FrancophonIA/ELRC3.0 huggingface dataset:
English: Although antiemetic properties have been observed for 7-OH-granisetron and indazoline N-desmethyl granisetron, it is unlikely that these contribute significantly to the pharmacological activity of granisetron in man.
Maltese: Għalkemm kienu osservati kwalitajiet kontra r-rimettar għal 7-OH-granisetron u għal indazoline N-desmethyl granisetron, huwa improbabbli li dawn jikkontribwixxu b'mod sinifikanti għall-attività farmakoloġika ta' granisetron fil-bniedem.
English: LIST OF EXCIPIENTS Lactose monohydrate See the leaflet for further information.
Maltese: LISTA TA' SUSTANZI MHUX ATTIVI Lactose monohydrate
English: Serotonin is the main neurotransmitter responsible for emesis after chemo- or radio-therapy.
Maltese: Serotonin huwa n-newrotrasmettitur prinċipali responsabbli għar-rimettar wara kimo jew radjuterapija.
English: HOW TO TAKE KYTRIL
Maltese: X'fih Kytril
English: Kytril and associated names (see Annex I) 1 mg/1 ml solution for injection Kytril and associated names (see Annex I) 3 mg/3 ml solution for injection Kytril and associated names (see Annex I) 3 mg/1 ml solution for injection Kytril and associated names (see Annex I) 3 mg/5 ml solution for injection
Maltese: Kytril u ismijiet assoċjati (ara Anness I) 1 mg/1 ml soluzzjoni għall-injezzjoni Kytril u ismijiet assoċjati (ara Anness I) 3 mg/3 ml soluzzjoni għall-injezzjoni Kytril u ismijiet assoċjati (ara Anness I) 3 mg/1 ml soluzzjoni għall-injezzjoni Kytril u ismijiet assoċjati (ara Anness I) 3 mg/5 ml soluzzjoni għall-injezzjoni [Ara Anness I - Biex timtela mill-pajjiż partikolari]
English: The steroid will be given either as a dose between 8 and 20 mg dexamethasone before your radioor chemotherapy or as 250 mg methyl-prednisolone, which will be given both before and after your radio- or chemotherapy.
Maltese: Listerojd se jingħata bħala doża ta' bejn 8 u 20 mg ta' dexamethasone qabel ir-radju- jew kimoterapija tiegħek jew bħala 250 mg ta' methyl-prednisolone, li se jingħata kemm qabel kif ukoll wara r-radju- jew kimoterapija tiegħek.
English: Although QT-prolongation has been observed with 5-HT3 receptor antagonists (see section 4.4), this effect is of such occurrence and magnitude that it does not bear clinical significance in normal subjects.
Maltese: Għalkemm kien osservat titwil ta' QT b'antagonisti tar-riċetturi ta' 5-HT3 (ara sezzjoni 4.4), dan leffett huwa ta' okkorrenza u qawwa li ma jkollux sinifikat kliniku f'individwi normali.
English: Preclinical data revealed no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, reproductive toxicity and genotoxicity.
Maltese: Dejta qabel l-użu kliniku ibbażata fuq studji konvenzjonali ta' sigurtà farmakoloġika, effett tossiku minn dożi ripetuti, effett tossiku fuq is-sistema riproduttiva u effett tossiku fuq il-ġeni, ma żvelat lebda periklu speċjali għall-bnedmin.
English: Granisetron is a potent anti-emetic and highly selective antagonist of 5-hydroxytryptamine (5-HT3) receptors.
Maltese: Granisetron huwa antagonist qawwi kontra t-tqalligħ u selettiv ħafna għar-riċetturi ta' 5-hydroxytryptamine (5-HT3).
English: A dose of 1 mg (10 g/kg) of Kytril solution for injection should be administered by slow intravenous injection.
Maltese: Doża ta' 1 mg (10 g/kg) ta' Kytril soluzzjoni għall-injezzjoni għandha tingħata permezz ta' injezzjoni bil-mod fil-vini.
English: • have heart problems, are being treated for cancer with a medicine that is known to damage your heart or have problems with levels of salts, such as potassium, sodium or calcium, in your body (electrolyte abnormalities)
Maltese: • għandek problemi fil-qalb, qed tiġi kkurat għall-kanċer b'mediċina magħrufa li tagħmel ħsara lill-qalb jew għandek problemi bil-livelli ta' melħ, bħal potassju, sodju jew kalċju, fil-ġisem tiegħek (anormalitajiet fl-elettroliti)
English: Administration may be as either a slow intravenous injection (over 30 seconds) or as an intravenous infusion diluted in 20 to 50 ml infusion fluid and administered over 5 minutes.
Maltese: L-għoti jista' jkun bħala injezzjoni bil-mod fil-vini (fuq medda ta' 30 sekonda) jew bħala infużjoni fil-vini dilwita f'20 sa 50 ml ta' fluwidu għall-infużjoni u mogħtija fuq medda ta' 5 minuti.
English: In patients with severe renal failure, data indicate that pharmacokinetic parameters after a single intravenous dose are generally similar to those in normal subjects.
Maltese: F'pazjenti b'insuffiċjenza renali severa, dejta tindika li l-parametri farmakokinetiċi wara doża waħda fil-vini huma ġeneralment simili għal dawk f'individwi normali.
English: WHAT KYTRIL IS AND WHAT IT IS USED FOR Kytril contains a medicine called granisetron.
Maltese: Kytril fih mediċina msejħa granisetron.
English: As for other 5-HT3 antagonists, ECG changes including QT interval prolongation have been reported with granisetron.
Maltese: Bħal b'antagonisti oħra ta' 5-HT3, kienu rrappurtati każijiet ta' modifiki fl-ECG inkluż titwil f'intervall QT b'granisetron.
English: Each film-coated tablet contains 2 mg granisetron (as hydrochloride).
Maltese: Kull pillola miksija b'rita fiha 2 mg granisetron (bħala hydrochloride).
English: Interaction with neurotropic and other active substances through its activity on P 450-cytochrome has been reported (see section 4.5).
Maltese: Kienet irrappurtata interazzjoni ma' newrotopiċi u ma' sustanzi attivi oħra permezz tal-attività tiegħu fuq iċ-ċitokromju P 450 (ara sezzjoni 4.5).
English: This belongs to a group of medicines called ‘5-HT3 receptor antagonists' or ‘anti-emetics'.
Maltese: Din tagħmel parti minn grupp ta' mediċini msejħa ‘antagonisti tar-riċetturi ta' 5-HT3' jew ‘anti-emetiċi'.
English: The vomiting centre is located in the brainstem medullary structures.
Maltese: Iċ-ċentru ta' rimettar jinstab fl-istrutturi medullari tal-brainstem.
English: Each ml solution for injection contains 0.6 mg granisetron (as hydrochloride).
Maltese: Kull ml ta' soluzzjoni għall-injezzjoni fiha 0.6 mg ta' granisetron (bħala hydrochloride).
English: A dose of 1-3 mg (10-40 g/kg) of Kytril solution for injection should be administered either as a slow intravenous injection or as a diluted intravenous infusion 5 minutes prior to the start of chemotherapy.
Maltese: Doża ta' 1-3 mg (10-40 g/kg) ta' Kytril soluzzjoni għall-injezzjoni għandha tingħata bħala injezzjoni bil-mod fil-vini jew bħala infużjoni dilwita fil-vini fuq medda ta' 5 minuti.
English: A study in cloned human cardiac ion channels has shown that granisetron has the potential to affect cardiac repolarisation via blockade of HERG potassium channels.
Maltese: Studju fuq kanali tal-joni tal-qalb umani ikklonati wera li granisetron għandu l-potenzjal li jaffettwa il-polarizzazzjoni mill-ġdid tal-qalb permezz ta' imblokk tal-kanali HERG tal-potassju.
English: In the case of overdose with the tablets, symptomatic treatment should be given.
Maltese: F'każ ta' doża eċċessiva bil-pilloli, għandha tingħata kura sintomatika.
English: The dose will usually be either one or two 1 mg tablets or one 2 mg tablet once a day, but your doctor may decide to increase your dose to upto nine 1 mg tablets a day.
Maltese: Id-doża normalment tkun pillola waħda jew żewġ pilloli ta' 1 mg jew pillola waħda ta' 2 mg darba kuljum, iżda t-tabib tiegħek jista' jiddeċiedi li jżid id-doża tiegħek sa disa' pilloli ta' 1 mg kuljum.
English: Each film-coated tablet contains 1 mg granisetron (as hydrochloride).
Maltese: Kull pillola miksija b'rita fiha 1 mg granisetron (bħala hydrochloride).
English: HOW TO STORE KYTRIL
Maltese: Jekk tinsa tieħu Kytril
English: • skin rashes or an allergic skin reaction or “nettle-rash” or “hives” (urticaria).
Maltese: • raxx fil-ġilda jew reazzjoni allerġika fil-ġilda jew “raxx bil-ponot” jew “ħorriqija” (urtikarja).
English: Kytril film-coated tablets are indicated in adults for prevention of delayed nausea and vomiting associated with chemotherapy and radiotherapy.
Maltese: Kytril pilloli miksija b'rita huma indikati fl-adulti għall-prevenzjoni ta' tqalligħ u rimettar ittardjat assoċjat ma' kimoterapija u radjuterapija.
English: Batch
Maltese: Tfal
English: • changes in the heartbeat (rhythm) and changes seen on ECG readings (electrical recordings of the heart)
Maltese: • bidliet fir-rata ta' taħbit tal-qalb (ritmu) u bidliet osservati fil-qari tal-ECG (reġistrazzjonijiet elettriċi tal-qalb)
English: Each ml solution for injection contains 0.6 mg of granisetron (as the hydrochloride).
Maltese: Kull ml ta' soluzzjoni għall-injezzjoni fih 0.6 mg granisetron (bħala hydrochloride).
English: The chemoreceptor trigger zones are located at the caudal end of the fourth ventricle (area postrema).
Maltese: It-trigger zones ta' kimoriċetturi jinstabu fittarf t'isfel tar-raba' ventrikolu (area postrema).
English: The solution for injection should not be use after the expiry date which is stated on the carton and/or ampoule after EXP.
Maltese: Tużax is-soluzzjoni għall-injezzjoni wara d-data ta' skadenza li tidher fuq il-kartuna u/jew ampulla wara EXP.
English: Kytril and associated names (see Annex I) 1 mg film-coated tablets Kytril and associated names (see Annex I) 2 mg film-coated tablets
Maltese: Kytril u ismijiet assoċjati (ara Anness I) 1 mg pilloli miksija b'rita Kytril u ismijiet assoċjati (ara Anness I) 2 mg pilloli miksija b'rita
English: The effect of the injection may be improved by the use of medicines called adrenocortical steroids.
Maltese: L-effett tal-injezzjoni jista' jkun imtejjeb bl-użu ta' mediċini li jissejħu sterojdi adrenokortikali.
English: The following table of listed adverse reactions is derived from clinical trials and post-marketing data associated with Kytril and other 5-HT3 antagonists.
Maltese: It-tabella ta' reazzjonijiet avversi li ġejja hija derivata minn provi kliniċi u dejta miksuba wara ttqegħid fis-suq assoċjati ma' Kytril u antagonisti oħra ta' 5-HT3.
English: Take special care with Kytril
Maltese: Oqgħod attent ħafna b' Kytril
English: Neurological mechanisms, serotonin-mediated nausea and vomiting
Maltese: Mekkaniżmi newroloġiċi, tqalligħ u rimettar ikkawżati minn serotonin
English: The maximum dose of Kytril to be administered over 24 hours should not exceed 3 mg.
Maltese: Id-doża massima ta' Kytril li għandha tingħata fuq medda ta' 24 siegħa m'għandiex taqbeż 3 mg.
English: Each ml solution for injection contains 3 mg granisetron (as hydrochloride).
Maltese: Kull ml ta' soluzzjoni għall-injezzjoni fih 3 mg granisetron (bħala hydrochloride).
English: Doses of up to 38.5 mg of Kytril as a single injection have been reported, with symptoms of mild headache but no other reported sequelae.
Maltese: Kienu rrappurtati dożi sa 38.5 mg ta' Kytril bħala injezzjoni waħda, b'sintomi ta' wġigħ ta' ras ħafif iżda bl-ebda rapport ta' konsegwenzi oħra.
English: Each ml solution for injection contains 3 mg of granisetron (as hydrochloride).
Maltese: Kull ml ta' soluzzjoni għall-injezzjoni fiha 3 mg ta' granisetron (bħala hydrochloride).
English: Granisetron administered orally has been shown to be effective for prevention and treatment of post-operative nausea and vomiting in adults.
Maltese: Granisetron mogħti b'mod orali intwera li huwa effettiv għall-prevenzjoni u l-kura ta' tqalligħ u rimettar wara operazzjoni fl-adulti.
English: • medicines used to treat an irregular heartbeat other ‘5-HT3 receptor antagonist' medicines such as dolasetron or ondansetron (see “Take special care with Kytril” above)
Maltese: mediċini użati biex jikkuraw tħabbit irregolari tal-qalb, mediċini oħra ‘antagonisti tar-riċetturi ta' 5-HT3' bħal dolasetron jew ondansetron (ara “Oqgħod attent ħafna b'Kytril” fuq)
English: Granisetron Intravenous use
Maltese: Is-sustanza attiva hi granisetron
English: There is insufficient clinical evidence to recommend administration of the solution for injection to children in prevention and treatment of Post-operative nausea and vomiting (PONV).
Maltese: M'hemmx evidenza klinika biżżejjed biex jiġi rrakkomandat l-għoti ta' soluzzjoni għall-injezzjoni lit-tfal fil-prevenzjoni u l-kura ta' Tqalligħ u rimettar wara operazzjoni (PONV).
English: 6.2 Incompatibilities [To be completed nationally]
Maltese: .2 Inkompatibilitajiet [Biex timtela mill-pajjiż partikolari]
English: 1 mg twice a day or 2 mg once a day for up to one week following radiotherapy or chemotherapy.
Maltese: 1 mg darbtejn kuljum jew 2 mg darba kuljum sa ġimgħa wara radjuterapija jew kimoterapija.
English: NAME OF THE MEDICINAL PRODUCT Kytril and associated names (see Annex I) 1 mg film-coated tablets Kytril and associated names (see Annex I) 2 mg film-coated tablets [See Annex I - To be completed nationally] Granisetron
Maltese: Kytril u ismijiet assoċjati (ara Anness I) 1 mg pilloli miksija b'rita Kytril u ismijiet assoċjati (ara Anness I) 2 mg pilloli miksija b'rita [Ara Anness I - Biex timtela mill-pajjiż partikolari] Granisetron
English: Nonetheless it is advisable to monitor both ECG and clinical abnormalities when treating patients concurrently with drugs known to prolong the QT (see section 4.5).
Maltese: Madankollu huwa rrakkomandat li jiġu ssorveljati kemm l-anormalitajiet tal-ECG kif ukoll dawk kliniċi meta jiġu kkurati pazjenti li qed jirċievu mediċini magħrufa li jtawlu QT fl-istess waqt (ara sezzjoni 4.5).
English: Each ml solution for injection contains 1 mg granisetron (as hydrochloride).
Maltese: Kull ml ta' soluzzjoni għall-injezzjoni fih 1 mg granisetron (bħala hydrochloride).
English: Although ketaconazole was shown to inhibit the ring oxidation of granisetron in vitro, this action is not considered clinically relevant.
Maltese: Jekk iseħħu xi bidliet, dawn ġeneralment ikunu mingħajr sinifikat kliniku.
English: The most Kytril you will be given is 3 mg a day.
Maltese: L-għola doża ta' Kytril li se tingħata hija ta' 3 mg kuljum.
English: What Kytril looks like and contents of the pack Ampoules - [To be completed nationally]
Maltese: Id-Dehra ta' Kytril u l-kontenuti tal-pakkett Ampulli - [Biex timtela mill-pajjiż partikolari]
English: Total control of postoperative nausea and vomiting during the first 2 hours after surgery was observed in most patients.
Maltese: Fil-maġġoranza tal-pazjenti kien osservat kontroll totali ta' tqalligħ u rimettar ta' wara operazzjoni fl-ewwel sagħtejn wara l-kirurġija.
English: Each ml solution for injection contains 1 mg of granisetron (as hydrochloride).
Maltese: Kull ml ta' soluzzjoni għall-injezzjoni fiha 1 mg ta' granisetron (bħala hydrochloride).
English: What Kytril is and what it is used for Before you are given Kytril How Kytril will be given Possible side effects How to store Kytril Further information
Maltese: Bħal kull mediċina oħra, Kytril jista' jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
English: QT prolongation
Maltese: KIF JINGĦATA
English: In patients concurrently treated with medicinal products known to prolong QT interval and/or which are arrhythmogenic, this may lead to clinical consequences (see section 4.4).
Maltese: F'pazjenti li qed jiġu kkurati wkoll bi prodotti mediċinali magħrufa li jtawlu lintervall QT u/jew li jistgħu jikkawżaw arritmija, dan jista' jwassal għal konsegwenzi kliniċi (ara sezzjoni 4.4).
English: Additionally, granisetron has not shown any apparent medicinal product interaction with emetogenic cancer chemotherapies.
Maltese: Barra minn hekk, granisetron ma wera l-ebda interazzjoni evidenti tal-prodott mediċinali ma' kimoterapiji emetoġeniċi tal-kanċer.
English: The remainder is excreted in faeces as metabolites.
Maltese: Il-bqija jitneħħa bħala metaboliti fl-ippurgar.
English: Film-coated tablet.
Maltese: Disturbi fil-fwied u fil-marrara
English: It receives major inputs from the chemoreceptor trigger zones, and a vagal and sympathetic input from the gut.
Maltese: Dan jirċievi informazzjoni maġġuri minn trigger zones ta' kimoriċetturi, u informazzjoni vagali u simpatetika mill-musrana.
English: Following exposure to radiation or catotoxic substances, serotonin (5-HT) is released from enterochromaffine cells in the small intestinal mucosa, which are adjacent to the vagal afferent neurons on which 5-HT3 receptors are located.
Maltese: Wara esponiment għal radjazzjoni jew sustanzi katotossiċi, serotonin (5-HT) jintreħa minn ċelluli enterochromaffine fil-mukuża tal-musrana ż-żgħira, li huma maġenb in-newroni vagali li jwasslu għall-moħħ li fuqhom jinstabu r-riċetturi ta' 5-HT3.
English: EMA/34440/2016 EMEA/H/C/002578
Maltese: EMA/H/C/002578
English: It is available as capsules (5, 10, 20, 30, 40 and 60 mg) to be taken by mouth on an empty stomach, at least two hours after the evening meal.
Maltese: Jiġi bħala kapsuli (5, 10, 20, 30, 40 u 60 mg) li għandhom jittieħdu mill-ħalq fuq stonku vojt, mill-inqas sagħtejn wara l-ikla ta' filgħaxija.
English: On average, the patients' LDL cholesterol levels were reduced by 40%.
Maltese: Bħala medja, il-livelli tal-kolesterol LDL tal-pazjenti tnaqqsu b'40%.
English: This is a summary of the European public assessment report (EPAR) for Lojuxta.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Lojuxta.
English: Lojuxta is a medicine that contains the active substance lomitapide.
Maltese: Lojuxta huwa mediċina li fiha s-sustanza attiva lomitapide.
English: The most common side effects are problems with the gut, which may affect as many as 9 out of 10 people: diarrhoea and nausea (feeling sick) were each seen in around 7 out of 10 people, dyspepsia (heartburn) and vomiting were each seen in more than 3 out of 10 people, while pain, discomfort and bloating of the abdomen (belly), constipation and flatulence were each seen in at least 2 out of 10 people.
Maltese: L-effetti sekondarji l-aktar komuni huma problemi fl-imsaren, li jistgħu jaffettwaw sa 9 persuni minn kull 10: dijarea u nawżja (tħossok ma tiflaħx) kull waħda dehret f'madwar 7 persuni minn kull 10, dispepsija (ħruq ta' stonku) u remetter kull waħda dehret f'aktar minn 3 persuni minn kull 10, filwaqt li wġigħ, skumdità u nefħa tal-addome (iż-żaqq), stitikezza u gass kull waħda dehret f'mill-inqas żewġ persuni f'kull 10.
English: Other information about Lojuxta
Maltese: Informazzjoni oħra dwar Lojuxta
English: The active substance in Lojuxta, lomitapide, blocks the action of a substance in the body called ‘microsomal triglyceride transfer protein', which is present in the cells of the liver and the gut.
Maltese: Is-sustanza attiva f'Lojuxta, il-lomitapide, timblokka l-azzjoni ta' sustanza fil-ġisem msejħa ‘proteina tat-trasferiment mikrosomali tat-trigliċeridi', li hija preżenti fiċ-ċelloli tal-fwied u tal-imsaren.
English: The CHMP considered that the medicine's effect in reducing LDL cholesterol levels was a benefit for patients with homozygous familial hypercholesterolaemia, who have an unmet medical need.
Maltese: Is-CHMP ikkunsidra li l-effett tal-mediċina fit-tnaqqis tal-livelli tal-kolesterol LDL kien ta' benefiċċju għallpazjenti b'iperkolesterolemija omozigota familjali, li għandhom ħtieġa medika mhux sodisfatta.
English: Why is Lojuxta approved?
Maltese: Għaliex ġie approvat Lojuxta?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Lojuxta on 31 July 2013.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Lojuxta fil-31 ta' Lulju 2013.
English: The benefits of Lojuxta in reducing blood cholesterol were assessed in a main study involving 29 patients with homozygous familial hypercholesterolaemia.
Maltese: Il-benefiċċji ta' Lojuxta fit-tnaqqis tal-kolesterol fid-demm kienu evalwati fi studju ewlieni li fih ħadu sehem 29 pazjent b'iperkolesterolemija omozigota familjali.
English: It is used to treat adult patients with homozygous familial hypercholesterolaemia, an inherited disease causing high blood levels of cholesterol (a type of fat).
Maltese: Jintuża fil-kura ta' pazjenti adulti b'iperkolesterolemija omozigota familjali, marda li tintiret li tikkawża livelli għolja ta' kolesterol (tip ta' xaħam) fid-demm.
English: What are the risks associated with Lojuxta?
Maltese: X'inhuma r-riskji assoċjati ma' Lojuxta?
English: What information is still awaited for Lojuxta?
Maltese: Liema informazzjoni għadha mistennija għal Lojuxta?
English: The main measure of effectiveness was the change in the patients' blood levels of ‘low density lipoprotein' (LDL) cholesterol, commonly known as ‘bad cholesterol', after 26 weeks of treatment.
Maltese: Ilkejl ewlieni tal-effikaċja kien il-bidla fil-livelli tal-kolesterol ta' ‘lipoproteina ta' densità baxxa' (LDL) fiddemm tal-pazjenti, magħruf b'mod komuni bħala ‘kolesterol ħażin', wara 26 ġimgħa ta' kura.
English: The full EPAR for Lojuxta 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 Għal aktar informazzjoni dwar il-kura b'Lojuxta, aqra lfuljett ta' tagħrif (parti wkoll mill-EPAR) jew ikkuntattjat lit-tabib jew lill-ispiżjar tiegħek.
English: For further information, see the package leaflet.
Maltese: Lojuxta kien awtorizzat taħt ‘ċirkustanzi ta' eċċezzjoni'.
English: Lojuxta must not be used together with over 40 mg per day of simvastatin (another medicine used to lower blood cholesterol levels) or with certain other medicines that affect the way lomitapide is broken down in the body.
Maltese: Lojuxta m'għandux jintuża flimkien ma' aktar minn 40 mg kuljum ta' simvastatin (mediċina oħra użata biex tbaxxi l-livelli tal-kolesterol fiddemm) jew ma' ċerti mediċini oħra li jaffettwaw il-mod kif il-lomitapide titkisser fil-ġisem.
English: By blocking this protein, Lojuxta decreases the level of fats released into the blood, thereby helping to reduce the level of cholesterol in hypercholesterolaemia.
Maltese: Billi jimblokka din il-proteina, Lojuxta jnaqqas il-livell ta' xaħmijiet rilaxxati fid-demm, u b'hekk jgħin biex inaqqas il-livell ta' kolesterol fl-iperkolesterolemija.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Lojuxta, including the appropriate precautions to be followed by healthcare professionals and patients.
Maltese: Se jinkludi wkoll materjal edukattiv li għandu jingħata lill-pazjenti, inkluż fuljett u skeda ta' twissija .
English: Since Lojuxta has been approved under exceptional circumstances, the company that markets the medicine is carrying out a long-term study in patients taking Lojuxta to provide further data on its safety and effectiveness, including its side effects on the liver, stomach, gut, and cardiovascular system.
Maltese: Peress li Lojuxta ġie approvat taħt ċirkostanzi ta' eċċezzjoni, il-kumpanija li tqiegħed il-mediċina fis-suq qed twettaq studju fit-tul fuq pazjenti li jkunu qed jieħdu Lojuxta biex tipprovdi aktar data dwar issigurtà u l-effikaċja tiegħu, inkluż l-effetti sekondarji tiegħu fuq il-fwied, l-istonku, l-imsaren, u ssistema kardjovaskulari.
English: In addition, the company that markets Lojuxta will provide educational materials to all doctors expected to prescribe Lojuxta, containing information on how to select suitable patients as well as key safety information, including side effects, interactions with other medicines and use in women who could potentially have children.
Maltese: Barra minn hekk, il-kumpanija li tqiegħed Lojuxta fis-suq se tipprovdi materjal edukattiv lit-tobba kollha li huma mistennija li jippreskrivu Lojuxta, li jkun fih informazzjoni dwar kif jagħżlu pazjenti xierqa kif ukoll informazzjoni ewlenija dwar is-sigurtà, inkluż effetti sekondarji, interazzjonijiet ma' mediċini oħra u użu f'nisa li potenzjalment jista' jkollhom it-tfal.
English: Treatment should begin at a dose of 5 mg once per day, and if well tolerated may be steadily increased to a maximum dose of 60 mg per day.
Maltese: Il-kura għandha tinbeda b'doża ta' 5 mg darba kuljum, u jekk tiġi ttollerata tajjeb tista' tiżdied b'mod stabbli għal doża massima ta' 60 mg kuljum.