natgillin/translations-raw huggingface dataset:
How to store Abraxane
Shranjevanje zdravila Abraxane
Survival (months) Progression-free Survival Death or progression, n (%) Median Progression-free Survival, months (95% CI) HRA+G/G (95% CI)a P-valueb
Preživetje brez napredovanja bolezni Smrt ali napredovanje bolezni, n (%) Mediana preživetja brez napredovanja bolezni, meseci (95 % IZ)
• Abraxane is used together with a medicine called gemcitabine if you have metastatic cancer of the pancreas.
• Če imate metastatskega raka trebušne slinavke (pankreasa), se zdravilo Abraxane uporablja skupaj z zdravilom, ki se imenuje gemcitabin.
Population pharmacokinetic analysis for Abraxane included patients with ages ranging from 24 to 85 years old and shows that age does not significantly influence the maximum elimination rate and systemic exposure (AUC and Cmax) of paclitaxel.
Analiza kaže, da starost ne vpliva značilno na največjo hitrost izločanja paklitaksela in sistemsko izpostavljenost paklitakselu (AUC in Cmax).
Reduce doses 2 dose levels from Day 1 doses
Zmanjšajte odmerke za eno raven, nato dajte rastne faktorje belih krvnih celic ALI Zmanjšajte odmerke za dve ravni od odmerkov 1. dne
Grade 4 cutaneous toxicity, diarrhoea, or mucositis
Ukinite zdravljenje kožna toksičnost, driska ali mukozitis 4. stopnje prvo
Table 11: Efficacy results from randomized study in patients with pancreatic adenocarcinoma (Intent-to-treat population)
Preglednica 11: Rezultati učinkovitosti iz randomizirane študije pri bolnikih z adenokarcinomom trebušne slinavke (populacija z namenom zdravljenja) Zdravilo Abraxane (125 mg/m2)/gemcitabin (N=431)
• Indigestion, abdominal discomfort
• prebavne motnje, nelagodje v trebuhu
• Coughing with phlegm, shortness of breath when walking or climbing stairs, runny nose, or dry nose, decreased breath sounds, water on the lung, loss of voice, blood clot in the lung, dry throat
plitvejši zvok dihanja, voda v pljučih, izguba glasu, krvni strdek v pljučih, suho žrelo
patients with metastatic breast cancer.
minutno infuzijo pri 63 bolnikih z metastatskim rakom dojk.
Common: Stomatitis, dyspepsia, abdominal pain, dysphagia Hepatobiliary disordesrs Common: Hyperbilirubinaemia Skin and subcutaneous tissue disorders
Pogosti: bolečine v trebuhu, abdominalna distenzija, bolečine v zgornjem predelu trebuha, dispepsija, gastroezofagealna refluksna bolezen, oralna hipoestezija
Common: Pneumonia, bronchitis, upper respiratory tract infection, urinary tract infection
Pogosti: pljučnica, bronhitis, okužba zgornjih dihal, okužba sečil Občasni: sepsa, oralna kandidoza
Nadir platelets <50,000/mm3
Ukinite zdravljenje najmanjše število trombocitov <50.000/mm3
Resume Abraxane at reduced dose when peripheral neuropathy improves to Grade 0 or 1 (see section 4.2).
Ko se periferna nevropatija izboljša na 0. ali 1. stopnjo, nadaljujte zdravljenje z zmanjšanim odmerkom zdravila Abraxane (glejte poglavje 4.2).
Very common: Nausea, diarrhoea, vomiting, constipation, stomatitis Common: Abdominal pain, abdominal distension, upper abdominal pain, dyspepsia, gastrooesophageal reflux disease, oral hypoaesthesia Uncommon: Dysphagia, flatulence, glossodynia, dry mouth, gingival pain, loose stools, oesophagitis, lower abdominal pain, mouth ulceration, oral pain, rectal haemorrhage
Občasni: disfagija, flatulenca, glosodinija, suha usta, boleče dlesni, mehko blato, ezofagitis, bolečine v spodnjem delu trebuha, ulceracija ust, bolečine v ustih, rektalno krvavenje
Very common: Insomnia, depression Common: Anxiety
Zelo pogosti: dehidracija, zmanjšan apetit, hipokaliemija Psihiatrične motnje Zelo pogosti: nespečnost, depresivnost Pogosti: anksioznost
95% CI
Preživetje % (95 % IZ) pri
Survival Rate % (95% CI) at 1 Year 2 Year 75th Percentile Overall
75. percentil celokupnega preživetja (meseci)
Return to the Day 1 dose levels and follow with WBC Growth Factors OR Treat with same doses as Day 8 ≥ 500 but < 1000 OR ≥ 50,000 but < 75,000 Treat with Day 8 dose levels and follow with WBC Growth Factors OR Reduce doses 1 dose level from Day 8 doses
Zdravite z ravnijo odmerka 8. dne, nato dajte rastne faktorje belih krvnih celic ALI Zmanjšajte odmerke za eno raven od odmerkov 8. dne
The common side effects may affect up to 1 in 10 people:
Pogosti neželeni učinki se lahko pojavijo pri največ 1 od 10 bolnikov:
Common: Haemoptysis, epistaxis, cough
Pogosti: hemoptiza, epistaksa, kašelj Občasni: pnevmonitis3
Scleroderma of the skin has been reported.
Poročali so osklerodermiji.
Abraxane.
fenitoin)
The clinical study report should be submitted to the relevant National Competent Authorities by:
Poročilo o klinični študiji je treba predložiti ustreznemu pristojnemu nacionalnemu organu do:
The study population should be representative for the authorised indication(s).
Študijska populacija mora biti reprezentativna za odobreno(-e) indikacijo(-e).
The protocols should be agreed with the relevant NCAs.
O protokolih se je treba dogovoriti s pristojnimi nacionalnimi organi.
Each MAH shall conduct and submit for their medicinal product(s) the results of placebo-controlled, double-blind multicentre RCT(s) according to agreed protocols in order to further characterise the efficacy and safety, of their bacterial lysate based product(s) in their authorised indication(s).
Vsak imetnik dovoljenja za promet z zdravilom mora za nadaljnjo opredelitev učinkovitosti in varnosti svojih zdravil na osnovi bakterijskih lizatov pri odobreni(-h) indikaciji(-ah) izvesti s placebom nadzorovana, dvojno slepa, multicentrična randomizirana klinična preskušanja po dogovorjenih protokolih in predložiti njihove rezultate.
The marketing authorisation holders shall complete the below condition, within the stated timeframe, and competent authorities shall ensure that the following is fulfilled:
Imetniki dovoljenja za promet z zdravilom izpolnijo spodnji pogoj v navedenem roku, pristojni organi pa zagotovijo, da je izpolnjeno naslednje:
The product is currently approved in Sweden, Denmark, Finland, Iceland and Norway.
Zdravilo je trenutno odobreno na Švedskem, Danskem, Finskem, Islandiji in Norveškem.
This program is on-going and overall from 01 September 2009 to 30 June 2011, 12,830 women have been exposed.
Ta program še poteka in od 1. septembra 2009 do 30. junija 2011 je bilo zdravljenju izpostavljenih 12 830 žensk.
This protocol has been designed to provide further reassurance of the safety and efficacy of the product.
Ta protokol je bil zasnovan tako, da dodatno zagotovi varnost in učinkovitost zdravila.
The success rate is of 97.3%, comparable to studies reported in published literature.
Stopnja uspešnosti je bila 97,3 %, kar je primerljivo s študijami, o katerih poročajo v objavljeni literaturi.
The results of these trials show a very high success rate and no unexpected adverse events.
Rezultati teh preskušanj so pokazali zelo visoko stopnjo uspešnosti in nič nepričakovanih neželenih dogodkov.
• The Committee considered the notification of the referral triggered by France under Article 29(4) of Council Directive 2001/83/EC;
• Odbor je obravnaval obvestilo o napotitvenem postopku, ki jo je sprožila Francija v skladu s členom 29(4) Direktive Sveta 2001/83/ES.
For the 12,830 women who have received this treatment via the program, the efficacy and safety of the method was as expected from clinical studies reported in the literature.
Za 12 830 žensk, ki so v okviru tega programa prejele to zdravilo, sta bili učinkovitost in varnost te metode pričakovani iz kliničnih študij, o katerih so poročali v literaturi.
Overall summary of the scientific evaluation of Mifepristone Linepharma and associated names (see Annex I)
Splošni povzetek znanstvenega vrednotenja zdravila Mifepristone Linepharma in povezanih imen (glejte Prilogo I)
The clinical trials have been performed in co-operation with two organisations which have administered the medicinal product to a large number of women.
Klinična preskušanja so izvedli v sodelovanju z dvema organizacijama, ki sta zdravilo dali velikemu številu žensk.
- The second organisation (Marie Stopes International Australia) has set up a pre-launch training program in Australia under Therapeutic Goods Administration (TGA) Authorised Prescriber Program.
- Druga organizacija (Marie Stopes International Australia) je vzpostavila izobraževalni program pred izvajanjem študije v Avstraliji v okviru programa pooblaščenih predpisovalcev (Authorised Prescriber Program) Uprave za terapevtske proizvode (Therapeutic Goods Administration, TGA).
Bioequivalence with the reference product (Mifegyne) was demonstrated for AUC while the Cmax was slightly above the conventional acceptance range of 80-125% (the Cmax ratio (90% CI) was 114.4 (103.33-126.66)).
Biološka enakovrednost z referenčnim zdravilom (Mifegyne) je bila dokazana za AUC, medtem ko je bil Cmax nekoliko nad običajnim razponom sprejemljivosti 80-125 % (razmerje Cmax (90-odstotni IZ) je bil 114,4 (103,33-126,66)).
• The Committee reviewed all available data submitted by the marketing authorisation holder to address the potential serious risk to public health, in particular the efficacy and safety in respect of the 200 mg Mifepristone Linepharma dosing regimen;
• Odbor je preučil vse razpoložljive podatke, ki jih je predložil imetnik dovoljenja za promet z zdravilom, da obravnava možno resno tveganje za javno zdravje, zlasti učinkovitost in varnost režima 200 mg odmerjanja zdravila Mifepristone Linepharma.
During the repeat use procedure potential serious risk to public health was raised by the France as bioequivalence with the reference product had not been demonstrated for Cmax.
Med postopkom ponovne uporabe je Francija izpostavila možno resno tveganje za javno zdravje, saj biološka enakovrednost z referenčnim zdravilom za Cmax ni bila dokazana.
(complete termination, no need for additional surgical procedure) was 96.7%.
V celotni populaciji je bila stopnja učinkovitosti (popolni splav brez potrebe po dodatnem kirurškem posegu) 96,7 %.
In addition, the CHMP noted that the study with Mifeprex demonstrates bioequivalence for both AUC and Cmax.
CHMP je opomnil tudi, da je študija z zdravilom Mifeprex dokazala biološko enakovrednost za AUC in za Cmax.
Some other specific methodological comments were also raised by the CHMP such as representativity of prescribers, sample size and inclusion criteria.
CHMP je izpostavil tudi nekaj opomb, specifičnih za metodologijo, kot so reprezentativnost predpisovalcev zdravila, velikost vzorca in vključitveni kriteriji.
The clinical documentation submitted by the MAH to support this article 10(3) application includes clinical data and supportive pharmacokinetic data in the form of two bioequivalence studies.
Klinična dokumentacija, ki jo je imetnik dovoljenja za promet z zdravilom predložil v podporo tej vlogi v skladu s členom 10(3), vključuje klinične podatke in podporne farmakokinetične podatke v obliki dveh študij biološke enakovrednosti.
• The Committee considered that the overall efficacy and safety have been proven by the studies presented ;
• Odbor je menil, da so predložene študije dokazale splošno učinkovitost in varnost zdravila.
The marketing authorisation holder has provided clinical efficacy and safety data from 2 studies, performed both with Mifepristone Linepharma in Mexico and Australia respectively.
Imetnik dovoljenja za promet z zdravilom je predložil podatke o klinični učinkovitosti in varnosti iz dveh študij, opravljenih z zdravilom Mifepristone Linepharma v Mehiki in Avstraliji.
No serious unexpected events were related to the regimen studied.
S preučevanim režimom uporabe niso bili povezani resni neželeni dogodki.
The posology is different to the reference product Mifegyne.
Odmerjanje se razlikuje od referenčnega zdravila Mifegyne.
The application for Mifepristone Linepharma 200 mg tablets is a hybrid application made according to Article 10(3) of Directive 2001/83/EC, with Mifegyne 200 mg tablet as reference product.
Vloga za zdravilo Mifepristone Linepharma 200 mg tablete je hibridna vloga v skladu s členom 10(3) Direktive 2001/83/ES, z zdravilom Mifegyne 200 mg tablete kot referenčnim zdravilom.
In addition, the MAH provided supportive pharmacokinetic data in the form of two bioequivalence studies.
Imetnik dovoljenja za promet je predložil tudi podporne farmakokinetične podatke v obliki dveh študij biološke enakovrednosti.
Scientific conclusions and grounds for positive opinion subject to condition to the marketing authorisation and amendment of the summary of product characteristics and package leaflet presented by the European Medicines Agency
Znanstveni zaključki in podlaga za pozitivno mnenje v skladu s pogoji za dovoljenje za promet z zdravilom in spremembo povzetka glavnih značilnosti zdravila in navodila za uporabo, ki jih je predstavila Evropska agencija za zdravila
During the following CMDh-referral procedure no consensus was reached and the CMDh referred the matter to the CHMP through an article 29(4) referral procedure.
V naslednjem napotitvenem postopku usklajevalna skupina za postopek z medsebojnim priznavanjem in decentralizirani postopek za zdravila v humani medicini (CMDh) ni dosegla soglasja, zato je CMDh zadevo predložila odboru CHMP v okviru napotitvenega postopka v skladu s členom 29(4).
The two bioequivalence studies were performed against Mifegyne (approved in EEA) and Mifeprex (approved in the USA).
Študiji biološke enakovrednosti sta bili izvedeni z zdravilom Mifegyne (odobrenim v EGP) in zdravilom Mifeprex (odobrenim v ZDA) kot referenčnima zdraviloma.
However the CHMP expressed some remaining concerns with regards to the required investigations on the potential risk of off label use of mifepristone, either using a higher dose or a combination with another prostaglandin analogue than gemeprost per vaginam.
Vendar pa je CHMP izrazil nekaj preostalih skrbi glede potrebnih raziskav o možnem tveganju uporabe zdravila mifepristone, ki ni v skladu z odobrenimi indikacijami, bodisi z uporabo previsokih odmerkov ali v kombinaciji z drugim analogom prostaglandina in ne z vaginalno uporabo gemeprosta.
Based on the results of the 2 clinical studies and taking into consideration that Mifepristone Linepharma is only given once and as a single dose, the CHMP was of the opinion that the higher Cmax would not affect safety or efficacy of Mifepristone Linepharma.
Na podlagi rezultatov iz 2 kliničnih študij in ob upoštevanju, da se zdravilo Mifepristone Linepharma uporabi le enkrat in kot enkratni odmerek, je bil CHMP mnenja, da višji Cmax ne vpliva na varnost ali učinkovitost zdravila Mifepristone Linepharma.
The reason for this alternative was the fact that the combination of 200 mg mifepristone with oral misoprostol was associated with a potentially higher risk of continuing pregnancy, whereas 1mg gemeprost vaginally had been demonstrated in many studies to provide a strong prostaglandin action also in combination with a lower dose of mifepristone.
Razlog za to alternativo je dejstvo, da je kombinacija 200 mg zdravila mifepristone s peroralnim misoprostolom povezana z možnim višjim tveganjem za nadaljevanje nosečnosti, pri vaginalni uporabi 1 mg gemeprosta pa so številne študije pokazale močno delovanje prostaglandina tudi v kombinaciji z nižjim odmerkom zdravila mifepristone.
- The organisation Gynuity Health Projects performed a GCP-compliant study in Mexico in 1000 women (open-label, non-comparative, prospective multi-site study of mifepristone 200 mg followed 24-48 hours later by buccal misoprostol 800 mcg for termination of pregnancy through 63 days).
- Organizacija Gynuity Health Projects je v Mehiki izvedla študijo v skladu z dobro klinično prakso, v kateri je sodelovalo 1000 žensk (odprta, neprimerjalna, prospektivna študija v več centrih z zdravilom mifepristone 200 mg, ki mu je po 24-48 urah sledila bukalna uporaba misoprostola 800 µg za prekinitev nosečnosti do vključno s 63. dnem).
Based on the above, in view of the slightly increased Cmax, the CHMP is of the opinion that a higher dose than 200mg of Mifepristone Linepharma should not be administered and that this should be clearly indicated in the Product Information and a prospective observational study aiming to evaluate the prescription recommendations of Mifepristone Linepharma for early pregnancy termination should be performed.
Na podlagi zgoraj navedenega in ob upoštevanju nekoliko povišanega Cmax je CHMP mnenja, da se ne sme uporabiti odmerka zdravila Mifepristone Linepharma, višjega kot 200 mg, kar je treba jasno navesti v informacijah o zdravilu, opraviti pa je treba tudi prospektivno opazovalno študijo z namenom oceniti priporočila za predpisovanje zdravila Mifepristone Linepharma za zgodnjo prekinitev nosečnosti.
Compared to Mifegyne, which could be administered either at a high dose of 600 mg or a lower dose of 200 mg, only the lower dose of 200 mg is approved for Mifepristone Linepharma.
V primerjavi z zdravilom Mifegyne, ki se lahko uporabi v visokem odmerku 600 mg ali nižjem odmerku 200 mg, je za zdravilo Mifepristone Linepharma odobren le nižji odmerek 200 mg.
The posology of Mifepristone Linepharma is not the same as for the reference product Mifegyne.
Zdravilo Mifepristone Linepharma se ne odmerja enako kot referenčno zdravilo Mifegyne.
The marketing authorisation holder was in agreement with the amendments of the section 4.2 of the SmPC and section 3 of the Package Leaflet as proposed by the CHMP.
Imetnik dovoljenja za promet z zdravilom se je strinjal s spremembami poglavja 4.2 povzetka glavnih značilnosti zdravila in poglavja 3 navodila za uporabo, ki jih je predlagal CHMP.
Taking into consideration that Mifepristone Linepharma is only given once and as a single dose of 200mg, the CHMP is of the opinion that the provided clinical data supports that the slightly higher Cmax would not affect efficacy and safety of Mifepristone Linepharma.
Ob upoštevanju, da se zdravilo Mifepristone Linepharma uporabi le enkrat kot enkratni odmerek 200 mg, je CHMP mnenja, da predloženi klinični podatki podpirajo, da nekoliko višji Cmax ne vpliva na varnost in učinkovitost zdravila Mifepristone Linepharma.
Based on the above, the CHMP considers that the overall efficacy and safety profile of the Mifepristone Linepharma has been sufficiently proven by the studies presented and therefore concluded that the benefit-risk balance for Mifepristone Linepharma in the applied indication “Medical termination of a developing intra-uterine pregnancy in sequential combination with a prostaglandin analogue up to 63 days of amenorrhea” is favourable.
Na podlagi zgoraj navedenega CHMP meni, da je splošni profil učinkovitosti in varnosti za zdravilo Mifepristone Linepharma v zadostni meri dokazan v predloženih študijah, in je zato sklenil, da je razmerje med koristmi in tveganji za zdravilo Mifepristone Linepharma za navedeno indikacijo „umetna prekinitev poteka intrauterine nosečnosti v okviru zaporedne uporabe v kombinaciji z analogom prostaglandina (gemeprostom ali mizoprostolom) do 63. dneva amenoreje” pozitivno.
Hence the CHMP is of the opinion that a revised protocol should be submitted to the national competent authorities, for final agreement prior the start of the clinical trial, as a condition to the marketing authorisation.
Zato je CHMP mnenja, da je treba pred začetkom kliničnega preskušanja pristojnim nacionalnim organom predložiti revidiran protokol za dokončno potrditev, kar je pogoj za pridobitev dovoljenja za promet z zdravilom.
The fact that buccal misoprostol and not vaginal gemeprost (as proposed in the current application) was used as follow up treatment would, if anything, lower the success rates and therefore is reassuring to the CHMP.
Stopnjo uspeha bi zmanjšalo le dejstvo, da je bila za nadaljevanje zdravljenja uporabljena bukalna oblika misoprostola in ne vaginalna oblika gemeprosta (kot predlaga trenutna vloga), zato so bili rezultati za CHMP pomirjujoči.
Women were entitled to be treated with 200 mg of Mifepristone Linepharma orally followed by 800 μg of misoprostol if their pregnancy age was 63 days of amenorrhea or less.
Ženske so izpolnjevale kriterije za peroralno zdravljenje z 200 mg zdravila Mifepristone Linepharma, ki mu je sledilo 800 μg misoprostola, če je nosečnost trajala 63 dni amenoreje ali manj.
A preliminary publication in 1343 women has been provided by the MAH.
Imetnik dovoljenja za promet z zdravilom je predložil predhodno objavo za 1 343 žensk.
The approved indication for Mifepristone Linepharma through the initial Mutual Recognition Procedure is “Medical termination of a developing intra-uterine pregnancy in sequential combination with a prostaglandin analogue up to 63 days of amenorrhea”.
Indikacija za zdravilo Mifepristone Linepharma, odobrena v okviru prvotnega postopka z medsebojnim priznavanjem, je „umetne prekinitve poteka intrauterine nosečnosti v okviru zaporedne uporabe v kombinaciji z analogom prostaglandina (gemeprostom ali mizoprostolom) do 63. dneva amenoreje”.
Grounds for positive opinion subject to condition to the marketing authorisation and amendment of the summary of product characteristics and package leaflet
Podlaga za pozitivno mnenje v skladu s pogoji za dovoljenje za promet z zdravilom in spremembo povzetka glavnih značilnosti zdravila in navodila za uporabo
The CHMP is of the opinion that the marketing authorisation holder should submit a revised protocol to the national competent authorities, for final agreement prior the start of the clinical trial.
CHMP je mnenja, da mora imetnik dovoljenja za promet z zdravilom pred začetkom kliničnega preskušanja pristojnim nacionalnim organom predložiti revidiran protokol za dokončno potrditev.
• Therefore the Committee concluded that the benefit-risk balance for Mifepristone Linepharma in the applied indications is favourable, the CHMP has recommended the granting of the marketing authorisation subject to a recommended condition with regard to the safe and effective use of the medicinal product as set out in Annex IV and for which the amended sections of the summary of product characteristics and package leaflet are set out in Annex III for Mifepristone Linepharma and associated names (see Annex I).
je CHMP priporočil, da se odobri dovoljenje za promet z zdravilom pod pogojem upoštevanja priporočila za varno in učinkovito uporabo zdravila, navedenega v Prilogi IV, pri čemer so spremenjena poglavja povzetka glavnih značilnosti zdravila in navodila za uporabo navedena v Prilogi III zdravila Mifepristone Linepharma in povezana imena (glejte Prilogo I).
Mifepristone Linepharma is submitted as a hybrid application.
Za zdravilo Mifepristone Linepharma je bila vložena hibridna vloga.
Compared to Mifegyne, which can be administered either at a high dose of 600 mg or a lower dose of 200 mg, only the lower dose of 200 mg was approved for Mifepristone Linepharma through the first wave of the Mutual Recognition Procedure and was also being proposed in the current MRP repeated procedure.
V primerjavi z zdravilom Mifegyne, ki se lahko uporabi kot visok odmerek 600 mg ali nizek odmerek 200 mg, je bil za zdravilo Mifepristone Linepharma v okviru prvega vala postopka z medsebojnim priznavanjem odobren le nižji odmerek 200 mg, ki je predlagan tudi za ponovno uporabo postopka z medsebojnim priznavanjem.
As proposed by the MAH at the time of the CMDh referral procedure, the protocol for the prospective observational study aimed to evaluate the prescription recommendations of Mifepristone Linepharma for early pregnancy termination was reviewed by the CHMP during the referral procedure.
Kot je predlagal imetnik dovoljenja za promet z zdravilom v času napotitvenega postopka CMDh, je protokol prospektivne opazovalne študije za ocenitev priporočil za predpisovanje zdravila Mifepristone Linepharma za zgodnjo prekinitev nosečnosti v okviru napotitvenega postopka pregledal CHMP.
In addition, a prospective observational study aiming to evaluate the prescription recommendations of Mifepristone Linepharma for early pregnancy termination should be performed;
Dodatno je treba izvesti prospektivno opazovalno študijo z namenom oceniti priporočila za predpisovanje zdravila Mifepristone Linepharma za zgodnjo prekinitev nosečnosti.