qanastek/EMEA-V3 huggingface dataset:
It is quite normal to have several courses of treatment with Filgrastim HEXAL.
Hu normali għal kollox li jkollok diversi korsijiet tal- kura b’ Filgrastim HEXAL.
Like all medicines, Filgrastim HEXAL can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Filgrastim HEXAL jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Tell your doctor immediately • if you experience a cough, fever and difficulty breathing since you may develop severe pulmonary side effects like pneumonia and respiratory distress; • if you get pain in the upper left side of your stomach or pain at the tip of your shoulder since this may relate to a problem with your spleen; • if you have sudden difficulty breathing or dizziness, swelling of your face or throat, skin weals or rash.
Għid lit- tabib tiegħek immedjatament • Jekk ikollok sogħla, deni u diffikultà biex tieħu n- nifs, għax tista ’ tiżviluppa effetti sekondarji pulmonari bħal pnewmonja u problemi respiratorji; • jekk ikollok uġigħ fin- naħa ta ’ fuq tax- xellug tal- istonku jew uġigħ fit- tarf ta ’ spallejk, għax dan jista ’ jkun relatat ma ’ problema fil- milsa tiegħek; • jekk ikollok diffikultà għal għarrieda biex tieħu n- nifs jew sturdament, nefħa ta ’ wiċċek jew fil - gerżuma, wheals jew raxx tal- ġilda.
As this may be a serious allergic reaction, stop your injection and get medical help immediately.
Minħabba li din tista ’ tkun reazzjoni allerġika, waqqaf l - injezzjoni tiegħek u ikseb għajnuna medika immedjatament.
Side effects may occur with certain frequencies, which are defined as follows: • very common: affects more than 1 user in 10 • common: affects 1 to 10 users in 100 • uncommon: affects 1 to 10 users in 1,000 • rare: affects 1 to 10 users in 10,000 • very rare: affects less than 1 user in 10,000 • not known: frequency cannot be estimated from the available data.
Dawn l- effetti sekondarji jistgħu jseħħu b’ ċerti frekwenzi, li huma definiti kif ġej: • komuni ħafna: jaffettwaw iktar minn utent 1 minn kull 10 • komuni: jaffettwaw minn 1 sa 10 utenti minn kull 100 • mhux komuni: jaffettwaw minn 1 sa 10 utenti minn kull 1, 000 • rari: jaffettwaw minn 1 sa 10 utenti minn kull 10, 000 • rari ħafna: jaffettwaw inqas minn utent 1 minn kull 10, 000 • mhux magħrufa: ma tistax tittieħed stima mid- data disponibbli.
Very common side effects • bone, joint and muscle pain • elevations in blood levels of uric acid and certain enzymes • decreases in blood glucose • leukocytosis (an abnormally high number of white blood cells in the blood) • low level of blood platelets (which increases risk of bleeding or bruising) • low level of red blood cells (which can make the skin pale and cause weakness and breathlessness) • headache • nose bleed • enlarged spleen
Effetti sekondarji komuni ħafna • uġigħ fl- għadam, fil- ġogi u fil- muskoli, • żidiet ħfief jew moderati fil- livelli fid- demm ta ’ uric acid u ċerti enzimi • tnaqqis fil- glucose fid- demm • lewkoċitosi (numru għoli anormali ta ’ ċelluli bojod tad- demm fid- demm) • livell baxx plejtlits fid- demm (li jżid ir- riskju ta ’ ħruġ ta ’ demm jew tbenġil) • livell baxx ta ’ ċelluli ħomor tad- demm (li jistgħu jagħmlu l- ġilda pallida u jikkawża dgħjufija u qtugħ ta ’ nifs) • uġigħ ta ’ ras • tinfaraġ • tkabbir tal- milsa
Common side effects • diarrhoea • injection site pain • hair loss • rash • enlarged liver • inflammation of blood vessels of the skin • loss of calcium from the bones (osteoporosis) • spleen disorder
55 Effetti sekondarji komuni • dijarea • uġigħ fis- sit tal- injezzjoni • telf ta ’ xagħar • raxx • il- fwied jikber • infjammazzjoni tal- vini jew arterji fil- ġilda • telf ta ’ calcium mill- għadam (osteoporożi) • disturbi fil- milsa
55 Uncommon side effects • decrease in blood pressure • allergic-type reactions, including anaphylaxis (dizziness, severe drop in blood pressure, difficulty in breathing), angioedema (painful swelling of the face or throat), difficulty in breathing, low blood pressure, skin rash, nettle rash; these reactions can occur at the start of the treatment or throughout the treatment • worsening of rheumatoid arthritis or arthritic symptoms • blood or protein in the urine
Effetti sekondarji mhux komuni • tnaqqis fil- pressjoni tad- demm • reazzjonijiet qishom allerġija, li jinkludu anafilassi (sturdament, tnaqqis sever fil- pressjoni tad - demm, diffikultà biex tieħu n- nifs), anġjoedema (nefħa bl- uġigħ tal- wiċċ jew tal- gerżuma), diffikultà biex tieħu n- nifs, pressjoni tad- demm baxxa, raxx tal- ġilda, jew raxx bħal dak ikkawżat mill- ħurrieq; dawn ir- reazzjonijiet jistgħu jseħħu fil- bidu tal- kura jew matul il- kura • aggravament ta ’ artrite rewmatojde jew sintomi artritiċi • demm jew proteina fl- awrina
Rare side effects • vascular disorders, including venoocclusive disease (a disease which affects the liver) and water retention, which can cause swelling in the limbs
Effetti sekondarji rari • disturbi vaskulari, li jinkludu mard veno- okklużiv (marda li taffettwa l- fwied) u disturbi fil- volum tal- fluwidu u żamma tal- ilma li tista 'tikkawża nefħa fid- dirgħajn/ riġlejn
Very rare side effects • difficulties in passing urine • Sweet's syndrome (plum-coloured, raised, painful lesions on the limbs, sometimes the face and neck, with fever) • water retention in the lungs, bleeding in the lungs, coughing up of blood, lack of oxygen, inflammation of the lungs (which can cause breathlessness, cough, raised temperature); in some cases, this could lead to respiratory failure or adult respiratory distress syndrome (ARDS, a condition causing increased shortness of breath, in very ill patients), which may be fatal • sickle cell crises (acute collapse of red blood cells) in patients with sickle cell disease • rupture of the spleen
Effetti sekondarji rari ħafna • diffikultajiet biex tagħmel l- awrina • Is- sindrome ta ’ Sweet (leżjonijiet minfuħin ta ’ kulur l- għajnbaqar bl- uġigħ fuq id- dirgħajn/ riġlejn, xi kultant fil- wiċċ u fl- għonq, b’ deni) • Żamma tal- ilma fil- pulmuni, ħruġ ta ’ demm fil- pulmuni, tisghol id- demm, nuqqas ta ’ ossiġnu, infjammazzjoni tal- pulmun (li tista ’ tikkawża qtugħ ta ’ nifs, sogħla, temperatura għolja); f’ xi każijiet, dan jista ’ jwassal għal waqfien tan- nifs jew is- sindrome ta ’ problemi respiratorji fl- adulti (ARDS, kundizzjoni li tikkawża żieda fil- qtugħ tan- nifs, f’ pazjenti morda ħafna), li tista ’ tkun fatali • kriżijiet taċ- ċelluli sickle (kollass akut taċ- ċelluli ħomor tad- demm) f’ pazjenti bil- marda taċ- ċelluli sickle • il- milsa tinfaqa ’
HOW TO STORE FILGRASTIM HEXAL
KIF TAĦŻEN FILGRASTIM HEXAL
Do not use Filgrastim HEXAL after the expiry date which is stated on the carton and on the syringe label after EXP.
Tużax Filgrastim HEXAL wara d- data ta ’ skadenza li tidher fuq il- kartuna fuq it- tikketta tas- siringa wara EXP.
What Filgrastim HEXAL contains
X’ fih Filgrastim HEXAL
- The active substance is filgrastim.
- Is- sustanza attiva hi filgrastim.
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 pre-filled syringe contains 30 MU filgrastim in 0.5 ml, corresponding to 60 MU/ ml.
Kull siringa mimlija għal- lest fiha 30 MU ta ’ filgrastim f’ 0. 5 ml li jikkorrispondi għal 60 MU/ ml.
Filgrastim HEXAL 48 MU/ 0.5 ml solution for injection or infusion in pre-filled syringe:
Filgrastim HEXAL 48 MU/ 0. 5 ml soluzzjoni għall- injezzjoni jew infużjoni f’ siringa mimlija għal- lest:
Each pre-filled syringe contains 48 MU filgrastim in 0.5 ml, corresponding to 96 MU/ ml
Kull siringa mimlija għal- lest fiha 48 MU ta ’ filgrastim f’ 0. 5 ml li jikkorrispondi għal 96 MU/ ml.
- The other ingredients are glutamic acid, sorbitol (E420), polysorbate 80 and water for
- Is- sustanzi l- oħra huma glutamic acid, sorbitol (E420), polysorbate 80 u ilma għall -
56 What Filgrastim HEXAL looks like and contents of the pack
Id- Dehra ta ’ Filgrastim HEXAL u l- kontenuti tal- pakkett
Filgrastim HEXAL is a clear, colourless to slightly yellowish solution for injection or infusion in a pre-filled syringe.
Filgrastim HEXAL hu soluzzjoni ċara u bla kulur jew kemm kemm safra għall- injezzjoni f’ siringa mimlija għal- lest.
Filgrastim HEXAL is available in packs containing 1, 3, 5 or 10 pre-filled syringes with injection needle and with or without a needle safety guard.
Filgrastim HEXAL hu disponibbli f’ pakketti li fihom 1, 3, 5 jew 10 siringi mimlija għal- lest b’ labra tal- injezzjoni bi jew mingħajr protezzjoni tas- sigurtà tal- labra.
Not all pack sizes may be marketed.
Mhux id- daqsijiet kollha tal- pakketti jistgħu jitpoġġew fis- suq.
HEXAL AG Industriestrasse 25 D-83607 Holzkirchen Germany Tel: + 49 8024 908-0 Fax: + 49 8024 908-1290 e-mail: service@hexal. com
HEXAL AG Industriestrasse 25 D- 83607 Holzkirchen Il- Ġermanja Tel: + 49 8024 908- 0 Fax: + 49 8024 908- 1290 e- mail: service@ hexal. com
Sandoz GmbH Biochemiestrasse 10 A-6250 Kundl Austria
Sandoz GmbH Biochemiestrasse 10 A- 6250 Kundl L- Awstrija
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http: / /www. emea. europa. eu/
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il - Mediċini (EMEA): http: // www. emea. europa. eu /.
Instructions on how to inject yourself
Struzzjonijiet dwar kif tinjetta lilek innifsek
This section contains information on how to give yourself an injection of Filgrastim HEXAL.
Din is- sezzjoni fiha tagħrif dwar kif għandek tagħti injezzjoni ta ’ Filgrastim HEXAL lilek innifsek.
It is important that you do not try to give yourself the injection unless you have received special training from your doctor or nurse.
Huwa importanti li ma tippruvax tinjetta lilek innifsek ħlief jekk tkun ingħatajt taħriġ speċjali mingħand it- tabib jew l- infermiera tiegħek.
Filgrastim HEXAL is provided with or without a needle safety guard and you will be shown how to use this by your doctor or nurse.
Filgrastim HEXAL hu pprovdut bi jew mingħajr protezzjoni tas- sigurtà tal- labra, u t- tabib jew l- infermiera tiegħek ser juruk kif tużaha.
If you are not sure about giving the injection or you have any questions, please ask your doctor or nurse for help.
Jekk m’ intix ċert/ a dwar kif tinjetta, jew jekk ikollok xi mistoqsijiet, jekk jogħġbok staqsi it- tabib jew l- infermiera tiegħek biex jgħinuk.
How do I inject myself?
57 Kif ninjetta lili nnifsi?
You will need to give yourself an injection into the tissue under the skin, known as a subcutaneous injection.
Int ser ikollok bżonn tagħti injezzjoni lilek innifsek fit- tessut ta ’ taħt il- ġilda, magħrufa bħala injezzjoni subkutanea.
Your doctor or nurse will tell you how frequently it should be injected.
It- tabib jew l- infermiera tiegħek ser jgħidulek kemm- il darba għadha tiġi injettata.
What do I need?
X’ għandi bżonn?
To give yourself a subcutaneous injection you will need:
Biex tagħti lilek innifsek injezzjoni taħt il- ġilda, ser ikollok bzonn:
A new pre-filled syringe of Filgrastim HEXAL with or without a needle safety guard 2.
Siringa ġdida mimlija għal- lest b’ Filgrastim HEXAL bi jew mingħajr protezzjoni tas- sigurtà tal - labra 2.
Alcohol wipes or similar 3.
Biċċiet tal- alkoħol biex timsaħ jew xi ħaġa simili 3.
A puncture-proof container for disposing of used syringes safely if you use the Filgrastim HEXAL pre-filled syringe without a needle safety guard.
Kontenitur li ma jittaqqabx biex tarmi s- siringi użati b’ mod siġur jekk qed tuża s- siringa mimlija għal- lest ta ’ Filgrastim HEXAL mingħajr protezzjoni tas- sigurtà tal- labra.
57 What should I do before I give myself a subcutaneous injection of Filgrastim HEXAL?
X’ għandi nagħmel qabel ma nagħti lili nnifsi injezzjoni taħt il- ġilda b’ Filgrastim HEXAL?
Take your Filgrastim HEXAL pack out of the refrigerator.
Oħroġ il- pakkett ta ’ Filgrastim HEXAL mill- friġġ.
Do not shake the packing containing the pre-filled syringe.
Iċċaqlaqx il- pakkett li jkun fih is- siringa mimlija għal- lest.
Check that it is the correct strength you need for the dose that your doctor has prescribed.
Iċċekkja li jkun fih il- qawwa korretta li teħtieġ għad- doża li għaliha t- tabib tiegħek jkun tak riċetta.
Check the expiry date which is stated on the carton and syringe label (EXP).
Iċċekkja d- data ta ’ skadenza li tidher fuq il- kartuna u t- tikketta tas- siringa (EXP).
Do not use it if the date has passed the last day of the month shown.
Tużahiex jekk id- data tkun wara l- aħħar jum tax- xahar li jintwera.
Check the appearance of Filgrastim HEXAL.
Iċċekkja d- dehra ta ’ Filgrastim HEXAL.
It must be clear.
Irid ikun ċar.
If it is cloudy or there are particles in it, you must not use it.
Jekk ikun imċajpar jew jekk ikun fih il - partikuli, m’ għadekx tużah.
For a more comfortable injection, let the pre-filled syringe stand for 30 minutes to reach room temperature or hold the pre-filled syringe gently in your hand for a few minutes.
Għal injezzjoni iktar komda, ħalli s- siringa mimlija għal- lest toqgħod 30 minuta biex tilħaq it - temperatura tal- kamra jew żomm is- siringa mimlija għal- lest b’ mod ġentili f’ idejk għal ftit minuti.
Do not warm Filgrastim HEXAL in any other way (for example, do not warm it in a microwave or in hot water).
Issaħħanx Filgrastim HEXAL bi kwalunkwe mod ieħor (per eżempju, issaħħnux fil - microwave jew f’ ilma jaħraq).
Do not remove the plastic cover from the needle until you are ready to inject.
Tneħħix l- għatu tal- plastik minn fuq il- labra sakemm tkun lest/ a biex tinjetta.
Find a comfortable, well-lit place and put the syringe, the alcohol wipes and if necessary the puncture-proof container where you can reach them.
Sib post komdu u mdawwal tajjeb u poġġi s- siringa, it- tajjar bl- alkoħol u, jekk ikun hemm bżonn, il- kontenitur li ma jittaqqabx, fejn tkun tista ’ tilħaqhom.
How do I prepare the injection?
Kif għandi nipprepara l- injezzjoni?
Before you inject Filgrastim HEXAL you must do the following:
Qabel ma tinjetta Filgrastim HEXAL, għandek tagħmel dan li ġej:
Gently remove the plastic cover from the needle without twisting it.
Neħħi bil- mod l- għatu tal- plastik minn fuq il- labra mingħajr ma tilwih.
Hold the syringe with the needle pointing upwards to check if there are air bubbles in the syringe.
Żomm is- siringa bil- labra tipponta ’ l fuq u iċċekkja jekk ikunx hemm bżieżaq tal- arja fis - siringa.
If there are air bubbles in it expel all air from the syringe by cautiously pushing the plunger upwards (avoid expelling liquid from the syringe).
Jekk ikun fiha l- bżieżaq tal- arja, neħħi l- arja kollha minn ġos- siringa billi timbotta l - planġer ’ il fuq bl- attenzjoni (evita li xxerred il- likwidu mis- siringa).
The syringe has a scale on the syringe barrel.
Is- siringa għandha skala fuq il- bettija tas- siringa.
Push the plunger up to the number (ml) that matches the dose of Filgrastim HEXAL that your doctor prescribed.
Imbotta l- planġer san- numru (ml) li jaqbel mad- doża ta ’ Filgrastim HEXAL li għaliha jkun tak riċetta t- tabib tiegħek.
Check again to make sure the correct dose of Filgrastim HEXAL is in the syringe.
Iċċekkja mill- ġdid biex taċċerta ruħek li jkun hemm id- doża korretta fis- siringa ta ’ Filgrastim HEXAL.
You can now use the pre-filled syringe.
Issa tista ’ tuża s- siringa mimlija għal- lest.
Where should I give my injection?
Fejn għandi ninjetta lili nnifsi?
The most suitable places to inject yourself are:
L- aktar postijiet adattati biex tinjetta lilek innifsek huma:
- The top of your thighs; and
- In- naħa ta ’ fuq tal- koxox; u
- The abdomen, except for the area around the navel.
- Iż- żaqq, ħlief għaż- żona madwar iż- żokra.
Change the place that you inject each time so you don’ t become sore in one area.
58 Ibdel il- post li fih tinjetta kull darba biex ma jkollokx uġigħ f’ żona waħda.
If someone is injecting for you, they can also use the back of your arms.
Jekk xi ħaddieħor ikun qed jagħtik l- injezzjoni, in- naħa ta ’ wara ta ’ dirgħajk tista ’ tintuża wkoll.
How do I give my injection?
Kif ninjetta lili nnifsi?
Disinfect your skin by using an alcohol wipe and pinch the skin between your thumb and forefinger, without squeezing it.
Iddiżinfetta l- ġilda tiegħek billi tuża biċċa tajjara bl- alkoħol, u oqros il- ġilda bejn is- saba ’ l- kbir u s- saba ’ l- werrej, mingħajr ma tagħfasha.
Insert the needle under the skin at an angle of approximately 45° as shown by your nurse or doctor.
Daħħal il- labra taħt il- ġilda f’ angolu ta ’ madwar 45°, kif juruk it- tabib jew l- infermiera tiegħek.
If you see blood in the syringe, remove the needle and put it in another place.
Jekk tara d- demm fis- siringa, neħħi l- labra u daħħalha f’ post ieħor.
Pre-filled syringe without needle safety guard
Siringa mimlija għal- lest mingħajr protezzjoni tas- sigurtà tal- labra
Always keeping your skin pinched, depress the plunger slowly and evenly.
Filwaqt li żżomm dejjem il- ġilda tiegħek maqrusa, agħfas il- planġer bil- mod u b’ mod konsistenti.
After injecting the liquid, remove the needle and let go of your skin.
Wara li tinjetta l- likwidu, neħħi l- labra u l- erħi l- ġilda.
Put the used syringe in the disposal container.
Poġġi s- siringa użata fir- reċipjent għar- rimi.
Use each syringe only for one injection.
Uża kull siringa għal injezzjoni waħda biss.
Pre-filled syringe with needle safety guard
Siringa mimlija għal- lest bi protezzjoni tas- sigurtà tal- labra
Always keeping your skin pinched, depress the plunger slowly and evenly until the entire dose has been given and the plunger cannot be depressed any further.
Filwaqt li żżomm il- ġilda tiegħek maqrusa, agħfas il- planġer bil- mod u b’ mod konsistenti sakemm id- doża kollha tkun ingħatat u l- planġer ma jkunx jista ’ jingħafas iktar.
Do not release the pressure on the plunger!
Ibqa agħfas il- planġer!
After injecting the liquid, remove the needle while maintaining pressure on the plunger and then let go of your skin.
Wara li tinjetta l- likwidu, neħħi l- labra filwaqt li tkompli tagħfas il- planġer, u mbagħad erħi l- ġilda tiegħek.
Let go of the plunger.
Erħi l- planġer.
The needle safety guard will rapidly move to cover the needle.
Il- protezzjoni tas- sigurtà tal- labra ser tiċċaqlaq malajr biex tgħatti l- labra.
Remember
Ftakar
If you have any problems, please do not be afraid to ask your doctor or nurse for help and advice.
Jekk ikollok xi problemi, jekk jogħġbok tibżax titlob l- għajnuna jew parir lit- tabib jew lill- infermiera tiegħek.
Disposal of used syringes
Kif tarmi s- siringi użati
The used syringes should be disposed of in accordance with local requirements.
Is- siringi użati għandhom jintremew kif jitolbu l- liġijiet lokali.
- Do not put the cover back on used syringes.
- Tpoġġix l- għatu lura fuq fuq siringi użati.
- Put used syringes into the puncture-proof disposal container and keep it out of the reach and
- Poġġi s- siringi użati kontenitur għar- rimi li ma jittaqqabx u żommu fejn ma jintlaħaqx u fejn ma
sight of children.
jidhirx mit- tfal.
- Dispose of the full container as instructed by your doctor, nurse or pharmacist.
- Armi l- kontenitur mimli skont kif jgħidulek it- tabib, l- infermiera jew l- ispiżjar tiegħek.
- NEVER put used syringes into your normal household waste bin.
- QATT m’ għandek tarmi siringi użati ġol- kontenitur tal- iskart normali tad- dar.
- The needle safety guard prevents needle stick injuries after use, so no special disposal
- Il- protezzjoni tas- sigurtà tal- labra ma tħallix li jseħħu korrimenti minħabba tingiż bil- labra wara
precautions are required.
l- użu, u għalhekk, l- ebda prekawzjonijiet speċjali għar- rimi m’ huma meħtieġa.
Dispose of the syringe as instructed by your doctor, nurse or pharmacist.
Armi s- siringa skont kif jgħidulek it- tabib, l- infermiera jew l- ispiżjar tiegħek.
------------------------------------------------------------------------------------------------------------------------- The following information is intended for medical or healthcare professionals only:
------------------------------------------------------------------------------------------------------------------------- It- tagħrif li jmiss qed jingħata biss għall- professjonisti fil- qasam mediku:
The solution should be visually inspected prior to use.
59 Is- soluzzjoni għandha tiġi eżaminata viżwalment qabel l- użu.
59 When diluted in glucose 50 mg/ ml (5%) solution, filgrastim is compatible with glass and a variety of plastics including polyvinylchloride, polyolefin (a copolymer of polypropylene and polyethylene) and polypropylene.
Meta jkun dilwiti f’ soluzzjoni ta ’ 50 mg/ ml (5%) ta ’ glucose, filgrastim hu kompatibbli mal- ħġieġ u ma ’ varjetà ta ’ plastiks li jinkludu polyvinylchloride, polyolefin (copolymer ta ’ polypropylene u polyethylene) u polypropylene.
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, iż- żmien tal- ħażna waqt l- użu u l - kundizzjonijiet ta ’ qabel l- użu huma r- responsabbiltà tal- utent, u normalment ma jkunux itwal minn 24 siegħa f’ temperatura ta ’ 2°C sa 8°C, ħlief jekk id- dilwizzjoni ma tkunx saret f’ kundizzjonijiet asettiċi kkontrollati u vverifikati.
What is Filgrastim ratiopharm?
X’ inhu Filgrastim ratiopharm?
Filgrastim ratiopharm is a solution for injection or for infusion (drip into a vein).
Filgrastim ratiopharm hu konċentrat li jiġi mdewweb biex jingħata b’ infużjoni (drip fil- vina).
It contains the active substance filgrastim.
Fih is - sustanza attiva filgrastim.
Filgrastim ratiopharm is a ‘ biosimilar’ medicine.
Filgrastim ratiopharm hija mediċina ‘ bijosimili ’.
This means that Filgrastim ratiopharm 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 ratiopharm 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 ratiopharm is Neupogen.
Il- mediċina ta ’ referenza għal Filgrastim ratiopharm hija Neupogen.
What is Filgrastim ratiopharm used for?
Għal xiex jintuża Filgrastim ratiopharm?
Filgrastim ratiopharm can also be used in patients who are about to donate blood stem cells for transplant, to help release these cells from the bone marrow.
Filgrastim ratiopharm huwa wżat 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 ma ’ l- 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 ta ’ l- immunodefiċjenza fi stat avvanzat [HIV]). Filgrastim ratiopharm 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 ratiopharm used?
Kif jintuża Filgrastim ratiopharm?
Filgrastim ratiopharm is given by injection under the skin or infusion into a vein.
Filgrastim ratiopharm 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 ta ’ l- użu, il- massa korporja tal- pazjent u r - rispons għat- trattament.
Filgrastim ratiopharm 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 ratiopharm 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 ratiopharm work?
Kif jaħdem Filgrastim ratiopharm?
The active substance in Filgrastim ratiopharm, filgrastim, is very similar to a human protein called granulocyte colony stimulating factor (G-CSF).
Is- sustanza attiva f’ Filgrastim ratiopharm, filgrastim hija simili ħafna għal proteina umana msejjħa stimulazzjoni tal- kolownja granuloċijto (G- CSF).
How has Filgrastim ratiopharm been studied?
Kif ġie studjat Filgrastim ratiopharm?
Filgrastim ratiopharm was studied to show that it is comparable to the reference medicine, Neupogen.
Filgrastim ratiopharm ġie studjat biex jiġi muri li huwa komparabbli mal- mediċina ta ’ referenza, Neupogen.
Filgrastim ratiopharm was compared to Neupogen and to placebo (a dummy treatment) in one main study involving 348 patients with breast cancer.
Filgrastim ratiopharm ġie kumparat ma ’ Neupogen u ma ’ placebo (trattament fint) fi studju prinċipali li kien jinvolvi 348 pazjent bil- kanċer tas- sider.
The study looked at the duration of severe neutropenia during the patients’ first cycle of cytotoxic chemotherapy.
L- istudju ħares lejn żmien ta ’ newtropenija severa matul l- ewwel ċiklu ta ’ kemoterapija ċitotossika tal- pazjenti.
To study the safety of Filgrastim ratiopharm, two further studies were carried out in patients with lung cancer and with non-Hodgkin’ s lymphoma.
Sabiex tiġi studjata s- sigurtà ta ’ Filgrastim ratiopharm, saru żewġ studju oħrajn fuq pazjenti bil- kanċer tal- pulmun u limfoma non- Hodgkin.
What benefit has Filgrastim ratiopharm shown during the studies?
X' benefiċċju wera Filgrastim ratiopharm matul l- istudji mwettqa?
Treatment with Filgrastim ratiopharm and Neupogen brought about similar reductions in duration of severe neutropenia.
Trattament bir- Filgrastim ratiopharm u n- Neupogen ġab tnaqqis simili fiż- żmien ta ’ newtropenija severa.
During the first 21-day chemotherapy cycle, patients treated with either Filgrastim ratiopharm or Neupogen had severe neutropenia for an average of 1.1 days, compared with 3.8 days in those receiving placebo.
Matul l- ewwel 21 jum ta ’ ċiklu kemoterapewtiku, pazjenti trattati b’ kemm Filgrastim ratiopharm jew Neupogen kellhom newtropenija severa għal medja ta ’ 1. 1 jum, kumparat ma ’ 3. 8 jum f’ dak li jirċievu placebo.
Therefore, the effectiveness of Filgrastim ratiopharm was shown to be equivalent to that of Neupogen.
Għalhekk, l- effikaċja ta ’ Filgrastim ratiopharm ġiet murija bħala ekwivalenti għal dik ta ’ Neupogen.
What is the risk associated with Filgrastim ratiopharm?
X’ inhu r- riskju assoċjat ma ’ Filgrastim ratiopharm?
The most common side effect with Filgrastim ratiopharm (seen in more than 1 patient in 10) is musculoskeletal pain (pain in the muscles and bones).
X' inhu r- riskju assoċjat ma 'Filgrastim ratiopharm (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 ratiopharm is being used for.
Effetti sekondarji oħrajn jistgħu jidhru f’ aktar minn pazjent minn għaxra skond il- kondizzjoni li Filgrastim ratiopharm jkun użat għaliha.
For the full list of all side effects reported with Filgrastim ratiopharm, see the Package Leaflet.
Għal- lista sħiħa ta ’ l- effetti sekondarji kollha rrappurtata b’ Filgrastim ratiopharm, ara l - Fuljett ta ’ Tagħrif.
Filgrastim ratiopharm should not be used in people who may be hypersensitive (allergic) to filgrastim or any of the other ingredients.
Filgrastim ratiopharm m’ għandux jintuża minn persuni ipersensittivi (allerġiċi) għal filgrastim jew għal xi ingredjenti oħra tiegħu.
Why has Filgrastim ratiopharm been approved?
Għaliex ġie approvat Filgrastim ratiopharm?
The Committee for Medicinal Products for Human Use (CHMP) decided that, in accordance with EU requirements, Filgrastim ratiopharm 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 ta ’ l- Unjoni Ewropea, Filgrastim ratiopharm wera li għandu kwalità, sigurtà u effikaċja komparabbli ma ’ dawk ta ’ Neupogen.
The Committee recommended that Filgrastim ratiopharm be given marketing authorisation.
Il- Kumitat irrakkomanda li Filgrastim ratiopharm jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Filgrastim ratiopharm:
Tagħrif ieħor dwar Filgrastim ratiopharm:
The European Commission granted a marketing authorisation valid throughout the EU for Filgrastim ratiopharm to ratiopharm GmbH on 15 September 2008.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida fl- Unjoni Ewropea kollha għal Filgrastim ratiopharm lil Addmedica fil- 15 ta 'Settembru 2008.
The full EPAR for Filgrastim ratiopharm can be found here.
L- EPAR sħiħ għal Filgrastim ratiopharm jista ’ jinstab hawnhekk.
5 pre-filled syringes
5 siringi mimlijin għal- lest
2 x 5 pre-filled syringes
2x5 siringi mimlijin għal- lest
10 pre-filled syringes
10 siringi mimlijin għal- lest
Filgrastim ratiopharm 30 MIU/ 0.5 ml solution for injection or infusion
Filgrastim ratiopharm 30 MIU/ 0. 5ml soluzzjoni għall- injezzjoni jew infużjoni
Filgrastim ratiopharm is indicated for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes) and for the 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.
Filgrastim ratiopharm huwa indikat għat- tnaqqis fid- dewmien ta ’ newtropenja u fl- inċidenza ta ’ newtropenja bid- deni f’ pazjenti kkurati b’ kimoterapija ċitotossika stabbilita kontra malinni (bl - eċċezzjoni ta ’ lewkimja majelojde kronika u sindromi majelodisplastiċi) u għat- tnaqqis fid- dewmien ta ’ newtropenja f’ pazjenti, taħt kura majeloablativa u segwita bit- trapjant tal- mudullun, li huma meqjusa li għandhom riskju għola ta ’ newtropenja qawwija u mdewma.
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 fit- tfal li qed jirċievu kimoterapija ċitotossika.
Filgrastim ratiopharm is indicated for the mobilisation of peripheral blood progenitor cells (PBPC).
Filgrastim ratiopharm huwa indikat għall- mobilizzazzjoni taċ- ċelluli proġenitriċi tad- demm periferali( PBPC).
In patients, children or adults, with severe congenital, cyclic, or idiopathic neutropenia with an absolute neutrophil count (ANC) of 0.5 x 109/ l, and a history of severe or recurrent infections, long term administration of Filgrastim ratiopharm is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events.
F’ pazjenti, tfal jew adulti, li għandhom newtropenja severa, konġenita, ċiklika, jew idjopatika bl- Għadd Assolut ta ’ Newtrofili (ANC) ta ’ 0. 5 x 109/ l, u storja ta ’ infezzjonijiet qawwija jew li jirkadu, it- terapija fit- tul b’ Filgrastim ratiopharm huwa indikat biex jiżdied l- għadd ta ’ newtrofili u sabiex l- inċidenza u t- tul ta ’ ġrajjiet avversi relatati ma ’ infezzjonijiet jonqsu.
Filgrastim ratiopharm is indicated for the treatment of persistent neutropenia (ANC less than or equal to 1.0 x 109/ l) in patients with advanced HIV infection, in order to reduce the risk of bacterial infections when other options to manage neutropenia are inappropriate.
Filgrastim ratiopharm huwa indikat għal kura ta ’ newtropenja persistenti (ANC ta ’ 1. 0 x 109/ l jew inqas) f’ pazjenti b’ infezzjoni avvanzata ta ’ l- HIV, sabiex jitnaqqas ir- riskju ta ’ infezzjonijiet batteriċi, dan meta għażliet oħra għall- immaniġġjar ta ’ newtropenja ma jkunux addattati.
The mobilisation and apheresis procedures should be performed in
Il- mobilizzazzjoni u l- proċeduri afereżi għandhom isiru flimkien 2 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.
Neutrophil count > 1.0 x 109/ l for 3 consecutive days 9
Għadd ta ’ Newtrofili 9
Filgrastim dose adjustment Reduce to 0.5 MIU (5 µg)/ kg/ day
Bdil fid- doża ta ’ Filgrastim
Then, if ANC remains > 1.0 x 10 / l for 3 more consecutive days
> 1. 0 x 10 / l għal 3 ijiem konsekuttivi
Discontinue filgrastim
Naqqas għal 0. 5 MIU (5 µg) / kg/ jum
Leukapheresis should be performed during the period when the ANC rises from< 0.5 x 109/l to > 5.0 x 109/l.
Lewkafereżi jrid isir fil- perijodu meta l- ANC jitla ’ minn < 0. 5 x 109/ l sa > 5. 0 x 109/ l.
Initial dose adjustment to alternate day dosing with 30 MIU (300 μ g)/ day by subcutaneous injection is recommended.
Huwa rakkomandat illi id- dożaġġ tal- bidu ta ’ kuljum tinbidel għal waħda ta ’ 30 MIU (300 μg) / jum b ’ injezzjoni taħt il- ġilda ġurnata iva u oħra le.
Further dose adjustment may be necessary, as determined by the patient's ANC, to maintain the neutrophil count at > 2.0 x 109/ l.
Jista ’
4 > 2.0 x 109/ l, with the median dose frequency being 3 days per week.
4 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.
The safety and efficacy of filgrastim have not been assessed in normal donors< 16 years or > 60 years.
Is- sigurta ’ u l- effikaċja ta ’ filgrastim ma ġewx investigati f’ donaturi b’ saħħithom < 16- il sena jew > 60 sena.
Filgrastim ratiopharm contains sorbitol.
Filgrastim ratiopharm fih sorbitol.
Patients with rare hereditary problems of fructose intolerance should not use this medicinal product.
Pazjenti li għandhom problemi ereditarji rari ta ’ intolleranza għall - fructose m’ għandhomx jieħdu din il- mediċina.
During clinical studies 541 cancer patients and 188 healthy volunteers were exposed to Filgrastim ratiopharm.
Fi studji kliniċi, 541 pazjenti b’ kanċer u 188 volontiera f’ saħħithom ġew esposti għal Filgrastim ratiopharm.
The safety profile of Filgrastim ratiopharm observed in these clinical studies was consistent with that reported with the reference product used in these studies.
Il- profil ta ’ sigurta ’ ta ’ Filgrastim ratiopharm li ġie osservat f’ dawn l- istudji kliniċi kien konsistenti ma dak tal- prodott ta ’ referenza li ntuża f’ dawn l- istudji.
Filgrastim ratiopharm containing r-metHuG-CSF (filgrastim) causes marked increases in peripheral blood neutrophil counts within 24 hours, with minor increases in monocytes.
Filgrastim ratiopharm, 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.
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.
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.
The efficacy and safety of Filgrastim ratiopharm has been assessed in randomised, controlled phase III studies in breast cancer, lung cancer and Non-Hodgkin-Lymphoma.
L- effikaċja u s- sigurta ’ ta ’ Filgrastim ratiopharm 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 Filgrastim ratiopharm and the reference product with regard to duration of severe neutropenia and incidence of febrile neutropenia.
Ma kienx hemm differenzi rilevanti bejn Filgrastim ratiopharm 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 Filgrastim ratiopharm 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’ Filgrastim ratiopharm kien komparabbli ma ’ dak tal- prodott ta ’ referenza kemm wara amministrazzjoni taħt il- ġilda kif ukoll ġol- vina.
In cancer patients, the pharmacokinetic profile of Filgrastim ratiopharm and the reference product was comparable after single and repeated subcutaneous administration.
F’ pazjenti b’ kanċer, il- profil farmacokinetiku ta ’ Filgrastim ratiopharm u dak tal- prodott ta ’ referenza kienu komparabbli wara amministrazzjoni taħt il- ġilda ta ’ doża waħda jew dożi ripetuti.
15 Filgrastim ratiopharm should not be diluted with sodium chloride solution.
Filgrastim ratiopharm m’ għandux jiġi dilwit ma ’ soluzzjoni ta ’ sodium chloride.
If required, Filgrastim ratiopharm may be diluted in glucose 50 mg/ ml (5%) solution for infusion.
Jekk ikun hemm il- ħtieġa, Filgrastim ratiopharm jista ’ jiġi dilwit f’ soluzzjoni għal infużjoni ta ’ glucose 50 mg/ ml (5%).
When diluted in glucose 50 mg/ ml (5%) solution for infusion, Filgrastim ratiopharm 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%), Filgrastim ratiopharm huwa kompatibbli mal- ħġieġ u varji tipi ta ’ plastik, fosthom il- PVC, polyolefin (co- polymer ta ’ polypropylene u polyethylene) u polypropylene.
Filgrastim ratiopharm does not contain any preservative.
Filgrastim ratiopharm ma fih l- ebda preservattiv.
In view of the possible risk of microbial contamination, Filgrastim ratiopharm syringes are for single use only.
Minħabba r- riskju potenzjali ta ’ kontaminazzjoni b’ mikrobi, is- siringi ta ’ Filgrastim ratiopharm iridu jintużaw darba biss.
16 Accidental exposure to freezing temperatures does not adversely affect the stability of Filgrastim ratiopharm.
L- esposizzjoni bi żball għal temperatura ta ’ friża ma jeffettwax ħażin l- istabilita` ta ’ Filgrastim ratiopharm.
ratiopharm GmbH Graf-Arco-Straße 3 D-89079 Ulm Germany info@ratiopharm. de
ratiopharm GmbH Graf- Arco- Straße 3 D- 89079 Ulm Il- Ġermanja info@ ratiopharm. de
Filgrastim ratiopharm 48 MIU/ 0.8 ml solution for injection or infusion
Filgrastim ratiopharm 48 MIU/ 0. 8ml soluzzjoni għall- injezzjoni jew infużjoni
The mobilisation and apheresis procedures should be performed in
Il- kura b’ filgrastim għandha tingħata biss b’ kollaborazzjoni ma ’ ċentru ta ’ onkoloġija b’ esperjenza fil- kura bil- fattur uman li jistimola l- kolonji ta ’ granuloċiti (G- CSF) u ematoloġija u fejn jinstabu l- meżżi dijanjostiċi kollha meħtieġa.
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.
Il- mobilizzazzjoni u l- proċeduri afereżi għandhom isiru flimkien 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.
20 > 2.0 x 109/ l, with the median dose frequency being 3 days per week.
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.
31 Filgrastim ratiopharm should not be diluted with sodium chloride solution.
Filgrastim ratiopharm m’ għandux jiġi dilwit ma ’ soluzzjoni ta ’ sodium chloride.
32 Accidental exposure to freezing temperatures does not adversely affect the stability of Filgrastim ratiopharm.
L- esposizzjoni bi żball għal temperatura ta ’ friża ma jeffettwax ħażin l- istabilita` ta ’ Filgrastim ratiopharm.
Pharmacovigilance system The MAH must ensure that the system of pharmacovigilance, as described in version 2.1 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.
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
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 • At the request of the EMEA
35 ANNESS III
Filgrastim ratiopharm 30 MIU/ 0.5 ml
Filgrastim ratiopharm 30 MIU/ 0. 5ml
Filgrastim ratiopharm 48 MIU/ 0.8 ml
Filgrastim ratiopharm 48 MIU/ 0. 8ml
Filgrastim ratiopharm 30 MIU/ 0.5 ml
Filgrastim ratiopharm 30 MIU/ 0. 5 ml
Filgrastim ratiopharm 48 MIU/ 0.8 ml
Filgrastim ratiopharm 48 MIU/ 0. 8 ml
Filgrastim ratiopharm 30 MIU/ 0.5 ml solution for injection or infusion Filgrastim ratiopharm 48 MIU/ 0.8 ml solution for injection or infusion
Filgrastim ratiopharm 30 MIU/ 0. 5ml soluzzjoni għall- injezzjoni jew infużjoni Filgrastim ratiopharm 48 MIU/ 0. 8ml soluzzjoni għall- injezzjoni jew infużjoni
What Filgrastim ratiopharm is and what it is used for 2.
X’ inhu Filgrastim ratiopharm u għalxiex jintuża 2.
Before you use Filgrastim ratiopharm 3.
Qabel ma tuża Filgrastim ratiopharm 3.
How to use Filgrastim ratiopharm 4.
Kif għandek tuża Filgrastim ratiopharm 4.
How to store Filgrastim ratiopharm 6.
Kif taħżen Filgrastim ratiopharm 6.
WHAT Filgrastim ratiopharm IS AND WHAT IT IS USED FOR
X’ INHU Filgrastim ratiopharm U GĦALXIEX JINTUŻA
What Filgrastim ratiopharm is Filgrastim ratiopharm contains the active substance filgrastim.
X’ inhu Filgrastim ratiopharm Filgrastim ratiopharm fih is- sostanza attiva filgrastim.
What Filgrastim ratiopharm is used for Your doctor has prescribed Filgrastim ratiopharm for you to help your body make more white blood cells.
Għalxiex jintuża Filgrastim ratiopharm It- tabib tiegħek tak Filgrastim ratiopharm biex jgħin il- ġismek jipproduċi aktar ċelluli bojod.
Your doctor will tell you why you are being treated with Filgrastim ratiopharm.
It- tabib tiegħek ser jgħidlek il- għaliex qed tingħata kura b’ Filgrastim ratiopharm.
Filgrastim ratiopharm is useful in several different conditions which are:
Filgrastim ratiopharm huwa ta ’ benefiċju f’ ħafna kundizzjonijiet differenti li huma:
BEFORE YOU USE Filgrastim ratiopharm
QABEL MA TUŻA Filgrastim ratiopharm
Do not use Filgrastim ratiopharm
Tużax Filgrastim ratiopharm
- if you are allergic (hypersensitive) to filgrastim or to any of the other ingredients of Filgrastim
- jekk inti allerġiku/ a (tbagħti minn sensittività eċċessiva) għal filgrastim jew sustanzi oħra ta ’
Take special care with Filgrastim ratiopharm
Oqgħod attent ħafna b’ Filgrastim ratiopharm
POSSIBLE SIDE EFFECTS”).
pulmonarju (ara sezzjoni 4, “ Effetti sekondarji li jista ’ jkollu ”).
POSSIBLE SIDE EFFECTS”).
jista ’ jkun konsegwenza ta ’ disturb fil- milza tiegħek (ara sezzjoni 4, “ Effetti sekondarji li jista ’ jkollu ”)
You will need to have regular blood tests whilst being treated with Filgrastim ratiopharm to count the number of neutrophils and other white blood cells in your blood.
Ikollok bżonn tagħmel analiżi tad- demm regolari waqt il- kura b’ Filgrastim ratiopharm biex isir magħruf l- għadd ta ’ newtrofili u l- għadd ta ’ celluli bojod oħra ġo demmek.
This will tell your doctor how well the treatment is working and will also indicate if treatment needs to be continued.
Ir- riżultati minn dawn l - analiżi jgħinu lit- tabib tiegħek jiddetermina kemm qed tkun effettiva l- kura kif ukol jindikaw jekk il - kura għandiex titkompla jew le.
Filgrastim ratiopharm has not been tested in pregnant women.
Filgrastim ratiopharm ma ġiex ittestjat f’ nisa tqal.
It is important to tell your doctor if you are pregnant, think you may be pregnant or plan to get pregnant, as the doctor may decide that you should not use this medicine.
Huwa importanti li tgħid lit- tabib tiegħek jekk inti tqila, taħseb li tista ’ tkun tqila, jew qed tippjana li toħroġ tqila, għax it- tabib jista ’ jiddeċidi li m’ għandekx tuża dil- mediċina.
Important information about some of the ingredients of Filgrastim ratiopharm This medicine contains sorbitol (a type of sugar).
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Filgrastim ratiopharm Din il- mediċina fiha sorbitol (tip ta ’ zokkor).
HOW TO USE Filgrastim ratiopharm
KIF GĦANDEK TUŻA Filgrastim ratiopharm
Always use Filgrastim ratiopharm exactly as your doctor has told you.
Dejjem għandek tuża Filgrastim ratiopharm skond il- parir tat- tabib.
The amount of Filgrastim ratiopharm you need will depend on the condition you are taking Filgrastim ratiopharm for and on your bodyweight.
Id- doża li ssoltu tingħata hija … L- ammont ta ’ Filgrastim ratiopharm li għandek bżonn ser jiddependi fuq il- kundizzjoni tiegħek, ir- raġuni għaliex trid tieħu Filgrastim ratiopharm, u fuq il- piz ta’ ġismek.
Your doctor will tell you when to stop using Filgrastim ratiopharm.
It- tabib tiegħek jgħidlek meta għandek tieqaf tieħu Filgrastim ratiopharm.
It is quite normal to have a number of courses of Filgrastim ratiopharm treatment.
Hija ħaġa normali li jkollok bżonn numru ta ’ korsijiet ta ’ kura b’ Filgrastim ratiopharm
Filgrastim ratiopharm and chemotherapy The usual dose is 0.5 million international units (MIU) per kilogram of bodyweight each day.
Filgrastim ratiopharm u kimoterapija Id- doża li tintuża normali hija 0. 5 miljun international units (MIU) għal kull kilogramm ta ’ piż tal - ġisem, kuljum.
Filgrastim ratiopharm and bone marrow transplantation The usual starting dose is 1 million international units (MIU) per kilogram of bodyweight each day.
Filgrastim ratiopharm u trapjant tal- mudullun Id- doża tal- bidu li tintuża normali hija 1 miljun international units (MIU) għal kull kilogramm ta ’ piż tal- ġisem, kuljum.
You will normally receive your first dose of Filgrastim ratiopharm at least 24 hours after your chemotherapy but within 24 hours of receiving your bone marrow transfusion.
Normalment, tirċievi l- ewwel doża tiegħek ta ’ Filgrastim ratiopharm mill - inqas 24 siegħa wara l- kimoterapija imma qabel 24 hours li tirċievi t- trasfużjoni tal- mudullun.
Filgrastim ratiopharm and severe chronic neutropenia The usual starting dose is between 0.5 million and 1.2 million international units (MIU) per kilogram bodyweight each day in a single or divided dose.
54 Id- doża tal- bidu li tintuża normali hija bejn 0. 5 miljun u 1. 2 miljun international units (MIU) għal kull kilogramm ta ’ piż tal- ġisem, kuljum, mogħtija bħala doża waħda jew ħafna.
Long-term treatment with Filgrastim ratiopharm is required for neutropenia.
Għat- trattament ta ’ newtropenja, ikun hemm bżonn ta ’ kura b’ Filgrastim ratiopharm fit - tul.
54 Filgrastim ratiopharm and neutropenia in patients with HIV infection The usual starting dose is between 0.1 and 0.4 million international units (MIU) per kilogram bodyweight each day.
Filgrastim ratiopharm u newtropenja f’ pazjenti bl- infezzjoni ta ’ HIV Id- doża tal- bidu li tintuża normali hija bejn 0. 1 u 0. 4 miljun international units (MIU) għal kull kilogramm ta ’ piż tal- ġisem, kuljum.