FrancophonIA/ELRC3.0 huggingface dataset:
English: What is somatropin?
Maltese: X'inhu somatropin?
English: 27 February 2012
Maltese: 27 ta' Frar 2012
English: Outcome of procedures under Article 20 of Regulation (EC) No 726/2004 and Article 107 of Directive 2001/83/EC
Maltese: Riżultat tal-proċeduri skont l-Artikolu 20 tar-Regolament (KE) Nru 726/2004 u l-Artikolu 107 tad-Direttiva 2001/83/KE
English: The nationally authorised medicines are Genotropin, Humatrope, Maxomat, Norditropin, Saizen and Zomacton.
Maltese: Il-mediċini awtorizzati fuq livell nazzjonali huma Genotropin, Humatrope, Maxomat, Norditropin, Saizen u Zomacton.
English: EMA/966325/2011 Rev. 1 EMEA/H/A-107/1287
Maltese: 1 EMEA/H/A-107/1287
English: The CHMP concluded that the French SAGhE study had significant methodological limitations and that the results could not be considered robust.
Maltese: Is-CHMP ikkonkluda li l-istudju Franċiż SAGhE kellu limitazzjonijiet metodoloġiċi importanti u li rriżultati ma setgħux jitqiesu robusti.
English: Somatropin is a copy of naturally occurring human growth hormone, produced by a method known as ‘recombinant DNA technology'.
Maltese: Somatropin huwa kopja ta' ormon tat-tkabbir uman disponibbli b'mod naturali, prodott minn metodu magħruf bħala ‘teknoloġija rikombinanti tad-DNA'.
English: Which data has the CHMP reviewed?
Maltese: Liema dejta ġiet analizzata mis-CHMP?
English: 2 The centrally authorised somatropin-containing medicines are NutropinAq, Omnitrope and Valtropin.
Maltese: 2 Il-mediċini li fihom somatropin awtorizzati b'mod ċentrali huma NutropinAq, Omnitrope u Valtropin.
English: They have been authorised in the EU since the 1980s through centralised or national procedures.2 The approved indications vary for the different somatropin-containing medicines: they may be used as hormone replacement therapy, and to correct short stature (height) in children with certain genetic diseases (Turner syndrome or Prader Willi syndrome), children who have long-standing kidney problems and children born small for their gestational age.
Maltese: L-indikazzjonijiet approvati jvarjaw għall-mediċini differenti li fihom somatropin: jistgħu jintużaw bħala terapija ta' sostituzzjoni tal-ormoni, u sabiex jikkoreġu statura qasira (it-tul) fit-tfal b'ċertu mard ġenetiku (is-sindromu ta' Turner jew is-sindromu ta' Prader Willi), tfal li għandhom problemi fil-kliewi fit-tul u tfal li jitwieldu żgħar għall-età ġestazzjonali tagħhom.
English: The CHMP reviewed the available data on the safety of somatropin-containing medicines, including data from clinical trials, registries, and observational studies, as well as reports of side effects from post-marketing surveillance.
Maltese: Is-CHMP analizza d-dejta disponibbli dwar is-sikurezza ta' mediċini li fihom somatropin, inkluża dejta minn provi kliniċi, reġistri u studji ta' osservazzjoni kif ukoll rapporti ta' effetti kollaterali minn sorveljanza ta' wara t-tqegħid fis-suq.
English: In December 2010, the French medicines regulatory agency was made aware of preliminary results of a long-term population-based study in France of patients treated during childhood with somatropincontaining medicines.
Maltese: F'Diċembru 2010, l-aġenzija regolatorja tal-mediċini ta' Franza ġiet mgħarrfa dwar riżultati preliminari ta' studju fit-tul ibbażat fuq il-popolazzjoni fi Franza ta' pazjenti kkurati matul it-tfulija b'mediċini li fihom somatropin.
English: It looked at data on 10,000 adults who started treatment between 1985 and 1996, using a mandatory national registry.
Maltese: Osserva ddejta f'10,000 adult li bdew il-kura bejn l-1985 u l-1996, billi juża r-reġistru mandatorju nazzjonali.
English: The CHMP also looked into additional data from the unpublished French SAGhE study.
Maltese: Is-CHMP ra wkoll dejta addizzjonali mill-istudju Franċiż SAGhE li mhuwiex ippubblikat.
English: The study, called ‘Santé Adulte GH Enfant' (SAGhE) study, was initiated in October 2007 and aimed at improving knowledge on the safety and appropriateness of somatropin
Maltese: L-istudju, imsejjaħ ‘Santé Adulte GH Enfant' (SAGhE), beda f'Ottubru 2007 u kellu l
English: Why was somatropin reviewed?
Maltese: Għaliex ġie analizzat somatropin?
English: However, the Committee noted that the available data on the long-term effects of somatropin treatment are very limited.
Maltese: Madankollu, il-Kumitat osserva li d-dejta disponibbli fuq l-effetti fit-tul tat-trattament b'somatropin hija ferm limitata.
English: The risk appeared to be highest when doses higher than the ones approved were used.
Maltese: Irriskju deher li huwa l-ogħla meta ntużaw dożi ogħla minn dawk approvati.
English: An analysis in approximately 7,000 of those patients who were treated for growth hormone deficiency and for gestational or idiopathic short stature showed a possible increased risk of mortality with somatropin compared with the general population.
Maltese: Analiżi f'bejn wieħed u ieħor 7,000 minn dawk il-pazjenti li ġew ikkurati għad-defiċjenza tal-ormon tattkabbir u għal statura qasira ġestazzjonali jew idjopatika uriet possibbiltà ta' riskju miżjud ta' mortalità b'somatropin meta mqabbla mal-popolazzjoni ġenerali.
English: • Patients and healthcare professionals are reminded that the benefits of somatropin continue to outweigh its risks in the approved indications.
Maltese: • Il-pazjenti u l-professjonisti fil-qasam tas-saħħa huma mfakkra li l-benefiċċji ta' somatropin jibqgħu jegħlbu r-riskji tiegħu fl-indikazzjonijiet approvati.
English: In particular, an increased risk of mortality due to bone tumours and cardiovascular events (such as bleeding in the brain) was seen.
Maltese: B'mod partikolari, deher riskju akbar ta' mortalità minħabba tumuri tal-għadam u avvenimenti kardjovaskolari (bħal emorraġiji fil-moħħ).
English: Based on the evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the benefit-risk balance of somatropin-containing medicines remains positive when used in the approved indications at the approved doses.
Maltese: Fuq il-bażi tal-evalwazzjoni dwar id-dejta disponibbli bħalissa u d-diskussjoni xjentifika ġewwa lKumitat, is-CHMP ikkonkluda li l-bilanċ bejn il-benefiċċji u r-riskji ta' mediċini li fihom somatropin jibqa' pożittiv meta użat bl-indikazzjonijiet approvati fid-dożi approvati.
English: Medicines containing somatropin are given by injection.
Maltese: Il-mediċini li fihom somatropin jingħataw b'injezzjoni.
English: After assessing all other available safety data on somatropin, the CHMP concluded that the potential signal of an increased risk of mortality seen in the French study is not corroborated by any other data, and that the benefit-risk balance of somatropincontaining medicines has not changed.
Maltese: Wara li vvaluta d-dejta l-oħra kollha disponibbli fuq is-sikurezza dwar somatropin, is-CHMP ikkonkluda li s-sinjal potenzjali ta' riskju miżjud ta' mortalità muri fl-istudju Franċiż mhuwiex appoġġjat minn xi dejta oħra, u li l-bilanċ bejn il-benefiċċji u r-riskji ta' mediċini li fihom somatropin ma nbidilx.
English: In particular, the harmonised wording will emphasise that somatropin must not be used if there is any evidence of tumour activity, and that the maximum recommended daily dose should not be exceeded.
Maltese: B'mod partikolari, il-kliem armonizzat se jenfasizza li somatropin ma jistax jintuża jekk ikun hemm evidenza ta' attività ta' tumur, u li ma għandhiex tinqabeż id-doża massima rakkomandata ta' kuljum.
English: • Somatropin must not be used in patients with any evidence of tumour activity.
Maltese: • Somatropin ma jridx jintuża f'pazjenti li jkollhom xi evidenza ta' attività ta' tumur.
English: Consequently, in December 2010 the French agency asked the CHMP to issue an opinion on the impact of these data on the benefit-risk balance of somatropin-containing medicines, and on whether the marketing authorisation for these medicines should be maintained, varied, suspended or withdrawn across the EU.
Maltese: Konsegwentement, f'Diċembru 2010, l-aġenzija Franċiża talbet lis-CHMP sabiex joħroġ opinjoni dwar limpatt ta' dik id-dejta fuq il-bilanċ bejn il-benefiċċji u r-riskji ta' mediċini li fihom somatropin, u dwar jekk l-awtorizzazzjoni għat-tqegħid fis-suq għal dawk il-mediċini għandhiex tinżamm, tiġi modifikata, sospiża jew irtirata madwar l-UE.
English: 10 ml (3.5mg/ml) 5 vials
Maltese: 3 ml (3.5mg/ml) 1 pinna mimlija għal-lest kunjett (ħġieġ) 10 ml (3.5mg/ml) 1 kunjett kunjett (ħġieġ) 10 ml (3.5mg/ml) 5 kunjetti
English: Strength Pharmaceutical Form
Maltese: Isem (inventat) Qawwa Għamla farmaċewtika
English: 3 ml (3.5mg/ml) 1 pre-filled pen
Maltese: Il-pakkett li jmiss malprodott
English: The full EPAR for Mvasi 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: The cancer responded to treatment in 39% of those given Mvasi (128 of 328 patients) and 42% of those given Avastin (131 of 314).
Maltese: Ilkanċer irrisponda għall-kura f'39 % ta' dawk li ngħataw Mvasi (128 minn 328 pazjent), u f'42 % ta' dawk li ngħataw Avastin (131 minn 314-il pazjent).
English: Mvasi contains the active substance bevacizumab and is a ‘biosimilar medicine'.
Maltese: Mvasi fih is-sustanza attiva l-bevacizumab u huwa “mediċina bijosimili”.
English: The reference medicine for Mvasi is Avastin.
Maltese: Il-mediċina ta' referenza għal Mvasi hija Avastin.
English: Other information about Mvasi
Maltese: Informazzjoni oħra dwar Mvasi
English: Why is Mvasi approved?
Maltese: Għaliex ġie approvat Mvasi?
English: This is a summary of the European public assessment report (EPAR) for Mvasi.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Mvasi.
English: The most serious side effects are gastrointestinal perforation (hole in the gut wall), haemorrhage (bleeding) and arterial thromboembolism (blood clots in the arteries).
Maltese: L-effetti sekondarji l-aktar serji huma perforazzjoni gastrointestinali (toqba filmusrana), emorraġija (fsada) u tromboemboliżmu arterjali (koagulazzjoni fl-arterji).
English: What are the risks associated with Mvasi?
Maltese: X'inhuma r-riskji assoċjati ma' Mvasi?
English: Laboratory studies comparing Mvasi with Avastin have shown that the active substance in Mvasi is highly similar to that in Avastin in terms of structure, purity and biological activity.
Maltese: Studji fil-laboratorji li jqabblu Mvasi ma' Avastin urew li s-sustanza attiva f'Mvasi hija simili ħafna għal dik f'Avastin f'termini ta' struttura, purità u attività bijoloġika.
English: For more information on biosimilar medicines, see the question-and-answer document here.
Maltese: Għal aktar informazzjoni dwar il-mediċini bijosimili, ara d-dokument ta' mistoqsija u tweġiba hawn.
English: In addition, a study involving 642 patients with advanced non-small cell lung cancer showed that Mvasi was as effective as Avastin when given with the cancer medicines carboplatin and paclitaxel.
Maltese: Barra minn hekk, studju li involva 642 pazjent b'kanċer tal-pulmun avvanzat b'ċelloli mhux żgħar wera li Mvasi kien effettiv daqs Avastin meta ngħata mal-mediċini tal-kanċer carboplatin u paclitaxel.
English: • cancer of the ovary or associated structures (the fallopian tube that carries the egg from the ovary to the womb or the peritoneum, the membrane that lines the abdomen);
Maltese: • kanċer tal-ovarju jew strutturi assoċjati (it-tubu fallopjan li jġorr il-bajda mill-ovarju sal-utru jew ilperitonjum, il-membrana li tiksi l-addome);
English: The active substance in Mvasi, bevacizumab, is a monoclonal antibody (a type of protein) that has been designed to recognise and attach to vascular endothelial growth factor (VEGF), a protein that circulates in the blood and makes blood vessels grow.
Maltese: Is-sustanza attiva f'Mvasi, il-bevacizumab, hija antikorp monoklonali (tip ta' proteina), li tfassal sabiex jirrikonoxxi u jeħel mal-fattur ta' tkabbir endoteljali vaskulari (VEGF), proteina li tiċċirkola fid-demm u tkabbar il-vażi.
English: The dose is between 5 and 15 mg per kilogram body weight every two or three weeks, depending on the type of cancer being treated and the other cancer medicines being used.
Maltese: Id-doża hija bejn 5 u 15 mg għal kull kilogramma tal-piż talġisem kull ġimagħtejn jew tliet ġimgħat, skont it-tip ta' kanċer li jkun qed jiġi kkurat u l-mediċini l-oħra kontra l-kanċer li jkunu qed jintużaw.
English: This means that Mvasi is similar to a biological medicine (also known as the ‘reference medicine') that is already authorised in the European Union (EU).
Maltese: Dan ifisser li Mvasi huwa simili għal mediċina bijoloġika (magħrufa wkoll bħala ‘l-mediċina ta' referenza') li diġà hija awtorizzata flUnjoni Ewropea (UE).
English: The most common side effects with bevacizumab (which may affect more than 1 in 10 people) are hypertension (high blood pressure), tiredness or asthenia (weakness), diarrhoea and abdominal (belly) pain.
Maltese: L-effetti sekondarji l-aktar komuni b'bevacizumab (li jistgħu jaffettwaw aktar minn 1 minn kull 10) huma ipertensjoni (pressjoni tad-demm għolja), għeja jew astenija (dgħufija), dijarea u uġigħ addominali (fiż-żaqq).
English: Studies have also shown that giving Mvasi produces similar levels of the active substance in the body to giving Avastin.
Maltese: Studji wrew ukoll li l-għoti ta' Mvasi jipproduċi livelli simili tas-sustanza attiva fil-ġisem bħall-għoti ta' Avastin.
English: Mvasi is a cancer medicine that is used to treat adults with the following cancers:
Maltese: Mvasi huwa mediċina kontra l-kanċer li tintuża biex tikkura l-adulti li għandhom il-kanċers li ġejjin:
English: • cancer of the kidney (renal cell carcinoma) that is advanced or has spread elsewhere;
Maltese: • kanċer tal-kliewi (karċinoma fiċ-ċelloli tal-kliewi) li jkun avvanzat jew ikun infirex x'imkien ieħor;
English: For the full list of all side effects reported with Mvasi, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrappurtati b'Mvasi, ara l-fuljett ta' tagħrif.
English: Mvasi must not be used in people who are hypersensitive (allergic) to bevacizumab or any of the other ingredients, to Chinese hamster ovary cell products or other recombinant antibodies.
Maltese: Mvasi ma għandux jintuża f'persuni li huma sensittivi b'mod eċċessiv (allerġiċi) għal bevacizumab jew għal kwalunkwe waħda mis-sustanzi l-oħra, jew għall-prodotti li ġejjin miċ-ċelloli tal-ovarji tal-ħamster Ċiniż jew għal antikorpi rikombinanti oħra.
English: Tivicay is available as tablets (10, 25 and 50 mg).
Maltese: Tivicay jiġi bħala pilloli (10, 25 u 50 mg).
English: The full EPAR and risk management plan summary for Tivicay 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: Tivicay is an antiviral medicine containing the active substance dolutegravir.
Maltese: Tivicay huwa mediċina antivirali li fiha s-sustanza attiva dolutegravir.
English: • In the first of these, involving 822 patients, Tivicay once daily was compared with raltegravir (another integrase inhibitor), both given in combination with two other HIV medicines of a different class (known as nucleoside reverse transcriptase inhibitors or NRTIs): 88% (361 of 411 patients) given Tivicay and 85% (351 of 411) given raltegravir responded after 48 weeks of treatment.
Maltese: • Fl-ewwel studju, li fih ħadu sehem 822 pazjent, Tivicay darba kuljum tqabbel ma' raltegravir (inibitur ieħor tal-integrażi), it-tnejn mogħtija f'kombinazzjoni ma' żewġ mediċini oħra ta' klassi differenti kontra l-HIV (magħrufa bħala inibituri nukleosidiċi tat-transkrittażi inversa jew NRTIs): 88% (361 minn 411) li ngħataw Tivicay u 85% (351 minn 411) li ngħataw raltegravir irrispondew wara 48 ġimgħa ta' kura.
English: The active substance in Tivicay, dolutegravir, is an integrase inhibitor.
Maltese: Is-sustanza attiva f'Tivicay, dolutegravir, hija inibitur tal-integrażi.
English: Tivicay was demonstrated to be effective against HIV-1 in four main studies in adults.
Maltese: Tivicay intwera li huwa effettiv kontra l-HIV-1 f'erba' studji prinċipali fl-adulti.
English: This is a summary of the European public assessment report (EPAR) for Tivicay.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Tivicay.
English: Other information about Tivicay
Maltese: Informazzjoni oħra dwar Tivicay
English: Why is Tivicay approved?
Maltese: Għaliex ġie approvat Tivicay?
English: It is used together with other medicines to treat adults and children from 6 years of age who are infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Maltese: Jintuża flimkien ma' mediċini oħra għall-kura ta' adulti u tfal minn 6 snin 'il fuq infettati bil-virus tal-immunodefiċjenza umana tat-tip 1 (HIV-1), virus li jikkawża s-sindrome tad-defiċjenza immunitarja akkwiżita (AIDS).
English: Response rate at 48 weeks was 71% in patients given treatment based on Tivicay, and 64% in those given treatment based on raltegravir.
Maltese: Ir-rata ta' rispons wara 48 ġimgħa kienet ta' 71% fil-pazjenti li ngħataw kura bbażata fuq Tivicay, u 64% f'dawk li ngħataw kura bbażata fuq raltegravir.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Tivicay on 16 January 2014.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Tivicay fis-16 ta' Jannar 2014.
English: • The second study in previously treated patients involved 183 patients with infection resistant to previous treatment that had involved an integrase inhibitor (i.e. their infection was resistant to several classes of medicine, including previous integrase inhibitors): adding Tivicay twice daily to other treatment resulted in a response rate of 69% after 24 weeks of therapy.
Maltese: • It-tieni studju f'pazjenti kkurati preċedentament involva 183 pazjent bl-infezzjoni tkun reżistenti għal kuri preċedenti li invovlew inibitur tal-integrażi (i.e. l-infezzjoni tagħhom kienet reżistenti għal diversi klassijiet ta' mediċini, fosthom inibituri tal-integrażi preċedenti): biż-żieda ta' Tivicay darbtjen kuljum ma' kura oħra rriżulta f'rata ta' rispons ta' 69% wara 24 ġimgħa ta' terapija.
English: The response rate at 48 weeks was 88% (364 of 414 patients) in those given Tivicay-based treatment compared with 81% (338 of 419 patients) in those given Atripla.
Maltese: Ir-rata ta' rispons wara 48 ġimgħa kienet ta' 88% (364 minn 414-il pazjent) f'dawk li ngħataw kura bbażata fuq Tivicay meta mqabbla ma' 81% (338 minn 419-il pazjent/a) f'dawk li ngħataw Atripla.
English: What are the risks associated with Tivicay?
Maltese: X'inhuma r-riskji assoċjati ma' Tivicay?
English: The results indicated that similar levels of the medicine were produced in children to those seen in adults and adolescents, which should result in similar effectiveness.
Maltese: Ir-riżultati indikaw li livelli simili tal-mediċina kienu prodotti fit-tfal għal dawk li dehru fl-adulti u l-adoloxxenti, li għandu jirriżulta f'effikaċja simili.
English: • The second study involved 833 patients given either a combination of Tivicay with two NRTIs or a different three-drug combination (Atripla) that did not include an integrase inhibitor.
Maltese: • It-tieni studju involva 833 pazjent li ngħataw jew kombinazzjoni ta' Tivicay ma' żewġ NRTIs jew kombinazzjoni differenti ta' tliet mediċini (Atripla) li ma kinitx tinkludi inibitur tal-integrażi.
English: More serious adverse effects that have been reported include an uncommon but severe hypersensitivity (allergic) reaction with rash and possible effects on the liver.
Maltese: Effetti avversi aktar serji li ġew irrappurtati jinkludu reazzjoni (allerġika) mhux komuni iżda severa ta' ipersensittività b'raxx u effetti possibbli fuq il-fwied.
English: The dose for children 6 to 12 years old depends on the weight of the child; for those aged 12 and over it is usually one 50-mg tablet a day.
Maltese: Id-doża fit-tfal bejn 6 u 12-il sena tiddependi mill-piż tat-tifel jew tifla; għal dawk li għandom 12-il sena jew aktar ġeneralment hija ta' pillola waħda ta' 50 mg darba kuljum.
English: The medicine was generally well tolerated, although the CHMP noted the possible risk of infrequent but severe hypersensitivity reactions.
Maltese: B'mod ġenerali lmediċina kienet ittollerata tajjeb, għalkemm is-CHMP innota r-riskju possibbli ta' reazzjonijiet mhux frekwenti iżda severi ta' ipersensittività.
English: • The dose is one 50-mg tablet twice a day in patients whose virus is known or suspected to be resistant to integrase inhibitors; in these patients, giving Tivicay with medicines that decrease its effectiveness should be avoided.
Maltese: pillola waħda ta' 50 mg kuljum; iżda meta tingħata ma' ċerti mediċini li jnaqqsu l-effikaċja ta'
English: The company subsequently presented available results in 23 children from 6 to less than 12 years of age, who were given doses of Tivicay based on their body weight.
Maltese: Il-kumpanija sussegwentement ippreżentat ir-riżultati disponibbli fi 23 tifel u tifla li kellhom bejn 6 snin u inqas minn 12-il sena, u li ngħataw dożi differenti ta' Tivicay skont il-piż korporju tagħhom.
English: Supportive data from an ongoing study in children and adolescents indicated that adolescents could be given the adult dose of Tivicay.
Maltese: Data ta' sostenn minn studji li għadhom għaddejjin fi tfal u adoloxxenti tindika li l-adoloxxenti jistgħu jingħataw id-doża tal-adulti ta' Tivicay.
English: The most common side effects with Tivicay (which may affect more than 1 in 10 people) are nausea (feeling sick), diarrhoea, and headache.
Maltese: L-effetti sekondarji l-aktar komuni b'Tivicay (li jistgħu jolqtu aktar minn 1 minn kull 10) huma dardir (tħossok ma tiflaħx), dijarea, u wġigħ ta' ras.
English: Tivicay must not be given together with dofetilide, a medicine for disturbances of heart rhythm, as it may cause serious side effects.
Maltese: Tivicay m'għandux jintuża flimkien ma' dofetilide, mediċina għal disturbi fir-ritmu tal-qalb, billi jista' jikkawża effetti sekondarji serji.
English: The adult dose depends on whether the infection is known or suspected to be resistant to medicines of the class to which Tivicay belongs (integrase inhibitors).
Maltese: Id-doża tal-adulti tiddependi minn jekk ikunx magħruf jew issuspettat li l-infezzjoni hija reżistenti għal mediċini tal-klassi li minnha jagħmel parti Tivicay (inibituri tal-integrażi).
English: This is an antiviral medicine that blocks an enzyme called integrase that is needed by the HIV virus to make new copies of itself in the body.
Maltese: Din hija mediċina antivirali li timblokka enzima msejħa integrażi li hija meħtieġa mill-virus tal-HIV biex jagħmel kopji ġodda tiegħu nnifsu fil-ġisem.
English: Tivicay does not cure HIV infection or AIDS, but it may hold off damage to the immune system and the development of infections and diseases associated with AIDS.
Maltese: Tivicay ma jfejjaqx l-infezzjoni tal-HIV jew l-AIDS, iżda jista' jittardja l-ħsara prodotta lis-sistema immunitarja u l-iżvilupp ta' infezzjonijiet u mard assoċjat mal-AIDS.
English: Patients were treated with a combination of HIV medicines that included either Tivicay or raltegravir.
Maltese: Il-pazjenti ngħataw kura b'kombinazzjoni ta' mediċini kontra l-HIV li kienu jinkludu Tivicay jew raltegravir.
English: The main measure of effectiveness in all the studies was the response rate, which was the proportion of patients with a reduction of the levels of virus (viral load) in the blood to fewer than 50 copies of HIV-1 RNA per ml.
Maltese: Il-kejl ewlieni taleffikaċja fl-istudji kollha kien ir-rata ta' rispons, li kien il-proporzjon ta' pazjenti bi tnaqqis fil-livelli talvirus (tagħbija virali) fid-demm għal inqas minn 50 kopja ta' HIV-1 RNA għal kull ml.