qanastek/EMEA-V3 huggingface dataset:
To minimise the dose of radiation absorbed by the bladder, the intake of fluids should be increased during the first few hours after injection to permit frequent voiding.
Biex titnaqqas id- doża ta 'radjazzjoni li tkun assorbita mill- borża ta' l- urina, it- teħid tal- fluwidi għandu jiżdied fl- ewwel ftit sigħat wara l- injezzjoni biex ikun hemm tneħħija frekwenti.
Taking other medicines There is only limited data available regarding interactions with other products.
Hemm biss tagħrif limitat dwar l- interazzjonijiet ma 'prodotti oħra.
Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed.
Jekk jogħġbok għarraf lit- tabib jew lill- ispiżjar tiegħek jekk qed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki mhux bir- riċetta.
Pregnancy and breast-feeding You should tell your doctor if there is any possibility that you are pregnant, or if you are breast- feeding.
Tqala u Treddigh Għandek tgħid lit- tabib jekk hemm possibilita` li int tqila, jew jekk qed tredda`.
Driving and using machines No studies on the effects on the ability to drive and use machines have been performed.
Sewqan u tħaddim ta ’ magni L- ebda effetti magħrufa.
However, it is not considered likely that NeoSpect will affect your ability to drive or to operate machinery.
Madankollu, NeoSpect mhux mistenni li jaffettwa l- ħila tiegħek li ssuq jew li tħaddem il- magni.
HOW TO USE NeoSpect
KIF GĦANDEK TUŻA NeoSpect
Dosage and administration
Dożaġġ u għoti
NeoSpect is for use in patients over the age of 18 years.
NeoSpect jintuża f’ pazjenti li għandhom iktar minn 18- il sena.
The recommended dosage is one vial (approximately 47 micrograms of depreotide) labelled with 555-740 MBq of technetium-99m.
Id- doża rakkomandata hija fjala waħda (bejn wieħed u ieħor 47 mikrogramma ta 'depreotide) tikkettati b' 555- 740MBq ta' technetium- 99m.
Radiolabelled NeoSpect is administered as a single injection into a vein.
NeoSpect radjutikkettat jingħata b' injezzjoni waħda fil- vina.
After labelling with the radioactive sodium pertechnetate (99mTc) solution for injection, radiolabelled NeoSpect will be injected before the scan is taken.
Wara t- tikkettar bis- soluzzjoni radjuattiva għall- injezzjoni, sodium pertechnetate (99mTc), NeoSpect radjutikkettat ikun injettat qabel ma tittieħed l- iskan.
The scanning may take place 2-4 hours after injection of NeoSpect.
L- iskan jista 'jittieħed minn 2- 4 sigħat wara l- injezzjoni ta' NeoSpect.
Any 99mTc-depreotide which remains in your body, will naturally lose its radioactivity within 2-3 days.
99m Tc- depreotide li jibqa 'fil- ġisem tiegħek jitlef ir- radjuattivita` tiegħu malajr fi żmien jumejn jew tlett ijiem.
Because there are strict laws covering the use, handling and disposal of radioactivity, NeoSpect will always be used in a hospital or a similar setting.
Billi hemm regoli stretti dwar l- użu, l- immaniġġar u r- rimi ta 'radjuattivita`, NeoSpect dejjem se jintuża fi sptar jew f' ambjent simili.
It will only be handled and administered by people who are trained and qualified in the safe handling of radioactive material.
Se jkun ippreparat u mgħoti biss minn nies li huma mħarrġa u kwalifikati fl- użu ta 'materjal radju- attiv, b' sigurta`.
Overdose If overdose is suspected, symptomatic treatment will be administered.
Jekk ikun hemm suspett ta 'doża eċċessiva, tingħata kura sintomatika.
Your doctor may recommend that you drink plenty of fluids to speed removal of traces of the radiopharmaceutical from your body.
It- tabib tiegħek jista 'jirrakkomanda li int tixrob ħafna fluwidi biex iżżid ir- rata li biha jitneħħew it- traċċi tal- prodott radjufarmaċewtiku minn ġismek.
Like all medicines, NeoSpect can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, NeoSpect jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
20 Most of the side effects reported were transient and of mild intensity.
Il- biċċa l- kbira ta 'l- effetti mhux mixtieqa għaddew u kienu moderati.
Most frequently reported were:
L- iktar li ġew rappurtati kienu:
* abdominal pain *
* uġigħ ta; ras * remettar * uġigħ addominali * fawra fil- wiċċ
* flushing *
* dardir * dijarrea * sturdament * għeja
Keep out of the reach and sight of children.
KIF TAĦŻEN NeoSpect Żommu fejn ma jintaħaqx u ma jidhirx mit- tfal.
Do not use NeoSpect after the expiry date which is stated on the label.
It- tikketta tal- prodott tinkludi l- kondizzjonijiet xierqa ta ’ kif għandu jinħażen u u d- data ta 'meta jiskadi l- prodott.
Trained hospital staff will ensure the correct storage of NeoSpect.
L- istaff ta 'l- isptar jaċċertaw li NeoSpect jinħażen kif suppost.
What NeoSpect contains
X' fih NeoSpect:
- The active substance is 47 micrograms depreotide as depreotide trifluoroacetate.
• Is- Sustanza attiva hija 47 mikrogramma ra 'depreotide bħala depreotide trifluoroacetate. • L- ingredjenti l- oħra huma sodium glucoheptonate dihydrate, stannous chloride dihydrate, disodium edetate u hydrochloric acid u/ jew sodium hydroxide biex jibbilanċja l- pH.
What NeoSpect looks like and contents of the pack
Id- Dehra ta ’ NeoSpect u d- daqs tal- pakkett:
The product is a kit for radiopharmaceutical preparation.
Dan il- prodott huwa sett għall- preparazzjoni radjufarmaċewtika.
NeoSpect is a powder for solution for injection that has to be dissolved and labelled with radioactive technetium before use.
NeoSpect huwa trab għal soluzzjoni għall- injezzjoni li jrid jiddewweb u jkun tikkettat b' technetium radjuattiv qabel jintuża.
When a solution of the radioactive substance sodium pertechnetate (99mTc) is added to the vial, 99mTc-depreotide is formed.
Meta soluzzjoni tas- sustanza radjuattiva, sodium pertechnetate (99mTc) tiżdied fil- fjala, jiġi ffurmat 99mTc- depreotide.
This solution is ready for injection into a vein.
Din is- soluzzjoni hija lesta biex tiġi injettata fil- vina.
Pack sizes
Daqsijiet tal- Pakketti
1 vial containing 47 micrograms of depreotide.
Kunjett 1 fih 47 mikrogramma ta 'depreotide.
5 vials, each vial containing 47 micrograms of depreotide.
5 kunjetti, kull kunjett fih 47 mikrogramma ta 'depreotide.
Marketing Authorisation Holder:
Id- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq u l- Manifattur:
21 Manufacturer responsible for batch release:
20 Il- manifattur responsabbli mir- rilaxx tal- lott:
It explains how
riz Dan id- dokument huwa sommarju tar- Rapport ta ’ Valutazzjoni Pubblika Ewropew (EPAR). Huwa jispjega kif il- Kumitat għal Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) ivvaluta l- istudji
is the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.
to mwettqin, biex jissodisfa ir- rakkomandazzjonijiet tagħhom dwar kif tintuża l- mediċina.
If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part
aw Jekk teħtieġ iktar tagħrif dwar il- kundizzjoni medika jew it- trattament tiegħek, aqra l- Fuljett ta 'Tagħrif (li hu wkoll parti mill- EPAR) jew kellem lit- tabib jew spiżjar tiegħek. Jekk trid aktar informazzjoni abbażi tar- rakkomandazzjonijiet ta ’ CHMP, aqra d- Diskussjoni Xjentifika (ukoll parti mill- EPAR).
er What is Nespo?
X’ inhu Nespo?
Nespo is a solution for injection in a vial, a pre-filled syringe or a pre-filled pen.
Nespo huwa soluzzjoni għall- injezzjoni f’ kunjett, siringa mimlija għal- lest jew pinna mimlija għal - lest.
It contains the active ng substance darbepoetin alfa.
Huwa fih is- sustanza attiva darbepoetin alfa.
Nespo exists in various strengths, from 10 to 500 micrograms per millilitre.
Nespo jeżisti f’ diversi qawwiet, minn 10 sa 500 mikrogramma kull millilitru.
See the Package Leaflet for full details. lo
Ara l- Fuljett tal- Pakkett għad- dettalji sħaħ. ’ g
What is Nespo used for? no
Għal xiex jintuża Nespo? im
Nespo is used to treat anaemia (fewer red blood cells in the blood than normal) in two groups of patients: • adults and children over one year of age with anaemia caused by long-term kidney failure, when ct
Nespo jintuża biex jikkura anemija (inqas ċelloli tad- demm ħomor fid- demm min- normal) f’ żewġ gruppi ta ’ pazjenti: • Adulti u tfal ta ’ aktar minn sena b’ anemija ikkaġunata minn indeboliment tal- kliewi fuq tul ta ’ il
the body does not produce enough of the natural hormone erythropoietin, du
żmien, meta l- ġisem ma jipproduċix biżżejjed mill- ormon naturali erythropoietin. al
The ro
• Pazjenti adulti b’ ċerti tipi ta ’ kanċer li qed jirċievu kimoterapija (il- mediċini użati biex jikkuraw il- kanċer), meta l- kimoterapija twaqqaf lill- mudullun milli jipproduċi biżżejjed ċelloli tad- demm. in
types of cancer where Nespo can be used are ‘ non-myeloid’ (do not affect the bone marrow).
It- tipi ta ’ kanċer fejn jista ’ jintuża Nespo huma ‘ non- myeloid ’ (ma jaffettwawx il- mudullun).
The medicine can only be obtained with a prescription. lp
Il- mediċina tista ’ tinkiseb biss b’ riċetta ta ’ tabib. iċ ed
How is Nespo used? a
Kif jintuża Nespo?
Nespo treatment should be initiated by a doctor who has experience in treating either of the two types in
Il- kura b’ Nespo għandha tinbeda minn tabib li għandu esperjenza fil- kura ta ’ kemm waħda u kemm l - oħra miż- żewġ tipi ta ’ anemiji msemmija hawn fuq.
Nespo is injected intravenously (into a vein) or subcutaneously (under the skin).
Nespo huwa injettat fil- vina jew taħt il- ġilda.
The dose used depends on why Nespo is used, varying from 0.45 micrograms per kilogram ic
Id - m
every week (or 0.75 micrograms/ kg every other week) in adults and children with kidney failure aged ed
doża użata tiddependi fuq għalfejn ħa jintuża Nespo, tvarja minn 0. 45 mikrogrammi kull kilogramm kull ġimgħa (jew 0. 75 mikrogrammi/ kg kull ġimgħa iva u ġimgħa le) fl- adulti u tfal ta ’ etajiet ta ’ 11- il t
11 years or older, to 6.75 micrograms/ kg every three weeks in cancer patients.
sena jew akbar b’ indeboliment tal- kliewi, għal 6. 75 mikrogrammi/ kg kull tlett ġimgħat f’ pazjenti bil - ot
Lower doses may be necessary for children with kidney failure aged 10 years or below.
Fil- każijiet kollha d- dożi huma aġġustati biex jinkisbu livelli ta ’ emoglobina li jibqgħu fi ħdan il- medda irrikmandata.
In all cases the doses are adjusted to obtain haemoglobin levels that remain within the recommended range.
L- emoglobina hija l- proteina fiċ- ċelloli ħomor tad- demm li ġġorr l- ossiġenu od
red blood cells that carries oxygen around the body.
madwar il- ġisem.
Doses and dose frequency (how often Nespo is given) are adjusted depending on the response.
Nespo Pr
Nespo is supplied ready for use in a pre-filled syringe or pre-filled pen, which can be used by the patient or their carer.
huwa fornut lest għall- użu f’ siringa mimlija għal- lest jew f’ pinna mimlija għal- lest, li tista ’ tintuża mill- pazjent jew minn min jieħu ħsiebu.
See the Package Leaflet for full instructions for use.
Ara l- Fuljett ta ’ tagħrif għall- istruzzjonijiet sħaħ dwar l- użu.
How does Nespo work?
Kif jaħdem Nespo?
A hormone called erythropoietin stimulates the production of red blood cells from the bone marrow.
Ormon imsejjaħ erythropoietin jistimula l- produzzjoni ta ’ ċelloli ħomor fid- demm mill- mudullun.
Darbepoetin alfa, the active substance in Nespo, acts exactly like the natural erythropoietin made by the body, but it is very slight different in its structure, and this means that darbepoetin alfa has a longer duration of action, and can be given less often than natural erythropoietin.
Darbepoetin alfa, is- sustanza attiva f’ Nespo, taħdem eżattament bħal erythropoietin naturali magħmul mill- ġisem, iżda hija xi ftit differenti fl- istruttura tagħha, u dan ifisser li darbepoetin alfa għandha tul ta’ azzjoni aktar twila, u tista ’ tingħata inqas ta ’ spiss minn erythropoietin naturali.
Darbepoetin alfa is 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Darbepoetin alfa 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged produced by a method known as ‘ recombinant DNA technology’: it is made by a cell that has received a gene (DNA), which makes the cell able to produce darbepoetin alfa.
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged hija magħmula permezz ta ’ metodu magħruf bħala ‘ teknoloġija rekombinanti tad- DNA ’, li tagħmel liċ- ċellola kapaċi tipproduċi darbepoetin alfa.
In patients with long-term kidney failure, the main cause of their anaemia is a lack of natural erythropoietin.
F’ pazjenti b’ indeboliment tal- kliewi fuq tul ta ’ żmien, il- kaġun prinċipali ta ’ l- anemija tagħhom huwa nuqqas ta ’ erythropoietin naturali.
A lack of natural erythropoietin is also one of the causes of anaemia in patients receiving chemotherapy.
Nuqqas ta ’ erythropoietin naturali huwa ukoll wieħed mill- kaġuni ta ’ anemija f’ pazjenti li jkunu qed jirċievu l - kimoterapija.
Nespo works by stimulating the production of red blood cells in the same way as natural erythropoietin.
Nespo jaħdem billi jistimola l- produzzjoni ta ’ ċelloli ħomor tad- demm bl- istess mod bħal erythropoietin naturali.
How has Nespo been studied?
Kif ġie studjat Nespo?
The effectiveness of Nespo has been studied in patients with long-term kidney disease, where it was compared with recombinant human erythropoietin in four studies involving over 1,200 patients, and in patients receiving chemotherapy for cancer such as lung cancer, myeloma or lymphoma, where it was compared with placebo (a dummy treatment) in two studies involving 669 patients.
t za f’ pazjenti li qed jirċievu kimoterapija għal kanċer bħal ma ’ huwa kanċer tal- pulmun, majeloma jew limfoma, fejn tqabbel ma ’ plaċebo (trattament finta) f’ żewġ studji li jinvolvu 669 pazjent.
The main measure of effectiveness in patients with kidney disease was the increase in haemoglobin.
Il- miżura ewlenija ta ’ l- effettività f’ pazjenti b’ mard tal- kliewi kienet iż- żieda fl- emoglobina.
In patients receiving
F’ pazjenti li qed
ed chemotherapy, the main measure of effectiveness was the reduction in number of patients who needed a blood transfusion.
riz jirċievu kimoterapija, il- miżura ewlenija ta ’ l- effettività kienet it- tnaqqis fin- numru ta ’ pazjenti li kienu jeħtieġu trasfużjoni tad- demm.
Nespo has also been studied in 124 children with long-term kidney disease to check that it is absorbed
Nespo ġie studjat ukoll f’ 124 tifel u tifla b’ mard tal- kliewi fit- tul
is in the same way as in adults.
to biex jiċċekkjaw li huwa assorbit bl- istess mod bħal fl- adulti.
or What benefit has Nespo shown during the studies?
aw X’ benefiċċu wera Nespo waqt l- istudji?
th Nespo was as effective as human recombinant erythropoietin at increasing the haemoglobin levels in
Nespo kien effettiv daqs erythropoietin rekombinanti tal- bniedem fiż- żieda ta ’ livelli ta ’ emoglobina f’ pazjenti b’ mard tal- kliewi, u biex iżomm dawn il- livelli mantenuti wara li jkunu ttejjbu, kemm jekk
au patients with kidney disease, and at keeping these levels maintained after they had been improved, whether given as an intravenous or subcutaneous injection.
F’ pazjenti bil- kanċer li qed jirċievu kimoterapija, inqas pazjenti ikkurati b’ Nespo kellhom bżonn trasfużjoni tad- demm meta mqabbla ma ’
In cancer patients receiving chemotherapy, fewer patients treated with Nespo needed a blood transfusion compared with those given placebo.
X’ inhu r- riskju assoċjat ma ’ Nespo?
What is the risk associated with Nespo? er ng The most common side effects with Nespo (seen in between 1 and 10 patients in 100) are headache, hypertension (high blood pressure), thrombosis (blood clots), injection site pain, arthralgia (joint pain) lo and peripheral oedema (fluid retention).
L- aktar effetti sekondarji komuni b’ Nespo (dehru f’ madwar 1 u 10 pazjenti minn kull 100) huma uġigħ ta ’ ras, pressjoni għolja, trombożi (ċapep tad- demm), uġigħ fis- sit ta ’ l- injezzjoni, artralġja ’ g
For the full list of all side effects reported with Nespo, see the Package Leaflet. no
Għal- lista sħiħa ta ’ l- effetti sekondarji kollha im
Nespo should not be used in people who may be hypersensitive (allergic) to darbepoetin alfa or any of the other ingredients, or in patients who have poorly controlled high blood pressure. ct
Nespo m’ għandux jintuża f’ nies li huma sensittivi żżejjed (allerġiċi) għal darbepoetin alfa jew għal xi sustanza oħra tiegħu, jew f’ pazjenti li għandhom pressjoni għolja mhux ikkontrollata sew. il
Why has Nespo been approved?
Għalfejn ġie approvat Nespo? al
The Committee for Medicinal Products for Human Use (CHMP) decided that Nespo’ s benefits are du
Il- Kumitat għal Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ Nespo huma akbar mir- riskji tiegħu għall- kura ta ’ anemija assoċjata ma ’ falliment renali kroniku fl - in
greater than its risks for the treatment of anaemia associated with chronic renal failure in adults and paediatric patients, and of symptomatic anaemia in adult cancer patients with non-myeloid ro
adulti u f’ pazjenti pedjatriċi, u ta ’ anemija sintomatika f’ pazjenti adulti bil- kanċer b’ malinni iċ
malignancies receiving chemotherapy.
‘ non- myeloid ’ li qed jirċievu kimoterapija.
The Committee recommended that Nespo be given marketing authorisation. lp
Il- Kumitat irrakkomanda li Nespo jingħata awtorizzazzjoni għat- tqegħid fis- suq. ed
Other information about Nespo: a
Tagħrif ieħor dwar Nespo:
The European Commission granted a marketing authorisation valid throughout the European Union in
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- Unjoni Ewropea m
for Nespo to Dompé Biotec S. p. A. on 8 June 2001.
kollha għal Nespo lil Dompé Biotec S. p. A. fit- 8 ta ’ Ġunju 2001.
The marketing authorisation was renewed on 8 June 2006. ic ed
L- awtorizzazzjoni għat- tqegħid fis - suq ġiet imġedda fit- 8 ta ’ Ġunju 2006. t ot
M
L- EPAR sħiħ għal Nespo huwa disponibbli minn hawnhekk. od
This summary was last updated in 09-2007.
Pr
d EU Number
at Numru ta ’ l- EU
Invented
Isem inventat
Pharmaceutical
Għamla farmaċewtika
name
siringa mimlija
Form
0. 4 ml (25 µg/ ml)
Administration
Siringa waħda
1 pre-filled syringe
4 siringi mimlija
pre-filled syringe (glass)
ġilda jew għal ġol- vini
0.4 ml (25 µg/ ml)
siringa mimlija
4 pre-filled syringes
Siringa waħda
Solution for
Soluzzjoni għall -
Subcutaneous or
Użu għal taħt il -
u
ux
intravenous use
ġilda jew għal ġol- vini
syringe (glass)
għal- lest (ħġieġ)
syringe
mimlija għal- lest
a EU/ 1/ 01/ 184/ 004
d EU/ 1/ 01/ 184/ 004
4 pre-filled syringes
4 siringi mimlija
Solution for
Soluzzjoni għall - injezzjoni
Subcutaneous or
Użu għal taħt il - ġilda jew għal
pre-filled
għal- lest (ħġieġ)
0.5 ml (40 µg/ ml)
mimlija għal- lest
1 pre-filled
im ġol- vini
ge
l
intravenous use
siringa mimlija
syringe (glass)
0. 5 ml (40 µg/ ml)
syringe
4 siringi mimlija
pre-filled
li
0.5 ml (40 µg/ ml)
injezzjoni
4 pre-filled
ġilda jew għal
n
għal- lest (ħġieġ)
injection
għal- lest
intravenous use
a ġol- vini
syringe (glass)
siringa mimlija
syringes
0. 3 ml (100 µg/ ml)
0.3 ml (100 µg/ ml)
għal- lest
4 pre-filled
m ġol- vini
o
tt
syringe (glass)
0. 4 ml (100 µg/ ml)
syringes
Siringa waħda
Subcutaneous or intravenous use
Użu għal taħt il - ġilda jew għal
pre-filled
injezzjoni
0.4 ml (100 µg/ ml)
għal- lest
4 pre-filled
Isem inventat
du
Qawwa
injection
Il- pakkett
syringe (glass)
0. 5 ml (100 µg/ ml)
0.5 ml (100 µg/ ml)
għal- lest (ħġieġ)
1 pre-filled
mimlija għal- lest
ro
to
pre-filled
aw
0.5 ml (100 µg/ ml)
injezzjoni
4 pre-filled
ġilda jew għal ġol- vini
lp
għal- lest (ħġieġ)
syringe (glass)
0. 3 ml (200 µg/ ml)
0.3 ml (200 µg/ ml)
għal- lest (ħġieġ)
1 pre-filled syringe
mimlija għal- lest
a EU/ 1/ 01/ 184/ 014
d EU/ 1/ 01/ 184/ 014
pre-filled
siringa mimlija
4 pre-filled
4 siringi mimlija
in
ħa
syringe
0. 4 ml (200 µg/ ml)
0.4 ml (200 µg/ ml)
mimlija għal- lest
pre-filled syringe (glass)
għal- lest (ħġieġ)
0.4 ml (200 µg/ ml)
għal- lest
4 pre-filled syringes
siringa mimlija
pre-filled
Siringa waħda
0.5 ml (200 µg/ ml)
iċ għal- lest (ħġieġ)
1 pre-filled
injezzjoni
M
ġilda jew għal ġol- vini
injection
mimlija għal- lest
intravenous use
ed
syringe
0. 5 ml (200 µg/ ml)
0.5 ml (200 µg/ ml)
għal- lest
Invented
m ġol- vini
Strength
tt
Pharmaceutical
siringa mimlija
Package size
0. 3 ml (500 µg/ ml)
0.6 ml (500 µg/ ml)
għal- lest (ħġieġ)
u
to
syringe (glass)
0. 6 ml (500 µg/ ml)
0.6 ml (500 µg/ ml)
għal- lest
4 pre-filled syringes
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d kunjett (ħġieġ) EU/ 1/ 01/ 184/ 024
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ġilda jew għal
4 vials
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in
injection
1 ml (40 µg/ ml)
intravenous use
Kunjett wieħed
vial (glass)
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1 ml (40 µg/ ml)
injezzjoni
c EU/ 1/ 01/ 184/ 028
ġilda jew għal ġol- vini
40 µg
ed
du
40 µg
injection
Soluzzjoni għall - injezzjoni
intravenous use
Użu għal taħt il - ġilda jew għal
EU/ 1/ 01/ 184/ 029
tt EU/ 1/ 01/ 184/ 029
1 vial
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1 ml (60 µg/ ml)
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siringa mimlija
1 pre-filled syringe (non-
0. 375 ml (40 µg/ ml)
M blister) d EU Number
Siringa waħda
Invented
ħa
Strength
injezzjoni
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ġilda jew għal ġol- vini
Route of
għal- lest (ħġieġ)
Packaging
mimlija għal- lest (mhux ġo folja)
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Package size
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1 pre-filled syringe (non-
siringa mimlija
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intravenous use
ġilda jew għal
syringe (non-
mimlija għal- lest
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a EU/ 1/ 01/ 184/ 037
in EU/ 1/ 01/ 184/ 037
1 pre-filled syringe (non-
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siringa mimlija
0.5 ml (100 µg/ ml)
mimlija għal- lest
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mimlija għal- lest
1 pre-filled syringe (non- blister)
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o EU/ 1/ 01/ 184/ 040
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1 pre-filled
Siringa waħda
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syringe (non- blister)
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0. 3 ml (500 µg/ ml)
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Siringa waħda
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0.3 ml (500 µg/ ml)
siringa mimlija
1 pre-filled syringe (non-
0. 6 ml (500 µg/ ml)
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siringa mimlija
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1 pre-filled
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intravenous use
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Subcutaneous use
Użu għal taħt il -
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1 pre-filled pen
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Invented
injezzjoni
Strength
ġilda
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in EU/ 1/ 01/ 184/ 047
pre-filled pen (glass)
pinna mimlija
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Subcutaneous
Użu għal taħt il -
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pinna mimlija
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0. 3 ml (200 µg/ ml)
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1 pre-filled pen
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Pinna waħda
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injection
ġilda
(glass) (SureClick)
għal- lest (ħġieġ) (SureClick)
ro EU/ 1/ 01/ 184/ 054
d EU/ 1/ 01/ 184/ 054
1 pre-filled pen
mimlija għal- lest
0.6 ml (500 µg/ ml)
mimlija għal- lest
1 pre-filled pen
1 ml (500 µg/ ml)
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EU Number
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Package size
għal- lest
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għal- lest
r (SureClick)
għal- lest
ge EU/ 1/ 01/ 184/ 062
r EU/ 1/ 01/ 184/ 062
n (SureClick)
għal- lest
pre-filled pen (glass) (SureClick)
pinna mimlija għal- lest (ħġieġ)
4 pre-filled pens
4 pinen mimlija għal- lest at
o EU/ 1/ 01/ 184/ 064
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tn
riz
(glass) (SureClick)
għal- lest (ħġieġ)
ro EU/ 1/ 01/ 184/ 066
aw EU/ 1/ 01/ 184/ 066
pre-filled pen (glass)
pinna mimlija għal- lest (ħġieġ)
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għal- lest
use
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siringa mimlija
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Siringa waħda
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Soluzzjoni għall -
intravenous use
Użu għal taħt il -
Strength
ġilda jew għal
Packaging
għal- lest
Package size
il ġol- vini
ris EU/ 1/ 01/ 184/ 071
al siringa mimlija EU/ 1/ 01/ 184/ 071
pre-filled syringe (glass)
0. 65 ml (200 µg/ ml)
1 pre-filled syringe (non-
Pinna waħda
0.65 ml (200 µg/ ml)
mimlija għal- lest
(glass)
0. 65 ml (200 µg/ ml)
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4 pinen mimlija
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m għal- lest
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ed is or th au ANNEX I er ng 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
Nespo 10 micrograms solution for injection in a pre-filled syringe.
Nespo 10 mikrogrammi soluzzjoni għall- injezzjoni ġo siringa mimlija għal- lest.
Each pre-filled syringe contains 10 micrograms of darbepoetin alfa in 0.4 ml (25 µg/ ml).
Kull siringa mimlija għal- lest fiha 10 mikrogrammi ta 'darbepoetin alfa f' 0. 4 ml (25 µg/ ml).
Darbepoetin alfa is produced by gene-technology in Chinese Hamster Ovary Cells (CHO-K1).
Darbepoetin alfa hija magħmula b’ teknoloġija ġenetika fiċ- Ċelluli Ovarji tal- Ħamster Ċiniż (CHO -
For excipients, see section 6.1.
Għal- lista kompleta ta ’ sustanzi mhux attivi, ara sezzjoni 6. 1.
ed is 3.
riz to 3.
or Solution for injection (injection) in a pre-filled syringe.
aw Soluzzjoni għall- injezzjoni (injezzjoni) ġo siringa mimlija għal- lest.
th au 4.
x 4.
er Treatment of symptomatic anaemia associated with chronic renal failure (CRF) in adults and ng paediatric patients. lo Treatment of symptomatic anaemia in adult cancer patients with non-myeloid malignancies receiving chemotherapy. no
Kura ta ’ l- anemija sintomatika assoċjata ma ’ insuffiċjenza renali kronika (CRF) f ’ pazjenti adulti u tfal. ’ g
4.2 Posology and method of administration ct
4. 2 Pożoloġija u metodu ta ’ kif għandu jingħata il al
Nespo treatment should be initiated by physicians experienced in the above mentioned indications. du
Il- kura b’ Nespo għandha tinbeda minn tobba li għandhom esperjenza fil- kura ta ’ l- indikazzjonijiet imsemmija hawn fuq. in
Nespo is supplied ready for use in a pre-filled syringe.
Nespo jiġi lest għall- użu ġo siringa mimlija għal- lest.
The instructions for use, handling and disposal are given in section 6.6. ro lp
L- istruzzjonijiet għall- użu, l- immaniġġjar u r - iċ
Treatment of symptomatic anaemia in adult and paediatric chronic renal failure patients
rimi huma mniżżla f’ sezzjoni 6. 6. ed
Anaemia symptoms and sequelae may vary with age, gender, and overall burden of disease; a a
Kura ta ’ l- anemija sintomatika f ’ pazjenti adulti u f 'pazjenti tfal li għandhom insuffiċjenza renali kronika m
physician’ s evaluation of the individual patient ’ s clinical course and condition is necessary.
Sintomi u problemi ta ’ anemija jistgħu jvarjaw skond l- età, is- sess, u l- piż ta ’ mard fuq kollox; evalwazzjoni minn tabib ta ’ l- istat kliniku u l- kundizzjoni tal- pazjent huma neċessarji.
Nespo in
Nespo għandu t ot
should be administered either subcutaneously or intravenously in order to increase haemoglobin to not ic
jingħata bħala injezzjoni taħt il- ġilda jew ġol- vina sabiex tiżdied il- konċentrazzjoni ta ’ l- emoglobina għal mhux aktar minn 12 g/ dl (7. 5 mmol/ l).
Subcutaneous use is preferable in patients who are not receiving haemodialysis to avoid the puncture of peripheral veins. ed
L- użu taħt il- ġilda huwa aħjar f’ pazjenti li mhux qegħdin od
below the desired haemoglobin level may be observed.
Minħabba varjazzjonijiet bejn pazjent u ieħor, jistgħu okkażjonalment jiġu osservati f’ pazjenti valuri ta ’ l- emoglobina ‘ l fuq jew taħt il- livell ta ’ l- emoglobina mixtieqa.
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).
Varjazzjoni fl- emoglobina għandha tiġi ndirizzata permezz ta ’ immaniġjar tad- doża, b ’ kunsiderazzjoni għat- targit ta ’ l- emoglobina ta ’ 10g/ dl (6. 2 mmol/ l) għal 12 g/ dl (7. 5mmol/ l).
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 (7.5 mmol/ l) are observed are described below.
Livell ta ’ l- emoglobina miżmum fit- tul għal aktar minn 12 g/ dl (7. 5 mmol/ l) għandu jiġi evitat; gwida għal aġġustament fid- doża xierqa għal meta l- valuri ta ’ l- emoglobina jaqbżu t- 12 g/ dl (7. 5 mmol/ l) huma murija hawn taħt.
A rise in haemoglobin of greater than 2 g/ dl (1.25 mmol/ l) over a four week period should be avoided.
Għandhom jiġu evitati żjidiet fl - emoglobina ta ’ aktar minn 2g/ dl (1. 25 mmol/ l) fuq perijodu ta ’ erba ’ ġimgħat.
If it occurs, appropriate dose adjustment should be made as provided.
Jekk dan jseħħ, għandu jsir aġġustament fid- doża kif meħtieġ.
Treatment with Nespo is divided into two stages – correction and maintenance phase.
2 Il- kura b’ Nespo hija maqsuma f’ żewġ stadji - fażi ta ’ korrezzjoni u fażi ta ’ manutenzjoni.
Guidance is given separately for adult and paediatric patients.
It- tmexxija f 'pazjenti adulti u f' pazjenti tfal hija mogħtija separatament.
Treatment of paediatric patients younger than 1 year of age has not been studied:
Il- kura f 'pazjenti tfal ta' anqas minn sena għad ma ġietx studjata:
2 Adult patients with chronic renal failure
Pazjenti adulti li għandhom insuffiċjenza renali kronika
Correction Phase
Fażi ta ’ korrezzjoni
The initial dose by subcutaneous or intravenous administration is 0.45 µg/ kg body weight, as a single injection once weekly.
Id- doża tal- bidu mogħtija taħt il- ġilda jew ġol- vina hija ta ’ 0. 45 μg/ kg piż tal- ġisem, bħala injezzjoni waħda darba fil- ġimgħa.
Alternatively, in patients not on dialysis, an initial dose of 0.75 μ g/ kg may be administered subcutaneously as a single injection once every two weeks.
Alternattivament, f 'pazjenti li mhumiex fuq dijalisi, doża tal- bidu ta' 0. 75
If the increase in haemoglobin is inadequate (less than 1 g/ dl (0.6 mmol/ l) in four weeks) increase the dose by approximately 25%.
Jekk iż- żjieda fl - emoglobina mhix biżżejjed (inqas minn 1 g/ dl (0. 6 mmol/ l) f’ erba ’ ġimgħat), id- doża trid tiżdied b ’ bejn wieħed u ieħor 25%.
Dose increases must not be made more frequently than once every four weeks.
Żjidiet fid- doża m ’ għandhomx jsiru aktar minn darba kull erba ’ ġimgħat.
If the rise in haemoglobin is greater than 2 g/ dl (1.25 mmol/ l) in four weeks reduce the dose by approximately 25%.
riz Jekk iż- żjieda fl- emoglobina tkun ta ’ aktar minn 2 g/ dl (1. 25 mmol/ l) f’ erba ’ ġimgħat, id- doża trid
ed considered.
to titnaqqas b ’ bejn wieħed u ieħor 25%.
If the haemoglobin continues to increase, the dose should be reduced by approximately 25%.
Jekk l- emoglobina taqbeż it- 12 g/ dl (7. 5 mmol/ l), tnaqqis fid - doża għandha tiġi kkunsidrata.
If after a dose reduction, haemoglobin continues to increase, the dose should be temporarily withheld until the haemoglobin begins to decrease, at which point therapy should be reinitiated at
Jekk il- livell ta ’ l- emoglobina jkompli jiżdied, wara tnaqqis fid- doża,
is approximately 25% lower than the previous dose.
aw id- doża għandha titwaqqaf temporanjament sa kemm il- livell ta ’ l- emoglobina jibda jonqos, fl ’ liema punt il- kura għandha terġa tinbeda b ’ doza ta ’ bejn wieħed u ieħor doża ta ’ 25% anqas mid- doża ta ’ qabel.
Thereafter the
Minn hemm ‘ il quddiem, l- emoglobina tista ’ titkejjel f’ intervalli itwal. ħa Fażi ta ’ manutenzjoni ’ g Fil- fażi ta ’ manutenzjoni, Nespo jista 'jkompli jingħata bħala injezzjoni waħda darba fil- ġimgħa jew darba kull ġimgħatejn.
th haemoglobin can be measured at longer intervals.
Pazjenti fuq dijalisi li qed ibiddlu minn doża ta 'Nespo ta' darba fil- ġimgħa għal im
er In the maintenance phase, Nespo may continue to be administered as a single injection once weekly or once every two weeks.
doża ta 'darba kull ġimgħatejn, fil- bidu għandhom jingħataw doża ekwivalenti għal darbtejn id- doża li qabel kienet tingħata darba fil- ġimgħa.
Dialysis patients converting from once weekly to once every other week dosing ng with Nespo should initially receive a dose equivalent to twice the previous once weekly dose.
F 'pazjenti mhux fuq dijalisi, la darba t- targit tal - konċentrazzjoni ta ’ emoglobina tkun ntlaħqet b' iddożar ta 'darba kull ġimgħatejn, Nespo jista' jingħata il
In patients not on dialysis, once the target haemoglobin has been achieved with once every two week lo dosing, Nespo may be administered subcutaneously once monthly using an initial dose equal to twice the previous once every two week dose. no
darba fix- xahar bħala injezzjoni taħt il- ġilda b 'doża tal- bidu ekwivalenti għal darbtejn id- doża li qabel kienet tingħata darba kull ġimgħatejn. al in
Dosing should be titrated as necessary to maintain the haemoglobin target. ct
L - iddożar għandu jiġi kkalkulat skond il- bżonn biex tinżamm il- konċentrazzjoni ta ’ emoglobina mixtieqa. iċ
If a dose adjustment is required to maintain haemoglobin at the desired level, it is recommended that the dose is adjusted by approximately 25%. du
Jekk aġġustament fid- doża hija meħtieġ biex tinżamm l- emoglobina fil- livell mixtieq, huwa ed
If the rise in haemoglobin is greater than 2 g/ dl (1.25 mmol/ l) in four weeks reduce the dose by ro
rrakkomandat li d- doża tiġi aġġustata b 'bejn wieħed u ieħor 25%. m
approximately 25%, depending on the rate of increase.
Jekk iż- żjieda fl- emoglobina tkun ta ’ aktar minn 2 g/ dl (1. 25 mmol/ l) f’ erba ’ ġimgħat, id- doża trid titnaqqas b 'bejn wieħed u ieħor 25%, skond ir- rata taż- żjieda.
If the haemoglobin exceeds 12 g/ dl (7.5 mmol/ l), a dose reduction should be considered.
Jekk l- emoglobina taqbeż it- 12 g/ dl (7. 5 mmol/ l), tnaqqis fid- doża għandha tiġi kkunsidrata.
If the haemoglobin continues to increase, the lp
Jekk l- emoglobina tkompli tiżdied, id- doża t ot
dose should be reduced by approximately 25%.
għandha tigi mnaqqsa bejn wieħed u ieħor b’ 25%.
If after a dose reduction, haemoglobin continues to increase, the dose should be temporarily withheld until the haemoglobin begins to decrease, at which a
Jekk wara tnaqqis fid - doża il- livell ta ’ l - emoglobina jkompli jizdied id- doża għandha titwaqqaf temporanjament sa kemm l- emoglobina tibda od
point therapy should be reinitiated at approximately 25% lower than the previous dose. in
Pr
provide adequate control of the symptoms of anaemia. ed
Il- pazjenti għandhom jiġu mmonitorjati mill- qrib biex jiġi assigurat li l- anqas doża ta ’ Nespo approvata tintuża biex jiġi pprovdut kontroll adegwat tas- sintomi ta ’ l- anemija.
M
Wara kull aġġustament fid- doża jew fl- iskeda l- emoglobina trid tiġi mmonitorjata kull ġimgħa jew ġimagħtejn.
Dose changes in the maintenance phase of treatment should not be made more frequently than every two weeks.
Bidliet fid- doża waqt il- fażi ta ’ manutenzjoni tal- kura m’ għandhomx jsiru aktar spiss minn kull ġimgħatejn.
When changing the route of administration the same dose must be used and the haemoglobin monitored every one or two weeks so that the appropriate dose adjustments can be made to keep the haemoglobin at the desired level.
3 Meta tibdel il- mod ta ’ kif jingħata l- prodott, l- istess doża trid tiġi wżata u l- emoglobina trid tiġi mmonitorjata kull ġimgħa jew ġimgħatejn ħalli l- aġġustamenti xierqa fid- doża jkunu jistgħu jsiru sabiex l- emoglobina tinżamm fil- livell mixtieq.
Clinical studies have demonstrated that adult patients receiving r-HuEPO one, two or three times weekly may be converted to once weekly or once every other week Nespo.
Studji kliniċi wrew li pazjenti adulti li jirċievu r- HuEPO darba, darbtejn jew tliet darbiet fil- ġimgħa jistgħu jibdlu għal Nespo darba fil- ġimgħa jew darba kull ġimgħatejn.
The initial weekly dose of Nespo (µg/ week) can be determined by dividing the total weekly dose of r-HuEPO (IU/ week) by 200.
Id- doża tal- bidu ta ’ Nespo ta 'kull ġimgħa (μg/ ġimgħa) tista ’ tiġi ddeterminata billi tiddividi d- doża totali fil- ġimgħa ta ’ r- HuEPO (IU/ ġimgħa) b ’ 200.
Because of
Id- doża tal- bidu ta ’ Nespo ta 'kull ġimgħatejn (μg/ ġimgħatejn) tista ’ tiġi ddeterminata billi tiddividi t- totali tad- dożi ta ’ r- HuEPO ta' perijodu ta 'ġimgħatejn b ’ 200.
3 individual variability, titration to optimal therapeutic doses is expected for individual patients.
Minħabba varjazzjonijiet minn pazjent għall- ieħor, l- aħjar doża terapewtika għandha tiġi mkejla għal kull pazjent
When substituting Nespo for r-HuEPO the haemoglobin should be monitored every one or two weeks and the same route of administration should be used.
Meta Nespo jiġi sostitwit b’ r- HuEPO, l- emoglobina għandha tiġi mmonitorjata kull ġimgħa jew ġimgħatejn u għandu jintuża l- istess mod ta ’ teħid.
Paediatric patients with chronic renal failure
riz Pazjenti tfal li għandhom insuffiċjenza renali kronika
Correction Phase
to Fażi ta ’ korrezzjoni
For patients ≥ 11 years of age, the initial dose by subcutaneous or intravenous administration is 0.45 µg/ kg body weight, as a single injection once weekly.
aw F 'pazjenti ta' ≤ 11- il sena, id- doża tal- bidu mogħtija taħt il- ġilda jew ġol- vina hija ta ’ 0. 45 μg/ kg piż tal- ġisem, bħala injezzjoni waħda darba fil- ġimgħa.
Alternatively, in patients not on dialysis, an initial dose of 0.75 μ g/ kg may be administered subcutaneously as a single injection once every two weeks.
Alternattivament, f 'pazjenti li mhux fuq dijalisi, doża tal- bidu ta' 0. 75 μg/ kg tista 'tingħata taħt il- ġilda bħala injezzjoni waħda darba kull ġimgħatejn.
If the increase in haemoglobin is inadequate (less than 1 g/ dl (0.6 mmol/ l) in four weeks)
x Jekk iż- żjieda fl- emoglobina mhix biżżejjed (inqas minn 1 g/ dl (0. 6 mmol/ l) f’ erba ’ ġimgħat), id- doża
ed increase the dose by approximately 25%.
du trid tiżdied b ’ bejn wieħed u ieħor 25%.
is If the rise in haemoglobin is greater than 2 g/ dl (1.25 mmol/ l) in four weeks reduce the dose by
ħa
or approximately 25%, depending on the rate of increase.
Jekk iż- żjieda fl- emoglobina tkun ta ’ aktar minn 2 g/ dl (1. 25 mmol/ l) f’ erba ’ ġimgħat, id- doża trid titnaqqas b ’ bejn wieħed u ieħor 25%, skond ir- rata taż- żjieda.
If the haemoglobin exceeds 12 g/ dl (7.5 mmol/ l), a dose reduction should be considered.
Jekk l- emoglobina taqbeż it- 12 g/ dl ’ g (7. 5 mmol/ l), tnaqqis fid- doża għandu jiġi kkunsidrat.
If the haemoglobin continues to increase,
Jekk il- livell ta ’ l- emoglobina jkompli jiżdied, id- doża għandha titnaqqas b’ bejn wieħed u ieħor 25%.
If after a dose reduction, haemoglobin continues
Jekk wara tnaqqis fid- doża, l- emoglobina im
au to increase, the dose should be temporarily withheld until the haemoglobin begins to decrease, at which point therapy should be reinitiated at approximately 25% lower than the previous dose.
tkompli tiżdied, id- doża għandha titwaqqaf temporanjament sa kemm l- emoglobina tibda tonqos, fl ’ liema punt il- kura għandha terġa tinbeda b’ doża ta ’ bejn wieħed u ieħor 25% anqas mid- doża ta ’ qabel. il
er The haemoglobin should be measured every one or two weeks until it is stable.
L- emoglobina għandha titkejjel kull ġimgħa jew ġimagħtejn sakemm tilħaq livell stabbli.
Maintenance Phase
Minn hemm al
For paediatric patients ≥ 11 years of age, in the maintenance phase, Nespo may continue to be ct
‘ il quddiem, l- emoglobina tista ’ titkejjel f ’ intervalli itwal. in
administered as a single injection once weekly or once every two weeks.
M' hemm l- ebda tmexxija dwar il- korrezzjoni ta 'l- emoglobina f' pazjenti tfal ta 'bejn sena u 10 snin. iċ
equivalent to twice the previous once weekly dose.
Fażi ta ’ manutenzjoni ed
In patients not on dialysis, once the target haemoglobin has been achieved with once every two week dosing, Nespo may be administered ro
F 'pazjenti tfal ta' ≤ 11- il sena, fil- fażi ta ’ manutenzjoni, Nespo jista 'jkompli jingħata bħala injezzjoni m
subcutaneously once monthly using an initial dose equal to twice the previous once every two week dose. lp
waħda darba fil- ġimgħa jew darba kull ġimgħatejn.
For pediatric patients 1-18 years of age, clinical data in paediatric patients has demonstrated that a
dijalisi, la darba t- targit tal- konċentrazzjoni ta’ emoglobina tkun ntlaħqet b 'iddożar ta' darba kull ġimgħatejn, Nespo jista 'jingħata darba fix- xahar bħala injezzjoni taħt il- ġilda b' doża tal- bidu od
patients receiving r-HuEPO two or three times weekly may be converted to once weekly Nespo, and in
ekwivalenti għal darbtejn id- doża li qabel kienet tingħata darba kull ġimgħatejn.
The initial ic
F 'pazjenti tfal bejn sena u 18- il sena, tagħrif kliniku wera li pazjenti tfal li jirċievu r- HuEPO darbtejn Pr
Because of individual variability, titration to ed
Id- doża tal- bidu f 'pazjenti tfal ta ’ Nespo ta' darba fil- ġimgħa jew ta 'darba kull ġimgħatejn (µg/ ġimgħa) tista' tiġi ddeterminata billi tiddividi d- doża totali ta 'ġimgħa ta' r- HuEPO (IU/ ġimgħa) b '240.
optimal therapeutic doses is expected for individual patients.
Minħabba varjazzjoni bejn individwu u ieħor, kalkoli għal dożi terapewtiċi ottimali għandhom jsiru għal pazjenti individwali.
When substituting Nespo for r-HuEPO the haemoglobin should be monitored every one or two weeks and the same route of administration M
Meta tibdel Nespo għal r- HuEPO l- emoglobina għandha tiġi mmonitorjata darba fil- ġimgħa jew darba kull ġimgħatejn u għandu jintuża l- istess mod ta ’ teħid.
Dosing should be titrated as necessary to maintain the haemoglobin target.
L - iddożar għandu jiġi kkalkulat skond il- bżonn biex jinżamm it- targit ta ’ emoglobina
If a dose adjustment is required to maintain haemoglobin at the desired level, it is recommended that the dose is adjusted by approximately 25%.
4 Jekk aġġustament fid- doża hija meħtieġa biex tinżamm l- emoglobina fil- livell mixtieq, huwa rrakkomandat li d- doża tiġi aġġustata b 'bejn wieħed u ieħor 25%.
If the rise in haemoglobin is greater than 2 g/ dl (1.25 mmol/ l) in four weeks reduce the dose by approximately 25%, depending on the rate of increase.
Jekk iż- żjieda fl- emoglobina tkun ta ’ aktar minn 2 g/ dl (1. 25 mmol/ l) f’ erba ’ ġimgħat, id- doża trid titnaqqas b 'bejn wieħed u ieħor 25%, skond ir- rata taż- żjieda.
If the haemoglobin continues to increase, the dose should be reduced by approximately 25%.
Jekk l- emoglobina tkompli tiżdied id - doża għandha tigi mnaqqsa bejn wieħed u ieħor b’ 25%.
If after a dose reduction, haemoglobin continues to
Jekk wara tnaqqis fid - doża il- livell ta ’ l - emoglobina jkompli jizdied, id- doża għandha titwaqqaf temporanjament sa kemm l- emoglobina tibda tonqos, fl ’ liema punt il- kura għandha terġa tinbeda b’ doża ta ’ bejn wieħed u ieħor 25% anqas mid -
4 increase, the dose should be temporarily withheld until the haemoglobin begins to decrease, at which point therapy should be reinitiated at approximately 25% lower than the previous dose.
Il- pazjenti għandhom jiġu mmonitorjati mill- qrib sa biex jiġi assigurat li tintuża l- anqas doża ta ’
Patients should be monitored closely to ensure that the lowest approved dose of Nespo is used to provide adequate control of the symptoms of anaemia.
riz Nespo approvata biex jiġi pprovdut kontroll fuq is- sintomi ta ’ l- anemija.
After any dose or schedule adjustment the haemoglobin should be monitored every one or two weeks.
to Wara kull aġġustament fid- doża jew fl- iskeda l- emoglobina trid tiġi mmonitorjata kull ġimgħa jew ġimgħatejn.
Dose changes in the maintenance phase of treatment should not be made more frequently than every two weeks.
Bidliet fid- doża waqt il- fażi ta ’ manutenzjoni tal- kura m’ għandhomx jsiru aktar spiss
When changing the route of administration the same dose must be used and the haemoglobin monitored every one or two weeks so that the appropriate dose adjustments can be made to keep the
Meta tibdel ir- rotta tal- amministrazzjoni, l- istess doża trid tiġi wżata u l- emoglobina trid tiġi
ed haemoglobin at the desired level.
x mmonitorjata kull ġimgħa jew ġimagħtejn ħalli l- aġġustamenti xierqa fid- doża jkunu jistgħu jsiru
is Treatment of symptomatic chemotherapy induced anaemia in cancer patients
du sabiex l- emoglobina tinżamm fil- livell mixtieq.
or Nespo should be administered by the subcutaneous route to patients with anaemia (e. g. haemoglobin concentration ≤ 10 g/ dl (6.2 mmol/ l)) in order to increase haemoglobin to not greater than 12 g/ dl
Kura ta ’ l- anemija sintomatika minħabba l- kimoterapija f’ pazjenti bil- kanċer ħa Nespo għandu jingħata taħt il- ġilda lil pazjenti b 'anemija (eżempju: konċentrazzjoni ta ’ emoglobina ’ g ≤10 g/ dl (6. 2 mmol/ l) sa biex l- emoglobina tiżdied b ’ mhux aktar minn 12g/ 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.
kollox; evalwazzjoni minn tabib ta ’ l- istat kliniku u l- kundizzjoni tal- pazjent hija neċessarja.
au Due to intra-patient variability, occasional individual haemoglobin values for a patient above and
Minħabba varjazzjonijiet bejn pazjent u ieħor, jistgħu okkażjonalment jiġu osservati f’ pazjenti valuri il
er below the desired haemoglobin level may be observed.
ta ’ l- emoglobina ‘ l fuq jew taħt il- livelli ta ’ emoglobina mixtieqa.
Haemoglobin variability should be addressed through dose management, with consideration for the haemoglobin target range of 10 g/ dl ng (6.2 mmol/ l) to 12 g/ dl (7.5 mmol/ l).
Varjazzjoni fl- emoglobina għandha tiġi ndirizzata permezz ta ’ immaniġjar tad- doża, b ’ kunsiderazzjoni għat- targit ta ’ l- emoglobina ta ’ al
A sustained haemoglobin level of greater than 12 g/ dl (7.5 mmol/ l) should be avoided; guidance for appropriate dose adjustments for when haemoglobin lo values exceeding 12 g/ dl (7.5 mmol/ l) are observed are described below. no
Livell ta ’ l- emoglobina miżmum fit- tul għal aktar minn in
The recommended initial dose is 500 μ g (6.75 μ g/ kg) given once every three weeks, or once weekly dosing can be given at 2.25 μ g/ kg body weight.
12 g/ dl (7. 5 mmol/ l) għandu jiġi evitat; tmexxija għall- aġġustament fid- doża xieraq għal meta l- valuri ta ’ l- emoglobina jaqbżu it- 12 g/ dl (7. 5 mmol/ l) huma murija hawn taħt. iċ
If the clinical response of the patient (fatigue, haemoglobin response) is inadequate after nine weeks, further therapy may not be effective. ct
Id- doża rakkomandata fil- bidu hija ta ’ 500 μg (6. 75 μg/ kg) mogħtija darba kull tliet ġimgħat, jew 2. 25 ed
Nespo therapy should be discontinued approximately four weeks after the end of chemotherapy. du
Jekk ir- rispons kliniku tal- pazjent (għeja, rispons ta 'l - emoglobina) mhux adegwat wara disa' ġimgħat, aktar kura tista 'ma tkunx effettiva. m
Once the therapeutic objective for an individual patient has been achieved, the dose should be reduced ro
Il- kura b 'Nespo għandha titwaqqaf bejn wieħed u ieħor erba' ġimgħat wara tmiem il- kimoterapija. t ot
Appropriate dose titration between lp
La darba li l- għan tal- kura għal pazjent individwali jkun ntlaħaq, id- doża trid titnaqqas għal bejn 25% u 50% tintuża l- anqas doża approvata ta ’ Nespo sabiex tinżamm l- emoglobina fl- livell li jikkontrolla s - od
500 μ g, 300 μ g, and 150 μ g should be considered. a
sintomi ta ’ l- anemija.
Patients should be monitored closely, if the haemoglobin exceeds 12 g/ dl (7.5 mmol/ l), the dose in
Pr
should be reduced by approximately 25 to 50%.
Il- pazjenti għandhom jiġu mmonitorjati mill- qrib, jekk l- emoglobina taqbeż it- 12g/ dl (7. 5mmol/ l), id - doża għandha titnaqqas b’ bejn wieħed u ieħor 25 u 50%.