FrancophonIA/ELRC3.0 huggingface dataset:
English: The pharmacokinetics of alemtuzumab were evaluated in a total of 216 patients with RRMS who received intravenous infusions of either 12 mg/day or 24 mg/day on 5 consecutive days, followed by 3 consecutive days 12 months following the initial treatment course.
Maltese: .2 Tagħrif farmakokinetiku Il-farmakokinetika ta' alemtuzumab ġiet evalwati f'total ta' 216-il pazjent b'RRMS li rċivew infużjonijiet ġol-vini ta' 12-il mg/jum jew 24 mg/jum fuq 5 ijiem konsekuttivi, segwiti minn 3 ijiem konsekuttivi
English: Erythema*, ecchymosis, alopecia, hyperhidrosis, acne, skin lesion, dermatitis
Maltese: iperidrosi, akne, ferita fil ġilda, dermatite
English: Patients with 6-month CDW (95% CI)
Maltese: Pazjenti li ma kellhom l-ebda rikaduta f'Sena 2 (95% CI)
English: Thyroid endocrine disorders including autoimmune thyroid disorders have been observed in 36.8% of patients treated with LEMTRADA 12 mg in clinical trials in MS with a median of 6.1 years (maximum 12 years) of follow- up from the first LEMTRADA exposure.
Maltese: Disturbi tat-tirojde Disturbi endokrinarji tat-tirojde inklużi disturbi awtoimmuni tat-tirojde ġew osservati f'36.8% ta' pazjenti kkurati bi 12-il mg LEMTRADA fi provi kliniċi b'MS b'medjan ta' 6.1 snin (massimu ta' 12-il sena) ta' segwitu mill-ewwel esponiment għal LEMTRADA.
English: No data are available on the association of LEMTRADA with Hepatitis B virus (HBV) or Hepatitis C virus (HCV) reactivation as patients with evidence of active or chronic infections were excluded from clinical trials.
Maltese: Epatite B (HBV) jew mal-virus tal-Epatite Ċ (HCV) għax pazjenti b'evidenza ta' infezzjonijiet attivi jew kroniċi ġew esklużi mill-provi kliniċi.
English: Sanofi AB Tel: +46 (0)8 634 50 00
Maltese: Tel: +46 (0)8 634 50 00
English: Relapse severity
Maltese: Severità tar-rikaduta
English: Lymphadenopath y, immune thrombocytopeni c purpura, thrombocytopeni a, anaemia haematocrit decreased, leukocytosis
Maltese: Limfadenopatij a, purpura tromboċitopeni ka immuni,
English: The requirements for submission of PSURs for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: PSURs għal dan il-prodott mediċinali huma mniżżla fil-lista tad dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva
English: In clinical trials, patients were pre-treated with 1,000 mg methylprednisolone for the first 3 days of each LEMTRADA treatment course.
Maltese: Fil-provi kliniċi, il-pazjenti ġew ikkurati minn qabel b'1,000 mg ta' methylprednisolone għall-ewwel 3 ijiem ta' kull kors ta' kura b'LEMTRADA.
English: Approximately 40% of patients had total lymphocyte counts reaching the lower limit of normal (LLN) by 6 months after each treatment course, and approximately 80% of patients had total lymphocyte counts reaching the LLN by 12 months after each course.
Maltese: Madwar 40% tal-pazjenti kellhom għadd totali ta' limfoċiti li laħaq il-limitu t'isfel tan-normal (LLN) sa 6 xhur wara kull kors ta' kura, u madwar 80% tal-pazjenti kellhom għadd totali ta' limfoċiti li laħaq l-LLN sa 12-il xahar wara kull kors.
English: For instructions on dilution of the medicinal product before administration, see section 6.6.
Maltese: Għal struzzjonijiet fuq id-dilwizzjoni tal-prodott mediċinali qabel l-amministrazzjoni, ara sezzjoni 6.6.
English: 4 years * Defined as patients having experienced at least 1 relapse during treatment with beta interferon or glatiramer acetate after having been on therapy with medicinal product for at least 6 months.
Maltese: 4 snin * Definit bħala pazjenti li kellhom mill-inqas rikaduta waħda matul il-kura b'beta interferon jew glatiramer acetate wara li kienu ilhom fuq terapija bil-prodott mediċinali għal mill-inqas 6 xhur. ‡
English: LEMTRADA 12 mg (N=376)
Maltese: (N=376)
English: Including follow-up in Study 4, patients originally treated with LEMTRADA in Studies 1 and 2, respectively, had ARRs 0.17 and 0.23, CDW was seen in 22.3% and 29.7%, while 32.7% and 42.5% achieved CDI.
Maltese: Inkluż is-segwitu fl-Istudju 4, il-pazjenti li oriġinarjament kienu ġew ittrattati b'LEMTRADA fl-Istudji 1 u 2, rispettivament, kellhom ARRs 0.17 u 0.23, CDW deher fi 22.3% u 29.7%, filwaqt li 32.7% u 42.5% kisbu CDI. F'kull sena tal-Istudju 4, pazjenti miż-żewġ studji komplew juru riskju baxx li jiffurmaw leżjonijiet T2 (27.4% to 33.2%) jew leżjonijiet li jidhru aħjar b'gadolinium
English: Alemtuzumab is an IgG1 kappa antibody with human variable framework and constant regions, and complementary-determining regions from a murine (rat) monoclonal antibody.
Maltese: IgG1 b'qafas varjabbli uman u reġjuni kostanti, u reġjuni determinanti kumplimentari minn antikorp monoklonali ta' annimal gerriemi (far).
English: Hypotension*, hypertension*
Maltese: Puplesija emorraġika**,
English: LEMTRADA 12 mg/day led to significantly lower EDSS scores (improved compared to baseline) through 2 years of follow up, compared with IFNB-1a (p<0.0001).
Maltese: LEMTRADA 12-il mg/jum wassal għal punteġġi ta' EDSS li kienu iktar baxxi b'mod sinifikanti (imtejba meta mqabbla mal-linja bażi) sa sentejn ta' segwir, meta mqabbel ma' IFNB-1a (p<0.
English: LEMTRADA contains the active substance alemtuzumab, which is used to treat a form of multiple sclerosis (MS) in adults, called relapsing remitting multiple sclerosis (RRMS).
Maltese: fl-adulti, li tissejjaħ sklerosi multipla li tirkadi u tbatti (RRMS- relapsing remitting multiple sclerosis ).
English: infections, gastroenteritis, oral candidiasis, vulvovaginal candidiasis, influenza, ear infection, pneumonia, vaginal infection, tooth infection tonsillitis, acute sinusitis, cellulitis, pneumonitis, tuberculosis, cytomegalovirus infection virus (EBV) reactivation
Maltese: • Infezzjonijiet: influwenza fl-istonku, infjammazzjoni fil-ħanek, fungu fid-dwiefer, infjammazzjoni fit-tunsilli, sinożite akuta, infezzjoni bil-batterji fil-ġilda, pulmonite, infezzjoni b'cytomegalovirus
English: Study population
Maltese: Investigazzjon ijiet
English: The safety and efficacy of LEMTRADA in children with MS aged 0 to 18 years have not yet been established.
Maltese: Is-sigurtà u l-effikaċja ta' LEMTRADA fit-tfal b'MS minn età ta' 0 sa 18-il sena ma ġewx determinati s'issa.
English: Headache*
Maltese: Dardir*
English: For these patients, the ARR declined from 0.79 in the year prior to Course 3 to 0.18 one year after, and the mean EDSS score from 2.89 to 2.69.
Maltese: Għal dawn il-pazjenti, l-ARR naqas minn 0.79 fis-sena ta' qabel Kors 3 sa 0.18 sena wara, u l-medja tal punteġġ ta' EDSS minn 2.89 sa 2.69.
English: Infections occurred in 71% of patients treated with LEMTRADA 12 mg as compared to 53% of patients treated with subcutaneous interferon beta-1a [IFNB 1a](44mcg 3-times weekly) in controlled clinical trials in MS up to 2 years in duration and were predominantly mild to moderate in severity.
Maltese: Infezzjonijiet seħħew f'71% tal-pazjenti kkurati bi 12-il mg LEMTRADA meta mqabbla ma' 53% talpazjenti kkurati b'interferon beta-1a
English: In alignment with the effect on relapse rate, supportive analyses from Study 1 (CAMMS323) showed that LEMTRADA 12 mg/day led to significantly fewer LEMTRADA -treated patients experiencing severe relapses (61% reduction, p=0.0056) and signficantly fewer relapses that led to steroid treatment (58%
Maltese: F'allinjament mal-effett fuq ir-rata ta' rikaduta, analiżijiet ta' appoġġ minn Studju 1 (CAMMS323) urew li LEMTRADA 12-il mg/jum wassal għal numru sinifikanti inqas ta' pazjenti kkurati b'LEMTRADA li kellhom rikaduti severi (tnaqqis ta' 61%, p=0.0056) u numru sinifikanti inqas ta' rikaduti li wasslu għal kura bi sterojdi (tnaqqis ta' 58%, p<0.0001) meta mqabbel ma' IFNB-1a.
English: Screening for tuberculosis will be arranged by your doctor.
Maltese: Pazjenti b'passat mediku ta' puplesija.
English: Clinical examination and laboratory tests should be conducted at periodic intervals until at least 48 months following the last treatment course of LEMTRADA in order to monitor for early signs of autoimmune diseases:
Maltese: Testijiet tal-laboratorju rakkomandati għal monitoraġġ ta' pazjenti Eżaminazzjoni klinika u testijiet tal-laboratorju għandhom isiru f'intervalli perjodiċi sa mill-inqas 48 xahar wara l-aħħar kors ta' kura b'LEMTRADA sabiex isir monitoraġġ għal sinjali bikrin ta' mard awtoimmuni:
English: Clinical manifestations of nephropathy may include elevation in serum creatinine, haematuria, and/or proteinuria.
Maltese: Manifestazzjonijiet kliniċi ta' newropatija jistgħu jinkludu żieda fil-livell ta' kreatinina fis-serum, ematurija, u/jew proteinurija.
English: Metabolism and nutrition disorders
Maltese: Disturbi fil metaboliżmu u n-nutrizzjoni
English: % receiving ≥2 prior MS
Maltese: % li rċivew ≥2 terapiji preċedenti għal MS
English: Patients treated with LEMTRADA have had infections due to a virus called Epstein-Barr virus (EBV), including cases with severe liver inflammation.
Maltese: Pazjenti ttrattati b'LEMTRADA kellhom infezzjonijiet ikkawżati minn virus li jissejjaħ Epstein Barr virus (EBV), li jinkludu każijiet b'infjammazzjoni severa tal-fwied.
English: These are described in section 4.4.
Maltese: f'sezzjoni 4.4).
English: Suomi/Finland
Maltese: Suomi/Finland Sanofi Oy
English: This analysis includes data from Phase 3 studies only (CAMMS324 and CAMMS323) due to differences in the MRI acquisition algorithms between the Phase 2 and Phase 3 studies.
Maltese: Din l-analiżi tinkludi dejta mill-istudji ta' Fażi 3 biss (CAMMS324 u CAMMS323)
English: A risk to the suckling newborn/infant cannot be excluded.
Maltese: Ir-riskju gћattarbija/tarbija tat-twelid li qed terda' mhux eskluż.
English: Treatment-naïve patients Patients with inadequate response to prior therapy*
Maltese: Pazjenti b'rispons inadegwat għat-terapija preċedenti*
English: Sanofi S.p.A. Tel: 800536389
Maltese: Tel: 800536389
English: In the subgroup of RRMS patients with 2 or more relapses in the prior year and at least 1 Gd-enhanced T1 lesion at baseline, the annualised relapse rate was 0.26 (95% CI: 0.20, 0.34) in the Lemtrada treated group (n
Maltese: waħda fil-linja bażi li tidher bil-Gadolimium, ir-rata ta' rikaduta f'sena kienet ta' 0.26 (95% CI: 0.20, 0.34) fil-grupp ittrattat b'Lemtrada
English: • Inflammation of the gallbladder
Maltese: • Reazzjonijiet għall-infużjoni
English: In female mice dosed with intravenous alemtuzumab up to 10 mg/kg/day (AUC of 4.7 times the human exposure at the recommended daily dose) for 5 consecutive days prior to cohabitation with wild-type male mice, the average number of corpora lutea and implantation sites per mouse were significantly reduced as compared to vehicle treated animals.
Maltese: Fi ġrieden nisa li ngħataw dożi ta' alemtuzumab sa 10 mg/kg/jum mogħtija minn ġol-vini (AUC ta' 4.7 darbiet tal-esponiment fil-bniedem bid-doża rakkomandata ta' kuljum) għal 5 ijiem konsekuttivi qabel il-koabitazzjoni ma' ġrieden irġiel li jinstabu fin-natura, il-medja tan-numru ta' corpora lutea u siti ta'
English: 3 Estimated using a mixed model for repeated measures.
Maltese: 3 Stmata permezz tal-użu ta' mudell imħallat għal kejl ripetut.
English: o Thyroid disorders
Maltese: o Disturbi tat-tirojde
English: CD3+ and CD4+ lymphocyte counts rise more slowly towards normal, but generally do not return to baseline by 12months post-treatment.
Maltese: L-għadd ta' limfoċiti CD3 + u CD4 + jogħla iktar bil-mod lejn il-livell normali, iżda ġeneralment ma jirritornax għallinja bażi sa 12-il xahar wara l-kura.
English: Serious and sometimes fatal IARs including bronchospasm, hypoxia, syncope, pulmonary infiltrates, acute respiratory distress syndrome , respiratory arrest, myocardial infarction, arrhythmias, acute cardiac insufficiency, and cardiac arrest have been observed in non-MS patients treated with alemtuzumab at higher and more frequent doses than used in MS.
Maltese: IARs serji u xi kultat fatali li jinkludu bronkospażmu, ipoksja, sinkope, infiltrati pulmonari, sindrome ta' għeja respiratorja akuta, waqfien respiratorju, infart mijokardijaku, arritmiji, insuffiċjenza kardijaka akuta, u waqfien kardijaku ġew osservati f'pazjenti li ma kellhomx MS ikkurati b'alemtuzumab f'dożi ogħla u iktar frekwenti minn dawk użati f'MS.
English: This medicine contains less than 1 mmol potassium (39 mg) per infusion, i.e. it is essentially ‘potassiumfree'.
Maltese: Din il-mediċina fiha anqas minn mmol 1 ta' potassium (39 mg) f'kull infużjoni, i.e. hi essenzjalment
English: Table 3: Key Clinical and MRI Endpoints from Studies 1 and 2 Study 1
Maltese: Tabella 1: Reazzjonijiet avversi fi studju 1, 2, 3 u 4 osservati f'≥0.
English: 4.6 Fertility, pregnancy and lactation
Maltese: .6 Fertilità, tqala u treddigħ Nisa li jistgħu joħorġu tqal
English: • difficulty swallowing, throat irritation, productive cough
Maltese: • diffikultà biex tibla', irritazzjoni fil-gerżuma, sogħla bil-katarru
English: The other ingredients are:
Maltese: - Każijiet fatali:
English: LEMTRADA 12 mg (N=426)
Maltese: (N=426)
English: Administer within 8 hours after dilution.
Maltese: Agħti fi żmien 8 sigħat wara d-dilwizzjoni.
English: Cytomegalovirus infections (CMV) including cases of CMV reactivation have been reported in LEMTRADA-treated patients.
Maltese: Infezzjonijiet b'Cytomegalovirus (CMV) li jinkludi każijiet ta' reattivazzjoni ta' CMV ġew irrapportati f'pazjenti ttrattati b'Lemtrada.
English: Additional course(s) of LEMTRADA were administered at 12 mg/day for 3 consecutive days (36 mg total dose) at least 12 months after the prior treatment course.
Maltese: LEMTRADA ingħataw bid-doża ta' 12-il mg/kuljum għal 3 ijiem konsekuttivi (doża totali ta' 36 mg)
English: Nausea*
Maltese: emigranja*
English: A reproductive toxicity study in pregnant mice exposed to intravenous doses of alemtuzumab up to 10 mg/kg/day (AUC 2.4 times the human exposure at the recommended dose of 12 mg/day) for 5 consecutive days during gestation resulted in significant increases in the number of dams with all conceptuses dead or resorbed, along with a concomitant reduction in the number of dams with viable foetuses.
Maltese: 10 mg/kg/jum mogħtija minn ġol-vini (AUC ta' 2.4 darbiet tal-esponiment fil-bniedem bid-doża rakkomandata ta' 12-il mg/jum) għal 5 ijiem konsekuttivi matul it-tqala, wassal għal żidiet sinifikanti finnumru ta' ommijiet ġrieden bil-feti kollha mejtin jew assorbiti mill-ġdid, flimkien ma' tnaqqis fl-istess ħin fin-numru ta' ommijiet ġrieden b'feti vijabbli.
English: • First treatment course: 12 mg/day on 5 consecutive days (60 mg total dose)
Maltese: L-ewwel kors ta' kura: 12-il mg/jum f'5 ijiem konsekuttivi (doża totali ta' 60 mg)
English: LEMTRADA is indicated as a single disease modifying therapy in adults with highly active relapsing remitting multiple sclerosis (RRMS) for the following patient groups:
Maltese: LEMTRADA hu indikat bħala terapija waħidha ta' immodifikar tal-marda fl-adulti bi sklerożi multipla attiva ħafna li tirkadi u tbatti (RRMS-relapsing remitting multiple sclerosis) fil-gruppi ta' pazjenti li ġejjin:
English: Treatment consists of discontinuation of the medicinal product and supportive therapy.
Maltese: Il-kura tikkonsisti fit-twaqqif tal prodott mediċinali u terapija ta' appoġġ.
English: Animal data have shown effects on fertility in humanised mice (see section 5.3), however a potential impact on human fertility during the period of exposure is unknown based on the available data.
Maltese: Dejta dwar l-annimali wriet effetti fuq il-fertilità fi ġrieden umanizzati (ara sezzjoni 5.3), madankollu mhux magħruf jekk hemmx impatt potenzjali fuq il-fertilità umana matul il-perjodu ta' esponiment ibbażat fuq id-dejta disponibbli.
English: 2 Patient Guide:
Maltese: Kategorija farmakoterapewtika:
English: Alemtuzumab is a protein for which the expected metabolic pathway is degradation to small peptides and individual amino acids by widely distributed proteolytic enzymes.
Maltese: Alemtuzumab hu proteina li għaliha r-rotta metabolika mistennija hi degradazzjoni għal peptides żgħar u amino acids individwali minn enzimi proteolitiċi ddistribwiti b'mod mifrux.
English: comparing Lemtrada to an adequate control.
Maltese: Pazjenti b'ipertensjoni mhux ikkontrollata.
English: LEMTRADA is supplied in a clear, 2 ml glass vial, with a butyl rubber stopper and aluminium seal with a plastic flip-off cap.
Maltese: LEMTRADA hu fornut f'kunjett tal-ħġieġ ċar ta' 2 ml, b'tapp tal-lastku tal-butyl u siġill tal-aluminju b'għatu tal-plastik flip-off.
English: ANNEX III LABELLING AND PACKAGE LEAFLET
Maltese: KARTUNA TA' BARRA/PAKKETT
English: Follow-up month
Maltese: 12 settembru 2013
English: At 3 years, LEMTRADA reduced the risk of 6-month CDW by 76% (hazard ratio 0.24 [95% CI: 0.110,
Maltese: (Konferma li d-Diżabilità Qed Tmur għall-Agħar [CDW, Confirmed Disability Worsening] 2 Pazjenti b'CDW ta' 6 xhur (95% CI) Proporzjon ta' periklu (95% CI)
English: Serious reactions occurred in 3% of patients and included cases of headache, pyrexia, urticaria, tachycardia, atrial fibrillation, nausea, chest discomfort, and hypotension.
Maltese: Reazzjonijiet serji seħħew fi 3% tal-pazjenti u kienu jinkludu każijiet ta' uġigħ ta' ras, deni, urtikarja, takikardija, fibrillazzjoni atrijali, dardir, skumdità fis sider, u pressjoni baxxa.
English: Baseline characteristics
Maltese: KLASSIFIKAZZJONI ĠENERALI
English: Signs and symptoms of thyroid disorders are described in section 4.
Maltese: Sinjali u sintomi ta' disturbi tat-tirojde huma deskritti f'sezzjoni 4.
English: • Third or fourth course: 12 mg/day on 3 consecutive days (36 mg total dose) administered at least
Maltese: It-tieni kors ta' kura: 12-il mg/jum f'3 ijiem konsekuttivi (doża totali ta' 36 mg) mogħtija
English: Acute acalculous cholecystitis
Maltese: Koleċistite akalkuluża akuta
English: Time to onset of CDI was defined as a decrease of at least one point on the EDSS from a baseline EDSS score ≥ 2 that was sustained for at least 6 months.
Maltese: Żmien sal-bidu ta' CDI ġie definit bħala tnaqqis ta' mill-inqas punt wieħed fuq l-EDSS minn punteġġ EDSS fil-linja bażi ta' ≥ 2 li kien sostnut għal mill-inqas 6 xhur.
English: Autoimmune events reported in alemtuzumab-treated patients include neutropenia, haemolytic anaemia (including a fatal case), acquired haemophilia, anti-GBM disease, and thyroid disease.
Maltese: Mard awtoimmuni Avvenimenti awtoimmuni rrappurtati f'pazjenti kkurati b'alemtuzumab jinkludu newtropenija, anemija emolitika (li tinkludi każ fatali), emofilija miksuba, mard kontra GBM, u mard tat-tirojde.
English: Nephropathies, including anti-glomerular basement membrane (anti-GBM) disease, have been observed in 6 (0.4%) patients in clinical trials in MS through a median of 6.1 years (maximum 12 years) of follow-up and generally occurred within 39 months following the last administration of LEMTRADA.
Maltese: Nefropatiji, li jinkludu l-marda tal-membrana basement antiglomerulari (anti-GBM), ġew osservati f'6 pazjenti (0.4%) fi provi kliniċi f'MS permezz ta' medjan ta' 6.1 snin (massimu ta' 12-il sena) ta'
English: Cholecystitis including acalculous cholecystitis and acute acalculous cholecystitis
Maltese: Koleċistite inkluża koleċistite akalkuloża u koleċistite akalkuloża akuta
English: Relapse Rate1
Maltese: Diżabilità1
English: Figure 1: Time to 6 Month Confirmed Disability Worsening in Study 2
Maltese: Figura 1: Żmien għall-Konferma li d-Diżabilità Qed Tmur għall-Agħar ara 6 xhur fi Studju 2
English: • bleeding in lungs
Maltese: pulmonite,
English: • heartburn
Maltese: • tbenġila
English: Patients with active MS, defined as at least 2 relapses within the prior 2 years.
Maltese: Pazjenti b'MS attiva, definita bħala mill-inqas 2 rikaduti fis-sentejn ta' qabel.
English: Each vial contains 12 mg alemtuzumab in 1.2 ml.
Maltese: Kull kunjett fih 12 mg ta' alemtuzumab f'1.2 ml.
English: Pneumonitis (inflammation of lung tissue) has been reported in LEMTRADA treated patients.
Maltese: Pulmonite (infjammazzjoni tat-tessut tal-pulmun) ġiet irrappurtata f'pazjenti ttrattati b'LEMTRADA.
English: o Liver inflammation
Maltese: Infezzjonijiet u infestazzjonijiet
English: Some patients have developed liver inflammation after receiving LEMTRADA.
Maltese: Ġiet irrappurtata pulmonite f'pazjenti li rċivew infużjonijiet ta' LEMTRADA.
English: Reported autoimmune conditions, include thyroid disorders, immune thrombocytopenic purpura (ITP), nephropathies (e.g. anti-glomerular basement membrane disease), autoimmune hepatitis (AIH), and acquired haemophilia A. In the post-marketing setting, patients developing multiple autoimmune disorders after LEMTRADA treatment have been observed.
Maltese: Kundizzjonijiet li ġew irrapportati jinkludu disturbi tat-tirojde, purpura tromboċitopenika immuni (ITP), nefropatiji (eż., marda tal-membrana basement antiglomerulari), epatite awtoimmuni (EAI) u emofilja A akkwiżita.
English: Abdominal pain, vomiting, diarrhoea dyspepsia*, stomatitis
Maltese: influwenza, infezzjoni filwidnejn, pulmonite, infezzjoni fil vaġina,
English: 46.6% of the patients initially treated with LEMTRADA 12 mg/day in Study 1 or 2 received additional courses upon documented evidence of MS disease activity (relapse and/or MRI) and the treating physician's decision to retreat.
Maltese: 46.6% tal-pazjenti li fil-bidu kienu ġew ittrattati b'LEMTRADA 12-il mg/kuljum fl-Istudju 1 jew 2 irċivew korsijiet addizzjonali malli kien hemm xhieda ddokumentata ta' attività tal-marda ta' MS
English: Chest discomfort*, pain*, oedema peripheral,
Maltese: Skumdità fis sider*, uġigħ*,
English: Sanofi Oy Puh/Tel: + 358 201 200 300
Maltese: Slovenija sanofi-aventis d.o.o. Tel: +386 1 560 4800
English: 91.8% of the patients treated with LEMTRADA 12 mg in Studies 1 and 2 entered Study 4.
Maltese: 91.8 % tal-pazjenti trattati b'LEMTRADA 12-il mg fl-Istudji 1 u 2 daħlu fl-Istudju 4. 82.7% minn dawn il-pazjenti temmew l-istudju.
English: BATCH NUMBER
Maltese: Ma japplikax
English: Nephropathies
Maltese: Il-Belġju
English: • You should monitor their test results and remain vigilant for symptoms of adverse events.
Maltese: • Għandek timmonitorja r-riżultati tat-testijiet tagħhom u tibqa' viġilanti għal sintomi ta'
English: For intravenous administration, withdraw 1.2 ml of LEMTRADA from the vial into a syringe using aseptic technique.
Maltese: Għal għoti ġol-vina, iġbed 1.2 ml ta' LEMTRADA mill-kunjett għal ġo siringa billi tuża teknika asettika.
English: Treatment with intravenous alemtuzumab at doses up to 10 mg/kg/day, administered for 5 consecutive days (AUC of 7.1 times the human exposure at the recommended daily dose) had no effect on fertility and reproductive performance in male huCD52 transgenic mice.
Maltese: (AUC ta' 7.1 darbiet tal-esponiment fil-bniedem fid-doża rakkomandata ta' kuljum) ma kellha l-ebda effett fuq il-fertilità u l-prestazzjoni riproduttiva fi ġrieden transġeniċi rġiel huCD52.
English: 5.2 Pharmacokinetic properties
Maltese: GĦAMLA FARMAĊEWTIKA
English: • general discomfort, weakness, vomiting, diarrhoea, abdominal pain, gastric flu, hiccups
Maltese: • skonfort ġenerali, dgħufija, rimettar, dijarea, uġigħ ta' żaqq, influwenza gastrika, sulluzzu
English: Patients had an EDSS from 0-3.0, at least 2 clinical episodes of MS in the prior 2 years, and ≥1 gadolinium-enhancing lesion at study entry.
Maltese: Il-pazjenti kellhom EDSS minn 0-3.0, mill-inqas 2 episodji kliniċi ta' MS matul is sentejn ta' qabel, u ≥1 leżjoni li tidher aktar b'gadolinium meta daħlu fl-istudju.
English: Posology
Maltese: LEMTRADA
English: What is multiple sclerosis?
Maltese: X'inhi l-isklerożi multipla?
English: • If the patient shows clinical symptoms suggesting development of a serious adverse event associated with the infusion (myocardial ischemia, hemorrhagic stroke, cervico-cephalic arterial dissection or pulmonary alveolar haemorrhage
Maltese: • Jekk il-pazjent juri sintomi kliniċi li jissuġġerixxu l-iżvilupp ta' avveniment avvers serju assoċjat mal-infużjoni (iskemija mijokardjali, puplesija emorraġika, dissezzjoni arterjali ċerviko-ċefalika jew emorraġija alveolari pulmonarja)