FrancophonIA/ELRC3.0 huggingface dataset:
English: An evaluation of all data generated in the study showed that for all four symptoms statistically significant more patients responded to pentosan polysulfate sodium treatment compared to placebo:
Maltese: Evalwazzjoni tad-data kollha ġġenerata fl-istudju wriet li għall-erba' sintomi kollha li kienu sinifikanti statistikament, kien hemm aktar pazjenti li rrispondew għal kura b'pentosan polysulfate sodium meta mqabbel mal-plaċebo:
English: Responders based on patients self-evaluation of overall improvement Responders based on investigators evaluation of overall improvement Responders regarding pain and urgency Pain (moderate/50% improvement) Pain scale (1-point improvement) Pressure to urinate (moderate/50% improvement) Urgency scale (1-point improvement)
Maltese: Dawk li rrispondew rigward l-uġigħ u l-urġenza Uġigħ (titjib moderat/ta' 50 %) Skala ta' uġigħ (titjib ta' punt 1) Pressjoni biex jgħaddu l-awrina (titjib moderat/50 %) Skala ta' urġenza (titjib ta' punt 1)
English: PHARMACEUTICAL FORM
Maltese: Grupp farmakoterapewtiku:
English: Back pain Uncommon Myalgia, Arthralgia
Maltese: Uġigħ fid-dahar Mhux komuni Majalġja, artralġja
English: The potential relatedness between these adverse events and the treatment with pentosan polysulfate sodium was not discussed in the respective publications.
Maltese: Ir-relazzjoni potenzjali bejn dawn l-avvenimenti avversi u l-kura b'pentosan polysulfate sodium ma ġietx diskussa fil-pubblikazzjonijiet rispettivi.
English: The patients in both studies were treated for three months with either 3x100 mg pentosan polysulfate sodium or placebo.
Maltese: Il-pazjenti fiż-żewġ studji ġew ikkurati għal tliet xhur b'jew 3x100 mg pentosan polysulfate sodium jew bil-plaċebo.
English: No. randomized
Maltese: Użu orali
English: Patients who have a history of heparin or pentosan polysulfate sodium induced thrombocytopenia should be carefully monitored when treated with pentosan polysulfate sodium.
Maltese: Il-pazjenti li għandhom storja ta' tromboċitopenja indotta minn eparina jew pentosan polysulfate sodium għandhom jiġu mmonitorjati b'attenzjoni meta jiġu kkurati b'pentosan polysulfate sodium.
English: • allergic to pentosan polysulfate sodium or any of the other ingredients of this medicine (listed in section 6)
Maltese: • jekk inti allerġiku għal pentosan polysulfate sodium jew għal xi sustanza oħra ta' din il mediċina (elenkata fis-sezzjoni 6)
English: EU/1/17/1189/001 EU/1/17/1189/002
Maltese: FIS-SUQ EU/1/17/1189/002
English: QUALITATIVE AND QUANTITATIVE COMPOSITION
Maltese: 2. GĦAMLA KWALITATTIVA
English: Changes from baseline voiding characteristics Mean volume per void (cc)
Maltese: Volum medju għal kull tbattil (cc)
English: The GRA assessment was evaluated via a 7-point centred scale, in which the patients can assess their global response compared to baseline as markedly worse, moderately worse, slightly worse, no change, slightly improved, moderately improved or markedly improved.
Maltese: Il-valutazzjoni GRA ġiet evalwata permezz ta' skala ċċentrata fuq 7 punti, li fiha l-pazjenti jistgħu jivvalutaw ir-rispons globali tagħhom meta mqabbel mal-linja bażi bħala agħar b'mod sinifikanti, agħar b'mod moderat, ftit agħar, l-ebda bidla, ftit aħjar, aħjar b'mod moderat jew aħjar b'mod sinifikanti.
English: Liver function abnormalities
Maltese: Mhux magħruf Anormalitajiet fil-funzjoni tal-fwied
English: A responder analysis based on a patientreported Global Response Assessment (GRA) after 24 weeks of treatment was defined as primary endpoint.
Maltese: Analiżi ta' dawk li rrispondew ibbażata fuq Valutazzjoni ta' Rispons Globali (GRA, Global Response Assessment) irrappurtata mill-pazjenti wara 24 ġimgħa ta' kura ġiet definita bħal punt aħħari primarju.
English: Uncommon Dyspnoea
Maltese: Frekwenza tal-awrina
English: What elmiron looks like and contents of the pack
Maltese: Kif jidher elmiron u l-kontenut tal-pakkett
English: • mouth ulcer
Maltese: • ulċeri fil-ħalq
English: What is in this leaflet
Maltese: Indiċi medju ta' problemi
English: Coagulation disorders
Maltese: Ċelluloża mikrokristallina
English: A pooled analysis of the data described above from placebo-controlled clinical studies was conducted to evaluate, whether patients taking oral pentosane polysulfate sodium have clear benefit from the treatment.
Maltese: Analiżi miġbura tad-data deskritta hawn fuq minn studji kliniċi kkontrollati bil-plaċebo twettqet biex jiġi evalwat jekk il-pazjenti li jieħdu pentosan polysulfate sodium orali għandhomx benefiċċju ċar mill-kura.
English: • allergic reactions, increased sensitivity to light
Maltese: • reazzjonijiet allerġiċi, sensittività miżjuda għad-dawl
English: The non-inferiority margin was 15 cm/s.
Maltese: noninferjorità kien 15 cm/s.
English: Parvovirus B19 infection
Maltese: Infezzjoni parvovirus B19
English: Suite 2, Stafford House Strand Road Portmarnock Co. Dublin
Maltese: Suite 2, Stafford House Strand Road Portmarnock Co.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/19/1366/001
Maltese: EU/1/19/1366/001
English: Haemoglobin (Hb) (g/dL)
Maltese: Emoglobina (Hb) (g/dL)
English: Nova Laboratories Ireland Limited
Maltese: Nova Laboratories Ireland Limited 3rd Floor
English: WBC (×109/L) HbF (%) Reticulocytes (%)
Maltese: WBC (×109/L) HbF (%)
English: Number of events / patient/ year
Maltese: avvenimenti / pazjent/ sena
English: Mean corpuscular haemoglobin concentration (MCHC) (%)
Maltese: Konċentrazzjoni tal emoglobina korpuskolari medja (MCHC) (%)
English: Amenorrhea
Maltese: Amenorrea
English: Severe renal impairment (CrCl < 30 ml/min).
Maltese: Indeboliment tal-kliewi sever (CrCl < 30 ml/min).
English: Weight gain, vitamin D deficiency
Maltese: Żieda fil-piż, defiċjenza tal vitamina D
English: -9.60 (95% CI -10.86 to -8.34) (p < 0.00001).
Maltese: 86 sa -8.34) (p < 0.00001).
English: Platelets (×109/L)
Maltese: Pjastrini (×109/L)
English: Ulysses House Foley Street, Dublin 1 D01 W2T2
Maltese: Foley Street, Dublin 1
English: Severe hepatic impairment (Child-Pugh classification C).
Maltese: Indeboliment tal-fwied sever (klassifikazzjoni Child-Pugh C).
English: The respective value in children was similar, 0.22 L/h/kg.
Maltese: Il-valur rispettiv fit-tfal kien simili, 0.22 L/h/kg.
English: Open date: __________
Maltese: Data meta nfetaħ: __________
English: Thrombocytopenia, anaemia
Maltese: Tromboċitopenja, anemija
English: A total of 299 participants were randomised; 152 to hydroxycarbamide and 147 to matching placebo.
Maltese: Ġew randomizzati total ta' 299 parteċipant; 152 għal hydroxycarbamide u 147 għal plaċebo li jaqbel.
English: Oligospermia, azoospermia
Maltese: Oligospermja, ażoospermja
English: Placebo (n=22)
Maltese: (n=22)
English: Open date: ______
Maltese: Data meta nfetaħ: ______
English: Oral use.
Maltese: Soluzzjoni orali.
English: Rarely leg ulcers and very rarely systemic lupus erythematosus have been reported.
Maltese: F'każijiet rari, ġew irrappurtati ulċeri tarriġlejn u lupus erythematosus sistematiku rari ħafna.
English: 0.25 ml contains 25 mg of hydroxycarbamide).
Maltese: 0.25 ml fiha 25 mg ta' hydroxycarbamide).
English: Evidence for the efficacy of hydroxycarbamide in reducing the vaso-occlusive complications of Sickle Cell Disease in patients older than 2 years comes from four randomised controlled trials (Charache et al 1995 [MSH Study]; Jain et al 2012, Ferster et al 1996; Ware et al 2015 [TWiTCH]).
Maltese: Evidenza għall-effikaċja ta' hydroxycarbamide fit-tnaqqis tal-kumplikazzjonijiet vażookklużivi talMarda tas-Sickle Cell f'pazjenti li għandhom iktar minn sentejn tiġi minn erba' provi randomizzati kkontrollati (Charache et al 1995 [MSH Study]; Jain et al 2012, Ferster et al 1996;
English: - Bleeding Reporting of side effects
Maltese: Fsada Rappurtar tal-effetti sekondarji
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu
Maltese: Mediċini http://www.ema.europa.eu/.
English: P value1
Maltese: Valur p1
English: Bone marrow depression including neutropenia, reticulocytopenia, macrocytosis
Maltese: Depressjoni tal-mudullun inklużi newtropenja, retikuloċitopenja, makroċitożi
English: Strawberry flavour Methyl parahydroxybenzoate (E218) Sodium hydroxide (E524) Purified water
Maltese: Methyl parahydroxybenzoate (E218) Sodium hydroxide (E524)
English: Wigston, Leicester LE18 4YL
Maltese: Nova Laboratories Limited Martin House Gloucester Crescent Wigston, Leicester LE18 4YL
English: NAME OF THE MEDICINAL PRODUCT Xromi 100 mg/ml oral solution hydroxycarbamide
Maltese: Xromi 100 mg/ml soluzzjoni orali hydroxycarbamide
English: Hydroxycarbamide at 30, 100 and 300 µM is not metabolised in vitro by cytochrome P450s of human liver microsomes.
Maltese: Hydroxycarbamide fi 30, 100 u 300 µM mhuwiex metabolizzat in vitro minn ċitokromu P450s ta' mikrożomi tal-fwied tal-bniedem.
English: NAME OF THE MEDICINAL PRODUCT Xromi 100 mg/ml oral solution
Maltese: Xromi 100 mg/ml soluzzjoni orali
English: Gastrointestinal disturbances, gastrointestinal ulcer, severe hypomagnesaemia
Maltese: ulċeri gastrointestinali, ipomanjeżemija severa
English: 2 years.
Maltese: 3 xhur.
English: Hydroxycarbamide was administered at an initial dose of 20 mg/kg/day.
Maltese: Hydroxycarbamide ngħata b'doża inizjali ta' 20 mg/kg/jum.
English: (listed in section 6).
Maltese: (ara sezzjoni 4.4).
English: Gastrointestinal disorders
Maltese: Disturbi gastrointestinali,
English: Table 3: Mean Haematologic Values Before and After 6 Months of Treatment with hydroxycarbamide (Ferster et al, 1996)
Maltese: Kura ta' 6 Xhur b'hydroxycarbamide (Ferster et al, 1996)
English: Multi-centre study of hydroxycarbamide in Sickle Cell Anaemia (MSH) The MSH study was a multicentre, randomised, and double-blind study, which compared hydroxycarbamide with placebo in adults with Sickle Cell Anaemia (HbSS genotype only) with the objective of reducing the frequency of pain crises.
Maltese: Studju multiċentriku ta' hydroxycarbamide fl-Anemija tas-Sickle Cell (MSH) L-istudju MSH kien studju multiċentriku, randomizzat u double-blind, li qabbel hydroxycarbamide mal-plaċebo f'adulti b'Anemija tas-Sickle Cell (ġenotip HbSS biss) bil-għan li titnaqqas il-frekwenza tal-kriżijiet tal-uġigħ.
English: Low fixed dose hydroxycarbamide in children with Sickle Cell Disease (Jain et al 2012)
Maltese: Doża baxxa fissa ta' hydroxycarbamide fit-tfal bil-Marda tas-Sickle Cell (Jain et al 2012)
English: Final model-based TCD velocities were 143 cm/s (95% CI 140-146) in children who received standard transfusions and 138 cm/s (95% CI 135-142) in those who received hydroxycarbamide, with a difference of 4.54 cm/s (95% CI 0.10-8.98).
Maltese: Il-veloċitajiet ta' TCD finali abbażi ta' mudell kienu 143 cm/s (95% CI 140-146) fi tfal li rċivew trasfużjonijiet standard u 138 cm/s (95% CI 135-142) f'dawk li rċivew hydroxycarbamide, b'differenza ta' 4.54 cm/s (95% CI 0.10-8.98).
English: In adults without swallowing difficulties, solid oral formulations may be more appropriate and convenient.
Maltese: F'adulti mingħajr diffikultajiet ta' bligħ, formulazzjonijiet orali solidi jistgħu jkunu aktar xierqa u konvenjenti.
English: The other ingredients are xanthan gum, sucralose (E955), strawberry flavour, methyl parahydroxybenzoate (E218), sodium hydroxide, and purified water.
Maltese: Is-sustanzi mhux attivi l-oħra huma xanthan gum, sucralose (E955), togħma ta' frawli, methyl parahydroxybenzoate (E218), sodium hydroxide, u ilma ppurifikat.
English: In adults, the urinary recovery of unchanged drug is reported to be approximately 37% of the oral dose when renal function is normal.
Maltese: Fl-adulti, l-irkupru tal-awrina ta' mediċina mhux mibdula huwa rrappurtat li huwa bejn wieħed u ieħor 37 % tad-doża orali meta l-funzjoni tal-kliewi tkun normali.
English: LIST OF EXCIPIENTS Also contains: methyl parahydroxybenzoate (E218).
Maltese: Fih ukoll: methyl parahydroxybenzoate (E218).
English: Studies have shown that there is an analytical interference of hydroxycarbamide with the enzymes (urease, uricase, and lactic dehydrogenase) used in the determination of urea, uric acid, and lactic acid, rendering falsely elevated results of these in patients treated with hydroxycarbamide.
Maltese: Studji wrew li hemm interferenza analitika ta' hydroxycarbamide mal-enżimi (urease, uricase, u lactic dehydrogenase) użati fid-determinazzjoni ta' urea, uric acid, u lactic acid, li jirrendu riżultati elevati b'mod falz ta' dawn f'pazjenti kkurati b'hydroxycarbamide.
English: Tabulated list of adverse reactions
Maltese: Tabella 1: Reazzjonijiet avversi
English: Patients with normal (CrCl> 90 ml/min), mild (CrCl 60-89 ml/min), moderate (CrCl 3059 ml/min), severe (CrCl 15-29 ml/min) renal impairment, and End Stage Renal Disease (CrCL < 15 ml/min) received hydroxycarbamide as a single dose of 15 mg/kg body weight.
Maltese: Pazjenti b'indeboliment tal-kliewi normali (CrCl> 90 ml/min), ħafif (CrCl 60-89 ml/min), moderat (CrCl 30-59 ml/min), sever (CrCl 15-29 ml/min), au
English: Skin ulcer, oral, nail and skin hyperpigmentation, dry skin, alopecia
Maltese: iperpigmentazzjoni orali, taddwiefer u tal-ġilda, ġilda niexfa, alopeċja
English: The list is presented by system organ class, MedDRA preferred term, and frequency using the following frequency categories: very common (≥ 1/10), common (≥ 1/100, < 1/10), uncommon (≥
Maltese: ‑sistem a tal‑ klassifika tal‑ organi, it u l-frekwenza permezz tal-kategoriji ta' frekwenza li ġejjin: komuni ħafna (≥ 1/10), komuni (≥ 1/100, < 1/10), mhux komuni (≥ 1/1,000, < 1/100), rari (≥ 1/10,000, < 1/1,000), rari ħafna (< 1/10,000), u mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: Fever
Maltese: Fsada
English: (each graduation of 0.1 ml contains 10 mg of hydroxycarbamide).
Maltese: (kull gradwazzjoni ta' 0.1 ml fiha 10 mg ta' hydroxycarbamide).
English: Hydroxycarbamide is an orally active antineoplastic agent.
Maltese: Hydroxycarbamide huwa aġent antineoplastiku attiv b'mod orali.
English: At concentrations ranging from 10 to 300 µM, hydroxycarbamide does not stimulate the in vitro ATPase activity of recombinant human P glycoprotein (P-gp), indicating that hydroxycarbamide is not a P-gp substrate.
Maltese: F'konċentrazzjonijiet li jvarjaw minn 10 sa 300 µM, hydroxybamide ma jistimulax l-attività in vitro ta' ATPase tal-glikoproteina P rikombinanti tal-bniedem (P-gp), li jindika li hydroxycarbamide mhuwiex substrat ta' P-gp.
English: Systemic and cutaneous lupus erythematosus
Maltese: Lupus erythematosus sistemiku u tal-ġilda
English: Pharmacotherapeutic group: Antineoplastic agents, other antineoplastic agents, ATC code: L01XX05.
Maltese: Aġenti antineoplastiċi, aġenti neoplastiċi oħra, Kodiċi ATC:
English: Headache, dizziness
Maltese: Stomatite, dijarea, rimettar
English: The maximum dose is 35 mg/kg/day.
Maltese: Id-doża massima hija ta' 35 mg/kg/jum.
English: Fatal hepatic events were reported most often in patients treated with the combination of hydroxycarbamide, didanosine, and stavudine.
Maltese: Avvenimenti epatiċi fatali ġew irrappurtati l-aktar ta' spiss f'pazjenti kkurati bil-kombinazzjoni ta' hydroxycarbamide, didanosine, u stavudine.
English: The macrocytosis may mask the incidental development of folic acid deficiency; regular determinations of serum folic acid are recommended.
Maltese: Il-makroċitożi tista' taħbi l-iżvilupp inċidentali ta' defiċjenza ta' folic acid, huma rakkomandati determinazzjonijiet regolari ta' folic acid fis-seru.
English: Hydroxycarbamide is cytotoxic.
Maltese: Hydroxycarbamide huwa ċitotossiku.
English: There was also significant difference between the hydroxycarbamide group and placebo groups in the number of blood transfusions, mean difference -1.85 (95% CI -2.18 to -1.52) (p < 0.00001), in the number of hospitalisations, mean difference -8.89 (95% CI -10.04 to -7.74) (p < 0.00001), and the duration of hospitalisation, mean difference -4.00 days (95% CI -4.87 to -3.13) (p < 0.00001).
Maltese: Kien hemm ukoll differenza sinifikanti bejn il-grupp ta' hydroxycarbamide u l-gruppi tal-plaċebo fl-għadd ta' trasfużjonijiet tad-demm, differenza medja -1.85 (95% CI -2.18 sa -1.52) (p < 0.00001), fl-għadd ta' nies li jiddaħħlu l-isptar, differenza medja -8.89 (95% CI -10.04 sa -7.74) (p < 0.00001), u t-tul taż-żmien l-isptar, differenza medja -4.00 ijiem (95% CI -4.87 sa -3.13) (p < 0.00001).
English: Hydroxycarbamide is presumed to be a transspecies carcinogen (see section 5.3).
Maltese: Hydroxycarbamide huwa preżunt li huwa karċinoġenu transspeċi (ara sezzjoni 5.3).
English: It is recommended that the starting dose is reduced by 50% in patients with CrCl <60 ml/min (see sections 4.2 and 4.3).
Maltese: Huwa rakkomandat li d-doża tal-bidu titnaqqas b'50 % f'pazjenti b'CrCl <60 ml/min (ara sezzjonijiet 4.2 u 4.3).
English: Hydroxycarbamide crosses the placental barrier, demonstrated by dams exposed to hydroxycarbamide during gestation.
Maltese: Hydroxycarbamide jaqsam il-barriera tal-plaċenta, li jintwera mid-digi esposti għal hydroxycarbamide matul il-ġestazzjoni.
English: Peripheral neuropathy, which was severe in some cases, has been reported in HIV-infected patients receiving hydroxycarbamide in combination with anti-retroviral medicinal products, including didanosine, with or without stavudine (see section 4.4).
Maltese: Newropatija periferali, li f'xi każijiet kienet severa, ġiet irrappurtata f'pazjenti infettati bl-HIV li rċivew hydroxycarbamide flimkien ma' prodotti mediċinali antiretrovirali, inkluż didanosine, ma' jew mingħajr without (ara sezzjoni 4.4).
English: In patients with Sickle Cell Disease, neutropenia was reported in isolated cases of hydroxycarbamide overdose (1.43 times and 8.57 times of the maximum recommended dose of 35 mg/kg body weight/ day).
Maltese: F'pazjenti bil-Marda tas-Sickle Cell, ġiet irrappurtata newtropenja f'każijiet iżolati ta' doża eċċessiva ta' hydroxycarbamide (1.43 darbiet u 8.57 darbiet tad-doża massima rakkomandata ta' 35 mg/kg tal piż tal-ġisem/jum).
English: Table 2: Number of Hospitalisations and Number of Days in Hospital by Treatment (Both Periods Combined)(Ferster et al, 1996)
Maltese: Kkombinati) (Ferster et al, 1996)
English: Hydroxycarbamide may produce bone marrow suppression; leukopenia is generally its first and most common manifestation.
Maltese: Hydroxycarbamide jista' jipproduċi soppressjoni tal-mudullun; lewkopenja ġeneralment hija l-ewwel u l-aktar manifestazzjoni komuni.
English: Impaired fertility has been observed in male rats (see section 5.3).
Maltese: Ġiet osservata fertilità indebolita fil-firien irġiel (ara sezzjoni 5.3).
English: In addition, there was a reduction in mean hospital stay; 5.3 days in the hydroxycarbamide group and 15.2 days in the placebo group.
Maltese: 5.3 jiem fil-grupp ta' hydroxycarbamide u 15.2 jiem fil-grupp tal-plaċebo.
English: In keeping with the mechanism of action of hydroxycarbamide, the MSH study also showed a statistically significant increase in HbF (mean difference 3.9% (95% CI 2.69 to 5.11 (p < 0.0001)) and haemoglobin levels (mean difference 0.6 g/dL (95% CI 0.28 to 0.92, p < 0.0014) and a decrease in haemolytic markers in the groups treated with hydroxycarbamide.
Maltese: F'konformità mal-mekkaniżmu ta' azzjoni ta' hydroxycarbamide, l-istudju tal-MSH wera wkoll żieda statistikament sinifikanti fl-HbF (differenza medja 3.9 % (95 % CI 2.69 sa 5.11 (p < 0.0001)) u fil livelli tal-emoglobina (differenza medja 0.6 g/dL (95 % CI 0.28 sa 0.92, p < 0.0014) u tnaqqis filmarkaturi emolitiċi fil-gruppi kkurati b'hydroxycarbamide.
English: One ml of solution contains 100 mg of hydroxycarbamide.
Maltese: Kull ml tas-soluzzjoni fih 100 mg hydroxycarbamide.
English: The recovery from myelosuppression is rapid when hydroxycarbamide therapy is interrupted.
Maltese: L-irkupru minn majelosuppressjoni huwa rapidu meta tiġi interrotta t-terapija b'hydroxycarbamide.
English: Bottle
Maltese: Qabel
English: The largest difference in the pharmacokinetic profile was a trend towards a shorter time to peak concentration following ingestion of the liquid compared with the capsule, but that difference did not reach statistical significance (0.74 versus 0.97 hours, p = 0.14).
Maltese: L-akbar differenza fil-profil farmakokinetiku kienet xejra lejn żmien iqsar għall-konċentrazzjoni massima wara l-inġestjoni tallikwidu mqabbel mal-kapsula, iżda dik id-differenza ma laħqitx sinifikanza statistika (0.74 kontra 0.97 sigħat, p = 0.14).
English: Gradual dose titration is recommended to avoid more severe bone marrow suppressions (see section 4.2).
Maltese: Titrazzjoni b'doża gradwali hija rrakkomandata biex jiġu evitati suppressjonijiet aktar severi tal-mudullun (ara sezzjoni 4.2).
English: It is important that you use the correct dosing syringe for your medicine.
Maltese: Huwa importanti li jiġu rrappurtati reazzjonijiet avversi suspettati wara l-awtorizzazzjoni tal-prodott mediċinali.
English: The digital distribution of these vasculitic ulcerations and progressive clinical behaviour of peripheral vasculitic insufficiency leading to digital infarct or gangrene were distinctly different than the typical skin ulcers generally described with Hydroxycarbamide.
Maltese: Id-distribuzzjoni diġitali ta' dawn l-ulċerazzjonijiet vaskulitiċi u l-imġiba klinika progressiva tal-insuffiċjenza vaskulattiva periferali li twassal għal infart jew gangrene diġitali kienet distintivament differenti millulċeri tal-ġilda tipiċi deskritti b'mod ġenerali b'Hydroxycarbamide.
English: Teratogenic effects manifested as partially ossified cranial bones, absence of eye sockets, hydrocephaly, bipartite sternebrae, and missing lumbar vertebrae.
Maltese: L-effetti teratoġeniċi li dehru bħala għadam kranjali parzjalment mgħaddra, nuqqas ta' sokits tal-għajnejn, idroċefalija, bipartite sternebrae, u vertebri lumbari neqsin.
English: Hydroxycarbamide must not be administered to patients with severe renal impairment (CrCl < 30 ml/min) (see sections 4.3, 4.4, and 5.2).
Maltese: < 30 ml/min) (ara sezzjonijiet 4.3, 4.4, u 5.2).
English: Red blood cell (RBC), mean cell volume (MCV), and foetal haemoglobin (HbF) levels should be monitored for evidence of consistent or progressive laboratory response.
Maltese: Il-livelli taċ-ċellula ħamra tad-demm (red blood cell, RBC), tal-volum medju taċ-ċelluli (mean cell volume, MCV), u tal-emoglobina fil-fetu (foetal haemoglobin, HbF) għandhom jiġu mmonitorjati għal evidenza ta' rispons konsistenti jew progressiv tal-laboratorju.
English: stavudine, and indinavir (a drop in your white cell count may occur) - live vaccines, e.g. measles, mumps, rubella (MMR), chicken pox
Maltese: stavudine, u indinavir (jista' jseħħ tnaqqis fl-għadd ta' ċelluli bojod tiegħek) - vaċċini ħajjin, eż. ħosba, gattone, rubella (MMR), ġidri r-riħ
English: There was a statistically significant reduction in time to peak concentration with hydroxycarbamide oral solution compared to the reference 500 mg capsule (0.5 versus 0.75 hours, p = 0.0467), indicating a faster rate of absorption.
Maltese: Kien hemm tnaqqis statistikament sinifikanti fil-ħin għal konċentrazzjoni massima b'hydroxycarbamide soluzzjoni orali meta mqabbel mal-kapsula ta' referenza ta' 500 mg (0.5 kontra 0.75 sigħat, p =
English: Hepatotoxicity and hepatic failure resulting in death were reported during post-marketing surveillance in HIV-infected patients treated with hydroxycarbamide and other antiretroviral medicinal products.
Maltese: wara t-tqegħid fis-suq f'pazjenti infettati bl-HIV li ġew ikkurati b'hydroxycarbamide u prodotti mediċinali antiretrovirali oħrajn.
English: Non-inferiority (p = 8.82×10-16) and post-hoc superiority (p = 0.023) were met.
Maltese: Ġew issodisfati n-noninferjorità (p = 8.82×10-16) u s-superjorità post-hoc (p = 0.023). Ma kienx hemm differenza f'avvenimenti newroloġiċi ta' periklu għall-ħajja bejn il-gruppi ta' kura.
English: The usual starting dose of hydroxycarbamide is 15 mg/kg/day and usual maintenance dose is between 20-25 mg/kg.
Maltese: Id-doża tal-bidu tas-soltu ta' hydroxycarbamide hija 15 mg/kg/jum u d-doża normali tal-manteniment hija bejn 20-25 mg/kg.
English: Table 4: Comparison of the Number of Clinical Events before and after Intervention in the Hydroxycarbamide and Placebo Groups
Maltese: Tabella 4: Paragun tan-Numru ta' Avvenimenti Kliniċi qabel u wara