FrancophonIA/ELRC3.0 huggingface dataset:
English: Your doctor should do blood tests to check your liver function before and during treatment with Inlyta.
Slovenian: Zdravnik mora pred začetkom zdravljenja z zdravilom Inlyta in med njim opraviti preiskave krvi, da preveri delovanje vaših jeter.
English: Inlyta 1 mg film-coated tablets
Slovenian: Inlyta 1 mg filmsko obložena tableta
English: A dose decrease is recommended when administering axitinib to patients with moderate hepatic impairment (Child-Pugh class B) (see section 4.2).
Slovenian: Kadar se aksitinib daje bolnikom z zmerno okvaro jeter (razred B po Child-Pughu), je odmerek priporočljivo zmanjšati (glejte poglavje 4.2).
English: Median OS d in months (95% CI)
Slovenian: (95 % IZ) Mediana OS
English: Inlyta 7 mg film-coated tablets
Slovenian: Inlyta 7 mg filmsko obložena tableta
English: Inlyta 7 mg is available in bottles of 60 tablets and blisters of 14 tablets.
Slovenian: Zdravilo Inlyta 7 mg je na voljo v plastenkah s 60 tabletami in pretisnih omotih s 14 tabletami.
English: Reproduction toxicity
Slovenian: Škodljiv vpliv na sposobnost razmnoževanja
English: Inlyta 5 mg is available in bottles of 60 tablets and blisters of 14 tablets.
Slovenian: Zdravilo Inlyta 5 mg je na voljo v plastenkah s 60 tabletami in pretisnih omotih s 14 tabletami.
English: shortness of breath (signs of heart failure events)
Slovenian: (znaki srčnega popuščanja)
English: In pooled clinical studies with axitinib (N = 672) for the treatment of patients with RCC, gastrointestinal perforation and fistula were reported in 1.9% of patients receiving axitinib.
Slovenian: V združenih kliničnih preskušanjih z aksitinibom (n = 672) pri zdravljenju bolnikov z RCC so o perforaciji prebavil in fistuli poročali pri 1,9 % bolnikov, ki so prejemali aksitinib.
English: Each film-coated tablet contains 35.3 mg of lactose monohydrate.
Slovenian: Inlyta 3 mg filmsko obložena tableta Ena filmsko obložena tableta vsebuje 35,3 mg laktoze monohidrata.
English: Grade 3/4 venous embolic and thrombotic adverse reactions were reported in 3.1% of patients receiving axitinib.
Slovenian: O venskih emboličnih in trombotičnih neželenih učinkih 3. oziroma 4. stopnje so poročali pri 3,1 % bolnikov, ki so prejemali aksitinib.
English: • Weight loss
Slovenian: • zmanjšanje telesne mase
English: Thyroid dysfunction (see section 4.4)
Slovenian: Motnje delovanja ščitnice (glejte poglavje 4.4)
English: Tinnitus
Slovenian: Aksitinib
English: Concomitant strong CYP3A4/5 inducers
Slovenian: Sočasno zdravljenje z močnimi induktorji CYP3A4/5
English: Inlyta 7 mg film-coated tablets EU/1/12/777/010
Slovenian: Inlyta 7 mg filmsko obložene tablete EU/1/12/777/010
English: Liver function tests should be monitored before initiation of, and periodically throughout, treatment with axitinib.
Slovenian: Delovanje ščitnice je treba spremljati pred začetkom zdravljenja z aksitinibom in v rednih časovnih presledkih med zdravljenjem.
English: Axitinib has not been studied in subjects with renal impairment.
Slovenian: Uporabe aksitiniba pri osebah z okvaro ledvic niso preučevali.
English: Inlyta 5 mg film-coated tablets EU/1/12/777/004
Slovenian: Inlyta 5 mg filmsko obložene tablete EU/1/12/777/004
English: CYP3A4/5 inhibitors
Slovenian: Zaviralci CYP3A4/5
English: Inlyta 5 mg film-coated tablets are red, triangular and debossed with “Pfizer” on one side and “5 XNB” on the other.
Slovenian: Inlyta 5 mg filmsko obložene tablete so rdeče, trikotne, z vtisnjeno oznako “Pfizer” na eni strani in “5 XNB” na drugi strani.
English: In pooled clinical studies with axitinib (N = 672) for the treatment of patients with RCC, arterial embolic and thrombotic events were reported in 2.8% of patients receiving axitinib.
Slovenian: V združenih kliničnih preskušanjih z aksitinibom (n = 672) pri zdravljenju bolnikov z RCC so o arterijskih emboličnih in trombotičnih dogodkih poročali pri 2,8 % bolnikov, ki so prejemali aksitinib.
English: Inlyta 5 mg film-coated tablets
Slovenian: Inlyta 5 mg filmsko obložena tableta
English: In pooled clinical studies with axitinib (N = 672) for the treatment of patients with RCC, haemorrhagic events were reported in 25.7% of patients receiving axitinib.
Slovenian: V združenih kliničnih preskušanjih z aksitinibom (n = 672) pri zdravljenju bolnikov z RCC so o hemoragičnih dogodkih poročali pri 25,7 % bolnikov, ki so prejemali aksitinib.
English: Inlyta 3 mg is available in bottles of 60 tablets and blisters of 14 tablets.
Slovenian: Zdravilo Inlyta 3 mg je na voljo v plastenkah s 60 tabletami in pretisnih omotih s 14 tabletami.
English: Myalgia
Slovenian: Sorafenib
English: EU/1/12/777/008 56 tablets
Slovenian: EU/1/12/777/007 28 tablet EU/1/12/777/008 56 tablet
English: Concomitant strong CYP3A4/5 inhibitors
Slovenian: Sočasno zdravljenje z močnimi zaviralci CYP3A4/5
English: Monitoring for proteinuria before initiation of, and periodically throughout, treatment with axitinib is recommended.
Slovenian: Pred začetkom zdravljenja z aksitinibom in v rednih časovnih presledkih med zdravljenjem je priporočljivo spremljanje glede pojava proteinurije.
English: Inlyta 3 mg film-coated tablets
Slovenian: Inlyta 3 mg filmsko obložena tableta
English: Inlyta 1 mg film-coated tablets EU/1/12/777/001
Slovenian: Inlyta 1 mg filmsko obložene tablete EU/1/12/777/001
English: Inlyta 1 mg film-coated tablets are red, oval and debossed with “Pfizer” on one side and “1 XNB” on the other.
Slovenian: Inlyta 1 mg filmsko obložene tablete so rdeče, ovalne, z vtisnjeno oznako “Pfizer” na eni strani in “1 XNB” na drugi strani.
English: Very common Arthralgia Pain in extremity
Slovenian: Bolezni mišičnoskeletnega sistema in vezivnega tkiva zelo pogosti artralgija bolečine v okončinah pogosti mialgija
English: Inlyta 3 mg film-coated tablets EU/1/12/777/007
Slovenian: Inlyta 3 mg filmsko obložene tablete EU/1/12/777/007
English: In pooled clinical studies with axitinib (N = 672) for the treatment of patients with RCC, venous embolic and thrombotic events were reported in 2.8% of patients receiving axitinib.
Slovenian: V združenih kliničnih preskušanjih z aksitinibom (n = 672) pri zdravljenju bolnikov z RCC so o venskih emboličnih in trombotičnih dogodkih poročali pri 2,8 % bolnikov, ki so prejemali aksitinib.
English: Inlyta 3 mg film-coated tablets are red, round and debossed with “Pfizer” on one side and “3 XNB” on the other.
Slovenian: Inlyta 3 mg filmsko obložene tablete so rdeče, okrogle, z vtisnjeno oznako “Pfizer” na eni strani in “3 XNB” na drugi strani.
English: Inlyta 7 mg film-coated tablets are red, diamond shaped and debossed with “Pfizer” on one side and “7 XNB” on the other.
Slovenian: Inlyta 7 mg filmsko obložene tablete so rdeče, rombaste, z vtisnjeno oznako “Pfizer” na eni strani in “7 XNB” na drugi strani.
English: In pooled clinical studies with axitinib (N = 672) for the treatment of patients with RCC, polycythaemia was reported in 1.5% of patients receiving axitinib.
Slovenian: V združenih kliničnih preskušanjih z aksitinibom (n = 672) pri zdravljenju bolnikov z RCC so o policitemiji poročali pri 1,5 % bolnikov, ki so prejemali aksitinib.
English: Selection of concomitant medicinal products with no or minimal CYP3A4/5 induction potential is recommended.
Slovenian: Priporočljiva je izbira sočasno uporabljanih zdravil, ki ne inducirajo ali minimalno inducirajo CYP3A4/5.
English: All Gradesb
Slovenian: Vse stopnje
English: Signs or symptoms of cardiac failure should periodically be monitored throughout treatment with axitinib.
Slovenian: Med zdravljenjem z aksitinibom je treba redno spremljati znake ali simptome srčnega popuščanja.
English: • Redness and swelling of the palms of the hands or soles of the feet (hand-foot syndrome),
Slovenian: • rdečina in otekanje dlani ali podplatov (sindrom dlani-podplatov), kožni izpuščaj, suha koža
English: EU/1/12/777/002 56 tablets
Slovenian: EU/1/12/777/001 28 tablet EU/1/12/777/002 56 tablet
English: • Under-active thyroid gland (may show in your blood tests)
Slovenian: • premalo dejavna žleza ščitnica (to se lahko pokaže pri preiskavah krvi)
English: • Hyper-active thyroid gland (may show in your blood tests)
Slovenian: • preveč dejavna žleza ščitnica (to se lahko pokaže pri preiskavah krvi)
English: It may harm them, even if their signs of illness are the same as yours.
Slovenian: 29,4 (24,5; NE) 27,8 (23,1; 34,5)
English: Median PFS a,b in months (95% CI)
Slovenian: a,b v mesecih
English: Selection of an alternate concomitant medicinal product with no or minimal CYP3A4/5 induction potential is recommended.
Slovenian: Priporočljivo je izbrati drugo sočasno uporabljano zdravilo, ki ne inducira ali minimalno inducira CYP3A4/5.
English: In a controlled clinical study with axitinib for the treatment of patients with RCC, gastrointestinal perforation-type events were reported in 1.7% of patients receiving axitinib, including anal fistula (0.6%), fistula (0.3%) and gastrointestinal perforation (0.3%).In monotherapy studies with axitinib (N = 850), gastrointestinal perforation-type events were reported in 1.9% of patients and fatal gastrointestinal perforation was reported in one patient (0.1%).
Slovenian: Perforacija prebavil in nastanek fistule (glejte poglavje 4.4) V nadzorovanem kliničnem preskušanju z aksitinibom pri zdravljenju bolnikov z RCC so o dogodkih tipa perforacije prebavil poročali pri 1,7 % bolnikov, ki so prejemali aksitinib; ti so vključevali analno fistulo (0,6 %), fistulo (0,3 %) in perforacijo prebavil (0,3%).
English: Very common Decreased appetite Common
Slovenian: Presnovne in prehranske motnje zelo pogosti zmanjšan apetit pogosti dehidracija hiperkaliemija hiperkalciemija
English: EU/1/12/777/005 56 tablets
Slovenian: EU/1/12/777/004 28 tablet EU/1/12/777/005 56 tablet
English: Your doctor should monitor for signs or symptoms of heart failure events periodically throughout treatment with axitinib.
Slovenian: Med zdravljenjem z aksitinibom bo zdravnik redno spremljal znake ali simptome srčnega popuščanja.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Inlyta 1 mg film-coated tablets Each film-coated tablet contains 1 mg of axitinib.
Slovenian: Inlyta 1 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 1 mg aksitiniba.
English: Symptoms of gastrointestinal perforation or fistula should be periodically monitored for throughout treatment with axitinib.
Slovenian: Med zdravljenjem z aksitinibom je potrebno redno spremljanje glede morebitnega pojava simptomov perforacije prebavil ali nastanka fistule.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 1 mg axitinib.
Slovenian: Ena filmsko obložena tableta vsebuje 1 mg aksitiniba.
English: Uncommon Posterior reversible encephalopathy syndromee
Slovenian: Bolezni živčevja zelo pogosti glavobol disgevzija pogosti omotica občasni sindrom posteriorne reverzibilne encefalopatije
English: Blood and lymphatic system disorders
Slovenian: Bolezni krvi in limfatičnega sistema pogosti anemija trombocitopenija policitemija občasni nevtropenija levkopenija
English: Haemorrhage In clinical studies with axitinib, haemorrhagic events were reported (see section 4.8).
Slovenian: Krvavitve V kliničnih preskušanjih z aksitinibom so poročali o pojavu krvavitev (glejte poglavje 4.8).
English: SN
Slovenian: ORR
English: NAME OF THE MEDICINAL PRODUCT Inlyta 7 mg film-coated tablets axitinib
Slovenian: Inlyta 7 mg filmsko obložene tablete aksitinib
English: In a controlled clinical study with axitinib for the treatment of patients with RCC, polycythaemia was reported in 1.4% of patients receiving axitinib.
Slovenian: Policitemija (glejte Zvišanje ravni hemoglobina ali hematokrita v poglavju 4.4) V nadzorovanem kliničnem preskušanju z aksitinibom pri zdravljenju bolnikov z RCC so o policitemiji poročali pri 1,4 % bolnikov, ki so prejemali aksitinib.
English: Uncommon Neutropaenia Leukopaenia
Slovenian: Neželeni učinki na jetra
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 7 mg axitinib.
Slovenian: Ena filmsko obložena tableta vsebuje 7 mg aksitiniba.
English: ‘Secondary' means that it is caused by another condition.
Slovenian: „Sekundarni“ pomeni, da nastane kot posledica drugega bolezenskega stanja.
English: The full EPAR and risk management plan summary for Cinacalcet Mylan can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) in povzetek načrta obvladovanja tveganj za zdravilo Cinakalcet Mylan sta na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Hyperparathyroidism is a condition in which the parathyroid glands in the neck produce too much parathyroid hormone (PTH), which can lead to high levels of calcium in the blood, bone and joint pain and deformities of the arms and legs.
Slovenian: Hiperparatiroidizem je stanje, pri katerem obščitnice v vratu tvorijo preveč paratiroidnega hormona (PTH), kar lahko povzroči visoke ravni kalcija v krvi, bolečine v kosteh in sklepih ter deformacije rok in nog.
English: This is a summary of the European public assessment report (EPAR) for Cinacalcet Mylan.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Cinakalcet Mylan.
English: What measures are being taken to ensure the safe and effective use of Cinacalcet Mylan?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Cinakalcet Mylan?
English: • treat secondary hyperparathyroidism in patients with serious kidney disease who need dialysis to clear their blood of waste products.
Slovenian: • za zdravljenje sekundarnega hiperparatiroidizma pri bolnikih z resnim obolenjem ledvic, ki za očiščenje odpadnih snovi iz krvi potrebujejo dializo.
English: Cinacalcet Mylan is available as 30, 60 and 90 mg tablets.
Slovenian: Zdravilo Cinakalcet Mylan je na voljo v obliki tablet (30, 60 in 90 mg).
English: Cinacalcet Mylan can be used as part of treatment including phosphate binders or vitamin D;
Slovenian: Zdravilo Cinakalcet Mylan se lahko uporablja kot del zdravljenja, ki vključuje vezalce fosfatov ali vitamin D;
English: The reduction in PTH levels leads to a decrease in blood calcium levels.
Slovenian: Zmanjšanje ravni paratiroidnega hormona privede do znižanja ravni kalcija v krvi.
English: Cinacalcet Mylan is taken with food or shortly after a meal.
Slovenian: Zdravilo Cinakalcet Mylan se jemlje s hrano ali kmalu po obroku.
English: ‘Primary' means that the hyperparathyroidism is not caused by any other condition.
Slovenian: „Primarni“ pomeni, da ni posledica nobenega drugega bolezenskega stanja.
English: What are the benefits and risks of Cinacalcet Mylan?
Slovenian: Kakšne so koristi in tveganja, povezani z zdravilom Cinakalcet Mylan?
English: A risk management plan has been developed to ensure that Cinacalcet Mylan is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila Cinakalcet Mylan je bil pripravljen načrt obvladovanja tveganj.
English: • reduce hypercalcaemia (high blood calcium levels) in patients with parathyroid carcinoma (cancer of the parathyroid glands) or with primary hyperparathyroidism who cannot have their parathyroid glands removed or when the doctor thinks that their removal is not appropriate.
Slovenian: • za zmanjšanje hiperkalciemije (visokih ravni kalcija v krvi) pri bolnikih s paratiroidnim karcinomom (rakom obščitnic) ali s primarnim hiperparatiroidizmom, pri katerih obščitnic ni mogoče odstraniti oziroma zdravnik meni, da njihova odstranitev ni primerna.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Cinacalcet Mylan has been shown to have comparable quality and to be bioequivalent to Mimpara.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Cinakalcet Mylan primerljivo raven kakovosti kot zdravilo Mimpara ter da mu je biološko enakovredno.
English: The Committee recommended that Cinacalcet Mylan be approved for use in the EU.
Slovenian: Priporočil je, da se zdravilo Cinakalcet Mylan odobri za uporabo v EU.
English: Because Cinacalcet Mylan is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Slovenian: Ker je zdravilo Cinakalcet Mylan generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so koristi in tveganja enaki kot pri referenčnem zdravilu.
English: For more information about treatment with Cinacalcet Mylan, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: This means that Cinacalcet Mylan is similar to a ‘reference medicine' already authorised in the European Union (EU).
Slovenian: To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Mimpara.
English: For practical information about using Cinacalcet Mylan, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Cinakalcet Mylan naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: Once a maintenance dose has been established, calcium levels should be measured monthly and PTH levels should be measured every one to three months.
Slovenian: Ko je vzdrževalni odmerek določen, je treba ravni kalcija meriti enkrat na mesec, ravni paratiroidnega hormona pa redno na en do tri mesece.
English: Cinacalcet Mylan contains the active substance cinacalcet and is a ‘generic medicine'.
Slovenian: Zdravilo Cinakalcet Mylan vsebuje zdravilno učinkovino cinakalcet in je „generično zdravilo“.
English: 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.
Slovenian: Ker je zdravilo Cinakalcet Mylan generično zdravilo, so bile študije pri ljudeh omejene na preskuse za ugotavljanje, ali je biološko enakovredno referenčnemu zdravilu Mimpara.
English: Blood calcium levels should be measured frequently, and within one week of each dose adjustment of Cinacalcet Mylan.
Slovenian: Ravni kalcija v krvi je treba meriti pogosto in v prvem tednu po vsaki prilagoditvi odmerka zdravila Cinakalcet Mylan.
English: Cinacalcet Mylan cinacalcet
Slovenian: Cinakalcet Mylan cinakalcet
English: Cinacalcet Mylan is a medicine used in adults and older patients to:
Slovenian: Zdravilo Cinakalcet Mylan se uporablja pri odraslih in starostnikih:
English: Therefore, the CHMP's view was that, as for Mimpara, the benefit outweighs the identified risk.
Slovenian: Zato je menil, da njegove koristi enako kot pri zdravilu Mimpara odtehtajo znana tveganja.
English: Other information about Cinacalcet Mylan
Slovenian: Druge informacije o zdravilu Cinakalcet Mylan
English: The active substance in Cinacalcet Mylan, cinacalcet, works by increasing the sensitivity of the calciumsensing receptors on the parathyroid glands that regulate PTH secretion.
Slovenian: 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.
English: What is Cinacalcet Mylan and what is it used for?
Slovenian: Kaj je zdravilo Cinakalcet Mylan in za kaj se uporablja?
English: PTH levels should be assessed at least 12 hours after dosing and one to four weeks after each dose adjustment of Cinacalcet Mylan.
Slovenian: Ravni paratiroidnega hormona je treba izmeriti najmanj 12 ur po zaužitju odmerka zdravila Cinakalcet Mylan in en do štiri tedne po vsaki prilagoditvi odmerka.
English: It is not intended to provide practical advice on how to use Cinacalcet Mylan.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: Why is Cinacalcet Mylan approved?
Slovenian: Zakaj je bilo zdravilo Cinakalcet Mylan odobreno?
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: How has Cinacalcet Mylan been studied?
Slovenian: Kako je bilo zdravilo Cinakalcet Mylan raziskano?
English: How is Cinacalcet Mylan used?
Slovenian: Kako se zdravilo Cinakalcet Mylan uporablja?
English: How does Cinacalcet Mylan work?
Slovenian: Kako zdravilo Cinakalcet Mylan deluje?
English: Strength
Slovenian: Stična ovojnina
English: The following deficiencies were identified:
Slovenian: Odkrili sta naslednje pomanjkljivosti:
English: In addition, any significant safety events may only develop after a long period of time.
Slovenian: Poleg tega se utegnejo morebitni pomembni varnostni dogodki pojaviti šele po daljšem času.
English: SoliCol D3
Slovenian: Zdravilo SoliCol D3
English: The consistent and continuous lack of adequate quality assurance since before 2015 is therefore of serious concern.
Slovenian: Stalno in nenehno pomanjkanje ustreznega zagotavljanja kakovosti iz obdobja pred letom 2015 je zato zelo zaskrbljujoče.
English: The DHPCs should be sent in accordance with the agreed communication plan.
Slovenian: Neposredna obvestila je treba poslati v skladu z dogovorjenim načrtom sporočanja.
English: 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.
Slovenian: 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.
English: The reliability of the safety database to detect such an effect is very low.
Slovenian: Zanesljivost zbirke podatkov o varnosti zdravila je za odkrivanje takega učinka zelo majhna.
English: 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.
Slovenian: 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.
English: Nevertheless, the quality system at the manufacturing site is still significantly lacking in terms of change control and quality oversight.
Slovenian: Kljub temu pa je sistem kakovosti v proizvodnem obratu z vidika nadzora nad spremembami in nadzora nad kakovostjo še vedno zelo pomanjkljiv.
English: This is a severe condition and a significant number of patients are treated with Ammonaps in the EU.
Slovenian: To je resno stanje in v EU se z zdravilom Ammonaps zdravi precejšnje število bolnikov.