natgillin/translations-raw huggingface dataset:
Calcitoninreceptor nedjustering kan også medføre nedsat klinisk respons hos en lille procentdel af patienterne efter langtids- behandling.
Calcitonin receptor down-regulation may also result in a reduced clinical response in a small percentage of patients following long-term therapy.
Meget sjælden: alvorlige allergi- lignende bivirkninger, såsom bronkospasme, hævelse af tunge og hals samt i isolerede tilfælde, anafylaksis.
Very rare: serious allergic-type reactions, such as bronchospasm, swelling of the tongue and throat, and in isolated cases, anaphylaxis.
Der er injiceret enkeltdoser (op til 10. 000 IE) laksecalcitonin uden bivirkninger ud over kvalme og opkastning og exacerbation af farmakologiske virkninger.
Single doses (up to 10,000 I. U.) of injectable salmon calcitonin have been administered without adverse reactions, other than nausea and vomiting, and exacerbation of pharmacological effects.
5.
5/ 30 5.
Farmakoterapeutisk gruppe: anti- parathyroidhormon, ATC- kode:
Pharmacotherapeutic group: antiparathyroid hormone, ATC code:
H05BA01 (calcitonin, laks).
H05BA01 (calcitonin, salmon).
5/ 31 Calcitonin er et calciotropisk hormon, som hæmmer knogleresorptionen ved direkte virkning på osteoklasterne.
Calcitonin is a calciotropic hormone, which inhibits bone resorption by a direct action on osteoclasts.
Calcitonin reducerer markant knogleomsætningen i tilstande med øget knogleresorptionshastighed, såsom Paget’ s sygdom og akut knogletab på grund af pludselig immobilisering.
Calcitonin markedly reduces bone turnover in conditions with an increased rate of bone resorption such as Paget ‘ s disease and acute bone loss due to sudden immobilisation.
Der ses efter behandling med calcitonin fald i knogleresorptionen, vurderet ved en reduktion i urinudskillelsen af hydroxyprolin og deoxypyridinolin, hos både raske frivillige og patienter med knoglerelaterede forstyrrelser, inklusiv Paget’ s sygdom og osteoporose.
Decreases in bone resorption as judged by a reduction in urinary hydroxyproline and deoxypyridinoline are observed following calcitonin treatment in both normal volunteers and patients with bone-related disorders, including Paget’ s disease and osteoporosis.
Calcitonins calcium- sænkende effekt forårsages både af et fald i calciumeffusion fra knoglerne til den ekstracellulære væske og af hæmning af den renale tubulære reabsorption af calcium.
The calcium-lowering effect of calcitonin is caused both by a decrease in the efflux of calcium from the bone to the ECF and inhibition of renal tubular reabsorption of calcium.
Generelle karakteristika ved det aktive stof Laksecalcitonin absorberes og elimineres hurtigt.
General characteristics of the active substance Salmon calcitonin is rapidly absorbed and eliminated.
Plasma- proteinbindingen er 30- 40%.
Plasma protein binding is 30 to 40%.
Patientkarakteristika Der er en sammenhæng mellem den subkutane dosis af calcitonin og maksimale plasmakoncentrationer.
Characteristics in patients There is a relationship between the subcutaneous dose of calcitonin and peak plasma concentrations.
Efter parenteral administration af 100 IE calcitonin ligger de maksimale plasmakoncentrationer på mellem 200- 400 pg/ ml.
Following parenteral administration of 100 I. U. calcitonin, peak plasma concentration lies between about 200 and 400 pg/ ml.
6/ 31 6.
6/ 30 6.
6. 6 Eventuelle instruktioner vedrørende anvendelse og håndtering < samt bortskaffelse >
6.6 Instructions for use and handling< and disposal >
7/ 31 INJICERBART HUMANT CALCITONIN
7/ 30 INJECTABLE HUMAN CALCITONIN
8/ 31 1.
8/ 30 1.
Pulver og opløsning til injektionsvæske, opløsning (firmaspecifikt)
Powder and solvent for solution for injection (company specific).
Humant calcitonin kan administreres ved sengetid for at reducere incidensen af kvalme og opkastning, som kan opstå særligt ved behandlingens påbegyndelse.
Human calcitonin may be administered at bedtime to reduce the incidence of nausea or vomiting which may occur, especially at the initiation of therapy.
Anbefalet dosering er 0, 5 mg daglig eller 0, 25 mg to gange daglig i 2 til 4 uger administreret subkutant eller intramuskulært.
The recommended dosage is 0,5 mg. daily or 0,25 mg. twice daily for 2 to 4 weeks, administered subcutaneously or intramuscularly.
Dosis kan reduceres til 0, 25 mg daglig ved start af remobilisering.
The dose may be reduced to 0,25 mg. daily at the start of remobilisation.
Dosis bør tilpasses den enkelte patients behov.
The dosage should be individually adapted to the patient's requirements.
Generelt anbefales det, at behandlingen initieres med en dosis på 0, 5 mg subkutant eller intramuskulært, én gang daglig igennem adskillige uger.
As a rule, it is recommended that treatment be initiated with a dose of 0.5 mg injected subcutaneously or intramuscularly once a day, for several weeks.
0, 25 mg daglig eller 0, 5 mg 2- 3 gange ugentlig.
Depending on the patient's response, this dosage may subsequently be raised to 0.5 mg twice a day or reduced for maintenance therapy, e. g. to 0.25 mg daily or to 0.5 mg 2-3 times a week.
3- 6 måneder), såfremt der er behov for, at behandlingen fortsætter.
As an aid in evaluating the efficacy of human calcitonin determination of serum alkaline phosphatase and urinary hydroxyproline excretion should be performed prior to initiation of therapy, during the first three months, and at intervals (approximately 3-6 months) if treatment needs to be continued.
Dosisjusteringer bør baseres på klinisk og radiologisk udredning såvel som ændringer i serum alkalisk fosfatase og udskillelse af hydroxyprolin i urinen.
Adjustments in dose should be guided by clinical and radiological evidence, as well as changes in serum alkaline phosphatase and urinary hydroxyproline excretion.
Behandlingen bør fortsætte i mindst 6 måneder.
The treatment should be continued for 6 months or more.
Hvis der ved seponering af behandlingen opstår fornyet exacerbation (stigninger i de biokemiske parametre samt recidiverende symptomer eller radiologisk recidiv), bør behandlingen genoptages.
If withdrawal of therapy is followed by a renewed exacerbation (marked by an increase in the biochemical parameters and recurrence of symptoms or radiological signs), the treatment should be resumed.
9/ 31 Til akut behandling administreres ved langsom intravenøs injektion, og efter rehydrering, 0, 5 mg humant calcitonin hver 6. time.
For acute treatment 0.5 mg of human calcitonin is administered every 6 hours by slow intravenous injection, after previous rehydration.
Serum- calcium bør måles hver 6. time.
Serum calcium should be measured every 6 hours.
Behandlingen kan seponeres 12 timer efter, serum - calciumniveauerne er normaliserede.
Twelve hours after serum calcium levels have returned to normal, treatment can be discontinued.
Den terapeutiske effekt opnås sædvanligvis inden for de første 24 timer af behandlingen.
The therapeutic effect is usually obtained within the first 24 hours of treatment.
Hos patienter med inkomplette resultater, vil øgning af dosis ikke give yderligere reduktion i serum- calcium.
In patients with incomplete results, increasing the dosage does not result in a further reduction of serum calcium.
Der kan observeres ny stigning i serum- calcium få dage efter seponering af behandling.
A new rise in serum calcium is observed a few days after treatment is discontinued.
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.
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.
Dette gælder også patienter med ændret lever - funktion.
The same applies to patients with altered hepatic function.
Serum- calciumniveauet kan forbigående falde til under normalgrænsen efter administration af calcitonin, specielt efter påbegyndt behandling hos patienter med abnormt høj knogleomsætning.
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.
Det kan være nødvendigt at justere dosis af disse midler, da deres virkning kan påvirkes af ændringer i cellulære elektrolytkoncentrationer.
Dosages of these drugs may require adjustment in view of the fact that their effects may be modified by changes in cellular electrolyte concentrations.
Dyreundersøgelser har ikke dokumenteret, at humant calcitonin ikke har teratogent potentiale eller andre bivirkninger for embryo og/ eller foster.
There is no evidence from animal work that human calcitonin is free from either teratogenic potential or other adverse effects, on the embryo and/ or the foetus.
Calcitonin bør kun anvendes under graviditet hvis lægen skønner det absolut nødvendigt.
Calcitonin should be used during pregnancy only if treatment is considered absolutely essential by the physician.
Det vides ikke om stoffet udskilles i modermælk.
It is not known if the substance is excreted in human milk.
Patienten bør derfor advares om, at der kan opstå forbigående svimmelhed, og at de i så fald ikke bør føre motorkøretøj eller anvende maskiner.
Patients must therefore be warned that transient dizzines may occur, in which case they should not drive or use machines.
10/ 31 4. 8 Bivirkninger
10/ 30 4.8 Undesirable effects
Risiko for at udvikle neutraliserende antistoffer, er, selv ved langtids- behandling, lav, da aminosyrekæden er identisk med den for endogent humant calcitonin.
The risk of developing neutralising antibodies, even in the case of long-term therapy, is low because the amino acid sequence is identical to that of endogenous human calcitonin.
Kvalme, opkastning, rødmen og svimmelhed vides at være dosisafhængige, når calcitonin administreres parenteralt.
Nausea, vomiting, flushing and dizziness are known to be dose dependent when calcitonin is administered parenterally.
Der har dog ikke været indberettet tilfælde med overdosering.
However, no cases of overdosage have been reported.
H05BA03 (calcitonin, humant syntetisk).
H05BA03 (calcitonin, human synthetic).
5. 1 Farmakodynamiske egenskaber
11/ 30 5.1 Pharmacodynamic properties
11/ 31 Calcitonin er et calciotropisk hormon, som hæmmer knogleresorptionen ved direkte virkning på osteoklasterne.
Calcitonin is a calciotropic hormone, which inhibits bone resorption by a direct action on osteoclasts.
Ved at hæmme osteoklastaktiviteten via dets specifikke receptorer, nedsætter lakse calcitonin knogleresorptionen.
By inhibiting osteoclast activity via its specific receptors, human calcitonin decreases bone resorption.
Calcitonin reducerer markant knogleomsætningen i tilstande med øget knogleresorptionshastighed, såsom Paget’ s sygdom og akut knogletab på grund af pludselig immobilisering.
Calcitonin markedly reduces bone turnover in conditions with an increased rate of bone resorption such as Paget ‘ s disease disease and acute bone loss due to sudden immobilisation.
Det er i knoglehistomorfometriske undersøgelser med såvel mennesker som dyr vist, at der ikke er mineraliseringsdefekt ved calcitonin.
The absence of mineralisation defect with calcitonin has been demonstrated by bone histomorphometric studies both in man and in animals.
Der ses efter behandling med calcitonin fald i knogleresorptionen, vurderet ved en reduktion i urinudskillelsen af hydroxyprolin og deoxypyridinolin, hos både raske frivillige og patienter med knoglerelaterede forstyrrelser, inklusive Paget’ s sygdom og osteoporose.
Decreases in bone resorption as judged by a reduction in urinary hydroxyproline and deoxypyridinoline are observed following calcitonin treatment in both normal volunteers and patients with bone-related disorders, including Paget’ s disease and osteoporosis.
Efter intramuskulære og subkutane enkeltdoser af syntetisk humant calcitonin, er den systemiske optagelse af eksogent calcitonin hurtig; gennemsnitlige maksimale serumniveauer opnås inden for 20 minutter ved begge administrationsformer.
Following single intramuscular and subcutaneous doses of synthetic human calcitonin, systemic uptake of exogenous calcitonin is rapid; mean peak serum levels are attained within 20 minutes after both routes.
Maksimale serumkoncentrationer er i gennemsnit 4 ng/ ml efter i. m. injektion og 3- 5 ng/ ml efter subkutan injektion af 0, 5 mg calcitonin.
Peak serum concentrations average 4 ng/ ml after i. m. and 3-5 ng/ ml after subcutaneous injection of 0.5 mg doses.
I. m. og s. c. doser (0, 5 mg) er bioækvivalente med hensyn til serum AUC’ er.
The i. m. and s. c. doses (0.5 mg) are bioequivalent in terms of serum AUCs.
Maksimale koncentrationer og AUC - værdier af eksogent calcitonin i serum øges proportionelt med subkutane doser på 0, 25 mg og 0, 50 mg af syntetisk humant calcitonin.
Peak concentrations and AUC values of exogenous calcitonin in serum increases proportionally with subcutaneous doses of 0.25 mg and 0.50 mg of synthetic human calcitonin.
Eksogent calcitonin elimineres hurtigt fra kredsløbet, gennemsnitlig tilsyneladende halveringstid er 1, 1 time efter i. m. administration og 1, 1- 1, 4 time efter subkutan administration.
Exogenous calcitonin is rapidly eliminated from the circulation, mean apparent half-lives being 1.1 hours after i. m. and 1.1 - 1.4 hours after subcutaneous. administration.
600 ml/ min under konstant intravenøs infusion af humant calcitonin.
Under steady-state conditions, a mean metabolic clearance of about 600 ml/ min was maintained during constant intravenous infusion of human calcitonin.
Efter enkelt intravenøs injektion sås gennemsnitlig værdi på 720 ml/ min.
After single intravenous injection, a mean value of 720 ml/ min was observed.
Det tilsyneladende fordelingsrum er i gennemsnit 11, 4 l, hvilket svarer til 0, 15 l/ kg beregnet for en kropsvægt på 75 kg.
The apparent volume of distribution averages 11.4 l, which corresponds to 0.15 l/ kg, calculated for a body weight of 75 kg.
Efter enkelt intravenøs injektion af syntetisk humant I- calcitonin, udskilles 95% af dosis i 48- timers urinen; 2, 4% af dosis udskilles som uændret I- calcitonin og resten som iodide nedbrydningsprodukter.
Following single intravenous injection of synthetic human I-calcitonin, 95% of the dose is excreted in the 48-hour urine; 2.4% of the dose is accounted for by unchanged I-calcitonin and the rest by iodinated degradation products.
Humant calcitonin nedbrydes primært og næsten udelukkende i nyrerne, hvor der dannes farmakologisk inaktive fragmenter af molekylet.
Human calcitonin is primarily and almost exclusively degraded in the kidneys, forming pharmacologically inactive fragments of the molecule.
Humant calcitonin er ikke direkte mutagent i bakterielle eller eukaryotide systemer in vitro eller in vivo test med pattedyr.
Human calcitonin is not directly mutagenic in bacterial or eukaryotic systems in vitro or in mammalian tests in vivo.
Der var positive resultater i bakterielle mutagenicitetstest ved tilstedeværelse af et metabolisk aktiveringssystem.
It did give positive results in bacterial mutagenicity tests in the presence of a metabolic activating system.
Disse fund er sandsynligvis en konsekvens af oxidering af aminosyrer, der frigives ved hydrolyse eller skyldes en forøget bakterievækst ved hydrolyseprodukter, og anses ikke for en indikation af at humant calcitonin mutagent.
These findings are most probably a consequence of the oxidation of amino acids released by hydrolysis or a reflection of an alteration of bacterial growth by hydrolysis products and are not considered an indication of human calcitonin mutagenicity.
Der er ikke udført længerevarende studier med humant calcitonin.
No long-term carcinogenicity studies have been conducted with human calcitonin.
Der er ikke udført dyrereproduktionsstudier med humant calcitonin.
Animal reproduction studies have not been performed with human calcitonin.
12/ 31 6. 1 Fortegnelse over hjælpestoffer
6.1 List of excipients
6. 4 Særlige opbevaringsforhold
12/ 30 6.4 Special precautions for storage
13/ 31 INJICERBART ELCATONIN
13/ 30 INJECTABLE ELCATONIN
14/ 31 1.
14/ 30 1.
Elcatonin er en ålecalcitonin analog
Elcatonin is an analog of eel calcitonin
Elcatonin er indiceret til: • Forebyggelse af akut knogletab på grund af pludselig immobilisering som hos patienter med nylige osteoporotiske frakturer • Paget’ s sygdom • Hypercalcæmi på grund af malign sygdom
• Prevention of acute bone loss due to sudden immobilisation such as in patients with recent osteoporotic fractures
Til intramuskulær eller intravenøs infusion (præparat specifikt) hos personer, der er fyldt 18 år eller ældre.
For intramuscular or intravenous (product specific) use in individuals aged 18 years or more.
For at reducere incidensen af kvalme og opkastning, som kan opstå særligt ved behandlingens påbegyndelse, kan elcatonin administreres ved sengetid.
Elcatonin may be administered at bedtime to reduce the incidence of nausea or vomiting which may occur, especially at the initiation of therapy.
Anbefalet dosering er 40 IE daglig i 2- 4 uger administreret intramuskulært.
The recommended dosage is 40 I. U. daily for 2 to 4 weeks, administered intramuscularly.
Dosis kan reduceres til 40 IE hver 2. dag efter påbegyndt remobilisering.
The dose may be reduced to 40 I. U. every other day at the start of remobilisation.
Den anbefalede dosis er 40 IE pr. dag administreret intramuskulært; der er dog opnået klinisk og biokemisk effekt ved en minimumsdosering på 40 IE 3 gange ugentlig.
The recommended dosage is 40 IU per day administered intramuscularly, however, a minimum dosage regimen of 40 IU three times a week has achieved clinical and biochemical improvement.
Effekt af elcatonin kan monitoreres ved måling af relevante markører for knoglegendannelse, såsom serum alkalisk fosfotase eller udskillelse af hydroxyprolin eller deoxypyridolin i urinen.
The effect of calcitonin may be monitored by measurement of suitable markers of bone remodeling such as serum alkaline phosphatase or urinary hydroxyproline or deoxypyridinoline.
Varigheden af behandlingen afhænger af indikationen og patientens respons, men bør som minimum være 3 måneder.
The duration of treatment depends on the indication for treatment and the patient´s response, but should be a minimum of 3 months.
Den anbefalede startdosis er 40 IE hver 6. - 8. time administreret ved intramuskulær injektion.
The recommended starting dose is 40 IU every 6 to 8 hours by intramuscular injection.
Desuden kan elcatonin administreres ved intravenøs injektion efter forudgående rehydrering.
In addition, elcatonin could be administered by intravenous injection after previous rehydration.
Hvis respons ikke er tilfredsstillende efter 1 eller 2 dage, kan dosis øges til maksimalt 80 IE hver 6. - 8. time.
15/ 30 If the response is not satisfactory after one or two days, the dose may be increased to a maximum of 80 IU every 6 to 8 hours.
15/ 31 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.
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.
Der bør udføres hudtest af patienter, hvor der er mistanke om overfølsomhed over for calcitonin, inden behandling med elcatonin påbegyndes.
Skin testing should be conducted in patients with suspected sensitivity to calcitonin prior to their treatment with elcatonin.
Serumcalcium- niveauet kan forbigående falde til under normalgrænsen efter administration af elcatonin, specielt efter påbegyndt behandling hos patienter med abnormt høj knogleomsætning.
Serum calcium levels may be transiently decreased to below normal levels following administration of elcatonin, notably upon initiation of therapy in patients with abnormally high rates of bone turnover.
Brug af calcitonin i kombination med bisfosfonater kan resultere i en additiv calcium- sænkende effekt.
The use of calcitonin in combination with bisphosphonates may result in an additive calcium-lovering effect.
Elcatonin er ikke undersøgt hos gravide kvinder.
Elcatonin has not been studied in pregnant women.
Elcatonin bør kun anvendes under graviditet, hvis lægen skønner det absolut nødvendigt.
Elcatonin should be used during pregnancy only if treatment is considered absolutely essential by the physician.
4. 7 Virkninger på evnen til at føre motorkøretøj eller betjene maskiner
4.7 Effects on ability to drive and use machines No data exist on the effects of injectable elcatonin on the ability to drive and use machines.
Der er ingen data vedrørende effekten af injektion med calcitonin på evnen til at føre motorkøretøj og anvende maskiner.
Injectable elcatonin may cause transient dizzines (see 4.8.
Injektion med elcatonin kan forårsage forbigående svimmelhed (se punkt 4. 8 ” Bivirkninger ”), som kan påvirke patientens reaktionsevne.
Undesirable effects) which may impair the reaction of the patient.
4. 8 Bivirkninger Bivirkninger observeret under behandling med elcatonin er de samme som rapporteret ved dosering med lakse calcitonin.
4.8 Undesirable effects The undesirable effects observed during treatment with elcatonin are similar to those reported after administration of salmon calcitonin.
16/ 31 Meget almindelig:
16/ 30 Very common:
10% af patienterne behandlet med elcatonin.
Nausea with or without vomiting is noted in approximately 10% of patients treated with calcitonin.
Usædvanlig: lokale inflammationsreaktioner ved administrationsstedet for den intravenöseeller intramuskulære injektion.
General disorders and administration site conditions Uncommon: local inflammatory reactions at the site of subcutaneous or intramuscular injection
Kvalme, opkastning, rødme og svimmelhed vides at være dosisafhængige når calcitonin administreres parenteralt.
Nausea, vomiting, flushing and dizziness are known to be dose dependent when calcitonin is administered parenterally.
H05B A04 (elcatonin).
H05B A04 (elcatonin).
5. 1 Farmakodynamiske egenskaber
17/ 30 5.1 Pharmacodynamic properties
Calcitonin er et calciotropisk hormon, som hæmmer knogleresorptionen ved direkte virkning på osteoklasterne.
Calcitoinin is a calciotropic hormone, which inhibits bone resorption by a direct action on osteoclasts.
17/ 31 calcitonin knogleresorptionen.
By inhibiting osteoclast activity via its specific receptors, calcitoinin decreases bone resorption.
Calcitonin reducerer markant knogleomsætningen i tilstande med øget knogleresorptionshastighed, såsom Paget’ s sygdom og akut knogletab på grund af pludselig immobilisering.
Calcitoinin markedly reduces bone turnover in conditions with an increased rate of bone resorption such as Paget ‘ s disease and acute bone loss due to sudden immobilisation.
Det er i knoglehistomorfometriske undersøgelser af såvel mennesker som dyr vist, at der ikke er mineraliseringsdefekt ved elcatonin.
The absence of mineralisation defect with calcitonin has been demonstrated by bone histomorphometric studies both in man and in animals.
Der ses efter behandling med calcicatonin fald i knogleresorptionen, vurderet ved en reduktion i urinudskillelsen af hydroxyprolin og deoxypyridinolin, hos både raske frivillige og patienter med knoglerelaterede forstyrrelser, inklusiv Paget’ s sygdom og osteoporose.
Decreases in bone resorption as judged by a reduction in urinary hydroxyproline and deoxypyridinoline are observed following calcitoinin treatment in both normal volunteers and patients with bone-related disorders, including Paget’ s disease and osteoporosis.
Calcitonins calcium- sænkende effekt forårsages både af et fald i calciumeffusion fra knoglerne til den ekstracellulære væske og af hæmning af den renale tubulære reabsorption af calcium.
The calcium-lowering effect of calcitoinin is caused both by a decrease in the efflux of calcium from the bone to the ECF and inhibition of renal tubular reabsorption of calcium.
Generelle karakteristika ved det aktive stof Elcatonin absorberes og elimineres hurtigt.
General characteristics of the active substance Elcatonin is rapidly absorbed and eliminated.