qanastek/EMEA-V3 huggingface dataset:
The review concluded that a small increase in the absolute risk for thrombotic events associated with non-selective NSAIDs cannot be excluded although the overall risk benefit/ balance remains positive.
L- evalwazzjoni kkonkludiet li żieda żgħira fir- riskju assolut ta ’ episodji trombotiċi assoċjati ma ’ NSAIDSs mhux selettivi ma tistax tiġi eskluża għalkemm il- bilanċ globali bejn il- benefiċċju u r- riskju jibqa ’ pożittiv.
GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS
RAĠUNIJIET GĦALL- EMENDAR TAS- SOMMARJU TAL- KARATTERISTIĊI TAL - PRODOTT
− The CHMP considered the referral made under article 31of Directive 2001/ 83/ EC, as amended, for medicinal products containing piroxicam.
− Il- CHMP qies ir- referenza magħmula taħt l- artikolu 31 tad- Direttiva 2001/ 83/ KE, kif emendata, għal prodotti mediċinali li fihom piroxicam.
− In view of the available data, the Committee concluded that there is an increased risk of gastrointestinal and serious skin reactions associated with systemic formulations of piroxicam when compared to other NSAIDs as a group.
− Fid- dawl ta ’ l- informazzjoni disponibbli, il- Kumitat ikkonkluda li hemm riskju akbar ta ’ reazzjonijiet gastro- intestinali u serji tal- ġilda assoċjati ma ’ formulazzjonijiet sistemiċi ta ’ piroxicam meta mqabbel ma ’ NSAIDs oħra bħala grupp.
− The CHMP considered that the benefit/ risk balance for systemic formulations of piroxicam is positive in the treatment of symptomatic relief of osteoarthritis, rheumatoid arthritis or ankylosing spondylitis; however the CHMP considered that the benefit/ risk balance of piroxicam in the treatment of acute conditions is negative and that these indications should be revoked.
− Il- CHMP ikkunsidra li l- bilanċ bejn il- benefiċċju u r- riskju għal formulazzjonijiet sistemiċi ta ’ piroxicam huwa pożittiv fit- trattament ta ’ solliev sintomatiku ta ’ l- osteoartrite, l- artrite rewmatika jew l- ispondilite li tagħqad bl- ankilosi; madankollu l- CHMP ikkunsidra li l- bilanċ bejn il- benefiċċju u r- riskju ta ’ piroxicam fit- trattament ta ’ kondizzjonijiet akuti huwa negattiv u li dawn l- indikazzjonijiet għandhom jiġu revokati.
A number of restrictions on use, strengthened warnings and contraindications have been added to the Summary Product Characteristics and Package Leaflet in relation to gastrointestinal and skin safety.
Għadd ta ’ restrizzjonijiet fuq l- użu, twissijiet imsaħħa u kontra- indikazzjonijiet ġew miżjuda mas- Sommarju tal- Karatteristiċi tal - Prodott u l- Fuljett ta ’ Tagħrif b’ rabta mas- sigurtà gastro- intestinali u tal- ġilda.
− The CHMP concluded that the benefit/ risk balance of systemic formulations of piroxicam containing medicinal products in the agreed restricted indications is favourable.
− Il- CHMP ikkonkluda li l- bilanċ bejn il- benefiċċju u riskju ta ’ formulazzjonijiet sistemiċi ta ’ prodotti mediċinali li fihom piroxicam fl- indikazzjonijiet ristretti maqbula huwa favorevoli.
− The CHMP agreed that no restrictions were required with regards to topical formulations of piroxicam and the benefit/ risk balance remains favourable.
− Il- CHMP qabel li ma kinux meħtieġa restrizzjonijiet fir- rigward ta ’ formulazzjonijiet speċifiċi ta ’ piroxicam u l- bilanċ bejn il- benefiċċju u r- riskju jibqa ’ favorevoli.
As a consequence, the CHMP has recommended to maintain the Marketing Authorisations for all medicinal products referred to in Annex I of the Opinion and to amend the relevant sections of the Summary of Product Characteristics and Package Leaflet of systemic formulations of piroxicam, as set out in Annex III of the Opinion in accordance with Article 31(2) of Directive 2001/ 83/ EC, as amended.
Għalhekk, il- CHMP irrakkomanda li jinżammu l- Awtorizzazzjonijiet għat- Tqegħid fis- Suq tal- prodotti mediċinali kollha li saret referenza għalihom fl- Anness I ta ’ l- Opinjoni u li jiġu emendati t- taqsimiet rilevanti tas- Sommarju tal- Karatteristiċi tal- Prodott u l- Fuljett ta ’ Tagħrif ta ’ formulazzjonijiet sistemiċi ta ’ piroxicam, kif speċifikat fl- Anness III ta ’ l- Opinjoni skond l- Artikolu 31( 2) tad- Direttiva 2001/ 83/ KE, kif emendata.
AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTIONS OF THE SUMMARY OF PRODUCT CHARACTERISTICS FOR SYSTEMIC FORMULATIONS OF PIROXICAM CONTAINING MEDICINAL PRODUCTS
EMENDI GĦAS- SOMMARJU TAL- KARATTERISTIĊI TAL- PRODOTT U L- FULJETT TA ’ TAGĦRIF AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTIONS OF THE SUMMARY OF PRODUCT CHARACTERISTICS FOR SYSTEMIC FORMULATIONS OF PIROXICAM CONTAINING MEDICINAL PRODUCTS
4.1 Therapeutic Indications
4. 1 Indikazzjonijiet terapewtiċi
Indications regarding osteoarthritis, rheumatoid arthritis and ankylosing spondylitis should read as follows: “ Piroxicam is indicated for symptomatic relief of osteoarthritis, rheumatoid arthritis or ankylosing spondylitis.
Piroxicam huwa indikat għas- serħan mis- sintomi ta ’ l- osteoartrite, artrite rewmatojde jew analkajlosing spondilajtis.
Due to its safety profile (see sections 4.2, 4.3 and 4.4), piroxicam is not a first line option should an NSAID be indicated.
Minħabba l- profil tas- sigurtà tiegħu (ara sezzjonijiet 4. 2, 4. 3 u 4. 4), piroxicam m’ għandux ikun l - ewwel għażla jekk ikun indikat NSAID.
The decision to prescribe piroxicam should be based on an assessment of the individual patient's overall risks (see sections 4.3 and 4.4) .”
Id- deċiżjoni li jingħata piroxicam għandha tiġi ibbażata fuq stima tar- riskji globali tal- pazjenti individwali (ara sezzjonijiet 4. 3 u 4. 4).
4.2 Posology and Method of administration
4. 2 Pożoloġija u metodu ta ’ kif għandu jingħata
“ The prescription of piroxicam should be initiated by physicians with experience in the diagnostic evaluation and treatment of patients with inflammatory or degenerative rheumatic diseases.
L- għoti ta ’ piroxicam b’ riċetta ta ’ tabib għandu jiġi mibdi minn tobba b’ esperjenza fl- evalwazjoni dijanjostika u trattament ta ’ pazjenti b’ mard infjammatorju jew rewmatiku deġenerattiv.
The maximum recommended daily dose is 20 mg.
Id- doża massima ta ’ kuljum irrakkomandata hija 20 mg.
Undesirable effects may be minimised by using the minimum effective dose for the shortest duration necessary to control symptoms.
Effetti mhux mixtieqa għandhom jiġu minimizzati permezz ta ’ l- użu tad- doża minima effettiva għall- iqsar tul ta ’ żmien neċessarju biex tikontrolla s- sintomi.
The benefit and tolerability of treatment should be reviewed within 14 days.
Il- benefiċċju u t- tolerabilità tat - trattament għandhom jiġu riveduti fi żmien 14- il jum.
If continued treatment is considered necessary, this should be accompanied by frequent review.
Jekk trattament kontinwu huwa ikkonsidrat meħtieġ, dan għandu jiġi akkumpanjat b’ osservazzjonijiet frekwenti.
Given that piroxicam has been shown to be associated with an increased risk of gastrointestinal complications, the possible need for combination therapy with gastro-protective agents (e. g. misoprostol or proton pump inhibitors) should be carefully considered, in particular for elderly patients .”
Meta wieħed iqis li piroxicam intwera li huwa assoċjat ma ’ riskju akbar ta ’ kumplikazzjoniet gastrointestinali, il- possibbilta ’ ta ’ ħtieġa għal terapija ikkumbinata ma ’ sustanzi gastro- protettivi (eż. misoprostol jew impedituri tal- pompa tal- protoni) għanha tiġi ikkonsidrata bir- reqqa, partikolarment f’ pazjenti anzjani.
Radiculalgia 4.3 Contraindications … []… • “ History of gastro-intestinal ulceration, bleeding or perforation. • Patient history of gastrointestinal disorders that predispose to bleeding disorders such as ulcerative colitis, Crohn’ s disease, gastrointestinal cancers or diverticulitis. • Patients with active peptic ulcer, inflammatory gastrointestinal disorder or gastrointestinal bleeding. • Concomitant use with other NSAIDs, including COX-2 selective NSAIDs and acetyl-salicylic acid at analgesic doses. • Concomitant use with anticoagulants. • History of previous serious allergic drug reaction of any type, especially cutaneous reactions such as erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis. • Hypersensitivity to the active substance, previous skin reaction (regardless of severity) to piroxicam, other NSAIDs and other medications .” … []…
4. 3 Kontra- indikazzjonijiet... []... • Passat mediku ta ’ ulċerazzjoni, fsada jew perforazzjoni gastrointestinali. • Pazjent b’ passat mediku ta ’ disturbi gastrointestinali li jippredisponu għal disturbi ta ’ fsada bħal ma huma kolite ulċerattiva, marda ta ’ Crohn, kanċer gastrointestinali jew divertikulite. • Pazjenti b’ ulċera pepetika attiva, disturbi gastrointestinali infjammatorji jew fsada gastrointestinali. • Użu konomitanti ma ’ NSAIDs oħra, inklużi NSAIDs selettivi għal COX- 2 u acetyl- salicylic acid f’ dożi analgeżisiċi. • Użu konkomitanti ma ’ antikoagulanti • Passat mediku ta ’ reazzjonijiet allerġiċi serji ta ’ kull tip għall- mediċina, speċjalment reazzjonijiet tal- ġilda bħal ma huma eritima multiforme, sindromu ta ’ Stevens- Johnson, nekroliżi epidermali tossika. • Sensitività eċċessiva għas- sustanza attiva, reazzjoni tal- ġilda ta ’ qabel (mingħajr rigward tas - severita ’) għal piroxicam, NSAIDs oħra u medikazzjonijiet oħra.... []...
4.4 Special Warnings and Special Precautions for Use
4. 4 Twissijiet speċjali u prekawzjonijiet għall- użu... []...
… []… “ Undesirable effects may be minimised by using the minimum effective dose for the shortest duration necessary to control symptoms.
Effetti mhux mixtieqa jistgħu jiġu minimizzati bl- użu tad- doża minima effettiva għall- iqsar żmien neċessarju biex tikkontrolla s- sintomi.
The clinical benefit and tolerability should be re-evaluated periodically and treatment should be immediately discontinued at the first appearance of cutaneous reactions or relevant gastrointestinal events .” … []…
Il- benefiċċju u tolerabilità klinika għandhom ikun evalwati mill- ġdid perjodikament u t- trattament għandu jitwaqqaf immedjatament ma ’ l- ewwel dehra ta ’ reazzjonijiet tal- ġilda jew reazzjonijiet gastrointestinali relevanti.... []...
… []… “ Gastrointestinal (GI) Effects, Risk of GI Ulceration, Bleeding, and Perforation.
Effetti gastrointestinali (GI), Riskju ta ’ Ulċerazzjoni, Fsada u Perforazzjoni GI.
NSAIDs, including piroxicam, can cause serious gastrointestinal events including bleeding, ulceration, and perforation of the stomach, small intestine or large intestine, which can be fatal.
NSAIDs, li jinkludu piroxicam, jistgħu jikkaġunaw reazzjonijiet gasrointestinali serji li jinkludu fsada, ulċerazzjoni, u perforazzjoni ta ’ l- istonku, tal- musrana ż- żgħira jew tal- musrana l- kbira, li jistgħu jkunu fatali.
These serious adverse events can occur at any time, with or without warning symptoms, in patients treated with NSAIDs.
Dawn ir- reazzjonijiet avversi serji jistgħu jseħħu fi kwalunkwe ħin, b’ isintomi ta ’ twissija jew mingħajrhom, f’ pazjenti ittrattati b’ NSAIDs..
NSAID exposures of both short and long duration have an increased risk of serious GI event.
Esponimenti għal NSAID kemm għal żmien qasir kif ukoll fit- tul għandhom riskju miżjud ta ’ reazzjoni GI serja.
Evidence from observational studies suggests that piroxicam may be associated with a high risk of serious gastrointestinal toxicity, relative to other NSAIDs.
Evidenza minn studji ta ’ osservazzjoni jissuġġerixxu li piroxicam jista ’ jkun assoċjat ma ’ riskju għoli ta ’ tossiċità gastrointestinali serja, relattiv ma ’ NSAIDs oħra.
Patients with significant risk factors for serious GI events should be treated with piroxicam only after careful consideration (See sections 4.3 and below).
Pazjenti b’ fatturi ta ’ riskju sinifikanti għal reazzjonijiet GI serji għandhom jiġu ittrattati b’ Piroxicam biss wara konsidrazzjoni bir- reqqa (Ara sezzjonijiet 4. 3 u hawn taħt).
(see section 4.2).
Il- possibbilta ’ ta ’ ħtieġa għal terapija ikkumbinata ma ’ sustanzi gastro- protettivi (eż. misoprostol jew impedituri tal- pompa tal- protoni) għandha tiġi ikkonsidrata bir- reqqa (ara sezzjoni 4. 2).
Serious GI Complications Identification of at-risk subjects The risk for developing serious GI complications increases with age.
Kumplikazzjonijiet GI Serji Identifikazzjoni ta ’ individwi fir- riskju Ir- riskju li jiżviluppaw kumplikazzjonijiet GI serji jiżdied ma ’ l- età.
Age over 70 years is associated with high risk of complications.
Età ’ l fuq minn 70 sena hija assoċjata ma ’ riskju għoli ta ’ kumplikazzjoniet.
The administration to patients older than 80 years should be avoided.
L- għoti lil pazjenti ixjeħ minn 80 sena għandha tkun evitata.
Patients taking concomitant oral corticosteroids, selective serotonin reuptake inhibitors (SSRIs) or anti-platelet agents such as low-dose acetylsalicylic acid are at increased risk of serious GI complications (see below and section 4.5).
Pazjenti li qed jieħdu ukoll kortikosterojdi orali, inibituri selettivi tat- teħid ta ’ serotonin (SSRIs) jew sustanzi kontra l- plejtlits bħal ma huwa acetylsalicylic acid f’ doża baxxa huma f’ riskju miżjud ta ’ kumplikazzjonijiet GI serji (ara hawn taħt u sezzjoni 4. 5).
As with other NSAIDs, the use of piroxicam in combination with protective agents (e. g. misoprostol or proton pump inhibitors) must be considered for these at- risk patients.
Bħal b’ NSAIDs oħra, l- użu ta ’ piroxicam f’ kumbinazzjoni ma ’ sustanzi protettivi (eż. misoprostol jew impedituri tal- pompa tal- protoni) għandhom jiġu ikkonsidrati għal dawn il- pazjenti fir- riskju.
Patients and physicians should remain alerted for signs and symptoms of GI ulceration and/ or bleeding during piroxicam treatment.
Pazjenti u tobba għandhom jibqgħu żvelti għal sinjali u sintomi ta ’ ulċerazzjoni gastrointestinali u/ jew fsada waqt trattament b’ piroxicam.
Patients should be asked to report any new or unusual abdominal symptom during treatment.
Il- pazjenti għandhom jiġu mistoqsija biex jirrapportaw kull sintomu addominali ġdid jew mhux tas- soltu waqt it- trattament.
If a gastrointestinal complication is suspected during treatment, piroxicam should be discontinued immediately and additional clinical evaluation and treatment should be considered .” … []…
Jekk kumplikazzjoni gastrointestinali hija issuspettata waqt it- trattament, piroxicam għandu jiġi imwaqqaf immedjatament u evalwazzjoni klinika addizzjonali u trattament addizzjonali għandhom jiġu ikkonsidrati.... []...
… []… “ Skin reactions Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs (see section 4.8).
Reazzjonijiet fil- ġilda Reazzjonijiet fil- ġilda serji, xi wħud fatali, inkluża dermatite esfoljattiva, sidromu ta ’ Stevens - Johnson, u nekroliżi epidermali tossika, ġew irrapportati rari ħafna f’ assoċjazzjoni ma ’ l- użu ta ’ NSAIDs (ara sezzjoni 4. 8).
Evidence from observational studies suggests that piroxicam may be associated with a higher risk of serious skin reactions than other non-oxicam NSAIDs.
Evidenza minn studji ta ’ osservazzjoni tissuġġerixxi li piroxicam jista ’ jkun assoċjat ma ’ riskju ogħla ta ’ reazzjonijiet tal- ġilda serji minn NSAIDs mhux- oxicam oħra.
Patients appear to be at highest risk of these reactions early in the course of therapy, the onset of the reaction occurring in the majority of cases within the first month of treatment.
Pazjenti jidhru li jkunu fl- ogħla riskju ta ’ dawn ir- reazzjonijiet kmieni fil- kors ta ’ terapija, il- bidu tar - reazzjoni jseħħ fi żmien l- ewwel xahar tat- trattament fil- maġġoranza tal- każijiet.
Piroxicam should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity .” … []…
Piroxicam għandu jitwaqqaf ma ’ l- ewwel dehra ta ’ raxx fil- ġilda, leżjonijiet mukożali, jew xi sinjal ieħor ta ’ sensittività eċċessiva.... []...
4.5 Interaction with other Medicinal Products and other forms of Interaction
4. 5 Prodotti mediċinali oħra li ma jaqblux ma ’ dan il- prodott u affarjiet oħra li jistgħu jibdlu l- effett farmaċewtiku tal- prodott
… []… “ As with other NSAIDs, the use of piroxicam together with acetyl-salicylic acid or concomitant use with other NSAIDs, including other piroxicam formulations, must be avoided, since data are inadequate to show that such combinations produce greater improvement than that achieved with piroxicam alone; moreover, the potential for adverse reactions is enhanced (see section 4.4).
Bħal b’ NSAIDs oħra, l- użu ta ’ piroxicam flimkien ma’ acetyl- salicylic acid jew użu konkomitanti ma ’ NSAIDs oħra, inklużi formulazzjonijiet ta ’ piroxicam oħra, għandhom jiġu evitati, peress li d- dejta mhix adegwata biex turi li kumbinazzjonijiet bħal dawn jipproduċu titjib akbar milli dak miksub b’ piroxicam waħdu; barra minn hekk, il- potenzjal għal reazzjonijiet avversi huwa awmentat (ara sezjoni 4. 4).
Human studies have shown that concomitant use of piroxicam and acetyl-salicylic acid reduces the plasma piroxicam concentration to about 80% of the usual value Corticosteroids: increased risk of gastrointestinal ulceration or bleeding (see section 4.4).
Studji fil- bniedem urew li l- użu konkomitanti ta ’ piroxicam u acetyl- salicylic acid inaqqas il- konċentrazzjoni ta ’ piroxiccam fil- plażma għal madwar 80% tal- valur tas- soltu.
Anti-coagulants:
Anti- koagulanti:
NSAIDs, including piroxicam, may enhance the effects of anti-coagulants, such as warfarin.
NSAIDs, li jinkludu piroxicam, jistgħu jawmentaw l- effetti ta ’ anti- koagulanti, bħal warfarin.
Therefore, the use of piroxicam with concomitant anticoagulant such as warfarin should be avoided.
Għalkekk l- użu ta ’ piroxicam ma ’ antikoagulant bħal warfarin għandu jiġi evitat (ara sezzjoni 4. 4).
(see section 4.3).
Sustanzi kontra l- plejtlits u inibituri selettivi tat- teħid ta ’ serotin (SSRIs): riskju ogħla ta ’ fsada gastrointestinali (ara sezzjoni 4. 4).... []...
Anti-platelet agents and selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal bleeding (see section 4.4) .” … []… AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTIONS OF THE PACKAGE LEAFLETFOR SYSTEMIC FORMULATIONS OF PIROXICAM CONTAINING MEDICINAL PRODUCTS
AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTIONS OF THE PACKAGE LEAFLET FOR SYSTEMIC FORMULATIONS OF PIROXICAM CONTAINING MEDICINAL PRODUCTS
WHAT IS PIROXICAM [Invented name] AND WHAT IT IS USED FOR …. []… “ Before prescribing piroxicam, your doctor will assess the benefits this medicine may give you against your risk of developing side effects.
Qabel ma tinkiteb riċetta għal piroxicam, it- tabib tiegħek ser janalizza l- benefiċċji ta ’ din il- mediċina fuqek meta mqabbla mar- riskji li tiżviluppa effetti sekondarji.
Your doctor may need to give you check-ups and will tell you how often you need to be checked, due to your taking piroxicam.
It- tabib tiegħek ikollu bżonn jagħmel check- ups u ser jgħidlek kemm għandek tiġi ċċekkjat ta ’ spiss, meta inti tkun qed tieħu piroxicam.
Piroxicam [Invented name] is used to relieve some symptoms caused by osteoarthritis (arthrosis, degenerative joint disease), rheumatoid arthritis and ankylosing spondylitis (rheumatism of the spine), such as swelling, stiffness and joint pain.
Piroxicam [Isem inventat] jintuża għal solljev ta ’ xi sintomi li jiġu kkawżati minn osteoartrite (arthrosi, mard deġenerattiv tal- ġogi), artrite rewmatojde u ankajlosing spondilajtis (rewmatiżmu tax - xewka tad- dahar), bħal nefħa, ebusija u uġigħ fil- ġog.
It does not cure arthritis and will help you only as long as you continue to take it.
Hu ma jfejjaqx l- artrite u ser jgħinek biss sakemm tibqa tieħdu.
Your doctor will prescribe piroxicam to you only when you have had unsatisfactory relief of symptoms with other non-steroidal anti-inflammatory medicines (NSAIDs) .” …. []…
It- tabib tiegħek ser jiktiblek riċetta għal piroxicam biss meta ma ma jibdiex ikollok solljev sodisfaċenti tas- sintomi b’ mediċini anti- infjammatorji mhux sterojdi oħra (NSAIDs).... []...
DO NOT TAKE PIROXICAM: …. []… • “ If you previously had a stomach or intestinal ulcer, bleeding or perforation. • If you currently have stomach or intestinal ulcer, bleeding or perforation. • If you have or have had a history of gastrointestinal disorders (inflammation of the stomach or intestines) that predispose to bleeding disorders such as ulcerative colitis, Crohn’ s disease, gastrointestinal cancers, diverticulitis (inflamed or infected pouches/ pockets in the colon). • If you are taking other NSAIDs, including COX-2 selective NSAIDs and acetyl-salicylic acid, a substance present in many medicines used to relieve pain and lower fever. • If you are taking anticoagulants, such as warfarin, to prevent blood clots. • If you previously had a serious allergic drug reaction to piroxicam, other NSAIDs and other medications, especially serious skin reactions (regardless of severity) such as exfoliative dermatitis (intense reddening of skin, with skin peeling off in scales or layers), vesiculo-bullous reactions (Stevens-Johnson syndrome, a condition with red blistered, eroded, bloody or crusted skin) and toxic epidermal necrolysis, (a disease with blistering and peeling of the top layer of skin) .” …. []… • “ If any of these applies to you, you should not be given piroxicam.
• Jekk qabel kellek xi ulċera ta ’ l- istonku jew ta ’ l- imsaren, fsada jew perforazzjoni. • Jekk attwalment għandek ulċera, fsada jew perforazzjoni. ta ’ l- istonku jew ta ’ l- imsaren • Jekk għandek jew kellek passat mediku ta ’ disturbi gastrointestinali (infjammazzjoni ta ’ l- istonku jew ta ’ l- imsaren) li jippredisponu disturbi ta ’ fsada bħal kolite ulċerattiva, il- marda ta ’ Crohn, kanċer gastrointestinali, divertikulite (pawċis/ bwiet infjammati jew infettati fil- kolon). • Jekk qed tieħu NSAIDs oħra, li jinkludu NSAIDs silettivi ta ’ COX- 2 u acetyl- salicylic acid, sustanza li tinsab f’ ħafna mediċini li jtaffu l- uġigħ u jnaqqsu d- deni. • Jekk qed tieħu antikoagulanti, bħal warfarin, biex jipprevjeni l- emboli tad- demm. • Jekk qabel kellek xi reazzjonijiet allerġiċi serji tal- mediċina għal piroxicam, NSAIDs oħra u medikazzjonijiet oħra, speċjalment reazzjonijiet serji tal- ġilda (mingħajr riqward għas- severità) bħal dermatite eksfoljattiva (ħmura qawwija tal- ġilda, bil- ġilda titqaxxar fi qxur jew saffi), reazzjonijiet b’ vesikoli – b’ infafet (sindromu ta ’ Stevens- Johnson, kundizzjoni b’ ġilda ħamra b’ infafet, xedd, demm u bil- qoxra) u nekrolisi epidermali tossika, (marda b’ infafet u qxur tas- saff ta ’ fuq tal- ġilda)... []...
Tell your doctor immediately .” …. []…
Għid lit - tabib tiegħek minnufih.
TAKE SPECIAL CARE WITH… …. []… “ Take special care with [Invented name] and always tell your doctor before using [Invented name]: like all non-steroidal-anti-inflammatory drugs, [Invented name] can cause serious reactions in the stomach and intestines, such as pain, bleeding, ulceration, and perforation.
Oqgħod attent ħafna b ’ [Isem inventat] u dejjem għid lit- tabib tiegħek qabel ma tuża [Isem inventat]: bħal kull mediċina anti- infjammatorja mhux sterjde, [Isem inventat] jista ’ jikkaġuna reazzjonijiet serji fl- istonku u l- imsaren, bħal uġigħ, fsada, ulċerazzjoni u perforazzjoni.
You should immediately stop taking piroxicam and tell your doctor if you have stomach pain, or any sign of bleeding in the stomach or intestines, such as passing black or bloodstained bowel movements, or vomiting blood.
Għandek tieqaf tieħu piroxicam minnufih u għarraf lit- tabib jekk għandek uġigħ fl- istonku, jew kwalunkwe sinjal ta ’ fsada fl- istonku jew fl- imsaren, bħal ippurgar sewdieni jew ippurgar bid- demm jew remettar bid- demm.
You should immediately stop taking piroxicam and tell your doctor if you have any allergic reaction such as a skin rash, swelling of the face, wheezing or difficulty breathing.
Għandek tieqaf tieħu piroxicam minnufih u għarraf lit- tabib tiegħek jekk ikollok xi reazzjoni allerġika bħal raxx fuq il- ġilda, nefħa tal- wiċċ, tħarħir jew diffikultà biex tieħu n- nifs.
If you are over 70 years old, your doctor may wish to minimise treatment duration and to see you more often while you are taking piroxicam.
Jekk għandek aktar minn 70 sena, it- tabib tiegħek għandu mnejn ikun irid inaqqas it- til tat- tratatment u jarak aktar ta ’ spiss waqt li qed tieħu piroxicam.
If you are over 70 years old, or you are taking other medicines like corticosteroids or certain drugs for depression called selective serotonin reuptake inhibitors (SSRIs), or acetylsalicylic acid to prevent blood clotting, your doctor may like to prescribe you together with [Invented name] a medicine for protecting your stomach and intestines.
Jekk għandek aktar minn 70 sena, jew jekk qed tieħu mediċini oħra bħal kortikosterojdi jew ċertu mediċini għad- depressjoni li jissejħu inibituri selettivi tat- teħid ta ’ serotonin (SSRIs), jew acetylsalicyclic acid li jipprevjeni t- tagħqid tad- demm, it- tabib tiegħek għandu mnejn ikun jixtieq jippreskrivi [Isem inventat] ma ’ mediċina oħra li tipproteġi l- istonku u l- imsaren tiegħek.
You should not take this medicine if you are older than 80 years.
You should not take this medicine if you are older than 80 years.
If you have or had any medical problems or any allergies or if you are not sure as to whether you can use piroxicam tell your doctor before using this medicine.
Jekk għandek jew kellek xi probemi ta ’ saħħa jew xi allerġiji jew jekk m’ intix żgur jekk għandekx tuża piroxicam staqsi lit- tabib tiegħek qabel tieħu din il- mediċina.
Make sure you have told your doctor about any other medicines that you are taking, including those that you have bought without a prescription .” …. []…
Kun żgur li tkun għidt lit- tabib tiegħek dwar xi mediċini oħra li tkun qed tieħu, inkluż dawk li qed tieħu mingħajr riċetta tat- tabib.
TAKING OTHER MEDICINES …. []… “ Tell your doctor about any other medicines you are taking or took recently (in the last week) – even medicines you bought yourself without a prescription.
Għarraf lit- tabib tiegħek dwar mediċini oħra li qed tieħu jew ħadt riċentement (fl- aħħar ġimgħa) – anke mediċini li xtrajt int stess mingħajr riċetta tat- tabib.
Medicines can sometimes interfere with each other.
Il- mediċini għandhom mnejn jinterferixxu ma ’ xulxin.
Your doctor may limit your use of piroxicam or other medicines, or you may need to take a different medicine.
It- tabib tiegħek għandu mnejn jirristrinġi l- użu ta ’ piroxicam jew mediċini oħra, jew inkella jaf ikollok bżonn tieħu mediċina differenti.
It’ s especially important to mention:
Huwa importanti ħafna li ssemmi:
- if you are taking aspirin or other non-steroidal anti-inflammatory drugs for pain relief
- jekk qed tieħu l- aspirina jew mediċini ta ’ kontra l- infjammazzjoni mhux sterojdi għal solljiev ta ’ l -
- if you are taking corticosteroids, which are drugs given to treat a variety of conditions such as
- jekk qed tieħu kortikosterojdi li huma mediċini li jingħataw biex jittrattaw varjetà ta ’ kundizzjonijiet
allergies and hormone imbalances
bħal allerġiji u żbilanċi fl- ormoni
- if you are taking anticoagulants such as warfarin to prevent blood clots
- jekk qed tieħu antikoagulanti bħal warfarina sabiex tipprevjeni t- tagħqid tad- demm
- if you are taking certain drugs for depression called selective serotonin re-uptake inhibitors (SSRI)
- jekk qed tieħu ċertu mediċini għad- depressjoni li jissejħu inibituri selettivi tat- teħid tas- serotonin
- if you are taking any drugs, such as acetylsalicylic acid to prevent platelet clumping
- jekk qed tieħu xi mediċini, bħal aspirina, li jipprevjeni li jkun hemm tagħqid ta ’ plejtlets
…. []…
... []...
- If any of these applies to you tell your doctor immediately .”
Jekk xi wieħed minn dawn japplika għalik, għarraf lit- tabib tiegħek minnufih.... []...
…. []…
HOW TO TAKE PIROXICAM... []...
HOW TO TAKE PIROXICAM …. []… “ Always use piroxicam exactly as your doctor has told you.
Dejjem għandek tieħu Piroxicam skond il- parir tat- tabib.
Your doctor will give you a regular check-up to make sure you are taking the optimal dose of piroxicam.
It- tabib tiegħek ser jagħmilhek check- up regolari sabiex jiżgura li qed tingħata l- aħjar doża ta ’ piroxicam.
Your doctor will adjust your treatment to the lowest dose that best controls your symptoms.
It- tabib tiegħek ser jaġġusta it- trattament tiegħek għad- doża l- aktar baxxa li l- aħjar tikkontrolla s- sintomi tiegħek.
Under no circumstances should you change the dose without first speaking to your doctor.
Taħt l- ebda ċirkostanza m’ għandek tibdel id- doża mingħajr ma tkellem lit- tabib l- ewwel.
Adults and the elderly:
Adulti u l- anzjani:
The maximum daily dose is 20 milligrams of piroxicam as one single daily dose.
Id- doża massima ta ’ kuljum hi ta ’ 20 milligramma ta ’ piroxicam bħala doża waħdanija kuljum.
If you are older than 70 years your doctor may prescribe a lower daily dose and reduce the duration of treatment.
Jekk inti għandek aktar minn 70 sena it- tabib tiegħek ser jippreskrivi doża aktar baxxa għal kuljum u ser inaqqas il- perijodu ta ’ żmien ta ’ trattament.
Your doctor may prescribe piroxicam with another medicine to protect your stomach and intestine for potential side effects.
It- tabib tiegħek għandu mnejn jippreskrivi piroxicam ma ’ mediċina oħra sabiex jiġu protetti l- istonku tiegħek u imsarenek għal effetti sekondarji potenzjali.
Do not increase the dose If you feel that the medicine is not very effective, always talk to your doctor.
Iżżidx id- doża Jekk tħoss li l- mediċina mhix effettiva, dejjem kellem lit- tabib tiegħek.
If you forget to use piroxicam:
Jekk tinsa tieħu piroxicam:
Take it as soon as you remember.
Ħudu meta tiftakar.
If it is almost time for your next dose, do not take the dose you have missed, just take the next dose at the correct time.
Jekk ikun kważi wasal il- ħin għad- doża li jmissek tieħu, tieħux id- doża li tkun insejt tieħu, ħu biss id- doża li jkun imissek tieħu fil- ħin li suppost.
Do not double the dose.
Tieħux doża doppja.
If you have any further questions on the use of this product, ask your doctor .” …. []… ANNEX IV
ANNESS IV
CONDITIONS OF THE MARKETING AUTHORISATION National Competent Authorities (NCA) shall ensure that the following conditions are fulfilled by the Marketing Authorisation Holders:
KUNDIZZJONIJIET TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ L- Awtoritajiet Nazzjonali Kompetenti (NCA) għandhom jiżguraw li l- kundizzjonijiet segwenti jiġu sodisfatti mid- Detenturi ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq:
- A Direct Healthcare Professional Communication (DHPC) must be sent to all Health Care
- Trid tintbagħat Komunikazzjoni Diretta ta ’ Professjonist fil- Qasam tas- Saħħa (DHPC) lill -
Professionals who prescribe piroxicam according to national practice.
Professjonisti kolha fil- Qasam tas- Saħħa li jippreskrivu piroxicam skond prattika nazzjonali.
This communication should inform healthcare professionals of the risks of gastrointestinal and skin reactions associated with piroxicam and should be in line with the DHPC endorsed by the CHMP.
Din il- komunikazzjoni għandha tinforma lill- professjonisti tal- kura tas- saħħa dwar ir- riskji ta ’ reazzjonijiet gastro- intestinali u tal- ġilda assoċjati ma ’ piroxicam u għandha tkun konformi mad- DHPC approvata mill- CHMP.
London, 20 September 2007 EMEA/ 380917/ 2007
Londra, 20 ta ’ Settembru 2007 EMEA/ 470092/ 2007
COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 31(2) REFERRAL
OPINJONI TAL- KUMITAT DWAR PRODOTTI MEDIĊINALI GĦALL- UŻU MILL - BNIEDEM (CHMP) WARA REFERENZA SKOND L- ARTIKOLU 31( 2)
PIROXICAM CONTAINING MEDICINAL PRODUCTS
PRODOTTI MEDIĊINALI LI FIHOM PIROXICAM
International Non-Proprietary Name (INN): piroxicam
Isem Internazzjonali Mhux Patentat (INN): piroxicam
BACKGROUND INFORMATION *
TAGĦRIF ĠENERALI *
Piroxicam is a non-steroidal anti-inflammatory drug (NSAID) with anti-inflammatory, analgesic and antipyretic properties.
Piroxicam huwa mediċina anti- infjammatorja mhux sterojdali (SNAID) bi kwalitajiet anti - infjammatorji, analġeżiċi u antipiretiċi.
Further to a request from the European Commission the CHMP reviewed safety data on non-selective NSAIDs.
B’ referenza għal talba mill- Kummissjoni Ewropea, il- CHMP evalwa dejta dwar is- sigurtà tal - mediċina fuq NSAIDs mhux selettivi.
This review, which concluded in October 2005, did not reveal any new safety concerns for the class of NSAIDs as a whole.
Din l- evalwazzjoni, li ntemmet f’ Ottubru 2005, ma żvelat l- ebda tħassib ġdid relatat mas- sigurtà għall- klassi ta ’ l- NSAIDs b’ mod ġenerali.
This review was finalised in June 2006.
Din l- evalwazzjoni ntemmet f’ Ġunju 2006.
The review found that limited epidemiological data and spontaneous adverse drug reaction data provided a signal of increased risk of gastrointestinal and skin reactions (including life-threatening bullous reactions) for piroxicam relative to other non-selective NSAIDs.
Din l- evalwazzjoni sabet li dejta epidemjoloġika limitata u dejta spontanja dwar ir- reazzjonijiet avversi tal- mediċina pprovdiet sinjal ta ’ riskju akbar ta ’ reazzjonijiet gastro- intestinali u tal- ġilda (fosthom reazzjonijiet bullużi ta ’ theddida għall- ħajja) għal piroxicam meta mqabbel ma ’ NSAIDs oħra mhux selettivi.
The CHMP considered that the assessment raised concerns on the benefit/ risk balance of piroxicam and informed the European Commission accordingly.
Il- CHMP ikkunsidra li l- evalwazzjoni qajjmet tħassib fuq il- bilanċ bejn il- benefiċċju u r- riskju ta ’ piroxicam u informa lill- Kummissjoni Ewropea f’ dan ir- rigward.
On 2 August 2006, the European Commission referred the matter to the EMEA under Article 31 of Directive 2001/ 83/ EC, as amended, for piroxicam containing medicinal products.
Fit- 2 ta ’ Awwissu 2006, il- Kummissjoni Ewropea rreferiet il- kwistjoni lill- EMEA skond l- Artikolu 31 tad- Direttiva 2001/ 83/ KE, kif emendata, għal prodotti mediċinali li fihom piroxicam.
The reasons for referral concerned the risk of gastrointestinal and skin reactions.
Ir- raġunijiet għar- riferiment kienu jikkonċernaw ir- riskju ta ’ reazzjonijiet gastro- intestinali u tal- ġilda.
The referral procedure started on the 21 September 2006.
Il- proċedura tar- riferiment bdiet fil- 21 ta ’ Settembru 2006.
The Rapporteur and Co-Rapporteur appointed were Dr Rossi and Dr Calvo-Rojas respectively.
Calvo- Rojas rispettivament.
Written explanations were provided by the Marketing Authorisation Holders (MAH) on 18 December 2006 and 13 April 2007.
Id- Detenturi ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq (MAH) ipprovdew spjegazzjonijiet bil - miktub fit- 18 ta ’ Diċembru 2006 u fit- 13 ta ’ April 2007.
The MAHs presented oral explanations to the CHMP on 22 and 23 May 2007.
Il- MAHs ippreżentaw spjegazzjonijiet verbali lill- CHMP fit- 22 u fit- 23 ta ’ Mejju 2007.
Based on the available data the CHMP considered that the benefit/ risk balance for systemic formulations of piroxicam is positive in the treatment of symptomatic relief of osteoarthritis, rheumatoid arthritis or ankylosing spondylitis; however the CHMP considered that the benefit/ risk balance of piroxicam in the treatment of acute conditions is negative and that these indications should be revoked.
Fuq il- bażi tad- dejta disponibbli, il- CHMP ikkunsidra li l- bilanċ bejn il- benefiċċju u r- riskju għall - formulazzjonijiet sistemiċi ta ’ piroxicam huwa pożittiv fit- trattament tas- serħan mis- sintomi ta ’ l - osteoartrite, l- artrite rewmatika jew l- ispondilite li twassal għall- ankilosi; madankollu l- CHMP ikkunsidra li l- bilanċ bejn il- benefiċċju u r- riskju ta ’ piroxicam fit- trattament ta ’ kundizzjonijiet akuti huwa negattivi u li dawn l- indikazzjonijiet għandhom jiġu revokati.
A number of restrictions on use, contraindications and strengthened warnings have been added to the Summary Product Characteristics and Package Leaflet in relation to gastrointestinal and skin safety.
Kienu miżjuda numru ta ’ restrizzjonijiet fuq l- użu, kontra- indikazzjonijiet u twissijiet aktar b’ saħħithom fis- Sommarju tal - Karatteristiċi tal- Prodott u l- Fuljett ta ’ Tagħrif b’ rabta mas- sigurtà gastro- intestinali u tal- ġilda.
The list of product names concerned is given in Annex I.
Il- lista ta ’ ismijiet tal- prodott konċernat hija mogħtija fl- Anness I.
The scientific conclusions are provided in Annex II, together with 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, flimkien ma ’ l- informazzjoni emendata dwar il- prodott fl- Anness III u l - kundizzjonijiet ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq fl- Anness IV.
(44-20) 74 18 84 00 Fax (44-20) 74 18 86 13 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged The final opinion was converted into a Decision by the European Commission on 7 September 2007.
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged L- opinjoni finali kienet maqluba f’ Deċiżjoni mill- Kummissjoni Ewropea fis- 7 ta ’ Settembru 2007.
∗ Notes: the information given in this document and annexes reflects only the CHMP Opinion dated 21 June 2007.
∗ Noti: l- informazzjoni mogħtija f’ dan id- dokument u fl- annessi tirrifletti biss l- Opinjoni tal- CHMP datata 21 ta ’ Ġunju 2007.
The Member states competent Authorities will continue to keep the product under regular review.
L- Awtoritajiet kompetenti ta ’ l- Istati Membri ser ikomplu jżommu l- prodott taħt osservazzjoni regolari.
LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANTS AND MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES
LISTA TA ’ L- ISMIJIET, L- GĦAMLIET FARMAĊEWTIĊI, IL- QAWWIET TAL- PRODOTTI MEDIĊINALI, MNEJN JINGĦATA, L- APPLIKANTI U D- DETENTUR TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ FL- ISTATI MEMBRI
Pharmaceutical Form Route of administration
Għamla Farmaċewtika Mnejn jingħata
50μ g 100μ g 200μ g 300μ g 400μ g 600μ g 800μ g
Pillola għal taħt l- ilsien Użu għal taħt l- ilsien
Sublingual tablet Sublingual use
Galabank Business Park, Galashiels TD1 1QH Ir- Renju Unit
Cyprus
Rapinyl1
ProStrakan Ltd, Galabank Business Galashiels TD1 1QH UK
100µg 200µg 300µg 400µg 600µg 800µg
Park,
Ċipru
1 Name approval pending
1 Isem Approvat Pendenti
Sublingual tablet Sublingual use
Isem Approvat Pendenti
2 Name approval pending 3 Member State
3 Stat Membru
ProStrakan Ltd, Galabank Business Galashiels TD1 1QH UK
Galabank Business Park, Galashiels TD1 1QH Ir- Renju Unit
Latvia
L- Italja
3 Name approval pending 5 Member State
3 Isem Approvat Pendenti
Lithuania
Il- Latvija
Luxembourg
Il- Litwanja
Norway
Il- Lussemburgu
Poland
In- Norveġja
Slovenia
Ir- Repubblika
Spain
Slovakka
4 Name approval pending 7 Member State
7 Stat Membru
Sweden
Rapinyl
ProStrakan Ltd, Galabank Business Park, Galashiels TD1 1QH UK
Galabank Business Park, Galashiels TD1 1QH Ir- Renju Unit
Abstral
Rapinyl4
United Kingdom
L- Iżvezja
8 ANNEX II
8 Stat Membru
SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARIES OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET PRESENTED BY THE EMEA
Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq
9 SCIENTIFIC CONCLUSIONS
9 ANNESS II
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF RAPINYL AND ASSOCIATED NAMES (see Annex I)
SOMMARJU ĠENERALI TA 'L- EVALWAZZJONI XJENTIFIKA TA' RAPINYL U TA 'L - ISMIJIET ASSOĊJATI (ara l- Anness I)
A marketing authorization application was submitted by the Applicant ProStrakan Ltd through the Decentralised Procedure for Rapinyl, a sublingual tablet containing 50, 100, 200, 300, 400, 600 or 800 µg fentanyl, as citrate.
L- applikant, ProStrakan Ltd, issottometta applikazzjoni għal awtorizzazzjoni għat- tqegħid fis- suq permezz tal- Proċedura Deċentralizzata għal Rapinyl, pillola għal taħt l- ilsien li fiha 50, 100, 200, 300, 400, 600 jew 800 µg fentanyl, bħala ċitrat (citrate).
Fentanyl is a well-known and widely used synthetic short acting strong opioid analgesic, used in the treatment of patients with severe pain.
Fentanyl huwa analġeżiku oppjojdi ta 'sinteżi qawwi b' tul ta' azzjoni qasir, li huwa magħruf sewwa u jintuża b' mod komuni fit- trattament ta 'pazjenti b' uġigħ gravi.
Rapinyl is intended for the treatment of breakthrough pain in patients using opioid therapy for chronic cancer pain.
Rapinyl huwa maħsub għat- trattament ta 'wġigħ episodiku (breakthrough) qawwi fil - pazjenti ttrattati bl- oppjojdi għall- uġigħ kroniku tal- kanċer.
The application was based on literature data on fentanyl, supplemented with pharmacokinetic data for Rapinyl and a comparison of Rapinyl bioavailability with Actiq lozenge, an authorised transmucosally administered fentanyl on demand.
L- applikazzjoni kienet ibbażata fuq tagħrif mil- letteratura dwar fentanyl, supplimentat b' tagħrif farmakokinetiku dwar Rapinyl u tqabbil tal- bijodisponibilità ta 'Rapinyl mal- mustardina mediċinali Actiq, fentanyl awtorizzat li jingħata minn ġol- mukuża meta mitlub.
Pharmacokinetic characterisation following treatment with Rapinyl and pharmacokinetic comparisons of Rapinyl versus Actiq have been used as a basis for bridging to the extensive published data regarding clinical efficacy and safety data for authorized fentanyl products.
Il- karatterizzazzjoni farmakokinetika wara trattament b' Rapinyl u t- tqabbil farmakokinetiku ta 'Rapinyl kontra Actiq intużaw bħala bażi ta' biex jinħoloq pont (bridging) għat- tagħrif estensiv ippubblikat fir- rigward ta 'l - effikaċja klinika u t- tagħrif dwar is- sigurtà għal prodotti awtorizzati ta' fentanyl.
Thus, only limited clinical data have been generated for the use of Rapinyl.
Għalhekk, ġie ġġenerat biss tagħrif kliniku limitat dwar l- użu ta 'Rapinyl.
A number of Concerned Member States considered that the bridging strategy was unacceptable and insufficient and that the fast dissolution of the Rapinyl tablet might be indicative of a higher Cmax and shorter Tmax.
Għadd ta 'Stati Membri Konċernati ħassew li l- istrateġija ta' bridging kienet inaċċettabbli u mhux suffiċjenti u t- taħlil mgħaġġel tal- pillola Rapinyl jista 'jkun indikattiv ta' Cmax ogħla u Tmax iqsar.
As a consequence, additional efficacy and safety data were required for the approval of Rapinyl for the management of breakthrough pain in the target population and the procedure was referred to the CHMP.
Minħabba f' hekk, kienet meħtieġa iżjed informazzjoni dwar is- sigurtà u l- effikaċja għall- approvazzjoni ta 'Rapinyl għat- trattament ta' wġigħ penetranti fil- popolazzjoni fil- mira u l- proċedura kienet riferuta lis- CHMP.
The CHMP adopted a List of Questions (LoQ) to be addressed by the Applicant.
Is- CHMP adotta Lista ta 'Mistoqsijiet (LoQ) li kellhom jiġu indirizzati mill- Applikant.
The Applicant provided an overview of the current knowledge of cancer breakthrough pain (BTP), describing the currently available treatment, and the published data and available safety and efficacy data for other fentanyl products, concluding that fentanyl is an ideal analgesic for treatment of breakthrough pain.
L- applikant ipprovda ħarsa ġenerali ta 'l- għarfien attwali dwar l- uġigħ episodiku qawwi tal- kanċer (BTP), fejn iddeskriva t- trattament li teżisti bħalissa, u t- tagħrif ippubblikat u t- tagħrif disponibbli dwar is- sigurtà u l- effikaċja għal prodotti oħra li fihom fentanyl, u kkonkluda li fentanyl huwa analġeżiku ideali għat- trattament ta' l- uġigħ episodiku.
Rapinyl is a rapidly disintegrating sublingual tablet designed to rapidly and predictably deliver fentanyl through the oral mucosa.
Rapinyl huwa pillola għal taħt l- ilsien li tinħall malajr imfassla sabiex twassal malajr u b' mod li jista 'jiġi mbassar fentanyl minn ġol- mukuża orali.
A range of dose strengths allow individualised upward titration from the recommended starting dose to a dose that provides analgesia with acceptable side-effects.
Il - varjetà ta 'dożaġġi disponibbli tippermetti titrazzjoni personalizzata li tiżdied mid- doża inizjali rakkomandata għal doża li tipprovdi serħan mill- uġigħ b' effetti sekondarji aċċettabbli.
The Applicant has characterised the pharmacokinetic profile of Rapinyl by demonstrating rapid delivery, predictable PK over the proposed dose range and also showing that Rapinyl achieves similar plasma concentrations and pharmacokinetic profiles as Actiq at both low and high doses.
L- applikant ikkaratterizza l- profil farmakokinetiku ta 'Rapinyl billi wera twassil rapidu, PK prevedibbli fuq il - varjetà ta' dożaġġi proposta u billi wera wkoll li Rapinyl jikseb konċentrazzjonijiet fil- plażma u profili farmakokinetiċi simili għal Actiq kemm b' dożi baxxi kif ukoll għolja.
Similarly, the Applicant considered the clinical safety of fentanyl products to be well established and well tolerated in both volunteers and the target population and that the pattern of side effects was consistent with other fentanyl products, including those used for treating BTP.
Bl- istess mod, l- applikant ikkunsidra s- sigurtà klinika tal- prodotti li fihom fentanyl bħala stabbilita u ttollerata sewwa kemm fil- voluntiera kif ukoll fil- popolazzjoni fil- mira u li l- mudell ta 'l- effetti sekondarji kien konsistenti ma' prodotti oħra li fihom fentanyl, fosthom dawk użati għat- trattament tal - BTP.
The Applicant provided data supporting the pharmacokinetic bridging strategy and demonstrating that fentanyl delivery from Rapinyl provides effective pain relief in the target population.
L- applikant ipprovda informazzjoni li ssostni l- istrateġija ta 'bridging farmakokinetiku u wera li t- twassil ta' fentanyl minn Rapinyl jipprovdi serħan reali mill- uġigħ fil- popolazzjoni fil- mira.
A statistically significant decrease in pain intensity was achieved and clinically important decreases in pain occurred more rapidly in patients treated with Rapinyl compared to placebo.
Inkiseb tnaqqis statistiku sinifikanti fl- intensità ta 'l- uġigħ u kien hemm tnaqqis kliniku importanti aktar malajr fil- pazjenti ttrattati b' Rapinyl meta mqabbel mal- plaċebo.
The Applicant concluded that Rapinyl is safe and well tolerated in patients, with an appropriate safety-profile of Rapinyl for this indication.
L- applikant ikkonkluda li Rapinyl huwa sigur u ttollerat sewwa fil- pazjenti, bi profil tas- sigurtà xieraq ta 'Rapinyl għal din l- indikazzjoni.
The Applicant further considered the current bridging strategy to be appropriate for the approval of Rapinyl over the 100-800µg dose range for the treatment of BTP in patients as Rapinyl delivers fentanyl within a plasma concentration range already established as safe and effective.
L- Applikant ikkunsidra wkoll l- istrateġija attwali ta 'bridging bħala adatta għall- approvazzjoni ta' Rapinyl fuq il- medda ta 'dożaġġi ta' 100- 800µg għat- trattament tal- BTP fil- pazjenti billi Rapinyl iwassal fentanyl f' medda ta 'konċentrazzjoni fil- plażma li diġà kienet stabbilita bħala mingħajr periklu u effikaċi.
The pharmacokinetics of Rapinyl are dose proportional and predictable with single and multiple dosing and this simple and quick to administer formulation therefore fulfils an unmet need for a product indicated for the treatment of breakthrough pain in cancer patients.
L- imġiba farmakokinetika ta 'Rapinyl hija proporzjonali għad- doża u prevedibbli b' doża waħda jew diversi u għalhekk din il- formulazzjoni li tingħata malajr tissodisfa ħtieġa mhix milħuqa għal prodott indikat għat- trattament ta' wġigħ episodiku qawwi f' pazjenti morda bil- kanċer.
The Applicant also described the proposed Risk Management Plan, the amendments to the Product Information and the education programme directed at healthcare professionals, patients and carers to be introduced at product launch.
L - applikant iddeskriva wkoll il- Pjan propost għall- Ġestjoni tar- Riskju, l- emendi fl- Informazzjoni dwar il- Prodott u l- programm ta 'tagħlim immirat lejn il- professjonisti, il- pazjenti u dawk li jieħdu ħsiebhom li għandu jiġi introdott fit- tnedija tal- prodott.
The Applicant therefore believes the benefit/ risk for Rapinyl to be positive and that the outcome of any further clinical safety and efficacy studies with Rapinyl are predictable and hence, unnecessary.
L- applikant għalhekk jemmen li l- benefiċċju/ riskju ta 'Rapinyl huwa wieħed pożittiv u li r- riżultati ta' kwalunkwe studju oħra dwar l- effikaċja u s- sigurtà klinika huma prevedibbli u għalhekk, mhux meħtieġa.