natgillin/translations-raw huggingface dataset:
92% 58% 8%
92% 58% 8%
Det primære endpoint hos CP- patienterne var MCyR (major cytogenetisk respons) defineret som elimination (CCyR, complete cytogenetisk respons) eller signifikant reduktion til < 35% Ph+ metafaser (partiel cytogenetisk respons) af Ph+ hæmatopoietiske celler.
The primary endpoint in the CP patients was major cytogenetic response (MCyR), defined as elimination (CCyR, complete cytogenetic response) or significant reduction to < 35% Ph+ metaphases (partial cytogenetic response) of Ph+ haematopoietic cells.
CHR (complete hæmatologisk respons) hos CP- patienter blev evalueret som et sekundært endpoint.
Complete haematological response (CHR) in CP patients was evaluated as a secondary endpoint.
Det primære endpoint hos AP - patienterne var overordnet bekræftet hæmatologisk respons (HR) defineret som enten CHR, ingen tegn på leukæmi eller tilbagevenden til kronisk fase.
The primary endpoint in the AP patients was overall confirmed haematological response (HR), defined as either a complete haematological response, no evidence of leukaemia or return to chronic phase.
MCyR- raten hos 320 CP- patienter var 49%.
The MCyR rate in 320 CP patients was 49%.
De fleste respondenter opnåede deres MCyR hurtigt inden for 3 måneder (gennemsnitligt 2, 8 måneder) fra starten af Tasigna- behandlingen, og de blev
Most responders achieved their MCyR rapidly within 3 months (median 2.8 months) of starting Tasigna treatment and these were sustained (median duration has not been reached).
Af 156 patienter med MCyR mistede 43 patienter (27, 6%) deres MCyR.
Among 156 patients with MCyR 43 patients (27.6%) lost their MCyR.
Patienter med en CHR ved baseline opnåede en MCyR hurtigere (1 kontra 2, 8 måneder).
2.8 months).
Af CP- patienterne uden en baseline- CHR opnåede 70% en CHR, og den gennemsnitlige tid til CHR var 1 måned, og den gennemsnitlige varighed af CHR er ikke nået.
Of CP patients without a baseline CHR, 70% achieved a CHR and median time to CHR was 1 month and median duration of CHR has not been reached.
Den overordnede bekræftede HR- rate hos 119 AP- patienter var 42%.
11 The overall confirmed HR rate in 119 AP patients was 42%.
De fleste respondenter nåede en HR tidligt med Tasigna- behandling (gennemsnit 1, 0 måned), og de har været vedvarende (gennemsnitsvarighed ikke nået).
Most responders achieved a HR early with Tasigna treatment (median 1.0 months) and these have been durable (median duration has not been reached).
Ingen patienter har mistet CHR.
No patients have had a loss of CHR.
MCyR- raten var 27% med en gennemsnitlig tid til respons på 2, 0 måneder.
The MCyR rate was 27% with a median time to response of 2.0 months.
Responsraterne for de to behandlingsarme er anført i tabel 7.
The rates of response for the two treatment arms are reported in Table 7.
Respons hos CML
Response in CML
(bedste responsrate)
(Best Response Rate)
Kronisk fase
Chronic Phase
Intolerant (n=94)
Intolerant (n=94)
Total (n=320)
Total (n=320)
Total (n=119)
Total (n=119)
Overordnet (95% CI)
Overall (95%CI)
Fuldstændig NEL Tilbage til CP Cytogenetisk respons (%)
Complete NEL Return to CP Cytogenetic Response (%)
Større (95% CI) Komplet Partiel
Major (95%CI) Complete Partial NEL = no evidence of leukaemia/ marrow 1
NEL = ingen tegn på leukæmi - / marvrespons 1 114 CP- patienter havde en CHR ved baseline og kunne derfor ikke vurderes med henblik på fuldstændig hæmatologisk respons
114 CP patients had a CHR at baseline and were therefore not assessable for complete haematological response
Effektdata fra patienter med CML- BC er endnu ikke tilgængelige.
Efficacy data in patients with CML-BC are not yet available.
Der var også inkluderet separate behandlingsarme i fase II- studiet for at undersøge Tasigna på en gruppe CP - og AP- patienter, som havde fået ekstensiv tidligere behandling, inkl. et tyrosinkinasehæmmende stof, ud over imatinib.
Separate treatment arms were also included in the Phase II study to investigate Tasigna in a group of CP and AP patients who had been extensively pre-treated with multiple therapies including a tyrosine kinase inhibitor agent in addition to imatinib.
Af disse patienter var 30/ 36 (83%) behandlingsresistente, ikke intolerante.
Of these patients 30/ 36 (83%) were treatment resistant not intolerant.
Hos 22 CP- patienter, der blev evalueret med henblik på virkning, inducerede Tasigna en MCyR- rate på 32% og en CHR- rate på 50%.
In 22 CP patients evaluated for efficacy Tasigna induced a 32% MCyR rate and a 50% CHR rate.
Hos 11 AP- patienter, der blev evalueret med henblik på virkning, inducerede behandlingen en overordnet HR- rate på 36%.
In 11 AP patients, evaluated for efficacy, treatment induced a 36% overall HR rate.
Efter imatinib- svigt blev 24 forskellige Bcr- Abl- mutationer noteret hos 45% af de CML- CP- patienter og 57% af de CML- AP- patienter, som blev evalueret med henblik på mutationer.
After imatinib failure, 24 different Bcr-Abl mutations were noted in 45% of chronic phase and 57% of accelerated phase CML patients who were evaluated for mutations.
Tasigna viste virkning hos patienter med forskellige Bcr- Abl- mutationer, der associeres med imatinib- resistens, undtagen T315I.
Tasigna demonstrated efficacy in patients harboring a variety of Bcr-Abl mutations associated with imatinib resistance, except T315I.
Absorption Maksimumkoncentrationerne af nilotinib nås 3 timer efter oral administration.
Absorption Peak concentrations of nilotinib are reached 3 hours after oral administration.
Nilotinib- absorptionen efter oral administration var omkring 30%.
Nilotinib absorption following oral administration was approximately 30%.
Hos raske frivillige forsøgspersoner er Cmax og arealet under serumkoncentrationstidskurven (AUC) for nilotinib øget med henholdsvis 112% og 82% sammenlignet med fastende, når Tasigna gives sammen med mad.
In healthy volunteers, Cmax and area under the serum concentration-time curve (AUC) of nilotinib are increased by 112% and 82%, respectively, compared to fasting conditions when Tasigna is given with food.
4. 2, 4. 4 og 4. 5).
Administration of Tasigna 30 minutes or 2 hours after food increased bioavailability of nilotinib by 29% or 15%, respectively (see sections 4.2, 4.4 and 4.5).
Fordeling Nilotinibs blod- plasma- ratio er 0, 71.
Distribution The blood-to-plasma ratio of nilotinib is 0.71.
98%.
Plasma protein binding is approximately 98% on the basis of in vitro experiments.
12 Biotransformation De vigtigste metaboliseringsveje hos raske forsøgspersoner er oxidering og hydroxylering.
Biotransformation Main metabolic pathways identified in healthy subjects are oxidation and hydroxylation.
Udskillelse Efter en enkeltdosis af radioaktivt mærket nilotinib hos raske forsøgspersoner var mere end 90% af dosis elimineret inden 7 dage, hovedsageligt i fæces (94% af dosis).
12 Elimination After a single dose of radiolabelled nilotinib in healthy subjects, more than 90% of the dose was eliminated within 7 days, mainly in faeces (94% of the dose).
Det oprindelige lægemiddel udgjorde 69% af dosis.
Parent drug accounted for 69% of the dose.
Linearitet/ non- linearitet Nilotinib- eksponeringen ved steady state var dosisafhængig med mindre end dosisproportionale stigninger i den systemiske eksponering ved dosisniveauer på over 400 mg givet som én daglig dosis.
Linearity / non-linearity Steady-state nilotinib exposure was dose-dependent, with less than dose-proportional increases in systemic exposure at dose levels higher than 400 mg given as once-daily dosing.
Den daglige serumeksponering for nilotinib med 400 mg to gange dagligt ved steady state var 35% højere end med 800 mg en gang dagligt.
Daily serum exposure to nilotinib with 400 mg twice-daily dosing at steady state was 35% higher than with 800 mg once-daily dosing.
Der var ingen relevant stigning i eksponeringen for nilotinib, når dosisblev øget fra 400 mg to gange dagligt til 600 mg to gange dagligt.
There was no relevant increase in exposure to nilotinib when the dose was increased from 400 mg twice daily to 600 mg twice daily.
Karakteristika hos patienten Steady state- tilstand blev i alt væsentligt nået ved dag 8.
Characteristics in patients Steady-state conditions were essentially achieved by day 8.
En stigning i serumeksponering for nilotinib mellem den første dosis og steady state var 2 gange for en daglig dosering og 3, 8 gange for to daglige doseringer.
An increase in serum exposure to nilotinib between the first dose and steady state was approximately 2-fold for daily dosing and 3.8-fold for twice-daily dosing.
17 timer.
The apparent elimination half-life estimated from the multiple-dose pharmacokinetics with daily dosing was approximately 17 hours.
Patientvariationerne i nilotinib- farmakokinetikken var moderat til høj.
Inter-patient variability in nilotinib pharmacokinetics was moderate to high.
Nilotinib er evalueret i studier af sikkerhedsfarmakologi, gentagen dosis- toksicitet, genotoksicitet, reproduktiv toksicitet og fototoksicitet.
Nilotinib has been evaluated in safety pharmacology, repeated dose toxicity, genotoxicity, reproductive toxicity and phototoxicity studies.
Nilotinib havde ingen indvirkning på CNS - eller respirationsfunktionerne.
Nilotinib did not have effects on CNS or respiratory functions.
In vitro - hjertesikkerhedsstudier viste et præklinisk signal for QT- forlængelse baseret på blokering af hERG - kanalen og forlængelse af aktionspotentialets varighed i isolerede kaninhjerter med nilotinib.
In vitro cardiac safety studies demonstrated a preclinical signal for QT prolongation, based upon block of hERG currents and prolongation of the action potential duration in isolated rabbit hearts by nilotinib.
Der sås ingen virkning på EKG- målinger af hunde eller aber, der havde modtaget behandling i op til 39 uger, eller i et særligt telemetristudie af hunde.
No effects were seen in ECG measurements in dogs or monkeys treated for up to 39 weeks or in a special telemetry study in dogs.
Studier af gentagen dosis- toksicitet hos hunde af op til 4 ugers varighed og hos cynomolgusaber af op til 9 måneders varighed viste leveren som det primære målorgan for nilotinibs toksicitet.
Repeated-dose toxicity studies in dogs of up to 4 weeks’ duration and in cynomolgus monkeys of up to 9 months’ duration revealed the liver as the primary target organ of toxicity of nilotinib.
Ændringer inkluderede øget alaninaminotransferase og alkalifosfataseaktivitet og histopatologiske fund (hovedsageligt sinusoidecelle - eller Kupffer- cellehyperplasi/ hypertrofi, galdegangshyperplasi og periportal fibrose).
Alterations included increased alanine aminotransferase and alkaline phosphatase activity and histopathology findings (mainly sinusoidal cell or Kupffer cell hyperplasia/ hypertrophy, bile duct hyperplasia and periportal fibrosis).
Generelt var ændringerne i den kliniske kemi fuldt reversible efter en fire- ugers restitutionsperiode, og de histologiske ændringer viste partiel reversibilitet.
In general the changes in clinical chemistry were fully reversible after a four-week recovery period and the histological alterations showed partial reversibility.
Eksponeringerne ved de laveste dosisniveauer, hvor levervirkningerne sås, var lavere end eksponeringen hos mennesker ved en dosis på 800 mg/ dag.
Exposures at the lowest dose levels at which the liver effects were seen were lower than the exposure in humans at a dose of 800 mg/ day.
Genotoksicitetsstudier i bakterielle in vitro- systemer og i in vitro - og in vivo- systemer hos pattedyr med og uden metabolisk aktivering viste ingen tegn på mutagent potentiale hos nilotinib.
Genotoxicity studies in bacterial in vitro systems and in mammalian in vitro and in vivo systems with and without metabolic activation did not reveal any evidence for a mutagenic potential of nilotinib.
Nilotinib inducerede ikke teratogenicitet, men viste embryo - og føtotoksicitet ved doser, der også viste maternel toksicitet.
Nilotinib did not induce teratogenicity, but did show embryo- and foetotoxicity at doses that also showed maternal toxicity.
Embryotoksicitetsstudierne påviste embryoletaliteten og de føtale virkninger (hovedsageligt reduceret fostervægt, præmatur fusion af ansigtsknogler (sammenvokset maxilla/ arcus zygomaticus) og viscerale og skeletale variationer) hos rotter og øget resorption af fostre og skeletvariationer hos kaniner.
Embryo-lethality and foetal effects (mainly decreased foetal weights, premature fusion of the facial bones (fused maxilla/ zygomatic) visceral and skeletal variations) in rats and increased resorption of foetuses and skeletal variations in rabbits were present in the embryotoxicity studies.
I et præ - og postnatalt udviklingsstudie hos rotter forårsagede maternal eksponering over for nilotinib reduceret kropsvægt hos ungerne og deraf følgende forandringer i de fysiske
In a pre- and postnatal development study in rats, maternal exposure to nilotinib caused reduced pup body weight with associated changes in physical development parameters as well as reduced mating and fertility indices in the offspring.
Eksponering for nilotinib hos hunner ved NOAEL var generelt mindre end eller lig med eksponeringen hos mennesker ved 800 mg/ dag.
Exposure to nilotinib in females at No-Observed- Adverse-Effect-Levels was generally less or equal to that in humans at 800 mg/ day.
5 gange højere end den anbefalede dosis for mennesker.
No effects on sperm count/ motility or on fertility were noted in male and female rats up to the highest tested dose, approximately 5 times the recommended dosage for humans.
Nilotinib fordeles ind i huden og viste et fototoksisk potentiale in vitro, men der er ikke observeret nogen virkninger in vivo.
13 Nilotinib was shown to absorb light in the UV-B and UV-A range, is distributed into the skin and showed a phototoxic potential in vitro, but no effects have been observed in vivo.
Der er ikke udført karcinogenitetsstudier med nilotinib.
Carcinogenicity studies with nilotinib have not been performed.
Lactosemonohdyrat Crospovidon Poloxamer 188 Silica, kolloid vandfri/ siliciumdioxid Magnesiumstearat
Lactose monohydrate Crospovidone Poloxamer 188 Silica colloidal, anhydrous/ Colloidal silicon dioxide Magnesium stearate
Gelatine Titandioxid (E 171) Jernoxid, gul (E 172)
Gelatin Titanium dioxide (E171) Yellow iron oxide (E172)
Shellak Rød jernoxid (E 172) Soyalecithin (E 322)
Shellac Red iron oxide (E172) Soya lecithin (E322)
PVC/ PVDC/ Al - og PA/ Al/ PVC/ Al - blister.
PVC/ PVDC/ Al and PA/ Al/ PVC/ Al blisters.
Tasigna fas i uge - og månedspakninger. • Ugepakningen indeholder 28 kapsler. • Månedspakningen indeholder 112 kapsler (4x28).
Tasigna is available in weekly and monthly packs: • The weekly pack contains 28 capsules. • The monthly pack contains 112 capsules (4x28).
En månedspakning består af 4 individuelle ugepakninger.
A monthly pack consists of 4 individual weekly wallets.
14 Ikke alle pakningsstørrelser er nødvendigvis markedsført.
14 7.
Kort baggrundsinformation om Tasigna, den godkendte indikation og dosering Information om de kardiovaskulære risici der er forbundet med anvendelsen af Tasigna o At Tasigna kan forårsage forlængelse af QT- intervallet, og at patienter med risiko for arrytmier, specielt torsade de pointes, ikke bør udskrives Tasigna o Nødvendigheden af at undgå samtidig udskrivning af lægemidler som muligvis forlænger QT- intervallet o Forsigtighed ved udskrivning til patienter med risikofaktorer for hjertekarsygdom eller tidligere hjertekarsygdom o At Tasigna kan forårsage væskeretention, hjertesvigt og pulmonært ødem.
• Brief background on Tasigna, its authorised indication and posology • Information on the cardiac risks associated with the use of Tasigna o That Tasigna can cause prolongation of the QT interval and that patients at risk of arrythmia, especially torsade de pointes, should not be prescribed Tasigna. o The need to avoid co-prescription with any other medicines that might prolong the QT interval o Caution in prescribing to patients with a history of or risk factors for coronary heart disease o That Tasigna may cause fluid retention, cardiac failure and pulmonary oedema
At Tasigna bliver metaboliseret af CYP3A4, og at stærke inhibitorer eller inducere af dette enzym kan påvirke eksponeringen for Tasigna signifikant o At hæmmere kan øge risikoen for bivirkninger, specielt forlængelse af QT- intervallet o At advare patienter mod håndkøbsmedicin, specielt prikbladet perikum
• That Tasigna is metabolised by CYP3A4 and that strong inhibitors or inducers of this enzyme may significantly affect exposure to Tasigna. o That inhibitors may increase the potential for adverse drug reactions in particular QT interval prolongation. o To warn patients about OTC medicines in particular St John’ s Wort
Nødvendigheden af at informere patienterne om fødevarers effekt på Tasigna o Ikke at spise inden for 2 timer før og 1 time efter indtagelse af Tasigna o Nødvendigheden af at undgå fødevarer som grapejuice, der hæmmer CYP3A4- enzymer
• The need to inform patients about the effects of food on Tasigna o Not to eat within two hours before and one hour after taking Tasigna o The need to avoid foods such as grapefruit juice which inhibit CYP3A4 enzymes
17 • ANDRE BETINGELSER
17 • OTHER CONDITIONS
Indehaveren af markedsføringstilladelsen skal sikre at pharmacovigilancesystemet, som beskrevet i version 2, dateret 23- okt- 06, præsenteret i Modul 1. 8. 1. af ansøgningen om markedsføringstilladelse, er på plads og fungerer, før og mens produktet er på markedet.
The MAH must ensure that the system of pharmacovigilance, as described in version 2, dated 23-Oct-06, presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Indehaveren af markedsføringstilladelsen forpligter sig til at udføre de studier og yderligere pharmacovigilanceaktiviteter beskrevet i pharmacovigilanceplanen, som aftalt i version 2, dateret 19- sep- 07, af Risk Management Planen (RMP) præsenteret i Modul 1. 8. 2. af ansøgningen om markedsføringstilladelsen og efterfølgende opdateringer til RMPen aftalt med CHMP.
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 2, dated 19-Sep-07 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
ÆSKE MED UGEPAKNING
CARTON OF WEEKLY PACK
Tasigna 200 mg hårde kapsler Nilotinib
Tasigna 200 mg hard capsules Nilotinib
ÆSKE MED MÅNEDSPAKNING
CARTON OF MONTHLY PACK
112 hårde kapsler Månedspakning med 4 ugepakninger.
112 hard capsules Monthly pack containing 4 wallets.
FREMSTILLERS NUMMER
BATCH NUMBER
UGEPAKNINGER I MÅNEDSPAKNING
INTERMEDIATE WALLET OF MONTHLY PACK
28 hårde kapsler Delpakning af månedspakning med 4 ugepakninger.
28 hard capsules Component of a monthly pack containing 4 wallets.
- Lægen har ordineret Tasigna til dig personligt.
- This medicine has been prescribed for you.
Tasignas virkning, og hvad du skal bruge det til 2.
What Tasigna is and what it is used for 2.
Det skal du vide, før du begynder at tage Tasigna 3.
Before you take Tasigna 3.
Sådan skal du tage Tasigna 4.
How to take Tasigna 4.
Sådan opbevarer du Tasigna 6.
How to store Tasigna 6.
TASIGNAS VIRKNING, OG HVAD DU SKAL BRUGE DET TIL
WHAT TASIGNA IS AND WHAT IT IS USED FOR
Hvad du skal bruge Tasigna til Tasigna bruges til at behandle en form for leukæmi, der hedder Philadelphia- kromosompositiv kronisk myeloid leukæmi (Ph- positiv CML).
What Tasigna is used for Tasigna is used to treat a type of leukaemia called Philadelphia chromosome positive chronic myeloid leukaemia (Ph-positive CML).
Tasigna bruges til patienter med CML, som ikke længere har gavn af tidligere behandling, herunder behandling med imatinib.
Tasigna is used in patients with CML who are no longer benefiting from previous treatment including imatinib.
Sådan virker Tasigna Hos patienter med CML udløser en ændring i DNA (arvematerialet) et signal, der fortæller kroppen, at den skal producere unormale hvide blodlegemer.
How Tasigna works In patients with CML, a change in DNA (genetic material) triggers a signal that tells the body to produce abnormal white blood cells.
Overvågning af din Tasigna- behandling Du får foretaget regelmæssige undersøgelser, herunder taget blodprøver, under behandlingen.
Monitoring your Tasigna treatment You will have regular tests, including blood tests, during treatment.
Blodprøverne overvåger mængden af blodceller (hvide blodlegemer, røde blodlegemer og blodplader) i kroppen, så man kan se, hvordan du tåler Tasigna.
These will monitor the amount of blood cells (white blood cells, red blood cells and platelets) in your body to see how Tasigna is tolerated.
DET SKAL DU VIDE, FØR DU BEGYNDER AT TAGE TASIGNA
BEFORE YOU TAKE TASIGNA
Følg alle lægens anvisninger omhyggeligt.
Follow all the doctor’ s instructions carefully.
29 Tag ikke Tasigna
29 Do not take Tasigna
- hvis du er overfølsom (allergisk) over for nilotinib eller et af de øvrige indholdsstoffer i
- if you are allergic (hypersensitive) to nilotinib or any of the other ingredients of Tasigna listed
Tasigna, som er anført i slutningen af denne indlægsseddel.
at the end of this leaflet.
Vær ekstra forsigtig med at tage Tasigna
Take special care with Tasigna
- hvis du har en hjertesygdom, f. eks. et unormalt elektrisk signal kaldet ” QT- forlængelse ”.
- if you have a heart disorder, such as an abnormal electrical signal called “ prolongation of the
- hvis du bliver behandlet med medicin, der påvirker hjerterytmen (antiarytmika) eller leveren
- if you are being treated with medicines that affect the heart beat (anti-arrhythmics) or the liver
(se Brug af anden medicin).
(see Taking other medicines).
- hvis du lider af kalium - eller magnesiummangel.
- if you suffer from lack of potassium or magnesium.
- hvis du er blevet behandlet med en medicin af typen antracykliner (bruges ofte til behandling af
- if you have been treated with a medicine of the type called anthracyclines (frequently used in
leukæmi).
leukaemia therapy).
- hvis du bliver behandlet med medicin, der påvirker din mavesyre (se Brug af anden medicin).
- if you are being treated with medicines that affect your stomach acidity (see Taking other
Brug af anden medicin Tasigna kan påvirke visse andre lægemidler.
Taking other medicines Tasigna may interfere with some other medicines.
Dette gælder også medicin, som ikke er købt på recept.
Tell your doctor or pharmacist before taking Tasigna if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Det gælder især: • antiarytmika – bruges til at behandle uregelmæssig hjerterytme • chloroquin, halofantrin, clarithromycin, haloperidol, methadon – lægemidler, der kan have en uønsket virkning på hjertets funktion • ketoconazol, itraconazol, voriconazol, moxifloxacin, clarithromycin, telithromycin – bruges til at behandle infektioner • ritonavir – lægemiddel fra klassen ” antiproteaser ”, der bruges til at behandle HIV • carbamazepin, phenobarbital, phenytoin – bruges til at behandle epilepsi • rifampicin – bruges til at behandle tuberkulose • prikbladet perikum – et urteprodukt, der bruges til at behandle depression og andre tilstande (kaldes også Hypericum perforatum) • midazolam – bruges til at afhjælpe angst før en operation • warfarin – bruges til at behandle sygdomme, hvor blodet størkner (f. eks. blodpropper eller tromboser) • astemizol, terfenadin, cisaprid, pimozid, quinidin, bepridil eller ergotalkaloider (ergotamin, dihydroergotamin) • antacida, H2- blokkere, protonpumpehæmmere – bruges til at hæmme/ neutralisere mavesyren.
John’ s Wort – a herbal product used to treat depression and other conditions (also known as Hypericum perforatum); • midazolam – used to relieve anxiety before surgery; • warfarin – used to treat blood coagulation disorders (such as blood clots or thromboses); • astemizole, terfenadine, cisapride, pimozide, quinidine, bepridil or ergot alkaloids (ergotamine, dihydroergotamine); • antacids, H2 blockers, proton pump inhibitors – used to suppress stomach acidity.
Hvis du tager nogle af disse lægemidler, kan din læge ordinere andre alternative midler.
If you are taking any of these, your doctor might prescribe other alternative medicines.