qanastek/EMEA-V3 huggingface dataset:
ViraferonPeg 100 micrograms powder and solvent for solution for injection peginterferon alfa-2b (conjugation of recombinant interferon alfa-2b with monomethoxy polyethylene glycol)
ViraferonPeg 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 ViraferonPeg
Oqgħod attent ħafna b 'ViraferonPeg
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.
Always use ViraferonPeg exactly as your doctor told you.
Dejjem għandek tuża ViraferonPeg skond il- parir tat- tabib.
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’ ViraferonPeg: 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 VIRAFERONPEG
KIF TAĦŻEN X Żomm fejn ma jintlaħaqx u ma jidhirx mit- tfal.
293 The white powder is contained in a 2 ml glass vial and the clear and colourless solvent is presented in a 2 ml glass ampoule.
It- trab abjad qiegħed f’ kunjett tal- ħġieġ ta ’ 2 ml u s- solvent ċar u mingħajr kulur qiegħed f’ ampulla tal - ħġieġ ta ’ 2 ml.
ViraferonPeg 100 micrograms is available in different pack sizes:
ViraferonPeg 100 mikrogrammi huwa disponibbli f’ pakketti ta ’ daqsijiet differenti:
295 HOW TO SELF-INJECT VIRAFERONPEG?
KIF TINJETTA VIRAFERONPEG FUQEK INNIFSEK?
ViraferonPeg 120 micrograms powder and solvent for solution for injection peginterferon alfa-2b (conjugation of recombinant interferon alfa-2b with monomethoxy polyethylene glycol)
ViraferonPeg 120 mikrogrammi trab u solvent għal soluzzjoni għall- injezzjoni peginterferon alfa- 2b (konjugazzjoni ta ’ interferon alfa- 2b rikombinat b’ monomethoxy polyethylene glycol)
298 Take special care with ViraferonPeg
Oqgħod attent ħafna b 'ViraferonPeg
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’ ViraferonPeg: 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).
303 The white powder is contained in a 2 ml glass vial and the clear and colourless solvent is presented in a 2 ml glass ampoule.
It- trab abjad qiegħed f’ kunjett tal- ħġieġ ta ’ 2 ml u s- solvent ċar u mingħajr kulur qiegħed f’ ampulla tal - ħġieġ ta ’ 2 ml.
ViraferonPeg 120 micrograms is available in different pack sizes:
ViraferonPeg 120 mikrogrammi huwa disponibbli f’ pakketti ta ’ daqsijiet differenti:
305 HOW TO SELF-INJECT VIRAFERONPEG?
KIF TINJETTA VIRAFERONPEG FUQEK INNIFSEK?
ViraferonPeg 150 micrograms powder and solvent for solution for injection peginterferon alfa-2b (conjugation of recombinant interferon alfa-2b with monomethoxy polyethylene glycol)
ViraferonPeg 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 ViraferonPeg
Oqgħod attent ħafna b 'ViraferonPeg
In addition, dry mouth could have a damaging effect on teeth and membranes of the mouth during long-term treatment with the combination of ViraferonPeg 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 ’ ViraferonPeg ma ’ ribavirin.
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’ ViraferonPeg: 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).
313 The white powder is contained in a 2 ml glass vial and the clear and colourless solvent is presented in a 2 ml glass ampoule.
It- trab abjad qiegħed f’ kunjett tal- ħġieġ ta ’ 2 ml u s- solvent ċar u mingħajr kulur qiegħed f’ ampulla tal - ħġieġ ta ’ 2 ml.
ViraferonPeg 150 micrograms is available in different pack sizes:
ViraferonPeg 150 mikrogrammi huwa disponibbli f’ pakketti ta ’ daqsijiet differenti:
315 HOW TO SELF-INJECT VIRAFERONPEG?
KIF TINJETTA VIRAFERONPEG FUQEK INNIFSEK?
ViraferonPeg 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)
ViraferonPeg 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)
318 Take special care with ViraferonPeg
Oqgħod attent ħafna b 'ViraferonPeg
The refore, your blood will be checked regularly to be sure that the HIV infection is not getting worse.
Għalhekk, id- demm tiegħek ser jiġi eżaminat b’ mod regolari sabiex ikun aċċertat li l- marda ta ’ l- HIV ma tkunx qed tmur għall- agħar.
Detailed instructions for subcutaneous administration are provided with this leaflet (see How to use the ViraferonPeg pre-filled pen).
Istruzzjonijiet dettaljati għall - għotja minn taħt il- ġilda huma provduti ma ’ dan il- fuljett (ara Kif tinjetta ViraferonPeg fuqek innifsek fl - aħħar tal- fuljett ta ’ tagħrif).
ViraferonPeg is intended for single use only.
Armi kull soluzzjoni li tibqa fil- kunjett wara li tagħti l- injezzjoni lilek innifsek. / ViraferonPeg għandu jintuża darba biss.
Thus, after you give yourself the injection, discard the ViraferonPeg 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 ’ ViraferonPeg b’ kwalunkwe soluzzjoni li jista ’ jkun għad fiha.
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’ ViraferonPeg: 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 ViraferonPeg pre-filled pen and any unused solution contained in it.
Armi kwalunkwe materjal li jibqa.
How to use the ViraferonPeg pre-filled pen
Kif tuża l- pinna mimlija lesta ’ ta ’ ViraferonPeg
The following instructions explain how to inject yourself with the single use ViraferonPeg pre-filled pen.
L- istruzzjonijiet li ġejjin jispjegaw kif għandek tinjetta lilek innifsek bil- pinna mimlija lesta ta ’ ViraferonPeg 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 ViraferonPeg pre-filled pen.
It- tabib jew spiżjar tiegħek ser jurik kif tinjetta lilek innifsek bil- pinna mimlija lesta ta ’ ViraferonPeg.
The ViraferonPeg pre-filled pen should be used by one person only and must not be shared.
Il- pinna mimlija lesta ’ ta ’ ViraferonPeg 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 ViraferonPeg pre-filled pen.
Uża l- labra ta ’ l- injezzjoni u l- biċċiet għat- tindif provduti fil- pakkett biss għall- pinna mimlija għal - lest ta ’ ViraferonPeg.
The colour of the dosing button is different for each strength of the ViraferonPeg pre-filled pen.
Il- kulur tal- buttuna tad- dożaġġ hija differenti għal kull qawwa tal- pinna mimlija għal- lest ta ’ ViraferonPeg.
All of the supplies you will need are in the ViraferonPeg pack.
Il- pakkett fih:
The pack contains: • ViraferonPeg pre-filled pen • one disposable injection needle • two cleansing swabs, and • dosing tray b.
ViraferonPeg pinna mimlija għal- lest Labra waħ da għall- injezzjoni li tintuża darba u tintrema Żewġ biċċiet għat- tindif, u Trej għad- dożaġġi
The ViraferonPeg 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 ’ ViraferonPeg għandha tinħażen fil- friġġ, iżda oħroġha u ħalliha tilħaq it- temperatura tal- kamra qabel tużha.
Before taking the ViraferonPeg pre-filled pen out of its carton, check the expiration date printed on the carton.
Qabel toħroġ il- pinna mimlija għ al- lest ta ’ ViraferonPeg mill- kartuna tagħha, ikkontrolla d- data ta ’ skadenza ittimbrata fuq il- kartuna.
Do not use if the expiration date has passed. c Take the ViraferonPeg pre-filled pen out of the carton.
Oħroġ il- pinna mimlija għal- lest ta ’ ViraferonPeg mill- kartuna.
This is the ViraferonPeg which will be mixed with liquid inside the pen before it is injected. d.
Dan huwa il - ViraferonPeg li se jitħallat mal- likwidu fil- pinna qabel ma tiġi injettata. d.
Before you mix the ViraferonPeg, make sure it is at room temperature.
Qabel tħallat ViraferonPeg, aċċerta ruħek li laħqet it- temperatura tal- kamra.
It is important that you keep the ViraferonPeg pre-filled pen upright (Dosing button down) (as shown in figure 1).
Huwa importanti illi żżomm il- pinna mimlija għal- lest ta ’ ViraferonPeg wieqfa (Sinjal tad- dożaġġ iħares l- isfel) (kif jidher fi stampa 1).
Place the ViraferonPeg pre-filled pen upright in the holder of the tray provided in the pack (the dosing button will be on the bottom) on a hard, flat, non-slip surface.
Poġġi l- pinna mimlija għal- lesta ta ’ ViraferonPeg wieqfa fil - kontenitur tat- trej provdut fil- pakkett (il- buttuna tad- dożaġġ tkun mal- qiegħ) fuq superfiċje iebsa, ċatta, li ma tiżloqx.
To mix the powder and the liquid, keep the ViraferonPeg pre- filled pen upright in the dosing tray and press the top half of the pen downward toward the hard, flat, non-slip surface until you hear the pen click.
Biex tħallat it- trab u l- likwidu, żomm il- pinna mimlija għ al- lest ta ’ ViraferonPeg wieqfa fit- trej tad- dożaġġi u agħfas in- nofs ta ’ fuq tal- pinna ’ l isfel lejn is- superfiċje iebes, ċatt, li ma jiżloqx sakemm tisma l- pinna mimlija lesta tfaqqa.
DO NOT SHAKE THE PEN.
Il- buttuna tad- dożaġġi għandha tiġi flax mal- pinna. • Stenna għal diversi sekondi biex tħalli t- trab jinħall. • Aqleb bil- ħlewwa l- pinna mimlija lesta ta ’ ViraferonPeg ta ’ taħt fuq għal darbtejn.
Keep the ViraferonPeg pre-filled pen upright, with the dosing button down.
TĦAWWADX IL- PINNA. • Żomm il- pinna mnimlija għal- lesta ta ’ ViraferonPeg dritta ‘ l fuq,
The solution should be clear and colourless before use.
Ħowlder bil- buttuna tad- dożaġġ l- isfel.
Figure 1
Imbagħad ħares lejn s- soluzzjoni ta ’ Stampa 1 ViraferonPeg mit- twejqa biex tara li s- soluzzjoni ta ’ ViraferonPeg imħallta tkun inħallet għall- kollox.
contains particles.
Is- soluzzjoni għandha tkun ċara u mingħajr kulur.
Before attaching the needle, it is normal to see some small bubbles in the pre-filled pen window, near the top of the solution.
Tużax is - soluzzjoni tkun tilfet il- kulur, mhux ċara jew ikun fiha xi frak.
Place the pen back into the holder in the tray with the dosing button on the bottom.
Qabel twaħħal il- labra, hi ħaġa normali li tara bżieżaq żgħar fit - twejqa tal- pinna mimlija għal- lest, ħdejn il- parti ta ’ fuq tas - soluzzjoni.
Keeping the pen upright in the tray holder, wipe the rubber membrane of the ViraferonPeg pre-filled pen with one cleansing swab.
Waqt li żżomm il- pinna mimlija lesta ta ’ ViraferonPeg wieqfa fil- kontenitur provdut fil- pakkett, iddiżinfetta l- membrana tal - lastku tal- pinna mimlija lesta ta ’ ViraferonPeg b‘ biċċa għat - tindif.
Take the injection needle provided in the tray and remove its protective paper tab, but DO NOT remove either the outer cap or the yellow inner cap from the injection needle.
Waqt li żżomm il- pinna mimlija lesta ta ’ ViraferonPeg wieqfa fil- kontenitur, imbotta l- labra ta ’ l- injezzjoni bil - ħlewwa għal fuq il- pinna mimlija lesta u ssikkah sew ġo
Keeping the pen upright in the tray holder, FIRMLY push the injection needle straight onto the pen rubber membrane (figure 2) and screw it securely in place, in a clockwise direction.
Żomm il- pinna mimlija għal- lest ta ’ ViraferonPeg ‘ L FUQ (buttuna tad- dożaġġ l- isfel) u ħalli ż - żewġ tappijiet tal- labra fuqha sakemm tkun lest/ a għall- injezzjoni.
• Keep the ViraferonPeg pre-filled pen UPRIGHT (Dosing button down) and keep both needle caps on until you are ready to inject. • Screwing the needle into place, “primes” the needle and allows the extra liquid and air in the pen to be removed.
Meta tivvita l- labra f’ postha, il- labra tiġi “ prajmjata ” u tippermetti li dak il- likwidu żejjed li jkun hemm jitneħħa.
You will push it in when you are ready to self-inject the Dark ring
Ser timbuttaha ‘ l ġewwa meta tkun lest/ a biex tinjetta ViraferonPeg fuqek innifsek.
ViraferonPeg.
Ċirku skur
DO NOT remove either of the needle caps and DO NOT push the dosing button in until you are ready to self-inject the ViraferonPeg dose.
M’ GĦANDEKX tneħħi la l- għotjien tal- labra u M’ GĦANDEKX tagħfas il- buttuna tad- dożaġġ sakemm ma tkunx lest biex tinjetta lilek innifsek bid- doża ta ’ ViraferonPeg.
Inject the ViraferonPeg solution
Injetta s- soluzzjoni ta ’ ViraferonPeg
You should use a different site each time you inject ViraferonPeg to avoid soreness at any one site.
Għandek tuża post differenti kull darba li tinjetta ViraferonPeg sabiex tevita li tisloħ post wieħed.
Do not inject ViraferonPeg into an area where the skin is irritated, red, bruised, infected, or has scars, stretch marks, or lumps.
M’ għandekx tinjetta ViraferonPeg f’ parti fejn ikollok il- ġilda irritata, ħamra, imbenġla, infettata, jew ikollok xi ċikatriċi, marki tat- tqala, jew għoqod.
Hold the ViraferonPeg pre-filled pen with your fingers wrapped around the pen body barrel and your thumb on the dosing button (figure 7).
Żomm il- pinna mimlija għal- lest ta ’ ViraferonPeg bis - swaba ’ tiegħek madwar il- kanna tal- pinna u bis- saba ’ l - kbir fuq il- buttuna tad- dożaġġ (stampa 7).
If there is bleeding, cover with an adhesive bandage. • Discard the ViraferonPeg pre-filled pen with the needle safely in a closed rigid container.
Jekk hemm xi fsada, għatti b’ impjastru żgħ ir. • Armi l- pinna mimlija lesta ta ’ ViraferonPeg bil- labra b’ mod li ma tkunx ta ’ periklu ġo kontenitur magħluq u iebes.
ViraferonPeg 80 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)
ViraferonPeg 80 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)
ViraferonPeg, 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.
ViraferonPeg, 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.
331 Take special care with ViraferonPeg
Oqgħod attent ħafna b 'ViraferonPeg
- If you are di abetic, your doctor may ask you to have an eye examination.
- Jekk inti dijabetiku, it- tabib tiegħek jista ’ jitolbok tagħmel eżami tal- għajnejn.
Additionally, patients treated with ViraferonPeg and ribavirin combination therapy and zidovudine could be at increased r isk of developing anaemia (low number of red blood cells).
Minbarra hekk, pazjenti ikkurati b’ terapija kombinata ta ’ ViraferonPeg u ribavirin u zidovudine jista ’ jkollhom riskju akbar li jiżviluppaw anemija (numru baxx ta ’ ċelluli ħomor tad- demm).
Your doctor has prescribed ViraferonPeg specifically for you and your current condition; do not share th is medicine with anyone else.
It- tabib tiegħek kiteb ViraferonPeg speċifikament għalik u għall- kundizzjoni attwali tiegħek; m' għandekx taqsam din il- mediċina ma ’ ħaddieħor.
335 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’ ViraferonPeg: palsi tal- wiċċ (dgħjufija u naħa waħda tal- wiċċ jitgħawweġ) u reazzjonijiet allerġiċi severi bħal anġjoedema (marda allerġika tal- ġilda li l - karatteristika tagħha hija dbabar ta ’ nefħa ċirkomċiża li tinvolvi l- ġilda u s- saffi ta ’ taħtha, il- membrani mukużi, u kultant l- organi interni), nekroliżi tossika ta ’ l- epidermide/ Sindrome ta ’ Stevens Johnson/ erythema multiforme (medda ta ’ raxxijiet b’ gradi varji ta ’ severità inkluża l- mewt li tista ’ tkun assoċjata ma ’ bżieżaq fil- ħalq, imnieħer, għajnejn u membrani mukużi oħrajn u tinqala l- ġilda tal- parti affettwata), manija (entużjażnu eċċessiv jew bla- raġuni), disturbi bipolari (disturbi fil- burdati li l - karatteristika tagħhom hija episodji li jalternaw bejn dwejjaq u eċitament), effużjoni perikardijaka (jinġabar fluwidu bejn il perikardju (rita mad- dawra tal- qalb) u l- qalb innifisha), perikardite (infjammazzjoni tar- rita tal- qalb).
Additionally, Vogt -Koyanagi-Harada syndrome (an autoimmune inflammatory disorder affecting the eyes, skin and the membranes of the ears, brain and spinal cord) has been reported with ViraferonPeg use.
Minbarra hekk, bl- użu ta ’ ViraferonPeg kienet irrappurtata s- sindrome ta ’ Vogt- Koyanagi- Harada (marda awto- immunitarja infjammatorja li teffettwa l- għajnejn, il- ġilda u l- membrani tal- widnejn, moħħ u s- sinsla).
SP Europe, 73, rue de Stalle, B-11 80 Bruxelles, Belgium
SP Europe, 73, rue de Stalle, B- 1180 Bruxelles, Il - Belġju
This is the ViraferonPeg which will be mixed with liquid inside the pen before it is injected. d.
Dan huwa il - ViraferonPeg li se jitħallat mal- likwidu fil- pinna qabel ma tiġi injettata. h.
The dosing button should be
TĦAWWADX IL- PINNA. • Żomm il- pinna mnimlija għal- lesta ta ’ ViraferonPeg dritta ‘ l fuq,
button
Ħowlder bil- buttuna tad- dożaġġ l- isfel.
SHAKE THE PEN. • Keep the ViraferonPeg pre-filled pen upright, with the dosing button down.
Is- soluzzjoni għandha tkun ċara u mingħajr kulur.
Then, look through the pen window to see that the mixed ViraferonPeg solution is competely dissolved.
Tużax is - soluzzjoni tkun tilfet il- kulur, mhux ċara jew ikun fiha xi frak.
You will push it in when you are ready to self-inject the ViraferonPeg.
Ser timbuttaha ‘ l ġewwa meta tkun lest/ a biex tinjetta ViraferonPeg fuqek innifsek.
If there is bleeding, cover with an adhesive bandage. • Discard the ViraferonPeg pre -filled pen with the needle safely in a closed rigid container.
Jekk hemm xi fsada, għatti b’ impjastru żgħ ir. • Armi l- pinna mimlija lesta ta ’ ViraferonPeg bil- labra b’ mod li ma tkunx ta ’ periklu ġo kontenitur magħluq u iebes.
ViraferonPeg 100 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)
ViraferonPeg 100 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)
344 Take special care with ViraferonPeg
Oqgħod attent ħafna b 'ViraferonPeg
- If you develop symptoms associated w ith a cold or other respiratory infection, such as fever, cough,
- Jekk tiżviluppa sintomi assoċjati ma ’ riħ jew infezzjoni respiratorja oħra, bħal deni, sogħla, jew xi
348 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’ ViraferonPeg: 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).
This is the ViraferonPeg which will be mixed with liquid inside the pen before it is injected. d.
Dan huwa il - ViraferonPeg li se jitħallat mal- likwidu fil- pinna qabel ma tiġi injettata. l.
ViraferonPeg 120 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)
ViraferonPeg 120 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)
357 Take special care with ViraferonPeg
Oqgħod attent ħafna b 'ViraferonPeg
- If you have received an organ transplant, ei ther kidney or liver, interferon treatment may increase
- Jekk irċevejt trapjant ta ’ organu, jew kliewi jew fwied, kura b’ interferon tista ’ iżżid ir- riskju ta ’ riġett.
Thus, after you give yourself the injection, discard the ViraferonPeg 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 ’ ViraferonPeg b’ kwalunkwe soluzzjoni li jista ’ jkun għad fiha.
Additionally, the following events have been reported with ViraferonPeg: facial palsy (weakness and slumping on one side to the face) and severe allergic reactions such as angioedema (an allergic skin disease characterized by patches of circumscribed swelling involving the skin and its subcutaneous layers, the mucous membranes, and sometimes the internal organs), toxic epidermal
Minbarra hekk, il- każijiet li ġejjin kienu rrappurtati b’ ViraferonPeg: 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).
361 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, bl- użu ta ’ ViraferonPeg kienet irrappurtata s- sindrome ta ’ Vogt- Koyanagi- Harada (marda awto- immunitarja infjammatorja li teffettwa l- għajnejn, il- ġilda u l- membrani tal- widnejn, moħħ u s- sinsla).
This is the ViraferonPeg which will be mixed with liquid inside the pen before it is injected. d.
Dan huwa il - ViraferonPeg li se jitħallat mal- likwidu fil- pinna qabel ma tiġi injettata. p.
Keeping the pen upright in the tray holder, wipe the rubber membrane of the ViraferonPeg pre -filled pen with one cleansing swab.
Waqt li żżomm il- pinna mimlija lesta ta ’ ViraferonPeg wieqfa fil- kontenitur provdut fil- pakkett, iddiżinfetta l- membrana tal - lastku tal- pinna mimlija lesta ta ’ ViraferonPeg b‘ biċċa għat - tindif.
ViraferonPeg 150 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)
ViraferonPeg 150 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)
370 Take special care with ViraferonPeg
Oqgħod attent ħafna b 'ViraferonPeg
374 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, bl- użu ta ’ ViraferonPeg kienet irrappurtata s- sindrome ta ’ Vogt- Koyanagi- Harada (marda awto- immunitarja infjammatorja li teffettwa l- għajnejn, il- ġilda u l- membrani tal- widnejn, moħħ u s- sinsla).
This is the ViraferonPeg which will be mixed with liquid inside the pen before it is injected. d.
Dan huwa il - ViraferonPeg li se jitħallat mal- likwidu fil- pinna qabel ma tiġi injettata. t.
What is VIRAMUNE?
X' inhu VIRAMUNE?
VIRAMUNE is a medicine containing the active substance nevirapine.
VIRAMUNE huwa mediċina li fiha s- sustanza attiva nevirapine.
It is available as white, oval tablets (200 mg) and as an oral suspension (50 mg/ 5 ml).
Hija tiġi bħala pilloli ovali bojod (200 mg) u bħala sospensjoni orali (50 mg/ 5 ml).
What is VIRAMUNE used for?
Għalxiex jintuża VIRAMUNE?
VIRAMUNE is an antiviral medicine.
Viramune huwa mediċina antivirali.
It is used in combination with other antiviral medicines to treat patients infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Huwa jintuża flimkien ma 'mediċini antivirali oħra sabiex jittratta pazjenti infettati bil- virus ta' l- immunodefiċjenza umana ta 'tip 1 (HIV- 1), virus li jikkaġuna l- acquired immune deficiency syndrome (AIDS).
It is for use in patients who have immunodeficiency (problems with the immune system) that is advanced or getting worse.
Huwa jintuża f' pazjenti li għandhom immunodefiċjenza (problemi bis- sistema immunitarja) li hija avvanzata jew li sejra għall- agħar.
How is VIRAMUNE used?
Kif jintuża VIRAMUNE?
Treatment with VIRAMUNE should be given by a doctor who has experience in the treatment of HIV infection.
It- trattament b' VIRAMUNE għandu jingħata minn tabib li għandu esperjenza fit- trattament ta 'l - infezzjonijiet bl- HIV.
VIRAMUNE is never taken on its own.
VIRAMUNE qatt ma jittieħed waħdu.
It must be taken with at least two other antiviral medicines that the patient has not taken before.
Għandu jittieħed ma 'ta' lanqas żewġ mediċini antivirali oħra li l- pazjent ma jkunx ħa minnhom qabel.
Because the medicine can cause serious rash, treatment starts with 200 mg once a day for 14 days, before increasing the dose to the standard dose of one 200 mg tablet twice a day.
Peress li l- mediċina tista 'tikkaġuna raxx serju, it- trattament għandu jinbeda b' 200 mg darba kuljum għal 14- il jum, qabel ma d- doża tiżdied għad- doża standard ta' pillola ta '200 mg darbtejn kuljum.
The dose should not be increased to the full twice-daily dose until any rash has cleared.
Id- doża m' għandhiex tiżdied għal doża sħiħa ta 'darbtejn kuljum kemm- il darba r- raxx ikun għadu ma marx.
For patients under the age of 16 years who weigh less than 50 kg or whose body surface area (calculated using height and weight) is less than 1.25 m2, the dose depends on either the weight or the body surface area, and should be given using the oral suspension.
Għal pazjenti li huma taħt l - età ta '16- il sena li jiżnu inqas minn 50 kg jew li għandhom erja superfiċjali korporali (ikkalkulata permezz tat- tul u l- piż) ta' inqas minn 1. 25 m2, id- doża tiddependi jew fuq il- piż jew fuq l- erja superfiċjali korporali, u dawn il- pazjenti għandhom jingħataw is- sospensjoni orali.
How does VIRAMUNE work?
Kif jaħdem VIRAMUNE?
The active substance in VIRAMUNE, nevirapine, is a non-nucleoside reverse transcriptase inhibitor (NNRTI).
Is- sustanza attiva f' Viramune, nevirapine, hija impeditur non- nucleoside reverse transcriptase (NNRTI).
It blocks the activity of reverse transcriptase, an enzyme produced by HIV-1 that allows it to infect cells in the body and make more viruses.
Hija timblokka l- attività ta 'reverse transcriptase, enzima prodotta minn HIV- 1 li tippermettilha li tinfetta ċelloli fil- ġisem u tagħmel aktar virusijiet.
By blocking this enzyme, VIRAMUNE, taken in combination with other antiviral medicines, reduces the amount of HIV-1 in the blood and keeps it at a low level.
Meta jimblokka l- enzima, VIRAMUNE, li jittieħed flimkien ma 'mediċini antivirali oħra, inaqqas l- ammont ta' HIV- 1 fid- demm u jżommu f' livell baxx.
VIRAMUNE does not cure HIV-1 infection or AIDS, but it may delay the damage to the immune system and the development of infections and diseases associated with AIDS.
VIRAMUNE ma jikkurax l- infezzjoni ta 'HIV- 1 jew l- AIDS, imma jista' jdewwem il- ħsara għas- sistema immunitarja u l- iżvilupp ta 'infezzjonijiet u mard assoċjati ma' l- AIDS.
(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 antiviral medicines.
(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 Kif ġie studjat VIRAMUNE?
The effects of VIRAMUNE have also been studied in two studies including 478 children, taken alone or in combination with one or two other antiviral medicines.
L- effetti ta 'VIRAMUNE ġew studjati wkoll f' żewġ studji li kienu jinkludu 478 tifel u tifla, meħud waħdu jew f' kombinazzjoni ma' mediċina jew tnejn antivirali oħra.
The main measures of effectiveness were the change in the level of HIV in the blood (viral load) and in the number of CD4 T-cells in the blood (CD4 cell count), and the proportion of patients whose disease worsened or who died.
Il- miżuri ewlenin ta 'effikaċja kienu l- bidla fil- livell ta' HIV fid- demm (viral load) u l- għadd ta 'ċelloli- T CD4 fid- demm (għadd ta' ċelloli CD4), u l- proporzjon ta 'pazjenti li l- marda tagħhom marret għall- agħar jew mietu.
CD4 T-cells are white blood cells that are important in helping to fight infections but which are killed by HIV.
Iċ- ċelloli T CD4 huma ċelloli tad- demm bojod li huma importanti fil- ġlieda kontra l- infezzjonijiet, imma li huma maqtula bl- HIV.
What benefit has VIRAMUNE shown during the studies?
X' benefiċċji wera VIRAMUNE waqt dawn l- istudji?
VIRAMUNE, taken in combination with two other antiviral medicines, was more effective than combinations of two medicines.
VIRAMUNE, meta jittieħed flimkien ma 'żewġ mediċini antivirali oħra, kien aktar effettiv mill - kombinazzjonijiet ta' żewġ mediċini.
In 398 treatment-experienced adults (who had taken treatment for HIV infection before), VIRAMUNE, in combination with zidovudine and lamivudine, led to a 38% reduction in viral loads after 48 weeks, compared to a 28% rise in those taking zidovudine and lamivudine.
Fi 398 adult li għandhom esperjenza fit- trattament (li ħadu trattament għall- infezzjoni ta 'l- HIV qabel), VIRAMUNE, flimkien ma' zidovudine u lamivudine, wassal għal tnaqqis ta '38% fil- viral load wara 48 ġimgħa, meta mqabbel ma' żieda ta '28% f' dawk li ħadu zidovudine u lamivudine.
In 151 treatment-naïve patients (who had not taken treatment for HIV infection before), viral loads fell by 99% in the three-medicine group, compared to 96% in the two-medicine group after 40 to 52 weeks.
F' 151 pazjent ġodda għat- trattament (li qatt ma ħadu trattament għall - infezzjoni ta 'HIV qabel), il- viral load waqgħet b' 99% fil- grupp ta' tliet mediċini, meta mqabbel ma '96% fil- grupp ta' żewġ mediċini wara 40 sa 52 ġimgħa.
Adults taking three medicines also had greater rises in CD4 cell counts, and a lower risk of their disease getting worse or dying.
Adulti li kienu qed jieħdu tliet mediċini kellhom ukoll żidiet akbar fl- għadd ta 'ċelloli CD4, u inqas riskju li l- marda tagħhom taggrava jew li jmutu.
Similar results were seen in HIV-1-infected children.
Riżultati simili intwerew fi tfal infettati b' HIV- 1.
What is the risk associated with VIRAMUNE?
X’ inhu r- riskju assoċjat ma 'VIRAMUNE?
The most common side effects when taking VIRAMUNE (seen in between 1 and 10 patients in 100) are rash, allergic reactions, headache, nausea (feeling sick), hepatitis (inflammation of the liver) and signs of liver problems in the blood.
L- aktar effetti sekondarji komuni waqt it- teħid ta ’ VIRAMUNE (li jidhru f' madwar pazjent 1 u 10 f' 100) huma raxx, reazzjonijiet allerġiċi, uġigħ ta 'ras, dardir (tħossok ma tiflaħx), epatite (infjammazzjoni tal- fwied) u sinjali ta' problemi tal- fwied fid- demm.
VIRAMUNE has also been associated with serious side effects, including Stevens-Johnson syndrome and toxic epidermal necrolysis (life-threatening allergic reactions affecting the skin and mucous membranes), serious hepatitis and liver failure, and serious allergic reactions.
VIRAMUNE ġie assoċjat ukoll ma 'effetti sekondarji serji, li jinkludu s- sindromu ta' Stevens- Johnson u nekrosi epiderali tossika (reazzjonijiet allerġiċi li jipperikolaw il- ħajja li jaffettwaw il- ġilda u r- riti mukużi), epatite serja u ħsara epatika, u reazzjonijiet allerġiċi serji.
Patients should be monitored closely for signs of these side effects during the first 18 weeks of treatment, and blood tests for liver problems should be carried out regularly throughout treatment.
Il- pazjenti għandhom jiġu mmonitorjati mill- qrib għal sinjali ta 'dawn l- effetti sekondarji matul l- ewwel 18- il ġimgħa ta' trattament, u testijiet tad- demm għal dawn il- problemi epatiċi għandhom isiru ta 'spiss matul it- trattament.
For the full list of all side effects reported with VIRAMUNE, see the Package Leaflet.
Għal- lista sħiħa ta 'dawn l- effetti sekondarji kollha rrapportati b' VIRAMUNE, ara l- Fuljett ta' Tagħrif.
VIRAMUNE should not be used in people who may be hypersensitive (allergic) to nevirapine or any of the other ingredients, or who have severe problems with their liver or signs of liver problems in the blood.
VIRAMUNE m' għandux jintuża f' persuni li għandhom sensittività eċċessiva (allerġiċi) għal nevirapine jew għal xi waħda mis- sustanzi l- oħra, jew li għandhom problemi severi fil- fwied tagħhom jew sinjali ta 'problemi fil- fwied fid- demm.
It should not be used in patients who are taking St John’ s wort (a herbal preparation used to treat depression).
M' għandux jittieħed minn pazjenti li qed jieħdu St John’ s wort (preparazzjoni erbali użata biex tittratta d- dipressjoni).
Its use in patients taking rifampicin (used to treat tuberculosis) is not recommended.
L- użu tiegħu f' pazjenti li qed jieħdu rifampicin (użat fil- kura ta 'tuberkolożi) mhuwiex rakkomandat.
Treatment with VIRAMUNE should not be started again in patients who have had to stop taking the medicine in the past because of rash, allergic reactions or hepatitis, or who have had signs of liver problems while they were taking VIRAMUNE that returned when the medicine was started again.
It- trattament b 'VIRAMUNE m' għandux jinbeda mill- ġdid f' pazjenti li kellhom bżonn jieqfu jieħdu din il- mediċina fil- passat minħabba raxx, reazzjonijiet allerġiċi jew epatite, jew li kellhom sinjali ta' problemi fil- fwied waqt li kienu qed jieħdu VIRAMUNE, li reġgħu tfaċċaw meta bdew jieħdu l - mediċina mill- ġdid.
Caution is needed when VIRAMUNE is taken at the same time as other medicines.
Il- kawtela hija meħtieġa meta VIRAMUNE jittieħed fl- istess ħin ma 'mediċini l- oħra.
As with other anti-HIV medicines, patients taking VIRAMUNE may be at risk of lipodystrophy (changes in the distribution of body fat), osteonecrosis (death of bone tissue) or immune reactivation syndrome (symptoms of infection caused by the recovering immune system).
Bħal fil- każ ta 'mediċini ta' kontra l- HIV oħra, pazjenti li jieħdu VIRAMUNE jistgħu jkunu f' riskju ta 'lipodistrofija (bidliet fid- distribuzzjoni tal- grass fil- ġisem), osteonekrosi (mewt tat- tessut ta' l- għadam) jew is- sindromu ta 'riattivazzjoni immuni (sintomi ta' infezzjoni kkaġunati mis- sistema immuni li tkun qegħda tirkupra).
Patients who have problems with their liver (including hepatitis B or C infection) may be at an elevated risk of liver damage when taking VIRAMUNE.
Pazjenti li għandhom problemi bil- fwied tagħhom (li jinkludu infezzjoni bl- epatite B jew Ċ) jistgħu jkunu f' riskju akbar ta 'ħsara epatika meta jieħdu VIRAMUNE.
Why has VIRAMUNE been approved?
Għaliex ġie approvat VIRAMUNE?
The Committee for Medicinal products for Human Use (CHMP) decided that VIRAMUNE’ S benefits are greater than its risks as part of combination therapy for the antiviral treatment of HIV-1 infected patients with advanced or progressive immunodeficiency.
Il- Kumitat dwar il- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta 'VIRAMUNE jisbqu r- riskji tiegħu bħala parti minn terapija ta' kombinazzjoni għat- trattament antivirali ta 'pazjenti infettati b' HIV- 1 b' immunodefiċjenza avvanzata jew progressiva.
Most of the experience with VIRAMUNE was in combination with nucleoside reverse transcriptase inhibitors (NRTIs, a type of antiviral medicine).
Il- biċċa l- kbira ta 'l- esperjenza b' VIRAMUNE kienet f' kombinazzjoni ma' impedituri ta 'nucleoside reverse transcriptase (NRTIs, tip ta' mediċina antivirali).
The committee recommended that VIRAMUNE be given marketing authorisation.
Ma kienx hemm biżżejjed evidenza dwar l- użu ta 'trattament ta' kombinazzjoni li jinkludi impeditur tal- protease (tip ieħor ta 'mediċina antivirali) wara
Other information about VIRAMUNE:
trattament b' VIRAMUNE.
The full EPAR for VIRAMUNE can be found here.
Il- kumitat irrakomanda għat- tqegħid fis- suq.
©EMEA 2007
©EMEA 2007 li VIRAMUNE għandu jingħata l- awtorizzazzjoni
This summary was last updated in 02-2007.
L - awtorizzazzjoni għat- tqegħid fis- suq ġiet riveduta fil- 5 ta 'Frar 2003.
EU/ 1/ 97/ 055/ 001
Numru ta ’ l- EU EU/ 1/ 97/ 055/ 001
Viramune
Isem kummerċjali Viramune
200 mg
Qawwa 200 mg
blister (PVC/ alu)
Il- pakkett folja (PVC/ alu)
60 tablets
Daqs tal- pakkett 60 pillola
Oral suspension Tablet Tablet
Suspensjoni orali
bottle (HDPE) blister (PVC/ alu) blister (PVC/ alu)
flixkun (HDPE)
1 bottle + 5 ml measuring syringe 120 tablets 14 tablets
1 flixkun + 5 ml siringa tal- kejl
VIRAMUNE 200 mg tablets
VIRAMUNE 200 mg pilloli
Each tablet contains 200 mg of nevirapine (as anhydrate).
Kull pillola fiha 200 mg ta 'nevirapine (bħala anhydrate).
Excipient: each tablet contains 318 mg of lactose monohydrate.
Sustanza mhix attiva: kull pillola fiha 318 mg ta ’ lactose monohydrate.
White, oval, biconvex tablets.
Pilloli bojod, ovali, u mżaqqa fuq iż- żewġ naħat.
One side is embossed with the code “ 54 193”, with a single bisect separating the “ 54” and “ 193”.
Hemm ukoll xaqq li jaqsam il- pillola bejn l- ewwel parti tal- kodiċi, “ 54 ” u l- parti l- oħra, “ 193 ”.
The opposite side is marked with the company symbol.
In - naħa l- oħra tal- pillola hija mmarkata bl- arma tal- kumpanija.
The tablet should not be divided.
Il- pillola m’ għandiex tinqasam.
VIRAMUNE is indicated in combination with other anti-retroviral medicinal products for the treatment of HIV-1 infected adults, adolescents, and children of any age (see section 4.4.).
VIRAMUNE huwa intiż biex jingħata flimkien ma ’ prodotti mediċinali anti- retrovirali oħra għat - trattament ta ’ adulti, adoloxxenti u tfal ta ’ kwalunkwe età infettati bl- HIV- 1 (ara sezzjoni 4. 4).
Most of the experience with VIRAMUNE is in combination with nucleoside reverse transcriptase inhibitors (NRTIs).
L- aktar esperjenza miksuba b’ VIRAMUNE hija meta tintuża ma ’ impedituri ta 'l- enzima nucleoside reverse transcriptase (NRTI’ s).
The choice of a subsequent therapy after VIRAMUNE should be based on clinical experience and resistance testing (see section 5.1).
L- għażla ta ’ terapija sussegwenti wara VIRAMUNE għandha tkun ibbażżata fuq esperjenza klinika u testijiet ta ’ reżistenza (ara sezzjoni 5. 1)
VIRAMUNE should be administered by physicians who are experienced in the treatment of HIV infection.
VIRAMUNE għandu jingħata minn tobba li għandhom esperjenza fit- trattament ta ’ infezzjonijiet ta ’ l - HIV.
Patients 16 years and older
Pazjenti minn 16- il sena 'l fuq
The recommended dose of VIRAMUNE is one 200 mg tablet daily for the first 14 days (this lead-in period should be used because it has been found to lessen the frequency of rash), followed by one 200 mg tablet twice daily, in combination with at least two additional antiretroviral agents.
Id- doża rakkomandata ta ’ VIRAMUNE hija ta ’ pillola waħda kuljum ta '200 mg għal 14- il jum (dal - perijodu ta ’ introduzzjoni huwa meħtieġ għax instab li titnaqqas l- frekwenza li jitrabba raxx) u wara, għandha tittieħed pillola ta' 200 mg darbtejn kuljum, flimkien ma ’ mill- anqas żewġ sustanzi anti - retrovirali.
Paediatric (adolescent) patients
2 Pazjenti tfal (adoloxxenti)