qanastek/EMEA-V3 huggingface dataset:
20 • have severe liver or kidney disease
• għandek mard serju tal- fwied jew tal- kliewi
• have acute inflammation of the pancreas or pericardium (the sac surrounding the heart), or an infection of the heart muscle (bacterial endocarditis)
• għandek infjammazzjoni akuta fil- frixa (pankreas) jew perikardju (ir- rita ta ’ madwar il- qalb), jew infezzjoni fil- muskolu tal- qalb (endokardite tal- batterji)
• have in the past 3 months had severe bleeding, a major injury or major surgery (e. g. coronary artery bypass graft, or surgery or injury to the head or spine), given birth, or had an organ biopsy or other medical / surgical procedure.
• kellek ħruġ tad- demm serju fl- aħħar 3 xhur, ferita serja jew operazzjoni serja (eż. ‘ bypass graft ’ ta ’ l- arterja koronarja, jew operazzjoni jew ferita fir- ras jew fis- sinsla tad- dahar), wellidt, jew kellek bijopsija ta ’ xi organu jew xi proċedura medika / operazzjoni oħra.
Take special care with Rapilysin:
Oqgħod attent ħafna b’ Rapilysin:
The most common side effect of Rapilysin is bleeding.
L- aktar effett komuni sekondarju ta ’ Rapilysin huwa l- ħruġ tad- demm.
Therefore Rapilysin must be given only in the presence and under the instructions of an emergency doctor.
Għalhekk Rapilysin għandu jingħata biss fil- preżenza u taħt l- istruzzjonijiet ta ’ tabib ta ’ l- emergenza.
Pay careful attention to all possible bleeding sites (e. g. injection sites).
Oqgħod partikularment attent/ a għall- ħruġ tad- demm kollu possibbli f’ xi parti tal- ġisem (eż. partijiet fejn saret xi injezzjoni).
Heparin, which is given together with Rapilysin, may also increase bleeding.
L- eparina, li hija mogħtija flimkien ma ’ Rapilysin, tista ’ żżid il- ħruġ tad - demm ukoll.
The risks of Rapilysin treatment may be increased if you have any of the following conditions: • diseases of the blood vessels in the brain
Ir- riskji bit- trattament ta ’ Rapilysin jistgħu jiżdiedu jekk inti għandek xi waħda minn dawn il - kondizzjonijiet li ġejjin:
• systolic blood pressure higher than 160 mmHg
• pressjoni tad- demm sistolika ogħla iktar minn 160 mmHg
• bleeding in the gastrointestinal, urinary or genital tract within the past 10 days
• ħruġ tad- demm gastrointestinali, urinarju jew fl- apparat ġenitali fl- aħħar 10 t’ ijiem
• high likelihood of a blood clot in the heart (e. g. as a result of narrowing of a heart valve or atrial fibrillation)
• probabbiltà għolja ta ’ embolu fil- qalb (eż. li jirriżulta minn tidjiq ta ’ xi valv tal- qalb jew fibrilazzjoni atrijali)
• septic inflammation of a vein with blood clotting (septic thrombophlebitis) or blocked blood vessels at an infected site
• infjammazzjoni settika ta ’ xi vina flimkien ma ’ embolu (tromboflebite settika) jew vini u arterji imblukkati f’ xi parti infettata
• age over 75 years
• età ta ’ aktar minn 75 sena
• any other condition in which bleeding might be especially dangerous or might occur at a site where it would be difficult to control
• xi kondizzjoni oħra fejn il- ħruġ tad- demm jista ’ jkun partikularment perikoluż jew li jista ’ jseħħ f’ parti fejn ikun diffiċli biex tikkontrollah
At present, little data are available on the use of Rapilysin in patients with diastolic blood pressure higher than 100 mmHg
Bħalissa, ftit informazzjoni hija disponibbli dwar l- użu ta ’ Rapilysin f’ pazjenti bi pressjoni tad- demm dijastolika ogħla aktar minn 100 mmHg
Abnormal heart beats (arrhythmias)
Taħbit tal- qalb anormali (arritmiji)
Thrombolytic treatment may cause the heart to beat irregularly.
It- trattament trombolitiku jista ’ jikkawża lill- qalb biex tħabbat irregolarment.
Therefore tell the medical staff immediately if you
Għalhekk għid lill - istaff mediku minnufih jekk inti
• feel palpitations or an irregular heart beat
• tħoss palpitazzjonijiet jew taħbit tal- qalb irregolari
Repeated use
22 Użu ripetut
At present there is no experience with repeated use of Rapilysin.
Bħalissa m’ hemm l- ebda esperjenza dwar l- użu ripetut ta ’ Rapilysin.
Therefore, repeated use is not recommended.
Għalhekk, l- użu ripetut mhuwiex irrakkommandat.
Antibody formation to the reteplase molecule has not been seen.
Il- formazzjoni ta ’ l- anti- korpi għall- molekula ta ’ reteplase ma ġietx osservata.
Use in children
Użu fit- tfal
Safety and effectiveness of Rapilysin in children have not been established.
Is- sigurtà u l- effikaċja ta ’ Rapilysin fit- tfal għandha ma ġietx stabbilita.
Treatment of children with Rapilysin is not recommended.
It- trattament b’ Rapilysin fit - tfal mhuwiex irrakkommandat.
21 Using other medicines:
Meta tuża mediċini oħra:
Heparin and other medicines that thin the blood (anticoagulants) and acetylsalicylic acid (a substance used in many medicines used to relieve pain and lower fever) may increase the risk of bleeding.
Heparin u mediċini oħra li jraqqu d- demm (mediċina kontra t- tagħqid tad- demm) u acetylsalicylic acid (sustanza wżata f’ ħafna mediċini biex ittaffi l- uġigħ u tbaxxi d- deni) jistgħu jżidu ir- riskju ta ’ fsada.
For information on medicines that should not be physically mixed with Rapilysin solution for injection see section 3.
Għall- tagħrif dwar mediċini oħra li m’ għandhomx ikunu fiżikament imħallta ma ’ Rapilysin soluzzjoni għall- injezzjoni ara sezzjoni 3.
Pregnancy
It- tqala
There is no experience with Rapilysin in pregnant women.
M’ hemm l- ebda esperjenza ta ’ Rapilysin f’ nisa tqal.
Therefore it should not be used except in life-threatening situations.
Għalhekk dan m’ għandux jintuża ħlief f’ sitwazzjonijiet ta ’ periklu għall- ħajja.
You must tell your doctor if you are pregnant or think you are pregnant.
Għandek tgħid lit- tabib tiegħek jekk inti tqila jew jekk taħseb li inti tqila.
Your doctor can tell you the risks and benefits of using Rapilysin during pregnancy.
It- tabib tiegħek jista ’ jgħidlek dwar ir- riskji u l- ġid bl- użu ta ’ Rapilysin waqt it- tqala.
You should not breast-feed your baby during treatment with Rapilysin as it is not known whether Rapilysin is excreted into mother’ s milk.
M’ għandekx tredda ’ lit- tarbija tiegħek waqt it- trattament b’ Rapilysin għax mhuwiex magħruf jekk Rapilysin huwiex imneħħi mal- ħalib ta ’ l- omm.
Mother’ s milk should be thrown away during the first 24 hours after thrombolytic treatment.
Il- ħalib ta ’ l- omm għandu jintrema fl- ewwel 24 siegħa wara t- trattament trombolitiku.
Discuss with your doctor when you can take up breast-feeding again.
Iddiskuti mat- tabib tiegħek dwar meta inti tkun tista ’ terġa ’ tibda t - treddigħ mill- ġdid.
HOW TO USE RAPILYSIN
KIF GĦANDEK TUŻA RAPILYSIN
Rapilysin is usually given in a hospital.
Rapilysin is- soltu huwa mogħti fi sptar.
The medicine is supplied in vials as a powder for injection.
Il- mediċina hija pprovduta f’ kunjetti bħala trab għall - injezzjoni.
Before use, the powder for injection must be dissolved in the water for injection supplied in the prefilled syringe that is in the package.
Qabel l- użu, it- trab għall- injezzjoni għandu jiġi maħlul fl- ilma għall- injezzjoni pprovdut fis- siringa mimlija għal lest li hemm fil- pakkett.
Do not add any other medicines.
Iżżid l- ebda mediċini oħra.
The resulting solution must be used immediately.
Is- soluzzjoni li tirriżulta trid tintuża minnufih.
The solution must be examined to ensure that only clear, colourless solution is injected.
Is- soluzzjoni għandha tkun eżaminata biex ikun assigurat li soluzzjoni ċara u bla kulur biss tkun injettata.
If the solution is not clear and colourless it should be thrown away.
Jekk is- soluzzjoni ma tkunx ċara u bla kulur, din għandha tintrema.
Treatment with Rapilysin 10 U should be started as soon as possible after the symptoms of heart attack begin.
It- trattament b’ Rapilysin 10 U għandu jiġi mibdi kemm jista ’ jkun malajr wara li s- sintomi ta ’ attakk tal- qalb jibdew.
Heparin and Rapilysin cannot be mixed in the same solution.
Heparin u Rapilysin ma jistgħux jitħalltu fl- istess soluzzjoni.
Other medicines may also not mix well with Rapilysin.
Mediċini oħra jistgħu wkoll ma jitħalltux sewwa ma ’ Rapilysin.
No other medicines should be added to the injection solution (see below).
L- ebda mediċina oħra m’ għandha tiġi miżjuda mas- soluzzjoni għall - injezzjoni (ara taħt).
Rapilysin should be injected preferably through an intravenous line that is used only for the injection of Rapilysin.
Rapilysin għandu jiġi injettat preferibilment minn pajp għal ġol- vini li jkun użat biss għall- injezzjoni ta ’ Rapilysin.
No other medicines should be injected through the line reserved for Rapilysin, either at the same time, or before or after Rapilysin injection.
L- ebda mediċina oħra m’ għandha tiġi injettata mill- pajp riservat għal Rapilysin, la fl- istess ħin, lanqas qabel u lanqas wara l- injezzjoni ta ’ Rapilysin.
This applies to all medicines including heparin and acetylsalicylic acid, which are given before and after Rapilysin to reduce the risk of new blood clots forming.
Dan japplika għall- mediċini kollha, inkluża Eparina u acetylsalicylic acid, li jkunu mogħtija qabel u wara Rapilysin biex inaqqsu r- riskju ta ’ formazzjoni ta ’ emboli ġodda.
If the same line has to be used, this line (including Y-line) must be flushed thoroughly with a 0.9% sodium chloride or 5% dextrose solution before and after the Rapilysin injection.
Jekk l- istess pajp irid jiġi użat, dan il- pajp (inkluż il- Y- pajp) għandu jiġi mlaħlaħ bl- akbar reqqa b ’ 0. 9% soluzzjoni ta ’ sodium chloride jew 5% soluzzjoni ta ’ dextrose, qabel u wara l- injezzjoni ta ’ Rapilysin.
Dosage of Rapilysin
23 Dożaġġ ta ’ Rapilysin
Rapilysin is given as a 10 U injection followed by a second 10 U injection 30 minutes later (double bolus).
Rapilysin huwa amministrat bħala injezzjoni ta ’ l- 10 U segwita mit- tieni injezzjoni ta ’ l- 10 U 30 minuta wara (injezzjoni doppja).
Each injection should be given slowly within 2 minutes.
Kull injezzjoni hija mogħtija bil- mod ġol- vini f’ temp ta ’ 2 minuti.
The injection must not be given mistakenly outside the vein.
Assigura li l- injezzjoni ma tingħatax bi żball barra mill- vina.
Therefore, be sure to tell the medical staff if you experience pain during the injection.
Għalhekk, tkun ċert/ a li tgħid lill- istaff mediku jekk inti tħoss xi uġigħ waqt l- injezzjoni.
Heparin and acetylsalicylic acid are given before and after Rapilysin to reduce the risk of new blood clots forming.
Heparin u acetylsalicylic acid huma mogħtija qabel u wara Rapilysin biex inaqqsu ir- riskju ta ’ formazzjoni ta ’ emboli ġodda.
22 Dosage of Heparin
Dożaġġ ta ’ Heparin
The recommended dose of heparin is 5000 I. U. given as a single injection before Rapilysin, followed by an infusion of 1000 I. U. per hour starting after the second Rapilysin injection.
Id- doża rrakkommandata ta ’ heparin hija ta ’ 5000 I. U. mogħtija bħala injezzjoni waħedha qabel Rapilysin, segwita minn infużjoni ta ’ 1000 I. U. kull siegħa li tibda wara t- tieni injezzjoni ta ’ Rapilysin.
Heparin should be given for at least 24 hours, preferably for 48 - 72 hours, in order to keep aPTT values 1.5 to 2 times normal.
Heparin għandha tkun mogħtija għal mill- inqas 24 siegħa, preferibbilment għal 48 - 72 siegħa, sabiex iżżomm il- valuri ta ’ l- aPTT minn 1. 5 sa 2 dawk normali.
Dosage of Acetylsalicylic Acid
Dożaġġ ta ’ Acetylsalicylic acid
The dose of acetylsalicylic acid given before Rapilysin should be at least 250 mg – 350 mg and should be followed by 75 – 150 mg/ day, at least until discharge from hospital.
Id- doża ta ’ acetylsalicylic acid mogħti qabel Rapilysin għandha tkun ta ’ mill- inqas 250 mg – 350 mg segwita minn ta ’ mill- inqas 75 – 150 mg/ kuljum sa meta l- pazjent joħroġ mill- isptar.
Therefore, the compatibility of the glass syringe and intravenous access should be ensured before use.
Istruzzjonijiet għall- użu/ immaniġġjar
Remove the protective flip-cap from the vial of Rapilysin 10 U and clean the rubber closure with an alcohol wipe.
Neħħi l- għatu protettiv mill- kunjett ta ’ Rapilysin 10 U u naddaf l- għeluq tal- lastku b’ xi ħaġa li timsaħ mxarrba bl- alkoħol.
Open the package containing the reconstitution spike, remove both protective caps from the reconstitution spike.
Iftaħ il- pakkett li fih l- spike ’ għar- rikostituzzjoni, neħħi ż- żewġ għatjien protettivi minn ġo l - ispike għar- rikostituzzjoni.
Insert the spike through the rubber closure into the vial of Rapilysin 10 U.
Daħħal l- ispike (għatu tal- plastik li jiksi il- kunjett ta ’ Rapilysin) minn ġo l- għeluq tal- lastku fil - kunjett ta ’ Rapilysin 10 U.
Connect the syringe to the reconstitution spike and transfer the 10 ml of solvent into the vial of Rapilysin 10 U.
Ikkonnettja s - siringa ma ’ l - ‘ spike ’ għar- rikostituzzjoni u ittrasferixxi l- 10 ml tas- solvent fil- kunjett ta ’ Rapilysin 10 U.
DO NOT SHAKE.
Daħħal l- ispike (għatu tal- plastik li jiksi il- kunjett ta ’ Rapilysin) minn ġo l- għeluq tal- lastku fil - kunjett ta ’ Rapilysin 10 U.
Withdraw 10 ml of Rapilysin 10 U solution back into the syringe.
Iġbed 10 ml ta ’ soluzzjoni ta ’ Rapilysin 10 U lura ġos- siringa.
A small amount of solution may remain in the vial due to overfill.
Ammont żgħir tas- soluzzjoni jista ’ jibqa ’ fil- kunjett minħabba t- tifwir.
8.
24 10.
Disconnect the syringe from the reconstitution spike.
Skonnetta s- siringa minn ma ’ l- ispike għar- rikostituzzjoni u waħħal il- labra sterilizzata pprovduta.
The dose is now ready for intravenous administration.
Id- doża issa hija lesta għall- għoti ġol- vini.
No other medicines should be injected through the line reserved for Rapilysin either at the same time, or prior to, or following Rapilysin injection.
L- ebda mediċina m’ għandha tiġi njettata minn ġol- pajp riservat għal Rapilysin, la fl- istess ħin, la qabel, u lanqas wara l- injezzjoni ta ’ Rapilysin.
This applies to all products including heparin and acetylsalicylic acid, which should be administered before and following the administration of reteplase to reduce the risk of re-thrombosis.
Dan japplika għall- prodotti kollha inkluż heparin, u acetylsalicylic acid, li għandhom jingħataw qabel u wara l- għotja ta ’ reteplase biex inaqqsu r- riskju ta ’ trombożi mill- ġdid.
In those patients where the same line has to be used, this line (including Y-line) must be flushed thoroughly with a 0.9% sodium chloride or 5% dextrose solution prior to and following the Rapilysin injection.
F’ dawk il- pazjenti fejn l- istess pajp għandu jintuża, dan il- pajp (inkluż il- pajp- Y), għandu jiġi mlaħlaħ sew b’ soluzzjoni ta ’ 0. 9% sodium chloride jew 5% dextrose qabel u wara injezzjoni ta ’ Rapilysin.
If more Rapilysin is used than recommended:
Jekk tuża Rapilysin aktar milli suppost:
In the event of overdosage there may be an increased risk of bleeding.
F’ każ ta ’ doża eċċessiva jista ’ jkun hemm riskju ogħla ta ’ ħruġ tad- demm.
Like all medicines, Rapilysin can cause side effects, although not everybody gets them.
Bħall- mediċini kollha, Rapilysin jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
The most common side effects of Rapilysin which may affect more than 10% of the treated patients: • Bleeding at the injection site, e. g. blood blister (haematoma) • Chest Pain / angina, low blood pressure and heart failure / shortness of breath may reappear • Burning sensation when Rapilysin is injected
L- aktar effetti sekondarji komuni ta ’ Rapilysin li jistgħu jaffettwaw aktar minn 10% tal- pazjenti kkurati: • Fsada fil- post ta ’ l- injezzjoni, e. ż. nuffata bid- demm (ematoma) • Jista ’ jerġa ’ jkun hemm uġigħ fis- sider / anġina, pressjoni tad- demm baxxa u insuffiċjenza tal - qalb / qtugħ ta ’ nifs • Sensazzjoni ta ’ ħruq meta jiġi njettat Rapilysin
Common side effects occurring in 1 to 10% of the treated patients are:
Effetti sekondarji komuni li seħħew f’ 1 sa 10% tal- pazjenti kkurati huma:
• Bleeding in the digestive tract (e. g. bloody or black vomit, or stools) in the gums or in the urinary or genital tract • Abnormal heart beats (arrhythmias), cardiac arrest, circulatory collapse or another heart attack may occur
• Fsada fl- apparat diġestiv (e. ż. rimettar jew purgar bid- demm jew iswed), fil- ħanek jew fl - apparat urinarju jew ġenitali • Taħbit ta ’ qalb anormali (arritmija), il- qalb tieqaf taħdem, kollass ċirkolatorju jew attakk ieħor tal- qalb jista ’ jseħħ
Uncommon side effects occurring in 0,1 to 1% of the treated patients are: • Bleeding around the heart, in the abdomen, the brain or the eyes, under the skin, from the nose or as coughed up blood • Damage to the heart or heart valves, or a blood clot in the lung, brain or other part of body may occur • hypersensitivity (e. g. allergic reactions)
Effetti sekondarji mhux komuni li seħħew f’ 0. 1 sa 1% tal- pazjenti kkurati huma: • Fsada madwar il- qalb, fl- addome, il- moħħ jew l- għajnejn, taħt il- ġilda, mill- imnieħer jew tisgħol u ttella ’ d- demm • Ħsara lill- qalb jew lill- valvoli tal- qalb, jew biċċa ta ’ demm magħqud fil- pulmun, moħħ jew parti oħra tal- ġisem tista ’ sseħħ • Sensittività eċċessiva (e. ż. reazzjonijiet allerġiċi)
Other less common side effects occurring in less than 0.01% of the treated patients are: • Events related to the nervous system (e. g. epileptic seizure, convulsion, speech disorder, delirium, agitation, confusion, depression, psychosis) • severe allergic reaction, causing shock or collapse
• Episodji relatati mas- sistema nervuża (e. ż. attack epilettiku, konvulżjoni, disturbi fil- kelma, delirju, aġitazzjoni, konfużjoni, depressjoni, psikosi) • reazzjoni allerġika severa, li twassal għal xokk jew kollass
Cardiovascular events can be life-threatening or cause death.
Episodji kardjovaskulari jistgħu jkunu ta ’ periklu għall- ħajja jew jikkawżaw il- mewt.
Patients with systolic blood pressure over 160 mmHg have a greater risk of bleeding in the brain.
Pazjenti bi pressjoni tad- demm sistolika ta ’ aktar minn 160 mmHg għandhom riskju ikbar ta ’ ħruġ tad - demm fil- moħħ.
The risk of intracranial bleeding and fatal intracranial bleeding increases with increasing age.
Ir- riskju ta ’ ħruġ tad- demm fatali fil- kranju u ħruġ tad- demm fil- kranju iżid ma ’ l- età.
Death or permanent disability are not uncommon in patients who have a stroke (including bleeding in the brain) or other serious bleeding problem.
Il- mewt jew id- diżabilità permanenti jistgħu iseħħu f’ pazjenti li jkollhom puplesija (inkluż ħruġ tad- demm fil- moħħ) jew problema oħra serji ta ’ ħruġ tad- demm.
Be sure to tell hospital staff immediately if any of these symptoms appear.
25 Kun żgur li tgħid minnufih lill- ħaddiema ta ’ l- isptar jekk jitfaċċa xi wieħed minn dawn is- sintomi.
HOW TO STORE RAPILYSIN
KIF TAĦŻEN RAPILYSIN
• Keep out of the reach and sight of children.
• Żomm fejn ma ’ jintlaħaqx u ma jidhirx mit- tfal.
• Do not use Rapilysin after the expiry date stated on the carton and on the label of the vial.
• Tużax Rapilysin wara d- data ta ’ skadenza li tidher fuq il- kaxxa u fuq it- tikketta tal- kunjett.
• Do not store above 25 °C.
• Taħżinx f’ temperatura ’ l fuq minn 25 °C.
• Keep the vial in the outer carton in order to protect from light.
• Żomm il- kunjett fil- kartuna ta ’ barra sabiex tilqa ’ mid- dawl.
• After reconstitution (“ when dissolved”), the solution must be used immediately.
• Wara r- rikostituzzjoni (“ meta jinħall ”), is- soluzzjoni għandha tintuża minnufih.
What Rapilysin contains:
X’ fih Rapilysin:
- The active substance of Rapilysin is reteplase 10U/ 10ml after reconstitution.
- Is- sustanza attiva ta ’ Rapilysin hija reteplase 10U/ 10ml wara r- rikostituzzjoni.
- The other ingredients in the vials are:
- Is- sustanzi l- oħra fil- kunjetti huma:
Tranexamic acid di-potassium-hydrogen phosphate phosphoric acid sucrose polysorbate 80
Tranexamic acid di- potassium- hydrogen phosphate phosphoric acid sucrose polysorbate 80
10 ml Water for injection (prefilled syringe)
10 ml ilma għall- injezzjoni (siringa mimlija għal lest)
What Rapilysin looks like and content of the pack
Id- Dehra tal- prodott u l- kontenuti tal- pakkett:
Rapilysin is presented as a powder and a solvent for injection (0.56 g powder in a vial and 10 ml solvent in a pre-filled syringe with a reconstitution spike and a needle-pack of 2)
Rapilysin huwa fornut bħala trab u solvent għall- injezzjoni (0. 56 g trab f’ kunjett u 10 ml ta ’ solvent f’ siringa mimlija għal lest bi spike għar- rikostituzzjoni u pakkett tal- labar li fih 2)
Marketing authorisation holder
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq
Manufacturer
Isem u indirizz tal- manifattur
25 For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq.
België/ Belgique/ Belgien ALL-in-1 bvba Tél/ Tel: +32 (0) 32 86 88 88
26 België/ Belgique/ Belgien ALL- in- 1 bvba Tél/ Tel: +32 (0) 32 86 88 88
Kύπρος A.
27 Kύπρος A.
What is Raptiva?
X’ inhi Raptiva?
Raptiva is a powder and solvent that are made up into a solution for injection.
Raptiva hija trab u solvent li titħallat f’ soluzzjoni għall- injezzjoni.
It contains the active substance efalizumab (100 mg/ ml).
Hija fiha s- sustanza attiva efalizumab (100 mg/ ml).
What is Raptiva used for?
Għal xiex tintuża Raptiva?
Raptiva is used for the treatment of adults with moderate to severe chronic (long-term) plaque psoriasis (a disease causing red, scaly patches on the skin).
Raptiva tintuża fil- kura ta ’ adulti bi psorjasi tal- plakek (marda li tikkaġuna rqajja ’ ħomor bil- qxur fuq il- ġilda).
It is used in patients who have failed to respond to or cannot take other systemic (whole-body) treatments for psoriasis, including ciclosporin, methotrexate and PUVA (psoralen ultraviolet-A).
Hija tintuża f’ pazjenti li naqsu milli jirrispondu jew li ma jistgħux jieħdu trattamenti sistemiċi (għall- ġisem kollu) oħra għall- psorjasi, inklużi ciclosporin, methotrexate u PUVA (psoralen ultraviolet- A).
PUVA is a type of treatment where the patient receives a medicine containing a compound called a ‘ psoralen ’ before being exposed to ultraviolet light.
PUVA huwa tip ta ’ trattament fejn il- pazjent jirċievi mediċina li fiha taħlita msejħa ‘ psoralen ’ qabel ma jkun espost għal dawl ultravjola.
How is Raptiva used?
Kif tintuża Raptiva?
Raptiva treatment should be initiated by a doctor who specialises in dermatology (the treatment of skin conditions).
Il- kura b’ Raptiva għandha tinbeda minn tabib li jispeċjalizza fid- dermatoloġija (il- kura ta ’ kondizzjonijiet tal- ġilda).
It is given as a 12-week course, with a first dose of 0.7 mg per kilogram body weight followed by weekly injections of 1.0 mg/ kg.
Hija tingħata bħala kors ta ’ 12- il ġimgħa, bl- ewwel doża ta ’ 0. 7 mg għal kull kilogramm ta piż korporali segwita minn injezzjonijiet ta ’ kull ġimgħa ta ’ 1. 0 mg/ kg.
Raptiva is given by injection under the skin.
Raptiva tingħata b’ injezzjoni taħt il- ġilda.
The maximum single dose is 200 mg.
Doża waħda massima hija 200 mg.
Therapy should only be continued in patients who have responded to treatment.
It- terapija għandha titkompla biss f’ pazjenti li rrispondew għal kura.
Patients may inject themselves once they have been trained, if their doctor thinks that this is appropriate.
Il- pazjenti, ġa la darba jiġu mħarrġa, jistgħu jinjettaw lilhom infushom, jekk it- tabib tagħhom jaħseb li dan huwa addattat.
Raptiva should be used with caution in patients who have problems with their liver or kidneys.
Raptiva għandha tintuża bil- kawtela f’ pazjenti li għandhom problemi bil- fwied u l- kliewi tagħhom.
How does Raptiva work?
Kif taħdem Raptiva?
The active substance in Raptiva, efalizumab, is a monoclonal antibody.
Is- sustanza attiva f’ Raptiva, efalizumab, hija antikorp monoklonali.
A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and bind to a specific structure (called an antigen) that is found on the surface of cells in the body.
Antikorp monoklonali huwa antikorp (tip ta ’ proteina) li ġie mfassal biex jagħraf u jorbot ma ’ struttura speċifika (imsejħa antiġen) li tinsab fuq il- wiċċ ta ’ ċelloli fil- ġisem.
Efalizumab has been designed to bind to part of a protein called LFA-1 on the surface of lymphocytes, a type of white blood cell that is involved in the inflammation process.
Efalizumab ġie mfassal biex jorbot ma ’ parti ta ’ proteina msejħa LFA- 1 fuq il- wiċċ tal- limfoċiti, tip ta ’ ċellola bajda tad- demm li hija involuta fil- proċess ta ’ l - infjammazzjoni.
This improves the symptoms of the disease.
Peress li LFA- 1 hija importanti sabiex tgħin il- limfoċiti jeħlu maċ- ċelloli fil- ġilda, efalizumab inaqqas l- infjammazzjoni li tikkaġuna psorjasi fil- ġilda.
7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Fil- ħames studju, 526 mis- 793 pazjent kienu ‘ ta ’ bżonn għoli ’, 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Raptiva has been studied in five main studies involving over 3,000 patients with moderate to severe plaque psoriasis.
(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 peress li naqsu milli jirrispondu għal jew ma setgħux jieħdu kuri sistemiċi oħra.
In all studies, the effectiveness of Raptiva was compared with that of placebo (a dummy treatment).
Fl- istudji kollha, l - effettività ta ’ Raptiva kienet imqabbla ma ’ dik ta ’ plaċebo (kura finta).
The main measure of effectiveness was the proportion of patients who ‘ responded ’ to treatment after 12 weeks, meaning that symptom scores improved by 75% or more.
Il- miżura ewlenija ta ’ l - effettività kienet il- proporzjon ta ’ pazjenti li ‘ irrispondew ’ għal kura wara 12- il ġimgħa, li tfisser li l - iskors tas- sintomi tjiebu b’ 75% jew aktar.
What benefit has Raptiva shown during the studies?
X’ benefiċċju uriet Raptiva waqt l- istudji?
Raptiva was more effective than placebo at improving the symptoms of psoriasis.
Raptiva kienet aktar effettiva minn plaċebo biex ittejjeb is- sintomi ta ’ psorjasi.
Looking at the results of the first four studies taken together, 320 (26%) of the 1,213 patients receiving 1.0 mg/ kg Raptiva per week responded to treatment, compared with 25 (4%) of the 715 receiving placebo.
F’ ħarsa lejn ir- riżultati ta ’ l- ewwel erba ’ studji meħudin flimkien, 320 (26%) mill- 1, 213- il pazjent li kienu qed jirċievu 1. 0 mg/ kg Raptiva kull ġimgħa irrispondew għal kura, meta mqabbla ma ’ 25 (4%) tas- 715 li kienu qed jirċievu plaċebo.
The results were similar in those who had and those who had not taken systemic treatments for psoriasis before.
Ir- riżultati kienu simili f’ dawk li ħadu u dawk li ma kinux ħadu qabel kuri sistemiċi għal psorjasi.
In the fifth study, overall, 166 (31%) of the 529 patients receiving Raptiva responded to treatment, compared with 11 (4%) of the 264 receiving placebo.
Bħala total, fil- ħames studju, 166 (31%) mill- 529- il pazjent li kienu qed jirċievu Raptiva irrispondew għal kura, meta mqabbla ma ’ 11 (4%) tal- 264 li kienu qed jirċievu plaċebo.
Looking only at the ‘ high need’ patients in this study, 30% of those receiving Raptiva responded to treatment, compared with 3% of those receiving placebo.
F’ ħarsa lejn il- pazjenti bi ‘ ħtiġijiet għoljin ’ biss, 30% ta ’ dawk li kienu qed jirċievu Raptiva irrispondew għal kura, imqabbla ma ’ 3% ta ’ dawk li kienu qed jirċievu plaċebo.
What is the risk associated with Raptiva?
X’ inhu r- riskju assoċjat ma ’ Raptiva?
The most common side effects with Raptiva (seen in more than 1 patient in 10) are mild to moderate flu-like symptoms including headache, fever, chills, nausea (feeling sick), myalgia (muscle pain), and leucocytosis and lymphocytosis (increased white blood cell counts).
L- aktar effetti sekondarji komuni b’ Raptiva (dehru f’ aktar minn pazjent 1 f’ kull 10) huma sintomi ta ’ influwenza ħfief għal moderati inklużi uġigħ ta ’ ras, deni, tertir, nawżja (dardir), majalġja (uġigħ fil - muskoli), u lewkoċitożi u limfoċitożi (żieda fl- għadd taċ- ċelloli bojod tad- demm).
For the full list of all side effects reported with Raptiva, see the Package Leaflet.
Għal- lista sħiħa ta ’ l- effetti sekondarji kollha irrapportati b’ Raptiva, ara l- Fuljett ta ’ Tagħrif.
Raptiva should not be used in people who may be hypersensitive (allergic) to efalizumab or any of the other ingredients.
Raptiva m’ għandhiex tintuża f’ nies li jistgħu jkunu sensittivi żżejjed (allerġiċi) għal efalizumab jew għal kwalunkwe sustanzi oħra tiegħu.
It should also not be used in patients who have had cancer, who have active tuberculosis or another severe infection, who have other types of psoriasis, or who have low levels of immunity.
M’ għandhiex tintuża ukoll f’ pazjenti li kellhom il- kanċer, li għandhom tuberkulożi attiva jew xi infezzjoni severa oħra, li kellhom tipi oħra ta ’ psorjasi, jew li għandhom livelli baxxi ta ’ immunità.
Why has Raptiva been approved?
Għaliex ġiet approvata Raptiva?
The Committee for Medicinal products for Human Use (CHMP) noted that psoriasis was more severe in ‘ high-need’ patients, and that the effectiveness of Raptiva is relevant for these patients.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) innota li l- psorjasi kienet aktar severa f’ pazjenti bi ‘ ħtiġijiet għolja ’, u li l- effettività ta ’ Raptiva hija relevanti għal dawn il- pazjenti.
Therefore, the Committee decided that Raptiva’ s benefits are greater than its risks for the treatment of adult patients with moderate to severe chronic plaque psoriasis who have failed to respond to, or who have a contra-indication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate and PUVA.
Għaldaqstant, il- Kumitat iddeċieda li l- benefiċċji ta ’ Raptiva huma akbar mir- riskji tagħha għal kura ta ’ pazjenti adulti bi psorjasi tal- plakek kronika, severa jew moderata li naqsu milli jirrispondu għal, jew li għandhom kontra- indikazzjoni għal, jew li mhumiex tolleranti għal terapiji sistemiċi oħra inklużi ciclosporin, methotrexate u PUVA.
The Committee recommended that Raptiva be given marketing authorisation.
Il- Kumitat irrikmanda li Raptiva tingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Raptiva:
Tagħrif ieħor dwar Raptiva:
The European Commission granted a marketing authorisation valid throughout the European Union for Raptiva to Serono Europe Ltd. on 20 September 2004.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq għal Raptiva valida għall- Unjoni Ewropea kollha lil Serono Europe Ltd. fl- 20 ta ’ Settembru 2004.
The full EPAR for Raptiva can be found here.
L- EPAR sħiħ għal Raptiva huwa disponibbli minn hawn.
Package size
Daqs tal- pakkett 1 kunjett + 1 siringa mimlija għal- lest
Powder: vial (glass); solvent: prefilled syringe (glass)
Trab: kunjett (tal- ħġieġ); solvent:
1 vial + 1 pre-filled syringe + 2 needles
4 kunjett + 4 siringi mimlijien lesti +
Powder: vial (glass); solvent: pre- filled syringe (glass)
Trab: kunjett (tal- ħġieġ); solvent:
4 vials + 4 pre-filled syringes + 8 needles
12 kunjett + 12 siringi mimlijien lesti
12 vials + 12 pre-filled syringes + 24 needles
+ 24 labar
Raptiva 100 mg/ ml powder and solvent for solution for injection
Raptiva 100 mg/ ml trab u solvent għal soluzzjoni għall- injezzjoni.
Each vial contains a retrievable amount of 125 mg of efalizumab.
Fjala waħda fiha ammont li jista ’ jitneħħa ta ’ 125mg ta ’ efalizumab.
Reconstitution with the solvent yields a solution containing efalizumab at 100 mg/ ml.
Rikosstituzzjoni ma ’ is- solvent jagħti soluzzjoni ta ’ 100mg/ ml ta ’ efalizumab.
Efalizumab is a recombinant humanized monoclonal antibody produced in genetically engineered Chinese Hamster Ovary (CHO) cells.
Efalizumab huwa monoclonal antikorpu umanizzat rikombinat li jiġi magħmul fiċ- ċelloli ta ’ l- ovarji tal- ħamster Ċiniż (CHO) li għandhom materjal ġenetiku mibdul.
Efalizumab is an IgG1 kappa immunoglobulin, containing human constant region sequences and murine light- and heavy-chain complementary determining region sequences.
Efalizumab huwa IgG1 kappa immunoglobulina, bi sekwenzi kostanti uman u sekwenzi komplimentari ta ’ katini ħfif u tqal, murini.
2.5 mg polysorbate 20, 3.55 mg histidine, 5.70 mg histidine hydrochloride monohydrate, 102.7 mg sucrose.
2. 5 mg polysorbat 20, 3. 55 mg histidine, 5. 70 mg histidine hydrochloride monohydrate, 102. 7 mg sukrożju.
The powder is a white to off white cake.
It- trab huwa abjad – offwajt.
The solvent is a clear, colourless liquid.
Is- solvent huwa likwidu car, mingħajr kulur
The pH of the reconstituted solution is 5.9 – 6.5.
Il - pH tas- soluzzjoni rrikostitut huwa 5. 9 – 6. 5.
Treatment of adult patients with moderate to severe chronic plaque psoriasis who have failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate and PUVA (see section 5.1 – Clinical Efficacy).
Kura ta ’ pazjienti adulti bi psorajiżi kronika plaque, li hija moderata jew severa, li fallew li jirrispondu għal, jew għandhom xi kontraindikazzjoni għal, jew huma intolerranti għal kuri sistemiċi oħrajn inkluż ciclosporin, methotrexate u PUVA (ara sezzjoni 5. 1 – Effikaċja Klinika).
Treatment with Raptiva should be initiated by a physician specialised in dermatology.
Il- kura permezz ta ’ Raptiva għandha tinbeda taħt is- superviżjoni ta ’ tabib b’ esperjenza fil- kura ta ’ problemi tal- ġilda.
An initial single dose of 0.7 mg/ kg body weight is given followed by weekly injections of 1.0 mg/ kg body weight (maximum single dose should not exceed a total of 200 mg).
Jingħata doża waħda inizjali ta ’ 0. 7mg/ kg piż tal- ġisem, issegwit min injuzzjoni kull ġimgħa ta ’ 1. 0mg/ kg piż tal- ġisem (doża waħda singolari ma tridx tkun iżjed minn 200mg).
The volume to be injected should be calculated as follows:
Il – volum li jrid jingħata huwa ikkalkulat kif jidher taħt:
Volume to be injected per 10 kg body weight
Volum
Single initial
li jrid jingħata / 10kg piż tal- ġisem
dose:
Doża waħda inizjali:
0.7 mg/ kg
0. 7 mg/ kg Dożi segwenti:
The duration of therapy is 12 weeks.
Il- kura jrid jingħata għal 12- il ġimgħa.
Therapy may be continued only in patients who responded to treatment (PGA good or better).
Il- kura jista jkun kontinwat biss f’ dawk il- pazjienti li jrispondew għal trattament (PGA tajjeb jew aħar).
For discontinuation guidance see section 4.4.
Għal għajnuna biex titwaqqaf il- kura, ara sezzjoni 4. 4.
2 Children and adolescents (< 18 years) Raptiva is not recommended for use in children below age 18 due to a lack of data on safety and efficacy.
2 Tfal u adolexxenti (< 18 years) Raptiva mhuwiex irrakkomandat għal l- uzu fi tfal taħt 18- il sena, peress li m’ hemx informazzjoni dwar is- sigurta u l- effikaċja.
Use in the elderly (≥ 65 years) The dosage and administration schedule in the elderly should be the same as for adults (see also section 4.4).
(ara sezzjoni 4. 4).
Patients with renal or hepatic impairment No studies have been conducted in patients with renal or hepatic impairment.
Pazjienti b’ indeboliment tal- kliewi jew tal - fwied Ma sarux studji f’ pazjienti b’ indeboliment tal- kliewi jew tal– fwied.
Raptiva should be used with caution in this patient population.
Raptiva jrid jintuża b’ attenzjoni f’ dawn il- pazjienti.
Method of administration Raptiva is for subcutaneous injection.
Mod ta ’ kif jingħata Raptiva huwa għall- injezzjoni għal taħt il- ġilda.
Injection sites should be rotated.
Għall- istruzzjoni ara sezzjoni 6. 6.
After proper training in the reconstitution and injection technique, patients may self-inject with Raptiva, if their physician determines that this is appropriate.
Wara li l- pazjienti jigu tgħallmin sew fuq kif il- prodott irid jiġi rrikostitwit u injettatat, huma jistgħu jagħhtuha lilhom infushom, jekk it- tabib tagħhom jaħhseb li dan huwa approvat.
Hypersensitivity to efalizumab or to any of the excipients.
Sensittività eċċessiva għal efalizumab jew għal xi sustanzi mhux attivi.
Patients with history of malignancies.
Pazjienti bi passat ta ’ kankru.
Patients with active tuberculosis and other severe infections.
Pazjienti b ’ tuberkulosi attiva u infezzjonijiet severi oħrajn.
Patients with specific forms of psoriasis like guttate, erythrodermic or pustular psoriasis as sole or predominant form of psoriasis.
Pazjienti b’ formi speċifii ta ’ psorajiżi bħal guttate, erythrodermic jew pustular psorajiżi, bħala l- uniku jew predominanti forma ta ’ psorajiżi.
Patients with immunodeficiencies.
Pazjienti b ’ immunodeffiċenzja.
Effects on the immune system
Effetti fuq is- sistema immuni
a) Infections Raptiva is a selective immunosuppressor that alters T-lymphocyte function and may affect host defences against infections.
a) Infezzjonijiet Raptiva huwa immunosuppressor selettiv li għandu effett fuq il- funzjoni ta ’ T- lymphocytes u għalhekk jista ’ jaffetwa id- defenzi tal- ġisem kontra infezzjonijiet.
JC virus infection.
Għandu l- potenzjal illi jiżdied ir - riskju jew is- severita ’ ta ’ infezzjonijiet, e. g. pnewmonja tuberkulosi, u jerġa jattiva infezzjonijiet kroniċi, infezzjoni b’ JC virus.
Patients developing an infection during treatment with Raptiva should be monitored and according to severity Raptiva should be discontinued.
Pazjienti illi jkollhom xi infezzjoni waqt il- kura b’ Raptiva jridu jkunu monitorjati u skond is- severta ’ Raptiva jrid jiġi mwaqqaf.
In a patient with history of clinically significant recurring infections, Raptiva should be used with caution.
F’ xi pazjent li għandu passat ta ’ infezzjonjiet rikorrenti, li huma klinikamneti sinjifikanti, Raptiva għandu jintuza b’ attenzjoni.
The use of Raptiva may be associated with an increased risk of Progressive Multifocal Leukoencephalopathy (PML).
L- użu ta 'Raptiva jista ’ jiġi assoċjat ma' riskju ta 'Lewkoenkefalopatija Progressiva Multifokali (PML).
One case of JC virus infection resulting in PML has been reported in post-marketing surveillance in a patient with psoriasis receiving Raptiva (see section 4.8).
Każ wieħed ta 'infezzjoni tal- JC virus riżultanti f' PML ġie rrapurtat waqt is- sorveljanza wara t - tpoġġija fis- suq, f' pazjent li jsofri bil- psorijasi u li kien qed jieħu Raptiva (ara sezzjoni 4. 8).
Patients must be monitored at regular intervals for any new or worsening neurological symptoms or signs that may be suggestive of PML (such as impaired cognition, visual disturbances, hemiparesis, altered mental state or behavioural changes).
Pazjenti għandhom jiġu monitorjati f' intervalli regolari għal sintomi ġodda jew sintomi newroloġiċi li jkunu qed jiħżienu jew sinjali li jistgħu jkunu qed jindikaw il- PML (bħal konoxxibilita 'mgħarrqa, disturbi viżwali, ħemipareżi, bdil fl- istat mentali u bidliet komportamentali).
If PML is suspected, further dosing must be suspended until PML has been excluded.
Jekk ikun hemm suspett ta 'PML, it- tkomplija tal- itteħid ta' Raptiva għandha tiġi sospiża sakemm il- PML tigi eskluża.
The clinician should evaluate the patient to determine if the symptoms are indicative of neurological dysfunction, and if so, whether these symptoms are possibly suggestive of PML.
It- tabib għandu jevalwa lill- pazjent sabiex jistabilixxi jekk is- sintomi humiex indikattivi ta 'diżfunzjoni newroloġika, u jekk ikun il- każ, jekk dawn is- sintomi humiex possibilment indikattivi tal- PML.
If any doubt exists, further evaluation, including Magnetic Resonance Imaging (MRI) scan preferably with contrast, cerebrospinal fluid (CSF) testing for JC viral DNA and repeat neurological assessment, should be considered.
Jekk jeżisti xi dubju, aktar evalwazzjoni, inkluża l’ iskan Magnetic Resonance Imaging (MRI) preferibilment bil- kuntrast, provi tal- fluwidu ċerebrospinali (CSF) għad- DNA JC virali u valutazzjoni newroloġika ripetuta, għandhom jiġu kkunsidrati.
If a patient develops PML, the dosing of Raptiva must be permanently discontinued.
Il- pazjenti għandhom ukoll jiġu avżati sabiex jinfurmaw lis- sieħeb jew sieħba tagħhom jew lil min jieħu hsieb il- kura tagħhom, peress li dawn tal- aħħar jistgħu jinnutaw sintomi li ma ’ jkunux magħrufa għall pazjent.
b) Vaccinations Limited data are available on the effects of vaccination.
Jekk il- pazjent jiżviluppa il- PML, l- itteħid ta 'Raptiva għandu jiġi mwaqqaf permanentement.
3 significance of this is unknown.
3 b) Tilqima Hemm inforamzzjoni limitata fuq l- effetti tat- tilqim.
Patients should not receive live and live-attenuated vaccines while on Raptiva therapy.
Pazjienti ma jistgħux jirċievu tilqima li huma live jew live- attenuated waqt il- kura ma ’ Raptiva.
Before vaccination, treatment with Raptiva should be withheld for 8 weeks and can resume 2 weeks after vaccination.
Qabel it- tilqim, kura ma ’ Raptiva jrid jkun imwaqqaf għal 8 ġimgħat u jista ’ jerga ’ jinbeda ġimgħatejn wara t- tilqima.
c) Malignancies and lymphoproliferative disorders It is not yet known whether or not Raptiva can increase the risk of lymphoproliferative disorders or other malignancies in psoriasis patients.
c) Malinni u diżordni limfoproliferattivi Mhuwiex magħruf jekk Raptiva jista ’ jiżdied ir- riskju ta ’ diżordni limfoproliferattivi jew xi malinni oħrajn f’ pazjienti li għandhom il - psorajiżi. Raptiva jrid jitwaqqaf jekk jiżviluppa xi malinn waqt li l - pazjient ikun fuq il- kura.
Raptiva should be discontinued if a malignancy develops while the patient is on treatment (see sections 4.3 and 4.8).
(ara sezzjonijiet 4. 3 u 4. 8).
Raptiva has not been studied in combination with immunosuppressive systemic antipsoriasis medicinal products.
Raptiva ma ġiex studjat ma prodotti mediċinali sistemiċi immunosuppressive kontra l- psorajiżi.
Therefore, combination therapies with these products are not recommended (see section 4.5).
Għallhekk, kuri jkombinnati ma ’ dawn il- prodotti mhumiex irrakomandati.
Immune-mediated haemolytic anaemia In post-marketing surveillance, isolated cases of severe haemolytic anaemia have been reported during treatment with Raptiva.
Immune- mediated haemolytic anaemia Minn sorveljanza li jsir wara li l- prodott jkun fuq is- suq, ġew irraportati kasijiet isolati ta ’ haemolytic anaemia severi waqt kura ma ’ Raptiva.
In such circumstances, Raptiva should be discontinued.
F’ dawn il- kazijiet, raptiva jrid jitwaqqaf.
Thrombocytopenia Thrombocytopenia may occur during Raptiva treatment and may be associated with clinical signs such as echymoses, spontaneous bruising or bleeding from muco-cutaneous tissues.
Thrombocytopenia Thrombocytopenia jista ’ jseħħ waqt kura ma ’ Raptiva u jista ’ jkun assoċjat ma ’ sinjali bħal echymoses, tbenġil spontanju jew titlief tad- demm minn tessut muko - kuutanju.
If these manifestations occur, efalizumab should be stopped immediately, a platelet count should be performed and appropriate symptomatic treatment should be instituted immediately (see section 4.8).
(ara sezzjoni 4. 8)
Platelet counts are recommended upon initiating and periodically while receiving Raptiva treatment.
Huwa rrakomandat illi jsir għodda tal- plejtlits fil- bidu u perjidikament waqt il- kura ma ’ Raptiva.
It is recommended that assessments be more frequent when initiating therapy (e. g., monthly) and may decrease in frequency with continued treatment (e. g., every 3 months).
Huwa rrakomandat li dawn l- ezamijiet ikunu aktar frekwenti fil- bidu tal- kura (e. g., kull xagħar) u jistgħhu jsiru nqas frekwenti fiz- żmien (e. g., kull 3 xagħar).
Inflammatory polyradiculoneuropathy Cases of inflammatory polyradiculoneuropathy have been observed in post-marketing surveillance in patients receiving Raptiva (see section 4.8).
Inflammatory polyradiculoneuropathy Minn sorveljanza li jsir wara li l- prodott jkun fuq is- suq, ġew osservati kasijiet ta’ inflammatory polyradiculoneuropathy f’ pazjienti fuq il - kura ta ’ Raptiva.
Patients have recovered after discontinuation of Raptiva, therefore Raptiva should be stopped following the diagnosis of inflammatory polyradiculoneuropathy.
Wara it- twaqqif ta ’ Raptiva, dawn il- pazjienti rukpraw, għalhekk Raptiva jrid jitwaqqaf wara id- dianjozita ’ inflammatory polyradiculoneuropathy.
Hypersensitivity and allergic reactions As with any recombinant product, Raptiva is potentially immunogenic.
Sensittività eċċessiva u reazzjonijiet allerġiċi Bħal ma kull prodott rikombinat, Raptiva huwa potenzjalment immunogenic.
Consequently, if any serious hypersensitivity or allergic reaction occurs, Raptiva should be discontinued immediately and appropriate therapy initiated (see sections 4.3 and 4.8).
(ara sezzjonijiet 4. 3 u 4. 8).
Arthritis Cases of arthritis have been observed during treatment or after discontinuation of Raptiva.
Artrite Kazijiiet ta ’ artrite ġew osservati waqt il- kura ma ’, jew wara li, jitwaqqaf Raptiva.
It is recommended to discontinue Raptiva if arthritis occurs during treatment.
Huwa rrakomandat li jitwaqqaf Raptiva jekk jkun hemm artrite waqt il- kura.
Psoriasis During treatment with Raptiva, cases of exacerbation of psoriasis, including pustular, erythrodermic, and guttate subtypes, have been observed (see section 4.8).
Psorajiżi Waqt kura ma ’ Raptiva, ka\ ijiet ta ’ psorajiżi li jsir iktar gravi, inkluż it- tipi pustular, erythrodermic u guttate, ġew osservati (ara sezzjoni 4. 8).
In such cases, it is recommended to discontinue treatment with Raptiva.
F’ każijiet bħal dawn, huwa rrakomandat li jitwaqqaf il- kura ma ’ Raptiva.
Discontinuation of treatment may cause a recurrence or exacerbation of plaque psoriasis including erythrodermic and pustular psoriasis, especially in patients not responding to treatment.
Meta jitwaqqaf il- kura, dan jista ’ jikkawża l- psorajiżi biex jerġa ’ joħroġ jew li l- psorjażi plaque isir aktar għar, inkluż erythrodermic u pustular psorjażi, speċjalment f’ pazjienti li mhumiex jirrispondu għal kura.
Gradual reduction of dose or frequency does not appear to be beneficial.
Riduzzjoni gradwali tad- doza jew frekwenza ma jidirx li għandu effett benefiċjali.
Discontinuation Management of patients discontinuing Raptiva includes close observation.
Twaqqif tal- Kura L- immaniġġar tal- pażjienti li jwaqqfu Raptiva tinkludi l- osservazzjoni tagħhom.
In case of recurrence or exacerbation of disease, as well as in patients who discontinue Raptiva and are non-responders, the treating physician should institute the most appropriate psoriasis treatment as necessary.
F’ każli jerġa joħroġ il- psorjażi jew jsir iktar għar, kif ukoll f’ pazjienti li jitwaqqfu Raptiva u huma ‘ non- responders, it- tabib irid juża l- kura għal psorjażi aktar adegwat, kif inhu meħtieġ.
In case re-treatment with Raptiva is indicated the same guidance should be followed as under Posology and method of administration.
4 F’ każijiet fejn il- kura ma ’ Raptiva terġa tkun indikata, wieħed jrid isegwi l- istess gwidi li hemm ta] t Pożoloġija u metodu ta ’ kif għandu jingħata.
Re-treatment may be associated with lower or inadequate response to Raptiva than in the earlier treatment periods.
Il- kura li jerġa jingħata tista ’ tkun assoċjata ma ’ risposta li tkun inqas jew inadegwata meta tqabbel ma ’ kuri li saru qabel ma ’ Raptiva.
Therapy may be continued only in those patients who respond adequately to treatment.
Il- kura jista jitkompli biss f’ dawk il- pazjienti li jirrispondu b’ mod adegwat g] al kura.
4 Special patient populations No differences in safety or efficacy were observed between elderly (≥ 65 years) patients and younger patients.
Popolazzjoni ta ’ pazjenti spe`jali Ma ġewx osservati differenzi fis- sigurta jew effikaċja bejn l- anzjani (≥ 65 sena) u pazjienti aktar zg] ar.
As there is a higher incidence of infections in the elderly population in general, caution should be used in treating the elderly.
Peress illi, ġeneralment, hemm riskju akbar ta ’ infezzjonijiet fl- anzjani, hemm bzonn ta ’ iktar kawtela waqt il- kura.
Raptiva has not been studied in patients with renal or hepatic impairment and should therefore be used with caution in such patients.
Raptiva ma ġiex studjat f’ pazjienti b’ indeboliment tal- kliewi jew tal– fwied, u għalhekk jrid jintuza b’ kawtela f’ dawn il- pazjienti.
See section 4.8 regarding the effects on the hepatic function.
Ara sezzjoni 4. 8 fuq l- effetti fuq il- fwied.
There have been no formal drug interaction studies performed with Raptiva.
Ma sarux studji formali fuq mediċinali oħra li ma jaqblux ma ’ Raptiva.
Limited data are available on the effects of vaccination in patients receiving Raptiva.
Hemm informazzjoni limitata fuq l- effetti tat- tilqim f’ pazjienti li qegħdin jieħdu Raptiva.
In a study of 66 patients with moderate plaque psoriasis, immune responses during and after Raptiva treatment were investigated.
F’ studju ta ’ 66 pazjienti b’ psorjażi plaque moderata, ġew investigati r- risposti immuni waqt u wara l - kura ma ’ Raptiva.