natgillin/translations-raw huggingface dataset:
Cinacalcet decreased iPTH and Ca x P, calcium and phosphorus levels regardless of baseline iPTH or Ca x P level, dialysis modality (PD versus HD), duration of dialysis, and whether or not vitamin D sterols were administered.
Cinakalcet je znižal iPTH, Ca x P, kalcij in fosfor ne glede na izhodiščno raven iPTH ali Ca x P, način dialize (peritonealna dializa ali hemodializa), trajanje dialize in uporabo ali neuporabo sterolov vitamina D.
Reductions in PTH were associated with non-significant reductions of bone metabolism markers (bone specific alkaline phosphatase, N-telopeptide, bone turnover and bone fibrosis).
Znižanje iPTH je bilo povezano z neznačilnimi znižanji označevalcev presnove kosti (za kosti specifične alkalne fosfataze, N- telopeptida, obrata kosti in fibroze kosti).
In post-hoc analyses of pooled data from 6 and 12 months clinical studies, Kaplan-Meier estimates of bone fracture and parathyroidectomy were lower in the cinacalcet group compared with the control group.
V post hoc analizah kumulativnih podatkov iz 6 - in 12- mesečne klinične študije so bile Kaplan- Meierjeve ocene za zlome kosti in paratiroidektomije v skupini s cinakalcetom nižje kot v kontrolni skupini.
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 and/ or the presence of residual kidney function.
Vzrok bi lahko bile nižje izhodiščne koncentracije kalcija v serumu in/ ali preostalo delovanje ledvic
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).
V ključni študiji je 46 bolnikov (29 s paratiroidnim karcinomom in 17 s primarnim hiperparatiroidizmom (pri katerih paratiroidektomija ni bila uspešna ali je bila kontraindicirana) dobivalo cinakalcet do 3 leta (povprečje pri bolnikih s paratiroidnim karcinomom je bilo 328 dni, pri bolnikih s primarnim hiperparatiroidizmom pa 347 dni).
Cinacalcet was administered at doses ranging from 30 mg twice daily to 90 mg four times daily.
Cinacalcet so dobivali v odmerkih od 30 mg dvakrat na dan do 90 mg štirikrat na dan.
The primary endpoint of the study was a reduction of serum calcium of ≥ 1 mg/ dl (≥ 0.25 mmol/ l).
Primarna končna točka študije je bilo znižanje kalcija v serumu za ≥ 1 mg/ dl (≥ 0, 25 mmol/ l).
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).
Pri bolnikih s paratiroidnim karcinomom se je povprečna koncentracija kalcija v serumu znižala s 14, 1 mg/ dl na 12, 4 mg/ dl (s 3, 5 mmol/ l na 3, 1 mmol/ l), pri bolnikih s primarnim hiperparatiroidizmom pa se je koncentracija kalcija v serumu znižala z 12, 7 mg/ dl na 10, 4 mg/ dl (s 3, 2 mmol/ l na 2, 6 mmol/ l).
Eighteen of 29 patients (62%) with parathyroid carcinoma and 15 of 17 subjects (88%) with primary HPT achieved a reduction in serum calcium of ≥ 1 mg/ dl (≥ 0.25 mmol/ l).
Osemnajstim od 29 bolnikov (62%) s paratiroidnim karcinomom in 15 od 17 preiskovancev (88%) s primarnim hiperparatiroidizmom se je kalcij v serumu znižal za ≥ 1 mg/ dl (≥ 0, 25 mmol/ l).
After oral administration of Mimpara, maximum plasma cinacalcet concentration is achieved in approximately 2 to 6 hours.
Cinakalcet doseže največjo koncentracijo v plazmi v približno 2 do 6 urah po peroralni uporabi Mimpare.
Based on between-study comparisons, the absolute bioavailability of cinacalcet in fasted subjects has been estimated to be about 20-25%.
Na podlagi primerjav med študijami ocenjujejo, da je absolutna biološka uporabnost cinakalceta pri preiskovancih na tešče okrog 20- 25%.
Administration of Mimpara with food results in an approximate 50 – 80% increase in cinacalcet bioavailability.
Zaužitje Mimpare s hrano poveča biološko uporabnost cinakalceta za približno 50 do 80%.
Steady state drug levels are achieved within 7 days with minimal accumulation.
Stanje dinamišnega ravnovesja je doseženo v 7 dneh ob minimalnem kopičenju.
At doses above 200 mg, the absorption was saturated probably due to poor solubility.
V odmerkih nad 200 mg seabsorpcija zasiti, verjetno zaradi slabe topnosti.
The pharmacokinetics of cinacalcet does not change over time.
Farmakokinetika cinakalceta se sčasoma ne spreminja.
The volume of distribution is high (approximately 1000 litres), indicating extensive distribution.
Volumen porazdelitve je velik (približno 1 000 litrov), kar kaže na obširno porazdelitev.
Cinacalcet is approximately 97% bound to plasma proteins and distributes minimally into red blood cells.
Cinakalcet je približno 97- odstotno vezan na beljakovine v plazmi in se minimalno porazdeli v eritrocite.
8 Cinacalcet is metabolised by multiple enzymes, predominantly CYP3A4 and CYP1A2 (the contribution of CYP1A2 has not been characterised clinically).
Presnova cinakalceta poteka z več encimi, pretežno s CYP3A4 in CYP1A2 (prispevek CYP1A2 klinično ni opredeljen).
Based on in vitro data, cinacalcet is a strong inhibitor of CYP2D6, but is neither an inhibitor of other CYP enzymes at concentrations achieved clinically, including CYP1A2, CYP2C8, CYP2C9, CYP2C19, and CYP3A4 nor an inducer of CYP1A2, CYP2C19 and CYP3A4.
8 Na podlagi podatkov in vitro cinakalcet močno zavira CYP2D6, a v klinično doseženih koncentracijah ne zavira drugih encimov CYP, vključno s CYP1A2, CYP2C8, CYP2C9, CYP2C19 in CYP3A4 in ne inducira CYP1A2, CYP2C19 in CYP3A4.
After administration of a 75 mg radiolabelled dose to healthy volunteers, cinacalcet was rapidly and extensively metabolised by oxidation followed by conjugation.
Po aplikaciji 75- mg radioaktivno označenega odmerka zdravim prostovoljcem se je cinakalcet hitro in izdatno presnovil z oksidacijo, ki ji je sledila konjugacija.
Renal excretion of metabolites was the prevalent route of elimination of radioactivity.
Glavna pot eliminacije radioaktivnosti je bilo izločanje presnovkov skozi ledvice.
Hepatic Insufficiency:
Insuficienca jeter:
Compared to subjects with normal liver function, average AUC of cinacalcet was approximately 2-fold higher in subjects with moderate impairment and approximately 4-fold higher in subjects with severe impairment.
V primerjavi s preiskovanci z normalnim delovanjem jeter je povprečna AUC cinakalceta pri preiskovancih z zmerno okvaro približno 2- krat večja, pri preiskovancih s hudo okvaro pa približno 4 - krat večja.
The mean half-life of cinacalcet is prolonged by 33% and 70% in patients with moderate and severe hepatic impairment, respectively.
Pri bolnikih z zmerno okvaro jeter je povprečni razpolovni čas cinakalceta podaljšan za 33% in pri bolnikih s hudo okvaro jeter za 70%.
(see sections 4.2 and 4.4).
Ker je odmerjanje titrirano za vsakega bolnika posebej glede na parametre varnosti in učinkovitosti, pri bolnikih z okvaro jeter ni potrebno dodatno prilagajanje odmerka (glejte poglavji 4. 2 in 4. 4).
Because doses are titrated for each subject, no additional dose adjustment is necessary based on gender.
Ker je odmerjanje titrirano za vsakega bolnika posebej, dodatno prilagajanje odmerka glede na spol ni potrebno.
The pharmacokinetics of cinacalcet have not been studied in patients < 18 years of age.
Farmakokinetika cinakalceta ni raziskana pri bolnikih, mlajših od 18 let.
Smoking:
Kajenje:
Clearance of cinacalcet is higher in smokers than in non-smokers, likely due to induction of CYP1A2- mediated metabolism.
Očistek cinakalceta je pri kadilcih večji kot pri nekadilcih, verjetno zaradi indukcije presnove CYP1A2.
If a patient stops or starts smoking, cinacalcet plasma levels may change and dose adjustment may be necessary.
Če bolnik neha ali začne kaditi, se koncentracija cinakalceta v plazmi lahko spremeni in potrebna utegne biti prilagoditev odmerka.
Cinacalcet was not teratogenic in rabbits when given at a dose of 0.4 times, on an AUC basis, the maximum human dose for secondary HPT (180 mg daily).
Cinakalcet za kunce ni bil teratogen v odmerku, ki je bil (na podlagi AUC) 0, 4- krat tolikšen kot največji človeški odmerek za sekundarni hiperparatiroidizem (180 mg/ dan).
The non-teratogenic dose in rats was 4.4 times, on an AUC basis, the maximum dose for secondary HPT.
Neteratogeni odmerek pri podganah je bil (na podlagi AUC) 4, 4- krat tolikšen kot največji odmerek za sekundarni hiperparatiroidizem.
There were no effects on fertility in males or females at exposures up to 4 times a human dose of 180 mg/ day (safety margins in the small population of patients administered a maximum clinical dose of 360 mg daily would be approximately half those given above).
Ob izpostavljenosti, ki je bila do 4- krat tolikšna kot pri humanem odmerku 180 mg/ dan, zdravilo ni vplivalo na plodnost samcev in samic (varnostne meje pri manjhni populaciji bolnikov, ki so dobivali največji klinični odmerek 360 mg na dan, bi bile približno pol navedene).
Cataracts and lens opacities were observed in the repeat dose rodent toxicology and carcinogenicity studies, but were
Varnostne meje, ugotovljene v toksikoloških študijah, so nizke zaradi hipokalciemije, ki omejuje odmerek in so jo opažali v živalskih modelih.
9 not observed in dogs or monkeys or in clinical studies where cataract formation was monitored.
V študijah toksičnosti pri ponavljajočih se odmerkih in študijah kancerogenega potenciala pri glodalcih so ugotavljali katarakte in motnjave leč; takšnih sprememb niso ugotovili pri psih in opicah in tudi ne v kliničnih študijah, v katerih so spremljali nastajanje katarakt.
Cataracts are known to occur in rodents as a result of hypocalcaemia.
Znano je, da se pri glodalcih zaradihipokalciemije pojavijo katarakte.
In in vitro studies, IC50 values for the serotonin transporter and KATP channels were found to be 7 and 12 fold greater, respectively, than the EC50 for the calcium-sensing receptor obtained under the same experimental conditions.
V študijah in vitro so za transporter serotonina ugotovili 7- krat večje vrednosti IC50 in za KATP- kanale 12- krat večje vrednosti IC50 kot je bila EC50 za kalcij- zaznavajoče receptorje pod enakimi eksperimentalnimi pogoji.
Tablet Core
Jedro tablete
Pre-gelatinised starch (maize) Microcrystalline cellulose Povidone Crospovidone Magnesium stearate Colloidal anhydrous silica
predgelirani škrob (koruzni) mikrokristalna celuloza povidon krospovidon magnezijev stearat brezvodni koloidni silicijev dioksid
Tablet Coat
Prevleka tablete
Carnauba Wax Opadry II green:
karnauba vosek Opadry II zelena:
(Lactose monohydrate, hypromellose, titanium dioxide (E171), glycerol triacetate, FD & C Blue (E132), iron oxide yellow (E172)
(laktoza monohidrat, hipromeloza, titanov dioksid (E171), triacetin, indigotin (E132), rumeni železov oksid (E172))
Opadry clear:
Opadry prozorna:
Opacode Black, printing ink:
Opacode Črna, črnilo za tiskanje:
(Hypromellose, macrogol) (Shellac glaze (shellac), iron oxide black (E172)
(hipromeloza, makrogol) (glazura šelaka (šelak), črni železov oksid (E172))
Bottle:
Steklenička:
Aclar/ PVC/ PVAc/ Aluminium blister containing 14 tablets.
Pretisni omot (Aclar/ PVC/ PVAc/ aluminij), ki vsebuje 14 tablet.
Pack sizes of 1 blister (14 tablets), 2 blisters (28 tablets), 6 blisters (84 tablets) per carton.
Velikosti pakiranj z 1 pretisnim omotom (14 tablet), 2 pretisnima omotoma (28 tabletami) ali 6 pretisnimi omoti (84 tabletami) na škatlico.
High Density Polyethylene (HDPE) bottle with a desiccant canister and polyester coil, and a child- resistant polypropylene cap with an induction seal, packed into a carton.
Steklenička iz polietilena velike gostote (HDPE) s sušilnim vložkom in poliesterskim navojem ter za otroke varno polipropilensko zaporko z indukcijskim pečatom, pakirana v škatlici.
Each bottle contains 30 tablets.
Vsaka steklenička vsebuje 30 tablet.
Each tablet contains 60 mg cinacalcet (as hydrochloride).
Ena tableta vsebuje 60 mg cinakalceta (v obliki klorida).
Light green, oval, film-coated tablets marked “ AMGEN” on one side and “ 60” on the other.
60 mg: svetlozelene, ovalne filmsko obložene tablete z oznako "AMGEN" na eni strani in "60" na drugi strani.
12 PTH should be measured 1 to 4 weeks after initiation or dose adjustment of Mimpara.
12 PTH je treba izmeriti od 1 do 4 tedne po začetku zdravljenja oz. prilagoditvi odmerka Mimpare.
13 Hypotension and/ or worsening heart failure
13 znižanih koncentracij kalcija v serumu.
14 Plasma levels of cinacalcet may be lower in smokers due to induction of CYP1A2-mediated metabolism.
Koncentracija cinakalceta v plazmi je pri kadilcih zaradi indukcije presnove s CYP1A2 lahko nižja.
4.5 Interaction with other medicinal products and other forms of interaction
14 4. 5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij
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, desimipramine, nortriptyline, clomipramine) (see section 4.4).
Če bolnik dobiva Mimparo hkrati z individualno titriranimi učinkovinami, ki imajo ozek terapevtski indeks in se pretežno presnavljajo s CYP2D6 (npr. flekainid, propafenon, metoprolol pri srčnem popuščanju, dezipramin, nortriptilin, klomipramin), utegne biti potrebna prilagoditev odmerka sočasno rabljenih zdravil (glejte poglavje 4. 4).
15 4.6 Pregnancy and lactation
4. 6 Nosečnost in dojenje
16 Investigations Common: hypocalcaemia (see section 4.4), reduced testosterone levels (see section 4.4)
Preiskave Pogoste: hipokalciemija (glejte poglavje 4. 4), znižana koncentracija testosterona (glejte poglavje 4. 4)
Parathyroid Carcinoma and Primary Hyperparathyroidism
16 Paratiroidni karcinom in primarni hiperparatiroidizem
17 consistent across the 3 studies.
Rezultati vseh 3 študij so se skladali.
Approximately 60% of cinacalcet-treated patients achieved a ≥ 30% reduction in iPTH levels, and this effect was consistent across the spectrum of baseline iPTH levels.
17 Približno 60% s cinakalcetom zdravljenih bolnikov je doseglo ≥ 30% znižanje vrednosti iPTH; tak učinek je bil dosleden prek spektra različnih izhodiščnih koncentracij iPTH.
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 and/ or the presence of residual kidney function.
Vzrok bi lahko bile nižje izhodiščne koncentracije kalvija v serumu in/ ali preostalo delovanje ledvic.
18 Cinacalcet is metabolised by multiple enzymes, predominantly CYP3A4 and CYP1A2 (the contribution of CYP1A2 has not been characterised clinically).
Presnova cinakalceta poteka z več encimi, pretežno s CYP3A4 in CYP1A2 (prispevek CYP1A2 klinično ni opredeljen).
Based on in vitro data, cinacalcet is a strong inhibitor of CYP2D6, but is neither an inhibitor of other CYP enzymes at concentrations achieved clinically, including CYP1A2, CYP2C8, CYP2C9, CYP2C19, and CYP3A4 nor an inducer of CYP1A2, CYP2C19 and CYP3A4.
18 Na podlagi podatkov in vitro cinakalcet močno zavira CYP2D6, a v klinično doseženih koncentracijah ne zavira drugih encimov CYP, vključno s CYP1A2, CYP2C8, CYP2C9, CYP2C19 in CYP3A4 in ne inducira CYP1A2, CYP2C19 in CYP3A4.
19 not observed in dogs or monkeys or in clinical studies where cataract formation was monitored.
V študijah toksičnosti pri ponavljajočih se odmerkih in študijah kancerogenega potenciala pri glodalcih so ugotavljali katarakte in motnjave leč; takšnih sprememb niso ugotovili pri psih in opicah in tudi ne v kliničnih študijah, v katerih so spremljali nastajanje katarakt.
Opacode Black, printing ink:
(hipromeloza, makrogol)
(Hypromellose, macrogol) (Shellac glaze (shellac), iron oxide black (E172)
(glazura šelaka (šelak), črni železov oksid (E172))
Each tablet contains 90 mg cinacalcet (as hydrochloride).
Ena tableta vsebuje 90 mg cinakalceta (v obliki klorida).
Light green, oval, film-coated tablets marked “ AMGEN” on one side and “ 90” on the other.
90 mg: svetlozelene, ovalne filmsko obložene tablete z oznako "AMGEN" na eni strani in "90" na drugi strani.
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.
Zmanjšanje hiperkalciemije pri bolnikih s: • paratiroidnim karcinomom. • primarnim hiperparatiroidizmom, pri katerih bi bila glede na koncentracijo kalcija v serumu indicirana paratiroidektomija (kot je opredeljeno v ustreznih smernicah za zdravljenje), a ta pri njih ni klinično primerna ali je kontraindicirana..
22 PTH should be measured 1 to 4 weeks after initiation or dose adjustment of Mimpara.
22 PTH je treba izmeriti od 1 do 4 tedne po začetku zdravljenja oz. prilagoditvi odmerka Mimpare.
23 Hypotension and/ or worsening heart failure
23 znižanih koncentracij kalcija v serumu.
24 Plasma levels of cinacalcet may be lower in smokers due to induction of CYP1A2-mediated metabolism.
Koncentracija cinakalceta v plazmi je pri kadilcih zaradi indukcije presnove s CYP1A2 lahko nižja.
4.5 Interaction with other medicinal products and other forms of interaction
24 4. 5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij
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 metabolizers.
3, 0, 4, 4).
25 4.6 Pregnancy and lactation
4. 6 Nosečnost in dojenje
26 Investigations Common: hypocalcaemia (see section 4.4), reduced testosterone levels (see section 4.4)
Preiskave Pogoste: hipokalciemija (glejte poglavje 4. 4), znižana koncentracija testosterona (glejte poglavje 4. 4)
Parathyroid Carcinoma and Primary Hyperparathyroidism
26 Paratiroidni karcinom in primarni hiperparatiroidizem
27 consistent across the 3 studies.
Rezultati vseh 3 študij so se skladali.
Approximately 60% of cinacalcet-treated patients achieved a ≥ 30% reduction in iPTH levels, and this effect was consistent across the spectrum of baseline iPTH levels.
27 Približno 60% s cinakalcetom zdravljenih bolnikov je doseglo ≥ 30% znižanje vrednosti iPTH; tak učinek je bil dosleden prek spektra različnih izhodiščnih koncentracij iPTH.
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 and/ or the presence of residual kidney function.
Vzrok bi lahko bile nižje izhodiščne koncentracije kalcija v serumu in/ ali preostalo delovanje ledvic.
28 Cinacalcet is metabolised by multiple enzymes, predominantly CYP3A4 and CYP1A2 (the contribution of CYP1A2 has not been characterised clinically).
Presnova cinakalceta poteka z več encimi, pretežno s CYP3A4 in CYP1A2 (prispevek CYP1A2 klinično ni opredeljen).
Based on in vitro data, cinacalcet is a strong inhibitor of CYP2D6, but is neither an inhibitor of other CYP enzymes at concentrations achieved clinically, including CYP1A2, CYP2C8, CYP2C9, CYP2C19, and CYP3A4 nor an inducer of CYP1A2, CYP2C19 and CYP3A4.
28 Na podlagi podatkov in vitro cinakalcet močno zavira CYP2D6, a v klinično doseženih koncentracijah ne zavira drugih encimov CYP, vključno s CYP1A2, CYP2C8, CYP2C9, CYP2C19 in CYP3A4 in ne inducira CYP1A2, CYP2C19 in CYP3A4.
Cataracts and lens opacities were observed in the repeat dose rodent toxicology and carcinogenicity studies, but were
V študijah toksičnosti pri ponavljajočih se odmerkih in študijah kancerogenega potenciala pri glodalcih so ugotavljali katarakte in motnjave leč; takšnih sprememb niso ugotovili pri psih in opicah in tudi ne v kliničnih študijah, v katerih so spremljali nastajanje katarakt.
29 not observed in dogs or monkeys or in clinical studies where cataract formation was monitored.
29 eksperimentalnimi pogoji.
32 A MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJE
The MAH must ensure that the system of pharmacovigilance, as described in version 3 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.
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da je sistem farmakovigilance, kot je opisan v različici 3, predstavljen v modulu 1. 8. 1 vloge za pridobitev dovoljenja za promet z zdravilom, vzpostavljen in deluje, preden da zdravilo v promet in toliko časa, kolikor bo zdravilo na trgu.
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version of 9 November 2007 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Imetnik dovoljenja za promet se zavezuje, da bo izvedel študije in dodatne farmakovigilančne dejavnosti., podrobno opisane v načrtu farmakovigilance, sprejetem 9. novembra 2007 za obvladovanje tveganja (RMP – "Risk Management Plan"), predstavljenem v modulu 1. 8. 2 vloge za pridobitev dovoljenja za promet z zdravilom in vseh nadaljnjih posodobitvah RMP, s katerimi soglaša Odbor za zdravila za uporabo v humani medicini (CHMP).
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
Po smernicah CHMP o sistemih za obvladovanje tveganja za zdravila za humano uporabo mora imetnik dovoljenja za promet predložiti posodobljen načrt RMP hkrati z naslednjim periodičnim poročilom o varnosti zdravila (PSUR).
- When new information is received that may impact on the current Safety Specification,
- kadar imetnik dovoljenja za promet z zdravilom prejme nove informacije, ki bi lahko vplivale na
Pharmacovigilance Plan or risk minimisation activities
trenutne varnostne specifikacije zdravila, načrt farmakovigilance ali na dejavnost za zmanjševanje tveganja.
- Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being
- v 60 dneh po tem, ko je bil dosežen pomemben mejnik (pri farmakovigilanci ali dejavnostih za
reached
zmanjševanje tveganja),
35 PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR BLISTER
35 PODATKI NA ZUNANJI OVOJNINI
Each tablet contains 30 mg of cinacalcet (as hydrochloride)
Ena tableta vsebuje 30 mg cinakalceta (v obliki klorida).
14 tablets 28 tablets 84 tablets
14 tablet 28 tablet 84 tablet
38 PARTICULARS TO APPEAR ON THE OUTER PACKAGING BOTTLE
38 PODATKI NA ZUNANJI OVOJNINI
40 PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR BOTTLE
40 PODATKI NA ZUNANJI OVOJNINI
BATCH NUMBER
ŠTEVILKA
42 PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR BLISTER
42 PODATKI NA ZUNANJI OVOJNINI
Each tablet contains 60 mg of cinacalcet (as hydrochloride)
Ena tableta vsebuje 60 mg cinakalceta (v obliki klorida).
45 PARTICULARS TO APPEAR ON THE OUTER PACKAGING BOTTLE
45 PODATKI NA ZUNANJI OVOJNINI
47 PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR BOTTLE
47 PODATKI NA ZUNANJI OVOJNINI
49 PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR BLISTER
49 PODATKI NA ZUNANJI OVOJNINI
Each tablet contains 90 mg of cinacalcet (as hydrochloride)
Ena tableta vsebuje 90 mg cinakalceta (v obliki klorida).
51 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
51 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
52 PARTICULARS TO APPEAR ON THE OUTER PACKAGING BOTTLE
52 PODATKI NA ZUNANJI OVOJNINI
54 PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR BOTTLE
54 PODATKI NA ZUNANJI OVOJNINI