qanastek/EMEA-V3 huggingface dataset:
In the 14-week toxicity study etoricoxib caused gastrointestinal ulcers at exposures greater than those seen in man at the therapeutic dose.
Fl - istudju ta ’ 14- il ġimgħa, etoricoxib ikkawża ulċeri gastrointestinali f’ espożizjonijiet ogħla minn dawk li dehru fuq il- bniedem fid- doża terapewtika.
In the 53- and 106-week toxicity study, gastrointestinal ulcers were also seen at exposures comparable to those seen in man at the therapeutic dose.
Fl- istudju tat- tossiċità ta ’ 53 ġimgħa u ta ’ 106 ġimgħa, ulċeri gastrointestinali dehru wkoll f’ espożizzjonijiet komparabbli ma ’ dawk li dehru fil- bniedem fid - doża terapewtika.
In dogs, renal and gastrointestinal abnormalities were seen at high exposures.
Fil- klieb, l- anormalitajiet renali u gastrointestinali dehru f’ espożizzjonijiet għoljin.
Etoricoxib was not teratogenic in reproductive toxicity studies conducted in rats at 15 mg/ kg/ day (this represents approximately 1.5 times the daily human dose [90 mg] based on systemic exposure).
Etoricoxib ma kienx teratoġeniku fl- istudji dwar it- tossiċità riproduttiva li sar fuq firien bi 15 mg/ kg/ kuljum (dan jirrappreżenta madwar 1. 5 drabi d- doża umana kuljum [90 mg] abbażi ta ’ espożizzjoni sistemika).
In rabbits, a treatment related increase in cardiovascular malformations was observed at exposure levels below the clinical exposure at the daily human dose (90 mg).
Fil- fniek, żieda relatata mal- kura f’ malformazzjonijiet kardjovaskulari ġiet osservata f’ livelli ta ’ espożizzjoni taħt l- espożizzjoni klinika fid- doża umana ta ’ kuljum (90 mg).
However no treatment-related external or skeletal foetal
Madankollu, ebda malformazzjoni fetali esterna jew skeletali relatata mal- kura ma ġiet osservata.
In rats and rabbits, there was a dose dependent increase in post implantation loss at exposures greater than or equal to 1.5 times the human exposure (see sections 4.3 and 4.6).
25 F’ firien u fniek, kien hemm żieda dipendenti fuq id- doża f’ telf ta 'wara l- impjantazzjoni f' espożizzjonijiet ikbar minn jew daqs 1. 5 drabi l- espożizzjoni umana (ara sezzjonijiet 4. 3 u 4. 6).
Etoricoxib is excreted in the milk of lactating rats at concentrations approximately two-fold those in plasma.
Etoricoxib jitneħħa fil- ħalib ta ’ firien li jreddgħu f’ konċentrazzjonijiet ta ’ madwar darbtejn dawk fil - plasma.
There was a decrease in pup body weight following exposure of pups to milk from dams administered etoricoxib during lactation.
Kien hemm tnaqqis fil- piż tal- ġisem tal- ferħ wara espożizzjoni tal- frieħ għal ħalib mingħand l- omm mogħtija etoricoxib matul it- treddigħ.
Calcium hydrogen phosphate (anhydrous) Croscarmellose sodium Magnesium stearate Microcrystalline cellulose
Calcium hydrogen phosphate (anhydrous) Croscarmellose sodium Magnesium stearate Microcrystalline cellulose
Tablet coating:
Kisja tal- pillola:
Carnauba wax Lactose monohydrate Hypromellose Titanium dioxide (E171) Triacetin The 30-, 60- and 120-mg tablets also contain indigo carmine lake (E132) and yellow ferric oxide (E172).
Il- pilloli ta ’ 30, 60 u 120 mg ukoll fihom carmine lake indigo (E132) u ferric oxide isfar (E172).
Keep the container tightly closed in order to protect from moisture.
Żomm ir- reċipjent magħluq sewwa sabiex tipproteġi mill- umdità.
30 mg Aluminum/ aluminium blisters in packs containing 7 and 28 tablets.
30 mg Folji ta ’ l- aluminju/ aluminju f’ pakketti li fihom 7 u 28 pillola.
60, 90 and 120 mg Aluminum/ aluminium blisters in packs containing 2, 5, 7, 10, 14, 20, 28, 30, 50, 84, 98 or 100 tablets.
60, 90 u 120 mg Folji ta ’ l- aluminju/ aluminju f’ pakketti li fihom 2, 5, 7, 10, 14, 20, 28, 30, 50, 84, 98 jew 100 pillola.
Aluminum/ aluminium blisters (unit doses) in packs of 50 or 100 tablets.
Folji ta ’ l- aluminju/ aluminju (dożi singoli) f’ pakketti li fihom 50 jew 100 pillola.
White, round, HDPE bottles with a white, polypropylene closure containing 30 tablets and two1-gram desiccant containers or 90 tablets and one1-gram desiccant container.
Fliexken bojod, tondi, HDPE b’ tapp abjad tal- polypropylene li fihom 30 pillola u żewġ reċipjenti dessikanti ta ’ 1 gramma jew 90 pillola u reċipjent dessikant ta ’ 1 gramma.
Not all pack sizes may be marketed.
Jista 'jkun li mhux il- pakketti tad- daqsijiet kollha huma għal skop kummerċjali.
6.6 Special precautions for disposal 25 No special requirements.
Ebda rekwiżit speċjali.
[See Annex 1- To be completed nationally.] {Name and address} {tel} {fax} {e-mail}
[Ara Anness 1 - Għandha timtela fuq livell nazzjonali] {Isem u indirizz} {tel} {fax} {e- mail}.
[To be completed nationally.]
[Għandha timtela fuq livell nazzjonali].
27 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
27 TIKKETTA
< ARCOXIA (see Annex 1) > 30 mg film-coated tablets< ARCOXIA (see Annex 1) > 60 mg film-coated tablets< ARCOXIA (see Annex 1) > 90 mg film-coated tablets < ARCOXIA (see Annex 1) > 120 mg film-coated tablets [See Annex I - To be completed nationally]
< ARCOXIA (ara l- Anness 1) > 30 mg pilloli miksijin b’ rita < ARCOXIA (ara l- Anness 1) > 60 mg pilloli miksijin b’ rita < ARCOXIA (ara l- Anness 1) > 90 mg pilloli miksijin b’ rita < ARCOXIA (ara l- Anness 1) > 120 mg pilloli miksijin b’ rita [Ara l- Anness I – Għandha timtela fuq livell nazzjonali]
Each film coated tablet contains 30 mg etoricoxib.
Kull pillola fiha 30 mg etoricoxib.
Each film coated tablet contains 60 mg etoricoxib.
Kull pillola fiha 60 mg etoricoxib.
Each film coated tablet contains 90 mg etoricoxib.
Kull pillola fiha 90 mg etoricoxib.
Each film coated tablet contains 120 mg etoricoxib.
Kull pillola fiha 120 mg etoricoxib.
Lactose (see leaflet for more information).
Lactose (ara l- fuljett għal aktar tagħrif).
30mg 7 Film-coated tablets 28 Film-coated tablets
30mg 7 Pilloli miksijin b’ rita 28 Pillola miksija b’ rita
60 mg – 90 mg -120mg 2 Film coated tablets 5 Film-coated tablets 7 Film-coated tablets 10 Film-coated tablets 14 Film-coated tablets 20 Film-coated tablets 28 Film-coated tablets 30 Film-coated tablets 50 Film-coated tablets 84 Film-coated tablets 98 Film-coated tablets 100 Film-coated tablets 50 Film-coated tablets (unit dose) 100 Film-coated tablets (unit dose) 30 Film-coated tablets (HDPE bottles) 90 Film-coated tablets (HDPE bottles)
60 mg – 90 mg - 120mg 2 Pilloli miksijin b’ rita 5 Pilloli miksijin b’ rita 7 Pilloli miksijin b’ rita 10 Pilloli miksijin b’ rita 14- il Pillola miksija b’ rita 20 Pillola miksija b’ rita 28 Pillola miksija b’ rita 30 Pillola miksija b’ rita 50 Pillola miksija b’ rita 84 Pillola miksija b’ rita 98 Pillola miksija b’ rita 100 Pillola miksija b’ rita
Bottles Keep the container tightly closed in order to protect from moisture.
Fliexken Żomm ir- reċipjent magħluq sewwa sabiex tilqa ’ mill- umdità.
Blisters Store in original package in order to protect from moisture.
Folji Aħżen fil- pakkett oriġinali sabiex tilqa ’ mill- umdità.
[See Annex I - To be completed nationally]
[Ara Anness I – Li għandha timtela fuq livell nazzjonali] [Għal proċeduri ta ’ referenza]
{Name and Address }< {tel }> < {fax }> < {e-mail }>
{Isem u Indirizz} < {tel} > < {fax} > < {e- mail} >
[To be completed nationally]
[Għandha timtela fuq livell nazzjonali]
GENERAL CLASSIFICATION FOR SUPPLY 29 [To be completed nationally]
[Għandha timtela fuq livell nazzjonali]
30 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
31 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
< ARCOXIA (see Annex 1) > 30 mg film-coated tablets< ARCOXIA (see Annex 1) > 60 mg film-coated tablets< ARCOXIA (see Annex 1) > 90 mg film-coated tablets < ARCOXIA (see Annex 1) > 120 mg film-coated tablets [See Annex I - To be completed nationally]
< ARCOXIA (ara l- Anness 1) > 30 mg pilloli miksijin b’ rita < ARCOXIA (ara l- Anness 1) > 60 mg pilloli miksijin b’ rita < ARCOXIA (ara l- Anness 1) > 90 mg pilloli miksijin b’ rita < ARCOXIA (ara l- Anness 1) > 120 mg pilloli miksijin b’ rita [Ara Anness I – Li għandha timtela fuq livell nazzjonali]
[See Annex I - To be completed nationally]
[Ara Anness I – Li għandha timtela fuq livell nazzjonali]
31 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
32 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
HDPE BOTTLE
FLIXKUN HDPE
< ARCOXIA (see Annex 1) > 60 mg film-coated tablets< ARCOXIA (see Annex 1) > 90 mg film-coated tablets< ARCOXIA (see Annex 1) > 120 mg film-coated tablets [See Annex I - To be completed nationally]
ARCOXIA (ara l- Anness 1) 60 mg pilloli miksijin b’ rita ARCOXIA (ara l- Anness 1) 90 mg pilloli miksijin b’ rita ARCOXIA (ara l- Anness 1) 120 mg pilloli miksijin b’ rita
30 Film coated tablets (HDPE bottles) 90 Film coated tablets (HDPE bottles)
30 pillola miksijin b’ rita (fliexken HDPE) 90 pillola miksijin b’ rita (fliexken HDPE)
33 PACKAGE LEAFLET:
33 FULJETT TA ’ TAGĦRIF
INFORMATION FOR THE USER
34 FULJETT TA ’ TAGĦRIF:
< ARCOXIA > 30 mg film-coated tablets< ARCOXIA > 60 mg film-coated tablets< ARCOXIA > 90 mg film-coated tablets < ARCOXIA > 120 mg film-coated tablets
ARCOXIA 30 mg pilloli miksijin b’ rita ARCOXIA 60 mg pilloli miksijin b’ rita ARCOXIA 90 mg pilloli miksijin b’ rita ARCOXIA 120 mg pilloli miksijin b’ rita
[See Annex I – To be completed nationally]
[Ara l- Anness I – Li għandha timtela fuq livell nazzjonali]
Read all of this leaflet carefully before you start taking this medicine. • Keep this leaflet.
Jekk ikollok aktar mistoqsijiet, staqsi lit- tabib jew lill- ispiżjar tiegħek.
You may need to read it again. • If you have any further questions, ask your doctor or pharmacist. • This medicine has been prescribed for you.
M’ għandekx tgħaddiha lil persuni oħra.
Do not pass it on to others.
Tista ’ tagħmlilhom il - ħsara, anki jekk ikollhom l- istess sintomi bħal tiegħek.
It may harm them, even if their symptoms are the same as yours. • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li m’ humiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għidlit- tabib jew lill- ispiżjar tiegħek.
What< ARCOXIA > is and what it is used for 2.
X’ inhu < ARCOXIA > u għalxiex jintuża 2.
Before you take< ARCOXIA > 3.
Qabel ma tieħu < ARCOXIA > 3.
How to take< ARCOXIB > 4.
Kif għandek tieħu < ARCOXIA > 4.
How to store< ARCOXIA > 6.
Kif taħżen < ARCOXIA > 6.
WHAT< ARCOXIA > IS AND WHAT IT IS USED FOR
X' INHU < ARCOXIA > U GĦALXIEX JINTUŻA
These belong to a family of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). • < ARCOXIA > helps to reduce the pain and swelling (inflammation) in the joints and muscles of people with osteoarthritis, rheumatoid arthritis, ankylosing spondylitis and gout.
• < ARCOXIA > huwa wieħed minn grupp ta ’ mediċini msejħa inibituri selettivi cox- 2. dawn jappartjenu għal familja ta ’ mediċini msejħa mediċini anti- infjammatorji mhux sterojdi (nsaids). • < ARCOXIA > Etoricoxib jgħin biex inaqqas l- uġigħ u n- nefħa (infjammazzjoni) fil- ġogi u l - muskoli ta ’ persuni li jbatu bl- osteoartrite, l- artrite rewmatojde, ankylosing spondylitis u l- gotta.
What is osteoarthritis?
X’ inhi l- osteoartrite?
Osteoarthritis is a disease of the joints.
Osteoartrite hija marda tal- ġogi.
It results from the gradual breakdown of cartilage that cushions the ends of the bones.
Din tirriżulta mill- kollass gradwali tal- qarquċa li tipproteġi t- truf ta ’ l- għadam.
This causes swelling (inflammation), pain, tenderness, stiffness and disability.
Din tikkawża nefħa (infjammazzjoni), uġigħ, tenerezza, ebusija tal- ġisem u diżabilità.
What is rheumatoid arthritis?
X’ inhi l- artrite rewmatojde?
Rheumatoid arthritis is a long term inflammatory disease of the joints.
L- artrite rewmatojde hija marda infjammatorja tal- ġogi għal perjodu ta ’ żmien twil.
It causes pain, stiffness, swelling, and increasing loss of movement in the joints it affects.
Din tikkawża uġigħ, ebusija tal- ġisem, nefħa, u żieda fit- telf tal- moviment fil- ġogi li taffettwa.
It may also cause inflammation in other areas of the body.
Tista ’ tikkawża wkoll infjammazzjoni f’ partijiet oħra tal- ġisem.
What is gout?
X’ inhi l- gotta?
Gout is a disease of sudden, recurring attacks of very painful inflammation and redness in the joints.
Il- gotta hija marda ta ’ attakki għal għarrieda u rikorrenti ta 'infjammazzjoni li ġġib uġigħ kbir u ħmura fil- ġogi.
It is caused by deposits of mineral crystals in the joint.
Hija kkawżata minn depożiti ta 'kristalli minerali fil- ġog.
What is ankylosing spondylitis?
X’ inhi ankylosing spondylitis?
Ankylosing spondylitis is an inflammatory disease of the spine and large joints.
Ankylosing spondylitis hija marda infjammatorja ta ’ l- ispina u tal- ġogi l- kbar.
BEFORE YOU TAKE< ARCOXIA >
QABEL TIEĦU < ARCOXIA >
Do not take< ARCOXIA >: • if you are allergic (hypersensitive) to etoricoxib or any of the other ingredients of < ARCOXIA > (see Further information, section 6) • if you are allergic to non-steroidal anti-inflammatory drugs (NSAIDs), including aspirin and COX-2 inhibitors (see Possible Side Effects, section 4) • if you have a current stomach ulcer or bleeding in your stomach or intestines • if you have serious liver disease • if you have serious kidney disease • if you are or could be pregnant or are breast-feeding (see ‘Pregnancy and breast feeding’) • if you are under 16 years of age • if you have inflammatory bowel disease, such as Crohn’s Disease, Ulcerative Colitis, or Colitis • if your doctor has diagnosed heart problems including heart failure (moderate or severe types), angina (chest pain) or if you have had a heart attack, bypass surgery, peripheral arterial disease (poor circulation in legs or feet due to narrow or blocked arteries), or any kind of stroke (including mini- stroke, transient ischaemic attack or TIA).
Tiħux < ARCOXIA >: • jekk inti allerġiku (tbati minn sensittività eċċessiva) għal etoricoxib jew għal xi sustanza oħra ta ’ < ARCOXIA > (ara Aktar tagħrif, sezzjoni 6) • jekk inti allerġiku għal mediċini anti- infjammatorji mhux sterojdi (NSAIDs), inkluż aspirina u inibituri COX- 2 (ara Effetti Sekondarji Possibbli, sezzjoni 4) • jekk bħalissa għandek ulċera fl- istonku jew fsada fl- intestini jew fl- istonku tiegħek • jekk għandek marda serja fil- fwied • jekk għandek marda serja fil- kliewi • jekk inti tqila jew taħseb li tista ’ tkun tqila jew inkella qegħda tredda ’ (ara ‘ Tqala u treddigħ ’) • jekk inti għandek inqas minn 16- il sena • jekk għandek marda infjammatorja ta 'l- imsaren, bħall- Marda ta ’ Crohn, Kolite Ulċerattiva jew Kolite • jekk it- tabib tiegħek ikun iddijanjostika problemi tal- qalb inkluż kollass tal- qalb (tipi moderati jew severi), anġina (uġigħ fis- sider) jew jekk kellek attakk tal- qalb, kirurġija tal- bypass, marda arterjali periferali (ċirkolazzjoni batuta fir- riġlejn jew fis- saqajn minħabba arterji dojoq jew imblokkati), jew kwalunkwe tip ta' puplesija (inkluż mini- puplesija, attakk iskemiku temporanju jew TIA).
Etoricoxib may slightly increase your risk of heart attack and stroke and this is why it should not be used in those who have already had heart problems or stroke • if you have high blood pressure that has not been controlled by treatment (check with your doctor or nurse if you are not sure whether your blood pressure is adequately controlled)
Etoricoxib jista ’ jżid kemmxejn ir- riskju ta ’ attakk tal- qalb jew ta ’ puplesija tiegħek u din hija r- raġuni l- għala ma għandux jintuża f’ dawk li diġà kellhom problemi tal- qalb jew puplesija • jekk għandek pressjoni tad- demm għolja li ma ġietx ikkontrollata bit- trattament (ara mat- tabib tiegħek jew man- ners tiegħek jekk m’ intix ċert/ a jekk il- pressjoni tad- demm tiegħek hijiex ikkontrollata b’ mod adegwat)
If you think any of these are relevant to you, do not take the tablets until you have consulted your doctor.
Jekk taħseb li xi punt minn dawn t’ hawn fuq huwa relevanti għalik, tiħux il- pilloli qabel ma tkun ikkonsultajt mat- tabib tiegħek.
Take special care with< ARCOXIA > < ARCOXIA > may not be suitable for you, or you may need to be monitored regularly while taking it if any of the following apply to you:
Oqgħod attent ħafna b '< ARCOXIA > < ARCOXIA > jista ’ ma jkunx tajjeb għalik, jew jista' jkun hemm bżonn li inti tkun immonitorjat regolarment meta tkun qed tieħdu jekk xi punt minn dawn li ġejjin japplika għalik:
These can increase your risk of heart disease.
• Għandek storja ta ’ fsada fl- istonku jew ta ’ ulċeri. • Jekk inti de- idrat, per eżempju minn attakk ta ’ rimettar jew dijarrea. • Għandek nefħa minħabba żamma ta ’ fluwidi. • Għandek storja ta ’ kollass tal- qalb, attack tal- qalb jew xi forma oħra ta ’ mard tal- qalb. • Għandek storja ta ’ puplesija jew ta ’ mini puplesija. • Għandek storja ta ’ pressjoni għolja tad- demm. < ARCOXIA > jista ’ jżid il- pressjoni tad- demm f’ xi nies, b’ mod speċjali f’ dożi għoljin, u t- tabib tiegħek ikun irid jara l- pressjoni tad- demm tiegħek minn żmien għal żmien. • Għandek xi storja ta ’ mard tal- fwied jew tal- kliewi. • Qed tiġi kkurat/ a għal infezzjoni. < ARCOXIA > jista ’ jaħbi deni, li huwa sinjal ta ’ infezzjoni. • Inti mara li tixtieq tinqabad tqila. • Inti anzjan/ a (jiġifieri għandek aktar minn 65 sena). • Għandek id- dijabete, kolesterol għoli, jew tpejjep Dawn jistgħu jżidu r- riskju ta ’ mard tal- qalb tiegħek.
If you are not sure if any of the above apply to you, talk to your doctor before taking< ARCOXIA > to see if this medicine is suitable for you.
Jekk m’ intix ċert jekk xi punt minn dawn t’ hawn fuq japplikax għalik, kellem lit- tabib tiegħek qabel tieħu < ARCOXIA > biex tara jekk din il- mediċina hijiex tajba għalik.
< ARCOXIA > works equally well in older and younger adult patients.
< ARCOXIA > jaħdem tajjeb kemm fuq pazjenti anzjani kif ukoll fuq pazjenti adulti iżgħar fl- età.
If you are elderly (i. e., over 65 years of age), your doctor will want to appropriately keep a check on you.
Jekk inti anzjan/ a (jiġifieri għandek aktar minn 65 sena), it- tabib tiegħek ikun irid jiċċekjak b' mod adegwat.
No dosage adjustment is necessary for elderly patients.
Ebda aġġustament fid- doża ma huwa meħtieġ għal pazjenti anzjani.
Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
36 Meta tuża medicini oħra Jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek jekk qed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
35 In particular if you are taking any of the following medicines, your doctor may want to monitor you to check that your medicines are working properly, once you start taking< ARCOXIA >:
B’ mod partikolari, jekk qed tieħu xi mediċini minn dawn li ġejjin, it- tabib tiegħek ikun irid jimmonitorjak sabiex jara li l- mediċini tiegħek qegħdin jaħdmu sew, ladarba tibda tieħu < ARCOXIA >:
• medicines that thin your blood (anticoagulants), such as warfarin • rifampicin (an antibiotic) • methotrexate (a drug used for suppressing the immune system, and often used in rheumatoid arthritis) • medicines used to help control high blood pressure and heart failure called ACE inhibitors and angiotensin receptor blockers, examples include enalapril and ramipril, and losartan and valsartan • lithium (a medicine used to treat some types of depression) • diuretics (water tablets) • ciclosporin or tacrolimus (drugs used for suppressing the immune system) • digoxin (a medicine for heart failure and irregular heart rhythm) • minoxidil (a drug used to treat high blood pressure) • salbutamol tablets or oral solution (a medicine for asthma) • birth control pills • hormone replacement therapy • aspirin, the risk of stomach ulcers is greater if you take< ARCOXIA > with aspirin. - < ARCOXIA > can be taken with low-dose aspirin.
• mediċini li jraqqu d- demm tiegħek (antikoagulanti), bħall- warfarina • rifampicin (antibijotiku) • methotrexate (mediċina użata għat- trażżin tas- sistema immunitarja, u spiss użata f’ artrite rewmatojde) • mediċini użati biex jgħinu jikkontrollaw pressjoni tad- demm għolja u indeboliment tal- qalb imsejħin inibituri ACE u imblokkaturi ta ’ riċetturi angiotensin, eżempji jinkludu enalapril u ramipril, u losartan u valsartan • litju (mediċina użata sabiex tikkura xi tipi ta ’ dipressjoni) • dijuretiċi (pilloli ta ’ l- ilma) • ciclosporin jew tacrolimus (mediċini użati għat- trażżin tas- sistema immunitarja) • digoxin (mediċina għall- kollass tal- qalb u għal ritmu irregolari tal- qalb) • minoxidil (mediċina wżata biex tikkura pressjoni tad- demm għolja) • pilloli salbutamol jew soluzzjoni orali (mediċina għall- ażżma) • pilloli ta ’ kontroll tat- twelid • terapija ta ’ sostituzzjoni ta ’ l- ormoni • aspirina, ir- riskju ta ’ ulċeri fl- istonku huwa ikbar jekk tieħu < ARCOXIA > ma ’ l- aspirina.
If you are currently taking low-dose aspirin to prevent heart attacks or stroke, you should not stop taking aspirin until you talk to your doctor -do not take high dose aspirin or other anti-inflammatory medicines while taking< ARCOXIA >
Jekk fil- preżent qed tieħu aspirina ta ’ doża baxxa biex timpedixxi attakki tal- qalb jew puplesija, ma għandekx tieqaf tieħu aspirina sakemm tkellem lit- tabib tiegħek
Pregnancy and breast-feeding< ARCOXIA > tablets must not be taken during pregnancy.
Tqala u treddigħ Il- pilloli ta ’ < ARCOXIA > ma għandhomx jintużaw waqt tqala.
If you are pregnant or think you could be pregnant, or if you are planning to become pregnant, do not take the tablets.
Jekk inti tqila jew taħseb li inti tqila, jew jekk qegħda tippjana li ssir tqila, tiħux il- pilloli.
If you become pregnant, stop taking the tablets and consult your doctor.
Jekk toħroġ tqila, waqqaf il- pilloli u kellem lit - tabib tiegħek.
Consult your doctor if you are unsure or need more advice.
Kellem lit- tabib tiegħek jekk m’ intix ċerta jew jekk taħseb li għandek bżonn aktar parir.
It is not known if< ARCOXIA > is excreted in human milk.
Mhuwiex magħruf jekk < ARCOXIA > joħroġx fil- ħalib uman.
If you are breast-feeding, or planning to breast- feed, consult your doctor before taking< ARCOXIA >.
Jekk qegħda tredda ’, jew jekk qegħda tippjana li tredda ’, ikkonsulta mat- tabib tiegħek qabel tieħu < ARCOXIA >.
If you are using< ARCOXIA >, you must not breast- feed.
Jekk qegħda tuża < ARCOXIA >, ma għandekx tredda ’.
Driving and using machines Dizziness and sleepiness have been reported in some patients taking< ARCOXIA >.
Sewqan u tħaddim ta ’ magni Sturdament u ħedla ġew irrapportati f’ xi pazjenti li kienu qegħdin jieħdu < ARCOXIA >.
Do not drive if you experience dizziness or sleepiness.
Issuqx jekk tesperjenza sturdament jew ħedla.
Do not use any tools or machines if you experience dizziness or sleepiness.
Tużax għodda jew magni jekk tesperjenza sturdament jew ħedla.
Important information about some of the ingredients of< ARCOXIA > < ARCOXIA > contains lactose.
Tagħrif importanti dwar xi wħud mis- sustanzi ta '< ARCOXIA > < ARCOXIA > fih lactose.
If you have been told by your doctor that you are unable to tolerate some sugars, contact your doctor before taking this medicinal product.
Jekk it- tabib tiegħek qallek li inti ma tittollerax xi zokkor, kellem lit- tabib tiegħek qabel tieħu dan il- prodott mediċinali.
HOW TO TAKE< ARCOXIA >
KIF TIEĦU < ARCOXIA >
Always take< ARCOXIA > exactly as your doctor has told you.
Dejjem għandek tieħu < ARCOXIA > eżatt kif jgħidlek it- tabib tiegħek.
You should check with your doctor or pharmacist if you are not sure.
Għandek tiċċekkja mat- tabib jew ma ’ l- ispiżjar tiegħek jekk ma tkunx ċert/ a.
< ARCOXIA > Tablets should not be taken by children or adolescents under 16 years of age.
Il- Pilloli ta ’ < ARCOXIA > ma għandhomx jittieħdu mit- tfal jew mill- adoloxxenti li għandhom inqas minn 16- il sena.
Take< ARCOXIA > Tablets by mouth once a day. < ARCOXIA > can be taken with or without food.
Ħu l- Pilloli ta ’ < ARCOXIA > mill- ħalq darba kuljum. < ARCOXIA > jista ’ jittieħed bi jew mingħajr ikel.
Do not take more than the recommended dose for your condition.
Tiħux aktar mid- doża rakkomandata għall- kundizzjoni tiegħek.
Your doctor will want to discuss your treatment from time to time.
It- tabib tiegħek ikun irid jiddiskuti l - kura tiegħek minn żmien għall- ieħor.
It is important that you use the lowest dose that controls your pain and you should not take< ARCOXIA > for longer than necessary.
Huwa importanti li tuża l- iżgħar doża li tikkontrolla l- uġigħ tiegħek u ma għandekx tieħu < ARCOXIA > għal perjodu ta 'żmien itwali milli jkun hemm bżonn.
This is because the risk of heart attacks and strokes might increase after prolonged treatment, especially with high doses.
Dan minħabba li r- riskji ta ’ attakki tal- qalb u ta ’ puplesiji jistgħu jiżdiedu wara kura prolungata, b’ mod speċjali b’ dożi għoljin.
36 Osteoarthritis The recommended dose is 30 mg once a day, increase to a maximum of 60 mg once a day if needed.
Osteoartrite Id- doża rakkomandata hija 30 mg darba kuljum, miżjuda għal massimu ta ’ 60 mg darba kuljum jekk ikun hemm bżonn.
Rheumatoid arthritis The recommended dose is 90 mg once a day.
Artrite rewmatojde Id- doża rakkomandata hija 90 mg darba kuljum.
Gout The recommended dose is 120 mg once a day which should only be used for the acute painful period, limited to a maximum of 8 days treatment.
Gotta Id- doża rrakkomandata hija 120 mg darba kuljum li għandha tintuża biss għall- perjodu ta ’ uġigħ akut, limitat għal massimu ta ’ 8 ijiem kura.
Ankylosing spondylitis The recommended dose is 90 mg once a day.
Ankylosing spondylitis Id- doża rakkomandata hija 90 mg kuljum.
People with liver problems • If you have mild liver disease, you should not take more than 60 mg a day. • If you have moderate liver disease, you should not take more than 60 mg every other day or 30 mg a day.
Nies bi problemi tal- fwied • Jekk għandek marda tal- fwied ħafifa, ma għandekx tieħu aktar minn 60 mg kuljum. • Jekk għandek marda tal- fwied moderata, ma għandekx tieħu aktar minn 60 mg kuljum darba iva u darba le jew 30 mg kuljum.
If you take more< ARCOXIA > than you should You should never take more tablets than the doctor recommends.
Jekk tuża aktar < ARCOXIA > milli suppost Qatt ma għandek tieħu iktar pilloli milli jgħidlek it- tabib.
If you do take too many< ARCOXIA > tablets, you should seek medical attention immediately.
Jekk tieħu wisq Pilloli < ARCOXIA >, għandek tmur tfittex attenzjoni medika minnufih.
If you forget to take< ARCOXIA > It is important to take< ARCOXIA > as your doctor has prescribed.
Jekk tinsa tieħu < ARCOXIA > Dejjem għandek tieħu < ARCOXIA > skond il- parir tat- tabib.
If you miss a dose, just resume your usual schedule the following day.
Jekk tinsa tieħu doża, kull ma għandek tagħmel huwa li l- għada tkompli bl- iskeda normali tiegħek.
Do not take a double dose to make up for the forgotten tablet.
Tiħux doża doppja biex tpatti għal kull pillola li tkun insejt tieħu.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Jekk għandek aktar mistoqsijiet dwar l- użu ta ’ dan il- prodott, staqsi, lit- tabib jew lill- ispiżjar tiegħek.
Like all medicines ,< ARCOXIA > can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, < ARCOXIA > jista ’ jkollu effetti mhux mixtieqa, għalkemm ma jidhrux fuq kulħadd.
If you develop any of these signs you should stop< ARCOXIA > and talk to your doctor immediately: • shortness of breath, chest pains, or ankle swelling appear or if they get worse • yellowing of the skin and eyes (jaundice) – these are signs of liver problems • severe or continual stomach pain or your stools become black • an allergic reaction- which can include skin problems such as ulcers or blistering, or swelling of the face, lips, tongue, or throat which may cause difficulty in breathing
38 Jekk tiżviluppa kwalunkwe sinjal minn dawn, għandek tieqaf tieħu < ARCOXIA > u għandek tkellem lit- tabib tiegħek minnufih: • jekk tesperjenza qtugħ ta ’ nifs, uġigħ fis- sider, jew nefħa fl- għekiesi jew jekk dawn imorru għall- agħar • il- ġilda u l- għajnejn jisfaru (suffejra) – dawn huma sinjali ta ’ problemi fil- fwied • uġigħ sever jew kontinwu fl- istonku jew jekk l- ippurgar tiegħek isir iswed • reazzjoni allerġika – li tista ’ tinkludi problem ital- ġilda bħal ulċeri jew infafet, jew nefħa tal - wiċċ, xofftejn, ilsien, jew gerżuma li tista ’ tikkawża diffikultà fit- teħid tan- nifs
The following side effects can occur during treatment with< ARCOXIA >:
L- effetti sekondarji li ġejjin jistgħu jseħħu matul trattament b ’ < ARCOXIA >:
Common (occurring in greater than 1 out of 100 and less than 1 out of 10 people) Weakness and fatigue, dizziness, headache, flu-like illness, diarrhoea, wind, nausea, indigestion (dyspepsia), stomach pain or discomfort, heartburn, changes in blood tests related to your liver, swelling of the legs and/ or feet due to fluid retention (oedema), increased blood pressure, palpitations, bruising.
Komuni (li jseħħu f’ aktar minn persuna 1 minn kull 100 u f’ inqas minn persuna 1 minn kull 10) Dgħjufija u għejja, sturdament, uġigħ ta ’ ras, mard simili għal dak ta ’ l- influwenza, dijarrea, gass, nawseja, indiġestjoni (dispepsija), uġigħ jew skumdità fl- istonku, ħruq ta ’ stonku, tibdil fit- testijiet tad- demm relatat mal- fwied tiegħek, nefħa fir- riġlejn u/ jew fis- saqajn dovuta għal żamma ta ’ fluwidu (edema), pressjoni tad- demm ogħla, palpitazzjonijiet, tbenġil.
Uncommon (occurring in greater than 1 out of 1000 and less than 1 out of 100 people) Stomach or bowel bloating, chest pain, heart failure, heart attack, stroke, mini-stroke (transient ischaemic attack), abnormal heart rhythm (atrial fibrillation), upper respiratory infection, high levels of potassium in your blood, changes in blood or urine tests relating to your kidney, changes in your bowel habits including constipation, dry mouth, mouth ulcers, taste alteration, gastroenteritis, gastritis, stomach ulcer, being sick (vomiting), irritable bowel syndrome, inflammation of the esophagus, blurred vision, eye irritation and redness, nose bleed, ringing in the ears, vertigo, appetite increases or decreases, weight gain, muscle cramp/ spasm, muscle pain/ stiffness, inability to sleep, sleepiness, numbness or tingling, anxiety, depression, 37 decreases in mental sharpness, breathlessness, cough, swelling of the face, flushing, skin rash or itchy skin, urinary tract infection.
Mhux komuni (li jseħħu f’ aktar minn persuna 1 minn kull 1000 u f’ inqas minn persuna 1 minn kull 100) Nefħa fl- istonku jew fl- imsaren, uġigħ fis- sider, kollass tal- qalb, attakk tal- qalb, puplesija, puplesija ħafifa (attakk iskemiku temporanju), rittmu tal- qalb anormali (fibrillazzjoni atrijali), infezzjoni fil - parti respiratorja ta ’ fuq, livelli għoljin ta ’ potassju f’ demmek, tibdil fit- testijiet tad- demm u ta ’ l - awrina relatat mal- kliewi tiegħek, tibdil fil- mod kif jaħdmu l- imsaren inkluż stitikezza, ħalq xott, ulċeri tal- ħalq, tibdil fit- togħma, gastroenterite, gastrite, ulċera fl- istonku, tħossok ma tiflaħx (rimettar), is- sindrome ta ’ l- imsaren irritabbli, infjammazjoni ta ’ l- esofagu, viżta mċajpra, irritazzjoni u ħmura ta ’ l- għajn, fsada fl- imnieħer, ċempil fil- widnejn, vertiġini, żieda jew tnaqqis fl- aptit, żieda fil- piż, bugħawwiġ/ spażmi fil- muskoli, uġigħ/ ebusija fil- muskoli, inabilità biex torqod, ħedla, tirżih jew tagħrix, ansjetà, dipressjoni, tnaqqis fil- prontezza mentali, nuqqas ta 'nifs, sogħla, nefħa tal- wiċċ, ħmura fil- wiċċ, raxx tal- ġilda jew ħakk fil- ġilda, infezzjoni fil- passaġġ urinarju.
Rare (occurring in greater than 1 out of 10,000 and less than 1 out of 1000 people) Low blood levels of sodium.
Komuni (li jseħħu f’ aktar minn persuna 1 minn kull 10, 000 u f’ inqas minn persuna 1 minn kull 1000) Livelli baxxi fid- demm ta ’ sodju.
Very Rare (occurring in less than 1 out of 10,000 people) Allergic reactions (which may be serious enough to require immediate medical attention) including hives, swelling of the face, lips, tongue, and/ or throat which may cause difficulty in breathing or swallowing, bronchospasm (wheezing or shortness of breath), severe skin reactions, inflammation of the stomach lining or stomach ulcers that can become serious and may lead to bleeding, liver problems, serious kidney problems, severe increase in blood pressure, confusion, seeing, feeling or hearing things that are not there (hallucinations).
Rari Ħafna (li jseħħu f’ inqas minn persuna 1 minn kull 10, 000) Reazzjonijiet allerġiċi (li jistgħu jkunu serji biżżejjed biex ikunu jeħtieġu attenzjoni medika immedjata) inkluż ħorriqija, nefħa tal- wiċċ, xofftejn, ilsien u/ jew gerżuma li jistgħu jikkawżaw diffikultà fit- teħid tan- nifs jew biex wieħed jibla ’, bronkospażmi (tħarħir jew qtugħ ta ’ nifs), reazzjonijiet severi tal- ġilda, infjammazzjoni ta ’ l- inforra ta ’ l- istonku jew ulċeri fl- istonku li jistgħu jsiru serji u jistgħu jwasslu għal fsada, problemi fil- fwied, problemi serji fil- kliewi, żieda severa fil - pressjoni tad- demm, konfużjoni, tara, tħoss u tisma ’ affarijiet li mhumiex hemm (alluċinazzjonijiet).
HOW TO STORE< ARCOXIA >
KIF TAĦŻEN < ARCOXIA >
Do not use< ARCOXIA > after the expiry date which is stated on the pack.
Tużax < ARCOXIA > wara d- data ta ’ skadenza li tidher fuq il- pakkett.
Medicines should not be disposed of via wastewater or household waste.
39 Il- mediċini m’ għandhomx jintremew ma ’ l- ilma tad- dranaġġ jew ma ’ l- iskart domestiku.
FURTHER INFORMATION
6 GĦAL AKTAR TAGĦRIF
What< ARCOXIA > contains
X’ fih < ARCOXIA >
• The active substance is etoricoxib.
• Is- sustanza attiva hija etoricoxib.
Each film coated tablet contains 30, 60, 90 or 120 mg of etoricoxib.
Kull pillola miksija b’ rita fiha 30, 60, 90 jew 120 mg ta ’ etoricoxib.
• The other ingredients are:
• Is- sustanzi l- oħrajn huma:
Core: calcium hydrogen phosphate (anhydrous), croscarmellose sodium, magnesium stearate, microcrystalline cellulose.
Qalba: calcium hydrogen phosphate (anhydrous), croscarmellose sodium, magnesium stearate, microcrystalline cellulose.
Tablet coating: carnauba wax, lactose monohydrate, hypromellose, titanium dioxide (E171), triacetin.
Il- kisja tal- pillola: carnauba wax, lactose monohydrate, hypromellose, titanium dioxide (E171), triacetin.
The 30-, 60- and 120-mg tablets also contain yellow ferric oxide (E172, colouring agent) and indigo carmine lake (E132, colouring agent).
Il- pilloli ta ’ 30 -, 60 - u 120 - mg fihom ukoll ferric oxide isfar (E172, kolorant) u carmine lake indigo (E132, kolorant).
What< ARCOXIA > looks like and contents of the pack
Id- dehra ta '< ARCOXIA > u l- kontenut tal- pakkett
< ARCOXIA > Tablets are available in four strengths:
Il- Pilloli ta ’ < ARCOXIA > jiġu f’ erba ’ qawwiet:
30 mg blue-green, apple-shaped, biconvex film coated tablets marked ‘ ACX 30’ on one side and ‘ 101’ on the other.
30 mg pilolli miksijin b’ rita, ġejjin għat- tond miż- żewġ naħat, f’ għamla ta ’ tuffieħa, blu- ħodor immarkati ‘ ACX 30 ’ fuq naħa u b ’ ‘ 101 ’ fuq in- naħa l- oħra.
38 60 mg dark green, apple-shaped, biconvex film coated tablets marked ‘ ARCOXIA 60’ on one side and ‘ 200’ on the other.
60 mg pilolli miksijin b’ rita ġejjin għat- tond miż- żewġ naħat, f’ għamla ta ’ tuffieħa, blu- ħodor immarkati ‘ ARCOXIA 60 ’ fuq naħa u b ’ ‘ 200 ’ fuq in- naħa l- oħra.
90 mg white, apple-shaped, biconvex film coated tablets marked ‘ ARCOXIA 90’ on one side and ‘ 202’ on the other.
90 mg pilolli miksijin b’ rita, ġejjin għat- tond miż- żewġ naħat, f’ għamla ta ’ tuffieħa, blu- ħodor immarkati ‘ ARCOXIA 90 ’ fuq naħa u b ’ ‘ 202 ’ fuq in- naħa l- oħra.
120 mg pale-green, apple-shaped, biconvex film coated tablets marked ‘ ARCOXIA 120’ on one side and ‘ 204’ on the other.
120 mg pilolli miksijin b’ rita ġejjin għat- tond miż- żewġ naħat, f’ għamla ta ’ tuffieħa, blu- ħodor immarkati ‘ ARCOXIA 120 ’ fuq naħa u b ’ ‘ 204 ’ fuq in- naħa l- oħra.
Pack sizes of 7 and 28 tablets in blisters.
Daqsijiet tal- pakkett ta ’ 7 u 28 pillola f’ folji.
Pack sizes of 2, 5, 7, 10, 14, 20, 28, 30, 50, 84, 98 or 100 tablets in blisters; or 30 and 90 tablets in bottles.
60, 90 u 120 mg Daqsijiet tal- pakketti ta ’ 2, 5, 7, 10, 14, 20, 28, 30, 50, 84, 98 jew 100 pillola f’ folji; jew 30 u 90 pillola fi fliexken.
Marketing Authorisation Holder and Manufacturer [See Annex 1-To be filled in nationally] {Name and address} {tel} {fax} {e-mail}
Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq u Manifattur [Ara l- Anness 1- Li għandha timtela fuq livell nazzjonali] {Isem u indirizz} {tel} {fax} {e- mail}
This medicinal product is authorized in the Member States of the EEA under the following names:
40 Dan il- prodott mediċinali huwa awtorizzat fl- Istati Membri taż- ŻEE bl- ismijiet li ġejjin:
Austria Belgium Bulgaria Czech Rep.
L- Awstrija
Cyprus Denmark Estonia Finland France Germany Greece Hungary Iceland Ireland Italy Latvia Lithuania Luxembourg Malta Netherlands Norway Poland Portugal Romania Slovakia Slovenia Spain
Arcoxia 30 mg, 60 mg, 90 mg, 120 mg- Filmtabletten Auxib 30 mg, 60 mg, 90, 120 mg- Filmtabletten
Arcoxia 30 mg, 60 mg, 90 mg, 120 mg-Filmtabletten Arcoxia 30 mg, 60 mg, 90 mg, 120 mg, comprimés pelliculés ARCOXIA ARCOXIA 30 mg, 60 mg, 90 mg, 120 mg Arcoxia 30, 60, 90, 120 mg Arcoxia Arcoxia Arcoxia 30, 60, 90 ja 120 mg tabletti, kalvopäällysteinen Arcoxia 30 mg, comprimé pelliculé ARCOXIA 30/ 60/ 90/ 120 mg Filmtabletten ARCOXIA 30mg, 60mg, 90mg,120mg film-coated tablets Arcoxia 30 mg, 60 mg, 90 mg, 120 mg filmtabletta Arcoxia Arcoxia 30, 60, 90 or 120 mg film-coated tablets Arcoxia 30, 60, 90, 120 mg compresse rivestite con film Arcoxia 30 mg, 60 mg, 90 mg un 120 mg apvalkotā s tablets Arcoxia 30, 60, 90, 120 mg plė vele dengtos tabletė s Arcoxia 30 mg, 60 mg, 90 mg, 120 mg, comprimés pelliculés ARCOXIA 30, 60, 90 or 120 mg film-coated tablets Arcoxia 30 mg, 60 mg, 90 mg, 120 mg Arcoxia ARCOXIA 30 mg, 60 mg, 90 mg, 120 mg tabletki powlekane ARCOXIA 30 mg, 60 mg, 90 mg, 120 mg comprimidos revestidos por película ARCOXIA 60 mg, 90 mg, 120 mg, comprimate filmate ARCOXIA 30 mg, 60 mg, 90 mg, 120 mg Arcoxia 30/ 60/ 90/ 120 mg filmsko oblož ene tablete Arcoxia 30, 60, 90 y 120 mg comprimidos recubiertos con película
Il- Belġju
39
Arcoxia 30 mg, 60 mg, 90 mg, 120 mg, comprimés pelliculés Ranacox 30 mg, 60 mg, 90 mg, 120 mg, comprimés pelliculés
Sweden United Kingdom
Il- Bulgarija Ir- Rep.
Arcoxia 30 mg, 60 mg, 90 mg och 120 mg filmdragerade tabletter ARCOXIA 30, 60, 90 or 120 mg film-coated tablets
ARCOXIA ARCOXIA 30 mg, 60 mg, 90 mg, 120 mg Arcoxia 30, 60, 90, 120 mg Arcoxia Arcoxia Arcoxia 30, 60, 90 ja 120 mg tabletti, kalvopäällysteinen Turox 30, 60, 90 ja 120 mg tabletti, kalvopäällysteinen
This leaflet was last approved in (MM/ YYYY).
Ir- Rumanija Is- Slovakja Is- Slovenja Spanja L- Iżvezja Ir- Renju Unit
40 ANNEX IV
ARCOXIA 60 mg, 90 mg, 120 mg, comprimate filmate ARCOXIA 30 mg, 60 mg, 90 mg, 120 mg Arcoxia 30/ 60/ 90/ 120 mg filmsko obložene tablete Arcoxia 30, 60, 90 y 120 mg comprimidos recubiertos con película Arcoxia 30 mg, 60 mg, 90 mg och 120 mg filmdragerade tabletter ARCOXIA 30, 60, 90 or 120 mg film- coated tablets
CONDITIONS OF THE MARKETING AUTHORISATION
Dan il- fuljett kien approvat l- aħħar f '(XX/ SSSS).
41 CONDITIONS OF THE MARKETING AUTHORISATION
41 ANNESS IV
who prescribe etoricoxib according to national practice.
KUNDIZZJONIJIET TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
42
42 KUNDIZZJONJIET TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
London, 23 October 2008 EMEA/ 438258/ 2008
Londra, 23 ta ’ Ottubru 2008 EMEA/ CHMP/ 619562/ 2008
COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 6 (12) REFERRAL
KUMITAT GĦALL- PRODOTTI MEDIĊINALI GĦALL- UŻU MILL- BNIEDEM (CHMP) OPINJONI WARA REFERENZA GĦALL- ARTIKOLU 6( 12)
International non-proprietary name (INN): etoricoxib
Denominazzjoni Komuni Internazzjonali (DKI): etoricoxib
BACKGROUND INFORMATION *
INFORMAZZJONI ĠENERALI *
Etoricoxib is a selective inhibitor of COX-2 (cyclooxygenase 2) indicated in the symptomatic relief of osteoarthritis (OA, 30-60mg once daily (od)), rheumatoid arthritis (RA, 90mg od) and the pain and signs of inflammation associated with acute gouty arthritis (120mg od).
Etoricoxib huwa inibitur selettiv ta ’ COX- 2 (ċiklossiġenażi 2) indikat fit- taffija tas- sintomi ta ’ osteoartrite (OA, 30- 60 mg darba kuljum (od)), artrite rewmatojde (RA, 90 mg od) u l- uġigħ u s- sinjali ta ’ infjammazzjoni assoċjati ma ’ artrite gottuża akuta (120 mg od).
This referral procedure relates to a request for arbitration concerning a type II variation for a new indication to include treatment of ankylosing spondylitis (AS), at a recommended daily dose of 90mg.
Din il- proċedura ta ’ referenza tirrigwarda talba għal arbitraġġ dwar varjazzjoni tat- tip II sabiex indikazzjoni ġdida tkun tinkludi trattament ta ’ spondilite ankilosanti (AS), f’ doża rakkomandata ta ’ 90 mg.
At the end of the mutual recognition procedure, there was a discrepancy between different European Union (EU) Member States regarding the safety of etoricoxib at the 90mg dose in the new proposed indication.
Fi tmiem il- proċedura ta ’ rikonoxximent reċiproku, diversi Stati Membri tal- Unjoni Ewropea (UE) ma qablux rigward is- sigurtà ta ’ etoricoxib fid- doża ta ’ 90 mg fl- indikazzjoni l- ġdida proposta.
As these concerns were not resolved during the course of the procedure, a notification of an official referral for arbitration under Article 6(12) of Commission Regulation EC No 1084/ 2003 to the CHMP was made by France on 19 September 2007.
Peress li dan it- tħassib ma ġiex riżolt tul il- proċedura, Franza għamlet notifika ta ’ referenza ta ’ arbitraġġ uffiċjali skont l- Artikolu 6( 12) tar- Regolament tal- Kummissjoni KE Nru 1084/ 2003 lis- CHMP fid - 19 ta ’ Settembru 2007.
The main unresolved areas of concern identified by France were concerns regarding long term safety of a daily dose of 90mg etoricoxib in the view of possible increased cardiovascular (CV) risk related to the use of the 90mg dose in the ankylosing spondylitis (AS) indication.
L- oqsma ewlenin ta ’ tħassib li ma ġewx riżolti identifikati minn Franza kienu jinkludu tħassib rigward sigurtà għal tul ta ’ żmien twil ta ’ doża ta ’ 90 mg etoricoxib meħuda kuljum rigward il- possibbiltà ta ’ żieda fir- riskju kardjovaskulari (CV) relatat mal- użu ta ’ doża ta ’ 90 mg fl- indikazzjoni ta ’ spondilite ankilosanti (AS).
France considered that a review of the benefit/ risk profile of Arcoxia was needed.
Franza kienet tal- fehma li kienet meħtieġa reviżjoni tal- profil bejn il- benefiċċji u r - riskji ta ’ Arcoxia.
The arbitration procedure was discussed by the CHMP at its plenary meeting in September 2007 and a Rapporteur (Dr.
Il- proċedura ta ’ arbitraġġ ġiet diskussa mis- CHMP fil- laqgħa plenarja tiegħu f’ Settembru 2007 u ġew maħtura Relatur (Dott.
Karl Broich) and Co-Rapporteur (Dr.
Karl Broich) u Korelatur (Dott.
The referral procedure was initiated on 20 September 2007 with the adoption of a CHMP list of questions that were to be addressed by the marketing authorisation holders (MAHs).
Il- proċedura ta ’ referenza nbdiet fl- 20 ta ’ Settembru 2007 bl- adozzjoni ta ’ lista ta ’ mistoqsijiet tas- CHMP li kellhom jiġu ndirizzati mid- detenturi tal- awtorizzazzjoni għat- tqegħid fis- suq (MAHs).
During the February 2008 plenary meeting Dr.
Waqt il- laqgħa plenarja ta ’ Frar 2008, id- Dott.
Rafe Survana was appointed Co-Rapporteur, replacing Dr.
Rafe Survana nħatar bħala Korelatur, biex jieħu post id- Dott.
Written explanations were provided by the MAHs on 14 December 2008, 5 May 2008, 12 June 2008 and 20 June 2008.
L- MAHs taw spjegazzjonijiet bil- miktub 12 ta ’ Ġunju 2008 u fl- 20 ta ’ Ġunju 2008.
The CHMP concluded that the data confirmed the known renovascular safety profile of etoricoxib (hypertension, oedema and congestive heart failure).
Is- CHMP ikkonkluda li d- dejta kienet tikkonferma l- profil ta ’ sigurtà renovaskulari magħruf ta ’ etoricoxib (ipertensjoni, edema u insuffiċjenza kardijaka konġestiva).
The data further confirmed a similar CV thrombotic risk like diclofenac and some degree of upper gastrointestinal (GI) safety advantage over naproxen and diclofenac (though no particular lower GI safety advantage).
Id- dejta kompliet tikkonferma riskju trombotiku CV simili għal diclofenac u ċertu livell ta ’ sigurtà tal- passaġġ gastrointestinali (GI) ta ’ fuq meta mqabbel ma ’ naproxen u diclofenac (minkejja li ma kien jidher l- ebda livell iktar baxx ta ’ vantaġġ ta ’ sigurtà GI).
There was little direct comparative safety data for individual non-steroidal anti-inflammatory drugs (NSAIDs) other than diclofenac and naproxen.
Kien hemm ftit dejta dwar is- sigurtà li setgħet titqabbel direttament għal mediċini antinfjammatorji mhux sterojdali individwali (NSAID) minbarra diclofenac u naproxen.
It was therefore difficult to determine risks for etoricoxib compared with ibuprofen, ketoprofen or other less-commonly used NSAIDs.
Għalhekk kien diffiċli biex jiġu determinati r- riskji għal etoricoxib meta mqabbel ma ’ ibuprofen, ketoprofen jew NSAIDs li jintużaw inqas.
Reproduction is authorised provided the source is acknowledged. within 2 weeks of treatment initiation.
Id- dejta dwar l- użu tal- mediċini wriet li ċerti pazjenti li jbatu minn pressjoni tad- demm għolja qegħdin jibdew jieħdu etoricoxib.
Healthcare professionals were to be reminded of these measures through a communication letter (Dear Healthcare Professional Letter).
Il- professjonisti fil- qasam tas- saħħa għandhom jiġu mfakkra f’ dawn il- miżuri permezz ta ’ ittra ta ’ komunikazzjoni (Dear Healthcare Professional Letter).
Data from clinical studies showed clinically meaningful treatment effect for the 90mg etoricoxib once daily dose for AS indication; however, some data are available to indicate that lower doses might also show effect.
Madankollu, hemm disponibbli xi dejta li tindika li dożi iktar baxxi jistgħu wkoll ikollhom effett.
The CHMP therefore recommended that dose finding studies should be explored to conclude if treatment with 60mg once daily would also be adequate for some patients.
Għalhekk, is- CHMP irrakkomanda li għandhom jitwettqu studji biex jiddeterminaw id- doża meħtieġa sabiex jiġi konkluż jekk it- trattament b’ 60 mg darba kuljum ikunx xieraq ukoll għal ċerti pazjenti.
Based on the review of the available data, the CHMP considered that the benefits of etoricoxib outweigh the risks in the treatment of ankylosing spondylitis.
Abbażi tar- reviżjoni tad- dejta disponibbli, is- CHMP ikkunsidra li l- benefiċċji ta ’ etoricoxib huma akbar mir- riskji tiegħu fit- trattament tal- ispondilite ankilosanti.
On 26 June 2008, the CHMP, having considered the data provided by the MAHs, recommended the granting of the variation to the marketing authorisations.
Fis- 26 ta ’ Ġunju 2008, is- CHMP, wara li kien ikkunsidra d- dejta pprovduta mill- MAHs, irrakkomanda l- għoti ta ’ varjazzjoni għall- awtorizzazzjonijiet għat- tqegħid fis- suq.
The list of product names concerned is given in Annex I.
Il- lista tal- ismijiet tal- prodotti kkonċernata hija disponibbli fl- Anness I.
The scientific conclusions are provided in Annex II, the amended product information in Annex III and the conditions of the marketing authorisation in Annex IV.
Il- konklużjonijiet xjentifiċi huma pprovduti fl- Anness II, it- tagħrif emendat dwar il- prodott fl- Anness III u l- kondizzjonijiet għall - awtorizzazzjonijiet għat- tqegħid fis- suq fl- Anness IV.
The final opinion was converted into a decision by the European Commission on 9 September 2008.
L- opinjoni finali nbidlet f’ Deċiżjoni mill- Kummissjoni Ewropea fid- 9 ta’ Settembru 2008.
∗ Notes: the information given in this document and its annexes reflects only the CHMP opinion dated 26 June 2008.
∗ Noti: it- tagħrif mogħti f’ dan id- dokument u l- annessi tiegħu jirrifletti biss l- opinjoni tas- CHMP datata s- 26 ta ’ Ġunju 2008.
The Member States’ competent authorities will continue to keep the product under regular review.
L- awtoritajiet kompetenti tal- Istati Membri ser ikomplu jissorveljaw il- prodott b’ mod regolari.
LIST OF THE NAMES, PHARMACEUTICAL FORM(S), STRENGTH(S) OF THE MEDICINAL PRODUCT(S), ROUTE(S) OF ADMINISTRATION, APPLICANT(S) MARKETING AUTHORISATION HOLDER(S) IN THE MEMBER STATES
LISTA TA` L- ISMIJIET, GĦAMLA FARMAĊEWTIKA (GĦAMLIET FARMAĊEWTIĊI), QAWWA (QAWWIET) TAL- PRODOTT( I) MEDIĊINALI, MNEJN JINGĦATA, L - APPLIKANT( I), ID- DETENTUR( I) TA` L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS - SUQ FL- ISTATI MEMBRI
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