FrancophonIA/ELRC3.0 huggingface dataset:
English: Paediatric population The pharmacokinetics of azilsartan have not been studied in children under 18 years of age.
Maltese: Il-farmakokinetiċi ta' azilsartan ma ġewx studjati fit-tfal ta' età ta' taħt it-18-il sena.
English: EU/1/11/734/001 14 tablets EU/1/11/734/002 28 tablets EU/1/11/734/012 30 tablets EU/1/11/734/003 56 tablets EU/1/11/734/013 90 tablets EU/1/11/734/004 98 tablets EU/1/11/734/019 14 tablets EU/1/11/734/020 28 tablets EU/1/11/734/021 56 tablets EU/1/11/734/022 98 tablets
Maltese: EU/1/11/734/001 14-il pillola EU/1/11/734/002 28 pillola EU/1/11/734/012 30 pillola EU/1/11/734/003 56 pillola EU/1/11/734/013 90 pillola EU/1/11/734/004 98 pillola EU/1/11/734/019 14-il pillola EU/1/11/734/020 28 pillola EU/1/11/734/021 56 pillola EU/1/11/734/022 98 pillola
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
Maltese: Karatteristiċi fi gruppi speċifiċi ta' pazjenti
English: Your doctor may need to change your dose and/or to take other precautions if you are taking an ACE-inhibitor or aliskiren (see also information under the headings “Do not take Edarbi” and “Warnings and precautions”).
Maltese: Jekk qed tieħu inibitur ta' ACE jew aliskiren (ara wkoll l-informazzjoni taħt l-intestaturi “Tiħux Edarbi” u “Twissijiet u prekawzjonijiet”)
English: Aluminum blisters
Maltese: Folji tal-aluminju
English: Exposure to angiotensin II receptor antagonist therapy during the second and third trimesters is known to induce human fetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia) (see section 5.3).
Maltese: Espożizzjoni għall-kura b'antagonisti tar-riċetturi ta' angiotensin II matul it-tieni u t-tielet trimestri hu magħruf li jinduċi fetotossiċità (tnaqqis fil-funzjoni renali, oligoidramnios, ittardjar fl-ossifikazzjoni tal-kranju) u tossiċità fit-trabi tat-twelid (insuffiċjenza renali, pressjoni baxxa, iperkalemija).
English: Common side effects (may affect up to 1 in 10 people): - Dizziness - Diarrhoea - Increased blood creatine phosphokinase (an indicator of muscle damage).
Maltese: - Sturdament - Dijarea - Żieda fil-krejatinina fosfokinażi fid-demm (indikatur ta' ħsara fil-muskolu).
English: including diuretics (such as chlortalidone and hydrochlorothiazide) and calcium channel blockers (see sections 4.3, 4.4, 4.5 and 5.1).
Maltese: Jekk il-pressjoni tad-demm ma tkunx ikkontrollata b'mod adegwat b'Edarbi biss, tnaqqis miżjud filpressjoni tad-demm jista' jintlaħaq meta dan it-trattament jingħata flimkien ma' prodotti oħra mediċinali anti-ipertensivi, inklużi dijuretiċi (bħal klortalidon u idroklorotijazide) u imblokkaturi talkanali tal-kalċju (ara sezzjonijiet 4.3, 4.4, 4.5 u 5.1).
English: EXP
Maltese: Sess
English: This generally has been true for other angiotensin II receptor (AT1) antagonists and angiotensin-converting enzyme inhibitors.
Maltese: Dan ġeneralment kien jgħodd għal antagonisti ta' riċetturi ta' anġjotensina II oħra (A T1), u inibituri talenżimi li jikkonvertu l-anġjotensina.
English: - The active substance is azilsartan medoxomil (as potassium).
Maltese: X'fih Edarbi - Is-sustanza attiva hija azilsartan medoxomil (bħala potassju).
English: When Edarbi is taken with chlortalidone (a water tablet), higher levels of certain chemicals in the blood (such as creatinine), which are indicators of kidney function, have been seen commonly (in less than 1 in 10 users), and low blood pressure is also common.
Maltese: Meta Edarbi jittieħed ma' chlortalidone (pillola tal-ilma), livelli ogħla ta' ċerti kimiċi fid-demm (bħal krejatinina), li huma indikaturi tal-funzjoni tal-kliewi, kienu dehru b'mod komuni (f'inqas minn 1 minn kull 10 utenti), u pressjoni baxxa tad-demm hija wkoll komuni.
English: Tel: +48 22 608 13 00
Maltese: Takeda Polska Sp. z o.o. Tel: +48 22 608 13 00
English: Essential hypertension
Maltese: GĦAMLA KWALITATTIVA
English: Potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium and other substances that may increase potassium levels
Maltese: Dijuretiċi li jġemmgħu l-potassju, supplimenti tal-potassju, sostituti tal-melħ li fihom il-potassju u sustanzi li jistgħu iżidu l-livelli tal-potassju.
English: No increase (+5%) was observed in end-stage renal disease patients who were dialysed.
Maltese: Ebda żieda (+5%) ma kienet osservata f'pazjenti fl-aħħar stadju ta' mard renali li kienu dijalizati.
English: Dose dependent adverse events including dizziness, hypotension and serum creatinine elevations were more frequent with diuretic coadministration compared with Edarbi alone, while hypokalemia was less frequent compared with diuretic alone.
Maltese: Effetti avversi dipendenti fuq id-doża inklużi sturdament, pressjoni baxxa u elevazzjonijiet fis-serum tal-krejatinina kienu aktar frekwenti bl-għoti flimkien bl amministrazzjoni dijuretiku meta mqabbla ma' Edarbi waħdu, filwaqt li ipokalimja kienet inqasfrekwenti meta mqabbla ma' dijuretiku waħdu.
English: Reversible increases in serum lithium concentrations and toxicity have been reported during concurrent use of lithium and angiotensin-converting enzyme inhibitors.
Maltese: Żidiet riversibbli fil-konċentrazzjonijiet ta' litju fis-serum u tossiċità ġew irrapportati waqt l-użu konkorrenti ta' litju u inibituri ta' enżimi li jikkonvertu l-anġjotensina.
English: Steady-state levels of azilsartan are achieved within 5 days and no accumulation in plasma occurs with repeated once-daily dosing.
Maltese: Livelli f'stati fissi ta' azilsartan jintlaħqu fi żmien 5 ijiem u l-ebda akkumulazzjoni fil-plażma sseħħ ma' dożaġġ ta' darba repetut kuljum.
English: However, there is no clinical experience in patients with severe renal impairment or end stage renal disease (see section 4.2).
Maltese: Madankollu, m'hemmx esperjenza klinika f'pazjenti b'indeboliment renali serju jew fl-aħħar stadju ta' mard tal-kliewi (ara sezzjoni 4.2).
English: (haemoglobin).
Maltese: Emoglobina u ematokrit
English: There are no data from the use of azilsartan medoxomil in pregnant women.
Maltese: Aħżen fil-pakkett oriġinali sabiex tilqa' mid-dawl u l-umdità.
English: A thorough QT/QTc study was conducted to assess the potential of azilsartan medoxomil to prolong the QT/QTc interval in healthy subjects.
Maltese: Aħżen fil-pakkett oriġinali sabiex tilqa' mid-dawl u mill-umdità.
English: Edarbi has not been studied in patients with severe hepatic impairment and therefore its use is not recommended in this patient group (see sections 4.4 and 5.2).
Maltese: Edarbi ma ġiex studjat f'pazjenti b'indeboliment epatiku serju u għalhekk l-użu tiegħu mhux rakkomandat f'dan il-grupp ta' pazjenti (ara sezzjonijiet 4.4 u 5.2).
English: The major metabolite in plasma is formed by Odealkylation, referred to as metabolite M-II, and the minor metabolite is formed by decarboxylation, referred to as metabolite M-I.
Maltese: Il-metabolit prinċipali fil-plażma huwa ffurmat mill-O-dealkylation, riferut bħala metabolit M-II, u l-iżgħar metabolit huwa ffurmat minn dekarbossazzjoni, riferut bħala metabolit M-I. Espożizzjonijiet sistemiċi lejn il-metaboliti prinċipali u minuri fil-bnedmin kienu madwar 50% u inqas minn 1% ta' azilsartan, rispettivament.
English: No overall differences in safety and effectiveness were observed between elderly patients and younger patients, but greater sensitivity to blood pressure lowering effects in some elderly individuals cannot be ruled out (see section 4.2).
Maltese: L-ebda differenzi globali fis-sigurtà u l-effikaċja bejn pazjenti anzjani u pazjenti iżgħar, iżda sensittivita' ogħla għall- effetti li jbaxxu l-pressjoni fid-demm f'xi individwi anzjani ma jistax jiġi eskluż (ara sezzjoni 4.2).
English: Further information on Nimenrix can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/nimenrix.
Maltese: ema.europa.eu/medicines/human/EPAR/nimenrix.
English: Nimenrix (meningococcal group A, C, W-135 and Y conjugate vaccine)
Maltese: Nimenrix (grupp meningokokkali A, C, W-135 u Y vaċċin ikkonjugat)
English: Other information about Nimenrix
Maltese: Informazzjoni oħra dwar Nimenrix
English: Nimenrix was compared with several other similar vaccines against N. meningitidis.
Maltese: Nimenrix tqabbel ma' diversi vaċċini simili oħra kontra N. meningitidis.
English: Nimenrix received a marketing authorisation valid throughout the EU on 20 April 2012.
Maltese: Nimenrix ingħata awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fl-20 ta' April 2012.
English: Nimenrix is a vaccine used to protect adults, adolescents and children from the age of 6 weeks against invasive meningococcal disease caused by four groups of the bacterium Neisseria meningitidis (group A, C, W-135, and Y).
Maltese: Nimenrix huwa vaċċin li jintuża biex jipproteġi l-adulti, l-adoloxxenti u lit-tfal minn 6 ġimgħat ‘il fuq kontra mard meningokokkali invażiv ikkaġunat minn erba' gruppi tal-batterju Neisseria meningitidis (grupp A, C, W-135, u Y).
English: The most common side effects from initial vaccination with Nimenrix (which may affect more than 1 patient in 10) are loss of appetite, irritability, drowsiness, headache, fever, swelling, pain and redness at the site of injection, and tiredness.
Maltese: L-effetti sekondarji l-aktar komuni mit-tilqim inizjali b'Nimenrix (li jistgħu jaffettwaw aktar minn pazjent wieħed minn kull 10) huma nuqqas ta' aptit, irritabbiltà, ħedla, uġigħ ta' ras, deni, nefħa, uġigħ u ħmura fis-sit tal-injezzjoni, u għeja.
English: Based on data from this study and additional data from a supporting study in 187 infants, this dose of Nimenrix was also considered to be effective in children between 12 weeks and less than 6 months of age.
Maltese: Abbażi ta' data minn dan l-istudju u data addizzjonali minn studju ta' appoġġ f'187 tarbija, din id-doża ta' Nimenrix ġiet ukoll ikkunsidrata bħala effettiva fit-tfal bejn 12-il ġimgħa u inqas minn 6 xhur.
English: As for all medicines, data on the use of Nimenrix are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Nimenrix hija ssorveljata kontinwament.
English: For children between 6 months and one year of age, the available data allowed to conclude that a single dose of Nimenrix was sufficient to stimulate an immune response against N. meningitidis.
Maltese: Għal tfal ta' eta' bejn 6 xhur u sena, id-data disponibbli ppermettiet li wieħed jikkonkludi li doża waħda ta' Nimenrix kienet biżżejjed biex tistimula rispons immunitarju kontra N. meningitidis.
English: What are the risks associated with Nimenrix?
Maltese: X'inhuma r-riskji assoċjati ma' Nimenrix?
English: How is Nimenrix used?
Maltese: Kif jaħdem Nimenrix?
English: The vaccine contains substances from the outer coat of the bacterium N. meningitidis.
Maltese: Il-vaċċin jinkludi sustanzi mill-kisi ta' barra tal-batterju N. meningitidis.
English: Nimenrix contains small amounts of capsular polysaccharides (sugars from the outer coat) extracted from the four groups of the N. meningitidis bacterium: A, C, W135 and Y. These have been purified and then ‘conjugated' (attached) to a protein carrier called tetanus toxoid (a weakened toxin of tetanus which does not cause disease, also used in tetanus vaccine), because this improves the immune response to the vaccine.
Maltese: Dawn ikunu ġew imsaffija u mbagħad “ikkonjugati” (mehmuża) ma' proteina ġarriera msejħa tossojdu tat-tetnu (tossin imdgħajjef tat-tetnu li ma jikkawżax mard, li jintuża wkoll fil-vaċċin tat-tetnu), għax dan itejjeb ir-rispons immunitarju għallvaċċin.
English: Children from 6 months of age, adolescents and adults should be given one dose of Nimenrix, but an additional dose may be considered for some children at high risk of invasive meningococcal disease (at least 2 months after the last dose of Nimenrix).
Maltese: Tfal minn 6 xhur ‘il fuq, adoloxxenti u adulti għandhom jingħataw doża waħda ta' Nimenrix, iżda tista' tiġi kkunsidrata doża addizzjonali għal xi tfal f'riskju għoli ta' mard meningokokkali invażiv (mill-inqas xahrejn wara l-aħħar doża ta' Nimenrix).
English: A sixth study in over 2,000 children first vaccinated between 6 and 12 weeks of age showed that Nimenrix (given as 2 doses 2 months apart) was as effective as two other vaccines against N. meningitidis in stimulating an immune response.
Maltese: Is-sitt studju fuq aktar minn 2,000 tifel u tifla li tlaqqmu l-ewwel darba meta kellhom bejn 6 ġimgħat u 12-il ġimgħa wera li Nimenrix (mogħti bħala 2 dożi b'xahrejn differenza bejn doża u oħra) kien effettiv daqs iż-żewġ vaċċini l-oħra kontra N. meningitides fl-istimular ta' reazzjoni immuni.
English: Nimenrix is well tolerated and the Agency considered that it can be safely given together with other routinely used vaccines in the different age groups.
Maltese: Nimenrix kien ittollerat tajjeb, u l-Aġenzija qieset li jista' jingħata b'mod sikur flimkien ma' vaċċini oħra użati b'mod regolari fil-gruppi tal-età differenti.
English: Side effects after booster vaccination with Nimenrix are generally similar to those after initial vaccination, but diarrhoea, vomiting and nausea are also very common.
Maltese: L-effetti sekondarji wara t-tilqima booster b'Nimenrix huma ġeneralment simili għal dawk wara t-tilqima inizjali, iżda dijareja, rimettar u nawżja huma komuni ħafna wkoll.
English: For the full list of side effects and restrictions of Nimenrix, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet ta' Nimenrix, ara l-fuljett ta' tagħrif.
English: Vaccines work by preparing the immune system (the body's natural defences) to defend itself against a specific disease.
Maltese: Il-vaċċini jaħdmu billi jippreparaw lis-sistema immunitarja (id-difiżi naturali tal-ġisem) biex tiddefendi ruħha kontra marda speċifika.
English: The Agency noted that Nimenrix offered the benefits of conjugated vaccines over conventional vaccines, including producing a strong immune response in young children.
Maltese: L-Aġenzija nnotat li Nimenrix offra l-benefiċċji ta' vaċċini kkonjugati meta mqabbla ma' vaċċini konvenzjonali, inkluż il-produzzjoni ta' reazzjoni immuni qawwija fit-tfal żgħar.
English: When a person is given the vaccine, the immune system recognises the parts of the bacterium in the vaccine as ‘foreign' and makes antibodies against them.
Maltese: Meta persuna tingħata l-vaċċin, is-sistema immunitarja tagħraf ilpartijiet tal-batterju fil-vaċċin bħala “barranin” u tipproduċi antikorpi kontrihom.
English: The number of people who had an immune response against the polysaccharides with Nimenrix was similar to the other vaccines.
Maltese: L-għadd ta' persuni li kellhom reazzjoni immuni kontra l-polisakkaridi b'Nimenrix kien simili għal vaċċini oħra.
English: In infants from 6 weeks to less than 6 months of age, two doses of Nimenrix are recommended (the first dose is given from 6 weeks of age, the second dose 2 months afterwards).
Maltese: Fi trabi minn ta' bejn 6 ġimgħat u 6 xhur, huma rakkomandati żewġ dożi ta' Nimenrix (l-ewwel doża tingħata minn 6 ġimgħat ‘il fuq, ittieni doża xahrejn wara).
English: EU number
Maltese: EU Numru
English: Immediate Packaging Pack size
Maltese: Mnejn jingħata Il-pakkett immedjat
English: Route of administration
Maltese: Daqs tal-pakkett
English: Statistic
Maltese: Statistika
English: Ciclosporin oral
Maltese: Ciclosporin orali
English: Manufacturer Novartis Pharma GmbH Roonstrasse 25
Maltese: Novartis Pharma GmbH Roonstrasse 25
English: Relative bioavailability/bioequivalence
Maltese: Bijodisponibbiltà/bijoekwivalenza relattiva
English: Temporary dose interruption.
Maltese: Interrompi d-doża temporanjament.
English: Grading based on National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0
Maltese: Il-gradazzjoni mogħtija skont in-National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0
English: Odds ratio (versus placebo)
Maltese: Odds ratio (kontra l-plaċebo)
English: AUC ↓63% (range 0-80%) Cmax ↓58% (range 10-70%)
Maltese: AUC ↓63% (firxa 0-80%) Cmax ↓58% (firxa 10-70%)
English: Votubia 3-7 ng/ml Votubia 9-15 ng/ml Placebo
Maltese: Votubia 3-7 ng/ml Votubia 9-15 ng/ml Plaċebo
English: Antiepileptics (e.g. carbamazepine, phenobarbital, phenytoin)
Maltese: Mediċini antiepilettiċi (eż. carbamazepine, phenobarbital, phenytoin)
English: Grade 2 (≥1x10
Maltese: Grad 2 (≥1x10
English: Independent central review
Maltese: Konsulta ċentrali indipendenti
English: SEGA volume (cm
Maltese: Volum SEGA (ċm
English: Age category
Maltese: Il-kategorija tal-età
English: Includes pneumocystis jirovecii (carinii) pneumonia (PJP, PCP)
Maltese: Inkluż pulmonite kkawżata minn pneumocystis jirovecii (carinii) (PJP, PCP)
English: Haematological parameters
Maltese: Parametri ematoloġiċi
English: Ritonavir, atazanavir, saquinavir, darunavir, indinavir, nelfinavir Moderate CYP3A4/PgP inhibitors Erythromycin
Maltese: Ritonavir, atazanavir, saquinavir, darunavir, indinavir, nelfinavir Impedituri moderati ta' CYP3A4/PgP Erythromycin
English: Final analysis
Maltese: Analiżi finali
English: Response rate (95% CI)
Maltese: Rata ta'rispons (95% CI)
English: Irritability
Maltese: Irritabbiltà
English: The active substance is everolimus.
Maltese: Is-sustanza attiva hi everolimus.
English: No data are available (see sections 5.1 and 5.2).
Maltese: M'hemm l-ebda dejta disponibbli (ara sezzjonijiet 5.1 u 5.2).
English: 25 ml of water
Maltese: 25 ml ta' ilma
English: Adverse reactions are listed according to MedDRA system organ class.
Maltese: Reazzjonijiet avversi qed jitniżżlu skont is-sistema ta' klassifika tal-organi MEDRA.
English: The use of corticosteroids may be indicated.
Maltese: Lużu ta' kortikosterojdi jista' jkun indikat.
English: ≥18 years b n=21
Maltese: ≥18-il sena b n=21
English: Family-wise error rate of 2.5% one-sided
Maltese: Rata ta' żball family-wise ta' 2.5% fuq naħa waħda
English: ≤5 ng/ml >5 ng/ml Difference Difference is “≤5 ng/ml” minus “>5 ng/ml”
Maltese: Id-differenza hi ta' “≤5 ng/ml” minus “>5 ng/ml”
English: Placebo p-value Votubia n=79
Maltese: Plaċebo valur-p Votubia n=79
English: Primary analysis for double blind period
Maltese: Analiżi primarja għall-perjodu double blind
English: Grade 2 (<75, ≥50x10
Maltese: Grad 2 (<75, ≥50x10 9/l)
English: Statistically significant per Bonferroni-Holm procedure d
Maltese: Statistikament sinjifikanti skont il-proċedura Bonferroni-Holm d
English: Final analysis Votubia Placebo p-value Votubia N=78
Maltese: Analiżi finali Votubia Plaċebo valur-p Votubia N=78
English: Primary analysis
Maltese: Analiżi primarja
English: Table 4 Adverse reactions reported in TSC studies
Maltese: Tabella 4 Reazzjonijiet avversi rrappurtati waqt studji TSC
English: Light fat meals reduced AUC by 32% and Cmax by 42%.
Maltese: Ikliet bi ftit xaħam naqqsu l-AUC bi 32% u s-Cmax bi 42%.
English: 75% resp. 75 to <100
Maltese: 75% risp. 75 sa <100
English: Reproductive system and breast disorders Very common Amenorrhoea d, menstruation irregular d
Maltese: Disturbi fis-sistema riproduttiva u fis-sider Komuni ħafna Amenorrea d, mestrwazzjoni irregolari d
English: Thirteen patients (46%) had a secondary smaller SEGA, including 12 in the contralateral ventricle.
Maltese: Tlettax-il pazjent (46%) kellhom SEGA sekondarja iżgħar, inkluż 12 fil-ventrikolu kontrolaterali.
English: ≥6 years
Maltese: ≥6 snin
English: <6 years n=33
Maltese: <6 snin n=33
English: A total of 118 patients were randomised, 79 to Votubia 10 mg daily and 39 to placebo.
Maltese: Total ta' 118-il pazjent kienu randomizzati, 79 għal Votubia 10 mg kuljum u 39 għal placebo.
English: (see sections 4.2 and 5.2).
Maltese: (ara sezzjonijiet 4.4 u 5.2).
English: Baseline n=28
Maltese: Linja bażi n=28
English: 25% resp. 25 to <50
Maltese: 25% risp. 25 sa <50
English: In vitro, everolimus is a competitive inhibitor of CYP3A4 and a mixed inhibitor of CYP2D6.
Maltese: In vitro, everolimus huwa impeditur kompetittiv ta' CYP3A4 u impeditur imħallat ta' CYP2D6.
English: Table 3 Adverse reactions reported in TSC studies
Maltese: Tabella 3 Reazzjonijiet avversi rrappurtati waqt studji TSC
English: Odds ratio >1 favours everolimus arm.
Maltese: Odds ratio >1 tiffavorixxi l-grupp mogħti everolimus.
English: AUC ↑ 3.7-fold Cmax ↑ 2.2-fold
Maltese: AUC ↑ 3.7 drabi Cmax ↑ 2.2 drabi
English: In EXIST-3 (Study CRAD001M2304), everolimus increased pre-dose concentrations of the antiepileptics carbamazepine, clobazam, and the clobazam metabolite N-desmethylclobazam by about 10%.
Maltese: F'EXIST-3 (Studju CRAD001M2304), Everolimus żied il-konċentrazzjonijiet ta' qabel id-doża talmediċini antiepilettiċi carbamazepine, clobazam, u l-metabolit ta' clobazam N-desmethylclobazam b'madwar 10%.
English: Everolimus binds to the intracellular protein FKBP-12, forming a complex that inhibits mTOR complex-1 (mTORC1) activity.
Maltese: Everolimus jeħel mal-proteina intraċellulari FKBP-12, u jifforma kumpless li jimpedixxi l-attività ta' mTOR complex-1 (mTORC1).
English: 50% resp. 50 to <75
Maltese: 50% risp. 50 sa <75
English: Non-infectious pneumonitis is a class effect of rapamycin derivatives, including everolimus.
Maltese: Pulmonite mhux infettiva hija effett tal-klassi tad-derivattivi ta' rapamycin, inkluż everolimus.
English: Time-averaged Cmin category
Maltese: Kategorija żmien-Cmin medja
English: Exact 95% CI obtained using Clopper-Pearson method b
Maltese: Intuża l-metodu Clopper-Pearson biex tinkiseb 95% CI eżatti b
English: Pharmacotherapeutic group: Antineoplastic agents, other antineoplastic agents, protein kinase inhibitors, ATC code: L01XE10
Maltese: Aġenti anti-neoplastiċi, aġenti anti- neoplastiċi oħrajn, inibituri talproteina kinasi, Kodiċi ATC: L01XE10
English: Grade 4
Maltese: Grad 4
English: Active substance by interaction
Maltese: Sustanza attiva skont linterazzjoni
English: Frequency categories are defined using the following convention: 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); not known (cannot be estimated from the available data).
Maltese: Ilkategoriji tal-frekwenzi huma ddefiniti skont il-konvenzjoni li ġejja: 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); mhux magħruf (ma tistax tittieħed stima mid-dejta disponibbli).
English: Impaired wound healing is a class effect of rapamycin derivatives, including Votubia.
Maltese: In-nuqqas ta' fejqan ta' feriti huwa effett tal-klassi tad-derivattivi ta' rapamycin, inkluż Votubia.
English: The grades follow CTCAE Version 3.0 and 4.03.
Maltese: Il-gradi jsegwu l-Verżjoni 3.0 u 4.03 ta' CTCAE.
English: Concomitant ketogenic diet
Maltese: Dieta ketoġenika konkomitanti
English: Month 48 n=24
Maltese: 48 Xahar n=24
English: Table 6 EXIST-3 - Seizure frequency response rate by age
Maltese: Tabella 6 EXIST-3 - Ir-rata ta' rispons tal-frekwenza tal-epilessija skont l-età
English: Odds ratio and its 95% CI obtained using logistic regression stratified by age subgroup.
Maltese: Odds ratio u l-95% CI tagħha nkisbu billi ntużat rigressjoni loġistika skont is-sottogruppi tal-età.
English: The median age for the total population was 10.1 years (range: 2.2-56.3; 28.4% <6 years, 30.9% 6 to <12 years, 22.4% 12 to <18 years and 18.3% >18 years).
Maltese: L-età medja tal-popolazzjoni sħiħa kienet ta' 10.1 snin (medda: 2.2-56.3; 28.4% <6 snin, 30.9% 6 sa <12-il sena, 22.4% 12 sa <18-il sena u 18.3% >18-il sena).
English: Table 7 EXIST-1 - SEGA response
Maltese: Tabella 7 EXIST-1 - Rispons SEGA
English: Using an oral syringe
Maltese: Użu ta' siringa orali
English: On rare occasions, fatal outcomes were observed in the oncology setting (see section 4.4).
Maltese: F'każijiet rari, kienu osservati riżultati fatali f'sitwazzjoni onkoloġika (ara sezzjoni 4.4).
English: 6 to <12 years n=37
Maltese: 6 sa <12-il sena n=37
English: The other ingredients are butylated hydroxytoluene (E321), magnesium stearate, lactose monohydrate, hypromellose, crospovidone type A, mannitol, cellulose microcrystalline and silica colloidal anhydrous.
Maltese: Is-sustanzi l-oħra huma butylated hydroxytoluene (E321), magnesium stearate, lactose monohydrate, hypromellose, crospovidone type A, mannitol, cellulose microcrystalline u silica colloidal anhydrous.
English: Table 6 EXIST-1 - SEGA response
Maltese: Tabella 6 EXIST-1 - Rispons SEGA