FrancophonIA/ELRC3.0 huggingface dataset:
English: However, the marketing authorisation holder shall submit periodic safety update reports for this medicinal product if the product is included in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Maltese: prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u ppubblikati fuq il-portal elettroniku Ewropew tal-mediċini.
English: The hard capsules (length approx. 18 mm) have a white opaque body and cap with two stripes in orange ink on the cap and with “T 20 mg” in orange ink on the body.
Maltese: Il-kapsuli ibsin (tul ta' madwar, 18 mm) għandhom korp abjad opak u għatu b'żewġ strixxi b'linka oranġjo fuq l-għatu u b'“T 20 mg” b'linka oranġjo fuq il-korp.
English: a: Treatment with concomitant TMZ can be continued when all of the following conditions are met: absolute neutrophil count ≥ 1.5 x 109/l; thrombocyte count ≥ 100 x 109/l; CTC non-haematological toxicity ≤ Grade 1 (except for alopecia, nausea, vomiting).
Maltese: Il-kura b'TMZ mogħti b'mod konkomitanti tista' titkompla meta jintlaħqu dawn il-kondizzjonijiet kollha li ġejjin: għadd assolut tan-newtrofili ≥ 1.5 x 109/l; għadd tat-tromboċiti ≥ 100 x 109/l; tossiċità mhux ematoloġika ta' CTC ta' ≤ Grad 1 (ħlief għal alopeċja, tqalligħ, rimettar).
English: Myelosuppression was predictable (usually within the first few cycles, with the nadir between Day 21 and Day 28), and recovery was rapid, usually within 1 - 2 weeks.
Maltese: Majelosuppressjoni setgħet tkun imbassra (normalment fl-ewwel ftit ċikli, bl-aktar punt baxx ma' Jum 21 u Jum 28), u l-irkupru kien mgħaġġel, normalment fi żmien 1 - 2 ġimgħat.
English: Adverse reactions in patients with recurrent or progressive malignant glioma Infections and infestations
Maltese: Reazzjonijiet avversi f'pazjenti bi glijoma malinna rikurrenti jew progressiva Disturbi fil-metaboliżmu u n-nutrizzjoni
English: Temomedac 20 mg two stripes in orange ink on the cap and “T 20 mg” in orange ink on the body
Maltese: Temomedac 20 mg żewġ strixxi b'linka oranġjo fuq l-għatu u “T 20 mg” b'linka oranġjo fuq il-korp
English: Table 4 provides treatment-emergent adverse events in patients with newly-diagnosed glioblastoma multiforme during the concomitant and monotherapy phases of treatment.
Maltese: Tabella 4 turi r-reazzjonijiet avversi li tfaċċaw mal-kura f'pazjenti li jkunu għadhom kif ġew iddijanjostikati bi glioblastoma multiforme waqt il-fażijiet ta' terapija konkomitanti u monoterapija.
English: A complete blood count should be obtained on Day 22 (21 days after the first dose) or within 48 hours of that day, and weekly until ANC > 1.5 x 109/l and platelet count > 100 x 109 /l.
Maltese: Għadd komplet tad-demm għandu jinkiseb fit-22 jum (21 jum wara l-ewwel doża) jew sa 48 siegħa minn dak il-jum, u kull ġimgħa sakemm l-ANC ikun > 1.5 x 109/l u l-għadd talplejtlets ikun > 100 x 109/l.
English: Capsule shell gelatin, titanium dioxide (E171)
Maltese: Titanium dioxide (E 171)
English: EU/1/09/605/012
Maltese: EU/1/09/605/011 EU/1/09/605/012
English: Uncommon (may affect up to 1 in 100 people): reduced blood cell counts (pancytopenia, anaemia, leukopenia).
Maltese: Mhux komuni (jistgħu jaffettwaw sa persuna waħda minn kull 100): tnaqqis fl-għadd taċ-ċelluli tad-demm (panċitopenija, anemija, lewkopenija).
English: NAME OF THE MEDICINAL PRODUCT Temomedac 100 mg hard capsules temozolomide
Maltese: Temomedac 100 mg kapsuli ibsin temozolomide
English: TMZ is to be discontinued if: dose level -1 (100 mg/m²) still results in unacceptable toxicity the same Grade 3 non-haematological toxicity (except for alopecia, nausea, vomiting) recurs after dose reduction.
Maltese: Livell tad-doża -1 (100 mg/m²) jibqa jirriżulta f'tossiċità inaċċettabbli L-istess tossiċità mhux ematoloġika ta' Grad 3 (ħlief għal alopeċja, tqalligħ, rimettar) terġa tiġri wara tnaqqis fiddoża
English: Patients in the TMZ + RT arm received concomitant TMZ (75 mg/m²) once daily, starting the first day of RT until the last day of RT, for 42 days (with a maximum of 49 days).
Maltese: Il-pazjenti fil-fergħa ta' TMZ + RT irċevew flimkien TMZ (75 mg/m²) darba kuljum, bdew fl-ewwel jum ta' RT sa l-aħħar jum ta' RT għal 42 jum (sa mhux aktar minn 49 jum).
English: Single-cycle (5-day dosing, 23 days non-treatment), 3- and 6-cycle toxicity studies were conducted in rats and dogs.
Maltese: Studi dwar l-effett tossiku minn ċiklu wieħed (dożaġġ ta' 5 ijiem, 23 jum mingħajr trattament), 3- u 6 ċikli kienu magħmula fuq firien u klieb.
English: Convulsions were reported very commonly in the newly-diagnosed glioblastoma multiforme patients receiving monotherapy, and rash was reported very commonly in newly-diagnosed glioblastoma multiforme patients receiving TMZ concurrent with RT and also as monotherapy, and commonly in recurrent glioma.
Maltese: Pazjenti adulti bi glioblastoma multiforme li tkun għadha kif ġiet iddijanjostikata Kura biex tilqa' għat-tqalligħ hija rakkomandata qabel l-ewwel doża tal-fażi konkomitanti u hija rakkomandata ħafna waqt il-fazi b'monoterapija.
English: Oral TMZ has been studied in paediatric patients (age 3 - 18 years) with recurrent brainstem glioma or recurrent high grade astrocytoma, in a regimen administered daily for 5 days every 28 days.
Maltese: TMZ orali kien studjat f'pazjenti pedjatriċi (età ta' 3 snin - 18-il sena) bi glijoma rikorrenti taz-zokk ċentrali tal-moħħ jew b'astroċitoma rikorrenti ta' grad għoli, f'kors mogħti kuljum għal 5 ijiem kull 28 jum.
English: In patients treated with TMZ, whether used in combination with RT or as monotherapy following RT for newly-diagnosed glioblastoma multiforme, or as monotherapy in patients with recurrent or progressive glioma, the reported very common adverse reactions were similar: nausea, vomiting, constipation, anorexia, headache and fatigue.
Maltese: F'pazjenti kkurati b'TMZ, kemm kombinat ma' RT, kif ukoll bħala monoterapija wara RT għal glijoblastoma multiforme li tkun għadha kif ġiet iddijanjostikata, jew bħala monoterapija f'pazjenti bi glijoma rikorrenti jew progressiva, ir-reazzjonijiet avversi komuni ħafna rappurtati kienu simili: tqalligħ, rimettar, stitikezza, anoressija, uġigħ ta' ras u għejja.
English: Temomedac 20 mg hard capsules shellac propylene glycol, titanium dioxide (E171) sunset yellow FCF (E110) aluminium lake
Maltese: Temomedac 20 mg kapsuli ibsin: gelatin, titanium dioxide (E 171), shellac, propylene glycol, Sunset yellow FCF Aluminium Lake (E 110).
English: CTC non-haematological toxicity (except for alopecia, nausea, vomiting) CTC Grade 3
Maltese: Tossiċità mhux ematoloġika ta' CTC (ħlief għal alopeċja, tqalligħ, rimettar)
English: Adult patients with newly-diagnosed glioblastoma multiforme
Maltese: Pazjenti adulti li jkunu għadhom kif ġew iddijanjostikati bi glijoblastoma multiforme
English: Temomedac in combination treatment with radiotherapy in newly-diagnosed glioblastoma
Maltese: Disturbi muskolu-skeletriċi u tat-tessuti konnettivi
English: Hemiparesis, aphasia, balance impaired, somnolence, confusion, dizziness, memory impairment, concentration impaired, dysphasia, neurological disorder (NOS), neuropathy, peripheral neuropathy, paraesthesia, speech disorder, tremor
Maltese: sturdament, indeboliment tal memorja, indeboliment talkonċentrazzjoni, disfażja, disturbi newroloġiċi (NOS), newropatija, newropatija periferali, parasteżija, ma jitkellmux tajjeb, tregħid
English: Temomedac 5 mg hard capsules: gelatin, titanium dioxide (E 171), shellac, propylene glycol, indigo carmine (E 132) aluminium lake, yellow iron oxide (E 172) Temomedac 20 mg hard capsules: gelatine, titanium dioxide (E 171), shellac, propylene glycol, sunset yellow FCF aluminium Lake (E 110).
Maltese: Temomedac 5 mg kapsuli ibsin: gelatin, titanium dioxide (E 171), shellac, propylene glycol, Indigo carmine (E 132) aluminium lake, yellow ironoxide (E 172).
English: Temomedac is administered in combination with focal radiotherapy (concomitant phase) followed by up to 6 cycles of temozolomide (TMZ) monotherapy (monotherapy phase).
Maltese: Temomedac jingħata flimkien ma' radjuterapija fokali (fażi konkomitanti) segwit b'mhux aktar minn 6 ċikli ta' b'monoterapija ta' temozolomide (TMZ) (fażi ta' monoterapija).
English: A treatment cycle with Temomedac lasts 28 days.
Maltese: Ċiklu ta' kura b'Temomedac jinkludi 28 jum.
English: The following additional serious adverse reactions have been identified during post-marketing exposure:
Maltese: Ir-reazzjonijiet avversi serji addizzjonali li ġejjin ġew identifikati waqt esponiment wara t-tqegħid fissuq: Tabella 6.
English: prolonged pancytopenia, aplastic anaemia Neoplasm benign, malignant and unspecified Very rare:
Maltese: Ġilda titqaxxar, reazzjoni ta' sensitività għad-dawl, lewn tal-ġilda anormali
English: Anti-emetic therapy
Maltese: Terapija kontra t-tqalligħ
English: Temomedac 5 mg two stripes in green ink on the cap and “T 5 mg” in green ink on the body
Maltese: Temomedac 5 mg żewġ strixxi b'linka ħadra fuq l-għatu u “T 5 mg” b'linka ħadra fuq il-korp
English: Hepatic enzymes increased, Gamma
Maltese: Żieda ta' l-enzimi epatiċi, żieda ta' gamma GT, żieda ta' AST
English: Dyspnoea, coughing
Maltese: (NOS), gastroenterite, emorrojdi
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Temomedac 250 mg hard capsules temozolomide
Maltese: Red iron oxide (E 172) Temomedac 250 mg kapsuli ibsin
English: *A patient who was randomised to the RT arm only, received TMZ + RT.
Maltese: *Pazjent li kien randomised għal fergħa ta' RT biss, ingħata TMZ + RT.
English: EU/1/09/605/008
Maltese: EU/1/09/605/007 EU/1/09/605/008
English: Patients with tumours that have returned or worsened (malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma) taking Temomedac only
Maltese: Pazjenti b'tumuri li reġgħu ħarġu jew aggravaw (glijoma malinna, bħal glijoblastoma multiforme jew astroċitoma anaplastika) li qed jieħdu Temomedac biss
English: Somnolence, dizziness, paraesthesia
Maltese: Dijarea, uġigħ addominali, dispepsja
English: Temomedac 100 mg two stripes in pink ink on the cap and “T 100 mg” in pink ink on the body
Maltese: Temomedac 100 mg żewġ strixxi b'linka roża fuq l-għatu u “T 100 mg” b'linka roża fuq il-korp
English: Temomedac 20 mg hard capsules have a white opaque body and cap with two stripes in orange ink on the cap and with “T 20 mg” in orange ink on the body.
Maltese: Temomedac 20 mg kapsuli ibsin għandhom korp abjad opak u għatu b'żewġ strixxi b'linka oranġjo fuq l-għatu u b'“T 20 mg” b'linka oranġjo fuq il-korp.
English: Temomedac 250 mg two stripes in black ink on the cap and “T 250 mg” in black ink on the body
Maltese: Temomedac 250 mg żewġ strixxi b'linka sewda fuq l-għatu u “T 250 mg” b'linka sewda fuq il-korp
English: EU/1/09/605/002
Maltese: EU/1/09/605/001 EU/1/09/605/002
English: Elderly patients appear to be at increased risk of neutropenia and thrombocytopenia, compared with younger patients.
Maltese: Pazjenti anzjani jidhru li huma f'riskju akbar li jkollhom newtropenija u tromboċitopenja, meta mqabbla ma' pazjenti iżgħar.
English: - absolute neutrophil count (ANC) ≥ 1.5 x 109/l - thrombocyte count ≥ 100 x 109/l - common toxicity criteria (CTC) non-haematological toxicity ≤ Grade 1 (except for alopecia,
Maltese: • tossiċità mhux ematoloġika ta' kriterju komuni tat-tossiċità (CTC) ta' ≤ Grad 1 (ħlief għal alopeċja, tqalligħ u rimettar).
English: EU/1/09/605/006
Maltese: EU/1/09/605/005 EU/1/09/605/006
English: In preclinical studies in rats and rabbits receiving 150 mg/m² TMZ, teratogenicity and/or foetal toxicity were demonstrated (see section 5.3).
Maltese: Fi studji ta' qabel l-użu kliniku fuq firien u fniek li kienu qed jirċievu 150 mg/m² TMZ, kienu murija -teratoġeniċità u/jew effett tossiku fuq il-fetu (ara sezzjoni 5.3). Temomedac m'għandux jingħata lil nisa waqt it-tqala.
English: Amber glass bottle with white polypropylene child-resistant closure equipped with an induction seal of polyethylene containing 5 or 20 capsules.
Maltese: Flixkun tal-ħġieġ ta' lewn kannella b'tapp abjad tal-polypropylene reżistenti għat-tfal, mgħammar b'siġill ta' induzzjoni tal-polyethylene li fih 5 jew 20 kapsula.
English: Very common (may affect more than 1 in 10 people): reduced number of blood cells (neutropenia or lymphopenia, thrombocytopenia), loss of appetite, headache, vomiting, nausea (feeling sick in your stomach), constipation (difficulty passing stools), tiredness.
Maltese: Komuni ħafna (jistgħu jaffettwaw aktar minn persuna waħda minn kull 10): tnaqqis fl-għadd taċċelluli tad-demm (newtropenija jew limfopenija, tromboċitopenija), telf ta' aptit, uġigħ ta' ras, rimettar, dardir (tħoss l-istonku mhux floku), stitikezza (tbati biex tipporga), għeja.
English: PC:
Maltese: CTC
English: Further information on Binocrit 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: Binocrit received a marketing authorisation valid throughout the EU on 28 August 2007.
Maltese: Binocrit irċieva awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fit-28 ta' Awwissu 2007.
English: For patients with kidney failure, myelodysplastic syndromes or receiving chemotherapy, haemoglobin levels should remain within the recommended range (between 10 and 12 grams per decilitre in adults and between 9.5 and 11 g/dl in children).
Maltese: Għal pazjenti b'insuffiċjenza tal-kliewi, b'sindromi majelodisplastiċi jew li jkunu qed jirċievu kimoterapija, il-livelli tal-emoglobina għandhom jibqgħu fil-medda rakkomandata (bejn 10 grammi u 12-il gramma għal kull deċilitru fl-adulti u bejn 9.5 u 11 g/dl fit-tfal).
English: Binocrit contains the active substance epoetin alfa and is a ‘biosimilar medicine'.
Maltese: Binocrit fih is-sustanza attiva epoetin alfa u huwa “mediċina bijosimili”.
English: Binocrit, injected into a vein, was compared with the reference medicine in one main study involving 479 patients with anaemia caused by kidney problems.
Maltese: Binocrit, injettat ġo vina, tqabbel mal-mediċina ta' referenza fi studju ewlieni wieħed li fih ħadu sehem 479 pazjent b'anemija kkawżata minn problemi fil-kliewi.
English: The reference medicine for Binocrit is Eprex/Erypo.
Maltese: Ilmediċina ta' referenza għal Binocrit hija Eprex/Erypo.
English: Other information about Binocrit
Maltese: Informazzjoni oħra dwar Bincorit
English: What are the risks associated with Binocrit?
Maltese: X'inhuma r-riskji assoċjati ma' Binocrit?
English: Laboratory studies comparing Binocrit with the reference medicine Eprex/Erypo have shown that the active substance in Binocrit is highly similar to that in Eprex/Erypo in terms of structure, purity and biological activity.
Maltese: Studji fil-laboratorji li qabblu Binocrit mal-mediċina ta' referenza Eprex/Erypo wrew li s-sustanza attiva f'Binocrit hija simili ħafna għal dik f'Eprex/Erypo f'termini ta' struttura, purità u attività bijoloġika.
English: • to treat anaemia (low red blood cell counts) that is causing symptoms in patients with ‘chronic kidney failure' (long-term, progressive decrease in the ability of the kidneys to work properly) or other kidney problems;
Maltese: • għall-kura tal-anemija (għadd baxx ta' ċelluli tad-demm ħomor) li tkun qed tikkawża sintomi f'pazjenti b'‘insuffiċjenza kronika tal-kliewi' (tnaqqis progressiv u fit-tul fil-kapaċità tal-kliewi li jaħdmu sew) jew bi problemi oħra fil-kliewi;
English: As for all medicines, data on the use of Binocrit are continuously monitored.
Maltese: Bħal għall-mediċini kollha, id-data dwar l-użu ta' Binocrit hija ssorveljata kontinwament.
English: The most common side effects with Binocrit (which may affect more than 1 in 10 people) are nausea (feeling sick),diarrhoea, vomiting, fever and headache.
Maltese: L-effetti sekondarji l-aktar komuni b'Binocrit (li jistgħu jaffettwaw aktar minn persuna 1 minn kull 10) huma nawsja (tħossok ma tiflaħx), dijarea, rimettar, deni u wġigħ ta' ras.
English: • patients about to undergo major orthopaedic surgery who have severe cardiovascular (heart and blood vessel) problems including a recent heart attack or stroke.
Maltese: • pazjenti li se jsirilhom intervent kirurġiku ortopediku maġġuri li għandhom problemi kardjovaskulari serji (fil-qalb u fil-vażi) inkluż attakk tal-qalb reċenti jew puplesija.
English: The active substance in Binocrit, epoetin alfa, is a copy of a hormone called erythropoietin, and works in exactly the same way as the natural hormone to stimulate the production of red blood cells in the bone marrow.
Maltese: Is-sustanza attiva f'Binocrit, l-epoetin alfa, hija kopja ta' ormon imsejjaħ eritropojetina, u taħdem eżattament bl-istess mod bħall-ormon naturali biex tistimula l-produzzjoni taċ-ċelluli tad-demm ħomor fil-mudullun.
English: • to treat anaemia in adults with myelodysplastic syndromes (conditions in which the production of healthy blood cells is defective).
Maltese: • għall-kura tal-anemija f'adulti b'sindromi majelodisplastiċi (kundizzjonijiet li fihom il-produzzjoni ta' ċelluli tad-demm b'saħħithom hija difettuża).
English: This means that Binocrit is highly similar to another biological medicine (the ‘reference medicine') that is already authorised in the EU.
Maltese: Dan ifisser li Binocrit huwa simili ħafna għal mediċina bijoloġika oħra (il-‘mediċina ta' referenza') li diġà hija awtorizzata fl-UE.
English: The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Binocrit has a highly similar structure, purity and biological activity to Eprex/Erypo and is distributed in the body in the same way.
Maltese: L-Aġenzija Ewropea għall-Mediċini ddeċidiet li, b'mod konformi mar-rekwiżiti tal-UE għal mediċini bijosimili, Binocrit wera li għandu struttura, purità u attività bijoloġika simili ħafna għal Eprex/Erypo u jiġi distribwit bl-istess mod fil-ġisem.
English: Binocrit is used when patients are at low or intermediate risk of developing acute myeloid leukaemia and have low levels of the natural hormone erythropoietin.
Maltese: Binocrit jintuża meta l-pazjenti huma f'riskju baxx jew intermedju li jiżviluppaw lewkimja majelojde akuta u għandhom livelli baxxi tal-ormon naturali eritropojetina.
English: What measures are being taken to ensure the safe and effective use of Binocrit?
Maltese: X'miżuri qegħdin jittieħdu biex jiġi żgurat l-użu sigur u effettiv ta' Binocrit?
English: Another study showed that Binocrit injected under the skin was as effective in maintaining haemoglobin levels as Eprex/Erypo in 114 cancer patients who were receiving chemotherapy.
Maltese: Studju ieħor fuq 114-il pazjent bil-kanċer li kienu qed jirċievu kimoterapija wera li Binocrit injettat taħt il-ġilda kien effettiv daqs Eprex/Erypo biex iżomm il-livelli ta' emoglobina f'livelli rakkomandati.
English: Binocrit is a medicine used for the following:
Maltese: Aktar informazzjoni dwar Binocrit tinstab fis-sit elettroniku tal-Aġenzija:
English: For the full list of side effects of Binocrit, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji ta' Binocrit, ara l-fuljett ta' tagħrif.
English: Side effects reported with Binocrit are carefully evaluated and any necessary action taken to protect patients.
Maltese: L-effetti sekondarji rrappurtati b'Binocrit huma evalwati bir-reqqa u kull azzjoni meħtieġa hi meħuda biex tipproteġi lill-pazjenti.
English: Because Binocrit is a biosimilar medicine, the studies on effectiveness and safety of epoetin alfa carried out with Eprex/Erypo do not all need to be repeated for Binocrit.
Maltese: Peress li Binocrit huwa mediċina bijosimili, l-istudji dwar l-effikaċja u s-sigurtà tal-epoetin alfa li saru b'Eprex/Erypo m'għandhomx bżonn jiġu ripetuti kollha għal Binocrit.
English: Therefore the Agency's view was that, as for Eprex/Erypo, the benefit of Binocrit outweighs the identified risk and it can be authorised.
Maltese: Għaldaqstant, il-fehma tal-Aġenzija kienet li, bħal fil-każ ta' Eprex/Erypo, il-benefiċċju ta' Binocrit huwa akbar mir-riskju identifikat u li jista' jiġi awtorizzat.
English: Studies have also shown that giving Binocrit produces similar levels of the active substance in the body to giving Eprex/Erypo.
Maltese: Listudji wrew ukoll li l-għoti ta' Binocrit jipproduċi livelli simili tas-sustanza attiva fil-ġisem bħall-għoti ta' Eprex/Erypo.
English: ARROW PK Substudy Part 1
Maltese: Sottostudju PK ARROW Parti 1
English: PENTA 13 2 to 12 years (N=19) PENTA 15 3 to 36 months (N=17)
Maltese: PENTA 13 2 sa 12-il sena (N=19) PENTA 15 3 sa 36 xahar (N=17)
English: 3 to 12 years (N=35)
Maltese: 3 sa 12-il sena (N=35)
English: Aspen Bad Oldesloe GmbH Industriestrasse 32-36 23843 Bad Oldesloe Germany
Maltese: Aspen Bad Oldesloe GmbH Industriestrasse 32-36
English: Epivir contains methyl parahydroxybenzoate and propyl parahydroxybenzoate.
Maltese: Epivir fih methyl parahydroxybenzoate u propyl parahydroxybenzoate.
English: Epivir contains sucrose.
Maltese: Epivir fih sucrose.
English: Each 15 ml dose contains 3 g sucrose (20% w/v).
Maltese: Kull doża ta' 15 ml fiha 3 g ta' sucrose (20% w/v).
English: Glaxo Operations UK Limited (trading as Glaxo Wellcome Operations) Priory Street, Ware
Maltese: Glaxo Operations UK Limited (fil-kummerċ Glaxo Wellcome Operations) Priory Street, Ware
English: Hypromellose (E464), Titanium dioxide (E171), Black iron oxide (E172),
Maltese: Hypromellose (E464), Titanium dioxide (E171), Black iron oxide (E172), Macrogol, Polysorbate 80
English: Coadministration of sorbitol solution (3.2 g, 10.2 g, 13.4 g) with a single 300 mg dose of lamivudine oral solution resulted in dose-dependent decreases of 14%, 32%, and 36% in lamivudine exposure (AUC) and 28%, 52%, and 55% in the Cmax of lamivudine in adults.
Maltese: L-għoti flimkien tas-soluzzjoni ta' sorbitol (3.2 g, 10.2 g, 13.4 g) ma' doża waħda ta' 300 mg ta' soluzzjoni orali ta' lamivudine rriżulta fi tnaqqis dipendenti fuq id-doża ta' 14%, 32%, u 36% f'esponiment għal lamivudine (AUC) u 28%, 52%, u 55% fis-Cmax ta' lamivudine fl-adulti.
English: Once Daily N (%)
Maltese: Darba Kuljum N (%)
English: • medicines (usually liquids) containing sorbitol and other sugar alcohols (such as xylitol,
Maltese: • mediċini (normalment likwidi) li fihom sorbitol u alkoħol ieħor taz-zokkor (bħal xylitol,
English: Glaxo Operations UK Ltd (trading as GlaxoWellcome Operations), Harmire Road, Barnard Castle, Co. Durham DL12 8DT, United Kingdom
Maltese: Glaxo Operations UK Ltd (trading as GlaxoWellcome Operations), Harmire Road, Barnard Castle, Co.
English: Each 300 mg tablet contains 0.756 mg sodium.
Maltese: Kull pillola ta' 300 mg fiha 0.756 mg ta' sodju.
English: Each 15 ml dose contains 44.1 mg sodium.
Maltese: Kull doża ta' 15 ml fiha 44.1 mg ta' sodju.
English: Pharmacotherapeutic group: nucleoside analogue, ATC Code: J05AF05.
Maltese: Kategorija farmakoterapewtika: analogu ta' nukleoside, Kodiċi ATC:
English: PVC/aluminium foil blister packs:
Maltese: Pakketti b'folji ta' PVC/aluminju:
English: At a therapeutic dose of 300 mg once daily, the mean (CV) steady-state Cmax, Cmin and 24h AUC are 2.0 µg/ml (26%), 0.04 µg/ml (34%) and 8.9 µg.h/ml (21%), respectively.
Maltese: B'doża terapewtika ta' 300 mg kuljum, Cmax medju, Cmin medju fi stat stabbli u 24h AUC f'24 siegħa huma 2.0 µg/ml (26%), 0.04 µg/ml (34%) u 8.9 µg.h/ml (21%), rispettivament.
English: No antagonistic effects in vitro were seen with lamivudine and other anti retrovirals (tested agents: abacavir, didanosine, nevirapine and zidovudine).
Maltese: Ma deher ebda effett antiagonistiku in vitro b'lamivudine u b'antiretrovirali oħrajn (aġenti ttestjati: abacavir, didanosine, nevirapine u zidovudine).
English: Frequencies are defined as very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000).
Maltese: Il-frekwenzi huma definiti bħala komuni ħafna (≥1/10), komuni (≥1/100 sa ≥1/10 ), mhux komuni (≥1/1,000 sa <1/100), rari (≥1/10,000 sa <1/1,000), rari ħafna (<1/10,000).
English: Epivir is a type of medicine known as an anti-retroviral.
Maltese: Epivir huwa tip ta' mediċina magħrufa bħala antiretrovirali.
English: Each 150 mg tablet contains 0.378 mg sodium.
Maltese: Kull pillola ta' 150 mg fiha 0.378 mg ta' sodju.