FrancophonIA/ELRC3.0 huggingface dataset:
English: Siklos must not be administered to patients with severe renal impairment (creatinine clearance < 30 ml/min) (see sections 4.3, 4.4 and 5.2).
Maltese: Siklos m'għandux jingħata lill-pazjenti b'indeboliment renali serju (eliminazzjoni tal-krejatinina ta' < 30 ml/min) (ara sezzjoni 4.3, 4.4 u 5.2).
English: Date of first authorisation: 29/06/2007 Date of latest renewal: 24/04/2017
Maltese: Data tal-aħħar tiġdid: 24/04/2017
English: Rarely, ulcers are caused by leukocytoclastic vasculitis.
Maltese: Rarament, ulċeri jiġu kkawżati b'vaskulite lewkoċitoklastika.
English: Potentially fatal pancreatitis and hepatotoxicity, and severe peripheral neuropathy have been reported in HIV-infected patients who received hydroxycarbamide in combination with antiretroviral medicinal products, particularly didanosine plus stavudine.
Maltese: Pankreatite u epatotossiċità potenzjalment fatali, u newropatija periferali severa ġew irrappurtati f'pazjenti infettati b'HIV li ngħataw hydroxycarbamide flimkien ma' prodotti mediċinali antiretrovirali speċjalment didanosine flimkien ma' stavudine.
English: Very rare:
Maltese: Rari ħafna :
English: Other medicines and Siklos
Maltese: Mediċini oħra u Siklos
English: Siklos 100 mg film-coated tablets Pack sizes of 60, 90 or 120 tablets.
Maltese: Siklos 100 mg pilloli miksija b'rita Daqsijiet tal-pakkett ta' 60, 90 jew 120 pillola.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu.
Maltese: Ewropea għall-Mediċini http://www.ema.europa.eu.
English: Pharmacotherapeutic group: Antineoplastic agents, other antineoplastic agents, ATC code: L01XX05.
Maltese: Mediċini antineoplastiċi, aġenti antinejoplastiċi oħra, Kodiċi ATC:
English: Gastrointestinal disorders: Uncommon:
Maltese: Disturbi gastro-intestinali:
English: Urea is one metabolite of hydroxycarbamide.
Maltese: Urea hi metabolit wieħed ta' hydroxycarbamide.
English: Store below 30 °C
Maltese: Aħżen taħt 30 °C
English: In patients with Sickle Cell Syndrome, 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 b.w./day).
Maltese: F'pazjenti bis-Sindromu tas-Sickle Cells, newtropenija ġiet irrappurtata f'każijiet iżolati ta' doża eċċessiva ta' hydroxycarbamide (1.43 drabi u 8.57 drabi aktar mid-doża massima rakkomandata ta' 35 mg/kg ta' piż tal-ġisem/kuljum).
English: • Risk of medication error due to the availability of two different strengths
Maltese: • Riskju ta' żball tal-mediċina minħabba d-disponibilità ta' żewġ qawwiet differenti.
English: Store below 30°C.
Maltese: Aħżen taħt 30 °C.
English: Siklos is indicated for the prevention of recurrent painful vaso-occlusive crises including acute chest syndrome in adults, adolescents and children older than 2 years suffering from symptomatic Sickle Cell Syndrome (see section 5.1).
Maltese: Siklos hu indikat għall-prevenzjoni ta' kriżijiet rikorrenti vażookklussivi bl-uġigħ, inkluż is-sindromu akut tas-sider f'pazjenti adulti, adolexxenti u tfal li għandhom aktar minn sentejn li jbatu misSindromu tas-Sickle Cells sintomatiku (ara sezzjoni 5.1).
English: The most frequently reported adverse reaction is myelosuppression with neutropenia as the most common manifestation.
Maltese: L-aktar reazzjoni avversa irrappurtata frekwentament hi majelsoppressjoni b'newtropenija bħala l aktar manifestazzjoni komuni.
English: Infections and infestations: Not known:
Maltese: Infezzjonijiet u infestazzjonijiet:
English: Frequencies are defined as very common (>1/10), common (>1/100 to <1/10), uncommon (>1/1,000 to <1/100), rare (>1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
Maltese: Il-frekwenzi huma definiti bħala komuni ħafna (≥ 1/10), komuni (≥ 1/100 sa < 1/10), mhux komuni (≥ 1/1,000 sa < 1/100), rari (≥ 1/10,000 sa < 1/1,000), rari ħafna (< 1/10,000), mhux magħruf
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: Reċentament, hydroxycarbamide wera li hu assoċjat mal-ġenerazzjoni ta' nitric oxide, b'hekk jissuġġerixxi li nitric oxide jistimola l-produzzjonit ta' cyclic guanosine monophosphatase (cGMPcyclic guanosine monophosphatase), li wara jattiva kinase proteiku u jżid il-produzzjoni ta' HbF.
English: Pregnancy, breast-feeding and fertility
Maltese: Tqala u treddigħ u fertilità
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 webportal.
Maltese: Ir-rekwiżiti biex jiġu ppreżentati rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont lArtikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikat fuq il portal elettroniku Ewropew tal-mediċini.
English: Phone: +33 1 72 69 01 86 Fax: +33 1 73 72 94 13
Maltese: +33 1 72 69 01 86 Fax:
English: Patients with normal (creatinine clearance CrCl>80 ml/min), mild (CrCl 60-80 ml/min), moderate (CrCl 30 - 60 ml/min), or severe (<30 ml/min) renal impairment received hydroxycarbamide as a single dose of 15 mg/kg b.w.
Maltese: (CrCl 30 - <60 ml/min), jew severi (<30 ml/min) irċevew hydroxycarbamide bħala doża waħda ta' 15 mg/kg ta' piż tal-ġisem bl-użu ta' kapsuli ta' 200 mg, 300 mg jew 400 mg.
English: In nearly all clinical studies conducted in Sickle Cell Syndrome, hydroxycarbamide reduced the frequency of vaso-occlusive episodes by 66% to 80%, in children and in adults.
Maltese: Kważi fl-istudji kliniċi kollha li saru bis-Sindromu tas-Sickle Cells, hydroxycarbamide naqqas ilfrekwenza ta' episodji vażookklussivi fit-tfal u fil-kbar b'66% sa 80%.
English: Siklos 1000 mg film-coated tablets EU/1/07/397/001
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/07/397/001
English: Parvovirus B19 infection Neoplasms, benign, malignant and unspecified Not known:
Maltese: infezzjonijiet ikkawżati mill-virus Parvovirus B19, fsad ta'demm, disturbi gastrointestinali, rimettar,
English: The yearly frequency of acute chest syndrome was also reduced by 25 to 33% under hydroxycarbamide in several studies.
Maltese: Il-frekwenza annwali tas-sindromu akut tas-sider ukoll naqset b'25 sa 33% taħt hydroxycarbamide f'diversi studji..
English: The volume of distribution at steady state adjusted for bioavailability is 0.57 L/kg in patients with Sickle Cell Syndrome (amounting to approximately 72 and 90 L in children and adults, respectively).
Maltese: distribuzzjoni fl-istat fiss aġġustat għall-bijodisponibilità hu ta' 0.57 L/kg f'pazjenti bis-Sindromu tasSickle Cells (jammonta għal madwar 72 u 90 L fi tfal u adulti, ripsettivament).
English: Siklos 1000 mg tablets hydroxycarbamide
Maltese: SIKLOS 1000 mg pilloli hydroxycarbamide
English: Leg ulcers are a common complication of Sickle Cell Syndrome, but have also been reported in patients treated with hydroxycarbamide.
Maltese: Ulċeri fis-saqajn huma komplikazzjoni komuni tas-Sindromu tas-Sickle Cells, imma ġew irrappurtati wkoll f'pazjenti kkurati b'hydroxycarbamide.
English: 4.5 Interaction with other medicinal products and other forms of interaction
Maltese: Interazzjoni ma' prodotti mediċinali oħra u forom oħra ta' interazjoni
English: Information sharing is especially required for - antiretroviral medicines (those that inhibit or destroy a retrovirus such as HIV), e.g. didanosine,
Maltese: Qsim tal-informazzjoni hija speċjalment meħtieġa għal - mediċini antiretrovirali (dawk li jinibixxu jew jeqirdu retrovirus bħal HIV), eż. didanosine,
English: Acute chest syndrome is a frequent life-threatening complication of Sickle Cell Syndrome and is characterised by chest pain or fever or dyspnoea with recent infiltrate on chest X-ray.
Maltese: Is sindromu akut tas-sider hu komplikazzjoni frekwenti tas-Sindromu tas-Sickle Cells li jista' jkun fatali u hu kkaratterizzat minn uġigħ fis-sider jew deni jew qtugħ ta' nifs b'infiltrat reċenti jidher fuq X-ray tas sider.
English: Neutropenia is generally the first and most common manifestation of haematological suppression.
Maltese: Newtropenja hi ġeneralment l-ewwel u l-aktar manifestazzjoni komuni ta' soppressjoni ematoloġika.
English: Siklos 1000 mg film-coated tablets Pack size of 30 tablets.
Maltese: Siklos 1000 mg pilloli miksija b'rita Daqs tal-pakkett ta' 30 pillola.
English: Systemic and cutaneous lupus erythematous
Maltese: Ulċeri fir-riġlejn Lupus erythematous sistemika u tal-ġilda
English: After oral administration of 20 mg/kg of hydroxycarbamide, a rapid absorption is observed with peak plasma levels of about 30 mg/L occurring after 0.75 and 1.2 h in children and adult patients with Sickle Cell Syndrome, respectively.
Maltese: Wara l-għoti mill-ħalq ta' 20 mg/kg ta' hydroxycarbamide, jiġi osservat assorbiment rapidu bl-ogħla livelli fil-plażma ta' madwar 30 mg/L jintlaħqu minn 0.75 sa 1.2 ta' siegħa wara f'pazjenti tfal u adulti bis-Sindromu tas-Sickle Cells, rispettivament.
English: Hydroxycarbamide administered to male rats at 60 mg/kg b.w./day (about double the recommended usual maximum dose in humans) produced testicular atrophy, decreased spermatogenesis and significantly reduced their ability to impregnate females.
Maltese: Hydroxycarbamide mogħti lill-firien irġiel f'doża ta' 60 mg/kg ta' piż tal-ġisem/kuljum (kważi ddoppju tad-doża massima rakkomandata fil-bnedmin) wassal għal atrofija testikolari, tnaqqis flispermatoġenesi u tnaqqis sinifikanti fil-kapaċità li jtaqqlu n-nisa.
English: Siklos 1000 mg film-coated tablets are off-white, capsule-shaped tablets marked with three score lines on both sides.
Maltese: Siklos 1000 mg pilloli miksija b'rita huma ta' lewn off-white, b'forma ta' kapsula, b'ferq triplu fuq iżżewġ naħat.
English: Addmedica, 37 rue de Caumartin, 75009 Paris, France
Maltese: Addmedica, 37 rue de Caumartin , 75009 Pariġi, Franza
English: Due to safety considerations, Siklos is contraindicated in patients with severe hepatic impairment (see sections 4.3 and 4.4).
Maltese: Minħabba konsiderazzjonijiet ta' sigurtà, Siklos hu kontraindikat f'pazjenti b'indeboliment serju tal-fwied (ara sezzjoni 4.3 u 4.4).
English: • Risk to male and female fertility, potential risk to foetus and breast feeding
Maltese: • Ir-riskju għall-fertilità maskili u femminili, ir-riskju potenzjali għall-fetu u t-treddigħ
English: Treatment follow-up
Maltese: TAL-PRODOTT MEDIĊINALI
English: Addmedica 37 rue de Caumartin 75009 Paris France
Maltese: Addmedica 37 rue de Caumartin 75009 Paris
English: As evaluated in a further study, in patients with a CrCl<60 ml/min the area under the curve was approximately 51% higher than in patients with a CrCl ≥60 ml/min, which suggests that a dose reduction of hydroxycarbamide by 50% may be appropriate in patients with a CrCl < 60 ml/min.
Maltese: Kif ġie evalwat fi studju ieħor, f'pazjenti bi CrCl <60 ml/min, l-erja taħt il-kurva kienet 51% aktar minn dik f'pazjenti bi CrCl ≥60 ml/min, dan jissuġġerixxi li tnaqqis fid-doża ta' hydroxycarbamide b'50% jista' jkun xieraq f'pazjenti bi CrCl < 60 ml/min. Emodijaliżi naqqset l-espożizzjoni ta' hydroxycarbamide bi 33% (ara sezzjonijiet 4.2 u 4.4).
English: Toxic ranges of myelosuppression as described in section 4.2.
Maltese: Limiti tossiċi ta' majelosoppressjoni hekk kif deskritt f'sezzjoni 4.2.
English: • Handling of broken tablets
Maltese: • Immanniġjar ta' pilloli maqsuma
English: • Place the required dose (preferably broken if Siklos 1000 mg tablet is used) in a teaspoon and add some water.
Maltese: • Poġġi d-doża meħtieġa (preferibbilment imfarrka jekk tintuża pillola Siklos 1000 mg) f'kuċċarina u żid ftit ilma.
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: Hydroxycarbamide jinfirex madwar il-ġisem uman kollu, jidħol fil-fluwidu ċerebrospinali, jidher filfluwidu peritoneali u axxite, u jikkonċentra fil-lewkoċiti u fl-eritroċiti.
English: As long as the patient responds to therapy either clinically or haematologically (e.g. increase of haemoglobin F (HbF), Mean Corpuscular Volume (MCV), neutrophil count) the dose of Siklos should be maintained.
Maltese: Sakemm il-pazjent jirrispondi klinikament jew ematoloġikament għall-kura (eż. żieda fl-emoglobina F (HbF), Mean Corpuscular Volume (MCV), għadd ta' newtrofili) id-doża ta' Siklos għandha tinżamm.
English: Siklos 100 mg is supplied in plastic bottles containing 60, 90 or 120 tablets.
Maltese: Siklos 100 mg hu formut fi fliexken tal-plastik li jkun fihom 60, 90 jew 120 pilolla.
English: Very rare side effects (may affect up to 1 in 10,000 people) or unknown frequency (frequency cannot be estimated from the available data):
Maltese: Effetti sekondarji rari ħafna (jistgħu jaffettwaw sa persuna 1 minn kull 10,000) jew ta' frekwenza mhux magħrufa :
English: A sustained clinical benefit was demonstrated in patients remaining on hydroxycarbamide treatment for up to 8 years.
Maltese: Benefiċċju kliniku sostnut intwera f'pazjenti li baqgħu fuq kura b'hydroxycarbamide sa 8 snin.
English: In patients with a creatinine clearance ≤ 60 ml/min the initial Siklos dose should be decreased by 50%.
Maltese: ≤ 60 ml/min, id-doża tal-bidu ta' Siklos trid titnaqqas b'50%.
English: In a repeated dose study in adult patients with Sickle Cell Syndrome approximately 60% of the hydroxycarbamide dose was detected in urine at steady state.
Maltese: Fi studju b'doża ripetuta f'pazjenti adulti b'Sindromu tas-Sickle Cells, madwar 60% tad-doża ta' hydroxycarbamide instabet fl-awrina fi stat fiss.
English: The adverse reactions are listed below by system organ class and absolute frequency.
Maltese: Ir-reazzjonijiet avversi huma elenkati hawn taħt, skont il-klassi tal-organi tas-sistema u l-frekwenza assoluta.
English: At concentrations ranging from 10 to 300 µM, hydroxycarbamide does not stimulate the in vitro ATPase activity of recombinant human P glycoprotein (PGP), indicating that hydroxycarbamide is not a PGP substrate.
Maltese: F'konċentrazzjonijiet li jvarjaw minn 10 sa 300 µM, hydroxycarbamide ma jistimulax l-attività ATPase in vitro ta' glycoprotein P rikombinanti umana (PGP), u b'hekk jindika li hydroxycarbamide mhux substrat ta'PGP. Għalhekk, mhi mistennija l-ebda interazzjoni f'każ tal-għoti flimkien ma' sustanzi li huma substrati taċ-ċitokromji P450 jew P
English: Vascular disorders: Not known:
Maltese: Disturbi vaskulari:
English: Hrvatska
Maltese: Nawsja
English: Cutaneous vasculitic toxicities, including vasculitic ulcerations and gangrene, have occurred in patients with myeloproliferative disorders during therapy with hydroxycarbamide.
Maltese: Tossiċitajiet vaskulitiċi tal-ġilda, inkluż ulċeri vaskulitiċi u kankrena, seħħew f'pazjenti b'kundizzjonijiet majeloproliferattivi waqt kura b'hydroxycarbamide.
English: Siklos 100 mg film-coated tablets hydroxycarbamide
Maltese: Siklos 100 mg pilloli hydroxycarbamide
English: OTHER
Maltese: SEKONDARJI
English: In adults, the total clearance adjusted for bioavailability was 9.89 L/h (0.16 L/h/kg) thereof 5.64 and 4.25 L/h by renal and non-renal clearance, respectively.
Maltese: F'adulti, it-tneħħija totali aġġustata għall bijodisponibilità kienet ta' 9.89 L/siegħa (0.16 L/siegħa/kg) b'madwar 5.64
English: Each tablet contains 100 mg of hydroxycarbamide.
Maltese: Kull pillola fiha 100 mg ta' hydroxycarbamide.
English: In the human, according to a retrospective analysis of a cohort of 123 adult patients treated with hydroxycarbamide, twenty-three pregnancies have been reported from 15 women treated with hydroxycarbamide and partners of 3 men treated with hydroxycarbamide.
Maltese: Fil-bniedem, skont analiżi retrospettiva ta' koorti ta' 123 pazjent adult ikkurati b'hydroxycarbamide, tlieta u għoxrin tqala ġew irrappurtati minn 15-il mara kkurati b'hydroxycarbamide u s-sieħba ta' 3 irġiel ikkurti b'hydroxycarbamide.
English: 37 rue de Caumartin 75009 Paris
Maltese: 37 rue de Caumartin 75009 Paris - Frankreich
English: In paediatric and adult patients with Sickle Cell Syndrome the systemic exposure to hydroxycarbamide at steady state was similar by means of the area under the curve.
Maltese: F'pazjenti pedjatriċi u adulti bis-Sindromu tas-Sickle Cells, l-espożizzjoni sistemika għal hydroxycarbamide fl-istat fiss kienet simili permezz tal-erja taħt il-kurva.
English: Wounds on the legs (leg ulcers), and modification of liver function.
Maltese: Feriti fis-saqajn (ulċeri tas-saqajn), funzjoni mibdula tal-fwied.
English: Each tablet contains 1,000 mg of hydroxycarbamide.
Maltese: Kull pillola fiha 1.000 mg ta' hydroxycarbamide.
English: EXP: In-use shelf life of broken tablets: 3 months
Maltese: Waqt l-użu ħajja fuq l-ixkaffa ta' pilloli maqsuma: 3 xhur
English: - Keep this leaflet.
Maltese: DETTALJI TA' EFFETTI
English: The starting dose of hydroxycarbamide is 15 mg/kg b.w.
Maltese: Id-doża tal-bidu ta' hydroxycarbamide hi ta' 15 mg/kg ta' piż tal-ġisem u d-doża tas-soltu hi bejn 15 u
English: Package leaflet: information for the user Siklos 100 mg film-coated tablets Siklos 1000 mg film-coated tablets hydroxycarbamide
Maltese: Fuljett ta' tagħrif: informazzjoni għall-utent Siklos 100 mg pilloli miksijab'rita Siklos 1000 mg, pilloli miksija b'rita
English: Hydroxycarbamide causes macrocytosis, which may mask the incidental development of folic acid and vitamin B12 deficiency.
Maltese: hydroxycarbamide hi kważi kompleta hekk kif msejsa f'indikazzjonijiet oħra minbarra s-Sindromu tas-Sickle Cells.
English: Other known pharmacological effects of hydroxycarbamide which may contribute to its beneficial effects in Sickle Cell Syndrome include decrease of neutrophils, increase of the water content of erythrocytes, increase of the deformability of sickled cells, and altered adhesion of red blood cells to the endothelium.
Maltese: Effetti farmakoloġiċi oħra magħrufa ta' hydroxycarbamide li jistgħu jikkontribwixxu għall-effetti benefiċi tiegħu fis-Sindromu taċ-ċelluli f'sura ta' minġel jinkludu tnaqqis fin-newtrofili, żieda filkontenut tal-ilma fl-eritroċiti, żieda fid-deformabilità ta' ċelluli f'forma ta' minġel, u tibdil fl-adeżjoni taċ-ċelluli ħomor tad-demm mal-endotilju.
English: Leg ulcers
Maltese: U L-UŻU
English: Teratogenicity was characterised by partially ossified cranial bones, absence of eye sockets, hydrocephaly, bipartite sternebrae, missing lumbar vertebrae.
Maltese: It-teratoġeniċità kienet ikkaratterizzata minn għadam fir-ras mhux ossifikat għal kollox, nuqqas ta' ħofor għall-għajnejn, idroċefalu, bipartite sternebrae, rkiekel lumbari nieqsa.
English: Haematologic recovery usually occurs within two weeks.
Maltese: Irkupru ematoloġiku normalment iseħħ f'ġimagħtejn.
English: Hydroxycarbamide may decrease sperm production in male patients while they are being treated.
Maltese: Hydroxycarbamide hu maħsub li hu karċinoġenu fi speċi differenti.
English: In adults with Sickle Cell Syndrome, mean cumulative urinary hydroxycarbamide excretion was 62% of the administered dose at 8 hours, and thus higher than in cancer patients (35-40%).
Maltese: F'adulti bis-Sindromu tas-Sickle Cells, it-tneħħija medju kumulattiva ta' hydroxycarbamide fl-awrina kienet ta' 62% tad-doża li ngħatat fi 8 sigħat, u b'hekk aktar milli f'pazjenti bil-kanċer (35- 40%).
English: Siklos may hence decrease the ability of men to father children.
Maltese: Tista' tkun effett minħabba li l-kundizzjonijiet ġenerali tjiebu.
English: These adverse reactions are expected based on the pharmacology of hydroxycarbamide.
Maltese: Dawn ir reazzjonijiet avversi huma mistennija meta tibbaża fuq il-farmakoloġija ta' hydroxycarbamide.
English: 3 Mainly due to an infection with Parvovirus or a splenic sequestration.
Maltese: 3 Ġeneralment minħabba infezzjoni minn Parvovirus jew sekwestru tal-milsa.
English: Specifically, the safety of hydroxycarbamide had been examined retroactively from cohorts of 123 adults over 13 years and 352 children older than 2 years and adolescents up to 12 years.
Maltese: adult li kellhom iktar minn 13-il sena u 352 tifel u tifla li kellhom iktar minn sentejn u adolexxenti li kellhom sa 12-il sena.
English: Siklos 100 mg film-coated tablets are off-white, oblong-shaped tablets with a break line on both sides.
Maltese: Siklos 100 mg pilloli miksija b'ritahuma ta' lewn off-white, f'għamla oblonga b'ferq fuq iż-żewġ naħat.
English: Leukaemia and in elderly patients, skin cancers Blood and lymphatic system disorders: Very common: Bone marrow depression1 including neutropenia (< 2.0 x 109/L), reticulocytopenia (< 80 x 109/L), macrocytosis2
Maltese: Tnaqqis tal-mudullun1 li tinkludi newtropenija (< 2.0 x 109/L),
English: and the usual dose is between 15 and 30 mg/kg b.w./day.
Maltese: 30 mg/kg ta' piż tal-ġisem/kuljum.
English: In patients, whose CrCl was below 60 ml/min or patients with end-stage renal disease the mean exposure to hydroxycarbamide was approximately 64% higher than in patients with normal renal function.
Maltese: F'pazjenti li kellhom CrCl anqas minn 60 ml/min jew pazjenti b'mard tal-kliewi fl-aħħar stadju, l-espożizzjoni medja għal hydroxycarbamide kienet ta' madwar 64% aktar minn pazjenti b'funzjoni normali tal-kliewi.
English: Soreness, violet erythema, oedema on palms and soles followed by scaling of hand and feet, severe generalised hyperpigmentation of the skin and stomatitis have been observed.
Maltese: Ukoll, fil-firien, ġiet osservata atrofija testikolari bi spermatoġenesi mnaqqsa, filwaqt li fil-klieb ġie osservat waqfien spermatoġeniku riversibbli.
English: 1 Haematological recovery usually occurs within two weeks of withdrawal of hydroxycarbamide.
Maltese: 1 Irkupru ematoloġiku normalment iseħħ fi żmien ġimagħtejn mill-waqfien ta' hydroxycarbamide .
English: Elevated liver enzymes Skin and subcutaneous tissue disorders: Common Skin reactions (for example oral, ungual and cutaneous pigmentation) and oral mucositis.
Maltese: Reazzjonijiet tal-ġilda (pereżempju pigmentazzjoni tal-ħalq, taddwiefer u tal-ġilda ) u mukożite orali.
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 flimkien ta' hydroxycarbamide ma' prodotti mediċinali majelosoppressivi oħra jew terapija ta' radjazzjoni tista' iżżid id-dipressjoni tal-mudullun tal-għadam, disturbi ġastrointestinali jew mukożite.
English: Each Siklos 100 mg film-coated tablet contains 100 mg hydroxycarbamide.
Maltese: Kull pillola miksija b'rita ta' Siklos 100 mg fiha 100 mg hydroxycarbamide.
English: Cardiovascular effects and haematological changes were observed in some species.
Maltese: Effetti kardjovaskulari u tibdiliet ematoloġiċi ġew osservati f'ċerti speċi.
English: Each half of tablet is embossed “H” on one side.
Maltese: Kull nofs pillola hu intaljat b'"H" fuq naħa waħda.
English: Contents of the pack and other information What Siklos contains
Maltese: Kontenut tal-pakkett u informazzjoni oħra X'fih Siklos
English: 37 rue de Caumartin 75009 Paris/Parijs France/Frankreich/Frankrijk Tel : +33 (0)1 72 69 01 86
Maltese: 37 rue de Caumartin 75009 Paris/Parijs France/Frankreich/Frankrijk
English: Pregnancy
Maltese: Retikuloċiti
English: Amenorrhea General disorders and administration site conditions: Not known:
Maltese: Disturbi tad-demm u tas-sistema limfatika:
English: This leaflet was last approved in
Maltese: Sommarju f'għamla ta' tabella ta' reazzjonijiet avversi
English: The clinical data obtained in patients with Sickle Cell Syndrome have not shown evidence of adverse reactions of hydroxycarbamide on hepatic and renal function.
Maltese: It-tagħrif kliniku li nġabar minn pazjenti bis-Sindromu tas-Ċelluli sura ta' Minġelma wriex evidenza ta' reazzjonijiet avversi ta' hydroxycarbamide fuq il-funzjoni tal-fwied u tal-kliewi.