qanastek/EMEA-V3 huggingface dataset:
It is important that you contact your doctor immediately if you experience pain in the upper left side of the abdomen or left shoulder pain since this may relate to a problem with your spleen.
Huwa importanti li tgħarraf lit- tabib tiegħek immedjatament jekk jkollok uġigħ fin- naħa ta 'fuq fix - xellug ta' l- addome jew jkollok uġigħ fl- ispalla xellugija, peress li dan jista 'jkun relatat ma' problema fil- milza tiegħek.
Rare (likely to occur in fewer than 1 in 1000 patients) cases of breathing problems have been reported after taking G-CSFs.
Każijiet rari (li hemm ċans li jseħħu f ’ anqas minn pazjent 1 f ’ kull 1000 pazjent) ta 'problemi biex tieħu n- nifs ġew irrappurtati wara li ttieħdu fatturi li jistimolaw l- kolonji ta ’ granuloċiti (G- CSFs).
If you have a cough, fever and difficulty breathing please tell your doctor.
Jekk taqbdek is- sogħla, jitlagħlek id- deni jew ikollok problemi biex tieħu n- nifs għarraf lit- tabib tiegħek.
Some changes may occur in your blood, but these will be detected by routine blood tests.
Jista 'jkun hemm ftit tibdil fid- demm tiegħek, imma dan it- tibdil se joħrog fir- riżultat tat- testijiet tad - demm li jsiru b' rutina.
Your platelet count may become low which might result in bruising.
L- għadd ta 'plejtlits jista' jitbaxxa u dan jista 'jirriżulta fi tbenġil.
Your white blood cell count may become high for a short period of time.
L- għadd ta 'ċelluli bojod jista' jogħla għal- tul ta 'żmien qasir.
Sweet’ s syndrome (plum-coloured, raised, painful lesions on the limbs and sometimes the face and neck with fever) has occurred rarely (likely to occur in fewer than 1 in 1,000 patients) but other factors may play a role.
Seħħ rarament (li hemm ċans li jseħħu f ’ anqas minn pazjent 1 f ’ kull 1, 000 pazjent) s- sindromu ta 'Sweet (leżjonijiet ibbuzzati, li jweġgħu, kulur aħmar skur fil- vjola fuq ir- riġlejn u xi drabi fil- wiċċ u fl- ghonq bid- deni) imma fatturi oħra jistgħu jkollhom sehem f' dan.
Very rarely (likely to occur in fewer than 1 in 10,000 patients) cutaneous vasculitis (inflammation of the blood vessels in the skin) has occurred in patients receiving Neulasta.
Rari ħafna (hemm ċans li jseħħ f ’ anqas minn pazjent 1 f ’ kull 10, 000 pazjent) kien hemm infjammazzjoni fil- vini/ arterji taħt il- ġilda f' pazjenti jieħdu Neulasta.
HOW TO STORE NEULASTA
KIF TAĦŻEN NEULASTA
Do not use Neulasta after the expiry date which is stated on the box and on the syringe label (EXP).
35 Tużax Neulasta wara d- data ta ’ skadenza li tidher fuq il- kaxxa u fuq it- tikketta tas- siringa (JIS).
You may take Neulasta out of the refrigerator and keep it at room temperature (not above 30°C) for no longer than 3 days.
Tista ’ toħroġ Neulasta mill- friġġ u żżommu f’ temperatura ambjentali (mhux aktar minn 30°C) għal mhux aktar minn 3 ijiem.
Once a syringe has been removed from the refrigerator and has reached room temperature (not above 30°C) it must either be used within 3 days or disposed of.
La darba siringa tkun tneħħiet mill- friġġ u tkun laħqet temperatura ambjentali (mhux aktar minn 30°C) għandha tintuża fi żmien 3 ijiem jew tintrema.
35 Do not freeze.
Tagħmlux fil- friża.
Neulasta may be used if it is accidentally frozen for a single period of less than 24 hours.
Neulasta jista ’ jintuża jekk jiġi ffriżat bi żball għal perjodu wieħed ta ’ inqas minn 24 siegħa.
Keep the container in the outer carton in order to protect from light.
Żomm il- kontenitur fil- pakkett ta ’ barra biex tilqa ’ mid- dawl.
Do not use Neulasta if you notice it is cloudy or there are particles in it.
Tużax Neulasta jekk tinnota li huwa imdardar jew jekk tara xi frak ġo fih.
What Neulasta contains
X’ fih Neulasta
Neulasta contains the active substance pegfilgrastim.
Neulasta fih is- sustanza attiva pegfilgrastim.
Pegfilgrastim is a protein produced by biotechnology in bacteria called E. coli.
Pegfilgrastim huwa proteina magħmula mill - bijoteknoloġija f’ batterji li jissejħu E.
It belongs to a group of proteins called cytokines, and is very similar to a natural protein (granulocyte-colony stimulating factor) produced by your own body.
Huwa parti minn grupp ta ’ proteini msejħa ċitokini, u jixbaħ ħafna lill- proteina naturali (fattur li jistimola l- kolonji ta ’ granuloċiti) li hija prodotta mill- ġisem tiegħek.
The active substance is pegfilgrastim.
Is- sustanza attiva hi pegfilgrastim.
Each pre-filled syringe contains 6 mg of pegfilgrastim in 0.6 ml of solution.
Kull siringa mimlija għal- lest fiha 6 mg ta ’ pegfilgrastim f ’ soluzzjoni ta ’ 0. 6 ml.
The other ingredients are sodium acetate, sorbitol (E420), polysorbate 20 and water for injections.
Is- sustanzi l- oħra huma sodium acetate, sorbitol (E420), polysorbate 20 u ilma għall- injezzjoni.
What Neulasta looks like and contents of the pack
Id- Dehra tal- prodott u l- kontenuti tal- pakkett
Neulasta is a solution for injection in a pre-filled syringe (6 mg/ 0.6 ml).
Neulasta huwa soluzzjoni għall- injezzjoni ġo siringa mimlija għal- lest (6 mg / 0. 6ml).
Each pack contains 1 pre-filled syringe.
Kull pakkett fiħ siringa waħda mimlija għal- lest.
The syringes are provided either with or without a blister wrapping.
Is- siringi jinstabu ġo folja jew mingħajr folja.
It is a clear, colourless liquid.
Neulasta huwa likwidu ċar mingħajr kulur.
Marketing Authorisation Holder and Manufacturer:
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- suq u l- Manifattur:
If you want more information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Għal kull tagħrif dwar din il- mediċina, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq.
Amgen Kft.
Magyarország България Amgen Kft.
Tel.: +36 1 35 44 700
Б. Браун Медикал ООД Tel.: +36 1 35 44 700 Тел: + 359( 2) 8080711
37 This leaflet was last approved in.
Dan il- fuljett kien approvat l- aħħar f ’.
Instructions for injecting with the Neulasta pre-filled syringe
Tagħrif dwar kif tinjetta lilek innifsek b' siringa mimlija għal- lest b' Neulasta
This section contains information on how to give yourself an injection of Neulasta.
Din il- parti tal- fuljett tinkludi tagħrif dwar kif tagħti injezzjoni ta ’ Neulasta lilek innifsek.
It is important that you do not try to give yourself the injection unless you have received training from your doctor, nurse, or pharmacist.
Importanti li ma tippruvax tagħti l- injezzjoni lilek innifsek jekk ma tkunx irċevejtx taħriġ speċjali mit- tabib, mill- infermiera jew mill- ispiżjar tiegħek.
How do you, or the person injecting you, use Neulasta pre-filled syringe?
Kif inti, jew il- persuna li se tinjettak, tuża is- siringa mimlija għal- lest b' Neulasta?
Equipment that you need
Apparat li teħtieġ
• a pre-filled syringe of Neulasta; and
siringa mimlija għal- lest b’ Neulasta; u ●
• alcohol wipes or similar.
msielaħ ta’ l- alkoħol jew simili; ●
What should I do before I give myself a subcutaneous injection of Neulasta?
X’ għandi nagħmel qabel ma ninjetta lili nnifsi taħt il- ġilda b’ Neulasta?
Remove from the refrigerator.
Oħroġ s- siringa mimlija għal- lest b’ Neulasta mill- friġġ.
Check the expiry date on the pre-filled syringe label (EXP).
Iċċekkja d- data ta ’ skadenza fuq it- tikketta tas- siringa mimlija għal- lest (JIS/ EXP).
Check the appearance of Neulasta.
Iċċekkja d- dehra ta ’ Neulasta.
Do not warm Neulasta in any other way (for example, do not warm it in a microwave or in hot water).
Issaħħanx Neulasta bl’ ebda mod ieħor (eżempju: issaħħanx fil - forn li jsaħħan l- ikel aktar malajr bil- majkrowejv jew f’ ilma jaħraq).
How do I prepare my Neulasta injection?
38 Kif nipprepara l- injezzjoni ta ’ Neulasta?
Before you inject Neulasta you must do the following:
Qabel ma tinjetta Neulasta trid tagħmel dan li ġej:
Hold the syringe barrel and gently take the cover from the needle without twisting.
Żomm it- tubu tas- siringa u aqla ’ bil- mod l- għatu minn mal - labra mingħajr ma ddawwar jew tgħawweġ.
Injecting the solution with the air bubble is harmless.
Tinjetta il- likwidu bil- bużżieqa ta 'l- arja mhux ta' ħsara.
If someone else is injecting you, they can also use the back of your arms.
ħadd ieħor qed jinjettak, jista ’ wkoll juża in- naħa ta ’ wara ta ’ idejk.
Disinfect your skin by using an alcohol wipe and pinch the skin between your thumb and forefinger, without squeezing it.
Iddisinfetta l- ġilda billi tuża msielaħ ta’ l- akoħol u oqros il- ġilda bejn sebgħek il- kbir u 1. sebgħek il- werrej, mingħajr ma tagħfas.
If you notice a spot of blood at the injection site dab away with a cotton ball or tissues.
Jekk tinnota xi qatra demm fil- post ta 'l- injezzjoni imsaħha b' biċċa tajjar jew tixxu.
Do not rub the injection site.
Togħrokx il- post ta 'l- injezzjoni.
If needed, you may cover the injection site with a bandage.
Jekk hemm bżonn, tista 'tgħatti l- post ta' l- injezzjoni b' faxxa.
Only use each syringe for one injection.
Uża kull siringa għal injezzjoni waħda.
Do not use any Neulasta that is left in the syringe.
M’ għandekx tuża xi Neulasta li jkun baqa ’ fis - siringa.
• Do not put the cover back on used needles.
Terġax tqiegħed l- għatu fuq labar użati. ●
• Keep used syringes out of the reach and sight of children.
Żommu siringi użati ‘ l bogħod minn fejn jistgħu jilħquhom jew jarawhom it- tfal. ●
39 PACKAGE LEAFLET:
39 Is- siringi użati għandhom jintremew kif jitolbu l- liġijiet lokali.
Neulasta 6 mg solution for injection in a pre-filled pen pegfilgrastim
Neulasta 6 mg soluzzjoni għall- injezzjoni ġo pinna mimlija għal- lest pegfilgrastim
White blood cells are important as they help your body fight infection.
Iċ- ċelluli bojod tad - demm huma importanti għaliex jgħinu ‘ l ġismek jiġġieled l- infezzjonijiet.
If white blood cells fall to a low level there may not be enough left in the body to fight bacteria and you may have an increased risk of infection.
Jekk iċ- ċelluli bojod jinżlu għal livell baxx għandu mnejn ma jkunx baqa ’ biżżejjed fil - ġisem biex jiġġieldu ‘ l batterji u jista ’ jkollok riskju ogħla ta ’ infezzjoni.
Your doctor has given you Neulasta to encourage your bone marrow (part of the bone which makes blood cells) to produce more white blood cells that help your body fight infection.
It- tabib tiegħek tak Neulasta biex jgħin il- mudullun (parti mill- għadma li tagħmel iċ- ċelluli tad - demm) jipproduċi aktar ċelluli bojod sabiex ġismek ikun jista ’ jilqa ’ għall- infezzjoni u jiġġildilha.
• if you get left upper abdominal pain or pain at the tip of your shoulder.
jekk inti għandek uġigħ addominali fin- naħa ta ’ fuq jew fit- tarf ta ’ l- ispalla. ●
40 • if you have an allergy to latex.
41 jekk inti allerġiku għall- latex.
The needle cover on the pre-filled pen contains a derivative of latex and may cause severe allergic reactions.
L- għatu tal- labra tal- pinna mimlija għal- lest fih sustanza mnissla ● mill- latex u din tista 'tikkawża reazzjonijiet allerġiċi.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki mediċni li xtrajt mingħajr riċetta.
• plan to become pregnant.
• qed taħseb biex issir tqila
Important information about some of the ingredients of Neulasta
Tagħarif importanti dwar xi uħud mis- sustanzi ta ’ Neulasta
Neulasta contains sorbitol (a type of sugar).
Neulasta fih sorbitol (tip ta ’ zokkor).
Neulasta is essentially sodium- free.
Neulasta huwa essenzjalment mingħajr sodium.
HOW TO USE NEULASTA (SURECLICK)
KIF GĦANDEK TUŻA NEULASTA (SURECLICK)
You should check with your doctor or pharmacist if you are unsure.
Dejjem għandek taċċerta ruħek mat - tabib jew ma ’ l- ispiżjar tiegħek jekk ikollok xi dubju.
The usual dose is one 6 mg subcutaneous injection (injection under your skin) using a pre-filled pen and it should be given approximately 24 hours after your last dose of chemotherapy at the end of each chemotherapy cycle.
Id- doża li ssoltu tingħata hija ta ’ injezzjoni taħt il- ġilda b’ pinna mimlija għal- lest ta ’ 6 mg u li għandha tingħata bejn wieħed u ieħor 24 siegħa wara l- aħħar doża ta ’ kimoterapija fi tmiem kull ċiklu ta ’ kimoterapija.
Do not shake Neulasta vigorously as this may affect its activity.
Tħawwadx Neulasta bil- qawwa għaliex dan jista ’ jeffettwa l- mod kif jaħdem.
Your doctor has decided it would be best f or you to inject Neulasta yourself.
It- tabib jista ’ jiddeċiedi li jkun aħjar għalik jekk tinjetta lilek innifsek b ’ Neulasta.
Your doctor or nurse will show you how to inject yourself.
It- tabib jew l - infermiera tiegħek juruk kif tagħmel dan.
41 If you forget to inject Neulasta
42 Jekk tinsa tieħu Neulasta:
A very common side effect (likely to occur in more than 1 in 10 patients) is bone pain.
Effett sekondarju ieħor komuni ħafna (li hemm ċans li jseħħ f ’ aktar minn pazjent 1 f ’ kull 10 pazjenti) huwa uġigħ fl- għadam.
Your doctor will tell you what you can take to ease the bone pain.
It- tabib jgħidlek x’ tista ’ tieħu biex ittaffi l- uġigħ fl- għadam.
Common side effects (likely to occur in fewer than 1 in 10 patients) include; pain and redness at the site of the injection, headaches, and general aches and pains in the joints, muscles, chest, limbs, neck or back.
Effetti sekondarji oħra komuni (li hemm ċans li jseħħu f ’ anqas minn pazjent 1 f ’ kull 10 pazjenti) jinkludu: uġigħ u ħmura fil- post ta ’ l- injezzjoni, uġigħ ta ’ ras, u uġigħ ġenerali fil- ġogi, il - muskoli, is- sider, ir- riġlejn, l- għonq jew id- dahar.
Allergic-type reactions to Neulasta, including redness and flushing, skin rash, raised areas of the skin that itch and anaphylaxis (weakness, drop in blood pressure, difficulty breathing, swelling of the face), have rarely (likely to occur in fewer than 1 in 1000 patients) been reported.
Reazzjonijiet ta ’ allerġija għal Neulasta, inklużi ħmura u fwawar, raxx tal- ġilda, partijiet tal- ġilda ibbuzzati li jqabbdu l- ħakk u anafilassi (indeboliment, tbaxxija tal- pressjoni tad- demm, tbatija biex tieħu n- nifs, nefħa fil- wiċċ), ġew irrappurtati f’ każijiet rari (li hemm ċans li jseħħu f ’ anqas minn pazjent 1 f ’ kull 1000 pazjent)
Sweet’s syndrome (plum-coloured, raised, painful lesions on the limbs and sometimes the face and neck with fever) has occurred rarely (likely to occur in fewer than 1 in 1,000 patients) but other factors may play a role.
Seħħ rarament (li hemm ċans li jseħħu f ’ anqas minn pazjent 1 f ’ kull 1, 000 pazjent) s- sindromu ta 'Sweet (leżjonijiet ibbuzzati, li jweġgħu, kulur aħmar skur fil- vjola fuq ir- riġlejn u xi drabi fil- wiċċ u fl- ghonq bid- deni) imma fatturi oħra jistgħu jkollhom sehem f' dan.
Do not use Neulasta after the expiry date which is stated on the box and on the pen label (EXP).
43 Tużax Neulasta wara d- data ta ’ skadenza li tidher fuq il- kaxxa u fuq it- tikketta tal- pinna (JIS/ EXP).
Once a pre-filled pen has been removed from the refrigerator and has reached room temperature (not above 30°C) it must either be used within 3 days or disposed of.
La darba siringa tkun tneħħiet mill- friġġ u tkun laħqet temperatura ambjentali (mhux aktar minn 30°C) għandha tintuża fi żmien 3 ijiem jew tintrema.
42 Do not freeze.
Tagħmlux fil- friża.
Neulasta may be used if it is accidentally frozen for a single period of less than 24 hours.
Neulasta jista ’ jintuża jekk jiġi ffriżat bi żball għal perjodu wieħed ta ’ inqas minn 24 siegħa
It belongs to a group of proteins called cytokines, and is very similar to a natural protein (granulocyte-colony stimulating factor) produced by your own body.
Huwa parti minn grupp ta ’ proteini msejħa ċitokini, u jixbaħ ħafna lill- proteina naturali (fattur li jistimola l- kolonji ta ’ granuloċiti) li hija prodotta mill - ġisem tiegħek.
Each pre-filled pen contains 6 mg of pegfilgrastim in 0.6 ml of solution.
Kull pinna mimlija għal- lest fiha 6 mg ta ’ pegfilgrastim f ’ soluzzjoni ta ’ 0. 6 ml.
Neulasta is a solution for injection in a pre-filled pen (6 mg/0.6 ml).
Neulasta huwa soluzzjoni għall- injezzjoni ġo pinna mimlija għal- lest (6 mg / 0. 6ml).
Each pack contains 1 pre-filled pen.
Kull pakkett fiħ pinna waħda mimlija għal- lest.
Amgen Europe B.V.
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- suq u l- Manifattur Amgen Europe B. V.
If you want more information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Għal kull tagħrif dwar din il- mediċina, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- suq.
Magyarország
44 Magyarország България Amgen Kft.
This leaflet was last approved in.
45 Dan il- fuljett kien approvat l- aħħar f ’.
44 Instructions for injecting with the Neulasta pre-filled pen (SureClick)
Tagħrif dwar kif tinjetta lilek innifsek b' pinna mimlija għal- lest b' Neulasta (SureClick)
This section contains information on how to properly use the Neulasta pre-filled pen.
Din il- parti tal- fuljett tinkludi tagħrif dwar kif tuża sew il- pinna mimlija għal- lest b' Neulasta.
How do you, or the person injecting you, use Neulasta pre-filled pen (SureClick)?
Kif inti, jew il- persuna li se tinjettak, tuża il- pinna mimlija għal- lest b' Neulasta (SureClick)?
Equipment:
Apparat:
• a new Neulasta pre-filled pen and
pinna ġdida mimlija għal- lest b’ Neulasta; u ●
Preparing for a Neulasta injection?
Tipprepara għall- injezzjoni b 'Neulasta?
Remove from the refrigerator.
Oħroġ il- pinna mimlija għal- lest mill- friġġ.
Do not remove the grey needle shield from the pre-filled pen until you are ready to inject.
Tneħħix l- għatu griż tal- labra tal- pinna mimlija għal- lest qabel ma tkun lest biex tinjetta.
Do not use it if the date has passed the last day of the month shown
Tużax jekk id- data qabżet l- aħħar ġurnata tax- xahar muri.
Check the appearance of Neulasta through the inspection window.
Iċċekkja d- dehra ta ’ Neulasta minn ġo t- tieqa għal ispezzjoni.
It must be a clear and colourless liquid.
Il- likwidu għandu jkun ċar u mingħajr kulur.
For a more comfortable injection, leave at room temperature for approximately 30 minutes.
Għal injezzjoni aktar komda, ħalli il- pinna mimlija għal- lest toqgħod għal 30 minuta f' temperatura ambjentali.
Do not warm Neulasta in any other way (for example, do not warm it in a microwave or in hot water).
Issaħħanx Neulasta bl’ ebda mod ieħor (eżempju: issaħħanx fil- forn li jsaħħan l- ikel aktar malajr bil- majkrowejv jew f’ ilma jaħraq).
Find a comfortable, well-lit, clean place and put all the equipment you need within reach.
Sib post nadif, komdu, u mdawwal sew, u poġġi dak kollu li teħtieġ fejn tista 'tilħaqhom.
45
Tieqa għal ispezzjoni
Before use (with grey needle shield)
46 Qabel l- użu (bl- għatu ta 'sigurtà griż tal- labra)
Before use (without grey needle shield)
Qabel l- użu (mingħajr l- għatu ta 'sigurtà griż tal- labra)
After use (needle safety cover down)
Wara l- użu (l- għatu ta 'sigurtà tal- labra mniżżel)
To perform a successful injection a firm injection area is required.
Biex tinjetta lilek nnifsek sew għandek issib parti soda fejn tinjetta.
The recommended sites for injection using the pre-filled pen are the top of the thigh and the back of the arm if given by a nurse or carer (see picture 1).
Il- partijiet rakkomandati għal injezzjoni b' pinna mimlija għal- lest huma in- naħa ta ’ fuq ta ’ kuxxtejk u in- naħa ta ’ wara ta ’ idejk jekk l - injezzjoni tingħata minn infermiera jew carer (ara stampa 1).
The abdomen can be considered when the thigh and back of arm are judged by a healthcare professional to be inappropriate.
Kif nagħti l- injezzjoni fil- koxxa jew fin- n- naħa ta ’ wara ta’ l- id
give an injection into the thigh or back of the arm
• Iddisinfetta l- ġilda billi tuża msielaħ ta’ l- akoħol.
2.
2. • Neħħi l- għatu griż tal- labra (ara Stampa 2).
• Remove the grey needle shield (see picture 2).
• Il- pinna mimlija għal- lest għandha għatu ta 'sigurtà li jipproteġik minn tingiż bil- labra jew minn telfien tal- mediċina jekk titmiss jew titħabbat il- labra bi żball.
Important information for Step A of the injecting process.
Tagħrif importanti għal Pass A tal- proċess ta 'l- injezzjoni.
Press the pre-filled pen firmly enough against the skin so that the safety cover is fully retracted (see picture 3).
Agħfas il- pinna mimlija għal- lest b' mod sod mal- ġilda biżżejjed sabiex l- għatu ta 'sigurtà jidħol' l ġewwa kompletament (ara stampa
Safety cover
Safety cover
Safety cover
Safety cover Għatu ta 'sigurtà 3).
out
Għatu ta 'out
fully retracted
fully retracted
At start, keep thumb clear of green button A.
47 Fil- bidu, keep thumb clear of At start, żżommx sebgħek il- kbir fuq il- buttuna ħadra green button
Place the pre-filled pen on the injection site at a right angle (90 degrees) and push firmly against the skin.
Poġġi il- pinna mimlija għal- lest fuq il- parti fejn se tinjetta b' angolu ta '90 grad u għafas sod mal- ġilda.
Hold down (see picture).
Żomm l- isfel (ara Stampa).
46 2 release
2 itlaq Klik
1 press While holding the pre-filled pen in place, (1) press and (2)
Waqt li żżomm il- pinna mimlija għal- lest fil- post, (1) għafas u B.
release the green button on top.
(2) itlaq il- buttuna il- ħadra li hemm in- naħa ta 'fuq.
You will hear a “click”.
Għandek tisma 'ħoss ta' “ klik ”.
Do not lift the pre-filled pen.
Tgħollix il- pinna mimlija għal- lest.
C.
Klik
After the second “click” (or count of 15) lift pre-filled pen from the injection site.
Wara t- tieni ħoss ta '“ klik ” (jew għodd sa 15) għolli l- pinna C. mimlija għal- lest mill- post ta' l- injezzjoni.
If you experience difficulties choose a more firm injection site
Jekk tesperjenza xi diffikultajiet agħżel post aktar sod għall- injezzjoni.
The needle safety cover will move down over the needle and lock into place.
L- għatu ta 'sigurtà tal- labra jinżel' l isfel għal fuq il- labra u jorbot f' postu.
The inspection window will be green, confirming the injection is complete.
It- tieqa għal ispezzjoni tkun ħadra, b' hekk tikkonferma li l- injezzjoni hija kompluta.
Only use a single Neulasta pre-filled pen for each injection.
Uża pinna mimlija għal- lest ta 'Neulasta waħda għal kull injezzjoni.
The objective of the skin pinch technique is to create a firm site for the injection
Agħżel post mill- anqas 5cm 'il bogħod miż- żokkra (ara stampa 4).
Choose a site at least 5 cm away from the belly button (navel) (see picture 4).
Żomm sod il- ġilda maqrusa tul il- proċess kollu (ara stampa 5).
Important information for Step A of the injecting process.
Tagħrif importanti għal Pass A tal- proċess għall- injezzjoni.
Press the pre-filled pen firmly enough against the skin so that the safety cover is fully retracted (see picture 6).
Agħfas b' mod sod il- pinna mimlija għal- lest mal- ġilda biżżejjed biex l - għatu ta 'siġurtà jinġibed lura (ara stampa 6).
The pre-filled pen has a safety cover that will protect you from needle Safety cover sticks or loss of drug by accidental bumping or touching.
Għatu ta 'sigurtà Għatu ta' Il- pinna mimlija għal- lest għandha għatu ta 'sigurtà li jipproteġik minn tingiż bil- labra jew minn telfien tal- mediċina jekk titmiss jew titħabbat il- labra bi żball.
Safety cover out
sigurtà barra
fully retracted
mdaħħal 'l ġewwa
47 At start, keep thumb clear of green button
Fil- bidu, żżommx
Centre the pre-filled pen in the area of the pinched skin at a right angle (90 degrees) and push firmly against the skin.
Iċċentra l- pinna mimlija għal- lest fuq il- ġilda maqrusa b 'angolu ta' 90 grad u agħfas sod mal- ġilda.
Hold down.
Żomm 'l isfel
2 release
2 itlaq
Maintaining firm skin pinch, (1) press and (2) release the green button on top.
Terfax il- pinna mimlija għal- lest.
B.
1 għafas
After the second “click” (or a count of 15) lift the pre-filled pen from the injection site.
Wara it- tieni ħoss ta '“ klik ” (jew għodd sa 15) erfa' il- pinna mimlija għal- lest mill- post ta 'l- injezzjoni.
If you experience difficulties choose a more firm injection site.
Jekk tesperjenza xi diffikultajiet għażel post aktar sod għall- injezzjoni.
The needle safety cover will move down over the needle and lock into place.
49 L- għatu ta 'sigurtà tal- labra jinżel' l isfel għal fuq il- labra u jorbot f' postu.
Only use a single Neulasta pre-filled pen for each injection.
Uża pinna mimlija għal- lest b' Neulasta waħda għal kull injezzjoni.
Disposing of used pre-filled pens
Rimi ta’ pinnen mimlija għal- lest użati
• Due to the protective safety cover it is not recommended to put the grey needle shield back on the used pre-filled pen.
Minħabba l- għatu ta 'sigurtà mhux rakkomandat li terġa' tqiegħed l- għatu griż tal- labra fuq il - ● pinna mimlija għal- lest użata.
• Keep used pens out of the reach and sight of children.
Żommu pinnen użati ‘ l bogħod minn fejn jistgħu jilħquhom jew jarawhom it- tfal. ●
• The used pre-filled pen should be disposed of in accordance with local requirements.
Il- pinnen mimlija għal- lest użati għandhom jintremew kif jitolbu l- liġijiet lokali.
Ask your pharmacist how to dispose of medicines no longer required.
Staqsi lill - ● ispiżjar dwar kif għandek tarmi mediċini li m’ għankekx bżonn.
These measures will help to protect the environment
Dawn il- miżuri jgħinu għall - protezzjoni ta ’ l- ambjent.
48 PACKAGE LEAFLET:
50 FULJETT TA ’ TAGĦRIF:
Neulasta 6 mg solution for injection in a pre -filled syringe pegfilgrastim
Neulasta 6 mg soluzzjoni għall- injezzjoni ġo siringa mimlija għal- lest pegfilgrastim
• if you get left upper abdominal pain or pain at the tip of your shoulder;
jekk inti għandek uġigħ addominali fin- naħa ta ’ fuq jew fit- tarf ta ’ l- ispalla; •
• if you have an allergy to latex.
51 jekk inti allerġiku għall- latex.
The needle cover on the pre-filled syringe contains a derivative of latex and may cause severe allergic reactions.
L- għatu tal- labra tal- siringa mimlija għal- lest fih sustanza mnissla • mill- latex u din tista 'tikkawża reazzjonijiet allerġiċi.
49 Using other medicines
Meta tieħu mediċini oħra
50 If you forget to inject Neulasta
52 Jekk tinsa tieħu Neulasta:
Do not use Neulasta after the expiry date which is stated on the box and on the syringe label (EXP).
53 Tużax Neulasta wara d- data ta ’ skadenza li tidher fuq il- kaxxa u fuq it- tikketta tas- siringa (JIS).
51 Do not freeze.
Tagħmlux fil- friża.
Neulasta is a solution for injection in a pre-filled syringe (6 mg/0.6 ml).
Neulasta huwa soluzzjoni għall- injezzjoni ġo siringa mimlija għal- lest (6 mg / 0. 6ml).
Each pack contains 1 pre-filled syringe.
Kull pakkett fih siringa waħda mimlija għal- lest.
The syringes are provided either with or without an automatic needle guard or blister wrapping.
Is- siringi huma disponibbli bi jew bla għatu ta ’ protezzjoni tal- labra awtomatiku, ġo folja jew mingħajr folja.
België/Belgique/Belgien s.a.
54 Luxembourg/ Luxemburg België/ Belgique/ Belgien s. a.
United Kingdom Amgen Limited Tel: +44 (0)1223 420305
55 United Kingdom Latvija Amgen Limited Amgen Switzerland AG Rīgas filiāle Tel: +44 (0) 1223 420305 Tel: +371 29284 807
53 This leaflet was last approved in.
Dan il- fuljett kien approvat l- aħħar f ’.
INSTRUCTIONS FOR INJECTING WITH THE NEULASTA PRE-FILLED SYRINGE
TAGĦRIF DWAR KIF TINJETTA LILEK INNIFSEK B’ NEULASTA SIRINGA MIMLIJA GĦAL- LEST
This section contains information on how you, or the person injecting you, use the Neulasta pre-filled syringe.
Din is- sezzjoni fiha informazzjoni dwar kif int, jew il- persuna li ħa tinjettak, tuża Neulasta siringa mimlija għal- lest.
It is important that you do not try to give yourself the injection unless you have received training from your doctor, nurse or pharmacist.
Huwa importanti li ma tippruvax tagħti l- injezzjoni lilek innifsek jekk ma tkunx irċevejt taħriġ mit- tabib, infermiera jew spiżjar tiegħek.
If you have questions about how to inject, please ask your doctor, nurse or pharmacist for assistance.
Jekk għandek xi mistoqsijiet dwar kif tinjetta, jekk jogħġbok staqsi lit- tabib, lill- infermiera jew lill- ispiżjar tiegħek għall- għajnuna.
Before you begin
Qabel tibda
Read all instructions thoroughly before using the pre-filled syringe.
Qara ’ sew l- istruzzjonijiet kollha qabel tuża s- siringa mimlija għal- lest.
To reduce the risk of accidental needle sticks to users, each pre-filled syringe is equipped with a needle guard that is automatically activated to cover the needle after complete delivery of the pre-filled syringe content.
Biex tnaqqas ir- riskju ta ’ tingiż aċċidentali bil- labra lil dawk li qed jużawh, kull siringa mimlija għal - lest hija mgħammra b’ għatu ta ’ protezzjoni tal- labra li huwa attivat awtomatikament biex jgħatti l - labra wara l- għoti komplet tal- kontenut tas- siringa mimlija għal- lest.
DO NOT attempt to unlock the pre-filled syringe prior to injection.
TIPPRUVAX tiftaħ is- siringa mimlija għal- lest qabel l- injezzjoni.
DO NOT use the pre-filled syringe if the needle cover has been removed, or the needle guard has been activated (covering the needle).
TUŻAX is- siringa mimlija għal- lest jekk l- għatu tal- labra tneħħa, jew l- għatu ta ’ protezzjoni tal- labra ġie attivat (jgħatti l- labra).
How do I use the Neulasta pre-filled syringe?
Kif nuża Neulasta siringa mimlija għal- lest?
Your doctor has prescribed an Neulasta pre-filled syringe for injection into the tissue just under the skin.
It- tabib tiegħek ippreskrivilek Neulasta siringa mimlija għal- lest għall- injezzjoni fit- tessut eżatt taħt il - ġilda.
Your doctor, nurse, or pharmacist will tell you how much Neulasta you need and how frequently it should be injected.
It- tabib, infermiera, jew spiżjar tiegħek se jgħidulek kemm għandek bżonn Neulasta u l - frekwenza ta ’ l- injezzjonijiet.
To give yourself an injection you will need:
Biex tagħti injezzjoni lilek innifsek teħtieġ:
• a new Neulasta pre-filled syringe; and
• Neulasta siringa mimlija għal- lest ġdida; u
• alcohol wipes or similar.
• msielaħ ta ’ l- alkoħol jew simili.
What should I do before I give myself a subcutaneous injection of Neulasta?
X’ għandi nagħmel qabel ma ninjetta lili nnifsi taħt il- ġilda b ’ Neulasta?
Remove the pre-filled syringe from the refrigerator.
Neħħi s- siringa mimlija għal- lest mill- friġġ.
Do not pick up the pre-filled syringe by the plunger or needle cover.
Taqbadx is- siringa mimlija għal- lest mill- planġer jew mill- għatu tal- labra.
This could damage the device.
Dan jista ’ jagħmel ħsara lill- apparat.
Leave the pre-filled syringe at room temperature for approximately 30 minutes.
Ħalli s- siringa mimlija għal- lest toqgħod f’ temperatura ambjentali għal madwar 30 minuta.
This will make the injection more comfortable.
Dan jagħmel l- injezzjoni aktar komda.
Do not warm Neulasta in any other way (for example, in a microwave or in hot water).
Issaħħanx Neulasta bl- ebda mod ieħor (eżempju: fil - majkrowejv jew f’ ilma jaħraq).
Do not leave the syringe exposed to direct sunlight.
Tħallix is- siringa esposta għax- xemx diretta
Do not remove the cover from the pre-filled syringe until you are ready to inject.
Tneħħix l- għatu minn mas- siringa mimlija għal- lest qabel ma tkun lest biex tinjetta.
Check the expiry date on the pre-filled syringe label (EXP:).
Iċċekkja d- data ta ’ skadenza fuq it- tikketta tas- siringa mimlija għal- lest (EXP:).
Do not use it if the date has passed the last day of the month shown.
Tużahiex jekk id- data qabżet l- aħħar ġurnata tax- xahar muri.
It must be a clear and colourless liquid.
Dan għandu jkun likwidu ċar, mingħajr kulur jew kemmxejn lewn il- perla.
If it is cloudy or there are particles in it, you must not use it.
Jekk ikun imċajpar jew jekk ikun fih xi frak, m’ għandekx tużah.
Find a comfortable, well-lit, clean surface and put all the equipment you need within reach.
Sib post komdu, mdawwal sew, naddaf il- wiċċ, u poġġi l- apparat kollu li għandek bżonn fejn tista ’ tilħaqhom.
Where should I give my injection?
Fejn għandi nagħti l- injezzjoni tiegħi?
The best places to inject yourself are the top of your thighs and the abdomen.
L- aħjar postijiet fejn tinjetta lilek innifsek huma in- naħa ta ’ fuq ta ’ kuxxtejk u l- addome.
If someone else is injecting for you, they can also use the back of your arms.
Jekk xi ħadd ieħor qed jinjettak, jista ’ wkoll juża n- naħa ta ’ wara ta ’ dirgħajk.
Change the injection site if you notice the area is red or sore.
Ibdel is- sit ta ’ l- injezzjoni jekk tinnota ħmura jew tbenġil.
How do I give my injection?
Kif nagħti l- injezzjoni tiegħi?
Disinfect your skin by using an alcohol wipe.
Iddisinfetta l- ġilda tieħek billi tuża mselħa ta ’ l- alkoħol.
To avoid bending the needle, gently pull the cover from the needle straight off without twisting as shown.
Biex tevita ’ li tgħawweġ il- labra, iġbed bil- mod l- għatu mill- labra dritt ’ l barra mingħajr ma ddawwar kif muri.
You may notice a small air bubble in the pre-filled syringe.
Għandek mnejn tinnota bużżieqa ta ’ l- arja żgħira fis - siringa mimlija għal- lest.
You do not have to remove the air bubble before injecting.
M’ għandekx għalfejn tneħħi l - bużżieqa ta ’ l- arja qabel tinjetta.
Injecting the solution with the air bubble is harmless.
Li tinjetta s- soluzzjoni bil- bużżieqa ta ’ l- arja hija bla periklu.
Pinch (without squeezing) the skin between your thumb and forefinger.
Oqros (mingħajr ma tgħafas) il- ġilda bejn is- sebgħa l- kbir u l- werrej.
Put the needle fully into the skin as shown by your nurse or doctor.
Daħħal il- labra kollha fil - ġilda kif urewk l- infermiera jew it- tabib tiegħek.
Pull slightly on the plunger to check that a blood vessel has not been punctured.
Iġbed kemmxejn il- planġer tas- siringa sabiex tara li ma ttaqbitx xi vina jew arterja.
If you see blood in the syringe, pull the needle out and re-insert it in another place after disinfecting the skin.
Jekk tara d - demm fis- siringa, iġbed l- labra ’ l barra u wara li tiddisinfetta l- ġilda erġa ’ daħħalha f’ post ieħor.
Push the plunger with a slow constant pressure, always keeping your skin pinched.
Imbotta l- planġer bi pressjoni baxxa u kostanti, waqt li dejjem iżżomm il- ġilda maqrusa.
Push the plunger all the way down as far as it will go to inject all the liquid.
Imbotta l- planġer l- isfel sakemm jista ’ jinżel biex tinjetta l- likwidu kollu.
The needle guard will not activate unless you empty the pre-filled syringe.
L- għatu ta ’ protezzjoni tal- labra mhux se jiġi attivat jekk ma tkunx battalt is- siringa mimlija għal- lest.
55 7.
57 7.
While the plunger is still pressed all the way down, remove the needle from the skin, then release the plunger and allow the syringe to move up until the entire needle is covered by the needle guard.
Waqt li l- planġer ikun għadu magħfus kollu l- isfel, neħħi l- labra minn ġol- ġilda, wara erħi l - planġer u ħalli s- siringa titla ’ ’ l fuq sakemm il- labra kollha hija mgħottija bl- għatu ta ’ protezzjoni tal- labra.
If the needle guard is not activated, an incomplete injection may have occurred.
Jekk l- għatu ta ’ protezzjoni tal- labra ma jkunx attivat, għandu mnejn tkun ingħatat injezzjoni mhux kompleta.
Call your health care provider if you think you have not received the full dose.
Jekk taħseb li ma rċevejtx id- doża sħiħa kellem lill - professjonist fil- kura tas- saħħa tiegħek.
DO NOT put the needle cover back on the needle.
TPOĠĠIX lura l- għatu tal- labra fuq il- labra.
If you notice a spot of blood you may gently dab it away with a cotton ball or tissue.
Jekk tinnota qatra demm tista ’ timsaħha b’ biċċa tajjar jew tixxju.
If needed, you may cover the injection site with a plaster.
Jekk hemm bżonn, tista ’ tgħatti s- sit ta ’ l- injezzjoni b’ biċċa stikk.
Only use each pre-filled syringe for one injection.
Uża kull siringa mimlija għal- lest għal injezzjoni waħda biss.
Do not use any Neulasta that is left in the syringe.
Tużax xi Neulasta li jkun fadal ġewwa s- siringa.
If you have any problems, please ask your doctor or nurse for help and advice.
Jekk għandek xi problemi, jekk jogħġbok staqsi lit- tabib jew lill- infermiera tiegħek għal għajnuna u parir
• You do not need to put the needle cover back on used syringes. • Keep used syringes out of the reach and sight of children. • The used syringe should be disposed of in accordance with local requirements.
• M’ għandekx għalfejn tpoġġi lura l- għatu tal- labra fuq siringi użati. • Żomm siringi użati fejn ma jintlaħqux u ma jidhrux mit- tfal. • Is- siringi użati għandhom jintremew kif jitolbu l- liġijiet lokali.
ed This document is a summary of the European Public Assessment Report (EPAR).
t za Dan id- dokument huwa sommarju tar- Rapport ta ’ Valutazzjoni Pubblika Ewropew (EPAR).
It explains how
Huwa
is the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.
riz jispjega kif il- Kumitat għal Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) ivvaluta l- istudji mwettqa, sabiex jaslu għar- rakkomandazzjonijiet tagħhom dwar kif tintuża l- mediċina.
or If you need more information about your medical condition or your treatment, read the Package
to Jekk inti teħtieġ aktar informazzjoni dwar il- kundizzjoni medika tiegħek jew it- trattament tiegħek, aqra l- Fuljett ta ’ Tagħrif (huwa parti wkoll mill- EPAR) jew ikkuntattja lit- tabib jew lill- ispiżjar
th Leaflet (also part of the EPAR) or contact your doctor or pharmacist.
aw tiegħek.
If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part
Jekk trid aktar informazzjoni abbażi tar- rakkomandazzjonijiet ta ’ CHMP, aqra d - Diskussjoni Xjentifika (ukoll parti mill- EPAR).
er What is Neupopeg?
x du X' inhu Neuopopeg?
Neupopeg is a solution for injection that contains the active ingredient pegfilgrastim.
Neupopeg hu soluzzjoni għall- injezzjoni li fiha s- sustanza attiva pegilgrastim.
It is available in ng a pre-filled syringe and a pre-filled pen (SureClick), each containing 6 mg pegfilgrastim. lo
Huwa disponibbli ħa f’ siringa mimlija minn qabel u f’ forma ta ’ pinna mimlija minn qabel (SureClick) li kull waħda fiha 6 mg ta ’ pegfilgrastim. ’ g
What is Neupopeg used for?
Għal x’ hiex jintuża Neupopeg? m
Chemotherapy (cancer treatment) that is cytotoxic (cell-killing) also kills white blood cells, which can lead to neutropenia (low white blood cell counts) and the development of infections.
Il - kemoterapija (trattament tal- kanċer) lihuwa ċitotissiku (joqtol iċ- ċelloli) joqtol ukoll iċ- ċelloli bojod li
Neupopeg is used to reduce the duration of neutropenia and the occurrence of febrile neutropenia (neutropenia with ct
tad- demm, li jistgħu jwasslu għal newtropenija (tnaqqis fil- għadd ta ’ ċelloli bojod fid- demm) u l - li
fever). du
iżvilupp ta ’ infezzjonijiet.
Neupopeg can be used for many types of cancer, except for chronic myeloid leukaemia (a cancer of the white blood cells).
jkun hemm newtropenija febbrili (newtropenija bid- deni).
It also cannot be used in patients with myelodysplastic syndromes, a disease in which too many white blood cells are produced, and which can develop into leukaemia. ro
Neupopeg jista ’ jintuża għal bosta tipi ta ’ kanċer, ħlief il- lewkemja mijelojde kronika (kanċer taċ - in
The medicine can only be obtained with a prescription. lp
Il- mediċina tista ’ tinkiseb biss b’ riċetta tat- tabib. ed
How is Neupopeg used? a
Kif jintuża Neupopeg? tm
Neupopeg treatment should be initiated and supervised by a doctor who has experience in the treatment of cancer or blood disorders.
Trattament Neupopeg għandu jinbeda u jiġi sorveljat minn tabib li għandu esperjenza fil- kura ta ’ pazjenti bil- kanċer jew problemi fid- demm.
Neupopeg is given as a single 6 mg injection under the skin in
Neupopeg tingħata bħal injezzjoni waħda ta ’ 6 mg taħt il - ġilda madwar 24 siegħa wara t- tmeim ta ’ kull ċiklu ta ’ kemoterapija.
around 24 hours after the end of each cycle of chemotherapy.
rwieħhom ladarba dawn jiġu mħarrġa b’ mod xieraq.
Patients can inject themselves if they ic
Neupopeg mhux rakkomandat għat- tfal, od
Neupopeg is not recommended for use in children, due to a lack of information on its safety and effectiveness in this group. ed
Pr
M
Kif jaħdem Neupopeg?
The active substance in Neupopeg, pegfilgrastim, is an immunostimulant that belongs to the group ‘ colony stimulating factors’.
Is- sustanza attiva Neupopeg, pegilgrastim hija immunostimulant li jaqa ’ fil- grupp ta ’ ‘ fatturi ta ’ stimulazzjoni tal- kolownja ’.
The filgrastim in Neupopeg is produced by a method known as ‘ recombinant DNA technology’: it is made by a bacterium that has received a gene (DNA), which makes it able to produce filgrastim.
Il- filgrastim f’ Neupopeg jiġi prodott b' metodu magħruf bħala teknoloġija 'rikombinanti tad- DNA ’: hija magħmula minn batterju li tkun irċiviet ġene (DNA), li jagħmilha kapaċi tipproduċi filgrastim.
How has Neupopeg been studied?
Kif ġie studjat Neupopeg?
Neupopeg has been studied in two main studies involving 467 patients with breast cancer who were being treated with cytotoxic chemotherapy.
Neupopeg ġiet studjata f’ żewġ studji prinċipali li jinvolvu 467 pazjent bil- kanċer tas- sider li kienu qed jiġu trattati bil- kemoterapija ċitototossika.
In both studies, the effectiveness of a single injection of Neupopeg was compared with multiple daily injections of filgrastim during each of four chemotherapy cycles.
Fiż- żewġ studji, l- effikaċja ta ’ injezzjoni waħda ta ’ Neupopeg ġiet kumparata ma ’ diversi injezzjonijiet ta ’ kuljum ta ’ filgrastim matul kull ċiklu ta ’ erba ’ kemoterapiji.
What benefit has Neupopeg shown during the studies?
X’ benefiċċju wera Neupopeg matul l- istudji?
ed Neupopeg was as effective as filgrastim in reducing the duration of severe neutropenia.
t za Neupopeg kienet effettiva bħala filgrastim fit- tnaqqis ta ’ żmien ta ’ newtropenija severa.
In both studies, the patients had severe neutropenia for around 1.7 days during their first chemotherapy cycle.
Fiż- żewġ studji, il- pazjenti kellhom newtropenija severa għal madwar 1. 7 jum matul iċ- ċiklu ta ’ l- ewwel
is What is the risk associated with Neupopeg?
riz kemoterapija tagħhom.
or Most of the side effects seen in patients taking Neupopeg in studies are due to their underlying disease or chemotherapy.
to X’ inhu r- riskju assoċjat ma ’ Neupopeg?
The most common side effects with Neupopeg (seen in more than 1 in 10 patients)
Bosta effetti sekondarji f’ pazjenti li jieħdu Neupopeg fi studji huma dovoti għal marda jew
th are bone pain and raised levels of lactate dehydrogenase (a marker of red blood cell breakdown).
L- aktar effetti sekondarji komuni b’ Neupopeg (murija f’ aktar minn pazjent minn kull 10) huma ugiegħ fl- għadam u livelli miżjuda ta ’ diħirogenażju lattaż (markatur ta ’ tkissir ta ’ ċellola ħamra tad- demm).
For
x Tagħrif.
au the full list of all side effects reported with Neupopeg, see the Package Leaflet.
du Neupopeg m’ għandhiex tintuża minn persuni ipersensittivi (allergici) ghal pegfilgrastim jew għal xi ingredjenti oħra tiegħu. ħa Għaliex ġie approvat Neupopeg?
Neupopeg should not be used in people who may be hypersensitive (allergic) to pegfilgrastim or any of the other ingredients.
Il- Kumitat għal Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) ddeċieda li l- benefiċċji ta ’ ’ g
Why has Neupopeg been approved? er ng The Committee for Medicinal Products for Human Use (CHMP) decided that Neupopeg’ s benefits are greater than its risks for the reduction of the duration of neutropenia and the incidence of febrile lo neutropenia in patients treated with cytotoxic chemotherapy for malignancy.
Neupopeg huma akbar mir- riskji tagħha għat- tnaqqis taż- żmien ta ’ newtropenija u l- inċidenza ta ’ m
The Committee recommended that Neupopeg be given marketing authorisation. no
Il- Kumitat jirrakkomanda li Neulasta tingħata awtorizzazzjoni għal tqegħid fis- suq. li
Other information about Neupopeg:
Tagħrif ieħor dwar Neupopeg: li
The European Commission granted a marketing authorisation valid throughout the EU for Neupopeg ct
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- Unjoni Ewropea a
to Dompé Biotec S. p. A. on 22 August 2002.
kollha, għal Neupopeg lil Dompé Biotec S. p. A. fit- 22 ta ’ Awwissu2002.
The marketing authorisation was renewed on 22 August 2007. du
tqegħid fis- suq ġiet aġġornata fit- 22 ta ’ Awwissu 2007. iċ
The full EPAR for Neupopeg can be found here. ro lp
http: // www. emea. europa. eu/ humandocs/ Humans/ EPAR/ neupopeg/ neupopeg. htmL- EPAR sħiħ għal ed
This summary was last updated in 02-2008. a in ic ed M
Neupopeg jista ’ jinstab hawnhekk tm
EU Number
Mnejn jingħata
Invented
Kontenut
Strength
at Numru ta ’ l- EU
Pharmaceutical
Isem
Packaging
Għamla farmaċewtika
d Package size
(konċentrazzjoni)
Solution for
soluzzjoni għall
Subcutaneous
Użu għal taħt il- ġilda
0.6 ml (10 mg/ ml)
siringa mimlija għal- lest 0. 6 ml (10 mg/ ml)
1 pre-filled
Siringa waħda mimlija
syringe (glass)
(ħġieġ)
syringe
għal- lest
injection
(ħġieġ)
syringe (glass)
għal- lest (mhux ġo folja)
u without blister EU/ 1/ 02/ 228/ 003
aw EU/ 1/ 02/ 228/ 003
pre-filled pen
pinna mimlija għal- lest (ħġieġ) (SureClick)
1 pre-filled pen
x du a għ ’ im il al in iċ d e m tt o od r P 1/ 1
ed is or th au ANNEX Ier ng SUMMARY OF PRODUCT CHARACTERISTICS lo o tn uc od pr al in ic ed M 1.
SOMMARJU TAL- KARATTERISTIĊI TAL- PRODOTT ’ g m li i al in iċ ed tm ot od Pr
Neupopeg 6 mg solution for injection.
Neupopeg 6 mg soluzzjoni għall- injezzjoni.
*Produced in Escherichia coli cells by recombinant DNA technology followed by conjugation with polyethylene glycol (PEG). ** The concentration is 20 mg/ ml if the PEG moiety is included
* Magħmul f ’ ċellui ta ’ Escherichia coli b ’ teknoloġija rikombinanti- DNA u wara b ’ konjugazzjoni ma ’ polyethylene glycol (PEG). ** Il- konċentrazzjoni hija ta ’ 20 mg/ ml jekk tiġi nkluża l- porzjoni PEG.
ed Excipients:
t za Sustanzi mhux attivi:
is or Excipients known to have a recognised action: sorbitol E420, sodium acetate (see section 4.4).
riz to Sustanzi mhux attivi li għandhom azzjoni magħrufa: sorbitol E- 420, sodium acetate (ara sezzjoni 4. 4).
th For a full list of excipients, see section 6.1.
aw Għal- lista kompleta ta 'sustanzi mhux attivi, ara sezzjoni 6. 1.
au 3.
x du 3.
PHARMACEUTICAL FORM er ng
GĦAMLA FARMAĊEWTIKA ħa
Solution for injection. lo
Soluzzjoni għall- injezzjoni. ’ g
Clear, colourless solution for injection. o tn uc
Soluzzjoni għall- injezzjoni ċara u mingħajr kulur. m li i
CLINICAL PARTICULARS od
TAGĦRIF KLINIKU al in
4.1 Therapeutic indications pr
4. 1 Indikazzjonijiet terapewtiċi iċ ed
Reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and al
Tnaqqis fid- dewmien tan- newtropenja u ta ’ l- inċidenza ta ’ newtropenja bid- deni f’ pazjenti kkurati b’ kimoterapija ċitotossika għal tumur malinn (bl- eċċezzjoni ta ’ lewkimja majelojde kronika u tm
myelodysplastic syndromes). in ic
sindromi majelodisplastiċi). ot
4.2 Posology and method of administration ed
4. 2 Pożoloġija u metodu ta ’ kif għandu jingħata od
Neupopeg therapy should be initiated and supervised by physicians experienced in oncology and/ or M
Il- kura b’ Neupopeg għandha tinbeda u tiġi segwita minn tobba b’ esperjenza fl- onkoloġija u/ jew fl - Pr
haematology.
ematoloġija.
One 6 mg dose (a single pre-filled syringe) of Neupopeg is recommended for each chemotherapy cycle, administered as a subcutaneous injection approximately 24 hours following cytotoxic chemotherapy.
Doża waħda ta ’ 6 mg (siringa waħda mimlija għal- lest) ta ’ Neupopeg hija rrakkomandata għal kull ċiklu ta ’ kimoterapija, mogħtija bħala injezzjoni taħt il- ġilda bejn wieħed u ieħor 24 siegħa wara l - kimoterapija ċitotossika.
Neupopeg is not recommended for use in children under 18 years of age due to insufficient data on safety and efficacy.
Neupopeg mhux rakkomandat għall- użu fit- tfal taħt it- 18- il sena minħabba nuqqas ta ’ informazzjoni dwar is- sigurtà u l- effikaċja.
4.4 Special warnings and precautions for use
2 4. 4 Twissijiet speċjali u prekawzjonijiet għall- użu
However, the long-term effects of Neupopeg have not been established in acute myeloid leukaemia; therefore, it should be used with caution in this patient population.
Mandanakollu, l- effett fit- tul ta 'Neupopeg għad ma ġiex stabbilit f' lewkimja majelojde akuta, għalhekk Neupopeg għandu jintuża b 'kawzjoni f' dawn il- pazjenti.