natgillin/translations-raw huggingface dataset:
• In children with HIV infection, vaccination is contraindicated in those with age-specific CD4+ percentages of less than 25% below 12 months, less than 20% between 12 and 35 months, or less 15% between 36 and 59 months.
• Pri otrocih z okužbo z virusom HIV je cepljenje kontraindicirano za tiste otroke, ki imajo določen delež CD4+ za njihovo starost manjši od 25 % pri mlajših od 12 mesecev, manjši od 20 % pri starosti od 12 do 35 mesecev ali manjši od 15 % pri starosti od 36 do 59 mesecev.
The Committee also recommended that some changes be made to the product information to clarify the risks and precautions to be taken.
Odbor je prav tako priporočil, da se uvedejo nekatere spremembe v informacije o zdravilu, s katerimi se bodo pojasnila tveganja in previdnostni ukrepi, ki jih je treba uvesti.
They contain live attenuated (weakened) versions of the viruses responsible for these diseases.
Vsebujejo žive, atenuirane (oslabljene) različice virusov, ki povzročajo te bolezni.
• Patients with severe weakness of their immune system must not receive these vaccines.
• Bolniki s hudo oslabljenim imunskim sistemom ne smejo prejemati teh cepiv.
For patients with immune deficiencies, the Committee looked at evidence from clinical studies and reports from post-marketing use.
Pri bolnikih z imunskimi pomanjkljivostmi je odbor preučil dokaze iz kliničnih študij in poročila glede uporabe v obdobju trženja.
If a woman is, or thinks she may be, pregnant she should tell her doctor or nurse before receiving any of these vaccines.
Če je ženska noseča ali meni, da bi lahko bila noseča, naj o tem obvesti svojega zdravnika ali medicinsko sestro, preden prejme ta cepiva.
Other monovalent and multivalent vaccines against measles, mumps, rubella, and varicella have been available for many years and are authorised by national procedures in the EU Member States, under different trade names including Amunovax, Priorix, Priorix Tetra, Provarivax, R.O.R.
Druga mono- in polivalentna cepiva proti ošpicam, mumpsu, rdečkam ter noricam so na voljo že mnogo let in so odobrena z nacionalnimi postopki v državah članicah EU pod različnimi tržnimi imeni, vključno z Amunovax, Priorix, Priorix Tetra, Provarivax, R.O.R.
The evidence did suggest that there was no need to delay pregnancy for more than one month after vaccination.
Dokazi so pokazali, da ni potrebe po tem, da bi zanositev odlagali za več kot en mesec po cepljenju.
MMRV contain weakened but live viruses.
Cepiva MMRV vsebujejo oslabljene, vendar žive viruse.
MMRV may be available as individual vaccines for each infection (monovalent) or as combination vaccines (multivalent).
MMRV je lahko na voljo v obliki posameznih cepiv za vsako okužbo (monovalentnih) ali kombiniranih cepiv (polivalentnih).
Although these are too weak to cause health problems in healthy adults, their use in pregnant women has not been authorised due to a potential risk to the unborn baby, and women have been advised not to become pregnant for three months after vaccination.
Čeprav so ti virusi prešibki, da bi povzročili zdravstvene težave pri zdravih odraslih osebah, njihova uporaba pri nosečnicah ni odobrena zaradi morebitnega tveganja za nerojenega otroka, ženskam pa se svetuje, da še tri mesece po cepljenju ne zanosijo.
At the same time, the European Commission asked the CHMP to extend their considerations to cover the centrally authorised products, and examine if their marketing authorisations should be varied or maintained.
Sočasno je Evropska komisija CHMP zaprosila, naj ponovno pregled razširi tako, da bo vključevala zdravila, odobrena po centraliziranem postopku, in preuči, ali naj se njihova dovoljenja za promet spremenijo ali ohranijo.
This included reports on over 3,500 women inadvertently given a rubellacontaining vaccine in early pregnancy, and over 1,800 who were given a varicella-containing vaccine during pregnancy.
To je vključevalo poročila o več kot 3500 ženskah, ki so jim v zgodnji nosečnosti nenamerno dali cepivo, ki vsebuje virus rdečk, in o več kot 1800 ženskah, ki so jim med nosečnostjo dali cepivo, ki vsebuje virus noric.
However, since these vaccines were authorised, new data from post-marketing use and from the published literature have become available on their safety in pregnancy and in patients with immune deficiencies.
Odkar pa so bila ta cepiva odobrena, so bili zbrani novi podatki iz uporabe v obdobju trženja cepiv in iz objavljene literature o njihovi varnosti med nosečnostjo ter pri bolnikih z imunskimi pomanjkljivostmi.
In patients with less severe immune weakness, vaccination may be considered, although it does not always give the same protection as in a person with a healthy immune system.
Pri bolnikih z blažjo imunsko pomanjkljivostjo se cepljenje lahko uporabi, čeprav ne zagotovi vedno enake zaščite kot pri osebah z zdravim imunskim sistemom.
MMRV are also contraindicated in patients with immune deficiencies, in whom the vaccine may not work properly and who might be at risk of developing severe or widespread disease.
Cepiva MMRV so prav tako kontraindicirana pri bolnikih z imunskimi pomanjkljivostmi, pri katerih cepivo morda ne bo delovalo pravilno in ki so lahko izpostavljeni tveganju za razvoj hude ali razširjene bolezni.
Based on the evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the benefits of MMRV do not outweigh their risks in pregnancy or in severe immune deficiencies, and recommended that vaccination should continue to be contraindicated in these groups.
Na podlagi ocene trenutno razpoložljivih podatkov ter znanstvene razprave znotraj odbora je ta sklenil, da koristi cepiv MMRV niso večje od z njimi povezanih tveganj med nosečnostjo ali pri hudih imunskih pomanjkljivostih, in priporočil, da naj bo cepljenje pri teh skupinah še naprej kontraindicirano.
On 13 December 2012, the European Medicines Agency completed a review of the use of monovalent and multivalent measles, mumps, rubella and/or varicella vaccines (MMRV) during pregnancy and in patients with immune deficiencies (weakened immune systems).
Evropska agencija za zdravila je 13. decembra 2012 končala ponovni pregled uporabe mono- in polivalentnih cepiv proti ošpicam, mumpsu, rdečkam in/ali noricam (MMRV) med nosečnostjo in pri bolnikih z imunskimi pomanjkljivostmi (oslabljenim imunskim sistemom).
• If a woman becomes pregnant within one month after receiving one of these vaccines, it does not mean that her baby is definitely at risk, or that the pregnancy needs to be terminated.
• Če ženska zanosi v enem mesecu po cepljenju s temi cepivi, to ne pomeni, da je otrok zagotovo izpostavljen tveganju ali da je treba nosečnost prekiniti.
Some viruses are able to cross the placenta in pregnant women and infect their unborn babies.
Nekateri virusi lahko prehajajo skozi posteljico pri nosečnicah in okužijo nerojene otroke.
The full changes made to the information to doctors and patients are detailed here for M-M-RVAXPRO, here for ProQuad, here for Zostavax and here for the nationally authorised products.
Podroben opis celotnih sprememb informacij za zdravnike ter bolnike za zdravilo M-M-RVAXPRO je na voljo tukaj, za zdravilo ProQuad tukaj, za zdravilo Zostavax tukaj in za nacionalno odobrena zdravila tukaj.
As a result, the Belgian medicines agency asked the CHMP to carry out an assessment of the benefit-risk balance of vaccination in these groups and to issue an opinion on whether the marketing authorisations for MMRV should be varied or maintained.
Posledično je belgijska agencija za zdravila odbor CHMP zaprosila, da oceni razmerje med tveganji in koristmi cepljenja pri teh skupinah in izda mnenje, ali naj se dovoljenja za promet s cepivi MMRV spremenijo ali ohranijo.
The multivalent vaccines M-M-RVAXPRO and ProQuad, and the monovalent zoster (shingles) vaccine Zostavax, are centrally authorised for use throughout the European Union (EU).
Polivalentni cepivi M-M-RVAXPRO in ProQuad ter monovalentno cepivo proti herpesu zoster (pasavcu) Zostavax so cepiva, odobrena po centraliziranem postopku za uporabo v celotni Evropski uniji (EU).
Patients with severe immune deficiencies were at risk of serious adverse effects if given live virus vaccines, but in patients with minor immune deficiencies, including those with HIV infection but adequate blood counts of CD4 cells (a type of white blood cell important in fighting infection), the evidence suggested that MMRV could be given safely and might provide benefit.
Bolniki s hudimi imunskimi pomanjkljivostmi so bili izpostavljeni tveganju za resne neželene učinke, če so prejeli cepiva z živimi virusi, medtem ko pri bolnikih z blažjimi imunskimi pomanjkljivostmi, vključno z bolniki z okužbo z virusom HIV, ki imajo zadostno število celic CD4 v krvi (vrsta belih krvničk, pomembnih pri borbi z okužbo), dokazi kažejo, da se lahko cepiva MMRV uporabljajo varno in so lahko koristna.
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that these vaccines should continue to be avoided during pregnancy, but that inadvertent vaccination of pregnant women with measles-, mumps- and/or rubella-containing vaccines should not be a reason for termination of pregnancy.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je sklenil, da se je treba tem cepivom še vedno izogibati med nosečnostjo, vendar nenamerno cepljenje nosečnic s cepivi proti ošpicam, mumpsu in/ali rdečkam ni razlog za prekinitev nosečnosti.
• Women who are given one of these vaccines should take the necessary precautions to avoid becoming pregnant for one month after vaccination.
• Ženske, ki prejmejo ta cepiva, morajo upoštevati potrebne previdnostne ukrepe, da preprečijo zanositev en mesec po cepljenju.
The rate of malformations or spontaneous abortions in women who were exposed to MMRV during pregnancy was no higher than the expected rate in unvaccinated women.
Delež primerov deformacij ali spontanih splavov pri ženskah, izpostavljenih cepivu MMRV med nosečnostjo, ni bil večji od pričakovanega deleža pri necepljenih ženskah.
• Vaccination with MMRV remains contraindicated in pregnancy and in patients with severe humoral or cellular immunodeficiency (such as severe combined immunodeficiency, agammaglobulinaemia, or AIDS).
• Cepljenje s cepivi MMRV še vedno ostaja kontraindicirano pri nosečnicah in bolnikih z hudo humoralno ali celično imunodeficienco (kot so huda kombinirana imunodeficienca, agamaglobulinemija ali aids).
The CHMP reviewed the available safety data on MMRV in pregnancy from post-marketing use and the published literature, focusing on the risk of spontaneous abortion, stillbirth, malformations, immaturity and low birth weight.
CHMP je pregledal razpoložljive podatke o varnosti cepiv MMRV v nosečnosti iz uporabe v obdobju trženja in iz objavljene literature, pri čemer se je osredotočil na tveganje spontanega splava ter mrtvorojenosti, deformacij, nezrelosti in majhne porodne telesne mase novorojenčka.
Why were MMRV reviewed?
Zakaj so bila cepiva MMRV ponovno preučena?
Vaccination may be considered in patients with minor immune deficiencies if the benefit outweighs the risk.
Zdravnik lahko o cepljenju razmisli pri bolnikih z blažjimi imunskimi pomanjkljivostmi, če je korist večja od tveganja.
• Vaccination may be considered in patients with certain immune deficiencies where the benefits outweigh the risks of vaccination (e.g. asymptomatic HIV-infected patients, patients with selective IgG subclass deficiencies, congenital neutropenia, chronic granulomatous disease and complement deficiency diseases).
• O cepljenju je treba razmisliti pri bolnikih z nekaterimi imunskimi pomanjkljivostmi, če so koristi večje od tveganj cepljenja (npr. bolniki z asimptomatično okužbo z virusom HIV, bolniki s selektivnimi pomanjkljivostmi podrazreda IgG, kongenitalno nevtropenijo, kronično granulomatozno boleznijo in komplementarnimi boleznimi z imunsko pomanjkljivostjo).
• Women should not be given monovalent or multivalent MMRV during pregnancy.
• Ženske med nosečnostjo ne smejo prejeti mono- ali polivalentnih cepiv MMRV.
Inadvertent vaccination with rubella-containing vaccines during pregnancy is not a reason for termination.
Nenamerno cepljenje med nosečnostjo s cepivi, ki vsebujejo virus rdečk, ni razlog za prekinitev nosečnosti.
• Immunocompromised patients who are vaccinated may not develop adequate immunity and should be monitored for subsequent development of measles, parotitis, rubella or varicella after contact with these diseases.
• Pri cepljenih bolnikih z oslabljenim imunskim sistemom se morda ne bo razvila zadostna imunost, te bolnike pa je treba spremljati glede poznejšega pojava ošpic, parotitisa, rdečk ali noric ob stiku s temi boleznimi.
In addition MMRV should continue to be avoided in patients with the most severely weakened immune systems, but their use could be considered in less severe immune deficiency.
Poleg tega se morajo cepivom MMRV še vedno izogibati bolniki z najhuje oslabljenim imunskim sistemom, o njihovi uporabi pa zdravnik lahko razmisli pri imunski pomanjkljivosti manjše resnosti.
• Women should be advised to delay becoming pregnant for one month after MMRV vaccination.
• Ženskam je treba svetovati, naj z zanositvijo počakajo en mesec po cepljenju s cepivi MMRV.
Although a risk cannot be completely excluded, no cases of congenital rubella syndrome or congenital varicella syndrome have been reported among over 5,300 reports in women who were inadvertently given MMRV during pregnancy.
Čeprav tveganja ni mogoče popolnoma izključiti, pri več kot 5 300 poročilih o ženskah, ki so med nosečnostjo nenamerno prejele cepivo MMRV, ni bilo poročil o nobenem primeru kongenitalnega sindroma rdečk ali kongenitalnega sindroma noric.
MMRV are vaccines that help protect against the viral infections measles, mumps, rubella, and varicella (which may cause chickenpox or shingles [zoster]).
MMRV so cepiva, ki pomagajo zaščititi pred okužbami z virusi ošpic, mumpsa, rdečk in noric (ki lahko povzroči norice ali pasavca (herpes zoster)).
However, women intending to become pregnant need only delay for one month after vaccination, and inadvertent rubella vaccination of women who are pregnant need not be a reason for termination of the pregnancy.
Vendar lahko ženske, ki načrtujejo nosečnost, z zanositvijo počakajo samo en mesec po cepljenju, nenamerno cepljenje nosečnic proti rdečkam pa ne sme biti razlog za prekinitev nosečnosti.
The European Commission issued a decision for M-M-RVAXPRO Article 20 on 20 February 2013.
Evropska komisija je 20. februarja 2013 izdala sklep o cepivu M-M-RVAXPRO na podlagi člena 20.
The European Commission issued a decision for ProQuad Article 20 on 18 February 2013
Evropska komisija je 18. februarja 2013 izdala sklep o cepivu ProQuad na podlagi člena 20.
The current European public assessment report for ProQuad can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports
Trenutno evropsko javno poročilo o oceni zdravila (EPAR) za cepivo ProQuad je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports
The current European public assessment report for M-M-RVAXPRO can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports
Trenutno evropsko javno poročilo o oceni zdravila (EPAR) za cepivo M-M-RVAXPRO je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports
The current European public assessment report for Zostavax can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports
Trenutno evropsko javno poročilo o oceni zdravila (EPAR) za cepivo Zostavax je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports
In particular, rubella can cause malformations and problems particularly with the ears, eyes and heart (known as ‘congenital rubella syndrome') and varicella can cause malformations affecting the limbs (known as ‘congenital varicella syndrome') in babies whose mothers become infected in early pregnancy.
Pri otrocih, katerih matere so se okužile v zgodnji nosečnosti, lahko predvsem virus rdečk povzroči deformacije in težave, zlasti z ušesi, očmi in srcem (imenovane „kongenitalni sindrom rdečk“), virus noric pa deformacije, ki prizadenejo okončine (imenovan „kongenitalni sindrom noric“).
The European Commission issued a decision for Zostavax Article 20 on 13 February 2013.
Evropska komisija je 13. februarja 2013 izdala sklep o cepivu Zostavax na podlagi člena 20.
The European Commission issued a correcting decision for MMRV Art 31 on 27 June 2013.
Evropska komisija je 27. junija 2013 izdala popravek sklepa o cepivih MMRV na podlagi člena 31.
The European Commission issued a decision for MMRV Article 31 on 28 February 2013.
Evropska komisija je 28. februarja 2013 izdala sklep o cepivih MMRV na podlagi člena 31.
What are MMRV?
Kaj so cepiva MMRV?
This overview was last updated in 07-2018.
Povzetek je bil nazadnje posodobljen 07-2018.
Further information on Exjade can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Nadaljnje informacije za zdravilo Exjade so na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
About half of the patients were under the age of 16 years, and 56 were less than 6 years old.
Približno polovica jih je bilo mlajših od 16 let, 56 pa mlajših od šest let.
The company will also prepare a similar pack for patients.
Družba bo podobno gradivo pripravila tudi za bolnike.
Exjade is taken once a day at around the same time.
Zdravilo Exjade se jemlje enkrat na dan ob približno istem času.
What measures are being taken to ensure the safe and effective use of Exjade?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Exjade?
Other information about Exjade
Druge informacije o zdravilu Exjade
The European Medicines Agency decided that Exjade's benefits are greater than its risks and it can be authorised for use in the EU.
Evropska agencija za zdravila je zaključila, da so koristi zdravila Exjade večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
Exjade received a marketing authorisation valid throughout the EU on 28 August 2006.
Za zdravilo Exjade je bilo 28. avgusta 2006 izdano dovoljenje za promet, veljavno po vsej EU.
Exjade was not as effective overall as the comparator medicine.
Zdravilo Exjade v splošnem ni bilo tako učinkovito kot primerjalno zdravilo.
What is Exjade and what is it used for?
Kaj je zdravilo Exjade in za kaj se uporablja?
It must not be used in combination with other iron chelators.
Zdravilo se ne sme uporabljati v kombinaciji z drugimi kelatorji železa.
The company that markets Exjade must issue an education pack to healthcare professionals.
Družba, ki izdeluje zdravilo Exjade, mora izdati izobraževalno gradivo za zdravstvene delavce.
The main measure of effectiveness was the change in iron levels in the liver after 12 months of treatment.
Glavno merilo učinkovitosti je bila sprememba ravni železa v jetrih po 12 mesecih zdravljenja.
As for all medicines, data on the use of Exjade are continuously monitored.
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Exjade stalno spremljajo.
However, in the 381 patients who had particularly high levels of iron at the beginning of the study and who received comparable amounts of Exjade and deferoxamine, the two medicines were as effective as each other.
Vendar sta bili pri 381 bolnikih, ki so imeli posebno visoke ravni železa na začetku študije in so prejemali primerljive količine zdravila Exjade in deferoksamina, obe zdravili enako učinkoviti.
Side effects reported with Exjade are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri zdravilu Exjade, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
What are the risks associated with Exjade?
Kakšna tveganja so povezana z zdravilom Exjade?
The body cannot remove iron effectively and excess iron can cause damage.
Telo ne more učinkovito odstranjevati železa, presežek železa pa lahko povzroči okvaro.
In patients treated with Exjade, liver iron levels decreased on average by 3.8 mg per gram of liver compared with an average increase of 0.4 mg per gram of liver in patients treated with placebo.
Pri bolnikih, ki so bili zdravljeni z zdravilom Exjade, se je raven železa v jetrih povprečno zmanjšala za 3,8 mg na gram jeter, v primerjavi s povprečnim povečanjem za 0,4 mg na gram jeter pri bolnikih, zdravljenih s placebom.
Why is Exjade authorised in the EU?
Zakaj je bilo zdravilo Exjade odobreno v EU?
The iron level was reduced satisfactorily in 53% of the patients receiving Exjade, compared with 66% of the patients receiving deferoxamine.
Raven železa se je zadovoljivo zmanjšala pri 53 % bolnikov, ki so prejemali zdravilo Exjade, v primerjavi s 66 % bolnikov, ki so prejemali deferoksamin.
What benefits of Exjade have been shown in studies?
Kakšne koristi je zdravilo Exjade izkazalo v študijah?
An overview of Exjade and why it is authorised in the EU
Pregled zdravila Exjade in zakaj je odobreno v EU
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Exjade have also been included in the summary of product characteristics and the package leaflet.
Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Exjade upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
The dispersible tablets should be taken on an empty stomach (at least 30 minutes before food), and the film-coated tablets and granules can be taken on an empty stomach or with a light meal.
Disperzibilne tablete je treba jemati na prazen želodec (vsaj 30 minut pred zaužitjem hrane), filmsko obložene tablete in zrnca pa je mogoče vzeti na prazen želodec ali z lahkim obrokom.
The granules are sprinkled on soft food such as yogurt or apple sauce that the patient can eat.
Zrnca se primešajo mehki hrani, kot sta jogurt ali jabolčna kaša, ki jo bolnik lahko poje.
It is available as film-coated tablets, dispersible tablets and granules.
Na voljo je v obliki filmsko obloženih tablet, disperzibilnih tablet in zrnc.
The active substance in Exjade, deferasirox, is an ‘iron chelator'.
Zdravilna učinkovina v zdravilu Exjade, deferasiroks, je „kelator železa“.
In chronic iron overload due to blood transfusions, one main study compared Exjade with deferoxamine in 591 patients with beta thalassaemia major.
Pri kronični preobremenitvi z železom zaradi transfuzij krvi so v eni glavni študiji zdravilo Exjade primerjali z deferoksaminom pri 591 bolnikih z beta talasemijo major.
The company will also perform the following studies: a study on the long-term effects of the filmcoated tablets and dispersible tablets in children aged over 10 years with non-transfusion-dependent thalassaemia; and a study to assess the safety of the film-coated tablets (particularly when they are crushed) in children.
Družba bo opravila tudi naslednje študije: študijo dolgoročnih učinkov filmsko obloženih tablet in disperzibilnih tablet pri otrocih z od transfuzije neodvisno talasemijo, starejših od 10 let, in študijo za proučitev varnosti filmsko obloženih tablet (zlasti, če so zdrobljene) pri otrocih.
Other common side effects (in up to 1 patient in 10) include nausea (feeling sick), vomiting, diarrhoea, indigestion, abdominal (belly) pain, constipation, headache, rash, itching, blood tests showing raised transaminases (which may suggest liver damage) and protein in urine.
Drugi pogosti neželeni učinki (ki se pojavijo pri največ 1 bolniku od 10) so navzeja (slabost), bruhanje, driska, prebavne težave, bolečine v trebuhu, zaprtost, glavobol, izpuščaj, srbenje, zvišane ravni transaminaz pri preiskavah krvi (ki bi lahko kazale na okvaro jeter) in beljakovine v urinu.