natgillin/translations-raw huggingface dataset:
Sanofi Pasteur - Parc Industriel d'Incarville - 27100 Val-de-Reuil - France Sanofi Pasteur, Campus Mérieux - 1541, avenue Marcel Mérieux - 69280 Marcy l'Etoile - France
Sanofi Pasteur, Parc Industriel d'Incarville, 27 100 Val-de-Reuil, Francuska Sanofi Pasteur, Campus Mérieux, 1541 avenue Marcel Mérieux, 69280 Marcy L`Etoile, Francuska
The vaccine may be administered to individuals of 60 years of age and over, especially in those who run an increased risk of associated complications.
Cjepivo se može primijeniti u odraslih osoba u dobi od 60 godina i više, a posebno u onih kod kojih postoji povećani rizik od komplikacija povezanih s gripom.
6.6 Special precautions for disposal and other handling Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Posebne mjere za zbrinjavanje i druga rukovanja lijekom Neiskorišten lijek ili otpadni materijal valja zbrinuti sukladno lokalnim propisima.
Prophylaxis of influenza in individuals 60 years of age and over, especially in those who run an increased risk of associated complications.
Prevencija influence u osoba u dobi od 60 godina i starijih, posebice u onih koji su pod povećanim rizikom od pojave komplikacija povezanih s influencom.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION IDflu 15 µg/strain 2016/2017
NAZIV GOTOVOG LIJEKA I PUT(EVI) PRIMJENE LIJEKA IDflu 15 µg/soj 2016/2017
** Seroconversion = negative pre-vaccination HI titre and post vaccination HI titre ≥ 40, Significant increase = positive pre-vaccination HI titre and at least a 4-fold increase in post-vaccination HI titre GMTR: Geometric mean titre ratio of individual (post-/pre-vaccination titre).
**serokonverzija = negativni prevakcinacijski HI titar i HI postvakcinacijski titar ≥40, Značajan porast = pozitivni prevakcinacijski HI titar i najmanje četverostruki porast u postvakcinacijskom HI
In this comparative trial the geometric mean titres (GMTs), seroprotection rate*, seroconversion or significant increase rate** and the geometric mean titre ratio (GMTR) for anti-HA antibody (measured by HI) were assessed according to predefined criteria.
U ovoj komparativnoj studiji srednji geometrijski titri (GMT), stopa seroprotekcije*, serokonverzije ili stopa značajnog porasta** te omjer geometrijskog srednjeg titra (GMTR) za anti-HA antitijela
Vasculitis associated in very rare cases with transient renal involvement
Vaskulitis je u vrlo rijetkim slučajevima povezan s prolaznim zahvaćanjem bubrega.
Other vaccines or medicines and IDflu Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
Obavijestite liječnika ili ljekarnika ako uzimate ili ste nedavno uzeli bilo koji drugi lijek.
It is not necessary to shake the vaccine before use.
Nije potrebno protresti cjepivo prije primjene.
• Pain located on the nerve route, convulsions associated with fever, nervous system disorders including inflammation of the brain or spinal cord or Guillain-Barré syndrome which causes
• Bol u području živčanih puteva, konvulzije (grčevi) povezane s vrućicom, neurološki poremećaji, uključujući upalu mozga ili kralježničke moždine ili Guillain-Barréov sindrom koji uzrokuje ekstremnu slabost i paralizu.
EU/1/08/507/004 - pack of 1 pre-filled syringe with a Micro-Injection System EU/1/08/507/005 - pack of 10 pre-filled syringes with a Micro-Injection System EU/1/08/507/006 - pack of 20 pre-filled syringes with a Micro-Injection System
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE GOTOVOG LIJEKA U PROMET EU/1/08/507/004 - pakiranje od 1 napunjene štrcaljke s mikroinjekcijskim sustavom EU/1/08/507/005 - pakiranje od 10 napunjenih štrcaljki s mikroinjekcijskim sustavom EU/1/08/507/006 - pakiranje od 20 napunjenih štrcaljki s mikroinjekcijskim sustavom
The other ingredients are: sodium chloride, potassium chloride, disodium phosphate dihydrate, potassium dihydrogen phosphate and water for injections.
Drugi sastojci su: natrijev klorid, kalijev klorid, natrijev hidrogenfosfat dihidrat, kalijev dihidrogenfosfat i voda za injekcije.
• Temporary reduction in the number of blood particles called platelets which can result in bruising or bleeding, temporary swelling of the glands in the neck, armpit or groin.
• Privremeno smanjenje broja određenih krvnih stanica zvanih krvne pločice, što može rezultirati stvaranjem modrica ili krvarenjem
Do not use this vaccine after the expiry date which is stated on the carton after EXP.
Ovo cjepivo se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na pakovanju iza „Rok valjanosti“ ili kratice „EXP“.
Very limited data in immunocompromised patients are available for IDflu.
Podaci o primjeni cjepiva IDflu u imunokompromitiranih pacijenata su ograničeni.
1 pre-filled syringe (0.1 ml) with a Micro-Injection System 10 pre-filled syringes (0.1 ml) with a Micro-Injection System 20 pre-filled syringes (0.1 ml) with a Micro-Injection System
1 napunjena štrcaljka (0,1ml) s mikroinjekcijskim sustavom 10 napunjenih štrcaljki (0,1ml) s mikroinjekcijskim sustavom 20 napunjenih štrcaljki (0,1ml) s mikroinjekcijskim sustavom
In a randomised comparative phase III trial, 398 subjects over 65 years of age received 0.1 ml of IDflu by intradermal route and 397 subjects over 65 years of age received 0.5 ml of a trivalent inactivated adjuvanted (MF-59 containing) influenza vaccine at the same dosage administered by intramuscular route.
Tijekom randomizirane komparativne studije faze III, 398 ispitanika starijih od 65 godina primilo je 0,1 ml cjepiva IDflu intradermalnim putem, a 397 ispitanika iste dobi primilo je 0,5 ml trovalentnog inaktiviranog adjuvantiranog (sadrži MF-59) cjepiva protiv influence u istoj dozi intramuskularnim putem.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Pre-filled syringe label text
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKOVANJE Tekst na naljepnici za napunjenu štrcaljku
C. OTHER CONDITIONS AND REQUIREMENTS OF THE
OSTALI UVJETI I ZAHTJEVI ZA STAVLJANJE
Talk to your doctor, pharmacist or nurse before using IDflu.
Upozorenja i mjere opreza Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego primijenite IDflu.
The vaccine should not be used if foreign particles are present in the suspension.
Cjepivo se ne smije primjeniti ukoliko su u suspenziji prisutne strane čestice.
• It is not necessary to shake the vaccine before use.
• Nije potrebno protresti cjepivo prije primjene.
5/ ACTIVATE NEEDLE SHIELD BY PUSHING FIRMLY ON PLUNGER
5/ AKTIVIRAJTE ŠTITNIK IGLE TAKO DA SNAŽNO PRITISNETE KLIP
1/ REMOVE NEEDLE CAP
1/ UKLONITE ZATVARAČ IGLE
Rare reactions (may affect up to 1 in 1000 people) - Tingling or numbness, inflammation of nerves, itching and rash.
Rijetke nuspojave (mogu se pojaviti najviše u 1 na 1000 osoba) - Trnci ili utrnulost, upala živaca, svrbež i osip.
The following side effects have been reported with other vaccines given to prevent flu.
Dolje navedene nuspojave prijavljivane su za ostala cjepiva protiv gripe.
• The vaccine should not be used if foreign particles are present in the suspension.
• Cjepivo se ne smije primijeniti ukoliko su u suspenziji prisutne strane čestice.
Tel dall'estero: +39 02 39394983
Tel: 800536389 Tel dall'estero: +39 02 39394983
- Other vaccines: IDflu can be given at the same time as other vaccines by using separate limbs.
- Druga cjepiva: IDflu se može primijeniti istovremeno s drugim cjepivima koja treba primijeniti na različitim udovima.
Allergic reactions including generalized skin reactions such as urticaria, anaphylactic reactions, angioedema, shock
Alergijske reakcije uključujući generalizirane reakcije kože kao što su urtikarija,
0.1 ml of suspension in a pre-filled syringe (glass) with a Micro-Injection System, with attached micro-needle, equipped with an elastomer plunger stopper (chlorobutyl), a tip cap (thermoplastic elastomer and polypropylene) and a needle shielding system.
Vrsta i sadržaj spremnika 0,1 ml suspenzije u napunjenoj štrcaljki (staklo) s mikroinjekcijskim sustavom, s pričvršćenom mikroiglom, opremljenom s elastomernim čepom klipa (klorobutil), zatvaračem vrha (termoplastični elastomer i polipropilen) i sustavom zaštite za iglu.
Data were as follows (values in brackets show the 95% confidence intervals):
Podaci su sljedeći (vrijednosti u zagradi pokazuju 95% interval pouzdanosti): Intradermalna primjena 15μg A/H3N2
MARKETING AUTHORISATION HOLDER Sanofi Pasteur SA, 2, avenue Pont Pasteur, F-69007 Lyon, France.
Nositelj odobrenja: Sanofi Pasteur SA, 2, avenue Pont Pasteur, F-69007 Lyon, Francuska.
The duration of postvaccinal immunity to homologous strains or to strains closely related to the vaccine strains varies but is usually
Nakon cijepljenja trajanje imuniteta na homologne sojeve ili sojeve usko srodne sojevima u cjepivu je različito, ali obično traje 6-12 mjeseci.
This vaccine complies with the WHO recommendations (Northern Hemisphere) and EU decision for
Ovo cjepivo odgovara preporuci SZO (sjeverna hemisfera) i odluci EU za sezonu 2016/2017.
The data below summarizes the frequencies of the adverse reactions that were recorded following vaccination during clinical trials and worldwide post-marketing experience, using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1000); very rare (<1/10,000), not known (cannot be estimated from available data).
vrlo često ( ≥ 1/10); često ( ≥ 1/100 do < 1/10); manje često ( ≥ 1/1 000 do < 1/100); rijetko ( ≥ 1/10
4.7 Effects on ability to drive and use machines IDflu has no or negligible influence on the ability to drive and use machines.
IDflu ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada na strojevima.
The Western Blot technique disproves the false-positive ELISA test results.
Blot metodom se opovrgavaju takvi prolazni lažno pozitivni rezultati ELISA testa koji mogu biti posljedica IgM odgovora potaknutog cijepljenjem.
Immunisation should be carried out by intradermal route.
Cjepivo se primjenjuje intradermalno.
The Micro-Injection System for intradermal injection consists of a pre-filled syringe with a micro-needle (1.5 mm) and a needle shielding system.
Mikroinjekcijski sustav za primjenu u kožu sastoji se od napunjene štrcaljke s mikroiglom (1,5 mm) i sustava zaštite za iglu.
MARKETING AUTHORISATION NUMBER(S) EU/1/08/507/004
BROJ(EVI) ODOBRENJA ZA STAVLJANJE GOTOVOG LIJEKA U PROMET EU/1/08/507/004
As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of an anaphylactic event following the administration of the vaccine (see
Kao i kod svih cjepiva koja se injiciraju, odgovarajući medicinski nadzor i liječenje trebaju uvijek biti odmah dostupni u slučaju anafilaksije nakon primjene cjepiva (vidjeti dio 4.8).
In a pivotal randomised comparative phase III trial, 2,606 subjects over 60 years of age received 0.1 ml of IDflu by intradermal route and 1,089 subjects over 60 years of age received 0.5 ml of a trivalent inactivated influenza vaccine administered by intramuscular route.
Tijekom randomizirane komparativne pivotalne studije faze III 2606 osoba starijih od 60 godina primilo je 0,1 ml cjepiva IDflu intradermalnim putem, a 1089 ispitanika iste dobi primilo je 0,5 ml trovalentnog inaktiviranog cjepiva protiv influence intramuskularno.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Pack of 1 or 10 or 20 pre-filled syringe(s) with a Micro-Injection System
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKOVANJU Pakovanje od 1,10 ili 20 napunjenih štrcaljki s mikroinjekcijskim sustavom
A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
PROIZVOĐAČ(I) BIOLOŠKE DJELATNE TVARI I PROIZVOĐAČ(I) ODGOVORNI ZA PUŠTANJE SERIJE
Not applicable
Nije primijenjivo.
Uncommon reactions (may affect up to 1 in 100 people) - Tiredness, joint pain and increased sweating.
Manje česte nuspojave (mogu se pojaviti najviše u 1 na 100 osoba) - Umor, bol u zglobovima i povećano znojenje.
Hypersensitivity to the active substances, to any of the excipients listed in section 6.1, or to any residues such as eggs (ovalbumin, chicken proteins), neomycin, formaldehyde and octoxinol 9.
4.3. Kontraindikacije Preosjetljivost na djelatne tvari, neku od pomoćnih tvari navedenih u dijelu 6.1. ili ostatne tvari kao što su jaja (ovalbumin i bjelančevine pilećeg porijekla) neomicin, formaldehid i oktoksinol 9.
Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder: Sanofi Pasteur SA, 2, avenue Pont Pasteur, F-69007 Lyon, France.
NOSITELJ ODOBRENJA ZA STAVLJANJE GOTOVOG LIJEKA U PROMET Sanofi Pasteur SA, 2, avenue Pont Pasteur, F-69007 Lyon, Francuska.
Sodium chloride, potassium chloride, disodium phosphate dihydrate, potassium dihydrogen
Natrijev klorid, kalijev klorid, natrijev hidrogenfosfat dihidrat, kalijev dihidrogenfosfat, voda za
Common reactions (may affect up to 1 in 10 people) - Bruising at the injection site.
Česte nuspojave (mogu se pojaviti najviše u 1 na 10 osoba) - Modrica na mjestu primjene.
Across all three influenza strains, for the comparator intramuscular vaccine GMTs ranged between 34.8 (1/dil) and 181.0 (1/dil), seroprotection rates ranged between 48.9% and 87.9%, seroconversion or significant increase rates ranged between 30.0% and 46.9% and GMTRs ranged between 3.04 and 5.35-fold over baseline HI titres.
48,9% i 87,9%, serokonverzija ili stope značajne porasta bile su između 30,0% i 46,9 %, dok su
NAME OF THE MEDICINAL PRODUCT IDflu 15 microgram/strain, suspension for injection Influenza vaccine (split virion, inactivated) Strains 2016/2017
NAZIV GOTOVOG LIJEKA IDflu 15 mikrograma/soj suspenzija za injekciju Cjepivo protiv influence (fragmentirani virion, inaktivirano) Sojevi 2016/2017
In case of presence of liquid at the injection site after vaccine administration, re-vaccination is not
Ukoliko nakon primjene cjepiva ostane tekućine na mjestu injiciranja, nije potrebno ponoviti
IDflu is a suspension for injection in a pre-filled syringe of 0.1 ml with a Micro-Injection System in
IDflu je suspenzija za injekciju u napunjenoj štrcaljki od 0,1 ml s mikroinjekcijskim sustavom u pakovanjima od 1, 10 ili 20.
After repetitive yearly injections the safety profile of IDflu is similar to the previous injections.
Nakon ponavljane sezonske primjene, sigurnosni profil IDflu-a sličan je onom dobivenom pri b. tabelarni sažeti prikaz nuspojava
Antibody response in patients with endogenous or iatrogenic immunosuppression may be insufficient.
Kod bolesnika s endogenom ili jatrogenom imunosupresijom imunološki odgovor može biti
Check with your doctor or
Provjerite sa svojim liječnikom ili ljekarnikom ako niste sigurni.
This vaccine is intended for individuals 60 years of age and over.
Ovo cjepivo je namijenjeno osobama u dobi od 60 godina i starijima, stoga ove informacije nisu
NAME OF THE MEDICINAL PRODUCT IDflu 15 microgram/strain suspension for injection Influenza vaccine (split virion, inactivated)
NAZIV GOTOVOG LIJEKA IDflu 15 mikrograma/soj, suspenzija za injekciju Cjepivo protiv influence (fragmentirani virion, inaktivirano)
(immunosuppression) due to disease or medicines, because the vaccine may not work very well in this case.
- Prije cijepljenja trebali bi obavijestiti liječnika ukoliko imate smanjen imunološki odgovor (imunosupresiju) uzrokovan bolešću ili uzimanjem lijekova jer u tom slučaju cjepivo možda neće biti učinkovito.
- If, for any reason, you have a blood test within a few days following an influenza vaccination, please tell your doctor.
Ako ćete, iz bilo kojeg razloga raditi krvne pretrage unutar nekoliko dana nakon cijepljenja protiv gripe, obavijestite svog liječnika jer to može utjecati na rezultate testova za HIV-1, hepatitis C i HTLV-1.
If you have any further questions on the use of this vaccine, ask your doctor, pharmacist or nurse.
U slučaju bilo kakvih nejasnoća ili pitanja u vezi s primjenom ovog cjepiva, obratite se svom liječniku, ljekarniku ili medicinskoj sestri.
Transient thrombocytopenia, transient lymphadenopathy
Prolazna trombocitopenija, prolazna limfadenopatija.
In this case, the
Što se nalazi u ovoj uputi:
2/ HOLD MICRO-INJECTION SYSTEM BETWEEN THUMB & MIDDLE FINGER
2/ DRŽITE MIKROINJEKCIJSKI SUSTAV
With the same hand, push very firmly with the thumb on the plunger to activate the You hear a click and a shield comes out to cover the needle.
Istom rukom u kojoj ju držite, snažno pritisnite klip palcem kako bi aktivirali
The immunological response may be diminished if the patient is undergoing immunosuppressant
Kod bolesnika na imunosupresivnoj terapiji moguć je smanjen imunološki odgovor.
It should be noted that the side effects may be intensified.
Treba napomenuti da istovremena primjena s drugim cjepivima može pojačati nuspojave.
Injection is considered successful whether or not the presence of a wheal is In case of presence of liquid at the injection site after vaccine administration, re
Injiciranje se smatra uspješnim bez obzira da li je na mjestu injiciranja
During clinical trials and after the vaccine came on the market, the following side effects were reported with the use of IDflu.
• Koprivnjača i poteškoće u disanju Kod primjene IDflu-a u kliničkim ispitivanjima i praćenjem nakon stavljanja cjepiva na tržište zabilježene su dolje navedene nuspojave.
QUALITATIVE AND QUANTITATIVE COMPOSITION Influenza virus (inactivated, split) of the following strains*: A/California/7/2009 (H1N1)pdm09 - like strain (A/California/7/2009, NYMC X-179A) .............................................................................................................................. 15 micrograms HA** A/Hong Kong/4801/2014 (H3N2) - like strain (A/Hong Kong/4801/2014, NYMC X-263B) .............................................................................................................................. 15 micrograms HA** B/Brisbane/60/2008 - like strain (B/Brisbane/60/2008, wild type) ..................... 15 micrograms HA**
Djelatna tvar je virus influence (inaktiviran, fragmentiran) sljedećih sojeva*: A/California/7/2009 (H1N1)pdm09 - sličan soj (A/California/7/2009, NYMC X-179A) ............................................................................................................................. 15 mikrograma HA**
IDflu is as immunogenic as the comparator trivalent adjuvanted (MF-59 containing) vaccine in terms of GMT for each of the 3 influenza strains with the SRH method and for 2 strains with the HI method.
Kada govorimo o GMT-u određenom SRH metodom za sva tri soja, te HI metodom za dva soja, IDflu je imunogen kao i komparativno trovalentno adjuvantirano (sadrži MF-59) cjepivo.
The active substances are Influenza virus (inactivated split) of the following strains*: A/California/7/2009 (H1N1)pdm09 - like strain (A/California/7/2009, NYMC X-179A) .............................................................................................................................. 15 micrograms HA** A/Hong Kong/4801/2014 (H3N2) - like strain (A/Hong Kong/4801/2014, NYMC X-263B) .............................................................................................................................. 15 micrograms HA** B/Brisbane/60/2008 - like strain (B/Brisbane/60/2008, wild type) ..................... 15 micrograms HA**
A/California/7/2009 (H1N1)pdm09 - sličan soj (A/California/7/2009, NYMC X-179A) ............................................................................................................................. 15 mikrograma HA**
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
11. IME I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE GOTOVOG LIJEKA U
Influenza virus (inactivated, split) of the following strains: A/California/7/2009 (H1N1)pdm09 - like strain A/Hong Kong/4801/2014 (H3N2) - like strain
A/Hong Kong/4801/2014 (H3N2) - sličan soj (A/Hong Kong/4801/2014, NYMC X-263B)
The recommended dose is 0.1 ml for individuals 60 years of age and over.
Za odrasle osobe u dobi od 60 godina i starije preporučena doza je 0,1 ml cjepiva.
IDflu is at least as immunogenic as the comparator trivalent inactivated influenza vaccine administered by intramuscular route for each of the 3 influenza strains in subjects from 60 years of
GMTR: omjer srednjeg geometrijskog titra pojedinca (post-/pre vakcinacijski titar) Kod ispitanika u dobi od 60 godina i starijih u slučaju sva tri soja cjepivo IDflu je u komparaciji s trovalentnim inaktiviranim cjepivom protiv influence koje se primjenjuje intramuskularnim putem pokazalo najmanje istu imunogenost.
These side
Pogledajte dio
• The Micro-Injection System for intradermal injection consists of a pre-filled syringe with a micro-needle (1.5 mm) and a needle shielding system.
• Mikroinjekcijski sustav za primjenu u kožu sastoji se od napunjene štrcaljke s mikroiglom
HOW TO USE IDflu
Vidjeti također dio 3. KAKO PRIMJENJIVATI IDflu
Remove the needle cap from the
Uklonite zatvarač igle s mikroinjekcijskog sustava
Package leaflet: Information for the user
Sadržaj pakovanja i dodatne informacije
b. Tabulated summary of adverse reactions
• Periodička izvješća o neškodljivosti
* Relative potency (mice potency test) compared to a reference vaccine that was shown efficacious in the target animal species.
* Relativna potencija (test potencije na miševima) u usporedbi s referentnim cjepivom koje je pokazalo djelotvornost u ciljnih vrsta životinja
Inactivated Schmallenberg virus, strain BH80/11-4: ≥ 1 RP*/2 ml (for cows) or ≥ 1 RP*/ml (for sheep).
Inaktivirani virus Schmallenberg, soj BH80/11-4: ≥ 1 RP*/2 ml (za krave) ili ≥ 1 RP*/ml (za ovce).
Intramuscular use or subcutaneous use.
Goveda i ovce Intramuskularna ili supkutana upotreba
Vial (HDPE) 50 ml
50 ml
The Agency issued its opinion on 17 October 2019.
Agencija je objavila mišljenje 17. listopada 2019.
Vanflyta was compared with other
Vanflyta je uspoređen s drugim
What is Vanflyta and what was it intended to be used for?
Što je Vanflyta i za što se trebao koristiti?
The company that applied for authorisation, Daiichi Sankyo Europe GmbH, may ask for re-examination of the opinion within 15 days of receiving the opinion.
Tvrtka koja je podnijela zahtjev za izdavanje odobrenja, Daiichi Sankyo Europe GmbH, može zatražiti preispitivanje mišljenja u roku od 15 dana od primitka ovog mišljenja.
Further information on the orphan designation can be found on the Agency's website: ema.europa.eu/medicines/human/orphan-designations/eu309622.
Dodatne informacije o uvrštenju lijekova za rijetke bolesti dostupne su na internetskim stranicama Agencije: ema.europa.eu/medicines/human/orphan-designations/eu309622.
What were the main reasons for refusing the marketing authorisation?
Koji su bili glavni razlozi za odbijanje odobrenja za stavljanje lijeka u promet?
How does Vanflyta work?
Kako djeluje Vanflyta?
18 October 2019 EMA/559309/2019 EMEA/H/C/004468
EMA/559309/2019 EMEA/H/C/004468
If you are in a clinical trial or compassionate use programme and need more information about your treatment, speak with your clinical trial doctor.
Ako sudjelujete u kliničkom ispitivanju ili programu milosrdnog davanja lijekova te vam je potrebno više informacija o liječenju, obratite se liječniku koji vas liječi.
cancer medicines and the main measure of effectiveness was overall survival (how long patients lived) after being given Vanflyta or the comparator medicines.
lijekovima protiv raka, a glavno mjerilo učinkovitosti bilo je ukupno preživljenje (koliko su dugo bolesnici živjeli) nakon primjene lijeka Vanflyta ili usporednih lijekova.
Does this refusal affect patients in clinical trials or compassionate use programmes?
Ima li ovo odbijanje zahtjeva posljedice za bolesnike u kliničkim ispitivanjima ili u programima milosrdnog davanja lijekova?
Refusal of the marketing authorisation for Vanflyta (quizartinib) EMA/559309/2019
Odbijanje odobrenja za stavljanje u promet lijeka Vanflyta (kvizartinib) EMA/559309/2019
The company presented the results of a study in 367 patients with FLT3-ITD positive AML whose disease did not respond to treatment or came back after treatment.
Tvrtka je dostavila rezultate ispitivanja provedenog na 367 bolesnika s AML-om pozitivnim na FLT3-ITD u kojih bolest nije reagirala na liječenje ili se vratila nakon liječenja.