FrancophonIA/ELRC3.0 huggingface dataset:
English: Infusion-related reactions are characterised by one or more of the following symptoms: flushing, chills, pyrexia, dyspnoea, hypotension, wheezing, bronchospasm and tachycardia.
Maltese: Reazzjonijiet relatati mal-infużjoni huma kkaratterizzati minn wieħed jew aktar mis-sintomi li ġejjin: fwawar, sirdat, deni, qtugħ ta' nifs, pressjoni baxxa, tħarħir, bronkospażmu u takikardija.
English: Grade 4 (> 20 ´ ULN at any time)
Maltese: Grad 4 (> 20 × ULN fi kwalunkwe ħin)
English: Kadcyla (trastuzumab emtansine) is NOT a generic version of Herceptin (trastuzumab) and has different properties, indications and dose.
Maltese: MHUX verżjoni ġenerika ta' Herceptin (trastuzumab) u għandu kwalitajiet, indikazzjonijiet u doża differenti.
English: After reconstitution one vial of 5 mL solution contains 20 mg/mL of trastuzumab emtansine (see section 6.6).
Maltese: Wara r-rikostituzzjoni kunjett wieħed ta' soluzzjoni ta' 5 mL ikun fih 20 mg/mL ta' trastuzumab emtansine (ara sezzjoni 6.6).
English: The results of this descriptive follow-up analysis are consistent with the confirmatory OS analysis.
Maltese: Ir-riżultati ta' din l-analiżi deskrittiva ta' segwitu huma konsistenti mal-analiżi konfermattiva ta' OS.
English: If the LVEF remains < 50% and has not recovered to < 10% points from baseline, discontinue trastuzumab emtansine.
Maltese: Jekk l-LVEF jibqa' < 50% u ma jkunx irkupra għal < 10 punti % mil-linja bażi, waqqaf trastuzumab emtansine.
English: Kadcyla 100 mg powder for concentrate for solution for infusion One vial of powder for concentrate for solution for infusion contains 100 mg of trastuzumab emtansine.
Maltese: Kadcyla 100 mg trab għal konċentrat għal soluzzjoni għall-infużjoni.
English: Kadcyla 160 mg powder for concentrate for solution for infusion One vial of powder for concentrate for solution for infusion contains 160 mg of trastuzumab emtansine.
Maltese: Kadcyla 160 mg trab għal konċentrat għal soluzzjoni għall-infużjoni Kunjett wieħed ta' trab għal konċentrat għal soluzzjoni għall-infużjoni fih 160 mg ta' trastuzumab emtansine.
English: Patients should be clinically monitored on an ongoing basis for signs/symptoms of neurotoxicity.
Maltese: Il-pazjenti għandhom jiġu mmonitorjati klinikament fuq bażi kontinwa għal sinjali/sintomi ta' newrotossiċità.
English: NAME OF THE MEDICINAL PRODUCT Kadcyla 100 mg powder for concentrate for solution for infusion trastuzumab emtansine
Maltese: Kadcyla 100 mg trab għal konċentrat għal soluzzjoni għall-infużjoni
English: Standard cardiac function testing (echocardiogram or multigated acquisition (MUGA) scanning) should be performed prior to initiation of treatment and also at regular intervals (e.g. every three months) during treatment.
Maltese: Ittestjar standard tal-funzjoni kardijaka (ekokardjogramma jew skan multigated acquisition (MUGA)) għandu jsir qabel il-bidu tat-trattament u anke f'intervalli regolari (eż. kull tliet xhur) waqt ittrattament.
English: The majority of events were asymptomatic Grade 1 or 2 decrease in LVEF.
Maltese: Il-maġġoranza tal-avvenimenti kienu tnaqqis ta' Grad 1 jew 2 bla sintomi fl-LVEF.
English: · Trastuzumab emtansine, like trastuzumab, binds to domain IV of the HER2 extracellular domain
Maltese: ● Trastuzumab emtansine, bħal trastuzumab, jeħel mad-dominju IV tad-dominju ekstraċellulari (ECD - extracellular domain) ta' HER2, kif ukoll mar-riċetturi Fcγ u l-kompliment C1q.
English: NRH should be considered in all patients with clinical symptoms of portal hypertension and/or cirrhosis-like pattern seen on the computed tomography (CT) scan of the liver but with normal transaminases and no other manifestations of cirrhosis.
Maltese: NRH għandha tiġi kkunsidrata fil-pazjenti kollha b'sintomi kliniċi ta' pressjoni portali għolja u/jew disinn li jixbah ċirrożi osservat fuq skan ta' tomografija kompjuterizzata (CT - computed tomography) tal-fwied iżda bi transaminases normali u bl-ebda manifestazzjoni oħra ta' ċirrożi.
English: · Swirl the vial gently until completely dissolved.
Maltese: OS: sopravivenza globali;
English: In addition, developmental toxicity of maytansine has been identified in non-clinical studies which suggests that DM1, the microtubule-inhibiting cytotoxic maytansinoid component of trastuzumab emtansine, will be similarly teratogenic and potentially embryotoxic.
Maltese: Barra dan, tossiċità ta' maytansine fuq l-iżvilupp kienet identifikata fi studji mhux kliniċi li jissuġġerixxu li DM1, il-komponent maytansinoid ċitotossiku li jinibixxi l-mikrotubuli ta' trastuzumab emtansine, b'mod simili se jkun teratoġeniku u potenzjalment embrijotossiku.
English: Dry eye, Conjunctivitis, Vision blurred, Lacrimation increased
Maltese: Għajn tinħass xotta, Konġuntivite, Vista mċajpra, Żieda ta' dmugħ
English: Peripheral oedema, Chills
Maltese: Effetti sekondarji oħra jinkludu
English: Grade ≥ 2.
Maltese: 3% għal Grad ≥ 2.
English: STATEMENT OF ACTIVE SUBSTANCE(S) One vial of powder for concentrate for solution for infusion contains 100 mg of trastuzumab emtansine.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I) Kunjett wieħed ta' trab għal konċentrat għal soluzzjoni għall-infużjoni fih 160 mg ta' trastuzumab emtansine.
English: In the subgroup of patients with hormone receptor-positive disease (n=545), the hazard ratios for PFS and OS were 0.72 (95% CI: 0.58, 0.91) and 0.62 (95% CI: 0.46, 0.85), respectively.
Maltese: 72 (CI ta' 95%: 0.58, 0.91) u 0.62 (CI ta' 95%: 0.46, 0.85), rispettivament.
English: The decision to administer trastuzumab emtansine in MBC patients with low LVEF must be made only after careful benefit risk assessment and cardiac function should be closely monitored in these patients (see section 4.8).
Maltese: Id-deċiżjoni li jingħata trastuzumab emtansine f'pazjenti b'MBC b'LVEF baxx għandha ssir biss wara valutazzjoni bir-reqqa tal-benefiċċji u r-riskji, u l-funzjoni kardijaka għandha tiġi mmonitorjata mill-qrib f'dawn il-pazjenti (ara sezzjoni 4.8).
English: A cumulative effect on transaminases has also been observed (the proportion of patients with Grade 1-2 ALT/AST abnormalities increases with successive cycles).
Maltese: Kien osservat ukoll effett kumulattiv fuq transaminases (il-proporzjon ta' pazjenti b'anormalitajiet ta' Grad 1-2 fl-ALT/AST jiżdied b'ċikli suċċessivi).
English: · Tingling, pain, numbness, itching, crawling sensation, pins and needles in your hands and feet.
Maltese: ● Tingiż, uġigħ, tnemnim, ħakk, sensazzjoni ta' xi ħaġa miexja fuq il-ġilda, sensazzjoni ta' tingiż f'idejk u saqajk.
English: Hyperbilirubinemia Grade 2 (> 1.5 to ≤ 3´ the ULN)
Maltese: Grad 2 (> 1.5 sa ≤ 3 × l-ULN)
English: White to off-white lyophilised powder.
Maltese: Din l-anormalità tikkawża bidla fl-istruttura talfwied.
English: Trastuzumab emtansine has the mechanisms of action of both trastuzumab and DM1:
Maltese: ● kunjett ta' 100 mg trastuzumab emtansine:
English: The safety and efficacy in children and adolescents below 18 years of age have not been established as there is no relevant use in the paediatric population for the indication of breast cancer .
Maltese: Is-sigurtà u l-effikaċja fi tfal u adolexxenti b'età inqas minn 18-il sena ma ġewx determinati peress li m'hemm l-ebda użu rilevanti fil-popolazzjoni pedjatrika fl-indikazzjoni ta' kanċer tas-sider.
English: The MAH shall ensure that in parallel to the launch of Kadcyla (trastuzumab emtansine), all health care professionals who may prescribe, dispense or administer Kadcyla (trastuzumab emtansine) and/or Herceptin (trastuzumab) are provided with a health care professional (HCP) educational pack.
Maltese: L-MAH għandu jiżgura li fiż-żmien meta Kadcyla (trastuzumab emtansine) jitqiegħed fis-suq, ilprofessjonisti tal-kura tas-saħħa kollha li jistgħu jippreskrivu, jqassmu jew jagħtu Kadcyla (trastuzumab emtansine) u/jew Herceptin (trastuzumab) jingħataw pakkett edukattiv għallprofessjonist tal-kura tas-saħħa ( HCP - health care professional).
English: Ref.EMEA/313849/2009
Maltese: EMEA/519955/2009
English: The rapporteur and co-rapporteur appointed were: Dr Bruno Urbain and Dr Michael Holzhauser-Alberti, respectively.
Maltese: Bruno Urbain u d-Dott. Michael Holzhauser-Alberti, rispettivament.
English: OPINION FOLLOWING AN ARTICLE 33 (4)1 REFERRAL FOR FENFLOR 300 MG/ML SOLUTION FOR INJECTION FOR CATTLE International Non-Proprietary Name (INN): Florfenicol
Maltese: OPINJONI WARA REFERENZA SKONT L-ARTIKOLU 33(4)1 GĦAL FENFLOR 300 MG/ML SOLUZZJONI INJETTABBLI
English: The application was submitted in the framework of Article 32 of Directive 2001/82/EC, as amended, where the Reference Member State was the United Kingdom and the Concerned Member States were Austria, Belgium, France, Germany, Ireland, Italy, The Netherlands, Poland, Portugal and Spain.
Maltese: Id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq, Gosmore Ltd, ippreżenta applikazzjoni permezz tal-proċedura ta' rikonoxximent reċiproku għal Fenflor 300 mg/ml soluzzjoni injettabbli għall-bhejjem tal-ifrat, abbażi tal-awtorizzazzjoni għat-tqegħid fis-suq mogħtija mir-Renju Unit. Lapplikazzjoni ġiet ippreżentata fil-qafas tal-Artikolu 32 tad-Direttiva 2001/82/KE, kif emendata, li fih l-Istat Membru ta' Referenza kien ir-Renju Unit u l-Istati Membri Konċernati kienu l-Awstrija, ilBelġju, Franza, il-Ġermanja, l-Irlanda, l-Italja, l-Olanda, il-Polonja, il-Portugall u Spanja.
English: Due to concerns raised by Germany and The Netherlands during the Mutual Recognition Procedure that Fenflor 300 mg/ml solution for injection for cattle could present a potential serious risk to the environment, the United Kingdom referred the matter to the EMEA on 31 July 2008 under Article 33(4) of Directive 2001/82/EC.
Maltese: Minħabba xi tħassib, imqajjem mill-Ġermanja u mill-Olanda matul il-proċedura ta' rikonoxximent reċiproku, dwar il-fatt li Fenflor 300 mg/ml soluzzjoni injettabbli għall-bhejjem tal-ifrat seta' jippreżenta riskju potenzjali gravi għall-ambjent, ir-Renju Unit irrefera l-kwistjoni lill-EMEA fil-31 ta' Lulju 2008 skont l-Artikolu 33(4) tad-Direttiva 2001/82/KE.
English: The Marketing Authorisation Holder, Gosmore Ltd, submitted an application via mutual recognition for Fenflor 300 mg/ml solution for injection for cattle, on the basis of the marketing authorisation granted by the United Kingdom.
Maltese: Il-lista ta' ismijiet tal-prodott ikkonċernati hija mogħtija fl-Anness I.
English: Agrimony
Maltese: Agrimonju
English: Agrimony EMA/HMPC/332849/2015
Maltese: Agrimonju EMA/HMPC/332849/2015
English: Further information on the HMPC assessment of agrimony medicines, including details of the Committee's conclusions, can be found under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Maltese: Aktar informazzjoni dwar il-valutazzjoni tal-HMPC tal-mediċini tal-agrimonju, inklużi d-dettalji talkonklużjonijiet tal-Kumitat, tista' tinstab taħt it-tab "Id-dokumenti kollha" fis-sit elettroniku talAġenzija: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: What is agrimony?
Maltese: X'inhu l-agrimonju?
English: What are the risks associated with agrimony medicines?
Maltese: X'inhuma r-riskji assoċjati mal-mediċini tal-agrimonju?
English: Agrimony should only be used in adults and children over the age of 12 years.
Maltese: L-agrimonju għandu jintuża biss f'adulti u tfal ta' 'l fuq minn 12-il sena.
English: Other information about agrimony medicines
Maltese: Informazzjoni oħra dwar il-mediċini tal-agrimonju
English: For further information, see the HMPC assessment report.
Maltese: Għal aktar informazzjoni, ara r-rapport ta' valutazzjoni tal-HMPC.
English: Herbal medicines containing agrimony are usually available as herbal teas to be drunk, or as gargles.
Maltese: Mediċini erbali li fihom l-agrimonju normalment huma disponibbli bħala tejiet erbali biex jinxtorbu, jew għall-gargarizzar.
English: This means that, although there is insufficient evidence from clinical trials, the effectiveness of these herbal medicines is plausible and there is evidence that they have been used safely in this way for at least 30 years (including at least 15 years within the EU).
Maltese: Dan ifisser li, għalkemm m'hemmx biżżejjed evidenza minn provi kliniċi, l-effikaċja ta' dawn il-mediċini erbali hija plawsibbli u hemm evidenza li ilhom jintużaw b'dan il-mod sigur għal mill-anqas 30 sena (inkluż tal-anqas 15-il sena fl-UE).
English: The HMPC conclusions on the use of agrimony medicines for the relief of mild diarrhoea, mild inflammation of the mouth and throat, skin inflammation and wounds are based on their ‘traditional use' in these conditions.
Maltese: Il-konklużjonijiet tal-HMPC dwar l-użu ta' mediċini tal-agrimonju għas-serħan minn dijarea ħafifa, infjammazzjoni ħafifa tal-ħalq u l-griżmejn, infjamazzjoni tal-ġilda u ġrieħi huma abbażi tal-"użu tradizzjonali" tagħhom f'dawn il-kundizzjonijiet.
English: Agrimony can also be found in combination with other herbal substances in some herbal medicines.
Maltese: L-agrimonju jista' jinstab ukoll f'kombinazzjoni ma' sustanzi erbali oħra f'xi mediċini erbali.
English: The HMPC concluded that, on the basis of its long-standing use, agrimony can be taken by mouth for the relief of mild diarrhoea, or used as a gargle to relieve mild inflammation of the mouth and throat.
Maltese: Huma disponibbli wkoll bħala likwidi biex jiġu applikati fuq il-ġilda jew użati bħala addittivi għal mal-ilma tal-banju.
English: Further information on the risks associated with agrimony medicines, including the appropriate precautions for their safe use, can be found in the monograph under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Maltese: Aktar informazzjoni dwar ir-riskji assoċjati mal-mediċini tal-agrimonju, inklużi l-prekawzjonijiet xierqa għall-użu sigur tagħhom, tinstab fil-monografu taħt it-tab "Id-dokumenti kollha" fis-sit elettroniku talAġenzija:
English: Moreover, the intended uses do not require medical supervision.
Maltese: Barra minn hekk, l-użi maħsubin ma jeħtiġux superviżjoni medika.
English: This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of agrimony.
Maltese: Dan huwa sommarju tal-konklużjonijiet xjentifiċi li wasal għalihom il-Kumitat għall-Prodotti Mediċinali Erbali (HMPC) dwar l-użi mediċinali tal-agrimonju.
English: The HMPC noted the lack of clinical studies with agrimony, but took into account the well documented use of this herbal medicine for the above uses.
Maltese: L-HMPC innota n-nuqqas ta' studji kliniċi b'agrimonju, iżda kkunsidra l-użu dokumentat sew ta' din ilmediċina erbali għall-użi msemmijin hawn fuq.
English: What evidence supports the use of agrimony medicines?
Maltese: X'evidenza tappoġġa l-użu tal-mediċini tal-agrimonju?
English: Any applications for the licensing of medicines containing agrimony have to be submitted to the national authorities responsible for medicinal products, which will assess the application for the herbal medicine and take into account the scientific conclusions of the HMPC.
Maltese: Kwalunkwe applikazzjoni għal-liċenzjar ta' mediċini li fihom l-agrimonju għandha titressaq lillawtoritajiet nazzjonali responsabbli għall-prodotti mediċinali, li ser jivvalutaw l-applikazzjoni għallmediċina erbali u jqisu l-konklużjonijiet xjentifiċi tal-HMPC.
English: Toviaz fesoterodine
Maltese: Toviaz fesoterodina
English: The full EPAR for Toviaz 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 reductions seen in patients taking placebo and tolterodine were 1.02 and 1.69, respectively.
Maltese: It-tnaqqis li deher f'pazjenti li ħadu l-plaċebo u t-tolterodina kien 1.02 u 1.69 rispettivament.
English: This number was reduced by 1.74 and 1.86 with the 4 mg dose of Toviaz and by 1.94 with the 8 mg dose.
Maltese: Dan in-numru tnaqqas b'1.74 u b'1.86 bid-doża ta' 4 mg ta' Toviaz u b'1.94 bid-doża ta' 8 mg.
English: Toviaz is a medicine containing the active substance fesoterodine.
Maltese: Toviaz huwa mediċina li fiha s-sustanza attiva fesoterodina.
English: This is a summary of the European public assessment report (EPAR) for Toviaz.
Maltese: Dan huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Toviaz.
English: These include medicines such as ketoconazole and itraconazole (used to treat fungal infections), atazanavir, indinavir, nelfinavir, ritonavir and saquinavir (medicines used in HIV-positive patients), clarithromycin and telithromycin (antibiotics), and nefazodone (used to treat depression).
Maltese: Dawn jinkludu mediċini bħall-ketokonażolu u l-itrakonażolu (użati għall-kura ta' infezzjonijiet fungali), l-atażanavir, l-indinavir, in-nelfinavir, ir ritonavir u s-sakwinavir (mediċini użati fuq pazjenti bl-HIV), il-klaritromiċina u t-telitromiċina (antibijotiċi), u n-nefażodonu (użata għall-kura tad-depressjoni).
English: The active substance in Toviaz, fesoterodine, is an anticholinergic medicine.
Maltese: Is-sustanza attiva f'Toviaz, il-fesoterodina, hija mediċina antikolinerġika.
English: Why has Toviaz been approved?
Maltese: Għaliex ġie approvat Toviaz?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Toviaz on 20 April 2007.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Toviaz valida fl-Unjoni Ewropea kollha fl-20 ta' April 2007.
English: The two main studies involved 1,964 patients with overactive bladder syndrome and compared Toviaz (4 or 8 mg a day) with placebo (a dummy treatment).
Maltese: Iż-żewġ studji ewlenin saru fuq 1,964 pazjent bis-sindromu tal-bużżieqa tal-awrina iperattiva u qabblu lil Toviaz (4 jew 8 mg kuljum) ma' plaċebo (trattament finta).
English: The recommended starting dose of Toviaz is 4 mg once a day.
Maltese: Id-doża inizjali rakkomandata ta' Toviaz hija 4 mg darba kuljum.
English: It is available as prolonged-release 4 mg tablets and 8 mg tablets.
Maltese: Jiġi f'pilloli b'rilaxx fit-tul ta‘ 4 mg u 8 mg.
English: • severe ulcerative colitis (severe inflammation of the large intestine causing ulceration and bleeding);
Maltese: • kolite ulċerattiva gravi (infjammazzjoni gravi fil-musrana l-kbira li tikkawża ulċeri u fsada);
English: Toviaz must not be given to patients with moderate liver or moderate to severe kidney disease at the same time as strong CYP3A4 inhibitor medicines.
Maltese: Toviaz m'għandux jingħata lill-pazjenti b'mard moderat fil-fwied jew b'mard moderat sa gravi fil-kliewi fl-istess ħin li jingħataw mediċini inibituri CYP3A4 qawwija.
English: What is Toviaz?
Maltese: X'inhu Toviaz?
English: One of the studies also compared Toviaz with tolterodine (another medicine used in overactive bladder syndrome).
Maltese: Wieħed mill-istudji qabbel ukoll lil Toviaz mat-tolterodina (mediċina oħra użata kontra s-sindrome tal-bużżieqa tal-awrina iperattiva).
English: • myasthenia gravis (a disease of the nerves causing muscle weakness);
Maltese: • mijastenija gravi (marda fin-nervituri li tikkawża dgħajfien fil-muskoli);
English: The dose of Toviaz must be adjusted, or the medicine not used at all, in patients with problems with their kidneys or liver, depending on whether they are also receiving ‘CYP3A4 inhibitors', a group of medicines that may affect the way Toviaz is broken down in the body.
Maltese: F'pazjenti li jkollhom problemi fil-kliewi jew fil-fwied, id-doża ta' Toviaz għandha tiġi aġġustata, jew saħansitra ma titteħidx, jekk ikunu qed jingħataw l-‘inibituri CYP3A4' ukoll, grupp ta' mediċini li jistgħu jaffettwaw il-mod kif Toviaz jitkisser fil-ġisem.
English: Toviaz is used in adults with overactive bladder syndrome to treat the symptoms of the disease: increased urinary frequency (need to urinate frequently), urgency (sudden urge to pass urine), and urgency incontinence (sudden lack of control over urination).
Maltese: Toviaz jintuża fuq adulti bis-sindromu tal-bużżieqa tal-awrina iperattiva biex jiġu kkurati s-sintomi talmarda: żieda fil-frekwenza tal-awrina (bżonn urġenti li tagħmel l-awrina), urġenza (xewqa għal għarrieda li tagħmel l-awrina) u inkontinenza tal-urġenza (nuqqas ta' kontroll għal għarrieda fuq lgħamil tal-awrina).
English: What is the risk associated with Toviaz?
Maltese: X'inhu r-riskju assoċjat ma' Toviaz?
English: How has Toviaz been studied?
Maltese: Kif ġie studjat Toviaz?
English: The main measure of effectiveness was the change in the number of times the patients needed to urinate in a 24-hour period after 12 weeks of treatment.
Maltese: Toviaz kien aktar effikaċi mill-plaċebo u effikaċi daqs it-tolterodina fit-tnaqqis tal-għadd ta' drabi li lpazjenti għamlu l-awrina tul perjodu ta' 24 siegħa.
English: The CHMP decided that Toviaz's benefits are greater than its risks and recommended that it be given marketing authorisation.
Maltese: Is-CHMP iddeċieda li l-benefiċċji ta' Toviaz huma akbar mir-riskji tiegħu u għaldaqstant irrakkomanda li jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: • Information that in patients with mutant KRAS tumours panitumumab has shown a detrimental effect in combination with FOLFOX and no effect as monotherapy and in combination with FOLFIRI
Maltese: KRAS mutant panitumumab wera effett detrimentali flimkien ma' FOLFOX u ma wera l-ebda effett bħala monoterapija u flimkien ma' FOLFIRI
English: • Recommendation that Vectibix: o should only be used in patients whose tumours are wild-type KRAS o should not be used as monotherapy or in combination with FOLFIRI in patients whose tumours are mutant KRAS or patients whose tumours have not been tested for KRAS status o is contraindicated in combination with FOLFOX in patients with mutant KRAS tumours or in patients with unknown KRAS tumour status
Maltese: Id-Detentur tal-Awtorizzazzjoni għat-tqegħid fis-suq se jiżgura li it-tobba kollha li mistennija jippreskrivu Vectibix huma pprovduti b'materjal edukattivi li jinfurmhom bl-importanza li jiġi żgurat l-istat ta' KRAS qabel kura b'panitumumab.
English: The Marketing Authorisation Holder shall agree the format and content of the above materials with the National Competent Authority of each Member State.
Maltese: Id-Detentur tal-Awtorizzazzjoni għat-tqegħid fis-suq għandu jiftiehem dwar id-disinn u lkontenut tal-materjal imsemmi fuq mal-Awtorità Kompetenti Nazzjonali ta' kull Stat Membru.
English: • Brief introduction to KRAS and its role in the panitumumab mechanism of action
Maltese: • Introduzzjoni qasira għal KRAS u r-rwol tiegħu fil-mekkaniżmu ta' azzjoni ta'
English: • Brief introduction to the Vectibix indication and the purpose of this tool
Maltese: • Introduzzjoni qasira għall-indikazzjoni ta' Vectibix u l-iskop ta' din l-għodda
English: • Information on how the KRAS testing should be appropriately conducted
Maltese: • Informazzjoni li f'pazjenti b'tumuri bi
English: (in EEA)
Maltese: EU/EEA
English: QUIXIL solution for sealant
Maltese: QUIXIL soluzzjoni ta' siġillant
English: 1640 Rhode-St-Genèse Belgium
Maltese: Rhode-St-Genese Il-Belġju
English: Fibronectin, human: 30 mg Human fibrinogen: 30 mg Arginine hydrochloride 19 mg Acidum tranexamicum 95 mg Glycine 7,9 mg Sodium chloride 7 mg
Maltese: Fibronektina, umana: 30 mg Fibrinoġen, uman: 30 mg Arginine hydrochloride: 19 mg Acidum tranexamicum:
English: Omrix Biopharmaceuticals S.A., Chaussee de Waterloo 200, B-1640 Rhode-St-Genese Belgium
Maltese: Omrix Biopharmaceuticals S.A., Chaussee de Waterloo 200, B-1640
English: Solution for sealant Intralesional use
Maltese: Id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq
English: Tranexamic acid 85 mg/ml -105mg /ml 2nd Component (Thrombin) Thrombin 800 IU /ml - 1200 IU /ml Calcium chloride: 5,6 mg/ml - 6,2 mg /ml
Maltese: L-Ewwel Komponent (BAC) Fibrinoġen-Fibronektina: 40 mg/ml-60 mg/ml Tranexamic acid: 85 mg/ml-105 mg/ml It-Tieni Komponent (Thrombin) Thrombin 800 IU/ml-1200 IU/ml Klorur tal-Kalċju 5.6 mg/ml-6.2 mg/ml
English: Clottable protein conc: 50mg/ml Thrombin: 1000 IU/ml Calcium chloride: 5.9 mg/ml Tranexamic acid: 95mg/ml
Maltese: Konċentrat ta' proteina li tagħqad: 50 mg/ml Thrombin: 1000 IU/ml Klorur tal-Kalċju: 5.9 mg/ml Transexamic acid: