qanastek/EMEA-V3 huggingface dataset:
NeoRecormon Multidose contains benzyl alcohol as a preservative and must therefore not be given to infants or young children up to three years old.
NeoRecormon Multidose fih benzyl alcohol bħala preservattiv, u għalhekk m’ għandux jingħata lil trabi jew tfal ta ’ taħt it- tliet snin.
5 4.4 Special warnings and precautions for use
4. 4 Avviżi speċjali u prekawzjonijiet għall- użu
NeoRecormon should be used with caution in the presence of refractory anaemia with excess blasts in transformation, epilepsy, thrombocytosis, and chronic liver failure.
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.
Folic acid and vitamin B12 deficiencies should be ruled out as they reduce the effectiveness of NeoRecormon.
Wieħed għandu jiżgura li m’ hemmx defiċjenza ta ’ folic acid u vitamina B12 għax dawn inaqqsu l- effikaċja ta ’ NeoRecormon.
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.
Biex tkun żgurata l- formazzjoni effettiva taċ- ċelluli tad- demm ħomor, għandu jkun evalwat l- istat tal - ħadid għal kull pazjent qabel u waqt il- kura, u jista ’ jkun hemm bżonn ta ’ terapija supplimentari bil - ħadid li għandha tingħata skond il- linji gwida tat- terapija.
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.
The indication for NeoRecormon treatment 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.
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.
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).
In chronic renal failure patients an increase in blood pressure or aggravation of existing hypertension, especially in cases of rapid PCV increase can occur.
F’ pazjenti b’ insuffiċjenza kronika tal- kliewi, speċjalment f’ każijiet ta ’ żjieda f’ daqqa fil- PCV, jista ’ jkun hemm żjieda fil- pressjoni tad- demm jew pressjoni għolja ġa eżistenti tista ’ tmur għal agħar.
These increases in blood pressure can be treated with medicinal products.
Dawn iż- żidiet fil- pressjoni tad- demm jistgħu jiġu kkurati b’ prodotti mediċinali.
If blood pressure rises cannot be controlled by drug therapy, a transient interruption of NeoRecormon therapy is recommended.
Jekk iż- żjieda fil - pressjoni tad- demm ma tistax tiġi kkontrollata minn terapija b’ mediċini, interuzzjoni għal ftit taż - żmien tat- terapija b’ NeoRecorman hija rakkomandata.
Particularly at beginning of therapy, regular monitoring of the blood pressure is recommended, including between dialyses.
Speċjalment fil- bidu tat- terapija, hija rakkomandata sorveljanza regolari tal- pressjoni tad- demm, inkluż bejn dijalisi u ieħor.
Hypertensive crisis with encephalopathy-like symptoms may occur and require the immediate attention of a physician and intensive medical care.
Tista ’ sseħħ kriżi ipertensiva b’ sintomi jixbħu lil enċefalopatija li tinħtieġ attenzjoni mmedjata ta ’ tabib u kura medika intensiva.
Particular attention should be paid to sudden stabbing migraine like headaches as a possible warning sign.
Għandha tingħata attenzjoni speċjali lill- uġigħ ta ’ ras li jagħti f’ daqqa, itektek u jixbaħ lill- emikranja, għax jista ’ jkun sinjal possibbli ta ’ twissija.
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.
F’ pazjenti b’ insuffiċjenza kronika tal- kliewi jista ’ jkun hemm żjieda fl- għadd ta ’ plejtlits, li tibqa ’ fil - limiti normali, li tkun tiddependi mid- doża ta ’ NeoRecormon, speċjalment wara li jingħata ġol- vini.
This regresses during the course of continued therapy.
Din tonqos tul il- kors tat- terapija.
It is recommended that the platelet count be monitored regularly during the first 8 weeks of therapy.
Huwa rakkomandat li l- għadd ta ’ plejtlits ikun issorveljat regolarment matul l- ewwel 8 ġimgħat ta ’ terapija.
In patients with chronic renal failure, maintenance haemoglobin concentration should not exceed the upper limit of the target haemoglobin concentration recommended in section 4.2.
F’ pazjenti b’ insuffiċjenza kronika tal- kliewi, l- konċentrazzjoni ta ’ l- emoglobina miżmuma m’ għandhiex taqbeż il- limitu ta ’ fuq tal- konċentrazzjoni mmirata ta ’ l- emoglobina rakkomandata f’ sezzjoni 4. 2.
In clinical trials, an increased risk of death and serious cardiovascular events was observed when erythropoiesis stimulating agents (ESAs) were administered to target a haemoglobin of greater than 12 g/ dl (7.5 mmol/ l).
Fi provi kliniċi, kienet osservata żjieda fir- riskju ta ’ mewt u ta ’ episodji kardjovaskulari serji meta sustanzi li jistimolaw l- eritropoesi (ESAs) ingħataw biex tintlaħaq emoglobina ta ’ aktar minn 12 g/ dl (7. 5 mmol/ l).
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.
6 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.
Effect on tumour growth Epoetins are growth factors that primarily stimulate red blood cell production.
Effett fuq it- tkabbir tat- tumur Epoetins huma fatturi tat- tkabbir li primarjament jistimolaw il- produzzjoni ta ’ ċelluli ħomor tad- demm.
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.
Bħal bil- fatturi tat - tkabbir kollha, hemm il- biża li epoetins jistgħu jistimolaw it- tkabbir ta ’ tumuri. 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.
In controlled clinical studies, use of NeoRecormon and other erythropoiesis-stimulating agents (ESAs) have shown:
Fi studji kliniċi kkontrollati, l- użu ta ’ NeoRecormon u sustanzi oħra li jistimolaw l- eritropoesi wrew:
- shortened time to tumour progression in patients with advanced head and neck cancer receiving
- ħin imqassar sal- progressjoni tat- tumur f’ pazjenti b’ kanċer avvanzat fir- ras u fl- għonq li qed
radiation therapy when administered to target a haemoglobin of greater than 14 g/ dl (8.7 mmol/ l),
jirċievu terapija ta ’ radjazzjoni meta mogħti biex tintlaħaq emoglobina ta ’ aktar minn 14 g/ dl (8. 7 mmol/ l),
- shortened overall survival and increased deaths attributed to disease progression at 4 months in
- sopravivenza globali mqassra u żjieda fl- imwiet attribwiti lill- progressjoni tal- marda wara 4
patients with metastatic breast cancer receiving chemotherapy when administered to target a haemoglobin of 12-14 g/ dl (7.5-8.7 mmol/ l),
xhur f’ pazjenti b’ kanċer metastatiku tas- sider li qed jirċievu kimoterapija meta mogħti biex tintlaħaq emoglobina ta ’ 12- 14 g/ dl (7. 5- 8. 7 mmol/ l),
- increased risk of death when administered to target a haemoglobin of 12 g/ dl (7.5 mmol/ l) in
- żjieda fir- riskju ta ’ mewt meta mogħti biex tintlaħaq emoglobina ta ’ 12 g/ dl (7. 5 mmol/ l)
patients with active malignant disease receiving neither chemotherapy nor radiation therapy.
f’ pazjenti b’ marda malinna attiva li mhux qed jirċievu kimoterapija jew terapija ta ’ radjazzjoni.
ESAs are not indicated for use in this patient population.
ESAs mhumiex indikati għall- użu f’ din il- popolazzjoni ta ’ pazjenti.
In view of the above, in some clinical situations blood transfusion should be the preferred treatment for the management of anaemia in patients with cancer.
Minħabba l- punti msemmijin fuq, f’ xi sitwazzjonijiet kliniċi trasfużjonijiet tad- demm għandhom ikunu l- kura ppreferita għall- immanniġġjar ta ’ anemija f’ pazjenti bil- kanċer.
The decision to administer recombinant erythropoietins should be based on a benefit-risk assessment with the participation of the individual patient, which should take into account the specific clinical context.
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.
Factors that should be considered in this assessment should include the type of tumour and its stage; the degree of anaemia; life- expectancy; the environment in which the patient is being treated; and patient preference (see section 5.1)
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)
There may be an increase in blood pressure which can be treated with drugs.
Jista ’ jkun hemm żjieda fil- pressjoni tad- demm li tista ’ tiġi kkurata b’ mediċini.
It is therefore recommended to monitor blood pressure, in particular in the initial treatment phase in cancer patients.
Għalhekk huwa rrakkomandat li tiġi sorveljata l- pressjoni tad- demm, speċjalment fil- fażi tal- bidu tal- kura f’ pazjenti bil- kanċer.
Platelet counts and haemoglobin level should also be monitored at regular intervals in cancer patients.
L- għadd ta ’ plejtlits u l- livell ta ’ emoglobina ukoll għandhom jiġu sorveljati f’ intervalli regolari f’ pazjenti bil- kanċer.
In patients in an autologous blood predonation programme there may be an increase in platelet count, mostly within the normal range.
Jista ’ jkun hemm żjieda fl- għadd ta ’ plejtlits li fil- biċċa l- kbira tibqa ’ f’ limiti normali, f’ pazjenti li jkunu qegħdin fi programm fejn jingħatalhom id- demm tagħhom stess.
Therefore, it is recommended that the platelet count be determined at least once a week in these patients.
Għalhekk huwa rakkomandat li f’ dawn il- pazjenti l- għadd ta ’ plejtlits jiġi determinat mill- inqas darba fil- ġimgħa.
If there is an increase in platelets of more than 150 x 109/ l or if platelets rise above the normal range, treatment with NeoRecormon should be discontinued.
Jekk ikun hemm żjieda ikbar minn 150 x 109/ l jew jekk il- plejtlits jiżdiedu iktar mill- limitu normali, il- kura b’ NeoRecormon għandha titwaqqaf.
In chronic renal failure patients an increase in heparin dose during haemodialysis is frequently required during the course of therapy with NeoRecormon as a result of the increased packed cell volume.
F’ pazjenti b’ insuffiċjenza kronika tal- kliewi żjieda fid- doża tal- heparin waqt id- dijalisi tad- demm spiss tkun bżonnjuża tul il- kors ta ’ terapija b’ NeoRecormon minħabba li dan iżid il- volum ta ’ ċelluli ppakjati.
Occlusion of the dialysis system is possible if heparinisation is not optimum.
Jekk il- heparinisation ma tkunx l- aħjar, jista ’ jkun hemm okklużjoni tal- magna tad- dijalisi.
Early shunt revision and thrombosis prophylaxis by administration of acetylsalicylic acid, for example, should be considered in chronic renal failure patients at risk of shunt thrombosis.
F’ pazjenti b’ insuffiċjenza kronika tal- kliewi li għandhom riskju ta ’ shunt thrombosis, għandu jiġi ikkunsidrat li ssir reviżjoni ta ’ shunts u lqugħ għat- trombożi billi jingħata acetylsalicylic acid, per eżempju.
Serum potassium and phosphate levels should be monitored regularly during NeoRecormon therapy.
Livelli tal- potassju u l- fosfat fis- serum għandhom ikunu issorveljati regolarment waqt terapija b’ NeoRecormon.
Potassium elevation has been reported in a few uraemic patients receiving NeoRecormon, though causality has not been established.
Elevazzjoni tal- potassju kienet irrappurtata f’ xi pazjenti uremiċi li kienu qed jirċievu NeoRecormon, għalkemm ma kinitx stabbilita il- kawżalita`.
If an elevated or rising potassium level is observed then consideration should be given to ceasing NeoRecormon administration until the level has been corrected.
Jekk ikun osservat livell ogħli ta ’ potassju jew li l- livell ikun qed jiżdied għandu jkun ikkunsidrat li jitwaqqaf NeoRecormon sakemm il- livell ikun irranġat.
For use of NeoRecormon in an autologous predonation programme, the official guidelines on principles of blood donation must be considered, in particular:
7 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];
- special care should be taken with patients below 50 kg weight;
- kura speċjali trid tingħata lil pazjenti li jiżnu inqas minn 50 kg;
12% of the patient's estimated blood
- il- volum meħud f’ darba m’ għandux jaqbeż bejn wieħed u ieħor it- 12% ta ’ dak li hu stmat li hu
volume.
il- volum tad- demm tal- pazjent.
Treatment should be reserved for patients in whom it is considered of particular importance to avoid homologous blood transfusion taking into consideration the risk/ benefit assessment for homologous transfusions.
Il- kura għandha tingħata biss lil pazjenti li għalihom huwa kkunsidrat importanti ħafna li tkun evitata trasfużjoni ta ’ demm omologu, b’ kunsiderazzjoni ta ’ valutazzjoni tar- riskji/ benefiċċji ta ’ trasfużjonijiet omologi.
Misuse by healthy persons may lead to an excessive increase in packed cell volume.
L- użu ħażin minn persuni f’ saħħithom jista ’ jwassal għal żjieda eċċessiva fil- volum ta ’ ċelluli ppakjati.
This may be associated with life-threatening complications of the cardiovascular system.
Dan jista ’ jkun assoċjat ma ’ kumplikazzjonijiet fis- sistema kardjovaskulari li joħolqu periklu ta ’ mewt.
NeoRecormon Multidose contains up to 5.0 mg phenylalanine/ vial as an excipient.
NeoRecormon jista ’ jkun fih sa 5. 0 mg ta ’ phenylalanine/ kunjett bħala sustanza mhux attiva.
Therefore this should be taken into consideration in patients affected with severe forms of phenylketonuria.
Għalhekk, dan għandu jkun ikkunsidrat f’ każ ta ’ pazjenti li jbatu minn forom severi ta ’ phenylketonuria.
NeoRecormon in reconstituted multidose solution contains benzyl alcohol which may cause toxic reactions and anaphylactoid reactions in infants and children up to 3 years old.
NeoRecormon f’ soluzzjoni multidose rikostitwita fih benzyl alcohol li jista ’ jikkawża reazzjonijiet tossiċi u anafilaktojdi fi trabi u tfal b’ età ta ’ 3 snin jew anqas.
7 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 ”.
The clinical results obtained so far do not indicate any interaction of NeoRecormon with other medicinal products.
Ir- riżultati kliniċi miksubin s’ issa ma jurux li hemm interazzjoni ta ’ NeoRecormon ma ’ prodotti mediċinali oħra.
Animal experiments revealed that epoetin beta does not increase the myelotoxicity of cytostatic medicinal products like etoposide, cisplatin, cyclophosphamide, and fluorouracil.
Esperimenti fuq l- annimali wrew li epoetin beta ma jżidx il- mijelotossiċità ta ’ prodotti mediċinali ċitostatiċi bħal etoposide, cisplatin, cyclophosphamide, u fluorouracil.
For epoetin beta no clinical data on exposed pregnancies are available.
Għall- epoetin beta m’ hemmx tagħrif kliniku dwar l- użu waqt it- tqala.
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/ foetal development, parturition or postnatal development (see 5.3).
Studji fuq il- bhejjem ma jurux effetti ħżiena diretti jew indiretti fuq it- tqala, fuq l- iżvilupp ta ’ l- embriju/ fetu, ħlas jew żvilupp wara it - twelid (ara 5. 3).
NeoRecormon has no influence on the ability to drive and use machines.
NeoRecormon m’ għandu l- ebda effett fuq il- ħila biex issuq u tħaddem magni.
Based on results from clinical trials including 1725 patients approximately 8% of patients treated with NeoRecormon are expected to experience adverse reactions.
Skond ir- riżultati miksubin minn provi kliniċi li nkludew 1725 pazjent, madwar 8% tal- pazjenti kkurati b’ NeoRecormon huma mistennija li jkollhom esperjenza ta ’ reazzjonijiet avversi.
- Anaemic patients with chronic renal failure
- Pazjenti anemiċi b’ insuffiċjenza kronika tal- kliewi
The most frequent adverse reaction during treatment with NeoRecormon is an increase in blood pressure or aggravation of existing hypertension, especially in cases of rapid PCV increase (see section 4.4).
Ir- reazzjoni avversa li tinħass l- iktar spiss waqt il- kura b’ NeoRecormon hija żjieda fil- pressjoni tad - demm jew l- aggravazzjoni ta ’ pressjoni għolja eżistenti, speċjalment f’ każijiet fejn hemm żjieda f’ daqqa tal- PCV (ara sezzjoni 4. 4).
Hypertensive crisis with encephalopathy-like symptoms (e. g. headaches and confused state, sensorimotor disorders - such as speech disturbance or impaired gait - up to tonoclonic seizures) may also occur in individual patients with otherwise normal or low blood pressure (see section 4.4).
Tista ’ sseħħ ukoll kriżi ipertensiva b’ sintomi bħal ta ’ enċefalopatija (e. ż. uġigħ ta ’ ras u konfużjoni, problemi ta ’ koordinazzjoni – bħal problemi biex wieħed jitkellem jew diffikultà fil- mixi – sa anki attakki ta ’ epilessija tonokloniċi) f’ pazjenti ndividwali li ssoltu jkollhom pressjoni normali jew baxxa (ara sezzjoni 4. 4).
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.
8 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 most cases, a fall in serum ferritin values simultaneous with a rise in packed cell volume is observed (see section 4.4).
Fil- maġġoranza tal- każijiet, ikun osservat tnaqqis fil- valuri ta ’ ferritin fis- serum flimkien ma ’ żjieda fil- volum ta ’ ċelluli ppakkjati (ara sezzjoni 4. 4).
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 żjiediet temporanji fil- livelli ta ’ potassju u fosfat fis- serum (ara sezzjoni 4. 4).
In isolated cases, neutralising anti erythropoietin antibody-mediated pure red cell aplasia (PRCA) associated with NeoRecormon therapy has been reported.
F’ każijiet iżolati kienet irrappurata aplasja pura taċ- ċelluli ħomor (PRCA) ikkawżata minn antikorpi newtralizzanti kontra l- eritropoetin, f’ assoċjazzjoni ma ’ terapija b’ NeoRecormon.
In case anti-erythropoietin antibody- mediated PRCA is diagnosed, therapy with NeoRecormon must be discontinued and patients should not be switched to another erythropoietic protein (see section 4.4).
F’ każ ta ’ dijanjosi ta ’ PRCA ikkawżata minn antikorpi kontra l- eritropoetin, it- terapija b’ NeoRecormon għandha titwaqqaf u l- pazjenti għandhom jinqalbu għal fuq proteina eritropoetika oħra (ara sezzjoni 4. 4).
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 provi kliniċi, kkunsidrati bħala relatati ma ’ kura b’ NeoRecoromon huma mniżżla fit- tabella taħt.
System Organ Class
Kriżi ipertensiva
Adverse Drug Reaction
Mhux komuni (> 0. 1%, < 1%)
Incidence
Pressjoni għolja
Vascular disorders
Komuni (> 1%, < 10%)
Hypertensive crisis Hypertension
Disturbi fis- sistema nervuża
Uncommon (> 0.1% ,< 1%) Common (> 1% ,< 10%)
Komuni (> 1%, < 10%)
Nervous system disorders Blood and the lymphatic system disorders
Disturbi tad- demm u tas - sistema limfatika
Headache Shunt thrombosis Thrombocytosis
Shunt thrombosis Tromboċitożi
Common (> 1% ,< 10%) Rare (> 0.01% ,< 0.1%) Very rare (< 0.01%)
Rari (> 0. 01%, < 0. 1%) Rari ħafna (< 0. 01%)
Patients with cancer
- Pazjenti bil- kanċer
8 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).
In some patients, a fall in serum iron parameters is observed (see section 4.4).
F’ xi pazjenti, huwa osservat tnaqqis fil- parametri ta ’ ħadid fis- serum (ara sezzjoni 4. 4).
Clinical studies have shown a higher frequency of thromboembolic events in cancer patients treated with NeoRecormon compared to untreated controls or placebo.
Studji kliniċi urew frekwenza ogħla ta ’ avvenimenti trombo- embolitiċi f’ pazjenti bil- kanċer ikkurati b’ NeoRecormon meta mqabbla ma ’ dawk il- kontrolli mhux ikkurati jew ma ’ plaċebo.
In patients treated with NeoRecormon, this incidence is 7% compared to 4% in controls; this is not associated with any increase in thromboembolic mortality compared with controls.
F’ pazjenti kkurati b’ NeoRecormon, din l- inċidenza hija ta ’ 7% meta mqabbla ma ’ 4% fil- kontrolli; din mhix assoċjata ma ’ żjieda fil- mortalità b’ kawża trombo- embolitika meta mqabbla mal- kontrolli.
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.
System Organ Class
Sistema tal- Klassifika tal - Organi
Adverse Drug Reaction
Reazzjoni Avversa tal- Mediċina
Incidence
Inċidenża
Vascular disorders Blood and the lymphatic system disorders
Disturbi vaskulari Disturbi tad- demm u tas - sistema limfatika
Hypertension Thromboembolic event
Pressjoni għolja Avveniment trombo - embolitiku
Common (> 1% ,< 10%) Common (> 1% ,< 10%)
Komuni (> 1%, < 10%) Komuni (> 1%, < 10%)
Common (> 1%, < 10%)
Komuni (> 1%, < 10%)
- Patients in an autologous blood predonation programme
- Pazjenti fi programm ta ’ donazzjoni minn qabel ta ’ demm awtologu
Patients in an autologous blood predonation programme have been reported to show a slightly higher frequency of thromboembolic events.
Pazjenti fi programm ta ’ donazzjoni minn qabel ta ’ demm awtologu kienu rrappurtati li juru frekwenza ta ’ avvenimenti trombo- embolitiċi kemmxejn akbar.
However, a causal relationship with treatment with NeoRecormon could not be established.
Madankollu, ma tistax tiġi stabbilita relazzjoni kawżali ma ’ kura b’ NeoRecormon.
In placebo controlled trials temporary iron deficiency was more pronounced in patients treated with NeoRecormon than in controls (see section 4.4).
Fi provi kliniċi kontrollati bil- plaċebo, defiċjenza temporanja ta ’ ħadid deheret aktar f’ pazjenti kkurati b’ NeoRecormon meta mqabbla mal- gruppi ta ’ kontroll (ara sezzjoni 4. 4).
The incidences of undesirable effects in clinical trials, considered related to treatment with NeoRecoromon are shown in the table below.
9 L- inċidenza ta ’ effetti mhux mixtieqa fi studji kliniċi, kkunsidrati relatati ma ’ kura b’ NeoRecoromon huma mniżżla fit- tabella taħt.
Incidence
Inċidenza
- All indications
- Indikazzjonijiet kollha
Rarely (≥ 1/ 10.000 to ≤ 1/ 1.000), epoetin beta treatment-related skin reactions such as rash, pruritus, urticaria or injection site reactions may occur.
Rarament (≥1/ 10. 000 to ≤1/ 1. 000), reazzjonijiet tal- ġilda relatati ma ’ kura b’ epoetin beta, bħal raxx, ħakk, urtikarja jew reazzjonijiet fis- sit ta ’ l- injezzjoni jistgħu jiġru.
In very rare cases (≤ 1/ 10.000), epoetin beta treatment- related anaphylactoid reactions have been reported.
F’ każijiet rari ħafna (≤1/ 10. 000), kienu rrappurtati reazzjonijiet anafilattiċi relatati ma ’ kura b’ epoetin beta.
However, in controlled clinical studies no increased incidence of hypersensitivity reactions was found.
Madankollu, fi studji kliniċi ikkontrollati ma nstabet l- ebda żjieda fl- inċidenza ta ’ reazzjonijiet ta ’ sensittività eċċessiva.
In very rare cases (≤ 1/ 10.000), particularly when starting treatment, epoetin beta treatment-related flu- like symptoms such as fever, chills, headaches, pain in the limbs, malaise and/ or bone pain have been reported.
F’ każijiet rari ħafna (≤1/ 10. 000), partikolarment fil- bidu tal- kura, kienu rrappurtati sintomi jixbħu lill - influwenza, bħal deni, dehxiet, uġigħ ta ’ ras, uġigħ fid- dirgħajn u fir- riġlejn, telqa u/ jew uġigħ fl - għadam, relatati ma ’ kura b’ epoetin beta.
These reactions were mild or moderate in nature and subsided after a couple of hours or days.
Dawn ir- reazzjonijiet kienu ħfief għal- moderati fin- natura u għaddew wara ftit sigħat jew jiem.
The therapeutic margin of NeoRecormon is very wide.
Il- marġni terapewtiku ta ’ NeoRecormon huwa wiesa ’ ħafna.
Even at very high serum levels no symptoms of poisoning have been observed.
Lanqas f’ livelli għoljin ħafna fis- serum ma dehru sintomi ta ’ avvelenament.
9 Pharmacotherapeutic group: antianaemic, ATC code:
Kategorija farmakoterapewtika: anti- anemiku, Kodiċi ATC:
Epoetin beta is identical in its amino acid and carbohydrate composition to erythropoietin that has been isolated from the urine of anaemic patients.
Epoetin beta huwa identiku fl- amino acids u l- karboidrati tiegħu, għall- eritropoetin li kien iżolat mill - urina ta ’ pazjenti anemiċi.
Erythropoietin is a glycoprotein that stimulates the formation of erythrocytes from its committed progenitors.
Eritropoetin hu glikoproteina li tistimola l- formazzjoni ta ’ ċelluli ħomor tad- demm mill- proġenituri tagħhom.
It acts as a mitosis stimulating factor and differentiation hormone.
Jaħdem bħala fattur li jistimola l- mitożi u bħala ormon ta ’ divrenzjar.
The biological efficacy of epoetin beta has been demonstrated after intravenous and subcutaneous administration in various animal models in vivo (normal and uraemic rats, polycythaemic mice, dogs).
L- effikaċja bijoloġika ta ’ epoetin beta kienet murija wara li ngħatat minn taħt il- ġilda u minn ġol- vini lil diversi annimali in vivo li ntużaw bħala mudell (firien normali u uremiċi, ġrieden poliċitemiċi, klieb).
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 increased 3H-thymidine incorporation in the erythroid nucleated spleen cells has been found in vitro (mouse spleen cell culture) after incubation with epoetin beta.
Instabet żjieda fl- inkorporazzjoni ta ’ 3H thymidine f’ ċelluli eritrojdi b’ nukleu tal- milsa in vitro (kultura ta ’ ċelluli tal- milsa tal- ġrieden) wara inkubazzjoni b’ epoetin beta.
Investigations in cell cultures of human bone marrow cells showed that epoetin beta stimulates erythropoiesis specifically and does not affect leucopoiesis.
Investigazzjonijiet f’ kulturi ta ’ ċelluli tal- mudullun uman urew li epoetin beta jistimula l- formazzjoni ta ’ ċelluli tad- demm ħomor imma ma jaffettwax il- formazzjoni tal- lewkoċiti.
Cytotoxic actions of epoetin beta on bone marrow or on human skin cells were not detected.
Ma kienux osservati azzjonijiet ċitotossiċi ta ’ epoetin beta fuq mudullun jew fuq ċelluli tal- ġilda umana.
After single dose administration of epoetin beta no effects on behaviour or locomotor activity of mice and circulatory or respiratory function of dogs were observed.
Wara amministrazzjoni ta ’ doża waħda ta ’ epoetin beta ma kienux osservati effetti fuq l- imġieba jew fil- mod ta ’ ċaqliq ta ’ ġrieden u fil- funzjonijiet ċirkulatorji u respiratorji tal- klieb.
Survival and tumour progression have been examined in five large controlled studies involving a total of 2833 patients, of which four were double-blind placebo-controlled studies and one was an open- label study.
Is- sopravivenza u l- progressjoni tat- tumur ġew eżaminati f’ ħames studji kbar ikkontrollati li kienu jinvolvu total ta ’ 2833 pazjent, li fosthom erbgħa kienu double- blind u kkontrollati bil- plaċebo u wieħed kien studju open- label.
Two of the studies recruited patients who were being treated with chemotherapy.
Fi tnejn mill- istudji ħadu sehem pazjenti li kienu qed jiġu kkurati
The target haemoglobin concentration in two studies was > 13 g/ dl; in the remaining three studies it was 12- 14 g/ dl.
Il- konċentrazzjoni mmirata ta ’ l- emoglobina fi tnejn mill- istudji kienet > 13 g/ dl; fit - tliet studji li jibqa ’ din kienet 12- 14 g/ dl.
In the four placebo-controlled studies the hazard ratios for overall survival ranged between 1.25 and 2.47 in favour of controls.
Fl- erba ’ studji kkontrollati bil- plaċebo l- proporzjon ta ’ periklu għas- sopravivenza globali varjaw bejn 1. 25 u 2. 47 favur il- kontrolli.
These studies have shown a consistent unexplained statistically significant excess mortality in patients who have anaemia associated with various common cancers who received recombinant human erythropoietin compared to controls.
Dawn l- istudji wrew mortalità eċċessiva statistikament sinifikanti u konsistenti mhux spjegata f’ pazjenti li għandhom anemija assoċjata ma ’ deversi kanċers komuni li rċevew eritropoetin rikombinanti uman meta mqabbel mal- kontrolli.
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).
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).
In patients with baseline haemoglobin ≤ 10 g/ dl (n=899), the hazard ratio point estimate for survival was 0.98 (95% CI 0.68 to 1.40).
F’ pazjenti b’ emoglobina fil- linja bażi ≤ 10 g/ dl (n=899), l- estimu tal- punt tal- proporzjon ta ’ periklu għas- sopravivenza kien 0. 98 (95% CI 0. 68 sa 1. 40).
An increased relative risk for thromboembolic events was observed in the overall population (RR 1.62, 95% CI:
Żjieda fir- riskju relattiv ta ’ episodji tromboembolitiċi kienet osservata fil- popolazzjoni globali (RR 1. 62, 95% CI:
1.13, 2.31).
1. 13, 2. 31).
A systematic review has also been performed involving more than 9000 cancer patients participating in 57 clinical trials.
Twettqet ukoll analiżi sistematika li nvolviet aktar minn 9000 pazjent bil- kanċer li pparteċipaw f’ 57 prova klinika.
0.99, 1.18; 42 trials and 8167 patients).
0. 99, 1. 18; 42 prova u 8167 pazjent).
1.35, 2.06, 35 trials and 6769 patients) was observed in patients treated with recombinant human erythropoietin.
1. 35, 2. 06, 35 prova u 6769 pazjent) kienet osservata f’ pazjenti kkurati b’ eritropoetin rikombinanti umana.
There is therefore consistent evidence to suggest that there may be significant harm to patients with cancer who are treated with recombinant human erythropoietin.
Għalhekk hemm evidenza konsistenti biex tissuġġerixxi li jista ’ jkun hemm ħsara sinifikanti lill- pazjenti b’ kanċer li huma kkurati b’ eritropoetin rikombinanti umana.
The extent to which these outcomes might apply to the administration of recombinant human erythropoietin to patients with cancer, treated with chemotherapy to achieve 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.
In very rare cases, neutralising anti-erythropoietin antibodies with or without pure red cell aplasia (PRCA) occurred during rHuEPO therapy.
F’ każijiet rari ħafna, ffurmaw antikorpi newtralizzanti kontra l- eritropoetin b’ aplasja pura taċ- ċelluli ħomor (PRCA) u anki mingħajrha waqt terapija b’ rHuEPO.
Pharmacokinetic investigations in healthy volunteers and uraemic patients show that the half-life of intravenously administered epoetin beta is between 4 and 12 hours and that the distribution volume corresponds to one to two times the plasma volume.
Investigazzjonijiet farmakokinetiċi f’ voluntiera b’ saħħithom u pazjenti uremiċi juru li l- half- life ta ’ epoetin beta mogħti minn ġol- vini hu ta ’ bejn 4 u 12- il siegħa u li l- volum ta ’ distribuzzjoni jikkorispondi għal darba sa darbtejn il- volum tal- plażma.
Analogous results have been found in animal experiments in uraemic and normal rats.
Riżultati jixxibħu nkisbu minn esperimenti fl- annimali f’ firien normali u uremiċi.
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.
The terminal half-life is higher than after intravenous administration, with an average of 13 - 28 hours.
Il- half- life terminali hija ogħla minn dik wara amministrazzjoni minn ġol- vini, b’ medja ta ’ bejn 13 - 28 siegħa.
Bioavailability of epoetin beta after subcutaneous administration is between 23 and 42% as compared with intravenous administration.
Il- biodisponibiltà ta ’ epoetin beta wara amministrazzjoni minn taħt il- ġilda hija bejn 23 u 42% meta mqabbel ma ’ amministrazzjoni minn ġol- vina.
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, and toxicity to reproduction.
Informazzjoni li mhux klinika, magħmula fuq studji konvenzjonali ta ’ sigurtà farmakoloġika, effett tossiku minn dożi ripetuti, effett tossiku fuq il- ġeni, effett tossiku fuq is- sistema riproduttiva, ma turi l - ebda periklu speċjali għall- bnedmin.
A carcinogenicity study with homologous erythropoietin in mice did not reveal any signs of proliferative or tumourigenic potential.
Studju dwar il- karċenoġeniċita` b’ eritropoetin omologu fil- ġrieden ma żvelax sinjali ta ’ potenzjal proliferattiv jew tumuroġeniku.
Lyophilisate:
Lajofiliżat:
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, Glycine, L- Leucine, L- Isoleucine, L- Threonine, L- Glutamic acid, L- Phenylalanine.
Benzyl alcohol, Benzalkonium chloride, Water for injections.
Benzyl alcohol, Benzalkonium chloride, Ilma għall- injezzjonijiet.
(content of accompanying solvent ampoule).
Dan il- prodott mediċinali m’ għandux jitħallat ma ’ prodotti mediċinali oħrajn ħlief dawk imsemmija f’ sezzjoni 6. 6 (kontenut ta ’ l- ampulla bis- solvent li tiġi miegħu).
11 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
Keep the vial in the outer carton, in order to protect from light.
Żomm il- kunjett fil- kartuna ta ’ barra, sabiex tilqa ’ mid- dawl.
For the purpose of ambulatory use, the patient may remove the unreconstituted product from the refrigerator and store it at room temperature (not above 25°C) for one single period of up to 5 days.
Għall- skop ta ’ użu ambulatorju, il- pazjent jista ’ jneħħi l- prodott mill- friġġ u jżommu f’ temperatura ambjentali (mhux aktar minn 25 °C), għall- perjodu wieħed ta ’ mhux aktar minn ħamest ijiem.
Leaving the reconstituted solution outside the refrigerator should be limited to the time necessary for preparing the injections.
Iż - żamma ta ’ soluzzjoni rikostitwita barra mill- friġġ għandha tiġi limitata għall- ħin neċessarju biex jiġu ippreparati l- injezzjonijiet.
For storage conditions of the reconstituted medicinal product see section 6.3.
Għall- kundizzjonijiet ta ’ ħażna tal- prodott mediċinali rikostitwit ara sezzjoni 6. 3.
Lyophilisate (50,000 IU) for solution for injection in a vial (type I glass) with a stopper (teflonised rubber) and 10 ml of solvent in an ampoule (type I glass), with one reconstitution and withdrawal device with one needle (21G2), and one disposable syringe (polypropylene and polyethylene) (10 ml).
Lajofiliżat (50, 000 IU) għal soluzzjoni għall- injezzjoni f’ kunjett (ħġieġ tip I) b’ tapp (lasktu teflonizzat) u 10 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) (10 ml).
NeoRecormon Multidose is supplied as a lyophilisate for solution for injection in vials.
NeoRecormon Multidose huwa disponibbli bħala lajofiliżat għal soluzzjoni għall- injezzjoni f ’ kunjetti.
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.
Dan jinħall bil- kontenut ta ’ l- ampulla bis- solvent li tiġi magħha permezz ta ’ apparat
Only solutions which are clear or slightly opalescent, colourless and practically free of visible particles may be injected.
Jista ’ jkunu injettati biss dawk is - soluzzjonijiet li jkun ċari jew kemm xejn ikanġu, bla kulur u li prattikament mingħajr frak li jidhru.
Do not use glass materials for injection, use only plastic materials.
Tużax materjali tal- ħġieġ għall- injezzjoni, uża biss materjali tal- plastik.
This is a multidose preparation from which different single doses can be withdrawn over a period of 1 month after dissolution.
Din hija preparazzjoni multidose li minna jistgħu jinġibdu għadd ta ’ dożi waħdanin għal perijodu ta ’ xahar wara li d- dissoluzzjoni.
To avoid the risk of contamination of the contents always observe aseptic techniques (i. e. use disposable sterile syringes and needles to administer each dose) and strictly follow the handling instructions below.
Dejjem osserva teknika assettika (jiġifieri, uża siringi u labar sterili u li jintremew wara l- użu għall- kull doża li tingħata) sabiex tevita r- riskju ta ’ kontaminazzjoni tal- kontenut, u segwi sew l- istruzzjonijiet ta ’ kif jintuża mogħtijin hawn taħt.
Before withdrawing each dose disinfect the rubber seal of the withdrawal device with alcohol to prevent contamination of the contents by repeated needle insertions.
Qabel ma tinġibed kull doża, iddiżinfetta s- siġill tal- lastiku tal- apparat għal ġbid bl- alkoħol biex tipprevjeni l- kontaminazzjoni tal - kontenut minħabba t- titqib ripetut bil- labar.
Preparation of NeoRecormon Multidose solution (1) Take the vial with the freeze-dried substance out of the package.
Il- preparazzjoni ta ’ soluzzjoni NeoRecormon Multidose (1) Oħroġ mill- pakkett il- kunjett li fih is- sustanza mnixxfa bil- friża.
Write the date of reconstitution and expiry on the label (expiry is 1 month after reconstitution).
Ikteb id- data tar- rikostituzzjoni u d’ data meta tiskadi fuq it- tikketta (tiskadi wara xahar mir- rikostituzzjoni).
(2) Remove the plastic cap from the vial.
(2) Neħħi l- għatu tal- plastik tal- kunjett.
(3) Disinfect the rubber seal with alcohol.
(3) Iddiżinfetta s- sigill tal- lasktu bl- alkoħol.
(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.
(5) Attach the device to the vial until the snap lock clicks home.
(5) Waħħal l- apparat mal- kunjett sakemm is- snap lock ifaqqa ’.
(6) Put the green needle on the syringe contained in the package and remove the needle cover.
(6) Poġġi l- labra l- ħadra fuq is- siringa li tinsab fil- pakkett u neħħi l- għatu tal- labra.
(7) Hold the OPC (One-Point-Cut) ampoule with the blue point upwards.
(7) Żomm l- ampulla OPC (One- Point- Cut) bil- marka l- blu tħares ‘ il fuq.
Shake or tap the ampoule to get any fluid in the stem into the body of the ampoule.
Ħawwad jew tektek l - ampulla sabiex il- likwidu fl- għonq jgħaddi għall- parti ewlenija ta ’ l- ampulla.
Take hold of the stem and snap off away from you.
Żomm l- għonq u aqsmu ‘ l bogħod minnek.
Withdraw all the solvent into the syringe.
Iġbed is- solvent kollu ġos- siringa.
Disinfect the rubber seal of the device with alcohol.
Iddiżinfetta s- siġill tal- lasktu ta ’ l- apparat bl - alkoħol.
(8) Penetrate the seal with the needle to a depth of about 1 cm and slowly inject the solvent into the vial.
(8) Ippenetra s- siġill bil- labra sa 1 cm fond u bil- mod injetta s- solvent ġol- kunjett.
Then disconnect the syringe (with needle) from the device.
Imbagħad aqla ’ s - siringa (bil- labra) minn ma ’ l- apparat.
(9) Swirl the vial gently until the lyophilisate has dissolved.
(9) Dawwar il- kunjett fuqu nnifsu bil- mod sakemm jinħall il- lajofiliżat.
Check that the solution is clear, colourless and practically free from particles.
Ara li s- soluzzjoni tkun ċara, bla kulur, u prattikament mingħajr l- ebda frak.
Put the protective cap on the top of the device.
Poġġi l- għatu ta ’ protezzjoni fuq il- part ta ’ fuq ta ’ l- apparat.
(10) Before and after reconstitution NeoRecormon Multidose must be stored at +2° to +8°C (refrigerator).
(10) Kemm qabel u kemm wara r- rikostituzzjoni, NeoRecormon Multidose għandu jinżamm taħt temperatura ta ’ bejn +2 ˚C u +8 ˚C (fil- friġġ).
12 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.
(2) Place a 26G needle onto an appropriate single-use syringe (max.1 ml).
(2) Qiegħed labra 26G fuq siringa xierqa li tintuża darba biss (massimu 1 ml).
(3) Remove the needle cover and insert the needle through the rubber seal of the device.
(3) Neħħi l- għatu tal- labra u daħħalha minn ġos- siġill tal- lasktu ta ’ l- apparat.
Withdraw NeoRecormon solution into the syringe, expel air from the syringe into the vial and adjust the amount of NeoRecormon solution in the syringe to the dose prescribed.
Iġbed is- soluzzjoni ta ’ NeoRecormon ġos- siringa, neħħi l- arja mis- siringa għal gol- kunjett u rranġa l- ammont ta 'soluzzjoni ta ’ NeoRecormon fis- siringa skond id- doża preskritta.
Then disconnect the syringe (with needle) from the device.
Imbagħad neħħi s- siringa (bil- labra) minn ma ’ l- apparat.
(4) Replace the needle by a new one (the new needle should have the size which you normally use for injections).
(4) Ibdel il- labra ma ’ waħda ġdida (il- labra l- ġdida trid tkun tad- daqs li normalment tintuża għall - injezzjonijiet).
(5) Remove the needle cover and carefully expel air from the needle by holding the syringe vertically and gently pressing the plunger upwards until a bead of liquid appears at the needle tip.
(5) Neħħi l- għatu tal- labra u b’ attenzjoni armi l- arja minn ġol- labra billi żomm is- siringa wieqfa u bil - mod agħfas il- planġer ‘ il fuq sakemm tidher qatra tal- likwidu mat- tarf tal- labra.
For subcutaneous injection, clean the skin at the site of injection using an alcohol wipe.
Għal injezzjoni li tingħata taħt il- ġilda, naddaf il- ġilda fejn se ssir l- injezzjoni b’ imselħa ta ’ l- alkoħol.
Form a skin fold by pinching the skin between the thumb and the forefinger.
Ifforma tinjafil- ġilda billi toqros il- ġilda bejn is- saba ’ l- kbir u l- werrej.
Hold the syringe near to the needle and insert the needle into the skin 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 NeoRecormon solution.
Injetta s- soluzzjoni ta ’ NeoRecormon.
Withdraw the needle quickly and apply pressure over the injection site with a dry, sterile pad.
Iġbed il- labra malajr u agħfas fejn ingħatat l- injezzjoni b’ biċċa xotta u sterili.
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
Date of the first authorisation:
Data ta ’ l- ewwel awtorizzazzjoni:
16 July 1997 Date of the last renewal:
16 ta ’ Lulju 1997 Data ta ’ l- aħħar tiġdid:
16 July 2007
16 ta ’ Lulju 2007
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/.
Informazzjoni dettaljata dwar dan il- prodott tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il - Mediċini (EMEA) http: // www. emea. europa. eu /
NeoRecormon Multidose 100,000 IU Lyophilisate and solvent for solution for injection (20,000 IU/ ml)
NeoRecormon Multidose 100, 000 IU Lajofiliżat u solvent għal soluzzjoni għall- injezzjoni (20, 000 IU/ ml)
One vial contains 100,000 international units (IU) corresponding to 830 micrograms epoetin beta* (recombinant human erythropoietin).
Kunjett wieħed fih 100, 000 unita internazzjonali (IU) li jikkorrispondu għal 830 mikrogrammi epoetin beta * (eritropoetin rikombinanti uman).
One ampoule contains 5 ml solvent (water for injections with benzyl alcohol and benzalkonium chloride as preservatives).
Ampulla waħda fiha 5 ml solvent (ilma għall- injezzjonijiet bl- alkoħol benżiliku u klorur tal - benżalkonju bħala preservattivi).
One ml of reconstituted solution contains 20,000 IU epoetin beta.
Kull ml ta ’ soluzzjoni rikostitwita fiha 20, 000 IU epoetin beta.
Phenylalanine (up to 5.0 mg/ vial) Sodium (less than 1 mmol per dose) Benzyl alcohol (up to 20 mg per multidose solvent ampoule)
Phenylalanine (sa 5. 0 mg/ kunjett) Sodju (inqas minn 1 mmol kull doża) Benzyl alcohol (sa 20 mg kull ampulla multidose bis- solvent)
To avoid the risk of cross-infection always follow aseptic techniques and use disposable sterile syringes and needles for each administration.
Sabiex jiġi evitat it- tixrid ta ’ infezzjonijiet fost il- pazjenti, dejjem żomm mat- teknika assettika u uża siringi u labar sterili li jistgħu jintremu għal kull
The reconstituted product is a colourless, clear to slightly opalescent solution.
Il- prodott rikostitwit huwa soluzzjoni bla kulur, ċara għal kemmxejn tkanġi.