qanastek/EMEA-V3 huggingface dataset:
For the storage of unused broken tablets, see HOW TO ST0RE SIKLOS.
Għall- ħażna ta ’ pilloli maqsuma mhux użati, ara ‘ KIF TAĦŻEN SIKLOS ’.
Always take Siklos exactly as your doctor has told you.
Dożaġġ 21 Dejjem għandek tieħu Siklos eżatt kif qallek it- tabib tiegħek.
Your doctor will tell you how much of Siklos to take each day and define the dosage in whole, half or quarter tablets.
It- tabib tiegħek se jgħidlek kemm tieħu Siklos kuljum u jiddefinixxi d- dożaġġ f’ pilloli sħaħ, nofsijiet u kwartijiet.
The prescribed dose of Siklos must be taken once daily, preferably in the morning before breakfast.
Id- doża preskrikka ta ’ Siklos għandha tittieħed darba kuljum, preferibilment filgħodu qabel il - kollazzjoni.
If necessary, it can be taken with a glass of water or a very small amount of food.
Jekk hemm bzonn, tista ’ tittieħed ma ’ tazza ilma jew ma ’ ammont żgħir ħafna ta ’ ikel.
Treatment follow-up
Visti ta ’ wara l- bidu tal- kura
The duration of treatment is the responsibility of your treating physician and should be based on your physical condition and blood count.
It- tul tal- kura hija r- responsabiltá tat- tabib li qed jikkurak u għandha tkun ibbażata fuq il- kundizzjoni fiżikali tiegħek u l- għadd tad- demm.
The treating physician will monitor your blood count and adjust your dose accordingly.
It- tabib li qed jikkurak se josserva b’ mod kontinwu l- għadd tad - demm tiegħek u jirranġa d- doża skond il- riżultat.
When taking Siklos you will have regular blood tests and tests on your liver and kidney functions.
Int u tieħu Siklos se jkollok eżamijiet tad- demm regolari u eżamijiet tal- funzjoni tal- fwied u tal - kliewi.
Depending on the dosage you take, these tests may be performed every two weeks or every two months.
Skond id- dożaġġ li tieħu, dawn l- eżamijiet jistgħu jsiru kull ġimgħatejn jew kull xaharejn.
According to these results your doctor will adjust your dosage of Siklos.
It- tabib tiegħek jirranġa d- dożaġġ tiegħek ta ’ Siklos skond dawn ir- riżultati.
The growth of treated children should be regularly monitored by the treating physician.
It- tkabbir ta ’ tfal ikkurati għandu jiġi sorveljat b’ mod regolari mit- tabib li qed jikkura.
If you take more Siklos than you should
Jekk tieħu Siklos aktar milli suppost
If you take more Siklos that you should or if a child has taken any, immediately contact your doctor or the nearest hospital as you may need urgent medical treatment.
Jekk tieħu Siklos aktar milli suppost jew xi tifel jew tifla ħadu Siklos, kellem lit- tabib tiegħek jew l - eqreb sptar immedjatament, għax jista ’ jkun li jkollok bżonn kura medika urġenti.
The most common symptoms of overdose with Siklos are:
L- aktar sintomi komuni ta ’ doża eċċessiva ta ’ Siklos huma:
- Soreness (touch is painful)
- Uġigħ (uġigħ fil- post li tmiss)
- Redness of the skin
- Ħmura tal- ġilda
- Swelling of the palms of hands and soles of feet followed by the hands and feet becoming scaly
- Nefħa tal- pali ta ’ l- idejn u tal- qigħ tas- saqajn seġwit mill- formazzjoni ta ’ qoxra fl- idejn u fis -
- Skin becoming strongly pigmented (coloured)
- Pigmentazzjoni (kolorazzjoni) qawwija tal- ġilda
- Soreness or swelling in the mouth.
- Uġigħ jew nefħa fil- ħalq.
If you forget to take Siklos
Jekk tinsa tieħu Siklos
Do not take a double dose to make up for forgotten tablet.
Tieħux doża doppja biex tpatti għall- pillola li tkun insejt tieħu.
Continue as normal when it is time to take the next dose as prescribed by your doctor.
Kompli bħas- soltu meta jmissek id - doża ta ’ wara hekk kif ippreskrivilek it- tabib tiegħek.
If you stop taking Siklos
Jekk tieqaf tieħu Siklos
Do not stop your treatment unless advised by your doctor.
Twaqqafx il- kura tiegħek sakemm mhux bil- parir tat- tabib tiegħek.
If you have any further question on the use of this product, ask your doctor or pharmacist.
Jekk għandek aktar mistoqsijiet dwar l- użu ta ’ dan il- prodott, staqsi lit- tabib jew lill- ispiżjar tiegħek.
Like all medicines, Siklos can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Siklos jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Tell your doctor immediately if you experience any of the following:
X’ GĦANDEK TAGĦMEL F’ KAŻ TA ’ EFFETTI SEKONDARJI Għid lit- tabib tiegħek immedjatament jekk ikkollox xi wieħed minn dawn li ġejjin:
- A severe infection
- Infezzjoni serja ħafna
- Tiredness and/ or looking pale
- Għejja u/ jew tidher pallidu/ a
- Unexplained bruising (accumulation of blood under the tissues) or bleeding
- Tbenġil bla spjegazzjoni (jinġabar id- demm taħt it- tessuti) jew fsad ta ’ demm
- Hallucinations
- Alluċinazzjonijiet
- Seizures
- Aċċessjonijiet
- Difficulties in breathing.
- Diffikultà biex tieħu n- nifs.
All these are serious side effects of Siklos.
Dawn kollha huma effetti sekondarji serji ta ’ Siklos.
You may need medical attention.
Jista ’ jkollok bżonn attenzjoni medika.
Tell your doctor as soon as possible if you notice any of the following side effects of Siklos:
Għid lit- tabib tiegħek malajr kemm jista ’ jkun jekk tinnota xi wieħed minn dawn l- effetti sekondarji li ġejjin:
- Rash (itching red eruption of the skin)
- Raxx (il- ġilda tiħmar, bil- ponot u bil- ħakk)
- Ulcers or wounds on your legs
- Ulċeri jew feriti f’ saqajk
- Sore (open skin infection) on your skin.
- Ferita (infezzjoni tal- ġilda miftuħa) fil- ġilda tiegħek
- Fever or chills
- Deni jew tkexkix ta ’ bard
- Feeling sick, weak, lacking energy or a general feeling of being unwell
- Tħossok marid, bla saħħa, bla enerġija, jew tħossok ġeneralment ma ’ tiflaħx
- Disorientation (confusion)
- Diżorjentament (konfużjoni)
DETAILS OF SIDE EFFECTS
DETTALJI TA ’ EFFETTI SEKONDARJI
Very common side effects (occurring in more than 1 in 10 people):
Effetti sekondarji komuni ħafna (jseħħu f’ aktar minn 1 f’ kull 10 persuna):
Low blood cell counts (myelosuppression), enlargement of red blood cells, decreased resistance to infections.
Għadd ta ’ ċelloli tad- demm baxx (mijelosoppressjoni), tkabbir fid- daqs taċ- ċelloli l- ħomor tad- demm, tnaqqis fir- reżistenza għall- infezzjonijiet.
Common side effects (occurring in less than 1 in 10 people, but more than 1 in 100):
Effetti sekondarji komuni (jseħħu f’ inqas minn 1 f’ kull 10 persuna, iżda aktar minn 1 f’ kull 100 persuna):
Reduced number of red blood cells (anemia), low platelet count, headache, skin reactions, inflammation or ulceration of the mouth (oral mucositis).
Tnaqqis fl- għadd ta ’ ċelloli ħomor tad- demm (anemija), għadd ta ’ plejtlits baxx, uġigħ ta ’ ras, reazzjonijiet tal- ġilda, infjammazzjoni jew ulċeri fil- ħalq (mukosite orali).
Uncommon side effects (occurring in less than 1 in 100 people, but more than 1 in 1,000):
Effetti sekondarji mhux komuni (jseħħu f’ inqas minn 1 f’ kull 100 persuna, iżda aktar minn 1 f’ kull 1000 persuna):
Dizziness, nausea, itching red eruption of the skin (rash), black nails (melanonychia), hair loss.
Sturdament, dardir, il- ġilda ssir b’ ponot ħomor u bil- ħakk (raxx), dwiefer suwed (melanonikja), jaqa ’ x- xagħar.
Rare side effects (occurring in less than 1 in 1,000 people, but more than 1 in 10,000):
Effetti sekondarji rari (jseħħu f’ inqas minn 1 f’ kull 1000 persuna, iżda aktar minn 1 f’ kull 10. 000 persuna):
Wounds on the legs (leg ulcers), modification of liver function,
Feriti fis- saqajn (ulċeri tas- saqajn), funzjoni tal- fwied mibdula.
Very rare side effects or unknown frequency Absence or low amount of sperm in the semen (azoospermia or oligospermia).
Nuqqas jew ammont baxx ta ’ spermatozoon fis- semen (azospermja jew oligospermja).
Siklos may hence decrease the ability of men to father children.
Għalhekk, Siklos jista ’ jnaqqas l- abilità ta ’ rġiel li jkollhom it- tfal.
Isolated cases of malignant disease of blood cells (leukaemia), skin cancer in elderly patients, viral infection with Parvovirus B19, bleeding, gastrointestinal disturbances, vomiting, skin dryness, fever, absence of menstrual cycles (amenorrhoea), and weight gain.
Każijiet iżolati ta ’ marda malinna taċ- ċelloli tad- demm (lewkimja), kanċer tal- ġilda f’ pazjenti anzjani, infezzjonijiet ikkawżati mill- virus Parvovirus B19, fsad ta’ demm, disturbi gastrointestinali, rimettar, ġilda xotta, deni, nuqqas taċ- ċiklu mestrwali (amenorreja), u żieda fil- piż.
HOW TO STORE SIKLOS
KIF TAĦŻEN SIKLOS
Do not use Siklos after the expiry date which is stated on the carton and the blisters.
Tużax Siklos wara d- data ta ’ skadenza li tidher fuq il- kartuna u l- folji.
Store below 25°C.
Aħżen taħt 250 C.
Unused broken tablets must be replaced in the blister and the blister itself must be put back in its box.
Pilloli maqsuma mhux użati għandhom jerġgħu jitpoġġew fil- folja u l- folja għandha terġgħa titpoġġa fil- kaxxa tagħha.
Medicines should not be disposed of via wastewater or household waste.
23 Il- mediċini m’ għandhomx jintremew ma ’ l- ilma tad- dranaġġ jew ma ’ l- iskart domestiku.
What Siklos contains
X’ fih Siklos:
22 The active substance is hydroxycarbamide.
Is- sustanza attiva hija hydroxycarbamide.
Each film-coated tablet contains 1000 mg hydroxycarbamide.
Kull pillola miksija b’ rita fiha 1000 mg hydroxycarbamide.
The other ingredients are sodium stearyl fumarate and silicified microcrystalline cellulose and methacrylate copolymer.
Is- sustanzi l- oħra huma sodium stearyl fumarate u silicified microcrystalline cellulose u methacrylate copolymer.
What Siklos looks like and contents of the pack
Id- Dehra ta ’ Siklos u l- kontenuti tal- pakkett:
Siklos 1000 mg film-coated tablets are off-white, capsule-shaped tablets marked with three score lines on both sides.
Siklos 1000 mg pilloli miksija b’ rita huma ta ’ kulur abjad maħmuġ, forma ta ’ kapsola u bi tliet linji mnaqqxa fuq kull naħa.
The tablet can be divided into four equal parts.
Il- pillola tista ’ tinqasam f’ erba ’ partijiet indaqs.
Siklos is supplied in blisters packed in cartons containing 30 tablets.
Siklos jiġi f’ folji ppakkjati f’ kaxxi li fihom 30 pilloli.
Marketing Authorisation Holder Addmedica 84 rue d'Amsterdam 75009 Paris France
Addmedica 84 rue d' Amsterdam 75009 PARIĠI Franza
Manufacturer Laboratoire Elaïapharm 2881 Route des Crêtes Z. I.
Laboratoire Elaïapharm 2881 Route des Crêtes Z. I.
Les Bouillides - Sophia Antipolis 06560 Valbonne France
Les Bouillides - Sophia Antipolis 06560 Valbonne Franza
This leaflet was last approved in ….
Dan il- fuljett ġie approvat l- aħħar fl -....
Detailed information on this medicine is available on the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/.
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il - Mediċini (EMEA) http: // www. emea. europa. eu /.
ANNEX IV
ANNESS
1 CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE ADDRESSED TO THE MEMBER STATES
1 KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FIR- RIGWARD TA ’ L- UŻU MINGĦAJR PERIKLU U EFFETTIV TAL- PRODOTT MEDIĊINALI LI GĦANDHOM JIĠU INDIRIZZATTI MILL- ISTATI MEMBRI
The Member States shall ensure that the MAH, prior to launch, provides all physicians who are expected to prescribe Siklos with a physician information pack containing the following: • Treatment guide for physicians • Patient information pack
l- Istati Membri ser jiżguraw li meta l- prodott jitqiegħed fis- suq, id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq jipprovdi pakkett ta ’ informazzjoni għat- tabib lit- tobba kollha li huma mistennija li jippreskrivu Siklos li fih dan li ġej: • Gwida dwar il- kura għat- tobba • Pakkett ta ’ informazzjoni għall- pazjent
The educational leaflet shall contain the following key elements: • That the use of epoetin alfa products can cause immunogenicity which in rare cases may lead to Pure Red Cell Aplasia (PRCA) • That with other epoetin products, the risk of immunogenicity in Chronic Renal Failure (CRF) is increased with the subcutaneous route. • There is insufficient data on Silapo/ Retacrit to know the size of any increased immunogenicity risk with subcutaneous use • Therefore, the sc route is not recommended for patients with CRF • Loss of efficacy or other symptoms of the development of immunogenicity should be investigated • Any suspected case of Pure Red Cell Aplasia or development of immunogenicity should be reported to the MAH
Il- fuljett edukattiv għandu jkun fih l- elementi importanti li ġejjin: • Li l- użu tal- prodotti li fihom epoetin alfa jistagħu jikkawżaw immunoġeniċità li f’ każijiet rari tista’ twassal għal Aplasija taċ- Ċelluli l- Ħomor Pura (PRCA) • Li ma ’ prodotti oħrajn ta ’ epoetin, ir- riskju ta ’ immunoġeniċità f’ Mard Kroniku tal- Kliewi (CRF) jiżdied meta jingħata minn taħt il- ġilda (sc). • Hemm informazzjoni insuffiċjenti fuq Silapo biex ikun magħruf il- kobor ta ’ xi żieda fir- riskju ta ’ immunoġeniċità bl- użu minn taħt il- ġilda • Għalhekk, ir- rotta ta ’ taħt il- ġilda mhix rakkomandata għal pazjenti li għandhom CRF • It- telf ta ’ effikaċja jew sintomi oħrajn ta ’ l- iżvilupp ta ’ immunoġeniċità għandhom ikunu investigati • Kwalunkwe każ suspettat ta ’ Aplasija taċ- Ċelluli l- Ħomor Pura jew l- iżvilupp ta ’ immunoġeniċità għandhom ikunu rrappurtati lill- MAH
What is Silapo?
X’ inhu Silapo?
Silapo is a solution for injection.
Silapo huwa soluzzjoni għall- injezzjoni.
Silapo is a ‘ biosimilar’ medicine.
Silapo huwa mediċina ‘ bijosimili ’.
This means that Silapo is similar to a biological medicine that is already authorised in the European Union (EU) and contains a similar active substance (also known as the ‘ reference medicine’).
Dan ifisser li Silapo jixbah lil mediċina bijoloġika li diġà hija awtorizzata fl- Unjoni Ewropea (UE) u li fiha sustanza attiva simili (magħrufa bħala ‘ mediċina ta ’ referenza ’).
The reference medicine for Silapo is EPREX/ ERYPO, which contains epoetin alfa.
Il- mediċina ta ’ referenza għal Silapo hi EPREX/ ERYPO, li fih epoetin alfa.
What is Silapo used for?
Għal xiex jintuża Silapo?
Silapo is used to stimulate red blood cell production in the following situations: • to treat anaemia (low red blood cell counts) caused by chronic renal failure (long-term, progressive decrease in the ability of the kidneys to work properly) or other kidney problems, • to treat anaemia and reduce the need for blood transfusions in adults receiving chemotherapy for certain types of cancer, • to increase the amount of blood that patients with moderate anaemia can donate before surgery, so that their own blood can be given back to them during or after surgery.
Silapo jintuża biex jistimula l- produzzjoni taċ- ċelloli tad- demm ħomor f’ dawn is- sitwazzjonijiet: • Biex jittratta l- anemija (għadd baxx ta ’ ċelloli ħomor) ikkawżata minn falliment kroniku tal- kliewi (tnaqqis progressiv, fit- tul fil- kapaċità tal- kliewi li jaħdmu kif suppost) jew ta ’ problemi oħra fil - kliewi, • Biex jittratta l- anemija u biex inaqqas il- ħtieġa għal trasfużjonijiet fl- adulti li jkunu qed jingħataw il- kemjoterapija għal ċerti tipi ta ’ kanċer, • Biex jiżdied l- ammont ta ’ demm li l- pazjenti b’ anemija moderata jkunu jistgħu jagħtu qabel operazzjoni, biex id- demm tagħhom ikun jista ’ jingħatalhom lura waqt jew wara operazzjoni.
How is Silapo used?
Kif jintuża Silapo?
Treatment with Silapo must be initiated under the supervision of doctors who have experience in the management of patients with the conditions that the medicine is used for.
It- trattament b’ Silapo għandu jinbeda taħt is- superviżjoni ta ’ tobba li jkollhom esperjenza fil- ġestjoni ta ’ pazjenti bil- kundizzjonijiet li għalihom tintuża l- mediċina.
For patients with kidney problems or about to undergo surgery, Silapo must be injected intravenously (into a vein), while patients receiving chemotherapy receive it subcutaneously (under the skin).
Għal pazjenti bi problemi fil- kliewi li jkunu waslu biex jagħmlu operazzjoni, Silapo għandu jiġi injettat fil- vina, waqt li l- pazjenti li jkunu qed jingħataw il- kemjoterapija jeħduha taħt il- ġilda.
The dose, the frequency of injection and how long it is used for depend on why Silapo is being used, and are adjusted according to the patient’ s response.
Id- doża, il- frekwenza ta ’ l- injezzjoni u kemm iddum tingħata jiġu adattati skond ir- rispons tal- pazjent.
How does Silapo work?
Kif jaħdem Silapo?
The active substance in Silapo, epoetin zeta, is a copy of human erythropoietin and works in exactly the same way as the natural hormone to stimulate red blood cell production.
Is- sustanza attiva f' Silapo, epoetin zeta, hija kopja ta ’ l- eritropojetina umana u taħdem eżatt bl- istess mod bħall- ormun naturali biex tistimula l- produzzjoni taċ- ċelloli tad- demm ħomor.
The active substance in Silapo, epoetin zeta, is produced by ‘ recombinant DNA technology’: it is made by a cell that has received a gene (DNA), which makes it able to produce erythropoietin.
Is- sustanza attiva f’ Silapo, epoetin zeta, tiġi prodotta bit - ‘ teknoloġija rikombinanti tad- DNA ’: jiġi prodott minn ċellola li tkun irċeviet ġene (DNA), li jagħmilha kapaċi tipproduċi l- eritropojetina.
How has Silapo been studied?
Kif ġie studjat Silapo?
Silapo was studied to show that it is comparable with the reference medicine, EPREX/ ERYPO, in experimental models and in humans.
Silapo ġie studjat biex juri li jista ’ jitqabbel mal- mediċina tar- referenza, EPREX/ ERYPO, f’ mudelli sperimentali u fil- bniedem.
Silapo, injected intravenously, was compared with the reference medicine in two main studies involving 922 patients who had anaemia associated with chronic renal failure requiring haemodialysis (a blood clearance technique).
Silapo, injettat fil- vina, tqabbel mal- mediċina ta ’ referenza f’ żewġ studji ewlenin li fihom ħadu sehem 922 pazjent li jbatu minn anemija assoċjata ma ’ falliment kroniku tal- kliewi li jkun jeħtieġ l - emodijaliżi (teknika ta ’ depurazzjoni tad- demm).
The first study compared the effects of Silapo with those of EPREX/ ERYPO in correcting red blood cell counts in 609 patients over 24 weeks.
L- ewwel studju qabbel l- effetti ta ’ Silapo ma ’ dawk ta ’ EPREX/ ERYPO fil- korrezzjoni tal- għadd ta ’ ċelloli tad- demm ħomor f’ 609 pazjenti matul 24 ġimgħa.
The second study compared the effects of Silapo with those of EPREX/ ERYPO in maintaining red blood cell counts in 313 patients.
It- tieni studju qabbel l- effetti ta ’ Silapo ma ’ dawk ta ’ EPREX/ ERYPO fil- manteniment tal- għadd ta ’ ċelloli tad- demm fi 313- il pazjent.
All of the patients in the second study had been receiving treatment with EPREX/ ERYPO for at least three months before they were either switched to Silapo or remained on EPREX/ ERYPO for 12 weeks.
Il- pazjenti kollha fit- tieni studju kienu ilhom jingħataw it- trattament b’ EPREX/ ERYPO għal ta ’ l- anqas tliet xhur qabel ma ’ qalbu għal Silapo jew tħallew fuq EPREX/ ERYPO għal 12- il ġimgħa.
The company also presented the results of a study looking at the effects of Silapo injected subcutaneously in 261 cancer patients taking chemotherapy.
Il- kumpanija ppreżentat ukoll ir- riżultati ta ’ studju li jħares lejn l- effetti ta ’ Silapo injettat taħt il- ġilda f’ 261 pazjent bil- kanċer li kienu qed jieħdu l- kemjoterapija.
What benefit has Silapo shown during the studies?
X’ inhu l- benefiċċju ta ’ Silapo li ntwera f’ dawn l- istudji?
Silapo was as effective as EPREX/ ERYPO in correcting and maintaining red blood cell counts.
Silapo kien effikaċi daqs EPREX/ ERYPO fil- korrezzjoni u fil- manteniment tal- għadd ta ’ ċelloli tad - demm ħomor.
In the study of patients already being treated with an epoetin, haemoglobin levels were maintained to the same extent when the patients were receiving Silapo and when they were receiving EPREX/ ERYPO, at around 11.4 g/ dl.
Fl- istudju ta ’ pazjenti li diġà kienu qed jingħataw epoetina, il- livelli ta ’ l- emoglobina nżammu sa l- istess punt meta l- pazjenti kienu qed jirċievu EPREX/ ERYPO, f’ madwar 11. 4 g/ dl.
The study in patients receiving chemotherapy showed that Silapo was also effective when it was injected subcutaneously, with similar improvements in haemoglobin levels as those reported in the scientific literature for other epoetins.
L- istudju f’ pazjenti li kienu qed jingħataw il- kemjoterapija wrew li Silapo kien effikaċi wkoll meta jiġi injettat taħt il- ġilda, b’ titjib simili fil- livelli ta ’ emoglobina bħal dawk rappurtati fil- letteratura xjentifika ta ’ epoetini oħra.
What is the risk associated with Silapo?
X’ inhu r- riskju assoċjat ma ’ Silapo?
As with other medicines containing an epoetin, the most common side effect with Silapo is an increase in blood pressure, which can sometimes lead to symptoms of encephalopathy (brain problems) such as sudden, stabbing migraine-like headache and confusion.
Bħall- mediċini l- oħrajn li jkun fihom epoetina, l- iktar effetti sekondarji komuni ma ’ Silapo jinkludu żieda fil- pressjoni, li xi drabi tista ’ twassal għal sintomi ta ’ enċefalopatija (problemi fil- moħħ) bħal konfużjoni u uġigħ ta ’ ras jixbah lill- emikranja penetranti u f’ daqqa.
Silapo can also lead to skin rash and flu-like symptoms.
Silapo jista ’ jwassal għal raxx fil - ġilda u sintomi jixbhu lill- influwenza.
For the full list of all side effects reported with Silapo, see the Package Leaflet.
Għal- lista sħiħa ta ’ effetti sekondarji rrappurtati ma ’ Silapo, ara l- Fuljett ta ’ Tagħrif.
Silapo should not be used in people who may be hypersensitive (allergic) to epoetin zeta or any of the other ingredients.
Silapo m’ għandux jintuża minn persuni li jistgħu jkunu allerġiċi għal epoetin zeta jew għal kwalunkwe sustanza oħra.
Silapo is not recommended for subcutaneous injection in the treatment of kidney problems because further studies are needed to make sure that this does not cause allergic reactions.
Silapo mhux rakkomandat għall- injezzjoni taħt il- ġilda fit- trattament ta ’ problemi tal- kliewi minħabba li hemm bżonn ta ’ iktar studji biex ikun żgurat li dan ma jikkawżax reazzjonijiet allerġiċi.
Why has Silapo been approved?
Għaliex ġie approvat Silapo?
The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Silapo has been shown to have a comparable quality, safety and efficacy profile to
Għalhekk, skond il- fehma tal- CHMP,
©EMEA 2007
©EMEA 2007 bħal fil- każ ta ’ EPREX/ ERYPO, il- benefiċċju
EPREX/ ERYPO.
jegħleb lir- riskju.
The Committee recommended that Silapo be given marketing authorisation.
Il- Kumitat irrakkomanda li Silapo jingħata l- awtorizzazzjoni għat- tqegħid fis- suq.
Which measures are being taken to ensure the safe use of Silapo?
X’ miżuri qed jittieħdu biex ikun żgurat l- użu sigur ta ’ Silapo?
The company that makes Silapo will provide information packs for healthcare workers in all Member States, including information on the safety of the medicine.
Il- kumpanija li tagħmel Silapo se tipprovdi pakketti ta ’ tagħrif għal min jaħdem fil- ħarsien tas- saħħa fl- Istati Membri kollha, li fihom ikun hemm tagħrif dwar is- sigurtà tal- mediċina.
Other information about Silapo:
Tagħrif ieħor dwar Silapo:
The European Commission granted a marketing authorisation valid throughout the EU for Silapo to STADA Arzneimittel AG on 18 December 2007.
Il- Kummissjoni Ewropea tat l- awtorizzazzjoni għat- tqegħid fis- suq għal Silapo valida madwar l- UE lil STADA Arzneimittel AG fit - 18 ta ’ Diċembru 2007.
The full EPAR for Silapo can be found here.
L- EPAR sħiħ għal Silapo jinsab hawn.
1.0 ml (40000 IU/ ml)
1. 0 ml (40000 IU/ ml)
Silapo 1000 IU/ 0.3ml solution for injection in pre-filled syringe
Silapo 1000 IU/ 0. 3 ml soluzzjoni għall- injezzjoni f’ siringa mimlija minn qabel
− Treatment of symptomatic anaemia associated with chronic renal failure (CRF) in adult and paediatric patients: o Treatment of anaemia associated with chronic renal failure in adult and paediatric patients on haemodialysis and adult patients on peritoneal dialysis (See section 4.4). o Treatment of severe anaemia of renal origin accompanied by clinical symptoms in adult patients with renal insufficiency not yet undergoing dialysis (See section 4.4). − Treatment of anaemia and reduction of transfusion requirements in adult patients receiving chemotherapy for solid tumours, malignant lymphoma or multiple myeloma, and at risk of transfusion as assessed by the patient's general status (e. g. cardiovascular status, pre-existing anaemia at the start of chemotherapy). − Silapo can be used to increase the yield of autologous blood from patients in a predonation programme.
− Trattament għal anemija sintomatika assoċjata ma ’ falliment renali kroniku (CRF) f’ pazjenti adulti u tfal: o Trattament għal anemija assoċjata ma ’ falliment renali kroniku f’ pazjenti adulti u tfal fuq emodijalisi u pazjenti adulti fuq dijalisi peritoneali (Ara sezzjoni 4. 4). o Trattament għal anemija severa li ġejja mill- kliewi akkumpanjata minn sintomi kliniċi f’ pazjenti adulti b’ insuffiċjenza tal- kliewi li għad mhux ikollhom dijalisi (Ara sezzjoni 4. 4). − Trattament ta ’ anemija u nuqqas ta ’ bżonnijiet ta ’ trasfużjoni f’ pazjenti adulti li qegħdin jirċievu l- kimoterapija għal tumuri solidi, limfoma malinn jew myeloma multiplu, u f’ riskju ta ’ trasfużjoni kif assessjat mill- istatus ġenerali tal- pazjent (e. g. status kardjovaskulari, anemija pre - eżistenti fil- bidu tal- kimoterapija). − Silapo jista ’ jintuża sabiex tiżdied il- ġabra ta ’ demm awtologu minn pazjenti li qegħdin f’ programm ta ’ qabel id- donazzjoni.
Treatment with Silapo has to be initiated under the supervision of physicians experienced in the management of patients with above indications.
It- trattament b’ Silapo għandu jibda taħt superviżjoni ta ’ tobba b’ esperjenza fil- kura tal- pazjenti bl - indikazzjonjiet ta ’ hawn fuq.
The haemoglobin concentration aimed for is between 10 and 12 g/ dl (6.2-7.5 mmol/ l), except in paediatric patients in whom the haemoglobin concentration should be between 9.5 and 11 g/ dl (5.9-6.8 mmol/ l).
F’ pazjenti b’ falliment renali kroniku l- prodott mediċinali għandu jingħata minn ġol- vina (ara sezzjoni 4. 4) 2 Il- konċentrazzjoni tal- emoglobina mixtieqa għandha tkun ta ’ bejn 10 u 12 g/ dl (6. 2- 7. 5mmol/ l) ħlief f’ pazjenti tfal fejn il- konċentrazzjoni tal- emoglobina għandha tkun bejn 9. 5 u 11 g/ dl (5. 9- 6. 8 mmol/ l).
2 Anemia symptoms and sequaelea may vary with age, gender and overall burden of disesase; a physician´s evaluation of the individual patient´s clinical course and condition is necessary.
Is- sintomi ta ’ anemija u sequaelea jistgħu jvarjaw skond l- età, il- ġeneru u l- qawwa globali tal- mard; evalwazzjoni mit- tabib tal- kors kliniku u l- kundizzjoni individwali tal- pazjent hi meħtieġa.
Silapo should be administered intravenously in order to increase haemoglobin to not greater than 12 g/ dL (7.5 mmol/ L) Due to intra-patient variability, occasional individual haemoglobin values for a patient above and below the desired haemoglobin level may be observed.
Kull tant żmien, minħabba l- varjabilità bejn pazjent u ieħor, jiġu osservati valuri individwali tal- emoglobina li jkunu ’ l fuq jew ’ l isfel mil- livell mixtieq tal- emoglobina.
Patients should be monitored closely to ensure that the lowest approved dose of Silapo is used to provide adequate control of the symptoms of anemia.
Pazjenti għandhom jiġu monitorati mill- qrib sabiex jiġi żgurat li tingħata biss l- anqas doża approvata ta ’ Silapo sabiex ikun hemm kontroll adegwat għas- sintomi ta ’ l- anemija.
3 Adult patients on peritoneal dialysis The treatment is divided into two stages:
Pazjenti adulti fuq dijalisi peritonjali It- trattament huwa maqsum f’ żewġ stadji:
Silapo should be administered by the subcutaneous route to patients with anaemia (e. g. haemoglobin concentration ≤ 10 g/ dl (6.2 mmol/ l).
Silapo jista ’ jingħata taħt il- ġilda lil pazjenti b’ anemija (eż. konċentrazzjoni tal- emoglobina ≤ 10 g/ dl (6. 2 mmol/ l).
Patients should be monitored closely to ensure that the lowest approved dose of Silapo is used to provide adequate control of the symptoms of anaemia.
Pazjenti għandhom jiġu monitorati mill- qrib sabiex jiġi żgurat li tintuża biss l- anqas doża approvata ta ’ Silapo biex tipprovdi kontroll adegwat għas- sintomi ta ’ l- anemija.
Silapo therapy should continue until one month after the end of chemotherapy.
It- terapija b’ Silapo għanda tibqa ’ sa xahar wara t- tmiem tal- kimoterapija.
Alternatively, Silapo can be administered at an initial dose of 450 IU/ kg subcutaneously once weekly.
Jew inkella, Silapo jista ’ jingħata f’ doża tal- bidu ta ’ 450 IU/ kg taħt il- ġilda darba fil- ġimgħa.
Appropriate dose titration should be considered.
150 IU/ kg 3x/ ġimgħa jew 450 IU/ kg darba fil- ġimgħa
Dose adjustment At a rate of rise in haemoglobin of > 2 g/ dl (> 1.25 mmol/ l) per month the Silapo dose should be reduced by about 25-50%.
Żieda fl- għadd ta ’ retikuloċiti ≥ 40, 000/ µl jew żieda fl- Hb ≥ 1 g/ d
If haemoglobin level exceeds 12 g/ dl (7.5 mmol/ l), discontinue therapy until it falls to 12 g/ dl (7.5 mmol/ l) or lower and then reinstitute Silapo therapy at a dose 25% below the previous dose.
Żieda fl- għadd ta ’ retikuloċiti < 40, 000/ µl u żieda fl- Hb < 1 g/ dl
Silapo should be given by the intravenous route.
Aġġustament fid- doża F’ rata ta ’ żieda fl- emoglobina ta ’ > 2 g/ dl (> 1. 25 mmol/ l) fix- xahar id- doża ta ’ ’ Silapo għanda tonqos b’ xi 25- 50%.
At the time of donating blood, Silapo should be administered after the completion of the blood donation procedure.
Fil- mument ta ’ donazzjoni tad- demm, Silapo għandu jingħata wara t- tlestija tal- proċedura tad - donazzjoni tad- demm.
Mildly anaemic patients (haematocrit of 33-39%) requiring predeposit of ≥ 4 units of blood should be treated with Silapo at a dose of 600 IU/ kg body weight 2 times weekly for 3 weeks prior to surgery.
Pazjenti b’ anemija ħafifa (ematokrit ta ’ 33- 39%) li għandhom bzonn depozitu minn qabel ta ’ ≥ 4 unità ta ’ demm għandhom jiġu ttratati b’ Silapo b’ doża ta ’ 600 IU/ kg tal- piż tal- ġisem darbtejn fil ġimgħa għal 3 ġimgħat qabel il- kirurġija.
All patients being treated with Silapo should receive adequate iron supplementation (e. g.
Il- pazjenti kollha li qegħdin jiġu ttratati b’ Silapo għandhom jirċievu supplementazzjoni tal- ħadid biżżejjed (eż.
Iron supplementation should be started as soon as possible, even several weeks prior to initiating the autologous predeposit, in order to achieve high iron stores prior to starting Silapo therapy.
Is - suplimentazzjoni tal- ħadid għandha tibda mill- aktar fis possibli, anke diversi ġimgħat qabel ma jibda id- depożitu awtologu ta ’ qabel, sabiex jilħaq jinġemgħu livelli ta ’ kwantità ta ’ ħadid qabel ma tibda ’ it- terapija b’ Silapo.
5 Method of administration
Injezzjoni fil- vini Id- doża għandha tingħata fuq medda ta ’ mill- anqas 5 minuti, skond id- doża sħiħa.
Silapo must not be mixed with other medicinal products (see section 6.2).
Silapo m’ għandux jingħata f’ infużjoni fil- vini, jew imħallat ma ’ prodotti oħra mediċinali (ara sezzjoni 6. 2).
In chronic renal failure patients Silapo has not to be administered subcutaneously.
F’ pazjenti b’ nuqqas kroniku renali Silapo m’ għandux ikun amministrat minn taħt il- ġilda.
− Hypersensitivity to the active substance or to any of the excipients. − Patients who develop Pure Red Cell Aplasia (PRCA) following treatment with any erythropoietin must not receive Silapo or any other erythropoietin (see section 4.4). − Uncontrolled hypertension. − In the indication "increasing the yield of autologous blood": myocardial infarction or stroke in the month preceding treatment, unstable angina pectoris, increased risk of deep venous thrombosis such as history of venous thromboembolic disease. − Patients who for any reason cannot receive adequate antithrombotic prophylaxis.
− Sensittività eċċessiva għas- sustanza attiva jew għal xi sustanzi mhux attivi. − Pazjenti li jiżviluppaw Pure Red Cell Aplasia (PRCA) wara trattament b’ xi eritropojetin m’ għandux jirċievi Silapo jew kwalunkwe eritropojetin ieħor (ara sezzjoni 4. 4). − Pressjoni għolja mhix ikkontrollata. − Fl- indikazzjoni "żieda fil- ġabra ta ’ demm awtologiku": infart mijokardjali jew puplesija fix - xahar ta ’ qabel jibda ’ it- trattament, anġina pectoris instabbli, żieda fir- risku ta ’ trombosi fil- vini profondi bħal ma hija storja personali ta ’ mard tromboemboliku venuż. − Pazjenti li għal xi raġuni ma jistgħux jirċievu profilassi antitrombotika adegwata.
General
6 Ġenerali
Like in all patients receiving erythropoietin, blood pressure may rise during treatment with Silapo.
Bħal f’ pazjenti kollha li jirċievu l- eritropojetin, il- pressjoni tad- demm tista ’ titla ’ matul it- trattament b’ Silapo.
Blood pressure should be closely monitored and adequately controlled in all epoetin treatment naïve as well as pre-treated patients before, at initiation of, and during treatment with Silapo.
Il- pressjoni tad- demm għandha tiġi moniterjata mill- qrib u kkontrollata adegwatament fit - trattament tal- epoetin naïve kif ukoll f’ pazjenti ttrattati minn qabel, fil- bidu ta ’, u matul it- trattament b’ Silapo.
If blood pressure cannot be well controlled, Silapo treatment should be discontinued.
Jekk il- pressjoni tad - demm ma tkunx tista ’ tiġi kkontrollata, it- trattamanet b’ Silapo għandu jitwaqqaf.
Silapo should also be used with caution in the presence of epilepsy and chronic liver failure.
Silapo għandu jintuża wkoll bil- galbu fil- presenza ta ’ epilessija u insuffiċjenza kronika tal- fwied.
All other causes of anaemia (iron deficiency, haemolysis, blood loss, vitamin B12- or folate deficiencies) should be considered and treated prior to initiating and during therapy with Silapo.
Il- kawżi l- oħra kollha ta ’ anemija (defiċjenza fil- ħadid, emolisi, telf ta ’ demm, vitamina B12 - jew defiċjenzi fil- folates) għandhom jiġu kkunsidrati u ttratati qabel il- bidu u waqt it- terapija b’ Silapo.
In most cases, the ferritin values in the serum fall simultaneously with the rise in packed cell volume.
Fil - biċċa l- kbira tal- każijiet, il- valuri tal- ferritin fis- serum jaqgħu fl- istess waqt li jiżdied il- volum taċ - ċelluli ppakjati.
200-300 mg/ day orally (100-200 mg/ day for paediatric patients) is recommended for chronic renal failure patients whose serum ferritin levels are below 100 ng/ ml
200- 300 mg/ jum b’ mod orali (100- 200 mg/ jum għall- pazjenti pedjatriċi) huwa rrakomandat għall- pazjenti li għandhom insuffiċjenza renali kronika li l- livelli tas- serum ferritin tagħhom huma taħt il- 100 ng/ ml − sostituzzjoni ta- ħadid orali ta ’ 200- 300 mg/ jum huwa rrakomandat għall- pazjenti kollha bil - kanċer li s- saturazzjoni tat- transferrin tagħhom huwa taħt l- 20%
Immunogenicity data for subcutaneous use of Silapo in patients at risk for antibody-induced Pure Red Cell Aplasia (PRCA), i. e. patients with renal anaemia, are not sufficient.
Id- data tal- immunogeniċità għall- użu ta ’ Silapo taħt il- ġilda f’ pazjenti b’ riskju ta ’ Pure Red Cell Aplasia (PRCA) ġejja minn antikorpi, i. e. pazjenti b’ anemija renali, mix suffiċjenti.
Non response to erythropoietin therapy should prompt a search for causative factors.
7 In- nuqqas ta ’ rispons għat- terapija bl- eritropojetin għandu iwassal għal tfitxxija ta ’ fatturi kawżattivi.
If PRCA is diagnosed, therapy with Silapo must be immediately discontinued and testing for erythropoietin antibodies should be considered.
Jekk il- PRCA huwa ddijanjostikat, it- terapija b’ Silapo trid titwaqqaf immedjatament u ttestjar għall - antikorpi tal- eritropojetin għandu jiġi kkunsidrat.
7 Hyperkalaemia has been observed in isolated cases.
Il- iperkalemija ġiet osservata f’ kazijiet iżolati.
In cancer patients receiving chemotherapy, the 2-3 week delay between erythropoietin administration and the appearance of erythropoietin-induced red cells should be taken into account when assessing if Silapo therapy is appropriate (patient at risk of being transfused).
F‘ pazjenti tal- kanċer li qegħdin jirċievu l- kimoterapija, id- dewmien ta ’ 2- 3 gimgħat bejn l - amministrazzjoni tal- eritropojetin u d- dehra ta ’ ċelluli ħomor ikkaġunati mil- eritropojetin għandu jitqies meta jiġi assessjat jekk it- terapija b’ Silapo hijiex adattata (il- pazjent huwa f’ riskju li jiġi trasfuzjat).
If the rate of increase in haemoglobin exceeds 2 g/ dl (1.25 mmol/ l) per month or the haemoglobin level exceeds 12 g/ dl (7,5 mmol/ l), the dose adjustment detailed in section 4.2 should be thoroughly performed to minimise the risk of thrombotic events (see section 4.2).
Jekk ir- rata fiż- żieda tal- emoglobina taqbeż iż- 2 g/ dl (1. 25 mmol/ l) kull xahar jew il- livell tal- emoglobina jaqbeż it- 12 g/ dl (7. 5 mmol/ l), l- aġġustament tad- doża kif spjegata f - sezzjoni 4. 2 għandu jsir sabiex jitnaqqas ir- riskju ta ’ waqtiet trombotiċi (ara sezzjoni 4. 2).
As an increased incidence of thrombotic vascular events (TVEs) has been observed in cancer patients receiving erythropoietic agents (see section 4.8), this risk should be carefully weighed against the benefit to be derived from treatment (with Silapo) particularly in cancer patients with an increased risk of thrombotic vascular events, such as obesity and patients with a prior history of TVEs (e. g. deep venous thrombosis or pulmonary embolism).
Trombożi venuża fonda jew emboliżmu pulmonarju).
All special warnings and precautions associated with autologous predonation programs, especially routine volume replacement, should be respected.
8 It- twissijiet u l- prekawzjonijiet speċjali assoċjati ma ’ programmi ta ’ pre- donazzjonijiet awtoloġi, speċjalment bdil ta ’ rutina fil- volum, għandhom jiġu rispettati.
As with all growth factors, there is a concern that epoetins could stimulate the growth of any type of malignancy.
Bħal fil- każ tal- fatturi ta ’ l- iżvilupp kollha, hemm tħassib li l- epoetini jistgħu jistimulaw l- iżvilupp ta ’ kwalunkwe tip ta ’ tumuri malinni.
In several controlled studies, epoetins have not been shown to improve overall survival or decrease the risk of tumour progression in patients with anaemia associated with cancer.
F’ diversi studji kontrollati, l- epoetini ma wrewx titjib fis - sopravivenza globali jew tnaqqis fir- riskju ta ’ firxa tat- tumuri f’ pazjenti b’ anemija assoċjata ma ’ kanċer.
Several controlled clinical studies in which epoetins were administered to patients with a variety of common tumours including squamous head and neck cancer, lung cancer, and breast cancer, have shown an unexplained excess mortality.
Diversi studji kliniċi b’ kontrolli li saru li fihom l- epoetini ġew mogħtija lil pazjenti b’ diversi tipi ta ’ tumuri komuni li jinkludu kanċer skwamuż tar- ras u l- għonq, kanċer tal- pulmun, u l- kanċer tas- sider urew mortalità eċċessiva mhux spjegabbli.
increased risk of death when administered to target a haemoglobin of 12 g/dl (7.5 mmol/l) in patients with active malignant disease receiving neither chemotherapy nor radiation therapy.
Fi studji kliniċi b’ kontrolli, l- użu ta ’ Epoetin alfa u sustanzi oħra li jistimulaw eritropojesi (ESAs) urew: • żmien imqassar għal progressjoni tat- tumur fil- pazjenti b’ kanċer tar- ras u ta ’ l- għonq avvanzat li qed jirċievu terapija ta ’ radjazzjoni meta jingħata biex jintaħaq livell ta ’ emoglobina ta ’ aktar minn 14 g/ dl (8, 7 mmol/ l). • tnaqqis fis- sopravivenza globali u żieda fl- imwiet attribwiti għal firxa tal- marda fi żmien 4 xhur f’ pazjenti b’ kanċer metastatiku tas- sider li qed jirċievu kimoterapija meta jingħata biex jintlaħaq livell ta ’ emoglobina ta ’ 12- 14 g/ dl (7. 5 - 8. 7 mmol/ l), • żieda fir- riskju ta ’ mewt meta jingħata sabiex jintlaħaq livell mixtieq ta ’ emoglobina ta ’ 12 g/ dl (7. 5 mmol/ l) f’ pazjenti b’ mard malinn attiv li la qed jirċievu kimoterapija u lanqas terapija ta ’ radjazzjoni.
The decision to administer recombinant erythropoietins should be based on a benefit-risk assessment with the participation of the individual patient, which should take into account the specific clinical context.
In vista ta ’ dak imsemmi hawn fuq, f’ xi sitwazzjonijiet kliniċi t- trasfużjoni tad- demm għandu jkun it- trattament ippreferut għal ġestjoni ta ’ anemija f’ pazjenti bil- kanċer, Id- deċiżjoni sabiex jiġu amministrati eritropoijetini għandha tittieħed fuq bażi tal- istima dwar is- siwi - riskju bil - partiċipazzjoni tal- pazjent individwali, b’ konsiderazzjoni għal kuntest kliniku speċifiku.
Factors that should be considered in this assessment should include the type of tumour and its stage; the degree of anaemia; life- expectancy; the environment in which the patient is being treated; and patient preference (see section 5.1).
Fatturi li għandhom jiġu kkonsidrati f’ din l- istima għandhom jinkludu t- tip ta ’ tumur u l- istadju li jkun wasal fih; il- grad tal- anemija; kemm mistennija tgħix persuna; l- ambjent fejn il- pazjent qed jiġi trattat; u l - preferenza tal- pazjent (ara sezzjoni 5. 1).
Silapo has no or negligible influence on the ability to drive and use machines.
9 Silapo m’ għandux jew għandu ftit li xejn effett fuq il- ħila biex issuq u tħaddem magni.
Silapo is a biological medicinal product.
Silapo huwa prodott mediċinali bijoloġiku.
Data from clinical studies with Silapo are in line with the safety profile of other authorized erythropoietins.
Data minn studji kliniċi b’ Silapo huma simili fil- profil tas - sigurtà ma ’ erythropojetini awtorizzati oħra.
These undesirable effects are most commonly headache and a dose dependent increase in blood pressure.
L- effetti mhux mixtieqa l- aktar komuni huma uġigħ ta ’ ras u żieda fil- pressjoni tad- demm li tiddependi mid- doża.
Thrombotic/vascular events, such as myocardial ischaemia, myocardial infarction, cerebrovascular accidents (cerebral haemorrhage and cerebral infarction), transient ischaemic attacks, deep vein thrombosis, arterial thrombosis, pulmonary emboli, aneurysms, retinal thrombosis, and clotting of an artificial kidney have been reported in patients receiving erythropoietic agents.
Episodji trombotiċi/ vaskulari, bħal iskemija mijokardijaka, infart mijokardijaku, inċidenti ċerebrovaskulari (emorraġija ċerebrali u infart ċerebrali), attakki iskemiċi temporanji, trombożi tal - vini profonda, trombożi arterjali, emboli pulmonari, anewriżmi, trombożi fir- retina, u tagħqid ta ’ demm f’ kilwa artifiċjali kienu rrappurtati f’ pazjenti li kienu qed jirċievu sustanzi eritropojetiċi.
9 Hypersensitivity reactions have been rarely reported with epoetin alfa including isolated cases of angioedema and anaphylactic reaction.
Reazzjonijiet ta ’ sensittività eċċessiva kienu rrappurtati f’ każijiet rari b’ epoetin alfa, inklużi każijiet iżolati ta ’ anġoedema u reazzjoni anafilattika.
The following reactions have also occurred in isolated patients with normal or low blood pressure: hypertensive crisis with encephalopathy-like symptoms (e.g. headaches and confused state) and generalised tonoclonal seizures, requiring the immediate attention of a physician and intensive medical care.
Ir- reazzjonijiet li ġejjin seħħew ukoll f’ pazjenti iżolati bi pressjoni tad- demm normali jew baxxa: kriżi ta ’ pressjoni għolja b’ sintomi bħal ta ’ l- enċefalopatija (eż. uġigħ ta ’ ras u stat konfuż) u aċċessjonijiet tonokloniċi ġeneralizzati, li kienu jeħtieġu l- attenzjoni immedjata ta ’ tabib u kura medika intensiva.
Shunt thromboses may occur, especially in patients who have a tendency to hypotension or whose arteriovenous fistulae exhibit complications (e.g. stenoses, aneurysms, etc.).
Jistgħu jseħħu trombożi fix- xant, speċjalment f’ pazjenti li jkollhom tendenza għal pressjoni baxxa jew li l- fistuli bejn l- arterji u l- vini tagħhom juru komplikazzjonijiet (eż. stenosijiet, anewriżmi, eċċ.).
An increased incidence of thrombotic vascular events (see section 4.4 and section 4.8 - General) has been observed in patients receiving erythropoietic agents.
10 Inċidenza akbar ta ’ episodji trombotiċi vaskulari (ara sezzjoni 4. 4 u sezzjoni 4. 8 – Ġenerali) kienet osservata f’ pazjenti li kienu qed jirċievu mediċini eritropojetiċi.
10 The apparent molecular weight of erythropoietin is 32,000-40,000 Dalton.
Il- massa molekulari apparenti ta ’ eritropojetin hija ta ’ 32000- 40000 Dalton.
In two l arge, open-label studies, 2697 cancer patients receiving non-platinum chemotherapy were included, 1895 with solid tumours (683 breast, 260 lung, 174 gynaecological, 300 gastrointestinal, and 478 other tumour types) and 802 with haematological malignancies.
F’ żewġ studji kbar bit- tikketti miftuħa (open label), 2697 pazjent tal- kanċer li qegħdin jirċievu kimoterapija mhux tal- platinu ġew inklużi, 1895 b’ tumuri solidi (683 tas- sider, 260 tal- pulmun, 174 ġinekoloġiku, 300 gastro- intestinali, u 478 tipi oħra ta ’ tumri) u 802 b’ kankri mallinni emotalogiċi.
In a prospective, randomised, double-blind, placebo-controlled trial conducted in 375 anaemic patients with various non-myeloid malignancies receiving non-platinum chemotherapy, there was a significant reduction of anaemia-related sequelae (e.g. fatigue, decreased energy, and activity reduction), as measured by the following instruments and scales:
F’ prova prospettiva, randomised, double- blind, plaċebo- kontrollata magħmula fi 375 pazjent anemiċi b’ kankri mallinni varji mhux myeloid li qed jirċievu l- kimoterapija mhux tal- platinu, kien hemm tnaqqis sinjifikanti ta ’ sequelae relatati ma ’ l- anemija (eż. l- għejja, nuqqas ta ’ enerġija, u nuqqas ta ’
The studies either recruited patients who were being treated with chemotherapy (two studies) or used patient populations in which erythropoiesis stimulating agents are not indicated: anaemia in patients with cancer not receiving chemotherapy, and head and neck cancer patients receiving radiotherapy.
L- istudji jew inkludew pazjenti li kienu qed jiġu trattati b’ kimoterapija (żewġ studji) jew użaw popolazzjonijiet ta ’ pazjenti fejn sustanzi li jistimulaw l- eritropojesi ma kienux indikati: anemija f’ pazjenti bil- kanċer li ma kienux qed jirċievu kimoterapija, u pazjenti b’ kanċer fir ras u fil- għonq li kienu qed jirċievu radjoterapija.
The target haemoglobin concentration in two studies was > 13 g/dl; in the remaining three studies it was 12-14 g/dl.
Il- konċentrazzjoni ta ’ emoglobina immirata f’ żewġ studji kienet ta ’ > 13 g/ dl; fit- tliet studji li baqa ’ kienet ta ’ bejn 12- 14 g/ dl.
These studies have shown a consistent unexplained statistically significant excess mortality in patients who have anaemia associated with various common cancers who received recombinant human erythropoietin compared to controls.
Dawn l- istudji wrew mortalità eċċessiva konsistenti statistikament sinifikanti u bla spjegazzjoni f’ pazjenti li għandhom anemija assoċjata ma diversi kanċers komuni li rċevew eritropojetin rikombinanti uman meta mqabbel ma ’ kontrolli.
Overall survival outcome in the trials could not be statisfactorily explained by differences in the incidence of thrombosis and related complications between those given recombinant human erythropoietin and those in the control group.
Ir- riżultati ta ’ sopravivenza globali f’ dawn il- provi ma setgħux jiġu spjegati b’ mod sodisfaċenti bid- differenzi fl- inċidenza ta ’ trombożi u kumplikazzjonijiet relatati bejn dawk li jingħataw eritropojetin rikombinanti uman u dawk fil- grupp tal- kontroll.
Meta-analysis of overall survival data produced a hazard ratio point estimate of 1.08 in favour of controls (95% CI:
Meta- analiżi ta ’ l- informazzjoni dwar is- sopravivenza globali tat stima ta ’ punt ta ’ proporzjon ta ’ periklu ta ’ 1. 08 favur il- kontrolli (95% CI:
11 thromboembolic events in patients with cancer treated with recombinant human erythropoietin and a negative impact on overall survival cannot be excluded.
Hemm riskju ogħla għal każijiet tromboemboliċi f’ pazjenti b’ kanċer ittrattati b’ eritropojetin rikombinanti uman u impatt negattiv fuq is- sopravivenza globali ma tistax tiġi eskluża.
The extent to which these outcomes might apply to the administration of recombinant human erythropoietin to patients with cancer, treated with chemotherapy to achieve haemoglobin concentrations less than 13 g/dl, is unclear because few patients with these characteristics were included in the data reviewed.
Il- firxa li għalihom riżultati bħal dawn jistgħu japplikaw għall- għoti ta ’ eritropojetin rikombinanti uman għal pazjenti b’ kanċer, ittrattati b’ kimoterapija sabiex jintlaħqu konċentrazzjonijiet tal- emoglobina, ta ’ inqas minn 13 g/ dl, mhix ċara peress li kienu ftit il- pazjenti b’ dawn il- karatteristiċi li kienu inklużi fid- dejta riveduta.
The peak is always well below the peak achieved using the intravenous route (approximately 1/20th of the value).
L- ogħla punt huwa ferm anqas mill- ogħla punt miksub bl- użu tar- rotta IV (bejn wieħed u ieħor 1 f’ kull 20 tal- valur).