FrancophonIA/ELRC3.0 huggingface dataset:
English: Uncommon side effects (may affect up to 1 in 100 people) chest pain, changes in electrocardiogram, rapid heart beating decreased or abnormal skin sensibility, pins and needles, attention disturbance, loss of memory, problems with your balance difficulty breathing, cough, nosebleed, throat irritation inflammation of the stomach or mouth, heartburn, retching, dry mouth, discomfort of the abdomen, constipation, belching kidney failure, kidney stones, difficult dischargeof urine, frequent or excessive passage of urine, sometimes at night urticaria, severe swelling of the skin and other tissues (most often the lips or the eyes), eczema, excessive sweating, night sweats, hair loss, acne, scaly skin, colouration of nails muscle pain, muscle cramps or weakness, pain in extremity, osteoporosis slowing down of the thyroid gland function.
Maltese: Effetti sekondarji mhux komuni (jistgħu jaffettwaw sa persuna 1 minn kull 100) uġigħ fis-sider, tibdil fl-elettrokardjogram, qalb tħabbat mgħaġġel - sensibilità fil-ġilda mnaqqsa jew mhuxnormali, tingiż fil-partijiet talġisem minħabba li jorqdu, disturb fl-attenzjoni, telf tal-memorja, problemi bil-bilanċ diffikultà biex tieħu n-nifs, sogħla, tifġir tal-imnieħer, irritazzjoni fil-gerżuma - infjammazzjoni tal-istonku, jew il-ħalq, ħruq ta'stonku, taqligħ, ħalq xott, skonfort tal-addome, stitikezza, tifwieq - falliment tal-kliewi, ġebelfil-kliewi, diffikultà biex tgħaddil-awrina, tgħaddi lawrina b'mod frekwenti jew eċċessiv, xi kultant bil-lejl - urtikarja, nefħa qawwijafil-ġilda u tessuti oħra(l-aktar ix-xufftejn jewlgħajnejn), ekżema, togħroq iż-żejjed, ixoqq l-għaraq bil-lejl, jaqa' x-xagħar, akne, ġilda taqa' qxur qxur, tbajja' fid-dwiefer - uġigħ fil-muskoli, bugħawwieġ jew dgħufija fil-muskoli,uġigħfl-idejnussaqajn, osteoporożi glandola tat-tirojde taħdem aktar bil-mod.
English: Co-administration of darunavir and ritonavir with medicinal products primarily metabolised by CYP2C9 (such as warfarin) and CYP2C19 (such as methadone) may result in decreased systemic exposure to such medicinal products, which could decrease or shorten their therapeutic effect.
Maltese: Lamministrazzjoni ta' darunavir u ritonavir flimkien ma' prodotti mediċinali primarjament immetabolizzati minn CYP2C9 (bħal warfarin) u CYP2C19 (bħal methadone) tista' twassal għal esponiment sistemiku mnaqqas għal dawn il-prodotti mediċinali, li jista' jnaqqas jew iqassar l-effett terapewtiku tagħhom.
English: Darunavir Krka d.d., co-administered with cobicistat is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (HIV-1) infection in adult patients (see section 4.2).
Maltese: Darunavir Krka d.d., mogħti flimkien ma' cobicistat huwa indikat, flimkien ma' prodotti mediċinali antiretrovirali oħra, għall-kura ta' infezzjoni bil-virus talimmunodefiċjenza umana f'pazjenti adulti (ara sezzjoni 4.2).
English: Bottle (HDPE), child resistant temper evident PP closure with a desiccant: - 30 tablets: 1 bottle of 30 film-coated tablets, - 90 tablets: 3 bottles of 30 film-coated tablets.
Maltese: Flixkun (HDPE), għeluq tal-PP reżistenti għat-tbagħbis mit-tfal PP b'dessikant: 30 pillola: flixkun 1 ta' 30 pillola miksijin b'rita, 90 pillola: 3 fliexken ta' 30 pillola miksijin b'rita.
English: 400 mg film-coated tablets are available in bottles containing 30 film-coated tablets (1 bottle of 30 film-coated tablets), 60 film-coated tablets (2 bottles of 30 film-coated tablets), 90 film-coated tablets (3 bottles of 30 film-coated tablets) and 180 film-coated tablets (6 bottles of 30 film-coated tablets) in a box.
Maltese: Darunavir Krka d.d. 400 mg pilloli miksijin b'rita huma disponibbli fi fliexken li fihom 30 pillola miksijin b'rita (flixkun 1 ta' 30 pillola miksijin b'rita), 60 pillola miksijin b'rita (2 fliexken ta' 30 pillola miksjin b'rita), 90 pillola miksijin b'rita (3 fliexken ta' 30 pillola miksjin b'rita) u 180 pillola miksijin b'rita (6 fliexken ta' 30 pillola miksjin b'rita) f'kaxxa.
English: Co-administration of darunavir and ritonavir and other medicinal products that inhibit CYP3A may decrease the clearance of darunavir and ritonavir and may result in increased plasma concentrations of darunavir and ritonavir (e.g. indinavir azole antifungals like clotrimazole).
Maltese: L-amministrazzjoni ta' darunavir u ritonavir flimkien ma' prodotti mediċinali oħra li jimpedixxu CYP3A jistgħu jnaqqsu t-tneħħija ta' darunavir u ritonavir u jistgħu jwasslu għal konċentrazzjonijiet ogħla ta' darunavir u ritonavir fil-plażma (eż. indinavir, antifungali azoles bħal clotrimazole).
English: HIV-1 RNA < 50 copies/ml CD4+ percent change from baseline CD4+ cell count mean change from baseline ≥ 1.0 log10 decrease from baseline in plasma viral load
Maltese: HIV-1 RNA < 50 kopji/ml CD4+ bidla perċentwali mil-linja bażi CD4+ bidla medja tal-għadd taċ-ċelluli millinja bażi
English: Concomitant use of darunavir coadministered wirth low dose ritonavir and these antidepressants may increase concentrations of the antidepressant.
Maltese: L-użu ta' darunavir intensifikat u dawn l-antidepressanti jista' jżid ilkonċentrazzjonijiet tal-antidepressant.
English: Systemic corticosteroid effects including Cushing's syndrome and adrenal suppression have been reported in patients receiving ritonavir and inhaled or intranasally administered fluticasone.
Maltese: Effetti sistemiċi talkortikosterojdi inkluż is-sindrome ta' Cushing u soppressjoni adrenali ġew irrappurtati f'pazjenti li kienu qed jirċievu ritonavir u fluticasone li jinġibed man-nifs jew li jingħata minn ġol-imnieħer.
English: 600 mg film-coated tablets darunavir
Maltese: Darunavir Krka d.d. 600 mg pilloli miksijin b'rita darunavir
English: 400 mg film-coated tablets darunavir
Maltese: Darunavir Krka d.d. 400 mg pilloli miksijin b'rita darunavir
English: Metabolism and nutrition disorders common diabetes mellitus, hypertriglyceridaemia, hypercholesterolaemia, hyperlipidaemia uncommon gout, anorexia, decreased appetite, decreased weight, increased weight, hyperglycaemia, insulin resistance, decreased high density lipoprotein, increased appetite, polydipsia, increased blood lactate dehydrogenase
Maltese: gotta, anoreksja, tnaqqis fl-aptit, tnaqqis fil-piż, żieda fil-piż, ipergliċemija, reżistenza għallinsulina, tnaqqis fil-lipoproteina ta' densità għolja, żieda fl-aptit, polidipsja, żieda fil-lactate dehydrogenase fid-demm
English: The dose is either: 800 milligram Darunavir Krka d.d.
Maltese: Darunavir Krka d.d. 800 mg pilloli miksijin b'rita darunavir
English: ART-experienced with no darunavir resistance associated mutations (DRV-RAMs) and who have plasma HIV-1 RNA < 100,000 copies/ml and CD4+ cell count ≥ 100 cells x 10
Maltese: - F'pazjenti b'esperjenza ta' trattament retrovirali (ART) mingħajr DRV-RAMs* u li għandhom <100,000 kopja/ml ta' HIV-1/RNA fil-plażma u l-għadd ta' ċelluli ta' CD4+ ta' ≥ 100 ċellula x 10
English: Darunavir/ritonavir 600/100 mg twice daily + OBR N=298
Maltese: Effetti darunavir/ritonavir 600/100 mg darbtejn kuljum + OBR N=298
English: 600 mg tablets.
Maltese: 400 mg darba kuljum.
English: Other medicines and Darunavir Krka d.d.
Maltese: Mediċini oħra u Darunavir Krka d.d.
English: Number of subjects with virologic failure a and phenotype data that show resistance to PIs at endpoint c, n/N
Maltese: Numru ta' individwi, b'falliment viroloġikua u dejta ta' fenotip li juri reżistenza għall-PIs, fil-punt finalic, n/N
English: HIV-1 RNA < 50 copies/ml CD4+ percent change from baseline CD4+ cell count mean change from baseline
Maltese: HIV-1 RNA < 50 kopja/ml Għadd taċ-ċelluli CD4+ bidla medja mil-linja bażi
English: is 800 milligram (2 tablets containing 400 milligram of Darunavir Krka d.d.
Maltese: Id-doża hija jew: - 800 milligramma Darunavir Krka d.d. (2 pillolilifihom400 milligramma ta'
English: Darunavir Krkad.d.must be taken in combination witha low dose of cobicistat or ritonavir andother anti-HIV medicines.
Maltese: Xorta tista' tgħaddi l-HIV meta tkun qiegħed tieħu din il-mediċina, għalkemm ir-riskju jonqos b'terapija antiretrovirali effettiva.
English: Tell your doctor if you take:
Maltese: Data ta' ftuħ:
English: In ART-experienced patients without DRV-RAMs* and who have plasma HIV-1 RNA < 100,000 copies/ml and CD4+ cell count ≥ 100 cells x 10
Maltese: 100,000 kopja/ml ta' HIV-1 RNA u għadd ta' ċelluli CD4+ ≥ 100 ċellula x 10
English: ODIN is a Phase III, randomised, open-label trial comparing darunavir/ritonavir 800/100 mg once daily versus darunavir/ritonavir 600/100 mg twice daily in ART-experienced HIV-1 infected patients with screening genotype resistance testing showing no darunavir RAMs (i.e. V11I, V32I, L33F, I47V, I50V, I54M, I54L, T74P, L76V, I84V, L89V) and a screening HIV-1 RNA > 1,000 copies/ml.
Maltese: Numru ta' tibdiliet ġenetiċi mil-lista ta' tibdiliet ġenetiċi assoċjati ma' nuqqas ta' rispons għalldarunavir/ritonavir (V11I, V32I, L33F, I47V, I50V, I54L jew M, T74P, L76V, I84V jew L89V) drabi ta' bidla fl-EC “Pazjenti li ma użawx ENF jew li użaw ENF qabel” huma pazjenti li ma użawx ENF jew li użaw ENF iżda mhux għall-ewwel darba “Pazjenti li qatt ma użaw ENF” huma pazjenti li użaw ENF għall-ewwel darba
English: This can be seen in a blood test. high blood pressure, flushing red or dry eyes fever, swelling of lower limbs due to fluids, malaise, irritability, pain symptoms of infection, herpes simplex erectile dysfunction, enlargement of breasts sleeping problems, sleepiness, depression, anxiety, abnormal dreams, decrease in sexual drive
Maltese: Din tista' tidher f'test tad-demm. pressjoni għolja, fwawar għajnejn ħomor jew xotti deni, nefħa fir-riġlejn minħabba fluwidi, telqa mingħajr sinjal ta' mard, irritabilità, uġigħ sintomi ta' infezzjoni, herpes simplex abnormalità erettili, tkabbir tas-sider - problemi bl-irqad, xejra ta' ngħas, depressjoni, ansjetà,ħolm mhux normali, tnaqqis fil-ġibda sesswali
English: Baseline genotype or phenotype and virologic outcome Baseline genotype and darunavir FC (shift in susceptibility relative to reference) were shown to be a predictive factor of virologic outcome.
Maltese: Linja bażi ġenotipika jew fenotipika u l-effetti viroloġiċi Il-ġenotip u l-FC ta' darunavir fil-linja bażi (bidla fis-suxxettibilità fejn għandha x'taqsam mar-riferenza) intwerew li kienu fattur ta' tbassir għalleffetti viroloġiċi.
English: Apixaban, edoxaban, rivaroxaban, warfarin (to reduce clotting of the blood) as their therapeutic effect or side effects may be altered; your doctor may have to check your blood.
Maltese: - Apixaban, edoxaban, rivaroxaban, warfarin(biex id-demm ma jikkoagulax) minħabba li l-effett terapewtiku jew l-effetti sekondarji jistgħu jinbidlu; it-tabib tiegħek jista' jkun ikollu jiċċekkjalek id-demm.
English: Bottle (HDPE), child resistant temper evident PP closure with a desiccant: - 30 tablets: 1 bottle of 30 film-coated tablets, - 60 tablets: 2 bottles of 30 film-coated tablets, - 90 tablets: 3 bottles of 30 film-coated tablets, - 180 tablets: 6 bottles of 30 film-coated tablets.
Maltese: Darunavir Krka d.d. pilloli miksijin b'rita huma disponibbli fi fliexken li fihom 30 pillola miksijin b'rita (flixkun 1 ta' 30 pillola miksijin b'rita), 60 pillola miksijin b'rita (2 fliexken ta' 30 pillola miksjin b'rita), 90 pillola miksijin b'rita (3 fliexken ta' 30 pillola miksjin b'rita) u 180 pillola miksijin b'rita (6 fliexken ta' 30 pillola miksjin b'rita) f'kaxxa.
English: Carbamazepine, clonazepam(to prevent seizures or to treat certain types of nerve pain) Colchicine (to treat gout or familial Mediterranean fever) Bosentan (to treat high blood pressure in the pulmonary circulation) Buspirone, clorazepate, diazepam, estazolam, flurazepam, midazolam when used as injection, zoldipem (sedative agents)
Maltese: Rifabutin (kontra infezzjonijiet batterjali) - Sildenafil, vardenafil, tadalafil(għal anormalità erettili jew pressjonigħolja fiċ-ċirkolazzjoni tal-pulmuni) - Amitriptyline, desipramine, imipramine, nortriptyline, paroxetine, sertraline, trazodone (biex tikkura depressjoni u ansjetà) Maraviroc (għal kura ta' infezzjoni bl-HIV) Methadone (biex tikkura dipendenza fuq l-opjati) - Carbamazepine, clonazepam(biex tilqa' kontra l-aċċessjonijiet jew biex tikkura ċerti tipi ta' uġigħ fin-nervituri) Colchicine (biex tikkura l-gotta jew deni Mediterranju familjali) Bosentan (biex tikkura pressjoni għolja fiċ-ċirkolazzjoni tal-pulmuni) - Buspirone, clorazepate, diazepam, estazolam, flurazepam, midazolam meta jintuża bħala injezzjoni, zoldipem (sustanzi sedattivi) - Perphenazine,risperidone, thioridazine(biex tikkura kundizzjonijiet psikjatriċi).
English: Glecaprevir/pibrentasvir,simeprevir (to treat hepatitis C infection) Fentanyl, oxycodone, tramadol (to treat pain)
Maltese: Boceprevir (għal infezzjoni tal-epatite C) Rifapentine, rifabutin (mediċini biex jikkuraw xi infezzjonijiet bħal ma hija ttuberkulożi)
English: film-coated tablet
Maltese: analżeġiċi fil-plażma.
English: concentrations of quetiapine may lead to coma (see section 4.3).
Maltese: Żieda filkonċentrazzjonijiet ta' quetiapine jistgħu jwasslu għal koma (ara sezzjoni 4.3).
English: Artemether/lumefantrine (a combination medicineto treat malaria) Dasatinib, everolimus,irinotecan,nilotinib, vinblastine, vincristine (to treat cancer) Sildenafil, tadalafil, vardenafil (for erectile dysfunction or to treat a heart and lung disorder called pulmonary arterial hypertension)
Maltese: Dasatinib, everolimus, irinotecan, nilotinib, vinblastine, vincristine (biex tikkura l-kanċer) - Sildenafil, tadalafil, vardenafil(għall-impotenza jew biex tikkura disturb talqalb u tal-pulmun imsejjaħ pressjoni għolja fil-pulmuni tal-arterji) Glecaprevir/pibrentasvir, simeprevir (biex titratta infezzjoni tal-epatite C) - Fentanyl, oxycodone, tramadol(biex jittrattaw l-uġigħ)
English: Adverse reactions observed with darunavir/cobicistat in adult patients
Maltese: b'darunavir/cobicistat
English: 300 mg once daily atazanavir AUC ↔ atazanavir Cmin ↑ 52% atazanavir Cmax ↓ 11% darunavir AUC ↔
Maltese: 300 mg darba kuljum atazanavir AUC ↔ atazanavir Cmin ↑ 52% atazanavir Cmax ↓ 11% #darunavir AUC ↔ #darunavir Cmin ↔ #darunavir Cmax ↔
English: based on published data with darunavir/ritonavir
Maltese: ibbażat fuq dejta pubblikata b'darunavir/ritonavir
English: 400 and 800 milligram tablets are used to treat adults and children (3 years of age and above, at least 40 kilograms body weight) who are infected by HIV and who have not used antiretroviral medicines before.
Maltese: Il-pilloli ta' Darunavir Krka d.d. 400, 800 milligramma jintużaw għat-trattament ta' adulti u tfal (3 snin u aktar, tal-anqas b'piż tal-ġisem ta' 40 kilogramma) li huma infettati bl-HIV u li qatt ma kienu użaw mediċini antiretrovirali qabel.
English: Based upon the safety profile of darunavir/ritonavir, the increase in darunavir exposure in the presence of rifabutin does not warrant a dose adjustment for darunavir/ritonavir.
Maltese: Ma huwa rrakkomandat l-ebda aġġustament fid-doża għal darunavir/ritonavir.
English: 400 mg film-coated tablets Darunavir Krka d.d.
Maltese: Darunavir Krka d.d. 400 mg pilloli miksijin b'rita:
English: HIV-1 RNA < 50 copies/ml mean HIV-1 RNA log change from baseline (log10 copies/ml)
Maltese: Medja ta' bidla fil-log ta' RNA ta' HIV-1 mil-linja bażi (kopji log10/ml)
English: always together with ritonavir.
Maltese: Mhux irrakkomandat li tibdel iddoża ta' ritonavir.
English: EU/1/17/1248/001 30 film-coated tablets EU/1/17/1248/002 60 film-coated tablets EU/1/17/1248/003 90 film-coated tablets EU/1/17/1248/004 180 film-coated tablets
Maltese: EU/1/17/1248/001 60 pillola miksijin b'rita:
English: The efficacy and safety of the use of darunavir with 100 mg ritonavir and any other HIV PI (e.g. (fos)amprenavir, nelfinavir and tipranavir) has not been established in HIV patients.
Maltese: L-effikaċja u s-sigurtà tal-użu ta' darunavir flimkien ma' 100 mg ritonavir u kwalunkwe PI ta' HIV ieħor (eż. (fos)amprenavir, nelfinavir u tipranavir) ma ġewx stabbiliti f'pazjenti bl-HIV.
English: The metabolism of alfentanil is mediated via CYP3A, and may as such be inhibited by darunavir co-administered with low dose ritonavir.
Maltese: Il-metaboliżmu ta' alfentanil huwa medjat permezz ta' CYP3A, u fil-fatt jista' jiġi impedit minn darunavir mogħti flimkien ma' doża baxxa ta' ritonavir.
English: Ergot alkaloids like ergotamine, dihydroergotamine, ergometrine and methylergonovine to treat migraine headaches
Maltese: Kwalunkwe sintomi infjammtorji għandhom jiġu evalwati u għandu jinbeda trattament fejn hemm bżonn.
English: Amitriptyline, desipramine, imipramine, nortriptyline, paroxetine, sertraline, trazodone (to treat depression and anxiety)
Maltese: Amitriptyline Desipramine Imipramine Nortriptyline Trazodone
English: Number of subjects with virologic failure a and genotype data that develop mutations b at endpoint, n/N
Maltese: Numru ta' individwi, b'falliment viroloġiku a u dejta ta' ġenotip li jiżviluppa mutazzjonijiet b, fil-punt finali, n/N
English: Medicinal products that induce CYP3A activity would be expected to increase the clearance of darunavir and ritonavir, resulting in lowered plasma concentrations of these compounds and consequently that of darunavir, leading to loss of therapeutic effect and possible development of resistance (see sections 4.3 and 4.4).
Maltese: Prodotti mediċinali li jinduċu l-attività ta' CYP3A ikunu mistennija jżidu t-tneħħija ta' darunavir u ritonavir, li jwassal għal tnaqqis fil-konċentrazzjonijiet ta' dawn is-sustanzi filplażma u konsegwenza ta' dan dik ta' darunavir, li jwassal għal telf tal-effett terapewtiku u żvilupp possibbli ta' reżistenza (ara sezzjonijiet 4.3 u 4.4).
English: 120 (3x40) capsules
Maltese: 120 (3x40) kapsula
English: Co-rapporteur(s):
Maltese: Co-rapporter(s):
English: Dr Robert James Hemmings (United Kingdom)
Maltese: Dr Robert James Hemmings (Renju Unit)
English: Dr Harald Enzmann (Germany)
Maltese: Dr Harald Enzmann (Ġermanja)
English: Ref. EMEA/CHMP/734798/2009 rev. EMEA/H/A-29/1169
Maltese: EMEA/CHMP/734798/2009 rev.
English: Article 29 of Directive 2001/83/EC as amended, referral on the grounds of potential serious risk to public health
Maltese: L-Artikolu 29 tad-Direttiva 2001/83/KE kif emendata, referenza għal raġunijiet ta' riskju potenzjali serju għassaħħa pubblika
English: The review was carried out under an ‘Article 29' referral1.
Maltese: Ir-reviżjoni saret skont referenza tal-‘Artikolu 29' 1.
English: Company responses provided on: 27 August 2009, 26 October 2009 Opinion date:
Maltese: 27 ta' Awwissu 2009, 26 ta' Ottubru 2009
English: Rapporteur:
Maltese: Rapporter:
English: What is Pantoprazole Olinka?
Maltese: X'inhu Pantoprazole Olinka?
English: Questions and answers on the referral for Pantoprazole Olinka pantoprazole 20 and 40 mg tablets
Maltese: Mistoqsijiet u tweġibiet dwar ir-referenza għal Pantoprazole Olinka pilloli ta' pantoprazole 20 u 40 mg
English: The active substance in Pantoprazole Olinka, pantoprazole, is a proton pump inhibitor.
Maltese: Is-sustanza attiva f'Pantoprazle Olinka, pantoprazole, hija inibitur tal-pompa tal-protoni.
English: Pantoprozole Olinka is a generic medicine based on the reference medicine Pantecta.
Maltese: Pantoprazole Olinka huwa prodott mediċinali ġeneriku ibbażat fuq mediċina ta' referenza Pantecta.
English: The 20 mg tablets can be used for reflux disease to treat symptoms such as heartburns and acid regurgitation (acid flowing up in the mouth), for the long-term management and prevention of relapse in reflux oesophagitis (inflammation of the gullet, due to acid), for the prevention of the stomach ulcers that can be caused by some medicines used to treat pain and inflammations called non-selective non-steroidal anti-inflammatory drugs (NSAIDs), when the patient needs continuous NSAID treatment.
Maltese: Il-pilloli ta' 20 mg jistgħu jintużaw għal mard ta' rifluss biex jiġu ttrattati s-sintomi bħal ħruq talistonku u rigurġitazzjoni ta' aċidu (aċidu li jitla' 'l fuq fil-ħalq), għal ġestjoni fuq tul ta' żmien twil u lprevenzjoni ta' rikaduta ta' oesofaġite ta' rifluss (infjammazzjoni tal-gerżuma tal-ikel, minħabba aċidu), għall-prevenzjoni ta' ulċeri tal-istonku li jistgħu jiġu kkawżati minn xi mediċini użati għallkura ta' wġigħ u infjammazzjonijiet imsejħin mediċini antiinfjammatorji mhux sterojdi mhux selettivi (NSAIDs), meta l-pazjent ikun jeħtieġ kura kontinwa bl-NSAIDs.
English: The 40 mg tablets can be used for more severe acid diseases such as stomach ulcer, duodenal ulcer, Zollinger-Ellison syndrome (a condition caused by oversecretion of acid in the stomach) and to help rid the stomach of a bacterium called Helicobacter pylori, which is known to cause stomach ulcer.
Maltese: Il-pilloli ta' 40 mg jistgħu jintużaw għal mard tal-aċidu aktar serju bħal ulċera fl-istonku, ulċera duwodenali, sindromu Zollinger-Ellison (kundizzjoni kkawżata minn sekrezzjoni żejda ta' aċidu flistonku) u biex jgħinu lill-istonku jeħles minn batteru msejjaħ Heliobacter pylori, li huwa magħruf li jikkawża ulċera fl-istonku.
English: Olinka UK Ltd. submitted Pantoprazole Olinka to the United Kingdom medicines regulatory agency for a decentralised procedure.
Maltese: Olinka Uk Ltd. issottomettiet Pantoprazole Olinka lill-aġenzija regolatorja tal-mediċini fir-Renju Unit għal proċedura deċentralizzata.
English: Pantoprazole Olinka is presented as gastro-resistant tablets.
Maltese: Pantoprazole Olinka huwa ppreżentat bħala pilloli gastro-reżistenti.
English: Why was Pantoprazole Olinka reviewed?
Maltese: Għaliex ġie rivedut Pantoprazole Olinka?
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of Pantoprazole Olinka outweigh its risks, and the marketing authorisation can be granted in the United Kingdom and in the following Member States of the European Union, the Czech Republic, Germany, Poland and Slovakia.
Maltese: tqegħid fis-suq li tkun valida f'dak il-pajjiż kif ukoll fi Stati Membri oħrajn (‘l-Istati Membri kkonċernati', f'dan il-każ ir-Repubblika Ċeka, il-Ġermanja, il-Polonja u s-Slovakja).
English: By blocking the pumps, pantoprazole reduces acid production.
Maltese: Bl-imblukkar tal-pompi, pantoprazole inaqqas il-produzzjoni tal-aċidu.
English: It works by blocking ‘proton pumps', proteins found in specialised cells in the stomach lining that pump acid into the stomach.
Maltese: Taħdem billi timblokka ‘pompi tal-protoni', protejini li jinsabu f'ċelloli speċjalizzati fl-inforra tal-istonku li jippumpjaw aċidu fl-istonku.
English: The grounds for the referral were concerns expressed by the German medicines regulatory agency regarding the bioequivalence study comparing Pantoprazole Olinka and Pantecta.
Maltese: Ir-raġunijiet għar-riferiment kienu t-tħassib imfisser mill-aġenzija regolatorja tal-mediċini Ġermaniża dwar l-istudju ta' bijoekwivalenza li jqabbel Pantoprazole Olinka u Pantecta.
English: 20 hard capsules
Maltese: 20 kapsula.
English: TMZ + concomitant RT n = 288*
Maltese: TMZ + RT flimkien n = 288*
English: TMZ monotherapy n = 224
Maltese: TMZ waħdu n = 224
English: Doses of 500, 750, 1,000, and 1,250 mg/m² (total dose per cycle over 5 days) have been evaluated clinically in patients.
Maltese: Dożi ta' 500, 750, 1,000, u 1,250 mg/m² (doża totali kull ċiklu matul 5 ijiem) ġew evalwati klinikament f'pazjenti.
English: Temomedac may cause permanent infertility.
Maltese: Temomedac jista' jikkawża infertilità permanenti.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 25 January 2010
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 25 ta' Jannar 2010
English: Pancytopenia, anaemia (Grade 3 - 4), leukopenia
Maltese: Panċitopenija, anemija (Grad 3 - 4), lewkopenja
English: PHARMACEUTICAL FORM Hard capsule (capsule).
Maltese: Kapsula iebsa (kapsula).
English: Herpes simplex, herpes zoster, influenza-like symptoms
Maltese: Herpes simplex, herpes zoster,
English: Date of latest renewal: 18 July 2014
Maltese: Data tal-aħħar tiġdid: 18 ta' Lulju 2014
English: myelodysplastic syndrome (MDS), secondary malignancies, including myeloid leukaemia
Maltese: Sindrome majelodisplastiku (MDS - myelodysplastic syndrome), mard sekondarju malinn, inkluż lewkimja majelojde