FrancophonIA/ELRC3.0 huggingface dataset:
English: For more information about treatment with Natpar, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Natpar, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: The medicine can only be obtained with a prescription and treatment should be supervised by a healthcare professional experienced in the management of patients with hypoparathyroidism.
Danish: Lægemidlet udleveres kun efter recept, og ordination og behandlingen bør overvåges af en sundhedsperson med erfaring i behandling af patienter med hypoparatyroidisme.
English: Natpar must not be used in patients who are having or have had radiation therapy to the bones, who have bone cancer or cancer that has spread to the bones and are at increased risk of developing a bone cancer called osteosarcoma.
Danish: Natpar må ikke anvendes hos patienter, der får eller har fået strålebehandling af knoglerne, eller som har knoglekræft eller kræft, der har bredt sig til knoglerne, og har øget risiko for at udvikle knoglekræft af typen osteosarkom.
English: Since Natpar has been granted a conditional approval, the company that markets Natpar will conduct a further study to confirm the benefits and risks of the medicine and the appropriateness of the once-aday dosing schedule.
Danish: Da Natpar har fået en betinget godkendelse, skal virksomheden, der markedsfører Natpar, udføre en supplerende undersøgelse for at bekræfte fordelene og risiciene ved lægemidlet og egnetheden af dets doseringsplan (én gang dagligt).
English: Natpar is used as an add-on to treatment with calcium and vitamin D supplements when these treatments have not worked well enough.
Danish: Natpar anvendes som tillægsbehandling sammen med tilskud af calcium og vitamin D, når disse ikke har haft tilstrækkelig virkning.
English: Natpar must also not be used in patients who have unexplained increases in the levels of an enzyme called bone alkaline phosphatase and those who have pseudohypoparathyroidism, a rare disease where the body does not respond adequately to the parathyroid hormone produced by the body.
Danish: Natpar må heller ikke anvendes hos patienter, som har uforklaret stigning i enzymet alkalisk fosfatase fra knoglerne, eller som har pseudohypoparatyroidisme, en sjælden sygdom, hvor kroppen ikke reagerer tilfredsstillende på det parathyroideahormon, der dannes af kroppen.
English: The active substance in Natpar, parathyroid hormone, is a copy of the natural hormone produced by the parathyroid glands.
Danish: Det aktive stof i Natpar, parathyroideahormon, er en kopi af det naturlige hormon, der dannes af biskjoldbruskkirtlerne.
English: Natpar is injected under the skin of the thigh using the Natpar pen.
Danish: Natpar sprøjtes ind under huden i låret ved hjælp af Natpar-pennen.
English: It replaces the missing hormone in patients with hypoparathyroidism, thus helping to restore calcium levels.
Danish: Det erstatter det manglende hormon hos patienter med hypoparatyroidisme og medvirker derved til at genoprette calciumindholdet.
English: In patients with this condition, the parathyroid glands in the neck do not produce enough parathyroid hormone which controls the level of calcium in the blood.
Danish: Hos patienter med denne sygdom danner biskjoldbruskkirtlerne i halsen ikke tilstrækkeligt med parathyroideahormon, som regulerer calciumindholdet i blodet.
English: Natpar contains the active substance parathyroid hormone.
Danish: Natpar indeholder det aktive stof parathyroideahormon.
English: Natpar has been shown to help control blood calcium levels in patients with hypoparathyroidism who are receiving calcium and vitamin D supplements.
Danish: Natpar er påvist at medvirke til regulering af calciumindholdet i blodet hos patienter med hypoparatyroidisme, som får tilskud af calcium og vitamin D.
English: How is Natpar used?
Danish: Hvordan anvendes Natpar?
English: For the full list of all side effects reported with Natpar, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Natpar fremgår af indlægssedlen.
English: For practical information about using Natpar, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Natpar, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: Natpar replaces the missing parathyroid hormone in patients with hypoparathyroidism.
Danish: Natpar erstatter det manglende parathyroideahormon hos patienter med hypoparatyroidisme.
English: How does Natpar work?
Danish: Hvordan virker Natpar?
English: What benefits of Natpar have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Natpar?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Natpar have also been included in the summary of product characteristics and the package leaflet.
Danish: Der er desuden anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge med henblik på sikker og effektiv anvendelse af Natpar.
English: Natpar is a hormone replacement medicine for treating adults with under-active parathyroid glands, a condition known as hypoparathyroidism.
Danish: Natpar er et hormon til erstatningsbehandling af voksne med underaktive biskjoldbruskkirtler (hypoparatyroidisme).
English: and calcium supplements, is then adjusted on the basis of the patient's blood calcium levels.
Danish: Dosis af Natpar såvel som patientens dosis af vitamin D- og calciumtilskud justeres derefter afhængigt af patientens indhold af calcium i blodet.
English: It is important that you take Iasibon at the right time and in the right way.
Danish: Det er vigtigt, at De tager Iasibon på det rigtige tidspunkt og på den rigtige måde.
English: The dose is determined by the doctor considering the following factors.
Danish: Dosis bestemmes af lægen efter overvejelse af følgende faktorer.
English: Elderly population (> 65 years)
Danish: Ældre population (> 65 år)
English: There are only very few data available on patients with African origin.
Danish: Der er kun få tilgængelige data vedrørende patienter af afrikansk oprindelse.
English: 90% Confidence Interval
Danish: 90 % konfidensinterval
English: 5 years.
Danish: 5 år
English: From a microbiological point of view, the product should be used immediately.
Danish: Ud fra et mikrobiologisk synspunkt skal præparatet anvendes med det samme.
English: You can help stop this happening by doing the following:
Danish: De kan mindske risikoen for at dette forekommer ved at gøre følgende:
English: After reconstitution: 24 hours.
Danish: Efter rekonstituering: 24 timer
English: How much to take
Danish: Hvor meget skal De tage
English: These symptoms usually disappear within a couple of hours or days.
Danish: Disse symptomer vil oftest forsvinde i løbet af et par timer eller dage.
English: Number of events (per patient)
Danish: Antal hændelser (pr. patient)
English: This is to check that you are being given the right amount of medicine.
Danish: Dette er for at undersøge, om De får den rigtige mængde medicin.
English: Do not let the tablet dissolve in your mouth
Danish: Lad ikke tabletten opløses i munden.
English: **See further information below †Identified in postmarketing experience.
Danish: ** Se yderligere information nedenfor † Identificeret efter markedsføring.
English: The analysis of the SMPR was time-adjusted and considered that one or more events occurring in a single 12 week period could be potentially related.
Danish: Analysen af SMPR var tidsjusteret og tog højde for, at en eller flere hændelser opstået i en enkelt 12ugers periode, kunne være potentielt relateret.
English: • Take your tablet with a full glass of water only (about 200 mL).
Danish: • Tag Deres tablet med et stort glas vand (ca. 200 ml).
English: Date of first authorisation: 21 January 2011 Date of latest renewal: 30 September 2015
Danish: Dato for første markedsføringstilladelse: 21. januar 2011 Dato for seneste fornyelse: 30 september 2015
English: DATE OF REVISION OF THE TEXT
Danish: 10 DATO FOR ÆNDRING AF TEKSTEN
English: 100 ml over 15 minutes
Danish: 100 ml over 15 minutter
English: In clinical trials, therapy has continued for up to 96 weeks.
Danish: I kliniske studier har behandlingen været fortsat i op til 96 uger.
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA PC:
Danish: UNIQUE IDENTIFIER - LÆSELIG DATA PC:
English: Not known (frequency cannot be estimated from the available data) • asthma attack
Danish: Ikke kendt (hyppigheden kan ikke vurderes ud fra tilgængelige data) astmaanfald
English: In a multivariate analysis, age was not found to be an independent factor of any of the pharmacokinetic parameters studied.
Danish: I en multivariatanalyse kunne alder ikke påvises som en uafhængig faktor for nogen af de undersøgte farmakokinetiske parametre.
English: The usual dose of Iasibon is one tablet each day.
Danish: Den sædvanlige dosis Iasibon er én tablet dagligt.
English: If you develop these symptoms, stop taking Iasibon and tell your doctor straight away (see sections 3 and 4).
Danish: Hvis du udvikler disse symptomer, skal du stoppe med at tage Iasibon og straks kontakte din læge (se punkt 3 og 4).
English: Mutagenicity/Carcinogenicity:
Danish: Mutagenicitet/karcinogenicitet:
English: Multiple events were therefore counted only once for the purposes of the analysis.
Danish: Multiple hændelser blev derfor kun talt én gang til analyseformålet.
English: How much to receive
Danish: Hvor meget skal der gives
English: This was a composite endpoint which had the following skeletal related events (SREs) as sub-components:
Danish: Dette var et sammensat slutpunkt, som havde følgende skeletrelaterede hændelser (SREs) inkluderet:
English: They are available in packs of 3, 6, 9, 28 and 84 tablets.
Danish: De fås i pakninger med 3, 6, 9, 28 og 84 tabletter.
English: The dose should be infused over at least 15 minutes.
Danish: Dosis skal infunderes over mindst 15 minutter.
English: UNIQUE IDENTIFIER - 2D BARCODE 2D barcode carrying the unique identifier included.
Danish: UNIQUE IDENTIFIER - 2D BARCODE 2D stregkode bærer den entydige identifikator inkluderet.
English: Film-coated tablets 3 film-coated tablets 6 film-coated tablets 9 film-coated tablets 28 film-coated tablets 84 film-coated tablets
Danish: Filmovertrukne tabletter 3 filmovertrukne tabletter 6 filmovertrukne tabletter 9 filmovertrukne tabletter 28 filmovertrukne tabletter 84 filmovertrukne tabletter
English: A limited number of patients (50 patients) have received a second infusion for hypercalcaemia.
Danish: Et begrænset antal patienter (50 patienter) har fået to infusioner mod hyperkalcæmi.
English: Drink a full glass of milk before you go. Do not make yourself sick.
Danish: Drik et helt glas mælk inden De kører.
English: If you are taking a tablet every other day or once a week, ask your doctor or pharmacist for advice.
Danish: Hvis De tager én tablet hver anden dag eller én gang om ugen, spørg da Deres læge eller apoteketspersonalet, til råds.
English: See section 4
Danish: Se punkt 4
English: * Note albumin-corrected serum calcium concentrations are calculated as follows:
Danish: * Bemærk at albuminkorrigerede serum-calciumkoncentrationer beregnes på følgende måde:
English: Your doctor will work out how much Iasibon you will be given depending on your illness.
Danish: Lægen vil bedømme, hvor meget Iasibon De skal have afhængigt af Deres sygdom.
English: Do not chew, suck or crush the tablet.
Danish: Lad være med at tygge, sutte eller knuse tabletten.
English: Taking this medicine
Danish: Når De tager denne medicin
English: Only clear solutions without particles should be used.
Danish: Kun klare opløsninger uden partikler må anvendes.
English: 500 ml over 1 hour
Danish: 500 ml over 1 time
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8 °C, unless reconstitution has taken place in controlled and validated aseptic conditions.
Danish: Hvis det ikke anvendes straks, er opbevaringstiden og betingelserne for opbevaring før anvendelsen brugerens ansvar, og opbevaringstiden må normalt ikke være længere end 24 timer ved 2-8 °C, medmindre rekonstitueringen har fundet sted under kontrollerede og validerede aseptiske betingelser.
English: No specific information is available on the treatment of overdosage with Iasibon.
Danish: Der er ingen tilgængelig specifik information vedrørende behandling af overdosering med Iasibon.
English: Iasibon with food and drink
Danish: Brug af Iasibon sammen med mad og drikke
English: Iasibon is indicated in adults for
Danish: Iasibon er indiceret til voksne til
English: However, the marketing authorisation holder shall submit periodic safety update reports for this medicinal product if the product is included in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Danish: Indehaveren af markedsføringstilladelsen skal fremsende periodiske, opdaterede sikkerhedsindberetninger (PSUR) for dette lægemiddel i overensstemmelse med kravene på listen over EU-referencedatoer (EURD list) som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF og offentliggjort på den europæiske webportal for lægemidler.
English: In most cases a raised serum calcium level can be reduced to the normal range within 7 days.
Danish: I de fleste tilfælde kan en forhøjet serum-calcium værdi reduceres til normal værdi i løbet af 7 dage.
English: Hypromellose (E464) Titanium dioxide E171
Danish: Hypromellose (E464) Titandioxid (E171)
English: The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch
Danish: På lægemidlets trykte indlægsseddel skal der anføres navn og adresse på den fremstiller, som er ansvarlig for frigivelsen af det pågældende batch.
English: Diluted solutions are for single use.
Danish: Fortyndede opløsninger er til engangsbrug.
English: Urinary CTx **
Danish: Urin CTx**
English: Infusion Volume 1 and Time 2
Danish: Infusionsvolumen1 og infusionstid2
English: The majority of the reports refer to cancer patients, but such cases have also been reported in patients treated for osteoporosis.
Danish: Hovedparten af rapporterne omhandler kræftpatienter, men lignende tilfælde er også rapporteret hos patienter i behandling for osteoporose.
English: Do not take Iasibon with food or any other drinks except plain water as Iasibon is less effective if it is taken with food or drink (see section 3).
Danish: Tag ikke Iasibon sammen med mad eller andre drikkevarer end vand, da Iasibon virker mindre effektivt, hvis det tages sammen med mad og drikke (se punkt 3).
English: Water may be taken at any time during the course of Iasibon treatment (see section 4.5).
Danish: Vand kan indtages på ethvert tidspunkt under Iasibon-behandlingen (se pkt.
English: This medicinal product does not require any special storage conditions prior to reconstitution.
Danish: Lægemidlet kræver ingen særlige opbevaringsbetingelser inden rekonstitution.
English: • injury or pain at the injection site
Danish: • skader eller smerte på injektionsstedet
English: Creatinine Clearance (ml/min)
Danish: Kreatininclearance (ml/min)
English: Iasibon therapy should only be initiated by physicians experienced in the treatment of cancer.
Danish: Behandling med Iasibon bør kun initieres af læger med erfaring med behandling af kræft.
English: • increased sensitivity of sound, taste or touch or changes in smell
Danish: • øget følsomhed for lyd, berøring eller smag eller ændringer i lugtesans
English: If anaphylactic or other severe hypersensitivity/allergic reactions occur, immediately discontinue the injection and initiate appropriate treatment.
Danish: Hvis der opstår en anafylaktisk reaktion eller andre svære overfølsomheds-/allergiske reaktioner, skal injektionen øjeblikkelig afbrydes og passende behandling initieres.
English: Total clearance of ibandronic acid is low with average values in the range 84-160 ml/min.
Danish: Den samlede ibandronsyreclearance er lav med gennemsnitsværdier i området 84-160 ml/min.
English: Medicinal products and supplements (including calcium) should similarly be avoided prior to taking Iasibon tablets.
Danish: Medicin og kosttilskud (herunder calcium) skal ligeledes undgås inden indtagelse af Iasibon-tabletter.
English: • Swallow the tablet whole.
Danish: • Synk tabletten hel.
English: • acetylsalicylic acid and non-steroidal anti-inflammatory medicines called “NSAIDs”, such as, ibuprofen or naproxen.
Danish: • acetylsalicylsyre , non-steroide anti-inflammatoriske stoffer kaldet NSAIDer, såsom, ibuprofen eller naproxen.
English: Medicinal product -Food Interactions
Danish: Lægemiddel-fødevareinteraktion
English: • if you are allergic to any other bisphosphonates
Danish: • hvis De er allergisk over for andre bisphosphonater
English: This helps to stop your bones from getting weaker.
Danish: Det modvirker at Deres knogler bliver svagere.
English: Lactose monohydrate Macrogol 4000
Danish: Lactosemonohydrat Macrogol 4000
English: Gamma-GT increased, creatinine increased
Danish: Forhøjet gamma-GT, forhøjet kreatinin
English: Milk or antacids should be given to bind Iasibon.
Danish: Der bør indtages mælk eller antacida med henblik på at binde Iasibon.
English: • a condition affecting the blood vessels in your brain called ‘cerebrovascular disorder' (stroke or brain bleeding)
Danish: • tilstand som påvirker blodkarrerne i din hjerne kaldet cerebrovaskulær forstyrrelse (slagtilfælde eller hjerneblødning)
English: The overall adverse event profile of ibandronic acid following the 15 minute infusion was consistent with the known safety profile over longer infusion times and no new safety concerns were identified relating to the use of a 15 minute infusion time.
Danish: Den samlede bivirkningsprofil for ibandronsyre efter 15 minutters infusion svarede til den sikkerhedsprofil, der er set ved længere infusionstider, og der blev ikke identificeret nogen nye sikkerhedsrisici ved anvendelsen af en 15 minutters infusionstid.
English: Due to the risk of oesophageal irritation, vomiting should not be induced and the patient should remain fully upright.
Danish: På grund af risikoen for øsofageal irritation, bør opkastning ikke induceres, og patienten bør forblive i oprejst stilling.
English: While on treatment, these patients should avoid invasive dental procedures if possible.
Danish: Hvis det er muligt, bør disse patienter under behandlingen undgå invasive dentale indgreb.
English: Quality of Life *
Danish: Livskvalitet*
English: Products containing calcium and other multivalent cations (such as aluminium, magnesium, iron), including milk and food, are likely to interfere with absorption of Iasibon tablets.
Danish: Produkter, som indeholder calcium og andre multivalente kationer (som f.eks. aluminium, magnesium, jern), herunder mælk og føde, vil sandsynligvis påvirke absorptionen af Iasibontabletter.
English: In general patients with osteolytic bone metastases require lower doses than patients with the humoral type of hypercalcaemia.
Danish: Generelt kræver patienter med osteolytiske knoglemetastaser lavere doser end patienter med humoral type hyperkalcæmi.
English: Iasibon tablets should be taken after an overnight fast (at least 6 hours) and before the first food or drink of the day.
Danish: Iasibon tabletter skal indtages efter faste om natten (mindst 6 timer) og før indtagelse af dagens første mad- og drikkevarer.
English: • Iasibon is normally given by a doctor or other medical staff who have experience with the treatment of cancer.
Danish: • De får som regel Iasibon af en læge eller sygeplejerske, som har erfaring med behandling af kræft.
English: ** Median change from baseline to last assessment
Danish: * Middelændring fra baseline til sidste evaluering
English: No systemic accumulation was observed when ibandronic acid was administered intravenously once every 4 weeks for 48 weeks to patients with metastatic bone disease.
Danish: Der fandtes ingen systemisk akkumulation, når ibandronsyre blev indgivet intravenøst én gang hver 4. uge i 48 uger til patienter med metastaserende knoglesygdom.
English: LIST OF EXCIPIENTS The tablets also contain lactose.
Danish: LISTE OVER HJÆLPESTOFFER Tabletterne indeholder også lactose .
English: Do not take this medicine if any of the above apply to you.
Danish: Tag ikke denne medicin, hvis noget af ovenstående passer på Dem.
English: Bisphosphonates act by inhibiting osteoclast activity, although the precise mechanism is still not clear.
Danish: Bisphosphonater virker ved at hæmme osteoklastaktiviteten, men virkningsmekanismen er endnu ikke fuldt ud klarlagt.
English: Bioavailability was reduced by approximately 75% when Iasibon tablets were administered 2 hours after a standard meal.
Danish: Biotilgængeligheden blev reduceret med ca. 75%, når Iasibontabletter blev indtaget 2 timer efter et standardmåltid.
English: - Treatment of tumour-induced hypercalcaemia with or without metastases
Danish: - behandling af tumorinduceret hyperkalcæmi med eller uden metastaser.
English: Your doctor may adjust your dose and duration of intravenous infusion if you have kidney problems.
Danish: Lægen kan vælge at justere Deres dosis og den tid, den intravenøse infusion tager, hvis De har nyreproblemer.
English: In most cases no specific treatment is required and the symptoms subside after a couple of hours/days.
Danish: I de fleste tilfælde kræves ingen specifik behandling, og symptomerne fortager sig efter et par timer/dage.
English: A shorter (i.e. 15 min) infusion time should only be used for patients with normal renal function or mild renal impairment.
Danish: En kortere infusionstid (dvs.15 minutter) bør kun overvejes for patienter med normal eller let nedsat nyrefunktion.
English: • After taking your tablet, wait at least 30 minutes.
Danish: • Efter indtagelse af tabletten skal De vente mindst 30 minutter.
English: Gender Bioavailability and pharmacokinetics of ibandronic acid are similar in both men and women.
Danish: Køn Biotilgængeligheden og farmakokinetikken for ibandronsyre er ens hos mænd og kvinder.
English: No difference was observed in the indicators of renal function.
Danish: Der blev ikke observeret nogen forskel i nyrefunktionens parametre.
English: You may be having a serious, potentially life threatening allergic reaction (see section 2).
Danish: Du kan have fået en alvorlig allergisk reaktion, som kan være livstruende (se punkt 2).
English: Consideration should be given to the severity of the hypercalcaemia as well as the tumour type.
Danish: Der skal tages hensyn til hvor alvorlig hyperkalcæmien er samt til tumortype.
English: Patients should pay particular attention and be able to comply with the dosing instructions (see section 4.2).
Danish: Patienter skal være særligt opmærksomme på og være i stand til at følge doseringsvejledningen (se pkt.
English: Method of administration For intravenous administration.
Danish: AdministrationTil intravenøs administration.
English: 1 0.9% sodium chloride solution or 5% glucose solution 2 Administration every 3 to 4 week
Danish: 1 0,9 % natriumchlorid- eller 5 % glucoseinfusionsvæske 2 Administration hver 3. til 4. uge
English: However, early plasma levels fall quickly, reaching 10% of peak values within 3 and 8 hours after intravenous or oral administration respectively.
Danish: De tidlige plasmaværdier falder dog hurtigt og når 10% af peakværdien indenfor 3 og 8 timer efter henholdsvis intravenøs og peroral administration.
English: No indication of carcinogenic potential was observed.
Danish: Der fandtes ingen tegn på karcinogenicitet.
English: • if you are having dental treatment or surgery or know that you need some in the future, tell your dentist that you are being treated with Iasibon for cancer
Danish: • hvis du får tandbehandling eller får foretaget en tandoperation, eller du ved, at du skal det i fremtiden, skal du fortælle din tandlæge, at du er i behandling med Iasibon på grund af din kræftsygdom