natgillin/translations-raw huggingface dataset:
It can be used in adults, adolescents and children from nine months of age.
Lahko se uporablja pri odraslih, mladostnikih in otrocih od devetih mesecev starosti.
Priorix is marketed in all EU Member States as well as in Norway and Iceland.
Zdravilo Priorix je na voljo v vseh državah članicah EU ter na Norveškem in Islandiji.
Why was Priorix reviewed?
Zakaj je bilo zdravilo Priorix pregledano?
Priorix is authorised in the EU via national procedures.
Zdravilo Priorix so odobrili v EU z nacionalnimi postopki.
On 15 March 2012, the European Medicines Agency completed a review of Priorix.
Evropska agencija za zdravila je 15. marca 2012 zaključila pregled zdravila Priorix.
The CHMP also harmonised other sections of the SmPC, including sections 4.4 (warnings and precautions for use), 4.5 (interaction with other medicinal products and other forms of interaction), 4.6 (fertility, pregnancy and lactation) and 5.1 (pharmacodynamic properties).
Odbor CHMP je uskladil tudi druga poglavja povzetka glavnih značilnosti zdravila, vključno s poglavji 4.4 (Posebna opozorila in previdnostni ukrepi), 4.5 (Medsebojno delovanje z drugimi zdravili in druge oblike interakcij), 4.6 (Plodnost, nosečnost in dojenje) in 5.1 (Farmakodinamične lastnosti).
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that there is a need to harmonise the prescribing information for Priorix in the European Union (EU).
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da je potrebna uskladitev informacij o predpisovanju zdravila Priorix v Evropski uniji (EU).
The company that markets the medicine is GlaxoSmithKline (GSK) Biologicals.
Trži ga farmacevtska družba GlaxoSmithKline (GSK) Biologicals.
This has led to divergences across Member States in the way the medicine can be used, as seen in the differences in the summaries of product characteristics (SmPCs), labelling and package leaflets in the countries where the medicine is marketed.
To je povzročilo razlike med državami članicami glede načina, kako se zdravilo lahko uporablja, kar se izraža v razlikah med povzetki glavnih značilnosti zdravila, označevanji in navodili za uporabo v državah, v katerih se zdravilo trži.
Due to the divergent national positions, on 20 May 2011, GlaxoSmithKline Biologicals referred the matter to the CHMP in order to harmonise the marketing authorisations for Priorix in the EU.
Zaradi razlik med državami je družba GlaxoSmithKline Biologicals 20. maja 2011 zadevo napotila odboru CHMP, ki naj bi uskladil dovoljenja za promet z zdravilom Priorix v EU.
The CHMP recommended that this should be harmonised to nine months of age.
Odbor CHMP priporoča, da se ta meja uskladi na devet mesecev starosti.
There was some inconsistency between EU countries regarding the use of Priorix in patients infected with HIV.
Med državami EU je bilo nekaj neskladnosti pri uporabi cepiva Priorix pri bolnikih, okuženih z virusom HIV.
The CHMP recommended arranging this section according to the dosing recommendations for different age groups.
Odbor CHMP je priporočil ureditev tega poglavja po priporočilih za odmerjanje v različnih starostnih skupinah.
Priorix is also contraindicated in people with certain other conditions which severely weaken the immune system.
Cepivo Priorix je kontraindicirano tudi pri osebah z nekaterimi drugimi boleznimi, ki zelo oslabijo imunski sistem.
However, since a single dose of Priorix produces a lower immune response in children under 12 months old, the CHMP decided to include a reference to the other sections containing specific information on the use of Priorix in children between nine and 12 months old.
Ker pa enkratni odmerek cepiva Priorix povzroča manjši imunski odziv pri otrocih, mlajših od 12 mesecev, je Odbor odločil, da je treba vključiti sklic na druga poglavja, ki vsebujejo specifične informacije o uporabi cepiva Priorix pri otrocih, starih med devet in 12 mesecev.
What is Priorix?
Kaj je zdravilo Priorix?
The CHMP decided to contraindicate the use of Priorix in people with symptomatic, advanced HIV, since these patients have a severely weakened immune system which puts them at risk of serious health problems following vaccination with attenuated measles virus.
Odbor CHMP se je odločil za kontraindikacijo cepiva Priorix pri osebah s simptomatsko, napredovalo okužbo z virusom HIV, saj imajo ti bolniki zelo oslabljen imunski sistem in so zato po cepljenju z oslabljenim virusom ošpic v nevarnosti za resne zdravstvene težave.
Priorix contains small amounts of attenuated (weakened) forms of the viruses that cause measles, mumps and rubella.
Zdravilo Priorix vsebuje majhne količine atenuiranih (oslabljenih) oblik virusov, ki povzročajo ošpice, mumps in rdečke.
For children between nine and 12 months old, the CHMP decided to include a recommendation to give a second dose preferably within three months of the first dose.
V zvezi z otroki, starimi od 9 do 12 mesecev, se je odbor CHMP odločil vključiti priporočilo, da po možnosti drugi odmerek dobijo v treh mesecih po prvem.
The CHMP, in the light of the data submitted and the scientific discussion within the Committee, was of the opinion that the SmPCs, labelling and package leaflets should be harmonised across the EU.
Odbor CHMP je ob upoštevanju predloženih podatkov in znanstvene razprave v Odboru menil, da je treba povzetke glavnih značilnosti zdravila, označevanje in navodila za uporabo uskladiti v vsej EU.
When a person is given Priorix, the immune system recognises the viruses as ‘foreign' and makes antibodies against them.
Ko oseba prejme cepivo Priorix, imunski sistem prepozna bakterijo v cepivu kot „tujek“ in proti njej razvije protitelesa.
There was some inconsistency between EU countries regarding the approved lower age limit for Priorix, which varied from nine months to 15 months of age.
Med državami EU je bilo nekaj neskladnosti pri odobreni spodnji starostni meji za uporabo cepiva Priorix, ki je bila v razponu od devet do 15 mesecev starosti.
In the future, the immune system will be able to produce antibodies more quickly when it is exposed to these viruses.
Imunski sistem bo tako ob ponovni izpostavitvi virusom hitreje tvoril protitelesa.
Priorix is a vaccine used to protect against measles, mumps and rubella (German measles).
Zdravilo Priorix je cepivo, ki se uporablja za zaščito proti ošpicam, mumpsu in rdečkam (rubella).
The review of Zydelig was initiated at the request of the European Commission on 17 March 2016, under Article 20 of Regulation (EC) No 726/2004.
Pregled zdravila Zydelig se je pričel 17. marca 2016 na zahtevo Evropske komisije v skladu s členom 20 Uredbe (ES) št. 726/2004.
In its review the PRAC evaluated data from these studies, together with other available evidence as well as advice from experts in this field.
Pri svojem pregledu je odbor PRAC ovrednotil podatke iz teh študij skupaj z drugimi razpoložljivimi dokazi in nasveti strokovnjakov s tega področja.
A letter will be sent to healthcare professionals, advising them of these changes.
Zdravstveni delavci bodo pisno obveščeni o teh spremembah.
If you are taking Zydelig and have any questions or concerns speak to your doctor, nurse or pharmacist.
Če jemljete zdravilo Zydelig in imate kakršna koli vprašanja ali pomisleke, se posvetujte z zdravnikom, medicinsko sestro ali farmacevtom.
1 17p deletion or TP53 mutation, see http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2016/03/news_detail_002490.jsp
1 Delecija 17p ali mutacija TP53, glejte http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2016/03/news_detail_002490.jsp.
The relevance of these results to the authorised use of Zydelig is therefore limited, but suggests a need to strengthen measures to minimise the risk of infection.
Pomen teh rezultatov za odobreno uporabo zdravila Zydelig je zato omejen, vendar pa kaže potrebo po okrepitvi dejavnosti za zmanjševanje tveganja za okužbo.
However, following a review it has updated recommendations to minimise the risk of serious infections in patients treated with the medicine.
Vendar je po pregledu posodobil priporočila za zmanjšanje tveganja za resne okužbe pri bolnikih, zdravljenih s tem zdravilom.
Patients receiving Zydelig should also be monitored for signs of infection and have regular blood tests to measure the level of white blood cells.
Bolnike, ki prejemajo zdravilo Zydelig, je treba spremljati tudi zaradi znakov okužbe in pri njih redno opravljati krvne preiskave za merjenje števila belih krvnih celic.
If you develop fever, cough or difficulty breathing you should contact your doctor straight away.
Če se pojavi povišana telesna temperatura, kašelj ali težave z dihanjem, se takoj posvetujte z zdravnikom.
Although the studies did not use the medicine in the same way as currently authorised, the review concluded that the risk of serious infection had some relevance to the authorised use.
Čeprav se v študijah zdravilo ni uporabljalo na način, za katerega je trenutno odobreno, je pregled pokazal, da je tveganje za resno okužbo pomembno za odobreno uporabo.
• You will have regular blood tests to check if you have a low white blood cell count, as a low count can put you at more risk of developing an infection.
• Imeli boste redne krvne preiskave, da bodo preverili, ali imate nizko število belih krvnih celic, saj imate lahko zaradi tega večje tveganje za okužbo.
The percentage of deaths in the treatment arms was 8% in the CLL study and 8% and 5% in the lymphoma studies, compared with 3%, 6% and 1% respectively in the placebo arms.
Odstotek smrti v skupinah bolnikov, ki so prejemali zdravilo, je bil 8 % v študiji KLL ter 8 in 5 % v študijah limfoma, v primerjavi s 3, 6 oziroma 1 % v skupinah bolnikov, ki so prejemali placebo.
The CHMP has confirmed the recommendations from the PRAC review, and its opinion will now be sent to the European Commission for a final legally binding decision.
Odbor CHMP je potrdil priporočila na podlagi pregleda odbora PRAC in njegovo mnenje je bilo poslano Evropski komisiji, ki je izdala končno pravno zavezujočo odločbo.
Because some infections have occurred after patients had finished their cancer treatment, you will have to keep taking these antibiotics for 2 to 6 months after stopping Zydelig.
Ker so se nekatere okužbe pojavile, ko so bolniki prenehali z zdravljenjem proti raku, boste morali te antibiotike jemati še 2 do 6 mesecev po prenehanju jemanja zdravila Zydelig.
Low white cell counts can indicate an increased risk of infection and treatment may need to be interrupted.
Nizko število belih krvnih celic lahko kaže na večje tveganje za okužbo, zaradi česar bo zdravljenje morda treba prekiniti.
• If you are taking Zydelig, you will receive antibiotics to prevent a type of lung infection (Pneumocystis jirovecii pneumonia).
• Če jemljete zdravilo Zydelig, boste prejeli antibiotike za preprečevanje določene vrste pljučne okužbe (pljučnice, ki jo povzroča Pneumocystis jirovecii).
• You should not stop Zydelig without speaking to your doctor.
• Zdravila Zydelig ne prenehajte jemati, dokler se ne posvetujete z zdravnikom.
Patients should be monitored for respiratory signs and symptoms.
Bolnike je treba spremljati glede pojava znakov in simptomov na dihalih.
The review, which was carried out by EMA's Pharmacovigilance Risk Assessment Committee (PRAC), was started because of deaths seen in 3 studies in which Zydelig was given to patient groups for whom it is not licensed, or in unlicensed combinations with other medicines.
Pregled, ki ga je opravil Odbor za oceno tveganja na področju farmakovigilance (PRAC) agencije EMA, je bil sprožen zaradi smrti bolnikov, ki so jih zabeležili v treh študijah, kjer so zdravilo Zydelig dajali skupinam bolnikov, za katere to ni odobreno, ali v neodobrenih kombinacijah z drugimi zdravili.
• These studies included patients with disease characteristics that were different from those covered by the currently approved indications for Zydelig and investigated use with treatment combinations that are not currently licensed and which may have influenced the infection rate.
• Te študije so vključevale bolnike z značilnostmi bolezni, ki so bile drugačne od značilnosti, zajetih v trenutno odobrenih indikacijah za zdravilo Zydelig, v njih pa so preučevali uporabo s kombinacijami zdravil, ki trenutno niso odobrene in ki so morda vplivale na delež okužb.
The additional deaths were mainly caused by infections, including Pneumocystis jirovecii pneumonia and cytomegalovirus infections.
Dodatne smrti so v glavnem povzročile okužbe, vključno s pljučnico, ki jo povzroča Pneumocystis jirovecii, in okužbami s citomegalovirusom.
• Patients should be informed about the risk of serious infections with Zydelig.
• Bolnike je treba obvestiti, da pri zdravljenju z zdravilom Zydelig obstaja tveganje za resne okužbe.
Some changes have now been made in how the medicine is used to ensure it is given as safely as possible.
Za zagotovitev čim varnejšega dajanja je bilo uvedenih nekaj sprememb pri načinu uporabe zdravila.
• Your doctor will regularly check you for signs of infections.
• Zdravnik bo redno preverjal, ali so prisotni znaki okužbe.
CHMP confirms recommendations for use of Zydelig
Odbor CHMP potrjuje priporočila za uporabo zdravila
Zydelig is a cancer medicine containing the active substance idelalisib.
Zydelig je zdravilo za zdravljenje raka, ki vsebuje zdravilno učinkovino idelalizib.
Zydelig should also not be started in patients with any generalised infection.
Zdravilo Zydelig se prav tako ne sme uvesti pri bolnikih s kakršno koli generalizirano okužbo.
The CHMP opinion will now be forwarded to the European Commission, which will issue a final legally binding decision applicable in all EU Member States in due course.
Mnenje odbora CHMP je bilo predloženo Evropski komisiji, ki je dne 15.09.2016 izdala končno pravno zavezujočo odločbo, ki velja za vse države članice EU.
In the EU, Zydelig is authorised for the treatment of two cancers of white blood cells, chronic lymphocytic leukaemia and follicular lymphoma (one of a group of cancers called non-Hodgkin's lymphomas).
V EU je zdravilo Zydelig odobreno za zdravljenje dveh vrst raka belih krvnih celic, tj. kronične limfocitne levkemije in folikularnega limfoma (enega iz skupine rakov, imenovanih ne-Hodgkinovi limfomi).
• All patients should receive prophylaxis for P. jirovecii pneumonia during Zydelig treatment and for 2 to 6 months after stopping treatment.
• Vsi bolniki morajo med zdravljenjem z zdravilom Zydelig in še 2 do 6 mesecev po prenehanju zdravljenja prejemati profilaktično zdravljenje za pljučnico, ki jo povzroča P. jirovecii.
In addition, following an interim precautionary recommendation not to start Zydelig treatment in previously untreated patients with CLL that has certain genetic mutations1, the CHMP now concludes that treatment with Zydelig can again be started in these patients provided they alternative treatments are not suitable and provided that the measures to prevent infection are followed.
Poleg tega po vmesnem varnostnem priporočilu, da se zdravljenje z zdravilom Zydelig ne sme uvesti pri predhodno nezdravljenih bolnikih s KLL, ki imajo določene genske mutacije1, je odbor CHMP zaključil, da se lahko zdravljenje z zdravilom Zydelig ponovno uvede pri teh bolnikih, če druge vrste zdravljenj zanje niso primerne in ob upoštevanju ukrepov za preprečevanje okužbe.
The PRAC recommendations were sent to the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which adopted the Agency's opinion.
Priporočila odbora PRAC so bila poslana Odboru za zdravila za uporabo v humani medicini (CHMP), odgovornemu za vprašanja glede zdravil za uporabo v humani medicini, ki je mnenje agencije sprejel 21. julija 2016.
• In follicular lymphoma, Zydelig is used on its own in patients whose disease has not responded to two previous treatments.
• Pri folikularnem limfomu se zdravilo Zydelig uporablja kot samostojno zdravilo pri bolnikih, katerih bolezen se ni odzvala na dve predhodni zdravljenji.
Patients should be monitored for infection and given antibiotics during and after treatment
Bolnike je treba spremljati glede okužb in jim dajati antibiotike med zdravljenjem in po njem21.
• There have been reports of serious infections in clinical studies with the cancer medicine Zydelig.
• Iz kliničnih študij z zdravilom Zydelig za zdravljenje raka so poročali o resnih okužbah.
• In chronic lymphocytic leukaemia, Zydelig is used in combination with another medicine (rituximab) in patients who have received at least one previous treatment and in previously untreated patients who have genetic mutations in their cancer cells called 17p deletion or TP53 mutation and who are not eligible for other therapies.
• Pri kronični limfocitni levkemiji se zdravilo Zydelig uporablja v kombinaciji z drugim zdravilom (rituksimabom) pri bolnikih, ki so prejemali vsaj eno predhodno zdravljenje, in pri predhodno nezdravljenih bolnikih, ki imajo v rakavih celicah genske mutacije, imenovane delecija 17p ali mutacija TP53, in za katere druga zdravljenja niso primerna.
If the patient develops severe neutropenia, treatment with Zydelig may have to be interrupted, in line with the updated SmPC.
Če se pri bolniku pojavi huda nevtropenija, bo zdravljenje z zdravilom Zydelig skladno s posodobljenim povzetkom glavnih značilnosti zdravila morda treba prekiniti.
• Provided that strengthened measures are followed to minimise the risk of infection (see below), Zydelig can continue to be used in combination with rituximab in CLL patients who have received at least one prior therapy, and as monotherapy in patients with follicular lymphoma that is refractory to two lines of treatment.
• Ob upoštevanju okrepljenih dejavnosti za zmanjševanje tveganja za okužbo (glejte spodaj) se lahko zdravilo Zydelig še naprej uporablja v kombinaciji z rituksimabom pri bolnikih s KLL, ki so prejemali vsaj eno predhodno zdravljenje, in kot monoterapija pri bolnikih s folikularnim limfomom, neodzivnim na dve obliki zdravljenja.
The CHMP (EMA's Committee for Medicinal Products for Human Use) has confirmed that the benefits of Zydelig (idelalisib) in the treatment of the blood cancers chronic lymphocytic leukaemia (CLL) and follicular lymphoma outweigh the risk of side effects.
julija 2016 je odbor CHMP (Odbor za zdravila za uporabo v humani medicini agencije EMA) potrdil, da koristi zdravila Zydelig (idelalizib) pri zdravljenju krvnih rakov, tj. kronične limfocitne levkemije (KLL) in folikularnega limfoma, odtehtajo tveganja za neželene učinke.
• Zydelig may also be used in combination with rituximab, as first line treatment in CLL in the presence of 17p deletion or TP53 mutation provided patients cannot take any alternative treatment and provided again that the below measures are followed to reduce the risk of infection.
• Zdravilo Zydelig se lahko prav tako uporablja v kombinaciji z rituksimabom kot zdravilo prve izbire pri bolnikih s KLL, pri katerih je prisotna delecija 17p ali mutacija TP53, če bolniki ne morejo prejemati nobenega alternativnega zdravljenja in ob upoštevanju spodnjih dejavnosti za zmanjševanje tveganja za okužbo.
Regular clinical and laboratory monitoring for cytomegalovirus infection is also recommended and specific guidance is included in the updated summary of product characteristics (SmPC).
V posodobljeni povzetek glavnih značilnosti zdravila so vključena tudi priporočila glede rednega kliničnega in laboratorijskega spremljanja okužb s citomegalovirusom ter posebna navodila.
GS-US-313-0124 a phase 3, randomised, double blind, placebo-controlled study evaluating the efficacy and safety of idelalisib in combination with rituximab for previously treated iNHL;
GS-US-313-0124, randomizirana, dvojno slepa, s placebom nadzorovana študija III. faze o učinkovitosti in varnosti idelaliziba v kombinaciji z rituksimabom za predhodno zdravljeni iNHL;
GS-US-313-0125 a phase 3, randomised, double blind, placebo-controlled study evaluating the efficacy and safety of idelalisib in combination with bendamustine and rituximab for previously treated iNHL;
GS-US-313-0125, randomizirana, dvojno slepa, s placebom nadzorovana študija III. faze o učinkovitosti in varnosti idelaliziba v kombinaciji z bendamustinom in rituksimabom za predhodno zdravljeni iNHL.
2 GS-US-312-0123 a phase 3, randomised, double blind, placebo-controlled study evaluating the efficacy and safety of idelalisib in combination with bendamustine and rituximab for previously untreated CLL;
GS-US-312-0123, randomizirana, dvojno slepa, s placebom nadzorovana študija III. faze o učinkovitosti in varnosti idelaliziba v kombinaciji z bendamustinom in rituksimabom za predhodno nezdravljeno KLL;
Your doctor may stop your treatment with Zydelig if your white blood cell count is too low.
Če imate prenizko število belih krvnih celic, bo zdravnik vaše zdravljenje z zdravilom Zydelig morda prekinil.
All patients treated with Zydelig should be given preventive medication against the lung infection Pneumocystis jirovecii pneumonia during treatment and this should be continued for up to 6 months after treatment with Zydelig has stopped.
Vsi bolniki, zdravljeni z zdravilom Zydelig, morajo med zdravljenjem prejemati preventivno zdravilo proti okužbi pljuč s pljučnico, ki jo povzroča Pneumocystis jirovecii.
• Increased rates of serious adverse effects including deaths were seen in the treatment arm of 3 clinical trials2 evaluating the addition of Zydelig to standard therapy in first-line treatment of CLL and relapsed indolent non-Hodgkin lymphoma.
• V treh kliničnih preskušanjih2, v katerih so vrednotili dodajanje zdravila Zydelig k standardnemu zdravljenju pri prvi izbiri zdravljenja KLL in ponovljenem indolentnem ne-Hodgkinovem limfomu, so v skupini bolnikov, ki je prejemala zdravilo, opazili povečano pogostnost resnih neželenih učinkov, vključno s smrtnimi primeri.
Emphasise that patients should persist with the treatment.
poudarjajo, da mora bolnik z zdravljenjem nadaljevati,
That cough decreases with repeated use of the product and should stabilize after the first month or so.
se kašelj zmanjšuje s ponavljajočo uporabo zdravila in se bo približno po prvem mesecu stabiliziral.
These are only of nuisance value for most patients
predstavljajo za večino bolnikov le neprijetnost,
ANNEX CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
PRILOGA POGOJI IN OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA
The Member States shall ensure that all physicians who are expected to prescribe or use Colobreathe are provided with a healthcare professional and patient educational pack containing the following:
Države članice morajo poskrbeti, da bodo vsi zdravniki, ki bodo predpisovali zdravilo Colobreathe, prejeli paket izobraževalnega gradiva za zdravstvene delavce in navodila za bolnike, ki vsebuje:
• “Physician DVD” information in “leaflet form” for those physicians who do not have access to a
• podatke »DVD za zdravnika« v »obliki brošure z navodili« za zdravnike, ki nimajo dostopa do predvajalnika DVD
The Member States should ensure that all conditions or restrictions with regard to the safe and effective use of the medicinal product described below are implemented: The Member States shall agree the final healthcare professional and patient educational pack with the Marketing Authorization Holder (MAH) prior to launch of the product in their territory.
Države članice se bodo pred dajanjem zdravila na svoje tržišče z imetnikom dovoljenja za promet z zdravilom dogovorile o končnem izobraževalnem gradivu.
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Razlaga o pripomočku
It works by blocking the activity of reverse transcriptase, an enzyme needed by HIV to produce the genetic instructions for making more viruses once it has infected the cell.
Deluje tako, da zavira delovanje reverzne transkriptaze, tj. encima, ki ga virus HIV potrebuje za izdelavo genskih navodil za tvorbo še več virusov, potem ko je okužil celico.