qanastek/EMEA-V3 huggingface dataset:
No special dosage adjustments are required in elderly patients.
L- ebda aġġustamenti speċjali fid- dożaġġ m’ huma meħtieġa f’ pazjenti anzjani.
Patients with homozygous sickle cell disease and renal failure should where possible be maintained at ic
Pazjenti li għandhom il- homozygous sickle cell disease u kollass tal- kliewi għandhom, fejn ikun m
a total haemoglobin concentration between 7 and 9 g/ dl. ed
possibbli, jinżammu f’ konċentrazzjoni totali ta ’ l- emoglobina bejn 7 u 9 g/ dl.
Due to limited experience, the safety and efficacy of Dynepo could not be assessed in patients with M
Minħabba esperjenza limitata, l- effikaċja u s- sigurtà ta ’ Dynepo ma jistgħux ikunu evalwati f’ pazjenti t
impaired liver function.
b’ indeboliment fil- funzjoni tal- fwied. ot od
4.3 Contra-indications
4. 3 Kontra- indikazzjonijiet
Hypersensitivity to the active substance or to any of the excipients.
Pr
11 In clinical trials, an increased risk of death and serious cardiovascular events was observed when erythropoiesis stimulating agents (ESAs) were administered to target a haemoglobin of greater than 12 g/ dL (7.5 mmol/ l).
11 ngħataw mediċini li jistimulaw l- erythropoiesis (ESAs) biex jinkiseb livell ta ’ emoglobina ta ’ iktar minn 12 g/ dL (7. 5 mmol/ l).
Hypertension
t tad- demm.
Most of patients with chronic renal failure have a history of hypertension.
za aggravament ta ’ pressjoni tad- demm diġa ’ eżistenti.
Patients on Dynepo therapy can experience increase in blood pressure or aggravation of existing hypertension.
Għalhekk, għandha tingħata attenzjoni speċjali lil pazjenti li jkunu kkurati b’ Dynepo, biex isir
ed Therefore, in patients treated with Dynepo, special care should be taken to monitor closely and control blood pressure.
riz monitoraġġ mill- qrib u kontroll tal- pressjoni tad- demm.
Blood pressure should be controlled adequately before initiation and during therapy to
Jekk dawn
is avoid acute complications like hypertensive encephalopathy and related complications (seizures, stroke).
to ir- reazzjonijiet iseħħu, dawn ikollhom bżonn l- attenzjoni immedjata ta ’ tabib u kura medika intensiva.
Particular attention should be paid to sudden sharp migraine-like headaches as a possible
aw Attenzjoni partikulari għandha tingħata lill- uġigħ ta ’ ras qisu emigranja, li jiġi għall- għarrieda, għax dan ikun possibbilment sinjal ta ’ twissija.
Increases in blood pressure may require treatment with anti-hypertensive medicines or dosing increase of
Żidiet fil- pressjoni tad- demm jista ’ jkollhom bżonn kura b’ mediċini kontra l- pressjoni jew żieda fid - dożaġġ ta ’ mediċini eżistenti kontra l- pressjoni għolja.
au existing anti-hypertensive medications.
x tingħata għandha tiġi kkunsidrata.
er Once hypertension is controlled with more intensified therapy, Dynepo therapy should be re-started at a reduced dose. ng Iron evaluation lo
Ġaladarba l- pressjoni tad- demm għolja tkun ikkontrollata b’ terapija iktar intensiva, it- terapija b’ Dynepo ħa għandha tinbeda mill- ġdid b’ doża mnaqqsa.
During Dynepo therapy, absolute or functional iron deficiency may develop.
Evalwazzjoni tal- livell tal- ħadid ’ g Matul it- terapija b’ Dynepo, tista ’ tiżviluppa defiċjenza assoluta jew funzjonali tal- ħadid.
This is the most common no
Din hi l- iktar kawża komuni ta ’ rispons inkomplet għat- terapija eritropojetika. im
cause of an incomplete response to an erythropoietin therapy.
Għalhekk, qabel u matul it- terapija b’ Dynepo, il- ħażna tal- ħadid tal- pazjent, li tinkludi s- saturazzjoni ta ’ transferrin u serum ferritin, għandha tiġi evalwata.
Therefore, prior to and during Dynepo therapy, the patient's iron stores, including transferrin saturation and serum ferritin, should be evaluated.
Is- saturazzjoni ta ’ transferrin għandha tkun mill - inqas 20%, u dik ta ’ ferritin għandha tkun mill- inqas 100 ng/ ml.
Transferrin saturation should be at least 20%, and ct
Jekk is- saturazzjoni ta ’ transferrin il
ferritin should be at least 100 ng/ ml.
taqa ’ taħt 20%, jew jekk ferritin jaqa ’ taħt 100 ng/ ml, għandu jingħata l- ħadid.
If transferrin saturation falls below 20%, or if ferritin falls below du
Eventwalment kważi l - al
Virtually all patients will eventually require supplemental iron to increase or maintain transferrin saturation and ferritin to levels that will adequately support ro
pazjenti kollha ser ikunu jeħtieġu suppliment tal- ħadid biex iżidu jew iżommu s- saturazzjoni ta ’ transferrin u ferritin għal livelli li jissapportjaw b’ mod adegwat l- erythropoiesis stimulata minn in
erythropoiesis stimulated by Dynepo.
Dynepo.
Anaemia in epoetin-resistant or hyporesponsive patients with failure to respond to 20,000 IU/ week lp
L- anemija f’ pazjenti li huma reżistenti jew iporisponsivi għal epoetin u ma jirrispondux għal 20, 000 iċ
should be investigated, including referral to a haematologist. a
Dan għandu jinkludi li jiġu riferuti għand ematoloġista. ed
In the iron-replete patient with an inadequate response to Dynepo therapy, the following conditions in
F’ pazjenti li jkollhom ħadid biżżejjed iżda li jkollhom rispons inadegwat għat- terapija b’ Dynepo, il - kundizzjonijiet li ġejjin għandhom ikunu evalwati u kkurati, jekk ikun xieraq: m
should be evaluated and treated, if appropriated: • Infection/ inflammation ic
• Infezzjoni/ infjammazzjoni • Telf moħbi ta ’ demm t
• Occult blood loss ed
• Iperparatirojdiżmu/ Osteitis fibrosa cystica ot
• Hyperparathyroidism/ Osteitis fibrosa cystica • Aluminium intoxication M
• Intossikazzjoni ta ’ l- aluminju • od
• Haemoglobinopathies such as thalassaemia or sickle cell anaemia • Vitamin deficiencies, i. e., folic acid or vitamin B12 deficiencies • Haemolysis • Malignant diseases including multiple myeloma and myelodysplastic syndrome • Malnutrition
Emoglobinopatiji bħal talessimja jew sickle cell anaemia • Defiċjenzi tal- vitamini, i. e., defiċjenzi tal- folic acid jew ta ’ vitamina B12 • Emolisi Pr
Laboratory monitoring
• Mard malinn li jinkludi mjeloma multipla u s- sindrome mjelodisplastiku • Nuqqas ta ’ ikel sustanzjuż
The haemoglobin level should be determined once a week until it has stabilised in the suggested target range and the maintenance dose has been established.
Il- livell ta ’ l- emoglobina għandu jiġi stabbilit darba f’ ġimgħa sakemm jistabbilizza fil- medda ssuġġerita tal- mira, u d- doża tal- manutenzjoni tkun ġiet stabbilita.
After any dose adjustment, the haemoglobin
Wara kwalunkwe aġġustament tad - doża, l- emoglobina għandha wkoll tiġi stabbilita darba f’ ġimgħa sakemm tistabbilizza fil- medda tal -
12 should also be determined once weekly until it has stabilised in the target range.
12 mira.
Serum chemistry values including creatinine and potassium should be monitored regularly during Dynepo therapy.
Il- valuri tal- kimika tas- serum, li jinkludu kreatinina u potassium, għandhom jiġu mmonitorjati regolarment matul it- terapija b’ Dynepo.
The use of Dynepo in nephrosclerotic patients not yet undergoing dialysis should be defined
L- użu ta ’ Dynepo f’ pazjenti nefrosklerotiċi li għad mhux qed issirilhom id- dijaliżi, għandu jiġi definit
ed individually, as a possible acceleration of progression of renal failure cannot be ruled out with certainty.
t za individwalment, għax il- possibbiltà ta ’ l- aċċelerazzjoni tal- progressjoni tal- kollass tal- kliewi ma tistax tiġi eskluża b’ ċertezza.
is During haemodialysis, patients treated with Dynepo may require increased anticoagulation treatment
riz Matul l- emodijaliżi, il- pazjenti kkurati b’ Dynepo jista ’ jkollhom bżonn ta ’ żieda fil- kura kontra l - koagulazzjoni biex jiġi evitat it- tagħqid tad- demm tas- shunt arterjo- venuża.
or to prevent clotting of the arterio-venous shunt.
to L- użu ħażin ta ’ epoetin minn persuni b’ saħħithom jista ’ jwassal għal żieda eċċessiva fl- emoglobina u fl -
th Misuse of epoetin by healthy persons may lead to an excessive increase in haemoglobin and haematocrit.
aw ematokrit.
This may be associated with life-threatening cardiovascular complications.
Dan jista ’ jkun assoċjat ma ’ komplikazzjonijiet kardjovaskulari ta ’ periklu għall- ħajja.
au 4.5 Interaction with other medicinal products and other forms of interaction
4. 5 Interazzjoni ma prodotti oħra mediċinali u forom oħra ta` interazzjoni.
No interaction studies have been performed. er ng No interactions have been reported during treatment with Dynepo in the course of clinical trials. lo
x du L- ebda studji ma saru fuq interazzjoni ta` mediċini oħra ma` Dynepo
4.6 Pregnancy and lactation no
L- ebda interazzjonijiet ma kienu rrappurtati matul il- kura b’ Dynepo sakemm damu jsiru l- provi ħa kliniċi. ’ g 4. 6 Tqala u treddigħ im
Animal studies are insufficient with respect to effects on pregnancy (see section 5.3).
Studji fuq il- bhejjem rigward l- effetti fuq it- tqala (ara sezzjoni 5. 3) m’ humiex suffiċjenti.
The potential risk for humans is unknown.
Ir - riskju potenzjali għall- bnedmin mhuwiex magħruf.
In case of its use during pregnancy, concomitant iron substitution should be considered in the mother. du
F’ każ ta ’ l- użu tagħha matul it- tqala, l- użu fl- istess ħin ta ’ il
Since many compounds are excreted in human milk, caution should be advised when Dynepo is administered to breast-feeding ro
komposti jitneħħew fil- ħalib uman, għandha tingħata attenzjoni meta Dynepo jingħata li nisa li jkunu in
women. lp
qed ireddgħu. iċ
4.7 Effects on ability to drive and use machines a
4. 7 Effetti fuq is- sewqan u l- użu ta ’ magni ed
Dynepo has no or negligible influence on the ability to drive and use machines. in ic
Dynepo m’ għandu l- ebda influwenza, jew influwenza negliġibbli, fuq il- ħila biex issuq jew tħaddem magni. m
4.8 Undesirable effects ed
4. 8 Effetti mhux mixtieqa t ot
The most common are hypertension, access related thrombosis and headache.
Madwar 10% tal- pazjenti huma mistennija li jġarrbu reazzjoni avversa tal- mediċina L- iktar komuni huma pressjoni tad- demm għolja, trombożi marbuta ma ’ l- aċċess u wġigħ ta ’ ras.
Clinical experience with epoetins M
Esperjenza klinika od
The frequency of adverse events that were experienced during Dynepo therapy is tabulated below.
Il- frekwenza ta ’ avvenimenti avversi li seħħew matul it- terapija b’ Dynepo huma elenkati hawn taħt.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness:
F’ kull sezzjoni ta ’ frekwenza, l- effetti mhux mixtieqa għandhom jitniżżlu skond is- serjetà tagħhom.
(
Disturbi tad- demm u tas - sistema limfatika:
(> 1/ 1,000, < 1/ 100)
(> 1/ 1, 000, < 1/ 100) Poliċitemija Tromboċitosi
Gastrointestinal disorders:
t za Disturbi gastro- intestinali:
Diarrhoea Nausea
Dijarea
is
riz Dardir
Skin and subcutaneous
Disturbi fil- ġilda u fit -
or tissues disorders:
to tessuti ta ’ taħt il- ġilda:
Injection site reaction (e. g. pain,
Reazzjoni fis- sit ta ’ l - injezzjoni (eż. uġigħ, emorraġija)
er haemorrhage) Flu-syndrome ng Increases in serum chemistry values including creatinine and potassium have been observed (see section lo
x Sindrome ta ’
4.4). no
du influwenza ħa Żidiet fil- valuri tal- kimika fis- serum li jinkludu l- krejatinina u l- potassium kienu osservati (ara sezzjoni 4. 4). ’ g
If the suggested target range is exceeded, treatment with epoetin delta should be temporarily withdrawn until the haemoglobin/ haematocrit returns to the suggested target ro
Jekk tinqabeż il- medda tal- mira ssuġġerita, il- kura b’ epoetin delta għandha tiġi temporanjament imwaqqfa sakemm l- emoglobina/ ematokrit terġa ’ lura in
range.
fil- medda tal- mira ssuġġerita.
14 During the clinical trials, there were no indications of development of neutralising antibodies to epoetin delta in humans based on the clinical response.
14 jinnewtralizzaw, għal epoetin delta fil- bnedmin, ibbażati fuq ir- rispons kliniku.
Erythropoietin receptors
Erythropoietin hu fattur tat- tkabbir (growth factor) li primarjament jistimula l- produzzjoni taċ- ċelluli l -
ed may be expressed on the surface of a variety of tumour cells.
Ir- riċetturi ta ’ erythropoietin jistgħu jkunu espressi fuq il- wiċċ ta ’ varjetà ta ’ ċelluli tat- tumur
Survival and tumour progression have been examined in five large controlled studies of epoetin alfa,
Is- sopravivenza u l- progressjoni tat- tumur kienu eżaminati f’ ħames studji kbar ikkontrollati ta ’ epoetin
is beta and darbepoetin alfa involving a total of 2,833 patients, of which four were double-blind placebo-
Tnejn mill- istudji kienu
Two of the studies recruited patients who were being treated with chemotherapy.
to jinkludu pazjenti li kienu qed ikunu kkurati bil- kimoterapija.
The target haemoglobin concentration in two studies was > 13 g/ dL;
Fl -
th in the remaining three studies it was 12-14 g/ dL.
aw istudju open- label ma kien hemm l- ebda differenza fis- sopravivenza totali bejn pazjenti kkurati b’ erythropoietin uman rikombinanti u l- kontrolli.
In the open-label study there was no difference in overall survival between patients treated with recombinant human erythropoietin and controls.
Fl- erba ’ studji kkontrollati bil- plaċebo, il - proporzjonijiet tal- periklu għas- sopravivenza totali varjaw bejn 1. 25 u 2. 47 favur il- kontrolli.
In the
Dawn l -
These studies have shown a consistent unexplained statistically significant excess
x 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
er mortality in patients who have anaemia associated with various common cancers who received recombinant human erythropoietin compared to controls.
du erythropoietin uman rikombinanti, meta mqabbla mal- kontrolli.
Overall survival outcome in the trials could ng not be satisfactorily explained by differences in the incidence of thrombosis and related complications between those given recombinant human erythropoietin and those in the control group. lo
Ir- riżultat totali tas- sopravivenza fil - provi ma setax ikun spjegat b’ mod sodisfaċenti mid- differenzi fl- inċidenza ta ’ trombożi u ħa kumplikazzjonijiet marbuta bejn dawk il- pazjenti li ngħataw erythropoietin uman rikombinanti u dawk fil- grupp tal- kontroll. ’ g
A systematic review has also been performed involving more than 9000 cancer patients participating no
Saret ukoll evalwazzjoni sistematika li kienet tinvolvi iktar minn 9000 pazjent bil- kanċer li kienu qed im
in 57 clinical trials.
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 ’ dejta dwar is- sopravivenza totali, ipproduċiet hazard ratio point estimate ta ’ 1. 08 favur il- kontrolli (95% CI:
1.35, 2.06, 35 trials and 6769 patients) was observed in ct
1. 35, 2. 06, 35 prova u il
patients treated with recombinant human erythropoietin.
6769 pazjent) kienet osservata f’ pazjenti kkurati b’ erythropoietin uman rikombinanti.
There is therefore consistent evidence to suggest that there may be significant harm to patients with cancer who are treated with recombinant du
Għalhekk, hemm evidenza konsistenti li tissuġġerixxi li jista ’ jkun hemm ħsara sinifikanti lil pazjenti bil- kanċer li al
human erythropoietin.
jkunu kkurati b’ erythropoietin uman rikombinanti.
The extent to which these outcomes might apply to the administration of recombinant human erythropoietin to patients with cancer, treated with chemotherapy to achieve ro
Il- grad sa fejn dawn riżultati jistgħu japplikaw għall- għoti ta ’ erythropoietin uman rikombinanti lil pazjenti bil- kanċer, ikkurati bil- kimoterapija biex in
haemoglobin concentrations less than 13 g/ dL, is unclear because few patients with these characteristics were included in the data reviewed.
jintlaħqu konċentrazzjonijiet ta ’ emoglobina ta ’ inqas minn 13 g/ dL, mhuwiex ċar minħabba li ftit iċ
cancer patients that are being treated with Dynepo for anaemia associated with chronic renal failure have not been investigated.
pazjenti b’ dawn il- karatteristiċi kienu inklużi fid- dejta li kienet evalwata.
The extent to which the outcomes observed in the clinical studies a
Ir- riżultati dwar is - sopravivenza u l- progressjoni tat- tumur f’ pazjenti bil- kanċer li kienu qed jiġu kkurati b’ Dynepo għall - ed
discussed above may apply to this patient population is unclear, specifically considering that the in
Il- grad sa fejn ir- riżultati osservati fl- istudji kliniċi diskussi hawn fuq jistgħu japplikaw għal din il- popolazzjoni ta ’ pazjenti, m
dosages administered in the renal indication are lower than in the cancer indication. ic
mhix ċara, speċifikament meta wieħed jikkunsidra li d- dożaġġi li ngħataw fl- indikazzjoni renali huma iktar baxxi mill- indikazzjoni tal- kanċer. t
5.2 Pharmacokinetic properties ed
5. 2 Tagħrif farmakokinetiku ot od
The pharmacokinetics of erythropoietin following administration of epoetin delta has been examined M
Il- farmakokinetiċi ta ’ erythropoietin wara l- għoti ta ’ epoetin delta kienu eżaminati kemm f’ voluntiera b’ saħħithom u kemm f’ pazjenti b’ kollass kroniku tal- kliewi.
Following intravenous doses, volume of distribution approximates total blood volume and ranges from 0.063 to 0.097 l/ kg.
Il- half- life ta ’ l - Pr
15 5.3 Preclinical safety data
15 hi bejn 26% u 36%.
ed 6.1 List of excipients
riz 6. 1 Lista ta ’ sustanzi mhux attivi
Sodium phosphate monobasic, monohydrate
to Sodium phosphate monobasic, monohydrate Sodium phosphate dibasic, heptahydrate
Keep the syringes in the outer carton to protect from du
Żomm is- siringi fil- kartuna ta ’ barra sabiex al
light.
tipproteġihom mid- dawl. in
When given subcutaneously, the site of injection should be rotated with each administration.
16 Meta jingħata taħt il- ġilda, is- sit ta ’ injezzjoni għandu jinbidel ma ’ kull għotja.
16 The syringe is pre-assembled with a needle safety guard to prevent needle stick injury.
Is- siringa hi mmuntata minn qabel bi protezzjoni għas- sigurtà tal- labra biex jiġi evitat korriment ikkawżat mit- tingiż tal- labra.
This does not affect normal operation of the syringe and the syringe can be rotated in the device..
Dan ma jaffettwax l- operat normali tas- siringa u s- siringa tista ’ tiddawwar fit- tagħmir.
ed United Kingdom
aw Chineham, Basingstoke Hampshire, RG24 8EP Renju Unit
is 8.
x du 8.
or EU/ 1/ 02/ 211/ 002
NUMRU( I) TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ ħa EU/ 1/ 02/ 211/ 002 ’ g
er Date of first authorisation:
Data ta ’ l- ewwel awtorizzazzjoni:
DATE OF REVISION OF THE TEXT lo
DATA TA ’ META ĠIET RIVEDUTA L- KITBA in iċ
Detailed information on this medicinal product is available on the website of the European Medicines no
Informazzjoni dettaljata dwar dan il- prodott tinsab fuq il- website ta ’ l- Aġenzija Ewropea dwar il - Mediċini (EMEA) http: // www. emea. europa. eu / ed m t ot od Pr
Dynepo 3,000 IU/ 0.3 ml solution for injection in a pre-filled syringe.
Dynepo 3, 000 IU/ 0. 3 ml soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest.
Pre-filled syringe containing 3,000 IU per 0.3 ml dose (10,000 IU/ ml) of the active substance epoetin delta.
Siringa mimlija għal- lest li fiha 3, 000 IU f’ kull doża ta ’ 0. 3 ml (10, 000 IU/ ml) tas- sustanza attiva epoetin delta.
It may be used in patients on dialysis and in patients not on dialysis. lo
Jista ’ jintuża kemm f’ pazjenti li huma fuq id- dijaliżi kif ukoll f’ pazjenti li mhumiex fuq id- dijaliżi. ’ g
4.2 Posology and method of administration no
4. 2 Pożoloġija u metodu ta ’ kif għandu jingħata im
Treatment with Dynepo should be initiated by physicians experienced in the treatment of anaemia associated with CRF. ct
Il- kura b’ Dynepo għandha tinbeda minn tobba li għandhom esperjenza fil- kura ta ’ anemija assoċjata ma ’ CRF. il
The dosage of Dynepo must be adjusted individually to maintain the level of haemoglobin within the du
Id- dożaġġ ta ’ Dynepo jrid ikun aġġustat individwalment biex iżomm il- livell ta ’ l- emoglobina fil - al
target range of 10 to 12g/ dl. ro
medda tal- mira ta ’ 10 sa 12g/ dl. in
Dynepo lp
Sintomi ta ’ anemija u kundizzjonijiet jew mard b’ konsegwenza tagħha jistgħu jvarjaw ma ’ l- età, sess, iċ
Subcutaneous use is preferable in patients who are not receiving a
Dynepo għandu jingħata minn taħt il- ġilda jew ġol- vina biex iżid l- emoglobina ed
haemodialysis to avoid puncture of peripheral veins. in
għal mhux iktar minn 12 g/ dL (7. 5 mmol/ l).
Due to intra-patient variability, occasional individual haemoglobin values for a patient above and ic
L- użu taħt il- ġilda hu preferibbli f’ pazjenti li mhux qed jirċievu l- emodijalisi biex jevitaw li jtaqqbu vini periferali m
Haemoglobin variability should be addressed ed
Il- varjabilità ta ’ l- emoglobina għandha tkun t ot
through dose management, with consideration for the haemoglobin target range of 10 g/ dL (6.2 mmol/ l) to 12g/ dL (7.5mmol/ l).
indirizzata permezz ta ’ l- immaniġġjar tad- doża, b’ konsiderazzjoni għall- medda tal- mira ta ’ l - emoglobina ta ’ 10 g/ dL (6. 2 mmol/ l) sa 12 g/ dL (7. 5 mmol/ l).
A sustained haemoglobin level of greater than 12 g/ dL M
Livell sostnut ta ’ emoglobina ta ’ iktar od
(7.5 mmol/ l) should be avoided; guidance for appropriate dose adjustment for when haemoglobin values exceeding 12 g/ dL (7.5mmol/ l) are observed, are described below (see Dose Management section below).
Pr
Starting dose is 50 IU/ kg three times a week if administered intravenously.
18 Immaniġġjar tad- Doża Id- doża tal- bidu hi ta ’ 50 IU/ kg tliet darbiet f’ ġimgħa jekk tingħata ġol- vina.
19 In clinical trials, an increased risk of death and serious cardiovascular events was observed when erythropoiesis stimulating agents (ESAs) were administered to target a haemoglobin of greater than 12 g/ dL (7.5 mmol/ l).
19 ngħataw mediċini li jistimulaw l- erythropoiesis (ESAs) biex jinkiseb livell ta ’ emoglobina ta ’ iktar minn 12 g/ dL (7. 5 mmol/ l).
20 The haemoglobin level should be determined once a week until it has stabilised in the suggested target range and the maintenance dose has been established.
20 mira.
Other
Oħrajn Għalkemm ma kinux osservati b’ Dynepo, minħabba li reazzjonijiet anafilattojdi jistgħu jseħħu b’ erythropoietin, hu rrakkomandat li l- ewwel doża tingħata taħt superviżjoni medika.
Although it has not been observed with Dynepo, since anaphylactoid reactions may occur with erythropoietin, it is recommended that the first dose be administered under medical supervision.
L- użu ta ’ Dynepo f’ pazjenti nefrosklerotiċi li għad mhux qed issirilhom id- dijaliżi, għandu jiġi definit
ed The use of Dynepo in nephrosclerotic patients not yet undergoing dialysis should be defined individually, as a possible acceleration of progression of renal failure cannot be ruled out with
t za individwalment, għax il- possibbiltà ta ’ l- aċċelerazzjoni tal- progressjoni tal- kollass tal- kliewi ma tistax tiġi eskluża b’ ċertezza.
or During haemodialysis, patients treated with Dynepo may require increased anticoagulation treatment
riz Matul l- emodijaliżi, il- pazjenti kkurati b’ Dynepo jista ’ jkollhom bżonn ta ’ żieda fil- kura kontra l - koagulazzjoni biex jiġi evitat it- tagħqid tad- demm tas- shunt arterjo- venuża.
th to prevent clotting of the arterio-venous shunt.
to L- użu ħażin ta ’ epoetin minn persuni b’ saħħithom jista ’ jwassal għal żieda eċċessiva fl- emoglobina u fl -
au Misuse of epoetin by healthy persons may lead to an excessive increase in haemoglobin and haematocrit.
aw ematokrit.
4.5 er Interaction with other medicinal products and other forms of interaction ng No interaction studies have been performed. lo
4. 5 Interazzjoni ma prodotti oħra mediċinali u forom oħra ta` interazzjoni.
No interactions have been reported during treatment with Dynepo in the course of clinical trials. no
x du L- ebda studji ma saru fuq interazzjoni ta` mediċini oħra ma` Dynepo
4.6 Pregnancy and lactation ct
L- ebda interazzjonijiet ma kienu rrappurtati matul il- kura b’ Dynepo sakemm damu jsiru l- provi ħa kliniċi. ’ g 4. 6 Tqala u treddigħ im
Caution should be exercised when prescribing to pregnant du
Wieħed għandu joqgħod attent meta jikteb riċetta għal din il- mediċina għal nisa tqal.
In case of its use during pregnancy, concomitant iron substitution should be considered in the mother. ro
F’ każ ta ’ l- użu tagħha matul it- tqala, l- użu fl- istess ħin ta ’ il
Since many compounds are excreted in human milk, caution should be advised when Dynepo is administered to breast-feeding lp
komposti jitneħħew fil- ħalib uman, għandha tingħata attenzjoni meta Dynepo jingħata li nisa li jkunu in
women. a
qed ireddgħu. iċ
4.7 Effects on ability to drive and use machines in ic
4. 7 Effetti fuq is- sewqan u l- użu ta ’ magni ed
Dynepo has no or negligible influence on the ability to drive and use machines. ed
Dynepo m’ għandu l- ebda influwenza, jew influwenza negliġibbli, fuq il- ħila biex issuq jew tħaddem magni. m
4.8 Undesirable effects M
4. 8 Effetti mhux mixtieqa t ot
Approximately 10% of patients can be expected to experience an adverse drug reaction.
Madwar 10% tal- pazjenti huma mistennija li jġarrbu reazzjoni avversa tal- mediċina L- iktar komuni huma pressjoni tad- demm għolja, trombożi marbuta ma ’ l- aċċess u wġigħ ta ’ ras.
The most common are hypertension, access related thrombosis and headache.
Esperjenza klinika od
Clinical experience with epoetins suggest hypertension and thrombosis risk may be reduced by titrating the dose to maintain haemoglobin levels between 10 to 12 g/ dl.
Pr
administration site
Trombożi marbuta
thrombosis
Uġigħ
conditions:
kundizzjonijiet ta ’ mnejn jingħata:
(e. g. pain,
ma ’ l- aċċess
haemorrhage)
Reazzjoni fis- sit ta ’ l - injezzjoni (eż. uġigħ, emorraġija)
er ng Flu-syndrome
x Sindrome ta ’
Increases in serum chemistry values including creatinine and potassium have been observed (see section 4.4). lo
du influwenza ħa Żidiet fil- valuri tal- kimika fis- serum li jinkludu l- krejatinina u l- potassium kienu osservati (ara sezzjoni 4. 4). ’ g
4.9 Overdose no
4. 9 Doża eċċessiva im
The maximum dose of epoetin delta that can be safely administered in single or multiple doses has not been determined. ct
Id- doża massima ta ’ epoetin delta li tista ’ tingħata b’ mod sikur f’ doża waħidha jew f’ dożi multipli ma ġietx stabbilita. il
Treatment can result in polycythaemia if the haemoglobin/ haematocrit is not carefully monitored and du
Il- kura tista ’ tirriżulta f’ poliċitemija jekk l- emoglobina/ ematokrit ma tkunx immonitorjata bl - al
the dose appropriately adjusted.
attenzjoni u d- doża tkun aġġustata kif suppost.
If severe polycythaemia occurs, conventional methods (phlebotomy) may be indicated to decrease the haemoglobin level. a in ic
Jekk isseħħ poliċitemija severa, metodi konvenzjonali (flebotomija) jistgħu jkunu indikati biex inaqqsu l- livell ta ’ l- emoglobina. m
B03XA..
Pr
22 During the clinical trials, there were no indications of development of neutralising antibodies to epoetin delta in humans based on the clinical response.
22 jinnewtralizzaw, għal epoetin delta fil- bnedmin, ibbażati fuq ir- rispons kliniku.
23 The bioavailability of subcutaneously administered epoetin delta is between 26% and 36%.
Il- bijodisponibilità ta ’ epoetin delta mogħti taħt il- ġilda
5.3 Preclinical safety data
23 hi bejn 26% u 36%.
is Sodium phosphate monobasic, monohydrate
to Sodium phosphate monobasic, monohydrate Sodium phosphate dibasic, heptahydrate
or Sodium phosphate dibasic, heptahydrate Polysorbate 20
aw Polysorbate 20 Sodium chloride Water for injections
er In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal ng products. lo 6.3 Shelf-life no
Minħabba li ma sarux studji li juru liema huma l- prodotti mediċinali li ma jaqblux miegħu, dan il - ħa prodott m’ għandux jitħallat ma ’ prodotti mediċinali oħrajn. ’ g 6. 3 Żmien kemm idum tajjeb il- prodott mediċinali im
light. ro
tipproteġihom mid- dawl. in
Unopened pre-filled syringes may be kept un-refrigerated but below 25oC for a single maximum period of 5 days.
minn 25oC għal perjodu wieħed sa massimu ta ’ 5 ijiem.
The revised expiry date for storage at below 25oC must not exceed the expiry date set in lp
Id- data ta ’ skadenza riveduta għal ħażna f’ temperatura ta ’ inqas minn 25oC ma tridx taqbeż id- data ta ’ skadenza stabbilita skond iż- żmien kemm ed
accordance with the 24 month shelf-life.
idum tajjeb ta ’ 24 xahar.
Following 5 days storage at below 25oC the pre-filled syringes must be discarded. a in
Wara 5 ijiem maħżuna f’ temperatura ta ’ inqas minn 25oC is- siringi mimlija għal - lest għandhom jintremew. m
6.5 Nature and contents of container ic
6. 5 In- natura tal- kontenitur u ta ’ dak li hemm ġo fih t ot
Prefilled Type I glass syringe with bromobutyl rubber stopper, 27 gauge stainless steel needle with ed
Siringi mimlija għal- lest tal- ħġieġ ta ’ Tip 1 b’ tapp tal- lastku tal- bromobutyl, labra ta ’ l- azzar li ma jsaddadx 27 gauge.
rigid natural rubber and polystyrene needle shield, polystyrene plunger rod and a needle safety guard.
polystyrene u protezzjoni tas- sigurtà tal- labra.
Packs of 6 pre-filled syringes are available.
Pakketti ta ’ 6 siringi mimlija għal- lest huma disponibbli.
When given subcutaneously, the site of injection should be rotated with each administration.
24 Meta jingħata taħt il- ġilda, is- sit ta ’ injezzjoni għandu jinbidel ma ’ kull għotja.
24 The syringe is pre-assembled with a needle safety guard to prevent needle stick injury.
Is- siringa hi mmuntata minn qabel bi protezzjoni għas- sigurtà tal- labra biex jiġi evitat korriment ikkawżat mit- tingiż tal- labra.
This does not affect normal operation of the syringe and the syringe can be rotated in the device.
Dan ma jaffettwax l- operat normali tas- siringa u s- siringa tista ’ tiddawwar fit- tagħmir.
or EU/ 1/ 02/ 211/ 003
EU/ 1/ 02/ 211/ 003 ’ g
18 March 2007 ng lo
18 ta ’ Marzu, 2007 il al
DATE OF REVISION OF THE TEXT no
DATA TA ’ META ĠIET RIVEDUTA L- KITBA in iċ
Dynepo 4,000 IU/ 0.4 ml solution for injection in a pre-filled syringe.
Dynepo 4, 000 IU/ 0. 4 ml soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest.
Pre-filled syringe containing 4,000 IU per 0.4 ml dose (10,000 IU/ ml) of the active substance epoetin delta.
Siringa mimlija għal- lest li fiha 4, 000 IU f’ kull doża ta ’ 0. 4 ml (10, 000 IU/ ml) tas- sustanza attiva epoetin delta.
Solution for injection in a pre-filled syringe
to Soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest.
It may be used in patients on dialysis and in patients not on dialysis. ng lo 4.2 Posology and method of administration no
Jista ’ jintuża kemm f’ pazjenti li huma fuq id- dijaliżi kif ukoll f’ pazjenti li mhumiex fuq id- dijaliżi. ’ g
The dosage of Dynepo must be adjusted individually to maintain the level of haemoglobin within the target range of 10 to 12g/ dl. du
medda tal- mira ta ’ 10 sa 12g/ dl. in
Anaemia symptoms and sequelae may vary with age, gender, and overall burden of disease; a ro
Sintomi ta ’ anemija u kundizzjonijiet jew mard b’ konsegwenza tagħha jistgħu jvarjaw ma ’ l- età, sess, iċ
Dynepo should be administered either subcutaneously or intravenously in order to increase haemoglobin to not lp
Dynepo għandu jingħata minn taħt il- ġilda jew ġol- vina biex iżid l- emoglobina ed
Subcutaneous use is preferable in patients who are not receiving haemodialysis to avoid puncture of peripheral veins. a in
L- użu taħt il- ġilda hu preferibbli f’ pazjenti li mhux qed jirċievu l- emodijalisi biex jevitaw li jtaqqbu vini periferali m
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 valuri ‘ il fuq u ‘ l isfel mil- livell mixtieq ta ’ l- emoglobina għal pazjent.
Haemoglobin variability should be addressed ic
Il- varjabilità ta ’ l- emoglobina għandha tkun t ot
through dose management, with consideration for the haemoglobin target range of 10 g/ dL ed
indirizzata permezz ta ’ l- immaniġġjar tad- doża, b’ konsiderazzjoni għall- medda tal- mira ta ’ l - emoglobina ta ’ 10 g/ dL (6. 2 mmol/ l) sa 12 g/ dL (7. 5 mmol/ l).
A sustained haemoglobin level of greater than 12 g/ dL (7.5 mmol/ l) should be avoided; guidance for appropriate dose adjustment for when haemoglobin M
Livell sostnut ta ’ emoglobina ta ’ iktar od
values exceeding 12 g/ dL (7.5mmol/ l) are observed, are described below (see Dose Management section below).
Pr
Starting dose is 50 IU/ kg three times a week if administered intravenously.
26 Immaniġġjar tad- Doża Id- doża tal- bidu hi ta ’ 50 IU/ kg tliet darbiet f’ ġimgħa jekk tingħata ġol- vina.
The experience in children is limited Due to limited experience, the safety and efficacy of Dynepo could not be assessed in patients with M
Minħabba esperjenza limitata, l- effikaċja u s- sigurtà ta ’ Dynepo ma jistgħux ikunu evalwati f’ pazjenti t
27 In clinical trials, an increased risk of death and serious cardiovascular events was observed when erythropoiesis stimulating agents (ESAs) were administered to target a haemoglobin of greater than 12 g/ dL (7.5 mmol/ l).
27 ngħataw mediċini li jistimulaw l- erythropoiesis (ESAs) biex jinkiseb livell ta ’ emoglobina ta ’ iktar minn 12 g/ dL (7. 5 mmol/ l).
Blood pressure should be controlled adequately before initiation and during therapy to avoid acute complications like hypertensive encephalopathy and related complications (seizures,
Il- pressjoni tad- demm għandha tiġi kkontrollata b’ mod adegwat qabel il- bidu u matul it- terapija biex jiġu evitati komplikazzjonijiet akuti bħal enċefalopatija ipertensiva u komplikazzjonijiet relatati magħha (attakki ta ’ puplesija).
is stroke).
Jekk dawn
Particular attention should be paid to sudden sharp migraine-like headaches as a possible warning signal.
to ir- reazzjonijiet iseħħu, dawn ikollhom bżonn l- attenzjoni immedjata ta ’ tabib u kura medika intensiva.
th Increases in blood pressure may require treatment with anti-hypertensive medicines or dosing increase of existing anti-hypertensive medications.
aw Attenzjoni partikulari għandha tingħata lill- uġigħ ta ’ ras qisu emigranja, li jiġi għall- għarrieda, għax dan ikun possibbilment sinjal ta ’ twissija.
In addition, a reduction of the administered dose of Dynepo
Flimkien ma ’ dan, tnaqqis tad- doża ta ’ Dynepo li
au needs to be considered.
x tingħata għandha tiġi kkunsidrata.
Therefore, prior to and during Dynepo therapy, the patient's iron stores, including transferrin saturation and serum ferritin, should be evaluated.
Għalhekk, qabel u matul it- terapija b’ Dynepo, il- ħażna tal- ħadid tal- pazjent, li tinkludi s- saturazzjoni ta ’ transferrin u serum ferritin, għandha tiġi evalwata.
Transferrin saturation should be at least 20%, and ct
Is- saturazzjoni ta ’ transferrin għandha tkun mill - inqas 20%, u dik ta ’ ferritin għandha tkun mill- inqas 100 ng/ ml.
ferritin should be at least 100 ng/ ml.
Jekk is- saturazzjoni ta ’ transferrin il
If transferrin saturation falls below 20%, or if ferritin falls below 100 ng/ ml, iron should be administered.
taqa ’ taħt 20%, jew jekk ferritin jaqa ’ taħt 100 ng/ ml, għandu jingħata l- ħadid.
Virtually all patients will eventually require supplemental iron du
Eventwalment kważi l - al
to increase or maintain transferrin saturation and ferritin to levels that will adequately support erythropoiesis stimulated by Dynepo. ro
pazjenti kollha ser ikunu jeħtieġu suppliment tal- ħadid biex iżidu jew iżommu s- saturazzjoni ta ’ transferrin u ferritin għal livelli li jissapportjaw b’ mod adegwat l- erythropoiesis stimulata minn in
Anaemia in epoetin-resistant or hyporesponsive patients with failure to respond to 20,000 IU/ week should be investigated, including referral to a haematologist. lp
L- anemija f’ pazjenti li huma reżistenti jew iporisponsivi għal epoetin u ma jirrispondux għal 20, 000 iċ
In the iron-replete patient with an inadequate response to Dynepo therapy, the following conditions a
Dan għandu jinkludi li jiġu riferuti għand ematoloġista. ed
should be evaluated and treated, if appropriated: in
F’ pazjenti li jkollhom ħadid biżżejjed iżda li jkollhom rispons inadegwat għat- terapija b’ Dynepo, il - kundizzjonijiet li ġejjin għandhom ikunu evalwati u kkurati, jekk ikun xieraq: m
• Infection/ inflammation ic
• Infezzjoni/ infjammazzjoni • Telf moħbi ta ’ demm t
• Occult blood loss • Hyperparathyroidism/ Osteitis fibrosa cystica ed
• Iperparatirojdiżmu/ Osteitis fibrosa cystica ot
• Aluminium intoxication • Haemoglobinopathies such as thalassaemia or sickle cell anaemia M
• Intossikazzjoni ta ’ l- aluminju • od
• Vitamin deficiencies, i. e., folic acid or vitamin B12 deficiencies • Haemolysis • Malignant diseases including multiple myeloma and myelodysplastic syndrome • Malnutrition
Emoglobinopatiji bħal talessimja jew sickle cell anaemia • Defiċjenzi tal- vitamini, i. e., defiċjenzi tal- folic acid jew ta ’ vitamina B12 • Emolisi Pr
28 The haemoglobin level should be determined once a week until it has stabilised in the suggested target range and the maintenance dose has been established.
28 mira.
Other:
Oħrajn Għalkemm ma kinux osservati b’ Dynepo, minħabba li reazzjonijiet anafilattojdi jistgħu jseħħu b’ erythropoietin, hu rrakkomandat li l- ewwel doża tingħata taħt superviżjoni medika.
ed The use of Dynepo in nephrosclerotic patients not yet undergoing dialysis should be defined individually, as a possible acceleration of progression of renal failure cannot be ruled out with certainty.
t za individwalment, għax il- possibbiltà ta ’ l- aċċelerazzjoni tal- progressjoni tal- kollass tal- kliewi ma tistax tiġi eskluża b’ ċertezza.
is or During haemodialysis, patients treated with Dynepo may require increased anticoagulation treatment to prevent clotting of the arterio-venous shunt.
riz Matul l- emodijaliżi, il- pazjenti kkurati b’ Dynepo jista ’ jkollhom bżonn ta ’ żieda fil- kura kontra l - koagulazzjoni biex jiġi evitat it- tagħqid tad- demm tas- shunt arterjo- venuża.
th Misuse of epoetin by healthy persons may lead to an excessive increase in haemoglobin and haematocrit.
to L- użu ħażin ta ’ epoetin minn persuni b’ saħħithom jista ’ jwassal għal żieda eċċessiva fl- emoglobina u fl -
au This may be associated with life-threatening cardiovascular complications.
Dan jista ’ jkun assoċjat ma ’ komplikazzjonijiet kardjovaskulari ta ’ periklu għall- ħajja.
er 4.5 Interaction with other medicinal products and other forms of interaction ng No interaction studies have been performed. lo No interactions have been reported during treatment with Dynepo in the course of clinical trials. no
x du L- ebda studji ma saru fuq interazzjoni ta` mediċini oħra ma` Dynepo
4.6 Pregnancy and lactation
L- ebda interazzjonijiet ma kienu rrappurtati matul il- kura b’ Dynepo sakemm damu jsiru l- provi ħa kliniċi. ’ g 4. 6 Tqala u treddigħ im
The ct
Studji fuq il- bhejjem rigward l- effetti fuq it- tqala (ara sezzjoni 5. 3) m’ humiex suffiċjenti.
potential risk for humans is unknown.
Ir - riskju potenzjali għall- bnedmin mhuwiex magħruf.
In case of its use during pregnancy, concomitant iron substitution should be considered in the du
F’ każ ta ’ l- użu tagħha matul it- tqala, l- użu fl- istess ħin ta ’ il
mother.
sostituzzjoni tal- ħadid għandha tiġi kkunsidrata fl- omm.
Since many compounds ro
Minħabba li ħafna al
are excreted in human milk, caution should be advised when Dynepo is administered to breast-feeding women. lp
komposti jitneħħew fil- ħalib uman, għandha tingħata attenzjoni meta Dynepo jingħata li nisa li jkunu in
4.7 Effects on ability to drive and use machines a in
4. 7 Effetti fuq is- sewqan u l- użu ta ’ magni ed
Dynepo has no or negligible influence on the ability to drive and use machines. ic
Dynepo m’ għandu l- ebda influwenza, jew influwenza negliġibbli, fuq il- ħila biex issuq jew tħaddem magni. m
The most M
Esperjenza klinika od
30 During the clinical trials, there were no indications of development of neutralising antibodies to epoetin delta in humans based on the clinical response.
30 jinnewtralizzaw, għal epoetin delta fil- bnedmin, ibbażati fuq ir- rispons kliniku.
31 5.3 Preclinical safety data
31 hi bejn 26% u 36%.
When given subcutaneously, the site of injection should be rotated with each administration.
32 Meta jingħata taħt il- ġilda, is- sit ta ’ injezzjoni għandu jinbidel ma ’ kull għotja.
32 The syringe is pre-assembled with a needle safety guard to prevent needle stick injury.
Is- siringa hi mmuntata minn qabel bi protezzjoni għas- sigurtà tal- labra biex jiġi evitat korriment ikkawżat mit- tingiż tal- labra.
or EU/ 1/ 02/ 211/ 004
EU/ 1/ 02/ 211/ 004 ’ g
Dynepo 5,000 IU/ 0.5 ml solution for injection in a pre-filled syringe.
Dynepo 5, 000 IU/ 0. 5 ml soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest.
Pre-filled syringe containing 5,000 IU per 0.5 ml dose (10,000 IU/ ml) of the active substance epoetin delta.
Siringa mimlija għal- lest li fiha 5, 000 IU f’ kull doża ta ’ 0. 5 ml (10, 000 IU/ ml) tas- sustanza attiva epoetin delta.
is Solution for injection in a pre-filled syringe.
to Soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest.
or Clear, colourless and waterlike.
Soluzzjoni ċara, bla kulur u qisha ilma.
Dynepo is indicated for the treatment of symptomatic anaemia associated with chronic renal failure(CRF) in adult patients.
Dynepo hu indikat għall- kura ta ’ anemija sintomatika assoċjata ma ’ insuffiċjenza renali kronika (CRF) ħa f’ pazjenti adulti.
Starting dose is 50 IU/ kg three times a week if administered intravenously.
34 Immaniġġjar tad- Doża Id- doża tal- bidu hi ta ’ 50 IU/ kg tliet darbiet f’ ġimgħa jekk tingħata ġol- vina.
Because of the time required for erythropoiesis, an interval of approximately 4 weeks may occur between the time of a dose adjustment (initiation, increase, decrease or discontinuation) and a significant change in haemoglobin.
Minħabba ż- żmien meħtieġ għal erythropoiesis, intervall ta ’ madwar 4 ġimgħat jista ’ jgħaddi bejn meta jsir aġġustament tad- doża (il- bidu, iż- żieda, it- tnaqqis jew it- twaqqif) u tibdil
In consequence, dose adjustment should not be made more frequently than once a month, unless clinically indicated.
Bħala konsegwenza, l- aġġustament tad- doża m’ għandux isir iktar minn darba f’ xahar, ħlief jekk klinikament indikat.
ed Dose should be decreased by 25% – 50% or treatment temporarily withdrawn and then re-introduced
riz Id- doża għandha titnaqqas b’ 25% – 50% jew il- kura titwaqqaf temporanjament u mbagħad tinbeda mill- ġdid b’ dożaġġ iktar baxx jekk:
Subcutaneous self administration may lo be used after training by a medical professional.
L- għoti ta ’ injezzjoni taħt il- ġilda mill- pazjent stess, ħa jista ’ jsir wara taħriġ minn persuna medika professjonali.
The required weekly dose of Dynepo is lower when Dynepo is administered subcutaneously compared no
Id- doża meħtieġa ta ’ kull ġimgħa ta ’ Dynepo hi iktar baxxa meta Dynepo jingħata taħt il- ġilda meta ’ g
to intravenously. ct
mqabbel ma ’ l- għoti ġol- vina. im
Due to limited experience, the safety and efficacy of Dynepo could not be assessed in patients with impaired liver function.
Minħabba esperjenza limitata, l- effikaċja u s- sigurtà ta ’ Dynepo ma jistgħux ikunu evalwati f’ pazjenti t
M
b’ indeboliment fil- funzjoni tal- fwied. ot od
35 In clinical trials, an increased risk of death and serious cardiovascular events was observed when erythropoiesis stimulating agents (ESAs) were administered to target a haemoglobin of greater than 12 g/ dL (7.5 mmol/ l).
35 ngħataw mediċini li jistimulaw l- erythropoiesis (ESAs) biex jinkiseb livell ta ’ emoglobina ta ’ iktar minn 12 g/ dL (7. 5 mmol/ l).
th Increases in blood pressure may require treatment with anti-hypertensive medicines or dosing increase of
aw Attenzjoni partikulari għandha tingħata lill- uġigħ ta ’ ras qisu emigranja, li jiġi għall- għarrieda, għax dan ikun possibbilment sinjal ta ’ twissija.
• Occult blood loss Hyperparathyroidism/ Osteitis fibrosa cystica ed
• Iperparatirojdiżmu/ Osteitis fibrosa cystica ot
• • Aluminium intoxication • Haemoglobinopathies such as thalassaemia or sickle cell anaemia M
• Intossikazzjoni ta ’ l- aluminju • od
36 should also be determined once weekly until it has stabilised in the target range.
36 mira.
During the clinical trials, there were no indications of development of neutralising antibodies to epoetin delta in humans based on the clinical response.
Matul il- provi kliniċi, ma kien hemm l- ebda indikazzjonijiet ta ’ żvilupp ta ’ antikorpi li
38 When administration is halted, the eyrthropoietic parameters return toward baseline levels within the recovery period of 1-3 months.
38 jinnewtralizzaw, għal epoetin delta fil- bnedmin, ibbażati fuq ir- rispons kliniku.
Erythropoietin is a growth factor that primarily stimulates red cell production.
Ir- riċetturi ta ’ erythropoietin jistgħu jkunu espressi fuq il- wiċċ ta ’ varjetà ta ’ ċelluli tat- tumur
Erythropoietin receptors may be expressed on the surface of a variety of tumour cells.
Is- sopravivenza u l- progressjoni tat- tumur kienu eżaminati f’ ħames studji kbar ikkontrollati ta ’ epoetin
ed Survival and tumour progression have been examined in five large controlled studies of epoetin alfa, beta and darbepoetin alfa involving a total of 2,833 patients, of which four were double-blind placebo- controlled studies and one was an open-label study.
riz alfa, beta u darbepoetin alfa, li kienu jinvolvu total ta ’ 2, 833 pazjent, li erba ’ minnhom kienu studji double- blind u kkontrollati bil- plaċebo, u wieħed kien studju open- label.
is being treated with chemotherapy.
to jinkludu pazjenti li kienu qed ikunu kkurati bil- kimoterapija.
or in the remaining three studies it was 12-14 g/ dL.
aw istudju open- label ma kien hemm l- ebda differenza fis- sopravivenza totali bejn pazjenti kkurati b’ erythropoietin uman rikombinanti u l- kontrolli.
au mortality in patients who have anaemia associated with various common cancers who received recombinant human erythropoietin compared to controls.
du erythropoietin uman rikombinanti, meta mqabbla mal- kontrolli.
Overall survival outcome in the trials could
Ir- riżultat totali tas- sopravivenza fil - provi ma setax ikun spjegat b’ mod sodisfaċenti mid- differenzi fl- inċidenza ta ’ trombożi u ħa kumplikazzjonijiet marbuta bejn dawk il- pazjenti li ngħataw erythropoietin uman rikombinanti u dawk fil- grupp tal- kontroll. ’ g
er not be satisfactorily explained by differences in the incidence of thrombosis and related complications between those given recombinant human erythropoietin and those in the control group. ng A systematic review has also been performed involving more than 9000 cancer patients participating lo in 57 clinical trials.
Saret ukoll evalwazzjoni sistematika li kienet tinvolvi iktar minn 9000 pazjent bil- kanċer li kienu qed im
of thromboembolic events (RR 1.67, 95% CI:
Żieda relattiva fir- riskju ta ’ avvenimenti tromboemboliċi (RR 1. 67, 95% CI:
There is therefore consistent evidence to suggest that there may be significant harm to patients with cancer who are treated with recombinant ct
Għalhekk, hemm evidenza konsistenti li tissuġġerixxi li jista ’ jkun hemm ħsara sinifikanti lil pazjenti bil- kanċer li al
The extent to which these outcomes might apply to the administration of recombinant human erythropoietin to patients with cancer, treated with chemotherapy to achieve du
Il- grad sa fejn dawn riżultati jistgħu japplikaw għall- għoti ta ’ erythropoietin uman rikombinanti lil pazjenti bil- kanċer, ikkurati bil- kimoterapija biex in
The extent to which the outcomes observed in the clinical studies lp
Ir- riżultati dwar is - sopravivenza u l- progressjoni tat- tumur f’ pazjenti bil- kanċer li kienu qed jiġu kkurati b’ Dynepo għall - ed
discussed above may apply to this patient population is unclear, specifically considering that the dosages administered in the renal indication are lower than in the cancer indication.. a in
Il- grad sa fejn ir- riżultati osservati fl- istudji kliniċi diskussi hawn fuq jistgħu japplikaw għal din il- popolazzjoni ta ’ pazjenti, m
5.2 Pharmacokinetic properties ic
5. 2 Tagħrif farmakokinetiku ot od
The pharmacokinetics of erythropoietin following administration of epoetin delta has been examined ed
Il- farmakokinetiċi ta ’ erythropoietin wara l- għoti ta ’ epoetin delta kienu eżaminati kemm f’ voluntiera b’ saħħithom u kemm f’ pazjenti b’ kollass kroniku tal- kliewi.
Following intravenous doses, volume of distribution approximates total blood volume and ranges from 0.063 to 0.097 l/ kg.
Wara dożi ġol- vina, il- volum tad - distribuzzjoni joqrob dak tal- volum totali tad- demm u jvarja minn 0. 063 sa 0. 097 l/ kg.
The M
Il- half- life ta ’ l - Pr
elimination half-life ranges from 4.7 to 13.2 hours in patients.
eliminazzjoni tvarja minn 4. 7 sa 13. 2 sigħat fil- pazjenti.
39 5.3 Preclinical safety data
39 hi bejn 26% u 36%.