestoffet sunset yellow FCF (E110), som kan medføre allergiske reaktioner.
Zydelig contains the azo colouring agent sunset yellow FCF (E110), which may cause allergic reactions.
Idelalisibs primære metabolit, GS-563117, er en kraftig CYP3A4-hæmmer.
The primary metabolite of idelalisib, GS-563117, is a strong CYP3A4 inhibitor.
4.4) Sjældne tilfælde af SJS og TEN er forekommet, når idelalisib blev administreret samtidigt med andre lægemidler forbundet med disse syndromer (bendamustin, rituximab, allopurinol og amoxicillin).
Stevens-Johnson syndrome and toxic epidermal necrolysis (see section 4.4) Rarely, cases of SJS and TEN have occurred when idelalisib was administered concomitantly with other medicinal products associated with these syndromes (bendamustine, rituximab, allopurinol, and amoxicillin).
Når diarréen/colitisen er vendt tilbage til grad 1 eller derunder, kan behandlingen genoptages med 100 mg to gange dagligt.
Once diarrhoea/colitis has returned to Grade 1 or below, treatment can be resumed at 100 mg twice daily.
Lever og galdeveje Forhøjet transaminase
Elevated liver transaminases
Medianalderen var 68 år (interval 61-74), hvor 64,0 % af patienterne var over 65 år, 71,3 % var mænd, og 84,3 % var hvide, 63,6 % have Rai-stadie III eller IV, og 58,2 % havde Binet-stadie C. De fleste patienter havde prognostisk dårlige cytogenetiske faktorer: 39,5 % havde 17p-kromosomdeletion og/eller TP53-mutation, og 78,5 % havde ikke-muterede gener for IGHV.
The median age was 68 years (range: 61 to 74) with 64.0% of subjects over 65 years; 71.3% were male, and 84.3% were white; 63.6% had a Rai stage of III or IV, and 58.2% had Binet Stage C. Most subjects had adverse cytogenetic prognostic factors: 39.5% had a 17p chromosomal deletion and/or TP53 mutation, and 78.5% had unmutated genes for IGHV.
Tabel 4: Oversigt over PFS og responsrater i præspecificerede undergrupper fra studie Idelalisib + R
Table 4: Summary of PFS and response rates in pre-specified subgroups from study 312-0116 Idelalisib + R
De filmovertrukne tabletter er lyserøde, ovale tabletter, påtrykt ”GSI” på den ene side og ”150” på den anden side.
The film-coated tablets are pink, oval-shaped tablets, debossed on one side with “GSI” and “150” on the other side.
Idelalisib i kombination med ofatumumab
Idelalisib in combination with ofatumumab
Hvis diarréen/colitisen ikke vender tilbage, kan dosis igen øges til 150 mg to gange dagligt efter den behandlende læges skøn (se pkt.
If diarrhoea/colitis does not recur, the dose can be re-escalated to 150 mg twice daily at the discretion of the treating physician (see section 4.8).
CI: konfidensinterval; R: rituximab; N: antal patienter pr. gruppe; NR: ikke nået (not reached)
CI: confidence interval; R: rituximab; N: number of subjects per group; NR: not reached
Sådan skal du tage Zydelig
How to take Zydelig
Idelalisibs primære metabolit, GS-563117, er en kraftig CYP3A-hæmmer.
The primary metabolite of idelalisib, GS-563117, is a strong CYP3A inhibitor.
Median PFS (måneder) (95 % CI) Hazard ratio (95 % CI) ORR (95 % CI)
PFS median (months) (95% CI) Hazard ratio (95% CI) ORR (95% CI)
Hjælpestof, som behandleren skal være opmærksom på Hver tablet indeholder 0,1 mg sunset yellow FCF (E110) (se pkt.
Each tablet contains 0.1 mg sunset yellow FCF (E110) (see section 4.4).
PFS median (måneder) (95 % CI)
PFS median (months) (95% CI)
Klinisk virkning ved follikulært lymfom
Clinical efficacy in follicular lymphoma
Polyvinylalkohol (E1203), macrogol 3350 (E1521), titandioxid (E171), talcum (E553B), sunset yellow FCF (E110) (se afsnit 2, Det skal du vide, før du begynder at tage Zydelig).
Polyvinyl alcohol (E1203), macrogol 3350 (E1521), titanium dioxide (E171), talc (E553B), sunset yellow FCF (E110) (see Section 2, What you need to know before you take Zydelig).
↑ serumkoncentrationer Klinisk overvågning anbefales.
↑ serum concentrations Clinical monitoring is recommended.
↑ serumkoncentrationer Idelalisib bør ikke administreres sammen med cisaprid.
↑ serum concentrations Idelalisib should not be co-administered with cisapride.
Median PFS (måneder) (95 % CI) Hazard ratio (95 % CI) P-værdi ORR* n (%) (95 % CI) Oddsratio (95 % CI) P-værdi LNR** n/N (%) (95 % CI) Oddsratio (95 % CI) P-værdi Median OS (måneder) (95 % CI)
PFS Median (months) (95% CI) Hazard ratio (95% CI) P-value ORR* n (%) (95% CI) Odds ratio (95% CI) P-value LNR** n/N (%) (95% CI) Odds ratio (95% CI) P-value OS Median (months) (95% CI)
Zydelig 150 mg filmovertrukne tabletter
Zydelig 150 mg film-coated tablets
↑ serumkoncentrationer Idelalisib bør ikke administreres sammen med alfuzosin.
↑ serum concentrations Idelalisib should not be co-administered with alfuzosin.
• dasatinib, nilotinib, paclitaxel, vinblastin, vincristin, lægemidler, der anvendes til at behandle kræft
• dasatinib, nilotinib, paclitaxel, vinblastine, vincristine, medicines used to treat cancer • oral or implanted hormonal contraceptives, used to prevent pregnancy
Indlægsseddel: Information til patienten Zydelig 150 mg filmovertrukne tabletter idelalisib
Package leaflet: Information for the patient Zydelig 150 mg film-coated tablets idelalisib
Zydelig 100 mg filmovertrukne tabletter
Zydelig 100 mg film-coated tablets
Hvis du har taget for meget Zydelig
If you take more Zydelig than you should
FOSFODIESTERASEHÆMMERE
PHOSPHODIESTERASE INHIBITORS
Indlægsseddel: Information til patienten Zydelig 100 mg filmovertrukne tabletter idelalisib
Package leaflet: Information for the patient Zydelig 100 mg film-coated tablets idelalisib
Zydelig 100 mg filmovertrukne tabletter idelalisib
Zydelig 100 mg film-coated tablets idelalisib
Inhalerede/nasale kortikosteroider:
Inhaled/nasal corticosteroids: Budesonide, fluticasone
• lungebetændelse
• inflammation of the lungs
CI: konfidensinterval; R: rituximab; n: antal patienter, der responderer; N: antal patienter i gruppen; NR: ikke nået (not reached).
CI: confidence interval; R: rituximab; n: number of responding subjects; N: number of subjects per group; NR: not reached.
Zydelig 150 mg filmovertrukne tabletter idelalisib
Zydelig 150 mg film-coated tablets idelalisib
ANTIKOAGULANTIA
ANTICOAGULANTS
CI: konfidensinterval; O: ofatumumab; n: antal patienter, der responderer; N: antal patienter i gruppen; NR: ikke nået (not reached).
CI: confidence interval; O: ofatumumab; n: number of responding subjects; N: number of subjects per group; NR: not reached.
• leverbeskadigelse
• liver damage
Når udslættet er vendt tilbage til grad 1 eller derunder, kan behandlingen genoptages med 100 mg to gange dagligt.
Once rash has returned to Grade 1 or below, treatment can be resumed at 100 mg twice daily.
MÆRKNING, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE ETIKETTERING PÅ TABLETBEHOLDER
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE LABEL
Hvis udslættet ikke vender tilbage, kan dosis igen øges til 150 mg to gange dagligt efter den behandlende læges skøn (se pkt.
If rash does not recur, the dose can be re-escalated to 150 mg twice daily at the discretion of the treating physician (see section 4.8).
ANTIKONVULSIVA
ANTICONVULSANTS
• atorvastatin, lovastatin, simvastatin, lægemidler, der anvendes til at sænke kolesterolniveauet Zydelig kan ordineres i kombination med andre lægemidler til behandling af CLL.
• atorvastatin, lovastatin, simvastatin, medicines used to lower cholesterol
Polyvinylalkohol (E1203) Macrogol 3350 (E1521) Titandioxid (E171) Talcum (E553B) Sunset yellow FCF (E110).
Polyvinyl alcohol (E1203) Macrogol 3350 (E1521) Titanium dioxide (E171) Talc (E553B) Sunset yellow FCF (E110)
Filmovertræk Polyvinylalkohol (E1203) Macrogol 3350 (E1521) Titandioxid (E171) Talcum (E553B) Rød jernoxid (E172)
Polyvinyl alcohol (E1203) Macrogol 3350 (E1521) Titanium dioxide (E171) Talc (E553B) Iron oxide red (E172)
Polyvinylalkohol (E1203), macrogol 3350 (E1521), titandioxid (E171), talcum (E553B), rød jernoxid (E172).
Polyvinyl alcohol (E1203), macrogol 3350 (E1521), titanium dioxide (E171), talc (E553B), iron oxide red (E172).
• dabigatran, warfarin, lægemidler, der anvendes til at fortynde blodet
• alfuzosin, a medicine used to treat an enlarged prostate • dabigatran, warfarin, medicines used to thin the blood
Det skal du vide, før du begynder at tage Zydelig Sådan skal du tage Zydelig Bivirkninger
What Zydelig is and what it is used for What you need to know before you take Zydelig How to take Zydelig
↑ serumkoncentrationer Salmeterol bør ikke administreres sammen med idelalisib.
↑ serum concentrations Concurrent administration of salmeterol and idelalisib is not recommended.
SEKALEALKALOIDER
ERGOT ALKALOIDS
• Prikbladet perikon (Hypericum perforatum), et naturlægemiddel mod depression og angst
• rifampicin, a medicine used to prevent and treat tuberculosis and other infections • St. John's wort (Hypericum perforatum), a herbal remedy used for depression and anxiety
Udseende og pakningsstørrelser
What Zydelig looks like and contents of the pack
7 x 15 mg + 7 x
28 tablets (7 x 5 mg + 7 x 10 mg + 7 x 15 mg + 7 x 20 mg)
- Eimeria acervulina, stamme 003 - 332 - 450 sporulerede oocyster - Eimeria brunetti, stamme 034 - 213 - 288 sporulerede oocyster - Eimeria maxima, stamme 013 - 196 - 265 sporulerede oocyster - Eimeria necatrix, stamme 033 - 340 - 460 sporulerede oocyster - Eimeria tenella, stamme 004 - 276 - 374 sporulerede oocyster
--1 - Eimeria acervulina, strain 003 - 332-450 sporulated oocysts - Eimeria brunetti, strain 034 - 213-288 sporulated oocysts - Eimeria maxima, strain 013 - 196-265 sporulated oocysts - Eimeria necatrix, strain 033 - 340-460 sporulated oocysts - Eimeria tenella, strain 004 - 276-374 sporulated oocysts
Data fra tabel 2.13 i Klinisk sikkerhedsrapport dateret den 21. december 2001
Data from table 2.13 in Clinical Safety Report, dated 21 December 2001
Det kan være skadeligt for dem, selvom de har de samme symptomer, som du har.
It may harm them, even if their symptoms are the same as yours.
Alvorlige bivirkninger/dødsfald/andre betydningsfulde hændelser
Serious adverse event/deaths/other significant events
Det blev vedtaget indsætte følgende erklæring:
It was agreed that the following statement would be included:
Meget almindelig (≥1/10); Almindelig (≥1/100, <1/10); Ikke almindelig (≥1/1000, <1/100); Sjælden (≥1/10.000, <1/1.000); Meget sjælden (<1/10.000).
Very common (≥1/10); Common (≥1/100, <1/10); Uncommon (≥1/1000, <1/100); rare (≥1/10.000, <1/1.000); Very rare (<1/10.000).
Samlet diskussion vedrørende af RA Vedrørende RA kan følgende sammenfattes:
Overall discussion on RA With respect to RA, the following can be summarised:
Indgår i analyse
Included in analysis
Der blev ikke iagttaget forskelle i parameteren SPID.
No differences were observed regarding the SPID parameter.
• Konklusioner
• Conclusions
Tabletterne bør tages før et måltid.
The tablets should be taken before meals.
Der indgik over 12 000 patienter i de 103 undersøgelser, af hvilke 43 var klassificeret som fase I og omfattede 810 patienter.
More than 12,000 patients were included in the 103 studies of which 43 were classified as phase I with 810 patients.
Alt i alt har ansøgeren besvaret de under proceduren rejste spørgsmål tilfredsstillende, dog er der mindre mangler i ansøgerens database vedrørende virkning og sikkerhed, hovedsagelig i forbindelse med små, kortvarige kliniske undersøgelser, der er udført for 15-20 år siden.
Overall the Applicant has responded to the questions raised during the procedure in a satisfactory way, although minor deficits exist in the MAH's efficacy and safety database mainly related to small shortterm clinical studies conducted 15-20 years ago.
Disse patienter bør indlede behandlingen med den lavest mulige dosis.
These patients should commence treatment on the lowest dose available.
Den statistiske analyse blev derfor begrænset til en fire ugers behandlingsfase, der i henhold til internationale retningslinjer er passende til vurdering af den terapeutiske virkning af NSAID ved OA.
Statistical analysis was therefore limited to a 4 week treatment phase which, based on international guidelines, is appropriate to assess therapeutic efficacy of NSAIDs in OA.
Gastritis ses mindre hyppigt.
Less frequently, gastritis has been observed.
En central effekt af nociception, som er uafhængig af de anti-inflammatoriske effekter, har også været foreslået.
A central effect on nociception which seems to be independent of anti-inflammatory effects has also been suggested.
For yderligere instruktion omkring håndtering af produktet inden administration, se pkt.
For further instructions on handling of the product before administration, see section 6.1.
Lornoxicam blev testet i 34 smerteundersøgelser med 7 761 patienter.
Lornoxicam was tested in 34 pain studies with 7,761 patients.
Solvens: klar opløsning
Solvent: Clear solution
Den tredje patient døde af myokardieinfarkt.
The third died from myocardial infarction.
Behandling af osteoartritis er ikke godkendt i 2 af 16 medlemsstater (EE, IT).
Treatment of osteoarthritis has not been approved by 2/16 Member States (EE, IT).
1 sæt indeholder:
1 set contains:
Klinisk overvågning med regelmæssige intervaller anbefales.
Clinical monitoring at regular intervals is recommended.
De bivirkninger, der anføres nedenfor, forekom generelt hos mere end 0,05% af de 6.417 patienter, der blev behandlet i de kliniske fase II-, III- og IV-forsøg.
Listed below are undesirable effects which generally occurred in more than 0.05% of the 6.417 patients treated in clinical phase II, III and IV trials.
Der er ingen kendt specifik antidot.
No specific antidote is known to date.
Yderligere information om bestemte befolkningsgrupper
Additional information on special populations
Læs denne indlægsseddel grundigt, inden du begynder at bruge medicinen.
Read all of this leaflet carefully before you start taking this medicine.
(Der er ikke påvist interaktion mellem lornoxicam og ranitidin, eller mellem lornoxicam og antacida).
(No interaction between lornoxicam and ranitidine, or lornoxicam and antacids has been demonstrated).
Af det totale antal patienter fik 57,8 % (7 046/12 192) lornoxicam (se nedenstående tabel).
Of the total number of patients 57.8% (7,046/12,192) received lornoxicam (see Table below).
De nye kerneoplysninger fra PhVWP vedrørende den kardiovaskulære sikkerhed af NSAID (januar 2007) er ligeledes taget i betragtning.
The recent PhVWP core information regarding cardiovascular safety of NSAIDs (January 2007) has also been taken into account.
Hvis der er synlige tegn på nedbrydning af lægemidlet, skal produktet kasseres i henhold til lokale retningslinier.
If visible signs of deterioration are seen in the medicinal product, the product must be disposed of in accordance with local requirements
SAMLET RESUMÉ AF DEN FAGLIGE VURDERING AF XEFO OG TILKNYTTEDE NAVNE (se bilag I)
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF XEFO AND ASSOCIATED NAMES (see Annex I)
Absorptionen af lornoxicam (beregnet på AUC) kan blive reduceret med op til 20 %.
The absorption of lornoxicam (calculated on AUC) can be reduced up to 20 %.