FrancophonIA/ELRC3.0 huggingface dataset:
English: • Allergic skin rash frequently associated with pruritus
Danish: Allergisk hududslæt ofte forbundet med kløe, alopeci
English: Gemcitabine is indicated for the treatment of locally advanced or metastatic bladder cancer in combination with cisplatin.
Danish: Gemcitabin er indiceret til behandling af lokalt fremskreden eller metastatisk blærecancer i kombination med cisplatin.
English: In patients with impaired bone marrow function, the treatment should be started with caution.
Danish: Behandlingen skal startes med forsigtighed hos patienter med nedsat knoglemarvsfunktion.
English: • Platelets < 25,000 x 106/l
Danish: • Febril neutropeni • Blodplader < 25.000 x 10
English: Pulmonary
Danish: Pulmonært
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains gemcitabine hydrochloride equivalent to 200 mg gemcitabine.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hvert hætteglas indeholder gemcitabinhydrochlorid svarende til 200 mg gemcitabin.
English: • Sweating
Danish: Sveder mere
English: Gemcitabine in combination with carboplatin is recommended using gemcitabine 1000 mg/m2 administered on Days 1 and 8 of each 21-day cycle as a 30-minute intravenous infusion.
Danish: Ovariecancer Kombinationsbehandling Gemcitabin i kombination med carboplatin anbefales administreret på følgende måde: På dag 1 og 8 af hver 21 dages cyklus indgives 1000 mg/m2 gemcitabin, som en 30-minutters intravenøs infusion.
English: • Mild proteinuria
Danish: Hæmaturi og mild proteinuri
English: Recommended posology
Danish: Anbefalet dosering
English: Grade 3 and 4 Adverse Events Paclitaxel versus gemcitabine plus paclitaxel Number (%) of Patients Paclitaxel arm (N=259)
Danish: Grad 3 og 4 bivirkninger Paclitaxel versus gemcitabin plus paclitaxel Antal (%) patienter
English: Each 200 mg vial contains 3.5 mg (<1 mmol) sodium.
Danish: Hvert 200 mg hætteglas indeholder 3,5 mg (<1 mmol) natrium.
English: - This medicine has been prescribed for you.
Danish: - Lægen har ordineret Gemzar til dig personligt.
English: One vial contains gemcitabine hydrochloride equivalent to 1000 mg gemcitabine.
Danish: Et hætteglas indeholder gemcitabinhydrochlorid, svarende til 1000 mg gemcitabin.
English: When prepared as directed, chemical and physical in-use stability of reconstituted solutions of gemcitabine were demonstrated for 24 hours at 30°C.
Danish: Når opblandingen er udført som foreskrevet, er det vist at blandingsopløsningen er fysisk og kemisk stabil ved brug i 24 timer ved 30°C.
English: “Gemcitabine is indicated in the treatment of locally advance or metastatic bladder cancer in combination with cisplatin.”.
Danish: “Gemcitabin er indikeret til behandling af lokalt fremskreden eller metastaserende blærecancer i kombination med cisplatin”.
English: CLASSIFICATION FOR SUPPLY [To be completed nationally]
Danish: GENEREL KLASSIFIKATION FOR UDLEVERING [Udfyldes nationalt]
English: Lilly France S.A.S., rue du Colonel Lilly, F-67640, Fegersheim, France This leaflet was last approved in
Danish: Lilly France S.A.S., rue du Colonel Lilly, F-67640, Fegersheim, France
English: Mean volume of distribution of central compartment: 18 l/m2 (range 11-22 l/m2).
Danish: Gennemsnitligt fordelingsvolumen i det centrale fordelingsrum: 18 l/m
English: Sleepiness
Danish: Søvnighed
English: • common: affects 1 to 10 users in 100
Danish: • Almindelige bivirkninger: Forekommer hos mellem 1 og 10 ud af 100 patienter.
English: “Gemcitabine is indicated for the treatment of patients with locally advanced or metastatic adenocarcinoma of the pancreas”.
Danish: “Gemcitabin er indikeret til behandling af patienter med lokalt fremskreden eller metastaserende adenokarcinom i pancreas”.
English: Combination use in bladder cancer
Danish: Kombinationsbehandling ved blærecancer
English: The CHMP agreed that gemcitabine used as single agent has shown activity against NSCLC but considered that the combination treatment with gemcitabine + cisplatin is the first line of treatment in patients with advanced/metastatic NSCLC and therefore asked the MAH to further justify the indication of Gemzar as combination treatment and as single agent in NSCLC, bearing in mind that single-agent therapy will usually be restricted to patients with a borderline performance status, elderly patients or pretreated patients.
Danish: CHMP bad derfor indehaveren af markedsføringstilladelsen om yderligere at begrunde indikationen for Gemzar til kombinationsbehandling og som enkeltstof i forbindelse med NSCLC, idet det skal erindres, at enkeltstofbehandling sædvanligvis begrænses til patienter, hvis performance status er et grænsetilfælde, ældre patienter eller forbehandlede patienter.
English: Laboratory Anaemia Thrombocytopaenia Neutropaenia Non-laboratory Febrile neutropaenia Fatigue Diarrhoea Motor neuropathy Sensory neuropathy *Grade 4 neutropaenia lasting for more than 7 days occurred in 12.6% of patients in the combination arm and 5.0% of patients in the paclitaxel arm.
Danish: Grad 4 neutropeni, som varer mere end 7 dage, forekom hos 12,6% af patienterne i kombinationsarmen og hos 5,0% af patienterne i paclitaxelarmen.
English: Each vial contains gemcitabine hydrochloride equivalent to 1000 mg gemcitabine
Danish: Hvert hætteglas indeholder gemcitabinhydrochlorid svarende til 1000 mg gemcitabin.
English: OTHER SPECIAL WARNING(S), IF NECESSARY Do not refrigerate the reconstituted solution
Danish: EVENTUELLE ANDRE SÆRLIGE ADVARSLER Den fortyndede opløsning må ikke opbevares i køleskab.
English: Grade 3 and 4 Adverse Events Carboplatin versus Gemcitabine plus carboplatin Number (%) of Patients Carboplatin arm (N=174)
Danish: Grad 3 og 4 bivirkninger Carboplatin versus gemcitabin plus carboplatin Antal (%) patienter
English: Gemcitabine is mutagenic in an in vitro mutation test and an in vivo bone marrow micronucleus test. Long term animal studies evaluating the carcinogenic potential have not been performed.
Danish: Gemcitabin er mutagen i en in vitro mutationstest og en in vivo knovlemarvs mikronukleustest.
English: Reconstitute 200 mg vials with 5 ml of 9 mg/ml (0.9 %) sterile sodium chloride solution for injection, without preservative, or 25 ml sterile sodium chloride solution for injection, without preservative to the 1000 mg vial.
Danish: Gemzar tilberedes ved at tilsætte 5 ml 9 mg/ml (0,9%) steril natriumchlorid injektionsvæske (uden konservering) til 200 mg hætteglasset eller 25 ml steril natriumchlorid injektionsvæske (uden konservering til 1000 g hætteglasset.
English: The recommended dose of gemcitabine is 1000 mg/m2, given by 30-minute intravenous infusion.
Danish: Den anbefalede dosis af gemcitabin er 1000 mg/m indgivet intravenøst over 30 minutter.
English: Eli Lilly ČR, s.r.o, Pobřežní 1A, , 186 00 Praha 8 Czech Republic
Danish: Eli Lilly ČR, s.r.o, Pobřežní 1A, , 186 00 Praha 8 Tjekkiet
English: Abnormal urine tests: protein in urine Flu like symptoms including fever Oedema (swelling of ankles, fingers, feet, face)
Danish: Unormale urinprøver: protein i urinen Influenzalignende symptomer inkl.
English: Eli Lilly ČR, s.r.o, Pobřežní 1A, 186 00 Praha 8 Czech Republic
Danish: Eli Lilly ČR, s.r.o, Pobřežní 1A, 186 00 Praha 8 Tjekkiet
English: After gemcitabine, carboplatin will be given on Day 1 consistent with a target Area under curve (AUC) of 4.0 mg/ml·min.
Danish: Carboplatin gives på dag 1 efter gemcitabin med en beregnet dosis ud fra Arealet under kurven (AUC) på 4,0 mg/ml i min. Dosisreduktion mellem hver cyklus eller i løbet af en cyklus baseres på den grad af toksicitet, som patienten oplever.
English: and or or
Danish: og eller eller
English: Eli Lilly ČR, s.r.o., Pobřežní 1a, 186 00 Praha 8 Czech Republic
Danish: Eli Lilly ČR, s.r.o., Pobřežní 1a, 186 00 Praha 8 Tjekkiet
English: Rare • Myocardial infarct
Danish: Sjældne bivirkninger Hjerteanfald
English: Grade 3 Grade 4 Grade 3 Grade 4
Danish: 4.4 og 4.5.
English: Gemzar 200 mg contains 3.5 mg (<1 mmol) sodium per vial.
Danish: Gemzar 200 mg indeholder 3,5 mg(<1 mmol) natrium pr. hætteglas.
English: Gemzar 1000 mg contains 17.5 mg (< 1 mmol) sodium per vial.
Danish: Gemzar 1000 mg indeholder 17,5 mg (<1 mmol) natrium pr. hætteglas.
English: • rare: affects 1 to 10 users in 10,000
Danish: • Sjældne bivirkninger: Forekommer hos mellem 1 og 10 ud af 10.000 patienter.
English: Further dilution with sterile sodium chloride 9 mg/ml (0.9 %) solution for injection, without preservative can be done.
Danish: Man kan fortynde yderligere med steril natriumklorid 9 mg/ml (0,9%) injektionsvæske, opløsning (uden konservering).
English: VIAL LABEL
Danish: Label til hætteglas
English: Therefore, men being treated with gemcitabine are advised not to father a child during and up to 6 months after treatment and to seek further advice regarding cryoconservation of sperm prior to treatment because of the possibility of infertility due to therapy with gemcitabine.
Danish: Det anbefales også at søge yderligere rådgivning angående kryokonservering af sæd før behandling, på grund af muligheden for infertilitet som følge af behandling med gemcitabin.
English: Each 1000 mg vial contains 17.5 mg (<1 mmol) sodium.
Danish: Hvert 1000 mg hætteglas indeholder 17,5 mg (<1 mmol) natrium.
English: The CHMP retained the conservative age of 18 and also noted that information regarding hepatic impairment was included and therefore requested the MAH to further discuss patients with renal or hepatic impairment and whether severe impairment had significant effect on gemcitabine pharmacokinetics.
Danish: CHMP anmodede derfor indehaveren af markedsføringstilladelsen om en yderligere redegørelse for patienter med nedsat nyre- eller leverfunktion og for, om en svært nedsat funktion har en væsentlig effekt på gemcitabins farmakokinetiske egenskaber.
English: BEFORE YOU ARE GIVEN GEMZAR
Danish: DET SKAL DE/DU VIDE, FØR DU BEGYNDER AT BRUGE GEMZAR
English: • uncommon: affects 1 to 10 users in 1,000
Danish: • Ikke almindelige bivirkninger: Forekommer hos mellem 1 og 10 ud af 1.000 patienter.
English: Gemcitabine in combination with paclitaxel is recommended using paclitaxel (175 mg/m2) administered on Day 1 over approximately 3-hours as an intravenous infusion, followed by gemcitabine (1250 mg/m2) as a 30-minute intravenous infusion on Days 1 and 8 of each 21-day cycle.
Danish: Brystcancer Kombinationsbehandling Gemcitabin i kombination med paclitaxel anbefales administreret på følgende måde: Den anbefalede dosis af paclitaxel er 175 mg/m indgivet intravenøst over ca. 3 timer på dag 1, efterfulgt af gemcitabin (1250
English: Dose modification of gemcitabine within a cycle for bladder cancer, NSCLC and pancreatic cancer, given in monotherapy or in combination with cisplatin Absolute granulocyte count (x 10
Danish: Dosisændring af gemcitabin givet som monoterapi eller i kombination med cisplatin i løbet af en cyklus ved blærecancer, ikke-småcellet lungecancer og pancreascancer Absolut granulocyttal (x 106/l)
English: Combination use in ovarian cancer
Danish: Kombinationsbehandling ved ovariecancer
English: If you would like to father a child during the treatment or in the 6 months following treatment, seek advice from your doctor or pharmacist.
Danish: Hvis du skulle ønske dette, bør du søge rådgivning hos lægen eller apoteket.
English: Clinical findings consistent with the haemolytic uraemic syndrome (HUS) were rarely reported in patients receiving gemcitabine (see section 4.8).
Danish: Ved behandling med gemcitabin er hæmolytisk-uræmisk syndrom (HUS) sjældent set (se pkt.
English: • Stomatitis and ulceration of the mouth
Danish: Kvalme, opkastning Diarré, stomatit og ulceration af mundslimhinden, obstipation
English: A statistically significant prolongation of the time to progression, from 4.3 to 6.9 months (p=0.014) was observed in patients treated with gemcitabine/cisplatin compared to patients treated with etoposide/cisplatin.
Danish: En statistisk signifikant forlængelse af tiden til progression fra 4,3 måneder med etoposid/cisplatin til 6,9 måneder med gemcitabin/cisplatin (p=0,014).
English: Gemzar is used in the treatment of the following types of cancer:
Danish: Gemzar bruges til behandling af: - Lungekræft, af typen ikke-småcellet.
English: Combination use
Danish: ANVENDELSESMÅDE
English: Adult Respiratory Distress Syndrome (severe lung inflammation causing respiratory failure) Radiation recall-(a skin rash like severe sunburn) which can occur on skin that has previously been exposed to radiotherapy.
Danish: Hud, der har været udsat for stråleterapi, kan få et udslæt, der ligner en alvorlig solskoldning (kaldes radiation recall).
English: Nervous system disorders
Danish: Sensorisk neuropati
English: Radiation toxicity (see section 4.5).
Danish: Strålingsskade (se pkt.
English: Regarding breast cancer, the MAH only proposed combination use for inclusion in the harmonised SPC, although a Phase 3 study showed the activity of single-agent gemcitabine for the treatment of metastatic breast cancer (MBC).The indication was supported by a clinical expert report and efficacy data from Phase 2 and 3 single-agent studies of Gemzar in the treatment of breast cancer, including studies conducted by the MAH and results from the published literature.
Danish: Hvad angår brystcancer, foreslog indehaveren af markedsføringstilladelsen kun, at kombinationsanvendelsen skulle med i det harmoniserede produktresumé, selvom en fase III-undersøgelse har påvist aktivitet af gemcitabin som enkeltstof til behandling af metastaserende brystcancer (MBC).
English: Concomitant radiotherapy
Danish: Samtidig røntgenbehandling
English: GROUNDS FOR AMENDMENT OF THE SUMMARIES OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET Whereas - the scope of the referral was the harmonisation of the Summaries of Products Characteristics, labelling and package leaflet.
Danish: - Formålet med indbringelsen af sagen var at harmonisere produktresumé, etikettering og indlægsseddel.
English: NAME OF THE MEDICINAL PRODUCT Gemzar 200 mg powder for solution for infusion Gemzar 1000 mg powder for solution for infusion Gemcitabine
Danish: LÆGEMIDLETS NAVN Gemzar 200 mg pulver til infusionsvæske, opløsning Gemzar 1000 mg pulver til infusionsvæske, opløsning Gemcitabin
English: consecutive weeks with therapeutic thoracic radiation to patients with non-small cell lung cancer, significant toxicity in the form of severe, and potentially life threatening mucositis, especially oesophagitis, and pneumonitis was observed, particularly in patients receiving large volumes of radiotherapy [median treatment volumes 4,795 cm3].
Danish: I en enkelt undersøgelse, hvor gemcitabin blev givet i en dosis på 1000 mg/m i op til 6 uger i træk sammen med terapeutisk torakalbestråling til patienter med ikke-småcellet lungecancer, blev der observeret signifikant toksicitet i form af svær og potentielt livstruende mucosit, specielt øsofagitis og pneumoni.
English: Patients should have an absolute granulocyte count of at least 1,500 (x 106/l) prior to initiation of gemcitabine + paclitaxel combination.
Danish: Patienterne bør have et absolut granulocyttal på mindst 1.500 (x 10
English: Powder for solution for infusion and intravesical instillation
Danish: Pulver til infusionsvæske, opløsning and intravesikal installation
English: Mean apparent clearance: 2.5 l/hr/m2 (range 1-4 l/hr/m2).
Danish: Gennemsnitlig påviselig clearance: 2,5 l/t/m
English: Excretion
Danish: Opkastning
English: Powder for Injection
Danish: Pulver til infusionsvæske, opløsning
English: Gemzar 1000 mg contains:
Danish: Gemzar 1000 mg indeholder: Mannitol.
English: NAME OF THE MEDICINAL PRODUCT Gemzar 200 mg powder for solution for infusion Gemzar 1000 mg powder for solution for infusion
Danish: LÆGEMIDLETS NAVN Gemzar 200 mg pulver til infusionsvæske, opløsning Gemzar 1000 mg pulver til infusionsvæske, opløsning
English: 200 mg Powder for solution for infusion and intravesical instillation
Danish: 200 mg Pulver til infusionsvæske, opløsning and intravesikal installation
English: If any of the side effects gets serious, or if you notice any side effects not mentioned in this leaflet, please tell your doctor.
Danish: Hvis du begynder at mærke nogle af disse bivirkninger, skal du hurtigst muligt fortælle det til din læge.
English: • Anaemia
Danish: Anæmi
English: Muscle pain
Danish: Muskelsmerter
English: Mannitol (E421)
Danish: Paclitaxel arm (N=259)
English: • pancreatic cancer.
Danish: - Kræft i bugspytkirtlen.
English: Blood and lymphatic system disorders
Danish: Blod og lymfesystem Meget almindelig ( 1/10)
English: Sodium acetate (E262)
Danish: Gemcitabin plus paclitaxel arm (N=262)
English: Pain, redness, swelling or sores in your mouth (common).
Danish: Knogler, led, muskler og bindevæv Almindelig ( 1/100 til <1/10)
English: Malta AM MANGION LTD.
Danish: AM MANGION LTD.
English: Stop taking Invokana and see a doctor as soon as possible if you have any of the following serious side effects:
Danish: Hold op med at tage Invokana, og kontakt lægen snarest muligt, hvis du får en af følgende alvorlige bivirkninger:
English: Adverse reactions in table 1 are based on the pooled analysis of the four 26-week placebo-controlled studies (n = 2,313) described above.
Danish: Bivirkningerne i tabel 1 er baseret på den puljede analyse af de fire placebo-kontrollerede studier fra uge 26 (n = 2.313) beskrevet ovenfor.
English: vaginal infection, vulvitis, and genital infection fungal.
Danish: vaginal infektion, vulvitis og genital svampeinfektion.
English: • Swallow the tablet whole with a half glass of water.
Danish: Sådan skal du tage medicinen • Synk tabletten hel med et halvt glas vand.
English: Patients had an overall mean age of 59.6 years (range 21 years to 96 years), with 3,082 patients ≥ 65 years of age and 510 patients ≥ 75 years of age.
Danish: Patienternes samlede gennemsnitsalder var 59,6 år (interval 21 år til 96 år), med 3.082 patienter i alderen ≥ 65 år og
English: To assess risk factors for these adverse reactions, a larger pooled analysis (N = 9,439) of patients from eight controlled phase 3 studies including both doses of canagliflozin was conducted.
Danish: Til vurdering af risikofaktorerne for disse bivirkninger blev der gennemført en større poolet analyse (N = 9.439) af patienter fra otte kontrollerede fase 3-studier, der omfattede begge doser canagliflozin.
English: Canagliflozin as add-on therapy to insulin (with or without other glucose-lowering medicinal products).
Danish: d Canagliflozin som tillægsbehandling til insulin (med eller uden andre glucosesænkende lægemidler).
English: • It is important to check your feet regularly and adhere to any other advice regarding foot care and adequate hydration given by your health care professional.
Danish: • Det er vigtigt, at du regelmæssigt kontrollerer dine fødder og overholder de retningslinjer for fodpleje og passende væskeindtagelse, som du får af lægen eller sundhedspersonalet.
English: In in vitro studies, canagliflozin neither inhibited cytochrome P450 CYP1A2,CYP2A6, CYP2C19, CYP2D6, or CYP2E1, CYP2B6, CYP2C8, CYP2C9, nor induced CYP1A2, CYP2C19, CYP2B6, CYP3A4 at higher than therapeutic concentrations.
Danish: I in vitro-studier udvirkede canagliflozin hverken hæmning af cytokrom P450 CYP1A2, CYP2A6, CYP2C19, CYP2D6 og CYP2E1, CYP2B6, CYP2C8 og CYP2C9 eller induktion af CYP1A2, CYP2C19, CYP2B6 eller CYP3A4 i koncentrationer over det terapeutiske niveau.
English: Consideration may also be given to stopping treatment with canagliflozin in patients that develop events preceding amputation such as lower-extremity skin ulcer, infection, osteomyelitis or gangrene.
Danish: Det kan også overvejes at afbryde behandlingen med canagliflozin hos patienter, der udvikler lidelser, der kan være forløbere for amputation, som f.eks. sår på underekstremitet, infektion, osteomyelitis eller gangræn.
English: Possible signs of losing too much fluid from your body are listed at the top of section 4 “Possible side effects”.
Danish: Se listen over symptomer på for stort væsketab fra kroppen øverst i punkt 4 “Bivirkninger”
English: Vulvovaginal candidiasis includes the terms vulvovaginal candidiasis, vulvovaginal mycotic infection, vulvovaginitis,
Danish: g Vulvovaginal candidiasis omfatter termerne vulvovaginal candidiasis, vulvovaginal svampeinfektion, vulvovaginitis,
English: • lower limb amputations (mainly of the toe) especially if you are at high risk of heart disease.
Danish: • amputation af en underekstremitet (primært en tå), især hvis du har høj risiko for hjertesygdom
English: Table 3: Efficacy results from active-controlled clinical studiesa
Danish: Tabel 3: Effektresultater fra aktivt kontrollerede kliniske studier a
English: In a pooled analysis of clinical data, increases in canagliflozin AUC of 26% were observed in UGT1A9*1/*3 carriers and 18% in UGT2B4*2/*2 carriers.
Danish: I en poolet analyse af kliniske data forekom der stigninger i canagliflozins AUC på 26 % hos UGT1A9*1/*3-bærere og 18 % hos UGT2B4*2/*2-bærere.
English: The primary assessment of safety and tolerability was conducted in a pooled analysis (n = 2,313) of four 26-week placebo-controlled clinical studies (monotherapy and add-on therapy with metformin, metformin and a sulphonylurea, and metformin and pioglitazone).
Danish: Den primære vurdering af sikkerhed og tolerabilitet udførtes som en poolet analyse (n = 2.313) af fire 26-ugers placebokontrollerede kliniske studier (som monoterapi og som tillægsbehandling til metformin, metformin og et sulfonylurinstof og metformin og pioglitazon).
English: Excipient(s) with known effect Each tablet contains 39.2 mg lactose.
Danish: Hjælpestof(fer), som behandleren skal være opmærksom på En tablet indeholder 39,2 mg lactose.
English: Mangion Building, Triq Ġdida fi Triq Valletta
Danish: Mangion Building, Triq Ġdida fi Triq Valletta MT-Ħal-Luqa LQA 6000
English: Compared to glimepiride as dual therapy with metformin (52 weeks) Canagliflozin + metformin Glimepiride (titrated) + metformin (N = 482)
Danish: Sammenlignet med glimepirid som dobbeltbehandling med metformin (52 uger) Canagliflozin + metformin Glimepirid (titreret) + metformin (N = 482)
English: Excipient(s) with known effect Each tablet contains 117.78 mg lactose.
Danish: Hjælpestof(fer), som behandleren skal være opmærksom på En tablet indeholder 117,78 mg lactose.
English: Use in patients at risk for adverse reactions related to volume depletion Due to its mechanism of action, canagliflozin, by increasing urinary glucose excretion (UGE) induces an osmotic diuresis, which may reduce intravascular volume and decrease blood pressure (see section 5.1).
Danish: Anvendelse til patienter med risiko for bivirkninger, der er forbundet med volumendepletering På grund af dets virkningsmekanisme, som øger udskillelse af glucose i urin (UGE), inducerer canagliflozin osmotisk diurese, hvilket kan reducere det intravaskulære volumen og sænke blodtrykket (se pkt.
English: In ongoing, long-term clinical studies of canagliflozin in type 2 diabetes patients with cardiovascular disease (CVD) or at high risk for CVD, an increase in cases of lower limb amputation (primarily of the toe) has been observed in patients treated with canagliflozin.
Danish: I igangværende kliniske langtidsstudier med canagliflozin hos patienter med type 2-diabetes og kardiovaskulær sygdom eller høj risiko for kardiovaskulær sygdom har der været observeret en stigning i antallet af amputationer af en underekstremitet (primært en tå) hos patienter, der fik canagliflozin.
English: Following co-administration of canagliflozin with rifampicin (an inducer of various active transporters and drug-metabolising enzymes), 51% and 28% decreases in canagliflozin systemic exposure (AUC)
Danish: Efter samtidig administration af canagliflozin og rifampicin (induktor af en række aktive transportører og lægemiddelmetaboliserende enzymer) blev der observeret fald på henholdsvis 51 % og 28 % i systemisk eksponering for canagliflozin (AUC) og maksimal plasmakoncentration (Cmax).
English: Table 1: Tabulated list of adverse reactions (MedDRA) from placebo-controlled studiesa and from postmarketing experience
Danish: Tabel 1: Bivirkninger (MedDRA) opstillet i tabelform på baggrund af placebokontrollerede studiera og erfaringer efter markedsføringen Systemorganklasse Hyppighed