qanastek/EMEA-V3 huggingface dataset:
Neupopeg left at room temperature for more than 72 hours should be discarded.
Neupopeg li tħalla f’ temperatura ambjentali għal aktar minn 72 siegħa għandu ħa
Accidental exposure to freezing temperatures for a single period of less than 24 hours does not adversely affect the stability of Neupopeg.
minn 24 siegħa ma jeffettwax ħażin l- istabilita` ta ’ Neupopeg. li i
Keep the container in the outer carton, in order to protect from light.
Żomm il- kontenitur fil- pakkett ta ’ barra, sabiex tilqa ’ mid- dawl. al in
ed 6.5 Nature and contents of container
6. 5 In- natura tal- kontenitur u ta ’ dak li hemm ġo fih iċ ed
is The syringe inside the pen is made from Type I glass with a rubber stopper, and with a stainless steel
Is- siringa ġewwa il- pinna hija magħmula minn ħġieġ ta ’ tip I, b ’ tapp tal- lastiku, u b’ labra ta ’ azzarr li ma jissaddadx: fiha:
or needle; it contains 0.6 ml of solution for injection.
0. 6 ml ta ’ soluzzjoni għall- injezzjoni.
Pack size of one, for single use only.
Pakkett ta ’ waħda, għall- użu ta ’ darba. tm
th The needle cover of the pre-filled pen contains dry natural rubber (a derivative of latex).
Ara ot
See section
sezzjoni 4. 4. od
6.6 Special precautions for disposal and other handling er ng
6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema u għal immaniġġar ieħor Pr
The carton contains a package leaflet with the full instructions for use and handling. lo
Il- kartuna fiha fuljett ta 'tagħrif bl- istruzzjonijiet kollha għal użu u għal immaniġġar.
Only a o
Qabel l- għoti, is- soluzzjoni Neupopeg trid tiġi spezzjonata bl- għajnejn għall- frak.
solution that is clear and colourless should be injected.
Għandhom jisiru injezzjonijiet biss b’ soluzzjoni li tkun ċara u bla kulur.
Each pen may only be used once. tn uc
Kull pinna tista 'tiġi użata darba biss.
Excessive shaking may aggregate pegfilgrastim, rendering it biologically inactive. od
Taħwid żejjed għandu mnejn jgħaqqad pegfilgrastim u jagħmlu bijoloġikament inattiv.
Allow the pre-filled pen to reach room temperature before injecting. pr
Ħalli l- pinna mimlija għal- lest tilħaq it- temperatura ambjentali qabel ma tinjetta.
Date of first authorisation:
t za Data ta ’ l- ewwel awtorizzazzjoni:
16 July 2007 10.
16 ta ’ Lulju 2007
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/
aw x du Informazzjoni dettaljata dwar dan il- prodott tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar ħa
ed is or th au er ng lo o tn uc od pr al in ic ed M ed is or th au ANNEX II er A.
il- Mediċini (EMEA) http: // www. emea. europa. eu /. ’ g m li i al in iċ ed tm ot od Pr
MANUFACTURER OF THE BIOLOGICAL ACTIVE ng SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE lo o
MANIFATTUR TAS- SUSTANZA BIJOLOĠIKA ATTIVA U ħa
CONDITIONS OF THE MARKETING AUTHORISATION tn uc od pr al in ic ed M A MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
18 A MANIFATTUR TAS- SUSTANZA BIJOLOĠIKA ATTIVA U DETENTUR TA ’ L - AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- HRUĠ TAL - LOTT
ed Puerto Rico 00777-4060 USA
t za Puerto Rico 00777- 4060 L- Istati Uniti
is or Name and address of the manufacturer responsible for batch release
riz to Isem u indirizz tal- manifattur responsabbli għall- ħruġ tal- lott.
th Amgen Europe BV
aw Amgen Europe BV Minervum 7061
au Minervum 7061 NL-4817 ZK Breda The Netherlands
x NL- 4817 ZK Breda L- Olanda
er
du
ng lo
ħa
B CONDITIONS OF THE MARKETING AUTHORISATION o
B KUNDIZZJONIJIET TA 'L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ ’ g
• CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON tn
• m
THE MARKETING AUTHORISATION HOLDER uc
KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FUQ IL- FORNIMENT U L- UŻU IMPOSTI FUQ ID- DETENTUR TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS - li
Summary of Product od
Sommarju tal - Karatteristiċi tal - in
Characteristics, 4.2). pr
Prodott, sezzjoni 4. 2). iċ ed
• CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT al in
MINGĦAJR PERIKLU U EFFETTIV TAL- PRODOTT MEDIĊINALI ot
Not applicable. ic ed M ed is or th au ANNEX III er ng LABELLING AND PACKAGE LEAFLET lo o tn uc od pr al in ic ed M M ed ic in al pr od uc tn o lo A.
19 t za riz to aw x ANNESS III du TIKKETTA U FULJETT TA ’ TAGĦRIF ħa ’ g m li i al in iċ ed tm ot od Pr
LABELLING ng er au th or is ed PARTICULARS TO APPEAR ON THE OUTER PACKAGING
20 Pr od ot tm ed iċ in al
OUTER CARTON
21 m ’ g A.
Neupopeg 6 mg solution for injection Pegfilgrastim
Pegfilgrastim
ed 3.
t za 3.
is or Excipients: sodium acetate, sorbitol (E420), polysorbate 20, water for injections.
riz to Sustanzi mhux attivi: sodium acetate, sorbitol (E420), polysorbate 20 u ilma għall- injezzjoni.
th Excipients known to have a recognised action: sorbitol (E420), sodium acetate.
aw Sustanzi mhux attivi li għandhom azzjoni magħrufa: sorbitol E- 420, sodium acetate.
au See leaflet for further information.
x Ara l- fuljett ta ’ tagħrif għal aktar informazzjoni.
PHARMACEUTICAL FORM AND CONTENTS lo
GĦAMLA FARMAĊEWTIKA U KONTENUT ’ g m
Pack size of one. o tn uc
Soluzzjoni għall- injezzjoni ġo siringa mimlija għal- lest (0. 6ml) Pakkett ta ’ waħda. li i al
METHOD AND ROUTE(S) OF ADMINISTRATION od
MOD TA ’ KIF U MNEJN JINGĦATA in
For subcutaneous use. pr
Użu għal taħt il- ġilda iċ
Read the package leaflet before use. al in
Aqra il- fuljett ta ’ tagħrif qabel l- użu. ed tm
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT ic
TWISSIJA SPEĊJALI LI L- PRODOTT MEDIĊINALI GĦANDU JINŻAMM FEJN MA JINTLAĦAQX U MA JIDHIRX MIT- TFAL ot od
M
Żomm fejn ma jintlaħaqx u ma jidhirx mit- tfal Pr
Dompé Biotec S. p. A.
t za Dompé Biotec S. p. A.
is Italy
riz I- 20122 Milan Italja
or th 12.
to aw 12.
au EU/ 1/ 02/ 228/ 001
x du EU/ 1/ 02/ 228/ 001 ħa ’ g
BATCH NUMBER lo o
NUMRU TAL- LOTT m
Lot: tn uc
Lott: li i al
GENERAL CLASSIFICATION FOR SUPPLY od
KLASSIFIKAZZJONI ĠENERALI TA ’ KIF JINGĦATA in iċ
Medicinal product subject to medical prescription. pr al
Prodott mediċinali jingħata bir- riċetta tat- tabib. ed tm
INSTRUCTIONS ON USE in ic ed
STRUZZJONIJIET DWAR L- UŻU ot od
INFORMATION IN BRAILLE M
INFORMAZZJONI BIL- BRAILLE Pr
Neupopeg MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
Neupopeg
BLISTER PACK WITH SYRINGE
23 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI FOLJA B' SIRINGA ĠO FIHA
Neupopeg 6 mg injection Pegfilgrastim
Neupopeg 6 mg injezzjoni Pegfilgrastim
is or EXP.:
t za EXP:
BATCH NUMBER er Lot: ng lo
aw Lot:
5.
x du ħa 5.
OTHER o tn uc od pr al in ic ed M MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
OĦRAJN ’ g m li i al in iċ ed tm ot od Pr
BLISTERED SYRINGE LABEL
24 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN TIKKETTA TA 'SIRINGA ĠO FOLJA
is EXP.:
riz EXP:
or th 4.
to aw 4.
au Lot: er ng
x Lot: du ħa
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT lo o
IL- KONTENUT SKOND IL- PIŻ, VOLUM, JEW PARTI INDIVIDWALI ’ g m
0.6 ml tn uc
0. 6 ml li i al
OTHER od
OĦRAJN in
Dompé Biotec S. p. A. pr al in ic ed M PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Dompé Biotec S. p. A. iċ ed tm ot od Pr
UNBLISTERED SYRINGE OUTER CARTON
PAKKETT TA ’ BARRA TA 'SIRINGA MHUX ĠO FOLJA
Neupopeg 6 mg solution for injection Pegfilgrastim
Neupopeg 6 mg Soluzzjoni għall- injezzjoni Pegfilgrastim
is or Excipients: sodium acetate, sorbitol (E420), polysorbate 20, water for injections.
riz to Sustanzi mhux attivi: sodium acetate, sorbitol (E420), polysorbate 20, ilma għall- injezzjoni.
Pack size of one. o tn uc
Pakkett ta ’ waħda. li i al
Read the package leaflet before use. al in
Aqra il- fuljett ta ’ tagħrif qabel l- użu ed tm
EXPIRY DATE ic
DATA TA ’ META JISKADI
EXP.: ed M
JIS.:
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE 11.
PREKAWZJONIJIET SPEĊJALI GĦAR- RIMI TA ’ PRODOTTI MEDIĊINALI MHUX UŻATI JEW SKART MINN DAWN IL- PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN
Via San Martino 12 I-20122 Milan Italy
aw x 12.
EU/ 1/ 02/ 228/ 002
NUMRU( I) TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ EU/ 1/ 02/ 228/ 002
BATCH NUMBER
NUMRU TAL- LOTT li
ed Lot:
Lott: i al in
GENERAL CLASSIFICATION FOR SUPPLY
KLASSIFIKAZZJONI ĠENERALI TA ’ KIF JINGĦATA iċ ed
th Medicinal product subject to medical prescription.
Prodott mediċinali jingħata bir- riċetta tat- tabib. tm
INSTRUCTIONS ON USE ng lo
STRUZZJONIJIET DWAR L- UŻU ot od Pr
INFORMATION IN BRAILLE o tn
INFORMAZZJONI BIL- BRAILLE
Neupopeg uc od pr al in ic ed M MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
Neupopeg
UNBLISTERED SYRINGE LABEL
27 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN TIKKETTA TA 'SIRINGA MHUX ĠO FOLJA
Neupopeg 6 mg injection Pegfilgrastim SC
Neupopeg 6 mg injezzjoni Pegfilgrastim SC
OUTER CARTON
28 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA PAKKETT TA ’ BARRA
Neupopeg 6 mg solution for injection in a pre-filled pen Pegfilgrastim
Neupopeg 6 mg soluzzjoni għall- injezzjoni ġo pinna mimlija għal- lest Pegfilgrastim
is or Excipients: sodium acetate, sorbitol (E420), polysorbate 20, water for injections.
riz Sustanzi mhux attivi: sodium acetate, sorbitol (E420), polysorbate 20, ilma għall- injezzjoni
th Excipients known to have a recognised action: sorbitol (E420), sodium acetate.
to Sustanzi mhux attivi li għandhom azzjoni magħrufa: sorbitol E- 420, sodium acetate.
au See leaflet for further information.
aw Ara l- fuljett ta ’ tagħrif għal aktar informazzjoni.
PHARMACEUTICAL FORM AND CONTENTS lo
GĦAMLA FARMAĊEWTIKA U KONTENUT ħa ’ g
Pack size of one. o tn uc
Pakkett ta ’ waħda. m li
METHOD AND ROUTE(S) OF ADMINISTRATION od
MOD TA ’ KIF U MNEJN JINGĦATA i al
For subcutaneous use. pr
Użu għal taħt il- ġilda in
Read the package leaflet before use. al in
Aqra il- fuljett ta ’ tagħrif qabel l- użu iċ ed
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT ic
TWISSIJA SPEĊJALI LI L- PRODOTT MEDIĊINALI GĦANDU JINŻAMM FEJN MA tm
OF THE REACH AND SIGHT OF CHILDREN ed
JINTLAĦAQX U MA JIDHIRX MIT- TFAL ot
M
Żomm fejn ma jintlaħaqx u ma jidhirx mit- tfal od Pr
ed Via San Martino 12 I-20122 Milan
riz Via San Martino 12 I- 20122 Milan
is Italy
to Italja
or th 12.
aw x 12.
au EU/ 1/ 02/ 228/ 003
NUMRU( I) TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ EU/ 1/ 02/ 228/ 003
ng
ħa ’ g m
BATCH NUMBER lo o
NUMRU TAL- LOTT li
Lot: tn uc
Lott: i al in
GENERAL CLASSIFICATION FOR SUPPLY od
KLASSIFIKAZZJONI ĠENERALI TA ’ KIF JINGĦATA iċ ed
Medicinal product subject to medical prescription. pr al
Prodott mediċinali jingħata bir- riċetta tat- tabib. tm
INSTRUCTIONS ON USE in ic ed
STRUZZJONIJIET DWAR L- UŻU ot od Pr
INFORMATION IN BRAILLE M
INFORMAZZJONI BIL- BRAILLE
Neupopeg MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
Neupopeg
PRE-FILLED PEN LABEL
30 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN TIKKETTA TA 'PINNA MIMLIJA GĦAL- LEST
Neupopeg 6 mg injection Pegfilgrastim SC
Pegfilgrastim SC
Dompé Biotec S. p. A. pr al in ic ed M M ed ic in al pr od uc tn o lo ng B.
Dompé Biotec S. p. A. iċ ed tm ot od Pr
PACKAGE LEAFLET er au th or is ed PACKAGE LEAFLET:
FULJETT TA ’ TAGĦRIF du x aw to riz za t FULJETT TA ’ TAGĦRIF:
Neupopeg 6 mg solution for injection in a pre-filled syringe pegfilgrastim
Neupopeg 6 mg soluzzjoni għall- injezzjoni ġo siringa mimlija għal- lest pegfilgrastim
ed In this leaflet
F’ dan il- fuljett:
is 1.
t za 1.
What Neupopeg is and what it is used for
X’ inhu Neupopeg u għalxiex jintuża
or 2.
riz 2.
Before you use Neupopeg 3.
to 3.
th 4.
Kif għandek tuża Neupopeg 4.
au 5.
aw 5.
How to store Neupopeg 6.
Kif taħżen Neupopeg 6.
1.
x du 1.
WHAT NEUPOPEG IS AND WHAT IT IS USED FOR lo
X’ INHU NEUPOPEG U GĦALXIEX JINTUŻA ħa ’ g
Neupopeg is used to reduce the duration of neutropenia (low white blood cell count) and the o
Neupopeg jintuża biex inaqqas id- dewmien ta ’ newtropenja (għadd baxx ta ’ ċelluli bojod fid- demm) u ta ’ newtropenja bid- deni (għadd baxx ta ’ ċelluli bojod fid- demm u deni) li jistgħu jkunu kkawżati m
occurrence of febrile neutropenia (low white blood cell count with a fever) which can be caused by the tn
Iċ- ċelluli bojod tad- demm li
use of cytotoxic chemotherapy (medicines that destroy rapidly growing cells).
huma importanti għaliex jgħinu ‘ l ġismek jiġġieled l- infezzjonijiet.
White blood cells are uc
Dawn iċ- ċelluli huma sensittivi i
If white blood od
ħafna għall- effetti ta ’ kimoterapija li tista ’ tikkawża tnaqqis fin- numru ta ’ dawn iċ- ċelluli f’ ġismek. al
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. pr
Jekk iċ- ċelluli bojod jinżlu għal livell baxx għandu mnejn ma jkunx baqa ’ biżżejjed fil- ġisem biex in
Your doctor has given you Neupopeg to encourage your bone marrow (part of the bone which makes al
jiġġieldu ‘ l batterji u jista ’ jkollok riskju ogħla ta ’ infezzjoni. iċ ed
blood cells) to produce more white blood cells that help your body fight infection. in ic ed
It- tabib tiegħek tak Neupopeg 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. tm ot
BEFORE YOU USE NEUPOPEG M
QABEL MA TUŻA NEUPOPEG od
Do not use Neupopeg
Tużax Neupopeg Pr
• if you are hypersensitive (allergic) to pegfilgrastim, filgrastim, E. coli derived proteins, or any of the other ingredients of Neupopeg.
• jekk tbati minn sensittività eċċessiva (allerġija) għal pegfilgrastim, filgrastim, proteini ġejjin minn E. Coli, jew xi sustanza oħra ta ’ Neupopeg.
Take special care with Neupopeg
Oqgħod attent ħafna b’ Neupopeg
• if you get left upper abdominal pain or pain at the tip of your shoulder. • if you have an allergy to latex.
jekk inti għandek uġigħ addominali fin- naħa ta ’ fuq jew fit- tarf ta ’ l- ispalla. •
Neupopeg has not been tested in pregnant women.
Neupopeg ma ġiex ittestjat f’ nisa tqal.
• think you may be pregnant; or
t taħseb li inti tqila; jew
ed • plan to become pregnant.
riz qed taħseb biex issir tqila.
is or You must stop breast feeding if you use Neupopeg.
to Għandek tieqaf tredda ’ jekk qed tuża Neupopeg.
th au Driving and Using Machines
aw Sewqan u tħaddim ta ’ magni
The effect of Neupopeg on the ability to drive or use machines is not known. er ng Important information about some of the ingredients of Neupopeg lo
x L- effett ta ’ Neupopeg fuq il- kapaċita` li ssuq u li tħaddem magni mhuwiex magħruf. du ħa Tagħarif importanti dwar xi uħud mis- sustanzi ta ’ Neupopeg ’ g
Neupopeg contains sorbitol (a type of sugar).
Neupopeg fih sorbitol (tip ta ’ zokkor).
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Neupopeg.
tipi ta ’ zokkor, ikkuntatja lit- tabib tiegħek qabel ma ’ tieħu Neupopeg.
Neupopeg is essentially o tn
Neupopeg huwa essenzjalment mingħajr sodium. li i al
HOW TO USE NEUPOPEG od
KIF GĦANDEK TUŻA NEUPOPEG in iċ
Neupopeg is for use in adults aged 18 and over. pr al
Neupopeg huwa għall- użu f ’ adulti ta ’ 18- il sena ‘ l fuq. ed
Always take Neupopeg exactly as your doctor has told you.
Dejjem għandek tieħu Neupopeg skond il- parir tat- tabib.
You should check with your doctor or pharmacist if you are unsure.
Dejjem għandek taċċerta ruħek mat- tabib jew tm
skin) using a pre-filled syringe and it should be given approximately 24 hours after your last dose of ic
Id- doża li ssoltu tingħata hija ta ’ injezzjoni taħt il- ġilda b’ siringa mimlija għal- lest ta ’ 6 mg u li għandha tingħata bejn wieħed u ieħor 24 siegħa wara l- aħħar ot
chemotherapy at the end of each chemotherapy cycle. ed
doża ta ’ kimoterapija fi tmiem kull ċiklu ta ’ kimoterapija. od
Injecting Neupopeg yourself
Jekk tinjetta lilek innifsek b’ Neupopeg
Your doctor may decide that it would be more convenient for you to inject Neupopeg yourself.
It- tabib jista ’ jiddeċiedi li jkun aħjar għalik jekk tinjetta lilek innifsek b ’ Neupopeg.
For further instructions on how to inject yourself with Neupopeg, please read the section at the end of this leaflet.
Għal aktar istruzzjonijiet dwar kif tinjetta lilek innifsek b’ Neupopeg, jekk jogħġbok aqra s- sezzjoni fi tmiem dan il- fuljett.
If you use more Neupopeg than you should
Jekk tuża Neupopeg aktar milli suppost
If you use more Neupopeg than you should contact your doctor, nurse or pharmacist.
Jekk tuża Neupopeg aktar milli suppost, għandek tgħarraf lit- tabib, l- infermiera jew l- ispiżjar tiegħek.
If you forget to inject Neupopeg
34 Jekk tinsa tieħu Neupopeg:
If you have forgotten a dose of Neupopeg, you should contact your doctor to discuss when you should inject the next dose.
Jekk tinsa tieħu d- doża ta ’ Neupopeg, kellem lit- tabib tiegħek biex jara meta jmissek tinjetta d- doża li jmiss.
Like all medicines, Neupopeg can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Neupopeg jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
An uncommon side effect (likely to occur in fewer than 1 in 100 patients) is nausea.
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 -
ed Allergic-type reactions to Neupopeg, including redness and flushing, skin rash, raised areas of the skin
Effett sekondarju ieħor li mhux komuni (li hemm ċans li jseħħu f ’ anqas minn pazjent 1 f ’ kull 100 pazjent) huwa d- dardir.
is that itch and anaphylaxis (weakness, drop in blood pressure, difficulty breathing, swelling of the face),
riz to Reazzjonijiet ta ’ allerġija għal Neupopeg, 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
or have rarely (likely to occur in fewer than 1 in 1000 patients) been reported.
aw tieħu n- nifs, nefħa fil- wiċċ), ġew irrappurtati f’ każijiet rari (hemm ċans li jseħħu f ’ anqas minn pazjent 1 f ’ kull 1000 pazjent)..
th Increased spleen size and very rare cases (likely to occur in fewer than 1 in 10,000 patients)) of spleen
Ftit każijiet ta 'milza ħa
au rupture have been reported after the use of Neupopeg.
mifqugħha kienu fatali. ’ g
Some cases of splenic rupture were fatal. er It is important that you contact your doctor immediately if you experience pain in the upper left side of ng the abdomen or left shoulder pain since this may relate to a problem with your spleen. lo
Huwa importanti li tgħarraf lit- tabib tiegħek immedjatament jekk jkollok uġigħ fin- naħa ta 'fuq fix - m
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 in
If you have a cough, fever and difficulty breathing please tell your doctor. o tn
tieħu n- nifs ġew irrappurtati wara li ttieħdu fatturi li jistimolaw l- kolonji ta ’ granuloċiti (G- CSFs). iċ
Some changes may occur in your blood, but these will be detected by routine blood tests.
Jekk taqbdek is- sogħla, jitlagħlek id- deni jew ikollok problemi biex tieħu n- nifs għarraf lit- tabib ed
Your uc
tiegħek. tm
platelet count may become low which might result in bruising.
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 white blood cell count may become high for a short period of time. od
L- għadd ta 'ot
Sweet’ s syndrome (plum-coloured, raised, painful lesions on the limbs and sometimes the face and pr
ċelluli bojod jista 'jogħla għal- tul ta' żmien qasir. od
neck with fever) has occurred very rarely (likely to occur in fewer than 1 in 1,000 patients) but other factors may play a role. al in
Seħħ rarament (li hemm ċans li jseħħu f ’ anqas minn pazjent 1 f ’ kull 1, 000 pazjent) s- sindromu ta 'Pr
Very rarely (likely to occur in fewer than 1 in 10,000 patients) cutaneous vasculitis (inflammation of ic
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.
the blood vessels in the skin) has occurred in patients receiving Neupopeg. ed
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 Neupopeg.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please M
Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek.
HOW TO STORE NEUPOPEG
KIF TAĦŻEN NEUPOPEG
Do not use Neupopeg after the expiry date which is stated on the box and on the syringe label (EXP).
35 Tużax Neupopeg wara d- data ta ’ skadenza li tidher fuq il- kaxxa u fuq it- tikketta tas- siringa (JIS).
You may take Neupopeg out of the refrigerator and keep it at room temperature (not above 30°C) for no longer than 3 days.
Tista ’ toħroġ Neupopeg mill- friġġ u żżommu f’ temperatura ambjentali (mhux aktar minn 30°C) għal mhux aktar minn 3 ijiem.
Neupopeg may be used if it is accidentally frozen for a single period of less than 24 hours.
Neupopeg jista ’ jintuża jekk jiġi ffriżat bi żball għal perjodu wieħed ta ’ inqas minn 24 siegħa.
Do not use Neupopeg if you notice it is cloudy or there are particles in it.
Tużax Neupopeg jekk tinnota li huwa imdardar jew jekk tara xi frak ġo fih.
Medicines should not be disposed of via wastewater or household waste.
t za Il- mediċini m’ għandhomx jintremew ma ’ l- ilma tad- dranaġġ jew ma ’ l- iskart domestiku.
These measures will help to protect the environment.
riz protezzjoni ta ’ l- ambjent.
6.
to aw 6.
What Neupopeg contains
x X’ fih Neupopeg Neupopeg fih is- sustanza attiva pegfilgrastim.
ed Neupopeg contains the active substance pegfilgrastim.
du huwa proteina magħmula mill -
Pegfilgrastim is a protein produced by biotechnology in bacteria called E. coli.
Coli.
It belongs to a group of proteins called cytokines, and is very
Huwa parti minn grupp ta ’ proteini msejħa ċitokini, u ’ g
is similar to a natural protein (granulocyte-colony stimulating factor) produced by your own body.
jixbaħ ħafna lill- proteina naturali (fattur li jistimola l- kolonji ta ’ granuloċiti) li hija prodotta mill- ġisem tiegħek. m li
or The active substance is pegfilgrastim.
Is- sustanza attiva hi pegfilgrastim.
Each pre-filled syringe contains 6 mg of pegfilgrastim in 0.6 ml
Kull siringa mimlija għal- lest fiha 6 mg ta ’ pegfilgrastim f ’ i
th of solution.
soluzzjoni ta ’ 0. 6 ml. al in
au The other ingredients are sodium acetate, sorbitol (E420), polysorbate 20 and water for injections. er ng What Neupopeg looks like and contents of the pack lo
Is- sustanzi l- oħra huma sodium acetate, sorbitol (E420), polysorbate 20 u ilma għall- injezzjoni. iċ ed
Neupopeg is a solution for injection in a pre-filled syringe (6 mg/ 0.6 ml). o
Id- Dehra tal- prodott u d- daqs tal- pakkett: tm
Each pack contains 1 pre-filled syringe.
Neupopeg huwa soluzzjoni għall- injezzjoni ġo siringa mimlija għal- lest (6 mg / 0. 6ml).
The syringes are provided either with or without a blister tn
Is- siringi jinstabu ġo folja jew mingħajr folja. ot
It is a clear, colourless liquid. uc
Neupopeg huwa likwidu ċar mingħajr kulur. od
Manufacturer: od
Pr
Minervum 7061 pr
Minervum 7061 4817 ZK Breda L- Olanda
Marketing Authorisation Holder: ic
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- suq:
Via San Martino 12 I-20122 Milan M
Via San Martino 12 I- 20122 Milan Italja
If you want more information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq.
This leaflet was last approved.
36 Dan il- fuljett kien approvat l- aħħar f ’.
--------------------------------------------------------------------------------------------------------------------------- Instructions for injecting with the Neupopeg pre-filled syringe
Tagħrif dwar kif tinjetta lilek innifsek b' siringa mimlija għal- lest b' Neupopeg
This section contains information on how to give yourself an injection of Neupopeg.
Din il- parti tal- fuljett tinkludi tagħrif dwar kif tagħti injezzjoni ta ’ Neupopeg lilek innifsek.
How do you, or the person injecting you, use Neupopeg pre-filled syringe?
t Kif inti, jew il- persuna li se tinjettak, tuża is- siringa mimlija għal- lest b' Neupopeg?
You will need to give yourself the injection into the tissue just under the skin.
za Ikollok bżonn tagħti injezzjoni lilek innifsek eżatt taħt il- ġilda.
Equipment that you need
riz to Apparat li teħtieġ
To give yourself a subcutaneous injection you will need:
aw Biex tagħti injezzjoni taħt il- ġilda lilek innifsek teħtieġ:
ed • a pre-filled syringe of Neupopeg; and
x siringa mimlija għal- lest b’ Neupopeg; u ● du ħa msielaħ ta’ l- alkoħol jew simili; ● ’ g
or th What should I do before I give myself a subcutaneous injection of Neupopeg?
X’ għandi nagħmel qabel ma ninjetta lili nnifsi taħt il- ġilda b’ Neupopeg? m
Remove from the refrigerator.
Oħroġ s- siringa mimlija għal- lest b’ Neupopeg mill- friġġ. li i al
Do not shake the pre-filled syringe. er ng
Tħawwadx is- siringa mimlija għal- lest. in
Do not remove the cover from the syringe until you are ready to inject. lo
Tneħħix l- għatu tas- siringa qabel ma tkun lest biex tinjetta. iċ ed
Do not use it if the date has passed o
Tużax jekk id- data qabżet l- aħħar ġurnata tax- xahar muri. tm
Check the appearance of Neupopeg.
Iċċekkja d- dehra ta ’ Neupopeg.
It must be a clear and colourless liquid.
Jekk ot
If there are particles in it, you must not use it. od
ikun fiha xi frak, m’ għandekx tużha. od
For a more comfortable injection, let the pre-filled syringe stand for 30 minutes to reach room pr
Għal injezzjoni aktar komda, ħalli is- siringa mimlija għal- lest toqgħod għal 30 minuta Pr
Do not warm al
sabiex tilħaq temperatura ambjentali, jew żomm is- siringa mimlija għal- lest delikatament f’ idejk għal ftit minuti.
Neupopeg in any other way (for example, do not warm it in a microwave or in hot water). in
Issaħħanx Neupopeg bl’ ebda mod ieħor (eżempju: issaħħanx fil - forn li jsaħħan l- ikel aktar malajr bil- majkrowejv jew f’ ilma jaħraq).
Wash your hands thoroughly. ic ed
Aħsel idejk sew.
M
Sib post komdu, mdawwal sew, naddaf il- wiċċ, u poġġi dak kollu li għandek bżonn fejn tista 'tilħaqhom.
How do I prepare my Neupopeg injection?
37 Kif nipprepara l- injezzjoni ta ’ Neupopeg?
Before you inject Neupopeg you must do the following:
Qabel ma tinjetta Neupopeg trid tagħmel dan li ġej:
You do not have to remove the air bubble before injecting.
M' hemmx bżonn tneħħi il- bużżieqa ta 'l- arja qabel ma tinjetta.
Where should I give my injection?
t za Fejn għandi nagħti l- injezzjoni lili nnifsi?
The most suitable places to inject yourself are:
riz L- aħjar postijiet fejn tinjetta lilek innifsek huma:
the top of your thighs; and the abdomen, except for the area around the navel.
in- naħa ta ’ fuq ta ’ kuxxtejk; u
If someone else is injecting you, they can also use the back of your arms.
l- addome, minbarra l- parti ta 'madwar iż- żokkra.
How do I give my injection?
x Jekk xi ħadd ieħor qed jinjettak, jista ’ wkoll juża in- naħa ta ’ wara ta ’ idejk. du ħa Kif nagħti l- injezzjoni? ’ g
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 m
Put the ne edle fully into the skin as shown by your nurse or doctor.
Daħħal il- labra għal kollox fil- ġilda kif wrewk l- infermiera jew it- tabib tiegħek. i al
If you see
Iġbed il- planġer tas- siringa kemm kemm sabiex tara li ma ttaqbitx xi vina jew arterja. in
is blood in the syringe, remove the needle and re-insert it in another place.
Jekk tara d- demm fis- siringa, neħħi l- labra u erġa 'daħħalha f’ post ieħor. iċ ed
Inject the liquid slowly and evenly, always keeping your skin pinched.
Injetta l- likwidu bil- mod u bl- istess ritmu, filwaqt li dejjem iżżomm il- ġilda maqrusa. tm
After injecting the liquid, remove the needle and let go of your skin.
Wara li tinjetta l- likwidu, neħħi l- labra u itlaq il- ġilda. ot
6. er 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. od
Do not ng rub the injection site.
Togħrokx il- post ta 'l- injezzjoni.
If needed, you may cover the injection site with a bandage. lo
Pr
Do not use any Neupopeg that is left in the syringe. o tn
M’ għandekx tuża xi Neupopeg li jkun baqa ’ fis - siringa.
Remember uc
Ftakar
If you have any problems, please do not be afraid to ask your doctor or nurse for help and advice. od
Jekk għandek xi problemi, jekk jogħġbok tibżax issaqsi lit- tabib jew lill- infermiera tiegħek għal għajnuna jew parir.
Disposing of used syringes pr
Rimi ta ’ siringi użati
• Do not put the cover back on used needles. al
Terġax tqiegħed l- għatu fuq labar użati. ●
• Keep used syringes out of the reach and sight of children. in ic
Żommu siringi użati ‘ l bogħod minn fejn jistgħu jilħquhom jew jarawhom it- tfal. ●
Ask your ed
38 Is- siringi użati għandhom jintremew kif jitolbu l- liġijiet lokali.
pharmacist how to dispose of medicines no longer required.
Staqsi lill- ispiżjar dwar kif ● għandek tarmi mediċini li m’ għandekx bżonn.
M PACKAGE LEAFLET:
t za riz to aw x du ħa ’ g m li i al in iċ ed tm ot od Pr
INFORMATION FOR THE USER
39 FULJETT TA ’ TAGĦRIF:
Neupopeg 6 mg solution for injection in a pre-filled pen pegfilgrastim
Neupopeg 6 mg soluzzjoni għall- injezzjoni ġo pinna mimlija għal- lest pegfilgrastim
ed 1.
t za 1.
is 2.
riz 2.
Bef ore you use Neupopeg
Qabel ma tuża Neupopeg
How to use Neupopeg 4.
Kif għandek tuża Neupopeg 4.
th 5.
aw 5.
au 6.
Kif taħżen Neupopeg 6.
Further information er ng 1.
x du 1.
Neupopeg is used to reduce the duration of neutropenia (low white blood cell count) and the occurrence of febrile neutropenia (low white blood cell count with a fever) which can be caused by the o
Neupopeg jintuża biex inaqqas id- dewmien ta ’ newtropenja (għadd baxx ta ’ ċelluli bojod fid- demm) u ta ’ newtropenja bid- deni (għadd baxx ta ’ ċelluli bojod fid- demm u deni) li jistgħu jkunu kkawżati m
use of cytotoxic chemotherapy (medicines that destroy rapidly growing cells).
minn kimoterapija ċitotossika (mediċini li jeqirdu ċ- ċelluli li jikbru malajr).
White blood cells are tn
Iċ- ċelluli bojod tad - li
important as they help your body fight infection.
demm huma importanti għaliex jgħinu ‘ l ġismek jiġġieled l- infezzjonijiet.
These cells are very sensitive to the effects of uc
Dawn iċ- ċelluli huma i
chemotherapy which can cause the number of these cells in your body to decrease.
sensittivi ħafna għall- effetti ta ’ kimoterapija li tista ’ tikkawża tnaqqis fin- numru ta ’ dawn iċ- ċelluli al
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 od
Jekk iċ- ċelluli bojod jinżlu għal livell baxx għandu mnejn ma jkunx baqa ’ biżżejjed fil - in
increased risk of infection. pr
ġisem biex jiġġieldu ‘ l batterji u jista ’ jkollok riskju ogħla ta ’ infezzjoni. iċ ed
Your doctor has given you Neupopeg 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. al in ic
It- tabib tiegħek tak Neupopeg 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. tm ot
BEFORE YOU USE NEUPOPEG ed
QABEL MA TUŻA NEUPOPEG od
Do not use Neupopeg M
Tużax Neupopeg Pr
• think you may be pregnant; or
t • taħseb li inti tqila; jew
ed • plan to become pregnant.
za riz • qed taħseb biex issir tqila
HOW TO USE NEUPOPEG od
KIF GĦANDEK TUŻA NEUPOPEG (SURECLICK) in iċ
You should check with your doctor or pharmacist if you are unsure.
Dejjem għandek taċċerta ruħek mat- tabib tm
skin) using a pre-filled syringe and it should be given approximately 24 hours after your last dose of ic
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 - ot
chemotherapy at the end of each chemotherapy cycle. ed
aħħar doża ta ’ kimoterapija fi tmiem kull ċiklu ta ’ kimoterapija. od
Your doctor has decided it would be best f or you to inject Neupopeg yourself.
It- tabib jista ’ jiddeċiedi li jkun aħjar għalik jekk tinjetta lilek innifsek b ’ Neupopeg.
If you forget to inject Neupopeg
41 Jekk tinsa tieħu Neupopeg:
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
An uncommon side effect (likely to occur in fewer than 1 in 100 patients) is nausea.
riz ċans li jseħħu f ’ anqas minn pazjent 1 f ’ kull 100 pazjent) huwa d- dardir.
ed Allergic-type reactions to Neupopeg, including redness and flushing, skin rash, ra ised areas of the skin
to Reazzjonijiet ta ’ allerġija għal Neupopeg, inklużi ħmura u fwawar, raxx tal- ġilda, partijiet tal- ġilda
is that itch and anaphylaxis (weakness, drop in blood pressure, difficulty breathing, swelling of the face),
aw 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
or have rarely (likely to occur in fewer than 1 in 1000 patients) been reported.
x pazjent 1 f ’ kull 1000 pazjent)
th Increased spleen size and very rare cases (likely to occur in fewer than 1 in 10,000 patients)) of spleen
Ftit każijiet ta 'milza ’ g
au rupture have been reported after the use of Neupopeg.
mifqugħha kienu fatali. m
Some cases of splenic rupture were fatal. er It is important that you contact your doctor immediately if you experience pain in the upper left side of ng the abdomen or left shoulder pain since this may relate to a problem with your spleen. lo
Huwa importanti li tgħarraf lit- tabib tiegħek immedjatament jekk jkollok uġigħ fin- naħa ta 'fuq fix - li
Rare (likely to occur in fewer than 1 in 1000 patients)cases of breathing problems have been reported after taking G-CSFs.
xellug ta 'l- addome jew jkollok uġigħ fl- ispalla xellugija, peress li dan jista' jkun relatat ma 'problema i
If you have a cough, fever and difficulty breathing please tell your doctor. o tn
fil- milza tiegħek. al in
Your uc
Każijiet rari (li hemm ċans li jseħħu f ’ anqas minn pazjent 1 f ’ kull 1000 pazjent) ta 'problemi biex iċ
Your white blood cell count may become high for a short period of time. od
tieħu n- nifs ġew irrappurtati wara li ttieħdu fatturi li jistimolaw l- kolonji ta ’ granuloċiti (G- CSFs). ed
Sweet’s syndrome (plum-coloured, raised, painful lesions on the limbs and sometimes the face and pr
Jekk taqbdek is- sogħla, jitlagħlek id- deni jew ikollok problemi biex tieħu n- nifs għarraf lit- tabib tiegħek. tm
neck with fever) has occurred very rarely (likely to occur in fewer than 1 in 10,000 patients) but other factors may play a role. al in
Jista 'jkun hemm ftit tibdil fid- demm tiegħek, imma dan it- tibdil se joħrog fir- riżultat tat- testijiet tad - ot
Very rarely (likely to occur in fewer than 1 in 10,000 patients) cutaneous vasculitis (inflammation of ic
L- għadd ta 'ċelluli bojod jista' jogħla għal- tul ta 'żmien qasir. od Pr
the blood vessels in the skin) has occurred in patients receiving Neupopeg. ed
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.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please M
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 Neupopeg.
tell your doctor or pharmacist.
Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek.
Do not use Neupopeg after the expiry date which is stated on the box and on the pen label (EXP).
42 Tużax Neupopeg wara d- data ta ’ skadenza li tidher fuq il- kaxxa u fuq it- tikketta tal- pinna (JIS/ EXP).
Neupopeg may be used if it is accidentally frozen for a single period of less than 24 hours.
Neupopeg jista ’ jintuża jekk jiġi ffriżat bi żball għal perjodu wieħed ta ’ inqas minn 24 siegħa
Neupopeg contains the active substance pegfilgrastim.
x Neupopeg fih is- sustanza attiva pegfilgrastim.
Pegfilgrastim is a protein produced by biotechnology in bacteria called E. coli.
Pegfilgrastim huwa proteina magħmula mill - du bijoteknoloġija f’ batterji li jissejħu E.
It belongs to a group of proteins call ed cytokines, and is very
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 - ħa
ed similar to a natural protein (granulocyte-colony stimulating factor) produced by your own body.
ġisem tiegħek. ’ g
is What Neupopeg contains
X’ fih Neupopeg m li
Each pre-filled pen contains 6 mg of pegfilgrastim in 0.6 ml of
Kull pinna mimlija għal- lest fiha 6 mg ta ’ pegfilgrastim f ’ i
th solution.
soluzzjoni ta ’ 0. 6 ml. al in
Neupopeg is a solution for injection in a pre-filled pen (6 mg/0.6 ml). o
Id- Dehra tal- prodott u d- daqs tal- pakkett: tm
Each pack contains 1 pre-filled pen.
Neupopeg huwa soluzzjoni għall- injezzjoni ġo pinna mimlija għal- lest (6 mg / 0. 6ml).
It is a clear, colourless liquid. tn uc
Neupopeg huwa likwidu ċar mingħajr kulur. ot
Manufacturer:
Il- Manifattur: od
Amgen Europe B.V. od
Pr
Minervum 7061 4817 ZK Breda pr
Minervum 7061 4817 ZK Breda L- Olanda
Marketing Authorisation Holder: in
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- suq:
Via San Martino 12 ed
Via San Martino 12 I- 20122 Milan Italja
If you want more information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- suq.
This leaflet was last approved.
43 Dan il- fuljett kien approvat l- aħħar f ’.
--------------------------------------------------------------------------------------------------------------------------- Instructions for injecting with the Neupopeg pre-filled pen (SureClick)
Tagħrif dwar kif tinjetta lilek innifsek b' pinna mimlija għal- lest b' Neupopeg (SureClick)
This section contains information on how to properly use the Neupopeg pre-filled pen.
Din il- parti tal- fuljett tinkludi tagħrif dwar kif tuża sew il- pinna mimlija għal- lest b' Neupopeg.
How do you, or the person injecting you, use Neupopeg pre-filled pen (SureClick)?
Kif inti, jew il- persuna li se tinjettak, tuża il- pinna mimlija għal- lest b' Neupopeg (SureClick)?
You will need to give yourself the injection into the tissue just under the skin.
t Ikollok bżonn tagħti injezzjoni lilek innifsek eżatt taħt il- ġilda.
Equipment:
za Apparat:
To give yourself a subcutaneous injection you will ne ed:
riz to Biex tagħti injezzjoni taħt il- ġilda lilek innifsek teħtieġ:
ed • a new Neupopeg pre-filled pen and
aw pinna ġdida mimlija għal- lest b’ Neupopeg; u ●
th Preparing for a Neupopeg injection?
x msielaħ ta’ l- alkoħol jew simili; ● du ħa Tipprepara għall- injezzjoni b 'Neupopeg? ’ g
Remove from the refrig erator.
Oħroġ il- pinna mimlija għal- lest mill- friġġ. m
Do not shake the pre-filled pen. lo
Tħawwadx il- pinna mimlija għal- lest. i al
Do not remove the grey needle shield from the pre-filled pen until you are ready to inject. o
Tneħħix l- għatu griż tal- labra tal- pinna mimlija għal- lest qabel ma tkun lest biex tinjetta. in
Do not use it if the date has passed the tn
Tużax jekk id- data iċ
last day of the month shown uc
qabżet l- aħħar ġurnata tax- xahar muri. ed
Check the appearance of Neupopeg through the inspection window.
Iċċekkja d- dehra ta ’ Neupopeg minn ġo t- tieqa għal ispezzjoni.
It must be a clear and od
Il- likwidu għandu jkun ċar u tm
colourless liquid.
mingħajr kulur.
If there are particles in it, you must not use it. pr
Jekk ikun fiha xi frak, m’ għandekx tużha. ot
Do al
injezzjoni aktar komda, ħalli il- pinna mimlija għal- lest toqgħod għal 30 minuta od
not warm Neupopeg in any other way (for example, do not warm it in a microwave or in hot water). in ic
Pr
Wash your hands thoroughly. ed
Aħsel idejk sew.
M
Tieqa għal ispezzjoni
Before use (with grey needle shield)
44 Qabel l- użu (bl- għatu ta 'sigurtà griż tal- labra)
To perform a successful injection a firm injection area is requir ed.
t za Biex tinjetta lilek nnifsek sew għandek issib parti soda fejn tinjetta.
ed The recommended sites for injection using the pre-filled pen are the
riz Il- partijiet rakkomandati għal injezzjoni b' pinna mimlija għal- lest
is top of the thigh and the back of the arm if given by a nurse or carer
to huma in- naħa ta ’ fuq ta ’ kuxxtejk u in- naħa ta ’ wara ta ’ idejk jekk l -
th The abdomen can be considered when the thigh and back of arm are
aw injezzjoni tingħata minn infermiera jew carer (ara stampa 1).
au judged by a healthcare professional to be inappropriate.
x du ħa
How to give an injection into the thigh or back of the arm
Kif nagħti l- injezzjoni fil- koxxa jew fin- n- naħa ta ’ wara ta’ l- id ’ g m
er
• Iddisinfetta l- ġilda billi tuża msielaħ ta’ l- akoħol.
2.
2. li
ng
• Neħħi l- għatu griż tal- labra (ara Stampa 2). i al in
• Disinfect your skin by using an alcohol wipe. lo
• Il- pinna mimlija għal- lest għandha għatu ta 'sigurtà li iċ
• Remove the grey needle shield (see picture 2). o tn
jipproteġik minn tingiż bil- labra jew minn telfien tal- mediċina jekk titmiss jew titħabbat il- labra bi żball. ed tm ot od
touching. pr
Pr
Important information for Step A of the injecting process. al
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). in
Agħfas il- pinna mimlija għal- lest b' mod sod mal- ġilda biżżejjed sabiex l- għatu ta 'sigurtà jidħol' l ġewwa kompletament (ara stampa
ed
Għatu ta 'out
ic
fully retracted
out
sigurtà barra
At start, keep thumb clear of green button M
45 Fil- bidu, keep thumb clear of At start, żżommx sebgħek il- kbir fuq il- buttuna ħadra green button
2 release
2 itlaq Klik
1 press B.
t za 1għafas 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
release the green button on top.
Għandek
You will hear a “click”.
to tisma 'ħoss ta' “ klik ”.
B.
aw x du ħa
C.
Klik ’ g m li
After the second “click” (or count of 15) lift pre-fill ed pen
Wara t- tieni ħoss ta '“ klik ” (jew għodd sa 15) għolli l- pinna i al
ed from the injection site.
C. mimlija għal- lest mill- post ta 'l- injezzjoni. in iċ ed tm ot od
is or th If you experience difficulties choose a more firm injection site.
Pr
au 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 er will be green, confirming the injection is complete. ng
It- tieqa għal ispezzjoni tkun ħadra, b' hekk tikkonferma li l- injezzjoni hija kompluta.
Do not rub the lo
Jekk tinnota xi qatra demm fil- post ta 'l- injezzjoni imsaħha b' biċċa tajjar jew tixxu.
injection site.
Togħrokx il- post ta 'l- injezzjoni.
If needed, you may cover the injection site with a bandage. o tn
Jekk hemm bżonn, tista 'tgħatti l- post ta' l- injezzjoni b' faxxa.
Only use a single Neupopeg pre-filled pen for each injection. uc
Uża pinna mimlija għal- lest ta 'Neupopeg waħda għal kull injezzjoni.
Important skin pinch technique pr
Agħzel post mill- anqas 5cm 'il bogħod miż- żokkra (ara stampa 4).
The objective of the skin pinch technique is to create a firm site for the al
Oqros b' mod sod il- ġilda ta 'l- addome bejn sebgħek il- kbir u subgħajk biex toħloq spazju ta' mill- anqas 3cm (darbtejn il- wisa 'tal- ponta tal - pinna mimlija għal- lest).
Choose a site at least 5 cm away from the belly button (navel) (see ic
Żomm sod il- ġilda maqrusa tul il- proċess kollu (ara stampa 5).
Pinch the skin of the abdomen firmly between the thumb and fingers M
6.
creating a space at least 3 cm wide (twice the width of the tip of the pre-filled pen).
t za riz 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).
aw Għafas 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 sticks or loss of drug by accidental bumping or touching.
x du ħa Għatu ta 'sigurtà Għatu ta' Il- pinna mimlija għal- lest għandha għatu ta 'sigurtà li jipproteġik minn ’ g
Safety cover
mdaħħal 'l ġewwa
fully retracted At start, keep thumb clear of green button
tingiż bil- labra jew minn telfien tal- mediċina jekk titmiss jew titħabbat il- labra bi żball. m li i
A.
buttuna ħadra A.
Centre the pre-filled pen in the area of the pinched skin at a right angle (90 degrees) and push firmly against the skin.
Iċentra l- pinna mimlija għal- lest fuq il- ġilda maqrusa b 'angolu iċ
Hold down.
Żomm 'l isfel ed tm ot
B.
Pr
ed is or C.
1 għafas
After the second “click” (or a count of 15) lift the pre-filled
B.
th 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.
au er If you experience difficulties choose a more firm injection site. ng
Jekk tesperjenza xi diffikultajiet għażel post aktar sod għall- injezzjoni.
The inspection window lo
47 L- għatu ta 'sigurtà tal- labra jinżel' l isfel għal fuq il- labra u jorbot f' postu.
will be green, confirming the injection is complete. o tn
It- tieqa għal ispezzjoni tkun ħadra, b' hekk tikkonferma li l- injezzjoni hija kompluta.
If needed, you may cover the injection site with a bandage. uc
Jekk hemm bżonn, tista 'tgħatti l- post ta' l- injezzjoni b' faxxa.
Only use a single Neupopeg pre-filled pen for each injection. od pr
Uża pinna mimlija għal- lest b' Neupopeg waħda għal kull injezzjoni.
Remember al
Ftakar
If you have any problems, please do not be afraid to ask your doctor or nurse for help and advice. in ic
Jekk għandek xi problemi, jekk jogħġbok tibżax issaqsi lit- tabib jew lill- infermiera tiegħek għal għajnuna jew parir.
Disposing of used pre-filled pens ed
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 M
t za Minħabba l- għatu ta 'sigurtà mhux rakkomandat li terġa' tqiegħed l- għatu griż tal- labra fuq il - ● pinna mimlija għal- lest użata.
the used pre-filled pen.
riz to Żommu pinnen użati ‘ l bogħod minn fejn jistgħu jilħquhom jew jarawhom it- tfal. ●
• Keep used pens out of the reach and sight of children.
Staqsi lill - ● ispiżjar dwar kif għandek tarmi mediċini li m’ għankekx bżonn.
Ask your pharmacist how to dispose of medicines no longer required.
protezzjoni ta ’ l- ambjent.
These measures will help to protect the environment
ħa ’ g m li i al in iċ ed tm ot od Pr
What is Neupro?
X' inhu Neupro?
Neupro is a range of transdermal patches (patches that deliver a medicine across the skin).
Neupro huwa firxa ta 'stikks transdermiċi (dan ifisser li l- mediċina tingħata minn ġol- ġilda).
Each patch releases 1, 2, 3, 4, 6 or 8 mg of the active substance rotigotine over 24 hours.
Kull stikk jerħi 1, 2, 3, 4, 6 jew 8 mg tas- sustanza attiva rotigotina (rotigotine) f' 24 siegħa.
What is Neupro used for?
Għal xiex jintuża Neupro?