natgillin/translations-raw huggingface dataset:
Following the provisions under Article 20 of Regulation (EC) No 726/2004, the CHMP, having considered the PRAC recommendation dated 5 December 2013, is of the opinion that the marketing authorisations for Kogenate Bayer and Helixate NexGen should be varied as recommended by the PRAC.
Uredbe (EZ) br. 726/2004, nakon što je razmotrio preporuku PRAC-a od 5. prosinca 2013., mišljenje je CHMP-a da se odobrenja za stavljanje u promet lijekova Kogenate Bayer i Helixate NexGen trebaju izmijeniti sukladno preporuci PRAC-a.
The PRAC considered results from the publication of the RODIN/PedNet study, the preliminary findings from the European Haemophilia Safety Surveillance System (EUHASS) registry and all available data submitted from clinical trials, observational studies, published literature as well as quality data for Kogenate Bayer and Helixate NexGen with regards to its potential risk of inhibitor development in previously untreated patients (PUPs) and minimally treated patients (MTPs).
PRAC je razmotrio rezultate dostupne iz publikacija ispitivanja RODIN/PedNet, preliminarnih nalaza iz registra Europskog sustava za sigurnosni nadzor hemofilije (EUHASS), kao i sve dostupne podatke dostavljene iz kliničkih ispitivanja, opservacijskih ispitivanja, objavljene literature te podatke o kvaliteti za lijekove Kogenate Bayer i Helixate NexGen u vezi s njihovim potencijalnim rizikom od razvoja inhibitora u prethodno neliječenih bolesnika (PUP-ova) i minimalno liječenih bolesnika (MTP-ova).
• The PRAC considered the publication of the results of the RODIN/PedNet study, the preliminary findings from the European Haemophilia Safety Surveillance System (EUHASS) registry and all available data submitted from clinical trials, observational studies, published literature and quality data for Kogenate Bayer and Helixate NexGen with regards to its potential risk of inhibitor development in previously untreated patients (PUPs).
• je PRAC razmotrio rezultate dostupne iz publikacija ispitivanja RODIN/PedNet, preliminarnih nalaza iz registra Europskog sustava za sigurnosni nadzor hemofilije (EUHASS), kao i sve dostupne podatke dostavljene iz kliničkih ispitivanja, opservacijskih ispitivanja, objavljene literature te podatke o kvaliteti za lijekove Kogenate Bayer i Helixate NexGen u vezi s njihovim potencijalnim rizikom od razvoja inhibitora u prethodno neliječenih bolesnika (PUP-ova),
• The PRAC noted that the efficacy of Kogenate Bayer/Helixate NexGen is not questioned and, on the basis of the available data, concluded that the current results do not confirm an increased risk of developing antibodies against Kogenate Bayer and Helixate NexGen when compared with other factor VIII products in PUPs with the bleeding disorder haemophilia A.
NexGen nije upitna, te da je na temelju dostupnih podataka zaključio da aktualni rezultati ne potvrđuju povećani rizik od razvoja protutijela protiv lijeka Kogenate Bayer i Helixate NexGen u usporedbi s lijekovima faktora VIII u PUP-ova s poremećajem krvarenja hemofilije A,
Development of inhibitors against FVIII is the most significant complication of replacement therapy for haemophilia A. These antibodies inactivate the pro-coagulant activity of FVIII and inhibit patients' response to FVIII replacement therapy which may result in life-threatening bleedings and sequelae.
Ova protutijela inaktiviraju prokoagulacijsko djelovanje faktora VIII i inhibiraju odgovor bolesnika na zamjensku terapiju faktorom VIII što može rezultirati krvarenjima i posljedicama opasnima po život.
Having noted the above, the PRAC concluded that the benefit-risk balance of Kogenate Bayer and Helixate NexGen indicated as for the treatment and prophylaxis of bleeding in patients with hemophilia A (congenital factor VIII deficiency) remains favourable subject to the changes to the product information agreed.
Nakon što je istaknuo prethodno navedeno, PRAC je zaključio da omjer koristi i rizika lijekova Kogenate Bayer i Helixate NexGen indiciran za liječenje i profilaksu krvarenja u bolesnika oboljelih od hemofilije A (prirođenog nedostatka faktora VIII) ostaje povoljan i podliježe usuglašenim izmjenama informacija o lijeku.
The PRAC therefore concluded that the benefit-risk balance of Kogenate Bayer and Helixate NexGen indicated as for the treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency) remains favourable subject to the changes to the product information agreed.
stoga je PRAC zaključio da omjer koristi i rizika lijekova Kogenate Bayer i Helixate NexGen indiciran za liječenje i profilaksu krvarenja u bolesnika oboljelih od hemofilije A (prirođenog nedostatka faktora VIII) ostaje povoljan i podliježe usuglašenim izmjenama informacija o lijeku.
J. Med. 368, 231 (2013)) were made available and seemed to suggest that Kogenate Bayer/Helixate NexGen were associated with an increased risk of inhibitor development in previously untreated patients (PUPs) when compared to another recombinant antihaemophilic factor VIII, after adjustment for confounding factors.
NexGen povezani s povećanim rizikom od razvoja inhibitora u prethodno neliječenim bolesnicima (PUP-ima) prilikom usporedbe s drugim rekombinantnim koagulacijskim faktorom VIII, nakon podešavanja usporednih faktora.
In view of the above, the PRAC agreed that the current evidence does not confirm an increased risk of developing antibodies against Kogenate Bayer and Helixate NexGen when compared with other factor VIII products in PUPs with the bleeding disorder haemophilia A. However the PRAC considered that the frequency for inhibitor development in PUPs should be amended from “common” to “very common” in the section 4.8 of the SmPC and also recommended that the product information should be updated with results from the RODIN study as part of the routine risk minimisation activities.
No, PRAC je zaključio da se učestalost za razvoj inhibitora u PUP-ova mora izmijeniti iz „često” u „vrlo često” u dijelu 4.8 SPC-a, te je preporučio da se informacije o lijeku ažuriraju rezultatima ispitivanja RODIN kao sastavni dio rutinskih aktivnosti za smanjivanje rizika.
In support of the above mentioned clinical data, the MAH provided information with regards to the manufacturing process (i.e. growth condition, purification) of Kogenate Bayer /Helixate Nexgen and discussed any change which took place since the studies 200021EU and 100074US.
/Helixate Nexgen, te je raspravio sve izmjene koje su primijenjene nakon ispitivanja 200021EU i 100074US.
Further information on Cyramza can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/cyramza.
Više informacija o lijeku Cyramza dostupno je na internetskim stranicama Agencije: ema.europa.eu/medicines/human/EPAR/cyramza.
Although the effects were modest, the size of the benefit was considered clinically relevant given the normally poor prognosis in these patients.
Premda su učinci bili skromnih razmjera, opseg koristi od lijeka smatrao se klinički značajnim s obzirom na uobičajeno loše prognoze za te bolesnike.
Cyramza received a marketing authorisation valid throughout the EU on 19 December 2014.
Lijek Cyramza dobio je odobrenje za stavljanje u promet koje je na snazi u EU-u od 19. prosinca 2014.
What measures are being taken to ensure the safe and effective use of Cyramza?
Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Cyramza?
What is Cyramza and what is it used for?
Što je Cyramza i za što se koristi?
• hepatocellular carcinoma (a type of liver cancer) that is advanced or cannot be removed with surgery.
• hepatocelularnog karcinoma (vrste raka jetre) koji je uznapredovao ili se ne može ukloniti kirurškim zahvatom.
• metastatic colorectal cancer (cancer of the large bowel that has spread to other parts of the body).
• metastatskog kolorektalnog raka (raka debelog crijeva koji se proširio na ostale dijelove tijela).
Other information about Cyramza
Ostale informacije o lijeku Cyramza
Cyramza is a cancer medicine used to treat adult patients with:
Cyramza je lijek protiv raka koji se primjenjuje za liječenje odraslih osoba oboljelih od:
The European Medicines Agency decided that Cyramza's benefits are greater than its risks and it can be authorised for use in the EU.
Europska agencija za lijekove zaključila je da koristi od lijeka Cyramza nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u EU-u.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Cyramza have been included in the summary of product characteristics and the package leaflet.
Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Cyramza nalaze se u sažetku opisa svojstava i u uputi o lijeku.
By attaching to VEGFR, ramucirumab blocks this action, reducing the blood supply to the tumour and so slowing the growth of the cancer.
Vezivanjem na VEGFR, ramucirumab blokira taj razvoj i time smanjuje dotok krvi u tumor, čime se usporava rast raka.
Side effects reported with Cyramza are carefully evaluated and any necessary action taken to protect patients.
Nuspojave prijavljene za lijek Cyramza pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
The safety profile of Cyramza is in line with that expected for other medicines blocking VEGFR activity and is considered manageable.
Sigurnosni profil lijeka Cyramza u skladu je s očekivanim za druge lijekove koji blokiraju djelovanje VEGFR-a i moguće ga je kontrolirati.
As for all medicines, data on the use of Cyramza is continuously monitored.
Kao i za sve lijekove, podatci o primjeni lijeka Cyramza kontinuirano se prate.
Why is Cyramza authorised in the EU?
Zašto je lijek Cyramza odobren u EU-u?
An overview of Cyramza and why it is authorised in the EU
Pregled informacija o lijeku Cyramza i zašto je odobren u EU-u
Cyramza contains the active substance ramucirumab.
Cyramza sadrži djelatnu tvar ramucirumab.
VEGFRhelps in the development of new blood vessels that supply the tumours.
Protein VEGFR pomaže u razvoju novih krvnih žila koje opskrbljuju tumore.
What are the risks associated with Cyramza?
Koji su rizici povezani s lijekom Cyramza?
It can only be obtained with a prescription and treatment should be started and supervised by a specialist who has experience in the treatment of cancer.
Lijek Cyramza izdaje se samo na recept, a liječenje mora započeti i nadzirati liječnik s iskustvom u liječenju raka.
When used for lung cancer, Cyramza must not be used when there is a cavity in the cancer or if the cancer is close to a major blood vessel.
Kada se koristi za liječenje raka pluća, lijek Cyramza ne smije se primjenjivati ako rak u sebi ima šupljinu ili ako se nalazi blizu velike krvne žile.
• advanced gastric cancer (cancer of the stomach) or cancer of the area where the gullet (oesophagus) enters the stomach (known as gastro-oesophageal junction adenocarcinoma).
• uznapredovalog raka želudca (gastričnog raka) ili raka dijela tijela u kojem jednjak (ezofagus) ulazi u želudac (poznat kao adenokarcinom gastroezofagealnog spoja).
• non-small cell lung cancer that is advanced or has spread to other parts of the body.
• raka pluća nemalih stanica koji je uznapredovao ili se proširio na ostale dijelove tijela.
The most common side effects with Cyramza (which may affect more than 1 in 10 people) include tiredness or weakness, leucopenia (low white blood cell counts), neutropenia (low counts of a particular type of white blood cell), diarrhoea, nosebleeds and stomatitis (inflammation of the lining of the mouth).
Najčešće nuspojave lijeka Cyramza (koje se mogu javiti u više od 1 na 10 osoba) jesu umor ili slabost, leukopenija (nizak broj bijelih krvnih stanica), neutropenija (nizak broj određene vrste bijelih krvnih stanica), proljev, krvarenja iz nosa i stomatitis (upala sluznice usne šupljine).
The benefit was smaller when Cyramza was given on its own, but this could still be an option when treatment with paclitaxel is not considered appropriate.
Koristi od lijeka bile su manje ako se lijek Cyramza davao kao monoterapija, ali to može ostati kao mogućnost ako se davanje paklitaksela ne smatra primjerenim.
The dose of Cyramza and how often it is given depends on the patient's weight and the condition being treated.
Doza i učestalost primjene lijeka Cyramza ovise o tjelesnoj težini bolesnika i stanju koje se liječi.
The active substance in Cyramza, ramucirumab, is a monoclonal antibody (a type of protein) designed to attach to vascular endothelial growth factor receptor (VEGFR), a protein present at high levels in tumours.
Djelatna tvar u lijeku Cyramza, ramucirumab, monoklonsko je protutijelo (vrsta proteina) namijenjeno vezivanju na vaskularni endotelni faktor rasta (VEGFR), protein koji je prisutan u velikim količinama u tumorima.
Cyramza is used in combination with docetaxel in patients whose disease has worsened despite treatment with medicines containing platinum;
Lijek Cyramza koristi se u kombinaciji s docetakselom u onih bolesnika čija se bolest pogoršala unatoč terapiji lijekovima koji sadržavaju platinu;
Cyramza is given by infusion (drip) into a vein.
Lijek Cyramza daje se intravenskom infuzijom (ukapavanjem).
How does Cyramza work?
Kako djeluje Cyramza?
Cyramza is used in combination with another medicine, paclitaxel, or on its own if the combination with paclitaxel is not appropriate, in patients whose disease has worsened despite treatment with medicines containing platinum or fluoropyrimidines (a class of medicines that includes capecitabine, fluorouracil and tegafur);
Lijek Cyramza koristi se u kombinaciji s drugim lijekom, paklitakselom, ili kao monoterapija ako kombinacija s paklitakselom nije prikladna, u onih bolesnika čija se bolest pogoršala unatoč terapiji lijekovima koji sadrže platinu ili fluoropirimidine (razred lijekova koji uključuje kapecitabin, fluorouracil i tegafur);
Similarly, in another study in 355 patients, those treated with Cyramza plus best supportive care lived longer than patients receiving placebo plus best supportive care (an average of 5.2 months versus 3.8 months, respectively).
Slično tome, u drugom ispitivanju na 355 bolesnika, oni bolesnici koji su bili liječeni lijekom Cyramza uz najbolju potpornu skrb živjeli su dulje od bolesnika koji su primali placebo uz najbolju potpornu skrb (u prosjeku 5,2 mjeseca naspram 3,8 mjeseci).
Cyramza is used on its own in patients with a high blood level of a protein called alpha fetoprotein (AFP) and who have been previously treated with sorafenib.
Lijek Cyramza koristi se kao monoterapija u bolesnika s visokom razinom proteina pod nazivom alfa-fetoprotein (AFP) i onih koji su prethodno bili liječeni sorafenibom.
What benefits of Cyramza have been shown in studies?
Koje su koristi od lijeka Cyramza utvrđene u ispitivanjima?
Treatment should continue for as long as the patient benefits from it. For more information about using Cyramza, see the package leaflet or contact your doctor or pharmacist.
Za više informacija o primjeni lijeka Cyramza pročitajte uputu o lijeku, odnosno obratite se liječniku ili ljekarniku.
Cyramza is used with ‘FOLFIRI' chemotherapy (a combination of fluorouracil, folinic acid and irinotecan) in patients whose disease has worsened despite treatment with bevacizumab, oxaliplatin and a fluoropyrimidine;
Lijek Cyramza koristi se uz kemoterapiju „FOLFIRI” (kombinacija fluorouracila, folne kiseline i irinotekana) u onih bolesnika čija se bolest pogoršala unatoč terapiji bevacizumabom, oksaliplatinom i fluoropirimidinom;
The Agency noted that Cyramza prolonged the lives of patients with gastric and gastro-oesophageal junction cancer when it was given with paclitaxel.
Agencija je napomenula da se primjenom lijeka Cyramza produljio život bolesnika oboljelih od raka gastroezofagealnog spoja ako se lijek davao uz paklitaksel.
The most serious adverse effects reported (either of Cyramza alone or in combination with other cancer medicines) included gastrointestinal perforation (a hole that develops in the wall of the gut), severe gastrointestinal haemorrhage (bleeding from the gut) and arterial thromboembolic events
Najozbiljnije zabilježene nuspojave (kod monoterapije lijekom Cyramza ili u kombinaciji s drugim lijekovima protiv raka) uključivale su perforaciju u probavnom sustavu (pukotina koja se razvije u stijenci crijeva), teško krvarenje u probavnom sustavu (krvarenje iz crijeva) i arterijske tromboembolijske događaje (problemi uzrokovani krvnim ugrušcima i začepljenjem arterija).
Cyramza increased survival of patients with advanced gastric or gastro-oesophageal junction cancer, metastatic colorectal cancer, advanced or metastatic non-small cell lung cancer and hepatocellular carcinoma in 5 main studies.
Lijekom Cyramza u pet se glavnih ispitivanja povećala stopa preživljenja u bolesnika s uznapredovalim rakom želudca ili rakom gastroezofagealnog spoja, metastatskim kolorektalnim rakom, uznapredovalim ili metastatskim rakom pluća nemalih stanica i hepatocelularnim karcinomom.
In a study involving 292 patients with hepatocellular carcinoma that is advanced or cannot be removed with surgery and who have high AFP blood level and have been previously treated with sorafenib, patients receiving Cyramza lived longer than those receiving placebo: 8.5 versus 7.3 months, respectively.
U glavnom ispitivanju na 292 bolesnika s hepatocelularnim karcinomom koji je uznapredovao ili se ne može ukloniti kirurškim zahvatom i koji imaju visoku razinu alfa-fetoproteina (AFP) u krvi te su prethodno bili liječeni sorafenibom, bolesnici koji su primali lijek Cyramza živjeli su dulje od onih koji su primali placebo: 8,5 mjeseci naspram 7,3 mjeseca.
Cyramza also prolonged survival of patients with colorectal cancer, non-small cell lung cancer and hepatocellular carcinoma.
Primjenom lijeka Cyramza produljio se život i bolesnika s kolorektalnim rakom, rakom pluća nemalih stanica i hepatocelularnim karcinomom.
In one main study involving 665 patients with advanced gastric or gastro-oesophageal junction cancer which worsened despite treatment with medicines containing platinum and a fluoropyrimidine, those treated with Cyramza and paclitaxel lived longer than patients receiving paclitaxel and placebo (a dummy treatment): on average 9.6 months versus 7.4 months respectively.
U jednom glavnom ispitivanju na 665 bolesnika s uznapredovalim rakom želudca ili rakom gastroezofagealnog spoja koji su se pogoršali unatoč terapiji lijekovima koji sadrže platinu i fluoropirimidin, oni bolesnici koji su bili liječeni lijekom Cyramza i paklitakselom živjeli su dulje od bolesnika koji su primali paklitaksel i placebo (prividno liječenje): u prosjeku 9,6 mjeseci naspram 7,4 mjeseca.
How is Cyramza used?
Kako se Cyramza primjenjuje?
For the full list of side effects of Cyramza, see the package leaflet.
Potpuni popis zabilježenih nuspojava povezanih s lijekom Cyramza potražite u uputi o lijeku.
In a main study involving 1,253 patients with advanced or metastatic non-small cell lung cancer which worsened despite treatment with medicines containing platinum, those treated with Cyramza and docetaxel lived longer than patients receiving docetaxel and placebo: on average 10.5 months versus 9.1 months respectively.
U glavnom ispitivanju na 1 253 bolesnika s uznapredovalim ili metastatskim rakom pluća nemalih stanica koji se pogoršao unatoč terapiji lijekovima koji sadrže platinu, oni bolesnici koji su bili liječeni lijekom Cyramza i docetakselom živjeli su dulje od bolesnika koji su primali docetaksel i placebo: u prosjeku 10,5 mjeseci naspram 9,1 mjesec.
In a main study involving 1,072 patients with metastatic colorectal cancer which worsened despite treatment with bevacizumab, oxaliplatin and a fluoropyrimidine, those treated with Cyramza and FOLFIRI lived longer than patients receiving FOLFIRI and placebo: on average 13.3 months versus 11.7 months respectively.
U glavnom ispitivanju na 1 072 bolesnika oboljelih od metastatskog kolorektalnog raka koji se pogoršao unatoč terapiji bevacizumabom, oksaliplatinom i fluoropirimidinom, oni bolesnici koji su bili liječeni lijekom Cyramza uz protokol FOLFIRI, živjeli su dulje od bolesnika koji su bili liječeni placebom uz protokol FOLFIRI; u prosjeku 13,3 mjeseca naspram 11,7 mjeseci.
• The Committee considered the notification of the referral triggered by the United Kingdom under Article 29(4) of Directive 2001/83/EC;
• Povjerenstvo je razmotrilo obavijest o upućivanju koje je pokrenulo Ujedinjeno Kraljevstvo prema članku 29. stavak 4. Direktive 2001/83/EZ;
Sorbitol is a non-absorbable sugar alcohol that is used in ‘sugar-free' formulations because it does not crystallise around the bottle opening and cap.
Sorbitol je šećerni alkohol koji se ne može apsorbirati i upotrebljava se u formulacijama „bez šećera” jer se ne kristalizira oko otvora i zatvarača boce.
3 Chen M. Straughn A, Sadrieh N. et al (2007).
Straughn A, Sadrieh N. et al (2007).
• The Committee reviewed all the data submitted by the marketing authorisation holder to address the potential serious risk to public health with regard to the efficacy and safety for Okrido 6 mg/ml oral solution.
• Povjerenstvo je pregledalo sve podatke koje je dostavio nositelj odobrenja za stavljanje lijeka u promet kako bi se uzeo u obzir mogući ozbiljni rizik za javno zdravlje u odnosu na djelotvornost i sigurnost oralne otopine Okrido od 6 mg/ml.
Efficacy was measured by patients and physician by rating resolution of symptoms as well as safety and tolerability.
Djelotvornost su mjerili pacijenti i liječnici ocjenjujući rješavanje simptoma te sigurnost i podnošljivost.
Permeability/Absorption
Propusnost/apsorpcija
Excipients
Res.
For Okrido, this equates to 0.536 mg/ml for prednisolone phosphate.
Za Okrido to je jednako količini od 0,536 mg/ml za prednisolon fosfat.
Symposium der GD-Fachgruppe Magistralrezepturen: Neues zur Qualitätssicherung dermatologischer Rezepturen
Neues zur Qualitätssicherung dermatologischer Rezepturen
• The Committee also noted the literature data that was submitted, which showed that sorbitol in oral prednisolone solutions would not exert a clinically relevant effect in terms of efficacy and safety, although recognised that this literature was less relevant to the consideration of the biowaver.
• Povjerenstvo je također razmotrilo dostavljene podatke iz literature, koji su pokazali da sorbitol u oralnim otopinama prednisolona ne bi klinički bitno utjecao na djelotvornost i sigurnost, iako se priznaje da je ova literatura manje mjerodavna za razmatranje izostavljanja ispitivanja bioekvivalencije.
The authors of the study found that there was no difference in dyspnoea scores and concluded therapeutic equivalence, implying also bioequivalence.
Autori studije utvrdili su da nema razlike u rezultatima u odnosu na dispneju i zaključili su da postoji terapeutska ekvivalencija, koja također podrazumijeva bioekvivalenciju.
The proposed indications for Okrido oral solution 6mg/ml include a wide range of conditions where symptomatic anti-inflammatory/ immunosuppressive therapy is required.
Predložene indikacije za oralnu otopinu Okrido od 6 mg/ml obuhvaćaju široki raspon stanja kod kojih je neophodna simptomatična protuupalna/imunosupresivna terapija.
This is in accordance with bioavailability literature data of prednisolone.
To je u skladu s podacima o prednisolonu iz literature o biodstupnosti.
However taking into account the high solubility, and the rapid and almost complete absorption along the entire length of the small intestine, the CHMP was of the view that the amount of prednisolone absorbed will not be significantly affected by decreased residence time of the administered dose in any segment of the intestine, or reduced intestinal residence time overall.
Međutim, uzevši u obzir visoku topivost i brzu te gotovo potpunu apsorpciju duž čitavog tankog crijeva, CHMP je smatrao da na apsorbiranu količinu prednisolona neće znatno utjecati skraćeno vrijeme zadržavanja primijenjene doze u bilo kojem segmentu crijeva, ili ukupno skraćeno intestinalno vrijeme zadržavanja.