FrancophonIA/ELRC3.0 huggingface dataset:
English: Steady-state concentrations are already reached after administration of the second Nifedipine Pharmamatch retard tablet.
Danish: Steady-state koncentrationer er allerede nået efter administration af den anden Nifedipine Pharmamatch retard tablet.
English: Subsequent titration to a higher dose may be initiated as warranted clinically
Danish: Efterfølgende titrering til en højere dosis kan indledes med klinisk garanti.
English: Whenever this is the case, the treating physician should be notified immediately, and treatment with nifedipine should be ceased.
Danish: Når det er tilfældet, skal den behandlende læge orienteres med det samme og behandlingen med nifedipin skal stoppes.
English: The two main metabolites are the pyridine-3-carbonic acid metabolite and a 2-hydroxymethylpyridine-3-carbonic acid metabolite or, depending on the pH, its lacton form.
Danish: De to hovedmetabolitter er pyridin-3-carbonisk syremetabolit og en 2-hydroxymethyl-pyridin3-carbonisk syremetabolit eller, afhængigt af pH-værdien, dens lactonform.
English: Nifedipine should not be used by women who intend to get pregnant in the near future (see section 4.4).
Danish: Nifedipin bør ikke anvendes af kvinder, der overvejer at blive gravide i den nærmeste fremtid (se afsnit 4.4).
English: Haemodialysis is not useful, since nifedipine cannot be dialysed.
Danish: Hæmodialyser er ikke nyttigt, da nifedipin ikke kan dialyseres.
English: BATCH NUMBER Batch no.:
Danish: FREMSTILLERENS BATCHNUMMER Batch nr.:
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS STRIPS
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ BLISTERKORT ELLER BLISTER STRIPS
English: Nifedipine undergoes a first pass metabolism in the liver of 30-40%.
Danish: Nifedipin gennemgår en first-pass-metabolisme i leveren af 30-40%.
English: Moreover, as is the case for all oral administrations, the active substance undergoes a first pass effect.
Danish: Desuden gennemgår det aktive stof en first-pass-effekt, som det er tilfældet med alle orale administrationer.
English: Symptomatic treatment of chronic stable angina pectoris as monotherapy or in combination with a beta-blocker.
Danish: Symptomatisk behandling af kronisk stabil angina pectoris som eneste behandling eller sammen med en beta-blokker.
English: 4.4 Special warnings and special precautions for use In exceptional cases, the use of nifedipine can lead to severe complaints of angina pectoris, probably due to fast resorption and an overly abrupt decrease in blood pressure.
Danish: 4.4 Særlige advarsler og forsigtighedsregler vedrørende brugen I sjældne tilfælde kan brug af nifedipin medføre alvorlige problemer med angina pectoris, sandsynligvis pga. hurtig resorption og et ekstremt pludseligt fald i blodtrykket.
English: It is a fact that there are nifedipine products on the EU market which are not contraindicated neither in pregnancy nor in women capable of child bearing.
Danish: Det er et faktum, at der på EU-markedet findes nifedipine-produkter, som hverken er kontraindicerede under graviditet eller for kvinder i den fødedygtige alder.
English: Some studies reveal increased plasma concentrations of nifedipine in case of co-administration with quinidine, though others revealed no effects on the pharmacokinetic properties of nifedipine.
Danish: Nogle undersøgelser viser øgede plasmakoncentrationer af nifedipin i tilfælde af samtidig administration med quinidin, selvom andre ikke viste nogle effekter på nifedipins farmakokinetiske egenskaber.
English: Cardiac effects may include heart block, AV dissociation and asystole, and cardiogenic shock with pulmonary oedema.
Danish: kardiale effekter kan inkludere hjerteblok, AV-dissociation og asystoli (hjertestop) og kardiogent chok med pulmonært ødem.
English: Nifedipine is a calcium antagonist and has a spasmolytic effect on the vascular wall of mainly coronary arteries.
Danish: Nifedipin er en calciumantagonist og har en spasmolytisk effekt på den vaskulære væg af hovedsagligt coronararterierne.
English: Nifedipine can cause dizziness, headache, fatigue or nausea, especially at the beginning of therapy, after a change in your medication or when consumed with alcohol.
Danish: Nifedipin kan medføre svimmelhed, hovedpine, træthed eller kvalme, især i begyndelsen af behandlingen, efter ændring af Deres medicinering eller når det indtages sammen med alkohol.
English: ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARIES OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET PRESENTED BY THE EMEA
Danish: BILAG II FAGLIGE KONKLUSIONER OG BEGRUNDELSER FOR ÆNDRING AF PRODUKTRESUMEER, ETIKETTERING OG INDLÆGSSEDLER FREMLAGT AF EMEA
English: In conclusion, the benefit/risk ratio favours the opinion that the use of nifedipine should not be contraindicated for women capable of childbearing or for nursing women.
Danish: Det konkluderes, at benefit/risk-forholdet begunstiger den opfattelse, at nifedipine til kvinder i den fødedygtige alder eller til ammende kvinder ikke bør kontraindiceres.
English: Use in children Nifedipine is not recommended for use in children
Danish: Brug hos børn Nifedipin anbefales ikke til børn
English: - The scope of the referral was to agree whether nifedipine should be contraindicated for women capable of childbearing or for nursing women and to amend the Summary of Products Characteristics in view of the available safety data
Danish: - formålet med henvisningen var at opnå enighed om, hvorvidt nifedipine bør kontraindiceres til kvinder i den fødedygtige alder og til ammende kvinder, og at ændre produktresuméet på grundlag af de foreliggende oplysninger om sikkerhed,
English: As a result of the relaxation of arterial muscle, nifedipine reduces peripheral resistance, leading to an improvement of peripheral blood flow whilst decreasing after-load.
Danish: Som et resultat af afslapning af arteriemusklen, reducerer nifedipin den perifere resistens og medfører en forbedring af det perifere blodomløb, mens afterload reduceres.
English: Nifedipine may increase the spectrophotometric values of urinary vanillylmandelic acid falsely.
Danish: Nifedipin kan give en falsk forøgelse af de spektrofotometriske værdier i den vanillylmandeliske syre i urinen.
English: Nifedipine can aggravate an existing decompensatio cordis in: patients with an obstruction of the out-flow tract, in which an increase of the gradient of the decompensation sometimes occurs (e.g. aorta stenosis) (See section 4.3); patients with a right-sided decompensatio cordis, in which in some cases a decrease of cardiac output, accompanied with increased fluid retention, occurs.
Danish: Nifedipin kan forværre en eksisterende decompensatio cordis hos: patienter med en obstruktion i outflow tract, hvori der sommetider opstår en forøgelse af stigningen af dekompensationen (f.eks. aorta stenose) (Se afsnit 4.3); patienter med en decompensatio cordis i højre side, hvor der i nogle tilfælde sker et fald i hjertets minutvolumen sammen med en øget væskeretention.
English: gynaecomastia in men over 50 years; reversible at discontinuation of treatment.
Danish: gynaekomasti hos mænd over 50 år; reversibel ved seponering af behandlingen.
English: atrophic endometrium.
Danish: atrofisk endometrium
English: Nifedipine Pharmamatch retard should neither be prescribed to patients with Kock pouch (ileostomy after proctocolectomy).
Danish: Nifedipine Pharmamatch retard må heller ikke forskrives patienter med Kock pouch (ileostomi efter proctocolectomi).
English: In patients with hepatic impairment, the elimination half-life is distinctly prolonged and the total clearance is reduced.
Danish: Hos patienter med leverlidelser er udskillelseshalveringstiden klart forlænget og den totale clearance er reduceret.
English: It is not recommended to drink grapefruit juice when treated with Nifedipine Pharmamatch retard.
Danish: Det anbefales ikke at drikke grapefrugtjuice, når De behandles med Nifedipine Pharmamatch retard.
English: Nifedipine is contraindicated during pregnancy (See section 4.3).
Danish: Nifedipin er kontraindikeret under graviditeten (Se afsnit 4.3).
English: Nifedipine can worsen an existing decompensatio cordis.
Danish: Nifedipin kan forværre en eksisterende decompensatio cordis.
English: In case of doubt, always contact your doctor or pharmacist.
Danish: I tvivlstilfælde skal De altid spørge Deres læge eller apotek.
English: Nifedipine Pharmamatch retard is formulated in such way that it releases the active substance in the intestine with a practically constant rate over a 16 to 18 hour time period.
Danish: Nifedipine Pharmamatch retard er formuleret således, at det aktive stof frigives i tarmen med praktisk konstant frekvens over en periode på 16 til 18 timer.
English: In case of co-administration of nifedipine with β-blocking medicines, the patient should be carefully monitored, since severe hypotension can occur.
Danish: I tilfælde af samtidig administration af nifedipin med β-blokker-medikamenter, bør patienten nøje monitoreres da der kan forekomme alvorlig hypotension.
English: The intake of grapefruit juice during treatment with nifedipine is discouraged (see also section 5.2).
Danish: Indtagelsen af grapefrugtjuice i løbet af behandlingen med nifedipin frarådes (se også afsnit 5.2).
English: The safety of nifedipine during pregnancy has not been established.
Danish: Sikkerheden ved nifedipin under graviditet er ikke påvist.
English: Some of these substances, like fluoxetine, indinavir and ritonavir, have been demonstrated to inhibit the CYP3A4 mediated metabolism of nifedipine in vitro.
Danish: Nogle af disse stoffer, som fluoxetin, indinavir og ritonavir, har vist sig at hæmme CYP3A4-formidlet metabolisme af nifedipin in vitro.
English: oesophageal reflux in patients with systemic sclerosis, allergic hepatitis, increased portal pressure in patients with alcoholic cirrhosis, transient increase in liver enzymes.
Danish: oesophageal reflux hos patienter med systemisk sclerose, allergisk hepatitis, øget portalt tryk hos patienter med alkoholinduceret cirrhose, forbigående forøgelse af leverenzymer.
English: Other interactions with nifedipine
Danish: Andre interaktioner med nifedipin:
English: There are situations when other treatment alternatives are not suitable or where calcium antagonists are appropriate to include in a combination of different drugs after careful benefit/risk evaluation.
Danish: Det kan forekomme, at andre behandlingsalternativer ikke er egnede, eller at calciumantagonister godt kan administreres sammen med andre lægemidler efter nøje evaluering af benefit/risk-forholdet.
English: The number of severe adverse events, as well as the number of reported metabolism-related adverse events such as hypokalaemia, hyponatraemia and hyperuremia, was lower in the group treated with nifedipine.
Danish: Antallet af alvorlige bivirkninger samt antallet af rapporterede metabolismerelaterede bivirkninger, så som hypokalæmi, hyponatræmi og hyperuremi, var lavere i den gruppe, der blev behandlet med nifedipin.
English: In such an event, you should stop taking Nifedipine Pharmamatch retard and contact your doctor.
Danish: I et sådan tilfælde skal De stoppe med at tage Nifedipine Pharmamatch retard og kontakte Deres læge.
English: Caution should be exercised when nifedipine is co-administered with intravenous magnesium sulphate.
Danish: Der bør udvises forsigtighed, når nifedipin administreres samtidigt med intravenøst magnesiumsulfat.
English: OTHER SPECIAL WARNING(S), IF NECESSARY Contains lactose.
Danish: EVENTUELLE ANDRE SÆRLIGE ADVARSLER Indeholder lactose.
English: The treating physician decides on the duration of treatment.
Danish: Den behandlende læge afgør behandlingens varighed.
English: Preferably the tablets are administered in the morning with a glass of water (no grapefruit juice; see also section 4.5).
Danish: Tabletterne bør helst tages om morgenen med et glas vand (ingen grapefrugtjuice; se også afsnit 4.5).
English: Cardiogenic shock, clinically significant aortic stenosis, unstable angina pectoris, or during or within one month of a myocardial infarction.
Danish: Cardiogenisk chok, klinisk signifikant aortisk stenose, ustabil angina pectoris eller ved eller en måned efter en myocardinal infarkt.
English: In single cases of in vitro fertilisation calcium antagonists like nifedipine have been associated with reversible biochemical changes in the spermatozoa's head section that may result in impaired sperm function.
Danish: I enkelte tilfælde af in-vitro fertilisering har calciumantagonister som nifedipin været associeret med reversible biokemiske forandringer i spermatozoens hoveddel, som kan have resulteret i uregelmæssigheder i spermfunktionen.
English: Nifedipine should be used with caution in patients with (threatening) ischemia of fingers and/or toes, because this can be worsened due to decreased tissue perfusion as a result of a lower perfusion pressure.
Danish: Nifedipin bør anvendes med forsigtighed hos patienter med (truende) iskæmi i fingre og/eller tæer, da denne tilstand kan forværres pga. den reducerede vævsperfusion, som resultat af et lavt perfusionstryk.
English: If you stop taking Nifedipine Pharmamatch retard If you suddenly stop using this medicine, the symptoms that you had before you started taking this medicine can come back.
Danish: Hvis De holder op med at tage Nifedipine Pharmamatch retard Hvis De pludselig holder op med at tage denne medicin, vil de symptomer De havde før De startede med at tage denne medicin vende tilbage.
English: You should not use Nifedipine Pharmamatch retard for secondary prevention of a heart attack.
Danish: De bør ikke anvende Nifedipine Pharmamatch retard til sekundær prævention af et hjerteanfald.
English: Therefore, Nifedipine Pharmamatch retard is effective in angina pectoris and hypertension.
Danish: Derfor er Nifedipine Pharmamatch retard effektivt ved angina pectoris og hypertension.
English: The possibility of an additive effect resulting in postural hypotension should be borne in mind when Nifedipine Pharmamatch retard is used in combination with other beta-blocking medicinal products and antihypertensive agents.
Danish: Man skal være opmærksom på muligheden for en additiv effekt, som resulterer i postural hypotension, når Nifedipine Pharmamatch retard bruges i kombination med andre beta-blokkere og antihypertensive stoffer.
English: Nifedipine Pharmamatch retard tablets must not be prescribed for these patients.
Danish: Nifedipine Pharmamatch retard tabletter må ikke foreskrives til disse patienter.
English: nocturnal enuresis, acute, reversible deterioration in renal function in patients with chronic renal insufficiency.
Danish: nocturn enuresis, akut, reversibel nedbrydning af nyrefunktionen hos patienter med kronisk nyreinsufficiens.
English: constipation, nausea.
Danish: Forstoppelse, kvalme.
English: When nifedipine is added to therapy with a diuretic, a temporary induced saluretic effect can occur, and a pre-existing hypokalaemia can be induced.
Danish: Når nifedipin tilføjes en behandling med diuretika kan der opstå en midlertidig induceret saluretisk effekt og en præeksisterende hypokalaemi kan blive induceret.
English: Blood pressure, ECG, central arterial pressure, pulmonary wedge pressure, urea and electrolytes should be monitored.
Danish: Blodtryk, EKG, centralt arterietryk, pulmonært indkilingstryk, urinstoffer og elektrolytter skal monitoreres.
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF NIFEDIPINE PHARMAMATCH RETARD 30/60 mg and associated names (See Annex I)
Danish: SAMLET RESUME AF DEN FAGLIGE VURDERING AF NIFEDIPINE PHARMAMATCH RETARD 30/60 mg og tilknyttede navne (se bilag I)
English: aplastic anaemia, increase in serum potassium when nifedipine is combined with propranolol.
Danish: aplastisk anæmi, stigning af kaliumserum, når nifedipin kombineres med propranolol.
English: In dialysis patients with malignant hypertension and hypovolaemia, a marked decrease in blood pressure can occur.
Danish: Hos dialysepatienter med malign hypertension og hypovolaemi, kan der forekomme et markant fald i blodtrykket.
English: Due to inhibition of the CYP3A4 system, cimetidine increases the plasma concentration of nifedipine, and therefore the antihypertensive effect of nifedipine may be potentiated.
Danish: På grund af hæmningen af CYP3A4-systemetet øger cimetidin plasmakoncentrationen af nifedipin, og derfor kan nifedipins anti-hypertensive effekt blive potentieret.
English: If necessary, the nifedipine dosage should be reduced (see also subsection ‘Effects of Nifedipine Pharmamatch retard on other active substances').
Danish: Og dosis af nifedipin bør om nødvendigt nedsættes (se også underafsnittet 'Effekter af Nifedipine Pharmamatch retard på andre stoffer').
English: Erythromycin, fluoxetine, protease-inhibitors and azole-derivatives No clinical interaction studies have been performed between nifedipine and active substances that inhibit the CYP3A4 system, like erythromycin, fluoxetine, protease-inhibitors (amprenavir, indinavir, nelfinavir, ritonavir, saquinavir) and azole-derivatives (ketoconazole, itraconazole and fluconazole).
Danish: Erythromycin, fluoxetin, protease-inhibitorer og azolderivater Der er ikke foretaget nogle kliniske interaktionsundersøgelser mellem nifedipin og aktive stoffer, der hæmmer CYP3A4-systemet, som erythromycin, fluoxetin, protease-inhibitorer (amprenavir, indinavir, nelfinavir, ritonavir, saquinavir) og azolderivater (ketoconazol, itraconazol og fluconazol).
English: - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
Danish: - Hvis nogle af bivirkningerne bliver alvorlige eller De bemærker nogen form for bivirkninger,
English: ventricular arrhythmias, conduction disturbances, exacerbation of supraventricular arrhythmias, digital blood flow reduction in patients with Raynaud's syndrome.
Danish: ventrikulær arrhythmi, ledningsforstyrrelse, exacerbation af supraventrikulær arrhythmi, reduktion af blodgennemstrømningen hos patienter med Raynaud's syndrom.
English: Co-administration of nifedipine with 100 mg acetylsalicylic acid does not alter the effect of acetylsalicylic acid on platelet aggregation or bleeding time.
Danish: Samtidig administration af nifedipin med 100 mg acetylsalicylsyre ændrer ikke effekten af acetylsalicylsyre på pladeaggregation eller blødningstid.
English: As a consequence, the blood pressure lowering effect of nifedipine may be increased.
Danish: Som følge heraf kan nifedipinens blodtrykssænkende effekt øges.
English: Thus, contraindicating the use of nifedipine in women of childbearing potential, which amounts to contraindicating it from the beginning of the first trimester of pregnancy, should result in a loss of chance in this target population since nifedipine cannot be considered as a teratogenic product.
Danish: Kontraindicering af nifedipine til kvinder i den fødedygtige alder, hvilket vil sige fra begyndelsen af første trimester af graviditeten, skulle derfor betyde færre tilfælde i denne målgruppe, da nifedipine ikke kan betragtes som et teratogent produkt.
English: Since symptoms of obstruction can occur in patients with pre-existing severe gastrointestinal narrowing, Nifedipine Pharmamatch retard should not be administered to those patients.
Danish: Da symptomer på obstruktion kan forekomme hos patienter med præeksisterende, alvorlige tarmforsnævringer, bør Nifedipine Pharmamatch retard ikke gives til disse patienter.
English: It is recommended to take the Nifedipine Pharmamatch tablets in the morning with a glass of water (not grapefruit juice).
Danish: Det anbefales, at tage Nifedipine Pharmamatch tabletterne om morgenen med et glas vand (ikke grapefrugtjuice).
English: In studies in mice, rats and rabbits, a dose which was maternally toxic induced teratogenic effects in some cases and embryotoxicity.
Danish: I undersøgelser med mus, rotter og kaniner, inducerede en dosis som var maternelt toksisk i nogle tilfælde teratogeniske effekter samt embryotoksicitet.
English: - Keep this leaflet.
Danish: - Gem denne indlægsseddel.
English: If necessary, your doctor can increase the dosage to 90 mg once-daily.
Danish: Deres læge kan om nødvendigt øge dosen til 90 mg en gang daglig.
English: As a precaution, the patient should be examined for symptoms of digoxin overdose and, if necessary, a reduction of the glycoside-dosage should be considered, taking into account the plasma concentration of digoxin.
Danish: Som en forholdsregel bør patienten undersøges for symptomer på digoxin-overdosis og glycosidedosis bør om nødvendigt nedsættes med hensyn til plasmakoncentrationen af digoxin.
English: In a clinical study, the effect of Nifedipine retard prolonged-release tablets on cardiovascular and cerebrovascular morbidity was studied.
Danish: I en klinisk undersøgelse blev effekten af Nifedipine retard depottabletter på kardiovaskulær og cerebrovaskulær sygelighed undersøgt.
English: Patients who are receiving kidney dialysis and have a very high blood pressure and low blood volume might experience a sudden drop in their blood pressure when they take Nifedipine Pharmamatch retard.
Danish: Patienter, der er i nyredialyse og har et meget højt blodtryk og en lav blodvolumen kan måske opleve et pludseligt fald af blodtrykket, når de tager Nifedipine Pharmamatch retard.
English: Co-administration of nifedipine with 100 mg acetylsalicylic acid, benazepril, candesartancilexetil, doxasozine, omeprazole, orlistat, pantoprazole, ranitidine, rosiglitazone or triamterene/hydrochlorothiazide does not affect the pharmacokinetics of nifedipine.
Danish: Samtidig administration af nifedipin med 100 mg acetylsalicylsyre, benazepril, candesartan cilexetil, doxazosin, omeprazol, orlistat, pantoprazol, ranitidin, rosiglitazon eller triamteren/hydrochlorothiazid påvirker ikke nifedipins farmakokinetiske effekt.
English: 6.6 Instructions for use and handling <and disposal> No special requirements.
Danish: 6.6 Særlige forholdsregler ved bortskaffelse Ingen særlige forholdsregler.
English: When used concomitantly, nifedipine does not affect the pharmacokinetics of candesartancilexetil, cerivastatin or irbesartan.
Danish: Ved samtidig brug påvirker nifedipin ikke farmakokinetikken af candesartan cilexetil, cerivastatin eller irbesartan.
English: - Nifedipine Pharmamatch retard is used to treat high blood pressure (hypertension).
Danish: - Nifedipine Pharmamatch retard anvendes til at behandle for højt blodtryk (hypertension).
English: - Nifedipine Pharmamatch retard is used to reduce the frequency of occurence of a tight, painful chest ache caused by a shortage of oxygen in the heart muscle (angina pectoris).
Danish: - Nifedipine Pharmamatch retard anvendes til at reducere hyppigheden af en spændt, smertefuld brystsmerte, der skyldes iltmangel i hjertemusklen (angina pectoris).
English: Medicines that do not influence Nifedipine Pharmamatch retard or are not influenced by Nifedipine Pharmamatch retard.
Danish: Lægemidler, der ikke påvirker Nifedipine Pharmamatch retard eller ikke er påvirket af Nifedipine Pharmamatch retard.
English: Co-administration of grapefruit juice reduces the first pass effect on nifedipine (see section 4.5).
Danish: Samtidig indtagelse af grapefrugtjuice reducerer first-pass-effekten på nifedipin (se afsnit 4.5).
English: Nifedipine is metabolised via the cytochrome P450 3A4 system (CYP3A4), which is present in the intestinal mucosa and the liver.
Danish: Nifedipin er metaboliseret via cytochrom P450 3A4-systemet (CYP3A4), som findes i tarmens slimhinde og i leveren.
English: Published data show that in individual cases the tacrolimus dose can be reduced when co-administered with nifedipine.
Danish: Publicerede data viser, at tacrolimus-dosis kan nedsættes i individuelle tilfælde ved samtidig administration af nifedipin.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON
Danish: OPLYSNINGER DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE EMBALLAGE
English: Tacrolimus has been shown to be metabolised via the cytochrome P450 3A4 system.
Danish: Tacrolimus har vist sig, at være metaboliseret via det cytochrome P450 3A4-system.