FrancophonIA/ELRC3.0 huggingface dataset:
English: The MAH performed all the above changes but in order to be consistent with the SmPCs of all GSK vaccines the MAH asked to continue presenting adverse reactions as a list keeping a separation between the adverse reactions reported in clinical trials and the adverse reaction reported in postmarketing.
Slovenian: Imetnik dovoljenja za promet z zdravilom je vnesel vse zgoraj navedene spremembe, vendar je zaradi skladnosti povzetkov z glavnimi značilnostmi zdravila za vsa cepiva GSK prosil, če lahko še naprej predstavlja neželene učinke v obliki seznama in posebej navaja neželene učinke, o katerih so poročali v kliničnih preskušanjih, in neželene učinke, o katerih so poročali v obdobju trženja.
English: Priorix is indicated for the active immunisation against measles, mumps and rubella.
Slovenian: Cepivo Priorix je indicirano za aktivno imunizacijo proti ošpicam, mumpsu in rdečkam.
English: To be in line with current WHO recommendations the CHMP was of the opinion that delay in pregnancy should be changed from 3 months to 1 month after vaccination.
Slovenian: Zaradi skladnosti s trenutnim priporočilom SZO je CHMP menil, da je treba navodilo o izogibanju zanositvi spremeniti s 3 mesecev na 1 mesec po cepljenju.
English: Studies have shown that breast-feeding postpartum women vaccinated with live attenuated rubella vaccines may secrete the virus in breast milk and transmit it to breast-fed infants without evidence of any symptomatic disease.
Slovenian: Študije so pokazale, da se lahko pri poporodnih ženskah, ki dojijo, cepljenih z živim oslabljenim cepivom rdečk, virus izloča v materino mleko in prenese na dojenega otroka brez znakov simptomatske bolezni.
English: In the SmPC of Bulgaria, Cyprus, Estonia, Malta and the United Kingdom, it is stated that pregnancy must be avoided for one month after vaccination as compared to the three months in the SmPC of the countries involved in the MRP and other countries.
Slovenian: V povzetkih glavnih značilnosti zdravila za Bolgarijo, Ciper, Estonijo, Malto in Združeno kraljestvo je navedeno, da naj ženske ne zanosijo en mesec po cepljenju, medtem ko je v povzetkih glavnih značilnosti zdravila držav, ki so zdravilo odobrile v postopku z medsebojnim priznavanjem, in drugih državah, navedeno tri mesece.
English: The CHMP also noted that there are some published data at present that could justify the lifting of the absolute contraindication for pregnant women from MMR vaccines as it is believed that although the vaccination of pregnant women is not recommended, in some individual cases the benefit of vaccination of a pregnant woman might outweigh the risk.
Slovenian: CHMP je ugotovil tudi, da obstaja nekaj objavljenih podatkov, ki bi lahko upravičili odpravo absolutne kontraindikacije cepiv MMR pri nosečnicah, saj prevladuje mnenje, da so lahko koristi cepljenja za nosečnice v nekaterih premerih večje od tveganja, čeprav se cepljenje nosečnic ne priporoča.
English: The MAH proposed to use a general sentence and not to list the different vaccines.
Slovenian: Imetnik dovoljenja za promet z zdravilom je predlagal uporabo splošnega stavka brez navajanja različnih cepiv.
English: Also for clarity, the CHMP agreed to replace the company's proposal “In such cases, the risk-benefit of immunising with Priorix should be carefully evaluated” by “Patients with existing thrombocytopenia or a history of thrombocytopenia after measles, mumps or rubella vaccination should be immunized with caution”
Slovenian: Zaradi jasnosti se je CHMP strinjal, da se stavek, ki ga je predlagala družba, „V takih primerih je treba razmerje med tveganji in koristmi imunizacije s cepivom Priorix skrbno oceniti„ nadomesti z „Bolnike z obstoječo trombocitopenijo ali s trombocitopenijo po cepljenju proti ošpicam, mumpsu ali rdečkam v anamnezi je treba previdno imunizirati.“
English: However there is no evidence of transmission of these excreted vaccine viruses to susceptible contacts.
Slovenian: Vendar ni dokazov, da bi se virusa, ki se izločata iz cepiva, s stikom prenesla na dovzetne posameznike.
English: Accordingly to the SmPC guideline, the SmPC provides information on a particular medicinal product; therefore it should not include reference to other medicinal products.
Slovenian: V skladu s smernicami za povzetek glavnih značilnosti zdravila so v povzetku glavnih značilnosti zdravila informacije o določenih zdravilih, zato naj ne vključuje sklicev na druga zdravila.
English: Finally, the wording “adverse events” was replaced by “adverse reactions” in all the section as per the QRD comments.
Slovenian: B Izraz „neželeni dogodki“ je bil v vseh poglavjih v skladu z opombami QRD zamenjan z izrazom „neželeni učinki“ ..
English: The final agreed wording is: “Transmission of measles and mumps virus from vaccinees to susceptible contacts has never been documented.
Slovenian: Dogovorjeno je bilo naslednje končno besedilo: „Ni dokumentirano, da se virus ošpic in mumpsa s cepljenih posameznikov prenaša na dovzetne osebe.
English: However, since studies have not been conducted with Priorix in pregnant women the MAH proposed that pregnancy should be avoided 3 months after vaccination.
Slovenian: Vendar pa s cepivom Priorix pri nosečnicah niso izvedli nobenih študij, zato je imetnik dovoljenja za promet z zdravilom predlagal, da naj ženske ne zanosijo še 3 mesece po cepljenju.
English: Of the notified cases in 2010, almost 30% were hospitalized and a higher severity of the disease was observed in infants under one year of age and adults above 20 years, with respective proportions of hospitalised cases of 38% and 46%.Vaccination of children from 9 months onwards is therefore one tool to contain such outbreaks.
Slovenian: Od priglašenih primerov je bilo v letu 2010 skoraj 30 % hospitalizacij, pri čemer je bila pri dojenčkih, starih manj kot eno leto, in odraslih, starih več kot 20 let, oblika bolezni hujša, in sicer je bilo med prvimi hospitaliziranih 38 %, med drugimi pa 46 % bolnikov.
English: Published data from women of childbearing age that were vaccinated in the region of Central and South America demonstrate no or a negligible risk (0-0.2%) for CRS following vaccination of unknowingly pregnant women with a rubella containing vaccine.
Slovenian: Objavljeni podatki za ženske v rodni dobi, cepljene na območju srednje in južne Amerike, kažejo, da tveganja za KSR po cepljenju žensk, ki niso vedele, da so noseče, s cepivom, ki je vsebovalo virus rdečk, ni ali je zanemarljivo (0-0,2 %).
English: Mumps and rubella vaccine viruses have not been recognized to cause serious complications in HIV-infected persons, but as they are unlikely to benefit and complications could occur severely immunocompromised persons should not be vaccinated.
Slovenian: Ni bilo ugotovljeno, da bi virusi cepiv proti mumpsu in rdečkam povzročili hude zaplete pri bolnikih, okuženih z virusom HIV, vendar teh bolnikov ne cepimo, saj ni verjetno, da bi imeli od tega koristi, pri osebah s hudo oslabljenim imunskim sistemom pa bi se lahko pojavili tudi zapleti.
English: The MAH stated that there is insufficient experience in the use of Priorix in breastfeeding women and that vaccination of breastfeeding women can be considered if the benefit of vaccination outweighs the risk.
Slovenian: Imetnik dovoljenja za promet z zdravilom je navedel, da ni dovolj izkušenj z uporabo cepiva Priorix pri ženskah, ki dojijo, in da pri doječih ženskah pride cepljenje v poštev, če koristi cepljenja presegajo tveganja, ki so z njim povezana.
English: The MAH slightly modified the proposed text and the final wording agreed by the CHMP is: “Cases of worsening of thrombocytopenia and cases of recurrence of thrombocytopenia in subjects who suffered thrombocytopenia after the first dose have been reported following vaccination with live measles, mumps and rubella vaccines.
Slovenian: Imetnik dovoljenja za promet z zdravilom je nekoliko spremenil predlagano besedilo, tako da je končno besedilo sprejeto v soglasju z odborom CHMP: „Poročali so o primerih poslabšanja trombocitopenije in primerih ponovnega pojava trombocitopenije pri posameznikih, pri katerih se je trombocitopenija pojavila po prvem cepljenju s cepivom z živimi virusi ošpic, mumpsa in rdečk.
English: Because of this theoretical teratogenic risk, the WHO recommended in 2011 that rubella vaccination of pregnant women should be avoided in principle, and women who intend to become pregnant should be advised to delay for 1 month following rubella vaccination.
Slovenian: Zaradi tega teoretičnega teratogenega tveganja je SZO leta 2011 priporočila, da se nosečnice načeloma ne cepijo s cepivi proti rdečkam, ženskam, ki nameravajo zanositi, pa je treba svetovati, da še 1 mesec po cepljenju proti rdečkam ne zanosijo.
English: The paragraph on immunosuppression proposed by the MAH was considered outdated by the CHMP and a rewording was proposed.
Slovenian: CHMP meni, da je odstavek, ki ga je imetnik dovoljenja za promet z zdravilom predlagal o imunosupresiji, zastarel, zato je predlagal spremenjeno besedilo.
English: The CHMP noted that because of this theoretical teratogenic risk, the WHO recommended in 2011 that rubella vaccination of pregnant women should be avoided in principle, and women who intend to become pregnant should be advised to delay for 1 month following rubella vaccination.
Slovenian: CHMP je ugotovil, da je zaradi tega teoretičnega teratogenega tveganja SZO leta 2011 priporočila, da se nosečnic načeloma ne sme cepiti s cepivi virusa rdečk, ženskam, ki nameravajo zanositi, pa je treba svetovati, da še 1 mesec po cepljenju proti rdečkam ne zanosijo.
English: Therefore a second dose given preferable 3 months after the first dose is mandatory in this age group to ensure appropriate protection against measles, mumps and rubella.
Slovenian: Zato je treba za zagotovitev ustrezne zaščite pred ošpicami, mumpsom in rdečkami v tej starostni skupini obvezno uporabiti še drugi odmerek, najbolje 3 mesece po prvem odmerku.
English: delete wording about age of vaccination (covered in section 4.2) The Company also suggested rephrasing the paragraph about the idiopathic thrombocytopenic purpura (ITP).
Slovenian: Družba je predlagala tudi preoblikovanje besedila odstavka o idiopatični trombocitopenični purpuri (ITP).
English: In addition the MAH proposed to delete the wording about comparative studies that demonstrated a statistically significant lower incidence of pain, redness and swelling at the injection site with Priorix compared to the reference product (Ipp et al., 2004; Ipp et al., 2006; Knutsson et al., 2006; Taddio et al., 2009; Wellington and Goa, 2003).
Slovenian: Zaradi skladnosti s smernicami za povzetek glavnih značilnosti zdravila je imetnik dovoljenja za promet z zdravilom predlagal seznam neželenih učinkov v skladu z razvrstitvijo po organskih sistemih MedDRA. Imetnik dovoljenja za promet z zdravilom je predlagal tudi črtanje besedila o primerjalnih študijah, ki so dokazale značilno nižjo pojavnost bolečine, rdečine in otekline na mestu injiciranja s cepivom Priorix v primerjavi z referenčnim zdravilom (Ipp et al., 2004; Ipp et al., 2006; Knutsson et al., 2006; Taddio et al., 2009; Wellington and Goa, 2003).
English: An association between lack of measles-specific antibodies after vaccination and low CD+ T-lymphocyte counts (<600cells/mm3) was reported in published studies (Moss et al. 2003).
Slovenian: V objavljenih študijah (Moss et al. 2003) poročajo o povezavi med pomanjkanjem protiteles proti ošpicam po cepljenju in majhnim številom celic CD+ T-limfocitov (< 600 celic/mm3).
English: With regard to the delay of vaccination in subject who have received human gammaglobulins or a blood transfusion the CHMP was of the opinion that a longer interval between immunoglobulin or other blood product and subsequent vaccination is recommended in case of administration of high dose such as the one given in patients with Kawasaki Disease (2g/kg).
Slovenian: Ni podatkov, ki bi podprli uporabo cepivo PRIORIX s katerimi koli drugimi cepivi.“ Glede poznejšega cepljenja oseb, ki so prejele transfuzijo humanih gamaglobulinov ali krvi, je bil CHMP mnenja, da je treba v primeru velikih odmerkov, denimo takih, kot jih prejemajo bolniki s Kawasakijevo boleznijo (2 g/kg), priporočiti daljši interval med transfuzijo imunoglobulina ali drugih krvnih pripravkov in cepljenjem.
English: The summary of product characteristics (SmPC) adopted in the member states in the MRP and the member states in the national procedures are slightly different.
Slovenian: Povzetek glavnih značilnosti zdravila, ki je bil sprejet v državah članicah v postopku z medsebojnim priznavanjem, se nekoliko razlikuje od nacionalno odobrenih povzetkov glavnih značilnosti zdravila v državah članicah.
English: The CHMP noted that since vaccination of measles, mumps rubella vaccine is generally contraindicated in pregnant women only limited data of spontaneous abortion, malformations and congenital rubella syndrome in the offspring following vaccination with Priorix are available.
Slovenian: CHMP je ugotovil, da so podatki o spontanih splavih, malformacijah in kongenitalnem sindromu rdečk pri potomstvu žensk, cepljenih s cepivom Priorix, omejeni, saj je cepljenje proti ošpicam, mumpsu in rdečkam pri nosečnicah načeloma kontraindicirano.
English: The method of administration of Priorix is subcutaneous injection, although it can also be given by intramuscular injection.
Slovenian: Odmerek rekonstituiranega cepiva Priorix je za vse države 0,5 ml. Cepivo Priorix se daje v obliki subkutane injekcije, čeprav se ga lahko injicira tudi intramuskularno.
English: Nervous System (CNS) disorders be reworded as follows “Due caution should be employed in administration of PRIORIX to individuals with Central Nervous System (CNS) disorder, susceptibility to febrile convulsions or family history of convulsions.
Slovenian: Ker ni razpoložljivih podatkov o imunogenosti glede vpliva profilaktične uporabe antipiretikov, je bilo priporočeno, da se odstavek o cepljenju posameznikov z motnjami osrednjega živčnega sistema s cepivom Priorix preoblikuje sledeče: „Pri cepljenju posameznikov z motnjami osrednjega živčnega sistema, dovzetnostjo za vročinske krče ali s konvulzijami v družinski anamnezi je potrebna ustrezna previdnost.
English: Given the severe course of wild type measles infection in patients with advanced HIV infection, it is recommended by the World Health
Slovenian: Zaradi resnega poteka okužbe z ošpicami divjega tipa pri bolnikih z napredovalo okužbo z virusom HIV Svetovna zdravstvena organizacija (SZO) priporoča rutinsko cepljenje otrok in odraslih, okuženih z virusom HIV, ki ne kažejo simptomov, vendar so potencialno dovzetni za okužbo.
English: The MAH also proposed to add a specific sub-section on the paediatric population as per the SmPC guideline.
Slovenian: Imetnik dovoljenja za promet z zdravilom je predlagal tudi, da se v skladu s smernicami za povzetek glavnih značilnosti zdravila doda posebno podpoglavje za pediatrično populacijo.
English: The CHMP agreed that the sentence regarding fructose intolerance should change from “Patients with rare hereditary problems of fructose intolerance should not take this medicine.” to “Patients with rare hereditary problems of fructose intolerance should not be vaccinated with PRIORIX since it contains sorbitol”.
Slovenian: CHMP se je strinjal, da je treba stavek o intoleranci za fruktozo spremeniti iz „Bolniki z redko dedno intoleranco za fruktozo ne smejo prejeti tega zdravila.“ v „Bolniki z redko dedno intoleranco za fruktozo ne smejo biti cepljeni s cepivom PRIORIX, ker vsebuje sorbitol.“ Bilo je odločeno, da se navedba o nosečnosti v poglavju 4.4 briše, saj se v skladu s smernicami o oceni tveganja zdravila za sposobnost razmnoževanja in dojenje pri ljudeh - od podatkov do označevanja (EMEA/CHMP/203927/2005) - nosečnost navaja samo v poglavjih 4.3 in 4.6.
English: However, none of the field (outbreak) studies provided by the MAH
Slovenian: Vendar pa nobena terenska študija (o izbruhu), ki jo je predložil imetnik dovoljenja za promet z zdravilom, ni navajala podatkov, specifičnih za cepivo Priorix.
English: • the summary of products characteristic, labelling and package leaflet proposed by the marketing authorisation holder(s) have been assessed based on the documentation submitted and the scientific discussion within the Committee the CHMP has recommended the amendment of the marketing authorisations for which the summary of product characteristics, labelling and package leaflet are set out in Annex III for Priorix and associated names (see Annex I).
Slovenian: je CHMP priporočil dopolnitev dovoljenj za promet z zdravilom, za katere so v Prilogi III za zdravilo Priorix in povezana imena na voljo povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo (glejte Prilogo I).
English: Only if the child is confirmed or suspected to be immunodeficient, risks and benefits of vaccinating its lactating mother should be outweighed.
Slovenian: Razmerje med koristmi in tveganjem pri cepljenju doječe matere je treba pretehtati samo pri potrjeni imunski pomanjkljivosti otroka ali pri sumu nanjo.
English: These patients should be monitored carefully for signs of measles, parotitis and rubella.” Regarding the paragraph on transmission the proposal of the MAH was considered in principle acceptable by the CHMP with the addition that not only rubella but also measles pharyngeal excretion is known to appear.
Slovenian: Pri odstavku o prenosu bolezni je CHMP upošteval predlog imetnika dovoljenja za promet z zdravilom, da se doda besedilo o tem, da je znano, da se iz grla ne izloča samo virus rdečk, temveč tudi ošpic.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
Slovenian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom na dan.
English: The main measure of effectiveness was based on the number of patients whose disease got worse or who died.
Slovenian: Glavno merilo učinkovitosti je bilo število bolnikov, pri katerih se je bolezen poslabšala oziroma so umrli.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Norvir on 26 August 1996.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Norvir, veljavno po vsej Evropski uniji, izdala 26. avgusta 1996.
English: It should be taken with food.
Slovenian: Zdravilo je treba zaužiti skupaj s hrano.
English: What measures are being taken to ensure the safe and effective use of Norvir?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Norvir?
English: For younger patients, the recommended dose depends on the body surface area (calculated using the patient's height and weight).
Slovenian: Pri mlajših bolnikih je priporočeni odmerek odvisen od telesne površine (izračunane glede na telesno višino in maso bolnika).
English: The full EPAR for Norvir can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Norvir je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The recommended dose for adults (aged 18 years or over) is 600 mg twice a day.
Slovenian: Priporočeni odmerek zdravila za odrasle (stare 18 let ali več) je 600 mg dvakrat
English: This means that it blocks a viral enzyme called protease, which is involved in the reproduction of HIV.
Slovenian: To pomeni, da zavira virusni encim, imenovan proteaza, ki sodeluje pri razmnoževanju virusa HIV.
English: Other information about Norvir
Slovenian: Druge informacije o zdravilu Norvir
English: It is available as an oral solution (80 mg/ml), as a powder for oral solution (100 mg sachets), as capsules (100 mg) and as tablets (100 mg).
Slovenian: Na voljo je v obliki peroralne raztopine (80 mg/ml), praška za peroralno raztopino (100 mg vrečke), kapsul (100 mg) in tablet (100 mg).
English: This is a summary of the European public assessment report (EPAR) for Norvir.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Norvir.
English: The main measure of effectiveness was the change in the levels of HIV in the blood (viral load) and CD4 T cell levels in the blood (CD4 cell count).
Slovenian: Glavni merili učinkovitosti sta bili sprememba koncentracije virusa HIV v krvi (virusnega bremena) in raven T-celic CD4 v krvi (števila celic CD4).
English: A risk management plan has been developed to ensure that Norvir is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila Norvir je bil pripravljen načrt obvladovanja tveganj.
English: For more information about treatment with Norvir, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Norvir preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: This causes an increase of antiviral levels in the blood of such medicines and thus it boosts their antiviral activity.
Slovenian: Tako se poveča raven protivirusne učinkovine teh zdravil v krvi zviša, kar okrepi njihovo protivirusno dejavnost.
English: In the first study of Norvir as an antiviral medicine, 16% of the Norvir-treated patients (86 out of 543) experienced a worsening of disease or died, compared with 33% of the patients taking placebo (181 out of 547).
Slovenian: V prvi študiji zdravila Norvir kot protivirusnega zdravila je do poslabšanja ali smrti prišlo pri 16 % bolnikov (86 od 543), ki so se zdravili z zdravilom Norvir, v primerjavi s 33 % bolnikov (181 od 547), ki so jemali placebo.
English: What benefit has Norvir shown during the studies?
Slovenian: Kakšne koristi je zdravilo Norvir izkazalo med študijami?
English: When it is used as an HIV medicine, the most common side effects with Norvir (seen in more than 1 patient in 10) are dysgeusia (taste disturbances), paraesthesia (unusual tingling sensations) around the mouth and in the limbs, headache, dizziness, peripheral neuropathy (damage to the nerves in the limbs), pharyngitis (sore throat), mouth and throat pain, cough, abdominal pain (stomach ache), nausea (feeling sick), diarrhoea, vomiting, dyspepsia (heartburn), pruritis (itching), rash, joint and back pain, tiredness, flushing and feeling hot.
Slovenian: Kadar pa se zdravilo Norvir uporablja kot zdravilo proti virusu HIV, so njegovi najpogostejši neželeni učinki (opaženi pri več kot 1 bolniku od 10) disgevzija (motnje okušanja), parestezija (nenavadni občutki gomazenja) v predelu ust in v okončinah, glavobol, omotica, periferna nevropatija (poškodba živcev v okončinah), faringitis (vneto žrelo), bolečine v ustih in grlu, kašelj, bolečine v trebuhu, navzeja (občutek slabosti), driska, bruhanje, dispepsija (zgaga), pruritis (srbenje), izpuščaji, bolečine v sklepih in hrbtu, utrujenost, zardevanjein občutek vročine.
English: The CHMP decided that Norvir's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: CHMP je zaključil, da so koristi zdravila Norvir večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
English: Norvir is used in combination with other HIV medicines to treat patients over two years of age who are infected with human immunodeficiency virus type 1 (HIV 1), a virus that causes acquired immune deficiency syndrome (AIDS).
Slovenian: Zdravilo Norvir se uporablja v kombinaciji z drugimi zdravili za zdravljenje okužbe z virusom HIV pri bolnikih, starejših od dveh let, ki so okuženi z virusom humane imunske pomanjkljivosti tipa 1 (HIV-1), tj. virusom, ki povzroča sindrom pridobljene imunske pomanjkljivosti (aids).
English: Norvir has been studied as an antiviral medicine in two main studies involving 1,446 patients.
Slovenian: Zdravilo Norvir so raziskali v dveh glavnih študijah, ki sta vključevali 1 446 bolnikov.
English: Norvir does not cure HIV infection or AIDS, but it may delay the damage to the immune system and the development of infections and diseases associated with AIDS.
Slovenian: Zdravilo Norvir ne zdravi okužbe z virusom HIV ali aidsa, lahko pa upočasni slabšanje imunskega sistema ter razvoj okužb in bolezni, povezanih z aidsom.