qanastek/EMEA-V3 huggingface dataset:
It is important to keep your work area, your hands, and the injection site clean to lessen the risk of infection.
Huwa importanti li żżomm il- post fejn taħdem, idejk, u s- sit mnejn tingħata l- injezzjoni nodfa biex tnaqqas ir- riskju ta ’ infezzjoni.
Please follow the 4 major steps below to use the pen.
Jekk jogħġbok segwi l- erba ’ passi maġġuri hawn taħt biex tuża l- pinna.
Mix the medicine Key points:
Ħallat il- mediċina Punti ewlenin:
Before you mix the PegIntron, make sure it is at room temperature.
Qabel tħallat PegIntron, aċċerta ruħek li laħqet it- temperatura tal- kamra.
It is important that you keep the PegIntron pre-filled pen upright (Dosing button down) (as shown in figure 1).
Huwa importanti illi żżomm il- pinna mimlija għal- lest ta ’ PegIntron wieqfa (Sinjal tad- dożaġġ iħares l- isfel) (kif jidher fi stampa 1).
Place the PegIntron 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 ’ PegIntron wieqfa fil - kontenitur tat- trej provdut fil- pakkett (il- buttuna tad- dożaġġ tkun mal- qiegħ) fuq superfiċje iebsa, ċatta, li ma tiżloqx.
You may want to hold the pen using the grip.
Tista ’ żżomm il- pinna mimlija lesta permezz tal- manku.
To mix the powder and the liquid, keep the PegIntron 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 ’ PegIntron 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.
you have heard the click, you will notice in the window that dark stoppers are now touching.
Ladarba tkun smajt it- tfaqqiha, tinnota li fit- twejqa ż- żewġ tappijiet suwed
flush with the pen body.
Buttuna tad - dożaġġ
• •
issa qed imissu.
Wait for several seconds to let the powder dissolve.
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 ’ PegIntron ta ’ taħt fuq għal darbtejn.
DO NOT SHAKE THE PEN.
TĦAWWADX IL- PINNA. • Żomm il- pinna mnimlija għal- lesta ta ’ PegIntron dritta ‘ l fuq, bil -
Dosing button
Ħowlder buttuna tad- dożaġġ l- isfel.
Then, look through the pen window to see that the mixed PegIntron solution is competely dissolved.
Imbagħad ħares lejn s- soluzzjoni ta ’ Stampa 1 PegIntron mit- twejqa biex tara li s- soluzzjoni ta ’ PegIntron imħallta tkun inħallet għall- kollox.
If there is still foam, wait until it settles.
Jekk ikun għad hemm ir- ragħwa, stenna sakemm toqgħod.
The solution should be clear and colourless before use.
Is- soluzzjoni għandha tkun ċara u mingħajr kulur.
Do not use the solution if it is discoloured, not clear, or
Tużax is - soluzzjoni tkun tilfet il- kulur, mhux ċara jew ikun fiha xi frak.
Before attaching the needle, it is normal to see some small bubbles in the pre-filled pen window, near the top of the solution.
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.
Place the pen back into the holder in the tray with the dosing button on the bottom.
Poġġi l- pinna lura fil- ħowlder fit- trej bil- buttuna tad- dożaġġ fil- qiegħ.
Attach the needle
Waqt li żżomm il- pinna mimlija lesta ta ’ PegIntron wieqfa fil - kontenitur provdut fil- pakkett, iddiżinfetta l- membrana tal - lastku tal- pinna mimlija lesta ta ’ PegIntron b‘ biċċa għat- tindif.
Keeping the pen upright in the tray holder, wipe the rubber membrane of the PegIntron pre-filled pen with one cleansing swab.
Ħu l- labra ta ’ l- injezzjoni provduta fit- trej u neħħi l- istrixxa ta ’ l- isterilità li tipproteġiha.
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 ’ PegIntron wieqfa fil- kontenitur, imbotta l- labra ta ’ l- injezzjoni bil- ħlewwa għal fuq il- pinna mimlija lesta u ssikkah sew ġo postu.
Figure 2
Stampa 2
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 ’ PegIntron ‘ L FUQ (buttuna tad- dożaġġ l- isfel) u ħalli ż - żewġ tappijiet tal- labra fuqha sakemm tkun lest/ a għall- injezzjoni.
• Keep the PegIntron 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 may see some liquid trickle out from under the cap, as the air has been expelled out of the pen.
Din hi ħaġa normali.
This is normal. • Wait about 5 seconds for this process to finish. • The dark stoppers move up and you will no longer see the fluid in the window once the needle is successfully primed (figure 3).
Stenna għal madwar 5 sekondi sakemm dan il- proċess jieqaf.
327 Stopper
Tapp
Stopper
Tapp
Check through the window to be sure that the two stoppers are together.
Ħares mit- twejqa biex tiżgura illi ż- żewġ tappijiet qegħdin ma ’ xulxin.
If they are not together, do not use this pen because you may not be able to dial your dose (figure 3).
Jekk m’ humiex ma ’ xulxin, tużax din il - pinna għaliex ma tkunx tista ’ tirregola d- doża tiegħek (stampa 3).
Step 3:
Pass 3:
Set the dose
Irregola d- doża
Take the pen from the tray holder.
Ħu l- pinna mill- ħowlder tat- trej.
Holding the pen firmly, pull the dosing button out as far as it will go, until you see a dark ring on the pen.
Waqt li żżomm b’ fermezza l- pinna, iġbed il- buttuna tad - dożaġġ ‘ l barra kemm ittik, sakemm tara ċirku skur fuq il - pinna.
The dosing button should be easy to pull out without too much force being needed (figure 4).
Il- buttuna tad- dożaġġ għandha tkun tista ’ tinġibed ‘ l barra faċilment mingħajr il- ħtieġa ta ’ saħħa eċċessiva (stampa 4).
Do not push the dosing button back in at this time.
Terġax timbotta l- buttuna tad- dożaġġ lura ‘ l ġewwa f’ dan l- istadju.
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 PegIntron fuqek innifsek.
PegIntron.
Ċirku skur
Turn the dosing button until your prescribed dose is in line with the dosing tab.
Dawwar il- buttuna tad- dożaġġ sakemm id- doża preskritta tiegħek tkun bi dritt mal- marka tad- dożaġġ.
The button should turn easily without too much force being needed (figure 5).
Il- buttuna għandha ddur faċilment mingħajr ma tkun meħtieġa saħħa eċċessiva (stampa 5).
If you have trouble dialing your dose, check to make sure the dosing button has been pulled out as far as it will go.
Jekk ikollok problema biex iddaħħal id- doża tiegħek, aċċerta ruħek li l- buttuna tad- dożaġġ tkun ġbidtha ‘ l barra kemm ittik.
If you cannot easily pull out the dosing button or dial the dose, do not use excessive force and do not use this pen because it may not deliver the correct dose.
Jekk inti ma tistax tiġbed il- buttuna tad- dożaġġ ‘ l barra faċilment jew issib id- doża, tużax saħħa żejda u tużax din il - pinna għaliex tista ’ ma twassalx id- doża korretta.
Figure 5
Stampa 5
Carefully lay the pen down on a hard, flat, non-slip surface.
Qiegħed il- pinna bil- galbu fuq superfiċi iebsa, ċatta, li ma tiżloqx.
DO NOT remove either of the needle caps and DO NOT push the dosing button in until you are ready to self-inject the PegIntron 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 ’ PegIntron.
Inject the PegIntron solution
Injetta s- soluzzjoni ta ’ PegIntron
Select the injection site.
Agħżel is- sit ta ’ l- injezzjoni.
Your doctor will have told you which sites to use (e.g., thigh or abdomen).
It- tabib tiegħek ser ikun qallek liema postijiet għandek tuża (eż. il- koxxa jew l- addome).
The best sites for giving yourself an injection are those areas with a layer of fat between the skin and muscle, like your thigh, the outer surface of your upper arm, and abdomen.
L- aħjar postijiet fejn tinjetta lilek innifsek b’ injezzjoni huma dawk il- partijiet li jkollhom saff ta ’ xaħam bejn il- ġilda u l- muskolu, bħal koxxtejk, in- naħa ta ’ barra ta ’ dirgħajk, jew l- addome.
Do not inject yourself in the area near your navel or waistline.
M’ għandekx tinjetta ruħek fil- parti ta ’ zokortok jew qaddek.
If you are very thin, you should only use the thigh or outer surface of the arm for injection.
Jekk int irqieq/ a ħafna, għandek tuża biss koxxtejk jew in- naħa ta ’ barra ta ’ drigħajk għall- injezzjoni.
You should use a different site each time you inject PegIntron to avoid soreness at any one site.
Għandek tuża post differenti kull darba li tinjetta PegIntron sabiex tevita li tisloħ post wieħed.
Do not inject PegIntron into an area where the skin is irritated, red, bruised, infected, or has scars, stretch marks, or lumps.
M’ għandekx tinjetta PegIntron f’ parti fejn ikollok il- ġilda irritata, ħamra, imbenġla, infettata, jew ikollok xi ċikatriċi, marki tat- tqala, jew għoqod.
Clean the injection site skin with the second cleansing swab provided, and wait for the area to dry.
Naddaf il- post ta ’ l- injezzjoni fil- ġilda bit- tieni biċċa għat- tindif ipprovduta, u stenna sakemm il- parti tkun nixfet.
Outer needle cap
Tapp ta ’ barra tal - labra
Pull off the outer needle cap (figure 6).
Neħħi t- tapp ta ’ barra tal- labra (stampa 6).
There may be some liquid around the inner needle cap.
Jista ’ jkun hemm xi likwidu madwar it- tapp intern tal- labra.
Don’t worry, this is normal.
Tinkwetax, dan hu normali.
This liquid is not part of your dose, it is extra.
Dan il- likwidu m’ huwiex parti mid- doża tiegħek, dan huwa żejjed.
Yellow inner needle cap
Tapp intern isfar tal- labra
Once the injection site is dry, pull off the yellow inner needle cap carefully exposing the injection needle.
Meta jkun niexef il- post ta ’ l- injezzjoni, iġbed it- tapp intern isfar tal- labra bil- mod ħalli tikxef il- labra ta ’ l - injezzjoni.
You are now ready to inject.
Issa lest/ a biex tinjetta.
Figure 6
Stampa 6
Hold the PegIntron 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 ’ PegIntron bis- swaba ’ tiegħek madwar il- kanna tal- pinna u bis- saba ’ l- kbir fuq il - buttuna tad- dożaġġ (stampa 7).
With your other hand, pinch a fold of loose skin in the area you have cleaned for injection.
B’ idek l- oħra, oqros tinja ġilda mpaħpħa fil- parti lit kun naddaft għall- injezzjoni.
Insert the needle into the pinched skin at an angle of 45° to 90°.
Daħħal il- labra ġol- ġilda maqrusa f’ angolu ta ’ bejn 45° u 90°.
Press the dosing button down slowly and firmly until the button can no longer move.
Agħfas il- buttuna tad- dożaġġ ‘ l isfel bil- mod u b’ fermezza sakemm il- buttuna ma tkunx tista ’ tiċċaqlaq iżjed.
Keep your thumb pressed down on the dosing button for an additional 5 seconds to ensure that you get the complete dose.
Żomm subajk il- kbir mgħafus ‘ l isfel fuq il- buttuna tad - dożaġġ għal 5 sekondi oħra sabiex tiżgura illi tieħu d- doża kompleta.
Figure 7
Stampa 7
• Remove the needle from your skin. • Gently press the injection site with a small bandage or sterile gauze if necessary for a few seconds. • Do not massage the injection site.
• Neħħi l- labra minn ġol- ġilda tiegħek. • Agħfas bil- ġentilezza l- post ta ’ l- injezzjoni b’ faxxa żgħira jew garża sterili jekk meħtieġ għal madwar ftit sekondi. • Togħrokx il- post ta ’ l- injezzjoni.
If there is bleeding, cover with an adhesive bandage. • Discard the PegIntron 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 ’ PegIntron bil- labra b’ mod li ma tkunx ta ’ periklu ġo kontenitur magħluq u iebes.
After 2 hours, check the injection site for redness, swelling, or tenderness.
Wara sagħtejn, ħares lejn is- sit ta ’ l- injezzjoni għal ħmura, nefħa, jew tenerezza.
If you have a skin reaction and it doesn’t clear up in a few days, contact your health care professional.
Jekk ikollok reazzjoni tal- ġilda u ma titlaqx fi ftit ġranet, għamel kuntatt mal- professjonist li qed jieħu ħsieb il- kura tas- saħħa tiegħek.
330 PACKAGE LEAFLET:
FULJETT TA ’ TAGĦRIF:
PegIntron 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)
PegIntron 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)
Peg Intron is not recommended for use in patients under the age of 18 years.
PegIntron mhux rakkomandat għall- użu f’ pazjenti li għ andhom taħt it- 18- il sena.
331 Take special care with PegIntron
Oqgħod attent ħafna b 'PegIntron
- If you develop symptoms of a severe allergic reaction (such as d ifficulty in breathing, wheezing, or
- Jekk tiżviluppa sintomi ta ’ reazzjoni allerġika akuta (bħal diffikultà biex tieħu n- nifs, tħarħir jew
332 It is not known whether this product is present in human milk.
Mhux magħruf jekk dan il- prodott joħroġx mal- ħalib tal- mara.
333 In patients who have not responded previously or relapsed, the treatment should continue for one year (contingent upon the response after the first 12 weeks of therapy).
F’ pazjenti li qabel ma kellhomx rispons jew irkadew, il- kura għadha titkompla għal sena waħda (skond ir - rispons wara l- ewwel 12- il ġimgħa ta ’ terapija).
334 blood or clots in stool (or black, tarry stool); fever or chills beginning after a few weeks of treatment, pain in your lower back or side; difficulty or inability to pass urine, painful or inflamed muscles (sometimes severe); problems with your eyes or your eyesight or hearing; severe or painful reddening of your skin or mucous membrane, severe bleeding from your nose.
It- tabib tiegħek jeżaminalek id- demm sabiex jiżgura illi l- għadd taċ- ċelloli bojod fid- demm (ċelloli li jiġġieldu l- infezzjonijiet) u ċ- ċelloli ħomor fid- demm (ċelloli li jġorru l- ossiġnu), il- plejtlets (ċelloli li jgħinu d- demm biex jagħ qad) u riżultati oħra tal- laboratorju jinsabu f’ livelli aċċettabbli.
Very commonly reported side effects (greater than or equal to 1 in every 10 patients):
Effetti sekondarji komuni ħafna li kienu rrappurtati (aktarjew sa 1 f’ kull 10 pazjenti):
Irritation or redness (and rarely, skin damage) at the site of injection, headache, tired feeling, shaking chills, fever, flu -like symptoms, weakness, loss of weight, nausea, loss of appetite, diarrhoea or loose stools, stomach pain, vomiting, muscle aches, pain in joints and muscles, feeling depressed, irritability, trouble falling asleep or staying asleep, feeling anxious or nervous, difficulty concentrating, mood swings, hair loss, itching, dry skin, sore throat, coughing, difficult breathing, dizziness, virus infection, rash, and dry mouth.
Irritazzjoni u ħmura (u rari ħsara fil- ġilda) fis- sit ta ’ l- injezzjoni, uġigħ ta ’ ras, sensazzjoni ta ’ għejja, dehxiet, deni, sintomi bħal ta ’ l- influwenza, dgħufija, telf ta ’ piż, tqallih, nuqqas ta’ aptit, dijarrea jew ippurgar maħlul, uġigħ fl- istonku, rimettar, weġgħ at fil- muskoli, uġigħ fil- ġogi u fil- muskoli, sensazzjoni ta ’ depressjoni, irritabbilità, problema biex torqod jew tibqa ’ rieqed, sensazzjoni ta ’ ansjetà jew nervużiżmu, diffikultà biex tikkonċentra, bidliet fil- burdati, telf ta ’ xagħar, ħakk, ġilda xotta, uġigħ fil - griżmejn, sogħla, diffikultà biex tieħu n- nifs, sturdament, infezzjoni virali, raxx, u ħalq xott.
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’ PegIntron: palsi tal- wiċċ (dgħjufija u naħa waħda tal- wiċċ jitgħawweġ) u reazzjonijiet allerġiċi severi bħal anġjoedema (marda allerġika tal- ġilda li l - karatteristika tagħha hija dbabar ta ’ nefħa ċirkomċiża li tinvolvi l- ġilda u s- saffi ta ’ taħtha, il- membrani mukużi, u kultant l- organi interni), nekroliżi tossika ta ’ l- epidermide/ Sindrome ta ’ Stevens Johnson/ erythema multiforme (medda ta ’ raxxijiet b’ gradi varji ta ’ severità inkluża l- mewt li tista ’ tkun assoċjata ma ’ bżieżaq fil- ħalq, imnieħer, għajnejn u membrani mukużi oħrajn u tinqala l- ġilda tal- parti affettwata), manija (entużjażnu eċċessiv jew bla- raġuni), disturbi bipolari (disturbi fil- burdati li l - karatteristika tagħhom hija episodji li jalternaw bejn dwejjaq u eċitament), effużjoni perikardijaka (jinġabar fluwidu bejn il perikardju (rita mad- dawra tal- qalb) u l- qalb innifisha), perikardite (infjammazzjoni tar- rita tal- qalb).
After administering the dose, discard the PegIntron pre-filled pen and any unused solution contained in it.
Armi kwalunkwe materjal li jibqa.
336 The white powder and the clear and colourless solvent are both contained in a two-chamber glass cartridge assembled into a single use pre-filled pen.
It- trab abjad u s- solvent ċar u mingħajr kulur it- tnejn jinsabu ġo skartoċċ tal- ħġieġ b’ żewġ kompartimenti imdaħħal ġo pinna mimlija għal- lest li tintuża darba biss.
PegIntron 80 micrograms is available in different pack sizes:
PegIntron 80 mikrogrammi huwa disponibbli f’ pakketti ta ’ daqsijiet differenti:
338 ANNEX TO THE PACKAGE LEAFLET
ANNESS GĦALL- FULJETT TA ’ TAGĦ RIF
Preparation: a.
Preparazzjoni: e.
This is the PegIntron which will be mixed with liquid inside the pen before it is injected. d.
Dan huwa il - PegIntron li se jitħallat mal- likwidu fil- pinna qabel ma tiġi injettata. h.
you have heard the click, you will notice in the window that
Ladarba tkun smajt it- tfaqqiha, tinnota li fit- twejqa ż- żewġ tappijiet suwed
Dosing
Buttuna tad - dożaġġ
dark stoppers are now touching.
issa qed imissu.
The dosing button should be
TĦAWWADX IL- PINNA. • Żomm il- pinna mnimlija għal- lesta ta ’ PegIntron dritta ‘ l fuq, bil -
button
Ħowlder buttuna tad- dożaġġ l- isfel.
Figure 1
Imbagħad ħares lejn s- soluzzjoni ta ’ Stampa 1 PegIntron mit- twejqa biex tara li s- soluzzjoni ta ’ PegIntron imħallta tkun inħallet għall- kollox.
SHAKE THE PEN. • Keep the PegIntron 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 PegIntron solution is competely dissolved.
Tużax is - soluzzjoni tkun tilfet il- kulur, mhux ċara jew ikun fiha xi frak.
If there is still foam, wait until it settles. • The solution should be clear and colourless before use.
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.
Attach the needle
Pass 2: Waħħal l- labra
Keeping the pen upright in the tray holder, wipe the rubber membrane of the PegIntron pre-filled pen with one cleansing swab.
Waqt li żżomm il- pinna mimlija lesta ta ’ PegIntron wieqfa fil - kontenitur provdut fil- pakkett, iddiżinfetta l- membrana tal - lastku tal- pinna mimlija lesta ta ’ PegIntron b‘ biċċa għat- tindif.
340 Stopper
Tapp
You will push it in when you are ready to self-inject the PegIntron.
Ser timbuttaha ‘ l ġewwa meta tkun lest/ a biex tinjetta PegIntron fuqek innifsek.
Dark ring
Ċirku skur
Hold the PegIntron 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 ’ PegIntron 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 PegIntron 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 ’ PegIntron bil- labra b’ mod li ma tkunx ta ’ periklu ġo kontenitur magħluq u iebes.
343 PACKAGE LEAFLET:
FULJETT TA ’ TAGĦRIF:
PegIntron 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)
PegIntron 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)
What Peg Intron is and what it is used for 2.
X’ inhu PegIntron u għalxiex jintuża 2.
344 Take special care with PegIntron
Oqgħod attent ħafna b 'PegIntron
345 It is not known whether this product is present in human milk.
Mhux magħruf jekk dan il- prodott joħroġx mal- ħalib tal- mara.
346 In patients who have not responded previously or relapsed, the treatment should continue for one year (contingent upon the response after the first 12 weeks of therapy).
F’ pazjenti li qabel ma kellhomx rispons jew irkadew, il- kura għadha titkompla għal sena waħda (skond ir - rispons wara l- ewwel 12- il ġimgħa ta ’ terapija).
347 blood or clots in stool (or black, tarry stool); fever or chills beginning after a few weeks of treatment, pain in your lower back or side; difficulty or inability to pass urine, painful or inflamed muscles (sometimes severe); problems with your eyes or your eyesight or hearing; severe or painful reddening of your skin or mucous membrane, severe bleeding from your nose.
It- tabib tiegħek jeżaminalek id- demm sabiex jiżgura illi l- għadd taċ- ċelloli bojod fid- demm (ċelloli li jiġġieldu l- infezzjonijiet) u ċ- ċelloli ħomor fid- demm (ċelloli li jġorru l- ossiġnu), il- plejtlets (ċelloli li jgħinu d- demm biex jagħ qad) u riżultati oħra tal- laboratorju jinsabu f’ livelli aċċettabbli.
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’ PegIntron: palsi tal- wiċċ (dgħjufija u naħa waħda tal- wiċċ jitgħawweġ) u reazzjonijiet allerġiċi severi bħal anġjoedema (marda allerġika tal- ġilda li l - karatteristika tagħha hija dbabar ta ’ nefħa ċirkomċiża li tinvolvi l- ġilda u s- saffi ta ’ taħtha, il- membrani mukużi, u kultant l- organi interni), nekroliżi tossika ta ’ l- epidermide/ Sindrome ta ’ Stevens Johnson/ erythema multiforme (medda ta ’ raxxijiet b’ gradi varji ta ’ severità inkluża l- mewt li tista ’ tkun assoċjata ma ’ bżieżaq fil- ħalq, imnieħer, għajnejn u membrani mukużi oħrajn u tinqala l- ġilda tal- parti affettwata), manija (entużjażnu eċċessiv jew bla- raġuni), disturbi bipolari (disturbi fil- burdati li l - karatteristika tagħhom hija episodji li jalternaw bejn dwejjaq u eċitament), effużjoni perikardijaka (jinġabar fluwidu bejn il perikardju (rita mad- dawra tal- qalb) u l- qalb innifisha), perikardite (infjammazzjoni tar- rita tal- qalb).
349 The white powder and the clear and colourless solvent are both contained in a two-chamber glass cartridge assembled into a single use pre-filled pen.
It- trab abjad u s- solvent ċar u mingħajr kulur it- tnejn jinsabu ġo skartoċċ tal- ħġieġ b’ żewġ kompartimenti imdaħħal ġo pinna mimlija għal- lest li tintuża darba biss.
PegIntron 100 micrograms is available in different pack sizes:
PegIntron 100 mikrogrammi huwa disponibbli f’ pakketti ta ’ daqsijiet differenti:
351 ANNEX TO THE PACKAGE LEAFLET
ANNESS GĦALL- FULJETT TA ’ TAGĦ RIF
Preparation: a.
Preparazzjoni: i.
This is the PegIntron which will be mixed with liquid inside the pen before it is injected. d.
Dan huwa il - PegIntron li se jitħallat mal- likwidu fil- pinna qabel ma tiġi injettata. l.
353 Stopper
Tapp
DO NOT remove either of the needle caps and DO NOT push the dosing button in until you are ready to self -inject the PegIntron 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 ’ PegIntron.
356 PACKAGE LEAFLET:
FULJETT TA ’ TAGĦRIF:
PegIntron 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)
PegIntron 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)
Storing Peg Intron 6.
Kif taħżen PegIntron 6.
357 Take special care with PegIntron
Oqgħod attent ħafna b 'PegIntron
358 It is not known whether this product is present in human milk.
Mhux magħruf jekk dan il- prodott joħroġx mal- ħalib tal- mara.
359 In patients who have not responded previously or relapsed, the treatment should continue for one year (contingent upon the response after the first 12 weeks of therapy).
F’ pazjenti li qabel ma kellhomx rispons jew irkadew, il- kura għadha titkompla għal sena waħda (skond ir - rispons wara l- ewwel 12- il ġimgħa ta ’ terapija).
Detailed instructions for subcutaneous administration are provided with this leaflet (see How to use the PegIntron pre -filled pen).
Istruzzjonijiet dettaljati għall- għotja minn taħt il- ġilda huma provduti ma ’ dan il- fuljett (ara Kif tinjetta PegIntron fuqek innifsek fl- aħħar tal - fuljett ta ’ tagħrif).
360 blood or clots in stool (or black, tarry stool); fever or chills beginning after a few weeks of treatment, pain in your lower back or side; difficulty or inability to pass urine, painful or inflamed muscles (sometimes severe); problems with your eyes or your eyesight or hearing; severe or painful reddening of your skin or mucous membrane, severe bleeding from your nose.
It- tabib tiegħek jeżaminalek id- demm sabiex jiżgura illi l- għadd taċ- ċelloli bojod fid- demm (ċelloli li jiġġieldu l- infezzjonijiet) u ċ- ċelloli ħomor fid- demm (ċelloli li jġorru l- ossiġnu), il- plejtlets (ċelloli li jgħinu d- demm biex jagħ qad) u riżultati oħra tal- laboratorju jinsabu f’ livelli aċċettabbli.
Additionally, the following events have been reported with PegIntron: 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’ PegIntron: palsi tal- wiċċ (dgħjufija u naħa waħda tal- wiċċ jitgħawweġ) u reazzjonijiet allerġiċi severi bħal anġjoedema (marda allerġika tal- ġilda li l - karatteristika tagħha hija dbabar ta ’ nefħa ċirkomċiża li tinvolvi l- ġilda u s- saffi ta ’ taħtha, il- membrani mukużi, u kultant l- organi interni), nekroliżi tossika ta ’ l- epidermide/ Sindrome ta ’ Stevens Johnson/ erythema multiforme (medda ta ’ raxxijiet b’ gradi varji ta ’ severità inkluża l- mewt li tista ’ tkun assoċjata ma ’ bżieżaq fil- ħalq, imnieħer, għajnejn u membrani mukużi oħrajn u tinqala l- ġilda tal- parti affettwata), manija (entużjażnu eċċessiv jew bla- raġuni), disturbi bipolari (disturbi fil- burdati li l - karatteristika tagħhom hija episodji li jalternaw bejn dwejjaq u eċitament), effużjoni perikardijaka (jinġabar fluwidu bejn il perikardju (rita mad- dawra tal- qalb) u l- qalb innifisha), perikardite (infjammazzjoni tar- rita tal- qalb).
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 ’ PegIntron kienet irrappurtata s- sindrome ta ’ Vogt- Koyanagi- Harada (marda awto- immunitarja infjammatorja li teffettwa l- għajnejn, il- ġilda u l- membrani tal- widnejn, moħħ u s - sinsla).
The white powder and the clear and colourless solvent are both contained in a two-chamber glass cartridge assembled into a single use pre-filled pen.
It- trab abjad u s- solvent ċar u mingħajr kulur it- tnejn jinsabu ġo skartoċċ tal- ħġieġ b’ żewġ kompartimenti imdaħħal ġo pinna mimlija għal- lest li tintuża darba biss.
PegIntron 120 micrograms is available in different pack sizes:
PegIntron 120 mikrogrammi huwa disponibbli f’ pakketti ta ’ daqsijiet differenti:
364 ANNEX TO THE PACKAGE LEAFLET
ANNESS GĦALL- FULJETT TA ’ TAGĦ RIF
Preparation: a.
Preparazzjoni: m.
This is the PegIntron which will be mixed with liquid inside the pen before it is injected. d.
Dan huwa il - PegIntron li se jitħallat mal- likwidu fil- pinna qabel ma tiġi injettata. p.
366 Stopper
Tapp
You will push it in when you are ready to self -inject the PegIntron.
Ser timbuttaha ‘ l ġewwa meta tkun lest/ a biex tinjetta PegIntron fuqek innifsek.
Carefully lay the pen down on a hard, flat, non -slip surface.
Qiegħed il- pinna bil- galbu fuq superfiċi iebsa, ċatta, li ma tiżloqx.
Your doct or will have told you which sites to use (e.g., thigh or abdomen).
It- tabib tiegħek ser ikun qallek liema postijiet għandek tuża (eż. il- koxxa jew l- addome).
Pull off the outer needle cap (figure 6).
Tapp ta ’ barra tal - labra
You are
Meta jkun niexef il- post ta ’ l- injezzjoni, iġbed it- tapp intern isfar tal- labra bil- mod ħalli tikxef il- labra ta ’ l - injezzjoni.
Yellow inner needle cap
Issa lest/ a biex tinjetta.
Hold the Peg Intron 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 ’ PegIntron bis- swaba ’ tiegħek madwar il- kanna tal- pinna u bis- saba ’ l- kbir fuq il - buttuna tad- dożaġġ (stampa 7).
369 PACKAGE LEAFLET:
FULJETT TA ’ TAGĦRIF:
PegIntron 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)
PegIntron 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)
- If you have advanced, uncontrolled liver disease (o ther than hepatitis C).
- Jekk għandek mard fil- fwied avvanzat u mhux ikkontrollat (barra mill- epatite Ċ).
370 Take special care with PegIntron
Oqgħod attent ħafna b 'PegIntron
371 It is not known whether this product is present in human milk.
Mhux magħruf jekk dan il- prodott joħroġx mal- ħalib tal- mara.
372 In patients who have not responded previously or relapsed, the treatment should continue for one year (contingent upon the response after the first 12 weeks of therapy).
F’ pazjenti li qabel ma kellhomx rispons jew irkadew, il- kura għadha titkompla għal sena waħda (skond ir - rispons wara l- ewwel 12- il ġimgħa ta ’ terapija).
373 blood or clots in stool (or black, tarry stool); fever or chills beginning after a few weeks of treatment, pain in your lower back or side; difficulty or inability to pass urine, painful or inflamed muscles (sometimes severe); problems with your eyes or your eyesight or hearing; severe or painful reddening of your skin or mucous membrane, severe bleeding from your nose.
It- tabib tiegħek jeżaminalek id- demm sabiex jiżgura illi l- għadd taċ- ċelloli bojod fid- demm (ċelloli li jiġġieldu l- infezzjonijiet) u ċ- ċelloli ħomor fid- demm (ċelloli li jġorru l- ossiġnu), il- plejtlets (ċelloli li jgħinu d- demm biex jagħ qad) u riżultati oħra tal- laboratorju jinsabu f’ livelli aċċettabbli.
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 ’ PegIntron kienet irrappurtata s- sindrome ta ’ Vogt- Koyanagi- Harada (marda awto- immunitarja infjammatorja li teffettwa l- għajnejn, il- ġilda u l- membrani tal- widnejn, moħħ u s - sinsla).
PegIntron 150 micrograms is available in different pack sizes:
PegIntron 150 mikrogrammi huwa disponibbli f’ pakketti ta ’ daqsijiet differenti:
Marketing Authorisation Holder and Manufacturer
Id- Detentur ta ’ l- Awtorizzazzjoni għ at- tqegħid fis- Suq u l- Manifattur Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq:
377 ANNEX TO THE PACKAGE LEAFLET
ANNESS GĦALL- FULJETT TA ’ TAGĦ RIF
Preparation: a.
Preparazzjoni: q.
This is the PegIntron which will be mixed with liquid inside the pen before it is injected. d.
Dan huwa il - PegIntron li se jitħallat mal- likwidu fil- pinna qabel ma tiġi injettata. t.
379 Stopper
Tapp
What is Pelzont?
X' inhu Pelzont?
Pelzont is a medicine containing two active substances: nicotinic acid (also known as niacin or vitamin B3) and laropiprant.
Pelzont huwa mediċina li fiha żewġ sustanzi attivi: aċidu nikotiniku (magħruf ukoll bħala nijaċina [niacin] jew vitamina B3) u laropiprant.
It is available as modified-release tablets. ‘ Modified-release ’ means that the two active substances are released at different rates from the tablet over a few hours.
'Rilaxx modifikat' tfisser li ż- żewġ sustanzi attivi jiġu rilaxxati b' rati differenti mill- pillola fuq perjodu ta 'ftit sigħat.
What is Pelzont used for?
Għalxiex jintuża Pelzont?
Pelzont is used in addition to diet and exercise in patients with dyslipidaemia (abnormally high levels of fat in the blood), particularly ‘ combined mixed dyslipidaemia’ and ‘ primary hypercholesterolaemia’.
Pelzont jintuża flimkien mad- dieta u l- eżerċizzju fiżiku f' pazjenti b' dislipidemija (livelli għoljin b' mod anomalu ta 'xaħam fid- demm), b' mod partikolari' dislipidemija kombinata mħallta 'u' iperkolesterolemija primarja '.
Patients with combined mixed dyslipidaemia have high blood levels of ‘ bad’ LDL cholesterol and triglycerides (a type of fat), and low levels of ‘ good’ HDL cholesterol.
Il- pazjenti b' dislipidemja kombinata mħallta jkollhom livelli għoljin ta 'kolesterol LDL' ħażin 'u ta' trigliċeridi (tip ta 'xaħam), u livelli baxxi ta' kolesterol 'tajjeb' HDL fid - demm.
Primary hypercholesterolaemia is when the levels of cholesterol in the blood are high.
L- iperkolesterolemija primarja sseħħ meta l- livelli ta 'kolesterol fid- demm ikunu għoljin.
Primary means that the hypercholesterolaemia does not have any identifiable cause.
Primajru tfisser li l- iperkolesterolemija ma jkollhiex kawża identifikabbli.
Pelzont is normally given together with a statin (the standard medicine used to reduce cholesterol) when the effectiveness of a statin taken alone is inadequate.
Pelzont normalment jingħata flimkien ma 'statina (statin, il- mediċina standard użata għat- tnaqqis tal - kolesterol) meta l- effikaċja ta' l- istatina meħuda waħedha ma jkunx biżżejjed.
Pelzont is used on its own only in patients who cannot take statins.
Pelzont jintuża waħdu biss f' pazjenti li ma jkunux jistgħu jieħdu statini.
How is Pelzont used?
Kif jintuża Pelzont?
The starting dose of Pelzont is one tablet once a day for four weeks, after which the dose is increased to two tablets once a day.
Wara, id- doża tiżdied għal żewġ pilloli darba kuljum.
It is taken by mouth, with food, in the evening or before going to bed.
Il- mediċina tittieħed oralment, ma 'l- ikel filgħaxija jew qabel l- irqad.
The tablets must be swallowed whole, and should not be split, broken, crushed or chewed.
Il- pilloli għandhom jinbelgħu sħaħ, u l- pazjent ma għandux jaqsamhom, ikissirhom, ifarrakhom jew jomgħodhom.
Pelzont is not recommended for use in children under 18 years of age because of a lack of information on its safety and effectiveness in this group.
Pelzont mhuwiex rakkomandat għall- użu fi tfal ta 'inqas minn 18- il sena minħabba nuqqas ta' tagħrif dwar is- sigurtà u l- effikaċja tiegħu f' dan il- grupp.
It should be used with caution in patients who have problems with their kidneys and should not be used in patients with liver problems.
Il- mediċina għandha tintuża b' kawtela f' pazjenti li jkollhom problemi fil- kliewi u ma għandhiex tintuża f' pazjenti bil- problemi fil- fwied.
How does Pelzont work?
Kif jaħdem Pelzont?
The two active substances in Pelzont, nicotinic acid and laropiprant, have different modes of action.
Iż- żewġ sustanzi attivi f' Pelzont, aċidu nikotiniku u laropiprant, għandhom modi differenti ta 'azzjoni.
Nicotinic acid is a naturally occurring substance that is used in low doses as a vitamin.
L- aċidu nikotiniku huwa sustanza naturali li tintuża f' dożi baxxi bħala vitamina.
In higher doses, it reduces the levels of fat in the blood via a mechanism that is not fully understood.
F' dożi ogħla, inaqqas il- livelli ta 'xaħam fid- demm b' mekkaniżmu li għadu mhux mifhum għal kollox.
It was first used as a medicine to modify blood fat levels in the mid-1950s, but its use has been limited because of its side effects, particularly flushing (reddening of the skin).
F' nofs is- snin ħamsin,
Reproduction is authorised provided the source is acknowledged.
Reproduction is authorised provided the source is acknowledged. kien jintuża bħala mediċina biex jibdel il- livelli tax- xaħam fid- demm, iżda l- użu tiegħu kien limitat minħabba l- effetti sekondarji, b' mod partikolari l- ħmura fil- ġilda tal- wiċċ.
Flushing due to nicotinic acid is thought to occur because of the release of a substance called ‘ prostaglandin D2’ (PGD2) from cells in the skin, which dilates (widens) the blood vessels in the skin.
Huwa maħsub li l- ħmura fil- wiċċ minħabba l- aċidu nikotiniku sseħħ minħabba r- rilaxx ta 'sustanza magħrufa bħala' prostaglandina D2 '(PGD2) minn ċelluli fil- ġilda, li twessa' l- arterji u l- vini fil- ġilda.
Laropiprant blocks the receptors to which PGD2 normally attaches.
Laropiprant jimblokka r- riċetturi li normalment jeħel magħhom il- PGD2.
When the receptors are blocked, PGD2 cannot dilate the vessels in the skin, reducing the frequency and intensity of flushing.
Meta r- riċetturi jiġu mblukkati, il- PGD2 ma jkunx jista 'jwessa' l- arterji u l- vini fil- ġilda, u jnaqqas il- frekwenza u l - intensità tal- ħmura fil- wiċċ.
In Pelzont tablets, laropiprant is in one of the layers, and the other layer contains nicotinic acid.
Fil- pilloli ta 'Pelzont, laropiprant jinsab f' wieħed mis- saffi, u s- saff l- ieħor fih l- aċidu nikotiniku.
When the patient takes the tablet, laropiprant is released first into the bloodstream and blocks the PGD2 receptors.
Meta l- pazjent jieħu l- pillola, laropiprant jiġi rilaxxat l- ewwel fiċ- ċirkolazzjoni tad- demm u jimblokka r - riċetturi tal- PGD2.
The nicotinic acid is released more slowly from the other layer and has its effect as a fat- modifying agent.
L- aċidu nikotiniku jiġi rilaxxat iktar bil- mod mis- saff l- ieħor u għandu l- effett tiegħu bħala sustanza li timmodifika x- xaħam.
How has Pelzont been studied?
Kif ġie studjat Pelzont?
The effects of Pelzont were first tested in experimental models before being studied in humans.
L- effetti ta 'Pelzont għall- ewwel ġew ittestjati f' mudelli sperimentali qabel ma ġew studjati fuq il - bniedem.
Pelzont was studied in four main studies in patients with hypercholesterolaemia or mixed dyslipidaemia.
Pelzont ġie studjat f' erba 'studji ewlenin b' iperkolesterolemija jew b' dislipidemja mħallta.
Two studies looked at the effectiveness of Pelzont in modifying blood fat levels.
Żewġ studji eżaminaw l- effikaċja ta 'Pelzont fil- modifikazzjoni tal- livelli tax- xaħam fid- demm.
The first study compared the effectiveness of Pelzont with that of nicotinic acid alone or placebo (a dummy treatment) in reducing the levels of LDL cholesterol in a total of 1,613 patients.
L - ewwel studju qabbel l- effikaċja ta 'Pelzont ma' dik ta 'l- aċidu nikotiniku jew tal- plaċebo (trattament finta) fit- tnaqqis tal- livelli ta' kolesterol LDL f' total ta '1, 613- il pazjent.
This study also looked at the symptoms of flushing using a specially designed questionnaire.
Dan l- istudju eżamina wkoll is- sintomi tal- ħmura fil- wiċċ bl- użu ta 'kwestjonarju mfassal apposta.
The second study compared the combination of Pelzont and simvastatin (a statin) with Pelzont alone or simvastatin alone in 1,398 patients.
It- tieni studju qabbel il- kombinazzjoni ta 'Pelzont u simvastatina (statina) ma' Pelzont waħdu jew simvastatina waħedha f' 1, 398 pazjent.
The main measure of effectiveness was the change in the blood levels of LDL cholesterol after 12 weeks.
Il- mezz ewlieni tal- kejl ta 'l- effikaċja kien it- tibdil fil- livelli fid - demm ta' kolesterol LDL wara 12- il ġimgħa.
The third and fourth studies looked at the effectiveness of laropiprant in reducing the flushing caused by nicotinic acid.
It- tielet u r- raba 'studji eżaminaw l- effikaċja ta' laropiprant fit- tnaqqis fil- ħmura fil- wiċċ ikkawżata mill- aċidu nikotiniku.
They included a total of 2,349 patients who were taking either Pelzont or nicotinic acid.
F' dawn b' kollox ħadu sehem 2, 349 pazjent li kienu qegħdin jieħdu Pelzont jew aċidu nikotiniku.
Flushing was measured using the flushing symptom questionnaire.
Il- ħmura fil- wiċċ tkejlet bl- użu ta 'kwestjonarju dwar is- sintomi tal- ħmura fil- wiċċ.
What benefit has Pelzont shown during the studies?
Liema benefiċċju wera Pelzont waqt l- istudji mwettqa?
Pelzont was effective in reducing the blood levels of LDL cholesterol.
Pelzont irriżulta effikaċi fit- tnaqqis tal- livelli ta 'kolesterol LDL fid- demm.
In the first study, LDL cholesterol levels were reduced by 19% in patients taking Pelzont, compared with 1% in those taking placebo.
Fl- ewwel studju, il- livelli ta 'kolesterol LDL tnaqqsu bi 19% fil- pazjenti li kienu qed jieħdu Pelzont, meta mqabbla ma' 1% f' dawk li kienu qed jieħdu l- plaċebo.
The second study showed that the LDL cholesterol levels were further reduced when Pelzont was taken with simvastatin (48% reduction), compared with Pelzont alone (17% reduction) or simvastatin alone (37% reduction).
It- tieni studju wera li l- livelli ta 'kolesterol LDL tnaqqsu iktar meta Pelzont ittieħed flimkien mas- simvastatina (tnaqqis ta' 48%), milli meta Pelzont ittieħed waħdu (tnaqqis ta '17%) jew mas- simvastatina waħedha (tnaqqis ta' 37%).
Adding laropiprant to nicotinic acid reduced the symptoms of flushing caused by nicotinic acid.
Iż- żieda ta 'laropiprant ma' l- aċidu nikotoniku naqset is- sintomi tal- ħmura fil- wiċċ ikkawżata mill - aċidu nikotiniku.
In the first and third studies, fewer patients taking Pelzont reported moderate, severe or extreme flushing than patients taking nicotinic acid alone.
Fl- ewwel u t- tielet studju, inqas pazjenti li kienu qegħdin jieħdu Pelzont rrappurtaw ħmura fil- wiċċ moderata, gravi jew estrema meta mqabbla ma 'pazjenti li kienu qed jieħdu l- aċidu nikotiniku biss.
In the fourth study, flushing was seen on fewer days in patients taking Pelzont than in those taking nicotinic acid alone.
Fir- raba 'studju, il- ħmura fil- wiċċ dehret f' inqas jiem fil- pazjenti li kienu qegħdin jieħdu Pelzont milli f' dawk li kienu qegħdin jieħdu aċidu nikotiniku waħdu.
What is the risk associated with Pelzont?
X' inhu r- riskju assoċjat ma 'Pelzont?
The most common side effect with Pelzont (seen in more than 1 patient in 10) is flushing.
L- iktar effetti sekondarji komuni b' Pelzont (li dehru f' iktar minn pazjent wieħed minn kull 10) huwa l - ħmura fil- wiċċ.
For the full list of all side effects reported with Pelzont, see the Package Leaflet.
Għal- lista sħiħa ta 'effetti sekondarji kollha rrappurtata b' Pelzont, ara l- Fuljett ta' Tagħrif.
Pelzont should not be used in people who may be hypersensitive (allergic) to nicotinic acid, laropiprant or any of the other ingredients.
Pelzont ma għandux jintuża f' persuni li jistgħu jkunu ipersensittivi (allerġiċi) għall- aċidu nikotiniku, laropiprant jew għal xi sustanza oħra tiegħu.
It should also not be used in patients who have problems with their liver, an active stomach ulcer or bleeding from an artery.
Lanqas ma għandu jintuża f' pazjenti bi problemi fil - fwied, b' ulċera attiva fl- istonku jew bi fsada minn arterja.
Why has Pelzont been approved?
Għaliex ġie approvat Pelzont?
The Committee for Medicinal Products for Human Use (CHMP) decided that Pelzont’ s benefits are greater than its risks for the treatment of dyslipidaemia, particularly in patients with combined mixed dyslipidaemia and in patients with primary hypercholesterolaemia.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta 'Pelzont huma ogħla mir- riskji tiegħu għat- trattament tad- dislipidemija, b' mod partikolari f' pazjenti b' dislipidemija kombinata mħallta u f' pazjenti b' iperkolesterolemija primarja.
The Committee recommended that Pelzont be given marketing authorisation.
Il- Kumitat irrakkomanda li Pelzont jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Pelzont:
Informazzjoni oħra dwar Pelzont:
The European Commission granted a marketing authorisation valid throughout the European Union for Pelzont to Merck Sharp & Dohme Ltd. on 3 July 2008.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq fl- Unjoni Ewropea, għal Pelzont lil Merck Sharp & Dohme Ltd. fl- 14 ta 'Lulju 2008.
The full EPAR for Pelzont can be found here.
2/ 3 L- EPAR sħiħ għal Pelzont jista 'jiġi kkonsultat hawn.
Modified-release tablet Modified-release tablet Modified-release tablet Modified-release tablet Modified-release tablet Modified-release tablet Modified-release tablet Modified-release tablet Modified-release tablet Modified-release tablet Modified-release tablet Modified-release tablet Modified-release tablet Modified-release tablet
Pillola b’ rilaxx modifikat Pillola b’ rilaxx modifikat Pillola b’ rilaxx modifikat Pillola b’ rilaxx modifikat Pillola b’ rilaxx modifikat Pillola b’ rilaxx modifikat Pillola b’ rilaxx modifikat Pillola b’ rilaxx modifikat
Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use
Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali
blister (Aclar/ PVC) blister (Aclar/ PVC) blister (Aclar/ PVC) blister (Aclar/ PVC) blister (Aclar/ PVC) blister (Aclar/ PVC) blister (Aclar/ PVC) blister (Aclar/ PVC) blister (alu/ alu) blister (alu/ alu) blister (alu/ alu) blister (Aclar/ PVC) blister (alu/ alu) blister (alu/ alu)
folja (Aclar/ PVC) folja (Aclar/ PVC) folja (Aclar/ PVC) folja (Aclar/ PVC) folja (Aclar/ PVC) folja (Aclar/ PVC) folja (Aclar/ PVC) folja (Aclar/ PVC)
14 tablets 28 tablets 56 tablets 84 tablets 98 tablets 168 tablets 196 tablets 49 x 1 tablets (unit dose) 14 tablets 28 tablets 56 tablets 196 (2 x 98) tablets 168 tablets 32 x 1 tablets (unit dose)
14- il pillola 28 pillola 56 pillola 84 pillola 98 pillola 168 pillola 196 pillola 49 x 1 pillola (doża waħda)