qanastek/EMEA-V3 huggingface dataset:
The effectiveness was the same if it was administered intravenously or subcutaneously.
L- effettività kienet l- istess kemm jekk ingħata ġol- vina kif ukoll taħt il- ġilda.
What is the risk associated with Dynepo?
X’ inhu r- riskju assoċjat ma ’ Dynepo?
The most common side effects are hypertension (raised blood pressure), headache, and, for patients on dialysis, problems with the dialysis tubes.
L- aktar effetti sekondarji komuni huma pressjoni għolja, uġigħ ta ’ ras, u, għal pazjenti fuq dijaliżi, problemi bit- tubi tad- dijaliżi.
For the full description of the side effects reported with Dynepo, please see the Package Leaflet.
Għal deskrizzjoni sħiħa ta ’ l- effetti sekondarji kollha rrapportati b’ Dynepo, jekk jogħġbok ara l- Fuljett ta ’ Tagħrif mehmuż mal- pakkett.
Dynepo should not be used in people who may be hypersensitive (allergic) to epoetin delta or any of the other ingredients, and in patients who have uncontrolled high blood pressure.
Dynepo m’ għandux jintuża f’ nies li jistgħu jkunu sensittivi żżejjed (allerġiċi) għal epoetin delta jew
Allergic reactions have occasionally been seen, so it is recommended that the first dose of Dynepo be given under medical supervision.
Xi kultant dehru reazzjonijiet allerġiċi, għalhekk huwa rrakkomandat li l- ewwel doża ta ’ Dynepo tingħata taħt sorveljanza medika.
ed Why has Dynepo been approved?
riz Għalxiex ġie approvat Dynepo?
They
to Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ Dynepo għat- trattament ta ’ anemija f’ pazjenti bi problemi kroniċi fil- kliewi huma akbar mir- riskji
or recommended that Dynepo be given marketing authorisation.
Huma rrakkomandaw li Dynepo jingħata l- awtorizzazzjoni għat- tqegħid fis- suq.
th Other information about Dynepo:
Tagħrif ieħor dwar Dynepo:
au for Dynepo to Shire Pharmaceutical Contracts Ltd on 18 March 2002.
x Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- Unjoni Ewropea kollha, għal Dynepo lil Shire Pharmaceutical Contracts Ltd nhar it- 18 ta ’ Marzu 2000.
The marketing authorisation was renewed on 18 March 2007.
L -
er The full EPAR for Dynepo is available here. ng lo This summary was last updated in 03-2007. no ct du ro ed M
du awtorizzazzjoni għat- tqegħid fis- suq ġiet imġedda fit- 18 ta ’ Marzu 2007. ħa L- EPAR sħiħ għal Dynepo jista ’ jinkiseb minn hawn. ’ g
ic
Dan is- sommarju ġie aġġornat l- aħħar f’ 03- 2007. im il al in iċ ed m t ot od Pr
is ed r EU Number
at zz
Invented
Għamla
Strength
Kontenut
Pharmaceutical
ri Numru ta ’ l- EU
Route of
Isem
Packaging
Qawwa
Content
farmaċewtika
Package Size
Mnejn jingħata
Name
Il- pakkett
Form
(konċentrazzjoni)
Administration
Daqs tal- pakkett
th EU/ 1/ 02/ 211/ 001
to Siringa mimlija EU/ 1/ 02/ 211/ 001
1,000 IU
1, 000 IU
Subcutaneous or
Soluzzjoni għall -
Pre-filled syringe
għal- lest (ħġieġ)
0.5ml
0. 5ml
6 pre-filled
6 siringi mimlija
intravenous use
injezzjoni
(glass)
jew taħt il- ġilda
(2,000 IU/ 1.0ml)
(2, 000 IU/ 1. 0ml)
syringes
għal- lest
EU/ 1/ 02/ 211/ 002
w a Siringa mimlija EU/ 1/ 02/ 211/ 002
2,000 IU
2, 000 IU
Solution for injection
Soluzzjoni għall -
Subcutaneous or intravenous use
Użu għal ġol- vini
r a Pre-filled syringe (glass)
għal- lest (ħġieġ)
6 pre-filled syringes
6 siringi mimlija
e (4,000 IU/ 1.0ml)
(4, 000 IU/ 1. 0ml)
3,000 IU
3, 000 IU
Pre-filled syringe
Użu għal ġol- vini
0.3ml
0. 3ml
injection
d għal- lest (ħġieġ)
(10,000 IU/ 1.0ml)
(10, 000 IU/ 1. 0ml)
lo EU/ 1/ 02/ 211/ 004
ħa Siringa mimlija EU/ 1/ 02/ 211/ 004
4,000 IU
4, 000 IU
0.4ml
0. 4ml
o
’ g
injection
injezzjoni
intravenous use
jew taħt il- ġilda
(glass)
Siringa mimlija
EU/ 1/ 02/ 211/ 005
EU/ 1/ 02/ 211/ 010
10,000 IU
5, 000 IU
injection
im 0. 5ml għal- lest (ħġieġ)
(20,000 IU/ 1.0ml)
(10, 000 IU/ 1. 0ml)
u EU/ 1/ 02/ 211/ 010
il Siringa mimlija EU/ 1/ 02/ 211/ 011
5,000 IU
6, 000 IU
Solution for
Soluzzjoni
Subcutaneous or
għall -
od
l
injection
għal- lest (ħġieġ)
(10,000 IU/ 1.0ml)
a (20, 000 IU/ 1. 0ml)
r EU/ 1/ 02/ 211/ 011
in Siringa mimlija EU/ 1/ 02/ 211/ 012
6,000 IU
8, 000 IU
0.3ml
0. 4ml
injection
iċ għal- lest (ħġieġ)
l (20,000 IU/ 1.0ml)
(20, 000 IU/ 1. 0ml)
a EU/ 1/ 02/ 211/ 012
d Siringa mimlija EU/ 1/ 02/ 211/ 005
8,000 IU
10, 000 IU
0.4ml
0. 5ml
(20,000 IU/ 1.0ml)
(20, 000 IU/ 1. 0ml)
d ic M e 1/ 1
m tt o od r P 1/ 1
ed is or th au er ANNEX Ing SUMMARY OF PRODUCT CHARACTERISTICS lo no ct du ro lp a in ic ed M
t za riz to aw x du ANNESS I ħa SOMMARJU TAL- KARATTERISTIĊI TAL- PRODOTT ’ g im il al in iċ ed m t ot od Pr
Dynepo 1,000 IU/ 0.5 ml solution for injection in a pre-filled syringe.
Dynepo 1, 000 IU/ 0. 5 ml soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest.
Pre-filled syringe containing 1,000 IU per 0.5 ml dose (2,000 IU/ ml) of the active substance epoetin delta.
Siringa mimlija għal- lest li fiha 1, 000 IU f’ kull doża ta ’ 0. 5 ml (2, 000 IU/ ml) tas- sustanza attiva epoetin delta.
Epoetin delta is produced in human cells (HT-1080) by gene-activation technology.
Epoetin delta hu prodott fiċ- ċelluli tal- bniedem (HT- 1080) bit- teknoloġija ta ’ l- attivazzjoni tal- ġeni.
For a full list of excipients, see section 6.1.
t za Għal- lista kompleta ta ’ sustanzi mhux attivi, ara sezzjoni 6. 1.
Solution for injection in a pre-filled syringe.
to Soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest.
is Clear, colourless and waterlike.
Soluzzjoni ċara, bla kulur u qisha ilma.
or th 4.
aw 4.
au 4.1 Therapeutic indications
x du 4. 1 Indikazzjonijiet terapewtiċi
er Dynepo is indicated for the treatment of symptomatic anaemia associated with chronic renal failure (CRF) in adult patients.
Dynepo hu indikat għall- kura ta ’ anemija sintomatika assoċjata ma ’ insuffiċjenza renali kronika (CRF) ħa f’ pazjenti adulti.
It may be used in patients on dialysis and in patients not on dialysis. ng 4.2 Posology and method of administration lo
Jista ’ jintuża kemm f’ pazjenti li huma fuq id- dijaliżi kif ukoll f’ pazjenti li mhumiex fuq id- dijaliżi. ’ g
Treatment with Dynepo should be initiated by physicians experienced in the treatment of anaemia no
4. 2 Pożoloġija u metodu ta ’ kif għandu jingħata im
associated with CRF..
Il- kura b’ Dynepo għandha tinbeda minn tobba li għandhom esperjenza fil- kura ta ’ anemija assoċjata ma ’ CRF. il
The dosage of Dynepo must be adjusted individually to maintain the level of haemoglobin within the ct
Id- dożaġġ ta ’ Dynepo jrid ikun aġġustat individwalment biex iżomm il- livell ta ’ l- emoglobina fil - al
target range of 10 to 12g/ dl. du
medda tal- mira ta ’ 10 sa 12g/ dl. in
Dynepo ro
Sintomi ta ’ anemija u kundizzjonijiet jew mard b’ konsegwenza tagħha jistgħu jvarjaw ma ’ l- età, sess, iċ
should be administered either subcutaneously or intravenously in order to increase haemoglobin to not greater than 12 g/ dL (7.5 mmol/ L).
u l- gravità totali tal- marda; hemm bżonn ta ’ evalwazzjoni ta ’ tabib tal- kors kliniku u tal- kundizzjoni tal- pazjent individwali.
Subcutaneous use is preferable in patients who are not receiving lp
Dynepo għandu jingħata minn taħt il- ġilda jew ġol- vina biex iżid l- emoglobina ed
haemodialysis to avoid puncture of peripheral veins. a
għal mhux iktar minn 12 g/ dL (7. 5 mmol/ l).
Due to intra-patient variability, occasional individual haemoglobin values for a patient above and in
L- użu taħt il- ġilda hu preferibbli f’ pazjenti li mhux qed jirċievu l- emodijalisi biex jevitaw li jtaqqbu vini periferali m
below the desired haemoglobin level may be observed.
Minħabba l- varjabilità bejn il- pazjenti, okkażjonalment jistgħu jkunu osservati valuri ‘ il fuq u ‘ l isfel mil- livell mixtieq ta ’ l- emoglobina għal pazjent.
Haemoglobin variability should be addressed through dose management, with consideration for the haemoglobin target range of 10 g/ dL ic
Il- varjabilità ta ’ l- emoglobina għandha tkun t ot
(6.2 mmol/ l) to 12g/ dL (7.5mmol/ l).
indirizzata permezz ta ’ l- immaniġġjar tad- doża, b’ konsiderazzjoni għall- medda tal- mira ta ’ l - emoglobina ta ’ 10 g/ dL (6. 2 mmol/ l) sa 12 g/ dL (7. 5 mmol/ l).
A sustained haemoglobin level of greater than 12 g/ dL ed
Livell sostnut ta ’ emoglobina ta ’ iktar od
(7.5 mmol/ l) should be avoided; guidance for appropriate dose adjustment for when haemoglobin values exceeding 12 g/ dL (7.5mmol/ l) are observed, are described below (see Dose Management M
Pr
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 adjustment should be made as provided.
Jekk din isseħħ, għandu jsir aġġustament adattat fid- doża kif provdut.
Patients should be monitored closely to ensure that the lowest approved dose of Dynepo 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 ’ Dynepo biex tipprovdi kontroll adegwat tas- sintomi ta ’ l- anemija.
2 Dose Management
Immaniġġjar tad- Doża
Starting dose is 50 IU/ kg three times a week if administered intravenously.
2 Id- doża tal- bidu hi ta ’ 50 IU/ kg tliet darbiet f’ ġimgħa jekk tingħata ġol- vina.
50 IU/ kg twice a week if administered subcutaneously.
50 IU/ kg darbtejn f’ ġimgħa jekk tingħata taħt il- ġilda.
It may not be necessary to use erythropoietin during the first three months after starting peritoneal dialysis because an increase in haemoglobin often occurs during this period.
Jista ’ ma jkunx meħtieġ li tuża erythropoetin matul l- ewwel tliet xhur wara li tibda d- dijaliżi peritoneali minħabba li żieda fl- emoglobina ta ’ spiss isseħħ matul dan il- perjodu.
Sufficient time should be allowed to determine a patient ’ s responsiveness to a dosage of Dynepo before adjusting the dose.
Għandu jkun hemm żmien biżżejjed biex jiġi stabbilit ir- rispons tal- pazjent għal dożaġġ ta ’ Dynepo qabel taġġusta d- doża.
Because of the time required for erythropoiesis, an interval of approximately 4 weeks may occur between the time of a dose adjustment (initiation, increase, decrease or discontinuation) and a significant change in haemoglobin.
Minħabba ż- żmien meħtieġ għal erythropoiesis, intervall ta ’ madwar 4 ġimgħat jista ’ jgħaddi bejn meta jsir aġġustament tad- doża (il- bidu, iż- żieda, it- tnaqqis jew it- twaqqif) u tibdil sinifikanti fl- emoglobina.
In consequence, dose adjustment should not
Bħala konsegwenza, l- aġġustament tad- doża m’ għandux isir iktar minn
ed be made more frequently than once a month, unless clinically indicated.
t za darba f’ xahar, ħlief jekk klinikament indikat.
Dose should be decreased by 25% – 50% or treatment temporarily withdrawn and then re-introduced
Id- doża għandha titnaqqas b’ 25% – 50% jew il- kura titwaqqaf temporanjament u mbagħad tinbeda
is with a lower dosage if:
riz mill- ġdid b’ dożaġġ iktar baxx jekk:
- Haemoglobin reaches ≥ 12 g/ dl or
- L- emoglobina tilħaq ≥ 12 g/ dl jew
- The rate of increase of haemoglobin > 2 g/ dl in any 4 week period.
- Ir- rata taż- żieda ta ’ l- emoglobina tkun ta ’ > 2 g/ dl fi kwalunkwe perjodu ta ’ 4 ġimgħat.
th Dose should be increased by 25% – 50% if:
aw Id- doża għandha tiżdied b’ 25% – 50% jekk:
- Haemoglobin falls below < 10 g/ dl and
- L- emoglobina taqa ’ < 10 g/ dl u
- The rate of increase of haemoglobin is below 0.7 g/ dl in any 4 week period.
- Ir- rata taż- żieda ta ’ emoglobina tkun inqas minn 0. 7 g/ dl fi kwalunkwe perjodu ta ’ 4 ġimgħat.
er Administration ng Dynepo may be administered intravenously or subcutaneously.
du Dynepo jista ’ jingħata ġol- vina jew taħt il- ġilda.
Subcutaneous self administration may be used after training by a medical professional. lo
L- għoti ta ’ injezzjoni taħt il- ġilda mill- pazjent stess, jista ’ jsir wara taħriġ minn persuna medika professjonali. ħa Id- doża meħtieġa ta ’ kull ġimgħa ta ’ Dynepo hi iktar baxxa meta Dynepo jingħata taħt il- ġilda meta mqabbel ma ’ l- għoti ġol- vina. ’ g im
The required weekly dose of Dynepo is lower when Dynepo is administered subcutaneously compared no
Għall- injezzjoni taħt il- ġilda, it- tul kollu tal- labra għandu jiddaħħal b’ mod perpendikulari f’ parti tal - ġilda li tinżamm bejn is- saba ’ l- kbir u s- saba ’ l- werrej.
to intravenously. ct
Din il- parti tal- ġilda għandha tinżamm waqt l - għoti kollu ta ’ l- injezzjoni. il
Discard the syringe after initial single use. ro
Armi s- siringa wara użu wieħed inizjali. al
Special populations lp
Popolazzjonijiet speċjali in
Dynepo is not indicated for the management of anaemia associated with cancer. a in
Dynepo mhuwiex indikat għall- immaniġġjar ta ’ anemija marbuta mal- kanċer. iċ
Patients with homozygous sickle cell disease and renal failure should where possible be maintained at ic
L- ebda aġġustamenti speċjali fid- dożaġġ m’ huma meħtieġa f’ pazjenti anzjani. ed
a total haemoglobin concentration between 7 and 9 g/ dl. ed
Pazjenti li għandhom il- homozygous sickle cell disease u kollass tal- kliewi għandhom, fejn ikun possibbli, jinżammu f’ konċentrazzjoni totali ta ’ l- emoglobina bejn 7 u 9 g/ dl. m
The experience in children is limited.
L- esperjenza fit- tfal hi limitata.
Due to limited experience, the efficacy and safety of Dynepo could not be assessed in patients with M
Minħabba esperjenza limitata, l- effikaċja u s- sigurtà ta ’ Dynepo ma jistgħux ikunu evalwati f’ pazjenti b’ indeboliment fil- funzjoni tal- fwied. t ot
4.3 Contra-indications
4. 3 Kontra- indikazzjonijiet od
Hypersensitivity to the active substance or to any of the excipients Uncontrolled hypertension.
Pr
In patients with chronic renal failure, maintenance haemoglobin concentration should not exceed the upper limit of the target haemoglobin concentration recommended in Section 4.2.
F’ pazjenti b’ insuffiċjenza kronika renali, il- konċentrazzjoni tal- manteniment ta ’ l- emoglobina m’ għandhiex taqbeż il- limitu ta ’ fuq tal- konċentrazzjoni ta ’ l- emoglobina fil- mira rakkomandata f’ sezzjoni 4. 2.
3 In clinical trials, an increased risk of death and serious cardiovascular events was observed when erythropoiesis stimulating agents (ESAs) were administered to target a haemoglobin of greater than 12 g/ dL (7.5 mmol/ l).
Fi provi kliniċi, kienet osservata żieda fir- riskju ta ’ mewt u avvenimenti kardjovaskulari serji meta ngħataw mediċini li jistimulaw l- erythropoiesis (ESAs) biex jinkiseb livell ta ’ emoglobina ta ’ iktar
Controlled clinical trials have not shown significant benefits attributable to the administration of epoetins when haemoglobin concentration is increased beyond the level necessary to control symptoms of anaemia and to avoid blood transfusion.
Provi kliniċi kkontrollati ma wrewx benefiċċji sinifikanti attribwibbli għall- għoti ta ’ epoetins meta l - konċentrazzjoni ta ’ l- emoglobina tiżdied lilhemm mil- livell meħtieġ biex tikkontrolla s- sintomi ta ’ l - anemija u biex tevita trasfużjoni tad- demm.
Hypertension
Pressjoni għolja Il- biċċa l- kbira tal- pazjenti b’ kollass kroniku tal- kliewi għandhom storja medika ta ’ pressjoni għolja tad- demm.
Most of patients with chronic renal failure have a history of hypertension.
Pazjenti li jkunu fuq it- terapija Dynepo jista ’ jkollhom żieda fil- pressjoni tad- demm jew l -
Patients on Dynepo therapy can experience increase in blood pressure or aggravation of existing hypertension.
t aggravament ta ’ pressjoni tad- demm diġa ’ eżistenti.
ed Therefore, in patients treated with Dynepo, special care should be taken to monitor closely and control blood pressure.
za Għalhekk, għandha tingħata attenzjoni speċjali lil pazjenti li jkunu kkurati b’ Dynepo, biex isir monitoraġġ mill- qrib u kontroll tal- pressjoni tad- demm.
Blood pressure should be controlled adequately before initiation and during therapy to
Il- pressjoni tad- demm għandha tiġi
is avoid acute complications like hypertensive encephalopathy and related complications (seizures, stroke).
riz kkontrollata b’ mod adegwat qabel il- bidu u matul it- terapija biex jiġu evitati komplikazzjonijiet akuti bħal enċefalopatija ipertensiva u komplikazzjonijiet relatati magħha (attakki ta ’ puplesija).
If these reactions occur they require the immediate attention of a physician and intensive
Jekk dawn ir- reazzjonijiet iseħħu, dawn ikollhom bżonn l- attenzjoni immedjata ta ’ tabib u kura medika intensiva.
Particular attention should be paid to sudden sharp migraine-like headaches as a possible warning signal.
to Attenzjoni partikulari għandha tingħata lill- uġigħ ta ’ ras qisu emigranja, li jiġi għall- għarrieda, għax
th Increases in blood pressure may require treatment with anti-hypertensive medicines or dosing increase of
Żidiet fil- pressjoni tad- demm jista ’ jkollhom bżonn kura b’ mediċini kontra l- pressjoni jew żieda fid - dożaġġ ta ’ mediċini eżistenti kontra l- pressjoni għolja.
In addition, a reduction of the administered dose of Dynepo needs to be considered.
Flimkien ma ’ dan, tnaqqis tad- doża ta ’ Dynepo li tingħata għandha tiġi kkunsidrata.
If blood pressure values remain high, a transient interruption of Dynepo therapy may be required.
Jekk il- valuri tal- pressjoni tad- demm jibqgħu għoljin, interruzzjoni
er Once hypertension is controlled with more intensified therapy, Dynepo therapy should be re-started at a reduced dose. ng Iron evaluation lo
Evalwazzjoni tal- livell tal- ħadid
During Dynepo therapy, absolute or functional iron deficiency may develop.
Matul it- terapija b’ Dynepo, tista ’ tiżviluppa defiċjenza ’ g
This is the most common no
assoluta jew funzjonali tal- ħadid.
cause of an incomplete response to an erythropoietin therapy.
kawża komuni ta ’ rispons inkomplet għat- terapija eritropojetika.
Therefore, prior to and during Dynepo therapy, the patient's iron stores, including transferrin saturation and serum ferritin, should be evaluated.
Għalhekk, qabel u matul it- terapija b’ Dynepo, il- ħażna tal- ħadid tal- pazjent, li tinkludi s- saturazzjoni im
Transferrin saturation should be at least 20%, and ct
ta ’ transferrin u serum ferritin, għandha tiġi evalwata.
ferritin should be at least 100 ng/ ml.
Is- saturazzjoni ta ’ transferrin għandha tkun mill - inqas 20%, u dik ta ’ ferritin għandha tkun mill- inqas 100 ng/ ml.
If transferrin saturation falls below 20%, or if ferritin falls below du
Eventwalment kważi l - il
100 ng/ ml, iron should be administered.
pazjenti kollha ser ikunu jeħtieġu suppliment tal- ħadid biex iżidu jew iżommu s- saturazzjoni ta ’ al
Virtually all patients will eventually require supplemental iron to increase or maintain transferrin saturation and ferritin to levels that will adequately support erythropoiesis stimulated by Dynepo. ro
transferrin u ferritin għal livelli li jissapportjaw b’ mod adegwat l- erythropoiesis stimulata minn Dynepo. in
Anaemia in epoetin-resistant or hyporesponsive patients with failure to respond to 20,000 IU/ week lp
L- anemija f’ pazjenti li huma reżistenti jew iporisponsivi għal epoetin u ma jirrispondux għal 20, 000 IU/ ġimgħa għandha tiġi investigata.
should be investigated, including referral to a haematologist. a
Dan għandu jinkludi li jiġu riferuti għand ematoloġista. iċ ed
In the iron-replete patient with an inadequate response to Dynepo therapy, the following conditions should be evaluated and treated, if appropriated: in
F’ pazjenti li jkollhom ħadid biżżejjed iżda li jkollhom rispons inadegwat għat- terapija b’ Dynepo, il - kundizzjonijiet li ġejjin għandhom ikunu evalwati u kkurati, jekk ikun xieraq: • Infezzjoni/ infjammazzjoni m
• Infection/ inflammation ic
• Telf moħbi ta ’ demm • Iperparatirojdiżmu/ Osteitis fibrosa cystica t
• Occult blood loss ed
• Intossikazzjoni ta ’ l- aluminju ot
• Hyperparathyroidism/ Osteitis fibrosa cystica • Aluminium intoxication M
• Emoglobinopatiji bħal talessimja jew sickle cell anaemia od
• Haemoglobinopathies such as thalassaemia or sickle cell anaemia • Vitamin deficiencies, i. e., folic acid or vitamin B12 deficiencies • Haemolysis • Malignant diseases including multiple myeloma and myelodysplastic syndrome • Malnutrition
• Defiċjenzi tal- vitamini, i. e., defiċjenzi tal- folic acid jew ta ’ vitamina B12 • Emolisi • Mard malinn li jinkludi mjeloma multipla u s- sindrome mjelodisplastiku Pr
Laboratory monitoring
• Nuqqas ta ’ ikel sustanzjuż
It is recommended that a complete blood count and platelet count is performed regularly.
Monitoraġġ tal- laboratorju Hu rrakkomandat li għadd sħiħ tad- demm u għadd tal- plejtlets jitwettqu regolarment.
After any dose adjustment, the haemoglobin
Il- livell ta ’ l- emoglobina għandu jiġi stabbilit darba f’ ġimgħa sakemm jistabbilizza fil- medda ssuġġerita tal- mira, u d- doża tal- manutenzjoni tkun ġiet stabbilita.
4 should also be determined once weekly until it has stabilised in the target range.
Wara kwalunkwe aġġustament tad - doża, l- emoglobina għandha wkoll tiġi stabbilita darba f’ ġimgħa sakemm tistabbilizza fil- medda tal - mira.
The haemoglobin level should then be monitored at regular intervals.
Il- livelli ta ’ l- emoglobina għandhom imbagħad ikunu mmonitorjati f’ intervalli regolari.
Serum chemistry values including creatinine and potassium should be monitored regularly during Dynepo therapy.
4 Il- valuri tal- kimika tas- serum, li jinkludu kreatinina u potassium, għandhom jiġu mmonitorjati regolarment matul it- terapija b’ Dynepo.
Although it has not been observed with Dynepo, since anaphylactoid reactions may occur with erythropoietin, it is recommended that the first dose be administered under medical supervision.
Oħrajn Għalkemm ma kinux osservati b’ Dynepo, minħabba li reazzjonijiet anafilattojdi jistgħu jseħħu b’ erythropoietin, hu rrakkomandat li l- ewwel doża tingħata taħt superviżjoni medika.
The use of Dynepo in nephrosclerotic patients not yet undergoing dialysis should be defined
L- użu ta ’ Dynepo f’ pazjenti nefrosklerotiċi li għad mhux qed issirilhom id- dijaliżi, għandu jiġi definit individwalment, għax il- possibbiltà ta ’ l- aċċelerazzjoni tal- progressjoni tal- kollass tal- kliewi ma tistax tiġi
ed individually, as a possible acceleration of progression of renal failure cannot be ruled out with certainty.
t za eskluża b’ ċertezza.
is During haemodialysis, patients treated with Dynepo may require increased anticoagulation treatment
Matul l- emodijaliżi, il- pazjenti kkurati b’ Dynepo jista ’ jkollhom bżonn ta ’ żieda fil- kura kontra l -
or to prevent clotting of the arterio-venous shunt.
riz koagulazzjoni biex jiġi evitat it- tagħqid tad- demm tas- shunt arterjo- venuża.
th Misuse of epoetin by healthy persons may lead to an excessive increase in haemoglobin and haematocrit.
to L- użu ħażin ta ’ epoetin minn persuni b’ saħħithom jista ’ jwassal għal żieda eċċessiva fl- emoglobina u fl - ematokrit.
This may be associated with life-threatening cardiovascular complications
Dan jista ’ jkun assoċjat ma ’ komplikazzjonijiet kardjovaskulari ta ’ periklu għall- ħajja.
au 4.5 Interaction with other medicinal products and other forms of interaction
aw 4. 5 Interazzjoni ma prodotti oħra mediċinali u forom oħra ta` interazzjoni.
No interaction studies have been performed. er ng No interactions have been reported during treatment with Dynepo in the course of clinical trials. lo
x L- ebda studji ma saru fuq interazzjoni ta` mediċini oħra ma` Dynepo
4.6 Pregnancy and lactation no
du L- ebda interazzjonijiet ma kienu rrappurtati matul il- kura b’ Dynepo sakemm damu jsiru l- provi kliniċi. ħa 4. 6 Tqala u treddigħ ’ g
Animal studies are insufficient with respect to effects on pregnancy (see section 5.3).
Ir - im
The potential risk for humans is unknown.
riskju potenzjali għall- bnedmin mhuwiex magħruf.
Caution should be exercised when prescribing to pregnant ct
Wieħed għandu joqgħod attent meta jikteb riċetta għal din il- mediċina għal nisa tqal.
In case of its use during pregnancy, concomitant iron substitution should be considered in the mother. du
F’ każ ta ’ l- użu tagħha matul it- tqala, l- użu fl- istess ħin ta ’ sostituzzjoni tal- ħadid għandha tiġi kkunsidrata fl- omm. il
It is not known whether Dynepo is excreted in human breast milk.
Mhux magħruf jekk Dynepo jitneħħiex fil- ħalib tas- sider uman.
Since many compounds are excreted in human milk, caution should be advised when Dynepo is administered to breast-feeding ro
Minħabba li ħafna komposti jitneħħew fil- ħalib uman, għandha tingħata attenzjoni meta Dynepo jingħata li nisa li jkunu al
women. lp
qed ireddgħu. in
4.7 Effects on ability to drive and use machines a
4. 7 Effetti fuq is- sewqan u l- użu ta ’ magni iċ
Dynepo has no or negligible influence on the ability to drive and use machines. in ic
Dynepo m’ għandu l- ebda influwenza, jew influwenza negliġibbli, fuq il- ħila biex issuq jew tħaddem ed
4.8 Undesirable effects ed
4. 8 Effetti mhux mixtieqa
Approximately 10% of patients can be expected to experience an adverse drug reaction.
Madwar 10% tal- pazjenti huma mistennija li jġarrbu reazzjoni avversa tal- mediċina L- iktar komuni t ot
The most common are hypertension, access related thrombosis and headache.
huma pressjoni tad- demm għolja, trombożi marbuta ma ’ l- aċċess u wġigħ ta ’ ras.
Clinical experience with epoetins M
Esperjenza klinika bl- epoetins tissuġġerixxi li l- pressjoni għolja tad- demm u r- riskju ta ’ trombożi jistgħu jitnaqqsu billi od
suggest hypertension and thrombosis risk may be reduced by titrating the dose to maintain haemoglobin levels between 10 to 12 g/ dl.
jsir titraġġ tad- doża biex il- livelli ta ’ l- emoglobina jinżammu bejn 10 sa 12 g/ dl.
Body System
Sistema tal- Ġisem
> 1/ 1,000, < 1/ 100)
(> 1/ 1, 000, < 1/ 100) Poliċitemija Tromboċitosi
system disorders:
Disturbi tas- sistema nervuża:
Headache
Uġigħ ta ’ ras
Convulsions
Konvulżjonijiet
Hypertension
Pressjoni għolja
ed Gastrointestinal disorders:
t za Disturbi gastro- intestinali:
is Nausea
riz Dardir
Skin and subcutaneous tissues disorders:
Disturbi fil- ġilda u fit -
Pruritus
Ħakk tal- ġilda
th
to tessuti ta ’ taħt il- ġilda:
General disorders and
Disturbi ġenerali u
Access related
Trombożi marbuta
Pain
Uġigħ
au
aw
administration site conditions:
kundizzjonijiet ta ’ mnejn jingħata:
thrombosis
ma ’ l- aċċess
Injection site reaction (e. g. pain, haemorrhage)
Reazzjoni fis- sit ta ’ l - injezzjoni (eż. uġigħ, emorraġija)
er Flu-syndrome ng
x Sindrome ta ’
section 4.4). no
du influwenza ħa Żidiet fil- valuri tal- kimika fis- serum li jinkludu l- krejatinina u l- potassium kienu osservati (ara sezzjoni 4. 4). ’ g
4.9 Overdose
4. 9 Doża eċċessiva im
The maximum dose of epoetin delta that can be safely administered in single or multiple doses has not ct
Id- doża massima ta ’ epoetin delta li tista ’ tingħata b’ mod sikur f’ doża waħidha jew f’ dożi multipli ma ġietx stabbilita. il
been determined. du
Il- kura tista ’ tirriżulta f’ poliċitemija jekk l- emoglobina/ ematokrit ma tkunx immonitorjata bl - al
Treatment can result in polycythaemia if the haemoglobin/ haematocrit is not carefully monitored and the dose appropriately adjusted.
attenzjoni u d- doża tkun aġġustata kif suppost.
If the suggested target range is exceeded, treatment with epoetin delta ro
Jekk tinqabeż il- medda tal- mira ssuġġerita, il- kura b’ epoetin delta għandha tiġi temporanjament imwaqqfa sakemm l- emoglobina/ ematokrit terġa ’ lura in
should be temporarily withdrawn until the haemoglobin/ haematocrit returns to the suggested target range.
fil- medda tal- mira ssuġġerita.
Epoetin delta can then be reintroduced with a lower dosage (see section 4.2). lp
Epoetin delta jista ’ mbagħad jerġa ’ jiġi ntrodott f’ dożaġġ iktar baxx (ara iċ
If severe polycythaemia occurs, conventional methods (phlebotomy) may be indicated to decrease the a
sezzjoni 4. 2). ed
haemoglobin level. in ic
Jekk isseħħ poliċitemija severa, metodi konvenzjonali (flebotomija) jistgħu jkunu indikati biex inaqqsu l- livell ta ’ l- emoglobina. m
PHARMACOLOGICAL PROPERTIES ed
TAGĦRIF FARMAKOLOĠIKU t ot
5.1 Pharmacodynamic properties M
5. 1 Tagħrif farmakodinamiku od
Antianaemic - ATC code:
Antianemiku - Kodiċi ATC:
Erythropoietin is a glycoprotein that stimulates the formation of erythrocytes from precursors of the stem cell compartment.
Erythropoietin hu glikoproteina li tistimula l- formazzjoni ta ’ eritroċiti mill- prekursuri tal - kompartiment taċ- ċelluli staminali.
It acts as a mitosis stimulating factor and differentiation hormone.
Jaġixxi bħala fattur li jistimula l- mitosi u l- ormon tad - differenzazzjoni.
The biological efficacy of erythropoietin has been demonstrated after intravenous and subcutaneous administration in various animal models in vivo (rats and dogs).
L- effikaċja bijoloġika ta ’ erythropoietin intweriet wara l- għoti ġol- vina u taħt il- ġilda f’ mudelli varji ta ’ annimali in vivo (firien u klieb).
After administration of epoetin delta, the number of erythrocytes, the Hb values and reticulocyte counts increase as well as the 59Fe- incorporation rate.
Wara l- għoti ta ’ epoetin delta, in- numru ta ’ eritroċiti, il- valuri tal - Hb u l- għadd tar- reticuloċiti jiżdiedu, kif tagħmel ukoll ir- rata ta ’ l- inkorporazzjoni 59Fe.
During the clinical trials, there were no indications of development of neutralising antibodies to 6 epoetin delta in humans based on the clinical response.
6 jinnewtralizzaw, għal epoetin delta fil- bnedmin, ibbażati fuq ir- rispons kliniku.
When administration is halted, the eyrthropoietic parameters return toward baseline levels within the recovery period of 1-3 months.
Meta l- għoti jitwaqqaf, il- parametri eritropoietiċi jerġgħu lura lejn il- linja bażi livelli fi żmien il - perjodu ta ’ l- irkupru ta ’ 1- 3 xhur.
Subcutaneous administration results in a similar pattern of erythropoietic stimulation as after intravenous administration.
L- għoti taħt il- ġilda jirriżulta f’ andament simili ta ’ stimulazzjoni eritropoietika bħal dak ta ’ wara l- għoti ġol- vina.
Patients with cancer
Pazjenti li għandhom il- kanċer Dynepo mhuwiex indikat għall- immaniġġjar ta ’ anemija marbuta mal- kanċer.
Dynepo is not indicated for the management of anaemia associated with cancer.
Erythropoietin hu fattur tat- tkabbir (growth factor) li primarjament jistimula l- produzzjoni taċ- ċelluli l -
Erythropoietin is a growth factor that primarily stimulates red cell production.
t za ħomor.
Erythropoietin receptors may be expressed on the surface of a variety of tumour cells.
Ir- riċetturi ta ’ erythropoietin jistgħu jkunu espressi fuq il- wiċċ ta ’ varjetà ta ’ ċelluli tat- tumur
ed Survival and tumour progression have been examined in five large controlled studies of epoetin alfa, beta and darbepoetin alfa involving a total of 2,833 patients, of which four were double-blind placebo-
Is- sopravivenza u l- progressjoni tat- tumur kienu eżaminati f’ ħames studji kbar ikkontrollati ta ’ epoetin
is controlled studies and one was an open-label study.
riz alfa, beta u darbepoetin alfa, li kienu jinvolvu total ta ’ 2, 833 pazjent, li erba ’ minnhom kienu studji double- blind u kkontrollati bil- plaċebo, u wieħed kien studju open- label.
Two of the studies recruited patients who were
Tnejn mill- istudji kienu
or being treated with chemotherapy.
to jinkludu pazjenti li kienu qed ikunu kkurati bil- kimoterapija.
The target haemoglobin concentration in two studies was > 13 g/ dL; in the remaining three studies it was 12-14 g/ dL.
Il- konċentrazzjoni tal- mira ta ’ l - emoglobina fiż- żewġ studji kienet ta ’ > 13 g/ dL; fit- tliet studji l- oħrajn kienet ta ’ 12- 14 g/ dL.
In the open-label study there was no difference in
Fl -
th overall survival between patients treated with recombinant human erythropoietin and controls.
aw istudju open- label ma kien hemm l- ebda differenza fis- sopravivenza totali bejn pazjenti kkurati b’ erythropoietin uman rikombinanti u l- kontrolli.
In the four placebo-controlled studies the hazard ratios for overall survival ranged between 1.25 and 2.47 in
Dawn l -
These studies have shown a consistent unexplained statistically significant excess mortality in patients who have anaemia associated with various common cancers who received
x istudji wrew mortalità eċċessiva konsistenti li kienet statistikament sinifikanti, u li ma kinitx spjegabbli, f’ pazjenti li kellhom anemija assoċjata ma ’ diversi kanċers komuni, li rċivew
er recombinant human erythropoietin compared to controls.
du erythropoietin uman rikombinanti, meta mqabbla mal- kontrolli.
Overall survival outcome in the trials could not be satisfactorily explained by differences in the incidence of thrombosis and related complications ng between those given recombinant human erythropoietin and those in the control group. lo A systematic review has also been performed involving more than 9000 cancer patients participating in 57 clinical trials.
Ir- riżultat totali tas- sopravivenza fil - provi ma setax ikun spjegat b’ mod sodisfaċenti mid- differenzi fl- inċidenza ta ’ trombożi u ħa kumplikazzjonijiet marbuta bejn dawk il- pazjenti li ngħataw erythropoietin uman rikombinanti u dawk fil- grupp tal- kontroll. ’ g
Meta-analysis of overall survival data produced a hazard ratio point estimate of no
Saret ukoll evalwazzjoni sistematika li kienet tinvolvi iktar minn 9000 pazjent bil- kanċer li kienu qed im
1.08 in favour of controls (95% CI:
Meta- analiżi ta ’ dejta dwar is- sopravivenza totali, ipproduċiet hazard ratio point estimate ta ’ 1. 08 favur il- kontrolli (95% CI:
0.99, 1.18; 42 trials and 8167 patients).
0. 99, 1, 18; 42 prova u 8167 pazjent).
1.35, 2.06, 35 trials and 6769 patients) was observed in patients treated with recombinant human erythropoietin.
6769 pazjent) kienet osservata f’ pazjenti kkurati b’ erythropoietin uman rikombinanti.
There is therefore consistent evidence to ct
Għalhekk, hemm evidenza konsistenti li tissuġġerixxi li jista ’ jkun hemm ħsara sinifikanti lil pazjenti bil- kanċer li al
suggest that there may be significant harm to patients with cancer who are treated with recombinant human erythropoietin.
jkunu kkurati b’ erythropoietin uman rikombinanti.
The extent to which these outcomes might apply to the administration of du
Il- grad sa fejn dawn riżultati jistgħu japplikaw għall- għoti ta ’ erythropoietin uman rikombinanti lil pazjenti bil- kanċer, ikkurati bil- kimoterapija biex in
recombinant human erythropoietin to patients with cancer, treated with chemotherapy to achieve haemoglobin concentrations less than 13 g/ dL, is unclear because few patients with these ro
jintlaħqu konċentrazzjonijiet ta ’ emoglobina ta ’ inqas minn 13 g/ dL, mhuwiex ċar minħabba li ftit iċ
characteristics were included in the data reviewed.
pazjenti b’ dawn il- karatteristiċi kienu inklużi fid- dejta li kienet evalwata.
Survival outcomes and tumour progression in cancer patients that are being treated with Dynepo for anaemia associated with chronic renal failure lp
Ir- riżultati dwar is - sopravivenza u l- progressjoni tat- tumur f’ pazjenti bil- kanċer li kienu qed jiġu kkurati b’ Dynepo għall - ed
have not been investigated.
anemija assoċjata ma ’ insuffiċjenza kronika renali ma kinux investigati.
The extent to which the outcomes observed in the clinical studies discussed above may apply to this patient population is unclear, specifically considering that the a
Il- grad sa fejn ir- riżultati osservati fl- istudji kliniċi diskussi hawn fuq jistgħu japplikaw għal din il- popolazzjoni ta ’ pazjenti, m
dosages administered in the renal indication are lower than in the cancer indication. in
mhix ċara, speċifikament meta wieħed jikkunsidra li d- dożaġġi li ngħataw fl- indikazzjoni renali huma iktar baxxi mill- indikazzjoni tal- kanċer. t
5.2 Pharmacokinetic properties ic ed
5. 2 Tagħrif farmakokinetiku ot od
Following intravenous doses, M
Il- farmakokinetiċi ta ’ erythropoietin wara l- għoti ta ’ epoetin delta kienu eżaminati kemm f’ voluntiera b’ saħħithom u kemm f’ pazjenti b’ kollass kroniku tal- kliewi.
volume of distribution approximates total blood volume and ranges from 0.063 to 0.097 l/ kg.
Il- half- life ta ’ l - Pr
The elimination half-life ranges from 4.7 to 13.2 hours in patients.
eliminazzjoni tvarja minn 4. 7 sa 13. 2 sigħat fil- pazjenti.
Half life is approximately 50% shorter in healthy subjects.
Il- half life hi madwar 50% iqsar f’ persuni b’ saħħithom.
Measurable concentrations of erythropoietin are maintained in the serum for at least 24 hours following doses ranging from 50 IU/ kg to 300 IU/ kg.
Konċentrazzjonijiet ta ’ erythropoietin li jistgħu jitkejlu jinżammu fis- serum għal mill - inqas 24 siegħa wara dożi li jvarjaw minn 50 IU/ kg sa 300 IU/ kg.
Exposure to erythropoietin following administration of epoetin delta increases proportionately in patients given intravenous doses of 50 IU/ kg to 300 IU/ kg.
L- espożizzjoni għal erythropoietin wara l- għoti ta ’ epoetin delta tiżdied proporzjonalment f’ pazjenti li jingħataw dożi ta ’ 50 IU/ kg sa 300 IU/ kg ġol- vina.
No accumulation of epoetin delta was observed after repeated intravenous administration three times weekly.
L- ebda akkumulazzjoni ta ’ epoetin delta ma kienet osservata wara l- għoti ripetut ġol - vina tliet darbiet f’ ġimgħa.
Peak serum concentrations for subcutaneously administered epoetin delta occur between 8 and 36 hours following injection.
Konċentrazzjonijiet massimi fis- serum għal epoetin delta mogħti taħt il- ġilda jseħħu bejn 8 u 36 siegħa wara l- injezzjoni.
The half-life of subcutaneously administered epoetin delta is prolonged compared to intravenous administration and ranges from 27 to 33 hours in patients.
Il- half- life ta ’ epoetin delta mogħti taħt il- ġilda titwal meta mqabbla ma ’ l- għoti ġol - vina u tvarja minn 27 sa 33 siegħa fil- pazjenti.
The bioavailability of subcutaneously administered epoetin delta is between 26% and 36%.
Il- bijodisponibilità ta ’ epoetin delta mogħti taħt il- ġilda
7 5.3 Preclinical safety data
7 hi bejn 26% u 36%.
Animal studies conducted with both Dynepo and epoetin alfa in pregnant female rats and rabbits did not show any teratogenic effect, but indicated class-related reversible effects on growth and haematopoiesis in the offspring.
Studji fuq l- annimali li saru kemm b’ Dynepo u b’ epoetin alfa fuq firien u fniek tqal ma wrew l- ebda effett teratoġeniku, iżda indikaw effetti riversibbli relatati mal- klassi, fuq it- tkabbir u ematopoiesi fil - frieħ.
Effects in non-clinical studies were observed only at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use.
Fi studji li m’ humiex kliniċi, effetti dehru biss wara esponimenti meqjusa ferm aktar għolja mill - massimu ta ’ l- esponimenti lill- bnedmin, li juru ftit li xejn rilevanza ma ’ l- użu kliniku.
6.
t za 6.
6.1 List of excipients
riz 6. 1 Lista ta ’ sustanzi mhux attivi
ed Sodium phosphate monobasic, monohydrate
to Sodium phosphate monobasic, monohydrate Sodium phosphate dibasic, heptahydrate
or Polysorbate 20 Sodium chloride
aw Polysorbate 20 Sodium chloride Water for injections
au 6.2 Incompatibilities
x du 6. 2 Inkompatibilitajiet
er In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products. ng 6.3 Shelf-life lo
Minħabba li ma sarux studji li juru liema huma l- prodotti mediċinali li ma jaqblux miegħu, dan il - ħa prodott m’ għandux jitħallat ma ’ prodotti mediċinali oħrajn. ’ g 6. 3 Żmien kemm idum tajjeb il- prodott mediċinali im
2 years no
Sentejn
6.4 Special precautions for storage ct
6. 4 Prekawzjonijiet speċjali għall- ħażna il
Store in a refrigerator (2 C – 8 C).
Aħżen fi friġġ (2°C – 8°C).
Keep the syringes in the outer carton to protect from light. du
Żomm is- siringi fil- kartuna ta ’ barra sabiex al
Unopened pre-filled syringes may be kept un-refrigerated but below 25oC for a single maximum period of ro
Siringi mimlija għal- lest mhux miftuħa jistgħu jinżammu barra mill- friġġ, iżda f’ temperatura ta ’ inqas iċ
5 days.
minn 25oC għal perjodu wieħed sa massimu ta ’ 5 ijiem.
The revised expiry date for storage at below 25oC must not exceed the expiry date set in accordance with the 24 month shelf-life.
idum tajjeb ta ’ 24 xahar.
Following 5 days storage at below 25oC the pre-filled syringes lp
Wara 5 ijiem maħżuna f’ temperatura ta ’ inqas minn 25oC is- siringi mimlija għal - lest għandhom jintremew. m
must be discarded. a
6. 5 In- natura tal- kontenitur u ta ’ dak li hemm ġo fih t ot
6.5 Nature and contents of container in ic
Siringi mimlija għal- lest tal- ħġieġ ta ’ Tip 1 b’ tapp tal- lastku tal- bromobutyl, labra ta ’ l- azzar li ma jsaddadx 27 gauge.
Prefilled Type I glass syringe with bromobutyl rubber stopper, 27 gauge stainless steel needle with rigid natural rubber and polystyrene needle shield, polystyrene plunger rod and a needle safety guard. ed
Pakketti ta ’ 6 siringi mimlija għal- lest huma disponibbli.
M
6. 6 Prekawzjonijiet speċjali għar- rimi tal- prodott mediċinali mhux użat jew materjal ieħor għar - Pr
6.6 Special precautions for disposal of a used medicinal product or waste materials derived from such medicinal product and other handling of the product
rimi li huwa derivat minn dan il- prodott mediċinali u mmaniġġjar ieħor
When given subcutaneously, the site of injection should be rotated with each administration.
8 Meta jingħata taħt il- ġilda, is- sit ta ’ injezzjoni għandu jinbidel ma ’ kull għotja.
Inspect the pre-filled syringe before use.
Eżamina s- siringa mimlija għal- lest qabel l- użu.
It must only be used if the solution is clear, colourless, with no solid particles visible, and if it is of water-like consistency.
Għandha tintuża biss jekk is- soluzzjoni tkun ċara, bla kulur, bla ebda partikuli solidi li jkunu viżibbli u jekk ikollha konsistenza bħal dik ta ’ l- ilma.
Do not shake the syringe.
Iċċaqlaqx is- siringa.
Prolonged vigorous shaking may denature the active substance.
Jekk iċċaqlaq bis- saħħa għal- ħin twil, dan jista ’ jibdel in- natura tas- sustanza attiva.
The syringe is pre-assembled with a needle safety guard to prevent needle stick injury.
Is- siringa hi mmuntata minn qabel bi protezzjoni għas- sigurtà tal- labra biex jiġi evitat korriment ikkawżat mit- tingiż tal- labra.
This does not 8 affect normal operation of the syringe and the syringe can be rotated in the device.
Dan ma jaffettwax l- operat normali tas- siringa u s- siringa tista ’ tiddawwar fit- tagħmir.
Administer the amount required..
Agħti l- ammont meħtieġ.
When the injection has been administered the needle safety guard will cover the needle when releasing the plunger.
Meta l- injezzjoni tkun ingħatat, il- protezzjoni għas- sigurtà tal- labra ser tgħatti l -
Allow the syringe to move up until the entire needle is guarded.
Ħalli s- siringa timxi ’ l fuq sakemm il- labra kollha tkun protetta.
ed 8.
x du 8.
is EU/ 1/ 02/ 211/ 001
NUMRU( I) TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQħa EU/ 1/ 02/ 211/ 001 ’ g
DATE OF FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION
DATA TA ’ L- EWWEL AWTORIZZAZZJONI/ TIĠDID TA ’ L- AWTORIZZAZZJONI im
au Date of first authorisation:
Data ta ’ l- ewwel awtorizzazzjoni:
18 March 2002 Date of last renewal:
18 ta ’ Marzu, 2002 Data ta ’ l- aħħar tiġdid:
18 March 2007
18 ta ’ Marzu, 2007 il al
DATE OF REVISION OF THE TEXT lo no
DATA TA ’ META ĠIET RIVEDUTA L- KITBA in iċ
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/. ct du ro ed M
Informazzjoni dettaljata dwar dan il- prodott tinsab fuq il- website ta ’ l- Aġenzija Ewropea dwar il - Mediċini (EMEA) http: // www. emea. europa. eu / ed m t ot od Pr
Dynepo 2,000 IU/ 0.5 ml solution for injection in a pre-filled syringe.
Dynepo 2, 000 IU/ 0. 5 ml soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest.
Pre-filled syringe containing 2,000 IU per 0.5 ml dose (4,000 IU/ ml) of the active substance epoetin delta.
Siringa mimlija għal- lest li fiha 2, 000 IU f’ kull doża ta ’ 0. 5 ml (4, 000 IU/ ml) tas- sustanza attiva epoetin delta.
For a full list of excipients, see section 6.1.
t za Għal lista kompleta ta ’ sustanzi mhux attivi, ara sezzjoni 6. 1.
is or Solution for injection in a pre-filled syringe Clear, colourless and waterlike.
Soluzzjoni ċara, bla kulur u qisha ilma.
th au 4.
aw 4.
Therapeutic indications
x du 4. 1 Indikazzjonijiet terapewtiċi
Dynepo is indicated for the treatment of symptomatic anaemia associated with chronic renal failure (CRF) in adult patients.
Dynepo hu indikat għall- kura ta ’ anemija sintomatika assoċjata ma ’ insuffiċjenza renali kronika (CRF) ħa f’ pazjenti adulti.
It may be used in patients on dialysis and in patients not on dialysis. lo no
Jista ’ jintuża kemm f’ pazjenti li huma fuq id- dijaliżi kif ukoll f’ pazjenti li mhumiex fuq id- dijaliżi. ’ g
4.2 Posology and method of administration
4. 2 Pożoloġija u metodu ta ’ kif għandu jingħata im
Treatment with Dynepo should be initiated by physicians experienced in the treatment of anaemia ct
Il- kura b’ Dynepo għandha tinbeda minn tobba li għandhom esperjenza fil- kura ta ’ anemija assoċjata ma ’ CRF. il
associated with CRF. du
Id- dożaġġ ta ’ Dynepo jrid ikun aġġustat individwalment biex iżomm il- livell ta ’ l- emoglobina fil - al
The dosage of Dynepo must be adjusted individually to maintain the level of haemoglobin within the target range of 10 to 12g/ dl. ro
medda tal- mira ta ’ 10 sa 12g/ dl. in
Anaemia symptoms and sequelae may vary with age, gender, and overall burden of disease; a lp
Sintomi ta ’ anemija u kundizzjonijiet jew mard b’ konsegwenza tagħha jistgħu jvarjaw ma ’ l- età, sess, iċ
physician’ s evaluation of the individual patient ’ s clinical course and condition is necessary.
u l- gravità totali tal- marda; hemm bżonn ta ’ evalwazzjoni ta ’ tabib tal- kors kliniku u tal- kundizzjoni tal- pazjent individwali.
Dynepo should be administered either subcutaneously or intravenously in order to increase haemoglobin to not a
Dynepo għandu jingħata minn taħt il- ġilda jew ġol- vina biex iżid l- emoglobina ed
greater than 12 g/ dL (7.5 mmol/ L).
għal mhux iktar minn 12 g/ dL (7. 5 mmol/ l).
Subcutaneous use is preferable in patients who are not receiving in
L- użu taħt il- ġilda hu preferibbli f’ pazjenti li mhux qed jirċievu l- emodijalisi biex jevitaw li jtaqqbu vini periferali m
haemodialysis to avoid puncture of peripheral veins. ic
Il- varjabilità ta ’ l- emoglobina għandha tkun t ot
Due to intra-patient variability, occasional individual haemoglobin values for a patient above and ed
indirizzata permezz ta ’ l- immaniġġjar tad- doża, b’ konsiderazzjoni għall- medda tal- mira ta ’ l - emoglobina ta ’ 10 g/ dL (6. 2 mmol/ l) sa 12 g/ dL (7. 5 mmol/ l).
below the desired haemoglobin level may be observed.
Livell sostnut ta ’ emoglobina ta ’ iktar od
A sustained haemoglobin level of greater than 12 g/ dL (7.5 mmol/ l) should be avoided; guidance for appropriate dose adjustment for when haemoglobin values exceeding 12 g/ dL (7.5mmol/ l) are observed, are described below (see Dose Management section below).
Pr
Starting dose is 50 IU/ kg three times a week if administered intravenously.
10 Immaniġġjar tad- Doża Id- doża tal- bidu hi ta ’ 50 IU/ kg tliet darbiet f’ ġimgħa jekk tingħata ġol- vina.
In consequence, dose adjustment should not
Minħabba ż- żmien meħtieġ għal erythropoiesis, intervall ta ’ madwar 4 ġimgħat jista ’ jgħaddi bejn meta jsir aġġustament tad- doża (il- bidu, iż- żieda, it- tnaqqis jew it- twaqqif) u tibdil
ed be made more frequently than once a month, unless clinically indicated.
Bħala konsegwenza, l- aġġustament tad- doża m’ għandux isir iktar minn darba f’ xahar, ħlief jekk klinikament indikat.
Dose should be decreased by 25% – 50% or treatment temporarily withdrawn and then re-introduced
riz Id- doża għandha titnaqqas b’ 25% – 50% jew il- kura titwaqqaf temporanjament u mbagħad tinbeda mill- ġdid b’ dożaġġ iktar baxx jekk:
or
to
Administration er ng Dynepo may be administered intravenously or subcutaneously.
du Kif Jingħata Dynepo jista ’ jingħata ġol- vina jew taħt il- ġilda.
Subcutaneous self administration may lo be used after training by a medical professional. no
L- għoti ta ’ injezzjoni taħt il- ġilda mill- pazjent stess, ħa jista ’ jsir wara taħriġ minn persuna medika professjonali.
The required weekly dose of Dynepo is lower when Dynepo is administered subcutaneously compared to intravenously. ct
Id- doża meħtieġa ta ’ kull ġimgħa ta ’ Dynepo hi iktar baxxa meta Dynepo jingħata taħt il- ġilda meta ’ g
For subcutaneous injection, the whole length of the needle should be inserted perpendicularly into a skin fold held between thumb and forefinger, the skin fold should be held throughout the injection. du
Din il- parti tal- ġilda għandha tinżamm waqt l - il
Discard the syringe after initial single use. ro
Armi s- siringa wara użu wieħed inizjali. in
Special populations lp
Popolazzjonijiet speċjali iċ
Dynepo is not indicated for the management of anaemia associated with cancer. a in
Dynepo mhuwiex indikat għall- immaniġġjar ta ’ anemija marbuta mal- kanċer. ed