qanastek/EMEA-V3 huggingface dataset:
Only hold the blue plastic adapter when removing.
Żomm l- adattatur il- blu tal- plastik meta tkun qed tneħħih biss.
Keep the syringe in a horizontal position and the vial below the syringe.
Żomm is- siringa f’ pożizzjoni orizzontali u l- kunjett taħt is- siringa.
Removing the vial and adapter from the syringe ensures that the solution will flow out from the needle when injected.
115 Li tneħħi l- kunjett u l- adattatur minn mas- siringa jiżgura li s - soluzzjoni tgħaddi mil- labra meta tiġi injettata.
111 17 - Dispose of the vial and any unused portion of the solution in the disposal unit
17 – Armi l- kunjett u kwalunkwe porzjon mhux użat tas- soluzzjoni fir- reċipjent tar- rimi
18 - You are now ready to inject.
18 - Issa inti lest/ a biex tinjetta.
If, for some reason, you are not able to inject the Betaferon immediately, you can keep the reconstituted solution in the syringe in a refrigerator for up to 3 hours before using.
Jekk, għal xi raġuni, ma tkunx tista ’ tinjetta Betaferon minnufih, tista ’ żżomm s- soluzzjoni rikostitwita fis- siringa fi friġġ sa 3 sigħat qabel ma tużaha.
If more than 3 hours pass, discard the reconstituted Betaferon solution and prepare a new injection.
Jekk jgħaddu iktar minn 3 sigħat, armi s- soluzzjoni rikostitwita ta ’ Betaferon u ipprepara injezzjoni ġdida.
When you use the solution, warm it up in your hands before injecting to avoid pain.
Meta tuża s- soluzzjoni, saħħanha f’ idejk qabel tinjettaha biex tevita l- uġigħ.
2 - Use an alcohol wipe to clean the skin at the injection site.
2 - Uża mselħa bl- alkoħol biex tnaddaf il- ġilda fil- lok ta ’ l- injezzjoni.
Throw the wipe away.
Armi l- imselħa.
3 - Remove the cap from the needle by pulling not twisting it.
3 - Neħħi l- għatu mil- labra billi tiġbdu u mhux billi ddawru.
Betaferon can also be administered with an auto-injector.
Betaferon jista ’ jingħata wkoll b’ awto- injettatur.
112 F) Quick review of the process
116 F) Reviżjoni malajr tal- proċess
- - - - - -
- Qabbad is- siringa ma ’ l- adattatur tal- kunjett
Take out the required content for one injection Attach vial adapter to the vial Connect the syringe to the vial adapter Push syringe plunger to transfer all the solvent into the vial Turn the syringe assembly over and draw up the prescribed amount of the solution Remove vial from syringe - you are now ready to inject
- Imbotta l- planġer tas- siringa sabiex tittrasferixxi s- solvent kollu fil- kunjett
113 PART II:
117 PARTI II:
By following this schedule, you will come back to your first area (e.g. the right side of the abdomen) after 8 injections (16 days).
Billi ssegwi din l- iskeda, għandek tiġi lura fl- ewwel lok (e. ż. in- naħa tal- lemin taż- żaqq) wara 8 injezzjonijiet (16- il jum).
Middle right section of each area
118 SKEDA TA ’ ROTAZZJONI:
114 ROTATION SCHEDULE:
10- 15 ċm mill - ispalla
AREA 8
ŻONA 7 ŻONA 8
AREA 7
Il- warrani fuq in - Il- warrani fuq in - Naħa tal- Lemin Naħa tax- Xellug
115 PART III:
119 PARTI III:
Instructions for keeping track of your injection sites and dates
Istruzzjonijiet biex iżżomm rekord tal- lokijiet ta ’ l- injezzjoni u tad- dati.
- Select an injection site for your first injection.
- Agħżel lok għall- injezzjoni għall- ewwel injezzjoni tiegħek.
- Clean the injection site with an alcohol wipe and let it air-dry.
- Naddaf il- lok ta ’ l- injezzjoni b’ imselħa ta ’ l- alkoħol u ħalliha tinxef.
- After your injection, fill in the used injection site and date on the table in your injection record
- Wara l- injezzjoni, imla s- sezzjoni li turi l- lok ta ’ l- injezzjoni li ntużat u d- data fit- tabella fir- rekord
(see the example: ‘Keeping track of your injection sites and dates’).
Kif iżżomm rekord tal- lokijiet ta ’ l- injezzjoni u tad- dati
116 EXAMPLE OF A MEDICATION RECORD:
10- 15 ċm mill - Driegħ tax- xellug
117 Separate Annex:
121 Anness Separat:
INTRODUCTORY LEAFLET FOR TITRATION PACK
FULJETT TA ’ INTRODUZZJONI GĦALL- PAKKETT TA ’ TITRAZZJONI
You will best tolerate Betaferon in the beginning if you start with a low dose and gradually increase to the full standard dose (see first part of the package leaflet, section 3. ‘How to use Betaferon’).
Fil- bidu se tittollera Betaferon aħjar jekk tibda b’ doża baxxa u iżżid għad- doża standàrd sħiħa b’ mod gradwali (ara l- ewwel parti tal - fuljett ta ’ tagħrif, sezzjoni 3. ‘ Kit tuża Betaferon ’).
You will find in the Betaferon titration pack 4 differently coloured and numbered triple packs, each containing: • 3 Betaferon vials (with powder for solution for injection) • 3 pre-filled syringes with solvent for the Betaferon powder (sodium chloride solution 5.4 mg/ml (0.54%)) • 3 vial adapters with a pre-attached needle • 6 alcohol wipes for skin and vial cleaning Each triple pack contains the syringes you will require for preparing each dose.
Fil- pakkett ta ’ titrazzjoni ta ’ Betaferon se ssib 4 pakketti tripli ta ’ kulur u b’ numru differenti li kull wieħed fih: • 3 kunjetti ta ’ Betaferon (bi trab għal soluzzjoni għall- injezzjoni) • 3 siringi mimlija għall- lest b’ solvent għat- trad ta ’ Betaferon (soluzzjoni ta ’ sodium chloride ta ’ 5. 4 mg/ ml (0. 54%)) • 3 adatturi tal- kunjett b’ labra mwaħħla minn qabel • 6 imsielaħ ta ’ l- alkoħol biex tnaddaf il- ġilda u l- kunjett
The syringes have special markings for this dose.
Is- siringi għandhom marki speċjali għal din id- doża.
Please follow in detail the instructions for use below.
Jekk jogħġbok segwi fid- dettal l- istruzzjonijiet għall- użu taħt.
Start by using the yellow triple pack which is clearly marked with a “1” on the top right hand side of the box.
Ibda ’ billi tuża l- pakkett triplu ta ’ lewn l- isfar li huwa mmarkat b’ mod ċar b ’ “ 1 ” fuq in- naħa ta ’ fuq tal- lemin tal- kaxxa.
This first triple pack should be used for treatment days 1, 3 and 5.
Dan l- ewwel pakkett triplu għandu jintuża għal ġranet ta ’ kura 1, 3 u 5.
It contains specially marked syringes with 0.25 ml marking.
Huwa fih siringi mmarkati b’ mod speċjali b ’ marka f’ 0. 25 ml.
This will help you to inject the required dose only.
Dan jgħinek tinjetta d- doża meħtieġa biss.
After finishing with the yellow pack, start using the red triple pack which is clearly marked with a "2" on the top right hand side of the box.
Wara li tispiċċa l- pakkett l- isfar, ibda ’ uża l- pakkett triplu ta ’ lewn aħmar li huwa mmarkat b’ mod ċar b ’ “ 2 ” fuq in- naħa ta ’ fuq tal- lemin tal- kaxxa.
This second triple pack should be used for treatment days 7, 9 and 11.
Dan it- tieni pakkett triplu għandu jintuża għal ġranet ta ’ kura 7, 9 u 11.
It contains specially marked syringes with 0.50 ml marking.
Huwa fih siringi mmarkati b’ mod speċjali b ’ marka f’ 0. 50 ml.
After finishing with the red pack, start using the green triple pack which is clearly marked with a "3" on the top right hand side of the box This third triple pack should be used for treatment days 13, 15 and 17.
Dan it- tielet pakkett triplu għandu jintuża għal ġranet ta ’ kura 13, 15 u 17.
It contains specially marked syringes with 0.75 ml marking.
Huwa fih siringi mmarkati b’ mod speċjali b ’ marka f’ 0. 75 ml.
Finally, after finishing with the green pack, start using the blue triple pack which is clearly marked with a "4" on the top right hand side of the box.
Fl- aħħar, wara li tispiċċa l- pakkett l- aħdar, ibda ’ uża l- pakkett triplu ta ’ lewn blu li huwa mmarkat b’ mod ċar b ’ “ 4 ” fuq in- naħa ta ’ fuq tal- lemin tal- kaxxa.
This last triple pack should be used for treatment days 19, 21 and 23.
Dan l- aħħar pakkett triplu għandu jintuża għal ġranet ta ’ kura 19, 21 u 23.
It contains specially marked syringes with 0.25, 0.5, 0.75 and 1.0 ml markings.
Huwa fih siringi mmarkati b’ mod speċjali b ’ marki f’ 0. 25, 0. 5, 0. 75 u 1. 0 ml.
Use the complete amount of solvent for reconstitution of the Betaferon powder, and inject the full dose 1.0 ml.
Uża l- ammont komplet ta ’ solvent għar- rikostituzzjoni tat- trab ta ’ Betaferon, u injetta d- doża kolla ta ’ 1. 0 ml.
For a description of how to prepare and use the Betaferon powder, please refer to section 3. ‘How to use Betaferon’in the first part of the package leaflet and to the Annex'Self-injection procedure' in the second part of the package leaflet.
Għal deskrizzjoni dwar kif tipprepara u tuża t- trab ta ’ Betaferon, jekk jogħġbok irreferi għal sezzjoni 3. ‘ Kif tuża Betaferon ’ fl- ewwel parti tal- fuljett ta ’ tagħrif u għall- Anness ‘ Proċedura ta ’ kif tinjetta lilek innifsek ’ fit- tieni parti tal- fuljett ta ’ tagħrif.
CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FIR- RIGWARD TA ’ L- UŻU MINGĦAJR PERIKLU U EFFETTIV TAL- PRODOTT MEDIĊINALI LI JRIDU JIĠU IMPLIMENTATI MILL- ISTATI MEMBRI
1 CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
1 KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FIR- RIGWARD TA ’ L- UŻU MINGĦAJR PERIKLU U EFFETTIV TAL- PRODOTT MEDIĊINALI LI JRIDU JIĠU IMPLIMENTATI MILL- ISTATI MEMBRI
The Member States shall ensure that prior to launch the MAH provides health care professionals in dialysis centres and retail pharmacies with:
l- Istati Membri għandhom jiżguraw li qabel il- prodott jitpoġġa fuq is- suq, l- MAH għandu jipprovdi lill- professjonisti fiċ- ċentri tad- dijalisi u spiżeriji kummerċjali dawn li ġejjin:
• Educational leaflet • Summary of product characteristics (SPC) and Package Leaflet and Labelling • Cool boxes for patients clearly labelled with a visual aid indicating correct use of product.
• Fuljett edukattiv • Sommarju tal- Karatteristiċi tal- Prodott (SPC) u Fuljett ta ’ Tagħrif u Tikketta • Kaxxi għal pazjenti, li jkunu mmarkati b’ mod ċar b’ għajnuna viżwali li tindika b’ mod ċar l- użu korrett tal- prodott.
The educational leaflet shall contain the following key elements: • That the use of epoetin alfa products can cause immunogenicity which in rare cases may lead to Pure Red Cell Aplasia (PRCA) • That with other epoetin products, the risk of immunogenicity in Chronic Kidney Disease (CKD) is increased with the subcutaneous (sc) route. • There is insufficient data on Binocrit to know the size of any increased immunogenicity risk with sc use • Therefore, the sc route is not recommended for patients with CKD • The loss of efficacy or other symptoms of the development of immunogenicity should be investigated • Any suspected case of Pure Red Cell Aplasia or development of immunogenicity should be reported to the MAH
Il- fuljett edukattiv għandu jkun fih l- elementi importanti li ġejjin: • Li l- użu tal- prodotti li fihom epoetin alfa jista ’ jikkawża immunoġeniċità li f’ każijiet rari tista ’ twassal għal Aplasija taċ- Ċelluli l- Ħomor Pura (PRCA) • Li ma ’ prodotti oħrajn ta ’ epoetin, ir- riskju ta ’ immunoġeniċità f’ Mard Kroniku tal- Kliewi (CKD) jiżdied meta jingħata minn taħt il- ġilda (sc). • Hemm informazzjoni insuffiċjenti fuq Binocrit biex ikun magħruf il- kobor ta ’ xi żieda fir- riskju ta ’ immunoġeniċità bl- użu minn taħt il- ġilda • Għalhekk, ir- rotta ta ’ taħt il- ġilda mhix rakkomandata għal pazjenti li għandhom CKD • It- telf ta ’ effikaċja jew sintomi oħrajn ta ’ l- iżvilupp ta ’ immunoġeniċità għandhom ikunu investigati • Kwalunkwe każ issuspettat ta ’ Aplasija taċ- Ċelluli l- Ħomor Pura jew l- iżvilupp ta ’ immunoġeniċità għandhom ikunu rrappurtati lill- MAH
EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR)
RAPPORT TA ’ VALUTAZZJONI PUBBLIKA EWROPEW (EPAR)
EPAR summary for the public
Sommarju tal- EPAR għall- pubbliku
This document is a summary of the European Public Assessment Report (EPAR).
Dan id- dokument huwa sommarju tar- Rapport ta ’ Valutazzjoni Pubblika Ewropew (EPAR).
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.
Huwa jispjega kif il- Kumitat għal Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) ivvaluta l- istudji mwettqa, biex jissodisfa ir- rakkomandazzjonijiet tagħhom dwar kif tintuża l- mediċina.
If you need more information about your medical condition or your treatment, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Jekk teħtieġ iktar tagħrif dwar il- kundizzjoni medika jew it- trattament tiegħek, aqra l- Fuljett ta 'Tagħrif (ukoll parti mill- EPAR) jew kellem lit- tabib jew spiżjar tiegħek.
If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).
Jekk trid aktar informazzjoni abbażi tar- rakkomandazzjonijiet ta ’ CHMP, aqra d- Diskussjoni Xjentifika (ukoll parti mill- EPAR).
What is Binocrit?
X' inhu Binocrit?
Binocrit is a solution for injection.
Binocrit huwa soluzzjoni għal injezzjoni.
It is available in pre-filled syringes containing between 1,000 and 10,000 international units (IU) of the active substance, epoetin alfa.
Jiġi f' siringi mimlijin għal- lest li fihom bejn 1, 000 u 10, 000 unità internazzjonali (IU) tas- sustanza attiva, epoetin alfa.
Binocrit is a ‘ biosimilar’ medicine.
Binocrit huwa mediċina ‘ bijosimili ’.
This means that Binocrit is similar to a biological medicine that is already authorised in the European Union (EU) and contains the same active substance (also known as the ‘ reference medicine’).
Dan ifisser li Binocrit huwa simili għal mediċina bijoloġika li diġà hija awtorizzata fl- Unjoni Ewropea (UE) u fih l- istess sustanza attiva (magħrufa ukoll bħala ‘ mediċina ta 'referenza ’).
The reference medicine for Binocrit is Eprex/ Erypo.
Il- mediċina ta 'referenza għal Binocrit hija Eprex/ Erypo.
For more information on biosimilar medicines, see the question-and-answer document here.
Għal aktar informazzjoni dwar mediċini biosimili, ara d- dokument b' mistoqsijiet u tweġibiet hawnhekk.
What is Binocrit used for?
Għal x' hiex jintuża Binocrit?
Binocrit is used in the following situations: • to treat anaemia (low red blood cell counts) that is causing symptoms in patients with ‘ chronic renal failure’ (long-term, progressive decrease in the ability of the kidneys to work properly) or other kidney problems; • to treat anaemia in adults receiving chemotherapy for certain types of cancer and to reduce the need for blood transfusions; • to increase the amount of blood that can be taken in adult patients with moderate anaemia who are going to have an operation and donate their own blood before surgery (autologous blood transfusion); • to reduce the need for blood transfusions in adults with mild anaemia who are about to undergo major orthopaedic (bone) surgery, such as hip surgery.
Binocrit jintuża biex jistimula l- produzzjoni ta 'ċelloli tad- demm ħomor fis- sitwazzjonijiet li ġejjin: • biex jitratta anemija (għadd baxx ta' ċelloli tad- demm ħomor) li tikkawwża sintomi f’ pazjenti b’ indeboliment kroniku tal- kliewi (tnaqqis progressiv, fit- tul fl- abbiltà li l- kliewi jaħdmu tajjeb) jew problemi oħra tal- kliewi, • biex jittratta anemija f' adulti li qed jirċievu kimoterapija għal ċerti tipi ta 'kanċer u biex inaqqas il - ħtieġa ta' trasfużjonijiet tad- demm, • biex jiżdied l- ammont ta ’ demm li jista ’ jiġi meud minn pazjenti adulti b’ anemija moderata li jkun ser ikollhom operazzjoni u jagħtu demmhom stess qabel l- operazzjoni (trasfużjoni tad- demm awtologa), • biex inaqqas il- ħtieġa ta 'trasfużjonijiet tad- demm fl- adulti b' anemija ħafifa li jkunu se jgħamlu kirurġija ortopedika (tal- għadam) ta ’ natura serja, bħal kirurġija fuq il- ġenbejn.
It is used in patients with normal blood iron levels who could experience complications if they were to receive a blood transfusion, if they do not have the opportunity to donate their own blood before surgery and are expected to lose 900 to 1,800 ml of blood.
Jintuża f' pazjenti b' livelli normali ta 'ħadid fid- demm li jistgħu jesperjenzaw kumplikazzjonijiet li kieku kellhom jirċievu trasfużjoni tad- demm, jekk ma jkollhomx l- opportunità li jagħtu d- demm tagħhom stess qabel il- kirurġija u huma mistennija li jitilfu 900 sa 1, 800 ml ta' demm.
The medicine can only be obtained with a prescription.
Il- mediċina tista 'tinkiseb biss b' riċetta ta' tabib.
How is Binocrit used?
Kif jintuża Binocrit?
Treatment with Binocrit must be started under the supervision of a doctor who has experience in the management of patients with the conditions that the medicine is used for.
It- trattament b' Binocrit għandu jinbeda taħt is- sorveljanza ta 'tabib li għandu esperjenza fil- ġestjoni ta' pazjenti bil- kundizzjonijiet li l- mediċina hija wżata għalihom.
Patients receiving chemotherapy or about to undergo orthopaedic surgery must be injected under the skin.
Għal pazjenti bi problemi tal- kliewi u pazjenti li ser jagħtu demmhom stess, Binocrit għandu jiġi injettat ġol- vini (intravenously), filwaqt li l - pazjenti li jkunu qegħdin jirċievu kimoterapija jew li jkunu waslu biex jagħmlu kirurġija għandhom jirċievuh taħt il- ġilda (subcutaneously).
Binocrit can be injected under the skin by the patient or their carer if
Binocrit jista ’ jiġi injettat taħt il- ġilda mill- pazjent jew minn min jieħu ħsiebu jekk dawn ikunu imħarrġa kif suppost.
7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Id- doża, il- frekwenza tal- injezzjoni u għal 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel.
Reproduction is authorised provided the source is acknowledged. they have been trained appropriately.
Reproduction is authorised provided the source is acknowledged. kemm żmien tintuża jiddependu fuq l- għala Binocrit qiegħed jintuża, u huma aġġustati skond ir - reazzjoni tal- pazjent.
The dose, the frequency of injection and how long it is used for depend on why Binocrit is being used, and are adjusted according to the patient’ s response.
Id- doża, il- frekwenza ta ’ injezzjoni u għal kemm tintuża jiddependu fuq għaliex Binocrit ikun qed jintuża u huma aġġustati skond ir- reazzjoni tal- pazjent.
For patients with chronic renal failure or receiving chemotherapy, haemoglobin levels should remain within the recommended range (between 10 and 12 grams per decilitre in adults and between 9.5 and 11 g/ dl in children).
Għal pazjenti b’ mard kroniku tal- kliewi jew li jirċievu kimoterapija, il- livelli tal- emoglobina għandhom jibqgħu fl- iskema rakkomandata (bejn 10 u12 – il gramma għal kull dekalitru f’ adulti u bejn 9. 5 u 11 g/ dl fit- tfal).
Haemoglobin is the protein in red blood cells that carries oxygen around the body.
L- L - emoglobina hija l- proteina fiċ- ċelloli ħomor tad- demm li jġorru l- ossiġenu mal- ġisem.
For these patients, the lowest dose that provides adequate control of symptoms should be used.
Għal dawk il - pazjenti, għandha tintuża l- aktar doża baxxa li tipprovdi kontroll xieraq tas- sintomi.
The iron levels of all patients should be checked before treatment to make sure that they are not too low, and iron supplements should be used throughout treatment.
Il- livelli tal- ħadid tal- pazjenti kollha għandhom jiġu kkontrollati qabel it- trattament sabiex ikun żgurat li ma jkunux baxxi ħafna, u għandhom jintużaw supplimenti tal- ħadid tul it- trattament kollu.
For full details, see the Package Leaflet.
Għal aktar tagħrif, ara l- Fuljett ta 'Tagħrif.
How does Binocrit work?
Kif jaħdem Binocrit?
A hormone called erythropoietin stimulates the production of red blood cells from the bone marrow.
Ormon imsejjaħ erythropoietin jistimula l- produzzjoni ta 'ċelloli tad- demm ħomor mill- mudullun.
Erythropoietin is produced by the kidneys.
Erythropoietin huwa prodott mill- kliewi.
In patients receiving chemotherapy or with kidney problems, anaemia can be caused by a lack of erythropoietin, or by the body not responding enough to the erythropoietin it has naturally.
F' pazjenti li jkunu qegħdin jirċievu kimoterapija jew f' pazjenti bi problemi fil- kliewi, l- anemija tista 'tkun ikkawżata minn nuqqas ta' erythropoietin, jew billi l- ġisem ma jirrispondix tajjeb biżżejjed għal erythropoietin li huwa għandu b' mod naturali.
In these cases, erythropoietin is used to replace the missing hormone or to increase red blood cell counts.
F' dawn il- każijiet, erythropoietin jintuża biex jissostitwixxi l- ormon nieqes jew biex iżid l- għadd ta 'ċelloli tad- demm ħomor.
Erythropoietin is also used before surgery to increase the number of red blood cells and help minimise the consequences of blood loss.
Erythropoietin jintuża ukoll qabel kirurġija biex iżid in- numru ta 'ċelloli tad- demm ħomor u jgħin inaqqas kemm jista' jkun il- konsegwenzi ta 'telf ta' demm.
The active substance in Binocrit, epoetin alfa, is a copy of human erythropoietin and works in exactly the same way as the natural hormone to stimulate red blood cell production.
Is- sustanza attiva f' Binocrit, epoetin alfa, hija kopja ta 'erythropoietin umana u taħdem bl- istess mod eżatt tal- ormon naturali biex tistimula l- produzzjoni ta' ċelloli tad- demm ħomor.
The epoetin alfa in Binocrit is produced by a method known as ‘ recombinant DNA technology’: it is made by a cell that has received a gene (DNA), which makes it able to produce epoetin alfa.
Is- sustanza attiva f' Binocrit, epoetin alfa, hija prodotta b' metodu magħruf bħala teknoloġija 'rikombinanti tad- DNA ’: hija magħmula minn batterju li jkun irċieva ġene (DNA) li jagħmilha possibbli li jipproduċi l- epoetin alfa.
How has Binocrit been studied?
Kif ġie studjat Binocrit?
Binocrit was studied to show that it is comparable with the reference medicine, Eprex/ Erypo, in experimental models and in humans.
Binocrit ġie studjat biex juri li huwa komparabbli mal- mediċina ta 'referenza, Eprex/ Erypo, f' mudelli esperimentali u fuq il- bniedem.
Binocrit, injected into a vein, was compared with the reference medicine in one main study involving 479 patients with anaemia caused by kidney problems.
Binocrit, injettat ġol- vina, ġie mqabbel mal- mediċina ta 'referenza fi studju prinċipali wieħed li kien jinvolvi 479 pazjent b' anemija kkawwżata minn mard kroniku tal- kliewi.
All of the patients had been taking Eprex/ Erypo injected into a vein for at least eight weeks before they were either switched to Binocrit or remained on Eprex/ Erypo.
Il- pazjenti kollha kienu qed jieħdu Eprex/ Erypo, injettat ġol- vini, għal mill- inqas timen ġimgħat qabel ma nqelbu jew għal Binocrit jew baqgħu fuq Eprex/ Erypo.
The main measure of effectiveness was the change in the levels of haemoglobin between the start of the study and the evaluation period, between weeks 25 and 29.
Il- miżura ewlenija tal- effettività kienet il- bidla fil- livelli ta 'emoglobina (protein fiċ- ċelloli tad- demm ħomor li ġġorr l- ossiġenu madwar il- ġisem) bejn il- bidu tal- istudju u l - perjodu ta' evalwazzjoni, bejn il- ġimgħat 25 u 29.
The company also presented the results of a study comparing the effects of Binocrit injected under the skin with those of Eprex/ Erypo in 114 cancer patients who were receiving chemotherapy.
Il- kumpanija ppreżentat ukoll studju li jqabbel l- effetti ta 'Binocrit injettat taħt il- ġilda ma' dawk ta 'Eprex/ Erypo f' 114- il pazjent b' kanċer li kienu qed jirċievu kimoterapija.
What benefit has Binocrit shown during the studies?
X' benefiċċji ta 'Binocrit intwerew f' dawn l- istudji?
Binocrit was as effective as Eprex/ Erypo in increasing and maintaining red blood cell counts.
Binocrit kien effettiv daqs Eprex/ Erypo fiż- żieda u fiż- żamma tal- għadd ta 'ċelloli tad- demm ħomor.
In the study of patients with anaemia caused by kidney problems, patients switching to Binocrit maintained haemoglobin levels to the same extent as those continuing to take Eprex/ Erypo.
Fl- istudju ta 'pazjenti b' anemija kkawżata minn problemi tal- kliewi, il- pazjenti li qelbu għal fuq Binocrit żammew livelli ta' emoglobina daqs dawk li baqgħu jieħdu Eprex/ Erypo.
On average, the levels of the patients taking Binocrit increased by 0.147 g/ dl from a starting value of 11.7 g/ dl.
Bħala medja, il - livelli tal- pazjenti li kienu qegħdin jieħdu Binocrit żdiedu bi 0. 147 g/ dl minn valur tal- bidu ta '11. 7 g/ dl.
In comparison, those continuing to take Eprex/ Erypo had an increase of 0.063 g/ dl from a starting value of 12.0 g/ dl.
Dawk li baqgħu jieħdu Eprex/ Erypo kellhom żieda ta '0. 063 g/ dl minn valur tal- bidu ta' 12. 0 g/ dl.
The study in patients receiving chemotherapy showed that Binocrit was also as effective as Eprex/ Erypo when it was injected under the skin.
L- istudju f' pazjenti li kienu qed jirċievu kimoterapija wera li Binocrit kien effettiv daqs Eprex/ Erypo meta ġie injettat taħt il- ġilda.
What is the risk associated with Binocrit?
X' inhu r- riskju assoċjat ma 'Binocrit?
The most common side effect with Binocrit is an increase in blood pressure, which can sometimes lead to symptoms of encephalopathy (brain problems) such as sudden, stabbing migraine-like headache and confusion.
L- aktar effett sekondarju komuni b' Binocrit kien żieda fil- pressjoni tad- demm, li xi kultant tista 'twassal għal sintomi ta' enċefalopatija (problemi fil- moħħ) bħal uġigħ ta 'ras simili għal emikranja (simili għal daqqiet ta' sikkina) u konfużjoni.
Binocrit can also lead to skin rash and flu-like symptoms.
Binocrit jista 'jwassal ukoll għal raxx tal- ġilda u għal sintomi simili għal dawk tal- influwenza.
For the full list of all side effects reported with Binocrit, see the Package Leaflet.
Għal- lista sħiħa tal- effetti sekondarji rrappurtati ma 'Binocrit, ara l- Fuljett ta' Tagħrif.
Binocrit should not be used in people who may be hypersensitive (allergic) to epoetin alfa or any of the other ingredients.
Binocrit m' għandux jintuża minn persuni li huma sensittivi żżejjed (allerġiċi) għal epoetin alfa jew għal xi sustanza oħra tiegħu.
It must not be used in the following groups: • patients who have developed pure red cell aplasia (reduced or stopped red blood cell production) following treatment with any erythropoietin; • patients with high blood pressure that is not controlled; • patients who are going to donate their own blood who have had a heart attack or stroke within the last month, who have angina pectoris (a severe type of chest pain) or who are at risk of deep venous thrombosis (DVT: formation of blood clots in the deep veins of the body, usually in the leg); 2/ 3 • patients who cannot receive medicines for the prevention of blood clots; • patients about to undergo major orthopaedic surgery who have severe cardiovascular (heart and blood vessel) problems including a recent heart attack or stroke.
2/ 3 • pazjenti li żviluppaw aplasija pura ta 'ċelloli ħomor (produzzjoni mnaqqsa jew imwaqqfa ta' ċelloli tad- demm ħomor) wara trattament bi kwalunkwe erythropoietin, • pazjenti bi pressjoni tad- demm għolja li m' hijiex ikkontrollata, • pazjenti li ser jagħtu d- demm li kellhom attakk tal- qalb jew puplesija matul l- aħħar xahar, li għandhom angina pectoris (uġiegħ qawwi fis- sider) jew li huma f’ riskju ta ’ trombożi fil- vini fil - fond (DVT: formazzjoni ta ’ emboli fil- vini fond ital- ġisem, normalment fir- riġel); • pazjenti li ma jistgħux jirċievu mediċini għall- prevenzjoni ta 'emboli tad- demm, • pazjenti li ser ssirilhom kirurġija ortopedika ta ’ natura serja, li jbagħtu minn problemi kardjovaskulari (vini tad- demm jew tal- qalb) serji inkluż attakk tal- qalb reċenti jew puplesija.
Binocrit is not recommended for injection under the skin in the treatment of kidney problems because further studies are needed to make sure that this does not cause allergic reactions.
Binocrit m' huwiex irrakkomandat għal injezzjoni taħt il- ġilda fit- trattament ta 'problemi tal- kliewi minħabba li hemm bżonn li jsiru aktar studji sabiex ikun żgurat li dan ma jikkawżax reazzjonjiet allerġiċi.
Why has Binocrit been approved?
Għaliex ġie approvat Binocrit?
The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Binocrit has been shown to have a comparable quality, safety and efficacy profile to Eprex/ Erypo.
Il- Kumitat għall- Prodotti Mediċinali għal Użu mill- Bniedem (CHMP) ikkonkluda li, skond ir - rekwiżiti tal- UE, Binocrit intwera li għandu profil ta 'kwalità, sigurtà u effiċjenza komparabbli għal Eprex/ Erypo.
Therefore, the CHMP’ s view was that, as for Eprex/ Erypo, the benefit outweighs the identified risks.
Għalhekk, l- opinjoni tal- CHMP kienet li, bħal Eprex/ Erypo, il- benefiċċju jisboq ir- riskji identifikati.
The Committee recommended that Binocrit be given marketing authorisation.
Il- Kumitat irrakkomanda li Binocrit jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Which measures are being taken to ensure the safe use of Binocrit?
X’ miżuri qegħdin jittieħdu biex ikun żgurat l- użu sigur ta ’ Binocrit?
The company that makes Binocrit will provide information packs for healthcare workers in all Member States, including information on the safety of the medicine.
Il- kumpanija li tagħmel Binocrit sejra tipprovdi pakketti ta 'informazzjoni għall- ħaddiema fil- qasam tal- kura tas- saħħa fl- Istati Membri kollha, inkluż informazzjoni dwar is- sigurtà tal- mediċina.
The company will also provide cool boxes for patients, which will include illustrations showing how the medicine should be used.
Il - kumpanija sejra tipprovdi ukoll cool boxes għall- pazjenti, li jinkludu stampi li juru kif għandha tintuża l- mediċina.
Other information about Binocrit:
Tagħrif ieħor dwar Binocrit:
The European Commission granted a marketing authorisation valid throughout the EU for Binocrit to Sandoz GmbH on 28 August 2007.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq għal Binocrit valida fl- Unjoni Ewropea kollha lil Sandoz GmbH fil- 28 ta 'Awissu 2007.
The full EPAR for Binocrit can be found here.
L- EPAR sħiħ għal Binocrit jinsab hawn.
This summary was last updated in 12-2008.
Dan is- sommarju ġie aġġornat l- aħħar f' 12- 2008.
EU Number
Numru ta ’ l- EU
Invented name
Isem ivvintat
Strength
Qawwa
Pharmaceutical Form
Għamla farmaċewtika
Route of Administration
Mnejn jingħata
Packaging
Il- pakkett
Content
Kontenut
Package size
Daqs tal- pakkett
Solution for injection in a pre-filled syringe
Soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest
Subcutaneous or intravenous use
Użu għal taħt il - ġilda jew għal ġol - vini
pre-filled syringe (glass)
siringa mimlija għal- lest (ħġieġ)
0.5 ml (2000 IU/ ml)
0. 5 ml (2000 IU/ ml)
1 pre-filled syringe
Siringa 1 mimlija għal- lest
6 pre-filled syringes
6 siringi mimlijin għal- lest
1.0 ml (2000 IU/ ml)
1. 0 ml (2000 IU/ ml)
6 pre-filled syringes
6 siringi mimlijin għal- lest Siringa 1 mimlija
Solution for injection in a pre-filled syringe
Soluzzjoni għall- injezzjoni
Subcutaneous or intravenous use
Użu għal taħt il -
pre-filled syringe (glass)
siringa mimlija
1 pre-filled syringe
għal- lest
6 pre-filled syringes
6 siringi mimlijin
0.4 ml (10000 IU/ ml)
0. 4 ml (10000 IU/ ml)
1 pre-filled syringe
Siringa 1 mimlija
0.5 ml (10000 IU/ ml)
0. 5 ml (10000 IU/ ml)
0.6 ml (10000 IU/ ml)
0. 6 ml (10000 IU/ ml)
0.8 ml (10000 IU/ ml)
0. 8 ml (10000 IU/ ml)
1.0 ml (10000 IU/ ml)
1. 0 ml (10000 IU/ ml)
0.7 ml (10000 IU/ ml)
0. 7 ml (10000 IU/ ml)
0.7 ml
0. 7 ml
0.9 ml (10000 IU/ ml)
0. 9 ml (10000 IU/ ml)
SUMMARY OF PRODUCT CHARACTERISTICS
SOMMARJU TAL- KARATTERISTIĊI TAL- PRODOTT
Binocrit 1000 IU/ 0.5 ml solution for injection in a pre-filled syringe
Binocrit 1000 IU/ 0. 5 ml soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest
Each ml of solution contains 2000 IU of epoetin alfa* corresponding to 16.8 micrograms per ml 1 pre-filled syringe of 0.5 ml contains 1000 international units (IU) corresponding to 8.4 micrograms epoetin alfa
Kull ml ta ’ soluzzjoni fih 2000 IU ta ’ epoetin alfa * li jikkorrispondu għal 16. 8 mikrogrammi f’ kull ml Siringa mimlija għal- lest ta ’ 0. 5 ml fiha 1000 unità internazzjonali (IU) li jikkorrispondu għal 8. 4 mikrogrammi ta ’ epoetin alfa
* Produced in CHO cell line by recombinant DNA technology
* Magħmul f’ linja ta ’ ċelluli CHO b’ teknoloġija tad- DNA rikombinanti
For a full list of excipients, see section 6.1.
Għal- lista kompleta ta ’ sustanzi mhux attivi, ara sezzjoni 6. 1.
PHARMACEUTICAL FORM
GĦAMLA FARMAĊEWTIKA
Solution for injection in a pre-filled syringe (injection)
Soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest (injezzjoni)
Clear colourless solution
Soluzzjoni ċara bla kulur
CLINICAL PARTICULARS
TAGĦRIF KLINIKU
4.1 Therapeutic indications
4. 1 Indikazzjonijiet terapewtiċi
Treatment of symptomatic anaemia associated with chronic renal failure (CRF) in adult and paediatric patients:
Kura ta ’ anemija sintomatika assoċjata ma ’ insuffiċjenza renali kronika (CRF) f’ pazjenti adulti u pedjatriċi:
- Treatment of anaemia associated with chronic renal failure in paediatric and adult patients on
- Kura ta ’ anemija assoċjata ma ’ insuffiċjenza renali kronika f’ pazjenti pedjatriċi u adulti fuq l -
haemodialysis and adult patients on peritoneal dialysis (See section 4.4).
emodijalisi u f’ pazjenti adulti fuq dijalisi peritonali (Ara sezzjoni 4. 4).
- Treatment of severe anaemia of renal origin accompanied by clinical symptoms in adult patients
- Kura ta ’ anemija severa ta ’ oriġini renali akkumpanjata minn sintomi kliniċi f’ pazjenti adulti
with renal insufficiency not yet undergoing dialysis (See section 4.4).
b’ insuffiċjenza renali li jkunu għadhom mhux qegħdin fuq id- dijalisi (Ara sezzjoni 4. 4).
Treatment of anaemia and reduction of transfusion requirements in adult patients receiving chemotherapy for solid tumours, malignant lymphoma or multiple myeloma, and at risk of transfusion as assessed by the patient's general status (e. g. cardiovascular status, pre-existing anaemia at the start of chemotherapy).
Kura ta ’ anemija u tnaqqis tal- ħtiġijiet ta ’ trasfużjoni f’ pazjenti adulti li jkunu qegħdin jirċievu kimoterapija għal tumuri solidi, limfoma malinna jew majeloma multipla, u li jkunu f’ riskju ta ’ trasfużjoni kif evalwat mill- istat ġenerali tal- pazjent (eż. status kardjovaskulari, anemija diġà eżistenti fil- bidu tal- kimoterapija).
Binocrit can be used to increase the yield of autologous blood from patients in a predonation programme.
Binocrit jista ’ jintuża biex iżid l- ammont ta ’ demm awtologu minn pazjenti fi programm ta ’ predonazzjoni.
Its use in this indication must be balanced against the reported risk of thromboembolic events.
L- użu tiegħu f’ din l- indikazzjoni irid ikun ibbilanċjat kontra r- riskju rrappurtat ta ’ avvenimenti tromboemboliċi.
Treatment should only be given to patients with moderate anaemia (haemoglobin (Hb) 10 – 13 g/ dl [6.2 – 8.1 mmol/ l], no iron deficiency), if blood saving 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 (emoglobina (Hb) 10 - 13 g/ dl [6. 2 - 8. 1 mmol/ l], l- ebda defiċjenza ta ’ ħadid), jekk il- proċeduri li jiffrankaw id- demm ma jkunux disponibbli jew ikunu insuffiċjenti meta operazzjoni skedata maġġuri tkun teħtieġ volum kbir ta ’ demm (4 jew iktar unitajiet ta ’ demm għan- nisa jew 5 jew iktar unitajiet għall- irġiel).
Binocrit can be used to reduce exposure to allogeneic blood transfusions in adult non-iron deficient patients prior to major elective orthopaedic surgery, having a high perceived risk for transfusion complications.
Binocrit jista ’ jintuża sabiex inaqqas l- esponiment għal trasfużjonijiet tad- demm alloġeneiċi f’ pazjenti adulti mhux nieqsa mill- ħadid qabel operazzjoni ortopedika elettiva maġġuri, li jkollhom riskju perċepit għoli ta ’ kumplikazzjonijiet mit- trasfużjoni.
Use should be restricted to patients with moderate anaemia (e. g.
L- użu għandu jkun ristrett għal pazjenti b’ anemija moderata (eż.
Hb 10 - 13 g/ dl) who do not have an autologous predonation programme available and with an expected blood loss of 900 to 1800 ml.
Hb 10 – 13 g/ dl) li ma jkollhomx programm ta ’ predonazzjoni awtologu disponibbli u li jkun mistenni li jkun hemm telf tad- demm ta ’ 900 sa 1800 ml.
4.2 Posology and method of administration
4. 2 Pożoloġija u metodu ta ’ kif għandu jingħata
Treatment with Binocrit has to be initiated under the supervision of physicians experienced in the management of patients with the above indications.
Il- kura b’ Binocrit għandha tinbeda taħt is- superviżjoni ta ’ tobba b’ esperjenza fl- immaniġġar ta ’ pazjenti bis- sintomi msemmija hawn fuq.
2 Posology
2 Pożoloġija
Treatment of symptomatic anaemia in adult and paediatric chronic renal failure patients:
Kura ta ’ anemija sintomatika f’ pazjenti adulti u pedjatriċi li għandhom insuffiċjenza renali kronika:
In patients with chronic renal failure the medicinal product has to be administered intravenously (see section 4.4).
F’ pazjenti b’ insuffiċjenza renali kronika il- prodott mediċinali jrid jingħata minn ġol- vini (ara sezzjoni 4. 4).
The haemoglobin concentration aimed for is between 10 and 12 g/ dl (6.2 - 7.5 mmol/ l), except in paediatric patients in whom the haemoglobin concentration should be between 9.5 and 11 g/ dl (5.9 - 6.8 mmol/ l).
Il- konċentrazzjoni ta ’ emoglobina intenzjonata hi bejn 10 u 12 g/ dl (6. 2 - 7. 5 mmol/ l), ħlief f’ pazjenti pedjatriċi fejn il- konċentrazzjoni ta ’ emoglobina għandha tkun bejn 9. 5 u 11 g/ dl (5. 9 - 6. 8 mmol/ l).
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.
Sintomi ta ’ anemija u l- konsegwenzi tagħha jistgħu jvarjaw ma ’ l- età, sess, u l- gravità totali tal- marda; hemm bżonn ta ’ evalwazzjoni ta ’ tabib tal- kors kliniku u tal- kundizzjoni tal- pazjent individwali.
Binocrit should be administered intravenously in order to increase haemoglobin to not greater than 12 g/ dl (7.5 mmol/ l).
Binocrit għandu jingħata minn ġol- vina sabiex iżid l- emoglobina għal mhux iktar minn 12 g/ dl (7. 5 mmol/ l).
A rise in haemoglobin of greater than 2 g/ dl (1.25 mmol/ l) over a four week period should be avoided.
Żieda fl- emoglobina ta ’ iktar minn 2 g/ dl (1. 25 mmol/ l) fuq perjodu ta ’ erba ’ ġimgħat għandha tkun evitata.
If it occurs, appropriate dose adjustments should be made as provided.
Jekk din isseħħ, għandhom isiru aġġustamenti adattati tad- doża kif meħtieġ.
Due to intra-patient variability, occasional individual haemoglobin values for a patient above and below the desired haemoglobin level may be observed.
Minħabba l- varjabilità bejn il- pazjenti, okkażjonalment jistgħu jkunu osservati figuri ta ’ l- emoglobina aktar għoljin jew aktar baxxi mil- livell mixtieq għal pazjent.
Haemoglobin variability should be addressed through dose management, with consideration for the haemoglobin target range of 10 g/ dl (6.2 mmol/ l) to 12 g/ dl (7.5 mmol/ l).
Il- varjabilità ta ’ l- emoglobina għandha tkun indirizzata permezz ta ’ l- immaniġġjar tad- doża, b’ konsiderazzjoni għall- mira ta ’ medda ta ’ l - emoglobina ta ’ 10 g/ dl (6. 2 mmol/ l) sa 12 g/ dl (7. 5 mmol/ l).
In paediatric patients the recommended target haemoglobin range is between 9.5 and 11 g/ dl (5.9 - 6.8 mmol/ l).
F’ pazjenti pedjatriċi, il- mira rakkomandata tal- medda ta ’ l- emoglobina hi ta ’ bejn 9. 5 u 11 g/ dl (5. 9 - 6. 8 mmol/ l).
A sustained haemoglobin level of greater than 12 g/ dl (7.5 mmol/ l) should be avoided.
Livell sostnut ta ’ emoglobina ta ’ iktar minn 12 g/ dl (7. 5 mmol/ l) għandu jkun evitat.
If the haemoglobin is rising by more than 2 g/ dl (1.25 mmol/ l) per month, or if the sustained haemoglobin exceeds 12 g/ dl (7.5 mmol/ l) reduce the epoetin alfa dose by 25%.
Jekk l - emoglobina tkun qed tiżdied b’ iktar minn 2 g/ dl (1. 25 mmol/ l) kull xahar, jew jekk il- livell sostnut ta ’ emoglobina jaqbeż 12 g/ dl (7. 5 mmol/ l), naqqas id- doża ta ’ epoetin alfa b’ 25%.
If the haemoglobin exceeds 13 g/ dl (8.1 mmol/ l), discontinue therapy until it falls below 12 g/ dl (7.5 mmol/ l) and then reinstitute epoetin alfa therapy at a dose 25% below the previous level.
Jekk l- emoglobina taqbeż 13 g/ dl (8. 1 mmol/ l), waqqaf it- terapija sakemm il- livell jinżel taħt 12 g/ dl (7. 5 mmol/ l), u mbagħad erġa ’ ibda t- terapija b’ epoetin alfa b’ doża li tkun 25% taħt il- livell ta ’ qabel.
Patients should be monitored closely to ensure that the lowest approved dose of Epoetin alfa is used to provide adequate control of anaemia and of the symptoms of anaemia.
Il- pazjenti għandhom ikunu mmonitorjati mill- qrib biex ikun żgurat li tintuża l- inqas doża approvata ta ’ Epoetin alfa biex tipprovdi kontroll adegwat ta ’ l- anemija u tas- sintomi ta ’ l- anemija.
Iron status should be evaluated prior to and during treatment and iron supplementation administered if necessary.
L- istatus tal- livell ta ’ ferritin għandu jiġi evalwat qabel u matul il- kura u jingħata suppliment ta ’ ħadid jekk ikun meħtieġ.
In addition, other causes of anaemia, such as vitamin B12 or folate deficiency, should be excluded before instituting therapy with epoetin alfa.
Barra minn hekk, kawżi oħra ta ’ anemija, bħal defiċjenza ta ’ vitamina B12 jew ta ’ folate, għandhom jiġu esklużi qabel ma tinbeda terapija b’ epoetin alfa.
Non response to epoetin alfa therapy may have the following causes: iron, folate, or vitamin B12 deficiency; aluminium intoxication; intercurrent infections; inflammatory or traumatic episodes; occult blood loss; haemolysis, and bone marrow fibrosis of any origin.
In- nuqqas ta ’ respons għal terapija b’ epoetin alfa jista ’ jkollu l- kawżi li ġejjin: defiċjenza ta ’ ħadid, folate jew vitamina B12; avvelenament bl- aluminju; infezzjonijiet li jitfaċċaw minn żmien għal ieħor; episodji infjammatorji jew trawmatiċi; telf ta ’ demm li ma jidhirx; l- emodijalisi u fibrożi tal- mudullun ta ’ kwalunkwe oriġini.
Adult haemodialysis patients:
Pazjenti adulti fuq l- emodijalisi:
The treatment is divided into two stages:
Il- kura hija maqsuma f’ żewġ fażijiet:
Correction phase:
Fażi ta ’ korrezzjoni:
50 IU/ kg 3 times per week by the intravenous route.
50 IU/ kg 3 darbiet fil- ġimgħa mogħtija minn ġol- vini.
When a dose adjustment is necessary, this should be done in steps of at least four weeks.
Meta jkun hemm bżonn ta ’ aġġustament fid - doża, dan għandu jsir fi stadji ta ’ mill- anqas erba ’ ġimgħat.
At each step, the increase or reduction in dose should be of 25 IU/ kg 3 times per week.
F’ kull stadju, iż- żieda jew tnaqqis fid- doża għandu jkun ta ’ 25 IU/ kg 3 darbiet fil- ġimgħa.
Maintenance phase:
Fażi ta ’ manteniment:
Dose adjustment in order to maintain haemoglobin values at the desired level:
Aġġustament fid- doża sabiex il- figuri ta ’ l- emoglobina jinżammu fil- livell mixtieq:
Hb between 10 and 12 g/ dl (6.2 - 7.5 mmol/ l).
Hb bejn 10 u 12 g/ dl (6. 2 - 7. 5 mmol/ l).
The recommended total weekly dose is between 75 and 300 IU/ kg given by the intravenous route.
Id- doża totali rakkomandata fil- ġimgħa hija bejn 75 u 300 IU/ kg mogħtija minn ġol- vini.
The clinical data available suggest that those patients whose initial haemoglobin is very low (< 6 g/ dl or< 3.75 mmol/l) may require higher maintenance doses than those whose initial anaemia is less severe (Hb > 8 g/dl or> 5 mmol/l).
L- informazzjoni klinika disponibbli tissuġġerixxi li dawk il- pazjenti li l- emoglobina inizjali tagħhom tkun baxxa ħafna (< 6 g/ dl jew < 3. 75 mmol/ l) jistgħu jkunu jeħtieġu dożi ta ’ manteniment ogħla minn dawk li l- anemija inizjali tagħhom tkun anqas severa (Hb > 8 g/ dl jew > 5 mmol/ l).
Paediatric haemodialysis patients:
Pazjenti pedjatriċi fuq l- emodijalisi:
50 IU/ kg 3 times per week by the intravenous route.
3 Fażi ta ’ korrezzjoni 50 IU/ kg 3 darbiet fil- ġimgħa minn ġol- vina.
When a dose adjustment is necessary, this should be done in steps of 25 IU/ kg 3 times per week at intervals of at least 4 weeks until the desired goal is achieved.
Meta jkun hemm bżonn ta ’ aġġustament fid- doża, dan għandu jsir fi stadji ta ’ 25 IU/ kg 3 darbiet fil- ġimgħa b’ intervalli ta ’ mill- anqas 4 ġimgħat sakemm tintlaħaq il- mira mixtieqa.
Hb between 9.5 and 11 g/ dl (5.9 - 6.8 mmol/ l).
Hb bejn 9. 5 u 11 g/ dl (5. 9 - 6. 8 mmol/ l).
Generally, children under 30 kg require higher maintenance doses than children over 30 kg and adults.
Ġeneralment, tfal li jiżnu anqas minn 30 kg ikunu jeħtieġu dożi ta ’ manteniment ogħla minn tfal li jiżnu aktar minn 30 kg u l- adulti.
The following maintenance doses were observed in clinical trials after 6 months of treatment:
Id- dożi ta ’ manteniment li ġejjin ġew osservati fi provi kliniċi wara 6 xhur ta ’ kura:
Dose (IU/ kg given 3x / week)
Doża (IU/ kg mogħtija 3x / ġimgħa)
Weight (kg )< 10 10 - 30 > 30
Piż (kg) < 10 10 - 30 > 30
Median 100 75 33
Medjan 100 75 33
Usual maintenance dose 75 - 150 60 - 150 30 - 100
Doża normali mantenuta 75 - 150 60 - 150 30 - 100
The clinical data available suggest that those patients whose initial haemoglobin is very low (< 6.8 g/ dl or< 4.25 mmol/l) may require higher maintenance doses than those whose initial anaemia is less severe (Hb > 6.8 g/dl or> 4.25 mmol/l).
L- informazzjoni klinika disponibbli tissuġġerixxi li dawk il- pazjenti li l- emoglobina inizjali tagħhom tkun baxxa ħafna (< 6. 8 g/ dl jew < 4. 25 mmol/ l) jistgħu jkunu jeħtieġu dożi ta ’ manteniment ogħla minn dawk li l- anemija inizjali tagħhom tkun anqas severa (Hb > 6. 8 g/ dl jew > 4. 25 mmol/ l).
Adult peritoneal dialysis patients:
Pazjenti adulti fuq dijalisi peritonali:
Starting dose of 50 IU/ kg 2 times per week by the intravenous route.
Doża inizjali ta ’ 50 IU/ kg darbtejn fil- ġimgħa mogħtija minn ġol- vini.
Maintenance dose between 25 and 50 IU/ kg 2 times per week into 2 equal injections.
Doża ta ’ manteniment bejn 25 u 50 IU/ kg darbtejn fil- ġimgħa f’ żewġ injezzjonijiet ugwali.
Adult patients with renal insufficiency not yet undergoing dialysis:
Pazjenti adulti b’ insuffiċjenza tal- kliewi li jkunu għadhom mhux qegħdin fuq id- dijalisi:
Starting dose of 50 IU/ kg 3 times per week by the intravenous route, followed if necessary by a dose increase with 25 IU/ kg increments (3 times per week) until the desired goal is achieved (this should be done in steps of at least four weeks).
Doża inizjali ta ’ 50 IU/ kg 3 darbiet fil- ġimgħa mogħtija minn ġol- vini, segwita jekk ikun hemm bżonn minn żieda fid- doża b’ inkrementi ta ’ 25 IU/ kg (3 darbiet fil- ġimgħa) sakemm tintlaħaq il- mira mixtieqa (dan għandu jsir fi stadji ta ’ mill- anqas erba ’ ġimgħat).
Maintenance dose between 17 and 33 IU/ kg 3 times per week by the intravenous route.
Doża ta ’ manteniment bejn 17 u 33 IU/ kg 3 darbiet fil- ġimgħa mogħtija minn ġol- vini.
The maximum dose should not exceed 200 IU/ kg 3 times per week.
Id- doża massima m’ għandhiex taqbeż 200 IU/ kg 3 darbiet fil- ġimgħa.
Treatment of patients with chemotherapy induced anaemia:
Kura ta ’ pazjenti b’ anemija kkawżata mill- kimoterapija:
Epoetin alfa should be administered by the subcutaneous route to patients with anaemia (e. g. haemoglobin concentration ≤ 10 g/ dl (6.2 mmol/ l).
Epoetin alfa għandu jingħata taħt il- ġilda lil pazjenti b’ anemija (eż. konċentrazzjoni ta ’ emoglobina ta ’ ≤ 10 g/ dl (6. 2 mmol/ l).
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.
Sintomi ta ’ anemija u l- konsegwenzi tagħha jistgħu jvarjaw skond l- età, is - sess, u l- gravità totali tal- marda; hemm bżonn ta ’ evalwazzjoni ta ’ tabib tal- kors kliniku u tal - kundizzjoni tal- pazjent individwali.
A sustained haemoglobin level of greater than 12 g/ dl (7.5 mmol/ l) should be
Il- varjabilità ta ’ l- emoglobina għandha tkun indirizzata permezz ta ’ l- immaniġġjar tad- doża, b’ konsiderazzjoni għall- mira tal medda ta ’ l - emoglobina ta ’ 10 g/ dl (6. 2 mmol/ l) sa 12 g/ dl (7. 5 mmol/ l).
4 avoided; guidance for appropriate dose adjustment for when haemoglobin values exceeding 12 g/ dl (7.5 mmol/ l) are observed are described below.
Livell sostnut ta ’ emoglobina ta ’ iktar 4 minn 12 g/ dl (7. 5 mmol/ l) għandu jkun evitat; gwida għal aġġustament adattat tad- doża għal meta jkunu osservati figuri ta ’ l- emoglobina li jaqbżu 12 g/ dl (7. 5 mmol/ l), huma deskritti hawn taħt.
Patients should be monitored closely to ensure that the lowest approved dose of Epoetin alfa is used to provide adequate control of the symptoms of anaemia.
Il- pazjenti għandhom ikunu mmonitorjati mill- qrib biex ikun żgurat li tintuża l- inqas doża approvata ta ’ Epoetin alfa biex tipprovdi kontroll adegwat tas- sintomi ta ’ l- anemija.
Epoetin alfa therapy should continue until one month after the end of chemotherapy.
It- terapija b’ epoetin alfa għandha tkompli sa xahar wara t- tmiem tal- kimoterapija.
The initial dose is 150 IU/ kg given subcutaneously 3 times per week.
Id- doża inizjali hi 150 IU/ kg mogħtija minn taħt il- ġilda 3 darbiet fil- ġimgħa.