FrancophonIA/ELRC3.0 huggingface dataset:
English: Silapo 6 000 IU/0.6 ml solution for injection in pre-filled syringe Epoetin zeta
Maltese: IU/0.6 ml Soluzzjoni għall-injezzjoni f'siringa mimlija minn qabel Epoetin zeta
English: Silapo 5 000 IU/0.5 ml solution for injection in pre-filled syringe 1 pre-filled syringe with 0.5 ml solution for injection contains 5 000 international units (IU) epoetin zeta* (recombinant human erythropoietin).
Maltese: IU/0.5 ml soluzzjoni għall-injezzjoni f'siringa mimlija minn qabel Siringa waħda mimlija minn qabel b'0.5 ml soluzzjoni għall-injezzjoni għandha 5 000 unit internazzjonali (IU) epoetin zeta* (rikombinanti uman erythropoietin).
English: After initiation of therapy, your doctor will maintain your haemoglobin level between 10 and 12 g/dl
Maltese: Wara li tinbeda t-terapija, it-tabib tiegħek ser iżomm il-livell tal-emoglobina tiegħek bejn 10 u 12 g/dl.
English: Silapo 20 000 IU/0.5 ml solution for injection in pre-filled syringe 1 pre-filled syringe with 0.5 ml solution for injection contains 20 000 international units (IU) epoetin zeta* (recombinant human erythropoietin).
Maltese: IU/0.5 ml soluzzjoni għall-injezzjoni f'siringa mimlija minn qabel Siringa waħda mimlija minn qabel b'0.5 ml soluzzjoni għall-injezzjoni għandha 20 000 unit internazzjonali (IU) epoetin zeta* (rikombinanti uman erythropoietin).
English: Silapo 1 000 IU/0.3 ml solution for injection in pre-filled syringe 1 pre-filled syringe with 0.3 ml solution for injection contains 1 000 international units (IU) epoetin zeta* (recombinant human erythropoietin).
Maltese: IU/0.3 ml soluzzjoni għall-injezzjoni f'siringa mimlija minn qabel Siringa waħda mimlija minn qabel b'0.3 ml soluzzjoni għall-injezzjoni għandha 1 000 unit internazzjonali (IU) epoetin zeta* (rikombinanti uman erythropoietin).
English: Silapo 10 000 IU/1 ml solution for injection in pre-filled syringe 1 pre-filled syringe with 1 ml solution for injection contains 10 000 international units (IU) epoetin zeta* (recombinant human erythropoietin).
Maltese: Silapo 10 000 IU/1 ml soluzzjoni għall-injezzjoni f'siringa mimlija minn qabel Siringa waħda mimlija minn qabel b'1 ml soluzzjoni għall-injezzjoni għandha 10 000 unit internazzjonali (IU) epoetin zeta* (rikombinanti uman erythropoietin).
English: Serious skin rashes including Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported in association with epoetin treatment.
Maltese: Kien hemm rapporti ta' raxxijiet serji tal-ġilda fosthom is-sindrome ta' Stevens-Johnson u nekroliżi epidermali tossika b'rabta ma' kura b'epoetini.
English: A sustained haemoglobin level of greater than 12 g/dl (7.5 mmol/l) should be avoided; guidance for appropriate dose adjustment for when haemoglobin values exceeding 12 g/dl (7.5 mmol/l) are observed are described below.
Maltese: Livell sostnut ta' emoglobina ta' mhux aktar minn 12 g/dl (7.5 mmol/l) għandu jiġi evitat; gwida għal aġġustament tad-doża għal meta l-valuri tal-emoglobina jaqbżu 12 g/dl (7.5 mmol/l) jiġu osservati huma deskritti hawn isfel.
English: As an increased incidence of thrombotic vascular events (TVEs) has been observed in cancer patients receiving erythropoietic agents (see section 4.8), this risk should be carefully weighed against the benefit to be derived from treatment (with Silapo) particularly in cancer patients with an increased risk of thrombotic vascular events, such as obesity and patients with a prior history of TVEs (e.g. deep venous thrombosis or pulmonary embolism).
Maltese: Minħabba l-inċidenza aktar għolja ta' ġrajjiet trombotiċi vaskulari (TVEs) li ġiet osservata f'pazjenti tal-kanċer li qegħdin jirċievu l-aġenti tal-eritropojetin (ara sezzjoni 4.8), dan ir-riskju għandu jitqies kontra l-benefiċċju li għandu jittieħed mit-trattament (b'Silapo) speċjalment f'pazjenti tal-kanċer b'żieda fir-riskju fil-ġrajjiet trombotiċi vaskulari, bħalma huma l-obeżità u pazjenti bi storja ta' TVEs (eż. trombożi venuża fonda jew emboliżmu pulmonarju).
English: Use in adult patients in an autologous predonation programme The recommended starting dose is 600 IU/kg.
Maltese: L-użu f'pazjenti adulti f'programm ta' predonazzjoni awto-anologu Id-doża rrakkomandata tal-bidu hija ta' 600
English: Silapo 5 000 IU/0.5 ml solution for injection in pre-filled syringe Epoetin zeta
Maltese: IU/0.5 ml Soluzzjoni għall-injezzjoni f'siringa mimlija minn qabel Epoetin zeta
English: Silapo 1 000 IU/0.3 ml solution for injection in pre-filled syringe EU/1/07/432/001
Maltese: IU/0.3 ml soluzzjoni għall-injezzjoni f'siringa mimlija minn qabel EU/1/07/432/001
English: Generally, children and adolescents under 30 kg body weight require higher maintenance doses than adults and children over 30 kg.
Maltese: Ġeneralment, fit-tfal u fl-adolexxenti b'piż ta' anqas minn 30 kg għandhom bżonn dożi ogħla ta' manteniment minn tfal ta' aktar minn 30 kg u adulti.
English: Silapo 20 000 IU/0.5 ml solution for injection in pre-filled syringe EU/1/07/432/017
Maltese: IU/0.5 ml soluzzjoni għall-injezzjoni f'siringa mimlija minn qabel EU/1/07/432/017
English: Haemoglobin levels should be monitored regularly.
Maltese: M'hemmx studji adegwati u kontrollati tajjeb f'nisa tqal.
English: Epoetins are not approved in the management of anaemia associated with hepatitis C.
Maltese: L-epoetini mhumiex approvati biex jiġġestixxu anemija assoċjata ma' epatite Ċ.
English: Excipient with known effect Each pre-filled syringe contains 0.15 mg phenylalanine.
Maltese: Dan il-prodott mediċinali fiha sa 0.5 mg phenylalanine f'kull doża.
English: The treatment is divided into two stages: 1.
Maltese: It-trattament huwa maqsum f'żewġ stadji: 1.
English: Silapo 2 000 IU/0.6 ml solution for injection in pre-filled syringe 1 pre-filled syringe with 0.6 ml solution for injection contains 2 000 international units (IU) epoetin zeta (recombinant human erythropoietin).
Maltese: IU/0.6 ml soluzzjoni għall-injezzjoni f'siringa mimlija minn qabel Siringa waħda mimlija minn qabel b'0.6 ml soluzzjoni għall-injezzjoni fiha 2 000 unità internazzjonali (IU) ta' l-epoetin zeta (rikombinant uman eritroptejin).
English: Treatment of patients with chemotherapy induced anaemia
Maltese: Trattament ta' pazjenti għal anemija sensitizzata bil-kimoterapija
English: Diarrhoea, Nausea, Vomiting
Maltese: Dijarea, Dardir, Remettar
English: How to use Silapo
Maltese: X'fih Silapo
English: Use should be restricted to patients with moderate anaemia (e.g. haemoglobin concentration range between 10 to 13 g/dl) who do not have an autologous predonation programme available and with expected moderate blood loss (900 to 1 800 ml).
Maltese: L-użu għandu jkun ristrett għal pazjenti b'anemija moderata (eż. medda ta' konċentrazzjoni ta' emoglobina bejn 10 u 13 g/dl) li ma jkollhomx programm ta' predonazzjoni awtologu disponibbli u li jkun mistenni li jkun hemm telf moderat ta' demm (900 sa 1 800 ml).
English: Maintenance dose between
Maltese: Tqala u treddigħ
English: A paradoxical decrease in haemoglobin and development of severe anaemia associated with low reticulocyte counts should prompt to discontinue treatment with epoetin and perform antierythropoietin antibody testing.
Maltese: Tnaqqis paradossali fl-emoglobina u l-iżvilupp ta' anemija severa assoċjata ma għadd żgħir ta' retikuloċiti għandhom iqanqlu l-waqfien tat-trattament b'epoetin u testijiet ta' antikorpi kontra l-eritropojetin.
English: Use in adult patients receiving haemodialysis Your doctor will maintain your haemoglobin concentration between 10 and 12 g/dl (6.2 - 7.5 mmol/l).
Maltese: L-użu f'pazjenti adulti li qegħdin jirċievu l-emodijalisi It-tabib tiegħek ser iżomm il-konċentrazzjoni tal-emoglobina bejn 10 u 12 g/dl (6.2 - 7.5 mmol/l)
English: Silapo 2 000 IU/0.6 ml solution for injection in pre-filled syringe EU/1/07/432/003
Maltese: IU/0.6 ml soluzzjoni għall-injezzjoni f'siringa mimlija minn qabel EU/1/07/432/003
English: In clinical trials, an increased risk of death, serious cardiovascular events or cerebrovascular events including stroke were observed when ESAs were administered to target a haemoglobin of greater than 12 g/dl (7.5 mmol/l).
Maltese: Fi provi kliniċi, riskju ogħla ta' mewt u każijiet kardjovaskulari serji, każijiet ċerebrovaskulari li jinkludu puplesija kienu osservati meta sustanzi li jistimulaw l-eritropojesi (ESAs) ġew mogħtija sabiex jintlaħaq livell ta' emoglobina li hu ogħla minn 12 g/dl (7.5 mmol/l).
English: EMA/465284/2015 EMEA/H/C/000704
Maltese: EMEA/H/C/000704
English: Increlex mecasermin
Maltese: Increlex mekasermina
English: This summary was last updated in 05-2015.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar fi: 05-2015.
English: The full EPAR for Increlex 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: The active substance in Increlex, mecasermin, is a copy of the hormone IGF-1.
Maltese: Is-sustanza attiva f'Increlex, il-mekasermina, hija kopja tal-ormon IGF-1.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Increlex can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Maltese: Is-sommarju tal-opinjoni tal-Kumitat għall-Prodotti Mediċinali Orfni għal Increlex jinstab fis-sit web talAġenzija: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: Why has Increlex been approved?
Maltese: Għal xiex ġie approvat Increlex?
English: The recommended starting dose is 0.04 mg per kilogram body weight twice a day.
Maltese: Id-doża tal-bidu rrakkomandata hija 0.04 mg kull kilogramm tal-piż tal-ġisem darbtejn kuljum.
English: Because the number of patients with primary IGF-1 deficiency is low, the disease is considered ‘rare', and Increlex was designated an ‘orphan medicine' (a medicine used in rare diseases) on 22 May 2006.
Maltese: Minħabba li n-numru ta' pazjenti b'defiċjenza primarja ta' IGF-1 huwa wieħed baxx, il-marda hija meqjusa bħala ‘rari' u fit-22 ta' Mejju 2006, Increlex ġie kkategorizzat bħala ‘mediċina orfni' (mediċina użata f'mard rari).
English: This is a summary of the European public assessment report (EPAR) for Increlex.
Maltese: Dan id-dokument huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Increlex.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Increlex on 3 August 2007.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Increlex valida fl-Unjoni Ewropea kollha fit-3 ta' Awwissu 2007.
English: The most common side effects with Increlex (seen in more than 1 patient in 10) are headache, hypoglycaemia (low blood sugar levels), vomiting (being sick), injection site hypertrophy (lumps at the site of injection) and otitis media (infection of the middle ear).
Maltese: L-effetti sekondarji l-aktar komuni b'Increlex (li dehru f'iktar minn pazjent 1 minn 10) huma l-uġigħ ta' ras, l-ipogliċemija (livelli baxxi ta' zokkor fid-demm), remettar (tħossok ma tiflaħx), ipertrofija fis-sit tal-injezzjoni (boċċi fis-sit tal-injezzjoni) u otite medja (infezzjoni fil-widna minn ġewwa).
English: The maximum dose is 0.12 mg per kilogram twice a day.
Maltese: 12 mg għal kull kilogramm tal-piż tal-ġisem darbtejn kuljum.
English: Increlex has been studied in five studies involving a total of 76 children aged between one and 15 years with severe primary IGF-1 deficiency, nine of whom had received another type of recombinant IGF-1 before joining these studies.
Maltese: Increlex ġie studjat f'ħames studji li involvew total ta' 76 tifel u tifla ta' 'etajiet bejn sena u 15-il sena b'defiċjenza primarja ta' IGF-1 serja, disgħa minnhom irċevew tip ieħor ta' IGF-1 rikombinanti qabel ma daħlu f'dawn l-istudji.
English: Increlex is a solution for injection that contains the active substance mecasermin.
Maltese: Increlex hu soluzzjoni għall-injezzjoni li fiha s-sustanza attiva mekasermina.
English: This increased to 8.0 cm in the first year of treatment and 5.8 cm in the second.
Maltese: Din żdiedet għal 8.0 cm fl-ewwel sena talkura u 5.8 cm fit-tieni.
English: Other information about Increlex
Maltese: X'inhu Increlex?
English: Increlex is used for the long-term treatment of patients aged two to 18 years who are short for their age due to a condition known as ‘severe primary insulin-like growth factor-1 deficiency'.
Maltese: Increlex jintuża għal kura fit-tul ta' pazjenti li għandhom bejn sentejn u 18-il sena li huma qosra għalletà tagħhom minħabba kundizzjoni magħrufa bħala ‘defiċjenza primarja serja tal-fattur -1 tal-iżvilupp bħall-insulina'.
English: A risk management plan has been developed to ensure that Increlex is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiżgura li Increlex jintuża bl-aktar mod sigur possibbli.
English: IGF-1 is important in determining how tall a child grows.
Maltese: IGF-1 huwa importanti biex jiddetermina kemm j/tikber fit-tul tifel jew tifla.
English: What measures are being taken to ensure the safe and effective use of Increlex?
Maltese: X'miżuri qed jitteħdu biex jassiguraw l-użu sigur u effikaċi ta' Increlex?
English: For the full list of all side effects and restrictions with Increlex, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet kollha b'Increlex, ara l-fuljett ta' tagħrif.
English: The CHMP decided that Increlex's benefits are greater than its risks and recommended that it be given marketing authorisation.
Maltese: Is-CHMP iddeċieda li l-benefiċċji ta' Increlex huma akbar mir-riskji tiegħu u rrakkomanda li jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: Increlex has been authorised under ‘Exceptional Circumstances'.
Maltese: Increlex ġie awtorizzat taħt “Ċirkostanzi ta' Eċċezzjoni”.
English: How has Increlex been studied?
Maltese: Kif ġie studjat Increlex?
English: What is the risk associated with Increlex?
Maltese: Għal xiex jintuża Increlex?
English: It should never be injected into a vein.
Maltese: Dan qatt m'għandu jiġi injettat ġol-vina.
English: Patients with this condition have low levels of the hormone insulin-like growth factor-1 or IGF-1, which is required for normal growth.
Maltese: Pazjenti b'din il-kundizzjoni għandhom livelli baxxi ta' ormon, fattur-1 tal-iżvilupp bħallinsulina jew IGF-1, li huwa meħtieġ għal żvilupp normali.
English: Increlex must not be used in patients who have, or are thought to have active neoplasia (abnormal cell growth).
Maltese: Increlex m'għandux jintuża f'pazjenti li jkollhom, jew huwa maħsub li għandhom neoplejżia attiva (żvilupp ta' ċelloli anormali).
English: How does Increlex work?
Maltese: X'benefiċċji wera Increlex waqt l-istudji?
English: Further information on Forxiga can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Forxiga.
Maltese: ema.europa.eu/medicines/human/EPAR/Forxiga.
English: Forxiga received a marketing authorisation valid throughout the EU on 11 November 2012.
Maltese: Forxiga ngħata awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fil-11 ta' Novembru 2012.
English: This overview was last updated in 08-2019.
Maltese: Din il-ħarsa ġenerali ġiet aġġornata l-aħħar f'08-2019.
English: Other information about Forxiga
Maltese: Informazzjoni oħra dwar Forxiga
English: Both combinations reduced HbA1c levels by 0.52 percentage points after 52 weeks.
Maltese: Iżżewġ kombinazzjonijiet naqqsu l-livelli ta' HbA1c b'0.52 punti perċentwali wara 52 ġimgħa.
English: Forxiga contains the active substance dapagliflozin.
Maltese: Forxiga fih is-sustanza attiva dapagliflożin.
English: The active substance in Forxiga, dapagliflozin, blocks the action of a protein in the kidneys called sodium-glucose co-transporter 2 (SGLT2).
Maltese: Is-sustanza attiva f'Forxiga, id-dapagliflożin, timblokka l-azzjoni ta' proteina fil-kliewi li tissejjaħ kotrasportatur 2 ta' sodju-glukożju (SGLT2).
English: What are the risks associated with Forxiga?
Maltese: X'inhuma r-riskji assoċjati ma' Forxiga?
English: In four other studies involving 2,370 patients, adding Forxiga to other diabetes medicines decreased HbA1c levels by 0.54-0.68 percentage points more than adding placebo after 24 weeks.
Maltese: F'erba' studji oħra li kienu jinvolvu 2,370 pazjent, iż-żieda ta' Forxiga ma' mediċini oħra kontra d-dijabete naqqset illivelli ta' HbA1c b'0.54-0.68 punti perċentwali iktar milli biż-żieda tal-plaċebo wara 24 ġimgħa.
English: For type 2 diabetes, the dose of Forxiga is 10 mg once a day.
Maltese: Fid-dijabete tat-tip 2, id-doża ta' Forxiga hija ta' 10 mg darba kuljum.
English: The company that markets Forxiga will provide information on precautions to prevent diabetic ketoacidosis in patients with type 1 diabetes, including a patient alert card and guide for patients and their carers, as well as a guide for healthcare professionals, including a prescriber's checklist.
Maltese: Il-kumpanija li tqiegħed Forxiga fis-suq ser tipprovdi informazzjoni dwar il-prekawzjonijiet għallprevenzjoni ta' ketoaċidożi dijabetika f'pazjenti bid-dijabete tat-tip 1, inklużi kard tat-twissija talpazjent u gwida għall-pazjenti u għal dawk li jieħdu ħsiebhom, kif ukoll gwida għall-professjonisti filqasam tal-kura tas-saħħa, inkluża lista ta' kontroll tal-preskrivent.
English: Forxiga is available as tablets (5 and 10 mg) and can only be obtained with a prescription.
Maltese: Forxiga jiġi bħala pilloli (5 u 10 mg) u jista' jinkiseb biss b'riċetta ta' tabib.
English: In two studies involving 1,648 patients with type 1 diabetes whose blood sugar was not controlled well enough on insulin alone, adding Forxiga 5 mg decreased HbA1c levels after 24 hours by 0.37% and by 0.42% more than adding placebo.
Maltese: F'żewġ studji li kienu jinvolvu 1 648 pazjent bid-dijabete tat-tip 1 li z-zokkor fid-demm tagħhom ma kienx ikkontrollat tajjeb biżżejjed bl-insulina waħidha, iż-żieda ta' Forxiga ta' 5 mg naqqset il-livelli ta' HbA1c b'0.37 % wara 24 siegħa u b'0.42 % iktar milli biż-żieda tal-plaċebo.
English: As for all medicines, data on the use of Forxiga are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Forxiga hija ssorveljata kontinwament.
English: A long-term study, involving over 17,000 patients with type 2 diabetes, looked at the effects of dapagliflozin on cardiovascular (heart and circulation) disease.
Maltese: Studju fit-tul, li jinvolvi aktar minn 17,000 pazjent bid-dijabete tat-tip 2, ħares lejn l-effetti ta' dapagliflożin fuq il-mard kardjovaskulari (tal-qalb u taċ-ċirkolazzjoni).
English: In two studies involving 840 patients with type 2 diabetes, Forxiga when used alone decreased HbA1c levels by 0.66 percentage points more than placebo (a dummy treatment) after 24 weeks.
Maltese: F'żewġ studji li kienu jinvolvu 840 pazjent bid-dijabete tat-tip 2, Forxiga meta użat waħdu naqqas illivelli ta' HbA1c b'0.66 punti perċentwali iktar mill-plaċebo (kura finta) wara 24 ġimgħa.
English: The dose is 5 mg once a day and the medicine should be used with precautions to prevent diabetic ketoacidosis (a serious complication of diabetes with high levels of ketones in the blood).
Maltese: Id-doża hija 5 mg darba kuljum u l-mediċina għandha tintuża bi prekawzjonijiet biex tipprevjeni ketoaċidożi dijabetika (komplikazzjoni serja ta' dijabete b'livelli għoljin ta' ketoni fiddemm).
English: Forxiga was found effective in several studies in patients with type 2 and type 1 diabetes.
Maltese: Forxiga nstab li hu effettiv f'diversi studji f'pazjenti bid-dijabete tat-tip 2 u tat-tip 1.
English: In a study involving 814 patients with type 2 diabetes, Forxiga used in combination with metformin was at least as effective as a sulphonylurea (another type of diabetes medicines) used with metformin.
Maltese: Fi studju li kien jinvolvi 814-il pazjent bid-dijabete tat-tip 2, Forxiga użat flimkien ma' metformina kien tal-inqas effettiv daqs sulfonilurea (tip ieħor ta' mediċini kontra d-dijabete) użata ma' metformina.
English: What measures are being taken to ensure the safe and effective use of Forxiga?
Maltese: X'miżuri qegħdin jittieħdu biex jiġi żgurat l-użu sigur u effettiv ta' Forxiga?
English: The most common side effect in patients with type 1 diabetes (which may affect up to 1 in 10 people) is genital infection, especially in women and a common side effect (which may affect up to 1 in 100 people) is diabetic ketoacidosis.
Maltese: L-effett sekondarju l-iktar komuni f'pazjenti bid-dijabete tat-tip 1 (li jista' jaffettwa sa persuna 1 minn 10) huwa infezzjoni ġenitali, speċjalment fin-nisa u effett sekondarju komuni (li jista' jaffettwa sa persuna 1 minn 100) huwa ketoaċidożi dijabetika.
English: For the full list of side effects and restrictions with Forxiga, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet b'Forxiga, ara l-fuljett ta' tagħrif.
English: Side effects reported with Forxiga are carefully evaluated and any necessary action taken to protect patients.
Maltese: L-effetti sekondarji rrappurtati b'Forxiga huma evalwati bir-reqqa u kull azzjoni meħtieġa hi meħuda biex tipproteġi lill-pazjenti.
English: Forxiga is a diabetes medicine used for adults whose condition is not controlled well enough.
Maltese: Forxiga huwa mediċina kontra d-dijabete li tintuża għal adulti li l-kondizzjoni tagħhom mhijiex ikkontrollota tajjeb biżżejjed.
English: In type 1 diabetes, Forxiga is used with insulin in overweight patients (body mass index of at least 27 kg/m2) when insulin on its own does not control blood sugar well enough.
Maltese: Fid-dijabete tat-tip 1, Forxiga jintuża flimkien mal-insulina f'pazjenti b'piż żejjed (indiċi tal-massa talġisem ta' mill-inqas 27 kg/m2) meta l-insulina waħidha ma tikkontrollax tajjeb biżżejjed iz-zokkor fiddemm.
English: Forxiga's common side effects were related to the way the medicine works, such as increased genital and, to a smaller degree, urinary infection, and are considered manageable.
Maltese: L-effetti sekondarji komuni ta' Forxiga kienu relatati mal-mod kif taħdem il-mediċina, bħal żieda flinfezzjoni ġenitali u, f'każijiet limitati, infezzjoni fl-apparat tal-awrina, u jitqiesu maniġġabbli.
English: Precautions have been recommended to reduce the risk of diabetic ketoacidosis and the Agency has asked for further studies to determine its frequency in patients with type 1 diabetes treated with Forxiga.
Maltese: Kienu rakkomandati prekawzjonijiet biex jitnaqqas ir-riskju ta' ketoaċidożi dijabetika u l-Aġenzija talbet aktar studji biex tiġi determinata l-frekwenza tagħha f'pazjenti bid-dijabete tat-tip 1 ikkurati b'Forxiga.
English: Forxiga (dapagliflozin)
Maltese: Kif jintuża Forxiga?
English: The main measure of effectiveness was the level of glycosylated haemoglobin (HbA1c), which gives an indication of how well blood glucose is controlled.
Maltese: Il-kejl ewlieni taleffikaċja kien il-livell ta' emoglobina glikosilata (HbA1c), li tagħti indikazzjoni ta' kemm il-glukożju fiddemm ikun ikkontrollat tajjeb.
English: The risk of muscle toxicity is increased when nicotinic acid is administered concomitantly with a statin (i.e. a 3-hydroxy-3- methylglutaryl coenzyme A [HMGCoA] reductase inhibitor).
Maltese: Ir-riskju ta' tossiċità fil-muskoli jiżdied meta nicotinic acid jingħata flimkien ma' statin (jiġifieri inibitur ta' 3-hydroxy-3- methylglutaryl coenzyme A [HMG-CoA] reductase).
English: Acipimox is structurally related to nicotinic acid.
Maltese: Acipimox huwa strutturalment relatat ma' nicotinic acid.
English: • hypertriglyceridaemia (Fredrickson type IV hyperlipoproteinaemia);
Maltese: • ipertrigliċeridemija (iperlipoproteinemija tat-tip IV ta' Fredrickson); • iperkolesterolemija u ipertrigliċeridemija (iperlipoproteinemija tat-tip IIb ta' Fredrickson).
English: [Product name] capsules prevent the release of fatty acids from fatty tissue and decrease the blood level of triglycerides and cholesterol.
Maltese: [Product name] kapsuli jipprevjenu t-tnixxija ta' aċidi grassi minn tessut xaħmi u jnaqqsu l-livell tattrigliċeridi u l-kolesterol fid-demm.