FrancophonIA/ELRC3.0 huggingface dataset:
English: 3 ml and 12 ml dosing syringes.
Maltese: Adapter tal-flixkun Siringi tad-dożaġġ ta' 3 ml u 12 ml.
English: Other medicines and Xromi
Maltese: INFORMAZZJONI BIL-BRAILLE Xromi
English: In patients with a creatinine clearance (CrCl) ≤ 60 ml/min the initial hydroxycarbamide dose should be decreased by 50%.
Maltese: F'pazjenti bi tneħħija talkreatinina (CrCl) ≤ 60 ml/min id-doża inizjali ta' hydroxycarbamide għandha titnaqqas b'50 %.
English: Xromi contains methyl parahydroxybenzoate (E218) Xromi contains methyl parahydroxybenzoate (E218) which may cause allergic reactions (possibly delayed).
Maltese: Dan il-prodott mediċinali fih methyl parahydroxybenzoate (E218) li jista' jikkawża reazzjonijiet allerġiċi (possibbilment ittardjati).
English: Cutaneous vasculitic toxicities
Maltese: GĦAMLA FARMAĊEWTIKA
English: NHLBI-funded Phase III multicenter, randomized clinical trial comparing 24 months of standard treatment (monthly blood transfusions) to alternative treatment (hydroxycarbamide) in 121 children aged 4-16 years with Sickle Cell Disease and abnormal TCD velocities (≥ 200 cm/s) who had received at least 12 months of chronic transfusions and did not have severe vasculopathy, documented clinical stroke, or transient ischaemic attack..
Maltese: f'121 tifel u tifla ta' età bejn 4-16-il sena bil-Marda tas-Sickle Cell u veloċitajiet ta' TCD anormali (≥ 200 cm/s) li kienu rċivew mill-inqas 12-il xahar ta' trasfużjonijiet kroniċi u ma kellhomx vavaspatija severa, puplesija klinika ddokumentata, jew attakk iskemiku temporanju.
English: ‘EXP'.
Maltese: Għadd ta'
English: It appears that nitroxyl, the corresponding carboxylic acid and nitric oxide are metabolites: Urea has also been shown to be a metabolite of hydroxycarbamide.
Maltese: Jidher linitroxyl, carboxylic acid korrispondenti u nitric oxide huma metaboliti:
English: Oligospermia and azoospermia caused by hydroxycarbamide are in general reversible, but have to be taken into account when fatherhood is desired (see section 5.3).
Maltese: Oligospermja u ażoospermja kkawżati minn hydroxycarbamide huma riversibbli b'mod ġenerali, iżda għandhom jitqiesu meta tkun mixtieqa l-paternità (ara sezzjoni 5.3).
English: See section 2 “Xromi contains methyl parahydroxybenzoate”.
Maltese: Ara sezzjoni 2 “Xromi fih methyl parahydroxybenzoate”.
English: Severe anaemia must be corrected with whole blood replacement before initiating therapy with hydroxycarbamide.
Maltese: L-anemija severa għandha tiġi kkoreġuta bis-sostituzzjoni sħiħa tad-demm qabel tinbeda t-terapija b'hydroxycarbamide.
English: Iron overload improved more in the hydroxycarbamide than the transfusion arm, with a greater average change in serum ferritin (-1805 versus -38 ng/mL; p < 0.0001) and liver iron concentration (average = -1.9 mg/g versus +2.4 mg/g dry weight liver; p = 0.0011).
Maltese: It-tagħbija eċċessiva tal-ħadid tjeibet aktar fil-fergħa ta' hydroxycarbamide milli f'tat-trasfużjoni, b'bidla medja ikbar fil-ferritin fis-seru (-1805 kontra -38 ng/mL; p < 0.0001) u konċentrazzjoni tal-ħadid fil-fwied (medja = -1.9 mg/g kontra +2.4
English: Toxic ranges of myelosuppression as described in section 4.2.
Maltese: Meded tossiċi ta' majelosuppressjoni kif deskritt f'sezzjoni 4.2.
English: An increase in HbF and a decrease in absolute neutrophil count were reported in the hydroxycarbamide group.
Maltese: Żieda fl-HbF u tnaqqis fl-għadd assolut ta' newtrofili ġew irrappurtati fil grupp ta' hydroxycarbamide.
English: How to take Xromi
Maltese: X'fih Xromi
English: Concomitant anti-retroviral medicinal products for HIV disease (see sections 4.4 and 4.5)
Maltese: Tqala (ara sezzjoni 4.6) Prodotti mediċinali konkomitanti antiretrovirali għall-marda tal-HIV (ara sezzjonijiet 4.4 u 4.5)
English: Xromi
Maltese: Rimi
English: Hepatic impairment
Maltese: Immaniġġar sigur
English: Hydroxycarbamide may cause hepatotoxicity and liver function tests should be monitored during treatment.
Maltese: Hydroxycarbamide jista' jikkawża epatotossiċità u waqt il-kura għandhom jiġu mmonitorjati testijiet tal-funzjoni tal-fwied.
English: Xromi is for oral use.
Maltese: Xromi huwa għal użu orali.
English: The Guide for healthcare professionals shall contain the following key elements: - Indication, dosage and dose adjustment; - Description of safe handling of Xromi, including the risk of medication error due to the use of two different dosing syringes; - Warnings about important risks associated with using Xromi: o Switching patients from capsule and tablet to liquid formulation; o Haematological toxicity, use of other myelosuppressive agent or radiation therapy; o Concomitant use of nucleoside analogue reverse transcriptase inhibitors; o Skin ulceration and vasculitis, leg ulcers; o Long-term safety, in particular the development of malignancies (leukaemia, skin cancer); o Teratogenicity and male fertility; Need for contraception; Breast feeding; o Adverse drug reactions most frequently reported; - Follow-up of patients treated with Xromi: o Haematological follow-up and dose adjustment; o Follow-up of patients with renal and/or hepatic impairment; o Growth follow-up in children;
Maltese: L-embrijotossiċità li dehret bħala tnaqqis fil-vijabbiltà tal-fetu, tnaqqis fiddaqsijiet ta' frieħ ħajjin, u dewmien fl-iżvilupp ġiet irrappurtata fi speċijiet inkluż ġrieden, ħamsters, qtates, klieb, u xadini f'dożi komparabbli ma' dożi tal-bniedem.
English: Use in elderly
Maltese: U L-UŻU
English: In patients receiving long-term therapy with hydroxycarbamide for myeloproliferative disorders, such as polycythemia, secondary leukaemia has been reported.
Maltese: Fil-pazjenti li rċevew terapija fit-tul b'hydroxycarbamide għal disturbi mijeloproliferattivi, bħal poliċitemija, ġiet irrappurtata lewkimja sekondarja.
English: P value2 Vaso-occlusive crises 12.13 ± 8.56 0.6 ± 1.37 11.46 ± 3.01 10.2 ± 3.24 0.10 <0.001 Blood transfusions 2.43 ± 0.69 0.13 ± 0.43 2.13 ± 0.98 1.98 ± 0.82 0.25 <0.001 Hospitalisations P value is for comparison between hydroxycarbamide and placebo groups at baseline P value is for comparison between hydroxycarbamide and placebo groups at 18 months Primary stroke prevention (TWiTCH study) Transcranial Doppler (TCD) with Transfusions Changing to Hydroxycarbamide (TWiTCH) was an
Maltese: L-istudju wera wkoll żieda fiż-żmien medjan mill-bidu tal-kura sal-ewwel kriżi ta' uġigħ (2.76 xahar fil-fergħa ta' hydroxycarbamide meta mqabbel ma' 1.35 xhur fuq il-plaċebo (p = 0.014), it-tieni kriżi ta' uġigħ (6.58 xhur fil-grupp ta' hydroxycarbamide meta mqabbel ma' 4.13 xhur fuq il-plaċebo (p < 0.0024), u t-tielet kriżi ta' uġigħ (11.9 xhur fil-grupp ta' hydroxycarbamide meta mqabbel ma' 7.04
English: Hydroxycarbamide Therapy (mean ± SD)
Maltese: Hydroxycarbamide nbeda f'doża baxxa
English: Cutaneous vasculitic toxicities including vasculitic ulcerations and gangrene have occurred in patients with myeloproliferative disorders during therapy with hydroxycarbamide.
Maltese: Seħħew tossiċitajiet vaskulitiċi tal-ġilda, inkluż ulċerazzjonijiet vaskulitiċi u gangrene, f'pazjenti b'disturbi mijeloproliferattivi waqt it-terapija b'hydroxycarbamide.
English: Your pack of Xromi contains a bottle of medicine, a cap, a bottle adaptor and two dosing syringes (a red 3 ml syringe and a white 12 ml syringe).
Maltese: Il-pakkett tiegħek ta' Xromi fih flixkun tal-mediċina, tapp, adapter tal-flixkun u żewġ siringi taddożaġġ (siringa ħamra ta' 3 ml u siringa bajda ta' 12 ml).
English: PC:
Maltese: C.
English: Leg ulcers are a common complication of Sickle Cell Disease, but have also been reported in patients treated with hydroxycarbamide.
Maltese: Ulċeri fir-riġlejn huma komplikazzjoni komuni tal-Marda tas-Sickle Cell, iżda ġew irrappurtati wkoll f'pazjenti kkurati b'hydroxycarbamide.
English: Soreness, violet erythema, oedema on palms and foot soles followed by scaling of hands and feet, intense generalised hyperpigmentation of skin, and severe acute stomatitis were observed.
Maltese: Ġew osservati sensittività, eritema vjola, edema fuq il-pali tal-id u l-qiegħ tas-sieq segwiti minn qoxra tal-idejn u tas-saqajn, iperpigmentazzjoni ġeneralizzata intensa tal-ġilda, u stomatite akuta severa.
English: Do not shake.
Maltese: Ilma ppurifikat
English: A clinical response to treatment with hydroxycarbamide may take 3-6 months and therefore, a 6month trial on the maximum tolerated dose is required prior to considering discontinuation due to treatment failure (whether due to lack of adherence or failure to respond to therapy).
Maltese: Rispons kliniku għal kura b'hydroxycarbamide jista' jieħu minn 3-6 xhur u għalhekk, hija meħtieġa prova ta' 6 xhur fuq id-doża massima ttollerata qabel ma jiġi kkunsidrat it-twaqqif minħabba falliment tal-kura (kemm jekk minħabba nuqqas ta' konformità jew minħabba nuqqas ta' rispons għat-terapija).
English: Warnings and precautions Test and checks
Maltese: Twissijiet u prekawzjonijiet Testijiet u kontrolli
English: Range
Maltese: LOTT
English: Fatal and non-fatal pancreatitis has occurred in HIV-infected patients during therapy with hydroxycarbamide and didanosine, with or without stavudine.
Maltese: Seħħet pankreatite fatali u mhux fatali f'pazjenti infettati bl-HIV waqt terapija b'hydroxycarbamide u didanosine, ma' jew mingħajr stavudine.
English: An erythema caused by radiation therapy may be aggravated by hydroxycarbamide.
Maltese: Eritema kkawżata mit-terapija bir-radjazzjoni tista' tiġi aggravata minn hydroxycarbamide.
English: Put on disposable hand gloves before handling Xromi.
Maltese: L-aktar sintomi komuni ta' doża eċċessiva bi Xromi huma:
English: Table 1: Adverse reactions System organ class
Maltese: Sistema tal-klassifika talorgani
English: The volume of distribution following oral dosing of hydroxycarbamide is approximately equal to total body water: adult values of 0.48 - 0.90 L/kg have been reported, whilst in children a population estimate of 0.7 L/kg has been reported.
Maltese: distribuzzjoni wara dożaġġ orali ta' hydroxycarbamide huwa madwar daqs l-ilma totali tal-ġisem: ġew irrappurtati valuri fl-adulti ta' 0.48 - 0.90
English: HbF from baseline after hydroxycarbamide use.
Maltese: Intwera wkoll li l-urea hija metabolit ta' hydroxycarbamide.
English: The smaller 3 ml syringe (red), marked from 0.5 ml to 3 ml, is for measuring doses of less than or equal to 3 ml.
Maltese: Is-siringa iżgħar ta' 3 ml (ħamra), immarkata minn 0.5 ml sa 3 ml, hija għall-kejl tad-dożi ta' inqas minn jew daqs 3 ml.
English: Hence, no interaction is to be expected in case of concomitant administration with substances being substrates of cytochromes P450 or P-gp.
Maltese: Għalhekk, m'għandha tkun mistennija l-ebda interazzjoni fil-każ ta' għoti konkomitanti ma' sustanzi li huma substrati ta' ċitokromi P450 jew P-gp.
English: United Kingdom
Maltese: Dublin
English: The study also showed a statistically significant increase in HbF and Hb levels and a decrease in haemolytic markers in the groups treated with hydroxycarbamide.
Maltese: L-istudju wera wkoll żieda statistikament sinifikanti fil-livelli ta' HbF u Hb u tnaqqis fil-markaturi emolitiċi fil-gruppi kkurati b'hydroxycarbamide.
English: In an open single-dose study in adult patients with Sickle Cell Disease the influence of renal function on pharmacokinetics of hydroxycarbamide was assessed.
Maltese: Fi studju b'doża waħda miftuħ f'pazjenti adulti bil-Marda tas-Sickle Cell, ġiet ivvalutata l-influwenza tal-funzjoni tal-kliewi fuq ilfarmakokinetika ta' hydroxycarbamide.
English: Thrombocytopenia and anaemia occur less often and are seldom seen without a preceding leukopenia.
Maltese: It-tromboċitopenja u l-anemija jseħħu inqas ta' spiss u rarament jidhru mingħajr lewkopenja preċedenti.
English: Hydroxycarbamide therapy can then be re-initiated at a lower dose (see section 4.2).
Maltese: It-terapija b'hydroxycarbamide tista' terġa' tinbeda mill-ġdid b'doża aktar baxxa (ara sezzjoni 4.2).
English: Recently, hydroxycarbamide has shown to be associated with the generation of nitric oxide suggesting that nitric oxide stimulates cyclic guanosine monophosphatase (cGMP) production, which then activates a protein kinase and increases the production of HbF.
Maltese: Dan l-aħħar, hydroxycarbamide wera li huwa assoċjat mal-ġenerazzjoni ta' nitric oxide li jissuġġerixxi li nitric oxide jistimula guanosine monophosphatase ċikliku (cGMP), li mbagħad jattiva proteina kinase u jżid il-produzzjoni tal-HbF.
English: Xromi is indicated for the prevention of vaso-occlusive complications of Sickle Cell Disease in patients over 2 years of age.
Maltese: Xromi huwa indikat għall-prevenzjoni ta' komplikazzjonijiet vażo-okklużivi tal-Marda tas-Sickle Cell f'pazjenti li għandhom iktar minn sentejn.
English: If, during treatment, anaemia occurs, correct without interrupting hydroxycarbamide therapy.
Maltese: Jekk, waqt it-trattament, isseħħ anemija, ikkoreġiha mingħajr ma tinterrompi t terapija b'hydroxycarbamide.
English: STATEMENT OF ACTIVE SUBSTANCE(S) One ml of solution contains 100 mg hydroxycarbamide.
Maltese: Is-sustanza attiva hi hydroxycarbamide. ml wieħed tas-soluzzjoni fih 100 mg ta' hydroxycarbamide.
English: Accidental ingestion can be lethal for children.
Maltese: mal-Awtorità Nazzjonali Kompetenti.
English: Leukaemia, skin cancers (in elderly patients)
Maltese: (lewkimja, kanċer tal-ġilda);
English: This syringe should be recommended for doses less than or equal to 3 ml (each graduation of 0.1 ml contains 10 mg of hydroxycarbamide).
Maltese: 3 ml (kull gradwazzjoni ta' 0.1 ml fiha 10 mg ta' hydroxycarbamide).
English: There was a statistically significant difference between the hydroxycarbamide group and placebo group in the mean annual crisis rate (all crises), mean difference -2.80 (95% CI -4.74 to -0.86) (p = 0.005), and for crises requiring hospitalisation, mean difference -1.50 (95% CI -2.58 to -0.42) (p = 0.007).
Maltese: Kien hemm differenza statistikament sinifikanti bejn il-grupp ta' hydroxycarbamide u l-grupp tal plaċebo fir-rata medja annwali tal-kriżi (il-kriżijiet kollha), differenza medja -2.80 (95 % CI -4.74 sa
English: Patients must not be treated with hydroxycarbamide and anti-retroviral medicinal products concurrently (see sections 4.3 and 4.4).
Maltese: Il-pazjenti m'għandhomx jiġu kkurati b'hydroxycarbamide u prodotti mediċinali antiretrovirali flistess ħin (ara sezzjonijiet 4.3 u 4.4).
English: The study reported 16 patients out of 22 (73%) did not require any hospitalisation for painful episodes when treated with hydroxycarbamide as compared with only 3 of 22 (14%) when treated with placebo.
Maltese: L-istudju rrapporta li 16-il pazjent minn 22 (73 %) ma kienu jeħtieġu l-ebda rikoveru l-isptar għal episodji ta' uġigħ meta ġew ikkurati b'hydroxycarbamide meta mqabbel ma' 3 biss minn 22 (14 %) meta ġew ikkurati bil-plaċebo.
English: After oral administration hydroxycarbamide is readily absorbed from the gastrointestinal tract.
Maltese: Wara l-għoti mill-ħalq, hydroxycarbamide jiġi assorbit faċilment mill-passaġġ gastrointestinali.
English: The physician educational material should contain:
Maltese: Il-materjal edukattiv għat-tabib għandu jkun fih:
English: Patients treated with hydroxycarbamide in combination with didanosine, stavudine, and indinavir showed a median decline in CD4 cells of approximately 100/mm3.
Maltese: Pazjenti kkurati b'hydroxycarbamide flimkien ma' didanosine, stavudine, u indinavir urew tnaqqis medjan fiċ-ċelluli CD4 ta' madwar 100/mm3.
English: Safe handling
Maltese: MANIFATTUR RESPONSABBLI
English: Parents and care givers should avoid hydroxycarbamide contact with skin or mucous membrane.
Maltese: Għandu jiġi evitat il-kuntatt ta' hydroxycarbamide mal-ġilda jew mal-membrana mukuża.
English: The usual starting dose for adults, adolescents and children over the age of 2 years is 15 mg/kg each day and the usual maintenance dose is between 20-25 mg/kg.
Maltese: manteniment tas-soltu hija ta' bejn 20-25 mg/kg.
English: Before
Maltese: Medda
English: The risk of vasculitic toxicities is increased in patients who receive prior or concomitant interferon therapy.
Maltese: Ir-riskju ta' tossiċitajiet vaskulitiċi jiżdied f'pazjenti li jirċievu terapija b' interferon preċedenti jew konkomitanti.
English: While in dogs reversible spermatogenic arrest was noted.
Maltese: Filwaqt li fi klieb, ġie nnotat arrest spermatoġeniku riversibbli.
English: Store the syringe in a hygienic place with the medicine.
Maltese: Aħżen issiringa f'post iġjeniku mal-mediċina.
English: Prior to launch of Xromi in each Member State the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Maltese: Qabel ma Xromi jitnieda f'kull Stat Membru, id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq (MAH) għandu jaqbel fuq il-kontenut u l-format tal-programm edukattiv, inkluż ilmezzi ta' komunikazzjoni, il-modalitajiet ta' distribuzzjoni, u kull aspett ieħor tal-programm,
English: Cross-over comparison with placebo (Ferster et al 1996) A randomized cross-over study was conducted in 25 children and young adults (age range: 2 to 22 years) with homozygous sickle cell anaemia and severe clinical manifestations (defined as >3 vasoocclusive crises in the year before study entry and/or with previous history of stroke, acute chest syndrome, recurrent crises without a free interval, or splenic sequestration).
Maltese: 2 u 22 sena) b'anemija tas-sickle cell omożigoża u b'manifestazzjonijiet kliniċi severi (definiti bħala > 3 kriżijiet vażookklużivi fis-sena ta' qabel id-dħul fl-istudju u/jew bi storja preċedenti ta' puplesija, sindrome tas-sider akut, kriżijiet rikorrenti mingħajr intervall liberu, jew sekwestru tal-milsa).
English: - Indication; - Instructions for proper and safe use of the product, including clear instructions on the use of two different dosing syringes to avoid the risk of medication error; - Follow-up of patients treated with Xromi: o Need for periodic blood counts; Other medicines that suppress the bone marrow and radiation therapy; o Concomitant use of anti-retroviral medicines; o Skin ulceration and vasculitis, leg ulcers; o Long-term safety, in particular the development of malignancies (leukaemia, skin cancer);
Maltese: - Deskrizzjoni tal-immaniġġjar sigur ta' Xromi, inkluż ir-riskju ta' żball fil medikazzjoni minħabba l-użu ta' żewġ siringi ta' dożaġġ differenti; - Twissijiet dwar riskji importanti assoċjati mal-użu ta' Xromi:
English: Bone marrow suppression
Maltese: Mhux sinifikanti
English: Xromi contains hydroxycarbamide, a substance which reduces the growth and multiplication of some cells in the bone marrow.
Maltese: Xromi fiha hydroxycarbamide, sustanza li tnaqqas it-tkabbir u l-multiplikazzjoni ta' xi ċelluli fil mudullun.
English: Erythrocytic abnormalities; megaloblastic erythropoiesis, which is selflimiting, is often seen early in the course of hydroxycarbamide therapy.
Maltese: Anormalitajiet eritroċitiċi; eritropojeżi megaloblastika, li tillimita lilha nnifisha, ħafna drabi tidher kmieni matul il-kors ta' t-terapija b'hydroxycarbamide.
English: Xromi can make you feel drowsy.
Maltese: Xromi ma' ikel u xorb
English: Due to safety considerations, hydroxycarbamide is contraindicated in patients with severe hepatic impairment (see sections 4.3 and
Maltese: Minħabba konsiderazzjonijiet ta' sigurtà, hydroxycarbamide huwa kontraindikat f'pazjenti b'indeboliment tal-fwied sever (ara sezzjonijiet 4.3 u 4.4).
English: Sometimes the doctor may change your dose of Xromi, for example as a result of different tests.
Maltese: Xi drabi t-tabib jista' jibdel id-doża ta' Xromi, pereżempju bħala riżultat ta' testijiet differenti.
English: The estimated volume of distribution of hydroxycarbamide approximates total body water.
Maltese: Il volum stmat ta' distribuzzjoni ta' hydroxycarbamide jqarreb l-ilma totali tal-ġisem.
English: In a comparative bioavailability study in healthy adult volunteers (n=28), 500 mg of hydroxycarbamide oral solution was demonstrated to be bioequivalent to the reference 500 mg capsule, with respect to both the peak concentration and area under the curve.
Maltese: hydroxycarbamide soluzzjoni orali intweriet li hija bijoekwivalenti għall-kapsula ta' referenza ta' 500 mg, fir-rigward ta' kemm il-konċentrazzjoni massima kif ukoll l-erja taħt il-kurva.
English: Concurrent use of hydroxycarbamide and other myelosuppressive medicinal products or radiation therapy may increase bone marrow depression, gastro-intestinal disturbances or mucositis.
Maltese: L-użu fl-istess ħin ta' hydroxykarbamide u prodotti mediċinali mijelosuppressivi jew terapija tar radjazzjoni jista' jżid id-dipressjoni tal-mudullun, id-disturbi gastrointestinali jew il-mukożite.
English: • Dose to be increased by 5 mg/kg/day increments every 8 weeks
Maltese: • Tiżdied id-doża b'5 mg/kg/jum żidiet kull 8 ġimgħat
English: You may need to read it again.
Maltese: xhur qabel it-tqala jekk ikun possibbli.
English: - other myelosuppressive medicines (those that decrease production of red, white, or coagulating blood cells) - radiation therapy or chemotherapy - any medicines for cancer treatment, especially interferon therapy - when used with Xromi there is a greater chance of side effects, such as anaemia
Maltese: Xromi hemm probabbiltà akbar ta' effetti sekondarji, bħal anemija - mediċini antiretrovirali (dawk li jinibixxu jew jeqirdu retrovirus bħall-HIV), eż. didanosine,
English: What Xromi is and what it is used for What you need to know before you take Xromi How to take Xromi
Maltese: Ilbes l-ingwanti li jintużaw darba biss qabel l-immaniġġjar ta' Xromi.
English: Each pack contains one bottle, an HDPE bottle adaptor and 2 polyethylene dosing syringes (a red syringe graduated to 3 ml and a white syringe graduated to 12 ml).
Maltese: Kull pakkett fih flixkun wieħed, adapter tal-flixkun HDPE u 2 siringi tad-dożaġġ tal-polietilen (siringa ħamra ggradwata għal 3 ml u siringa bajda ggradwata għal 12 ml).
English: BATCH NUMBER
Maltese: Numru ta' jiem flisptar
English: Very common: may affect more than 1 in 10 people - A severe infection - Fever or chills - Tiredness and/or looking pale
Maltese: Rari ħafna: jistgħu jaffettwaw sa persuna 1 minn kull 10,000 persuna - Infjammazzjoni tal-ġilda li tikkawża rqajja' ħomor bil-qoxra u possibilment flimkien ma' uġigħ fil-ġogi
English: However, a lack of increase in MCV, HbF, or both, is not an indication to discontinue therapy if the patient responds clinically (e.g. decreased incidence of pain or hospitalisation).
Maltese: Madankollu, nuqqas ta' żieda fl-MCV, fl-HbF, jew fit-tnejn li huma, mhuwiex indikazzjoni li titwaqqaf it-terapija jekk il-pazjent jirrispondi klinikament (eż. inċidenza mnaqqsa ta' uġigħ jew dħul fl-isptar).
English: Hydroxycarbamide distributes rapidly throughout the human body, enters the cerebrospinal fluid, appears in peritoneal fluid and ascites, and concentrates in leukocytes and erythrocytes.
Maltese: Distribuzzjoni Hydroxycarbamide jiddistribwixxi malajr fil-ġisem tal-bniedem kollu, jidħol fil-fluwidu ċerebrospinali, jidher fil-fluwidu peritoneali u l-axxite, u jikkonċentra fil-lewkoċiti u l-eritroċiti.
English: - Skin cancers in elderly patients - Viral infection with Parvovirus B19 - Stomach pain or heartburn - Gastrointestinal ulcer - Fever - Absence of menstrual cycles (amenorrhoea) - Weight gain
Maltese: - kwalunkwe mediċina għall-kura tal-kanċer, speċjalment terapija b'interferon - meta tintuża ma'
English: The macrocytosis caused by hydroxycarbamide is not vitamin B12 or folic acid dependent.
Maltese: B12 jew folic acid.
English: Due to potentially severe clinical outcomes for the cutaneous vasculitic ulcers reported in patients with myeloproliferative disease, hydroxycarbamide should be discontinued if cutaneous vasculitic ulcerations develop.
Maltese: F'pazjenti b'disturbi mijeloproliferattivi waqt it-terapija b'hydroxycarbamide, seħħew tossiċitajiet vaskulitiċi tal-ġilda inkluż ulċerazzjonijiet vaskulitiċi u gangrena.
English: 3rd Floor
Maltese: ANNESS III