FrancophonIA/ELRC3.0 huggingface dataset:
English: Experience with the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc. demonstrates that antibodies to measles, mumps, and rubella viruses are still detectable in most individuals 11 to 13 years after primary vaccination.
Maltese: L-esperjenza bil-vaċċin tal-ħosba, gattone, u rubella mmanifatturata minn Merck & Co., Inc. turi li antikorpi għall-virus tal-ħosba, gattone, u rubella għadhom jiġu osservati f'ħafna individwi 11 sa 13-il sena wara l-ewwel tilqima.
English: Nerve deafness
Maltese: TAGĦRIF
English: It has been reported that live attenuated measles, mumps and rubella virus vaccines given individually may result in a temporary depression of tuberculin skin sensitivity.
Maltese: Kien hemm rapporti li meta l-vaċċini ħajjin tal-virus tal-ħosba, gattone u rubella jingħataw individwalment, dan jista' jwassal għal tnaqqis temporanju fis-sensittività tal-ġilda għat-tuberkulina.
English: 20 vials (powder) + 20 pre-filled syringes (solvent)+ 20 needles.
Maltese: 20 kunjett (trab) + 20 siringa mimlijin għal-lest (solvent) + 20 labra.
English: Powder in a vial (glass) with a stopper (butyl rubber) and solvent in a pre-filled syringe (glass) with plunger stopper (chlorobutyl rubber) and tip cap (styrene-butadiene rubber), with one or two unattached needles, in a pack size of 1, 10 and 20.
Maltese: Trab f'kunjett (ħġieġ) b'tapp (lastku butyl) u solvent f'siringa mimlija għal-lest (ħġieġ) b'tapp talplanġer (lastku chlorobutyl) u għatu tat-tarf (lastku styrene-butadiene), b'labra waħda jew tnejn mhux imqabbdin, f'pakkett b'daqs ta' 1, 10, u 20.
English: Children who received ProQuad at 4 through 6 years of age after primary vaccination with Varicella Vaccine live (Oka/Merck) and the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc.
Maltese: Tfal ta' età bejn l-4 u s-6 snin li ħadu ProQuad wara l-ewwel tilqima bil-Varicella Vaccine live (Oka/Merck) u l-vaċċin tal-ħosba, gattone jew rubella mmanifatturata minn Merck &Co., Inc.
English: Following ProQuad given alone in 7 clinical trials, the observed rates of fever (≥39.4°C rectal equivalent) ranged from 10.1% to 39.4%.
Maltese: Wara li ProQuad ingħata waħdu f'7 provi kliniċi, ir-rati ta' deni osservati (ekwivalenti għal ≥39.4°C fir-rektum) varjaw minn 10.
English: The safety profiles were comparable for the two different formulations after a single dose.
Maltese: Il-profili ta' sigurtà ta' dawn iż-żewġ formolazzjonijiet differenti kienu komparabbli wara doża waħda.
English: 1 Enders' Edmonston strain (live, attenuated)........ not less than 3.00 log10 CCID50*
Maltese: Virus tal-ħosba1 razza Enders' Edmonston, (ħaj, attenwat) ..................mhux inqas minn 3.00 log10
English: Complications of varicella from vaccine strain including herpes zoster and disseminated disesase such as aseptic meningitis and encephalitis have been reported in immunocompromised or immunocompetent individuals.
Maltese: Ġew irrappurtati komplikazzjonijiet ta' varicella minn razza tal-vaċċin li jinkludu erpete zoster u mard imxerred bħal meningite asettika u enċefalite f'persuni immunokompromessi jew immunokompetenti.
English: 10 vials (powder) + 10 pre-filled syringes (solvent)+ 20 needles.
Maltese: 10 kunjetti (trab) + 10 siringi mimlijin għal-lest (solvent) + 20 labra.
English: ProQuad is not contraindicated in individuals who are receiving topical or low-dose parenteral corticosteroids (e.g. for asthma prophylaxis or replacement therapy).
Maltese: ProQuad mhuwiex kontraindikat f'individwi li qed jieħdu kortikosterojdi topiċi jew dożi baxxi ta' kortikosterojdi parenterali (eżempju għall-prevenzjoni tal-ażma jew bħala terapija ta' sostituzzjoni).
English: 3 Oka/Merck strain (live, attenuated) ................... not less than 3.99 log10 PFU**
Maltese: Virus tal-ġidri r-riħ1, razza Oka/Merck (ħaj, attenwat) ..........................mhux inqas minn 3.99 PFU
English: Encephalitis and encephalopathy
Maltese: Enċefalite u enċefalopatija
English: ProQuad is a vaccine containing measles, mumps, rubella, and varicella (chickenpox) viruses that have been weakened.
Maltese: ProQuad huwa vaċċin li fih il-virus tal-ħosba, tal-gattone, tar-rubella, u tal-ġidri r-riħ (chickenpox) li ġew imdgħajfa.
English: Following the dose of ProQuad, GMTs for measles, mumps, rubella, and varicella were similar to those following a second dose of Varicella Vaccine live (Oka/Merck) and the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc. administered concomitantly at separate injection sites.
Maltese: Wara d-doża ta' ProQuad, GMTs għall-ħosba, gattone, rubella, u ġidri r-riħ kienu simili għal dawk wara tieni doża ta' Varicella Vaccine live (Oka/Merck) u tal-vaċċin tal-ħosba, gattone, u rubella mmanifatturat minn Merck & Co., Inc. mogħti fl-istess ħin f'postijiet t'injezzjoni separati.
English: In combined clinical trials of a single dose of Varicella Vaccine live (Oka/Merck) in healthy children, the protective efficacy of the vaccine against all severities of varicella disease ranged from 81% to 100%.
Maltese: Fi provi kliniċi kkombinati ta' doża waħda ta' Varicella Vaccine live (Oka/Merck) fi tfal b'saħħithom, l-effikaċja tal-protezzjoni tal-vaċċin kontra s-severitajiet kollha tal-marda tal- ġidri r-riħ kellha medda ta' bejn 81 % u 100 %.
English: In a clinical trial of ProQuad administered concomitantly with Infanrix Hexa, the rates of fever (≥38.0°C rectal equivalent) were 69.3% following concomitant administration, 61.1% following ProQuad alone, and 57.3% following Infanrix Hexa alone; the rates of fever (≥39.4°C rectal equivalent) were 22.6% following concomitant administration, 20.5% following ProQuad alone, and 15.9% following Infanrix Hexa alone.
Maltese: Fi prova klinika fejn ProQuad ingħata flimkien ma' Infanrix Hexa, ir-rati ta' deni (ekwivalenti għal ≥38.0°C fir-rektum) kienu ta' 69.3% wara l-għoti tagħhom it-tnejn flimkien, 61.1% wara l-għoti ta' ProQuad waħdu, u 57.3% wara l-għoti ta' Infanrix Hexa waħdu; ir-rati ta' deni (ekwivalenti għal
English: Antibody responses against varicella virus ≥5 gpELISA Units/ml in the glycoprotein enzyme-linked immunosorbent assay (gpELISA, a highly sensitive assay which is not commercially available) have been shown to be highly correlated with long-term protection.
Maltese: Ir-risponsi ta' antikorpi kontra l-virus tal-ġidri r-riħ ≥ 5 gpELISA Units/ml fl-assaġġ immunosorbenti tal-glikoproteina f'għaqda mal-enzimi (gpELISA, assaġġ sensittiv ferm li mhuwiex disponibbli fissuq) intwerew li kienu korrelatati ferm ma' protezzjoni fit-tul.
English: The general safety profiles of the IM and SC administration routes were comparable; however, fewer subjects experienced injection-site adverse reactions in the IM group after each dose (see section 5.1 for study description).
Maltese: Il-profili ġenerali tas-sigurtà ta' għoti mir-rotot IM u SC kienu komparabbli; madankollu, inqas individwi kellhom reazzjonijiet avversi fis-sit tal-injezzjoni fil-grupp IM wara kull doża (ara sezzjoni 5.1 għad-deskrizzjoni tal-istudju).
English: In 2 clinical trials, 1035 subjects were administered a second dose of ProQuad approximately 3 months after the first dose.
Maltese: F'2 provi kliniċi, 1035 suġġett ġew mogħtija tieni doża ta' ProQuad bejn wieħed u ieħor 3 xhur wara lewwel doża.
English: Evaluation of immunogenicity in children from 9 to 12 months of age at the time of first dose A clinical study was conducted with ProQuad administered with a 2-dose schedule, the doses being given 3 months apart in 1,620 healthy subjects from 9 to 12 months of age at the time of first dose.
Maltese: Stima tal-immunoġeniċità fit-tfal b'età minn 9 xhur sa 12-il xahar meta ħadu l-ewwel doża Sar studju kliniku bi ProQuad li ngħata bi skeda ta' 2 dożi, id-dożi ngħataw 3 xhur 'il bogħod minn xulxin lil 1,620 individwu f'saħħtu li kellhom minn 9 xhur sa 12-il xahar meta ħadu l-ewwel doża.
English: Blood and the lymphatic system disorders Leukocytosis, Lymphadenopathy
Maltese: Disturbi tad-demm u tas-sistema limfatika Lewkoċitosi, Limfadenopatija
English: The presence of detectable antibody was assessed by an appropriately sensitive enzyme-linked immunosorbent assay (ELISA) for measles, mumps (wild-type and vaccine-type strains), and rubella, and by gpELISA for varicella.
Maltese: Il-preżenza ta' antikorpi li jistgħu jiġu osservati ġiet stmata b'assaġġ immunosorbenti ta' għaqda ma l-enzimi (ELISA) sensittiv kif meħtieġ għall-ħosba, gattone (tipi salvaġġ u tal-vaċċin), u rubella, u b'gpELISA għall-ġidri r-riħ.
English: Abdominal pain, Haematochezia, Mouth ulcer
Maltese: Uġigħ fl-addome, Ematokiżja, Ulċera fil-ħalq
English: EU/1/05/323/003 - pack of 1 EU/1/05/323/004 - pack of 10
Maltese: EU/1/05/323/004 - pakkett ta' 10
English: • Rare (may affect up to 1 in 1,000 people): bronchiolitis (difficulty breathing with or without cough); unsteadiness with walking.
Maltese: • Rari (jistgħu jaffettwaw sa persuna 1 minn kull 1,000): bronkijolite (diffikultà biex tieħu n-nifs bis-sogħla jew mingħajrha); ma tkunx sod fil-mixi.
English: In the 5- to 12-day timeframe after the administration of the first dose of quadrivalent measles, mumps, rubella and varicella vaccines in children, an increased risk of febrile seizure was observed compared to concomitant administration of measles, mumps, rubella and varicella vaccines (see sections 4.8 and 5.1).
Maltese: Fil-perijodu ta' 5 ijiem sa 12-il jum wara l-għoti tal-ewwel doża tat-tilqim kwadrivalenti kontra lħosba, il-gattone, il-ħosba Ġermaniża u l-ġidri r-riħ fit-tfal, kienet osservata żieda fir-riskju ta' aċċessjonijiet tad-deni meta mqabbla mal-għoti flimkien ta' tilqim kontra l-ħosba, il-gattone, il-ħosba Ġermaniża u l-ġidri r-riħ (ara sezzjonijiet 4.8 u 5.1).
English: If you forget to take ProQuad
Maltese: Tfal li ħadu t-tieni doża ta' ProQuad
English: Dermatitis (including contact, atopic, and diaper rash), Heat rash, Rubella-like rash
Maltese: Dermatite (inklużi dawk ta' kuntatt, atopiċi u raxx tal-ħrieqi), Raxx tassħana, Raxx bħal tal-ħosba Ġermaniża‡, Urtikarja, Eksantema minn virus, Ekżema, Ħmura
English: Patients with rare hereditary problems of fructose intolerance should not take this vaccine.
Maltese: Pazjenti bi problemi ereditarji rari ta' intolleranza għall-fructose ma jistgħux jieħdu dan il-vaċċin.
English: However, in-use stability has been demonstrated for 30 minutes when stored between 20C and 25C.
Maltese: Wara r-rikostituzzjoni, uża minnufih jew fi żmien 30 minuta jekk maħżun f'temperatura bejn 20°C u 25°C.
English: However, the efficacy of Varicella Vaccine live (Oka/Merck) and the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc. has been demonstrated in numerous studies.
Maltese: Madankollu, l-effikaċja ta' Varicella Vaccine live (Oka/Merck) u tal-vaċċin tal-ħosba, gattone, u tar-rubella mmanifatturati minn Merck & Co., Inc. ġiet murija b'bosta studji.
English: Additionally, GMTs for measles, mumps, and rubella were similar to those following a second dose of the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc. given concomitantly with placebo (for safety information, see section 4.8).
Maltese: Barra minn hekk, GMTs għall-ħosba, gattone, u rubella kienu simili għal dawk wara tieni doża tal-vaċċin talħosba, gattone, u rubella mmanifatturat minn Merck & Co., Inc. mogħti fl-istess ħin ma' plaċebo (għal informazzjoni dwar is-sigurtà, ara sezzjoni 4.8).
English: ProQuad powder for suspension for injection
Maltese: Trab u solvent għal suspensjoni għall-injezzjoni
English: Powder in a vial (glass) with a stopper (butyl rubber) and solvent in a pre-filled syringe (glass) with plunger stopper (chlorobutyl rubber) and tip cap (styrene-butadiene rubber), without needle, in a pack size of 1, 10 and 20.
Maltese: Trab f'kunjett (ħġieġ) b'tapp (lastku butyl) u solvent f'siringa mimlija għal-lest (ħġieġ) b'tapp talplanġer (lastku chlorobutyl) u għatu tat-tarf (lastku styrene-butadiene), mingħajr labra, f'pakkett b'daqs ta' 1, 10, u 20.
English: There are no reports of transmission of the more attenuated Enders' Edmonston strain of measles virus or the Jeryl Lynn™ strain of mumps virus from vaccine recipients to susceptible contacts.
Maltese: M'hemmx rapporti ta' trasmissjoni tal-virus tal-ħosba tar-razza Enders' Edmonston li huwa aktar attenwat jew tal-virus tal-gattone tar-razza Jeryl Lynn™ mir-riċevituri tal-vaċċin għal kuntatti suxxettibbli.
English: ProQuad - Powder in vial and solvent in pre-filled syringe with attached needle - Pack of 1, 10
Maltese: Trab f'kunjett (ħġieġ) b'tapp (lastku butyl) u solvent f'kunjett (ħġieġ) b'tapp (lastku chlorobutyl) f'pakkett ta' daqs 1 u 10.
English: Administration of immune globulins concomitantly with ProQuad may interfere with the expected immune response.
Maltese: Għoti ta' immuno globulini fl-istess ħin ta' ProQuad jista' jinterferixxi mar-rispons ta' l-immunità mistenni.
English: Luxembourg/Luxemburg MSD Belgium BVBA/SPRL Tél/Tel: +32(0)27766211 dpoc_belux@merck.com
Maltese: +32(0)27766211) dpoc_belux@merck.com
English: While the seroconversion rate for varicella was uniformly high (97.9% to 99.8% across all studies), seroconversion has not been shown to correlate well with protection.
Maltese: Filwaqt li r-rata ta' serokonverżjoni għall-ġidri r-riħ kienet għolja b'mod uniformi (97.9% għal 99.8% tul l-istudji kollha), is-serokonverżjoni ma ntweritex li tikkorrelata tajjeb mal-protezzjoni.
English: Additionally, other adverse events have been reported with postmarketing use of ProQuad and/or in clinical studies and post-marketing use of either the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc., the monovalent component vaccines of the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc., or Varicella Vaccine live (Oka/Merck).
Maltese: Barra minn hekk, ġew irrapportati avvenimenti avversi oħrajn ma' l-użu wara t-tqegħid fis-suq ta' ProQuad u/jew fi studji kliniċi u użu wara t-tqegħid fis-suq tat-tilqima talħosba, gattone u rubella ffabbrikata minn Merck & Co., Inc., jew il-Vaċċin tal-Variċella ħaj (Oka/Merck).
English: EU/1/05/323/001 - pack of 1 EU/1/05/323/002 - pack of 10
Maltese: EU/1/05/323/002 - pakkett ta' 10
English: Inject the entire content of the solvent syringe into the vial containing the powder.
Maltese: Iġbed il-kontenut kollu tal-kunjett tas-solvent f'siringa.
English: The following other side effects reported with the use of ProQuad were:
Maltese: L-effetti sekondarji oħra li ġejjin irrapportati bl-użu ta' ProQuad kienu:
English: ProQuad powder and solvent for suspension for injection Measles, mumps, rubella and varicella vaccine (live)
Maltese: ProQuad Trab u solvent għal suspensjoni għall-injezzjoni Vaċċin (ħaj) tal-ħosba, gattone, rubella u ġidri r-riħ
English: ProQuad can be given at the same time as other childhood vaccines such as Prevenar, and/or hepatitis A vaccine, or with vaccines containing diphtheria, tetanus, acellular pertussis, Haemophilus influenzae type b, inactivated poliomyelitis, or hepatitis B. A different place for the injection will be used for each vaccine.
Maltese: ProQuad jista' jingħata fl-istess ħin ma' tilqim ieħor li jingħata fit-tfulija bħal Prevenar, u/jew ilvaċċin tal-epatite A, jew ma' tilqim li fih id-difterite, it-tetnu, il-pertussis aċellulari, il-Haemophilus influenzae tat-tip b, il-poljomelite inattivata, jew l-epatite B.
English: • If the person to be vaccinated has a weakened immune system because of a disease (including AIDS).
Maltese: • Jekk il-persuna li se titlaqqam għandha sistema ta' immunità mdgħajfa minħabba marda (inkluż AIDS).
English: Tel: +386.1.520.4201 msd.slovenia@merck.com
Maltese: Tel: +421.2.58282010 dpoc_czechslovak@merck.com
English: In a second long-term surveillance study, five cross-sectional surveys on varicella incidence, each from a random sample of approximately 8,000 children and adolescents 5 to 19 years of age, were conducted over 15 years, from 1995 (pre-vaccine) through 2009.
Maltese: Fi studju ieħor ta' sorveljanza fit-tul, ħames stħarriġ cross sectional dwar l-inċidenza tal-ġidri r-riħ, kull wieħed minn kampjun każwali ta' madwar 8,000 tifel u tifla u adolexxenti b'età minn 5 snin sa 19-il sena, twettqu fuq perjodu ta' 15-il sena, mill-1995 (qabel ma kien disponibbli t-tilqim) sal-2009.
English: Ataxia, Convulsion, Headache, High-pitched crying, Hyperkinesia, Hypersomnia, Lethargy, Tremor
Maltese: Atassja, Konvulżjoni, Uġigħ ta' ras, Biki b'tonalità għolja, Iperkinesja, Rqad esaġerat, Letarġija, Rogħda
English: • A side effect after vaccination with measles, mumps, or rubella (in a single vaccine or combined vaccine, such as the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc. or ProQuad) that involved easy bruising or bleeding for longer than usual.
Maltese: • Effett sekondarju wara t-tilqima bil-ħosba, gattone, jew rubella (f'tilqima singola jew f'tilqima kombinata, bħat-tilqima tal-ħosba, gattone, u rubella mmanifatturata minn Merck & Co., Inc. jew ProQuad) li kien jinvolvi tbenġil malajr jew fsad itwal min-normal.
English: The risk-to-benefit ratio should be carefully evaluated before considering vaccination with ProQuad in such cases (see section 4.8).
Maltese: Il-proporzjon ta' riskju u benefiċċju għandu jiġi stmat b'attenzjoni qabel wieħed jikkunsidra tilqim f'każijiet bħal dawn (ara sezzjoni 4.8).
English: Infections and infestations Upper respiratory infection
Maltese: Prevenzjoni wara espożizzjoni għall-virus
English: ProQuad with Solvent for reconstitution supplied in a Pre-filled syringe: Powder in a vial (glass) with a stopper (butyl rubber) and solvent in a pre-filled syringe (glass) with attached needle with plunger stopper (chlorobutyl rubber) and needle shield (natural rubber) in a pack size of 1 and 10.
Maltese: Trab f'kunjett (ħġieġ) b'tapp (lastku butyl) u solvent f'siringa mimlija għal-lest (ħġieġ) b'labra mwaħħla b'tapp tal-planġer (lastku chlorobutyl) u bi protezzjoni għal-labra (lastku naturali) f'pakkett b'daqs ta' 1 u 10.
English: These results were similar to the immune response rates induced by concomitant administration of a single dose of Varicella Vaccine live (Oka/Merck) and the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc. at separate injection sites.
Maltese: Dawn ir-riżultati kienu simili għar-rati ta' risposta ta' l-immunità indotti b'għoti fl-istess ħin ta' doża waħda ta' Varicella Vaccine live (Oka/Merck) u l-vaċċin tal-ħosba, gattone, u rubella mmanifatturat minn Merck & Co., Inc.
English: ProQuad is given to help protect your child against measles, mumps, rubella, and varicella (chickenpox).
Maltese: ProQuad jingħata sabiex jgħin lit-tifel/tifla tiegħek fil-protezzjoni kontra l-ħosba, gattone, rubella, u ġidri r-riħ (chickenpox).
English: In severely immunocompromised individuals inadvertently vaccinated with measles-containing vaccine, measles inclusion body encephalitis, pneumonitis, and fatal outcome as a direct consequence of disseminated measles vaccine virus infection have been reported.
Maltese: F'individwi li kienu severament immunokompromessi u li mingħajr ma jafu ġew injettati bil-vaċċin li fih il-virus tal-ħosba, ġie rrappurtat li kien hemm enċefalite b'inclusion body tal-ħosba, pulmonite u riżultati fatali, konsegwenza diretta ta' tixrid tal-infezzjoni bil-virus tal-vaċċin tal-ħosba.
English: Thrombocytopenia
Maltese: TAS-SUSTANZI BIJOLOĠIĊI ATTIVI
English: ‡, Erythema
Maltese: OĦRAJN
English: No clinical data are available for ProQuad administered after exposure to measles, mumps, rubella, or varicella.
Maltese: Każijiet ta' meninġite asettika ġew irrapportati wara t-tilqima ta' kontra l-ħosba, gattone u rubella.
English: History of hypersensitivity to any varicella vaccine or measles, mumps, or rubella vaccine, to any of the excipients, or to neomycin, which may be present as trace residues (see sections 2, 4.4 and 6.1).
Maltese: Storja ta' sensittività eċċessiva għal xi vaċċin tal-ġidri r-riħ jew għall-vaċċin tal-ħosba, gattone jew rubella, jew għal kwalunkwe wieћed mill-eċċipjenti, jew għall-neomycin, li jistgħu jkunu preżenti bħala traċċi residwi (ara sezzjonijiet 2, 4.4 u 6.1).
English: Dose 1 at 11 months / Dose 2 at 14 months N = 480
Maltese: 11-il xahar/ It-tieni doża ta' 14-il xahar
English: Ref. EMEA/121008/2008
Maltese: EMEA/186556/2008
English: 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 86 68 E-mail: mail@emea.europa.eu http://www.emea.europa.eu
Maltese: (44-20) 74 18 84 00 Fax (44-20) 74 18 86 68 E-mail: mail@emea.europa.eu http://www.emea.europa.eu
English: International non-proprietary name (INN): miglustat
Maltese: Denominazzjoni Komuni Internazzjonali (DKI): miglustat
English: Information was available from 23 patients.
Maltese: Kien hemm informazzjoni disponibbli dwar 23 pazjent.
English: Zavesca is a hard white capsule, which contains the active substance miglustat.
Maltese: Zavesca hija kapsula bajda iebsa, li fiha s-sustanza attiva miglustat.
English: Miglustat, the active substance in Zavesca, prevents an enzyme called ‘glucosylceramide synthase' from working.
Maltese: Miglustat, is-sustanza attiva f'Zavesca, jipprevjeni enzim magħruf bħala sintażi tal-glukosilċeramide (glucosylceramide synthase) milli jaħdem.
English: Symptoms include a progressive loss of co-ordination, problems with ‘saccadic' (rapid) eye movements that can lead to impaired vision, delayed development, difficulty swallowing, increased muscle tone, fits, and learning difficulties.
Maltese: Is-sintomi jinkludu tnaqqis progressiv fil-koordinazzjoni, problemi biċ-ċaċliq ‘sakkadiku' (rapidu) ta' l-għajn li jista' jwassal għal problemi bil-vista, ritardar fl-iżvilupp, tbatija biex wieħed jibla', żieda fit-ton tal-muskoli, aċċessjonijiet, u diffikultajiet fit-tagħlim.
English: The medicine was also studied in 12 patients aged less than 12 years.
Maltese: Ilmediċina ġiet studjata wkoll fi 12-il pazjent ta' inqas minn 12-il sena.
English: On 19 February 2008, Actelion Registration Ltd. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a new indication for Zavesca, in the treatment of neurological manifestations in patients with Niemann Pick type C disease.
Maltese: Fid-19 ta' Frar 2008, Actelion Registration Ltd. għarrfet uffiċjalment lill-Kumitat għall-Prodotti Mediċinali għal Użu mill-Bniedem (CHMP) bl-intenzjoni tagħha li tirtira l-applikazzjoni għal indikazzjoni ġdida għal Zavesca, fit-trattament ta' manifestazzjonijiet newroloġiċi f'pazjenti bil-marda ta' Niemann Pick tat-tip C.
English: The study compared the effects of adding Zavesca taken at a dose of 200 mg three times a day to standard care with the effects of standard care alone.
Maltese: f'doża ta' 200 mg tliet darbiet kuljum mal-kura standard ma' l-effetti tal-kura standard weħidha.
English: Zavesca was designated as an orphan medicinal product on 16 February 2006 for Niemann Pick type C disease.
Maltese: Zavesca ġiet deżinjata bħala ‘mediċina orfni' (mediċina li tintuża f'mard rari) għall-marda Niemann Pick tat-tip C fis-16 ta' Frar 2006.
English: In the new indication, Zavesca was expected to be used to treat the ‘neurological' symptoms of Niemann Pick type C disease (affecting the brain and nervous system).
Maltese: Fl-indikazjoni l-ġdida, Zavesca kienet mistennija li tintuża fit-trattament tas-sintomi ‘newroloġiċi' talmarda Niemann Pick tat-tip C (li taffettwa l-moħħ u s-sistema nervuża).
English: The medicine showed a very limited benefit in the main study: there was only a marginal difference in the change in the speed of eye movements between the patients taking Zavesca and those receiving standard care, and there were uncertainties over whether looking at eye movements was the best way to measure the medicine's effectiveness.
Maltese: Il-mediċina wriet benefiċċju limitat ħafna fl-istudju ewlieni: kien hemm biss differenza marġinali fit-tibdil fil-ħeffa taċ-ċaqliq ta' lgħajn bejn pazjenti li kienu qed jieħdu Zavesca u dawk li kienu qed jingħataw kura standard, u kien hemm inċertezzi fuq jekk l-analiżi taċ-ċaqliq ta' l-għajn kienx l-aqwa mod għall-kejl ta' l-effikaċja talmediċina.