FrancophonIA/ELRC3.0 huggingface dataset:
English: Passion flower is the common name for the above-ground parts of the plant Passiflora incarnata L. The HMPC conclusions only cover passion flower preparations which are obtained by comminuting (reducing into tiny pieces) or powdering the dried above-ground parts or as dry and liquid extracts.
Croatian: Zaključcima HMPC-a obuhvaćeni su samo pripravci pasiflorove zeleni koji su dobiveni usitnjavanjem (smanjivanjem na manje komadiće) ili usitnjavanjem suhih nadzemnih dijelova u prah ili u obliku suhih i tekućih ekstrakata.
English: In its assessment, the HMPC also considered published clinical studies of passion flower medicines.
Croatian: Prilikom svoje ocjene HMPC je razmotrio i objavljena klinička ispitivanja lijekova koji sadrže pasiflorovu zelen.
English: Therefore, the HMPC conclusions on the use of passion flower medicines are based on their long-standing use.
Croatian: Zaključci HMPC-a o primjeni lijekova koji sadrže pasiflorovu zelen stoga se temelje na njihovoj dugotrajnoj primjeni.
English: For practical information about using passion flower medicines, patients should read the package leaflet that comes with the medicine or contact their doctor or pharmacist.
Croatian: Za praktične informacije o primjeni lijekova koji sadrže pasiflorovu zelen bolesnici trebaju pročitati uputu o lijeku priloženu uz lijek, odnosno obratiti se svom liječniku ili ljekarniku.
English: Detailed instructions on how to take passion flower medicines and who can use them can be found in the package leaflet that comes with the medicine.
Croatian: lijekova koji sadrže pasiflorovu zelen i o tome tko ih smije uzimati navedene su u uputi o lijeku koja je priložena uz lijek.
English: What evidence supports the use of passion flower medicines?
Croatian: Kojim se dokazima potkrjepljuje primjena lijekova koji sadrže pasiflorovu zelen?
English: How are passion flower medicines approved in the EU?
Croatian: Kako se u EU-u odobravaju lijekovi koji sadrže pasiflorovu zelen?
English: To obtain a dry extract the solvent is then evaporated.
Croatian: Otapalo se zatim uparava kako bi se dobio suhi ekstrakt.
English: The main measure of effectiveness was the response to treatment after 16 weeks.
Croatian: Glavno mjerilo učinkovitosti bio je odgovor na liječenje nakon 16 tjedana.
English: This overview was last updated in 04-2018.
Croatian: Ovaj pregled informacija posljednji je put ažuriran u 4. 2018.
English: Further information of Targretin can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Više informacija o lijeku Targretin možete naći na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The response rates according to the 5 skin scores were 36% and 27%, respectively.
Croatian: Stope odgovora na temelju rezultata pet znakova na koži bile su 36 %, odnosno 27 %.
English: Targretin was not compared with another medicine.
Croatian: Targretin nije uspoređen s drugim lijekom.
English: Targretin (bexarotene) EMA/234177/2018
Croatian: Targretin (beksaroten) EMA/234177/2018
English: Targretin (bexarotene)
Croatian: Targretin (beksaroten)
English: Targretin is available as capsules (75 mg).
Croatian: Targretin je dostupan u obliku kapsula (75 mg).
English: The recommended starting dose is 300 mg/m2/day, taken as a single dose once a day with a meal.
Croatian: Preporučena je početna doza 300 mg/m2 na dan, a uzima se kao jednokratna doza jedanput na dan uz obrok.
English: Treatment should continue as long as the patient benefits from it.
Croatian: Liječenje treba trajati onoliko dugo koliko bolesnik ima koristi od liječenja.
English: Ninety-three of these patients had advanced disease that had not responded to other treatment.
Croatian: Ukupno 93 od tih bolesnika imalo je uznapredovalu bolest koja nije reagirala na drugi oblik liječenja.
English: The dose is adjusted depending on the patient's response to treatment or side effects.
Croatian: Doza se prilagođava ovisno o odgovoru bolesnika na liječenje ili nuspojavama.
English: What measures are being taken to ensure the safe and effective use of Targretin?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Targretin?
English: Other information about Targretin
Croatian: Ostale informacije o lijeku Targretin
English: Side effects reported with Targretin are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Targretin pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: Targretin must not be used in women who are pregnant or breast-feeding, or women who could become pregnant and who are not using effective contraception; patients who have had pancreatitis (inflammation of the pancreas); patients with uncontrolled hypercholesterolaemia (high blood cholesterol), hypertriglyceridaemia (high blood triglycerides [fat]) or thyroid disease; patients with hypervitaminosis A (high levels of vitamin A); patients with liver disease; patients with an ongoing body infection.
Croatian: Targretin se ne smije primjenjivati u žena koje su trudne ili doje ili žena u reproduktivnoj dobi koje ne koriste učinkovitu kontracepciju; bolesnika koji su imali pankreatitis (upala gušterače); bolesnika s nekontroliranom hiperkolesterolemijom (visoke razine kolesterola), nekontroliranom hipertrigliceridemijom (visoke razine triglicerida, vrste masnoća, u krvi) ili nekontroliranom bolešću štitnjače; bolesnika s hipervitaminozom A (visoke razine vitamina A); bolesnika s bolešću jetre; bolesnika s postojećom infekcijom.
English: The Agency recommended that Targretin be given marketing authorisation.
Croatian: Agencija je preporučila davanje odobrenja za stavljanje lijeka Targretin u promet.
English: What is Targretin and what is it used for?
Croatian: Što je Targretin i za što se koristi?
English: Targretin received a marketing authorisation valid throughout the EU on 29 March 2001.
Croatian: Lijek Targretin dobio je odobrenje za stavljanje lijeka u promet koje je na snazi u Europskoj uniji od 29. ožujka 2001.
English: An overview of Targretin and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Targretin i zašto je odobren u EU-u
English: For more information about using Targretin, see the package leaflet or contact your doctor or pharmacist.
Croatian: Za više informacija o primjeni lijeka Targretin pogledajte uputu o lijeku ili se obratite liječniku ili ljekarniku.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Targretin have been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Targretin nalaze se u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: CTCL is a rare type of lymphoma (cancer of the lymph tissue) where some white blood cells (T-cells) grow in the skin.
Croatian: CTCL je rijetka vrsta limfoma (rak limfnog sustava) pri kojemu određene bijele krvne stanice (T-stanice) rastu u koži.
English: The effectiveness of Targretin has been examined in two studies involving a total of 193 patients with CTCL who received at least two previous treatments.
Croatian: Učinkovitost lijeka Targretin ispitana je u dvama ispitivanjima koja su obuhvatila ukupno 193 bolesnika s CTCL-om koji su prethodno primili najmanje dva liječenja.
English: As for all medicines, data on the use of Targretin are continuously monitored.
Croatian: Kao za sve lijekove, podaci o primjeni lijeka Targretin kontinuirano se prate.
English: grading of improvement, as well as by a score of 5 clinical signs (area of skin affected, redness, raised areas, scale-like skin and colour).
Croatian: To je mjereno liječničkom ocjenom poboljšanja i rezultatom pet kliničkih znakova (zahvaćeno područje kože, crvenilo, izdignuta područja kože, ljuskavost i boja kože).
English: Why is Targretin authorised in the EU?
Croatian: Zašto je lijek Targretin odobren u EU-u?
English: The most common side effects with Targretin (which may affect more than 1 patient in 10) are leucopenia (reduced white cell count), hypothyroidism (underactive thyroid gland), hyperlipaemia (high levels of fats in the blood), hypercholesterolaemia (high blood cholesterol), exfoliative dermatitis (skin peeling), pruritus (itching), rash, pain, headache and weakness.
Croatian: Najčešće su nuspojave lijeka Targretin (koje se mogu javiti u više od 1 na 10 osoba) leukopenija (smanjen broj bijelih krvnih stanica), hipotireoza (nedovoljno aktivna štitnjača), hiperlipemija (visoka razina masnoće u krvi), hiperkolesterolemija (visoke razine kolesterola), eksfolijativni dermatitis (ljuštenje kože), pruritus (svrbež), osip, bol, glavobolja i slabost.
English: What are the risks associated with Targretin?
Croatian: Koji su rizici povezani s lijekom Targretin?
English: Targretin can only be obtained with a prescription and treatment should only be initiated and maintained by a doctor who has experience in the treatment of patients with CTCL.
Croatian: Lijek Targretin izdaje se samo na liječnički recept, a liječenje smije započeti i nadzirati samo liječnik s iskustvom u liječenju bolesnika s CTCL-om.
English: Targretin is a cancer medicine used for the treatment of the visible signs on the skin of cutaneous Tcell lymphoma (CTCL).
Croatian: Targretin je lijek protiv raka koji se primjenjuje za liječenje vidljivih znakova kožnog limfoma T-stanica (CTCL) na koži.
English: Targretin is used in patients who have an advanced disease and have had at least one other treatment.
Croatian: Targretin se primjenjuje u bolesnika s uznapredovalom bolešću koji su prethodno primili barem jedan drugi oblik liječenja.
English: The dose of Targretin is based on the patient's body surface area in square metres (m2).
Croatian: Doza lijeka Targretin temelji se na kvadratnom metru (m2) tjelesne površine bolesnika.
English: The European Medicines Agency decided that Targretin's benefits are greater than its risks for the treatment of the skin manifestations of advanced-stage CTCL patients refractory to at least one treatment.
Croatian: Europska agencija za lijekove zaključila je da koristi lijeka Targretin nadmašuju s njim povezane rizike u liječenju bolesnika s manifestacijama uznapredovalog CTCL-a na koži koji se pokazao otpornim na barem jedno liječenje.
English: Across the two studies, among the patients who received 300 mg/m2, about half of them responded to treatment, according the doctor's grading.
Croatian: Promatrajući oba ispitivanja, u skladu s ocjenom liječnika zabilježen je odgovor na liječenje u otprilike polovice bolesnika koji su primili dozu od 300 mg/m2.
English: How does Targretin work?
Croatian: Kako djeluje Targretin?
English: What benefit of Targretin have been shown in studies?
Croatian: Koje su koristi lijeka Targretin dokazane u ispitivanjima?
English: How is Targretin used?
Croatian: Kako se Targretin koristi?
English: The active substance in Targretin, bexarotene, belongs to the group of retinoids, substances that are derived from vitamin A. The exact way bexarotene works in CTCL is not known.
Croatian: Djelatna tvar u lijeku Targretin, beksaroten, pripada skupini retinoida, tvari dobivenih iz vitamina A.
English: For the full list of side effects reported with Targretin, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Targretin potražite u uputi o lijeku.
English: Sixty-one patients were treated at the starting dose of 300 mg/m2/day.
Croatian: Početna doza od 300 mg/m2 na dan primijenjena je u 61 bolesnika.
English: This summary was last updated in 01-2014.
Croatian: Sažetak je posljednji put ažuriran 01-2014.
English: This is a type of epilepsy where too much electrical activity in one side of the brain causes symptoms such as sudden, jerky movements of one side of the body, distorted hearing, sense of smell or vision, numbness, or a sudden sense of fear.
Croatian: Ovo je tip epilepsije kada prevelika električna aktivnost u jednoj strani mozga uzrokuje simptome poput iznenadnih trzaja jedne strane tijela, oštećenje sluha, osjeta mirisa ili vida, tupost ili iznenadan osjećaj straha.
English: Secondary generalisation occurs when the overactivity later reaches the whole brain.
Croatian: Sekundarna generalizacija nastupa kada prekomjerna aktivnost kasnije zahvati cijeli mozak.
English: The exact way in which levetiracetam works is still unclear but it seems to interfere with a protein called synaptic vesicle protein 2A, which is found in the spaces between nerves and is involved in the release of chemical messengers from nerve cells.
Croatian: Još uvijek nije jasan točan način djelovanja levetiracetama, no čini se da interferira s proteinom naziva sinaptički vezikularni protein 2A, koji se nalazi u prostoru između živaca te je uključen u otpuštanje kemijskih glasnika iz živčanih stanica.
English: Epilepsy is caused by excessive electrical activity in the brain.
Croatian: Epilepsiju uzrokuje prekomjerna električna aktivnost u mozgu.
English: The full EPAR for Levetiracetam Hospira can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjelovito Europsko javno izvješće o ocjeni dokumentacije o lijeku (EPAR) za Levetiracetam Hospira nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: What is Levetiracetam Hospira and what is it used for?
Croatian: Što je Levetiracetam Hospira i za što se koristi?
English: This helps Levetiracetam Hospira to stabilise electrical activity in the brain and prevent seizures.
Croatian: Ovo pomaže lijeku Levetiracetam Hospira da stabilizira električnu aktivnost u mozgu i spriječi napadaje.
English: • primary generalised tonic-clonic seizures (major fits, including loss of consciousness) in patients from 12 years of age with idiopathic generalised epilepsy (the type of epilepsy that is thought to have a genetic cause).
Croatian: • primarno generaliziranih toničko-kloničkih napadaja (veliki napadaji, uključujući gubitak svijesti) u bolesnika starijih od 12 godina s idiopatskom generaliziranom epilepsijom (tipom epilepsije za koju se misli da ima genetski uzrok).
English: The company provided data from the published literature on levetiracetam.
Croatian: Društvo je dostavilo podatke iz objavljene literature o levetiracetamu.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Levetiracetam Hospira on the 08 January 2014.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje za lijek Levetiracetam Hospira vrijedi na prostoru Europske unije od 08. siječnja 2014.
English: It is not intended to provide practical advice on how to use Levetiracetam Hospira.
Croatian: Svrha sažetka nije davati praktične savjete o korištenju lijeka Levetiracetam Hospira.
English: • myoclonic seizures (short, shock-like jerks of a muscle or a group of muscles) in patients from 12 years of age with juvenile myoclonic epilepsy;
Croatian: • miokloničkih napadaja (kratkih trzaja sličnih strujnom udaru mišića ili grupe mišića) u bolesnika starijih od 12 godina s juvenilnom miokloničkom epilepsijom;
English: Levetiracetam Hospira can also be used as an add-on to other anti-epileptic medicines to treat:
Croatian: Levetiracetam Hospira može se također koristi kao dodatak drugim antiepilepticima u liječenju:
English: This means that Levetiracetam Hospira is similar to a ‘reference medicine' already authorised in the European Union (EU) called Keppra.
Croatian: To znači da je Levetiracetam Hospira sličan „referentnom lijeku” koji je već odobren u Europskoj uniji pod nazivom Keppra.
English: In patients aged between four and 17 years weighing less than 50 kg, the starting dose is 10 mg per kilogram body weight twice a day, which can be increased up to 30 mg/kg twice a day.
Croatian: U bolesnika u dobi između četiri i 17 godina tjelesne težine manje od 50 kg, početna doza iznosi 10 mg po kilogramu tjelesne težine dva puta na dan, te se može povećati do 30 mg/kg dva puta na dan.
English: Levetiracetam Hospira can only be obtained with a prescription and is available as a concentrate (100 mg/ml) that is made up into a solution for infusion (drip) into a vein.
Croatian: Levetiracetam Hospira se izdaje samo na liječnički recept i dostupan je kao koncentrat (100 mg/ml) za otopinu za infuziju (drip) u venu.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Levetiracetam Hospira has been shown to have comparable quality and to be bioequivalent to Keppra.
Croatian: Povjerenstvo za lijekove za primjenu kod ljudi (CHMP) pri Agenciji zaključilo je kako je, u skladu s preduvjetima EU-a, potvrđeno kako Levetiracetam Hospira posjeduje usporedivu kvalitetu te je bioekvivalentan s lijekom Keppra.
English: Lower doses are used in patients who have reduced kidney function.
Croatian: Slabije doze koriste se u bolesnika s oštećenom funkcijom bubrega.
English: What measures are being taken to ensure the safe and effective use of Levetiracetam Hospira?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Levetiracetam Hospira?
English: Levetiracetam Hospira is a ‘generic medicine'.
Croatian: Levetiracetam Hospira je „generički lijek”.
English: • partial-onset seizures with or without generalisation in patients from four years of age;
Croatian: • parcijalnih napadaja sa sekundarnom generalizacijom ili bez nje u bolesnika s epilepsijom starijih od 4 godine;
English: A risk management plan has been developed to ensure that Levetiracetam Hospira is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Levetiracetam Hospira.
English: This is a summary of the European public assessment report (EPAR) for Levetiracetam Hospira.
Croatian: Ovo je sažetak Europskoga javnog izvješća o ocjeni dokumentacije o lijeku (EPAR) za lijek Levetiracetam Hospira.
English: Because Levetiracetam Hospira is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Croatian: Budući da je Levetiracetam Hospira generički lijek te je bioekvivalent referentnom lijeku, smatra se da su njegove koristi i rizici isti kao i oni referentnog lijeka.
English: The daily dose can be increased up to 1,500 mg twice a day.
Croatian: Dnevna se doza može povećati do 1 500 mg dva puta na dan.
English: Other information about Levetiracetam Hospira
Croatian: Ostale informacije o lijeku Levetiracetam Hospira
English: No additional studies were needed as Levetiracetam Hospira is a generic medicine that is given by infusion and contains the same active substance as the reference medicine, Keppra.
Croatian: Dodatna ispitivanja nisu bila potrebna zato što je Levetiracetam Hospira generički lijek koji se primjenjuje infuzijom i sadrži istu djelatnu tvar kao referentni lijek Keppra.
English: What are the benefits and risks of Levetiracetam Hospira?
Croatian: Koje su koristi i rizici lijeka Levetiracetam Hospira?
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Levetiracetam Hospira, including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: Na temelju tog plana u sažetak opisa svojstava lijeka kao i u uputu o lijeku za Levetiracetam Hospira uključene su sigurnosne informacije, uključujući odgovarajuće mjere opreza koje zdravstveni djelatnici i bolesnici trebaju primjenjivati.
English: For more information about treatment with Levetiracetam Hospira, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Levetiracetam Hospira pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svom liječniku ili ljekarniku.
English: When Levetiracetam Hospira is added to another anti-epileptic treatment, the starting dose in patients over 12 years weighing 50 kg or more is 500 mg twice a day.
Croatian: Ako se Levetiracetam Hospira dodaje drugoj terapiji protiv epilepsije, početna terapijska doza u bolesnika starijih od 12 godina tjelesne težine 50 kg ili više iznosi 500 mg dva puta na dan.
English: The Committee recommended that Levetiracetam Hospira be approved for use in the EU.
Croatian: Povjerenstvo je preporučilo izdavanje odobrenja za stavljanje u promet lijeka Levetiracetam Hospira u EU-u.
English: The active substance in Levetiracetam Hospira, levetiracetam, is an anti-epileptic medicine.
Croatian: Djelatna tvar u lijeku Levetiracetam Hospira, levetiracetam, je antiepileptik.
English: Levetiracetam Hospira is an anti-epileptic medicine that contains the active substance levetiracetam.
Croatian: Levetiracetam Hospira je antiepileptik koji sadrži djelatnu tvar levetiracetam.
English: Why is Levetiracetam Hospira approved?
Croatian: Zašto je lijek Levetiracetam Hospira odobren?
English: For practical information about using Levetiracetam Hospira, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o korištenju lijeka Levetiracetam Hospira pročitajte u uputi o lijeku, odnosno obratite se svom liječniku ili ljekarniku.
English: When Levetiracetam Hospira is used on its own, the starting dose is 250 mg twice a day, increasing two weeks later to 500 mg twice a day.
Croatian: Ako se Levetiracetam Hospira koristi kao monoterapija, početna doza je 250 mg dva puta na dan, koju nakon dva tjedna treba povećati do inicijalne terapijske doze od 500 mg dva puta na dan.
English: Levetiracetam Hospira infusion should only be used temporarily, while treatment by mouth is not feasible.
Croatian: Infuzija lijeka Levetiracetam Hospira treba se koristiti samo privremeno.
English: How is Levetiracetam Hospira used?
Croatian: Kako se Levetiracetam Hospira koristi?
English: It can be used on its own in patients from 16 years of age with newly diagnosed epilepsy, to treat partialonset seizures (fits) with or without secondary generalisation.
Croatian: Može se koristiti kao monoterapija za liječenje parcijalnih napadaja sa sekundarnom generalizacijom ili bez nje u bolesnika starijih od 16 godina s novodijagnosticiranom epilepsijom.
English: Therefore, the CHMP's view was that, as for Keppra, the benefit outweighs the identified risk.
Croatian: Stoga je stav Povjerenstva kako koristi nadmašuju utvrđene rizike, kao i kod lijeka Keppra.
English: The dose can be further increased at two-week intervals according to the patient's response, to a maximum dose of 1,500 mg twice a day.
Croatian: Doza se može dalje povećavati svaka dva tjedna, ovisno o kliničkom odgovoru bolesnika.
English: How has Levetiracetam Hospira been studied?
Croatian: Kako se Levetiracetam Hospira ispitivao?
English: The medicine is used in:
Croatian: Lijek se primjenjuje:
English: Further information on Myalepta can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Više informacija o lijeku Myalepta nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Myalepta has been authorised under ‘exceptional circumstances'.
Croatian: Lijek Myalepta je odobren u „iznimnim okolnostima”.
English: It also results in insulin resistance (when the body is unable to recognise insulin, a hormone that helps regulate blood sugar levels).
Croatian: Također dovodi do otpornosti na inzulin (tijelo ne može prepoznati inzulin, hormon koji pomaže u regulaciji razine šećera u krvi).
English: The recommended daily dose depends on the patient's bodyweight and is adjusted based on the patient's response to treatment.
Croatian: Preporučena dnevna doza ovisi o tjelesnoj težini bolesnika te se prilagođava na temelju odgovora bolesnika na liječenje.
English: However, the medicine does not restore fat tissue under the skin.
Croatian: No, ovaj lijek ne obnavlja potkožnu masnoću.