natgillin/translations-raw huggingface dataset:
The company presented the results of two main studies involving a total of 20 children with urea cycle disorders in which the effects of Heparesc were compared with historical results in children who had not received Heparesc treatment.
Tvrtka je iznijela rezultate dvaju glavnih ispitivanja koja su uključivala ukupno 20-ero djece s poremećajima ciklusa ureje u kojima su učinci lijeka Heparesc uspoređeni s prošlim rezultatima u djece koja nisu primila terapiju lijekom Heparesc.
How is Heparesc expected to work?
Kako je Heparesc trebao djelovati?
Heparesc was developed as a type of advanced therapy medicine called a ‘somatic cell therapy product'.
Heparesc je razvijen kao vrsta lijeka za naprednu terapiju koji se naziva „lijek za terapiju somatskim stanicama”.
Because Heparesc is an advanced therapy medicine, it was assessed by the Committee for Advanced Therapies (CAT).
Budući da je Heparesc lijek za naprednu terapiju, ocijenio ga je Odbor za napredne terapije (CAT).
Heparesc is a medicine that contains living cells from the liver of a healthy donor which have been manipulated and then frozen for long-term storage.
Heparesc je lijek koji sadrži žive stanice jetre zdravog darivatelja koje su izmijenjene, a zatim zamrznute za dugoročnu pohranu.
The company that applied for authorisation is Cytonet GmbH & Ci KG.
Tvrtka Cytonet GmbH & Ci KG podnijela je zahtjev za izdavanje odobrenja.
Both Committees confirmed their opinion that the effectiveness of Heparesc in the treatment of these disorders had not been sufficiently demonstrated.
Oba su odbora potvrdila svoje mišljenje prema kojemu učinkovitost lijeka Heparesc u liječenju tih poremećaja nije bila prikazana na zadovoljavajući način.
In addition, the CHMP had concerns about the clinical relevance of the results of the tests that measured the ability to produce urea.
Osim toga, CHMP je izrazio zabrinutost u vezi s kliničkom važnošću rezultata ispitivanja kojima se mjerila sposobnost proizvodnje ureje.
What was Heparesc expected to be used for?
Za što se Heparesc trebao koristiti?
During the re-examination the CAT and CHMP looked again at the data from the company, and also consulted experts in the treatment of urea cycle disorders.
CAT i CHMP su tijekom ponovnog ispitivanja još jedanput pregledali podatke tvrtke i savjetovali se sa stručnjacima u liječenju poremećaja ciklusa ureje.
The company informed the CHMP that the refusal had no consequences for patients in clinical trials or compassionate use programmes.
Tvrtka je obavijestila CHMP da odbijanje nema posljedica za bolesnike koji su uključeni u klinička ispitivanja ili u programe milosrdnog davanja lijeka.
These are rare inborn conditions in which the liver does not produce particular enzymes involved in removing nitrogen from the body via a substance called urea.
Riječ je o rijetkim prirođenim stanjima u kojima jetra ne proizvodi određene enzime uključene u uklanjanje dušika iz tijela s pomoću tvari koja se naziva ureja.
The Committee thus considered that the benefits of treatment had not been sufficiently demonstrated.
Odbor je stoga razmotrio mogućnost toga da koristi od liječenja nisu prikazane na zadovoljavajući način.
When the medicine is injected into the portal vein leading to the liver, some of the liver cells it contains are expected to settle in the recipient's liver and start producing the missing liver enzyme, thus helping to reduce the symptoms of the disease.
Kada se lijek unosi u portalnu venu koja vodi do jetre, pojedine stanice jetre koje lijek sadrži trebaju se nastaniti u jetri primatelja i početi proizvoditi enzim jetre koji nedostaje, te na taj način pomoći u smanjenju simptoma bolesti.
The medicine was to be given by slow injection through a tube inserted by a surgical procedure into the portal vein (a vein leading directly to the patient's liver).
Lijek se trebao davati postupnom injekcijom kroz cjevčicu koja se operativnim zahvatom ugrađuje u portalnu venu (venu koja vodi izravno do jetre bolesnika).
Heparesc is made of liver cells from an organ donor who can produce the enzyme that is missing in patients with urea cycle disorders.
Heparesc se proizvodi od stanica jetre darivatelja organa koji može proizvoditi enzim koji nedostaje u bolesnika s poremećajima ciklusa ureje.
Heparesc was intended to help temporary management of these conditions in children until they are big enough to be given a liver transplant to cure them.
Heparesc se trebao koristiti za privremeno liječenje tih stanja u djece dok dovoljno ne odrastu za transplantaciju jetre u svrhu izlječenja.
The CHMP had concerns about the design and conduct of the studies, which cast doubt on their results and whether these could have occurred by chance.
CHMP je izrazio zabrinutost u vezi s nacrtom i provođenjem ispitivanja, čime su dovedeni u pitanje rezultati ispitivanja te je navedena mogućnost da se do njih došlo slučajno.
Taking into account the assessments performed by the CAT, the CHMP concluded that Heparesc could not be approved for the treatment of children with urea cycle disorders.
Uzevši u obzir ocjenjivanja koja je proveo CAT, CHMP je zaključio da se Heparesc ne može odobriti za liječenje djece s poremećajima ciklusa ureje.
Heparesc was to be used for the treatment of children from birth up to 3 years of age with specific urea cycle disorders.
Heparesc se trebao koristiti za liječenje djece od u dobi od rođenja do 3 godine koja imaju određene poremećaje ciklusa ureje.
Although taking into account the challenges of developing the medicine, including the difficulty of enrolling patients due to the rarity of the disease, the CHMP therefore concluded that the benefits of Heparesc did not outweigh its risks and maintained the previous recommendation that the medicine be refused marketing authorisation.
Premda je razmotrio izazove u pogledu razvijanja lijeka, uz teškoće u pogledu uključivanja bolesnika zbog rijetkosti bolesti, CHMP je zaključio kako koristi od lijeka Heparesc ne nadmašuju s njime povezane rizike te je zadržao prethodnu preporuku da se odbije izdavanje odobrenja za stavljanje lijeka u promet.
Therefore, at the time of the initial evaluation, the CHMP was of the opinion that the benefits of Heparesc did not outweigh its risks and recommended that it be refused marketing authorisation.
Stoga je u vrijeme početnog ocjenjivanja CHMP smatrao da koristi od lijeka Heparesc ne nadmašuju s njime povezane rizike te je preporučio da se odbije izdavanje odobrenja za stavljanje lijeka u promet.
The specific urea cycle disorders for which Heparesc was intended to be used are called carbamoylphosphate synthetase 1 deficiency, ornithine transcarbamylase deficiency, argininosuccinate synthetase deficiency (citrullinaemia type 1), argininosuccinate lyase deficiency (argininosuccinic aciduria) and arginase deficiency (hyperargininaemia).
Određeni poremećaji ciklusa ureje za koje je Heparesc namijenjen nazivaju se nedostatak karbamilfosfat sintetaze I., nedostatak ornitin-transkarbamilaze, nedostatak argininosukcinat-sintetaze
Week 96
96.tjedan
- This medicine has been prescribed for you or your child only.
Ovaj je lijek propisan samo Vama ili Vašem djetetu.
Stevens-Johnson syndrome, erythema multiforme
Stevens-Johnsonov sindrom, erythema multiforme
Other forms of this medicine may be more suitable for children; ask your doctor or pharmacist.
Drugi oblici ovog lijeka mogu biti prikladniji za djecu; pitajte svog liječnika ili ljekarnika.
This leaflet was last revised in .
Ova uputa je zadnji puta revidirana u:
− Continue to take this medicine until your doctor tells you otherwise.
Uzimajte ovaj lijek dok Vam liječnik ne kaže suprotno.
− If you cannot contact your doctor, go to the hospital.
Ako ne možete obavijestiti svog liječnika, javite se u bolnicu.
Mylan SAS 117 Allee des Parcs 69800 Saint-Priest France
Mylan SAS 117 Allee des Parcs 69800 Saint-Priest Francuska
If the condition persists or worsens, seek medical attention.
Ukoliko simptomi potraju ili se pogoršaju, potražite medicinsku pomoć.
− For children, your doctor will decide the right dose (number of tablets) based on the child's height and weight.
Liječnik će odlučiti o odgovarajućoj dozi (broju tableta) za dijete, na temelju djetetove težine i visine.
Effects on the electrocardiogram
Utjecaj na elektrokardiogram
Animal studies have shown no effects on fertility.
Ispitivanja na životinjama pokazala su da nema učinaka na plodnost.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1000 to < 1/100) and not known (cannot be estimated from the available data).
Unutar svake grupe učestalosti nuspojave su prikazane u padajućem nizu prema ozbiljnosti: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100) i nepoznato (ne može se procjeniti iz dostupnih podataka).
For plastic containers, use within 120 days after first opening.
Za plastične spremnike, iskoristiti u roku od 120 dana nakon prvog otvaranja.
HCV protease inhibitors Boceprevir 800 mg three times daily
HCV inhibitori proteaza Boceprevir 800 mg tri puta na dan
1 See section 4.4: pancreatitis and lipids c.
1 Vidjeti dio 4.4: pankreatitis i lipidi c.
Patients should be closely monitored for signs related to venetoclax toxicities.
Bolesnike treba pomno pratiti zbog znakova povezanih s toksičnošću venetoklaksa.
Virologic Response of Study Subjects at Week 48 Study 802 QD
Virološki odgovor ispitanika u 48. tjednu studije 802 QD
The 16 viruses that displayed > 20-fold change in susceptibility all contained mutations at positions 10, 54, 63 plus 82 and/or 84.
Svih 16 virusa koji su pokazali > 20 puta promjenu u osjetljivosti sadržavalo je mutacije na položajima 10, 54, 63 plus 82 i/ili 84.
− You can still pass on HIV when taking this medicine, although the risk is lowered by effective antiretroviral therapy.
HIV virus možete prenijeti čak i dok uzimate ovaj lijek, iako je tada rizik od prijenosa manji zbog učinkovite antiretrovirusne terapije.
Conclusions regarding the relevance of particular mutations or mutational patterns are subject to change with additional data, and it is recommended to always consult current interpretation systems for analysing resistance test results.
Zaključci o nekoj mutaciji ili mutacijskom uzorku mijenjaju se s pojavom dodatnih podataka i preporučuje se uvijek u analizi rezultata testa rezistencije konzultirati sustav interpretacije koji je u tom trenutku u uporabi.
For storage conditions after first opening of the medicinal product, see section 6.3.
Za uvjete čuvanja nakon otvaranja lijeka pogledajte dio 6.3.
The safety and efficacy of lopinavir/ritonavir in children aged less than 2 years have not yet been established.
Sigurnost i djelotvornost lopinavira/ritonavira u djece mlađe od dvije godine nisu još ustanovljene.
Lack of resistance to lopinavir was confirmed by phenotypic analysis.
Izostanak rezistencije na lopinavir je potvrđen fenotipskom analizom.
Patients were administered either the tablet or the soft capsule formulation for 8 weeks, after which all patients were administered the tablet formulation once daily or twice daily for the remainder of the study.
Bolesnicima je davana ili formulacija tableta ili formulacija mekih kapsula kroz 8 tjedana, nakon čega je svim bolesnicima davana samo formulacija tableta jednom dnevno ili dva puta dnevno u preostalom djelu studije.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 14 January 2016
Datum prvog odobrenja: 14 Siječanj 2016
* n = 18 for Cmax ** n = 16 for Cpredose
* n = 18 for Cmax
The increased digoxin level may lessen over time as Pgp induction develops.
Povećana razina digoksina može se s vremenom smanjiti kako se razvija indukcija Pgp-a.
Telaprevir 750 mg three times daily
Telaprevir 750 mg tri puta na dan
BSA (m2) = √ (Height (cm) X Weight (kg) / 3600)
PT (m2) =  (visina (cm) X težina (kg) / 3600)
It should be kept in mind that the twice weekly dosage of 150 mg may not provide an optimal exposure to rifabutin thus leading to a risk of rifamycin resistance and a treatment failure.
Mora se imati na umu da doza od 150 mg dvaput na tjedan ne može omogućiti optimalnu izloženost rifabutinu što može voditi do rezistencije na rifampicin i neuspjeha terapije.
Maximum PR interval was 286 ms and no second or third degree heart block was observed (see section 4.4).
Najveći PR interval bio je 286 msec, a srčani blok drugog ili trećeg stupnja nije primijećen (vidjeti dio 4.4).
As a general rule, when deciding to use antiretroviral agents for the treatment of HIV infection in pregnant women and consequently for reducing the risk of HIV vertical transmission to the newborn, the animal data as well as the clinical experience in pregnant women should be taken into account in order to characterise the safety for the foetus.
Kao opće pravilo, kada se odluči za uporabu antiretrovirusnih lijekova za liječenje HIV infekcije kod trudnih žena i posljedično smanjenje rizika vertikalnog prijenosa HIV-a na novorođenče, moraju se uzeti u obzir podaci dobiveni kod životinja kao i klinička iskustva kod trudnica kako bi se utvrdila sigurnost za fetus.
Lopinavir/ritonavir may cause changes in your heart rhythm and the electrical activity of your heart.
Lopinavir/ritonavir može uzrokovati promjene u Vašem srčanom ritmu i u električnoj aktivnosti srca.
Lopinavir is an inhibitor of the HIV-1 and HIV-2 proteases.
Lopinavir je inhibitor HIV 1 i HIV 2 proteaza.
The prevalence of birth defects after any trimester exposure to lopinavir is comparable to the prevalence observed in the general population.
Prevalencija kongenitalnih oštećenja nakon izloženosti lopinaviru u bilo kojem tromjesečju je usporediva prevalenciji zabilježenoj kod opće populacije.
Treatment emergent adverse events led to premature study discontinuation for 7% of subjects from Phase II-IV studies.
Liječenje hitnih štetnih događaja vodilo je prema preuranjenom obustavljanju ispitivanja faza II-IV kod 7% bolesnika.
Resistance to lopinavir, defined as the presence of any primary or active site mutations in protease (see above), was observed in 0/51 (0%) patients.
Rezistencija na lopinavir, definirana kao prisustvo bilo kojeg primarnog ili aktivnog mjesta mutacije u proteazi (vidjeti gore), je zabilježena kod 0/51 (0%) bolesnika.
Greater effects may be expected when fluticasone propionate is inhaled.
Jači se učinci mogu se očekivati kada se flutikazonpropionat inhalira.
The combination should be used with caution and a lower dose of trazodone should be considered.
Ta kombinacija se mora primjenjivati s oprezom i razmotriti primjenu manje doze trazodona.
Pharmacotherapeutic group: antivirals for systemic use, antivirals for treatment of HIV infections, combinations, ATC code: J05AR10
Farmakoterapijska skupina: antivirusni lijekovi za sistemsku primjenu, kombinirani antivirusni lijekovi za liječenje infekcije HIV-om, ATK oznaka: J05AR10
Lopinavir/ritonavir tablets have also shown less pharmacokinetic variability under all meal conditions compared to lopinavir/ritonavir soft capsules.
Tablete lopinavira/ritonavira su također pokazale manju farmakokinetičku varijabilnost u svim uvjetima obroka u odnosu na meke kapsule lopinavira/ritonavira.
The combination may result in increased risk of cardiovascular adverse events associated with salmeterol, including QT prolongation, palpitations and sinus tachycardia.
Kombinacija može rezultirati u povećanom riziku od kardiovaskularnih nuspojava povezanih sa salmeterolom, uključujući QT prolongaciju, palpitacije i sinusnu tahikardiju.
Uncommon Weight increased, increased appetite
Nuspojava Manje često Povećanje tjelesne težine, povećanje apetita
UNIQUE IDENTIFIER - 2D BARCODE Not applicable
17. JEDINSTVENI IDENTIFIKATOR - 2D BARKOD Nije primjenjivo.
− If you realise you have taken more lopinavir/ritonavir than you were supposed to, contact your doctor right away.
Ako shvatite da ste uzeli više lopinavira/ritonavira nego što ste trebali, odmah obavijestite svog liječnika.
Patients had a mean age of 5 years (range 6 months to 12 years) with 14 patients less than 2 years old and 6 patients one year or less.
Srednja dob bolesnika bila je 5 godina (raspon: od 6 mjeseci do 12 godina), pri čemu je 14 bolesnika bilo mlađe od 2 godine, a njih 6 bilo je u dobi od jedne godine ili mlađe.
Headache (including migraine), neuropathy (including peripheral neuropathy), dizziness, insomnia
Glavobolja (uključujući migrenu), neuropatija (uključujući perifernu neuropatiju), omaglica, nesanica
All interaction studies, when otherwise not stated, were performed using lopinavir/ritonavir capsules, which gives an approximately 20% lower exposure of lopinavir than the 200/50 mg tablets.
Sve studije interakcija, ukoliko nije drugačije naznačeno, provedene su koristeći lopinavir/ritonavir kapsule, koje pružaju za oko 20% manju izloženost lopinaviru nego 200/50 mg tablete.
Tissue distribution studies conducted in the rat did not suggest significant cardiac retention of the active substance; 72-hour AUC in heart was approximately 50% of measured plasma AUC.
Ispitivanja distribucije u tkivima, provedena u štakora, nisu uputila na znatnije zadržavanje lijeka u srcu; AUC u srcu nakon 72 sata bila je otprilike 50 % od AUC izmjerene u plazmi.
A limited increase in total lopinavir concentrations of approximately 30% has been observed which is not expected to be of clinical relevance (see section 4.2).
Uočen je ograničeni porast ukupnih koncentracija lopinavira od oko 30%, no ne očekuje se da bi to moglo biti od kliničkog značaja (vidjeti dio 4.2).
If there is evidence of worsening liver disease in such patients, interruption or discontinuation of treatment should be considered.
Jave li se u tih bolesnika znaci pogoršanja bolesti jetre, valja razmotriti prekid ili ukidanje terapije.
Dieselweg 25, 3752 Bunschoten The Netherlands
Dieselweg 25, 3752 Bunschoten Nizozemska
Therefore, this co-administration should be avoided unless judged strictly necessary.
Stoga se istodobna primjena tih lijekova mora izbjegavati, osim ako se ona ne ocijeni doista nužnom.
Further stratification within each group was 1:1 (tablet versus.
Daljna podjela svake grupe bila je također u omjeru 1:1 (tablete naspram kapsula).
The plasma levels of ritonavir are less than 7% of those obtained after the ritonavir dose of 600 mg twice daily.
Koncentracije ritonavira u plazmi su manje od 7 % od onih koje se postižu pri dozi ritonavira od 600 mg dvaput na dan.
Haemophiliac patients should therefore be made aware of the possibility of increased bleeding.
Stoga se bolesnike s hemofilijom mora obavijestiti da postoji povećani rizik od krvarenja.
Treatment of overdose with lopinavir/ritonavir is to consist of general supportive measures including monitoring of vital signs and observation of the clinical status of the patient.
Liječenje predoziranja lopinavirom/ritonavirom treba se sastojati od općih suportivnih mjera, uključivši praćenje vitalnih znakova i kliničkog statusa bolesnika.
− Muscle pain, tenderness or weakness, particularly in combination with these medicines.
Mišićnu bol, osjetljivost ili slabost, osobito prilikom uzimanja ovih lijekova.
QTcF interval was evaluated in a randomised, placebo and active (moxifloxacin 400 mg once daily) controlled crossover study in 39 healthy adults, with 10 measurements over 12 hours on Day 3.
QTcF interval procijenjen je u randomiziranom, s placebom i aktivnom kontrolom (moksifloksacin 400 mg jednom dnevno) kontroliranoj crossover studiji u 39 zdravih osoba, s 10 mjerenja kroz 12 sati tijekom trećeg dana studije.
Do not use this medicine after the expiry date which is stated on the carton after EXP.
Nemojte uzimati ovaj lijek nakon isteka roka valjanosti navedenog na kutiji iza Rok valjanosti.
In some patients with advanced HIV infection and a history of opportunistic infection, signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started.
Kod nekih bolesnika s uznapredovalom HIV infekcijom i oportunističkom infekcijom u povijesti bolesti, znakovi i simptomi upale od prethodno preboljelih infekcija mogu se pojaviti ubrzo nakon početka anti-HIV liječenja.
Thereby, increasing the potential for sildenafilassociated adverse events (which include hypotension and syncope).
Time je povećana mogućnost pojave štetnih događaja povezanih sa sildenafilom (koje uključuju hipotenziju i sinkopu).
Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Detaljnije informacije o ovom lijeku dostupne su na web stranici Europske agencije za lijekove http://www.ema.europa.eu
Lopinavir/ritonavir does this by slowing down the spread of the infection in your body.
Lopinavir/ritonavir to čini usporavajući širenje infekcije u Vašem tijelu.
− It is recommended that HIV-infected women do not breast-feed their infants because there is a possibility that the baby can be infected with HIV through your breast milk.
Ne preporučuje se HIV pozitivnim ženama da doje jer postoji mogućnost zaraze djeteta HIV-om putem majčinog mlijeka.
UNIQUE IDENTIFIER - HUMAN READABLE DATA Not applicable
JEDINSTVENI IDENTIFIKATOR - PODACI ČITLJIVI LJUDSKIM OKOM Nije primjenjivo.
(combinations of mechanisms including CYP3A inhibition)
(kombinacije mehanizama uključujući inhibiciju CYP3A)
− If you are currently using an oral contraceptive or using a patch contraceptive to prevent pregnancy, you should use an additional or different type of contraception (e.g. condom) as lopinavir/ritonavir may reduce the effectiveness of oral and patch contraceptives.
Ukoliko koristite oralne ili flaster kontraceptive za prevenciju trudnoće, morali biste koristiti i dodatnu kontracepciju ili drugi oblik kontracepcije (npr. kondom) jer lopinavir/ritonavir može smanjiti učinkovitost oralnih i flaster kontraceptiva.
The marketing authorisation holder (MAH) shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreed subsequent updates of the RMP.
Nositelj odobrenja obavljat će potrebne farmakovigilancijske aktivnosti i intervencije, detaljno objašnjene u dogovorenom Planu upravljanja rizikom(RMP), a koji je opisan u Modulu 1.8.2
HMG Co-A Reductase Inhibitors
Inhibitori HMG Co-A reduktaze
Through Week 96, genotypic resistance testing results were available from 25 patients in the QD group and 26 patients in the BID group who had incomplete virologic response.
U 96. tjednu rezultati testiranja genotipske rezistencije su bili dostupni od 25 bolesnika iz QD grupe i 26 bolesnika iz BID grupe koji su imali nepotpun virološki odgovor.
INFORMATION IN BRAILLE
16. PODACI NA BRAILLEOVU
• Once daily administration of lopinavir/ritonavir is not recommended for pregnant women due to the lack of pharmacokinetic and clinical data.
• Kod trudnica se primjena lopinavira/ritonavira jednom dnevno ne preporučuje zbog nedostatka farmakokinetičkih i kliničkih podataka.
Co-administration with other HIV protease inhibitors (PIs) According to current treatment guidelines, dual therapy with protease inhibitors is generally not recommended.
Istodobna primjena s drugim inhibitorima HIV proteaza (PI; engl. protease inhibitor) Prema postojećim smjernicama za liječenje, dvojno liječenje inhibitorima proteaza općenito se ne preporučuje.
− Do not stop or change the daily dose of lopinavir/ritonavir without first consulting with your doctor.
Ne prekidajte uzimanje i ne mijenjajte dnevnu dozu lopinavira/ritonavira bez prethodne konzultacije s liječnikom.
Protocol defined non-inferiority of once daily dosing compared with twice daily dosing was demonstrated if the lower bound of the 95% confidence interval for the difference in proportion of subjects responding (once daily minus twice daily) excluded -12% at Week 48.
Protokolom definirana neinferiornost doziranja jednom dnevno naspram doziranja dva puta dnevno pokazana je ako donja granica 95%-nog intervala pouzdanosti za razliku u proporciji odgovora ispitanika (jednom dnevno minus dva puta dnevno) ne prelazi -12 % u 48. tjednu.
* The tablets must not be chewed, broken or crushed.
* Tablete se ne smiju žvakati, lomiti ili drobiti.