qanastek/EMEA-V3 huggingface dataset:
Stability of the reconstituted suspension in the vial After first reconstitution, the suspension should be filled into an infusion bag immediately.
25 L- istabbiltà tas- suspensjoni rrikostitwita fil- vjala Wara l- ewwel rikostituzzjoni, is- suspensjoni għandha timtela f’ borża ta ’ l- infużjoni immedjatament.
Stability of the reconstituted suspension in the infusion bag After reconstitution, the reconstituted suspension in the infusion bag should be used immediately.
L- istabbiltà tas- suspensjoni rikostitwita fil- borża ta ’ l- infużjoni Wara r- rikostituzzjoni, is- suspensjoni fil- borża ta ’ l- infużjoni għandha tintuża immedjatament.
However chemical and physical in use stability has been demonstrated for 8 hours not above 25°C.
Madankollu, l- istabbiltà kimika u fiżika tibqa ’ tajba sa 8 sigħat f’ temperatura ta ’ mhux iktar minn 25°C.
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 Abseamed 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 Abseamed 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
This document is a summary of the European Public Assessment Report (EPAR).
Dan id- dokument huwa sommarju tar- Rapport Pubbliku Ewropew ta ’ Valutazzjoni Pubbliku Ewropew (EPAR).
What is Abseamed?
X' inhu Abseamed?
Abseamed is a solution for injection.
Abseamed huwa soluzzjoni għal injezzjoni.
Abseamed is a ‘ biosimilar’ medicine.
Abseamed huwa mediċina ‘ bijosimili ’.
This means that Abseamed 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 Abseamed 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 Abseamed is Eprex/ Erypo.
Il- mediċina ta 'referenza għal Abseamed hija Eprex/ Erypo.
What is Abseamed used for?
Għal xiex jintuża Abseamed?
Abseamed 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 take 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.
Abseamed jintuża fis- sitwazzjonijiet li ġejjin: • biex jitratta anemija (għadd baxx ta 'ċelloli tad- demm ħomor) li tikkawża sintomi f’ pazjenti b’ insuffiċjenza kronika tal- kliewi (tnaqqis progressiv, fit- tul fil- kapaċità 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 meħud minn pazjenti adulti b’ anemija moderata li jkun ser ikollhom operazzjoni u jagħtu demmhom stess qabel intervent kirurġiku (trasfużjoni tad - demm awtologa), • biex inaqqas il- ħtieġa ta' trasfużjonijiet tad- demm fl- adulti b' anemija ħafifa li jkunu se jagħmlu intervent kirurġiku ortopediku (tal- għadam) ta ’ natura serja, bħal intervent kirurġiku fuq il - ġenbejn.
How is Abseamed used?
Kif jintuża Abseamed?
Abseamed can be injected under the skin by the patient or their carer if they
It- trattament b' Abseamed għandu jinbeda taħt is- sorveljanza ta 'tabib li għandu esperjenza fil- ġestjoni ta' pazjenti bil- kundizzjonijiet li l- mediċina hija użata għalihom.
The dose, the frequency of injection and how long it is used for depend on why Abseamed is being used, and are adjusted according to the patient’ s response.
Għal pazjenti bi problemi tal- kliewi u pazjenti li ser jagħtu demmhom stess, Abseamed għandu jiġi injettat ġol- vini.
Haemoglobin is the protein in red blood cells that carries oxygen around the body.
L- emoglobina hija l- proteina fiċ - ċelloli ħomor tad- demm li jġorru l- ossiġenu madwar il- ġisem.
For these patients, the lowest dose that provides adequate control of symptoms should be used.
Għal dawn il- pazjenti, għandha tintuża l- aktar doża baxxa li tipprovdi kontroll xieraq tas- sintomi.
How does Abseamed work?
Kif jaħdem Abseamed?
The active substance in Abseamed, 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' Abseamed, 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 Abseamed is produced by ‘ recombinant DNA technology’: it is made by a cell that has received a gene (DNA), which makes it able to produce epoetin alfa.
Epoetin alfa f' Abseamed hija prodotta b' metodu magħruf bħala ‘ teknoloġija tad- DNA rikombinanti ’: hija magħmula minn batterju li jkun irċieva ġene (DNA) li jagħmilha possibbli li jipproduċi l- epoetin alfa.
How has Abseamed been studied?
Kif ġie studjat Abseamed?
Abseamed was studied to show that it is comparable with the reference medicine, Eprex/ Erypo, in experimental models and in humans.
Abseamed ġie studjat biex juri li huwa komparabbli mal- mediċina ta 'referenza, Eprex/ Erypo, f' mudelli sperimentali u fuq il- bniedem.
Abseamed, injected into a vein, was compared with the reference medicine in one main study involving 479 patients with anaemia caused by kidney problems.
Abseamed, injettat ġol- vina, tqabbel mal- mediċina ta 'referenza fi studju prinċipali wieħed li kien jinvolvi 479 pazjent b' anemija kkawżata minn problemi kroniċi 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 Abseamed or remained on Eprex/ Erypo.
Il- pazjenti kollha kienu qed jieħdu Eprex/ Erypo, injettat ġol- vini, għal mill- inqas tmien ġimgħat qabel ma nqalbu jew għal Abseamed 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- kejl ewlieni tal- effikaċja kien il- bidla fil- livelli ta 'emoglobina 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 Abseamed 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 'Abseamed injettat taħt il- ġilda ma' dawk ta 'Eprex/ Erypo f' 114- il pazjent b' kanċer li kienu qed jirċievu kimoterapija.
What benefit has Abseamed shown during the studies?
X' benefiċċji ta 'Abseamed intwerew f' dawn l- istudji?
Abseamed was as effective as Eprex/ Erypo in increasing and maintaining red blood cell counts.
Abseamed kien effikaċi 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 Abseamed 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 qalbu għal fuq Abseamed żammew livelli ta' emoglobina daqs dawk li baqgħu jieħdu Eprex/ Erypo.
On average, the levels of the patients taking Abseamed 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 Abseamed żdiedu bi 0. 147 g/ dl minn valur tal- bidu ta '11. 7 g/ dl.
The study in patients receiving chemotherapy showed that Abseamed 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 Abseamed kien effikaċi daqs Eprex/ Erypo meta ġie injettat taħt il- ġilda.
What is the risk associated with Abseamed?
X' inhu r- riskju assoċjat ma 'Abseamed?
The most common side effect with Abseamed 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' Abseamed 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 għall- għarrieda) u konfużjoni.
Abseamed can also lead to skin rash and flu-like symptoms.
Abseamed 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 Abseamed, see the Package Leaflet.
Għal- lista sħiħa tal- effetti sekondarji rrappurtati ma 'Abseamed, ara l- Fuljett ta' Tagħrif.
Abseamed should not be used in people who may be hypersensitive (allergic) to epoetin alfa or any of the other ingredients.
2/ 3 Abseamed m' għandux jintuża minn persuni li jistgħu jkunu ipersensittivi 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 2/ 3 venous thrombosis (DVT: formation of blood clots in the deep veins of the body, usually in the leg); • 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.
Ma għandux jintuża wkoll fil- gruppi li ġejjin: • 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 tagħhom stess li kellhom attakk tal- qalb jew puplesija matul l- aħħar xahar, li għandhom angina pectoris (uġigħ 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 intervent kirurġiku ortopediku ta ’ natura serja, li jbagħtu minn problemi kardjovaskulari (vini u arterji tad- demm jew tal- qalb) serji inkluż attakk tal- qalb jew puplesija reċenti.
Abseamed 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.
Abseamed 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 Abseamed been approved?
Għaliex ġie approvat Abseamed?
The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Abseamed has been shown to have a comparable quality, safety and efficacy profile to Eprex/ Erypo.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) ikkonkluda li, skont ir - rekwiżiti tal- UE, Abseamed intwera li għandu profil ta 'kwalità, sigurtà u effikaċja komparabbli għal Eprex/ Erypo.
Therefore, the CHMP’ s view was that, as for Eprex/ Erypo, the benefit outweighs the identified risks.
Għalhekk, l- opinjoni tas- CHMP kienet li, bħal Eprex/ Erypo, il- benefiċċju huwa akbar mir- riskji identifikati.
The Committee recommended that Abseamed be given marketing authorisation.
Il- Kumitat irrakkomanda li Abseamed jingħata awtorizzazzjoni għat- tqegħid fis - suq.
Which measures are being taken to ensure the safe use of Abseamed?
X’ miżuri qegħdin jittieħdu biex ikun żgurat l- użu sigur ta ’ Abseamed?
The company that makes Abseamed will provide information packs for healthcare workers in all Member States, including information on the safety of the medicine.
Il- kumpanija li tipproduċi Abseamed 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 kessieħa (cool boxes) għall- pazjenti, li jinkludu stampi li juru kif għandha tintuża l- mediċina.
Other information about Abseamed:
Tagħrif ieħor dwar Abseamed:
The European Commission granted a marketing authorisation valid throughout the EU for Abseamed to Medice Arzneimittel Pütter GmbH & Co KG on 28 August 2007.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq għal Abseamed valida fl- Unjoni Ewropea kollha lil Medice Arzneimittel Pütter GmbH & Co KG fit- 28 ta 'Awwissu 2007.
The full EPAR for Abseamed can be found here.
L- EPAR sħiħ għal Abseamed jista ’ jiġi kkonsultat hawnhekk.
Solution for injection in a pre-filled syringe
Soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest 1/ 2
Abseamed can be used to increase the yield of autologous blood from patients in a predonation programme.
Abseamed jista ’ jintuża biex iżid l- ammont ta ’ demm awtologu minn pazjenti fi programm ta ’ predonazzjoni.
Abseamed 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.
Abseamed 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.
4.2 Posology and method of administration
2 Pożoloġija
Abseamed should be administered intravenously in order to increase haemoglobin to not greater than 12 g/ dl (7.5 mmol/ l).
Abseamed għandu jingħata minn ġol- vina sabiex iżid l- emoglobina għal mhux iktar minn 12 g/ dl (7. 5 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 kundizzjonijiet 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.
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 tal medda ta ’ 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 minn 12 g/ dl (7. 5 mmol/ l) għandu jkun evitat; gwida għal aġġustament adattat tad- doża għal meta jkunu osservati fuguri ta ’ l- emoglobina li jaqbżu 12 g/ dl (7. 5 mmol/ l), huma deskritti hawn taħt.
Abseamed should be given by the intravenous route.
Abseamed għandu jingħata ġol- vini.
At the time of donating blood, Abseamed should be administered after the completion of the blood donation procedure.
Meta jingħata d- demm, Abseamed għandu jingħata wara li titlesta l- proċedura tal- għoti tad- demm.
Mildly anaemic patients (haematocrit of 33 - 39%) requiring predeposit of ≥ 4 units of blood should be treated with Abseamed at a dose of 600 IU/ kg body weight 2 times weekly for 3 weeks prior to surgery.
Pazjenti li għandhom anemija ħafifa (ematokrit ta ’ 33 - 39%) li jeħtieġu predepożitu ta ’ ≥ 4 unitajiet ta ’ demm, għandhom jiġu kkurati b’ Abseamed b’ doża ta ’ 600 IU għal kull kilogramm ta ’ piż tal- ġisem darbtejn fil- ġimgħa għal 3 ġimgħat qabel l- operazzjoni.
All patients being treated with Abseamed should receive adequate iron supplementation (e. g.
Il- pazjenti kollha li jkunu qed jiġu kkurati b’ Abseamed għandhom jirċievu supplimentazzjoni adegwata tal- ħadid (eż.
200 mg oral elemental iron daily) throughout the course of treatment.
200 mg - ħadid elementali orali kuljum) matul il- kors tal- kura.
Iron supplementation should be started as soon as possible, even several weeks prior to initiating the autologous predeposit, in order to achieve high iron stores prior to starting Abseamed therapy.
Is - supplimentazzjoni tal- ħadid għandha tinbeda kemm jista ’ jkun malajr, anki diversi ġimgħat qabel ma tibda l- predepożitu awtologu, sabiex ikollok ħażna kbira ta ’ qabel ma tibda t- terapija b’ Abseamed.
Abseamed is a sterile but unpreserved product and is for single use only.
Abseamed huwa prodott sterili iżda mhux ippreservat u jintuża darba biss.
In chronic renal failure patients Abseamed has not to be administered subcutaneously!
F’ pazjenti b’ insuffiċjenza renali kronika, Abseamed m’ għandux jingħata taħt il- ġilda!
Patients who develop Pure Red Cell Aplasia (PRCA) following treatment with any erythropoietin should not receive Abseamed or any other erythropoietin (see section 4.4 - Pure Red Cell Aplasia).
Pazjenti li jiżviluppaw Aplasja taċ- Ċelluli l- Ħomor tad- Demm Pura (PRCA) wara kura b’ xi eritropoetin, m’ għandhomx jingħataw Abseamed jew xi eritropoetin ieħor (ara sezzjoni 4. 4 – Aplasja taċ- Ċelluli l- Ħomor tad- Demm Pura).
If anti-erythropoietin, antibody-mediated PRCA is suspected, therapy with Abseamed should be discontinued immediately.
Jekk tkun issuspettata PRCA medjata b’ antikorpi kontra l- eritropoetin, it- terapija b’ Abseamed għandha titwaqqaf immedjatament.
No other erythropoietic therapy should be commenced because of the risk of cross-reaction.
M’ għandha tinbeda l- ebda terapija erythropoietic oħra minħabba r - riskju ta ’ cross- reaction.
Immunogenicity data for subcutaneous use of Abseamed in patients at risk for antibody-induced PRCA, i. e. patients with renal anaemia, are not sufficient.
Informazzjoni dwar l- immunoġeniċità għall- użu minn taħt il- ġilda ta ’ Abseamed f’ pazjenti f’ riskju għal PRCA ikkawżata mill- antikorpi, i. e. pazjenti b’ anemija renali, mhix suffiċjenti.
patients with metastatic breast cancer receiving chemotherapy when administered to target a haemoglobin of 12 - 14 g/ dl (7.5 – 8.7 mmol/ l),
4 xhur f’ pazjenti b’ kanċer metastatiku tas- sider li jkunu qed jirċievu kimoterapija meta jingħata biex ikun immirat livell ta ’ emoglobina ta ’ 12 - 14 g/ dl (7. 5 - 8. 7 mmol/ l),
Abseamed has no influence on the ability to drive and use machines.
Abseamed m’ għandu l- ebda effett fuq il- ħila ta ’ sewqan u l- użu ta ’ magni.
Early shunt revision and thrombosis prophylaxis by administration of acetylsalicylic acid, for example, is recommended in these patients.
Reviżjoni bikrija tax- xant u profilassi tat- trombożi bl- għoti ta ’ acetylsalicylic acid, pereżempju, huwa rakkomandat f’ dawn il- pazjenti.
Abseamed has the highest possible purity according to the present state of the art.
Abseamed għandu l- ogħla purità possibbli skond l- aktar teknoloġija avvanzata fil- preżent.
14 For the purpose of ambulatory use, the patient may remove Abseamed from the refrigerator and store it not above 25°C for one single period of up to 3 days.
Għall- iskop ta ’ użu ambulatorju, il- pazjent jista ’ jneħħi Abseamed minn ġol- friġġ u jaħżnu mhux ’ il fuq minn 25°C għal perijodu wieħed sa 3 ijiem.
Abseamed must not be used
Abseamed m’ għandux jintuża
Medice Arzneimittel Pütter GmbH & Co KG Kuhloweg 37 D-58638 Iserlohn
Medice Arzneimittel Pütter GmbH & Co KG
Treatment with Abseamed has to be initiated under the supervision of physicians experienced in the management of patients with the above indications.
Il- kura b’ Abseamed għandha tinbeda taħt is- superviżjoni ta ’ tobba b’ esperjenza fl- immaniġġar ta ’ pazjenti bis- sintomi msemmija hawn fuq.
18 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 minn 12 g/ dl (7. 5 mmol/ l) għandu jkun evitat; gwida għal aġġustament adattat tad- doża għal meta jkunu osservati fuguri ta ’ l- emoglobina li jaqbżu 12 g/ dl (7. 5 mmol/ l), huma deskritti hawn taħt.
28 For the purpose of ambulatory use, the patient may remove Abseamed from the refrigerator and store it not above 25°C for one single period of up to 3 days.
Għall- iskop ta ’ użu ambulatorju, il- pazjent jista ’ jneħħi Abseamed minn ġol- friġġ u jaħżnu mhux ’ il fuq minn 25°C għal perijodu wieħed sa 3 ijiem.
32 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 minn 12 g/ dl (7. 5 mmol/ l) għandu jkun evitat; gwida għal aġġustament adattat tad- doża għal meta jkunu osservati fuguri ta ’ l- emoglobina li jaqbżu 12 g/ dl (7. 5 mmol/ l), huma deskritti hawn taħt.
42 For the purpose of ambulatory use, the patient may remove Abseamed from the refrigerator and store it not above 25°C for one single period of up to 3 days.
Għall- iskop ta ’ użu ambulatorju, il- pazjent jista ’ jneħħi Abseamed minn ġol- friġġ u jaħżnu mhux ’ il fuq minn 25°C għal perijodu wieħed sa 3 ijiem.
46 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 minn 12 g/ dl (7. 5 mmol/ l) għandu jkun evitat; gwida għal aġġustament adattat tad- doża għal meta jkunu osservati fuguri ta ’ l- emoglobina li jaqbżu 12 g/ dl (7. 5 mmol/ l), huma deskritti hawn taħt.
56 For the purpose of ambulatory use, the patient may remove Abseamed from the refrigerator and store it not above 25°C for one single period of up to 3 days.
Għall- iskop ta ’ użu ambulatorju, il- pazjent jista ’ jneħħi Abseamed minn ġol- friġġ u jaħżnu mhux ’ il fuq minn 25°C għal perijodu wieħed sa 3 ijiem.
60 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 minn 12 g/ dl (7. 5 mmol/ l) għandu jkun evitat; gwida għal aġġustament adattat tad- doża għal meta jkunu osservati fuguri ta ’ l- emoglobina li jaqbżu 12 g/ dl (7. 5 mmol/ l), huma deskritti hawn taħt.
70 For the purpose of ambulatory use, the patient may remove Abseamed from the refrigerator and store it not above 25°C for one single period of up to 3 days.
Għall- iskop ta ’ użu ambulatorju, il- pazjent jista ’ jneħħi Abseamed minn ġol- friġġ u jaħżnu mhux ’ il fuq minn 25°C għal perijodu wieħed sa 3 ijiem.
74 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 minn 12 g/ dl (7. 5 mmol/ l) għandu jkun evitat; gwida għal aġġustament adattat tad- doża għal meta jkunu osservati fuguri ta ’ l- emoglobina li jaqbżu 12 g/ dl (7. 5 mmol/ l), huma deskritti hawn taħt.
84 For the purpose of ambulatory use, the patient may remove Abseamed from the refrigerator and store it not above 25°C for one single period of up to 3 days.
Għall- iskop ta ’ użu ambulatorju, il- pazjent jista ’ jneħħi Abseamed minn ġol- friġġ u jaħżnu mhux ’ il fuq minn 25°C għal perijodu wieħed sa 3 ijiem.
88 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 minn 12 g/ dl (7. 5 mmol/ l) għandu jkun evitat; gwida għal aġġustament adattat tad- doża għal meta jkunu osservati fuguri ta ’ l- emoglobina li jaqbżu 12 g/ dl (7. 5 mmol/ l), huma deskritti hawn taħt.
98 For the purpose of ambulatory use, the patient may remove Abseamed from the refrigerator and store it not above 25°C for one single period of up to 3 days.
Għall- iskop ta ’ użu ambulatorju, il- pazjent jista ’ jneħħi Abseamed minn ġol- friġġ u jaħżnu mhux ’ il fuq minn 25°C għal perijodu wieħed sa 3 ijiem.
102 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 minn 12 g/ dl (7. 5 mmol/ l) għandu jkun evitat; gwida għal aġġustament adattat tad- doża għal meta jkunu osservati fuguri ta ’ l- emoglobina li jaqbżu 12 g/ dl (7. 5 mmol/ l), huma deskritti hawn taħt.
112 For the purpose of ambulatory use, the patient may remove Abseamed from the refrigerator and store it not above 25°C for one single period of up to 3 days.
Għall- iskop ta ’ użu ambulatorju, il- pazjent jista ’ jneħħi Abseamed minn ġol- friġġ u jaħżnu mhux ’ il fuq minn 25°C għal perijodu wieħed sa 3 ijiem.
116 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 minn 12 g/ dl (7. 5 mmol/ l) għandu jkun evitat; gwida għal aġġustament adattat tad- doża għal meta jkunu osservati fuguri ta ’ l- emoglobina li jaqbżu 12 g/ dl (7. 5 mmol/ l), huma deskritti hawn taħt.
126 For the purpose of ambulatory use, the patient may remove Abseamed from the refrigerator and store it not above 25°C for one single period of up to 3 days.
Għall- iskop ta ’ użu ambulatorju, il- pazjent jista ’ jneħħi Abseamed minn ġol- friġġ u jaħżnu mhux ’ il fuq minn 25°C għal perijodu wieħed sa 3 ijiem.
130 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 minn 12 g/ dl (7. 5 mmol/ l) għandu jkun evitat; gwida għal aġġustament adattat tad- doża għal meta jkunu osservati fuguri ta ’ l- emoglobina li jaqbżu 12 g/ dl (7. 5 mmol/ l), huma deskritti hawn taħt.
Dosage adjustment to maintain haemoglobin concentration between 10 g/ dl - 12 g/ dl:
Aġġustament tad- dożaġġ biex iżżomm il- konċentrazzjoni ta ’ l- emoglobina bejn 10 g/ dl – 12g g/ dl:
140 For the purpose of ambulatory use, the patient may remove Abseamed from the refrigerator and store it not above 25°C for one single period of up to 3 days.
Għall- iskop ta ’ użu ambulatorju, il- pazjent jista ’ jneħħi Abseamed minn ġol- friġġ u jaħżnu mhux ’ il fuq minn 25°C għal perijodu wieħed sa 3 ijiem.
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 Abseamed to know the size of any increased immunogenicity risk with subcutaneous 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 Abseamed 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
143 Risk Management plan
Pjan dwar l- Immaniġġjar tar- Riskju
Abseamed 1000 IU/ 0.5 ml solution for injection in a pre-filled syringe
Abseamed 1000 IU/ 0. 5 ml IU soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest
Abseamed 1000 IU/ 0.5 ml
Abseamed 1000 IU/ 0. 5 ml
Abseamed 1000 IU/ 0.5 ml injection
Abseamed 1000 IU/ 0. 5 ml injezzjoni
Abseamed 2000 IU/ 1 ml injection
Abseamed 2000 IU/ 1 ml injezzjoni
Abseamed 3000 IU/ 0.3 ml
Abseamed 3000 IU/ 0. 3 ml
Abseamed 3000 IU/ 0.3 ml injection
Abseamed 3000 IU/ 0. 3 ml injezzjoni
EXPIRY DATE
DATA META JISKADI
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
IL- KONTENUT SKOND IL- PIŻ, VOLUM, JEW PARTI INDIVIDWALI
OTHER
OĦRAJN
158 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
168 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
OUTER CARTON
KARTUNA TA ’ BARRA
Abseamed 4000 IU/ 0.4 ml solution for injection in a pre-filled syringe
Abseamed 4000 IU/ 0. 4 ml soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest
1 pre-filled syringe of 0.4 ml contains 4000 international units (IU) corresponding to 33.6 micrograms epoetin alfa
Siringa mimlija għal- lest ta ’ 0. 4 ml fiha 4000 unità internazzjonali (IU) li jikkorrispondu għal 33. 6 mikrogrammi ta ’ epoetin alfa
Excipients: sodium dihydrogen phosphate dihydrate, disodium phosphate dihydrate, sodium chloride, glycine, polysorbate 80, hydrochloric acid (for pH-adjustment), sodium hydroxide (for pH-adjustment), and water for injections
Sustanzi mhux attivi: sodium dihydrogen phosphate dihydrate, disodium phosphate dihydrate, sodium chloride, glycine, polysorbate 80, hydrochloric acid (għal aġġustament tal- pH), sodium hydroxide (għal aġġustament tal- pH), u ilma għall- injezzjonijiet
Solution for injection in a pre-filled syringe.
Soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest.
1 pre-filled syringe of 0.4 ml 6 pre-filled syringes of 0.4 ml
Siringa 1 mimlija għal- lest ta ’ 0. 4 ml 6 siringi mimlija għal- lest ta ’ 0. 4 ml
METHOD AND ROUTE(S) OF ADMINISTRATION
MOD TA ’ KIF U MNEJN JINGĦATA
For subcutaneous and intravenous use.
Użu għal taħt il- ġilda u għal ġol- vini.
Do not shake.
Tħawwadx.
Keep out of the reach and sight of children.
Żommu fejn ma jintlaħaqx u ma jidhirx mit- tfal.
EXP
JIS
Store and transport refrigerated (2°C - 8°C).
Żommu fi friġġ waqt il- ħażna u l- ġarr (2°C - 8°C).
Keep the pre-filled syringe in the outer carton in order to protect from light.
Żomm is- siringa mimlija għal- lest fil- kartuna ta ’ barra biex tilqa ’ mid- dawl.
Medice Arzneimittel Pütter GmbH & Co KG, Kuhloweg 37, D-58638 Iserlohn, Germany
Medice Arzneimittel Pütter GmbH & Co KG, Kuhloweg 37, D- 58638 Iserlohn, il- Ġermanja
MARKETING AUTHORISATION NUMBER(S)
NUMRU( I) TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
Batch
Lott
Abseamed 4000 IU/ 0.4 ml
Abseamed 4000 IU/ 0. 4 ml
160 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
170 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
BLISTER
FOLJA
NAME OF THE MARKETING AUTHORISATION HOLDER
ISEM TAD- DETENTUR TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
161 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
171 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
LABEL/ SYRINGE
TIKKETTA/ SIRINGA
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION
ISEM TAL- PRODOTT MEDIĊINALI U MNEJN GĦANDU JINGĦATA
Abseamed 4000 IU/ 0.4 ml injection
Abseamed 4000 IU/ 0. 4 ml injezzjoni
162 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
172 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Abseamed 5000 IU/ 0.5 ml solution for injection in a pre-filled syringe
Abseamed 5000 IU/ 0. 5 ml soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest
1 pre-filled syringe of 0.5 ml contains 5000 international units (IU) corresponding to 42.0 micrograms epoetin alfa
Siringa mimlija għal- lest ta ’ 0. 5 ml fiha 5000 unità internazzjonali (IU) li jikkorrispondu għal 42. 0 mikrogrammi ta ’ epoetin alfa
1 pre-filled syringe of 0.5 ml 6 pre-filled syringes of 0.5 ml
Siringa 1 mimlija għal- lest ta ’ 0. 5 ml 6 siringi mimlija għal- lest ta ’ 0. 5 ml
Abseamed 5000 IU/ 0.5 ml
Abseamed 5000 IU/ 0. 5 ml
164 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
174 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
165 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
175 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Abseamed 5000 IU/ 0.5 ml injection
Abseamed 5000 IU/ 0. 5 ml injezzjoni
166 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
176 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Abseamed 6000 IU/ 0.6 ml solution for injection in a pre-filled syringe
Abseamed 6000 IU/ 0. 6 ml soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest
1 pre-filled syringe of 0.6 ml contains 6000 international units (IU) corresponding to 50.4 micrograms epoetin alfa
Siringa mimlija għal- lest ta ’ 0. 6 ml fiha 6000 unità internazzjonali (IU) li jikkorrispondu għal 50. 4 mikrogrammi ta ’ epoetin alfa
1 pre-filled syringe of 0.6 ml 6 pre-filled syringes of 0.6 ml
Siringa 1 mimlija għal- lest ta ’ 0. 6 ml 6 siringi mimlija għal- lest ta ’ 0. 6 ml
Abseamed 6000 IU/ 0.6 ml
Abseamed 6000 IU/ 0. 6 ml
168 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
178 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
169 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
179 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Abseamed 6000 IU/ 0.6 ml injection
Abseamed 6000 IU/ 0. 6 ml injezzjoni
170 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
180 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Abseamed 7000 IU/ 0.7 ml solution for injection in a pre-filled syringe
Abseamed 7000 IU/ 0. 7 ml soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest
1 pre-filled syringe of 0.7 ml contains 7000 international units (IU) corresponding to 58.8 micrograms epoetin alfa
Siringa mimlija għal- lest ta ’ 0. 7 ml fiha 7000 unità internazzjonali (IU) li jikkorrispondu għal 58. 8 mikrogrammi ta ’ epoetin alfa
1 pre-filled syringe of 0.7 ml 6 pre-filled syringes of 0.7 ml
Siringa 1 mimlija għal- lest ta ’ 0. 7 ml 6 siringi mimlija għal- lest ta ’ 0. 7 ml
Abseamed 7000 IU/ 0.7 ml
Abseamed 7000 IU/ 0. 7 ml
172 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
182 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
173 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
183 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Abseamed 7000 IU/ 0.7 ml injection
Abseamed 7000 IU/ 0. 7 ml injezzjoni
174 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
184 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Abseamed 8000 IU/ 0.8 ml solution for injection in a pre-filled syringe
Abseamed 8000 IU/ 0. 8 ml soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest
1 pre-filled syringe of 0.8 ml contains 8000 international units (IU) corresponding to 67.2 micrograms epoetin alfa
Siringa mimlija għal- lest ta ’ 0. 8 ml fiha 8000 unità internazzjonali (IU) li jikkorrispondu għal 67. 2 mikrogrammi ta ’ epoetin alfa
1 pre-filled syringe of 0.8 ml 6 pre-filled syringes of 0.8 ml
Siringa 1 mimlija għal- lest ta ’ 0. 8 ml 6 siringi mimlija għal- lest ta ’ 0. 8 ml
Abseamed 8000 IU/ 0.8 ml
Abseamed 8000 IU/ 0. 8 ml
176 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
186 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
177 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
187 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Abseamed 8000 IU/ 0.8 ml injection
Abseamed 8000 IU/ 0. 8 ml injezzjoni
178 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
188 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Abseamed 9000 IU/ 0.9 ml solution for injection in a pre-filled syringe
Abseamed 9000 IU/ 0. 9 ml soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest
1 pre-filled syringe of 0.9 ml contains 9000 international units (IU) corresponding to 75.6 micrograms epoetin alfa
Siringa mimlija għal- lest ta ’ 0. 9 ml fiha 9000 unità internazzjonali (IU) li jikkorrispondu għal 75. 6 mikrogrammi ta ’ epoetin alfa
1 pre-filled syringe of 0.9 ml 6 pre-filled syringes of 0.9 ml
Siringa 1 mimlija għal- lest ta ’ 0. 9 ml 6 siringi mimlija għal- lest ta ’ 0. 9 ml
Abseamed 9000 IU/ 0.9 ml
Abseamed 9000 IU/ 0. 9 ml
180 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
190 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
181 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
191 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Abseamed 9000 IU/ 0.9 ml injection
Abseamed 9000 IU/ 0. 9 ml injezzjoni
182 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
192 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Abseamed 10 000 IU/ 1 ml solution for injection in a pre-filled syringe
Abseamed 10, 000 IU/ 1 ml soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest
1 pre-filled syringe of 1 ml contains 10 000 international units (IU) corresponding to 84.0 micrograms epoetin alfa
Siringa mimlija għal- lest ta ’ 1 ml fiha 10, 000 unità internazzjonali (IU) li jikkorrispondu għal 84. 0 mikrogrammi ta ’ epoetin alfa
1 pre-filled syringe of 1 ml 6 pre-filled syringes of 1 ml
Siringa 1 mimlija għal- lest ta ’ 1 ml 6 siringi mimlija għal- lest ta ’ 1 ml
Abseamed 10 000 IU/ 1 ml
Abseamed 10, 000 IU/ 1 ml
184 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
194 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
185 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
195 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Abseamed 10 000 IU/ 1 ml injection
Abseamed 10, 000 IU/ 1 ml injezzjoni
PACKAGE LEAFLET
FULJETT TA ’ TAGĦRIF
187 PACKAGE LEAFLET:
197 FULJETT TA ’ TAGĦRIF:
INFORMATION FOR THE USER
INFORMAZZJONI GĦAL MIN QED JAGĦMEL UŻU MINNU
Abseamed 1000 IU/ 0.5 ml solution for injection in a pre-filled syringe
Abseamed 1000 IU/ 0. 5 ml soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest
Abseamed 2000 IU/ 1 ml solution for injection in a pre-filled syringe
Abseamed 2000 IU/ 1 ml soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest
Abseamed 3000 IU/ 0.3 ml solution for injection in a pre-filled syringe
Abseamed 3000 IU/ 0. 3 ml soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest
Abseamed 10 000 IU/ 1 ml solution for injection in a pre-filled syringe Epoetin alfa
Abseamed 10, 000 IU/ 1 ml soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest Epoetin alfa
Read all of this leaflet carefully before you start using this medicine.
Aqra sew dan il- fuljett kollu qabel tibda tuża din il- mediċina.
You may need to read it again.
Jista jkollok bżonn terġa ’ taqrah.
Do not pass it on to others.
Tista ’ tagħmlilhom
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
- Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li m’ humiex
What Abseamed is and what it is used for 2.
X’ inhu Abseamed u għalxiex jintuża 2.
Before you use Abseamed 3.
Qabel ma tuża Abseamed 3.
How to use Abseamed 4.
Kif għandek tuża Abseamed 4.
How to store Abseamed 6.
Kif taħżen Abseamed 6.
WHAT ABSEAMED IS AND WHAT IT IS USED FOR
X’ INHU ABSEAMED U GĦALXIEX JINTUŻA
Abseamed contains a hormone called epoetin alfa, which stimulates the production of red blood cells.
Abseamed fih ormon imsejjaħ epoetin alfa, li jistimula l- produzzjoni taċ- ċelluli l- ħomor tad- demm.
Epoetin alfa is produced by a specialised genetic technology and works in exactly the same way as the natural hormone erythropoietin.
Epoetin alfa huwa prodott b’ teknoloġija ġenetika speċjalizzata u jaħdem eżatt bl- istess mod bħal l - ormon naturali eritropoetin.
Abseamed is used: for treating symptomatic anaemia associated with kidney disease (given by injection into a vein) in children and adults on dialysis in adults on peritoneal dialysis for treating severe symptomatic anaemia caused by kidney disease in adults not yet undergoing dialysis (given by injection into a vein) for treating anaemia and reducing the need for a blood transfusion in adults receiving chemotherapy for solid tumours, malignant lymphoma or multiple myeloma, and at risk of transfusion as assessed by the doctor in moderately anaemic patients who are going to have surgery and prior to it, donate blood so that their own blood can be given to them during or after surgery (autologous predonation) as an alternative to a blood transfusion in adult patients about to undergo major orthopaedic (bone) surgery where there is a potentially high risk from blood transfusion complications
Abseamed jintuża: biex tiġi kkurata anemija sintomatika assoċjata ma ’ mard tal- kliewi (mogħti permezz ta ’ injezzjoni ġo vina) fi tfal u adulti fuq id- dijalisi f’ adulti fuq dijalisi peritonali biex tiġi kkurata anemija sintomatika severa kkawżata minn mard tal- kliewi f’ persuni adulti li jkunu għadhom mhux qegħdin fuq id- dijalisi (mogħti permezz ta ’ injezzjoni ġo vina) biex tiġi kkurata anemija u titnaqqas il- ħtieġa għal trasfużjoni tad- demm f’ persuni adulti li jkunu qegħdin jirċievu kimoterapija għal tumuri solidi, limfoma malinna jew majeloma multipla, u f’ riskju ta ’ trasfużjoni kif evalwat mit- tabib f’ pazjenti li jkunu moderatament anemiċi li jkun ser ikollhom operazzjoni, u qabel din issir, jagħtu d - demm biex id- demm tagħhom stess ikun jista ’ jingħatalhom waqt jew wara l- operazzjoni (predonazzjoni awtologa)
BEFORE YOU USE ABSEAMED
QABEL MA TUŻA ABSEAMED
Do not use Abseamed:
Tużax Abseamed:
- if you are allergic (hypersensitive) to epoetin alfa or any of the other ingredients of Abseamed
- jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal epoetin alfa jew sustanzi oħra ta ’
- if you have developed Pure Red Cell Aplasia (reduced or stopped production of red blood cells)
- jekk żviluppajt Aplasja taċ- Ċelluli l- Ħomor tad- Demm Pura (tnaqqis jew waqfien tal -
following treatment with any erythropoietin
produzzjoni taċ- ċelluli l- ħomor tad- demm) wara kura b’ xi eritropoetin
- if you have high blood pressure which is not properly controlled
- jekk għandek pressjoni għolja tad- demm li mhix ikkontrollata tajjeb
- if you are donating your own blood before surgery, and:
- jekk qed tagħti d- demm tiegħek stess qabel l- operazzjoni, u:
• you had a heart attack or stroke in the month before your treatment • you have unstable angina pectoris (new or increasing chest pain) • you are at risk of blood clots in the veins (deep venous thrombosis) – for example, if you have had clots before
• kellek attakk tal- qalb jew puplesija fix- xahar ta ’ qabel il- kura tiegħek • għandek anġina pectoris instabbli (uġigħ fis- sider li tħossu għall- ewwel darba jew li jiżdied) • għandek riskju ta ’ emboli tad- demm fil- vini (trombożi venuża profonda) – per eżempju, jekk kellek l- emboli fil- passat
- if you cannot receive adequate treatment for the prevention of blood clots (antithrombotic
- jekk ma tistax tirċievi kura adegwata għall- prevenzjoni ta ’ tagħqid tad- demm (profilassi
prophylaxis)
antitrombotika)
- if you are due to have major orthopaedic surgery and:
- jekk tkun ser tagħmel operazzjoni ortopedika maġġuri u:
you have severe disorders of blood circulation of the heart (coronary heart disease), arteries of the legs or arms (peripheral arterial occlusive disease), neck vessels (vascular disease of the carotids) or the brain (cerebrovascular disease) you had a recent heart attack or stroke
għandek disturbi severi fiċ- ċirkolazzjoni tad- demm tal- qalb (mard tal- qalb koronarju), l- arterji tar- riġlejn u tad- dirgħajn (mard okklużiv ta ’ l- arterji periferali), l- arterji u l- vini ta ’ l - għonq (mard vaskulari tal- karotidi) jew il- moħħ (mard ċerebrovaskulari) Jekk sofrejt attakk tal- qalb jew puplesija riċenti
If any of these applies to you, or might apply, tell your doctor at once.
Jekk xi waħda minn dawn tapplika għalik, jew tista ’ tapplika, għid lit- tabib tiegħek minnufih.
Take special care with Abseamed:
Oqgħod attent ħafna b’ Abseamed:
In all patients treated with Abseamed blood pressure should be closely monitored and treated, if necessary.
Il- pressjoni tad- demm fil- pazjenti kollha kkurati b’ Abseamed għandha tiġi mmonitorjata mill- qrib u kkurata, jekk ikun meħtieġ.
Abseamed should be used with caution in the presence of untreated, inadequately treated or poorly controllable hypertension.
Abseamed għandu jintuża b’ attenzjoni fil- preżenza ta ’ pressjoni għolja mhux ikkurata, ikkurata b’ mod inadegwat jew li ma tistax tiġi kkontrollata tajjeb.
It may be necessary to initiate or increase treatment against high blood pressure.
Jista ’ jkun meħtieġ li tibda jew iżżid il- kura kontra l- pressjoni għolja tad- demm.
If blood pressure cannot be controlled, Abseamed treatment should be discontinued.
Jekk il- pressjoni tad- demm ma tkunx tista ’ tiġi kkontrollata, il- kura b’ Abseamed għandha titwaqqaf.
Take special care with Abseamed if you have epilepsy or chronic liver disease.
Oqgħod attent ħafna b’ Abseamed jekk għandek epilessija jew mard kroniku tal- fwied.
There may be a moderate dose-dependent increase in the platelet count within the normal range during treatment with Abseamed, which gradually regresses during the course of continued therapy.
Jista ’ jkun hemm żieda moderata dipendenti fuq id- doża fl- għadd ta ’ plejtlits fil- medda normali waqt kura b’ Abseamed, li gradwalment tmur lura matul il- kors tat- terapija kontinwa.
Your doctor may do regular blood tests to check your blood platelet count during the first 8 weeks of therapy.
It- tabib tiegħek jista ’ jagħmillek testijiet regolari tad- demm biex jiċċekkja l- għadd tal- plejtlits fid- demm tiegħek matul l - ewwel 8 ġimgħat tat- terapija.
All other causes of anaemia, e. g. iron deficiency, damage of red blood cells (haemolysis), blood loss, vitamin B12 or folate deficiency, should be taken into account and treated prior to initiating therapy with Abseamed.
Il- kawżi l- oħra kollha ta ’ anemija, eż. defiċjenza ta ’ ħadid, ħsara fiċ- ċelluli l- ħomor tad- demm (emodijalisi), telf ta ’ demm, defiċjenza ta ’ vitamina B12 jew ta ’ folate, għandhom jiġu kkunsidrati u kkurati qabel tinbeda t- terapija b’ Abseamed.
In order to ensure optimum response to Abseamed adequate iron stores should be ensured.
Sabiex jiġi assigurat l- aħjar respons għal Abseamed għandhom ikunu żgurati ħażniet adegwati ta ’ ħadid.
Your doctor may do blood tests to decide, if you need iron supplements.
It- tabib tiegħek jista ’ jagħmillek testijiet tad - demm biex jiddeċiedi jekk għandekx bżonn supplimenti ta ’ ferritin.