FrancophonIA/ELRC3.0 huggingface dataset:
English: In summary, the CHMP supported the proposal of the MAH which was “Humoral or cellular immune deficiency (primary or acquired), including hypogammaglobulinaemia, dysgammaglobulinaemia and AIDS or symptomatic HIV infection or an age-specific CD4+ T-lymphocyte percentage <25%”.
Maltese: Fil-qosor, is-CHMP appoġġja l-proposta tal-MAH li kienet “Defiċjenza immunitarja umorali jew ċellulari (pimarja jew akkwistata), inklużi l-ipogammaglobulinemija, id-disgammaglobulinemija u AIDS jew infezzjoni tal-HIV sintomatika jew perċentwal ta' limfoċiti CD4+ T speċifiku għall-età <25 %”. Madankollu, kien meqjus neċessarju li jkun inkluż %CD4+ speċifiku għall-età skont ilgwida tal-WHO minħabba li huwa indikat it-tilqim tat-tfal mill-età ta' disa' xhur 'il quddiem.
English: It was decided to delete the statement on pregnancy from 4.4 because according to the guideline on risk assessment of medicinal products on human reproduction and lactation: from data to labeling (EMEA/CHMP/203927/200), reference to pregnancy should only be made in section 4.3 and 4.6.
Maltese: Ġie deċiż li titneħħa d-dikjarazzjoni dwar it-tqala minn 4.4 peress li skont il-linja gwida dwar ilvalutazzjoni tar-riskju ta' prodotti mediċinali fuq ir-riproduzzjoni fil-bniedem u t-treddigħ: middejta għat-tikkettar (EMEA/CHMP/203927/200), ir-referenza għat-tqala għandha ssir biss fissezzjoni 4.3 u 4.6.
English: The theoretical teratogenic risk following rubella vaccination has been estimated to be 0.5% during the first trimester and is up to 1.6%, if the vaccine is given between 1-2 weeks before and 4-6 weeks after conception.
Maltese: Ir-riskju teratoġeniku teoretiku wara t-tilqim għar-rubella ġie stmat li huwa 0.5 % waqt l-ewwel tliet xhur u jitla' sa 1.6 %, jekk il-vaċċin jingħata bejn ġimgħa u ġimgħatejn qabel u erba' sa sitt ġimgħat wara t-tnissil.
English: The MAH implemented all comments made by the CHMP and the final agreed wording was: “There is limited experience with PRIORIX during breast-feeding.
Maltese: Il-MAH implimenta l-kummenti kollha magħmula mis-CHMP u l-kliem finali li kien hemm qbil dwaru kien: “Hemm esperjenza limitata bi PRIORIX waqt it-treddigħ.
English: Pharyngeal excretion of the rubella and measles virus is known to occur about 7 to 28 days after vaccination with peak excretion around the 11th day.
Maltese: It-tneħħija farinġali tal-virus tar-rubella u tal-ħosba hija magħrufa li sseħħ madwar sebgħa sa 28 jum wara t-tilqima bl-ogħla tneħħija tkun madwar il-11-il jum.
English: The data set provided by the MAH was generated by post-marketing data from the MAH's safety database and data from recent published literature about MMR vaccination in pregnant women.
Maltese: Is-sett ta' dejta pprovdut mill-MAH kien ipprovdut minn dejta ta' wara ttqegħid fis-suq fid-database tas-sigurtà tal-MAH u minn dejta minn letteratura ppubblikata dan laħħar dwar it-tilqim tal-MMR fin-nisa tqal.
English: The sentence was modified as per the QRD recommendation to read “PRIORIX has not been evaluated in fertility studies”.
Maltese: Is-sentenza nbidlet skont ir-rakkomandazzjoni tal-QRD u tinqara “PRIORIX ma ġiex evalwat flistudji dwar il-fertilità”.
English: The CHMP noted that there are no theoretical risks of vaccination during breastfeeding.
Maltese: Is-CHMP innota li m'hemmx riskji teoretiċi ta' tilqim waqt it-treddigħ.
English: A seropositive response by ELISA may not necessarily represent protection, especially for mumps.
Maltese: Rispons seropożittiv minn ELISA ma jirrappreżentax neċessarjament protezzjoni, b'mod speċjali għall-gattone.
English: In order to get more insight in possible harm of MMR vaccination during pregnancy or pre-conception the CHMP asked from the MAH to provide evidence from enhanced surveillance and controlled studies that focus on risk of spontaneous abortion in women susceptible to measles, mumps and/or rubella, risk of malformation and congenital rubella syndrome (CRS) in offspring of such women, follow-up data up to 1 year age of children born from rubella susceptible women.
Maltese: Sabiex jikseb aktar għarfien dwar ilħsara possibbli li jista' jikkawża t-tilqim tal-MMR waqt it-tqala jew qabel it-tnissil is-CHMP talab lillMAH jipprovdi evidenza minn studji b'sorveljanza mtejba u kkontrollati li jiffukaw fuq ir-riskju ta' abort spontanju f'nisa suxxettibbli għall-ħosba, il-gattone u/jew ir-rubella, ir-riskju ta' malformazzjoni u ta' sindromu ta' rubella konġenitali (congenital rubella syndrome - CRS) fit-trabi ta' nisa bħal dawn, dejta dwar is-segwitu sa sena ta' tfal li jkunu twieldu lil nisa suxxettibbli għarrubella.
English: The CHMP agreed that the list of adverse reactions reported from clinical trials and post marketing experience was appropriately reflected in the proposed harmonized SmPC.
Maltese: Is-CHMP qabel li l-lista ta' reazzjonijiet avversi rrappurtati mill-provi kliniċi u l-esperjenza ta' wara t-tqegħid fis-suq kienet riflessa kif xieraq fl-SmPC armonizzat propost.
English: More recently Priorix has been coadministered with Haemophilus influenzae type b (Hib) and meningococcal C conjugate vaccines as well as with concomitant co-administration with hepatitis A inactivated vaccine and pneumoccocal 7-valent conjugate vaccine.
Maltese: Aktar reċenti Priorix ingħata flimkien ma' vaċċini talHaemophilus influenzae tat-tip b (Hib) u vaċċini konjugati meninġokokkali C kif ukoll ingħata flimkien mal-vaċċin mhux attivat tal-epatite A u mal-vaċċin konjugat pnewmokokkali 7-valenti.
English: Section 4.2 - Posology and method of administration For all countries, the dose of reconstituted Priorix vaccine is 0.5 ml.
Maltese: Sezzjoni 4.2 - Pożoloġija u metodu ta' kif għandu jingħata Għall-pajjiżi kollha, id-doża tal-vaċċin rikostitwit ta' Priorix hija ta' 0.5 ml.
English: A number of studies documented increased risk of developing mumps with increasing time after vaccination (Vandermeulen et al., 2004; Cortese et al., 2008; Castilla et al., 2009), and data from the United Kingdom indicate vaccine effectiveness may decrease with age, which probably also reflects increasing time from vaccination (Cohen et al., 2007).
Maltese: Cortese et al., 2008; Castilla et al., 2009), u dejta mir-Renju Unit tindika li l-effikaċja tal-vaċċin tista' tonqos aktar ma wieħed jikber fl-età, li aktarx jirrifletti t-tul ta' żmien minn meta wieħed ikun ħa t-tilqima (Cohen et al., 2007).
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.
Maltese: Dejta ppubblikata dwar nisa ta' età li jista' jkollhom it-tfal u li ngħataw it-tilqima fir-reġjun tal-Amerika Ċentrali u l-Amerika t'Isfel ma turi l-ebda riskju jew riskju żgħir ħafna (0-0.2 %) ta' CRS wara t-tilqim ta' nisa li ma kinux jafu li huma tqal b'vaċċin li kien fih ir-rubella.
English: Moreover, in the reference note for encephalitis the MAH was asked to add the risk of encephalitis after mumps infection, “mumps: 2-4 in 1000 cases”.
Maltese: Barra minn hekk, fin-nota ta' referenza għall-enċefalite l-MAH intalab iżid ir-riskju tal-enċefalite wara infezzjoni tal-gattone, “gattone: 2-4 f'1000 każ”.
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.
Maltese: Is-CHMP innota li minħabba li t-tilqim bil-vaċċin tal-ħosba, tal-gattone u tar-rubella huwa ġeneralment kontraindikat fin-nisa tqal hija disponibbli biss dejta limitata dwar l-abort spontanju, il-malformazzjonijiet u s-sindromu tar-rubella konġenitali fit-trabi wara t-tilqim bi Priorix.
English: Priorix is contraindicated in pregnancy but since there is currently no information to conclude that there is a teratogenic risk following vaccination with MMR vaccines the following wording was agreed: “PRIORIX is contraindicated during pregnancy (see section 4.3).
Maltese: Priorix huwa kontraindikat fit-tqala iżda minħabba li fil-preżent m'hemm l-ebda informazzjoni sabiex wieħed jikkonkludi li hemm riskju teratoġeniku wara t-tilqim bil-vaċċini tal-MMR kien hemm qbil dwar il-kliem li ġej: “PRIORIX huwa kontraindikat waqt it-tqala (ara sezzjoni 4.3).
English: In order to comply with the SmPC guideline the MAH proposed a list of the adverse reactions in line with the MedDRA system organ classification.
Maltese: Sabiex jikkonforma mal-linja gwida tal-SmPC il-MAH ippropona lista tar-reazzjonijiet avversi skont is-sistema tal-klassifika talorgani tal-MedDRA.
English: The main divergences between the proposed harmonized SmPC and national product information relates to the description of post marketing reports.
Maltese: Id-differenzi ewlenin bejn l-SmPC armonizzat propost u l-informazzjoni nazzjonali dwar il-prodott jirrigwardaw id-deskrizzjoni tar-rapporti ta' wara t-tqegħid fis-suq.
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).
Maltese: Barra minn hekk il-MAH ippropona li jħassar il-kliem dwar l-istudji komparattivi li urew inċidenza statistikament sinifikanti aktar baxxa ta' uġigħ, ħmura u nefħa fis-sit tal-injezzjoni bi Priorix meta mqabbel mal-prodott ta' referenza (Ipp et al., 2004;
English: The CHMP noted that the current clinical experience with Priorix is limited to children and no trials were performed in adolescents and adults.
Maltese: Is-CHMP innota li l-esperjenza klinika attwali bi Priorix hija limitata għat-tfal u ma saret l-ebda prova fl-adolexxenti u fl-adulti.
English: The approved lower age limit indicated for the use of Priorix varied from 9 months to 15 months across the individual EU member states reflecting in some cases the national recommendations for routine MMR vaccination.
Maltese: Il-limitu l-baxx tal-età approvat u indikat għall-użu ta' Priorix kien ivarja minn 9 xhur sa 15-il xahar fost l-Istati Membri individwali tal-UE li jirrifletti f'ċerti każijiet ir-rakkomandazzjonijiet nazzjonali għat-tilqim ta' rutina tal-MMR.
English: The WHO classification of HIV-related disease in adults and children published in 2006 states the following: “Immunological criteria for diagnosing advanced HIV in a child younger than five years of age with severe HIV infection: %CD4+ <25 among those younger than 12 months %CD4+ <20 among those aged 12-35 months %CD4+ <15 among those aged 36-59 months”
Maltese: Il-klassifikazzjoni tal-WHO dwar il-mard relatat mal-HIV fl-adulti u fit-tfal ippubblikata fl-2006 tgħid dan li ġej: “Il-kriterji immunoloġiċi għad-dijanjosi tal-HIV avvanzata f'tifel jew tifla ta' inqas minn ħames snin b'infezzjoni severa tal-HIV:
English: More specifically: “For use in children between 9 to 12 months of age see sections 4.2, 4.4 and 5.1.” The MAH had also included in this section the sentence “The use of PRIORIX should be based on official recommendations.” but the CHMP agreed to move it at the beginning of section 4.2 Posology and method of administration because as per the guideline on SmPC dated September 2009 the reference to official recommendations should be made under section 4.2.
Maltese: B'mod aktar speċifiku: “Għall-użu fit-tfal ta' bejn id-disa' u t-12-il xahar ara s-sezzjonijiet 4.2, 4.4 u 5.1.” F'din is-sezzjoni l-MAH kien inkluda wkoll is-sentenza “L-użu ta' PRIORIX għandu jkun ibbażat fuq rakkomandazzjonijiet uffiċjali.” iżda s-CHMP qabel li jqiegħda fil-bidu tas-sezzjoni 4.2 Pożoloġija u metodu ta' kif għandu jingħata minħabba li skont il-linja gwida dwar l-SmPC datata Settembru 2009 ir-referenza għar-rakkomandazzjonijiet uffiċjali għandha ssir taħt is-sezzjoni 4.2.
English: The MAH was however asked to consider restructuring section 4.8 in accordance with the SmPC guideline to provide clear and readily accessible information (summary of the safety profile, tabulated list of adverse reactions, description of selected adverse reactions).
Maltese: Il-MAH madankollu ntalab jikkunsidra l-istrutturar mill-ġdid tas-sezzjoni 4.8 skont il-linja gwida tal-SmPC sabiex jipprovdi informazzjoni ċara u faċilment aċċessibbli (sommarju tal-profil ta' sigurtà, lista tabulata tarreazzjonijiet avversi, deskrizzjoni ta' għażla ta' reazzjonijiet avversi).
English: The Advisory Committee on Immunization Practices (ACIP) shortened its recommended period in 2001 to avoid pregnancy after receipt of rubella-containing vaccine from 3 months to 28 days because no case of CRS had been identified among infants born to women who were vaccinated inadvertently against rubella within 3 months or early in pregnancy (Center for Disease Control and Prevention, 2001).
Maltese: Il-Kumitat Konsultattiv dwar il-Prattiki tal-Immunizzazzjoni (Advisory Committee on Immunization Practices - ACIP) qassar il-perjodu ta' rakkomandazzjoni tiegħu fl-2001 sabiex tkun evitata t-tqala wara li persuna tingħata l-vaċċin li fih ir-rubella minn tliet xhur għal 28 ġurnata minħabba li ma kien ġie identifikat l-ebda każ ta' CRS fost it-trabi li twieldu lil nisa li tlaqqmu b'mod aċċidentali kontra r-rubella fi żmien tliet xhur jew kmieni fit-tqala (Ċentru għall-Kontroll u lPrevenzjoni tal-Mard, 2001).
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.
Maltese: Mill-każijiet innotifikati fl-2010, kważi 30% iddaħħlu l-isptar u kienet osservata severità akbar tal-marda fittrabi ta' taħt is-sena u fl-adulti ta' aktar minn 20 sena, bi proporzjonijiet rispettivi ta' każijiet li ddaħħlu l-isptar ta' 38% u 46%.
English: Mumps vaccine efficacy has also been suggested to be lower in high-transmission settings (Brockhoff 2004).
Maltese: Ġie ssuġġerit ukoll li l-effikaċja tal-vaċċin tal-gattone hija aktar baxxa f'ambjenti fejn hemm trażmissjoni għolja (Brockhoff 2004).
English: In addition as there was one inconsistency with the package leaflet the MAH was asked to add “atypical mild or attenuated measles” in section 4.8 under infections and infestations.
Maltese: Barra minn hekk minħabba li kien hemm nuqqas ta' konsistenza mal-fuljett ta' tagħrif il-MAH intalab iżid “ħosba atipika ħafifa jew attenwata” fis-sezzjoni 4.8 taħt infezzjonijiet u infestazzjonijiet.
English: In addition experiences with other MMR or MMRV (measles, mumps, rubella, varicella) vaccines do not indicate any negative impact on the immune response or safety profile following intramuscular injection.
Maltese: Barra minn hekk l-esperjenzi b'vaċċini oħrajn tal-MMR jew tal-MMRV (ħosba, gattone, rubella, ġidri r-riħ) ma jindikawx xi effett negattiv fuq irrispons immunitarju jew il-profil tas-sigurtà wara l-injezzjoni fil-muskolu.
English: The CHMP recommended reordering of some of the statements and adding subtitles to clearly distinguish each precaution (i.e. thrombocytopenia, immunocompromised patients, and transmission).
Maltese: Is-CHMP irrakkomanda r-riformulazzjoni ta' xi wħud mid-dikjarazzjonijiet u ż-żieda ta' sottotitoli sabiex ikun hemm distinzjoni ċara bejn kull prekawzjoni (jiġifieri tromboċitopenja, pazjenti immunokompromessi, u t-trażmissjoni).
English: During the CHMP discussion it was questioned whether “pregnancy” should continue to be stated under contraindications.
Maltese: Waqt id-diskussjoni tas-CHMP ġie mistoqsi jekk it-“tqala” għandhiex tibqa' tkun iddikjarata taħt il-kontraindikazzjonijiet.
English: Based on the assessment of all data, the Marketing Authorisation Holder (MAH) proposed to align the indication of Priorix to children aged from 9 months old using the following wording: “PRIORIX is indicated for the active immunisation of children from the age of 9 months or older, adolescents and adults against measles, mumps and rubella.”
Maltese: Skont il-valutazzjoni tad-dejta kollha, id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq (MAH) ippropona li jallinja l-indikazzjoni ta' Priorix għat-tfal minn disa' xhur bl-użu ta' dan il-kliem: “PRIORIX huwa indikat għat-tilqim attiv ta' tfal minn disa' xhur jew aktar, adolexxenti u adulti kontra l-ħosba, il-gattone u r-rubella.
English: Organisation (WHO) to routinely vaccinate potentially susceptible, asymptomatic HIV positive children and adults.
Maltese: (WHO) tirrakkomanda li tfal u adulti pożittivi għall-HIV, potenzjalment suxxettibbli u mingħajr sintomi għandhom jitlaqqmu regolarment.
English: Though available data in the literature highlight a valuable perspective with regard to the overall risk of vaccine exposure at various stages of pregnancy, the theoretical risk, and because it is impossible to prove that the risk is zero, the MAH proposed that known pregnancy remains a contraindication to administration of rubella-containing vaccine.
Maltese: Għalkemm id-dejta disponibbli fil-letteratura tenfasizza perspettiva siewja fir-rigward tar-riskju ġenerali tal-espożizzjoni għall-vaċċin fi stadji differenti tat-tqala, ir-riskju teoretiku, u minħabba li huwa impossibbli li wieħed juri li r-riskju huwa żero, il-MAH ippropona li t-tqala kkonfermata tibqa' kontraindikazzjoni għall-għoti tal-vaċċin li fih ir-rubella.
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.
Maltese: Il-MAH bidel xi ftit it-test propost u l-kliem finali li qabel miegħu s-CHMP huwa: “Ġew irrappurtati każijiet ta' aggravar ta' tromboċitopenja u każijiet ta' ripetizzjoni ta' tromboċitopenja f'pazjenti li sofrew minn tromboċitopenja wara l-ewwel doża wara t-tilqim b'vaċċini ħajjin tal-ħosba, tal-gattone u tar-rubella.
English: The CHMP noted that for the majority of clinical trials investigating co-administration of Priorix with other vaccines no CSRs are available but only literature references.
Maltese: Is-CHMP innota li fil-parti l-kbira tal-provi kliniċi li investigaw l-għoti ta' Priorix ma' vaċċini oħrajn m'hemmx CSRs disponibbli iżda biss referenzi għal-letteratura.
English: Inadvertent vaccination of unknowingly pregnant women with PRIORIX should not be a reason for termination of pregnancy”.
Maltese: It-tilqim aċċidentali ta' nisa li ma jkunux jafu li huma tqal bi PRIORIX m'għandux ikun raġuni għat-terminazzjoni tat-tqala”.
English: Because of the much higher likelihood of thrombocytopenia after natural infection, the benefits of vaccination most often exceed the risks of severe symptomatic thrombocytopenia caused by immunization.
Maltese: Minħabba l-possibbiltà akbar ta' tromboċitopenja wara infezzjoni naturali, il-benefiċċji tat-tilqim spiss jisbqu r-riskji ta' tromboċitopenja sintomatika severa kkawżata mit-tilqim.
English: Natural rubella infection can have a devastating impact on pregnancy, leading to foetal death, premature delivery and an array of congenital defects.
Maltese: L-infezzjoni naturali tar-rubella jista' jkollha effett devastanti fuq it-tqala, li jwassal għall-mewt talfetu, ħlas qabel iż-żmien u firxa ta' difetti konġenitali.
English: The final agreed wording is: “Women who intend to become pregnant should be advised to delay for 1 month following PRIORIX vaccination.
Maltese: Il-kliem finali li kien hemm qbil dwaru huwa: “Nisa li għandhom il-ħsieb li joħorġu tqal għandhom ikunu avżati li jistennew xahar wara t-tilqima bi PRIORIX.
English: Priorix is nationally approved in 20 countries and is approved through the mutual recognition procedure (MRP) in 9 countries.
Maltese: Priorix huwa approvat nazzjonalment f'20 pajjiż u huwa approvat permezz tal-Proċedura ta' Rikonoxximent Reċiproku (MRP) f'disa' pajjiżi.
English: The final agreed wording is: “Transmission of measles and mumps virus from vaccinees to susceptible contacts has never been documented.
Maltese: Il-kliem finali li kien hemm qbil dwaru huwa: “It-trażmissjoni tal-virus tal-ħosba u tal-gattone minn dawk li jitlaqqmu lil kuntatti suxxettibbli qatt ma ġiet iddokumentata.
English: The attenuated virus strain in the current rubella vaccine can rarely infect the foetus and there is no evidence that foetal infection with the vaccine virus is harmful.
Maltese: Ir-razza tal-virus attenwat filvaċċin attwali tar-rubella rarament jista' jaffettwa lill-fetu u m'hemm l-ebda evidenza li l-infezzjoni tal-fetu bil-virus tal-vaċċin huwa ta' ħsara.
English: The MAH was asked to add some information on this issue.
Maltese: Il-MAH intalab iżid xi ftit informazzjoni dwar din il-kwistjoni.
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.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
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).
Maltese: Jiġi bħala soluzzjoni orali (80 mg/ml), trab għal soluzzjoni orali (qratas ta' 100 mg), kapsuli (100 mg) u pilloli (100 mg).
English: Norvir is a medicine that contains the active substance ritonavir.
Maltese: Norvir hu mediċina li fiha s-sustanza attiva ritonavir.
English: The standard dose for adults is 100 or 200 mg, once or twice a day.
Maltese: Iddoża standard għall-adulti hi ta' 100 jew 200 mg, darba jew darbtejn kuljum.
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.
Maltese: Meta jintuża bħala mediċina kontra l-HIV, l-effetti sekondarji l-aktar komuni b'Norvir (li dehru f'aktar minn pazjent 1 minn kull 10) huma diżgweżja (telf tat-togħma), paraestesija (sensazzjonijiet tattnemnim anomali) madwar il-ħalq u fil-ġogi, uġigħ ta' ras, studament, newropatija periferika (ħsara estrema lin-nervituri), farinġite (griżmejn misluħa), uġigħ fil-ħalq u fil-griżmejn, sogħla, uġigħ addominali (uġigħ fl-istonku), nawżja (dardir), dijarrea, remettar, dispepsija (indiġestjoni), prurite (ħakk), raxx, uġigħ fil-ġogi u fid-dahar, għeja, ħmura u tħoss is-sħana.
English: This is a summary of the European public assessment report (EPAR) for Norvir.
Maltese: Dan id-dokument huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Norvir.
English: Norvir can be used as a ‘‘pharmacokinetic enhancer' (booster' to increase the blood levels of other antiviral medicines that belong to the same group as Norvir (protease inhibitors) called amprenavir, atazanavir, fosamprenavir, lopinavir, saquinavir, tipranavir and darunavir.
Maltese: Norvir jista' jintuża bħala ‘‘buwster farmakokinetiku" (buwster biex iżid il-livelli tad-demm ta' mediċini antivirali oħra li jappartjenu għall-istess grupp bħal dak ta' Norvir (inibituri tal-proteażi) msejħa lamprenavir, l-atazanavir, il-fosamprenavir, il-lopinavir, is-sakuinavir, it-tipranavir u d-darunavir.
English: Norvir has been studied as an antiviral medicine in two main studies involving 1,446 patients.
Maltese: Norvir ġie studjat bħala mediċina antivirali f'ż ewġ studji ewlenin, li fihom ħadu sehem 1,446 pazjent.