qanastek/EMEA-V3 huggingface dataset:
Once the rubber inlay of a cartridge is pierced by a needle, the product may be stored for a maximum of 28 days.
La darba l- inforra tal- lastku ta 'stoċċ ikun ittaqqab minn labra, il- prodott jista' jinħażen għal massimu ta '28 jum.
Please put the day of first use of the cartridge on the dosing record table as shown in the Instruction Manual of the Puregon Pen.
Jekk jogħġbok niżżel id- data tal- istoċċ fit- tabella skedata ta 'dożaġġ kif muri fil Manwal tal - Istruzzjonijiet tal- Puregon Pen.
Do not use Fertavid if you notice that the solution contains particles or is not clear.
Tużax Fertavid jekk tinnota li fis- soluzzjoni hemm xi frak jew li mhix ċara.
Discard used needles immediately after injection.
Armi l- labar minnufih wara l- injezzjoni.
Fertavid cartridges are not designed to allow any other drug to be mixed in the cartridges.
L- istoċċijiet ta 'Fertavid m' humiex magħmula sabiex jippermettu xi mediċina oħra biex tiġi mħalta mal- istoċċi.
Empty cartridges must not be refilled.
Stoċċijiet vojta m' għandhomx jimtlew mill- ġdid.
What Fertavid contains
151 X’ fih Fertavid
146 • The active substance is follitropin beta, a hormone known as follicle-stimulating hormone (FSH) in a strength of 833 IU/ ml aqueous solution per cartridge. • The other ingredients are sucrose, sodium citrate, L-methionine, polysorbate 20 and benzyl alcohol in water for injections.
• Is- sustanza attiva hija follitropin beta, ormon magħruf bħala l- ormon li jistimula l- follikoli (FSH) f 'qawwa ta' 833 IU/ ml soluzzjoni akwea f’ kull stoċċ. • Is- sustanzi l- oħra huma sucrose, sodium citrate, L- methionine, polysorbate 20 u benzyl alcohol f' ilma għall- injezzjonijiet.
The pH may have been adjusted with sodium hydroxide and/ or hydrochloric acid.
Il- pH jista jiġi aġġustat b’ sodium hydroxide u/ jew hydrochloric acid.
It is supplied in a glass cartridge.
Hi tiġi fi stoċċ tal- ħgieġ.
It is available in packs of 1 cartridge.
Hi disponibbli f' pakketti ta 'stoċċ wieħed.
Dublin, Ireland
Dublin, l- Irlanda
147 PACKAGE LEAFLET:
152 FULJETT TA ’ TAGĦRIF:
Read all of this leaflet carefully before you start using this medicine. − Keep this leaflet.
Aqra sew dan- il fuljett kollu qabel tibda tuża din il- mediċina
You may need to read it again. − If you have any further questions, ask your doctor or pharmacist. − This medicine has been prescribed for you.
- Jekk ikollok aktar mistoqsijiet, jekk jogħġbok staqsi lit- tabib jew lill- ispiżjar tiegħek.
It may harm them, even if their symptoms are the same as yours. − If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
- Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li m’ humiex
Fertavid 300 IU/ 0.36 ml solution for injection contains a hormone known as follicle-stimulating hormone (FSH) in a strength of 833 IU/ ml.
Fertavid 300 IU/ 0. 36 ml soluzzjoni għall- injezzjoni fih l- ormon magħruf bħala l- ormon li jistimula l - follikuli (FSH) f' qawwa ta '833 IU/ ml.
• if you have a tumour of the ovary, breast, uterus, testis, pituitary gland or hypothalamus • if you are allergic (hypersensitive) to follitropin beta or any of the other ingredients of Fertavid • if you have heavy or irregular vaginal bleeding where the cause is not known • if you suffer from primary ovarian failure • if you have ovarian cysts or enlarged ovaries not caused by polycystic ovarian disease (PCOD) • if you have malformations of the sexual organs which make a normal pregnancy impossible • if you have fibroids in the uterus which make a normal pregnancy impossible • if you suffer from primary testicular failure.
• jekk għandek tumur tal- ovarju, tas- sider, tal- utru, tat- testikoli, tal- glandola pitwitarja jew tal - ipotalamu. • jekk inti allerġika/ u (tbati minn sensittività eċċessiva) għal follitropin beta jew għal xi wieħed mis- sustanzi l- oħra ta ’ Fertavid • jekk għandek emorraġija vaġinali qawwija jew irregolari fejn il- kawża mhix magħrufa • jekk tbati minn indeboliment primarju tal- ovarju • jekk għandek ċisti fl- ovarji jew ovarji mkabbra li m’ humiex ikkawżati minn mard poliċistiku tal- ovarji (PCOD) • jekk għandek malformazzjonijiet tal- organi sesswali li jagħmel tqala normali impossibbli • jekk għandek il- fibrojdi fl- utru li jagħmel tqala normali impossibli • jekk tbati minn indeboliment primarju tat- testikoli.
Take special care with Fertavid
153 Oqgħod attent ħafna b’ Fertavid
148 Please inform your doctor if you have experienced an allergic reaction to neomycin and/ or streptomycin (antibiotics) in the past.
Jekk jogħġbok informa lit- tabib tiegħek jekk qatt kellek xi allerġija għal neomycin u/ jew streptomycin (antibijotiċi) fil- passat.
Furthermore, multiple pregnancies and characteristics of the patients undergoing fertility treatment (e. g. age of the female, sperm characteristics) may be associated with an increased risk of congenital abnormalities.
Barra minnhekk, tqala multipla u l- karatteristiċi tal- pazjenti li jkunu qed jingħataw kura għal fertilità (eż età tal- mara, karatteristiċi tal- isperma) jistgħu jkunu assoċjati ma ’ riskju ogħla ta ’ anormalitajiet konġenitali.
149 Always use Fertavid exactly as your doctor has told you.
Dejjem għandek tuża Fertavid skont il- parir eżatt tat- tabib.
Fertavid solution for injection in cartridges has been developed for use in a pen injector called Puregon Pen.
Fertavid, soluzzjoni għall- injezzjoni fl- istoċċi ġie żviluppat biex jintuża ma ’ pinna li tinjetta msejħa Puregon Pen.
The separate instructions for using the pen must be followed carefully.
L- istruzzjonijiet separati għall- użu tal- pinna għandhom jiġu segwiti b' attenzjoni.
Like all medicines, Fertavid can cause side effects, although not everybody gets them.
155 Bħal mediċini kollha Fertavid jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
150 Minor side effects include bruising, pain, redness, swelling and itching at the site of the injection.
Effetti żgħar oħra jinkludu tbenġil, uġigħ, ħmura, nefħa u ħakk fil- lok tal- injezzjoni.
Store in a refrigerator (2 °C – 8 °C).
Aħżen fi friġġ (2 °C – 8°C).
Do not use Fertavid if you notice that the solution contains particles or is not clear.
Tużax Fertavid jekk tinnota li fis- soluzzjoni hemm xi frak jew li mhiex ċara.
151 • The active substance is follitropin beta, a hormone known as follicle-stimulating hormone (FSH) in a strength of 833 IU/ ml aqueous solution per cartridge. • The other ingredients are sucrose, sodium citrate, L-methionine, polysorbate 20 and benzyl alcohol in water for injections.
156 • Is- sustanza attiva hija follitropin beta, ormon magħruf bħala l- ormon li jistimula l- follikulu (FSH) f 'qawwa ta' 833 IU/ ml soluzzjoni akwea f’ kull stoċċ. • Is- sustanzi l- oħra huma sucrose, sodium citrate, L- methionine, polysorbate 20 u benzyl alcohol f' ilma għall- injezzjonijiet.
152 PACKAGE LEAFLET:
157 FULJETT TA ’ TAGĦRIF:
Fertavid 600 IU/ 0.72 ml solution for injection contains a hormone known as follicle-stimulating hormone (FSH) in a strength of 833 IU/ ml.
Fertavid 600 IU/ 0. 72 ml soluzzjoni għall- injezzjoni fih l- ormon magħruf bħala l- ormon li jistimula l - follikuli (FSH) f' qawwa ta '833 IU/ ml.
• if you have a tumour of the ovary, breast, uterus, testis, pituitary gland or hypothalamus • if you areallergic (hypersensitive) to follitropin beta or any of the other ingredients of Fertavid • if you have heavy or irregular vaginal bleeding where the cause is not known • if you suffer from primary ovarian failure • if you have ovarian cysts or enlarged ovaries not caused by polycystic ovarian disease (PCOD) • if you have malformations of the sexual organs which make a normal pregnancy impossible • if you have fibroids in the uterus which make a normal pregnancy impossible • if you suffer from primary testicular failure.
• jekk għandek tumur tal- ovarju, tas- sider, tal- utru, tat- testikoli, tal- glandola pitwitarja jew tal - ipotalamu. • jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal follitropin beta jew għal xi wieħed mis- sustanzi l- oħra ta ’ Fertavid • jekk għandek emorraġija vaġinali qawwija jew irregolari fejn il- kawża mhix magħrufa • jekk tbati minn indeboliment primarju tal- ovarju • jekk għandek ċisti fl- ovarji jew ovarji mkabbra li m’ humiex ikkawżati minn mard poliċistiku tal- ovarji (PCOD) • jekk għandek malformazzjonijiet tal- organi sesswali li jagħmel tqala normali impossibbli • jekk għandek il- fibrojdi fl- utru li jagħmel tqala normali impossibli
153 Please inform your doctor if you have experienced an allergic reaction to neomycin and/ or streptomycin (antibiotics) in the past.
Jekk jogħġbok informa lit- tabib tiegħek jekk qatt kellek xi allerġija għal neomycin u/ jew streptomycin (antibijotiċi) fil- passat.
154 Always use Fertavid exactly as your doctor has told you.
Dejjem għandek tuża Fertavid skont il- parir eżatt tat- tabib.
See section on Possible side effects below.
Ara s- sezzjoni fuq Effetti Sekondarji li Jista ’ Jħollu li tidher hawn isfel.
If you forget to use Fertavid
Jekk tinsa tieħu Fertavid
155 Minor side effects include bruising, pain, redness, swelling and itching at the site of the injection.
Effetti żgħar oħra jinkludu tbenġil, uġigħ, ħmura, nefħa u ħakk fil- lok tal- injezzjoni.
If any of the side effects gets serious, or if you notice any side efefcts not listed in this leaflet, please tell your doctor or pharmacist.
Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett, jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek.
Do not use Fertavid after the expiry date which is stated on the label after'EXP: '.
Tużax Fertavid wara d- data ta ’ skadenza li tidher fuq it- tikketta wara ‘ JIS: ’ Aħżen fi friġġ (2 °C – 8°C).
Do not use Fertavid if you notice that the solution contains particles or is not clear.
Tużax Fertavid jekk tara li fis- soluzzjoni hemm xi frak jew li mhix ċara.
Fertavid cartridges are not designed to allow any other drug to be mixed in the cartridges.
L- istoċċijiet ta 'Fertavid m' humiex magħmula sabiex jippermettu xi mediċina oħra biex tiġi mħallta mal- istoċċijiet.
What Fertavid contains
161 X’ fih Fertavid
156 • The active substance is follitropin beta, a hormone known as follicle-stimulating hormone (FSH) in a strength of 833 IU/ ml aqueous solution per cartridge. • The other ingredients are sucrose, sodium citrate, L-methionine, polysorbate 20, benzyl alcohol in water for injections.
• Is- sustanza attiva hija follitropin beta, ormon magħruf bħala l- ormon li jistimula l- follikoli (FSH) f 'qawwa ta' 833 IU/ ml soluzzjoni akwea f’ kull stoċċ. • Is- sustanzi l- oħra huma sucrose, sodium citrate, L- methionine, polysorbate 20 u benzyl alcohol f' ilma għall- injezzjonijiet.
The pH may have been adjusted with sodium hydroxide and/ or hydrochloric acid.
Il- pH jista ’ jiġi aġġustat b’ sodium hydroxide u/ jew hydrochloric acid.
157 PACKAGE LEAFLET:
162 FULJETT TA ’ TAGĦRIF:
Donot pass it on to others.
M’ għandekx tgħaddiha lil persuni oħra.
Fertavid 900 IU/ 1.08 ml solution for injection contains a hormone known as follicle-stimulating hormone (FSH) in a strength of 833 IU/ ml.
Fertavid 900 IU/ 1. 08 ml soluzzjoni għall- injezzjoni fih l- ormon magħruf bħala l- ormon li jistimula l - follikuli (FSH) f' qawwa ta '833 IU/ ml.
Fertavid is used to treat infertility in any of the following situations: • In women who are not ovulating, Fertavid can be used to cause ovulation in women who have not responded to treatment with clomifene citrate. • In women undergoing assisted reproduction techniques, including in vitro fertilisation (IVF) and other methods, Fertavid can be used to bring about the development of multiple follicles. • In men who are infertile due to a hormonal deficiency, Fertavid can be used for the production of sperm.
Fertavid jintuża biex jitratta l- infertilità f’ xi waħda mill- kondizzjonijiet li ġejjin: • Fin- nisa li m’ hux qed ikollhom ovulazzjoni, Fertavid jista ’ jintuża sabiex ikun hemm ovulazzjoni f’ nisa li ma ’ rrispondewx għall- kura bi clomifene citrate. • F’ nisa li qed jieħdu sehem fi programm li jinvolvi t- teknika ta ’ riproduzzjoni assistita, inkluż il - fertilizzazzjoni in vitro (IVF) u metodi oħra, Fertavid jista ’ jintuża sabiex jikkawża l- iżvilupp ta ’ follikuli multipli. • Fl- irġiel li huma infertili minħabba d- defiċenża ta ’ ormoni, Fertavid jista ’ jintuża għall - produzzjoni tal- isperma.
• if you have a tumour of the ovary, breast, uterus, testis, pituitary gland or hypothalamus • if you are allergic (hypersensitive) to follitropin beta or any of the other ingredients of Fertavid • if you have heavy or irregular vaginal bleeding where the cause is not known • if you suffer from primary ovarian failure • if you have ovarian cysts or enlarged ovaries not caused by polycystic ovarian disease (PCOD) • if you have malformations of the sexual organs which make a normal pregnancy impossible • if you have fibroids in the uterus which make a normal pregnancy impossible • if you suffer from primary testicular failure.
Tużax Fertavid • jekk għandek tumur tal- ovarju, tas- sider, tal- utru, tat- testikoli, tal- glandola pitwitarja jew tal - ipotalamu. • jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal follitropin beta jew għal xi wieħed mis- sustanzi l- oħra ta ’ Fertavid • jekk għandek emorraġija vaġinali qawwija jew irregolari fejn il- kawża mhix magħrufa • jekk tbati minn indeboliment primarju tal- ovarju • jekk għandek ċisti fl- ovarji jew ovarji mkabbra li m’ humiex ikkawżati minn mard poliċistiku tal- ovarji (PCOD) • jekk għandek malformazzjonijiet tal- organi sesswali li jagħmel tqala normali impossibbli • jekk għandek il- fibrojdi fl- utru li jagħmel tqala normali impossibli • jekk tbati minn indeboliment primarju tat- testikoli.
Take special care with Fertavid:
163 Oqgħod attent ħafna b’ Fertavid
158 Please inform your doctor if you have experienced an allergic reaction to neomycin and/ or streptomycin (antibiotics) in the past.
Jekk jogħġbok informa lit- tabib tiegħek jekk qatt kellek xi allerġija għal neomycin u/ jew streptomycin (antibijotiċi) fil- passat.
159 Always use Fertavid exactly as your doctor has told you.
Dejjem għandek tuża Fertavid skont il- parir eżatt tat- tabib.
Method and route of administration
Mod ta ’ kif u mnejn jingħata Fertavid, soluzzjoni għall- injezzjoni fl- istoċċi ġie żviluppat biex jintuża ma ’ pinna li tinjetta msejħa Puregon Pen.
Fertavid solution for injection in cartridges has been developed for use in a pen injector called Puregon Pen.
L- istruzzjonijiet separati għall- użu tal- pinna għandhom jiġu segwiti b' attenzjoni.
See section on Possible side effects below.
Ara s- sezzjoni fuq Effetti Sekondarji li Jista Jkollu li tidher hawn isfel.
160 Minor side effects include bruising, pain, redness, swelling and itching at the site of the injection.
165 Effetti żgħar oħra jinkludu tbenġil, uġigħ, ħmura, nefħa u ħakk fil- lok tal- injezzjoni.
Some breast development or acne may occur due to treatment with hCG.
Jista ’ jkun hemm xi żvilupp tas- sider jew akne minħabba l- kura bl- hCG.
Please put the day of first use of the cartridge on the dosing record table as shown in the Instruction Manual of the Puregon Pen.
Jekk jogħġbok niżżel id- data tal- istoċċ fit- tabella skedata ta 'dożaġġ kif muri fil Manwal tal- Istruzzjoni tal- Puregon Pen.
Do not use Fertavid if you notice that the solution contains particles or is not clear.
Tużax Fertavid jekk tinduna li fis- soluzzjoni hemm xi frak jew li mhix ċara.
161 • The active substance is follitropin beta, a hormone known as follicle-stimulating hormone (FSH) in a strength of 833 IU/ ml aqueous solution per cartridge. • The other ingredients are sucrose, sodium citrate, L-methionine, polysorbate 20 and benzyl alcohol in water for injections.
X’ fih Fertavid: • Is- sustanza attiva hija follitropin beta, ormon magħruf bħala l- ormon li jistimula l- follikuli 166 (FSH) f 'qawwa ta' 833 IU/ ml soluzzjoni akweja f’ kull stoċċ. • Is- sustanzi l- oħra huma sucrose, sodium citrate, L- methionine, polysorbate 20 u benzyl alcohol f' ilma għall- injezzjonijiet.
What is Filgrastim Hexal?
X’ inhu Filgrastim Hexal?
Filgrastim Hexal is a solution for injection or infusion (drip into a vein) in a pre-filled syringe.
Filgrastim Hexal huwa soluzzjoni għal injezzjoni jew infużjoni (dripp fil- vina) f’ siringa mimlija minn qabel.
It contains the active substance filgrastim (30 or 48 million units).
Fih is- sustanza attiva filgrastim (30 jew 48 miljun unità).
Filgrastim Hexal is a ‘ biosimilar’ medicine.
Filgrastim Hexal huwa mediċina ‘ bijosimili ’.
This means that Filgrastim Hexal is similar to a biological medicine that is already authorised in the European Union (EU) and contains the same active substance (also known as the ‘ reference medicine’).
Dan ifisser li Filgrastim Hexal huwa simili għal mediċina bijoloġika li hija diġà awtorizzata fl- Unjoni Ewropea (UE) u li tinkludi fiha l- istess sustanza attiva (magħrufa bħala ‘ mediċina ta ’ referenza ’).
The reference medicine for Filgrastim Hexal is Neupogen.
Il- mediċina ta ’ referenza għal Filgrastim Hexal hija Neupogen.
What is Filgrastim Hexal used for?
Għal xiex jintuża Filgrastim Hexal?
Filgrastim Hexal is used to stimulate the production of white blood cells in the following situations:  to reduce the duration of neutropenia (low levels of neutrophils, a type of white blood cell) and the occurrence of febrile neutropenia (neutropenia with fever) in patients receiving chemotherapy (cancer treatment) that is cytotoxic (cell-killing);  to reduce the duration of neutropenia in patients undergoing treatment to destroy the bone marrow cells before a bone marrow transplant (such as in some patients with leukaemia) if they are at a risk of long-term, severe neutropenia;  to increase levels of neutrophils and reduce the risk of infections in patients with neutropenia who have a history of severe, repeated infections;  to treat persistent neutropenia in patients with advanced human immunodeficiency virus (HIV) infection, to reduce the risk of bacterial infections when other treatments are not appropriate.
Filgrastim Hexal huwa użat sabiex jistimula l- produzzjoni ta ’ ċelloli bojod fid- demm fis - sitwazzjonijiet li ġejjin:  Inaqqas iż- żmien ta ’ newtropenija (livelli baxxi ta ’ newtrofili, tip ta ’ ċellola bajda tad- demm) u l - każ li jkun hemm newtropenija febbrili (newtropenija fil- fwied) f’ pazjenti li jirċievu l - kemoterapija (trattament tal- kanċer) li huwa ċitotossiku (joqtol iċ- ċelloli);  Inaqqas iż- żmien ta ’ newtropenija f’ pazjenti li għaddejjin bi trattament li jkisser iċ- ċelloli tal - mudullum qabel mal- mudullum jiġi trapjantat (bħal f’ xi pazjenti bil- lewkimja) jekk ikunu f’ riskju ta ’ newtropenija severa fuq żmien twil;  Iżid il- livelli ta ’ newtrofili u jnaqqas ir- riskju ta ’ infezzjonijiet f’ pazjenti bin- newtropenija li għandhom storja ta ’ infezzjonijiet severi u repetuti;  Jittratta newtropenija persistenti f’ pazjenti bil- vajrus uman tal- immunodefiċjenza fi stat avvanzat [HIV]).
Filgrastim Hexal can also be used in people who are about to donate blood stem cells for transplant, to help release these cells from the bone marrow.
Filgrastim Hexal jista ’ jintuża wkoll f’ pazjenti li ser jagħtu ċ- ċelloli staminali tad- demm għal trapjant, sabiex dan jgħin fir- rilaxx taċ- ċelloli mill- mudullum.
How is Filgrastim Hexal used?
Kif jintuża Filgrastim Hexal?
Filgrastim Hexal is given by injection under the skin or infusion into a vein.
Filgrastim Hexal jingħata b’ injezzjoni taħt il- ġilda jew infużjoni fil- vina.
How it is given, the dose and the duration of treatment depend on why it is being used, the patient’ s body weight and the response to treatment.
Il- mod ta ’ kif jingħata, id - doża u ż- żmien tat- trattament jiddependu fuq ir- raġuni tal- użu, il- massa korporja tal- pazjent u r - rispons għat- trattament.
Filgrastim Hexal is usually given in a specialised treatment centre, although patients who receive it by injection under the skin may inject themselves once they have been trained appropriately.
Filgrastim Hexal normalment jingħata f’ ċentru ta ’ trattament speċjalizzat, minkejja li pazjenti li jirċievuh b’ injezzjoni taħt il- ġilda jistgħu jinjettaw rwieħhom ladarba jiġu mħarrġa sabiex jagħmlu dan.
How does Filgrastim Hexal work?
Kif jaħdem Filgrastim Hexal?
The active substance in Filgrastim Hexal, filgrastim, is very similar to a human protein called granulocyte colony stimulating factor (G-CSF).
Is- sustanza attiva f’ Filgrastim Hexal, filgrastim hija simili ħafna għal proteina umana msejjħa stimulazzjoni tal- kolownja granuloċijto (G- CSF).
The replacement acts in the same way as naturally produced G-CSF by encouraging the bone marrow to produce more white blood cells.
Il- materjal trapjantabbli jaħdem bl- istess mod bħal dak prodott naturali G- CSF billi jinkoraġġixxi l- mudullum sabiex jipproduċi aktar ċelloli bojod tad- demm.
How has Filgrastim Hexal been studied?
Kif ġie studjat Filgrastim Hexal?
Filgrastim Hexal was studied to show that it is comparable to the reference medicine, Neupogen.
Filgrastim Hexal ġie studjat biex jiġi muri li huwa komparabbli mal- mediċina ta ’ referenza, Neupogen.
Four studies looked at the levels of neutrophils in the blood in a total of 146 healthy volunteers who received Filgrastim Hexal or Neupogen.
Erba ’ studji ħarsu lejn il- livelli ta ’ newtrofils fid- demm f’ total ta ’ 146 voluntiera b’ saħħithom li rċevew Filgrastim Hexal jew Neupogen.
The studies looked at the effects of single and repeated administration of various doses of the medicines, either injected under the skin or infused into a vein.
L- istudji ħarsu lejn l- effetti ta ’ amministrazzjoni ta ’ darba u repetuta f’ dożi varji tal- mediċini, kemm dawk injettati taħt il- ġilda jew infużi fil- vina.
The main measure in these studies was the neutrophil count over the first 10 days of treatment.
Il- kejl prinċipali f’ dawn l- istudji kien in- numru ta ’ newtrofil fuq l- ewwel 10 ijiem ta ’ trattament.
What benefit has Filgrastim Hexal shown during the studies?
X’ benefiċċju wera Filgrastim Hexal waqt l- istudji?
Filgrastim Hexal and Neupogen brought about similar increases in blood neutrophil counts in healthy volunteers over the course of the studies.
Filgrastim Hexal u Neupogen ġabu żjiediet simili ta ’ numru ta ’ newtrofil fid- demm f’ voluntiera b’ saħħithom matul l- istudji.
This was considered sufficient to demonstrate that the benefits of Filgrastim Hexal are comparable to those of the reference medicine.
Dan kien ikkunsidrat suffiċjenti sabiex juri li l- benefiċċji ta ’ Filgrastim Hexal jistgħu jiġu mqabbla ma ’ dawk tal- mediċina ta ’ referenza.
What is the risk associated with Filgrastim Hexal?
X’ inhu r- riskju assoċjat ma ’ Filgrastim Hexal?
The most common side effect with Filgrastim Hexal (seen in more than 1 patient in 10) is musculoskeletal pain (pain in the muscles and bones).
X' inhu r- riskju assoċjat ma 'Filgrastim Hexal (li deher f' iktar minn pazjent wieħed minn kull għaxra) hu uġiegħ muskoloskeletali (uġigħ fil- muskoli u fl- għadam).
Other side effects may be seen in more than 1 patient in 10, depending on the condition that Filgrastim Hexal is being used for.
Effetti sekondarji oħrajn jistgħu jidhru f’ aktar minn pazjent minn għaxra skond il- kondizzjoni li Filgrastim Hexal jkun użat għaliha.
For the full list of all side effects reported with Filgrastim Hexal, see the Package Leaflet.
Għal - lista sħiħa tal- effetti sekondarji rrapportati b' Filgrastim Hexal, ara l- Fuljett ta 'Tagħrif.
Filgrastim Hexal should not be used in people who may be hypersensitive (allergic) to filgrastim or any of the other ingredients.
Filgrastim Hexal m’ għandux jintuża minn persuni ipersensittivi (allerġiċi) għal filgrastim jew għal xi ingredjenti oħra tiegħu.
Why has Filgrastim Hexal been approved?
Għaliex ġie approvat Filgrastim Hexal?
The Committee for Medicinal Products for Human Use (CHMP) decided that, in accordance with EU requirements, Filgrastim Hexal has been shown to have a comparable quality, safety and efficacy profile to Neupogen.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) ikkunsidra li, b’ mod konformi mal- ħtiġijiet tal- Unjoni Ewropea, Filgrastim Hexal wera li għandu kwalità, sigurtà u effikaċja komparabbli ma ’ dawk ta ’ Neupogen.
Therefore, the CHMP’ s view was that, as for Neupogen, the benefit outweighs the identified risk.
Għaldaqstant, il- fehma tas- CHMP kienet li, bħal Neupogen, il - benefiċċji jegħlbu r- riskji identifikati.
The Committee recommended that Filgrastim Hexal be given marketing authorisation.
Il- Kumitat irrakkomanda li Filgrastim Hexal jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Filgrastim Hexal:
Informazzjoni oħra dwar Filgrastim Hexal:
The European Commission granted a marketing authorisation valid throughout the EU for Filgrastim Hexal to Hexal AG on 06 February 2009.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fuq is- suq madwar l- Unjoni Ewropea, għal Filgrastim Hexal lil Hexal AG fil- 06 ta ’ Frar 2009.
The full EPAR for Filgrastim Hexal can be found here.
L- EPAR sħiħ għal Filgrastim Hexal jista ’ jiġi kkonsultat hawnhekk.
EU Number
Kontenut Numru ta ’ l- EU
Content
(konċentrazzjoni)
Subcutaneous or intravenous use
Użu għal taħt il - ġilda jew ġol- vini
Pre-filled Syringe (glass)
Siringa mimlija għal- lest (ħġieġ)
1 pre-filled syringe
1 siringa mimlija għal- lest
3 pre-filled syringes
3 siringi mimlija għal- lest
5 pre-filled syringes
5 siringi mimlija għal- lest
10 pre-filled syringes
10 siringi mimlija għal- lest
Filgrastim HEXAL 30 MU/ 0.5 ml solution for injection or infusion in pre-filled syringe
Filgrastim HEXAL 30 MU/ 0. 5 ml soluzzjoni għall- injezzjoni jew infużjoni f’ siringa mimlija għal- lest
Each ml of solution contains 60 million units (MU) [equivalent to 600 micrograms (μ g)] filgrastim*.
Kull ml ta ’ soluzzjoni fih 60 miljun unità (MU) [ekwivalenti għal 600 mikrogramma (μg)] ta ’ filgrastim *.
Each pre-filled syringe contains 30 MU (equivalent to 300 μ g) filgrastim in 0.5 ml.
Kull siringa mimlija għal- lest fiha 30 MU (ekwivalenti għal 300 μg) ta ’ filgrastim f’ 0. 5 ml.
* recombinant methionylated human granulocyte-colony stimulating factor (G-CSF) produced in E. coli by recombinant DNA technology.
* recombinant methionylated human granulocyte- colony stimulating factor (G- CSF) magħmul f’ E. coli b’ teknoloġija tad- DNA rikombonanti.
Each ml of solution contains 50 mg sorbitol (E420).
Kull ml ta ’ soluzzjoni fih 50 mg ta ’ sorbitol (E420).
Solution for injection or infusion in pre-filled syringe
Soluzzjoni għall- injezzjoni jew infużjoni f’ siringa mimlija għal- lest
Clear, colourless to slightly yellowish solution.
Soluzzjoni ċara, bla kulur jew ta ’ kulur kemm kemm isfar.
- Reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients
- It- tnaqqis fit- tul ta ’ żmien ta ’ newtropenja u l- inċidenza ta ’ newtropenja bid- deni f’ pazjenti
treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes) and reduction in the duration of neutropenia in patients undergoing myeloablative therapy followed by bone marrow transplantation considered to be at increased risk of prolonged severe neutropenia.
kkurati b’ kimoterapija ċitotossika stabbilita għal malinn (bl- eċċezzjoni ta ’ lewkimja majelojde kronika u sindromi majelodisplastiċi) u tnaqqis fit- tul ta ’ żmien ta ’ newtropenja f’ pazjenti li jkollhom terapija majeloablattiva segwita minn trapjant tal- mudullun li huma kkunsidrati li jkunu f’ riskju miżjud ta ’ newtropenja severa għal żmien twil.
The safety and efficacy of filgrastim are similar in adults and children receiving cytotoxic chemotherapy.
Is- sigurtà u l- effikaċja ta ’ filgrastim huma simili fl- adulti u t- tfal li jkunu qed jirċievu l - kimoterapija ċitotossika.
- Mobilisation of peripheral blood progenitor cells (PBPC).
- Il- mobilizzazzjoni ta ’ ċelluli proġenituri tad- demm periferali (PBPC).
- In children and adults with severe congenital, cyclic, or idiopathic neutropenia with an absolute
- Fi tfal u adulti b’ newtropenja severa konġenitali, ċiklika, jew idjopatika b’ għadd assolut tan -
neutrophil count (ANC) of ≤ 0.5 x 109/ l, and a history of severe or recurrent infections, long term administration of filgrastim is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events.
newtrofili (ANC) ta ’ ≤ 0. 5 x 109/ l, u storja medika ta ’ infezzjonijiet severi jew rikorrenti, l- għoti fit- tul ta ’ filgrastim hu indikat biex iżid l- għadd tan- newtrofili u biex inaqqas l- inċidenza u t- tul ta ’ żmien ta ’ avvenimenti assoċjati mal- infezzjoni.
- Treatment of persistent neutropenia (ANC ≤ 1.0 x 109/ l) in patients with advanced HIV
Il- kura ta ’ newtropenja persistenti (ANC ≤ 1. 0 x 109/ l) f’ pazjenti b’ infezzjoni avvanzata tal -
infection, in order to reduce the risk of bacterial infections when other therapeutic options are inappropriate.
HIV, sabiex jitnaqqas ir- riskju ta ’ infezzjonijiet batterjali meta għażliet terapewtiċi oħrajn ma jkunux adattati.
Filgrastim therapy should only be given in collaboration with an oncology centre which has experience in granulocyte-colony stimulating factor (G-CSF) treatment and haematology and has the necessary diagnostic facilities.
It- terapija b’ filgrastim għandha tingħata biss b’ kollaborazzjoni ma ’ ċentru ta ’ onkoloġija li jkollu l - esperjenza fil- kura u l- ematoloġija tal- fattur tal- istimulazzjoni tal- kolonji tal- granuloċiti (G- CSF) u li jkollu l- faċilitajiet dijanjostiċi meħtieġa.
2 The mobilisation and apheresis procedures should be performed in collaboration with an oncology-haematology centre with acceptable experience in this field and where the monitoring of haematopoietic progenitor cells can be correctly performed.
Il- proċeduri tal- mobilizzazzjoni u l- aferesi għandhom jitwettqu b’ kollaborazzjoni ma ’ ċentru tal - onkoloġija- ematolġija b’ esperjenza aċċettabbli f’ dan il- qasam u fejn il- monitoraġġ taċ- ċelluli ematopojetiċi proġenituri jkun jista ’ jitwettaq b’ mod korrett.
Filgrastim HEXAL is available in strengths of 30 MU/ 0.5 ml and 48 MU/ 0.5 ml.
2 Filgrastim HEXAL hu disponibbli fil- qawwiet ta ’ 30 MU/ 0. 5 ml u 48 MU/ 0. 5 ml.
The recommended dose of filgrastim is 0.5 MU/ kg/ day (5 μ g/ kg/ day).
Id- doża rakkomandata ta ’ filgrastim hi ta ’ 0. 5 MU/ kg/ kuljum (5 μg/ kg/ kuljum).
The first dose of filgrastim should not be administered less than 24 hours following cytotoxic chemotherapy.
L- ewwel doża ta ’ filgrastim m’ għandhiex tingħata inqas minn 24 siegħa wara l- kimoterapija ċitotossika.
Daily dosing with filgrastim should continue until the expected neutrophil nadir is passed and the neutrophil count has recovered to the normal range.
Id- dożaġġ ta ’ kuljum b’ filgrastim għandu jitkompla sakemm l- għadd minimu mistenni tan- newtrofili jkun għadda u l- għadd tan- newtrofili jkun irkupra għall- medda normali.
Following established chemotherapy for solid tumours, lymphomas, and lymphoid leukaemias, it is expected that the duration of treatment required to fulfil these criteria will be up to 14 days.
Wara kimoterapija stabbilita għal tumuri solidi, limfomi, u lewkimji limfojde, hu mistenni li t- tul ta ’ żmien tal- kura meħtieġa biex dawn il- kriterji jintlaħqu ser ikun sa 14- il jum.
Following induction and consolidation treatment for acute myeloid leukaemia the duration of treatment may be substantially longer (up to 38 days) depending on the type, dose and schedule of cytotoxic chemotherapy used.
Wara l- induzzjoni u l- kura ta ’ konsolidazzjoni għal lewkimja majelojde akuta, it- tul ta ’ żmien tal- kura jista ’ jkun itwal b’ mod sostanzjali (sa 38 jum) skont it- tip, id- doża u l- iskeda tal- kimoterapija ċitotossika użati.
In patients receiving cytotoxic chemotherapy, a transient increase in neutrophil counts is typically seen 1 - 2 days after initiation of filgrastim therapy.
F’ pazjenti li jkunu qed jirċievu l- kimoterapija ċitotossika, żieda temporanja fl- għadd tan- newtrofili tipikament tiġi osservata minn jum sa jumejn wara l- bidu tat- terapija b’ filgrastim.
However, for a sustained therapeutic response, filgrastim therapy should not be discontinued before the expected nadir has passed and the neutrophil count has recovered to the normal range.
Madankollu, għal rispons terapewtiku sostnut, it- terapija b’ filgrastim m’ għandhiex titwaqqaf qabel il- punt minimu mistenni jkun għadda u l- għadd tan- newtrofili ikun irkuprat għall- medda normali.
Premature discontinuation of filgrastim therapy, prior to the time of the expected neutrophil nadir, is not recommended.
It- twaqqif prematur tat- terapija b’ filgrastim, qabel iż- żmien tal- għadd minimu mistenni tan- newtrofili, mhuwiex rakkomandat.
Patients treated with myeloablative therapy followed by bone marrow transplantation The recommended starting dose of filgrastim is 1.0 MU/ kg/ day (10 μ g/ kg/ day).
Pazjenti kkurati b’ terapija majeloablattiva segwita minn trapjant tal- mudullun Id- doża tal- bidu rakkomandata ta ’ filgrastim hi ta ’ 1. 0 MU/ kg/ kuljum (10 μg/ kg/ kuljum).
The first dose of filgrastim should not be administered less than 24 hours following cytotoxic chemotherapy and within 24 hours of bone marrow infusion.
L- ewwel doża ta ’ filgrastim m’ għandhiex tingħata inqas minn 24 siegħa wara l- kimoterapija ċitotossika u fi żmien 24 siegħa mill- infużjoni tal- mudullun.
Dose adjustments:
Aġġustamenti fid- doża:
Once the neutrophil nadir has been passed, the daily dose of filgrastim should be titrated against the neutrophil response as follows:
Ġaladarba l- għadd minimu tan- newtrofili jkun għadda, id- doża ta ’ kuljum ta ’ filgrastim għandha tkun ittritata kontra r- rispons tan- newtrofili kif ġej:
Absolute neutrophil count ANC > 1.0 x 109/ l for 3 consecutive days Then, if ANC remains > 1.0 x 109/ l for 3 more consecutive days
Għadd assolut tan- newtrofili ANC > 1. 0 x 109/ l għal 3 jiem konsekuttivi Imbagħad, jekk l- ANC jibqa ’ > 1. 0 x 109/ l
Filgrastim dose adjustment Reduce to 0.5 MU/ kg/ day (5 μ g/ kg/ day) Discontinue filgrastim
Aġġustament fid- doża ta ’ Filgrastim Naqqas għal 0. 5 MU/ kg/ kuljum (5 μg/ kg/ kuljum)
If the ANC decreases to < 1.0 x 109/ l during the treatment period, the dose of filgrastim should be re-escalated according to the above steps
Waqqaf filgrastim għal 3 ijiem konsekuttivi iktar Jekk l- ANC jonqos għal < 1. 0 x 109/ l matul il- perjodu tal- kura, id- doża ta ’ filgrastim għandha tiżdied mill- ġdid skont il- passi t’ hawn fuq
Mobilisation of PBPC
Mobilizzazzjoni tal- PBPC
Patients undergoing myelosuppressive or myeloablative therapy followed by autologous PBPC transplantation The recommended dose of filgrastim for PBPC mobilisation when used alone is 1.0 MU/ kg/ day (10 μ g/ kg/ day) for 5 - 7 consecutive days.
Pazjenti li jkunu qed jagħmlu terapija majelosoppressiva jew majeloablattiva segwita minn trapjant PBPC awtologu Id- doża rakkomandata ta ’ filgrastim għal mobilizzazzjoni tal- PBPC meta jintuża waħdu hi ta ’ 1. 0 MU/ kg/ kuljum (10 μg/ kg/ kuljum) għal 5 - 7 t’ ijiem konsekuttivi.
Timing of leukapheresis:
Meta tingħata l- lewkaferesi:
1 or 2 leukaphereses on days 5 and 6 are often sufficient.
1 jew 2 lewkaferesi f’ jiem 5 u 6 ta ’ spiss ikunu suffiċjenti.
In other circumstances, additional leukaphereses may be necessary.
F’ ċirkustanzi oħra, jista ’ jkun hemm bżonn ta ’ lewkaferesi addizzjonali.
Filgrastim dosing should be maintained until the last leukapheresis.
Id- dożaġġ ta ’ filgrastim għandu jinżamm sal- aħħar lewkaferesi.
The recommended dose of filgrastim for PBPC mobilisation after myelosuppressive chemotherapy is 0.5 MU/ kg/ day (5 μ g/ kg/ day) given daily from the first day after completion of chemotherapy until the expected neutrophil nadir is passed and the neutrophil count has recovered to the normal range.
Id- doża rakkomandata ta ’ filgrastim għal mobilizzazzjoni tal- PBPC wara kimoterapija majelosoppressiva hi ta ’ 0. 5 MU/ kg/ kuljum (5 μg/ kg/ kuljum) mogħtija kuljum mill- ewwel jum wara t - tlestija tal- kimoterapija sakemm l- għadd minimu mistenni tan- newtrofili jkun għadda u l- għadd tan - newtrofili jkun irkupra għal medda normali.
Leukapheresis should be performed during the period when the ANC rises from< 0.5 x 109/l to > 5.0 x 109/l.
Il- lewkaferesi għandha titwettaq matul il- perjodu meta l - ANC jitla ’ minn < 0. 5 x 109/ l għal > 5. 0 x 109/ l.
For patients who have not had extensive chemotherapy, one leukapheresis is often sufficient.
Għal pazjenti li ma kellhomx kimoterapija estensiva, lewkaferesi waħda ta ’ spiss tkun suffiċjenti.
In other circumstances, additional leukaphereses are recommended.
F’ ċirkustanzi oħrajn, lewkaferesi addizzjonali huma rakkomandati.
There are no prospectively randomised comparisons of the two recommended mobilisation methods (filgrastim alone or in combination with myelosuppressive chemotherapy) within the same patient population.
M’ hemm l- ebda paraguni prospettivi randomised taż- żewġ metodi tal- mobilizzazzjoni rakkomandata (filgrastim waħdu jew flimkien mal- kimoterapija majelosoppressiva) fl- istess popolazzjoni ta ’ pazjenti.
The degree of variation between individual patients and between laboratory assays of
Il- grad ta ’ varjazzjoni bejn pazjenti individwali u bejn l- assaġġi tal- laboratorju ta ’ ċelluli CD34+ ifisser li paragun dirett bejn studji differenti hu diffiċli.
3 CD34+ cells means that direct comparison between different studies is difficult.
3 aħjar metodu.
The choice of mobilisation method should be considered in relation to the overall objectives of treatment for an individual patient.
L- għażla tal- metodu mobilizzazzjoni għandu jiġi kkunsidrat fir- rigward tal- objettivi totali tal- kura għal pazjent individwali.
Normal donors prior to allogeneic PBPC transplantation For PBPC mobilisation in normal donors prior to allogeneic PBPC transplantation, filgrastim should be administered at 1.0 MU/ kg/ day (10 μ g/ kg/ day) for 4 - 5 consecutive days.
Donaturi normali qabel trapjant alloġeneiku tal- PBPC Għal mobilizzazzjoni tal- PBPC f’ donaturi normali qabel trapjant tal- PBPC alloġeneiku, filgrastim għandu jingħata f’ doża ta ’ 1. 0 MU/ kg/ kuljum (10 μg/ kg/ kuljum) għal 4 – 5 t ’ ijiem konsekuttivi.
Leukapheresis should be started at day 5 and continued until day 6 if needed in order to collect 4 x 106 CD34+ cells/ kg recipient bodyweight (BW).
Il - lewkaferesi għandha tinbeda f’ jum 5 u titkompla sa jum 6 jekk meħtieġ sabiex tiġbor 4 x 106 CD34+ ċelluli/ kg ta ’ piż tal- ġisem (BW) tar- reċipjent.
Severe chronic neutropenia (SCN)
Newtropenja kronika severa (SCN)
Congenital neutropenia The recommended starting dose is 1.2 MU/ kg/ day (12 μ g/ kg/ day) as a single dose or in divided doses.
Newtropenja konġenitali Id- doża tal- bidu rakkomandata hi ta ’ 1. 2 MU/ kg/ kuljum (12 μg/ kg/ kuljum) bħala doża waħda jew dożi maqsumin.
Idiopathic or cyclic neutropenia The recommended starting dose is 0.5 MU/ kg/ day (5 μ g/ kg/ day) as a single dose or in divided doses.
Newtropenja idjopatika jew ċiklika Id- doża tal- bidu rakkomandata hi ta ’ 0. 5 MU/ kg/ kuljum (5 μg/ kg/ kuljum) bħala doża waħda jew dożi maqsumin.
Dose adjustments Filgrastim should be administered daily until the neutrophil count has reached and can be maintained at more than 1.5 x 109/ l.
Aġġustamenti fid- doża Filgrastim għandu jingħata kuljum sakemm l- għadd tan- newtrofili jilħaq u jkun jista ’ jinżamm f’ iktar minn 1. 5 x 109/ l.
When the response has been obtained, the minimal effective dose to maintain this level should be established.
Meta r- rispons ikun inkiseb, id- doża minima effettiva biex jinżamm dan il- livell għandha tiġi stabbilita.
Long-term daily administration is required to maintain an adequate neutrophil count.
L- għoti ta ’ kuljum għal tul ta ’ żmien hu meħtieġ biex iżomm għadd adegwat ta ’ newtrofili.
After 1 - 2 weeks of therapy, the initial dose may be doubled or halved depending upon the patient's response.
Wara ġimgħa jew tnejn ta ’ terapija, id- doża tal- bidu tista ’ tiġi rduppjata jew titnaqqas bin- nofs, skont ir- rispons tal- pazjent.
Subsequently the dose may be individually adjusted every 1 - 2 weeks to maintain the average neutrophil count between 1.5 x 109/ l and 10 x 109/ l.
Sussegwentement id- doża tista ’ tiġi aġġustata individwalment kull ġimgħa - ġimagħtejn biex iżżomm il- medja tal- għadd tan- newtrofili bejn 1. 5 x 109/ l u 10 x 109/ l.
A faster schedule of dose escalation may be considered in patients presenting with severe infections.
Skeda iktar mgħaġġla ta ’ żieda fid- doża tista ’ tkun ikkunsidrata f’ pazjenti li jkollhom infezzjonijiet severi.
In clinical studies, 97% of patients who responded had a complete response at doses of ≤ 2.4 MU/ kg/ day (24 μ g/ kg/ day).
Fi studji kliniċi, 97% tal- pazjenti li rrispondew kellhom rispons sħiħ f’ dożi ta ’ ≤ 2. 4 MU/ kg/ kuljum (24 μg/ kg/ kuljum).
The long-term safety of filgrastim administration above 2.4 MU/ kg/ day (24 μ g/ kg/ day) in patients with SCN has not been established.
Is- sigurtà fit- tul tal- għoti ta ’ filgrastim f’ iktar minn 2. 4 MU/ kg/ kuljum (24 μg/ kg/ kuljum) f’ pazjenti b’ SCN ma kinitx stabbilita.
HIV infection
Infezzjoni bl- HIV
Reversal of neutropenia The recommended starting dose of filgrastim is 0.1 MU/ kg/ day (1 μ g/ kg/ day) given daily with titration up to a maximum of 0.4 MU/ kg/ day (4 μ g/ kg/ day) until a normal neutrophil count is reached and can be maintained (ANC > 2.0 x 109/ l).
It- treġġigħ lura ta ’ newtropenja Id- doża tal- bidu rakkomandata ta ’ filgrastim hi ta ’ 0. 1 MU/ kg/ kuljum (1 μg/ kg/ kuljum) mogħtija kuljum b’ titrazzjoni sa massimu ta ’ 0. 4 MU/ kg/ kuljum (4 μg/ kg/ kuljum) sakemm jintlaħaq għadd normali ta ’ newtrofili u jkun jista ’ jinżamm (ANC > 2. 0 x 109/ l).
In clinical studies, > 90% of patients responded at these doses, achieving reversal of neutropenia in a median of 2 days.
Fi studji kliniċi, > 90% tal- pazjenti rrispondew f’ dawn id- dożi, u kisbu t- treġġigħ lura tan- newtropenja f’ medjan ta ’ jumejn.
In a small number of patients (< 10%), doses up to 1.0 MU/ kg/ day (10 μ g/ kg/ day) were required to achieve reversal of neutropenia.
F’ numru żgħir ta ’ pazjenti (< 10%), dożi sa 1. 0 MU/ kg/ kuljum (10 μg/ kg/ kuljum) kienu meħtieġa biex iwettqu t- treġġigħ lura tan- newtropenja.
Maintenance of normal neutrophil counts When reversal of neutropenia has been achieved, the minimal effective dose to maintain a normal neutrophil count should be established.
Il- manteniment tal- għadd normali tan- newtrofili Meta jkun inkiseb it- treġġigħ lura tan- newtropenja, id- doża effettiva minima biex iżżomm għadd normali ta ’ newtrofili għandha tiġi stabbilita.
Initial dose adjustment to alternate day dosing with 30 MU/ day (300 μ g/ day) is recommended.
L- aġġustament fid- doża tal- bidu għal dożaġġ kull jumejn bi 30 MU/ kuljum (300 μg/ kuljum) hu rakkomandat.
Further dose adjustment may be necessary, as determined by the patient's ANC, to maintain the neutrophil count at > 2.0 x 109/ l.
Aġġustament addizzjonali fid- doża jista ’ jkun meħtieġ, kif stabbilit mill- ANC tal- pazjent, biex jinżamm l- għadd tan- newtrofili f ’ > 2. 0 x 109/ l.
In clinical studies, dosing with 30 MU/ day (300 μ g/ day) on 1 - 7 days per week was required to maintain the ANC > 2.0 x 109/ l, with the median dose frequency being 3 days per week.
Fi studji kliniċi, dożaġġ bi 30 MU/ kuljum (300 μg/ kuljum) fuq perjodu ta ’ 1 - 7 ijiem kull ġimgħa kien meħtieġ biex iżomm l- ANC > 2. 0 x 109/ l, bil- medjan tal- frekwenza tad- doża li tkun ta ’ 3 t’ ijiem kull ġimgħa.
Long-term administration may be required to maintain the ANC > 2.0 x 109/ l.
L- għoti fit- tul jista ’ jkun meħtieġ biex iżomm l- ANC f ’ > 2. 0 x 109/ l.
Patients with renal/ hepatic impairment Studies of filgrastim in patients with severe impairment of renal or hepatic function demonstrate that it exhibits a similar pharmacokinetic and pharmacodynamic profile to that seen in normal individuals.
Pazjenti b’ indeboliment renali/ epatiku Studji dwar filgrastim f’ pazjenti b’ indeboliment sever tal- funzjoni renali jew epatika juru profil farmakokinetiku u farmakodinamiku li hu simili bħal dak li jkun osservat f’ individwi normali.
Dose adjustment is not required in these circumstances.
L- ebda aġġustament fid- doża mhu meħtieġ f’ dawn iċ- ċirkustanzi.
4 Paediatric patients in the SCN and cancer settings In clinical studies 65% of patients treated for SCN were younger than 18 years.
4 Pazjenti pedjatriċi li għandhom SCN u kanċer Fi studji kliniċi 65% ta ’ pazjenti kkurati għal SCN kellhom inqas minn 18- il sena.
For this age-group, which mostly includes patients with congenital neutropenia, efficacy was proven.
Għal dan il- grupp ta ’ età, li fil- biċċa l- kbira tiegħu jinkludi pazjenti b’ newtropenja konġenitali, l- effikaċja kienet ippruvata.
There were no differences in the safety profiles for paediatric patients treated for SCN in comparison to adults.
Ma kien hemm l- ebda differenzi fil- profil tas- sigurtà għal pazjenti pedjatriċi kkurati għal SCN meta mqabbel mal- adulti.
Data from clinical studies in paediatric patients indicate that the safety and efficacy of filgrastim are similar in both adults and children receiving cytotoxic chemotherapy.
Dejta minn studji kliniċi f’ pazjenti pedjatriċi tindika li s- sigurtà u l- effikaċja ta ’ filgrastim huma simili kemm fl- adulti kif ukoll fit- tfal li jkunu qed jirċievu kimoterapija ċitotossika.
The dosage recommendations in paediatric patients are the same as those in adults receiving myelosuppressive cytotoxic chemotherapy.
Ir- rakkomandazzjonijiet tad- dożaġġ f’ pazjenti pedjatriċi huma l- istess bħal dawk fl- adulti li jkunu qed jirċievu kimoterapija ċitotossika majelosoppressiva.
Elderly patients In clinical investigations with filgrastim a small number of elderly patients was included.
Pazjenti anzjani F’ investigazzjonijiet kliniċi b’ filgrastim, numru żgħir ta ’ pazjenti anzjani kienu inklużi.
No specific studies have been performed for this patient population.
Ma saru l - ebda studji specifiċi għal din il- popolazzjoni ta ’ pazjenti.
Therefore, specific posology recommendations for these patients cannot be made.
Għalhekk, ma jistgħux isiru rakkomandazzjonijiet speċifiċi dwar il- pożoloġija.
Established cytotoxic chemotherapy Filgrastim may be administered as a daily subcutaneous injection or alternatively as a daily intravenous infusion over 30 minutes.
Kimoterapija ċitotossika stabbilita Filgrastim jista ’ jingħata bħala injezzjoni ta ’ kuljum taħt il- ġilda jew alternattivament bħala infużjoni ta ’ kuljum ġol- vini fuq perjodu ta ’ 30 minuta.
For further instructions on dilution with glucose 50 mg/ ml (5%) solution prior to infusion see section 6.6.
Għal struzzjonijiet addizzjonali fuq id- dilwizzjoni b’ soluzzjoni ta ’ 50 mg/ ml (5%) ta ’ glucose qabel l- infużjoni, ara sezzjoni 6. 6.
The subcutaneous route is preferred in most cases.
L- għoti taħt il- ġilda hu ppreferut fil- biċċa l- kbira tal- każijiet.
There is some evidence from a study of single dose administration that intravenous dosing may shorten the duration of effect.
Hemm xi evidenza minn studju dwar l- għoti ta ’ doża waħda li d - dożaġġ ġol- vini jista ’ jqassar it- tul tal- effett.
The clinical relevance of this finding to multiple dose administration is not clear.
Ir- rilevanza klinika ta ’ din is- sejba fir- rigward tal- għoti ta ’ dożi multipli mhijiex ċara.
The choice of route should depend on the individual clinical circumstance.
L- għażla tal- mod tal- għoti għandha tiddependi fuq iċ- ċirkustanzi kliniċi individwali.
In randomised clinical studies, a subcutaneous dose of 23 MU/ m2/ day (230 μ g/ m2/ day) or rather 0.4 - 0.84 MU/ kg/ day (4 - 8.4 μ g/ kg/ day) was used.
Fi studji kliniċi randomised, doża taħt il- ġilda ta ’ 23 MU/ m2/ kuljum (230 μg/ m2/ kuljum) jew 0. 4 - 0. 84 MU/ kg/ kuljum (4 - 8. 4 μg/ kg/ kuljum) intużat.
Patients treated with myeloablative therapy followed by bone marrow transplantation Filgrastim is administered as an intravenous short-term infusion over 30 minutes or as a subcutaneous or intravenous continuous infusion over 24 hours, in each case after dilution in 20 ml of glucose 50 mg/ ml (5%) solution.
Pazjenti kkurati b’ terapija majeloablattiva segwita minn trapjant tal- mudullun Filgrastim jingħata bħala infużjoni qasira ġol- vini fuq perjodu ta ’ 30 minuta jew bħala infużjoni kontinwa taħt il- ġilda jew ġol- vini fuq perjodu ta ’ 24 siegħa, f’ kull każ wara d- dilwizzjoni f’ 20 ml ta ’ soluzzjoni ta ’ 50 mg/ ml (5%) ta ’ glucose.