qanastek/EMEA-V3 huggingface dataset:
lactose monohydrate
lactose monohydrate
See leaflet for further information.
Ara l- fuljett għal aktar tagħrif
28 film-coated tablets
28 pillola miksijin b’ rita
For oral once-a-day use.
Għal użu orali darba kuljum.
How to take CIALIS Once-A-Day
Kif għandek tieħu CIALIS Darba Kuljum
Start with the pill from the blister pack that corresponds with the day you start taking CIALIS.
1. Ibda bil- pillola mill- pakkett tal- folji li tikkorrispondi mal- ġurnata li se tibda tieħu CIALIS.
3.
2. Ħu CIALIS kuljum ma ’ l- ilma bejn wieħed u ieħor dejjem fl- istess ħin, ma ’ l- ikel jew fuq stonku vojt.
When taken once a day CIALIS allows you to obtain an erection, when sexually stimulated, at any time point during the 24 hours of the day.
3. Meta jittiehed darba kuljum CIALIS iħallik tikseb erezzjoni, meta stimulat sesswalment, f’ kull ħin fl- 24 siegħa tal- ġurnata.
You and your partner will need to engage in foreplay, just as you would if you were not taking a medicine for erectile dysfunction.
Ikun hemm bżonn li inti u l- partner tiegħek tistimulaw sesswalment lilkom infuskom qabel ma jkollkom x’ taqsmu, l- istess kif kont tagħmel jekk ma kontx qiegħed tieħu xi mediċina għad- disfunzjoni erettili.
• Always take CIALIS exactly as your doctor has told you.
• Dejjem għandek tieħu CIALIS skond il- parir tat- tabib.
Check with your doctor or pharmacist if you are not sure. • Drinking alcohol may affect your ability to get an erection so avoid excessive drinking with CIALIS. • You should NOT take CIALIS more than once a day.
Aċċerta ruħek mat- tabib jew ma ’ l - ispiżjar jekk ikollok xi dubju • L- alkoħol jista ’ jaffettwa l- kapaċità tiegħek li jkollok erezzjoni għalhekk għandek tevita x- xorb żejjed meta tieħu CIALIS • M’ GĦANDEKX tieħu CIALIS iżjed minn darba kuljum.
If you take more than you should, tell your doctor.
Jekk tieħu iżjed milli suppost, għid lit - tabib tiegħek.
EXP {MM/ YYYY}
JIS [XX/ SSSS]
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
PREKAWZJONIJIET SPEĊJALI GĦAR - RIMI TA ’ PRODOTTI MEDIĊINALI MHUX UŻATI JEW SKART MINN DAWN IL- PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN
Lot.
Lott.
51 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
51 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
CIALIS 5 mg film-coated tablets tadalafil
CIALIS 5 mg pilloli miksijin b’ rita Tadalafil
Each tablet contains 5 mg tadalafil
Kull pillola fiha 5 mg tadalafil
14 film-coated tablets 28 film-coated tablets
14- il pillola miksijin b’ rita 28 pillola miksijin b’ rita
You and your partner will need to engage in foreplay, just as you would if you were not taking a medicine for erectile dysfunction.
Ikun hemm bżonn li inti u s- sieħba tiegħek tistimulaw sesswalment lilkom infuskom qabel ma jkollkom x’ taqsmu, l- istess kif kont tagħmel jekk ma kontx qiegħed tieħu xi mediċina għad- disfunzjoni erettili.
Keep out of the reach and sight of children.
52 Żomm fejn ma jintlaħaqx u ma jidhirx mit- tfal.
{MM/ YYYY}
JIS [XX/ SSSS]
53 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
53 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
CIALIS 10 mg film-coated tablets tadalafil
CIALIS 10 mg pilloli miksijin b’ rita Tadalafil
Each tablet contains 10 mg tadalafil
Kull pillola fiha 10 mg tadalafil
4 film-coated tablets
4 pilloli miksijin b’ rita
55 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
55 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
CIALIS 20 mg film-coated tablets tadalafil
CIALIS 20 mg pilloli miksijin b’ rita Tadalafil
Each tablet contains 20 mg tadalafil
Kull pillola fiha 20 mg tadalafil
2 film-coated tablets 4 film-coated tablets 8 film-coated tablets 12 film-coated tablets
2 pilloli miksijin b’ rita 4 pilloli miksijin b’ rita 8 pilloli miksijin b’ rita 12- il pillola miksijin b’ rita
Store in the original package in order to protect from moisture.
56 Aħżen fil- pakkett oriġinali sabiex tilqa ’ mill- umdità.
57 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER
57 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI FOLJA
CIALIS 2.5 mg tablets tadalafil
CIALIS 2. 5 mg pilloli tadalafil
MON, TUE, WED, THU, FRI, SAT, SUN
TNE, TLI, ERB, ĦAM, ĠIM, SIB, ĦAD
58 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTERS
58 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI FOLJI
CIALIS 5 mg tablets tadalafil
CIALIS 5 mg pilloli tadalafil
59 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER
59 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
CIALIS 10 mg tablets tadalafil
CIALIS 10 mg pilloli Tadalafil
60 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER
60 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
CIALIS 20 mg tablets tadalafil
CIALIS 20 mg pilloli Tadalafil
62 PACKAGE LEAFLET:
62 FULJETT TA ’ TAGĦRIF:
CIALIS 2.5 mg film-coated tablets tadalafil
CIALIS 2. 5 mg pilloli miksijin b’ rita tadalafil
if their symptoms are the same as yours.
il- ħsara, anki jekk ikollom l- istess sintomi bħal tiegħek.
What CIALIS is and what it is used for 2.
X’ inhu CIALIS u għalxiex jintuża 2.
Before you take CIALIS 3.
Qabel ma tieħu CIALIS 3.
How to take CIALIS 4.
Kif għandek tieħu CIALIS 4.
Possible side effects 5 How to store CIALIS 6.
Effetti sekondarji li jista ’ jkollu 5.
Further information
Kif taħżen CIALIS 6.
WHAT CIALIS IS AND WHAT IT IS USED FOR
X ’ INHU CIALIS U GĦALXIEX JINTUŻA
CIALIS is a treatment for men with erectile dysfunction.
CIALIS huwa trattament għall- irġiel b’ disfunzjoni erettili.
This is when a man cannot get, or keep a hard, erect penis suitable for sexual activity.
Dan jiġri meta raġel ma jkunx jista` jkollu, jew iżomm, pene iebes u erett kif inhu xieraq għall- attivita ’ sesswali.
CIALIS belongs to a group of medicines called phosphodiesterase type 5 inhibitors.
CIALIS jagħmel parti minn grupp ta ’ mediċini msejħa inibituri tal- phosphodiesterase tip 5.
Following sexual stimulation CIALIS works by helping the blood vessels in your penis to relax, allowing the flow of blood into your penis.
Wara l - istimolu sesswali, CIALIS jaħdem billi jgħin lill- arterji fil- pene tiegħek jirrilassaw, u b’ hekk jippermettu d- dħul tad- demm fil- pene tiegħek.
The result of this is improved erectile function.
Ir- riżultat ta ’ dan huwa funzjoni erettili mtejba.
CIALIS will not help you if you do not have erectile dysfunction.
CIALIS ma jgħinekx jekk m ’ għandekx disfunzjoni erettili.
It is important to note that CIALIS does not work if there is no sexual stimulation.
Huwa importanti li tkun taf li CIALIS ma jaħdimx jekk ma jkunx hemm stimolu sesswali.
You and your partner will need to engage in foreplay, just as you would if you were not taking a medicine for erectile dysfunction.
Hemm bżonn li int u s- sieħba tiegħek tibdew il- logħob ta ’ qabel l- kopulazzjoni sesswali, kif kontu tagħmlu kieku ma kontx qiegħed tieħu l- mediċina għad- disfunzjoni erettili.
BEFORE YOU TAKE CIALIS
QABEL MA TIEĦU CIALIS
Do not take CIALIS
Tieħux CIALIS
- if you are allergic (hypersensitive) to tadalafil or any of the other ingredients of CIALIS.
– jekk inti allerġiku (tbati minn sensittività eċċessiva) għal tadalafil jew għal xi sustanzi oħra ta ’ CIALIS
This is a
- jekk int qed tieħu xi forma ta ’ nitrate organiku jew donaturi ta 'nitric oxide bħal amyl nitrite.
group of medicines (“ nitrates”) used in the treatment of angina pectoris (“ chest pain”).
Dan huwa grupp ta ’ mediċini (“ nitrati ”) li jintużaw fit- trattament ta ’ angina pectoris (“ uġigħ fis - sider ”).
CIALIS has been shown to increase the effects of these medicines.
CIALIS intwera li jżid l- effetti ta ’ dawn il- mediċini.
If you are taking any form of nitrate or are unsure tell your doctor.
Jekk qed tieħu xi forma ta ’ nitrate jew m ’ intix ċert, għid lit- tabib tiegħek.
- if you have serious heart disease or have had a recent heart attack.
- jekk għandek mard serju tal- qalb jew kellek attakk tal- qalb reċenti.
- if you have had a recent stroke.
- jekk kellek puplesija reċenti.
- if you have low blood pressure or uncontrolled high blood pressure.
- jekk għandek pressjoni tad- demm baxxa jew pressjoni tad- demm għolja mhux ikkontrollata.
63 Take special care with CIALIS
63 – jekk qatt kellek telf tal- vista minħabba newropatija ottika iskemika anterjuri li m’ hijiex arteritika (NAION), kundizzjoni li xi kultant tiġi deskritta bħal “ puplesija ta ’ l- għajn ”
Be aware that sexual activity carries a possible risk to patients with heart disease because it puts an extra strain on your heart.
Kun af li l- attivita ’ sesswali għandha riskju possibbli għal pazjenti li jbatu minn mard tal- qalb għaliex tagħmel sforz żejjed fuq il- qalb.
If you have a heart problem you should tell your doctor.
Jekk għandek problema tal- qalb għandek tgħid lit- tabib tiegħek.
The following are reasons why CIALIS may also not be suitable for you.
Dawn li ġejjin huma raġunijiet għaliex CIALIS jista ’ ma jkunx xieraq għalik.
If any of them apply to you, talk to your doctor before you take the medicine:
Jekk xi waħda minnhom tgħodd għalik, kellem lit- tabib tiegħek qabel ma tieħu l- mediċina:
- You have sickle cell anaemia (an abnormality of red blood cells), multiple myeloma (cancer of
- Għandek anemija tat- tip ‘ sickle cell ’ (abnormalita ’ taċ- ċelloli ħomor tad- demm), majeloma
the bone marrow), leukaemia (cancer of the blood cells) or any deformation of your penis.
multipla (kanċer tal- mudullun), lewkimja (kanċer taċ- ċelloli tad- demm) jew kwalunkwe deformazzjoni tal- pene tiegħek
- You have a serious liver problem.
- Għandek problema serji tal- fwied
- You have a severe kidney problem.
– Għandek problema serja tal- kliewi
It is not known if CIALIS is effective in patients who have undergone pelvic surgery or radical non- nerve-sparing prostatectomy.
M’ huwiex magħruf jekk Cialis huwa effettiv f’ pazjenti li kellhom kirurġija pelvika jew prostatektomija radikali li affetwat in- nervituri.
If you experience sudden decrease or loss of vision, stop taking CIALIS and contact your doctor immediately.
Jekk f’ daqqa waħda tesperjenza tnaqqis jew telf tal- vista, waqqaf CIALIS u kkuntattja t- tabib tiegħek minnufih.
CIALIS is not intended for use by women or by adolescents under the age of 18.
CIALIS m’ huwiex magħmul biex jiġi użat min- nisa jew minn adolexxenti taħt it- tmintax- il sena
Using other medicines
Meta tuża mediċini oħra
Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription, because they might interact.
Jekk jogħġbok għid lit- tabib tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr ricetta, għaliex jistgħu jirrejaġixxu ma ’ xulxin.
This is particulary important if you are treated with nitrates as you should not take CIALIS if you are taking these medicines.
Dan huwa partikolarment importanti jekk inti tkun qed tieħu nitrati għaliex m ’ għandekx tieħu CIALIS jekk qed tieħu dawn il- mediċini.
A type of medicine called an alpha blocker is sometimes used to treat high blood pressure and enlarged prostate.
Tip ta ’ mediċina li tissejjaħ imblokkatur tar- riċetturi alfa xi kultant tintuża għal pressjoni għolja tad - demm u għal prostata mkabbra.
Tell your doctor if you are being treated for either of these conditions or if you take other medicines to treat high blood pressure.
Informa lit- tabib tiegħek jekk qed tiġi ttrattat għal xi waħda minn dawn il- kundizzjonijiet jew jekk qed tieħu mediċini oħra għal kura ta ’ pressjoni għolja fid- demm.
If you are taking medicines that can inhibit an enzyme called CYP3A4 (for example ketoconazole or protease inhibitors for treatment of HIV) the frequency of side effects might increase.
Jekk qed tieħu mediċini li jistgħu jinibixxu enzima li tissejjaħ CYP3A4 (per eżempju ketoconazole jew inibituri ta ’ protease għall- kura ta ’ l- HIV) il- frekwenza ta ’ l- effetti mhux mixtieqa tista ’ tiżdied.
Do not take CIALIS with other medicines if your doctor tells you that you may not.
Tieħux CIALIS ma ’ mediċini oħra jekk it- tabib jgħidlek li ma tistax.
You should not use CIALIS together with any other treatments for erectile dysfunction.
M ’ għandekx tuża CIALIS flimkien ma ’ trattamenti oħrajn għal disfunzjoni erettili.
Taking CIALIS with food and drink You may take CIALIS with or without food.
Meta tieħu CIALIS ma ’ l- ikel u max- xorb Tista ’ tieħu CIALIS ma ’ l- ikel jew fuq stonku vojt.
Information on the effect of alcohol is in section 3.
Tagħrif dwar l- effett ta ’ l- alkoħol qiegħed f’ sezzjoni 3.
Driving and using machines Some men taking CIALIS in clinical studies have reported dizziness.
Sewqan u tħaddim ta ’ magni Xi rġiel li ħadu CIALIS fl- istudji kliniċi rrapurtaw li kellhom xi sturdament.
Check carefully how you react to the medicines before driving or using any machinery.
Oqgħod attent kif tirrejaġixxi għal mediċini qabel ma ssuq jew tħaddem xi magni.
CIALIS contains lactose.
Taghrif importanti dwar xi wħud mis- sustanzi ta ’ CIALIS CIALIS fih lactose.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Jekk it- tabib qallek li għandek xi intolleranza għal xi zokkor, ikkuntattja lit- tabib qabel ma tieħu dan il- prodott mediċinali.
HOW TO TAKE CIALIS
KIF GĦANDEK TIEĦU CIALIS
Always take CIALIS exactly as your doctor has told you.
64 Dejjem għandek tieħu CIALIS skond il- parir tat- tabib.
Once a day dosing of CIALIS may be useful to men who anticipate having sexual activity two or more times per week.
Doża ta ’ CIALIS darba kuljum tista ’ tkun utili għall- irġiel li jaħsbu li jkollom attività sesswali darbtejn jew iżjed fil- ġimgħa.
The recommended dose is one 5 mg tablet taken once a day at approximately the same time of the day.
Id- doża rakkmandata hija ta ’ pillola waħda ta ’ 5 mg darba kuljum li tittieħed bejn wieħed u ieħor dejjem fl- istess ħin..
Your doctor may adjust the dose to 2.5 mg based on your response to CIALIS.
It- tabib tiegħek jista ’ jaġġusta d- doża għal 2. 5 mg skond ir- rispons tiegħek għal CIALIS.
CIALIS tablets are for oral use.
Il- pilloli ta ’ CIALIS huma għall- użu orali.
Swallow the tablet whole with some water.
Ibla ’ l- pillola sħiħa bi ftit ilma.
You may take CIALIS with or without food.
Tista ’ tieħu CIALIS ma ’ l- ikel jew fuq stonku vojt.
When taken once a day CIALIS allows you to obtain an erection, when sexually stimulated, at any time point during the 24 hours of the day.
Meta jittiehed darba kuljum CIALIS iħallik tikseb erezzjoni, meta stimulat sesswalment, f’ kull ħun fl - 24 siegħa tal- ġurnata.
You and your partner will need to engage in foreplay, just as you would if you were not taking a medicine for erectile dysfunction.
Ikun hemm bżonn li inti u s- sieħba tiegħek tistimulaw sesswalment lilkom infuskom qabel ma jkollkom x’ taqsmu, l- istess kif kont tagħmel jekk ma kontx qiegħed tieħu xi mediċina għad - disfunzjoni erettili
Drinking alcohol may affect your ability to get an erection.
Ix- xorb ta ’ l- alkoħol jista ’ jaffettwa l- kapaċita ’ li jkollok erezzjoni.
Drinking alcohol may temporarily lower your blood pressure.
Ix- xorb ta ’ l- alkoħol jista ’ temporanjament ibaxxilek il- pressjoni tad- demm.
If you have taken or are planning to take CIALIS, avoid excessive drinking (blood alcohol level of 0.08% or greater), since this may increase the risk of dizziness when standing up.
Jekk ħadt jew ser tieħu CIALIS, evita li tixrob alkoħol eċċessiv (livell ta ’ alkoħol fid- demm ta ’ 0. 08% jew aktar), minħabba li dan jista ’ jżid ir- riskju ta ’ sturdament meta tkun bil- wieqfa.
You should NOT take CIALIS more than once a day.
M’ GĦANDEKX tieħu CIALIS aktar minn darba kuljum..
If you take more CIALIS than you should Tell your doctor.
Jekk tieħu CIALIS aktar milli suppost Għid lit- tabib tiegħek.
If you forget to take CIALIS Do not take a double dose to make up for a forgotten tablet.
Jekk tinsa tieħu CIALIS M’ għandekx tieħu doża doppja biex tpatti għal kull pillola li tkun insejt tieħu.
Like all medicines, CIALIS can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, CIALIS jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
These effects are normally mild to moderate in nature.
Dawn l- effetti normalment ikunu ta ’ natura ħafifa jew moderata
In this leaflet, when a side effect is described as “ very common” this means that it has been reported in at least 1 in 10 patients taking the medicine.
F’ dan il- fuljett meta effett sekondarju jiġi deskritt bħala “ komuni ħafna ” dan ifisser li ġie rrapportat f’ għallinqas pazjent 1 minn kull 10 pazjenti li qegħdin jieħdu din il- mediċina.
When a side effect is described as “ common” this means that it has been reported in more than 1 in every 100 patients but less than 1 in every 10 patients.
Meta effett sekondarju jiġi deskritt bħala “ komuni ” dan ifisser li ġie rrapportat f’ iżjed minn 1 minn kull 100 pazjent iżda inqas minn 1 minn kull 10 pazjenti.
When a side effect is described as “ uncommon”, this means it has been reported in more than 1 in every 1,000 patients, but less than 1 in every 100 patients.
Meta effett sekondarju jiġi deskritt bħala “ mhux komuni ” dan ifisser li ġie rrapportat f’ iżjed minn 1 minn kull 1000 pazjent iżda inqas minn 1 minn kull 100 pazjent.
When a side effect is described as “ rare”, this means it has been reported in more than 1 in every 10,000 patients, but less than 1 in every 1,000 patients.
Meta effett sekondarju jiġi deskritt bħala “ rari ” dan ifisser li ġie rrapportat f’ iżjed minn 1 minn kull 10000 pazjent iżda inqas minn 1 minn kull 1000 pazjent.
Very commonly reported side effects in patients taking CIALIS were headache and indigestion.
Effetti sekondarji rrapportati b’ mod komuni ħafna f’ pazjenti li qed jieħdu CIALIS kienu uġigħ ta ’ ras u indiġestjoni.
Commonly reported side effects in patients taking CIALIS include back pain, muscle aches, facial flushing, nasal congestion, dizziness, pounding heartbeat sensation, abdominal pain and reflux.
Effetti sekondarji li b’ mod komuni jiġu rrapportati f’ pazjenti li qegħdin jieħdu CIALIS jinkludu uġigħ tad- dahar. uġigħ fil- muskoli,, ħmura fil- wiċċ, imnieħer miżdud, sturdament, sensazzjoni li l- qalb qed tħabbat ħafna, uġigħ addominali u rifluss.
Uncommon side effects are allergic reactions including rashes and hives, blurred vision, swelling of the eyelids, eye pain, red eyes, increased sweating, nose bleeds, a fast heart rate, high blood pressure, low blood pressure and chest pain.
Effetti sekondarji mhux komuni huma reazzjonijiet allerġiċi li jinkludu raxx u urtikarja, vista mċajpra, nefħa tal- kpiepel ta ’ l- għajnejn, uġigħ fl- għajnejn, għajnejn ħomor, żieda fl- għaraq, l- infriġ, il- qalb tħabbat b’ rata mgħaġġla, pressjoni għolja tad- demm, pressjoni baxxa tad- demm u uġigħ fis- sider.
In case of chest pain occurring during or after sexual activity you should NOT use nitrates but you should seek immediate medical assistance.
F’ każ li tħoss uġigħ fis- sider matul jew wara l- attivita ’ sesswali, m ’ GĦANDEKX tuża nitrati iżda għandek tfittex assistenza medika immedjata.
Rare side effects in patients taking CIALIS include fainting, migraine and swelling of the face.
65 Effetti sekondarji rari f’ pazjenti li qegħdin jieħdu CIALIS jinkludu ħass ħażin, emikranja u nefħa fil - wiċċ
65 In rare instances it is possible that a prolonged and possibly painful erection may occur after taking CIALIS.
F’ każijiet rari huwa possibbli li sseħħ erezzjoni fit- tul u possibilment li tweġġa ’ wara li tieħu CIALIS.
If you have such an erection, which lasts continuously for more than 4 hours, you should contact a doctor immediately.
Jekk għandek din l- erezzjoni, li tibqa ’ kontinwament għal aktar minn 4 sigħat, għandek tikkuntattja tabib minnufih.
Heart attack and stroke have also been reported rarely in men taking CIALIS.
B’ mod rari ġew ukoll irrapportati attakk tal- qalb u puplesija f’ irġiel li ħadu CIALIS.
Most, but not all of these men had known heart problems before taking this medicine.
Ħafna minn dawn l- irġiel, iżda mhux kollha, kellhom problemi tal- qalb magħrufa minn qabel ma ħadu din il- mediċina.
It is not possible to determine whether these events were directly related to CIALIS.
Mhux possibbli li jkun determinat jekk dawn l- avvenimenti kinux relatati ma ’ CIALIS.
Partial, sudden, temporary, or permanent decrease or loss of vision in one or both eyes has been rarely reported.
B’ mod rari, ġew irrappurtati każi ta ’ tnaqqis jew telf ta ’ vista, parzjali, għal għarrieda, temporanji jew permanenti f’ għajn waħda jew fit- tnejn li huma.
Some additional side effects have been reported in men taking CIALIS that were not seen in clinical trials and their incidence is unknown.
F’ irġiel li ħadu CIALIS ġew irrapportati xi effetti sekondarji oħra li ma dehrux f’ studji kliniċi u l - inċidenza tagħhom m’ hijiex magħrufa.
These include seizures and passing memory loss, some disorders affecting blood flow to the eyes, irregular heartbeats and angina, serious skin rashes and sudden cardiac death.
Dawn jinkludu, konvulżjonijiet u telf tal- memorja li tgħaddi, xi disturbi li jkollhom effett fuq il- fluss tad- demm fl- għajnejn, taħbit irregolari tal- qalb u anġina, raxx sever tal- ġilda u mewta kardijaka għal għarrieda.
Sudden decrease or loss of hearing has been reported.
Ġie rrapportat nuqqas jew telf tas- smigħ f’ daqqa.
Effects were seen in one animal species that might indicate impairment of fertility.
Dehru effetti fi speċji waħda ta ’ annimal li jistgħu jindikaw ħsara fil- fertilita ’.
Subsequent studies in man suggest that this effect is unlikely in humans, although a decrease in sperm concentration was seen in some men.
Studji sussegwenti fil - bniedem juru li dan l- effett mhuwiex probabbli fil- bnedmin, għalkemm f’ xi rġiel ġiet osservata tnaqqis fil- konċentrazzjoni ta ’ sperma.
HOW TO STORE CIALIS
KIF TAĦŻEN CIALIS
Do not use CIALIS after the expiry date stated on the carton and blister.
Tużax CIALIS wara d- data ta ’ skadenza li tidher fuq il- kartuna u l- folja.
Do not store above 30°C Medicines should not be disposed of via wastewater or household waste.
Taħżinx f’ temperatura ’ l fuq minn 30°C.
FURTHER INFORMATION
X’ fih CIALIS
What CIALIS contains The active substance is tadalafil.
Is- sustanza attiva hi tadalafil.
Each tablet contains 2.5 mg of tadalafil.
Kull pillola fiha 2. 5 mg tadalafil.
Film-coat: lactose monohydrate, hypromellose, triacetin, titanium dioxide (E171), iron oxide yellow (E172), iron oxide red (E172) talc.
Kisja b’ rita: lactose monohydrate, hypromellose, triacetin, titanium dioxide (E171), iron oxide isfar (E172), iron oxide aħmar (172) talkum.
What CIALIS looks like and contents of the pack CIALIS 2.5 mg strength comes as orange-yellow film-coated tablets.
Id- Dehra ta ’ CIALIS u l- kontenuti tal- pakkett CIALIS 2. 5 mg jiġi bħala pilloli oranġjo- sofor miksijin b’ rita.
They are in the shape of almonds and have "C 2 ½" marked on one side.
Dawn għandhom forma ta ’ lewża, u huma mmarkati "C 2½" fuq naħa waħda.
CIALIS 2.5 mg is available in blister packs containing 28 tablets.
CIALIS 2. 5 mg issibu f’ pakketti b’ folji li fihom 28 pillola.
Marketing Authorisation Holder and Manufacturer
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq u l- Manifattur
Marketing Authorisation Holder:
66 Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq:
Eli Lilly Nederland B. V., Grootslag 1-5, NL-3991 RA, Houten, The Netherlands
Eli Lilly Nederland BV, Grootslag 1- 5, NL - 3991 RA Houten, L- Olanda.
Lilly S. A., Avda. de la Industria 30, 28108 Alcobendas, Madrid, Spain.
Lilly S. A., Avda. de la Industria 30, 28108 Alcobendas, Madrid, Spanja.
66 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:
Deutschland Lilly Deutschland GmbH Tel. + 49-(0) 6172 273 2222
Eesti filiaal
Eesti filiaal Tel: +372 6441100
Tel: +372 6441100 Ελλάδα ΦΑΡΜΑΣΕΡΒ- ΛΙΛΛΥ Α. Ε. Β. Ε Τηλ: +30 210 629 4600 España Lilly, S. A.
Österreich Eli Lilly Ges. m. b. H.
Tel: + 34 91 623 1732 France Lilly France S. A. S Tél.: +33 - (0) 1 55 49 34 34 Ireland Eli Lilly and Company (Ireland) Limited.
Tel: +43-(0) 1 711 780
Tel: +353 - (0) 1 661 4377
Tel: + 40 21 4023000
Tel: + 40 21 4023000 Slovenija Eli Lilly, farmacevtska družba, d. o. o.
Simi: + 354 540 8000
Simi: + 354 540 8000
Suomi/ Finland Oy Eli Lilly Finland Ab.
Suomi/ Finland Italia Oy Eli Lilly Finland Ab.
Puh/ Tel: + 358-(0) 9 85 45 250
Eli Lilly Italia S. p. A.
Latvija Eli Lilly Holdings Limited pā rstā vniecī ba Latvijā Tel: +371 7364000
Latvija Eli Lilly Holdings Limited pārstāvniecība Latvijā Tel: +371 7364000 Lietuva Eli Lilly Holdings Limited atstovybė Tel. +370 (5) 2649600 Dan il- fuljett kien approvat l- aħħar f ’ [data]
Lietuva Eli Lilly Holdings Limited atstovybė Tel. +370 (5) 2649600
Informazzjoni dettaljata dwar din il- mediċina tinsab Mediċini (EMEA) http: // www. emea. europa. eu /
This leaflet was last approved in {date}
fuq il- website ta ’ l- Aġenzija Ewropeja dwar il -
68 PACKAGE LEAFLET:
67 FULJETT TA ’ TAGĦRIF:
CIALIS 5 mg film-coated tablets tadalafil
CIALIS 5 mg pilloli miksijin b’ rita tadalafil
(NAION), a condition sometimes described as “ stroke of the eye”.
68 – jekk qatt kellek telf tal- vista minħabba newropatija ottika iskemika anterjuri li m’ hijiex arteritika (NAION) kundizzjoni li xi kultant tiġi deskritta bħal “ puplesija ta ’ l- għajn ”
Take special care with CIALIS
Oqgħod attent ħafna b’ CIALIS
It is not known if CIALIS is effective in patients who have undergone pelvic surgery or radical non- nerve-sparing prostatectomy
M’ huwiex magħruf jekk Cialis huwa effettiv f’ pazjenti li kellhom kirurġija pelvika jew prostatektomija radikali li affetwat in- nervituri.
Using other medicines Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription, because they might interact.
Jekk jogħġbok għid lit- tabib tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr ricetta, għaliex jistgħu jirrejaġixxu ma ’ xulxin.
This is particularly important if you are treated with nitrates as you should not take CIALIS if you are taking these medicines.
Dan huwa partikolarment importanti jekk inti tkun qed tieħu nitrati għaliex m ’ għandekx tieħu CIALIS jekk qed tieħu dawn il- mediċini.
70 3.
69 3.
Always take CIALIS exactly as your doctor has told you.
Dejjem għandek tieħu CIALIS skond il- parir tat- tabib.
You should NOT take CIALIS more than once a day.
M’ GĦANDEKX tieħu CIALIS aktar minn darba kuljum.
In case of chest pain occurring during or after sexual activity you should NOT use nitrates but you should seek immediate medical assistance.
70 F’ każ li tħoss uġigħ fis- sider matul jew wara l- attivita ’ sesswali, m ’ GĦANDEKX tuża nitrati iżda għandek tfittex assistenza medika immedjata.
Rare side effects in patients taking CIALIS include fainting, migraine and swelling of the face.
Effetti sekondarji rari f’ pazjenti li qegħdin jieħdu CIALIS jinkludu ħass ħażin, emikranja u nefħa fil - wiċċ
71 In rare instances it is possible that a prolonged and possibly painful erection may occur after taking CIALIS.
F’ każijiet rari huwa possibbli li sseħħ erezzjoni fit- tul u possibilment li tweġġa ’ wara li tieħu CIALIS.
Each tablet contains 5 mg of tadalafil.
Kull pillola fiha 5 mg tadalafil.
Film-coat: lactose monohydrate, hypromellose, triacetin, titanium dioxide (E171), iron oxide yellow (E172), talc.
Kisja b’ rita: lactose monohydrate, hypromellose, triacetin, titanium dioxide (E171), iron oxide isfar (E172), talkum.
What CIALIS looks like and contents of the pack CIALIS 5 mg strength comes as light yellow film-coated tablets.
Id- Dehra ta ’ CIALIS u l- kontenuti tal- pakkett CIALIS 5 mg jiġi bħala pilloli sofor ċari miksijin b’ rita.
They are in the shape of almonds and have "C 5" marked on one side.
Dawn għandhom forma ta ’ lewża, u huma mmarkati "C 5" fuq naħa waħda.
CIALIS 5 mg is available in blister packs containing 14 or 28 tablets.
CIALIS 5 mg issibu f’ pakketti b’ folji li fihom 14 jew 28 pillola.
Not all pack sizes may be marketed.
71 Jista ’ jkun li mhux il- pakketti tad- daqsijiet kollha jkunu għal skop kummerċjali.
72 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:
България ТП "Ели Лили Недерланд "Б .В. - България тел. + 359 2 491 41 40
Tél/ Tel: +32 - (0) 2 548 84 84 България ТП "Ели Лили Недерланд" Б. В. - България тел. + 359 2 491 41 40
Magyarország Lilly Hungária Kft Tel: + 36 1 328 5100
Tél/ Tel: +32 - (0) 2 548 84 84 Magyarország Lilly Hungária Kft Tel: + 36 1 328 5100
Tel: + 420 234 664 111
Eesti filiaal
Tel: + 39- 055 42571
Tel: + 39 - 055 42571 Κύπρος Phadisco Ltd Τηλ: +357 22 715000 Latvija Eli Lilly Holdings Limited pārstāvniecība Latvijā Tel: +371 7364000
Suomi/ Finland Oy Eli Lilly Finland Ab.
Suomi/ Finland Oy Eli Lilly Finland Ab.
Lietuva Eli Lilly Holdings Limited atstovybė Tel. +370 (5) 2649600
72 Lietuva Eli Lilly Holdings Limited atstovybė Tel. +370 (5) 2649600
This leaflet was last approved in {date}
Dan il- fuljett kien approvat l- aħħar f ’ [data]
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http: / /www. emea. europa. eu
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il - Mediċini (EMEA) http: // www. emea. europa. eu /
74 PACKAGE LEAFLET:
73 FULJETT TA ’ TAGĦRIF:
CIALIS 10 mg film-coated tablets tadalafil
CIALIS 10 mg pilloli miksijin b’ rita tadalafil
- if you have had a recent stroke
- jekk kellek puplesija reċenti.
(NAION), a condition sometimes described as “ stroke of the eye”.
74 – jekk qatt kellek telf tal- vista minħabba newropatija ottika iskemika anterjuri li m’ hijiex arteritika (NAION) kundizzjoni deskritta bħal “ puplesija ta ’ l- għajn ”
75 Take special care with CIALIS
Oqgħod attent ħafna b’ CIALIS
- You have a serious liver problem.
- Għandek problema serji tal- fwied.
- You have a severe kidney problem.
- Għandek problema severa fil- kliewi
Please tell your doctor if you are taking or have recently taken any other medicine, including medicines obtained without prescription, because they might interact.
Jekk jogħġbok għid lit- tabib tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr ricetta, għaliex jistgħu jirrejaġixxu ma ’ xulxin.
The recommended starting dose is one 10 mg tablet before sexual activity.
Id- doża rakkmandata tal- bidu hija pillola ta ’ 10 mg qabel l- attivita ’ sesswali.
If the effect of this dose is too weak your doctor may increase the dose to 20 mg.
Jekk l- effett ta ’ din id - doża huwa ħafif wisq, it- tabib tiegħek jista ’ jżidlek id- doża sa 20 mg.
CIALIS tablets are for oral use.
Il- pilloli ta ’ CIALIS huma għall - użu orali.
You may take a CIALIS tablet at least 30 minutes before sexual activity.
Tista ’ tieħu pillola ta ’ CIALIS mill- inqas 30 minuta qabel l- attivita ’ sesswali.
CIALIS may still be effective up to 36 hours after taking the tablet.
CIALIS jista ’ jibqa ’ effettiv sa 36 siegħa wara li tieħu l- pillola.
You and your partner will need to engage in foreplay, just as you would if you were not taking a medicine for erectile dysfunction.
Hemm bżonn li int u s- sieħba tiegħek tibdew il- logħob ta ’ qabel il - kopulazzjoni sesswali, kif kontu tagħmlu kieku ma kontx qiegħed tieħu mediċina għad- disfunzjoni erettili.
CIALIS 10 mg and 20 mg is intended for use prior to anticipated sexual activity and is not recommended for continuous daily use.
CIALIS 10 mg u 20 mg huwa intenzjonat għall- użu qabel attività sesswali prevista u mhux irrakkomandat għall- użu kontinwu ta ’ kuljum..
Very commonly reported side effect in patients taking CIALIS were headache and indigestion.
Effetti sekondarji li b’ mod komuni ħafna ġew irrapurtati f’ pazjenti li qegħdin jieħdu CIALIS kienu uġigħ ta ’ ras u indiġestjoni.
Commonly reported side effects in patients taking CIALIS include back pain, muscle aches, facial flushing, nasal congestion, dizziness, pounding heartbeat sensation, abdominal pain and reflux.
Effetti sekondarji li b’ mod komuni jiġu rrapportati f’ pazjenti li qegħdin jieħdu CIALIS jinkludu uġigħ tad- dahar. uġigħ fil- muskoli,, ħmura fil- wiċċ, imnieħer miżdud, sturdament. sensazzjoni li l- qalb qed tħabbat ħafna, uġigħ addominali u rifluss.
In rare instances it is possible that a prolonged and possibly painful erection may occur after taking CIALIS.
76 F’ każijiet rari huwa possibbli li sseħħ erezzjoni fit- tul u possibilment li tweġġa ’ wara li tieħu CIALIS.
77 Heart attack and stroke have also been reported rarely in men taking CIALIS.
B’ mod rari ġew ukoll irrapportati attakk tal- qalb u puplesija f’ irġiel li ħadu CIALIS.
Do not use CIALIS after the expiry date stated on the carton and blister.
Tużax CIALIS wara d- data ta ’ l- iskadenza li tidher fuq il- kartuna u l- folja.
Each tablet contains 10 mg of tadalafil.
Kull pillola fiha 10 mg tadalafil.
Film-coat: lactose monohydrate, hypromellose, triacetin, titanium dioxide (E171), iron oxide yellow (E172), talc.
Kisja b’ rita: lactose monohydrate, hypromellose, triacetin, titanium dioxide (E171), iron oxide yellow (E172), talkum.
What CIALIS looks like and contents of the pack CIALIS 10 mg comes as light yellow film-coated tablets.
Id- Dehra ta ’ CIALIS u l- kontenuti tal- pakkett CIALIS 10 mg jiġi bħala pilloli sofor ċari miksijin b’ rita.
They are in the shape of almonds and have "C 10" marked on one side.
Dawn għandhom forma ta ’ lewża, u huma mmarkati "C 10" fuq naħa waħda.
Cialis 10 mg is available in blister packs containing 4 tablets.
Cialis 10 mg issibu f’ pakketti b’ folji ta ’ 4 pilloli.
Manufacturer:
77 Manifattur:
Lilly S. A., Avda. de la Industria 30, 28108 Alcobendas, Madrid, Spain
Lilly S. A., Avda. de la Industria 30, 28108 Alcobendas, Madrid, Spanja.
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:
България ТП "Ели Лили Недерланд "Б .В. - България тел. + 359 2 491 41 40
Tél/ Tel: +32 - (0) 2 548 84 84 Tél/ Tel: +32 - (0) 2 548 84 84 България ТП "Ели Лили Недерланд" Б. В. - България тел. + 359 2 491 41 40 Česká republika ELI LILLY ČR, s. r. o.
Tel: + 420 234 664 111
Eesti filiaal Tel: +372 6441100
Malta Charles de Giorgio Ltd.
Magyarország Lilly Hungária Kft Tel: + 36 1 328 5100 Malta Charles de Giorgio Ltd.
Tel: +43-(0) 1 711 780
Tel: +43 - (0) 1 711 780
Ελλάδα ΦΑΡΜΑΣΕΡΒ -ΛΙΛΛΥ Α .Ε .Β .Ε Τηλ: +30 210 629 4600
Ελλάδα ΦΑΡΜΑΣΕΡΒ- ΛΙΛΛΥ Α. Ε. Β. Ε Τηλ: +30 210 629 4600 España Lilly, S. A.
Tel: +351-21-4126600
Tel.: +48 (0) 22 440 33 00 Portugal Lilly Portugal Produtos Farmacêuticos, Lda.
România Eli Lilly România S. R. L.
Tel: +351- 21- 4126600 România France Eli Lilly România S. R. L.
Tel: + 40 21 4023000
Lilly France S. A. S Tel: + 40 21 4023000 Tél.: +33 - (0) 1 55 49 34 34 Slovenija Ireland Eli Lilly farmacevtska družba, d. o. o.
Tel: +386 (0)1 580 00 10
Tel: +386 (0) 1 580 00 10 Tel: +353 - (0) 1 661 4377 Slovenská republika Ísland Eli Lilly Slovakia, s. r. o.
Slovenská republika Eli Lilly Slovakia, s. r. o.
Tel:
Tel: + 421 220 663 111
421 220 663 111
Puh/ Tel: + 358-(0) 9 85 45 250
Puh/ Tel: + 358 - (0) 9 85 45 250
79 Κύπρος Phadisco Ltd Τηλ: +357 22 715000
Κύπρος Phadisco Ltd Τηλ: +357 22 715000 Latvija Eli Lilly Holdings Limited pārstāvniecība Latvijā Tel: +371 7364000 Lietuva Eli Lilly Holdings Limited atstovybė Tel. +370 (5) 2649600
Sverige Eli Lilly Sweden AB Tel: +46 (0) 8 737 88 00
Sverige Eli Lilly Sweden AB Tel: +46 (0) 8 737 88 00 United Kingdom Eli Lilly and Company Limited Tel: +44 - (0) 1256 315999
80 PACKAGE LEAFLET:
78 FULJETT TA ’ TAGĦRIF:
CIALIS 20 mg film-coated tablets tadalafil
CIALIS 20 mg pilloli miksijin b’ rita tadalafil
- If you have any further questions, ask your doctor or pharmacist.
- Jekk ikollok aktar mistoqsijiet, staqsi lit- tabib jew spiżjar tiegħek.
(NAION), a condition described as “ stroke of the eye”.
79 – jekk qatt kellek telf tal- vista minħabba newropatija ottika iskemika anterjuri li m’ hijiex arteritika (NAION) kundizzjoni deskritta bħal “ puplesija ta ’ l- għajn ”
81 Take special care with CIALIS
Oqgħod attent ħafna b’ CIALIS
- You have a severe kidney problem
- Għandek problema severa fil- kliewi
Using other medicines Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without prescription, because they might interact.
Jekk jogħġbok għid lit- tabib tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr ricetta, għaliex jistgħu jirrejaġixxu ma ’ xulxin.
82 The recommended starting dose is one 10 mg tablet before sexual activity.
Id- doża rakkmandata tal- bidu hija pillola ta ’ 10 mg qabel l- attivita ’ sesswali.
In rare instances it is possible that a prolonged and possibly painful erection may occur after taking CIALIS.
81 F’ każijiet rari huwa possibbli li sseħħ erezzjoni fit- tul u possibilment li tweġġa ’ wara li tieħu CIALIS.
83 Partial, sudden, temporary, or permanent decrease or loss of vision in one or both eyes has been rarely reported.
B’ mod rari, ġew irrappurtati każi ta ’ tnaqqis jew telf ta ’ vista, parzjali, għal għarrieda, temporanji jew permanenti f’ għajn waħda jew fit- tnejn li huma.
Each tablet contains 20 mg of tadalafil.
Kull pillola fiha 20 mg tadalafil.
What CIALIS looks like and contents of the pack CIALIS 20 mg comes as yellow film-coated tablets.
Id- Dehra ta ’ CIALIS u l- kontenuti tal- pakkett CIALIS 20 mg jiġi bħala pilloli sofor miksijin b’ rita.
They are in the shape of almonds and have "C 20" marked on one side.
Dawn għandhom forma ta ’ lewża, u huma mmarkati "C 20" fuq naħa waħda.
CIALIS 20 mg is available in blister packs containing 2, 4, 8 or 12 tablets.
CIALIS issibu f’ pakketti b’ folji ta ’ 2, 4, 8 jew 12- il pillola.
Marketing Authorisation Holder and Manufacturer
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq u l- Manifattur Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq:
Manufacturer:
82 Manifattur:
Tel: + 420 234 664 111
Tel: + 420 234 664 111 Danmark Eli Lilly Danmark A/ S Tlf: +45 45 26 61 00 Deutschland Lilly Deutschland GmbH
Eesti Eli Lilly Holdings Limited.
Tel. + 49 - (0) 6172 273 2222 Eesti Eli Lilly Holdings Limited.
Eesti filiaal Tel: +372 6441100
Eesti filiaal Tel: +372 6441100
Österreich Eli Lilly Ges. m. b. H.
Tlf: + 47 22 88 18 00 Österreich Eli Lilly Ges. m. b. H.
85 Κύπρος Phadisco Ltd Τηλ: +357 22 715000
Κύπρος Phadisco Ltd Τηλ: +357 22 715000 Latvija Eli Lilly Holdings Limited pārstāvniecība Latvijā Tel: +371 7364000 Lietuva Eli Lilly Holdings Limited atstovybė Tel. +370 (5) 2649600
London, 19 March 2008 Doc.
Londra, 19 ta ’ Marzu 2008 Dok.
EMEA/ CHMP/ 145497/ 2008
EMEA/ 224469/ 2008
QUESTIONS AND ANSWERS ON RECOMMENDATION FOR THE REFUSAL OF THE MARKETING AUTHORISATION for CIMZIA
MISTOQSIJA U TWEĠIBA DWAR IR- RAKKOMANDAZZJONI GĦAL RIFJUT TA ’ L - AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ għal CIMZIA
International non-proprietary name (INN): certolizumab pegol
Denominazzjoni Komuni Internazzjonali (INN): certolizumab pegol
On 15 November 2007, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product CIMZIA 200 mg powder and solvent for solution for injection, intended for the treatment of severe, active Crohn’ s disease.
Fil- 15 ta ’ Novembru 2007, il- Kumitat għal Prodotti Mediċinali għal Użu mill- Bniedem (CHMP) adotta opinjoni negattiva, u rrikmanda r- rifjut ta ’ l- awtorizzazzjoni tat- tqegħid fis- suq għall- prodott mediċinali CIMZIA 200 mg fi trab u solvent għas- soluzzjoni f’ forma ta ’ injezzjoni, intiża għat - trattament tal- marda attiva ta ’ Crohn f’ forma severa.
The company that applied for authorisation is UCB Pharma SA.
Il- kumpanija li applikat għall- awtorizzazzjoni hija UCB Pharma SA.
The applicant requested a re-examination of the opinion.
L- applikant talab għal eżami mill- ġdid ta ’ l- opinjoni.
After having considered the grounds for this request, the CHMP re-examined the initial opinion, and confirmed the recommendation for the refusal of the marketing authorisation on 19 March 2008.
Wara li kkunsidraw ir- raġunijet għal din it- talba, is- CHMP reġa ’ eżamina l- opinjoni inizjali u kkonferma r- rifjut ta ’ l- awtorizzazzjoni għat- tqegħid fis - suq fid- 19 ta ’ Marzu 2008.
What is CIMZIA?
X’ inhu CIMZIA?
CIMZIA is a powder and solvent that is made up into a solution for injection under the skin.
CIMZIA huwa trab u solvent magħmula f’ forma ta ’ soluzzjoni għall- injezzjoni taħt il- ġilda.
It contains the active substance certolizumab pegol.
Fih is - sustanza attiva eculizumab pegol.
What was CIMZIA expected to be used for?
Għal xiex kien mistenni li jintuża CIMZIA?
CIMZIA was expected to be used to treat severe, active Crohn’ s disease (a disease causing inflammation of the digestive tract).
CIMZIA kien mistenni li jintuża għat- trattament tal- marda attiva ta ’ Crohn f’ forma severa (marda li tikkawwża infjammazzjoni tal- musrana diġestiva).
It was to be used in patients who had not responded to a full and adequate course of therapy with a corticosteroid or an immunosuppressant medicine (a medicine that reduces the activity of the immune system) or who cannot take these therapies.
Kien użat f’ pazjenti li rrispondew b’ mod sħiħ u b’ mod adegwat matul it- terapija b’ kortikosterojde jew mediċina immunosuppressanti (mediċina li tnaqqas l- attività tas- sistema immunitorja) jew li ma jistgħux jieħdu dawn it- terapiji.
How is CIMZIA expected to work?
Kif kien mistenni li jaħdem CIMZIA?
The active substance in CIMZIA, certolizumab pegol, is an immunosuppressant medicine.
Is- sustanza attiva hija CIMZIA, certolizumab pegol, hija mediċina immunosuppressanti.
It includes certolizumab, which is part of a monoclonal antibody.
Fih iċ - certolizumab, li hija parti monoklonali ta ’ antikorp.
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 in the body.
Antikkorp monoklonali hu tip ta ’ antikorp (tip ta ’ proteina) li ġiet immarkata biex tagħraf u teħel ma ’ struttura speċifika (magħrufa bħala antiġen) li tinstab fil- ġisem.
Certolizumab has been designed to bind to a chemical messenger in the body called tumour necrosis factor-alpha (TNF-alpha).
Adalimumab ġie ddisinjat biex jeħel ma ’ messaġġier kimiku fil- ġisem magħruf bħala fattur tan- nekrożi minn tumur (TNF- alfa).
This messenger is involved in causing inflammation and is found at high levels in patients with active Crohn’ s disease.
Dan il- messaġġier huwa involut fl- ikkawwżar ta ’ infjammazzjoni u jinsab f’ livelli għoljin f’ pazjenti li jbatu mill- marda attiva ta ’ Crohn.
By blocking TNF-alpha, certolizumab was expected to improve the inflammation and other symptoms of the disease.
Certolizumab li jibblokka t- TNF- alfa kien mistenni li jtejjeb is- sitwazzjoni meta jkun hemm infjammazzjoni u sintomi oħrajn tal- marda.
In CIMZIA, certolizumab has been ‘ pegylated’ (attached to a chemical called polyethylene glycol).
F’ CIMZIA, certolizumab ġie pegilat (magħqud flimkien ma ’ kimika li hija msejjħa polijetelina glikola).
This decreases the rate at which the substance is removed from the body and allows the medicine to be given less often.
Dan inaqqas ir- rata li biha s- sustanza titneħħa mill- ġisem u tippermetti li l- mediċina tingħata inqas spiss.
What documentation did the company present to support its application to the CHMP?
X' dokumentazzjoni ppreżentat il- kumpanija għas- sostenn ta 'l- applikazzjoni tagħha lis- CHMP?
The effects of CIMZIA were first tested in experimental models before being studied in humans.
L- effetti ta ’ CIMZIA għall- ewwel ġew ittestjati f’ mudelli sperimentali qabel ma ġew studjati fuq il - bniedem.
The effectiveness of adding CIMZIA to existing treatment was compared with that of placebo (a dummy treatment) in two main studies involving adults with moderate to severe Crohn’ s disease.
L- effikaċja taż- żjieda ta ’ CIMZIA ma ’ trattament eżistenti ġie kumparat ma ’ dak ta ’ placebo (trattament fint) f’ żewġ studji prinċipali li jinvolvu adulti bil- marda ta ’ Crohn f’ forma moderata u severa.
The first study looked at the reduction of symptoms during ‘ induction treatment ’ in 660 patients who had not received CIMZIA before.
L- ewwel studju kopra t- tnaqqis ta ’ sintomi matul it - ‘ trattament tal- bidu ’ f’ 660 pazjent li ma kienux irċevew CIMZIA qabel.
The main measure of effectiveness was the proportion of patients whose symptoms had improved or disappeared after six and 26 weeks.
Il- miżura ta ’ effikaċja prinċipali kienet il- proporzjon ta ’ pazjenti li s- sintomi tagħhom ġew imtejba jew għaddew wara sitt ġimgħat u 26 ġimgħa.
The second study looked at the maintenance of the medicine ’ s effects in 428 patients who had responded to an initial six-week course of CIMZIA.
It- tieni studju ħares lejn iż- żamma ta ’ l- effetti tal- mediċina f’ 428 pazjent li rrispondew għal kors inizjali ta ’ sitt ġimgħat ta ’ CIMZIA.
The main measure of effectiveness was the proportion of the patients who were still responding to treatment after 26 weeks.
Il- miżura prinċipali ta ’ effikaċja kienet il- proporzjon ta ’ pazjenti li kienu għadhom jirrispondu għat- trattament wara 26 ġimgħa.
What were the major concerns that led the CHMP to recommend the refusal of the marketing authorisation?
X’ kien it- tħassib ewlieni li wassal sabiex lis- CHMP sabiex jirrakkomanda r- rifjut ta ’ l - awtorizzazzjoni għat- tqegħid fis- suq?
In November 2007, the CHMP was concerned that there was insufficient evidence to show a benefit of CIMZIA.
F’ Novembru 2007, is- CHMP kienet konċernata li ma kienx hemm evidenza biżżejjed li turi l - benefiċċji ta ’ CIMZIA.
In the study of induction treatment, CIMZIA showed only marginal effectiveness, which was too low to be relevant for patients.
Fl- istudju tat- trattament inizjali, CIMZIA wera effikaċja marġinali biss li kienet baxxa ħafna sabiex tkun rilevanti għal pazjenti.
In addition, the study of maintenance treatment did not last long enough to give meaningful information on the medicine ’ s long-term effects.
Barra minn dan, l- istudju ta ’ trattament ta ’ żamma ma tawwalx biżżejjed sabiex jagħti informazzjoni dwar l- effetti tal- mediċina fuq żmien twil.
The Committee was also concerned over CIMZIA’ s safety: although generally comparable with the safety of other medicines in the same class, there was also some concern over a possible increased risk of bleeding in patients receiving CIMZIA.
Il- Kumitat kien konċernat ukoll dwar is- sigurtà ta ’ CIMZIA. għalkemm meta kumparat b’ mod ġenerali mas- sigurtà ta ’ mediċini oħrajn fl- istess klassi, kien hemm xi tħassib dwar iż- żjieda possibbli ta ’ riskju ta ’ emoraġġija fil- pazjenti li jirċievu CIMZIA.
In addition, the Committee was concerned that the company had not demonstrated that it would have been able to monitor the quality of the medicine to an acceptable level.
Barra minn dan, il- Kumitat kien konċernat dwar jekk il- kumpanija wrietx li ser tkun kapaċi sabiex timmonitorja l- kwalità tal- mediċina f’ livell aċċettabbli.
In March 2008, following the re-examination, the CHMP removed its concern regarding the ability to monitor the medicine ’ s quality.
F’ Marzu 2008, wara eżami mill- ġdid, is- CHMP warrab it- tħassib tagħha rigward il- kapaċità ta ’ monitorjar tal- kwalità tal- mediċina.
It also removed its concern over the possible increased risk of bleeding, but maintained a general concern over CIMZIA’ s safety.
Huwa warrab ukoll it- tħassib tiegħu dwar il- possibilità ta ’ żjieda fir- riskju ta ’ emoraġġija, iżda żamm konċern ġenerali dwar is- sigurtà ta ’ CIMZIA.
The other concerns remained.
It- tħassib l- ieħor baqa ’ eżistenti.
Therefore, at that point in time, the CHMP was of the opinion that the benefits of CIMZIA in the treatment of severe, active Crohn’ s disease did not outweigh its risks.
Għalhekk, f’ dak il- punt, is- CHMP kien ta ’ l- opinjoni li ċ- CIMZIA ma wriex li neħħa r- riskji tiegħu fit- trattament tal- marda ta ’ Crohn f’ forma attiva u meta tkun severa.