FrancophonIA/ELRC3.0 huggingface dataset:
English: Administration of Skyrizi in the upper, outer arm may only be performed by a healthcare professional or caregiver.
Slovenian: V zunanji del nadlakti sme zdravilo Skyrizi injicirati le zdravstveni delavec ali bolnikov negovalec.
English: Includes: respiratory tract infection (viral, bacterial or unspecified), sinusitis (including acute), rhinitis, nasopharyngitis, pharyngitis (including viral), tonsillitis Includes: tinea pedis, tinea cruris, body tinea, tinea versicolor, tinea manuum, onychomycosis Includes: headache, tension headache, sinus headache Includes: fatigue, asthenia Includes: injection site bruising, erythema, haematoma, haemorrhage, irritation, pain, pruritus, reaction, swelling
Slovenian: Vključuje: okužbe dihal (virusne, bakterijske ali neopredeljene), sinuzitis (tudi akutni), rinitis, nazofaringitis, faringitis (tudi virusni), tonzilitis.
English: How to use Skyrizi
Slovenian: Kako uporabljati zdravilo Skyrizi
English: Check liquid
Slovenian: Preverite tekočino
English: Risankizumab is not expected to undergo metabolism by hepatic enzymes or renal elimination.
Slovenian: Ni pričakovati, da bi bil risankizumab podvržen presnovi z jetrnimi encimi ali izločanju skozi ledvice.
English: One pre-filled syringe contains 75 mg risankizumab.
Slovenian: Ena napolnjena injekcijska brizga vsebuje 75 mg risankizumaba.
English: • front of left thigh
Slovenian: • sprednji del levega stegna
English: Continued on Adalimumab (N=56) n (%)
Slovenian: Nadaljevanje adalimumaba (N = 56) n (%)
English: 150 mg (two 75 mg injections) 4 weeks after 1
Slovenian: 150 mg (dve 75-mg injekciji) Na 12 tednov z začetkom po 2. odmerku
English: Do not use this medicine if the liquid is cloudy or contains flakes or large particles.
Slovenian: Zdravila ne uporabite, če je tekočina motna, ali vsebuje kosme ali velike delce.
English: Skyrizi 75 mg solution for injection in pre-filled syringe
Slovenian: Skyrizi 75 mg raztopina za injiciranje v napolnjeni injekcijski brizgi
English: Skyrizi 75 mg injection risankizumab SC
Slovenian: Skyrizi 75 mg injekcija risankizumab s.c.
English: • <PASI 50 were switched to risankizumab
Slovenian: • < PASI 50 so prešli na risankizumab,
English: Talk to your doctor if you are not sure what to do.
Slovenian: Če ste negotovi kaj storiti, se posvetujte z zdravnikom.
English: Improvements were observed in psoriasis involving the scalp, the nails, and the palms and soles at week 16 and week 52 in subjects treated with risankizumab.
Slovenian: Pri preiskovancih, zdravljenih z risankizumabom, so v 16. in 52. tednu opažali izboljšanja psoriaze lasišča, nohtov ter dlani in stopal.
English: Skyrizi should not be used if the solution is cloudy or discoloured, or contains large particles.
Slovenian: Zdravila Skyrizi se ne sme uporabiti, če je raztopina motna, spremenjene barve ali vsebuje velike delce.
English: • front of right thigh
Slovenian: • sprednji del desnega stegna
English: What Skyrizi contains
Slovenian: Kaj vsebuje zdravilo Skyrizi
English: Follow the steps below each time you use Skyrizi
Slovenian: Pri vsaki uporabi zdravila Skyrizi sledite spodaj opisanim korakom.
English: LABEL
Slovenian: NALEPKA
English: The clearance of risankizumab was not significantly influenced by gender or race in adult subjects with plaque psoriasis.
Slovenian: Spol in rasa odraslih preiskovancev s psoriazo v plakih nista pomembno vplivala na očistek risankizumaba.
English: Water for injections
Slovenian: Predeli za injiciranje
English: You may have slight bleeding from where you injected.
Slovenian: Mesto, kamor ste injicirali, lahko rahlo zakrvavi.
English: Needle cover
Slovenian: Pokrovček igle
English: With dosing of 150 mg at week 0, week 4 and every 12 weeks thereafter, estimated steady-state peak and trough plasma concentrations are 12 and 2 µg/mL, respectively.
Slovenian: teden in nato vsakih 12 tednov sta bili ocenjena največja in najmanjša koncentracija v plazmi v stanju dinamičnega ravnovesja 12 µg/ml (največja) in 2 µg/ml (najmanjša).
English: How Skyrizi works
Slovenian: Kako deluje zdravilo Skyrizi
English: Week 16 200 (65.8) Week 52 229 (75.3) PSS 0 (symptom-free)
Slovenian: 16. teden 200 (65,8) 52. teden 229 (75,3)
English: Plunger rod Finger grip
Slovenian: Držalo za prste
English: Anti-TB therapy should be considered prior to initiating risankizumab in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed.
Slovenian: Pri bolnikih z anamnezo latentne ali aktivne TB, pri katerih ni mogoče potrditi, da so opravili ustrezen ciklus zdravljenja, je treba pred uvedbo risankizumaba razmisliti o protituberkuloznem zdravljenju.
English: Week 16 89 (29.3) Week 52 173 (56.9) All comparisons of risankizumab versus ustekinumab and placebo achieved p<0.001 except for PASI 75 at week 52 in ULTIMMA-2 where p=0.001
Slovenian: Vse primerjave risankizumaba z ustekinumabom in placebom so dosegle p < 0,001, razen za PASI 75 v 52. tednu študije ULTIMMA-2, kjer je bila vrednost p = 0,001.
English: Do not use Skyrizi
Slovenian: Ne uporabljajte zdravila Skyrizi
English: Each pre-filled syringe contains 75 mg risankizumab in 0.83 ml.
Slovenian: Ena napolnjena injekcijska brizga vsebuje 75 mg risankizumaba v 0,83 ml.
English: Tinea infections
Slovenian: Okužbe s tineo
English: Skyrizi 75 mg solution for injection in pre-filled syringe risankizumab
Slovenian: Skyrizi 75 mg raztopina za injiciranje v napolnjeni injekcijski brizgi risankizumab
English: No overall differences in risankizumab exposure were observed between older and younger subjects who received risankizumab.
Slovenian: Med starejšimi in mlajšimi preiskovanci, ki so prejemali risankizumab, na splošno niso opazili razlik v izpostavljenosti risankizumabu.
English: Each pre-filled syringe contains 75 mg of risankizumab in 0.83 ml solution.
Slovenian: Ena napolnjena injekcijska brizga vsebuje 75 mg risankizumaba v 0,83 ml raztopine.
English: Folliculitis
Slovenian: Folikulitis
English: Drug interactions
Slovenian: Medsebojno delovanje z zdravili
English: 150 mg (two 75 mg injections) When your doctor tells you nd dose
Slovenian: 1. odmerek 150 mg (dve 75-mg injekciji) Ko vam naroči zdravnik 2. odmerek 150 mg (dve 75-mg injekciji) 4 tedne po 1.odmerku Nadaljnji odmerki
English: List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, applicants / marketing authorisation holders in the Member States
Slovenian: Seznam imen, farmacevtskih oblik, jakosti zdravila, poti uporabe, predlagateljev, imetnikov dovoljenj za promet z zdravilom v državah članicah
English: This summary was last updated in April 2013.
Slovenian: Povzetek je bil nazadnje posodobljen dne 04-2013.
English: Other information about TruScient:
Slovenian: Druge informacije o zdravilu TruScient:
English: TruScient should only be used by a veterinarian.
Slovenian: Zdravilo TruScient lahko uporablja samo veterinar.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for TruScient on 14 December 2011.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom TruScient, veljavno po vsej Evropski uniji, odobrila dne 14. 12. 2011.
English: TruScient has been developed for use in dogs based on the approved use of the InductOs product in humans (EU/1/02/226/001).
Slovenian: Zdravilo TruScient je bilo razvito za uporabo pri psih na podlagi odobrene uporabe zdravila InductOs pri ljudeh (EU/1/02/226/001).
English: The main side effects with TruScient (seen in more than 1 dog in 10) were lameness, and firm and soft swelling during the first three weeks after surgery.
Slovenian: Glavni neželeni učinki zdravila TruScient (opaženi pri več kot 1 od 10 psov) so bili šepanje ter čvrste in mehke otekline v prvih treh tednih po operaciji.
English: The prepared collagen sponges are then cut, if needed, to the correct size before use.
Slovenian: Pripravljeni kolagenski gobici se nato po potrebi razrežeta, tako da sta pred uporabo ustrezne velikosti.
English: It must not be used in young dogs whose bones are not fully developed, have an active infection at the site of operation, pathological fracture (caused by a disease), or any active malignancy (cancerous growth).
Slovenian: Ne sme se uporabljati pri mladih psih, katerih kosti še niso povsem razvite, ter pri psih z aktivno okužbo na mestu operacije, s patološkimi zlomi (ki jih povzročajo bolezni) ali s katerim koli aktivnim malignim obolenjem (rakasta rast).
English: What benefit has TruScient shown during the studies?
Slovenian: Kakšne koristi je zdravilo TruScient izkazalo med študijami?
English: TruScient was investigated in one main field study in 126 dogs with fractures of the diaphysis.
Slovenian: Zdravilo TruScient je bilo raziskano v eni glavni terenski študiji pri 126 psih z diafiznimi zlomi.
English: Dibotermin alfa is produced by a method known as ‘recombinant DNA technology': it is made by cells that have received a gene (DNA) which makes them able to produce dibotermin alfa.
Slovenian: Dibotermin alfa se proizvaja z metodo, imenovano „tehnologija rekombinantne DNK“: tvorijo ga celice, ki so prejele gen (DNK), s katerim lahko tvorijo dibotermin alfa.
English: After 18 weeks, the fractures of all the dogs treated with TruScient together with standard surgical care (84) were seen to have healed, compared with 95% of the dogs treated with standard surgical care alone (40 out of 42).
Slovenian: Po 18 tednih so bili zlomi vseh psov, ki so jih zdravili z zdravilom TruScient skupaj s standardno kirurško oskrbo (84), vidno ozdravljeni, medtem ko je bilo pri psih, ki so jih zdravili samo s standardno kirurško oskrbo, takih primerov samo 95 % (40 od 42).
English: TruScient is available as a kit for implant.
Slovenian: Zdravilo TruScient je na voljo kot komplet za implantacijo.
English: The replacement dibotermin alfa acts in the same way as BMP-2 produced naturally by the body.
Slovenian: Nadomestni dibotermin alfa deluje na enak način kot BMP-2, ki ga naravno tvori telo.
English: It is a copy of a protein called ‘bone morphogenetic protein 2' (BMP-2), which is produced naturally by the body and helps with the formation of new bone tissue.
Slovenian: Učinkovina je kopija beljakovine, imenovane „protein za morfogenezo kosti 2“ (BMP-2), ki se naravno tvori v telesu in pomaga pri tvorjenju novega kostnega tkiva.
English: What is the risk associated with TruScient?
Slovenian: Kakšna tveganja so povezana z zdravilom TruScient?
English: TruScient is made up into a solution before use, applied to the collagen sponges and left for at least 15 minutes (but no more than two hours).
Slovenian: Zdravilo TruScient se pred uporabo pripravi v raztopino ter nanese na kolagenski gobici, nato je treba počakati najmanj 15 minut (vendar ne več kot dve uri).
English: Why has TruScient been approved?
Slovenian: Zakaj je bilo zdravilo TruScient odobreno?
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of TruScient exceed the risks for the treatment of diaphyseal bone fractures in dogs and recommended that TruScient be given a marketing authorisation.
Slovenian: Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je zaključil, da so koristi zdravila TruScient za zdravljenje diafiznih zlomov pri psih večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
English: The main measure of effectiveness was the time until the fracture was seen to have healed using an X-ray (time to radiographic fracture healing).
Slovenian: Glavno merilo učinkovitosti je bil čas, v katerem se je zlom zacelil, kar so ocenjevali z uporabo rentgena (čas do radiografsko potrjene zacelitve kosti).
English: TruScient must not be used in dogs that are hypersensitive (allergic) to dibotermin alfa or any of the other ingredients.
Slovenian: Zdravilo TruScient se ne sme uporabljati pri psih, ki so preobčutljivi za (alergični na) dibotermin alfa ali katero koli drugo sestavino zdravila.
English: TruScient is a medicine that contains the active substance dibotermin alfa.
Slovenian: TruScient je zdravilo, ki vsebuje zdravilno učinkovino dibotermin alfa.
English: The kit allows the user to make a solution containing the active substance (0.2 mg/ml) to be applied onto collagen sponges which are implanted during surgery.
Slovenian: Komplet uporabniku omogoča pripravo raztopine, ki vsebuje zdravilno učinkovino (0,2 mg/ml) za nanos na kolagensko gobico, ki se vstavi med operacijo.
English: The newly formed bone grows into the collagen sponge, which then dissolves away.
Slovenian: Novo nastala kost se zraste s kolagensko gobico, ki se nato razgradi.
English: Only the amount of prepared sponge needed to cover the affected area of the bone should be used.
Slovenian: Uporabite samo količino pripravljene gobice, ki bo prekrila prizadeti del kosti.
English: Time to radiographic fracture healing was less when the dogs were treated with TruScient together with standard surgical care.
Slovenian: Čas do radiografsko potrjene zacelitve kosti je bil krajši pri psih, zdravljenih z zdravilom TruScient skupaj s standardno kirurško oskrbo.
English: The prepared collagen sponges are implanted during surgery by placing them directly onto the bone fracture and leaving them in place when the surgical wound is stitched up.
Slovenian: Pripravljeni kolagenski gobici se vstavita med kirurškim posegom, tako da se namestita neposredno na zlom kosti in se tam pustita tudi po šivanju kirurške rane.
English: TruScient is used in combination with standard surgical care to treat diaphyseal bone fractures (affecting the diaphysis, the main section of long bone) in dogs.
Slovenian: Zdravilo TruScient se uporablja v kombinaciji s standardno kirurško oskrbo za zdravljenje diafiznih zlomov kosti (prizadenejo diafizo, glavni del dolge kosti) pri psih.
English: The benefit/risk balance may be found in the scientific discussion module of this EPAR.
Slovenian: Za oceno razmerja med tveganji in koristmi glejte znanstveno razpravo tega evropskega javnega poročila o oceni zdravila (EPAR).
English: When the collagen sponge is implanted into the bone fracture, dibotermin alfa stimulates the bone tissue around the sponge to make new bone.
Slovenian: Po namestitvi kolagenskih gobic na zlom kosti dibotermin alfa spodbuja kostno tkivo okoli gobice, da tvori novo kost.
English: The study assessed TruScient used together with standard surgical care, compared with standard surgical care alone.
Slovenian: V študiji so ocenjevali uporabo zdravila TruScient skupaj s standardno kirurško oskrbo v primerjavi s samostojno kirurško oskrbo.
English: For a full list of all side effects reported with TruScient, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila TruScient, glejte navodilo za uporabo.
English: What is TruScient used for?
Slovenian: Za kaj se zdravilo TruScient uporablja?
English: The active substance in TruScient, dibotermin alfa, acts on the bone structure.
Slovenian: Zdravilna učinkovina v zdravilu TruScient, dibotermin alfa, deluje na strukturo kosti.
English: How has TruScient been studied?
Slovenian: Kako je bilo zdravilo TruScient raziskano?
English: If TruScient is accidentally spilled onto the skin or eyes, it should be rinsed off immediately.
Slovenian: V primeru nenamernega razlitja zdravila TruScient na kožo ali v oči jih nemudoma sperite.
English: What is TruScient?
Slovenian: Kaj je zdravilo TruScient?
English: How does TruScient work?
Slovenian: Kako zdravilo TruScient deluje?
English: The Reference Member State was Finland and the Concerned Member States were Austria, Denmark, Germany and Sweden.
Slovenian: Referenčna država članica je bila Finska, zadevne države članice pa so bile Avstrija, Danska, Nemčija, in Švedska.
English: International Non-Proprietary Name (INN): Lansoprazole
Slovenian: Mednarodno nelastniško ime (INN): Lansoprazol
English: The final opinion was converted into a Decision by the European Commission on 15 September 2005.
Slovenian: Končno mnenje je bilo spremenjeno v odločbo Evropske komisije dne 15. septembra 2005.
English: The Rapporteur and Co-Rapporteur appointed were Sif Ormarsdottir/Tomas Salmonson, Gottfried Kreutz/Julia Dunne respectively.
Slovenian: Za poročevalca in soporočevalca so bili imenovani Sif Ormarsdottir/Tomas Salmonson, Gottfried Kreutz/Julia Dunne.
English: The arbitration procedure started on 20 January 2005.
Slovenian: Arbitražni postopek se je začel 20. januarja 2005.
English: The Concerned Member States have not been able to reach an agreement in respect of the Mutual Recognition of the Marketing Authorisation granted by the
Slovenian: Zadevne države članice niso mogle doseči soglasja v zvezi z medsebojnim priznavanjem dovoljenja za promet z zdravilom, ki ga je podelila referenčna država članica.
English: The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II, together with the Summary of Product Characteristics in Annex III.
Slovenian: Seznam zadevnih imen proizvodov je naveden v Dodatku I. Znanstveni zaključki so podani v Dodatku II, skupaj s Povzetkom glavnih značilnosti zdravila v Dodatku III.
English: A Mutual Recognition Procedure was started on 16 September 2004.
Slovenian: Postopek za medsebojno priznavanje se je začel 16. septembra 2004.
English: The Marketing Authorisation Holder provided written explanations on 13 April 2005.
Slovenian: Imetnik dovoljenja za promet z zdravilom je podal pisna pojasnila 13. aprila 2005.
English: Germany referred the reasons for disagreement to the EMEA on 15 December 2004.
Slovenian: Nemčija je 15. decembra 2004 Evropski agenciji za zdravila podala razloge za nesoglasje.
English: During its June 2005 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee, was of the opinion that the benefit/risk ratio is favourable for
Slovenian: Na sestanku v juniju 2005, je CHMP glede na vse predložene podatke ter znanstveno razpravo znotraj Odbora menil, da je razmerje med koristmi in tveganji za zdravilo Lansoprazol Hexal ugodno.
English: Lansoprazol HEXAL (lansoprazole) is a proton pump inhibitor that inhibits gastric acid secretion and is used for treatment of duodenal and gastric ulcer, reflux oesophagitis, gastro-oesophageal reflux disease, treatment and prophylaxis of NSAID-associated gastric and duodenal ulcers, Zollinger-Ellison syndrome, and in combination with appropriate antibacterial therapeutic regimens for the eradication of Helicobacter pylori and prevention of relapse of peptic ulcers in patients with H. pylori associated ulcers.
Slovenian: Lansoprazol Hexal (lansoprazol) je zaviralec protonske črpalke, ki zavira izločanje želodčne kisline in se uporablja za zdravljenje razjed dvanajstnika in želodca, refluksnega vnetja požiralnika, gastroezofagealne refluksne bolezni, zdravljenje in preprečevanje razjed želodca in dvanajstnika, povezanih z jemanjem nesteroidnih protivnetnih zdravil (NSAID), zdravljenje Zollinger-Ellisonovega sindroma in v kombinaciji z ustreznim protibakterijskim zdravljenjem za eradikacijo Helicobacter pylori ter preprečevanje ponovitve peptične razjede pri bolnikih z razjedami, povezanimi s H. pylori.
English: Significant differences in comparison to the reference product have been identified with regard to the indications' section of the SPCs.
Slovenian: V primerjavi z referenčnim zdravilom so bile ugotovljene znatne razlike v zvezi z razdelkom o indikacijah v Povzetku glavnih značilnosti zdravila.
English: A Marketing Authorisation for Lansoprazol HEXAL (15 mg and 30 mg) was previously granted to
Slovenian: Lansoprazol Hexal 15 mg in 30 mg
English: The SPC of the reference product in Germany does not contain the indications related to the concomitant use of NSAIDs and the treatment and prevention of gastric and duodenal ulceration caused by these compounds.
Slovenian: Povzetek glavnih značilnosti zdravila za referenčno zdravilo v Nemčiji ne vsebuje indikacij, povezanih s sočasno uporabo nesteroidnih protivnetnih zdravil (NSAID) ter zdravljenjem in preprečevanjem razjed dvanajstnika in želodca, ki jih povzročajo te snovi.
English: The indications related to the concomitant use of NSAIDs and the treatment and prevention of gastric and duodenal ulceration caused by these compounds were supported.
Slovenian: Podprl je indikacije, povezane s sočasno uporabo nesteroidnih protivnetnih zdravil (NSAID) in zdravljenjem ter preprečevanjem razjed želodca in dvanajstnika, ki jih povzročajo te snovi.
English: 15 September 2005 EMEA/CHMP/230471/2005
Slovenian: EMEA/CHMP/230471/2005 ODBOR ZA ZDRAVILA ZA UPORABO V HUMANI MEDICINI (CHMP) MNENJE V ZVEZI Z NAPOTITVIJO IZ ČLENA 29(2)1 ZA
English: Hexal AG in Finland on 7 November 2003.
Slovenian: Dovoljenje za promet z zdravilom Lansoprazol Hexal (15 mg in 30 mg) je bilo prvotno dodeljeno družbi Hexal AG iz Finske 7. novembra 2003.
English: LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT, ROUTE OF ADMINISTRATION, APPLICANT, MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES
Slovenian: PRILOGA I SEZNAM IMEN, FARMACEVTSKE OBLIKE, JAKOSTI ZDRAVILA, NAČINA UPORABE, PREDLAGATELJA, IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH
English: Content (concentration)
Slovenian: Način uporabe Vsebina (koncentracija)
English: The corresponding decision from the commission was issued on 12 May 2011.
Slovenian: Ustrezna odločba Komisije je bila izdana 12. maja 2011.
English: Overall, the following should be taken into account:
Slovenian: Ob upoštevanju naslednjega,
English: The Singaporean manufacturing plant was only used once and no longer considered as an alternative.
Slovenian: Proizvodni obrat v Singapurju je bil uporabljen samo enkrat in se ne šteje več kot nadomestna možnost.
English: The conditions affecting the marketing authorisations are set out in Annex IV of the opinion.
Slovenian: Pogoji, ki vplivajo na dovoljenja za promet z zdravili, so navedeni v Prilogi IV mnenja.
English: - The current minimum standards for critical process parameters and limits e.g. for terminal sterilisation should be reviewed and improved, in compliance with process capabilities and best practice.
Slovenian: - Trenutni minimalni standardi za kritične parametre in omejitve postopka, na primer za končno sterilizacijo, morajo biti pregledani in izboljšani v skladu z zmogljivostmi postopka in najboljšo prakso.
English: Consequently bioburden specifications of the filled containers should also be harmonised.
Slovenian: Posledično je treba uskladiti tudi specifikacije mikrobne obremenitve v napolnjenih vsebnikih.
English: The CHMP reviewed all the data available for each of the sites concerned.
Slovenian: CHMP je pregledal vse razpoložljive podatke za vsak zadevni proizvodni obrat.
English: The necessary data packages to support the inclusion of one more additional manufacturing site located in Europe (Poland) which is expected to become fully operational soon, was also expedited.
Slovenian: Potrebni podatkovni paketi v podporo vključitvi enega dodatnega proizvodnega obrata, ki se nahaja v Evropi (Poljska), ki naj bi kmalu postal popolnoma operativno sposoben, so bili prav tako pospešeni.
English: The sterilisation process should be re-validated using biological indicators as per Ph. Eur..
Slovenian: Postopek sterilizacije se mora ponovno validirati z uporabo bioloških indikatorjev, kot je navedeno v Evropski farmakopeji.
English: The coordinated review of the conditions by the CHMP will enable the appropriate harmonious adjustments with minimum impact on supply of PD solutions to the EU market.
Slovenian: Usklajen pregled pogojev CHMP bo omogočil ustrezne usklajene prilagoditve s kar najmanjšim vplivom na oskrbo tržišča EU z raztopinami za PD.
English: The present opinion is the second of a series of entwined opinions, which may result subsequently in additional measures being requested for the site subject of the current opinion.
Slovenian: Trenutno mnenje je drugo v vrsti prepletajočih se mnenj, zaradi katerih bodo posledično morda potrebni dodatni ukrepi, ki jih bodo morali izvesti v obratu, za katerega je izdano to mnenje.