FrancophonIA/ELRC3.0 huggingface dataset:
English: If a central venous access device (CVAD) is required, risk of CVAD-related complications including local infections, bacteraemia and catheter site thrombosis should be considered.
Croatian: Ako je potreban centralni venski kateter, treba uzeti u obzir rizik od komplikacija povezanih s centralnim venskim kateterom, uključujući lokalne infekcije, bakterijemiju i trombozu na mjestu uvođenja katetera.
English: After reconstitution this medicinal product contains 0.156 mmol sodium per vial of reconstituted solution (corresponding to 3.59 mg per vial).
Croatian: Nakon rekonstitucije ovaj lijek sadrži 0,156 mmol natrija po bočici rekonstituirane otopine (što odgovara 3,59 mg po bočici).
English: T1/2 (h) AUC (IU.h/dL)** CL (dL/h/kg) Vss (dL/kg) * Based on population PK estimates **AUC calculated for a dose of 50 IU/kg
Croatian: T1/2 (h) AUC (IU.h/dl)** CL (dl/h/kg) Vss (dl/kg)
English: * Frequency is based on studies with all FVIII products which included patients with severe haemophilia A. PTPs = previously-treated patients **includes injection site extravasation, hematoma, infusion site pain, pruritus, swelling *** rash, rash erythematous, rash pruritic
Croatian: *Učestalost se temelji na ispitivanjima sa svim lijekovima s FVIII koja su uključivala bolesnike s teškom hemofilijom A. PTPs = prethodno liječeni bolesnici (engl. previously-treated patients) ** uključuje ekstravazaciju na mjestu injekcije, hematom, bol na mjestu infuzije, svrbež, oticanje *** osip, eritematozni osip, osip praćen svrbežom
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Croatian: U svakoj skupini učestalosti, nuspojave su navedene od ozbiljnijih prema manje ozbiljnima.
English: Elevation of FVIII levels following administration, in particular in those with existing cardiovascular risk factors, might cause a patient to have the same risk for vessel closure or myocardial infarction as for the non-haemophilic population.
Croatian: Povišenje razine FVIII nakon primjene, posebice u bolesnika s postojećim kardiovaskularnim faktorima rizika, može u bolesnika uzrokovati jednaki rizik za začepljenje krvne žile ili infarkt miokarda kao u populacije koja nema hemofiliju.
English: The safety and efficacy of Iblias in previously untreated patients have not yet been established.
Croatian: Sigurnost i djelotvornost lijeka Iblias u bolesnika koji prethodno nisu liječeni nisu još ustanovljene.
English: 12-<18 years N=23
Croatian: 12-<18 godina N=23
English: In some cases, especially in younger patients, shorter dose intervals or higher doses may be necessary.
Croatian: U nekim slučajevima, posebno u mlađih bolesnika, mogu biti potrebni kraći vremenski razmaci između doza ili veće doze.
English: Detailed instructions for preparation and administration are contained in the package leaflet provided with Iblias.
Croatian: Detaljne upute za pripremu i primjenu lijeka navedene su u uputi o lijeku koja koja je priložena uz Iblias.
English: Usually, treatment for haemophilia needs to be given throughout your life-time.
Croatian: Uglavnom, liječenje hemofilije lijekom Iblias traje tijekom cijelog života.
English: Development of antibodies to mouse and hamster protein with related hypersensitivity reactions may occur.
Croatian: Može doći do razvoja protutijela na proteine miša ili hrčka s posljedičnim reakcijama preosjetljivosti.
English: Within its overall shelf life of 30 months the product when kept in its outer carton, may be stored up to 25 °C for a limited period of 12 months.
Croatian: Unutar ukupnog roka valjanosti od 30 mjeseci i kad se čuva u vanjskom pakiranju, lijek se može čuvati na temperaturi do 25 °C u ograničenom razdoblju od 12 mjeseci.
English: Like the UKHCDO study, the FranceCoag study also found no statistically significant increased risk for any rFVIII products vs Advate when French patients (also in the RODIN/Pednet study) were excluded.
Croatian: Kao i ispitivanje UKHCDO, ispitivanje FranceCoag također nije utvrdilo statistički značajan povećan rizik povezan s bilo kojim lijekom s rekombinantnim faktorom VIII u usporedbi s lijekom Advate nakon što su isključeni bolesnici iz Francuske (također obuhvaćeni ispitivanjem RODIN/Pednet).
English: The activated partial thromboplastin time (aPTT) is prolonged in people with haemophilia.
Croatian: U osoba s hemofilijom aktivirano parcijalno tromboplastinsko vrijeme (aPTV) je produljeno.
English: • lymph nodes enlarged (swelling under the skin of the neck, armpit or groin)
Croatian: • povećanje limfnih čvorova (oticanje ispod kože vrata, pazuha ili prepona)
English: Although this became non-significant when UK patients (also included in the
Croatian: No to je postalo beznačajno nakon što su isključeni bolesnici iz Ujedinjene Kraljevine (također obuhvaćeni ispitivanjem RODIN/Pednet).
English: If you switch factor VIII products, you may be at risk of your inhibitor coming back.
Croatian: Ako počnete uzimati neki drugi lijek s faktorom VIII, postoji rizik da se inhibitor ponovno pojavi.
English: Solvent: water for injections, a clear solution.
Croatian: Otapalo: voda za injekcije, bistra otopina.
English: Iblias powder should only be reconstituted with the supplied solvent (2.5 mL or 5 mL water for injections) using the supplied sterile vial filter transfer device.
Croatian: Iblias prašak smije se rekonstituirati samo otapalom (2,5 ml ili 5 ml vode za injekcije) pomoću priloženog sterilnog pribora za prijenos tekućine s filterom za bočicu.
English: After reconstitution this medicinal product contains 0.081 mmol sodium per vial of reconstituted solution (corresponding to 1.86 mg per vial).
Croatian: Nakon rekonstitucije ovaj lijek sadrži 0,081 mmol natrija po bočici rekonstituirane otopine (što odgovara 1,86 mg po bočici).
English: Pregnancy and breast-feeding
Croatian: Trudnoća i dojenje i
English: Patients should be informed of the early signs of hypersensitivity reactions including hives, nausea, generalised urticaria, tightness of the chest, wheezing, hypotension, and anaphylaxis.
Croatian: Bolesnike se mora informirati o ranim znakovima reakcija preosjetljivosti uključujući koprivnjaču, mučninu, generaliziranu urtikariju, stezanje u prsištu, piskanje pri disanju, hipotenziju i anafilaksiju.
English: When infused into a haemophiliac patient, factor VIII binds to vWF in the patient's circulation.
Croatian: Kada se infuzijom primijeni u bolesnika s hemofilijom, faktor VIII vezuje se s vWF-om u bolesnikovu krvotoku.
English: The experts also suggested studies which could further characterise the immunogenic properties of the factor VIII medicinal products (e.g. mechanistic, observational studies).
Croatian: dodatno opisala imunogena svojstva lijekova s faktorom VIII (npr. mehanistička, opservacijska ispitivanja).
English: FVIII inhibition uncommon (PTPs)*
Croatian: Limfadenopatija često Inhibicija faktora VIII manje često (PTPs) *
English: • trouble falling asleep
Croatian: • poteškoće s usnivanjem
English: • an additional package with: - 1 filter transfer device 20/20 [Mix2Vial] - 1 venipuncture set - 1 disposable 5 mL syringe - 2 alcohol swabs for single use
Croatian: • dodatno pakiranje s: - 1 pribor za prijenos tekućine s filterom 20/20 [Mix2Vial] - 1 setom za venepunkciju - 1 jednokratnom štrcaljkom od 5 ml - 2 gazice natopljene alkoholom za jednokratnu uporabu
English: Dose/prophylaxis injection, IU/kg BW median (min, max)
Croatian: Doza/ profilaktička injekcija, IU/kg TT medijan (min; maks)
English: 6-<12 years N=27
Croatian: 6-<12 godina N=27
English: Only the provided infusion sets should be used for reconstitution and injection because treatment failure can occur as a consequence of human recombinant coagulation factor VIII adsorption to the internal surfaces of some infusion equipment.
Croatian: Za rekonstituciju i injiciranje smiju se koristiti samo priloženi infuzijski setovi jer zbog adsorpcije ljudskog rekombinantnog koagulacijskog faktora VIII na unutrašnje površine određene infuzijske opreme liječenje može biti neuspješno.
English: Note the new expiry date on the carton.
Croatian: Na kutiji naznačite novi datum roka valjanosti.
English: Blood and lymphatic system disorders Lymphadenopathy common
Croatian: Poremećaji krvi i limfnog sustava
English: Treatment of bleeding Your doctor will calculate the dose of this medicine and how frequently you should use it to get the necessary level of factor VIII activity in your blood.
Croatian: Liječnik će izračunati dozu i učestalost uzimanja ovog lijeka potrebne za postizanje željene razine aktivnosti faktora VIII u krvi.
English: Let blood flow back to the open end of the venipuncture set and then attach the syringe with the solution.
Croatian: 16. Pustite da krv teče prema otvorenom kraju seta za venepunkciju i zatim pričvrstite štrcaljku s otopinom.
English: Iblias should be reconstituted and administered with the components (vial adapter, vial with water for injections, disposable syringe, venipuncture set) provided with each package.
Croatian: Iblias treba rekonstituirati i primijeniti pomoću pribora (nastavak za bočicu, bočicu s vodom za injekcije, jednokratna štrcaljka, set za venepunkciju) priloženog u pakiranju.
English: One device pack containing: - 1 filter transfer device 20/20 [Mix2Vial] - 1 venipuncture set - 1 disposable 5 mL syringe - 2 alcohol swabs for single use
Croatian: Jedno pakiranje s priborom za primjenu sadrži: - 1 pribor za prijenos tekućine s filterom 20/20 [Mix2Vial] - 1 setom za venepunkciju - 1 jednokratnom štrcaljkom od 5 ml - 2 gazice natopljene alkoholom za jednokratnu uporabu
English: The other ingredients are sucrose, histidine, glycine, sodium chloride, calcium chloride, polysorbate 80 (see end of section 2).
Croatian: Pomoćne tvari su saharoza, histidin, glicin, natrijev klorid, kalcijev klorid, polisorbat 80 (pogledajte kraj dijela 2).
English: May be stored at temperatures up to 25 °C for up to 12 months within the expiry date indicated on the label.
Croatian: Lijek se može čuvati na temperaturi do 25 °C najviše 12 mjeseci unutar razdoblja roka valjanosti navedenog na naljepnici.
English: Carefully remove the blister package from the Mix2Vial set by holding at the rim, and pulling vertically upwards.
Croatian: Pažljivo skinite blister pakiranje sa Mix2Vial seta držeći ga za rub i povlačeći blister okomito prema gore.
English: • if you are allergic to mouse or hamster proteins.
Croatian: • ako ste alergični na bjelančevine miša ili hrčka.
English: Do not use solutions containing visible particles or that are cloudy.
Croatian: Nemojte koristiti otopine koje sadrže vidljive čestice ili koje su zamućene.
English: Study 2 3 x/week dosing
Croatian: Ispitivanje doziranje 2 x tjedno
English: Based on the rare occurrence of haemophilia A in women, experience regarding the use of factor VIII during pregnancy is not available.
Croatian: Zbog rijetke pojave hemofilije A u žena, nema iskustava s primjenom faktora VIII tijekom trudnoće.
English: 0-<6 years N=24
Croatian: 0-<6 godina N=24
English: This medicine contains less than 1 mmol (23 mg) sodium per dose, and is therefore considered essentially ‘sodium- free'.
Croatian: Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po dozi te se stoga smatra da sadrži zanemarive količine natrija.
English: Allergic type hypersensitivity reactions are possible with Iblias.
Croatian: Na lijek Iblias moguće su reakcije preosjetljivosti alergijskog tipa.
English: Treatment with rFVIII normalizes the aPTT similar to that achieved with plasma-derived factor VIII.
Croatian: Liječenje rFVIII-om normalizira aPTV slično kao i primjena faktora VIII dobivenog iz plazme.
English: If you store this medicine at ambient room temperature it expires after 12 months or at the expiry date if this is earlier.
Croatian: Ako čuvate ovaj lijek na sobnoj temperaturi rok valjanosti mu ističe nakon 12 mjeseci ili datuma isteka roka valjanosti, ovisno o tome koji nastupi ranije.
English: The available data showed that in many studies including the EUHASS registry (Iorio A, 20174; Fischer K, 20155) the frequency could be classified as “uncommon”.
Croatian: Dostupni podatci pokazali su da se u brojnim ispitivanjima, uključujući registar EUHASS (Iorio A, 2017
English: Keep the vials in the outer carton in order to protect from light.
Croatian: Bočice držite u vanjskom pakiranju radi zaštite od svjetlosti.
English: Post-authorisation Efficacy Study: In order to investigate the safety and efficacy of Iblias in previously untreated patients the MAH will submit the results of the ongoing study “13400 - Leopold Kids Part B”
Croatian: Ispitivanje djelotvornosti nakon stavljanja lijeka u promet: Kako bi se ispitala sigurnosti i djelotvornost lijeka Iblias u prethodno neliječenih bolesnika, nositelj odobrenja treba dostaviti rezultate ispitivanja u tijeku „13400 -Leopold Kids Part B“
English: However, in some cases, especially for younger patients, shorter dose intervals or higher doses may be necessary.
Croatian: No u nekim je slučajevima, posebno u mlađih bolesnika, potreban kraći vremenski razmak između doza ili su potrebne veće doze.
English: Post-authorisation Efficacy Study: In order to investigate the safety and efficacy of long-term treatment with Iblias, the MAH will submit the results of the ongoing study “13400 - Leopold Kids extension”
Croatian: Ispitivanje djelotvornosti nakon stavljanja lijeka u promet: Kako bi se ispitala sigurnosti i djelotvornost lijeka Iblias u dugotrajnom liječenju, nositelj odobrenja treba dostaviti rezultate ispitivanja u tijeku „13400 -Leopold Kids extension“
English: Skin and subcutaneous tissue disorders Pruritus, rash***, dermatitis allergic common
Croatian: Svrbež, osip***, alergijski dermatitis često
English: Table 2: Frequency of adverse drug reactions in clinical trials MedDRA Standard
Croatian: Tablica 2: Učestalost nuspojava lijeka u kliničkim ispitivanjima MedDRA standardna klasifikacija organskih sustava
English: • allergic reactions including severe sudden allergic reaction
Croatian: • alergijske reakcije
English: Place the solvent vial on an even, clean surface and hold the vial tight.
Croatian: Stavite bočicu s otapalom na ravnu, čistu površinu i čvrsto ju držite.
English: Inject the solution into a vein over 2 to 5 minutes, keeping an eye on the position of the needle.
Croatian: 18. Ubrizgavajte otopinu u venu kroz 2 do 5 minuta, pazeći cijelo vrijeme na položaj igle.
English: Sodium chloride Calcium chloride Polysorbate 80
Croatian: Prašak saharoza histidin glicin natrijev klorid kalcijev klorid polisorbat 80
English: The table presented below is according to the MedDRA system organ classification (SOC and Preferred Term Level).
Croatian: Sljedeća tablica prikazana je prema MedDRA klasifikaciji organskih sustava (organski sustavi i preporučeni izrazi za nuspojave).
English: Eligible patients (<6 years, male, severe haemophilia A, no previous treatment with any FVIII concentrate or only minimal treatment with blood components) were included from 42 sites.
Croatian: Obuhvaćeni su bolesnici sa 42 lokacije koji su ispunjavali uvjete (< šest godina, muški, teška hemofilija A, prethodno neliječeni bilo kojim koncentratom faktora VIII ili samo minimalno liječeni komponentama krvi).
English: Treatment with both pdFVIII and rFVIII can lead to development of inhibitors (tested with the Nijmegen method of the Bethesda assay and defined as ≥ 0.6 Bethesda units (BU) for “a low titre” inhibitor and >5 BU for a “high-titre” inhibitor).
Croatian: Terapija faktorom VIII dobivenim iz plazme i rekombinantnim faktorom VIII može dovesti do razvoja inhibitora (ispitano metodom Nijmegen testa Bethesda i određeno kao ≥ 0,6 Bethesda jedinica (BU) za „nizak titar” inhibitora i ≥ 5 BU za „visok titar” inhibitora).
English: Iblias can be used for all age groups.
Croatian: Iblias se može primjenjivati u bolesnika svih dobnih skupina.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL WITH WATER FOR INJECTIONS
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE BOČICA S VODOM ZA INJEKCIJE
English: Components for reconstitution and administration are provided with each package of this medicine.
Croatian: Svako pakiranje ovog lijeka sadrži komponente za pripremu i primjenu.
English: If you have any further questions regarding this medicine, ask your doctor or pharmacist.
Croatian: U slučaju bilo kakvih pitanja u vezi s ovim lijekom, obratite se svom liječniku ili ljekarniku.
English: Single dose administration only.
Croatian: Primjena samo jedne doze.
English: The solvent will automatically flow into the product vial.
Croatian: Otapalo će automatski teći u bočicu s lijekom.
English: LIST OF EXCIPIENTS Sucrose, histidine, glycine, sodium chloride, calcium chloride, polysorbate 80.
Croatian: POPIS POMOĆNIH TVARI Saharoza, histidin, glicin, natrijev klorid, kalcijev klorid, polisorbat 80.
English: The reconstituted product must be filtered prior to administration to remove potential particulate matter in the solution.
Croatian: Rekonstituirani lijek se prije primjene mora filtrirati kako bi se iz otopine uklonile moguće čestice.
English: Determination of aPTT is a conventional in vitro assay for biological activity of factor VIII.
Croatian: Određivanje aPTV-aje uobičajen in vitro test određivanja biološke aktivnosti faktora VIII.
English: Solvent Water for injections.
Croatian: Otapalo Voda za injekcije.
English: • urticaria (itchy rash)
Croatian: • urtikarija (osippraćen svrbežom)
English: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium- free'.
Croatian: Ovaj lijek sadrži manje od 1 mmol natrija (23 mg) po dozi, tj. zanemarive količine natrija.
English: How Iblias is prepared for administration
Croatian: Kako se lijek Iblias priprema za primjenu
English: 4.9 Overdose No symptoms of overdose with recombinant human coagulation factor VIII have been reported.
Croatian: Nisu zabilježeni simptomi predoziranja rekombinantnim ljudskim koagulacijskim faktorom VIII.
English: The CANAL study2 found no evidence of a class difference, including pdFVIII products with considerable quantities of von Willebrand factor; for ‘clinically relevant' inhibitors the adjusted hazard ratio was 0.7 (95% CI 0.4-1.1), and for high titre inhibitors (≥5 BU) was 0.8 (95% CI 0.4
Croatian: nisu utvrđeni dokazi o različitosti razreda, uključujući lijekove s faktorom VIII dobivenim iz plazme koji su sadržavali znatne količine von Willebrandova faktora; za „klinički relevantne” inhibitore prilagođeni omjer rizika bio je 0,7 (95 % CI 0,4 do 1,1), a za inhibitore visokog titra (≥ 5 BU) bio je 0,8 (95 % CI 0,4 do 1,3).
English: Take the Mix2Vial together with the blister package and push the spike of the blue adapter end straight down through the solvent vial stopper.
Croatian: Uzmite Mix2Vial zajedno s blister pakiranjem i gurnite šiljak na plavom kraju nastavka ravno kroz čep bočice s otapalom.
English: Do not refrigerate after reconstitution.
Croatian: Nakon rekonstitucije ne odlagati u hladnjak.
English: Do not use Iblias if either of the above applies to you.
Croatian: Ako se bilo što od gore navedenog odnosi na Vas, nemojte primijeniti Iblias.
English: Table 4: PK parameters (geometric mean (%CV)) based on chromogenic assay.
Croatian: Tablica 4: PK parametri (geometrijska srednja vrijednost (% CV)) temeljeno na kromogenom testu* PK parametar ≥ 18 godina N=109
English: With one hand grasp the product-side of the Mix2Vial set and with the other hand grasp the solvent-side and unscrew counter clockwise the set carefully into two pieces.
Croatian: Držeći jednom rukom dio Mix2Vial seta na strani bočice s lijekom, a drugom rukom dio Mix2Vial seta na strani bočice s otapalom, odvijte ih u smjeru suprotnom od kazaljke na satu i pažljivo razdvojite u dva dijela.
English: • local reactions where you injected the medication (e.g. bleeding under the skin, intense itching, swelling, burning sensation, temporary redness)
Croatian: • lokalne reakcije na mjestu injiciranja lijeka (npr. krvarenje pod kožom, jak svrbež,
English: Ensure product and solvent vial flip caps are removed and the stoppers are treated with an antiseptic solution and allowed to dry prior to opening the Mix2Vial package.
Croatian: Pobrinite se da zatvarači s bočica s lijekom i otapalom budu skinuti te da se čepovi prebrišu antiseptičnom otopinom i ostave da se osuše prije otvaranja pakiranja Mix2Vial nastavka . Otvorite pakiranje Mix2Vial nastavka skidanjem pokrova.
English: How much Iblias you should use and how often you should use it depends on many factors such as:
Croatian: Količina i učestalost uzimanja lijeka Iblias ovise o brojnim čimbenicima kao što su:
English: Hypersensitivity or allergic reactions (which may include angioedema, burning and stinging at the infusion site, chills, flushing, generalised urticaria, headache, hives, hypotension, lethargy, nausea,
Croatian: Opažene su preosjetljivost ili alergijske reakcije (koje mogu uključivati angioedem, žarenje i peckanje na mjestu infuzije, zimicu, navale crvenila, generaliziranu urtikariju, glavobolju, koprivnjaču, hipotenziju, letargiju, mučninu, nemir, tahikardiju, stezanje u prsištu, trnce, povraćanje, piskanje pri disanju) koje u nekim slučajevima mogu napredovati do teške anafilaksije (uključujući šok).
English: If your or your child's bleeding is not being controlled with Iblias, tell your doctor immediately.
Croatian: Vašeg djeteta ne može kontrolirati pomoću lijeka Iblias odmah se obratite liječniku.
English: • one vial with powder (10 mL clear glass type 1 vial with grey halogenobutyl rubber blend stopper and aluminium seal)
Croatian: • jednu bočicu koja sadrži prašak (bočica od 10 ml od prozirnog stakla tipa 1 sa sivim čepom od halogenobutilne gume i aluminijskim zatvaračem)
English: Factor VIII products and inhibitor development in severe hemophilia A. N Engl J Med 2013; 368: 231-9.
Croatian: Factor VIII products and inhibitor development in severe hemophilia A. N Engl J Med 2013; 368: 231-9. - http://www.bloodjournal.org/content/121/20/4046.full.pdf
English: • you experience tightness in the chest, dizziness (including when you get up from sitting or lying down), hives, itchy rash (urticaria), wheezing, or feeling sick or faint.
Croatian: • se u Vas javi stezanje u prsištu, omaglica (koja se javlja i nakon ustajanja iz sjedećeg ili ležećeg položaja), koprivnjača, osip praćen svrbežom (urtikarija), zviždanje u prsima, ili mučnina ili nesvjestica.
English: Place the product vial on an even and firm surface.
Croatian: Stavite bočicu s lijekom na ravnu i čvrstu površinu.
English: Iblias contains sodium
Croatian: Iblias sadrži natrij
English: • chest tightness/general feeling of being unwell
Croatian: • stezanje u prsištu/opće loše osjećanje
English: While the product vial is upright, connect the syringe to the Mix2Vial´s Luer Lock fitting by screwing clockwise.
Croatian: Dok bočica s lijekom stoji uspravno, spojite štrcaljku na luer lock nastavak Mix2Vial nastavka okrećući ju u smjeru kazaljke na satu.
English: EXP (End of the 12 month period, if stored up to 25 °C): ........... Do not use after this date.
Croatian: Rok valjanosti (kraj 12-mjesečnog razdoblja ako se lijek čuva na temperaturi do 25 °C): ...........
English: In this case, the product expires at the end of this 12-month period or the expiry date on the product vial, whichever is earlier.
Croatian: Rok valjanosti lijeka u tom slučaju ističe nakon tog razdoblja od 12 mjeseci ili nakon datuma isteka roka valjanosti navedenog na bočici s lijekom, ovisno o tome koji nastupi ranije.
English: This included published literature (SIPPET study6), data generated in individual clinical trials and a range of observational studies submitted by the marketing authorisation holders, including the data generated in large multicentre cohort studies, data submitted by the national competent authorities of the EU Member States as well as responses provided by the Authors of the SIPPET study.
Croatian: To obuhvaća objavljenu literaturu (ispitivanje SIPPET podatke izrađene u pojedinim kliničkim ispitivanjima i niz opservacijskih ispitivanja koje su dostavili nositelji odobrenja za stavljanje u promet, uključujući podatke izrađene u velikim