FrancophonIA/ELRC3.0 huggingface dataset:
English: -AE subgroup (n=423) -AI subgroup (n=313)a a
Danish: -AE-undergruppe (n=423) -AI-undergruppe (n=313)a a
English: e Anaemia includes the following PTs: Anaemia, Haemoglobin decreased, Haematocrit decreased.
Danish: e Anæmi inkluderer de følgende PTs: anæmi, nedsat hæmoglobin, nedsat hæmatokrit.
English: • After injection, immediately apply a single-finger stroke to the activation assisted lever arm to activate the shielding mechanism (see Figure 5).
Danish: assisterede vippearm for at aktivere beskyttelsesmekanismen (se figur 5).
English: Store and transport refrigerated.
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Opbevares i køleskab og transporteres nedkølet.
English: Injection site related events including sciatica, neuralgia, neuropathic pain, and peripheral neuropathy have been reported with fulvestrant injection.
Danish: I forbindelse med administration af fulvestrant er bivirkninger, relateret til injektionsstedet, herunder iskias, neuralgi, neuropatiske smerter og perifer neuropati, observeret og rapporteret.
English: Progression-Free Survival Number of PFS Events (%) PFS Hazard Ratio (95% CI) and pvalue
Danish: Progressionsfri overlevelse Antal PFS-hændelser (%) PFS-hazard ratio (95% CI) og pværdi
English: Store the pre-filled syringe in the original package in order to protect from light.
Danish: Den fyldte injektionssprøjte opbevares i den originale yderpakning for at beskytte mod lys.
English: Progression-free survival (PFS) was the primary endpoint; key secondary efficacy endpoints included objective response rate (ORR), clinical benefit rate (CBR) and overall survival (OS).
Danish: Blandt de vigtigste sekundære effektendepunkter var objektiv responsrate (ORR), klinisk gevinstrate (CBR) og total overlevelse (OS).
English: A safety needle (BD SafetyGlide) for connection to the barrel is also provided.
Danish: Der vedlægges også en beskyttet kanyle (BD SafetyGlideTM) til montering på sprøjten.
English: What Fulvestrant Mylan looks like and contents of the pack Fulvestrant Mylan is a clear, colourless to yellow, viscous solution in a pre-filled syringe fitted with a tamper-evident closure, containing 5 ml solution for injection.
Danish: Fulvestrant Mylan er en klar, farveløs til gul, viskøs væske i en fyldt injektionssprøjte lukket med en sikkerhedsforsegling indeholdende 5 ml injektionsvæske, opløsning.
English: One clear type 1 glass pre-filled syringe with polypropylene plunger rod, fitted with a tamper-evident closure, containing 5 ml Fulvestrant Mylan solution for injection.
Danish: En klar type 1 fyldt glas-injektionssprøjte med et polystyren pumpestempel, der er lukket med sikkerhedsforsegling, indeholdende 5 ml Fulvestrant Mylan injektionsvæske, opløsning.
English: However, since asthenia has been reported very commonly with fulvestrant, caution should be observed by those patients who experience this adverse reaction when driving or operating machinery.
Danish: Derfor skal patienter, som oplever denne bivirkning, være forsigtige, når de fører motorkøretøj eller betjener maskiner.
English: Safety and efficacy have not been evaluated in patients with severe renal impairment (creatinine clearance <30 ml/min), and, therefore, caution is recommended in these patients (see section 4.4).
Danish: (kreatinin-clearance < 30 ml/min), og derfor anbefales forsigtighed ved behandling af disse patienter (se pkt.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Fulvestrant Mylan 250 mg solution for injection in prefilled syringe fulvestrant
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Fulvestrant Mylan 250 mg injektionsvæske, opløsning i fyldt injektionssprøjte fulvestrant i.m.
English: STATEMENT OF ACTIVE SUBSTANCE(S) One pre-filled syringe contains 250 mg fulvestrant in 5 ml solution
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER En fyldt injektionssprøjte indeholder 250 mg fulvestrant i 5 ml opløsning
English: For detailed instructions for administration, see section 6.6.
Danish: For instruktioner om administration af lægemidlet se pkt.
English: Variable Type of estimate
Danish: Type af estimat
English: Do not use Fulvestrant Mylan: - if you are allergic to fulvestrant or to any of the other ingredients of this medicine (listed in section 6) - if you are pregnant or breast-feeding - if you have severe liver problems
Danish: (angivet i afsnit 6) - hvis du er gravid eller ammer - hvis du har alvorlige leverproblemer
English: Castor oil, refined
Danish: Ricinusolie, renset
English: NOTE: Due to the proximity of the underlying sciatic nerve, caution should be taken if administering Fulvestrant Mylan at the dorsogluteal injection site (see section 4.4).
Danish: BEMÆRK: Der bør udvises forsigtighed ved administration af Fulvestrant Mylan i det dorsogluteale injektionsområde på grund af den nært underliggende iskiasnerve (se pkt.
English: Fulvestrant Mylan 250 mg solution for injection in prefilled syringe fulvestrant
Danish: Fulvestrant Mylan 250 mg injektionsvæske, opløsning i fyldt injektionssprøjte fulvestrant
English: Very common Joint and musculoskeletal paind Common
Danish: Meget almindelig Smerter i led, muskler og knoglerd Almindelig
English: All Patients -AE subgroup (n=423) -AI subgroup (n=313) a
Danish: K-M median i måneder; hazard ratio Alle patienter -AE-undergruppe (n=423) -AI-undergruppe (n=313)a
English: Adverse reactions by system organ class and frequency Infections and infestations
Danish: Tabel 1 Bivirkninger rapporteret hos patienter behandlet med fulvestrant monoterapi Bivirkninger efter systemorganklasse og hyppighed Infektioner og parasitære sygdomme
English: - osteoporosis (loss of bone density) - alcoholism
Danish: - previous problems with blood clots - knogleskørhed (nedsat mineralindhold i knoglerne) - alkoholisme
English: Caution should be taken while administering fulvestrant at the dorsogluteal injection site due to the proximity of the underlying sciatic nerve (see sections 4.2 and 4.8).
Danish: Der bør udvises forsigtighed ved administration af fulvestrant i det dorsogluteale injektionsområde på grund af den nært underliggende iskiasnerve (se pkt.
English: Very common Hot flushese Common
Danish: Meget almindelig Hedeturee Almindelig
English: Instructions for administration
Danish: Administrationsinstruktion
English: Injection site haemorrhage f, injection site haematoma f, neuralgiac,f a
Danish: Ikke almindelig Blødning ved injektionsstedetf, hæmatom ved injektionsstedetf, iskias, neuralgic a
English: Combined analysis of both studies showed the hazard ratio of fulvestrant 250 mg to anastrozole for progression-free survival was
Danish: Kombineret analyse for begge studier viste, at hazard ratio for fulvestrant 250 mg i forhold til anastrozol, med henblik på progressionsfri overlevelse var 0,95 (95% konfidensinterval 0,82-1,10).
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Brug af anden medicin sammen med Fulvestrant Mylan Fortæl altid lægen eller apotekspersonalet, hvis du tager anden medicin eller har gjort det for nylig.
English: NAME OF THE MEDICINAL PRODUCT Fulvestrant Mylan 250 mg solution for injection in prefilled syringe
Danish: LÆGEMIDLETS NAVN Fulvestrant Mylan 250 mg injektionsvæske, opløsning i fyldt injektionssprøjte
English: What you need to know before you use Fulvestrant Mylan 3.
Danish: Det skal du vide, før du begynder at bruge Fulvestrant Mylan Sådan skal du bruge Fulvestrant Mylan Bivirkninger
English: When fulvestrant is used in combination with palbociclib, please also refer to the Summary of Product Characteristics of palbociclib.
Danish: Se også produktresuméet for palbociclib, når fulvestrant anvendes i kombination med palbociclib.
English: Vaginal moniliasis f, leukorrhea f
Danish: Vaginal blødninge Ikke almindelig Vaginal candidiasisf, leukoréf
English: Vaginal haemorrhagee
Danish: Mave-tarm-kanalen
English: Very common Rashe
Danish: Meget almindelig Udslæte
English: Reduced platelet counte
Danish: Nedsat antal blodpladere
English: IM use
Danish: ANVENDELSE
English: Table 1 Adverse Drug Reactions reported in patients treated with fulvestrant monotherapy
Danish: Dog er asteni rapporteret som meget almindeligt under behandling med fulvestrant.
English: 2 years
Danish: 6.3 Opbevaringstid 2 år
English: PFS Median [months (95% CI)] Number of OS Events* OS Hazard Ratio (95% CI) and p-value
Danish: Antal OS-hændelser* OS-hazard ratio (95% CI) og pværdi
English: Posology
Danish: Rygsmertera
English: CBR Odds Ratio (95% CI) and p-value
Danish: Klinisk benefit rate Klinisk benefit rate-odds ratio (95% CI) og p-værdi
English: PHARMACEUTICAL FORM Solution for injection.
Danish: Lægemidlet er receptpligtigt.
English: {Invented name}may be taken with or without food.
Danish: {navn} kan tages med eller uden føde.
English: This information will be updated as final data become available.
Danish: Denne information vil blive opdateret, så snart de endelige data foreligger.
English: The increased risk became apparent after approximately 1 year of treatment.
Danish: Den øgede risiko blev synlig efter ca. 1 års behandling.
English: There is a genetic polymorphism of this enzyme.
Danish: Der er en genetisk polymorfisme af dette enzym.
English: 1515 Lefkosia Cyprus
Danish: 1515 Lefkosia Cypern
English: Dosing with food (high fat meal) delays absorption by about 1 hour.
Danish: Indtagelse sammen med føde (fedtrigt måltid) forsinker absorptionen omkring 1 time.
English: There is no clinical experience of overdose.
Danish: Ingen klinisk erfaring med overdosering.
English: LT-01112 Vilnius Lithuania
Danish: LT-01112 Vilnius Litauen
English: Via Robert Koch, 1-2 20152 Milano Italy
Danish: Via Robert Koch, 1-2 20152 Milano Italien
English: Rivium Westlaan 142 2909 LD Capelle a/d IJssel The Netherlands
Danish: Rivium Westlaan 142 2909 LD Capelle a/d IJssel Nederlandene
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES AND NORWAY AND ICELAND
Danish: BILAG 1 LISTE OVER NAVNE, LÆGEMIDDELFORMER OG STYRKER, ADMINISTRATIONSVEJ, OG INDEHAVERE AF MARKEDSFØRINGSTILLADELSE I MEDLEMSSTATERNE, NORGE OG ISLAND
English: 6.3 Shelf-life 3 years.
Danish: 6.3 Opbevaringstid 3 år.
English: The potential for human risk in pregnancy is unknown, but cannot be excluded.
Danish: Den potentielle risiko under graviditet hos mennesker er ikke kendt, men kan ikke udelukkes.
English: Pack of 2, 5, 6, 10, 20, 30, 40, 50, 60, 100, 10x10, 10x30, 10x50, 1x50 unit dose, 1x100 unit dose.
Danish: Fås i pakninger á 2, 5, 6, 10, 20, 30, 40, 50, 60, 100, 10x10, 10x30, 10x50, 1x50 enkeltdosisblister, 1x100 enkeltdosisblister.
English: Avenida de Europa, 20-B Parque Empresarial La Moraleja 28108 Alcobendas, Madrid Spain
Danish: Avenida de Europa, 20-B Parque Empresarial La Moraleja 28108 Alcobendas, Madrid Spanien
English: Less than 1% of the population are poor metabolisers and have an enzyme with decreased activity.
Danish: Mindre end 1% af befolkningen viser dårlig metabolisering og har et enzym med nedsat aktivitet.
English: 1324 Lysaker Norway
Danish: 1324 Lysaker Norge
English: Capsule, hard.
Danish: Hårde kapsler.
English: Two isoforms, COX-1 and COX-2, have been identified.
Danish: Der er identificeret 2 isoformer, COX-1 og COX-2.
English: However, adequate monitoring for methotrexate-related toxicity should be considered when combining these two drugs.
Danish: Alligevel anbefales det at overveje passende monitorering af metotrexatrelateret toksicitet, når disse to lægemidler kombineres.
English: In the absence of an increase in therapeutic benefit after two weeks, other therapeutic options should be considered.
Danish: Hvis der ikke ses en terapeutisk bedring inden for 2 uger, bør andre behandlingsmuligheder overvejes.
English: Known hypersensitivity to sulphonamides.
Danish: Kendt overfølsomhed over for sulfonamider.
English: Patients with estimated creatinine clearance <30 ml/min.
Danish: Patienter med estimeret kreatininclearance < 30 ml/min.
English: The data were inconsistent in comparison with diclofenac (150 mg per day).
Danish: Data var ikke konsekvente i forhold til diclofenac (150 mg daglig).
English: [Very Common (>1/10), Common (³1/100, <1/10) Uncommon (³1/1000, <1/100) Rare (³1/10,000, <1/1000) Very rare (<1/10,000 including isolated cases)]
Danish: Meget almindelig (> 1/10), almindelig (> 1/100 og < 1/10), ikke almindelig (> 1/1000 og 1/100), sjælden (> 1/10.000 og < 1/1000), meget sjælden (< 1/10.000, inklusive enkeltstående rapporter).
English: 6.4 Special precautions for storage Do not store above 30
Danish: 6.4 Særlige opbevaringsforhold Må ikke opbevares over 30°C.
English: Pfizer Europe MA EEIG Ramsgate Road Sandwich
Danish: Pfizer Europe MA EEIG Ramsgate Road
English: Between November 2004 and June 2005, the MAH made oral explanations to the CHMP on cardiovascular and skin safety aspects for celecoxib on 18 January, 15 February, and 25 May 2005.
Danish: Mellem november 2004 og juni 2005 afgav indehaveren af markedsføringstilladelsen mundtlige redegørelser til CHMP vedrørende de kardiovaskulære og hudrelaterede sikkerhedsaspekter for celecoxib den 18. januar, 15. februar og 25. maj 2005.
English: Although it is not a strong inhibitor of this enzyme, a dose reduction may be necessary for individually dose-titrated drugs that are metabolised by CYP2D6 (See 4.5).
Danish: Selv om det ikke er en kraftig hæmmer af dette enzym, kan en dosisnedsættelse blive nødvendig for individuelt dosistitrerede lægemidler, som metaboliseres af CYP2D6 (Se 4.5).
English: - recommended follow up measures to further investigate the safety of celecoxib.
Danish: - anbefaler opfølgningsforanstaltninger til videre undersøgelse af sikkerheden af celecoxib.
English: To continue to make available emerging clinical and epidemiological data through publications and, where possible, in scientific congresses.
Danish: Indehaveren af markedsføringstilladelsen gør fortsat nye kliniske og epidemiologiske data tilgængelige gennem publikationer og, hvor det er muligt, på videnskabelige kongresser.
English: Milton Keynes MK5 8PH United Kingdom
Danish: Milton Keynes MK5 8PH
English: Dialysis is unlikely to be an efficient method of drug removal due to high protein binding.
Danish: Dialyse er sandsynligvis ikke en effektiv måde til at fjerne lægemidlet på grund af høj proteinbinding.
English: Celecoxib is contraindicated in pregnancy and in women who can become pregnant (see 4.3 and 4.4).
Danish: Celecoxib er kontraindiceret under graviditet og til kvinder, som kan blive gravide (se 4.3 og 4.4).
English: Furthermore, the MAH commits to continue dialogue with EMEA/CHMP with regard to study design
Danish: Desuden forpligter indehaveren af markedsføringstilladelsen sig til at fortsætte dialogen med EMEA/CHMP med hensyn til undersøgelsens udformning.
English: Rare: alopecia, photosensitivity
Danish: Sjælden: alopeci, lysfølsomhed
English: Pfizer ApS Lautrupvang 8 2750 Ballerup Denmark
Danish: Pfizer ApS Lautrupvang 8 2750 Ballerup Danmark
English: 6.2 Incompatibilities Not applicable.
Danish: 6.2 Uforligeligheder Ingen.
English: Celecoxib is mainly eliminated by metabolism.
Danish: Celecoxib elimineres hovedsageligt via metabolisme.
English: The dose may, if needed, later be increased to 200 mg twice daily.
Danish: Dosis kan om nødvendigt senere øges til 200 mg 2 gange daglig.
English: Caution is also required in patients taking diuretic treatment or otherwise at risk of hypovolaemia.
Danish: Forsigtighed bør også udvises hos patienter, som er i diuretikabehandling eller som på anden måde har risiko for hypovolæmi.
English: Pfizer Luxembourg SARL, 283, route d'Arlon, L-8011 Strassen, Luksemburg
Danish: Pfizer Luxembourg SARL, 283, route d'Arlon, L-8011 Strassen, Luxembourg
English: The maximum recommended daily dose is 400 mg for both indications.
Danish: Den højest anbefalede daglige dosis er 400 mg for begge indikationer.
English: The CHMP confirmed changes to the Product Information already introduced through a type II variation adopted in May 2005 further to the February USR and requested further changes.
Danish: CHMP bekræftede ændringen af produktinformationen i henhold til den allerede indsendte ansøgning om en type-II-ændring, som blev godkendt i maj 2005 i forlængelse af Urgent Safety Restrictionproceduren vedrørende sikkerheden i februar, og anmodede om yderligere ændringer.
English: The corresponding values in patients with moderate hepatic impairment were 41% and 146% respectively.
Danish: De tilsvarende tal for patienter med moderat nedsat leverfunktion var henholdsvis 41% og 146%.
English: No clinically significant differences were found in PK parameters of celecoxib between elderly African-Americans and Caucasians.
Danish: Der er ikke fundet klinisk signifikante forskelle i celecoxibs PK parametre mellem ældre afroafrikanere og kaukasiere.
English: To provide final study reports for the following long-term trials APC/PreSAP/ADAPT in full, when available.
Danish: Indehaveren af markedsføringstilladelsen fremlægger de endelige undersøgelsesrapporter for følgende langtids-APC/Pre-SAP/ADAPTundersøgelser i deres fulde længde, når de foreligger.
English: Children: Celecoxib is not indicated for use in children.
Danish: Børn: Celecoxib er ikke indiceret til børn.
English: Caution should be exercised when combining celecoxib with warfarin and other oral anticoagulants (See 4.5).
Danish: Forsigtighed bør udvises, når celecoxib kombineres med warfarin og andre antikoagulantia (se 4.5).
English: The main metabolites found in the circulation have no detectable COX-1 or COX-2 activity.
Danish: Hovedmetabolitterne, som findes i cirkulation, har ingen målelig COX-1 eller COX-2 hæmmende aktivitet.
English: NSAIDs may reduce the effect of diuretics and antihypertensive medicinal products.
Danish: NSAID kan nedsætte virkningen af diuretika og antihypertensiva.
English: The significantly lower incidence of this event with celecoxib was maintained with or without acetylsalicylic acid use.
Danish: Den signifikant lavere hyppighed af disse hændelser med celecoxib bevares med eller uden brug af acetylsalicylsyre.
English: 9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION [Item to be completed by the Marketing Authorisation Holder once the Marketing Authorisation has been granted or renewed.]
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE [Punkt udfyldes af indehaver af markedsføringstilladelsen, når markedsføringstilladelsen er blevet udstedt eller fornyet]
English: Severe hepatic dysfunction (serum albumin <25 g/l or Child-Pugh score ³10).
Danish: Svær leverdysfunktion (serumalbumin < 25 g/l eller Child-Pugh score ³ 10).
English: The phase I metabolism is mainly catalysed by CYP2C9.
Danish: Fase I metabolismen katalyseres hovedsageligt af CYP2C9.
English: Davy Avenue Know Hill
Danish: Davy Avenue
English: {Invented Name}100 mg and 200 mg capsules contain lactose (149.7 mg and 49.8 mg, respectively).
Danish: {Navn} 100 mg og 200 mg kapsler indeholder lactose (henholdsvis 149,7 mg og 49,8 mg).
English: Pfizer Hellas A. E. 5, Alketou Street 116 33 Athens Greece
Danish: Pfizer Hellas A. E. 5, Alketou Street 116 33 Athen Grækenland
English: The clinical significance of this in vitro finding is unknown.
Danish: Den kliniske betydning af disse in-vitro fund er ikke kendt.
English: 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 100 mg or 200 mg celecoxib.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING 1 kapsel indeholder 100 mg eller 200 mg celecoxib.
English: Since celecoxib is predominantly metabolised by CYP2C9 it should be used at half the recommended dose in patients receiving fluconazole.
Danish: Da celecoxib overvejende metaboliseres af CYP2C9, bør det bruges i halvdelen af den anbefalede dosis hos patienter, som får fluconazol.
English: Patients should be adequately hydrated and consideration should be given to monitoring of renal function after initiation of concomitant therapy, and periodically thereafter.
Danish: Patienter bør være normalhydrerede, og det bør overvejes at kontrollere nyrefunktionen efter start af kombinationsbehandling, og med jævne mellemrum efterfølgende.
English: Experience in such patients is limited to cirrhotic patients (See 4.3, 4.4 and 5.2).
Danish: Erfaring hos sådanne patienter er begrænset til cirrhotiske patienter (se afsnit 4.3, 4.4 og 5.2).
English: For the primary endpoint complicated ulcers (defined as gastrointestinal bleeding, perforation or obstruction) celecoxib was not significantly different than either ibuprofen or diclofenac individually.
Danish: For det primære endepunkt, komplicerede mavesår (defineret som gastrointestinal blødning, perforation eller obstruktion), var celecoxib ikke signifikant forskellig fra hverken ibuprofen eller diclofenac hver for sig.
English: The CHMP agreed that an Urgent Safety Restriction (USR) on cardiovascular safety was needed to introduce new contraindications and strengthen warnings and information on side effects in the SPC.
Danish: Der var i CHMP enighed om, at det var nødvendigt at iværksætte en Urgent Safety Restriction vedrørende den kardiovaskulære sikkerhed, med indførelse af nye kontraindikationer og skærpede advarsler og oplysninger om bivirkninger i produktresuméet .
English: Kent CT13 9NJ United Kingdom
Danish: Kent CT13 9NJ
English: In April 2005, the FDA (Food and Drug Administration) and the EMEA requested that Pfizer voluntarily withdraw Bextra (valdecoxib) from the market and Pfizer agreed to suspend sale and marketing of Bextra worldwide pending further discussions on the unfavorable risk versus benefit due to data on serious skin reactions.
Danish: Den 7. april 2005 anmodede FDA (Food and Drug Administration) og EMEA Pfizer om frivilligt at trække Bextra (valdecoxib) tilbage fra markedet, og Pfizer indvilligede i at indstille salget og markedsføringen af Bextra på verdensplan, mens man afventede de videre drøftelser af det ugunstige risk/benefit-forhold på grundlag af oplysningerne om alvorlige hudreaktioner.
English: In some patients, with insufficient relief from symptoms, an increased dose of 200 mg twice daily may increase efficacy.
Danish: Hos nogle patienter med utilstrækkelig lindring af symptomer kan en dosisøgning til 200 mg 2 gange daglig øge effekten.
English: Renal function should be monitored when celecoxib and any of these drugs are combined.
Danish: Nyrefunktionen bør derfor monitoreres ved kombination af celecoxib og hvilket som helst af disse stoffer.
English: Plasma concentrations of celecoxib are probably markedly increased in such patients.
Danish: Plasmakoncentrationen af celecoxib er sandsynligvis markant forhøjet hos sådanne patienter.
English: To submit an analysis of spontaneous reports for all serious skin reactions from the analysis of the RegiSCAR database and further discuss results with Rapporteur following submission.
Danish: Indehaveren af markedsføringstilladelsen indsender en analyse af de spontane indberetninger om alle alvorlige hudreaktioner fra analysen af RegiSCARdatabasen og drøfter resultaterne yderligere med Rapporteur efter indsendelsen.
English: Studies in animals (rats and rabbits) have shown reproductive toxicity, including malformations (see 4.3 and 5.3).
Danish: Forsøg med dyr (rotter og kaniner) har vist reproduktionstoksicitet inklusiv misdannelser (se 4.3 og 5.3).
English: As the cardiovascular risks of celecoxib may increase with dose and duration of exposure, the shortest duration possible and the lowest effective daily dose should be used.
Danish: Da den kardiovaskulære risiko ved brug af celecoxib kan øges med dosis og behandlingsvarighed, bør den kortest mulige behandlingstid og den lavest effektive daglige dosis anvendes.
English: Effects of celecoxib on other drugs
Danish: Virkningen af celecoxib på andre lægemidler
English: The dose of individually dose-titrated CYP2D6 substrates may need to be reduced when treatment with celecoxib is initiated or increased if treatment with celecoxib is terminated.
Danish: Doseringen af individuelt dosistitrerede CYP2D6-substrater, bør måske nedsættes, når samtidig behandling med celecoxib initieres, eller øges, hvis behandling med celecoxib afsluttes.