qanastek/EMEA-V3 huggingface dataset:
After administration of epoetin alfa, the number of erythrocytes, the Hb values and reticulocyte counts increase as well as the 59Fe-incorporation rate.
Wara li jingħataw epoetin alfa, in- numru ta ’ eritroċiti, il- figuri ta ’ Hb u l- għadd ta ’ retikuloċiti jiżdiedu l- istess kif tagħmel ir- rata ta ’ l- inkorporazzjoni ta ’ 59Fe.
An increased 3H-thymidine incorporation in the erythroid nucleated spleen cells has been found in vitro (mouse spleen cell culture) after incubation with epoetin alfa.
Inkorporazzjoni akbar ta ’ 3H- thymidine fiċ- ċelluli tal- milsa erythroid nucleated instabet in vitro (koltura taċ- ċelluli tal- milsa tal- ġurdien) wara inkubazzjoni b’ epoetin alfa.
It could be shown with the aid of cell cultures of human bone marrow cells that epoetin alfa stimulates erythropoiesis specifically and does not affect leucopoiesis.
Seta ’ jiġi muri bl- għajnuna ta ’ kolturi ta ’ ċelluli taċ- ċelluli tal- mudullun uman li epoetin alfa jistimula b’ mod speċifiku l- eritropoeżi u ma jaffettwax il- lewkopoeżi.
Cytotoxic actions of epoetin alfa on bone marrow cells could not be detected.
Ma setgħux jiġu osservati azzjonijiet ċitotossiċi ta ’ epoetin alfa fuq iċ- ċelluli tal- mudullun.
12 721 cancer patients receiving non-platinum chemotherapy were included in three placebo-controlled studies, 389 patients with haematological malignancies (221 multiple myeloma, 144 non-Hodgkin's lymphoma, and 24 other haematological malignancies) and 332 with solid tumours (172 breast, 64 gynaecological, 23 lung, 22 prostate, 21 gastro-intestinal, and 30 other tumour types).
721 pazjent morda bil- kanċer li kienu qegħdin jirċievu kimoterapija mhux bil- platinu kienu inklużi fi tliet studji kkontrollati bil- plaċebo, 389 pazjent b’ tumuri ematoloġiċi malinni (221 majeloma multipla, 144 limfoma mhux ta ’ Hodgkin, u 24 tumur ematoloġiku malinn ieħor) u 332 b’ tumuri solidi (172 tas - sider, 64 ġinekoloġiċi, 23 tal- pulmun, 22 tal- prostata, 21 gastro- intestinali, 30 tip ieħor ta ’ tumuri).
In two large, open-label studies, 2697 cancer patients receiving non-platinum chemotherapy were included, 1895 with solid tumours (683 breast, 260 lung, 174 gynaecological, 300 gastro-intestinal, and 478 other tumour types) and 802 with haematological malignancies.
F’ żewġ studji kbar open- label, kienu inklużi 2697 pazjent morda bil- kanċer li kienu qed jirċievu kimoterapija mhux bil- platinu, 1895 b’ tumuri solidi (683 tas- sider, 260 tal- pulmun, 174 ġinekoloġiċi, 300 gastro- intestinali, u 478 tip ieħor ta ’ tumuri) u 802 tumuri ematoloġiċi malinni.
Functional Assessment of Cancer Therapy- Anaemia (FACT-An) general scale, FACT-An fatigue scale, and Cancer Linear Analogue Scale (CLAS).
Fi studju prospettiv, ikkontrollat bil- plaċebo, tat- tip double- blind, u randomised fi 375 pazjent anemiku b’ tumuri malinni mhux majelojdi li kienu qed jirċievu kimoterapija mhux bil- platinu, kien hemm tnaqqis sinifikanti fis- sintomi relatati ma ’ l- anemija (eż. għeja, tnaqqis fl- enerġija, tnaqqis fl - attività), kif imkejla bl- istrumenti u l- iskali li ġejjin: l- iskala ġenerali ta ’ l- iStima Funzjonali ta ’ Anemija relatata mat- Terapija kontra l- Kanċer (FACT- An), l- iskala ta ’ l- għeja tal- FACT- An, u l - iSkala Lineari Analoga tal- Kanċer (CLAS).
Two other smaller, randomised, placebo-controlled trials failed to show a significant improvement in quality of life parameters on the EORTC-QLQ-C30 scale or CLAS, respectively.
Żewġ studji iżgħar, ikkontrollati bil- plaċebo, u randomised, naqsu li juru titjib sinifikanti fil- parametri tal- kwalità tal- ħajja fuq l- iskala EORTC- QLQ - C30 jew CLAS, rispettivament.
Erythropoietin is a growth factor that primarily stimulates red cell production.
L- eritropoetin hija fattur tat- tkabbir li jistimula 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- eritropoetin jistgħu jkunu espressi fuq il- wiċċ ta ’ diversi ċelluli tat- tumuri.
Survival and tumour progression have been examined in five large controlled studies involving a total of 2833 patients, of which four were double-blind placebo-controlled studies and one was an open- label study.
Is- sopravivenza u l- progressjoni tat- tumur kienu eżaminati f’ ħames studji kbar ikkontrollati, li kienu jinvolvu total ta ’ 2833 pazjent, li erba ’ minnhom kienu studji double- blind u kkontrollati bil- plaċebo, u wieħed kien studju open- label.
The studies either recruited patients who were being treated with chemotherapy (two studies) or used patient populations in which erythropoiesis stimulating agents are not indicated: anaemia in patients with cancer not receiving chemotherapy, and head and neck cancer patients receiving radiotherapy.
L- istudji kienu jinkludu jew pazjenti li kienu qed jiġu kkurati bil - kimoterapija (żewġ studji), jew użaw popolazzjoni ta ’ pazjenti li għalihom, sustanzi li jistimulaw l - eritropoeżi m’ humiex indikati: anemija f’ pazjenti bil- kanċer li ma kinux qed jirċievu kimoterapija, u pazjenti b’ kanċer fir- ras u fl- għonq li kienu qed jirċievu r- radjuterapija.
The target haemoglobin concentration in two studies was > 13 g/ dl; in the remaining three studies it was 12 - 14 g/ dl.
Il- konċentrazzjoni ta ’ l - emoglobina mmirata f’ żewġ studji kienet ta ’ > 13 g/ dl; fit- tliet studji l- oħrajn kienet ta ’ 12 - 14 g/ dl.
In the open-label study there was no difference in overall survival between patients treated with recombinant human erythropoietin and controls.
Fl- istudju open- label ma kien hemm l- ebda differenza fis- sopravivenza totali bejn pazjenti kkurati b’ eritropoetin uman rikombinanti u l- kontrolli.
In the four placebo-controlled studies the hazard ratios for overall survival ranged between 1.25 and 2.47 in favour of controls.
Fl- erba ’ studji kkontrollati bil- plaċebo, il - proporzjonijiet tal- periklu għas- sopravivenza totali varjaw bejn 1. 25 u 2. 47 favur il- kontrolli.
These studies have shown an consistent unexplained statistically significant excess mortality in patients who have anaemia associated with various common cancers who received recombinant human erythropoietin compared to controls.
Dawn l - istudji wrew mortalità eċċessiva konsistenti li kienet statistikament sinifikanti, u li ma kinitx spjegabbli, f’ pazjenti li kellhom anemija assoċjata ma ’ diversi kanċers komuni, li rċivew eritropoetin uman rikombinanti, meta mqabbla mal- kontrolli.
Overall survival outcome in the trials could not be statisfactorily explained by differences in the incidence of thrombosis and related complications between those given recombinant human erythropoietin and those in the control group.
Ir- riżultat totali tas- sopravivenza fil- provi ma setax ikun spjegat b’ mod sodisfaċenti mid- differenzi fl- inċidenza ta ’ trombożi u kumplikazzjonijiet marbuta bejn dawk il- pazjenti li ngħataw eritropoetin uman rikombinanti u dawk fil- grupp tal- kontroll.
A systematic review has also been performed involving more than 9000 cancer patients participating in 57 clinical trials.
13 Saret ukoll evalwazzjoni sistematika li kienet tinvolvi iktar minn 9000 pazjent bil- kanċer li kienu qed jipparteċipaw f’ 57 prova klinika.
Meta-analysis of overall survival data produced a hazard ratio point estimate of 1.08 in favour of controls (95% CI:
Meta- analiżi ta ’ l- informazzjoni dwar is- sopravivenza, ipproduċiet hazard ratio point estimate ta ’ 1. 08 favur il- kontrolli (95% CI:
0.99, 1,18; 42 trials and 8167 patients).
0. 99, 1. 18; 42 prova u 8167 pazjent).
An increased relative risk of thromboembolic events (RR 1.67, 95% CI:
Żieda relattiva fir- riskju ta ’ avvenimenti tromboemboliċi (RR 1. 67, 95% CI:
1.35, 2.06, 35 trials and 6769 patients) was observed in patients treated with recombinant human erythropoietin.
1. 35, 2. 06, 35 prova u 6769 pazjent) kienet osservata f’ pazjenti kkurati b’ eritropoetin uman rikombinanti.
There is an increased risk for thromboembolic events in patients with cancer treated with recombinant human erythropoietin and a negative impact on overall survival cannot be excluded.
Hemm żieda fir - riskju għal avvenimenti tromboemboliċi f’ pazjenti b’ kanċer li jkun ikkurat b’ eritropoetin uman rikombinanti, u impatt negattiv fuq is- sopravivenza totali ma jistax jiġi eskluż.
The extent to which these outcomes might apply to the administration of recombinant human erythropoietin to patients with cancer, treated with chemotherapy to achieve haemoglobin concentrations less than 13 g/ dl, is unclear because few patients with these characteristics were included in the data reviewed.
Il- grad sa fejn dawn ir - riżultati jistgħu japplikaw għall- għoti ta ’ eritropoetin uman rikombinanti lil pazjenti bil- kanċer, ikkurati bil- kimoterapija biex jintlaħqu konċentrazzjonijiet ta ’ emoglobina ta ’ inqas minn 13 g/ dl, mhuwiex ċar minħabba li ftit pazjenti b’ dawn il- karatteristiċi kienu inklużi fl- informazzjoni li kienet evalwata.
5.2 Pharmacokinetic properties
5. 2 Tagħrif farmakokinetiku
Intravenous route
Injezzjoni fil- vini
Measurement of epoetin alfa following multiple dose intravenous administration revealed a half-life of approximately 4 hours in normal volunteers and a somewhat more prolonged half-life in renal failure patients, approximately 5 hours.
Il- kejl ta ’ epoetin alfa wara l- għoti ta ’ diversi dożi fil- vina żvela half- life ta ’ madwar 4 sigħat f’ voluntiera normali u half- life kemmxejn itwal f’ pazjenti li kellhom insuffiċjenza tal- kliewi, ta ’ madwar 5 sigħat.
A half-life of approximately 6 hours has been reported in children.
Fit- tfal kienet irrappurtata half- life ta ’ madwar 6 sigħat.
Subcutaneous route
Injezzjoni taħt il- ġilda
Following subcutaneous injection, serum levels of epoetin alfa are much lower than the levels achieved following intravenous injection, the levels increase slowly and reach a peak between 12 and
Wara injezzjoni taħt il- ġilda, il- livelli ta ’ epoetin alfa fis- serum huma ħafna aktar baxxi mil- livelli miksuba wara injezzjoni fil- vina, il- livelli jiżdiedu bil- mod u jilħqu massimu ta ’ madwar 12 u 18- il siegħa wara d- doża.
The peak is always well below the peak achieved using the intravenous route (approximately 1/ 20th of the value).
Il- massimu hu dejjem ’ l isfel sewwa mill- massimu miksub bl- użu ta ’ injezzjoni fil- vini (madwar 1/ 20 tal- valur).
There is no accumulation: the levels remain the same, whether they are determined 24 hours after the first injection or 24 hours after the last injection.
M’ hemm l- ebda akkumulazzjoni: il- livelli jibqgħu l- istess, sew jekk jiġu stabbiliti 24 siegħa wara l - ewwel injezzjoni jew 24 siegħa wara l- aħħar injezzjoni.
The half-life is difficult to evaluate for the subcutaneous route and is estimated about 24 hours.
Il- half- life hija diffiċli biex tkun evalwata għall- injezzjoni taħt il- ġilda u hija stmata li hi ta ’ madwar 24 siegħa.
The bioavailability of subcutaneous injectable epoetin alfa is much lower than that of the intravenous medicinal product: approximately 20%.
Il- bijodisponibilità ta ’ epoetin alfa injettat minn taħt il- ġilda hija ferm aktar baxxa minn dik tal- prodott mediċinali għal ġol- vina: madwar 20%.
5.3 Preclinical safety data
5. 3 Tagħrif ta ’ qabel l- użu kliniku dwar is- sigurtà tal- mediċina
In some preclinical toxicological studies in dogs and rats, but not in monkeys, epoetin alfa therapy was associated with subclinical bone marrow fibrosis (bone marrow fibrosis is a known complication of chronic renal failure in humans and may be related to secondary hyperparathyroidism or unknown factors.
F’ xi studji tossikoloġiċi ta ’ qabel l- użu kliniku fil- klieb u l- firien, iżda mhux fix- xadini, it- terapija b’ epoetin alfa kienet assoċjata ma ’ fibrożi subklinika tal- mudullun (fibrożi tal- mudullun hija komplikazzjoni magħrufa ta ’ insuffiċjenza renali kronika fil- bniedem u tista ’ tkun marbuta ma ’ iperparatirojdiżmu sekondarju jew fatturi mhux magħrufa.
The incidence of bone marrow fibrosis was not increased in a study of haemodialysis patients who were treated with epoetin alfa for 3 years compared to a matched control group of dialysis patients who had not been treated with epoetin alfa.).
L- inċidenza ta ’ fibrożi tal- mudullun ma kinetx akbar fi studju ta ’ pazjenti fuq l- emodijalisi li ġew ikkurati b’ epoetin alfa għal 3 snin meta mqabbla ma ’ grupp ta ’ kontroll korrispondenti ta ’ pazjenti fuq dijalisi li ma kinux ġew ikkurati b’ epoetin alfa.).
In animal studies, epoetin alfa has been shown to decrease foetal body weight, delay ossification and increase foetal mortality when given in weekly doses of approximately 20 times the recommended human weekly dose.
Fl- istudji fuq l- annimali, epoetin alfa intwera li jnaqqas il- piż tal- ġisem tal- fetu, jittardja l - ossifikazzjoni u jżid il- mortalità tal- fetu meta jingħata f’ dożi kull ġimgħa ta ’ madwar 20 darba d- doża rakkomandata kull ġimgħa għall- bniedem.
These changes are interpreted as being secondary to decreased maternal body weight gain.
Dawn il- bidliet huma interpretati bħala konsegwenza tat - tnaqqis fiż- żieda tal- piż tal- ġisem ta ’ l- omm.
Epoetin alfa did not show any changes in bacterial and mammalian cell culture mutagenicity tests and an in vivo micronucleus test in mice.
Epoetin alfa ma wera ebda bidliet f’ testijiet tal- mutaġeniċità b’ kolturi ta ’ ċelluli tal- batterji u tal - mammali u f’ test mikronukleu in vivo fuq il- ġrieden.
Long-term carcinogenicity studies have not been carried out.
Ma sarux studji fuq perijodu fit- tul dwar il- karċinoġeniċità.
There are conflicting reports in the literature regarding whether erythropoietins may play a major role as tumour proliferators.
Hemm rapporti li ma jaqblux fil- letteratura dwar jekk l- eritropoetins jistax ikollhom rwol importanti bħala proliferaturi tat- tumuri.
These reports are based on in vitro findings from human tumour samples, but are of uncertain significance in the clinical situation.
Dawn ir - rapporti huma bbażati fuq sejbiet in vitro minn kampjuni ta ’ tumuri umani, iżda l- importanza tagħhom mhix ċerta fis- sitwazzjoni klinika.
PHARMACEUTICAL PARTICULARS
TAGĦRIF FARMAĊEWTIKU
6.1 List of excipients
6. 1 Lista ta ’ sustanzi mhux attivi
Sodium dihydrogen phosphate dihydrate Disodium phosphate dihydrate Sodium chloride Glycine Polysorbate 80 Water for injections Hydrochloric acid (for pH-adjustment) Sodium hydroxide (for pH-adjustment)
Sodium dihydrogen phosphate dihydrate Disodium phosphate dihydrate Sodium chloride Glycine Polysorbate 80 Ilma għall- injezzjonijiet Hydrochloric acid (għal aġġustament tal- pH) Sodium hydroxide (għal aġġustament tal- pH)
6.2 Incompatibilities
6. 2 Inkompatibilitajiet
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Minħabba li ma sarux studji li juru liema huma l- prodotti li ma jaqblux miegħu, dan il- prodott mediċinali m’ għandux jitħallat ma ’ prodotti mediċinali oħrajn.
6.3 Shelf life
6. 3 Żmien kemm idum tajjeb il- prodott mediċinali
2 years
Sentejn
6.4 Special precautions for storage
6. 4 Prekawzjonijiet speċjali għall- ħażna
Store and transport refrigerated (2°C - 8°C).
Żommu fi friġġ waqt il- ħażna u l- ġarr (2°C – 8°C).
Keep the pre-filled syringe in the outer carton in order to protect from light.
Żomm is- siringa mimlija għal- lest fil- kartuna ta ’ barra sabiex tilqa ’ mid- dawl.
14 For the purpose of ambulatory use, the patient may remove Binocrit from the refrigerator and store it not above 25°C for one single period of up to 3 days.
Għall- iskop ta ’ użu ambulatorju, il- pazjent jista ’ jneħħi Binocrit minn ġol- friġġ u jaħżnu mhux ’ il fuq minn 25°C għal perijodu wieħed sa 3 ijiem.
6.5 Nature and contents of container
6. 5 In- natura tal- kontenitur u ta ’ dak li hemm ġo fih
Pre-filled syringes (glass type I) with plunger (Teflon-faced rubber) sealed in a blister.
Siringi mimlijin għal- lest (ħġieġ ta ’ tip I) bi planġer (lastku miksi bit- Teflon) issiġillati f’ folja.
The syringes contain 0.5 ml (1000 IU) of solution.
Is- siringi fihom 0. 5 ml (1000 IU) ta ’ soluzzjoni.
Syringes are embossed with graduation rings and the filling volume is indicated by a stick-on label in order to enable partial use if required.
Is- siringi huma mnaqqxa bi ċrieki ggradati u l- volum tal- mili hu indikat permezz ta ’ tikketta li teħel biex tippermetti l- użu parzjali jekk ikun meħtieġ.
Pack of 1 or 6 syringes.
Pakkett ta ’ 1 jew 6 siringi.
Not all pack sizes may be marketed.
Jista ’ jkun li mhux il- pakketti tad- daqsijiet kollha jkunu għal skop kummerċjali.
6.6 Special precautions for disposal and other handling
6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema u għal immaniġġar ieħor
Binocrit must not be used
Binocrit m’ għandux jintuża
- if the solution is cloudy or there are particles in it.
- jekk is- soluzzjoni tkun imdardra jew ikun hemm frak ġo fiha.
- if the seal is broken.
- jekk is- siġill ikun miksur.
- if the solution has been accidentally frozen.
- jekk is- soluzzjoni tkun ġiet iffriżata bi żball.
The pre-filled syringes are ready to use (see section 4.2 – Method of administration).
Is- siringa mimlijin għal- lest huma lesti biex jintużaw (ara sezzjoni 4. 2 – Metodu ta ’ kif għandu jingħata).
After injection of the necessary amount of the solution from the pre-filled syringe, discard any remaining contents.
Wara l- injezzjoni ta ’ l- ammont neċessarju tas- soluzzjoni mis- siringa mimlija għal- lest, armi l- bqija tal- kontenut.
The pre-filled syringe should not be shaken.
Is- siringa mimlija għal- lest m’ għandhiex tiċċaqlaq (titħawwad).
Any unused product or waste material should be disposed of in accordance with local requirements.
Kull fdal tal- prodott li ma jkunx intuża jew skart li jibqa wara l- użu tal- prodott għandu jintrema kif jitolbu l- liġijiet lokali.
MARKETING AUTHORISATION HOLDER
ID- DETENTUR TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
10 A-6250 Kundl Austria
10 A- 6250 Kundl Awstrija
DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION
DATA TA ’ L- EWWEL AWTORIZZAZZJONI/ TIĠDID TA ’ L- AWTORIZZAZZJONI
28 August 2007
28 ta ’ Awwissu, 2007
DATE OF REVISION OF THE TEXT
DATA TA ’ META ĠIET RIVEDUTA L- KITBA
Binocrit 2000 IU/ 1 ml solution for injection in a pre-filled syringe
Binocrit 2000 IU/ 1 ml soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest
Each ml of solution contains 2000 IU of epoetin alfa* corresponding to 16.8 micrograms per ml 1 pre-filled syringe of 1 ml contains 2000 international units (IU) corresponding to 16.8 micrograms epoetin alfa
Kull ml ta ’ soluzzjoni fih 2000 IU ta ’ epoetin alfa * li jikkorrispondu għal 16. 8 mikrogrammi f’ kull ml Siringa mimlija għal- lest ta ’ 1 ml fiha 2000 unità internazzjonali (IU) li jikkorrispondu għal 16. 8 mikrogrammi ta ’ epoetin alfa
4.2 Posology and method of administration
17 4. 2 Pożoloġija u metodu ta ’ kif għandu jingħata
16 Posology
Pożoloġija
Paediatric haemodialysis patients:
18 Pazjenti pedjatriċi fuq l- emodijalisi:
50 IU/ kg 3 times per week by the intravenous route.
Fażi ta ’ korrezzjoni 50 IU/ kg 3 darbiet fil- ġimgħa minn ġol- vina.
Due to intra-patient variability, occasional individual haemoglobin values for a patient above and below the desired haemoglobin level may be observed.
19 Minħabba l- varjabilità bejn il- pazjenti, okkażjonalment jistgħu jkunu osservati figuri ta ’ l- emoglobina aktar għoljin jew aktar baxxi mil- livell mixtieq għal pazjent.
18 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 ’ iktar minn 12 g/ dl (7. 5 mmol/ l) għandu jkun evitat; gwida għal aġġustament adattat tad- doża għal meta jkunu osservati figuri ta ’ l- emoglobina li jaqbżu 12 g/ dl (7. 5 mmol/ l), huma deskritti hawn taħt.
The recommended dosing regimen is described in the following diagram:
20 Il- kors ta ’ dożaġġ rakkomandat huwa deskritt fid- dijagramma li ġejja:
19 150 IU/ kg 3x/ week or 450 IU/ kg once weekly
150 IU/ kg 3x/ ġimgħa jew 450 IU/ kg darba fil- ġimgħa
Treatment of adult patients scheduled for major elective orthopaedic surgery:
21 Kura ta ’ pazjenti adulti skedati għal operazzjoni ortopedika elettiva maġġuri:
20 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 patients with chronic renal failure, maintenance haemoglobin concentration should not exceed the upper limit of the target haemoglobin concentration recommended in section 4.2.
23 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.
22 (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.
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).
24 fatali kienet ogħla f’ pazjenti li kienu qed jirċievu epoetin alfa milli f’ dawk li kienu qed jirċievu l - plaċebo (ara sezzjoni 5. 1).
23 Patients scheduled for major elective orthopaedic surgery
Pazjenti skedati għal operazzjoni ortopedika elettiva maġġuri
4.5 Interaction with other medicinal products and other forms of interaction
25 4. 5 Prodotti mediċinali oħra li ma jaqblux ma ’ dan il- prodott u affarijiet oħra li jistgħu jibdlu l- effett farmaċewtiku tal- prodott
Adult and paediatric haemodialysis patients, adult peritoneal dialysis patients and adult patients with renal insufficiency not yet undergoing dialysis
26 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
25 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.
The apparent molecular weight of erythropoietin is 32,000 to 40,000 dalton.
27 Il- piż molekulari apparenti ta ’ eritropoetin hu minn 32, 000 sa 40, 000 dalton.
26 721 cancer patients receiving non-platinum chemotherapy were included in three placebo-controlled studies, 389 patients with haematological malignancies (221 multiple myeloma, 144 non-Hodgkin's lymphoma, and 24 other haematological malignancies) and 332 with solid tumours (172 breast, 64 gynaecological, 23 lung, 22 prostate, 21 gastro-intestinal, and 30 other tumour types).
721 pazjent morda bil- kanċer li kienu qegħdin jirċievu kimoterapija mhux bil- platinu kienu inklużi fi tliet studji kkontrollati bil- plaċebo, 389 pazjent b’ tumuri ematoloġiċi malinni (221 majeloma multipla, 144 limfoma mhux ta ’ Hodgkin, u 24 tumur ematoloġiku malinn ieħor) u 332 b’ tumuri solidi (172 tas - sider, 64 ġinekoloġiċi, 23 tal- pulmun, 22 tal- prostata, 21 gastro- intestinali, 30 tip ieħor ta ’ tumuri).
A systematic review has also been performed involving more than 9000 cancer patients participating in 57 clinical trials.
28 Saret ukoll evalwazzjoni sistematika li kienet tinvolvi iktar minn 9000 pazjent bil- kanċer li kienu qed jipparteċipaw f’ 57 prova klinika.
28 For the purpose of ambulatory use, the patient may remove Binocrit from the refrigerator and store it not above 25°C for one single period of up to 3 days.
Għall- iskop ta ’ użu ambulatorju, il- pazjent jista ’ jneħħi Binocrit minn ġol- friġġ u jaħżnu mhux ’ il fuq minn 25°C għal perijodu wieħed sa 3 ijiem.
The syringes contain 1 ml (2000 IU) of solution.
Is- siringi fihom 1 ml (2000 IU) ta ’ soluzzjoni.
Binocrit 3000 IU/ 0.3 ml solution for injection in a pre-filled syringe
Binocrit 3000 IU/ 0. 3 ml soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest
Each ml of solution contains 10 000 IU of epoetin alfa* corresponding to 84.0 micrograms per ml 1 pre-filled syringe of 0.3 ml contains 3000 international units (IU) corresponding to 25.2 micrograms epoetin alfa
Kull ml ta ’ soluzzjoni fih 10, 000 IU ta ’ epoetin alfa * li jikkorrispondu għal 84. 0 mikrogramma f’ kull ml Siring mimlija għal- lest ta ’ 0. 3 ml fiha 3000 unità internazzjonali (IU) li jikkorrispondu għal 25. 2 mikrogramma ta ’ epoetin alfa
4.2 Posology and method of administration
32 4. 2 Pożoloġija u metodu ta ’ kif għandu jingħata
30 Posology
Pożoloġija
Paediatric haemodialysis patients:
33 Pazjenti pedjatriċi fuq l- emodijalisi:
Due to intra-patient variability, occasional individual haemoglobin values for a patient above and below the desired haemoglobin level may be observed.
34 Minħabba l- varjabilità bejn il- pazjenti, okkażjonalment jistgħu jkunu osservati figuri ta ’ l- emoglobina aktar għoljin jew aktar baxxi mil- livell mixtieq għal pazjent.
32 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 ’ iktar minn 12 g/ dl (7. 5 mmol/ l) għandu jkun evitat; gwida għal aġġustament adattat tad- doża għal meta jkunu osservati figuri ta ’ l- emoglobina li jaqbżu 12 g/ dl (7. 5 mmol/ l), huma deskritti hawn taħt.
The recommended dosing regimen is described in the following diagram:
35 Il- kors ta ’ dożaġġ rakkomandat huwa deskritt fid- dijagramma li ġejja:
33 150 IU/ kg 3x/ week or 450 IU/ kg once weekly
150 IU/ kg 3x/ ġimgħa jew 450 IU/ kg darba fil- ġimgħa
Treatment of adult patients scheduled for major elective orthopaedic surgery:
36 Kura ta ’ pazjenti adulti skedati għal operazzjoni ortopedika elettiva maġġuri:
34 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 patients with chronic renal failure, maintenance haemoglobin concentration should not exceed the upper limit of the target haemoglobin concentration recommended in section 4.2.
38 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.
36 (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.
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).
39 fatali kienet ogħla f’ pazjenti li kienu qed jirċievu epoetin alfa milli f’ dawk li kienu qed jirċievu l - plaċebo (ara sezzjoni 5. 1).
37 Patients scheduled for major elective orthopaedic surgery
Pazjenti skedati għal operazzjoni ortopedika elettiva maġġuri
4.5 Interaction with other medicinal products and other forms of interaction
40 4. 5 Prodotti mediċinali oħra li ma jaqblux ma ’ dan il- prodott u affarijiet oħra li jistgħu jibdlu l- effett farmaċewtiku tal- prodott
Adult and paediatric haemodialysis patients, adult peritoneal dialysis patients and adult patients with renal insufficiency not yet undergoing dialysis
41 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
39 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.
The apparent molecular weight of erythropoietin is 32,000 to 40,000 dalton.
42 Il- piż molekulari apparenti ta ’ eritropoetin hu minn 32, 000 sa 40, 000 dalton.
40 721 cancer patients receiving non-platinum chemotherapy were included in three placebo-controlled studies, 389 patients with haematological malignancies (221 multiple myeloma, 144 non-Hodgkin's lymphoma, and 24 other haematological malignancies) and 332 with solid tumours (172 breast, 64 gynaecological, 23 lung, 22 prostate, 21 gastro-intestinal, and 30 other tumour types).
721 pazjent morda bil- kanċer li kienu qegħdin jirċievu kimoterapija mhux bil- platinu kienu inklużi fi tliet studji kkontrollati bil- plaċebo, 389 pazjent b’ tumuri ematoloġiċi malinni (221 majeloma multipla, 144 limfoma mhux ta ’ Hodgkin, u 24 tumur ematoloġiku malinn ieħor) u 332 b’ tumuri solidi (172 tas - sider, 64 ġinekoloġiċi, 23 tal- pulmun, 22 tal- prostata, 21 gastro- intestinali, 30 tip ieħor ta ’ tumuri).
A systematic review has also been performed involving more than 9000 cancer patients participating in 57 clinical trials.
43 Saret ukoll evalwazzjoni sistematika li kienet tinvolvi iktar minn 9000 pazjent bil- kanċer li kienu qed jipparteċipaw f’ 57 prova klinika.
42 For the purpose of ambulatory use, the patient may remove Binocrit from the refrigerator and store it not above 25°C for one single period of up to 3 days.
Għall- iskop ta ’ użu ambulatorju, il- pazjent jista ’ jneħħi Binocrit minn ġol- friġġ u jaħżnu mhux ’ il fuq minn 25°C għal perijodu wieħed sa 3 ijiem.
The syringes contain 0.3 ml (3000 IU) of solution.
Is- siringi fihom 0. 3 ml (3000 IU) ta ’ soluzzjoni.
Binocrit 4000 IU/ 0.4 ml solution for injection in a pre-filled syringe
Binocrit 4000 IU/ 0. 4 ml soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest
Each ml of solution contains 10 000 IU of epoetin alfa* corresponding to 84.0 micrograms per ml 1 pre-filled syringe of 0.4 ml contains 4000 international units (IU) corresponding to 33.6 micrograms epoetin alfa
Kull ml ta ’ soluzzjoni fih 10, 000 IU ta ’ epoetin alfa * li jikkorrispondu għal 84. 0 mikrogramma f’ kull ml Siringa mimlija għal- lest ta ’ 0. 4 ml fiha 4000 unità internazzjonali (IU) li jikkorrispondu għal 33. 6 mikrogramma ta ’ epoetin alfa
4.2 Posology and method of administration
47 4. 2 Pożoloġija u metodu ta ’ kif għandu jingħata
44 Posology
Pożoloġija
Paediatric haemodialysis patients:
48 Pazjenti pedjatriċi fuq l- emodijalisi:
Due to intra-patient variability, occasional individual haemoglobin values for a patient above and below the desired haemoglobin level may be observed.
49 Minħabba l- varjabilità bejn il- pazjenti, okkażjonalment jistgħu jkunu osservati figuri ta ’ l- emoglobina aktar għoljin jew aktar baxxi mil- livell mixtieq għal pazjent.
46 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 ’ iktar minn 12 g/ dl (7. 5 mmol/ l) għandu jkun evitat; gwida għal aġġustament adattat tad- doża għal meta jkunu osservati figuri ta ’ l- emoglobina li jaqbżu 12 g/ dl (7. 5 mmol/ l), huma deskritti hawn taħt.
The recommended dosing regimen is described in the following diagram:
50 Il- kors ta ’ dożaġġ rakkomandat huwa deskritt fid- dijagramma li ġejja:
47 150 IU/ kg 3x/ week or 450 IU/ kg once weekly
150 IU/ kg 3x/ ġimgħa jew 450 IU/ kg darba fil- ġimgħa
Treatment of adult patients scheduled for major elective orthopaedic surgery:
51 Kura ta ’ pazjenti adulti skedati għal operazzjoni ortopedika elettiva maġġuri:
48 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 patients with chronic renal failure, maintenance haemoglobin concentration should not exceed the upper limit of the target haemoglobin concentration recommended in section 4.2.
53 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.
50 (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.
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).
54 fatali kienet ogħla f’ pazjenti li kienu qed jirċievu epoetin alfa milli f’ dawk li kienu qed jirċievu l - plaċebo (ara sezzjoni 5. 1).
51 Patients scheduled for major elective orthopaedic surgery
Pazjenti skedati għal operazzjoni ortopedika elettiva maġġuri
4.5 Interaction with other medicinal products and other forms of interaction
55 4. 5 Prodotti mediċinali oħra li ma jaqblux ma ’ dan il- prodott u affarijiet oħra li jistgħu jibdlu l- effett farmaċewtiku tal- prodott
Adult and paediatric haemodialysis patients, adult peritoneal dialysis patients and adult patients with renal insufficiency not yet undergoing dialysis
56 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
53 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.
The apparent molecular weight of erythropoietin is 32,000 to 40,000 dalton.
57 Il- piż molekulari apparenti ta ’ eritropoetin hu minn 32, 000 sa 40, 000 dalton.
54 721 cancer patients receiving non-platinum chemotherapy were included in three placebo-controlled studies, 389 patients with haematological malignancies (221 multiple myeloma, 144 non-Hodgkin's lymphoma, and 24 other haematological malignancies) and 332 with solid tumours (172 breast, 64 gynaecological, 23 lung, 22 prostate, 21 gastro-intestinal, and 30 other tumour types).
721 pazjent morda bil- kanċer li kienu qegħdin jirċievu kimoterapija mhux bil- platinu kienu inklużi fi tliet studji kkontrollati bil- plaċebo, 389 pazjent b’ tumuri ematoloġiċi malinni (221 majeloma multipla, 144 limfoma mhux ta ’ Hodgkin, u 24 tumur ematoloġiku malinn ieħor) u 332 b’ tumuri solidi (172 tas - sider, 64 ġinekoloġiċi, 23 tal- pulmun, 22 tal- prostata, 21 gastro- intestinali, 30 tip ieħor ta ’ tumuri).
A systematic review has also been performed involving more than 9000 cancer patients participating in 57 clinical trials.
58 Saret ukoll evalwazzjoni sistematika li kienet tinvolvi iktar minn 9000 pazjent bil- kanċer li kienu qed jipparteċipaw f’ 57 prova klinika.
56 For the purpose of ambulatory use, the patient may remove Binocrit from the refrigerator and store it not above 25°C for one single period of up to 3 days.
Għall- iskop ta ’ użu ambulatorju, il- pazjent jista ’ jneħħi Binocrit minn ġol- friġġ u jaħżnu mhux ’ il fuq minn 25°C għal perijodu wieħed sa 3 ijiem.
The syringes contain 0.4 ml (4000 IU) of solution.
Is- siringi fihom 0. 4 ml (4000 IU) ta ’ soluzzjoni.
Binocrit 5000 IU/ 0.5 ml solution for injection in a pre-filled syringe
Binocrit 5000 IU/ 0. 5 ml soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest
Each ml of solution contains 10 000 IU of epoetin alfa* corresponding to 84.0 micrograms per ml 1 pre-filled syringe of 0.5 ml contains 5000 international units (IU) corresponding to 42.0 micrograms epoetin alfa
Kull ml ta ’ soluzzjoni fih 10, 000 IU ta ’ epoetin alfa * li jikkorrispondu għal 84. 0 mikrogramma f’ kull ml Siringa mimlija għal- lest ta ’ 0. 5 ml fiha 5000 unità internazzjonali (IU) li jikkorrispondu għal 42. 0 mikrogramma ta ’ epoetin alfa
4.2 Posology and method of administration
62 4. 2 Pożoloġija u metodu ta ’ kif għandu jingħata
58 Posology
Pożoloġija
Paediatric haemodialysis patients:
63 Pazjenti pedjatriċi fuq l- emodijalisi:
Due to intra-patient variability, occasional individual haemoglobin values for a patient above and below the desired haemoglobin level may be observed.
64 Minħabba l- varjabilità bejn il- pazjenti, okkażjonalment jistgħu jkunu osservati figuri ta ’ l- emoglobina aktar għoljin jew aktar baxxi mil- livell mixtieq għal pazjent.
60 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 ’ iktar minn 12 g/ dl (7. 5 mmol/ l) għandu jkun evitat; gwida għal aġġustament adattat tad- doża għal meta jkunu osservati figuri ta ’ l- emoglobina li jaqbżu 12 g/ dl (7. 5 mmol/ l), huma deskritti hawn taħt.
The recommended dosing regimen is described in the following diagram:
65 Il- kors ta ’ dożaġġ rakkomandat huwa deskritt fid- dijagramma li ġejja:
61 150 IU/ kg 3x/ week or 450 IU/ kg once weekly
150 IU/ kg 3x/ ġimgħa jew 450 IU/ kg darba fil- ġimgħa
Treatment of adult patients scheduled for major elective orthopaedic surgery:
66 Kura ta ’ pazjenti adulti skedati għal operazzjoni ortopedika elettiva maġġuri:
62 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 patients with chronic renal failure, maintenance haemoglobin concentration should not exceed the upper limit of the target haemoglobin concentration recommended in section 4.2.
68 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.
64 (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.
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).
69 fatali kienet ogħla f’ pazjenti li kienu qed jirċievu epoetin alfa milli f’ dawk li kienu qed jirċievu l - plaċebo (ara sezzjoni 5. 1).
65 Patients scheduled for major elective orthopaedic surgery
Pazjenti skedati għal operazzjoni ortopedika elettiva maġġuri
4.5 Interaction with other medicinal products and other forms of interaction
70 4. 5 Prodotti mediċinali oħra li ma jaqblux ma ’ dan il- prodott u affarijiet oħra li jistgħu jibdlu l- effett farmaċewtiku tal- prodott
Adult and paediatric haemodialysis patients, adult peritoneal dialysis patients and adult patients with renal insufficiency not yet undergoing dialysis
71 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
67 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.
The apparent molecular weight of erythropoietin is 32,000 to 40,000 dalton.
72 Il- piż molekulari apparenti ta ’ eritropoetin hu minn 32, 000 sa 40, 000 dalton.
68 721 cancer patients receiving non-platinum chemotherapy were included in three placebo-controlled studies, 389 patients with haematological malignancies (221 multiple myeloma, 144 non-Hodgkin's lymphoma, and 24 other haematological malignancies) and 332 with solid tumours (172 breast, 64 gynaecological, 23 lung, 22 prostate, 21 gastro-intestinal, and 30 other tumour types).
721 pazjent morda bil- kanċer li kienu qegħdin jirċievu kimoterapija mhux bil- platinu kienu inklużi fi tliet studji kkontrollati bil- plaċebo, 389 pazjent b’ tumuri ematoloġiċi malinni (221 majeloma multipla, 144 limfoma mhux ta ’ Hodgkin, u 24 tumur ematoloġiku malinn ieħor) u 332 b’ tumuri solidi (172 tas - sider, 64 ġinekoloġiċi, 23 tal- pulmun, 22 tal- prostata, 21 gastro- intestinali, 30 tip ieħor ta ’ tumuri).
A systematic review has also been performed involving more than 9000 cancer patients participating in 57 clinical trials.
73 Saret ukoll evalwazzjoni sistematika li kienet tinvolvi iktar minn 9000 pazjent bil- kanċer li kienu qed jipparteċipaw f’ 57 prova klinika.
70 For the purpose of ambulatory use, the patient may remove Binocrit from the refrigerator and store it not above 25°C for one single period of up to 3 days.
Għall- iskop ta ’ użu ambulatorju, il- pazjent jista ’ jneħħi Binocrit minn ġol- friġġ u jaħżnu mhux ’ il fuq minn 25°C għal perijodu wieħed sa 3 ijiem.
The syringes contain 0.5 ml (5000 IU) of solution.
Is- siringi fihom 0. 5 ml (5000 IU) ta ’ soluzzjoni.
Binocrit 6000 IU/ 0.6 ml solution for injection in a pre-filled syringe
Binocrit 6000 IU/ 0. 6 ml soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest
Each ml of solution contains 10 000 IU of epoetin alfa* corresponding to 84.0 micrograms per ml 1 pre-filled syringe of 0.6 ml contains 6000 international units (IU) corresponding to 50.4 micrograms epoetin alfa
Kull ml ta ’ soluzzjoni fih 10, 000 IU ta ’ epoetin alfa * li jikkorrispondu għal 84. 0 mikrogramma f’ kull ml Siringa mimlija għal- lest ta ’ 0. 6 ml fiha 6000 unità internazzjonali (IU) li jikkorrispondu għal 50. 4 mikrogramma ta ’ epoetin alfa
4.2 Posology and method of administration
77 4. 2 Pożoloġija u metodu ta ’ kif għandu jingħata
72 Posology
Pożoloġija
Paediatric haemodialysis patients:
78 Pazjenti pedjatriċi fuq l- emodijalisi:
Due to intra-patient variability, occasional individual haemoglobin values for a patient above and below the desired haemoglobin level may be observed.
79 Minħabba l- varjabilità bejn il- pazjenti, okkażjonalment jistgħu jkunu osservati figuri ta ’ l- emoglobina aktar għoljin jew aktar baxxi mil- livell mixtieq għal pazjent.
74 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 ’ iktar minn 12 g/ dl (7. 5 mmol/ l) għandu jkun evitat; gwida għal aġġustament adattat tad- doża għal meta jkunu osservati figuri ta ’ l- emoglobina li jaqbżu 12 g/ dl (7. 5 mmol/ l), huma deskritti hawn taħt.
The recommended dosing regimen is described in the following diagram:
80 Il- kors ta ’ dożaġġ rakkomandat huwa deskritt fid- dijagramma li ġejja:
75 150 IU/ kg 3x/ week or 450 IU/ kg once weekly
150 IU/ kg 3x/ ġimgħa jew 450 IU/ kg darba fil- ġimgħa
Treatment of adult patients scheduled for major elective orthopaedic surgery:
81 Kura ta ’ pazjenti adulti skedati għal operazzjoni ortopedika elettiva maġġuri:
76 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 patients with chronic renal failure, maintenance haemoglobin concentration should not exceed the upper limit of the target haemoglobin concentration recommended in section 4.2.
83 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.
78 (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.
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).
84 fatali kienet ogħla f’ pazjenti li kienu qed jirċievu epoetin alfa milli f’ dawk li kienu qed jirċievu l - plaċebo (ara sezzjoni 5. 1).
79 Patients scheduled for major elective orthopaedic surgery
Pazjenti skedati għal operazzjoni ortopedika elettiva maġġuri
4.5 Interaction with other medicinal products and other forms of interaction
85 4. 5 Prodotti mediċinali oħra li ma jaqblux ma ’ dan il- prodott u affarijiet oħra li jistgħu jibdlu l- effett farmaċewtiku tal- prodott
Adult and paediatric haemodialysis patients, adult peritoneal dialysis patients and adult patients with renal insufficiency not yet undergoing dialysis
86 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
81 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.
The apparent molecular weight of erythropoietin is 32,000 to 40,000 dalton.
87 Il- piż molekulari apparenti ta ’ eritropoetin hu minn 32, 000 sa 40, 000 dalton.
82 721 cancer patients receiving non-platinum chemotherapy were included in three placebo-controlled studies, 389 patients with haematological malignancies (221 multiple myeloma, 144 non-Hodgkin's lymphoma, and 24 other haematological malignancies) and 332 with solid tumours (172 breast, 64 gynaecological, 23 lung, 22 prostate, 21 gastro-intestinal, and 30 other tumour types).
721 pazjent morda bil- kanċer li kienu qegħdin jirċievu kimoterapija mhux bil- platinu kienu inklużi fi tliet studji kkontrollati bil- plaċebo, 389 pazjent b’ tumuri ematoloġiċi malinni (221 majeloma multipla, 144 limfoma mhux ta ’ Hodgkin, u 24 tumur ematoloġiku malinn ieħor) u 332 b’ tumuri solidi (172 tas - sider, 64 ġinekoloġiċi, 23 tal- pulmun, 22 tal- prostata, 21 gastro- intestinali, 30 tip ieħor ta ’ tumuri).
A systematic review has also been performed involving more than 9000 cancer patients participating in 57 clinical trials.
88 Saret ukoll evalwazzjoni sistematika li kienet tinvolvi iktar minn 9000 pazjent bil- kanċer li kienu qed jipparteċipaw f’ 57 prova klinika.
84 For the purpose of ambulatory use, the patient may remove Binocrit from the refrigerator and store it not above 25°C for one single period of up to 3 days.
Għall- iskop ta ’ użu ambulatorju, il- pazjent jista ’ jneħħi Binocrit minn ġol- friġġ u jaħżnu mhux ’ il fuq minn 25°C għal perijodu wieħed sa 3 ijiem.
The syringes contain 0.6 ml (6000 IU) of solution.
Is- siringi fihom 0. 6 ml (6000 IU) ta ’ soluzzjoni.
Binocrit 7000 IU/ 0.7 ml solution for injection in a pre-filled syringe
Binocrit 7000 IU/ 0. 7 ml soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest
Each ml of solution contains 10 000 IU of epoetin alfa* corresponding to 84.0 micrograms per ml 1 pre-filled syringe of 0.7 ml contains 7000 international units (IU) corresponding to 58.8 micrograms epoetin alfa
Kull ml ta ’ soluzzjoni fih 10, 000 IU ta ’ epoetin alfa * li jikkorrispondu għal 84. 0 mikrogramma f’ kull ml Siringa mimlija għal- lest ta ’ 0. 7 ml fiha 7000 unità internazzjonali (IU) li jikkorrispondu għal 58. 8 mikrogramma ta ’ epoetin alfa
4.2 Posology and method of administration
92 4. 2 Pożoloġija u metodu ta ’ kif għandu jingħata
86 Posology
Pożoloġija
Paediatric haemodialysis patients:
93 Pazjenti pedjatriċi fuq l- emodijalisi: