FrancophonIA/ELRC3.0 huggingface dataset:
English: This compared with over 9.5 months for patients who took encorafenib alone and just over 7 months for patients taking a different medicine called vemurafenib.
Croatian: To je usporedivo s više od 9,5 mjeseci za bolesnike koji su uzimali samo enkorafenib te s nešto više od 7 mjeseci za bolesnike koji su uzimali drugi lijek pod nazivom vemurafenib.
English: As for all medicines, data on the use of Mektovi are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Mektovi kontinuirano se prate.
English: An overview of Mektovi and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Mektovi i zašto je odobren u EU-u
English: The active substance in Mektovi, binimetinib, works by blocking MEK directly and by preventing its activation by BRAF thereby slowing down the growth and spread of the cancer.
Croatian: Djelatna tvar u lijeku Mektovi, binimetinib, djeluje na način da izravno blokira MEK i sprječava njegovu aktivaciju s pomoću BRAF-a, čime usporava rast i širenje raka.
English: Mektovi is a medicine for treating melanoma (a skin cancer) that has spread or cannot be removed by surgery.
Croatian: Mektovi je lijek za liječenje melanoma (raka kože) koji se proširio na druge dijelove tijela ili se ne može ukloniti kirurškim zahvatom.
English: Mektovi is used in combination with another medicine, encorafenib (Braftovi), and is only for patients whose cancer cells have a specific mutation (change) in their genes called 'BRAF V600'.
Croatian: Mektovi se koristi u kombinaciji s drugim lijekom, enkorafenibom (Braftovi), i koristi se samo u bolesnika čije stanice raka imaju određenu mutaciju (promjenu) u genima koja se naziva „BRAF V600”.
English: Mektovi in combination with encorafenib can help prolong the time these patients live without their disease getting worse.
Croatian: Mektovi u kombinaciji s enkorafenibom može pomoći u produljenju preživljenja tih bolesnika bez pogoršanja bolesti.
English: A study of 577 patients with melanoma with the BRAF V600 mutation that had spread or could not be removed surgically showed that Mektovi with encorafenib prolongs the length of time patients live without their disease getting worse.
Croatian: U okviru ispitivanja provedenog na 577 bolesnika oboljelih od melanoma s mutacijom BRAF V600 koji se proširio i ne može se ukloniti kirurškim putem utvrđeno je da lijek Mektovi u kombinaciji s enkorafenibom produljuje razdoblje preživljenja bolesnika bez pogoršanja bolesti.
English: Treatment with Mektovi can last for as long as the patient is benefiting from it and does not have unacceptable side effects.
Croatian: Liječenje lijekom Mektovi može trajati sve dok bolesnik ostvaruje koristi od liječenja i dok nema neprihvatljive nuspojave.
English: How does Mektovi work?
Croatian: Kako djeluje Mektovi?
English: What benefits of Mektovi have been shown in studies?
Croatian: Koje su koristi lijeka Mektovi utvrđene u ispitivanjima?
English: How is Mektovi used?
Croatian: Kako se Mektovi primjenjuje?
English: Pack size blister (PVC/PE/PVDC/alu)
Croatian: Oralna primjena blister (PVC/PE/PVDC/aluminij)
English: 30 mg Film-coated tablet Oral use
Croatian: 30 mg Filmom obložena tableta
English: Strength Pharmaceutical Form
Croatian: (Zaštićeno) ime Doza Farmaceutski oblik Put primjene Unutarnje pakovanje
English: Further information on Invirase can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Više informacija o lijeku Invirase nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This overview was last updated in 03-2018.
Croatian: Ovaj pregled informacija posljednji je put ažuriran u 3.2018.
English: What is Invirase and what is it used for?
Croatian: Što je Invirase i za što se koristi?
English: These studies measured the viral load after 48 weeks.
Croatian: U tim je ispitivanjima mjereno virusno opterećenje nakon 48 tjedana.
English: Invirase (saquinavir)
Croatian: Invirase (sakvinavir)
English: Invirase is available as capsules (200 mg) and tablets (500 mg).
Croatian: Invirase je dostupan u obliku kapsula (od 200 mg) i tableta (od 500 mg).
English: What measures are being taken to ensure the safe and effective use of Invirase?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Invirase?
English: This allows effective treatment while avoiding a higher dose of saquinavir.
Croatian: Time se omogućuje djelotvorno liječenje i ujedno izbjegava veća doza sakvinavira.
English: Why is Invirase authorised in the EU?
Croatian: Zašto je lijek Invirase odobren u EU-u?
English: What are the risks associated with Invirase?
Croatian: Koji su rizici povezani s lijekom Invirase?
English: Side effects reported with Invirase are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Invirase pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: It must not be used in patients who have had arrhythmia (unstable heartbeat).
Croatian: Ne smije se primjenjivati u bolesnika koji su imali aritmiju (nestabilni otkucaji srca).
English: When the enzyme is blocked, the virus does not reproduce normally, slowing down the spread of infection.
Croatian: Kada je taj enzim blokiran, virus se ne može normalno razmnožavati, što usporava širenje infekcije.
English: • medicines that could cause QT prolongation or PR prolongation (another type of heart activity alteration);
Croatian: • lijekove koji mogu uzrokovati prolongaciju QT-intervala ili prolongaciju PR-intervala (drugi oblik promjene rada srca);
English: Two further studies involving 656 patients compared Invirase with indinavir or lopinavir (other HIV medicines).
Croatian: U dvama dodatnim ispitivanjima koja su uključivala 656 bolesnika lijek Invirase uspoređen je s indinavirom ili lopinavirom (drugi lijekovi protiv HIV-a).
English: As for all medicines, data on the use of Invirase are continuously monitored.
Croatian: Kao za sve lijekove, podatci o primjeni lijeka Invirase kontinuirano se prate.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Invirase 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 Invirase nalaze se u sažetku opisa svojstava i u uputi o lijeku.
English: It slows the breakdown of saquinavir, increasing the levels of saquinavir in the blood.
Croatian: On usporava razgradnju sakvinavira i tako povećava razine sakvinavira u krvi.
English: It must also not be used in patients who are taking any of the following medicines which could cause harmful side effects if taken with Invirase:
Croatian: Ne smije se primjenjivati ni u bolesnika koji uzimaju bilo koji od sljedećih lijekova, a koji mogu uzrokovati opasne nuspojave ako se uzimaju u kombinaciji s lijekom Invirase:
English: • ergot alkaloids, such as ergotamine, dihydroergotamine, ergonovine and methylergonovine (used to treat migraine headache);
Croatian: • ergot alkaloide kao što su ergotamin, dihidroergotamin, ergonovin i metilergonovin (koji se koriste za liječenje migrene);
English: Invirase in combination with ritonavir was as effective as indinavir but more effective than lopinavir in reducing the viral load to less than 50 copies/ml.
Croatian: U kombinaciji s ritonavirom, Invirase je bio jednako djelotvoran kao indinavir, ali djelotvorniji od lopinavira u smanjenju virusnog opterećenja na manje od 50 kopija/ml.
English: Invirase is an antiviral medicine used to treat adults infected with the human immunodeficiency virus type 1 (HIV 1), a virus that causes acquired immune deficiency syndrome (AIDS).
Croatian: Invirase je antivirusni lijek koji se primjenjuje za liječenje odraslih osoba zaraženih virusom humane imunodeficijencije tipa 1 (HIV-1), virusom koji uzrokuje sindrom stečene imunodeficijencije (AIDS).
English: Invirase does not cure HIV infection or AIDS, but it may hold off the damage to the immune system and the development of infections and diseases associated with AIDS.
Croatian: Invirase ne liječi infekciju HIV-om niti AIDS, ali može odgoditi oštećenje imunosnog sustava te razvoj infekcija i bolesti povezanih s AIDS-om.
English: • rifampicin (used to treat tuberculosis);
Croatian: • rifampicin (koji se koristi za liječenje tuberkuloze);
English: Invirase received a marketing authorisation valid throughout the EU on 4 October 1996.
Croatian: Lijek Invirase dobio je odobrenje za stavljanje u promet koje vrijedi na prostoru EU-a od 4. listopada
English: The European Medicines Agency decided that Invirase's benefits are greater than its risks and it can be authorised for use in the EU.
Croatian: Europska agencija za lijekove zaključila je da koristi od lijeka Invirase nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u Europskoj uniji.
English: For more information about using Invirase, see the package leaflet or contact a doctor or pharmacist.
Croatian: Za više informacija o primjeni lijeka Invirase pogledajte uputu o lijeku, odnosno obratite se liječniku ili ljekarniku.
English: • midazolam taken by mouth, triazolam (used to relieve anxiety or difficulty sleeping);
Croatian: • midazolam koji se uzima na usta, triazolam (koji se koriste za ublažavanje anksioznosti ili poteškoća pri spavanju);
English: Ritonavir is another protease inhibitor that is used as a ‘booster'.
Croatian: Ritonavir je drugi inhibitor proteaze koji se koristi kao „pojačivač”.
English: Invirase must not be used in patients who have severe problems with their liver, QT prolongation (an alteration of the electrical activity of the heart), abnormal levels of electrolytes in the blood (especially low potassium levels), bradycardia (slow heart rate) or heart failure (when the heart does not work as well as it should).
Croatian: Lijek Invirase ne smije se primjenjivati u bolesnika koji imaju ozbiljnih problema s jetrom, prolongacijom QT-intervala (promjena električne aktivnosti srca), abnormalnim razinama elektrolita u krvi (osobito niskom razinom kalija), bradikardijom (spori otkucaji srca) ili srčanim zastojem (kada srce ne radi kako bi trebalo).
English: Invirase can only be obtained with a prescription and treatment should be started by a doctor who has experience in the treatment of HIV infection.
Croatian: Invirase se izdaje samo na liječnički recept, a liječenje mora započeti liječnik s iskustvom u liječenju infekcija HIV-om.
English: Invirase should only be used in combination with ritonavir (another antiviral medicine) and other antiviral medicines.
Croatian: Invirase se mora koristiti samo u kombinaciji s ritonavirom (drugi antivirusni lijek) i drugim antivirusnim lijekovima.
English: In the first four studies, Invirase in combination with other HIV medicines, but without ritonavir, reduced the viral load and improved the immune system.
Croatian: U prvim četirima ispitivanjima, kombinacija lijeka Invirase i drugih lijekova protiv HIV-a, ali bez ritonavira, smanjila je virusno opterećenje i poboljšala imunosni sustav.
English: The most common side effects when taking Invirase in combination with ritonavir (which may affect more than 1 patient in 10) are diarrhoea, nausea (feeling sick), increased levels of liver enzymes, cholesterol and triglycerides (a type of fat) in the blood, and decreased levels of platelets in the blood (components that help blood to clot).
Croatian: Najčešće nuspojave lijeka Invirase u kombinaciji s ritonavirom (koje se mogu javiti u više od 1 na 10 bolesnika) su proljev, mučnina (slabost), povećane razine jetrenih enzima, kolesterola i triglicerida (vrsta masti) u krvi i smanjene razine trombocita u krvi (sastavnice koje pomažu da se krv zgrušava).
English: The active substance in Invirase, saquinavir, is a ‘protease inhibitor'.
Croatian: Djelatna tvar u lijeku Invirase, sakvinavir, jest „inhibitor proteaze”.
English: It blocks protease, an enzyme involved in the reproduction of HIV.
Croatian: On blokira proteazu, enzim koji sudjeluje u razmnožavanju HIV-a.
English: • lurasidone, quetiapine (used to treat psychiatric illness such as schizophrenia).
Croatian: • lurasidon, kvetiapin (koji se koriste za liječenje psihijatrijskih bolesti kao što je shizofrenija).
English: Other information about Invirase
Croatian: Ostale informacije o lijeku Invirase
English: • simvastatin, lovastatin (used to lower cholesterol);
Croatian: • simvastatin, lovastatin (koji se koriste za smanjenje razine kolesterola);
English: Invirase contains the active substance saquinavir.
Croatian: Invirase sadrži djelatnu tvar sakvinavir.
English: What benefits of Invirase have been shown in studies?
Croatian: Koje su koristi od lijeka Invirase utvrđene u ispitivanjima?
English: The medicines were given in combination with ritonavir and two other HIV medicines.
Croatian: Lijekovi su primjenjivani u kombinaciji s ritonavirom i drugim dvama lijekovima protiv HIV-a.
English: For patients already taking HIV medicines, the recommended dose of Invirase is 1,000 mg with 100 mg ritonavir twice daily.
Croatian: Za bolesnike koji već uzimaju lijekove protiv HIV-a, preporučena doza lijeka Invirase jest 1000 mg uz 100 mg ritonavira dvaput dnevno.
English: How is Invirase used?
Croatian: Kako se Invirase koristi?
English: After 7 days, the recommended dose of Invirase is 1,000 mg twice daily with ritonavir 100 mg twice daily in combination with other HIV medicines.
Croatian: Nakon sedam dana, preporučena doza lijeka Invirase jest 1000 mg dvaput dnevno uz 100 mg ritonavira dvaput dnevno u kombinaciji s drugim lijekovima protiv HIV-a.
English: Invirase, taken in combination with other HIV medicines, reduces the viral load (the amount of HIV in the blood) and keeps it at a low level.
Croatian: Kada se uzima u kombinaciji s drugim lijekovima protiv HIV-a, Invirase smanjuje virusno opterećenje (koncentracija HIV-a u krvi) i održava ga na niskoj razini.
English: An overview of Invirase and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Invirase i razlozima njegova odobrenja u EU-u
English: For patients who are not taking HIV medicines, Invirase is started at 500 mg twice daily with ritonavir 100 mg twice daily for the first 7 days of treatment, given in combination with other HIV medicines.
Croatian: U bolesnika koji ne uzimaju lijekove protiv HIV-a, liječenje lijekom Invirase započinje dozom od 500 mg dvaput dnevno uz 100 mg ritonavira dvaput dnevno prvih sedam dana liječenja, u kombinaciji s drugim lijekovima protiv HIV-a.
English: How does Invirase work?
Croatian: Kako djeluje Invirase?
English: Invirase was found effective in the treatment of HIV infection in six main studies involving a total of 1,576 patients.
Croatian: U šest glavnih ispitivanja koja su uključivala ukupno 1576 bolesnika utvrđeno je da je lijek Invirase djelotvoran u liječenju infekcije HIV-om.
English: For the full list of side effects of Invirase, see the package leaflet.
Croatian: Potpuni popis nuspojava lijeka Invirase potražite u uputi o lijeku.
English: Do not try to drive.
Croatian: Ne pokušavajte voziti.
English: In children, this combination is not recommended.
Croatian: U djece se ova kombinacija ne preporučuje.
English: 36 months
Croatian: 36 mjeseci
English: † MedDRA version 13.1
Croatian: MedDRA verzija 13.1
English: Date of first authorisation: 31 March 2016
Croatian: Datum prvog odobrenja: 31. ožujka 2016.
English: IF ANY OF THE FOLLOWING OCCUR, THE CHILD NEEDS URGENT MEDICAL ATTENTION:
Croatian: AKO SE POJAVI BILO ŠTO OD SLJEDEĆEG, DJETETU JE POTREBNA HITNA LIJEČNIČKA POMOĆ:
English: OTHER SPECIAL WARNINGS, IF NECESSARY
Croatian: DRUGA POSEBNA UPOZORENJA (AKO JE POTREBNO)
English: Children and adolescents (5-18 years)
Croatian: Djeca i adolescenti (5 - 18 godina)
English: They occur during the first month of treatment and usually decrease with continued treatment.
Croatian: Događaju se tijekom prvog mjeseca liječenja i obično se smanjuju s nastavkom liječenja.
English: PC: SN:
Croatian: PC: SN: NN:
English: You may become sleepy and could lose consciousness.
Croatian: Mogli biste osjetiti pospanost i izgubiti svijest.
English: Absolute bioavailability is estimated to be approximately 100%.
Croatian: Procijenjena apsolutna bioraspoloživost iznosi približno 100%.
English: There is inadequate information to assess the relationship, if any, between dose and duration of treatment and these events.
Croatian: Nema odgovarajućih podataka da se procijeni odnos, ako postoji, između doze i trajanja liječenja i tih događaja.
English: Most reports occurred during periods of warm weather.
Croatian: Većina prijava bila je u razdobljima toplog vremena.
English: • Take the child to a cool, shaded place
Croatian: • Dijete sklonite na hladnije, sjenovito mjesto.
English: Additional information on special populations
Croatian: Dodatni podaci o posebnim populacijama
English: Steady state was achieved within 13 days.
Croatian: Stanje dinamičke ravnoteže postignuto je u roku od 13 dana.
English: Suicide ideation and behaviour
Croatian: Suicidalna ideacija i ponašanje
English: Tell your doctor as this may need to be monitored.
Croatian: Obavijestite svog liječnika jer to možda treba nadzirati.
English: All these effects and specifically weight loss may have deleterious implications for growth and development, and may lead to general deterioration of health.
Croatian: Svi ti učinci a posebice gubitak težine mogu imati štetne posljedice na rast i razvoj, i mogu dovesti do narušenog općeg zdravlja.
English: The mechanism of this risk is not known and the available data do not exclude the possibility of an increased risk for zonisamide.
Croatian: Mehanizam ovog rizika nije poznat, a dostupni podaci ne isključuju mogućnost povećanog rizika za zonisamid.
English: Main outcomes of this study are presented in this table:
Croatian: Glavni ishodi ispitivanja prikazani su u ovoj tablici:
English: Patients of weight > 55 kg
Croatian: Bolesnici težine > 55 kg
English: Titration Phase
Croatian: Faza titracije
English: Some patients may respond to lower doses.
Croatian: Neki bolesnici mogu odgovoriti na niže doze.
English: - Do not chew the capsules.
Croatian: - Kapsule nemojte žvakati.
English: Do not give this medicine to children below the age of 6 years because it is not known for this age group whether the potential benefits are greater than the risks.
Croatian: Ovaj lijek nemojte davati djeci mlađoj od 6 godina jer za tu dobnu skupinu nije poznato jesu li potencijalne koristi veće od rizika.
English: The dose should be titrated on the basis of clinical effect.
Croatian: Dozu treba titrirati na temelju kliničkog učinka.
English: You should not stop your treatment without discussing this with your doctor.
Croatian: Ne smijete prekinuti liječenje bez savjetovanja sa svojim liječnikom.
English: Zonisamide was not genotoxic and has no carcinogenic potential.
Croatian: Zonisamid nije bio genotoksičan i nema kancerogeni potencijal.
English: • Give the child cold water to drink
Croatian: • Dajte djetetu hladnu vodu za piće.
English: • Body weight: You should monitor your child's weight every month and see your doctor as soon as possible if your child is not gaining enough weight.
Croatian: • Tjelesna težina: morate mjeriti djetetovu tjelesnu težinu svaki mjesec i obratiti se liječniku što prije ako Vaše dijete ne dobiva na težini onoliko koliko bi trebalo.
English: Symptoms may occur within hours to weeks of initiating therapy.
Croatian: Simptomi se mogu pojaviti u roku od nekoliko sati do nekoliko tjedana od početka terapije.
English: In addition there has been extensive post-marketing experience with zonisamide in Japan since 1989 and in the USA since 2000.
Croatian: Osim toga, postoji opsežno iskustvo sa zonisamidom nakon stavljanja lijeka u promet i to u Japanu od 1989. te u Sjedinjenim Državama od 2000. godine.
English: No clinically significant differences were observed in the pharmacokinetics between young (aged 21-40 years) and elderly (65-75 years).
Croatian: Nisu primijećene klinički značajne razlike u farmakokinetici između mlađih (u dobi od 21 do 40 godina) i starijih osoba (od 65 do 75 godina).
English: Your doctor may need to monitor or treat this.
Croatian: To će liječnik možda morati nadzirati i liječiti.
English: Usual Maintenance Dose
Croatian: Uobičajena doza održavanja
English: - are pregnant or could become pregnant (see section ‘pregnancy, breast-feeding and fertility' for further information).
Croatian: - ako ste trudni ili biste mogli zatrudnjeti (pogledajte dio „Trudnoća, dojenje i plodnost” za više informacija).
English: If at any time you have these thoughts, immediately contact your doctor.
Croatian: Ako u bilo kojem trenutku imate takve misli, odmah se obratite liječniku.
English: - if you are allergic to other sulfonamide medicines.
Croatian: • alergični na druge sulfonamidne lijekove.
English: Children and adolescents Talk to your doctor about the following risks:
Croatian: Posavjetujte se s liječnikom zbog sljedećih rizika:
English: Note: * All doses are once daily.
Croatian: Napomena: * Sve doze odnose se na primjenu jedanput na dan.
English: The first-pass metabolism is believed to be negligible.
Croatian: Smatra se da je metabolizam prvog prolaza neznatan.
English: - Zonisamide Mylan can be taken once or twice daily, as instructed by your doctor.
Croatian: - Zonisamide Mylan se može uzimati jedanput ili dvaput na dan, prema uputama liječnika.
English: Subjects who were seizure-free for 26 weeks at a target dose level continued on this dose for another 26 weeks.
Croatian: Ispitanici koji uz ciljnu dozu nisu imali napadaj 26 tjedana, nastavili su uzimati tu dozu daljnjih 26 tjedana.
English: There is no evidence that zonisamide induces its own metabolism.
Croatian: Nema dokaza da zonisamid inducira vlastiti metabolizam.
English: Erythrocyte/plasma ratios are about 15 at low concentrations and about 3 at higher concentrations.
Croatian: Omjeri eritrociti/plazma iznose oko 15 pri niskim koncentracijama, a oko 3 pri višim koncentracijama.
English: • The child must drink plenty of cold water
Croatian: • mora piti mnogo hladne vode
English: - The recommended dose is 300 mg once a day.
Croatian: - Preporučena doza je 300 mg jedanput na dan.
English: Other medicines and Zonisamide Mylan Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
Croatian: Drugi lijekovi i Zonisamide Mylan Obavijestite svog liječnika ili ljekarnika ako uzimate, nedavno ste uzimali ili biste mogli uzimati bilo koje druge lijekove, uključujući i one koje ste nabavili bez recepta.
English: Altogether, data on effects on long-term growth and development are limited.
Croatian: Sveukupno, o učincima na dugoročni rast i razvoj postoje samo ograničeni podaci.
English: The incidence of a decrease in body weight of 10% or more was 10.7% (see section 4.4).
Croatian: Incidencija smanjenja tjelesne težine od 10% ili više iznosila je 10,7% (vidjeti dio 4.4).
English: Zonisamide may cause weight loss.
Croatian: Zonisamid može prouzročiti gubitak težine.
English: Parent drug and SMAP can additionally be glucuronidated.
Croatian: Osnovni lijek i SMAP mogu dodatno biti glukuronizirani.
English: Zonisamide has a long elimination half-life so its effects may be persistent.
Croatian: Zonisamid ima dugi poluvijek eliminacije pa njegovi učinci mogu biti trajni.
English: Studies in animals have shown changes in fertility parameters.
Croatian: Ispitivanja na životinjama pokazala su promjene u parametrima plodnosti.
English: At this higher dose level, juvenile rats showed a decrease in growth, learning, and developmental parameters.
Croatian: Pri takvoj višoj razini doze mladi štakori pokazivali su smanjenje parametara rasta, učenja i razvoja.
English: • with other antiepileptic medicines to treat seizures in adults, adolescents, and children aged 6 years and above.
Croatian: • s drugim lijekovima protiv epilepsije za liječenje napadaja u odraslih, adolescenata i djece u dobi od 6 i više godina.