qanastek/EMEA-V3 huggingface dataset:
A decision on whether to continue/ discontinue breast-feeding or to continue/ discontinue therapy with filgrastim should be made taking into account the benefit of breast- feeding to the child and the benefit of filgrastim therapy to the woman.
Deċiżjoni jekk għandux jitkompla jew jitwaqqafx it- treddigħ jew titkomplix jew titwaqqafx il- kura b’ filgrastim għandha tittieħed billi jiġu meqjusa l- benefiċji tat- treddigħ għat- tarbija u l- benefiċji tal- kura b ’ filgrastim għall- omm.
Filgrastim has minor or moderate influence on the ability to drive and use machines.
Filgrastim għandu effett żgħir jew moderat fuq il- ħila biex issuq u tħaddem magni..
If the patient is experiencing fatigue, caution is advised when driving a car or operating machinery.
Jekk il- pazjent qed iħoss l- għeja, il- kawtela hija meħtieġa fis- sewqan ta ’ karozza jew fit- tħaddim ta ’ magni.
During clinical studies 541 cancer patients and 188 healthy volunteers were exposed to Biograstim.
Fi studji kliniċi, 541 pazjenti b’ kanċer u 188 volontiera f’ saħħithom ġew esposti għal Biograstim.
The safety profile of Biograstim observed in these clinical studies was consistent with that reported with the reference product used in these studies.
Il- profil ta ’ sigurta ’ ta ’ Biograstim li ġie osservat f’ dawn l- istudji kliniċi kien konsistenti ma dak tal- prodott ta ’ referenza li ntuża f’ dawn l- istudji.
The following undesirable effects and their frequencies have been observed under treatment with filgrastim based on published information.
L- effetti mhux mixtieqa li ġejjin u l- frekwenza tagħhom ġew osservati waqt kura b’ filgrastim u huma bbażati fuq informazzjoni ppublikata.
The assessment of undesirable effects is based on the following frequency data:
Il- frekwenzi ta ’ l- effetti mhux mixtieqa huma definiti fuq bażi ta ’ frekwenza kif ġej:
Very common:
10 Komuni ħafna:
Common:
Komuni:
Uncommon:
Mhux komuni:
Very rare:
Rari ħafna:
Not known:
Mhux magħruf:
≥ 1/ 10 ≥ 1/ 100, < 1/ 10 ≥ 1/ 1,000, < 1/ 100 ≥ 1/ 10,000, < 1/ 1,000 < 1/ 10,000 cannot be estimated from the available data
≥1/ 10 ≥1/ 100, < 1/ 10 ≥1/ 1, 000, < 1/ 100 ≥1/ 10, 000, < 1/ 1, 000 < 1/ 10, 000 ma tistax tittieħed stima mid- data disponibbli
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
frekwenza, l- effetti mhux mixtieqa għandhom jitniżżlu skond is- serjetà tagħhom;
In cancer patients
F’ pazjenti b’ kanċer
In clinical trials, the most frequent undesirable effects attributable to filgrastim at the recommended dose were mild or moderate musculoskeletal pain, occurring in 10%, and severe musculoskeletal pain in 3% of patients.
Fi provi kliniċi, l- effetti mhux mixtieqa l- aktar frekwenti relatati ma ’ l- użu ta ’ filgratim fid- dożi rakkomandati kienu uġigħ fl- għadam ħafif għal moderat, li seħħ f’ 10%, u uġigħ fl- għadam qawwi fi 3% tal- pazjenti.
Musculoskeletal pain is usually controlled with standard analgesics.
L- uġigħ fl- għadam huwa ġeneralment ikkontrollat b’ mediċini komuni kontra l- uġigħ.
Less frequent undesirable effects include urinary abnormalities predominantly mild or moderate dysuria.
Effetti mhux mixtieqa inqas frekwenti jinkludu disturbi fis- sistema urinarja, bl- effett predominanti jkun diżurja ħafif għal moderat.
In randomised, placebo-controlled clinical trials, filgrastim did not increase the incidence of undesirable effects associated with cytotoxic chemotherapy.
Fi studji kliniċi randomised ikkontrollati bil- plaċebo, filgrastim ma wassalx għal żjieda fl- inċidenza ta ’ effetti mhux mixtieqa assoċjati ma ’ kimoterapija ċitotossika.
Undesirable effects reported with equal frequency in patients treated with filgrastim/ chemotherapy and placebo/ chemotherapy included nausea and vomiting, alopecia, diarrhoea, fatigue, anorexia, mucositis, headache, cough, skin rash, chest pain, generalised weakness, sore throat, constipation and unspecified pain.
Effetti mhux mixtieqa li ġew irrapporti bl- istess frekwenza f’ pazjenti kkurati b’ filgrastim/ kimoterapija u b’ placebo/ kimoterapija jinkludu tqalligħ u rimettar, alopeċja, dijarreja, għeja, anoressija, mukożite, uġigħ ta ’ ras, sogħla, raxx fil- ġilda, uġigħ fis- sider, debbulizza, uġigħ fil- grieżem, stitikezza u uġigħ ġenerali.
10 Reversible, dose-dependent and usually mild or moderate elevations of lactate dehydrogenase (LDH), alkaline phosphatase, serum uric acid and gamma-glutamyltransferase (GGT) occurred with filgrastim in approximately 50%, 35%, 25%, and 10% of patients respectively, at recommended doses.
Żjidiet ħfief għal moderati, li reġgħu lura għan- normal, u li kienu dipendenti fuq id- doża, f’ lactate dehydrogenase (LDH), alkaline phosphatase, serum uric acid u gamma- glutamyltransferase (GGT), seħħu f’ madwar 50%, 35%, 25%, u 10% tal- pazjenti rispettivament, bl- użu ta ’ filgrastim bid- dożi rakkomandati.
Transient decreases in blood pressure, not requiring clinical treatment, have been reported occasionally.
Xi kultant ġiet irreppurtata tbaxxija transitorja fil- pressjoni tad- demm, li ma kelliex bżonn ta ’ kura medika.
Vascular disorders, including veno-occlusive disease and fluid volume disturbances, have been reported occasionally in patients undergoing high dose chemotherapy followed by autologous bone marrow transplantation.
Disturbi vaskolari, fosthom mard veno- okklussiv u disturbi fil- volum tal- fluwidi, ġew irrapportati xi kultant f’ pazjenti waqt kimoterapija b’ doża għolja segwit bit- trapjant awtologu tal- mudullun.
The causal association with filgrastim has not been established.
Ir- relazzjoni kawżali ma kura b ’ filgrastim ma ġietx stabbilita.
Very rare events of cutaneous vasculitis have been reported in patients treated with filgrastim.
Każijiet rari ħafna ta 'infjammazzjoni vaskulari fil- ġilda ġew osservati f' pazjenti li ngħataw filgrastim.
The mechanism of vasculitis in patients receiving filgrastim is unknown.
Il- mekkaniżmu ta 'l- infjammazzjoni vaskulari f' pazjenti li qed jirċievu filgrastim mhux magħruf.
The occurrence of Sweet's syndrome (acute febrile dermatosis) has been reported occasionally.
Ġew irrapportati xi każijiet tas- sindromu Sweet (dermatożi akuta u bid- deni).
However, since a significant percentage of these patients were suffering from leukaemia, a condition known to be associated with Sweet's syndrome, a causal relationship with filgrastim has not been established.
Madankollu, peress li perċentaġġ għoli ta ’ dawn il- pazjenti kienu qegħdin isofru minn lewkimja, kundizzjoni magħrufa li tkun assoċjata mas- sindromu Sweet, relazzjoni kawżali ma ’ filgrastim għada ma ġietx stabbilita.
Exacerbation of rheumatoid arthritis has been observed in individual cases.
Aggravament ta ’ artrite rewmatika kien osservat f ’ każijiet individwali.
Rare pulmonary undesirable effects including interstitial pneumonia, pulmonary oedema and pulmonary infiltrates have been reported in some cases with an outcome of respiratory failure or adult respiratory distress syndrome (ARDS) which may be fatal (see section 4.4).
Effetti mhux mixtieqa rari tal- pulmun, fosthom pulmonite interstizjali, edema pulmonari, ġew irrapportati fejn ftit minnhom irriżultaw f 'inkapaċità respiratorja jew sindromu tat- tbatija respiratorja fl- adulti (ARDS), li setgħu jkunu fatali (ara sezzjoni 4. 4)
Allergic Reactions:
Reazzjonijiet Allerġiċi:
Allergic-type reactions, including anaphylaxis, skin rash, urticaria, angioedema, dyspnoea and hypotension, occurring on initial or subsequent treatment, have been reported in patients receiving filgrastim.
Reazzjonijiet ta ’ allerġija, inklużi anafilassi, raxx tal- ġilda, urtikarja, anġjoedema, qtugħ ta 'nifs u pressjoni baxxa, li seħħew mal- bidu jew wara l- kura, ġew irrapportati f’ pazjenti li qed jirċievu l- filgrastim.
Overall, reports were more common after IV administration.
B’ kollox, ir- rapporti kienu iktar spissi wara l- amministrazzjoni ġol- vina.
In some cases, symptoms have recurred with rechallenge, suggesting a causal relationship.
Fi ftit każi, is- sintomi reġgħu seħħew hekk kif reġgħet bdiet tingħata l- kura, li b’ hekk tissuġġerixxi relazzjoni każwali.
Filgrastim should be permanently discontinued in patients who experience a serious allergic reaction.
Filgrastim għandu jitwaqqaf permanenti f' pazjenti li jkollhom reazzjoni allerġika serja.
Isolated cases of sickle cells crises have been reported in patients with sickle cell disease (see section 4.4).
11 Każijiet iżolati ta ’ kriżi tal- marda taċ- ċelluli Sickle ġew rapportati f’ pazjenti bil- marda taċ- ċelluli Sickle (ara sezzjoni 4. 4).
System organ class Metabolism and nutrition disorders
Disturbi fil- metaboliżmu u n- nutrizzjoni
Frequency Very common
Komuni ħafna
Undesirable effect Elevated alkaline phosphatase, elevated LDH, elevated uric acid
Żjieda fl- alkaline phosphatase, zjieda fil- LDH, żjieda fil- uric acid
Nervous system disorders Vascular disorders Respiratory, thoracic and mediastinal disorders Gastrointestinal disorders
Disturbi fis- sistema nervuża Disturbi vaskulari Disturbi respiratorji, toraċiċi u medjastinali Disturbi gastro- intestinali
Common Rare Common Very rare Very common Common
Komuni Rari Komuni Rari ħafna Komuni ħafna Komuni
Headache Vascular disorder Cough, sore throat Pulmonary infiltrates Nausea/ Vomiting Constipation, anorexia, diarrhoea, muscositis
Uġigħ ta ’ ras Disturb vaskulari Sogħla, uġigħ fil- grieżem Infiltrati pulmonari Tqalligħ/ rimettar Stitikezza, anoressija, dijarreja, mukożite
Hepatobiliary disorders Skin and subcutaneous tissue disorders
Disturbi fil- fwied u fil- marrara Disturbi fil- ġilda u fit- tessuti ta ’ taħt il- ġilda
Very common Common Very rare
Komuni ħafna Komuni Rari ħafna
Elevated GGT Alopecia, skin rash Sweet's syndrome, cutaneous vasculitis
Żjieda fil- GGT Alopeċja, raxx fil- ġilda Sindromu Sweet, infjammazzjoni vaskulari fil- ġilda
Musculoskeletal and connective tissue disorders
Disturbi muskolu- skeltrali u tat - tessut Konnettiv
Very common Very rare
Komuni ħafna Rari ħafna
Chest pain, musculoskeletal pain Rheumatoid arthritis exacerbation
Uġigħ fis- sider, uġigħ muskolu - skeltrali Aggravament tal- artrite rewmatika
Renal and urinary disorders General disorders and administration site conditions
Disturbi fil- kliewi u fis- sistema urinarja
Very rare Common Uncommon Very rare
Rari ħafna
Urinary abnormalities Fatigue, generalised weakness Unspecified pain Allergic reaction
Disturbi ġenerali u kondizzjonijiet ta ’ mnejn jingħata
11
Għeja, debbulizza Uġigħ ġenerali Reazzjoni allerġiku
In peripheral blood progenitor cell mobilisation in normal donors
F’ donaturi b’ saħħithom taħt proċedura ta ’ mobilizzazzjoni ta ’ PBPC
The most commonly reported undesirable effect was mild to moderate transient musculo-skeletal pain.
L- iktar effett mhux mixtieq li ġie rrapportat kien uġigħ muskolu- skeltrali ħafif għal moderat li kien reversibbli.
Leukocytosis (WBC > 50 x 109/ l) was observed in 41% of donors and transient thrombocytopenia (platelets < 100 x 109/ l) following filgrastim and leukapheresis was observed in 35% of donors.
Lewkoċitosi (WBC > 50 x 109/ l) ġie osservat f’ 41% tad- donaturi waqt li tromboċitopenja reversibbli (plejtlits < 100 x 109/ l) ġiet osservata f’ 35% tad- donaturi wara amministrazzjoni ta ’ filgrastim u lewkafereżi.
Transient, minor increases in alkaline phosphatase, LDH, SGOT (serum glutamic oxaloacetic transaminase) and uric acid have been reported in normal donors receiving filgrastim; these were without clinical sequelae.
Żjidiet ħfief, li reġgħu lura għan- normal, fl- alkaline phosphatase, LDH, SGOT (serum glutamic oxaloacetic transaminase) u uric acid kienu rrapportati f’ donaturi b’ saħħithom li rċievu filgrastim; dawn ma kellhomx effetti kliniċi assoċjati magħhom.
Exacerbation of arthritic symptoms has been observed very rarely.
Aggravament tas- sintomi tal- artrite kien osservat f’ każijiet rari ħafna.
Symptoms suggestive of severe allergic reactions have been reported very rarely.
Sintomi li jissuġġerixxu reazzjonijiet allerġiċi qawwija ġew rapportati f’ każijiet rari ħafna.
Headaches, believed to be caused by filgrastim, have been reported in PBPC donor studies.
Uġigħ ta ’ ras, maħsub li ġej minħabba l- filgrastim, ġie rapportat f’ studji fuq donaturi ta ’ PBPC.
Common but generally asymptomatic cases of splenomegaly and very rare cases of splenic rupture have been reported in healthy donors and patients following administration of G-CSFs (see section 4.4).
Każijiet komuni iżda ġeneralment mingħajr sintomi ta ’ tkabbir tal- milza u każijiet rari ħafna ta ’ milza mifqugħha ġew irrapurtati f’ donaturi b’ saħħithom u f’ pazjenti wara li ngħataw G- CSF.
System organ class Blood and lymphatic system disorders Metabolism and nutrition disorders
(ara sezzjoni 4. 4).
Frequency Very common Uncommon Common Uncommon
Effett mhux mixtieq Sistema tal- klassifika tal- organi
Undesirable effect Leukocytosis, thrombocytopenia Spleen disorder Elevated alkaline phosphatase, elevated LDH SGOT increased, hyperuricaemia
Frekwenza
Nervous system disorders Musculoskeletal and connective tissue disorders
Disturbi tad- demm u tas- sistema limfatika
Very common Very common Uncommon
Komuni ħafna Mhux komuni
General disorders and administration site conditions
Lewkoċitosi, tromboċitopenja Disturbi fil- milza
Undesirable effects related to filgrastim therapy in SCN patients have been reported and for some their frequencies tend to decrease with time.
Kien hemm rapporti ta ’ effetti mhux mixtieqa relatati ma ’ kura ta ’ filgrastim f’ pazjenti b’ SCNu, għal xi whud, il- frekwenza tagħhom kellha tendenza li tonqos maż- żmien.
The most frequent undesirable effects attributable to filgrastim were bone pain, and general musculoskeletal pain.
L- effetti mhux mixtieqa l- aktar frekwenti kkawżati minn filgrastim kienu uġigħ fl- għadam, u uġigħ muskolu- skeltrali ġenerali.
Other undesirable effects seen include splenic enlargement, which may be progressive in a minority of cases and thrombocytopenia.
Effetti mhux mixtieqa oħrajn osservati jinkludu tkabbir tal- milza li, fil- minoranza tal- każi, jista ’ jkun progressiv, u tromboċitopenja.
Headache and diarrhoea have been reported shortly after starting filgrastim therapy, typically in less than 10% of patients.
Uġigħ ta ’ ras u dijarreja ġew irrapportati ftit wara il- bidu ta ’ kura b’ filgrastim, tipikament f’ inqas minn 10% tal- pazjenti.
Anaemia and epistaxis have also been reported.
Anemija and epistassi wkoll ġew irrapportati.
Transient increases with no clinical symptoms were observed in serum uric acid, lactic dehydrogenase and alkaline phosphatase.
Ġew osservati żjidiet, li jerġgħu lura għan- normal, u mingħajr effetti kliniċi assoċjati, fil- uric acid, lactic dehydrogenase u alkaline phosphatase.
Transient, moderate decreases in non-fasting blood glucose have also been seen.
Tnaqqis moderat li jerġa lura għan- normal fil- livell non- fasting ta ’ glucose fid- demm ukoll ġie osservat.
Undesirable effects possibly related to filgrastim therapy and typically occurring in < 2% of SCN patients were injection site reaction, headache, hepatomegaly, arthralgia, alopecia, osteoporosis and rash.
Effetti mhux mixtieqa possibilment relatati ma ’ kura ta ’ filgrastim, u li tipikament seħħu f’ inqas minn 2% tal- pazjenti b’ newtropenja qawwija u kronika, kienu rejazzjonijiet fis- sit ta ’ injezzjoni, uġigħ ta ’ ras, epatomegalija, arthralgia, alopeċja, ostejoporosi u raxx.
During long term use, cutaneous vasculitis has been reported in 2% of SCN patients.
Meta ntuża fit- tul, infjammazzjoni vaskulari fil- ġilda giet irraportata fit- 2% tal- pazjenti b’ newtropenja qawwija u kronika.
There have been very few instances of proteinuria/ haematuria.
Każijiet ta ’ protejnurja/ ematurja kienu rari ħafna.
System organ class Blood and lymphatic system disorders
Disturbi tad- demm u tas- sistema limfatika
Frequency Very common Common Uncommon
Komuni ħafna Komuni Mhux komuni
Undesirable effect Anaemia, splenomegaly Thrombocytopenia Spleen disorder
Anemija, żjieda fid- daqs tal- milza Tromboċitopenja Disturbi fil- milza
Metabolism and nutrition disorders
Disturbi fil- metaboliżmu u n- nutrizzjoni
Very common
Komuni ħafna
Decreased glucose, elevated alkaline phosphatase, elevated LDH, hyperuricaemia
Tnaqqis fil- glucose, żjieda fl- alkaline phosphatase, żjieda fil- LDH, iperurikemija
Nervous system disorders Respiratory, thoracic and mediastinal disorders
Disturbi fis- sistema nervuża Disturbi respiratorji, toraċiċi u medjastinali
Common Very common
Komuni Komuni ħafna
Headache Epistaxis
Uġigħ ta ’ ras Epitassi
Gastrointestinal disorders Hepatobiliary disorders Skin and subcutaneous tissue disorders
Disturbi gastro- intestinali Disturbi fil- fwied u fil- marrara Disturbi fil- ġilda u fit- tessuti ta ’ taħt il- ġilda
Common Common Common
Komuni Komuni Komuni
Diarrhoea Hepatomegaly Alopecia, cutaneous vasculitis, injection site pain, rash
Dijarreja Epatomegalija Alopeċja, infjammazzjoni vaskulari fil- ġilda, injezzjoni site uġigħ fis- sit ta ’ injezzjoni, raxx
Musculoskeletal and connective tissue disorders Renal and urinary disorders
Disturbi muskolu- skeltrali u tat - tessut Konnettiv Disturbi fil- kliewi u fis- sistema
Very common Common Uncommon
Komuni ħafna Komuni Mhux komuni
Musculoskeletal pain Osteoporosis Haematuria, proteinuria
Uġigħ muskolu- skeltrali Ostejoporosi Ematurja, protejnurja
Frequency
urinarja
Blood and lymphatic system disorders
L- inċidenza ta ’ dawn il- każi kienet komparabbli ma dik irraportata f’ pazjenti b’ kanċer.
Common
Frekwenza
Spleen disorder
Disturbi tad- demm u tas- sistema Komuni limfatika
Musculoskeletal and connective tissue disorders
Disturbi fil- milza
Very common
Disturbi muskolu- skeltrali u tat - Komuni ħafna tessut Konnettiv
Musculoskeletal pain
Uġigħ muskolu- skeltrali
No case of overdose has been reported.
L- ebda każ ta ’ doża eċċessiva ma ġie rrapportat.
Discontinuation of filgrastim therapy usually results in a 50% decrease in circulating neutrophils within 1 to 2 days, with a return to normal levels in 1 to 7 days.
Il- waqfien mill- kura ta ’ filgrastim is- soltu jġib tnaqqis ta ’ 50% tan- newtrofili fid- demm fiż- żmien ġurnata jew tnejn, b’ ritorn għall- livelli normali fiż- żmien 1 sa 7 ijiem.
Pharmacotherapeutic group:
Kategorija farmakoterapewtika:
Colony stimulating factors, ATC code:
Fatturi li jistimolaw il- kolonji ta ’ granuloċiti, Kodiċi ATC:
Human G-CSF is a glycoprotein which regulates the production and release of functional neutrophils from the bone marrow.
Il- G- CSF uman huwa glikoproteina li tirregola l- produzzjoni u l- ħelsien ta ’ newtrofili mill- mudullun.
Biograstim containing r-metHuG-CSF (filgrastim) causes marked increases in peripheral blood neutrophil counts within 24 hours, with minor increases in monocytes.
Biograstim, li fih r- metHuG- CSF (filgrastim), jikkawża żjieda sinifikanti fl- għadd ta ’ newtrofili fid- demm periferali fi żmien 24 siegħa, b’ żjidiet minuri fil- monoċiti.
In some SCN patients, filgrastim can also induce a minor increase in the number of circulating eosinophils and basophils relative to baseline; some of these patients may present with eosinophilia or basophilia prior to treatment.
F’ xi każi ta ’ SCN, filgrastim jista ’ jikkawża wkoll żjieda żgħira mill- baseline fil- livelli ta ’ eżinofili u bażofili fid- demm; xi wħud minn dawn il- pazjenti jistgħu jippreżentaw b’ eżinofilja jew bażofilja qabel il- bidu ta ’ kura.
Elevations of neutrophil counts are dose-dependent at recommended doses.
Meta filgrastim jingħata fid- dożi rakkomandati, żjidiet fl- għadd ta ’ newtrofili huma dipendenti fuq id- doża.
Neutrophils produced in response to filgrastim show normal or enhanced function as demonstrated by tests of chemotactic and phagocytic function.
In- newtrofili li jiġu prodotti b’ rispons għal kura b’ filgrastim juru funzjonalita’ normali jew miżjuda, kif intwera b’ analiżi li saru fuq il- funzjoni kimotattika u fagoċitika.
Following termination of filgrastim therapy, circulating neutrophil counts decrease by 50% within 1 to 2 days, and to normal levels within 1 to 7 days.
Wara il- waqfien mill- kura ta ’ filgrastim, l- għadd ta ’ newtrofili fid- demm jonqos b ’ 50% fiż- żmien ġurnata 1 jew 2, b’ ritorn għall- livelli normali fiż- żmien 1 sa 7 ijiem.
Use of filgrastim in patients undergoing cytotoxic chemotherapy leads to significant reductions in the incidence, severity and duration of neutropenia and febrile neutropenia.
L- użu ta ’ filgrastim f’ pazjenti waqt kimoterapija ċitotossika jwassal għal tnaqqis sinifikanti fl- inċidenza, fis- severita ’ u fid- dewmien ta ’ newtropenja u newtropenja bid- deni.
Treatment with filgrastim significantly reduces the duration of febrile neutropenia, antibiotic use and hospitalisation after induction chemotherapy for acute myelogenous leukaemia or myeloablative therapy followed by bone marrow transplantation.
Kura b’ filgrastim iwassal għal tnaqqis sinifikament fid- dewmien ta ’ newtropenja bid- deni, l- użu ta ’ antibijotiċi u dħul fl- isptar wara induzzjoni ta ’ kimoterapija għal lewkimja majeloġenika akuta jew kura majeloablativa segwit bit- trapjant tal- mudullun.
The incidence of fever and documented infections were not reduced in either setting.
L- inċidenza ta ’ deni u n- numru ta’ infezzjonijiet reġistrati ma tnaqqsux fl- ebda ċirkostanza.
The duration of fever was not reduced in patients undergoing myeloablative therapy followed by bone marrow transplantation.
Ma kienx hemm tnaqqis fid- dewmien ta ’ deni f’ pazjenti waqt li kienu qed jingħataw kura majeloablativa segwit bit- trapjant tal- mudullun.
Use of filgrastim, either alone or after chemotherapy, mobilises haematopoietic progenitor cells into peripheral blood.
14 L- użu ta ’ filgrastim, waħdu jew wara kimoterapija, jimmobilizza ċ- celluli proġenitriċi ematopojetiċi għal ġod- demm periferiku.
These autologous PBPCs may be harvested and infused after high-dose cytotoxic therapy, either in place of or in addition to bone marrow transplantation.
Dawn iċ- ċelluli awtologi jistgħu jinġabbru u jerġgħu jiġu infużi wara terapija ċitotossika ta’ doża għolja, flok jew flimkien ma ’ trapjant tal- mudullun.
Infusion of PBPCs accelerates haematopoietic recovery reducing the duration of risk for haemorrhagic complications and the need for platelet transfusions.
Infużjoni biċ- ċelluli proġentriċi tad- demm iħaffef ir- ritorn ematopojetiku għan- normalita ’ u b’ hekk jitnaqqas ir- riskju ta ’ episodji emorraġiċi u l- bżonn ta ’ trasfużjonijiet tal- plejtlets.
Recipients of allogeneic PBPCs mobilised with filgrastim experienced significantly more rapid haematological recovery, leading to a significant decrease in time to unsupported platelet recovery, when compared with allogeneic bone marrow transplantation.
Reċipjenti ta ’ ċelluli proġenitriċi tad- demm periferali alloġeniku, li ġew mobilizzati b’ filgrastim, damu sinifikament inqas biex jirkupraw ematoloġikament, b’ konsegwenza li l- ħin meħud għal irkupru tal - plejtlits mingħajr appoġġ kien sinifikament anqas, meta kkomparat ma ’ trapjant tal- mudullun alloġeniku.
Prior to allogeneic PBPC transplantation, use of filgrastim for the mobilisation of PBPC in normal donors allows a collection of 4 x 106 CD34+ cells/ kg recipient body weight in the majority of the donors after two leukaphereses.
Qabel trapjant alloġenejiku ta ’ ċelluli proġenitriċi tad- demm periferali, l- użu ta’ filgrastim għall- mobilizzazzjoni ta ’ ċelluli proġenitriċi tad- demm periferali f’ donaturi normali jippermetti li jinġabru 4 x 106 CD34+ celluli għal kull kg ta ’ piż tal- ġisem tar- riċevitur, fil- maġġoranza ta ’ donaturi, wara żewġ proċeduri ta ’ lewkafereżi.
Normal donors are given a dose of a 10 μ g/ kg/ day, administered subcutaneously for 4 to 5 consecutive days.
Donaturi normali jingħataw doża ta ’ 10 μg/ kg/ jum, amministrata taħt il- ġilda għal 4 sa 5 ijiem konsekuttivi.
Use of filgrastim in patients, children or adults, with SCN (severe congenital, cyclic, and idiopathic neutropenia) induces a sustained increase in absolute neutrophil counts in peripheral blood and a reduction of infection and related events.
L- użu ta ’ filgrastim f’ pazjenti, tfal u adulti, b’ SCN (newtropenja qawwija, konġenitali, ċiklika, u idjopatika) iwassal għal żjieda sostenibbli fl- għadd assolut ta ’ newtrofili fid- demm periferali u tnaqqis fin- numru ta ’ infezzjonijiet u ġrajjiet relatati.
14 Use of filgrastim in patients with HIV infection maintains normal neutrophil counts to allow scheduled dosing of antiviral and/ or other myelosuppressive medicinal product.
L’ użu ta ’ filgrastim f’ pazjenti b’ infezzjoni ta ’ HIV iżomm l- għadd ta ’ newtrofili normali sabiex jippermetti id- dożaġġ skedat tat- terapija antivirali u/ jew mediċina majelosoppressiva oħra.
There is no evidence that patients with HIV infection treated with filgrastim show an increase in HIV replication.
M’ hemmx evidenza li pazjenti b’ infezzjoni ta ’ HIV ikkurati b’ filgrastim ikollhom żieda fir- replikazzjoni ta ’ HIV.
As with other haematopoietic growth factors, G-CSF has shown in vitro stimulating properties on human endothelial cells.
Bħal fil- każ ta ’ fatturi ta ’ tkabbir ematopojetiċi oħra, G- CSF wera proprjetajiet stimolanti in vitro fuq ċelluli endoteljali umani.
The efficacy and safety of Biograstim has been assessed in randomised, controlled phase III studies in breast cancer, lung cancer and Non-Hodgkin-Lymphoma.
L- effikaċja u s- sigurta ’ ta ’ Biograstim ġew stmati fi studji ta ’ fażi III, randomised u kontrollati bi placebo, f’ pazjenti b’ kanċer tas- sider, kanċer tal- pulmun u Non- Hodgkin- Limfoma.
There were no relevant differences between Biograstim and the reference product with regard to duration of severe neutropenia and incidence of febrile neutropenia.
Ma kienx hemm differenzi rilevanti bejn Biograstim u l- prodott ta ’ referenza fir- rigward ta ’ dewmien ta ’ newtropenja qawwija u l- inċidenza ta ’ newtropenja bid- deni.
Randomised, single-blind, single dose, crossover studies in 196 healthy volunteers showed that the pharmacokinetic profile of Biograstim was comparable to that of the reference product after subcutaneous and intravenous administration.
Studji randomised, single- blind, b’ doża waħda u crossover li saru fuq 196 voluntiera b’ saħħithom urew li l- profil farmakokinetiku ta’ Biograstim kien komparabbli ma ’ dak tal- prodott ta ’ referenza kemm wara amministrazzjoni taħt il- ġilda kif ukoll ġol- vina.
Clearance of filgrastim has been shown to follow first-order pharmacokinetics after both subcutaneous and intravenous administration.
Intwera li l- eliminazzjoni ta ’ filgrastim isegwi proċess farmakokinetiku ta ’ l- ewwel ordni kemm wara amministrazzjoni taħt il- ġilda kif ukoll ġol- vina.
The serum elimination half-life of filgrastim is approximately 3.5 hours, with a clearance rate of approximately 0.6 ml/ min/ kg.
Il- half- life ta ’ eliminazzjoni ta ’ filgrastim hija ta ’ madwar 3. 5 siegħa, b’ rata ta ’ tneħħija ta ’ madwar 0. 6 ml/ min/ kg.
Continuous infusion with filgrastim over a period of up to 28 days, in patients recovering from autologous bone-marrow transplantation, resulted in no evidence of drug accumulation and comparable elimination half-lives.
Waqt infużjoni kontinwa b’ filgrastim fuq medda ta ’ 28 ġurnata, f’ pazjenti li kienu qedin jirkupraw minn trapjant awtologu tal- mudullun, ma kienx hemm xi evidenza ta’ akkumulazzjoni u l- half- lives ta ’ eliminazzjoni kienu komparabbli.
There is a positive linear correlation between the dose and the serum concentration of filgrastim, whether administered intravenously or subcutaneously.
Hemm correlazzjoni posittiva u linejari bejn id- doża u l- konċentrazzjoni ta ’ filgrastim fis- serum, kemm meta jiġi amministrat ġol- vina kif ukoll taħt il- ġilda.
Following subcutaneous administration of recommended doses, serum concentrations were maintained above 10 ng/ ml for 8 to 16 hours.
Wara l- amministrazzjoni taħt il- ġilda tad- doża rakkomandata, il- konċentrazzjoni fis- serum nżammet il- fuq minn 10 ng/ ml għal 8 sa16- il siegħa.
The volume of distribution in blood is approximately 150 ml/ kg.
Il- volum ta 'distribuzzjoni fid- demm hu madwar 150 ml/ kg.
In cancer patients, the pharmacokinetic profile of Biograstim and the reference product was comparable after single and repeated subcutaneous administration.
F’ pazjenti b’ kanċer, il- profil farmacokinetiku ta ’ Biograstim u dak tal- prodott ta ’ referenza kienu komparabbli wara amministrazzjoni taħt il- ġilda ta ’ doża waħda jew dożi ripetuti.
5.3 Preclinical safety data
5. 3 Tagħrif ta 'qabel l- użu kliniku dwar is- sigurtà tal- mediċina
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, genotoxicity and local tolerance.
Informazzjoni li mhiex klinika, magħmula fuq studji konvenzjonali ta ’ sigurtà farmakoloġika, effett tossiku fuq il- ġeni u tolleranza lokali, ma turi l- ebda periklu speċjali għall- bnedmin.
Preclinical data from conventional studies of repeated dose toxicity revealed the expected pharmacological effects including increases in leukocyte count, myeloid hyperplasia in bone marrow, extramedullary haematopoiesis and splenic enlargement.
15 Tagħrif ta ’ qabel l- użu kliniku miġbur minn studji konvenzjonali fuq l- effett tossiku minn dożi riptetuti, ikkonferma l- effetti mistennija, fosthom żjidiet fl- għadd ta ’ lewkoċiti, iperplasija majelojde fil- mudullun, ematopojesi ekstramedullari u tkabbir tal- milza.
No effect was observed on the fertility of male and female rats or gestation in rats.
Ma kienx hemm l- ebda effett fuq il- fertilità fil- firien maskili u femminili jew fuq il- frieħ ta ’ firien tqal.
There is no evidence from studies in rats and rabbits that filgrastim is teratogenic.
Minn studji li saru fuq firien u fniek, m’ hemmx evidenza li turi li filgrastim għandu xi effett teratoġeniku.
An increased incidence of embryo-loss has been observed in rabbits, but no malformation has been seen.
Żjieda fl- inċidenza ta ’ telfien tal- embriju ġiet osservata fil- fniek, iżda ma dehrux malformazzjonijiet.
Acetic acid, glacial Sodium hydroxide Sorbitol (E420) Polysorbate 80 Water for injections
Acetic acid, glacial Sodium hydroxide Sorbitol (E420) Polysorbate 80 Ilma għall- injezzjoni
15 Biograstim should not be diluted with sodium chloride solution.
Biograstim m’ għandux jiġi dilwit ma ’ soluzzjoni ta ’ sodium chloride.
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Dan il- prodott mediċinali m’ għandux jitħallat ma ’ prodotti mediċinali oħrajn ħlief dawk imsemmija f’ sezzjoni 6. 6.
Diluted filgrastim may be adsorbed to glass and plastic materials except diluted, as mentioned in section 6.6.
Filgrastim dilwit jista ’ jiġi adsorbit fuq il- ħġieġ jew ħwejjeġ tal- plastik ħlief meta jiġi dilwit kif inhu msemmi f’ sezzjoni 6. 6.
2 years.
Sentejn.
After dilution:
Wara d- dilwit:
Chemical and physical in-use stability of the diluted solution for infusion has been demonstrated for 24 hours at 2 °C to 8 °C.
Is- soluzzjoni għall- infużjoni dilwita wriet stabbilita ’ kimika u fiżika waqt l- użu għal 24 siegħa f’ temperatura bejn 2°C u 8°C.
From a microbiological point of view, the product should be used immediately.
Mill- lat tas- sigurtà mikrobijoloġika, il- prodott għandu jintuża immedjatament.
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 °C to 8 °C, unless dilution has taken place in controlled and validated aseptic conditions.
Jekk ma jintużax immedjatament, il- konsumatur huwa risponsabbli għaż- zmien u l- kundizzjonijient ta ’ ħażna qabel ma ’ jintuża, u dawn s- soltu ma jridux ikunu iktar minn 24 siegħa f’ temperatura ta ’ bejn 2 °C – 8 °C, sakemm id- dilwit ma jkunx seħħ taħt kundizzjonijiet kontrollati, asettiċi u validati.
Store in a refrigerator (2 °C – 8 °C).
Aħżen fi friġġ (2°C – 8°C)
For storage conditions of the diluted medicinal product, see section 6.3.
Għall- kundizzjonijiet ta ’ ħażna tal- prodott mediċinali dilwit, ara sezzjoni 6. 3.
Type I glass pre-filled syringe with a permanently attached stainless steel needle.
Siringa mimlija għal- lest magħmula minn ħġieġ ta ’ Tip I b’ labbra ta ’ l- azzar li ma jissaddadx mwaħħla permanentement.
Packs containing 1, 5 or 10 pre-filled syringes with 0.5 ml solution for injection or infusion or multipacks containing 10 (2 packs of 5) pre-filled syringes with 0.5 ml solution for injection or infusion.
Pakketti ta ’ 1, 5 jew 10 siringi mimlijin għal- lest b ’ 0. 5 ml soluzzjoni għall- injezzjoni jew infużjoni jew pakkett multiplu li fih 10 (2 pakketti ta ’ 5) siringi mimlijin għal- lest b ’ 0. 5 ml soluzzjoni għall- injezzjoni jew infużjoni
Not all pack sizes may be marketed.
16 Jista jkun li mhux il- pakketti tad- daqsijiet kollha jkunu għall- skop kummerċjali.
If required, Biograstim may be diluted in glucose 50 mg/ ml (5%) solution for infusion.
Jekk ikun hemm il- ħtieġa, Biograstim jista ’ jiġi dilwit f’ soluzzjoni għal infużjoni ta ’ glucose 50 mg/ ml (5%).
Dilution to a final concentration less than 0.2 MIU (2 μ g) per ml is not recommended at any time.
Huwa rakkomandat li fl- ebda ħin id- dilwit ma jwassal għal konċentrazzjoni finali inqas minn 0. 2 MIU (2 μg) / ml.
The solution should be visually inspected prior to use.
Qabel ma tingħata, is- soluzzjoni trid tiġi spezzjonata viżwalment.
Only clear solutions without particles should be used.
Għandhom jsiru injezzjonijiet biss b’ soluzzjoni li tkun ċara u mingħajr frak.
For patients treated with filgrastim diluted to concentrations below 1.5 MIU (15 μ g) per ml, human serum albumin (HSA) should be added to a final concentration of 2 mg/ ml.
Fejn pazjenti jirċievu soluzzjoni ta ’ filgrastim dilwit sa konċentrzzjoni inqas minn 15 MIU (15 μg) / ml, għandha tiġi miżjuda bl- albumina umana (HSA) sabiex il- konċentrazzjoni finali tkun 2 mg/ ml.
Example:
Eżempju:
In a final injection volume of 20 ml, total doses of filgrastim less than 30 MIU (300 μ g) should be given with 0.2 ml of 200 mg/ ml (20%) human albumin solution added.
Meta l- volum finali ta ’ l- injezzjoni huwa 20 ml, id- dożi kollha ta ’ filgrastim li fihom inqas minn 30 MIU (300 μg) iridu jingħataw b’ 0. 2 ml soluzzjoni ta ’ 200mg/ ml (20%) albumina umana miżjuda.
When diluted in glucose 50 mg/ ml (5%) solution for infusion, Biograstim is compatible with glass and a variety of plastics including PVC, polyolefin (a co-polymer of polypropylene and polyethylene) and polypropylene.
Meta jiġi dilwit ġo soluzzjoni għal infużjoni ta’ glucose 50 mg/ ml (5%), Biograstim huwa kompatibbli mal- ħġieġ u varji tipi ta ’ plastik, fosthom il- PVC, polyolefin (co- polymer ta ’ polypropylene u polyethylene) u polypropylene.
Biograstim does not contain any preservative.
Biograstim ma fih l- ebda preservattiv.
In view of the possible risk of microbial contamination, Biograstim syringes are for single use only.
Minħabba r- riskju potenzjali ta ’ kontaminazzjoni b’ mikrobi, is- siringi ta ’ Biograstim iridu jintużaw darba biss.
16 Accidental exposure to freezing temperatures does not adversely affect the stability of Biograstim.
L- esposizzjoni bi żball għal temperatura ta ’ friża ma jeffettwax ħażin l- istabilita` ta ’ Biograstim.
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.
CT Arzneimittel GmbH Lengeder Straße 42a D-13407 Berlin Germany info@ct-arzneimittel. de
CT Arzneimittel GmbH Lengeder Straße 42a D- 13407 Berlin Il- Ġermanja info@ ct- arzneimittel. de
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/.
Informazzjoni dettaljata dwar dan il- prodott tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il- Mediċini (EMEA) http: // www. emea. europa. eu /.
Biograstim 48 MIU/ 0.8 ml solution for injection or infusion
Biograstim 48 MIU/ 0. 8ml soluzzjoni għall- injezzjoni jew infużjoni
Each pre-filled syringe contains 48 MIU (480 µg) of filgrastim in 0.8 ml solution for injection or infusion.
Kull siringa mimlija għal- lest fiha 48 MIU (480 µg) filgrastim f’ 0. 8 ml soluzzjoni għall- injezzjoni jew infużjoni.
18 collaboration with an oncology-haematology centre with acceptable experience in this field and where the monitoring of haematopoietic progenitor cells can be correctly performed.
18 ma 'ċentru ta ’ l- onkoloġija u ematoloġija b’ esperjenza xierqa f’ dan il- qasam u fejn il- monitoraġġ taċ- ċelluli proġenitriċi ematopojetiċi jista ’ jsir korrettament.
For infusions, filgrastim should be diluted in 20 ml of glucose 50 mg/ ml (5%) solution for infusion (see section 6.6 for instructions on dilution).
Għal l- infużjoni, id- doża ta ’ filgrastim 19 trid tkun miżjuda ma ’ 20ml soluzzjoni ta ’ glucose 50 mg/ ml (5%) (ara sezzjoni 6. 6 għall- istruzzjonijiet fuq id- dilwit).
Further dose adjustment may be necessary, as determined by the patient's ANC, to maintain the neutrophil count at > 2.0 x 109/ l.
20 jkun hemm bżonn ta ’ aktar aġġustament fid- dożaġġ, li trid tiġi iddeterminata mill- ANC tal- pazjent, bl- għan li l- għadd ta ’ newtrofili jinżamm > 2. 0 x 109/ l.
In view of limited safety and efficacy data in patients with secondary AML, filgrastim should be administered with caution.
21 Minħabba tagħrif limitat dwar is- sigurta 'u l- effikaċja assoċjat mal- użu f’ pazjenti b’ Lewkimja Majelojde Akuta (AML) sekondarja, filgrastim għandu jingħata b’ kawtela f’ dawn il- każi.
21 Other special precautions Monitoring of bone density may be indicated in patients with underlying osteoporotic bone diseases who undergo continuous therapy with filgrastim for more than 6 months.
Prekawzjonijiet speċjali oħrajn Jista ’ jkun hemm bżonn ta ’ monitoraġġ tad- densita ta ’ l- għadam f’ pazjenti li jkollhom xi mard ta ’ ostejoporosi u li jinħtieġu kura kontinwa b’ filgrastim għal iktar minn 6 xhur.
Increased haematopoietic activity of the bone marrow in response to growth factor therapy has been associated with transient positive bone-imaging findings.
22 Żjieda fl- attività ematopojetika fil- mudullun f' rispons għal terapija ta 'fattur tat- tkabbir ġiet assoċjata ma' sejbiet transitorja posittivi fl- istampi tal- għadam.
Transient thrombocytopenia (platelets < 100 x 109/ l) following filgrastim administration and leukapheresis was observed in 35% of subjects studied.
23 Wara l- amministrazzjoni ta ’ filgrastim u proċedura ta ’ lewkafereżi, ġiet osservata tromboċitopenja transitorja (plejtlits < 100 x 109/ l) f’ 35% tas- suġġeti li ġew studjati.
23 Filgrastim administration should be discontinued or its dosage should be reduced if the leukocyte counts rise to > 70 x109/ l.
Il- kura b’ filgrastim trid titwaqqaf jew id- dożaġġ jitnaqqas jekk l- għadd ta ’ lewkoċiti jaqbeż is- 70 x109/ l.
24 radiographically, occurred early during filgrastim therapy and tended to plateau.
Żjidiet fil- volum, imkejla permezz ta ’ evalwazzjoni radjografika, seħħu kmieni fil- bidu ta ’ kura b’ filgrastim u mbagħad laħqu plateau.
Special precautions in sickle cell disease
25 Prekawzjonijiet speċjali f’ pazjenti bil- marda taċ- ċelluli Sickle
25 Possible interactions with other haematopoietic growth factors and cytokines have not yet been investigated in clinical trials.
L- interazzjonijiet possibbli ma ’ fatturi ta ’ tkabbir ematopojetiċi u ċitokini għadhom ma ġewx investigati speċifikament fi studji kliniċi.
Very common:
26 Komuni ħafna:
26 Reversible, dose-dependent and usually mild or moderate elevations of lactate dehydrogenase (LDH), alkaline phosphatase, serum uric acid and gamma-glutamyltransferase (GGT) occurred with filgrastim in approximately 50%, 35%, 25%, and 10% of patients respectively, at recommended doses.
Żjidiet ħfief għal moderati, li reġgħu lura għan- normal, u li kienu dipendenti fuq id- doża, f’ lactate dehydrogenase (LDH), alkaline phosphatase, serum uric acid u gamma- glutamyltransferase (GGT), seħħu f’ madwar 50%, 35%, 25%, u 10% tal- pazjenti rispettivament, bl- użu ta ’ filgrastim bid- dożi rakkomandati.
Isolated cases of sickle cells crises have been reported in patients with sickle cell disease (see section 4.4).
27 Każijiet iżolati ta ’ kriżi tal- marda taċ- ċelluli Sickle ġew rapportati f’ pazjenti bil- marda taċ- ċelluli Sickle (ara sezzjoni 4. 4).
27
Għeja, debbulizza Uġigħ ġenerali Reazzjoni allerġiku
28 In SCN patients
28
Use of filgrastim, either alone or after chemotherapy, mobilises haematopoietic progenitor cells into peripheral blood.
30 L- użu ta ’ filgrastim, waħdu jew wara kimoterapija, jimmobilizza ċ- celluli proġenitriċi ematopojetiċi għal ġod- demm periferiku.
30 Use of filgrastim in patients with HIV infection maintains normal neutrophil counts to allow scheduled dosing of antiviral and/ or other myelosuppressive medicinal product.
L’ użu ta ’ filgrastim f’ pazjenti b’ infezzjoni ta ’ HIV iżomm l- għadd ta ’ newtrofili normali sabiex jippermetti id- dożaġġ skedat tat- terapija antivirali u/ jew mediċina majelosoppressiva oħra.
Preclinical data from conventional studies of repeated dose toxicity revealed the expected pharmacological effects including increases in leukocyte count, myeloid hyperplasia in bone marrow, extramedullary haematopoiesis and splenic enlargement.
31 Tagħrif ta ’ qabel l- użu kliniku miġbur minn studji konvenzjonali fuq l- effett tossiku minn dożi riptetuti, ikkonferma l- effetti mistennija, fosthom żjidiet fl- għadd ta ’ lewkoċiti, iperplasija majelojde fil- mudullun, ematopojesi ekstramedullari u tkabbir tal- milza.
31 Biograstim should not be diluted with sodium chloride solution.
Biograstim m’ għandux jiġi dilwit ma ’ soluzzjoni ta ’ sodium chloride.
Packs containing 1, 5 or 10 pre-filled syringes with 0.8 ml solution for injection or infusion or multipacks containing 10 (2 packs of 5) pre-filled syringes with 0.8 ml solution for injection or infusion.
Pakketti ta ’ 1, 5 jew 10 siringi mimlijin għal- lest b ’ 0. 8 ml soluzzjoni għall- injezzjoni jew infużjoni jew pakkett multiplu li fih 10 (2 pakketti ta ’ 5) siringi mimlijin għal- lest b ’ 0. 8 ml soluzzjoni għall- injezzjoni jew infużjoni
Not all pack sizes may be marketed.
32 Jista jkun li mhux il- pakketti tad- daqsijiet kollha jkunu għall- skop kummerċjali.
32 Accidental exposure to freezing temperatures does not adversely affect the stability of Biograstim.
L- esposizzjoni bi żball għal temperatura ta ’ friża ma jeffettwax ħażin l- istabilita` ta ’ Biograstim.
33 ANNEX II
33 ANNESS II
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
MANIFATTUR TAS- SUSTANZA BIJOLOĠIKA ATTIVA U DETENTUR TA ’ L- AWTORIZZAZZJONI TAL - MANIFATTURA RESPONSABBLI GĦALL- HRUĠ TAL - LOTT
CONDITIONS OF THE MARKETING AUTHORISATION
KUNDIZZJONIJIET TA 'L- AWTORIZZAZZJONI GĦAT - TQEGĦID FIS- SUQ
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
MANIFATTUR TAS- SUSTANZA BIJOLOĠIKA ATTIVA U DETENTUR TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- HRUĠ TAL- LOTT
5 LT-08409 Vilnius Lithuania
5 LT- 08409 Vilnius Il- Litwanja
Name and address of the manufacturer responsible for batch release
Isem u indirizz tal- manifattur responsabbli għall- ħruġ tal- lott.
Merckle Biotec GmbH Dornierstraße 10 DE-89079 Ulm Germany
Merckle Biotec GmbH Dornierstraße 10 DE- 89079 Ulm Il- Ġermanja
CONDITIONS OF THE MARKETING AUTHORISATION
KUNDIZZJONIJIET TA 'L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
Medicinal product subject to restricted medical prescription (See Annex I:
Prodott mediċinali jingħata b' riċetta ristretta tat- tabib (Ara Anness I:
Summary of Product Characteristics, section 4.2).
Sommarju tal - Karatteristiċi tal- Prodott, sezzjoni 4. 2)
Not applicable
Ma jgħoddx f’ dan il- każ.
Pharmacovigilance system The MAH must ensure that the system of pharmacovigilance, as described in version 2.2 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Pjan tal- Farmakoviġilanza L- MAH irid jiżgura li s- sistema ta ’ farmakoviġilanza, kif deskritt f’ verżjoni 2. 1 ippreżentata f' Modulu 1. 8. 1. ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq, tkun implimentata u taħdem qabel ma l- prodott jibda jinbiegħ.
Risk Management Plan The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 5 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Pjan dwar l- Immaniġġjar tar- Riskju L- MAH huwa obbligat li jwettaq l- istudji u attivitajiet ta ’ farmakoviġilanza addizzjonali deskritti fil- pjan tal- Farmakoviġilanza, kif maqbul fil- verżjoni 5 tal- Pjan dwar l- Immaniġġjar tar- Riskju (RMP) ippreżentat f' Modulu 1. 8. 2. ta 'l- Awtorizzazzjoni għat- Tqegħid fis- Suq, u kwalunkwe aġġornamenti sussegwenti tal- RMP li kienu maqbula mis- CHMP.
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
Skond il- Linja Gwida CHPM dwar is- Sistemi ta ’ l- Immaniġġjar tar- Riskji għal prodotti mediċinali għall- użu uman, l- RMP aġġornat għandu jkun sottomess fl- istess ħin mar- Rapport Perjodiku dwar l- Aġġornament tas- Sigurtà (PSUR) li jkun imiss.
In addition, an updated RMP should be submitted • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached • At the request of the EMEA
Flimkien ma 'dan, RMP aġġornat għandu jkun sottomess: • Meta informazzjoni ġdida tkun irċevuta li jista' jkollha impatt fuq l- Ispeċifazzjoni tas - Sigurtà kurrenti, fuq il- Pjan tal- Farmakoviġilanza jew fuq attivitajiet li jimminimizzaw ir- riskju. • Fi żmien 60 jum minn meta tintlaħaq milestone importanti (Farmakoviġilanza jew minimizzazzjoni tar- riskju) • Fuq talba tal- EMEA
35 ANNEX III
35 ANNESS III
37 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
37 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Outer Carton
PAKKETT TA ’ BARRA
Each pre-filled syringe contains 30 million international units [MIU] (300 microgram) of filgrastim in 0.5 ml (60 MIU/ ml, 600 microgram/ ml).
Kull siringa mimlija għal- lest fiha 30 miljun international units [MIU] (300 mikrogrammi) filgrastim f’ 0. 5 ml (60 MIU/ ml, 600 mikrogrammi/ ml).
Sodium hydroxide, glacial acetic acid, sorbitol, polysorbate 80, water for injections.
Sodium hydroxide, glacial acetic acid, sorbitol, polysorbate 80, ilma għall - injezzjoni.
Read the package leaflet before use.
Aqra il- fuljett ta ’ tagħrif qabel l- użu
1 pre-filled syringe with 0.5 ml
1 siringa mimlija għal- lest b’ 0. 5 ml
5 pre-filled syringes with 0.5 ml
5 siringa mimlija għal- lest b’ 0. 5 ml
10 pre-filled syringes with 0.5 ml
10 siringa mimlija għal- lest b’ 0. 5 ml
Read the package leaflet before use.
Aqra sew il- fuljett kollu qabel ma tibda tuża din il- mediċina.
Subcutaneous use and intravenous use.
Użu għal taħt il- ġilda u għal ġol- vini.
For single use only.
Jintuża darba biss.
Please use as follows:
Jekk jogħġbok, uża kif ġej:
Box for the prescribed dose
Kaxxa għad- doża preskritta
EXP
JIS:
After dilution use within 24 hours.
Wara li jiġi dilwit użah fiż- żmien 24 siegħa.
SPECIAL STORAGE CONDITIONS
KUNDIZZJONIJIET SPEĊJALI TA 'KIF JINĦAŻEN
Store in a refrigerator.
Aħżen fi friġġ
Batch
LOTT:
INSTRUCTIONS ON USE
STRUZZJONIJIET DWAR L- UŻU
Biograstim 30 MIU/ 0.5 ml
Biograstim 30 MIU/ 0. 5ml
39 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
39 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Each pre-filled syringe contains 48 million international units [MIU] (480 microgram) of filgrastim in 0.8 ml (60 MIU/ ml, 600 microgram/ ml).
Kull siringa mimlija għal- lest fiha 48 miljun international units [MIU] (480 mikrogrammi) filgrastim f’ 0. 8 ml (60 MIU/ ml, 600 mikrogrammi/ ml).
Read the package leaflet before use.
Aqra il- fuljett ta ’ tagħrif qabel l- użu.
1 pre-filled syringe with 0.8 ml
1 siringa mimlija għal- lest b’ 0. 8 ml
5 pre-filled syringes with 0.8 ml
5 siringa mimlija għal- lest b’ 0. 8 ml
10 pre-filled syringes with 0.8 ml
10 siringa mimlija għal- lest b’ 0. 8 ml
After dilution use within 24 hours.
Wara li jiġi dilwit użah fiż żmien 24 siegħa.
Batch
LOTT
Biograstim 48 MIU/ 0.8 ml
Biograstim 48 MIU/ 0. 8ml
41 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
41 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA