FrancophonIA/ELRC3.0 huggingface dataset:
English: The PRAC concluded that the benefit-risk balance of acipimox-containing products remains favourable under normal conditions of use, subject to the agreed changes to the product information.
Croatian: PRAC je zaključio da omjer koristi i rizika lijekova koji sadrže acipimoks ostaje pozitivan u normalnim uvjetima primjene, uz dogovorene izmjene u informacijama o proizvodu.
English: It was noted that acipimox was of particular use in patients who either do not tolerate statin or fibrates or who do not achieve triglyceride goals with statin or fibrate therapy alone and could therefore be used as an alternative or adjunct treatment to reduce triglyceride levels in these patients.
Croatian: Također je uočeno da je acipimoks bio od posebne koristi u bolesnika koji nisu podnosili statin ili fibrate ili koji nisu postigli ciljne vrijednosti triglicerida monoterapijom statinom ili fibratom, te se stoga mogao koristiti kao alternativno ili dodatno liječenje za snižavanje razine triglicerida u ovih bolesnika.
English: • The review has shown that acipimox can be useful as an additional or alternative treatment to lower high levels of triglycerides (a particular type of fat) in the blood of patients with high levels of these fats (with or without high cholesterol), who cannot be treated by means such as diet, exercise, or other medicines.
Croatian: • Pregledom je dokazano da acipimoks može biti koristan kao dodatna ili alternativna terapija za snižavanje visoke razine triglicerida (poseban tip masti) u krvi bolesnika s visokom razinom ovih masti (s visokim kolesterolom ili bez njega) koji se ne mogu liječiti mjerama poput dijete, vježbanja ili drugim lijekovima.
English: Its uses and safety have been reviewed because of a study showing that a related medicine, nicotinic acid, increased the side effects and gave no additional benefit when it was taken together with other treatments for these disorders.
Croatian: Pregledane su koristi od ovog lijeka i njegova sigurna primjena zbog ispitivanja koje je dokazalo da je povezani lijek, nikotinska kiselina, povećao nuspojave, a nije pružio dodatne koristi ako se uzimao zajedno s drugim terapijama za ove poremećaje.
English: The original reason for the review of acipimox was HPS2-THRIVE, a large study which looked at the long-term effect of the combination of nicotinic acid (a substance related to acipimox) and another medicine, laropiprant, in treating lipid disorders.
Croatian: Prvotni razlog za pregled acipimoksa bilo je ispitivanje HPS2-THRIVE, veliko ispitivanje tijekom kojeg su istraženi dugoročni utjecaji kombinacije nikotinske kiseline (tvari povezane s acipimoksom) i drugog lijeka, laropipranta, u liječenju poremećaja lipida.
English: • Based on the available data, the PRAC noted a number of clinical differences between acipimox and nicotinic acid, with acipimox having a longer duration of action and non-clinical studies showing that acipimox is consistently less potent than nicotinic acid as an agonist of the HCA2 receptor.
Croatian: • Na temelju dostupnih podataka, PRAC je uočio niz kliničkih razlika između acipimoksa i nikotionske kiseline, pri čemu je acipimoks imao dulje djelovanje, a nekliničkim ispitivanjima utvrđeno je da je acipimoks konzistentno imao manji potencijal od nikotinske kiseline kao agonist receptora HCA2.
English: • The main role of acipimox is to prevent the non-cardiovascular complications of hypertriglyceridaemia and acipimox should not be used for the prevention of cardiovascular disease in the absence of convincing LDL-C or outcome data.
Croatian: • Glavna uloga acipimoksa jest sprječavanje drugih komplikacija hipertriglikeridemije osim kardiovaskularnih, te se acipimoks ne smije koristiti za prevenciju kardiovaskularnih bolesti u odsutnosti uvjerljivih razina LDL kolesterola ili podataka o ishodu.
English: The PRAC considered that the available data did not identify any new safety information which impacts the benefit-risk balance of acipimox, with the exception of a potential risk of muscle toxicity associated with the concomitant use of acipimox with statins, which was addressed by adding a warning to the product information.
Croatian: PRAC je zaključio da dostupnim podacima nisu utvrđene nove sigurnosne informacije koje bi mogle imati utjecaja na omjer koristi i rizika acipimoksa, uz iznimku potencijalnog rizika mišićne toksičnosti koja je povezana s istovremenom primjenom acipimoksa i statina, što je opisano dodavanjem upozorenja u informacije o proizvodu.
English: These are conditions involving hypertriglyceridaemia (high levels of triglycerides, a type of fat, in the blood), with or without increased cholesterol.
Croatian: Ova stanja uključuju hipertrigliceridemiju (visoku razinu triglicerida, tipa masti, u krvi) s povišenim kolesterolom ili bez njega.
English: • Acipimox was considered to be efficacious in reducing triglyceride levels in patients with hypertriglyceridaemia (Fredrickson type IV hyperlipoproteinaemia) and significantly superior to placebo in patients with hypercholesterolaemia and hypertriglyceridaemia (Fredrickson type IIb hyperlipoproteinaemia).
Croatian: • Zaključeno je da je acipimoks djelotvoran u snižavanju razina triglicerida u bolesnika s hipertrigliceridemijiom (hiperlipoproteinemija tip IV prema Fredrickson klasifikaciji) i značajno bolji u odnosu na placebo u bolesnika oboljelih od hiperkolesterolemije i hipertrigliceridemije (hiperlipoproteinemija tip IV prema Fredrickson klasifikaciji).
English: Patients receiving acipimox should have their treatment reviewed at their next regular appointment.
Croatian: Terapija bolesnika koji uzimaju acipimoks mora se ponovno razmotriti pri sljedećem redovitom pregledu.
English: • Although the review of acipimox-containing medicines was originally triggered by concerns arising from the HPS2-THRIVE study, the extended release nicotinic acid/laropiprant combination used in that study cannot be regarded as the same as mono-component acipimox and the concerns can therefore not be extrapolated to acipimox, in particular due to the possible confounding effect of laropiprant.
Croatian: • Iako je pregled lijekova koji sadrže acipimoks izvorno potaknut zabrinutošću koja je nastala na temelju ispitivanja HPS2-THRIVE, kombinacija nikotinske kiseline i laropipranta s produljenim otpuštanjem, koja je korištena u ovom ispitivanju, ne može se smatrati istom kao i monokomponenta acipimoks, te se zabrinutost stoga ne može ekstrapolirati na acipimoks, posebice zbog mogućeg istovremenog djelovanja laropipranta.
English: • Patients taking acipimox should have their treatment re-evaluated at their next regular appointment.
Croatian: • Terapija bolesnika koji uzimaju acipimoks mora se ponovno razmotriti pri sljedećem redovitom pregledu.
English: • However, based on the results from HPS2-THRIVE and the chemical similarity of acipimox and nicotinic acid, prescribers should be aware of the potential increased risk of myopathy when acipimox is used in combination with a statin.
Croatian: • No, na temelju rezultata ispitivanja HPS2-THRIVE i kemijske sličnosti acipimoksa i nikotinske kiseline, propisivači moraju biti upoznati s potencijalnim povišenim rizikom od miopatije u slučaju kada se acipimoks koristi u kombinaciji sa statinom.
English: • Acipimox is indicated for the treatment of hypertriglyceridaemia with or without hypercholesterolaemia (Fredrickson type IIb or type IV hyperlipoproteinaemia).
Croatian: • Acipimoks je indiciran za liječenje hipertrigliceridemije s hiperkolesterolemijom (hiperlipoproteinemija tip IIb ili tip IV prema Fredrickson klasifikaciji) ili bez nje.
English: Because acipimox was related to nicotinic acid and was marketed for lipid disorders in the EU, its benefit-risk balance was also then reviewed.
Croatian: Budući da je acipimoks povezan s nikotinskom kiselinom te je stavljen u promet na području EU-a za potrebe liječenja poremećaja lipida, pregledan je i njegov omjer koristi i rizika.
English: However, findings from the HPS2-THRIVE study were used to expand the warnings in the acipimox product information concerning a possible increased risk of painful muscle damage when acipimox is used together with a statin.
Croatian: No, nalazi dobiveni ispitivanjem HPS2-THRIVE korišteni su za proširenje upozorenja u informacijama o lijeku acipimoksu u vezi s mogućim povišenim rizikom od bolnog oštećenja mišića, u slučaju kada se acipimoks koristi zajedno sa statinom.
English: The results from HPS2-THRIVE could not be applied directly to acipimox since the study investigated the effect of the combination with laropiprant, whose effects were not established, and possible differences between
Croatian: Rezultati prikupljeni ispitivanjem HPS2-THRIVE ne mogu se izravno primijeniti na acipimoks budući da je ispitivanje istražilo djelovanje kombinacije s
English: Imlygic talimogene laherparepvec
Croatian: Imlygic talimogen laherparepvec
English: The full EPAR and risk management plan summary for Imlygic can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR kao i sažetak plana upravljanja rizikom za lijek Imlygic nalaze se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The second dose is given three weeks after the first dose and treatment is continued every two weeks for at least six months, unless the doctor considers that the patient is not benefiting from the medicine.
Croatian: Druga doza daje se tri tjedna nakon prve doze, a liječenje se nastavlja svaka dva tjedna najmanje šest mjeseci, osim ako liječnik smatra da bolesniku lijek ne pomaže.
English: What is Imlygic and what is it used for?
Croatian: Što je Imlygic i za što se koristi?
English: Other information about Imlygic
Croatian: Ostale informacije o lijeku Imlygic
English: The volume to be injected depends on the size of the tumour and the number of tumours to be injected.
Croatian: Volumen koji je potrebno ubrizgati ovisi o veličini tumora i broju tumora u koje je potrebno ubrizgati lijek.
English: Why is Imlygic approved?
Croatian: Zašto je Imlygic odobren?
English: The company has put in place a controlled distribution programme to qualified centres to ensure that the cold storage and handling requirements are observed and to control the distribution to the patients.
Croatian: Tvrtka je uspostavila program kontrolirane distribucije za kvalificirane centre kako bi se osiguralo ispunjavanje zahtjeva za čuvanje i rukovanje u hladnim uvjetima i distribucija lijeka do bolesnika.
English: Most of these side effects were mild or moderate in severity.
Croatian: Većina tih nuspojava bile su blage ili umjerene.
English: What measures are being taken to ensure the safe and effective use of Imlygic?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Imlygic?
English: This is a summary of the European public assessment report (EPAR) for Imlygic.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Imlygic.
English: Treatment with Imlygic should be started and given under the supervision of a doctor with expertise in the treatment of cancer.
Croatian: Liječenje lijekom Imlygic mora se započeti i provoditi pod nadzorom liječnika s iskustvom u liječenju raka.
English: When looking at the subset of patients in the study (249 patients) whose disease had not spread to the lung or other internal organs, 25% (41 out of 163) of patients treated with Imlygic had a sustained response to treatment, compared with around 1% (1 out of 86) of patients treated with GM-CSF.
Croatian: Gledajući podskupinu bolesnika koji su sudjelovali u ispitivanju (249 bolesnika) u kojih se bolest nije proširila na pluća ili druge unutarnje organe, 25 % (41 od 163) bolesnika liječenih lijekom Imlygic imalo je vidljiv održivi pozitivan rezultat u odnosu na otprilike 1 % (1 od 86) bolesnika liječenih proteinom GM-CSF.
English: This virus has been modified so it can infect and multiply inside melanoma cells.
Croatian: Taj je virus promijenjen kako bi mogao inficirati i razmnožavati se u stanicama melanoma.
English: It contains the active substance talimogene laherparepvec.
Croatian: Sadrži djelatnu tvar talimogen laherparepvec.
English: This protein stimulates the patient's immune system (the body's natural defences) to recognise and destroy melanoma cells.
Croatian: Taj protein potiče imunosni sustav bolesnika (prirodni obrambeni mehanizam tijela) da prepozna i uništi stanice melanoma.
English: Response to treatment was defined as reduction by at least 50% in the signs of melanoma.
Croatian: Određeno je da se pozitivnim rezultatom smatra smanjenje znakova melanoma za najmanje 50 %.
English: The main measure of effectiveness was the proportion of patients who responded to treatment and for whom the response lasted for at least six months before the patients' health declined or they required another therapy.
Croatian: Glavno mjerilo učinkovitosti bio je udio bolesnika koji su pozitivno reagirali na liječenje i u kojih je pozitivan rezultat trajao najmanje šest mjeseci prije narušavanja zdravlja ili prije nego što im je bila potrebna nova terapija.
English: In addition, Imlygic makes the infected melanoma cells produce a protein called GM-CSF.
Croatian: Osim toga, Imlygic djeluje tako da inficirane stanice melanoma proizvode protein koji se naziva GMCSF.
English: What are the risks associated with Imlygic?
Croatian: Koji su rizici povezani s lijekom Imlygic?
English: A risk management plan has been developed to ensure that Imlygic is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Imlygic.
English: The most common serious side effect (affecting around 2 in 100 people) was cellulitis (infection of the upper layers of the skin).
Croatian: Najčešća ozbiljna nuspojava (pojavila se u otprilike 2 na 100 osoba) bila je celulitis (upala gornjih slojeva kože).
English: Imlygic is available as a solution for injection in two different strengths.
Croatian: Imlygic je dostupan kao otopina za injekciju koja se daje u dvjema dozama različite jačine.
English: Although Imlygic can enter healthy cells, it is not designed to multiply inside them.
Croatian: Iako Imlygic može ući u zdrave stanice, nije napravljen tako da bi se u njima razmnožavao.
English: It is given as an injection into melanoma tumours.
Croatian: Daje se injekcijom u melanomske tumore.
English: Because Imlygic contains a herpes virus, it may reactivate at a later time causing herpes infections such as cold sores.
Croatian: Budući da lijek Imlygic sadrži virus herpes, on se može naknadno reaktivirati i uzrokovati herpesne infekcije kao što je groznica.
English: Imlygic is a type of advanced therapy medicine called a ‘gene therapy product'.
Croatian: Imlygic je vrsta lijeka za napredno liječenje koji se naziva „lijek za gensku terapiju”.
English: As part of this programme, the medicine will only be supplied to doctors who have received appropriate educational materials on the risk of herpes infection, particularly in patients with an impaired immune system, on the risk of transmission of the virus to healthcare professionals or other close contacts of the patient (accidental exposure), and on the necessary precautions to be taken when administering and disposing of the product.
Croatian: U okviru tog programa lijek će se dostavljati samo onim liječnicima koji su primili odgovarajuće edukativne materijale o riziku od herpesne infekcije, posebno u bolesnika s oslabljenim imunosnim sustavom, riziku od prenošenja virusa na zdravstvene djelatnike ili druge osobe koje su u bliskom kontaktu s bolesnikom (slučajna izloženost) te o mjerama opreza koje je potrebno poduzeti pri primjeni i odlaganju lijeka.
English: The company will also carry out three studies to further characterise the benefits and risks of Imlygic, including a study of Imlygic in patients with advanced melanoma that can be surgically removed.
Croatian: Tvrtka će također provesti tri ispitivanja kako bi dodatno opisala koristi i rizike lijeka Imlygic, uključujući ispitivanje lijeka Imlygic na bolesnicima s uznapredovalim melanomom koji se ne može kirurški odstraniti.
English: It is derived from a weakened herpes simplex virus 1 (the cold sore virus).
Croatian: Dobiva se iz oslabljenog virusa Herpes simplex tipa 1 (groznica ili herpes).
English: The most common side effects with Imlygic (which may affect more than 1 in 4 people) are tiredness, chills, pyrexia (fever), nausea (feeling sick), flu-like illness and pain at the injection site.
Croatian: Najčešće nuspojave lijeka Imlygic (mogu se javiti u više od 1 na 4 osobe) jesu umor, zimica, pireksija (vrućica), mučnina (osjećaj slabosti), bolest nalik na gripu i bol na mjestu injiciranja.
English: The study, which lasted 24 months, compared Imlygic with GM-CSF injected under the skin.
Croatian: Tijekom ispitivanja, koja je trajala 24 mjeseca, provedena je usporedba lijeka Imlygic s proteinom GMCSF ubrizganim pod kožu.
English: Patients will also be provided with educational materials and a patient alert card informing on the risks with the medicine and how to avoid accidental exposure to Imlygic.
Croatian: Bolesnicima će također biti osigurani edukativni materijali i bolesnička kartica upozorenja s informacijama o rizicima koje lijek nosi i o tome kako izbjeći slučajnu izloženost lijeku Imlygic.
English: The active substance in Imlygic, talimogene laherparepvec, is a type of gene therapy called ‘oncolytic virus'.
Croatian: Djelatna tvar u lijeku Imlygic, talimogen laherparepvec, vrsta je genske terapije koja se naziva „onkolitički virus”.
English: This is a type of medicine that works by delivering genes into the cells of the body.
Croatian: Riječ je o vrsti lijeka koja djeluje unosom gena u tijelo.
English: Imlygic must not be used in patients with a severely impaired immune system because if the virus gets reactivated, the herpes infection could spread to other parts of the body.
Croatian: Lijek Imlygic ne smije se primjenjivati u bolesnika s teško oslabljenim imunosnim sustavom jer se u slučaju reaktivacije virusa herpesna infekcija može proširiti na druge dijelove tijela.
English: In patients whose immune system is weak (e.g. patients with HIV), Imlygic may cause more widespread disease.
Croatian: U bolesnika sa slabim imunosnim sustavom (npr. bolesnika s virusom HIV) lijek Imlygic može uzrokovati bolest širih razmjera.
English: It is not intended to provide practical advice on how to use Imlygic.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Imlygic.
English: Regarding safety, Imlygic was relatively well tolerated and most side effects were mild or moderate in severity.
Croatian: U pogledu sigurnosti, pokazalo se da bolesnici relativno dobro podnose lijek Imlygic, a većina nuspojava bila je blaga ili umjerena.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) noted that Imlygic is a therapy with a novel mechanism of action which can be a valuable addition to existing therapies for advanced inoperable melanoma, an area of unmet medical need.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji ocijenio je da je lijek Imlygic terapija s novim mehanizmom djelovanja koji može biti vrijedna dopuna postojećim terapijama za napredne stadije melanoma koji se ne mogu kirurški odstraniti, odnosno u području medicinskih potreba koje nisu zadovoljene.
English: The first dose is given using the lower strength of Imlygic, but subsequent doses use the higher strength.
Croatian: Prvo se daje slabija doza lijeka Imlygic, a sljedeće su doze jače.
English: Thus, CHMP decided that Imlygic's benefits are greater than its risks and recommended that it be approved for use in the EU.
Croatian: Stoga je Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji zaključio da koristi od lijeka Imlygic nadmašuju s njim povezane rizike te je preporučio njegovo odobrenje za korištenje u Europskoj uniji.
English: For more information about treatment with Imlygic, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Imlygic pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
English: Patients with inoperable melanoma which had spread to other parts of the body (but not to bone, brain or lung) showed a prolonged reduction in their melanoma tumours when treated with Imlygic, although it is still not known whether this will translate into longer survival.
Croatian: U bolesnika s melanomom koji se ne može kirurški odstraniti i koji se proširio na druge dijelove tijela (ali ne na kosti, mozak ili pluća) vidljivo je dugotrajno smanjenje melanomskih tumora pri liječenju lijekom Imlygic, no i dalje nije poznato hoće li to dovesti do duljeg preživljenja.
English: Imlygic uses the melanoma cells' own machinery to multiply, eventually overwhelming melanoma cells and killing them.
Croatian: Imlygic koristi mehanizme samih stanica melanoma za razmnožavanje te ih s vremenom nadjača i uništi.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Imlygic, including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: Na temelju tog plana, u sažetku opisa svojstava lijeka kao i u uputi o lijeku za lijek Imlygic nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: Imlygic is a cancer medicine used to treat adults with melanoma (a type of skin cancer) that cannot be surgically removed and that has spread to other parts of the body (but not to bone, lung, brain and other internal organs).
Croatian: Imlygic je lijek za liječenje raka koji se primjenjuje u liječenju odraslih bolesnika s melanomom (vrsta raka kože) koji se ne može kirurški odstraniti i koji se proširio na druge dijelove tijela (ali ne na kosti, pluća, mozak i druge unutarnje organe).
English: Imlygic has been studied in one main study involving 436 patients with inoperable melanoma that had spread to other parts of the body (but not to bone and brain).
Croatian: Imlygic je ispitivan u jednom glavnom ispitivanju koje je obuhvatilo 436 bolesnika s melanomom koji se ne može kirurški odstraniti i koji se proširio na druge dijelove tijela (ali ne na kosti i mozak).
English: What benefits of Imlygic have been shown in studies?
Croatian: Koje su koristi lijeka Imlygic utvrđene u ispitivanjima?
English: For practical information about using Imlygic, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Imlygic pročitajte u uputi o lijeku ili se obratite svom liječniku ili ljekarniku.
English: How does Imlygic work?
Croatian: Kako djeluje Imlygic?
English: How is Imlygic used?
Croatian: Kako se Imlygic koristi?
English: For the full list of all side effects and restrictions reported with Imlygic, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja zabilježenih pri primjeni lijeka Imlygic potražite u uputi o lijeku.
English: 06 May 2019
Croatian: 6. svibnja 2019. godine
English: Stability
Croatian: Stabilnost
English: The clinical relevance of this finding is uncertain.
Croatian: Klinički značaj ovog nalaza nije jasan.
English: • if you have heart problems.
Croatian: • ako imate probleme sa srcem.
English: Patients 75 years and older
Croatian: Bolesnici u dobi od 75 i više godina
English: There were no differences in terminal half-lives.
Croatian: Nije bilo razlika u završnom poluvijeku.
English: The dose you receive is based on your body surface area and blood test results.
Croatian: Doza koju ćete primiti temelji se na površini Vašeg tijela i rezultatima krvnih pretraga.
English: How often will you receive Pazenir?
Croatian: Kako ćete često primati Pazenir?
English: The powder is white to yellow.
Croatian: Prašak je bijele do žute boje.
English: Neither freezing nor refrigeration adversely affects the stability of the product.
Croatian: Ni zamrzavanje ni hlađenje ne mogu negativno utjecati na stabilnost lijeka.