natgillin/translations-raw huggingface dataset:
It was decided that a re-inspection would be done after one year to assess the progress in eliminating the major deficiencies.
Sprejeta je bila odločitev, da bo po enem letu ponovno opravljen inšpekcijski pregled, da bi ocenili napredek pri odpravljanju bistvenih pomanjkljivosti.
A shortage of supply was expected from November 2015.
Od novembra 2015 je bilo pričakovati nezadostno oskrbo z zdravilom.
Therefore, at present the positive benefit-risk cannot be confirmed.
Iz tega razloga trenutno ni mogoče potrditi pozitivnega razmerja med koristmi in tveganji.
Several such products are available, both derived from human donor tissue and from ceramics.
Takšnih izdelkov je na voljo več, izdelani pa so tako iz tkiva darovalcev kot tudi iz keramike.
The latest batch was released in January 2015 into the EU market, thus prior to the above inspection.
Zadnja serija je bila na trg EU sproščena januarja 2015, torej pred omenjenim inšpekcijskim pregledom.
From a public health perspective, there was no indication of risks to patients linked to the inspection findings.
Z vidika javnega zdravja ni bilo nobenih znakov tveganja za bolnike, kar zadeva ugotovitve inšpekcijskega pregleda.
• The Committee reviewed all available data submitted by the MAH during the procedure under Article 20 of Regulation (EC) No 726/2004
• Odbor je pregledal vse razpoložljive podatke, ki jih je predložil imetnik dovoljenja za promet v okviru postopka v skladu s členom 20 Uredbe (ES) št. 726/2004.
The main concern identified was potential for particulate contamination.
Glavni ugotovljeni pomislek je bila nevarnost kontaminacije z delci.
CHMP opinion Whereas
Mnenja CHMP Ob upoštevanju naslednjega:
• There is no alternative manufacturing site authorised within the marketing authorisation dossier;
• v dokumentaciji dovoljenja za promet ni odobren noben nadomesten proizvodni obrat;
An Article 20 of Regulation (EC) No 726/2004 was initiated by the EC on 23 July 2015 for the above concerns and their impact on the benefit-risk balance of InductOs to be determined and to decide if the relevant marketing authorisation should be maintained, varied, suspended or revoked.
23. julija 2015 je Evropska komisija ukrepala v skladu s členom 20 Uredbe (ES) št. 726/2004 z namenom opredelitve omenjenih pomislekov in njihovega vpliva na razmerje med koristmi in tveganji zdravila InductOs ter sprejetja odločitve, ali naj se zadevno dovoljenje za promet ohrani, spremeni, začasno umakne ali ukine.
On 23 July 2015, the CHMP also adopted a list of questions to be addressed by the MAH.
23. julija 2015 je CHMP prav tako sprejel seznam vprašanj za imetnika dovoljenja za promet.
No other ‘morphogenetic proteins' (such as InductOs) are available in the EU but substances known as ‘graft extenders' reduce the required amount of bone graft (but not completely replace the grafts).
V EU ni na voljo drugih proteinov za morfogenezo (kot je zdravilo InductOs), so pa na voljo nosilni materiali, ki zmanjšujejo potrebno količino kostnega presadka (vendar presadka ne nadomestijo v celoti).
- The CHMP considers that at present the particulars and documents provided for in Article 8(3) of Directive 2001/83/EC, are incorrect;
- CHMP meni, da so podatki in dokumenti, ki so določeni v členu 8(3) Direktive 2001/83/ES, trenutno netočni;
Annex I Scientific conclusions
Priloga I
The final statement of non-compliance was issued and entered in the Community database by the Netherlands (IGZ) in accordance with Article 111 (7) of Directive 2001/83/EC on 23 July 2015.
23. julija 2015 je Nizozemska (IGZ) objavila končno izjavo o neskladnosti in jo vnesla v podatkovno zbirko Skupnosti v skladu s členom 111(7) Direktive 2001/83/ES.
The CHMP also considers that no product is recommended to be recalled from the market, as the current product on the market was released under a valid GMP certificate in January 2015.
CHMP prav tako meni, da ni treba priporočiti odpoklica nobenega izdelka s trga, saj je bil izdelek, ki je trenutno na trgu, dan na trg v skladu z veljavnim potrdilom o dobri proizvodni praksi januarja 2015.
However the CHMP also noted that although the findings may not pose a risk to patients, the sponge should not include any other unwanted components/contaminants and the MAH must undertake efforts to remove these and comply with the legal obligations.
CHMP je poleg tega menil, da kljub temu, da sodeč po ugotovitvah ni tveganj za bolnike, goba ne bi smela vključevati nobenih drugih neželenih komponent/kontaminantov ter da mora imetnik dovoljenja za promet izvesti ukrepe za njihovo odstranitev in skladnost s pravnimi obveznostmi.
This action determined that no new batches of InductOs could be produced nor released in the EU.
Ta ukrep je pomenil, da v EU ne bo možno proizvesti niti sprostiti novih serij zdravila InductOs.
InductOs, is a kit for implant, authorised centrally since 2002 for single level lumbar interbody spine fusion as a substitute for autogenous bone graft in adults with degenerative disc disease who have had at least 6 months of non-operative treatment for this condition.
Zdravilo InductOs je komplet za vsaditev, odobren po centraliziranem postopku od leta 2002 za enonivojsko interkorpusno fuzijo ledvene hrbtenice kot nadomestilo za avtogeni kostni presadek pri odraslih z degenerativno boleznijo medvretenčnih ploščic, ki so bili zaradi te bolezni vsaj 6 mesecev neoperativno zdravljeni.
As mentioned above, the April 2015 inspection found that the corrective action plan failed and the contamination of ACS with particulate matter was not under control and quality system not aiming for continuous improvement.
Kot navedeno, je bilo pri inšpekcijskem pregledu aprila 2015 ugotovljeno, da akcijski načrt s popravnimi ukrepi ni bil uspešno izveden, da možnost kontaminacije absorpcijske kolagenske gobe z delci ni pod nadzorom in da sistem kakovosti ni usmerjen v stalne izboljšave.
Consequently, the Netherlands issued a draft statement of GMP non -compliance for this manufacturer which is the only existent one.
Nizozemska je na podlagi tega objavila osnutek izjave o neskladnosti tega proizvajalca, ki je edini obstoječi proizvajalec, z dobro proizvodno prakso.
It was noted that alternative treatments are available, including the use of autogenous bone grafts, which are usually harvested from the iliac crest.
Ugotovljeno je bilo, da so na voljo alternativne možnosti, vključno z uporabo avtogenega kostnega presadka, ki se običajno pridobi iz črevničnega grebena.
On 23 July, the CHMP considered the need to take provisional measures to be applied immediately, notably a withdrawal from the market and/or suspension of the marketing authorisation, as requested by the EC.
23. julija je CHMP na zahtevo Evropske komisije obravnaval potrebo po sprejetju in takojšnjem začetku izvajanja začasnih ukrepov, in sicer umika s trga in/ali začasnega umika dovoljenja za promet.
The CHMP noted that, following the inspection in April 2015, no batches of InductOs had been released in the EU as recommended by the inspectors.
CHMP je ugotovil, da po inšpekcijskem pregledu aprila 2015 v skladu s priporočili inšpektorjev v EU niso bile sproščene nove serije zdravila InductOs.
Therefore, and taking into account the assessment of the latest PSUR for InductOs dated April 2015 showing no signals in this regard, the CHMP was of the view that there was no need to adopt provisional measures for InductOs.
Iz tega razloga in ob upoštevanju, da v oceni zadnjega rednega posodobljenega poročila o varnosti (PSUR) za zdravilo InductOs iz aprila 2015 ni bilo tovrstnih znakov, je CHMP menil, da ni potrebe po sprejetju začasnih ukrepov za zdravilo InductOs.
The CHMP, having considered all the data provided by the MAH, considers that there is no apparent identified safety concern nor seems to have risk to patients associated with the contamination of the ACS with particulate matter.
CHMP po proučitvi vseh podatkov, ki jih je predložil imetnik dovoljenja za promet, meni, da niso bili ugotovljeni nobeni očitni pomisleki glede varnosti niti tveganja za bolnike v zvezi s kontaminacijo absorpcijske kolagenske gobe z delci.
This has to be applied to the sponge which is thereafter implanted into patients.
Pripravljeno zdravilo je treba nanesti na gobo, ki se nato vsadi bolniku.
Healthcare professionals using InductOs were advised to follow the instructions in the product information as usual and a Direct Health Care Professional Communication (DHPC) was adopted and agreed to be distributed on 12 August by the MAH.
Zdravstvenim delavcem, ki uporabljajo zdravilo InductOs, je bilo svetovano, naj kot običajno upoštevajo navodila v informacijah o zdravilu, imetnik dovoljenja za promet pa je 12. avgusta sprejel neposredno obvestilo za zdravstvene delavce in se zavezal, da ga bo slednjim tudi posredoval.
InductOs is also indicated for the treatment of acute tibia fractures in adults, as an adjunct to standard care using open fracture reduction and intramedullary unreamed nail fixation.
Zdravilo InductOs je prav tako indicirano za zdravljenje akutnih zlomov golenice pri odraslih, kot dodatek standardni oskrbi z uporabo redukcije odprtega zloma in intramedularne fiksacije z nepovrtanimi žeblji.
Standard of care in the EU consists of surgical intervention using reamed or unreamed intramedullary nailing with locking screws.
Standardna oskrba v EU zajema kirurški poseg z intramedularnim žebljanjem s povrtavanjem ali brez povrtavanja in z zaklepnimi vijaki.
• Integra LifeSciences Corporation site is not in compliance with EU GMP for the manufacture of the absorbable collagen sponge (ACS), part of the medicinal product, InductOs;
• proizvodni obrat družbe Integra LifeSciences Corporation ni skladen z dobro proizvodno prakso EU za proizvodnjo absorpcijske kolagenske gobe, ki je del zdravila InductOs;
The kit consists of a powder containing the active substance, dibotermin alfa, a solvent and a matrix (absorbable collagen sponge, ACS).
Komplet vsebuje prašek z zdravilno učinkovino dibotermin alfa, vehikel in matriks (absorpcijsko kolagensko gobo).
For the suspension to be lifted, the marketing authorisation(s) holder(s) should have a valid GMP compliance statement for the manufacturer of the ACS, fulfilling the requirements set out in Article 46 of Directive 2001/83/EC.
Imetnik(i) dovoljenj(a) za promet mora(jo) za preklic umika predložiti veljavno izjavo o skladnosti proizvajalca absorpcijske kolagenske gobe z dobro proizvodno prakso, ki izpolnjuje zahteve iz člena 46 Direktive 2001/83/ES.
- The CHMP considers that the absence of GMP compliance of the manufacturing site of the absorbable collagen sponge, part of the medicinal product precludes at present the confirmation of the benefit-risk of InductOs;
- CHMP meni, da zaradi neskladnosti proizvodnega obrata za absorpcijsko kolagensko gobo z dobro proizvodno prakso del zdravila trenutno preprečuje potrditev razmerja med koristmi in tveganji zdravila InductOs;
USA), was inspected last in April 2015 by the Netherlands and Spain and found to be not compliant with the legal requirements and/or the principles and guidelines of GMP as provided for by Union law.
Pri proizvajalcu absorpcijske kolagenske gobe, družbi Integra LifeSciences Corporation (ILS) s sedežem v tretji državi (tj. v ZDA), je bil inšpekcijski pregled nazadnje opravljen aprila 2015 - pregled sta opravili Nizozemska in Španija - in ugotovljeno je bilo, da ne izpolnjuje pravnih obveznosti in/ali načel in smernic dobre proizvodne prakse, kot jih določa zakonodaja Unije.
As a consequence, the CHMP recommends the suspension of the marketing authorisation for InductOs in accordance with Article 116, second paragraph of the said Directive.
zato CHMP priporoča začasen umik dovoljenja za promet z zdravilom InductOs v skladu z drugim odstavkom člena 116 omenjene direktive.
No further product was released after the GMP non-compliance certificate was issued and the latest information on stock indicates that InductOs will be available until end of December 2015.
Po izdaji potrdila o neskladnosti z dobro proizvodno prakso ni bil na trg dan noben izdelek in zadnje informacije o zalogah kažejo, da bo zdravilo InductOs na voljo do konca decembra 2015.
The CHMP is therefore of the opinion that the marketing authorisation(s) for InductOs should be suspended in accordance with Article 116, second paragraph of the said Directive.
CHMP zato meni, da bi bilo treba dovoljenje oziroma dovoljenja za promet z zdravilom InductOs začasno umakniti v skladu z drugim odstavkom člena 116 navedene direktive.
At that time, following a corrective action plan, restricted GMP certificate valid until January 2015 was issued.
Takrat je bil oblikovan akcijski načrt s popravnimi ukrepi in izdano omejeno potrdilo o skladnosti z dobro proizvodno prakso, veljavno do januarja 2015.
For the treatment of tibia fractures, fixation with a reamed nail instead of InductOs plus unreamed nail fixation is an alternative option.
Za zdravljenje zlomov golenice je namesto kombinacije zdravila InductOs in fiksacije z nepovrtanimi žeblji alternativna možnost fiksacija s povrtanimi žeblji.
On the basis of the above and taking into account that InductOs has no alternative ACS manufacturing site authorised:
Na podlagi zgoraj navedenega in ob upoštevanju, da za zdravilo InductOs ne obstaja odobren nadomestni proizvodni obrat za absorpcijsko kolagensko gobo:
As such it is consequently inspected against EU-GMP guidelines.
Zaradi tega mora uspešno opraviti pregled skladnosti s smernicami EU za dobro proizvodno prakso.
ACS has been classified as an excipient of InductOs.
Absorpcijska kolagenska goba je opredeljena kot pomožna snov pri zdravilu InductOs.
Given the findings, the CHMP considered that the quality of InductOs cannot be assured at present due to the lack of GMP compliance of the ACS issued on 23 July 2015.
Na podlagi ugotovitev je CHMP menil, da glede na izjavo, objavljeno 23. julija 2015, o neskladnosti absorpcijske kolagenske gobe z dobro proizvodno prakso trenutno ni mogoče zagotoviti kakovosti zdravila InductOs.
Strength Pharmaceutical Form
Pot uporabe Stična ovojnina Vsebina
• Drink the liquid straight away.
• Tekočino takoj popijte.
Date of first authorisation: 2 February 2016 Date of latest renewal: 12 December 2016
Datum prve odobritve: 2. februar 2016 Datum zadnjega podaljšanja: 12. december 2016
These changes are small and not likely to be of clinical significance.
Te spremembe so majhne in ni verjetno, da bi bile klinično pomembne.
All patients received at least one prior line of therapy.
Vsi bolniki so prejeli vsaj eno predhodno linijo zdravljenja.
It may also help to reduce the size of the tumour.
Pomaga lahko tudi zmanjšati velikost tumorja.
Therefore, it is important that men also use effective contraception.
Zato je pomembno, da tudi moški uporabljajo učinkovito kontracepcijo.
Take your next normal dose at its scheduled time.
Naslednji običajni odmerek vzemite ob predvidenem času.
• you have ever had heart problems - your doctor may want to keep a close eye on you.
• če ste kdaj imeli težave s srcem - zdravnik vas bo morda želel skrbno spremljati.
• Put the tablet in a glass.
• Tableto dajte v kozarec.
This is because some medicine may remain in your body, (see advice on contraception below).
Nekaj zdravila namreč lahko ostane v telesu (glejte nasvet o kontracepciji, spodaj).
Do not give this medicine to children or adolescents under the age of 18 years.
Tega zdravila ne dajajte otrokom in mladostnikom, mlajšim od 18 let.
• You can take this medicine with or without food.
• To zdravilo lahko vzamete s hrano ali brez nje.
If you forget a dose, take it as soon as you remember it.
Če pozabite vzeti odmerek, ga vzemite, čim se spomnite.
(Findings based on test results presented as CTCAE grade shifts)
(Izsledki na podlagi rezultatov preiskav, prikazani kot premiki stopnje CTCAE)
This is more likely in areas exposed to the sun.
Te spremembe so verjetnejše na predelih, izpostavljenih soncu.
This is because it is not known if there is a risk to your baby.
Ni namreč znano, ali obstaja kakšno tveganje za otroka.
No other liquids should be added.
Drugih tekočin se ne sme dodajati.
• Stir thewater until the tablet breaks up into very small pieces -the tablet will not completely dissolve.
• Vodo mešajte, dokler se tableta ne razpusti v zelo majhne delce - tableta se ne bo popolnoma raztopila.
Your doctor will discuss appropriate treatment options with you.
Zdravnik se bo z vami pogovoril o primernih možnostih zdravljenja.
The types of adverse events reported were similar regardless of age.
Vrste poročanih neželenih učinkov so bile podobne ne glede na starost.
Of 556 patients, 200 patients had available baseline brain scans.
Od 556 bolnikov jih je 200 imelo na voljo izhodiščne posnetke možganov.
Duration of Response (DoR)
Trajanje odziva (DoR)
If you are able to become pregnant, you must use effective contraception.
Če bi lahko zanosili, morate uporabljati učinkovito kontracepcijo.
See ‘Contraception - information for women and men' below.
Glejte “Kontracepcija - informacije za ženske in moške”, spodaj.
Do not stop taking this medicine - talk to your doctor first.
Ne prenehajte jemati tega zdravila - najprej se posvetujte z zdravnikom.
Represents the incidence of laboratory findings, not of reported adverse events.
Predstavlja pojavnost laboratorijskih izvidov, ne poročanih neželenih učinkov.
• Add 50 mL (about two-thirds of a tumblerful) of still (non-fizzy) water - do not use any other liquids.
• Dodajte 50 ml (približno dve tretjini kozarca) vode (brez mehurčkov) - ne uporabljajte nobenih drugih tekočin.
• Do not use any pack that is damaged or shows signs of tampering.
• Ne uporabite pakiranj, ki so poškodovana ali kažejo znake, da jih je že kdo odpiral.
TAGRISSO can be taken with or without food at the same time each day.
Zdravilo TAGRISSO je mogoče vzeti s hrano ali brez nje, vsak dan ob istem času.
Contraception - information for women and men You must use effective contraception during treatment.
Kontracepcija - informacije za ženske in moške Med zdravljenjem morate uporabljati učinkovito kontracepcijo.
It is important to take this medicine every day, for as long as your doctor prescribes it for you.
Pomembno je, da to zdravilo jemljete vsak dan toliko časa, kot vam predpiše zdravnik.
Because of this defect, other protein kinase medicines may no longer work.
Zaradi te napake se lahko zgodi, da drugi zaviralci protein-kinaze ne delujejo več.
Reintroduction of TAGRISSO should be considered only after careful consideration of the individual patient's benefits and risk.
Ponovna uvedba zdravila TAGRISSO pride v poštev le po skrbnem pretehtanju koristi in tveganj pri posameznem bolniku.
However, with current available data, alternative metabolic pathways cannot be fully ruled out.
Vseeno pa s podatki, ki so trenutno na voljo, ni možno izključiti alternativnih metabolnih poti.
• To make sure you have taken all of the medicine, rinse the glass thoroughly with another 50 mL of water and drink it.
• Da boste zaužili zares vse zdravilo, kozarec dobro splaknite z dodatnimi 50 ml vode in jo popijte.
Most cases improved or resolved with interruption of treatment.
Večina primerov se je po prenehanju zdravljenja izboljšala ali je izginila.
• you have severe peeling of your skin.
• če imate hudo luščenje kože.
Discuss with your doctor the most appropriate methods of contraception.
zdravnikom se posvetujte o najprimernejših načinih kontracepcije.
A risk for decreased exposure of hormonal contraceptives cannot be excluded.
Tveganja za manjšo izpostavljenost hormonskim kontraceptivom ni mogoče izključiti.
• Take TAGRISSO every day at the same time.
• Zdravilo TAGRISSO vzemite vsak dan ob istem času.
Before initiating treatment, patients should be advised of signs and symptoms of SJS.
Pred uvedbo zdravljenja je treba bolnike seznaniti z znaki in simptomi SJS.
Randomisation was stratified by ethnicity (Asian and non-Asian).
Randomizacija je bila stratificirana po etnični pripadnosti (azijsko in neazijsko poreklo).
Appetite Loss
Izguba apetita
• Oral hormonal contraceptive pill- used to prevent pregnancy.
• peroralne hormonske kontracepcijske tablete - uporabljajo se za preprečevanje nosečnosti.
• you have sudden difficulty in breathing together with a cough or fever.
• če se vam nenadoma pojavi težko dihanje skupaj s kašljem ali vročino.
Assessment of EGFR mutation status
Ocena stanja mutacije EGFR
Tell your doctor if your skin or nail problems get worse.
Zdravnika morate obvestiti, če se vam težave s kožo ali nohti poslabšajo.
Pregnancy - information for women
Nosečnost - informacije za ženske
Age and body weight
Starost in telesna masa
• Reduction in the number of white blood cells (leukocytes, lymphocytesor neutrophils).
• Zmanjšanje števila belih krvnih celic (levkocitov, limfocitov ali nevtrofilcev).
Close monitoring is recommended in these patients (see section 4.8).
Pri teh bolnikih je priporočeno skrbno spremljanje (glejte poglavje 4.8).
Based on unconfirmed response
Na podlagi nepotrjenega odziva.
Dose reduction was required in 0.2% of patients and dose interruption in 1.4%.
Zmanjšanje odmerka je bilo potrebno pri 0,2 % bolnikov, prekinitev uporabe pa pri 1,4 % bolnikov.
Compliance over the first 9 months was generally high (≥70%) and similar in both arms.
Sodelovanje bolnikov je bilo v prvih 9 mesecih na splošno visoko (≥ 70 %) in v obeh skupinah podobno.
QTc interval prolongation
Podaljšanje intervala QTc
• The recommended dose is one 80 mg tablet each day.
• Priporočeni odmerek je ena 80 mg tableta vsak dan.
TAGRISSO should not be used during pregnancy unless the clinical condition of the woman requires treatment with osimertinib.
Zdravila TAGRISSO se med nosečnostjo ne sme uporabljati, razen če klinično stanje bolnice zahteva zdravljenje z osimertinibom.
• you have a history of eye problems.
• če ste kdaj imeli težave z očmi.
An additional half a glass of water should be added to ensure that no residue remains and then immediately swallowed.
Dodati mora še dodatnega pol kozarca vode in tako zagotoviti, da ne ostane nič zdravila; dodatno vodo mora takoj popiti.
• Reduction in the number of platelets in the blood.
• Zmanjšanje števila trombocitov v krvi.
The safety and efficacy of this medicinal product has not been established in patients with severe hepatic impairment.
Varnost in učinkovitost tega zdravila nista ugotovljeni pri bolnikih s hudo okvaro jeter.
Patients should be advised to use effective contraception for the following periods after completion of treatment with this medicinal product: at least 2 months for females and 4 months for males.
Bolnicam oz. bolnikom je treba naročiti, da morajo uporabljati učinkovito kontracepcijo tudi še po koncu zdravljenja s tem zdravilom, in sicer ženske vsaj še 2 meseca in moški še 4 mesece.
These findings were seen at clinically relevant plasma concentrations.
To so opažali ob klinično pomembnih plazemskih koncentracijah.
Most adverse reactions were Grade 1 or 2 in severity.
Večina neželenih učinkov je bila glede na resnost 1. ali 2. stopnje.
Osimertinib is eliminated mainly via the liver.
Osimertinib se izloča predvsem preko jeter.
TAGRISSO works by blocking EGFR and may help to slow or stop your lung cancer from growing.
Zdravilo TAGRISSO deluje tako, da zavira EGFR in lahko pomaga upočasniti ali ustaviti rast pljučnega raka.
Discontinuation due to adverse reactions was 4.3%.
Ukinitev uporabe zdravila zaradi neželenih učinkov je bilo 4,3 %.
If you take more TAGRISSO than you should If you take more than your normal dose, contact your doctor or nearest hospital straight away.
Če ste vzeli večji odmerek zdravila TAGRISSO, kot bi smeli Če vzamete odmerek, večji od običajnega odmerka, se nemudoma posvetujte z zdravnikom ali pojdite v najbližjo bolnišnico.
CIOMS descriptor/ overall frequency (all CTCAE grades)
Izraz po MedDRA Deskriptor CIOMS/celotna pogostnost (vse stopnje CTCAE)
The recommended dose is 80 mg osimertinib once a day until disease progression or unacceptable toxicity.
Priporočeni odmerek je 80 mg osimertiniba enkrat na dan do napredovanja bolezni ali nesprejemljivih toksičnih učinkov.
Effects of osimertinib on P-gp and BCRP
Vplivi osimertiniba na P-gp in BCRP
Overall survival data were not mature at the time of this initial OS analysis.
Podatki o celokupnem preživetju ob času te uvodne analize celokupnega preživetja še niso bili dozoreli.