FrancophonIA/ELRC3.0 huggingface dataset:
English: • Tasermity should not be taken at the same time as ciprofloxacin (an antibiotic).
Maltese: • Tasermity m'għandux jittieħed fl-istess żmien ma' ciprofloxacin (antibijotiku).
English: Pharmacotherapeutic group: Treatment of hyperphosphatemia.
Maltese: Kura tal-iperfosfatemja.
English: Ελλάδα sanofi-aventis AEBE
Maltese: UAB „SANOFI-AVENTIS LIETUVA“
English: This risk can be reduced by careful adherence to sterile techniques during bag changes.
Maltese: Dan ir-riskju jista' jitnaqqas bl-osservanza attenta għat-tekniċi sterili matul il-bidliet tal-borża.
English: Package leaflet: Information for the user Tasermity 800 mg film-coated tablets sevelamer hydrochloride
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kull pillola fiha 800 mg sevelamer hydrochloride.
English: Other medicines and Tasermity
Maltese: INFORMAZZJONI BIL-BRAILLE Tasermity
English: Initially your doctor will check the levels of phosphate in your blood every 2-3 weeks and may adjust the dose of Tasermity when necessary (between 1 and 5 tablets of 800 mg per meal) to reach an adequate phosphate level.
Maltese: Fil-bidu t-tabib tiegħek ser jiċċekkja l-livelli ta' fosfat fid-demm tiegħek kull 2-3 ġimgħat u hu/hi għandu/għandha mnejn jaġġusta/taġġusta d-doża ta' Tasermity, jekk dan ikun meħtieġ, (ta' bejn 1 u 5 pilloli ta' 800 mg ma' kull ikla), biex tilħaq livell adattat ta' fosfat.
English: It contains multiple amines separated by one carbon from the polymer backbone.
Maltese: Fih amini multipli li huma separati permezz ta' carbon wieħed mill istruttura ċentrali tal-polimer.
English: The safety of sevelamer hydrochloride has not been established in pregnant women.
Maltese: Tqala Is-sigurtà ta' sevelamer hydrochloride ma ġietx determinata f'nisa tqal.
English: 5.3 Preclinical safety data
Maltese: sensittività eċċessiva
English: 180 film-coated tablets
Maltese: Pillola 1, 3 darbiet kuljum
English: Long term chronic treatment
Maltese: TAL-PRODOTT MEDIĊINALI
English: By binding phosphate in the gastrointestinal tract, sevelamer lowers the phosphate concentration in the serum.
Maltese: Sevelamer jbaxxi l konċentrazzjoni ta' fosfat fis-serum għax jorbot fosfat fl-apparat gastrointestinali.
English: 5 PHARMACOLOGICAL PROPERTIES 5.1 Pharmacodynamic properties
Maltese: .1 Proprjetajiet farmakodinamiċi Kategorija farmakoterapewtika:
English: Sevelamer hydrochloride should only be given to pregnant women if clearly needed and after a careful risk/benefit analysis has been conducted for both the mother and the foetus (see section 5.3).
Maltese: Sevelamer hydrochloride għandu jingħata biss lin-nisa li qed ireddgħu jekk hu verament meħtieġ u wara li ssir analiżi bir-reqqa tar-riskju/benefiċċju fuq l-omm u l-fetu u t-tarbija (ara sezzjoni 5.3 ).
English: Increased levels of serum phosphorus can lead to hard deposits in your body called calcification.
Maltese: Livelli ogħla ta' fosforu fis-serum jista' jwassal għal depożiti iebsin fil-ġisem tiegħek, kundizzjoni li tissejjaħ kalċifikazzjoni.
English: Very rare (may affect up to 1 in 10000 people): hypersensitivity.
Maltese: Rari ħafna (jistgħu jaffettwaw sa persuna 1 minn kull 10000):
English: Tasermity is indicated for the control of hyperphosphataemia in adult patients receiving haemodialysis or peritoneal dialysis.
Maltese: Tasermity hu indikat għall-kontroll ta' l-iperfosfatemija f'pazjenti adulti li qed jirċievu dijalisi tad demm jew dijalisi peritoneali.
English: Tasermity is used to control the levels of phosphate in the blood of adult kidney failure patients on haemodialysis or peritoneal dialysis treatment.
Maltese: Tasermity jintuża biex jiġi kkontrollat il-livell tal-fosfat fid-demm f'pazjenti adulti b'insuffiċjenza talkliewi u li qegħdin fuq kura ta' emodijalisi jew dijalisi peritoneali.
English: • In certain people taking levothyroxine (a thyroid hormone) and Tasermity, increased levels of thyroid stimulating hormone (TSH, a substance in your blood which helps control your body's chemical functions) may very rarely be observed.
Maltese: Tasermity kien hemm żieda fil-livelli tal-ormon li jistimula t-tirojde (TSH, sustanza fid-demm tiegħek li jgħin biex jiġu kkontrollati il-funzjonijiet kimiċi tal-ġisem tiegħek).
English: Tablet core:
Maltese: Madankollu,
English: 49 x 1 tablets (unit dose)
Maltese: 196 pillola (2 pakketti ta' 98)
English: Tradename Strength Pharmaceutical Form
Maltese: Prodott mediċinali li m'għadux awtorizzat
English: Packaging
Maltese: Ippakkjar Daqs tal-pakkett
English: EU Number
Maltese: Numru ta' l-UE Isem kummerċjali Qawwa Għamla
English: Ref. EMA/318692/2007
Maltese: EMA/382238/2007
English: 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 75 23 71 29 E-mail: mail@emea.europa.eu http://www.emea.europa.eu EMEA 2007 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged
Maltese: (44-20) 74 18 84 00 Fax (44-20) 75 23 71 29 E-mail: mail@emea.eu.int http://www.emea.eu.int EMEA 2007 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged
English: Active substance: adenovirus-mediated Herpes simplex virus-thymidine kinase gene
Maltese: Sustanza attiva: adenovirus-mediated Herpes simplex virus-thymidine kinase gene
English: London, 19 July 2007 Doc.
Maltese: Londra, id-19 ta' Lulju 2007 Dok. Ref.
English: The evaluation had finished and the CHMP had given a negative opinion.
Maltese: L-evalwazzjoni kienet intemmet u l-CHMP kien ta opinjoni negattiva.
English: What is Cerepro?
Maltese: X'inhu Cerepo?
English: Cerepro was intended for use during an operation.
Maltese: Cerepro kien maħsub għal użu waqt operazzjoni.
English: The study compared the effects of adding Cerepro and ganciclovir sodium to standard treatment with the effects of standard treatment alone.
Maltese: L-istudju qabbel l-effetti taż-żieda ta' Cerepro u ganciclovir sodium mat-trattament standard ma' l-effetti tat-trattament standard waħdu.
English: Cerepro is a medicine containing a gene (a Herpes simplex virus thymidine kinase gene) carried by an adenovirus.
Maltese: Cerepro hu mediċina li jkun fiha ġene (ġene tat-tip Herpes simplex virus thymidine kinase) li jinġarr minn adenovirus.
English: Cerepro was designated an orphan medicinal product on 6 February 2002.
Maltese: Cerepro ġie kklassifikat bħala prodott mediċinali orfni fis-6 ta' Frar 2002.
English: Cerepro contains the gene for the enzyme ‘thymidine kinase' from the herpes virus.
Maltese: Cerepro fih ġene għall-enzim ‘thymidine kinase' mill-virus tal-ħerpes.
English: The cells then start to produce the thymidine kinase enzyme.
Maltese: Iċċelloli mbagħad jibdew jipproduċu l-enzim thymidine kinase.
English: It is made up into a solution that is injected directly into the brain during surgery.
Maltese: Huwa magħmul minn soluzzjoni li tiġi injettata direttament fil-moħħ waqt kirurġija.
English: What was Cerepro expected to be used for?
Maltese: Kif kien mistenni li jaħdem Cerepro?
English: Cerepro has also been studied in 36 patients with high-grade glioma.
Maltese: Cerepro ġie studjat f'36 pazjent bi glijoma ta' grad għoli.
English: Based on the review of the data and the company's response to the CHMP list of questions, at the time of the withdrawal, the CHMP had given a negative opinion and did not recommend a marketing authorisation for Cerepro for the treatment of patients with operable high-grade glioma.
Maltese: Abbażi ta' l-analiżi tad-dejta u r-rispons tal-kumpanija għal-lista ta' mistoqsijiet, fi żmien l-irtar, ilCHMP kien ta opinjoni negattiva u ma rrakomandax li tingħata l-awtorizzazzjoni għat-tqegħid fis-suq għal Cerepro għat-trattament ta' pazjenti bi glijoma ta' grad għoli li setgħu jiġu operati.
English: The virus in Cerepro is an ‘adenovirus' that has been engineered so that it cannot make copies of itself and therefore does not cause infections in humans.
Maltese: Il-virus f'Cerepro hu ‘adenovirus' li jkun ġie manipulat biex ma jkunx jista' jagħmel kopji tiegħu nnifsu u għalhekk ma jikkawżax infezzjonijiet fil-bniedem.
English: After removing as much of the brain tumour as possible, the surgeon would have made up to 70 small injections of Cerepro into the area from where the tumour was removed.
Maltese: Wara t-tneħħija ta' kemm jista' jkun mit-tumur talmoħħ, il-kirurgu kien jinjetta sa 70 injezzjoni żgħira ta' Cerepro fiż-żona minn fejn ikun tneħħa ttumur.
English: This enzyme helps to convert ganciclovir into a form which can kill cells that are dividing, including any cancerous cells that were not removed during the operation.
Maltese: L-enzim jgħin biex jikkonverti ganciclovir f'forma li tista' toqtol ċelloli li jkunu qed jinqasmu, inkluż ċelloli tal-kanċer li ma jkunux tneħħew waqt l-operazzjoni.
English: On 13 July 2007, Ark Therapeutics officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Cerepro, for the treatment of patients with operable high-grade glioma.
Maltese: Fit-13 ta' Lulju 2007, Ark Therapeutics uffiċjalment għarrfu lill-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) li jixtiequ jirtiraw l-applikazzjoni tagħhom għall-awtorizzazzjoni tat-tqegħid fis-suq għal Cerepro, użata għat-trattament ta' pazjenti li l-glijoma ta' grad għoli tagħhom tista' tiġi operata.
English: The effects of Cerepro were first tested in experimental models before being studied in humans.
Maltese: L-effetti ta' Cerepo għall-ewwel ġew ittestjati fuq mudelli esperimentali qabel ma ġew studjati filbniedem.
English: What are the consequences of the withdrawal for patients in clinical trials with Cerepro?
Maltese: Għal x'hiex kien mistenni li jintuża Cerepro?
English: Cerepro would only have worked in combination with ganciclovir.
Maltese: Cerepro kien jaħdem biss flimkien ma' ganciclovir.
English: Glioma is a type of brain tumour that begins in ‘glial' cells (the cells that surround and support nerve cells).
Maltese: Il-glijoma hi tip ta' tumur fil-moħħ li tibda fiċ-ċelloli 'glijali' (iċ-ċelloli li jiċċirkundaw u li jappoġġjaw iċ-ċelloli tan-nervituri).
English: When Cerepro is injected into the brain, the modified virus is taken up by the cells near the injection sites.
Maltese: Meta Cerepro jiġi injettat fil-moħħ, il-virus modifikat jidħol fiċ-ċelloli qrib is-siti ta' l-injezzjoni.
English: The gene is carried within a ‘vector', a type of virus that has been altered genetically so that it can carry a gene (DNA) into the cells of the body.
Maltese: Il-ġene jinġarr f'‘vector', tip ta' virus li jkun ġie mibdul ġenetikament biex ikun jista' jġorr ġene (DNA) fiċ-ċelloli tal-ġisem.
English: Further information on Nivestim can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/nivestim.
Maltese: ema.europa.eu/medicines/human/EPAR/nivestim.
English: Nivestim is a ‘biosimilar' medicine.
Maltese: Nivestim huwa mediċina “bijosimili”.
English: Nivestim contains the active substance filgrastim.
Maltese: Nivestim fih is-sustanza attiva filgrastim.
English: The active substance in Nivestim, filgrastim, is very similar to a human protein called granulocyte colony stimulating factor (G-CSF).
Maltese: Is-sustanza attiva f'Nivestim, filgrastim, hija simili ħafna għal proteina umana msejħa fattur stimolanti tal-kolonja tal-granuloċiti (G-CSF).
English: The reference medicine for Nivestim is Neupogen.
Maltese: Il-mediċina ta' referenza għal Nivestim hija Neupogen.
English: Nivestim received a marketing authorisation valid throughout the EU on 8 June 2010.
Maltese: Nivestim ingħata awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fit-8 ta' Ġunju 2010.
English: Why is Nivestim approved?
Maltese: Għaliex Nivestim ġie approvat?
English: What are the risks associated with Nivestim?
Maltese: X'inhuma r-riskji assoċjati ma' Nivestim?
English: Laboratory studies comparing Nivestim with Neupogen have shown that the active substance in Nivestim is highly similar to that in Neupogen in terms of structure, purity and biological activity.
Maltese: Studji fil-laboratorji li qabblu Nivestim ma' Neupogen urew li s-sustanza attiva f'Nivestim hija simili ħafna għal dik f'Neupogen f'termini ta' struttura, purità u attività bijoloġika.
English: In addition, a study in 279 female adult patients with breast cancer who were being treated with cancer medicines showed that Nivestim is comparable to the reference medicine, Neupogen.
Maltese: Barra minn hekk, studju fuq 297 pazjenta adulta bil-kanċer tas-sider li kienu qed jiġu kkurati bilmediċini kontra l-kanċer wera li Nivestim huwa komparabbli mal-mediċina ta' referenza, Neupogen.
English: The most common side effects with Nivestim (which may affect more than 1 in 10 people) are fever, musculoskeletal pain (pain in the muscles and bones), anaemia (low red blood cell counts), vomiting and nausea (feeling sick).
Maltese: L-effetti sekondarji l-aktar komuni b'Nivestim (li jistgħu jaffettwaw aktar minn persuna waħda minn kull għaxra) huma deni, uġigħ muskoloskeletali (uġigħ fil-muskoli u fl-għadam), anemija (għadd baxx taċ-ċelloli ħomor tad-demm), rimettar u dardir (tħossok ma tiflaħx).
English: • to reduce the duration of neutropenia (low levels of neutrophils, a type of white blood cell) and to prevent febrile neutropenia (neutropenia with fever) in cancer patients (excluding patients with chronic myeloid leukaemia or with myelodysplastic syndromes).
Maltese: • biex inaqqas kemm iddum in-newtropenija (livelli baxxi ta' newtrofili, tip ta' ċellola bajda taddemm) u biex jipprevjeni newtropenija febrili (newtropenija bid-deni) f'pazjenti bil-kanċer (minbarra pazjenti b'lewkimja mijelojde kronika jew b'sindromi mijelodisplastiċi).
English: The medicine is available in pre-filled syringes and is given by injection under the skin or infusion (drip) into a vein.
Maltese: Il-mediċina tiġi f'siringi mimlijin lesti u tingħata permezz ta' injezzjoni taħt ilġilda jew infużjoni (dripp) ġo vina.
English: This means that Nivestim is highly similar to another biological medicine (the ‘reference medicine') that is already authorised in the EU.
Maltese: Dan ifisser li Nivestim huwa simili ħafna għal mediċina bijoloġika oħra (il-”mediċina ta' referenza”) li diġà hija awtorizzata fl-UE.
English: • to treat persistent neutropenia in patients with advanced human immunodeficiency virus (HIV)
Maltese: • biex jikkura newtropenija persistenti f'pazjenti bil-virus uman tal-immunodefiċjenza fi stat avvanzat (HIV), biex inaqqas ir-riskju ta' infezzjonijiet batteriċi meta kuri oħra ma jkunux adegwati.
English: Nivestim is a medicine that stimulates the production of white blood cells and is used:
Maltese: Nivestim huwa mediċina li tistimula l-produzzjoni ta' ċelloli bojod tad-demm u jintuża:
English: Filgrastim works in the same way as naturally produced G-CSF by encouraging the bone marrow to produce more white blood cells.
Maltese: Filgrastim taħdem bl-istess mod bħal G-CSF li tiġi prodotta b'mod naturali billi tistimola lill-mudullun biex jipproduċi aktar ċelloli bojod tad-demm.
English: For the full list of side effects and restrictions with Nivestim, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet b'Nivestim, ara l-fuljett ta' tagħrif.
English: The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Nivestim has a highly similar structure, purity and biological activity to Neupogen and is distributed in the body in the same way.
Maltese: L-Aġenzija Ewropea għall-Mediċini ddeċidiet li, b'mod konformi mar-rekwiżiti tal-UE għal mediċini bijosimili, Nivestim għandu struttura, purità u attività bijoloġika simili ħafna għal Neupogen u jiġi distribwit bl-istess mod fil-ġisem.
English: Other information about Nivestim
Maltese: Informazzjoni oħra dwar Nivestim
English: Because Nivestim is a biosimilar medicine the studies on effectiveness and safety of filgrastim carried out with Neupogen do not all need to be repeated for Nivestim.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Nivestim hija ssorveljata kontinwament.
English: • to increase levels of neutrophils and reduce the risk of infections in patients with neutropenia who have a history of severe, repeated infections;
Maltese: • biex iżid il-livelli ta' newtrofili u jnaqqas ir-riskju ta' infezzjonijiet f'pazjenti b'newtropenija li jkollhom storja ta' infezzjonijiet severi u repetuti;
English: The safety of Nivestim has been evaluated, and on the basis of all the studies carried out the side effects of the medicine are considered to be comparable to those of the reference medicine Neupogen.
Maltese: Is-sigurtà ta' Nivestim ġiet evalwata, u abbażi tal-istudji kollha li saru, l-effetti sekondarji tal-mediċina jitqiesu li huma komparabbli ma' dawk tal-mediċina ta' referenza Neupogen.
English: The patients who received Nivestim had severe neutropenia for a similar length of time as the patients who received Neupogen.
Maltese: Il-pazjenti li ngħataw Nivestim kellhom newtropenija gravi għal tul ta' ħin simili għal dawk li ngħataw Neupogen.
English: How does Nivestim work?
Maltese: Kif jaħdem Nivestim?
English: Studies have also shown that giving Nivestim produces similar levels of the active substance in the body to giving Neupogen.
Maltese: L-istudji wrew ukoll li lgħoti ta' Nivestim jipproduċi livelli simili tas-sustanza attiva fil-ġisem bħall-għoti ta' Neupogen.
English: How is Nivestim used?
Maltese: Nivestim?
English: The product was subsequently approved in AT, BE, DE, DK, EE, ES, FI, HR, IE, IT, LU, NO, RO, SE, SI and UK.
Maltese: Il-prodott ġie sussegwentement approvat f'AT, BE, DE, DK, EE, ES, FI, HR, IE, IT, LU, NO, RO, SE, SI u UK.
English: J Clin Oncol 1993;11:374-377 2 Johnson DH, Hainsworth JD, Hande KR, et al. Cancer 1999;67:231
Maltese: Bioavailability of Low-Dose Oral Etoposide. J Clin Oncol 1993;11:374-377 Johnson DH, Hainsworth JD, Hande KR, et al.
English: 8 Inoue, A. et al, Pharmacokinetic analysis of combination chemotherapy with carboplatin and etoposide in small-cell lung cancer patients undergoing hemodialysis.
Maltese: et al, Pharmacokinetic analysis of combination chemotherapy with carboplatin and etoposide in small-cell lung cancer patients undergoing hemodialysis.
English: 9 Guideline on risk assessment of medicinal products on human reproduction and lactation: from data to labelling
Maltese: Oncol. 15, 51-54 (2004)]. 9 Guideline on risk assessment of medicinal products on human reproduction and lactation: from data to labelling
English: Vepesid is available as 50mg and 100 mg capsules for oral use.
Maltese: Vepesid jiġi bħala kapsuli 50 mg u 100 mg għal użu orali.
English: - Hodgkin's lymphoma
Maltese: - Linfoma ta' Hodgkin
English: In renal impairment (creatinine clearance (CrCl) 15-5 mL/min) a dose reduction of 25% is recommended.
Maltese: F'indeboliment renali (tneħħija tal-kreatinina (CrCl) 15-5 mL/min) huwa rakkomandat tnaqqis fiddoża ta' 25 %.
English: Based on data on bioavailability[1][2], the recommended oral dose is 100 to 200 mg/m2/day on day 1-5 in a cycle of 21 or 28 days; or 200 mg/m2/day on three days (most often days 1-3 or day 1, 3, and 5) in a cycle of 21 or 28 days.
Maltese: Abbażi tad-dejta dwar il-bijodisponibbiltà[1][2], id-doża orali rakkomandata hija ta' 100 sa 200 mg/m2/jum f'jum 1-5 f'ċiklu ta' 21 jew 28 jum; jew ta' 200 mg/m2/jum fuq tlitt ijiem (ħafna drabi jiem 1-3 jew jum 1, 3 u 5) f'ċiklu ta' 21 jew 28 jum.
English: In patients with renal impairment, the CHMP agreed not to recommend a dose reduction when creatinine clearance is > 50 mL/min as supported by available literature[3][4][5][6][7].
Maltese: F'pazjenti b'indeboliment renali, is-CHMP qabel li ma jirrakkomandax tnaqqis fid-doża meta ttneħħija tal-kreatinina tkun > 50 mL/min kif appoġġjat minn letteratura disponibbli [3][4][5][6][7].
English: Vepesid and associated names was included in the list of products for summary of product characteristics (SmPC) harmonisation, drawn up by the CMDh, in accordance with Article 30(2) of Directive 2001/83/EC.
Maltese: Vepesid u l-ismijiet assoċjati ġew inklużi fil-lista ta' prodotti għall-armonizzazzjoni tas-sommarju tal-karatteristiċi tal-prodott (SmPC), imfassal mis-CMDh, skont l-Artikolu 30(2) tadDirettiva 2001/83/KE.
English: - Acute myeloid leukaemia
Maltese: - Lewkimja majelojde akuta
English: The MAH also discussed a dose reduction for patients with end stage renal disease (CrCl < 15mL/min).
Maltese: L-MAH iddiskuta wkoll tnaqqis fid-doża għal pazjenti b'mard renali tal-aħħar fażi (CrCl < 15 mL/min).
English: The first European approval was in NL on 29 May 1981.
Maltese: L-ewwel approvazzjoni Ewropea kienet f'NL fid-29 ta' Mejju 1981.
English: The pregnancy section has been revised in line with the relevant guideline[9].
Maltese: Is-sezzjoni tat-tqala ġiet riveduta f'konformità mal-linja gwida rilevanti[9].
English: The following special warnings and precautions for use have been harmonised in section 4.4 where they were already included in some or most of the national SmPCs: within-patient variability, myelosuppression, secondary leukaemia, hypersensitivity, injection site reaction, low serum albumin, impaired renal and hepatic function, tumour lysis syndrome and mutagenic potential.
Maltese: It-twissijiet speċjali u prekawzjonijiet għall-użu li ġejjin ġew armonizzati fis-sezzjoni 4.4 fejn dawn diġà kienu inklużi f'xi jew ħafna mill-SmPCs nazzjonali: varjabbiltà fil-pazjenti, majelosoppressjoni, lewkimja sekondarja, sensittività eċċessiva, reazzjoni fis-sit tal-injezzjoni, albumina fis-seru baxxa, funzjoni renali u epatika indebolita, sindrome ta' lijasi tat-tumur u potenzjal mutaġeniku.
English: 3 Kreusser W, Herrmann R, Tschope W, et al. Nephrological complications of cancer therapy.
Maltese: 3 Kreusser W, Herrmann R, Tschope W, et al.
English: The coefficient of variation is around 30% for oral administration, versus 10% for intravenous administration (between-patient variability is similar after intravenous or oral administration, i.e. 30-40%).
Maltese: Il-koeffiċjent talvarjazzjoni huwa madwar 30 % għal għoti orali, kontra 10 % għal għoti ġol-vini (il-varjabbiltà bejn il-pazjenti hija simili wara għoti ġol-vini jew orali, jiġifieri 30-40 %).
English: 1 Hande KR, Krozely MG, Greco FA et al. Bioavailability of Low-Dose Oral Etoposide.
Maltese: 1 Hande KR, Krozely MG, Greco FA et al.
English: 7 Fissell WH, IV, Earl M. Pharmacokinetics of Anti-cancer Chemotherapy in Renal Insufficiency and Dialysis.
Maltese: Pharmacokinetics of Anti-cancer Chemotherapy in Renal Insufficiency and Dialysis.
English: - Ovarian cancer: non-epithelial ovarian cancer and platinum-resistant/refractory epithelial ovarian cancer
Maltese: - Kanċer tal-ovarji: kanċer tal-ovarji mhux epiteljali u kanċer tal-ovarji epiteljali reżistenti għall-platinu/refrattarju
English: 4 Arbuck SG, Douglass HO, Crom WR et al. Etoposide Pharmacokinetics in Patients With Normal and Abnormal Organ
Maltese: 4 Arbuck SG, Douglass HO, Crom WR et al.
English: The revised indications in section 4.1 of the Summary of Product Characteristics (SmPC) are:
Maltese: L-indikazzjonijiet reveduti fis-sezzjoni 4.1 tas-Sommarju tal-Karatteristiċi tal-Prodott (SmPC) huma:
English: • The scope of the referral was the harmonisation of the product information,
Maltese: • Il-kamp ta' applikazzjoni tar-riferiment kien l-armonizzazzjoni tal-informazzjoni dwar ilprodott,
English: • The product information proposed by the Marketing Authorisation Holders has been assessed based on the documentation submitted and the scientific discussion within the Committee,
Maltese: • L-informazzjoni dwar il-prodott proposta mid-Detenturi tal-Awtorizzazzjoni għat-Tqegħid fis-Suq ġiet evalwata abbażi tad-dokumentazzjoni ppreżentata u d-diskussjoni xjentifika fi ħdan il-Kumitat,
English: Vepesid contains etoposide, a semi-synthetic derivative of podophyllotoxin which ruptures double strand DNA by means of an interaction with DNA-topoisomerase II, or by the formation of free radicals.
Maltese: Vepesid fih etoposide, derivattiv semisintetiku ta' podophyllotoxin li jkisser DNA b'filament doppju permezz ta' interazzjoni ma' DNA-topoisomerase II, jew permezz tal-formazzjoni ta' radikali ħfief.
English: - Recurrent or refractory testicular cancer
Maltese: - Kanċer tat-testikoli rikorrenti jew refrattarju