natgillin/translations-raw huggingface dataset:
For more information about treatment with Cinacalcet Mylan, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Cinakalcet Mylan preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Cinacalcet Mylan, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
This means that Cinacalcet Mylan is similar to a ‘reference medicine' already authorised in the European Union (EU).
To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Mimpara.
For practical information about using Cinacalcet Mylan, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Cinakalcet Mylan naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
Once a maintenance dose has been established, calcium levels should be measured monthly and PTH levels should be measured every one to three months.
Ko je vzdrževalni odmerek določen, je treba ravni kalcija meriti enkrat na mesec, ravni paratiroidnega hormona pa redno na en do tri mesece.
Cinacalcet Mylan contains the active substance cinacalcet and is a ‘generic medicine'.
Zdravilo Cinakalcet Mylan vsebuje zdravilno učinkovino cinakalcet in je „generično zdravilo“.
Because Cinacalcet Mylan is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Mimpara.
Ker je zdravilo Cinakalcet Mylan generično zdravilo, so bile študije pri ljudeh omejene na preskuse za ugotavljanje, ali je biološko enakovredno referenčnemu zdravilu Mimpara.
Blood calcium levels should be measured frequently, and within one week of each dose adjustment of Cinacalcet Mylan.
Ravni kalcija v krvi je treba meriti pogosto in v prvem tednu po vsaki prilagoditvi odmerka zdravila Cinakalcet Mylan.
Cinacalcet Mylan cinacalcet
Cinakalcet Mylan cinakalcet
Cinacalcet Mylan is a medicine used in adults and older patients to:
Zdravilo Cinakalcet Mylan se uporablja pri odraslih in starostnikih:
Therefore, the CHMP's view was that, as for Mimpara, the benefit outweighs the identified risk.
Zato je menil, da njegove koristi enako kot pri zdravilu Mimpara odtehtajo znana tveganja.
Other information about Cinacalcet Mylan
Druge informacije o zdravilu Cinakalcet Mylan
The active substance in Cinacalcet Mylan, cinacalcet, works by increasing the sensitivity of the calciumsensing receptors on the parathyroid glands that regulate PTH secretion.
Zdravilna učinkovina v zdravilu Cinakalcet Mylan, cinakalcet, deluje tako, da poveča občutljivost receptorjev za zaznavanje kalcija, ki se nahajajo na obščitnicah in uravnavajo izločanje paratiroidnega hormona.
What is Cinacalcet Mylan and what is it used for?
Kaj je zdravilo Cinakalcet Mylan in za kaj se uporablja?
PTH levels should be assessed at least 12 hours after dosing and one to four weeks after each dose adjustment of Cinacalcet Mylan.
Ravni paratiroidnega hormona je treba izmeriti najmanj 12 ur po zaužitju odmerka zdravila Cinakalcet Mylan in en do štiri tedne po vsaki prilagoditvi odmerka.
It is not intended to provide practical advice on how to use Cinacalcet Mylan.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
Why is Cinacalcet Mylan approved?
Zakaj je bilo zdravilo Cinakalcet Mylan odobreno?
The dose of Cinacalcet Mylan 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.
Pri bolnikih s paratiroidnim karcinomom ali primarnim hiperparatiroidizmom je priporočeni začetni odmerek zdravila Cinakalcet Mylan za odrasle 30 mg dvakrat na dan. Odmerek zdravila Cinakalcet Mylan je treba povečevati vsakih dva do štiri tedne do vrednosti 90 mg tri- ali štirikrat dnevno, če je potrebno za znižanje ravni kalcija v krvi na normalno raven.
The dose is adjusted every two to four weeks, according to the patient's PTH levels, up to a maximum of 180 mg once a day.
Pri sekundarnem hiperparatiroidizmu je priporočeni začetni odmerek za odrasle 30 mg enkrat na dan. Odmerek se prilagodi vsakih dva do štiri tedne v skladu z bolnikovimi ravnmi paratiroidnega hormona in lahko znaša največ 180 mg enkrat na dan.
How has Cinacalcet Mylan been studied?
Kako je bilo zdravilo Cinakalcet Mylan raziskano?
How is Cinacalcet Mylan used?
Kako se zdravilo Cinakalcet Mylan uporablja?
How does Cinacalcet Mylan work?
Kako zdravilo Cinakalcet Mylan deluje?
Strength
Stična ovojnina
The following deficiencies were identified:
Odkrili sta naslednje pomanjkljivosti:
In addition, any significant safety events may only develop after a long period of time.
Poleg tega se utegnejo morebitni pomembni varnostni dogodki pojaviti šele po daljšem času.
SoliCol D3
Zdravilo SoliCol D3
The consistent and continuous lack of adequate quality assurance since before 2015 is therefore of serious concern.
Stalno in nenehno pomanjkanje ustreznega zagotavljanja kakovosti iz obdobja pred letom 2015 je zato zelo zaskrbljujoče.
The DHPCs should be sent in accordance with the agreed communication plan.
Neposredna obvestila je treba poslati v skladu z dogovorjenim načrtom sporočanja.
In addition to the measures already implemented following the initial MHRA inspection in June 2015, further quality actions are currently on-going to improve the quality systems in place at the manufacturing site.
Poleg že izvedenih ukrepov po začetnem inšpekcijskem pregledu agencije MHRA junija 2015 se trenutno izvajajo dodatni ukrepi v zvezi z izboljšanjem sistemov kakovosti v proizvodnem obratu.
The reliability of the safety database to detect such an effect is very low.
Zanesljivost zbirke podatkov o varnosti zdravila je za odkrivanje takega učinka zelo majhna.
The CHMP was requested to issue an opinion as to whether marketing authorisations of the medicinal products that include the above mentioned site should be maintained, varied, suspended, or revoked.
Odbor CHMP je bil zaprošen, naj poda mnenje o tem, ali naj se dovoljenja za promet z zdravili, ki zadevajo zgoraj omenjen obrat, ohranijo, spremenijo, začasno umaknejo ali ukinejo.
Nevertheless, the quality system at the manufacturing site is still significantly lacking in terms of change control and quality oversight.
Kljub temu pa je sistem kakovosti v proizvodnem obratu z vidika nadzora nad spremembami in nadzora nad kakovostjo še vedno zelo pomanjkljiv.
This is a severe condition and a significant number of patients are treated with Ammonaps in the EU.
To je resno stanje in v EU se z zdravilom Ammonaps zdravi precejšnje število bolnikov.
SoliCol D3 was approved in the UK through a national procedure on 18 December 2015.
Zdravilo SoliCol D3 je dovoljenje za promet v Združenem kraljestvu pridobilo 18. decembra 2015 po nacionalnem postopku.
Further testing of the product on importation in the EU was also put in place with a new set of analytical results being generated prior to the release.
Ob uvozu v EU je bilo vzpostavljeno dodatno preskušanje zdravila, pri čemer se pred sproščanjem pripravi nov sklop analitskih rezultatov.
Grounds for CHMP opinion Whereas
Podlaga za mnenje odbora CHMP
• Major deficiencies relating to organisational data governance failures, sterilisation and depyrogenation processes, and insufficient control of aseptic operations to provide the required level of sterility assurance.
• večje pomanjkljivosti v zvezi z neuspešnim organizacijskim upravljanjem podatkov, procesoma sterilizacije in depirogenizacije ter nezadostnim nadzorom nad aseptičnimi operacijami za zagotavljanje ustrezne ravni zagotavljanja sterilnosti.
• Critical deficiencies relating to the failure of organisational and technical measures to minimise the risk of cross-contamination between hazardous and non-hazardous products manufactured in the same manufacturing facilities using shared equipment, as well as failures of the quality unit to ensure the effective operation of the quality system;
• kritične pomanjkljivosti v zvezi z neuspešnimi organizacijskimi in tehničnimi dejavnostmi za zmanjševanje tveganja za navzkrižno kontaminacijo med nevarnimi in nenevarnimi izdelki, ki se proizvajajo v istih proizvodnih obratih z isto opremo, ter nezmožnost enote za kakovost zagotoviti učinkovito delovanje sistema kakovosti;
A detailed assessment of all product complaint reports over the past 5 years provided by the MAH did not reveal any product complaint that could be associated to potential cross contamination.
Podrobna ocena vseh poročil o pritožbah glede zdravila v zadnjih petih letih, ki jih je predložil imetnik dovoljenja za promet z zdravilom, ni odkrila nobene pritožbe glede zdravila, ki bi bila povezana z morebitno navzkrižno kontaminacijo.
These measures include the use of assistance from experienced external specialists specialised in Quality management and an enhanced control of the batch documents by the Qualified Person at the EEA site responsible for batch release.
Ti ukrepi vključujejo uporabo pomoči izkušenih zunanjih strokovnjakov za upravljanje kakovosti in okrepljen nadzor nad dokumenti o serijah s strani usposobljene osebe v obratu v EGP, odgovorne za sproščanje serij.
The sourcing of Lutinus from PII has stopped in 2014 and the manufacturing of the product fully switched to an alternative site registered in December 2013.
Nabava zdravila Lutinus od družbe PII se je leta 2014 ustavila, proizvodnja zdravila pa se je v celoti premaknila v drug obrat, registriran decembra 2013.
• The CHMP reviewed the inspection report provided by the Supervisory Authority, the (co-) rapporteur's assessment reports and the available data presented by the MAHs in writing in response to questions addressed by the CHMP;
• odbor CHMP je pregledal poročilo inšpekcijskega pregleda, ki ga je predložil nadzorni organ, poročila o oceni (so)poročevalca in razpoložljive podatke, ki so jih pisno predložili imetniki dovoljenj za promet z zdravili v odgovor na vprašanja, ki jih je zastavil odbor;
This product was approved in the EU via a decentralised procedure including all 28 Member States, with Sweden acting as reference Member State.
To zdravilo je dovoljenje za promet v EU pridobilo po decentraliziranem postopku, ki je vključeval vseh 28 držav članic, pri čemer je bila v vlogi referenčne države članice Švedska.
It is indicated in all patients with neonatal-onset presentation (complete enzyme deficiencies, presenting within the first 28 days of life).
Indicirano je pri vseh bolnikih, pri katerih se bolezen pojavi v neonatalni fazi (popolno pomanjkanje encima, ki se pojavi v prvih 28 dneh življenja).
Lutinus is a vaginal tablet containing 100 mg progesterone, indicated for luteal support as part of treatment program for infertile women.
Zdravilo Lutinus je na voljo v obliki vaginalne tablete, ki vsebuje 100 mg progesterona, in je indicirano za lutealno podporo kot del programa zdravljenja neplodnosti pri ženskah.
Ammonaps is available as white oval tablets (500 mg) and as granules (940 mg/g).
Zdravilo Ammonaps je na voljo v obliki belih ovalnih tablet (500 mg) in v obliki zrnc (940 mg/g).
SoliCol D3 20,000 IU tablets and SoliCol D3 50,000 IU tablets are medicinal products containing 20,000 or 50000 IU colecalciferol (vitamin D3 analogue) as active substance.
Zdravili SoliCol D3 20 000 i.e. tablete in SoliCol D3 50 000 i.e. tablete kot zdravilno učinkovino vsebujeta 20 000 oziroma 50 000 i.e. holekalciferola (analoga vitamina D3).
A detailed assessment of cumulative safety data on Lutinus up to 31 May 2016 was also performed which did not raise any significant safety concerns related to GMP non-compliance.
Opravljena je bila tudi podrobna ocena kumulativnih podatkov o varnosti zdravila Lutinus do 31. maja 2016, pri kateri niso odkrili nobenih pomembnih pomislekov o varnosti, povezanih z neskladnostjo z dobro proizvodno prakso.
Further, patients need life-long treatment and other available treatment options appear limited, because of concerns over the supply of alternatives and the fact that some of these cannot be administered via naso-gastric/gastrostomy tubes, which is often needed in these patients.
Poleg tega bolniki potrebujejo zdravljenje, ki traja vse življenje, druge možnosti zdravljenja pa so omejene, in sicer zaradi pomislekov pri dobavi drugih možnosti in dejstva, da nekaterih med njimi ni mogoče dajati z nazogastrično sondo oziroma gastrostomo, ki ju ti bolniki pogosto potrebujejo.
Furthermore, the CHMP recommended that in due course, appropriate communications should be issued and proposed Direct Healthcare Professional Communications (DHPC) to inform on the outcome of the review and the conclusions reached concerning the use of Ammonaps.
Nadalje je odbor CHMP priporočil, da se pravočasno izdajo ustrezna obvestila, in predlagal, da se z neposrednimi obvestili za zdravstvene delavce ti obvestijo o izidu pregleda in zaključkih o uporabi zdravila Ammonaps.
It is also indicated in patients with late-onset disease (partial enzyme deficiencies, presenting after the first month of life) who have a history of hyperammonaemic encephalopathy.
Indicirano je tudi pri bolnikih z zapoznelim pojavom bolezni (delno pomanjkanje encima, ki se pojavi po prvem mesecu življenja), ki imajo anamnezo hiperamonemične encefalopatije.
In addition, Ammonaps should not be used if an alternative treatment option is available and appropriate for the patient.
Zdravilo Ammonaps se ne sme uporabljati, če obstaja druga možnost zdravljenja, primerna za bolnika.
Given that all EU Member States are currently supplied with Lutinus manufactured at the alternative manufacturing site, no shortage is foreseen for this product.
Ker trenutno vse države članice EU nabavljajo zdravilo Lutinus, proizvedeno v drugem proizvodnem obratu, pomanjkanje tega zdravila ni predvideno.
Although no reports of cross-contamination have been reported in the post-marketing setting, taking into account the target population, that is severely ill and the small patient population (as the prevalence of the condition is very low), the lack of such reports only provides a low degree of reassurance.
Čeprav iz obdobja trženja ni poročil o navzkrižni kontaminaciji, ob upoštevanju ciljne populacije, ki je kritično bolna, in majhne populacije bolnikov (saj je prevalenca bolezni zelo majhna) pomanjkanje tovrstnih poročil ni zadostno zagotovilo.
Pharmaceutics International Inc. (PII), located in Maryland, USA is listed as manufacturer in the marketing authorisation of four products authorised in the EU, including the centrally approved product Ammonaps and three nationally approved products: Lutinus, Dutasteride Actavis and SoliCol D3.
Družba Pharmaceutics International Inc. (PII) iz Marylanda v ZDA je v dovoljenjih za promet z zdravili navedena kot izdelovalec štirih zdravil z dovoljenjem za promet v EU, vključno z zdravilom Ammonaps, ki je dovoljenje pridobilo po centraliziranem postopku, in tremi zdravili, ki so dovoljenje pridobila po nacionalnem postopku: Lutinus, Dutasteride Actavis in SoliCol D3.
In February 2016, a joint inspection by the Medicines and Healthcare Products Regulatory Agency (MHRA) and the US Food and Drug Administration (FDA) found critical and major deficiencies and concluded that PII was non-compliant with the legal requirements and/or the principles and guidelines of Good Manufacturing Practice (GMP) as provided for by Union law.
Februarja 2016 sta regulativna agencija Združenega kraljestva za zdravila in zdravstvene izdelke (MHRA) in agencija ZDA za zdravila in prehrano (FDA) v skupnem inšpekcijskem pregledu odkrili kritične in večje pomanjkljivosti ter zaključili, da družba PII ne deluje v skladu z zakonskimi zahtevami in/ali načeli in smernicami dobre proizvodne prakse, kot zahteva zakonodaja Unije.
The additional risks due to non-compliance to GMP can potentially lead to potential cross-contamination with other drugs produced at the site, including hormones, cytotoxics and teratogens.
Dodatna tveganja zaradi neskladnosti z dobro proizvodno prakso lahko morebiti privedejo do možne navzkrižne kontaminacije z drugimi zdravili, ki se izdelujejo v tem obratu, vključno s hormoni, citotoksičnimi zdravili in teratogenimi učinkovinami.
Dutasteride Actavis is indicated for the treatment of the benign prostatic hyperplasia and was first approved in the EU on 3 June 2015 via a decentralised procedure, with Denmark acting as Reference Member State.
Zdravilo Dutasteride Actavis je indicirano za zdravljenje benigne hiperplazije prostate in je dovoljenje za promet v EU pridobilo 3. junija 2015 po decentraliziranem postopku, pri čemer je bila v vlogi referenčne države članice Danska.
On 17 June 2016, the European Commission (EC) initiated a referral procedure under Article 31 of Directive 2001/83/EC, and requested the Agency to assess the potential impact of the deficiencies on the quality, safety and the benefit risk balance of the medicinal products which have been authorised by the European Commission and the Member States.
Evropska komisija je 17. junija 2016 sprožila napotitveni postopek v skladu s členom 31 Direktive 2001/83/ES in zahtevala od agencije, da oceni morebiten vpliv pomanjkljivosti na kakovost, varnost in razmerje med tveganji in koristmi zdravil, ki so pridobila dovoljenje za promet od Evropske komisije in v državah članicah.
The safety profile of Ammonaps in urea cycle disorders is well established.
Varnostni profil zdravila Ammonaps pri motnjah v ciklusu sečnine je dobro uveljavljen.
A medicinal product may be considered critical based on the evaluation of the potential unmet medical need, considering the availability of suitable alternative medicinal products in the respective Member State(s) and, as appropriate, the nature of the disease to be treated.
Zdravilo se lahko šteje za zdravilo kritičnega pomena na podlagi ocene morebitnih neizpolnjenih zdravstvenih potreb ter ob upoštevanju razpoložljivosti ustreznih alternativnih zdravil v eni ali več zadevnih državah članicah in, če je primerno, narave zdravljene bolezni.
It is acknowledged that the shift of manufacturing of Ammonaps to a dedicated area using dedicated equipment provides some reassurance and the risk of cross-contamination following this change is considered low.
Res je, da je selitev proizvodnje zdravila Ammonaps v ločeno območje z ločeno opremo do neke mere zadovoljiva in da je tveganje za navzkrižno kontaminacijo po tej selitvi nizko.
This certificate of GMP compliance is valid until 30 June 2017.
Ta certifikat o skladnosti z dobro proizvodno prakso je veljaven do 30. junija 2017.
All medicinal products Dutasteride Actavis currently available on the EU market were manufactured at an alternative manufacturing site already registered in the marketing authorisation at time of approval.
Vsa zdravila Dutasteride Actavis, ki so trenutno na voljo na trgu EU, so bila proizvedena v drugem proizvodnem obratu, ki je bilo v času pridobitve dovoljenja za promet že registrirano v dovoljenju za promet z zdravilom.
• The CHMP considered the procedure under Article 31 of Directive 2001/83/EC for medicinal products for which Pharmaceutics International Inc, Maryland, USA, is included in the marketing authorisation as manufacturing site;
• odbor CHMP je obravnaval postopek v skladu s členom 31 Direktive 2001/83/ES za zdravila, za katera je družba Pharmaceutics International Inc. iz Marylanda v ZDA vključena v dovoljenje za promet z zdravilom kot proizvodni obrat;
Given the absence of reports of cross-contamination and taking into consideration the criticality of the product and the improvements in manufacturing which has reduced the risk of cross-contamination to low, it is recommended that the supply of Ammonaps from PII is maintained for the patient population for whom no other treatment option is available.
Glede na odsotnost poročil o navzkrižni kontaminaciji in z upoštevanjem kritičnega pomena zdravila ter izboljšav v proizvodnji, s čimer je tveganje za navzkrižno kontaminacijo postalo majhno, se priporoča, da se dobava zdravila Ammonaps iz družbe PII ohrani za populacijo bolnikov, pri katerih ni na voljo druge možnosti zdravljenja.
Lutinus (and associated names)
Zdravilo Lutinus (in povezana imena)
Also, unless no alternative options are available for patients, the use of Ammonaps granules should be limited to patients requiring administration through a nasogastric tube or gastrostomy.
Razen če za bolnike ni druge možnosti, je treba uporabo zdravila Ammonaps v obliki zrnc omejiti na bolnike, ki potrebujejo dajanje skozi nazogastrično sondo ali gastrostomo.
Based on the nature of the disease and the fact that therapeutic alternatives are not available in all Member States, the CHMP considers the product Ammonaps to be critical.
Zaradi narave bolezni in dejstva, da alternativna zdravila niso na voljo v vseh državah članicah EU, CHMP meni, da je zdravilo Ammonaps kritičnega pomena.
No alternative manufacturer is registered in the marketing authorisation of SoliCol D3.
V dovoljenju za promet z zdravilom SoliCol D3 ni registriran noben drug izdelovalec.
It is indicated to treat the patients who have urea cycle disorders (UCDs), involving deficiencies of carbamylphosphate synthetase, ornithine transcarbamylase or argininosuccinate synthetase.
Indicirano je za zdravljenje bolnikov z motnjami v ciklusu sečnine, kar vključuje pomanjkanje karbamil-fosfat-sintetaze, ornitin-transkarbamilaze ali argininosukcinat-sintetaze.
The current certificate of GMP compliance of PII will no longer be valid after 30 June 2017.
Trenutni certifikat o skladnosti z dobro proizvodno prakso za družbo PII po 30. juniju 2017 ne bo več veljaven.
• The CHMP noted that batches of Lutinus from Pharmaceutics international Inc. are currently available on the EU market.
• odbor CHMP ugotavlja, da so serije zdravila Lutinus iz družbe Pharmaceutics International Inc. trenutno na voljo na trgu EU;
According to this statement of non-compliance, the NCA should evaluate the criticality of products being supplied by PII and enact measures to ensure continued supply where appropriate.
V skladu s to izjavo o neskladnosti mora zadevni nacionalni pristojni organ oceniti kritičnost zdravil, ki jih dobavlja družba PII, in uvesti ukrepe za zagotovitev neprekinjene dobave, kjer je to potrebno.
• There is no alternative manufacturing site registered in the marketing authorisation for SoliCol D3 and the CHMP noted that no batches of SoliCol D3 are currently available on the EU market;
• V dovoljenju za promet z zdravilom SoliCol D3 ni registriran noben drug proizvodni obrat in odbor CHMP ugotavlja, da trenutno na trgu EU ni serij zdravila SoliCol D3;
The product has not yet been launched on the market and the MAH confirmed that no commercial batches of the product had been manufactured at PII.
Zdravilo še ni bilo dano na trg in imetnik dovoljenja za promet z zdravilom je potrdil, da v družbi PII ni bila proizvedena nobena komercialna serija zdravila.
The MAH should provide progress reports to inform on the progression of the actions taken to restore GMP compliance of the site after each identified milestone in accordance with the agreed timelines.
Imetnik dovoljenja za promet z zdravilom mora priskrbeti poročila o napredku in z njimi poročati o napredovanju ukrepov za ponovno vzpostavitev skladnosti z dobro proizvodno prakso v proizvodnem obratu po vsakem opredeljenem mejniku v skladu z dogovorjeno časovnico.