qanastek/EMEA-V3 huggingface dataset:
For more information on biosimilar medicines, see the question-and-answer document here.
Għal iktar tagħrif dwar mediċini bijosimili, are d- dokument bil- mistoqsijiet u tweġibiet li jinsab hawn.
What is Retacrit used for?
Għal xiex jintuża Retacrit?
Retacrit is used to stimulate red blood cell production in the following situations: • to treat anaemia (low red blood cell counts) caused by chronic renal failure (long-term, progressive decrease in the ability of the kidneys to work properly) or other kidney problems, • to treat anaemia and reduce the need for blood transfusions in adults receiving chemotherapy for certain types of cancer, • to increase the amount of blood that patients with moderate anaemia can donate before surgery, so that their own blood can be given back to them during or after surgery.
Retacrit jintuża biex jistimula l- produzzjoni taċ- ċelloli tad- demm ħomor f’ dawn is- sitwazzjonijiet: • Biex jittratta l- anemija (għadd baxx ta ’ ċelloli ħomor) ikkawżata minn falliment kroniku tal- kliewi (tnaqqis progressiv, fit- tul fil- kapaċità tal- kliewi li jaħdmu kif suppost) jew ta ’ problemi oħra fil - kliewi, • Biex jittratta l- anemija u biex inaqqas il- ħtieġa għal trasfużjonijiet fl- adulti li jkunu qed jingħataw il- kemjoterapija għal ċerti tipi ta ’ kanċer, • Biex jiżdied l- ammont ta ’ demm li l- pazjenti b’ anemija moderata jkunu jistgħu jagħtu qabel operazzjoni, biex id- demm tagħhom ikun jista ’ jingħatalhom lura waqt jew wara operazzjoni.
How is Retacrit used?
Kif jintuża Retacrit?
Treatment with Retacrit must be initiated under the supervision of doctors who have experience in the management of patients with the conditions that the medicine is used for.
It- trattament b’ Retacrit għandu jinbeda taħt is- superviżjoni ta ’ tobba li jkollhom esperjenza fil- ġestjoni ta ’ pazjenti bil- kundizzjonijiet li għalihom tintuża l- mediċina.
For patients with kidney problems or about to undergo surgery, Retacrit must be injected intravenously (into a vein), while patients receiving chemotherapy receive it subcutaneously (under the skin).
Għal pazjenti bi problemi fil- kliewi li jkunu waslu biex jagħmlu operazzjoni, Retacrit għandu jiġi injettat fil- vina, waqt li l- pazjenti li jkunu qed jingħataw il- kemjoterapija jeħduha taħt il- ġilda.
The dose, the frequency of injection and how long it is used for depend on why Retacrit is being used, and are adjusted according to the patient’ s response.
Id- doża, il- frekwenza ta ’ l- injezzjoni u kemm iddum tingħata jiġu adattati skond ir- rispons tal- pazjent.
The iron levels of all patients should be checked before treatment to make sure that they are not deficient, and iron supplements should be used throughout treatment.
Il- livelli ta ’ ħadid fil- pazjenti kollha għandhom jiġu ċċekkjati qabel it- trattament biex ikun żgurat li dawn m’ humiex neqsin, u għandhom jintużaw supplimenti tal- ħadid matul it- trattament kollu.
For full details, see the Package Leaflet.
Għad- dettalji kollha, ara l- Fuljett ta ’ Tagħrif.
How does Retacrit work?
Kif jaħdem Retacrit?
A hormone called erythropoietin, which is produced by the kidneys, stimulates the production of red blood cells from the bone marrow.
Ormun magħruf bħala eritropojetina (erythropoietin), li jiġi prodott mill- kliewi, jistimula l - produzzjoni ta ’ ċelloli tad- ddemm ħomor mill- mudullun.
7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Fil- pazjenti li jkunu qed jingħataw il- kemjoterapija jew bi problemi bil- kliewi, l- anemija tista ’ tkun ikkawżata minn nuqqas ta ’ eritropojetina, jew minħabba li l- ġisem ma jkunx qed jirrispondi biżżejjed 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged In patients receiving chemotherapy or with kidney problems, anaemia can be caused by a lack of erythropoietin, or by the body not responding enough to the erythropoietin it has naturally.
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged għall- eritropojetina li jkollu b’ mod naturali.
In these cases, erythropoietin is used to replace the missing hormone or to increase red blood cell counts.
F’ dawn il- każi, l- eritropojetina tintuża biex tissostitwixxi l- ormun nieqes jew biex iżżid l- għadd ta ’ ċelloli tad- demm ħomor.
Erythropoietin can also be used before surgery to increase the number of red blood cells to help patients produce more blood for self-donation.
L- eritropojetina tista ’ tintuża wkoll qabel operazzjoni biex jiżdied l- għadd ta ’ ċelloli tad- demm ħomor biex jgħin lill- pazjenti jipproduċu iktar demm biex jingħata lura lilhom infushom.
The active substance in Retacrit, epoetin zeta, is a copy of human erythropoietin and works in exactly the same way as the natural hormone to stimulate red blood cell production.
Is- sustanza attiva f' Retacrit, epoetin zeta, hija kopja ta ’ l- eritropojetina umana u taħdem eżatt bl- istess mod bħall- ormun naturali biex tistimula l- produzzjoni taċ- ċelloli tad- demm ħomor.
The active substance in Retacrit, epoetin zeta, is produced by ‘ recombinant DNA technology’: it is made by a cell that has received a gene (DNA), which makes it able to produce erythropoietin.
Is- sustanza attiva f’ Retacrit, epoetin zeta, tiġi prodotta bit - ‘ teknoloġija rikombinanti tad- DNA ’: jiġi prodott minn ċellola li tkun irċeviet ġene (DNA), li jagħmilha kapaċi tipproduċi l- eritropojetina.
How has Retacrit been studied?
Kif ġie studjat Retacrit?
Retacrit was studied to show that it is comparable with the reference medicine, EPREX/ ERYPO, in experimental models and in humans.
Retacrit ġie studjat biex juri li jista ’ jitqabbel mal- mediċina tar- referenza, EPREX/ ERYPO, f’ mudelli sperimentali u fil- bniedem.
Retacrit, injected intravenously, was compared with the reference medicine in two main studies involving 922 patients who had anaemia associated with chronic renal failure requiring haemodialysis (a blood clearance technique).
Retacrit, injettat fil- vina, tqabbel mal- mediċina ta ’ referenza f’ żewġ studji ewlenin li fihom ħadu sehem 922 pazjent li jbatu minn anemija assoċjata ma ’ falliment kroniku tal- kliewi li jkun jeħtieġ l - emodijaliżi (teknika ta ’ depurazzjoni tad- demm).
The first study compared the effects of Retacrit with those of EPREX/ ERYPO in correcting red blood cell counts in 609 patients over 24 weeks.
L- ewwel studju qabbel l- effetti ta ’ Retacrit ma ’ dawk ta ’ EPREX/ ERYPO fil- korrezzjoni tal- għadd ta ’ ċelloli tad- demm ħomor f’ 609 pazjenti matul 24 ġimgħa.
The second study compared the effects of Retacrit with those of EPREX/ ERYPO in maintaining red blood cell counts in 313 patients.
It- tieni studju qabbel l- effetti ta ’ Retacrit ma ’ dawk ta ’ EPREX/ ERYPO fil- manteniment tal- għadd ta ’ ċelloli tad- demm fi 313- il pazjent.
All of the patients in the second study had been receiving treatment with EPREX/ ERYPO for at least three months before they were either switched to Retacrit or remained on EPREX/ ERYPO for 12 weeks.
Il- pazjenti kollha fit- tieni studju kienu ilhom jingħataw it- trattament b’ EPREX/ ERYPO għal ta ’ l- anqas tliet xhur qabel ma ’ qalbu għal Retacrit jew tħallew fuq EPREX/ ERYPO għal 12- il ġimgħa.
After that the two groups switched to receiving the other medicine for a further 12 weeks.
Wara, dawn iż- żewġ gruppi bdew jingħataw il - mediċina l- oħra għal 12- il ġimgħa oħra.
In both studies, the main measures of effectiveness were the levels of haemoglobin (a protein in red blood cells that carries oxygen around the body) during treatment, as well as the dose of epoetin received.
Fiż- żewġ studji, il- miżuri ewlenin tal- kejl ta ’ l- effikaċja kienu l- livelli ta ’ emoglobina (proteina fiċ- ċelloli tad- demm ħomor li ġġorr l- ossiġenu madwar il- ġisem) waqt it- trattament, kif ukoll id- doża ta ’ epoetina li jkunu ngħataw.
The company also presented the results of a study looking at the effects of Retacrit injected subcutaneously in 261 cancer patients taking chemotherapy.
Il- kumpanija ppreżentat ukoll ir- riżultati ta ’ studju li jħares lejn l- effetti ta ’ Retacrit injettat taħt il - ġilda f’ 261 pazjent bil- kanċer li kienu qed jieħdu l- kemjoterapija.
What benefit has Retacrit shown during the studies?
X’ inhu l- benefiċċju ta ’ Retacrit li ntwera f’ dawn l- istudji?
Retacrit was as effective as EPREX/ ERYPO in correcting and maintaining red blood cell counts.
Retacrit kien effikaċi daqs EPREX/ ERYPO fil- korrezzjoni u fil- manteniment tal- għadd ta ’ ċelloli tad - demm ħomor.
In the correction study, haemoglobin levels were around 11.6 g/ dl during the last four weeks of the study, having risen from around 8.0 g/ dl before treatment.
Fl- istudju tal- korrezzjoni, il- livelli ta ’ l- emoglobina kienu madwar 11. 6 g/ dl waqt l - aħħar erba ’ ġimgħat ta ’ l- istudju, wara li żdied minn madwar 8. 0 g/ dl qabel it- trattament.
In the study of patients already being treated with an epoetin, haemoglobin levels were maintained to the same extent when the patients were receiving Retacrit and when they were receiving EPREX/ ERYPO, at around 11.4 g/ dl.
Fl- istudju ta ’ pazjenti li diġà kienu qed jingħataw epoetina, il- livelli ta ’ l- emoglobina nżammu sa l- istess punt meta l- pazjenti kienu qed jirċievu EPREX/ ERYPO, f’ madwar 11. 4 g/ dl.
In both studies, the dose of epoetin received was similar with both medicines.
Fiż- żewġ studji, id- doża ta ’ epoetina li ngħatat kienet simili għaż- żewġ mediċini.
The study in patients receiving chemotherapy showed that Retacrit was also effective when it was injected subcutaneously, with similar improvements in haemoglobin levels as those reported in the scientific literature for other epoetins.
L- istudju f’ pazjenti li kienu qed jingħataw il- kemjoterapija wrew li Retacrit kien effikaċi wkoll meta jiġi injettat taħt il- ġilda, b’ titjib simili fil- livelli ta ’ emoglobina bħal dawk rappurtati fil- letteratura xjentifika ta ’ epoetini oħra.
What is the risk associated with Retacrit?
X’ inhu r- riskju assoċjat ma ’ Retacrit?
As with other medicines containing an epoetin, the most common side effect with Retacrit is an increase in blood pressure, which can sometimes lead to symptoms of encephalopathy (brain problems) such as sudden, stabbing migraine-like headache and confusion.
Bħall- mediċini l- oħrajn li jkun fihom epoetina, l- iktar effetti sekondarji komuni ma ’ Retacrit jinkludu żieda fil- pressjoni, li xi drabi tista ’ twassal għal sintomi ta ’ enċefalopatija (problemi fil- moħħ) bħal konfużjoni u uġigħ ta ’ ras jixbah lill- emikranja penetranti u f’ daqqa.
Retacrit can also lead to skin rash and flu-like symptoms.
Retacrit jista ’ jwassal għal raxx fil- ġilda u sintomi jixbhu lill- influwenza.
For the full list of all side effects reported with Retacrit, see the Package Leaflet.
Għal- lista sħiħa ta ’ effetti sekondarji rrappurtati ma ’ Retacrit, ara l- Fuljett ta ’ Tagħrif.
Retacrit should not be used in people who may be hypersensitive (allergic) to epoetin zeta or any of the other ingredients.
Retacrit m’ għandux jintuża minn persuni li jistgħu jkunu allerġiċi għal epoetin zeta jew għal kwalunkwe sustanza oħra.
It should also not be used in the following groups: • patients who have developed pure red cell aplasia (reduced or stopped red blood cell production) following treatment with any erythropoietin; • patients with hypertension (high blood pressure) that is not controlled; • patients about to undergo surgery who have severe cardiovascular (heart and blood vessel) problems including a recent heart attack or stroke; • patients who cannot receive medicines for the prevention of blood clots.
M’ għandux jintuża f’ dawn il- gruppi: • Pazjenti li jkunu żviluppaw aplasija pura taċ- ċelloli tad- demm ħomor (tnaqqis jew twaqqif tal - produzzjoni taċ- ċelloli tad- demm ħomor) wara t- trattament bi xi eritropojetina; • Pazjenti bi pressjoni għolja li ma tkunx kontrollata; • Pazjenti li jkunu waslu biex jiġu operati li jkollhom problemi kardjovaskulari (fil- qalb u fl- arterji u l- vini) attakk tal- qalb jew puplesija reċenti; • Pazjenti li ma jkunux jistgħu jingħataw mediċini għall- prevenzjoni tal- għoqod tad- demm.
Retacrit is not recommended for subcutaneous injection in the treatment of kidney problems because further studies are needed to make sure that this does not cause allergic reactions.
Retacrit mhux rakkomandat għall- injezzjoni taħt il- ġilda fit- trattament ta ’ problemi tal- kliewi minħabba li hemm bżonn ta ’ iktar studji biex ikun żgurat li dan ma jikkawżax reazzjonijiet allerġiċi.
Why has Retacrit been approved?
Għaliex ġie approvat Retacrit?
The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Retacrit has been shown to have a comparable quality, safety and efficacy profile to EPREX/ ERYPO.
EPREX/ ERYPO.
Therefore, the CHMP’ s view was that, as for EPREX/ ERYPO, the benefit outweighs the identified risks.
Għalhekk, skond il- fehma tal- CHMP, bħal fil- każ ta ’ EPREX/ ERYPO, il- benefiċċju jegħleb lir- riskju.
The Committee recommended that Retacrit be given marketing authorisation.
Il- Kumitat irrakkomanda li Retacrit jingħata l- awtorizzazzjoni għat- tqegħid fis- suq.
Which measures are being taken to ensure the safe use of Retacrit?
X’ miżuri qed jittieħdu biex ikun żgurat l- użu sigur ta ’ Retacrit?
The company that makes Retacrit will provide information packs for healthcare workers in all Member States, including information on the safety of the medicine.
Il- kumpanija li tagħmel Retacrit se tipprovdi pakketti ta ’ tagħrif għal min jaħdem fil- ħarsien tas- saħħa fl- Istati Membri kollha, li fihom ikun hemm tagħrif dwar is- sigurtà tal- mediċina.
Other information about Retacrit:
Tagħrif ieħor dwar Retacrit:
The European Commission granted a marketing authorisation valid throughout the EU for Retacrit to HOSPIRA Enterprises B. V. on 18 December 2007.
Il- Kummissjoni Ewropea tat l- awtorizzazzjoni għat- tqegħid fis- suq għal Retacrit valida madwar l- UE lil HOSPIRA Enterprises B. V. fit - 18 ta ’ Diċembru 2007.
The full EPAR for Retacrit can be found here.
L- EPAR sħiħ għal Retacrit jinsab hawn.
This summary was last updated in 11-2007.
Dan is- sommarju ġie appornat l- aħħar f’ Novembru ta ’ l- 2007.
1000 IU/ 0.3 ml
Retacrit 1000 IU/ 0. 3 ml
Subcutaneous or intravenous use
Użu għal taħt ilġilda jew għal ġolvini
2000 IU/ 0.6 ml
Retacrit 2000 IU/ 0. 6 ml
0.6 ml (3333 IU/ ml)
0. 6 ml (3333 IU/ ml)
3000 IU/ 0.9 ml
Retacrit 3000 IU/ 0. 9 ml
0.9 ml (3333 IU/ ml)
0. 9 ml (3333 IU/ ml)
4000 IU/ 0.4 ml
Retacrit 4000 IU/ 0. 4 ml
5000 IU/ 0.5 ml
Retacrit 5000 IU/ 0. 5 ml
6000 IU/ 0.6 ml
Retacrit 6000 IU/ 0. 6 ml
8000 IU/ 0.8 ml
Retacrit 8000 IU/ 0. 8 ml
10000 IU / 1.0 ml
Retacrit 10000 IU/ 1. 0 ml
10000 IU/ 1.0 ml
Retacrit 10000 IU/ 1. 0 ml
20000 IU/ 0.5 ml
Retacrit 20000 IU/ 0. 5 ml
0.5 ml (40000 IU/ ml)
0. 5 ml (40000 IU/ ml)
30000 IU/ 0.75 ml
30000 IU/ 0. 75 ml Soluzzjoni għall- injezzjoni
0.75 ml (40000 IU/ ml)
0. 75 ml (40000 IU/ ml)
40000 IU/ 1.0 ml
40000 IU/ 1. 0 ml
1.0 ml (40000 IU/ ml)
1. 0 ml (40000 IU/ ml) Siringa 1 mimlija għal- lest
20000 IU/ 0.5 ml
20000 IU/ 0. 5 ml
0.5 ml (40000 IU/ ml)
0. 5 ml (40000 IU/ ml) 4 siringi mimlijin għal- lest
0.5 ml (40000 IU/ ml)
0. 5 ml (40000 IU/ ml) 6 siringi mimlijin għal- lest
4 pre-filled syringes
4 siringi mimlijin għal- lest
1.0 ml (40000 IU/ ml)
1. 0 ml (40000 IU/ ml) 4 siringi mimlijin għal- lest
1.0 ml (40000 IU/ ml)
1. 0 ml (40000 IU/ ml) 6 siringi mimlijin għal- lest
Retacrit 1000 IU/ 0.3ml solution for injection in pre-filled syringe
Retacrit 1000 IU/ 0. 3 ml soluzzjoni għall- injezzjoni f’ siringa mimlija minn qabel
1 pre-filled syringe with 0.3 ml solution for injection contains 1000 international units (IU) epoetin zeta* (recombinant human erythropoietin).
Siringa waħda mimlija minn qabel b’ 0. 3 ml soluzzjoni għall- injezzjoni għandha 1000 unit internazzjonali (IU) epoetin zeta * (rikombinanti uman erythropoietin).
The solution contains 3333 IU Epoetin zeta per ml.
Is- soluzzjoni fiha 3333 IU Epoetin zeta kull ml.
*Produced by recombinant DNA technology in Chinese Hamster Ovary (CHO) cell line.
* Magħmul mit- teknoloġija rikombinanti DNA tal- linja ċellulari fl- Ovarju tal- Hamster Ċiniż (CHO).
Each pre-filled syringe contains 0.15 mg phenylalanine.
Kull siringa mimlija minn qabel fiha 0. 15 mg fenilalanin.
Solution for injection in pre-filled syringe.
Soluzzjoni għall- injezzjoni f’ siringa mimlija minn qabel.
Clear, colourless solution.
Soluzzjoni ċara u bla kulur.
− Treatment of symptomatic anaemia associated with chronic renal failure (CRF) in adult and paediatric patients: o Treatment of anaemia associated with chronic renal failure in adult and paediatric patients on haemodialysis and adult patients on peritoneal dialysis (See section 4.4). o Treatment of severe anaemia of renal origin accompanied by clinical symptoms in adult patients with renal insufficiency not yet undergoing dialysis (See section 4.4). − Treatment of anaemia and reduction of transfusion requirements in adult patients receiving chemotherapy for solid tumours, malignant lymphoma or multiple myeloma, and at risk of transfusion as assessed by the patient's general status (e. g. cardiovascular status, pre-existing anaemia at the start of chemotherapy). − Retacrit can be used to increase the yield of autologous blood from patients in a predonation programme.
− Trattament għal anemija sintomatika assoċjata ma ’ falliment renali kroniku (CRF) f’ pazjenti adulti u tfal: o Trattament għal anemija assoċjata ma ’ falliment renali kroniku f’ pazjenti adulti u tfal fuq emodijalisi u pazjenti adulti fuq dijalisi peritoneali (Ara sezzjoni 4. 4). o Trattament għal anemija severa li ġejja mill- kliewi akkumpanjata minn sintomi kliniċi f’ pazjenti adulti b’ insuffiċjenza tal- kliewi li għad mhux ikollhom dijalisi (Ara sezzjoni 4. 4). − Trattament ta ’ anemija u nuqqas ta ’ bżonnijiet ta ’ trasfużjoni f’ pazjenti adulti li qegħdin jirċievu l- kimoterapija għal tumuri solidi, limfoma malinn jew myeloma multiplu, u f’ riskju ta ’ trasfużjoni kif assessjat mill- istatus ġenerali tal- pazjent (e. g. status kardjovaskulari, anemija pre - eżistenti fil- bidu tal- kimoterapija). − Retacrit jista ’ jintuża sabiex tiżdied il- ġabra ta ’ demm awtologu minn pazjenti li qegħdin f’ programm ta ’ qabel id- donazzjoni.
Its use in this indication must be balanced against the reported risk of thromboembolic events.
L- użu tiegħu f’ dan il- waqt għandu jkun ibbillanċjat kontra r- riskju rappurtat ta ’ waqtiet tromboemboliċi.
Treatment should only be given to patients with moderate anaemia (no iron deficiency), if blood saving procedures are not available or insufficient when the scheduled major elective surgery requires a large volume of blood (4 or more units of blood for females or 5 or more units for males).
It- trattament għandu jingħata biss lil dawk il - pazjenti b’ anemija moderata (li m’ għandhomx nuqqas ta ’ ħadid), jekk il- proċeduri tat- tifdil tad - demm mhumiex disponibbli jew mhux biżżejjed meta l- intervent ewlieni kururġiku ppjanat għandu bżonn volum kbir ta ’ demm (4 jew iżjed unità ta ’ demm għan- nisa jew 5 jew iżjed unità għall- irġiel).
Treatment with Retacrit has to be initiated under the supervision of physicians experienced in the management of patients with above indications.
It- trattament b’ Retacrit għandu jibda taħt superviżjoni ta ’ tobba b’ esperjenza fil- kura tal- pazjenti bl - indikazzjonjiet ta ’ hawn fuq.
Treatment of symptomatic anaemia in adult and paediatric chronic renal failure patients In patients with chronic renal failure the medicinal product has to be administered intravenously (see section 4.4)
− Trattament għal anemija sintomatika f’ pazjenti adulti u tfal b’ falliment renali kroniku.
2 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).
F’ pazjenti b’ falliment renali kroniku l- prodott mediċinali għandu jingħata minn ġol- vina (ara sezzjoni 4. 4) 2 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).
The upper limit of the target haemoglobin concentration should not be exceeded.
Il- limitu ta ’ fuq tal- konċentrazzjoni tal- emoglobina mixtieqa m’ għandux jiġi maqbuż.
Anemia symptoms and sequaelea may vary with age, gender and overall burden of disesase; a physician´s evaluation of the individual patient´s clinical course and condition is necessary.
Is- sintomi ta ’ anemija u sequaelea jistgħu jvarjaw skond l- età, il- ġeneru u l- qawwa globali tal- mard; evalwazzjoni mit- tabib tal- kors kliniku u l- kundizzjoni individwali tal- pazjent hi meħtieġa.
Retacrit should be administered intravenously in order to increase haemoglobin to not greater than 12 g/ dL (7.5 mmol/ L) Due to intra-patient variability, occasional individual haemoglobin values for a patient above and below the desired haemoglobin level may be observed.
Kull tant żmien, minħabba l- varjabilità bejn pazjent u ieħor, jiġu osservati valuri individwali tal- emoglobina li jkunu ’ l fuq jew ’ l isfel mil- livell mixtieq tal- emoglobina.
Haemoglobin variability should be addressed through dose management, with consideration for the haemoglobin target range of 10 g/ dL (6.2 mmol/ l) to 12 g/ dl (7.5 mmol/ l).
Il- varjabilità tal - emoglobina għandha tiġi indirizzata permezz tal- ġestjoni tad- doża, b’ kunsiderazzjoni għal medda mmirata għall- emoglobina ta ’ bejn 10 g/ dL (6. 2 mmol/ l) sa 12 g/ dl (7. 5 mmol/ l)
A sustained haemoglobin level of greater than 12 g/ dl should be avoided; guidance for appropriate dose adjustment for when haemoglobin values exceeding 12 g/ dl (7.5 mmol/ l) are observed are described below.
Livell sostnut tal- emoglobina ta ’ mhux aktar minn 12 g/ dl għandu jiġi evitat; gwida għal aġġustament tad- doża għal meta l- valuri tal- emoglobina jaqbżu 12 g/ dl (7. 5 mmol/ l) jiġu osservati huma deskritti hawn isfel.
A rise in haemoglobin of greater than 2 g/ dL (1.25 mmol/ l) over a four week period should be avoided.
Għandu jiġi evitat li jkun hemm żieda fil- livell tal- emoglobina ta ’ aktar minn 2 g/ dL (1. 25 mmol/ l) fuq perijodu ta ’ erba ’ ġimgħat.
If it occurs, appropriate dose adjustment should be made as provided.
Jekk dan iseħħ, għandu jsir aġġustament fid- doża kif ipprovdut.
Patients should be monitored closely to ensure that the lowest approved dose of Retacrit is used to provide adequate control of the symptoms of anemia.
Pazjenti għandhom jiġu monitorati mill- qrib sabiex jiġi żgurat li tingħata biss l- anqas doża approvata ta ’ Retacrit sabiex ikun hemm kontroll adegwat għas- sintomi ta ’ l- anemija.
In patients with chronic renal failure and clinically evident ischemic heart disease or congestive heart failure, maintenance haemoglobin concentration should not exceed the upper limit of the target haemoglobin concentration.
F’ pazjenti b’ nuqqas renali kroniku u l- mard tal- qalb iskematiku kliniku jew insuffiċjenza kongestiva fil- qalb, iż- żamma tal- livell tal- emoglobona m’ għandhiex taqbeż il- limitu ta ’ fuq tal- mira tal - koncentrazzjoni tal- emoglobina.
Adult patients on haemodialysis The treatment is divided into two stages:
Pazjenti adulti fuq l- emodijalisi It- trattament huwa maqsum f’ żewġ stadji:
Correction phase:
Il- fażi ta ’ korrezzjoni:
50 IU/ kg 3 times per week by the intravenous route.
50 IU/ kg 3 darbiet fil- ġimgħa, ġol- vina.
When a dose adjustment is necessary, this should be done in steps of at least four weeks.
Meta aġġustament ta ’ doża huwa neċessarju, dan għandu jsir fuq tul ta ’ madwar erba ’ ġimgħat mill- anqas.
Maintenance phase:
Il- fażi ta ’ manteniment:
Dose adjustment in order to maintain haemoglobin (Hb) values at the desired level:
Aġġustament fid- doża sabiex jinżammu il- valuri tal- emoglobina (Hb) fuq livell mixtieq:
Hb between 10 and 12 g/ dl (6.2-7.5 mmol/ l).
Hb bejn l- 10 u t- 12 g/ dl (6. 2- 7. 5 mmol/ l).
The recommended total weekly dose is between 75 and 300 IU/ kg by the intravenous route.
Id- doża rrakkomandata fil- ġimgħa hija ta ’ bejn il- 75 u t- 300 IU/ kg, ġol- vina.
The clinical data available suggest that those patients whose initial haemoglobin is very low (< 6 g/ dl or< 3.75 mmol/l) may require higher maintenance doses than those whose initial anaemia is less severe (Hb > 8 g/dl or> 5 mmol/l).
Id- data klinika tagħti x’ tifhem li dawk il- pazjenti li l- emoglobina inizjali tagħhom hija baxxa ħafna (< 6 g/ dl or < 3. 75 mmol/ l) jista ’ jkun li jkollhom bżonn dożi ta ’ manteniment ogħla minn dawk li l - anemija inizjali tagħhom hija anqas severa (Hb > 8 g/ dl or > 5 mmol/ l).
Paediatric patients on haemodialysis The treatment is divided into two stages:
Pazjenti pedjatriċi fuq l- emodijalisi It- trattament huwa maqsum f’ żewġ stadji:
Correction phase
Il- fażi ta ’ korrezzjoni:
50 IU/ kg, 3 times per week by the intravenous route.
50 IU/ kg, 3 darbiet fil- ġimgħa ġol- vina.
When a dose adjustment is necessary, this should be done in steps of 25 IU/ kg, 3 times per week at intervals of at least 4 weeks until the desired goal is achieved.
Meta aġġustament fid- doża huwa, neċessarju, dan dan għandu jsir fi stadji ta ’ 25 IU/ kg, 3 darbiet fil - ġimgħa f’ intervalli ta ’ mill- anqas 4 gimgħat sakemm l- iskop mixtieq jintlaħaq.
Dose adjustment in order to maintain haemoglobin (Hb) values at the desired level:
Aġġustament tad- doża sabiex jinżammu l- valuri ta ’ l- emoglobina (Hb) fuq livell mixtieq:
Hb between 9.5 and 11 g/ dl (5.9-6.8 mmol/ l).
Hb bejn id- 9. 5 u l- 11 g/ dl (5. 9- 6. 8 mmol/ l).
Generally, children and adolescents under 30 kg body weight require higher maintenance doses than adults and children over 30 kg.
Ġeneralment, fit- tfal u fl- adolexxenti b’ piż ta ’ anqas minn 30 kg għandhom bżonn dożi ogħla ta ’ manteniment minn tfal ta ’ aktar minn 30 kg u adulti.
The following maintenance doses were observed in clinical trials after 6 months of treatment.
Id- dożi ta ’ manteniment li ġejjin ġew osservati fi provi kliniċi wara 6 xhur ta ’ trattament.
Dose (IU/ kg given 3x week)
3 Doża (UI/ kg mogħtija 3x fil- ġimgħa)
Weight (kg )< 10 10-30 > 30
Toqol (kg) < 10 10- 30 > 30
Median 100 75 33
Medju 100 75 33
Usual maintenance dose 75-150 60-150 30-100
Doża ta ’ manteniment normali 75- 150 60- 150 30- 100
3 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).
Adult patients on peritoneal dialysis The treatment is divided into two stages:
Pazjenti adulti fuq dijalisi peritonjali It- trattament huwa maqsum f’ żewġ stadji:
Starting dose of 50 IU/ kg 2 times per week by the intravenous route.
Doża tal- bidu ta ’ 50 IU/ kg 2 fil- ġimgħa, ġol- vina.
Dose adjustment in order to maintain haemoglobin (Hb) values at the desired level:
Doża aġġustata sabiex jinżammu l- valuri tal- emoglobina (Hb) fuq livell mixtieq:
Hb between 10 and 12 g/ dl (6.2-7.5 mmol/ l).
(Hb bejn l- 10 u t- 12 g/ dl (6. 2- 7. 5 mmol/ l).
Maintenance dose between 25 and 50 IU/ kg 2 times per week into 2 equal doses.
Doża ta ’ manteniment bejn il- 25 u l- 50 IU/ kg 2 fil- ġimħa f’ żewġ injezzjonijiet ugwali.
Adult patients with renal insufficiency not yet undergoing dialysis
− Pazjenti adulti b’ insuffiċjenza tal- kliewi li jkunu għadhom mhux qegħdin fuq id- dijalisi
The treatment is divided into two stages:
It- trattament huwa maqsum f’ żewġ stadji:
Starting dose of 50 IU/ kg 3 times per week by the intravenous route, followed if necessary by a dose increase with 25 IU/ kg increments (3 times per week) until the desired goal is achieved (this should be done in steps of at least four weeks).
Doża tal- bidu ta ’ 50 IU/ kg 3 darbiet fil- ġimgħa, ġol- vina, segwit jekk hemm bżonn minn żieda fid- dożi b’ 25 IU/ kg (3 darbiet fil- ġimgħa) sakemm l- għan mixtieq jintlaħaq (dan għandu jsir fi stadji ta’ minn ta ’ l - anqas erba ’ ġimgħat).
Maintenance dose between 17 and 33 IU/ kg 3 times per week by the intravenous route.
Doża ta ’ manteniment bejn s- 17 u t- 33 IU/ kg 3 darbiet fil- ġimgħa, ġol- vina.
The maximum dose should not exceed 200 IU/ kg 3 times per week.
Id- doża massima m’ għandhiex taqbeż il- 200 IU/ kg 3 darbiet fil- ġimgħa.
− Treatment of patients with chemotherapy induced anaemia..
− Trattament ta ’ pazjenti għal anemija sensitizzata bil- kimoterapija
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).
Anaemia symptoms and sequelae may vary with age, gender, and overall burden of disease; a physician´s evaluation of the individual patient´s clinical course and condition is necessary.
Is- sintomi ta ’ l- anemija u sequelae jistgħu jvarjaw skond l- età, il- ġeneru u l- qawwa globali tal- marda; evalwazzjoni mit- tabib tal- kors kliniku u l- kundizzjoni individwali tal - pazjent hi meħtieġa.
Due to intra-patient variability, occasional individual haemoglobin values for a patient above and below the desired haemoglobin level may be observed.
Kull tant żmien, minħabba differenzi bejn pazjent u ieħor, jiġu osservati valuri individwali tal - emoglobina li jkunu ’ l fuq jew ’ l isfel mil- livell mixtieq tal- emoglobina.
Haemoglobin variability should be addressed through dose management with consideration for the haemoglobin target range of 10 g/ dl (6.2 mmol/ l) to 12 g/ dl (7.5 mmol/ l).
Il- differenza tal- emoglobina għandha tiġi indirizzata permezz tal- ġestjoni tad- doża, b’ konsidrazzjoni għal medda mixtieqa għall - emoglobina ta ’ bejn 10 g/ dL (6. 2 mmol/ l) sa 12 g/ dl (7. 5 mmol/ l).
A sustained haemoglobin level of greater than 12 g/ dl (7.5 mmol/ l) should be avoided; guidance for appropriate dose adjustment for when haemoglobin values exceeding 12 g/ dl (7.5 mmol/ l) are observed are described below.
Livell sostnut ta ’ emoglobina ta ’ mhux aktar minn 12 g/ dl (7. 5 mmol/ l) għandu jiġi evitat; gwida għal aġġustament tad- doża għal meta l- valuri tal- emoglobina jaqbżu 12 g/ dl (7. 5 mmol/ l) jiġu osservati huma deskritti hawn isfel.
Patients should be monitored closely to ensure that the lowest approved dose of Retacrit is used to provide adequate control of the symptoms of anaemia.
Pazjenti għandhom jiġu monitorati mill- qrib sabiex jiġi żgurat li tintuża biss l- anqas doża approvata ta ’ Retacrit biex tipprovdi kontroll adegwat għas- sintomi ta ’ l- anemija.
Retacrit therapy should continue until one month after the end of chemotherapy.
It- terapija b’ Retacrit għanda tibqa ’ sa xahar wara t- tmiem tal- kimoterapija.
The initial dose is 150 IU/ kg given subcutaneously 3 times per week.
Id- doża tal- bidu hija ta ’ 150 IU/ kg mogħtija taħt il- ġilda 3 darbiet fil- ġimgħa.
Alternatively, Retacrit can be administered at an initial dose of 450 IU/ kg subcutaneously once weekly.
Jew inkella, Retacrit jista ’ jingħata f’ doża tal- bidu ta ’ 450 IU/ kg taħt il- ġilda darba fil- ġimgħa.
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.
4 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.
However, if the haemoglobin
Hb mixtieq
4 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.
għal 4 ġimgħat
The recommended dosing regimen is described in the following diagram:
Żieda fl- għadd ta ’ retikuloċiti ≥ 40, 000/ μl jew żieda fl- Hb ≥ 1 g/ d
Once the therapeutic objective for an individual patient has been achieved, the dose should be reduced by 25 to 50% in order to maintain haemoglobin at that level.
Ġaladarba l- għan terapewtiku ta ’ pazjent individwali ikun intlaħaq, id- doża għandha titnaqqas b ’ 25% sa 50% sabiex l- emoglobina tinżamm f’ dak il- livell.
Appropriate dose titration should be considered.
Tittrazzjoni xierqa tad- doża għandha tiġi kkonsidrata.
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%.
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%.
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.
Jekk il- livell tal- emoglobina jaqbeż it- 12 g/ dl (7. 5 mmol/ l), it- terapija għanda tieqaf sakemm tinżel għal 12 g/ dl (7. 5 mmol/ l) jew inqas u mbgħad erġa agħti t- terapija tas- Retacrit f’ doża ta ’ 25% anqas mid- doża ta ’ qabel.
− Adult surgery patients in an autologous predonation programme.
− Pazjenti kirurġiċi f’ programmi predonazzjoni awtologi
Retacrit should be given by the intravenous route.
Retacrit għandu jingħata fil- vina.
At the time of donating blood, Retacrit should be administered after the completion of the blood donation procedure.
Fil- mument ta ’ donazzjoni tad- demm, Retacrit għandu jingħata wara t- tlestija tal- proċedura tad - donazzjoni tad- demm.
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 6 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.
5 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.
200 mg oral elemental iron daily) throughout the course of treatment.
200 mg ħadid elementali orali kuljum) matul iż- żmien tat- trattament.
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 Retacrit therapy.
Is - suplimentazzjoni tal- ħadid għandha tibda mill- aktar fis possibli, anke diversi ġimgħat qabel ma jibda id- depożitu awtologu ta ’ qabel, sabiex jilħaq jinġemgħu livelli ta ’ kwantità ta ’ ħadid qabel ma tibda ’ it- terapija b’ Retacrit.
Intravenous injection The dose should be administered over at least 1-5 minutes, depending on the total dose.
Injezzjoni fil- vini Id- doża għandha tingħata fuq medda ta ’ mill- anqas 5 minuti, skond id- doża sħiħa.
In haemodialysed patients, a bolus injection may be given during the dialysis session through a suitable venous port in the dialysis line.
F’ pazjenti emodijalizzati, injezzjoni kbira tista ’ tingħata matul is- sessjoni ta ’ dijalisi permezz ta ’ port adattat venuż 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 sodium chloride 9 mg/ ml (0.9%) solution for injection to rinse the tubing and ensure satisfactory injection of the medicinal product into the circulation.
B’ mod alternattiv, l- injezzjoni tista ’ tingħata fit- tmiem tas- sessjoni tad - dijalisi permezz ta ’ tubi tal- labra fistla, segwit minn 10 ml ta ’ soluzzjoni għall- injezzjoni ta ’ sodium chloride 9 mg/ ml (0. 9%) biex tlaħlaħ it- tubi u tassigura 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 aktar mixtieqa f’ pazjenti li jirreaġixxu għat- trattament b’ sintomi “ qishom tal- influwenza ”.
Retacrit must not be mixed with other medicinal products (see section 6.2).
Retacrit m’ għandux jingħata f’ infużjoni fil- vini, jew imħallat ma ’ prodotti oħra mediċinali (ara sezzjoni 6. 2).
Subcutaneous injection A maximum volume of 1 ml at one injection site should generally not be exceeded.
Injezzjoni taħt il- ġilda Ġeneralment, volum massimu ta ’ 1 ml f’ post wieħed ta ’ injezzjoni m’ għandux jinqabeż.
In case of larger volumes, more than one site should be chosen for the injection.
F’ każ ta ’ volumi akbar, aktar minn post wieħed għandu jintgħażel għall- injezzjoni.
The injections are given in the limbs or the anterior abdominal wall.
L- injezzjonijiet jingħataw fir- riġlejn jew dirgħajn jew fil- parti ta ’ quddiem tal- ħajt addominali.
In chronic renal failure patients Retacrit has not to be administered subcutaneously.
F’ pazjenti b’ nuqqas kroniku renali Retacrit m’ għandux ikun amministrat minn taħt il- ġilda.
The intravenous route has to be used (please see section 4.4 - chronic renal failure patients).
Ir- rotta fil - vina għandha tintuża (ara sezzjoni 4. 4 – pazjenti b’ insuffiċjenza renali kronika).
4.3 Contraindications
4. 3 Kontra- indikazzjonjiet
− Hypersensitivity to the active substance or to any of the excipients. − Patients who develop Pure Red Cell Aplasia (PRCA) following treatment with any erythropoietin must not receive Retacrit or any other erythropoietin (see section 4.4). − Uncontrolled hypertension. − 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. − Patients who for any reason cannot receive adequate antithrombotic prophylaxis.
− Sensittività eċċessiva għas- sustanza attiva jew għal xi sustanzi mhux attivi. − Pazjenti li jiżviluppaw Pure Red Cell Aplasia (PRCA) wara trattament b’ xi eritropojetin m’ għandux jirċievi Retacrit jew kwalunkwe eritropojetin ieħor (ara sezzjoni 4. 4). − Pressjoni għolja mhix ikkontrollata. − Fl- indikazzjoni "żieda fil- ġabra ta ’ demm awtologiku": infart mijokardjali jew puplesija fix - xahar ta ’ qabel jibda ’ it- trattament, anġina pectoris instabbli, żieda fir- risku ta ’ trombosi fil- vini profondi bħal ma hija storja personali ta ’ mard tromboemboliku venuż. − Pazjenti li għal xi raġuni ma jistgħux jirċievu profilassi antitrombotika adegwata.
Like in all patients receiving erythropoietin, blood pressure may rise during treatment with Retacrit.
Bħal f’ pazjenti kollha li jirċievu l- eritropojetin, il- pressjoni tad- demm tista ’ titla ’ matul it- trattament b’ Retacrit.
Blood pressure should be closely monitored and adequately controlled in all epoetin treatment naïve as well as pre-treated patients before, at initiation of, and during treatment with Retacrit.
Il- pressjoni tad- demm għandha tiġi moniterjata mill- qrib u kkontrollata adegwatament fit - trattament tal- epoetin naïve kif ukoll f’ pazjenti ttrattati minn qabel, fil- bidu ta ’, u matul it- trattament b’ Retacrit.
It may be necessary to add or increase anti-hypertensive treatment.
Jista ’ jinħtieġ li jiżdied it- trattament ta ’ kontra il- pressjoni tad- demm.
If blood pressure cannot be well controlled, Retacrit treatment should be discontinued.
Jekk il- pressjoni tad - demm ma tkunx tista ’ tiġi kkontrollata, it- trattamanet b’ Retacrit għandu jitwaqqaf.
Retacrit should also be used with caution in the presence of epilepsy and chronic liver failure.
Retacrit għandu jintuża wkoll bil- galbu fil- presenza ta ’ epilessija u insuffiċjenza kronika tal- fwied.
There may be a moderate dose-dependent rise in the platelet count within the normal range during treatment with erythropoietin.
7 Jista ’ ikun hemm żieda moderata, li tiddependi mid- doża, fl- għadd tal- plejtlits fil- limiti normali matul it- trattament bl- eritropojetin.
This regresses during the course of continued therapy.
Dan jonqos matul it- terapija kontinwa.
It is recommended that the platelet count is regularly monitored during the first 8 weeks of therapy.
Huwa rrakomandat li l- għadd tal - plejtlits jiġi osservat regolarment matul l- ewwel 8 ġimgħat ta ’ terapija.
6 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.
In most cases, the ferritin values in the serum fall simultaneously with the rise in packed cell volume.
Fil- biċċa l- kbira tal- każijiet, il- valuri tal- ferritin fis- serum jaqgħu fl- istess waqt li jiżdied il- volum taċ - ċelluli ppakjati.
In order to ensure optimum response to erythropoietin, adequate iron stores should be assured: − iron supplementation, e. g.
Sabiex jiġi assigurat rispons ottimali għall- eritropojetin, ammonti adegwati ta ’ ħadid fil- ġsem għadhom jiġu assigurati: − Supplementazzjoni bil- ħadid, e. g.
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 transferrin saturation is below 20%.
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%
All of these additive factors of anaemia should also be carefully considered when deciding to increase the dose of erythropoietin in cancer patients.
Dawn il- fatturi kollha flimkien tal- anemija għandhom jiġi kkunsidrati mill- qrib meta wieħed ikun qed jiddeċiedi d- doża ta ’ eritropojetin fil- pazjenti bil- kanċer.
Good blood management practices should always be used in the perisurgical setting.
Tħaddim ta ’ prassi tajba fl- immaniġġjar tad- demm għandhom dejjem jintużaw fi sfond perikirurġiku.
This medicinal product contains phenylalanine which may be harmful for people with phenylketonuria.
Dan il- prodott mediċinali fih il- fenilalanin li jista ’ jkun ta ’ ħsara għan- nies li għandhom il - fenilketonurja.
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 ta ’ sodju (23 mg) kull doża, i. e. essenzjalment ‘ bla sodju ’.
Chronic renal failure patients
Pazjenti li għandom insuffiċjenzarenali kronika
Immunogenicity data for subcutaneous use of Retacrit in patients at risk for antibody-induced Pure Red Cell Aplasia (PRCA), i. e. patients with renal anaemia, are not sufficient.
Id- data tal- immunogeniċità għall- użu ta ’ Retacrit taħt il- ġilda f’ pazjenti b’ riskju ta ’ Pure Red Cell Aplasia (PRCA) ġejja minn antikorpi, i. e. pazjenti b’ anemija renali, mix 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 jiġi amministrat fil- vina.
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.
F’ pazjenti li għandhom insuffiċjenza renali kronika, il- konċentrazzjoni ta ’ manteniment tal - emoglobina m’ għandiex taqbeż il- limitu ta ’ fuq tal- konċentrazzjoni tal- emoglobina mixtieqa 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, riskju ogħla ta ’ mewt u każijiet kardjovaskulari serji kienu osservati meta sustanzi li jistimulaw l- eritropojesi (ESAs) ġew mogħtija sabiex jintlaħaq livell ta ’ emoglobina li hu ogħla 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 b’ kontrolli ma wrewx benefiċċji sinifikanti li jistgħu jkunu attribwiti għall- għoti ta ’ epoetins meta l- konċentrazzjoni tal- emoglobina togħla aktar ’ l fuq mil- livell meħtieġ sabiex jiġu kontrollati sintomi ta ’ anemija u sabiex jiġi evitat it- trasfużjoni tad- demm.
Haemoglobin levels should be measured on a regular basis 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.
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.
Ir- rata fiż- żieda tal- emoglobina għanda tkun bejn wieħed u ieħor ta ’ 1 g/ dl (0. 62 mmol/ l) kull xahar u m’ għandiex taqbeż iż- 2 g/ dl (1. 25 mmol/ l) kull xahar sabiex jitnaqqas ir - riskju li tiżviluppa jew tiżdied il- pressjoni għolja.
Non response to erythropoietin therapy should prompt a search for causative factors.
In- nuqqas ta ’ rispons għat- terapija bl- eritropojetin għandu iwassal għal tfitxxija ta ’ fatturi kawżattivi.
These include: iron, folate, or Vitamin B12 deficiency; aluminium intoxication; intercurrent infections; inflammatory or traumatic episodes; occult blood loss; haemolysis, and bone marrow fibrosis of any origin.
Dawn jinkludu: deifiċjenza fil- ħadid, fil- folate, jew fil- Vitamina B12; intossikazzjoni bl- aluminju; infezzjonijiet interkurrenti; episodji ta ’ infjammazzjoni jew trawmatiċi; telf ta ’ demm moħbi; emolisi, fibrożi tal- muddullun ta ’ kwalunkwe oriġini.
Cases of antibody-mediated PRCA have been very rarely reported in chronic renal failure patients with erythropoietin administered by the subcutaneous route.
Każijiet ta ’ PRCA ġejjin minn antikorpi huma rari ħafna f’ pazjenti b ’ insuffiċjenza renali kronika bl - erythropojetin amministrat minn taħt il- ġilda..
In patients developing sudden lack of efficacy, defined by a decrease in haemoglobin (1-2 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 juru nuqqas f’ daqqa ta ’ effikaċja, li tidher permezz ta ’ nuqqas fl- emoglobina (1- 2 g/ dl per month) b’ żieda ta ’ bżonn ta ’ trasfużjonijiet, l- għadd tar- retikuloċiti għandu jittieħed u kawżi tipiċi ta ’ nuqqas ta ’ rispons (eż defiċjenza fil- ħadid, folate jew il- Vitamina B12, intossikament bl- alumilju, infezzjoni jew infjammazzjoni, telf ta ’ demm, u emolisi) għandhom jiġu investigati.
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 8 eżaminazzjoni tal- mudullun għad- dijanjosi tal- PRCA.
Patients should not be switched to another medicinal
Jekk il- PRCA huwa ddijanjostikat, it- terapija b’ Retacrit trid titwaqqaf immedjatament u ttestjar għall - antikorpi tal- eritropojetin għandu jiġi kkunsidrat.