qanastek/EMEA-V3 huggingface dataset:
ed Sodium phosphate monobasic, monohydrate Sodium phosphate dibasic, heptahydrate
to Sodium phosphate monobasic, monohydrate Sodium phosphate dibasic, heptahydrate
is Polysorbate 20
aw Polysorbate 20 Sodium chloride Water for injections
th 6.2 Incompatibilities
x 6. 2 Inkompatibilitajiet
au In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal
du 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
er products.
Sentejn
6.4 Special precautions for storage
6. 4 Prekawzjonijiet speċjali għall- ħażna il
Keep the syringes in the outer carton to protect from ct
Żomm is- siringi fil- kartuna ta ’ barra sabiex al
light. du
tipproteġihom mid- dawl. in
The revised expiry date for storage at below 25oC must not exceed the expiry date set in ro
Id- data ta ’ skadenza riveduta għal ħażna f’ temperatura ta ’ inqas minn 25oC ma tridx taqbeż id- data ta ’ skadenza stabbilita skond iż- żmien kemm ed
Following 5 days storage at below 25oC the pre-filled syringes must be discarded. lp
Wara 5 ijiem maħżuna f’ temperatura ta ’ inqas minn 25oC is- siringi mimlija għal - lest għandhom jintremew. m
6.5 Nature and contents of container a in
6. 5 In- natura tal- kontenitur u ta ’ dak li hemm ġo fih t ot
Prefilled Type I glass syringe with bromobutyl rubber stopper, 27 gauge stainless steel needle with 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.
Packs of 6 pre-filled syringes are available. ed
Pakketti ta ’ 6 siringi mimlija għal- lest huma disponibbli.
6.6 Special precautions for disposal of a used medicinal product or waste materials derived from M
6. 6 Prekawzjonijiet speċjali għar- rimi tal- prodott mediċinali mhux użat jew materjal ieħor għar - Pr
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.
40 Meta jingħata taħt il- ġilda, is- sit ta ’ injezzjoni għandu jinbidel ma ’ kull għotja.
The syringe is pre-assembled with a needle safety guard to prevent needle stick injury.
Dan ma jaffettwax l- operat normali tas- siringa u s- siringa tista ’ tiddawwar fit- tagħmir.
This does not
Agħti l- ammont meħtieġ.
When the injection has been administered the needle safety guard will cover the needle when releasing the plunger.
t za labra meta terħi l- planġer.
is or EU/ 1/ 02/ 211/ 010
NUMRU( I) TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ ħa EU/ 1/ 02/ 211/ 010 ’ g
18 March 2002
18 ta ’ Marzu, 2002 Data ta ’ l- aħħar tiġdid:
er Date of last renewal:
18 ta ’ Marzu, 2007 il al
DATE OF REVISION OF THE TEXT
DATA TA ’ META ĠIET RIVEDUTA L- KITBA in iċ
Dynepo 6,000 IU/ 0.3 ml solution for injection in a pre-filled syringe.
Dynepo 6, 000 IU/ 0. 3 ml soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest.
Pre-filled syringe containing 6,000 IU per 0.3 ml dose (20,000 IU/ ml) of the active substance epoetin delta.
Siringa mimlija għal- lest li fiha 46000 IU f’ kull doża ta ’ 0. 3 ml (20, 000 IU/ ml) tas- sustanza attiva epoetin delta.
is or Clear, colourless and waterlike.
Soluzzjoni ċara, bla kulur u qisha ilma.
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) ng in adult patients.
Dynepo hu indikat għall- kura ta ’ anemija sintomatika assoċjata ma ’ insuffiċjenza renali kronika (CRF) ħa f’ pazjenti adulti.
Starting dose is 50 IU/ kg three times a week if administered intravenously.
42 Immaniġġjar tad- Doża Id- doża tal- bidu hi ta ’ 50 IU/ kg tliet darbiet f’ ġimgħa jekk tingħata ġol- vina.
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.
Due to limited experience, the efficacy and safety of Dynepo could not be assessed in patients with impaired liver function.
Minħabba esperjenza limitata, l- effikaċja u s- sigurtà ta ’ Dynepo ma jistgħux ikunu evalwati f’ pazjenti t
43 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).
43 ngħataw mediċini li jistimulaw l- erythropoiesis (ESAs) biex jinkiseb livell ta ’ emoglobina ta ’ iktar minn 12 g/ dL (7. 5 mmol/ l).
• • Aluminium intoxication Haemoglobinopathies such as thalassaemia or sickle cell anaemia M
• Intossikazzjoni ta ’ l- aluminju • od
• • Vitamin deficiencies, i. e., folic acid or vitamin B12 deficiencies • Haemolysis • Malignant diseases including multiple myeloma and myelodysplastic syndrome • Malnutrition
Emoglobinopatiji bħal talessimja jew sickle cell anaemia • Defiċjenzi tal- vitamini, i. e., defiċjenzi tal- folic acid jew ta ’ vitamina B12 • Emolisi Pr
44 should also be determined once weekly until it has stabilised in the target range.
44 mira.
The use of Dynepo in nephrosclerotic patients not yet undergoing dialysis should be defined individually,
L- użu ta ’ Dynepo f’ pazjenti nefrosklerotiċi li għad mhux qed issirilhom id- dijaliżi, għandu jiġi definit
ed as a possible acceleration of progression of renal failure cannot be ruled out with certainty.
t za individwalment, għax il- possibbiltà ta ’ l- aċċelerazzjoni tal- progressjoni tal- kollass tal- kliewi ma tistax tiġi eskluża b’ ċertezza.
During haemodialysis, patients treated with Dynepo may require increased anticoagulation treatment
riz Matul l- emodijaliżi, il- pazjenti kkurati b’ Dynepo jista ’ jkollhom bżonn ta ’ żieda fil- kura kontra l - koagulazzjoni biex jiġi evitat it- tagħqid tad- demm tas- shunt arterjo- venuża.
or 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 -
th This may be associated with life-threatening cardiovascular complications.
Dan jista ’ jkun assoċjat ma ’ komplikazzjonijiet kardjovaskulari ta ’ periklu għall- ħajja.
No interactions have been reported during treatment with lo
x du L- ebda studji ma saru fuq interazzjoni ta` mediċini oħra ma` Dynepo
In case of its use during pregnancy, concomitant iron substitution should be considered in the ct
F’ każ ta ’ l- użu tagħha matul it- tqala, l- użu fl- istess ħin ta ’ il
Since many compounds du
Minħabba li ħafna al
are excreted in human milk, caution should be advised when Dynepo is administered to breast-feeding women. ro
komposti jitneħħew fil- ħalib uman, għandha tingħata attenzjoni meta Dynepo jingħata li nisa li jkunu in
4.7 Effects on ability to drive and use machines lp
4. 7 Effetti fuq is- sewqan u l- użu ta ’ magni ed
Dynepo has no or negligible influence on the ability to drive and use machines. a in
Dynepo m’ għandu l- ebda influwenza, jew influwenza negliġibbli, fuq il- ħila biex issuq jew tħaddem magni. m
4.8 Undesirable effects ic
4. 8 Effetti mhux mixtieqa t ot
The most ed
Esperjenza klinika od
Clinical experience with epoetins suggest hypertension and thrombosis risk may be reduced by titrating the dose to maintain M
Pr
46 When administration is halted, the eyrthropoietic parameters return toward baseline levels within the recovery period of 1-3 months.
46 jinnewtralizzaw, għal epoetin delta fil- bnedmin, ibbażati fuq ir- rispons kliniku.
discussed above may apply to this patient population is unclear, specifically considering that the dosages administered in the renal indication are lower than in the cancer indication. a in
Il- grad sa fejn ir- riżultati osservati fl- istudji kliniċi diskussi hawn fuq jistgħu japplikaw għal din il- popolazzjoni ta ’ pazjenti, m
47 5.3 Preclinical safety data
47 hi bejn 26% u 36%.
When given subcutaneously, the site of injection should be rotated with each administration.
48 Meta jingħata taħt il- ġilda, is- sit ta ’ injezzjoni għandu jinbidel ma ’ kull għotja.
When the injection 48 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 -
is EU/ 1/ 02/ 211/ 011
EU/ 1/ 02/ 211/ 011 ’ g
18 March 2002 Date of last renewal:
18 ta ’ Marzu 2002 Data ta ’ l- aħħar tiġdid:
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/. no 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 8,000 IU/ 0.4 ml solution for injection in a pre-filled syringe.
Dynepo 8, 000 IU/ 0. 4 ml soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest.
Pre-filled syringe containing 8,000 IU per 0.4 ml dose (20,000 IU/ ml) of the active substance epoetin delta.
Siringa mimlija għal- lest li fiha 8, 000 IU f’ kull doża ta ’ 0. 4 ml (20, 000 IU/ ml) tas- sustanza attiva epoetin delta.
Treatment with Dynepo should be initiated by physicians experienced in the treatment of anaemia associated with CRF. no
Il- kura b’ Dynepo għandha tinbeda minn tobba li għandhom esperjenza fil- kura ta ’ anemija assoċjata ma ’ CRF. il
50 Dose Management
50 IU/ kg darbtejn f’ ġimgħa jekk tingħata taħt il- ġilda.
51 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).
51 ngħataw mediċini li jistimulaw l- erythropoiesis (ESAs) biex jinkiseb livell ta ’ emoglobina ta ’ iktar minn 12 g/ dL (7. 5 mmol/ l).
Hypertension
Pressjoni għolja Il- biċċa l- kbira tal- pazjenti b’ kollass kroniku tal- kliewi għandhom storja medika ta ’ pressjoni għolja
Patients on Dynepo therapy
Pazjenti li jkunu fuq it- terapija Dynepo jista ’ jkollhom żieda fil- pressjoni tad- demm jew l -
ed can experience increase in blood pressure or aggravation of existing hypertension.
za aggravament ta ’ pressjoni tad- demm diġa ’ eżistenti.
Therefore, in patients treated with Dynepo, special care should be taken to monitor closely and control blood pressure.
Għalhekk, għandha tingħata attenzjoni speċjali lil pazjenti li jkunu kkurati b’ Dynepo, biex isir
is avoid acute complications like hypertensive encephalopathy and related complications (seizures,
Il- pressjoni tad- demm għandha tiġi 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).
or stroke).
Jekk dawn
Particular attention should be paid to sudden sharp migraine-like headaches as a possible
to ir- reazzjonijiet iseħħu, dawn ikollhom bżonn l- attenzjoni immedjata ta ’ tabib u kura medika intensiva.
au Increases in blood pressure may require treatment with anti-hypertensive medicines or dosing increase of existing anti-hypertensive medications.
aw Attenzjoni partikulari għandha tingħata lill- uġigħ ta ’ ras qisu emigranja, li jiġi għall- għarrieda, għax dan ikun possibbilment sinjal ta ’ twissija.
In addition, a reduction of the administered dose of Dynepo needs to be considered.
Flimkien ma ’ dan, tnaqqis tad- doża ta ’ Dynepo li
If blood pressure values remain high, a transient interruption of Dynepo therapy may be
Jekk il- valuri tal- pressjoni tad- demm jibqgħu għoljin, interruzzjoni
er required.
du temporanja tat- terapija b’ Dynepo tista ’ tkun meħtieġa.
Once hypertension is controlled with more intensified therapy, Dynepo therapy should be re-started at a ng reduced dose. lo
Ġaladarba l- pressjoni tad- demm għolja tkun ikkontrollata b’ terapija iktar intensiva, it- terapija b’ Dynepo ħa għandha tinbeda mill- ġdid b’ doża mnaqqsa.
This is the most common cause of an incomplete response to an erythropoietin therapy.
Din hi l- iktar kawża komuni ta ’ rispons inkomplet għat- terapija eritropojetika. im
Therefore, prior to and during Dynepo therapy, the patient's iron stores, including transferrin ct
Għalhekk, qabel u matul it- terapija b’ Dynepo, il- ħażna tal- ħadid tal- pazjent, li tinkludi s- saturazzjoni ta ’ transferrin u serum ferritin, għandha tiġi evalwata.
saturation and serum ferritin, should be evaluated.
Is- saturazzjoni ta ’ transferrin għandha tkun mill - inqas 20%, u dik ta ’ ferritin għandha tkun mill- inqas 100 ng/ ml.
Transferrin saturation should be at least 20%, and du
Jekk is- saturazzjoni ta ’ transferrin il
If transferrin saturation falls below 20%, or if ferritin falls below 100 ng/ ml, iron should be administered.
Eventwalment kważi l - al
erythropoiesis stimulated by Dynepo. lp
L- anemija f’ pazjenti li huma reżistenti jew iporisponsivi għal epoetin u ma jirrispondux għal 20, 000 iċ
Anaemia in epoetin-resistant or hyporesponsive patients with failure to respond to 20,000 IU/ week should be investigated, including referral to a haematologist. a
Dan għandu jinkludi li jiġu riferuti għand ematoloġista. ed
should be evaluated and treated, if appropriated: ic
• Infezzjoni/ infjammazzjoni • Telf moħbi ta ’ demm t
• Infection/ inflammation Occult blood loss ed
• Iperparatirojdiżmu/ Osteitis fibrosa cystica ot
• • Hyperparathyroidism/ Osteitis fibrosa cystica Aluminium intoxication M
• Intossikazzjoni ta ’ l- aluminju • 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
Emoglobinopatiji bħal talessimja jew sickle cell anaemia • Defiċjenzi tal- vitamini, i. e., defiċjenzi tal- folic acid jew ta ’ vitamina B12 • Emolisi Pr
52 The haemoglobin level should be determined once a week until it has stabilised in the suggested target range and the maintenance dose has been established.
52 mira.
4.5 Interaction with other medicinal products and other forms of interaction
4. 5 Interazzjoni ma prodotti oħra mediċinali u forom oħra ta` interazzjoni.
er ng No interaction studies have been performed.
x du L- ebda studji ma saru fuq interazzjoni ta` mediċini oħra ma` Dynepo
No interactions have been reported during treatment with Dynepo in the course of clinical trials. lo
L- ebda interazzjonijiet ma kienu rrappurtati matul il- kura b’ Dynepo sakemm damu jsiru l- provi ħa kliniċi. ’ g 4. 6 Tqala u treddigħ im
54 During the clinical trials, there were no indications of development of neutralising antibodies to epoetin delta in humans based on the clinical response.
54 jinnewtralizzaw, għal epoetin delta fil- bnedmin, ibbażati fuq ir- rispons kliniku.
The
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.
55 bioavailability of subcutaneously administered epoetin delta is between 26% and 36%.
Il- bijodisponibilità ta ’ epoetin delta mogħti taħt il- ġilda
5.3 Preclinical safety data
55 hi bejn 26% u 36%.
When given subcutaneously, the site of injection should be rotated with each administration.
56 Meta jingħata taħt il- ġilda, is- sit ta ’ injezzjoni għandu jinbidel ma ’ kull għotja.
56 Do not shake the syringe.
Iċċaqlaqx is- siringa.
ed Chineham, Basingstoke Hampshire, RG24 8EP United Kingdom
aw Chineham, Basingstoke Hampshire, RG24 8EP Renju Unit
is or 8.
x du 8.
th au EU/ 1/ 02/ 211/ 012
EU/ 1/ 02/ 211/ 012 ’ g
DATE OF FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION ng Date of first authorisation:
DATA TA ’ L- EWWEL AWTORIZZAZZJONI/ TIĠDID TA ’ L- AWTORIZZAZZJONI im
18 March 2007 lo no
18 ta ’ Marzu, 2007 il al
Detailed information on this medicinal product is available on the website of the European Medicines ct
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 10,000 IU/ 0.5 ml solution for injection in a pre-filled syringe.
Dynepo 10, 000 IU/ 0. 5 ml soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest.
Pre-filled syringe containing 10,000 IU per 0.5 ml dose (20,000 IU/ ml) of the active substance epoetin delta.
Siringa mimlija għal- lest li fiha 10, 000 IU f’ kull doża ta ’ 0. 5 ml (20, 000 IU/ ml) tas- sustanza attiva epoetin delta.
haemodialysis to avoid puncture of peripheral veins. in ic
għal mhux iktar minn 12 g/ dL (7. 5 mmol/ l).
Starting dose is 50 IU/ kg three times a week if administered intravenously.
58 Immaniġġjar tad- Doża Id- doża tal- bidu hi ta ’ 50 IU/ kg tliet darbiet f’ ġimgħa jekk tingħata ġol- vina.
59 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).
59 ngħataw mediċini li jistimulaw l- erythropoiesis (ESAs) biex jinkiseb livell ta ’ emoglobina ta ’ iktar minn 12 g/ dL (7. 5 mmol/ l).
In addition, a reduction of the administered dose of Dynepo needs
Flimkien ma ’ dan, tnaqqis tad- doża ta ’ Dynepo li
au to be considered.
x tingħata għandha tiġi kkunsidrata.
60 The haemoglobin level should be determined once a week until it has stabilised in the suggested target range and the maintenance dose has been established.
60 mira.
62 During the clinical trials, there were no indications of development of neutralising antibodies to epoetin delta in humans based on the clinical response.
62 jinnewtralizzaw, għal epoetin delta fil- bnedmin, ibbażati fuq ir- rispons kliniku.
63 5.3 Preclinical safety data
63 hi bejn 26% u 36%.
When given subcutaneously, the site of injection should be rotated with each administration.
64 Meta jingħata taħt il- ġilda, is- sit ta ’ injezzjoni għandu jinbidel ma ’ kull għotja.
64 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.
or EU/ 1/ 02/ 211/ 005
NUMRU( I) TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ ħa EU/ 1/ 02/ 211/ 005 ’ g
65 ed is or th au ANNEX II er ng A.
65 t za riz to aw x du
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND lo MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE no
MANIFATTURI TAS- SUSTANZA BIJOLOĠIKA ATTIVA U DETENTUR TA ’ L- AWTORIZZAZZJONI TAL - MANIFATTURA RESPONSABBLI GĦAT- TQEGĦID FIS - ’ g
B. lp a
SUQ im
CONDITIONS OF THE MARKETING AUTHORISATION ct du ro
KUNDIZZJONIJIET TA ’ L- AWTORIZZAZZJONI GĦALL - KUMMERĊ il al in iċ ed m t ot od Pr
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
MANIFATTUR TAS- SUSTANZA BIJOLOĠIKA ATTIVA U DETENTUR TA ’ L - AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦAT- TQEGĦID FIS- SUQ
Lonza Biologics, plc 228 Bath Road Slough Berkshire SL1 4DX United Kingdom
Lonza Biologics, plc 228 Bath Road Slough Berkshire SL1 4DX Renju Unit
ed Name and address of the manufacturer responsible for batch release
t za Isem u indirizz tal- manifattur responsabbli għall- ħruġ tal- lott
Shire Human Genetic Therapies AB
riz Shire Human Genetic Therapies AB Åldermansgatan 2
th Sweden
aw Svezja.
au B.
x B.
• er CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON ng THE MARKETING AUTHORISATION HOLDER lo Medicinal product subject to restricted medical prescription (See Annex I:
du • KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FUQ IL- FORNIMENT U L- UŻU ħa IMPOSTI FUQ ID- DETENTUR TA` L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS - SUQ ’ g
• CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT ct
Sommarju tal- Karatteristiċi tal - im
Not applicable du
Prodott, sezzjoni 4. 2).
• OTHER CONDITIONS ro
• KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FIR- RIGWARD TA ’ L- UŻU il
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in lp
MINGĦAJR PERIKLU U EFFETTIV TAL- PRODOTT MEDIĊINALI al
the Pharmacovigilance Plan. a
Ma jgħoddx f’ dan il- każ. in
An updated Risk Management Plan should be provided as per CHMP Guideline on Risk Management in
• OTHER iċ
Systems for medicinal products for human use except that routine updates of the Risk Management ic
Id- Detentur ta ’ l- Awtorizzazzjoni tal- Manifattura jwiegħed li jkun obbligat li jwettaq l- istudji u ed
Plan should be provided yearly until the start of the three-yearly PSUR cycle. ed M
attivitajiet ta ’ farmako- viġilanza addizzjonali deskritti fil- pjan tal- Farmakoviġilanza. m t ot od Pr
67 ed is or th au ANNEX III er ng LABELLING AND PACKAGE LEAFLET lo no ct du ro lp a in ic ed M
67 t za riz to aw x du ANNESS III ħa TIKKETTA U FULJETT TA ’ TAGĦRIF ’ g im il al in iċ ed m t ot od Pr
68 M ed ic in alp ro du ct
68 Pr od ot
69 no A.
69 im A.
LABELLING lo ng er au th or is ed PARTICULARS TO APPEAR ON THE OUTER PACKAGING
TIKKETTA ’ g ħa du x aw to riz za t TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Dynepo 1,000 IU/ 0.5 ml solution for injection in a prefilled syringe Epoetin delta
Dynepo 1, 000 IU/ 0. 5 ml soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest
ed 2.
za riz 2.
is Pre-filled syringe containing 1,000 IU per 0.5 ml dose (2,000 IU/ ml) of the active substance epoetin
to 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.
th 3.
aw 3.
au Excipients: sodium phosphate monobasic monohydrate, sodium phosphate dibasic heptahydrate,
x Sustanzi mhux attivi: sodium phosphate monobasic monohydrate, sodium phosphate dibasic heptahydrate, sodium chloride, polysorbate 20 u ilma għal injezzjonijiet.
er sodium chloride, polysorbate 20 and water for injections. ng 4.
du 4.
Solution for injection, 0.5ml of epoetin delta in a pre-filled syringe: pack size of 6 no
GĦAMLA FARMAĊEWTIKA U KONTENUT ħa Soluzzjoni għall- injezzjoni, 0. 5ml ta ’ epoetin delta f’ siringa mimlija għal- lest: daqs tal- pakkett ta ’ 6 ’ g im
METHOD AND, IF NECESSARY, ROUTE(S) OF ADMINISTRATION ct du
MOD TA ’ KIF U MNEJN JINGHATA
Intravenous or subcutaneous use. ro
Użu għal ġol- vini jew taħt il- ġilda. il al
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT lp
TWISSIJA SPEĊJALI LI L- PRODOTT MEDIĊINALI GĦANDU JINŻAMM FEJN MA in
OF THE REACH AND SIGHT OF CHILDREN a
JINTLAĦAQX U MA JIDHIRX MIT- TFAL iċ
Keep out of the reach and sight of children. in ic
Żomm fejn ma jintlaħaqx u ma jidhirx mit- tfal. ed
OTHER SPECIAL WARNING(S), IF NECESSARY ed
TWISSIJA/ IET SPEĊJALI OĦRA, JEKK MEĦTIEĠA m
Use only clear and colourless solutions.
Uża biss soluzzjonijiet ċari u bla kulur.
M
Aqra l- fuljett ta ’ tagħrif qabel l- użu. t ot od
EXP
JIS Pr
Store in a refrigerator (2oC – 8oC) Do not freeze.
Aħżen fi friġġ (2oC – 8oC) Tagħmlux fil- friża.
Keep syringes in the outer carton to protect from light.
Żomm is- siringi fil- kartuna ta ’ barra sabiex tipproteġi mid- dawl.
Do not use any remaining liquid.
Tuża l- ebda likwidu li jkun fadal.
or Shire Pharmaceutical Contracts Ltd
t za Shire Pharmaceutical Contracts Ltd Hampshire International Business Park
th Hampshire International Business Park Chineham, Basingstoke
riz Chineham, Basingstoke Hampshire, RG24 8EP Renju Unit
au Hampshire, RG24 8EP United Kingdom
NUMRU( I) TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
LOT du
x du 13.
GENERAL CLASSIFICATION FOR SUPPLY ro lp
KLASSIFIKAZZJONI ĠENERALI TA ’ KIF JINGĦATA
Medicinal product subject to medical prescription. a in
Prodott mediċinali jingħata bir- riċetta tat- tabib. il al
INSTRUCTIONS ON USE ic ed
STRUZZJONIJIET DWAR L- UŻU in iċ
INFORMATION IN BRAILLE M
INFORMAZZJONI BIL- BRAILLE ed
Dynepo 1000
Dynepo 1000 m t ot od Pr
71 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
71 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW STRIXXI
Dynepo 1,000 IU/ 0.5ml Injection Epoetin delta
Dynepo 1, 000 IU/ 0. 5ml
NAME OF THE MARKETING AUTHORISATION HOLDER
ISEM TAD- DETENTUR TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS - SUQ
or th 3.
aw 3.
au EXP
x JIS
4.
du 4.
BATCH NUMBER er ng Lot lo no
NUMRU TAL- LOTT
in
OĦRAJN
lp
im il al in iċ ed m t ot od Pr
72 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
72 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
SYRINGE LABEL
TIKKETTA TAS- SIRINGA
Dynepo 1,000 IU/ 0.5 ml injection Epoetin delta
Dynepo 1, 000 IU/ 0. 5 ml
ed IV/ SC
t injezzjoni
is or 2.
riz to 2.
er ng 4.
du ħa 4.
BATCH NUMBER lo
NUMRU TAL- LOTT ’ g LOTT im
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT ct
IL- KONTENUT SKOND IL- PIŻ, VOLUM, JEW INDIVIDWALI il
0.5 ml (2,000 IU/ ml) du ro
0. 5 ml (2, 000 IU/ ml) al in
OTHER ed M
OĦRAJN iċ ed m t ot od Pr
73 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
73 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Dynepo 2,000 IU/ 0.5 ml solution for injection in a prefilled syringe Epoetin delta
Dynepo 2, 000 IU/ 0. 5 ml soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest Epoetin delta
ed 2.
t za 2.
is Pre-filled syringe containing 2,000 IU per 0.5 ml dose (4,000 IU/ ml) of the active substance epoetin delta.
riz Siringa mimlija għal- lest li fiha 2, 000 IU f’ kull doża ta ’ 0. 5 ml (4, 000 IU/ ml) tas- sustanza attiva
au Excipients: sodium phosphate monobasic monohydrate, sodium phosphate dibasic heptahydrate, sodium chloride, polysorbate 20 and water for injections.
x heptahydrate, sodium chloride, polysorbate 20 u ilma għal injezzjonijiet.
er ng 4.
du 4.
PHARMACEUTICAL FORM AND CONTENTS lo
GĦAMLA FARMAĊEWTIKA U KONTENUT
Solution for injection, 0.5ml of epoetin delta in a pre-filled syringe: pack size of 6 no
Soluzzjoni għall- injezzjoni, 0. 5ml ta ’ epoetin delta f’ siringa mimlija għal- lest: daqs tal- pakkett ta ’ 6 ’ g
METHOD AND, IF NECESSARY, ROUTE(S) OF ADMINISTRATION ct
MOD TA ’ KIF U MNEJN JINGHATA im
Intravenous or subcutaneous use. du ro
Użu għal ġol- vini jew taħt il- ġilda. il al
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN lp
TWISSIJA SPEĊJALI LI L- PRODOTT MEDIĊINALI GĦANDU JINŻAMM FEJN MA JINTLAĦAQX U MA JIDHIRX MIT- TFAL in
Keep out of the reach and sight of children. a in
Żomm fejn ma jintlaħaqx u ma jidhirx mit- tfal. iċ ed
OTHER SPECIAL WARNING(S), IF NECESSARY ic ed
TWISSIJA/ IET SPEĊJALI OĦRA, JEKK MEĦTIEĠA m
M
Aqra l- fuljett ta ’ tagħrif qabel l- użu. t ot
EXPIRY DATE
DATA TA ’ META JISKADI od
Dynepo 2000
Dynepo 2000 m t ot od Pr
75 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
75 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW STRIXXI
Dynepo 2,000 IU/ 0.5ml Injection Epoetin delta
Dynepo 2, 000 IU/ 0. 5ml
76 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
76 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Dynepo 2,000 IU/ 0.5 ml injection Epoetin delta
Dynepo 2, 000 IU/ 0. 5 ml
0.5 ml (4,000 IU/ ml) du ro
0. 5 ml (4, 000 IU/ ml) al in
77 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
77 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Dynepo 3,000 IU/ 0.3 ml solution for injection in a prefilled syringe Epoetin delta
Dynepo 3, 000 IU/ 0. 3 ml soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest Epoetin delta
is Pre-filled syringe containing 3,000 IU per 0.3 ml dose (10,000 IU/ ml) of the active substance epoetin delta.
riz Siringa mimlija għal- lest li fiha 3, 000 IU f’ kull doża ta ’ 0. 3 ml (10, 000 IU/ ml) tas- sustanza attiva
Solution for injection, 0.3ml of epoetin delta in a pre-filled syringe: pack size of 6 no
Soluzzjoni għall- injezzjoni, 0. 3ml ta ’ epoetin delta f’ siringa mimlija għal- lest: daqs tal- pakkett ta ’ 6 ’ g
Dynepo 3000
Dynepo 3000 m t ot od Pr
79 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
79 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW STRIXXI
Dynepo 3,000 IU/ 0.3ml Injection Epoetin delta
Dynepo 3, 000 IU/ 0. 3ml
Dynepo 3,000 IU/ 0.3 ml injection Epoetin delta
Dynepo 3, 000 IU/ 0. 3 ml
0.3 ml. (10,000 IU/ ml) du ro
0. 3 ml (10, 000 IU/ ml) al in
81 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
81 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Dynepo 4,000 IU/ 0.4 ml solution for injection in a prefilled syringe Epoetin delta
Dynepo 4, 000 IU/ 0. 4 ml soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest Epoetin delta
is Pre-filled syringe containing 4,000 IU per 0.4 ml dose (10,000 IU/ ml) of the active substance epoetin delta.
riz Siringa mimlija għal- lest li fiha 4, 000 IU f’ kull doża ta ’ 0. 4 ml (10, 000 IU/ ml) tas- sustanza attiva
Solution for injection, 0.4ml of epoetin delta in a pre-filled syringe: pack size of 6 no
Soluzzjoni għall- injezzjoni, 0. 4ml ta ’ epoetin delta f’ siringa mimlija għal- lest: daqs tal- pakkett ta ’ 6 ’ g
Dynepo 4000
Dynepo 4000 m t ot od Pr
83 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
83 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW STRIXXI
Dynepo 4,000 IU/ 0.4ml Injection Epoetin delta
Dynepo 4, 000 IU/ 0. 4ml
84 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
84 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Dynepo 4,000 IU/ 0.4 ml injection Epoetin delta
Dynepo 4, 000 IU/ 0. 4 ml
0.4 ml. (10,000 IU/ ml°) du ro
0. 4 ml (10, 000 IU/ ml) al in
85 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
85 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Dynepo 5,000 IU/ 0.5 ml solution for injection in a prefilled syringe Epoetin delta
Dynepo 5, 000 IU/ 0. 5 ml soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest Epoetin delta
2.
t za 2.
ed Pre-filled syringe containing 5,000 IU per 0.5 ml dose (10,000 IU/ ml) of the active substance epoetin
riz Siringa mimlija għal- lest li fiha 5, 000 IU f’ kull doża ta ’ 0. 5 ml (10, 000 IU/ ml) tas- sustanza attiva
is delta
to epoetin delta.
Dynepo 5000
Dynepo 5000 m t ot od Pr
87 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
87 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW STRIXXI
Dynepo 5,000 IU/ 0.5ml Injection Epoetin delta
Dynepo 5, 000 IU/ 0. 5ml
ed is 2.
riz 2.
th au 3.
aw 3.
EXP
x JIS
er ng 4.
Lott
BATCH NUMBER lo
NUMRU TAL- LOTT
Lot no
’ g
88 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
88 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Dynepo 5,000 IU/ 0.5 ml injection Epoetin delta
Dynepo 5, 000 IU/ 0. 5 ml
0.5 ml (10,000 IU/ ml) du ro
0. 5 ml (10, 000 IU/ ml) al in
89 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
89 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Dynepo 6,000 IU/ 0.3 ml solution for injection in a prefilled syringe Epoetin delta
Dynepo 6, 000 IU/ 0. 3 ml soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest Epoetin delta
is Pre-filled syringe containing 6,000 IU per 0.3 ml dose (20,000 IU/ ml) of the active substance epoetin
riz Siringa mimlija għal- lest li fiha 6, 000 IU f’ kull doża ta ’ 0. 3 ml (20, 000 IU/ ml) tas- sustanza attiva
or delta.
to epoetin delta.
au Excipients: sodium phosphate monobasic monohydrate, sodium phosphate dibasic heptahydrate,
Sustanzi mhux attivi: sodium phosphate monobasic monohydrate, sodium phosphate dibasic
er sodium chloride, polysorbate 20 and water for injections. ng 4.
x heptahydrate, sodium chloride, polysorbate 20 u ilma għal injezzjonijiet.
METHOD AND, IF NECESSARY, ROUTE(S) OF ADMINISTRATION ct du
MOD TA ’ KIF U MNEJN JINGHATA im
OF THE REACH AND SIGHT OF CHILDREN a
TWISSIJA SPEĊJALI LI L- PRODOTT MEDIĊINALI GĦANDU JINŻAMM FEJN MA JINTLAĦAQX U MA JIDHIRX MIT- TFAL in
Keep out of the reach and sight of children. in ic
Żomm fejn ma jintlaħaqx u ma jidhirx mit- tfal. iċ ed
Dynepo 6000
Dynepo 6000 m t ot od Pr
91 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
91 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW STRIXXI
BLISTER
FOLJI
Dynepo 6,000 IU/ 0.3ml Injection Epoetin delta
za Epoetin delta
92 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
92 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Dynepo 6,000 IU/ 0.3 ml injection Epoetin delta
Dynepo 6, 000 IU/ 0. 3 ml
0.3 ml (20,000 IU/ ml) du ro
0. 3 ml (20, 000 IU/ ml) al in
93 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
93 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Dynepo 8,000 IU/ 0.4 ml solution for injection in a prefilled syringe Epoetin delta
Dynepo 8, 000 IU/ 0. 4 ml soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest Epoetin delta
is Pre-filled syringe containing 8,000 IU per 0.4 ml dose (20,000 IU/ ml) of the active substance epoetin
riz Siringa mimlija għal- lest li fiha 8, 000 IU f’ kull doża ta ’ 0. 4 ml (20, 000 IU/ ml) tas- sustanza attiva
Dynepo 8000
Dynepo 8000 m t ot od Pr
95 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
95 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW STRIXXI
Dynepo 8,000 IU/ 0.4ml Injection Epoetin delta
za Epoetin delta
96 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
96 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Dynepo 8,000 IU/ 0.4 ml injection Epoetin delta
Dynepo 8, 000 IU/ 0. 4 ml
0.4 ml (20,000 IU/ ml) du ro
0. 4 ml (20, 000 IU/ ml) al in
97 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
97 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Dynepo 10,000 IU/ 0.5 ml solution for injection in a prefilled syringe Epoetin delta
Dynepo 10, 000 IU/ 0. 5 ml soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest Epoetin delta
is Pre-filled syringe containing 10,000 IU per 0.5 ml dose (20,000 IU/ ml) of the active substance epoetin
riz Siringa mimlija għal- lest li fiha 10, 000 IU f’ kull doża ta ’ 0. 5 ml (20, 000 IU/ ml) tas- sustanza attiva
Dynepo 10000
Dynepo 10000 m t ot od Pr
99 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
99 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW STRIXXI
Dynepo 10,000 IU/ 0.5ml Injection Epoetin delta
Dynepo 10, 000 IU/ 0. 5ml
100 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
100 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Dynepo 10,000 IU/ 0.5 ml injection Epoetin delta
Dynepo 10, 000 IU/ 0. 5 ml
0.5 ml (20,000 IU/ ml) du ro
0. 5 ml (20, 000 IU/ ml) al in
ic
101 Pr od ot
in
t
a
m ed
lp
iċ in al
101 M ed ic in alp ro du ct
il
102 no lo B.
102 im ’ g B.
PACKAGE LEAFLET ng er au th or is ed PACKAGE LEAFLET – INFORMATION FOR THE USER
TAGĦRIF GĦAL MIN QED JAGĦMEL UŻU MINNHA
Dynepo 1,000 IU/ 0.5 ml solution for injection in a pre-filled syringe Dynepo 2,000 IU/ 0.5ml solution for injection in a pre-filled syringe Dynepo 3,000 IU/ 0.3ml solution for injection in a pre-filled syringe Dynepo 4,000 IU/ 0.4ml solution for injection in a pre-filled syringe Dynepo 5,000 IU/ 0.5 ml solution for injection in a pre-filled syringe Dynepo 6,000 IU/ 0.3 ml solution for injection in a pre-filled syringe Dynepo 8,000 IU/ 0.4 ml solution for injection in a pre-filled syringe Dynepo 10,000 IU/ 0.5ml solution for injection in a pre-filled syringe Epoetin delta
Dynepo 1, 000 IU/ 0. 5 ml soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest Dynepo 2, 000 IU/ 0. 5 ml soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest Dynepo 3, 000 IU/ 0. 3 ml soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest Dynepo 4, 000 IU/ 0. 4 ml soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest Dynepo 5, 000 IU/ 0. 5 ml soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest Dynepo 6, 000 IU/ 0. 3 ml soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest Dynepo 8, 000 IU/ 0. 4 ml soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest
ed Read all of this leaflet carefully before you start taking this medicine.
riz Aqra dan il- fuljett kollu qabel tibda tużu din il- mediċina.
is
aw
or if their symptoms are the same as yours.
anki jekk ikollhom l- istess sintomi bħal tiegħek.
th please tell your doctor or pharmacist.
x imsemmijin f’ dan il- fuljett, jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek.
au In this leaflet:
du F’ dan il- fuljett:
er 2.
X’ inhu Dynepo u għalxiex jintuża ħa 2.
Before you take Dynepo 3.
Qabel ma tuża Dynepo 3.
How to take Dynepo ng 4.
Kif għandek tuża Dynepo 4.
How to store Dynepo lo
Kif għandek tahżen Dynepo im
Further information no
Aktar tagħrif il
WHAT DYNEPO IS AND WHAT IT IS USED FOR ct
X’ INHU DYNEPO U GĦALXIEX JINTUŻA al
Epoetin delta is a human erythropoietin made by a technology process called gene-activation, which uses a human cell line. du
Epoetin delta hu erythropoietin uman magħmul minn proċess tat- teknoloġija msejjaħ attivazzjoni tal - ġeni, li juża linja ta ’ ċelluli umani. in
Epoetin delta is a hormone which stimulates the production of red blood cells in the bone marrow.
Epoetin delta hu ormon li jistimula l- produzzjoni taċ- ċelluli ħomor tad- demm fl- għadma tal- mudullun. iċ
your body. lp
Iċ- ċelluli ħomor tad- demm huma importanti ħafna għax fihom l- emoglobina, proteina li tqassam l - ossiġnu f’ ġismek. ed
Dynepo is used for treating the symptoms of anaemia (which include tiredness, weakness and shortness of breath) associated with chronic renal failure in adult patients, Anaemia is a blood disorder characterised by a
Dynepo jintuża biex jikkura s- sintomi ta ’ anemija (li jinkludu għeja, dgħjufija u qtugħ ta ’ nifs) marbuta m
a decrease in red blood cells.
ma ’ insuffiċjenza kronika renali f’ pazjenti adulti.
Dynepo may be used in patients on dialysis (a blood clearance technique) or in
L- anemija hi marda tad- demm ikkaratterizzata minn tnaqqis taċ- ċelluli ħomor tad- demm, f’ pazjenti b’ kollass kroniku tal- kliewi.
in patients not on dialysis. ic ed
Dynepo jista ’ jintuża f’ pazjenti li huma fuq id- dijaliżi (teknika tat- tisfija tad- demm) jew f’ pazjenti li mhumiex fuq id- dijaliżi. t ot od
BEFORE YOU TAKE DYNEPO M
QABEL MA ’ TUŻA DYNEPO
Do not take Dynepo:
Tużax Dynepo Pr
- if you are allergic (hypersensitive) to epoetin delta or any of the other ingredients of Dynepo.
- jekk inti allerġiku/ a (għandek sensittività eċċessiva) għal epoetin delta jew ghal xi sustanzi l -
- if you have difficulties controlling your blood pressure.
- jekk għandek problema biex tikkontrolla l- pressjoni tad- demm tiegħek.
Your doctor will closely monitor your haemoglobin concentration level to keep it within the target range of 10 to 12 g/ dl and may therefore need to change your dosage of Dynepo accordingly.
Oqgħod attent ħafna b’ Dynepo It- tabib tiegħek ser jimmonitorja l- livell tal- konċentrazzjoni ta ’ l- emoglobina tiegħek mill- qrib biex iżommha fil- medda tal- mira ta ’ 10 sa 12 g/ dl u, għalhekk, jista ’ jkollu bżonn li jibdel id- dożaġġ tiegħek ta ’ Dynepo kif ikun xieraq.
Occasionally, your individual haemoglobin values may be above and below this recommended target level.
Kultant, il- livelli individwali ta ’ l- emoglobina tiegħek jistgħu jkunu taħt u fuq dan il- livell rakkomandat tal- mira.
Your doctor will manage your dosage so that haemoglobin concentrations will not consistently be above 12 g/ dl which may be associated with a higher risk of cardiovascular events (e. g. heart attacks).
103 b’ tali mod li l- konċentrazzjonijiet ta ’ l- emoglobina ma jkunux iktar minn 12 g/ dl b’ mod konsistenti, li jista ’ jkun assoċjat ma ’ riskju ogħla ta ’ avvenimenti kardjovaskulari (eż. attakki tal- qalb).
103 Your blood pressure needs to be checked closely before and during treatment with Dynepo.
Il- pressjoni tad- demm tiegħek jeħtieġ li tkun iċċekkjata bir- reqqa qabel u matul il- kura b’ Dynepo.
If your blood pressure rises, your doctor may give you medicines to reduce your blood pressure or increase the dosage of your existing blood pressure lowering medication.
Jekk il - pressjoni tad- demm tiegħek titla ’, it- tabib tiegħek jista ’ jagħtik mediċini biex inaqqas il- pressjoni tad - demm tiegħek jew iżid id- dożaġġ tal- mediċina li qed tieħu biex tbaxxi il- pressjoni tad- demm.
It may also be necessary to reduce your dose of Dynepo or to stop the treatment for a short period of time.
Jista ’ jkun ukoll meħtieġ li jnaqqaslek id- doża tiegħek ta ’ Dynepo jew iwaqqaflek il- kura għal perjodu qasir ta ’ żmien.
If you have severe headache, stabbing migraine-like headaches or fits, you should see your doctor at once.
Jekk ikollok uġigħ ta ’ ras qawwi, uġigħ ta ’ ras qisu daqqiet ta ’ stallett bħal dak ta ’ l- emigranja jew
It could be a consequence of a marked rise in your blood pressure.
Dawn jistgħu jkunu konsegwenza ta ’ żieda qawwija fil- pressjoni tad- demm tiegħek.
Your doctor will measure your blood iron level during treatment with Dynepo and may give you iron supplements.
riz It- tabib tiegħek ser ikejjel il- livell tal- ħadid fid- demm tiegħek matul il- kura b’ Dynepo u jista ’ jagħtik supplimenti tal- ħadid.
Your doctor will monitor the different chemical levels in your blood including: creatinine, potassium.
to It- tabib tiegħek ser jimmonitorja l- livelli kimiċi differenti fid- demm tiegħek li jinkludu: kreatinina,
ed During dialysis, an increase in the dose of the anticoagulation treatment is frequently required since the increased number of red blood cells may cause blocking of the dialysis tubes.
Matul id- dijaliżi, żieda fid- doża tal- kura kontra l- koagulazzjoni ta ’ spiss tkun meħtieġa, minħabba li ż -
is or Dynepo may not be suitable for patients under 18 years old, or for patients with renal or liver problems.
x żieda fin- numru ta ’ ċelluli ħomor tad- demm tista ’ tikkawża imblokk fit- tubi tad- dijaliżi.
th Dynepo should not be used by healthy persons.
du Dynepo jista ’ ma jkunx adattat għal pazjenti taħt it- 18- il sena, jew għal pazjenti bi problemi tal- kliewi jew problemi tal- fwied. ħa Dynepo m’ għandux jintuża minn nies f’ saħħithom.
Severe reactions, possibly fatal, involving the heart and
Reazzjonijiet severa, possibbilment fatali, li jinvolvu ’ g l- qalb u l- vini jew arterji, jistgħu jseħħu. im
au blood vessels may occur.
Dynepo mhuwiex approvat għall- użu f’ pazjenti li għandhom il- kanċer.
Taking other medicines
Meta tieħu mediċini oħra il
Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, lo even those not prescribed.
Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew dan l- aħħar ħadt xi mediċini oħra, anki dawk mingħajr riċetta. al
However, so far, no interactions with other medicines have been reported during treatment with no
Madankollu, s’ issa, l- ebda interazzjonijiet ma ’ mediċini oħrajn ma kienu rrappurtati matul il- kura b’ Dynepo. in iċ
Taking Dynepo with food and drink ct
Meta tuża Dynepo ma ’ l- ikel u max- xorb L- ikel u x- xorb m’ għandhom l- ebda influwenza fuq Dynepo. ed
Food and drink has no influence on Dynepo. du
Tqala u treddigħ m
Pregnancy and breast-feeding Inform your doctor if you are pregnant or breast-feeding or think you might be pregnant. ro
Informa lit- tabib tiegħek jekk inti tqila, jekk qed tredda ’ jew jekk taħseb li tista ’ tkun tqila.
Your doctor will consider what is the best treatment for you during your pregnancy. lp
It- tabib tiegħek ser jikkunsidra liema hi l- aħjar kura għalik matul it- tqala. t ot
Driving and using machines No effects on ability to drive and use machines have been observed. a in
Sewqan u tħaddim ta ’ magni L- ebda effetti fuq il- ħila biex issuq jew l- użu ta` magni ma kienu osservati. od
HOW TO TAKE DYNEPO ed
KIF GĦANDEK TUŻA DYNEPO Pr
Your doctor will be experienced in the treatment of renal failure and the use of erythropoietin.
It- tabib tiegħek ser ikollu esperjenza fil- kura ta ’ kollass tal- kliewi u l- użu ta ’ erythropoietin.
M
L- ewwel doża tiegħek ser tingħata taħt superviżjoni medika, għax għalkemm rari jista` jkun hemm allerġija.
Dynepo may be administered intravenously (into a vein) or subcutaneously (under the skin).
Dynepo jista ’ jingħata ġol- vina jew taħt il- ġilda.
In patients not on haemodialysis, where intravenous access is not readily available, Dynepo is usually given subcutaneously.
F’ pazjenti li mhumiex fuq l- emodijalisi, fejn l- aċċess ġol- vini ma jkunx disponibbli fil- pront, Dynepo normalmen jingħata taħt il- ġilda.
When given subcutaneously, the site of injection should be changed with each injection.
Meta jingħata taħt il- ġilda, is- sit ta ’ injezzjoni għandu jinbidel għal kull għotja.
Your dose of Dynepo will be determined by your doctor and will be adjusted individually according to your personal needs.
104 Id- doża tiegħek ta ’ Dynepo tkun stabbilita mit- tabib tiegħek u din tkun aġġustata individwalment skond il- ħtiġijiet personali tiegħek.
Your doctor should maintain your haemoglobin level within the target range of 10 to 12 g/ dl.
It- tabib tiegħek għandu jżomm il- livell ta ’ l- emoglobina tiegħek fil- medda tal- mira ta ’ 10 sa 12 g/ dl.
Occasionally, your individual haemoglobin values may be below and above this recommended target level.
Kultant, il- livelli individwali ta ’ l- emoglobina tiegħek jistgħu jkunu taħt u fuq dan il- livell rakkomandat tal- mira.
You will be monitored
Madankollu, il- livell ta ’ l- emoglobina tiegħek m’ għandux jaqbeż 12 g/ dl b’ mod konsistenti.
104 closely to ensure the lowest dose of Dynepo is used to provide adequate control of your symptoms of anaemia.
Int ser tkun immonitorjat mill- qrib biex ikun żgurat li tintuża l- inqas doża ta ’ Dynepo biex tipprovdi kontroll adegwat tas- sintomi ta ’ l- anemija.
Always take Dynepo exactly as your doctor has told you to.
Dejjem għandek tuża Dynepo skond il- parir tat- tabib.
You should check with your doctor or pharmacist if you are not sure.
t za ma ’ l- ispiżjar jekk ikollok xi dubju.
The usual starting dose is 50 IU/ kg three times a week if administered intravenously or 50 IU/ kg twice a week if administered subcutaneously.
Id- doża normali tal- bidu hi ta ’ 50 IU/ kg tliet darbiet f’ ġimgħa jekk tingħata ġol- vina jew 50 IU/ kg
The maintenance dose will be then decided by your doctor to maintain the level of your haemoglobin within the target range.
to Id- doża tal- manutenzjoni mbagħad ser tkun deċiża mit- tabib tiegħek biex iżżomm il- livell ta ’ l - emoglobina tiegħek fil- medda tal- mira.
ed Mainly because of the time required for the production of new red blood cells, an interval of approximately 4 weeks may occur between the dose and an improvement in your anaemia.
aw L- aktar minħabba ż- żmien meħtieġ għall- produzzjoni ta ’ ċelluli ħomor tad- demm ġodda, intervall ta ’ madwar 4 ġimgħat jista ’ jgħaddi bejn meta tieħu d- doża u titjib fl- anemija tiegħek.
Your doctor will probably not make changes to your dosage more than once a month.
It- tabib tiegħek
is After any change to the dose, you will have frequent blood tests (once a week) until your haemoglobin
Wara kwalunkwe tibdil tad- doża, inti ser ikollok testijiet frekwenti tad- demm (darba f’ ġimgħa)
or level reaches the target range.
du sakemm il- livell ta ’ l- emoglobina tiegħek jilħaq il- medda tal- mira.
Your haemoglobin level should then be controlled at regular intervals.
Il- livelli ta ’ l- emoglobina tiegħek għandhom imbagħad ikunu mmonitorjati f’ intervalli regolari. ħa It- terapija b’ Dynepo hi normalment kura fit- tul. ’ g
th Dynepo therapy is usually a long-term treatment.
Jekk tieħu aktar Dynepo milli suppost im
au If you take more Dynepo than you should Dynepo can be given in a very large range of doses.
Dynepo jista ’ jingħata f’ medda kbira ħafna ta ’ dożi.
If you accidentally give yourself too large a dose,
Jekk inti aċċidentalment tagħti lilek innifsek doża kbira wisq, għid lit- tabib tiegħek.
It may be necessary to monitor your blood. ng If you forget to take Dynepo:
Jekk tinsa tieħu Dynepo M’ għandekx tieħu doża doppja biex tpatti għal kull doża li tkun insejt tieħu.
Do not take a double dose to make up for a forgotten individual dose.
Ħu d- doża li jmiss fil- ħin al
Take your next dose at the lo normal time. no
Jekk tieqaf tieħu Dynepo iċ
If you stop taking Dynepo Do not stop taking Dynepo before discussing the implications with your doctor or pharmacist. ct
Tiqafx tieħu Dynepo qabel ma tiddiskuti l- implikazzjonijiet mat- tabib jew l- ispiżjar tiegħek. ed
Injecting Dynepo yourself Your doctor may decide that it would be best for you to inject Dynepo yourself.
Kif tinjetta Dynepo lilek innifsek It- tabib tiegħek jista ’ jiddeċiedi li ikun aħjar għalik li tinjetta Dynepo inti stess.
Your doctor or nurse du
It- tabib jew in- ners m
will show you how to inject yourself.
tiegħek ser juruk kif tinjetta lilek innifsek.
Do not try to inject yourself if you have not been trained. ro
Tippruvax tinjetta lilek innifsek jekk ma tkunx ingħatajt taħriġ. t
For information on how to inject Dynepo yourself, please read the instructions at the end of this leaflet.
Għal tagħrif dwar kif tinjetta Dynepo lilek innifsek, jekk jogħġbok aqra l- istruzzjonijiet fl- aħħar ta ’ ot
a
dan il- fuljett. od