qanastek/EMEA-V3 huggingface dataset:
Epoetin alfa HEXAL can be used to reduce exposure to allogeneic blood transfusions in adult non-iron deficient patients prior to major elective orthopaedic surgery, having a high perceived risk for transfusion complications.
Epoetin alfa HEXAL jista ’ jintuża sabiex inaqqas l- esponiment għal trasfużjonijiet tad- demm alloġeneiċi f’ pazjenti adulti mhux nieqsa mill- ħadid qabel operazzjoni ortopedika elettiva maġġuri, li jkollhom riskju perċepit għoli ta ’ kumplikazzjonijiet mit- trasfużjoni.
Treatment with Epoetin alfa HEXAL has to be initiated under the supervision of physicians experienced in the management of patients with the above indications.
Il- kura b’ Epoetin alfa HEXAL għandha tinbeda taħt is- superviżjoni ta ’ tobba b’ esperjenza fl - immaniġġar ta ’ pazjenti bis- sintomi msemmija hawn fuq.
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.
Sintomi ta ’ anemija u l- konsegwenzi tagħha jistgħu jvarjaw skond l- età, is- sess, u l- gravità totali tal - marda; hemm bżonn ta ’ evalwazzjoni ta ’ tabib tal- kors kliniku u tal- kundizzjoni tal- pazjent individwali.
Epoetin alfa HEXAL should be administered intravenously in order to increase haemoglobin to not greater than 12 g/ dl (7.5 mmol/ l).
Epoetin alfa HEXAL għandu jingħata minn ġol- vina sabiex iżid l- emoglobina għal mhux iktar minn 12 g/ dl (7. 5 mmol/ l).
If it occurs, appropriate dose adjustments should be made as provided.
Jekk din isseħħ, għandhom isiru aġġustamenti adattati tad - doża kif meħtieġ.
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 ta ’ l - emoglobina għandha tkun indirizzata permezz ta ’ l- immaniġġjar tad- doża, b’ konsiderazzjoni għall - mira ta ’ medda ta ’ l- emoglobina ta ’ 10 g/ dl (6. 2 mmol/ l) sa 12 g/ dl (7. 5 mmol/ l).
Patients should be monitored closely to ensure that the lowest approved dose of Epoetin alfa is used to provide adequate control of anaemia and of the symptoms of anaemia.
Il- pazjenti għandhom ikunu mmonitorjati mill- qrib biex ikun żgurat li tintuża l- inqas doża approvata ta ’ Epoetin alfa biex tipprovdi kontroll adegwat ta ’ anemija u tas- sintomi ta ’ l- anemija.
Iron status should be evaluated prior to and during treatment and iron supplementation administered if necessary.
L- istatus tal- livell tal- ħadid għandu jiġi evalwat qabel u matul il- kura u jingħata suppliment ta ’ ħadid jekk ikun meħtieġ.
Non response to epoetin alfa therapy may have the following causes: 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.
In- nuqqas ta ’ respons għal terapija b’ epoetin alfa jista ’ jkollu l- kawżi li ġejjin: defiċjenza ta ’ ħadid, folate jew vitamina B12; avvelenament bl- aluminju; infezzjonijiet li jitfaċċaw minn żmien għal ieħor; episodji infjammatorji jew trawmatiċi; telf ta ’ demm li ma jidhirx; emodijalisi u fibrożi tal- mudullun ta ’ kwalunkwe oriġini.
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 ta ’ l- emoglobina għandha tkun indirizzata permezz ta ’ l- immaniġġjar tad- doża, b’ konsiderazzjoni għall- mira tal- medda ta ’ l -
A sustained haemoglobin level of greater than 12 g/ dl (7.5 mmol/ l) should be
4 emoglobina ta ’ 10 g/ dl (6. 2 mmol/ l) sa 12 g/ dl (7. 5 mmol/ l).
4 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.
Epoetin alfa HEXAL should be given by the intravenous route.
Epoetin alfa HEXAL għandu jingħata ġol- vini.
At the time of donating blood, Epoetin alfa HEXAL should be administered after the completion of the blood donation procedure.
Meta jingħata d- demm, Epoetin alfa HEXAL għandu jingħata wara li titlesta l- proċedura tal- għoti tad - demm.
Mildly anaemic patients (haematocrit of 33 - 39%) requiring predeposit of ≥ 4 units of blood should be treated with Epoetin alfa HEXAL at a dose of 600 IU/ kg body weight 2 times weekly for 3 weeks prior to surgery.
Pazjenti li għandhom anemija ħafifa (ematokrit ta ’ 33 - 39%) li jeħtieġu predepożitu ta ’ ≥ 4 unitajiet ta ’ demm, għandhom jiġu kkurati b’ Epoetin alfa HEXAL b’ doża ta ’ 600 IU għal kull kilogramm ta ’ piż tal- ġisem darbtejn fil- ġimgħa għal 3 ġimgħat qabel l- operazzjoni.
All patients being treated with Epoetin alfa HEXAL should receive adequate iron supplementation (e. g.
Il- pazjenti kollha li jkunu qed jiġu kkurati b’ Epoetin alfa HEXAL għandhom jirċievu supplimentazzjoni adegwata tal- ħadid (eż.
200 mg oral elemental iron daily) throughout the course of treatment.
200 mg - ħadid elementali orali kuljum) matul il- kors tal - kura.
Iron supplementation should be started as soon as possible, even several weeks prior to initiating the autologous predeposit, in order to achieve high iron stores prior to starting Epoetin alfa HEXAL therapy.
Is- supplimentazzjoni tal- ħadid għandha tinbeda kemm jista ’ jkun malajr, anki diversi ġimgħat qabel ma tibda l- predepożitu awtologu, sabiex ikollok ħażna kbira ta ’ qabel ma tibda t- terapija b’ Epoetin alfa HEXAL.
Epoetin alfa HEXAL is a sterile but unpreserved product and is for single use only.
Epoetin alfa HEXAL huwa prodott sterili iżda mhux ippreservat u jintuża darba biss.
In chronic renal failure patients Epoetin alfa HEXAL has not to be administered subcutaneously!
F’ pazjenti b’ insuffiċjenza renali kronika, Epoetin alfa HEXAL m’ għandux jingħata taħt il- ġilda!
Patients who develop Pure Red Cell Aplasia (PRCA) following treatment with any erythropoietin should not receive Epoetin alfa HEXAL or any other erythropoietin (see section 4.4 - Pure Red Cell Aplasia).
Pazjenti li jiżviluppaw Aplasja taċ- Ċelluli l- Ħomor tad- Demm Pura (PRCA) wara kura b’ xi eritropoetin, m’ għandhomx jingħataw Epoetin alfa HEXAL jew xi eritropoetin ieħor (ara sezzjoni 4. 4 – Aplasja taċ- Ċelluli l- Ħomor tad- Demm Pura).
7 4.4 Special warnings and precautions for use
7 f’ pazjenti b’ mard koronarju, mard ta ’ l- arterji periferali, mard tal- karotide jew mard ċerebrovaskulari sever, fosthom pazjenti b’ infart mijokardijaku riċenti jew inċident ċerebrovaskulari.
In all patients receiving epoetin alfa, blood pressure should be closely monitored and controlled as necessary.
Il- pressjoni tad- demm, fil- pazjenti kollha li jkunu qegħdin jirċievu epoetin alfa għandha tiġi mmonitorjata mill- qrib u kkontrollata kif meħtieġ.
Epoetin alfa should be used with caution in the presence of untreated, inadequately treated or poorly controllable hypertension.
Epoetin alfa għandu jintuża b’ attenzjoni fil - preżenza ta ’ pressjoni għolja mhux ikkurata, ikkurata b’ mod inadegwat jew li ma tantx tista ’ tiġi kkontrollata sewwa.
patients) is recommended for chronic renal failure patients whose serum ferritin levels are below 100 ng/ ml
pazjenti pedjatriċi) huwa rakkomandat għal pazjenti b’ insuffiċjenza kronika tal- kliewi kronika li l- livelli ta ’ ferritin fis- serum tagħhom huma taħt 100 ng/ ml sostituzzjoni orali tal- livell ta ’ ferritin ta ’ 200 - 300 mg Fe2+/ jum huwa rakkomandat għal
Pure Red Cell Aplasia (PRCA) Antibody-mediated PRCA has been very rarely reported after months to years of subcutaneous erythropoietin treatment.
Aplasja taċ- Ċelluli l- Ħomor tad- Demm Pura (PRCA) PRCA medjata mill- antikorpi ġiet irrappurtata b’ mod rari ħafna wara perjodu ta ’ minn xhur sa snin ta ’ kura b’ eritropoetin mogħti minn taħt il- ġilda.
If anti-erythropoietin, antibody-mediated PRCA is suspected, therapy with Epoetin alfa HEXAL should be discontinued immediately.
Jekk tkun issuspettata PRCA medjata b’ antikorpi kontra l- eritropoetin, it- terapija b’ Epoetin alfa HEXAL għandha titwaqqaf immedjatament.
Appropriate therapy such as blood transfusions may be given to patients when indicated.
Terapija xierqa bħal trasfużjonijiet tad- demm tista ’ tingħata lill - pazjenti meta indikat.
Immunogenicity data for subcutaneous use of Epoetin alfa HEXAL in patients at risk for antibody-induced PRCA, i. e. patients with renal anaemia, are not sufficient.
Informazzjoni dwar l- immunoġeniċità għall- użu minn taħt il- ġilda ta ’ Epoetin alfa HEXAL f’ pazjenti f’ riskju għal PRCA ikkawżata mill- antikorpi, i. e. pazjenti b’ anemija renali, mhix suffiċjenti.
8 Controlled clinical trials have not shown significant benefits attributable to the administration of epoetins when haemoglobin concentration is increased beyond the level necessary to control symptoms of anaemia and to avoid blood transfusion.
Provi kliniċi kkontrollati ma wrewx benefiċċji sinifikanti attribwibbli għall- għoti ta ’ epoetins meta l - konċentrazzjoni ta ’ l- emoglobina tiżdied aktar mil- livell meħtieġ biex tikkontrolla s- sintomi ta ’ l - anemija u biex tevita trasfużjoni tad- demm.
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 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.
9 Adult surgery patients in an autologous predonation programme
Pazjenti kirurġiċi adulti fi programm ta ’ predonazzjoni awtologa
- increased risk of death when administered to target a haemoglobin of 12 g/ dl (7.5 mmol/ l) in
- żieda fir- riskju ta ’ mewt meta jingħata biex ikun immirat livell ta ’ emoglobina ta ’ 12 g/ dl
10 4.6 Pregnancy and lactation
4. 6 Tqala u treddigħ
Epoetin alfa HEXAL has no influence on the ability to drive and use machines.
Epoetin alfa HEXAL m’ għandu l- ebda effett fuq il- ħila ta ’ sewqan u l- użu ta ’ magni.
Thrombotic/ vascular events, such as myocardial ischaemia, myocardial infarction, cerebrovascular accidents (cerebral haemorrhage and cerebral infarction), transient ischaemic attacks, deep vein thrombosis, arterial thrombosis, pulmonary emboli, aneurysms, retinal thrombosis, and clotting of an artificial kidney have been reported in patients receiving erythropoietic agents, including patients receiving epoetin alfa.
Episodji trombotiċi/ vaskulari, bħal iskemija mijokardijaka, infart mijokardijaku, inċidenti ċerebrovaskulari (emorraġija ċerebrali u infart ċerebrali), attakki iskemiċi temporanji, trombożi tal - vini profonda, trombożi arterjali, emboli pulmonari, anewriżmi, trombożi fir- retina, u tagħqid ta ’ demm f’ kilwa artifiċjali kienu rrappurtati f’ pazjenti li kienu qed jirċievu sustanzi eritropoetiċi, fosthom pazjenti li kienu qed jirċievu epoetin alfa.
Early shunt revision and
Jistgħu jseħħu trombożi fix- xant, speċjalment f’ pazjenti li jkollhom tendenza għal pressjoni baxxa jew li l- fistuli bejn l- arterji u l- vini tagħhom juru komplikazzjonijiet (eż. stenosijiet, anewriżmi, eċċ.).
11 thrombosis prophylaxis by administration of acetylsalicylic acid, for example, is recommended in these patients.
Reviżjoni bikrija tax- xant u profilassi tat- trombożi bl- għoti ta ’ acetylsalicylic acid, pereżempju, huwa rakkomandat f’ dawn il- pazjenti.
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.
Epoetin alfa HEXAL has the highest possible purity according to the present state of the art.
Epoetin alfa HEXAL għandu l- ogħla purità possibbli skond l- aktar teknoloġija avvanzata fil- preżent.
12 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.
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).
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 morbużi 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).
13 5.2 Pharmacokinetic properties
5. 2 Tagħrif farmakokinetiku
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 18 hours postdose.
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.
Long-term carcinogenicity studies have not been carried out.
Ma sarux studji fuq perjodu fit- tul dwar il- karċinoġeniċità.
14 6.2 Incompatibilities
6. 2 Inkompatibilitajiet
For the purpose of ambulatory use, the patient may remove Epoetin alfa HEXAL 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 Epoetin alfa HEXAL minn ġol- friġġ u jaħżnu mhux ’ il fuq minn 25°C għal perijodu wieħed sa 3 ijiem.
Epoetin alfa HEXAL must not be used
Epoetin alfa HEXAL m’ għandux jintuża
Hexal AG Industriestrasse 25 D-83607 Holzkirchen Germany
15 Industriestrasse 25 D- 83607 Holzkirchen Il- Ġermanja
Epoetin alfa HEXAL 2000 IU/ 1 ml solution for injection in a pre-filled syringe
Epoetin alfa HEXAL 2000 IU/ 1 ml soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest
17 Posology
Pożoloġija
If it occurs, appropriate dose adjustments should be made as provided.
Jekk din isseħħ, għandhom isiru aġġustamenti adattati fid- doża kif meħtieġ.
Due to intra-patient variability, occasional individual haemoglobin values for a patient above and below the desired haemoglobin level may be observed.
Minħabba l- varjabilità bejn il- pazjenti, okkażjonalment jistgħu jkunu osservati figuri ta ’ l - emoglobina aktar għoljin jew aktar baxxi mil- livell mixtieq għal pazjent.
A sustained haemoglobin level of greater than 12 g/ dl (7.5 mmol/ l) should be
Il- varjabilità ta ’ l- emoglobina għandha tkun indirizzata permezz ta ’ l- immaniġġjar tad- doża, b’ konsiderazzjoni għall- mira ta ’ medda ta ’ l - emoglobina ta ’ 10 g/ dl (6. 2 mmol/ l) sa 12 g/ dl (7. 5 mmol/ l).
19 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 fid- doża għal meta jkunu osservati figuri ta ’ l- emoglobina li jaqbżu 12 g/ dl (7. 5 mmol/ l), huma deskritti hawn taħt.
20 150 IU/ kg 3x/ week or 450 IU/ kg once weekly
150 IU/ kg 3x/ ġimgħa jew 450 IU/ kg darba fil- ġimgħa
21 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).
22 4.4 Special warnings and precautions for use
22 f’ pazjenti b’ mard koronarju, mard ta ’ l- arterji periferali, mard tal- karotide jew mard ċerebrovaskulari sever, fosthom pazjenti b’ infart mijokardijaku riċenti jew inċident ċerebrovaskulari.
23 Controlled clinical trials have not shown significant benefits attributable to the administration of epoetins when haemoglobin concentration is increased beyond the level necessary to control symptoms of anaemia and to avoid blood transfusion.
Provi kliniċi kkontrollati ma wrewx benefiċċji sinifikanti attribwibbli għall- għoti ta ’ epoetins meta l - konċentrazzjoni ta ’ l- emoglobina tiżdied aktar mil- livell meħtieġ biex tikkontrolla s- sintomi ta ’ l - anemija u biex tevita trasfużjoni tad- demm.
24 Adult surgery patients in an autologous predonation programme
Pazjenti kirurġiċi adulti fi programm ta ’ predonazzjoni awtologa
patients with metastatic breast cancer receiving chemotherapy when administered to target a haemoglobin of 12 - 14 g/ dl (7.5 – 8.7 mmol/ l),
4 xhur f’ pazjenti b’ kanċer metastatiku tas- sider li jkunu qed jirċievu kimoterapija meta jingħata biex ikun immirat ta ’ livell ta ’ emoglobina ta ’ 12 - 14 g/ dl (7. 5 – 8. 7 mmol/ l),
25 4.6 Pregnancy and lactation
4. 6 Tqala u treddigħ
26 thrombosis prophylaxis by administration of acetylsalicylic acid, for example, is recommended in these patients.
Reviżjoni bikrija tax- xant u profilassi tat- trombożi bl- għoti ta ’ acetylsalicylic acid, pereżempju, huwa rakkomandat f’ dawn il- pazjenti.
27 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.
28 5.2 Pharmacokinetic properties
5. 2 Tagħrif farmakokinetiku
29 6.2 Incompatibilities
6. 2 Inkompatibilitajiet
Hexal AG Industriestrasse 25 D-83607 Holzkirchen Germany
30 Industriestrasse 25 D- 83607 Holzkirchen Il- Ġermanja
Epoetin alfa HEXAL 3000 IU/ 0.3 ml solution for injection in a pre-filled syringe
Epoetin alfa HEXAL 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
Siring mimlija għal- lest ta ’ 0. 3 ml fiha 3000 unità internazzjonali (IU) li jikkorrispondu għal 25. 2 mikrogramma ta ’ epoetin alfa
32 Posology
Pożoloġija
33 Correction phase:
33 Pazjenti pedjatriċi fuq l- emodijalisi:
34 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 fid- doża għal meta jkunu osservati figuri ta ’ l- emoglobina li jaqbżu 12 g/ dl (7. 5 mmol/ l), huma deskritti hawn taħt.
35 150 IU/ kg 3x/ week or 450 IU/ kg once weekly
150 IU/ kg 3x/ ġimgħa jew 450 IU/ kg darba fil- ġimgħa
36 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).
37 4.4 Special warnings and precautions for use
37 f’ pazjenti b’ mard koronarju, mard ta ’ l- arterji periferali, mard tal- karotide jew mard ċerebrovaskulari sever, fosthom pazjenti b’ infart mijokardijaku riċenti jew inċident ċerebrovaskulari.
38 Controlled clinical trials have not shown significant benefits attributable to the administration of epoetins when haemoglobin concentration is increased beyond the level necessary to control symptoms of anaemia and to avoid blood transfusion.
Provi kliniċi kkontrollati ma wrewx benefiċċji sinifikanti attribwibbli għall- għoti ta ’ epoetins meta l - konċentrazzjoni ta ’ l- emoglobina tiżdied aktar mil- livell meħtieġ biex tikkontrolla s- sintomi ta ’ l - anemija u biex tevita trasfużjoni tad- demm.
39 Adult surgery patients in an autologous predonation programme
Pazjenti kirurġiċi adulti fi programm ta ’ predonazzjoni awtologa
radiation therapy when administered to target a haemoglobin of greater than 14 g/ dl (8.7 mmol/ l),
jirċievu terapija bir- radjazzjoni meta jingħata biex ikun immirat ta ’ livell ta ’ emoglobina ta ’ iktar minn 14 g/ dl (8. 7 mmol/ l),
40 4.6 Pregnancy and lactation
4. 6 Tqala u treddigħ
41 thrombosis prophylaxis by administration of acetylsalicylic acid, for example, is recommended in these patients.
Reviżjoni bikrija tax- xant u profilassi tat- trombożi bl- għoti ta ’ acetylsalicylic acid, pereżempju, huwa rakkomandat f’ dawn il- pazjenti.
42 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.
43 5.2 Pharmacokinetic properties
5. 2 Tagħrif farmakokinetiku
44 6.2 Incompatibilities
6. 2 Inkompatibilitajiet
Hexal AG Industriestrasse 25 D-83607 Holzkirchen Germany
45 Industriestrasse 25 D- 83607 Holzkirchen Il- Ġermanja
Epoetin alfa HEXAL 4000 IU/ 0.4 ml solution for injection in a pre-filled syringe
Epoetin alfa HEXAL 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
Siringa mimlija għal- lest ta ’ 0. 4 ml fiha 4000 unità internazzjonali (IU) li jikkorrispondu għal 33. 6 mikrogramma ta ’ epoetin alfa
47 Posology
Pożoloġija
48 Correction phase:
48 Pazjenti pedjatriċi fuq l- emodijalisi:
49 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 fid- doża għal meta jkunu osservati figuri ta ’ l- emoglobina li jaqbżu 12 g/ dl (7. 5 mmol/ l), huma deskritti hawn taħt.
50 150 IU/ kg 3x/ week or 450 IU/ kg once weekly
150 IU/ kg 3x/ ġimgħa jew 450 IU/ kg darba fil- ġimgħa
51 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).
52 4.4 Special warnings and precautions for use
52 f’ pazjenti b’ mard koronarju, mard ta ’ l- arterji periferali, mard tal- karotide jew mard ċerebrovaskulari sever, fosthom pazjenti b’ infart mijokardijaku riċenti jew inċident ċerebrovaskulari.
53 Controlled clinical trials have not shown significant benefits attributable to the administration of epoetins when haemoglobin concentration is increased beyond the level necessary to control symptoms of anaemia and to avoid blood transfusion.
Provi kliniċi kkontrollati ma wrewx benefiċċji sinifikanti attribwibbli għall- għoti ta ’ epoetins meta l - konċentrazzjoni ta ’ l- emoglobina tiżdied aktar mil- livell meħtieġ biex tikkontrolla s- sintomi ta ’ l - anemija u biex tevita trasfużjoni tad- demm.
54 Adult surgery patients in an autologous predonation programme
Pazjenti kirurġiċi adulti fi programm ta ’ predonazzjoni awtologa
55 4.6 Pregnancy and lactation
4. 6 Tqala u treddigħ
56 thrombosis prophylaxis by administration of acetylsalicylic acid, for example, is recommended in these patients.
Reviżjoni bikrija tax- xant u profilassi tat- trombożi bl- għoti ta ’ acetylsalicylic acid, pereżempju, huwa rakkomandat f’ dawn il- pazjenti.
57 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.
58 5.2 Pharmacokinetic properties
5. 2 Tagħrif farmakokinetiku
59 6.2 Incompatibilities
6. 2 Inkompatibilitajiet
Hexal AG Industriestrasse 25 D-83607 Holzkirchen Germany
60 Industriestrasse 25 D- 83607 Holzkirchen Il- Ġermanja
Epoetin alfa HEXAL 5000 IU/ 0.5 ml solution for injection in a pre-filled syringe
Epoetin alfa HEXAL 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
Siringa mimlija għal- lest ta ’ 0. 5 ml fiha 5000 unità internazzjonali (IU) li jikkorrispondu għal 42. 0 mikrogramma ta ’ epoetin alfa
62 Posology
Pożoloġija
63 Correction phase:
63 Pazjenti pedjatriċi fuq l- emodijalisi:
64 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 fid- doża għal meta jkunu osservati figuri ta ’ l- emoglobina li jaqbżu 12 g/ dl (7. 5 mmol/ l), huma deskritti hawn taħt.
65 150 IU/ kg 3x/ week or 450 IU/ kg once weekly
150 IU/ kg 3x/ ġimgħa jew 450 IU/ kg darba fil- ġimgħa
66 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).
67 4.4 Special warnings and precautions for use
67 f’ pazjenti b’ mard koronarju, mard ta ’ l- arterji periferali, mard tal- karotide jew mard ċerebrovaskulari sever, fosthom pazjenti b’ infart mijokardijaku riċenti jew inċident ċerebrovaskulari.
68 Controlled clinical trials have not shown significant benefits attributable to the administration of epoetins when haemoglobin concentration is increased beyond the level necessary to control symptoms of anaemia and to avoid blood transfusion.
Provi kliniċi kkontrollati ma wrewx benefiċċji sinifikanti attribwibbli għall- għoti ta ’ epoetins meta l - konċentrazzjoni ta ’ l- emoglobina tiżdied aktar mil- livell meħtieġ biex tikkontrolla s- sintomi ta ’ l - anemija u biex tevita trasfużjoni tad- demm.
69 Adult surgery patients in an autologous predonation programme
Pazjenti kirurġiċi adulti fi programm ta ’ predonazzjoni awtologa
70 4.6 Pregnancy and lactation
4. 6 Tqala u treddigħ
71 thrombosis prophylaxis by administration of acetylsalicylic acid, for example, is recommended in these patients.
Reviżjoni bikrija tax- xant u profilassi tat- trombożi bl- għoti ta ’ acetylsalicylic acid, pereżempju, huwa rakkomandat f’ dawn il- pazjenti.
72 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.
73 5.2 Pharmacokinetic properties
5. 2 Tagħrif farmakokinetiku
74 6.2 Incompatibilities
6. 2 Inkompatibilitajiet
Hexal AG Industriestrasse 25 D-83607 Holzkirchen Germany
75 Industriestrasse 25 D- 83607 Holzkirchen Il- Ġermanja
Epoetin alfa HEXAL 6000 IU/ 0.6 ml solution for injection in a pre-filled syringe
Epoetin alfa HEXAL 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
Siringa mimlija għal- lest ta ’ 0. 6 ml fiha 6000 unità internazzjonali (IU) li jikkorrispondu għal 50. 4 mikrogramma ta ’ epoetin alfa
77 Posology
Pożoloġija
78 Correction phase:
78 Pazjenti pedjatriċi fuq l- emodijalisi:
79 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 fid- doża għal meta jkunu osservati figuri ta ’ l- emoglobina li jaqbżu 12 g/ dl (7. 5 mmol/ l), huma deskritti hawn taħt.
80 150 IU/ kg 3x/ week or 450 IU/ kg once weekly
150 IU/ kg 3x/ ġimgħa jew 450 IU/ kg darba fil- ġimgħa
81 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).
82 4.4 Special warnings and precautions for use
82 f’ pazjenti b’ mard koronarju, mard ta ’ l- arterji periferali, mard tal- karotide jew mard ċerebrovaskulari sever, fosthom pazjenti b’ infart mijokardijaku riċenti jew inċident ċerebrovaskulari.
83 Controlled clinical trials have not shown significant benefits attributable to the administration of epoetins when haemoglobin concentration is increased beyond the level necessary to control symptoms of anaemia and to avoid blood transfusion.
Provi kliniċi kkontrollati ma wrewx benefiċċji sinifikanti attribwibbli għall- għoti ta ’ epoetins meta l - konċentrazzjoni ta ’ l- emoglobina tiżdied aktar mil- livell meħtieġ biex tikkontrolla s- sintomi ta ’ l - anemija u biex tevita trasfużjoni tad- demm.
84 Adult surgery patients in an autologous predonation programme
Pazjenti kirurġiċi adulti fi programm ta ’ predonazzjoni awtologa
85 4.6 Pregnancy and lactation
4. 6 Tqala u treddigħ
86 thrombosis prophylaxis by administration of acetylsalicylic acid, for example, is recommended in these patients.
Reviżjoni bikrija tax- xant u profilassi tat- trombożi bl- għoti ta ’ acetylsalicylic acid, pereżempju, huwa rakkomandat f’ dawn il- pazjenti.
87 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.
88 5.2 Pharmacokinetic properties
5. 2 Tagħrif farmakokinetiku
89 6.2 Incompatibilities
6. 2 Inkompatibilitajiet
Hexal AG Industriestrasse 25 D-83607 Holzkirchen Germany
90 Industriestrasse 25 D- 83607 Holzkirchen Il- Ġermanja
Epoetin alfa HEXAL 7000 IU/ 0.7 ml solution for injection in a pre-filled syringe
Epoetin alfa HEXAL 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
Siringa mimlija għal- lest ta ’ 0. 7 ml fiha 7000 unità internazzjonali (IU) li jikkorrispondu għal 58. 8 mikrogramma ta ’ epoetin alfa
92 Posology
Pożoloġija
93 Correction phase:
93 Pazjenti pedjatriċi fuq l- emodijalisi:
94 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 fid- doża għal meta jkunu osservati figuri ta ’ l- emoglobina li jaqbżu 12 g/ dl (7. 5 mmol/ l), huma deskritti hawn taħt.
95 150 IU/ kg 3x/ week or 450 IU/ kg once weekly
150 IU/ kg 3x/ ġimgħa jew 450 IU/ kg darba fil- ġimgħa
96 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).
97 4.4 Special warnings and precautions for use
97 f’ pazjenti b’ mard koronarju, mard ta ’ l- arterji periferali, mard tal- karotide jew mard ċerebrovaskulari sever, fosthom pazjenti b’ infart mijokardijaku riċenti jew inċident ċerebrovaskulari.
98 Controlled clinical trials have not shown significant benefits attributable to the administration of epoetins when haemoglobin concentration is increased beyond the level necessary to control symptoms of anaemia and to avoid blood transfusion.
Provi kliniċi kkontrollati ma wrewx benefiċċji sinifikanti attribwibbli għall- għoti ta ’ epoetins meta l - konċentrazzjoni ta ’ l- emoglobina tiżdied aktar mil- livell meħtieġ biex tikkontrolla s- sintomi ta ’ l - anemija u biex tevita trasfużjoni tad- demm.
99 Adult surgery patients in an autologous predonation programme
Pazjenti kirurġiċi adulti fi programm ta ’ predonazzjoni awtologa
100 4.6 Pregnancy and lactation
4. 6 Tqala u treddigħ
101 thrombosis prophylaxis by administration of acetylsalicylic acid, for example, is recommended in these patients.
Reviżjoni bikrija tax- xant u profilassi tat- trombożi bl- għoti ta ’ acetylsalicylic acid, pereżempju, huwa rakkomandat f’ dawn il- pazjenti.
102 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.
103 5.2 Pharmacokinetic properties
5. 2 Tagħrif farmakokinetiku
104 6.2 Incompatibilities
6. 2 Inkompatibilitajiet
Hexal AG Industriestrasse 25 D-83607 Holzkirchen Germany
105 Industriestrasse 25 D- 83607 Holzkirchen Il- Ġermanja
Epoetin alfa HEXAL 8000 IU/ 0.8 ml solution for injection in a pre-filled syringe
Epoetin alfa HEXAL 8000 IU/ 0. 8 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 0.8 ml contains 8000 international units (IU) corresponding to 67.2 micrograms epoetin alfa
Siringa mimlija għal- lest ta ’ 0. 8 ml fiha 8000 unità internazzjonali (IU) li jikkorrispondu għal 67. 2 mikrogramma ta ’ epoetin alfa
107 Posology
Pożoloġija
108 Correction phase:
108 Pazjenti pedjatriċi fuq l- emodijalisi:
109 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 fid- doża għal meta jkunu osservati figuri ta ’ l- emoglobina li jaqbżu 12 g/ dl (7. 5 mmol/ l), huma deskritti hawn taħt.
110 150 IU/ kg 3x/ week or 450 IU/ kg once weekly
150 IU/ kg 3x/ ġimgħa jew 450 IU/ kg darba fil- ġimgħa
111 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).
112 4.4 Special warnings and precautions for use
112 f’ pazjenti b’ mard koronarju, mard ta ’ l- arterji periferali, mard tal- karotide jew mard ċerebrovaskulari sever, fosthom pazjenti b’ infart mijokardijaku riċenti jew inċident ċerebrovaskulari.
113 Controlled clinical trials have not shown significant benefits attributable to the administration of epoetins when haemoglobin concentration is increased beyond the level necessary to control symptoms of anaemia and to avoid blood transfusion.
Provi kliniċi kkontrollati ma wrewx benefiċċji sinifikanti attribwibbli għall- għoti ta ’ epoetins meta l - konċentrazzjoni ta ’ l- emoglobina tiżdied aktar mil- livell meħtieġ biex tikkontrolla s- sintomi ta ’ l - anemija u biex tevita trasfużjoni tad- demm.
114 Adult surgery patients in an autologous predonation programme
Pazjenti kirurġiċi adulti fi programm ta ’ predonazzjoni awtologa
115 4.6 Pregnancy and lactation
4. 6 Tqala u treddigħ
116 thrombosis prophylaxis by administration of acetylsalicylic acid, for example, is recommended in these patients.
Reviżjoni bikrija tax- xant u profilassi tat- trombożi bl- għoti ta ’ acetylsalicylic acid, pereżempju, huwa rakkomandat f’ dawn il- pazjenti.
117 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.
118 5.2 Pharmacokinetic properties
5. 2 Tagħrif farmakokinetiku
119 6.2 Incompatibilities
6. 2 Inkompatibilitajiet
Hexal AG Industriestrasse 25 D-83607 Holzkirchen Germany
120 Industriestrasse 25 D- 83607 Holzkirchen Il- Ġermanja
Epoetin alfa HEXAL 9000 IU/ 0.9 ml solution for injection in a pre-filled syringe
Epoetin alfa HEXAL 9000 IU/ 0. 9 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 0.9 ml contains 9000 international units (IU) corresponding to 75.6 micrograms epoetin alfa
Siringa mimlija għal- lest ta ’ 0. 9 ml fiha 9000 unità internazzjonali (IU) li jikkorrispondu għal 75. 6 mikrogramma ta ’ epoetin alfa
122 Posology
Pożoloġija
123 Correction phase:
123 Pazjenti pedjatriċi fuq l- emodijalisi:
124 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 fid- doża għal meta jkunu osservati figuri ta ’ l- emoglobina li jaqbżu 12 g/ dl (7. 5 mmol/ l), huma deskritti hawn taħt.
125 150 IU/ kg 3x/ week or 450 IU/ kg once weekly
150 IU/ kg 3x/ ġimgħa jew 450 IU/ kg darba fil- ġimgħa
126 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).
127 4.4 Special warnings and precautions for use
127 f’ pazjenti b’ mard koronarju, mard ta ’ l- arterji periferali, mard tal- karotide jew mard ċerebrovaskulari sever, fosthom pazjenti b’ infart mijokardijaku riċenti jew inċident ċerebrovaskulari.
128 Controlled clinical trials have not shown significant benefits attributable to the administration of epoetins when haemoglobin concentration is increased beyond the level necessary to control symptoms of anaemia and to avoid blood transfusion.
Provi kliniċi kkontrollati ma wrewx benefiċċji sinifikanti attribwibbli għall- għoti ta ’ epoetins meta l - konċentrazzjoni ta ’ l- emoglobina tiżdied aktar mil- livell meħtieġ biex tikkontrolla s- sintomi ta ’ l - anemija u biex tevita trasfużjoni tad- demm.
129 Adult surgery patients in an autologous predonation programme
Pazjenti kirurġiċi adulti fi programm ta ’ predonazzjoni awtologa
130 4.6 Pregnancy and lactation
4. 6 Tqala u treddigħ
131 thrombosis prophylaxis by administration of acetylsalicylic acid, for example, is recommended in these patients.
Reviżjoni bikrija tax- xant u profilassi tat- trombożi bl- għoti ta ’ acetylsalicylic acid, pereżempju, huwa rakkomandat f’ dawn il- pazjenti.
132 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.
133 5.2 Pharmacokinetic properties
5. 2 Tagħrif farmakokinetiku
134 6.2 Incompatibilities
6. 2 Inkompatibilitajiet
Hexal AG Industriestrasse 25 D-83607 Holzkirchen Germany
135 Industriestrasse 25 D- 83607 Holzkirchen Il- Ġermanja
Epoetin alfa HEXAL 10 000 IU/ 1 ml solution for injection in a pre-filled syringe
Epoetin alfa HEXAL 10, 000 IU/ 1 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 1 ml contains 10 000 international units (IU) corresponding to 84.0 micrograms epoetin alfa
Siringa mimlija għal- lest ta ’ 1 ml fiha 10, 000 unità internazzjonali (IU) li jikkorrispondu għal 84. 0 mikrogramma ta ’ epoetin alfa
137 Posology
Pożoloġija
138 Correction phase:
138 Pazjenti pedjatriċi fuq l- emodijalisi:
139 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 fid- doża għal meta jkunu osservati figuri ta ’ l- emoglobina li jaqbżu 12 g/ dl (7. 5 mmol/ l), huma deskritti hawn taħt.
140 150 IU/ kg 3x/ week or 450 IU/ kg once weekly
150 IU/ kg 3x/ ġimgħa jew 450 IU/ kg darba fil- ġimgħa
141 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).
142 4.4 Special warnings and precautions for use
142 f’ pazjenti b’ mard koronarju, mard ta ’ l- arterji periferali, mard tal- karotide jew mard ċerebrovaskulari sever, fosthom pazjenti b’ infart mijokardijaku riċenti jew inċident ċerebrovaskulari.
143 Controlled clinical trials have not shown significant benefits attributable to the administration of epoetins when haemoglobin concentration is increased beyond the level necessary to control symptoms of anaemia and to avoid blood transfusion.
Provi kliniċi kkontrollati ma wrewx benefiċċji sinifikanti attribwibbli għall- għoti ta ’ epoetins meta l - konċentrazzjoni ta ’ l- emoglobina tiżdied aktar mil- livell meħtieġ biex tikkontrolla s- sintomi ta ’ l - anemija u biex tevita trasfużjoni tad- demm.
144 Adult surgery patients in an autologous predonation programme
Pazjenti kirurġiċi adulti fi programm ta ’ predonazzjoni awtologa
145 4.6 Pregnancy and lactation
4. 6 Tqala u treddigħ
146 thrombosis prophylaxis by administration of acetylsalicylic acid, for example, is recommended in these patients.
Reviżjoni bikrija tax- xant u profilassi tat- trombożi bl- għoti ta ’ acetylsalicylic acid, pereżempju, huwa rakkomandat f’ dawn il- pazjenti.
147 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.
148 5.2 Pharmacokinetic properties
5. 2 Tagħrif farmakokinetiku
149 6.2 Incompatibilities
6. 2 Inkompatibilitajiet
Hexal AG Industriestrasse 25 D-83607 Holzkirchen Germany
150 Industriestrasse 25 D- 83607 Holzkirchen Il- Ġermanja
151 ANNEX II
151 ANNESS II
The educational leaflet shall contain the following key elements: • That the use of epoetin alfa products can cause immunogenicity which in rare cases may lead to Pure Red Cell Aplasia (PRCA) • That with other epoetin products, the risk of immunogenicity in Chronic Kidney Disease (CKD) is increased with the subcutaneous (sc) route. • There is insufficient data on Epoetin alfa HEXAL to know the size of any increased immunogenicity risk with subcutaneous use • Therefore, the sc route is not recommended for patients with CKD • The loss of efficacy or other symptoms of the development of immunogenicity should be investigated • Any suspected case of Pure Red Cell Aplasia or development of immunogenicity should be reported to the MAH
Il- fuljett edukattiv għandu jkun fih l- elementi importanti li ġejjin: • Li l- użu tal- prodotti li fihom epoetin alfa jista ’ jikkawża immunoġeniċità li f’ każijiet rari tista ’ twassal għal Aplasija taċ- Ċelluli l- Ħomor Pura (PRCA) • Li ma ’ prodotti oħrajn ta ’ epoetin, ir- riskju ta ’ immunoġeniċità f’ Mard Kroniku tal- Kliewi (CKD) jiżdied meta jingħata minn taħt il- ġilda (sc). • Hemm informazzjoni insuffiċjenti fuq Epoetin alfa HEXAL biex ikun magħruf il- kobor ta ’ xi żieda fir- riskju ta ’ immunoġeniċità bl- użu minn taħt il- ġilda • Għalhekk, ir- rotta ta ’ taħt il- ġilda mhix rakkomandata għal pazjenti li għandhom CKD • It- telf ta ’ effikaċja jew sintomi oħrajn ta ’ l- iżvilupp ta ’ immunoġeniċità għandhom ikunu investigati • Kwalunkwe każ issuspettat ta ’ Aplasija taċ- Ċelluli l- Ħomor Pura jew l- iżvilupp ta ’ immunoġeniċità għandhom ikunu rrappurtati lill- MAH
The MAH must ensure that the system of pharmacovigilance, as described in version 3.0 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
153 L- MAH irid jiżgura li s- sistema ta ’ farmakoviġilanza, kif deskritt f’ verżjoni 3. 0, ippreżentata f’ Modulu 1. 8. 1. ta ’ l- Applikazzjoni ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq, tkun implimentata u taħdem qabel ma l- prodott jitpoġġa fuq is- suq.
153 Risk Management plan
Pjan dwar l- Immaniġġjar tar- Riskju
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in Version 5 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
L- MAH irid jikkommetti ruħu li jwettaq l- istudji u attivitajiet addizzjonali ta ’ farmakoviġilanza deskritti fil- Pjan tal- Farmakoviġilanza, kif maqbul f’ verżjoni 5 tal- Pjan dwar l- Immaniġġjar tar- Riskju (RMP) ippreżentat f’ Modulu 1. 8. 2. ta ’ l- Applikazzjoni ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq, u kwalunkwe aġġornamenti sussegwenti tal- RMP li kienu maqbula mis- CHMP.
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
Skond il- Linja Gwida tas- CHPM dwar is- Sistemi ta ’ l- Immaniġġjar tar- Riskju għal prodotti mediċinali għall- użu uman, l- RMP aġġornat għandu jintbagħat fl- istess ħin mar- Rapport Perjodiku dwar l - Aġġornament tas- Sigurtà (PSUR) li jkun imiss.