natgillin/translations-raw huggingface dataset:
Uncommon: Productive cough, exertional dyspnoea, sinus congestion, decreased breath sounds, pleural effusion, allergic rhinitis, hoarseness, nasal congestion, nasal dryness, wheezing, pulmonary emboli, pulmonary thromboembolism 
Občasni: produktiven kašelj, dispneja ob naporu, kongestija sinusov, plitvejši zvok dihanja, plevralni izliv, alergijski rinitis, hripavost, zamašitev nosu, suhost v nosu, piskanje v pljučih, pljučna embolija, pljučna trombembolija
Powder for suspension for infusion. 
FARMACEVTSKA OBLIKA prašek za suspenzijo za infundiranje
Lung Cancer 
Pljučni rak
Table 5: Dose reductions for non-haematologic toxicities in patients with non-small cell lung cancer Non-haematologic Toxicity 
Preglednica 5: Zmanjšanje odmerka zaradi hematoloških toksičnosti pri bolnikih z nedrobnoceličnim pljučnim rakom
The rare side effects may affect up to 1 in 1,000 people: 
Redki neželeni učinki se lahko pojavijo pri največ 1 od 1.000 bolnikov:
A multicenter, randomized, open-label study was conducted in 1052 chemotherapy-naive patients with Stage IIIb/IV non-small cell lung cancer. 
Pri 1.052 bolnikih z nedrobnoceličnim pljučnim rakom stadija IIIb/IV, ki prej še niso prejeli kemoterapije, so opravili multicentrično, randomizirano, odprto študijo.
(PT at Risk) 
(navedeno v poglavju 6),
Each vial contains 100 mg or 250 mg of paclitaxel formulated as albumin bound nanoparticles. 
Ena viala vsebuje 100 mg ali 250 mg paklitaksela, vezanega na albuminske nanodelce.
Very common: Alopecia, rash Common: Pruritus, dry skin, nail disorder, flushing 
Zelo pogosti: alopecija, izpuščaj Pogosti: pruritus, suha koža, bolezni nohtov, zardevanje
Common: Flushing, hot flushes, hypertension, lymphoedema Uncommon: Hypotension, peripheral coldness, orthostatic hypotension Rare: Thrombosis 
Pogosti: zardevanje, vročinski oblivi, hipertenzija, limfedem Občasni: hipotenzija, občutek perifernega mrazenja, ortostatska hipotenzija
The very rare side effects may affect up to 1 in 10,000 people: 
Zelo redki neželeni učinki se lahko pojavijo pri največ 1 od 10.000 bolnikov:
Patients received a median treatment duration of 3.9 months in the Abraxane/gemcitabine arm and 2.8 months in the gemcitabine arm. 32% of patients in the Abraxane/gemcitabine arm compared with 15% of patients in the gemcitabine arm received 6 or more months of treatment. 
V skupini z zdravilom Abraxane/gemcitabinom je 32 % bolnikov prejelo 6 ali več mesecev zdravljenja, v skupini z gemcitabinom pa 15 %.
Hepatobiliary disorders Common: Cholangitis 
Občasni: hepatomegalija
Solventbased paclitaxel was administered to patients (N=531) at a dose of 200 mg/m2 as an intravenous infusion over 3 hours with standard premedication, immediately followed by carboplatin administered intravenously at AUC = 6 mg•min/mL. 
Paklitaksel na bazi topila so bolnikom (N=531) dali v odmerku 200 mg/m2 v obliki intravenske infuzije, ki je tekla 3 ure, s standardno premedikacijo, takoj nato je sledil
What Abraxane contains 
Kaj vsebuje zdravilo Abraxane
Warnings and precautions Talk to your doctor or nurse before using Abraxane 
Pred začetkom uporabe zdravila Abraxane se posvetujte z zdravnikom ali medicinsko sestro
*Median progression free survival [95% CI] (weeks) 
*Mediana preživetja brez napredovanja bolezni [95 % IZ] (tedni)
Platelet count (cells/mm3) 
Število krvnih ploščic (celice/mm3)
• Anxiety 
• nemirnost
Pneumonitis has been reported at a rate of 4% with the use of Abraxane in combination with gemcitabine. 
Pnevmonitis se je pojavil pri 4 % bolnikov, kadar so bolniki prejemali zdravilo Abraxane skupaj z gemcitabinom.
Reproductive system and breast disorders 
Infekcijske in parazitske bolezni
Common: Vertigo Uncommon: Ear pain, tinnitus 
Pogosti: vrtoglavica Občasni: bolečine v ušesih, tinitus
• Pain in the breast 
• bolečine v prsih
Each vial contains 250 mg of paclitaxel formulated as albumin bound nanoparticles. 
Ena viala vsebuje 250 mg paklitaksela, vezanega na albuminske nanodelce.
Thus patients receiving Abraxane should be vigilantly monitored by physicians for the occurrence of cardiac events. 
Zaradi pojavljanja težav pri delovanju srca morajo biti bolniki, ki jemljejo zdravilo Abraxane, pod strogim nadzorom zdravnikov.
Cranial nerve palsies, vocal cord paresis, and rare reports of severe hypersensitivity reactions have been reported during post-marketing surveillance of Abraxane. 
V obdobju spremljanja zdravila Abraxane po začetku trženja so opazili paralizo kranialnih živcev, parezo glasilk in redke primere reakcij hude preobčutljivosti.
There was a statistically significant improvement in PFS for patients treated with Abraxane/gemcitabine versus gemcitabine alone, with 1.8 months increase in median PFS. 
Pri bolnikih, zdravljenih z zdravilom Abraxane/gemcitabinom, v primerjavi s tistimi, ki so se zdravili samo z gemcitabinom, se je preživetje brez napredovanja bolezni statistično značilno izboljšalo, mediano preživetje brez napredovanja bolezni se je podaljšalo za 1,8 meseca.
Reconstitution and administration of the product 
Rekonstitucija in dajanje zdravila
Using a sterile syringe, 50 ml of sodium chloride 9 mg/ml (0.9%) solution for infusion should slowly be injected into the 250 mg vial of Abraxane over a minimum of 1 minute. 
S sterilno brizgo počasi injicirajte 50 ml natrijevega klorida 9 mg/ml (0,9 %) raztopine za infundiranje v 250 mg vialo z zdravilom Abraxane najmanj 1 minuto.
Rare: Radiation recall phenomenon, radiation pneumonitis 
Redki: preobčutljivost predhodno obsevanih predelov, obsevalni pnevmonitis
Using a sterile syringe, 20 ml of sodium chloride 9 mg/ml (0.9%) solution for infusion should slowly be injected into the 100 mg vial of Abraxane over a minimum of 1 minute. 
S sterilno brizgo počasi injicirajte 20 ml natrijevega klorida 9 mg/ml (0,9 %) raztopine za infundiranje v 100 mg vialo z zdravilom Abraxane najmanj 1 minuto.
• Increased weight, increased lactate dehydrogenase in the blood, decreased kidney function, 
• zvečana telesna masa, povišana laktat dehidrogenaza v krvi, zmanjšana funkcija ledvic, povišan krvni sladkor, povišana vrednost fosforja v krvi
Overall Survival Number of deaths, n (%) Median OS (95% CI) (months) HRA/T (95.1% CI) 
Celokupno preživetje število smrti, n (%) mediana celokupnega preživetja (95 % IZ) (meseci)
A pharmacokinetic study was conducted with Abraxane and carboplatin in non-small cell lung cancer patients. 
Pri bolnikih z nedrobnoceličnim pljučnim rakom so opravili farmakokinetično študijo z zdravilom Abraxane in karboplatinom.
If Abraxane contacts mucous membranes, the membranes should be flushed thoroughly with water. 
Če zdravilo Abraxane pride v stik s sluznico, jo takoj temeljito sperite z vodo.
When Abraxane is used as monotherapy, if Grade 3 sensory neuropathy develops, treatment should be withheld until resolution to Grade 1 or 2 followed by a dose reduction for all subsequent courses of Abraxane is recommended (see section 4.2). 
Če se razvije senzorična nevropatija 3. stopnje, ko se zdravilo Abraxane uporablja kot monoterapija, je treba zdravljenje prekiniti, dokler se le-ta ne izboljša do 1. ali 2. stopnje.
Death or progression, n (%) Median PFS (95% CI) (months) HRA/T (95% CI) 
smrt ali napredovanje bolezni, n (%) mediana preživetja brez napredovanja bolezni (95 % IZ) (meseci)
250 mg vial: Using a sterile syringe, 50 ml of sodium chloride 9 mg/ml (0.9%) solution for infusion should slowly be injected into a vial of Abraxane over a minimum of 1 minute. 
Viala z 250 mg: S sterilno brizgo počasi injicirajte 50 ml natrijevega klorida 9 mg/ml (0,9 %) raztopine za infundiranje v vialo z zdravilom Abraxane najmanj 1 minuto.
For treatment of non-small cell lung cancer Abraxane is given once every week (i.e. on days 1, 8 and 15 of a 21 day cycle), with carboplatin being given once every three weeks (i.e. only on day 1 of each 21-day cycle), immediately after the Abraxane dose has been given. 
1., 8. in 15. dan 21-dnevnega cikla), skupaj s karboplatinom, ki se daje enkrat na tri tedne (t.j.
100 mg vial: Using a sterile syringe, 20 ml of sodium chloride 9 mg/ml (0.9%) solution for infusion should slowly be injected into a vial of Abraxane over a minimum of 1 minute. 
Viala s 100 mg: S sterilno brizgo počasi injicirajte 20 ml natrijevega klorida 9 mg/ml (0,9 %) raztopine za infundiranje v vialo z zdravilom Abraxane vsaj 1 minuto.
Administer Abraxane using an infusion set incorporating a 15 µm filter to avoid administration of these strands. 
Da se boste izognili dajanju teh vlaken, dajajte zdravilo Abraxane z infuzijskim sistemom, ki vključuje 15 µm filter.
Very common: Nausea, diarrhoea, vomiting, constipation, abdominal pain, abdominal pain upper 
Zelo pogosti: navzea, driska, bruhanje, zaprtost, bolečine v trebuhu, bolečina v zgornjem delu trebuha
Very common: Diarrhoea, vomiting, nausea, constipation 
Zelo pogosti: slabost, driska, bruhanje, zaprtost, stomatitis
• Irritated eyes, painful eyes, red eyes, itchy eyes, double vision, reduced vision, or seeing flashing lights, blurred vision due to swelling of the retina (cystoid macular oedema) 
• draženje oči, očesna bolečina, rdečina v očeh, srbenje oči, dvojni vid, poslabšanje vida,
Gemcitabine 
Dojenje
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.