natgillin/translations-raw huggingface dataset:
The full EPAR for Osseor 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 Osseor je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Other information about Osseor
Druge informacije o zdravilu Osseor
Osseor should be taken at least two hours after food, milk, milk products or calcium supplements, preferably at bedtime.
Zdravilo Osseor je treba vzeti najmanj dve uri po zaužitju hrane, mleka, mlečnih izdelkov ali kalcijevih dodatkov, najbolje pred spanjem.
The company will also carry out a study to evaluate the effectiveness of the measures that have been put in place to reduce risk of heart and circulatory problems.
Družba bo izvedla tudi študijo, v kateri bo ocenjevala učinkovitost vzpostavljenih ukrepov za zmanjšanje tveganja za nastanek težav s srcem in obtočili.
What benefit has Osseor shown during the studies?
Kakšne koristi je zdravilo Osseor izkazalo med študijami?
These materials will also remind doctors of the approved used of the medicine.
Poleg tega bo gradivo zdravnikom služilo kot opomnik o odobrenih načinih uporabe zdravila.
The study looked at changes in the bone density after one year of treatment.
V študiji so proučevali spremembe gostote kosti po enoletnem zdravljenju.
A risk management plan has been developed to ensure that Osseor is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Osseor je bil pripravljen načrt obvladovanja tveganj.
Treatment should only be started by a doctor with experience of treating osteoporosis.
Zdravljenje lahko uvede le zdravnik, ki ima izkušnje z zdravljenjem osteoporoze.
For more information about treatment with Osseor, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Osseor preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
This is a summary of the European public assessment report (EPAR) for Osseor.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Osseor.
The most common side effects with Osseor (which may affect more than 1 in 10 people) are hypersensitivity (allergic) skin reactions (rash, itching, urticaria or itchy rash, and swelling beneath the skin known as angioedema) and pain affecting muscles, bones and joints.
Najpogostejši neželeni učinki zdravila Osseor (ki lahko prizadenejo več kot 1 osebo od 10) so preobčutljivostne (alergijske) kožne reakcije (izpuščaji, srbenje, urtikarija ali srbeči izpuščaji in otekanje pod kožo, znano kot angioedem) ter bolečine, ki prizadenejo mišice, kosti in sklepe.
In order to reduce the risk of heart attack, Osseor must also not be used in patients with high blood pressure that is not properly controlled or in patients with a current or past history of any of the following:
Za zmanjšanje tveganja za srčni napad zdravila Osseor ne smejo jemati bolniki z visokim krvnim tlakom, ki ni ustrezno nadzorovan, ali bolniki, ki trenutno imajo ali so v preteklosti imeli katerega koli od naslednjih obolenj:
The CHMP decided that Osseor's benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Osseor večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
What is the risk associated with Osseor?
Kakšna tveganja so povezana z zdravilom Osseor?
The contents of the sachet are added and mixed into a glass of water to form a suspension, which is drunk just after being prepared.
Vsebina vrečke se v kozarcu vode zmeša v suspenzijo, ki jo je treba popiti takoj po pripravi.
• ischaemic heart disease (such as angina or a heart attack);
• ishemično obolenje srca (kot je angina pektoris ali srčni napad);
Overall, the results of the second study taken alone were insufficient to demonstrate a benefit of Osseor in preventing bone breaks.
Gledano v celoti, pa rezultati druge študije niso zadostno dokazali koristi zdravila Osseor pri preprečevanju zlomov kosti.
This showed that the risk of broken bones is reduced.
To je dokaz, da se je tveganje za pojav zloma zmanjšalo.
Osseor is taken as one sachet once a day.
Zdravilo Osseor se jemlje v odmerku ene vrečke enkrat na dan.
Osseor is used to treat severe osteoporosis (a disease that makes bones fragile) in post-menopausal women and men who have a high risk of fracture and cannot be treated with other medicines approved for osteoporosis.
Zdravilo Osseor se uporablja za zdravljenje hude osteoporoze (bolezni, ki povzroča krhkost kosti) pri ženskah po menopavzi in moških, pri katerih obstaja veliko tveganje za zlom kosti in ki jih ni mogoče zdraviti z drugimi zdravili, odobrenimi za osteoporozo.
It must not be used in people who are temporarily or permanently immobilised, such as people on bed rest or recovering from surgery.
Prav tako ga ne smejo uporabljati osebe, ki se začasno ali trajno ne morejo gibati, kot so npr. osebe z odrejenim mirovanjem v postelji ali bolniki po operaciji.
As there has been some data showing an increased risk of heart attack with Osseor, the decision to prescribe Osseor should take into account the patient's individual heart risk.
Ker nekateri podatki kažejo na povečano tveganje za srčni napad v povezavi z zdravilom Osseor, je treba pri predpisovanju zdravila upoštevati posameznikovo tveganje za srčni napad.
• peripheral arterial disease (obstruction of the blood flow in the arteries, usually in the legs);
• periferno arterijsko obolenje (motnje pretoka krvi po arterijah, običajno v nogah);
Osseor must not be used in patients who have or have had venous thromboembolic events (problems due to the formation of blood clots in the veins, such as in the legs or lungs).
Zdravila ne smejo uporabljati bolniki, ki imajo ali so imeli vensko trombembolijo (težave zaradi nastajanja krvnih strdkov v venah, na primer v nogah ali pljučih).
The first study included 1,649 women with osteoporosis who had already had a broken bone in the spine and the second included over 5,000 women whose osteoporosis was affecting the hip.
V prvo študijo je bilo vključenih 1 649 žensk z osteoporozo, ki so že imele zlomljeno kost v hrbtenici, v drugo študijo pa prek 5 000 žensk z osteoporozo, ki je prizadela kolke.
It is available as 2 g sachets containing granules that are made up into an oral (by mouth) suspension.
Na voljo je v 2-gramskih vrečkah, ki vsebujejo zrnca za pripravo peroralne raztopine (ki se zaužije skozi usta).
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Osseor.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Osseor, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila Osseor in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
Osseor has been studied in almost 7,000 elderly women in two large studies.
Zdravilo Osseor so proučevali v dveh obsežnih študijah, ki sta vključevali skoraj 7 000 starejših žensk.
Osseor is a medicine that contains the active substance strontium ranelate.
Osseor je zdravilo, ki vsebuje zdravilno učinkovino stroncijev ranelat.
Exactly how strontium works in osteoporosis is not fully understood, but it is known to stimulate bone formation and reduce bone breakdown.
Delovanje stroncija pri osteoporozi ni v celoti pojasnjeno, je pa znano, da spodbuja tvorjenje kosti in zmanjšuje njihovo razgradnjo.
Why has Osseor been approved?
Zakaj je bilo zdravilo Osseor odobreno?
In addition, education materials are sent to patients and healthcare professionals prescribing Osseor reminding them of the risk of heart and circulatory problems with the medicine and of the need for regular monitoring.
Poleg tega bodo bolniki in zdravniki, ki bodo predpisovali zdravilo Osseor, prejeli izobraževalno gradivo z opozorilom, da obstaja pri jemanju zdravila tveganje za nastanek težav s srcem in obtočili ter da je treba bolnike redno spremljati.
However, when looking only at women of 74 years of age or older with particularly weak thighbones, the results suggested a reduction of the risk of breaks in the hip with Osseor.
Kljub temu so rezultati, dobljeni pri ženskah, starih 74 let ali več, ki so imele posebno šibki stegnenici, pokazali, da je zdravilo Osseor zmanjšalo tveganje za zlom kolka.
Osseor has also been compared with placebo in a main study involving 261 male patients at increased risk of having a broken bone.
Zdravilo Osseor so s placebom primerjali tudi v glavni študiji, ki je vključevala 261 bolnikov s povečanim tveganjem za zlom kosti.
When looking at results of the two studies taken together, fewer women in the Osseor group developed breaks at any site outside the spine (including the hip) than in the placebo group (331 out of 3,295 with Osseor compared with 389 out of 3,256 for placebo).
Na podlagi rezultatov obeh študij skupaj je mogoče ugotoviti, da je do zlomov kosti na katerem koli predelu okostja razen hrbtenice (vključno s kolkom) prišlo pri manj ženskah iz skupine, ki je jemala zdravilo Osseor, kot pri tistih iz skupine, ki je jemala placebo (331 izmed 3 295 v skupini, ki je jemala zdravilo Osseor, v primerjavi s 389 od 3 256 v skupini, ki je jemala placebo).
In the first study, this was based on the number of patients who, over three years, developed a new break in the spine, and in the second study, it was based on the number of patients who had a new break due to osteoporosis at any site other than the spine.
V prvi študiji je bilo tako za osnovo vzeto število bolnic, pri katerih je v triletnem obdobju prišlo do novega zloma v hrbtenici, v drugi študiji pa število bolnic, pri katerih je prišlo do novega zloma zaradi osteoporoze v katerem koli drugem predelu okostja razen v hrbtenici.
In the first study, Osseor reduced the risk of new breaks in the spine by 41% over three years: 21% of the 719 women who took Osseor developed a new break in the spine, compared with 33% of the 723 who took placebo.
V prvi študiji je zdravilo Osseor v triletnem obdobju za 41 % zmanjšalo tveganje za nove zlome v hrbtenici: do novega zloma kosti v hrbtenici je prišlo pri 21 % od 719 žensk, ki so jemale zdravilo Osseor, v primerjavi s 33 % od 723 žensk, ki so jemale placebo.
EPAR summary for the public strontium ranelate
Povzetek EPAR za javnost
In both studies, Osseor was compared with placebo (a dummy treatment) and the main measure of effectiveness was the reduction in the risk of a new bone break with Osseor.
V obeh študijah so učinke zdravila Osseor primerjali z učinki placeba (zdravila brez zdravilne učinkovine), glavno merilo učinkovitosti pa je bilo zmanjšanje tveganja za nove zlome ob jemanju zdravila.
• cerebrovascular disease (diseases affecting the blood vessels in the brain, such as stroke).
• cerebrovaskularno obolenje (obolenja, ki prizadenejo krvne žile v možganih, kot je možganska kap).
In the study in male patients, the bone density in the lower part of the spine increased by 7% after one year of treatment in patients taking Osseor, compared with an increase of 1.7% in patients taking placebo.
V študiji, ki je vključevala moške bolnike se je po enem letu zdravljenja gostota kosti v spodnjem delu hrbtenice pri tistih, ki so jemali zdravilo Osseor, povečala za 7 %, medtem ko se je pri bolnikih, ki so jemali placebo, povečala za 1,7 %.
In postmenopausal women, Osseor reduces the risk of vertebral and hip fractures.
Pri ženskah po menopavzi zdravilo zmanjša tveganje za zlom kosti v hrbtenici in kolkih.
Once in the gut, strontium ranelate releases strontium, which is absorbed into the bone.
Ko stroncijev ranelat prispe v črevesje, začne sproščati stroncij, ki se absorbira v kosti.
For the full list of all side effects reported with Osseor, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Osseor, glejte navodilo za uporabo.
What is Osseor used for?
Za kaj se zdravilo Osseor uporablja?
The active substance in Osseor, strontium ranelate, acts on the bone structure.
Zdravilna učinkovina v zdravilu Osseor, stroncijev ranelat, učinkuje na zgradbo kosti.
Osteoporosis is also observed in men due to gradual bone loss with ageing.
S staranjem se osteoporoza zaradi postopne izgube kostne mase pojavi tudi pri moških.
How has Osseor been studied?
Kako je bilo zdravilo Osseor raziskano?
What is Osseor?
Kaj je zdravilo Osseor?
How does Osseor work?
Kako zdravilo Osseor deluje?
How is Osseor used?
Kako se zdravilo Osseor uporablja?
Active substance + Strength
Zdravilna učinkovina + jakost
Marketing Authorisation Holder Short name of the Medicinal Product
Kratko ime zdravila
Germany Symbiopharm Gmbh
Nemčija Symbiopharm Gmbh
Austria Symbiopharm Gmbh
Avstrija Symbiopharm Gmbh
Hungary Symbiopharm Gmbh
Madžarska Symbiopharm Gmbh
More information on these medicines can be found on EMA's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Več informacij o teh zdravilih je na voljo na spletni strani agencije EMA: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The review of direct-acting antivirals for the treatment of hepatitis C was initiated on 17 March 2016 at the request of the European Commission, under Article 20 of Regulation (EC) No 726/2004.
Pregled neposredno delujočih protivirusnih zdravil se je pričel 17. marca 2016 na zahtevo Evropske komisije v skladu s členom 20 Uredbe (ES) št. 726/2004.
You may also receive treatment for hepatitis B.
Morda boste zdravljeni tudi za hepatitis B.
Speak to your doctor if you have any question or concern regarding your treatment.
Če imate kakršna koli vprašanja ali pomisleke v zvezi z zdravljenjem, se posvetujte z zdravnikom.
2 Around 30 cases of hepatitis B re-activation have been reported to date among the many thousands of patients treated.
2 Do zdaj so poročali o približno 30 primerih reaktivacije hepatitisa B med več tisoč zdravljenimi bolniki.
The CHMP's opinion was passed to the European Commission, which issued a legally binding decision valid throughout the EU.
Mnenje odbora CHMP je bilo posredovano Evropski komisiji, ki je izdala pravno zavezujoč sklep, veljaven v vsej EU.
The CHMP opinion was forwarded to the European Commission, which issued a final legally binding decision applicable in all EU Member States on 23/2/2017.
Mnenje odbora CHMP je bilo predloženo Evropski komisiji, ki je 23. februarja 2017 izdala končni pravno zavezujoč sklep, ki velja za vse države članice EU.
On 14 April 2016 the scope of the review was extended to include the risk of liver cancer, in addition to the potential risk of hepatitis B re-activation.
Obseg pregleda je bil 14. aprila 2016 razširjen tako, da je poleg morebitnega tveganja reaktivacije hepatitisa B vključeval tveganje raka jeter.
Direct-acting antivirals work by blocking the action of proteins which are essential for making new hepatitis C viruses.
Neposredno delujoča protivirusna zdravila delujejo tako, da zavirajo delovanje beljakovin, ki so nujne za nastanek novih virusov hepatitisa C.
• Therapeutic guidelines recommend that, in patients with advanced fibrosis and cirrhosis, surveillance for hepatocellular carcinoma should continue even after sustained viral response has been achieved.
• V terapevtskih smernicah je priporočeno, da je treba bolnike z napredovalima fibrozo in cirozo nadzorovati glede hepatocelularnega karcinoma tudi po tem, ko je dosežen trajni virološki odziv.
The PRAC recommendation to include a warning in the prescribing information about hepatitis B reactivation and how to minimise it was endorsed by EMA's Committee for Medicinal Products for Human Use (CHMP).
Priporočilo odbora PRAC o vključitvi opozorila o reaktivaciji hepatitisa B v podatke o predpisovanju zdravila in o tem, kako jo kar najbolj zajeziti, je podprl Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji.
Companies marketing these medicines have been asked to perform a prospective study to assess the risk of recurrence of previously treated hepatocellular carcinoma, and a prospective cohort study in patients with cirrhosis to assess the incidence and type of de novo hepatocellular carcinoma.
Podjetja, ki ta zdravila tržijo, so bila zaprošena, da izvedejo prospektivno študijo za oceno tveganja ponovitve predhodno zdravljenega hepatocelularnega karcinoma ter prospektivno kohortno študijo pri bolnikih s cirozo za oceno pojavnosti in vrste hepatocelularnega karcinoma de novo.
Further studies needed to assess risk of liver cancer with these medicines
Za oceno tveganja raka jeter pri teh zdravilih so potrebne nadaljnje študije
The CHMP agreed that companies should carry out a study to evaluate the risk of liver cancer returning with direct-acting antivirals.
Odbor CHMP je soglašal, da morajo podjetja izvesti študijo, v kateri bodo ocenila tveganje za ponovitev raka jeter pri uporabi neposredno delujočih protivirusnih zdravil.
The review was carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), the committee responsible for the evaluation of safety issues for human medicines, which made a set of recommendations.
Pregled je opravil Odbor za oceno tveganja na področju farmakovigilance (PRAC), ki je odgovoren za presojo varnostnih vprašanj o zdravilih za uporabo v humani medicini, in podal več priporočil.
In addition to data on hepatitis B re-activation, EMA also reviewed data suggesting that patients treated with direct-acting antivirals who have previously been treated for liver cancer could be at risk of their cancer returning early.
Poleg podatkov o reaktivaciji hepatitisa B je agencija EMA pregledala tudi podatke, ki kažejo, da pri bolnikih, zdravljenih z neposredno delujočimi protivirusnimi zdravili, ki so bili predhodno zdravljeni zaradi raka jeter, obstaja tveganje zgodnje ponovitve raka.
These measures aim to minimise the risk of hepatitis B re-activation with direct-acting antivirals.
Ti ukrepi so namenjeni zmanjševanju tveganja reaktivacije hepatitisa B pri neposredno delujočih protivirusnih zdravilih.
The review of direct-acting antivirals was carried out by EMA's Pharmacovigilance Risk Assessment Committee (PRAC).
Pregled neposredno delujočih protivirusnih zdravil je izvedel Odbor za oceno tveganja na področju farmakovigilance (PRAC) pri Evropski agenciji za zdravila.
On 15 December 2016, the European Medicines Agency (EMA) confirmed its recommendation to screen all patients for hepatitis B before starting treatment with direct-acting antivirals for hepatitis C; patients infected with both hepatitis B and C viruses must be monitored and managed according to current clinical guidelines.
Evropska agencija za zdravila (EMA) je 15. decembra 2016 potrdila, da pred začetkom zdravljenja z neposredno delujočimi protivirusnimi zdravili za hepatitis C priporoča presejalno testiranje vseh bolnikov za hepatitis B. Bolnike, ki so okuženi z virusoma hepatitisa B in C, je treba spremljati in obravnavati v skladu s trenutnimi kliničnimi smernicami.
• Direct-acting antiviral medicines (including Daklinza, Exviera, Harvoni, Olysio, Sovaldi and Viekirax) are effective treatments for long-term hepatitis C that can be used without interferons (medicines known to have troublesome side effects).
• Neposredno delujoča protivirusna zdravila (vključno z zdravili Daklinza, Exviera, Harvoni, Olysio, Sovaldi in Viekirax) predstavljajo učinkovito zdravljenje za dolgotrajni hepatitis C, ki ga je mogoče izvajati brez interferonov (zdravil, za katera je znano, da imajo problematične neželene učinke).
Direct-acting antivirals (marketed in the EU as Daklinza, Exviera, Harvoni, Olysio, Sovaldi and Viekirax)1 are important medicines for treating chronic (long term) hepatitis C, a disease of the liver caused by hepatitis C virus.
Neposredno delujoča protivirusna zdravila (ki se v EU tržijo pod imeni Daklinza, Exviera, Harvoni, Olysio, Sovaldi in Viekirax)1 so pomembna zdravila za zdravljenje kroničnega (dolgotrajnega) hepatitisa C, bolezni jeter, ki jo povzroča virus hepatitisa C.
The review covered the following direct-acting antivirals for treating chronic hepatitis C: Daklinza (daclatasvir), Exviera (dasabuvir), Harvoni (sofosbuvir / ledipasvir), Olysio (simeprevir), Sovaldi
Pregled je zajemal naslednja neposredno delujoča protivirusna zdravila za zdravljenje kroničnega hepatitisa C: Daklinza (daclatasvir), Exviera (dasabuvir), Harvoni (sofosbuvir/ledipasvir), Olysio (simeprevir), Sovaldi (sofosbuvir) in Viekirax (ombitasvir/paritaprevir/ritonavir).
• If you have both hepatitis B and C virus infections, your doctor will monitor you closely during and after treatment with direct-acting antivirals.
• Če ste okuženi z virusoma hepatitisa B in C, vas bo zdravnik med zdravljenjem z neposredno delujočimi protivirusnimi zdravili in po njem skrbno spremljal.
In this context, further research is also needed on the risk of new liver cancers in patients with chronic hepatitis C and cirrhosis (liver scarring) that are treated with directacting antivirals.
nadaljnje raziskave o tveganju novih rakov jeter pri bolnikih s kroničnim hepatitisom C in cirozo (brazgotinjenjem jeter), ki so zdravljeni z neposredno delujočimi protivirusnimi zdravili.
• Further studies are needed to evaluate the risk of recurring or newly diagnosed hepatocellular carcinoma in patients treated with direct-acting antivirals.
• Za oceno tveganja ponovitve ali nastanka na novo diagnosticiranega hepatocelularnega karcinoma pri bolnikih, zdravljenih z neposredno delujočimi protivirusnimi zdravili, so potrebne nadaljnje študije.
• You will be tested for hepatitis B before starting treatment with direct-acting antivirals to check if you might be at risk of hepatitis B reactivation.
• Pred začetkom zdravljenja z neposredno delujočimi protivirusnimi zdravili boste poslani na preiskave za hepatitis B, da se preveri, ali pri vas obstaja tveganje reaktivacije hepatitisa B.
• All patients should be screened for hepatitis B before starting treatment with direct-acting antivirals for hepatitis C; patients co-infected with hepatitis B and C must then be monitored and managed according to current clinical guidelines.
• Pred začetkom zdravljenja z neposredno delujočimi protivirusnimi zdravili za hepatitis C je treba vse bolnike presejalno testirati za hepatitis B. Bolnike, ki so sočasno okuženi z virusoma hepatitisa B in C, je treba nato spremljati in obravnavati v skladu s trenutnimi kliničnimi smernicami.
• If you also have hepatitis B virus infection, direct-acting antivirals for hepatitis C may cause the hepatitis B infection to become active again.
• Če ste okuženi tudi s hepatitisom B, lahko neposredno delujoča protivirusna zdravila ponovno aktivirajo okužbo s hepatitisom B. Reaktivacija hepatitisa B lahko povzroči hude težave z jetri.
It looked into cases2 of returning signs and symptoms of previously inactive hepatitis B infection (re-activation) when patients were treated with direct-acting antivirals for hepatitis C.
Pregledal je primere2, pri katerih so se med zdravljenjem bolnikov z neposredno delujočimi protivirusnimi zdravili za hepatitis C vrnili znaki in simptomi prej neaktivne okužbe s hepatitisom B (primere reaktivacije).
• Tell your doctor if you have or have had hepatitis B infection.
• Če ste ali ste bili okuženi z virusom hepatitisa B, to povejte zdravniku.
1 Since the start of this review, two other direct-acting antivirals, Epclusa (sofosbuvir / velpatasvir) and Zepatier (elbasvir / grazoprevir), have been authorised in the EU.
1 Dovoljenje za promet v EU sta po začetku tega pregleda dobili dve drugi neposredno delujoči protivirusni zdravili, zdravilo Epclusa (sofosbuvir/velpatasvir) in zdravilo Zepatier (elbasvir/grazoprevir).