FrancophonIA/ELRC3.0 huggingface dataset:
English: Simponi 50 mg solution for injection in pre-filled pen 0.5 mL solution in a pre-filled syringe (Type 1 glass) with a fixed needle (stainless steel) and a needle cover (rubber containing latex) in a pre-filled pen.
Maltese: Simponi 50 mg soluzzjoni għall-injezzjoni f'pinna mimlija għal-lest 0.5 mL ta' soluzzjoni f'siringa mimlija għal-lest (ħġieġ Tip 1) b'labra fissa (stainless steel) u għatu tal-labra (gomma li fiha l-latex) f'pinna mimlija għal-lest.
English: Common: Alanine aminotransferase increased, aspartate aminotransferase increased Uncommon: Cholelithiasis, hepatic disorders Skin and subcutaneous tissue disorders
Maltese: Żieda ta' alanine aminotransferase, żieda ta' aspartate aminotransferase Mhux komuni:
English: A starting dose of 200 mg (the contents of 4 pre-filled syringes) followed by 100 mg (the contents of 2 pre-filled syringes) 2 weeks later.
Maltese: Doża tal-bidu ta' 200 mg (il-kontenut ta' 4 siringi mimlija għal-lest) segwita minn 100 mg (il-kontenut ta' 2 siringi mimlija għal-lest) ġimagħtejn wara.
English: België/Belgique/Belgien MSD Belgium BVBA/SPRL Tél/Tel: +32(0)27766211 dpoc_belux@merck.com
Maltese: +32(0)27766211 dpoc_belux@merck.com
English: Hold firmly.
Maltese: Proċessi awtoimmuni
English: In the controlled and uncontrolled periods of the pivotal trials with a median follow-up of up to 3 years, a greater incidence of demyelination was observed in patients receiving golimumab 100 mg compared with patients receiving golimumab 50 mg (see section 4.4).
Maltese: Fil-perjodi kkontrollati u mhux ikkontrollati tal-provi pivitali b'segwitu medjan sa 3 snin, kienet osservata inċidenza ogħla ta' demajlinazzjoni fil-pazjenti li kienu qed jirċievu golimumab 100 mg meta mqabbel mal-pazjenti li kienu qed jirċievu golimumab 50 mg (ara sezzjoni 4.4).
English: Therapeutic infectious agents should not be given concurrently with golimumab (see section 4.4).
Maltese: Sustanzi terapewtiċi infettivi m'għandhomx jingħataw flimkien ma' golimumab (ara sezzjoni 4.4).
English: • You may get infections more easily while using Simponi.
Maltese: • Jistgħu jaqbduk infezzjonijiet aktar malajr meta tkun qed tuża Simponi.
English: This rare type of T-cell lymphoma has a very aggressive disease course and is usually fatal.
Maltese: Din it-tip rari ta' limfoma taċ-ċellula T għandha kors ta' marda aggressiva ħafna u normalment hija fatali.
English: • the number of pre-filled syringes and strength is correct o If your dose is 100 mg, you will get one 100 mg pre-filled syringe o If your dose is 200 mg, you will get two 100 mg pre-filled syringes and you will need to give yourself two injections.
Maltese: • in-numru ta' pinen mimlija għal-lest u l-qawwa huma korretti o Jekk id-doża tiegħek hija 100 mg, inti se tieħu pinna waħda mimlija għal-lest ta' 100 mg o Jekk id-doża tiegħek hija ta' 200 mg, inti se tingħata żewġ pinen mimlija għal-lest ta' 100 mg u se jkollok bżonn tagħti lilek innifsek żewġ injezzjonijiet.
English: The co-primary endpoints were the percentage of patients achieving ACR 20 response at week 14 and change from baseline in total PsA modified vdH-S score at week 24.
Maltese: Il-miri finali ko-ewlenin kienu l-perċentwali ta' pazjenti li kisbu rispons ACR 20 f'ġimgħa 14 u l-bidla mil-linja bażi fil-punteġġ vdH-S modifikat ta' PsA totali f'ġimgħa 24.
English: Simponi 45 mg/0.45 mL solution for injection in pre-filled pen For paediatric patients below 40 kg golimumab
Maltese: Simponi 45 mg/0.45 mL soluzzjoni għall-injezzjoni f'pinna mimlija għal-lest Għal pazjenti pedjatriċi li jiżnu anqas minn 40 kg golimumab
English: In GO-FORWARD clinically meaningful and statistically significant improvements were demonstrated in health-related quality of life as measured by the physical component score of the SF-36 in patients treated with Simponi versus placebo at week 24.
Maltese: F'GO-FOWARD titjib li kellu sinifikat kliniku u statistikament sinifikanti intwerew fil-kwalità tal-ħajja relatata mas-saħħa kif imkejjel mill-punteġġ tal-komponent fiżiku ta' SF-36 f'pazjenti ikkurati b'Simponi kontra l-plaċebo f'ġimgħa 24.
English: During maintenance treatment, corticosteroids may be tapered in accordance with clinical practice guidelines.
Maltese: Waqt kura ta' manteniment, kortikosterojdi jistgħu jitnaqqsu għax-xejn skont il-linji gwida ta' prattika klinika.
English: Out of 146 patients who were randomised to Simponi 50 mg, 52 week X-ray data were available for 126 patients, of whom 77% showed no progression compared to baseline.
Maltese: Mill-146 pazjent li kienu randomised biex jirċievu Simponi 50 mg, kienet disponibbli dejta ta' 52 ġimgħa minn X-ray għal 126 pazjent, li minnhom 77% ma wrew l-ebda progressjoni meta mqabbla mal-linja bażi.
English: In controlled Phase IIb and/or III trials in RA, PsA, AS, nr-Axial SpA, severe persistent asthma, and Phase II/III trials in UC, no patients treated with golimumab developed anaphylactic reactions.
Maltese: IIb u/jew III ta' RA, PsA, AS, nr-Axial SpA, ażma severa u persistenti, u provi ta' Fażi
English: • Positive blood lupus test
Maltese: • Test tad-demm għall-lupus pożittiv
English: Uncommon: Breast disorders, menstrual disorders
Maltese: Mhux komuni: Disturbi fis-sider, disturbi mestrwali
English: For all of the above indications, in patients with RA, PsA, AS, or nr-Axial SpA with a body weight of more than 100 kg who do not achieve an adequate clinical response after 3 or 4 doses, increasing the dose of golimumab to 100 mg once a month may be considered, taking into account the increased risk of certain serious adverse reactions with the 100 mg dose compared with the 50 mg dose (see section 4.8).
Maltese: Għall-indikazzjonijiet kollha t'hawn fuq, f'pazjenti b'RA, PsA, AS, jew nr-Axial SpA b'piż tal-ġisem aktar minn 100 kg li ma jiksbux rispons kliniku adegwat wara 3 jew 4 dożi, iż-żieda tad-doża ta' golimumab għal 100 mg darba fix-xahar tista' tiġi kkunsidrata, billi wieħed jikkunsidra iż-żieda firriskju ta' ċerti reazzjonijiet avversi serji bid-doża ta' 100 mg meta mqabbla mad-doża ta' 50 mg (ara sezzjoni 4.8).
English: Check the window - a yellow indicator confirms proper administration (see figure 9)
Maltese: Iċċekkja t-tieqa mnejn tara - indikatur isfar jikkonferma li l-għoti sar sewwa (ara figura 9)
English: • Flu
Maltese: • Influwenza
English: You must stop breast-feeding if you are to be given Simponi.
Maltese: Każijiet ta' lewkimja kienu rrappurtati f'pazjenti ikkurati b'Simponi.
English: A starting dose of 200 mg (the contents of 4 pre-filled pens) followed by 100 mg (the contents of 2 pre-filled pens) 2 weeks later.
Maltese: Doża tal-bidu ta' 200 mg (il-kontenut ta' 4 pinen mimlija għal-lest) segwita minn 100 mg (il-kontenut ta' 2 pinen mimlija għal-lest) ġimagħtejn wara.
English: • Cold sores
Maltese: • Tħossok sturdut
English: Simponi should be given concomitantly with MTX.
Maltese: Simponi għandu jingħata flimkien ma' MTX.
English: At week 16, 34% of children had inactive disease defined as having the presence of all of the following: no joints with active arthritis; no fever, rash, serositis, splenomegaly, hepatomegaly, or generalised lymphadenopathy attributable to JIA; no active uveitis; normal ESR (< 20 mm/hour) or CRP (< 1.0 mg/dL); physician global assessment of disease activity (≤ 5 mm on the VAS); duration of morning stiffness < 15 minutes.
Maltese: F'ġimgħa 16, 34% tat-tfal kellhom mard inattiv iddefinit li jkollu preżenti kull waħda minn dawn li ġejjin: l-ebda ġog b'artrite attiva; l-ebda deni, raxx, serosite, tkabbir mhux normali tal-frixa, tkabbir mhux normali tal-fwied, jew limfadenopatija mifruxa attribwita għal JIA; l-ebda uveite attiva;
English: CARTON FOR 1 PRE-FILLED PEN AS INTERMEDIATE PACK / COMPONENT OF A MULTIPACK (WITHOUT BLUE BOX)
Maltese: KARTUNA TA' PINNA 1 MIMLIJA GĦAL-LEST BĦALA PAKKETT TAN-NOFS/ KOMPONENT TA' PAKKETT B'ĦAFNA (MINGĦAJR KAXXA ĊELESTI)
English: • Headache
Maltese: • Axxess
English: Sixty-eight percent (21/31) of antibody-positive patients had neutralising antibodies in vitro.
Maltese: Tmienja u sittin fil-mija (21/31) tal-pazjenti pożittivi għall-antikorpi kellhom antikorpi li jinnewtralizzaw in vitro.
English: • If you are allergic (hypersensitive) to golimumab or any of the other ingredients of this medicine (listed in Section 6).
Maltese: • Jekk inti allerġiku għal golimumab jew għal xi sustanza oħra ta' din il-mediċina (imniżżla fis sezzjoni 6).
English: • Psoriasis (including on the palms of your hand and/or the soles of your feet and/or in the form of skin blisters)
Maltese: • Psorjasi (inkluż il-pali ta' jdejk u/jew il-qiegħ ta' saqajk u/jew forma ta' bżieżaq żgħar fil-ġilda)
English: Patients receiving placebo were switched to Simponi 50 mg after week 24.
Maltese: Il-pazjenti li kienu qed jirċievu l-plaċebo inqalbu għal Simponi 50 mg wara ġimgħa 24.
English: Polyarticular juvenile idiopathic arthritis in children with body weight less than 40 kg The recommended dose of Simponi for children with a body weight less than 40 kg with polyarticular juvenile idiopathic arthritis is 30 mg/m2 body surface area up to maximum single dose of 40 mg administered once a month, on the same date each month.
Maltese: Artrite poliartikulari idjopatika tat-tfal u ż-żgħażagħ fi tfal b'piż tal-ġisem inqas minn 40 kg Id-doża rrakkomandata ta' Simponi għal tfal b'piż tal-ġisem inqas minn 40 kg b'artrite poliartikulari idjopatita tat-tfal u ż-żgħażagħ hija 30 mg/m2 ta' erja tas-superfiċje tal-ġisem sa doża massima singola ta' 40 mg mogħtija darba f'xahar, fl-istess data kull xahar.
English: • In patients weighing 80 kg or more, 100 mg (the contents of 2 pre-filled syringes) 4 weeks after your last treatment, then every 4 weeks thereafter.
Maltese: • F'pazjenti li jiżnu 80 kg jew aktar, 100 mg (il-kontenut ta' 2 siringi mimlija għal-lest) 4 ġimgħat wara l-aħħar kura tiegħek, u minn hemm 'il quddiem kull 4 ġimgħat.
English: General disorders and administration site conditions Common: Pyrexia, asthenia, injection site reaction (such as injection site erythema, urticaria, induration, pain, bruising, pruritus, irritation and paraesthesia), chest discomfort Rare: Impaired healing Injury, poisoning and procedural complications
Maltese: Komuni: Deni, astenija, reazzjoni fis-sit tal-injezzjoni (bħal ħmura fis-sit tal-injezzjoni, urtikarja, ebusija, uġigħ, tbenġil, ħakk, irritazzjoni, u paraesteżija), skumdità fis-sider Rari:
English: PRE-FILLED PEN LABEL
Maltese: Tumuri malinni fil-popolazzjoni pedjatrika
English: Golimumab is a human monoclonal antibody that forms high affinity, stable complexes with both the soluble and transmembrane bioactive forms of human TNF-α, which prevents the binding of TNF-α to its receptors.
Maltese: Golimumab huwa antikorp monoklonali uman li jifforma kumplessi stabbli li għandhom affinità qawwija, kemm mal-forom li jinħallu kif ukoll ma' dawk transmembrani bijoattivi tat-TNF-α talbniedem, li ma jħallix it-twaħħil tat-TNF-α mar-riċetturi tiegħu.
English: In GO-FORWARD clinically meaningful and statistically significant improvements were demonstrated in health-related quality of life as measured by the physical component score of the
Maltese: Intwera titjib statistikament sinifikanti fil-mobilità tas-sinsla tad-dahar kif ivvalutat permezz ta' BASMI
English: • You will hear a loud ‘click' sound - don't be alarmed.
Maltese: • Inti se tisma ħoss qawwi ‘ifaqqa' - tiħux qatgħa.
English: Simponi has been shown to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease (see section 5.1) and to improve physical function.
Maltese: Simponi intwera li jnaqqas ir-rata ta' progressjoni ta' ħsara fil-ġogi periferali kif imkejjel bl-X-rays f'pazjenti b'sottotipi poliartikulari simettriċi tal-marda (ara sezzjoni 5.1) u li jtejjeb ilfunzjoni fiżika.
English: Adequate data of treating patients who are carriers of HBV with anti-viral 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 l-HBV b'terapija antivirali flimkien ma' antagonist ta' TNF sabiex tiġi evitata l-attivazzjoni mill-ġdid tal-HBV.
English: Among patients remaining in the study and treated with Simponi, improvement in HAQ DI was similar from week 104 through week 256.
Maltese: Fost pazjenti li baqgħu flistudju u li kienu kkurati b'Simponi, effetti radjugrafiċi kienu simili minn ġimgħa 104 sa ġimgħa 256.
English: Symptoms include persistent rash, fever, joint pain and tiredness.
Maltese: Is-sintomi jinkludu raxx persistenti, deni, uġigħ fil-ġogi u għejja.
English: Simponi 100 mg solution for injection golimumab
Maltese: Simponi 100 mg soluzzjoni għall-injezzjoni golimumab
English: There were no patients age 45 and over in the nr-Axial SpA study.
Maltese: Ma kien hemm l-ebda pazjent b'età ta' 45 sena u aktar fl-istudju dwar nr-Axial SpA.
English: Lymphoma was reported in 1 patient, non-melanoma skin cancer in 2 patients, and other malignancies in 5 patients.
Maltese: Limfoma kienet irrappurtata f'pazjent 1, kanċer tal-ġilda li mhux melanoma f'2 pazjenti, u tumuri malinni oħrajn f'5 pazjenti.
English: Ankylosing spondylitis and non-radiographic axial spondyloarthritis Ankylosing spondylitis and non-radiographic axial spondyloarthritis are inflammatory diseases of the spine.
Maltese: Ankylosing spondylitis u spondiloartrite tal-assi mhux radjugrafika Ankylosing spondylitis u spondiloartrite tal-assi mhux radjugrafika huma mard infjammatorju tassinsla.
English: Live vaccines/therapeutic infectious agents Live vaccines should not be given concurrently with golimumab (see sections 4.4 and 4.6).
Maltese: Vaċċini ħajjin/sustanzi terapewtiċi infettivi Vaċċini ħajjin m'għandhomx jingħataw flimkien ma' golimumab (ara sezzjonijiet 4.4 u 4.6).
English: Treatment is to be initiated and supervised by qualified physicians experienced in the diagnosis and treatment of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, or ulcerative colitis.
Maltese: Il-kura għandha tinbeda u tingħata taħt is-superviżjoni ta' speċjalisti kwalifikati li jkollhom esperjenza fid-dijanjożi u l-kura ta' artrite rewmatojde, artrite psorijatika, ankylosing spondylitis, spondiloartrite tal-assi mhux radjugrafika jew kolite ulċerattiva.
English: Patients enrolled in this study had active disease (defined as a BASDAI ≥ 4 and a Visual Analogue Scale (VAS) for total back pain of ≥ 4, each on a scale of 0-10 cm) despite current or previous NSAID therapy and had not previously been treated with any biological agents including anti-TNF therapy.
Maltese: Il-pazjenti li ddaħħlu f'dan l-istudju kellhom marda attiva (definita bħala BASDAI ≥ 4 u Skala Analoga Viżwali (VAS - Visual Analogue Scale) għal uġigħ totali fid-dahar ta' ≥ 4, kull waħda fuq skala ta' 0-10 ċm) minkejja terapija attwali jew preċedenti b'NSAID u ma kinux ittrattati bl-ebda sustanza bijoloġika minn qabel inkluż terapija kontra TNF.
English: Inspect carton
Maltese: tikkawża d-deni
English: Concurrent administration of TNF-antagonists and abatacept In clinical studies concurrent administration of TNF-antagonists and abatacept has been associated with an increased risk of infections including serious infections compared to TNF-antagonists alone, without increased clinical benefit.
Maltese: L-għoti fl-istess ħin ta' antagonisti tat-TNF u abatacept Fi studji kliniċi l-għoti fl-istess ħin ta' antagonisti tat-TNF u abatacept kienet assoċjata ma' żieda firriskju ta' infezzjonijiet inklużi infezzjonijiet serji meta mqabbla ma' antagonisti tat-TNF waħidhom, mingħajr żieda fil-benefiċċju kliniku.
English: Rheumatoid arthritis is an inflammatory disease of the joints.
Maltese: Artrite rewmatojde hija marda infjammatorja tal-ġogi.
English: Consistent efficacy was seen in patients regardless of use of DMARDs (MTX, sulfasalazine and/or hydroxychloroquine), HLA-B27 antigen status or baseline CRP levels as assessed by ASAS 20 responses at week 14.
Maltese: Effikaċja konsistenti dehret fil-pazjenti irrispettivament minn jekk intużawx DMARDs (MTX, sulfasalazine u/jew hydroxychloroquine) jew le, mill-istatus tal-HLA-B27 antiġenu jew mil-livelli CRP mal-linja bażi hekk kif evalwati mir-risponsi
English: Golimumab crosses the placenta.
Maltese: Golimumab jgħaddi minn ġol-plaċenta.
English: Simponi, in combination with MTX, has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function.
Maltese: Simponi, flimkien ma' MTX, intwera li jnaqqas ir-rata ta' progressjoni tal-ħsara fil-ġogi hekk kif imkejla bl-X-rays u li jtejjeb il-funzjoni fiżika.
English: Sorbitol intolerance
Maltese: • Diffikultà biex torqod
English: Side effects may appear up to several months after the last injection.
Maltese: Effetti sekondarji jistgħu jidhru sa bosta xhur wara l-aħħar injezzjoni.
English: Luxembourg/Luxemburg MSD Belgium BVBA/SPRL Tél/Tel: (+32(0)27766211) dpoc_belux@merck.com
Maltese: (+32(0)27766211) dpoc_belux@merck.com
English: Hycamtin topotecan
Maltese: Hycamtin topotekan
English: The full EPAR for Hycamtin 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 most common side effects with Hycamtin (seen in more than 1 patient in 10) are neutropenia (low white blood cell counts), febrile neutropenia (neutropenia with fever), thrombocytopenia (low platelet counts), anaemia (low red blood cell counts), leucopenia (low white blood cell counts), nausea (feeling sick), vomiting and diarrhoea (all of which may be severe), constipation, abdominal (tummy) pain, mucositis (mouth sores), alopecia (hair loss), loss of appetite (which may be severe), infections, pyrexia (fever), asthenia (weakness) and fatigue (tiredness).
Maltese: L-effetti sekondarji l-aktar komuni b' Hycamtin (li dehru f' aktar minn pazjent 1 minn 10) huma newtropenija (tnaqqis tan-numru ta' ta' ċelloli bojod tad-demm), newtropenija febbrili (newtropenija li tikkawża d-deni), tromboċitopenija (tnaqqis fl-għadd ta' pjastrini), anemija (tnaqqis tal-għadd ta' ċelloli ħomor tad-demm), nawżja (dardir), remettar u dijarrea (li jistgħu jkunu gravi), stitikezza, uġigħ addominali (ta' żaqq), mukożite (selħiet fil-ħalq), alopeċja (telf ta' xagħar), anoressija (telf ta' aptit, li jista' jkun gravi), piressija (deni), astenija (debbulizza) u għeja.
English: It is available as a powder to be made up into a solution for infusion (drip) into a vein and as capsules (0.25 and 1 mg).
Maltese: Huwa disponibbli bħala trab biex jitħallat f'soluzzjoni għall-infużjoni (dripp) u bħala kapsuli (0.25 u 1 mg)
English: Hycamtin is a cancer medicine that contains the active substance topotecan.
Maltese: Hycamtin huwa mediċina li fih s-sustanza attiva topotekan.
English: This is a summary of the European public assessment report (EPAR) for Hycamtin.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Hycamtin.
English: The active substance in Hycamtin, topotecan, is a cancer medicine that belongs to the group ‘topoisomerase inhibitors'.
Maltese: Is-sustanza attiva ta' Hycamtin, topotekan, hija mediċina kontra l-kanċer li tappartjeni għall-grupp tal‘inibituri tat-topoisomerażi'.
English: One study compared Hycamtin capsules with symptom control alone and another compared Hycamtin as an infusion with cyclophosphamide, doxorubicin and vincristine (a standard combination of chemotherapy).
Maltese: Studju wieħed qabbel kapsuli ta' Hycamtin mal-kontroll tas-sintomi waħdu filwaqt li ieħor qabbel Hycamtin mogħti bħala infużjoni maċ-ċiklofosfamide (cyclophosphamide), doksorubiċin u vinkristina (vincristine) (kombinazzjoni standard tal-kimoterapija).
English: In the main study, 21% of the patients who received Hycamtin (23 out of 112) responded to treatment, compared with 14% of the paclitaxel patients (16 out of 114).
Maltese: Fl-istudju ewlieni, 21% tal-pazjenti kkurati b'Hycamtin (23 minn 112) irrispondew għattrattament, meta mqabbel ma' 14% tal-pazjenti kkurati b'paclitaxel (16 minn 114).
English: Hycamtin given as capsules was as effective as Hycamtin given as an infusion.
Maltese: Hycamtin mogħti bħala kapsuli kien effikaċi daqs Hycamtin mogħti bħala infużjoni.
English: It was as effective as the standard combination chemotherapy.
Maltese: kimoterapija standard.
English: Other information about Hycamtin
Maltese: Informazzjoni oħra dwar Hycamtin
English: The fourth study involved 226 women, and compared Hycamtin with paclitaxel (another cancer medicine).
Maltese: Ir-raba' studju involva 226 mara u qabbel Hycamtin ma' paclitaxel (mediċina oħra tal-kanċer).
English: When Hycamtin is used on its own for ovarian cancer, it is given by intravenous infusion over 30 minutes.
Maltese: Meta Hycamtin jintuża waħdu għall-kanċer tal-ovarji, jingħata permezz ta' infużjoni intravenuża fuq perjodu ta' 30 minuta.
English: Why has Hycamtin been approved?
Maltese: Għaliex ġie approvat Hycamtin?
English: A risk management plan has been developed to ensure that Hycamtin is used as safely as possible.
Maltese: Pjan ta' ġestjoni tar-riskju ġie żviluppat biex jiżgura li Hycamtin jintuża bl-aktar mod sigur possibbli.
English: What is Hycamtin?
Maltese: X'inhu Hycamtin?
English: For lung cancer, Hycamtin can be given as an infusion or, for adults, as capsules.
Maltese: Għall-kanċer tal-pulmun, Hycamtin jista' jingħata bħala infużjoni jew, f'każ ta' adulti, bħala kapsuli.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Hycamtin on 12 November 1996.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Hycamtin valida fl-Unjoni Ewropea kollha fl-It-Tlieta, 12 ta' Novembru 1996.
English: In lung cancer, looking at the results obtained in all three studies, the response rate was 20% (480 patients received Hycamtin).
Maltese: Fil-kanċer tal-pulmun, meta wieħed jeżamina r-riżultati miksuba fit-tliet studji kollha, ir-rata ta' rispons kienet 20% (480 pazjent ikkurati b' Hycamtin).
English: In cervical cancer, patients receiving the combination of Hycamtin and cisplatin survived an average of 9.4 months, compared with 6.5 months for the patients who received cisplatin only.
Maltese: Fil-kanċer taċ-ċerviċi, is-sopravivenza medja tal-pazjenti kkurati b'Hycamtin f'kombinazzjoni ma' ċisplatin kienet ta' 9.4 xhur meta mqabbel mas-6.5 xhur tal-pazjenti li kien ingħatalhom ċisplatin waħdu.
English: Hycamtin as an infusion has been studied in more than 480 women with ovarian cancer who had failed one treatment with platinum-containing cancer medicines.
Maltese: Hycamtin mogħti bħala infużjoni ġie studjat f'aktar minn 480 mara b' kanċer tal-ovarji li ma tkunx irnexxitilha l-kura bil-mediċini kontra l-kanċer li jkun fihom il-platinu.
English: What is the risk associated with Hycamtin?
Maltese: X'inhu r-riskju assoċjat ma' Hycamtin?
English: The CHMP decided that Hycamtin's benefits are greater than its risks and recommended that it be given marketing authorisation.
Maltese: Is-CHMP iddeċieda li l-benefiċċji ta' Hycamtin huma akbar mir-riskji tiegħu u rrakkomanda li jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: For the full list of all side effects and restrictions with Hycamtin, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u restrizzjonijiet kollha b'Hycamtin, ara l-fuljett ta' tagħrif.
English: How has Hycamtin been studied?
Maltese: Kif ġie studjat Hycamtin?
English: In ovarian cancer, the studies showed the effectiveness of Hycamtin, with an overall response rate of about 16%.
Maltese: Fil-kanċer tal-ovarji, l-istudji wrew l-effikaċja ta' Hycamtin, b'rata ta' rispons kumplessiva ta' madwar 16%.
English: It blocks an enzyme called topoisomerase I, which is involved in the division of DNA.
Maltese: Din timblokka enzima li tissejjaħ topojsomerażi I, li hija involuta fiddiviżjoni tad-DNA.
English: • metastatic cancer of the ovary (when the cancer has spread to other parts of the body).
Maltese: • kanċer tal-ovarji metastatiku (meta l-kanċer ikun infirex għal partijiet oħra tal-ġisem).