qanastek/EMEA-V3 huggingface dataset:
7 product as anti-erythropoietin antibodies cross-react with other erythropoietins.
Il- pazjenti m’ għandhomx jinbidlu għal fuq prodott ieħor peress li l- antikorpi anti- eritropojetini jirrejaġixxu ma ’ eritroptejini oħra.
Other causes of PRCA should be excluded, and appropriate therapy initiated.
Kawżi oħra ta ’ Pure Red Cell Aplasia għandhom jiġu esklużi, u għandha tingħata terapija kif suppost.
Monitoring of reticulocyte count on a regular basis is recommended to detect possible occurrence of lack of efficacy in chronic renal failure patients.
Il- monitoraġġ fuq bażi regolari ta ’ l- għadd tar- retikuloċiti huwa rrakomandat sabiex tiġi osservata okkorrenza possibli ta ’ nuqqas ta ’ effikaċja f’ pazjenti b’ insuffiċjenza renali kronika.
Hyperkalaemia has been observed in isolated cases.
Il- iperkalemija ġiet osservata f’ kazijiet iżolati.
In chronic renal failure patients, correction for anaemia may lead to increased appetite, and potassium and protein intake.
F’ pazjenti b’ insuffiċjenza renali kronika, korrezzjoni għall- anemija tista ’ twassal għal żieda fl- aptit, u t- teħidtal- potassju u l- proteini.
Dialysis prescriptions may have to be adjusted periodically to maintain urea, creatinine and potassium in the desired range.
Il- preskrizzjonijiet tad - dijalisi jistgħu jkollhom jiġu mibdula perjodikament sabiex l- ureja, il- krejatinina u l- potassju jinżammu fil- livell mixtieq.
Serum electrolytes should be monitored in chronic renal failure patients.
L- elettroliti fis- serum għandhom jiġu mmoniterjati f’ pazjenti b ’ insuffiċjenza renali kronika.
If an elevated (or rising) serum potassium level is detected then consideration should be given to ceasing erythropoietin administration until hyperkalaemia has been corrected.
Jekk livell elevat (jew qed qed jogħla) ta ’ potassju fis- serum jiġi osservat imbagħad għandha tingħata kunsiderazzjoni sabiex titwaqqaf l- amministrazzjoni tal- eritropojetin sakemm l- iperkalemija tkun ġiet irranġata.
An increase in heparin dose during haemodialysis is frequently required during the course of therapy with erythropoietin as a result of the increased packed cell volume.
Żieda fid- doża ta ’ l- eparina matul l- emodijalisi tkun neċessarja spiss matul il- kors tat- terapija bl - eritropojetin minħabba iż- żieda fil- volum ippakkjat taċ- ċelluli.
Occlusion of the dialysis system is possible if heparinisation is not optimum.
L- egħluq tas- sistema tad- dijalisi huwa possibbli jekk l- eparizzazzjoni mhux fl- aqwa tagħha.
Based on information available to date, correction of anaemia with erythropoietin in adult patients with renal insufficiency not yet undergoing dialysis does not accelerate the rate of progression of renal insufficiency.
Ibbażat fuq informazzjoni disponibbli sal- lum, il- korrezzjoni tal- anemija bl- eritroptejin f’ pazjenti adulti b’ insuffiċċjenza renali li għadhom ma bdewx id- dijalisi ma taċċellerax ir- rata tal- progress tal - insuffiċċjenza renali.
Adult cancer patients with symptomatic anaemia receiving chemotherapy
Pazjenti adulti tal- kanċer bl- anemija sinntomatika li qegħdn jirċievu l- kimoterapija
In cancer patients receiving chemotherapy, the 2-3 week delay between erythropoietin administration and the appearance of erythropoietin-induced red cells should be taken into account when assessing if Retacrit therapy is appropriate (patient at risk of being transfused).
F‘ pazjenti tal- kanċer li qegħdin jirċievu l- kimoterapija, id- dewmien ta ’ 2- 3 gimgħat bejn l - amministrazzjoni tal- eritropojetin u d- dehra ta ’ ċelluli ħomor ikkaġunati mil- eritropojetin għandu jitqies meta jiġi assessjat jekk it- terapija b’ Retacrit hijiex adattata (il- pazjent huwa f’ riskju li jiġi trasfuzjat).
Haemoglobin levels should be closely monitored until a stable level is achieved and periodically thereafter.
Il- livelli tal- emoglobina għandhom jiġu mkejla b’ mod regolari sakemm jintlaħaq livell stabbli u perjodikament wara.
If the rate of increase in haemoglobin exceeds 2 g/ dl (1.25 mmol/ l) per month or the haemoglobin level exceeds 12 g/ dl (7.5 mmol/ l), the dose adjustment detailed in section 4.2 should be thoroughly performed to minimise the risk of thrombotic events (see section 4.2).
Jekk ir- rata fiż- żieda tal- emoglobina taqbeż iż- 2 g/ dl (1. 25 mmol/ l) kull xahar jew il- livell tal- emoglobina jaqbeż it- 12 g/ dl (7. 5 mmol/ l), l- aġġustament tad- doża kif spjegata f - sezzjoni 4. 2 għandu jsir sabiex jitnaqqas ir- riskju ta ’ waqtiet trombotiċi (ara sezzjoni 4. 2).
As an increased incidence of thrombotic vascular events (TVEs) has been observed in cancer patients receiving erythropoietic agents (see section 4.8), this risk should be carefully weighed against the benefit to be derived from treatment (with Retacrit) particularly in cancer patients with an increased risk of thrombotic vascular events, such as obesity and patients with a prior history of TVEs (e. g. deep venous thrombosis or pulmonary embolism).
Trombożi venuża fonda jew emboliżmu pulmonarju).
Adult surgery patients in an autologous predonation programme
Pazjenti adulti li kellhom il- kirurġija f’ programm ta ’ pre- donazzjoni awtologa
All special warnings and precautions associated with autologous predonation programs, especially routine volume replacement, should be respected.
It- twissijiet u l- prekawzjonijiet speċjali assoċjati ma ’ programmi ta ’ pre- donazzjonijiet awtoloġi, speċjalment bdil ta ’ rutina fil- volum, għandhom jiġu rispettati.
Tumour growth potential
Il- potenzjal ta ’ tkabbir ta ’ tumur
Epoetins are growth factors that primarily stimulate red blood cell production.
L- epoetini huma fatturi ta ’ l- iżvilupp li prinċipalment jistimulaw il- produzzjoni ċ- ċelluli l- ħomor tad- demm.
Erythropoietin receptors may be expressed on the surface of a variety of tumour cells.
Ir- riċettaturi tal- eritropojetin jistgħu jiġu espressi fuq il- wiċċ ta ’ diversi ċelluli ta ’ tumuri.
As with all growth factors, there is a concern that epoetins could stimulate the growth of any type of malignancy.
Bħal fil- każ tal- fatturi ta ’ l- iżvilupp kollha, hemm tħassib li l- epoetini jistgħu jistimulaw l- iżvilupp ta ’ kwalunkwe tip ta ’ malinni.
In several controlled studies, epoetins have not been shown to improve overall survival or decrease the risk of tumour progression in patients with anaemia associated with cancer.
F’ diversi studji kontrollati, l- epoetini ma wrewx titjib fis- sopravivenza globali jew tnaqqis fir- riskju ta ’ firxa tat- tumuri f’ pazjenti b’ anemija assoċjata ma ’ kanser.
Several controlled clinical studies in which epoetins were administered to patients with a variety of common tumours including squamous head and neck cancer, lung cancer, and breast cancer, have shown an unexplained excess mortality.
9 Diversi studji kliniċi b’ kontrolli li saru li fihom l- epoetini ġew mogħtija lil pazjenti b’ diversi tipi ta ’ tumuri komuni li jinkludu kanser skwamuż tar- ras u l- għonq, kanser tal- pulmun, u l- kanser tas- sider urew mortalità eċċessiva mhux spjegabbli.
8 • shortened time to tumour progression in patients with advanced head and neck cancer receiving radiation therapy when administered to target a haemoglobin of greater than 14 g/ dl (8.7 mmol/ l), • shortened overall survival and increased deaths attributed to disease progression at 4 months in patients with metastatic breast cancer receiving chemotherapy when administered to target a haemoglobin of 12-14 g/ dl (7.5 -8.7 mmol/ l), increased risk of death when administered to target a haemoglobin of 12 g/ dl (7.5 mmol/ l) in patients with active malignant disease receiving neither chemotherapy nor radiation therapy.
Fi studji kliniċi b’ kontrolli, l- użu ta ’ Epoetin alfa u sustanzi oħra li jistimulaw eritropojesi (ESAs) urew: • żmien imqassar għal progressjoni tat- tumur fil- pazjenti b’ kanser tar- ras u ta ’ l- għonq avvanzat li qed jirċievu terapija ta ’ radjazzjoni meta jingħata biex jintaħaq livell ta ’ emoglobina ta ’ aktar minn 14 g/ dl (8, 7 mmol/ l). • tnaqqis fis- sopravivenza globali u żieda fl- imwiet attribwiti għal firxa tal- marda fi żmien 4 xhur f’ pazjenti b’ kanser metastatiku tas- sider li qed jirċievu kimoterapija meta jingħata biex jintlaħaq livell ta ’ emoglobina ta ’ 12- 14 g/ dl (7. 5 - 8. 7 mmol/ l), • żieda fir- riskju ta ’ mewt meta jingħata sabiex jintlaħaq livell mixtieq ta ’ emoglobina ta ’ 12 g/ dl (7. 5 mmol/ l) f’ pazjenti b’ mard malinn attiv li la qed jirċievu kimoterapija u lanqas terapija ta ’ radjazzjoni.
ESAs are not indicated for use in this patient population.
ESAs mhumiex indikati f’ din il- popolazzjoni ta ’ pazjenti.
The decision to administer recombinant erythropoietins should be based on a benefit-risk assessment with the participation of the individual patient, which should take into account the specific clinical context.
In vista ta ’ dak imsemmi hawn fuq, f’ xi sitwazzjonijiet kliniċi t- trasfużjoni tad- demm għandu jkun it- trattament ippreferut għal ġestjoni ta ’ anemija f’ pazjenti bil- kanċer, Id- deċiżjoni sabiex jiġu amministrati eritropoijetini għandha ttieħed fuq bażi tal- istima dwar is- siwi - riskju bil- partiċipazzjoni tal- pazjent individwali, b’ konsiderazzjoni għal kuntest kliniku speċifiku.
Factors that should be considered in this assessment should include the type of tumour and its stage; the degree of anaemia; life- expectancy; the environment in which the patient is being treated; and patient preference (see section 5.1)
Fatturi li għandhom jiġu kkonsidrati f’ din l- istima għandhom jinkludu t- tip ta ’ tumur u l- istadju li jkun wasal fih; il- grad tal - anemija; kemm mistennija tgħix persuna; l- ambjent fejn il- pazjent qed jiġi trattat; u l- preferenza tal - pazjent (ara sezzjoni 5. 1).
There is no evidence to indicate that treatment with erythropoietin alters the metabolism of other medicinal products.
Ma teżistix evidenza li tindika li t- trattament bl- eritropojetin ibiddel il- metaboliżmu ta ’ prodotti mediċinali oħra.
However, since ciclosporin is bound by red blood cells there is potential for interactions with other medicinal products.
Madankollu, peress li ċ- ċiklosporin huwa marbut b’ ċelloli ħomor tad- demm hemm potenzjal ta ’ interazzjonijiet ma ’ prodotti mediċinali oħra.
If erythropoietin is given concomitantly with ciclosporin, blood levels of ciclosporin should be monitored and the dose of ciclosporin adjusted as the haematocrit rises.
Jekk l- eritropojetin jingħata b’ mod konkomitanti maċ - ċiklosporin, il- livelli tad- demm taċ- ċiklosporin għandhom jiġu moniterjati u d- doża taċ- ċiklosporin aġġustata waqt li l- ematokrit jogħla.
No evidence exists that indicates an interaction between epoetin alfa and G-CSF or GM-CSF with regard to haematological differentiation or proliferation of tumour biopsy specimens in vitro.
Ma teżistix evidenza li tindika interazzjoni bejn epoetin alfa u G- CSF jew GM- CSF fir- rigward ta ’ ddifferenzjar ematoloġiku jew il- proliferazzjoni ta ’ kampjuni ta ’ bijopsiji tat- tumuri in vitro.
There are no adequate and well-controlled studies in pregnant women.
M’ hemmx studji adegwati u kontrollati tajjeb f’ nisa tqal.
Studies in animals have shown reproduction toxicity (see section 5.3).
L- istudji fl- annimali urew tossiċità ta ’ riproduzzjoni (ara sezzjoni 5. 3).
Consequently, erythropoietin should generally be used during pregnancy and lactation only if the potential benefit outweighs the potential risk to the foetus.
Minħabba f’ hekk, l- eritropojetin għandu jiġi użat ġeneralment matul it- tqala u treddigħ sakemm il- benfiċċju potenzjali jegħleb ir- riskju potenzjali fil- fetu.
Retacrit has no or negligible influence on the ability to drive and use machines.
Retacrit m’ għandux jew għandu ftit li xejn effett fuq il- ħila biex issuq u tħaddem magni.
Retacrit is a biological medicinal product.
Retacrit huwa prodott mediċinali bijoloġiku.
Data from clinical studies with Retacrit are in line with the safety profile of other authorized erythropoietins.
Data minn studji kliniċi b’ Retacrit huma simili fil- profil tas- sigurtà ma ’ erythropojetini awtorizzati oħra.
Based on the results from clinical trials with other authorized erythropoietins approximately 8% of patients treated with erythropoietin are expected to experience adverse reactions.
Ibbażat fuq ir- riżultati minn provi kliniċi b’ eritropojetini awtorizzati oħra, bejn wieħed u ieħor 8% tal- pazjenti li huma ttrattati bl- eritropojetin huma mistennija li juru reazzjonijiet avversi.
Undesirable effects during treatment with erythropoietin are observed predominantly in patients with chronic renal failure or underlying malignancies.
Effetti mhux mixtieqa matul it- trattament bl- eritropojetin jidhru bi predominanza f’ pazjenti b’ insuffiċjenza renali kronika jew kundizzjonijiet malinni.
These undesirable effects are most commonly headache and a dose dependent increase in blood pressure.
L- effetti mhux mixtieqa l- aktar komuni huma uġigħ ta ’ ras u żieda fil- pressjoni tad- demm li tiddependi mid - doża.
Hypertensive crisis with encephalopathy-like symptoms can occur.
Għandha tingħata
Attention should be paid to sudden stabbing migraine-like headaches as a possible warning signal.
10 attenzjoni għal uġigħ ta ’ ras qawwi f’ daqqa li jixbah lill- emigranja, bħala sinjal possibbli ta ’ twissija.
General Non-specific skin rashes have been described with epoetin alfa.
Raxxijiet tal- ġilda mhux speċifiċi ġew deskritti b’ rabta ma ’ epoetin alfa.
9 Thrombocytosis has been observed but its occurrence is very rare (see section 4.4).
Kienet osservata tromboċitożi iżda l- okkorrenza tagħha hija rari ħafna (ara sezzjoni 4. 4).
Thrombotic/ vascular events, such as myocardial ischaemia, myocardial infarction, cerebrovascular accidents (cerebral haemorrhage and cerebral infarction), transient ischaemic attacks, deep vein thrombosis, arterial thrombosis, pulmonary emboli, aneurysms, retinal thrombosis, and clotting of an artificial kidney have been reported in patients receiving erythropoietic agents.
Episodji trombotiċi/ vaskulari, bħal iskemija mijokardijaka, infart mijokardijaku, inċidenti ċerebrovaskulari (emorraġija ċerebrali u infart ċerebrali), attakki iskemiċi temporanji, trombożi tal - vini profonda, trombożi arterjali, emboli pulmonari, anewriżmi, trombożi fir- retina, u tagħqid ta ’ demm f’ kilwa artifiċjali kienu rrappurtati f’ pazjenti li kienu qed jirċievu sustanzi eritropojetiċi.
Hypersensitivity reactions have been rarely reported with epoetin alfa including isolated cases of angioedema and anaphylactic reaction.
Reazzjonijiet ta ’ sensittività eċċessiva kienu rrappurtati f’ każijiet rari b’ epoetin alfa, inklużi każijiet iżolati ta ’ anġoedema u reazzjoni anafilattika.
In most of these patients, antibodies to erythropoietins have been observed (see sections 4.3 and 4.4)
Fil- maġġoranza ta ’ dawn il- pazjenti, kienu osservati antikorpi għall - eritropojetini (ara sezzjoni 4. 3 u 4. 4).
Adult and paediatric haemodialysis patients, adult peritoneal dialysis patients and adult patients with renal insufficiency not yet undergoing dialysis
Pazjenti adulti u pedjatriċi fuq l- emodijalisi, pazjenti adulti fuq l- emodijalisi peritonali u pazjenti adulti b’ insuffiċjenza tal- kliewi li għadhom mhux qegħdin fuq id- dijalisi
Particular attention should be paid to sudden stabbing migraine like headaches as a possible warning signal.
Għandha tingħata attenzjoni partikulari għall- uġigħ ta ’ ras qawwi f’ daqqa li jixbah lill- emigranja, bħala sinjal possibbli ta ’ twissija.
An increased incidence of thrombotic vascular events (see section 4.4 and section 4.8 - General) has been observed in patients receiving erythropoietic agents.
Inċidenza akbar ta ’ episodji trombotiċi vaskulari (ara sezzjoni 4. 4 u sezzjoni 4. 8 – Ġenerali) kienet osservata f’ pazjenti li kienu qed jirċievu mediċini eritropojetiċi.
Surgery patients in autologous predonation programmes
Pazjenti kirurġiċi f’ programmi ta ’ pre- donazzjoni awtologi
Independent of erythropoietin treatment, thrombotic and vascular events may occur in surgical patients with underlying cardiovascular disease following repeated phlebotomy.
Indipendentament mit- trattament bl- eritropojetin, episodji trombotiċi u vaskulari jistgħu jseħħu f’ pazjenti kirurġiċi b’ mard kardjovaskulari wara flebotomija ripetuta.
Therefore, routine volume replacement should be performed in such patients.
Għalhekk, għandu jkun hemm tibdil ta ’ rutina fil- volum f’ dawn il- pazjenti.
Overdose of erythropoietin may produce effects that are extensions of the pharmacological effects of the hormone.
4. 9 Doża eċċessiva
Phlebotomy may be performed if excessively high haemoglobin levels occur.
Il- flebotomija tista ’ issir jekk ikun hemm livelli għoljin tal- emoglobina.
Additional supportive care should be provided as necessary.
Għajnuna addizzjonali supportiva għandha tingħata fejn hu meħtieġ.
Antianaemic preparations, erythropoietin ATC code:
Kategorija farmakoterapewtika: preparazzjonijiet antianemiċi, eritropojetin Kodiċi ATC:
Erythropoietin is a glycoprotein that stimulates, as a mitosis-stimulating factor and differentiating hormone, the formation of erythrocytes from precursors of the stem cell compartment.
L - eritropojetin hija glikoproteina li tistimola, bħala fattur mitosi- stimulanti u ormon differenzjat, il - formazzjoni ta ’ eritroċiti minn prekursuri tal- kompartiment taċ- ċellula mhux differenzjata.
The apparent molecular weight of erythropoietin is 32,000-40,000 Dalton.
Il- massa molekulari apparenti ta ’ eritropojetin hija ta ’ 32000- 40000 Dalton.
The protein moiety of the molecule contributes about 58% of total molecular weight and consists of 165 amino acids.
Il- parti magħmula mill - proteina tikkontribwixxi xi 58% tal- massa totali u tikkonsisti minn 165 aċidi aminiċi.
The four carbohydrate chains are attached via three N-glycosidic bonds and one O-glycosidic bond to the protein.
L- erba ’ ktajjen ta ’ karboidrati huma imqabbda permezz ta ’ tliet rabtiet ta ’ N- glycosidic u rabta waħda ta ’ O- glycosidic mal - proteina.
Epoetin zeta is identical in its amino acid sequence and similar in carbohydrate composition to endogenous human erythropoietin that has been isolated from the urine of anaemic patients.
L- Epoetin zeta huwa identiku fis- sekwenza tal- aċidi aminiċi tiegħu u l- kompozizzjoni ta ’ karboidrati hija simili għall- eritropojetin indiġinu uman li ġie iżolat mill- urina ta ’ pazjenti anemiċi.
The biological efficacy of erythropoietin has been demonstrated in various animal models in vivo (normal and anaemic rats, polycythaemic mice).
l- efikaċija bijoloġika tal- eritropojetin intweriet f’ diversi mudelli ta ’ l- annimali in vivo (ġrieden normali u anemiċi, ġrieden polycythaemic).
After administration of erythropoietin, the number of erythrocytes, the Hb values and reticulocyte counts increase as well as the 59Fe-incorporation rate.
Wara l- amministrazzjoni tal- eritropojetin, in- numru tal- eritroċiti, il- valuri tal- Hb u l- għadd ta ’ retikuloċiti jiżdiedu, wkoll bħar- rata inkorporata tal- 59Fe.
An increased 3H-thymidine incorporation in the erythroid nucleated spleen cells has been found in vitro (mouse spleen cell culture) after incubation with erythropoietin.
Żieda fl- inkorporazzjoni tal- 3H- thymidine fiċ- celluli eritrojdi nukleati tal- milsa instab in vitro (kultura ta ’ cellula tal- milsa tal- ġurdien) wara inkubazzjoni bl- eritropojetin.
It could be shown with the aid of cell cultures of human bone marrow cells that erythropoietin stimulates erythropoiesis specifically and does not affect leucopoiesis.
Jista ’ jintwera bl- għajnuna ta ’ kulturi ta ’ ċelluli miċ- ċelluli tal- mudullun uman li l- eritropojetin jistimula speċifikament l - erythropoiesis u ma jaffettwax l- leucopoiesis.
Cytotoxic actions of erythropoietin on bone marrow cells could not be detected.
L- azzjonjiet ċitotossiċi tal- eritropojetin fuq iċ- ċelluli tal - mudullun ma setgħux jiġu osservati.
As with other haematopoietic growth factors, erythropoietin has shown in vitro stimulating properties on human endothelial cells.
Bħall- fatturi oħra ta ’ tkabbir haematopoietic, l- eritropojetin wera in vitro propretajiet stimilanti fuq ċelluli endoteljali.
721 cancer patients receiving non-platinum chemotherapy were included in three placebo-controlled studies, 389 patients with haematological malignancies (221 multiple myeloma, 144 non-Hodgkin's lymphoma, and 24 other haematological malignancies) and 332 with solid tumours (172 breast, 64 gynaecological, 23 lung, 22 prostate, 21 gastrointestinal, and 30 other tumour types).
721 pazjent tal- kanċer li qegħdin jirċievu kimoterapija mhux tal- platinu ġew inklużi fi tliet studji plaċebo- kontrollati, 389 pazjent b ’ kankri ematoloġiċi mallinni (221 myeloma multipla, 144 non- Hodgkin' s lymphoma, u 24 kankri mallinni ematoloġici oħra) u 332 b’ tumuri solidi (172 tas- sider, 64 ġinekoloġiku, 23 tal- pulmun, 22 prostata, 21 gastro- intestinali, u 30 tip ieħor ta ’ tumuri).
In two large, open-label studies, 2697 cancer patients receiving non-platinum chemotherapy were included, 1895 with solid tumours (683 breast, 260 lung, 174 gynaecological, 300 gastrointestinal, and 478 other tumour types) and 802 with haematological malignancies.
F’ żewġ studji kbar bit- tikketti miftuħa (open label), 2697 pazjent tal- kanċer li qegħdin jirċievu kimoterapija mhux tal- platinu ġew inklużi, 1895 b’ tumuri solidi (683 tas- sider, 260 tal- pulmun, 174 ġinekoloġiku, 300 gastro- intestinali, u 478 tipi oħra ta ’ tumri) u 802 b’ kankri mallinni emotalogiċi.
In a prospective, randomised, double-blind, placebo-controlled trial conducted in 375 anaemic patients with various non-myeloid malignancies receiving non-platinum chemotherapy, there was a significant reduction of anaemia-related sequelae (e. g. fatigue, decreased energy, and activity reduction), as measured by the following instruments and scales:
F’ prova prospettiva, randomised, double- blind, plaċebo- kontrollata magħmula fi 375 pazjent anemiċi b’ kankri mallinni varji mhux myeloid li qed jirċievu l- kimoterapija mhux tal- platinu, kien hemm tnaqqis sinjifikanti ta ’ sequelae relatati ma ’ l- anemija (eż. l- għejja, nuqqas ta ’ enerġija, u nuqqas ta ’ attività), kif imkejjel mill- istrumenti u skali li ġejjin:
Functional Assessment of Cancer Therapy-Anaemia (FACT-An) general scale, FACT-An fatigue scale, and Cancer Linear Analogue Scale (CLAS).
Functional Assessment of Cancer Therapy- Anaemia (FACT- An) skala ġenerali, FACT- An skala ta ’ l- għejja, u Skala tal- Kanċer Linejari Anologu (CLAS).
Two other smaller, randomized, placebo-controlled trials failed to show a significant improvement in quality of life parameters on the EORTC-QLQ-C30 scale or CLAS, respectively.
Żewġ provi oħra żgħar, randomised plaċebo- kontrollati urew titjib sinjifikanti fil - kwalità tal- parameteri tal- ħajja fuq l- iskala EORTC- QLQ- C30 jew il- CLAS, rispettivament.
Erythropoietin is a growth factor that primarily stimulates red cell production.
L- eritropojetin huwa fattur ta ’ l- iżvilupp li prinċipalment jistimola l- produzzjoni taċ- ċelloli ħomor.
Erythropoietin receptors may be expressed on the surface of a variety of tumour cells.
Ir - reċetturi ta ’ l- eritropojetin jistgħu jiġu espressi fuq il- wiċċ ta ’ varjetà ta ’ ċelluli tat- tumuri.
Survival and tumour progression have been examined in five large controlled studies involving a total of 2833 patients, of which four were double-blind placebo-controlled studies and one was an open- label study.
Is- sopravivenza u l- firxa ta ’ tumuri ġew eżaminati f’ ħames studji kbar b’ kontrolli li kienu jinvolvu total ta ’ 2833 pazjent, li minnhom erba ’ kienu studji double- blind bi plaċebo bħala kontrolli u wieħed kien bit- tikketta tingħaraf.
The studies either recruited patients who were being treated with chemotherapy (two studies) or used patient populations in which erythropoiesis stimulating agents are not indicated: anaemia in patients with cancer not receiving chemotherapy, and head and neck cancer patients receiving radiotherapy.
12 indikati: anemija f’ pazjenti bil- kanser li ma kienux qed jirċievu kimoterapija, u pazjenti b’ kanser fir ras u fil- għonq li kienu qed jirċievu radjoterapija.
The target haemoglobin concentration in two studies was > 13 g/ dl; in the remaining three studies it was 12-14 g/ dl.
Il- konċentrazzjoni ta ’ emoglobina immirata f’ żewġ studji kienet ta ’ > 13 g/ dl; fit- tliet studji li baqa ’ kienet ta ’ bejn 12- 14 g/ dl.
In the open-label study there was no difference in overall survival between patients treated with recombinant human erythropoietin and controls.
Fl- istudju bit- tikketta tingħaraf ma kien hemm ebda differenza fis- sopravivenza globali fost pazjenti trattati b’ eritropojetin rikombinanti uman u l- kontrolli.
These studies have shown a consistent unexplained statistically significant excess
Fl- erba ’ studji bi plaċebo bħala kontroll il- proporzjonijiet ta ’ ħsara għal sopravivenza globali kienet tvarja bejn 1. 25 u 2. 47 favur il- kontrolli.
11 mortality in patients who have anaemia associated with various common cancers who received recombinant human erythropoietin compared to controls.
Dawn l- istudji wrew mortalità eċċessiva konsistenti statistikament sinifikanti u bla spjegazzjoni f’ pazjenti li għandhom anemija assoċjata ma diversi kansers komuni li rċevew eritropojetin rikombinanti uman meta mqabbel ma ’ kontrolli.
Overall survival outcome in the trials could not be statisfactorily explained by differences in the incidence of thrombosis and related complications between those given recombinant human erythropoietin and those in the control group.
Ir- riżultati ta ’ sopravivenza globali f’ dawn il- provi ma setgħux jiġu spjegati b’ mod sodisfaċenti bid- differenzi fl- inċidenza ta ’ trombożi u kumplikazzjonijiet relatati bejn dawk li jingħataw eritropojetin rikombinanti uman u dawk fil- grupp tal- kontroll
A systematic review has also been performed involving more than 9000 cancer patients participating in 57 clinical trials.
Reviżjoni sistematika ġiet mwettqa wkoll fuq aktar minn 9000 pazjent bil - kanċer li kienu qed jipparteċipaw f’ 57 prova klinika.
Meta-analysis of overall survival data produced a hazard ratio point estimate of 1.08 in favour of controls (95% CI:
Meta- analiżi ta ’ l- informazzjoni dwar is- sopravivenza globali tat stima ta ’ punt ta ’ proporzjon ta ’ periklu ta ’ 1. 08 favur il- kontrolli (- 95% CI:
0.99, 1,18; 42 trials and 8167 patients).
0. 99, 1, 18; 42 prova u 8167 pazjent).
An increased relative risk of thromboembolic events (RR 1.67, 95% CI:
Riskju relattiv ogħla ta ’ każijiet tromboembolitiċi (RR 1. 67, 95% CI:
1.35, 2.06, 35 trials and 6769 patients) was observed in patients treated with recombinant human erythropoietin.
1. 35, 2. 06, 35 prova u 6769 pazjent) kien osservat f’ pazjenti fuq eritropojetin rikombinanti uman.
There is an increased risk for thromboembolic events in patients with cancer treated with recombinant human erythropoietin and a negative impact on overall survival cannot be excluded.
Hemm riskju ogħla għal każijiet tromboemboliċi f’ pazjenti b’ kanser ittrattati b’ eritropojetin rikombinanti uman u impatt negattiv fuq is- sopravivenza globali ma tistax tiġi eskluża.
The extent to which these outcomes might apply to the administration of recombinant human erythropoietin to patients with cancer, treated with chemotherapy to achieve haemoglobin concentrations less than 13 g/ dl, is unclear because few patients with these characteristics were included in the data reviewed.
Il- firxa li għalihom riżultati bħal dawn jistgħu japplikaw għall- għoti ta ’ eritropojetin rikombinanti uman għal pazjenti b ’ kanċer, ittrattati b’ kimoterapija sabiex jintlaħqu konċentrazzjonijiet tal- emoglobina, ta ’ inqas minn 13 g/ dl, mhix ċara peress li kienu ftit il- pazjenti b’ dawn il- karatteristiċi li kienu inklużi fid- dejta riveduta.
Intravenous route Measurement of erythropoietin following multiple dose intravenous administration revealed a half-life of approximately 4 hours in healthy volunteers and a somewhat more prolonged half-life of approximately 5 hours in renal failure patients.
Ir- rotta ġol- vina Il- kejl ta ’ l - eritropojetin wara dożi multipli amministrati ġol- vini juru half- life ta ’ bejn wieħed u ieħor 4 sigħat f’ voluntiera b’ saħħithom u half- life kemm xejn aktar twila f’ pazjenti b’ insuffiċjenza renali, ta ’ bejn wieħed u ieħor 5 sigħat.
A half-life of approximately 6 hours has been reported in children.
Half- life ta ’ bejn wieħed u ieħor 6 sigħat ġiet irrapurtata fit- tfal.
Subcutaneous route Following subcutaneous injection, serum levels of erythropoietin are much lower than the levels achieved following intravenous injection, the levels increase slowly and reach a peak between 12 and 18 hours postdose.
Ir- rotta taħt il- ġilda Wara injezzjoni taħt il- ġilda, il- livelli tas- serum tal- eritropojetin huma ħafna anqas mil- livelli milħuqa wara l- injezzjoni ġol- vini, bil- livelli jiżdiedu bil- mod u jilħqu l- ogħla punt bejn it- 12 u t- 18- il - siegħa wara id- doża.
The peak is always well below the peak achieved using the intravenous route (approximately 1/ 20th of the value).
L- ogħla punt huwa ferm anqas mill- ogħla punt miksub bl- użu tar- rotta IV (bejn wieħed u ieħor 1 f’ kull 20 tal- valur).
There is no accumulation: the levels remain the same, whether they are determined 24 hours after the first injection or 24 hours after the last injection.
M’ hemmx akkumulazzjoni: il- livelli jibqgħu l- istess, kemm jekk huma determinati 24 siegħa wara l - ewwel injezzjoni sew jekk 24 siegħa wara l- aħħar injezzjoni.
The half-life is difficult to evaluate for the subcutaneous route and is estimated to be about 24 hours.
Hija diffiċli li tevalwa half- life għar- rotta ta ’ taħt il- ġilda u hu stmat li hija madwar 24 siegħa.
The bioavailability of subcutaneous injectable erythropoietin is much lower than that of the intravenous medicinal product and is approximately 20%.
Il - bijodisponibilità tal- eritropojetin injettat taħt il- ġilda hija ħafna aktar baxxa minn dik tal- prodott mediċinali injettat ġol- vini u hijabejn wieħed u ieħor 20%.
In some pre-clinical toxicological studies in dogs and rats, but not in monkeys, erythropoietin therapy was associated with subclinical bone marrow fibrosis (bone marrow fibrosis is a known complication of chronic renal failure in humans and may be related to secondary hyperparathyroidism or unknown factors.
F’ xi studji tossikoloġiċi ta ’ qabel l- użu kliniku fil- klieb u l- ġrieden, iżda mhux fix- xadini, it- terapija bl- eritropojetin kienet assoċjata ma ’ fibrożi sottoklinika tal- mudullun (il- fibrożi tal- mudullun hija kumplikazzjoni magħrufa ta ’ insuffiċjenza renali kronika fl- umani u tista ’ tkun relatata mal - hyperparathyroidism sekondarju jew fatturi mhux magħrufa.
The incidence of bone marrow fibrosis was not increased in a study of haemodialysis patients who were treated with erythropoietin for 3 years compared to a matched control group of dialysis patients who had not been treated with erythropoietin).
L- inċidenza tal- fibrożi tal- mudullun ma żdieditx fi studju ta ’ pazjenti tal- emodijalisi li kienu ġew ittratati bl- eritropojetin għal 3 snin meta mqabbla ma ’ grupp ta ’ kontroll ta ’ pazjenti bid- dijalisi li ma kienux ġew ittratati bl- eritropojetin).
In animal studies, erythropoietin has been shown to decrease foetal body weight, delay ossification and increase foetal mortality when given in weekly doses of approximately 20 times the recommended human weekly dose.
Fl- istudji tal- annimali, intwera li l- eritropojetin naqqas it- piż tal- ġisem tal- fetu, dewwem l - ossifikazzjoni u żied il- mortalità fil- fetu meta fil- ġimgħa ingħataw dożi ta ’ bejn wieħed u ieħor 20 darba id- doża rakkomandata fil- bniedem fil- ġimgħa.
These changes are interpreted as being secondary to decreased maternal body weight gain.
Dawn it- tibdiliet huma interpretati li huma sekondarji għan- nuqqas fiż- żieda fil- piż tal- ġisem tal- omm.
Erythropoietin did not show any changes in bacterial and mammalian cell culture mutagenicity tests and an in vivo micronucleus test in mice.
13 mammiferi u studji mikronukleji in vivo fi- ġrieden.
Long-term carcinogenicity studies have not been carried out.
Studji karċenoġenetiċi fit- tul ma sarux.
There are conflicting reports in the literature regarding whether erythropoietin may play a major role as tumour proliferator.
Hemm rapporti konflittwali fil- letteratura dwar jekk l- eritropojetin jistax ikollu rwol ewlieni bħala proliferatur ta ’ tumuri.
These reports are based on in vitro findings from human tumour samples, but are of uncertain significance in the clinical situation.
Dawn ir- rapporti huma bbażati fuq sejbiet in vitro minn kampjuni ta ’ tumur uman, iżda huma ta ’ sinjifikanza mhix ċerta fis- sitwazzjoni klinika.
Disodium phosphate dihydrate Sodium dihydrogen phosphate dihydrate Sodium chloride Calcium chloride dihydrate Polysorbate 20 Glycine Leucine Isoleucine Threonine Glutamic acid Phenylalanine Water for injections Sodium hydroxide (pH adjuster) Hydrochloric acid (pH adjuster)
Disodium phosphate dihydrate Sodium dihydrogen phosphate dihydrate Sodium chloride Calcium chloride dihydrate Polysorbate 20 Glycine Leucine Isoleucine Threonine Glutamic acid Phenylalanine Water for injections Sodium hydroxide (għal aġġustament tal- pH) Hydrochloric acid (għal aġġustament tal- pH)
For the purpose of ambulatory use, the patient may remove the product from the refrigerator and store it at room temperature (not above 25°C) for one single period of up to 3 days.
Għall- skop ta ’ użu ambulatorju, il- pazjent jista ’ jneħħi l- prodott mill- friġġ u jżommu f’ temperatura ambjentali (mhux aktar minn 25°C), għall- perjodu wieħed ta ’ mhux aktar minn tlett ijiem.
Pre-filled syringe Type I glass with a fixed steel injection needle and a plunger stopper with PTFE coating.
Is- siringa mimlija minn qabel tal- ħġieġ tat- Tip I b’ labra fissa tal- ħadid u b’ tapp b’ kisja ta ’ PTFE.
Each pre-filled syringe contains 0.3 ml solution for injection.
Kull siringa mimlija minn qabel fiha 0. 3 ml ta ’ soluzzjoni għall- injezzjoni.
Each pack contains 1 or 6 pre-filled syringes.
Kull pakett għandu 1 jew 6 siringi mimlija minn qabel.
Handling instructions for Retacrit:
Struzzjonjiet tal- immaniġjar ta ’ Retacrit:
After removing one syringe from the blister pack the solution should be checked to ensure that it is clear, colourless and practically free from visible particles.
Wara li tneħħi siringa waħda mill- pakkett is- soluzzjoni għandha tiġi eżaminata li hi ċara, bla kulur u prattikament ħielsa minn partiċelli viżibbli.
The protective cap is removed from the injection needle and air is expelled from the syringe and needle by holding the syringe vertically and gently pressing the plunger upwards.
It- tapp protettiv jitneħħa mil- labra tas- siringa and l- arja titneħħa mis- siringa u l- labra billi
The syringe is now ready for use.
Is- siringa hija issa lesta biex tintuża.
Retacrit must not be used if • The blister sealing is broken or the blister is damaged in any way. • The liquid is coloured or you can see particles floating in it. • Any liquid has leaked out of the pre-filled syringe or condensation is visible within the sealed blister. • It may have been accidentally frozen.
Retacrit m’ għandux jintuża jekk • Is- siġill trasparenti jitkisser jew il- blister huwa b’ xi mod imħassar • Il- likwidu huwa kkulurit jew tista ’ tara l- partiċelli jgħumu fih • Jekk xi likwidu ħareġ mis- siringa mimlija minn qabel jew hija viżibbli l- kondensazzjoni fil - pakkett issiġġillat • Jista ’ ikun li kien ffriżat bi żball
This medicinal product is for single use only.
Il- prodott mediċinali għandu jintuża darba biss.
Taurusavenue 19-21 NL-2132 LS HOOFDDORP The Netherlands
Taurusavenue 19- 21 NL- 2132 LS HOOFDDORP L- Olanda
Retacrit 2000 IU/ 0.6ml solution for injection in pre-filled syringe
Retacrit 2000 IU/ 0. 6 ml soluzzjoni għall- injezzjoni f’ siringa mimlija minn qabel
1 pre-filled syringe with 0.6 ml solution for injection contains 2000 international units (IU) epoetin zeta* (recombinant human erythropoietin).
Siringa waħda mimlija minn qabel b’ 0. 6 ml soluzzjoni għall- injezzjoni għandha 2000 unit internazzjonali (IU) epoetin zeta * (rikombinanti uman erythropoietin).
Each pre-filled syringe contains 0.30 mg phenylalanine.
Kull siringa mimlija minn qabel fiha 0. 30 mg p fenilalanin.
Treatment of symptomatic anaemia in adult and paediatric chronic renal failure patientsIn patients with chronic renal failure the medicinal product has to be administered intravenously (see section 4.4)
F’ pazjenti b’ falliment renali kroniku l- prodott mediċinali għandu jingħata minn ġol- vina (ara sezzjoni 4. 4)
15 The haemoglobin concentration aimed for is between 10 and 12 g/ dl (6.2-7.5 mmol/ l), except in paediatric patients in whom the haemoglobin concentration should be between 9.5 and 11 g/ dl (5.9-6.8 mmol/ l).
16 Il- konċentrazzjoni tal- emoglobina mixtieqa għandha tkun ta ’ bejn 10 u 12 g/ dl (6. 2- 7. 5mmol/ l) ħlief f’ pazjenti tfal fejn il- konċentrazzjoni tal- emoglobina għandha tkun bejn 9. 5 u 11 g/ dl (5. 9- 6. 8 mmol/ l).
Dose (IU/ kg given 3x week)
17 Doża (UI/ kg mogħtija 3x fil- ġimgħa)
16 The clinical data available suggest that those patients whose initial haemoglobin is very low (< 6.8 g/ dl or< 4.25 mmol/l) may require higher maintenance doses than those whose initial haemoglobin is higher > 6.8 g/dl or> 4.25 mmol/l).
Id- data klinika provduta tagħti x’ tifhem li dawk il- pazjenti li l- emoglobina inizjali tagħhom hija baxxa ħafna (< 6. 8 g/ dl jew < 4. 25 mmol/ l) jista ’ jkun li jkollhom bżonn dożi ta ’ manteniment ogħla minn dawk li l- emoglobina inizjali tagħhom hija ogħla minn > 6. 8 g/ dl jew > 4. 25 mmol/ l).
Treatment of patients with chemotherapy induced anaemia Retacrit should be administered by the subcutaneous route to patients with anaemia (e. g. haemoglobin concentration ≤ 10 g/ dl (6.2 mmol/ l).
Retacrit jista ’ jingħata taħt il- ġilda lil pazjenti b’ anemija (eż. konċentrazzjoni tal- emoglobina ≤ 10 g/ dl (6. 2 mmol/ l).
If the haemoglobin has increased by at least 1 g/ dl (0.62 mmol/ l) or the reticulocyte count has increased ≥ 40,000 cells/ µl above baseline after 4 weeks of treatment, the dose should remain at 150 IU/ kg 3 times per week or 450 IU/ kg once weekly.
18 Jekk l- emoglobina żdiedet b’ minn ta ’ l- anqas 1 g/ dl (0. 62 mmol/ l) jew l- għadd tar- retikoloċiti żdiedet ≥ 40000 ċelluli/ µl ‘ il- fuq mil- linja bażi wara 4 ġimgħat ta ’ trattament, id- doża għanda tibqa ’ ta ’ 150 IU/ kg 3 darbiet fil- ġimgħa jew 450 IU/ kg darba fil- ġimgħa.
If the haemoglobin increase is < 1 g/ dl (< 0.62 mmol/ l) and the reticulocyte count has increased < 40,000 cells/ µl above baseline, increase the dose to 300 IU/ kg 3 times per week.
Jekk iż- żieda fl- emoglobina hija < 1 g/ dl (< 0. 62 mmol/ l) u l- għadd tar- retikoloċiti żdied < 40000 ċelluli/ µl ‘ il fuq mil- inja bażi, żid id- doża għal 300 IU/ kg 3 darbiet fil- ġimgħa.
If after an additional 4 weeks of therapy at 300 IU/ kg 3 times per week, the haemoglobin has increased ≥ 1 g/ dl (0.62 mmol/ l) or the reticulocyte count has increased ≥ 40,000 cells/ µl the dose should remain at 300 IU/ kg 3 times per week.
Jekk wara 4 ġimgħat oħra ta ’ terapija ta ’ 300 IU/ kg 3 darbiet fil - ġimgħa, l- emoglobina żdiedet ≥ 1 g/ dl (0. 62 mmol/ l) jew l- għadd tar- retikoloċiti żdied ≥ 40000 ċelluli/ µl id- doża għanda tibqa ’ ta ’ 300 IU/ kg 3 darbiet fil- ġimgħa.
However, if the haemoglobin has increased < 1 g/ dl (< 0.62 mmol/ l) and the reticulocyte count has increased < 40,000 cells/ µl above baseline, response is unlikely and treatment should be discontinued.
Madankollu, jekk l- emoglobina żdiedet < 1 g/ dl (< 0. 62 mmol/ l) u l- għadd tar- retikoloċiti żdied < 40000 ċelluli/ µl il fuq mil- linja bażi, ir- rispons huwa dubjuż u t- trattament m’ għandux jitkompla.
The recommended dosing regimen is described in the following diagram:
Il- kors ta ’ dożaġġ rakkomandat huwa deskritt fid- dijagramma li ġejja:
Appropriate dose titration should be considered.
19 150 IU/ kg 3x/ ġimgħa jew 450 IU/ kg darba fil- ġimgħa
Dose adjustment At a rate of rise in haemoglobin of > 2 g/ dl (> 1.25 mmol/ l) per month the Retacrit dose should be reduced by about 25-50%.
Żieda fl- għadd ta ’ retikuloċiti ≥ 40, 000/ μl jew żieda fl- Hb ≥ 1 g/ d
If haemoglobin level exceeds 12 g/ dl (7.5 mmol/ l), discontinue therapy until it falls to 12 g/ dl (7.5 mmol/ l) or lower and then reinstitute Retacrit therapy at a dose 25% below the previous dose.
Żieda fl- għadd ta ’ retikuloċiti < 40, 000/ μl u żieda fl- Hb < 1 g/ dl
− Adult surgery patients in an autologous predonation programme.
għal 4 ġimgħat
Retacrit should be given by the intravenous route.
Aġġustament fid- doża F’ rata ta ’ żieda fl- emoglobina ta ’ > 2 g/ dl (> 1. 25 mmol/ l) fix- xahar id- doża ta ’ ’ Retacrit għanda tonqos b’ xi 25- 50%.
Mildly anaemic patients (haematocrit of 33-39%) requiring predeposit of ≥ 4 units of blood should be treated with Retacrit at a dose of 600 IU/ kg body weight 2 times weekly for 3 weeks prior to surgery.
Pazjenti b’ anemija ħafifa (ematokrit ta ’ 33- 39%) li għandhom bzonn depozitu minn qabel ta ’ ≥ 4 unità 20 ta ’ demm għandhom jiġu ttratati b’ Retacrit b’ doża ta ’ 600 IU/ kg tal- piż tal- ġisem darbtejn fil ġimgħa għal 3 ġimgħat qabel il- kirurġija.
All patients being treated with Retacrit should receive adequate iron supplementation (e. g.
Il- pazjenti kollha li qegħdin jiġu ttratati b’ Retacrit għandhom jirċievu supplementazzjoni tal- ħadid biżżejjed (eż.
18 Method of administration
Mod ta ’ kif jingħata
There may be a moderate dose-dependent rise in the platelet count within the normal range during treatment with erythropoietin.
21 Jista ’ ikun hemm żieda moderata, li tiddependi mid- doża, fl- għadd tal- plejtlits fil- limiti normali matul it- trattament bl- eritropojetin.
All other causes of anaemia (iron deficiency, haemolysis, blood loss, vitamin B12- or folate deficiencies) should be considered and treated prior to initiating and during therapy with Retacrit.
Il- kawżi l- oħra kollha ta ’ anemija (defiċjenza fil- ħadid, emolisi, telf ta ’ demm, vitamina B12 - jew defiċjenzi fil- folates) għandhom jiġu kkunsidrati u ttratati qabel il- bidu u waqt it- terapija b’ Retacrit.
200-300 mg/ day orally (100-200 mg/ day for paediatric patients) is recommended for chronic renal failure patients whose serum ferritin levels are below 100 ng/ ml − oral iron substitution of 200-300 mg/ day is recommended for all cancer patients whose
200- 300 mg/ jum b’ mod orali (100- 200 mg/ jum għall- pazjenti pedjatriċi) huwa rrakomandat għall- pazjenti li għandhom insuffiċjenza renali kronika li l- livelli tas- serum ferritin tagħhom huma taħt il- 100 ng/ ml − sostituzzjoni ta- ħadid orali ta ’ 200- 300 mg/ jum huwa rrakomandat għall- pazjenti kollha bil - kanċer li s- saturazzjoni tat- transferrin tagħhom huwa taħt l- 20%
The rate of increase in haemoglobin should be approximately 1 g/ dl (0.62 mmol/ l) per month and should not exceed 2 g/ dl (1.25 mmol/ l) per month to minimize the risk of developing or worsening of hypertension.
F’ pazjenti b ’ insuffiċjenza renali kronika u mard tal- qalb iskemiku li huwa klinikament evidenti jew, insuffiċjenza kongestiva fil- qalb, il- konċentrazzjoni tal- emoglobina tal- manteniment m’ għandhiex taqbeż il- limitu ta ’ fuq tal- konċentrazzjoni immirata tal- emoglobina kif irrakkomandata taħt sezzjoni 4. 2.
If no cause is identified, a bone marrow examination should be considered for diagnosis of PRCA.
Jekk l- ebda kawża ma tiġi identifikata, għandha tiġi kkunsidrata eżaminazzjoni tal- mudullun għad- dijanjosi tal- PRCA.
If PRCA is diagnosed, therapy with Retacrit must be immediately discontinued and testing for erythropoietin antibodies should be considered.
Jekk il- PRCA huwa ddijanjostikat, it- terapija b’ Retacrit trid titwaqqaf immedjatament u ttestjar għall - antikorpi tal- eritropojetin għandu jiġi kkunsidrat.
Patients should not be switched to another medicinal product as anti-erythropoietin antibodies cross-react with other erythropoietins.
Il- pazjenti m’ għandhomx jinbidlu għal fuq prodott ieħor peress li l- antikorpi anti- eritropojetini jirrejaġixxu ma ’ eritroptejini oħra.
Other causes of PRCA should be excluded, and appropriate therapy initiated.
Kawżi oħra ta ’ Pure 22 Red Cell Aplasia għandhom jiġu esklużi, u għandha tingħata terapija kif suppost.
Dialysis prescriptions may
F’ pazjenti b’ insuffiċjenza renali kronika, korrezzjoni għall- anemija tista ’ twassal għal żieda fl- aptit, u t- teħidtal- potassju u l- proteini.
20 have to be adjusted periodically to maintain urea, creatinine and potassium in the desired range.
Il- preskrizzjonijiet tad - dijalisi jistgħu jkollhom jiġu mibdula perjodikament sabiex l- ureja, il- krejatinina u l- potassju jinżammu fil- livell mixtieq.
Several controlled clinical studies in which epoetins were administered to patients with a variety of common tumours including squamous head and neck cancer, lung cancer, and breast cancer, have shown an unexplained excess mortality.
Diversi studji kliniċi b’ kontrolli li saru li fihom l- epoetini ġew mogħtija lil pazjenti b’ diversi tipi ta ’ tumuri komuni li jinkludu kanser skwamuż tar- ras u l- għonq, kanser tal- pulmun, u l- kanser tas- sider urew mortalità eċċessiva mhux spjegabbli.
In controlled clinical studies, use of Epoetin alfa and other erythropoiesis-stimulating agents (ESAs) have shown: • shortened time to tumour progression in patients with advanced head and neck cancer receiving radiation therapy when administered to target a haemoglobin of greater than 14 g/ dl (8.7 mmol/ l), • shortened overall survival and increased deaths attributed to disease progression at 4 months in patients with metastatic breast cancer receiving chemotherapy when administered to target a haemoglobin of 12-14 g/ dl (7.5 -8.7 mmol/ l),
Fi studji kliniċi b’ kontrolli, l- użu ta ’ Epoetin alfa u sustanzi oħra li jistimulaw eritropojesi (ESAs)
21 increased risk of death when administered to target a haemoglobin of 12 g/ dl (7.5 mmol/ l) in patients with active malignant disease receiving neither chemotherapy nor radiation therapy.
23 urew: • żmien imqassar għal progressjoni tat- tumur fil- pazjenti b’ kanser tar- ras u ta ’ l- għonq avvanzat li qed jirċievu terapija ta ’ radjazzjoni meta jingħata biex jintaħaq livell ta ’ emoglobina ta ’ aktar minn 14 g/ dl (8, 7 mmol/ l). • tnaqqis fis- sopravivenza globali u żieda fl- imwiet attribwiti għal firxa tal- marda fi żmien 4 xhur f’ pazjenti b’ kanser metastatiku tas- sider li qed jirċievu kimoterapija meta jingħata biex jintlaħaq livell ta ’ emoglobina ta ’ 12- 14 g/ dl (7. 5 - 8. 7 mmol/ l), żieda fir- riskju ta ’ mewt meta jingħata sabiex jintlaħaq livell mixtieq ta ’ emoglobina ta ’ 12 g/ dl (7. 5 mmol/ l) f’ pazjenti b’ mard malinn attiv li la qed jirċievu kimoterapija u lanqas terapija ta ’ radjazzjoni.
Factors that should be considered in this assessment should include the type of tumour and its stage; the degree of anaemia; life- expectancy; the environment in which the patient is being treated; and patient preference (see section 5.1)
Fatturi li għandhom jiġu kkonsidrati f’ din l- istima għandhom jinkludu t- tip ta ’ tumur u l- istadju li jkun wasal fih; il- grad tal - anemija; kemm mistennija tgħix persuna; l- ambjent fejn il- pazjent qed jiġi trattat; u l- preferenza tal - pazjent (ara sezzjoni 5. 1)
"Flu-like" symptoms such as headaches, joint pains, feelings of weakness, dizziness, and tiredness may occur, especially at the start of treatment.
24 Jista ’ jkun hemm sintomi "bħal ta ’ l- influwenza" fosthom uġigħ ta ’ ras, uġigħ fil- ġogi, sensazzjonijiet ta ’ dgħjufija, sturdament, u għeja, speċjalment fil- bidu tal- kura.
22 Hypersensitivity reactions have been rarely reported with epoetin alfa including isolated cases of angioedema and anaphylactic reaction.
Reazzjonijiet ta ’ sensittività eċċessiva kienu rrappurtati f’ każijiet rari b’ epoetin alfa, inklużi każijiet iżolati ta ’ anġoedema u reazzjoni anafilattika.
The four
Il- parti magħmula mill - proteina tikkontribwixxi xi 58% tal- massa totali u tikkonsisti minn 165 aċidi aminiċi.
23 carbohydrate chains are attached via three N-glycosidic bonds and one O-glycosidic bond to the protein.
L- erba ’ ktajjen ta ’ karboidrati huma imqabbda permezz ta ’ tliet rabtiet ta ’ N- glycosidic u rabta waħda ta ’ O- glycosidic mal - proteina.