FrancophonIA/ELRC3.0 huggingface dataset:
English: Published data from a field study using a pour-on deltamethrin product indicated that the effects of deltamethrin can persist for a number of weeks and have the potential to affect dung insect populations in some circumstances.
Maltese: Dejta ppubblikata minn studju fuq il-post bl-użu ta' prodott ta' deltamethrin li jitferra' indikat li l-effetti ta' deltamethrin jistgħu jippersistu għal numru ta' ġimgħat u għandhom il-potenzjal li jaffettwaw il-popolazzjonijiet ta' insetti tad-demel f'xi ċirkustanzi.
English: Evaluation of secondary poisoning showed the risk quotient (RQ) values for terrestrial and aquatic predators were <1 and further assessment was not required.
Maltese: L-evalwazzjoni talavvelenament sekondarju wriet li l-valuri tal-kwozjent ta' riskju (RQ) għall-predaturi terrestri u akkwatiċi kienu ta' <1 u ma kinitx meħtieġa aktar valutazzjoni.
English: VICH GL38: Guideline on Environmental Impact Assessment for Veterinary Medicinal Products Phase II (CVMP/VICH/790/03)http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004393.pdf 3 CVMP Guideline on environmental impact assessment for veterinary medicinal products in support of the VICH guidelines
Maltese: VICH GL38: Linja gwida dwar il-Valutazzjoni tal-Impatt Ambjentali għal Prodotti Mediċinali Veterinarji Fażi
English: The efficacy of Deltanil has been demonstrated according to current rules during the decentralised procedure.
Maltese: L-effikaċja ta' Deltanil ġiet murija skont ir-regoli kurrenti matul il-proċedura deċentralizzata.
English: Having considered all the overall submitted data in writing the CVMP concluded that the ERA for Deltanil Pour-On and Spot-on products shows that the products are not expected to pose a risk for the environment when used as recommended in the product information including the recommended RMMs.
Maltese: Din ipprovdiet l-informazzjoni kollha meħtieġa sabiex tkun tista' tintlaħaq konklużjoni dwar irriskju ambjentali ppreżentat mill-użu tal-prodotti.
English: As the active substance is an ectoparasiticide a Phase II ERA was presented.
Maltese: Billi s-sustanza attiva hija ektoparassiċida, kienet ippreżentata ERA ta' Fażi
English: Assessment of the data submitted
Maltese: Valutazzjoni tad-dejta ppreżentata
English: The RMMs and warnings in the Summary of Product Characteristics (SPC) and package leaflet address the risk to dung insects by advising on the frequency of re-treatments and the duration of deltamethrin excretion.
Maltese: Barra minn hekk, kienu kkunsidrati u proposti RMMs għar-riskju identifikat għall-insetti tad-demel.
English: Efficacy was not assessed in this referral procedure.
Maltese: L-effikaċja ma ġietx ivvalutata f'din il-proċedura ta' referenza.
English: Deltamethrin residues will be introduced into the environment following direct excretion onto pasture.
Maltese: Ir-residwi ta' deltamethrin se jiġu introdotti fl-ambjent wara eskrezzjoni diretta fuq il-mergħa.
English: Halaven eribulin
Maltese: Halaven eribulina
English: The full EPAR for Halaven can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: L-EPAR sħiħ għal Halaven jista' jiġi kkonsultat fis-sit elettroniku tal-Aġenzija: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The most common side effects with Halaven (seen in more than 1 patient in 10) are neutropenia (low levels of neutrophils, a type of white blood cell that fights infection), leucopenia (low white blood cell counts), anaemia (low red blood cell counts), reduced appetite, peripheral neuropathy (damage to the nerves in the extremities causing numbness, tingling and prickling sensations), headache, dyspnoea (difficulty breathing), cough, nausea (feeling sick), constipation, diarrhoea, vomiting, alopecia (hair loss), muscle and joint pain or pain in the back or limbs, fatigue (tiredness), pyrexia (fever) and weight loss.
Maltese: L-effetti sekondarji l-aktar komuni b'Halaven (li dehru f ‘aktar minn pazjent 1 minn kull 10) huma newtropenija (livelli baxxi ta' newtrofili, tip ta' ċellola tad-demm bajda li tiġġieled l-infezzjoni), lewkopenija (għadd baxx ta' ċelloli tad-demm bojod), anemija (għadd baxx taċ-ċelloli tad-demm ħomor), nuqqas ta' aptit, newropatija periferika (ħsara fin-nervituri fl-estremitajiet li tikkawża tirżiħ, tnemnim u sensazzjonijiet ta' tniggiż), uġigħ ta' ras, dispnea (diffikultà fin-nifs), sogħla, nawżja (tħossok ma tiflaħx), stitikezza, dijarea, remettar, alopeċja (telf ta' xagħar), uġigħ fil-muskoli u fil-ġogi jew uġigħ fid-dahar jew fir-riġlejn u d-dirgħajn, għejja kbira (għejja), piressija (deni) u telf tal-piż.
English: Other information about Halaven
Maltese: Informazzjoni oħra dwar Halaven
English: In breast cancer, Halaven was studied in two main studies involving a total of 1,864 patients.
Maltese: Fil-kanċer tas-sider, Halaven ġie studjat f'żewġ studji prinċipali li involvew total ta' 1,864 pazjent.
English: This is a summary of the European public assessment report (EPAR) for Halaven.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Halaven.
English: Halaven is a cancer medicine that contains the active substance eribulin.
Maltese: Halaven huwa mediċina kontra l-kanċer li fiha s-sustanza attiva eribulina.
English: The active substance in Halaven, eribulin, is similar to an anticancer substance called halichondrin B, which is found in the marine sponge Halichondria okadai.
Maltese: Is-sustanza attiva f'Halaven, l-eribulina, hija simili għal sustanza kontra l-kanċer imsejħa halichondrin B, li tinstab fl-isponża tal-baħar Halichondria okadai.
English: The study compared Halaven with capecitabine (another cancer medicine).
Maltese: L-istudju qabbel Halaven ma' capecitabine (mediċina oħra kontra l-kanċer).
English: In the second study, there was no significant difference in the average progression-free survival with Halaven (4.1 months) compared with capecitabine (4.2 months) or in the average overall survival with Halaven (15.9 months) compared with capecitabine (14.5 months).
Maltese: Fit-tieni studju, ma kien hemm l-ebda differenza sinifikanti fis-sopravivenza medja ħielsa millprogressjoni tal-marda b'Halaven (4.1 xhur) meta mqabbla ma' capecitabine (4.2 xhur) jew fissopravivenza ġenerali medja b'Halaven (15.9 xhur) meta mqabbla ma' capecitabine (14.5 xhur).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Halaven on 17 March 2011.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Halaven valida fl-Unjoni Ewropea kollha fis-17 ta' Marzu 2011.
English: The calculated dose is given into a vein over two to five minutes on days 1 and 8 of each cycle.
Maltese: Id-doża kkalkulata tingħata ġol-vina fuq perjodu ta' bejn żewġ u ħames minuti f'jum 1 u 8 ta' kull ċiklu.
English: Women in the Halaven group lived for an average of 13.1 months, compared with 10.6 months in the group that received other treatments.
Maltese: Nisa fil-grupp ta' Halaven għexu medja ta' 13.1 xhur, meta mqabbla ma' 10.6 xhur fil-grupp li rċevew kuri oħra.
English: The second study involved 1,102 patients with advanced or metastatic breast cancer, with one or two previous treatments for advanced/metastatic cancer including an anthracycline and a taxane.
Maltese: It-tieni studju involva 1,102 pazjenti b'kanċer tas-sider avvanzat jew metastatiku, b'kura waħda preċedenti jew tnejn kontra l-kanċer avvanzat/metastatiku inklużi l-antraċiklina u t-tassani.
English: What is Halaven?
Maltese: X'inhu Halaven?
English: Halaven is given as intravenous (into a vein) injections over 21-day cycles.
Maltese: Halaven jingħata bħala injezzjonijiet intravenużi (ġol-vina) f'ċikli ta' 21-jum.
English: What is the risk associated with Halaven?
Maltese: X'inhu r-riskju assoċjat ma' Halaven?
English: The third study showed that Halaven was effective at prolonging life in patients with liposarcoma: patients treated with Halaven lived for an average of 15.6 months, compared with 8.4 months for patients treated with dacarbazine.
Maltese: It-tielet studju wera li Halaven kien effettiv fit-titwil tal-ħajja f'pazjenti b'liposarkoma: il-pazjenti kkurati b'Halaven għexu medja ta' 15.6 xhur, meta mqabbla ma' 8.4 xhur għal pazjenti li kienu kkurati b'dakarbazina.
English: Why has Halaven been approved?
Maltese: Għaliex ġie approvat Halaven?
English: Halaven was compared with dacarbazine (another cancer medicine), and the main measure of effectiveness was overall survival.
Maltese: Halaven tqabbel mad-dakarbazina (mediċina oħra tal-kanċer), u l-kejl ewlieni tal-effikaċja kien is-sopravivenza ġenerali.
English: How does Halaven work?
Maltese: Għal xiex jintuża Halaven?
English: When Halaven was used as breast cancer second-line therapy (after at least one previous cancer treatment for advanced/metastatic disease), Halaven was a valuable treatment option similar to capecitabine and with an acceptable safety profile.
Maltese: Meta Halaven intuża bħala terapija tat-tieni linja għall-kanċer tas-sider (wara mill-inqas kura waħda preċedenti kontra l-kanċer għall-marda avvanzata/metastatika), Halaven kien għażla ta' kura siewja simili għal capecitabine u bi profil tas-sigurtà aċċettabbli.
English: The CHMP decided that Halaven's benefits are greater than its risks and recommended that it be given marketing authorisation.
Maltese: Is-CHMP iddeċieda li l-benefiċċji ta' Halaven huma akbar mir-riskji tiegħu u rrakkomanda li jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: How has Halaven been studied?
Maltese: Kif ġie studjat Halaven?
English: 12 sachets l t o r
Maltese: 12-il borża żgħira t x
English: Package size
Maltese: Il-Pakkett
English: Sachet (alu)
Maltese: Isem ivvintat
English: Invented name Strength Pharmaceutical Form Route of administration Packaging
Maltese: Kemm jesa ilpakkett
English: EMEA Procedure number
Maltese: In-numru tal-Proċedura ta' lEMEA
English: Preparation Date: ______________ Preparation Time: ______________ Prepared By: __________________
Maltese: Data ta' Preparazzjoni: ______________
English: Risk Ratio (95% C.I.)
Maltese: Riskju Proporzjonali (95% C.I.)
English: Polígon Industrial Els Vinyets - Els Fogars, Sector 2, Carretera Comarcal C244, km 22 08777 Sant Quintí de Mediona (Barcelona) Spain
Maltese: Polígon Industrial Els Vinyets - Els Fogars, Sector 2, Carretera Comarcal C244, km 22 08777 Sant Quintí de Mediona (Barcelona) Spanja
English: Palmar-plantar erythrodysaesthesia syndrome
Maltese: Sindrome palmar-plantar eritrodisaetesija
English: Grades ≥ 3
Maltese: Gradi ≥ 3
English: Standard dose of 60 - 75mg/m2
Maltese: Doża standard ta' 60 - 75mg/m2
English: Carton contents:
Maltese: Kontenut tal-kartuna:
English: Less than 25,000
Maltese: Inqas minn 25,000
English: Liposomal doxorubicin hydrochloride
Maltese: Liposomali doxorubicin hydrochloride
English: Vial 2 - liposomes
Maltese: Kunjett 2 - liposomi
English: Oliguria
Maltese: Oligurija
English: Myocet liposomal liposomes
Maltese: Myocet liposomal liposomi
English: Bilirubin < ULN and normal AST
Maltese: Bilirubin < ULN u AST normali
English: Bilirubin > ULN but < 50 μmol/l
Maltese: Bilirubin > ULN imma < 50 μmol/l
English: This medicine is normally given by a doctor or nurse.
Maltese: Din il-mediċina normalment tingħata minn tabib jew infermiera.
English: Vial 2 - liposomes phosphatidylcholine, cholesterol, citric acid, sodium hydroxide, water for injections
Maltese: Kunjett 2 - liposomi phosphatidylcholine, cholesterol, citric acid, sodium hydroxide, ilma għall-injezzjoni
English: During clinical trials, the most frequently reported adverse reactions were nausea/vomiting (73%), leucopoenia (70%), alopecia (66%), neutropenia (46%), asthenia/fatigue (46%), stomatitis/mucositis (42%), thrombocytopenia (31%) and anaemia (30%).
Maltese: Matul il-provi kliniċi, l-iktar reazzjonijiet avversi li kienu rrappurtati b'mod frekwenti kienu nawseja/rimettar (73%), lewkopenija (70%), alopeċja (66%), newtropenija (46%), astenja/għeja kbira (46%), stomatite/mukożite (42%), tromboċitopenija (31%) u anemija (30%).
English: Vial 3 - buffer
Maltese: Kunjett 3 - baffer
English: Step 5.
Maltese: Stadju 5.
English: It is used with another medicine called “cyclophosphamide”.
Maltese: Jintuża ma' mediċina oħra msejħa “cyclophosphamide”.
English: • the medicine “cyclophosphamide” is given on the same day.
Maltese: • il-mediċina “cyclophosphamide” tingħata fl-istess jum.
English: Myocet liposomal/CP A
Maltese: Myocet liposomal /CPA
English: Myocet liposomal buffer
Maltese: Myocet liposomal baffer
English: • phenobarbital or phenytoin - for epilepsy
Maltese: • phenobarbital jew phenytoin - għal kura ta' epilessija
English: Vial 3 - buffer sodium carbonate, water for injections
Maltese: Kunjett 3 - baffer sodium carbonate, ilma għall-injezzjoni
English: Consider a 25% dose reduction
Maltese: Ikkonsidra tnaqqis ta'25% tad-doża
English: However, reduction of the QRS complex is considered more indicative of cardiac toxicity.
Maltese: Madankollu, tnaqqis tal-kumpless QRS huwa kkunsidrat iktar indikattiv ta' tossiċità kardijaka.
English: Nadir ANC (cells/µl)
Maltese: Aktar Baxx ta' ANC (celluli /µl)
English: Gastroinstestinal disorders
Maltese: Disturbi gastro-intestinali
English: This corresponds to 50 mg doxorubicin hydrochloride.
Maltese: Dan jikkorrispondi għal 50 mg ta' doxorubicin hydrochloride.
English: The drip will be stopped straight away.
Maltese: Id-dripp ser titwaqqaf immedjatment.
English: Haematological Toxicity
Maltese: Tossiċità Ematoloġika
English: Myocet liposomal (60 mg/m2) + CPA (600 mg/m2) was compared with conventional doxorubicin + CPA (at the same doses) and Myocet liposomal (75 mg/m2) + CPA (600 mg/m2) was compared to epirubicin + CPA (at the same doses).
Maltese: Myocet liposomal (60 mg/m2) + CPA (600 mg/m2) kienu pparagunati ma' doxorubicin konvenzjonali + CPA (fl-istess dożi ) u Myocet liposomal (75 mg/m2) + CPA (600 mg/m2) kienu pparagunati ma' epirubicin + CPA (fl-istess dożi).
English: Myocet liposomal is supplied as a three-vial system: (1) doxorubicin HCl, (2) liposomes, and (3) buffer.
Maltese: (1) doxorubicin HCl, (2) liposomi, u (3) baffer.
English: Increased alkaline phosphatase
Maltese: Żieda f'alkaline phosphatase
English: Analyses of cardiotoxicity in clinical trials have shown a statistically significant reduction in cardiac events in patients treated with Myocet liposomal compared to patients treated with conventional doxorubicin at the same dose in mg. A meta-analysis showed a statistically significant lower rate of both clinical heart failure (RR = 0.20, p=0.02) and clinical and subclinical heart failure combined (RR = 0.38, p<0.0001) in patients treated with Myocet liposomal versus conventional doxorubicin.
Maltese: Analiżi ta' kardjotossiċità fi provi kliniċi wrew tnaqqis statistikament sinjifikanti f'każi kardijaċi f'pazjenti kkurati b'Myocet liposomal meta mqabbla ma' pazjenti kkurati b'doxorubicin konvenzjonali fl-istess doża f'mg. Meta-analiżi wriet rata iktar baxxa b'mod statistikament sinifikanti kemm ta' insuffiċjenza tal-qalb (RR = 0.20, p=0.02) u insuffiċjenza tal-qalb klinika u subklinika kkombinata (RR = 0.38, p<0.0001) f'pazjenti kkurati b'Myocet liposomal kontra doxorubicin konvenzjonali.
English: Available pharmacokinetic data preclude conclusions regarding the relationship between plasma levels of total/free doxorubicin and its influence on the efficacy/safety of Myocet liposomal.
Maltese: Informazzjoni farmakokinetika disponibbli tipprekludi li jsiru konklużjonijiet rigward ir-relazzjoni bejn livelli totali/doxorubicin liberu fil-plażma u l-influwenza tiegħu fuq l-effikaċja / sigurtà ta' Myocet liposomal.
English: Gastric ulcer
Maltese: Ulċera gastrika
English: Doxorubicin and other anthracyclines can cause cardiotoxicity.
Maltese: Doxorubicin u anthracyclines oħrajn jistgħu jikkaġunaw tossiċità kardijaka.
English: Injection site infection
Maltese: Infezzjonijiet u infestazzjonijiet
English: A final concentration of between 0.4 mg/ml to 1.2 mg/ml doxorubicin HCl, is required.
Maltese: Konċentrazzjoni finali ta' bejn 0.4 mg/ml sa 1.2 mg/ml ta' doxorubicin HCl, hi meħtieġa.
English: Date of first authorisation: 13 July 2000 Date of latest renewal: 02 July 2010
Maltese: Data tal-aħħar tiġdid: 02 Lulju 2010
English: 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 webportal
Maltese: 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: Liver function tests
Maltese: DATA TA' REVIŻJONI TAT-TEST
English: Abbreviations: PFS, progression-free survival; Dox, doxorubicin; Epi, epirubicin; Relative Risk, comparator taken as reference; Risk Ratio, Myocet liposomal taken as reference a
Maltese: Riskju Relattiv, komparatur meħud bħala referenza; Riskju Proporzjonali, Myocet liposomal meħud bħala referenza a Punt ta' referenza terminali sekondarju
English: Step 1.
Maltese: 1 Stadju.
English: • WAIT FOR A MINIMUM OF 10 MINUTES BEFORE USING, KEEPING THE MEDICINE AT ROOM TEMPERATURE.
Maltese: • STENNA għal mill-inqas 10 MINUTI qabel ma tużah, u żomm il-mediċina fit-temperatura tal kamra.
English: The reduced risk of cardiotoxicity has also been shown in a retrospective analysis in patients who had received prior adjuvant doxorubicin (log-rank P=0.001, Hazard Ratio=5.42).
Maltese: Ir-riskju mnaqqas ta' kardjotossiċità ntwera f'analiżi retrospettiva f'pazjenti li kienu rċivew adjuvant doxorubicin fil-passat (log-rank P=0.001, Proporzjon ta' Periklu=5.42).
English: Pharmaco-therapeutic group: Antineoplastic agents, anthracyclines and related substances, ATC code: L01DB01
Maltese: Sustanzi antineoplastiċi, anthracyclines u sustanzi relatati, Kodiċi ATC:
English: Remove venting device.
Maltese: Dejta mhux disponibbli.
English: - The other ingredients are lactose (in the doxorubicin HCl vial), phosphatidylcholine, cholesterol, citric acid, sodium hydroxide and water for injections (in the liposomes vial), and sodium carbonate and water for injections (in the buffer vial).
Maltese: - Is-sustanzi l-oħra huma lactose (fil-kunjett ta' doxorubicin HCl), phosphatidylcholine, kolesterol, citric acid, sodium hydroxide u ilma għall-injezzjonijiet (fil-kunjett b'liposomi), u sodium carbonate u ilma għall-injezzjonijiet (fil-kunjett tal-baffer).
English: Chemical and physical in-use stability after reconstitution has been demonstrated for up to 8 hours at 25°C, and for up to 5 days at 2°C - 8
Maltese: 25°C, u sa 5 t'ijiem f'temperaturi ta' bejn 2°C - 8 οC.
English: A meta-analysis showed a statistically significant lower rate of nausea/vomiting grade ≥ 3 (RR = 0.65, p=0.04) and diarrhoea grade ≥ 3(RR = 0.33, p=0.03) in patients treated with Myocet liposomal versus conventional doxorubicin.
Maltese: Meta-analiżi wriet rata iktar baxxa b'mod statistikament sinifikanti ta' nawseja/rimettar ta' grad ≥ 3 (RR = 0.65, p=0.04) u dijarea ta' grad ≥ 3(RR = 0.33, p=0.03) f'pazjenti kkurati b'Myocet liposomal kontra doxorubicin konvenzjonali.
English: Doxorubicin may exert its antitumour and toxic effects by a number of mechanisms including inhibition of topoisomerase II, intercalation with DNA and RNA polymerases, free radical formation and membrane binding.
Maltese: Doxorubicin għandu mnejn jeżerċita leffetti ta' kontra t-tumur u l-effetti tossiċi b'numru ta' mekkaniżmi li jinkludu l-impediment ta' topoisomerase II, interkalazzjoni b' DNA u RNA polymerases, formazzjoni ta' radikali ħielsa u tirbit mar-riti.
English: Data from randomised controlled clinical trials show that the efficacy and cardiac safety of Myocet liposomal in this population was comparable to that observed in patients less than 65 years old.
Maltese: Informazzjoni miġbura minn randomised controlled clinical trtials turi li l-effikaċja u s-sigurtà kardijaka ta' Myocet liposomal f'din il-popolazzjoni kienu paragunabbli ma' dawk osservati f'pazjenti li għandhom inqas minn 65 sena.
English: • Heat the reconstituted doxorubicin HCl vial in the Techne DB-3 Dri Block heater with the thermometer in the block reading (75°C-76°C) for 10 minutes (not to exceed 15 minutes).
Maltese: • Saħħan il-kunjett ta' doxorubicin HCl rikostitwit f' ħijter Techne DB-3 Dri Block bit-termometru fil-blokk jaqra (75°C-76°C) għal 10 minuti (m'għandhiex taqbez 15-il minuta).
English: Cytotoxic.
Maltese: Citotossiku.
English: After reconstitution the finished product must be further diluted in 0.9% (w/v) sodium chloride solution for injection, or 5% (w/v) glucose solution for injection to a final volume of 40 ml to 120 ml per 50 mg reconstituted Myocet liposomal so that a final concentration of 0.4 mg/ml to 1.2 mg/ml doxorubicin is obtained.
Maltese: Wara li jiġi rikostitwit, il-prodott finali għandu jiġi dilwit aktar b'soluzzjoni ta' 0.9% (w/v) sodium chloride għall-injezzjonijiet, jew soluzzjoni ta' 5% (w/v) glucose għall-injezzjoni sa volum fl-aħħar ta' soluzzjoni ta' 40 ml sa 120 ml kull 50 mg ta' Myocet liposomal rikostitwit sabiex il-konċentrazzjoni finali ta' doxorubicin tkun ta' bejn 0.4 mg/ml sa 1.2 mg/ml.
English: Adverse reactions are listed below as MedDRA preferred term by system organ class and frequency (frequencies are defined as: very common ≥1/10, common ≥1/100 to <1/10, uncommon ≥ 1/1,000 to <1/100, not known (cannot be estimated from the available data).
Maltese: Ir-reazzjonijiet avversi huma elenkati hawn taħt bħala terminu ppreferut skont il-klassi tal-organi tas-sistema u l-frekwenza (il-frekwenzi huma definiti bħala komuni ħafna ≥1/10; komuni ≥1/100 sa <1/10; mhux komuni ≥1/1,000 sa <1/100, mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: 4 Less than 500
Maltese: Inqas minn 500
English: 75% dose reduction
Maltese: Tnaqqis b'75% tad-doża
English: Myocet liposomal doxorubicin HCl IV use
Maltese: Myocet liposomal doxorubicin HCl
English: • streptozotocin - for cancer of the pancreas
Maltese: • streptozotocin - għal kura ta' kanċer tal-frixa
English: The number of times you have the drip depends on:
Maltese: In-numru ta' drabi li ser tingħata d-dripp jiddependi fuq:
English: phenobarbital, phenytoin and warfarin.
Maltese: Ġew irrapportati wkoll interazzjonijiet ma' doxorubicin għal streptozocin, phenobarbital, phenytoin u warfarin.
English: Liposome-encapsulated doxorubicin corresponding to 50 mg doxorubicin hydrochloride
Maltese: Doxorubicin inkapsulat f'liposomi, li jikkorrispondi għal 50 mg ta' doxorubicin hydrochloride
English: • Withdraw 1.9 ml of liposomes.
Maltese: • Iġbed 1.9 ml ta' liposomi.
English: IV
Maltese: L
English: The active substance in Myocet liposomal is doxorubicin HCl.
Maltese: Is-sustanza attiva f' Myocet liposomal hija doxorubicin HCl.
English: For precautions regarding the use of Myocet liposomal with other medicinal products, see section 4.5.
Maltese: Għal prekawzjonijiet rigward l-użu ta' Myocet liposomal ma' prodotti mediċinali oħrajn, ara sezzjoni 4.5.
English: • Turn on the Techne DB-3 Dri Block heater and set the controller to 75°C-76°C.
Maltese: • Ixgħel il-ħijter Techne DB-3 Dri Block u qiegħed l-kontrollur fuq 75°C-76°C.
English: - The active substance is liposome-encapsulated doxorubicin.
Maltese: - Is-sustanza attiva hu doxorubicin inkapsulat f'liposomi.
English: In a phase III study comparing single-agent Myocet liposomal (75 mg/m2) versus single-agent doxorubicin (75 mg/m2), 12% versus 27% of patients, respectively developed a significant decrease in LVEF.
Maltese: III meta ġie mqabbel Myocet liposomal waħdu (75 mg/m2) ma' doxorubicin waħdu (75 mg/m2), 12% kontra 27% tal-pazjenti rispettivament żviluppaw tnaqqis sinifikanti fl-LVEF.
English: Stomatitis/mucositis
Maltese: STIKER/BIĊĊA
English: Liposome-encapsulated doxorubicin-citrate complex corresponding to 50 mg doxorubicin hydrochloride (HCl).
Maltese: U KWANTITATTIVA Kumpless ta' doxorubicin-citrate enkapsulat f'liposoma li jikkorispondi għal 50 mg doxorubicin hydrochloride (HCl).