qanastek/EMEA-V3 huggingface dataset:
Do not attempt to inject yourself unless you are sure you understand the procedure and requirement of self-injection.
Tippruvax tinjetta lilek innifsek jekk m’ intix ċert li fhimt il- proċedura u x’ inhu meħtieġ biex tinjetta fuek innifsek.
Preparation Collect necessary items before you begin:
Preparazzjoni Iġbor li jkollok bżonn qabel tibda:
- a vial of PegIntron powder for injection;
- kunjett ta ’ tarb ta ’ PegIntron għall- injezzjoni;
- an ampoule of solvent for PegIntron (water for injections);
- ampulla ta ’ solvent għal PegIntron (ilma għall- injezzjonijiet);
- a long needle (for example 0.8 × 40 mm [21 gauge 1.5 inch]) to be used to add water for
- labra twila (per eżempju 0. 8 x 40 mm [21 kalibru ta ’ 1. 5 pulzieri] li tintuża biex iżżid l- ilma għall -
injections to the PegIntron powder vial;
injezzjonijiet lill- kunjett ta ’ PegIntron;
- a short needle (for example 0.3 × 13 mm [30 gauge 0.5 inch]) for the subcutaneous injection;
- labra qasira (per eżempju 0. 3 x 13 mm [30 kalibru ta ’ 0. 5 pulzieri] li tintuża biex tingħata l- injezzjoni
- a cleansing swab.
taħt il- ġilda;
Reconstituting PegIntron powder for injection Before reconstitution, PegIntron may appear either as a white, tablet-shaped solid that is whole or in pieces, or as a white powder.
Rikostituzzjoni ta ’ PegIntron trab għal soluzzjoni Qabel ir- rikostituzzjoni, PegIntron jista ’ jidher bħala solidu abjad f’ għamla ta ’ pillola li hija sħiħa jew imfarrka, jew bħala trab abjad.
Remove the protective cap from the PegIntron vial.
Neħħi l- għatu protettiv mill- kunjett ta ’ PegIntron.
Clean the rubber top of the vial with a cleansing swab.
Naddaf il- lasktu ta ’ fuq bil- biċċa.
You can save the swab to clean the skin area where you will inject the dose.
Tista ’ żżomm il- biċċa biex tnaddaf il- parti tal- ġilda fejn tkun ser tinjetta d- doża.
Do not touch the tip of the syringe.
Tmissx it- tarf tas - siringa.
Take the long needle and place it firmly on to the tip of the syringe.
Ħu l- labra t- twila u qegħdha sew fuq iż- żennuna tas- siringa.
Remove the needle guard without touching the needle and keep the syringe with the needle in your hand.
Neħħi l- kappa tal- labra mingħajr ma tmiss il- labra u żomm is- siringa bil- labra f’ idek.
Tap the top of the ampoule of solvent gently to make sure that all the liquid is at the bottom of the ampoule.
Tektek ħ afif in- naħa ta ’ fuq ta ’ l- ampulla bis- solvent biex taċċerta ruħek li l- likwidu kollu jkun fil- qiegħ ta ’ l- ampulla.
Break off the top of the ampoule of solvent.
Ikser il- parti ta ’ fuq ta ’ l- ampulla tas - solvent.
Insert the needle in the ampoule of solvent and withdraw the total amount of solvent.
Daħħal il- labra fl- ampulla tas- solvent u iġbed l- ammont kollu tas- solvent.
When the total amount of solvent is combined with the full amount of PegIntron powder, the solution will be at the correct concentration to measure your dose (i.e., the labelled amount is contained in 0.5 ml).
Meta l- ammont ta ’ solvent kollu jkun tħallat mat- trab ta ’ PegIntron, is- soluzzjoni jkollha l- konċentrazzjoni tajba biex tkejjel id- doża tiegħek (ie, l- ammont li hemm fuq it- tikketta f’ 0. 5 ml).
A small volume is lost during preparation of PegIntron for injection and when the dose is measured and injected.
Volum żgħir jintilef waqt li tkun qed tħallat PegIntron għall- injezzjoni u meta d- doża titkejjel u tiġi injettata.
Therefore, each vial contains an excess amount of solvent and PegIntron powder to ensure delivery of the labelled dose in 0.5 ml of PegIntron, solution for injection.
Għalhekk, kull kunjett fih aktar solvent u trab PegIntron biex jiżgura li tkun tista ’ tieħu d- doża li hemm fuq it- tikketta f’ 0. 5 ml tas- soluzzjoni PegIntron, soluzzjoni għall- injezzjoni.
To prepare the PegIntron solution, insert the needle through the rubber top of the PegIntron vial and gently place the needle tip against the glass wall of the vial without touching the cleaned top of the vial with your hands.
Biex tipprepara s- soluzzjoni PegIntron, daħħal il- labra mill- lasktu li hemm fuq il- kunjett ta ’ Pegintron u bil- galbu immira t- tarf tal- labra lejn il- ġenb tal- kunjett mingħajr ma tmiss b’ idejk il- lasktu li tkun għadek kif imsaħt bil- biċċa.
Inject the solvent SLOWLY, aiming the stream of liquid at the glass wall of the vial.
BIL- MOD, injetta is- solvent billi timmira l- likwidu lejn il- ġenb tal- ħġieġ tal- kunjett.
It is best not to aim the stream directly at the white solid or powder, or to inject the liquid quickly, as this causes a greater amount of bubbles.
L- aħjar ma timmirax il- likwidu direttament fuq is- solidu jew trab abjad, jew li tinjettha malajr, għax dan jikkawża aktar bżiezaq biex jiffurmaw.
The solution may appear cloudy or bubbly for a few minutes.
Is- soluzzjoni tista ’ tidher mqallba jew bil- bżieżaq għal ftit minuti.
This is to be expected and is not cause for concern.
Dan għandu jkun mistenna u m’ hemmx għalfejn tnkwieta.
To dissolve the entire contents, swirl the PegIntron vial with a gentle rotary motion leaving the needle and attached syringe in the vial.
Biex tħoll il- kontenuti kollha, dawwar il- kunjett ta ’ PegIntron b’ moviment f’ ċirku fil- waqt li tħalli l- labra u s- siringa imwaħħlin fil- kunjett.
Do not shake, but gently turn the vial upside down until any powder at the top of the vial is dissolved.
Tħawwadx, iżda aqleb bil- galbu il- kunjett ta ’ taħt fuq sakemm kwalunkwe trab li jkun hemm fil- parti ta ’ fuq tal- kunjett jinħall.
The contents should now be completely dissolved.
Il- kontenuti issa suppost li jkunu nħallu għall- kollox.
Stand the vial upright and let any bubbles present in the solution rise to the top of the solution.
Żomm il- kunjett wieqaf u ħallih sakemm il- bżieżaq li jista ’ jkun hemm jitilgħu fil- wiċċ tas - soluzzjoni.
Once the solution has settled and all bubbles have risen to the top of the solution, you should have a clear solution with a small ring of tiny bubbles around the top.
Meta s- soluzzjoni toqgħod, għandu jkollok soluzzjoni ċara b’ ċirku żgħir ta ’ bżieżaq żgħar mad- dawra ta ’ fuq.
Now you can withdraw your dose from the vial.
Issa tista ’ tiġbed id- doża tiegħek mill- kunjett.
Use this solution immediately.
Uża din is- soluzzjoni mill- ewwel.
If it cannot be used immediately, the solution may be refrigerated for up to 24 hours.
Jekk ma tkunx tista ’ tintuża mill- ewwel, is- soluzzjoni tista ’ tinżamm fi friġġ sa ’ mhux aktar minn 24 siegħa.
Measuring the dose of PegIntron from the reconstituted powder for injection Turn the vial and the syringe upside down in one hand.
Kif tkejjel id- doża ta ’ PegIntron mit- trab rikostitwit għall- injezzjoni Dawwar il- kunjett u s- siringa bil- maqlub f’ id waħda.
Be sure the tip of needle is in the PegIntron reconstituted solution.
Aċċerta ruħek li l- ponta tal- labra tkun fis- soluzzjoni rikostitwita ta ’ PegIntron.
Pull back on the plunger
L- id l- oħra tkun ħielsa biex timbotta l- planġer.
276 slowly to draw just more than the dose prescribed by your doctor into the syringe.
Iġbed il- planġer bil- mod lura biex tiġbed ftit aktar mid- doża li ordnalek it- tabib fis- siringa.
Hold the syringe with the needle in the vial pointing up, remove the syringe from the long needle leaving the needle in the vial and without touching the tip of the syringe.
Żomm is- siringa bil- labra fil- kunjett tħares ’ l fuq, neħħi s- siringa mill- labra t- twila u ħalli l- labra fil - kunjett mingħajr ma tmiss iż- żennuna tas- siringa.
Take the short needle and place it firmly on to the tip of the syringe.
Aqbad il- labra l- qasira u waħħalha sew fuq iż- żennuna tas- siringa.
Remove the needle guard from the syringe needle and check for air bubbles in the syringe.
Neħħi l- kappa mil- labra tas- siringa u ifli sew biex tara jekk hemmx xi bżieżaq fis- siringa.
If you see any bubbles, pull the plunger slightly back; tap the syringe gently, with the needle pointing upwards, until the bubbles disappear.
Jekk tara xi bżieżaq, iġbed il- planġer ftit lura, tektek is- siringa bil- galbu, u bil- labra tħares ’ l fuq, sakemm il - bżieżaq ma jibqgħux jidhru.
Push up the plunger slowly back to the correct dose.
Imbotta l- planġer bil- mod lura għad- doża t- tajba.
Replace the needle guard and place the syringe with the needle on a flat surface.
Erġa poġġi lura l- kappa tal - labra u poġġi s- siringa fuq superfiċje ċatt
Be sure the solution is at room temperature up to 25°C.
Aċċerta ruħek li s- soluzzjoni tkun ħadet it- temperatura tal- kamra sa ’ 25ºC.
If the solution is cold, warm the syringe between your palms.
Jekk is- soluzzjoni tkun kiesħa, saħħan is- siringa bejn idejk.
Inspect visually the reconstituted solution prior to administration: do not use if discolouration or particulate matter is present.
Ifli sew is- soluzzjoni rikostitwita qabel tgħatiha: tużahiex jekk tara li tilfet il - kulur jew jekk ikun fiha xi frak.
You are now ready to inject the dose.
Issa lest biex tinjetta d- doża.
Injecting the solution Select the injection site.
Kif tinjetta s- soluzzjoni Għażel mnejn se tagħtiha.
The best sites for injection are tissues with a layer of fat between skin and muscle: thigh, outer surface of the upper arm (you may need the assistance of another person to use this site), abdomen (except the navel or waistline).
L- aħjar postijiet għall- injezzjoni huma tessuti li jkun fihom saff ta ’ xaħam bejn il- ġilda u l- muskoli: koxxa, il- parti ta ’ barra tal- parti ta ’ fuq tad- driegħ (jista ’ jkollok bżonn l- għajnuna ta ’ xi ħadd biex tagħtiha hawnhekk), l- addome (minbarra ż- żokra jew il- qadd).
If you are exceptionally thin, use only the thigh or outer surface of the arm for injection.
Jekk int irqieq ħafna, uża biss il- koxxa jew il- parti ta ’ barra ta ’ dirajk għall- injezzjoni.
Change your injection site each time.
Ibdel is- sit mnejn tagħti l- injezzjoni kull darba.
Cleanse and disinfect the skin where the injection is to be made.
Naddaf u ddiżinfetta l- ġilda fejn ser tingħata l- injezzjoni.
Wait for the area to dry.
Stenna sakemm tinxef.
Remove the needle guard.
Neħħi l- kappa tal- labra.
With one hand, pinch a fold of loose skin.
B’ id waħda, oqros saff ta ’ ġilda mbaħbħa.
With your other hand, hold the syringe as you would a pencil.
Bl- id l- oħra, żomm is- siringa qiesek qed iżżomm lapes.
Insert the needle into the pinched skin at an angle of approximately 45°.
Daħħal il- labra fil- ġilda maqrusa f’ angolu ta ’ madwar 45º.
After the needle is in, remove the hand used to pinch the skin and use it to hold the syringe barrel.
Wara lil- labra tkun ġewwa, neħħi l- id li kont qed tuża biex toqros il- ġilda u użaha biex iżżomm it- tubu tas- sringa.
Pull back the plunger very slightly with one hand.
Iġbed lura l- planġer ħafif b’ id waħda.
If blood comes into the syringe, the needle has entered a blood vessel.
Jekk jiġi d- demm fit- tubu tas- siringa jfisser li l- labra daħlet ġo vina.
Do not inject into this site; withdraw the needle and repeat the procedure.
M’ għandekx tinjetta hemmhekk; iġbed il- labra l- barra u erġa għamel il- proċedura mill- ġdid.
Inject the solution by pushing the plunger all the way down gently.
Injetta s- soluzzjoni billi tgħafas il- planġer il- ġewwa għall - kollox.
Pull the needle straight out of the skin.
Iġbed il- labra ’ l barra.
Press the injection site with a small bandage or sterile gauze if necessary for several seconds.
Agħfas is- sit mnejn ingħatat l- injezzjoni b’ xi faxxa żgħira jew garza sterili jekk ikun hemm bżonn għal ftit sekondi.
Do not massage the injection site.
M’ għandekx togħrok il- post mnejn ingħatat l- injezzjoni.
If there is bleeding, cover with an adhesive bandage.
Jekk joħroġ id- demm, għatti b’ faxxa li teħel.
The vial, ampoule and injection materials intended for single use must be discarded.
Il- kunjett, l- ampulla u l- materjali ta ’ l- injezzjoni li qegħdin biex jintużaw darba għandhom jintremew.
Dispose of the syringe and needles safely in a closed container.
Eħles mis- siringa u l- labar b’ mod sigur f’ kontenitur magħluq.
277 PACKAGE LEAFLET:
FULJETT TA ’ TAGĦRIF:
Peg Intron 80 micrograms powder and solvent for solution for injection peginterferon alfa-2b (conjugation of recombinant interferon alfa-2b with monomethoxy polyethylene glycol)
PegIntron 80 mikrogrammi trab u solvent għal soluzzjoni għall- injezzjoni peginterferon alfa- 2b (konjugazzjoni ta ’ interferon alfa- 2b rikombinat b’ monomethoxy polyethylene glycol)
Storing PegIntron 6.
Kif taħżen PegIntron 6.
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.
This combination is indicated in first-time users.
Din it- taħlita hija indikata għal dawk li jkunu ser jużawh għall- ewwel darba.
- If you have had s evere 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
- If you have severe medical conditions that leave you very weak.
- Jekk għandek kundizzjonijeit ta ’ saħħa severi li jħalluk dgħajjef ħafna.
278 Take special care with PegIntron
Oqgħod attent ħafna b 'PegIntron
- If you have psoriasis, it may become worse while you are using Peg Intron.
- Jekk għandek psorajiżi, tista ’ tmurlek għall- agħar waqt li qed tuża PegIntron.
Dental and gum disorders, which may lead to loss of teeth, have been reported in patients receiving PegIntron 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.
279 It is not known whether this product is present in human milk.
Mhux magħruf jekk dan il- prodott joħroġx mal- ħalib tal- mara.
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.
Combination treatment Peg Intron, 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.
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.
280 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).
281 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.
282 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).
- The active substance is peginterferon alfa-2b, 80 micrograms/0.5 ml.
- Is- sustanza attiva hija peginterferon alfa- 2b, 80 mikrogrammi/ 0. 5 ml.
283 PegIntron 80 micrograms is available in different pack sizes:
PegIntron 80 mikrogrammi huwa disponibbli f’ pakketti ta ’ daqsijiet differenti:
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 għ at- tqegħid fis- Suq:
Detailed information on this product is available on the web -site of the Europe an 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 /.
285 HOW TO SELF -INJECT PEGINTRON?
KIF TINJETTA PEGINTRON FUQEK INNIFSEK?
286 slowly to draw just more than the dose prescribed by your doctor into the syringe.
Iġbed il- planġer bil- mod lura biex tiġbed ftit aktar mid- doża li ordnalek it- tabib fis- siringa.
287 PACKAGE LEAFLET:
FULJETT TA ’ TAGĦRIF:
PegIntron 100 micrograms powder and solvent for solution for injection peginterferon alfa-2b (conjugation of recombinant interferon alfa-2b with monomethoxy polyethylene glycol)
PegIntron 100 mikrogrammi trab u solvent għal soluzzjoni għall- injezzjoni peginterferon alfa- 2b (konjugazzjoni ta ’ interferon alfa- 2b rikombinat b’ monomethoxy polyethylene glycol)
288 Take special care with PegIntron
Oqgħod attent ħafna b 'PegIntron
- If you develop symptoms associated with a cold or o ther respiratory infection, such as fever, cough,
- Jekk tiżviluppa sintomi assoċjati ma ’ riħ jew infezzjoni respiratorja oħra, bħal deni, sogħla, jew xi
sadness, dejection, etc) while on treatment with Peg Intron (see section 4).
jew qalbek sewda, eċċ) waqt li tkun fuq kura bi PegIntron (ara sezzjoni 4).
289 It is not known whether this product is present in human milk.
Mhux magħruf jekk dan il- prodott joħroġx mal- ħalib tal- mara.
Your doctor will monitor you for signs and symptoms of these conditions.
It- tabib tiegħek ser iżommok taħt osservazzjoni għal sinjali u sintomi ta ’ dawn il- kundizzjonijiet.
(Please be sure to read the ribavirin Patient Leaflet also).
(Jekk jogħġbok aċċerta ruħ ek li taqra l- Fuljett ta ’ Tagħrif ta ’ ribavirin ukoll).
290 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).
Always use PegIntron exactly as your doctor told you.
Dejjem għandek tuża PegIntron skond il- parir tat- tabib.
291 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.
292 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).
HOW TO STORE PEGINTRON
KIF TAĦŻEN X Żomm fejn ma jintlaħaqx u ma jidhirx mit- tfal.
- The active substance is peginterferon alfa-2b, 100 micrograms/0.5 ml.
- Is- sustanza attiva hija peginterferon alfa- 2b, 100 mikrogrammi/ 0. 5 ml.
293 PegIntron 100 micrograms is available in different pack sizes:
PegIntron 100 mikrogrammi huwa disponibbli f’ pakketti ta ’ daqsijiet differenti:
1 2 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.
SP Labo N.V., Industriepark, 30, B-2220 Heist-op-den-Berg, Belgium
SP Labo N. V., Industriepark, 30, B- 2220 Heist- op- den- Berg, Il- Belġju
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Għal kull tagħrif dwar din il- mediċina, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad- Detentur ta ’ l- Awtorizzazzjoni għ at- tqegħid fis- Suq:
295 HOW TO SELF-INJECT PEGINTRON?
KIF TINJETTA PEGINTRON FUQEK INNIFSEK?
296 slowly to draw just more than the dose prescribed by your doctor into the syringe.
Iġbed il- planġer bil- mod lura biex tiġbed ftit aktar mid- doża li ordnalek it- tabib fis- siringa.
297 PACKAGE LEAFLET:
FULJETT TA ’ TAGĦRIF:
PegIntron 120 micrograms powder and solvent for solution for injection peginterferon alfa-2b (conjugation of recombinant interferon alfa-2b with monomethoxy polyethylene glycol)
PegIntron 120 mikrogrammi trab u solvent għal soluzzjoni għall- injezzjoni peginterferon alfa- 2b (konjugazzjoni ta ’ interferon alfa- 2b rikombinat b’ monomethoxy polyethylene glycol)
- If you have severe medic al conditions that leave you very weak.
- Jekk għandek kundizzjonijeit ta ’ saħħa severi li jħalluk dgħajjef ħafna.
298 Take special care with PegIntron
Oqgħod attent ħafna b 'PegIntron
- If you have had a problem with your liver (o ther than hepatitis C).
- Jekk kellek problema bil- fwied tiegħek (barra mill epatite Ċ).
299 It is not known whether this product is present in human milk.
Mhux magħruf jekk dan il- prodott joħroġx mal- ħalib tal- mara.
Your doctor has determined your dose of Peg Intron based on your weight.
It- tabib tiegħek stabilixxa d- doża ta ’ PegIntron li int għandek tieħu skond il- piż tiegħek.
300 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).
301 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.
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 speakingand 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.
302 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).
- The active substance is peginterferon alfa-2b, 120 micrograms/0.5 ml.
- Is- sustanza attiva hija peginterferon alfa- 2b, 120 mikrogrammi/ 0. 5 ml.
303 PegIntron 120 micrograms is available in different pack sizes:
PegIntron 120 mikrogrammi huwa disponibbli f’ pakketti ta ’ daqsijiet differenti:
- 1 2 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,
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 /.
305 HOW TO SELF-INJECT PEGINTRON?
KIF TINJETTA PEGINTRON FUQEK INNIFSEK?
306 slowly to draw just more than the dose prescribed by your doctor into the syringe.
Iġbed il- planġer bil- mod lura biex tiġbed ftit aktar mid- doża li ordnalek it- tabib fis- siringa.
307 PACKAGE LEAFLET:
FULJETT TA ’ TAGĦRIF:
PegIntron 150 micrograms powder and solvent for solution for injection peginterferon alfa-2b (conjugation of recombinant interferon alfa-2b with monomethoxy polyethylene glycol)
PegIntron 150 mikrogrammi trab u solvent għal soluzzjoni għall- injezzjoni peginterferon alfa- 2b (konjugazzjoni ta ’ interferon alfa- 2b rikombinat b’ monomethoxy polyethylene glycol)
308 Take special care with PegIntron
Oqgħod attent ħafna b 'PegIntron
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.
309 It is not known whether this product is present in human milk.
Mhux magħruf jekk dan il- prodott joħroġx mal- ħalib tal- mara.
Your doctor has prescribed Peg Intron 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.
310 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).
311 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.
312 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).
- The active substance is peginterferon alfa-2b, 150 micrograms/0.5 ml.
- Is- sustanza attiva hija peginterferon alfa- 2b, 150 mikrogrammi/ 0. 5 ml.
313 PegIntron 150 micrograms is available in different pack sizes:
PegIntron 150 mikrogrammi huwa disponibbli f’ pakketti ta ’ daqsijiet differenti:
315 HOW TO SELF-INJECT PEGINTRON?
KIF TINJETTA PEGINTRON FUQEK INNIFSEK?
316 slowly to draw just more than the dose prescribed by your doctor into the syringe.
Iġbed il- planġer bil- mod lura biex tiġbed ftit aktar mid- doża li ordnalek it- tabib fis- siringa.
317 PACKAGE LEAFLET:
FULJETT TA ’ TAGĦRIF:
PegIntron 50 micrograms powder and solvent for solution for injection in pre-filled pen Peginterferon alfa-2b (conjugation of recombinant interferon alfa-2b with monomethoxy polyethylene glycol)
PegIntron 50 mikrogrammi trab u solvent għal soluzzjoni għall- injezzjoni għall- pinna mimlija għal- lest peginterferon alfa- 2b (konjugazzjoni ta ’ interferon alfa- 2b rikombinat b’ monomethoxy polyethylene glycol)
- If you have h ad 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
318 Take special care with PegIntron
Oqgħod attent ħafna b 'PegIntron
319 It is not known whether this product is present in human milk.
Mhux magħruf jekk dan il- prodott joħroġx mal- ħalib tal- mara.
320 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).
Detailed instructions for subcutaneous administration are provided with this leaflet (see How to use the PegIntron pre-filled pen).
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).
PegIntron is intended for single use only.
Armi kull soluzzjoni li tibqa fil- kunjett wara li tagħti l- injezzjoni lilek innifsek. / PegIntron għandu jintuża darba biss.
Thus, after you give yourself the injection, discard the PegIntron pre-filled pen with any solution that is left in it.
Għalhekk wara li tagħti l- injezzjoni lilek innifsek, armi l- pinna mimlija għal- lest ta ’ PegIntron b’ kwalunkwe soluzzjoni li jista ’ jkun għad fiha.
Like all medicines, PegIntron can cause side effects, although not everybody gets them.
EFFETTI SEKONDARJI LI JISTA ’ JKOLLU Bħal kull mediċina oħra, PegIntron jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
321 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.
Less common are pain at the place of injection, flushing, low or high blood pressure, dry or teary eyes, redness of skin or skin disorder, 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.
322 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).
After administering the dose, discard the PegIntron pre -filled pen and any unused solution contained in it.
Armi kwalunkwe materjal li jibqa.
Powder: disodium phosphate, anhydrous; sodium dihydrogen phosphate dihydrate, sucrose and polysorbate 80; Solvent: water for injections
Trab: disodium phosphate, anhydrous; sodium dihydrogen phosphate dihydrate, sukrożju u polysorbate 80.; Solvent: ilma għall- injezzjoni.
The pharmaceutical form is: powder and solvent for solution for injection in a pre-filled pen.
L- għamla farmaċewtika hija: trab u solvent għal soluzzjoni għall- injezzjoni għall- pinna mimlija għal- lest.
323 The white powder and the clear and colourless solvent are both contained in a two-chamber glass cartridge assembled into a single use pre-filled pen.
It- trab abjad u s- solvent ċar u mingħajr kulur it- tnejn jinsabu ġo skartoċċ tal- ħġieġ b’ żewġ kompartimenti imdaħħal ġo pinna mimlija għal- lest li tintuża darba biss.
PegIntron 50 micrograms is available in different pack sizes:
PegIntron 50 mikrogrammi huwa disponibbli f’ pakketti ta ’ daqsijiet differenti:
- 1 pen containing powder and solvent for solution for injection, 1 injection needle and 2 cleansing
- 1 pinna li fiha trab u solvent għal soluzzjoni għall- injezzjoni, 1 labra ta ’ l- injezzjoni u 2 biċċiet għat -
swabs;
tindif;
- 4 pens containing powder and solvent for solution for injection, 4 injection needles and 8 cleansing
- 4 pinen li fihom trab u solvent għal soluzzjoni għall- injezzjoni, 4 labriet ta ’ l- injezzjoni u 8 biċċiet għat -
- 6 pens containing powder and solvent for solution for injection, 6 injection needles
- 6 pinen li fihom trab u solvent għal soluzzjoni għall- injezzjoni, 6 labriet ta ’ l- injezzjoni u 12- il biċċa
and 12 cleansing swabs;
għat- tindif;
- 12 pens containing powder and solvent for solution for injection, 12 injection needles
- 12- il pinna li fihom trab u solvent għal soluzzjoni likwida għall- injezzjoni, 12- il labra ta ’ l- injezzjoni
and 24 cleansing swabs.
u 24 biċċa għat- tindif.
Marketing Authorisation Holder:
Id- Detentur ta ’ l- Awtorizzazzjoni għ at- tqegħid fis- Suq u l- Manifattur Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq:
325 ANNEX TO THE PACKAGE LEAFLET
ANNESS GĦALL- FULJETT TA ’ TAGĦ RIF
How to use the PegIntron pre-filled pen
Kif tuża l- pinna mimlija lesta ’ ta ’ PegIntron
The following instructions explain how to inject yourself with the single use PegIntron pre-filled pen.
L- istruzzjonijiet li ġejjin jispjegaw kif għandek tinjetta lilek innifsek bil- pinna mimlija lesta ta ’ PegIntron li tintuża darba biss.
Please read all of the instructions carefully before attempting to use the pen and follow them step by step.
Jekk jogħġbok aqra l- istruzzjonijiet kollha bil- mod qabel ma tipprova tuża l - pinna u segwihom pass pass.
Your doctor or his/her assistant will show you how to self-inject with the PegIntron pre-filled pen.
It- tabib jew spiżjar tiegħek ser jurik kif tinjetta lilek innifsek bil- pinna mimlija lesta ta ’ PegIntron.
Do not attempt to inject yourself unless you are sure you understand everything fully.
Tippruvax tinjetta lilek innifsek sakemm ma tkunx ċert illi qed tifhem kollox.
The PegIntron pre-filled pen should be used by one person only and must not be shared.
Il- pinna mimlija lesta ’ ta ’ PegIntron għandha tintuża minn persuna waħda biss u m’ għandhiex tkun mislufa.
Use the injection needle and cleansing swabs provided in the pack only for the PegIntron pre-filled pen.
Uża l- labra ta ’ l- injezzjoni u l- biċċiet għat- tindif provduti fil- pakkett biss għall- pinna mimlija għal- lest ta ’ PegIntron.
Make sure that the pen is at room temperature before you use it.
Aċċerta ruħek illi l- pinna tinsab f’ temperatura tal- kamra fil- ħin ta ’ l- injezzjoni qabel tużha.
Your doctor will have told you what dose you need to take for your treatment.
It- tabib tiegħek ser ikun qallek x’ doża għandek bżonn tieħ u għal- kura tiegħek.
The colour of the dosing button is different for each strength of the PegIntron pre-filled pen.
Il- kulur tal- buttuna tad- dożaġġ hija differenti għal kull qawwa tal- pinna mimlija għal- lest ta ’ PegIntron.
Preparation: a.
Preparazzjoni: a.
Find a clean, well-lit, non-slip flat working surface and get together all of the supplies you will need for the injection.
Sib post nadif, imdawwal sew, li ma jiżloqx u pjan u ġib l- affarjiet kollha li se jkollok bżonn għ all - injezzjoni.
All of the supplies you will need are in the PegIntron pack.
Il- pakkett fih:
The pack contains: • PegIntron pre-filled pen • one disposable injection needle • two cleansing swabs, and • dosing tray b.
PegIntron pinna mimlija għal- lest Labra waħ da għall- injezzjoni li tintuża darba u tintrema Żewġ biċċiet għat- tindif, u Trej għad- dożaġġi
The PegIntron pre-filled pen should be stored in the refrigerator, but take it out and allow it to come to room temperature before you use it.
Il- pinna mimlija għal- lest ta ’ PegIntron għandha tinħażen fil- friġġ, iżda oħroġha u ħalliha tilħaq it - temperatura tal- kamra qabel tużha.
Before taking the PegIntron pre-filled pen out of its carton, check the expiration date printed on the carton.
Qabel toħroġ il- pinna mimlija għ al- lest ta ’ PegIntron mill - kartuna tagħha, ikkontrolla d- data ta ’ skadenza ittimbrata fuq il- kartuna.
Do not use if the expiration date has passed. c Take the PegIntron pre-filled pen out of the carton.
Oħroġ il- pinna mimlija għal- lest ta ’ PegIntron mill- kartuna.
Look in the window of the pen and make sure there is a white, to off-white tablet that is whole, or in pieces, or powdered.
Ittawwal mit- twejqa tal- pinna u aċċerta ruħek li hemm pillola bajda, tagħti fl- off- wajt li hi sħiha, imfarrka, jew fi trab.
This is the PegIntron which will be mixed with liquid inside the pen before it is injected. d.
Dan huwa il - PegIntron li se jitħallat mal- likwidu fil- pinna qabel ma tiġi injettata. d.
Wash your hands thoroughly with soap and water, rinse, and towel dry.
Aħsel idejk sew bis- sapun u bl- ilma, laħlaħ, u ixxotta b’ xugaman.