FrancophonIA/ELRC3.0 huggingface dataset:
English: In both studies, 6.5 mg Intrarosa was given once a day for 12 weeks.
Maltese: Fiż-żewġ studji, Intrarosa 6.5 mg ingħata darba kuljum għal 12-il ġimgħa.
English: EPAR summary for the public
Maltese: Sommarju tal-EPAR għall-pubbliku prasterone
English: The active substance of Intrarosa, prasterone, is converted into the sex hormones oestrogens and androgens when inserted into the vagina.
Maltese: Is-sustanza attiva ta' Intrarosa, il-prasterone, tinbidel fl-ormoni sesswali tal-estroġeni u l-androġeni meta tiddaħħal fil-vaġina.
English: Results showed that the number of superficial cells (which normally falls with atrophy) increased by 6% and 10% with Intrarosa compared with about 1% and 2% with placebo.
Maltese: Ir-riżultati wrew li n-numru ta' ċelloli superfiċjali (li normalment jitbaxxa bl-atrofija) żdied b'6 % u 10 % b'Intrarosa meta mqabbel ma' madwar 1 % u 2 % bil-plaċebo.
English: In addition, Intrarosa treatment was better at increasing acidity in the vagina (which normally becomes less acidic with atrophy), with pH values reducing by 0.9 and 1.0 with Intrarosa and by 0.2 and 0.3 with placebo.
Maltese: Barra minn hekk, il-kura b'Intrarosa kienet aħjar biex iżżid l-aċidità fil-vaġina (li normalment issir inqas aċidika bl-atrofija), bil-valuri pH li tnaqqsu b'0.9 u 1.0 b'Intrarosa u b'0.2 u 0.3 bil-plaċebo.
English: Two studies involving 813 post-menopausal women with vulvar and vaginal atrophy found that treatment with Intrarosa was more effective than placebo (a dummy treatment) at reducing signs of thinning (atrophy) of vaginal tissues.
Maltese: Żewġ studji li involvew 813-il mara ta' wara l-menopawża b'atrofija vulvari u vaġinali sabu li l-kura b'Intrarosa kienet aktar effettiva mill-plaċebo (kura finta) biex tnaqqas is-sinjali ta' rquqija (atrofija) tat-tessut vaġinali.
English: Intrarosa prasterone
Maltese: Kif jintuża Intrarosa?
English: In women with vulvar and vaginal atrophy, the wall of the vagina and surrounding tissues become thinner and can cause symptoms such as dryness, irritation and soreness around the genital area, and painful sexual intercourse.
Maltese: F'nisa b'atrofija vulvari u vaġinali, il-ħajt tal-vaġina u t-tessut tal-madwar jirqaq u jista' jikkawża sintomi bħal nixfa, irritazzjoni u uġigħ madwar il-parti ġenitali, u sess b'uġigħ.
English: For the full list of side effects reported with Intrarosa, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji rrappurtati b'Intrarosa, ara l-fuljett ta' tagħrif.
English: Pain during sexual intercourse was self-assessed by patients using a standard scale ranging from 0 (no pain) to 3 (severe pain).
Maltese: L-uġigħ waqt is-sess ġie vvalutat mill-pazjenti stess bl-użu ta' skala standard li tvarja minn 0 (l-ebda uġigħ) sa 3 (uġigħ sever).
English: Intrarosa is a medicine used to treat postmenopausal women with moderate to severe symptoms of vulvar and vaginal atrophy.
Maltese: Intrarosa huwa mediċina li jintuża biex jikkura nisa ta' wara l-menopawża b'sintomi moderati sa severi ta' atrofija vulvari u vaġinali.
English: The company that markets Intrarosa is required to conduct a study on how the medicine is used in clinical practice, including whether it is used according to the authorised product information.
Maltese: Il-kumpanija li tqiegħed Intrarosa fis-suq hija meħtieġa li twettaq studju dwar kif il-mediċina tintuża fil-prassi klinika, inkluż jekk tintużax skont l-informazzjoni dwar il-prodott awtorizzata.
English: Strength Pharmaceutical Form Route of Administration
Maltese: 24 kunjett + 24 siringa mimlija għal-lest + 24 labra + 24 adapter għal kunjetti + 48 swab
English: Content (concentration)
Maltese: 1 ml (50 mg/ml) 12-il siringa mimlija għal-lest + 12-il swab
English: MA (EU) number
Maltese: 1 ml (50 mg/ml) 12-il pinna mimlija għal-lest + 12-il swab
English: Pack size
Maltese: 24 siringa mimlija għal-lest + 24 swab
English: The full EPAR for Oxybee can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: The dispersion should be warmed to 30-35˚C before application.
Maltese: Id-dispersjoni għandha tissaħħan għal 30-35˚C qabel tiġi applikata.
English: The effectiveness of Oxybee to kill mites was 97% and 95% in these studies.
Maltese: F'dawn l-istudji, l-effikaċja ta' Oxybee biex joqtol id-dud kien 97 % u 95 %.
English: Other information about Oxybee
Maltese: Informazzjoni oħra dwar Oxybee
English: Oxybee oxalic acid
Maltese: Oxybee aċidu ossaliku
English: This is a summary of the European public assessment report (EPAR) for Oxybee.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Oxybee.
English: Oxybee contains the active substance oxalic acid.
Maltese: Oxybee fih is-sustanza attiva aċidu ossaliku.
English: The effectiveness of Oxybee against varroa mites was investigated in two field studies in European countries with different climates.
Maltese: L-effikaċja ta' Oxybee kontra l-varro mites ġiet investigata f'żewġ studji fuq il-post fil-pajjiżi Ewropej bi klimi differenti.
English: Varroosis is a disease of honey bees caused by infestation with a parasite called varroa mite (Varroa destructor).
Maltese: Varroażi hija marda tan-naħal tal-għasel ikkawżata minn infestazzjoni b'parassita bl-isem ta' varroa mite (Varroa destructor).
English: Oxybee is trickled onto bees in the hive and should only be used when the temperature outside the hives is at least 3˚C.
Maltese: Oxybee jitqattar fuq in-naħal fid-doqqajs u għandu jintuża biss meta t-temperatura barra d-doqqajs tkun mill-inqas 3˚C.
English: The varroa mite feeds on the haemolymph (blood) of adult bees and on brood (developing stages of the honey bee) resulting in harm and/or death of bees; the mite can also help spread viruses and bacteria.
Maltese: Il-varroa mite tiekol mill-emolimf (demm) tan-naħal adult u tad-duqqajs (l-istadji tal-iżvilupp tan-naħla tal-għasel) li jirriżulta fil-ħsara u/jew fil-mewt tan-naħal; id-dud jista' jgħin ukoll biex iferrex il-virusis u l-batterji.
English: Why is Oxybee approved?
Maltese: Għaliex ġie approvat Oxybee?
English: What are the risks associated with Oxybee?
Maltese: X'inhuma r-riskji assoċjati ma' Oxybee?
English: Oxybee is a medicine used to treat varroosis in honey bee colonies.
Maltese: Oxybee huwa mediċina li tintuża għall-kura ta' varroażi f'kolonji tan-naħal tal-għasel.
English: This did not affect long-term development of colonies.
Maltese: Dan m'affettwax l-iżvilupp fit-tul tal-kolonji.
English: Oxybee is highly acidic and could be irritating or corrosive to the skin, eyes and mucous membranes (inner lining of body cavities like the mouth or nose).
Maltese: Oxybee huwa aċiduż ħafna u jista' jkun irritanti jew korrużiv għall-ġilda, l-għajnejn u l-membrani mukużi (is-saff ta' ġewwa tal-kavitajiet tal-ġisem bħall-ħalq u l-imnieħer).
English: Oxybee can only be used on colonies without brood.
Maltese: Oxybee jista' jintuża biss f'kolonji mingħajr duqqajs.
English: Protective clothing, acid resistant gloves and safety glasses should be worn during treatment.
Maltese: L-ilbies protettiv, l-ingwanti reżistenti għall-aċidu u n-nuċċalijiet tas-sigurtà għandhom jintlibsu waqt il-kura.
English: In the first study treatment with Oxybee was compared to another oxalic acid medicine and to a group with no treatment whilst in the second study treatment with Oxybee was compared to a group with no treatment.
Maltese: Fl-ewwel studju, il-kura b'Oxybee tqabblet ma' mediċina ta' aċidu ossaliku oħra u ma' grupp bl-ebda kura filwaqt li fit-tieni studju, il-kura b'Oxybee tqabblet ma' grupp mingħajr kura.
English: The most common side effect with Oxybee (which may affect more than 1 in 10 bee colonies) is an increased number of bee deaths.
Maltese: L-effett sekondarju l-aktar komuni b'Oxybee (li jista' jaffettwa aktar minn kolonja tan-naħal 1 minn kull 10) hu għadd akbar ta' mwiet tan-naħal.
English: The withdrawal period is the time required after administration of a medicine before honey may be used for human consumption.
Maltese: In-nies ma għandhomx jieklu, jixorbu jew ipejpu waqt li jkunu qed jużaw il-mediċina.
English: Oxybee is available as a powder and solution to prepare a bee-hive dispersion (a liquid for use inside the bee hive) and can be obtained without a prescription.
Maltese: Oxybee jiġi bħala trab u soluzzjoni għat-tħejjija ta' dispersjoni tad-doqqajs (likwidu biex jintuża fid-doqqajs) u jista' jinkiseb mingħajr riċetta tat-tabib.
English: How oxalic acid works on mites is not well understood but is thought to be due to the acidity of the medicine, which kills the mites on contact.
Maltese: Il-mod kif l-aċidu ossaliku jaħdem fuq id-dud mhux mifhum sew iżda huwa maħsub li dan jiġi kkawżat minħabba l-aċidità tal-mediċina, li toqtol id-dud mal-kuntatt.
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Oxybee's benefits are greater than its risks and recommended that it be approved for use in the EU.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu Veterinarju (CVMP) tal-Aġenzija ddeċieda li l-benefiċċji ta' Oxybee huma akbar mir-riskji tiegħu u rrakkomanda li jkun approvat għall-użu fl-UE.
English: How does Oxybee work?
Maltese: X'inhu Oxybee u għal xiex jintuża?
English: March 2025
Maltese: Marzu 2025
English: CL, ml/minute/kg‡ t1/2, minute§
Maltese: CL, ml/minuta/kg‡ t1/2, minuta§
English: Vimizim vs. placebo
Maltese: Vimizim vs. plaċebo
English: The active substance is elosulfase alfa.
Maltese: Is-sustanza attiva hi elosulfase alfa.
English: ATC code: A16AB12.
Maltese: A16AB12.
English: BioMarin Pharmaceutical, Inc. Galli Drive Facility 46 Galli Drive
Maltese: Galli Drive Facility 46 Galli Drive
English: MedDRA System organ class
Maltese: MedDRA Sistema tal-klassifika tal-organi
English: Total infusion volume (ml)
Maltese: Volum ta' infużjoni totali (ml)
English: Mean half-life (t1/2) increased from 7.52 minutes at Week 0 to 35.9 minutes at Week 22.
Maltese: Il-half-life medju (t1/2) żdied minn 7.52 minuta f'Ġimgħa 0 sa 35.9 minuti sa Ġimgħa 22.
English: Submission of final study report:
Maltese: Sottomissjoni tar-rapport ta' studju finali:
English: Table 1: Recommended infusion volumes and rates*
Maltese: Tabella 1: Volumi u rati ta' infużjoni rakkomandati*
English: Each 5 ml vial contains 8 mg sodium and 100 mg sorbitol (E420).
Maltese: Kull kunjett ta' 5 ml fih 8 mg sodium u 100 mg sorbitol (E420).
English: Pack sizes: 1 vial
Maltese: Daqsijiet tal-pakkett: 1 kunjett.
English: At Week 22, the mean AUC0-t and Cmax increased by 181% and 192%, respectively, when compared to Week 0
Maltese: F'ġimgħa 22, l-AUC0-t u Cmax medji żdiedu b'181% u 192%, rispettivament, meta mqabbla ma' Ġimgħa 0.
English: Model-based mean‡ (95%CI) p-value
Maltese: (95%CI) valur p
English: BioMarin International Limited Shanbally, Ringaskiddy, Co. Cork Ireland
Maltese: BioMarin International Limited Shanbally, Ringaskiddy, Co. Cork L-Irlanda
English: Week 0 Mean (SD)
Maltese: Ġimgħa 0 Medja (SD)
English: Step 1 Initial infusion rate 0-15 minutes (ml/hr)
Maltese: Pass 1 Rata ta' infużjoni inizjali 015-il minuta (ml/hr)
English: Week 22 Mean (SD)
Maltese: Ġimgħa 22 Medja (SD)
English: • Patient weight (kg) multiplied by 2 (mg/kg) = Patient dose (mg)
Maltese: • Piż tal-pazjent (kg) immultiplikat bi 2 (mg/kg) = doża tal-pazjent (mg)
English: Currently available data are described in section 4.8 and section 5.1.
Maltese: Dejta disponibbli hi deskritta fissezzjoni 4.8 u sezzjoni 5.1
English: No differences in the safety profile were observed.
Maltese: Ma ġiet osservata ebda differenza fil-profil tas-sigurtà.
English: For management of adverse reactions, see sections 4.4 and 4.8.
Maltese: .Għall-ġestjoni tar-reazzjonijiet avversi, ara sezzjonijiet 4.4 u 4.8.
English: Preparation of the Vimizim infusion (Use aseptic technique)
Maltese: Preparazzjoni tal-infużjoni ta' Vimizim (Uża teknika asettika)
English: The other ingredients are: sodium acetate trihydrate, sodium dihydrogen phosphate monohydrate, arginine hydrochloride, sorbitol, polysorbate 20, and water for injections (see section 2 under ‘Vimizim contains sodium and sorbitol (E420)').
Maltese: Is-sustanzi l-oħra huma: sodium acetate trihydrate, sodium dihydrogen phosphate, arginine hydrochloride, sorbitol, polysorbate 20, u ilma għall-injezzjonijiet (ara sezzjoni 2 taħt ‘Vimizim fih sodium u sorbitol (E420)').
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) and not known (cannot be estimated from available data).
Maltese: Il-frekwenzi huma mfissra 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); mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: This is equivalent to 0.4 % of the recommended daily dietary intake of sodium for an adult.
Maltese: Dan huwa ekwivalenti għal 0.4% tal-konsum irrakkomandat fid-dieta ta' kuljum ta' sodium għal adult.
English: N 58 6-Minute walk test (meters) Mean SD
Maltese: Test tal-mixi f'6 minuti (metri) Medja ± SD
English: Vimizim contains sodium and sorbitol (E 420)
Maltese: Vimizim fih sodium u sorbitol (E420)
English: Pharmacotherapeutic group: Other alimentary tract and metabolism products, enzymes.
Maltese: Prodotti tal-passaġġ alimentari u tal-metaboliżmu oħrajn, enzimi.
English: Table 4: Pharmacokinetic properties
Maltese: Tabella 4: Tagħrif farmakokinetiku
English: Pack sizes: 1 vial of 5 ml
Maltese: Daqsijiet tal-pakkett: 1 kunjett ta' 5 ml.
English: Tmax, minute¶ * AUC0-t, area under the plasma concentration-time curve from time zero to the time of last measurable concentration; † Cmax, observed maximum plasma concentration; ‡ CL, total clearance of elosulfase alfa after intravenous administration; § t1/2, elimination half-life; ¶ Tmax, time from zero to maximum plasma concentration
Maltese: Tmass., minuta¶ * AUC0-t, iż-żona taħt il-kurva tal-konċentrazzjoni fil-plażma - ħin minn żero sal-ħin tal-aħħar konċentrazzjoni mkejla; † Cmass., il-konċentrazzjoni fil-plażma massima mkejla; ‡ CL, tneħħija totali tal- elosulfase alfa wara l-għoti ġol-vina; § t1/2 , eliminazzjoni tal-half-life; ¶
English: Each vial contains 5 mg elosulfase alfa in 5 ml of solution (1 mg/ml).
Maltese: Kull kunjett fih 5 mg elosulfase alfa f'5 ml ta' soluzzjoni (1 mg/ml)
English: *Elosulfase alfa is a recombinant form of human N-acetylgalactosamine-6-sulfatase (rhGALNS) and is produced in Chinese Hamster Ovary cell culture by recombinant DNA technology.
Maltese: *Elosulfase alfa huwa għamla rikombinanti ta' N-acetylgalactosamine-6-sulfatase uman (rhGALNS) uman u huwa prodott minn kultura ċellulari mill-Ovarji tal-Ħemster Ċiniż b'teknoloġija rikombinanti tad-DNA.
English: Each vial of 5 ml contains 5 mg elosulfase alfa.
Maltese: Kull kunjett ta' 5 ml fih 5 mg elosulfase alfa.
English: Date of first authorisation: 28 April 2014 Date of last renewal:
Maltese: Data tal-ewwel awtorizzazzjoni: 28 ta' April 2014
English: The sulfatase activity deficiency results in the accumulation of the GAG substrates, KS and chondroitin 6 sulphate (C6S), in the lysosomal compartment of cells throughout the body.
Maltese: In-nuqqas ta' attività ta' sulfatase jirriżulta fl-akkumulazzjoni ta' substrati ta' GAG, KS u chondroitin 6 sulphate (C6S), fil-kompartiment lisosomali ta' ċelluli fil-ġisem kollu.
English: Spinal/Cervical cord compression
Maltese: Kompressjoni tal-korda spinali/ċervikali
English: The baseline mean (±SD) normalised standing height z-score was - 1.6 (±1.61).
Maltese: Il-punteġġ z tat-tul normalizzat medju fil-linja bażi (±SD) kien -1.6 (±1.61).
English: Cmax, µg/ml†
Maltese: AUC0-t, minuta • µg/ml* Cmass., µg/ml†
English: No impairment of fertility has been observed in nonclinical studies (see section 5.3) with elosulfase alfa.
Maltese: L-ebda indeboliment relatat mal-fertilità ma ġie osservat fi studji mhux kliniċi (ara sezzjoni 5.3) b'elosulfase alfa.
English: Vimizim 1 mg/ml concentrate for solution for infusion elosulfase alfa
Maltese: Vimizim 1 mg/ml konċentrat għal soluzzjoni għall-infużjoni elosulfase alfa
English: The primary and secondary endpoints were evaluated at Week 24 (see Table 3).
Maltese: Il-punti ta' riferiment prinċipali u sekondarji ġew ivvalutati f'Ġimgħa 24 (ara Tabella 3).
English: At Week 104 mean (±SD) normalised standing height z-score was -3.1 (±
Maltese: Il-punteġġ z tat-tul normalizzat medju (±SD) f'Ġimgħa 104 kien -3.1 (±1.13).
English: Elosulfase alfa is a protein and is expected to be metabolically degraded through peptide hydrolysis.
Maltese: Elosulfase alfa huwa proteina u jkun mistenni li jiġi degradat metabolikament permezz ta' idrolisi talpeptidi.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of solution contains 1 mg elosulfase alfa*.
Maltese: U KWANTITATTIVA Kull ml ta' soluzzjoni fih 1 mg elosulfase alfa*.
English: This medicinal product contains 8 mg sodium per vial, equivalent to 0.4% of the WHO recommended maximum daily intake of 2 g sodium for an adult, and is administered in sodium chloride 9 mg/ml (0.9%) solution for infusion (see section 6.6).
Maltese: Dan il-prodott mediċinali fih 8 mg sodju f'kull kunjett, ekwivalenti għal 0.4% tal-konsum massimu rakkomandat ta' kuljum mill-WHO (World Health Organisation) ta' 2 g sodju għal adult, u jingħata f'soluzzjoni ta' 9 mg/ml (0.9%) sodium chloride għall-infużjoni (ara sezzjoni 6.6).
English: The assessment of adverse reactions is based on the exposure of 176 patients with MPS IVA, ages 5 to 57 years old to 2 mg/kg elosulfase alfa once a week (n=58), 2 mg/kg elosulfase alfa once every other week (n=59), or placebo (n=59) in a randomised, double-blind, placebo-controlled study.
Maltese: L-istima tar-reazzjonijiet avversi hi bbażata fuq l-esponiment ta' 176 pazjent b'MPS IVA li l-età tagħhom tvarja minn 5 sa 57 sena għal 2 mg/kg elosulfase alfa darba fil-ġimgħa (n=58), 2 mg/kg elosulfase alfa ġimgħa iva u ġimgħa le (n=59), jew plaċebo (n=59) fi studju każwali, double-blind u kkontrollat bi plaċebo.
English: The majority of the patients presented with short stature, impaired endurance, and musculoskeletal symptoms.
Maltese: Il-maġġoranza tal-pazjenti ppreżentati kienu ta' statura baxxa, felħan indebolit, u b'sintomi muskoluskeletriċi.
English: Approximately 80% of patients developed neutralizing antibodies capable of inhibiting the elosulfase alfa from binding to the cationindependent mannose-6-phosphate receptor.
Maltese: Madwar 80% tal-pazjenti żviluppaw antikorpi newtalizzanti li kapaċi jimpedixxu elosulfase alfa milli jintrabat mar-riċettatur indipendenti mill-cation mannose-6-phosphatase.
English: This medicine contains 100 mg sorbitol in each 5 ml vial which is equivalent to 40 mg/kg.
Maltese: Din il-mediċina fiha 100 mg sorbitol f'kull kunjett ta' 5 ml li huwa ekwivalenti għal 40 mg/kg.
English: In patients < 5 years of age, the overall safety profile of Vimizim at 2 mg/kg/week was consistent with the safety profile of Vimizim observed in older children.
Maltese: F'pazjenti b'età ta' < 5 snin, il-profil tas-sigurtà globali ta' Vimizim f'doża ta' 2 mg/kg/ġimgħa kien konsistenti mal-profil tas-sigurtà ta' Vimizim osservat fi tfal akbar.
English: The modelled treatment effect in the distance walked in 6 minutes, compared to placebo, was 22.5 m (CI95, 4.0, 40.9; p=0.0174) for the 2 mg/kg per week regimen.
Maltese: L-effett modellat tal-kura fid-distanza koperta bil-mixi f'6 minuti, meta mqabbel mal-plaċebo, kien ta' 22.5 m (Cl95, 4.0, 40.9; p=0.0174) għall-programm ta' kura ta' 2 mg/kg fil-ġimgħa.
English: Mean SD
Maltese: Medja ± SD
English: This medicine may improve the symptoms of MPS IVA.
Maltese: Din il-mediċina tista' ttejjeb is-sintomi ta' MPS IVA.
English: Elosulfase alfa is intended to provide the exogenous enzyme N-acetylgalactosamine-6-sulfatase that will be taken up into the lysosomes and increase the catabolism of the GAGs KS and C6S.
Maltese: Elosulfase alfa huwa maħsub biex jipprovdi l-enzima esoġena N-acetylgalactosamine-6-sulfatase li tittieħed ġol-lisosomi u biex jiżdied il-kataboliżmu tal-GAGs, KS u C6S.
English: The safety and efficacy of Vimizim was assessed in a randomised, double-blind, placebo-controlled, Phase 3 clinical study of 176 patients with MPS IVA, ranging in age from 5 to 57 years.
Maltese: Is-sigurtà u l-effikaċja ta' Vimizim ġew ivvalutati fi studju kliniku każwali ta' Fażi 3, li kien doubleblind u kkontrollat bi plaċebo b'176 pazjent b'MPS IVA, b'etajiet li jvarjaw minn 5 snin sa 57 sena.
English: Chemical and physical in-use stability has been demonstrated for up to 24 hours at 2C - 8C followed by up to 24 hours at 23C - 27C.
Maltese: L-istabilità kimika u fiżika waqt l-użu ntweriet għal massimu ta' 24 siegħa f'temperatura ta' 2C8C segwita sa massimu 24 siegħa f'temperatura ta' 23C - 27C.
English: • Patient dose (mg) divided by 1 (mg/ml concentrate of Vimizim) = Total number of ml of
Maltese: • Doża tal-pazjent (mg) diviża b'1 (mg/ml konċentrat ta' Vimizim) = Għadd totali ta' ml ta'
English: After the first 52 weeks of treatment the normalised standing height z-score was -1.9 (±1.62).
Maltese: Wara l-ewwel 52 ġimgħa ta' trattament il-punteġġ z tat-tul normalizzat kien -1.9 (±1.62).
English: Keep this leaflet.
Maltese: Reazzjonijiet ta' infużjoni
English: However, patients with positive neutralizing antibodies responses had decreased total clearance (CL) values and prolonged t1/2.
Maltese: Madanakollu, pazjenti b'risponsi pożittivi minn antikorpi newtralizzanti naqqsu l-valuri totali ta' eliminazzjoni totali (CL) u tawwlu t1/2.
English: Musculoskeletal and connective Myalgia
Maltese: Disturbi muskolu-skeletriċi u tat-tessuti konnettivi
English: Medicinal products containing sorbitol/fructose given intravenously may be lifethreatening.
Maltese: Prodotti mediċinali li jkun fihom sorbitol/fructose li jingħata ġol-vina jistgħu jkunu ta' periklu għall-ħajja.
English: Patients who could walk more than 30 meters (m) but less than 325 m in a 6 Minute Walk Test (MWT) at baseline were enrolled in the study.
Maltese: Pazjenti li setgħu jimxu aktar minn 30 metru (m) imma inqas minn 325 m f'Test tal-Mixi fuq 6 Minuti (6MWT-6 minute walk test) bħala linja bażi ġew reġistrati fl-istudju.
English: The modelled treatment effect for the percent change in urine KS, compared to placebo, was -40.7 % (CI95, -49.0, -32.4; p<0.0001) for the 2 mg/kg per week regimen.
Maltese: L-effett modellat tal-kura għall-bidla perċentwali tal-KS fl-awrina, meta mqabbla ma' plaċebo, kienet -40.7 % (Cl95. -49.0. -32.4; p<0.0001) għall-programm ta' kura b'2 mg/kg fil-ġimgħa.
English: When diluted with 250 ml sodium chloride 9 mg/ml (0.9 %) solution for infusion; the initial rate will be 6 ml/hr.
Maltese: Meta jiġi dilwit b'250 ml ta' 9 mg/ml (0.9 %) sodium chloride soluzzjoni għall-infużjoni; irrata inizjali għandha tkun ta' 6 ml/hr.
English: The majority of patients who received Vimizim during clinical studies were in the paediatric and adolescent age range (5 to 17 years).
Maltese: Il-maġġoranza tal-pazjenti li rċevew Vimizim waqt l-istudji kliniċi kienu fil-medda ta' etajiet pedjatriċi u adolexxenti (5 sa 17-il sena).
English: Table 2: Adverse reactions in patients treated with Vimizim
Maltese: Tabella 2: Reazzjonijiet avversi f'pazjenti kkurati b'Vimizim
English: In an open-label study, 15 paediatric patients with MPS IVA under the age of 5 years (9 months to <5 years) received 2 mg/kg of Vimizim once a week for 52 weeks.
Maltese: Fi studju open-label, 15-il pazjent pedjatriku b'MPS IVA b'età inqas minn 5 snin (9 xhur sa <5 snin) irċevew 2 mg/kg ta' Vimizim darba fil-ġimgħa għal 52 ġimgħa.
English: Patients received elosulfase alfa 2 mg/kg every week (n=58) or 2 mg/kg every other week (n=59), or placebo (n=59) for a total of 24 weeks.
Maltese: Il-pazjenti rċevew elosulfase alfa 2 mg/kg kull ġimgħa (n=58) jew 2 mg/kg ġimgħa iva u ġimgħa le (n=59), jew plaċebo (n=59) għal total ta' 24 ġimgħa.