qanastek/EMEA-V3 huggingface dataset:
Alternatively, epoetin alfa can be administered at an initial dose of 450 IU/ kg subcutaneously once weekly.
Inkella, epoetin alfa jista ’ jingħata b’ doża inizjali ta ’ 450 IU/ kg minn taħt il- ġilda darba fil- ġimgħa.
If 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 a week or 450 IU/ kg once weekly.
Jekk l- emoglobina tkun għoliet b’ mill- anqas 1 g/ dl (0. 62 mmol/ l) jew l- għadd ta ’ retikuloċiti żdied għal ≥ 40, 000 ċellula/ µl fuq il- linja bażi wara 4 ġimgħat ta ’ kura, id- doża għandha tibqa ’ 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 tkun < 1 g/ dl (< 0. 62 mmol/ l) u l- għadd tar - retikuloċiti jkun żdied < 40, 000 ċellula/ µl fuq il- linja 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 ’ kura bi 300 IU/ kg 3 darbiet fil- ġimgħa, l- emoglobina tkun żdiedet għal ≥ 1 g/ dl (≥ 0. 62 mmol/ l) jew l- għadd ta ’ retikuloċiti jkun żdied għal ≥ 40, 000 ċellula/ µl id- doża għandha tibqa ’ 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 to epoetin alfa therapy is unlikely and treatment should be discontinued.
Madankollu, jekk l- emoglobina tkun żdiedet għal < 1 g/ dl (< 0. 62 mmol/ l) u l- għadd ta ’ retikuloċiti jkun żdied għal < 40, 000 ċellula/ µl fuq il- linja bażi, respons għat- terapija b’ epoetin alfa ma jkunx probabbli u l- kura għandha titwaqqaf.
The recommended dosing regimen is described in the following diagram:
5 Il- kors ta ’ dożaġġ rakkomandat huwa deskritt fid- dijagramma li ġejja:
5 150 IU/ kg 3x/ week or 450 IU/ kg once weekly
150 IU/ kg 3x/ ġimgħa jew 450 IU/ kg darba fil- ġimgħa
for 4 weeks
għal 4 ġimgħat
Reticulocyte count increase ≥ 40,000/ µl
Żieda fl- għadd ta ’ retikuloċiti ≥ 40, 000/ µl
Reticulocyte count increase < 40,000/ µl
Żieda fl- għadd ta ’ retikuloċiti < 40, 000/ µl
or Hb increase ≥ 1 g/ d
jew żieda fl- Hb ≥ 1 g/ d
and Hb increase < 1 g/ dl
u żieda fl- Hb < 1 g/ dl
12 g/ dl)
Hb intenzjonata (madwar 12 g/ dl)
300 IU/ kg 3x/ week for 4 weeks
300 IU/ kg 3x/ ġimgħa għal 4 ġimgħat
Reticulocyte count increase ≥ 40,000/ µl or Hb increase ≥ 1 g/ dl
Żieda fl- għadd ta ’ retikuloċiti ≥ 40, 000/ µl jew żieda fl- Hb ≥ 1 g/ dl
Reticulocyte count increase < 40,000/ µl and Hb increase < 1 g/ dl
Żieda fl- għadd ta ’ retikuloċiti < 40, 000/ µl u żieda fl- Hb < 1 g/ dl
Discontinue therapy
Waqqaf il- kura
Dosage adjustment to maintain haemoglobin concentration between 10 g/ dl - 12 g/ dl:
Aġġustament tad- dożaġġ biex iżżomm il- konċentrazzjoni ta ’ l- emoglobina bejn 10 g/ dl - 12 g/ dl:
If the haemoglobin is rising by more than 2 g/ dl (1.25 mmol/ l) per month, or if the haemoglobin exceeds 12 g/ dl (7.5 mmol/ l), the dose should be reduced by approximately 25 to 50%.
Jekk l- emoglobina tkun qed tiżdied b’ iktar minn 2 g/ dl (1. 25 mmol/ l) kull xahar, jew jekk il- livell ta ’ emoglobina jaqbeż 12 g/ dl (7. 5 mmol/ l), id- doża għandha titnaqqas b’ madwar 25 sa 50%.
If the haemoglobin exceeds 13 g/ dl (8.1 mmol/ l), discontinue therapy until it falls below 12 g/ dl (7.5 mmol/ l) and than reinstitute epoetin alfa therapy at a dose 25% below the previous dose.
Jekk l - emoglobina taqbeż 13 g/ dl (8. 1 mmol/ l), waqqaf it- terapija sakemm il- livell jinżel taħt 12 g/ dl (7. 5 mmol/ l), u mbagħad erġa ’ ibda t- terapija b’ epoetin alfa b’ doża li tkun 25% taħt il- livell ta ’ qabel.
Adult surgery patients in an autologous predonation programme:
Pazjenti kirurġiċi adulti fi programm ta ’ predonazzjoni awtologa:
Binocrit should be given by the intravenous route.
Binocrit għandu jingħata ġol- vini.
At the time of donating blood, Binocrit should be administered after the completion of the blood donation procedure.
Meta jingħata d- demm, Binocrit għandu jingħata wara li titlesta l- proċedura tal- għoti tad- demm.
Mildly anaemic patients (haematocrit of 33 - 39%) requiring predeposit of ≥ 4 units of blood should be treated with Binocrit at a dose of 600 IU/ kg body weight 2 times weekly for 3 weeks prior to surgery.
Pazjenti li għandhom anemija ħafifa (ematokrit ta ’ 33 - 39%) li jeħtieġu predepożitu ta ’ ≥ 4 unitajiet ta ’ demm, għandhom jiġu kkurati b’ Binocrit b’ doża ta ’ 600 IU għal kull kilogramm ta ’ piż tal- ġisem darbtejn fil- ġimgħa għal 3 ġimgħat qabel l- operazzjoni.
All patients being treated with Binocrit should receive adequate iron supplementation (e. g.
Il- pazjenti kollha li jkunu qed jiġu kkurati b’ Binocrit għandhom jirċievu supplimentazzjoni adegwata tal- ħadid (eż.
200 mg oral elemental iron daily) throughout the course of treatment.
200 mg ta ’ ħadid elementali orali kuljum) matul il- kors tal- kura.
Iron supplementation should be started as soon as possible, even several weeks prior to initiating the autologous predeposit, in order to achieve high iron stores prior to starting Binocrit therapy.
Is- supplimentazzjoni tal- ħadid għandha tinbeda kemm jista ’ jkun malajr, anki diversi ġimgħat qabel ma jibda l- predepożitu awtologu, sabiex ikun hemm ħażna kbira ta ’ ħadid qabel ma tibda t- terapija b’ Binocrit.
Treatment of adult patients scheduled for major elective orthopaedic surgery:
6 Kura ta ’ pazjenti adulti skedati għal operazzjoni ortopedika elettiva maġġuri:
The subcutaneous route of administration should be used.
L- injezzjoni għandha tingħata minn taħt il- ġilda.
6 The recommended dose is 600 IU/ kg epoetin alfa, given weekly for three weeks (days 21, 14 and 7) prior to surgery and on the day of surgery (day 0).
Id- doża rakkomandata hi 600 IU/ kg epoetin alfa, mogħtija kull ġimgħa għal tliet ġimgħat (jum 21, 14 u 7) qabel l- operazzjoni u fil- jum ta ’ l- operazzjoni (jum 0).
In cases where there is a medical need to shorten the lead time before surgery to less than three weeks, 300 IU/ kg epoetin alfa should be given daily for 10 consecutive days prior to surgery, on the day of surgery and for four days immediately thereafter.
F’ każijiet fejn ikun hemm ħtieġa medika biex iż- żmien ta ’ tħejjija qabel l- operazzjoni jitqassar għal anqas minn tliet ġimgħat, għandhom jingħataw 300 IU/ kg epoetin alfa kuljum għal 10 ijiem konsekuttivi qabel l- operazzjoni, fil - jum ta ’ l- operazzjoni u għal erbat ijiem immedjatament wara.
When performing haematologic assessments during the preoperative period, if the haemoglobin level reaches 15 g/ dl, or higher, administration of epoetin alfa should be stopped and further doses should not be given.
Meta jitwettqu evalwazzjonijiet ematoloġiċi fil- perijodu ta ’ qabel l- operazzjoni, jekk il- livell ta ’ l- emoglobina jilħaq il- 15 g/ dl, jew ogħla, l- għoti ta ’ epoetin alfa għandu jitwaqqaf u ma jingħatawx aktar dożi.
Care should be taken to ensure that at the outset of the treatment patients are not iron deficient.
Trid tingħata attenzjoni biex jiġi żgurat li fil- bidu tal- kura, il- pazjenti ma jkunux neqsin mill- ħadid.
All patients being treated with epoetin alfa should receive adequate iron supplementation (e. g. oral iron substitution of 200 mg Fe2+ daily) throughout the course of epoetin alfa treatment.
Il- pazjenti kollha li jkunu qed jiġu kkurati b’ epoetin alfa għandhom jingħataw suppliment adegwat ta ’ ħadid (eż. sostituzzjoni orali ta ’ ferritin ta ’ 200 mg Fe2+ kuljum) matul il- kors tal- kura b’ epoetin alfa.
Iron supplementation should be started prior to epoetin alfa therapy, to achieve adequate iron stores.
Is- suppliment ta ’ ferritin għandu jinbeda qabel it- terapija b’ epoetin alfa, sabiex jinkisbu ħażniet adegwati ta ’ ħadid.
Method of administration
Mod ta ’ kif jingħata
Binocrit is a sterile but unpreserved product and is for single use only.
Binocrit huwa prodott sterili iżda mhux ippreservat u jintuża darba biss.
Administer the amount required.
Agħti l- ammont meħtieġ.
This medicinal product must not be administered by intravenous infusion, or mixed with other medicinal products.
Dan il- prodott mediċinali m’ għandux jingħata b’ infużjoni fil- vini, jew jitħallat ma ’ prodotti mediċinali oħra.
Intravenous injection: over at least one to five minutes, depending on the total dose.
Injezzjoni fil- vini: fuq perijodu ta ’ mill- anqas minuta sa ħames minuti, jiddependi fuq id- doża totali.
In haemodialysed patients, a bolus injection may be given during the dialysis session through a suitable venous port in the dialysis line.
F’ pazjenti fuq l- emodijalisi, injezzjoni bolus tista ’ tingħata matul is- sessjoni tad- dijalisi minn ġo toqba adegwata fil- vina fil- linja tad- dijalisi.
Alternatively, the injection can be given at the end of the dialysis session via the fistula needle tubing, followed by 10 ml of isotonic saline to rinse the tubing and ensure satisfactory injection of the product into the circulation.
Inkella, l- injezzjoni tista ’ tingħata fit - tmiem tas- sessjoni tad- dijalisi minn ġot- tubu tal- labra tal- fistla, segwita b’ 10 ml ta ’ soluzzjoni ta ’ saline isotoniku biex jitlaħlaħ it- tubu u tiġi żgurata injezzjoni sodisfaċenti tal- prodott fiċ - ċirkolazzjoni.
A slower injection is preferable in patients who react to the treatment with “ flu-like” symptoms.
Injezzjoni aktar bil- mod hija preferibbli f’ pazjenti li jirreaġixxu għall- kura b’ sintomi “ bħal ta ’ l - influwenza ”.
Subcutaneous injection: a maximum volume of 1 ml at one injection site should generally not be exceeded.
Injezzjoni taħt il- ġilda: ġeneralment m’ għandux jinqabeż volum massimu ta ’ 1 ml f’ post wieħed ta ’ l- injezzjoni.
In case of larger volumes, more than one site should be chosen for the injection.
Fil- każ ta ’ volumi akbar, għandu jintgħażel aktar minn post wieħed għall - injezzjoni.
The injections are given in the thighs or the anterior abdominal wall.
L- injezzjonijiet jingħataw fil- kuxxtejn u fil- ħajt addominali ta ’ quddiem.
In chronic renal failure patients Binocrit has not to be administered subcutaneously!
F’ pazjenti b’ insuffiċjenza renali kronika, Binocrit m’ għandux jingħata taħt il- ġilda!
The intravenous route has to be used (please see section 4.4 - chronic renal failure patients).
Għandu jintuża l- għoti minn ġol- vini (jekk jogħġbok ara sezzjoni 4. 4 - pazjenti b’ insuffiċjenza renali kronika).
4.3 Contraindications
4. 3 Kontra- indikazzjonijiet
Hypersensitivity to the active substance or to any of the excipients.
Sensittività eċċessiva għas- sustanza attiva jew għal xi sustanzi mhux attivi.
Patients who develop Pure Red Cell Aplasia (PRCA) following treatment with any erythropoietin should not receive Binocrit or any other erythropoietin (see section 4.4 - Pure Red Cell Aplasia).
Pazjenti li jiżviluppaw Aplasja taċ- Ċelluli l- Ħomor tad- Demm Pura (PRCA) wara kura b’ xi eritropoetin, m’ għandhomx jingħataw Binocrit jew xi eritropoetin ieħor (ara sezzjoni 4. 4 – Aplasja taċ- Ċelluli l- Ħomor tad- Demm Pura).
Uncontrolled hypertension.
Pressjoni għolja mhux ikkontrollata.
In the indication “ increasing the yield of autologous blood”: myocardial infarction or stroke in the month preceding treatment, unstable angina pectoris, increased risk of deep venous thrombosis such as history of venous thromboembolic disease.
Fl- indikazzjoni “ biex iżid l- ammont ta ’ demm awtologu ”: infart mijokardijaku jew puplesija fix- xahar ta ’ qabel il- kura, anġina pectoris instabbli, żieda fir- riskju ta ’ trombożi venuża profonda, bħal storja medika ta ’ mard tromboemboliku venuż.
Patients who for any reason cannot receive adequate antithrombotic prophylaxis.
Pazjenti li għal xi raġuni ma jistgħux jirċievu profilassi antitrombotika adegwata.
The use of epoetin alfa in patients scheduled for major elective orthopaedic surgery and not participating in an autologous blood predonation programme is contraindicated in patients with severe coronary, peripheral arterial, carotid or cerebral vascular disease, including patients with recent myocardial infarction or cerebral vascular accident.
L- użu ta ’ epoetin alfa f’ pazjenti skedati għal operazzjoni ortopedika elettiva maġġuri u li ma jkunux qegħdin jipparteċipaw fi programm ta ’ predonazzjoni tad- demm awtologu, huwa kontra- indikat
4.4 Special warnings and precautions for use
4. 4 Twissijiet speċjali u prekawzjonijiet għall- użu
General
Ġenerali
In all patients receiving epoetin alfa, blood pressure should be closely monitored and controlled as necessary.
Il- pressjoni tad- demm, fil- pazjenti kollha li jkunu qegħdin jirċievu epoetin alfa, għandha tiġi mmonitorjata mill- qrib u kkontrollata kif meħtieġ.
Epoetin alfa should be used with caution in the presence of untreated, inadequately treated
Epoetin alfa għandu jintuża b’ attenzjoni fil - preżenza ta ’ pressjoni għolja mhux ikkurata, ikkurata b’ mod inadegwat jew li ma tantx tista ’ tiġi kkontrollata sewwa.
It may be necessary to add or increase antihypertensive treatment.
Jista ’ jkun hemm bżonn li żżid jew tqawwi l- kura kontra l- pressjoni għolja.
If blood pressure cannot be controlled, epoetin alfa treatment should be discontinued.
Jekk il- pressjoni tad- demm ma tkunx tista ’ tiġi kkontrollata, il- kura b’ epoetin alfa għandha titwaqqaf.
Epoetin alfa should be used with caution in the presence of epilepsy and chronic liver failure.
Epoetin alfa għandu jintuża b’ attenzjoni fil- preżenza ta ’ epilessija u insuffiċjenza tal- fwied kronika.
There may be a moderate dose-dependent rise in the platelet count within the normal range during treatment with epoetin alfa.
Jista ’ jkun hemm żieda moderata dipendenti fuq id- doża fl- għadd ta ’ plejtlits fil- medda tan- normalità waqt kura b’ epoetin alfa.
This regresses during the course of continued therapy.
Din titreġġa ’ lura fil- kors ta ’ terapija kontinwa.
It is recommended that the platelet count is regularly monitored during the first 8 weeks of therapy.
Huwa rakkomandat li l - għadd tal- plejtlits jiġi mmonitorjat b’ mod regolari matul l- ewwel 8 ġimgħat tat- terapija.
All other causes of anaemia (iron deficiency, haemolysis, blood loss, vitamin B12 or folate deficiencies) should be considered and treated prior to initiating therapy with epoetin alfa.
Il- kawżi l- oħra kollha ta ’ anemija (defiċjenza ta ’ ħadid, l- emodijalisi, telf ta ’ demm, defiċjenza ta ’ vitamina B12 jew ta ’ folate) għandhom jiġu kkunsidrati u kkurati qabel ma tinbeda t- terapija b’ epoetin alfa.
In most cases, the ferritin values in the serum fall simultaneously with the rise in packed cell volume.
Fil- maġġoranza tal- każijiet, il- figuri tal- livell ta ’ ferritin fis- serum jonqsu simultanjament maż - żieda fil- volum taċ- ċelluli ppakkjati.
In order to ensure optimum response to epoetin alfa, adequate iron stores should be assured:
Sabiex jiġi żgurat l- aħjar respons għal epoetin alfa, għandhom jiġu żgurati ħażniet adegwati ta ’ ħadid: suppliment ta ’ ħadid, eż.
200 - 300 mg Fe2+/ day orally (100 - 200 mg Fe2+/ day for paediatric
200 - 300 mg Fe2+/ jum b’ mod orali (100 - 200 mg Fe2+/ jum għal
patients) is recommended for chronic renal failure patients whose serum ferritin levels are below 100 ng/ ml
pazjenti pedjatriċi) huwa rakkomandat għal pazjenti b’ insuffiċjenza tal- kliewi kronika li l- livelli ta ’ ferritin fis- serum tagħhom huma taħt il- 100 ng/ ml sostituzzjoni orali tal- livell ta ’ ferritin ta ’ 200 - 300 mg Fe2+/ jum huwa rakkomandat għal
transferrin saturation is below 20%.
pazjenti morda bil- kanċer li s- saturazzjoni tal- ferritin tagħhom hija taħt l- 20%.
All of these additive factors of anaemia should also be carefully considered when deciding to increase the dose of epoetin alfa in cancer patients.
Dawn il- fatturi addizzjonali kollha ta ’ l- anemija għandhom jiġu kkunsidrati bir- reqqa meta jiġi deċiż li tiżdied id- doża ta ’ epoetin alfa f’ pazjenti morda bil- kanċer.
Good blood management practices should always be used in the perisurgical setting
Prattiċi tajba ta ’ mmaniġġar tad- demm għandhom dejjem jintużaw fi sfond perikirurġiku
Pure Red Cell Aplasia (PRCA) Antibody-mediated PRCA has been very rarely reported after months to years of subcutaneous erythropoietin treatment.
Aplasja taċ- Ċelluli l- Ħomor tad- Demm Pura (PRCA) PRCA medjata mill- antikorpi ġiet irrappurtata b’ mod rari ħafna wara perijodu ta ’ minn xhur sa snin ta ’ kura b’ eritropoetin mgħoti minn taħt il- ġilda.
In patients developing sudden lack of efficacy defined by a decrease in haemoglobin (1 to 2 g/ dl per month) with increased need for transfusions, a reticulocyte count should be obtained and typical causes of non-response (e. g. iron, folate or, vitamin B12 deficiency, aluminium intoxication, infection or inflammation, blood loss and haemolysis) should be investigated.
F’ pazjenti li jiżviluppaw nuqqas f’ daqqa ta ’ effikaċja definit bi tnaqqis fl- emoglobina (1 sa 2 g/ dl fix- xahar) bi ħtieġa akbar ta ’ trasfużjonijiet, għandu jinkiseb għadd tar- retikuloċiti u jiġu investigati l- kawżi tipiċi tan- nuqqas ta ’ respons (eż. defiċjenza ta ’ ħadid, folate, jew vitamina BB12, avvelenament ta ’ l- aluminju, infezzjoni jew infjammazzjoni, telf ta ’ demm u l- emodijalisi).
If the reticulocyte count corrected for anaemia (i. e., the reticulocyte “ index”) is low (< 20,000/ mm3 or < 20,000/ microlitre or < 0.5%), platelet and white blood cell counts are normal, and if no other cause of loss of effect has been found, anti-erythropoietin antibodies should be determined and bone marrow examination should be considered for diagnosis of PRCA.
Jekk l- għadd ta ’ retikuloċiti aġġustat għall- anemija (i. e., l - “ indiċi ” tar- retikuloċiti) ikun baxx (< 20, 000/ mm3 jew < 20, 000/ mikrolitru jew < 0. 5%), l- għadd tal- plejtlits u taċ- ċelluli bojod tad- demm ikun normali, u jekk ma tinstab l- ebda kawża oħra ta ’ telf ta ’ l- effett, għandhom jiġu evalwati l - antikorpi kontra l- eritropoetin u jiġi kkunsidrat eżami tal- mudullun għal dijanjosi ta ’ PRCA.
If anti-erythropoietin, antibody-mediated PRCA is suspected, therapy with Binocrit should be discontinued immediately.
Jekk tkun issuspettata PRCA medjata b’ antikorpi kontra l- eritropoetin, it- terapija b’ Binocrit għandha titwaqqaf immedjatament.
No other erythropoietic therapy should be commenced because of the risk of cross-reaction.
M’ għandha tinbeda l- ebda terapija erythropoietic oħra minħabba r- riskju ta ’ cross- reaction.
Appropriate therapy such as blood transfusions may be given to patients when indicated.
Terapija xierqa bħal trasfużjonijiet tad- demm tista ’ tingħata lill- pazjenti meta indikat.
Chronic renal failure patients
Pazjenti b’ insuffiċjenza renali kronika
Immunogenicity data for subcutaneous use of Binocrit in patients at risk for antibody-induced PRCA, i. e. patients with renal anaemia, are not sufficient.
Informazzjoni dwar l- immunoġeniċità għall- użu minn taħt il- ġilda ta ’ Binocrit f’ pazjenti f’ riskju għal PRCA ikkawżata mill- antikorpi, i. e. pazjenti b’ anemija renali, mhix suffiċjenti.
Therefore, in patients with renal anaemia the medicinal product has to be administered intravenously.
Għalhekk, f’ pazjenti b’ anemija renali, il- prodott mediċinali għandu jingħata minn ġol- vini.
In patients with chronic renal failure, maintenance haemoglobin concentration should not exceed the upper limit of the target haemoglobin concentration recommended in section 4.2.
8 F’ pazjenti b’ insuffiċjenza renali kronika, il- konċentrazzjoni ta ’ l- emoglobina mantenuta m’ għandhiex taqbeż il- limitu ta ’ fuq tal- konċentrazzjoni ta ’ l- emoglobina mmirata rakkomandata f’ sezzjoni 4. 2.
In clinical trials, an increased risk of death and serious cardiovascular events was observed when erythropoiesis stimulating agents (ESAs) were administered to target a haemoglobin of greater than 12 g/ dl (7.5 mmol/ l).
Fi provi kliniċi, żieda fir- riskju ta ’ mewt u avvenimenti kardjovaskulari serji kienet osservata meta mediċini li jistimulaw l- eritropoeżi (ESAs) ingħataw biex jinkiseb livell ta ’ emoglobina ta ’ iktar minn 12 g/ dl (7. 5 mmol/ l).
Controlled clinical trials have not shown significant benefits attributable to the administration of epoetins when haemoglobin concentration is increased beyond the level necessary to control symptoms of anaemia and to avoid blood transfusion.
Provi kliniċi kkontrollati ma wrewx benefiċċji sinifikanti attribwibbli għall- għoti ta ’ epoetins meta l - konċentrazzjoni ta ’ l- emoglobina tiżdied aktar mil- livell meħtieġ biex tikkontrolla s- sintomi ta ’ l - anemija u biex tevita trasfużjoni tad- demm.
Haemoglobin levels should be measured on a regular basis until a stable level is achieved and periodically thereafter.
Il- livelli ta ’ l- emoglobina għandhom jitkejlu fuq bażi regolari sakemm jinkiseb livell stabbli u b’ mod perjodiku wara.
8 (0.62 mmol/ l) per month and should not exceed 2 g/ dl (1.25 mmol/ l) per month to minimise risks of an increase in hypertension.
Ir- rata taż- żieda fl- emoglobina għandha tkun madwar 1 g/ dl (0. 62 mmol/ l) fix- xahar u m’ għandhiex taqbeż iż- 2 g/ dl (1. 25 mmol/ l) fix- xahar sabiex jitnaqqsu r- riskji ta ’ żieda fil- pressjoni għolja.
Hyperkalaemia has been observed in isolated cases.
Iperkalimja ġiet osservata f’ każijiet iżolati.
Correction for anaemia may lead to increased appetite, and potassium and protein intake.
L- aġġustament għall- anemija jista ’ jwassal għal żieda fl - aptit, u fil- konsum ta ’ potassju u proteini.
Dialysis prescriptions may have to be adjusted periodically to maintain urea, creatinine and potassium in the desired range.
Il- preskrizzjonijiet tad- dijalisi jista ’ jkun hemm bżonn li jiġu aġġustati sabiex l- urea, il- krejatinina u l- potassju jinżammu fil- medda mixtieqa.
Serum electrolytes should be monitored in chronic renal failure patients.
L- elettroliti fis- serum għandhom jiġu mmonitorjati f’ pazjenti b’ insuffiċjenza renali kronika.
If an elevated (or rising) serum potassium level is detected then consideration should be given to ceasing epoetin alfa administration until hyperkalaemia has been corrected.
Jekk jinstab livell għoli (jew qed jogħla) ta ’ potassju fis- serum, f’ dak il- każ wieħed għandu jikkunsidra li jwaqqaf epoetin alfa sakemm l- iperkalimja tkun ġiet irranġata.
An increase in heparin dose during haemodialysis is frequently required during the course of therapy with epoetin alfa as a result of the increased packed cell volume.
Żieda fid- doża ta ’ heparin waqt l- emodijalisi sikwit tkun meħtieġa matul it- terapija b’ epoetin alfa minħabba l- volum akbar ta ’ ċelluli ppakkjati.
Occlusion of the dialysis system is possible if heparinisation is not optimum.
L- okklużjoni tas- sistema ta ’ dijalisi hija possibbli jekk l - eparinizzazzjoni ma tkunx ottima.
In patients with chronic renal failure and clinically evident ischaemic heart disease or congestive heart failure, maintenance haemoglobin concentration should not exceed the upper limit of the target haemoglobin concentration as recommended under section 4.2.
F’ pazjenti b’ insuffiċjenza renali kronika u mard tal- qalb iskemiku jew insuffiċjenza tal- qalb konġestiva klinikament evidenti, il- konċentrazzjoni ta ’ emoglobina fil- fażi ta ’ manteniment m’ għandhiex taqbeż il- limitu ta ’ fuq tal- konċentrazzjoni ta ’ l- emoglobina intenzjonata li tintlaħaq kif rakkomandat taħt sezzjoni 4. 2.
Based on information available to date, correction of anaemia with epoetin alfa in adult patients with renal insufficiency not yet undergoing dialysis does not accelerate the rate of progression of renal insufficiency.
Ibbażat fuq l- informazzjoni disponibbli sal- lum, il- korrezzjoni ta ’ l- anemija b’ epoetin alfa f’ pazjenti adulti b’ insuffiċjenza tal- kliewi li jkunu għadhom mhumiex fuq id - dijalisi, ma żżidx ir- rata tal - progressjoni ta ’ l- insuffiċjenza tal- kliewi.
Adult cancer patients with symptomatic anaemia receiving chemotherapy
Pazjenti adulti morda bil- kanċer b’ anemija sintomatika li jkunu qegħdin jirċievu l- kimoterapija
In cancer patients receiving chemotherapy, the 2 - 3 week delay between epoetin alfa administration and the appearance of erythropoietin-induced red cells should be taken into account when assessing if epoetin alfa therapy is appropriate (patient at risk of being transfused).
F’ pazjenti morda bil- kanċer li jkunu qegħdin jirċievu l- kimoterapija, it- 2 - 3 ġimgħat dewmien bejn l - għoti ta ’ epoetin alfa u d- dehra ta ’ ċelluli l- ħomor ikkaġunati bl- eritropoetin għandhom jiġu kkunsidrati meta jiġi evalwat jekk it- terapija b’ epoetin alfa tkunx adattata (pazjenti f’ riskju ta ’ trasfużjoni).
If the rate of increase in haemoglobin exceeds 2 g/ dl (1.25 mmol/ l) per month or the haemoglobin level exceeds 13 g/ dl (8.1 mmol/ l)m, the dose adaptation detailed in section 4.2 should be thoroughly performed to minimise the risk for thrombotic events (see section 4.2 Treatment of patients with chemotherapy induced anaemia - Dosage adjustment to maintain haemoglobin concentration between 10 g/ dl - 12 g/ dl).
Jekk ir- rata taż- żieda ta ’ l- emoglobina taqbeż iż- 2 g/ dl (1. 25 mmol/ l) fix- xahar jew il - livell ta ’ l- emoglobina jaqbeż it- 13 g/ dl (8. 1 mmol/ l) m, l- aġġustament fid- doża imfisser f’ sezzjoni 4. 2 għandu jitwettaq kompletament sabiex jitnaqqas ir- riskju għal episodji trombotiċi (ara sezzjoni 4. 2 Kura ta ’ pazjenti b’ anemija kkawżata mill- kimoterapija - Aġġustament tad- dożaġġ biex iżżomm il - konċentrazzjoni ta ’ l- emoglobina bejn 10 g/ dl - 12 g/ dl).
As an increased incidence of thrombotic vascular events (TVEs) has been observed in cancer patients receiving erythropoiesis-stimulating agents (see section 4.8), this risk should be carefully weighed against the benefit to be derived from treatment (with epoetin alfa) 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 vein thrombosis or pulmonary embolism).
Billi kienet osservata inċidenza akbar ta ’ episodji trombotiċi vaskulari (TVEs) f’ pazjenti morda bil - kanċer li kienu qed jirċievu sustanzi li jistimulaw l- eritropoeżi (ara sezzjoni 4. 8), dan ir- riskju għandu jiġi evalwat bir- reqqa kontra l- benefiċċju li jista ’ joħroġ mill- kura (b’ epoetin alfa) b’ mod partikulari f’ pazjenti morda bil- kanċer li jkunu f’ riskju akbar ta ’ episodji trombotiċi vaskulari, bħall- obeżità u pazjenti b’ passat mediku preċedenti ta ’ TVEs (eż. trombożi tal- vini profonda jew emboliżmu pulmonari).
An investigational study (BEST study) in women with metastatic breast cancer was designed to determine whether epoetin alfa treatment that extended beyond the correction of anaemia could improve treatment outcomes.
Studju investigattiv (l- istudju BEST) f' nisa b' kanċer metastatiku tas- sider, kien iddisinjat biex jistabbilixxi jekk il- kura b' epoetin alfa li kienet aktar minn dik meħtieġa għall- korrezzjoni ta 'l - anemija, tistax ittejjeb ir- riżultati tal- kura.
In that study the incidence of fatal thromboembolic events was higher in patients receiving epoetin alfa than in those receiving placebo (see section 5.1).
9 fatali kienet ogħla f’ pazjenti li kienu qed jirċievu epoetin alfa milli f’ dawk li kienu qed jirċievu l - plaċebo (ara sezzjoni 5. 1).
In view of the above, in some clinical situations blood transfusions should be the preferred treatment for the management of anaemia in patients with cancer.
Minħabba dan t’ hawn fuq, f’ xi sitwazzjonijiet kliniċi, it- trasfużjonijiet tad- demm għandhom ikunu l - kura preferuta għall- immaniġġjar ta ’ l- anemija f’ pazjenti morda bil- kanċer.
The decision to administer recombinant erythropoietins should be based on a benefit-risk assessment with the participation of the individual patient, which should also take into account the specific clinical context.
Id- deċiżjoni li jingħataw erythropoietins rikombinanti għandha tkun ibbażata fuq evalwazzjoni dwar il- benefiċċju- riskju bil - parteċipazzjoni tal- pazjent individwali, li għandha wkoll tikkunsidra l- 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 kkunsidrati f’ din l- evalwazzjoni għandhom jinkludu t- tip ta ’ tumur u l- fażi tiegħu; il- grad ta ’ anemija; kemm il- persuna hi mistennija li tgħix; l- ambjent li fih il- pazjent ikun qed jiġi kkurat; u l- preferenza tal- pazjent (ara sezzjoni 5. 1).
Adult surgery patients in an autologous predonation programme
Pazjenti kirurġiċi adulti fi programm ta ’ predonazzjoni awtologa
All special warnings and precautions associated with autologous predonation programmes, especially routine volume replacement, should be respected.
It- twissijiet u l- prekawzjonijiet speċjali kollha marbuta ma ’ programmi ta ’ predonazzjoni awtologa, speċjalment is- sostituzzjoni tal- volum ta ’ rutina, għandhom jiġu rrispettati.
9 Patients scheduled for major elective orthopaedic surgery
Pazjenti skedati għal operazzjoni ortopedika elettiva maġġuri
In patients scheduled for major elective orthopaedic surgery the cause of anaemia should be established and treated, if possible, before the start of epoetin alfa treatment.
F’ pazjenti skedati għal operazzjoni ortopedika elettiva maġġuri, il- kawża ta ’ l- anemija għandha tiġi stabbilita u kkurata, jekk jista ’ jkun, qabel ma tinbeda l- kura b’ epoetin alfa.
Thrombotic events can be a risk in this population and this possibility should be carefully weighed against the benefit to be derived from the treatment in this patient group.
L- episodji trombotiċi jistgħu jkunu riskju f’ din il- popolazzjoni u din il- possibbiltà għandha tiġi evalwata bir- reqqa kontra l - benefiċċju li jista ’ jinkiseb mill- kura f’ dan il- grupp ta ’ pazjenti.
Patients scheduled for major elective orthopaedic surgery should receive adequate antithrombotic prophylaxis, as thrombotic and vascular events may occur in surgical patients, especially in those with underlying cardiovascular disease.
Il- pazjenti skedati għal operazzjoni ortopedika elettiva maġġuri għandhom jirċievu profilassi antitrombotika adegwata, billi episodji trombotiċi u vaskulari jistgħu jseħħu f’ pazjenti ta ’ l - operazzjoni, speċjalment f’ dawk li jkollhom mard kardjovaskulari primarju.
In addition, special precaution should be taken in patients with predisposition for development of deep vein thrombosis (DVTs).
Barra minn hekk, għandhom jittieħdu prekawzjonijiet speċjali f’ pazjenti li jkunu predisposti għall- iżvilupp ta ’ trombożi fil- vini fonda (DVTs).
Moreover, in patients with a baseline haemoglobin of > 13 g/ dl, the possibility that epoetin alfa treatment may be associated with an increased risk of postoperative thrombotic/ vascular events cannot be excluded.
Barra dan, f’ pazjenti b’ emoglobina fil- linja bażi ta ’ > 13 g/ dl, il- possibbiltà li l - kura b’ epoetin alfa tista ’ tkun assoċjata ma ’ riskju akbar ta ’ episodji trombotiċi/ vaskulari wara l - operazzjoni ma tistax tiġi eskluża.
Therefore, it should not be used in patients with baseline haemoglobin > 13 g/ dl.
Għalhekk, m’ għandux jintuża f’ pazjenti li jkollhom emoglobina fil - linja bażi ta ’ > 13 g/ dl.
Tumour growth potential
Potenzjal ta ’ tkabbir ta ’ tumuri
Erythropoietins are growth factors that primarily stimulate red blood cell production.
L- eritropoetins huma fatturi tat- tkabbir li jistimulaw primarjament il- produzzjoni taċ- ċelluli l- ħomor tad- demm.
Erythropoietin receptors may be expressed on the surface of a variety of tumour cells.
Ir- riċetturi ta ’ l- eritropoetins jistgħu jkunu espressi fuq il- wiċċ ta ’ diversi ċelluli tat- tumuri.
As with all growth factors, there is a concern that epoetins could stimulate the growth of tumours.
Bħal kull fattur ieħor tat- tkabbir, hemm it- tħassib li l- epoetins jistgħu jistimulaw it- tkabbir tat- tumuri.
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 kkontrollati, ma ntweriex li l- epoetins itejbu s- sopravivenza totali jew li jnaqqsu r - riskju ta ’ progressjoni tat- tumur f’ pazjenti b’ anemija assoċjata ma ’ kanċer.
In controlled clinical studies, use of Epoetin alfa and other erythropoiesis-stimulating agents (ESAs) have shown:
Fi studji kliniċi kkontrollati, l- użu ta ’ Epoetin alfa u mediċini oħrajn li jistimulaw l- eritropoeżi (ESAs) urew:
- decreased locoregional control in patients with advanced head and neck cancer receiving
- tnaqqis fil- kontroll lokoreġjonali f’ pazjenti b’ kanċer avvanzat tar- ras u ta ’ l- għonq li jkunu qed
radiation therapy when administered to target a haemoglobin of greater than 14 g/ dl (8.7 mmol/ l),
jirċievu terapija bir- radjazzjoni meta jingħata biex ikun immirat livell ta ’ emoglobina ta ’ iktar minn 14 g/ dl (8. 7 mmol/ l),
- shortened overall survival and increased deaths attributed to disease progression at 4 months in
- sopravivenza totali mqassra u żieda fl- imwiet attribwiti għall- progressjoni tal- marda wara
patients with metastatic breast cancer receiving chemotherapy when administered to target a haemoglobin of 12 - 14 g/ dl (7.5 – 8.7 mmol/ l),
4 xhur f’ pazjenti b’ kanċer metastatiku tas- sider li jkunu qed jirċievu kimoterapija meta jingħata biex ikun immirat livell ta ’ emoglobina ta ’ 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
- żieda fir- riskju ta ’ mewt meta jingħata biex ikun ikun immirat livell ta ’ emoglobina ta ’ 12 g/ dl
patients with active malignant disease receiving neither chemotherapy nor radiation therapy.
(7. 5 mmol/ l) f’ pazjenti b’ mard malinn attiv li ma jkunux qed jirċievu la kimoterapija u lanqas terapija bir- radjazzjoni.
ESAs are not indicated for use in this patient population.
L- ESAs mhumiex indikati għall- użu f’ din il- popolazzjoni ta ’ pazjenti.
Excipients
Sustanzi mhux attivi
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i. e. essentially “ sodium- free”.
Dan il- prodott mediċinali fih anqas minn 1 mmol sodium (23 mg) f’ kull doża, jiġifieri essenzjalment “ ħieles mis- sodium ”
4.5 Interaction with other medicinal products and other forms of interaction
10 4. 5 Prodotti mediċinali oħra li ma jaqblux ma ’ dan il- prodott u affarijiet oħra li jistgħu jibdlu l- effett farmaċewtiku tal- prodott
No evidence exists that indicates that treatment with epoetin alfa alters the metabolism of other medicinal products.
Ma teżistix evidenza li tindika li l- kura b’ epoetin alfa tbiddel il- metaboliżmu ta ’ prodotti mediċinali oħra.
However, since cyclosporin is bound by red blood cells there is potential for an interaction.
Madankollu, billi cyclosporin jeħel maċ- ċelluli l- ħomor tad- demm, hemm il- potenzjal għal interazzjoni.
If epoetin alfa is given concomitantly with cyclosporin, blood levels of cyclosporin should be monitored and the dose of cyclosporin adjusted as the haematocrit rises.
Jekk epoetin alfa jingħata fl- istess waqt ma ’ cyclosporin, il- livelli ta ’ cyclosporin fid - demm għandhom jiġu mmonitorjati u d- doża ta ’ cyclosporin aġġustata hekk kif jogħla l- ematokrit.
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 tad - differenzjar ematoloġiku jew il- proliferazzjoni ta ’ kampjuni ta ’ bijopsiji tat- tumuri in vitro.
4.6 Pregnancy and lactation
4. 6 Tqala u treddigħ
There are no adequate and well-controlled studies in pregnant women.
M’ hemmx tagħrif biżżejjed u kkontrollat sewwa dwar l- użu ta ’ Epoetin waqt it- tqala.
Studies in animals have shown reproduction toxicity (see section 5.3).
Studji fuq il - bhejjem urew tossiċità fuq is- sistema riproduttiva (ara 5. 3).
Consequently:
Għalhekk:
- In chronic renal failure patients, epoetin alfa should be used in pregnancy only if the potential
- F’ pazjenti b’ insuffiċjenza renali kronika, epoetin alfa għandu jintuża waqt it- tqala biss jekk il -
benefit outweighs the potential risk to the foetus.
vantaġġ potenzjali jisboq ir- riskju potenzjali għall- fetu.
- In pregnant or lactating surgical patients participating in an autologous blood predonation
- F’ pazjenti li jkunu tqal jew qed ireddgħu li jkunu qed jipparteċipaw fi programm ta ’
programme, the use of epoetin alfa is not recommended.
predonazzjoni awtologa tad- demm, l- użu ta ’ epoetin alfa mhuwiex rakkomandat.
4.7 Effects on ability to drive and use machines
4. 7 Effetti fuq il- ħila biex issuq u tħaddem magni
Binocrit has no influence on the ability to drive and use machines.
Binocrit m’ għandu l- ebda effett fuq il- ħila ta ’ sewqan u l- użu ta ’ magni.
4.8 Undesirable effects
4. 8 Effetti mhux mixtieqa
The most frequent adverse reaction is an increase in blood pressure or aggravation of existing hypertension.
L- aktar reazzjoni avversa frekwenti hija żieda fil- pressjoni tad- demm jew aggravar ta ’ pressjoni għolja eżistenti.
Hypertensive crisis with encephalopathy-like symptoms can occur.
Jista ’ jkun hemm kriżi ta ’ pressjoni għolja b’ sintomi bħal ta ’ enċefalopatija.
Attention should be paid to sudden stabbing migraine-like headaches as a possible warning signal.
Għandha tingħata attenzjoni għal uġigħ ta ’ ras qawwi f’ daqqa li jixbah lill- emigranja, bħala sinjal possibbli ta ’ twissija.
Non-specific skin rashes have been described in association with epoetin alfa.
Raxxijiet tal- ġilda mhux speċifiċi ġew deskritti b’ rabta ma ’ epoetin alfa.
"Flu-like" symptoms such as headaches, joint pains, feelings of weakness, dizziness, and tiredness may occur, especially at the start of treatment.
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.
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, including patients receiving epoetin alfa.
Episodji trombotiċi/ vaskulari, bħal iskemja 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 eritropoetiċi, fosthom pazjenti li kienu qed jirċievu epoetin alfa.
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 ’ anġo- edema u reazzjoni anafilattika.
Antibody-mediated erythroblastopenia (PRCA) has been reported after months to years of treatment with epoetin alfa.
Eritroblastopenja medjata mill- antikorpi (PRCA) ġiet irrappurtata wara perijodu ta ’ minn xhur sa snin ta ’ kura b’ epoetin alfa.
In most of these patients, antibodies to erythropoietins have been observed (see sections 4.3 and 4.4 – Pure Red Cell Aplasia)
Fil- maġġoranza ta ’ dawn il- pazjenti, kienu osservati antikorpi għall - eritropoetins (ara sezzjoni 4. 3 u 4. 4 – Aplasja taċ- Ċelluli l- Ħomor tad- Demm Pura)
Adult and paediatric haemodialysis patients, adult peritoneal dialysis patients and adult patients with renal insufficiency not yet undergoing dialysis
11 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
The most frequent adverse reaction during treatment with epoetin alfa is a dose-dependent increase in blood pressure or aggravation of existing hypertension.
L- aktar reazzjoni avversa frekwenti waqt kura b’ epoetin alfa hija żieda dipendenti fuq id- doża fil - pressjoni tad- demm jew aggravar ta ’ pressjoni għolja eżistenti.
These increases in blood pressure can be treated with medicinal products.
Dawn iż- żidiet fil- pressjoni tad- demm jistgħu jiġu kkurati bi prodotti mediċinali.
Moreover, monitoring of the blood pressure is recommended particularly at the start of therapy.
Barra minn hekk, huwa rakkomandat monitoraġġ tal - pressjoni tad- demm, b’ mod partikulari fil- bidu tat- terapija.
The following reactions have also occurred in isolated patients with normal or low blood pressure: hypertensive crisis with encephalopathy-like symptoms (e. g. headaches and confused state) and generalised tonoclonal seizures, requiring the immediate attention of a physician and intensive medical care.
Ir- reazzjonijiet li ġejjin seħħew ukoll f’ pazjenti iżolati bi pressjoni tad- demm normali jew baxxa: kriżi ta ’ pressjoni għolja b’ sintomi bħal ta ’ l- enċefalopatija (eż. uġigħ ta ’ ras u stat konfuż) u aċċessjonijiet tonokloniċi ġeneralizzati, li kienu jeħtieġu l- attenzjoni immedjata ta ’ tabib u kura medika intensiva.
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.
Shunt thromboses may occur, especially in patients who have a tendency to hypotension or whose arteriovenous fistulae exhibit complications (e. g. stenoses, aneurysms, etc.).
Jistgħu jseħħu trombożi fix- xant, speċjalment f’ pazjenti li jkollhom tendenza għal pressjoni baxxa jew li l- fistuli bejn l- arterji u l- vini tagħhom juru komplikazzjonijiet (eż. stenosijiet, anewriżmi, eċċ.).
Early shunt revision and thrombosis prophylaxis by administration of acetylsalicylic acid, for example, is recommended in these patients.
Reviżjoni bikrija tax- xant u profilassi tat- trombożi bl- għoti ta ’ acetylsalicylic acid, per eżempju, huwa rakkomandat f’ dawn il- pazjenti.
Adult cancer patients with symptomatic anaemia receiving chemotherapy
Pazjenti adulti morda bil- kanċer b’ anemija sintomatika li jkunu qegħdin jirċievu kimoterapija
Hypertension may occur in epoetin alfa treated patients.
Jista ’ jkun hemm pressjoni għolja fil- pazjenti kkurati b’ epoetin alfa.
Consequently, haemoglobin and blood pressure should be closely monitored.
Għalhekk, l- emoglobina u l - pressjoni tad- demm għandhom jiġu mmonitorjati mill- viċin.
11 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 eritropoetiċi.
Surgery patients in autologous predonation programmes
Pazjenti kirurġiċi fi programmi ta ’ predonazzjoni awtologa
Independent of erythropoietin treatment, thrombotic and vascular events may occur in surgical patients with underlying cardiovascular disease following repeated phlebotomy.
Indipendentement mill- kura b’ erythropoietin, avvenimenti trombotiċi u vaskulari jistgħu jseħħu f’ pazjenti kirurġiċi b’ mard kardjovaskulari diġà eżistenti wara flebotomija ripetuta.
Therefore, routine volume replacement should be performed in such patients.
Għalhekk, is - sostituzzjoni ta ’ rutina tal- volum għandha titwettaq f’ dawn il- pazjenti.
Patients scheduled for major elective orthopaedic surgery
Pazjenti skedati għal operazzjoni ortopedika elettiva maġġuri
In patients scheduled for major elective orthopaedic surgery, with a baseline haemoglobin of 10 to 13 g/ dl, the incidence of thrombotic/ vascular events (most of which were DVTs), in the overall patient population of the clinical trials, appeared to be similar across the different epoetin alfa dosing groups and placebo group, although the clinical experience is limited.
F’ pazjenti skedati għal operazzjoni ortopedika elettiva maġġuri, b’ emoglobina fil- linja bażi ta ’ minn 10 sa 13 g/ dl, l- inċidenza ta ’ episodji trombotiċi/ vaskulari (li l- maġġoranza tagħhom kienu DVTs), fil - popolazzjoni totali tal- pazjenti tal- provi kliniċi, dehret li kienet simili fil- gruppi ta ’ dożaġġi differenti b’ epoetin alfa u l- grupp tal- plaċebo, għalkemm l- esperjenza klinika hi limitata.
Moreover, in patients with a baseline haemoglobin of > 13 g/ dl, the possibility that epoetin alfa treatment may be associated with an increased risk of postoperative thrombotic/ vascular events cannot be excluded.
Barra minn hekk, f’ pazjenti b’ emoglobina fil- linja bażi ta ’ > 13 g/ dl, il- possibbiltà li l- kura b’ epoetin alfa tista ’ tkun assoċjata ma ’ riskju akbar ta ’ episodji trombotiċi/ vaskulari wara l- operazzjoni, ma tistax tiġi eskluża.
4.9 Overdose
4. 9 Doża eċċessiva
The therapeutic margin of epoetin alfa is very wide.
Il- marġini terapewtiku ta ’ epoetin alfa huwa wiesa ’ ħafna.
Overdose of epoetin alfa may produce effects that are extensions of the pharmacological effects of the hormone.
Doża eċċessiva ta ’ epoetin alfa tista ’ tipproduċi effetti li huma estensjonijiet ta ’ l- effetti farmakoloġiċi ta ’ l- ormon.
Phlebotomy may be performed if excessively high haemoglobin levels occur.
Tista ’ titwettaq flebotomija jekk iseħħu livelli għoljin iżżejjed ta ’ emoglobina.
Additional supportive care should be provided as necessary.
Kura oħra ta ’ sapport għandha tingħata kif meħtieġ.
PHARMACOLOGICAL PROPERTIES
TAGĦRIF FARMAKOLOĠIKU
5.1 Pharmacodynamic properties
5. 1 Tagħrif farmakodinamiku
Pharmacotherapeutic group: antianaemic, ATC code:
Kategorija farmakoterapewtika: anti- anemiċi, 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.
Eritropoetin hija glikoproteina li tistimula, bħala fattur li jistimula l- mitosi u ormon ta ’ differenzjar, il - formazzjoni ta ’ eritroċiti minn prekursuri tal- kompartiment taċ- ċellula stem.
The apparent molecular weight of erythropoietin is 32,000 to 40,000 dalton.
12 Il- piż molekulari apparenti ta ’ eritropoetin hu minn 32, 000 sa 40, 000 dalton.
The protein fraction of the molecule contributes about 58% and consists of 165 amino acids.
Il- frazzjoni tal- proteini tal- molekula tikkontribwixxi madwar 58% u hija ffurmata minn 165 aċidu amminiku.
The four carbohydrate chains are attached via three N-glycosidic bonds and one O-glycosidic bond to the protein.
L- erba ’ katini ta ’ karboidrati huma mqabbdin permezz ta ’ tliet rabtiet N- glikosidiċi u rabta O- glikosidika mal - proteina.
Epoetin alfa obtained by gene technology is glycosylated and is identical in its amino acid and carbohydrate composition to endogenous human erythropoietin that has been isolated from the urine of anaemic patients.
Epoetin alfa miksub b’ teknoloġija tal- ġeni huwa glikosilat u huwa identiku fil- kompożizzjoni tiegħu ta ’ aċidi amminiċi u karboidrati għall- eritropoetin endoġeniku umana li ġie iżolat mill- awrina ta ’ pazjenti anemiċi.
Binocrit has the highest possible purity according to the present state of the art.
Binocrit għandu l- ogħla purità possibbli skond l- aktar teknoloġija avvanzata fil- preżent.
In particular, no residues of the cell line used for the production are detectable at the concentrations of the active ingredient that are used in humans.
B’ mod partikulari, l- ebda residwi tal- linja taċ- ċelluli użati għall- produzzjoni ma jkunu osservati fil - konċentrazzjonijiet tas- sustanza attiva li jintużaw fil- bnedmin.
The biological efficacy of epoetin alfa has been demonstrated in various animal models in vivo (normal and anaemic rats, polycythaemic mice).
L- effikaċja bijoloġika ta ’ epoetin alfa intweriet f’ diversi mudelli ta ’ annimali in vivo (ġrieden normali u anemiċi, ġrieden poliċitemiċi).