qanastek/EMEA-V3 huggingface dataset:
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.
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.
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.
68 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.
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.
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.
As with all growth factors, there is a concern that epoetins could stimulate the growth of tumours.
Bħal bil- fatturi tat - tkabbir kollha, hemm il- biża li epoetins jistgħu jistimolaw it- tkabbir tumuri.
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.
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.
Serum potassium and phosphate levels should be monitored regularly during therapy with NeoRecormon.
Livelli tal- potassju u l- fosfat fis- serum għandhom ikunu issorveljati regolarment waqt terapija b’ 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.
Jekk ikun osservat livell ogħli ta ’ potassju
For use of NeoRecormon in an autologous predonation programme, the official guidelines on principles of blood donation must be considered, in particular:
69 jew li l- livell ikun qed jiżdied għandu jkun ikkunsidrat li jitwaqqaf NeoRecormon sakemm il- livell ikun irranġat.
- only patients with a PCV ≥ 33% (haemoglobin ≥ 11 g/ dl [6.83 mmol/ l]) should donate;
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];
NeoRecormon in pre-filled syringe contains up to 0.3 mg phenylalanine/ syringe as an excipient.
NeoRecormon jista ’ jkun fih sa 0. 3 mg ta ’ phenylalanine/ kunjett bħala sustanza mhux attiva.
64 This medicinal product contains less than 1 mmol sodium (23 mg) per syringe, i. e. essentially “ sodium-free”.
Dan il- prodott mediċinali fih inqas minn 1 mmol ta ’ sodju (23 mg) kull siringa, i. e. essenzjalment “ bla sodju ”.
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.
70 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.
The incidences of undesirable effects in clinical trials, considered related to treatment with NeoRecoromon are shown in the table below.
71 L- inċidenza ta ’ effetti mhux mixtieqa fi studji kliniċi, kkunsidrati relatati ma ’ kura b’ NeoRecoromon huma mniżżla fit- tabella taħt.
- Premature infants
- Trabi prematuri
is very common (> 10%) (see
Tnaqqis fil- valuri ta ’ ferritin fis- serum huwa komuni ħafna (> 10%) (ara sezzjoni 4. 4).
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.
72 Is- sopravivenza u l- progressjoni tat- tumur ġew eżaminati f’ ħames studji kbar ikkontrollati li kienu jinvolvu total ta ’ 2833 pazjent, li fosthom erbgħa kienu double- blind u kkontrollati bil- plaċebo u wieħed kien studju open- label.
67 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.
Urea, Sodium chloride, Polysorbate 20, Sodium dihydrogen phosphate dihydrate, Disodium phosphate dodecahyrate, Calcium chloride dihydrate, Glycine, L-Leucine, L-Isoleucine, L-Threonine, L-Glutamic acid, L-Phenylalanine, Water for injections.
Urea, Sodium chloride, Polysorbate 20, Sodium dihydrogen phosphate dihydrate Disodium phosphate dodecahyrate, Calcium chloride dihydrate, Glycine, L- Leucine, L- Isoleucine, L- Threonine, L- Glutamic acid, L- Phenylalanine, Ilma għall- injezzjonijiet.
68 6.4 Special precautions for storage
6. 4 Prekawzjonijiet speċjali għall- ħażna
Keep the pre-filled syringe in the outer carton, in order to protect from light.
Żomm is- siringa mimlija għal- lest fil- kartuna ta ’ barra, sabiex tilqa ’ mid- dawl.
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- perijodu wieħed ta ’ mhux aktar minn tlett ijiem.
0.3 ml of solution in pre-filled syringe (Type I glass) with a tip cap and a plunger stopper (teflonised rubber) with a needle 30G1/ 2.
0. 3 ml ta ’ soluzzjoni f’ siringa mimlija għal lest (ħġieġ Tip I), b’ għatu tat- tarf u tap tal- planġer (materjal tal- lasktuteflonizzata), b’ labra 30G1/ 2.
Pack sizes of 1 or 6 Not all pack sizes may be marketed.
Daqsijiet tal- pakkett ta ’ 1 jew 6.
First wash your hands!
L- ewwel aħsel idejk!
Remove one syringe from the pack and check that the solution is clear, colourless and practically free from visible particles.
Neħħi siringa waħda mill- pakkett u ara li s- soluzzjoni tkun ċara, bla kulur u prattikament mingħajr frak li jidhru.
Remove the cap from the syringe.
Neħħi l- għatu mis- siringa.
Remove one needle from the pack, fix it on the syringe and remove the protective cap from the needle.
Neħħi labra waħda mill- pakkett, waħħalha mas- siringa u neħħi l- għatu ta ’ protezzjoni minn mal- labra.
Expel air from the syringe and needle by holding the syringe vertically and gently pressing the plunger upwards.
Żomm is- siringa wieqfa u mbotta il- planġer ’ il fuq biex titneħħa l- arja mis- siringa u il- labra.
Keep pressing the plunger until the amount of NeoRecormon in the syringe is as prescribed.
Ibqa ’ mbotta il- planġer sakemm ikun hemm NeoRecormon fis- siringa daqs kemm għandu jingħata.
Clean the skin at the site of injection using an alcohol wipe.
Naddaf il- ġilda fejn se tkun se tingħata l- injezzjoni b’ inselħa ta ’ l- akoħol.
Form a skin fold by pinching the skin between thumb and forefinger.
Ifforma tinjafil- ġilda billi toqros il- ġilda bejn is- saba ’ l- kbir u l- werrej.
Hold the syringe barrel near to the needle, and insert the needle into the skin fold with a quick, firm action.
Aqbad is- siringa minn post l- eqreb lejn il - labra u daħħalha fil- ġilda b’ moviment ħafif u sod.
Inject the NeoRecormon solution.
Injetta s- soluzzjoni ta ’ NeoRecormon.
This medicinal product is for single use only.
Dan il- prodott mediċinali huwa għall- użu ta ’ darba biss.
NeoRecormon 1000 IU solution for injection in pre-filled syringe
NeoRecormon 1000 IU soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest
One pre-filled syringe with 0.3 ml solution for injection contains 1000 international units (IU) corresponding to 8.3 micrograms epoetin beta* (recombinant human erythropoietin).
Siringa waħda mimlija għal- lest b’ 0. 3 ml soluzzjoni għall- injezzjoni li fiha 1000 unità internazzjonali (IU) li jikkorrespondu għal 8. 3 mikrogrammi epoetin beta * (eritropoetin rikombinanti uman).
One ml solution for injection contains 3333 IU epoetin beta.
Kull ml ta ’ soluzzjoni għall- injezzjoni fiha 3333 IU epoetin beta.
- Treatment of symptomatic anaemia associated with chronic renal failure (CRF) inadult and
- Kura ta ’ anemija sintomatika assoċjata ma ’ insuffiċjenza kronika tal- kliewi (CRF) f’ pazjenti
Treatment of symptomatic anaemia in adult and paediatric chronic renal failure patients:
76 Kura ta ’ anemija sintomatika f’ pazjenti adulti u pedjatriċi b’ insuffiċjenza kronika tal- kliewi:
NeoRecormon should be administered either subcutaneously or intravenously in order to increase
Is- sintomi u r- riżultat ta ’ l- anemija jistgħu jvarjaw bl- età, sess u effett globali tal- marda; valutazzjoni ta ’ tabib tal- progressjoni u l- kundizzjoni klinika tal- pazjent individwali hija neċessarja.
71 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.
77 Riżultati kliniċi fit- tfal urew li, ġeneralment iktar ma jkunu żgħar il- pazjenti iktar ikun hemm bżonn ta ’ dożi ta ’ NeoRecormon għoljin.
72 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.
78 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.
73 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:
4.3 Contraindications
79 4. 3 Kontra- indikazzjonijiet
74 4.4 Special warnings and precautions for use
4. 4 Avviżi speċjali u prekawzjonijiet għall- użu
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.
80 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.
For use of NeoRecormon in an autologous predonation programme, the official guidelines on principles of blood donation must be considered, in particular:
81 jew li l- livell ikun qed jiżdied għandu jkun ikkunsidrat li jitwaqqaf NeoRecormon sakemm il- livell ikun irranġat.
76 This medicinal product contains less than 1 mmol sodium (23 mg) per syringe, i. e. essentially “ sodium-free”.
Dan il- prodott mediċinali fih inqas minn 1 mmol ta ’ sodju (23 mg) kull siringa, i. e. essenzjalment “ bla sodju ”.
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.
82 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.
The incidences of undesirable effects in clinical trials, considered related to treatment with NeoRecoromon are shown in the table below.
83 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.
84 Is- sopravivenza u l- progressjoni tat- tumur ġew eżaminati f’ ħames studji kbar ikkontrollati li kienu jinvolvu total ta ’ 2833 pazjent, li fosthom erbgħa kienu double- blind u kkontrollati bil- plaċebo u wieħed kien studju open- label.
79 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.
Urea, Sodium chloride, Polysorbate 20, Sodium dihydrogen phosphate dihydrate, Disodium phosphate dodecahyrate, Calcium chloride dihydrate, Glycine, L-Leucine, L-Isoleucine, L-Threonine, L-Glutamic acid, L-Phenylalanine, Water for injections.
Urea, Sodium chloride, Polysorbate 20, Sodium dihydrogen phosphate dihydrate, Disodium phosphate dodecahydrate, Calcium chloride dihydrate, Glycine, L- Leucine, L- Isoleucine, L- Threonine, L- Glutamic acid, L- Phenylalanine, Ilma għall- injezzjonijiet.
80 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- perijodu wieħed ta ’ mhux aktar minn tlett ijiem
0.3 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. 3 ml ta ’ soluzzjoni f’ siringa mimlija għal lest (ħġieġ Tip I), b’ għatu tat- tarf u tap tal- planġer (materjal tal- lasktuteflonizzata), b’ labra 27G1/ 2.
NeoRecormon 2000 IU solution for injection in pre-filled syringe
NeoRecormon 2000 IU soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest
One pre-filled syringe with 0.3 ml solution for injection contains 2000 international units (IU) corresponding to 16.6 micrograms epoetin beta* (recombinant human erythropoietin).
Siringa waħda mimlija għal- lest b’ 0. 3 ml soluzzjoni għall- injezzjoni li fiha 2000 unità internazzjonali 0( IU) li jikkorrespondu għal 16. 6 mikrogrammi epoetin beta * (eritropoetin rikombinanti uman).
One ml solution for injection contains 6667 IU epoetin beta.
Kull ml ta ’ soluzzjoni għall- injezzjoni fiha 6667 IU epoetin beta.
Treatment of symptomatic anaemia in adult and paediatric chronic renal failure patients:
88 Kura ta ’ anemija sintomatika f’ pazjenti adulti u pedjatriċi b’ insuffiċjenza kronika tal- kliewi:
83 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).
The initial dosage is 3 x 20 IU/ kg body weight per week.
- Id- doża tal- bidu hi 3 × 20 IU/ kg piż tal- ġisem fil- ġimgħa.
The weekly dose can also be divided into daily doses.
ġimgħat b’ 3 × 20 IU/ kg u ġimgħa jekk iż- żjieda fl- Hb ma tkunx biżżejjed (< 0. 25 g/ dl kull ġimgħa) Id- doża ta ’ kull ġimgħa tista ’ wkoll tinqasam f’ dożi ta ’ kuljum.
Results of clinical studies in children have shown that, on average, the younger the patients, the higher the NeoRecormon doses required.
89 Riżultati kliniċi fit- tfal urew li, ġeneralment iktar ma jkunu żgħar il- pazjenti iktar ikun hemm bżonn ta ’ dożi ta ’ NeoRecormon għoljin.
84 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.
90 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.
85 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:
4.3 Contraindications
91 4. 3 Kontra- indikazzjonijiet
86 4.4 Special warnings and precautions for use
4. 4 Avviżi speċjali u prekawzjonijiet għall- użu
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.
92 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.
For use of NeoRecormon in an autologous predonation programme, the official guidelines on principles of blood donation must be considered, in particular:
93 jew li l- livell ikun qed jiżdied għandu jkun ikkunsidrat li jitwaqqaf NeoRecormon sakemm il- livell ikun irranġat.
88 This medicinal product contains less than 1 mmol sodium (23 mg) per syringe, i. e. essentially “ sodium-free”.
Dan il- prodott mediċinali fih inqas minn 1 mmol ta ’ sodju (23 mg) kull siringa, i. e. essenzjalment “ bla sodju ”.
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.
94 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.
The incidences of undesirable effects in clinical trials, considered related to treatment with NeoRecoromon are shown in the table below.
95 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.
96 Is- sopravivenza u l- progressjoni tat- tumur ġew eżaminati f’ ħames studji kbar ikkontrollati li kienu jinvolvu total ta ’ 2833 pazjent, li fosthom erbgħa kienu double- blind u kkontrollati bil- plaċebo u wieħed kien studju open- label.
91 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.
Urea, Sodium chloride, Polysorbate 20, Sodium dihydrogen phosphate dihydrate, Disodium phosphate dodecahyrate, Calcium chloride dihydrate, Glycine, L-Leucine, L-Isoleucine, L-Threonine, L-Glutamic acid, L-Phenylalanine, Water for injections.
Urea, Sodium chloride, Polysorbate 20, Sodium dihydrogen phosphate dihydrate Disodium phosphate dodecahydrate, Calcium chloride dihydrate, Glycine, L- Leucine, L- Isoleucine, L- Threonine, L- Glutamic acid, L- Phenylalanine, Ilma għall- injezzjonijiet.
92 6.4 Special precautions for storage
6. 4 Prekawzjonijiet speċjali għall- ħażna
0.3 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. 3 ml ta ’ soluzzjoni f’ siringa mimlija għal lest (ħġieġ Tip I), b’ għatu tat- tarf u tap tal- planġer (materjal tal- lasktu teflonizzata), b’ labra 27G1/ 2.
DATE OF REVISION OF THE TEXT
DATA TA ’ META ĠIETT RIVEDUTA L- KITBA
NeoRecormon 3000 IU solution for injection in pre-filled syringe
NeoRecormon 3000 IU soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest
One pre-filled syringe with 0.3 ml solution for injection contains 3000 international units (IU) corresponding to 24.9 micrograms epoetin beta* (recombinant human erythropoietin).
Siringa waħda mimlija għal- lest b’ 0. 3 ml soluzzjoni għall- injezzjoni li fiha 3000 unità internazzjonali (IU) li jikkorrespondu għal 24. 9 mikrogrammi epoetin beta * (eritropoetin rikombinanti uman).
Treatment of symptomatic anaemia in adult and paediatric chronic renal failure patients:
100 Kura ta ’ anemija sintomatika f’ pazjenti adulti u pedjatriċi b’ insuffiċjenza kronika tal- kliewi:
95 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.
101 Riżultati kliniċi fit- tfal urew li, ġeneralment iktar ma jkunu żgħar il- pazjenti iktar ikun hemm bżonn ta ’ dożi ta ’ NeoRecormon għoljin.
96 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.
102 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.
97 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:
4.3 Contraindications
103 4. 3 Kontra- indikazzjonijiet
98 4.4 Special warnings and precautions for use
4. 4 Avviżi speċjali u prekawzjonijiet għall- użu
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.
104 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.
For use of NeoRecormon in an autologous predonation programme, the official guidelines on principles of blood donation must be considered, in particular:
105 jew li l- livell ikun qed jiżdied għandu jkun ikkunsidrat li jitwaqqaf NeoRecormon sakemm il- livell ikun irranġat.
100 This medicinal product contains less than 1 mmol sodium (23 mg) per syringe, i. e. essentially “ sodium-free”.
Dan il- prodott mediċinali fih inqas minn 1 mmol ta ’ sodju (23 mg) kull siringa, i. e. essenzjalment “ bla sodju ”.
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.
106 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.
The incidences of undesirable effects in clinical trials, considered related to treatment with NeoRecoromon are shown in the table below.
107 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.
108 Is- sopravivenza u l- progressjoni tat- tumur ġew eżaminati f’ ħames studji kbar ikkontrollati li kienu jinvolvu total ta ’ 2833 pazjent, li fosthom erbgħa kienu double- blind u kkontrollati bil- plaċebo u wieħed kien studju open- label.
103 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.
104 6.4 Special precautions for storage
6. 4 Prekawzjonijiet speċjali għall- ħażna
NeoRecormon 4000 IU solution for injection in pre-filled syringe
NeoRecormon 4000 IU soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest
One pre-filled syringe with 0.3 ml solution for injection contains 4000 international units (IU) corresponding to 33.2 micrograms epoetin beta* (recombinant human erythropoietin).
Siringa waħda mimlija għal- lest b’ 0. 3 ml soluzzjoni għall- injezzjoni li fiha 4000 unità internazzjonali (IU) li jikkorrespondu għal 33. 2 mikrogrammi epoetin beta * (eritropoetin rikombinanti uman).
One ml solution for injection contains 13,333 IU epoetin beta.
Kull ml ta ’ soluzzjoni għall- injezzjoni fiha 13, 333 IU epoetin beta.
Treatment of symptomatic anaemia in adult and paediatric chronic renal failure patients:
112 Kura ta ’ anemija sintomatika f’ pazjenti adulti u pedjatriċi b’ insuffiċjenza kronika tal- kliewi:
107 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).
Subcutaneous use is preferable in patients who are not receiving haemodialysis to avoid puncture of peripheral veins. In case of intravenous administration, the solution should be injected over approx.
Użu minn taħt il- ġilda huwa preferibbli f’ pazjenti li mhux qed jirċievu emodijalisi biex jiġi evitat it- titqib ta ’ vini periferali.
Results of clinical studies in children have shown that, on average, the younger the patients, the higher the NeoRecormon doses required.
113 Riżultati kliniċi fit- tfal urew li, ġeneralment iktar ma jkunu żgħar il- pazjenti iktar ikun hemm bżonn ta ’ dożi ta ’ NeoRecormon għoljin.
108 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.
114 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.
109 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:
4.3 Contraindications
115 4. 3 Kontra- indikazzjonijiet
110 4.4 Special warnings and precautions for use
4. 4 Avviżi speċjali u prekawzjonijiet għall- użu
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.
116 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.
For use of NeoRecormon in an autologous predonation programme, the official guidelines on principles of blood donation must be considered, in particular:
117 jew li l- livell ikun qed jiżdied għandu jkun ikkunsidrat li jitwaqqaf NeoRecormon sakemm il- livell ikun irranġat.
112 This medicinal product contains less than 1 mmol sodium (23 mg) per syringe, i. e. essentially “ sodium-free”.
Dan il- prodott mediċinali fih inqas minn 1 mmol ta ’ sodju (23 mg) kull siringa, i. e. essenzjalment “ bla sodju ”.
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.
118 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.
The incidences of undesirable effects in clinical trials, considered related to treatment with NeoRecoromon are shown in the table below.
119 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.
120 Is- sopravivenza u l- progressjoni tat- tumur ġew eżaminati f’ ħames studji kbar ikkontrollati li kienu jinvolvu total ta ’ 2833 pazjent, li fosthom erbgħa kienu double- blind u kkontrollati bil- plaċebo u wieħed kien studju open- label.
115 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.
116 6.4 Special precautions for storage
6. 4 Prekawzjonijiet speċjali għall- ħażna
Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom
Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 ITW Ir- Renju Unit
NeoRecormon 5000 IU solution for injection in pre-filled syringe
NeoRecormon 5000 IU soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest
One pre-filled syringe with 0.3 ml solution for injection contains 5000 international units (IU) corresponding to 41.5 micrograms epoetin beta* (recombinant human erythropoietin).
Siringa waħda mimlija għal- lest b’ 0. 3 ml soluzzjoni għall- injezzjoni li fiha 5000 unità internazzjonali (IU) li jikkorrespondu għal 41. 5 mikrogrammi epoetin beta * (eritropoetin rikombinanti uman).
One ml solution for injection contains 16,667 IU epoetin beta.
Kull ml ta ’ soluzzjoni għall- injezzjoni fiha 16, 667 IU epoetin beta.
Treatment of symptomatic anaemia in adult and paediatric chronic renal failure patients:
124 Kura ta ’ anemija sintomatika f’ pazjenti adulti u pedjatriċi b’ insuffiċjenza kronika tal- kliewi:
119 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.
125 Riżultati kliniċi fit- tfal urew li, ġeneralment iktar ma jkunu żgħar il- pazjenti iktar ikun hemm bżonn ta ’ dożi ta ’ NeoRecormon għoljin.
120 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.
126 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.
121 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:
4.3 Contraindications
127 4. 3 Kontra- indikazzjonijiet
122 4.4 Special warnings and precautions for use
4. 4 Avviżi speċjali u prekawzjonijiet għall- użu
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.
128 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.
For use of NeoRecormon in an autologous predonation programme, the official guidelines on principles of blood donation must be considered, in particular:
129 jew li l- livell ikun qed jiżdied għandu jkun ikkunsidrat li jitwaqqaf NeoRecormon sakemm il- livell ikun irranġat.
124 This medicinal product contains less than 1 mmol sodium (23 mg) per syringe, i. e. essentially “ sodium-free”.
Dan il- prodott mediċinali fih inqas minn 1 mmol ta ’ sodju (23 mg) kull siringa, i. e. essenzjalment “ bla sodju ”.
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.
130 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.
The incidences of undesirable effects in clinical trials, considered related to treatment with NeoRecoromon are shown in the table below.
131 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.
132 Is- sopravivenza u l- progressjoni tat- tumur ġew eżaminati f’ ħames studji kbar ikkontrollati li kienu jinvolvu total ta ’ 2833 pazjent, li fosthom erbgħa kienu double- blind u kkontrollati bil- plaċebo u wieħed kien studju open- label.
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.
127 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.
128 6.4 Special precautions for storage
6. 4 Prekawzjonijiet speċjali għall- ħażna
EU/ 1/ 97/ 031/ 033 - 034
NUMRU( I) TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ EU/ 1/ 97/ 031/ 033 - 034
NeoRecormon 6000 IU solution for injection in pre-filled syringe
NeoRecormon 6000 IU soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest
One pre-filled syringe with 0.3 ml solution for injection contains 6000 international units (IU) corresponding to 49.8 micrograms epoetin beta* (recombinant human erythropoietin).
Siringa waħda mimlija għal- lest b’ 0. 3 ml soluzzjoni għall- injezzjoni li fiha 6000 unità internazzjonali (IU) li jikkorrespondu għal 49. 8 mikrogrammi epoetin beta * (eritropoetin rikombinanti uman).
Treatment of symptomatic anaemia in adult and paediatric chronic renal failure patients:
136 Kura ta ’ anemija sintomatika f’ pazjenti adulti u pedjatriċi b’ insuffiċjenza kronika tal- kliewi:
131 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.
137 Riżultati kliniċi fit- tfal urew li, ġeneralment iktar ma jkunu żgħar il- pazjenti iktar ikun hemm bżonn ta ’ dożi ta ’ NeoRecormon għoljin.
132 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.
138 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.
133 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:
4.3 Contraindications
139 4. 3 Kontra- indikazzjonijiet
134 4.4 Special warnings and precautions for use
4. 4 Avviżi speċjali u prekawzjonijiet għall- użu
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.
140 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.
For use of NeoRecormon in an autologous predonation programme, the official guidelines on principles of blood donation must be considered, in particular:
141 jew li l- livell ikun qed jiżdied għandu jkun ikkunsidrat li jitwaqqaf NeoRecormon sakemm il- livell ikun irranġat.
136 This medicinal product contains less than 1 mmol sodium (23 mg) per syringe, i. e. essentially “ sodium-free”.
Dan il- prodott mediċinali fih inqas minn 1 mmol ta ’ sodju (23 mg) kull siringa, i. e. essenzjalment “ bla sodju ”.
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.
142 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.
In addition, transient increases in serum potassium and phosphate levels have been observed in isolated cases (see section 4.4).
Barra minn hekk, f’ każijiet iżolati, kienu osservati żiediet temporanji fil- livelli ta ’ potassju u fosfat 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.
143 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), epoetin beta treatment- related anaphylactoid reactions have been reported.
F’ każijiet rari ħafna (≤1/ 10. 000), kienu irrappurtati reazzjonijiet anafilattiċi relatati ma ’ kura b’ epoetin beta.
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.
144 Is- sopravivenza u l- progressjoni tat- tumur ġew eżaminati f’ ħames studji kbar ikkontrollati li kienu jinvolvu total ta ’ 2833 pazjent, li fosthom erbgħa kienu double- blind u kkontrollati bil- plaċebo u wieħed kien studju open- label.
139 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.
140 6.4 Special precautions for storage
6. 4 Prekawzjonijiet speċjali għall- ħażna
NeoRecormon 10,000 IU solution for injection in pre-filled syringe
NeoRecormon 10, 000 IU soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest
One pre-filled syringe with 0.6 ml solution for injection contains 10,000 international units (IU) corresponding to 83 micrograms epoetin beta* (recombinant human erythropoietin).
Siringa waħda mimlija għal- lest b’ 0. 6 ml soluzzjoni għall- injezzjoni li fiha 10, 000 unità internazzjonali (IU) li jikkorrespondu għal 83 mikrogrammi epoetin beta * (eritropoetin rikombinanti uman).
NeoRecormon in pre-filled syringe is a sterile but unpreserved product.
148 NeoRecormon ġo siringa mimlija għal- lest hu prodott sterili imma mhux ippreservat.
Treatment of symptomatic anaemia in adult and paediatric chronic renal failure patients:
Kura ta ’ anemija sintomatika f’ pazjenti adulti u pedjatriċi b’ insuffiċjenza kronika tal- kliewi:
143 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.
149 Riżultati kliniċi fit- tfal urew li, ġeneralment iktar ma jkunu żgħar il- pazjenti iktar ikun hemm bżonn ta ’ dożi ta ’ NeoRecormon għoljin.
144 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.
150 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.
145 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:
Men:
c:
(body weight ≥ 45 kg)
kg
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.
n
Male patients
30 Ü/ k rmo
Required amount of pre-donated blood [units]
TÜ
Endogenous red cell reserve [ml]
0 T co 5
The single dose thus determined is administered twice weekly over 4 weeks.
4 TÜ ie e
The maximum dose should not exceed 1600 IU/ kg body weight per week for intravenous or 1200 IU/ kg per week for subcutaneous administration.
2 ux j
4.3 Contraindications
i. v 00 jitt: 2
Hypersensitivity to the active substance or any of the excipients.
d
Poorly controlled hypertension.
i. v a
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.
ndu a g
146 4.4 Special warnings and precautions for use
a
NeoRecormon should be used with caution in the presence of refractory anaemia with excess blasts in transformation, epilepsy, thrombocytosis, and chronic liver failure.
g
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.
M
Severe aluminium overload due to treatment of renal failure may compromise the effectiveness of NeoRecormon.
Riserva ta ’ ċelluli ħomor endoġeni [ml]
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.
Riserva ta ’ ċelluli ħomor endoġeni [ml]
Pure red cell aplasia caused by neutralising anti-erythropoietin antibodies has been reported in association with erythropoietin therapy, including NeoRecormon.
Id- doża waħdanija ddeterminata b’ dan il- mod tingħata darbtejn fil- ġimgħa fuq medda ta ’ 4 ġimgħat.
These antibodies have been shown to cross-react with all erythropoietic proteins, and patients suspected or confirmed to have neutralising antibodies to erythropoietin should not be switched to NeoRecormon (see section 4.8).
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.
In chronic renal failure patients an increase in blood pressure or aggravation of existing hypertension, especially in cases of rapid PCV increase can occur.
Sensittività eċċessiva għas- sustanza attiva jew għal xi sustanzi mhux attivi.
These increases in blood pressure can be treated with medicinal products.
Pressjoni għolja mhux kontrollata tajjeb
Particularly at beginning of therapy, regular monitoring of the blood pressure is recommended, including between dialyses.
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.
Particular attention should be paid to sudden stabbing migraine like headaches as a possible warning sign.
4. 4 Avviżi speċjali u prekawzjonijiet għall- użu
In chronic renal failure patients there may be a moderate dose-dependent rise in the platelet count within the normal range during treatment with NeoRecormon, especially after intravenous administration.
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.
It is recommended that the platelet count be monitored regularly during the first 8 weeks of therapy.
Wieħed għandu jiżgura li m’ hemmx defiċjenza ta ’ folic acid u vitamina B12 għax dawn inaqqsu l- effikaċja ta ’ NeoRecormon.