FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Slovenian: 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.
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Egrifta did not outweigh its risks.
Slovenian: Zato je CHMP v času umika menil, da koristi zdravila Egrifta ne odtehtajo z njim povezanih tveganj.
English: 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.
Slovenian: Zdravilna učinkovina v zdravilu Egrifta, tesamorelin, deluje podobno kot sprožilec izločanja humanega rastnega hormona (GRF), tj. hormon v telesu, ki spodbuja izločanje rastnega hormona.
English: What was Egrifta expected to be used for?
Slovenian: Za kaj naj bi se zdravilo Egrifta uporabljalo?
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: How is Egrifta expected to work?
Slovenian: Kako naj bi zdravilo Egrifta delovalo?
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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).
English: 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.
Slovenian: Zdravilo Egrifta naj bi se uporabljalo za zdravljenje prekomerne trebušne maščobe pri bolnikih, okuženih z virusom HIV, pri katerih se pojavlja lipodistrofija.
English: This summary was last updated in 06-2013.
Slovenian: Povzetek je bil nazadnje posodobljen 06-2013.
English: EMA/282918/2013
Slovenian: EMA/414373/2013 EMEA/H/C/002522
English: What is MACI and what is it used for?
Slovenian: Kaj je zdravilo MACI in za kaj se uporablja?
English: The full EPAR for MACI can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: 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.
English: This is a summary of the European public assessment report (EPAR) for MACI.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo MACI.
English: What measures are being taken to ensure the safe and effective use of MACI?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe
English: The study involved 144 adults with defects ranging between 3 and 20 cm2 in area.
Slovenian: V študijo je bilo vključenih 144 odraslih s poškodbami velikosti od 3 do 20 cm2.
English: A risk management plan has been developed to ensure that MACI is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila MACI je bil pripravljen načrt obvladovanja tveganj.
English: What benefits of MACI have been shown in studies?
Slovenian: Kakšne koristi je zdravilo MACI izkazalo v študijah?
English: What are the risks associated with MACI?
Slovenian: Kakšna tveganja so povezana z zdravilom MACI?
English: This is a type of medicine containing cells or tissues that have been manipulated so that they can be used to repair, regenerate
Slovenian: Gre za skupino zdravil, ki vsebujejo celice ali tkiva, ki so bili spremenjeni tako, da se lahko uporabljajo za obnovitev, regeneracijo ali nadomeščanje tkiva.
English: It is not intended to provide practical advice on how to use MACI.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: The European Commission granted a marketing authorisation valid throughout the European Union for
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom MACI, veljavno po vsej Evropski uniji, odobrila
English: 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).
Slovenian: 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).
English: 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.
Slovenian: 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
English: 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.
Slovenian: 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.
English: For more information about treatment with MACI, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: 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.
English: MACI must also not be used in patients whose growth plates in the thigh bone have not fully closed.
Slovenian: Zdravilo MACI se prav tako ne sme uporabljati pri bolnikih, katerih rastne ploščice v stegenski kosti se še niso povsem zaprle.
English: How does MACI work?
Slovenian: Kako zdravilo MACI deluje?
English: The cells are then placed onto the collagen membrane.
Slovenian: Celice se nato nanesejo na kolagensko membrano.
English: As MACI is an advanced therapy product, it was initially assessed by the Committee for Advanced Therapies (CAT).
Slovenian: Ker je zdravilo MACI izdelek za napredno zdravljenje, ga je naprej ocenil Odbor za napredno zdravljenje (CAT).
English: MACI is an advanced therapy product called a ‘tissue engineered product'.
Slovenian: Zdravilo MACI je vrsta zdravila za napredno zdravljenje, ki se imenuje „izdelek tkivnega inženirstva“.
English: The CHMP therefore concluded that MACI's benefits are greater than its risks and recommended that it
Slovenian: CHMP je tako zaključil, da so koristi zdravila MACI večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: Sestavljajo ga bolnikove lastne hrustančne celice na kolagenskih membranah površine 14,5 cm2, ki jih kirurg vstavi na mesta, kjer je hrustanec poškodovan.
English: The CHMP's recommendation is based on an initial assessment by the CAT.
Slovenian: Priporočilo CHMP temelji na prvotni oceni Odbora za napredno zdravljenje.
English: 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.
Slovenian: Zdravilo MACI se ne sme uporabljati pri bolnikih s hudim osteoartritisom (oteklostjo in bolečino) kolena, vnetno boleznijo sklepa ali nekorigirano prirojeno motnjo strjevanja krvi.
English: 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.
Slovenian: 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.
English: In the first stage of treatment, a sample of cartilage cells is taken from the patient's joint and grown in a laboratory.
Slovenian: V prvi fazi zdravljenja se iz bolnikovega sklepa odvzame vzorec hrustančnih celic in razmnoži v laboratoriju.
English: 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).
Slovenian: 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.
English: 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.
Slovenian: 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.
English: In addition, patients treated with MACI had fewer side effects compared with microfracture
Slovenian: Poleg tega so imeli bolniki, zdravljeni z zdravilom MACI, manj neželenih učinkov v primerjavi z bolniki, zdravljenimi s postopkom mikrofrakture.
English: Growth plates close (or harden) when a child has become skeletally mature and their bones have stopped growing.
Slovenian: Rastne ploščice se zaprejo (ali utrdijo), ko otrokovo okostje dozori in njegove kosti prenehajo
English: 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.
Slovenian: Po približno 6 tednih kirurg oblikuje membrano tako, da se prilega poškodovanemu mestu v kolenskem hrustancu, in jo vsadi s kirurškim posegom.
English: 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.
Slovenian: 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
English: 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.
Slovenian: 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.
English: matrix applied characterised autologous cultured chondrocytes
Slovenian: na matriks naneseni karakterizirani avtologni gojeni hondrociti
English: The active substance in MACI consists of the patient's own cartilage cells, which are implanted into the cartilage defect in the knee.
Slovenian: Zdravilna učinkovina zdravila MACI je sestavljena iz bolnikovih lastnih hrustančnih celic, ki se vsadijo v okvarjen hrustanec v kolenu.
English: MACI should only be used by a surgeon specifically trained and qualified to use it and the product can
Slovenian: Zdravilo MACI lahko vsadi le kirurg, ki je posebej usposobljen za njegovo uporabo, izdaja zdravila pa je le na recept.
English: 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
Slovenian: že uveljavljena v klinični praksi in da so rezultati glavne študije skladni z rezultati v znanstveni literaturi.
English: For both pain and function, improvements of around 45 points were seen in MACI patients compared with around 35 points in patients that
Slovenian: 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.
English: MACI is an implant used to repair cartilage defects at the ends of the bones of the knee joint.
Slovenian: Zdravilo MACI je vsadek, ki se uporablja za popravljanje okvar hrustanca na skrajnih delih kosti kolenskega sklepa.
English: Excess cartilage growth and detachment of the implant may occur in between 1 and 10 patients in 1,000 treated with MACI.
Slovenian: Od 1 do 10 bolnikov od 1 000, zdravljenih z zdravilom MACI, lahko prizadeneta pretirana rast hrustanca in odcepitev vsadka.
English: For practical information about using MACI, patients should read the package leaflet or contact their
Slovenian: Za praktične informacije o uporabi zdravila MACI naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: For the full list of all side effects reported with MACI,
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila MACI, glejte navodilo za uporabo.
English: A type of glue known as a fibrin sealant, which is made from blood clotting proteins, is used to hold the implant in place on the cartilage.
Slovenian: Vsadek se na hrustanec pritrdi s fibrinskim lepilom, izdelanim iz beljakovin, ki povzročajo
English: • major depression;
Slovenian: • velikimi depresivnimi motnjami;
English: A response is usually seen in two to four weeks.
Slovenian: Do odziva na zdravilo običajno pride v dveh do štirih tednih.
English: • generalised anxiety disorder (long-term anxiety or nervousness about everyday matters).
Slovenian: • splošno anksiozno motnjo (dolgotrajno anksioznostjo ali živčnostjo zaradi vsakdanjih stvari).
English: Most patients will need to take 60 mg per day.
Slovenian: Večina bolnikov bo morala jemati odmerek 60 mg na dan.
English: • pain due to diabetic peripheral neuropathy (damage to the nerves in the extremities that can occur in patients with diabetes);
Slovenian: • bolečinami zaradi diabetične periferne nevropatije (poškodbe živcev v okončinah, ki se lahko pojavijo pri bolnikih s sladkorno boleznijo);
English: The full EPAR and risk management plan summary for Duloxetine Mylan can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) in povzetek načrta obvladovanja tveganj za zdravilo Duloksetin Mylan sta na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: ‘Gastroresistant' means that the capsules' contents pass through the stomach without being broken down until they reach the intestine.
Slovenian: „Gastrorezistentne“ pomeni, da vsebina kapsul potuje skozi želodec, razgrajevati pa se začne šele, ko prispe v črevesje.
English: This is a summary of the European public assessment report (EPAR) for Duloxetine Mylan.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Duloksetin Mylan.
English: By blocking their re-uptake, duloxetine increases the amount of these neurotransmitters in the spaces between these nerve cells, increasing the level of communication between the cells.
Slovenian: Duloksetin z zaviranjem njihovega ponovnega prevzema povečuje količino teh živčnih prenašalcev v prostorih med živčnimi celicami in s tem poveča stopnjo komunikacije med celicami.
English: It works by preventing the neurotransmitters serotonin (5-hydroxytryptamine) and noradrenaline from being taken back up into nerve cells in the brain and spinal cord.
Slovenian: Deluje tako, da preprečuje ponovni prevzem živčnih prenašalcev serotonina (5-hidroksitriptamina) in noradrenalina v živčne celice v možganih in hrbtenjači.
English: Duloxetine Mylan is used to treat adults with the following diseases:
Slovenian: Zdravilo Duloksetin Mylan se uporablja za zdravljenje odraslih z naslednjimi boleznimi:
English: The European Commission granted a marketing authorisation valid throughout the European Union for Duloxetine Mylan on 19 June 2015.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Duloksetin Mylan, veljavno po vsej Evropski uniji, izdala 19. junija 2015.
English: Duloxetine Mylan is available as gastroresistant capsules (30 and 60 mg).
Slovenian: Zdravilo Duloksetin Mylan je na voljo v obliki gastrorezistentnih kapsul (30 mg in 60 mg).
English: This means that Duloxetine Mylan is similar to a ‘reference medicine' already authorised in the European Union (EU) called Cymbalta.
Slovenian: To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Cymbalta.
English: The Committee recommended that Duloxetine Mylan be approved for use in the EU.
Slovenian: Priporočil je, da se zdravilo Duloksetin Mylan odobri za uporabo v EU.
English: In patients who respond to Duloxetine Mylan, treatment should continue for several months to prevent the disease coming back, or for longer in patients who have had repeated periods of depression in the past.
Slovenian: Pri bolnikih, ki se odzovejo na zdravilo Duloksetin Mylan, naj bi zdravljenje potekalo več mesecev, da se prepreči ponoven pojav bolezni, v kolikor so bolniki v preteklosti imeli ponavljajoča se obdobja depresije, pa še dlje.
English: What measures are being taken to ensure the safe and effective use of Duloxetine Mylan?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Duloksetin Mylan?
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Duloxetine Mylan has been shown to have comparable quality and to be bioequivalent to Cymbalta.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP), ki deluje pri agenciji, je zaključil, da je bilo v s skladu z zahtevami EU dokazano, da ima zdravilo Duloksetin Mylan primerljivo raven kakovosti kot zdravilo Cymbalta ter da mu je biološko enakovredno.
English: For more information about treatment with Duloxetine Mylan, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Duloksetin Mylan preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: For generalised anxiety disorder, the recommended starting dose is 30 mg once a day, but the dose can be increased to 60, 90 or 120 mg depending on the patient's response.
Slovenian: Pri splošni anksiozni motnji je priporočeni začetni odmerek 30 mg enkrat na dan, vendar se lahko glede na odziv bolnika odmerek poveča na 60, 90 ali 120 mg.
English: A risk management plan has been developed to ensure that Duloxetine Mylan is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila Duloksetin Mylan je bil pripravljen načrt obvladovanja tveganj.
English: Patients who also have major depression should start with 60 mg once a day.
Slovenian: Pri bolnikih, ki imajo tudi velike depresivne motnje, naj bo začetni odmerek 60 mg enkrat na dan.
English: What are the benefits and risks of Duloxetine Mylan?
Slovenian: Kakšne so koristi in tveganja, povezani z zdravilom Duloksetin Mylan?
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Duloxetine Mylan, including the appropriate precautions to be followed by healthcare professionals and patients.
Slovenian: V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
English: Duloxetine Mylan duloxetine
Slovenian: Duloksetin Mylan duloksetin
English: For major depression, the recommended dose of Duloxetine Mylan is 60 mg once a day.
Slovenian: Pri zdravljenju velikih depresivnih motenj je priporočeni odmerek zdravila Duloksetin Mylan 60 mg enkrat dnevno.
English: For practical information about using Duloxetine Mylan, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Duloksetin Mylan naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.