FrancophonIA/ELRC3.0 huggingface dataset:
English: Infliximab treatment reduced the rate of progression of peripheral joint damage compared with placebo treatment at the week 24 primary endpoint as measured by change from baseline in total modified vdH-S score (mean ± SD score was 0.82 ± 2.62 in the placebo group compared with -0.70 ± 2.53 in the infliximab group; p < 0.001).
Maltese: Il-kura b'infliximab naqqset r-rata tal-avvanz tal-ħsara periferali fil-ġogi meta mqabbla mal-kura bi plaċebo fil-punt aħħari primarju ta' ġimgħa 24 hekk kif imkejla mill-bidla mill-linja bażi fil-punteġġ totali modifikat ta' vdH-S (medja ± punteġġ SD kien 0.
English: a p < 0.001, for each infliximab treatment group vs. control.
Maltese: Ġimgħa 50 a p < 0.001, għal kull grupp ta' kura b'infliximab vs il-kontroll.
English: Zessly may be stored at temperatures up to a maximum of 30°C for a single period of up to 6 months, but not exceeding the original expiry date.
Maltese: Zessly jista' jinħażen f'temperaturi sa massimu ta' 30°C għal perjodu wieħed sa 6 xhur, iżda li ma jaqbiżx id-data ta' skadenza oriġinali.
English: PATIENT REMINDER CARD
Maltese: DATA TA' REVIŻJONI TAT-TEST
English: Anaphylactic reaction, lupus-like syndrome, serum sickness or serum sickness-like reaction.
Maltese: Mhux komuni: Reazzjoni anafilattika, sindrome bħal tal-lupus, marda tas-serum jew reazzjoni bħal marda tas-serum.
English: At 38 weeks, 9 of 101 patients treated with infliximab (2 at 5 mg/kg and 7 at 10 mg/kg) died compared to one death among the 49 patients on placebo.
Maltese: 9 minn 101 pazjent li ngħataw infliximab (2 b'5 mg/kg u 7 b'10 mg/kg) mietu meta mqabbel ma'
English: A clinical study in patients with moderate to severe psoriasis was designed to assess the efficacy and safety of long-term maintenance therapy versus re-treatment with an induction regimen of infliximab (maximum of four infusions at 0, 2, 6, and 14 weeks) following disease flare.
Maltese: Studju kliniku f'pazjenti bi psorjasi moderata sa severa kien maħsub biex tiġi evalwata l-effikaċja u s-sigurtà ta' terapija fit-tul kontra kura mill-ġdid b'kors ta' induzzjoni ta' infliximab (massimu ta' erba' infuzjonijiet f'ġimgħat 0, 2 6 u 14) wara li tkun ħraxet il-marda.
English: Adequate data of treating patients who are carriers of HBV with antiviral therapy in conjunction with TNF-antagonist therapy to prevent HBV reactivation are not available.
Maltese: M'hemmx dejta adegwata dwar il-kura ta' pazjenti li jġorru HBV b'terapija antivirali flimkien ma' antagonist-TNF sabiex tiġi evitata l-attivazzjoni mill-ġdid tal-HBV.
English: Date of Zessly therapy initiation:
Maltese: Zessly biex:
English: Peripheral blood mononuclear cells (PBMC) from infliximab-treated patients showed undiminished proliferative responsiveness to stimuli compared with untreated patients, and no substantial changes in cytokine production by stimulated PBMC were observed following treatment with infliximab.
Maltese: Ċelluli mononukleari periferiċi tad-demm (PBMC) meħuda minn pazjenti li ngħataw infliximab ma wrew l-ebda tnaqqis fir-rispons proliferattiv għal stimuli meta mqabbla ma' pazjenti mhux fuq kura, u ma kinux osservati bidliet sostanzjali fil-produzzjoni ta'
English: Adults (≥ 18 years)
Maltese: Adulti (≥ 18-il sena) Artrite rewmatojde
English: • These infections may be serious and include tuberculosis, infections caused by viruses, fungi, bacteria or other organisms in the environment and sepsis that may be life-threatening.
Maltese: • Dawn l-infezzjonijiet jistgħu jkunu serji u jinkludu tuberkulożi, infezzjonijiet ikkawżati minn viruses, fungi, batterji, jew organiżmi oħra fl-ambjent u sepsi li tista' tkun ta' periklu għallħajja.
English: Malignancies and lymphoproliferative disorders Malignancies, some fatal, have been reported among children, adolescents and young adults (up to
Maltese: Tumuri malinni, xi wħud fatali, kienu rrappurtati fost tfal, adolexxenti u adulti żgħażagħ (sa 22 sena)
English: In infants exposed in utero to infliximab, fatal outcome due to disseminated Bacillus CalmetteGuérin (BCG) infection has been reported following administration of BCG vaccine after birth.
Maltese: Fi trabi esposti in utero għal infliximab, kien irrappurtat riżultat fatali minħabba infezzjoni mifruxa kkawżata minn Bacillus Calmette Guérin (BCG) wara l-għoti tat-tilqima ta' BCG wara t-twelid.
English: Table 6 Percent of patients with Crohn's disease achieving corticosteroid-free clinical remission at week 26
Maltese: Tabella 6 Perċentwali ta' pazjenti bil-marda ta' Crohn li kisbu nuqqas totali tas-sinjali u s-sintomi kliniċi mingħajr kortikosterojdi f'ġimgħa 26
English: Week 30
Maltese: Ġimgħa 30
English: Induction treatment in fistulising active Crohn's disease
Maltese: Tumuri malinni u disturbi proliferattivi tas-sistema limfatika
English: Others
Maltese: ċ
English: Zessly 100 mg powder for concentrate for solution for infusion.
Maltese: Zessly 100 mg trab għal konċentrat għal soluzzjoni għall-infużjoni.
English: Patients with no deterioration/patients evaluated (%)c
Maltese: Pazjenti li ma marrux għallagħar/pazjenti evalwati (%)ċ
English: Currently available pharmacokinetic data are described in section 5.2 but no recommendation on a posology can be made in children younger than 6 years.
Maltese: Dejta farmakokinetika disponibbli hi deskritta fis-sezzjoni 5.2 imma l-ebda rakkomandazzjoni dwar il-pożoloġija ma tista' tingħata fi tfal li għandhom inqas minn 6 snin.
English: Zessly is indicated for treatment of severe, active Crohn's disease, in children and adolescents aged 6 to 17 years, who have not responded to conventional therapy including a corticosteroid, an immunomodulator and primary nutrition therapy; or who are intolerant to or have contraindications for such therapies.
Maltese: 17-il sena, li ma kellhomx rispons għat-terapija konvenzjonali inklużi kortikosterojd, immunomodulatur u terapija ta' nutrizzjoni primarja, jew li huma intolleranti jew għandhom kontra-indikazzjonijiet għal dawn it-tipi ta' terapiji.
English: Gastrointestinal haemorrhage, diarrhoea, dyspepsia, gastroesophageal reflux, constipation.
Maltese: Komuni ħafna: Uġigħ fl-addome, nawseja Komuni: Emorraġija gastrointestinali, dijarea, dispepsja, rifluss gastroesofagali, stitikezza.
English: The safety and efficacy of infliximab in children and adolescents younger than 18 years for the indications of juvenile idiopathic arthritis, psoriatic arthritis and ankylosing spondylitis have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' infliximab fit-tfal u adoloxxenti iżgħar minn 18-il sena għall-indikazzjoni tal-artrite idjopatka ġuvenili, artrite psorijatika u ankylosing spondylitis ma ġewx determinati s'issa.
English: Antibodies to infliximab cannot always be detected in serum samples.
Maltese: infliximab fis-serum u l-antikorpi kontra infliximab.
English: In a 6-month repeated dose toxicity study in mice, using the same analogous antibody against mouse TNFα, crystalline deposits were observed on the lens capsule of some of the treated male mice.
Maltese: Fi studju li dam 6 xhur dwar tossiċità b'dożi ripetuti li sar fil-ġrieden, fejn intuża l-istess antikorp analogu kontra TNFα tal-ġrieden, depożiti kristallini kienu osservati fuq il-kapsula tal-lenti ta' wħud mil-ġrieden irġiel ikkurati.
English: Ankylosing spondylitis Psoriatic arthritis Plaque psoriasis
Maltese: Ankylosing spondylitis (Marda ta' Bechterew) Ankylosing spondylitis hija marda infjammatorja tax-xewka tad-dahar.
English: The number of ulcerative colitis-related hospitalisations was significantly lower in the 5 and 10 mg/kg infliximab treatment groups than in the placebo group (mean number of hospitalisations per 100 subject-years: 21 and 19 vs. 40 in the placebo group; p = 0.019 and p = 0.007, respectively).
Maltese: In-numru ta' dawk li kellhom imorru l-isptar minħabba kolite ulċerattiva kien aktar baxx b'mod sinifikanti fil-gruppi ta' kura b'5 u 10 mg/kg infliximab milli fil-grupp tal-plaċebo (il-medja tan-numru ta' dawk li marru l-isptar għal kull 100 sena ta' individwu: 21 u 19 kontra 40 fil-grupp tal-plaċebo; p = 0.
English: In clinical studies with infliximab in which 5,780 patients were treated, representing 5,494 patient years, 5 cases of lymphomas and 26 non-lymphoma malignancies were detected as compared with no lymphomas and 1 non-lymphoma malignancy in 1,600 placebo-treated patients representing 941 patient years.
Maltese: pazjenti, 5 każijiet ta' limfomi u 26 tumuri malinni mhux limfomi instabu meta mqabbla mal-ebda każ ta' limfoma u każ wieħed ta' tumur malinn mhux limfoma f'1,600 pazjent ikkurati bi plaċebo li jirrapreżentaw 941 sena ta' pazjenti.
English: Infliximab has been studied only in combination with conventional immunosuppressive therapy.
Maltese: kortikosterojdi u immunosoppressivi,
English: AZA Monotherapy infliximab Monotherapy infliximab + AZA Combination Therapy
Maltese: Kura mħallta b'infliximab + AZA
English: For patients receiving corticosteroids at baseline, the proportion of patients in remission and not receiving corticosteroids at week 54 was 38.5% (5/13) for the q8 week and 0% (0/13) for the q12 week maintenance treatment group.
Maltese: fil-grupp ta' kura ta' manteniment ta' q8 ġimgħat u 0% (0/13) fil-grupp ta' kura ta' manteniment ta'
English: Infections were reported more frequently for subjects who received q8 week as opposed to q12 week infusions (73.6% and 38.0%, respectively), while serious infections were reported for 3 subjects in the q8 week and 4 subjects in the q12 week maintenance treatment group.
Maltese: Infezzjonijiet kienu rrappurtati b'mod aktar frekwenti għal individwi li rċevew ġimgħa q8 għall-kuntrarju ta' ġimgħa q12 (73.6% u 38.0%, rispettivament),
English: Thrombocytopenia, lymphopenia, lymphocytosis.
Maltese: IL-PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN.
English: • Your doctor should test you for hepatitis B virus.
Maltese: B jew jekk taf jew tissuspetta li inti qed iġġorr il-virus tal-epatite B.
English: Patients with moderate or severe heart failure (NYHA class III/IV) (see sections 4.4 and 4.8).
Maltese: Kienu rrappurtati wkoll każijiet ta' agranuloċitosi (ara sezzjoni 4.8).
English: In the infliximab group, the mean change in total modified vdH-S score remained below 0 at the week 54 timepoint.
Maltese: il-medja tal-bidla fil-punteġġ totali modifikat ta' vdH-S baqa' taħt 0 sat-timepoint ta' ġimgħa 54.
English: The number of ulcerative colitis-related surgical procedures was also lower in the 5 and 10 mg/kg infliximab treatment groups than in the placebo group (mean number of surgical procedures per 100 subject-years: 22 and 19 vs. 34; p = 0.145 and p = 0.022, respectively).
Maltese: In-numru ta' operazzjonijiet kiruġiċi relatati mal-kolite ulċerattiva kien ukoll aktar baxx fil-gruppi ikkurati b'5 u 10 mg/kg infliximab milli fil-grupp tal-plaċebo (il-medja tan-numru ta' dawk li kellhom operazzjonijiet kirurġiċi għal kull 100 sena ta' individwu: 22 u
English: At 102 weeks there were 80 subjects still on infliximab treatment and among those, 71 (89%) were ASAS 20 responders.
Maltese: F'ġimgħa 102 kien hemm 80 individwu li kienu għadhom fuq il-kura b'infliximab u fost dawk, 71 (89%) irrispondew għal ASAS 20.
English: Concurrent administration of TNF-alpha inhibitor and anakinra
Maltese: • Tbati jew tweġġa biex tieħu n-nifs, uġigħ fis-sider
English: Limited experience from re-treatment with one single infliximab dose in psoriasis after an interval of 20 weeks suggests reduced efficacy and a higher incidence of mild to moderate infusion reactions when compared to the initial induction regimen (see section 5.1).
Maltese: Esperjenza limitata bl-għoti mill-ġdid ta' doża waħda ta' infliximab għal psorjasi wara intervall ta' 20 ġimgħa jindika tnaqqis fl-effikaċja u inċidenza ogħla ta' reazzjonijiet għall-infużjoni minn ħfief sa moderati meta mqabbla mal-kors tal-bidu tal-induzzjoni (ara sezzjoni 5.1).
English: Structural joint damage (erosions and joint space narrowing) in both hands and feet was measured by the change from baseline in the total van der Heijde-modified Sharp score (0-440).
Maltese: Ħsara strutturali fil-ġogi (tmermir u tidjiq fl-ispazju tal-ġogi) kemm fl-idejn kif ukoll fis-saqajn tkejlet permezz tal-bidla mil linja bażi fil-punteġġ totali ta' modifikat ta' van der Heijde Sharp (0-440).
English: Median
Maltese: Investigazzjonijiet
English: Experimental data show that TNFα is essential for the clearing of intracellular infections.
Maltese: Tagħrif sperimentali juri li TNFα huwa essenzjali biex jitneħħew infezzjonijiet intraċellulari.
English: Placebo Maintenance (n = 110)
Maltese: (n = 110)
English: The efficacy was assessed in a randomised, double-blinded, placebo-controlled study in 94 patients with fistulising Crohn's disease who had fistulas that were of at least 3 months' duration.
Maltese: L-effikaċja kien ukoll studjat fi studju li ntgħażlu b'mod każwali, double-blinded, ikkontrollat bi plaċebo f'94 pazjent bil-marda ta' Crohn fistulizzanti li kellhom fistuli li kienu ilhom mill-inqas 3 xhur.
English: • Some patients who have received TNF-blockers, including infliximab, have developed a rare type of cancer called hepatosplenic T-cell lymphoma.
Maltese: • Xi pazjenti li rċevew imblokkaturi ta' TNF, inkluż infliximab, żviluppaw tip ta' kanċer rari li jissejjaħ limfoma taċ-ċellula-T epatosplenika.
English: Appropriate empiric antifungal therapy should be considered while a diagnostic workup is being performed taking into account both the risk for severe fungal infection and the risks of antifungal therapy.
Maltese: Terapija empirika xierqa kontra l-fungu għandha tiġi kkunsidrata filwaqt li pjan dijanjostiku jkun qed jitwettaq billi jiġi kkunsidrat kemm ir-riskju għal infezzjoni qawwija fungali kif ukoll r-riskji tat-terapija kontra l-fungu.
English: Infliximab with or without AZA was assessed in a randomised, double-blind, active comparator study of 508 adult patients with moderate to severe Crohn's disease (CDAI ≥ 220 ≤ 450) who were naive to biologics and immunosuppressants and had a median disease duration of 2.3 years.
Maltese: Infliximab b'AZA jew mingħajru kien evalwat fi studju komparatur b'mod attiv, li fih il-parteċipanti ntgħażlu b'mod każwali, double-blind ta' 508 pazjenti adulti b'marda ta' Crohn minn moderata sa severa (CDAI ≥ 220 ≤ 450) li qatt ma kienu ħadu sustanzi bijoloġiċi u immunosoppressanti u li kellhom il-marda għal tul ta' żmien medjan ta' 2.3 snin.
English: Complement factor abnormal.
Maltese: Fattur tal-komplement mhux normali.
English: Fistulising, active Crohn's disease
Maltese: Kura ta' induzzjoni għal marda ta' Crohn fistulizzanti attiva
English: Analysis of lamina propria mononuclear cells obtained by biopsy of the intestinal mucosa showed that infliximab treatment caused a reduction in the number of cells capable of expressing TNFα and interferonγ.
Maltese: Analiżi ta' ċelluli mononukleari tal-lamina propria miksuba permezz ta' bijopsija tal-mukuża tal-musrana wriet li kura b'infliximab ikkawżat tnaqqis fin-numru ta' ċelluli li kienu kapaċi jesprimu TNFα u interferon γ.
English: The co-primary endpoints were the proportion of patients in clinical remission (CDAI < 150) at week 30 and time to loss of response through week 54.
Maltese: Il-ko-punti aħħarin ewlenin kienu l-proporzjon ta' pazjenti fit-tnaqqis kliniku (CDAI < 150)
English: In the first study, (study 8), which had a 3 month double-blind phase, 70 patients received either 5 mg/kg infliximab or placebo at weeks 0, 2, 6 (35 patients in each group).
Maltese: Fl-ewwel studju (studju 8), li kellu fażi ta 3 xhur double-blind, 70 pazjent irċevew jew 5 mg/kg infliximab jew plaċebo f'ġimgħat 0, 2, 6 (35 pazjent f'kull grupp).
English: In an exploratory clinical study evaluating the use of infliximab in patients with moderate to severe chronic obstructive pulmonary disease (COPD), more malignancies were reported in infliximabtreated patients compared with control patients.
Maltese: Fi studju kliniku ta' stħarriġ li evalwa l-użu ta' infliximab f'pazjenti b'mard ostruttiv kroniku tal-pulmun (COPD) minn moderat sa sever, kien hemm aktar tumuri rrappurtati bil-pazjenti kkurati b'infliximab meta mqabbla ma' pazjenti tal-kontroll.
English: Zalviso is a ‘hybrid medicine'.
Maltese: Zalviso huwa ‘mediċina ibrida'.
English: The full EPAR and risk management plan summary for Zalviso 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 contains the active substance sufentanil.
Maltese: Fih is-sustanza attiva sufentanil.
English: For abdominal surgery, the average decrease in pain intensity was 50 points greater with Zalviso than with placebo (106 versus 56).
Maltese: Għal operazzjoni addominali, it-tnaqqis medju flintenistà tal-uġigħ kien 50 punti iktar b'Zalviso milli bi plaċebo (106 kontra 56).
English: Zalviso is available as sublingual tablets containing 15 micrograms of sufentanil.
Maltese: Zalviso huwa disponibbli bħala pilloli għal taħt l-ilsien li fihom 15-il mikrogramma ta' sufentanil.
English: Of 177 patients using Zalviso, 139 rated their pain control as excellent or good (79%), compared with 118 of 180 (66%) using morphine.
Maltese: Minn 177 pazjent li użaw Zalviso, 139 ikklassifikaw il-kontroll tal-uġigħ tagħhom bħala eċċellenti jew tajjeb (79%), meta mqabbel ma' 118 minn 180 (66%) li użaw il-morfina.
English: This is a summary of the European public assessment report (EPAR) for Zalviso.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Zalviso.
English: Why is Zalviso approved?
Maltese: Għaliex ġie approvat Zalviso?
English: The active substance in Zalviso, sufentanil, is an opioid.
Maltese: Is-sustanza attiva f'Zalviso, sufentanil, hija opjojde.
English: For knee and hip surgery the decrease in pain intensity was around 88 points greater with Zalviso (76 versus -11) than with placebo.
Maltese: Għal operazzjoni flirkoppa u fil-ġenbejn, it-tnaqqis fl-intensità tal-uġigħ kien madwar 88 punti iktar b'Zalviso (76 kontra11) milli bi plaċebo.
English: This means that it is similar to a ‘reference medicine' containing the same active substance, but Zalviso is available in a different form.
Maltese: Dan ifisser li huwa simili għal ‘mediċina ta' referenza' li fiha l-istess sustanza attiva, iżda Zalviso huwa disponibbli f'forma differenti.
English: A third main study compared Zalviso with a patient-controlled pain relief system using morphine, another opioid, and involved 359 patients who had undergone major abdominal, knee or hip surgery.
Maltese: It-tielet studju ewlieni qabbel Zalviso ma' sistema ta' serħan mill-uġigħ ikkontrollata permezz talmorfina, opjojde ieħor, u li involva 359 pazjent li għaddew minn operazzjoni addominali kbira, talirkoppa jew tal-ġenbejn.
English: The most serious side effect is respiratory depression (impaired breathing) which could potentially lead to the patient stopping breathing altogether.
Maltese: L-iktar effetti sekondarji serji kienu depressjoni respiratorja (indeboliment sinifikanti fit-teħid tan-nifs) li jista' potenzjalment iwassal biex il-pazjent jieqaf jieħu n-nifs kompletament.
English: Other information about Zalviso
Maltese: Informazzjoni oħra dwar Zalviso
English: One main study involved 178 patients who had abdominal surgery (surgery on the belly) and another involved 426 patients who had surgery on the knee or hip.
Maltese: Studju wieħed ewlieni involva 178 pazjent li kellhom operazzjoni addominali (operazzjoni fiż-żaqq) u ieħor li involva 426 pazjent li kellhom operazzjoni fl-irkoppa jew fil-ġenbejn.
English: The reference medicine for Zalviso is called Sufenta Forte, and is available as a solution for injection, whereas Zalviso is available as sublingual tablets (tablets to be dissolved under the tongue).
Maltese: Il-mediċina ta' referenza għal Zalviso jisimha Sufenta Forte, u hija disponibbli bħala soluzzjoni għal injezzjoni, filwaqt li Zalviso huwa disponibbli bħala pilloli għal taħt l-ilsien (pilloli biex jinħallu taħt l-ilsien).
English: The device locks for 20 minutes after the patient has taken a tablet and does not allow the patient to take more than 3 doses in one hour.
Maltese: Lapparat jissakkar għal 20 minuta wara li l-pazjent ikun ħa pillola u ma jippermettix li l-pazjent jieħu iktar minn 3 dożi f'siegħa.
English: For the full list of side effects and restrictions with Zalviso, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u restrizzjonijiet kollha b'Zalviso, ara l-fuljett ta' tagħrif.
English: Because Zalviso is a hybrid generic, the applicant presented data on the reference medicine in addition to results from its own studies.
Maltese: Minħabba li Zalviso huwa ġeneriku ibridu, l-applikant ippreżenta dejta dwar il-mediċini ta' referenza flimkien ma' riżultati mill-istudji tiegħu stess.
English: What are the risks associated with Zalviso?
Maltese: X'inhuma r-riskji assoċjati ma' Zalviso?
English: In both cases Zalviso was compared with placebo (a dummy treatment).
Maltese: Zalviso tqabbel ma' plaċebo (kura finta).
English: Regarding safety, the side effects were those expected of opioids, and were considered manageable.
Maltese: Fir-rigward tas-sigurtà, l-effetti sekondarji kienu dawk mistennija minn opjojdi, u kienu kkunsidrati ġestibbli.
English: Zalviso is an opioid (a strong painkiller) that is used to treat pain occurring in adults after an operation.
Maltese: Zalviso huwa opjojde (mediċina qawwija kontra l-uġigħ) li jintuża biex jikkura uġigħ li jseħħ f'adulti wara operazzjoni.
English: However, considering the fact that post-operative pain improves by itself over time as well as the potential for addiction or the body becoming used to the opioid and requiring larger doses, the medicine and its administration device should only be used in a hospital setting, and restricted to use for a maximum duration of 72 hours.
Maltese: Madankollu, b'kunsiderazzjoni tal-fatt li l-uġigħ wara operazzjoni jonqos waħdu maż-żmien kif ukoll il-potenzjal ta' dipendenza jew li l-ġisem jidra l-opjojde u jkun jeħtieġ dożi akbar, il-mediċina u l-apparat ta' għoti tagħha għandhom jintużaw biss fi sptar, u jkunu limitati għal użu ta' perjodu massimu ta' 72 siegħa.
English: How does Zalviso work?
Maltese: Kif jaħdem Zalviso?
English: A risk management plan has been developed to ensure that Zalviso is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Zalviso jintuża bl-aktar mod sigur possibbli.
English: The main measure of effectiveness was based on a patient score that measured the decrease in intensity of pain over 48 hours of treatment.
Maltese: Il-kejl ewlieni tal-effikaċja kien abbażi ta' punteġġ tal-pazjenti li kejjel it-tnaqqis fl-intensità tal-uġigħ fuq 48 siegħa ta' kura.
English: The full EPAR and risk management plan summary for Gardasil 9 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: • precancerous lesions (growths) and cancers in the cervix, vulva or vagina and anus;
Maltese: • leżjonijiet prekanċerużi (tkabbir) u kanċers fiċ-ċerviċi, fil-vulva jew fil-vaġina u l-anus;
English: In Europe, approximately 90% of anal cancers, 15% of vulvar cancers, 70% of vaginal cancers, and 30 to 40% of penile cancers are estimated to be caused by HPV infection.
Maltese: Fl-Ewropa, madwar 90% tal-kanċers tal-anus, 15% tal-kanċer vulvari, 70% tal-kanċers tal-vaġina, u 30 sa 40% tal-kanċers tal-pene huma stmati li huma kkawżati minn infezzjoni HPV.
English: This is a summary of the European public assessment report (EPAR) for Gardasil 9.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Gardasil 9.
English: These side effects were normally mild or moderate.
Maltese: Dawn l-effetti sekondarji kienu normalment ħfief jew moderati.
English: human papillomavirus 9-valent vaccine (recombinant, adsorbed)
Maltese: Sommarju tal-EPAR għall-pubbliku vaċċin 9-valent tal-vajrus tal-papilloma uman (rikombinanti, adsorbit)
English: Nearly 100% of cervical cancers are caused by HPV infection.
Maltese: Kważi 100% tal-kanċers ċervikali huma kkawżati minn infezzjoni HPV.
English: Gardasil 9
Maltese: Informazzjoni oħra dwar Gardasil 9