FrancophonIA/ELRC3.0 huggingface dataset:
English: ATC code: C08CA05
Danish: ATC-kode: C08CA05
English: This should be considered during treatment of hypertension.
Danish: Dette bør overvejes under behandlingen af hypertension.
English: - if you have diabetes.
Danish: - Hvis De har diabetes.
English: This leaflet was last approved in {MM/YYYY}.
Danish: Denne indlægsseddel blev sidst godkendt i {MM/ÅÅÅÅ}.
English: 6.3 Shelf life 3 years.
Danish: 6.3 Opbevaringstid 3 år.
English: As a result of this treatment, the serum calcium levels can reach or exceed the upper limit of normal levels.
Danish: Som et resultat af denne behandling kan serum calcium-niveauer nå eller overskride den øvre grænse for normale niveauer.
English: Do not stop the treatment early without consulting your doctor.
Danish: Stop ikke behandlingen uden først at have konsulteret Deres læge.
English: Increased or decreased heart rates are also a symptom of overdosage.
Danish: Øget eller nedsat hjertefrekvens er også et symptom på overdosering.
English: or as a continuous infusion of 5 mg/min.
Danish: eller som en konstant infusionsvæske på 5 mg/min.
English: The dosage of these medicines should be determined by the patient's response.
Danish: Dosen af disse lægemidler skal bestemmes ud fra patientens respons.
English: - in case of in vitro fertilisation (IVF).
Danish: - i tilfælde af in vitro fertilisering (IVF).
English: After regular intake of grapefruit juice, this effect may last for at least three days after the last ingestion of grapefruit juice.
Danish: Efter regelmæssig indtagelse af grapefrugt juice, kan denne effekt vare i mindst tre dage efter den sidste indtagelse af grapefrugtjuice.
English: Treatment should be titrated for optimal effect according to individual needs of the patient.
Danish: Behandlingen skal være titreret for at få en optimal effekt i henhold til patientens individuelle behov.
English: Furthermore, a deterioration of heart failure can occur.
Danish: Desuden kan der opstå en forværring af hjertestop.
English: Depending on the clinical symptoms, the standard dosage should be gradually increased.
Danish: Afhængigt af de kliniske symptomer, bør standarddosen øges gradvist.
English: This could mainly be attributed to the increased incidence of peripheral oedema.
Danish: Det kunne hovedsagligt skyldes øget tilfælde af perifert ødem.
English: fever in the first few days after initiating therapy.
Danish: feber i de første par dage efter påbegyndt behandling.
English: periorbital oedema, tinnitus.
Danish: periorbital ødem, tinnitus.
English: Intravenous magnesium sulphate
Danish: Intravenøst magnesiumsulfat
English: - if you use the medicine rifampicin (a medicine used in certain infection disease).
Danish: - Hvis De anvender lægemidlet rifampicin (et lægemiddel, der bruges til bestemte infektionssygdomme).
English: Pregnancy (See section 4.6).
Danish: Graviditet (Se afsnit 4.6).
English: Therefore, the ability to drive or use machines can be reduced.
Danish: Derfor kan evnen til at føre motorkøretøj eller betjene maskiner være nedsat.
English: The metabolites are pharmacologically inactive and non-toxic.
Danish: Metabolitterne er farmakologisk inaktive og ugiftige.
English: An almost constant release rate provides a relatively constant concentration of active substance in plasma, without major differences between maximal and minimal levels.
Danish: En næsten konstant frigivelsesfrekvens giver en relativt konstant koncentration af det aktive stof i plasma uden store forskelle mellem maksimum- og minimumniveauer.
English: The first two numbers denote the month, the last two numbers denote the year.
Danish: De første to (2) tal angiver måneden og de sidste to (2) tal angiver årstallet.
English: Dosage in case of reduced liver function If your liver function is lower than normal, your doctor can prescribe a lower dosage.
Danish: Dosering i tilfælde af nedsat leverfunktion Hvis Deres leverfunktion er lavere end normalt, kan Deres læge foreskrive en lavere dosis.
English: However, plasmaferesis can be recommended (high plasma protein-binding, relatively small volume of distribution).
Danish: Imidlertid kan vi anbefale plasmaferese (høj plasmaproteinbinding, relativ lille fordelingsvolumen).
English: - if the pumping force of the heart is insufficient (decompensatio cordis).
Danish: - Hvis hjertets pumpekraft er utilstrækkelig (decompensatio cordis).
English: Adverse reactions are often dose related and occur most frequently in the first couple of weeks after initiation of therapy.
Danish: Bivirkninger er ofte dosisrelaterede og forekommer hyppigst i de første par uger efter behandlingens start.
English: Antihypertensive medicines
Danish: Antihypertensive medikamenter
English: The incidence of heart failure shows a difference between both treatments (0.9% versus 0.3%).
Danish: Tilfældet af hjertestop viser en forskel mellem begge behandlinger (0,9% versus 0,3%).
English: Elimination of the active substance and the restoration of stable cardiovascular conditions have priority.
Danish: Udskillelse af det aktive stof og genetablering af stabile kardiovaskulære forhold har prioritet.
English: Nifedipine is not recommended for use in children and adolescents due to insufficient data on safety and efficacy.
Danish: Nifedipin er ikke anbefalet til brug hos børn og unge pga. utilstrækkelige data vedrørende sikkerhed og effekt.
English: If the effects are inadequate, the treatment can be continued, with ECG monitoring.
Danish: Hvis effekten er utilstrækkelig, skal behandlingen fortsættes med EKGmonitorering.
English: Read all of this leaflet carefully before you start taking using this medicine.
Danish: Læs hele denne indlægsseddel omhyggeligt, før De begynder at anvende dette lægemiddel.
English: In individual cases of concomitant use, neuromuscular block has been observed.
Danish: I individuelle tilfælde af samtidig brug er der observeret neuromuskulær blok.
English: For the treatment of all grades of hypertension.
Danish: Til behandling af alle grader af hypertension.
English: Additional fluids should be administered with caution to avoid cardiac overload.
Danish: Supplerende væske bør administreres med forsigtighed for at undgå hjerteoverload.
English: STATEMENT OF ACTIVE SUBSTANCE(S)
Danish: ANGIVELSE AF AKTIVT STOF(AKTIVE STOFFER)
English: - if you have a low blood pressure (hypotension).
Danish: - Hvis De har et lavt blodtryk (hypotension).
English: Eventually, unconsciousness can occur.
Danish: Der kan eventuelt opstå bevidstløshed.
English: However, HPLC measurements are unaffected.
Danish: Men HPLC-målingerne er upåvirkede.
English: - if you suffer from diarrhoea.
Danish: - Hvis De lider af diarre.
English: In severe cases, a lowering of the dose can be necessary.
Danish: I alvorlige tilfælde kan det være nødvendigt at nedsætte dosen.
English: - if your blood pressure is continuing to rise despite treatment (malignant hypertension).
Danish: - Hvis Deres blodtryk fortsætter med at stige på trods af behandlingen (malignant hypertension).
English: Therefore, the tablets are appropriate for once-daily administration.
Danish: Derfor er tabletterne egnet til administration en gang dagligt.
English: Special care is needed in case of very low blood pressure (severe hypotension with systolic pressure below 90 mmHg).
Danish: Der er behov for særlig forsigtighed i tilfælde af meget lavt blodtryk (alvorlig hypotension med systolisk tryk under 90 mmHg).
English: For hypertension:
Danish: Ved hypertension:
English: Hypotension as a result of cardiogenic shock and arterial vasodilatation should be treated with calcium (10-20 ml of calcium gluconate 10% slowly i.v., to be repeated if necessary).
Danish: Hypotension som et resultat af kardiogent chok og arteriel vasodilatation skal behandles med calcium (10-20 ml calciumgluconat 10% langsomt i.v., og gentages om nødvendigt).
English: Safety in malignant hypertension is not established.
Danish: Sikkerhed ved malign hypertension er ikke fastlagt.
English: - The Summary of Products Characteristic, labelling and package leaflet proposed by the applicant has been assessed based on the documentation submitted, the scientific discussion within the Committee and the new wording proposed in the updated Guideline on SPC dated October 2005 and the latest QRD templates version 7
Danish: - det af ansøgeren foreslåede produktresumé, etikettering og indlægsseddel er blevet vurderet på grundlag af den forelagte dokumentation, den faglige drøftelse i udvalget og den foreslåede ordlyd i den ajourførte udgave af Guideline on Summary of Product Characteristics fra oktober 2005 og de seneste QRD-modeller (version 7),
English: In case of life-threatening bradycardia, a temporary cardiac pacemaker can be used.
Danish: I tilfælde af livstruende bradycardia kan der bruges en midlertidig cardiacpacemaker.
English: For chronic stable angina pectoris (exertion-induced angina):
Danish: Ved kronisk stabil angina pectoris (aktivitets-induceret angina):
English: The use of rifampicin.
Danish: Brug af rifampicin.
English: In the event of overdose it is recommended to lay down the patient with elevated legs, for instance by using some pillows.
Danish: I tilfælde af en overdosis, anbefales det at man lægger patienten ned med løftede ben, for eksempel ved hjælp af nogle puder.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Oral use.
Danish: ANVENDELSESMÅDE OG INDGIVELSESVEJ(E) Oral brug.
English: In conclusion, the warning related to women of childbearing potential proposed by the applicant in section 4.6 Pregnancy and lactation is relevant and sufficient.
Danish: Det konkluderes, at ansøgerens foreslåede advarsel til kvinder i den fødedygtige alder under afsnit 4.6 ”Graviditet og amning” er relevant og tilstrækkelig.
English: Pregnancy and breast-feeding Ask your doctor or pharmacist for advice before taking any medicine.
Danish: Graviditet og amning Spørg Deres læge eller apotek om råd, før De tager nogen form for medicin.
English: In vitro fertilisation
Danish: In-vitro fertilisering
English: This randomised, double blind, prospective study was carried out on an average population of patients with hypertension that, besides a blood pressure of 150/95 mm Hg or higher or a systolic blood pressure of >160 mm Hg, presented with at least one other cardiovascular risk factor.
Danish: Denne randomiserede, dobbeltblinde, prospektive undersøgelse blev udført på en gennemsnitspopulation af patienter med hypertension, som udover et blodtryk på 150/95 mm Hg eller derover eller et systolisk blodtryk på >160 mm Hg, præsenteret med mindst en anden kardiovaskulær risikofaktor.
English: - The active substance is nifedipine.
Danish: - Det aktive stof er nifedipin.
English: Elimination of the product and the restoration of stable cardiovascular conditions may be needed.
Danish: Det kan være nødvendigt at udskille produktet og genetablere de stabile kardiovaskulære forhold.
English: - if you suffer from unstable angina pectoris.
Danish: - Hvis De lider af en ustabil angina pectoris.
English: Nifedipine is rapidly and almost completely absorbed (>90%).
Danish: Nifedipin optages hurtigt og næsten fuldstændigt (>90%).
English: A total of 6321 patients (55-80 years) were treated during 3 to 4.8 years with Nifedipine Retard or a standard combination of diuretics (hydrochlorothiazide 25 mg + amiloride 5 mg).
Danish: I alt blev 6321 patienter (55-80 år) behandlet over 3 til 4,8 år med Nifedipine Retard eller en standardkombination af diuretika (hydrochlorothiazid 25 mg + amilorid 5 mg).
English: After release and absorption of the final dose the plasma concentration decreases, showing the same half-life values that were observed with oral formulations.
Danish: Efter frigivelse og optagelse af den sidste dosis, reduceres plasmakoncentrationen og viser de samme halveringsværdier, som blev set ved orale formler.
English: Frequency of undesirable effects is classified as very common (>10%); common (1-10%); uncommon (0.1-1%); rare (0.01-0.1%) or very rare including isolated reports (<0.01%).
Danish: Hyppigheden af uønskede bivirkninger er klassificerede som meget almindelige (>10%); almindelige (1-10%); ualmindelige (0,1-1%) eller meget sjældne inkl.
English: However, the CHMP does not find it justified to contraindicate use in nursing mothers.
Danish: CHMP anser det dog ikke for begrundet at kontraindicere anvendelse af produktet til ammende mødre.
English: It should not be used for acute attacks of angina.
Danish: Bør ikke anvendes til akutte angina-anfald.
English: Medicines that are known to either inhibit or induce this enzyme can therefore alter the absorption (after oral administration) or elimination of nifedipine.
Danish: Lægemidler, der er kendt for enten at hæmme eller fremkalder dette enzym, kan derfor ændre absorptionen (efter oral-administration) eller udskillelse af nifedipin.
English: Nifedipine has a short half-life of approximately 2 - 4 hours.
Danish: Nifedipin har en kort halveringstid på ca. 2 - 4 timer.
English: In addition, β-sympathomimetics may be given, e.g. 0.2 mg isoprenalin slowly i.v.
Danish: Desuden kan der gives β-sympathomimeti, fx. 0,2 mg isoprenalin, langsomt i.v.
English: eye reactions such as eye pain, temporary vision disturbances.
Danish: Øjenreaktioner, så som smerter i øjne, midlertidige synsforstyrrelser.
English: Distribution Both nifedipine and its metabolites are mainly bound to plasma protein (92-98%).
Danish: Fordeling: Både nifedipin og dets metabolitter er hovedsagligt bundet til plasmaprotein (92-98%).
English: Severe hypotension due to vasodilatation, and tachycardia or bradycardia are the most likely manifestations of overdose.
Danish: Kliniske effekter alvorlig hypotension pga. vasodilatation og tachycardia eller bradycardia er de mest sandsynlige manifestationer på en overdosering.
English: To date, limited data on exposed first trimester pregnancies have not shown an increase in the frequency of congenital anomalies compared to the frequency in the general population.
Danish: Hidtil har de begrænsede data om eksponerede graviditeter i første trimester ikke vist nogen øget forekomst af medfødte misdannelser i forhold til befolkningen i almindelighed.
English: Dosage in case of reduced kidney function
Danish: Dosering i tilfælde af nedsat nyrefunktion
English: Moreover, the number of reported symptomatic adverse events was higher in the group treated with nifedipine than in the control group.
Danish: Desuden var antallet af rapporterede symptomatiske bivirkninger højere i den gruppe, der blev behandlet med nifedipin end i kontrolgruppen.
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Danish: Hvis De har fået oplyst af Deres læge, at De er intolerant over for nogle sukkerarter, skal De kontakte Deres læge før De tager dette lægemiddel.
English: Nifedipine is almost entirely metabolised (> 90%); approximately 70-80% is excreted in urine.
Danish: Nifedipin er næsten fuldstændigt metaboliseret (> 90%); ca. 70-80% er udskilt via urinen.
English: The tablets should be swallowed whole and should not be bitten, chewed or crushed.
Danish: Tabletterne bør sluges hele og skal ikke bides over, tygges eller knuses.
English: - if you have experienced a collapse which was caused by a heart problem (cardiogenic shock) - if you have a narrowed aorta (aortic stenosis).
Danish: - Hvis De har oplevet et kollaps pga. et hjerteproblem (kardiogent chok) - Hvis De har aorta-forsnævring (aortisk stenose).
English: Thus, the proposed wording in section 4.6. of the SmPC to avoid breastfeeding during treatment when necessary, is sufficient.
Danish: Den foreslåede ordlyd i afsnit 4.6. i produktresuméet om at undgå amning, når det skønnes nødvendigt, er derfor tilstrækkelig.
English: Therefore, a decrease or an increase in nifedipine plasma concentrations and hence an alteration in efficacy cannot be excluded.
Danish: Derfor kan en reduktion eller en forøgelse i nifedipinplasmakoncentrationerne, og en deraf ændret virkningsfuldhed ikke udelukkes.
English: Activated charcoal should be given in 4-hourly doses of 25g for adults, 10g for children if nifedipine has been digested accidentally.
Danish: Aktivt kul skal gives i doser a 25 g for voksne hver 4. time, 10 g for børn, hvis nifedipin er blevet fordøjet ved et uheld.
English: Your doctor will determine the duration of treatment.
Danish: Deres læge afgør behandlingens varighed.
English: Preclinical data revela no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and carcinogenic potential.
Danish: De prækliniske data viser ingen særlig fare for mennesker på basis af traditionelle undersøgelser af sikkerhedsfarmakologi, gentagen dosistoksicitet, genotoksicitet og karcinogenicitetspotentiale.
English: You should not use Nifedipine Pharmamatch retard to treat an angina attack when it occurs, but rather to reduce the frequency of the angina you experience over time.
Danish: De bør ikke anvende Nifedipine Pharmamatch retard til at behandle et angina-anfald, når det forekommer, men hellere til at reducere hyppigheden af den angina De oplever over tid.
English: If an insufficient increase in blood pressure is achieved with calcium and isoprenalin, vasoconstricting sympathomimetics such as dopamine or noradrenalin should be administered.
Danish: Hvis der opnås en utilstrækkelig forøgelse i blodtrykket med calcium og isoprenalin, bør der administreres karforsnævrende sympatomimetika så som dopamin eller noradrenalin.
English: BATCH NUMBER Batch:
Danish: FREMSTILLERENS BATCHNUMMER Batch:
English: Bradycardia can be treated symptomatically with atropine or with β-sympathomimetics, like isoprenalin.
Danish: Bradycardia kan behandles symptomatisk med atropin eller med β-sympatomimeti, ligesom isoprenalin.
English: Like all medicines, Nifedipine Pharmamatch retard can cause side effects, although not everybody gets them.
Danish: Som alle andre lægemidler kan Nifedipine Pharmamatch retard have bivirkninger, selvom ikke alle får dem.
English: In addition, in some cases, the use of nifedipine in order to treat pregnant hypertensive women is necessary.
Danish: I nogle tilfælde kan det desuden være nødvendigt at anvende nifedipine til behandling af hypertensive gravide kvinder.
English: The results show that Nifedipine Retard demonstrates both a comparable antihypertensive effect and a comparable effect on the above-mentioned composite end-point.
Danish: Resultaterne viser, at Nifedipine Retard demonstrerer både en sammenlignelig antihypertensiv effekt og en sammenlignelig effekt på ovennævnte sammensatte gennembrud.
English: Carton box with blister strips made of PVC/PVDC and aluminium foil.
Danish: Kartonæsker med blisterpakning af PVC/PVDC og aluminiumsfolie.
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION, APPLICANTS, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Danish: BILAG I FORTEGNELSE OVER LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORM, STYRKE, INDGIVELSESVEJ, ANSØGER, INDEHAVERE AF MARKEDSFØRINGSTILLADELSE I MEDLEMSSTATERNE
English: Nifedipine is contraindicated during pregnancy and not recommended in women who intend to get pregnant in the near future.
Danish: Nifedipin er kontraindikeret under graviditet og anbefales ikke til kvinder, der planlægger at blive gravide i den nærmeste fremtid.
English: The following posology is recommended for adults:
Danish: Til voksne anbefales følgende dosering:
English: If quinidine is added to an existing nifedipine therapy, blood pressure should be carefully monitored.
Danish: Hvis quinidin tilføjes en eksisterende nifedipin-behandling, bør blodtrykket monitoreres nøje.
English: It takes some time (lagtime of 2-4 hours) before the active substance escapes from Nifedipine Pharmamatch retard tablets.
Danish: Det tager noget tid (tidsforsinkelse på 2-4 timer) før det aktive stof udskilles fra Nifedipine Pharmamatch retard tabletterne.
English: By doing so, the blood flow in the heart and limbs is improved, lowering blood pressure and preventing chest pain (angina pectoris).
Danish: Ved at gøre det forbedres blodomløbet i hjertet og lemmer og blodtrykket falder og brystsmerter forebygges (angina pectoris).
English: In patients with possible hyperglycaemia, nifedipine should be given with caution.
Danish: Hos patienter med mulig hyperglycaemi, bør nifedipin gives med forsigtighed.
English: Symptoms of obstruction have also been seen in patients in which no gastrointestinal narrowing was diagnosed.
Danish: Symptomer på obstruktion er også observeret hos patienter, hvor der ikke blev diagnosticeret en tarmforsnævring.
English: MARKETING AUTHORISATION HOLDER Pharmamatch BV
Danish: INDEHAVER AF MARKEDSFØRINGSTILLADELSEN Pharmamatch BV
English: Nifedipine Pharmamatch retard may be used alone, or in combination with a medicine from another group of medicines called β-blockers.
Danish: Nifedipine Pharmamatch retard kan bruges alene eller i kombination med medicin fra en anden medicingruppe, der kaldes β-blokkere.
English: If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Danish: Hvis nogle af bivirkningerne bliver alvorlige eller De bemærker nogen form for bivirkninger, som ikke er nævnt i denne indlægsseddel, bør De fortælle det til Deres læge eller apotek.
English: Caution should be exercised in patients with hypotension, as there is a risk of further reduction in blood pressure.
Danish: Der skal udvises forsigtighed hos patienter med hypotension, da der er risiko for yderligere fald af blodtrykket.
English: paresthesia of the extremities (arms and legs), finger twitching.
Danish: paræstesi af ekstremiteter (arme og ben), trækninger i fingre.
English: It should not be used for secondary prevention of myocardial infarction.
Danish: Bør ikke anvendes til sekundær prævention af myocardial infarkt.
English: Round, biconvex tablets with a pale red colour.
Danish: Runde, bikonvekse tabletter med en blegrød farve.
English: - if you experience severe chest pains, or if the chest pains worsen.
Danish: - Hvis De oplever alvorlige brystsmerter eller hvis brystsmerterne forværres.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Danish: Patienter med sjældne heriditære problemer med galaktoseintolerans, Lapp laktasemangel eller glucose-galaktose malabsorption bør ikke tage dette lægemiddel.
English: Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, notably rifampicin, including medicines obtained without a prescription.
Danish: Oplys Deres læge eller apotek, hvis De tager eller for nyligt har taget andre lægemidler, især rifampicin, inkl.
English: Quinidine
Danish: Quinidin
English: In patients with hepatic impairment careful monitoring is required and, in severe cases, a lowering of the dose may be necessary.
Danish: Hos patienter med leversygdomme kræves der nøje overvågning, og i alvorlige tilfælde kan det være nødvendigt, at nedsætte dosis.
English: 6.4 Special precautions for storage Store in the original package.
Danish: 6.4 Særlige opbevaringsforhold Opbevares i den originale emballage.
English: Separate analysis of the individual end-points show little differences in incidence between the groups treated with nifedipine or diuretics of stroke (2.0% versus 2.3%), MI (2.9% versus 2.7%) and death caused by any other cardiovascular disease (0.4% versus 0.4%).
Danish: Separate analyser af de individuelle gennembrud viser små forskelle mellem grupper behandlet med nifedipin eller diuretika i tilfælde af slagtilfælde (2,0% versus 2,3%), MI (2,9% versus 2,7%) og død som følge af andre kardiovaskulære lidelser (0,4% versus 0,4%).
English: As a precaution, it is recommended to stop breast-feeding.
Danish: Som forholdsregel anbefales det at stoppe amningen.
English: Co-administration of nifedipine with rifampicin is therefore contra-indicated.
Danish: Samtidig administration af nifedipin med rifampicin er derfor kontraindiceret.