qanastek/EMEA-V3 huggingface dataset:
In combination therapy with ribavirin, take notice of the respective informing texts of ribavirin containing medicinal products.
147 F’ terapija kombinata ma ’ ribavirin, ara l- fuljetti ta ’ tagħrif rispettivi tal- prodotti mediċinali li fihom ribavirin.
May cause toxic reactions and allergic reactions in infants and children up to 3 years old
Jista ’ jikkawża reazzjonijiet tossiċi u allerġiċi fi trabi u tfal ta ’ età ta ’ mhux aktar minn 3 snin.
Pegasys dosing Your doctor has determined the exact dose of Pegasys, and will tell you how often to use it.
Dożżaġġ ta ’ Pegasys It- tabib iddetermina id- doża eżatta ta ’ Pegasys li għandek tieħu, u ser jgħidlek kemm il- darba trid tużah.
Pegasys given alone or in combination with ribavirin is usually given at a dose of 180 micrograms once a week.
Pegasys mgħoti waħdu jew ikkombinat ma ’ ribavirin huwa ġeneralment mgħoti f’ doża ta ’ 180 mikrogrammi darba fil- ġimgħa.
Please check with your doctor and follow the recommended duration of treatment.
Jekk joġgħbok aċċerta ruħek mat- tabib tiegħek u ħu l- kura għall- perijodu ta ’ żmien irrakkomandat.
Pegasys is intended for subcutaneous use (under the skin).
Pegasys huwa maħsub għall- użu minn taħt il- ġilda (għal taħt il- ġilda).
If you are injecting this medicine yourself, you will be instructed how to give the injection.
Jekk tkun ser tinjetta din il- mediċina inti stess, ser tingħata struzzjonijiet kif għandek tagħti l- injezzjoni..
Detailed instructions are provided at the end of this leaflet (see “ How to self-inject Pegasys”).
Istruzzjonijiet dettaljati huma provduti fl- aħħar ta ’ dan il- fuljett (ara “ Kif tinjetta lilek innifsek b' Pegasys ”).
Use Pegasys exactly as described by your doctor, for as long as prescribed by your doctor If you have the impression that the effect of Pegasys is too strong or too weak, talk to your doctor or pharmacist.
Jekk tħoss li l - effett ta ’ Pegasys huwa qawwi wisq jew dgħajjef wisq, kellem lit- tabib jew spiżjar tiegħek.
Contact your doctor or pharmacist as soon as possible.
Tkellem lit- tabib jew spiżjar tiegħek immedjatament.
If you realise you missed your injection 1 or 2 days after it was scheduled, you should inject your recommended dose as soon as possible.
Jekk tinduna li nsejt tieħu l- injezzjoni tiegħek ġurnata jew jumejn wara li suppost, għandek tinjetta id - doża rakkomandata tiegħek immedjatament.
If you realise you missed your injection 3 to 5 days after it was scheduled, you should take your injection at the recommended dose as soon as possible.
Jekk tinduna li nsejt tieħu l- injezzjoni tiegħek tlett ijiem sa ħamest ijiem wara li suppost, għandek tinjetta id- doża rakkomandata tiegħek immedjatament.
You remember on Friday that you forgot to take your injection on Monday (4 days late). You should inject your regularly scheduled dose immediately on Friday and take your next injection on Wednesday (5 days after your Friday dose).
Għandek tinjetta d- doża tas - soltu tiegħek immedjatament il- Ġimgħa u ħu l- injezzjoni ta ’ wara l- Erbgħa (ħamest ijiem wara d- doża tal- Ġimgħa).
Your next injection will be on the Monday, 5 days later after
L- injezzjoni li jmiss ser tkun it- Tnejn, ħamest ijiem wara l- injezzjoni ta ’ l - Erbgħa.
You are now back on your regularly scheduled day and should continue your injections every Monday.
Issa erġajt lura għall- ġurnata tas- soltu tiegħek u għandek tkompli l- injezzjonijiet tiegħek kull nhar ta ’ Tnejn.
If you realise you missed your injection 6 days after it was scheduled, you should wait and take your dose on the next day, your regularly scheduled day.
148 Jekk tinduna li nsejt tieħu l- injezzjoni tiegħek sitt ijiem wara li suppost, għandek tistenna u tieħu d- doża l- ġurnata ta ’ wara, il- ġurnata tas- soltu.
Contact your doctor or pharmacist if you need any help determining how to manage a missed dose of Pegasys.
Kellem lit- tabib jew lill- ispiżjar tiegħek jekk għandek bżonn xi għajnuna dwar x’ għandek tagħmel meta tinsa tieħu doża ta ’ Pegasys.
Like all medicines, Pegasys can cause side effects, although not eveybody gets them.
Bħall kull mediċina oħra, Pegasys jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
During treatment your doctor will take blood samples regularly to check for changes in your white blood cells (cells that fight infection), red blood cells (cells that carry oxygen), platelets (blood clotting cells), liver function or changes in other laboratory values.
Waqt il- kura it- tabib tiegħek ser jieħu regolarment kampjuni tad- demm sabiex jiċċekkja għal xi tibdiliet fiċ- ċelloli bojod tad- demm tiegħek (ċelloli li jiġġieldu l- infezzjoni), fiċ- ċelloli ħomor tad- demm (ċelloli li jġorru l- ossiġnu), fil- plejtlits (ċelloli li jgħaqqdu d- demm), fil- funzjoni tal- fwied jew tibdiliet f’ valuri oħra tal- laboratorju.
148 Nervous system disorders:
149 Disturbi fl- għajnejn:
Vomiting, indigestion, difficulty swallowing, mouth ulceration, bleeding gums, inflammation of tongue and mouth, flatulence (excess amount of air or gases), dry mouth and loss of weight Skin disorders:
Disturbi fil- ġilda:
Rash, increased sweating, psoriasis, hives, eczema, sensitivity to sunlight, night sweats Musculoskeletal disorders:
Raxx, żieda fl- għaraq, psorjażi, ħorriqija, ekżema, sensittività għad- dawl tax- xemx, tgħereq ħafna matul il- lejl Disturbi muskolu- skeletrali:
Diabetes (high blood sugar) Metabolic disorders:
Dijabete (zokkor għoli fid- demm) Disturbi metaboliċi:
High blood pressure Respiratory diosorders:
Pressjoni għolja Disturbi respiratorji:
Diabetic ketoacidosis, a complication of uncontrolled diabetes Psychiatric disorders:
Ketoaċidożi dijabetika, komplikazzjoni ta ’ dijabete mhux ikkontrollata Disturbi psikjatriċi:
Bleeding in the brain and inflammation in the vessels.
Fsada fil- moħħ u infjammazzjoni fil- kanali.
Respiratory disorders:
150 Disturbi respiratorji:
Interstitial pneumonia (inflammation of the lungs including fatal outcome), blood clots in the lung
Pnewmonja interstizjali (infjammazjoni tal- pulmun inkluż riżultat fatali), demm magħqud fil- pulmun Disturbi gastro- intestinali:
149 Gastrointestinal disorders: stomach ulcer, inflammation of the pancreas Liver disorders:
Ulċera fl- istonku, infjammazzjoni tal- frixa Disturbi fil- fwied:
When Pegasys is used alone in hepatitis B or C patients, some of these effects are less likely to occur.
Meta Pegasys jkun użat waħdu f’ pazjenti b’ epatite B jew Ċ, xi wħud minn dawn l- effetti għandhom anqas probabbilità li jseħħu.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.
Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew spiżjar tiegħek.
What Pegasys contains
X’ fih Pegasys
with bis-[monomethoxy polyethylene glycol] of a molecular mass, Mn, of 40 000), 180 micrograms in a single dose vial.
[monomethoxy polyethylene glycol] ta ’ massa molekulari, Mn, ta ’ 40, 000.), 180 mikrogramma f’ kunjett ta ’ doża waħda.
150 What Pegasys looks like and contents of the pack
Id- Dehra ta ’ Pegasys u l- kontenuti tal- pakkett
Österreich Roche Austria GmbH Tel: +43 (0) 1 27739
152 Polska Ελλάδα Roche Polska Sp. z o. o.
HOW TO SELF-INJECT PEGASYS
KIF TINJETTA PEGASYS LILEK INNIFSEK
Please read the instructions carefully and follow them step by step.
Jekk jogħġbok aqra l- istruzzjonijiet b’ attenzjoni u segwihompass pass.
Getting Ready
Preparamenti
- a cleansing swab
153
● Remove the needle guard without touching the needle and keep the syringe with the needle in your hand. ● Insert the needle through the rubber top of the Pegasys vial (3).
Neħħi l- għatu tal- labra mingħajr ma tmiss il- labra u żomm is- siringa bil- labra f’ idejk. ● Daħħal il- labra minn ġol- wiċċ tal- gomma tal- kunjett ta’ Pegasys (3). ●
● Hold the vial and syringe in one hand and turn the vial and the syringe upside down (4).
Żomm il - kunjett u s- siringa f’ id waħda u dawwar il- kunjett u s- siringa ta ’ taħt fuq (4). ●
With the syringe pointing up, make certain that the tip of the needle is in the Pegasys solution.
Bis- siringa tipponta ’ l fuq, kun ċert li t- tarf tal- labra jkun fit- soluzzjoni ta ’ Pegasys.
Your other hand will be free to move the plunger of the syringe.
L- id l- oħra tkun ħielsa biex tmexxi il- planġer tas- siringa. • Iġbed il- planġer lura bil- mod sabiex tiġbed fis- siringa ftit aktar mid- doża li nkitbitlek mit- tabib.
153 ● Slowly pull back the plunger to withdraw a bit more than the dose prescribed by your doctor into the syringe. ● Hold the syringe with the needle in the vial pointing up, remove the syringe from the long needle while keeping the needle in the vial and without touching the tip of the syringe. ● Take the short needle and place it firmly on to the tip of the syringe (5).
Ħu l- labra l- qasira u waħħalha sew mal- ponta tas- siringa (5). ●
● Remove the needle guard from the syringe needle. ● Check for air bubbles in the syringe.
Neħħi l- għatu tal- labra mil- labra tas- siringa. ● Iċċekkja għal xi bżieżaq ta ’ l- arja fis- siringa.
If you see any bubbles, pull the plunger slightly back.
Jekk tara xi bżieżaq, iġbed ftit lura l- planġer.
To remove air bubbles from the syringe, hold the syringe with the needle pointing up.
Biex ● tneħħi xi bżieżaq ta ’ l- arja minn ġos- siringa, żomm is- siringa bil- labra tipponta ’ l fuq.
Tap the syringe gently to bring the bubbles to the top.
Tektek is - siringa bil- mod sabiex il- bżieżaq jitilgħu fil- parti ta ’ fuq.
Push the plunger up slowly to the correct dose.
Imbotta bil- mod il- planġer ’ l fuq bil - mod sad- doża t- tajba.
Replace the needle guard and place the syringe in a horizontal position until ready for use. ● Allow the solution to reach room temperature before injection or warm the syringe between your palms. ● Visually inspect the solution prior to administration: do not use if it is discoloured or if particles are present.
Ispezzjona viżwalment is- soluzzjoni qabel l- għotja: tużahiex jekk jkollha kulur mhux tas- soltu ● jew jekk ikun fiha xi frak.
Injecting the solution
Injezzjoni tat- soluzzjoni
With your other hand hold the syringe as you would a pencil. ● Insert the needle all the way into the pinched skin at an angle of 45° to 90° (6).
Daħħal il- labra kollha fil- ġilda maqrusa b’ anglu ta ’ 45° sa 90° (6). ●
● Inject the solution by gently pushing the plunger all the way down. ● Pull the needle straight out of the skin. ● Press the injection site with a small bandage or sterile gauze if necessary for several seconds.
155 Injetta t- soluzzjoni billi timbotta bil- mod il- planġer s’ isfel nett. ● Iġbed il- labra ’ l barra mill- ġilda. ● Jekk hemm bżonn għafas għal ftit sekondi l- post fejn tajt l- injezzjoni b’ biċċa faxxa żgħira jew ● b’ garża sterili.
Ask your doctor, hospital or pharmacist for an appropriate container.
Staqsi lit- tabib, sptar jew lill- spiżjar tiegħek għal kontenitur xieraq.
154 PACKAGE LEAFLET:
156 FULJETT TA ’ TAGĦRIF:
Pegasys 135 micrograms solution for injection in pre-filled syringe Peginterferon alfa-2a
Pegasys 135 mikrogramma soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest Peginterferon alfa- 2a
How to storePegasys 6.
Kif taħżen Pegasys 6.
If you receive combination therapy of Pegasys and ribavirin, you should also read the ribavirin package leaflet.
Jekk ser tingħata terapija kombinata ta ’ Pegasys u ribavirin, għandek taqra wkoll il- fuljett ta ’ ribavirin.
Tell your doctor:
Ghid lit- tabib:
- if you have diabetes or high blood pressure, your doctor may ask you to have an eye
- jekk għandek dijabete jew pressjoni għolja tad- demm, it- tabib jista ’ jgħidlek biex tagħmel eżami
examination.
tal- għajnejn.
- if you develop symptoms associated with a cold or other respiratory infection (such as cough,
- jekk ikollok xi sintomi li jixbħu dawk ta ’ riħ jew ta ’ xi infezzjoni oħra tas- sistema respiratorja (bħal
fever or any difficulty in breathing).
sogħla, deni jew xi diffikulta biex tieħu n- nifs).
- if you have ever had depression or develop symptoms associated with depression (e. g. feelings
- jekk qatt kellek depressjoni jew tiżviluppa sintomi assoċjati ma ’ depressjoni (eż, sensazzjonijiet ta ’
156 Breast-feeding:
Treddigħ:
In combination therapy with ribavirin, take notice of the respective informing texts of ribavirin containing medicinal products.
158 F’ terapija kombinata ma ’ ribavirin, ara l- fuljetti ta ’ tagħrif rispettivi tal- prodotti mediċinali li fihom ribavirin.
You should check with your doctor or pharmacist if you are not sure.
Dejjem għandek taċċerta ruħek mat- tabib jew ma ’ l- spiżjar tiegħek jekk ikollok xi dubju.
Pegasys is intended for subcutaneous use (under the skin).
Pegasys huwa intiż għall- użu ta ’ taħt il- ġilda.
This means that Pegasys is injected with a short needle into the fatty tissue under the skin in the abdomen or thigh.
Dan ifisser li Pegasys huwa injettat b’ labra qasira fit - tessut xaħmi ta ’ taħt il- ġilda fl- addominali jew fil- koxxa.
If you are injecting this medicine yourself, you will be instructed how to give the injection.
Jekk tkun ser tinjetta din il- mediċina inti stess, int ser tiġi muri kif tagħti l- injezzjoni.
If you realise you missed your injection 6 days after it was scheduled, you should wait and take your dose on the next day, your regularly scheduled day.
159 Jekk tinduna li nsejt tieħu l- injezzjoni tiegħek sitt ijiem wara li suppost, għandek tistenna u tieħu d- doża l- ġurnata ta ’ wara, il- ġurnata tas- soltu.
Contact your doctor or pharmacist if you need any help determining how to manage a missed dose of Pegasys.
Kellem lit- tabib jew lill- spiżjar tiegħek jekk għandek bżonn xi għajnuna dwar x’ għandek tagħmel meta tinsa tieħu doża ta ’ Pegasys.
Tell your doctor immediately if you notice any of the following side effects: severe chest pain; persistent cough; irregular heartbeat; trouble breathing; confusion; depression; severe stomach pain; blood in stool (orblack, tarry stools); severe nosebleed; fever or chills; problems with your eyesight.
Għarraf lit- tabib tiegħek immedjatament jekk tinnota xi wieħed minn dawn l- effetti sekondarji: uġigħ qawwi fis- sider; sogħla persistenti; qalb tħabbat b’ mod irregolari; diffikultà biex tieħu n- nifs; konfużjoni; depressjoni; uġigħ ta ’ żaqq qawwi; demm fl- ippurgar (jew ippurgar iswed, qisu qatran); fsada qawwija mill- imnieħer; deni jew rogħda ta ’ bard; problemi fil- vista tiegħek.
Mood / emotion changes, aggression, nervousness, decreased sexual desire Nervous system disorders:
Tibdil fil- burata/ emozzjonali, aggressjoni, nervi, tnaqqis fix- xewqa sesswali Disturbi fis- sitema nervuża:
Poor memory, fainting, decreased muscle strength, migraine, numbness, tingling, burning sensation, tremor, changes in the sense of taste, nightmares, sleepiness Eye Disorders:
Memorja ħażina, ħass ħażin, tnaqqis tas- saħħa fil- muskoli, emigranja, tnemnim, tingiż, sensazzjoni ta ’ ħruq, rogħda, tibdil fis- sens tat- togħma, inkubi, ngħas
158 Ear disorders:
Disturbi fil- widnejn:
Flushing Respiratory disorders: shortness of breath with activity, nose bleeds, nose and throat inflammation, infections of the nose and sinuses (air-filled spaces found in the bones of the head and face), runny nose, sore throat.
Fwawar Disturbi respiratorji: qtugħ ta ’ nifs ma ’ l- attività, fsada mill- imnieħer, infjammazzjoni fl- imnieħer u fil - griżmejn, infezzjonijiet fl- imnieħer u fis- sinus (spażji mimlijin bl- arja li jinstabu fl- għadam tar- ras u tal - wiċċ), imnieħer iqattar, uġigħ fil- griżmejn
Infection of the heart, infection of the external ear Blood disorders: severe reduction in red blood cells, white blood cells and platelet Immune system disorders:
Disturbi tad- demm: tnaqqis qawwi taċ- ċelluli l- ħomor tad- demm, taċ- ċelluli l- bojod tad- demm u tal - plejtlits Disturbi fis- sistema immuni:
Diabetic ketoacidosis, a compilation of uncontrolled diabetes Psychiatric disorders:
Ketoaċidożi dijabetika, komplikazzjoni ta ’ dijabete mhux ikkontrollata Disturbi psikjatriċi:
Respiratory disorders:
161 Disturbi respiratorji:
Interstitial pneumonia (inflammation of the lungs including fatal outcome), blood clots in the lung Gastrointestinal disorders: stomach ulcer, inflammation of the pancreas Liver disorders:
Ulċera fl- istonku, infjammazzjoni tal- frixa Disturbi fil- fwied:
Inflammation of the muscles
Infjammazzjoni tal- muskoli Disturbi fil- kliewi:
159 Renal disorders: renal failure Injury or poisoning:
Insuffiċjenza tal- kliewi Korriment jew avvelenament:
Keep the pre-filled syringe in the outer carton in order to protect from light.
Żomm is- siringa mimlija għal- lest fil- kartuna ta ’ barra sabiex tilqa ’ mid- dawl
Do not use Pegasys if the syringe or needle packaging is damaged, if the solution is cloudy or if it has floating particles or if the medicine is any colour besides colourless to light yellow.
M’ għandekx tuża Pegasys jekk is- siringa jew il- pakkett tal- labra jkollhom xi ħsara, it- soluzzjoni ma tkunx ċara jew jekk hemm xi frak jew jekk il- mediċina tkun xi kulur ieħor ħlieftrasparenti għal isfar ċar.
with bis-[monomethoxy polyethylene glycol] of a molecular mass, Mn, of 40 000), 135 micrograms in a pre-filled syringe.
[monomethoxy polyethylene glycol] ta ’ massa molekulari, Mn, ta ’ 40, 000.), 135 mikrogramma f’ siringa mimlija għal- lest.
160 What Pegasys looks like and contents of the pack
Id- Dehra ta ’ Pegasys u l- kontenuti tal- pakkett
Pegasys is presented as a solution for injection in a pre-filled syringe (0.5 ml) with a separate injection needle available in packs containing 1, 4 or 12 pre-filled syringes.
Pegasys huwa ppreżentat bħala soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest (0. 5 ml) b’ labra għall- injezzjoni separata, disponnibli f’ pakketti li fihom 1, 4 jew 12- il siringa mimlija għal- lest.
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Għall kull tagħrif dwar din il- mediċina, ikkuntattja lir- rappreżentant lokali tad- Detentur ta ’ l - Awtorizzazzjoni għat- tqegħid fis- Suq:
Österreich Roche Austria GmbH Tel: +43 (0) 1 27739
163 Polska Ελλάδα Roche Polska Sp. z o. o.
HOW TO SELF- INJECT PEGASYS
KIF TINJETTA PEGASYS LILEK INNIFSEK
The following instructions explain how to use Pegasys pre-filled syringes to inject yourself.
L- istruzzjonijiet li ġejjin jispjegaw kif tuża s- siringa mimlija għal- lest b' Pegasys biex tinjetta lilek innifsek.
Getting ready
Preparamenti
Wash your hands carefully before handling any of the items.
Aħsel idejk sew qabel ma tmiss xi wieħed mill- oġġetti.
- a pre-filled syringe of Pegasys
- Siringa mimlija għal- lest b' Pegasys
- an injection needle
- Labra għall- injezzjoni
Not included in the pack:
Mhux inklużi fil- pakkett:
- a cleansing swab
- mselħa
- small bandage or sterile gauze
- biċċa faxxa żgħira jew garża sterili
- an adhesive bandage
- biċċa faxxa adeżiva
- a container for the waste material
- kontenitur għar- rimi ta ’ l- affarijiet użati
Preparing the syringe and needle for injection
Kif tipprepara s- siringa u l- labra għall- injezzjoni
● Remove the protective cap that covers the back of the needle (1-2).
Neħħi l- għatu protettiv li jgħatti n- naħa ta ’ wara tal- labra (1- 2). ●
162 ● Remove the rubber cap from the syringe (3).
Neħħi l- għatu tal- gomma minn mas- siringa (3).
Do not touch the tip of the syringe.
Tmisx il- ponta tas- siringa. ●
● Place the needle firmly on the tip of the syringe (4).
Waħħal sew il- labra mal- ponta tas- siringa (4). ●
● Remove the needle guard from the syringe needle (5).
Neħħi l- għatu tal- labra mill- labra tas- siringa (5). ●
● To remove air bubbles from the syringe, hold the syringe with the needle pointing up.
Biex tneħħi l- bżieżaq ta ’ l- arja minn ġos- siringa, żomm is- siringa bil- labra tipponta ‘ l fuq.
Tap the syringe gently to bring the bubbles to the top.
Tektek ● is- siringa bil- mod sabiex il- bżieżaq jitilgħu fil- parti ta ’ fuq.
Push the plunger up slowly to the correct dose.
Imbotta bil- mod il- planġer sad- doża t- tajba.
Change your injection site each time. ● Clean and disinfect the skin where the injection is to be made with a cleansing swab. ● Wait for the area to dry. ● Remove the needle guard. ● With one hand, pinch a fold of loose skin.
Naddaf u ddiżinfetta b’ imselħa li tnaddaf l- ġilda fejn tkun ser tinjetta. ● Stenna l- post jinxef. ● Neħħi l- għatu tal- labra. ● B’ id waħda, oqros ftit mill- ġilda biex tifforma tinja.
163 ● Inject the solution by gently pushing the plunger all the way down. ● Pull the needle straight out of the skin. ● Press the injection site with a small bandage or sterile gauze if necessary for several seconds.
165 Injetta t- soluzzjoni billi timbotta bil- mod il- planġer s’ isfel nett. ● Iġbed il- labra ’ l barra mill- ġilda. ● Jekk hemm bżonn għafas għal ftit sekondi l- post fejn tajt l- injezzjoni b’ biċċa faxxa żgħira jew ● b’ garża sterili.
The syringe, needle and all injection materials are intended for single use and must be discarded after the injection.
Is- siringa, il- labra u l- materjali kollha ta ’ l- injezzjoni huma maħsuba għall- użu ta ’ darba biss u għandhom jintremew wara l- injezzjoni.
164 PACKAGE LEAFLET:
166 FULJETT TA ’ TAGĦRIF:
Pegasys 180 micrograms solution for injection in pre-filled syringe Peginterferon alfa-2a
Pegasys 180 mikrogramma soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest Peginterferon alfa- 2a
Pegasys is used for the treatment of chronic hepatitis B or C, which are viral infections of the liver.
Pegasys jintuża fil- kura ta ’ epatite B jew Ċ kronika, li huma infezzjonijiet virali tal- fwied.
- if you have a problem with your liver other than hepatitis B or C.
- jekk tbati minn xi marda oħra tal- fwied minbarra l- epatite B jew Ċ.
166 Breast-feeding:
Treddigħ:
In combination therapy with ribavirin, take notice of the respective informing texts of ribavirin containing medicinal products.
168 F’ terapija kombinata ma ’ ribavirin, ara l- fuljetti ta ’ tagħrif rispettivi tal- prodotti mediċinali li fihom ribavirin.
The duration of combination treatment varies from 4 to 18 months depending on the type of virus you are infected with, on treatment response and whether you have been treated before.
It- tul tal- kura kombinata tvarja minn 4 sa 18 il- xahar skond it- tip ta ’ virus li tkun infettat bih, ir - rispons għall- kura u jekk kontx ikkurat/ a minn qabel.
If you realise you missed your injection 6 days after it was scheduled, you should wait and take your dose on the next day, your regularly scheduled day.
169 Jekk tinduna li nsejt tieħu l- injezzjoni tiegħek sitt ijiem wara li suppost, għandek tistenna u tieħu d- doża l- ġurnata ta ’ wara, il- ġurnata tas- soltu.
Upper respiratory infection, bronchitis, fungal infection of the mouth and herpes (a common recurring viral infection affecting the lips, mouth) Blood disorders:
Infezzjonijiet ikkawżati mill- moffa, virali u mill- batterja. Infezzjoni fl- apparat respiratorju ta ’ fuq, bronkite, infezzjoni tal- fungu fil- ħalq u herpes (infezzjoni virali rikorrenti, li sseħħ b’ mod komuni li taffettwa x- xofftejn, ħalq) Disturbi fid- demm:
168 Ear disorders:
Disturbi fil- widnejn:
Bleeding in the retina (back of the eye) Ear disroders:
Fsada fir- retina (il- parti ta ’ wara ta ’ l- għajn) Disturbi fil- widnejn:
Severe allergis reaction, systemic lupus erythematosus (an illness where the body attacks its own cells), rheumatoid arthritis (an autoimmune disease) Endocrine disorders:
Reazzjoni allerġika severa, lupus eritematosus sistemika (marda fejn il - ġisem jattakka iċ- ċelluli tiegħu stess), artrite rewmatojda (marda awtoimmuni) Disturbi endokrinarji:
Respiratory disorders:
171 Disturbi respiratorji:
169 Renal disorders: renal failure Injury or poisoning:
Insuffiċjenza tal- kliewi Korriment jew avvelenament:
Do not use Pegasys if the syringe or needle packaging is damaged, if the solution is cloudy or if it has floating particles or if the medicine is any colour besides colourless to light yellow.
M’ għandekx tuża Pegasys jekk is- siringa jew il- pakkett tal- labra jkollhom xi ħsara, it- soluzzjoni ma tkunx ċara jew jekk hemm xi frak jew jekk il- mediċina tkun xi kulur ieħor ħlief trasparenti għal isfar ċar.
with bis-[monomethoxy polyethylene glycol] of a molecular mass, Mn, of 40 000), 180 micrograms in a pre-filled syringe.
[monomethoxy polyethylene glycol] ta ’ massa molekulari, Mn, ta ’ 40, 000.), 180 mikrogramma f’ siringa mimlija għal- lest.
170 What Pegasys looks like and contents of the pack
Id- Dehra ta ’ Pegasys u l- kontenuti tal- pakkett
- a cleansing swab
- mselħa biex tnaddaf
172 ● Remove the rubber cap from the syringe (3).
Neħħi l- għatu tal- gomma minn mas- siringa (3).
Push the plunger up slowly to the correct dose.
Imbotta il- planġer ’ l fuq bil- mod sad - doża t- tajba.
173 ● Inject the solution by gently pushing the plunger all the way down. ● Pull the needle straight out of the skin. ● Press the injection site with a small bandage or sterile gauze if necessary for several seconds.
175 Injetta t- soluzzjoni billi timbotta bil- mod il- planġer s’ isfel nett. ● Iġbed il- labra ’ l barra mill- ġilda. ● Jekk hemm bżonn għafas għal ftit sekondi l- post fejn tajt l- injezzjoni bi biċċa faxxa żgħira jew ● b’ garża sterili.
If there is bleeding, cover with an adhesive bandage.
Jekk joħroġ xi demm, għatti bi biċċa faxxa adeżiva.
Ask your doctor, hospital or pharmacist for an appropriate container.
Staqsi lit- tabib, sptar jew lill- spiżjar tiegħek għal kontenitur approprjat.
What is PegIntron?
X’ inhu PegIntron?
PegIntron is a medicine containing the active substance peginterferon alfa-2b.
PegIntron hu mediċina li fiha s- sustanza attiva peginterferon alfa- 2b.
It is available as a powder and solvent to be made up into a solution for injection, and as a single use pre-filled pen.
Tiġi bħala trab u solvent biex titħallat f’ soluzzjoni għall- injezzjoni, u bħala pinna mimlija għal- lest biex tintuża darba biss.
These all contain 50, 80, 100, 120, or 150 micrograms of peginterferon alfa-2b per 0.5 ml.
Dawn kollha fihom 50, 80, 100, 120, jew 150 mikrogramma peginterferon alfa- 2b kull 0. 5 ml.
What is PegIntron used for?
Għal x’ hiex jintuża PegIntron?
PegIntron is used to treat adult patients with chronic (long-term) hepatitis C (a disease of the liver due to infection with the hepatitis C virus).
PegIntron jintuża fit- trattament ta ’ pazjenti adulti bl- epatite Ċ kronika (fuq tul ta ’ żmien) (marda tal - fwied ikkawżata minn infezzjoni bil- vajrus ta ’ l- epatite Ċ.
PegIntron is used in patients whose liver is still functioning but who have signs of the disease (raised transaminases [liver enzymes] and markers of infection in the blood, such as viral RNA or antibodies against the virus).
PegIntron jintuża f’ pazjenti li l- fwied tagħhom ikun għadu jiffunzjona iżda li jkollhom sinjali tal- marda (żieda fit- transaminases [enzimi tal - fwied] u fil- markaturi ta ’ l- infezzjoni fid- demm, bħal RNA virali jew antikorpi kontra l- virus).
It can be used in patients also infected with human immunodeficiency virus (HIV).
Jista ’ jintuża f’ pazjenti li jkunu wkoll infettati bil- vajrus uman ta ’ l- immunodefiċjenza (HIV).
The best way to use PegIntron is with ribavirin (an antiviral medicine).
L- aqwa mod li jintuża PegIntron huwa ma ’ ribavirin (mediċina antivirali).
This combination is suitable for treatment-naïve patients (who have not been treated before) and for patients in whom previous treatment including any type of interferon alfa, with or without ribavirin, did not work.
Din il- kumbinazzjoni hi tajba għal pazjenti li ma jkunux irċevew trattament qabel u għal pazjenti li ma jkun ħadem fihom l- ebda trattament ieħor, inkluż kull tip ta ’ interferon alfa bi jew mingħajr ribavirin..
PegIntron can be used alone if the patient does not tolerate or should not take ribavirin.
PegIntron jista ’ jintuża waħdu jekk il- pazjent ma jkunx jittollera jew ma jkunx jista ’ jieħu ribavirin.
How is PegIntron used?
Kif jintuża PegIntron?
PegIntron treatment should be initiated and supervised by a doctor who has experience in the management of patients with hepatitis C.
It- trattament b’ PegIntron għandu jinbeda u jiġi sorveljat minn tabib li jkollu esperjenza fil- ġestjoni ta ’ pazjenti bl- epatite Ċ.
PegIntron is given once a week as a subcutaneous injection (under the skin).
PegIntron jingħata darba f’ ġimgħa b’ injezzjoni taħt il- ġilda (subcutaneous injection).
It used on its own at a dose of 0.5 or 1 microgram per kilogram body weight per week, or at a dose of 1.5 micrograms/ kg/ week when used with ribavirin.
Jintuża waħdu f’ doża ta ’ 0. 5 mikrogrammi jew mikrogramma waħda għal kull kilogramma li jiżen il- pazjent kull ġimgħa, jew f’ doża ta ’ 1. 5 mikrogrammi għal kull kilogramma li jiżen il- pazjent kull ġimgħa meta jintuża ma ’ ribavirin.
The duration of treatment depends on the patient’ s condition and response to treatment, and ranges from 24 weeks to a year.
It- tul tat- trattament jiddependi mill- kundizzjoni tal- pazjent u r - rispons għat- trattament u jvarja minn 24 ġimgħa sa sena.
The dose may need to be adjusted for patients who experience side effects.
Jista ’ jkun hemm bżonn li d- doża tiġi aġġustata għal pazjenti li jesperjenzaw effetti sekondarji.
For full dosing information, see the Summary of Product Characteristics (also part of the EPAR).
Għat- tagħrif sħiħ dwar id- dożi, ara s - Sommarju tal- Karatteristiċi tal- Prodott (ukoll parti mill- EPAR).
PegIntron has to be stored in a refrigerator (2°C - 8°C).
PegIntron irid jinħażen fi friġġ (2°C - 8°C).
How does PegIntron work?
Kif jaħdem PegIntron?
The active substance in PegIntron, peginterferon alfa-2b, belongs to the group ‘ interferons’.
Is- sustanza attiva f’ PegIntron, peginterferon alfa- 2b, tagħmel parti mill- grupp magħruf bħala ‘ interferons ’.
Interferons are natural substances produced by the body to help it fight against attacks such as infections caused by viruses.
Interferons huma sustanzi naturali prodotti mill- ġisem biex jgħinuh jikkumbatti attakki bħal infezzjonijiet ikkawżati minn vajrusis.
7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Mhux magħruf kompletament kif l- interferons jaħdmu fil - mardiet ikkawżati mill- vajrusis, iżda hu maħsub li dawn jagħmluha ta ’ immunomodulaturi (sustanzi li 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged immune system, the body’ s defence system, works).
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged jimmodifikaw il- mod kif taħdem is- sistema immunitarja, li hi s- sistema ta ’ difiża tal- ġisem).
Alpha interferons may also block the multiplication of viruses.
L - interferoni alfa jistgħu wkoll jimblukkaw it- tkattir tal- vajrusis.
Peginterferon alfa-2b is similar to interferon alfa-2b, which is already available in the European Union (EU) as IntronA.
Peginterferon alfa- 2b jixbah lill- interferon alfa- 2b, li diġà jinstab fl- Unjoni Ewropea (UE) bħala IntronA.
In PegIntron, the interferon alfa-2b has been ‘ pegylated’ (coated with a chemical called polyethylene glycol).
F’ PegIntron, l- interferon alfa- 2b ġie ‘ pegylated ’ (miksi b’ kimika magħrufa polyethylene glycol).
This decreases the rate at which the substance is removed from the body and allows the medicine to be given less often.
Dan inaqqas ir- rata li biha s- sustanza titneħħa mill- ġisem u jippermetti li l- mediċina tingħata inqas spiss.
The interferon alfa-2b in PegIntron is produced by a method known as ‘ recombinant DNA technology’: the interferon alfa-2b is made by a bacterium that has received a gene (DNA), which makes it able to produce it.
L- interferon alfa- 2b f’ PegIntron hu prodott b’ metodu magħruf bħala ‘ teknoloġija rikombinanti tad- DNA ’: l- interferon alfa- 2b isir minn batterju li jkun irċieva ġene (DNA), li jagħmlu kapaċi jipproduċih.
The replacement acts in same way as naturally produced interferon alpha.
Is- sostituzzjoni taħdem bl- istess mod bħal interferon alpha prodott b’ mod naturali.
How has PegIntron been studied?
Kif ġie studjat PegIntron?
The use of PegIntron alone in chronic hepatitis C has been studied in one study in 1,224 treatment- naïve adult patients.
L- użu ta ’ PegIntron waħdu fl- epatite Ċ kronika ġie studjat fi studju wieħed li fih ħadu sehem 1, 224 pazjent adult li ma kinux ingħataw trattament qabel.
PegIntron used once a week for 48 weeks (at 0.5, 1 or 1.5 micrograms/ kg) was compared with interferon alfa-2b used at 3 million international units (IU) three times a week.
PegIntron użat darba f’ ġimgħa għal 48 ġimgħa (b’ 0. 5, 1 jew 1. 5 mikrogrammi għal kull kilogramma tqabbel ma ’ interferon alfa- 2b użat b’ doża ta ’ 3 miljun unità internazzjonali (IU) tliet darbiet fil- ġimgħa.
The use of PegIntron with ribavirin has been studied over 48 weeks in 1,580 treatment-naïve patients.
L- użu ta ’ PegIntron ma ’ ribavirin ġie studjat fuq perjodu ta ’ 48 ġimgħa f’ 1, 580 pazjent li ma kinux irċevew trattament qabel.
This study compared two schedules of PegIntron used with ribavirin with the combination of interferon alfa-2b and ribavirin.
Dan l- istudju qabbel żewġ skedi ta ’ PegIntron użati ma ’ ribavirin mal- kombinazzjoni ta ’ interferon alfa- 2b u ribavirin.
An additional two studies have looked at the use of PegIntron in combination with ribavirin in 565 patients also infected with HIV, and a further study looked at the use of this combination in 1,354 patients whose previous treatment including interferon alfa (pegylated or non-pegylated) did not work or whose disease had come back after previous treatment.
Studju ieħor ħares lejn l- użu ta ’ din il- kumbinazzjoni f’ 1, 354 pazjent li fit- trattament ta ’ qabel kienu qed jieħdu interferon alfa (pegylated jew mhux pegylated) u li ma kienx ħadmilhom jew li reġgħet ħarġitilhom il- marda wara trattament li kienu ħadu..
The main measure of effectiveness was the level of hepatitis C virus RNA circulating in the blood before and during treatment, and at ‘ follow-up’, 24 weeks later.
Il- mezz ewlieni tal- kejl ta ’ l- effikaċja kien il- livell ta ’ l- RNA tal- vajrus ta ’ l- epatite Ċ jiċċirkula fid - demm qabel u waqt it- trattament, u waqt il- vista segwenti, 24 ġimgħa wara.
What benefit has PegIntron shown during the studies?
X’ inhu l- benefiċċju ta ’ PegIntron li ntwera f’ dawn l- istudji?
In the first study, PegIntron was more effective than interferon alfa-2b.
Fl- ewwel studju, PegIntron kien iktar effettiv minn interferon alfa- 2b.
More patients had no circulating viral RNA after 24 weeks of treatment with PegIntron than with interferon alfa-2b:
Kien hemm iktar pazjenti mingħajr RNA virali wara 24 ġimgħa ta ’ trattament b’ PegIntron meta imqabbla ma ’ dawk b’ interferon alfa- 2b:
46% with PegIntron 1.5 microgram/ kg/ week compared with 24% with the comparator.
46% ma ’ PegIntron 1. 5 mikrogrammi għal kull kilogramma li jiżen il- pazjent kull ġimgħa imqabbla ma ’ 24% tal- mediċina tat- tqabbil.
Combining ribavirin and PegIntron (as a once-weekly injection of 1.5 micrograms/ kg) was more effective than the combination with interferon alfa-2b (3 million IU three times a week): more patients had responded to treatment at the end of the study (65% compared with 54%).
Il- kombinazzjoni ta ’ ribavirin u PegIntron (mogħtija bħala injezzjoni darba f’ ġimgħa ta ’ 1. 5 mikrogrammi/ kg) kienet iktar effettiva mill- kombinazzjoni ma ’ interferon alfa- 2b (3 miljun IU tliet darbiet fil- ġimgħa): iktar pazjenti kienu rrispondew għat- trattament fi tmiem l- istudju (65% mqabbla ma ’ 54%).
In the study of patients whose previous treatment did not work, around a fifth of the patients responded to treatment with PegIntron and ribavirin.
Il- kombinazzjoni ta ’ PegIntron ma ’ ribavirin kienet iktar effettiva wkoll għat- trattament ta ’ l- epatite Ċ f’ pazjenti infettati wkoll bl- HIV. Fl- istudju tal- pazjenti li ma kienx] admilhom it- trattament preċedenti, madwar wieħed minn kull ħamsa minnhom irrispondew għat- trattament b’ PegIntron u ribavarin
What is the risk associated with PegIntron?
X’ inhu r- riskju assoċjat ma ’ PegIntron?
For the full list of all side effects reported with PegIntron, see the Package Leaflet.
L- iktar effetti sekondarji komuni ma ’ PegIntron (li dehru f’ iktar minn pazjent wieħed minn kull 10) huma infezzjoni virali, t- telf tal- piż, depressjoni, irritabilità, insomnja (diffikultà fl- irqad), ansjetà, diffikultà fil- konċentrazzjoni, tibdil fil- burdata, uġigħ ta ’ ras, ħalq niexef, diffikultà fit- teħid tan- nifs, farinġite (uġigħ fil- griżmejn), sogħla, rimettar, dardir, uġigħ addominali, dijarea, anoressija (nuqqas ta ’ aptit), telf ta ’ xagħar, pruritus () akk), ġilda niexfa, raxx, uġigħ fil- muskoli, uġigħ fil- ġogi, uġigħ fil - muskoli u fil- għadam, infjammazzjoni fil- post ta ’ l- injezzjoni, uġigħ/ ħmurija fil- post ta ’ l- injezzjoni, sturdament, għejja, tkexkix tal- bard, deni, sintomi bħal ta ’ l- influwenza u astenja (djgħufija). Għal - lista sħiħa ta ’ l- effetti sekondarji kollha, ara l- Fuljett ta ’ Tagħrif.
PegIntron should not be used in people who may be hypersensitive (allergic) to any interferon or any of the other ingredients.
PegIntron m’ għandux jintuża minn persuni allerġiċi għal xi interferon jew għal xi sustanza oħra tiegħu.
PegIntron should not be used in: • patients with a history of severe heart disease, • patients with severe medical conditions, • patients with an auto-immune disease (when the body attacks itself), • patients with severe liver problems, • patients with thyroid disease unless it is controlled, • patients with epilepsy or other central nervous system problems, • HIV-infected patients with signs of serious liver disease.
PegIntron m’ għandux jintuża fuq: • pazjenti bi storja ta ’ mard tal- qalb sever, • pazjenti bi problemi mediċi severi, • pazjenti b’ mard awto- immunitarju (meta l- ġisem jattakka lilu nnifsu), • pazjenti bi problemi severi tal- fwied, • pazjenti b’ mard tat- tirojde sakemm dan ma jkunx ikkontrollat, • pazjenti bl- epilessija jew problemi oħra tas- sistema nervuża ċentrali, • pazjenti infettati bl- HIV b’ sinjali ta ’ mard serju fil- fwied.
In combination with ribavirin, PegIntron should not be used in patients with kidney problems.
PegIntron f’ kombinazzjoni ma ’ ribavirin, m’ għandux jintuża f’ pazjenti bi problemi tal- kliewi.
For a list of all restrictions with PegIntron, see the Package Leaflet.
Għal- lista sħiħa tar- restrizzjonijiet kollha għal PegIntron, ara l- Fuljett ta ’ Tagħrif.
Why has PegIntron been approved?
Għaliex ġie approvat PegIntron?
greater than its risks for the treatment of adult patients with chronic hepatitis C who have elevated transaminases without liver decompensation and who are positive for serum hepatitis C virus (HCV) RNA or anti-HCV including naïve patients with clinically stable HIV co-infection.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li PegIntron għandu iktar benefiċċji milli riskji meta użat fit- trattament ta ’ pazjenti adulti bl- epatite Ċ kronika li jkollhom livelli għoljin ta ’ transaminases mingħajr dikumpensazzjoni tal- fwied u li jkunu pożittivi għall- RNA tal- vajrus ta ’ l- epatite Ċ fid- demm (HCV) jew għall- anti- HCV inkluż f’ pazjenti li ma jkunux ingħataw trattament qabel u li fl- istess ħin ikollhom infezzjoni klinikament stabbli ta ’ l- HIV.
The Committee recommended that PegIntron be given marketing authorisation.
Il- Kumitat irrakkomnanda li PegIntron jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about PegIntron:
Tagħrif ieħor dwar PegIntron:
The European Commission granted a marketing authorisation valid throughout the European Union for PegIntron to SP Europe on 25 May 2000.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida fl- Unjoni Ewropea kollha għal PegIntron lil SP Europe fil- 25 ta ’ Mejju 2000.
The marketing authorisation was renewed on 25 May 2005.
L- awtorizzazzjoni għat- tqegħid fis- suq iġġeddet fil- 25 ta ’ Mejju 2005.
The full EPAR for PegIntron is available here.
L- EPAR sħiħ għal PegIntron jinstab hawn.
PegIntron 50 micrograms powder and solvent for solution for injection
PegIntron 50 mikrogrammi trab u solvent għal soluzzjoni għall- injezzjoni.
Each vial of PegIntron, powder for solution for injection contains 50 micrograms of peginterferon alfa-2b as measured on a protein basis.
Kull kunjett ta ’ PegIntron, trab għal soluzzjoni għall- injezzjoni fih 50 mikrogrammi ta ’ peginterferon alfa- 2b hekk kif imkejjel fuq bażi ta ’ proteina.
Each vial provides 50 micrograms/ 0.5 ml of peginterferon alfa-2b when reconstituted as recommended.
Kull kunjett jipprovdi 50 mikrogrammi/ 0. 5 ml ta ’ peginterferon alfa- 2b meta rikostitwit kif rakkomandat.
The active substance is a covalent conjugate of recombinant interferon alfa-2b* with monomethoxy polyethylene glycol.
Is- sustanza attiva hija konjugat ta ’ interferon alfa- 2b * rikombinat b’ monomethoxy polyethylene glycol.
The potency of this product should not be compared to that of another pegylated or non-pegylated protein of the same therapeutic class.
Il - qawwa ta ’ dan il- prodott m’ għandux jitqabbel ma ’ proteina oħra pegilata jew mhux pegilata ta ’ l- istess klassi terapewtika.
For more information, see section 5.1. *produced by rDNA technology in E. coli cells harbouring a genetically engineered plasmid hybrid encompassing an interferon alfa-2b gene from human leukocytes
Għal aktar informazzjoni, ara sezzjoni 5. 1. * magħmul bit- teknoloġija ta ’ rDNA f’ ċelluli E. coli bl- istess plasmid ibrida li jkun fiha ġene ta ’ interferon alfa- 2b minn ċelluli ta ’ lewkoċiti umani.
PegIntron contains 40 mg of sucrose per 0.5 ml.
PegIntron fih 40 mg sucrose għal kull 0. 5 ml.
Powder and solvent for solution for injection White powder.
Trab u solvent għal soluzzjoni għall- injezzjoni Trab abjad.
PegIntron is indicated for the treatment of adult patients with chronic hepatitis C who have elevated transaminases without liver decompensation and who are positive for serum HCV-RNA or anti-HCV, including naïve patients with clinically stable HIV co-infection (see section 4.4).
PegIntron jintuża għat- trattament ta ’ pazjenti adulti b’ epatite Ċ kronika li għandhom transaminases għoljin mingħajr nuqqas ta ’ kumpensament tal- fwied u li huma pożittivi għal HCV- RNA fis- serum jew anti- HCV inklużi pazjenti naïve pazjenti b’ ko- infezzjoni ta ’ HIV klinikament stabbli (ara sezzjoni 4. 4).
The best way to use PegIntron in this indication is in combination with ribavirin.
L- aħjar mod biex tuża PegIntron f’ din l- indikazzjoni huwa f’ kombinazzjoni ma 'ribavirin.
This combination is indicated in naïve patients including patients with clinically stable HIV co- infection and in patients who have failed previous treatment with interferon alpha (pegylated or nonpegylated) and ribavirin combination therapy or interferon alpha monotherapy (see section 5.1).
Din il- kombinazzjoni tintuża f’ pazjenti naïve inklużi pazjenti b’ ko- infezzjoni ta ’ HIV klinikament stabbli u f’ pazjenti li fallew għall- kura li tkun ingħatat qabel b’ interferon alpha (pegilata jew mhux pegilata) u terapija kombinata b’ ribavirin jew monoterapija b’ interferon alpha (ara sezzjoni 5. 1).
Interferon monotherapy, including PegIntron, is indicated mainly in case of intolerance or contraindication to ribavirin.
Il- monoterapija b’ interferon, li tinkludi PegIntron, tintuża l- aktar f’ każ ta ’ intolleranza jew f’ każ li ribavirin ikun kontra- indikat.
Please refer also to the ribavirin Summary of Product Characteristics (SPC) when PegIntron is to be used in combination with ribavirin.
Jekk jogħġbok irreferi wkoll għas- Sommarju tal- Karatteristiċi tal- Prodott (SPC) ta ’ ribavirin meta PegIntron ikun ser jintuża flimkien ma 'ribavirin.
Treatment should be initiated and monitored only by a physician experienced in the management of patients with hepatitis C.
It- trattament għandu jinbeda u jsir biss taħt is- sorveljanza ta ’ tabib b’ esperjenza fl- imanniġjar ta ’ pazjenti b’ epatite Ċ.
Dose to be administered PegIntron should be administered as a once weekly subcutaneous injection.
Id- doża li għandha tingħata PegIntron għandu jkun amministrat bħala injezzjoni taħt il- ġilda darba f’ ġimgħa.
The dose administered depends on whether it is used in combination with ribavirin or as monotherapy.
Id- doża amministrata tiddependi fuq jekk hijiex użata flimkien ma 'ribavirin jew bħala monoterapija.
2 Combination therapy PegIntron 1.5 micrograms/ kg/ week in combination with ribavirin capsules.
Terapija konġunta PegIntron 1. 5 mikrogrammi/ kg/ ġimgħa flimkien ma 'kapsuli ta ’ ribavirin.
The intended dose of 1.5 μ g/ kg of PegIntron to be used in combination with ribavirin may be delivered in weight categories with the pen/ vial strengths according to Table 1.
Id- doża maħsuba ta ’ 1. 5 μg/ kg ta ’ PegIntron li għandha tintuża flimkien ma 'ribavirin tista ’ tingħata f’ kategoriji ta ’ piż bil- qawwiet tal- pinna/ kunjett skond Tabella 1.
Ribavirin capsules are to be administered orally each day in two divided doses with food (morning and evening).
Il- kapsuli ta ’ ribavirin għandhom ikunu mogħtija mill- ħalq kuljum f’ żewġ dożi maqsumin ma ’ l- ikel (filgħodu u filgħaxija).
Table 1 - Dosing for Combination Therapy
Tabella 1 – Doża għal Terapija Konġunta
Body Weight (kg)
Piż tal- Ġisem (kg)
Ribavirin Capsules
Kapsuli ta ’ Ribavirin
Vial/ Pen Strength
Doża Totali ta ’
Administer
Numru ta ’
Total Daily
Pinna/ Kunjett
Number of
Darba fil -
(μ g/ 0.5ml)
Kuljum (mg)
Once Weekly (ml)
(μg/ 0. 5ml)
Dose (mg)
Ġimgħa (ml)
2 morning, 2 evening b:
2 filgħodu, 2 filgħaxija b:
2 morning, 3 evening c:
2 filgħodu, 3 filgħaxija ċ:
3 morning, 3 evening d:
3 filgħodu, 3 filgħaxija d:
3 morning, 4 evening
3 filgħodu, 4 filgħaxija
0.5 0.5 0.5 0.5
0. 5
5b 5b 6c 7d
1, 400
Duration of treatment – Naïve patients Predictability of sustained virological response:
Tul tat- trattament għal pazjenti li qatt ma kienu ħadu din il- kura qabel Tbassir tar- reazzjoni viroloġika miżmuma:
Patients infected with virus genotype 1 who fail to achieve virological response at Week 12 are highly unlikely to become sustained virological responders (see also section 5.1). • Genotype 1:
Pazjenti infettati b’ vajrus tal- ġenotip 1 li jonqsu milli jiksbu reazzjoni viroloġika wara 12- il ġimgħa x' aktarx li ma jirrispondux b' mod viroloġiku sostnut (ara ukoll sezzjoni 5. 1). • Ġenotip 1:
For patients who exhibit virological response at week 12, treatment should be continued for another nine month period (i. e., a total of 48 weeks).
Għal pazjenti li juru reazzjoni viroloġika fil- ġimgħa 12, it- trattament għandu jitkompla għal perijodu ieħor ta ’ disa ’ xhur (i. e., total ta ’ 48 ġimgħa).
In the subset of patients with genotype 1 infection and low viral load (< 600,000 IU/ ml) who become HCV-RNA negative at treatment week 4 and remain HCV-RNA negative at week 24, the treatment could either be stopped after this 24 week treatment course or pursued for an additional 24 weeks (i. e. overall 48 weeks treatment duration).
Fis- sottogrupp ta ’ pazjenti b’ infezzjoni tal- ġenotip 1 u viral load baxx (< 6000, 000 IU/ ml) li jsiru negattivi għal HCV- RNA mar- 4 ġimgħa ta ’ kura u jibqgħu negattivi għal HCV- RNA ma ’ l - 24 ġimgħa ta ’ kura, il- kura tista ’ titwaqqaf wara dan il- kors ta ’ 24 ġimgħa jew jitkompla għal 24 ġimgħa oħra (i. e. b’ kollox 48 ġimgħa ta ’ kura).
However, an overall 24 weeks treatment duration may be associated with a higher risk of relapse than a 48 weeks treatment duration (see section 5.1). • Genotypes 2 or 3:
Madankollu, tul ta ’ kura li jdum 24 ġimgħa b’ kollox jista ’ jkun assoċjat ma ’ riskju akbar li jirkadu mill b’ kura li ddum 48 ġimgħa (ara sezzjoni 5. 1). • Ġenotipi 2 jew 3:
It is recommended that all patients be treated for 24 weeks, except for HCV/ HIV co-infected patients who should receive 48 weeks of treatment. • Genotype 4:
Huwa rakkomandat illi l- pazjenti jiġu ttrattati għal mill- inqas 24 ġimgħa, ħlief għall- pazjenti li jkollhom infezzjoni fl- istess ħin b’ HCV/ HIV li għandhom jirċievu kura ta ’ 48 ġimgħa. • Ġenotip 4:
In general, patients infected with genotype 4 are considered harder to treat and limited study data (n=66) indicate they are compatible with a duration of treatment as for genotype 1.
B’ mod ġenerali, pazjenti infettati b’ ġenotip 4 jitqiesu aktar diffiċli biex tikkurhom u dejta minn studji limitati (n=66) jindikaw li huma kompatibbli ma ’ tul ta ’ kura bħal dak ta ’ ġenotip 1.