qanastek/EMEA-V3 huggingface dataset:
One PegIntron pre-filled pen contains a sufficient amount of peginterferon alfa-2b to provide 100 micrograms in 0.5 ml of peginterferon alfa-2b when reconstituted as recommended.
Pinna mimlija għal- lest ta ’ PegIntron fiha biżżejjed peginterferon alfa- 2b biex tipprovdi 100 mikrogrammi/ 0. 5 ml ta ’ peginterferon alfa- 2b meta din tiġi rikostitwita kif irrakkomandat.
1 pen, 1 injection needle and 2 cleansing swabs 4 pens, 4 injection needles and 8 cleansing swabs 6 pens, 6 injection needles and 12 cleansing swabs 12 pens, 12 injection needles and 24 cleansing swabs 100 micrograms/0.5 ml
pinna 1, labra ta ’ l- injezzjoni u 2 biċċiet biex tnaddaf 4 pinnen, 4 labar ta ’ l- injezzjoni u 8 biċċiet biex tnaddaf 6 pinnen, 6 labar ta ’ l- injezzjoni u 12 biċċiet biex tnaddaf 12 pinnen, 12 labar ta ’ l- injezzjoni u 24 biċċiet biex tnaddaf 100 mikrogrammi/ 0. 5 ml
EU/1/00/131/039 (1 pen, 1 injection needle and 2 cleansing swabs) EU/1/00/131/040 (4 pens, 4 injection needles and 8 cleansing swabs) EU/1/00/131/041 (6 pens, 6 injection needles and 12 cleansing swabs) EU/1/00/131/042 (12 pens, 12 injection needles and 24 cleansing swabs)
EU/ 1/ 00/ 131/ 039 (pinna 1, labra ta ’ l- injezzjoni u 2 biċċiet biex tnaddaf) EU/ 1/ 00/ 131/ 040 (4 pinnen, 4 labar ta ’ l- injezzjoni u 8 biċċiet biex tnaddaf) EU/ 1/ 00/ 131/ 041 (4 pinnen, 4 labar ta ’ l- injezzjoni u 8 biċċiet biex tnaddaf) EU/ 1/ 00/ 131/ 042 (4 pinnen, 4 labar ta ’ l- injezzjoni u 8 biċċiet biex tnaddaf)
PegIntron 100 mcg
PegIntron 100 mkg TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
PegIntron 100 micrograms powder and solvent for solution for injection
PegIntron 100 mikrogrammi trab u solvent għal soluzzjoni għall- injezzjoni
PegIntron 100 micrograms powder and solvent for injection SC
S. C.
260 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
OĦRAJN TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Carton 120 micrograms powder and solvent for solution for injection
Kartuna 120 mikrogrammi trab u solvent għal soluzzjoni għall- injezzjoni
PegIntron 120 micrograms powder and solvent for solution for injection pre-filled pen peginterferon alfa-2b
PegIntron 120 mikrogrammi trab u solvent għal soluzzjoni għall- injezzjoni b’ pinna mimlija għal- lest peginterferon alfa- 2b
One PegIntron pre-filled pen contains a sufficient amount of peginterferon alfa-2b to provide 120 micrograms in 0.5 ml of peginterferon alfa-2b when reconstituted as recommended.
Pinna mimlija għal- lest ta ’ PegIntron fiha biżżejjed peginterferon alfa- 2b biex tipprovdi 120 mikrogrammi/ 0. 5 ml ta ’ peginterferon alfa- 2b meta din tiġi rikostitwita kif irrakkomandat.
1 pen, 1 injection needle and 2 cleansing swabs 4 pens, 4 injection needles and 8 cleansing swabs 6 pens, 6 injection needles and 12 cleansing swabs 12 pens, 12 injection needles and 24 cleansing swabs 120 micrograms/0.5 ml
pinna 1, labra ta ’ l- injezzjoni u 2 biċċiet biex tnaddaf 4 pinnen, 4 labar ta ’ l- injezzjoni u 8 biċċiet biex tnaddaf 6 pinnen, 6 labar ta ’ l- injezzjoni u 12 biċċiet biex tnaddaf 12 pinnen, 12 labar ta ’ l- injezzjoni u 24 biċċiet biex tnaddaf 120 mikrogrammi/ 0. 5 ml
EU/1/00/131/043 (1 pen, 1 injection needle and 2 cleansing swabs) EU/1/00/131/044 (4 pens, 4 injection needles and 8 cleansing swabs) EU/1/00/131/045 (6 pens, 6 injection needles and 12 cleansing swabs) EU/1/00/131/046 (12 pens, 12 injection needles and 24 cleansing swabs)
EU/ 1/ 00/ 131/ 043 (pinna 1, labra ta ’ l- injezzjoni u 2 biċċiet biex tnaddaf) EU/ 1/ 00/ 131/ 044 (4 pinnen, 4 labar ta ’ l- injezzjoni u 8 biċċiet biex tnaddaf) EU/ 1/ 00/ 131/ 045 (4 pinnen, 4 labar ta ’ l- injezzjoni u 8 biċċiet biex tnaddaf) EU/ 1/ 00/ 131/ 046 (4 pinnen, 4 labar ta ’ l- injezzjoni u 8 biċċiet biex tnaddaf)
PegIntron 120 micrograms powder and solvent for solution for injection
PegIntron 120 mikrogrammi trab u solvent għal soluzzjoni għall- injezzjoni
PegIntron 120 micrograms powder and solvent for injection SC
S. C.
263 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
OĦRAJN TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Carton 150 micrograms powder and solvent for solution for injection
Kartuna 150 mikrogrammi trab u solvent għal soluzzjoni għall- injezzjoni
PegIntron 150 micrograms powder and solvent for solution for injection pre-filled pen peginterferon alfa-2b
PegIntron 150 mikrogrammi trab u solvent għal soluzzjoni għall- injezzjoni b’ pinna mimlija għal- lest peginterferon alfa- 2b
One PegIntron pre-filled pen contains a sufficient amount of peginterferon alfa-2b to provide 150 micrograms in 0.5 ml of peginterferon alfa-2b when reconstituted as recommended.
Pinna mimlija għal- lest ta ’ PegIntron fiha biżżejjed peginterferon alfa- 2b biex tipprovdi 150 mikrogrammi/ 0. 5 ml ta ’ peginterferon alfa- 2b meta din tiġi rikostitwita kif irrakkomandat.
1 pen, 1 injection needle and 2 cleansing swabs 4 pens, 4 injection needles and 8 cleansing swabs 6 pens, 6 injection needles and 12 cleansing swabs 12 pens, 12 injection needles and 24 cleansing swabs 150 micrograms/0.5 ml
pinna 1, labra ta ’ l- injezzjoni u 2 biċċiet biex tnaddaf 4 pinnen, 4 labar ta ’ l- injezzjoni u 8 biċċiet biex tnaddaf 6 pinnen, 6 labar ta ’ l- injezzjoni u 12 biċċiet biex tnaddaf 12 pinnen, 12 labar ta ’ l- injezzjoni u 24 biċċiet biex tnaddaf 150 mikrogrammi/ 0. 5 ml
EU/1/00/131/047 (1 pen, 1 injection needle and 2 cleansing swabs) EU/1/00/131/048 (4 pens, 4 injection needles and 8 cleansing swabs) EU/1/00/131/049 (6 pens, 6 injection needles and 12 cleansing swabs) EU/1/00/131/050 (12 pens, 12 injection needles and 24 cleansing swabs)
EU/ 1/ 00/ 131/ 047 (pinna 1, labra ta ’ l- injezzjoni u 2 biċċiet biex tnaddaf) EU/ 1/ 00/ 131/ 048 (4 pinnen, 4 labar ta ’ l- injezzjoni u 8 biċċiet biex tnaddaf) EU/ 1/ 00/ 131/ 049 (4 pinnen, 4 labar ta ’ l- injezzjoni u 8 biċċiet biex tnaddaf) EU/ 1/ 00/ 131/ 050 (4 pinnen, 4 labar ta ’ l- injezzjoni u 8 biċċiet biex tnaddaf)
PegIntron 150 micrograms powder and solvent for solution for injection
PegIntron 150 mikrogrammi trab u solvent għal soluzzjoni għall- injezzjoni
PegIntron 150 micrograms powder and solvent for injection SC
S. C.
PACKAGE LEAFLET
OĦRAJN B.
267 PACKAGE LEAFLET:
FULJETT TA ’ TAGĦRIF FULJETT TA ’ TAGĦRIF:
INFORMATION FOR THE USER
INFORMAZZJONI GĦ AL MIN QED JAGĦ MEL UŻU MINNU
PegIntron 50 micrograms powder and solvent for solution for injection peginterferon alfa-2b (conjugation of recombinant interferon alfa-2b with monomethoxy polyethylene glycol)
PegIntron 50 mikrogrammi trab u solvent għal soluzzjoni għall- injezzjoni peginterferon alfa- 2b (konjugazzjoni ta ’ interferon alfa- 2b rikombinat b’ monomethoxy polyethylene glycol)
- If you have any further questions, ask your doctor or pharmacist.
- Jekk ikollok xi mistoqsijiet, staqsi lit- tabib jew lill- ispiżjar tiegħek.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
- Jekk xi wieħ ed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li m’ humiex
please tell your doctor or pharmacist.
imsemmijin f’ dan il- fuljett, jekk jogħġbok, għ id lit- tabib jew lill- ispiżjar tiegħek.
What PegIntron is and what it is used for 2.
X’ inhu PegIntron u għalxiex jintuża 2.
Before you use PegIntron 3.
Qabel ma tuża PegIntron 3.
How to use PegIntron 4.
Kif għandek tuża PegIntron 4.
How to store PegIntron 6.
Kif taħżen PegIntron 6.
WHAT PEGINTRON IS AND WHAT IT IS USED FOR
X’ INHU PEGINTRON U GĦALXIEX JINTUŻA
Interferons modify the response of the body's immune system to help fight infections and severe diseases.
Interferoni jimmodifikaw ir- rispons tas- sistema immunitarja tal- ġisem fil- ġlieda kontra l- infezzjonijiet u l - mard serju.
PegIntron, which contains an interferon, is used for the treatment of chronic hepatitis C, a viral infection of the liver, including in first time users co-infected with clinically stable HIV.
PegIntron, li fih hemm interferon, jintuża fit- trattament ta ’ l- epatite Ċ kronika, infezzjoni virali tal- fwied, inkluż għal min se jużah l- ewwel darba li jkollu fl- istess ħin marda klinikament stabbli ta ’ l- HIV.
PegIntron is best used for this treatment in combination with ribavirin.
PegIntron l- aħjar li jintuża flimkien ma 'ribavirin għal dan it- trattament.
This combination is indicated in first -time users.
Din it- taħlita hija indikata għal dawk li jkunu ser jużawh għall- ewwel darba.
This combination is also indicated in relapse patients and patients who have not responded previously to interferon alpha (pegylated or nonpegylated) and ribavirin combination therapy or interferon alpha monotherapy.
Din it- taħlita hija indikata wkoll f’ pazjenti li rkadew u f’ pazjenti li ma jkunux urew rispons għal terapija b’ interferon alpha li tkun ingħatat qabel (pegilata jew mhux pegilata) u terapija kombinata b’ ribavirin jew monoterapija b’ alpha interferon.
PegIntron is used alone in case of intolerance or contraindication to ribavirin.
PegIntron jintuża waħdu f’ każ ta ’ intolleranza jew meta ribavirin ikun kontra- indikat.
BEFORE YOU USE PEGINTRON
QABEL MA TUŻA PEGINTRON
PegIntron is not recommended for use in patients under the age of 18 years.
PegIntron mhux rakkomandat għall- użu f’ pazjenti li għ andhom taħt it- 18- il sena.
Do not use PegIntron
Tużax PegIntron
- If you are allergic (hypersensitive) to peginterferon alfa-2b or any of the other ingredients of
- Jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għall- peginterferon alfa- 2b jew sustanzi oħra
PegIntron.
ta ’ PegIntron.
- If you are allergic (hypersensitive) to any interferon.
- Jekk inti allerġiku/ a (sensittività eċċessiva) għal xi interferon.
- If you have had severe heart problems, or if you have heart disease that has not been well controlled
- Jekk kellek problemi serji f’ qalbek, jew jekk għandek mard tal- qalb li ma ġiex kontrollat tajjeb matul
during the past 6 months.
dawn l- aħħar 6 xhur.
- If you have s evere medical conditions that leave you very weak.
- Jekk għandek kundizzjonijeit ta ’ saħħa severi li jħalluk dgħajjef ħafna.
- If you have autoimmune hepatitis or any other problem with your immune system; if you are
- Jekk għandek epatite awto- immuni jew xi problema oħra bis- sistema immunitarja tiegħek, jekk qed
taking medicine that suppresses your immune system (your immune system protects you against infection and some diseases).
tieħu mediċini li jrażżnu s- sistema immunitarja tiegħek (is- sistema immunitarja tiegħek tipproteġik mill- infezzjonijiet u minn xi mard).
- If you have advanced, uncontrolled liver disease (other than hepatitis C).
- Jekk għandek mard fil- fwied avvanzat u mhux ikkontrollat (barra mill- epatite Ċ).
- If you have thyroid disease that is not well controlled with medicines.
- Jekk għandek mard fit- tirojde li mhux taħ t kontroll sew bil- mediċini.
- If you have a condition that causes convulsions (seizures, or “fits”).
- Jekk għandek kundizzjoni li tikkawża konvulżjonijiet (attakki tal- qamar, jew “ aċċessjonijiet ”).
268 Take special care with PegIntron
Oqgħod attent ħafna b 'PegIntron
- If you develop symptoms of a severe allergic reaction (such as difficulty in breathing, wheezing, or
- Jekk tiżviluppa sintomi ta ’ reazzjoni allerġika akuta (bħal diffikultà biex tieħu n- nifs, tħarħir jew
hives) while on this medication, seek medical help immediately.
ħorriqija) waqt li tkun qiegħed fuq din il- medikazzjoni, fittex l- għajnuna medika minnufih.
- If you ever had a heart attack or a heart problem.
- Jekk qatt kellek attakki tal- qalb jew problema fil- qalb.
- If you have ever been treated for depression or any other nervous or mental disorder.
- Jekk qatt ħadt trattament għad- depressjoni jew għal xi problemi oħra tas- sistema nervuża jew mentali.
- If you have kidney disease, your doctor may prescribe a lower than usual dose and monitor your
- Jekk għandek mard tal- kliewi, it- tabib tiegħek jista ’ jordnalek doża aktar baxxa mis- soltu u jeżaminalek
kidney blood values regularly during treatment.
il- valuri tal- kliewi mid- demm b’ mod regolari waqt il- kura.
If you have a kidney disease and you are using PegIntron in combination with medicinal products containing ribavirin, your doctor should monitor you more carefully for a decrease in red blood cell count.
Jekk għandek marda tal- kliewi u qed tuża PegIntron flimkien ma ’ prodotti mediċinali li fihom ribavirin, it- tabib tiegħek għandu jeżaminak aktar bir- reqqa biex jara jekk l- għadd taċ- ċelluli fid- demm ikunx qed jonqos.
- If you have had a problem with your liver (other than hepatitis C).
- Jekk kellek problema bil- fwied tiegħek (barra mill epatite Ċ).
- If you develop symptoms associated with a cold or other respiratory infection, such as fever, cough,
- Jekk tiżviluppa sintomi assoċjati ma ’ riħ jew infezzjoni respiratorja oħra, bħal deni, sogħla, jew xi
or any difficulty in breathing, tell your doctor.
tbatija biex tieħu n- nifs, informa lit- tabib tiegħek.
- If you are diabetic, your doctor may ask you to have an eye examination.
- Jekk inti dijabetiku, it- tabib tiegħek jista ’ jitolbok tagħmel eżami tal- għajnejn.
- If you have had any serious illness affecting your breathing or your blood.
- Jekk kellek mard serju li jaffettwalek in- nifs jew id- demm.
- If you have psoriasis, it may become worse while you are using PegIntron.
- Jekk għandek psorajiżi, tista ’ tmurlek għall- agħar waqt li qed tuża PegIntron.
- If you are planning to become pregnant, discuss this with your doctor before starting to use
- Jekk qed tippjana li toħroġ tqila, iddiskuti dan mat- tabib tiegħek qabel ma tibda tuża PegIntron.
- If you are also being treated for HIV, please see Using other medicines.
- Jekk qed tingħata wkoll trattament għall- HIV, jekk jogħġbok ara Meta tuża mediċini oħra.
- If you have had a severe nervous or mental disorder.
- Jekk kellek mard nervuż jew mentali sever.
- If you ever had depression or develop symptoms associated with depression (e.g. feelings of
- Jekk qatt kont tbati b’ dipressjoni jew tiżviluppa sintomi assoċjati mad- dipressjoni (eż tħoss dwejjaq,
sadness, dejection, etc) while on treatment with PegIntron (see section 4).
jew qalbek sewda, eċċ) waqt li tkun fuq kura bi PegIntron (ara sezzjoni 4).
- If you have received an organ transplant, either kidney or liver, interferon treatment may increase
- Jekk irċevejt trapjant ta ’ organu, jew kliewi jew fwied, kura b’ interferon tista ’ iżżid ir- riskju ta ’ riġett.
Be sure to discuss this with your doctor.
Żgura ruħek li tiddiskuti dan mat- tabib tiegħek.
Dental and gum disorders, which may lead to loss of teeth, have been reported in patients receiving Peg Intron and ribavirin combination therapy.
Mard tas- snien jew tal- ħanek, li jistgħu jwasslu li jaqawlek xi snien, kienu rrappurtati f’ pazjenti li kienu qed jirċievu PegIntron u ribavirin f’ terapija kombinata.
In addition, dry mouth could have a damaging effect on teeth and membranes of the mouth during long -term treatment with the combination of PegIntron with ribavirin.
Minbarra hekk, ħalq xott jista ’ jgħamel il- ħsara fis- snien u l- membrani mukużi tal- ħalq f’ kura fit- tul b’ kombinazzjoni ta ’ PegIntron ma ’ ribavirin.
You should brush your teeth thoroughly twice daily and have regular dental examinations.
Għandek taħsel snienek sew darbtejn kuljum u tmur għal żjarar regolari biex jiġu eżaminati snienek.
If you have this reaction, be sure to rinse your mouth thoroughly afterwards.
Jekk jiġrilek hekk, żgura ruħek li tlaħlaħ ħalqek sew wara.
While being treated with PegIntron Your doctor may want you to drink extra fluids to help prevent low blood pressure.
Waqt li tkun qed tiġi kkurat b’ PegIntron It- tabib tiegħek jista ’ jkun iridek tixrob aktar fluwidi biex jevita li taqalek il- pressjoni.
Using other medicines Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed.
Meta tuża mediċini oħra Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
In studies in pregnant animals, interferons have sometimes caused miscarriage.
Fi studji b’ annimali waqt it- tqala, interferons minn xi daqqiet ikkawżaw korriment.
In combination therapy with ribavirin, ribavirin can be very damaging to an unborn baby, thus both female and male patients must take special precautions in their sexual activity if there is any chance for pregnancy to occur:
F’ terapija kombinata ma ’ ribavirin, ribavirin jista ’ jagħmel ħafna ħsara lit- tarbija mhux imwielda, għalhekk kemm pazjenti nisa kif ukoll l- irġiel għandhom joqgħodu attenti ħafna fl- attivitajiet sesswali tagħhom jekk ikun hemm xi possibilità li sseħħ tqala.
- if you are a girl or a woman of childbearing age, you must have a negative pregnancy test before
- jekk int tfajla jew mara li jista ’ jkollok it- tfal, irid jiġik test negattiv għat- tqala qabel tibda l- kura, kull
treatment, each month during treatment, and for the 4 months after treatment is stopped.
xahar waqt il- kura, u għal- erba ’ xhur wara li twaqqaf il- kura.
You and your partner must each use an effective contraceptive during the time you are taking ribavirin and for 4 months after stopping treatment.
Kemm int kif ukoll sieħbek għandkom tużaw kontraċezzjoni effettiva waqt li tkun qed tieħu ribavirin u għal 4 xhur wara li twaqqaf il- kura.
This can be discussed with your doctor.
Dan jista ’ jiġi diskuss mat- tabib tiegħek.
- if you are a man who is taking ribavirin, do not have sex with a pregnant woman unless you use a
- jekk int raġel li qed tieħu ribavirin, m’ għandekx ikollok x’ taqsam ma ’ mara waqt it- tqala sakemm ma
condom.
tużax kondom.
This will lessen the chance for ribavirin to be left in the woman’s body.
Dan inaqqas ir- riskju li tħalli ribavirin 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 ma tkunx għaddejja minn tqala iżda għadha età li fiha tista ’ toħroġ tqila, għandha tgħamel test tat- tqala kull xahar waqt il- kura u għas- 7 xhur wara li titwaqqaf it- tqala.
If you are a male patient, you and your partner must each use an effective contraceptive during the time you are taking ribavirin and for 7 months after stopping treatment.
Jekk int pazjent raġel, kemm int kif ukoll seħbitek għandkom tużaw kull wieħed kontraċezzjoni effettiva fiż- żmien li tkun qed tieħu ribavirin u għal 7 xhur wara li jitwaqqaf it- trattament.
269 It is not known whether this product is present in human milk.
Mhux magħruf jekk dan il- prodott joħroġx mal- ħalib tal- mara.
Therefore, do not breast-feed an infant if you are taking PegIntron.
Għalhekk, m’ għandekx tredda ’ tarbija jekk qed tieħu PegIntron.
In combination therapy with ribavirin, take notice of the respective informing texts of ribavirin containing medicinal products.
F’ terapija kombinata ma ’ ribavirin, agħti każ ta ’ l- informazzjoni rispettiva li jkun hemm fil- prodotti li jkun fihom ribavirin.
Driving and using machines Do not drive or operate any tools or machines if you feel tired, sleepy or confused while taking PegIntron.
Sewqan u tħaddim ta ’ magni M' għandekx issuq jew tħaddem għodda jew magni jekk tħossok għajjien, bin- ngħas jew imħawwad waqt li qed tieħu PegIntron.
Important information about some of the ingredients of PegIntron This medicinal product contains less than 1 mmol sodium (23 mg) per 0.7 ml, i.e., essentially "sodium-free".
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ PegIntron Dan il- prodott mediċinali fih anqas minn 1 mmol (23 mg) sodium għal kull 0. 7 ml, ie tista ’ titqies “ ħielsa mis- sodium ”.
This medicinal product contains sucrose.
Dan il- prodott mediċinali fih sucrose.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Jekk it- tabib tiegħek qallek li ċerti tipi ta ’ zokkor ma jaqblux miegħek, għamel kuntatt mat- tabib tiegħek qabel tieħu dan il- prodott mediċinali.
Patients who also have HIV infection Lactic acidosis and worsening liver function are side effects associated with Highly Active Anti- Retroviral Therapy (HAART), an HIV treatment.
Pazjenti li għandhom ukoll l- infezzjoni ta ’ l- HIV Aċidożi lattika jew funzjonament tal- fwied li jmur għall- agħar huma effetti sekondarji assoċjati mat - Terapija Anti- Retrovirali Attiva Ħafna (HAART), trattament għall- HIV.
If you are receiving HAART, the addition of PegIntron and ribavirin may increase your risk of lactic acidosis and of liver failure.
Jekk qed tingħata l- HAART, iż - żjieda ta ’ PegIntron u ribavirin jistgħu jżidulek ir- riskju ta ’ l- aċidożi lattika u tal- mard fil- fwied.
Your doctor will monitor you for signs and symptoms of these conditions (Please be sure to read the ribavirin Patient Leaflet also).
It- tabib tiegħek ser iżommok taħt osservazzjoni għal sinjali u sintomi ta ’ dawn il- kundizzjonijiet.
Additionally, patients treated with PegIntron and ribavirin combination therapy and zidovudine could be at increased risk of developing anaemia (low number of red blood cells).
Minbarra hekk, pazjenti ikkurati b’ terapija kombinata ta ’ PegIntron u ribavirin u zidovudine jista ’ jkollhom riskju akbar li jiżviluppaw anemija (numru baxx ta ’ ċelluli ħomor tad- demm).
If you are also being treated for Human Immunodeficiency Virus (HIV) infection (AIDS) with zidovudine or stavudine, it is not certain if ribavirin will change the way these medicines work.
Jekk qed tingħata wkoll kura għall- infezzjoni (AIDS) bil - Vajrus Tal- Bniedem ta ’ L- Immuno- deffiċjenza (HIV) b’ zidovudine jew stavudine, mhux ċar jekk ribavirin jibdilx il- mod kif jaħdmu dawn il- mediċini.
Therefore, your blood will be checked regularly to be sure that the HIV infection is not getting worse.
Għalhekk, id- demm tiegħek ser jiġi eżaminat b’ mod regolari sabiex ikun aċċertat li l- marda ta ’ l- HIV ma tkunx qed tmur għall- agħar.
If it gets worse, your doctor will decide whether or not your ribavirin treatment needs to be changed.
Jekk tmur għall- agħar, it - tabib tiegħek ser jiddeċiedi jekk hemmx bżonn li l- kura tiegħek b’ ribavirin ikollhiex bżonn tinbidel.
Co-administration of ribavirin and didanosine and/or stavudine is not recommended due to the risk of lactic acidosis (a build-up of lactic acid in the body) and pancreatitis.
L- għotja fl- istess ħin ta ’ ribavirin u didanosine u/ jew stavudine mhux irrikkmandat minħabba r- riskju ta ’ aċidożi lattika (jakkumula l- lactic acid fil- ġisem) u pankrejatite.
HOW TO USE PEGINTRON
KIF GĦANDEK TUŻA PEGINTRON
Your doctor has prescribed PegIntron specifically for you and your current condition; do not share this medicine with anyone else.
It- tabib tiegħek kiteb PegIntron speċifikament għalik u għall- kundizzjoni attwali tiegħek; m' għandekx taqsam din il- mediċina ma ’ ħaddieħor.
Your doctor has determined your dose of PegIntron based on your weight.
It- tabib tiegħek stabilixxa d- doża ta ’ PegIntron li int għandek tieħu skond il- piż tiegħek.
If necessary, the dose may be changed during treatment.
Jekk meħtieġ, id - doża tista ’ tinbidel matul it- trattament.
Combination treatment PegIntron, when given with ribavirin capsules, is usually given at a dose of 1.5 microgram/kg once a week.
Trattament Ikkombinat PegIntron, meta mogħti mal- kapsuli ta ’ ribavirin, huwa normalment mogħti f’ doża ta ’ 1. 5 mikrogrammi/ kg darba fil- ġimgħa.
Ribavirin capsules are taken every day, morning and evening.
Il- kapsuli ta ’ ribavirin jittieħdu kuljum, filgħodu u filgħaxija.
The number of ribavirin capsules you take depends on your weight.
In- numru ta ’ kapsuli ta ’ ribavirin li tieħu jiddependi fuq il- piż tiegħek.
- If you weigh less than 65 kg, take 2 capsules in the morning and 2 in the evening (total of
- Jekk tiżen anqas minn 65 kg, għandek tieħu 2 kapsuli filgħodu u 2 filgħaxija (total ta ’ 800 mg
800 mg each day).
kuljum).
- If you weigh between 65 and 85 kg, take 2 capsules in the morning and 3 in the evening (total of
- Jekk tiżen bejn 65 u 85 kg, għandek tieħu 2 kapsuli filgħodu u 3 filgħaxija (total ta ’ 1, 000 mg
1,000 mg each day).
kuljum).
- If you weigh between 86 and 105 kg, take 3 capsules in the morning and 3 in the evening (total
- Jekk tiżen bejn 86 u 105 kg, għandek tieħu 3 kapsuli filgħodu u 3 filgħaxija (total ta ’ 1, 200 mg
of 1,200 mg each day).
kuljum).
- If you weigh more than 105 kg, take 3 capsules in the morning and 4 in the evening (total of
- Jekk tiżen aktar minn 105 kg, għandek tieħu 3 kapsuli filgħodu u 4 filgħaxija (total ta ’ 1, 400 mg
1,400 mg each day).
kuljum).
In first-time users, the combination treatment is continued for 3 to 6 months, and sometimes for one year depending on your physicians judgement.
F’ dawk li jkunu ser jużawh għall- ewwel darba, it- trattament konġunt jitkompla għal 3 sa 6 xhur, u kultant għal sena skond il- ġudizzju tat- tabib tiegħek.
Take notice of the respective informing texts of ribavirin containing medicinal products.
Agħti każ ta ’ l- informazzjoni rispettiva fuq il- prodotti li jkun fihom ribavirin.
For HCV/HIV co-infected patients, the duration of treatment is 48 weeks.
Għall- pazjenti li jkollhom fl- istess ħin HCV/ HIV, il- kura għandha ddum għal 48 ġimgħa.
270 In patients who have not responded previously or relapsed, the treatment should continue for one year (contingent upon the response after the first 12 weeks of therapy).
F’ pazjenti li qabel ma kellhomx rispons jew irkadew, il- kura għadha titkompla għal sena waħda (skond ir - rispons wara l- ewwel 12- il ġimgħa ta ’ terapija).
PegIntron alone:
PegIntron waħdu:
PegIntron, when given alone, is usually given at a dose of 0.5 or 1.0 microgram/kg once a week, for at least 6 months, and possibly for 1 year.
PegIntron, meta mogħti waħdu, huwa normalment mogħti f’ doża ta ’ 0. 5 jew 1. 0 mikrogramma/ kg darba fil- ġimgħa, għal ta ’ l- anqas 6 xhur, u possibilment għal sena 1.
If you have kidney disease, your dose may be lower, depending upon your kidney function.
Jekk għandek marda tal- kliewi, tista ’ tingħatalek doża aktar baxxa skond il- funzjoni tal- kliewi tiegħek.
PegIntron alone was not studied in HCV/HIV co-infected patients.
PegIntron waħdu ma kienx studjat f’ pazjenti li jkollhom infezzjoni fl- istess ħin ta ’ HCV/ HIV.
If you are injecting PegIntron yourself, please be sure that the dose that has been prescribed for you is clearly provided on the package of medicine you receive.
Jekk qed tinjetta PegIntron inti stess, jekk jogħġbok kun ċert illi d- doża li ġiet miktuba lilek hija indikata fuq il- pakkett tal- mediċina li tingħata.
If you have the impression that the effect of PegIntron is too strong or too weak, talk to your doctor or pharmacist.
Jekk tħoss li l- effett ta ’ PegIntron huwa qawwi wisq jew dgħajjef wisq, kellem lit- tabib jew lill- ispiżjar tiegħek.
PegIntron is intended for subcutaneous use.
PegIntron jintuża għal taħt il- ġilda.
This means that it is injected through a short injection needle into the fatty tissue just under your skin.
Dan ifisser illi jiġi injettat permezz ta ’ labra qasira ta ’ l- injezzjoni għal ġot- tessuti tax- xaħam li jinsabu eżatt taħt il- ġilda tiegħek.
If you are injecting this medicine yourself, you will be instructed how to prepare and give the injection.
Jekk inti qed tinjetta din il- mediċina inti stess, inti ser tingħata struzzjonijiet dwar kif tipprepara u tagħti l- injezzjoni.
Detailed instructions for subcutaneous administration are provided with this leaflet (see How to self-inject PegIntron at the end of the package leaflet).
Istruzzjonijiet dettaljati għall- għotja minn taħt il- ġilda huma provduti ma ’ dan il- fuljett (ara Kif tinjetta PegIntron fuqek innifsek fl- aħħar tal - fuljett ta ’ tagħrif).
Prepare the dose just before you intend to inject it and use it immediately.
Ipprepara d- doża eżattament qabel ma tkun bi ħsiebek tinjettaha u użaha immedjatament.
Look carefully at the reconstituted solution prior to administration.
Ħares b’ attenzjoni lejn is- soluzzjoni rikostitwita qabel l- amministrazzjoni.
Do not use if there is discolouration of the reconstituted solution or if particulate matter is present.
Tużax jekk ikun hemm telf tal- kulur tas- soluzzjoni rikostitwita jew jekk ikun fiha xi frak.
Discard any solution that is left in the vial after you give yourself the injection.
Armi kull soluzzjoni li tibqa fil- kunjett wara li tagħti l- injezzjoni lilek innifsek. / PegIntron għandu jintuża darba biss.
Inject PegIntron once each week on the same day.
Injetta PegIntron darba fil- ġimgħa fl- istess jum.
Injecting it at the same time of day each week will help you not to forget to take it.
Li tinjettah fl- istess ħin tal- ġurnata kull ġimgħa jgħinek biex ma tinsiex tieħdu.
Always use PegIntron exactly as your doctor has told you.
Dejjem għandek tuża PegIntron skond il- parir tat- tabib.
Do not exceed the recommended dosage, and take it for as long as prescribed.
Taqbizx id- doża rakkomanda, u ħudu għaż- żmien kif kitiblek it- tabib.
If you use more PegIntron than you should Tell your doctor or healthcare professional as soon as possible.
Jekk tuża PegIntron aktar milli suppost Informa lit- tabib jew professjonista tal- kura tas- saħħa malajr kemm jista ’ jkun.
If you forget to take PegIntron Take the dose as soon as you remember, then continue your treatment as usual.
Jekk tinsa tuża PegIntron Ħu d- doża malli tiftakar, imbagħad kompli it- trattament tiegħek bħas- soltu.
Contact your doctor or pharmacist if needed.
Agħmel kuntatt mat- tabib jew ma ’ l- ispiżjar tiegħek jekk meħtieġ.
Like all medicines, PegIntron can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, PegIntron jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Although not all of these side effects may occur, they may need medical attention if they do.
Għalkemm mhux l- effetti sekondarji kollha jistgħu jseħħu, jista ’ jkollhom bżonn attenzjoni medika jekk iseħħu.
Some people get depressed when taking PegIntron alone or in combination treatment with ribavirin, and in some cases people had suicidal thoughts or aggressive behaviour (sometimes directed against others).
Xi nies taqbadhom dipressjoni meta jkunu qed jieħdu PegIntron waħdu jew f’ kombinazzjoni ma ’ ribavirin, u f’ xi każijiet xi nies kellhom ħsibijiet ta ’ suwiċidju jew imġieba aggressive (kulltant indirizzata lejn l - oħrajn).
Some patients have actually committed suicide.
Xi pazjenti waslu biex għamlu suwiċdju.
Be sure to seek emergency care if you notice that you are becoming depressed or have suicidal thoughts or change in your behaviour.
Żgura ruħek li tikseb kura ta ’ emerġenza jekk qed taqa ’ f’ dipressjoni jew jekk qed tgħamel ħsibijiet ta ’ suwiċidju jew bdilt l- 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.
Jekk trid, tista ’ ssaqsi xi membru tal- familja jew ħabib intimu jgħinek sabiex joqgħod attent għal sinjali ta ’ dipressjoni jew bidliet fl- imġieba tiegħek.
Check with your doctor immediately if any of the following side effects occur: chest pain; changes in the way your heart beats; breathing problems (including shortness of breath), confusion; feeling depressed, wanting to harm yourself, hallucinations, numbness or tingling feeling; dizziness, convulsion ("fit"); trouble sleeping, thinking or concentrating; difficulty remaining alert, severe stomach pain or cramps;
Aċċerta ruħ ek immedjatament mat- tabib tiegħek jekk iseħħ xi wieħed mill- effetti li ġejjin: uġigħ fis- sider; bidliet fil- mod kif tħabbat qalbek; problemi fin- nifs (inkluż qtugħ ta ’ nifs), konfużjoni, tħossok depress, xewqa li tweġġa ’ lilek innifsek, alluċinazzjonijiet, tnemnim jew tingiż; sturdament konvulżjoni (aċċessjoni); tbati biex torqod, taħseb jew tikkonċentra, tbati biex tibqa viġili, uġigħ kbir fl- istonku jew bugħawwieġ; demm jew demm magħqud fl- ippurgar (jew ippurgar iswed qiesu qatran); deni jew dehxiet li jibdew wara ftit ġimgħat ta ’ trattament; uġigħ fin- naħa t’ isfel ta ’ dahrek jew f’ ġenbek; tbati jew ma tkunx tista ’ tgħaddi l - awrina, uġigħ jew infjammazzjoni fil- muskoli (kultant severi); problemi b’ għajnejk jew bil- vista jew is- smigħ; ħmura akuta jew bl- uġigħ fil- ġilda tiegħek jew fir- rita mukuża; tinfaraġ f’ daqqa bil- qawwa.
271 blood or clots in stool (or black, tarry stool); fever or chills beginning after a few weeks of treatment, pain in your lower back or side; difficulty or inability to pass urine, painful or inflamed muscles (sometimes severe); problems with your eyes or your eyesight or hearing; severe or painful reddening of your skin or mucous membrane, severe bleeding from your nose.
It- tabib tiegħek jeżaminalek id- demm sabiex jiżgura illi l- għadd taċ- ċelloli bojod fid- demm (ċelloli li jiġġieldu l- infezzjonijiet) u ċ- ċelloli ħomor fid- demm (ċelloli li jġorru l- ossiġnu), il- plejtlets (ċelloli li jgħinu d- demm biex jagħ qad) u riżultati oħra tal- laboratorju jinsabu f’ livelli aċċettabbli.
Other side effects that may occur with the combination of PegIntron and ribavirin capsules include:
Effetti sekondarji oħrajn li jistgħu jseħħu bil- kombinazzjoni ta ’ PegIntron u l- kapsuli ta ’ ribavirin jinkludu:
Very commonly reported side effects (greater than or equal to 1 in every 10 patients):
Effetti sekondarji komuni ħafna li kienu rrappurtati (aktar jew sa 1 f’ kull 10 pazjenti):
Irritation or redness (and rarely, skin damage) at the site of injection, headache, tired feeling, shaking chills, fever, flu-like symptoms, weakness, loss of weight, nausea, loss of appetite, diarrhoea or loose stools, stomach pain, vomiting, muscle aches, pain in joints and muscles, feeling depressed, irritability, trouble falling asleep or staying asleep, feeling anxious or nervous, difficulty concentrating, mood swings, hair loss, itching, dry skin, sore throat, coughing, difficult breathing, dizziness, virus infection, rash, and dry mouth.
Irritazzjoni u ħmura (u rari ħsara fil- ġilda) fis- sit ta ’ l- injezzjoni, uġigħ ta ’ ras, sensazzjoni ta ’ għejja, dehxiet, deni, sintomi bħal ta ’ l- influwenza, dgħufija, telf ta ’ piż, tqallih, nuqqas ta’ aptit, dijarrea jew ippurgar maħlul, uġigħ fl- istonku, rimettar, weġgħ at fil- muskoli, uġigħ fil- ġogi u fil- muskoli, sensazzjoni ta ’ depressjoni, irritabbilità, problema biex torqod jew tibqa ’ rieqed, sensazzjoni ta ’ ansjetà jew nervużiżmu, diffikultà biex tikkonċentra, bidliet fil- burdati, telf ta ’ xagħar, ħakk, ġilda xotta, uġigħ fil - griżmejn, sogħla, diffikultà biex tieħu n- nifs, sturdament, infezzjoni virali, raxx, u ħalq xott.
Commonly reported side effects (at least 1 in every 100 patients, but less than 1 in every 10 patients):
Effetti sekondarji rrappurtati komuni (mill- anqas 1 f’ kull 100 pazjent, iżda anqas minn 1 f’ kull 10 pazjenti):
Increased sweating, chest pain, pain on the right side around your ribs, numbness, pain or tingling feeling, change in thyroid gland activity (which may make you feel tired or, less commonly, energetic), stomach upset, rapid heart rate, agitation, nervousness, difficult or irregular menstrual period.
Żjieda fl- għaraq, uġigħ fis- sider, uġigħ fuq in- naħa tal- lemin madwar il- kustilji tiegħek, tnemnim, uġigħ jew sensazzjoni ta ’ tingiż, bidla fl- attività tal- glandola tat- tirojde (li tista ’ ġġiegħlek tħossok għajjien jew, anqas komuni, enerġetiku), stonku li mhux f’ postu, taħbit mgħaġġel tal- qalb, aġitazzjoni, nervużiżmu, perijodu ta ’ mestrwali diffiċli jew irregolari.
Less common are pain at the place of injection, flushing, low or high blood pressure, dry or teary eyes, redness of skin or skin disorders, psoriasis, hives, nail disorder, feeling unwell, feeling faint, poor coordination, confusion, increased or decreased sensitivity to touch, tense muscles, arthritis, bruising, loss of interest in activities including sex, sexual problem, unusual dreams, shaky hands, vertigo (spinning feeling), increased appetite, heartburn, intestinal gas (flatus), constipation, hemorrhoids, red or bleeding gums, redness or sores in mouth, change in taste, changes in hearing or ringing in ears, thirst, changed behaviour or aggressive behaviour (sometimes directed against others), feeling sleepy, cold sores, fungal or bacterial infections, irritation of prostate gland, increased need to pass urine, ear or respiratory infections, sinusitis, stuffy or runny nose, abnormal hair texture, sensitivity to sunlight, migraine headache, eye pain or infection, blurred vision, puffy face, puffy hands or feet, enlarged liver, problem affecting ovary or vagina, pain in breast, difficulty in speaking and swollen glands.
Anqas komuni huma l- uġigħ fis- sit ta ’ l- injezzjoni, fwawar, pressjoni baxxa jew għolja, għajnejn xotti jew li jdemmgħu, ħmura fil- ġilda jew mard fil- ġilda, psorajiżi, ħorriqija, problemi fid- dwiefer, sensazzjoni ta ’ ħass ħażin, tħossok debboli, koordinazzjoni fqira, konfużjoni, is- sensittività li tħ oss meta tmiss tiżdied jew tonqos, muskoli iebsin, artrite, tbenġil, nuqqas ta ’ interess f’ attivitajiet li jinkludu s- sess, problema sesswali, ħolm mhux normali, rogħda fl- idejn, vertigo (sensazzjoni li kollox qed idur bik), żjieda fl- aptit, ħruq ta ’ stonku, gass fl- imsaren (tifwiq), stitikezza, emorrojdi, ħanek aħmar jew demmi, ħmura jew ulċeri fil - ħalq, bidla fit- togħma, bidliet fis- smigħ jew tisfir tal- widnejn, għatx, imġieba mibdula jew agressiva (lultant indirizzata lejn l- oħrajn), ngħas, qsim tax- xufftejn, infezzjonijiet b’ fungi jew batteri, irritazzjoni tal- glandola prostata, aktar bżonn li tgħaddi l- awrina, infezzjonijiet fil- widnejn jew respiratorji, sinużite, imnieħer miżdud jew iqattar, kwalità ta ’ xagħar mhux normali, sensittività għad- dawl tax- xemx, uġugħ ta ’ ras b’ emikranja, uġigħ fl- għajnejn jew infezzjoni, vista mċajpra, wiċċ impaħpaħ, tpaħpiħ fl- idejn jew fis- saqajn, fwied imkabbar, problema li taffettwa l- ovarji jew il- vaġina, uġigħ fis- sider, diffikultà biex titkellem, u glandoli minfuħin.
The following rare and very rare events have been reported with PegIntron:
Każijiet rari u rari ħafna li ġejjin kienu rrappurtati bi PegIntron:
Rarely reported side effects (at least 1 in every 10,000 patients, but less than 1 in every 1,000 patients):
Effetti sekondarji irrapurtati rari (mill- anqas 1 f’ 10, 000 pazjent, iżda anqas minn 1 f’ kull 1, 000 pazjent):
Diabetes, abnormal heart rhythm, inflammation of pancreas, inflammation and degeneration of muscle tissue and peripheral nerves, kidney problems and seizures.
Dijabete, tħabbit tal- qalb anormali, infjammazzjoni tal- frixa, infjammazzjoni u diġenerazzjoni tat- tessuti tal- muskoli u nervi periferali, problemi tal- kliewi u aċċessjonijiet.
Very rarely reported side effects (less than 1 in every 10,000 patients):
Effetti sekondarji rrappurtati rari ħafna (anqas minn 1 f’ kull 10, 000 pazjent):
Very rarely sarcoidosis (a disease characterised by persistent fever, weight loss, joint pain and swelling, skin lesions and swollen glands) has been reported.
Rari ħafna kienet rappurtata sarkojdożi (marda karatterizzata minn deni persistenti, telf ta ’ piż, uġigħ fil - ġogi u nefħa, feriti fil- ġilda u glandoli minfuħin).
Loss of consciousness has occurred very rarely with alpha interferons, mostly in elderly patients treated at high doses.
F’ każijiet rari ħafna telf mis- sensi seħħet b’ interferoni alfa, l- aktar f’ pazjenti anzjani ikkurati b’ dożi għoljin.
Cases of stroke (cerebrovascular events) have been reported.
Każijiet ta ’ puplesija (każ ċerebrovaskulari) kienu rrappurtati.
Check with your doctor immediately if you have any of these symptoms or any other symptoms that are troubling.
Aċċerta ruħ ek immedjatament mat- tabib tiegħek jekk għandek xi wieħed minn dawn is - sintomi jew xi sintomi oħrajn li qed jinkwetawk.
Very rarely, PegIntron alone or in combination with ribavirin may cause aplastic anaemia.
Rari ħafna, PegIntron mogħti waħdu jew f’ kombinazzjoni ma ’ ribavirin jista ’ jikkawża anemija aplastika.
Pure red cell aplasia, a condition where the body stopped or reduced the production of red blood cells, has been reported.
Aplażja pura taċ- ċelluli ħomor, kundizzjoni fejn il- ġisem waqaf jew naqqas il- produzzjoni taċ- ċelluli ħomor tad- demm, kienet irrappurtata.
This causes severe anaemia, symptoms of which would include unusual tiredness and a lack of energy.
Din tikkawża anemija severa, li s- sintomi tagħha jinkludu għeja mhux tas- soltu u nuqqas ta ’ saħħa.
272 necrolysis/Stevens Johnson Syndrome/erythema multiforme (a spectrum of rashes with varying degree 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), mania (excessive or unreasonable enthusiasm), bipolar disorders (mood disorders characterized by alternating episodes of sadness and excitement), pericardial effusion (a fluid collection that develops between the pericardium (the lining of the heart) and the heart itself), pericarditis (inflammation of the lining of the heart).
Minbarra hekk, il- każijiet li ġejjin kienu rrappurtati b’ PegIntron: palsi tal- wiċċ (dgħjufija u naħa waħda tal- wiċċ jitgħawweġ) u reazzjonijiet allerġiċi severi bħal anġjoedema (marda allerġika tal- ġilda li l - karatteristika tagħha hija dbabar ta ’ nefħa ċirkomċiża li tinvolvi l- ġilda u s- saffi ta ’ taħtha, il- membrani mukużi, u kultant l- organi interni), nekroliżi tossika ta ’ l- epidermide/ Sindrome ta ’ Stevens Johnson/ erythema multiforme (medda ta ’ raxxijiet b’ gradi varji ta ’ severità inkluża l- mewt li tista ’ tkun assoċjata ma ’ bżieżaq fil- ħalq, imnieħer, għajnejn u membrani mukużi oħrajn u tinqala l- ġilda tal- parti affettwata), manija (entużjażnu eċċessiv jew bla- raġuni), disturbi bipolari (disturbi fil- burdati li l - karatteristika tagħhom hija episodji li jalternaw bejn dwejjaq u eċitament), effużjoni perikardijaka (jinġabar fluwidu bejn il perikardju (rita mad- dawra tal- qalb) u l- qalb innifisha), perikardite (infjammazzjoni tar- rita tal- qalb).
Additionally, Vogt-Koyanagi-Harada syndrome (an autoimmune inflammatory disorder affecting the eyes, skin and the membranes of the ears, brain and spinal cord) has been reported with PegIntron use.
Minbarra hekk, bl- użu ta ’ PegIntron kienet irrappurtata s- sindrome ta ’ Vogt- Koyanagi- Harada (marda awto- immunitarja infjammatorja li teffettwa l- għajnejn, il- ġilda u l- membrani tal- widnejn, moħħ u s - sinsla).
When PegIntron is used alone, some of these effects are less likely to occur, and some have not occurred at all.
Meta PegIntron jintuża waħdu, uħud minn dawn l- effetti huma anqas probabbli li jseħħu, u wħud minnhom ma seħħew qatt.
If you are receiving HAART, the addition of PegIntron and ribavirin may increase your risk of lactic acidosis, liver failure, and development of blood abnormalities (reduction in number of red blood cells which carry oxygen, certain white blood cells that fight infection, and blood clotting cells called platelets).
Jekk qed tirċievu HAART, meta tieħu wkoll PegIntron u ribavirin jista ’ jżidlek ir- riskju li taqbdek aċidożi lattika, insuffiċjenza tal- fwied, u li tiżviluppa anormalitajiet fid- demm (tnaqqis fin- numru ta ’ ċelluli ħomor fid- demm li jġorru l- ossiġnu, ċerti ċelluli bojod li jiġġieldu l- infezzjoni, u ċelluli li huma marbuta mat - tgħaqid tad- demm imsejjħin plejtlits).
The following other side effects (not listed above) have occurred with the combination of PegIntron and ribavirin capsules (adults) in HCV/HIV co-infected patients receiving HAART: oral candidiasis (oral thrush), defective metabolism of fat, CD4 lymphocytes decreased, appetite decreased, back pain, hepatitis, limb pain, and various laboratory blood values abnormalities.
L- effetti sekondarji li ġejjin (mhux elenkati hawn fuq) seħħew bil- kombinazzjoni ta ’ PegIntron u kapsuli ribavirin (adulti) f’ pazjenti ko- infettati b’ HCV/ HIV li kienu qed jirċievu HAART: kandidijasi orali (traxx orali), metaboliżmu tax- xaħam difettuż, tnaqqis fil- limfoċiti CD4, tnaqqis fl- aptit, uġigħ fid- dahar, epatite, uġigħ fir- riġlejn jew driegħ, u anormalitajiet tal- valuri tad- demm varji tal - laboratorju.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Jekk xi wieħ ed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għ id lit- tabib jew lill- ispiżjar tiegħek.
HOW TO STORE PEGINTRON
KIF TAĦŻEN X
Do not use PegIntron after the expiry date which is stated on the carton.
Tużax PegIntron wara d- data ta ’ skadenza li tidher fuq il- kartuna.
After reconstitution, use the reconstituted solution immediately or within 24 hours when stored in a refrigerator (2°C - 8°C).
Wara r- rikostituzzjoni, uża s- soluzzjoni rikostitwita immedjatament jew fi żmien 24 siegħa meta tinħażen f’ temperatura ta ’ bejn 2°C - 8°C (fil- friġġ).
Do not use PegIntron if you notice discolouration of the powder.
Tużax PegIntron jekk tinnota xi telf tal- kulur tat- trab.
The reconstituted solution should be clear and colourless.
Is- soluzzjoni rikostitwita għandha tkun ċara u bla kulur.
Do not use if discolouration or particulate matter is present.
M’ għandekx tużha jekk ikun hemm telf tal- kulur jew xi frak.
Discard any unused material.
Armi kwalunkwe materjal li jibqa.
What PegIntron contains
X’ fih PegIntron
- The active substance is peginterferon alfa-2b, 50 micrograms/0.5 ml.
- Is- sustanza attiva hija peginterferon alfa- 2b, 50 mikrogrammi/ 0. 5 ml.
Powder: disodium phosphate, anhydrous; sodium dihydrogen phosphate dihydrate, sucrose and polysorbate 80; Solvent: water for injections 0.7 ml/ampoule.
Ilma għall- injezzjonijiet 0. 7 ml/ ampulla.
What PegIntron looks like and contents of the pack
Id- Dehra ta ’ PegIntron u l- kontenuti tal- pakkett
The pharmaceutical form is: powder and solvent for solution for injection.
L- għamla farmaċewtika hija: trab u solvent għal soluzzjoni għall- injezzjoni.
The white powder is contained in a 2 ml glass vial and the clear and colourless solvent is presented in a 2 ml glass ampoule.
It- trab abjad qiegħed f’ kunjett tal- ħġieġ ta ’ 2 ml u s- solvent ċar u mingħajr kulur qiegħed f’ ampulla tal - ħġieġ ta ’ 2 ml.
273 PegIntron 50 micrograms is available in different pack sizes:
PegIntron 50 mikrogrammi huwa disponibbli f’ pakketti ta ’ daqsijiet differenti:
- 1 vial of powder for solution for injection, 1 ampoule of solvent for parenteral use, 1 injection
- 1 kunjett ta ’ trab għal soluzzjoni għall- injezzjoni, 1 ampulla ta ’ solvent għall- użu parenterali, 1 siringa
- 6 vials of powder for solution for injection and 6 ampoules of solvent for parenteral use;
- 6 kunjetti ta ’ trab għal soluzzjoni għall- injezzjoni u 6 ampulli ta ’ solvent għall- użu parenterali;
- 12 vials of powder for solution for injection, 12 ampoules of solvent for parenteral use,
- 12- il kunjett ta ’ trab għal soluzzjoni għall- injezzjoni, 12- il ampulla ta ’ solvent għall- użu parenterali,
12 injection syringes, 24 injection needles and 12 cleansing swabs.
12- il siringa għall- injezzjoni, 24 labra ta ’ l- injezzjoni u 12- il biċċa għat- tindif.
Marketing Authorisation Holder and Manufacturer
Id- Detentur ta ’ l- Awtorizzazzjoni għ at- tqegħid fis- Suq u l- Manifattur
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
SP Labo N. V., Industriepark, 30, B- 2220 Heist- op- den- Berg, Il- Belġju Għal kull tagħrif dwar din il- mediċina, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq:
Ireland Shire Park Welwyn Garden City Hertfordshire AL7 1TW Tel: +44-(0)1 707 363 636
Welwyn Garden City Hertfordshire AL7 1TW Tel: +44 - (0) 1 707 363 636
Slovenija Dunajska 22 SI-1000 Ljubljana Tel: + 386 01 3001070
SI- 1000 Ljubljana Tel: + 386 01 3001070
Detailed information on this product is available on the web-site of the European Medicines Agency (EMEA) http://www.emea.europa.eu
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il - Mediċini (EMEA) http: // www. emea. europa. eu /.
275 HOW TO SELF -INJECT PEGINTRON?
KIF TINJETTA PEGINTRON FUQEK INNIFSEK?
The following instructions explain how to inject PegIntron yourself.
L- istruzzjonijiet li ġejjin jispegaw kif tinjetta PegIntron int stess.
Please read the instructions carefully and follow them step by step.
Jekk jogħġbok aqra sew l- istruzzjonijiet u segwihom pass wara pass.
Your doctor or his/her assistant will instruct you how to self- inject PegIntron.
It- tabib tiegħek jew l- assistant tiegħu/ tagħha ser jurik kif injetta PegIntron fuqek innifsek.