FrancophonIA/ELRC3.0 huggingface dataset:
English: The solution for injection should not be use after the expiry date which is stated on the carton and/or ampoule after EXP.
Slovenian: Raztopino za injiciranje ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli poleg oznake Uporabno do. Datum izteka roka uporabnosti se nanaša na zadnji dan navedenega meseca.
English: STATEMENT OF ACTIVE SUBSTANCE(S)
Slovenian: SEZNAM POMOŽNIH SNOVI [izpolni država članica]
English: Rare (1/10,000 to <1/1,000)
Slovenian: Redki ≥ 1/10.000 do < 1/1.000
English: Clearance is predominantly by hepatic metabolism.
Slovenian: Izločanje v glavnem poteka prek jetrne presnove.
English: Kytril is used to prevent or treat nausea and vomiting (feeling and being sick) caused by other medical treatments, such as chemotherapy or radiotherapy for cancer.
Slovenian: Zdravilo Kytril prepreči ali odpravi slabost in bruhanje, ki sta posledici drugega zdravljenja, kot sta kemoterapija ali radioterapija za zdravljenje raka.
English: You will be given the injection before your radio- or chemotherapy starts.
Slovenian: Preprečevanje slabosti ali bruhanja po radio- ali kemoterapiji Injekcijo boste prejeli pred začetkom radio- ali kemoterapije.
English: Kytril has no or negligible affect on your ability to drive or use any tools or machines.
Slovenian: Zdravilo Kytril nima ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
English: Common 1/100 to <1/10;
Slovenian: Občasni ≥ 1/1.000 do < 1/100;
English: Hypersensitivity reactions e.g. anaphylaxis, urticaria
Slovenian: Občasni preobčutljivostne reakcije kot sta anafilaksija, koprivnica
English: If you think you have taken too many of the tablets talk to your doctor or nurse.
Slovenian: Če ste vzeli večji odmerek zdravila Kytril, kot bi smeli Če menite, da ste vzeli preveč tablet, se posvetujte z vašim zdravnikom ali medicinsko sestro.
English: QT prolongation
Slovenian: Srčne bolezni Občasni podaljšanje QT intervala
English: Treatment of feeling or being sick
Slovenian: Zdravljenje slabosti in bruhanja
English: Hepatic impairment
Slovenian: Zelo pogosti glavobol
English: • medicines used to treat an irregular heartbeat other ‘5-HT3 receptor antagonist' medicines such as dolasetron or ondansetron (see “Take special care with Kytril” above)
Slovenian: • druge antagoniste receptorjev 5-HT3, kot je dolasetron ali ondansetron (glejte zgornji odstavek ''Bodite posebno pozorni pri uporabi zdravila Kytril'');
English: • constipation.
Slovenian: • zaprtje.
English: The solution should be diluted to 5ml per mg. Further maintenance doses of Kytril solution for injection may be administered at least 10 minutes apart.
Slovenian: Nadaljnje vzdrževalne odmerke Kytril raztopine za injiciranje lahko damo v vsaj 10 minutnih presledkih.
English: Children should not be given this injection to treat sickness or the feeling of sickness after surgery.
Slovenian: Uporaba pri otrocih za preprečevanje ali zdravljenje slabosti in bruhanja po operaciji Otroci ne smejo prejeti teh injekcij za zdravljenje slabosti ali bruhanja po operaciji.
English: As for other 5-HT3 antagonists, ECG changes including QT interval prolongation have been reported with granisetron.
Slovenian: Tako kot pri drugih antagonistih tipa 5-HT3, so tudi pri granisetronu poročali o spremembah EKG, vključno s podaljšanjem intervala QT.
English: Uncommon: affects 1 to 10 users in 1,000
Slovenian: Občasni: pojavijo se pri 1 do 10 bolnikih od 1.000 bolnikov
English: Prevention of feeling or being sick
Slovenian: Preprečevanje slabosti in bruhanja
English: Always take Kytril exactly as your doctor has told you.
Slovenian: Pri jemanju zdravila Kytril natančno upoštevajte zdravnikova navodila.
English: PHARMACEUTICAL FORM AND CONTENTS Solution for injection.
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA raztopina za injiciranje [izpolni država članica]
English: In elderly subjects after single intravenous doses, pharmacokinetic parameters were within the range found for non-elderly subjects.
Slovenian: Po enkratnem intravenskem odmerku so bili farmakokinetični parametri pri starejših v podobnih mejah kot pri odraslih.
English: Kytril solution for injection is indicated for the prevention of delayed nausea and vomiting associated with chemotherapy and radiotherapy.
Slovenian: Kytril raztopina za injiciranje je indicirana za preprečevanje zapoznele slabosti in bruhanja, ki sta posledici kemoterapije in radioterapije.
English: Marketing Authorisation Holder and Manufacturer [To be completed nationally]
Slovenian: Imetnik dovoljenja za promet z zdravilom in izdelovalec [izpolni država članica]
English: A dose of 1-3 mg (10-40 g/kg) of Kytril solution for injection should be administered either as a slow intravenous injection or as a diluted intravenous infusion 5 minutes prior to the start of chemotherapy.
Slovenian: Preprečevanje (akutne in zapoznele slabosti): 1 do 3-mg odmerek (10-40 μg/kg) Kytril raztopine za injiciranje je treba dati 5 minut pred začetkom kemoterapije kot počasno intravensko injekcijo ali razredčeno intravensko infuzijo.
English: Kytril film-coated tablets are indicated in adults for the prevention and treatment of acute nausea and vomiting associated with chemotherapy and radiotherapy.
Slovenian: Kytril filmsko obložene tablete so pri odraslih indicirane za preprečevanje in zdravljenje akutne slabosti in bruhanja, ki sta posledici zdravljenja s kemoterapijo in radioterapijo.
English: The injection into your veins will take between 30 seconds and 5 minutes and the dose will usually be 1 mg.
Slovenian: Zdravljenje slabosti ali bruhanja po operaciji Injekcija v veno bo trajala med 30 sekund in 5 minut, odmerek pa bo običajno 1 mg.
English: LIST OF EXCIPIENTS Lactose monohydrate See the leaflet for further information.
Slovenian: SEZNAM POMOŽNIH SNOVI laktoza monohidrat
English: HOW TO STORE KYTRIL
Slovenian: SHRANJEVANJE ZDRAVILA KYTRIL
English: NAME OF THE MEDICINAL PRODUCT Kytril and associated names (see Annex I) 1 mg film-coated tablets Kytril and associated names (see Annex I) 2 mg film-coated tablets [See Annex I - To be completed nationally] Granisetron
Slovenian: Kytril in povezana imena (glejte Prilogo I ) 1 mg filmsko obložene tablete Kytril in povezana imena (glejte Prilogo I ) 2 mg filmsko obložene tablete [glejte Prilogo I - izpolni država članica] granisetron
English: NAME OF THE MEDICINAL PRODUCT Kytril and associated names (see Annex I) 1 mg film-coated tablets Kytril and associated names (see Annex I) 2 mg film-coated tablets [See Annex I - To be completed nationally]
Slovenian: Kytril in povezana imena (glejte Prilogo I ) 1 mg filmsko obložene tablete Kytril in povezana imena (glejte Prilogo I ) 2 mg filmsko obložene tablete [glejte Prilogo I - izpolni država članica]
English: Kytril film-coated tablets are indicated in adults for prevention of delayed nausea and vomiting associated with chemotherapy and radiotherapy.
Slovenian: Kytril filmsko obložene tablete so pri odraslih indicirane za preprečevanje zapoznele slabosti in bruhanja, ki sta posledici zdravljenja s kemoterapijo in radioterapijo.
English: Each film-coated tablet contains 2 mg granisetron (as hydrochloride).
Slovenian: Ena filmsko obložena tableta vsebuje 2 mg granisetrona (v obliki granisetronijevega klorida).
English: Check with your doctor, nurse or pharmacist before using Kytril if you:
Slovenian: Pred uporabo zdravila Kytril se posvetujte s svojim zdravnikom, medicinsko sestro ali s farmacevtom če:
English: Each ml solution for injection contains 0.6 mg granisetron (as hydrochloride).
Slovenian: En ml raztopine za injiciranje vsebuje 0,6 mg granisetrona (v obliki granisetronijevega klorida).
English: Each film-coated tablet contains 1 mg granisetron (as hydrochloride).
Slovenian: Ena filmsko obložena tableta vsebuje 1 mg granisetrona (v obliki granisetronijevega klorida).
English: 4.4 Special warnings and precautions for use As granisetron may reduce lower bowel motility, patients with signs of sub-acute intestinal obstruction should be monitored following its administration.
Slovenian: Bolnike, ki imajo znake subakutne črevesne zapore, je treba skrbno nadzorovati, ker lahko granisetron zmanjša motiliteto spodnjega dela črevesja.
English: 6.1 List of excipients [To be completed nationally]
Slovenian: 6.1 Seznam pomožnih snovi [izpolni država članica]
English: These include dolasetron, ondansetron used like Kytril in the treatment and prevention of nausea and vomiting.
Slovenian: • jemljete druge antagoniste receptorjev 5-HT3 kot sta dolasetron, ondansetron, ki se uporabljata kot zdravilo Kytril za zdravljenje in preprečevanje slabosti in bruhanja;
English: If you are not sure, talk to your doctor, nurse or pharmacist before having the injection.
Slovenian: Če ste negotovi, se predno prejmete injekcijo, posvetujte s svojim zdravnikom, medicinsko sestro ali s farmacevtom.
English: HOW KYTRIL WILL BE GIVEN
Slovenian: KAKO BOSTE PREJELI ZDRAVILO KYTRIL
English: Check with your doctor, nurse or pharmacist before using these tablets, if you:
Slovenian: Pred uporabo teh tablet se posvetujte s svojim zdravnikom, medicinsko sestro ali s farmacevtom če:
English: Each ml solution for injection contains 3 mg granisetron (as hydrochloride).
Slovenian: En ml raztopine za injiciranje vsebuje 3 mg granisetrona (v obliki granisetronijevega klorida).
English: 4.5 Interaction with other medicinal products and other forms of interaction As for other 5-HT3 antagonists, cases of ECG modifications including QT prolongation have been reported with granisetron.
Slovenian: Tako kot pri drugih antagonistih tipa 5-HT3, so tudi pri granisetronu poročali o EKG spremembah, vključno s podaljšanjem QT intervala.
English: BEFORE YOU ARE GIVEN KYTRIL
Slovenian: KAJ MORATE VEDETI, PREDEN BOSTE PREJELI ZDRAVILO KYTRIL
English: Each ml solution for injection contains 1 mg granisetron (as hydrochloride).
Slovenian: En ml raztopine za injiciranje vsebuje 1 mg granisetrona (v obliki granisetronijevega klorida).
English: BATCH NUMBER Batch
Slovenian: ŠTEVILKA SERIJE Serija
English: PACKAGE LEAFLET
Slovenian: Ledvična odpoved
English: Chemo- and radiotherapy-induced nausea and vomiting (CINV and RINV) Prevention (acute and delayed nausea)
Slovenian: - akutne slabosti in bruhanja, ki sta posledici kemoterapije in radioterapije, - pooperativne slabosti in bruhanja.
English: Cross-sensitivity between 5-HT3 antagonists (e.g. dolasteron, ondansetron) has been reported.
Slovenian: • jemljete druge antagoniste 5-HT3, kot sta dolasteron, ondansetron, ki se uporabljata kot
English: The injection into your veins will take between 30 seconds and 5 minutes and the dose will usually be between 1 and 3 mg.
Slovenian: Zdravljenje slabosti ali bruhanja po radio- ali kemoterapiji Injekcija bo trajala od 30 sekund do 5 minut, odmerek pa bo običajno med 1 in 3 mg.
English: 4.2 Posology and method of administration Posology
Slovenian: 4.2 Odmerjanje in način uporabe
English: LIST OF EXCIPIENTS [To be completed nationally]
Slovenian: Pretisni Omoti - [izpolni država članica]
English: Therefore, the Committee considered that these effects need to be closely monitored and managed.
Slovenian: Zato je menil, da je treba te učinke natančno spremljati in nadzirati.
English: The patient's disease should be confirmed by genetic testing whenever possible.
Slovenian: Kadar je mogoče, je treba bolnikovo bolezen potrditi z genetskimi preiskavami.
English: However, the CHMP noted that the long-term benefit for the heart and circulatory system still needed to be confirmed.
Slovenian: Kljub temu pa je opozoril, da je še treba potrditi dolgoročno korist za srce in krvožilni sistem.
English: It is available as capsules (5, 10, 20, 30, 40 and 60 mg) to be taken by mouth on an empty stomach, at least two hours after the evening meal.
Slovenian: Na voljo je v obliki kapsul (5, 10, 20, 30, 40 in 60 mg), ki se jih jemlje peroralno na prazen želodec, najmanj dve uri po večernem obroku.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Lojuxta on 31 July 2013.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Lojuxta, veljavno po vsej Evropski uniji, izdala 31. julija 2013.
English: On average, the patients' LDL cholesterol levels were reduced by 40%.
Slovenian: V povprečju so se ravni LDL-holesterola pri bolnikih znižale za 40 %.
English: It will also contain educational materials to be given to patients, including a brochure and an alert card.
Slovenian: Vsebovalo bo tudi izobraževalno gradivo za bolnike, vključno z brošuro in opozorilno kartico.
English: Lojuxta lomitapide
Slovenian: Lojuxta lomitapid
English: This is a summary of the European public assessment report (EPAR) for Lojuxta.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Lojuxta.
English: The full EPAR for Lojuxta 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 Lojuxta je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Lojuxta's benefits are greater than its risks and recommended that it be approved for use in the EU.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da so koristi zdravila Lojuxta večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
English: Treatment should begin at a dose of 5 mg once per day, and if well tolerated may be steadily increased to a maximum dose of 60 mg per day.
Slovenian: Zdravljenje je treba začeti z odmerkom 5 mg enkrat na dan in ga je mogoče postopoma povečevati do najvišjega odmerka 60 mg na dan, če ga bolnik dobro prenaša.
English: The most common side effects are problems with the gut, which may affect as many as 9 out of 10 people: diarrhoea and nausea (feeling sick) were each seen in around 7 out of 10 people, dyspepsia (heartburn) and vomiting were each seen in more than 3 out of 10 people, while pain, discomfort and bloating of the abdomen (belly), constipation and flatulence were each seen in at least 2 out of 10 people.
Slovenian: Najpogostejši neželeni učinki so težave s prebavili, ki se lahko pojavijo pri 9 ljudeh od 10: drisko in navzejo (slabost) so opazili pri približno 7 osebah od 10, dispepsijo (zgago) in bruhanje so opazili pri več kot 3 osebah od 10, medtem ko so bolečino, neugodje in napihnjenost trebuha, zaprtje in flatulenco opazili pri vsaj 2 osebah od 10.
English: What measures are being taken to ensure the safe and effective use of Lojuxta?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Lojuxta?
English: The study will also provide data on pregnancies in women taking the medicine, and on healthcare professionals' compliance with the recommendations to screen and monitor patients before and during treatment.
Slovenian: S študijo bodo pridobljeni tudi podatki o nosečnostih pri ženskah, ki so jemale zdravilo, in o tem, kako zdravstveni delavci upoštevajo priporočila za presejanje in spremljanje bolnikov pred in med zdravljenjem.
English: Lojuxta was not compared with any other treatment.
Slovenian: Zdravila Lojuxta niso primerjali z nobenim drugim zdravljenjem.
English: Lojuxta has been authorised under ‘exceptional circumstances'.
Slovenian: Zdravilo Lojuxta je pridobilo dovoljenje za promet v „izjemnih okoliščinah“.
English: Patients taking certain other medicines may also need to take a reduced dose or take Lojuxta and their other medication at different times.
Slovenian: Bolniki, ki jemljejo določena druga zdravila, bodo tudi morali jemati zmanjšan odmerek oziroma jemati zdravilo Lojuxta in njihova druga zdravila ob različnih časih.
English: It must also not be used by patients with moderately or severely reduced liver function or with unexplained, abnormal liver test results, or by patients with significant or long-term bowel problems.
Slovenian: Prav tako ga ne smejo uporabljati bolniki z zmerno ali močno zmanjšanim delovanjem jeter, bolniki z nepojasnjenimi, nenormalnimi rezultati preiskav jetrnega delovanja in bolniki s pomembno ali kronično črevesno boleznijo.
English: A risk management plan has been developed to ensure that Lojuxta is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila Lojuxta je bil pripravljen načrt za obvladovanje tveganja.
English: Treatment should be started and monitored by a doctor experienced in treating conditions involving high levels of fats in the blood.
Slovenian: Zdravljenje mora uvesti in spremljati zdravnik z izkušnjami z zdravljenjem visokih ravni maščob v krvi.
English: The Committee also noted that Lojuxta had side effects in the gut in most patients, which caused some patients to stop treatment, and that it led to increased liver enzyme levels whose long-term consequences are not known.
Slovenian: Odbor je opozoril tudi, da je imelo zdravilo Lojuxta pri večini bolnikov neželene učinke na prebavila, zaradi katerih so nekateri bolniki prekinili zdravljenje, in da je povzročilo povišane ravni jetrnih encimov, katerih dolgoročne posledice niso znane.
English: The benefits of Lojuxta in reducing blood cholesterol were assessed in a main study involving 29 patients with homozygous familial hypercholesterolaemia.
Slovenian: Koristi zdravila Lojuxta pri zmanjševanju holesterola v krvi so bile ocenjene v glavni študiji, ki je vključevala 29 bolnikov s homozigotno družinsko hiperholesterolemijo.
English: It is used to treat adult patients with homozygous familial hypercholesterolaemia, an inherited disease causing high blood levels of cholesterol (a type of fat).
Slovenian: Uporablja se za zdravljenje odraslih bolnikov s homozigotno družinsko hiperholesterolemijo, tj. dedno boleznijo, ki povzroča visoke ravni holesterola (vrste maščobe) v krvi.
English: Lojuxta must not be used in women who are pregnant.
Slovenian: Zdravila Lojuxta ne smejo uporabljati nosečnice.
English: By blocking this protein, Lojuxta decreases the level of fats released into the blood, thereby helping to reduce the level of cholesterol in hypercholesterolaemia.
Slovenian: Z zaviranjem tega proteina zdravilo Lojuxta zmanjšuje raven maščob, ki se sproščajo v kri, in na ta način pomaga zmanjševati raven holesterola pri hiperholesterolemiji.
English: Microsomal triglyceride transfer protein is involved in assembling fatty substances such as cholesterol and triglyceride into larger particles called lipoproteins, which are then released into the blood stream.
Slovenian: Mikrosomalni protein za prenos trigliceridov je vključen v sestavljanje maščobnih snovi, kot so holesterol in trigliceridi, v večje dele, imenovane lipoproteini, ki se nato sprostijo v krvni obtok.
English: Other information about Lojuxta
Slovenian: Druge informacije o zdravilu Lojuxta
English: Since Lojuxta has been approved under exceptional circumstances, the company that markets the medicine is carrying out a long-term study in patients taking Lojuxta to provide further data on its safety and effectiveness, including its side effects on the liver, stomach, gut, and cardiovascular system.
Slovenian: Ker je zdravilo Lojuxta pridobilo dovoljenje za promet v izjemnih okoliščinah, bo družba, ki ga trži, opravila dolgoročno študijo pri bolnikih, ki ga jemljejo, s čimer bo zagotovila dodatne podatke o njegovi varnosti in učinkovitosti, vključno z njegovimi neželenimi učinki na jetra, želodec, črevo in srčno-žilni sistem.
English: Lojuxta must not be used together with over 40 mg per day of simvastatin (another medicine used to lower blood cholesterol levels) or with certain other medicines that affect the way lomitapide is broken down in the body.
Slovenian: Zdravila Lojuxta se ne sme uporabljati skupaj z odmerki simvastatina (drugega zdravila za zniževanje ravni holesterola v krvi), ki presegajo 40 mg na dan, ali z določenimi drugimi zdravili, ki vplivajo na razgradnjo lomitapida v telesu.
English: What is Lojuxta and what is it used for?
Slovenian: Kaj je zdravilo Lojuxta in za kaj se uporablja?
English: For more information about treatment with Lojuxta, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Lojuxta preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: Patients should avoid drinking grapefruit juice while taking Lojuxta.
Slovenian: Bolniki se morajo v času jemanja zdravila Lojuxta izogibati pitju soka grenivke.
English: Lojuxta is a medicine that contains the active substance lomitapide.
Slovenian: Lojuxta je zdravilo, ki vsebuje zdravilno učinkovino lomitapid.
English: The most serious side effect seen in some patients treated with Lojuxta is abnormally raised liver enzyme levels.
Slovenian: Najresnejši neželeni učinek, ki se je pojavil pri nekaterih bolnikih, zdravljenih z zdravilom Lojuxta, so bile nenormalno povišane ravni jetrnih encimov.
English: This is because it has not been possible to obtain complete information about Lojuxta to date due to the rarity of the disease.
Slovenian: Do tega je prišlo zato, ker zaradi redkosti bolezni ni bilo mogoče pridobiti vseh informacij o njem.
English: In addition, the company that markets Lojuxta will provide educational materials to all doctors expected to prescribe Lojuxta, containing information on how to select suitable patients as well as key safety information, including side effects, interactions with other medicines and use in women who could potentially have children.
Slovenian: Poleg tega bo družba, ki trži zdravilo Lojuxta, za vse zdravnike, ki naj bi predpisovali to zdravilo, zagotovila izobraževalno gradivo, ki bo vsebovalo informacije o izbiri primernih bolnikov ter ključne varnostne informacije, vključno z neželenimi učinki, medsebojnim delovanjem z drugimi zdravili in uporabo pri ženskah, ki bi lahko bile noseče.
English: What benefits of Lojuxta have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Lojuxta izkazalo v študijah?
English: All patients were given Lojuxta together with other medicines for reducing the level of fats in the blood.
Slovenian: Vsi bolniki so prejeli zdravilo Lojuxta skupaj z drugimi zdravili za zmanjševanje ravni maščob v krvi.
English: What are the risks associated with Lojuxta?
Slovenian: Kakšna so tveganja, povezana z zdravilom Lojuxta?
English: The main measure of effectiveness was the change in the patients' blood levels of ‘low density lipoprotein' (LDL) cholesterol, commonly known as ‘bad cholesterol', after 26 weeks of treatment.
Slovenian: Glavno merilo učinkovitosti je bila sprememba ravni „lipoproteinskega holesterola majhne gostote“ (LDL), ki ga pogosto imenujemo „slabi holesterol“, v krvi bolnikov po 26 tednih zdravljenja.
English: It is not intended to provide practical advice on how to use Lojuxta.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: For practical information about using Lojuxta, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Lojuxta naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: It is used together with a low fat diet and other medicines to reduce the level of fats in the blood.
Slovenian: Uporablja se skupaj s prehrano z majhnim vnosom maščob in z drugimi zdravili za zmanjševanje ravni maščob v krvi.
English: Patients with moderately or severely reduced liver function must not take Lojuxta.
Slovenian: Bolniki z zmerno ali močno zmanjšanim delovanjem jeter zdravila Lojuxta ne smejo jemati.
English: The CHMP considered that the medicine's effect in reducing LDL cholesterol levels was a benefit for patients with homozygous familial hypercholesterolaemia, who have an unmet medical need.
Slovenian: Menil je, da je učinek zdravila pri zniževanju ravni LDL-holesterola koristen za bolnike s homozigotno družinsko hiperholesterolemijo in z neizpolnjeno potrebo po zdravilu.
English: Why is Lojuxta approved?
Slovenian: Zakaj je bilo zdravilo Lojuxta odobreno?