qanastek/EMEA-V3 huggingface dataset:
1 pre-filled syringe contains 135 micrograms of peginterferon alfa – 2a.
Siringa 1 mimlija għal- lest fiha 135 mikrogramma ta ’ peginterferon alfa- 2a
Also contains sodium chloride, polysorbate 80, benzyl alcohol (see the package leaflet for futher information), sodium acetate, acetic acid and water for injections.
Fih ukoll sodium chloride, polisorbate 80, benzyl alcohol (għal aktar informazzjoni ara l- fuljett ta ’ tagħrif), sodium acetate, acetic acid u ilma għall- injezzjonijiet.
4 pre-filled syringes + 4 injection needles 135 micrograms in 0.5 ml
4 Siringi mimlijin għal- lest + 4 labar għall- injezzjoni 135 mikrogramma f’ 0. 5 ml
123 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
123 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
OUTER CARTON – 12 x 135 μ g PRE-FILLED SYRINGES
PAKKETT TA ’ BARRA – 12- IL SIRINGA MIMLIJA GĦAL- LEST x 135 μg
1 pre-filled syringe contains 135 micrograms of peginterferon alfa – 2a.
Siringa 1 mimlija għal - lest fiha 135 mikrogramma ta ’ peginterferon alfa- 2a
12 pre-filled syringes + 12 injection needles 135 micrograms in 0.5 ml
12- il siringa mimlija għal - lest + 12- il labra għall- injezzjoni 135 mikrogramma f’ 0. 5 ml
Subcutaneous use Read the package leaflet before use
Użu għal taħt il- ġilda Aqra il- fuljett ta ’ tagħrif qabel l- użu
125 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
125 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI IŻ- ŻGĦAR EWLENIN
135 μ g PRE-FILLED SYRINGE
135 μg SIRINGA MIMLIJA GĦAL- LEST
135 μ g in 0.5 ml
135 μg f’ 0. 5 ml
126 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
126 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
OUTER CARTON – 1 x 180 μ g PRE-FILLED SYRINGE
PAKKETT TA ’ BARRA – 1 x 180 μg SIRINGA MIMLIJA GĦAL- LEST
Pegasys 180 micrograms solution for injection in pre-filled syringe Peginterferon alfa-2a
Pegasys 180 mikrogramma f’ soluzzjoni għall- injezzjoni ġo siringa mimlija għal- lest Peginterferon alfa- 2a
1 pre-filled syringe contains 180 micrograms of peginterferon alfa -2a.
Siringa mimlija għal- lest 1 fiha 180 mikrogramma ta ’ peginterferon alfa- 2a
1 pre-filled syringe + 1 injection needle 180 micrograms in 0.5 ml
Siringa mimlija għal- lest 1+ labra 1 għall- injezzjoni 180 mikrogramma f’ 0. 5 ml
128 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
128 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
OUTER CARTON – 4 x 180 μ g PRE-FILLED SYRINGE
PAKKETT TA ’ BARRA – 4 SIRINGI MIMLIJIN GĦAL- LEST x 180 μg
Pegasys 180 micrograms solution for injection in pre-filled syringe Peginterferon alfa-2a
Pegasys 180 mikrogramma f’ soluzzjoni għall- injezzjoni ġo siringa mimlija għal - lest Peginterferon alfa- 2a
1 pre-filled syringe contains 180 micrograms of peginterferon alfa – 2a.
Siringa 1 mimlija għal - lest fiha 180 mikrogramma ta ’ peginterferon alfa- 2a
4 pre-filled syringes + 4 injection needles 180 micrograms in 0.5 ml
4 Siringi mimlijin għal - lest + 4 labar għall- injezzjoni 180 mikrogramma f’ 0. 5 ml
Store in a refrigerator Do not freeze Keep the pre-filled syringe in the outer carton in order to protect from light
Aħżen fi friġġ Tagħmlux fil- friża Żomm is- siringa mimlija għal - lest fil- kartuna ta ’ barra sabiex tilqa ’ mid- dawl
130 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
130 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
OUTER CARTON – 12 x 180 μ g PRE-FILLED SYRINGE
PAKKETT TA ’ BARRA – 12- IL SIRINGA MIMLIJA GĦAL- LEST x 180 μg
1 pre-filled syringe contains 180 micrograms of peginterferon alfa – 2a.
Siringa 1 mimlija għal- lest fiha 180 mikrogramma ta ’ peginterferon alfa- 2a
12 pre-filled syringes + 12 injection needles 180 micrograms in 0.5 ml
12- il siringa mimlija għal - lest + 12- il labra għall- injezzjoni 180 mikrogramma f’ 0. 5 ml
132 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
132 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI IŻ- ŻGĦAR EWLENIN
180 μ g PRE-FILLED SYRINGE
180 μg SIRINGA MIMLIJA GĦAL- LEST
180 μ g in 0.5 ml
180 μg f’ 0. 5 ml
134 PACKAGE LEAFLET:
134 FULJETT TA ’ TAGĦRIF:
Pegasys 135 micrograms solution for injection Peginterferon alfa-2a
Pegasys 135 mikrogramma soluzzjoni għall- injezzjoni Peginterferon alfa- 2a
What Pegasys is and what it is used for 2.
X’ inhu Pegasys u għal xiex jintuża 2.
Before you use Pegasys 3.
Qabel ma ’ tuża Pegasys 3.
How to use Pegasys 4.
Kif għandek tuża Pegasys 4.
How to store Pegasys 6.
Kif taħżen Pegasys 6.
WHAT PEGASYS IS AND WHAT IT IS USED FOR
X’ INHU PEGASYS U GĦALXIEX JINTUŻA
Pegasys is a long-acting interferon.
Pegasys huwa interferon li jaħdem fit- tul.
Interferon is a protein that modifies the response of the body's immune system to help fight infections and severe diseases.
Interferon huwa proteina li tbiddel ir- rispons tas- sistema immuni tal- ġisem biex tgħinu jiġġieled kontra infezzjonijiet u mard sever.
Pegasys is used for the treatment of chronic hepatitis B or C, which are viral infections of the liver.
Pegasys jintuża għall- kura ta ’ epatite B jew Ċ kronika, li huma infezzjonijiet virali tal- fwied.
Pegasys is usually used alone.
Pegasys normalment jintuża waħdu.
Pegasys is best used for this treatment in combination with ribavirin.
Għall- kura ta ’ din il- marda, jkun aħjar jekk Pegasys jintuża flimkien ma ’ ribavirin.
If you will receive combination therapy of Pegasys and ribavirin, you should also read the ribavirin package leaflet.
Jekk ser tingħata terapija kombinata ta ’ Pegasys u ribavirin, għandek taqra wkoll il- fuljett ta ’ tagħrif ta ’ ribavirin.
Pegasys is used alone only if you cannot take ribavirin for any reason.
Pegasys huwa wżat waħdu biss jekk għal xi raġuni ma tistax tieħu ribavirin.
BEFORE YOU USE PEGASYS
QABEL MA ’ TUŻA PEGASYS
Do not use Pegasys:
Tużax Pegasys:
- if you are allergic to peginterferon-alfa-2a, to any interferon or any of the other ingredients of
- jekk inti allerġiku/ a għal peginterferon- alfa- 2a, għal xi interferon jew għal sustanzi oħra ta ’
- if you have ever had a heart attack or suffer from other heart disease.
Pegasys. jekk qatt kellek xi attakk tal- qalb jew tbati minn xi mard ieħor tal- qalb.
- if you have, so called autoimmune hepatitis.
- jekk għandek dik li tissejjaħ epatite awtoimmuni.
- if you have advanced liver disease (e. g. your skin has become yellow).
- jekk għandek mard avvanzat tal- fwied (eż. il- ġilda tiegħek tkun sfaret).
- if the patient is a child less than 3 years old.
- jekk il- pazjent huwa tifel/ tifla li għandu/ ha inqas minn 3 snin.
Take special care with Pegasys:
Oqgħod attent ħafna b' Pegasys:
Tell your doctor:
Għid lit- tabib:
- if you are planning on becoming pregnant, discuss this with your doctor before starting to use
- jekk qed tippjana biex toħroġ tqila, iddiskuti dan mat- tabib tiegħek qabel ma tibda tuża Pegasys (ara
Pegasys (see Pregnancy).
Tqala).
- if you have psoriasis, it may get worse during treatment with Pegasys.
- jekk tbati minn psorjasi, din tista ’ tmur għall- agħar waqt il- kura b' Pegasys.
- if you have a problem with your liver other than hepatitis B or C.
- jekk tbati minn xi marda oħra tal- fwied minbarra epatite B jew Ċ.
- if you have diabetes or high blood pressure, your doctor may ask you to have an eye
- jekk għandek dijabete jew pressjoni tad- demm għolja, it- tabib jista ’ jgħidlek biex tagħmel eżami ta ’
examination.
l- għajnejn.
- if you notice a change in your vision.
- jekk tinnota tibdil fil- vista tiegħek.
Check
- jekk ikollok xi sintomi li jixbħu dawk ta ’ riħ jew ta ’ xi infezzjoni oħra tas- sistema respiratorja (bħal
with your doctor if you think you are getting an infection (such as pneumonia).
sogħla, deni jew xi diffikultà biex tieħu n- nifs).
- if you develop symptoms associated with a cold or other respiratory infection (such as cough,
- jekk ikollok xi sinjali ta ’ telf ta ’ demm jew ta ’ tbenġil mhux tas- soltu, kellem lit- tabib
- if you develop any signs of bleeding or unusual bruising, check with your doctor immediately.
immedjatament.
- if you develop signs of a severe allergic reaction (such as difficulty in breathing, wheezing or
- jekk tiżviluppa sinjali ta ’ reazzjoni allerġika severa (bħal diffikultà biex tieħu n- nifs, tħarħir jew
hives) while on this medication, seek medical help immediately.
ħorriqija) waqt li tkun qed tieħu din il- mediċina, fittex immedjatament għajnuna medika.
- if you have thyroid disease that is not well controlled with medicines.
- jekk għandek marda tat- tirojde li m’ hijiex ikkontrollata tajjeb bil- mediċini.
- if you have had a severe nervous or mental disorder.
- jekk int kont tbati minn mard nervuż sever jew mard mentali.
- if you have ever had depression or develop symptoms associated with depression(e. g. feelings
- jekk qatt kellek depressjoni jew tiżviluppa sintomi assoċjati ma ’ depressjoni (eż, sensazzjonijiet ta ’
of sadness, dejection etc) while on treatment with Pegasys (see section 4).
dwejjaq, niket, etċ) waqt li qiegħed fuq kura b’ Pegasys (ara sezzjoni 4).
- if you have ever had anaemia.
- jekk qatt kont tbati minn anemija.
- if you are coinfected with HIV and treated with anti HIV medicinal products.
- jekk għandek ukoll HIV u qiegħed tiġi kkurat bi prodotti mediċinali kontra l- HIV.
- if you have been withdrawn from previous therapy for Hepatitis C because of anaemia or low
- jekk ġejt imwaqqaf minn kura ta ’ qabel għal Epatite Ċ minħabba anemija jew għadd tad- demm
blood count.
baxx.
Dental and gum disorders, which may lead to loss of teeth, have been reported in patients receiving Pegasys and ribavirin combination therapy.
Disturbi dentali u tal- ħanek, li jistgħu jwasslu għal telf ta ’ snien, kienu rrapportati f’ pazjenti li rċevew terapija kombinata ta ’ Pegasys u ribavirin.
In addition, dry mouth could have a damaging effect on teeth and membranes of the mouth during long-term treatment with the combination of Pegasys with ribavirin.
Barra minn hekk, waqt kura fit- tul bit- taħtila ta ’ Pegasys u ribavirin, ħalq xott jista ’ jagħmel ħsara lis- snien u lill- membrana mukuża tal- ħalq.
You should brush your teeth thoroughly twice daily and have regular dental examinations.
Għandek taħsel snienek sew darbtejn kuljum u tagħmel eżaminazzjoni dentali regolari.
In addition some patients may experience vomiting.
Barra minn hekk xi pazjenti jista ’ jkollhom esperjenza ta ’ rimettar.
If you have this reaction, be sure to rinse your mouth thoroughly afterwards.
Jekk ikollok din ir- reazzjoni, kun żġur li tlaħlaħ ħalqek sew wara.
Tell your doctor if you are taking medicines for asthma, because the dose for your asthma medicine may need to be changed.
Għarraf lit- tabib jekk tkun qed tieħu xi mediċini kontra l- ażżma, minħabba li d- doża tal- mediċina kontra l- ażżma li tkun qed tieħu jista ’ jkun li jkollha bżonn tinbidel.
Patients who also have HIV infection.
Pazjenti li huma infettati ukoll bl- HIV.
Tell your doctor if you are taking anti-HIV therapy.
Għarraf lit- tabib jekk tkun qed tieħu terapija kontra l- HIV.
Lactic acidosis and worsening liver function are side effects associated with Highly Active Anti-Retroviral Therapy (HAART) an HIV treatment.
Aċidożi lattika u tħażżin fil- funzjoni tal- fwied, huma effetti avversi assoċjati ma ’ terapija Anti - Retrovirali Attiva Ħafna (HAART) li hi kura għall- HIV.
If you are receiving HAART, the addition of Pegasys + ribavirin may increase your risk of lactic acidosis or liver failure.
Jekk qed tingħata HAART, iż- żieda ta ’ Pegasys + ribavirin tista ’ żżid ir- riskju ta ’ aċidożi lattika jew insuffiċjenza tal- fwied.
Your doctor will monitor you for signs and symptoms of these conditions.
It- tabib tiegħek se jissorveljak għal sinjali u sintomi ta ’ dawn il- kundizzjonijiet.
Patients receiving zidovudine in combination with ribavirin and alpha interferons are at increased risk of developing anaemia.
Pazjenti li qed jirċievu zidovudine flimkien ma ’ ribavirin u alpha interferons huma f’ riskju akbar li jiżviluppaw anemija.
Please be sure to read the ribavirin Patient Leaflet also.
Jekk jogħġbok ħu ħsieb li taqra wkoll il- Fuljett ta ’ Tagħrif ta ’ ribavirin.
Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed
Jekk jogħġbok għarraf lit- tabib jew lill- ispiżjar tiegħek jekk qed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
In studies in pregnant animal, interferons have sometimes caused miscarriage.
Fi studji f’ annimali tqal, interferons xi kultant ikkawżaw korriment.
The effect on human pregnancy is not known.
L- effett fuq it- tqala fil- bniedem mhux magħruf.
When Pegasys is used in combination with ribavirin, both male and female patients must take special precautions in their sexual activity if there is any chance for pregnancy to occur as ribavirin can be very damaging to an unborn baby:
Meta Pegasys jintuża flimkien ma ’ ribavirin, kemm pazjenti rġiel kif ukoll nisa iridu jieħdu prekawzjonijiet speċjali fl- attività sesswali tagħhom jekk hemm xi ċans li sseħħ tqala minħbba li ribavirin jista ’ jkun ta ’ ħsara kbira għat- tarbija li għada ma twelditx:
- if you are a woman of childbearing age who is taking Pegasys in combination with ribavirin, you
- jekk inti mara ta ’ età li jista ’ jkollok it- tfal u li qed tieħu Pegasys f’ taħlita ma ’ ribavirin, irid ikollok
must have a negative pregnancy test before treatment, each month during therapy and for the 4 months after treatment is stopped.
test negattiv tat- tqala qabel il- kura, kull xahar waqt il- kura u għal 4 xhur wara li l- kura titwaqqaf.
You and your partner must each use an effective contraceptive during the time you are taking the treatment and for 4 months after stopping treatment.
Int u s- sieħeb tiegħek tridu tużaw kontraċettiv effettiv kull wieħed waqt il- kura u għal 4 xhur wara li tkun intemmet il- kura.
This can be discussed with your doctor.
Tista ’ tiddiskuti dan mat- tabib tiegħek.
- if you are a man who is taking Pegasys in combination with ribavirin, do not have sex with a
- jekk inti raġel li qed tieħu Pegasys f’ taħlita ma ’ ribavirin, m’ għandekx tagħmel is- sess ma ’ mara tqila
pregnant woman unless you use a condom.
sakemm ma tużax kondom.
This will lessen the chance for ribavirin to be left in the woman’ s body.
Dan inaqqas iċ- ċans li ribavirin jitħalla fil- ġisem tal- mara.
If your female partner is not pregnant now but is of childbearing age, she must be tested for pregnancy each month during treatment and for the 7 months after treatment has stopped.
Jekk is- sieħba femminili tiegħek mhix tqila bħalissa iżda hija ta ’ età li jista ’ jkollha it- tfal, hija għandha tiġi ttestjata għat- tqala kull xahar waqt il- kura u għal 7 xhur wara li titwaqqaf il- kura.
You and your partner must each use an effective contraceptive during the time you are taking the treatment and for 7 months after stopping treatment.
Int u s- sieħba tiegħek għandkom tużaw kontraċettiv effettiv kull wieħed matul iż- żmien li int qed tieħu l- kura u għal 7 xhur wara li tkun intemmet il- kura.
136 Ask your doctor or pharmacist for advice before taking any medicine.
Itlob il- parir tat- tabib jew ta ’ l- ispiżjar tiegħek qabel tieħu xi mediċina.
It is not known whether this product is present in human milk.
Mhux magħruf jekk dan il - prodott huwiex preżenti fil- ħalib tal- bniedem.
Therefore, do not breast-feed an infant if you are taking Pegasys.
Għalhekk, treddgħax lit- tarbija jekk qed tieħu Pegasys.
In combination therapy with ribavirin, take notice of the respective informing texts of ribavirin containing medicinal products.
136 F’ terapija kombinata ma ’ ribavirin, ara l- fuljetti ta ’ tagħrif rispettivi tal- prodotti mediċinali li fihom ribavirin.
Do not drive or use machinery if you feel drowsy, tired, or confused while taking Pegasys.
M’ għandekx issuq jew tagħmel użu minn għodda jew tħaddem magni jekk tħossok bi ngħas, għajjien, jew konfuż waqt li tkun qed tieħu Pegasys.
Important information about some of the ingredients of Pegasys:
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Pegasys:
Must not be given to premature babies or neonates.
M’ għandux jingħata lil trabi prematuri jew tat- twelid.
May cause toxic reactions and allergic reactions in infants and children up to 3 years old.
Jista ’ jikkawża reazzjonijiet tossiċi u allerġiċi fi trabi u tfal ta ’ età ta ’ mhux aktar minn 3 snin.
HOW TO USE PEGASYS
KIF GĦANDEK TUŻA PEGASYS
Always take Pegasys as your doctor has told you.
Dejjem għandek tieħu Pegasys skond il- parir eżatt tat- tabib.
Your doctor has prescribed Pegasys specifically for you and your current condition; do not share this medicine with anyone else.
It- tabib ippreskriva Pegasys speċifikament għalik u għall- kundizzjoni li qed issofri minnha; taqsamx din il- mediċina ma ’ xi ħadd ieħor.
Pegasys dosing Your doctor has determined the exact dose of Pegasys, and will tell you how often to use it.
Dożaġġ ta ’ Pegasys It- tabib iddetermina id- doża eżatta ta ’ Pegasys li għandek tieħu, u ser jgħidlek kemm il- darba trid tużah.
If necessary, the dose may be changed during treatment.
Jekk hemm bżonn, id- doża tista ’ tinbidel waqt il- kura.
Do not exceed the recommended dose.
Taqbiżx id- doża rakkomandata.
Pegasys given alone or in combination with ribavirin is usually given at a dose of 180 micrograms once a week.
Pegasys mogħti waħdu jew ikkombinat ma ’ ribavirin huwa ġeneralment mogħti f’ doża ta ’ 180 mikrogrammi darba fil- ġimgħa.
The duration of combination treatment varies from 4 to 18 months depending on the type of virus you are infected with, on treatment response and whether you have been treated before.
It- tul tal- kura kombinata tvarja minn 4 sa 18- il xahar skond it- tip ta ’ virus li tkun infettat bih, ir - rispons għall- kura u jekk kontx ikkurat/ a minn qabel.
Please check with your doctor and follow the recommended duration of treatment.
Jekk jogħġbok aċċerta ruħek mat- tabib tiegħek u ħu l- kura għall- perijodu ta ’ żmien irrakkomandat.
Pegasys injection is normally taken at bedtime.
L- injezzjoni ta ’ Pegasys normalment tittieħed qabel l- irqad.
Pegasys is intended for subcutaneous use (under the skin).
Pegasys huwa maħsub għal użu minn taħt il- ġilda (għal taħt il- ġilda).
This means that Pegasys is injected with a short needle into the fatty tissue under the skin in the abdomen or thigh.
Dan ifisser li Pegasys huwa injettat b’ labra qasira fit- tessut xaħmi ta ’ taħt il- ġilda fl- addome jew fil- koxxa.
If you are injecting this medicine yourself, you will be instructed how to give the injection.
Jekk tkun ser tinjetta din il- mediċina inti stess, ser tingħata struzzjonijiet kif għandek tagħti l- injezzjoni.
Detailed instructions are provided at the end of this leaflet (see “ How to self-inject Pegasys”).
Struzzjonijiet dettaljati huma pprovduti fl- aħħar ta ’ dan il- fuljett (ara “ Kif tinjetta lilek innifsek b' Pegasys ”).
Use Pegasys exactly as described by your doctor, for as long as prescribed by your doctor If you have the impression that the effect of Pegasys is too strong or too weak, talk to your doctor or pharmacist.
Jekk tħoss li l - effett ta ’ Pegasys huwa qawwi wisq jew dgħajjef wisq, kellem lit- tabib jew lill- ispiżjar tiegħek.
Combination therapy with ribavirin in chronic hepatitis C In the case of combination therapy with Pegasys and ribavirin, please follow the dosing regimen recommended by your doctor.
Terapija Kombinata ma ’ ribavirin f’ epatite Ċ kronika Fil- każ ta ’ terapija kombinata b' Pegasys u ribavirin, jekk jogħġbok segwi d- dożaġġi rakkomandati mit- tabib tiegħek.
● If you use more Pegasys than you should:
• Jekk tuża Pegasys aktar milli suppost:
Contact your doctor or pharmacist as soon as possible.
Kellem lit- tabib jew lill- ispiżjar tiegħek immedjatament.
● If you forget to take Pegasys:
• Jekk tinsa tieħu Pegasys:
If you realise you missed your injection 1 or 2 days after it was scheduled, you should inject your recommended dose as soon as possible.
Jekk tinduna li nsejt tieħu l- injezzjoni tiegħek ġurnata jew jumejn wara li suppost, għandek tinjetta d - doża rakkomandata tiegħek immedjatament.
Take your next injection on the regularly scheduled day.
Ħu l- injezzjoni li jmiss fil- ġurnata tas- soltu.
If you realise you missed your injection 3 to 5 days after it was scheduled, you should take your injection at the recommended dose as soon as possible.
Jekk tinduna li nsejt tieħu l- injezzjoni tiegħek tlett ijiem sa ħamest ijiem wara li suppost, għandek tinjetta d- doża rakkomandata tiegħek immedjatament.
Take your next doses at 5 day intervals until you return to your regularly scheduled day of the week.
Ħu d- dożi li jmiss f’ intervalli ta ’ ħamest ijiem sakemm terġa ’ tiġi fil- ġurnata li ssoltu tieħu d- doża fiha.
As an example:
Bħala eżempju:
Your regular weekly Pegasys injection is on Monday.
L- injezzjoni ta ’ kull ġimgħa ta ’ Pegasys is- soltu tiġi njettata t- Tnejn.
You remember on Friday that you forgot to take your injection on Monday (4 days late). You should inject your regularly scheduled dose immediately on Friday and take your next injection on Wednesday (5 days after your Friday dose).
Għandek tinjetta d- doża tas - soltu tiegħek immedjatament il- Ġimgħa u ħu l- injezzjoni li jmiss l- Erbgħa (ħamest ijiem wara d- doża tal- Ġimgħa).
Your next injection will be on the Monday, 5 days later after
L- injezzjoni li jmissek ser tkun it- Tnejn, ħamest ijiem wara l- injezzjoni ta ’ l- Erbgħa.
You are now back on your regularly scheduled day and should continue your injections every Monday.
137 Jekk tinduna li nsejt tieħu l- injezzjoni tiegħek sitt ijiem wara li suppost, għandek tistenna u tieħu d- doża l- ġurnata ta ’ wara, il- ġurnata tas- soltu.
Contact your doctor or pharmacist if you need any help determining how to manage a missed dose of Pegasys.
Kellem lit- tabib jew lill- ispiżjar tiegħek jekk ikollok bżonn xi għajnuna dwar x’ għandek tagħmel meta tinsa tieħu doża ta ’ Pegasys.
If you have any further questions on the use of this product, ask your doctor or pharmacist
Jekk għandek aktar mistoqsijiet dwar l- użu ta ’ dan il- prodott, staqsi lit- tabib jew lill- ispiżjar tiegħek.
Like all medicines, Pegasys can cause side effects, although not everybody gets them.
Bħall kull mediċina oħra, Pegasys jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Some people get depressed when taking Pegasys alone or in combination treatment with ribavirin, and in some cases people have had suicidal thoughts or aggressive behaviour (sometimes directed against others).
Xi nies taqbadhom depressjoni meta jieħdu Pegasys waħdu jew f’ kura kombinata ma ’ ribavirin, u f’ ċertu każijiet nies kellhom ħsibijiet ta ’ suwiċidju jew mġieba aġġressiva (xi kutant mmirata lejn oħrajn).
Some patients have actually committed suicide.
Attwalment, xi pazjenti kkommettew suwiċidju.
Be sure to seek emergency care if you notice that you are becoming depressed or have suicidal thoughts or change in your behaviour.
Kun żgur li tfittex kura ta ’ emerġenza jekk tinnota li qed taqbdek depressjoni jew jekk għandek ħsibijiet ta ’ suwiċidju jew bidliet fl- imġieba tiegħek.
You may want to consider asking a family member or close friend to help you stay alert to signs of depression or changes in your behaviour.
Tista ’ wkoll tikkunsidra ssaqsi membru tal- familja jew ħabib viċin biex jgħinuk toqgħod attent għal sinjali ta ’ depressjoni jew bidliet fl- imġiegħba tiegħek.
During treatment your doctor will take blood samples regularly to check for changes in your white blood cells (cells that fight infection), red blood cells (cells that carry oxygen), platelets (blood clotting cells), liver function or changes in other laboratory values.
Waqt il- kura it- tabib tiegħek ser jieħu regolarment kampjuni tad- demm biex jara jekk ikunx hemm xi tibdiliet fiċ- ċelloli bojod tad- demm tiegħek (ċelloli li jiġġieldu l- infezzjoni), fiċ- ċelloli ħomor tad- demm (ċelloli li jġorru l- ossiġnu), fil- plejtlits (ċelloli li jgħaqqdu d- demm), fil- funzjoni tal- fwied jew tibdiliet f’ valuri oħra tal- laboratorju.
Tell your doctor immediately if you notice any of the following side effects: severe chest pain; persistent cough; irregular heartbeat; trouble breathing; confusion; depression; severe stomach pain; blood in stool (or black, tarry stools); severe nosebleed; fever or chills; problems with your eyesight.
Għarraf lit- tabib tiegħek immedjatament jekk tinnota xi wieħed minn dawn l- effetti sekondarji: uġigħ qawwi fis- sider; sogħla persistenti; qalb tħabbat b’ mod irregolari; diffikultà biex tieħu n- nifs; konfużjoni; depressjoni; uġigħ ta ’ żaqq qawwi; demm fl- ippurgar (jew ippurgar iswed, qisu qatran); fsada qawwija mill- imnieħer; deni jew rogħda ta ’ bard; problemi fil- vista tiegħek.
These side effects can be serious and you may need urgent medical attention.
Dawn l- effetti sekondarji jistgħu jkunu serji u jista ’ jkollok bżonn attenzjoni medika urġenti.
Very common side effects with the combination of Pegasys and ribavirin (occurring in more than 10 out of 100 patients) are:
Effetti komuni ħafna bit- taħlita ta ’ Pegasys u ribavirin (li jseħħu f’ aktar minn 10 minn kull 100 pazjent) huma:
Metabolic disorders:
Disturbi metaboliċi:
Loss of appetite Psychiatric disorders: feeling depressed (feeling low, feeling bad about yourself or feeling hopeless), anxiety, inability to sleep Nervous system disorders:
Disturbi fis- sistema nervuża:
Headache, difficulty concentrating and dizziness Respiratory disorders: cough, shortness of breath Gastrointestinal disorders: diarrhoea, nausea, abdominal pain Skin disorders: loss of hair, and skin reactions (including itching, dermatitis and dry skin).
Disturbi fil- ġilda: telf ta ’ xagħar, u reazzjonijiet fil- ġilda (inkluż ħakk, dermatite u ġilda xotta).
Musculoskeletal disorders: pain in joints and muscles General disorders: fever, weakness, tiredness, shaking, chills, pain, injection site irritation and irritability (getting easily upset)
Disturbi muskolu- skeletrali: uġigħ fil- ġogi u fil- muskoli Disturbi ġenerali: deni, indebboliment, għeja, rogħda, tertir, uġigħ, irritazzjoni fis- sit ta ’ l- injezzjoni, u irritabilità (tiddejjaq malajr)
Common side effects with the combination of Pegasys and ribavirin occurring in more than 1 out of 100 patients:
Effetti sekondarji komuni bit- taħlita ta ’ Pegasys u ribavirin li dehru f’ aktar minn 1 minn kull 100 pazjent:
Upper respiratory infection, bronchitis, fungal infection of the mouth and herpes (a common recurring viral infection affecting the lips, mouth) Blood disorders:
Infezzjonijiet ikkawżati mill- moffa, virali u mill- batterja. Infezzjoni fl- apparat respiratorju ta ’ fuq, bronkite, infezzjoni tal- fungu fil- ħalq u herpes (infezzjoni virali rikorrenti, li sseħħ b’ mod komuni, li taffettwa x- xofftejn, ħalq) Disturbi fid- demm:
Low platelet count (affecting the clotting ability), anaemia (low red cell count) and enlarged lymph glands.
Għadd ta ’ plejtlits baxx (li jaffettwa l- abilità li jagħqad), anemija (għadd ta ’ ċelluli ħomor baxx) u glandoli tal- limfa mkabbra.
Endocrine disorders: overactive and underactive thyroid gland Psychiatric disorders:
Disturbi endokrinarji: glandola tat- tirojde attiva ż- żejjed jew mhux attiva biżżejjed Disturbi psikjatriċi:
Mood / emotion changes, aggression, nervousness, decreased sexual desire
Tibdil fil- burata/ emozzjonali, aggressjoni, nervi, tnaqqis fix- xewqa sesswali Disturbi fis- sitema nervuża:
138 Nervous system disorders:
138 Disturbi fl- għajnejn:
Blurry vision, eye pain, eye inflammation and dry eyes.
Vista mċajpra, uġigħ fl- għajnejn, infjammazjoni fl- għajnejn u għajnejn xotti.
Ear disorders:
Disturbi fil- widnejn:
Sensation of room spinning, ear pain Cardiac disorders:
Sensazzjoni li l- kamra qed iddur bik, uġigħ fil- widnejn Disturbi fil- qalb:
Rapid heart rate, pulsation of the heart beats, swelling in the extremities.
Rata ta ’ taħbit tal- qalb mgħaġġla, taħbit tal- qalb kif jinħass fil- polz, nefħa fl - estremitajiet.
Flushing Respiratory disorders: shortness of breath with activity, nose bleeds, nose and throat inflammation, infections of the nose and sinuses (air-filled spaces found in the bones of the head and face), runny nose, sore throat.
Fwawar Disturbi respiratorji: qtugħ ta ’ nifs ma ’ l- attività, fsada mill- imnieħer, infjammazzjoni fl- imnieħer u fil - griżmejn, infezzjonijiet fl- imnieħer u fis- sinus (spażji mimlijin bl- arja li jinstabu fl- għadam tar- ras u tal - wiċċ), imnieħer iqattar, uġigħ fil- griżmejn.
Vomiting, indigestion, difficulty swallowing, mouth ulceration, bleeding gums, inflammation of tongue and mouth, flatulence (excess amount of air or gases), dry mouth and loss of weight.
Rimettar, indiġestjoni, diffikultà biex tibla ’, ulċerazzjoni fil- ħalq, fsada mill - ħanek, infjammazzjoni ta ’ l- ilsien u l- ħalq, gass (ammont żejjed ta ’ arja jew gassijiet), ħalq xott u telf ta ’ piż.
Skin disorders:
Disturbi fil- ġilda:
Rash, increased sweating, psoriasis, hives, eczema, sensitivity to sunlight, night sweats Musculoskeletal disorders:
Raxx, żieda fl- għaraq, psorjasi, ħorriqija, ekżema, sensittività għad- dawl tax- xemx, tgħereq ħafna matul il- lejl Disturbi muskolu- skeletrali:
Back pain, joint inflammation, muscle weakness, bone pain, neck pain, muscle pain, muscle cramps Reproductive system disorders:
Uġigħ fid- dahar, infjammazzjoni fil- ġogi, indebboliment fil- muskoli, uġigħ fl- għadam, uġigħ fl- għonq, uġigħ fil- muskoli, bugħawwieġ fil- muskoli Disturbi fis- sistema riproduttiva:
Impotence (inability to maintain an erection) General disorders:
Impotenza (nuqqas fil- ħila biex iżżomm erezzjoni) Disturbi ġenerali:
Chest pain, flu-like illness, malaise (not feeling well), lethargy, hot flushes, thirst
Uġigħ fis- sider, marda tixbaħ lill- influwenza, telqa (ma tħossokx tajjeb), letarġija, fwawar, għatx
Uncommon side effects with the combination of Pegasys and ribavirin occurring in more than 1 out of 1000 patients:
Effetti sekondarji mhux komuni bit- taħlita ta ’ Pegasys u ribavirin li dehru f’ aktar minn 1 minn kull 1000 pazjent:
Lung infection, skin infections Neoplasms benign and malignant disorders:
Infezzjoni fil- pulmun, infezzjonijiet fil- ġilda Neoplażmi beninni u malinni:
Liver tumour Immune disorders: sarcoidosis (areas of inflamed tissue occurring throughout the body), inflammation of the thyroid Endocrine disorders:
Tumur fil- fwied Disturbi immuni: sarkojdożi (partijiet ta ’ tessut infjammat li jseħħu f’ kull parti tal- ġisem), infjammazzjoni tat- tirojde Disturbi fis- sistema endokrinarja:
Diabetes (high blood sugar) Metabolic disorders:
Dijabete (zokkor għoli fid- demm) Disturbi fil- metaboliżmu:
Dehydration Psychiatric disorders:
Deidratazzjoni Disturbi psikjatriċi:
Thoughts of suicide, hallucinations (severe problems with personality and deterioration in normal social functioning) Nervous system disorders:
Ħsibijiet ta ’ suwiċidju, alluċinazzjonijiet (problemi severi bil- personalità u deterjorament fil- funzjoni soċjali normali) Disturbi fis- sistema nervuża:
Peripheral neuropathy (disorder of the nerves affecting the extremities) Eye disorders:
Newropatija periferali (disturbi fin- nervituri li jaffettwaw l- estremitajiet) Disturbi fl- għajnejn:
Bleeding in the retina (back of the eye) Ear disorders:
Fsada fir- retina (il- parti ta ’ wara ta ’ l- għajn) Disturbi fil- widnejn:
Hearing loss Vascular disorder:
Telf tas- smigħ Disturbi vaskulari:
High blood pressure Respiratory disorders:
Pressjoni għolja Disturbi respiratorji:
Wheezing Gastrointestinal disorders: gastrointestinal bleeding Liver disorders:
Tħarħir Disturbi gastro- intestinali: fsada gastro- intestinali Disturbi fil- fwied:
Poor functioning of the liver
Funzjoni ħażina tal- fwied
Rare side effects with the combination of Pegasys and ribavirin occurring in more than 1 in 10,000 patients:
Effetti sekondarji rari bit- taħlita ta ’ Pegasys u ribavirin li dehru f’ aktar minn 1 minn kull 10, 000 pazjent:
Infection of the heart, infection of the external ear Blood disorders: severe reduction in red blood cells, white blood cells and platelet Immune system disorders:
Infezzjoni tal- qalb, infezzjoni tal- parti ta ’ barra tal- widna Disturbi tad- demm: tnaqqis qawwi taċ- ċelluli l- ħomor tad- demm, taċ- ċelluli l- bojod tad- demm u tal - plejtlits Disturbi fis- sistema immuni:
Severe allergic reaction, systemic lupus erythematosus (an illness where the body attacks its own cells), rheumatoid arthritis (an autoimmune disease) Endocrine disorders:
Reazzjoni allerġika severa, lupus eritematosus sistemika (marda fejn il - ġisem jattakka iċ- ċelluli tiegħu stess), artrite rewmatojda (marda awtoimmuni) Disturbi endokrinarji:
Diabetic ketacidosis, a complication of uncontrolled diabetes Psychiatric disorders:
Ketoaċidożi dijabetika, komplikazzjoni ta ’ dijabete mhux ikkontrollata Disturbi psikjatriċi:
Suicide, psychotic disorders (severe problems with personality and deterioration in normal social functioning) Nervous system disorders:
Disturbi fis- sistema nervuża:
Coma (a deep prolonged unconsciousness), seizures, facial palsy (weakness of the facial muscle) Eye disorders:
Koma (tintilef minn sensik fil- fond u fit- tul), aċċessjonijiet, paralisi fil - wiċċ (indebboliment fil- muskoli tal- wiċċ).
Inflammation and swelling of the optic nerve, inflammation of the retina, ulceration of the cornea Cardiac disorders:
Infjammazzjoni u nefħa tan- nerv ottiku, infjammazzjoni tar- retina, ulċerazzjoni tal - korneja
Heart attack, heart failure, heart pain, rapid heart rhythm, rhythm disorders or inflammation of the lining of the heart and cardiac muscle.
Attakk ta ’ qalb, insuffiċjenza tal- qalb, uġigħ fil- qalb, ritmu tal- qalb mgħaġġel, disturbi fir- ritmu jew infjammazzjoni tar- rita li tiksi l- qalb u tal- muskolu tal- qalb.
Respiratory disorders:
Fsada fil- moħħ u infjammazzjoni fil- kanali.
139 Gastrointestinal disorders: stomach ulcer, inflammation of the pancreas Liver disorders:
Pnewmonja interstizjali (infjammazjoni tal- pulmun inkluż riżultat fatali), demm magħqud fil- pulmun Disturbi gastro- intestinali:
Liver failure, bile duct inflammation, fatty liver Musculoskeletal disorders:
Insuffiċjenza tal- fwied, infjammazzjoni tal- kanal tal- bile, fwied xaħmi Disturbi muskolu- skeletrali:
Inflammation of the muscles Renal disorders: renal failure Injury or poisoning:
Insuffiċjenza tal- kliewi Korriment jew avvelenament:
Substance overdose
Doża eċċessiva tas- sustanza
Very rare side effects with the combination of Pegasys and ribavirin occurring in less than 1 in 10,000 patients:
Effetti sekondarji rari ħafna bit- taħlita ta ’ Pegasys u ribavirin li dehru f’ anqas minn 1 minn kull 10, 000 pazjent:
Blood disorders: aplastic anaemia (failure of the bone marrow to produce red blood cells, white blood cells and platelets) Immune System disorders:
Anemija aplastika (insuffiċjenza tal- mudullun biex jipproduċi ċelluli ħomor tad - demm, ċelluli bojod tad- demm u plejtlits) Disturbi fis- Sistema Immuni:
Idiopathic (or thrombotic) thrombocytopenic purpura (increased bruising, bleeding, decreased platelets, anaemia and extreme weakness) Eye disorders:
Tromboċitopenja purpura (żieda fit- tbenġil, fsada, tnaqqis fil- plejtlits, anemija u debbulizza estrema) idjopatika (jew trombotika) Disturbi fl- għajnejn:
Loss of vision Skin disorders:
Telf tal- vista Disturbi fil- ġilda:
Toxic epidermal necrolysis/ Stevens Johnson Syndrome/ erythema multiforme (a spectrum of rashes with varying degrees of severity including death which may be associated with blisters in the mouth, nose, eyes and other mucosal membranes and sloughing of the affected area of the skin), angioedema (swelling in the skin and mucosa).
Nekroliżi epidermali tossika/ Sindrome Stevens Johnson / eritema multiforme (firxa ta ’ raxxijiet bi gradi varji ta ’ severità inkluż mewt li tista ’ tkun assoċjata ma ’ nfafet fil- ħalq, imnieħer, għajnejn u membrani tal- mukoża oħrajn u tqaxxir tal- parti affettwata tal- ġilda), anġoedima (nefħa fil - ġilda u fil- mukoża).
Adverse events with unknown frequency:
Avvenimenti avversi bi frekwenza mhux magħrufa:
Nervous system:
Sistema nervuża:
Stroke Eye disorders:
Puplesija Disturbi fl- għajnejn:
Rare form of retinal detachment with fluid in the retina.
Forma rari ta ’ distakk tar- retina bi fluwidu preżenti fir- retina.
Musculoskeletal disorders:
Disturbi muskolu- skeletrali:
Serious muscle damage and pain.
Ħsara serja fil- muskoli u uġigħ.
When Pegasys is used alone in hepatitis B or C patients, some of these effects are less likely to occur.
Meta Pegasys ikun użat waħdu f’ pazjenti b’ epatite B jew Ċ, xi wħud minn dawn l- effetti għandhom anqas probabbilità li jseħħu.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, 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.
HOW TO STORE PEGASYS
KIF TAĦŻEN PEGASYS
Do not use Pegasys after the expiry date which is stated on the label.
Tużax Pegasys wara d- data ta ’ skadenza li tidher fuq it- tikketta.
Do not use Pegasys if the vial or packaging is damaged, if the solution is cloudy or if it has floating particles or if the medicine is any colour besides colourless to light yellow.
M’ għandekx tuża Pegasys jekk il- kunjett jew il- pakkett ikollhom xi ħsara, jekk is- soluzzjoni hija mdardra jew jekk għandha xi frak, jew jekk il- mediċina tkun xi kulur ieħor ħlief trasparenti għal isfar ċar.
What Pegasys contains
140 X’ fih Pegasys
- The active substance is peginterferon alfa-2a (conjugation of recombinant interferon alfa-2a
- Is- sustanza attiva hija peginterferon alfa- 2a (interferon alfa- 2a rikombinanti konjugat ma ’ bis -
with bis-[monomethoxy polyethylene glycol] of a molecular mass, Mn, of 40 000), 135 micrograms in a single dose vial.
[monomethoxy polyethylene glycol] ta ’ massa molekulari, Mn, ta ’ 40, 000.), 135 mikrogramma f’ kunjett ta ’ doża waħda.
- The other ingredients are sodium chloride, polysorbate 80, benzyl alcohol, sodium acetate,
- Is- sustanzi l- oħra huma sodium chloride, polysorbate 80, benzyl alcohol, sodium acetate, acetic
acetic acid and water for injections.
acid u ilma għall- injezzjonijiet.
140 What Pegasys looks like and contents of the pack
Id- Dehra ta ’ Pegasys u l- kontenuti tal- pakkett
Pegasys is presented as a solution for injection in a vial (1 ml) available in packs containing 1 or 4 single dose vials.
Pegasys huwa ppreżentat bħala soluzzjoni għall- injezzjoni f’ kunjett (1 ml) disponnibli f’ pakketti li fihom 1 jew 4 kunjetti ta ’ doża waħda.
Roche Pharma AG Emil-Barell-Str.1 D-79639 Grenzach-Wyhlen Germany
Roche Pharma AG Emil- Barell- Str. 1 D- 79639 Grenzach- Wyhlen Il- Ġermanja
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Għall kull tagħrif dwar din il- mediċina, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq:
HOW TO SELF INJECT PEGASYS
KIF TINJETTA PEGASYS LILEK INNIFSEK
The following instructions explain how to use Pegasys single dose vials to inject yourself.
L- istruzzjonijiet li ġejjin jispjegaw kif tuża l- kunjetti ta ’ doża waħda ta ’ Pegasys biex tinjetta lilek innifsek.
Please read the instructions carefully and follow them step by step.
Jekk jogħġbok aqra l- istruzzjonijiet b’ attenzjoni u segwihom pass pass.
Your doctor or his/ her assistant will instruct you on how to give the injections.
It- tabib tiegħek jew l - assistent tat- tabib/ a tieghek ser jurik kif tagħti l- injezzjoni.
Getting ready
Preparamenti ta ’ qabel
Wash your hand carefully before handling any of the items.
Aħsel idejk sew qabel ma tmiss xi wieħed mill- oġġetti.
Collect the necessary items before beginning:
Iġbor l- affarijiet li għandek bżonn qabel ma tibda:
Included in the pack:
Inkluż fil- pakkett:
- a vial of Pegasys solution for injection
- kunjett mimli b’ soluzzjoni għall- injezzjoni ta ’ Pegasys
Not included in the pack:
Mhux inkluż fil- pakkett:
- a 1 ml syringe
- siringa ta ’ 1 ml
- a long needle to withdraw Pegasys from the vial
- labra twila biex tiġbed Pegasys mill- kunjett
- a short needle for the subcutaneous injection
- labra qasira għall- injezzjoni minn taħt il- ġilda
- a cleansing swab
142
- small bandage or sterile gauze
- mselħa biex tnaddaf
- an adhesive bandage
- faxxa li teħel
- a container for the waste material
- kontenitur għar- rimi għall- affarijiet użati
Measuring the dose of Pegasys
Kif tkejjel id- doża ta ’ Pegasys
● Remove the protective cap from the Pegasys vial (1).
Neħħi l- għatu protettiv mill- kunjett ta ’ Pegasys (1). ●
You can save the swab to clean the skin area where you will inject Pegasys.
Naddaf il- wiċċ tal- gomma tal- kunjett b’ imselħa li tnaddaf. ● Tista ’ żżomm l- istess imselħa biex tnaddaf il- ġilda ta ’ fejn tkun ser tinjetta Pegasys.
● Remove the syringe from the wrapping.
Neħħi s- siringa mill- pakkett.
Do not touch the tip of the syringe. ● Take the long needle and place it firmly on to the tip of the syringe (2).
Tmisx it- tarf tas- siringa. ● Ħu l- labra t- twila u waħħalha sew mat- tarf tas- siringa (2). ●
● Remove the needle guard without touching the needle and keep the syringe with the needle in your hand. ● Insert the needle through the rubber top of the Pegasys vial (3).
Neħħi l- għatu tal- labra mingħajr ma tmiss il- labra u żomm is- siringa bil- labra f’ idejk. ● Daħħal il- labra minn ġol- wiċċ tal- gomma tal- kunjett ta ’ Pegasys (3). ●
● Hold the vial and syringe in one hand and turn the vial and the syringe upside down (4).
Żomm il- kunjett u s- siringa f’ id waħda u dawwar il- kunjett u s- siringa ta ’ taħt fuq (4). ●
With the syringe pointing up, make certain that the tip of the needle is in the Pegasys solution.
Bis- siringa tipponta ’ l fuq, kun ċert li t- tarf tal- labra jkun fis- soluzzjoni ta ’ Pegasys.
Your other hand will be free to move the plunger of the syringe.
L- id l- oħra tkun ħielsa biex tmexxi il- planġer tas- siringa. • Iġbed il- planġer lura bil- mod sabiex tiġbed fis- siringa ftit aktar mid- doża li kitiblek it- tabib.
143 ● Slowly pull back the plunger to withdraw a bit more than the dose prescribed by your doctor into the syringe. ● Hold the syringe with the needle in the vial pointing up, remove the syringe from the long needle while keeping the needle in the vial and without touching the tip of the syringe. ● Take the short needle and place it firmly on to the tip of the syringe (5).
Ħu l- labra l- qasira u waħħalha sew mal- ponta tas- siringa (5). ●
● Remove the needle guard from the syringe needle. ● Check for air bubbles in the syringe.
Neħħi l- għatu tal- labra mil- labra tas- siringa. ● Aċċerta ruħek li ma jkunx hemm xi bżieżaq ta ’ l- arja fis- siringa.
If you see any bubbles, pull the plunger slightly back.
Jekk tara xi bżieżaq, iġbed ftit ● lura l- planġer.
To remove air bubbles from the syringe, hold the syringe with the needle pointing up.
Biex tneħħi xi bżieżaq ta ’ l- arja minn ġos- siringa, żomm is- siringa bil- labra tipponta ’ l fuq.
Tap the syringe gently to bring the bubbles to the top.
Tektek is- siringa bil- mod sabiex il- bżieżaq jitilgħu ’ l fuq.
Push the plunger up slowly to the correct dose.
Imbotta il- planġer ’ l fuq bil- mod sad- doża t- tajba.
Replace the needle guard and place the syringe in a horizontal position until ready for use. ● Allow the solution to reach room temperature before injection or warm the syringe between your palms. ● Visually inspect the solution prior to administration: do not use if it is discoloured or if particles are present.
Spezzjona viżwalment is- soluzzjoni qabel l- għotja: tużahiex jekk ikollha kulur mhux tas- soltu ● jew jekk ikun fiha xi frak.
You are now ready to inject the dose.
Int issa lest biex tinjetta d- doża.
Injecting the solution
Injezzjoni tas- soluzzjoni
● Select the injection site in the abdomen or thigh (except your navel or waistline).
Għażel post għall- injezzjoni fl- addome jew fil- koxxa (minbarra fiż- żokra jew fil- qadd).
Change your injection site each time. ● Clean and disinfect the skin where the injection is to be made with a cleansing swab. ● Wait for the area to dry. ● Remove the needle guard. ● With one hand, pinch a fold of loose skin.
Naddaf u ddiżinfetta b’ imselħa l- ġilda fejn tkun ser tinjetta. ● Stenna l- post jinxef. ● Neħħi l- għatu tal- labra. ● B’ id waħda, oqros ftit mill- ġilda biex tifforma tinja.
With your other hand hold the syringe as you would a pencil. ● Insert the needle all the way into the pinched skin at an angle of 45° to 90° (6).
Daħħal il- labra kollha fil- ġilda maqrusa b’ angolu ta ’ 45° sa 90° (6). ●
● Inject the solution by gently pushing the plunger all the way down. ● Pull the needle straight out of the skin. ● Press the injection site with a small bandage or sterile gauze if necessary for several seconds.
144 Injetta s- soluzzjoni billi timbotta bil- mod il- planġer s’ isfel nett. ● Iġbed il- labra ’ l barra mill- ġilda. ● Jekk hemm bżonn għafas għal ftit sekondi l- post fejn tajt l- injezzjoni b’ biċċa faxxa żgħira jew ● b’ garża sterili.
Do not massage the injection site.
Timmassaġjax il- post ta ’ fejn tajt l- injezzjoni.
If there is bleeding, cover with an adhesive bandage.
Jekk joħroġ xi demm, għatti b’ biċċa faxxa adeżiva.
Disposal of the injection materials
Rimi ta ’ materjali ta ’ l- injezzjoni
The syringe, needle and all injection materials are intended for single use and must be discarded after the injection.
Is- siringa, labra u l- materjali kollha ta ’ l- injezzjoni huma maħsuba għall- użu ta ’ darba biss u għandhom jintremew wara l- injezzjoni.
Dispose of the syringe and needle safely in a closed container.
Armi s- siringa u l- labra b’ mod sigur f’ kontenitur magħluq.
Ask your doctor, hospital or pharmacist for an appropriate container.
Staqsi lit- tabib, l- isptar jew lill- ispiżjar tiegħek għal kontenitur xieraq.
144 PACKAGE LEAFLET:
145 FULJETT TA ’ TAGĦRIF:
Pegasys 180 micrograms solution for injection Peginterferon alfa-2a
Pegasys 180 mikrogramma soluzzjoni għall- injezzjoni Peginterferon alfa- 2a
Interferon is a protein that modifies the response of the body's immune system to help fight infections and severe diseases.
Interferon huwa proteina li tbiddel ir- rispons tas- sistema immuni tal- ġisem biex tgħin fil- ġlied kontra infezzjonijiet u mard qalil.
If you receive combination therapy of Pegasys and ribavirin, you should also read the ribavirin package leaflet.
Jekk ser tingħata terapija kombinata ta ’ Pegasys u ribavirin, għandek taqra wkoll il- fuljett ta ’ tagħrif ta ’ ribavirin.
- if you are allergic to peginterferon-alfa-2a, to any interferon or any of the other ingredients of
- jekk inti allerġiku/ a għall- peginterferon- alfa- 2a, għal xi interferon jew għal sustanzi oħra ta ’
- if you have advanced liver disease (e. g. your skin has become yellow).
- jekk għandek mard avvanzat tal- fwied (eż. il- ġilda tiegħek tkun saret safra).
- if you have diabetes or high blood pressure, your doctor may ask you to have an eye
- jekk għandek tbatidijabete jew pressjoni għolja tad- demm, it- tabib jista ’ jgħidlek biex tagħmel
examination
eżami tal- għajnejn.
- when receiving Pegasys, you may temporarily have a greater risk of getting an infection.
- meta tingħata Pegasys, tista ’ tkun temporanjament f’ riskju ogħla ta ’ infezzjoni.
Check
Tkellem mat- tabib
with your doctor if you think you are getting an infection (such as pneumonia).
jekk taħseb li tkun ser taqbdek infezzjoni (bħal pnewmonja).
- if you develop symptoms associated with a cold or other respiratory infection (such as cough,
- jekk jkollok xi sintomi li jixbħu dawk ta ’ riħ jew ta ’ xi infezzjoni oħra tas- sistema respiratorja (bħal
fever or any difficulty in breathing).
sogħla, deni jew xi diffikultà biex tieħu n- nifs).
- if you develop any signs of bleeding or unusual bruising, check with your doctor immediately.
- jekk ikollok xi sinjali ta ’ telf tad- demm jew ta ’ tbenġil mhux tas- soltu, kellem lit- tabib
- if you have ever had depression or develop symptoms associated with depression (e. g. feelings
- jekk qatt kellek tbatidepressjoni jew tiżviluppa sintomi assoċjati ma ’ depressjoni (eż, sensazzjonijiet
of sadness, dejection etc) while on treatment with Pegasys (see section 4).
ta ’ dwejjaq, niket, etċ) waqt li qiegħed fuq kura b’ Pegasys (ara sezzjoni 4).
- if you are coinfected with HIV and treated with anti HIV medicinal products.
- jekk għandek ukoll HIV u qed tiġi kkurat bi prodotti mediċinali kontra l- HIV.
Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed.
Jekk jogħġbok għarraf lit- tabib jew lill- ispiżjar tiegħek jekk qed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
146 Breast-feeding:
Treddigħ: