FrancophonIA/ELRC3.0 huggingface dataset:
English: 4 g / 20 ml
Maltese: 2 g / 10 ml 4 g / 20 ml
English: All pre-filled syringes have a standard luer lock, which is a screw connection at the syringe tip that creates a leak-free seal.
Maltese: Is-siringi kollha mimlija għal-lest għandhom luer lock standard, li huwa konnessjoni b'kamin fit-tarf tas-siringa li joħloq siġill li ma jqattarx.
English: You may reduce possible side effects if you infuse Hizentraslowly.
Maltese: Inti tista' tnaqqas l-effetti sekondarji possibbli jekk tagħti l-infużjoni ta' Hizentra bil-mod.
English: The mean dose administered each week was 0.23 g/kg bw.
Maltese: Id-doża medja amministrata kull ġimgħa kienet ta' 0.23 g/kg tal-piż tal-ġisem.
English: Patients who completed the pivotal PATH study without relapse on 0.4 g/kg bw dose and initially received this dose in the extension study had a relapse rate of 5.6 % (1/18 patients).
Maltese: PATH mingħajr ma rkadew b'doża ta' 0.4 g/kg bw u inizjalment irċevew din id-doża fl-istudju ta' estensjoni kellhom rata ta' rkadar ta' 5.6 % (1/18-il pazjent).
English: Subjects received in total 2,264 weekly Hizentra infusions.
Maltese: L-individwi rċevew b'kollox 2,264 infużjoni ta' Hizentra kull ġimgħa.
English: A phase III, multicentre, 48-week open-label extension study enrolled 82 CIDP patients from the PATH study.
Maltese: III, b'aktar minn ċentru wieħed, ta' 48 ġimgħa u open-label irreġistra 82
English: • the infused volume, flow rate, the number and location of infusion sites.
Maltese: • l-volum infuż, ir-rata tal-għoti, in-numru ta' infużjonijiet u l-postijiet fejn ingħataw.
English: An infusion was considered valid, if ≥95 % of the planned flow rate/volume per ≥1 infusion site was achieved.
Maltese: Infużjoni kienet meqjusa bħala valida, jekk inkiseb ≥95 % tar-rata/volum tal-fluss ippjanat għal kull ≥1 sit tal-infużjoni.
English: Chills (including Hypothermia)
Maltese: Tkexkix ta' bard (inkluża Ipotermja)
English: The mean (SD) IgG trough concentration after Hizentra treatment in the 0.4 g/kg bw group was 20.4 (3.24) g/l and 15.4 (3.06) g/l in the 0.2 g/kg bw group.
Maltese: Ilkonċentrazzjoni l-aktar baxxa medja (SD) tal-IgG wara trattament b'Hizentra fil-grupp ta' 0.4 g/kg piż tal-ġisem kienet 20.
English: Marti Farm d.o.o.
Maltese: Siringi mimlija għal-lest
English: • Abnormal result of a blood test that may indicate impaired liver and kidney function
Maltese: • Riżultat mhux normali ta' test tad-demm li jista' jindika funzjoni indebolita tal-fwied u talkliewi
English: In the clinical studies Hizentra was evaluated in 13 patients with PID >65 years of age.
Maltese: Fl-istudji kliniċi Hizentra kien evalwat f'13-il pazjenti b'PID b'età ta' >65 sena.
English: • Do not use this medicine after the expiry date which is stated on the outer carton and the pre filled syringe label after EXP.
Maltese: • Tużax din il-mediċina wara d-data ta' meta tiskadi li tidher fuq il-kartuna ta' barra u fuq it tikketta wara
English: 11 Clean up
Maltese: 11 Naddaf
English: What Hizentra is
Maltese: Hizentra.
English: • Muscular weakness
Maltese: .8 Effetti mhux mixtieqa
English: Sustained IgG trough levels with a mean concentration of 12.53 g/l were thereby achieved throughout the treatment period.
Maltese: Livelli sostnuti l-aktar baxxi ta' IgG b'konċentrazzjonijiet medji ta' 12.53 g/l kienu b'hekk miksuba matul il-perjodu ta' trattament.
English: Pre-filled syringes
Maltese: Trattament fid-dar
English: • lack of certain immunoglobulin G subclasses causing recurrent infections.
Maltese: • nuqqas ta' ċertu immunoglobulina fis-sottoklassi G li tikkawża infezzjonijiet rikorrenti.
English: Central Nervous System (CNS)
Maltese: Sistema Nervuża Ċentrali (CNS)
English: Treatment effect (LS mean ± SE; 95.8% CI; p-value)
Maltese: 8% CI; p-value)
English: Weight in kilograms
Maltese: Piż f'kilogrammi
English: Capsule content microcrystalline cellulose methacrylic acid - ethyl acrylate copolymer (1:1) hypromellose talc triethyl citrate sodium lauryl sulphate
Maltese: Il-kontenut tal-kapsuli microcrystalline cellulose methacrylic acid - ethyl acrylate copolymer (1:1) hypromellose talc triethyl citrate sodium lauryl sulphate
English: Do not take PROCYSBI:
Maltese: Tiħux PROCYSBI:
English: Date of latest renewal: 26 July 2018
Maltese: Data tal-aħħar tiġdid: 26 Lulju 2018
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 06 September 2013
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 06 Set 2013
English: Cysteamine (mercaptamine bitartrate)
Maltese: Ċisteamina (mercaptamine bitartrate)
English: • Hypersensitivity to penicillamine.
Maltese: • Sensittività eċċessiva għall-peniċillamina.
English: The frequency of adverse reactions is defined using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000) and not known (cannot be estimated from available data).
Maltese: Il-frekwenza ta' reazzjonijiet avversi hija definita bl-użu tal-konvenzjoni li ġejja: komuni ħafna (≥1/10); komuni (≥1/100 sa <1/10); mhux komuni (≥1/1,000 sa <1/100); rari (≥1/10,000 sa <1/1,000); rari ħafna (<1/10,000) u mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: Dermatological
Maltese: Dermatoloġiċi
English: PROCYSBI contains sodium
Maltese: PROCYSBI fih sodium
English: Capsule shell gelatin titanium dioxide (E171) indigo carmine (E132)
Maltese: Il-qoxra tal-kapsuli gelatin titanium dioxide (E171) indigo carmine (E132)
English: Printing ink shellac povidone K-17 titanium dioxide (E171)
Maltese: Il-linka shellac povidone K-17 titanium dioxide (E171)
English: PROCYSBI 75 mg hard capsule EU/1/13/861/002
Maltese: PROCYSBI 75 mg kapsula iebsa EU/1/13/861/002
English: Cysteamine bitartrate is not an inhibitor of CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1 and CYP3A4 in vitro.
Maltese: Il-bitartrat taċ-ċisteamina mhuwiex inibitur ta' CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1 u CYP3A4 in vitro.
English: INFORMATION IN BRAILLE PROCYSBI 25 mg
Maltese: INFORMAZZJONI BIL-BRAILLE PROCYSBI 25 mg
English: In vitro: Cysteamine bitartrate is a substrate of P-gp and OCT2, but not a substrate of BCRP, OATP1B1, OATP1B3, OAT1, OAT3 and OCT1.
Maltese: Il-bitartrat taċ-cysteamine huwa substrat ta' P-gp u OCT2, iżda mhuwiex substrat ta' BCRP, OATP1B1, OATP1B3, OAT1, OAT3 u OCT1.
English: PROCYSBI 25 mg hard capsule EU/1/13/861/001
Maltese: PROCYSBI 25 mg kapsula iebsa EU/1/13/861/001
English: INFORMATION IN BRAILLE PROCYSBI 75 mg
Maltese: INFORMAZZJONI BIL-BRAILLE PROCYSBI 75 mg
English: • Breast-feeding.
Maltese: • It-treddigħ.
English: Uncommon: Leukopenia
Maltese: Mhux komuni: Lewkopenja
English: The other ingredients are: o In the capsules: microcrystalline cellulose, methacrylic acid - ethyl acrylate copolymer
Maltese: Is-sustanzi l-oħra huma: oFil-kapsuli: microcrystalline cellulose, methacrylic acid - ethyl acrylate copolymer (1:1),
English: Food intake reduces the absorption of PROCYSBI at 30 minutes pre-dose (approximately 35% decrease in exposure) and at 30 min post-dose (approximately 16 or 45% decrease in exposure for intact and open capsules respectively).
Maltese: L-ikel inaqqas l-assorbiment ta' PROCYSBI 30 minuta qabel id-doża (madwar 35% tnaqqis flesponiment) u 30 minuta wara d-doża (madwar 16 jew 45% tnaqqis fl-esponiment għall-kapsuli sħaħ u miftuħa rispettivament).
English: Forty-three (43) patients were randomized; twenty-seven (27) children (ages 6 to 12 years old), fifteen (15) adolescents (ages 12 to 21 years old) and one (1) adult with cystinosis and with native kidney function based on an estimated Glomerular Filtration Rate (GFR) (corrected for body surface area) > 30 mL/minute/1.73 m2
Maltese: Tlieta u erbgħin (43) pazjent intgħażlu b'mod każwali; sebgħa u għoxrin (27) tifel u tifla (etajiet bejn 6 u 12-il sena), ħmistax-il (15) adolexxenti (etajiet ta' bejn it-12 u l-21 sena) u adult wieħed (1) b'ċistinożi u b'funzjoni tal-kliewi proprji bbażata fuq stima tar-Rata ta' Filtrazzjoni Glomerulari (GFR - Glomerular Filtration Rate) (irranġata għall-erja tal-wiċċ tal-ġisem) > 30 mL/minuta/1.73 m2
English: Common: Asthenia
Maltese: Komuni: Astenja
English: In clinical studies with healthy volunteers, the most frequent adverse reactions were very common GI symptoms (16%) and occurred primarily as single episodes that were mild or moderate in severity.
Maltese: Fi studji kliniċi b'voluntiera b'saħħithom, ir-reazzjonijiet l-aktar avversi frekwenti kienu sintomi GI komuni ħafna (16%) u li seħħew l-aktar bħala episodji singoli ħfief jew ta' severità moderata.
English: An overdose of cysteamine may cause progressive lethargy.
Maltese: Doża eċċessiva ta' cysteamine tista' toħloq letarġija progressiva.
English: Benign intracranial hypertension
Maltese: Ipertensjoni intrakranjali beninna
English: Co-administration with electrolyte and mineral replacement
Maltese: L-għoti flimkien mas-sostituti tal-elettroliti u tal-minerali
English: The active substance is cysteamine (as mercaptamine bitartrate).
Maltese: Is-sustanza attiva hi ċ-cysteamine (bħala mercaptamine bitartrate).
English: Post-marketing experience with immediate-release cysteamine bitartrate Benign intracranial hypertension (or pseudotumor cerebri (PTC)) with papilledema; skin lesions, molluscoid pseudotumors, skin striae, skin fragility; joint hyperextension, leg pain, genu valgum, osteopenia, compression fracture and scoliosis have been reported with immediate-release cysteamine bitartrate (see section 4.4).
Maltese: Esperjenza ta' wara t-tqegħid fis-suq bil-bitartrat taċ-cysteamine b'rilaxx immedjat Ipertensjoni intrakranjali beninna (jew pseudotumor cerebri (PTC)) b'papilledema; ġrieħi fil-ġilda, pseudotumuri molluskojdi, marki ta' ġbid fil-ġilda, fraġilità tal-ġilda; estensjoni żejda tal-ġogi, uġigħ fis-saqajn, genu valgum, osteopenija, ksur b'kompressjoni u skoljożi ġew irrappurtati bil-bitartrat taċcysteamine b'rilaxx immedjat (ara sezzjoni 4.4).
English: The maximum recommended dose of cysteamine is 1.95 g/m2/day.
Maltese: Id-doża massima rakkomandata ta' cysteamine hija 1.95 g/m2/jum.
English: PROCYSBI 75 mg hard capsule
Maltese: PROCYSBI 75 mg kapsula iebsa
English: PHARMACEUTICAL FORM AND CONTENTS Gastro-resistant hard capsule 250 capsules
Maltese: U KONTENUT Kapsula iebsa gastro-reżistenti 250 kapsula
English: It cannot be excluded that cysteamine is a clinically relevant inducer of CYP enzymes, inhibitor of P-gp and BCRP at the intestinal level and inhibitor of liver uptake transporters (OATP1B1, OATP1B3 and OCT1).
Maltese: Ma jistax ikun eskluż li ċ-cysteamine hija induttur klinikament rilevanti tal-enzimi CYP, inibitur ta' P-gp u BCRP fil-livell intestinali u inibitur tat-trasportaturi tal-assorbiment tal-fwied (OATP1B1, OATP1B3 u OCT1).
English: PHARMACEUTICAL FORM AND CONTENTS Gastro-resistant hard capsule 60 capsules
Maltese: U KONTENUT Kapsula iebsa gastro-reżistenti 60 kapsula
English: A reduction of fertility was observed in rats at 375 mg/kg/day, a dose at which body weight gain was retarded.
Maltese: Tnaqqis fil-fertilità kien osservat fil-firien bi 375 mg/kg/jum, doża li biha ż-żieda fil-piż tal-ġisem kien ritardat.
English: Thirty-nine (39) patients were included in the final primary per protocol efficacy analysis.
Maltese: Disgħa u tletin (39) pazjent kienu inklużi fl-analiżi finali primarja skont il-protokoll tal-effikaċja.
English: PROCYSBI is indicated for the treatment of proven nephropathic cystinosis.
Maltese: PROCYSBI huwa indikat għall-kura ta' ċistinożi nefropatika pprovata.
English: The targeted maintenance dose is 1.3 g/m2/day.
Maltese: Id-doża ta' manutenzjoni fil-mira hija 1.3 g/m2/jum.
English: Per -Protocol (PP) Population (N=39) Immediate-release cysteamine bitartrate
Maltese: Popolazzjoni (N=39) Skont il-Protokoll (PP) Bitartrat taċ-cysteamine b'rilaxx immedjat
English: In vitro data suggests that cysteamine bitartrate is likely to be metabolized by multiple CYP enzymes, including CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, and CYP2E1.
Maltese: Dejta in vitro tindika li l-bitartrat taċ-cysteamine aktarx li jkun metabolizzat minn diversi enzimi CYP, inklużi CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, u CYP2E1. CYP2A6 u CYP3A4 ma kinux involuti fil-metaboliżmu tal-bitartrat taċ-cysteamine fil-kondizzjonijiet sperimentali.
English: Discard Date:
Maltese: Data meta nfetaħ:
English: * measured using the mixed leukocyte assay
Maltese: * imkejjel permezz ta' analiżi tal-lewkoċiti mħallta
English: Each gastro-resistant hard capsule contains 25 mg or 75 mg of cysteamine.
Maltese: Kull kapsula iebsa gastroreżistenti fiha 25 mg jew 75 mg ta' cysteamine.
English: PROCYSBI 25 mg hard capsule
Maltese: PROCYSBI 25 mg kapsula iebsa
English: Different organs are affected at different ages.
Maltese: Organi differenti jkunu affettwati f'etajiet differenti.
English: The in vitro plasma protein binding of cysteamine, primarily to albumin, is approximately 54% and independent of plasma drug concentration over the therapeutic range.
Maltese: It-tagħqid tal-proteina tal-plażma in vitro taċ-cysteamine, l-aktar mal-albumina, huwa madwar 54% u indipendenti mill-konċentrazzjoni tal-mediċina fil-plażma tul il-medda terapewtika.
English: Marketing Authorisation Holder Chiesi Farmaceutici S.p.A.
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq Chiesi Farmaceutici S.p.A.
English: The dose of 1.95 g/m2/day of immediate-release cysteamine bitartrate has been associated with an increased rate of withdrawal from treatment due to intolerance and an increased incidence of adverse events.
Maltese: Id-doża ta' 1.95 g/m2/jum ta' bitartrat taċ-cysteamine b'rilaxx immedjat ġiet assoċjata ma' rata ogħla ta' rtirar mill-kura minħabba nuqqas ta' tolleranza u inċidenza ogħla ta' avvenimenti avversi.
English: Benign intracranial hypertension, also called pseudotumor cerebri, has been reported with cysteamine use.
Maltese: Ipertensjoni intrakranjali beninna, imsejħa wkoll pseudotumor cerebri, ġiet irrappurtata bl-użu taċ-cysteamine.
English: • Hypersensitivity to the active substance, any form of cysteamine (mercaptamine), or to any of the excipients listed in section 6.1.
Maltese: • Sensittività eċċessiva għas-sustanza attiva, kwalunkwe forma ta' cysteamine (merkaptamina),
English: 0.08 ± 0.03; 0.01 to 0.15; <0.0001 All Evaluable Patients (ITT) Population (N=41) Immediate-release cysteamine bitartrate
Maltese: 0.08 ± 0.03; 0.01 to 0.15; <0.0001
English: Clinical studies experience with PROCYSBI
Maltese: Mediċini oħra u PROCYSBI
English: CNS symptoms such as seizures, lethargy, somnolence, depression, and encephalopathy have been associated with cysteamine.
Maltese: Sintomi tas-CNS bħal aċċessjonijiet, letarġija, ngħas, depressjoni, u enċefalopatija ġew assoċjati maċcysteamine.
English: This is equivalent to 0.6 g/m2/day in the rat, which is slightly less than the recommended clinical maintenance dose of cysteamine, i.e. 1.3 g/m2/day.
Maltese: Dan huwa ekwivalenti għal 0.6 g/m2/jum fil-far, li huwa xi ftit inqas mid-doża klinika ta' manteniment irrakkomandata ta' cysteamine, jiġifieri 1.3 g/m2/jum.
English: Cysteamine is the simplest stable aminothiol and a degradation product of the amino acid cysteine.
Maltese: Iċ-cysteamine hija l-aminothiol stabbli l-aktar sempliċi u prodott ta' degradazzjoni tal-aċidu amino ċisteina.
English: Do not use this medicine if you are breastfeeding (see section 2 under “Do not use PROCYSBI”).
Maltese: Tużax din il-mediċina jekk qiegħda tredda' (ara sezzjoni 2 taħt “Tużax PROCYSBI”).
English: A white plastic bottle contains 250 capsules.
Maltese: Flixkun abjad tal-plastik fih 250 kapsula.
English: A white plastic bottle contains 60 capsules.
Maltese: Flixkun abjad tal-plastik fih 60 kapsula.
English: This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially “sodiumfree.”
Maltese: Din il-mediċina fiha anqas minn 1 mmol sodium (23 mg) f'kull doża, jiġifieri essenzjalment “ħielsa mis-sodium”.
English: Light blue size 3 hard capsules imprinted “25 mg” in white ink and a light blue cap imprinted with “PRO” in white ink.
Maltese: Kapsuli ibsin blu ċar ta' daqs 3 b'“25 mg” stampata fuqhom b'linka bajda u tapp blu ċar stampat bil-Logo “PRO” b'linka bajda.
English: Common: Liver function tests abnormal
Maltese: Komuni: Testijiet anormali tal-funzjoni tal-fwied
English: A pivotal phase 3 randomized, crossover PK and PD study (which was also the first ever randomized study with immediate-release cysteamine bitartrate) demonstrated that at steady-state, patients receiving PROCYSBI every 12 hours (Q12H) maintained a comparable depletion of WBC cystine levels compared to immediate-release cysteamine bitartrate every 6 hours (Q6H).
Maltese: Studju pivitali tat-tielet fażi, crossover u b'mod każwali tal-PK u tal-PD (li kien ukoll l-ewwel studju b'mod każwali li qatt sar bil-bitartrat taċ-cysteamine b'rilaxx immedjat) wera li fi stat stabbli, ilpazjenti li ngħataw PROCYSBI kull 12-il siegħa (Q12H) żammew tnaqqis komparabbli tal-livelli ta' ċistina fil-WBC meta mqabbla mal-bitartrat taċ-cysteamine b'rilaxx immedjat kull sitt sigħat (Q6H).
English: If you are allergic to penicillamine.
Maltese: Jekk inti allerġiku għall-penicillamine.
English: PROCYSBI 25 mg gastro-resistant hard capsules PROCYSBI 75 mg gastro-resistant hard capsules
Maltese: PROCYSBI 25 mg kapsuli ibsin gastro-reżistenti PROCYSBI 75 mg kapsuli ibsin gastro-reżistenti
English: Normal individuals and persons heterozygous for cystinosis have white blood cell cystine levels of < 0.2 and usually below 1 nmol hemicystine/mg protein, respectively, when measured using the mixed leukocyte assay.
Maltese: L-individwi normali u l-persuni eterozigoti għaċ-ċistinożi jkollhom livelli ta' ċistina fiċ-ċelloli bojod tad-demm ta' < 0.2 u normalment taħt 1 nmol emiċistina/mg ta' proteina, rispettivament, meta mkejjel permezz ta' analiżi tal-lewkoċiti mħallta.
English: Cystine build-up causes kidney damage and excretion of excess amounts of glucose, proteins, and electrolytes.
Maltese: L-akkumulazzjoni taċ-ċistina tikkawża ħsara fil-kliewi u leskrezzjoni ta' ammonti żejda ta' glukożju, proteini, u elettroliti.
English: Important information about some of the excipients of PROCYSBI This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially sodiumfree.
Maltese: Dan il-prodott mediċinali fih anqas minn 1 mmol sodium (23 mg) f'kull doża, jiġifieri essenzjalment ‘ħieles mis-sodium'.
English: Histology showed a membranous glomerulonephritis of the renal allograft in one case and hypersensitivity interstitial nephritis in the other.
Maltese: L-istoloġija wriet glomerulonefrite fil-membrani talallograft renali f'każ minnhom u nefrite interstizjali ta' ipersensittività fl-ieħor.
English: Strictures of the ileo-caecum and large bowel (fibrosing colonopathy) was first described in cystic fibrosis patients who were given high doses of pancreatic enzymes in the form of tablets with an enteric coating of methacrylic acid - ethyl acrylate copolymer (1:1), one of the excipients in PROCYSBI.
Maltese: Kontrazzjonijiet tal-ileo-caecum u tal-musrana l-kbira (fibrosing colonopathy) ġew deskritti l-ewwel darba f'pazjenti b'fibrożi ċistika li ngħataw dożi għoljin ta' enzimi tal-frixa fil-forma ta' pilloli b'kisja enterika ta' kopolimeru tal-akrilat aċidu-etil metakriliku (1:1), wieħed mill-eċċipjenti fi PROCYSBI.
English: A few cases of Ehlers-Danlos-like syndrome on elbows have been reported in children chronically treated with high doses of different cysteamine preparations (cysteamine chlorhydrate or cystamine or cysteamine bitartrate) mostly above the maximal dose 1.95 g/m2/day.
Maltese: Ġew irrappurtati ftit każijiet ta' sindromu simili għal Ehlers-Danlos fuq il-minkbejn fi tfal ikkurati b'mod kroniku b'dożi għoljin ta' preparazzjonijiet differenti ta' cysteamine (kloroidrat taċ-cysteamine jew bitartrat taċ-cysteamine) l-aktar 'il fuq mid-doża massima ta' 1.95 g/m2/jum.
English: Uncommon: Anaphylactic reaction Metabolism and nutrition disorders Very common: Anorexia Psychiatric disorders
Maltese: Disturbi fis-sistema immunitarja Mhux komuni: Reazzjoni anafilattika Disturbi fil-metaboliżmu u nnutrizzjoni
English: White blood cell (WBC) cystine concentration may for instance be measured by a number of different techniques such as specific WBC subsets (e.g., granulocyte assay) or the mixed leukocyte assay with each assay having different target values.
Maltese: Il-konċentrazzjoni ta' ċisteina fiċ-ċelluli bojod tad-demm (WBC - white blood cell) tista' pereżempju titkejjel permezz ta' numru ta' tekniki differenti bħal sottogruppi ta' WBC speċifiċi (eż., analiżi talgranuloċiti) jew l-analiżi ta' lewkoċiti mħallta u kull analiżi jkollu valuri fil-mira differenti.
English: Pharmacotherapeutic group: Other alimentary tract and metabolism product, ATC code: A16AA04.
Maltese: Prodott ieħor tal-metaboliżmu u tal-passaġġ alimentari, Kodiċi ATC:
English: Teratogenic effects have been described in rats when cysteamine is administered over the period of organogenesis at a dose of 100 mg/kg/day.
Maltese: Ġew deskritti effetti teratoġeniċi fil-firien meta ċ-cysteamine tingħata waqt il-perjodu ta' organoġenesi f'doża ta' 100 mg/kg/jum.
English: Detailed information on this medicine is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu.
English: As a precaution, unusual abdominal symptoms or changes in abdominal symptoms should be medically assessed to exclude the possibility of fibrosing colonopathy.
Maltese: Bħala prekawzjoni, sintomi addominali mhux tas-soltu jew bidliet fis-sintomi addominali għandhom ikunu evalwati b'mod mediku sabiex tiġi eskluża l-possibbiltà ta' fibrosing colonopathy.
English: Uncommon: Nephrotic syndrome Very common: Lethargy, pyrexia
Maltese: Komuni: Riħa anormali fil-ġilda, raxx
English: Uncommon: Joint hyperextension, leg pain, genu valgum, osteopenia, compression fracture, scoliosis.
Maltese: Mhux komuni: Estensjoni żejda tal-ġogi, uġigħ fissaqajn, genu valgum, osteopenija, ksur b'kompressjoni, skoljożi.
English: Uncommon: Gastrointestinal ulcer Common: Skin odour abnormal, rash
Maltese: Mhux komuni: Ulċera gastro-intestinali
English: NAME OF THE MEDICINAL PRODUCT PROCYSBI 75 mg gastro-resistant hard capsules cysteamine
Maltese: TAL-PRODOTT MEDIĊINALI PROCYSBI 75 mg kapsuli ibsin gastro-reżistenti cysteamine
English: PROCYSBI contains the active substance cysteamine (also known as mercaptamine) and is taken for the treatment of nephropathic cystinosis in children and adults.
Maltese: PROCYSBI fih is-sustanza attiva cysteamine (magħrufa wkoll bħala mercaptamine) u jittieħed għallkura ta' ċistinożi nefropatika fit-tfal u fl-adulti.
English: Light blue size 0 hard capsules imprinted “75 mg” in white ink and a dark blue cap imprinted with “PRO” in white ink.
Maltese: Kapsuli ibsin blu ċar ta' daqs 0 b'“75 mg” stampata fuqhom b'linka bajda u tapp blu skur stampat bil-Logo “PRO” b'linka bajda.
English: NAME OF THE MEDICINAL PRODUCT PROCYSBI 25 mg gastro-resistant hard capsules cysteamine
Maltese: TAL-PRODOTT MEDIĊINALI PROCYSBI 25 mg kapsuli ibsin gastro-reżistenti cysteamine
English: Uncommon: Hair colour changes, skin striae, skin fragility (molluscoid pseudotumour on elbows)
Maltese: Mhux komuni: Bidliet fil-kulur tax-xagħar, marki ta' ġbid fil-ġilda, fraġilità tal-ġilda (pseudotumur molluskojdi fuq il-minkbejn)
English: Specific studies with cysteamine did not show any mutagenic effects in the Ames test or any clastogenic effect in the mouse micronucleus test. A bacterial reverse mutation assay study (“Ames test”) was performed with the cysteamine bitartrate used for PROCYSBI and cysteamine bitartrate did not show any mutagenic effects in this test.
Maltese: Sar studju ta' assaġġ tal-mutazzjoni maqluba batterjali (“test ta' Ames”) bil-bitartrat taċcysteamine użat għal PROCYSBI u l-bitartrat taċ-cysteamine ma wera l-ebda effett mutaġeniku f'dan it-test.