FrancophonIA/ELRC3.0 huggingface dataset:
English: This medicine contains sodium and is administered in 0.9% sodium chloride intravenous solution.
Maltese: Dan il-mediċina fiha s-sodium u tingħata f'soluzzjoni ta' 0.9% sodium chloride ġol-vini.
English: Eighty-nine percent of Q4- and 100% of Q2-treated patients met the therapeutic goals-based endpoint; the difference was not statistically significant based on the 95% CI (-0.231, 0.060).
Maltese: Disa' u tmenin fil-mija tal-pazjenti kkurati fi Q4, u 100% ta' dawk ikkurati fi Q2, issodisfaw l endpoint terapewtiku bbażat fuq il-miri; id-differenza ma kinitx statistikament sinifikanti bbażata fuq il-95% CI (-0.231, 0.060).
English: EU/1/97/053/001 Cerezyme 200 Units 1 vial of powder for concentrate for solution for infusion EU/1/97/053/002 Cerezyme 200 Units 25 vials of powder for concentrate for solution for infusion EU/1/97/053/003 Cerezyme 400 Units 1 vial of powder for concentrate for solution for infusion EU/1/97/053/004 Cerezyme 400 Units 5 vials of powder for concentrate for solution for infusion EU/1/97/053/005 Cerezyme 400 Units 25 vials of powder for concentrate for solution for infusion
Maltese: NUMRI TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/97/053/003 kunjett wieħed ta' trab għal konċentrat għal soluzzjoni għall-infużjoni EU/1/97/053/004 5 kunjetti ta' trab għal konċentrat għal soluzzjoni għall-infużjoni EU/1/97/053/005 25 kunjett ta' trab għal konċentrat għal soluzzjoni għall-infużjoni
English: The volume of distribution corrected for weight ranged from 0.09 to 0.15 l/kg (mean ± S.D 0.12 ± 0.02 l/kg).
Maltese: Il-volum tad-distribuzzjoni aġġustata għall-piż tvarja minn 0.09 sa 0.15 1/kg (medju ± S.D 0.
English: Genzyme Europe B.V. Paasheuvelweg 25
Maltese: Genzyme Europe B.V.-NL
English: For storage conditions after dilution of the medicinal product, see section 6.3.
Maltese: Għall-kondizzjonijiet ta' ħażna wara d-dilwizzjoni tal-prodott mediċinali, ara s-sezzjoni 6.3.
English: The most frequent disease manifestations are hepatosplenomegaly, thrombocytopenia, anaemia, and skeletal pathology, The skeletal abnormalities are frequently the most debilitating and disabling features of Gaucher disease.
Maltese: Il manifestazzjonijiet l-aktar frekwenti tal-marda huma epatosplenomegalija, tromboċitopenija, anemija, u patoloġija skeletrika.
English: As with any intravenous protein product, severe allergic-type hypersensitivity reactions are possible, but occur uncommonly.
Maltese: Bħal f'prodott ta' proteina li tingħata ġol-vina, reazzjonijiet ta' sensittività eċċessiva dovuti għal allerġiji severi huma possibbli iżda jseħħu b'mod mhux komuni.
English: These skeletal manifestations include bone marrow infiltration, osteonecrosis, bone pain and bone crises, osteopenia and osteoporosis, pathological fractures, and growth impairment.
Maltese: Dawn il-manifestazzjonijiet skeletriċi jinkludu infiltrazzjoni fil-mudullun, osteonekrosi, uġigħ fl-għadam u kriżi fl-għadam, osteopenija u osteoporożi, ksur patoloġiku, u indeboliment fit-tkabbir.
English: Cerezyme is supplied in type I borosilicate (clear) glass 20 ml vials.
Maltese: Cerezyme jista' jinkiseb f'kunjetti tal-ħġieġ tal-borosilicate tip I (ċar) ta' 20 ml.
English: This enzyme breaks down glucosylceramide, a key component of the lipid structure of cell membranes, into glucose and ceramide.
Maltese: Din l-enzima tkisser glucosylceramide, komponent ewlieni tal-istruttura tal-lipidi tal-membrani taċ-ċelluli, fi glucose u ceramide.
English: In a study investigating 2 cohorts of patients treated with a median dose of 80 U/kg body weight every 4 weeks and a median dose of 30 U/kg body weight every 4 weeks, among the patients with bone marrow burden score ≥ 6, more patients in the higher dose cohort (33%; n=22) achieved a decrease in the score of 2 points after 24 months of Cerezyme treatment compared with patients in the lower dose cohort (10%; n=13) (de Fost et al, 2006).
Maltese: Fi studju li investiga 2 koorti ta' pazjenti kkurati b'doża medjana ta' 80 U/kg ta' piż tal-ġisem kull 4 ġimgħat u b'doża medjana ta' 30 U/kg ta' piż tal-ġisem kull 4 ġimgħat, fost il-pazjenti b'punteġġ tal burden tal-mudullun ta' ≥ 6, iktar pazjenti fil-koorti tad-doża ogħla (33%; n=22), kisbu tnaqqis fil punteġġ ta' 2 punti wara 24 xahar ta' kura b'Cerezyme meta mqabbel ma' pazjenti fil-koorti iktar baxx tad-doża (10%; n=13) (de Fost et al, 2006).
English: After reconstitution, each vial of Cerezyme contains 400 units of imiglucerase in 10.0 ml (40 units per ml).
Maltese: Cerezyme fih 400 unità ta' imugluċerasi f'10.0 ml (40 unità kull ml).
English: In an ICGG Gaucher Registry analysis of a large cohort of patients (n=528) with Gaucher disease type 1, a time- and dose-dependent effect for Cerezyme was observed for haematological and visceral parameters (platelet count, haemoglobin concentration, spleen and liver volume) within the dose range of 15, 30 and 60 U/kg body weight once every 2 weeks.
Maltese: tip 1, kien osservat effett li jiddependi mid-doża u miż-żmien għal Cerezyme, għal parametri ematoloġiċi u vixxerali (għadd tal-plejtlits, konċentrazzjoni fl-emoglobina, fil-milsa u fil-volum talfwied) fil-medda tad-doża ta' 15, 30 u 60
English: Dizziness, headache, paraesthesia*
Maltese: Sturdament,uġigħ ta' ras, paraestesija*
English: The product diluted in 0.9% sodium chloride intravenous solution will retain chemical stability if stored up to 24 hours at 2°C and 8°C under protection from light; but microbiological safety will depend on the reconstitution and dilution having been performed aseptically.
Maltese: Il-prodott dilwit f'soluzzjoni ta' 0.9% ta' sodium chloride li tingħata ġol-vina ser iżomm l-istabbilità kemikali jekk tinħażen sa 24 siegħa f'temperatura ta' bejn 2° Ċ u 8° Ċ u f'post li ma jarax id-dawl; imma s-sigurtà mikrobijoliġikali ser tiddependi minn jekk ir-rikostituzzjoni u dilwazzjoni sarux b'mod asettiku.
English: Tachycardia*, cyanosis*
Maltese: Takikardija*,
English: It appears that patients who will develop IgG antibody are most likely to do so within 6 months of treatment and will rarely develop antibodies to Cerezyme after 12 months of therapy.
Maltese: IgG wisq probabbli jagħmlu dan fi żmien 6 xhur u jkunu qed jingħataw kura u rarament jiżviluppaw anti-korpi għal Cerezyme wara 12-il xahar ta' terapija.
English: The reconstituted solution contains 40 units imiglucerase per ml.
Maltese: Dilwazzjoni Is-soluzzjoni rikostitwita fiha 40 unità imigluceras kull ml.
English: After reconstitution, each vial of Cerezyme contains 200 units of imiglucerase in 5.0 ml (40 units per ml).
Maltese: Cerezyme fih 200 unità ta' imugluċerasi f'5.0 ml (40 unità kull ml).
English: Cerezyme contains no preservatives.
Maltese: Cerezyme ma fih l-ebda preservattivi.
English: After reconstitution, the solution contains 0.62 mmol sodium (200 U/5 mL).
Maltese: Wara r-rikostituzzjoni, is-soluzzjoni jkun fiha 0.62 mmol sodju (200 U/5
English: * An enzyme unit (U) is defined as the amount of enzyme that catalyses the hydrolysis of one micromole of the synthetic substrate para-nitrophenyl β-D-glucopyranoside (pNP-Glc) per minute at 37°C.
Maltese: *Unità (U) ta' enzima hi definita bħala l-ammont ta' enzima li tikkatalizza l-idrolisi ta' mikromol wieħed tas-substrat sintetiku para-nitrophenyl β-D glucopyranoside (pNP-Glc) kull minuta f'temperatura ta' 37° Ċ. **Imiglucerase hu forma modifikata ta' acid β-glucosidase uman u hu magħmul minn teknoloġija ta' DNA rikombinanti bl-użu ta' koltura taċ-ċelluli tal-Ovarju tal-Ħamster Ċiniż (CHO)
English: It is recommended to administer the diluted solution through an in-line low protein-binding 0.2 µm filter to remove any protein particles.
Maltese: Hu rakkomandat li tagħti s-soluzzjoni dilwita minn ġo filtru tat-tip in-line low protein-binding 0.2
English: Cerezyme 400 Units powder for concentrate for solution for infusion This medicinal product contains sodium and is administered in 0.9% sodium chloride intravenous solution (see section 6.6).
Maltese: Cerezyme 400 Unità trab għal konċentrat għal soluzzjoni għall-infużjoni Dan il-prodott mediċnali fih is-sodju u jiġi mogħti f'soluzzjoni ta' 0.9% ta' sodium chloride ġol-vina (ara sezzjoni 6.6).
English: These symptoms generally respond to treatment with antihistamines and/or corticosteroids.
Maltese: Dawn is sintomi ġeneralment jirrispondu għat-trattament b'antiħistamini u/jew kortikosterojdi.
English: Patients who have developed antibodies or symptoms of hypersensitivity to Ceredase (alglucerase) should be treated with caution when administering Cerezyme (imiglucerase).
Maltese: Pazjenti li żviluppaw anti-korpi jew sintomi ta' sensittività eċċessiva għal Ceradese (alglucerase) għandhom ikunu ikkurati b'attenzjoni meta jingħataw Cerezyme (imiglucerase).
English: Cerezyme 200 Units Powder for concentrate for solution for infusion Cerezyme 400 Units Powder for concentrate for solution for infusion
Maltese: Cerezyme 200 Unità Trab għal konċentrat għal soluzzjoni għall-infużjoni Cerezyme 400
English: Due to the heterogeneity and the multi-systemic nature of Gaucher disease, dosage should be individualised for each patient based on a comprehensive evaluation of all clinical manifestations of the disease.
Maltese: Minħabba l-eteroġeneità u n-natura multi-sistematika tal-marda Gaucher, id-doża għandha tkun individwalizata għal kull pazjent skond evalwazzjoni komprensiva tas-sinjali kliniċi kollha talmarda.
English: Infusion of Cerezyme by the patient or caregiver at home requires training by a health care professional in a clinical setting.
Maltese: Infużjonijiet sussegwenti jista' jkollhom bżonn li jsiru fi sfond kliniku.
English: You may need to be given additional medicines to prevent an allergic reaction (e.g. antihistamines and/or corticosteroids).
Maltese: Jista' jkun li tingħata mediċini oħra sabiex tipprevjeni reazzjoni allerġika (eż. anti-ħistamini u/jew kortikosterojdi).
English: Pack sizes: 1 or 25 vials per carton.
Maltese: Kunjett 1 jew 25 kunjett kull kartuna.
English: Cerezyme 200 Units powder for concentrate for solution for infusion This medicinal product contains sodium and is administered in 0.9% sodium chloride intravenous solution (see section 6.6).
Maltese: Cerezyme 200 Unità trab għal konċentrat għal soluzzjoni għall-infużjoni Dan il-prodott mediċnali fih is-sodju u jiġi mogħti f'soluzzjoni ta' 0.9% ta' sodium chloride ġol-vina (ara sezzjoni 6.6).
English: The requirements for submission of periodic safety update reports 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: prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikat fuq il-portal elettroniku Ewropew tal-mediċini.
English: EU/1/97/053/001 1 vial of powder for concentrate for solution for infusion EU/1/97/053/002 25 vials of powder for concentrate for solution for infusion
Maltese: EU/1/97/053/001 kunjett wieħed ta' trab għal konċentrat għal soluzzjoni għall-infużjoni EU/1/97/053/002 25 kunjett ta' trab għal konċentrat għal soluzzjoni għall-infużjoni
English: Dyspnoea*, coughing*
Maltese: Qtugħ ta' nifs*, sogħla*
English: In children, Cerezyme has been shown to enable normal pubertal development, and to induce catch-up growth, leading to normal height and bone mineral density in adulthood.
Maltese: Fit-tfal, intwera li Cerezyme jagħmilha possibbli li jkun hemm żvilupp normali fil-pubertà, u jikkawża tkabbir catch-up, li jwassal għal tul normali u densità normali tal-għadam meta l-persuna ssir adulta.
English: In individuals with Gaucher disease, glucosylceramide degradation is insufficient, leading to accumulation of large quantities of this substrate within the lysosomes of macrophages (termed ‘Gaucher cells'), leading to widespread secondary pathology.
Maltese: F'individwi bil-marda ta' Gaucher, iddegradazzjoni ta' glucosylceramide hi insuffiċjenti, u twassal għall-akkumulazzjoni ta' kwantitajiet kbar ta' dan is-substrat fil-lisosomi ta' makrofaġi (imsejħa ‘ċelluli ta' Gaucher'), li jwasslu għal patoloġija sekondarja mifruxa.
English: Do not use this medicine after the expiry date printed on the labelling after the letters “EXP”.
Maltese: Tużax din il-mediċina wara d-data ta' meta tiskadi li tidher fuq it-tikketta u l-kartuna wara “JIS”.
English: This leaflet was last revised in:
Maltese: Kunjetti mhux miftuħa:
English: This medicinal product contains sodium and is administered in 0.9% sodium chloride intravenous solution (see section 6.6).
Maltese: Dan il-prodott mediċinali fih is-sodium u jingħata f'soluzzjoni ta' 0.9% sodium chloride li tingħata ġol-vina (ara sezzjoni 6.6).
English: Cerezyme (imiglucerase) is indicated for use as long-term enzyme replacement therapy in patients with a confirmed diagnosis of non-neuronopathic (Type 1) or chronic neuronopathic (Type 3) Gaucher disease who exhibit clinically significant non-neurological manifestations of the disease.
Maltese: Cerezyme (imiglucerase) hu indikat għall-użu tat-terapija fit-tul li tinvolvi s-sostituzzjoni enzimatika f'pażjenti li għandhom dijanjosi konfermata tal-marda Gaucher li mhix newropatika (Tip 1) jew newropatika kronika (Tip 3) li juru sinjali tal-marda li huma klinikament sinifikanti u li mhux newroloġiċi.
English: • bone disease after exclusion of other causes such as Vitamin D deficiency
Maltese: • mard ta' l-għadam wara l-esklużjoni ta' kawżi oħra bħal defiċjenza tal-Vitamina D
English: This enzyme helps the body control levels of glucosylceramide.
Maltese: Din l-enżima tgħin lill-ġisem jikkontrolla l-livelli tal-glucosylceramide.
English: Urticaria/angioedema*, pruritus*, rash*
Maltese: Urtikarja/anġjodema*,
English: Patients who have undergone a splenectomy have an increased risk of pulmonary hypertension.
Maltese: Il-pazjenti li kellhom splenektomija, għandhom żieda fir-riskju għal pressjoni tad-demm pulmonari għolja.
English: Your dose will be specific to you.
Maltese: unità ta' imiglucerase.
English: Withdraw 5.0 ml reconstituted solution from each vial and combine the withdrawn volumes.
Maltese: Iġbed 5.0 ml soluzzjoni rikostitwita minn kull kunjett u ħallat il-volumi miġbuda.
English: Current data using a screening ELISA followed by a confirmatory radioimmunoprecipitation assay, suggest that, during the first year of therapy, IgG antibodies to imiglucerase are formed in approximately 15% of the treated patients.
Maltese: L-informazzjoni attwali bl-użu ta' screening ELISA segwit minn assaġġ radjuimmunopreċipitatorju konfermatorju, tissuġġerixxi li, matul l-ewwel sena ta' terapija, anti-korpi ta' l-IgG għal imiglucerase ffurmaw f'bejn wieħed u ieħor 15% tal-pazjenti li ngħataw il-kura.
English: Uncommon (may affect up to 1 in 100 people): - dizziness - headache - a sensation of tingling, pricking, burning or numbness of the skin - increased heart rate - bluish skin - flushing - fall in blood pressure - vomiting - nausea - abdominal cramping - diarrhoea - pain in the joints - infusion site discomfort - infusion site burning - infusion site swelling - injection site sterile abscess - chest discomfort - fever - rigors - fatigue - backache
Maltese: Imiglucerase (makrofagu rikombinanti targeted acid ß-glucosidase) jissostitwixxi l-attività tal enzima defiċjenti, jagħmel hydrolysing ta' glucosylceramide, u għaldaqstant jikkoreġi lpatofiżjoloġija inizjali u jimpedixxi patoloġija sekondarja. Cerezyme inaqqas id-daqs tal-milsa u tal fwied, itejjeb jew jinnormalizza t-tromboċitopenija u l-anemija, itejjeb jew jinnormalizza d-densitàminerali tal-għadam u l-burden tal-mudullun, u jnaqqas jew jelimina l-uġigħ fi kriżijiet tal-għadam.
English: Genzyme Europe B.V. - NL Store in a refrigerator.
Maltese: Genzyme Europe B.V.
English: One vial contains 200 units of imiglucerase.
Maltese: Kull kunjett fih 200 unità ta' imiglucerase.
English: Cerezyme 200 Units powder for concentrate for solution for infusion Each vial contains 200 units* of imiglucerase**.
Maltese: Kull kunjett fih 200 unità* ta' imiglucerase**.
English: Cerezyme 400 Units powder for concentrate for solution for infusion Reconstitute each vial with 10.2 ml water for injections; avoid forceful impact of water for injections on the powder and, by mixing gently, avoid foaming of the solution.
Maltese: Irrikkostitwixxi kull kunjett b'10.2 ml ta' ilma għall-injezzjonijiet; evita l-impatt qawwi ta' l-ilma għall-injezzjonijiet fuq it-trab, u ħawwad bil-mod, sabiex tevita' li s-soluzzjoni tagħmel r-ragħwa.
English: Medical or healthcare professionals are encouraged to register Gaucher patients, including those with chronic neuronopathic manifestations of the disease, in the “ICGG Gaucher Registry” (see section 5.1).
Maltese: L-effikaċja ta' Cerezyme fuq is-sintomi newroloġikali ta' pazjenti li jbatu bil-marda kronika u newronopatika tal-Gaucher ma ġietx stabbilita u ma jista' jiġi rrakkomandat l-ebda reġimen speċjali ta' dożaġġ għal dawn il-manifestazzjonijiet (ara sezzjoni 5.1).
English: Gaucher disease is associated with increased morbidity and early mortality.
Maltese: Il-marda ta' Gaucher hi assoċjata ma' żieda fil-morbożità u mortalità bikrija.
English: Cerezyme 200 Units Powder for concentrate for solution for infusion imiglucerase
Maltese: IL-PRODOTT MEDIĊINALI Cerezyme 200 Unità Trab għal konċentrat għal soluzzjoni għall-infużjoni imiglucerase
English: What Cerezyme looks like and contents of the pack
Maltese: Id-Dehra ta' Cerezyme u l-kontenuti tal-pakkett
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
Maltese: TAS-SUSTANZA BIJOLOĠIĊIKA ATTIVA U MANIFATTURI
English: Arthralgia, backache*
Maltese: Artralġja, uġigħ fid dahar*
English: The reconstituted volume is 10.6 ml.
Maltese: Ilvolum rikostitwit hu 10.6 ml.
English: Sanofi S.p.A. Tel: +39 059 349 811
Maltese: Tel: +39 059 349 811
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (1 VIAL, 25 VIALS)
Maltese: KARTUNA TA' BARRA (KUNJETT 1, 25 KUNJETT)
English: After reconstitution and dilution, the preparation is administered by intravenous infusion.
Maltese: Wara r-rikonstituzzjoni u d-dilwazzjoni, il-preparazzjoni tingħata permezz ta' infużjoni ġol-vina.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (1 VIAL, 5 VIALS, 25 VIALS)
Maltese: KARTUNA TA' BARRA (KUNJETT WIEĦED, 5
English: Similarly, in an ICGG Gaucher Registry analysis of bone mineral density using dual-energy X-ray absorptiometry (DXA) in 342 patients, after 8 years of treatment normal bone mineral density was achieved with a Cerezyme dose of 60 U/kg body weight once every 2 weeks, but not with lower doses of 15 and 30 U/kg body weight once every 2 weeks (Wenstrup et al, 2007).
Maltese: dual-energy X-ray absorptiometry (DXA) fi 342 pazjent, wara 8 snin ta' kura, densità minerali normali tal-għadam inkisbet b'doża ta' Cerezyme ta' 60
English: Maintenance therapy every 4 weeks (Q4) at the same cumulative dose as the bi-weekly (Q2) dose has been studied in adult patients with stable residual Gaucher disease type 1.
Maltese: Terapija talmanteniment kull 4 ġimgħat (Q4) bl-istess doża kumulattiva bħad-doża ta' kull ġimagħtejn (Q2),
English: Cerezyme 400 Units powder for concentrate for solution for infusion Each vial contains 400 units* of imiglucerase**.
Maltese: Kull kunjett fih 400 unità* ta' imiglucerase**.
English: Cerezyme 400 Units Powder for concentrate for solution for infusion imiglucerase
Maltese: IL-PRODOTT MEDIĊINALI Cerezyme 400 Unità Trab għal konċentrat għal soluzzjoni għall-infużjoni imiglucerase
English: Ireland sanofi-aventis Ireland Ltd. T/A SANOFI Tel: +353 (0) 1 403 56 00
Maltese: Slovenija sanofi-aventis d.o.o. Tel: +386 1 560 4800
English: Cerezyme 200 Units powder for concentrate for solution for infusion Reconstitute each vial with 5.1 ml water for injections; avoid forceful impact of water for injections on the powder and, by mixing gently, avoid foaming of the solution.
Maltese: Irrikkostitwixxi kull kunjett b'5.1 ml ta' ilma għall-injezzjonijiet; evita l-impatt qawwi ta' l-ilma għall-injezzjonijiet fuq it-trab, u ħawwad bil-mod, sabiex tevita' li s-soluzzjoni tagħmel r-ragħwa.
English: • anaemia after exclusion of other causes, such as iron deficiency
Maltese: • anemija wara l-esklużjoni ta' kawżi oħra, bħal defiċjenza tal-ħadid
English: EU/1/97/053/003 1 vial of powder for concentrate for solution for infusion EU/1/97/053/004 5 vials of powder for concentrate for solution for infusion EU/1/97/053/005 25 vial of powder for concentrate for solution for infusion
Maltese: EU/1/97/053/004 Cerezyme 400 Unità 5 kunjetti ta' trab għal konċentrat għal soluzzjoni għall infużjoni
English: After reconstitution, the solution contains 40 units (approximately 1.0 mg) of imiglucerase per ml (400 U/10 ml).
Maltese: Wara r-rikonstituzzjoni, is-soluzzjoni fiha 40 unità (madwar 1.0 mg) ta' imiglucerase kull ml, (400
English: Infusion site discomfort, infusion site burning, infusion site swelling, injection site sterile abscess, chest discomfort*, fever, rigors, fatigue
Maltese: l-infużjoni, ħruq fis sit ta' l-infużjoni, nefħa fis-sit ta' l infużjoni, axxess sterili tas-sit talinjezzjoni, Skumdità fis-sider*, deni,
English: - Keep this leaflet.
Maltese: - nuqqas ta' nifs
English: Changes from baseline in hemoglobin, platelets, liver and spleen volumes, bone crisis, and bone disease comprised a predefined composite endpoint; achievement or maintenance of established Gaucher disease therapeutic goals for the hematologic and visceral parameters comprised an additional endpoint.
Maltese: Tibdil mil-linja bażi fl emoglobina, plejtlits, volumi tal-fwied u tal-milsa, kriżi fl-għadam, u mard fl-għadam kienu jinkludu endpoint kompost pre-definit; il-kisba jew iż-żamma ta' miri terapewtiċi stabbiliti tal-marda ta' Gaucher għall-parametri ematoloġiċi u vixxerali kienu jinkludu endpoint addizzjonali.
English: Respiratory, thoracic and mediastinal disorders
Maltese: U EFFIKAĊI TAL-PRODOTT MEDIĊINALI
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Maltese: Sensittivita' eċċessiva għas-sustanza attiva jew għal kwalunkwe sustanza mhux attiva elenkat fis sezzjoni 61.
English: Mannitol, sodium citrate (to adjust pH), citric acid monohydrate (to adjust pH), polysorbate 80.
Maltese: sodium Citrate (biex ikun aġġustat il-pH), citric acid monohydrate (biex ikun aġġustat il-pH),
English: MARKETING AUTHORIZATION NUMBERS
Maltese: NUMRI TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ
English: Cerezyme has been shown to improve both mental and physical aspects in the quality of life of Gaucher disease.
Maltese: Intwera li Cerezyme itejjeb kemm l-aspetti mentali u fiżiċi tal-kwalità tal-ħajja ta' pazjenti bil-marda ta' Gaucher.
English: EU/1/08/494/005 STELARA 130 mg Concentrate for solution for infusion
Maltese: EU/1/08/494/005
English: Intravenous use vial (glass)
Maltese: Użu fil-vini kunjett (ħġieġ)
English: Manufacturer Cangene Corporation 155 Innovation Drive Winnipeg, MA R3T 5Y3
Maltese: Innovation Drive Winnipeg, MA R3T 5Y3
English: Pharmacotherapeutic group: Hepatitis B immunoglobulin, ATC code: J06BB04
Maltese: Immunoglobulina ta' epatite B, Kodiċi ATC: J06BB04
English: MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE
Maltese: MANIFATTUR TAS-SUSTANZA BIJOLOĠIKA ATTIVA
English: - The other ingredients are maltose and polysorbate 80.
Maltese: - Is-sustanzi l-oħra huma maltose u polysorbate 80.
English: ADR frequency category*
Maltese: Kategorija ta' frekwenza tal-ADR*
English: IgA content is less than 40 micrograms/ml.
Maltese: Il-kontenut ta' IgA hu inqas minn 40 mikrogramma/ml.
English: ImmunoGam has an elimination half-life of 3 - 4 weeks.
Maltese: ImmunoGam għandu half-life tal-eliminazzjoni ta' 3 - 4 ġimgħat.
English: One vial of 1 ml contains 312 IU of anti-HBs.
Maltese: Kunjett wieħed ta' 1 ml fih 312 IU ta' anti-HBs.
English: Exp:
Maltese: IgG huma:
English: Passive transmission of antibodies to erythrocyte antigens, e.g. A, B, D may interfere with some serological tests for red cell allo-antibodies (e.g.Coombs' test).
Maltese: It-trasmissjoni passiva ta' antikorpi lil antiġeni eritroċiti, eż. A, B, D, tista' tinterferixxi ma' xi testijiet seroloġiċi għal allo-antikorpi taċ-ċelluli ħomor (eż. it-test ta' Coombs).