qanastek/EMEA-V3 huggingface dataset:
In dialysis patients with serious kidney disease, about 40% of the patients taking Parareg had PTH levels below 250 micrograms/ l at the end of the study, compared with about 6% of those taking placebo.
Fil- pazjenti b' mardiet serji tal- kliewi li kienu fuq dijaliżi, madwar 40% tal- pazjenti li kienu qed jieħdu Parareg kellhom livelli tal- PTH inqas minn 250 mikrogrammi/ l fi tmiem l- istudju, meta tqabblu ma ’ madwar 6% ta ’ dawk li kienu qegħdin jieħdu plaċebo.
Parareg brought about a 42% reduction in PTH levels compared with an increase of 8% in patients taking placebo.
Parareg wera tnaqqis ta ’ madwar 42% fil- livelli tal- PTH meta mqabbel ma ’ żieda ta ’ 8% f’ pazjenti li ħadu plaċebo.
Parareg produced a decrease in blood calcium of more than 1 mg/ dl in 62% of the cancer patients (18 out of 29) and in 88% of the patients with primary hyperparathyroidism(15 out of 17).
Parareg irriżulta fi tnaqqis tal- kalċju fid- demm ta ’ aktar minn 1 mg/ dl fi 62% tal- pazjenti bil- kanċer (18 minn 29) u 88% tal- pazjenti b’ iperparatirojdiżmu primarju (15 minn 17).
The results of the additional studies supported the use of Parareg for hypercalcaemia in patients with primary hyperparathyroidism.
Ir- riżultati ta ’ l- istudji addizzjonali kienu favorevoli għall- użu ta ’ Parareg fit- trattament ta ’ iperkalċemija fil- pazjenti b’ iperparatirojdiżmu primarju.
What is the risk associated with Parareg?
X’ inhu r- riskju assoċjat ma ’ Parareg?
The most common side effects with Parareg in secondary hyperparathyroidism (seen in more than 1 patient in 10) are nausea (feeling sick) and vomiting.
L- effetti sekondarji l- aktar komuni b' Parareg f’ iperparatirojdiżmu sekondarju (li dehru f' aktar minn pazjent 1 minn 10) huma nawżea (dardir) u remettar.
For the full list of all side effects reported with Parareg, see the Package Leaflet.
Għal- lista sħiħa ta 'l- effetti sekondarji irrappurtati f' Parareg, ara l- Fuljett ta 'Tagħrif.
Parareg should not be used in people who may be hypersensitive (allergic) to cinacalcet or any of the other ingredients.
Parareg ma għandux jintuża minn persuni li huma sensittivi żżejjed (allerġiċi) għal cinacalcet jew għal xi sustanza oħra tiegħu.
Why has Parareg been approved?
Għaliex ġie approvat Parareg?
The Committee for Medicinal Products for Human Use (CHMP) decided that Parareg’ s benefits are greater than its risks for the treatment of secondary hyperparathyroidism in patients with end-stage renal disease on maintenance dialysis therapy, and for the reduction of hypercalcaemia in patients with parathyroid carcinoma or primary hyperparathyroidism for whom parathyroidectomy would be indicated on the basis of serum calcium levels but in whom parathyroidectomy is not clinically appropriate or is contraindicated.
Il- Kumitat għal Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ Parareg huma akbar mir- riskji għat- trattament ta ’ iperparatirojdiżmu sekondarju f’ pazjenti b’ mard renali avvanzat li huma għaddejjin minn terapija ta ’ dijaliżi ta ’ manutenzjoni, u għat- tnaqqis ta ’ iperkalċemija f’ pazjenti b’ karċinoma tal- paratirojde jew iperparatirojdiżmu primarju li għalihom paratirojdektomija tkun indikata skond il- livelli tal- kalċju fis- serum iżda li dan il- proċess ma jkunx klinikament xieraq għalihom jew ikun kontraindikat.
The Committee recommended that Parareg be given marketing authorisation.
Il- Kumitat irrakkomanda li Parareg jingħata awtorizzazzjoni għat- tqegħid fis- suq.
2/ 3 Other information about Parareg:
Tagħrif ieħor dwar Parareg:
The European Commission granted a marketing authorisation valid throughout the European Union for Parareg on 22 October 2004.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida fl- Unjoni Ewropea kollha, għal Parareg fit- 22 ta 'Ottubru 2004.
The marketing authorisation holder is Dompé Biotec S. p. A.
Id- detentur ta 'l- awtorizzazzjoni għat- tqegħid fis- suq huwa Dompé Biotec S. p. A.
The full EPAR for Parareg is available here.
2/ 3 L- EPAR sħiħ dwar Parareg jista ’ jiġi kkonsultat hawn.
Parareg 30 mg film-coated tablets.
Parareg 30 mg pilloli miksija b’ rita.
Parareg may be used as part of a therapeutic regimen including phosphate binders and/ or Vitamin D sterols, as appropriate (see section 5.1).
Parareg jista ’ jintuża bħala parti minn kors terapewtiku li jinkludi binders ta ’ fosfati u/ jew sterols ta ’ Vitamina D, kif xieraq (ara sezzjoni 5. 1).
It is recommended that Parareg be taken with food or shortly after a meal, as studies have shown that bioavailability of cinacalcet is increased when taken with food (see section 5.2).
Huwa rakkomandat li Parareg jittieħed ma ’ l- ikel jew ftit wara ikla, minħabba li studji wrew li l- biodisponibilità ta ’ cinacalcet tiżdied meta jittieħed ma ’ l- ikel (ara sezzjoni 5. 2).
Tablets should be taken whole and not divided.
Il- pilloli għandhom jittieħdu sħaħ u m’ għandhomx jinqasmu.
Parareg should be used with caution in patients with moderate to severe hepatic impairment and treatment should be closely monitored during dose titration and continued treatment (see sections 4.4 and 5.2).
Parareg għandu jintuża b’ attenzjoni f’ pazjenti b’ indeboliment epatiku minn moderat għal sever u l- kura għandha tiġi sorveljata mill- qrib waqt it - titrazzjoni tad- doża u waqt kura kontinwa (ara sezzjonijiet 4. 4 u 5. 2).
Secondary Hyperparathyroidism
Iperparatirojdiżmu sekondarju u Iperparatirojdiżmu Primarju
Parareg should be titrated every 2 to 4 weeks to a maximum dose of 180 mg once daily to achieve a target parathyroid hormone (PTH) in dialysis patients of between 150-300 pg/ ml (15.9-31.8 pmol/ l) in the intact PTH (iPTH) assay.
Parareg għandu jiġi ttitrat kull ġimgħatejn sa 4 ġimgħat sa doża massima ta ’ 180 mg darba kuljum biex tintlaħaq il- mira tal - ormon tal- paratirojde (PTH) f’ pazjenti bid- dijalisi li hija bejn 150- 300 pg/ ml (15. 9- 31. 8 pmol/ l) f’ analiżi ta ’ PTH intatt (iPTH).
PTH levels should be assessed at least 12 hours after dosing with Parareg.
Il- livelli ta ’ PTH għandhom jitkejjlu ta ’ l- inqas 12- il siegħa wara li ngħatat Parareg.
2 PTH should be measured 1 to 4 weeks after initiation or dose adjustment of Parareg.
2 PTH għandu jitkejjel minn ġimgħa sa 4 ġimgħat wara l- bidu tal- kura jew aġġustament fid- doża ta ’ Parareg.
Either the intact PTH (iPTH) or bio- intact PTH (biPTH) may be used to measure PTH levels; treatment with Parareg does not alter the relationship between iPTH and biPTH.
Il- PTH intatt (iPTH) jew PTH bio- intatt (biPTH) jistgħu jintużaw biex jitkejlu l- livelli ta ’ PTH; kura b’ Parareg ma tibdilx ir- relazzjoni bejn iPTH u biPTH.
During dose titration, serum calcium levels should be monitored frequently, and within 1 week of initiation or dose adjustment of Parareg.
Waqt it- titrazzjoni tad- doża, l- livelli tal- kalċju fis- serum għandhom jiġu sorveljati ta ’ spiss, u wara ġimgħa mill- bidu tal- kura jew minn mindu jkun sar aġġustament fid- doża ta ’ Parareg.
Once the maintenance dose has been established, serum calcium should be measured approximately monthly.
Ladarba id- doża ta ’ manutenzjoni tkun ġiet stabbilita, il- kalċju fis- serum għandu jitkejjel bejn wieħed u ieħor kull xahar.
The recommended starting dose of Parareg for adults is 30 mg twice per day.
Id- doża tal- bidu rakkomandata ta ’ Parareg għall- adulti hija ta ’ 30 mg darbtejn kuljum.
The dosage of Parareg should be titrated every 2 to 4 weeks through sequential doses of 30 mg twice daily, 60 mg twice daily, 90 mg twice daily, and 90 mg three or four times daily as necessary to reduce serum calcium concentration to or below the upper limit of normal.
Id- dożaġġ ta ’ Parareg għandu jiġi ttitrat kull ġimgħatejn sa 4 ġimgħat permeżż ta ’ dożi sekwenzjali ta ’ 30 mg darbtejn kuljum, 60 mg darbtejn kuljum, 90 mg darbtejn kuljum, u 90 mg tlieta jew erba ’ darbiet kuljum, kif neċessarju biex titnaqqas il- konċetrazzjoni ta ’ kalċju fis- serum sa jew inqas mil- limitu ta ’ fuq tan- normal.
Serum calcium should be measured within 1 week after initiation or dose adjustment of Parareg.
Il- kalċju fis- serum għandu jitkejjel wara ġimgħa mill- bidu jew minn mindu jkun sar aġġustament fid - doża ta ’ Parareg.
After titration to the maximum dose of Parareg, serum calcium should be periodically monitored; if clinically relevant reductions in serum calcium are not maintained, discontinuation of Parareg therapy should be considered (see section 5.1).
Wara titrazzjoni sad- doża massima ta ’ Parareg, il- kalċju fis- serum għandu jiġi sorveljat perjodikament; jekk ma jinżamx tnaqqis klinikment rilevanti tal- kalċju fis- serum, għandu jiġi kkunsidrat twaqqif għal kollox tat- terapija b’ Parareg (ara sezzjoni 5. 1).
In three clinical studies of Chronic Kidney Disease (CKD) patients on dialysis, five percent of the patients in both the Parareg and placebo groups reported a history of seizure disorder at baseline.
Fi tlett studji kliniċi f’ pazjenti b’ Mard Kroniku tal- Kliewi (CKD) fuq id- dijalisi, ħamsa fil- mija tal - pazjenti kemm fil- ġrupp ta ’ Parareg kif ukoll fil- grupp tal- plaċebo rrappurtaw passat mediku ta ’ aċċessjonijiet fil- linja bażika.
In these studies, seizures were observed in 1.4% of Parareg treated patients and 0.4% of placebo-treated patients.
F’ dawn l- istudji, aċċessjonijiet kienu osservati f’ 1. 4% tal- pazjenti kkurati b’ Parareg u f’ 0. 4% fil- pazjenti kkurati bil- plaċebo.
3 Hypotension and/ or worsening heart failure
Pressjoni baxxa u/ jew insuffiċjenza tal- qalb li sejra għall- agħar
In post-marketing safety surveillance, isolated, idiosyncratic cases of hypotension and/ or worsening heart failure have been reported in patients with impaired cardiac function, in which a causal relationship to cinacalcet could not be completely excluded and may be mediated by reductions in serum calcium levels.
3 Fl- immonitorjar tas- sigurtà ta 'wara t- tqegħid fuq is- suq, każijiet iżolati, idjosinkratiċi ta' pressjoni baxxa u/ jew insuffiċjenza tal- qalb li sejra għall- agħar, ġew rrappurtati f 'pazjenti b' indeboliment fil - funzjoni tal- qalb, f’ kazijiet fejn relazzjoni każwali ma 'cinacalcet ma' setgħetx tiġi eskluża kompletament u li setgħet tiġi kkawżata minn tnaqqis fil- livelli tal- kalċju fis- serum.
Clinical trial data showed hypotension occurred in 7% of cinacalcet-treated patients, 12% of placebo-treated patients, and heart failure occurred in 2% of patients receiving cinacalcet or placebo.
Tagħrif minn studji kliniċi wrew li kien hemm pressjoni baxxa f '7% ta' pazjenti li ngħataw cinacalcet, fi 12% ta 'pazjenti li ngħataw plaċebo, u insuffiċjenza tal- qalb seħħet f' i 2% ta' pazjenti li ngħataw cinacalcet jew plaċebo.
Parareg treatment should not be initiated in patients with a serum calcium (corrected for albumin) below the lower limit of the normal range.
Kura b’ Parareg għandha tinbeda f’ pazjenti b’ kalċju fis- serum (ikkoreġut għall- albumina) taħt il- limitu l- aktar baxx tal- firxa normali.
In CKD patients receiving dialysis who were administered Parareg, 4% of serum calcium values were less than 7.5 mg/ dl (1.875 mmol/ l).
F’ pazjenti b’ CKD li jkunu qed jirċievu d- dijalisi li ngħataw Parareg, 4% tal- valuri tal- kalċju fis- serum, kienu inqas minn 7. 5 mg/ dl (1. 875 mmol/ l).
If hypocalcaemia persists, reduce the dose or discontinue administration of Parareg..
Jekk l- ipokalċimja tippersisti, naqqas id- doża jew waqqaf l - għotja ta ’ Parareg.
If PTH levels decrease below the recommended target range in patients treated with Parareg, the dose of Parareg and/ or vitamin D sterols should be reduced or therapy discontinued.
Jekk il- livelli ta ’ PTH jonqsu taħt il- firxa mmirati rakkomandata f’ pazjenti kkurati b’ Parareg, id- doża ta ’ Parareg u/ jew sterols ta ’ Vitamina D għandhom jiġu mnaqqsa jew it- terapija titwaqqaf ġħal kollox.
In a clinical study of ESRD patients on dialysis, free testosterone levels decreased by a median of 31.3% in the Mimpara-treated patients and by 16.3% in the placebo-treated patients after 6 months of treatment.
Fi studju kliniku ta ’ pazjenti b’ ESRD fuq id- dijalisi, il- livelli ta ’ testosterone ħieles naqsu b’ medjan ta ’ 31. 3% fil- pazjenti kkurati b’ Parareg u b’ 16. 3% fil- pazjenti kkurati bil- plaċebo wara 6 xhur ta ’ kura.
An open-label extension of this study showed no further reductions in free and total testosterone concentrations over a period of 3 years in Mimpara-treated patients.
Estensjoni open- label ta ’ dan l- istudju ma wrietx aktar tnaqqis fil- konċentrazzjoni ta ’ testosterone ħieles u fil- konċentrazzjoni tat- testosterone totali fuq perijodu ta ’ 3 snin f ’ pazjenti kkurati b ’ Parareg.
Due to the potential for 2 to 4 fold higher plasma levels of cinacalcet in patients with moderate to severe hepatic impairment (Child-Pugh classification), Parareg should be used with caution in these patients and treatment should be closely monitored (see sections 4.2 and 5.2).
Minħabba l- potenzjal ta ’ livelli ta ’ cinacalet fil- plażma darbtejn sa 4 darbiet ogħla f’ pazjenti b’ insuffiċjenza epatika minn moderata għal severa (klassifikazzjoni Child- Pugh), Parareg għandu jintuża b’ kawtela f’ dawn il- pazjenti u l- kura għandha tiġi sorveljata mill- viċin (ara sezzjonijiet 4. 2 u 5. 2).
Caution should be exercised when administering Parareg concomitantly with strong inhibitors or inducers of CYP3A4 and/ or CYP1A2.
Għandha tintuża kawtela meta Parareg tingħata flimkien ma ’ inibituri jew indutturi qawwija ta ’ CYP3A4 u/ jew ta ’ CYP1A2.
Dose adjustment of Parareg may be necessary (see section 4.5).
Jista ’ jkun hemm bżonn ta ’ aġġustament fid- doża ta ’ Parareg (ara sezzjoni 4. 5).
Caution should be exercised when Parareg is administered with individually titrated, narrow therapeutic index medications that are predominantly metabolised by CYP2D6.
4 Għandha tintuża kawtela meta Parareg tingħata ma ’ mediċini, ttitrati individwalment li għandhom indiċi terapewtiku dejjaq u li huma metabolizzati pimarjament minn CYP2D6.
Dose adjustment of Parareg may be required if a patient receiving Parareg initiates or discontinues therapy with a strong inhibitor (e. g. ketoconazole, itraconazole, telithromycin, voriconazole, ritonavir) or inducer (eg rifampicin) of this enzyme (see Section 4.4).
Jista ’ jkun hemm bżonn ta ’ aġġustament fid- doża ta ’ Parareg jekk pazjent li qed jieħu Parareg jibda jew iwaqqaf terapija b’ inibitur qawwi (e. ż. ketoconazole, itraconazole, telithromycin, voriconazole, ritonavir) jew induttur qawwi (eg rifampicin) ta ’ din l- enżima (ara sezzjoni 4. 4).
Dose adjustments of concomitant medicinal products may be required when Parareg is administered with individually titrated, narrow therapeutic index substances that are predominantly metabolised by CYP2D6 (e. g., flecainide, propafenone, metoprolol given in heart failure, desipramine, nortriptyline, clomipramine) (see section 4.4).
Jista ’ jkun hemm bżonn ta ’ aġġustament fid- doża ta ’ mediċini ttitrati individwalment, li għandhom indiċi terapewtiku dejjaq u li huma metabolizzati pimarjament minn CYP2D6 (e. ż., flecainide, propafenone, metoprolol mogħti f’ każijiet ta ’ insuffiċjenza tal- qalb, desipramine, nortriptyline, clomipramine) meta dawn jingħataw flimkien ma ’ Parareg (ara sezzjoni 4. 4).
These data suggest that cinacalcet would not affect the pharmacokinetics of those classes of drugs that are metabolized by CYP3A4 and CYP3A5, such as certain immunosuppressants, including cyclosporine and tacrolimus.
Dan it- tagħrif
5 4.6 Pregnancy and lactation
5 jissuġġerixxi li cinacalcet ma jaffettwax il- farmakokinetika ta ’ dawk il- klassijiet ta ’ mediċini li huma mmetabolizzati minn CYP3A4 u CYP3A5, bħal ċertu immunosopressanti, inkluż cyclosporine u tacrolimus.
Parareg should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.
Parareg għandu jintuża fit- tqala biss jekk il - benefiċċju potenzjali jiġġustifika ir- riskju potenzjali għall- fetu.
Following careful benefit/ risk assessment, a decision should be made to discontinue either breast-feeding or treatment with Parareg.
Wara valutazzjoni b’ attenzjoni tal- benefiċċju u r- riskju, għandha tittieħed deċiżjoni jekk jitwaqqafx it- treddigħ jew titwaqqafx il- kura b ’ Parareg.
Data presented from controlled studies include 656 patients who received Parareg and 470 patients who received placebo for up to 6 months.
Tagħrif ippreżentat minn studji kkontrollati jinkludi 656 pazjent li rċevew Parareg u 470 pazjent li rċevew plaċebo sa 6 xhur.
The most commonly reported undesirable effects were nausea and vomiting, occurring in 31% Parareg and 19% placebo treated patients, and 27% Parareg and 15% placebo treated patients, respectively.
L- aktar effetti mhux mixtieqa irrappurtati b’ mod komuni kienu tqalligħ u rimettar, li dehru f’ 31% tal- pazjenti kkurati b’ Parareg u f’ 19% tal- pazjent kkurati bil- plaċebo u f’ 27% tal - pazjenti kkurati b’ Parareg u fi 15% tal- pazjenti kkurati bil- plaċebo rispettivament.
The safety profile of Parareg in these patient populations is generally consistent with that seen in patients with Chronic Kidney Disease.
Il- profil ta ’ sigurtà ta ’ Parareg f’ dawn il- popolazzjonijiet ta ’ pazjenti ġeneralment huwa konsistenti ma ’ dak li deher f’ pazjenti b’ Mard Kroniku tal- Kliewi.
Overdosage of Parareg may lead to hypocalcaemia.
Doża eċċessiva ta ’ Parareg tista ’ twassal għal ipokalċimja.
PTH levels in Parareg clinical trials were measured at the end of the dosing interval.
Il- livelli ta ’ PTH fil- provi kliniċi b’ Parareg tkejjlu fl- aħħar ta ’ l - intervall tad- dożaġġ.
Demographic and baseline characteristics were representative of the dialysis patient population with secondary HPT.
Karatteristiċi demografiċi u tal- linja bażi kienu rappreżentattivi tal- popolazzjoni ta ’ pazjenti fuq dijalisi b’ HPT
Mean baseline iPTH concentrations across the 3 studies were 733 and 683 pg/ ml (77.8 and 72.4 pmol/ l) for the cinacalcet and placebo groups, respectively.
Konċetrazzjonijiet medji tal- linja bażi ta ’ iPTH tul it- tlett studji kienu 733 u 683 pg/ ml (77. 8 u 72. 4 pmol/ l) għall- gruppi ta ’ cinacalcet u plaċebo, rispettivament.
These studies show that CKD patients not undergoing dialysis treated with cinacalcet have an increased risk for hypocalcaemia compared with cinacalcet-treated ESRD patients receiving dialysis, which may be due to lower baseline calcium levels.
Dawn l- istudji juru li pazjenti b’ CKD li mhux qegħdin fuq id- dijalisi li jingħataw cinacalcet għandhom riskju akbar ta ’ ipokalċimja meta mqabbla ma ’ pazjenti b’ ESRD li qed jirċievu d- dijalisi li jingħataw cinacalcet, li jista ’ jkun minħabba livelli ta ’ kalċju fil- linja bażi aktar baxxi u/ jew il- preżenza ta 'fdal ta' funzjoni tal- kliewi.
In a key study,46 patients (29 with parathyroid carcinoma and 17 with primary HPT (who had failed or had contraindications to parathyroidectomy) received cinacalcet for up to 3 years (mean of 328 days for patients with parathyroid carcinoma and mean of 347 days for patients with primary HPT)..
Fi studju kruċjali, 46 pazjent (29 b’ karċinoma tal- paratirojde u 17 b’ HPT primarja (li kienu fallew jew li kellhom kontra- indikazzjonijiet għall- paratirojdektomija) irċevew cinacalcet sa 3 snin (medja ta ’ 328 ġurnata għall- pazjenti b’ karċinoma tal- paratirojde u medja ta ’ 347 ġurnata għall- pazjenti b’ HPT primarja).
In patients with parathyroid carcinoma, mean serum calcium declined from 14.1 mg/ dl to 12.4 mg/ dl (3.5 mmol/ l to 3.1 mmol/ l), while in patients with primary HPT, serum calcium levels declined from 12.7 mg/ dl to 10.4 mg/ dl (3.2 mmol/ l to 2.6 mmol/ l).
Il- mira pimarja ta ’ l- istudju kienet tnaqqis tal- kalċju fis- serum ta ’ ≥ 1 mg/ dL (≥ 0. 25 mmol/ l). F’ pazjenti b’ karċinoma tal- paratirojde, il- medja tal- kalċju fis- serum naqset minn 14. 1 mg/ dl għal 12. 4 mg/ dl (3. 5 mmol/ l għal 3. 1 mmol/ l), filwaqt li f’ pazjenti b’ HPT primarja, l- livelli ta ’ kalċju fis- serum naqsu minn 12. 7 mg/ dl għal 10. 4 mg/ dl (3. 2 mmol/ l għal 2. 6 mmol/ l).
After oral administration of Parareg, maximum plasma cinacalcet concentration is achieved in approximately 2 to 6 hours.
Wara għotja orali ta ’ Parareg, konċentrazzjoni massima fil- plażma ta ’ cinacalcet tintlaħaq f’ madwar sagħtejn sa 6 sigħat.
Administration of Parareg with food results in an approximate 50 – 80% increase in cinacalcet bioavailability.
Għotja ta ’ Parareg ma ’ l- ikel wasslet għal żieda ta ’ madwar 50 – 80% fil - biodisponibilità ta ’ cinacalcet.
The AUC and Cmax of cinacalcet increase approximately linearly over the dose range of 30 to 180 mg once daily.
8 linejari fuq il- firxa ta ’ dożi ta ’ 30 sa 180 mg darba kuljum.
The pharmacokinetics of cinacalcet does not change over time.
Il- farmakokinetika ta ’ cinacalcet ma tinbidilx maż- żmien.
Cataracts and lens opacities were observed in the repeat dose rodent toxicology and carcinogenicity studies, but were
Cinacalcet intwera li jaqsam il- barriera tal- plaċenta fil- fniek.
9 not observed in dogs or monkeys or in clinical studies where cataract formation was monitored.
9 Cinacalcet ma wera l- ebda potenzjal ġenotossiku jew karċinoġeniku.
Cataracts are known to occur in rodents as a result of hypocalcaemia.
Il- marġini ta ’ siġurtà minn studji tossikoloġiċi huma żgħar minħabba ipokalċimja li tillimita d- doża osservata f’ mudelli ta ’ annimali.
Opacode Black, printing ink:
(Hypromellose, macrogol)
(Hypromellose, macrogol) (Shellac glaze (shellac), iron oxide black (E172)
(Shellac glaze (shellac), iron oxide iswed (E172)
Parareg 60 mg film-coated tablets.
Parareg 60 mg pilloli miksija b’ rita.
Reduction of hypercalcaemia in patients with: • parathyroid carcinoma. • primary HPT for whom parathyroidectomy would be indicated on the basis of serum calcium levels (as defined by relevant treatment guidelines), but in whom parathyroidectomy is not clinically appropriate or is contraindicated.
Tnaqqis ta ’ iperkalċimja f’ pazjenti b ’: • karċinoma fil- paratirojde. • HPT primarja fejn paratirojdektomija għanda tkun indikata fuq il- bażi tal- livelli tal- kalċju fis - serum (kif definit mil- linji gwida ta ’ kura rilevanti), iżda fejn paratirojdektomija mhiex klinikament xierqa jew kontraindikata.
12 PTH should be measured 1 to 4 weeks after initiation or dose adjustment of Parareg.
12 PTH għandu jitkejjel minn ġimgħa sa 4 ġimgħat wara l- bidu tal- kura jew aġġustament fid- doża ta ’ Parareg.
The dosage of Parareg should be titrated every 2 to 4 weeks through sequential doses of 30 mg twice daily, 60 mg twice daily, 90 mg twice daily, and 90 mg three or four times daily as necessary to reduce serum calcium concentration to or below the upper limit of normal.
Id- dożaġġ ta ’ Parareg għandu jiġi ttitrat kull ġimgħatejn sa 4 ġimgħat permeżż ta ’ dożi sekwenzjali ta ’ 30 mg darbtejn kuljum, 60 mg darbtejn kuljum, 90 mg darbtejn kuljum, u 90 mg tlieta jew erba ’ darbiet kuljum, kif neċessarju biex jitnaqqas il- konċetrazzjoni ta ’ kalċju fis- serum sa jew inqas mil- limitu ta ’ fuq tan- normal.
13 Hypotension and/ or worsening heart failure
Pressjoni baxxa u/ jew insuffiċjenza tal- qalb li sejra għall- agħar
In post-marketing safety surveillance, isolated, idiosyncratic cases of hypotension and/ or worsening heart failure have been reported in patients with impaired cardiac function, in which a causal relationship to cinacalcet could not be completely excluded and may be mediated by reductions in serum calcium levels.
13 Fl- immonitorjar tas- sigurtà ta 'wara t- tqegħid fuq is- suq, każijiet iżolati, idjosinkratiċi ta' pressjoni baxxa u/ jew insuffiċjenza tal- qalb li sejra għall- agħar, ġew rrappurtati f 'pazjenti b' indeboliment fil - funzjoni tal- qalb, f’ każijiet fejn relazzjoni każwali ma 'cinacalcet ma' setgħetx tiġi eskluża kompletament u li setgħet tiġi kkawżata minn tnaqqis fil- livelli tal- kalċju fis- serum.
Clinical trial data showed hypotension occurred in 7% of cinacalcet-treated patients, 12% of placebo-treated patients, and heart failure occurred in 2% of patients receiving cinacalcet or placebo.
Tagħrif minn studji kliniċi wrew li kien hemm pressjoni baxxa f '7% ta' pazjenti li ngħataw cinacalcet, fi12% ta 'pazjenti li ngħataw plaċebo, u insuffiċjenza tal- qalb seħħet f' i 2% ta' pazjenti li ngħataw cinacalcet jew plaċebo.
If hypocalcaemia persists, reduce the dose or discontinue administration of Parareg.
Jekk l- ipokalċimja tippersisti, naqqas id- doża jew waqqaf l - għotja ta ’ Parareg.
Investigational studies have shown that CKD patients not on dialysis treated with cinacalcet have an increased risk for hypocalcaemia (serum calcium levels < 8.4 mg/ dl [2.1 mmol/ l]) compared with cinacalcet-treated CKD patients on dialysis, which may be due to lower baseline calcium levels and/ or the presence of residual kidney function.
Studji investigattivi wrew li pazjenti b 'CKD li mhux qed jirċievu d- dijalisi li ngħataw cinacalcet għandhom riskju ogħla għal ipokalċimja (livelli ta' kalċju fis- serum < 8. 4 mg/ dl [2. 1 mmol/ l]) meta mqabbla ma 'pazjenti b' CKD li qed jirċievu d- dijalisi u li ngħataw cinacalcet. Dan jista 'jkun minħabba livelli ta ’ kalċju fil - linja bażi aktar baxxi u/ jew il- preżenza ta' fdal ta 'funzjoni fil- kliewi.
Caution should be exercised when Parareg is administered with individually titrated, narrow therapeutic index medications that are predominantly metabolised by CYP2D6.
14 Għandha tintuża kawtela meta Parareg tingħata ma ’ mediċini, ttitrati individwalment li għandhom indiċi terapewtiku dejjaq u li huma metabolizzati pimarjament minn CYP2D6.
Dose adjustments of concomitant medicinal products may be required when Parareg is administered with individually titrated, narrow therapeutic index substances that are predominantly metabolised by CYP2D6 (e. g., flecainide, propafenone, metoprolol given in heart failure, desimipramine, nortriptyline, clomipramine) (see section 4.4).
Jista ’ jkun hemm bżonn ta ’ aġġustament fid- doża ta ’ mediċini ttitrati individwalment, li għandhom indiċi terapewtiku dejjaq u li huma metabolizzati pimarjament minn CYP2D6 (e. ż., flecainide, propafenone, metoprolol mogħti f’ każijiet ta ’ insuffiċjenza tal- qalb, desipramine, nortriptyline, clomipramine) meta dawn jingħataw flimkien ma ’ Parareg (ara sezzjoni 4. 4).
15 4.6 Pregnancy and lactation
15 jissuġġerixxi li cinacalcet ma jaffettwax il- farmakokinetika ta ’ dawk il- klassijiet ta ’ mediċini li huma mmetabolizzati minn CYP3A4 u CYP3A5, bħal ċertu immunosopressanti, inkluż cyclosporine u tacrolimus.
Demographic and baseline characteristics were representative of the dialysis patient population with secondary HPT.
Karatteristiċi demografiċi u tal- linja bażika kienu rappreżentattivi tal- popolazzjoni ta ’ pazjenti fuq id- dijalisi b’ HPT
Mean baseline iPTH concentrations across the 3 studies were 733 and 683 pg/ ml (77.8 and 72.4 pmol/ l) for the cinacalcet and placebo groups, respectively.
Konċetrazzjonijiet medji tal- linja bażika ta ’ iPTH tul it- tlett studji kienu 733 u 683 pg/ ml (77. 8 u 72. 4 pmol/ l) għall- gruppi ta ’ cinacalcet u plaċebo, rispettivament.
The AUC and Cmax of cinacalcet increase approximately linearly over the dose range of 30 to 180 mg once daily.
18 linejari fuq il- firxa ta ’ dożi ta ’ 30 sa 180 mg darba kuljum.
The pharmacokinetics of cinacalcet does not change over time.
Il- farmakokinetika ta ’ cinacalcet ma tinbidilix maż- żmien.
Cataracts and lens opacities were observed in the repeat dose rodent toxicology and carcinogenicity studies, but were
Cinacalcet intwera li jaqsam il- barriera plaċentari fil- fniek.
19 not observed in dogs or monkeys or in clinical studies where cataract formation was monitored.
19 Cinacalcet ma wera l- ebda potenzjal ġenotossiku jew karċinoġeniku.
Parareg 90 mg film-coated tablets.
Parareg 90 mg pilloli miksija b’ rita.
PTH levels should be assessed at least 12 hours after dosing with Parareg.
Il- livelli ta ’ PTH jitkejjlu jiġu mkejla ta ’ l- inqas 12- il siegħa wara li ngħatat ta ’ Parareg.
22 PTH should be measured 1 to 4 weeks after initiation or dose adjustment of Parareg.
22 PTH għandu jitkejjel minn ġimgħa sa 4 ġimgħat wara l- bidu tal- kura jew aġġustament fid- doża ta ’ Parareg.
Serum calcium should be measured within 1 week after initiation or dose adjustment of Parareg.
Il- kalċju fis- serum għandu jitkejjel wara sa ġimgħa mill- bidu jew minn mindu jkun sar aġġustament fid- doża ta ’ Parareg.
After titration to the maximum dose of Parareg, serum calcium should be periodically monitored; if clinically relevant reductions in serum calcium are not maintained, discontinuation of Parareg therapy should be considered (see section 5.1).
Wara titrazzjoni sad- doża massima ta ’ Parareg, il- kalċju fis - serum għandu jiġi sorveljat perjodikament; jekk ma jinżamx tnaqqis klinikment rilevanti tal- kalċju fis - serum, għandu jiġi kkunsidrat twaqqif għal kollox tat- terapija b’ Parareg (ara sezzjoni 5. 1).
23 Hypotension and/ or worsening heart failure
Pressjoni baxxa u/ jew insuffiċjenza tal- qalb li sejra għall- agħar
In post-marketing safety surveillance, isolated, idiosyncratic cases of hypotension and/ or worsening heart failure have been reported in patients with impaired cardiac function, in which a causal relationship to cinacalcet could not be completely excluded and may be mediated by reductions in serum calcium levels.
23 Fl- immonitorjar tas- sigurtà ta 'wara t- tqegħid fuq is- suq, każijiet iżolati, idjosinkratiċi ta' pressjoni baxxa u/ jew insuffiċjenza tal- qalb li sejra għall- agħar, ġew rrappurtati f 'pazjenti b' indeboliment fil - funzjoni tal- qalb, f’ każijiet fejn relazzjoni każwali ma 'cinacalcet ma' setgħetx tiġi eskluża kompletament u li setgħet tiġi kkawżata minn tnaqqis fil- livelli tal- kalċju fis- serum.
Caution should be exercised when Parareg is administered with individually titrated, narrow therapeutic index medications that are predominantly metabolised by CYP2D6.
24 Għandha tintuża kawtela meta Parareg tingħata ma ’ mediċini, ttitrati individwalment li għandhom indiċi terapewtiku dejjaq u li huma metabolizzati pimarjament minn CYP2D6.
Dose adjustment of Parareg may be required if a patient receiving Parareg initiates or discontinues therapy with a strong inhibitor (e. g. ketoconazole, itraconazole, telithromycin, voriconazole, ritonavir) or inducer (eg rifampicin) of this enzyme (see Section 4.4).
Jista ’ jkun hemm bżonn ta ’ aġġustament fid- doża ta ’ Parareg jekk pazjent li qed jieħu Parareg jibda jew iwaqqaf terapija b’ inibitur qawwi( e. ż. ketoconazole, itraconazole, telithromycin, voriconazole, ritonavir) jew induttur qawwi (eg rifampicin) ta ’ din l- enżima (ara sezzjoni 4. 4).
25 4.6 Pregnancy and lactation
25 jissuġġerixxi li cinacalcet ma jaffettwax il- farmakokinetika ta ’ dawk il- klassijiet ta ’ mediċini li huma mmetabolizzati minn CYP3A4 u CYP3A5, bħal ċertu immunosopressanti, inkluż cyclosporine u tacrolimus.
The most commonly reported undesirable effects were nausea and vomiting, occurring in 31% Parareg and 19% placebo treated patients, and 27% Parareg and 15% placebo treated patients, respectively.
L- aktar effetti mhux mixtieqa irrappurtati b’ mod komuni kienu tqalligħ u rimettar, li dehru f’ 31% tal- pazjenti kkurati b’ Parareg u f’ 19% tal- pazjent kkurati bil- plaċebo, u f’ 27% tal - pazjenti kkurati b’ Parareg u fi 15% tal- pazjenti kkurati bil- plaċebo, rispettivament.
The AUC and Cmax of cinacalcet increase approximately linearly over the dose range of 30 to 180 mg once daily.
28 linejari fuq il- firxa ta ’ dożi ta ’ 30 sa 180 mg darba kuljum.
29 not observed in dogs or monkeys or in clinical studies where cataract formation was monitored.
29 Cinacalcet ma wera l- ebda potenzjal ġenotossiku jew karċinoġeniku.
Minervum 7061 4817 ZK Breda The Netherlands
Minervum 7061 4817 ZK Breda The Netherlands
The MAH must ensure that the system of pharmacovigilance, as described in version 2.1 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Id- Detentur ta ’ l- Awtorizzazjoni għat- Tqegħid fuq is- Suq (MAH) għandu jassigura li s- sistema ta ’ Farmakoviġilanza, kif dettaljata fil- verżjoni 2. 1 ippreżentata f’ Modulu 1. 8. 1. ta ’ l- Applikazzjoni għal l- Awtorizzazjoni għat- Tqegħid fis- Suq, qegħdha f’ postha u qed taħdem qabel u waqt li l- prodott qiegħed fuq is- suq.
Parareg 30 mg film-coated tablets Cinacalcet
Parareg 30 mg pilloli miksija b’ rita Cinacalcet
EU/ 1/ 04/ 293/ 001 – carton of 14 tablets EU/ 1/ 04/ 293/ 002 – carton of 28 tablets EU/ 1/ 04/ 293/ 003 – carton of 84 tablets
EU/ 1/ 04/ 293/ 001 – Kaxxa b’ 14 – il pillola EU/ 1/ 04/ 293/ 002 – Kaxxa bi 28 pillola EU/ 1/ 04/ 293/ 003 – Kaxxa bi 84 pillola
Parareg 30 mg tablet Cinacalcet
Parareg 30 mg pillola Cinacalcet
EU/ 1/ 04/ 293/ 004
EU/ 1/ 04/ 292/ 001 – Kaxxa b’ 14 – il pillola EU/ 1/ 04/ 292/ 002 – Kaxxa bi 28 pillola EU/ 1/ 04/ 292/ 003 - Kaxxa bi 84 pillola
Parareg 60 mg film-coated tablets Cinacalcet
Parareg 60 mg pilloli miksija b’ rita Cinacalcet
EU/ 1/ 04/ 293/ 005 – carton of 14 tablets EU/ 1/ 04/ 293/ 006 – carton of 28 tablets EU/ 1/ 04/ 293/ 007 – carton of 84 tablets
EU/ 1/ 04/ 292/ 005 – Kaxxa b’ 14 – il pillola EU/ 1/ 04/ 292/ 006 – Kaxxa bi 28 pillola EU/ 1/ 04/ 292/ 007 - Kaxxa bi 84 pillola
Parareg 60 mg tablet Cinacalcet
Parareg 60 mg pillola Cinacalcet
Parareg 90 mg film-coated tablets Cinacalcet
Parareg 90 mg pilloli miksija b’ rita Cinacalcet
EU/ 1/ 04/ 293/ 009 – carton of 14 tablets EU/ 1/ 04/ 293/ 010 – carton of 28 tablets EU/ 1/ 04/ 293/ 011 – carton of 84 tablets
EU/ 1/ 04/ 292/ 009 – Kaxxa b’ 14 – il pillola EU/ 1/ 04/ 292/ 010 – Kaxxa bi 28 pillola EU/ 1/ 04/ 292/ 011 - Kaxxa bi 84 pillola
Parareg 90 mg tablet Cinacalcet
Parareg 90 mg pillola Cinacalcet
Parareg 30 mg film-coated tablets Parareg 60 mg film-coated tablets Parareg 90 mg film-coated tablets Cinacalcet
Parareg 30 mg pilloli miksija b’ rita Parareg 60 mg pilloli miksija b’ rita Parareg 90 mg pilloli miksija b’ rita Cinacalcet
What Parareg is and what it is used for 2.
X’ inhu Parareg u għalxiex jintuża 2.
Before you take Parareg 3.
Qabel ma tieħu Parareg 3.
How to take Parareg 4.
Kif għandek tieħu Parareg 4.
Possible side effects 5 How to store Parareg 6.
Kif taħżen Parareg 6.
WHAT PARAREG IS AND WHAT IT IS USED FOR
X’ INHU PARAREG U GĦALXIEX JINTUŻA
Parareg works by controlling the levels of parathyroid hormone (PTH), calcium and phosphorous in your body.
Parareg jaħdem billi jikkontrolla l- livelli ta ’ l- ormon tal- paratirojde (PHT), tal- kalċju u tal- fosforu fil - ġisem tiegħek.
Parareg is used: • to treat secondary hyperparathyroidism in patients with kidney disease on dialysis. • to reduce high levels of calcium in the blood (hypercalcaemia) in patients with parathyroid cancer • to reduce high levels of calcium in the blood (hypercalcaemia) in patients with primary hyperparathyroidism who still have high calcium levels after removal of the parathyroid gland or when removal of the gland is not possible.
Parareg jintuża: • għall- kura ta ’ iperparatirojdiżmu sekondarju f’ pazjenti b’ mard tal- kliewi fuq dijalisi. • biex inaqqas livelli għolja ta ’ kalċju fid- demm (iperkalċimja) f’ pazjenti b’ kanċer tal- paratirojde • biex inqqas livelli għolja ta ’ kalċju fid- demm (iperkalċimja) f’ pazjenti b’ iperparatirojdiżmu primarju li għad għandhom livelli għolja ta ’ kalċju fid- demm wara t- tneħħija tal- glandola tal - paratirojde jew meta tneħħija tal- glandola mhix possibbli.
BEFORE YOU TAKE PARAREG
QABEL MA TIEĦU PARAREG
Do not take Parareg:
Tieħux Parareg
• DO NOT take Parareg if you are allergic (hypersensitive) to cinacalcet or any of the other ingredients of Parareg.
• TIEĦUX Parareg jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal cinacalcet jew sustanzi oħra ta ’ Parareg.
58 Before you start taking Parareg, tell your doctor if you have or have ever had
58 Oqgħod attent ħafna b’ Parareg
The risk of having seizures is higher if you have had them before; • liver problems
Ir- riskju li jkollok aċċessjonijiet huwa akbar jekk kellek minnhom qabel; • problemi tal- fwied
During treatment with Parareg, tell your doctor: • if you start or stop smoking, as this may affect the way Parareg works.
Waqt kura b’ Parareg, għid lit- tabib tiegħek: • jekk tibda jew tieqaf tpejjep, minħabba li dan jista ’ jaffettwa il- mod kif taħdem Parareg.
These can affect how Parareg works: • medicines used to treat skin and fungal infections (ketoconazole, itraconazole, voriconazole); • antibiotics used to treat bacterial infections (telithromycin, rifampicin); • medicine used to treat HIV infection and AIDS (ritonavir).
Dawn jistgħu jaffettwaw kif jaħdem Parareg: • mediċini wżati għall- kura ta ’ infezzjonijiet tal- ġilda u tal- fungu (ketoconazole, itraconazole, voriconazole);, ritonavir, jew rifampicin, għax dawn jistgħu jaffettwaw kif jaħdem Parareg; • anti- bijotiċi wżati għall- kura ta ’ infezzjonijiet ikkawżati mill- batterji (telithromycin, rifampicin); • mediċina wżata għall- kura ta ’ infezzjoni tal- HIV u AIDS (ritanovir),
Parareg may affect how the following work: • medicines used to treat depression (amitriptyline, desipramine, nortriptyline, clomipramine and fluvoxamine); • medicines used to treat changes in heart rate (flecainide and propafenone); • medicine used to treat high blood pressure (metoprolol when given in heart failure), • antibiotic used to treat bacterial infections (ciprofloxacin).
Parareg jista ’ jaffettwa kif jaħdmu dawn li ġejjin: • mediċini wżati għall- kura tad- depressjoni (amitriptyline, desipramine, nortriptyline, clomipramine u fluvoxamine); • mediċini wżati għall- kura ta ’ tibdil fir- rata tal- qalb (flecainide u propafenone); • mediċini wżati għall- kura ta ’ pressjoni għolja tad- demm (metoprolol meta mogħti għall - insuffiċjenza tal- qalb); • anti- bijotiċi wżati għall- kura ta ’ infezzjonijiet ikkawżati mill- batterji (ciprofloxacin).
Taking Parareg with food and drink
Meta tieħu Parareg ma ’ l- ikel u max- xorb
Parareg should be taken with or shortly after food.
Parareg għandu jittieħed ma ’ l- ikel jew eżatt wara l- ikel.
Parareg has not been tested in pregnant women.
Parareg ma ġiex studjat f’ nisa tqal.
In case of pregnancy, your doctor may decide to modify your treatment, as Parareg might harm the foetus..
F’ każ ta ’ tqala, it- tabib tiegħek jista ’ jiddeċidi li jimmodifika il- kura tiegħek, minħabba li Parareg tista ’ tagħmel ħsara lill- fetu.
It is not known whether Parareg is excreted in human milk.
Mhux magħruf jekk Parareg joħroġx fil- ħalib uman.
Your doctor will discuss with if you should discontinue either breast-feeding or treatment with Parareg.
It- tabib tiegħek ser jiddiskuti miegħek jekk għandekx twaqqaf it- treddigħ jew il- kura b’ Parareg.
Parareg should not affect your ability to drive and use machines.
Parareg m’ għandux jaffettwa l- ħila tiegħek biex issuq u tħaddem magni.
However, it is advisable to wait and see how you feel after taking Parareg and before driving or operating machinery.
Madanakollu huwa rrakkomandat li tistenna u tara kif tħossok wara li tieħu Parareg, qabel ma issuq jew tħaddem magni.
HOW TO TAKE PARAREG
KIF GĦANDEK TIEĦU PARAREG
59 Children under the age of 18 must not take Parareg.
Tfal taħt l- età ta ’ 18- il sena m’ għandhomx jieħdu Parareg.
Always take Parareg exactly as your doctor has told you.
Dejjem għandek tieħu Parareg skond il- parir tat- tabib.
Your doctor will tell you how much Parareg you must take.
It- tabib tiegħek ser jgħidlek kemm għandek tieħu Parareg.
Parareg must be taken orally, with or shortly after food.
Parareg għandu jittieħed mill- ħalq, ma ’ l- ikel jew ftit wara l- ikel.
The usual starting dose for Parareg is 30 mg (one tablet) once per day.
Ġeneralment id- doża tal- bidu ta ’ Parareg hija 30 mg (pillola waħda) darba kuljum.
The usual starting dose for Parareg is 30 mg (one tablet) twice per day.
Ġeneralment id- doża tal- bidu ta ’ Parareg hija 30 mg (pillola waħda) darbtejn kuljum.
If you take more Parareg than you should
Jekk tieħu Parareg aktar milli suppost
If you take more Parareg than you should you must contact your doctor immediately.
Jekk tieħu aktar Parareg milli suppost għandek tkellem lit- tabib tiegħek minnufih.
If you forget to take Parareg
Jekk tinsa tieħu Parareg
If you have forgotten a dose of Parareg, you should take your next dose as normal.
Jekk insejt doża ta ’ Parareg, għandek tieħu d- doża li jmiss bħas- soltu.
Like all medicines, Parareg can have side effects, although not everybody gets them.
Bħal kull mediċina oħra, Parareg jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Very common side effects (seen in more than 1 in 10 people taking Parareg): • nausea and vomiting, these side effects are normally quite mild and do not last for long.
Effetti sekondarji komuni ħafna (osservati f’ aktar minn 1 minn kull 10 persuni li jieħdu Parareg): • tqalligħ u rimettar, dawn l- effetti sekondarji normalment huma ħfief u ma jdumux ħafna.
Common side effects (seen in more than 1 in 100 people taking Parareg): • dizziness • numbness or tingling sensation (paraesthesia) • loss of appetite (anorexia) • muscle pain (myalgia) • weakness (asthenia) • rash • reduced testosterone levels
Effetti sekondarji komuni (osservati f’ aktar minn 1 minn kull 100 persuna li jieħdu Parareg): • sturdament • sensazzjoni ta ’ tnemnim jew tingiż (parasteżija) • telf ta ’ l- aptit (anoressija) • uġigħ fil- muskoli (majalġja) • debbulizza (astenja) • raxx • tnaqqis fil- livelli ta ’ testosterone
Uncommon side effects (seen in more than 1 in 1000 people taking Parareg): • seizures • indigestion (dyspepsia) • diarrhoea • allergic reaction (hypersensitivity)
60 Effetti sekondarji mhux komuni (osservati f’ aktar minn 1 minn kull 1000 persuna li jieħdu Parareg): • aċċessjoniiet • indiġestjoni (dispepsja) • dijarea • reazzjoni allerġika (sensittività eċċessiva)
After taking Parareg a very small number of patients with heart failure had worsening of their condition.
Wara li ħadu Parareg numru żgħir ħafna ta ’ pazjenti b 'insuffiċjenza tal- qalb kellhom irkadar tal - kundizzjoni.
As so few cases have been seen it is not known whether they are due to Parareg, or not.
Peress li ġew osservati numru hekk żgħir ta ’ każijiet, mhux magħruf jekk dawn humiex minħabba Parareg, jew le.
HOW TO STORE PARAREG
KIF TAĦŻEN PARAREG
This medicinal product does not require any special storage conditions
Dan il- prodott mediċinali ma jeħtieġx kundizzjonijiet speċjali għall- ħażna.
Do not use Parareg after the expiry date which is stated on the outer carton and on the blister.
Tużax Parareg wara d- data ta ’ skadenza li tidher fuq il- kaxxa ta ’ barra u fuq il- folja wara JIS.
(or) Do not use Parareg after the expiry date which is stated on the outer carton and on the bottle.
(jew) Tużax Parareg wara d- data ta ’ skadenza li tidher fuq il- kaxxa ta ’ barra u fuq il- flixkun
What Parareg contains
X’ fih Parareg:
The other ingredients are: • Pre-gelatinised maize starch • Microcrystalline cellulose • Povidone • Crospovidone • Magnesium stearate • Colloidal anhydrous silica.
Is- sustanzi l- oħra huma: • Pre- gelatinised maize starch • Microcrystalline cellulose • Povidone • Crospovidone • Magnesium stearate • Colloidal anhydrous silica.
The printing ink contains: shellac glaze, iron oxide black (E172).
Il- linka għall- istampar fiha: shellac glaze, iron oxide iswed (E172).
What Parareg looks like and contents of the pack
61 Id- Dehra tal- prodott u d- daqs tal- pakkett:
Parareg is a light green film-coated tablet.
Parareg hija pillola ħadra ċara, miksija b’ rita.
Parareg is available in blisters of 30 mg, 60 mg or 90 mg film-coated tablets.
Parareg huwa disponibbli f’ folji b’ pilloli miksija b’ rita ta ’ 30 mg, 60 mg jew 90 mg.
61 Parareg is available in bottles of 30 mg, 60 mg or 90 mg film-coated tablets, inside a carton.
Parareg huwa disponibbli fi fliexken b’ pilloli miksija b’ rita ta ’ 30 mg, 60 mg jew 90 mg, ġo kartuna.
SUMMARY OF PRODUCT CHARACTERISTICS 1.
KARATTERISTIĊI TAL- PRODOTT FIL- QOSOR
Paxene 6 mg/ ml concentrate for solution for infusion.
Paxene 6 mg/ ml konċentrat għal soluzzjoni għall- infużjoni.
One vial contains 6 mg/ ml of paclitaxel (30 mg of paclitaxel in 5 ml or 100 mg of paclitaxel in 16.7 ml or 150 mg of paclitaxel in 25 ml or 300 mg of paclitaxel in 50 ml).
Fjala waħda biss li fiha 6 mg/ ml ta ’ paclitaxel (30 mg ta ’ paclitaxel f’ 5 ml jew 100 mg ta ’ paclitaxel f’ 16. 7 ml jew 150 mg ta ’ paclitaxel f’ 25 ml jew 300 mg ta ’ paclitaxel f’ 50 ml).
For excipients, see 6.1.
Għal- lista kompleta ta ’ sustanzi mhux attivi, ara sezzjoni 6. 1.
Paxene is a clear, colourless to slightly yellow, viscous solution.
Paxene huwa soluzzjoni viskuża, ċara, mingħajr kulur li tagħti kemmxejn fl- isfar.
Paxene is indicated for the treatment of patients with: – advanced AIDS-related Kaposi’ s sarcoma (AIDS-KS) who have failed prior liposomal anthracycline therapy – metastatic carcinoma of the breast (MBC) who have failed, or are not candidates for standard anthracycline-containing therapy – advanced carcinoma of the ovary (AOC) or with residual disease (> 1 cm) after initial laparotomy, in combination with cisplatin as first-line treatment – metastatic carcinoma of the ovary (MOC) after failure of platinum-containing combination therapy without taxanes as second-line treatment – non-small cell lung carcinoma (NSCLC) who are not candidates for potentially curative surgery and/ or radiation therapy, in combination with cisplatin.
Paxene huwa intiż għal kura ta ’ pazjenti b ’: sarkoma ta ’ Kaposi avvanzata, relatata ma ’ l- AIDS (KS- AIDS) f’ każijiet fejn terapija – liposomali b’ anthracycline ma tkunx ħadmet fuqhom karsinoma fl- istadju metastatiku fis- sider (MBC) li ma tikkwalifikawx għal terapija – standard li fiha anthracycline jew f’ każijiet fejn din il- kura ma tkunx ħadmet – karsinoma ta ’ l- ovarju avvanzata (AOC) jew bi fdal marradi (> 1 ċm) wara laparotomija tal - bidu, flimkien ma ’ ciplatin bħala l- kura preferita – karsinoma fl- istadju metastatiku fl- ovarju (MOC) meta t- terapija kombinata li fiha platinu mingħajr taxanes ma tkunx ħadmet, bħala t- tieni kura preferuta _ karsinoma non- small cell lung (NSCLC) li ma tikkwalifikawx għal kirurġija li hija potenzjalment kurattiva u/ jew terapija ta ’ radjazzjoni, u tingħata flimkien ma ’ cisplatin.
Limited efficacy data supports this indication, a summary of the relevant studies is shown in section 5.1.
Tagħrif ristrett dwar l- effikaċja jissostanza din l- indikazzjoni, kif muri bil- ġabra ta ’ l- istudji rilevanti murija f’ sezzjoni 5. 1
Paxene should only be administered under the supervision of a qualified oncologist in units specialised in the administration of cytotoxic agents (see 6.6).
Paxene għandu jingħata biss taħt is- superviżjoni ta ’ onkoloġista kwalifikat f’ taqsimiet speċjalizzati fl - għoti ta ’ sustanzi ċitotossiċi (ara 6. 6)
All patients must be pre-medicated with corticosteroids, antihistamines and H2 antagonists prior to Paxene.
Qabel ma jingħata Paxene l- pazjenti kollha għandhom jingħataw kura b’ kortikosterojdi, anti- istamini u antagonisti ta’ l- H2.
The following is a recommended premedication regimen: dexamethasone (8 - 20 mg) given orally (12 and 6 hours) or intravenously (30-60 mins) prior to Paxene, chlorpheniramine 10 mg intravenously or an equivalent antihistamine 30 to 60 minutes before Paxene and cimetidine (300 mg) or ranitidine (50 mg) intravenously 30 to 60 minutes before Paxene.
Reġimen rakkomandat li jista ’ jingħata huwa: dexamethasone (8- 20 mg) mogħti mill- ħalq (12- il siegħa u 6 sigħat) jew minn ġol- vina (30- 60 minuta) qabel Paxene, chlorphenadrine 10 mg mogħti ġol- vina jew xi anti- istamin ekwivalenti mogħti minn 30 sa 60 minuta qabel Paxene u cimetidine (300 mg) jew rantidine (50 mg) ġol- vina mogħti minn 30 sa 60 minuta qabel Paxene.
Appropriate supportive medications should be readily available in case of severe hypersensitivity reactions.
Mediċina ta ’ appoġġ adattata għandha tkun disponibbli f’ każ li jkun hemm reazzjonijiet serji ta ’ sensittività eċċessiva.
Paxene should be administered via an infusion control device (pump) using non-PVC tubing and connectors.
2 Paxene għandu jingħata b' tagħmir li jikkontrolla l- infużjoni (pompa) bl- użu ta ’ konnetturi u pajpijiet li m’ humiex tal- PVC.
An in-line filter with a microporous membrane not greater than 0.22 µm should be attached to the intravenous tubing during infusion of Paxene (see 6.6).
Filtru b' membrana mikroporuża mhux akbar minn 0. 22 µm għandu jitwaħħal fil - pajp li jidħol ġol- vina waqt l- infużjoni ta ’ Paxene (ara sezzjoni 6. 6).