FrancophonIA/ELRC3.0 huggingface dataset:
English: The terminal half-life at the maximum tolerated intravenous dose (150 µg/m2) was 15-30 min.
Maltese: Il-half life meta tingħata d-doża massima tollerata mill-ġisem fil-vina (150 µg/m2) kienet bejn 15 u 30-il minuta.
English: Significant hepatic dysfunction, e.g. > 2 x upper limits of normal levels of aspartate aminotransferase, alanine aminotransferase or alkaline phosphatase; or bilirubin levels > 1.25 x upper limits of normal.
Maltese: Funzjoni ħażina tal-fwied sinifikanti, e.g. > 2 x limitu ta' fuq tal-livelli normali ta' aspartate aminotransferase, alanine aminotransferejs jew alkalajn fosfatejs; jew livelli ta' bilirubin ta > 1.25 x limiti massimi normali.
English: *tumor necrosis factor alfa-1a (TNFα-1a) produced by recombinant DNA technology in E. coli.
Maltese: *fattur tan-nekrosi tat-tumur alfa-1a (TNFα-1a) magħmul minn teknoloġija tad-DNA rikombinanti fi E. coli.
English: Infection, wound infection
Maltese: Infezzjoni, infezzjoni tal-feriti
English: Significant haematological dysfunction, e.g. leucocytes < 2.5 x 109/l, haemoglobin < 9 g/dl, platelets < 60 x 109/l, haemorrhagic diathesis or active bleeding disorder.
Maltese: Funzjoni ħażina ematoloġika sinifikanti, eż. lewkoċiti < 2.5 x 109/l, emoglobina < 9 g/dl, plejtlets < 60 x 109/l, dijastażi emorraġika jew problemi ta' fsada attiva.
English: Each vial contains 20.12 mg (0.87 mmol) sodium.
Maltese: 12 mg (0.87 mmol) ta' sodium.
English: Treatment with anti-TNFα antibodies is not recommended.
Maltese: Mhux rakkomandat trattament b'anti-korpi anti-TNFα.
English: Each vial contains 1 mg tasonermin*, corresponding to 3.0-6.0 x 107 IU (International Units).
Maltese: Kull kunjett fih 1 mg ta' tasonermin*, li jikkorrispondi għal 3.0-6.0 x 107 IU (Unitajiet Internazzjonali).
English: Sodium dihydrogen phosphate dihydrate, disodium phosphate dodecahydrate, human serum albumin
Maltese: Sodium dihydrogen phosphate dihydrate, disodium phosphate dodecahydrate, u albumina tas-serum tal-bniedem
English: After reconstitution in 0.9 % physiological sodium chloride solution the amount is 37.82 mg (1.64 mmol) sodium.
Maltese: Wara r-rikostituzzjoni f'soluzzjoni fiżjoloġika ta' 0.9% sodium chloride, l-ammont ikun ta' 37.82 mg (1.64 mmol) ta' sodium.
English: Each vial contains 1 mg tasonermin, corresponding to 3.0-6.0 x 107 IU.
Maltese: Kull kunjett fih 1 mg ta' tasonermin, li jikkorrispondi għal 3.0-6.0 x 107 IU.
English: Beromun contains sodium
Maltese: Beromun fih sodium
English: Adult respiratory distress syndrome
Maltese: Sindromu ta' disturb respiratorju f'adulti
English: The container contains latex rubber
Maltese: Il-kontenitur fih lastku tal-latex
English: Each vial contains 1 mg tasonermin.
Maltese: Kull kunjett fih 1 mg ta' tasonermin.
English: The content of one vial of Beromun powder should be reconstituted with 5.3 ml sterile 0.9% sodium chloride solution for injection - The other ingredients (excipient(s)) are sodium dihydrogen phosphate dihydrate, disodium phosphate dodecahydrate and human serum albumin.
Maltese: Il-kontenut ta' kunjett wieħed ta' trab Beromun għandu jiġi rikostitwit b'5.3 ml ta' soluzzjoni għall-injezzjoni sterili ta' 0.9% sodium chloride - Is-sustanzi mhux attivi l-oħra (eċċipjent(i)) huma sodium dihydrogen phosphate dihydrate, disodium phosphate dodecahydrate u albumina tas-serum uman.
English: Boehringer Ingelheim RCV GmbH & Co KG Dr. Boehringer Gasse 5-11
Maltese: Boehringer Ingelheim RCV GmbH & Co
English: Indirect and direct immunomodulation: Tasonermin has profound effects on cellular components of the immune system.
Maltese: Immunomodulazzjoni indiretta u diretta: Tasonermin għandu effett profond fuq il-komponenti ċellulari tas-sistema immunitarja.
English: Each pack contains 4 vials.
Maltese: Kull pakkett fih 4 kunjetti.
English: The reconstituted medicinal product contains up to 151.27 mg (6.58 mmol) sodium per recommended dose.
Maltese: Il-prodott mediċinali rikostitwit fih sa 151.27 mg (jew 6.58 mmol) ta' sodium f'kull doża rakkomandata.
English: The maximum tolerated dose (MTD) of tasonermin for ILP is 4 mg, which is 10 times the systemic MTD.
Maltese: Id-doża massima tollerata (MTD) ta' tasonermin għall-ILP hija ta 4 mg, li hija 10 darbiet dik tad-doża sistemika.
English: After that, melphalan will be added and the ILP continued for another 60 minutes.
Maltese: Wara dan, melphalan ser jiżdied u l-ILP titkompla għal 60 minuta oħra.
English: Sodium dihydrogen phosphate dihydrate Disodium phosphate dodecahydrate Human serum albumin.
Maltese: Sodium dihydrogen phosphate dihydrate Disodium phosphate dodecahydrate Albumina tas-serum tal-bniedem
English: Melphalan dose should be calculated according to the litre-volume method of Wieberdink (Wieberdink J, Benckhuysen C, Braat RP, van Slooten EA, Olthius GAA.
Maltese: (Wieberdink J, Benckhuysen C, Braat RP, van Slooten EA, Olthius GAA.
English: Skin necrosis, oedema peripheral
Maltese: Nekrosi tal-ġilda, edema periferali
English: Venous thrombosis, arterial thrombosis, shock, hypotension
Maltese: Trombożi venuża, trombożi arterjali, xokk, pressjoni baxxa
English: Under conditions of less than 2% systemic leakage (observed in 38 of 51 patients), maximum systemic circulation concentrations of tasonermin were reached 5 min after the start of ILP and are approximately 200 times less than in the perfusion circuit.
Maltese: Taħt kundizzjonijiet fejn it-tnixxija sistemika hija ta' anqas minn 2% (dan ġie osservat f'38 mill-51 pazjent), il-konċentrazzjoni massima ta' tasonermin fiċ-ċirkolazzjoni sistemika intlaħqet wara 5 minuti mill-bidu tal-proċedura ta' l-ILP u kienet bejn wieħed u ieħor 200 darba iktar baxxa minn dik taċ-ċirkwit tal-perfużjoni.
English: Significant cardiovascular disease, e.g. congestive heart failure (New York Heart Association Class II, III or IV), severe angina pectoris, cardiac arrhythmias, myocardial infarction within a 3 months period prior to treatment, venous thrombosis, occlusive peripheral arterial disease, recent pulmonary embolism.
Maltese: II, III jew IV), anġina pectoris gravi, arritmji kardijaċi, infart majokardijaku li jkun seħħ f'3 xhur jew anqas, qabel it-trattament, trombożi tal-vini, arterji periferjali misdudin, emboliżmu pulmonari riċenti.
English: Onychomadesis (loss of nails) Musculoskeletal and connective tissue disorders Common:
Maltese: Onikomadesi (telf ta' dwiefer) Disturbi muskolu-skeletriċi u tat-tessuti konnettivi Komuni:
English: Data obtained from 51 ILP patients demonstrated maximum concentrations of tasonermin in the perfusion circuit are reached 30 min after the onset of ILP and range between 3000 and 4000 ng/ml.
Maltese: Informazzjoni miġbura minn 51 pazjent li ngħataw il-proċedura ta' l-ILP, deher li d-doża massima ta' tasonermin li ntlaħqet fiċ-ċirkwit tal-perfużjoni wara 30 minuta mill-bidu tal-proċedura ILP kien ta' bejn 3,000 u 4,000 ng/ml.
English: The reason for the differential sensitivity of the tumour vasculature (high) versus normal vasculature (low) are currently unknown.
Maltese: Ir-raġuni għas sensittività differenzjali tal-vaskulatura tat-tumur (għolja) kontra l-vaskulatura normali (baxxa)
English: Contraindications to Beromun ILP, subdivided by components of the procedure, are: Contraindications to Beromun:
Maltese: Kontraindikazzjonijiet għal ILP b'Beromun, imqassma skond il-komponenti differenti tal-proċedura huma:
English: The content of one vial of Beromun powder should be reconstituted with 5.3 ml sterile 0.9% sodium chloride solution for injection.
Maltese: Il-kontenut ta' kunjett wieħed ta' trab Beromun għandu jiġi rikostitwit b'5.3 ml ta' soluzzjoni għallinjezzjoni sterili ta' 0.9% sodium chloride.
English: Pharmacotherapeutic group: Other immunostimulants, ATC code: L03AX11
Maltese: Immunostimulanti oħra, Kodiċi ATC:
English: Beromun contains the active substance tasonermin (tumor necrosis factor alfa-1a), produced by recombinant DNA technology.
Maltese: Beromun fih is-sustanza attiva tasonermin (fattur tan-nekrosi tat-tumur alfa-1a), magħmula minn teknoloġija tad-DNA rikombinanti.
English: In order to minimise the risk of leakage of the perfusate into the systemic circulation, the perfusion flow rate should not exceed 40 ml/litre limb volume/minute.
Maltese: Biex jitnaqqas ir-riskju tat-tnixxija tal-likwidu ta' perfużjoni fiċ-ċirkolazzjoni sistemika, ir-rata ta' l influss ta'perfużjoni m'għandhiex taqbeż l-40 ml/litru volum tad-driegħ-riġel/minuta.
English: The container of this medicinal product contains latex rubber.
Maltese: Il-kontenitur ta' dan il-prodott mediċinali fih il-lastku latex.
English: Direct effects on tumour vasculature: Tasonermin affects the morphology and reduces proliferation of endothelial cells and modifies expression of specific cell surface and secretory proteins (including adhesion molecules and proteins modulating coagulation, interleukins and haematopoietic growth factors).
Maltese: Tasonermin jaffettwa l-morfoloġija u jnaqqas il proliferazzjoni ta' ċelluli endoteljali u jibdel l-espressjoni tal-wiċċ speċifiku taċ-ċelluli u l-proteini li jnixxu (li jinkludu adeżjoni tal-molekuli u koagulazzjoni modulating tal-proteini, interleukins u fatturi tat-tkabbir ematopojetiku).
English: How to store Beromun
Maltese: Tużax Beromun
English: Beromun is contraindicated in pregnancy (see section 4.3).
Maltese: Beromun hu kontra-indikat waqt it-tqala (ara 4.3).
English: After connection of the limb to the isolated circuit, flow rate should be adjusted to 35 to 40 ml/litre limb volume/minute and leakage from limb to systemic circulation checked using a radioactive tracer technique (see section 4.4).
Maltese: Wara li d-driegħ/riġel jiġi mqabbad maċ-ċirkwit iżolat, ir-rata ta' l-influss għandha tiġi aġġustata għal 35 sa 40 ml/volum f'litri fid-driegħ-riġel / minuta u t-tnixxija mid-driegħ/riġel għaċ-ċirkolazzjoni sistemika għandha tiġi ċċekkjata permezz ta' teknika li titraċċa ir-radjoattività (ara sezzjoni 4.4).
English: The duration of the perfusion including melphalan should be 60 minutes.
Maltese: It-tul ta' żmien tal-perfużjoni li tinkludi melphalan għandu jkun ta' 60 minuta.
English: Beromun will be administered by a doctor who is experienced and skilled in isolated limb perfusion (ILP).
Maltese: Beromun ser jingħata minn tabib li jkollu esperjenza u kompetenza f'isolated limb perfusion (ILP).
English: Beromun 1 mg powder for infusion Tasonermin
Maltese: Beromun 1 mg trab għal soluzzjoni għall-infużjoni
English: The perfusion circuit (roller pump, oxygenator with integrated reservoir, heat exchanger, connecting tubing) should be prepared prior to surgery and primed with 700 to 800 ml of perfusate, with haematocrit of 0.25 to 0.30.
Maltese: Iċ-ċirkwit tal-perfużjoni (roller pump, ossiġinatur bir-riżervwar integrat, tagħmir li jitrasferixxi minn medju għal ieħor, tubi ta' konnessjoni) għandu jitlesta qabel il-kirurġija u għandu l-ewwel jiġi pprajmjat b'700 jew 800 ml ta' likwidu ta' perfużjoni, b'ematokrit ta' 0.25 sa 0.30.
English: Systemic adverse reactions include mild constitutional reactions and toxic effects on different organ systems.
Maltese: Reazzjonijiet avversi sistemiċi jinkludu reazzjonijiet kostituzzjonali ħfief u effetti tossiċi fuq sistemi differenti ta' organi.
English: Once the temperature in the distal subcutaneous tissue of the limb has reached >38°C, (but not exceeding 39°C), and pH of the perfusate is between 7.2 and 7.35, Beromun should be injected as a bolus into the arterial line of the circuit.
Maltese: Ġaladarba t-temperatura fit-tessut distali taħt il-ġilda tar-riġel/driegħ tilħaq >38°C, (iżda ma taqbiżx 39°C), u l-pH tal-likwidu tal-perfużjoni jkun bejn 7.2 u 7.35, Beromun għandu jiġi injettat bħala bolus ġol-linja arterjali taċ-ċirkuwitu.
English: Clinical data however indicate that the overall incidence of adverse events is increased if patients are simultaneously exposed to tasonermin and interferon-gamma.
Maltese: Informazzjoni klinika wriet li linċidenza ta' effetti mhux mixtieqa żdiedet f'pazjenti li ngħataw fl-istess ħin tasonermin u interferon gamma.
English: Sepsis Blood and lymphatic system disorders Common:
Maltese: Sepsis Disturbi tad-demm u tas-sistema limfatika Komuni:
English: There is no specific antidote for tasonermin currently available.
Maltese: Attwalment, ma jeżisti l-ebda antidotu ta' tasonermin disponibbli.
English: These include standard anaesthetic agents, analgesics, antipyretics, intravenous fluids, anticoagulants and vasopressor agents.
Maltese: Dawn jinkludu l-użu ta' loppju standard, analġeżiċi, anti-pajretiċi, fluwidi li jingħataw ġol-vina, anti-koagulanti u aġenti vażopressuri standard.
English: Reconstituted solution Chemical and physical in-use stability has been demonstrated for up to 48 hours at 25°C.
Maltese: Intwera li s-soluzzjoni hi stabbli kimikament kif ukoll fiżikament jekk tinżamm għal 48 siegħa f'temperatura ta' 25°C
English: In the Rhesus monkey, pharmacokinetic studies following intravenous injection of tasonermin indicated a non-specific, non-saturable excretion via glomerular filtration in the kidney.
Maltese: Studji farmakokinetiċi fix-xadina Rhesus, wara li ngħataw injezzjoni ġol-vina ta' tasonermin, indikaw eliminazzjoni permezz ta' filtrazzjoni glomerulari li mhiex saturata u mhiex speċifika.
English: Tasonermin has been shown to be active in the classic assay for tumour necrosis factor, producing haemorrhagic necrosis of tumour nodules in murine syngeneic and human xenogeneic tumour systems after local or systemic injection.
Maltese: Intwera li tasonermin hu attiv fl-assaġġ klassiku għall-fattur tan-nekrosi tat-tumur, u li jipproduċi nekrosi emorraġika ta' għoqod tat-tumur f'sistemi tat-tumur murine syngeneic u umani xenogeneic wara injezzjoni lokali jew sistemika.
English: There is no evidence that any of these agents counteracts the pharmacodynamic effects of tasonermin.
Maltese: M'hemm l-ebda evidenza li xi waħda minn dawn is-sustanzi taħdem kontra l-effetti farmakodinamiċi ta' tasonermin.
English: Significant renal dysfunction, e.g. nephrotic syndrome, serum creatinine > 150 µmol/l, or creatinine clearance of < 50 ml/min.
Maltese: > 150 µmol/l, jew ir-rata li biha titneħħa l-kreatinina ta' < 50 ml/minute.
English: EXP
Maltese: ILP.
English: Beromun must not be administered systemically.
Maltese: Beromun m'għandux jingħata b'mod sistematiku.
English: This will occur whilst you are unconscious, under the influence of a general anaesthetic.
Maltese: Dan ser iseħħ waqt li inti ma tkunx f'sensik, taħt l-effett ta' anestetiku ġenerali.
English: Proliferation of activated B- and T-lymphocytes, development of cytotoxic T-cells and immunoglobulin-secreting cells is enhanced, monocytes/macrophages are activated for killing of tumour cells, granulocytes are activated to display enhanced phagocytic activity, respiratory burst and degranulation, and adherence to endothelium.
Maltese: Tiġi mgħaġġla aktar il-proliferazzjoni tal-limfoċiti-B u -T attivati, jiżviluppaw iċ-ċelluli T li huma ċitotossiċi, u l-għadd ta' ċelluli li jnixxu l-immunoglobulini jiżdied, ilmonoċiti/makrofaġi jiġu attivati biex joqtlu iċ-ċelluli tat-tumur, il-granuloċiti jiġu attivati u juru attività fagoċitika ikbar, ikollhom żieda kbira fir-rata respiratorja f'daqqa (respiratory burst) u degranulazzjoni u jeħlu aktar ma' l-endotilju.
English: Induction of general anaesthesia and subsequent mechanical ventilation should be applied according to standard methods.
Maltese: Induzzjoni ta' loppju ġenerali u l-ventilazzjoni mekkanizzata għandha tiġi applikata skond il-metodi standard.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal
Maltese: Artikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikat fuq il portal elettroniku Ewropew tal-mediċini.
English: Adjustment of flow rate and tourniquet may be required to ensure leakage from perfusion circuit to systemic circulation is stable (systemic level of radioactivity has reached a plateau) and does not exceed 10 %.
Maltese: perfużjoni u tat-turnikett biex ikun aċċertat li t-tnixxija hija stabbli (livell sistemiku ta' radjoattività ikun stabbli) u ma jaqbiżx l-10%.
English: Side effects may be caused by Beromun, melphalan, the ILP technique or a combination of these factors.
Maltese: L-effetti sekondarji jistgħu jiġu kkawżati minn Beromun, melphalan, it-teknika ILP teknika jew kumbinazzjoni ta' dawn il-fatturi.
English: Several lines of evidence suggest that these immunomodulatory activities are of relevance for the antitumour effects; e.g. the antitumour activities of tasonermin are much less pronounced in immunodeficient animals.
Maltese: Diversi fatturi juru li din l-attività immunomodulatorja hija relevanti għall-effetti kontra t-tumur eż. effett kontra t-tumur ta' tasonermin huma ħafna inqas f'annimali li huma immunodefiċjenti.
English: The most frequent adverse reactions reported in clinical trials were fever, nausea, vomiting, fatigue, arrhythmia, chills, pain, wound infection and skin reaction.
Maltese: L-iktar reazzjonijiet avversi frekwenti rrappurtati fil-provi kliniċi kienu deni, nawseja, rimettar, għeja kbira, arritmija, tertir ta' bard, uġigħ, infezzjoni tal-feriti u reazzjonijiet tal-ġilda.
English: Beromun will be administered by isolated limb perfusion (ILP), together with the anti-tumour agent melphalan.
Maltese: Beromun ser jingħata permezz ta' isolated limb perfusion (ILP), flimkien ma' sustanza kontra t-tumur melphalan.
English: Severe pulmonary dysfunction.
Maltese: Funzjoni ħażina severa tal-pulmuni.
English: ), to a maximum dose of 150 mg. 13 mg/l perfused upper limb volume
Maltese: 13 mg/l permezz ta' volum ta' perfużjoni fid-driegħ 10 mg/l permezz ta' volum ta' perfużjoni fir-riġel
English: No evidence has been found of any mutagenic effect, neither in vivo nor in vitro.
Maltese: Ma nstab li hemm l-ebda evidenza li turi xi mutaġeneżi, kemm in vivo kif ukoll in vitro.
English: Adverse reactions have been ranked under headings of frequency using the following convention:
Maltese: Disturbi ġenerali u kondizzjonijiet ta' mnejn jingħata Komuni ħafna:
English: Arrhythmia
Maltese: Pożoloġija
English: If you get any side effects talk to your doctor.
Maltese: Ma twettaq l-ebda studju ta' interazzjoni.
English: Under conditions of greater than 2 % systemic leakage (observed in 13 of 51 patients) maximum systemic concentrations of tasonermin were still at least ten times lower than in the perfusion circuit.
Maltese: Taħt kundizzjonijiet fejn ittnixxija ta' tasonermin fiċ-ċirkolazzjoni sistemika kien iktar minn 2% (dan ġie osservat f'21 mill 51 pazjent), il-konċentrazzjonijiet fiċ-ċirkolazzjoni massima ta' tasonermin kienu dejjem mill-inqas 10 darbiet inqas minn dik fiċ-ċirkwit tal-perfużjoni.
English: Hepatotoxicity
Maltese: L-Awstrija
English: Because of the unknown risk to the infant, breast-feeding is contraindicated within 7 days of ILP (see section 4.3).
Maltese: Minħabba li r-riskju fuq it-tarbija mhux maħruf, it-treddiegħ huwa kontra-indikat sa 7 ijiem wara l-proċedura ta' l-ILP (ara
English: The powder is white to off-white.
Maltese: It-trab huwa ta' lewn bajdani għal off-white.
English: Common (may affect up to 1 in 10 people) - infections local wound infections reductions in numbers of certain white blood cells and platelets hypersensitivity (allergic) reactions nerve damage decreased consciouness headache heart problems which can cause shortness of breath or ankle swelling blood clot formation in the artery or vein of the affected arm or leg (thrombosis) - low blood pressure, shock - severe breathing problems - constipation, diarrhoea skin necrosis (death of skin cells) in the affected arm or leg swelling of the ankles, feet or fingers caused by fluid build up in the affected arm or leg “compartment syndrome”, a medical condition characterised by pain, swelling and neurological symptoms, as well as muscle damage in the affected arm or leg muscle pain - protein in urine night sweats tissue necrosis (death of tissue cells) in the affected arm or leg, which is severe enough to require amputation
Maltese: - nekrosi tal-ġilda (il-mewt taċ-ċelluli tal-ġilda) fid-driegħ jew riġel affettwati - nefħa tal-għekiesi, saqajn jew swaba' kkawżata minn akkumulazzjoni ta' fluwidu fid-driegħ jew fir-riġel affettwati - “sindrome tal-kompartiment”, kundizzjoni medika kkaratterizzata minn uġigħ, nefħa u sintomi newroloġiċi, kif ukoll ħsara fil-muskoli fid-driegħ jew tar-riġel affettwati
English: Nausea, vomiting
Maltese: - stitikezza, dijarea
English: Perfusion level should be chosen to adequately encompass affected tissue (external iliac, common femoral, femoro-popliteal, popliteal, axillary and brachial being accepted routes) and catheters introduced.
Maltese: Il-livell ta' perfużjoni għandu jintgħażel b'tali mod li jkun biżżejjed biex jiċċirkola b'mod xieraq mat tessuti milquta (l-ilju estern, il-wirk komuni (common femoral), fieragħ-wirk (femoro-popliteal), ilfieragħ (popliteal), l-abt u d-driegħ (axillary and brachial) komuni huma l-passaġġi aċettati) u l kateters introdotti.
English: GENERAL CLASSIFICATION FOR SUPPLY 15.
Maltese: Kull kunjett fih 20.
English: No NOTEL (No Observed Toxic Effect Level) could be established in the preclinical studies with the exception of a 7-day administration of 0.1 µg/kg in monkeys.
Maltese: ebda livell ta' effett tossiku ma seta' jiġi stabbilit (NOTEL -No Observed Toxic Effect Level) fl-istudji ta' qabel l-użu kliniku bl-eċċezzjoni ta' doża ta' 0.1 µg/kg li ngħatat għal 7 ijiem fix-xadini.
English: MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER (S) RESPONSIBLE FOR BATCH RELEASE
Maltese: MANIFATTUR TAS-SUSTANZA BIJOLOĠIKA ATTIVA U
English: It belongs to a class of medicines known as immunostimulants, which help your body's immune system fight cancer cells.
Maltese: Jappartjeni għal klassi ta' mediċini magħrufa bħala immunostimulanti, li jgħinu lis-sistema immuni tal-ġisem tiġġieled liċ-ċelluli tal-kanċer.
English: Powder vial Type I glass vial with chlorobutyl rubber stopper and sealed with aluminium flip-off cap.
Maltese: Kunjett tal-ħġieġ ta' tip 1 b'tapp sterilizzat tal-gomma chlorobutyl u ssiġillat b'għatu flip-off ta' laluminju
English: A matched-pair survival analysis of patients treated by Beromun and melphalan ILP as compared to a historical control failed to demonstrate any survival difference (p=0.5).
Maltese: L-effetti sekondarji li ġejjin kienu osservati waqt trattament b'din il-mediċina (ikklassifikati skont il frekwenza).
English: ILP should be undertaken in specialised centres by surgical teams experienced in the management of limb sarcomas and ILP procedure, with an intensive care unit readily available and with the facilities for continuous monitoring for medicinal product leakage into the systemic circulation.
Maltese: ILP għandha tingħata f'ċentri speċjaliżżati minn gruppi kirurġiċi li għandhom esperjenza fil-kura tassarkomi tad-driegħ/riġel u fil-proċedura ILP, fejn ikun hemm taqsima tal-kura intensiva b'faċilitajiet għall-monitoraġġ kontinwu li jiċċekkja jekk ikunx hemm tnixxija tal-prodott mediċinali fiċċirkulazzjoni sistemika.
English: The formulation does not contain a preservative and is for single use only.
Maltese: Il-formulazzjoni ma għandhiex preservattiv u għalhekk tintuża darba biss.
English: These changes in turn lead to a procoagulant state, resulting in microvascular thrombosis.
Maltese: Dan it-tibdil, sussegwentement iwassal għal stat prokoagulanti, li jirriżulta fi trombożi mikrovaskulari.
English: Boehringer Ingelheim RCV GmbH & Co KG Dr. Boehringer-Gasse 5-11
Maltese: TIKKETTA TAL-KUNJETT GĦAL BEROMUN
English: Severe lymphoedema of the limb.
Maltese: Limfo-edema gravi tad-driegħ/riġel.