qanastek/EMEA-V3 huggingface dataset:
Hydroxycarbamide is presumed to be a transspecies carcinogen.
Hydroxycarbamide huwa maħsub li huwa karċinoġenu fi speċi differenti.
In patients receiving long-term hydroxycarbamide for myeloproliferative disorders, secondary leukaemia has been reported.
F’ pazjenti li qed jingħataw hydroxycarbamide għat- tul minħabba mard mijeloproliferattiv, ġiet irrappurata lewkemja sekondarja.
It is unknown whether this leukemogenic effect is secondary to hydroxycarbamide or is associated with the patient’ s underlying disease.
Għadu mhux magħruf jekk dan l- effett lewkemoġeniku huwa sekondarju għal hydroxycarbamide jew jekk hux assoċjat mal- marda li l- pazjent diġà għandu.
Skin cancer has also been reported in patients receiving long-term hydroxycarbamide.
Kanċer tal- ġilda ġie wkoll irrappurtat f’ pazjenti li qed jirċievu hydroxycarbamide fit- tul.
Reversible azo- and oligo-spermia have been rarely observed in man, although these disorders are also associated with the underlying disease (see 4.8, 5.3).
Azo - u oligo- spermja riversibbli ġew osservati rarament fil- bniedem, għalkemm dawn il - mard huma wkoll assoċjati mal- marda li diġà hemm (ara 4. 8, 5. 3).
Specific interaction studies have not been performed with hydroxycarbamide.
Ma sarux studji speċifiċi dwar l- effett ta ’ mediċini jew ta ’ affarijiet oħra fuq hydroxycarbamide.
Potentially fatal pancreatitis and hepatotoxicity, and severe peripheral neuropathy have been reported in HIV-infected patients who received hydroxycarbamide in combination with antiretroviral agents particularly didanosine plus stavudine.
Pankrejatité u epatotossiċità potenzjalment fatali, u newropatija periferali severa ġew irrappurtati f’ pazjenti infettati b’ HIV li ngħataw hydroxycarbamide flimkien ma ’ aġenti antiretrovirali speċjalment didanosine flimkien ma ’ stavudine.
Patients treated with hydroxycarbamide in combination with didanosine, stavudine, and indinavir showed a median decline in CD4 cells of approximately 100/ mm3.
Pazjenti kkurati b’ hydroxycarbamide flimkien ma ’ didanosine, stavudine u indinavir kellhom tnaqqis medjan fiċ- ċelloli CD4 ta ’ madwar 100 / mm3.
4 Concurrent use of hydroxycarbamide and other myelosuppressive medicinal products or radiation therapy may increase bone marrow depression, gastro-intestinal disturbances or mucositis.
L- użu flimkien ta ’ hydroxycarbamide ma ’ prodotti mediċinali mijelosoppressivi oħra jew terapija ta ’ radjazzjoni tista ’ iżżid id- dipressjoni tal- mudullun ta ’ l- għadam, disturbi ġastro- intestinali jew mukosité.
An erythema caused by radiation therapy may be aggravated by hydroxycarbamide.
Eritema kkawżata minn terapija ta ’ radjazzjoni tista ’ tiġi aggravata b’ hydroxycarbamide.
Concomitant use of hydroxycarbamide with a live virus vaccine may potentiate the replication of the vaccine virus and/ or may increase the adverse reaction of the vaccine virus, because normal defence mechanisms may be suppressed by hydroxycarbamide therapy.
L- użu flimkien ta ’ hydroycarbamide ma ’ vaċċin ta ’ virus ħaj tista ’ ssaħħaħ ir- replikazzjoni tal- virus fil- vaċċin u/ jew tista ’ żżid ir- rejazzjoni avversa tal- virus fil- vaċċin, minħabba li l- mekkaniżmi ta ’ difiża normali jistgħu jkunu soppressi mill- kura b’ hydroxycarbamide.
Vaccination with a live vaccine in a patient taking hydroxycarbamide may result in severe infections.
Vaċċinazzjoni b’ vaċċin ħaj f’ pazjent li qed jieħu hydroxycarbamide tista ’ tirriżulta f’ infezzjoni serja.
Generally, the patient's antibody response to vaccines may be decreased.
4 antikorpi tal- pazjent għall- vaċċini jistà jonqos.
Treatment with Siklos and concomitant immunisation with live virus vaccines should only be performed if benefits clearly outweigh potential risks.
Kura b’ Siklos u fl- istess ħin imunizazzjoni b’ vaċċin b’ virus ħaj trid issir biss jekk il- benefiċċji ħuma ħafna aktar mir- riskji potenzjali.
Studies in animals have shown reproductive toxicity (see section 5.3).
Studji fl- annimali wrew tossiċità riproduttiva (ara sezzjoni 5. 3).
Patients on hydroxycarbamide should be made aware of the theoretical risks to the foetus and those wishing to conceive should stop treatment 3 to 6 months before pregnancy if possible.
Pazjenti li qed jieħdu hydroxycarbamide għandhom jiġu mgħarrfa dwar ir- riskji teoretiċi għall- fetu u jekk possibli dawk li jixtiequ joħorġu tqal għandhom iwaqqfu l- kura 3 sa 6 xhur qabel it- tqala.
The evaluation of the risk- benefit ratio should be made on an individual basis outweighing the respective risk of hydroxycarbamide therapy against the switch to a blood transfusion programme.
L- istima tal- proporzjon ta ’ riskju- benefiċċju għandha ssir fuq bażi individwali u din trid tgħeleb ir- riskju rispettiv ta ’ kura b’ hydroxycarbamide kontra it- tibdil għall- programm ta ’ trasfużjoni tad- demm.
Based on the limited amount of available information, in case of an exposure to hydroxycarbamide during pregnancy, a careful follow-up with adequate clinical, biological and ultrasonographic examinations should be considered.
Ibbażat fuq l- ammont limitat ta ’ informazzjoni disponibbli, f’ każ ta ’ espożizzjoni għal hydroxycarbamide waqt it- tqala, għandha tiġi kkunsidrata vista ta ’ wara b’ kawtela, b’ eżaminazzjonijiet kliniċi, bijoloġiċi u ultrasonografiċi xierqa.
Women of child-bearing potential should be advised to use adequate birth-control measures during treatment with hydroxycarbamide.
Nisa b’ potenżjal li jkollhom tfal għandhom ikunu avżati sabiex jużaw miżuri xierqa ta ’ kontroll tat - twelid waqt kura b’ hydroxycarbamide.
The use of effective contraception is strongly recommended.
L- użu ta ’ kontraċezzjoni effettiva hija rakkomandata ħafna.
If the patient becomes pregnant while taking Siklos, she should be advised of the potential risk to the foetus.
Jekk il- pazjenta tinqabad tqila waqt li qed tieħu Siklos, għandha tkun avżata dwar ir- riskju potenzjali għall- fetu.
Hydroxycarbamide is excreted in human milk.
Hydroxycarbamide joħroġ fil- ħalib tal- bniedem.
Because of the potential for serious adverse reactions in infants, breast-feeding must be discontinued while taking Siklos.
Minħabba r- riskju potenzjali għall- effetti avversi serja fit- trabi, treddigħ irid jitwaqqaf waqt li qed jingħata Siklos.
However, patients should be informed that dizziness has been reported from literature, but not commonly.
Iżda, pazjenti iridu jiġu mgħarrfa li sturdament ġie rrappurtat mill- letteratura, iżda ma ’ kienx komuni.
Patients should be advised not to drive or operate machines, if dizziness is experienced while taking Siklos.
Il- pazjenti jridu jiġu avżati sabiex ma jsuqux jew iħaddmu magni jekk iħossuhom sturduti waqt li qed jieħdu Siklos.
Specifically the safety of hydroxycarbamide had been examined retroactively from cohorts of 123 adults and 352 paediatric patients, over 13 years and up to 12 years respectively.
Speċifikament is- sikurtà ta ’ hydroxycarbamide ġiet eżaminata retroattivament minn ko- orti ta ’ 123 adult u 352 pazjent pedjatriku, ’ l fuq minn 13- il sena u sa ’ 12- il sena ripettivament.
The most frequently reported adverse reaction is myelosuppression with neutropenia as the most common manifestation.
L- aktar rejazzjoni avversa irrappurtata frekwentament hija mijelsoppressjoni b’ newtropenja bħala l - aktar manifestazzjoni komuni.
Bone marrow depression is the dose-limiting toxic effect of hydroxycarbamide.
Dipressjoni tal- mudullun ta ’ l- għadam hija l- effett tossiku li jillimita d - doża ta ’ hydroxycarbamide.
When the maximum tolerated dose is not reached transient myelotoxicity usually occurs in less than 10% of patients, while under the maximum tolerated dose more than 50% can experience reversible bone marrow suppression.
Meta d- doża massima li tiġi ttollerata ma tintlaħaqx, mijelotossiċità temporanja ġeneralment isseħħ f’ anqas minn 10% tal- pazjenti, filwaqt li bid- doża massima tollerata aktar minn 50% jistgħu ikollhom soppressjoni riversibbli tal- mudullun ta ’ l- għadam.
These adverse reactions are expected based on the pharmacology of hydroxycarbamide.
Dawn ir - rejazzjonijiet avversi huma mistennija meta tibbaża fuq il- farmakoloġija ta ’ hydroxycarbamide.
Gradual dose titration may help to diminish these effects (see section 4.2).
Titrazzjoni gradwali tad- doża tista ’ tgħin sabiex tnaqqas dawn l- effetti (ara sezzjoni 4. 2).
Frequencies are defined as very common (> 1/ 10), common
L- effetti avversi li huma kkunsidrati mill- inqas bħala possibilment relatati mal- kura huma mniżżla hawn taħt skond is- sistema tal- klassifika tal- organi u l- frekwenza assoluta.
5 (> 1/ 100 ,< 1/10), uncommon (> 1/ 1,000 ,< 1/100), rare (> 1/ 10,000, < 1/ 1,000), very rare (< 1/ 10,000), not known (cannot be estimated from the available data).
Il- frekwenzi huma definiti bħala 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), mhux magħrufa (ma jistgħux jiġu stmati minn tagħrif disponibbli).
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness:
F’ kull sezzjoni ta ’ frekwenza, l- effetti mhux mixtieqa huma mniżżlin f’ ordni dejjem tonqos skond is- serjeta tagħhom:
Not known:
Żieda fil- piz5 Mhux magħruf:
Blood and lymphatic system disorders:
5 Disturbi tad- demm u tas- sitema limfatika:
Bone marrow depression1 including neutropenia (< 2.0 x 109/ l), reticulocytopenia (< 80 x 109/ l), macrocytosis2
Dipressjoni tal- mudullun ta ’ l- għadam1 inkluż newtropenja (< 2. 0 x 109 / l), Komuni ħafna: retikuloċitopenja (< 80 x 109 / l), makroċitożi2 Tromboċitopenja (< 80 x 109 / l), anemija (emoglobina < 4. 5 g/ dl) 3 Komuni:
Common: disorders:
Disturbi fis- sistema nervuża:
Thrombocytopenia (< 80 x 109/ l), anaemia (haemoglobin < 4.5 g/ dl)3 Headache Dizziness
Uġigħ ta ’ ras Sturdament
Nausea Gastrointestinal disturbances, vomiting, gastrointestinal ulcer, severe hypomagnesaemia
Dardir Disturbi gastro- intestinali, rimettar, ulċera gastro- intestinali, ipomagnesimja severa
Skin reactions (for example oral, ungual and cutaneous pigmentation) and oral mucositis.
Reazzjonijiet tal- ġilda (per eżempju pigmentazzjoni tal- ħalq, tad- dwiefer u tal- ġilda) u mukosité orali.
Rash, melanonychia, alopecia Leg ulcers Cutaneous dryness Parvovirus B19 infection
Raxx, melanonychia, jaqgħa x- xahar Ulċeri fis- saqajn Ġilda xotta
Neoplasms, benign, malignant and unspecified
Infezzjonijiet u infestazzjonijiet:
Leukaemia and in elderly patients, skin cancers
Infezzjoni b’ Parvovirus B19
Bleeding
Fsad ta ’ demm
General disorders and administration site conditions:
Disturbi ġenerali u kondizzjonijiet fis- sit ta ’ l- għotja:
Hepathobiliary
Deni
Not known: disorders Rare:
Mhux magħruf:
Fever Elevated liver enzymes
Disturbi fil- fwied u fil- marrara:
Reproductive system and breast disorders:
Azospermja, oligospermja4 Rari ħafna:
1
Mhux magħrufa 1
Not known:
Amennoreja
Haematological recovery usually occurs within two weeks of withdrawal of hydroxycarbamide.
Rkupru ematoloġiku normalment iseħħ fi żmien ġimgħatejn mil- waqfien ta ’ hydroxycarbamide.
2 The macrocytosis caused by hydroxycarbamide is not vitamin B12 or folic acid dependent.
2 Il- makroċitożi kkawżata minn hydroxycarbamide mhijiex dipendenti fuq vitamina B12 jew aċidu foliku.
3 Mainly due to an infection with Parvovirus or a splenic sequestration.
3 Ġeneralment minħabba infezzjoni minn Parvovirus jew sekwestru tal- milsa.
4 Oligospermia and azoospermia are in general reversible, but have to be taken into account when fatherhood is desired (see section 5.3).
4 Oligospermja u azospermja huma ġeneralment riversibli, iżda iridu jiġu kkunsidrati meta jkun hemm xewqa li pazjent isir missier (ara sezzjoni 5. 3).
These disorders are also associated with the underlying disease.
Dan il- mard huma assoċjat ukoll ma ’ mal- marda li diġà hemm.
5 Which may be an effect of improved general conditions.
5 Tista ’ tkun effett minħabba li l- kondizzjonijiet ġenerali tjiebu.
The clinical data obtained in patients with Sickle Cell Syndrome have not shown evidence of adverse effects of hydroxycarbamide on hepatic and renal function.
It- tagħrif kliniku li nġabar minn pazjenti bis- Sindromu Sickle Cell ma weriex evidenza ta ’ effetti avversi ta ’ hydroxycarbamide fuq il- funzjoni tal- fwied u tal- kliewi.
Acute mucocutaneous toxicity has been reported in patients receiving hydroxycarbamide at dosages several times above the therapeutic dose.
Tossiċità mukokutanja akuta ġiet irrappurtata f’ pazjenti li qed jingħataw hydroxycarbamide f’ dożi ħafna drabi akbar mid- doża terapewtika.
Soreness, violet erythema, oedema on palms and soles
Uġigħ, eritema vjola, nefħa fil- pali ta ’ l- idejn u l- qiegħ tas - saqajn seġwit minn formazzjoni ta ’ qxur fl- idejn u s- saqajn, iperpigmentazzjoni ġeneralizzata qawwija tal- ġilda u stomatité ġew osservati.
6 followed by scaling of hand and feet, severe generalised hyperpigmentation of the skin and stomatitis have been observed.
6 piż tal- ġisem / kuljum).
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).
Huwa rakkomandat li l- għadd tad- demm ikunu sorveljati għal ħafna ġimgħat wara doża eċċessiva minħabba li l- irkupru jista ’ jittardja.
Treatment of overdose consists of gastric lavage, followed by symptomatic treatment and control of bone marrow function.
Kura ta ’ doża eċċessiva tikkonsisti f’ tindif ta ’ l- istonku, seġwit minn kura sintomatika u kontroll tal - funżjoni tal- mudullun ta ’ l- għadam.
Other antineoplastic agents, ATC code:
Aġenti antinejoplastiċi oħra, Kodiċi ATC:
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.
Kważi fl- istudji kliniċi kollha li saru bis- Sindromu Sickle Cell, hydroxycarbamide naqqas il - frekwenza ta ’ episodji vaso- okklussivi fit- tfal u fil- kbar b’ 66% sa 80%.
The same decrease was observed for the number of hospital admissions and the number of days of hospitalisation in the treated groups.
L- istess tnaqqis deher fin - numru ta ’ visti fl- isptar u fin- numru ta ’ ġranet li wieħed idum l- isptar fil- gruppi kkurati.
The yearly frequency of acute chest syndrome was also reduced by 25 to 33% under hydroxycarbamide in several studies.
Il- frekwenza annwali tas- sindromu akut tas- sider ukoll naqas b’ 25 sa 33% taħt hydroxycarbamide f’ diversi studji..
Acute chest syndrome is a frequent life-threatening complication of Sickle Cell Syndrome and is characterized by chest pain or fever or dyspnoea with recent infiltrate on chest X-ray.
Is- sindromu akut tas- sider huwa komplikazzjoni frekwenti tas- Sindromu Sickle Cell li jista ’ jkun fatali u huwa karatterizzat minn uġigħ fis- sider jew deni jew qtugħ ta ’ nifs b’ infiltrat reċenti jidher fuq X- ray tas- sider.
A sustained clinical benefit was demonstrated in patients remaining on hydroxycarbamide treatment for up to 8 years.
Benefiċċju kliniku sostnut intwera f’ pazjenti li baqgħu fuq kura b’ hydroxycarbamide sa 8 snin.
The specific mechanism of action of hydroxycarbamide is not fully understood.
Il- mekkaniżmu ta ’ azzjoni speċifiku ta ’ hydroxycarbamide mhux magħruf għal kollox.
One of the mechanisms by which hydroxycarbamide acts is the elevation of foetal haemoglobin (HbF) concentrations in sickle cell patients.
Wieħed mill - mekkaniżmi ta ’ kif jaħdem hydroxycarbamide huwa li jgħolli l- konċentrazzjoni tal- emoglobina tal - fetu (HbF) f’ pazjenti b’ sickle cell.
HbF interferes with the polymerisation of HbS and thus impedes the sickling of red blood cell.
HbF tinterferixxi mal- polimerizazzjoni ta ’ HbS u b’ hekk timpedixxi ċ- ċellola l- ħamra tad- demm milli ssir f’ forma ta ’ minġel.
In all clinical studies, there was a significant increase in HbF from baseline after hydroxycarbamide use.
Fl- istudji kliniċi kollha, kien hemm żieda sinifikanti f’ HbF mill- linja bażi wara l- użu ta ’ hydroxycarbamide.
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.
Reċentament, hydroxycarbamide wera li huwa assoċjat mal- ġenerazzjoni ta ’ nitric oxide, b’ hekk jissuġġerixxi li nitric oxide jistimola l- produzzjonit ta ’ cyclic guanosine monophosphatase (cGMP), li wara jattiva kinase protejiku u jżid il- produzzjoni ta ’ HbF.
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.
Effetti farmakoloġiċi oħra magħrufa ta ’ hydroxycarbamide li jistgħu jikkontribwixxu għall- effetti benefiċi tiegħu fis- Sindromu Sickle Cell jinkludu tnaqqis fin- newtrofili, żieda fil- kontenut ta ’ l- ilma fl- eritroċiti, żieda fid- deformabilità ta ’ ċelloli f’ forma ta ’ minġel, u tibdil fl- adeżjoni taċ- ċelloli ħomor tad- demm ma ’ l- endotilju.
In addition hydroxycarbamide causes an immediate inhibition of DNA synthesis by acting as a ribonucleotide reductase inhibitor, without interfering with the synthesis of ribonucleic acid or protein.
Hydroxycarbamide jikkawża wkoll inibizzjoni immedijata tas- sintesi tad- DNA billi jagħmila ta ’ inibitur ribonucleotide reductase, mingħajr ma jinterferixxi mas- sintesi ta ’ ribonucleic acid jew protejina.
Beside the inconstant correlation between reduction of crisis rate and the increase in HbF, the cytoreductive effect of hydroxycarbamide, particularly the drop of neutrophils, was the factor with the strongest correlation to a reduced crisis rate.
Apparti mill- korrelazzjoni mhux konsistenti bejn it- tnaqqis fir- rata ta ’ krisi u ż- żieda f’ HbF, l- effett ċitoriduttiv ta ’ hydroxycarbamide, partikolarment it- tnaqqis fin- newtrofili, kien il- fattur bl- akbar korrelazzjoni għal tnaqqis fir- rata ta ’ krisi.
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.
Wara għotja mill- ħalq ta ’ 20 mg/ kg ta ’ hydroxycarbamide, tiġi osservata assorbment rapidu bl- għola livelli fil- plażma ta ’ madwar 30 mg/ l jintlaħqu minn 0. 75 sa ’ 1. 2 h wara f’ pazjenti tfal u adulti bis- Sindromu Sickle Cell, rispettivament.
The total exposure up to 24 h post-dose is 124 mg*h/ l in children and adolescents and 135 mg*h/ l in adult patients.
L- espożizzjoni totali sa ’ 24 h wara d- doża hija ta ’ 124 mg* h/ l fi tfal u adolexxenti u 135 mg* h/ l f’ pazjenti adulti.
The oral bioavailability of hydroxycarbamide is almost complete as assessed in indications other than Sickle Cell Syndrome.
Il- bijodisponibilità orali ta ’ hydroxycarbamide hija kważi kompleta hekk kif msejsa f’ indikazzjonijiet oħra minbarra s- Sindromu Sickle Cell.
7 Distribution:
Distribuzzjoni:
Hydroxycarbamide distributes rapidly throughout the human body, enters the cerebrospinal fluid, appears in peritoneal fluid and ascites, and concentrates in leukocytes and erythrocytes.
Hydroxycarbamide jiddistribwixxi malajr madwar il- ġisem uman kollu, jidħol fil - fluwidu ċerebrospinali, jidher fil- fluwidu peritonejali u axxite, u jikkonċentra fil- lewkoċiti u fl - eritroċiti.
The estimated volume of distribution of hydroxycarbamide approximates total body water.
Il -
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).
7 volum ta ’ distribuzzjoni fi stat stabbli aġġustat għall- biodisponibilità hu ta ’ 0. 57 l/ kg f’ pazjenti bis - Sindromu Sickle Cell (jammonta għal madwar 72 u 90 l fi tfal u adulti, ripsettivament).
The extent of protein binding of hydroxycarbamide is unknown.
L- ammont ta ’ twaħħil mal- protejini ta ’ hydroxycarbamide mhux magħruf.
The biotransformation pathways as well as the metabolites are not fully characterised.
Il- passaġġi ta ’ bijotransformazzjoni kif wkoll il- metaboliti m’ humiex ikkaratterizzati kompletament.
Urea is one metabolite of hydroxycarbamide.
Urea huwa metabolit wieħed ta ’ hydroxycarbamide.
Hydroxycarbamide at 30, 100 and 300µM is not metabolised in vitro by cytochrome P450s of human liver microsomes.
Hydroxycarbamide f’ konċentrazzjoni ta ’ 30, 100 u 300µM mhux metabolizzat in vitro miċ- ċitokromju P450s tal- mikrosomi tal- fwied uman.
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.
F’ konċentrazzjonijiet li jvarjaw minn 10 sa ’ 300µM, hydroxycarbamide ma jistimulax l- attività ATPase in vitro ta ’ glycoprotein P rikombinanti umana (PGP), u b’ hekk jindika li hydroxycarbamide mhux sustrat ta’ PGP.
Hence, no interaction is to be expected in case of concomitant administration with substances being substrates of cytochromes P450 or P-glycoprotein.
Għalhekk, m’ hu mistenni l- ebda interazzjoni f’ każ ta ’ l- għoti flimkien ma ’ sustanzi li huma substrati taċ- ċitokromji P450 jew P - glycoprotein.
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.
Fi studju b’ doża ripetuta f’ pazjenti adulti b’ Sindromu Sickle Cell, madwar 60% tad - doża ta ’ hydroxycarbamide nstabet fl- awrina fi stat stabbli.
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.
F’ adulti, it- tneħħija totali aġġustata għall - biodisponibilità kienet ta ’ 9. 89 l/ h (0. 16 l/ h/ kg) b’ madwar 5. 64 l/ h tneħħija mill- kliewi u 4. 25 l/ h tneħħija mhux mill- kliewi.
The respective value for total clearance in children was 7.25 l/ h (0.20 l/ h/ kg) with 2.91 and 4.34 l/ h by renal and non-renal pathways.
Il- valur rispettiv għat- tneħħija totali fit- tfal kien ta ’ 7. 25 l/ h (0. 20 l/ h/ kg) b’ madwar 2. 91 l/ h tneħħija mill- kliewi u 4. 34 l/ h tneħħija mhux mill- kliewi.
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%).
F’ adulti bis- Sindromu Sickle Cell, ir- rimi medju kumulattiv ta ’ hydroxycarbamide fl- awrina kien ta ’ 62% tad- doża li ngħatat f’ 8 siegħat, u b’ hekk aktar milli f’ pazjenti bil- kanċer (35 - 40%).
In patients with Sickle Cell Syndrome hydroxycarbamide was eliminated with a half-life of approximately six to seven hours, which is longer than reported in other indications.
F’ pazjenti bis- Sindromu Sickle Cell, hydroxycarbamide kien eliminat b’ half- life ta ’ madwar sitta sa ’ seba ’ siegħat, li huwa aktar minn dak irrappurtat f’ indikazzjonijiet oħra.
Geriatric, Gender, Race:
Ġerjatrika, Sess, Razza:
No information is available regarding pharmacokinetic differences due to age (except paediatric patients), gender or race.
M’ hemmx tagħrif disponibbli dwar id- differenzi farmakokinetiċi minħabba eta ’ (minbarra pażjenti pedjatriċi), sess jew razza.
Paediatric:
Pedjatrija:
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.
F’ pazjenti pedjatriċi u adulti bis- Sindromu Sickle Cell, l- espożizzjoni sistemika għal hydroxycarbamide fi stat stabbli kienet simili permezz ta ’ l’ erja taħt il- kurva.
The maximum plasma levels and the apparent volume of distribution related to body weight were well comparable between age groups.
Il- livelli massimi fil - plażma u l- volum apparenti ta ’ distribuzzjoni relatat mal- piż tal- ġisem kienu jixxiebħu ħafna bejn il - ġruppi ta ’ etajiet.
The time to reach maximum plasma concentration and the percentage of the dose excreted in urine were increased in children compared to adults.
Il- ħin sabiex tintlaħaq il- konċentrazzjoni massima fil- plażma u l- persentaġġ tad- doża li titneħħa fl- awrina kien aktar fit- tfal meta mqabbla mal- kbar.
In paediatric patients the half-life was slightly longer and the total clearance related to body weight slightly higher than in adult patients (see section 4.2).
F’ pazjenti pedjatriċi, il- half- life kienet ħarira itwal u t- tneħħija totali relatata mal- piż tal- ġisem ħarira għola minn f’ pazjenti adulti (ara sezzjoni 4. 2).
Renal impairment:
Indebliment renali:
As renal excretion is a pathway of elimination, consideration should be given to decreasing the dosage of Siklos in patients with renal impairment.
Minħabba li tneħħija mill kliewi hija passaġġ ta ’ eliminazzjoni, irid jiġi kkunsidrat tnaqqis fid- doża ta ’ Siklos f’ pazjenti b’ indeboliment renali.
In an open single-dose study in adult patients with Sickle Cell Syndrome the influence of renal function on pharmacokinetics of hydroxycarbamide was assessed.
Fi studju miftuħ b’ doża waħda f’ pazjenti adulti bis- Sindromu Sickle Cell, l- influwenza tal- funzjoni tal- kliewi fuq il- farmakokinetika ta ’ hydroxycarbamide ġiet studjata.
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. by using 200 mg, 300 mg, or 400 mg capsules.
Pazjenti bi problemi normali (tneħħija tal- krejatinina CrCl > ml/ min), ħfief (CrCl 60 - 80 ml/ min), moderati (CrCl 30 - < 60 ml/ min), jew severi (< 30 ml/ min) rċevew hydroxycarbamide bħala doża waħda ta ’ 15 mg/ kg b. w. bl- użu ta ’ kapsoli ta ’ 200 mg, 300 mg jew 400 mg.
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.
F’ pazjenti li kellhom CrCl anqas minn 60 ml/ min jew pazjenti b’ mard tal- kliewi ta ’ l - aħħar stadju, l- espożizzjoni medja għal hydroxycarbamide kienet ta ’ madwar 64% aktar minn pazjenti
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.
Kif ġie evalwat fi studju ieħor, f’ pazjenti bi CrCl < 60 ml/ min, l- arja 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% tista tkun xierqa f’ pazjenti bi CrCl < 60 ml/ min.
Haemodialysis reduced the exposure to hydroxycarbamide by 33% (see sections 4.2 and 4.4) Close monitoring of haematological parameters is advised in these patients.
Sorveljanza mil- qrib tal- parametri ematoloġiċi hija rakkomandata f’ dawn il- pazjenti.
There are no data that support specific guidance for dosage adjustment in patients with hepatic impairment, but, due to safety considerations, Siklos is contraindicated in patients with severe hepatic impairment (see section 4.2).
M’ hemmx tagħrif li jsostni gwida speċifika għall- aġġustament fid- doża f’ pazjenti b’ indeboliment tal- fwied, iżda, minħabba konsiderazzjonijiet ta ’ sikurtà, Siklos huwa kontra- indikat f’ pazjenti b’ indeboliment tal- fwied serju (ara sezzjoni 4. 2).
Close monitoring of haematological parameters is advised in patients with hepatic impairment.
Sorveljanza mil- qrib tal - parametri ematoloġiċi huja rakkomandata f’ pazjenti b’ indeboliment tal- fwied.
In preclinical toxicity studies the most common effects noted included bone marrow depression, lymphoid atrophy and degenerative changes in the epithelium of the small and large intestines.
Fi studji ta ’ tossiċità qabel l- użu kliniku, l- aktar effetti komuni nnutati nkludew dipressjoni tal - mudullun tal- għadam, atrofija limfojda u tibdiliet deġenerattivi fl- epitilju tal- musrana żgħira u l- kbira.
Cardiovascular effects and haematological changes were observed in some species.
Effetti kardjovaskulari u tibdiliet ematoloġiċi ġew osservati f’ ċertu speċi.
Also, in rats testicular atrophy with decreased spermatogenesis occurred, while in dogs reversible spermatogenic arrest was noted.
Wkoll, fil- firien, giet osservata atrofija testikolari b’ spermatoġenesi mnaqqsa, filwat li fil- klieb ġiet osservata waqfien spermatoġeniku riversibbli.
Hydroxycarbamide is unequivocally genotoxic in a wide range of test systems.
Hydroxycarbamide huwa bla dubju ġenotossiku f' sensiela wiesa ’ ta ’ sistemi ta ’ analiżi.
Conventional long-term studies to evaluate the carcinogenic potential of hydroxycarbamide have not been performed.
Ma sarux studji konvenzjonali fit- tul biex jistudjaw il- potenzjal karċinoġeniku ta ’ hydroxycarbamide.
However, hydroxycarbamide is presumed to be a transspecies carcinogen.
Iżda, hydroxycarbamide huwa meqjus bħala karċinoġenu fi speċi differenti.
Hydroxycarbamide crosses the placenta barrier and has been demonstrated to be a potent teratogen and embryotoxic in a wide variety of animal models at or below the human therapeutic dose.
Hydroxycarbamide jgħaddi mil- barriera tal- plaċenta u ntwera li huwa teratoġenu qawwi u embrijotossiku f’ varjeta wiesa ’ ta ’ annimali mudelli b’ doża terapewtika umana jew anqas.
Teratogenicity was characterised by partially ossified cranial bones, absence of eye sockets, hydrocephaly, bipartite sternebrae, missing lumbar vertebrae.
Teratoġeniċità kienet ikkaratterizzata minn għadam fir- ras mhux ossifikat għal kollox, nuqqas ta ’ ħofor għall- għajnejn, hydrocephaly, bipartite sternebrae, rukkell lombari nieqes.
Embryotoxicity was characterized by decreased foetal viability, reduced live litter sizes, and developmental delays.
Embrijotossiċità kienet ikkaratterizzata minn nuqqas fil- vijabilità tal- fetu, tnaqqis fil- kwantita ta ’ frieħ ħajjin, u ttardjar fl- iżvilupp.
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.
Fil- bniedem, skond analiżi retrospettiva ta ’ ko- orti 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.
Most (61%) had a normal outcome with regard to term and normal birth.
Ħafna minnhom (61%) kellhom riżultat normali rigward it- tul tat- tqala u twelid normali.
In the other cases with known evolution, pregnancy had been interrupted either voluntarily or upon medical advice.
Fil- każijiet l- oħra fejn huwa magħruf x’ ġara, it- tqala ġiet imwaqqfa jew volontarjament jew wara parir mediku.
Thus the data on a limited number of exposed pregnancies indicate no adverse effects on pregnancy or on the health of the foetus/ newborn.
Għalhekk it- tagħrif dwar in - numru limitat ta ’ tqala esposta għal- hydroxycarbamide ma ’ jindikax effetti avversi fuq it- tqala jew fuq is- saħħa tal- fetu/ tarbija.
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.
Hydroxycarbamide mgħoti lill- firien rġiel b’ doża ta ’ 60 mg/ kg piż tal- ġisem/ kuljum (kważi d- doppju tad- doża massima rakkomandata fil- bnedmin) wasslet għal atrofija testikolari, tnaqqis fl - ispermatoġenesi u tnaqqis sinnifikanti fil- kapaċità li jtaqqlu n- nisa.
Sodium stearyl fumarate Micro-crystalline cellulose and colloidal anhydrous silica Basic butylated methacrylate copolymer
Sodium stearyl fumarate Micro- crystalline cellulose u colloidal anhydrous silica Basic butylated methacrylate copolymer
26 months.
26 xahar
Store below 25°C.
Aħżen taħt 25°C.
For storage of unused broken tablets see section 6.6
Għall- ħażna ta ’ pilloli maqsuma mhux użati ara sezzjoni 6. 6.
PVC/ PVDC-Aluminium foil blisters. containing each 6 film-coated tablets.
9 Folji tal- PVC/ PVDC- aluminju li kull waħda fiha 6 pilloli miksija b’ rita.
Pack size: cartons with 30 film-coated tablets.
Kaxxi li fihom 30 pillola miksija b’ rita.
Siklos is a medicinal product that must be handled with care.
Siklos huwa prodott mediċinali li jrid jiġi wżat b’ attenzjoni.
People who are not taking Siklos and in particular pregnant women should avoid being in contact with hydroxycarbamide.
Persuni li mhux qed jieħdu Siklos u speċjalment nisa tqal għandhom jevitaw li jkunu f’ kuntatt ma ’ hydroxycarbamide.
In case the prescribed dosage requires breaking the tablet in halves or quarters, this should be done out of the reach of food.
F’ każ li d- dożaġġ preskritt jeħtieġ li l- pillola tinqasam min- nofs jew fi kwart, dan għandu jsir il - bogħod mil- ikel.
Powder eventually spilled from the broken tablet should be wiped up with a damp disposable towel, which is discarded.
Trab li eventwalment jaqa ’ mil- pillola maqsuma irid jintmesaħ b’ sarvetta niedja li tintuża darba biss, u wara tintrema.
Unused broken tablets must be replaced in the blister and put back in the box.
Pilloli maqsuma mhux użati għandhom jerġgħu jitpoġġew fil- folja li terġgħa titpoġġa fil- kaxxa.
Anyone handling Siklos should wash ones hands before and after contact with the tablets.
Min imiss Siklos għandu jaħsel idejh qabel u wara l- kuntatt mal- pilloli.
Any unused product or waste material should be disposed of in the accordance with local requirements.
Kull fdal tal- prodott li ma jkunx intuża jew skart li jibqa wara l- użu tal- prodott għandu jintrema kif jitolbu l- liġijiet lokali.
Addmedica 84 rue d'Amsterdam 75009 Paris France Phone: +33 1 72 69 01 86 Fax: +33 1 73 72 94 13 E-mail: contact@addmedica. com
Addmedica 84 rue d' Amsterdam F- 75009 Pariġi Franza Phone: +33 1 72 69 01 86 Fax: +33 1 73 72 94 13 E- mail: contact@ addmedica. com
Detailed information on this medicinal product is available on the European Medicines Agency (EMEA): http: / www. emea. eu. int
Informazzjoni dettaljata dwar dan il- prodott tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il- Mediċini (EMEA) http: // www. emea. eu
Les Bouillides - Sophia Antipolis F-06560 Valbonne France
Les Bouillides - Sophia Antipolis F- 06560 Valbonne Franza
The Marketing Authorisation Holder (MAH) shall ensure that, prior to launch, all physicians who are expected to prescribe Siklos are provided with a physician information pack containing the following: • Treatment guide for physicians • Patient information pack
Id- Detentur ta ’ L- Awtorizzazzjoni għat- tqegħid fis- Suq ser jiżgura li qabel it- tqegħid fis- suq, it - tobba kollha li huma mistennija jippreskrivu Siklos huma pprovduti b’ pakkett ta ’ informazzjoni għat- tabib li fih dan li ġej: • Gwida dwar il- kura għat- tobba • Pakkett ta ’ informazzjoni għall- pazjent
The treatment guide for physicians should contain the following key elements: • The Summary of Product Characteristics • Need for periodic blood counts and dose adjustment • Need for contraception • Risk to male and female fertility, potential risk to foetus and breast feeding • Growth follow-up of treated children • Handling of broken tablets • Management of adverse drug reactions
Il- gwida dwar il- kura għat- tobba għandu jkollha dawn l- elementi essenzjali: • Is- Sommarju tal- Karatteristiċi tal- Prodott • Il- bżonn li jsir għadd tad- demm perjodiku u aġġustament fid- doża • Il- bżonn ta ’ kontraċezzjoni • Ir- riskju għall- fertilità maskili u femminili, ir- riskju potenzjali għall- fetu u t- treddigħ • Osservazzjoni tat- tkabbir fi tfal ikkurati • Immanniġjar ta ’ pilloli maqsuma • Immanniġjar ta ’ reazzjonijiet avversi tal- mediċina
The patient information pack should contain the following key elements: • Package leaflet • Handling of broken tablets • Need for periodic blood counts • Information on crisis or infections • Need for contraception • Risk to male and female fertility, potential risk to foetus and breast feeding • Key signs and symptoms of serious adverse reactions • When to seek urgent attention from the health care provider • Information on growth follow-up of treated children for their parents
Il- pakkett ta ’ informazzjoni għall- pazjent għandu jkollu dawn l- elementi essenzjali: • Fuljett ta ’ tagħrif • Immanniġjar ta ’ pilloli maqsuma • Il- bżonn li jsir l- għadd tad- demm perjodiku • Informazzjoni dwar kriżijiet jew infezzjonijiet • Il- bżonn ta ’ kontraċezzjoni • Ir- riskju għall- fertilità maskili u femminili, ir- riskju potenzjali għall- fetu u t- treddigħ • Sinjali u sintomi importanti ta ’ reazzjonijiet avversi serji • Meta wieħed għandu jfittex attenzjoni urġenti minn professjonist fil- kura tas- saħħa • Informazzjoni għall- ġenituri dwar osservazzjoni tat- tkabbir fi tfal ikkurati
The MAH must implement this educational plan nationally, prior to marketing, and as agreed with the competent authorities in the Member States
Id- Detentur ta ’ L- Awtorizzazzjoni għat- tqegħid fis- Suq għandu jimplimenta dan il- pjan ta ’ edukazzjoni b’ mod nazzjonali qabel it- tqegħid fis- suq, u kif miftiehem ma ’ l- awtoritajiet kompetenti ta ’ l- Istati Membri.
12 OTHER CONDITIONS
KUNDIZZJONIJIET OĦRA 12 Sistema ta ’ Farmokoviġilanza
The Marketing Authorisation Holder must ensure that the system of pharmacovigilance, as described in version 3 presented in Module 1.8.1. of the Marketing Authorisation, is in place and functioning before the product is placed on the market.
Id- Detentur ta ’ L- Awtorizzazzjoni għat- tqegħid fis- Suq għandu jiżgura li s- sistema ta ’ farmakoviġilanza, kif deskritt f’ verżjoni 3 ppreżentata f’ Modulu 1. 8. 1 ta ’ l- Applikazzjoni għal - Awtorizzazzjoni għat- tqegħid fis- Suq, hija f’ postha u qed tiffunzjoni qabel u waqt li l- prodott jitqiegħed fis- suq.
The Marketing Authorisation Holder commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance plan as agreed in version 5 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation and any subsequent updates of the RMP agreed by the CHMP.
Id- Detentur ta ’ L- Awtorizzazzjoni għat- tqegħid fis- Suq jwiegħed li jwettaq l- istudji u l- attivitajiet ta ’ farmakoviġilanza oħrajn dettaljati fil- Pjan ta ’ Farmakoviġilanza kif miftiehem f’ verżjoni 5 tal- Pjan għall- Immanniġġjar ta ’ Riskji (RMP) ippreżentat f’ Modulu 1. 8. 2 ta ’ l- Applikazzjoni għal - Awtorizzazzjoni għat- tqegħid fis- Suq u kull aġġornament sussegwenti ta ’ l- RMP miftiehem mis - CHMP.
As per the CHMP Guideline on Risk Management Systems for medicinal products of human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
Skond il- Linji Gwida tas- CHMP dwar is- Sistemi għall- Immanniġġjar ta ’ Riskji għall- prodotti mediċinali għall- użu fil- bniedem, RMP aġġornat għandu jiġi ppreżentat fl- istess żmien mar- Rapport Perjodiku Aġġornat dwar is- Sigurtà (PSUR) sussegwenti.
- When new information is received that may impact on the current Safety Specification,
- Meta tinkiseb informazzjoni ġdida li jista ’ jkollha effett fuq l- Ispeċifikazzjonijiet ta ’ Sigurtà
Pharmacovigilance Plan or risk minimisation activities
kurrenti, Pjan ta ’ Farmakoviġilanza jew attivitajiet li jnaqqsu r- riskju
- Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being
- Fi żmien 60 ġurnata wara li tintlaħaq mira ta ’ mportanza (farmakoviġilanza jew tnaqqis ta ’
reached
riskju)
- At the request of the EMEA
- Mat- talba ta ’ l- EMEA.
LABELLING AND PACKAGE LEAFLET
FULJETT TA ’ TAGĦRIF
15 PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton
15 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA PAKKETT
Siklos 1000 mg film-coated tablets hydroxycarbamide
Siklos 1000 mg pilloli miksija b’ rita hydroxycarbamide
Each tablet contains 1000 mg hydroxycarbamide
Kull pillola fiha 1000 mg hydroxycarbamide
OTHER SPECIAL WARNING(S), IF NECESSARY Handle tablets with care.
TWISSIJA/ IET SPEĊJALI OĦRA, JEKK MEĦTIEĠA
Store below 25 °C.
Aħżen taħt 25 °C.
Addmedica, 84 rue d’ Amsterdam – 75009 Paris - France
Addmedica, 84 rue d’ Amsterdam – 75009 Pariġi Franza 16 12.
Lot:
LOTT:
17 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
17 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- ISTRIXXI JEW FUQ IL- FOLJI
Blisters
Folji
Siklos 1000 mg tablets hydroxycarbamide
Siklos 1000 mg pilloli hydroxycarbamide
PACKAGE LEAFLET:
FULJETT TA ’ TAGĦRIF
INFORMATION TO THE USER T
19 FULJETT TA ’ TAGĦRIF:
Siklos 1000 mg film-coated tablets hydroxycarbamide
Siklos 1000mg pilloli miksijab’ rita Hydroxycarbamide
Read all of this leaflet carefully before you start taking this medicine
Aqra sew dan il- fuljett kollu b’ attenzjoni qabel tibda tieħu din il- mediċina.
What Siklos is and what it is used for 2.
X’ inhu Siklos u għalxiex jintuża 2.
Before you take Siklos 3.
Qabel ma tieħu Siklos 3.
How to take Siklos 4.
Kif għandek tieħu Siklos 4.
Possible side effects 5 How to store Siklos 6.
Effetti sekondarji li jista ’ jkollu 5.
Further information
Kif taħżen Siklos 6.
WHAT SIKLOS IS AND WHAT IT IS USED FOR
X’ INHU SIKLOS U GĦALXIEX JINTUŻA
Siklos is used to prevent painful crises, including sudden chest pain, caused by Sickle Cell Syndrome, in children older than 2 years and adults.
Siklos jintuża biex jimpedixxi kriżi ta ’ uġigħ, inkluż uġigħ fis- sider f’ daqqa, ikkawżat mis- sindromu Sickle Cell, fi tfal akbar minn sentejn, u adulti.
Siklos will decrease the number of painful crises as well the need for hospitalisation linked with the disease.
Siklos inaqqas in- numru ta ’ kriżijiet b’ uġigħ, kif ukoll il- bżonn li wieħed jinżamm l- isptar, b’ konnessjoni mal- marda.
The active substance of Siklos, i. e. hydroxycarbamide, is a substance which inhibits growth and proliferation of some cells, such as blood cells; these effects lead to a reduction of circulating red, white and coagulation blood cells (myelosuppressive effect).
Is- sustanza attiva ta ’ Siklos i. e. hydroxycarbamide, hija sustanza li tinibixxi l- iżvilupp u l - proliferazzjoni ta ’ xi ċelloli, bħaċ- ċelloli tad- demm: dawn l- effetti iwasslu għal nuqqas ta ’ ċelloli ħomor, bojod u ċelloli tad- demm li jikolagolaw fiċ- ċirkolazzjoni (effett mijelosoppressiv).
In Sickle Cell Syndrome, hydroxycarbamide helps to prevent red blood cells from taking abnormal shape.
Fis - sindromu Sickle Cell hydroxycarbamide jgħin biex jippreveni ċ- ċelloli ħomor tad- demm milli jieħdu forma mhux normali.
BEFORE YOU TAKE SIKLOS
QABEL MA TIEĦU SIKLOS
Do not take Siklos
Tieħux Siklos
- if you are allergic (hypersensitive) to hydroxycarbamide or any of the other ingredients of
- jekk inti allerġiku/ a (tbagħti minn sensittività eċċessiva) għal hydroxycarbamide jew sustanzi oħra
Siklos, (see section 6)
ta ’ Siklos, (ara sessjoni 6)
- if you suffer from severe liver disease,
- jekk tbati minn mard tal- fwied serju,
- if you suffer from severe kidney disease,
- jekk tbati minn mard tal- kliewi serju,
- if you are myelosuppressed (i. e. if you have decreased production of red, white, or coagulating
- jekk inti mijelosoppressat (i. e. jekk għandek produzzjoni imnaqqsa ta ’ ċelloli ħomor, bojod jew
blood cells) as described in the section 3 (treatment follow-up)
ċelloli tad- demm li jikolagolaw) kif deskritt f’ sessjoni 3 (visti ta ’ wara l- kura)
- if you are breast-feeding (see section “ Pregnancy and breast-feeding”).
- jekk qed tredda ’ (ara sessjoni “ tqala u treddigħ ”).
Take special care with Siklos
Oqgħod attent ħafna b’ Siklos
- if you have liver disease
- jekk għandek mard tal- fwied -
- if you have leg ulcers
- jekk għandek ulċeri fis- saqajn
- if you are taking other myelosuppressive medicines (decrease production of red, white, or
- jekk qed tieħu prodotti mediċinali mijelosoppressivi oħra (inaqqsu l- produzzjoni ta ’ ċelloli ħomor,
coagulating blood cells) or receiving radiation therapy
20
- if you have a known lack of vitamin B12 or folate
- Jekk ghandek nuqqas magħaruf tal- vitamina B12 jew tal- folate.
If you experience (or have experienced) any of these, please tell your doctor.
Jekk ikollok esperjenza (jew kellek esperjenza) ta ’ xi wieħed/ waħda minn dawn, jekk jogħoġbok għid lit- tabib tiegħek.
Please inform your doctor or pharmacist if you are taking:
Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu:
- antiretroviral medicines (those that inhibit or destroy a retrovirus such as HIV), e. g. didanosine,
- mediċini antiretrovirali (dawk li jinibixxu jew jeqerdu retrovirus bħal HIV), e. ż. didanosine,
stavudine and indinavir (a median decline in some of your white blood cells called CD4 cells of approximately 100/ mm3 may occur.)
stavudine u indinavir (jista jseħħ tnaqqis medjan ta ’ bejn wieħed u iehor 100 / mm3 f’ xi wħud miċ - ċelloli bojod tad- demm tieghek li jissejħu ċelloli CD4)
- myelosuppressive medicines (decrease production of red, white, or coagulating blood cells) and
- mediċini mijelosoppressivi (inaqqsu l- produzzjoni ta ’ ċelloli ħomor, bojod jew ċelloli tad- demm li
radiation therapy
jikolagolaw) u terapija ta ’ radjazzjoni
- some vaccines (If you have doubts, please ask your pharmacist or your doctor).
- xi tilqim (jekk għandek xi dubji, jekk jogħġbok saqsi lit- tabib jew l- ispiżjar tiegħek).
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, even medicinal products obtained without a prescription.
Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
Taking Siklos with food and drink
Meta tieħu Siklos ma ’ l- ikel u max- xorb
Siklos should be taken in the morning before breakfast and, where necessary, with a glass of water or a very small amount of food to ensure optimal absorption.
Siklos għandu jittieħed filgħodu qabel il- kollazzjoni u, fejn hemm bżonn, ma ’ ammont żgħir ħafna ta ’ ikel, biex tiżgura l- aħjar assorbiment.
Siklos is not recommended during pregnancy.
Siklos mhux rakkomandat waqt it- tqala.
Women should be advised to use adequate birth control measures during treatment with hydroxycarbamide.
Nisa għandhom jingħataw parir biex jużaw miżuri ta ’ kontraċezzjoni adekwati waqt kura b’ hydroxycarbamide.
The use of effective contraception is strongly recommended.
L- użu ta ’ kontraċezzjoni effetiva hija rakkomandata ħafna.
If you become pregnant or plan to become pregnant while taking Siklos and for the male patients taking Siklos, if your partner becomes pregnant or plans to become pregnant, your doctor will discuss with you the potential benefits and risks of continuing Siklos.
Jekk toħroġ tqila jew qed tippjana li toħroġ tqila waqt li qed tieħu Siklos, u għall- pazjenti rġiel li qed jieħdu Siklos, jekk is- sieħba tiegħek toħroġ tqila jew qed tippjana li toħroġ tqila, it- tabib tiegħek se jiddiskuti miegħek il- benefiċċji u r- riskji possibbli jekk tkompli tieħu Siklos.
The active substance of Siklos passes into human breast-milk.
Is- sustanza attiva ta ’ Siklos tgħaddi fil- halib tas- sider tal- bniedem.
You must not breast-feed while taking Siklos.
M’ għandekx tredda ’ waqt li qed tieħu Siklos.
Dizziness is an uncommon side effect of Siklos.
Sturdament mhux effett sekondarju komuni ta ’ Siklos.
Do not drive or use any tools or machines if you experience dizziness whilst taking Siklos.
Issuqx u tużax għodda jew magni jekk tesperjenza sturdament meta tieħu Siklos.
HOW TO TAKE SIKLOS
KIF GĦANDEK TIEĦU SIKLOS
Handling Siklos is a medicine that must be handled with care.
Siklos huwa mediċina li għandha tiġi mmaniġġjata b’ attenzjoni.
Any person, in particular pregnant women, who are not taking Siklos should avoid to come in direct contact with the parts when breaking a tablet.
Kull persuna, speċjalment nisa tqal, li mhux qed jieħdu Siklos għandhom jevitaw li jiġu f’ kuntat dirett mal- biċċiet meta qed jaqsmu pillola.
Wash your hands before and after contact with the tablets.
Aħsel idejn qabel u wara kuntatt mal- pilloli.
In case the prescribed dosage requires breaking the tablet in halves or quarters, this should be done out of the reach of food.
F’ każ li d- doża preskritta tinħtieġ li l- pillola tinqasam f’ nofsijiet jew f’ erba ’ biċċiet, dan għandu jsir il - bogħod mil- ikel.
Powder spilled from the broken tablet should be wiped up with a damp disposable towel which is thrown out.
Trab imxerred mil- pillola maqsuma għandu jintmesaħ b’ xugaman tal- karta niedi li wara jintrema.