FrancophonIA/ELRC3.0 huggingface dataset:
English: If you forget to inject your medicine at the correct time, inject it as soon as you remember unless it is almost time for the next dose.
Danish: Hvis du glemmer at sprøjte dig på det rigtige tidspunkt, må du gøre det så snart du husker det, medmindre det næsten er tid til næste dosis.
English: Bioavailability following subcutaneous and intramuscular injection in humans is high and similar for the two routes of administration (71% and 66%, respectively).
Danish: Biotilgængeligheden efter subkutan og intramuskulær injektion hos mennesker er høj og ens for de to administrationsveje (henholdsvis 71% og 66%).
English: General characteristics of the active substance
Danish: Generelle karakteristika ved det aktive stof
English: The holder of this marketing authorisation must inform the European Commission about the marketing plans for the medicinal product authorised by this decision.
Danish: • ANDRE BETINGELSER Indehaveren af markedsføringstilladelsen skal oplyse Europa-Kommissionen om markedsføringsplanen for det lægemiddel, der er godkendt i henhold til denne beslutning.
English: Your doctor may then decide that it is not safe for you to receive this medicine.
Danish: Din læge kan så afgøre, hvorvidt det er sikkert eller ej for dig at tage denne medicin.
English: Your body's response to treatment will be tested at regular intervals and your doctor will decide whether your treatment needs to be continued and which dose should be used.
Danish: Din krops reaktion på behandlingen vil med jævne mellemrum blive testet, og din læge vil så bestemme hvorvidt behandlingen bør forlænges og hvilken dosis, der bør anvendes.
English: • anaphylactic shock (a very severe type of allergic response)
Danish: • anafylaktisk chok (en meget alvorlig form for allergisk reaktion)
English: Again, this effect disappears with time, usually during the first or second week of treatment.
Danish: Men det går også væk med tiden, normalt i løbet af den første eller anden uge af behandlingen.
English: Do not use after the expiry date stated on the ampoule and the packaging.
Danish: Må ikke anvendes efter udløbsdatoen angivet på ampullen og pakningen.
English: Any unused product must be discarded.
Danish: Ubrugt produkt skal kasseres.
English: Never change the dose yourself or stop injecting the medicine without consulting your doctor first.
Danish: Du må aldrig selv regulere din dosis eller holde op med at tage din medicin uden først at have konsulteret din læge.
English: If you are pregnant, please tell your doctor.
Danish: Hvis du er gravid, skal du underrette din læge herom.
English: Dosage is to be adjusted to the individual patient's needs.
Danish: Dosis bør justeres I overensstemmelse med den enkelte patients behov.
English: The duration of treatment depends on the indication for treatment and the patient´s response.
Danish: Varigheden af behandlingen afhænger af indikationen og patientens respons.
English: The presence of antibodies appears to bear no relationship to allergic reactions, which are rare.
Danish: Tilstedeværelsen af antistoffer synes ikke at være forbundet med allergiske reaktioner, som er sjældne.
English: This is considered a species-specific effect and of no clinical relevance.
Danish: Dette anses for værende artsspecifikt og uden klinisk relevans.
English: This effect is diminished as osteoclastic activity is reduced.
Danish: Denne effekt falder i takt med, at osteoklast-aktiviteten reduceres.
English: It is recommended to store the ampoule in the lower part or the door of the refrigerator to protect the solution from freezing.
Danish: Det anbefales at opbevare ampullen nederst i køleskabet eller i køleskabsdøren for at beskytte opløsningen mod evt. frysning.
English: The dose may be reduced after the condition of the patient has improved.
Danish: Dosis kan reduceres, efter at patientens tilstand er forbedret.
English: In this case, you should wait until it is time to inject the next dose and then continue as before.
Danish: I så tilfælde skal du vente indtil det er tid til den næste dosis og så fortsætte på almindelig vis.
English: Peak plasma concentrations are attained within the first hour of administration.
Danish: Maksimale plasmakoncentrationer nås inden for den 1. time efter administration.
English: Such allergic reactions have only been seen in a very few cases and the most extreme form, anaphylactic shock, is very rare.
Danish: Sådanne allergiske reaktioner er kun set i meget få tilfælde og den mest ekstreme form, anafylaktisk chok er meget sjælden.
English: You should discuss the possible undesirable effects with your doctor who will be able to advise you on the risks and benefits of your treatment.
Danish: Det er vigtigt, at du drøfter eventuelle uønskede bivirkninger med din læge, som kan informere dig om behandlingens risici og gavnlige virkning.
English: The metabolites lack the specific biological activity of calcitonin.
Danish: Metabolitterne besidder ikke calcitonins specifikke biologiske aktivitet.
English: An antiemetic may be administered, if required.
Danish: Der kan administreres anti-emetika ved behov.
English: The pharmacological properties of the synthetic and recombinant peptides have been demonstrated to be qualitatively and quantitatively equivalent.
Danish: De syntetiske og rekombinate peptiders farmakologiske egenskaber er vist at være kvalitativt og kvantitativt ækvivalente.
English: Higher blood levels may be associated with increased incidence of nausea and vomiting.
Danish: Højere blodniveauer kan være forbundet med øget forekomst af kvalme og opkastning.
English: The following instructions for use are recommended to ensure that you obtain the full benefit of treatment with FORCALTONIN.
Danish: De følgende instruktioner er udarbejdet med henblik på at sikre, at du får det bedst mulige udbytte af behandlingen med FORCALTONIN.
English: Inform your doctor immediately if any of the above effects occur.
Danish: Informér straks din læge, hvis nogen af de ovennævnte bivirkninger finder sted.
English: • difficulties in breathing (bronchospasm)
Danish: • åndedrætsbesvær (bronkospasme)
English: Calcitonin is also contraindicated in patients with hypocalcaemia.
Danish: Calcitonin er også kontraindiceret til patienter med hypocalcæmi.
English: Conventional long-term toxicity, reproduction, mutagenicity, and carcinogenicity studies have been performed in laboratory animals.
Danish: Der er udført konventionelle langtidsstudier vedrørende toksicitet, reproduktion, mutagenicitet og carcinogenicitet på forsøgsdyr.
English: Very common: Nausea with or without vomiting is noted in approximately 10% of patients treated with calcitonin.
Danish: Meget almindelig: Kvalme, med eller uden opkastning, ses hos ca. 10% af patienterne behandlet med calcitonin.
English: • metallic taste in the mouth
Danish: • metalsmag i munden
English: Forcaltonin should be used immediately after the single-use ampoule is opened.
Danish: Forcaltonin bør straks bruges efter at engangsampullen er åbnet.
English: Serious allergic reactions will need emergency treatment.
Danish: Alvorlige allergiske reaktioner kræver akut behandling.
English: • swelling of the tongue or throat
Danish: • hævelse af tunge eller hals
English: There have been no reports that other drugs influence the effects of FORCALTONIN.
Danish: Det er ikke rapporteret, at andre lægemidler har indflydelse på FORCALTONINs indvirkninger.
English: You should also talk to your doctor if you feel that the effect of FORCALTONIN is decreasing or that you are no longer benefiting from treatment.
Danish: Du bør også drøfte det med din læge, hvis du mener, at virkningen af FORCALTONIN er aftagende eller behandlingen måske ikke længere hjælper.
English: Flushing of the face and hands has been noted.
Danish: Rødme i ansigtet og på hænder ses også.
English: If you use more FORCALTONIN than you should:
Danish: Hvis du får taget mere FORCALTONIN end du skulle:
English: Tell your doctor as soon as possible if you miss a dose of FORCALTONIN.
Danish: Du skal underrette din læge så hurtigt som muligt, hvis du glemmer en dosis FORCALTONIN.
English: Any product where such defects are observed should be discarded.
Danish: Produkter med sådanne defekter skal kasseres.
English: Use in elderly, hepatic and renal impairment patients Experience with the use of calcitonin in the elderly has shown no evidence of reduced tolerability or altered dosage requirements.
Danish: Anvendelse til ældre patienter samt patienter med lever- eller nyreinsuffiens Erfaring med anvendelse af calcitonin til ældre har ikke vist tegn på reduceret tolerabilitet eller ændret dosisbehov.
English: Examples of serious allergic reactions to salmon calcitonin are:
Danish: Eksempler på alvorlige allergiske reaktioner på laksecalcitonin er:
English: Never take a double dose to make up for a missed dose.
Danish: Man må aldrig tage en dobbeltdosis.
English: If you notice any unwanted effects not mentioned in this leaflet or any change in your health while receiving this medicine, or afterwards, please inform your doctor, nurse or pharmacist (chemist).
Danish: Hvis du har bivirkninger, der ikke er omtalt i denne pjece eller oplever en forandring i dit helbred imens du tager denne medicin, eller bagefter, må du underrette din læge, sygeplejerske eller apoteker herom.
English: However, the clinical relevance of this finding is not known.
Danish: Den kliniske relevans af dette fund er dog ukendt.
English: Approximately 10% of patients treated with salmon calcitonin suffer from nausea, sometimes with vomiting.
Danish: Ca. 10% af patienter i behandling med laksecalcitonin lider af kvalme og nogle gange opkastning.
English: The salmon calcitonin contained in Forcaltonin is not made by a conventional, chemical method but by genetic engineering.
Danish: Laksecalcitoninen i FORCALTONIN er ikke fremstillet ved en almindelig kemisk metode men ved genteknologi.
English: Dosages of these drugs may require adjustment in view of the fact that their effects may be modified by changes in cellular electrolyte concentrations.
Danish: Det kan være nødvendigt at justere dosis af disse lægemidler, da deres virkning kan påvirkes af ændringer i cellulære elektrolytkoncentrationer.
English: The only serious undesirable effect which has been reported in patients treated with salmon calcitonin is an allergic reaction.
Danish: De eneste alvorlige bivirkninger, der er rapporteret hos patienter behandlet med laksecalcitonin, er en allergisk reaktion.
English: Should the solution become frozen, the ampoule must be discarded.
Danish: Hvis opløsningen fryser, skal ampullen kasseres.
English: Calcitonin has short absorption and elimination half-lives of 10-15 minutes and 50-80 minutes, respectively.
Danish: Calcitonin har kort absorptions- og halveringstid på henholdsvis 10-15 og 50-80 minutter.
English: FORCALTONIN should therefore not be given to pregnant women.
Danish: FORCALTONIN må derfor ikke gives gravide kvinder.
English: If you have the impression that the effect of FORCALTONIN is too strong or too weak, talk to your doctor or pharmacist.
Danish: Hvis du mener at indvirkningen af FORCALTONIN er enten for stærk eller for svag, skal du drøfte det med din læge eller apoteker.
English: Pharmacotherapeutic group: antiparathyroid hormone, ATC code: H05BA01 (calcitonin, salmon).
Danish: Farmakoterapeutisk gruppe: anti-parathyroidhormon, ATC-kode: H05BA01 (calcitonin, laks).
English: If you or your doctor accidentally inject more than the recommended dose of FORCALTONIN, it is extremely unlikely to have any serious effects.
Danish: Hvis du eller din læge ved et hændeligt uheld kommer til at give dig mere end den anbefalede FORCALTONIN-dosis, er det næsten udelukket, at der vil opstå alvorlige bivirkninger.
English: The remaining effects can be treated by your doctor if they persist.
Danish: De andre tilfælde af bivirkninger kan behandles af din læge, hvis de er vedvarende.
English: Using FORCALTONIN with other medicines:
Danish: FORCALTONIN sammen med anden medicin:
English: • Prevention of acute bone loss due to sudden immobilisation such as in patients with recent osteoporotic fractures
Danish: • Forebyggelse af akut knogletab på grund af pludselig immobilisering som hos patienter med nylige osteoporotiske frakturer
English: Store in a refrigerator (2°C - 8°C) .
Danish: Opbevares i køleskab (2°C - 8°C).
English: Prevention of acute bone loss:
Danish: Forebyggelse af akut knogletab:
English: In pharmacological studies, calcitonin has been shown to have analgesic activity in animal models.
Danish: I farmakologiske studier har calcitonin vist at have analgetisk aktivitet i dyremodeller.
English: Salmon calcitonin is devoid of embryotoxic, teratogenic and mutagenic potential.
Danish: Laksecalcitonin har intet embryotoksisk, teratogent eller mutagent potentiale.
English: In addition, salmon calcitonin could be administered by intravenous injection after previous rehydration.
Danish: Desuden kan lakse calcitonin administreres ved intravenøs injektion efter forudgående rehydrering.
English: Calcitonin has not been studied in pregnant women.
Danish: Calcitonin er ikke undersøgt hos gravide kvinder.
English: Rare: In case of patients with high bone remodelling (Paget's disease and young patients) a transient decrease of calcaemia may occur between the 4th and the 6th hour after administration, usually asymptomatic
Danish: Sjælden: Hos patienter med høj knogleomsætning (Paget's sygdom og unge patienter) kan der opstå forbigående fald i calcæmien 4-6 timer efter administration; dette er sædvanligvis asymptomatisk.
English: He can perform a skin test to find out how sensitive you are to salmon calcitonin.
Danish: Han kan foretage en priktest for at finde ud af, hvor følsom du er overfor laksecalcitonin.
English: Hypersensitivity to the active substance or to any of the excipients.
Danish: Hypersensitivitet over for den aktive substans eller over for et eller flere hjælpestoffer.
English: For subcutaneous, intramuscular or intravenous infusion (product specific) use in individuals aged 18 years or more.
Danish: Til subkutan, intramuskulær eller intravenøs (præparat specifikt) indgivelse hos personer, der er fyldt 18 år eller ældre.
English: PHARMACEUTICAL FORM AND CONTENTS Solution for injection - Pack of 10 doses:
Danish: LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE) Opløsningsvæske til injektion - Pakning med 10 doser:
English: No data exist on the effects of injectable calcitonin on the ability to drive and use machines.
Danish: Der eksisterer ingen data om effekterne af calcitonin til injektion på evnen til at køre og anvende maskineri.
English: If you have further questions, please ask your doctor or your pharmacist.
Danish: Hvis De har yderligere spørgsmål, bedes De kontakte Deres læge eller apotek.
English: • diuresis (increase in urination)
Danish: • diurese (øget vandladning)
English: Rare: Neutralising antibodies to calcitonin rarely develop.
Danish: Sjælden: Der udvikles sjældent neutraliserende antistoffer over for calcitonin.
English: Calcitonin receptor down-regulation may also result in a reduced clinical response in a small percentage of patients following long-term therapy.
Danish: Calcitoninreceptor nedjustering kan også medføre nedsat klinisk respons hos en lille procentdel af patienterne efter langtids-behandling.
English: If you forget to take FORCALTONIN:
Danish: Hvis du glemmer at tage FORCALTONIN:
English: The development of these antibodies is not usually related to loss of clinical efficacy, although their presence in a small percentage of patients following long-term therapy with calcitonin may result in a reduced response to the product.
Danish: Udviklingen af disse antistoffer er sædvanligvis ikke forbundet med tab af klinisk effekt, selvom deres tilstedeværelse efter langtids-behandling med calcitonin hos en lille procentdel af patienterne kan medføre nedsat respons over for præparatet.
English: Salmon calcitonin does not cross the placental barrier.
Danish: Laksecalcitonin passerer ikke placentabarrieren.
English: The length of time over which you will receive FORCALTONIN will depend on the way you respond to the treatment.
Danish: Hvor lang tid du vil blive behandlet med FORCALTONIN afhænger af hvordan du reagerer på behandlingen.
English: Calcitonin is secreted into the milk.
Danish: Calcitonin udskilles i mælken.
English: Such reactions should be differentiated from generalised or local flushing, which are common non-allergic effects of calcitonin (see 4.8).
Danish: Sådanne reaktioner bør adskilles fra generaliseret eller lokal rødmen, hvilket er almindelige, ikke-allergiske reaktioner ved calcitonin (se pkt.
English: Forcaltonin is contained in Type I, glass ampoules, designed to accommodate up to 1 ml of solution.
Danish: Forcaltonin er indeholdt i glasampuller af type I, form B, der er beregnet til at rumme op til 1 ml opløsning.
English: You should tell your doctor if you are taking other calcium lowering drugs, such as bisphosphonates, as the combination of these drugs with FORCALTONIN might cause the amount of calcium in your blood to become too low.
Danish: Du skal underrette din læge, hvis du tager andre former for kalciumnedsættende lægemidler, såsom bifosfonater, da en kombination af disse lægemidler med FORCALTONIN kan medføre at kalciumindholdet i dit blod bliver for lavt.
English: In lactating animals given calcitonin, suppression of milk production has been observed.
Danish: Der er hos diegivende dyr, der fik calcitonin, observeret suppression af mælkeproduktionen.
English: Because calcitonin is a peptide, the possibility of systemic allergic reactions exists and allergic-type reactions including isolated cases of anaphylactic shock have been reported in patients receiving calcitonin.
Danish: Da calcitonin er et peptid, er der risiko for systemiske allergiske reaktioner, og der er indberettet allergi-lignende reaktioner, inklusive isolerede tilfælde af anafylaktisk shock, hos patienter der har fået calcitonin.
English: What FORCALTONIN is and what it is used for Before you use FORCALTONIN How to use FORCALTONIN Possible side effects
Danish: Hvad FORCALTONIN er, og hvad det anvendes til Hvad De skal gøre, før De begynder at tage FORCALTONIN Hvordan De anvender FORCALTONIN Hvilke mulige bivirkninger FORCALTONIN har Hvordan De opbevarer FORCALTONIN
English: Therefore, breast-feeding is not recommended during treatment.
Danish: Det frarådes derfor at amme under behandlingen.
English: There is a relationship between the subcutaneous dose of calcitonin and peak plasma concentrations.
Danish: Der er en sammenhæng mellem den subkutane dosis af calcitonin og maksimale plasmakoncentrationer.
English: Nausea, vomiting, flushing and dizziness are known to be dose dependent when calcitonin is administered parenterally.
Danish: Kvalme, opkastning, rødmen og svimmelhed vides at være dosisafhængige når calcitonin administreres parenteralt.
English: Gastrointestinal disorder:
Danish: Gastrointestinale sygdomme:
English: If the response to treatment is not satisfactory after one or two days, the dose may be increased to 400 International Units every 6 to 8 hours.
Danish: Hvis reaktionen på behandlingen ikke er tilfredsstillende efter én eller to dage, kan dosen sættes op til 400 internationale enheder hver 6.-8. time.
English: Tell your doctor or nurse immediately, if you notice any of the effects listed below.
Danish: Underret med det samme din læge eller sygeplejerske, hvis du bemærker nogen af nedenstående bivirkninger.
English: The use of calcitonin in combination with bisphosphonates may result in an additive calcium-lowering effect.
Danish: Brug af calcitonin i kombination med bisfosfonater kan resultere i en additiv calcium-sænkende effekt.
English: • Paget's disease
Danish: • Paget's sygdom
English: Calcitonin should be used during pregnancy only if treatment is considered absolutely essential by the physician.
Danish: Calcitonin bør kun anvendes under graviditet, hvis lægen skønner det absolut nødvendigt.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. it is essentially sodium free.
Danish: Dette lægemiddel indeholder mindre end 1 mmol natrium (23 mg) pr. dosis, dvs., at det stort set er natriumfrit.
English: Skin testing should be conducted in patients with suspected sensitivity to calcitonin prior to their treatment with calcitonin.
Danish: Der bør udføres hudtest af patienter, hvor der er mistanke om overfølsomhed over for calcitonin, inden behandling påbegyndes.
English: However, the clinical relevance of this finding is not known (see section 5.2)
Danish: Den kliniske relevans af dette fund kendes dog ikke (se pkt.
English: Salmon calcitonin is primarily and almost exclusively degraded in the kidneys, forming pharmacologically inactive fragments of the molecule.
Danish: Lakse calcitonin nedbrydes primært og næsten udelukkende i nyrerne, hvor der dannes farmakologisk inaktive fragmenter af molekylet.
English: If you are unsure whether you are allergic to salmon calcitonin, please discuss the matter with your doctor.
Danish: Hvis du er usikker på, om du er overfølsom overfor laksecalcitonin, bør dette drøftes med din læge.
English: Immune system disorders:
Danish: Forstyrrelser i immunsystemet:
English: Serum calcium levels may be transiently decreased to below normal levels following administration of calcitonin, notably upon initiation of therapy in patients with abnormally high rates of bone turnover.
Danish: Serumcalcium-niveauet kan forbigående falde til under normalgrænsen efter administration af calcitonin, specielt efter påbegyndt behandling hos patienter med abnormt høj knogleomsætning.
English: Extreme sensitivity to salmon calcitonin may cause difficulties in breathing (bronchospasm), swelling of the tongue or throat, or even an anaphylactic shock (a very severe type of allergic response).
Danish: Ekstrem overfølsomhed over for laksecalcitonin kan medføre åndedrætsbesvær (bronkospasme), hævelse af tunge eller hals, eller endda anafylaktisk chok (en meget alvorlig type allergisk reaktion).
English: By inhibiting osteoclast activity via its specific receptors, salmon calcitonin decreases bone resorption.
Danish: Ved at hæmme osteoklastaktiviteten via dets specifikke receptorer, nedsætter laksecalcitonin knogleresorptionen.
English: Some of the undesirable effects will disappear without being treated but others may need medical attention.
Danish: Nogle af de uønskede bivirkninger går væk af sig selvuden behandling - mens andre muligvis skal behandles.
English: Animal studies have shown that calcitonin is primarily metabolised via proteolysis in the kidney following parenteral administration.
Danish: Dyreundersøgelser har vist, at calcitonin efter parenteral administration primært metaboliseres via proteolyse i nyrerne.
English: The manufacturer is FAMAR S.A., 7 P. Marinopoulou Str., 174 56 Alimos, Athens, Greece.
Danish: Producenten er FAMAR S.A., 7 P. Marinopoulou Str., 174 56 Alimos, Athens, Grækenland.
English: Nervous system disorders: Uncommon: metallic taste in the mouth; dizziness
Danish: Sygdomme i nervesystemet: Usædvanlig: metallisk smag i munden; svimmelhed
English: Patients must therefore be warned that transient dizziness may occur, in which case they should not drive or use machines.
Danish: Patienter skal derfor advares om, at midlertidig svimmelhed kan forekomme, i hvilket tilfælde de ikke bør køre eller anvende maskineri.
English: METHOD AND ROUTE(S) OF ADMINISTRATION For subcutaneous (SC), intramuscular (IM) or intravenous (IV) injection.
Danish: ANVENDELSESMÅDE OG INDGIVELSESVEJ(E) Til: subkutan (SI), intramuskulær (IM) eller intravenøs (IV) injektion.
English: Paget's disease:
Danish: Paget's sygdom:
English: It is not known if the substance is excreted in human milk.
Danish: Det vides ikke, om stoffet udskilles i modermælk.
English: If the response is not satisfactory after one or two days, the dose may be increased to a maximum of 400 IU every 6 to 8 hours.
Danish: Hvis respons ikke er tilfredsstillende efter 1 eller 2 dage, kan dosis øges til maksimalt 400 IU hver 6.8. time.
English: Injectable calcitonin may cause transient dizziness which may impair the reaction of the patient.
Danish: Calcitonin til injektion kan forårsage midlertidig svimmelhed, hvilket kan påvirke patientens reaktionsevne.