FrancophonIA/ELRC3.0 huggingface dataset:
English: The CHMP reviewed the results of laboratory studies looking at the way that controlled-release systems act when they are placed in solutions containing alcohol.
Maltese: Is-CHMP irreveda r-riżultati minn studji fil-laboratorju li ħarsu lejn il-mod ta' kif sistemi b'rilaxx ikkontrollat jaġixxu meta jitqiegħdu f'soluzzjonijiet li fihom l-alkoħol.
English: This means that almost a full day's dose of morphine would be released all at once if a patient were to take the capsule with large drink of neat strong liquor, such as whisky or vodka.
Maltese: Dan ifisser li kważi d-doża kollha ta' morfina ta' ġurnata sħiħa tkun ġiet rilaxxata f'daqqa kieku l-pazjent kellu jieħu l-kapsula ma' xarba kbira ta' likur pur qawwi, bħal whisky jew vodka.
English: Modifiedrelease tablets and capsules are made by combining the active substance with other substances that
Maltese: Pilloli u kapsuli b'rilaxx modifikat huma magħmulin billi jikkombinaw is-sustanza attiva ma' sustanzi oħra li
English: The CHMP noted that the use of this medicine in combination with alcohol is already contra-indicated.
Maltese: Is-CHMP innota li l-użu ta' din il-mediċina f'kombinazzjoni mal-alkoħol huwa diġà kontra-indikat.
English: • Prescribers of modified-release opioids and their patients should be aware of the potential interaction between these medicines and alcohol.
Maltese: • It-tobba li jippreskrivu l-opioids b'rilaxx modifikat u l-pazjenti tagħhom għandhom ikunu konxji talinterazzjoni potenzjali bejn dawn il-mediċini u l-alkoħol.
English: What are modified-release oral medicines of the WHO level III scale for the management of pain?
Maltese: X'inhuma mediċini orali b'rilaxx modifikat tal-iskala ta' livell III tal-WHO għall-ġestjoni tal-uġigħ?
English: The European Medicines Agency has completed a review of the safety and effectiveness of modifiedrelease oral opioid medicines of the WHO level III scale for the management of pain.
Maltese: L-Aġenzija Ewropea tal-Mediċini temmet reviżjoni tas-sigurtà u l-effikaċja tal-mediċini opjojdi orali b'rilaxx modifikat tal-iskala ta' livell III tal-WHO għall-ġestjoni tal-uġigħ tad-WHO.
English: Companies responses provided on: 25 January 2010, 4 May 2010 and 2 July 2010 Opinion date:
Maltese: Il-Kummissjoni Ewropea ħarġet deċiżjoni fl-20 ta' April 2011.
English: The CHMP also took information from studies looking at the drinking habits of patients with severe pain into account.
Maltese: Is-CHMP qies ukoll informazzjoni minn studji li ħarsu lejn id-drawwiet tax-xorb ta' pazjenti b'uġigħ qawwi.
English: Jean-Louis Robert (quality, non-biologicals) and Barbara van Zwieten-Boot (the Netherlands)
Maltese: jinħallu bil-mod fil-ġisem jew li jillimitaw ir-rilaxx tas-sustanza attiva, bħal sustanzi u polimeri bbażati fuq iċ-ċelluloża.
English: However, for modified-release medicines that contain a ‘polymethacrylate-triethylcitrate controlled release system', the Committee concluded that the marketing authorisations should be suspended.
Maltese: Madankollu, għall-mediċini b'rilaxx modifikat li fihom ‘sistema b'rilaxx ikkontrollat ta' polymethacrylatetriethylcitrate', il-Kumitat ikkonkluda li l-awtorizzazzjonijiet għat-tqegħid fis-suq għandhom jiġu sospiżi.
English: Oral opioid medicines of the WHO level III scale for the management of pain are strong painkillers that are taken by mouth and used to treat intense pain that has not been controlled sufficiently with other medicines.
Maltese: Mediċini opjojdi orali tal-iskala ta' livell III tal-WHO għall-ġestjoni tal-uġigħ huma analġeżiċi qawwija li jittieħdu mill-ħalq u wżati fil-kura ta' uġigħ qawwi li ma jkun ġie ikkontrollat biżżejjed b'mediċini oħra.
English: Therefore, the CHMP concluded that modified-release opioids using the polymethacrylate-triethylcitrate controlled-release system are highly sensitive to alcohol and that there is a risk of dose dumping if patients drink alcohol while taking them.
Maltese: Minħabba li xi wħud mill-kimiċi wżati fis-sistemi ta' rilaxx ikkontrollat idubu fl-alkoħol, hemm possibbiltà teoretika li meta tieħu dawn il-mediċini flimkien malalkoħol, dan jista' jġiegħel lis-sustanza attiva sabiex din tiġi rilaxxata wisq malajr.
English: These are called ‘controlled-release systems'.
Maltese: Dawn jissejħu ‘sistemi ta' rilaxx ikkontrollat'.
English: They include morphine and the related medicines oxycodone and hydromorphone, all of which work by attaching to receptors in the brain and spinal cord to prevent pain.
Maltese: Huma jinkludu l-morfina u l-mediċini relatati oxycodone u hydromorphone, li kollha jaħdmu billi jeħlu ma' riċetturi fil-moħħ u fl-ispina dorsali biex jevitaw l-uġigħ.
English: Questions and answers on the review of modified-release oral opioid medicines of the WHO level III scale for the management of pain
Maltese: Mistoqsijiet u tweġibiet dwar ir-reviżjoni ta' mediċini opjojdi orali b'rilaxx modifikat tal-iskala ta' livell III talWHO għall-ġestjoni tal-uġigħ
English: They are called ‘WHO level III scale' medicines as they are on the highest step of the World Health Organization's three-step pain relief ladder.
Maltese: Huma jissejħu mediċini ‘fuq livell III tal-liskala tal-WHO' għaliex qegħdin fuq l-ogħla skala tal-sellum bi tliet tarġiet ta' serħan mill-uġigħ talOrganizzazzjoni Dinjija tas-Saħħa.
English: The CHMP concluded that around half of the controlled-release systems tested showed a slight increase in the amount of active substance they released when placed in an alcohol solution, but that this effect was mild and would only have a minor effect on the release of the active substance.
Maltese: Is-CHMP ikkonkluda li madwar nofs is-sistemi b'rilaxx ikkontrollat li ġew ittestjati wrew żieda żgħira flammont ta' sustanza attiva li rrilaxxaw meta tqiegħdu f'soluzzjoni tal-alkoħol, iżda li dan l-effett kien ħafif u kien sejjer ikollu effett minuri biss fuq ir-rilaxx tas-sustanza attiva.
English: Member State in EEA
Maltese: Stat Membru EU/EEA
English: Human Medicines Evaluation Division
Maltese: Lista ta' prodotti mediċinali u preżentazzjonijiet
English: Meda Pharma Gmbh & Co. Kg
Maltese: Meda Pharma Gmbh & Co.
English: Ratiopharm Gmbh Flupirtinmaleat Ratiopharm
Maltese: Flupirtinmaleat Ratiopharm
English: Farmacêuticos, S.A.
Maltese: Meda Pharma - Produtos Farmacêuticos, S.A.
English: Meda PharmaProdutos
Maltese: Għamla farmaċewtika
English: INN + Strength
Maltese: INN + Qawwa
English: Flupirtinmaleat Tamarang
Maltese: Flupirtinmaleat Tamarang Flupirtine Maleate 100mg Kapsula
English: Hormosan Pharma Gmbh
Maltese: Ratiopharm Gmbh
English: This plan shall consist of measures aiming to minimise adverse events associated with the intravitreal injection procedure (e.g. endophthalmitis) through adequate education about: a) The intravitreal procedure as it was performed in the pivotal clinical studies b) Sterile techniques to minimize risk of infection c) Use of antibiotics d) Use of povidone iodine e) Performing lid scrubs f) Use of anesthetic to ensure patient comfort g) Techniques for the intravitreal injection h) Management of intraocular pressure (IOP) i) Management of endophthalmitis j) Understanding the risk factors involved in developing endophthalmitis k) Reporting of serious adverse events
Maltese: L-użu ta' l-antibijotiċi d) L-użu ta' povidone iodine e) It-tindif metikoluż tal-għotjien f) L-użu ta' anestetiku biex tkun żgurata l-kumdità tal-pazjent g) Proċeduri għall-injezzjoni intravitreali h) Il-ġestjoni tal-pressjoni ta' ġol-għajn (IOP) i) Il-ġestjoni ta' l-endoftalmite j) Spjegazzjoni tal-fatturi tar-riskju involuti fl-iżvilupp ta' l-endoftalmite k)
English: ¾ The Member States must ensure that the education plans for physicians, health care providers, and patients contain the measures a) to m) as detailed below, and are suitable for the purpose of minimising adverse events associated with the intravitreal injection procedure (e.g. endophthalmitis) prior to marketing.
Maltese: Il-pjan irid ikun jikkonsisti minn miżuri immirati għat-tnaqqis ta' episodji sekondarji assoċjati mal-proċedura ta' l-injezzjoni intravitreali (eż. l-endoftalmite) permezz ta' edukazzjoni xierqa dwar: a) Il-proċedura intravitreali kif imwettqa fl-istudji kliniċi kruċjali b) Tekniċi sterili għat-tnaqqis tar-riskju ta' l-infezzjoni c)
English: • An educational plan for physicians and health care providers which is aimed at risk minimisation and to support safe and effective use for the product.
Maltese: • Pjan edukattiv għall-pazjenti li jkun immirat għat-tnaqqis tar-riskji u għall-appoġġ ta' l-użu sigur u effettiv għall-prodott.
English: This plan shall consist of measures to provide adequate education on: l) Key signs and symptoms of serious adverse events associated with the intravitreal injection procedure m) When to seek urgent attention from the health care provider
Maltese: Il-pjan irid jinkludi miżuri biex tingħata edukazzjoni xierqa dwar: l) Sinjali u sintomi ta' episodji sekondarji serji assoċjati mal-proċeduri ta' l-injezzjoni intravitreali m) Meta jkun hemm bżonn li tinkiseb attenzjoni urġenti minn dawk involuti fil-kura tas-saħħa
English: EU/1/17/1176
Maltese: EU/1/17/1176/001 Yargesa
English: 84 x 1 capsules (unit dose)
Maltese: 84 x 1 kapsula (doża waħda)
English: 100 mg Capsule, hard Oral use blister (PVC/ PCTFE/Alu)
Maltese: Użu orali nuffata (PVC/ PCTFE/alu)
English: EMA Number
Maltese: Numru tal-EMA
English: Yargesa
Maltese: Isem (ivvintat)
English: It should be given under qualified medical supervision.
Maltese: Jingħata taħt superviżjoni medika kwalifikata.
English: It contains the active substance basiliximab.
Maltese: Fih is-sustanza attiva basiliximab.
English: The marketing authorisation was renewed on 9 October 2003 and on 9 October 2008.
Maltese: L-awtorizzazzjoni għat-tqegħid fis-suq ġiet imġedda fid-9 ta' Ottubru 2003 u fid-9 ta' Ottubru 2008.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) SIMULECT EPAR summary for the public
Maltese: RAPPORT TA' VALUTAZZJONI PUBBLIKA EWROPEW (EPAR) SIMULECT Sommarju tal-EPAR għall-pubbliku
English: In adults, the most common side effects (seen in more than 20% of patients) were constipation, urinary tract infections (infection of the structures that carry urine), pain, nausea (feeling sick), peripheral oedema (swelling), hypertension (high blood pressure), anaemia (low red blood cell counts), headache, hyperkalaemia (high blood potassium levels), hypercholesterolaemia (high blood cholesterol levels), surgical wound complication, weight increase, increased serum creatinine (a marker of kidney problems), hypophosphataemia (low blood phosphate levels), diarrhoea and upper respiratory tract infection (colds).
Maltese: Fl-adulti, l-iktar effetti sekondarji komuni (li dehru f'iktar minn 20% tal-pazjenti) kienu l-istitikezza, infezzjonijiet fil-pajp tal-awrina (fl-istrutturi li tgħaddi minnhom l-awrina), uġigħ, nawżea (dardir), edema periferali (nefħa), pressjoni għolja, anemija (livelli baxxi ta' ċelloli tad-demm ħomor), uġigħ ta' ras, iperkalemija (livelli għoljin ta' potassju fid-demm), iperkolesterolemija (livelli għolja ta' kolesterol fid-demm), kumplikazzjonijiet filferiti tal-operazzjoni, żieda fil-piż, żieda fil-livell tal-kreatinina (markatur tal-problemi tal-kliewi), ipofosfatemija (livelli baxxi ta' fosfat fid-demm), dijarrea u infezzjonijiet fil-pajpijiet tan-nifs ta' fuq (irjiħat).
English: The active substance in Simulect, basiliximab, is a monoclonal antibody.
Maltese: Is-sustanza attiva f'Simulect, basiliximab, hija antikorp monoklonali.
English: In the third study, all 345 adults were taking ciclosporin, steroids and azathioprine (‘triple therapy').
Maltese: Fit-tielet studju, it-345 adult kollha kienu qed jieħdu ciclosporin, sterojdi u azathioprine (‘terapija tripla').
English: In adults and children weighing more than 35 kg, the recommended total dose is 40 mg, given as two 20 mg doses.
Maltese: Fl-adulti u fit-tfal li jiżnu iktar minn 35 kg, id-doża totali rakkomandata hija ta' 40 mg, mogħtija f'żewġ dożi ta' 20 mg.
English: This summary was last updated in 10-2008.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar fi: 10-2008.
English: Simulect is used in combination with other medicines used to prevent organ rejection, such as ciclosporin, corticosteroids, azathioprine and mycophenolate mofetil.
Maltese: Simulect jintuża flimkien ma' mediċini oħra għallprevenzjoni tar-riġettar tal-organi, bħas-ciclosporin, kortikosterojdi, azathioprine u mycophenolate mofetil.
English: In children weighing less than 35 kg, it is 20 mg, given as two 10 mg doses.
Maltese: Fit-tfal li jiżnu inqas minn 35 kg, id-doża hija ta' 20 mg, mogħtija f'żewġ dożi ta' 10 mg.
English: Simulect has been assessed in three main studies involving a total of 1,067 adults who were having a kidney transplant.
Maltese: Simulect ġie vvalutat fi tliet studji ewlenin li fihom b'kollox ħadu sehem 1,067 adult li kienu ngħataw trapjant tal-kilwa.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Simulect to Novartis Europharm Limited on 9 October 1998.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida madwar l-Unjoni Ewropea, għal Simulect lil Novartis Europharm Limited fid-9 ta' Ottubru 1998.
English: Simulect is given into a vein, either as a ‘bolus' injection (given all at once) or as an infusion over 20 to 30 minutes.
Maltese: Simulect jingħata fil-vina, jew bħala injezzjoni ‘bolus'(mogħtija kollha f'daqqa) jew bħala infużjoni li ddum bejn 20 u 30 minuta.
English: CD25 is a receptor for the messenger interleukin-2, which stimulates the T-lymphocytes to divide.
Maltese: CD25 huwa riċettur għall-messaġġier interleukin-2, li jistimula l-limfoċiti-T biex jinqasmu.
English: All three studies compared the effectiveness of Simulect with that of placebo (a dummy treatment).
Maltese: It-tliet studji qabblu l-effikaċja ta' Simulect ma' dik ta' plaċebo (trattament finta).
English: What is Simulect?
Maltese: X'inhu Simulect?
English: Looking at the results of the first two studies taken together, 40% of the patients receiving Simulect in addition to dual therapy failed treatment over six months (145 out of 363), compared with 56% of the patients receiving placebo (201 out of 359).
Maltese: Ħarsa lejn ir-riżultati tal-ewwel żewġ studji meħudin flimkien turi li 40% tal-pazjent li ngħataw Simulect flimkien ma' terapija doppja fallew it-trattament fis-sitt xhur ta' wara (145 minn 363) meta mqabbla ma'56% tal-pazjenti li ngħataw il-plaċebo (201 minn 359).
English: In the third study, fewer patients receiving Simulect with triple therapy failed treatment (26%) than those receiving placebo (40%).
Maltese: Fit-tielet studju, kien hemm inqas pazjenti (26%) li fallew it-trattament meta ngħataw Simulect flimkien ma' terapija trippla meta mqabbla ma' dawk li ngħataw plaċebo (40%).
English: What is the risk associated with Simulect?
Maltese: X'inhu r-riskju assoċjat ma' Simulect?
English: In children, the side effects seen in more than 20% of patients were urinary tract infections, hypertrichosis (excess body hair), rhinitis (stuffy and runny nose), pyrexia (fever), hypertension, upper respiratory tract infection, viral infection, sepsis (blood infection) and constipation.
Maltese: Fit-tfal, l-effetti sekondarji li dehru f'iktar minn 20% tal-pazjenti kienu l-infezzjonijiet filpajp tal-awrina, ipertrikożi (xagħar tal-ġisem żejjed), rinite (imnieħer irritat u bil-flissjoni), piressija (deni), pressjoni għolja, infezzjonijiet fil-pajpijiet ta' fuq tan-nifs, infezzjonijiet virali, sepsis (infezzjoni fid-demm) u stitikezza.
English: If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).
Maltese: Jekk trid aktar informazzjoni abbażi tar-rakkomandazzjonijiet tas-CHMP, aqra dDiskussjoni Xjentifika (ukoll parti mill-EPAR).
English: Basiliximab has been designed to target an antigen called CD25, which is present on the surface of T-lymphocytes (a type of white blood cell that is involved in the rejection of organ transplants).
Maltese: Basiliximab ġie mfassal biex jaħdem fuq antiġen magħruf bħala CD25, li jinstab fuq il-wiċċ tal-limfoċiti-T (tip ta' ċelloli tad-demm bojod li għandhom x'jaqsmu mar-riġettar tat-trapjant tal-organi).
English: Simulect is given as two injections.
Maltese: Simulect jingħata f'żewġ injezzjonijiet.
English: How has Simulect been studied?
Maltese: Kif ġie studjat Simulect?
English: By binding to CD25, basiliximab blocks the activity of interleukin-2, reducing the rate at which the lymphocytes multiply.
Maltese: Billi jeħel ma' CD25, basiliximab jimblokka l-attività ta' interleukin-2, inaqqas ir-rata li biha l-limfoċiti jimmultiplikaw.
English: Other information about Simulect:
Maltese: Aktar tagħrif dwar Simulect:
English: Why has Simulect been approved?
Maltese: Għaliex ġie approvat Simulect?
English: Simulect should only be prescribed and given by a doctor who has experience in the use of immunosuppressive treatment following an organ transplant.
Maltese: Simulect għandu jiġi preskritt u mogħti biss minn tabib bl-esperjenza fl-użu tat-trattament immunosuppressiv wara trapjant tal-organi.
English: A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and bind to a specific structure (called an antigen) that is found on certain cells in the body.
Maltese: Antikorp monoklonali jfisser antikorp (tip ta' proteina) imfassal biex jagħraf u jeħel ma' struttura speċifika (magħrufa bħala antiġen) li tinstab fuq ċerti ċelloli fil-ġisem.
English: How is Simulect used?
Maltese: Għal xiex jintuża Simulect?
English: Simulect was more effective than placebo.
Maltese: Simulect kien iktar effikaċi mill-plaċebo.
English: In the first two studies, most of the 722 patients were also taking ciclosporin and corticosteroids (‘dual therapy'), with some patients also taking azathioprine or mycophenolate mofetil.
Maltese: Fl-ewwel żewġ studji, il-biċċa l-kbira tas-722 pazjent kienu qed jieħdu wkoll ciclosporin u kortikosterojdi (‘terapija doppja'), b'xi pazjenti jieħdu wkoll azathioprine jew mycophenolate mofetil.
English: The Committee for Medicinal Products for Human Use (CHMP) decided that Simulect's benefits are greater than its risks for the prophylaxis of acute organ rejection in de novo allogeneic renal transplantation in adult and paediatric patients.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (is-CHMP) iddeċieda li l-benefiċċji ta' Simulect huma ikbar mir-riskji tiegħu għall-profilassi ta' riġettar akut tal-organi trapjantati f'pazjenti adulti u tfal li jkunu għadhom kemm ħadu trapjant alloġeniku ta' kilwa.
English: For the full list of all side effects reported with Simulect, see the Package Leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji rrappurtati ma' Simulect, ara l-Fuljett ta' Tagħrif.
English: Simulect is a powder and solvent that are made up into a solution for injection or infusion (drip into a vein).
Maltese: Simulect huwa trab u solvent li jitħalltu f'soluzzjoni għall-injezzjoni jew infużjoni (dripp fil-vina).
English: This reduces the number of activated T-lymphocytes, lowering the risk of the transplant being rejected.
Maltese: Dan inaqqas l-għadd ta' limfoċiti-T attivati, u jnaqqas ir-riskju li l-organi trapjantati jiġu riġettati.
English: It is available as tablets (500 mg).
Maltese: Jiġi bħala pilloli (500 mg).
English: The full EPAR for Lysodren 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: Lysodren is a medicine that contains the active substance mitotane.
Maltese: Lysodren huwa mediċina li fiha s-sustanza attiva mitotane.
English: The summary of opinion of the Committee for Orphan Medicinal Products for Lysodren can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Maltese: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: The levels of the active substance in the blood should be monitored frequently, with the final target dose aiming to reach blood levels between 14 and 20 mg per litre.
Maltese: Il-livelli tas-sustanza attiva fid-demm għandhom jiġu mmonitorjati b'mod frekwenti, bid-doża finali fil-mira tipprova tilħaq livelli tad-demm ta' bejn 14 u 20 mg għal kull litru.
English: The most common side effects with Lysodren (seen in more than 1 patient in 10) are increased blood levels of liver enzymes, cholesterol and triglycerides (a type of fat), leucopenia (low white blood cell counts), prolonged bleeding time, ataxia (difficulty co-ordinating movements), paraesthesia (abnormal sensations like pins and needles), vertigo (a spinning sensation), sleepiness, mucositis (inflammation of the mucous membranes, such as the lining of the mouth), vomiting, diarrhoea, nausea (feeling sick), epigastric discomfort (discomfort around the stomach), skin rash, myasthenia (muscle weakness), adrenal insufficiency (reduced adrenal gland activity), loss of appetite, asthenia (weakness), gynaecomastia (breast enlargement) and confusion.
Maltese: L-effetti sekondarji l-aktar komuni b'Lysodren (dehru f'aktar minn 1 minn kull 10 pazjenti) huma żieda fl-enzimi tal-fwied, kolesterol, u trigliċeridi (tip ta' xaħam) fil-livelli tad-demm, lewkopenija (livelli baxxi ta' ċelloli bojod tad-demm), ħin itwal ta' fsada, atassja (diffikultà biex tikkoordina l-movimenti), parasteżija (sensazzjonijiet anormali bħal tingiż), vertiġini (sens ta' tidwir), ngħas, mukożite
English: This is a summary of the European public assessment report (EPAR) for Lysodren.
Maltese: Dan id-dokument huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Lysodren.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Lysodren on 28 April 2004.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Lysodren valida fl-Unjoni Ewropea kollha fit-28 ta' April 2004.
English: Lysodren is used to treat the symptoms of advanced adrenal cortical carcinoma (cancer of the outer layer of the adrenal gland).
Maltese: Lysodren jintuża sabiex jiġu ttrattati s-sintomi ta' karċinoma avvanzata tal-kortiċi adrenali (kanċer tassaff ta' barra tal-glandola adrenali).
English: There is limited information on the use of Lysodren in children, but a daily starting dose of 1.5 to 3.5 g per square metre body surface area (calculated using the child's height and weight) is recommended.
Maltese: Hemm informazzjoni limitata dwar l-użu ta' Lysodren fit-tfal, iżda doża inizjali fil-ġurnata ta' 1.5 sa 3.5 grammi għal kull metru kwadru tas-superfiċje tal-ġisem (ikkalkulata billi jintużaw it-tul u l-piż tattifel/tifla) hija rakkomandata.
English: The cortex of the adrenal gland produces steroid hormones.
Maltese: Il-kortiċi tal-glandola adrenali jiżviluppa ormoni tal-isterojdi.
English: Why has Lysodren been approved?
Maltese: Għaliex ġie approvat Lysodren?
English: Because the number of patients with adrenal cortical carcinoma is low, the disease is considered ‘rare', and Lysodren was designated an ‘orphan medicine' (a medicine used in rare diseases) on 12 June
Maltese: Minħabba li n-numru ta' pazjenti b'karċinoma fil-kortiċi adrenali baxx, il-marda hija kkunsidrata ‘rari', u Lysodren ġie kklassifikat bħala ‘mediċina orfni' (mediċina użata f'mard rari) fit-12 ta' Ġunju 2002.
English: A starting dose of 4 to 6 g per day can be used in patients who need urgent control of Cushing's syndrome (a set of symptoms of adrenal gland cancer caused by high hormone levels).
Maltese: Doża inizjali ta' 4 sa 6 grammi fil-ġurnata tista' tintuża f'pazjenti li jeħtieġu kontroll urġenti tas-sindromu ta' Cushing (sett ta' sintomi ta' kanċer tal-glandola adrenali kkawżati minn livelli għolja ta' ormoni).
English: Levels above 20 mg/l may cause severe side effects without increasing the medicine's effectiveness.
Maltese: Livelli 'l fuq minn 20 mg/l jistgħu jikkawżaw effetti sekondarji mingħajr ma tiġi miżjuda l-effikaċja talmediċina.