natgillin/translations-raw huggingface dataset:
Det anvendes til patienter med risiko for frakturer (knoglebrud), herunder patienter, som for nylig har brækket hoften ved et mindre traume som f. eks. et fald • Pagets knoglesygdom, som er en sygdom, der ændrer den normale knoglevækst.
It is used in patients who are at risk of fracture (bone breaks), including patients who have recently broken their hip in a minor trauma, such as a fall; • Paget’ s disease of the bone, a disease where the normal process of bone growth is changed.
Aclasta gives som en 100 ml infusion over mindst 15 minutter.
Aclasta is given as a 100 ml infusion, lasting at least 15 minutes.
Hos patienter, der behandles for osteoporose, kan dette gentages en gang om året.
This can be repeated once a year in patients being treated for osteoporosis.
Patienter, som har brækket hoften, bør have Aclasta i mindst to uger efter operationen, for at bruddet kan heles.
Patients who have broken their hip should receive Aclasta at least two weeks after the operation to repair the fracture.
Til patienter med Pagets sygdom skal der kun gives én Aclasta- infusion.
For Paget’ s disease, only one infusion of Aclasta is given.
Infusionens virkning varer et år eller mere.
The effect of the infusion lasts for a year or more.
Patienterne skal drikke rigelig væske både før og efter behandlingen.
Patients must have adequate fluids before and after treatment.
Det anbefales desuden at give alle patienter, der behandles med Aclasta, tilskud af D- vitamin og calcium.
Adequate supplements of vitamin D and calcium are also recommended for all patients receiving Aclasta.
Desuden bør patienter med Pagets sygdom indtage mindst 500 mg calcium to gange dagligt i mindst 10 dage efter behandlingen, og patienter, som har brækket hoften, bør indtage en stor dosis D- vitamin (50 000 til 125 000 internationale enheder) enten gennem munden eller ved injektion i en muskel inden den første infusion.
In addition, patients with Paget’ s disease should take at least 500 mg calcium twice a day for at least 10 days following treatment, and patients who have broken their hip should receive a large dose of vitamin D (50,000 to 125,000 international units) by mouth or by injection into a muscle before their first infusion.
Brug af paracetamol eller ibuprofen (antiinflammatoriske lægemidler) kort efter indgivelsen af Aclasta kan reducere symptomer som feber, muskelsmerter, influenzalignende symptomer, ledsmerter og hovedpine i de første tre dage efter infusionen.
Using paracetamol or ibuprofen (anti-inflammation medicines) shortly after Aclasta can reduce symptoms such as fever, muscle pain, flu-like symptoms, joint pain and headache in the three days following the infusion.
Aclasta anbefales ikke til patienter med alvorlige nyreproblemer.
Aclasta is not recommended for use in patients who have severe problems with their kidneys.
Ved behandling af Pagets knoglesygdom må Aclasta kun anvendes af en læge med erfaring i behandling af denne sygdom.
In the treatment of Paget’ s disease of the bone, Aclasta must only be used by a doctor who has experience in the treatment of the disease.
Osteoporose forekommer, når der ikke er tilstrækkelig ny knoglevækst til at erstatte det knoglevæv, der nedbrydes naturligt.
Gradually, the bones become thin and fragile, and more likely to break (fracture).
Knoglerne bliver gradvist tyndere og mere skrøbelige, og de kan lettere 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
In women, osteoporosis is more common after the menopause, when the levels of the female hormone oestrogen 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Reproduction is authorised provided the source is acknowledged brække.
Reproduction is authorised provided the source is acknowledged. fall.
Ved Pagets sygdom nedbrydes knoglevævet hurtigere, og når det genopbygges, er det mere skrøbeligt end normalt.
In Paget’ s disease the bone breaks down more quickly, and when it grows back, it is weaker than normal.
Det aktive stof i Aclasta, zoledronsyre, er et biphosphonat.
The active substance in Aclasta, zoledronic acid, is a bisphosphonate.
Det standser aktiviteten af osteoklasterne, som er de celler i kroppen, der medvirker til at nedbryde knoglevævet.
It stops the action of the osteoclasts, the cells in the body that are involved in breaking down the bone tissue.
Dette medfører mindre knogletab ved osteoporose og mindre sygdomsaktivitet ved Pagets sygdom.
This leads to less bone loss in osteoporosis and less disease activity in Paget’ s disease.
Da det aktive stof i Aclasta er det samme som det aktive stof i Zometa, blev nogle af de data, der blev fremlagt for Zometa, taget i betragtning ved vurderingen af Aclasta.
Because the active substance in Aclasta is the same as the active substance in Zometa, some of the data presented for Zometa were taken into account when assessing Aclasta.
Ved behandlingen af osteoporose blev virkningen af Aclasta, givet én gang om året, sammenlignet med placebo (uvirksom behandling) i to hovedundersøgelser.
For the treatment of osteoporosis, the effects of Aclasta given once a year have been compared with those of placebo (a dummy treatment) in two main studies.
Den første undersøgelse omfattede næsten 8 000 ældre kvinder med osteoporose og så nærmere på antallet af ryghvirvel - og hoftefrakturer i en periode på tre år.
The first involved almost 8,000 elderly women with osteoporosis, looking at the number of spine and hip fractures over three years.
Den anden undersøgelse omfattede 2 127 mænd og kvinder med osteoporose, som var over 50 år og for nylig havde brækket hoften.
The second involved 2,127 men and women with osteoporosis who were aged over 50 years and had recently broken their hip, and looked at the number of fractures over up to five years.
Undersøgelsen så nærmere på antallet af frakturer i en periode på fem år.
In both studies, the patients were allowed to take other medicines for osteoporosis, but not other bisphosphonates.
Aclastas virkning på Pagets sygdom blev undersøgt hos i alt 357 patienter i to undersøgelser, hvor det blev sammenlignet med risedronat (et andet biphosphonat) over en periode på seks måneder.
In Paget’ s disease, Aclasta has been studied in a total of 357 patients in two studies, where it was compared with risedronate (another bisphosphonate) over six months.
Patienterne fik enten en infusion af Aclasta, eller de fik risedronat en gang dagligt i to måneder.
The patients received one infusion of Aclasta or they received risedronate once a day for two months.
Det vigtigste mål for virkningen var, hvorvidt blodets indhold af serum alkalisk fosfatase (et enzym, der medvirker ved knoglenedbrydelsen) blev normaliseret eller reduceret med mindst 75% i retning mod normalværdierne.
The main measure of effectiveness was whether blood levels of serum alkaline phosphatase (an enzyme involved in the breakdown of bone) returned to normal or fell by at least 75% of the way back to normal levels.
Hvilke fordele viste Aclasta i løbet af undersøgelserne?
What benefit has Aclasta shown during the studies?
Til behandling af osteoporose var Aclasta mere effektiv end placebo til at reducere antallet af frakturer.
In osteoporosis, Aclasta was more effective than placebo at reducing the number of fractures.
I undersøgelsen af ældre kvinder blev risikoen for ryghvirvelfrakturer reduceret med 70% hos de patienter, der fik Aclasta (uden anden medicin mod osteoporose) i tre år, sammenlignet med dem, der fik placebo.
In the study of elderly women, the risk of spine fractures was reduced by 70% in patients taking Aclasta (without any other medicines for osteoporosis) over three years, compared with those taking placebo.
Risikoen for hoftefrakturer blev reduceret med 41%, når alle kvinder, der fik Aclasta (med eller uden anden osteoporosemedicin), blev sammenlignet med dem, der fik placebo.
There was a 41% risk reduction in hip fractures, when comparing all women taking Aclasta (with or without other osteoporosis medicines) with those taking placebo.
I undersøgelsen af mænd og kvinder, som havde brækket hoften, fik 9% af de patienter, der fik Aclasta, en fraktur (92 ud af 1 065), sammenlignet med 13% af de patienter, der fik placebo (139 ud af 1 062).
In the study of men and women who had broken their hip, 9% of the patients receiving Aclasta had a fracture (92 out of 1,065), compared with 13% of the patients receiving placebo (139 out of 1,062).
Dette er en reduktion på 35% af risikoen for frakturer hos patienter, som behandles med Aclasta.
This represents a 35% reduction in the risk of fracture in patients receiving Aclasta.
Ved Pagets sygdom var Aclasta mere effektivt end risedronat.
In Paget’ s disease, Aclasta was more effective than risedronate.
Efter seks måneder var andelen af patienter, der responderede på behandlingen, 95% i den ene undersøgelse og 97% i den anden undersøgelse, sammenlignet med 75% og 73% af de patienter, der fik risedronat.
After six months, the proportion of patients who had responded to treatment was 95% in one study and 97% in the other, compared with 75% and 73% of the patients who received risedronate.
De fleste bivirkninger ved Aclasta opstår sædvanligvis inden for de første tre dage efter infusionen og optræder i mindre omfang ved efterfølgende infusioner.
Most side effects with Aclasta tend to occur within the first three days after infusion, becoming less common with repeated infusions.
Den mest almindelige bivirkning ved Aclasta (set hos mere end 1 patient ud af 10) var feber.
The most common side effect with Aclasta (seen in more than 1 patient in 10) is fever.
Den fuldstændige liste over bivirkningerne ved Aclasta fremgår af indlægssedlen.
For the full list of all side effects reported with Aclasta, see the Package Leaflet.
Aclasta bør ikke anvendes til patienter, der kan være overfølsomme (allergiske) overfor zoledronsyre, andre biphosphonater eller andre af indholdsstofferne.
Aclasta should not be used in people who may be hypersensitive (allergic) to zoledronic acid, to other bisphosphonates or to any of the other ingredients.
Aclasta bør ikke gives til patienter med hypocalcæmi (lavt calciumindhold i blodet) eller til patienter, der er gravide eller ammer.
Aclasta should not be used in patients with hypocalcaemia (low blood calcium levels) or in pregnant or breast-feeding women.
Som ved alle biphosphonater har patienter, der får Aclasta, risiko for nyreproblemer, reaktioner på infusionsstedet og osteonekrose (dødt knoglevæv) i kæben.
As with all bisphosphonates, patients taking Aclasta may also be at risk of kidney problems, reactions at the site of infusion and osteonecrosis (death of bone tissue) in the jaw.
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at fordelene ved Aclasta er større end risiciene ved behandling af osteoporose hos mænd og postmenopausale kvinder med øget risiko for knoglebrud, herunder patienter, som for nylig har brækket hoften ved et mindre traume, samt til behandling af Pagets knoglesygdom.
The Committee for Medicinal Products for Human Use (CHMP) decided that Aclasta’ s benefits are greater than its risks for the treatment of osteoporosis in post-menopausal women and in men, at increased risk of fracture including those with a recent low-trauma hip fracture, and of Paget’ s disease of the bone.
Udvalget anbefalede udstedelse af markedsføringstilladelse for Aclasta.
The Committee recommended that Aclasta be given marketing authorisation.
2/ 3 Hvilke foranstaltninger træffes der for at sikre en risikofri anvendelse af Aclasta?
Which measures are being taken to ensure the safe use of Aclasta?
Firmaet udleverer lignende pakker til patienter, hvori lægemidlets bivirkninger forklares, og det angives, hvornår patienten bør søge læge.
The company that makes Aclasta will provide educational packs for doctors who prescribe Aclasta for osteoporosis, reminding them how the medicine should be used, and similar packs for patients, which explain the medicine’ s side effects and when they should contact their doctor.
Europa- Kommissionen udstedte en markedsføringstilladelse for Aclasta med gyldighed i hele Den Europæiske Union til Novartis Europharm Limited den 15. april 2005.
The European Commission granted a marketing authorisation valid throughout the European Union for Aclasta to Novartis Europharm Limited on 15 April 2005.
Den fuldstændige EPAR for Aclasta findes her.
2/ 3 The full EPAR for Aclasta is available here.
Dette sammendrag blev sidst ajourført i 09- 2008.
This summary was last updated in 09-2008.
Intravenøs anvendelse
bottle (plastic)
Flaske 100 ml (plastic)
100 ml
BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL EN SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET SOM SKAL IMPLEMENTERES AF MEDLEMSLANDENDE • BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL EN SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET SOM SKAL IMPLEMENTERES AF MEDLEMSLANDENDE
CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES • CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
Medlemslandende skal sikre at uddannelsesprogrammet, der er implementeret til den godkendte indikation, behandling af postmenopausal osteoporose, er udvidet til læger, der forventes at udskrive recepter til den nye indikation: behandling af osteoporose hos postmenopausale kvinder og mænd med øget risiko for fraktur, inklusive personer med en nylig lavenergi hoftefraktur.
The Member States shall ensure that the educational programme implemented for the authorised indication of treatment of post-menopausal osteoporosis, is extended to the potential prescribers concerned by the new indication: treatment of osteoporosis in post-menopausal women and men at increased risk of fracture, including those with a recent low-trauma hip fracture.
Lægeundervisningsmaterialet skal indeholde følgende hovedelementer: • Produktresumeet • Informationskort med følgende hovedbudskaber: o Nødvendigheden at måle serumcreatinin inden behandling med Aclasta o Anbefaling om ikke at anvende Aclasta hos patienter med creatininclearance < 35 ml/ min o Kontraindikationer hos gravide og ammende kvinder grundet potentiel teratogenicitet o Nødvendigheden af at sikre passende hydrering af patienten o Nødvendigheden af at infusere Aclasta langsomt over en periode på mindst 15 minutter o Doseringsregime én gang årligt o Tilstrækkelig calcium - og Vitamin D- optag er anbefalet i forbindelse med Aclasta - administration o Nødvendigheden af passende fysisk aktivitet, rygestop og sund diæt • Patientinformationspakke
The physician educational material should contain the following key elements: • The Summary of Product Characteristics • Reminder card with the following key messages: o Need to measure serum creatinine before treatment with Aclasta o Recommendation not to use Aclasta in patients with creatinine clearance < 35 ml/ min o Contraindication in pregnancy and in breast-feeding women due to potential teratogenicity o Need to ensure appropriate hydration of the patient o Need to infuse Aclasta slowly over a period of no less than 15 minutes o One-yearly dosing regime o Adequate calcium and vitamin D intake are recommended in association with Aclasta administration. o Need for appropriate physical activity, non-smoking and healthy diet • Patient information pack
Patientinformationspakken skal stilles til rådighed og indeholde følgende hovedbudskaber: • Indlægsseddel • Kontraindikation hos gravide og ammende kvinder • Behovet for tilstrækkeligt indtag af calcium - og Vitamin D- tilskud, passende fysisk aktivitet, rygestop og sund diæt • Væsentlige tegn og symptomer på alvorlige bivirkninger • Hvornår det er nødvendigt at opsøge sundhedspersonale
The patient information pack should be provided and contain the following key messages: • Package leaflet • Contraindication in pregnancy and in breast-feeding women • Need for adequate calcium and vitamin D supplementation, appropriate physical activity, non- smoking and healthy diet • Key signs and symptoms of serious adverse events • When to seek attention from the health care provider
Hver flaske med 100 ml opløsning indeholder 5 mg vandfri zoledronsyre, svarende til 5, 330 mg zoledronsyremonohydrat.
Each bottle with 100 ml of solution contains 5 mg zoledronic acid anhydrous, corresponding to 5.330 mg zoledronic acid monohydrate.
1 ml opløsning indeholder 0, 05 mg vandfri zoledronsyre, svarende til 0, 0533 mg zoledronsyremonohydrat.
One ml solution contains 0.05 mg zoledronic acid anhydrous, corresponding to 0.0533 mg zoledronic acid monohydrate.
Behandling af osteoporose • hos postmenopausale kvinder • hos mænd med øget risiko for knoglebrud, inklusive personer med en nylig lavenergi hoftefraktur.
Treatment of osteoporosis • in post-menopausal women • in men at increased risk of fracture, including those with a recent low-trauma hip fracture.
Behandling af Pagets sygdom af knoglerne.
Treatment of Paget’ s disease of the bone.
Til behandling af postmenopausal osteoporose og osteoporose hos mænd er den anbefalede dosis en enkelt intravenøs infusion af 5 mg Aclasta administreret en gang om året.
For the treatment of post-menopausal osteoporosis and osteoporosis in men, the recommended dose is a single intravenous infusion of 5 mg Aclasta administered once a year.
5. 1).
In patients with a recent low-trauma hip fracture, it is recommended to give the Aclasta infusion two or more weeks after hip fracture repair (see section 5.1).
Til behandling af Pagets sygdom bør Aclasta kun ordineres af læger med erfaring i behandling af Pagets sygdom af knoglerne.
For the treatment of Paget’ s disease, Aclasta should be prescribed only by physicians with experience in treatment of Paget’ s disease of the bone.
Data for specifik efterbehandling er ikke tilgængelige.
Retreatment of Paget’ s disease: specific retreatment data are not available.
5. 1).
After a single treatment with Aclasta in Paget’ s disease, an extended remission period is observed in responding patients (see section 5.1).
Aclasta (5 mg) i 100 ml infusionsklar opløsning) administreres via en infusionsslange og ved en konstant infusionshastighed.
Aclasta (5 mg in 100 ml ready-to-infuse solution) is administered via a vented infusion line and given at a constant infusion rate.
6. 6.
For information on the infusion of Aclasta, see section 6.6.
Det anbefales at indtage tilstrækkeligt med calcium og D- vitamin i forbindelse med administration af Aclasta.
2 Adequate calcium and vitamin D intake are recommended in association with Aclasta administration.
4. 4).
In addition, in patients with Paget’ s disease, it is strongly advised that adequate supplemental calcium corresponding to at least 500 mg elemental calcium twice daily is ensured for at least 10 days following Aclasta administration (see section 4.4).
Det anbefales at give en støddosis D- vitamin på 50. 000 til 125. 000 IE oralt eller intramuskulært før den første Aclasta- infusion hos patienter med en nylig lavenergi hoftefraktur.
In patients with a recent low-trauma hip fracture, a loading dose of 50,000 to 125,000 IU of vitamin D given orally or via the intramuscular route is recommended prior to the first Aclasta infusion.
Incidensen af postdosissymptomer inden for de første tre dage efter administration af Aclasta kan reduceres ved administration af paracetamol eller ibuprofen kort efter administration af Aclasta.
The incidence of post-dose symptoms occurring within the first three days after administration of Aclasta can be reduced with the administration of paracetamol or ibuprofen shortly following Aclasta administration.
4. 4) Brug af Aclasta til patienter med kreatininclearance < 35 ml/ min anbefales ikke på grund af begrænset klinisk erfaring i denne population.
Patients with renal impairment (see section 4.4) Use of Aclasta in patients with creatinine clearance < 35 ml/ min is not recommended due to limited clinical experience in this population.
Dosisjustering er ikke nødvendig til patienter med kreatininclearance ≥ 35 ml/ min.
No dose adjustment is necessary in patients with creatinine clearance ≥ 35 ml/ min.
5. 2)
Patients with hepatic impairment No dose adjustment is required (see section 5.2).
Ældre (≥ 65 år) Dosisjustering er ikke nødvendig, da biotilgængelighed, fordeling og elimination var ens hos ældre patienter og yngre forsøgspersoner.
Elderly patients (≥ 65 years) No dose adjustment is necessary since bioavailability, distribution and elimination were similar in elderly patients and younger subjects.
Børn og unge Aclasta bør ikke anvendes til børn og unge under 18 år p. g. a. utilstrækkelig dokumentation for sikkerhed og virkning.
Children and adolescents Aclasta is not recommended for use in children and adolescents below 18 years of age due to lack of data on safety and efficacy.
Overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne eller over for andre bisfosfonater.
Hypersensitivity to the active substance or to any of the excipients or to any bisphosphonates.
4. 4).
Aclasta is contraindicated for patients with hypocalcaemia (see section 4.4).
4. 6).
Aclasta is contraindicated during pregnancy and in breast-feeding women (see section 4.6).
Dosering på 5 mg zoledronsyre skal administreres over mindst 15 minutter.
The dose of 5 mg zoledronic acid must be administered over at least 15 minutes.
Aclasta anbefales ikke til patienter med svær nedsat nyrefunktion (kreatininclearance < 35 ml/ min) på grund af begrænset klinisk erfaring i denne population.
Aclasta is not recommended in patients with severe renal impairment (creatinine clearance < 35 ml/ min) due to limited clinical experience in this population.
Patienterne bør have målt deres serumkreatininniveau før behandling med Aclasta.
Patients should have their serum creatinine level measured before receiving Aclasta.
Det er specielt vigtigt for ældre patienter og patienter, som er i behandling med diuretika.
This is especially important in the elderly and for patients receiving diuretic therapy.
4. 5.
Caution is indicated when Aclasta is administered in conjunction with medicinal products that can significantly impact renal function (e. g. aminoglycosides or diuretics that may cause dehydration), see section 4.5.
Eksisterende hypocalcæmi skal behandles med tilstrækkelig indgivelse af calcium og D- vitamin, før behandling med Aclasta initieres (se pkt.
Pre-existing hypocalcaemia must be treated by adequate intake of calcium and vitamin D before initiating therapy with Aclasta (see section 4.3).
Andre forstyrrelser af mineralmetabolismen skal ligeledes behandles effektivt (f. eks. hypoparathyroidisme, intestinal calciummalabsorption).
Other disturbances of mineral metabolism must also be effectively treated (e. g. diminished parathyroid reserve, intestinal calcium malabsorption).
Forhøjet knogleomsætning er karakteristisk for Pagets sygdom af knoglerne.
3 Elevated bone turnover is a characteristic of Paget’ s disease of the bone.
4. 8).
Due to the rapid onset of effect of zoledronic acid on bone turnover, transient hypocalcaemia, sometimes symptomatic, may develop and is usually maximal within the first 10 days after infusion of Aclasta (see section 4.8).
3 Det anbefales at indtage tilstrækkeligt med calcium og D- vitamin i forbindelse med administration af Aclasta.
Adequate calcium and vitamin D intake are recommended in association with Aclasta administration.
4. 2).
In addition, in patients with Paget's disease, it is strongly advised that adequate supplemental calcium corresponding to at least 500 mg elemental calcium twice daily is ensured for at least 10 days following Aclasta administration (see section 4.2).
Patienterne bør informeres om symptomer på hypocalcæmi og få passende klinisk monitorering i risikoperioden.
Patients should be informed about symptoms of hypocalcaemia and receive adequate clinical monitoring during the period of risk.
Alvorlig og til tider inhabiliterende knogle -, led - og/ eller muskelsmerter er sjældent blevet rapporteret hos patienter behandlet med biphosphonater, herunder Aclasta.
Severe and occasionally incapacitating bone, joint and/ or muscle pain have been infrequently reported in patients taking bisphosphonates, including Aclasta.