FrancophonIA/ELRC3.0 huggingface dataset:
English: In HIV infected patients with severe immune deficiency at the time of initiation of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic infections may arise.
Maltese: Fil-pazjenti infettati b'HIV u b'immunodefiċjenza severa fil-bidu tat-trattement b'terapija kombinata mediċini antiretrovirali (CART), jista' jkun hemm reazzjoni infjammatorja għall-infezzjonijiet asintomatiċi jew għal infezzjonijiet opportunistiċi li jkun għad-fadal.
English: All of these serious ADRs occurred in one (0.1%) subject except for rash in 4 (0.6%) subjects.
Maltese: Dawn ir-reazzjonijiet avversi serji kollha seħħew f'individwu wieħed (0.1%) ħlief għal raxx li seħħ f'4 (0.6%) individwi.
English: Among 1,968 treatment-experienced patients receiving darunavir co-administered with ritonavir 600/100 mg twice daily, 236 patients were co-infected with hepatitis B or C. Co-infected patients were more likely to have baseline and treatment emergent hepatic transaminase elevations than those without chronic viral hepatitis (see section 4.4).
Maltese: Fost 1,968 pazjent li kienu ħadu kura qabel u li kienu qed jirċievu REZOLSTA flimkien ma' ritonavir 600 mg/100 mg darbtejn kuljum, 236 pazjent kienu koinfettati b'epatite B jew Ċ.
English: see section 4.5) - sildenafil - when used for the treatment of pulmonary arterial hypertension, avanafil - simvastatin, lovastatin and lomitapide (see section 4.5) - dabigatran, ticagrelor.
Maltese: Sinjali ta' osteonekrożi huma ebusija fil-ġogi, uġigħ (speċjalment tal-ġenbejn, l-irkoppa u l-ispalla) u diffikultà biex tiċċaqlaq.
English: Based on theoretical considerations REZOLSTA is expected to increase maraviroc plasma concentrations.
Maltese: Abbażi ta' konsiderazzjonijiet teoretiċi REZOLSTA hu mistenni li jgħolli l-konċentrazzjonijiet ta' maraviroc fil-plażma.
English: REZOLSTA and tenofovir disoproxil can be used without dose adjustments.
Maltese: REZOLSTA u tenofovir disoproxil jistgħu jintużaw mingħajr bidla flaġġustament tad-doża.
English: ART-naïve patients The recommended dose regimen is one film-coated tablet of REZOLSTA once daily taken with food.
Maltese: Il-livelli ta' esponiment kienu anqas minn dawk bid-doża klinikament rakkomandata fil-bnedmin.
English: As darunavir and cobicistat are highly bound to plasma proteins, it is unlikely that they will be significantly removed by haemodialysis or peritoneal dialysis (see sections 4.2 and 5.2).
Maltese: Minħabba li darunavir u cobicistat jeħlu ħafna mal-proteini fil-plażma, huwa improbabbli li dawn jitneħħew b'mod sinifikanti permezz tad-dijalisi tad-demm jew id-dijalisi tal-peritonew (ara sezzjonijiet 4.2 u 5.2).
English: REZOLSTA is not recommended for use in paediatric patients (3 to 17 years of age).
Maltese: REZOLSTA mhuwiex rrakkomandat għall-użu f'pazjenti pedjatriċi (3 snin sa 17-il sena).
English: As limited information is available on the use of REZOLSTA in patients aged 65 and over, caution should be exercised, reflecting the greater frequency of decreased hepatic function and of concomitant disease or other therapy (see sections 4.2 and 5.2).
Maltese: Minħabba li teżisti informazzjoni limitata dwar l-użu ta' REZOLSTA f'pazjenti li għandhom 65 sena jew aktar, għandu jkun hemm attenzjoni meta REZOLSTA jiġi mogħti lill-pazjenti anzjani, li tirrifletti il-frekwenza ogħla ta' funzjoni mnaqqsa tal-fwied u ta' mard konkomitanti jew terapiji oħra (ara sezzjonijiet 4.2 u 5.2).
English: Treatment-naïve darunavir/cobicistat 800/150 mg once daily + OBR N = 295
Maltese: Pazjenti li ma ħadux kura qabel b'darunavir/cobicistat 800/150 mg darba kuljum + OBR N = 295
English: The effect of severe hepatic impairment (Child-Pugh Class C) on the pharmacokinetics of cobicistat has not been studied.
Maltese: L-effett ta' indeboliment tal-fwied sever (Child-Pugh Klassi Ċ) fuq il-farmakokinetiċi ma ġiex studjat.
English: Cobicistat has been shown to decrease estimated creatinine clearance due to inhibition of tubular secretion of creatinine.
Maltese: Cobicistat intwera li jnaqqas it-tneħħija ta' kreatinina stmata minħabba l-impediment ta' tnixxija ta kreatinina.
English: reactivation of herpes simplex and herpes zoster has been observed in clinical trials with darunavir co-administered with low dose ritonavir.
Maltese: Flimkien ma dan, kienu notati r-riattivazzjoni ta' herpes simplex u herpes zoster fi provi kliniċi b'darunavir amministrat flimkien ma' doża baxxa ta' ritonavir.
English: The bioequivalence between REZOLSTA and darunavir/cobicistat 800/150 mg co-administered as single agents was established under fed and fasted conditions in healthy subjects.
Maltese: Il-bijoekwivalenza bejn REZOLSTA u darunavir/cobicistat 800/150 mg amministrati flimkien bħala sustanzi waħedhom ġie stabbilit taħt kondizzjonijiet ta' sawm u mhux ta' sawm f'individwi b'saħħithom.
English: Thyroid follicular cell adenomas were noted in male rats.
Maltese: Adenomi taċ-ċelloli follikulari tat-tirojde kienu nnutati fil-firien irġiel.
English: Uncommon osteonecrosis*
Maltese: Mhux komuni osteonekrożi*
English: Studies in rats have demonstrated that darunavir is excreted in milk and at high levels (1,000 mg/kg/day) resulted in toxicity.
Maltese: Studji fil-firien urew li darunavir jgħaddi fil-ħalib u fl-livelli għolja (1,000 mg/kg/jum) wassal għal tossiċità.
English: Relevant examples are cytomegalovirus retinitis, generalised and/or focal mycobacterial infections and pneumonia caused by Pneumocystis jirovecii (formerly known as Pneumocystis carinii).
Maltese: Irreferi għas-Sommarju tal-Karatteristiċi tal-Prodott ta' prodotti mediċinali antiretrovirali oħra għal tagħrif dwar dożaġġ.
English: Based on theoretical considerations etravirine is expected to decrease darunavir and/or cobicistat plasma concentrations.
Maltese: Abbażi ta' konsiderazzjonijiet teoretiċi etravirine hu mistenni li jnaqqas il-konċentrazzjonijiet ta' darunavir u/jew cobicistat fil-plażma.
English: At present the effect of raltegravir on darunavir plasma concentrations does not appear to be clinically relevant;
Maltese: Fil-preżent l-effett ta' raltegravir fuq il-konċentrazzjonijiet ta' darunavir fil-plażma ma jidhirx li huwa klinikament relevanti;
English: The recommended dose of maraviroc is 150 mg twice daily when co-administered with REZOLSTA.
Maltese: Id-doża rakkomandata ta' maraviroc hi ta' 150 mg darbtejn kuljum meta jingħata ma' REZOLSTA.
English: Clinical monitoring of therapeutic and adverse effects is recommended when these medicines are co-administered with REZOLSTA.
Maltese: Sorveljanza klinika tal-effetti terapewtiċi u avversi hija rrakkomandata meta dawn il-mediċini jingħataw flimkien ma' REZOLSTA.
English: Treatment-naïve darunavir/cobicistat 800/150 mg once daily N = 295
Maltese: Pazjenti li ma ħadux kura qabel b'darunavir/cobici stat 800/150 mg darba kuljum N = 295
English: Low rates of developing resistant HIV-1 virus were observed in ART-naïve patients who are treated for the first time with REZOLSTA or darunavir/ritonavir 800/100 mg once daily in combination with other ART, and in ART-experienced patients with no darunavir RAMs receiving REZOLSTA or darunavir/ritonavir 800/100 mg once daily in combination with other ART.
Maltese: Rati baxxi ta' virus ta' HIV li kien qed jiżviluppa reżistenza kienu osservati f'pazjenti li kellhomx kura b'ART qabel f'pazjenti li kienu kkurati għall-ewwel darba b'REZOLSTA jew darunavir/ritonavir 800/100 mg darba kuljum flimkien ma' ART oħrajn, u f'pazjenti b'esperjenza ta' ART li ma' ħadux darunavir RAMs li rċevew REZOLSTA jew darunavir/ritonavir 800/100 mg darba kuljum flimkien ma' ART oħrajn.
English: Non-inferiority in virologic response to the darunavir/ritonavir treatment, defined as the percentage of patients with plasma HIV-1 RNA level < 50 copies/mL, was demonstrated (at the pre-defined 12% non-inferiority margin) for both Intent-To-Treat (ITT) and On Protocol (OP) populations in the 48 week analysis.
Maltese: In-nuqqas ta' inferjorità fir-rispons viroloġiku għall-kura b'darunavir/ritonavir, iddefinit bħala l-perċentwal ta' pazjenti b'livell ta' HIV-1 RNA ta' < 50 kopja/mL fil-plażma, intwerew (fil-marġini ta' 12% ddefinit minn qabel għan-nuqqas ta' inferjorità) kemm għall-popolazzjonijiet b'Intenzjoni Li Tikkura (ITT) kif ukoll għal dawk li kienu kkurati Skont Protokoll (OP) fl-analiżi ta' 48 ġimgħa.
English: In repeated-dose toxicology studies in mice, rats and dogs, there were only limited effects of treatment with darunavir.
Maltese: Fi studji tossikoloġiċi b'doża ripetuta fil-ġrieden, il-firien u l-klieb, kien hemm biss effetti limitati tat-trattament b'darunavir.
English: REZOLSTA should not be used in treatment-experienced patients with one or more DRV-RAMs or HIV-1 RNA ≥ 100,000 copies/mL or CD4+ cell count < 100 cells x 10
Maltese: REZOLSTA m'għandux jintuża f'pazjenti esperjenzati bil-kura b'DRV-RAMs wieħed jew aktar jew b'HIV-1 RNA ≥ 100,000 kopja/mL jew għadd ta' ċelluli CD4+ < 100 x 10
English: It is not recommended to co-administer REZOLSTA with glecaprevir/pibrentasvir.
Maltese: Glecaprevir/pibrentasvir Abbażi ta' konsiderazzjonijiet teoretiċi REZOLSTA jista' jżid l-esponiment għal glecaprevir u pibrentasvir.
English: Alternative or additional contraceptive measures are recommended when oestrogen based contraceptives are co administered with REZOLSTA.
Maltese: Miżuri kontraċettivi alternattivi jew addizzjonali huma rakkomandati meta kontraċettivi bbażati fuq l-estroġenu jingħataw flimkien ma' REZOLSTA.
English: The observed hepatocellular and thyroid tumours in rodents are considered to be of limited relevance to humans.
Maltese: It-tumuri epatoċellulari u tat-tirojde li ġew osservati fl-annimali gerriema huma kkunsidrati ta' rilevanza limitata għall-bnedmin.
English: Otherwise, there were no effects on mating or fertility with darunavir treatment up to 1,000 mg/kg/day and exposure levels below (AUC-0.5 fold) of that in human at the clinically recommended dose.
Maltese: Mill-bqija, ma kienx hemm effetti fuq tgħammir u fertilità bi trattament ta' darunavir sa 1,000 mg/kg/jum u b'livelli ta' esponiment anqas minn (AUC- 0.5 drabi) dawk fil-bnedmin fid-doża klinikament rakkomandata.
English: Hepatotoxicity
Maltese: Perphenazine
English: Further information on Xultophy 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: Xultophy (insulin degludec / liraglutide)
Maltese: Xultophy (insulina degludec / liraglutide)
English: This overview was last updated in 05-2018.
Maltese: Din il-ħarsa ġenerali ġiet aġġornata l-aħħar f'05-2018.
English: Side effects on the digestive system occurred in up to 1 in 10 patients and included nausea (feeling sick), diarrhoea, vomiting, constipation, dyspepsia (indigestion), gastritis (inflammation of the stomach), abdominal pain (stomach ache), flatulence (wind), gastroesophageal reflux disease (passage of stomach acid back up towards the mouth), and distension (swelling) of the belly.
Maltese: Kien hemm effetti sekondarji fuq is-sistema diġestiva f'massimu ta' pazjent 1 minn 10 u inkludew nawżja (tħossok ma tiflaħx), dijarrea, rimettar, stitikezza, dispepsja (indiġestjoni), gastrite (infjammazzjoni tal-istonku), uġigħ addominali (uġigħ fl-istonku), gass fl-istonku (gass), mard ta' rifluss gastroesofagali (il-passaġġ ta' aċidu tal-istonku lura lejn il-ħalq) u distensjoni (nefħa) taż-żaqq.
English: Other information about Xultophy
Maltese: Informazzjoni oħra dwar Xultophy
English: Xultophy received a marketing authorisation valid throughout the EU on 18 September 2014.
Maltese: Xultophy ingħata awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fit-18 ta' Settembru 2014.
English: The other active substance in Xultophy, liraglutide, belongs to the class of diabetes medicines known as GLP-1 agonists.
Maltese: Is-sustanza attiva l-oħra fi Xultophy, il-liraglutide, tappartjeni għall-klassi ta' mediċini tad-dijabete magħrufa bħala agonisti GLP-1.
English: In the group that kept on receiving the GLP-1 agonist, it fell from 7.7% to 7.4%.
Maltese: Fil-grupp li baqa' jieħu l-agonista GLP-1, il-livell medju niżel minn 7.7% għal 7.4%.
English: The average HbA1c level, which was 8.3% at the start, fell to 6.4% after 26 weeks of treatment with Xultophy, compared with 6.9% and 7.0% respectively with insulin degludec and liraglutide.
Maltese: Il-livell medju ta' HbA1c, li fil-bidu kien 8.3%, niżel għal 6.4% wara 26 ġimgħa ta' kura bi Xultophy, meta mqabbel ma' 6.9% u 7.0% rispettivament blinsulina degludec u liraglutide.
English: The active substances in Xultophy are insulin degludec and liraglutide.
Maltese: Is-sustanzi attivi fi Xultophy huma l-insulina degludec u liraglutide.
English: Why is Xultophy approved?
Maltese: Għaliex ġie approvat Xultophy?
English: • The first study involved 1,663 patients whose diabetes was not adequately controlled with the diabetes medicines metformin or metformin and pioglitazone taken by mouth.
Maltese: • L-ewwel studju involva 1,663 pazjent li d-dijabete tagħhom ma kinitx ikkontrollata b'mod xieraq bil-mediċini tad-dijabete metformina jew metformina u pijoglitazon li jittieħdu mill-ħalq.
English: In the group using insulin degludec it fell from 8.8% to 8.0%.
Maltese: Fil-grupp li juża l-insulina degludec il-livell medju niżel minn 8.8% għal
English: What are the risks associated with Xultophy?
Maltese: X'inhuma r-riskji assoċjati ma' Xultophy?
English: • The third study involved 438 patients whose blood glucose was not adequately controlled by a combination of a GLP-1 agonist (liraglutide or exenatide) and metformin with or without other diabetes medicines taken by mouth.
Maltese: • It-tieni studju involva 438 pazjent li l-glukożju fid-demm tagħhom ma kienx ikkontrollat b'mod xieraq b'kombinazzjoni tal-agonista GLP-1 (liraglutide jew exenatide) u l-metformina ma' mediċini għad-dijabete oħra li jittieħdu mill-ħalq jew mingħajrhom.
English: As for all medicines, data on the use of Xultophy are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Xultophy hija ssorveljata kontinwament.
English: Xultophy is given once a day, preferably at the same time each day.
Maltese: Xultophy jingħata darba kuljum, preferibbilment fl-istess ħin kuljum.
English: The majority of patients treated with Xultophy in these studies achieved control of their blood glucose (HbA1c below 7.0%) and many achieved HbA1c below 6.5%.
Maltese: Il-maġġoranza tal-pazjenti kkurati bi Xultophy f'dawn l-istudji kisbu kontroll tal-glukożju fid-demm tagħhom (HbA1c taħt is-7%) u ħafna kisbu HbA1c taħt is-6.5%.
English: Insulin degludec is slightly different from human insulin as it is absorbed more slowly and regularly by the body after an injection and it works for a long time.
Maltese: L-insulina degludec hi ftit differenti mill-insulina umana billi tiġi assorbita iktar bil-mod u b'mod regolari mill-ġisem wara injezzjoni u taħdem għal żmien twil.
English: The site of injection should be changed with each injection to avoid changes to the skin (such as thickening) that can make the medicine work less well than expected.
Maltese: Issit tal-injezzjoni għandu jinbidel ma' kull injezzjoni biex jiġu evitati bidliet fil-ġilda (bħal tħaxxin) li jista' jġiegħel lill-mediċina taħdem inqas tajjeb milli mistenni.
English: Once-daily injection of Xultophy has been shown to be of benefit in controlling blood glucose in three main studies involving 2,514 patients with type 2 diabetes.
Maltese: L-injezzjoni bi Xultophy darba kuljum uriet li hi ta' benefiċċju fil-kontroll tal-glukożju fid-demm fi tliet studji ewlenin li involvew 2,514-il pazjent bid-dijabete tat-tip 2.
English: For the full list of side effects and restrictions with Xultophy, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet bi Xultophy, ara l-fuljett ta' tagħrif.
English: Treatment with Xultophy and metformin was compared with treatment using insulin degludec and metformin.
Maltese: Il-kura bi Xultophy u metformina tqabblet ma' kura bl-użu ta' insulina degludec u metformina.
English: Average HbA1c at the start was 8.7% in the Xultophy group, and fell after 26 weeks of treatment to 6.9%.
Maltese: Fil-grupp ta' Xultophy, il-livell medju ta' HbA1c fil-bidu kien 8.7%, u niżel għal 6.9% wara 26 ġimgħa ta' kura.
English: The most common side effect with Xultophy (which may affect more than 1 in 10 people) is hypoglycaemia (low blood glucose).
Maltese: L-effett sekondarju l-aktar komuni bi Xultophy (li jista' jaffettwa aktar minn persuna 1 minn kull 10) hu ipogliċemija (glukożju baxx fid-demm).
English: One of the active substances in Xultophy, insulin degludec, is a replacement insulin that acts in the same way as naturally produced insulin and helps glucose enter cells from the blood.
Maltese: Waħda mis-sustanzi attivi ta' Xultophy, l-insulina degludec, hija insulina ta' sostituzzjoni li taġixxi bl-istess mod bħallinsulina prodotta b'mod naturali u tgħin biex il-glukożju jidħol fiċ-ċelloli mid-demm.
English: Average HbA1c was 7.8% before patients started to receive Xultophy, and fell after 26 weeks of treatment to 6.4%.
Maltese: Il-livell medju ta' HbA1c kien 7.8% qabel ma l-pazjenti bdew jingħataw Xultophy, u niżel wara 26 ġimgħa ta' kura għal 6.4%.
English: The company that markets Xultophy will provide educational materials for healthcare professionals, explaining how to use the medicine safely, so as to reduce the risk of medication errors.
Maltese: Il-kumpanija li tqiegħed Xultophy fis-suq se tipprovdi materjali edukattivi għall-professjonisti fil-qasam tal-kura tas-saħħa, biex tispjega kif il-mediċina tintuża b'mod sigur, biex jonqos ir-riskju ta' żbalji li jittieħdu bil-mediċina.
English: What measures are being taken to ensure the safe and effective use of Xultophy?
Maltese: X'miżuri qed jittieħdu biex jiġi żgurat l-użu sigur u effettiv ta' Xultophy?
English: How is Xultophy used?
Maltese: Kif jaħdem Xultophy?
English: Adding this medicine to other diabetes medicines offers better control of blood glucose and having an alternative treatment option is valuable in individualising treatment.
Maltese: Iż-żieda ta' din il-mediċina ma' mediċini oħra tad-dijabete toffri kontroll aħjar ta' glukożju fid-demm u huwa importanti li jkollok għażla ta' kura alternattiva flindividwalizzazzjoni tal-kura.
English: EMA/90006/2015 EMEA/H/C/001104
Maltese: EMEA/H/C/001104
English: The full EPAR for Prevenar 13 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: Prevenar 13 contains the polysaccharides from 13 different types of S. pneumoniae (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F).
Maltese: Prevenar 13 fih il-polisakkaridi minn 13-il tip differenti ta' S. pneumoniae (serotipi 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F u 23F).
English: pneumococcal polysaccharide conjugate vaccine (13-valent, adsorbed)
Maltese: Sommarju tal-EPAR għall-pubbliku vaċċin pnewmokokkiku polisakkaridiku konjugat (13-il valent, assorbit)
English: This is a summary of the European public assessment report (EPAR) for Prevenar 13.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Prevenar 13.
English: The first study involved 835 adults aged 50 to 64 years who had not previously been vaccinated against invasive disease caused by S. pneumoniae.
Maltese: L-ewwel studju involva 835 adult ta' bejn 50 u 64 sena li qatt ma kienu tlaqqmu qabel kontra mard invażiv ikkawżat minn S. pneumoniae.
English: It is available as a suspension for injection that contains parts from 13 different types of the bacterium Streptococcus pneumoniae (S. pneumoniae).
Maltese: Huwa disponibbli bħala sospensjoni għall-injezzjoni li fiha partijiet minn 13-il tip differenti tal-batterju Streptococcus pneumoniae (S. pneumoniae).
English: In adults and the elderly, the most common side effects (seen in more than 1 patient in 10) are decreased appetite, headaches, diarrhoea, fever (only very common in adults aged 18 to 29 years), vomiting (only very common in adults aged 18 to 49 years), rash, reactions at the site of injection, limitation of arm movement, arthralgia and myalgia (joint and muscle pain), chills and fatigue.
Maltese: Fl-adulti u l-anzjani, l-aktar effetti sekondarji komuni (li dehru f'aktar minn pazjent 1 minn kull 10) huma n-nuqqas ta' aptit, uġigħ ta' ras, dijarrea, deni (komuni ħafna biss fl-adulti ta' bejn it-18-il sena u d-29 sena), remettar (komuni ħafna biss fl-adulti ta' bejn it-18-il sena u d-49 sena), raxx, reazzjonijiet fis-sit tal-injezzjoni, limitazzjoni taċ-ċaqliq tad-driegħ, artalġja u mijalġja (uġigħ fil-ġogi u fil-muskoli), tertir u għeja Għal-lista sħiħa tal-effetti sekondarji kollha rrapportati bl-użu ta' Prevenar 13, ara l-fuljett ta' tagħrif.
English: In children, the ability of Prevenar 13 to trigger the production of antibodies (immunogenicity) was assessed in two main studies involving 1,266 healthy children who were vaccinated between the ages of two and 15 months and in a third study involving 598 children aged between five and 17 years old who had previously been vaccinated with Prevenar or who had never been vaccinated for invasive pneumococcal disease.
Maltese: Fit-tfal, l-abbiltà ta' Prevenar 13 li jqanqal il-produzzjoni ta' antikorpi (immunoġeniċità) ġiet evalwata f'żewġ studji ewlenin li involvew 1,266 tifel u tifla b'saħħithom li tlaqqmu bejn l-età ta' xahrejn u 15-il xahar u fit-tielet studju li nvolva 598 tifel u tifla bejn l-etajiet ta' ħamsa u 17-il sena li qabel kienu tlaqqmu bi Prevenar jew li qatt ma kienu tlaqqmu għal mard pnewmokokkiku invażiv.
English: Prevenar 13 is used to protect children aged between six weeks and 17 years against invasive disease, pneumonia (infection of the lungs) and acute otitis media (infection of the middle ear) caused by S. pneumoniae.
Maltese: Prevenar 13 jintuża biex jipproteġi lit-tfal ta' bejn sitt ġimgħat u 17-il sena kontra mard invażiv, pulmonite (infezzoni fil-pulmun) u otite media akuta (infezzjoni fil-widna minn ġewwa) kkawżati minn S. pneumoniae.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Prevenar 13 on 9 December 2009.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Prevenar 13 fid-9 ta' Diċembru 2009.
English: Other information about Prevenar 13
Maltese: Informazzjoni oħra dwar Prevenar 13
English: In both studies, Prevenar 13 was compared with a similar vaccine containing the polysaccharides from 23 different types of S. pneumoniae (23-valent polysaccharide vaccine).
Maltese: Fiż-żewġ studji, Prevenar 13 tqabbel ma' vaċċin simili li fih il-polisakkaridi minn 23 tip differenti ta' S. pneunoniae (vaċċin 23-valent polisakkaridiku).
English: Prevenar 13 is very similar to Prevenar but contains six additional polysaccharides from serotypes which are responsible for between 16 and 60% of the cases.
Maltese: Prevenar 13 huma simili ħafna għal Prevenar iżda fih sitt polisakkaridi addizzjonali minn serotipi li huma responsabbli għal bejn 16 u 60% tal-każijiet.
English: Prevenar 13 is a vaccine.
Maltese: Prevenar 13 huwa vaċċin.
English: A fourth study involved approximately 85,000 adults over 65 year of age who had not previously been vaccinated with the 23-valent polysaccharide vaccine, and compared Prevenar 13 with placebo (a dummy treatment).
Maltese: Ir-raba' studju involva bejn wieħed u ieħor 85,000 adult ta' aktar minn 65 sena li qatt ma kienu tlaqqmu qabel bil-vaċċin 23-valent polisakkaridiku, u qabbel Prevenar 13 ma' plaċebo (kura finta).
English: Prevenar 13 contains small amounts of polysaccharides (a type of sugar) extracted from the ‘capsule' that surrounds the S. pneumoniae bacterium.
Maltese: Prevenar 13 fih ammonti żgħar ta' polisakkaridi (tip ta' zokkor) estratti mill-“kapsula” li tiċċirkonda lbatterju S. pneumonia.