natgillin/translations-raw huggingface dataset:
The anti-hepatitis B surface antigen (anti-HBs) and anti-hepatitis A virus (anti-HAV) antibody titres observed following a primary vaccination course with Ambirix are in the range of what is seen following vaccination with the monovalent hepatitis A and B vaccines.
Titri protutijela protiv površinskog antigena hepatitisa B (anti-HBs) i protiv virusa hepatitisa A (antiHAV) zapaženi nakon primarnog ciklusa cijepljenja cjepivom Ambirix u rasponu su titara viđenih nakon cijepljenja monovalentnim cjepivima za hepatitis A i B.
Exceptionally, the vaccine may be administered subcutaneously in patients with thrombocytopenia or bleeding disorders.
Iznimno se cjepivo može primijeniti supkutano u bolesnika s trombocitopenijom ili poremećajima hemostaze krvi.
In clinical studies involving subjects from 1 year up to and including 15 years old, seropositivity rates for anti-HAV antibodies were 99.1% one month after the first dose and 100% after the second dose given at month 6 (i.e month 7).
U kliničkim ispitivanjima na ispitanicima u dobi od 1 do uključujući 15 godina, stope seropozitivnosti za anti-HAV protutijela su bile 99,1% mjesec dana nakon primitka prve doze, te 100% nakon primitka druge doze u 6. mjesecu (tj. u 7. mjesecu).
How to store Ambirix
Kako čuvati Ambirix
Local and general adverse reactions reported following primary vaccination with Ambirix were categorised by frequency.
Lokalne i opće nuspojave koje su prijavljene nakon primarnog cijepljenja cjepivom Ambirix kategorizirane su prema učestalosti pojavljivanja.
Seropositivity rates for anti-HBs antibodies were 74.2% one month after the first dose and 100% after the second dose given at month 6 (i.e. month 7).
Mjesec dana nakon primitka prve doze stope seropozitivnosti za anti-HBs protutijela su iznosile 74,2%, te 100% nakon primitka druge doze u 6. mjesecu (tj. u 7. mjesecu).
Ask your doctor, nurse or pharmasist if you are not sure.
Provjerite sa svojim liječnikom, medicinskom sestrom ili ljekarnikom ako niste sigurni.
Side effects that occurred during routine use of Ambirix were as follows:
Nuspojave koje su se pojavile tijekom rutinske primjene cjepiva Ambirix bile su sljedeće:
Ambirix should only be used during breast-feeding when the possible advantages outweigh the potential risks.
Ambirix se u dojilja smije primijeniti samo onda kada moguće koristi liječenja nadmašuju moguće rizike.
In haemodialysis patients and persons with an impaired immune system, adequate anti-HAV and anti-HBs antibody titers may not be obtained after the primary immunisation course.
Može se dogoditi da se u bolesnika na hemodijalizi, te bolesnika s poremećajem imunološkog sustava ne postignu dostatni titrovi anti-HAV i anti-HBs nakon primarne imunizacije.
However, exceptionally Ambirix can be administered subcutaneously to subjects with thrombocytopenia or bleeding disorders since bleeding may occur following an intramuscular administration to these subjects.
Ipak, iznimno se cjepivo Ambirix može primijeniti potkožno u bolesnika s trombocitopenijom ili poremećajima hemostaze krvi, jer nakon primjene u mišić u tih osoba može doći do krvarenja.
Concomitant administration of Ambirix and other vaccines than those listed above has not been studied.
Istovremena primjena cjepiva Ambirix i drugih cjepiva, osim ranije navedenih, nije bila ispitivana.
The need for a booster dose of hepatitis B vaccine in healthy individuals who have received a full primary vaccination course has not been established.
Nije ustanovljeno treba li docjepljivanje protiv hepatitisa B zdravim osobama koje su završile primarni ciklus cijepljenja.
This means you may not be protected against one or both of the hepatitis A and B viruses.
što znači da možda nećete biti zaštićeni od virusa hepatitisa A i/ili B.
At 6 years following the initiation of a 0, 6 month or a 0, 12 month schedule of Ambirix in children aged 12-15 years all subjects followed up retained ≥15 mIU/ml anti-HAV antibody.
Šest godina nakon primjene cjepiva Ambirix po rasporedu 0, 6 mjeseci ili 0, 12 mjeseci u djece između 12 i 15 godina, svi ispitanici koji su praćeni zadržali su titar ≥15 mIU/ml anti-HAV protutijela.
≥ 1/1,000 to < 1/100
≥ 1/1000 do < 1/100
When the first dose of Ambirix was administered concomitantly with a booster dose of a combined diphtheria, tetanus, acellular pertussis, inactivated poliomyelitis and Haemophilus influenzae type b vaccine (DTPa-IPV+Hib) or with the first dose of a combined Measles-Mumps-Rubella vaccine in the second year of life, immune responses to all antigens were satisfactory.
Pri istovremenoj primjeni prve doze cjepiva Ambirix s dodatnom (booster) dozom kombiniranog cjepiva protiv difterije, tetanusa, acelularnog pertusisa, dječje paralize (inaktivirano) i Haemophilus influenzae tipa b (DTPa-IPV+Hib) ili s prvom dozom kombiniranog cjepiva protiv ospica, zaušnjaka i rubeole u drugoj godini života, postignut je zadovoljavajući imunološki odgovor na sve antigene.
Detailed information on this 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
If rapid protection against hepatitis B is required, the standard three dose regimen of the combined vaccine containing 360 ELISA Units of formalin inactivated hepatitis A virus and 10 micrograms of recombinant hepatitis B surface antigen is recommended.
Ako je potrebna brza zaštita protiv hepatitisa B, preporuča se standardni režim od tri doze kombiniranim cjepivom koje sadrži 360 ELISA jedinica virusa hepatitisa
• feeling tired or irritable
• umor i razdražljivost
• disease of the nerves of the eyes (optic neuritis)
• upala živaca (neuritis) • bolest očnih živaca (optički neuritis)
It is possible that subjects may be in the incubation period of a hepatitis A or hepatitis B infection at the time of vaccination.
Moguće je da osobe u vrijeme cijepljenja budu u periodu inkubacije hepatitisa
They may be very tired, and have dark urine, pale faeces, yellowish skin or eyes (jaundice).
Mogu se osjećati veoma umorno i imati tamnu mokraću, blijedo lice te žućkastu boju kože ili očiju (žutica).
• you have previously had an allergic reaction to any vaccine against hepatitis A or hepatitis B diseases
• ako ste imali alergijsku reakciju nakon prethodne primjene bilo kojeg cjepiva protiv hepatitisa
The most commonly reported adverse reactions following Ambirix administration are pain and fatigue occurring in an approximated per dose frequency of 50% and 30% respectively.
Najčešće prijavljene nuspojave nakon primjene cjepiva Ambirix uključuju bol i opću slabost koje se javljaju s učestalošću od približno 50% odnosno 30% po dozi cjepiva, a prema redu navođenja.
Since intradermal injection or intramuscular administration into the gluteal muscle could lead to a suboptimal response to the vaccine, these routes should be avoided.
Treba izbjegavati intradermalnu ili intramuskularnu primjenu u glutealni mišić jer ti putevi primjene mogu rezultirati suboptimalnim odgovorom na cjepivo.
• upper airway infections
• infekcije gornjih dišnih putova
• aching muscles (myalgia)
• bol u mišićima (mialgija)
However, this route of administration may result in suboptimal immune response to the vaccine.
Međutim, ovaj put primjene može rezultirati suboptimalnim imunološkim odgovorom na cjepivo (vidjeti dio 4.4).
The anti-HBs seroprotection rates (titers ≥ 10 mlU/ml) at these time points were 37.4% and 98.2% respectively.
Stope seroprotekcije za anti-HBs protutijela (titri ≥10 mlU/ml) u istim vremenskim periodima su iznosile 37,4% odnosno 98,2%, prema redoslijedu navođenja.
LIST OF EXCIPIENTS Sodium chloride Water for injections
natrijev klorid voda za injekcije
• swollen glands in the neck, armpit or groin (lymphadenopathy)
• otečene žlijezde na vratu, ispod pazuha ili u preponama (limfadenopatija)
1Produced on human diploid (MRC-5) cells 2Adsorbed on aluminium hydroxide, hydrated
1umnožen na ljudskim diploidnim (MRC-5) stanicama 2adsorbiran na aluminijev hidroksid, hidratizirani
In a clinical study, 102 subjects aged from 12 years up to and including 15 years received the second dose of Ambirix at month 12.
cjepivo (360/10) U kliničkom ispitivanju, 102 ispitanika u dobi od 12 do uključujući 15 godina primilo je drugu dozu cjepiva Ambirix u 12. mjesecu.
• itching (pruritus), rash
• svrbež (pruritus), osip
No data on concomitant administration of Ambirix with specific hepatitis A immunoglobulin or hepatitis B immunoglobulin have been generated.
Ne postoje podaci o istovremenoj primjeni cjepiva Ambirix i specifičnih imunoglobulina protiv hepatitisa
• reaction where the injection was given
• oticanje na mjestu primjene injekcije
• Clinical trial data
• Podaci iz kliničkih ispitivanja
• If you/your child gets any side effects, talk to your doctor, nurse or pharmacist.
• Ako Vi/Vaše dijete primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika, medicinsku sestru ili ljekarnika.
• pins and needles (paraesthesia)
• trnci i bockanje (parestezija)
In both studies, subjects received either a two dose schedule of Ambirix or a three dose regimen of the combined vaccine containing 360 ELISA Units of formalin inactivated hepatitis A virus and 10 micrograms of recombinant hepatitis B surface antigen.
U oba ispitivanja, ispitanici su primili ili dvije doze cjepiva Ambirix ili režim od tri doze kombiniranog cjepiva koje sadrži 360 ELISA jedinica virusa hepatitisa
A dose of 1.0 ml is recommended for subjects from 1 year up to and including 15 years of age.
Za osobe u dobi od jedne godine do uključivo 15 godina života preporučuje se doza od 1,0 ml.
Inspect the vaccine again: a. If the vaccine appears as a uniform hazy white suspension, it is ready to use - the appearance should not be clear.
Ako cjepivo izgleda kao jednolično mutno bijela suspenzija, spremno je za primjenu izgled ne smije biti bistar.
• They will take care that Ambirix is not given into a vein.
• Liječnik ili medicinska sestra vodit će računa o tome da se Ambirix ne injicira u venu.
PHARMACEUTICAL FORM AND CONTENTS Suspension for injection in pre-filled syringe 1 pre-filled syringe
Suspenzija za injekciju u napunjenoj štrcaljki 1 napunjena štrcaljka
It is not yet fully established whether immunocompetent individuals who have responded to hepatitis A vaccination will require booster doses as protection in the absence of detectable antibodies may be ensured by immunological memory.
Još nije u potpunosti utvrđeno treba li imunokompetentnim osobama koje su odgovorile na cijepljenje cjepivom protiv hepatitisa
3Produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology 4Adsorbed on aluminium phosphate
3proizveden tehnologijom rekombinantne DNA na stanicama kvasca (Saccharomyces cerevisiae) 4adsorbiran na aluminijev fosfat
The following adverse reactions were reported during post-marketing surveillance following vaccination with Ambirix.
Sljedeće nuspojave zabilježene su tijekom praćenja primjene cjepiva Ambirix nakon stavljanja cjepiva u promet.
Very common (These may occur with more than 1 in 10 doses of the vaccine) :
Vrlo često (One se mogu javiti u više od 1 na 10 doza cjepiva):
In situations where a booster dose of hepatitis A and/or hepatitis B is desired, a monovalent or combined vaccine can be given.
A i/ili hepatitisa B, mogu se primijeniti monovalentno ili kombinirano cjepivo.
Syncope (fainting) can occur following, or even before, any vaccination especially in adolescents as a psychogenic response to the needle injection.
Kao psihogeni odgovor na ubod injekcijom, osobito u adolescenata, nakon ili čak i prije bilo kojeg cijepljenja može doći do sinkope (gubitka svijesti).
Read the package leaflet before use Intramuscular use Shake well before use
Prije uporabe pročitajte Uputu o lijeku
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Za sve informacije o ovom lijeku obratite se lokalnom predstavniku nositelja odobrenja za stavljanje gotovog lijeka u promet: België/Belgique/Belgien
Hepatitis A virus (inactivated)1,2
1 doza (1 ml): inaktivirani virus hepatitisa A1,2
• you need to be fully protected against hepatitis A and B infection within the next 6 monthsyour doctor may recommend a different vaccine
• ako morate biti potpuno zaštićeni od infekcije virusom hepatitisa A i B unutar sljedećih
Rare (These may occur with up to 1 in 1,000 doses of the vaccine) :
Rijetko (One se mogu javiti u do 1 na 1000 doza cjepiva):
How the injection is given
Kako se daje Ambirix Kako se daje injekcija
Nederland GlaxoSmithKline BV
GlaxoSmithKline BV
Blood and lymphatic system disorders Rare: lymphadenopathy
Manje često: infekcije gornjih dišnih puteva Poremećaji krvi i limfnog sustava Rijetko: limfadenopatija
- Booster dose
- Doza za docjepljivanje
It is found in body fluids such as blood, semen, vaginal secretions, or saliva (spit).
sjemena tekućina, vaginalni sekret ili slina (ispljuvak).
In a comparative clinical trial conducted among subjects aged from 12 years up to and including 15 years of age, 142 received two doses of Ambirix and 147 received the standard three-dose combined vaccine.
142 ispitanika je primilo dvije doze cjepiva Ambirix, a 147 ispitanika standardno kombinirano cjepivo u tri doze.
Gastrointestinal disorders Common: diarrhoea, nausea Uncommon: vomiting, abdominal pain*
Često: proljev, mučnina Manje često: povraćanje, bolovi u trbuhu*
Ambirix confers immunity against HAV and HBV infection by inducing specific anti-HAV and antiHBs antibodies.
potičući stvaranje specifičnih anti-HAV i anti-HBs protutijela.
NAME OF THE MEDICINAL PRODUCT Ambirix suspension for injection in pre-filled syringe Hepatitis A (inactivated) and hepatitis B (rDNA) (HAB) vaccine (adsorbed).
Ambirix suspenzija za injekciju u napunjenoj štrcaljki Cjepivo protiv hepatitisa A (inaktivirano) i hepatitisa B (rDNA) (HAB), adsorbirano.
GlaxoSmithKline Kft. Tel.: + 36-1-2255300
Tel.: + 36-1-2255300
Musculoskeletal and connective tissue disorders Arthritis, muscular weakness
Artritis, mišićna slabost
Tel: + 49 (0)89 360448701 produkt.info@gsk.com
Tel: + 49 (0)89 360448701
• fits or seizures
• želučane i probavne tegobe
* refers to adverse reactions observed in clinical trials performed with the paediatric formulation
Rijetko: zimica, bolest slična gripi * odnosi se na nuspojave zabilježene u kliničkim ispitivanjima provedenim s pedijatrijskom formulacijom • Podaci prikupljeni nakon stavljanja cjepiva u promet
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1 dose (1 ml)
SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA
1-5 yrs old
od 1-5 godina
This includes any possible side effects not listed in this leaflet.You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Nuspojave možete prijaviti izravno putem nacionalnog sustava za prijavu nuspojava navedenog u Dodatku V*.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Ambirix, suspension for injection
Uputa o lijeku: Informacija za korisnika Ambirix suspenzija za injekciju u napunjenoj štrcaljki
NAME OF THE MEDICINAL PRODUCT Ambirix - Suspension for injection in pre-filled syringe Hepatitis A (inactivated) and hepatitis B (rDNA) (HAB) vaccine (adsorbed)
Ambirix suspenzija za injekciju u napunjenoj štrcaljki Cjepivo protiv hepatitisa A (inaktivirano) i hepatitisa B (rDNA) (HAB), adsorbirano
Additional side effects that occurred during routine use of very similar combined or individual hepatitis A and hepatitis B vaccines were as follows:
• gubitak osjetljivosti kože na bol ili dodir (hipoestezija) Dodatne nuspojave koje su se javile tijekom rutinske primjene vrlo sličnih kombiniranih ili pojedinačnih cjepiva za hepatitis A i hepatitis B bile su sljedeće:
• purple or reddish-purple bumps on the skin (lichen planus), serious skin rashes (erythema multiforme)
• ljubičaste ili crvenoljubičaste izbočine na koži (lichen planus), ozbiljni kožni osipi (multiformni eritem) • smanjenje broja krvnih pločica (trombocita), što povećava rizik od krvarenja ili nastanka modrica
General disorders and administration site conditions Immediate injection site pain, stinging and burning sensation
Opći poremećaji i reakcije na mjestu primjene Trenutna bol na mjestu primjene, osjećaj probadanja i pečenja
GlaxoSmithKline S.p.A. Tel: + 39 04 59 21 81 11
ГлаксоСмитКлайн ЕООД Тел.: + 359 2 953 10 34
Protection against hepatitis B infections may not be obtained until after the second dose (see section Therefore: - Ambirix should be used only when there is a relatively low risk of hepatitis B infection during the vaccination course.
Zaštita protiv infekcija hepatitisom B možda se neće postići prije primitka druge doze (vidjeti dio 5.1).
Laboratoire GlaxoSmithKline Tél: + 33 (0) 1 39 17 84 44 diam@gsk.com
Tél: + 33 (0) 1 39 17 84 44
Hypersensitivity after previous administration of hepatitis A and/or hepatitis B vaccines.
Preosjetljivost nakon prethodne primjene cjepiva protiv hepatitisa
The latter contained 360 ELISA Units of formalin inactivated hepatitis A virus and 10 micrograms of recombinant hepatitis B surface antigen.
A inaktiviranog formalinom i 10 mikrograma rekombinantnog površinskog antigena hepatitisa B.
Side effects that occurred during clinical trials with Ambirix were as follows:
Tijekom kliničkog ispitivanja cjepiva Ambirix pojavile su se sljedeće nuspojave:
Ambirix Combined HAB vaccine (360/10)
Ambirix Kombinirano HAB
Skin and subcutaneous tissue disorders Erythema multiforme, lichen planus
Erythema multiforme, lichen planus Poremećaji mišićno-koštanog sustava i vezivnog tkiva
In addition, the following adverse reactions were reported during clinical trials with GlaxoSmithKline's other combined hepatitis A and hepatitis B vaccines (given as a 3 or 4 dose schedule)
A i hepatitisa B tvrtke GlaxoSmithKline (primijenjenih po rasporedu cijepljenja 3 ili 4 doze), prijavljene su sljedeće nuspojave
50 x 1 dose (1 ml)
50 napunjenih štrcaljki 50 x 1 doza (1 ml)
Posology
Cjepivo
• swelling or infection of the brain (encephalitis)
• poremećaj u nalazima pretraga koje se odnose na rad jetre • oticanje ili infekcija mozga (encefalitis)
Concomitant immunoglobulin administration may result in lower antibody titres.
Takva primjena može rezultirati nižim titrima protutijela.
Tel: + 31 (0)30 69 38 100 nlinfo@gsk.com
Tel: + 31 (0)30 69 38 100
Blood and lymphatic system disorders Thrombocytopenic purpura, thrombocytopenia
Trombocitopenična purpura, trombocitopenija
General disorders and administration site conditions Very common: fatigue, pain and redness at the injection site Common: fever, swelling at the injection site
Opći poremećaji i reakcije na mjestu primjene Vrlo često: umor, bolnost i crvenilo na mjestu primjene
The vaccine should be re-suspended following the steps below.
Resuspendiranje cjepiva kako bi se dobila jednolična mutno bijela suspenzija Cjepivo se treba resuspendirati slijedeći korake opisane ispod: 1.
GlaxoSmithKline (GSK) SRL Tel: + 40 (0)21 3028 208
Tel: + 40 (0)21 3028 208
3Produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology 4Adsorbed on aluminium phosphate,
0,05 miligrama Al3+ 3proizveden tehnologijom rekombinantne DNA na stanicama kvasca (Saccharomyces cerevisiae) adsorbiran na aluminijev fosfat,
Anti-HBs Month 7 SP (%)
7. mjesec SP (%)
Cases of overdose with GlaxoSmithKline's combined hepatitis A and hepatitis B vaccine have been reported during post-marketing surveillance.
4.9 Predoziranje Tijekom praćenja nakon stavljanja cjepiva u promet zabilježeni su slučajevi predoziranja kombiniranim cjepivom protiv hepatitisa A i hepatitisa B tvrtke GlaxoSmithKline.
Anti-HBs Month 6 SP (%)
6. mjesec SP (%)
Anti-HBs Month 2 SP (%)
2. mjesec SP (%)
Following widespread use of either GlaxoSmithKline's combined hepatitis A and hepatitis B vaccines or the monovalent hepatitis A and/or hepatitis B vaccines, the following adverse reactions have additionally been reported.
A i/ili hepatitisa B tvrtke GlaxoSmithKline, dodatno su prijavljene sljedeće nuspojave.
What Ambirix contains
Što Ambirix sadrži • Djelatne tvari su:
PHARMACEUTICAL PARTICULARS 6.1 List of excipients
FARMACEUTSKI PODACI 6.1 Popis pomoćnih tvari natrijev klorid voda za injekcije
• feeling drowsy
• proljev, mučnina
- Hepatitis A virus (inactivated) 1,2
- inaktivirani virus hepatitisa A1,2
The following adverse reactions were reported during clinical trials with Ambirix.
Tijekom kliničkih ispitivanja cjepiva Ambirix, prijavljene su sljedeće nuspojave:
If any of the above apply (or you are not sure), talk to your doctor, nurse or pharmacist before having Ambirix.
Ako se nešto od gore navedenoga odnosi na Vas (ili ako niste sigurni), obratite se svom liječniku,
• Hepatitis A: Infection with the hepatitis A virus may cause the liver to become swollen (inflamed).
• Hepatitis A: Infekcija virusom hepatitisa
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/.
(EMA): http://www.ema.europa.eu/
• joint pain (arthralgia)
• koprivnjača (urtikarija)
When Ambirix was administered concomitantly with, but as a separate injection to a combined diphtheria, tetanus, acellular pertussis, inactivated poliomyelitis and Haemophilus influenzae type b vaccine (DTPa-IPV+Hib) or with a combined Measles-Mumps-Rubella vaccine in the second year of life, immune responses to all antigens were satisfactory (see section 5.1).
ili s kombiniranim cjepivom protiv ospica, zaušnjaka i rubeole u drugoj godini života, primijenjenim odvojenim injekcijama, postignut je zadovoljavajući imunološki odgovor na sve antigene (vidjeti dio
The percentages with anti-HBs antibody ≥10 mIU/ml at this time point for subjects vaccinated at the 0, 6 and 0, 12
Postotak ispitanika s anti-HBs protutijelima ≥10 mIU/ml u tom trenutku za ispitanike cijepljene prema rasporedu 0, 6 mjeseci odnosno 0, 12 mjeseci bili su 84,8% odnosno 92,9%.
Ambirix
Vaskulitis
• swelling of the spinal cord (myelitis)
• oticanje kralježnične moždine (mijelitis)
This is usually into the upper arm.
Injekcija se obično daje u nadlakticu.
Nervous system disorders Very common: headache Common: drowsiness
Poremećaji metabolizma i prehrane Vrlo često: gubitak apetita
GlaxoSmithKline (Cyprus) Ltd Τηλ: + 357 22 39 70 00 gskcyprus@gsk.com
GlaxoSmithKline (Cyprus) Ltd
• fainting • loss of skin sensitivity to pain or touch (hypoaesthesia)
• utrnulost ili slabost ruku i nogu (neuropatija) • trenutna bol na mjestu primjene injekcije, osjećaj probadanja i žarenja
However the anterolateral thigh may be used in very young subjects if preferred.
Međutim, u jako mladih osoba cjepivo se može primijeniti u anterolateralni dio bedra.
10 November 2017 EMA/736863/2017 EMEA/H/C/003874
EMA/736863/2017 EMEA/H/C/003874
What is Onzeald?
Što je Onzeald?
The company that applied for authorisation is Nektar Therapeutics UK Limited.
Zahtjev za izdavanje odobrenja podnijela je tvrtka Nektar Therapeutics UK Limited.
The company informed the CHMP that patients receiving the medicine in clinical trials will continue to do so as planned.
Tvrtka je obavijestila CHMP da će bolesnici koji primaju lijek u kliničkim ispitivanjima nastaviti primati ga prema planu.
After considering the grounds for this request, the CHMP re-examined the opinion, and confirmed the refusal of the marketing authorisation on 9 November 2017.
Nakon razmatranja razloga za ovaj zahtjev CHMP je preispitao prvotno mišljenje i potvrdio odbijanje izdavanja odobrenja za stavljanje lijeka u promet dana 9. studenoga 2017.
The CHMP refusal was confirmed after re-examination.
Odbijanje CHMP-a potvrđeno je nakon preispitivanja.
Refusal of the marketing authorisation for Onzeald (etirinotecan pegol) EMA/736863/2017
Odbijanje odobrenja za stavljanje u promet lijeka Onzeald (etirinotekan pegol) EMA/736863/2017
How does Onzeald work?
Kako djeluje Onzeald?
By blocking the enzyme, cancer cells are prevented from multiplying and they eventually die.
Blokiranjem enzima sprečava se umnožavanje stanica raka i one naposljetku umiru.