qanastek/EMEA-V3 huggingface dataset:
14 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:
Anaemia symptoms and sequelae may vary with age, gender, and overall burden of disease; a physician’ s evaluation of the individual patient ’ s clinical course and condition is necessary.
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.
If it occurs, appropriate dose adjustment should be made as provided. If the rate of rise in haemoglobin is greater than 2 g/ dl (1.25 mmol/ l) in one month or if the haemoglobin level is increasing and approaching 12 g/ dl (7.45 mmol/ l), the dose is to be reduced by approximately 25%.
Jekk ir- rata ta ’ żjieda ta ’ emoglobina hija ikbar minn 2 g/ dl (1. 25 mmol/ l) f’ xahar wieħed, jew jekk il- livell ta ’ l- emoglobina qed jiżdied u jqarreb 12 g/ dl (7. 45 mmol/ l), id- doża għandha titnaqqas b’ madwar 25%.
The dosage may be increased every
Id- dożaġġ jista ’ jiġi miżjud kull 4
4 weeks by 3 x 20 IU/ kg and week if the increase of Hb is not adequate (< 0.25 g/ dl per week).
ġimgħat b’ 3 × 20 IU/ kg u ġimgħa jekk iż- żjieda fl- Hb ma tkunx biżżejjed (< 0. 25 g/ dl kull ġimgħa)
In the case of subcutaneous administration, the weekly dose can be given as one injection per week or in divided doses three or seven times per week.
Pazjenti li huma stabbli fuq dożaġġ
Patients who are stable on a once weekly dosing regimen may be switched to once every two weeks administration.
16 ta ’ darba fil- ġimgħa jistgħu jinqalbu għall- amministrazzjoni ta ’ darba kull ġimgħatejn.
Results of clinical studies in children have shown that, on average, the younger the patients, the higher the NeoRecormon doses required.
Riżultati kliniċi fit- tfal urew li, ġeneralment iktar ma jkunu żgħar il- pazjenti iktar ikun hemm bżonn ta ’ dożi ta ’ NeoRecormon għoljin.
15 Treatment with NeoRecormon is normally a long-term therapy.
Kura b’ NeoRecormon normalment hija terapija fit- tul.
Treatment of symptomatic chemotherapy-induced anaemia in cancer patients:
Kura ta ’ anemija sintomatika indotta mill- kimoterapija f’ pazjenti bil- kanċer:
NeoRecormon should be administered by the subcutaneous route to patients with anaemia (e. g. haemoglobin concentration ≤ 10g/ dl (6.2 mmol/ l)).
NeoRecormon għandu jingħata minn taħt il- ġilda lill- pazjenti b’ anemija (e. ż. konċentrazzjoni ta ’ l - emoglobina ≤ 10 g/ dl (6. 2 mmol/ l)).
Treatment for increasing the amount of autologous blood:
17 Kura biex jiżdied id- demm li jagħmel il- pazjent innifsu:
16 This amount should be that quantity which is expected to be sufficient to avoid homologous blood transfusions.
Dan l- ammont għandu jkun dik il- kwantita` li hija mistennija li tkun biżżejjed biex tiġi evitata trasfużjoni ta ’ demm omologa.
4.3 Contraindications
18 4. 3 Kontra- indikazzjonijiet
Poorly controlled hypertension.
Pressjoni għolja mhux kontrollata tajjeb
17 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.
19 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.
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 ta ’ 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.
It is therefore recommended to monitor blood pressure, in particular in the initial treatment phase in cancer patients.
Għalhekk huwa rakkomandat li tiġi sorveljata l- pressjoni tad- demm, speċjalment fil- fażi tal- bidu tal- kura f’ pazjenti bil - kanċer.
For use of NeoRecormon in an autologous predonation programme, the official guidelines on principles of blood donation must be considered, in particular:
20 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];
19 This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i. e. essentially “ sodium- free”.
Dan il- prodott mediċinali fih inqas minn 1 mmol ta ’ sodju (23 mg) kull doża, 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.
21 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.
20 Epoetin beta treatment-related headache and hypertension which can be treated with drugs are common (> 1%, < 10%) (see section 4.4).
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).
The incidences of undesirable effects in clinical trials, considered related to treatment with NeoRecoromon are shown in the table below.
22 L- inċidenza ta ’ effetti mhux mixtieqa fi studji kliniċi, kkunsidrati relatati ma ’ kura b’ NeoRecoromon huma mniżżla fit- tabella taħt.
21 Pharmacotherapeutic group: antianaemic, ATC code:
Kategorija farmakoterapewtika: anti- anemiku, Kodiċi ATC:
Benzyl alcohol, Benzalkonium chloride, Water for injections
Benzyl alcohol, Benzalkonium chloride, Ilma għall- injezzjonijiet.
23 Chemical and physical in-use stability of the reconstituted solution has been demonstrated for one month at 2°C-8°C.
Stabilità kimika u fiżika waqt l- użu tas- soluzzjoni rikostitwita kienet demostrata għal xahar f’ temperatura ta ’ 2°C - 8°C.
From a microbiological point of view, once opened, the reconstituted solution may be stored for maximum of one month at 2°C-8°C.
Mill- aspett mikrobijoloġiku, la darba tinfetaħ, is- soluzzjoni rikostitwita tista ’ tinħażen sa massimu ta ’ xahar f’ temperatura ta ’ 2°C - 8°C.
Other in-use storage times and conditions are the responsibility of the user.
Kundizzjonijiet oħra ta ’ ħażna waqt l - użu huma r- responsabbiltà ta ’ minn qed juża ’ l- prodott.
Lyophilisate (100,000 IU) for solution for injection in a vial (type 1 glass) with a stopper (teflonised rubber) and 5 ml of solvent in an ampoule (type 1 glass), with one reconstitution and withdrawal device with one needle (21G2) and one disposable syringe (polypropylene and polyethylene) (5 ml).
Lajofiliżat (100, 000 IU) għal soluzzjoni għall- injezzjoni f’ kunjett (ħġieġ tip I) b’ tapp (lasktu teflonizzat) u 5 ml ta ’ solvent f’ ampulla (ħġieġ tip I), bi strument wieħed għar- rikostituzzjoni u biex tiġbed, labra waħda (21G2), u siringa li tintrema (polypropylene u polyethylene) (5 ml).
This is dissolved with the contents of the accompanying solvent ampoule by means of a reconstitution and withdrawal device according to the instructions given below.
Jista ’ jkunu injettati biss dawk is -
Only solutions which are clear or slightly opalescent, colourless and practically free of visible particles may be injected.
25 soluzzjonijiet li jkun ċari jew kemm xejn ikanġu, bla kulur u li prattikament mingħajr frak li jidhru.
(4) Take the reconstitution and withdrawal device (which allows sterile air exchange) out of the blister and remove the protective cover from the spike.
(4) Neħħi l- apparat għar- rikostituzzjoni u ġbid (li jippermetti tibdil sterilizzat ta ’ l- arja) minn ġol- folja u neħħi l- għatu ta ’ protezzjoni minn mal- ponta.
24 Preparation of a single injection (1) Before withdrawing each dose disinfect the rubber seal of the device with alcohol.
Il- preparazzjoni għal injezzjoni waħdanija (1) Qabel tiġbed kull doża iddiżinfetta s- siġill tal- lasktu ta ’ l- apparat bl- alkoħol.
NeoRecormon 10,000 IU Lyophilisate and solvent for solution for injection in cartridge (10,000 IU/ ml)
NeoRecormon 10, 000 IU Lajofiliżat u solvent għal soluzzjoni għall- injezzjoni fi skartoċċ (10, 000 IU/ ml)
One cartridge contains 10,000 international units (IU) corresponding to 83 micrograms epoetin beta* (recombinant human erythropoietin) and 1 ml solvent (water for injections with benzyl alcohol and benzalkonium chloride as preservatives).
Skartoċċ wieħed fih 10, 000 IU li jikkorrispondu għal 83 mikrogrammi epoetin beta * (eritropoetin rikombinanti uman) u 1 ml solvent (ilma għall- injezzjonijiet bl- alkoħol benżiliku u klorur tal - benżalkonju bħala preservattivi).
One ml solution for injection contains 10,000 IU epoetin beta.
Kull ml ta ’ soluzzjoni għall- injezzjoni fiha 10, 000 IU epoetin beta.
Phenylalanine (up to 0.5 mg/ cartridge) Sodium (less than 1 mmol/ cartridge) Benzyl alcohol (up to 4 mg/ cartridge)
Phenylalanine (sa 5. 0 mg/ skartoċċ) Sodju (inqas minn 1 mmol/ skartoċċ) Benzyl alcohol (sa 4 mg/ skartoċċ)
- Treatment of symptomatic anaemia associated with chronic renal failure (CRF) in adult and
Kura ta ’ anemija sintomatika assoċjata ma ’ insuffiċjenza kronika tal- kliewi (CRF) f’ pazjenti
- Increasing the yield of autologous blood from patients in a pre-donation programme.
- L- użu tiegħu f’ dan il- każ għandu jkun meqjus skond iż- żjieda fir- riskju rrappurtat ta ’
Its use in this indication must be balanced against the reported increased risk of thromboembolic events.
avvenimenti tromboembolitiċi.
Treatment should only be given to patients with moderate anaemia (Hb 10 - 13 g/ dl [6.21 - 8.07 mmol/ l], no iron deficiency) if blood conserving procedures are not available or insufficient when the scheduled major elective surgery requires a large volume of blood (4 or more units of blood for females or 5 or more units for males).
Il- kura għandha tingħata biss lil pazjenti b’ anemija moderata (Hb 10 - 13 g/ dl [6. 21 - 8. 07 mmol/ l], mingħajr defiċenza ta ’ ħadid) jekk ma jkunx hemm proċeduri biex jippreservaw id- demm jew jekk dawn il- proċeduri ma jkunux tajbin biżżejjed meta trid issir operazzjoni maġġura, mhux urġenti li jkollha bżonn ammonti kbar ta ’ demm (4 unitajiet jew iżjed għan- nisa jew 5 jew iżjed għall- irġiel).
As anaphylactoid reactions were observed in isolated cases, it is recommended that the first dose be administered under medical supervision.
Minħabba li kien hemm reazzjonijiet anafilattiċi f’ każi iżolati, huwa rakkomandata li l- ewwel doża tingħata taħt sorveljanza medika.
The prepared solution is administered subcutaneously.
Is- soluzzjoni ippreparata għandha tingħata minn taħt il- ġilda.
26 Treatment of symptomatic anaemia in adult and paediatric chronic renal failure patients:
28 Kura ta ’ anemija sintomatika f’ pazjenti adulti u pedjatriċi b’ insuffiċjenza kronika tal- kliewi:
NeoRecormon should be administered subcutaneously in order to increase haemoglobin to not greater than 12 g/ dl (7.5 mmol/ l).
NeoRecormon għandu jingħata minn taħt il- ġilda sabiex iżid l- emoglobina sa mhux aktar minn 12 g/ dl (7. 5 mmol/ l).
Correction phase The initial dosage is 3 x 20 IU/ kg body weight per week.
Fażi ta ’ korrezzjoni Id- doża tal- bidu hi 3 × 20 IU/ kg piż tal- ġisem fil- ġimgħa.
The weekly dose can also be divided into daily doses.
Id- dożaġġ jista ’ jiġi miżjud kull 4 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.
The maximum dose should not exceed 720 IU/ kg per week.
L- ogħla doża m’ għandhiex taqbeż 720 IU/ kg fil- ġimgħa.
The weekly dose can be given as one injection per week or in divided doses three or seven times per week.
Meta jingħata minn taħt il- ġilda, id- doża ta ’ kull ġimgħa tista ’ tingħata bħala injezzjoni waħda fil - ġimgħa jew maqsuma f’ dożi, tlieta jew seba ’ darbiet fil- ġimgħa.
Treatment with NeoRecormon is normally a long-term therapy.
Kura b’ NeoRecormon normalment hija terapija fit- tul.
Treatment of symptomatic chemotherapy-induced anaemia in cancer patients:
29 Kura ta ’ anemija sintomatika indotta mill- kimoterapija f’ pazjenti bil- kanċer:
27 The weekly dose can be given as one injection per week or in divided doses 3 to 7 times per week.
Id- doża ta ’ kull ġimgħa tista ’ tingħata bħala injezzjoni waħda kull ġimgħa jew f’ dożi mqassmin bejn 3 u 7 darbiet fil- ġimgħa.
The recommended initial dose is 30,000 IU per week (corresponding to approximately 450 IU/ kg body weight per week, based on an average weighted patient).
Id- doża tal- bidu rakkomandata hi 30. 000 IU kull ġimgħa (tikkorrispondi għal madwar 450 IU/ kg piż tal- ġisem kull ġimgħa, bbażata fuq pazjent ta ’ piż medju).
If the haemoglobin value has not increased by at least 1 g/ dl (0.62 mmol/ l), a doubling of the weekly dose should be considered.
Jekk il- valur tal- emoglobina ma żdiedx b’ mill- inqas 1 g/ dl (0. 62 mmol/ l), wieħed għandu jikkunsidra li jirdoppja d- doża ta ’ kull ġimgħa.
If, after 8 weeks of therapy, the haemoglobin value has not increased by at least 1 g/ dl (0.62 mmol/ l), response is unlikely and treatment should be discontinued.
Jekk wara 8 ġimgħat ta ’ terapija il- valur ta’ emoglobina ma żdiedx b’ mill- inqas 1 g/ dl (0. 62 mmol/ l), hemm probabbilta ’ li l- pazjent mhux se jirrispondi u l- kura għandha titwaqqaf.
Treatment for increasing the amount of autologous blood:
Kura biex jiżdied id- demm li jagħmel il- pazjent innifsu:
This amount should be that quantity which is expected to be sufficient to avoid homologous blood transfusions.
Dan l- ammont għandu jkun dik il- kwantita` li hija mistennija li tkun biżżejjed biex tiġi evitata trasfużjoni ta ’ demm omologa.
The required amount of pre-donated blood is expressed in units whereby one unit in the nomogram is equivalent to 180 ml red cells.
30 L- ammont meħtieġ ta ’ demm mogħti minn qabel hu espress f’ unitajiet fejn unità waħda fin - nomogramma hija ekwivalenti għal 180 ml ċelluli ħomor.
28 Endogenous red cell reserve = blood volume [ml] x (PCV - 33) ÷ 100
Riserva ta ’ ċelluli ħomor endoġeni = volum tad- demm [ml] × (PCV - 33) ÷ 100 Nisa: volum tad- demm [ml] = 41 [ml/ kg] × piż tal- ġisem [kg] + 1200 [ml] Irġiel: volum tad- demm [ml] = 44 [ml/ kg] × piż tal- ġisem [kg] + 1600 [ml] (piż tal- ġisem ≥ 45 kg)
Women:
c:
Men:
:
blood volume [ml] = 41 [ml/ kg] x body weight [kg] + 1200 [ml] blood volume [ml] = 44 [ml/ kg] x body weight [kg] + 1600 [ml]
c:
The indication for NeoRecormon treatment 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.
i. v
Female patients
8 Ü/ k
Male patients
3 TÜ orm
Required amount of pre-donated blood [units]
s.
Endogenous red cell reserve [ml]
s. c 50 ec 0 40 / kg
Endogenous red cell reserve [ml]
1 oR
The single dose thus determined is administered
i
twice weekly over 4 weeks.
: 4
The maximum dose
i. v 00T jittie
should not exceed 1200 IU/ kg body weight per week.
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.
NeoRecormon in cartridge contains benzyl alcohol as a preservative and must therefore not be given to infants or young children up to three years old.
NeoRecormon fl- iskartoċċ fih benzyl alcohol bħala preservattiv, u għalhekk m’ għandux jingħata lil trabi jew tfal ta ’ taħt it- tliet snin.
4.4 Special warnings and precautions for use
31 4. 4 Avviżi speċjali u prekawzjonijiet għall- użu
29 Severe aluminium overload due to treatment of renal failure may compromise the effectiveness of NeoRecormon.
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.
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.
Factors that should be considered
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.
30 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)
Fatturi li għandhom jiġu kkunsidrati f’ din il- valutazzjoni għandhom jinkludu t- tip ta ’ tumur u l- istadju tiegħu; il- grad ta ’ l- anemija; it- tul mistenni tal- ħajja; l- ambjent li fih qed jiġi kkurat il- pazjent; u l- preferenza tal- pazjent (ara sezzjoni 5. 1)
For use of NeoRecormon in an autologous predonation programme, the official guidelines on principles of blood donation must be considered, in particular:
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.
33 L- użu ħażin minn persuni f’ saħħithom jista ’ jwassal għal żjieda eċċessiva fil- volum ta ’ ċelluli ppakjati.
NeoRecormon in cartridge contains up to 0.5 mg phenylalanine/ cartridge as an excipient.
NeoRecormon jista ’ jkun fih sa 0. 5 mg ta ’ phenylalanine/ kunjett bħala sustanza mhux attiva.
NeoRecormon in cartridge contains up to 4 mg benzyl alcohol which may cause toxic reactions and anaphylactoid reactions in infants and children up to 3 years old.
NeoRecormon fi skartoċċ fih sa 4 mg benzyl alcohol li jista ’ jikkawża reazzjonijiet tossiċi u anafilaktojdi fi trabi u tfal b’ età ta ’ 3 snin jew anqas.
This medicinal product contains less than 1 mmol sodium (23 mg) per cartridge, i. e. essentially “ sodium-free”.
Dan il- prodott mediċinali fih inqas minn 1 mmol ta ’ sodju (23 mg) kull skartoċċ, i. e. essenzjalment “ bla sodju ”.
31 4.6 Pregnancy and lactation
4. 6 Tqala u treddigħ
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.
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.
34 L- inċidenza ta ’ effetti mhux mixtieqa fi provi kliniċi, kkunsidrati bħala relatati ma ’ kura b’ NeoRecoromon huma mniżżla fit- tabella taħt.
- Patients with cancer
- Pazjenti bil- kanċer
Epoetin beta treatment-related headache and hypertension which can be treated with drugs are common (> 1%, < 10%) (see section 4.4).
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).
32 The incidences of undesirable effects in clinical trials, considered related to treatment with NeoRecoromon are shown in the table below.
L- inċidenza ta ’ effetti mhux mixtieqa fi studji kliniċi, kkunsidrati relatati ma ’ kura b’ NeoRecoromon huma mniżżla fit- tabella taħt.
Pharmacotherapeutic group: antianaemic, ATC code:
Kategorija farmakoterapewtika: anti- anemiku, Kodiċi ATC:
33 After administration of epoetin beta, the number of erythrocytes, the Hb values and reticulocyte counts increase as well as the 59Fe-incorporation rate.
Wara l- amministrazzjoni ta ’ epoetin beta, in- numru ta ’ eritroċiti, il- valuri tal- Hb u l- għadd ta ’ retikuloċiti żdiedu, flimkien mar- rata ta ’ inkorporazzjoni ta ’ 59Fe.
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.
36 kumplikazzjonijiet relatati bejn dawk li ngħataw eritropoetin rikombinanti uman u dawk fil- grupp ta ’ kontroll.
34 After subcutaneous administration of epoetin beta to uraemic patients, the protracted absorption results in a serum concentration plateau, whereby the maximum concentration is reached after an average of 12 - 28 hours.
Wara għotja minn taħt il- ġilda ta ’ epoetin beta lil pazjenti uremiċi, assorbiment imtawwal irriżulta f’ konċentrazzjoni fissa fis- serum, fejn l- ogħla konċentrazzjoni tintlaħaq wara medja ta ’ bejn 12 u 28 siegħa.
Urea, Sodium chloride, Polysorbate 20, Sodium dihydrogen phosphate, Disodium hydrogen phosphate, Calcium chloride, Glycine, L-Leucine, L-Isoleucine, L-Threonine, L-Glutamic acid, L-Phenylalanine.
Urea, Sodium chloride, Polysorbate 20, Sodium dihydrogen phosphate,
Chemical and physical in-use stability of the reconstituted solution has been demonstrated for one month at 2°C-8°C.
Sentejn Stabilità kimika u fiżika waqt l- użu tas- soluzzjoni rikostitwita kienet demostrata għal xahar f’ temperatura ta ’ 2°C - 8°C.
Keep the cartridge in the outer carton, in order to protect from light.
Żomm l- iskartoċċ fil- kartuna ta ’ barra, tilqa ’ protett mid- dawl.
35 For the purpose of ambulatory use, the patient may remove the cartridge not yet inserted into the Reco-Pen from the refrigerator and store it at room temperatur (not above 25°C) for one single period of up to 5 days.
Għall- skop ta ’ użu ambulatorju, il- pazjent jista ’ jneħħi l- iskartoċċ li ma jkunx għadu ddaħħal fir- Reco - Pen mill- friġġ u jżommu f’ temperatura ambjentali (mhux aktar minn 25 °C), għall- perjodu wieħed ta ’ mhux aktar minn ħamest ijiem.
After insertion into the Reco-Pen, the cooling chain may only be interrupted for administration of the product.
Wara li jkun iddaħħal ġor- Reco- Pen, il- proċess tat- tkessieħ jista ’ jitwaqqaf biss biex jingħata l- prodott.
Pack sizes of 1 or 3.
Lajofiliżat (10, 000 IU) u solvent (1 ml) għal soluzzjoni għall- injezzjoni fi skartoċċ b’ żewġ kompartimenti għal Reco- Pen (ħġieġ tip I) bid- diska ta ’ quddiem magħmula minn materjal tal- lasktu ta ’ kwalità farmaċewtika u b’ għotien (lasktu teflonizzat).
Not all pack sizes may be marketed.
Daqs tal- pakkett ta ’ 1 jew 3.
This NeoRecormon presentation is a two-chamber cartridge containing lyophilisate for solution for injection and preserved solution.
Din il- forma ta ’ NeoRecormon hija skartoċċ b’ żewġ kompartamenti li jkun fih lajofiliżat għal soluzzjoni għall- injezzjoni u soluzzjoni ippreservata.
The ready-to-use solution is prepared by inserting the cartridge into the Reco-Pen.
Is- soluzzjoni lesta biex tintuża hija ppreparata billi jiddaħħal l- iskartoċċ ġor- Reco- Pen.
Prior to this a needle should be attached to the Reco-Pen.
Qabel dan, għandha titwaħħal labra mar- Reco- Pen.
Only solutions which are clear or slightly opalescent, colourless and practically free of visible particles may be injected.
Jista ’ jkunu njettati biss soluzzjonijiet li jkunu ċari jew kemmxejnimdardra, bla kulur u prattikament mingħajr frak li jidhru.
Please observe the instructions for use which are delivered with the Reco-Pen.
Jekk jogħġbok osserva l- istruzzjonijiet għall- użu li jiġu mar- Reco- Pen
NeoRecormon 20,000 IU Lyophilisate and solvent for solution for injection in cartridge (20,000 IU/ ml)
NeoRecormon 20, 000 IU Lajofiliżat u solvent għal soluzzjoni għall- injezzjoni fi skartoċċ (20, 000 IU/ ml)
One cartridge contains 20,000 international units (IU) corresponding to 166 micrograms epoetin beta* (recombinant human erythropoietin) and 1 ml solvent (water for injections with benzyl alcohol and benzalkonium chloride as preservatives).
Skartoċċ wieħed fih 20, 000 IU li jikkorrispondu għal 166 mikrogrammi epoetin beta * (eritropoetin rikombinanti uman) u 1 ml solvent (ilma għall- injezzjonijiet bl- alkoħol benżiliku u klorur tal - benżalkonju bħala preservattivi).
One ml solution for injection contains 20,000 IU epoetin beta.
Kull ml ta ’ soluzzjoni għall- injezzjoni fiha 20, 000 IU epoetin beta.
37 Treatment of symptomatic anaemia in adult and paediatric chronic renal failure patients:
40 Kura ta ’ anemija sintomatika f’ pazjenti adulti u pedjatriċi b’ insuffiċjenza kronika tal- kliewi:
Treatment with NeoRecormon is divided into two stages.
Kura b’ NeoRecormon hija maqsuma f’ żewġ stadji.
Anaemia symptoms and sequelae may vary with age, gender, and overall burden of disease; a physician’ s evaluation of the individual patient ’ s clinical course and condition is necessary.
41 effett globali tal- marda; valutazzjoni ta ’ tabib tal- progressjoni u l- kundizzjoni klinika tal- pazjent individwali hija neċessarja.
38 The weekly dose can be given as one injection per week or in divided doses 3 to 7 times per week.
Id- doża ta ’ kull ġimgħa tista ’ tingħata bħala injezzjoni waħda kull ġimgħa jew f’ dożi mqassmin bejn 3 u 7 darbiet fil- ġimgħa.
39 Endogenous red cell reserve = blood volume [ml] x (PCV - 33) ÷ 100
Riserva ta ’ ċelluli ħomor endoġeni = volum tad- demm [ml] × (PCV - 33) ÷ 100 Nisa: volum tad- demm [ml] = 41 [ml/ kg] × piż tal- ġisem [kg] + 1200 [ml] Irġiel: volum tad- demm [ml] = 44 [ml/ kg] × piż tal- ġisem [kg] + 1600 [ml] (piż tal- ġisem ≥ 45 kg)
Women:
00 kg:
blood volume [ml] = 41 [ml/ kg] x body weight [kg] + 1200 [ml] blood volume [ml] = 44 [ml/ kg] x body weight [kg] + 1600 [ml]
Ü /
The indication for NeoRecormon treatment 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.
00
Female patients
T / kg on
Male patients
8 Ü /
Required amount of pre-donated blood [units]
c:
Endogenous red cell reserve [ml]
3 TÜ orm
Endogenous red cell reserve [ml]
1 oR e
The single dose thus determined is administered
i. v
twice weekly over 4 weeks.
4
The maximum dose
i. v 00T jittie i. v: 2 x
NeoRecormon in cartridge contains benzyl alcohol as a preservative and must therefore not be given to infants or young children up to three years old.
NeoRecormon fl- iskartoċċ fih benzyl alcohol bħala preservattiv, u għalhekk m’ għandux jingħata lil trabi jew tfal ta ’ taħt it- tlitt snin.
NeoRecormon should be used with caution in the presence of refractory anaemia with excess blasts in transformation, epilepsy, thrombocytosis, and chronic liver failure.
Wieħed
Folic acid and vitamin B12 deficiencies should be ruled out as they reduce the effectiveness of NeoRecormon.
43 għandu jiżgura li m’ hemmx defiċjenza ta ’ folic acid u vitamina B12 għax dawn inaqqsu l- effikaċja ta ’ NeoRecormon.
40 Severe aluminium overload due to treatment of renal failure may compromise the effectiveness of NeoRecormon.
Togħbija severa ta ’ aluminju minħabba kura ta ’ insuffiċjenza tal- kliewi tista ’ tnaqqas l- effikaċja ta ’ NeoRecormon.
Pure red cell aplasia caused by neutralising anti-erythropoietin antibodies has been reported in association with erythropoietin therapy, including NeoRecormon.
Aplasja pura taċ- ċelluli ħomor ikkawżata minn antikorpi newtralizzanti kontra l - eritropoetin, kienet irrappurtata f’ assoċjazzjoni ma ’ terapija b ’ eritropoetin, inkluż NeoRecormon.
The decision to administer recombinant erythropoietins should be based on a benefit-risk assessment with the participation of the individual
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.
NeoRecormon in cartridge contains up to 4 mg benzyl alcohol which may cause toxic reactions and anaphylactoid reactions in infants and children up to 3 years old.
45 NeoRecormon fi skartoċċ fih sa 4 mg benzyl alcohol li jista ’ jikkawża reazzjonijiet tossiċi u anafilaktojdi fi trabi u tfal b’ età ta ’ 3 snin jew anqas.
42 4.6 Pregnancy and lactation
4. 6 Tqala u treddigħ
43 The incidences of undesirable effects in clinical trials, considered related to treatment with NeoRecoromon are shown in the table below.
L- inċidenza ta ’ effetti mhux mixtieqa fi studji kliniċi, kkunsidrati relatati ma ’ kura b’ NeoRecoromon huma mniżżla fit- tabella taħt.
44 After administration of epoetin beta, the number of erythrocytes, the Hb values and reticulocyte counts increase as well as the 59Fe-incorporation rate.
Wara l- amministrazzjoni ta ’ epoetin beta, in- numru ta ’ eritroċiti, il- valuri tal- Hb u l- għadd ta ’ retikuloċiti żdiedu, flimkien mar- rata ta ’ inkorporazzjoni ta ’ 59Fe.
An individual patient data based meta-analysis, which included data from all 12 controlled clinical studies in anaemic cancer patients conducted with NeoRecormon (n=2301), showed an overall hazard ratio point estimate for survival of 1.13 in favour of controls (95% CI 0.87, 1.46).
48 Meta- analiżi bbażata fuq tagħrif tal- pazjent individwali, li nkludiet tagħrif mit- 12- il studju kliniku kkontrollat kollha, magħmula b’ NeoRecormon f’ pazjenti anemiċi bil- kanċer (n=2301), uriet estimu globali tal- punt tal- proporzjon ta ’ periklu għas- sopravivenza ta ’ 1. 13 favur il- kontrolli (95% CI 0. 87, 1. 46).
45 After subcutaneous administration of epoetin beta to uraemic patients, the protracted absorption results in a serum concentration plateau, whereby the maximum concentration is reached after an average of 12 - 28 hours.
Wara għotja minn taħt il- ġilda ta ’ epoetin beta lil pazjenti uremiċi, assorbiment imtawwal irriżulta f’ konċentrazzjoni fissa fis- serum, fejn l- ogħla konċentrazzjoni tintlaħaq wara medja ta ’ bejn 12 u 28 siegħa.
Urea, Sodium chloride, Polysorbate 20, Sodium dihydrogen phosphate, Disodium hydrogen phosphate, Calcium chloride, Glycine, L-Leucine, L-Isoleucine, L-Threonine, L-Glutamic acid, L-Phenylalanine.
Urea, Sodium chloride, Polysorbate 20, Sodium dihydrogen phosphate, Disodium hydrogen phosphate, Calcium chloride,
Keep the cartridge in the outer carton, in order to protect from light.
Żomm l- iskartoċċ fil- kartuna ta ’ barra, sabiex tilqa ’ mid- dawl.
46 For the purpose of ambulatory use, the patient may remove the cartridge not yet inserted into the Reco-Pen from the refrigerator and store it at room temperatur (not above 25°C) for one single period of up to 5 days.
Għall- skop ta ’ użu ambulatorju, il- pazjent jista ’ jneħħi l- iskartoċċ li ma jkunx għadu ddaħħal fir- Reco - Pen mill- friġġ u jżommu f’ temperatura ambjentali (mhux aktar minn 25 °C), għall- perjodu wieħed ta ’ mhux aktar minn ħamest ijiem.
After insertion into the Reco-Pen, the cooling chain may only be interrupted for administration of the product.
Wara li jkun iddaħħal ġor- Reco- Pen, il- proċess tat- tkessieħ jista ’ jitwaqqaf biss bix jingħata l- prodott.
Lyophilisate (20,000 IU) and solvent (1 ml) for solution for injection in two-chamber cartridge for Reco-Pen (type I glass) with front disk made of rubber material of pharmaceutical quality and with stoppers (teflonised rubber).
Lajofiliżat (20, 000 IU) u solvent (1 ml) għal soluzzjoni għall- injezzjoni fi skartoċċ b’ żewġ kompartimenti għal Reco- Pen (ħġieġ tip I) bid- diska ta ’ quddiem magħmula minn materjal tal- lasktu ta ’ kwalità farmaċewtika u b’ għotien (lasktu teflonizzat).
Pack sizes of 1 or 3.
Daqs tal- pakkett ta ’ 1 jew 3.
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 1TW Ir- Renju Unit
NeoRecormon 60,000 IU Lyophilisate and solvent for solution for injection in cartridge (60,000 IU/ ml)
NeoRecormon 60, 000 IU Lajofiliżat u solvent għal soluzzjoni għall- injezzjoni fi skartoċċ (60, 000 IU/ ml)
One cartridge contains 60,000 international units (IU) corresponding to 498 micrograms epoetin beta* (recombinant human erythropoietin) and 1 ml solvent (water for injections with benzyl alcohol and benzalkonium chloride as preservatives).
Skartoċċ wieħed fih 60, 000 IU li jikkorrispondu għal 498 mikrogrammi epoetin beta * (eritropoetin rikombinanti uman) u 1 ml solvent (ilma għall- injezzjonijiet bl- alkoħol benżiliku u klorur tal - benżalkonju bħala preservattivi).
One ml solution for injection contains 60,000 IU epoetin beta.
Kull ml ta ’ soluzzjoni għall- injezzjoni fiha 60, 000 IU epoetin beta.
48 Treatment of symptomatic anaemia in adult and paediatric chronic renal failure patients:
52 Kura ta ’ anemija sintomatika f’ pazjenti adulti u pedjatriċi b’ insuffiċjenza kronika tal- kliewi:
Treatment of symptomatic chemotherapy-induced anaemia in cancer patients:
53 Il- kura ta ’ anemija sintomatika indotta mill- kimoterapija f’ pazjenti bil- kanċer:
49 The weekly dose can be given as one injection per week or in divided doses 3 to 7 times per week.
Id- doża ta ’ kull ġimgħa tista ’ tingħata bħala injezzjoni waħda kull ġimgħa jew f’ dożi mqassmin bejn 3 u 7 darbiet fil- ġimgħa.
The required amount of pre-donated blood is expressed in units whereby one unit in the nomogram is equivalent to 180 ml red cells.
54 L- ammont meħtieġ ta ’ demm mogħti minn qabel hu espress f’ unitajiet fejn unità waħda fin - nomogramma hija ekwivalenti għal 180 ml ċelluli ħomor.
50 Endogenous red cell reserve = blood volume [ml] x (PCV - 33) ÷ 100
Riserva ta ’ ċelluli ħomor endoġeni = volum tad- demm [ml] × (PCV - 33) ÷ 100 Nisa: volum tad- demm [ml] = 41 [ml/ kg] × piż tal- ġisem [kg] + 1200 [ml] Irġiel: volum tad- demm [ml] = 44 [ml/ kg] × piż tal- ġisem [kg] + 1600 [ml] (piż tal- ġisem ≥ 45 kg)
4.4 Special warnings and precautions for use
55 4. 4 Avviżi speċjali u prekawzjonijiet għall- użu
51 Severe aluminium overload due to treatment of renal failure may compromise the effectiveness of NeoRecormon.
Togħbija severa ta ’ aluminju minħabba kura ta ’ insuffiċjenza tal- kliewi tista ’ tnaqqas l- effikaċja ta ’ NeoRecormon.
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).
Dawn l- antikorpi ntwerew li jirreaġixxu mal- proteini eritopoetiċi kollha, u pazjenti ssuspettati jew ikkonfermati li għandhom antikorpi newtralizzanti kontra l - eritropoetin m’ għandhomx jinqalbu għal NeoRecormon (ara sezzjoni 4. 8).
Misuse by healthy persons may lead to an excessive increase in packed cell volume.
57 L- użu ħażin minn persuni f’ saħħithom jista ’ jwassal għal żjieda eċċessiva fil- volum ta ’ ċelluli ppakjati.
53 4.6 Pregnancy and lactation
4. 6 Tqala u treddigħ
The incidences of undesirable effects in clinical trials, considered related to treatment with NeoRecoromon are shown in the table below.
58 L- inċidenza ta ’ effetti mhux mixtieqa fi provi kliniċi, kkunsidrati bħala relatati ma ’ kura b’ NeoRecoromon huma mniżżla fit- tabella taħt.
54 The incidences of undesirable effects in clinical trials, considered related to treatment with NeoRecoromon are shown in the table below.
L- inċidenza ta ’ effetti mhux mixtieqa fi studji kliniċi, kkunsidrati relatati ma ’ kura b’ NeoRecoromon huma mniżżla fit- tabella taħt.
55 After administration of epoetin beta, the number of erythrocytes, the Hb values and reticulocyte counts increase as well as the 59Fe-incorporation rate.
Wara l- amministrazzjoni ta ’ epoetin beta, in- numru ta ’ eritroċiti, il- valuri tal- Hb u l- għadd ta ’ retikuloċiti żdiedu, flimkien mar- rata ta ’ inkorporazzjoni ta ’ 59Fe.
An individual patient data based meta-analysis, which included data from all 12 controlled clinical studies in anaemic cancer patients conducted with NeoRecormon (n=2301), showed an overall hazard ratio point estimate for survival of 1.13 in favour of controls (95% CI 0.87, 1.46).
60 Meta- analiżi bbażata fuq tagħrif tal- pazjent individwali, li nkludiet tagħrif mit- 12- il studju kliniku kkontrollat kollha, magħmula b’ NeoRecormon f’ pazjenti anemiċi bil- kanċer (n=2301), uriet estimu globali tal- punt tal- proporzjon ta ’ periklu għas- sopravivenza ta ’ 1. 13 favur il- kontrolli (95% CI 0. 87, 1. 46).
56 After subcutaneous administration of epoetin beta to uraemic patients, the protracted absorption results in a serum concentration plateau, whereby the maximum concentration is reached after an average of 12 - 28 hours.
Wara għotja minn taħt il- ġilda ta ’ epoetin beta lil pazjenti uremiċi, assorbiment imtawwal irriżulta f’ konċentrazzjoni fissa fis- serum, fejn l- ogħla konċentrazzjoni tintlaħaq wara medja ta ’ bejn 12 u 28 siegħa.
Lyophilisate:
Lajofiliżejt:
57 For the purpose of ambulatory use, the patient may remove the cartridge not yet inserted into the Reco-Pen from the refrigerator and store it at room temperatur (not above 25°C) for one single period of up to 5 days.
Għall- skop ta ’ użu ambulatorju, il- pazjent jista ’ jneħħi l- iskartoċċ li ma jkunx għadu ddaħħal fir- Reco - Pen mill- friġġ u jżommu f’ temperatura ambjentali (mhux aktar minn 25 °C), għall- perjodu wieħed ta ’ mhux aktar minn ħamest ijiem.
Pack sizes of 1 or 3.
Lajofiliżejt (60, 000 IU) u solvent (1 ml) għal soluzzjoni għall- injezzjoni fi skartoċċ b’ żewġ kompartimenti għal Reco- Pen (ħġieġ tip I) bid- diska ta ’ quddiem magħmula minn materjal tal- lasktu ta ’ kwalità farmaċewtika u b’ għotien (lasktu teflonizzat).
This NeoRecormon presentation is a two-chamber cartridge containing lyophilisate for solution for injection and preserved solution.
Din il- forma ta ’ NeoRecormon hi skartoċċ b’ żewġ kompartamenti li jkun fih lajofiliżejt għal taħlita likwida għall- injezzjoni u soluzzjoni ippreservata.
The ready-to-use solution is prepared by inserting the cartridge into the Reco-Pen.
Is- soluzzjoni lesta biex tintuża hi ippreparata billi jiddaħħal l- iskartoċċ ġor- Reco- Pen.
Only solutions which are clear or slightly opalescent, colourless and practically free of visible particles may be injected.
Jistgħu ikunu ijjettati biss taħlitiet likwidi li jkunu ċari jew kemm kemm imdardrin, bla kulur u prattikament mingħajr partiċelli jidhru.
NeoRecormon 500 IU solution for injection in pre-filled syringe
NeoRecormon 500 IU soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest
One pre-filled syringe with 0.3 ml solution for injection contains 500 international units (IU) corresponding to 4.15 micrograms epoetin beta* (recombinant human erythropoietin).
Siringa waħda mimlija għal- lest b’ 0. 3 ml soluzzjoni għall- injezzjoni li fiha 500 unità internazzjonali (IU) li jikkorrespondu għal 4. 15 mikrogrammi epoetin beta * (eritropoetin rikombinanti uman).
One ml solution for injection contains 1667 IU epoetin beta.
Kull ml ta ’ soluzzjoni għall- injezzjoni fiha 1667 IU epoetin beta.
Phenylalanine (up to 0.3 mg/ syringe) Sodium (less than 1 mmol/ syringe)
Phenylalanine (sa 0. 3 mg/ siringa) Sodju (inqas minn 1 mmol/ siringa)
Colourless, clear to slightly opalescent solution.
Soluzzjoni bla kulur, ċara għal kemmxejn tkanġi.
- Prevention of anaemia of prematurity in infants with a birth weight of 750 to 1500 g and a
- Prevenzjoni ta ’ anemija ta ’ prematurita` fi trabi li twieldu b’ piż minn 750 sa 1500 g u b’ eta`
gestational age of less than 34 weeks.
ġestazzjonali ta ’ inqas minn 34 ġimgħa
- Increasing the yield of autologous blood from patients in a pre-donation programme.
-
Treatment should only be given to patients with moderate anaemia (Hb 10 - 13 g/ dl [6.21 - 8.07 mmol/ l], no iron deficiency) if blood conserving procedures are not available or insufficient when the scheduled major elective surgery requires a large volume of blood (4 or more units of blood for females or 5 or more units for males).
Il- kura għandha tingħata biss lill- pazjenti b’ anemija moderata (Hb 10 - 13 g/ dl [6. 21 - 8. 07 mmol/ l], mingħajr defiċenza ta ’ ħadid) jekk ma jkunx hemm proċeduri biex jippreservaw id- demm jew jekk dawn il- proċeduri ma jkunux tajbin biżżejjed meta trid issir operazzjoni maġġura, mhux urġenti li jkollha bżonn ammonti kbar ta ’ demm (4 unitajiet jew iżjed għan- nisa jew 5 unitajiet jew iżjed għall- irġiel).
As anaphylactoid reactions were observed in isolated cases, it is recommended that the first dose be administered under medical supervision.
Minħabba li kien hemm reazzjonijiet anafilattiċi f’ każijiet iżolati, huwa rakkomandat li l- ewwel doża tingħata taħt sorveljanza medika.
The NeoRecormon pre-filled syringe is ready for use.
Is- siringa mimlija għal- lest b’ NeoRecormon hija lesta biex tintuża.
Only solutions which are clear or slightly opalescent, colourless and practically free of visible particles may be injected.
Jistgħu jintużaw biss dawk is - soluzzjonijiet li jkunu ċari jew kemmxejn imdardar, bla kulur u li prattikament mingħajr frak li jidhru.
NeoRecormon in pre-filled syringe is a sterile but unpreserved product.
NeoRecormon ġo siringa mimlija għal- lest hu prodott sterili imma mhux ippreservat.
Under no circumstances should more than one dose be administered per syringe; the medicinal product is for single use only.
Qatt m’ għandha tingħata iktar minn doża waħda minn kull siringa; il- prodott mediċinali huwa għall- użu ta ’ darba biss.
Treatment of symptomatic anaemia in adult and paediatric chronic renal failure patients:
64 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.
59 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 dosage may be increased every 4 weeks by 3 x 20 IU/ kg and week if the increase of Hb is not adequate (< 0.25 g/ dl per week).
Id- dożaġġ jista ’ jiġi miżjud kull 4 ġimgħat b’ 3 × 20 IU/ kg u ġimgħa jekk iż- żjieda fl- Hb ma tkunx biżżejjed (< 0. 25 g/ dl kull ġimgħa).
The weekly dose can also be divided into daily doses.
Id- doża ta ’ kull ġimgħa tista ’ wkoll tinqasam f’ dożi ta ’ kuljum.
- three times per week - and by further increments of 20 IU/ kg if needed, three times per week,
Id- dożaġġ jista ’ jiġi miżjud wara 4 ġimgħat għal 80 IU/ kg – tliet darbiet fil- ġimgħa – u jekk ikun hemm bżonn, b’ żidiet oħra ta ’ 20 IU/ kg tliet darbiet fil- ġimgħa, b’ xahar bejn żjieda u oħra.
Results of clinical studies in children have shown that, on average, the younger the patients, the higher the NeoRecormon doses required.
65 Riżultati kliniċi fit- tfal urew li, ġeneralment iktar ma jkunu żgħar il- pazjenti iktar ikun hemm bżonn ta ’ dożi ta ’ NeoRecormon għoljin.
60 Prevention of anaemia of prematurity:
Prevenzjoni ta ’ anemija ta ’ prematurità:
The solution is administered subcutaneously at a dose of 3 x 250 IU/ kg b. w. per week.
Is- soluzzjoni rikostitwita tingħata minn taħt il- ġilda b’ doża ta ’ 3 × 250 IU/ kg piż tal- ġisem kull ġimgħa.
Treatment with NeoRecormon should start as early as possible, preferably by day 3 of life.
Il- kura b’ NeoRecormon għanda tinbeda kmieni kemm jista ’ jkun, preferibilment mat- tielet jum tal- ħajja.
Premature infants who have already been transfused by the start of treatment with NeoRecormon are not likely to benefit as much as untransfused infants.
Trabi li twieled qabel iż- żmien li diġa saritilhom trasfużjoni qabel ma nbditilhom il- kura b’ NeoRecormon mhux mistennija li jibbenefikaw daqs trabi li ma saritilhomx trasfużjoni.
The treatment should last for 6 weeks.
Il- kura għandha ddum 6 ġimgħat.
The weekly dose can be given as one injection per week or in divided doses 3 to 7 times per week.
Id- doża ta ’ kull ġimgħa tista ’ tingħata bħala injezzjoni waħda kull ġimgħa jew tinqasam f’ dożi ta ’ 3 sa 7 darbiet fil- ġimgħa.
The recommended initial dose is 30,000 IU per week (corresponding to approximately 450 IU/ kg body weight per week, based on an average weighted patient).
Id- doża tal- bidu rakkomandata hi 30, 000 IU kull ġimgħa (tikkorrispondi għal madwar 450 IU/ kg piż tal- ġisem kull ġimgħa ibbażata fuq pazjent ta ’ piż medju).
If, after 4 weeks of therapy, the haemoglobin value has increased by at least 1 g/ dl (0.62 mmol/ l), the current dose should be continued.
Jekk wara 4 ġimgħat ta ’ terapija il- valur ta ’ emoglobina żdied b’ ta ’ l- inqas 1 g/ dl (0. 62 mmol/ l), id - doża li tkun qed tingħata għandha titkompla.
If the haemoglobin value has not increased by at least 1 g/ dl (0.62 mmol/ l), a doubling of the weekly dose should be considered.
Jekk il- valur ta ’ emoglobina ma żdiedx b’ ta ’ l- inqas 1 g/ dl (0. 62 mmol/ l), wieħed għandu jikkunsidra li jirdoppja d- doża ta ’ kull ġimgħa.
If, after 8 weeks of therapy, the haemoglobin value has not increased by at least 1 g/ dl (0.62 mmol/ l), response is unlikely and treatment should be discontinued.
Jekk wara 8 ġimgħat ta ’ terapija il- valur ta ’ emoglobina ma żdiedx b’ ta ’ l- inqas 1 g/ dl (0. 62 mmol/ l), rispons mhux probabbli u l- kura għandha titwaqqaf.
The therapy should be continued up to 4 weeks after the end of chemotherapy.
It- terapija għandha titkompla sa 4 ġimgħat wara t- tmiem tal- kimoterapija.
If the rise in haemoglobin is greater than 2 g/ dl (1.3 mmol/ l) in 4 weeks, the dose should be reduced by 25 to 50%.
Jekk iż- żjieda fl- emoglobina tkun aktar minn 2 g/ dl (1. 3 mmol/ l) f’ 4 ġimgħat, id- doża għandha titnaqqas b’ 25 sa 50%.
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.
66 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.
61 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:
blood volume [ml] = 41 [ml/ kg] x body weight [kg] + 1200 [ml] blood volume [ml] = 44 [ml/ kg] x body weight [kg] + 1600 [ml]
d
(body weight ≥ 45 kg)
00 / kg d 0
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.
i
Required amount of pre-donated blood [units]
i. v 00 jitt: 2
4.3 Contraindications
67 4. 3 Kontra- indikazzjonijiet
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.
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.
62 4.4 Special warnings and precautions for use
4. 4 Avviżi speċjali u prekawzjonijiet għall- użu