qanastek/EMEA-V3 huggingface dataset:
The re is no accumulation: the levels remain the same, whether they are determined 24 hours after the first injection or 24 hours after the last injection.
M’ hemmx akkumulazzjoni: il- livelli jibqgħu l- istess, kemm jekk huma determinati 24 siegħa wara l - ewwel injezzjoni sew jekk 24 siegħa wara l- aħħar injezzjoni.
In some pre-clinical toxicological studies in dogs and rats, but not in monkeys, erythropoietin therapy was associated with subclinical bone marrow fibrosis (bone marrow fibrosis is a known complication of chronic renal failure in humans and may be related to secondary hyperparathyroidism or unknown factors.
12 bl- eritropojetin kienet assoċjata ma ’ fibrożi sottoklinika tal- mudullun (il- fibrożi tal- mudullun hija kumplikazzjoni magħrufa ta ’ insuffiċjenza renali kronika fl- umani u tista ’ tkun relatata mal - hyperparathyroidism sekondarju jew fatturi mhux magħrufa.
Disodium phosphate dihydrate Sodium dihydrogen phosphate dihydrate Sodium chloride Calcium chloride dihydrate Polysorbate 20 Glycine
Disodium phosphate dihydrate Sodium dihydrogen phosphate dihydrate Sodium chloride Calcium chloride dihydrate Polysorbate 20 Glycine Leucine Isoleucine Threonine Glutamic acid Phenylalanine Water for injections Sodium hydroxide (għal aġġustament tal- pH) Hydrochloric acid (għal aġġustament tal- pH)
6.4 Special precautions for storage
6. 4 Prekawzjonijiet speċjali għall- ħażna Aħżen fi friġġ (2°C – 8°C).
For the purpose of ambulatory use, the patient may remove the product from the refrigerator and store it at room temperature (not above 25°C) for one single period of up to 3 days.
Għall- skop ta ’ użu ambulatorju, il- pazjent jista ’ jneħħi l- prodott mill- friġġ u jżommu f’ temperatura ambjentali (mhux aktar minn 25°C), għall- perjodu wieħed ta ’ mhux aktar minn tlett ijiem
Each pack contains 1 or 6 pre-filled syringes.
13 Kull pakett għandu 1 jew 6 siringi mimlija minn qabel.
Handling instructions for Silapo:
Struzzjonjiet tal- immaniġjar ta ’ Silapo:
Silapo must not be used if • The blister sealing is broken or the blister is damaged in any way. • The liquid is coloured or you can see particles floating in it. • Any liquid has leaked out of the pre-filled syringe or condensation is visible within the sealed blister. • It may have been accidentally frozen.
Silapo m’ għandux jintuża jekk • Is- siġill trasparenti jitkisser jew il- blister huwa b’ xi mod imħassar • Il- likwidu huwa kkulurit jew tista ’ tara l- partiċelli jgħumu fih • Jekk xi likwidu ħareġ mis- siringa mimlija minn qabel jew hija viżibbli l- kondensazzjoni fil - pakkett issiġġillat • Jista ’ ikun li kien ffriżat bi żball
13 Any unused product or waste material should be disposed of in accordance with local requirements.
Kull fdal tal- prodott li ma jkunx intuża jew skart li jibqa ’ wara l- użu tal- prodott għandu jintrema kif jitolbu l- liġijiet lokali.
Silapo 2000 IU/0.6ml solution for injection in pre-filled syringe
Silapo 2000 IU/ 0. 6 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.
15 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).
15 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).
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.
Haemoglobin variability should be addressed through dose management, with consideration for the haemoglobin target range of 10 g/dL (6.2 mmol/l) to 12 g/dl (7.5 mmol/l).
Il- varjabilità tal - emoglobina għandha tiġi indirizzata permezz tal- ġestjoni tad- doża, b’ kunsiderazzjoni għal medda mmirata għall- emoglobina ta ’ bejn 10 g/ dL (6. 2 mmol/ l) sa 12 g/ dl (7. 5 mmol/ l)
A sustained haemoglobin level of greater than 12 g/dl should be avoided; guidance for appropriate dose adjustment for when haemoglobin values exceeding 12 g/dl (7.5 mmol/l) are observed are described below.
Livell sostnut tal- emoglobina ta ’ mhux aktar minn 12 g/ dl għandu jiġi evitat; gwida għal aġġustament tad- doża għal meta l- valuri tal- emoglobina jaqbżu 12 g/ dl (7. 5 mmol/ l) jiġu osservati huma deskritti hawn isfel.
A rise in haemoglobin of greater than 2 g/dL (1.25 mmol/l) over a four week period should be avoided.
Għandu jiġi evitat li jkun hemm żieda fil- livell tal- emoglobina ta ’ aktar minn 2 g/ dL (1. 25 mmol/ l) fuq perijodu ta ’ erba ’ ġimgħat.
50 IU/kg 3 times per week by the intravenous route.
50 IU/ kg 3 darbiet fil- ġimgħa, ġol- vina.
At each step, the increase or reduction in dose should be of 25 IU/kg 3 times per week.
F’ kull stadju, iż- żieda jew tnaqqis fid- doża għandu jkun ta ’ 25 IU/ kg 3 darbiet fil- ġimgħa.
Hb between 10 and 12 g/dl (6.2-7.5 mmol/l).
Hb bejn l- 10 u t- 12 g/ dl (6. 2- 7. 5 mmol/ l).
The recommended total weekly dose is between 75 and 300 IU/kg by the intravenous route.
Id- doża rrakkomandata fil- ġimgħa hija ta ’ bejn il- 75 u t- 300 IU/ kg, ġol- vina.
The clinical data available suggest that those patients whose initial haemoglobin is very low (< 6 g/dl or < 3.75 mmol/l) may require higher maintenance doses than those whose initial anaemia is less severe (Hb > 8 g/dl or > 5 mmol/l).
Id- data klinika tagħti x’ tifhem li dawk il- pazjenti li l- emoglobina inizjali tagħhom hija baxxa ħafna (< 6 g/ dl or < 3. 75 mmol/ l) jista ’ jkun li jkollhom bżonn dożi ta ’ manteniment ogħla minn dawk li l - anemija inizjali tagħhom hija anqas severa (Hb > 8 g/ dl or > 5 mmol/ l).
50 IU/kg, 3 times per week by the intravenous route.
50 IU/ kg, 3 darbiet fil- ġimgħa ġol- vina.
When a dose adjustment is necessary, this should be done in steps of 25 IU/kg, 3 times per week at intervals of at least 4 weeks until the desired goal is achieved.
Meta aġġustament fid- doża huwa, neċessarju, dan dan għandu jsir fi stadji ta ’ 25 IU/ kg, 3 darbiet fil - ġimgħa f’ intervalli ta ’ mill- anqas 4 gimgħat sakemm l- iskop mixtieq jintlaħaq.
Hb between 9.5 and 11 g/dl (5.9-6.8 mmol/l).
Hb bejn id- 9. 5 u l- 11 g/ dl (5. 9- 6. 8 mmol/ l).
Dose (IU/kg given 3x week)
16 Doża (UI/ kg mogħtija 3x fil- ġimgħa)
Weight (kg) < 10 10-30 > 30
Toqol (kg) < 10 10- 30 > 30
16 The clinical data available suggest that those patients whose initial haemoglobin is very low (< 6.8 g/dl or < 4.25 mmol/l) may require higher maintenance doses than those whose initial haemoglobin is higher > 6.8 g/dl or > 4.25 mmol/l).
Id- data klinika provduta tagħti x’ tifhem li dawk il- pazjenti li l- emoglobina inizjali tagħhom hija baxxa ħafna (< 6. 8 g/ dl jew < 4. 25 mmol/ l) jista ’ jkun li jkollhom bżonn dożi ta ’ manteniment ogħla minn dawk li l- emoglobina inizjali tagħhom hija ogħla minn > 6. 8 g/ dl jew > 4. 25 mmol/ l).
Starting dose of 50 IU/kg 2 times per week by the intravenous route.
Doża tal- bidu ta ’ 50 IU/ kg 2 fil- ġimgħa, ġol- vina.
Hb between 10 and 12 g/dl (6.2-7.5 mmol/l).
(Hb bejn l- 10 u t- 12 g/ dl (6. 2- 7. 5 mmol/ l).
Maintenance dose between 25 and 50 IU/kg 2 times per week into 2 equal doses.
Doża ta ’ manteniment bejn il- 25 u l- 50 IU/ kg 2 fil- ġimħa f’ żewġ injezzjonijiet ugwali.
Starting dose of 50 IU/kg 3 times per week by the intravenous route, followed if necessary by a dose increase with 25 IU/kg increments (3 times per week) until the desired goal is achieved (this should be done in steps of at least four weeks).
Doża tal- bidu ta ’ 50 IU/ kg 3 darbiet fil- ġimgħa, ġol- vina, segwit jekk hemm bżonn minn żieda fid- dożi b’ 25 IU/ kg (3 darbiet fil- ġimgħa) sakemm l- għan mixtieq jintlaħaq (dan għandu jsir fi stadji ta’ minn ta ’ l - anqas erba ’ ġimgħat).
Maintenance dose between 17 and 33 IU/kg 3 times per week by the intravenous route.
Doża ta ’ manteniment bejn s- 17 u t- 33 IU/ kg 3 darbiet fil- ġimgħa, ġol- vina.
The maximum dose should not exceed 200 IU/kg 3 times per week.
Id- doża massima m’ għandhiex taqbeż il- 200 IU/ kg 3 darbiet fil- ġimgħa.
Treatment of patients with chemotherapy induced anaemia 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).
Haemoglobin variability should be addressed through dose management with consideration for the haemoglobin target range of 10 g/dl (6.2 mmol/l) to 12 g/dl (7.5 mmol/l).
Il- differenza tal- emoglobina għandha tiġi indirizzata permezz tal- ġestjoni tad- doża, b’ konsidrazzjoni għal medda mixtieqa għall - emoglobina ta ’ bejn 10 g/ dL (6. 2 mmol/ l) sa 12 g/ dl (7. 5 mmol/ l).
A sustained haemoglobin level of greater than 12 g/dl (7.5 mmol/l) should be avoided; guidance for appropriate dose adjustment for when haemoglobin values exceeding 12 g/dl (7.5 mmol/l) are observed are described below.
Livell sostnut ta ’ emoglobina ta ’ mhux aktar minn 12 g/ dl (7. 5 mmol/ l) għandu jiġi evitat; gwida għal aġġustament tad- doża għal meta l- valuri tal- emoglobina jaqbżu 12 g/ dl (7. 5 mmol/ l) jiġu osservati huma deskritti hawn isfel.
The initial dose is 150 IU/kg given subcutaneously 3 times per week.
Id- doża tal- bidu hija ta ’ 150 IU/ kg mogħtija taħt il- ġilda 3 darbiet fil- ġimgħa.
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.
If the haemoglobin has increased by at least 1 g/dl (0.62 mmol/l) or the reticulocyte count has increased ≥ 40,000 cells/µl above baseline after 4 weeks of treatment, the dose should remain at 150 IU/kg 3 times per week or 450 IU/kg once weekly.
17 Jekk l- emoglobina żdiedet b’ minn ta ’ l- anqas 1 g/ dl (0. 62 mmol/ l) jew l- għadd tar- retikoloċiti żdiedet ≥ 40000 ċelluli/ µl ‘ il- fuq mil- linja bażi wara 4 ġimgħat ta ’ trattament, id- doża għanda tibqa ’ ta ’ 150 IU/ kg 3 darbiet fil- ġimgħa jew 450 IU/ kg darba fil- ġimgħa.
If the haemoglobin increase is < 1 g/dl (< 0.62 mmol/l) and the reticulocyte count has increased < 40,000 cells/µl above baseline, increase the dose to 300 IU/kg 3 times per week.
Jekk iż- żieda fl- emoglobina hija < 1 g/ dl (< 0. 62 mmol/ l) u l- għadd tar- retikoloċiti żdied < 40000 ċelluli/ µl ‘ il fuq mil- inja bażi, żid id- doża għal 300 IU/ kg 3 darbiet fil- ġimgħa.
If after an additional 4 weeks of therapy at 300 IU/kg 3 times per week, the haemoglobin has increased ≥ 1 g/dl (0.62 mmol/l) or the reticulocyte count has increased ≥ 40,000 cells/µl the dose should remain at 300 IU/kg 3 times per week.
Jekk wara 4 ġimgħat oħra ta ’ terapija ta ’ 300 IU/ kg 3 darbiet fil - ġimgħa, l- emoglobina żdiedet ≥ 1 g/ dl (0. 62 mmol/ l) jew l- għadd tar- retikoloċiti żdied ≥ 40000 ċelluli/ µl id- doża għanda tibqa ’ ta ’ 300 IU/ kg 3 darbiet fil- ġimgħa.
However, if the haemoglobin has increased < 1 g/dl (< 0.62 mmol/l) and the reticulocyte count has increased < 40,000 cells/µl above baseline, response is unlikely and treatment should be discontinued.
Madankollu, jekk l- emoglobina żdiedet < 1 g/ dl (< 0. 62 mmol/ l) u l- għadd tar- retikoloċiti żdied < 40000 ċelluli/ µl il fuq mil- linja bażi, ir- rispons huwa dubjuż u t- trattament m’ għandux jitkompla.
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
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.
18 Intravenous injection The dose should be administered over at least 1-5 minutes, depending on the total dose.
Injezzjoni fil- vini Id- doża għandha tingħata fuq medda ta ’ mill- anqas 5 minuti, skond id- doża sħiħa.
A lternatively, the injection can be given at the end of the dialysis session via the fistula needle tubing, followed by 10 ml of sodium chloride 9 mg/ml (0.9%) solution for injection to rinse the tubing and ensure satisfactory injection of the medicinal product into the circulation.
B’ mod alternattiv, l- injezzjoni tista ’ tingħata fit- tmiem tas- sessjoni tad - dijalisi permezz ta ’ tubi tal- labra fistla, segwit minn 10 ml ta ’ soluzzjoni għall- injezzjoni ta ’ sodium chloride 9 mg/ ml (0. 9%) biex tlaħlaħ it- tubi u tassigura injezzjoni sodisfaċenti tal- prodott fiċ - ċirkolazzjoni.
A slower injection is preferable in patients who react to the treatment with “flu-like” symptoms.
Injezzjoni aktar bil- mod hija aktar mixtieqa f’ pazjenti li jirreaġixxu għat- trattament b’ sintomi “ qishom tal- influwenza ”.
General
19 Ġenerali
In order to ensure optimum response to erythropoietin, adequate iron stores should be assured: − iron supplementation, e.g.
Sabiex jiġi assigurat rispons ottimali għall- eritropojetin, ammonti adegwati ta ’ ħadid fil- ġsem għadhom jiġu assigurati: − Supplementazzjoni bil- ħadid, e. g.
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 − oral iron substitution of 200-300 mg/day is recommended for all cancer patients whose transferrin saturation is below 20%.
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%
19 All of these additive factors of anaemia should also be carefully considered when deciding to increase the dose of erythropoietin in cancer patients.
Dawn il- fatturi kollha flimkien tal- anemija għandhom jiġi kkunsidrati mill- qrib meta wieħed ikun qed jiddeċiedi d- doża ta ’ eritropojetin fil- pazjenti bil- kanċer.
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free’.
Dan il- prodott mediċinali fih anqas minn 1 mmol ta ’ sodju (23 mg) kull doża, i. e. essenzjalment ‘ bla sodju ’.
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.
In clinical trials, an increased risk of death and serious cardiovascular events was observed when erythropoiesis stimulating agents (ESAs) were administered to target a haemoglobin of greater than 12 g/dl (7.5 mmol/l).
Fi provi kliniċi, riskju ogħla ta ’ mewt u każijiet kardjovaskulari serji kienu osservati meta sustanzi li jistimulaw l- eritropojesi (ESAs) ġew mogħtija sabiex jintlaħaq livell ta ’ emoglobina li hu ogħla minn 12 g/ dl (7. 5 mmol/ l).
The rate of increase in haemoglobin should be approximately 1 g/dl (0.62 mmol/l) per month and should not exceed 2 g/dl (1.25 mmol/l) per month to minimize the risk of developing or worsening of hypertension.
Ir- rata fiż- żieda tal- emoglobina għanda tkun bejn wieħed u ieħor ta ’ 1 g/ dl (0. 62 mmol/ l) kull xahar u m’ għandiex taqbeż iż- 2 g/ dl (1. 25 mmol/ l) kull xahar sabiex jitnaqqas ir - riskju li tiżviluppa jew tiżdied il- pressjoni għolja.
Non response to erythropoietin therapy should prompt a search for causative factors.
20 In- nuqqas ta ’ rispons għat- terapija bl- eritropojetin għandu iwassal għal tfitxxija ta ’ fatturi kawżattivi.
In patients developing sudden lack of efficacy, defined by a decrease in haemoglobin (1-2 g/dl per month) with increased need for transfusions, a reticulocyte count should be obtained and typical causes of non-response (e.g. iron, folate, or Vitamin B12-deficiency, aluminium intoxication, infection or inflammation, blood loss, and haemolysis) should be investigated.
F’ pazjenti li juru nuqqas f’ daqqa ta ’ effikaċja, li tidher permezz ta ’ nuqqas fl- emoglobina (1- 2 g/ dl per month) b’ żieda ta ’ bżonn ta ’ trasfużjonijiet, l- għadd tar- retikuloċiti għandu jittieħed u kawżi tipiċi ta ’ nuqqas ta ’ rispons (eż defiċjenza fil- ħadid, folate jew il- Vitamina B12, intossikament bl- alumilju, infezzjoni jew infjammazzjoni, telf ta ’ demm, u emolisi) għandhom jiġu investigati.
20 electrolytes should be monitored in chronic renal failure patients.
L- elettroliti fis- serum għandhom jiġu mmoniterjati f’ pazjenti b ’ insuffiċjenza renali kronika.
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.
21 It- twissijiet u l- prekawzjonijiet speċjali assoċjati ma ’ programmi ta ’ pre- donazzjonijiet awtoloġi, speċjalment bdil ta ’ rutina fil- volum, għandhom jiġu rispettati.
In controlled clinical studies, use of Epoetin alfa and other erythropoiesis-stimulating agents (ESAs) have shown: • shortened time to tumour progression in patients with advanced head and neck cancer receiving radiation therapy when administered to target a haemoglobin of greater than 14 g/dl (8.7 mmol/l), • shortened overall survival and increased deaths attributed to disease progression at 4 months in patients with metastatic breast cancer receiving chemotherapy when administered to target a haemoglobin of 12-14 g/dl (7.5 -8.7 mmol/l), • 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.
Silapo has no or negligible influence on the ability to drive and use machines.
22 Silapo m’ għandux jew għandu ftit li xejn effett fuq il- ħila biex issuq u tħaddem magni.
22 Antibody-mediated erythroblastopenia (PRCA) has been reported after months to years of treatment with epoetin alfa.
Eritroblastopenja medjata mill- antikorpi (PRCA) ġiet irrappurtata wara perijodu ta ’ minn xhur sa snin ta ’ kura b’ epoetin alfa.
An increased incidence of thrombotic vascular events (see section 4.4 and section 4.8 - General) has been observed in patients receiving erythropoietic agents.
23 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.
23 The biological efficacy of erythropoietin has been demonstrated in various animal models in vivo (normal and anaemic rats, polycythaemic mice).
l- efikaċija bijoloġika tal- eritropojetin intweriet f’ diversi mudelli ta ’ l- annimali in vivo (ġrieden normali u anemiċi, ġrieden polycythaemic).
The re is an increased risk for 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.
24 5.2 Pharmacokinetic properties
5. 2 Tagħrif farmakokinetiku
In some pre-clinical toxicological studies in dogs and rats, but not in monkeys, erythropoietin therapy was associated with subclinical bone marrow fibrosis (bone marrow fibrosis is a known complication of chronic renal failure in humans and may be related to secondary hyperparathyroidism or unknown factors.
25 bl- eritropojetin kienet assoċjata ma ’ fibrożi sottoklinika tal- mudullun (il- fibrożi tal- mudullun hija kumplikazzjoni magħrufa ta ’ insuffiċjenza renali kronika fl- umani u tista ’ tkun relatata mal - hyperparathyroidism sekondarju jew fatturi mhux magħrufa.
Each pre-filled syringe contains 0.6 ml solution for injection.
Kull siringa mimlija minn qabel fiha 0. 6 ml ta ’ soluzzjoni għall- injezzjoni.
Each pack contains 1 or 6 pre-filled syringes.
26 Kull pakett għandu 1 jew 6 siringi mimlija minn qabel.
26 STADA Arzneimittel AG Stadastrasse 2-18 D-61118 Bad Vilbel Germany
STADA Arzneimittel AG Stadastrasse 2- 18 D- 61118 Bad Vilbel Il- Ġermanja
Silapo 3000 IU/0.9ml solution for injection in pre-filled syringe
Silapo 3000 IU/ 0. 9 ml soluzzjoni għall- injezzjoni f’ siringa mimlija minn qabel
28 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).
28 4. 4) 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).
Dose (IU/kg given 3x week)
29 Doża (UI/ kg mogħtija 3x fil- ġimgħa)
29 The clinical data available suggest that those patients whose initial haemoglobin is very low (< 6.8 g/dl or < 4.25 mmol/l) may require higher maintenance doses than those whose initial haemoglobin is higher > 6.8 g/dl or > 4.25 mmol/l).
Id- data klinika provduta tagħti x’ tifhem li dawk il- pazjenti li l- emoglobina inizjali tagħhom hija baxxa ħafna (< 6. 8 g/ dl jew < 4. 25 mmol/ l) jista ’ jkun li jkollhom bżonn dożi ta ’ manteniment ogħla minn dawk li l- emoglobina inizjali tagħhom hija ogħla minn > 6. 8 g/ dl jew > 4. 25 mmol/ l).
If the haemoglobin has increased by at least 1 g/dl (0.62 mmol/l) or the reticulocyte count has increased ≥ 40,000 cells/µl above baseline after 4 weeks of treatment, the dose should remain at 150 IU/kg 3 times per week or 450 IU/kg once weekly.
30 Jekk l- emoglobina żdiedet b’ minn ta ’ l- anqas 1 g/ dl (0. 62 mmol/ l) jew l- għadd tar- retikoloċiti żdiedet ≥ 40000 ċelluli/ µl ‘ il- fuq mil- linja bażi wara 4 ġimgħat ta ’ trattament, id- doża għanda tibqa ’ ta ’ 150 IU/ kg 3 darbiet fil- ġimgħa jew 450 IU/ kg darba fil- ġimgħa.
31 Intravenous injection The dose should be administered over at least 1-5 minutes, depending on the total dose.
Injezzjoni fil- vini Id- doża għandha tingħata fuq medda ta ’ mill- anqas 5 minuti, skond id- doża sħiħa.
General
32 Ġenerali
32 All of these additive factors of anaemia should also be carefully considered when deciding to increase the dose of erythropoietin in cancer patients.
Dawn il- fatturi kollha flimkien tal- anemija għandhom jiġi kkunsidrati mill- qrib meta wieħed ikun qed jiddeċiedi d- doża ta ’ eritropojetin fil- pazjenti bil- kanċer.
Non response to erythropoietin therapy should prompt a search for causative factors.
33 In- nuqqas ta ’ rispons għat- terapija bl- eritropojetin għandu iwassal għal tfitxxija ta ’ fatturi kawżattivi.
33 electrolytes should be monitored in chronic renal failure patients.
L- elettroliti fis- serum għandhom jiġu mmoniterjati f’ pazjenti b ’ insuffiċjenza renali kronika.
All special warnings and precautions associated with autologous predonation programs, especially routine volume replacement, should be respected.
34 It- twissijiet u l- prekawzjonijiet speċjali assoċjati ma ’ programmi ta ’ pre- donazzjonijiet awtoloġi, speċjalment bdil ta ’ rutina fil- volum, għandhom jiġu rispettati.
Silapo has no or negligible influence on the ability to drive and use machines.
35 Silapo m’ għandux jew għandu ftit li xejn effett fuq il- ħila biex issuq u tħaddem magni.
35 Antibody-mediated erythroblastopenia (PRCA) has been reported after months to years of treatment with epoetin alfa.
Eritroblastopenja medjata mill- antikorpi (PRCA) ġiet irrappurtata wara perijodu ta ’ minn xhur sa snin ta ’ kura b’ epoetin alfa.
An increased incidence of thrombotic vascular events (see section 4.4 and section 4.8 - General) has been observed in patients receiving erythropoietic agents.
36 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.
36 The biological efficacy of erythropoietin has been demonstrated in various animal models in vivo (normal and anaemic rats, polycythaemic mice).
l- efikaċija bijoloġika tal- eritropojetin intweriet f’ diversi mudelli ta ’ l- annimali in vivo (ġrieden normali u anemiċi, ġrieden polycythaemic).
37 5.2 Pharmacokinetic properties
5. 2 Tagħrif farmakokinetiku
In some pre-clinical toxicological studies in dogs and rats, but not in monkeys, erythropoietin therapy was associated with subclinical bone marrow fibrosis (bone marrow fibrosis is a known complication of chronic renal failure in humans and may be related to secondary hyperparathyroidism or unknown factors.
38 bl- eritropojetin kienet assoċjata ma ’ fibrożi sottoklinika tal- mudullun (il- fibrożi tal- mudullun hija kumplikazzjoni magħrufa ta ’ insuffiċjenza renali kronika fl- umani u tista ’ tkun relatata mal - hyperparathyroidism sekondarju jew fatturi mhux magħrufa.
Each pack contains 1 or 6 pre-filled syringes.
39 Kull pakett għandu 1 jew 6 siringi mimlija minn qabel.
Silapo 4000 IU/0.4ml solution for injection in pre-filled syringe
Silapo 4000 IU/ 0. 4 ml soluzzjoni għall- injezzjoni f’ siringa mimlija minn qabel
41 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).
41 4. 4) 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).
Dose (IU/kg given 3x week)
42 Doża (UI/ kg mogħtija 3x fil- ġimgħa)
42 The clinical data available suggest that those patients whose initial haemoglobin is very low (< 6.8 g/dl or < 4.25 mmol/l) may require higher maintenance doses than those whose initial haemoglobin is higher > 6.8 g/dl or > 4.25 mmol/l).
Id- data klinika provduta tagħti x’ tifhem li dawk il- pazjenti li l- emoglobina inizjali tagħhom hija baxxa ħafna (< 6. 8 g/ dl jew < 4. 25 mmol/ l) jista ’ jkun li jkollhom bżonn dożi ta ’ manteniment ogħla minn dawk li l- emoglobina inizjali tagħhom hija ogħla minn > 6. 8 g/ dl jew > 4. 25 mmol/ l).
− Adult patients with renal insufficiency not yet undergoing dialysis
− Pazjenti adulti b’ insuffiċjenza tal- kliewi li jkunu għadhom mhux qegħdin fuq id- dijalisi
If the haemoglobin has increased by at least 1 g/dl (0.62 mmol/l) or the reticulocyte count has increased ≥ 40,000 cells/µl above baseline after 4 weeks of treatment, the dose should remain at 150 IU/kg 3 times per week or 450 IU/kg once weekly.
43 Jekk l- emoglobina żdiedet b’ minn ta ’ l- anqas 1 g/ dl (0. 62 mmol/ l) jew l- għadd tar- retikoloċiti żdiedet ≥ 40000 ċelluli/ µl ‘ il- fuq mil- linja bażi wara 4 ġimgħat ta ’ trattament, id- doża għanda tibqa ’ ta ’ 150 IU/ kg 3 darbiet fil- ġimgħa jew 450 IU/ kg darba fil- ġimgħa.
In travenous injection The dose should be administered over at least 1-5 minutes, depending on the total dose.
Injezzjoni fil- vini Id- doża għandha tingħata fuq medda ta ’ mill- anqas 5 minuti, skond id- doża sħiħa.
General
45 Ġenerali
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 − oral iron substitution of 200-300 mg/day is recommended for all cancer patients whose
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%
Non response to erythropoietin therapy should prompt a search for causative factors.
46 In- nuqqas ta ’ rispons għat- terapija bl- eritropojetin għandu iwassal għal tfitxxija ta ’ fatturi kawżattivi.
All special warnings and precautions associated with autologous predonation programs, especially routine volume replacement, should be respected.
47 It- twissijiet u l- prekawzjonijiet speċjali assoċjati ma ’ programmi ta ’ pre- donazzjonijiet awtoloġi, speċjalment bdil ta ’ rutina fil- volum, għandhom jiġu rispettati.
Silapo has no or negligible influence on the ability to drive and use machines.
48 Silapo m’ għandux jew għandu ftit li xejn effett fuq il- ħila biex issuq u tħaddem magni.
An increased incidence of thrombotic vascular events (see section 4.4 and section 4.8 - General) has been observed in patients receiving erythropoietic agents.
49 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.
In some pre-clinical toxicological studies in dogs and rats, but not in monkeys, erythropoietin therapy was associated with subclinical bone marrow fibrosis (bone marrow fibrosis is a known complication of chronic renal failure in humans and may be related to secondary hyperparathyroidism or unknown factors.
51 bl- eritropojetin kienet assoċjata ma ’ fibrożi sottoklinika tal- mudullun (il- fibrożi tal- mudullun hija kumplikazzjoni magħrufa ta ’ insuffiċjenza renali kronika fl- umani u tista ’ tkun relatata mal - hyperparathyroidism sekondarju jew fatturi mhux magħrufa.
Each pack contains 1 or 6 pre-filled syringes.
52 Kull pakett għandu 1 jew 6 siringi mimlija minn qabel.
52 Stadastrasse 2-18 D-61118 Bad Vilbel Germany
STADA Arzneimittel AG Stadastrasse 2- 18 D- 61118 Bad Vilbel Il- Ġermanja
Silapo 5000 IU/0.5ml solution for injection in pre-filled syringe
Silapo 5000 IU/ 0. 5 ml soluzzjoni għall- injezzjoni f’ siringa mimlija minn qabel
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).
54 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).
Dose (IU/kg given 3x week)
55 Doża (UI/ kg mogħtija 3x fil- ġimgħa)
The clinical data available suggest that those patients whose initial haemoglobin is very low (< 6.8 g/dl or < 4.25 mmol/l) may require higher maintenance doses than those whose initial haemoglobin is higher > 6.8 g/dl or > 4.25 mmol/l).
Id- data klinika provduta tagħti x’ tifhem li dawk il- pazjenti li l- emoglobina inizjali tagħhom hija baxxa ħafna (< 6. 8 g/ dl jew < 4. 25 mmol/ l) jista ’ jkun li jkollhom bżonn dożi ta ’ manteniment ogħla minn dawk li l- emoglobina inizjali tagħhom hija ogħla minn > 6. 8 g/ dl jew > 4. 25 mmol/ l).
If the haemoglobin has increased by at least 1 g/dl (0.62 mmol/l) or the reticulocyte count has increased ≥ 40,000 cells/µl above baseline after 4 weeks of treatment, the dose should remain at 150 IU/kg 3 times per week or 450 IU/kg once weekly.
56 Jekk l- emoglobina żdiedet b’ minn ta ’ l- anqas 1 g/ dl (0. 62 mmol/ l) jew l- għadd tar- retikoloċiti żdiedet ≥ 40000 ċelluli/ µl ‘ il- fuq mil- linja bażi wara 4 ġimgħat ta ’ trattament, id- doża għanda tibqa ’ ta ’ 150 IU/ kg 3 darbiet fil- ġimgħa jew 450 IU/ kg darba fil- ġimgħa.
General
58 Ġenerali
Non response to erythropoietin therapy should prompt a search for causative factors.
59 In- nuqqas ta ’ rispons għat- terapija bl- eritropojetin għandu iwassal għal tfitxxija ta ’ fatturi kawżattivi.
All special warnings and precautions associated with autologous predonation programs, especially routine volume replacement, should be respected.
60 It- twissijiet u l- prekawzjonijiet speċjali assoċjati ma ’ programmi ta ’ pre- donazzjonijiet awtoloġi, speċjalment bdil ta ’ rutina fil- volum, għandhom jiġu rispettati.
Tumour growth potential Epoetins are growth factors that primarily stimulate red blood cell production.
L- epoetini huma fatturi ta ’ l- iżvilupp li prinċipalment jistimulaw il- produzzjoni ċ- ċelluli l- ħomor tad- demm.
Silapo has no or negligible influence on the ability to drive and use machines.
61 Silapo m’ għandux jew għandu ftit li xejn effett fuq il- ħila biex issuq u tħaddem magni.
An increased incidence of thrombotic vascular events (see section 4.4 and section 4.8 - General) has been observed in patients receiving erythropoietic agents.
62 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.
62 The apparent molecular weight of erythropoietin is 32,000-40,000 Dalton.
Il- massa molekulari apparenti ta ’ eritropojetin hija ta ’ 32000- 40000 Dalton.
63 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.
In some pre-clinical toxicological studies in dogs and rats, but not in monkeys, erythropoietin therapy was associated with subclinical bone marrow fibrosis (bone marrow fibrosis is a known complication of chronic renal failure in humans and may be related to secondary hyperparathyroidism or unknown factors.
64 bl- eritropojetin kienet assoċjata ma ’ fibrożi sottoklinika tal- mudullun (il- fibrożi tal- mudullun hija kumplikazzjoni magħrufa ta ’ insuffiċjenza renali kronika fl- umani u tista ’ tkun relatata mal - hyperparathyroidism sekondarju jew fatturi mhux magħrufa.
Each pack contains 1 or 6 pre-filled syringes.
65 Kull pakett għandu 1 jew 6 siringi mimlija minn qabel.
65 Any unused product or waste material should be disposed of in accordance with local requirements.
Kull fdal tal- prodott li ma jkunx intuża jew skart li jibqa ’ wara l- użu tal- prodott għandu jintrema kif jitolbu l- liġijiet lokali.
Silapo 6000 IU/0.6ml solution for injection in pre-filled syringe
Silapo 6000 IU/ 0. 6 ml soluzzjoni għall- injezzjoni f’ siringa mimlija minn qabel
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).
67 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).
Dose (IU/kg given 3x week)
68 Doża (UI/ kg mogħtija 3x fil- ġimgħa)
If the haemoglobin has increased by at least 1 g/dl (0.62 mmol/l) or the reticulocyte count has increased ≥ 40,000 cells/µl above baseline after 4 weeks of treatment, the dose should remain at 150 IU/kg 3 times per week or 450 IU/kg once weekly.
69 Jekk l- emoglobina żdiedet b’ minn ta ’ l- anqas 1 g/ dl (0. 62 mmol/ l) jew l- għadd tar- retikoloċiti żdiedet ≥ 40000 ċelluli/ µl ‘ il- fuq mil- linja bażi wara 4 ġimgħat ta ’ trattament, id- doża għanda tibqa ’ ta ’ 150 IU/ kg 3 darbiet fil- ġimgħa jew 450 IU/ kg darba fil- ġimgħa.
General
71 Ġenerali
Non response to erythropoietin therapy should prompt a search for causative factors.
72 In- nuqqas ta ’ rispons għat- terapija bl- eritropojetin għandu iwassal għal tfitxxija ta ’ fatturi kawżattivi.
All special warnings and precautions associated with autologous predonation programs, especially routine volume replacement, should be respected.
73 It- twissijiet u l- prekawzjonijiet speċjali assoċjati ma ’ programmi ta ’ pre- donazzjonijiet awtoloġi, speċjalment bdil ta ’ rutina fil- volum, għandhom jiġu rispettati.
In controlled clinical studies, use of Epoetin alfa and other erythropoiesis-stimulating agents (ESAs) have shown: • shortened time to tumour progression in patients with advanced head and neck cancer receiving radiation therapy when administered to target a haemoglobin of greater than 14 g/dl (8.7 mmol/l), • shortened overall survival and increased deaths attributed to disease progression at 4 months in patients with metastatic breast cancer receiving chemotherapy when administered to target a haemoglobin of 12-14 g/dl (7.5 -8.7 mmol/l),
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.
Silapo has no or negligible influence on the ability to drive and use machines.
74 Silapo m’ għandux jew għandu ftit li xejn effett fuq il- ħila biex issuq u tħaddem magni.
The se increases in blood pressure can be treated with medicinal products.
Dawn iż- żidiet fil- pressjoni tad- demm jistgħu jiġu kkurati bi prodotti mediċinali.
An increased incidence of thrombotic vascular events (see section 4.4 and section 4.8 - General) has been observed in patients receiving erythropoietic agents.
75 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.
The refore, routine volume replacement should be performed in such patients.
Għalhekk, għandu jkun hemm tibdil ta ’ rutina fil- volum f’ dawn il- pazjenti.
The extent to which these outcomes might
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.
76 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.
In some pre-clinical toxicological studies in dogs and rats, but not in monkeys, erythropoietin therapy was associated with subclinical bone marrow fibrosis (bone marrow fibrosis is a known complication of chronic renal failure in humans and may be related to secondary hyperparathyroidism or unknown factors.
77 bl- eritropojetin kienet assoċjata ma ’ fibrożi sottoklinika tal- mudullun (il- fibrożi tal- mudullun hija kumplikazzjoni magħrufa ta ’ insuffiċjenza renali kronika fl- umani u tista ’ tkun relatata mal - hyperparathyroidism sekondarju jew fatturi mhux magħrufa.
For the purpose of ambulatory use, the patient may remove the product from the refrigerator and store it at room temperature (not above 25°C) for one single period of up to 3 days.
Għall- skop ta ’ użu ambulatorju, il- pazjent jista ’ jneħħi l- prodott mill- friġġ u jżommu f’ temperatura ambjentali (mhux aktar minn 25°C), għall- perjodu wieħed ta ’ mhux aktar minn tlett ijiem 6. 5 In- natura tal- kontenitur u ta ’ dak li hemm ġo fih
Each pack contains 1 or 6 pre-filled syringes.
78 Kull pakett għandu 1 jew 6 siringi mimlija minn qabel.
Silapo 8000 IU/0.8ml solution for injection in pre-filled syringe
Silapo 8000 IU/ 0. 8 ml soluzzjoni għall- injezzjoni f’ siringa mimlija minn qabel
4.1 Therapeutic indications − 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.
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).
80 4. 4) 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).
Dose (IU/kg given 3x week)
81 Doża (UI/ kg mogħtija 3x fil- ġimgħa)
If the haemoglobin has increased by at least 1 g/dl (0.62 mmol/l) or the reticulocyte count has increased ≥ 40,000 cells/µl above baseline after 4 weeks of treatment, the dose should remain at 150 IU/kg 3 times per week or 450 IU/kg once weekly.
82 Jekk l- emoglobina żdiedet b’ minn ta ’ l- anqas 1 g/ dl (0. 62 mmol/ l) jew l- għadd tar- retikoloċiti żdiedet ≥ 40000 ċelluli/ µl ‘ il- fuq mil- linja bażi wara 4 ġimgħat ta ’ trattament, id- doża għanda tibqa ’ ta ’ 150 IU/ kg 3 darbiet fil- ġimgħa jew 450 IU/ kg darba fil- ġimgħa.
Alternatively, the injection can be given at the end of the dialysis session via the fistula needle tubing, followed by 10 ml of sodium chloride 9 mg/ml (0.9%) solution for injection to rinse the tubing and ensure satisfactory injection of the medicinal product into the circulation.
B’ mod alternattiv, l- injezzjoni tista ’ tingħata fit- tmiem tas- sessjoni tad - dijalisi permezz ta ’ tubi tal- labra fistla, segwit minn 10 ml ta ’ soluzzjoni għall- injezzjoni ta ’ sodium chloride 9 mg/ ml (0. 9%) biex tlaħlaħ it- tubi u tassigura injezzjoni sodisfaċenti tal- prodott fiċ - ċirkolazzjoni.
General
84 Ġenerali
These include: iron, folate, or Vitamin B12 deficiency; aluminium intoxication; intercurrent infections; inflammatory or traumatic episodes; occult blood loss; haemolysis, and bone marrow fibrosis of any origin.
85 Dawn jinkludu: deifiċjenza fil- ħadid, fil- folate, jew fil- Vitamina B12; intossikazzjoni bl- aluminju; infezzjonijiet interkurrenti; episodji ta ’ infjammazzjoni jew trawmatiċi; telf ta ’ demm moħbi; emolisi, fibrożi tal- muddullun ta ’ kwalunkwe oriġini.