FrancophonIA/ELRC3.0 huggingface dataset:
English: The efficacy and safety of Provenge in patients with asymptomatic or minimally symptomatic metastatic castrate resistant prostate cancer were studied in three similar Phase III, randomised, double-blind, controlled, multicentre trials: D9902B (IMPACT), D9901, and D9902A.
Maltese: L-effikaċja u s-sigurtà ta' Provenge f'pazjenti b'kanċer tal-prostata metastatiku asintomatiku jew minimament sintomatiku li hu reżistenti għall-kastrazzjoni ġew studjati fi tliet provi multiċentriċi, ikkontrollati, bi blindaġġ doppju, aleatorji simili tal-Fażi III: D9902B (IMPACT), D9901, u D9902A.
English: Atrial fibrillation Myocardial infarction Myocardial ischaemia
Maltese: Infart mijokardijaku Iskemija mijokardijaka
English: Bacteraemia
Maltese: Batteremija
English: Dendreon UK Limited 41 Chalton Street London, NW1 1JD United Kingdom
Maltese: Dendreon UK Limited 41 Chalton Street London, NW1 1JD Ir-Renju Unit
English: IMPACT study
Maltese: IMPACT
English: The clinical significance is uncertain.
Maltese: L-importanza klinika hija inċerta.
English: Figure 1 Kaplan-Meier overall survival curve, IMPACT study
Maltese: Figura 1 Kurva tas-sopravivenza ġenerali ta' Kaplan-Meier, l-istudju IMPACT
English: Additional adverse reactions that were seen commonly ≤ 1 day following a leukapheresis procedure in controlled clinical trials included fatigue (5.5%), muscle spasm (4.0%), chills (3.0%), dizziness (2.8%), and anaemia (2.8%).
Maltese: Reazzjonijiet avversi oħrajn li dehru b'mod komuni ≤ 1 jum wara proċedura ta' lewkafereżi fil-provi kliniċi kkontrollati inkludew għeja (5.5%), spażmi tal-muskoli (4.0%), dehxiet ta' bard (3.0%), sturdament (2.8%), u anemija (2.8%).
English: Fevers and chills generally resolved within 2 days (71.9% and 89.0%, respectively).
Maltese: Ġeneralment, id-deni u d-dehxiet ta' bard għaddew fi żmien jumejn (71.9% u 89.0%, rispettivament).
English: All patients had baseline testosterone levels < 50 ng/mL.
Maltese: Il-pazjenti kollha kellhom livelli tat-testosteron tal-linja bażi < 50 ng/mL.
English: The following list of adverse reactions is based on experience from clinical trials and on postmarketing experience and are displayed by system organ class and frequency of occurrence: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to
Maltese: wara t-tqegħid fis-suq u jintwerew skont is-sistema tal-klassifika tal-organi u l-frekwenza ta' kemm iseħħu: komuni ħafna (≥1/10), komuni (≥1/100 sa <1/10), mhux komuni (≥1/1,000 sa <1/100), rari
English: Adverse reactions that were reported most commonly ≤ 1 day following a leukapheresis procedure in controlled clinical trials included citrate toxicity (14.6%), oral paraesthesia (12.0%), and paraesthesia (11.1%).
Maltese: Reazzjonijiet avversi li ġew irrapportati l-iktar ≤ 1 jum wara proċedura ta' lewkafereżi fil-provi kliniċi kkontrollati inkludew tossiċità taċ-ċitrat (14.6%), parestesija orali (12.0%), u parestesija (11.1%).
English: Table 1 Adverse reactions from clinical studies and post-marketing reports System organ class
Maltese: Tabella 1 Reazzjonijiet avversi minn studji kliniċi u rapporti wara t-tqegħid fis-suq
English: Summary of study results Table 2 presents overall survival results observed in IMPACT, study D9901, and study D9902A.
Maltese: It-Tabella 2 tippreżenta riżultati tas-sopravivenza ġenerali osservati f'IMPACT, l-istudju D9901, u l istudju D9902A.
English: a b b p-value
Maltese: Valur p c c
English: Provenge is an autologous cellular therapy.
Maltese: Provenge huwa terapija ċellolari awtologa.
English: The other ingredients are: sodium chloride, sodium lactate, potassium chloride, and calcium chloride.
Maltese: Is-sustanzi l-oħra huma: sodium chloride, sodium lactate, potassium chloride, u calcium chloride.
English: Secondary endpoints included time to objective disease progression, time to clinical progression, and PSA doubling time (PSADT).
Maltese: Il-punti finali sekondarji inkludew żmien għal progressjoni oġġettiva tal-marda, żmien għall-progressjoni klinika, u ż-żmien tar-raddoppjar tal-PSA (PSADT).
English: Vital signs should be taken at least 30 minutes prior to and 30 minutes following each infusion.
Maltese: Għandhom jittieħdu sinjali vitali tal-inqas 30 minuta qabel u 30 minuta wara kull infużjoni.
English: A statistically significant improvement in overall survival was seen in patients treated with Provenge, with a 22.5% reduction in the risk of death compared with control (see Table 2 and Figure 1).
Maltese: Deher titjib statistikament notevoli fis-sopravivenza ġenerali tal-pazjenti kkurati bi Provenge, bi tnaqqis ta' 22.5% fir-riskju ta' mewt meta mqabbla mal-kontroll (ara t-Tabella 2 u l-Figura 1).
English: Subsequently, the marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Maltese: Sussegwentement, id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq għandu jippreżenta rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott f'konformità mar-rekwiżiti mniżżla fil-lista tad dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u ppubblikati fuq il-portal elettroniku Ewropew tal-mediċini.
English: In controlled clinical trials, 71.2% of patients in the Provenge group developed an acute infusion reaction.
Maltese: Fil-provi kliniċi kkontrollati, 71.2% tal-pazjenti fil-grupp ta' Provenge żviluppaw reazzjoni akuta għall-infużjoni.
English: Once the infusion is complete you will be observed and monitored for at least 30-60 minutes, after which, you may go home.
Maltese: Ladarba titlesta l-infużjoni, ser tiġi osservat u ssorveljat għal tal-inqas 30-60 minuta, u wara, tista' tmur id-dar.
English: In clinical study D9902B (IMPACT), 237 out of the 512 patients randomized were evaluated for the development of humoral or cellular immune responses (T cell proliferation and gamma-interferon
Maltese: Fl-istudju kliniku D9902B (IMPACT), 237 mill-512-il pazjent aleatorji ġew evalwati għall-iżvilupp ta' rispons immuni umorali jew ċellolari (proliferazzjoni taċ-ċellola T u gamma-interferon (γIFN) ELISPOT) fl-antiġeni fil-mira fil-linja bażi, u fil-Ġimgħat 6, 14, u 26.
English: Serious adverse reactions include acute infusion reactions, catheter sepsis, staphylococcal bacteraemia, myocardial infarction, and cerebrovascular events.
Maltese: Reazzjonijiet avversi serji jinkludu reazzjonijiet akuti għall-infużjoni, sepsis tal-katiter, batteremija stafilokokkali, infart mijokardijaku u avvenimenti ċerebrovaskulari.
English: Citrate toxicity*
Maltese: Tossiċità ċitrika*
English: After removal from the insulated container
Maltese: Fil-kontenitur insulat
English: In controlled clinical trials, cerebrovascular events (hemorrhagic and ischaemic strokes) were observed in 3.5% of patients in the Provenge group compared with 2.6% of patients in the control group.
Maltese: Fi provi kliniċi kkontrollati ġew osservati avvenimenti ċerebrovaskulari (puplesiji emorraġiċi u iskemiċi) fi 3.5% tal-pazjenti fil-grupp ta' Provenge meta mqabbla ma' 2.6% tal-pazjenti fil-grupp ta'
English: In controlled clinical trials, infection occurred in 27.5% of subjects in the Provenge group and 27.7% of subjects in the control group.
Maltese: Fi provi kliniċi kkontrollati, infezzjoni seħħet f'27.5% tas-soġġetti fil-grupp ta' Provenge u 27.7% tassuġġetti fil-grupp ta' kontroll.
English: Eighty-two percent of patients had an ECOG performance status of 0; 75% had a Gleason sum ≤ 7; 44% had bone and soft tissue disease; 48% had bone-only disease; 7% had soft tissue-only disease; and 43% had greater than ten bony metastases.
Maltese: Tnejn u tmenin fil-mija tal-pazjenti kellhom status ta' prestazzjoni tal-ECOG ta' 0; 75% kellhom somma Gleason ≤ 7; 44% kellhom mard tal-għadam u tat-tessut artab; 48% kellhom marda tal-għadam biss; 7% kellhom marda tat-tessut artab biss; u 43% kellhom iktar minn għaxar metastasi fl-għadam.
English: In controlled clinical trials, severe (Grade 3) acute infusion reactions were reported in 3.5% of patients in the Provenge group.
Maltese: Fi provi kliniċi kkontrollati, reazzjonijiet akuti severi (Grad 3) għall-infużjoni ġew irrapportati fi 3.5% tal-pazjenti fil-grupp ta' Provenge.
English: Respiratory, thoracic, and mediastinal disorders
Maltese: Disturbi respiratorji, toraċiċi,
English: Other medicines and Provenge
Maltese: Mediċini oħra u Provenge
English: This medicinal product contains approximately 800 mg of sodium and 45 mg of potassium per infusion.
Maltese: Dan il-prodott mediċinali fih madwar 800 mg sodju u 45 mg potassju għal kull infużjoni.
English: A total of 512 patients were randomised in a 2:1 ratio to receive Provenge (n=341) or control (n=171).
Maltese: Total ta' 512-il pazjent tqassmu b'mod aleatorju bi proporzjon ta' 2:1 biex jirċievu Provenge (n=341)
English: - rash, including raised itchy rash (urticaria), or itching
Maltese: - raxx, inkluż raxx imqabbeż li jieklok (urtikarja), jew ħakk
English: A retrospective subgroup analysis has suggested a greater Provenge treatment effect in patients with a baseline PSA < 22.1 ng/mL [HR= 0.521 (95% CI: 0.309, 0.879)].
Maltese: Analiżi retrospettiva tas-sottogrupp issuġġeriet effett ikbar tal-kura bi Provenge f'pazjenti b'PSA tallinja bażi < 22.1 ng/mL [HR= 0.521 (95% CI: 0.309, 0.879)].
English: For full instructions on the preparation and handling of Provenge, see section 6.6.
Maltese: Għal struzzjonijiet sħaħ fuq il-preparazzjoni u l-maniġġ ta' Provenge, ara s-sezzjoni 6.6.
English: Serious infections occurred in 4.7% of subjects in the Provenge group and 4.0% of subjects in the control group.
Maltese: Infezzjonijiet serji seħħew f'4.7% tas-suġġetti fil-grupp ta' Provenge u 4.0% tas-suġġetti fil-grupp ta' kontroll.
English: In addition, your blood will be tested for specific viruses (for example HIV-1, HIV-2, hepatitis B and hepatitis C).
Maltese: Barra minn hekk, id-demm tiegħek ser jiġi ttestjat għal vajrusis speċifiċi (pereżempju HIV-1, HIV-2, epatite B u epatite Ċ).
English: Exclusion criteria included visceral (liver, lung, or brain) metastases, malignant pleural effusions or malignant ascites, pathologic long bone fractures, imminent pathologic long-bone fractures (cortical erosion on radiography >50%), spinal cord compression, moderate to severe prostate cancer-related pain and use of narcotics for cancerrelated pain, and treatment with chemotherapy at least 3 months prior to randomisation.
Maltese: Il-kriterji ta' esklużjoni kienu jinkludu metastasi vixxerali (fwied, pulmun, jew moħħ), effużjonijiet plewrali malinni jew axxiti malinni, ksur patoloġiku tal-għadam fittul, ksur patoloġiku imminenti tal-għadam twil (erożjoni kortikali fuq ir-radjografija >50%), kompressjoni tas-sinsla tad-dahar, uġigħ moderat sa sever relatat mal-kanċer tal-prostata u l-użu ta' narkotiċi għal uġigħ relatat mal-kanċer, u l-kura b'kemoterapija tal-inqas 3 xhur qabel il-fażi tat tqassim aleatorju.
English: A smaller treatment effect was observed in those with baseline PSA > 134.1 ng/mL [HR=0.853 (95% CI: 0.554, 1.315)].
Maltese: Ġie osservat effett iżgħar tal-kura f'dawk b'PSA tal-linja bażi > 134.1 ng/mL [HR=0.853 (95% CI: 0.554, 1.315)].
English: * Primarily associated with the leukapheresis procedure
Maltese: * Primarjament assoċjati mal-proċedura tal-lewkafereżi
English: Other side effects with Provenge include:
Maltese: Effetti sekondarji oħrajn bi Provenge jinkludu:
English: Tabulated list of adverse reactions
Maltese: Lista mqassma f'tabella tar-reazzjonijiet avversi
English: ▼ This medicine is subject to additional monitoring.
Maltese: ▼ Dan il-prodott mediċinali huwa suġġett għal monitoraġġ addizzjonali.
English: Hypoaesthesia Spinal cord compression Syncope
Maltese: Għafis tal-korda spinali Sinkope
English: Potassium chloride Calcium chloride.
Maltese: Sodium chloride Sodium lactate Potassium chloride Calcium chloride.
English: Reports of serious infection have been received in post-marketing surveillance including devicerelated infection, device-related sepsis, pneumonia, sepsis, bacteraemia, and urinary tract infection.
Maltese: Matul is-sorveljanza ta' wara t-tqegħid fis-suq daħlu rapporti ta' infezzjoni serja, inkluż infezzjoni relatata mal-apparat, sepsis relatata mal-apparat, pulmonite, sepsis, batteremija, u infezzjoni fl-apparat tal-awrina.
English: The safety evaluation of Provenge is based on data from 601 prostate cancer patients in four randomized, controlled clinical trials (3 studies in metastatic castrate resistant prostate cancer and 1 study in androgen dependent prostate cancer) and post-marketing surveillance.
Maltese: L-evalwazzjoni tas-sikurezza ta' Provenge hija bbażata fuq dejta minn 601 pazjent bil-kanċer talprostata f'erba' provi kliniċi aleatorji kkontrollati (3 studji f'kanċer tal-prostata metastatiku reżistenti għall-kastrazzjoni u studju wieħed f'kanċer tal-prostata dipendenti fuq l-androġeni) u sorveljanza ta'
English: 36-month survival (%) a Hazard ratio and p-value based on the Cox Model adjusted for PSA (ln) and LDH (ln) and stratified by bisphosphonate use, number of bone metastases, and primary Gleason grade.
Maltese: 36 xahar (%) a Il-proporzjon ta' periklu u l-valur p ibbażati fuq il-Mudell Cox aġġustat għall-PSA (ln) u LDH (ln) u mqassam skont l-użu tal-bisfosfonat, in-numru ta' metastasi fl-għadam, u l-grad primarju ta' Gleason.
English: Paraesthesia* Paraesthesia oral* Headache
Maltese: Parasteżija orali* Uġigħ ta' ras
English: Infusion-related side effects
Maltese: Effetti sekondarji relatati mal-infużjoni
English: Exp.
Maltese: Provenge.
English: Submission of study protocol with first PSUR
Maltese: Sottomissjoni tal-protokoll ta' studju malewwel PSUR
English: Catheter sepsis Catheter related infection Catheter site infection Sepsis
Maltese: - infezzjoni severa fid-demm minn kateter kontaminat (sepsis minn kateter) - infezzjoni minn kateter kontaminat (infezzjoni relatata mal-kateter)
English: Interim data submitted in each PSUR Final study report by 31 December 2018
Maltese: Dejta interim sottomessa f'kull PSUR Rapport tal-istudju finali sal31 ta' Diċembru 2018
English: In controlled clinical trials, myocardial infarctions were observed in 0.8% of patients in the Provenge group compared with 0.3% of patients in the control group.
Maltese: Fi provi kliniċi kkontrollati, ġew osservati infarti mijokardijaċi f'0.8 % tal-pazjenti fil-grupp ta'
English: Dendreon UK Ltd. 41 Chalton Street London, NW1 1JD United Kingdom
Maltese: 41 Chalton Street London, NW1 1JD Ir-Renju Unit
English: In post-marketing experience of greater than 5,000 patients treated, this incidence is approximately 19% (see section 4.4).
Maltese: F'esperjenza ta' wara t-tqegħid fis-suq ta' aktar minn 5,000 pazjent ikkurati, din l inċidenza hija ta' madwar 19% (ara s-sezzjoni 4.4).
English: • approximately 800 mg sodium per infusion.
Maltese: • madwar 800 mg sodju f'kull infużjoni.
English: Neutralising antibody responses to GM-CSF were transient.
Maltese: Ir-risponsi tal-antikorpi newtralizzanti għal GM-CSF għebu fi ftit żmien.
English: Provenge 50 x 106 CD54+ cells/250mL dispersion for infusion.
Maltese: PROVENGE 50 x 106 CD54+ ċelloli/250 mL dispersjoni għal infużjoni.
English: 250 mL dispersion in a bag (breathable polyolefin tri-laminate with 3 sample ports (2 spike ports and 1 port with sealed tubing)).
Maltese: 250 mL dispersjoni f'borża (trilaminata tal-poljolefina li minnha tgħaddi l-arja bi 3 ports tal-kampjuni
English: Provenge is an autologous cellular immunotherapy designed to induce an immune response targeted against prostatic acid phosphatase (PAP), an antigen expressed in most prostate cancers.
Maltese: Provenge huwa immunoterapija ċellolari awtologa mfassla sabiex tniedi rispons immuni mmirat kontra fosfatażi aċiduża tal-prostata (PAP), antiġenu li jidher f'ħafna mill-kanċers tal-prostata.
English: <1/1,000), very rare (<1/10,000), and not known (cannot be estimated from the available data).
Maltese: (≥1/10,000 sa <1/1000), ferm rari (<1/10,000), u mhux magħruf (ma tistax tittieħed stima mid-dejta disponibbli).
English: Provenge is released for infusion based on the microbial and sterility results from several tests: microbial contamination determination by Gram stain, endotoxin content, and in-process sterility with a 2-day incubation to determine absence of microbial growth.
Maltese: Testijiet mikrobijoloġiċi Provenge jiġi rilaxxat għal infużjoni fuq il-bażi tar-riżultati mikrobjali u tal-isterilità minn bosta testijiet: determinazzjoni tal-kontaminazzjoni mikrobjali bit-tilwin Gram, kontenut ta' endotossini, u sterilità fil-proċess b'inkubazzjoni ta' jumejn għad-determinazzjoni tan-nuqqas ta' tkabbir mikrobjali.
English: BATCH NUMBER, DONATION AND PRODUCT CODES Lot /COI {lot number/chain of identity} First Name, Middle Initial, Last Name {patient name} DOB {patient date of birth}
Maltese: NUMRU TAL-LOTT, DONAZZJONI U KOWD TAL-PRODOTT Lott /COI {numru tal-lott/katina tal-identità} L-isem, Inizjali tan-nofs, Kunjom {isem il-pazjent} DOB {data tat-twelid tal-pazjent}
English: In controlled clinical trials, 25.4% of patients treated with Provenge required more than 3 leukapheresis procedures in order to receive 3 infusions.
Maltese: Fi provi kliniċi kkontrollati, 25.4 % tal-pazjenti kkurati bi Provenge kienu jeħtieġu aktar minn 3 proċeduri ta' lewkafereżi sabiex jirċievu 3 infużjonijiet.
English: The degree of CD54 upregulation correlates with overall survival in the randomised controlled clinical trials carried out with Provenge in metastatic castrate resistant prostate cancer.
Maltese: APC u ċellola T. Il-grad ta' sovraregolazzjoni ta' CD54 huwa korrelatat mas-sopravivenza ġenerali fil provi kliniċi kkontrollati aleatorji mwettqa bi Provenge f'kanċer tal-prostata metastatiku reżistenti għall-kastrazzjoni.
English: Patients treated with Provenge had a statistically significant survival advantage compared with control.
Maltese: Ilpazjenti li rċievew kura bi Provenge kellhom vantaġġ ta' sopravivenza statistikament importanti meta mqabbla mal-kontroll.
English: Cerebral infarction
Maltese: Infart ċerebrali
English: Pharmacotherapeutic group: Immunostimulants, other immunostimulants, ATC code: L03AX17.
Maltese: Immunostimolanti, immunostimolanti oħrajn, Kodiċi ATC:
English: Intermediate results were observed in patients with baseline PSA > 22.1 to 50.1 ng/mL [HR=0.685 (95% CI: 0.431, 1.088)] and patients with baseline PSA > 50.1 to 134.1 ng/mL [HR=0.819 (95% CI: 0.532, 1.262)].
Maltese: Ġew osservati riżultati intermedji f'pazjenti b'PSA tal-linja bażi > 22.1 sa 50.1 ng/mL [HR=0.685 (95% CI: 0.431, 1.088)] u pazjenti bil
English: Eligible patients had metastatic disease in the soft tissue and/or bone with current or historical evidence of disease progression concomitant with surgical or medical castration, as evidenced by progression of serum prostate specific antigen (PSA) and/or bone or soft tissue disease, and an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Maltese: Il-pazjenti eliġibbli kellhom marda metastatika fit-tessut artab u/jew fl-għadam b'evidenza attwali jew fl-imgħoddi ta' progressjoni tal-marda fl-istess ħin mal-kastrazzjoni kirurġika jew medika, kif muri mill-progressjoni tal-antiġenu speċifiku għall-prostata (PSA) tas-serum u/jew mard tal-għadam jew tat-tessut artab, u status ta' prestazzjoni tal-Grupp tal-Onkoloġija Kooperattiva tal-Lvant (ECOG) ta' 0 jew 1.
English: • Provenge is shipped directly to the medical facility where the infusion will be administered.
Maltese: • Provenge jintbagħat direttament lill-faċilità medika fejn ser tingħata l-infużjoni.
English: Acute infusion reactions (reported within 1 day of infusion) included, but were not limited to, fever, chills, respiratory events (dyspnoea, hypoxia, and bronchospasm), nausea, vomiting, fatigue, hypertension, and tachycardia.
Maltese: Reazzjonijiet akuti għall-infużjoni (irrapportati fi żmien jum mill-infużjoni) inkludew, iżda ma kinux limitati għal, deni, dehxiet ta' bard, avvenimenti respiratorji (dispnea, ipossija, u brankospażmi), dardir, rimettar, għeja, pressjoni għolja u takikardija.
English: There is no relevant use of Provenge in the paediatric population in children and adolescents less than 18 years of age in the indication of asymptomatic or minimally symptomatic metastatic (non-visceral) castrate resistant prostate cancer in male adults in whom chemotherapy is not yet clinically indicated.
Maltese: Ma hemm l-ebda użu relevanti ta' Provenge fil-popolazzjoni pedjatrika fi tfal u adolexxenti ta' inqas minn 18-il sena fl-indikazzjoni ta' kanċer tal-prostata metastatiku (mhux vixxerali) reżistenti għallkastrazzjoni li hu asintomatiku jew minimament sintomatiku f'irġiel adulti li fihom, il-kimoterapija għadha ma ġietx indikata klinikament.
English: For patients with cardiovascular disease or those at risk for cardiac ischaemia, physicians should consider observing patients for at least 60 minutes following each infusion with vital signs taken at 30 minutes and 60 minutes following the infusion.
Maltese: Għall-pazjenti b'marda kardjovaskulari jew dawk f'riskju ta' iskemija kardijaka, it-tobba għandhom jieħdu f'kunsiderazzjoni osservazzjoni talpazjenti għal tal-inqas 60 minuta wara kull infużjoni bis-sinjali vitali meħuda wara 30 u 60 minuta mill-infużjoni.
English: • You have not received the Final Product Disposition Notification form.
Maltese: • Ma rċevejtx il-formola ta' Notifika ta' Użu tal-Prodott Finali.
English: How to store Provenge
Maltese: X'fih Provenge
English: Provenge is designed to stimulate your immune system, and therefore it may not be appropriate to be treated with Provenge if you are currently taking other treatments that could affect the ability of your immune system to respond to Provenge e.g., immunosuppressant medicines such as those used to treat or prevent organ rejection and certain medicines used to treat rheumatoid arthritis, multiple sclerosis, Crohn's disease, and ulcerative colitis.
Maltese: Provenge għandu l-għan li jistimula s-sistema immuni tiegħek, u għaldaqstant, jista' ma jkunx xieraq li tingħata l-kura bi Provenge jekk diġà qed tieħu kuri oħrajn li jistgħu jaffettwaw il-ħila tas-sistema immuni tiegħek biex twieġeb għal Provenge, eż. mediċini immunosuppressanti bħal dawk użati għallkura jew għall-prevenzjoni ta' rifjut ta' organi u ċerti mediċini użati biex jikkuraw artrite rewmatojde, sklerożi multipla, il-marda ta' Crohn, u kolite ulċerattiva.
English: In 95.1% of patients reporting acute infusion reactions, the events were mild or moderate.
Maltese: 1% talpazjenti rrapportaw reazzjonijiet akuti għall-infużjoni, l-avvenimenti kienu ħfief jew moderati.
English: IgG) responses against both PAP-GM-CSF and the PAP antigens were observed in the Provenge group through the follow up period.
Maltese: Ir risponsi tal-antikorpi (IgM u IgG) kemm kontra PAP-GM-CSF kif ukoll l-antiġeni ta' PAP ġew osservati fil-grupp ta' Provenge permezz tal-perjodu ta' segwitu.
English: The incidence of severe reactions was greater following the second infusion (2.1% vs. 0.8% following the first infusion), and decreased to 1.3% following the third infusion.
Maltese: L-inċidenza ta' reazzjonijiet severi kienet ikbar wara t-tieni infużjoni (2.1% vs. 0.8% wara l-ewwel infużjoni), u naqset għal 1.3% wara t-tielet infużjoni.
English: Reactions included chills, fever, fatigue, asthenia, dyspnoea, hypoxia, bronchospasm, dizziness, headache, hypertension, muscle ache, nausea, and vomiting.
Maltese: Ir-reazzjonijiet inkludew dehxiet ta' bard, deni, għeja, astenija, dispnea, ipossija, bronkospażmi, sturdament, uġigħ ta' ras, pressjoni għolja, uġigħ fil-muskoli, nawsja, u rimettar.
English: Hyperkalaemia should be corrected prior to Provenge administration (see section 4.2).
Maltese: Iperkalemija għandha tiġi korretta qabel ma jingħata Provenge (ara sezzjoni 4.4).