qanastek/EMEA-V3 huggingface dataset:
Inflammation of the salivary gland; decreases in the number of cells in the blood, including low red and white blood cell count, low platelet count (thrombocytopenia); serious allergic reactions; (e. g. hypersensitivity, anaphylactic reaction), inflammation of blood vessels (vasculitis necrotising), decreased or loss of appetite; restlessness, weakness, dizziness; blurred or yellowing of vision; inflamed pancreas, upset stomach; yellowing of the skin or eyes (jaundice); skin disorders such as inflamed blood vessels in the skin, increased sensitivity to sunlight, or blistering and peeling of the top layer of skin (toxic epidermal necrolysis); kidney inflammation or impaired kidney function; fever; impaired electrolyte balance, high blood cholesterol levels, decreased blood volume, glucose in the urine (glycosuria), increased levels of glucose, uric acid, or fat in the blood.
Infjammazzjoni tal- glandola tal- bżieq; tnaqqis fin- numru ta ’ ċelluli fid- demm, li jinkludu għadd baxx taċ- ċelluli tad- demm ħomor u taċ- ċelluli tad- demm bojod, għadd baxx tal- plejtlets (tromboċitopenija); reazzjonijiet allerġiċi serji (eż. sensittività eċċessiva, reazzjoni anafilattika), infjammazzjoni tal- vini jew arterji (vaskulite nekrotizzanti), tnaqqis jew telf tal- aptit; nuqqas ta ’ kwiet f’ ġismek, dgħjufija, sturdament; vista mċajpra jew tara kollox isfar; frixa infjammata, stonku mqalleb; sfurija tal- ġilda jew ta ’ l- għajnejn (suffejra); disturbi tal- ġilda bħal vini jew arterji infjammati; żieda fis- sensittività għad - dawl tax- xemx, jew infafet u tqaxxir fis- saff ta ’ fuq tal- ġilda (nekrolisi epidermali tossika); infjammazzjoni tal- kliewi jew indeboliment fil- funzjoni tal- kliewi; deni; indeboliment fil- bilanċ tal - elettroliti, livelli għolja ta ’ kolesterol fid- demm, tnaqqis fil- volum tad- demm, glucose fl- awrina (glikosurja), żieda fil- livelli tal- glucose, uric acid, jew xaħam fid- demm.
The other ingredients are lactose monohydrate, magnesium stearate, maize starch, meglumine, microcrystalline cellulose, povidone, red iron oxide (E172), sodium hydroxide, sodium starch glycollate (type A), sorbitol (E420)
73 Is- sustanzi l- oħra huma lactose monohydrate, magnesium stearate, maize starch, meglumine, microcrystalline cellulose, povidone, red iron oxide (E172), sodium hydroxide, sodium starch glycollate (type A), sorbitol (E420)
What MicardisPlus looks like and contents of the pack
Id- dehra ta ’ MicardisPlus u d- daqs tal- pakkett
MicardisPlus 80 mg/ 12.5 mg tablets are red and white, oval-shaped, two-layer tablets engraved with the company logo and the code'H8 '.
Il- pilloli MicardisPlus 80 mg/ 12. 5 mg huma ħomor u bojod, b’ forma ovali, b’ żewġ saffi, imnaqqxa bil- logo tal- kumpanija u l- kodiċi 'H8'.
MicardisPlus is available in blisters packs containing 14, 28, 30, 56, 84, 90 or 98 tablets, or unit dose blister packs containing 28 x 1 tablets.
MicardisPlus hu disponibbli f’ pakketti tal- folji li fihom 14, 28, 30, 56, 84, 90 jew 98 pillola, jew pakketti tal- folji bid- doża ta ’ l- unità li fihom 28 x 1 pillola.
74 For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Għal kull tagħrif dwar din il- mediċina, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq.
Tel: +34 93 404 58 00
74 Tel: +34 93 404 58 00
76 PACKAGE LEAFLET:
75 FULJETT TA ’ TAGĦRIF:
Do not take MicardisPlus • if you are allergic (hypersensitive) to telmisartan or any other ingredients included in MicardisPlus tablets (see “ Further Information” for a list of other ingredients). • if you are allergic (hypersensitive) to hydrochlorothiazide or to any other sulfonamide-derived medicines. • during the last six months of pregnancy (see section Pregnancy and breast-feeding) • if you are breast-feeding. • if you have severe liver problems such as cholestasis or biliary obstruction (problems with drainage of the bile from the gall bladder), or any other severe liver disease. • if you have severe kidney disease.
Tiħux MicardisPlus • jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal telmisartan jew għal xi sustanzi oħra fil- pilloli MicardisPlus (ara “ Tagħrif addizzjonali ” għal- lista ta ’ sustanzi oħra). • jekk int allerġiku/ a (tbati minn sensittività eċċessiva) għal hydrochlorothiazide jew għal xi mediċini oħrajn derivati minn sulfonamide. • matul l- aħħar sitt xhur tat- tqala (ara s- sezzjoni Tqala u treddigħ).
77 • if your doctor determines that you have low potassium levels or high calcium levels in your blood that do not get better with treatment.
76 • jekk qed tredda ’. • jekk għandek problemi severi tal- fwied bħal kolestasi jew ostruzzjoni biljari (problemi fit - tnixxija tal- bila mill- bużżieqa tal- marrara) jew kwalunkwe mard sever ieħor tal- fwied. • jekk għandek mard sever tal- kliewi. • jekk it- tabib tiegħek jistabbilixxi li għandek livelli baxxi ta ’ potassium jew livelli għolja ta ’ calcium fid- demm li ma jitjibux bil- kura.
tablets'), laxatives (e. g. castor oil), corticosteroids (e. g. prednisone), ACTH (a hormone), amphotericin (an antifungal medicine), carbenoxolone (used to treat mouth ulcers), penicillin G sodium (an antibiotic), and salicylic acid and derivatives.
('pilloli tal- awrina'), lassattivi (eż. castor oil), kortikosterojdi (eż. prednisone), ACTH (ormon), amphotericin (mediċina antifungali), carbenoxolone (jintuża għall- kura ta ’ ulċeri tal- ħalq), penicillin G sodium (antibijotiku), u salicylic acid u derivattivi tiegħu.
The usual dose of MicardisPlus is one tablet a day.
78 Id- doża normali hi ta ’ pillola waħda darba kuljum.
79 If you take more MicardisPlus than you should If you accidentally take too many tablets, contact your doctor, pharmacist, or your nearest hospital emergency department immediately.
Jekk tieħu MicardisPlus aktar milli suppost Jekk aċċidentalment tieħu pilloli żejda, ikkuntattja lit- tabib jew lill- ispiżjar tiegħek, jew lill- eqreb dipartiment ta ’ l- emerġenza immedjatament.
Decreased blood potassium levels; anxiety; fainting (syncope); sensation of tingling, pins and needles (paraesthesia); feeling of spinning (vertigo); fast heart beat (tachycardia), heart rhythm disorders, low blood pressure, a sudden fall in blood pressure when you stand up; shortness of breath (dyspnoea); symptoms of an upset stomach such as diarrhoea; dry mouth; flatulence; back pain, muscle spasm, muscle pain; erectile dysfunction (inability to get or keep an erection); chest pain; increased blood uric acid levels. Rare side effects may include:
Tnaqqis fil- livelli tal- potassium fid- demm; ansjetà; ħass ħażin (sinkope); sensazzjoni ta ’ tnemnim, sensazzjoni bħal qisu xi ħadd qed iniggżek bil- labar (parestesija); tħoss kollox idur bik (vertigo); taħbit tal- qalb mgħaġġel (takikardija), disturbi fir- ritmu tat- taħbit tal- qalb, pressjoni tad- demm baxxa, il - pressjoni tad- demm taqa ’ f’ daqqa meta tkun bilwieqfa; qtugħ ta ’ nifs (dispneja); sintomi ta ’ stonku mqalleb bħal dijarea; ħalq xott, gass; uġigħ fid- dahar, spażmi fil- muskoli, uġigħ fil- muskoli; disfunzjoni erettili (ma tkunx kapaċi jkollok jew iżżomm erezzjoni); uġigħ fis- sider, żieda fil- livelli tal- uric acid fid- demm.
Telmisartan In patients taking telmisartan alone the following additional side effects have been reported:
79 Telmisartan F’ pazjenti li kienu qed jieħdu telmisartan waħdu, l- effetti sekondarji addizzjonali li ġejjin kienu rrappurtati:
80 Side effects of unknown frequency may include:
Effetti sekondarji ta ’ frekwenza mhux magħrufa jistgħu jinkludu:
Inflammation of the salivary gland; decreases in the number of cells in the blood, including low red and white blood cell count, low platelet count (thrombocytopenia); serious allergic reactions (e. g. hypersensitivity, anaphylactic reaction), inflammation of blood vessels (vasculitis necrotising); decreased or loss of appetite; restlessness, weakness, dizziness; blurred or yellowing of vision; inflamed pancreas, upset stomach; yellowing of the skin or eyes (jaundice); skin disorders such as inflamed blood vessels in the skin, increased sensitivity to sunlight, or blistering and peeling of the top layer of skin (toxic epidermal necrolysis); kidney inflammation or impaired kidney function; fever; impaired electrolyte balance, high blood cholesterol levels, decreased blood volume, glucose in the urine (glycosuria), increased levels of glucose, uric acid, or fat in the blood.
Infjammazzjoni tal- glandola tal- bżieq; tnaqqis fin- numru ta ’ ċelluli fid- demm, li jinkludu għadd baxx taċ- ċelluli tad- demm ħomor u taċ- ċelluli tad- demm bojod, għadd baxx tal- plejtlets (tromboċitopenija); reazzjonijiet allerġiċi serji (eż. sensittività eċċessiva, reazzjoni anafilattika), infjammazzjoni tal- vini jew arterji (vaskulite nekrotizzanti), tnaqqis jew telf tal- aptit; nuqqas ta ’ kwiet f’ ġismek, dgħjufija, sturdament; vista mċajpra jew tara kollox isfar; frixa infjammata, stonku mqalleb; sfurija tal- ġilda jew ta ’ l- għajnejn (suffejra); disturbi tal- ġilda bħal vini jew arterji infjammati; żieda fis- sensittività għad - dawl tax- xemx, jew infafet u tqaxxir fis- saff ta ’ fuq tal- ġilda (nekrolisi epidermali tossika); infjammazzjoni tal- kliewi jew indeboliment fil- funzjoni tal- kliewi; deni; indeboliment fil- bilanċ tal - elettroliti, livelli għolja ta ’ kolesterol fid- demm, tnaqqis fil- volum tad- demm, glucose fl- awrina (glikosurja), żieda fil- livelli tal- glucose, uric acid, jew xaħam fid- demm.
The other ingredients are lactose monohydrate, magnesium stearate, maize starch, meglumine, microcrystalline cellulose, povidone, yellow iron oxide (E172), sodium hydroxide, sodium starch glycollate (type A), sorbitol (E420)
80 Is- sustanzi l- oħra huma lactose monohydrate, magnesium stearate, maize starch, meglumine, microcrystalline cellulose, povidone, yellow iron oxide (E172), sodium hydroxide, sodium starch glycollate (type A), sorbitol (E420)
MicardisPlus 80 mg/ 25 mg tablets are yellow and white, oval-shaped, two-layer tablets engraved with the company logo and the code'H9 '.
Il- pilloli MicardisPlus 80 mg/ 25 mg huma sofor u bojod, b’ forma ovali, b’ żewġ saffi, imnaqqxa bil - logo tal- kumpanija u l- kodiċi 'H9'.
MicardisPlus is available in blister packs containing 14, 28, 30, 56, 90 or 98 tablets, or unit dose blister packs containing 28 x 1 tablets
MicardisPlus hu disponibbli f’ pakketti tal- folji li fihom 14, 28, 30, 56, 90 jew 98 pillola, jew pakketti tal- folji bid- doża ta ’ l- unità li fihom 28 x 1 pillola.
82 For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Għal kull tagħrif dwar din il- mediċina, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq.
Tel: +34 93 404 58 00
81 Tel: +34 93 404 58 00
What is Mimpara?
X' inhu Mimpara?
Mimpara is a medicine containing the active substance cinacalcet.
Mimpara huwa mediċina li fiha s- sustanza attiva cinacalcet.
It is available as light green oval tablets (30, 60 or 90 mg).
Huwa disponibbli f' pilloli ovali aħdar ċar (30, 60 u 90 mg).
What is Mimpara used for?
Għal xiex jintuża Mimpara?
Mimpara is used in adults and elderly patients: • to treat secondary hyperparathyroidism, a condition in which the parathyroid glands in the neck produce too much parathyroid hormone (PTH). ‘ Secondary ’ means that the hyperparathyroidism is caused by another condition.
Mimpara jintuża f’ pazjenti adulti u anzjani: • biex jittratta l- iperparatirojdiżmu sekondarju, kundizzjoni fejn il- glandoli tal- paratirojde fl - għonq jipproduċu wisq ormon paratirojdu (PTH). ‘ Sekondarju ’ ifisser li l- iperparatirojdiżmu huwa kkawżat minn kundizzjoni oħra.
It can lead to bone and joint pain and deformities of the arms and legs.
Jista ’ jwassal għal uġigħ fl- għadam u l- ġogi u difetti fid - dirgħajn u r- riġlejn.
Mimpara is used in patients with serious kidney disease who need dialysis to clear their blood of waste products.
Mimpara jintuża f' pazjenti b' mardiet serji tal- kliewi li jkollhom bżonn ta 'dijaliżi biex id- demm jitnaddfilhom mill- prodotti żejda.
It can be used as part of treatment including phosphate binders or vitamin D sterols. • to reduce hypercalcaemia (high blood calcium levels) in patients with parathyroid carcinoma (cancer of the parathyroid glands), or in patients with primary hyperparathyroidism who cannot have their parathyroid glands removed or when the doctor thinks that removal of the parathyroid glands is not appropriate. ‘ Primary ’ means that the hyperparathyroidism is not caused by any other condition.
Jista ’ jintuża bħala parti mit- trattament li jinkludi binders tal- fosfat (phosphate binders) jew l- isterols tal- vitamina D. • biex inaqqas l- iperkalċemija (livelli għoljin tal- kalċju fid- demm) f’ pazjenti li jkollhom
How is Mimpara used?
Kif jintuża Mimpara?
In secondary hyperparathyroidism, the recommended starting dose for adults is 30 mg once a day.
Fl- iperparatirojdiżmu sekondarju, id- doża tal- bidu rakkomandata għall- adulti hi ta '30 mg darba kuljum.
The dose is adjusted every two to four weeks, according the patient ’ s PTH levels, up to a maximum of 180 mg once a day.
Id- doża tiġi aġġustata bejn kull ġimagħtejn u kull erba 'ġimgħat, skond il- livelli ta' PTH tal - pazjent, sa massimu ta '180 mg darba kuljum.
PTH levels should be assessed at least 12 hours after dosing and one to four weeks after each dose adjustment of Mimpara.
Il- livelli tal- PTH għandhom jiġu eżaminati ta 'l- inqas 12- il siegħa wara d- doża u bejn ġimgħa u erba' ġimgħat wara kull aġġustament ta 'Mimpara.
Blood calcium levels should be measured frequently, and within one week of each dose adjustment of Mimpara.
Il- livelli tal- kalċju fid- demm għandhom jitkejlu ta 'spiss, u fi żmien ġimgħa minn kull aġġustament tad- doża ta' Mimpara.
Once a maintenance dose has been established, calcium levels should be measured monthly and PTH levels should be measured every one to three months.
La tiġi stabbilita doża ta ’ manutenzjoni, il- livelli tal- kalċju għandhom jitkejlu kull xahar u l - livelli PTH għandhom jitkejlu bejn kull xahar sa tliet xhur.
In patients with parathyroid carcinoma or primary hyperparathyroidism, the recommended starting dose of Mimpara for adults is 30 mg twice a day.
F’ pazjenti bil- karċinoma tal- paratirojde jew iperparatirojdiżmu primarju, id- doża inizjali rakkomandata ta 'Mimpara għall- adulti hi ta' 30 mg darbtejn kuljum.
The dose of Mimpara should be increased every two to four weeks up to 90 mg three or four times a day as necessary to reduce blood calcium to normal levels.
Id- doża ta 'Mimpara għandha tiġi miżjuda bejn kull ġimagħtejn u erba' ġimgħat sa 90 mg tlieta jew erba 'darbiet kuljum kif meħtieġ biex jonqsu l- livelli tal- kalċju fid- demm għal- livelli normali.
Mimpara is taken with food or shortly after a meal.
Mimpara jittieħed ma 'l- ikel jew ftit wara l- ikel.
(44-20) 74 18 84 00 Fax (44-20) 74 18 86 68 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 86 68 E- mail: mail@ emea. eu. int http: // www. emea. europa. eu
How does Mimpara work?
Kif jaħdem Mimpara?
The active substance in Mimpara, cinacalcet, is a calcimimetic agent.
Is- sustanza attiva f’ Mimpara, cinacalcet, hija aġent kalċimimetiku.
This means that it mimics the action of calcium in the body.
Dan ifisser li jaħdem bħal kif jaħdem il- kalċju fil- ġisem.
Cinacalcet works by increasing the sensitivity of the calcium-sensing receptors on the parathyroid glands that regulate PTH secretion.
Cinacalcet jaħdem billi jżid fis- sensittività tar- riċetturi li jagħarfu l- kalċju fuq il- glandoli tal- paratirojde li jirregolaw it- tneħħija ta ’ PTH.
By increasing the sensitivity of these receptors, cinacalcet leads to a reduction in the production of PTH by the parathyroid glands.
Iż- żieda minn cinacalcet fis- sensittività ta ’ dawn ir- riċetturi twassal għat- tnaqqis fil- produzzjoni ta ’ PTH mill- glandoli tal- paratirojd.
The reduction in PTH levels also leads to a decrease in blood calcium levels.
It- tnaqqis tal- livelli ta ’ PTH iwassal ukoll għal tnaqqis fil- livelli tal- kalċju fid- demm.
How has Mimpara been studied?
Kif ġie studjat Mimpara?
Mimpara has been studied in three main studies involving 1,136 dialysis patients with serious kidney disease.
Mimpara ġie studjat fi tliet studji ewlenin li fihom ħadu sehem 1, 136 pazjent b' mard serju tal- kliewi li kienu fuq dijaliżi.
Mimpara was compared with placebo (a dummy treatment).
Mimpara tqabbel ma 'plaċebo (trattament finta).
The studies lasted for six months.
L- istudji damu sitt xhur.
The main measure of effectiveness was the number of patients who had a PTH level below 250 micrograms per litre at the end of the study.
Il- mezz ewlieni tal- kejl ta 'l- effikaċja kien l- għadd ta' pazjenti li, fi tmiem l- istudju, kellhom livell ta 'PTH inqas minn 250 mikrogramma kull litru.
Mimpara has also been studied in a study involving 46 patients with hypercalcaemia, including 29 with parathyroid carcinoma, and 17 with primary hyperparathyroidism who could not have their parathyroid glands removed or in whom surgery to remove the parathyroid glands was not effective.
Mimpara ġie studjat ukoll fi studju li kien jinvolvi 46 pazjent b’ iperkalċemija, li 29 minnhom kellhom karċinoma tal- paratirojde u 17 kellhom iperparatirojdiżmu primarju li ma setgħux ikollhom il- glandoli tal- paratirojde mneħħija jew li kirurġija għat- tneħħija ta ’ dawn il- glandoli ma kenitx effettiva.
The main measure of effectiveness was the number of patients who had a reduction in blood calcium levels of more than 1 mg per decilitre by the time a maintenance dose had been found (between two and 16 weeks after the start of the study).
Il- kejl ewlieni ta ’ l- effikaċja kien l- għadd ta ’ pazjenti li kellhom tnaqqis fil- livelli tal- kalċju fid- demm ta ’ iktar minn 1 mg/ deċilitru sa meta d- doża ta ’ żamma kienet ġiet stabbilita (bejn ġimgħatejn u 16- il ġimgħa wara l- bidu ta ’ l- istudju).
The study continued for over three years.
L- istudju kompla għal aktar minn tliet snin.
A further three studies compared the effectiveness of Mimpara and placebo in a total of 136 patients with primary hyperparathyroidism over up to a year.
Minn dawn.
Of these, 45 went on to a fourth, long-term study looking at the effectiveness of Mimpara over a total of almost six years.
45 komplew għar- raba ’ studju fuq tul ta ’ żmien twil, b’ ħarsa lejn l- effikaċja ta ’ Mimpara għal total ta ’ kważi sitt snin.
What benefit has Mimpara shown during the studies?
X' inhuma l- benefiċċji ta 'Mimpara li ntwerew f' dawn l- istudji?
In dialysis patients with serious kidney disease, about 40% of the patients taking Mimpara 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 Mimpara 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.
Mimpara brought about a 42% reduction in PTH levels compared with an increase of 8% in patients taking placebo.
Mimpara wera tnaqqis ta ’ madwar 42% fil - livelli tal- PTH meta mqabbel ma ’ żieda ta ’ 8% f’ pazjenti li ħadu plaċebo.
Mimpara 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).
Mimpara rriżulta 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 Mimpara for hypercalcaemia in patients with primary hyperparathyroidism.
Ir- riżultati ta ’ l- istudji addizzjonali kienu favorevoli għall- użu ta ’ Mimpara fit- trattament ta ’ iperkalċemija fil- pazjenti b’ iperparatirojdiżmu primarju.
What is the risk associated with Mimpara?
X' inhu r- riskju assoċjat ma 'Mimpara?
The most common side effects with Mimpara in secondary hyperparathyroidism (seen in more than 1 patient in 10) are nausea (feeling sick) and vomiting.
L- effetti sekondarji l- aktar komuni b' Mimpara f’ iperparatirojdiżmu sekondarju (li dehru f' aktar minn pazjent 1 minn 10) huma nawżea (dardir) u remettar.
In patients with parathyroid carcinoma or primary hyperparathyroidism, the side effects are similar to those seen in patients with long-standing kidney disease - the most frequent side effects are nausea and vomiting.
Fil- pazjenti b' kanċer tal- paratirojde jew iperparatirojdiżmu primarju, l- effetti sekondarji kienu simili għal dawk ta ’ pazjenti li kienu ilhom ibatu bil- mard tal- kliewi - l- iktar effetti sekondarji komuni kienu n- nawżea u r- remettar.
For the full list of all side effects reported with Mimpara, see the Package Leaflet.
Għal- lista sħiħa ta 'l- effetti sekondarji irrappurtati f' Mimpara, ara l- Fuljett ta 'Tagħrif.
Mimpara should not be used in people who may be hypersensitive (allergic) to cinacalcet or any of the other ingredients.
Mimpara ma għandux jintuża minn persuni li huma sensittivi żżejjed (allerġiċi) għal cinacalcet jew għal xi sustanza oħra tiegħu.
Why has Mimpara been approved?
Għaliex ġie approvat Mimpara?
The Committee for Medicinal Products for Human Use (CHMP) decided that Mimpara’ 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 ’ Mimpara 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 Mimpara be given marketing authorisation.
Il- Kumitat irrakkomanda li Mimpara jingħata awtorizzazzjoni għat- tqegħid fis- suq.
2/ 3 Other information about Mimpara:
Tagħrif ieħor dwar Mimpara:
The European Commission granted a marketing authorisation valid throughout the European Union for Mimpara to Amgen Europe B. V. on 22 October 2004.
Il- Kummissjoni Ewropea tat l- awtorizzazzjoni għat- tqegħid fis- suq għal Mimpara valida fl- Unjoni Ewropea kollha lil Amgen Europe B. V. fit- 22 ta 'Ottubru ta' l- 2004.
The full EPAR for Mimpara is available here.
L- EPAR sħiħ għal Mimpara jista ’ jiġi kkonsultat hawn.
Mimpara 30 mg film-coated tablets.
Mimpara 30 mg pilloli miksija b’ rita.
Each tablet contains 30 mg cinacalcet (as hydrochloride).
Kull pillola fiha 30 mg cinacalcet (bħala hydrochloride).
Light green, oval, film-coated tablets marked “ AMGEN” on one side and “ 30” on the other.
Pilloli miksija b’ rita, ħodor ċari, ovali mmarkati b ’ “ AMGEN ” fuq naħa u “ 30 ” fuq in- naħa l - oħra.
Treatment of secondary hyperparathyroidism (HPT) in patients with end-stage renal disease (ESRD) on maintenance dialysis therapy.
Kura ta ’ iperparatirojdiżmu sekondarju (HPT) f’ pazjenti b’ mard renali ta ’ l- aħħar stadju (ESRD) fuq terapija ta ’ manutenzjoni b’ dijalisi.
Mimpara may be used as part of a therapeutic regimen including phosphate binders and/ or Vitamin D sterols, as appropriate (see section 5.1).
Mimpara jista ’ jintuża bħala parti minn kors terapewtiku li jinkludi binders ta ’ fosfati u/ jew sterols ta ’ Vitamina D, kif xieraq (ara sezzjoni 5. 1).
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 għandha 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.
It is recommended that Mimpara 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 Mimpara 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.
No change in starting dose is necessary.
Mhux neċessarju tibdil fid- doża tal- bidu.
Mimpara 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).
Mimpara 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
Adults and elderly (> 65 years)
Adulti u anzjani (> 65 sena)
The recommended starting dose for adults is 30 mg once per day.
Id- doża rakkomandata tal- bidu għall- adulti hija ta ’ 30 mg darba kuljum.
Mimpara 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.
Mimpara 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 Mimpara.
Il- livelli ta ’ PTH għandhom jitkejjlu ta ’ l- inqas 12- il siegħa wara li ngħatat Mimpara.
Reference should be made to current treatment guidelines.
Għandha ssir referenza għal- linji gwida ta ’ kura kurrenti.
2 PTH should be measured 1 to 4 weeks after initiation or dose adjustment of Mimpara.
2 PTH għandu jitkejjel minn ġimgħa sa 4 ġimgħat wara l- bidu tal- kura jew aġġustament fid- doża ta ’ Mimpara.
PTH should be monitored approximately every 1-3 months during maintenance.
PTH għandu jitkejjel bejn wieħed u ieħor kull xahar sa 3 xhur waqt il- manutenzjoni.
Either the intact PTH (iPTH) or bio- intact PTH (biPTH) may be used to measure PTH levels; treatment with Mimpara 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’ Mimpara ma tibdilx ir- relazzjoni bejn iPTH u biPTH.
Information regarding the pharmacokinetic/ pharmacodynamic (PK/ PD) profile of cinacalcet is given in section 5.1
Informazzjoni dwar il- profil farmakokinetiku/ farmakodinamiku (PK/ PD) ta ’ cinacalcet tingħata f’ sezzjoni 5. 1
During dose titration, serum calcium levels should be monitored frequently, and within 1 week of initiation or dose adjustment of Mimpara.
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 ’ Mimpara.
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.
If serum calcium levels decrease below the normal range, appropriate steps should be taken (see section 4.4).
Jekk il- livelli ta ’ kalċju fis- serum jonqsu taħt il- livelli normali, għandhom jittieħdu passi xierqa (ara sezzjoni 4. 4).
Concomitant therapy with phosphate binders and/ or vitamin D sterols should be adjusted as appropriate.
Terapija fl- istess ħin b’ binders tal- fosfat u/ jew sterols ta ’ Vitamina D għandhom jiġu aġġustati kif xieraq.
Safety and efficacy have not been established in patients below the age of 18 years.
Is- sigurtà u l- effikaċja ma ġewx stabbiliti f’ pazjenti taħt l- età ta ’ 18- il sena.
Parathyroid Carcinoma and Primary Hyperparathyroidism
Karċinoma tal- Paratirojde u Iperparatirojdiżmu Primarju
The recommended starting dose of Mimpara for adults is 30 mg twice per day.
Id- doża tal- bidu rakkomandata ta ’ Mimpara għall- adulti hija ta ’ 30 mg darbtejn kuljum.
The dosage of Mimpara 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 ’ Mimpara 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.
The maximum dose used in clinical trials was 90 mg four times daily.
Id- doża massima użata fil- provi klinċi kienet ta ’ 90 mg erba ’ darbiet kuljum.
Serum calcium should be measured within 1 week after initiation or dose adjustment of Mimpara.
Il- kalċju fis- serum għandu jitkejjel wara ġimgħa mill- bidu jew minn mindu jkun sar aġġustament fid - doża ta ’ Mimpara.
Once maintenance dose levels have been established, serum calcium should be measured every 2 to 3 months.
Ladarba jiġu stabbiliti l- livelli tad- doża ta ’ manutenzjoni, l- kalċju fis- serum għandu jitkejjel kull xaharejn sa 3 xhur.
After titration to the maximum dose of Mimpara, serum calcium should be periodically monitored; if clinically relevant reductions in serum calcium are not maintained, discontinuation of Mimpara therapy should be considered (see section 5.1).
Wara titrazzjoni sad- doża massima ta ’ Mimpara, 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’ Mimpara (ara sezzjoni 5. 1).
Seizures
Aċċessjonijiet
In three clinical studies of Chronic Kidney Disease (CKD) patients on dialysis, five percent of the patients in both the Mimpara 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 ’ Mimpara kif ukoll fil- grupp tal- plaċebo rrappurtaw passat mediku ta ’ aċċessjonijiet fil- linja bażika.
In these studies, seizures were observed in 1.4% of Mimpara treated patients and 0.4% of placebo-treated patients.
F’ dawn l- istudji, aċċessjonijiet kienu osservati f’ 1. 4% tal- pazjenti kkurati b’ Mimpara u f’ 0. 4% fil- pazjenti kkurati bil- plaċebo.
While the basis for the reported difference in seizure rate is not clear, the threshold for seizures is lowered by significant reductions in serum calcium levels.
Filwaqt li l- bażi tad- differenża rrappurtata fir- rata ta ’ aċċessjonijiet mhix ċara, l- limitu li taħtu ma sseħx aċċessjoni huwa mnaqqas minħabba tnaqqis sinifikanti tal- livelli tal- kalċju fis- serum.
3 Hypotension and/ or worsening heart failure
3 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.
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, fi 12% ta 'pazjenti li ngħataw plaċebo, u insuffiċjenza tal- qalb seħħet fi 2% ta' pazjenti li ngħataw cinacalcet jew plaċebo.
Serum Calcium
Kalċju fis- Serum
Mimpara treatment should not be initiated in patients with a serum calcium (corrected for albumin) below the lower limit of the normal range.
Kura b’ Mimpara għandha tinbeda f’ pazjenti b’ kalċju fis- serum (ikkoreġut għall- albumina) taħt il - limitu l- aktar baxx tal- firxa normali.
Since cinacalcet lowers serum calcium, patients should be monitored carefully for the occurrence of hypocalcaemia (see section 4.2).
Minħabba li cinacalcet ibaxxi l- kalċju fis- serum, il- pazjenti għandhom jiġu sorveljati b’ attenzjoni għall- okkorrenza ta ’ ipokalċimja (ara sezzjoni 4. 2).
In CKD patients receiving dialysis who were administered Mimpara, 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 Mimpara, 4% tal- valuri tal- kalċju fis- serum, kienu inqas minn 7. 5 mg/ dl (1. 875 mmol/ l).
In the event of hypocalcaemia, calcium-containing phosphate binders, vitamin D sterols and/ or adjustment of dialysis fluid calcium concentrations can be used to raise serum calcium.
F’ każ ta ’ ipokalċimja, binders tal- fosfat li fihom il- kalċju, sterols ta ’ Vitamina D u/ jew aġġustament tal- konċetrazzjonijiet tal- kalċju fil- fluwidu tad- dijalisi jistgħu jintużaw biex jgħollu l- livelli tal- kalċju fis- serum.
If hypocalcaemia persists, reduce the dose or discontinue administration of Mimpara.
Jekk l- ipokalċimja tippersisti, naqqas id - doża jew waqqaf l- għotja ta ’ Mimpara.
Potential manifestations of hypocalcaemia may include paraesthesias, myalgias, cramping, tetany and convulsions.
Manifestazzjonijiet potenzjali ta ’ ipokalċimja jistgħu jinkldu paresteżiji, mijalġji, bugħawwiġ, tetanu u konvulżjonijiet.
Cinacalcet is not indicated for CKD patients not on dialysis.
Cinacalcet mhux indikat għal CKD f 'pazjenti li mhux qed jirċievu d- dijalisi.
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.
Dan jista 'jkun minħabba livelli ta ’ kalċju fil - linja bażi aktar baxxi u/ jew il- preżenza ta' fdal ta 'funzjoni tal- kliewi.
Adynamic bone disease may develop if PTH levels are chronically suppressed below approximately 1.5 times the upper limit of normal with the iPTH assay.
Marda ta ’ l- għadam adinamika tista ’ tiżviluppa jekk il- livelli ta ’ PTH jinżamm kronikament taħt il - livell ta ’ madwar 1. 5 drabi taħt il- limitu ta ’ fuq tan- normal b’ analiżi għal iPTH.
If PTH levels decrease below the recommended target range in patients treated with Mimpara, the dose of Mimpara 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’ Mimpara, id- doża ta ’ Mimpara u/ jew sterols ta ’ Vitamina D għandhom jiġu mnaqqsa jew it- terapija titwaqqaf ġħal kollox.
Testosterone Levels
Livelli ta ’ Testosterone
Testosterone levels are often below the normal range in patients with end-stage renal disease.
Livelli ta ’ testosterone ta ’ spiss ikunu taħt il- firxa normali f’ pazjenti b’ mard renali ta ’ l- aħħar stadju.
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’ Mimpara 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 ’ Mimpara.
The clinical significance of these reductions in serum testosterone is unknown.
Is- sinifikat kliniku ta ’ dan it- tnaqqis fit- testosterone fis- serum mhux magħruf.
Hepatic Insufficiency
Insuffiċjenza Epatika
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), Mimpara 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), Mimpara għandu jintuża b’ kawtela f’ dawn il- pazjenti u l- kura għandha tiġi sorveljata mill- viċin (ara sezzjonijiet 4. 2 u 5. 2).
Interactions
Interazzjonijiet
Caution should be exercised when administering Mimpara concomitantly with strong inhibitors or inducers of CYP3A4 and/ or CYP1A2.
Għandha tintuża kawtela meta Mimpara tingħata flimkien ma ’ inibituri jew indutturi qawwija ta ’ CYP3A4 u/ jew ta ’ CYP1A2.
Dose adjustment of Mimpara may be necessary (see section 4.5).
Jista ’ jkun hemm bżonn ta ’ aġġustament fid- doża ta ’ Mimpara (ara sezzjoni 4. 5).
Caution should be exercised when Mimpara is administered with individually titrated, narrow therapeutic index medications that are predominantly metabolised by CYP2D6.
4 Għandha tintuża kawtela meta Mimpara tingħata ma ’ mediċini, ttitrati individwalment li għandhom indiċi terapewtiku dejjaq u li huma metabolizzati pimarjament minn CYP2D6.
Dose adjustments of concomitant medications may be necessary (see section 4.5).
Jista ’ jkun hemm bżonn ta ’ aġġustament fid- doża tal- mediċini li jingħataw fl- istess ħin (ara sezzjoni 4. 5).
4 Plasma levels of cinacalcet may be lower in smokers due to induction of CYP1A2-mediated metabolism.
Il- livelli ta ’ cinacalcet fil- plażma jistgħu jkunu inqas f’ min ipejjep minħabba l- induzzjoni ta ’ metaboliżmu medjat minn CYP1A2.
Dose adjustments may be necessary if a patient starts or stops smoking during cinacalcet treatment (see section 4.5).
Jista ’ jkun hemm bżonn ta ’ aġġustament fid- doża jekk il- pazjent jibda jew jieqaf ipejjep waqt il- kura b’ cinacalcet (ara sezzjoni 4. 5).
Effect of other medications on cinacalcet
Effetti ta ’ mediċini oħra fuq cinacalcet
Cinacalcet is metabolised in part by the enzyme CYP3A4.
Cinacalcet huwa metabolizzat parzjalment mill- enżima CYP3A4.
Co-administration of 200 mg bid ketoconazole, a strong inhibitor of CYP3A4, caused an approximate 2-fold increase in cinacalcet levels.
L- għotja konkomitanti ta ’ 200 mg bid ketoconazole, inibitur qawwi ta ’ CYP3A4, wasslet għal żieda ta ’ madwar darbtejn fil- livelli ta ’ cinacalcet.
Dose adjustment of Mimpara may be required if a patient receiving Mimpara 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 ’ Mimpara jekk pazjent li qed jieħu Mimpara 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).
In vitro data indicate that cinacalcet is in part metabolised by CYP1A2.
Tagħrif in vitro jindika li cinacalcet huwa parzjalment metabolizzat minn CYP1A2.
Smoking induces CYP1A2; the clearance of cinacalcet was observed to be 36-38% higher in smokers than non-smokers.
It- tipjip jinduċi CYP1A2; it- tneħħija ta ’ cinacalcet instabet li kienet 36- 38% ogħla f’ min ipejjep meta mqabbla ma ’ dawk li ma jpejpux.
The effect of CYP1A2 inhibitors (e. g. fluvoxamine, ciprofloxacin) on cinacalcet plasma levels has not been studied.
L- effett ta ’ inibituri ta ’ CYP1A2 (e. ż. fluvoxamine, ciprofloxacin) fuq il- livelli ta ’ cinacalcet fil- plażma ma ġiex studjat.
Dose adjustment may be necessary if a patient starts or stops smoking or when concomitant treatment with strong CYP1A2 inhibitors is initiated or discontinued.
Jista ’ jkun hemm bżonn ta ’ aġġustament fid- doża jekk pazjent jibda jew jieqaf ipejjep jew meta tinbeda jew titwaqqaf għal kollox kura fl- istess ħin b’ inibituri qawwija ta ’ CYP1A2.
Calcium carbonate:
Calcium carbonate:
Co-administration of calcium carbonate (single 1500 mg dose) did not alter the pharmacokinetics of cinacalcet.
L- għotja konkomitanti ta ’ calcium carbonate (doża waħda ta ’ 1500 mg) ma affettwatx il- farmakokinetika ta ’ cinacalcet.
Co-administration of sevelamer (2400 mg tid) did not affect the pharmacokinetics of cinacalcet.
L- għotja konkomitanti ta ’ sevelamer (2400 mg tid)) ma affettwatx il- farmakokinetika ta ’ cinacalcet.
Co-administration of pantoprazole (80 mg od) did not alter the pharmacokinetics of cinacalcet.
L- għotja konkomitanti ta ’ pantoprazole (80 mg od)) ma affettwatx il- farmakokinetika ta ’ cinacalcet.
Effect of cinacalcet on other medications
Effetti ta ’ cinacalcet fuq mediċini oħra
Medicinal products metabolised by the enzyme P450 2D6 (CYP2D6):
Prodotti mediċinali metabolizzati mill- enżima P450 2D6 (CYP2D6):
Cinacalcet is a strong inhibitor of CYP2D6.
Cinacalcet huwa inibitur qawwi ta ’ CYP2D6.
Dose adjustments of concomitant medicinal products may be required when Mimpara 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 ’ Mimpara (ara sezzjoni 4. 4).
Desipramine:
Desipramine:
Concurrent administration of 90 mg cinacalcet once daily with 50 mg desipramine, a tricyclic antidepressant metabolised primarily by CYP2D6, significantly increased desipramine exposure 3.6-fold (90% CI 3.0, 4.4) in CYP2D6 extensive metabolisers.
L- għotja ta ’ 90 mg cinacalcet darba kuljum flimkien ma ’ 50 mg desipramine, antidepressanti triċikliċi metabolizzat primarjament minn CYP2D6, żiedet b’ mod sinifikanti l - espożizzjoni ta ’ desipramine bi 3. 6 darbiet (90% CI 3. 0, 4. 4) f’ metabolizzaturi estensivi ta ’ CYP2D6.
Multiple oral doses of cinacalcet did not affect the pharmacokinetics or pharmacodynamics (as measured by prothrombin time and clotting factor VII) of warfarin.
Dożi mutlipli orali ta ’ cinacalcet ma affettwawx il- farmakokinetika jew il - farmakodinamika (kif imkejla mill- ħin prothrombin u l- fattur li jgħaqqad id- demm VII) ta ’ warfarin.
The lack of effect of cinacalcet on the pharmacokinetics of R- and S-warfarin and the absence of auto- induction upon multiple dosing in patients indicates that cinacalcet is not an inducer of CYP3A4, CYP1A2 or CYP2C9 in humans.
In- nuqqas ta ’ effett ta ’ cinacalcet fuq il- farmakokinetika ta ’ R - u S- warfarin u n- nuqqas ta ’ awto - induzzjoni wara dożaġġ multiplu f’ pazjenti jindika li cinacalcet mhux induttur ta ’ CYP3A4, CYP1A2 jew CYP2C9 fil- bnedmin.
Co-administration of cinacalcet (90 mg) with orally administered midazolam (2 mg), a CYP3A4 and CYP3A5 substrate, did not alter the pharmacokinetics of midazolam.
L- għotja ta ’ cinacalcet (90 mg) flimkien ma ’ midazolam (2 mg) mogħti b’ mod orali, substrat ta ’ CYP3A4 u CYP3A5, ma biddlitx il- farmakokinetika ta ’ midazolam.
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 jissuġġerixxi li cinacalcet ma jaffettwax il- farmakokinetika ta ’ dawk il- klassijiet ta ’ mediċini li huma
5 4.6 Pregnancy and lactation
5 mmetabolizzati minn CYP3A4 u CYP3A5, bħal ċertu immunosopressanti, inkluż cyclosporine u tacrolimus.
There are no clinical data from the use of cinacalcet in pregnant women.
M’ hemmx tagħrif kliniku dwar l- użu ta ’ cinacalcet waqt it- tqala.
Animal studies do not indicate direct harmful effects with respect to pregnancy, parturition or postnatal development.
Studji fuq il- bhejjem ma jurux effetti ta ’ ħsara diretti fuq it- tqala, ħlas jew żvilupp wara t- twelid.
No embryonal/ foetal toxicities were seen in studies in pregnant rats and rabbits with the exception of decreased foetal body weights in rats at doses associated with maternal toxicities (see section 5.3).
Ma dehru l- ebda tossiċitajiet fl - embriju/ fetu fi studji li saru b’ firien u fniek tqal bl- eċċeżżjoni ta ’ tnaqqis fil- piż tal- fetu b’ dożi assoċjati ma ’ tossiċitajiet fl- omm (ara sezzjoni 5. 3).
Mimpara should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.
Mimpara għandu jintuża fit- tqala biss jekk il - benefiċċju potenzjali jiġġustifika ir- riskju potenzjali għall- fetu.
It is not known whether cinacalcet is excreted in human milk.
Mhux magħruf jekk cinacalcet joħroġx fil- ħalib uman.
Cinacalcet is excreted in the milk of lactating rats with a high milk to plasma ratio.
Cinacalcet joħroġ fil- ħalib ta ’ firien li jreddgħu bi proporzjon ta ’ ħalib għall- plażma għoli.
Following careful benefit/ risk assessment, a decision should be made to discontinue either breast-feeding or treatment with Mimpara.
Wara valutazzjoni b’ attenzjoni tal- benefiċċju u r- riskju, għandha tittieħed deċiżjoni jekk jitwaqqafx it- treddigħ jew titwaqqafx il- kura b ’ Mimpara.
Secondary Hyperparathyroidism
Iperparatirojdiżmu Sekondarju
Data presented from controlled studies include 656 patients who received Mimpara and 470 patients who received placebo for up to 6 months.
Tagħrif ippreżentat minn studji kkontrollati jinkludi 656 pazjent li rċevew Mimpara u 470 pazjent li rċevew plaċebo sa 6 xhur.
The most commonly reported undesirable effects were nausea and vomiting, occurring in 31% Mimpara and 19% placebo treated patients, and 27% Mimpara 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’ Mimpara u f’ 19% tal- pazjent kkurati bil- plaċebo u f’ 27% tal - pazjenti kkurati b’ Mimpara u fi 15% tal- pazjenti kkurati bil- plaċebo rispettivament.
Nausea and vomiting were mild to moderate in severity and transient in nature in the majority of patients.
Fil - maġġoranza tal- pazjenti t- tqalligħ u r- rimettar kienu ħfief sa moderati fis- severità u temporanji fin - natura.
Discontinuation of therapy as a result of undesirable effects was mainly due to nausea (1% placebo; 5% cinacalcet) and vomiting (< 1% placebo; 4% cinacalcet).
Twaqqif għal kollox tat- terapija minħabba l- effetti mhux mixtieqa kien il- biċċa l- kbira minħabba t- tqalligħ (1% plaċebo; 5% cinacalcet) u r- rimettar (< 1% placebo; 4% cinacalcet).