natgillin/translations-raw huggingface dataset:
On 21 June 2012, the European Medicines Agency completed a review of the safety and effectiveness of tolperisone.
Evropska agencija za zdravila je 21. junija 2012 opravila pregled varnosti in učinkovitosti tolperizona.
After re-examination, the Committee confirmed these recommendations on 18 October 2012.
CHMP je po ponovnem pregledu 18. oktobra 2012 ta priporočila potrdil.
Medicines containing tolperisone are available as tablets and/or solution for injection in Bulgaria, Cyprus, Czech Republic, Germany, Hungary, Latvia, Lithuania, Poland, Romania and Slovakia, under various trade names.
Zdravila, ki vsebujejo tolperizon, so na voljo v obliki tablet in/ali raztopine za injiciranje v Bolgariji, na Cipru, Češkem, v Nemčiji, na Madžarskem, v Latviji, Litvi, na Poljskem, v Romuniji in na Slovaškem pod različnimi tržnimi imeni.
If symptoms of hypersensitivity occur, treatment should be stopped immediately.
Če se pojavijo preobčutljivostni simptomi, je treba zdravljenje nemudoma prekiniti.
What is tolperisone?
Kaj je tolperizon?
In Germany, several indications approved in other countries were not authorised because the German medicines agency considered that tolperisone's effectiveness had not been proven in those indications.
Nemčiji nekatere indikacije, ki so odobrene v drugih državah, niso bile sprejete, saj je nemška agencija za zdravila presodila, da učinkovitost tolperizona za te indikacije ni bila dokazana.
As tolperisone-containing medicines have been developed by different companies and have been authorised through national procedures in the EU Member States, they are used to treat different conditions in different countries.
Ker so zdravila, ki vsebujejo tolperizon, razvila različna podjetja in so bila odobrena v nacionalnih postopkih v državah članicah EU, se v različnih državah uporabljajo za zdravljenje različnih obolenj.
The Committee also reviewed the available postmarketing data on spontaneous reports of side effects.
Odbor je pregledal tudi razpoložljive podatke iz obdobja trženja o spontanih poročilih v zvezi s stranskimi učinki.
On 15 July 2011, it asked the CHMP to issue an opinion on whether the marketing authorisations for tolperisone-containing products should be maintained, varied, suspended or withdrawn across the EU.
15. julija 2011 je zaprosila odbor CHMP, naj izda mnenje o tem, ali je treba dovoljenja za promet z zdravili, ki vsebujejo tolperizon, v celotni EU ohraniti, spremeniti, začasno umakniti ali preklicati.
What are the conclusions of the CHMP?
Kakšni so zaključki Odbora CHMP?
However, the study only included adults with post-stroke spasticity.
Vendar pa je študija vključevala le odrasle s spastičnostjo po možganski kapi.
The CHMP noted that most of the studies with oral tolperisone, performed in the 1960s and 1970s, were of a lower standard than that expected today.
Odbor CHMP je opozoril, da je večina študij, ki so bile opravljene s peroralnim tolperizonom v 60. in 70. letih prejšnjega stoletja, nižjega standarda, kot je zahtevan v današnjem času.
Tolperisone is a muscle relaxant.
Tolperizon je mišični relaksant.
The CHMP confirmed the above conclusions after re-examining its opinion.
Odbor CHMP je po ponovnem pregledu svojega mnenja potrdil gornje sklepe.
The Committee therefore recommended that the product information should be updated to reflect this risk and include a warning on the signs of hypersensitivity.
Odbor je zato priporočil posodobitev podatkov o zdravilu tako, da bodo odražali to tveganje in vključevali opozorilo o znakih preobčutljivosti.
• Patients should note that symptoms of hypersensitivity can include flushing, rash, severe itching of the skin (with raised lumps), wheezing, difficulty breathing, difficulty in swallowing, fast heartbeat, low blood pressure and fast decrease in blood pressure.
• Bolniki naj se zavedajo, da lahko preobčutljivostni simptomi vključujejo vročinske oblive, izpuščaj, hudo srbečico kože (z dvignjenimi bulicami), sopenje, oteženo dihanje, oteženo požiranje, hiter srčni utrip, nizek krvni tlak in hiter padec krvnega tlaka.
Why were tolperisone-containing medicines reviewed?
Zakaj je bil za zdravila, ki vsebujejo tolperizon, opravljen pregled?
Tolperisone-containing medicines have been authorised in several countries in the EU since the 1960s for the treatment of muscle spasms (involuntary contractions) and spasticity caused by different conditions.
Zdravila, ki vsebujejo tolperizon, so v EU odobrena že od 60. let prejšnjega stoletja za zdravljenje mišičnih spazmov (nehotenih krčev) in spastičnosti, ki jo povzročajo različna obolenja.
The available data to support the use of tolperisone-containing medicines in locomotor diseases, vascular diseases, rehabilitation following surgery and Little's disease are limited and not convincing.
Razpoložljivi podatki, ki bi podprli uporabo zdravil, ki vsebujejo tolperizon, pri obolenjih lokomotornega sistema, žilnih boleznih, rehabilitaciji po kirurškem posegu in Littlovi bolezni, so omejeni in niso prepričljivi.
• Patients currently using tolperisone for any other indication or using injectable tolperisone should speak to their doctor at their next routine appointment so they can switch to an appropriate alternative treatment.
• Bolniki, ki trenutno uporabljajo tolperizon za katero koli drugo indikacijo ali ki uporabljajo tolperizon za injiciranje, naj se posvetujejo s svojim zdravnikom ob naslednjem načrtovanem pregledu, da bodo lahko prešli na ustrezno alternativno zdravljenje.
Only in the treatment of spasticity caused by neurological diseases was a study considered to be of acceptable quality, showing a moderate improvement of 32% in spasticity with oral tolperisone, compared with a 14% improvement in the placebo (a dummy treatment) group.
Le za študijo zdravljenja spastičnosti, povzročene z nevrološkimi obolenji, so menili, da je sprejemljive kakovosti, saj je prikazala zmerno izboljšanje za 32 % pri spastičnosti v skupini s peroralnim tolperizonom v primerjavi s 14 % izboljšanjem v skupini s placebom (zdravilom brez zdravilne učinkovine).
The CHMP reviewed data on the effectiveness of oral and injectable tolperisone in the different indications, including data from published clinical studies and analyses of various studies provided by the companies that market these medicines.
Odbor CHMP je pregledal podatke o učinkovitosti tolperizona, ki se daje peroralno in ki se injicira, za različne indikacije, vključno s podatki iz objavljenih kliničnih študij in analiz različnih študij, ki so jih posredovala podjetja, ki ta zdravila tržijo.
These include neurological diseases (related to the brain or nerves, such as multiple sclerosis), locomotor diseases (related to the spine and large joints such as the hip), vascular diseases (related to the blood vessels), rehabilitation following surgery, and Little's disease (also known as cerebral palsy, a rare disease where there is damage to parts of the brain that control movement).
Ta vključujejo nevrološke bolezni (povezane z možgani ali živci, kakršna je npr. multipla skleroza), obolenja lokomotornega sistema (povezana s hrbtenico in velikimi sklepi, kot je kolk), vaskularne bolezni (povezane s krvnimi žilami), rehabilitacijo po kirurškem posegu in Littlovo bolezen (znano tudi kot možganska paraliza - redka bolezen, pri kateri so poškodovani deli možganov, ki nadzirajo gibanje).
The Committee also recommended that the marketing authorisations for tolperisonecontaining medicines given by injection should be revoked throughout the European Union (EU).
Odbor je prav tako priporočil, naj se dovoljenja za promet z zdravili, ki vsebujejo tolperizon in se jih daje z injiciranjem, v vsej Evropski uniji (EU) prekliče.
Consequently, the German medicines agency considered that a full assessment of the benefit-risk balance of tolperisone should be carried out in all approved indications.
Posledično je nemška agencija za zdravila odločila, da je treba opraviti popolno oceno razmerja med tveganji in koristmi tolperizona za vse odobrene indikacije.
• Prescribers are advised that injectable tolperisone should no longer be used in the EU.
• Zdravnike je treba obvestiti, da tolperizona za injiciranje v EU ne smejo več uporabljati.
Doctors should stop prescribing tolperisone for any other indication.
Zdravniki naj prenehajo predpisovati tolperizon za druge indikacije.
Regarding the safety of tolperisone, the CHMP noted that more than half of the spontaneous reports of side effects with tolperisone were hypersensitivity reactions, while only a small number of hypersensitivity reports had been observed during the clinical trials that supported tolperisone's marketing authorisation.
V zvezi z varnostjo tolperizona je odbor CHMP opozoril, da je bila več kot polovica spontanih poročil o stranskih učinkih s tolperizonom preobčutljivostnih reakcij, medtem ko so opazili le manjše število poročil o preobčutljivosti med kliničnimi preskušanji, ki so podprla dovoljenje za promet z zdravili, ki vsebujejo tolperizon.
The exact way tolperisone works is not known, but it is thought to act in the brain and spinal cord to reduce the nerve impulses that make the muscles contract and become rigid.
Natančen mehanizem delovanja tolperizona ni povsem znan, predvidevajo pa, da s svojim delovanjem v možganih in hrbtenjači onemogoča živčne impulze, zaradi katerih se mišice krčijo in postanejo toge.
In addition, numerous reports of hypersensitivity (allergic) reactions to tolperisone had been reported post marketing in Germany.
Poleg tega so v Nemčiji v obdobju trženja prejeli številna poročila o preobčutljivostnih (alergijskih) reakcijah na tolperizon.
By reducing these impulses, tolperisone is believed to reduce muscle contraction, helping to relieve the stiffness.
Z onemogočanjem teh impulzov naj bi tolperizon onemogočil krčenje mišic in s tem olajšal togost.
In addition, since extremely limited data are available to support the safety and dosing recommendations of injectable tolperisone, the CHMP concluded that the benefits of this formulation do not outweigh the identified risks, and that the marketing authorisations for tolperisone-containing medicines given by injection should be revoked.
Poleg tega je zaradi dejstva, da so v podporo varnosti in priporočilom za odmerjanje tolperizona za injiciranje na voljo le izjemno omejeni podatki, je odbor CHMP zaključil, da koristi te oblike niso večje od ugotovljenih tveganj in da je treba dovoljenja za promet z zdravili za injiciranje, ki vsebujejo tolperizon, preklicati.
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of tolperisone-containing medicines given orally (by mouth) continue to outweigh their risks, but that their use should be restricted to the treatment of adults with post-stroke spasticity (stiffness).
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da so koristi peroralnih zdravil (zdravil, ki jih bolniki zaužijejo), ki vsebujejo tolperizon, še vedno večje od z njimi povezanih tveganj, vendar pa je treba njihovo uporabo omejiti na zdravljenje odraslih s spastičnostjo (togostjo)po možganski kapi.
• Patients should be informed of the possibility of hypersensitivity reactions during treatment with tolperisone.
• Bolnike je treba obvestiti, da med zdravljenjem s tolperizonom obstaja možnost za preobčutljivostne reakcije.
Therefore, based on the evaluation of the currently available data and considering that the risk of hypersensitivity reactions is more significant than previously identified, the CHMP concluded that the benefits of oral tolperisone-containing medicines continue to outweigh its risks only when used in the treatment of post-stroke spasticity in adults.
Zato je odbor CHMP na podlagi ocene trenutno razpoložljivih podatkov in ob upoštevanju, da je tveganje za preobčutljivostne reakcije bistveno večje od tveganja, ugotovljenega v preteklosti, zaključil, da so koristi peroralnih zdravil, ki vsebujejo tolperizon, še vedno večje od z njimi povezanih tveganj, vendar le pri uporabi za zdravljenje odraslih s spastičnostjo po možganski kapi.
• Patients should be aware that the benefits of oral tolperisone continue to outweigh its risks only for the treatment of post-stroke spasticity in adults.
• Bolniki se morajo zavedati, da so koristi peroralnega tolperizona še vedno večje od z njim povezanih tveganj le pri zdravljenju odraslih s spastičnostjo po možganski kapi.
• Prescribers are advised that the indication for oral tolperisone has been restricted to the treatment of post-stroke spasticity in adults.
• Zdravnike je treba obvestiti, da je bila indikacija za peroralni tolperizon omejena na zdravljenje spastičnosti po možganski kapi pri odraslih.
Patients should stop taking tolperisone and inform their doctor if they experience any of these symptoms.
Če bolniki zaznajo katerega koli od teh simptomov, naj nemudoma prenehajo jemati tolperizon in obvestijo svojega zdravnika.
This overview was last updated in 02-2019.
Povzetek je bil nazadnje posodobljen 02-2019.
Every year, the European Medicines Agency will review any new information that becomes available and this overview will be updated as necessary.
Evropska agencija za zdravila bo vsako leto ponovno pregledala vse nove podatke, ki bodo na voljo, in po potrebi posodobila ta povzetek.
Regarding safety, side effects occur frequently but are generally not serious and are manageable with appropriate treatment.
Kar zadeva varnost, se neželeni učinki pojavljajo pogosto, vendar običajno niso hudi in so z ustreznim zdravljenjem obvladljivi.
What measures are being taken to ensure the safe and effective use of Rubraca?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Rubraca?
Further information on Rubraca can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Rubraca.
Nadaljnje informacije za zdravilo Rubraca so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/Rubraca.
The European Medicines Agency decided that although further study was needed to better understand the size of the benefit, Rubraca's benefits are greater than its risks and it can be authorised for use in the EU.
Evropska agencija za zdravila je zaključila, da je sicer potrebna dodatna študija, ki bo omogočila boljše razumevanje obsega koristi, vendar so koristi zdravila Rubraca večje od z njim povezanih tveganj, in se lahko odobri za uporabo v EU.
Rubraca received a conditional marketing authorisation valid throughout the EU on 24 May 2018.
Za zdravilo Rubraca je bilo 24. maja 2018 izdano pogojno dovoljenje za promet, veljavno po vsej EU.
An overview of Rubraca and why it is authorised in the EU
Pregled zdravila Rubraca in zakaj je odobreno v EU
Why is Rubraca authorised in the EU?
Zakaj je bilo zdravilo Rubraca odobreno v EU?
In addition, fewer liver and blood-related problems occur with Rubraca than with other existing treatments for these patients.
Poleg tega se pri zdravilu Rubraca pojavlja manj težav z jetri in krvjo kot pri drugih obstoječih zdravljenjih za te bolnice.
Of the 79 patients whose disease had responded in the past to platinumbased medicines, 65% (51 patients) had a response to treatment with Rubraca and the response lasted on average 294 days (around 10 months).
Od 79 bolnic, katerih bolezen se je v preteklosti odzvala na zdravila na osnovi platine, se je 65 % (51 bolnic) odzvalo na zdravljenje z zdravilom Rubraca, odziv pa je trajal povprečno 294 dni (približno 10 mesecev).
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Rubraca have been included in the summary of product characteristics and the package leaflet.
Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Rubraca upoštevati zdravstveni delavci in bolnice, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
What is Rubraca and what is it used for?
Kaj je zdravilo Rubraca in za kaj se uporablja?
The company will also provide further data on maintenance treatment, including data on how long patients survived with Rubraca.
Podjetje bo zagotovilo tudi dodatne podatke o vzdrževalnem zdravljenju, vključno s podatki o času preživetja bolnic, ki prejemajo zdravilo Rubraca.
What benefits of Rubraca have been shown in studies?
Kakšne koristi zdravila Rubraca so se pokazale v študijah?
As for all medicines, data on the use of Rubraca are continuously monitored.
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Rubraca stalno spremljajo.
Women must not breastfeed during treatment with Rubraca and for at least 2 weeks after treatment.
Ženske med zdravljenjem z zdravilom Rubraca in še vsaj dva tedna po zdravljenju ne smejo dojiti.
Rubraca has been given ‘conditional authorisation'.
Zdravilo Rubraca je pridobilo „pogojno dovoljenje za promet“.
For such patients, tests for a genetic mutation (BRCA mutation) should be carried out first to see if Rubraca is likely to work for them.
Pri teh bolnicah je treba najprej opraviti testiranje za gensko mutacijo (mutacija v genu BRCA), da se ugotovi, ali je verjetno, da bo zdravilo Rubraca zanje primerno.
The most common side effects with Rubraca (which may affect more than 1 in 5 people) are tiredness or weakness, nausea (feeling sick), increased levels of creatinine (which may indicate kidney problems) and liver enzymes in the blood (which may indicate liver damage), vomiting, anaemia (low red blood cell counts), decreased appetite, dysgeusia (taste disturbances), diarrhoea, thrombocytopenia (low levels of platelets) and abdominal pain (belly ache).
Najpogostejši neželeni učinki zdravila Rubraca (ki se lahko pojavijo pri več kot 1 od 5 bolnic) so utrujenost ali oslabelost, navzeja (siljenje na bruhanje), zvišane ravni kreatinina (kar lahko kaže na težave z ledvicami) in jetrnih encimov v krvi (kar lahko kaže na poškodbo jeter), bruhanje, anemija (nizko število rdečih krvnih celic), zmanjšan tek, disgevzija (spremembe v okušanju hrane), driska, trombocitopenija (nizko število krvnih ploščic) ter bolečine v trebuhu.
For more information about using Rubraca, see the package leaflet or contact your doctor or pharmacist.
Za več informacij glede uporabe zdravila Rubraca glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
Side effects reported with Rubraca are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri zdravilu Rubraca, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnic.
It can also be used if the patient's cancer has returned or is worsening after two treatments with platinum-based medicines and they can no longer have these medicines.
Uporablja se lahko tudi, če se je rak pri bolnici ponovil ali poslabšal po dveh zdravljenjih z zdravili na osnovi platine in teh zdravil ne more več uporabljati.
Rubraca can only be obtained with a prescription and treatment should be started and supervised by a doctor who has experience in the treatment of cancer.
Predpisovanje in izdaja zdravila Rubraca je le na recept, zdravljenje z njim pa mora uvesti in nadzorovati zdravnik, ki ima izkušnje z zdravljenjem raka.
In normal cells there is an alternative mechanism for repairing DNA but this alternative mechanism does not work properly in cancer cells with mutations in the BRCA genes.
V normalnih celicah obstaja alternativni mehanizem popravljanja DNK, ki pa v rakavih celicah z mutacijami v genu BRCA ne deluje pravilno.
Other information about Rubraca
Druge informacije o zdravilu Rubraca
What are the risks associated with Rubraca?
Kakšna tveganja so povezana z zdravilom Rubraca?
Two other studies looked at 106 patients with ovarian cancer and BRCA mutation whose cancer had come back following at least 2 previous cancer treatments, including in many cases treatment with platinum-based medicines.
V drugih dveh študijah so proučevali 106 bolnic z rakom jajčnikov in mutacijo v genu BRCA, pri katerih se je rak po vsaj dveh predhodnih zdravljenjih ponovil, v številnih primerih tudi po zdravljenju z zdravili na osnovi platine.
The active substance in Rubraca, rucaparib, blocks the activity of a family of proteins called poly(ADPribose) polymerases (PARPs) that help to repair damaged DNA in cells (both normal and cancer cells).
Učinkovina v zdravilu Rubraca, rukaparib, zavira aktivnost družine beljakovin, imenovanih poli (ADPriboza) polimeraze (PARP), ki pomagajo popravljati poškodovano DNK v (normalnih in rakavih) celicah.
What information is still awaited for Rubraca?
Katere informacije o zdravilu Rubraca še pričakujemo?
proteins are blocked, the damaged DNA in these cancer cells cannot be repaired, and, as a result, the cancer cells die.
Z zaviranjem beljakovin PARP se poškodovana DNK v teh rakavih celicah torej ne more popraviti in zato rakave celice odmrejo.
Patients given Rubraca lived for 11 months without the disease coming back or getting worse compared with 5 months in patients given placebo (a dummy treatment).
Bolnice, ki so prejemale zdravilo Rubraca, so živele 11 mesecev brez ponovnega pojava ali poslabšanja bolezni, tiste, ki so prejemale placebo (zdravilo brez učinkovine), pa pet mesecev.
Since Rubraca has been given conditional authorisation, the company that markets the medicine will provide the results from an ongoing study comparing Rubraca with chemotherapy (another cancer medicine) in patients with high-grade epithelial cancer of the ovary, of the fallopian tubes or of the peritoneum with BRCA mutation whose cancer has come back after chemotherapy treatments.
Ker je zdravilo Rubraca pridobilo pogojno dovoljenje za promet, bo podjetje, ki ga trži, zagotovilo rezultate iz študije, ki poteka in v kateri primerjajo zdravilo Rubraca s kemoterapijo (drugim zdravilom za zdravljenje raka) pri bolnicah z epitelijskim rakom jajčnikov, jajcevodov ali peritonealnega raka visoke stonje z mutacijo v genu BRCA, pri katerih se je rak po zdravljenju s kemoterapijo ponovil.
Rubraca was also beneficial to patients whose cancer had come back after 2 previous cancer treatments, although these benefits have only been shown in patients with a BRCA mutation.
Zdravilo Rubraca je koristilo tudi bolnicam, katerih rak se je ponovil po dveh predhodnih zdravljenjih raka, vendar so se ti učinki pokazali le pri bolnicah z mutacijo v genu BRCA.
For maintenance treatment, Rubraca should be used no later than 8 weeks after the patient has finished their treatment with platinum-based medicine.
Pri vzdrževalnem zdravljenju je treba zdravilo Rubraca uporabiti najpozneje osem tednov po končanem zdravljenju z zdravilom na osnovi platine.
Rubraca as maintenance treatment was investigated in a study of 564 patients with ovarian cancer which had cleared (partially or completely) after treatment with platinum-based cancer medicines.
Zdravilo Rubraca so kot vzdrževalno zdravljenje proučevali v študiji s 564 bolnicami z rakom jajčnikov, ki je (delno ali v celoti) izginil po zdravljenju z zdravili za zdravljenje raka na osnovi platine.
How is Rubraca used?
Kako se zdravilo Rubraca uporablja?
It can be used as maintenance treatment in patients whose recurring cancer has cleared (partially or completely) after treatment with platinum-based cancer medicines.
Zdravilo Rubraca se lahko uporablja za vzdrževalno zdravljenje pri bolnicah, pri katerih je ponovljeni rak (delno ali v celoti) izginil po zdravljenju z zdravili za zdravljenje raka na osnovi platine.
This benefit was seen in patients with or without the BRCA mutation.
Ta učinek je bil viden pri bolnicah z mutacijo v genu BRCA ali brez nje.
Rubraca is a cancer medicine for treating high-grade cancers of the ovary, fallopian tubes (the tubes connecting ovaries to the uterus) and the peritoneum (the membrane lining the abdomen).
Rubraca je zdravilo za zdravljenje raka jajčnikov, jajcevodov (cevastih organov, ki povezujejo jajčnike z maternico) in peritonealnega (mrena v trebušni votlini) raka visoke stopnje.
This benefit with Rubraca was seen in patients with or without the BRCA mutation.
Ta učinek zdravila Rubraca je bil viden pri bolnicah z mutacijo v genu BRCA ali brez nje.
How does Rubraca work?
Kako zdravilo Rubraca deluje?