FrancophonIA/ELRC3.0 huggingface dataset:
English: Kineret should be used with caution in patients with moderate renal impairment (CLcr 30 to 59 ml/min).
Slovenian: Pri bolnikih z zmerno ledvično okvaro (CLcr 30 do 59 ml/min) je treba zdravilo Kineret uporabljati previdno.
English: • the outer area of the upper arms
Slovenian: • zunanji del nadlakta
English: - Serious infections such as pneumonia (a chest infection) or infections of the skin can occur during Kineret treatment.
Slovenian: - Med zdravljenjem z zdravilom Kineret se lahko pojavijo resne okužbe, na primer pljučnica (okužba v prsnem košu) ali okužbe kože.
English: The incidence of serious infection was higher in Kineret-treated patients compared to patients receiving placebo (1.8% vs. 0.7%).
Slovenian: zdravljenih z zdravilom Kineret, kot pri bolnikih, ki so dobivali placebo (1,8 % proti 0,7 %).
English: Injection site reaction Uncommon (≥ 1/1,000 to < 1/100) Rash
Slovenian: reakcija na mestu injiciranja občasni (≥ 1/1.000 do < 1/100) izpuščaj preiskave zelo pogosti (≥ 1/10)
English: Symptoms of MAS can be e.g. persistent high fever, swelling of lymph nodes, and persistent rash.
Slovenian: Simptomi MAS so lahko npr. vztrajna zvišana telesna temperatura, otekle bezgavke in vztrajni izpuščaj.
English: Kineret is a sterile unpreserved solution.
Slovenian: Zdravilo Kineret je sterilna raztopina brez dodanih sredstev za konzerviranje.
English: During post-marketing use case reports of MAS in Kineret treated patients with Still's disease have been received.
Slovenian: Med uporabo po začetku trženja so pri bolnikih s Stillovo boleznijo, ki so se zdravili z zdravilom Kineret, poročali o primerih MAS.
English: In RA patients the most common and consistently reported treatment-related adverse reactions associated with Kineret were ISRs.
Slovenian: Najpogostejši neželeni učinki pri bolnikih z RA, ki so povezani z zdravljenjem in o katerih so pri zdravilu Kineret najdosledneje poročali, so bile reakcije na mestu injiciranja (ISR).
English: Mean (SD) estimates of clearance (CL/F) and volume of distribution (Vd/F) by population analysis of data from two PK studies in 35 RA patients were 105(27) ml/min and 18.5(11) l, respectively.
Slovenian: Srednji oceni (standardni odklon) očistka (CL/F) in volumna porazdelitve (Vd/F) s populacijsko analizo podatkov iz dveh farmakokinetičnih študij pri 35 bolnikih z
English: Each 0.67 ml graduated pre-filled syringe contains 100 mg of anakinra.
Slovenian: Ena 0,67 ml napolnjena odmerna injekcijska brizga vsebuje 100 mg anakinre.
English: Kineret was studied in a single randomized, blinded multi-center trial in 86 patients with polyarticular course JIA (ages 2-17 years) receiving a dose of 1 mg/kg subcutaneously daily, up to a maximum dose of 100 mg.
Slovenian: 86 bolnikov, ki so imeli JIA (v starosti od 2 do 17 let) s poliartikularnim potekom, in so prejemali dnevni odmerek 1 mg/kg subkutano do najvišjega odmerka 100 mg. 50 bolnikom, ki so dosegli klinični odziv po 12-tedenskem odprtem poteku, je bilo naključno razdeljeno zdravilo Kineret
English: Each graduated pre-filled syringe contains 100 mg of anakinra.
Slovenian: Ena odmerna napolnjena injekcijska brizga vsebuje 100 mg anakinre.
English: The patient reminder card shall contain the following key messages:
Slovenian: Opozorilna kartica za bolnika mora vključevati naslednje ključne elemente:
English: A causal relationship between Kineret and MAS has not been established.
Slovenian: Vzročna povezava med zdravilom Kineret in MAS ni bila ugotovljena.
English: - Swelling of the face, tongue or throat - Trouble swallowing or breathing - Suddenly feeling fast pulse or sweating - Itchy skin or rash
Slovenian: - resne alergijske reakcije, vključno z otekanjem obraza, jezika ali žrela, oteženo požiranje ali dihanje, nenaden pojav hitrega srčnega utripanja ali potenja in srbečica na koži ali izpuščaj,
English: Still's disease: Children weighing less than 50 kg are dosed by body weight with a starting dose of 1-2 mg/kg/day, patients weighing 50 kg or more are dosed with 100 mg/day.
Slovenian: Stillova bolezen: Otrokom s telesno maso manj kot 50 kg je treba prilagoditi odmerek glede na telesno maso, začetni odmerek pa je 1-2 mg/kg/dan.
English: Therefore the use of Kineret in patients with pre-existing malignancy is not recommended.
Slovenian: Učinek zdravljenja z zdravilom Kineret na že obstoječe malignome ni raziskan, zato zdravila Kineret ni priporočljivo uporabljati pri bolnikih z obstoječim malignomom.
English: B.
Slovenian: Slika B
English: Kineret is supplied ready for use in a graduated pre-filled syringe.
Slovenian: Zdravilo Kineret je na voljo v odmernih napolnjenih injekcijskih brizgah, pripravljenih za uporabo.
English: Still's Disease
Slovenian: Maligne bolezni
English: Hepatic impairment
Slovenian: Pljučni zapleti
English: Only clear, colourless-to-white solutions that may contain some product-related translucent-to-white amorphous particles should be injected.
Slovenian: Injicirati smete samo bistro, brezbarvno do belo raztopino, ki lahko vsebuje nekaj prosojnih do belih amorfnih delcev.
English: Put your thumb on the plunger rod and push slowly until the plunger front has reached the scale mark of your Kineret dose.
Slovenian: Položite palec na bat brizge in počasi potisnite navzdol,
English: Allergic reactions including anaphylactic reactions, angioedema, urticaria, rash, and pruritus have been reported uncommonly with Kineret.
Slovenian: Občasno so opazili alergijske reakcije na zdravilo Kineret, vključno z anafilaktičnimi reakcijami, angioedemom, urtikarijo, izpuščajem in srbenjem.
English: You should have no serious problems if you accidentally take more Kineret than you need.
Slovenian: Če si pomotoma vbrizgate več zdravila Kineret, kot je potrebno, ne bi smeli imeti resnih problemov.
English: Kineret 100 mg/0.67 ml solution for injection in pre-filled syringe.
Slovenian: Kineret 100 mg/0,67 ml raztopina za injiciranje v napolnjeni injekcijski brizgi
English: Kineret 100 mg/0.67 ml solution for injection in pre-filled syringe Anakinra
Slovenian: Kineret 100 mg/0,67 ml raztopina za injiciranje v napolnjeni injekcijski brizgi anakinra
English: MedDRA Organ System Frequency
Slovenian: Organski sistem
English: You must not breast-feed if you use Kineret.
Slovenian: Če uporabljate zdravilo Kineret, ne smete dojiti.
English: • The patient reminder card
Slovenian: • opozorilno kartico za bolnika.
English: Adverse reactions data in CAPS patients are based on an open-label study of 43 patients with NOMID/CINCA treated with Kineret for up to 5 years, with a total Kineret exposure of 159.8 patient years.
Slovenian: Neželeni učinki pri bolnikih s CAPS temeljijo na odprti študiji pri 43 bolnikih z NOMID/CINCA,
English: Citric acid, anhydrous Sodium chloride Disodium edetate dihydrate Polysorbate 80
Slovenian: FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi citronska kislina, brezvodna natrijev klorid dinatrijev edetat dihidrat polisorbat 80 natrijev hidroksid voda za injekcije
English: inflammation, and pain.
Slovenian: - oteženo požiranje ali dihanje
English: Very common (≥ 1/10)
Slovenian: neinfektivni hepatitis bolezni kože in podkožja zelo pogosti (≥ 1/10)
English: Common side effects (may affect up to 1 in 10 people): - Neutropenia (low white blood cell count) determined after a blood test.
Slovenian: - nevtropenija (nizko število belih krvnih celic), ugotovljena po preiskavi krvi.
English: No effects on embryo-foetal development in the rabbit were observed at doses 100 times the human dose.
Slovenian: Pri odmerkih, do 100-krat večjih od človeškega odmerka, niso opazili učinkov na razvoj zarodka in plodu pri kuncu.
English: SC
Slovenian: Slika C
English: • Keep used syringes out of reach and sight of children.
Slovenian: • Uporabljene injekcijske brizge shranjujte nedosegljive otrokom.
English: Before administration, visually inspect the solution for particulate matter and discolouration.
Slovenian: Pred uporabo morate raztopino pregledati, če vsebuje morebitne delce in/ali je obarvana.
English: Make sure you know what Kineret dose your doctor has prescribed; 20 to 90 mg, 100 mg or higher.
Slovenian: Poskrbite, da boste vedeli, kateri odmerek zdravila Kineret vam je predpisal zdravnik, od 20 do
English: Kineret treatment should not be initiated in patients with neutropenia (ANC < 1.5 x 109/l).
Slovenian: Pri bolnikih z nevtropenijo (ANC < 1,5 x 109/l) ne smemo uvesti zdravljenja z zdravilom Kineret.
English: In clinical trials, the crude incidence rate of malignancy was the same in the Kineret-treated patients and the placebo-treated patients and did not differ from that in the general population.
Slovenian: Kineret in placebo, enaka in se ni razlikovala od tiste v splošni populaciji.
English: Kineret treatment should be discontinued in RA patients if a serious infection develops.
Slovenian: Če se razvije resna okužba, je treba pri bolnikih z RA zdravljenje z zdravilom Kineret prekiniti.
English: Therefore, live vaccines should not be given concurrently with Kineret.
Slovenian: Med zdravljenjem z zdravilom Kineret se ne smete cepiti z živimi cepivi.
English: A study including 12 patients with hepatic dysfunction (Child-Pugh Class B) given a single 1mg/kg intravenous dose has been performed.
Slovenian: Jetrna okvara Izvedena je bila študija, v katero je bilo vključenih 12 bolnikov z jetrno disfunkcijo (razred Child
English: How to store Kineret
Slovenian: Shranjevanje zdravila Kineret
English: • a sterile gauze or tissue
Slovenian: - otekanje obraza, jezika ali žrela
English: Anakinra
Slovenian: Imunogenost
English: For Still´s disease, Kineret is used to treat the signs and symptoms of inflammation associated with the disease such as rash, joint pain and fever.
Slovenian: Za Stillovo bolezen se zdravilo Kineret uporablja za zdravljenje znakov in simptomov vnetja,
English: • Patient information leaflet
Slovenian: KLINIČNI PODATKI
English: EU/1/06/339/003 Preotact
Slovenian: EU/1/06/339/003
English: Subcutaneous powder: dual-chamber cartridge (glass) in pre-filled pen; solvent: dual-chamber cartridge (glass) in pre-filled pen
Slovenian: 100 µg prašek in vehikel za raztopino za injiciranje subkutana uporaba prašek: vložek z dvema komoroma (steklo) v napolnjenem injekcijskem peresniku vehikel: vložek z dvema komoroma v napolnjenem injekcijskem peresniku
English: Pack size
Slovenian: Preotact
English: 2 pre-filled pens
Slovenian: napolnjena injekcijska peresnika
English: Ref.: EMEA/264573/2009 EMEA/H/C/1019
Slovenian: EMEA/264573/2009 EMEA/H/C/1019
English: This authorisation was based on the authorisation granted to Avamys in January 2008 (‘informed consent').
Slovenian: Ta odobritev je temeljila na odobritvi dovoljenja za promet z zdravilom Avamys januarja 2008 (z „obveščenim soglasjem“).
English: The name of the medicine was changed to Alisade on 25 March 2009.
Slovenian: Ime zdravila je bilo 25. marca 2009 spremenjeno v Alisade.
English: Other information about Alisade:
Slovenian: Druge informacije o zdravilu Alisade:
English: fluticasone furoate EPAR summary for the public
Slovenian: flutikazon furoat Povzetek EPAR za javnost
English: The European Commission granted a marketing authorisation valid throughout the European Union for Fluticasone Furoate GSK to Glaxo Group Ltd on 6 October 2008.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Fluticasone Furoate GSK , veljavno po vsej Evropski uniji, odobrila družbi Glaxo Group Ltd. dne 6. oktobra 2008.
English: The effects of Alisade were first tested in experimental models before being studied in humans.
Slovenian: Učinki zdravila Alisade so bili najprej preskušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
English: However, it was not possible to determine if Alisade worked in children below the age of six years, because there were too few children below this age included the studies.
Slovenian: Ni pa bilo mogoče ugotoviti, ali je zdravilo Alisade delovalo tudi pri otrocih, starih manj kot šest let, ker je bilo v študije vključenih premalo otrok iz te starostne skupine.
English: The Committee recommended that Alisade be given marketing authorisation.
Slovenian: Odbor je priporočil, da se za zdravilo Alisade odobri dovoljenje za promet.
English: Previously known as Fluticasone Furoate GSK.
Slovenian: 1 Prej znano pod imenom Fluticasone Furoate GSK.
English: The most common side effect with Alisade (seen in more than 1 patient in 10) is epistaxis (nosebleeds).
Slovenian: Najpogostejši neželeni učinek zdravila Alisade (opažen pri več kot 1 bolniku izmed 10) je epistaksa (krvavitve iz nosu).
English: Alisade was compared with placebo (a dummy treatment) in six main studies involving almost 2,500 patients.
Slovenian: Zdravilo Alisade so primerjali s placebom (zdravilom brez zdravilne učinkovine) v šestih glavnih študijah, v katere je bilo vključenih skoraj 2 500 bolnikov.
English: What benefit has Alisade shown during the studies?
Slovenian: Kakšne koristi je zdravilo Alisade izkazalo med študijami?
English: This is generally mild or moderate and tends to affect adults who have used Alisade for more than six weeks.
Slovenian: Te so ponavadi blage do zmerne in so pogostejše pri odraslih, ki so uporabljali zdravilo Alisade več kot šest tednov.
English: What is the risk associated with Alisade?
Slovenian: Kakšna tveganja so povezana z zdravilom Alisade?
English: The first four studies looked at Alisade used in patients aged 12 years or over: three were short-term studies lasting two weeks and involved a total of 886 patients with seasonal allergic rhinitis (hay fever), while the fourth lasted four weeks and involved 302 patients with perennial (nonseasonal) allergies, such as allergies to animals.
Slovenian: Prve štiri študije so proučevale uporabo zdravila Alisade pri bolnikih, starih 12 let in več: tri študije so bile kratkotrajne, trajale so dva tedna in vključevale 886 bolnikov s sezonskim alergijskim rinitisom (senenim nahodom), medtem ko je četrta trajala štiri tedne in vključevala 302 bolnika s celoletnimi (nesezonskimi alergijami), kot so alergije na živali.
English: The active substance in Alisade, fluticasone furoate, is a corticosteroid.
Slovenian: Zdravilna učinkovina v zdravilu Alisade, flutikazon furoat, je kortikosteroid.
English: Alisade should only be used for as long as the patient is exposed to the allergen, such as pollen, house dust mites or other animals.
Slovenian: Zdravilo Alisade se lahko uporablja samo, dokler je bolnik izpostavljen alergenom, kot so cvetni prah, hišne pršice in druge živali.
English: The recommended dose of Alisade for patients aged 12 years and over is two sprays in each nostril once a day.
Slovenian: Priporočeni odmerek zdravila Alisade pri bolnikih, starih 12 let in več, je dva vpiha v vsako nosnico enkrat dnevno.
English: For the full list of all side effects reported with Alisade, see the Package Leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Alisade, glejte navodilo za uporabo.
English: Alisade should not be used in people who are allergic to fluticasone furoate or any of the other ingredients.
Slovenian: Zdravila Alisade ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) flutikazon furoat ali katero koli drugo sestavino zdravila.
English: In the study of perennial allergic rhinitis, Alisade had reduced scores by 3.6 points after four weeks, compared with a reduction of 2.8 points with placebo.
Slovenian: V študiji celoletnega alergijskega rinitisa je zdravilo Alisade po štirih tednih zmanjšalo vrednosti za 3,6 točke v primerjavi z zmanjšanjem za 2,8 točke pri placebu.
English: Why has Alisade been approved?
Slovenian: Zakaj je bilo zdravilo Alisade odobreno?
English: Alisade is used to treat the symptoms of allergic rhinitis.
Slovenian: Zdravilo Alisade se uporablja za zdravljenje simptomov alergijskega rinitisa.
English: The Committee for Medicinal Products for Human Use (CHMP) decided that Alisade's benefits are greater than its risks for the treatment of the symptoms of allergic rhinitis in patients aged six years or over.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Alisade pri zdravljenju simptomov alergijskega rinitisa pri bolnikih, starih šest let in več, večje od z njim povezanih tveganj.
English: In the studies of seasonal allergic rhinitis in patients aged 12 years or over, Alisade reduced symptom scores from around 9 points at the start of the study by between 3.6 and 5.4 points over two weeks, compared with a reduction of 2.3 to 3.7 points with placebo.
Slovenian: V študijah sezonskega alergijskega rinitisa pri bolnikih, starejših od 12 let, je zdravilo Alisade v dveh tednih za 3,6 do 5,4 točke zmanjšalo izhodiščno vrednost simptomov, ki je znašala približno 9 točk, v primerjavi z zmanjšanjem za 2,3 do 3,7 točke pri placebu.
English: Alisade is for use in patients aged six years and over.
Slovenian: Zdravilo Alisade se uporablja pri bolnikih, starih šest let in več.
English: The full EPAR for Alisade can be found here.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Alisade je na voljo tukaj.
English: Alisade is a nasal spray that contains the active substance fluticasone furoate.
Slovenian: Alisade je pršilo za nos, ki vsebuje zdravilno učinkovino flutikazon furoat.
English: How has Alisade been studied?
Slovenian: Kako je bilo zdravilo Alisade raziskano?
English: What is Alisade used for?
Slovenian: Za kaj se zdravilo Alisade uporablja?
English: Alisade was more effective than placebo at reducing symptoms of allergic rhinitis in patients aged six years and over.
Slovenian: Zdravilo Alisade je bilo pri zmanjševanju simptomov alergijskega rinitisa pri bolnikih, starih šest let in več, učinkovitejše od placeba.
English: How is Alisade used?
Slovenian: Kako se zdravilo Alisade uporablja?
English: What is Alisade?
Slovenian: Kaj je zdravilo Alisade?
English: How does Alisade work?
Slovenian: Kako zdravilo Alisade deluje?
English: There are no ongoing clinical trials or compassionate use programmes.
Slovenian: Trenutno ne potekajo nobena klinična preskušanja ali programi sočutne uporabe.
English: The company informed the CHMP that this withdrawal has no consequences for patients.
Slovenian: Družba je obvestila CHMP, da umik nima nobenih posledic za bolnike.
English: Two medicines are bioequivalent when they produce the same levels of the active substances in the body.
Slovenian: Dve zdravili sta biološko enakovredni, kadar dosegata enake ravni zdravilne učinkovine v telesu.
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that the medicine could not have been approved based on the data presented by the company.
Slovenian: Zato je CHMP v času umika menil, da na podlagi podatkov, ki jih je predstavila družba, zdravila ni mogoče odobriti.
English: Alendronic acid reduces the loss of bone tissue and colecalciferol, also known as vitamin D3, increases the absorption of calcium and formation of bone.
Slovenian: Alendronska kislina zmanjšuje izgubo kostnega tkiva, holekalciferol, znan tudi kot vitamin D3, pa povečuje absorpcijo kalcija in tvorbo kosti.
English: On 27 May 2016, Mylan SAS officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Alendronic Acid/Colecalciferol Mylan, for the treatment of postmenopausal osteoporosis in women at risk of vitamin D deficiency.
Slovenian: Družba Mylan SAS je dne 27. maja 2016 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za pridobitev dovoljenja za promet z zdravilom Alendronic Acid/Colecalciferol Mylan, namenjenim zdravljenju pomenopavzne osteoporoze pri ženskah, pri katerih obstaja tveganje za pomanjkanje vitamina D.
English: In its letter notifying the Agency of the withdrawal of application, the company stated that the time required to generate the supporting data makes this product unviable.
Slovenian: Družba je v dopisu, s katerim je Agencijo obvestila o umiku vloge, navedla, da je zdravilo zaradi časa, potrebnega za pridobitev podpornih podatkov, neizvedljivo.
English: The CHMP also considered that data from the study do not convincingly establish that Alendronic Acid/Colecalciferol Mylan is sufficiently similar to the reference medicine, Fosavance.
Slovenian: Odbor je prav tako menil, da podatki iz študije niso dovolj prepričljivi pri ugotavljanju, ali je zdravilo Alendronic Acid/Colecalciferol Mylan dovolj podobno referenčnemu zdravilu Fosavance.
English: Because Alendronic Acid/Colecalciferol Mylan is a generic medicine, the company had presented results of a study to determine that Alendronic Acid/Colecalciferol Mylan is bioequivalent to the reference medicine, Fosavance.
Slovenian: Ker je zdravilo Alendronic Acid/Colecalciferol Mylan generično zdravilo, je družba predložila rezultate študije za ugotavljanje, ali je zdravilo Alendronic Acid/Colecalciferol Mylan biološko enakovredno referenčnemu zdravilu Fosavance.
English: This means that Alendronic Acid/Colecalciferol Mylan was intended to be similar to a ‘reference medicine' already authorised in the European Union called Fosavance.
Slovenian: To pomeni, da naj bi bilo zdravilo Alendronic Acid/Colecalciferol Mylan podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji, in sicer zdravilu Fosavance.
English: Alendronic Acid/Colecalciferol Mylan is a medicine that contains two active substances: alendronic acid and colecalciferol.
Slovenian: Alendronic Acid/Colecalciferol Mylan je zdravilo, ki vsebuje dve zdravilni učinkovini: alendronsko kislino in holekalciferol.
English: Alendronic Acid/Colecalciferol Mylan was developed as a ‘generic medicine'.
Slovenian: Zdravilo Alendronic Acid/Colecalciferol Mylan je bilo razvito kot „generično zdravilo“.
English: Based on the review of the data, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Alendronic Acid/Colecalciferol Mylan could not have been approved for the treatment of postmenopausal osteoporosis in women at risk of vitamin D insufficiency.
Slovenian: Na podlagi pregleda podatkov je Odbor v času umika izrazil določene zadržke in je začasno menil, da zdravila Alendronic Acid/Colecalciferol Mylan ni mogoče odobriti za zdravljenje pomenopavzne osteoporoze pri ženskah, pri katerih obstaja tveganje za pomanjkanje vitamina D. Odbor je izrazil zadržke glede tega, kako je bila izvedena bioekvivalenčna študija.
English: Alendronic Acid/Colecalciferol Mylan was to be used to treat osteoporosis (a disease that makes bones fragile) in women who have been through the menopause and are at risk of insufficient vitamin-D levels.
Slovenian: Zdravilo Alendronic Acid/Colecalciferol Mylan naj bi se uporabljalo za zdravljenje osteoporoze (bolezni, ki povzroča krhkost kosti) pri ženskah v obdobju po menopavzi, pri katerih obstaja tveganje za pojav nezadostne ravni vitamina D. Zmanjševalo naj bi tveganje za zlome kosti v hrbtenici in kolkih.
English: What is Alendronic Acid/Colecalciferol Mylan?
Slovenian: Kaj je zdravilo Alendronic Acid/Colecalciferol Mylan?
English: Alendronic Acid/Colecalciferol Mylan is expected to work in the same way as the reference medicine, Fosavance.
Slovenian: Zdravilo Alendronic Acid/Colecalciferol Mylan naj bi delovalo na enak način kot referenčno zdravilo Fosavance.
English: How is Alendronic Acid/Colecalciferol Mylan expected to work?
Slovenian: Kako naj bi zdravilo Alendronic Acid/Colecalciferol Mylan delovalo?
English: What was Alendronic Acid/Colecalciferol Mylan expected to be used for?
Slovenian: Za kaj naj bi se zdravilo Alendronic Acid/Colecalciferol Mylan uporabljalo?
English: EMA/354096/2016
Slovenian: junij 2016
English: This meant that a thorough evaluation of potential risks with Adlumiz was not possible.
Slovenian: To pomeni, da temeljito ovrednotenje morebitnih tveganj z zdravilom Adlumiz ni bilo mogoče.
English: The CHMP refusal was confirmed after re-examination.
Slovenian: Zavrnitev odbora CHMP je bila po ponovni preučitvi potrjena.