natgillin/translations-raw huggingface dataset:
What measures are being taken to ensure the safe and effective use of Movymia?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Movymia?
The full EPAR for Movymia can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Movymia je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
This was considered sufficient to conclude that Movymia will behave in the same way in terms of effectiveness and safety.
To je zadostovalo za zaključek, da se bo zdravilo Movymia z vidika učinkovitosti in varnosti vedlo na enak način.
It also increases the absorption of calcium from food and prevents too much calcium being lost in the urine.
Poleg tega poveča absorpcijo kalcija iz hrane in preprečuje izgubo velike količine kalcija z urinom.
Patients may inject themselves once they have been trained.
Bolniki si lahko zdravilo injicirajo sami, potem ko so bili za to ustrezno usposobljeni.
This is a summary of the European public assessment report (EPAR) for Movymia.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Movymia.
• men and women who are at an increased risk of fractures due to long-term treatment with glucocorticoids (a type of steroid).
• moških in ženskah, ki imajo povečano tveganje za zlome zaradi dolgotrajnega zdravljenja z glukokortikoidi (vrsto steroida).
The most common side effect with Movymia (seen in more than 1 patient in 10) is pain in the arms or legs.
Najpogostejši neželeni učinek zdravila Movymia (opažen pri več kot 1 bolniku od 10) so bolečine v rokah ali nogah.
A study in 54 healthy women has shown that the same doses of the two medicines given by injection under the skin produced similar levels of the active substance teriparatide in the body.
Študija na 54 zdravih ženskah je pokazala, da so enaki odmerki obeh zdravil, dani z injiciranjem pod kožo, povzročili podobno raven učinkovine teriparatid v telesu.
What benefits of Movymia have been shown in studies?
Kakšne koristi je zdravilo Movymia izkazalo v študijah?
It is not intended to provide practical advice on how to use Movymia.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
What are the risks associated with Movymia?
Kakšna tveganja so povezana z zdravilom Movymia?
Movymia must not be used in patients who have other bone diseases such as Paget's disease, bone cancer or bone metastases (cancer that has spread to the bone), patients who have had radiation therapy of the skeleton, or patients who have hypercalcaemia (high blood calcium levels), unexplained high levels of alkaline phosphatase (an enzyme) or severe kidney disease.
Zdravilo Movymia se ne sme uporabljati pri bolnikih, ki imajo druga obolenja kosti, kot so Pagetova bolezen, kostni rak ali metastaze v kosteh (rak, ki se je razširil na kosti), bolnikih, ki so bili na obsevanju okostja, ali bolnikih, ki imajo hiperkalciemijo (visoke ravni kalcija v krvi), tistih z nepojasnjeno visokimi ravnmi alkalne fosfataze (vrste encima) ali hudim obolenjem ledvic.
Thus, as for Forsteo, the benefit outweighs the identified risks and the Committee recommended that Movymia be given marketing authorisation.
Tako njegove koristi enako kot pri zdravilu Forsteo odtehtajo znana tveganja, zato je Odbor priporočil, da se za zdravilo Movymia izda dovoljenje za promet.
The two-year course of Movymia should be given only once during a patient's lifetime.
Dveletno zdravljenje z zdravilom Movymia se sme pri bolniku uporabiti le enkrat v življenju.
What is Movymia and what is it used for?
Kaj je zdravilo Movymia in za kaj se uporablja?
Other information about Movymia
Druge informacije o zdravilu Movymia
• women who have been through the menopause.
• ženskah po menopavzi.
For more information about treatment with Movymia, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Movymia preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Why is Movymia approved?
Zakaj je bilo zdravilo Movymia odobreno?
Movymia is a medicine used for the treatment of osteoporosis (a disease that makes bones fragile) in:
Zdravilo Movymia se uporablja za zdravljenje osteoporoze (bolezni, ki povzroča krhkost kosti) pri:
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Movymia have been included in the summary of product characteristics and the package leaflet.
Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Movymia upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
In these patients, Movymia has been shown to significantly reduce vertebral (spine) and non-vertebral fractures (broken bones), but not those of the hip;
Pri teh bolnicah je bilo dokazano, da zdravilo Movymia znatno zmanjšuje pojavnost zlomov vretenc (hrbtenice) in nevretenčnih zlomov (zlomov kosti), ne pa tudi zlomov kolka;
Because Movymia is a biosimilar medicine, the studies on effectiveness and safety of teriparatide carried out with Forsteo do not need to be repeated for Movymia.
Zdravilo Movymia je „podobno biološko zdravilo“, zato študij o učinkovitosti in varnosti teriparatida, izvedenih z zdravilom Forsteo, z zdravilom Movymia ni treba ponavljati.
Gradually, the bones become less dense and more likely to break.
Kosti se tako postopoma redčijo in postajajo krhkejše ter posledično bolj lomljive.
The reference medicine for Movymia is Forsteo.
Referenčno zdravilo za zdravilo Movymia je zdravilo Forsteo.
It acts like the hormone to stimulate bone formation by acting on osteoblasts (bone-forming cells).
Deluje enako kot hormon in vzpodbuja tvorbo kostnine tako, da deluje na osteoblaste (celice, ki tvorijo kostnino).
For practical information about using Movymia, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Movymia naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
Patients should receive calcium and vitamin D supplements if they do not get enough from their diet. Movymia can be used for up to two years.
Bolniki morajo jemati tudi dodatek kalcija in vitamina D, če ju ne dobivajo dovolj s prehrano.
Osteoporosis can also occur as a side effect of glucocorticoid treatment in men and women.
Osteoporoza lahko pri moških in ženskah nastane tudi kot neželeni učinek zdravljenja z glukokortikoidi.
The active substance in Movymia, teriparatide, is identical to part of the human parathyroid hormone.
Zdravilna učinkovina v zdravilu Movymia, teriparatid, je enaka delu humanega paratiroidnega hormona.
Movymia is a ‘biosimilar medicine'.
Zdravilo Movymia je „podobno biološko zdravilo“.
Further, Movymia and Forsteo produced similar effects on calcium levels in the blood.
Poleg tega sta imeli zdravili Movymia in Forsteo podoben učinek na raven kalcija v telesu.
For the full list of all side effects reported with Movymia, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Movymia, glejte navodilo za uporabo.
Movymia contains the active substance teriparatide.
Zdravilo Movymia vsebuje zdravilno učinkovino teriparatid.
The Agency's Committee for Medicinal Products for Human Use (CHMP) considered evidence showing that Movymia has a highly similar structure, purity and biological activity to Forsteo and is distributed in the body in the same way.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je obravnaval podatke, ki so dokazovali, da je zdravilo Movymia po zgradbi, čistosti in biološkem delovanju zelo podobno zdravilu
Laboratory studies comparing Movymia with Forsteo have shown that the active substance in Movymia is highly similar to that in Forsteo in terms of structure, purity and biological activity.
Laboratorijske študije, v katerih so zdravilo Movymia primerjali z zdravilom Forsteo, so pokazale, da je zdravilo Movymia po zgradbi, čistosti in biološkem delovanju zelo podobno zdravilu Forsteo.
How is Movymia used?
Kako se zdravilo Movymia uporablja?
How does Movymia work?
Kako zdravilo Movymia deluje?
Movymia is available as a solution for injection in cartridges (containing 600 micrograms of teriparatide) intended to be used with ServoPen Fix system.
Zdravilo Movymia je na voljo v obliki raztopine za injiciranje v vložkih (vsebujejo 600 mikrogramov teriparatida), namenjenih za uporabo s sistemom ServoPen Fix. Priporočeni odmerek je 20 mikrogramov zdravila Movymia, ki se daje enkrat dnevno z injiciranjem pod kožo v stegno ali trebuh.
The product information was amended accordingly.
Informacije o zdravilu so bile zato ustrezno spremenjene.
It was however acknowledged that in some patients a lower dose of 5mg could be effective.
Vendar so potrdili, da bi bil lahko pri nekaterih bolnikih učinkovit tudi manjši 5-miligramski odmerek.
Scientific conclusions and grounds for the variation to the terms of the marketing authorisations
Znanstveni zaključki in razlogi za spremembo pogojev dovoljenj za promet z zdravili
However, on a population level, the randomised trials only showed convincing evidence of efficacy of the 10mg dose of zolpidem.
Vendar so randomizirana preskušanja na ravni populacije pokazala prepričljive dokaze le o učinkovitosti 10-miligramskega odmerka zolpidema.
The currently recommended daily dose in the elderly and in patients with hepatic impairment is 5mg, and this dose recommendation remains unchanged in the product information.
Trenutno priporočeni dnevni odmerek pri starejših bolnikih ter bolnikih z jetrno okvaro je 5 mg in ostaja nespremenjen v informacijah o zdravilu.
The PRAC therefore agreed that the recommended daily dose of zolpidem should not be reduced for adults.
Odbor PRAC se je zato strinjal, da se priporočeni dnevni odmerek zolpidema pri odraslih ne bi smel zmanjšati.
Therefore in July 2013, AIFA requested the PRAC to give a recommendation under Article 31 of Directive 2001/83/EC on whether marketing authorisation of these products should be maintained, varied, suspended, or withdrawn.
Julija 2013 je zato agencija AIFA zaprosila odbor PRAC za priporočilo v skladu s členom 31 Direktive 2001/83/ES, ali naj se dovoljenje za promet s temi zdravili ohrani, spremeni, začasno umakne ali ukine.
Grounds for the PRAC recommendation
Podlaga za priporočilo odbora PRAC
Based on evidence from the literature, it was considered necessary to amend and harmonise the ‘Interaction with other medicinal products' section of the product information.
Na podlagi dokazov iz literature so menili, da je v informacijah o zdravilu treba spremeniti in uskladiti poglavje „Medsebojno delovanje z drugimi zdravili“.
• The PRAC considered the procedure under Article 31 of Directive 2001/83/EC resulting from pharmacovigilance data for zolpidem-containing medicinal products;
• odbor PRAC je obravnaval napotitev v skladu s členom 31 Direktive 2001/83/ES, ki je bila na podlagi farmakovigilančnih podatkov sprožena za zdravila, ki vsebujejo zolpidem;
• The PRAC also reviewed the available data on the efficacy of zolpidem in order to determine whether amendments to the posology would help to minimise the risks but agreed that the available efficacy data do not provide robust evidence that a lower dose would be effective on a population level;
• odbor PRAC je prav tako pregledal razpoložljive podatke o učinkovitosti zolpidema, da bi ugotovil, ali bi lahko spremembe odmerjanja pomagale zmanjšati ta tveganja, vendar je ugotovil, da razpoložljivi podatki o učinkovitosti ne vsebujejo trdnih dokazov, da bi bil lahko manjši odmerek učinkovit na ravni populacije;
Some studies showed an association between impaired driving performance on the next morning and middle of the night intake of zolpidem.
Nekatere študije so pokazale povezavo med poslabšano sposobnostjo vožnje naslednje jutro in zaužitjem zolpidema sredi noči.
It was therefore considered by the PRAC that the dosing recommendation should include instructions that Zolpidem is to be taken in a single intake immediately at bedtime and should not be re-administered during the same night.
Odbor PRAC je zato menil, da morajo priporočila za odmerjanje vključevati navodila, da se sme enkratni odmerek zolpidema zaužiti tik pred spanjem in se ne sme ponovno vzeti v isti noči.
Finally and in view of further minimising the risks of impaired driving and somnambulism, a potential lowering of the recommended dose for adults was discussed by the PRAC.
Na koncu je odbor PRAC zaradi dodatnega zmanjšanja tveganja poslabšane sposobnosti vožnje in somnambulizma razpravljal še o morebitnem zmanjšanju priporočenega odmerka za odrasle.
In February 2013, the Pharmacovigilance Risk Assessment Committee (PRAC) discussed the results of the search in EudraVigilance (EV) of cases of impaired driving ability as well as road traffic accidents associated with zolpidem, performed by the Italian Competent Authority (AIFA).
Februarja 2013 je Odbor za oceno tveganja na področju farmakovigilance (PRAC) razpravljal o rezultatih iskanja primerov poslabšane sposobnosti vožnje in prometnih nesreč, povezanih z zolpidemom, v zbirki EudraVigilance (EV), ki ga je izvedel italijanski pristojni organ (AIFA).
The CMDh, having considered the PRAC recommendation dated 6 March 2014 pursuant to Article 107k(1) and (2) of Directive 2001/83/EC, reached a position on the variation of the marketing authorisations of zolpidem containing medicinal products for which the amendments to the product information are set out in annex III.
Usklajevalna skupina CMDh je po proučitvi priporočila odbora PRAC z dne 6. marca 2014 v skladu s členom 107k(1) in (2) Direktive 2001/83/ES sprejela stališče glede spremembe dovoljenj za promet z zdravili, ki vsebujejo zolpidem, za katera so spremembe informacij o zdravilu navedene v Prilogi III.
The analysis of the submitted individual case reports of driving ability and somnambulism showed that whatever the age and gender category, most of the cases of impaired driving were reported at a 10mg daily dose for both events.
Analiza predloženih poročil o posameznih primerih poslabšane sposobnosti vožnje in somnambulizma je pokazala, da so o največ primerih poslabšane sposobnosti vožnje in somnambulizma poročali pri dnevnem odmerku 10 mg ne glede na starost in spol.
Considering that the effect of zolpidem may last for at least 8 hours and in view of the above referred risk factors, the PRAC also recommended to include warnings indicating that the risk of impaired driving is increased if zolpidem is taken within less than 8 hours before performing activities that require mental alertness, if zolpidem is taken in a higher than the recommended dose, and/or coadministered with other CNS depressants, and/or alcohol or illicit drugs.
Ker lahko učinek zolpidema traja vsaj 8 ur in zaradi zgoraj navedenih dejavnikov tveganja, je odbor PRAC prav tako priporočil vključitev opozoril, ki navajajo, da je tveganje poslabšane sposobnosti vožnje povečano, če se zolpidem zaužije manj kot 8 ur pred opravljanjem dejavnosti, ki zahtevajo umsko pozornost, če se vzame večji odmerek zolpidema od priporočenega in/ali če se vzame sočasno z drugimi zdravili, ki povzročajo depresijo osrednjega živčevja, in/ali alkoholom ali prepovedanimi drogami.
The PRAC, as a consequence, concluded that the benefit-risk balance of the medicinal products containing zolpidem identified in Annex I remains favourable, subject to the changes to the product information set out in Annex III.
je PRAC zaključil, da je razmerje med tveganji in koristmi zdravil, ki vsebujejo zolpidem in so navedena v Prilogi I, še naprej ugodno pod pogojem, da se upoštevajo spremembe informacij o zdravilu, navedene v Prilogi III.
Following this, the PRAC requested the MAH of the reference medicinal product for zolpidem to submit a cumulative review of spontaneous cases, clinical studies and published literature of ‘impaired driving ability', ‘Road traffic accidents' and ‘Somnambulism' associated with zolpidem.
Zatem je odbor PRAC od imetnika dovoljenja za promet z referenčnim zdravilom za zolpidem zahteval, naj predloži kumulativni pregled spontanih primerov, kliničnih študij in objavljene literature za „poslabšano sposobnost vožnje“, „prometne nesreče“ in „somnambulizem“, ki so povezani z zolpidemom.
With regards to the effects on the ability to drive and use machines, the PRAC recommended that vehicle drivers and machine operators are warned that in addition to the possible risk of drowsiness, prolonged reaction time and impaired driving the morning after therapy, there is also the possibility of dizziness, sleepiness, blurred/double vision and reduced alertness.
Glede učinkov na sposobnost vožnje in upravljanja strojev je odbor PRAC priporočil opozorilo za voznike in upravljavce strojev, da poleg morebitnega tveganja dremavosti, podaljšanega reakcijskega časa in poslabšane sposobnosti vožnje jutro po zdravljenju prav tako obstaja nevarnost omotice,
Based on the totality of the data available on the safety and the efficacy of zolpidem, and considering all the risk minimisation measures proposed during assessment, the PRAC concluded that the benefitrisk balance of zolpidem-containing medicinal products remains favourable subject to changes to the product information.
Na podlagi vseh razpoložljivih podatkov o varnosti in učinkovitosti zolpidema in ob upoštevanju vseh ukrepov za zmanjšanje tveganja, ki so bili predlagani med postopkom ocenjevanja, je odbor PRAC zaključil, da je razmerje med tveganji in koristmi zdravil, ki vsebujejo zolpidem, še naprej ugodno pod pogojem, da se upoštevajo spremembe informacij o zdravilu.
• The PRAC considered that the data from post-marketing spontaneous case reports, clinical trials, published literature and other available information have shown that the use of zolpidemcontaining products is associated with an increased risk of impaired driving and somnambulism;
• odbor PRAC je menil, da so podatki iz poročil o spontanih primerih iz obdobja trženja, kliničnih preskušanj, objavljene literature in drugi razpoložljivi podatki pokazali, da je uporaba zdravil, ki vsebujejo zolpidem, povezana s povečanim tveganjem poslabšane sposobnosti vožnje ter somnambulizma;
Amongst the risk factors for impaired driving and somnambulism were, concomitant intake of other CNS depressants, sleep-deprivation and alcohol or illicit drugs consumption.
Med dejavniki tveganja poslabšane sposobnosti vožnje in somnambulizma so bili sočasno jemanje drugih zdravil, ki povzročajo depresijo osrednjega živčevja, pomanjkanje spanja in uživanje alkohola ali prepovedanih drog.
The PRAC reviewed the safety and efficacy data relating to the risk of impaired driving and somnambulism following treatment with zolpidem.
Odbor PRAC je pregledal podatke o varnosti in učinkovitosti, povezane s tveganjem poslabšane sposobnosti vožnje in somnambulizma po zdravljenju z zolpidemom.
In light of the data provided in the cumulative review performed by the MAH, and taking into consideration the recent Food and Drug Administration (FDA) approved label changes specifying new dosing recommendations for zolpidem-containing medicinal products, AIFA considered that it was in the interest of the EU to refer the matter to the PRAC for a benefit-risk review of zolpidem-containing medicinal products.
Na podlagi podatkov iz kumulativnega pregleda, ki ga je opravil imetnik dovoljenja za promet, in nedavnih sprememb informacij o zdravilu glede novih priporočil za odmerjanje zdravil, ki vsebujejo zolpidem, ki jih je priporočila Uprava za hrano in zdravila (FDA), je italijanska agencija AIFA menila, da v interesu EU zadevo napoti na odbor PRAC, ki bo opravil presojo razmerja med tveganji in koristmi zdravil, ki vsebujejo zolpidem.
Discrepancies about drug-drug interactions information were observed in different product information of zolpidem containing products, notably on the interaction of zolpidem with CNS depressant.
V različnih informacijah o zdravilih, ki vsebujejo zolpidem, so opazili odstopanja pri informacijah o medsebojnem delovanju zdravil, predvsem pri medsebojnem delovanju zolpidema in zdravil, ki povzročajo depresijo osrednjega živčevja.
• The PRAC reviewed all available data provided by the MAHs on the safety and efficacy of zolpidemcontaining medicines with regards the risk of impaired driving ability and somnambulism following treatment with zolpidem;
• odbor PRAC je pregledal vse razpoložljive podatke o varnosti in učinkovitosti, ki so jih predložili imetniki dovoljenj za promet z zdravili, ki vsebujejo zolpidem, glede tveganja poslabšane sposobnosti vožnje in somnambulizma po zdravljenju z zolpidemom;
The provided data did not consistently show that a lower dose would be effective or that a lower dose would significantly reduce the risk of impaired driving and somnambulism, and it was considered that reducing the daily recommended dose would likely result in in-effective doses being used, in turn resulting in additional doses being taken in the middle of the night and in an increased risk of accidents the following day.
Menili so, da bi zmanjšanje dnevnega odmerka verjetno povzročilo neučinkovito odmerjanje in posledično jemanje dodatnih odmerkov sredi noči ter povečano tveganje prometnih nesreč naslednji dan.
The CMDh, having considered the PRAC recommendation dated 6 March 2014 with regards to zolpidem-containing medicinal products, agrees with the recommendation therein as stated below:
Usklajevalna skupina za postopek medsebojnega priznavanja in decentralizirani postopek, CMDh,se je po proučitvi priporočila, ki ga je za zdravila, ki vsebujejo zolpidem, 6. marca 2014 izdal odbor PRAC, strinjala s priporočilom, ki je navedeno v nadaljevanju:
• The PRAC considered that the above-mentioned risks of impaired driving ability and somnambulism could be mitigated by changes to the product information of zolpidem-containing medicines, in particular that zolpidem should be taken as a single intake immediately at bedtime and not exceed the recommended dose, without being re-administered during the same night, as well as highlighting the risks regarding impaired driving and somnambulism, warnings and precautions aimed at decreasing this risk and also the risks of co-administration with CNS depressants and alcohol, and/ or illicit drugs;
• odbor PRAC je menil, da se lahko zgoraj navedena tveganja poslabšane sposobnosti vožnje in somnambulizma zmanjšajo s spremembo informacij o zdravilih, ki vsebujejo zolpidem, in sicer je treba vnesti podatek, da je treba enkratni odmerek zolpidema zaužiti tik pred spanjem in da se priporočeni odmerek ne sme preseči ter ponovno vzeti v isti noči.
This will take about one hour.
To traja približno eno uro.
Date of first authorisation: 20 November 2018
Datum prve odobritve: 20. november 2018
EXP After reconstitution: use immediately.
EXP Po rekonstituciji: uporabite takoj.
Frequency not known (cannot be estimated from the available data):
neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov):
Uncommonly these can lead to severe allergic shock.
Občasno lahko povzročijo resen alergijski šok.
Do not drive or use machines if you have these symptoms.
Ne upravljajte vozil ali strojev, če imate te simptome.
Take the desired number of vials from the refrigerator.
Vzemite želeno število vial iz hladilnika.
Additional experience from clinical studies
Dodatne izkušnje iz kliničnih študij
Number of deaths, n (%)
Število smrti, n (%)
• regular blood tests to ensure it is safe for you to continue treatment
• opravljali bodo redne preiskave krvi za zagotovitev, da je za vas nadaljevanje zdravljenja varno;
• excessive water loss (dehydration)
• čezmerna izguba vode (dehidracija);
The use of gloves, goggles and protective clothing is recommended.
Priporočljiva je uporaba rokavic, zaščitnih očal in zaščitne obleke.
There is very little information available on whether the elimination of paclitaxel differs between races.
Na voljo je zelo malo informacij o tem, ali se izločanje paklitaksela razlikuje med rasami.