natgillin/translations-raw huggingface dataset:
The effects of Fareston were compared with those of tamoxifen (another anti-oestrogen used to treat breast cancer).
Učinke zdravila Fareston so primerjali z učinki tamoksifena (drugega antiestrogena, ki se uporablja za zdravljenje raka dojk).
Looking at the results of the three largest main studies taken together, patients taking Fareston had similar response rates, times to progression and survival rates as the patients taking tamoxifen.
Primerjava rezultatov treh največjih glavnih študij kaže, da so imele bolnice, ki so jemale zdravilo Fareston, podobno stopnjo odziva, čas do napredovanja bolezni in stopnjo preživetja kot bolnice, ki so jemale tamoksifen.
The Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits and risks of Fareston were comparable to those of tamoxifen in women with oestrogen-receptor-positive tumours.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi in tveganja zdravila Fareston pri ženskah s tumorji, ki so pozitivni za estrogenske receptorje, primerljivi s koristmi in tveganji tamoksifena.
For the full list of all side effects reported with Fareston, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Fareston, glejte navodilo za uporabo.
Fareston is a medicine that contains the active substance toremifene.
Fareston je zdravilo, ki vsebuje zdravilno učinkovino toremifen.
Fareston has been studied in 1,869 postmenopausal women with metastatic breast cancer in four main studies.
Zdravilo Fareston so proučevali v štirih glavnih študijah s 1 869 ženskami po menopavzi, ki so imele metastatski rak dojk.
The active substance in Fareston, toremifene, is an anti-oestrogen.
Zdravilna učinkovina v zdravilu Fareston, toremifen, je antiestrogen.
Most types of breast cancer grow in response to the hormone oestrogen.
Rast večine vrst raka dojk je odvisna od hormona estrogena.
Fareston is not recommended for patients with oestrogen-receptor-negative tumours (where the cancer cells do not have receptors for the hormone oestrogen on their surface).
Zdravilo Fareston ni priporočljivo pri bolnicah s tumorji brez estrogenskih receptorjev (z rakavimi celicami, ki na površini nimajo receptorjev za hormon estrogen).
Why has Fareston been approved?
Zakaj je bilo zdravilo Fareston odobreno?
Fareston is used to treat hormone-dependent metastatic breast cancer in women who have been through the menopause.
Zdravilo Fareston se uporablja za zdravljenje hormonsko odvisnega metastatskega raka dojk pri bolnicah po menopavzi.
It should be used with caution in patients who have problems with their liver.
Pri bolnicah, ki imajo težave z jetri, je treba zdravilo uporabljati previdno.
The effectiveness of Fareston and tamoxifen were equivalent.
Učinkovitost zdravila Fareston je bila enakovredna učinkovitosti tamoksifena.
It must not be used on a long-term basis in patients who have endometrial hyperplasia (thickening of the lining of the womb) or severe liver problems.
Bolnice, ki imajo hiperplazijo endometrija (zadebeljeno maternično sluznico) ali huda obolenja jeter, zdravila ne smejo uporabljati dolgotrajno.
The full EPAR for Fareston can be found here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Fareston je na voljo tukaj.
What is Fareston used for?
Za kaj se zdravilo Fareston uporablja?
Therefore, the Committee decided that Fareston's benefits are greater than its risks for the first line hormone treatment of hormone-dependent metastatic breast cancer in postmenopausal patients.
Odbor je zato sklenil, da so koristi zdravila Fareston pri hormonskem zdravljenju prve izbire hormonsko odvisnega metastatskega raka dojk pri bolnicah po menopavzi večje od z njim povezanih tveganj Odbor je priporočil, da se za zdravilo Fareston odobri dovoljenje za promet.
How has Fareston been studied?
Kako je bilo zdravilo Fareston raziskano?
How does Fareston work?
Kako zdravilo Fareston deluje?
What is Fareston?
Kaj je zdravilo Fareston?
How is Fareston used?
Kako se zdravilo Fareston uporablja?
If you are in a compassionate use programme and need more information about your treatment, contact the doctor who is giving it to you.
Če ste vključeni v program sočutne uporabe zdravila in potrebujete več informacij o zdravljenju, se obrnite na zdravnika, ki vam je predpisal zdravljenje.
In addition, no long-term safety data were provided, although treatment with Egrifta was expected to be long term.
Poleg tega niso bili predloženi nobeni dolgoročni podatki o varnosti, kljub temu da naj bi bilo zdravljenje z zdravilom Egrifta dolgoročno.
The application was withdrawn after the CHMP had evaluated the documentation provided by the company and formulated lists of questions.
Vlogo so umaknili po tem, ko je CHMP ocenil dokumentacijo, ki mu jo je družba predložila, in oblikoval sezname vprašanj.
The company presented the results from two main studies involving 816 HIV patients with excessive accumulation of abdominal fat.
Družba je predložila rezultate dveh glavnih študij, ki sta zajeli 816 bolnikov, okuženih z virusom HIV, pri katerih se je pojavilo prekomerno kopičenje maščobnega tkiva na trebuhu.
Withdrawal of the marketing authorisation application for Egrifta (tesamorelin)
Umik vloge za pridobitev dovoljenja za promet z zdravilom Egrifta (tesamorelin)
Egrifta is a medicine that contains the active substance tesamorelin.
Egrifta je zdravilo, ki vsebuje zdravilno učinkovino tesamorelin.
The relevance of the results was also questioned because the patients in the main studies were not representative of European HIV patients, who have a lower average body mass index (BMI) and smaller amounts of abdominal fats than the patients in the studies.
Odbor je podvomil tudi v relevantnost rezultatov, saj v glavni študiji niso bili vključeni bolniki, ki bi bili reprezentativni za bolnike, okužene z virusom HIV, iz Evrope, ki imajo nižji povprečni indeks telesne mase (ITM) in manjše količine maščobnega tkiva na trebuhu kot bolniki, zajeti v študijah.
The company informed the CHMP that there are no consequences for patients currently included in compassionate use programmes using Egrifta.
Družba je obvestila Odbor CHMP, da umik nima nobenih posledic za bolnike, ki trenutno sodelujejo v programih sočutne uporabe zdravila Egrifta.
High levels of IGF-1 may be associated with an increased risk of cancer and a potential worsening of diabetic eye disease, and the Committee considered this to be a major safety concern.
Visoka raven IGF-1 je lahko vzrok za povečano tveganje za pojav rakavih obolenj in za morebitno poslabšanje diabetične očesne bolezni, zato je odbor ocenil, da zdravilo predstavlja znatno tveganje za varnost bolnikov.
The studies compared Egrifta with placebo (a dummy treatment), and the main measure of effectiveness was the change in abdominal fat after 26 weeks of treatment.
V študijah so zdravilo Egrifta primerjali s placebom (z zdravilom brez zdravilne učinkovine), glavno merilo učinkovitosti pa je bila sprememba maščobnega tkiva na trebuhu po 26 tednih zdravljenja.
It was to be available as a powder to be made up into a solution for injection.
Na voljo naj bi bilo v obliki praška za pripravo raztopine za injiciranje.
In addition, although the main studies showed a reduction in abdominal fat with Egrifta, the reduction has not been shown to be clinically meaningful in terms of actual health benefits to patients.
Poleg tega sta glavni študiji sicer pokazali, da je zdravilo Egrifta pripomoglo k zmanjšanju maščobnega tkiva na trebuhu, vendar ni dokazov, da bi bilo zmanjšanje klinično pomembno v smislu dejanske koristi za zdravje bolnikov.
What is Egrifta?
Kaj je zdravilo Egrifta?
Growth hormone has been shown to play a role in regulating the formation and breakdown of fat tissue.
Rastni hormon dokazano pomaga uravnavati tvorbo in razgradnjo maščobnega tkiva.
On 21 June 2012, Ferrer Internacional, S.A. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Egrifta, for the treatment of excess abdominal fat in HIV patients with lipodystrophy.
Družba Ferrer Internacional, S. A. je dne 21. 6. 2012 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za pridobitev dovoljenja za promet z zdravilom Egrifta, namenjenim zdravljenju prekomerne trebušne maščobe pri bolnikih, okuženih z virusom HIV, pri katerih se pojavlja lipodistrofija.
The CHMP considered a suggestion by the company to restrict the medicine to patients with abdominal fat above a certain amount (defined as greater than 130 cm2), but the evidence supporting the cut-off point was not considered to be sufficient.
Odbor CHMP je proučil predlog družbe, da naj se uporabo zdravila omeji samo za bolnike, katerih maščobno tkivo na trebuhu presega določeno vrednost (več kot 130 cm2), vendar je ocenil, da ni bilo zadostnih dokazov, ki bi podprli omenjeno vrednostno mejo.
In its official letter, the company stated that it decided to withdraw the application because the CHMP considered that the data provided did not allow the Committee to conclude on a positive benefit-risk balance.
Družba je v uradnem dopisu navedla, da se je za umik vloge odločila, ker je CHMP presodil, da na podlagi razpoložljivih podatkov ne more zaključiti, da je razmerje med koristmi in tveganji pozitivno.
Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Egrifta did not outweigh its risks.
Zato je CHMP v času umika menil, da koristi zdravila Egrifta ne odtehtajo z njim povezanih tveganj.
The active substance in Egrifta, tesamorelin, is similar to ‘human growth hormone-releasing factor' (GRF), a hormone in the body that stimulates the release of growth hormone.
Zdravilna učinkovina v zdravilu Egrifta, tesamorelin, deluje podobno kot sprožilec izločanja humanega rastnega hormona (GRF), tj. hormon v telesu, ki spodbuja izločanje rastnega hormona.
What was Egrifta expected to be used for?
Za kaj naj bi se zdravilo Egrifta uporabljalo?
Lipodystrophy is known to occur in some HIV-infected patients, where it leads to the loss of fat in certain areas of the body and sometimes to excessive accumulation of fat in the abdomen.
Pojavlja se pri nekaterih bolnikih, okuženih z virusom HIV, in povzroča izgubo maščobe na nekaterih delih telesa ter včasih prekomerno kopičenje maščobnega tkiva na trebuhu.
The CHMP was concerned about how Egrifta would be used in clinical practice as it would be difficult to differentiate excess abdominal fat due to lipodystrophy from excess fat due to obesity.
Odbor CHPM je izrazil zaskrbljenost glede uporabe zdravila Egrifta v klinični praksi, saj je menil, da bi bilo težko ločiti prekomerno maščobno tkivo na trebuhu, povezano z lipodistrofijo, od prekomernega maščobnega tkiva na trebuhu, ki je posledica debelosti.
How is Egrifta expected to work?
Kako naj bi zdravilo Egrifta delovalo?
Based on the review of the data and the company's responses to the CHMP lists of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Egrifta could not have been approved for the treatment of excess abdominal fat in HIV patients with lipodystrophy.
Odbor CHMP je na podlagi pregleda podatkov in odgovorov družbe na sezname vprašanj, ki jih je zastavil, ob umiku izrazil določene zadržke ter je začasno menil, da zdravila Egrifta ni mogoče odobriti za zdravljenje prekomernega maščobnega tkiva na trebuhu pri bolnikih, okuženih z virusom HIV, pri katerih se pojavlja lipodistrofija.
Tesamorelin is expected to act in a similar way to GRF, causing the release of growth hormone, which is then expected to increase the breakdown of fat in HIV patients with lipodystrophy, thereby reducing excess fat in the abdomen.
Tesamorelin naj bi deloval na podoben način kot GRF, torej spodbujal izločanje rastnega hormona, ki naj bi nato spodbudil razgradnjo maščobnega tkiva pri bolnikih, okuženih z virusom HIV, pri katerih se pojavlja lipodistrofija, ter s tem pomagal zmanjšati odvečno maščobno tkivo na trebuhu.
In terms of safety, the CHMP noted that there was an increase in the level of a protein called insulinlike growth factor 1 (IGF-1) in a considerable number of patients treated with Egrifta.
Pri ocenjevanju varnosti zdravila je odbor CHMP ugotovil, da se je pri znatnem številu bolnikov, ki so prejemali zdravilo Egrifta, zvišala raven beljakovine, ki ji pravimo tudi inzulinu podoben rastni faktor 1 (IGF-1).
Egrifta was expected to be used for the treatment of excess abdominal fat in HIV-infected patients with lipodystrophy, a condition that leads to changes in the distribution of body fat.
Zdravilo Egrifta naj bi se uporabljalo za zdravljenje prekomerne trebušne maščobe pri bolnikih, okuženih z virusom HIV, pri katerih se pojavlja lipodistrofija.
This summary was last updated in 06-2013.
Povzetek je bil nazadnje posodobljen 06-2013.
EMA/282918/2013
EMA/414373/2013 EMEA/H/C/002522
What is MACI and what is it used for?
Kaj je zdravilo MACI in za kaj se uporablja?
The full EPAR for MACI 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 MACI je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
This is a summary of the European public assessment report (EPAR) for MACI.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo MACI.
What measures are being taken to ensure the safe and effective use of MACI?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe
The study involved 144 adults with defects ranging between 3 and 20 cm2 in area.
V študijo je bilo vključenih 144 odraslih s poškodbami velikosti od 3 do 20 cm2.
A risk management plan has been developed to ensure that MACI is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila MACI je bil pripravljen načrt obvladovanja tveganj.
What benefits of MACI have been shown in studies?
Kakšne koristi je zdravilo MACI izkazalo v študijah?
What are the risks associated with MACI?
Kakšna tveganja so povezana z zdravilom MACI?
This is a type of medicine containing cells or tissues that have been manipulated so that they can be used to repair, regenerate
Gre za skupino zdravil, ki vsebujejo celice ali tkiva, ki so bili spremenjeni tako, da se lahko uporabljajo za obnovitev, regeneracijo ali nadomeščanje tkiva.
It is not intended to provide practical advice on how to use MACI.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
The European Commission granted a marketing authorisation valid throughout the European Union for
Evropska komisija je dovoljenje za promet z zdravilom MACI, veljavno po vsej Evropski uniji, odobrila
The other important risks are those related to the surgical procedure itself, including infection, inflammation, haemoarthrosis (blood in the joints), arthrofibrosis (scar tissue in the joints), and thromboembolic events (blood clots).
Druga pomembna tveganja so povezana s samim kirurškim posegom, vključujejo pa okužbo, vnetje, hemartrozo (krvavitev v sklepih), artrofibrozo (brazgotino v sklepih) in tromboembolične dogodke (krvne strdke).
In addition, surgeons and healthcare professionals who will be involved in treating patients with MACI will receive educational materials providing detailed guidance on how to use MACI as well as information on its risks and the need to follow-up patients treated with MACI.
Poleg tega bodo kirurgi in zdravstveni delavci, ki bodo vključeni v zdravljenje bolnikov z zdravilom MACI, prejeli izobraževalno gradivo s podrobnimi napotki glede uporabe zdravila MACI ter informacijami o z njim povezanih tveganjih in potrebi po spremljanju bolnikov, zdravljenih z zdravilom
MACI was evaluated to comply with the EU regulation on advanced therapies, which requires all advanced therapies in EU Member States to undergo an evaluation by the EMA in order to obtain an EU-wide marketing authorisation.
Za zdravilo MACI je bilo ocenjeno, da je skladno z uredbo EU o naprednih zdravljenjih, ki za vsa napredna zdravljenja v državah članicah EU zahteva, da jih Evropska agencija za zdravila oceni, da bi pridobila dovoljenje za promet, ki velja za celotno EU.
For more information about treatment with MACI, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom MACI preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
MACI must also not be used in patients whose growth plates in the thigh bone have not fully closed.
Zdravilo MACI se prav tako ne sme uporabljati pri bolnikih, katerih rastne ploščice v stegenski kosti se še niso povsem zaprle.
How does MACI work?
Kako zdravilo MACI deluje?
The cells are then placed onto the collagen membrane.
Celice se nato nanesejo na kolagensko membrano.
As MACI is an advanced therapy product, it was initially assessed by the Committee for Advanced Therapies (CAT).
Ker je zdravilo MACI izdelek za napredno zdravljenje, ga je naprej ocenil Odbor za napredno zdravljenje (CAT).
MACI is an advanced therapy product called a ‘tissue engineered product'.
Zdravilo MACI je vrsta zdravila za napredno zdravljenje, ki se imenuje „izdelek tkivnega inženirstva“.
The CHMP therefore concluded that MACI's benefits are greater than its risks and recommended that it
CHMP je tako zaključil, da so koristi zdravila MACI večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
The study showed that MACI is more effective than microfracture surgery at relieving pain and improving knee function: two years after surgery, patients treated with MACI had an average score of 82 for pain and 61 for knee function, compared with 71 and 49 respectively for patients treated with microfracture surgery.
Študija je pokazala, da je zdravilo MACI učinkovitejše od postopka mikrofrakture pri lajšanju bolečin in izboljševanju funkcije kolena: dve leti po posegu so bolniki, zdravljeni z zdravilom MACI, imeli povprečen rezultat 82 za bolečino in 61 za funkcijo kolena v primerjavi z 71 točkami za bolečino in 49 točkami za funkcijo kolena pri bolnikih, zdravljenih s postopkom mikrofrakture.
The Agency's Committee for Medicinal Products for Human Use (CHMP) noted that the main study had shown that MACI was superior to microfracture surgery in treating patients with cartilage defects of the knee.
Odbor za zdravila za uporabo v humani medicini (CHMP) agencije je menil, da je glavna študija pokazala, da bilo zdravilo MACI učinkovitejše od postopka mikrofrakture pri zdravljenju bolnikov z okvarami hrustanca v kolenu.
It consists of the patient's own cartilage cells on 14.5 cm2 collagen membranes, which are used by a surgeon to fill in the spaces where cartilage is damaged.
Sestavljajo ga bolnikove lastne hrustančne celice na kolagenskih membranah površine 14,5 cm2, ki jih kirurg vstavi na mesta, kjer je hrustanec poškodovan.
The CHMP's recommendation is based on an initial assessment by the CAT.
Priporočilo CHMP temelji na prvotni oceni Odbora za napredno zdravljenje.
MACI must not be used in patients with severe osteoarthritis (swelling and pain) of the knee, inflammatory joint disease, or uncorrected inborn blood clotting disorders.
Zdravilo MACI se ne sme uporabljati pri bolnikih s hudim osteoartritisom (oteklostjo in bolečino) kolena, vnetno boleznijo sklepa ali nekorigirano prirojeno motnjo strjevanja krvi.
The cells are used to fill in the space where the cartilage has been damaged, thereby regenerating the damaged areas and helping to resolve the patient's symptoms such as pain and problems moving the knee.
Celice so namenjene zapolnjevanju prostora, kjer je hrustanec poškodovan, s čimer se obnovijo poškodovana mesta in olajšajo bolnikovi simptomi, kot so bolečina in težave pri premikanju kolena.
In the first stage of treatment, a sample of cartilage cells is taken from the patient's joint and grown in a laboratory.
V prvi fazi zdravljenja se iz bolnikovega sklepa odvzame vzorec hrustančnih celic in razmnoži v laboratoriju.
MACI is used to repair full-thickness defects with a surface area of between 3 to 20 cm2 in adults who are experiencing symptoms (such as pain and problems moving the knee).
Zdravilo MACI se uporablja za odpravljanje okvar po vsej debelini v obsegu od 3 do 20 cm2 pri odraslih s simptomi, kot so bolečina in težave pri premikanju kolena.
A standard scale, known as the ‘knee injury and osteoarthritis outcome score' (KOOS), was used to measure pain and knee function, where 0 reflects extreme problems and 100 reflects an absence of problems.
Za merjenje bolečine in funkcije kolena je bila uporabljena standardna lestvica KOOS (merjenje izida ob poškodbi kolena in osteoartritisu), pri čemer 0 odraža izjemne težave, 100 pa odsotnost težav.
In addition, patients treated with MACI had fewer side effects compared with microfracture
Poleg tega so imeli bolniki, zdravljeni z zdravilom MACI, manj neželenih učinkov v primerjavi z bolniki, zdravljenimi s postopkom mikrofrakture.
Growth plates close (or harden) when a child has become skeletally mature and their bones have stopped growing.
Rastne ploščice se zaprejo (ali utrdijo), ko otrokovo okostje dozori in njegove kosti prenehajo
Around 6 weeks later, the surgeon shapes the membrane to fit the damaged area in the knee cartilage and then implants it using a surgical procedure.
Po približno 6 tednih kirurg oblikuje membrano tako, da se prilega poškodovanemu mestu v kolenskem hrustancu, in jo vsadi s kirurškim posegom.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for MACI, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za uporabo za zdravilo MACI vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati
MACI was compared with microfracture surgery (a surgical procedure commonly used to treat cartilage defects) in a main study which looked at pain relief and improvements in knee function in patients with full thickness cartilage defects in the knee.
Zdravilo MACI so primerjali s postopkom mikrofrakture (kirurški poseg, ki se pogosto uporablja za zdravljenje okvar hrustanca) v glavni študiji, v kateri so preučevali lajšanje bolečine in izboljšanje funkcije kolena pri bolnikih z okvarami kolenskega hrustanca po vsej debelini.
matrix applied characterised autologous cultured chondrocytes
na matriks naneseni karakterizirani avtologni gojeni hondrociti
The active substance in MACI consists of the patient's own cartilage cells, which are implanted into the cartilage defect in the knee.
Zdravilna učinkovina zdravila MACI je sestavljena iz bolnikovih lastnih hrustančnih celic, ki se vsadijo v okvarjen hrustanec v kolenu.
MACI should only be used by a surgeon specifically trained and qualified to use it and the product can
Zdravilo MACI lahko vsadi le kirurg, ki je posebej usposobljen za njegovo uporabo, izdaja zdravila pa je le na recept.
The Committee noted that treatments such as MACI are already established in clinical practice and that the results from the main study were consistent with results in
že uveljavljena v klinični praksi in da so rezultati glavne študije skladni z rezultati v znanstveni literaturi.
For both pain and function, improvements of around 45 points were seen in MACI patients compared with around 35 points in patients that
V skupnem seštevku je bilo pri bolnikih, zdravljenih z zdravilom MACI, ugotovljeno izboljšanje v vrednosti približno 45 točk v primerjavi s približno 35 točkami pri bolnikih, zdravljenih s postopkom mikrofrakture.
MACI is an implant used to repair cartilage defects at the ends of the bones of the knee joint.
Zdravilo MACI je vsadek, ki se uporablja za popravljanje okvar hrustanca na skrajnih delih kosti kolenskega sklepa.
Excess cartilage growth and detachment of the implant may occur in between 1 and 10 patients in 1,000 treated with MACI.
Od 1 do 10 bolnikov od 1 000, zdravljenih z zdravilom MACI, lahko prizadeneta pretirana rast hrustanca in odcepitev vsadka.