FrancophonIA/ELRC3.0 huggingface dataset:
English: COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 29(2)1 REFERRAL FOR Doxazosin Retard “Arrow” 4 mg prolonged release tablets and associated names International Non-Proprietary Name (INN): Doxazosin
Slovenian: Doxazosin Retard “Arrow” 4 mg tablete s podaljšanim sproščanjem in povezana imena Mednarodno nelastniško ime (INN): Doxazosin
English: Actos pioglitazone
Slovenian: Actos pioglitazon
English: What measures are being taken to ensure the safe and effective use of Actos?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Actos?
English: Further studies also looked at long-term use of Actos.
Slovenian: V nadaljnjih študijah so proučevali tudi dolgoročno uporabo zdravila Actos.
English: Other information about Actos:
Slovenian: Druge informacije o zdravilu Actos:
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Actos on 13 October 2000.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Actos, veljavno po vsej Evropski uniji, izdala 13. oktobra 2000.
English: Almost 7,000 patients received Actos in all of the studies combined.
Slovenian: V vseh študijah skupaj je zdravilo Actos prejemalo skoraj 7 000 bolnikov.
English: The full EPAR for Actos can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Actos je na voljo na spletni strani agencije:ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Treatment with Actos should be reviewed after three to six months, and discontinued in patients who are not deriving sufficient benefit.
Slovenian: Zdravljenje z zdravilom Actos je treba ponovno oceniti po treh do šest mesecih in ga pri bolnikih, ki od njega nimajo zadostne koristi, ukiniti.
English: What benefit has Actos shown during the studies?
Slovenian: Kakšne koristi je zdravilo Actos izkazalo med študijami?
English: This is a summary of the European public assessment report (EPAR) for Actos.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Actos.
English: Actos is a medicine that contains the active substance pioglitazone.
Slovenian: Actos je zdravilo, ki vsebuje zdravilno učinkovino pioglitazon.
English: For more information about treatment with Actos, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Actos preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: The CHMP decided that Actos's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: Odbor CHMP je zaključil, da so koristi zdravila Actos večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
English: If Actos is used in combination with other diabetes medicines, other side effects may occur.
Slovenian: Če se zdravilo Actos uporablja v kombinaciji z drugimi zdravili za zdravljenje sladkorne bolezni, se lahko pojavijo še drugi neželeni učinki.
English: The company that markets Actos will produce educational material for doctors prescribing the medicine, which will cover the possible risk of heart failure and bladder cancer with treatments that contain pioglitazone, the criteria for selecting patients and the need to review treatment regularly and stop treatment if patients are no longer benefiting.
Slovenian: Družba, ki trži zdravilo Actos, bo zagotovila izobraževalno gradivo za zdravnike, ki bodo predpisovali zdravilo, in bo vključevalo možno tveganje za srčno popuščanje ter rak sečnega mehurja pri zdravljenju s pioglitazonom, merila za izbiro bolnikov in potrebo po redni oceni zdravljenja ter prekinitvi zdravljenja, če bolnikom ne koristi več.
English: Actos is used to treat type 2 diabetes in adults (aged 18 years or over), particularly those who are overweight.
Slovenian: Zdravilo Actos se uporablja za zdravljenje sladkorne bolezni tipa 2 pri odraslih (starejših od 18 let), zlasti tistih s prekomerno telesno maso.
English: The most common side effects with Actos (seen in between 1 and 10 patients in 100) are upper respiratory tract infection (colds), hypoaesthesia (reduced sense of touch), visual disturbance, bone fractures and increased weight.
Slovenian: Najpogostejši neželeni učinki zdravila Actos (opaženi pri 1 do 10 bolnikih od 100) so okužba zgornjih dihal (prehladi), hipestezija (zmanjšan občutek za dotik), motnje vida, zlomi kosti in povečanje telesne mase.
English: It must also not be used in patients who have or have had bladder cancer or those with blood in the urine that has not yet been investigated.
Slovenian: Poleg tega ga ne smejo uporabljati bolniki, ki imajo ali so imeli rak sečnega mehurja, ali bolniki, ki imajo kri v urinu, vendar preiskave v zvezi s tem še niso bile opravljene.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Actos.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: Actos must not be used in patients who have problems with their liver, patients who have had heart failure (when the heart does not work as well as it should) or patients with diabetic ketoacidosis (a complication of diabetes).
Slovenian: Zdravila ne smejo uporabljati bolniki, ki imajo težave z jetri, bolniki s srčnim popuščanjem (pri katerih srce ne deluje, kot bi moralo) ali bolniki z diabetično ketoacidozo (zapletom pri sladkorni bolezni).
English: The active substance in Actos, pioglitazone, makes cells (fat, muscle and liver) more sensitive to insulin, which means that the body makes better use of the insulin it produces.
Slovenian: Zdravilna učinkovina zdravila Actos, pioglitazon, poveča občutljivost celic (maščevja, mišic in jeter) za insulin, kar pomeni, da telo bolje izrablja insulin, ki ga proizvaja.
English: What is the risk associated with Actos?
Slovenian: Kakšna tveganja so povezana z zdravilom Actos?
English: Actos led to a decrease in the level of HbA1c, indicating that blood glucose levels had been reduced at doses of 15, 30 and 45 mg. Actos on its own was shown to be as effective as metformin and gliclazide.
Slovenian: Zdravilo Actos je znižalo ravni HbA1c, kar pomeni, da se je raven glukoze v krvi znižala pri odmerkih 15 mg, 30 mg in 45 mg. Kot samostojno zdravilo se je izkazalo za enako učinkovito kot metformin in gliklazid.
English: Why has Actos been approved?
Slovenian: Zakaj je bilo zdravilo Actos odobreno?
English: The studies measured the level of a substance in the blood called glycosylated haemoglobin (HbA1c), which gives an indication of how well the blood glucose is controlled.
Slovenian: V študijah so merili raven snovi v krvi, imenovane glikozilirani hemoglobin (HbA1c), ki kaže, kako dobro je raven glukoze v krvi uravnavana.
English: This dose may need to be increased after one or two weeks to up to 45 mg once a day if better blood glucose (sugar) control is needed.
Slovenian: Priporočeni začetni odmerek zdravila Actos je 15 ali 30 mg enkrat na dan. Odmerek bo po enem ali dveh tednih morda treba povečati na 45 mg enkrat na dan, če je potrebno boljše uravnavanje glukoze (sladkorja) v krvi.
English: Some studies also looked at combining Actos with a sulphonylurea, insulin or metformin, or with the combination of metformin and a sulphonylurea.
Slovenian: V nekaterih študijah so proučevali tudi kombiniranje zdravila Actos s sulfonilsečnino, insulinom ali metforminom ali s kombinacijo metformina in sulfonilsečnine.
English: Actos also improved the glucose control obtained in type 2 diabetes when it was added to existing treatment with a sulphonylurea, insulin or metformin, or the combination of metformin and a sulphonylurea.
Slovenian: Z zdravilom Actos je bila tudi bolje nadzorovana glukoza pri sladkorni bolezni tipa 2, če se je dodalo obstoječemu zdravljenju s sulfonilsečnino, insulinom ali metforminom ali kombinaciji metformina in sulfonilsečnine.
English: • on its own in patients for whom metformin (another diabetes medicine) is not suitable;
Slovenian: • kot samostojno zdravilo pri bolnikih, za katere metformin (drugo zdravilo za zdravljenje sladkorne bolezni) ni primerno;
English: For the full list of all side effects reported with Actos, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Actos, glejte navodilo za uporabo.
English: • together with insulin in patients who are not satisfactorily controlled with insulin alone and cannot take metformin.
Slovenian: • skupaj z insulinom pri bolnikih, pri katerih bolezen ni zadostno nadzorovana zgolj z insulinom in za katere metformin ni primeren.
English: • in combination with metformin in patients who are not satisfactorily controlled on metformin alone, or with a sulphonylurea (another type of diabetes medicine) when metformin is not suitable in patients who are not satisfactorily controlled on a sulphonylurea alone;
Slovenian: • v kombinaciji z metforminom pri bolnikih, pri katerih zgolj z metforminom ni mogoče doseči zadovoljivega uravnavanj, ali s sulfonilsečnino (drugo vrsto zdravila za zdravljenje sladkorne bolezni), če metformin ni primeren, pri bolnikih, pri katerih zgolj s sulfonilsečnino ni mogoče doseči zadovoljivega uravnavanja;
English: How has Actos been studied?
Slovenian: Kako je bilo zdravilo Actos raziskano?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Actos have also been included in the summary of product characteristics and the package leaflet.
Slovenian: V povzetek glavnih značilnosti zdravila in navodilo za uporabo so bili vključeni priporočila in previdnostni ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki za varno in učinkovito uporabo zdravila Actos.
English: Actos has been compared with placebo (a dummy treatment), metformin and gliclazide (a sulphonylurea) in a number of studies.
Slovenian: Zdravilo Actos so v številnih študijah primerjali s placebom (zdravilom brez zdravilne učinkovine), metforminom in gliklazidom (sulfonilsečnino).
English: How does Actos work?
Slovenian: Kako zdravilo Actos deluje?
English: What is Actos used for?
Slovenian: Za kaj se zdravilo Actos uporablja?
English: How is Actos used?
Slovenian: Kako se zdravilo Actos uporablja?
English: What is Actos?
Slovenian: Kaj je zdravilo Actos?
English: are continuously monitored.
Slovenian: stalno spremljajo.
English: and why it is authorised in the EU
Slovenian: in zakaj je odobreno v EU
English: authorised in the EU?
Slovenian: odobreno v EU?
English: The recommended dose is one tablet once a day, preferably taken with food.
Slovenian: Priporočeni odmerek je ena tableta na dan, ki se po možnosti vzame s hrano.
English: In addition, it may be used in adolescents who are resistant to first-line treatments or who cannot take them because of side effects.
Slovenian: Poleg tega se lahko uporablja tudi pri mladostnikih, ki so odporni proti zdravilom prve izbire ali teh zaradi neželenih učinkov ne morejo jemati.
English: is available as tablets (200 mg emtricitabine and 245 mg tenofovir disoproxil).
Slovenian: je na voljo v obliki tablet (200 mg emtricitabina in 245 mg dizoproksiltenofovirata).
English: Two medicines are bioequivalent when they produce the same levels of the active substances in the body and are therefore expected to have the same effect.
Slovenian: Dve zdravili sta biološko enakovredni, kadar dosegata enake ravni učinkovine v telesu in imata zato po pričakovanjih enak učinek.
English: is an HIV medicine that is used in combination with at least one other HIV medicine to treat adults infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Slovenian: je zdravilo proti virusu HIV, ki se uporablja v kombinaciji z vsaj enim drugim tovrstnim zdravilom za zdravljenje odraslih, okuženih z virusom humane imunske pomanjkljivosti tipa 1 (HIV-1), tj. virusom, ki povzroča sindrom pridobljene imunske pomanjkljivosti (aids).
English: does not cure HIV infection or AIDS, but it holds off the damage to the immune system and the development of infections and diseases associated with AIDS.
Slovenian: ne zdravi okužbe z virusom HIV ali aidsa, lahko pa upočasni slabšanje imunskega sistema ter razvoj okužb in bolezni, povezanih z aidsom.
English: can only be obtained with a prescription and treatment should be started by a doctor who has experience in the management of HIV infection.
Slovenian: je le na recept, zdravljenje z njim pa mora uvesti zdravnik, ki ima izkušnje z zdravljenjem okužbe z virusom HIV.
English: (emtricitabine / tenofovir disoproxil)
Slovenian: (emtricitabin/dizoproksiltenofovirat)
English: The company also carried out a study that showed that it is ‘bioequivalent' to the reference medicine.
Slovenian: Izvedla je tudi študijo, ki je pokazala, da je zdravilo biološko enakovredno referenčnemu zdravilu.
English: If patients need to stop taking emtricitabine or tenofovir, or need to take different doses, they will need to take medicines containing emtricitabine or tenofovir disoproxil separately.
Slovenian: Če bi morali bolniki prekiniti jemanje emtricitabina ali tenofovirja oziroma bi bilo treba njune odmerke spremeniti, morajo preiti na zdravila, ki ločeno vsebujejo emtricitabin ali dizoproksiltenofovirat.
English: Studies on the benefits and risks of the active substances in the authorised use have already been carried out with the reference medicine, Truvada, and do not need to be repeated for Emtricitabine/Tenofovir disoproxil Krka d.d.
Slovenian: Študije o koristih in tveganjih obeh učinkovin pri odobrenem načinu uporabe so že bile izvedene z referenčnim zdravilom Truvada, zato jih ni treba ponoviti za zdravilo Emtricitabin/dizoproksiltenofovirat Krka d.d.
English: contains two active substances: emtricitabine, which is a nucleoside reverse transcriptase inhibitor; and tenofovir disoproxil, which is a ‘prodrug' of tenofovir.
Slovenian: vsebuje dve učinkovini: emtricitabin, ki je nukleozidni zaviralec reverzne transkriptaze, in dizoproksiltenofovirat, ki je „predzdravilo“ tenofovirja.
English: Side effects reported with Emtricitabine/Tenofovir disoproxil Krka are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Emtricitabin/dizoproksiltenofovirat Krka d.d, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
English: The European Medicines Agency concluded that, in accordance with EU requirements, Emtricitabine/Tenofovir disoproxil Krka d.d.
Slovenian: Evropska agencija za zdravila je zaključila, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Emtricitabin/dizoproksiltenofovirat Krka d.d.
English: For more informationabout using Emtricitabine/Tenofovir disoproxil Krka d.d., see the package leaflet or contact your doctor or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila Emtricitabin/dizoproksiltenofovirat Krka d.d glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
English: can be found on the Agency's website: ema.europa.eu/en/medicines/human/EPAR/emtricitabinetenofovir-disoproxil-krka-dd. Information on the reference medicine can also be found on the Agency's website.
Slovenian: Nadaljnje informacije o zdravilu Emtricitabin/dizoproksiltenofovirat Krka d.d so na voljo na spletni strani agencije: ema.europa.eu/en/medicines/human/EPAR/emtricitabinetenofovir-disoproxil-krka-dd.
English: What measures are being taken to ensure the safe and effective use of Emtricitabine/Tenofovir disoproxil Krka d.d.
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Emtricitabin/dizoproksiltenofovirat Krka d.d.
English: As for every medicine, the company provided studies on the quality of Emtricitabine/Tenofovir disoproxil Krka d.d.
Slovenian: Tako kot za vsako zdravilo, je družba predložila študije o kakovosti zdravila Emtricitabin/dizoproksiltenofovirat Krka d.d.
English: Emtricitabine/Tenofovir disoproxil Krka d.d., taken in combination with at least one other antiviral medicine, reduces the amount of HIV in the blood and keeps it at a low level.
Slovenian: v kombinaciji z vsaj enim zdravilom proti okužbi z virusom HIV zniža količino virusa HIV v krvi in jo zadržuje na nizki ravni.
English: What are the benefits and risks of Emtricitabine/Tenofovir disoproxil Krka d.d.
Slovenian: Kakšne so koristi in tveganja, povezani z zdravilom Emtricitabin/dizoproksiltenofovirat Krka d.d.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Emtricitabine/Tenofovir disoproxil Krka d.d.
Slovenian: Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Emtricitabin/dizoproksiltenofovirat Krka d.d.
English: has been shown to have comparable quality and to be bioequivalent to Truvada.
Slovenian: primerljivo raven kakovosti kot referenčno zdravilo Truvada ter da mu je biološko enakovredno.
English: have also been included in the summary of product characteristics and the package leaflet.
Slovenian: upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
English: As for all medicines, data on the use of Emtricitabine/Tenofovir disoproxil Krka d.d.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Emtricitabin/dizoproksiltenofovirat Krka d.d.
English: Other information about Emtricitabine/Tenofovir disoproxil Krka d.d.
Slovenian: Druge informacije o zdravilu Emtricitabin/dizoproksiltenofovirat Krka d.d.
English: will provide an information pack to doctors which covers the potential harmful effects of Emtricitabine/Tenofovir disoproxil Krka d.d.
Slovenian: Družba, ki trži zdravilo Emtricitabin/dizoproksiltenofovirat Krka d.d., bo pripravila informativno gradivo za zdravnike, ki bo obsegalo opis možnih škodljivih učinkov tega zdravila na delovanje ledvic pri odraslih in otrocih.
English: The European Commission granted a marketing authorisation valid throughout the EU for Emtricitabine/Tenofovir disoproxil Krka d.d.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Emtricitabin/dizoproksiltenofovirat Krka d.d., veljavno po vsej EU, izdala 28. aprila 2017.
English: Why is Emtricitabine/Tenofovir disoproxil Krka d.d.
Slovenian: Zakaj je bilo zdravilo Emtricitabin/dizoproksiltenofovirat Krka d.d.
English: Because Emtricitabine/Tenofovir disoproxil Krka d.d.
Slovenian: Ker je zdravilo Emtricitabin/dizoproksiltenofovirat Krka d.d.
English: Emtricitabine/Tenofovir disoproxil Krka d.d contains two active substances, emtricitabine and tenofovir disoproxil.
Slovenian: vsebuje dve učinkovini, emtricitabin in dizoproksiltenofovirat.
English: An overview of Emtricitabine/Tenofovir disoproxil Krka d.d.
Slovenian: Pregled zdravila Emtricitabin/dizoproksiltenofovirat Krka d.d.
English: What is Emtricitabine/Tenofovir disoproxil Krka d.d.
Slovenian: Kaj je zdravilo Emtricitabin/dizoproksiltenofovirat Krka d.d.
English: Emtricitabine/Tenofovir disoproxil Krka d.d.
Slovenian: Zdravilo Emtricitabin/dizoproksiltenofovirat Krka d.d.
English: How is Emtricitabine/Tenofovir disoproxil Krka d.d.
Slovenian: Kako je bilo zdravilo Emtricitabin/dizoproksiltenofovirat Krka d.d.
English: How has Emtricitabine/Tenofovir disoproxil Krka d.d.
Slovenian: Kako se zdravilo Emtricitabin/dizoproksiltenofovirat Krka d.d.
English: The procedure started on 19 July 2007.
Slovenian: Postopek se je začel dne 19. julija 2007.
English: Ref. EMEA/CHMP/384874/2008
Slovenian: EMEA/CHMP/554251/2008
English: A Decision was issued by the European Commission on 7 October 2008.
Slovenian: Odločbo je Evropska komisija izdala 7. oktobra 2008.
English: London, 7 October 2008 Doc.
Slovenian: London, 7. oktober 2008 Sklic na dok.
English: The Marketing Authorisation Holder provided supplementary information on 23 November 2007 and 22 April 2008.
Slovenian: Imetnik dovoljenja za promet je dne 23. novembra 2007 in 22. aprila 2008 priskrbel dodatne informacije.
English: It is available as immediate release film coated tablets, modified release film coated tablets, granules and solutions for oral suspension, solutions for infusion in bags, solutions for infusion in bottles and sachets.
Slovenian: Na voljo je v obliki filmsko obloženih tablet s takojšnjim sproščanjem, filmsko obloženih tablet s prirejenim sproščanjem, zrnc in raztopin za peroralno suspenzijo, raztopin za infundiranje v vrečkah ter raztopin za infundiranje v stekleničkah in vrečkah.
English: Ciprofloxacin Bayer and associated names is an antibiotic, indicated for the treatment of uncomplicated and complicated infections, including severe infections, caused by ciprofloxacin susceptible pathogens.
Slovenian: Zdravilo Ciprofloxacin Bayer in povezana imena je antibiotik, namenjen zdravljenju nezapletenih in zapletenih okužb, vključno hudih okužb, ki jih povzročajo na ciprofloksacin občutljivi patogeni.
English: On 22 June 2007, France presented to the EMEA a referral under Article 30 of Directive 2001/83/EC, as amended, in order to harmonise the nationally authorised Summaries of Product Characteristics (SPC), Labelling and Package Leaflet of the medicinal product Ciprofloxacin Bayer and associated names.
Slovenian: Francija je dne 22. junija 2007 agenciji EMEA predložila napotitev v skladu s členom 30 Direktive 2001/83/ES, kakor je bila spremenjena, za uskladitev na nacionalni ravni odobrenih povzetkov glavnih značilnosti zdravila (SPC), označevanj in navodil za uporabo zdravila Cyprofloxacin Bayer in povezanih imen.
English: The basis for referral was that there were divergences in the Summaries of Product Characteristics (SPC) of Ciprofloxacin Bayer and associated names approved across EU Member States, with respect to the indications, the posology, the contra-indications and the special warnings and precautions for use.
Slovenian: Podlaga za napotitev so bila razhajanja med povzetki glavnih značilnosti zdravila (SPC) Ciprofloxacin Bayer in povezanih imen, ki so bili odobreni v državah članicah EU, zlasti v zvezi z indikacijami, odmerjanjem, kontraindikacijami ter posebnimi opozorili in previdnostnimi ukrepi.
English: COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 30 REFERRAL FOR Ciprofloxacin Bayer and associated names International Non-Proprietary Name (INN): ciprofloxacin
Slovenian: ODBOR ZA ZDRAVILA ZA UPORABO V HUMANI MEDICINI (CHMP) MNENJE V ZVEZI Z NAPOTITVIJO V SKLADU S ČLENOM 30 ZA zdravilo Ciprofloxacin Bayer in povezana imena Mednarodno nelastniško ime (INN): ciprofloksacin
English: During its July 2008 meeting, the CHMP, in the light of the overall submitted data and the scientific discussion within the Committee, was of the opinion that the proposal for the harmonisation of the SPC, Labelling and Package Leaflet was acceptable and that they should be amended.
Slovenian: Med svojim zasedanjem julija 2008 je CHMP na osnovi vseh predloženih podatkov in znanstvene razprave v Odboru menil, da je predlog za uskladitev povzetkov glavnih značilnosti zdravila, označevanj in navodil za uporabo sprejemljiv in da bi bilo treba navedene dokumente dopolniti.
English: The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II together with the amended SPC, Labelling and Package Leaflet in Annex III.
Slovenian: Seznam zadevnih imen zdravil je naveden v Dodatku I. Znanstveni zaključki so na voljo v Dodatku II, dopolnjeni povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo pa v Dodatku III.