qanastek/EMEA-V3 huggingface dataset:
In patients with chronic renal failure, maintenance haemoglobin concentration should not exceed the upper limit of the target haemoglobin concentration recommended in section 4.2.
Biex tkun żgurata l- formazzjoni effettiva taċ- ċelluli tad- demm ħomor, għandu jkun evalwat l- istat tal - ħadid għal kull pazjent qabel u waqt il- kura, u jista ’ jkun hemm bżonn ta ’ terapija supplimentari bil - ħadid li għandha tingħata skond il- linji gwida tat- terapija.
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).
Togħbija severa ta ’ aluminju minħabba kura ta ’ insuffiċjenza tal- kliewi tista ’ tnaqqas l- effikaċja ta ’ NeoRecormon.
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.
L- indikazzjoni għall- kura b’ NeoRecormon ta ’ pazjenti nefrosklerotiċi li għadhom ma bdewx id- dijalisi, għandha tiġi ddefinita ndividwalment, għax l- possibiltà ta ’ aċċelerazzjoni ta ’ progressjoni ta ’ insuffiċjenza renali ma tistax titwarrab b’ ċertezza.
In premature infants there may be a slight rise in platelet counts, particularly up to day 12 - 14 of life, therefore platelets should be monitored regularly.
Aplasja pura taċ- ċelluli ħomor ikkawżata minn antikorpi newtralizzanti kontra l- eritropoetin, kienet irrappurtata f’ assoċjazzjoni ma ’ terapija b’ eritropoetin, inkluż NeoRecormon.
Effect on tumour growth Epoetins are growth factors that primarily stimulate red blood cell production.
Dawn iż- żidiet fil- pressjoni tad- demm jistgħu jiġu kkurati b’ prodotti mediċinali.
Erythropoietin receptors may be expressed on the surface of a variety of tumour cells.
Jekk iż- żjieda fil - pressjoni tad- demm ma tistax tiġi kkontrollata minn terapija b’ mediċini, interuzzjoni għal ftit taż - żmien tat- terapija b’ NeoRecorman hija rakkomandata.
As with all growth factors, there is a concern that epoetins could stimulate the growth of tumours.
Speċjalment fil- bidu tat- terapija, hija rakkomandata sorveljanza regolari tal- pressjoni tad- demm, inkluż bejn dijalisi u ieħor.
In several controlled studies, epoetins have not been shown to improve overall survival or decrease the risk of tumour progression in patients with anaemia associated with cancer.
Tista ’ sseħħ kriżi ipertensiva b’ sintomi jixbħu lil enċefalopatija li tinħtieġ attenzjoni mmedjata ta ’ tabib u kura medika intensiva.
In controlled clinical studies, use of NeoRecormon and other erythropoiesis-stimulating agents (ESAs) have shown:
Għandha tingħata attenzjoni speċjali lill- uġigħ ta ’ ras li jagħti f’ daqqa, itektek u jixbaħ lill- emikranja, għax jista ’ jkun sinjal possibbli ta ’ twissija.
147
Din tonqos tul il- kors tat- terapija.
- shortened time to tumour progression in patients with advanced head and neck cancer receiving
Huwa rakkomandat li l- għadd ta ’ plejtlits ikun issorveljat regolarment matul l- ewwel 8 ġimgħat ta ’ terapija.
radiation therapy when administered to target a haemoglobin of greater than 14 g/ dl (8.7 mmol/ l),
Fi provi kliniċi, kienet osservata żjieda fir- riskju ta ’ mewt u ta ’ episodji kardjovaskulari serji meta sustanzi li jistimolaw l- eritropoesi (ESAs) ingħataw biex tintlaħaq emoglobina ta ’ aktar minn 12 g/ dl (7. 5 mmol/ l).
- shortened overall survival and increased deaths attributed to disease progression at 4 months in
152 Provi kliniċi kkontrollati ma wrewx benefiċċji sinifikanti attribwiti lill- għoti ta ’ epoetins meta l - konċentrazzjoni ta ’ l- emoglobina tiżdied ’ il fuq mil- livell neċessarju għall- kontroll ta ’ sintomi ta ’ l - anemija u biex tiġi evitata trasfużjoni tad- demm.
patients with metastatic breast cancer receiving chemotherapy when administered to target a haemoglobin of 12-14 g/ dl (7.5-8.7 mmol/ l),
Fi trabi prematuri, jista ’ jkun hemm żjieda żgħira fl- għadd ta ’ plejtlits, partikolarment sa 12- 14- il ġurnata ta ’ ħajja, għalhekk il- plejtlits għandhom jiġu sorveljati regolarment.
- increased risk of death when administered to target a haemoglobin of 12 g/ dl (7.5 mmol/ l) in
Effett fuq it- tkabbir tat- tumur Epoetins huma fatturi tat- tkabbir li primarjament jistimolaw il- produzzjoni ta ’ ċelluli ħomor tad- demm.
patients with active malignant disease receiving neither chemotherapy nor radiation therapy.
Riċetturi għall- eritropoetin jistgħu jinstabu fuq il- wiċċ ta ’ diversi ċelluli tat- tumur.
ESAs are not indicated for use in this patient population.
Bħal bil- fatturi tat - tkabbir kollha, hemm il- biża li epoetins jistgħu jistimolaw it- tkabbir ta ’ tumuri.
In view of the above, in some clinical situations blood transfusion should be the preferred treatment for the management of anaemia in patients with cancer.
- ħin imqassar sal- progressjoni tat- tumur f’ pazjenti b’ kanċer avvanzat fir- ras u fl- għonq li qed
Factors that should be considered in this assessment should include the type of tumour and its stage; the degree of anaemia; life- expectancy; the environment in which the patient is being treated; and patient preference (see section 5.1)
jirċievu terapija ta ’ radjazzjoni meta mogħti biex tintlaħaq emoglobina ta ’ aktar minn 14 g/ dl (8. 7 mmol/ l),
There may be an increase in blood pressure which can be treated with drugs.
- sopravivenza globali mqassra u żjieda fl- imwiet attribwiti lill- progressjoni tal- marda wara 4
It is therefore recommended to monitor blood pressure, in particular in the initial treatment phase in cancer patients.
xhur f’ pazjenti b’ kanċer metastatiku tas- sider li qed jirċievu kimoterapija meta mogħti biex tintlaħaq emoglobina ta ’ 12- 14 g/ dl (7. 5- 8. 7 mmol/ l),
Platelet counts and haemoglobin level should also be monitored at regular intervals in cancer patients.
- żjieda fir- riskju ta ’ mewt meta mogħti biex tintlaħaq emoglobina ta ’ 12 g/ dl (7. 5 mmol/ l)
In patients in an autologous blood predonation programme there may be an increase in platelet count, mostly within the normal range.
f’ pazjenti b’ marda malinna attiva li mhux qed jirċievu kimoterapija jew terapija ta ’ radjazzjoni.
Therefore, it is recommended that the platelet count be determined at least once a week in these patients.
ESAs mhumiex indikati għall- użu f’ din il- popolazzjoni ta ’ pazjenti.
If there is an increase in platelets of more than 150 x 109/ l or if platelets rise above the normal range, treatment with NeoRecormon should be discontinued.
Minħabba l- punti msemmijin fuq, f’ xi sitwazzjonijiet kliniċi trasfużjonijiet tad- demm għandhom ikunu l- kura ppreferita għall- immanniġġjar ta ’ anemija f’ pazjenti bil- kanċer.
In chronic renal failure patients an increase in heparin dose during haemodialysis is frequently required during the course of therapy with NeoRecormon as a result of the increased packed cell volume.
Jista ’ jkun hemm żjieda fil- pressjoni tad- demm li tista ’ tiġi kkurata b’ mediċini.
Occlusion of the dialysis system is possible if heparinisation is not optimum.
Għalhekk huwa rakkomandat li tiġi sorveljata l- pressjoni tad- demm, speċjalment fil- fażi tal- bidu tal- kura f’ pazjenti bil - kanċer.
Early shunt revision and thrombosis prophylaxis by administration of acetylsalicylic acid, for example, should be considered in chronic renal failure patients at risk of shunt thrombosis.
L- għadd ta ’ plejtlits u l- livell ta ’ emoglobina ukoll għandhom jiġu sorveljati f’ intervalli regolari f’ pazjenti bil- kanċer.
Serum potassium and phosphate levels should be monitored regularly during therapy with NeoRecormon.
Jista ’ jkun hemm żjieda fl- għadd ta ’ plejtlits li fil- biċċa l- kbira tibqa ’ f’ limiti normali, f’ pazjenti li jkunu qegħdin fi programm fejn jingħatalhom id- demm tagħhom stess.
Potassium elevation has been reported in a few uraemic patients receiving NeoRecormon, though causality has not been established.
Għalhekk huwa rakkomandat li f’ dawn il- pazjenti l- għadd ta ’ plejtlits jiġi determinat mill- inqas darba fil- ġimgħa.
If an elevated or rising potassium level is observed then consideration should be given to ceasing administration of NeoRecormon until the level has been corrected.
Jekk ikun hemm żjieda ikbar minn 150 x 109/ l jew jekk il- plejtlits jiżdiedu iktar mill- limitu normali, il- kura b’ NeoRecormon għandha titwaqqaf.
For use of NeoRecormon in an autologous predonation programme, the official guidelines on principles of blood donation must be considered, in particular:
Jekk il- heparinisation ma tkunx l- aħjar, jista ’ jkun hemm okklużjoni tal- magna tad- dijalisi.
- only patients with a PCV ≥ 33% (haemoglobin ≥ 11 g/ dl [6.83 mmol/ l]) should donate;
F’ pazjenti b’ insuffiċjenza kronika tal- kliewi li għandhom riskju ta ’ shunt thrombosis, għandu jiġi ikkunsidrat li ssir reviżjoni ta ’ shunts u lqugħ għat- trombożi billi jingħata acetylsalicylic acid, per eżempju.
- special care should be taken with patients below 50 kg weight;
Jekk ikun osservat livell ogħli ta ’ potassju
12% of the patient's estimated blood
153 jew li l- livell ikun qed jiżdied għandu jkun ikkunsidrat li jitwaqqaf NeoRecormon sakemm il- livell ikun irranġat.
Treatment should be reserved for patients in whom it is considered of particular importance to avoid homologous blood transfusion taking into consideration the risk/ benefit assessment for homologous transfusions.
Biex NeoRecormon jintuża fuq pazjenti li jkunu fi programm fejn jingħataw id- demm tagħhom stess, għandhom jiġu kkunsidrati l- linji gwida uffiċjali dwar il- prinċipji tad- donazzjoni tad- demm, partikolarment: jistgħu jagħtu d- demm biss pazjenti b’ PCV ≥ 33% (emoglobina ≥ 11 g/ dl [6. 83 mmol/ l];
Misuse by healthy persons may lead to an excessive increase in packed cell volume.
- kura speċjali trid tingħata lil pazjenti li jiżnu inqas minn 50 kg;
This may be associated with life-threatening complications of the cardiovascular system.
- il- volum meħud f’ darba m’ għandux jaqbeż bejn wieħed u ieħor it- 12% ta ’ dak li hu stmat li hu
NeoRecormon in pre-filled syringe contains up to 0.3 mg phenylalanine/ syringe as an excipient.
il- volum tad- demm tal- pazjent.
Therefore this should be taken into consideration in patients affected with severe forms of phenylketonuria.
Il- kura għandha tingħata biss lil pazjenti li għalihom huwa kkunsidrat importanti ħafna li tkun evitata trasfużjoni ta ’ demm omologu, b’ kunsiderazzjoni ta ’ valutazzjoni tar- riskji/ benefiċċji ta ’ trasfużjonijiet omologi.
148 This medicinal product contains less than 1 mmol sodium (23 mg) per syringe, i. e. essentially “ sodium-free”.
Dan jista ’ jkun assoċjat ma ’ kumplikazzjonijiet fis- sistema kardjovaskulari li joħolqu periklu ta ’ mewt.
4.5 Interaction with other medicinal products and other forms of interaction
NeoRecormon jista ’ jkun fih sa 0. 3 mg ta ’ phenylalanine/ kunjett bħala sustanza mhux attiva.
The clinical results obtained so far do not indicate any interaction of NeoRecormon with other medicinal products.
Dan il- prodott mediċinali fih inqas minn 1 mmol ta ’ sodju (23 mg) kull siringa, i. e. essenzjalment “ bla sodju ”.
4.6 Pregnancy and lactation
4. 5 Prodotti mediċinali oħra li ma jaqblux ma ’ dan il- prodott u affarijiet oħra li jistgħu jibdlu l- effett farmaċewtiku tal- prodott
For epoetin beta no clinical data on exposed pregnancies are available.
Ir- riżultati kliniċi miksubin s’ issa ma jurux li hemm interazzjoni ta ’ NeoRecormon ma ’ prodotti mediċinali oħra.
Caution should be exercised when prescribing to pregnant women.
Esperimenti fuq l- annimali wrew li epoetin beta ma jżidx il- mijelotossiċità ta ’ prodotti mediċinali ċitostatiċi bħal etoposide, cisplatin, cyclophosphamide, u fluorouracil.
4.7 Effects on ability to drive and use machines
4. 6 Tqala u treddigħ
NeoRecormon has no influence on the ability to drive and use machines.
Għall- epoetin beta m’ hemmx tagħrif kliniku dwar l- użu waqt it- tqala.
Based on results from clinical trials including 1725 patients approximately 8% of patients treated with NeoRecormon are expected to experience adverse reactions.
NeoRecormon m’ għandu l- ebda effett fuq il- ħila biex issuq u tħaddem magni.
Shunt thromboses may occur, especially in patients who have a tendency to hypotension or whose arteriovenous fistulae exhibit complications (e. g. stenoses, aneurisms), see section 4.4.
154 Tista ’ sseħħ shunt thrombosis speċjalment f’ pazjenti li għandhom tendenza għal ipotensjoni jew dawk li għandhom kumplikazzjonijiet fil- fistulae arterjovenużi (eż. stenożi, anewriżmi), ara sezzjoni 4. 4.
Hypertensive crisis Hypertension
Kriżi ipertensiva
Uncommon (> 0.1% ,< 1%) Common (> 1% ,< 10%)
Mhux komuni (> 0. 1%, < 1%)
Headache Shunt thrombosis Thrombocytosis
Pressjoni għolja
Common (> 1% ,< 10%) Rare (> 0.01% ,< 0.1%) Very rare (< 0.01%)
Komuni (> 1%, < 10%)
149
Disturbi fis- sistema nervuża
- Patients with cancer
Uġigħ ta ’ ras
Epoetin beta treatment-related headache and hypertension which can be treated with drugs are common (> 1%, < 10%) (see section 4.4).
Komuni (> 1%, < 10%)
In some patients, a fall in serum iron parameters is observed (see section 4.4).
Rari (> 0. 01%, < 0. 1%) Rari ħafna (< 0. 01%)
Clinical studies have shown a higher frequency of thromboembolic events in cancer patients treated with NeoRecormon compared to untreated controls or placebo.
Uġigħ ta ’ ras u pressjoni għolja li tista ’ tiġi kkontrollata b’ mediċini, relatati ma ’ kura b’ epoetin beta, huma komuni (> 1%, < 10%) (ara sezzjoni 4. 4).
In patients treated with NeoRecormon, this incidence is 7% compared to 4% in controls; this is not associated with any increase in thromboembolic mortality compared with controls.
F’ xi pazjenti, huwa osservat tnaqqis fil- parametri ta ’ ħadid fis- serum (ara sezzjoni 4. 4).
The incidences of undesirable effects in clinical trials, considered related to treatment with NeoRecoromon are shown in the table below.
Studji kliniċi urew frekwenza ogħla ta ’ avvenimenti trombo- embolitiċi f’ pazjenti bil- kanċer ikkurati b’ NeoRecormon meta mqabbla ma ’ dawk il- kontrolli mhux ikkurati jew ma ’ plaċebo.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
F’ pazjenti kkurati b’ NeoRecormon, din l- inċidenza hija ta ’ 7% meta mqabbla ma ’ 4% fil- kontrolli; din mhix assoċjata ma ’ żjieda fil- mortalità b’ kawża trombo- embolitika meta mqabbla mal- kontrolli.
System Organ Class
L- effetti li huma l- aktar serji għandhom jitniżżlu l- ewwel, segwiti minn dawk anqas serji.
The incidences of undesirable effects in clinical trials, considered related to treatment with NeoRecoromon are shown in the table below.
155 L- inċidenza ta ’ effetti mhux mixtieqa fi studji kliniċi, kkunsidrati relatati ma ’ kura b’ NeoRecoromon huma mniżżla fit- tabella taħt.
Survival and tumour progression have been examined in five large controlled studies involving a total of 2833 patients, of which four were double-blind placebo-controlled studies and one was an open- label study.
Is- sopravivenza u l - progressjoni tat- tumur ġew eżaminati f’ ħames studji kbar ikkontrollati li kienu jinvolvu total ta ’ 2833
The target haemoglobin concentration in two studies was > 13 g/ dl; in the remaining three studies it was 12- 14 g/ dl.
Il - konċentrazzjoni mmirata ta ’ l- emoglobina fi tnejn mill- istudji kienet > 13 g/ dl; fit- tliet studji li jibqa ’ din kienet 12- 14 g/ dl.
In the open-label study there was no difference in overall survival between patients treated with recombinant human erythropoietin and controls.
Fl- istudju open- label ma kien hemm l- ebda differenza fis- sopravivenza globali bejn pazjenti kkurati b’ eritropoetin rikombinanti uman u l- kontrolli.
In the four placebo-controlled studies the hazard ratios for overall survival ranged between 1.25 and 2.47 in favour of controls.
Fl- erba ’ studji kkontrollati bil - plaċebo il- proporzjon ta ’ periklu għas- sopravivenza globali varjaw bejn 1. 25 u 2. 47 favur il- kontrolli.
Overall survival outcome in the trials could 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.
Ir- riżultat tas- sopravivenza globali fil- provi ma setgħax jiġi spjegat b’ mod sodisfaċenti mid- differenza fl- inċidenza ta ’ trombożi u mill - kumplikazzjonijiet relatati bejn dawk li ngħataw eritropoetin rikombinanti uman u dawk fil- grupp ta ’ kontroll.
151 haemoglobin concentrations less than 13 g/ dl, is unclear because few patients with these characteristics were included in the data reviewed.
Kemm dawn ir- riżultati jistgħu japplikaw għall- għoti ta ’ eritropoetin rikombinanti umana lill- pazjenti bil- kanċer, ikkurati b’ kimoterapija biex jilħqu konċentrazzjonijiet ta ’ l- emoglobina inqas minn 13 g/ dl, mhux ċar minħabba li ftit pazjenti b’ dawn il - karatteristiċi kienu inklużi fl- analiżi tat- tagħrif.
152 6.4 Special precautions for storage
6. 4 Prekawzjonijiet speċjali għall- ħażna
For the purpose of ambulatory use, the patient may remove the product from the refrigerator and store it at room temperature (not above 25°C) for one single period of up to 3 days.
Għall- skop ta ’ użu ambulatorju, il- pazjent jista ’ jneħħi l- prodott mill- friġġ u jżommu f’ temperatura ambjentali (mhux aktar minn 25 °C), għall- perjodu wieħed ta ’ mhux aktar minn tlett ijiem
0.6 ml of solution in pre-filled syringe (Type I glass) with a tip cap and a plunger stopper (teflonised rubber) with a needle 27G1/ 2.
0. 6 ml ta ’ soluzzjoni f’ siringa mimlija għal lest (ħġieġ Tip I u b’ għatu tat- tarf u tap tal- planġer (materjal tal- lasktuteflonizzata), b’ labra 27G1/ 2.
This medicinal product is for single use only.
158 Dan il- prodott mediċinali huwa għall- użu ta ’ darba biss.
EU/ 1/ 97/ 031/ 035 - 036
NUMRU( I) TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ EU/ 1/ 97/ 031/ 035 - 036
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/.
DATA TA ’ META ĠIET RIVEDUTA L- KITBA Informazzjoni dettaljata dwar dan il- prodott tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il - Mediċini (EMEA) http: // www. emea. europa. eu /
NeoRecormon 20,000 IU solution for injection in pre-filled syringe
NeoRecormon 20, 000 IU soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest
One pre-filled syringe with 0.6 ml solution for injection contains 20,000 international units (IU) corresponding to 166 micrograms epoetin beta* (recombinant human erythropoietin).
Siringa waħda mimlija għal- lest b’ 0. 6 ml soluzzjoni għall- injezzjoni li fiha 20, 000 unità internazzjonali (IU) li jikkorrespondu għal 166 mikrogrammi epoetin beta * (eritropoetin rikombinanti uman).
One ml solution for injection contains 33,333 IU epoetin beta.
Kull ml ta ’ soluzzjoni għall- injezzjoni fiha 33, 333 IU epoetin beta.
Treatment of symptomatic anaemia in adult and paediatric chronic renal failure patients:
160 Kura ta ’ anemija sintomatika f’ pazjenti adulti u pedjatriċi b’ insuffiċjenza kronika tal- kliewi:
155 haemoglobin to not greater than 12 g/ dl (7.5 mmol/ l).
NeoRecormon għandu jingħata minn taħt il- ġilda jew minn ġol- vini sabiex iżid l- emoglobina sa mhux aktar minn 12 g/ dl (7. 5 mmol/ l).
Results of clinical studies in children have shown that, on average, the younger the patients, the higher the NeoRecormon doses required.
161 Riżultati kliniċi fit- tfal urew li, ġeneralment iktar ma jkunu żgħar il- pazjenti iktar ikun hemm bżonn ta ’ dożi ta ’ NeoRecormon għoljin.
156 Prevention of anaemia of prematurity:
Prevenzjoni ta ’ anemija ta ’ prematurità:
Patients should be monitored closely to ensure that the lowest approved dose of NeoRecormon is used to provide adequate control of the symptoms of anaemia.
162 Il- pazjenti għandhom jiġu sorveljati mill- viċin sabiex jiġi assigurat li tiġi wżata l- inqas doża approvata ta ’ NeoRecormon biex jiġi pprovdut kontoll adegwat tas- sintomi ta ’ l- anemija.
157 The dosage must be determined by the surgical team individually for each patient as a function of the required amount of pre-donated blood and the endogenous red cell reserve:
Id- dożaġġ għandu jkun iddeterminat għal kull pazjent individwali mill- iskwadra kirurġika bħala funzjoni ta ’ l- ammont meħtieġ ta ’ demm mogħti minn qabel u r- riserva ta ’ ċelluli ħomor endoġeni:
The indication for treatment with NeoRecormon and, if given, the single dose should be determined from the required amount of pre-donated blood and the endogenous red cell reserve according to the following graphs.
Ü
Female patients
s.
Male patients
Ü /
Required amount of pre-donated blood [units]
Tg
Required amount of pre-donated blood [units]
n
Endogenous red cell reserve [ml]
8 Ü/ k
Endogenous red cell reserve [ml]
ec
The single dose thus determined is administered twice weekly over 4 weeks.
o
4.3 Contraindications
30 Ü/ k rmo
Hypersensitivity to the active substance or any of the excipients.
s.
Poorly controlled hypertension.
0 T co 5
In the indication "increasing the yield of autologous blood": myocardial infarction or stroke in the month preceding treatment, unstable angina pectoris, increased risk of deep venous thrombosis such as history of venous thromboembolic disease.
i. v
158 4.4 Special warnings and precautions for use
0T
NeoRecormon should be used with caution in the presence of refractory anaemia with excess blasts in transformation, epilepsy, thrombocytosis, and chronic liver failure.
s.
In order to ensure effective erythropoiesis, iron status should be evaluated for all patients prior to and during treatment and supplementary iron therapy may be necessary and conducted in accordance with therapeutic guidelines.
c:
Severe aluminium overload due to treatment of renal failure may compromise the effectiveness of NeoRecormon.
eo
The indication for treatment with NeoRecormon of 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.
R
Pure red cell aplasia caused by neutralising anti-erythropoietin antibodies has been reported in association with erythropoietin therapy, including NeoRecormon.
40
In chronic renal failure patients an increase in blood pressure or aggravation of existing hypertension, especially in cases of rapid PCV increase can occur.
/ kg
It is recommended that the platelet count be monitored regularly during the first 8 weeks of therapy.
: 8
In patients with chronic renal failure, maintenance haemoglobin concentration should not exceed the upper limit of the target haemoglobin concentration recommended in section 4.2.
:
In premature infants there may be a slight rise in platelet counts, particularly up to day 12 - 14 of life, therefore platelets should be monitored regularly.
Ü
Effect on tumour growth Epoetins are growth factors that primarily stimulate red blood cell production.
ed
159
Üs
- shortened time to tumour progression in patients with advanced head and neck cancer receiving
00 / kg d 0
radiation therapy when administered to target a haemoglobin of greater than 14 g/ dl (8.7 mmol/ l),
i
- shortened overall survival and increased deaths attributed to disease progression at 4 months in
4 TÜ ie e
patients with metastatic breast cancer receiving chemotherapy when administered to target a haemoglobin of 12-14 g/ dl (7.5-8.7 mmol/ l),
M
- increased risk of death when administered to target a haemoglobin of 12 g/ dl (7.5 mmol/ l) in
Riserva ta ’ ċelluli ħomor endoġeni [ml]
ESAs are not indicated for use in this patient population.
Riserva ta ’ ċelluli ħomor endoġeni [ml]
In view of the above, in some clinical situations blood transfusion should be the preferred treatment for the management of anaemia in patients with cancer.
Id- doża waħdanija ddeterminata b’ dan il- mod tingħata darbtejn fil- ġimgħa fuq medda ta ’ 4 ġimgħat.
The decision to administer recombinant erythropoietins should be based on a benefit-risk assessment with the participation of the individual patient, which should take into account the specific clinical context.
L- ogħla doża m’ għandhiex tkun iktar minn 1600 IU/ kg piż tal- ġisem kull ġimgħa għall - amministrazzjoni ġol- vini jew 1200 IU/ kg kull ġimgħa għall- amministrazzjoni minn taħt il- ġilda.
There may be an increase in blood pressure which can be treated with drugs.
163 4. 3 Kontra- indikazzjonijiet
It is therefore recommended to monitor blood pressure, in particular in the initial treatment phase in cancer patients.
Sensittività eċċessiva għas- sustanza attiva jew għal xi sustanzi mhux attivi.
Platelet counts and haemoglobin level should also be monitored at regular intervals in cancer patients.
Pressjoni għolja mhux kontrollata tajjeb
Therefore, it is recommended that the platelet count be determined at least once a week in these patients.
Meta ikun qed jingħata għall - “ kura biex jiżdied id- demm li jagħmel il- pazjent innifsu ”: infart mijokardjali jew puplesija fix- xahar ta ’ qabel it- trattament, angina pectoris mhux stabbli, riskju akbar ta ’ deep venous thrombosis bħal storja ta ’ mard tromboemboliku fil- vini.
If there is an increase in platelets of more than 150 x 109/ l or if platelets rise above the normal range, treatment with NeoRecormon should be discontinued.
4. 4 Avviżi speċjali u prekawzjonijiet għall- użu
In chronic renal failure patients an increase in heparin dose during haemodialysis is frequently required during the course of therapy with NeoRecormon as a result of the increased packed cell volume.
NeoRecormon għandu jintuża b’ kawtela meta jkun hemm anemija refrattorja b’ eċċess ta ’ blasts li jkunu għadhom qed jiffurmaw, epilessija, tromboċitosi u insuffiċjenza kronika tal- fwied.
Occlusion of the dialysis system is possible if heparinisation is not optimum.
Wieħed għandu jiżgura li m’ hemmx defiċjenza ta ’ folic acid u vitamina B12 għax dawn inaqqsu l- effikaċja ta ’ NeoRecormon.
Early shunt revision and thrombosis prophylaxis by administration of acetylsalicylic acid, for example, should be considered in chronic renal failure patients at risk of shunt thrombosis.
Biex tkun żgurata l- formazzjoni effettiva taċ- ċelluli tad- demm ħomor, għandu jkun evalwat l- istat tal - ħadid għal kull pazjent qabel u waqt il- kura, u jista ’ jkun hemm bżonn ta ’ terapija supplimentari bil - ħadid li għandha tingħata skond il- linji gwida tat- terapija.
Serum potassium and phosphate levels should be monitored regularly during therapy with NeoRecormon.
Togħbija severa ta ’ aluminju minħabba kura ta ’ insuffiċjenza tal- kliewi tista ’ tnaqqas l- effikaċja ta ’ NeoRecormon.
If an elevated or rising potassium level is observed then consideration should be given to ceasing administration of NeoRecormon until the level has been corrected.
L- indikazzjoni għall- kura b’ NeoRecormon ta ’ pazjenti nefrosklerotiċi li għadhom ma bdewx id- dijalisi, għandha tiġi ddefinita ndividwalment, għax l- possibiltà ta ’ aċċelerazzjoni ta ’ progressjoni ta ’ insuffiċjenza renali ma tistax titwarrab b’ ċertezza.
For use of NeoRecormon in an autologous predonation programme, the official guidelines on principles of blood donation must be considered, in particular:
Aplasja pura taċ- ċelluli ħomor ikkawżata minn antikorpi newtralizzanti kontra l- eritropoetin, kienet irrappurtata f’ assoċjazzjoni ma ’ terapija b’ eritropoetin, inkluż NeoRecormon.
- only patients with a PCV ≥ 33% (haemoglobin ≥ 11 g/ dl [6.83 mmol/ l]) should donate;
Dawn iż- żidiet fil- pressjoni tad- demm jistgħu jiġu kkurati b’ prodotti mediċinali.
- special care should be taken with patients below 50 kg weight;
Jekk iż- żjieda fil - pressjoni tad- demm ma tistax tiġi kkontrollata minn terapija b’ mediċini, interuzzjoni għal ftit taż - żmien tat- terapija b’ NeoRecorman hija rakkomandata.
12% of the patient's estimated blood
Speċjalment fil- bidu tat- terapija, hija rakkomandata sorveljanza regolari tal- pressjoni tad- demm, inkluż bejn dijalisi u ieħor.
Treatment should be reserved for patients in whom it is considered of particular importance to avoid homologous blood transfusion taking into consideration the risk/ benefit assessment for homologous transfusions.
F’ pazjenti b’ insuffiċjenza kronika tal- kliewi jista ’ jkun hemm żjieda fl- għadd ta ’ plejtlits, li tibqa ’ fil - limiti normali, li tkun tiddependi mid- doża ta ’ NeoRecormon, speċjalment wara li jingħata ġol- vini.
Misuse by healthy persons may lead to an excessive increase in packed cell volume.
Din tonqos tul il- kors tat- terapija.
This may be associated with life-threatening complications of the cardiovascular system.
Huwa rakkomandat li l- għadd ta ’ plejtlits ikun issorveljat regolarment matul l- ewwel 8 ġimgħat ta ’ terapija.
NeoRecormon in pre-filled syringe contains up to 0.3 mg phenylalanine/ syringe as an excipient.
F’ pazjenti b’ insuffiċjenza kronika tal- kliewi, l- konċentrazzjoni ta ’ l- emoglobina miżmuma m’ għandhiex taqbeż il- limitu ta ’ fuq tal- konċentrazzjoni mmirata ta ’ l- emoglobina rakkomandata f’ sezzjoni 4. 2.
Therefore this should be taken into consideration in patients affected with severe forms of phenylketonuria.
Fi provi kliniċi, kienet osservata żjieda fir- riskju ta ’ mewt u ta ’ episodji kardjovaskulari serji meta sustanzi li jistimolaw l- eritropoesi (ESAs) ingħataw biex tintlaħaq emoglobina ta ’ aktar minn 12 g/ dl (7. 5 mmol/ l).
160 This medicinal product contains less than 1 mmol sodium (23 mg) per syringe, i. e. essentially “ sodium-free”.
164 Provi kliniċi kkontrollati ma wrewx benefiċċji sinifikanti attribwiti lill- għoti ta ’ epoetins meta l - konċentrazzjoni ta ’ l- emoglobina tiżdied ’ il fuq mil- livell neċessarju għall- kontroll ta ’ sintomi ta ’ l - anemija u biex tiġi evitata trasfużjoni tad- demm.
4.5 Interaction with other medicinal products and other forms of interaction
Fi trabi prematuri, jista ’ jkun hemm żjieda żgħira fl- għadd ta ’ plejtlits, partikolarment sa 12- 14- il ġurnata ta ’ ħajja, għalhekk il- plejtlits għandhom jiġu sorveljati regolarment.
The clinical results obtained so far do not indicate any interaction of NeoRecormon with other medicinal products.
Effett fuq it- tkabbir tat- tumur Epoetins huma fatturi tat- tkabbir li primarjament jistimolaw il- produzzjoni ta ’ ċelluli ħomor tad- demm.
Animal experiments revealed that epoetin beta does not increase the myelotoxicity of cytostatic medicinal products like etoposide, cisplatin, cyclophosphamide, and fluorouracil.
Riċetturi għall- eritropoetin jistgħu jinstabu fuq il- wiċċ ta ’ diversi ċelluli tat- tumur.
For epoetin beta no clinical data on exposed pregnancies are available.
Bħal bil- fatturi tat - tkabbir kollha, hemm il- biża li epoetins jistgħu jistimolaw it- tkabbir ta ’ tumuri.
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/ foetal development, parturition or postnatal development (see 5.3).
F’ bosta studji kkontrollati, epoetins ma ntwerewx li jtejbu s- sopravivenza globali jew inaqqsu r- riskju tal - progressjoni tat- tumur f’ pazjenti b’ anemija assoċjata ma ’ kanċer.
Caution should be exercised when prescribing to pregnant women.
Fi studji kliniċi kkontrollati, l- użu ta ’ NeoRecormon u sustanzi oħra li jistimolaw l- eritropoesi wrew:
4.7 Effects on ability to drive and use machines
- ħin imqassar sal- progressjoni tat- tumur f’ pazjenti b’ kanċer avvanzat fir- ras u fl- għonq li qed
NeoRecormon has no influence on the ability to drive and use machines.
jirċievu terapija ta ’ radjazzjoni meta mogħti biex tintlaħaq emoglobina ta ’ aktar minn 14 g/ dl (8. 7 mmol/ l),
4.8 Undesirable effects
- sopravivenza globali mqassra u żjieda fl- imwiet attribwiti lill- progressjoni tal- marda wara 4
Based on results from clinical trials including 1725 patients approximately 8% of patients treated with NeoRecormon are expected to experience adverse reactions.
xhur f’ pazjenti b’ kanċer metastatiku tas- sider li qed jirċievu kimoterapija meta mogħti biex tintlaħaq emoglobina ta ’ 12- 14 g/ dl (7. 5- 8. 7 mmol/ l),
- Anaemic patients with chronic renal failure
- żjieda fir- riskju ta ’ mewt meta mogħti biex tintlaħaq emoglobina ta ’ 12 g/ dl (7. 5 mmol/ l)
The most frequent adverse reaction during treatment with NeoRecormon is an increase in blood pressure or aggravation of existing hypertension, especially in cases of rapid PCV increase (see section 4.4).
Minħabba l- punti msemmijin fuq, f’ xi sitwazzjonijiet kliniċi trasfużjonijiet tad- demm għandhom ikunu l- kura ppreferita għall- immanniġġjar ta ’ anemija f’ pazjenti bil- kanċer.
Hypertensive crisis with encephalopathy-like symptoms (e. g. headaches and confused state, sensorimotor disorders - such as speech disturbance or impaired gait - up to tonoclonic seizures) may also occur in individual patients with otherwise normal or low blood pressure (see section 4.4).
Id- deċiżjoni li jingħataw eritropoetins rikombinanti għandha tkun ibbażata fuq valutazzjoni tar- riskji/ benefiċċji bil - parteċipazzjoni tal- pazjent individwali, li għandha tikkunsidra l- kuntest kliniku speċifiku.
Shunt thromboses may occur, especially in patients who have a tendency to hypotension or whose arteriovenous fistulae exhibit complications (e. g. stenoses, aneurisms), see section 4.4.
Jista ’ jkun hemm żjieda fil- pressjoni tad- demm li tista ’ tiġi kkurata b’ mediċini.
In most cases, a fall in serum ferritin values simultaneous with a rise in packed cell volume is observed (see section 4.4).
Għalhekk huwa rakkomandat li tiġi sorveljata l- pressjoni tad- demm, speċjalment fil- fażi tal- bidu tal- kura f’ pazjenti bil - kanċer.
In addition, transient increases in serum potassium and phosphate levels have been observed in isolated cases (see section 4.4).
L- għadd ta ’ plejtlits u l- livell ta ’ emoglobina ukoll għandhom jiġu sorveljati f’ intervalli regolari f’ pazjenti bil- kanċer.
In isolated cases, neutralising anti erythropoietin antibody-mediated pure red cell aplasia (PRCA) associated with NeoRecormon therapy has been reported.
Jista ’ jkun hemm żjieda fl- għadd ta ’ plejtlits li fil- biċċa l- kbira tibqa ’ f’ limiti normali, f’ pazjenti li jkunu qegħdin fi programm fejn jingħatalhom id- demm tagħhom stess.
In case anti-erythropoietin antibody- mediated PRCA is diagnosed, therapy with NeoRecormon must be discontinued and patients should not be switched to another erythropoietic protein (see section 4.4).
Jekk ikun hemm żjieda ikbar minn 150 x 109/ l jew jekk il- plejtlits jiżdiedu iktar mill- limitu normali, il- kura b’ NeoRecormon għandha titwaqqaf.
The incidences of undesirable effects in clinical trials, considered related to treatment with NeoRecoromon are shown in the table below.
F’ pazjenti b’ insuffiċjenza kronika tal- kliewi żjieda fid- doża tal- heparin waqt id- dijalisi tad- demm spiss tkun bżonnjuża tul il- kors ta ’ terapija b’ NeoRecormon minħabba li dan iżid il- volum ta ’ ċelluli ppakjati.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Jekk il- heparinisation ma tkunx l- aħjar, jista ’ jkun hemm okklużjoni tal- magna tad- dijalisi.
System Organ Class
F’ pazjenti b’ insuffiċjenza kronika tal- kliewi li għandhom riskju ta ’ shunt thrombosis, għandu jiġi ikkunsidrat li ssir reviżjoni ta ’ shunts u lqugħ għat- trombożi billi jingħata acetylsalicylic acid, per eżempju.
Adverse Drug Reaction
Jekk ikun osservat livell ogħli ta ’ potassju
Incidence
165 jew li l- livell ikun qed jiżdied għandu jkun ikkunsidrat li jitwaqqaf NeoRecormon sakemm il- livell ikun irranġat.
Vascular disorders
Biex NeoRecormon jintuża fuq pazjenti li jkunu fi programm fejn jingħataw id- demm tagħhom stess, għandhom jiġu kkunsidrati l- linji gwida uffiċjali dwar il- prinċipji tad- donazzjoni tad- demm, partikolarment: jistgħu jagħtu d- demm biss pazjenti b’ PCV ≥ 33% (emoglobina ≥ 11 g/ dl [6. 83 mmol/ l];
Hypertensive crisis Hypertension
-
Uncommon (> 0.1% ,< 1%) Common (> 1% ,< 10%)
- kura speċjali trid tingħata lil pazjenti li jiżnu inqas minn 50 kg;
Nervous system disorders Blood and the lymphatic system disorders
- il- volum meħud f’ darba m’ għandux jaqbeż bejn wieħed u ieħor it- 12% ta ’ dak li hu stmat li hu
Headache Shunt thrombosis Thrombocytosis
il- volum tad- demm tal- pazjent.
Common (> 1% ,< 10%) Rare (> 0.01% ,< 0.1%) Very rare (< 0.01%)
Dan jista ’ jkun assoċjat ma ’ kumplikazzjonijiet fis- sistema kardjovaskulari li joħolqu periklu ta ’ mewt.
161
NeoRecormon jista ’ jkun fih sa 0. 3 mg ta ’ phenylalanine/ kunjett bħala sustanza mhux attiva.
Epoetin beta treatment-related headache and hypertension which can be treated with drugs are common (> 1%, < 10%) (see section 4.4).
Għalhekk, dan għandu jkun ikkunsidrat f’ każ ta ’ pazjenti li jbatu minn forom severi ta ’ phenylketonuria.
In some patients, a fall in serum iron parameters is observed (see section 4.4).
Dan il- prodott mediċinali fih inqas minn 1 mmol ta ’ sodju (23 mg) kull siringa, i. e. essenzjalment “ bla sodju ”.
Clinical studies have shown a higher frequency of thromboembolic events in cancer patients treated with NeoRecormon compared to untreated controls or placebo.
4. 5 Prodotti mediċinali oħra li ma jaqblux ma ’ dan il- prodott u affarijiet oħra li jistgħu jibdlu l- effett farmaċewtiku tal- prodott
The incidences of undesirable effects in clinical trials, considered related to treatment with NeoRecoromon are shown in the table below.
Ir- riżultati kliniċi miksubin s’ issa ma jurux li hemm interazzjoni ta ’ NeoRecormon ma ’ prodotti mediċinali oħra.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Esperimenti fuq l- annimali wrew li epoetin beta ma jżidx il- mijelotossiċità ta ’ prodotti mediċinali ċitostatiċi bħal etoposide, cisplatin, cyclophosphamide, u fluorouracil.
System Organ Class
4. 6 Tqala u treddigħ
Adverse Drug Reaction
Għall- epoetin beta m’ hemmx tagħrif kliniku dwar l- użu waqt it- tqala.
Vascular disorders Blood and the lymphatic system disorders
Wieħed għandu joqgħod attent meta jikteb riċetta għal din il- mediċina għal nisa tqal.
Hypertension Thromboembolic event
4. 7 Effetti fuq il- ħila biex issuq u tħaddem magni
Common (> 1% ,< 10%) Common (> 1% ,< 10%)
NeoRecormon m’ għandu l- ebda effett fuq il- ħila biex issuq u tħaddem magni.
Nervous system disorders
4. 8 Effetti mhux mixtieqa
Headache
Skond ir- riżultati miksubin minn provi kliniċi li nkludew 1725 pazjent, madwar 8% tal- pazjenti kkurati b’ NeoRecormon huma mistennija li jkollhom esperjenza ta ’ reazzjonijiet avversi.
Common (> 1%, < 10%)
- Pazjenti anemiċi b’ insuffiċjenza kronika tal- kliewi
- Patients in an autologous blood predonation programme
Ir- reazzjoni avversa li tinħass l- iktar spiss waqt il- kura b’ NeoRecormon hija żjieda fil- pressjoni tad - demm jew l- aggravazzjoni ta ’ pressjoni għolja eżistenti, speċjalment f’ każijiet fejn hemm żjieda f’ daqqa tal- PCV (ara sezzjoni 4. 4).
Patients in an autologous blood predonation programme have been reported to show a slightly higher frequency of thromboembolic events.
Fil- maġġoranza tal- każijiet, ikun osservat tnaqqis fil- valuri ta ’ ferritin fis- serum flimkien ma ’ żjieda fil- volum ta ’ ċelluli ppakkjati (ara sezzjoni 4. 4).
However, a causal relationship with treatment with NeoRecormon could not be established.
Barra minn hekk, f’ każijiet iżolati, kienu osservati żjiediet temporanji fil- livelli ta ’ potassju u fosfat fis- serum (ara sezzjoni 4. 4).
In placebo controlled trials temporary iron deficiency was more pronounced in patients treated with NeoRecormon than in controls (see section 4.4).
F’ każijiet iżolati kienet irrappurata aplasja pura taċ- ċelluli ħomor (PRCA) ikkawżata minn antikorpi newtralizzanti kontra l- eritropoetin, f’ assoċjazzjoni ma ’ terapija b’ NeoRecormon.
System Organ Class
Inċidenża
Adverse Drug Reaction
Disturbi vaskulari
Incidence
Kriżi ipertensiva
Nervous system disorders
Mhux komuni (> 0. 1%, < 1%)
Headache
Pressjoni għolja
- Premature infants
Disturbi fis- sistema nervuża
A fall in serum ferritin values
Uġigħ ta ’ ras
is very common (> 10%) (see
Komuni (> 1%, < 10%)
section 4.4).
Rari (> 0. 01%, < 0. 1%) Rari ħafna (< 0. 01%)
- All indications
- Pazjenti bil- kanċer
Rarely (≥ 1/ 10.000 to ≤ 1/ 1.000), epoetin beta treatment-related skin reactions such as rash, pruritus, urticaria or injection site reactions may occur.
Uġigħ ta ’ ras u pressjoni għolja li tista ’ tiġi kkontrollata b’ mediċini, relatati ma ’ kura b’ epoetin beta, huma komuni (> 1%, < 10%) (ara sezzjoni 4. 4).
In very rare cases (≤ 1/ 10.000), epoetin beta treatment- related anaphylactoid reactions have been reported.
F’ xi pazjenti, huwa osservat tnaqqis fil- parametri ta ’ ħadid fis- serum (ara sezzjoni 4. 4).
However, in controlled clinical studies no increased incidence of hypersensitivity reactions was found.
L- inċidenza ta ’ effetti mhux mixtieqa fi studji kliniċi, kkunsidrati relatati ma ’ kura b’ NeoRecoromon huma mniżżla fit- tabella taħt.
In very rare cases (≤ 1/ 10.000), particularly when starting treatment, epoetin beta treatment-related flu- like symptoms such as fever, chills, headaches, pain in the limbs, malaise and/ or bone pain have been reported.
F’ kull sezzjoni ta ’ frekwenza, l- effetti mhux mixtieqa għandhom jitniżżlu skond is- serjetà tagħhom.
These reactions were mild or moderate in nature and subsided after a couple of hours or days.
L- effetti li huma l- aktar serji għandhom jitniżżlu l- ewwel, segwiti minn dawk anqas serji.
4.9 Overdose
Inċidenża
The therapeutic margin of NeoRecormon is very wide.
Disturbi vaskulari Disturbi tad- demm u tas - sistema limfatika
Even at very high serum levels no symptoms of poisoning have been observed.
Pressjoni għolja Avveniment trombo - embolitiku
PHARMACOLOGICAL PROPERTIES
Komuni (> 1%, < 10%) Komuni (> 1%, < 10%)
5.1 Pharmacodynamic properties
Disturbi fis- sistema nervuża
B03XA
Komuni (> 1%, < 10%)
Epoetin beta is identical in its amino acid and carbohydrate composition to erythropoietin that has been isolated from the urine of anaemic patients.
- Pazjenti fi programm ta ’ donazzjoni minn qabel ta ’ demm awtologu
Erythropoietin is a glycoprotein that stimulates the formation of erythrocytes from its committed progenitors.
Pazjenti fi programm ta ’ donazzjoni minn qabel ta ’ demm awtologu kienu rrappurtati li juru frekwenza ta ’ avvenimenti trombo- embolitiċi kemmxejn akbar.
It acts as a mitosis stimulating factor and differentiation hormone.
Madankollu, ma tistax tiġi stabbilita relazzjoni kawżali ma ’ kura b’ NeoRecormon.
The biological efficacy of epoetin beta has been demonstrated after intravenous and subcutaneous administration in various animal models in vivo (normal and uraemic rats, polycythaemic mice, dogs).
Fi provi kliniċi kontrollati bil- plaċebo, defiċjenza temporanja ta ’ ħadid deheret aktar f’ pazjenti kkurati b’ NeoRecormon meta mqabbla mal- gruppi ta ’ kontroll (ara sezzjoni 4. 4).
An increased 3H-thymidine incorporation in the erythroid nucleated spleen cells has been found in vitro (mouse spleen cell culture) after incubation with epoetin beta.
167 L- inċidenza ta ’ effetti mhux mixtieqa fi studji kliniċi, kkunsidrati relatati ma ’ kura b’ NeoRecoromon huma mniżżla fit- tabella taħt.
Investigations in cell cultures of human bone marrow cells showed that epoetin beta stimulates erythropoiesis specifically and does not affect leucopoiesis.
F’ kull sezzjoni ta ’ frekwenza, l- effetti mhux mixtieqa għandhom jitniżżlu skond is- serjetà tagħhom.
Cytotoxic actions of epoetin beta on bone marrow or on human skin cells were not detected.
L- effetti li huma l- aktar serji għandhom jitniżżlu l- ewwel, segwiti minn dawk anqas serji.
After single dose administration of epoetin beta no effects on behaviour or locomotor activity of mice and circulatory or respiratory function of dogs were observed.
Sistema tal- klassifika tal - organi
Erythropoietin is a growth factor that primarily stimulates red cell production.
Reazzjoni Avversa tal- Mediċina
Erythropoietin receptors may be expressed on the surface of a variety of tumour cells.
Disturbi fis- sistema nervuża
Two of the studies recruited patients who were being treated with chemotherapy.
Tnaqqis fil- valuri ta ’ ferritin fis- serum huwa komuni ħafna (> 10%) (ara sezzjoni 4. 4).
The target haemoglobin concentration in two studies was > 13 g/ dl; in the remaining three studies it was 12- 14 g/ dl.
Rarament (≥1/ 10. 000 to ≤1/ 1. 000), reazzjonijiet tal- ġilda relatati ma ’ kura b’ epoetin beta, bħal raxx, ħakk, urtikarja jew reazzjonijiet fis- sit ta ’ l- injezzjoni jistgħu jiġru.
In the open-label study there was no difference in overall survival between patients treated with recombinant human erythropoietin and controls.
F’ każijiet rari ħafna (≤1/ 10. 000), kienu rrappurtati reazzjonijiet anafilattiċi relatati ma ’ kura b’ epoetin beta.
In the four placebo-controlled studies the hazard ratios for overall survival ranged between 1.25 and 2.47 in favour of controls.
Madankollu, fi studji kliniċi ikkontrollati ma nstabet l- ebda żjieda fl- inċidenza ta ’ reazzjonijiet ta ’ sensittività eċċessiva.
These studies have shown a consistent unexplained statistically significant excess mortality in patients who have anaemia associated with various common cancers who received recombinant human erythropoietin compared to controls.
F’ każijiet rari ħafna (≤1/ 10. 000), partikolarment fil- bidu tal- kura, kienu rrappurtati sintomi jixbħu lill - influwenza, bħal deni, dehxiet, uġigħ ta ’ ras, uġigħ fid- dirgħajn u fir- riġlejn, telqa u/ jew uġigħ fl - għadam, relatati ma ’ kura b’ epoetin beta.
Overall survival outcome in the trials could 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.
Dawn ir- reazzjonijiet kienu ħfief għal- moderati fin- natura u għaddew wara ftit sigħat jew jiem.
In patients with baseline haemoglobin ≤ 10 g/ dl (n=899), the hazard ratio point estimate for survival was 0.98 (95% CI 0.68 to 1.40).
Il- marġni terapewtiku ta ’ NeoRecormon huwa wiesa ’ ħafna.
An increased relative risk for thromboembolic events was observed in the overall population (RR 1.62, 95% CI:
Lanqas f’ livelli għoljin ħafna fis- serum ma dehru sintomi ta ’ avvelenament.
1.13, 2.31).
TAGĦRIF FARMAKOLOĠIKU
0.99, 1.18; 42 trials and 8167 patients).
5. 1 Tagħrif farmakodinamiku
An increased relative risk of thromboembolic events (RR 1.67, 95% CI:
B03XA
1.35, 2.06, 35 trials and 6769 patients) was observed in patients treated with recombinant human erythropoietin.
Epoetin beta huwa identiku fl- amino acids u l- karboidrati tiegħu, għall- eritropoetin li kien iżolat mill - urina ta ’ pazjenti anemiċi.
There is therefore consistent evidence to suggest that there may be significant harm to patients with cancer who are treated with recombinant human erythropoietin.
Eritropoetin hu glikoproteina li tistimola l- formazzjoni ta ’ ċelluli ħomor tad- demm mill- proġenituri tagħhom.
The extent to which these outcomes might apply to the administration of recombinant human erythropoietin to patients with cancer, treated with chemotherapy to achieve
Jaħdem bħala fattur li jistimola l- mitożi u bħala ormon ta ’ divrenzjar.
163 haemoglobin concentrations less than 13 g/ dl, is unclear because few patients with these characteristics were included in the data reviewed.
L- effikaċja bijoloġika ta ’ epoetin beta kienet murija wara li ngħatat minn taħt il- ġilda u minn ġol- vini lil diversi annimali in vivo li ntużaw bħala mudell (firien normali u uremiċi, ġrieden poliċitemiċi, klieb).
In very rare cases, neutralising anti-erythropoietin antibodies with or without pure red cell aplasia (PRCA) occurred during rHuEPO therapy.
Instabet żjieda fl- inkorporazzjoni ta ’ 3H thymidine f’ ċelluli eritrojdi b’ nukleu tal- milsa in vitro (kultura ta ’ ċelluli tal- milsa tal- ġrieden) wara inkubazzjoni b’ epoetin beta.
5.2 Pharmacokinetic properties
Wara amministrazzjoni ta ’ doża waħda ta ’ epoetin beta ma kienux osservati effetti fuq l- imġieba jew fil- mod ta ’ ċaqliq ta ’ ġrieden u fil- funzjonijiet ċirkulatorji u respiratorji tal- klieb.
Pharmacokinetic investigations in healthy volunteers and uraemic patients show that the half-life of intravenously administered epoetin beta is between 4 and 12 hours and that the distribution volume corresponds to one to two times the plasma volume.
Eritropoetin huwa fattur tat- tkabbir li primarjament jistimola l- produzzjoni ta ’ ċelluli ħomor.
Analogous results have been found in animal experiments in uraemic and normal rats.
Riċetturi għall- eritropoetin jistgħu jinstabu fuq il- wiċċ ta ’ diversi ċelluli tat- tumur.