FrancophonIA/ELRC3.0 huggingface dataset:
English: NAME OF THE MEDICINAL PRODUCT Spectrila 10,000 U powder for concentrate for solution for infusion Asparaginase
Slovenian: IME ZDRAVILA Spectrila 10.000 e. prašek za koncentrat za raztopino za infundiranje
English: Spectrila 10,000 U powder for concentrate for solution for infusion Asparaginase
Slovenian: Spectrila 10.000 e. prašek za koncentrat za raztopino za infundiranje asparaginaza
English: Blood clotting disorders may require you to receive fresh plasma or a certain type of protein (antithrombin III) in order to reduce the risk of bleeding or formation of blood clots (thrombosis).
Slovenian: (antitrombin III), da se bo zmanjšalo tveganje krvavitve ali nastanka krvnih strdkov (tromboza).
English: Disseminated intravascular coagulation (DIC), anaemia, leukopenia, thrombocytopenia
Slovenian: fibrinogena in D-dimera), amilaze, lipaze, trigliceridov in holesterola.
English: • allergic reactions including serious allergic reaction (anaphylactic shock), flushing, rash, low blood pressure, swelling of face and throat, hives, shortness of breath,
Slovenian: izpuščaj, nizek krvni tlak, otekanje obraza in žrela, koprivnico, kratko sapo,
English: Hypoalbuminaemia
Slovenian: Hipoalbuminemija
English: Due to the inhibition of protein synthesis (decreased synthesis of factors II, V, VII, VIII, and IX, proteins C and S, antithrombin III [AT III]) caused by asparaginase, coagulation disorders can occur which can manifest either as thrombosis, disseminated intravascular coagulation (DIC), or bleeding.
Slovenian: in S, antitrombina III [AT III]), ki jo povzroči asparaginaza, se lahko pojavijo motnje koagulacije, ki se pokažejo kot tromboza, diseminirana intravaskularna koagulacija (DIK) ali krvavitev.
English: Dyslipidemia
Slovenian: Bolezni živčevja
English: PHARMACEUTICAL FORM Powder for concentrate for solution for infusion.
Slovenian: FARMACEVTSKA OBLIKA prašek za koncentrat za raztopino za infundiranje bel prašek
English: Not evaluable / not known
Slovenian: MRD pozitivna ni mogoče oceniti/ni znano razlika (95 % CI
English: How to store Spectrila
Slovenian: Shranjevanje zdravila Spectrila
English: After administration of any asparaginase preparation, close monitoring of bilirubin, hepatic transaminases, blood/urinary glucose, coagulation parameters (e.g. PTT, PT, antithrombin III, fibrinogen and D-dimer), amylase, lipase, triglycerides and cholesterol is recommended.
Slovenian: Po dajanju katerega koli zdravila z asparaginazo je priporočljivo skrbno spremljanje bilirubina, jetrnih transaminaz, glukoze v krvi/urinu, koagulacijskih parametrov (npr. PTČ, PČ, antitrombina III,
English: • feeling sick (nausea), being sick (vomiting), stomach ache or watery stools (diarrhoea)
Slovenian: • slabost s siljenjem na bruhanje (navzea), bruhanje, bolečine v trebuhu ali redko blato (driska),
English: A method other than oral contraceptives should be used in women of childbearing potential (see section 4.4).Men should use effective contraceptive measures and be advised to not father a child while receiving asparaginase.
Slovenian: Moški morajo uporabljati učinkovite kontracepcijske ukrepe in jim je treba svetovati, naj ne spočnejo otroka, ko prejemajo asparaginazo.
English: Common side effects (may affect up to 1 in 10 people):
Slovenian: Pogosti neželeni učinki (lahko se pojavijo pri največ 1 od 10 bolnikov):
English: 6.1 List of excipients
Slovenian: FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi saharoza
English: Antineoplastic agents
Slovenian: Aktivnost asparaginaze
English: Spectrila
Slovenian: Zdravilo Spectrila
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 10,000 units of asparaginase.
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena viala vsebuje 10.000 enot asparaginaze.
English: The calculated quantity of asparaginase is dissolved further in 50 to 250 ml of sodium chloride 9 mg/ml (0.9 %) solution for injection.
Slovenian: Izračunano količino asparaginaze še nadalje raztopite v 50 do 250 ml raztopine natrijevega klorida
English: Reference asparaginase
Slovenian: Referenčna asparaginaza
English: medac GmbH Theaterstr.
Slovenian: Theaterstr.
English: • anaphylaxis,
Slovenian: • anafilaksija,
English: For EpiPen/Nepipe and associated names
Slovenian: Za EpiPen/Nepipe in povezana imena
English: Sometimes a single dose of adrenaline may not be sufficient to completely reverse the effects of a serious allergic reaction.
Slovenian: Včasih en odmerek adrenalina ne zadostuje za popolno odpravo znakov in simptomov resne alergijske reakcije.
English: The product information may be subsequently updated by the Member State competent authorities, in liaison with the Reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Slovenian: Pristojni organi držav članic bodo kasneje, v povezavi z referenčno državo članico, posodobili Informacije o zdravilu, kot je primerno, v skladu s postopki, ki jih določa Poglavje 4, Naslov III Direktive 2001/83/ES.
English: Section 6 - Contents of the pack and other information
Slovenian: Poglavje 6 - Vsebina pakiranja in dodatne informacije
English: All patients who are prescribed [Invented name] should be thoroughly instructed to understand the indications for the use and the correct method of administration (see section 6.6).
Slovenian: Vsem bolnikom, ki se jim predpiše zdravilo [ime zdravila], je treba podati podrobne informacije in poskrbeti, da razumejo indikacije za uporabo in pravilen način uporabe zdravila (glejte poglavje 6.6).
English: If your symptoms have not improved or have deteriorated within 5-15 minutes after the first injection, either you or the person with you should give a second injection.
Slovenian: Če se vaši simptomi v 5-15 minutah po prvi injekciji ne izboljšajo ali pa se poslabšajo, si morate sami ali pa vam mora nekdo drug injicirati še en odmerek zdravila [ime zdravila].
English: In the absence of clinical improvement or if deterioration occurs, a second injection with an additional [Invented name] may be administered 5-15 minutes after the first injection.
Slovenian: Če se klinični znaki ne izboljšajo ali če pride do poslabšanja, se lahko 5-15 minut po prvi injekciji da druga injekcija z dodatnim odmerkom zdravila [ime zdravila].
English: It is recommended that your family members, carers or teachers are also instructed in the correct use of [Invented name].
Slovenian: Priporočljivo je, da se tudi vaši družinski člani, skrbniki ali učitelji seznanijo z informacijami o pravilni uporabi zdravila [ime zdravila].
English: It is strongly advised also to educate the patient's immediate associates (e.g. parents, caregivers, teachers) for the correct usage of the [Invented name] in case support is needed in the emergency situation.
Slovenian: Zelo priporočljivo je tudi, da se s temi informacijami seznanijo tudi bližnje osebe bolnika (npr. starši, skrbniki, učitelji), da se zagotovi pravilna uporaba zdravila [ime zdravila] v primeru, da bolnik potrebuje pomoč v življenjsko nevarni situaciji.
English: For this reason you should carry more than one [Invented name] with you at all times.
Slovenian: Zato morate vedno imeti pri sebi več kot en peresnik zdravila [ime zdravila].
English: [The MAH(s) should submit improved diagram in the instructions for use by increasing the size and ensuring that it clearly shows that the injection should be in the antero-lateral aspect of the thigh]
Slovenian: [Imetnik dovoljenja za promet mora v Navodilo za uporabo priložiti izboljšano in povečano sliko, iz katere je jasno razvidno, da je treba zdravilo injicirati v anterolateralni del stegna.]
English: Annex III Amendments to relevant sections of the summary of product characteristics and package leaflet
Slovenian: Spremembe ustreznih poglavij povzetka glavnih značilnosti zdravila in navodila za uporabo
English: This Summary of Product Characteristics and package leaflet is the outcome of the referral procedure.
Slovenian: Ustrezna poglavja povzetka glavnih značilnosti zdravila in navodila za uporabo so rezultat napotitvenega postopka.
English: Section 4.4 - Special warnings and precautions for use [The section should be amended to reflect the following wording]
Slovenian: Poglavje 4.4 - Posebna opozorila in previdnostni ukrepi [To poglavje je potrebno spremeniti, tako da odraža naslednje besedilo.]
English: Section 3 - How to use [Invented name]
Slovenian: B. Navodila za uporabo Poglavje 3 - Kako uporabljati zdravilo [ime zdravila]
English: Section 3 - How to use [Invented name] [The section should be amended to reflect the following wording]
Slovenian: Poglavje 3 - Kako uporabljati zdravilo [ime zdravila] [To poglavje je potrebno spremeniti, tako da odraža naslednje besedilo.]
English: Section 6.5 - Nature and contents of container [The section should be amended to reflect the exposed needle length of the device(s)] [To be completed nationally]
Slovenian: Poglavje 6.5 - Vrsta ovojnine in vsebina [To poglavje je potrebno spremeniti, tako da je razvidna izpostavljena dolžina igle.]
English: Section 4.2 - Posology and method of administration [The section should be amended to reflect the following wording]
Slovenian: Poglavje 4.2 - Odmerjanje in način uporabe [To poglavje je potrebno spremeniti, tako da odraža naslednje besedilo.]
English: What [Invented name] looks like and contents of the pack [The section should be amended to reflect the exposed needle length of the device(s)] [To be completed nationally]
Slovenian: Izgled zdravila [ime zdravila] in vsebina pakiranja [To poglavje je potrebno spremeniti, tako da je razvidna izpostavljena dolžina igle.]
English: The European Commission issued a decision on this opinion on 26/6/17.
Slovenian: Evropska komisija je sklep o tem mnenju izdala dne 26/6/17.
English: Etopophos is marketed in the following EU member States: France, Germany, Sweden and the United Kingdom.
Slovenian: Zdravilo Etopophos se trži v naslednjih državah članicah EU: v Franciji, Nemčiji, na Švedskem in v Združenem kraljestvu.
English: The company that markets these medicines is Bristol-Myers Squibb.
Slovenian: Ta zdravila trži farmacevtska družba Bristol-Myers Squibb.
English: It is also available in the EU under the trade name Etopofos.
Slovenian: V EU je na voljo tudi pod trgovskim imenom Etopofos.
English: • testicular cancer, including cancer that is resistant to treatment or has come back;
Slovenian: • raka mod, vključno z rakom, ki je odporen proti zdravljenju ali pa se je ponovil;
English: On 21 April 2017, the European Medicines Agency completed a review of Etopophos.
Slovenian: Evropska agencija za zdravila je 21. aprila 2017 zaključila pregled zdravila Etopophos.
English: Etopophos is given as a slow intravenous infusion.
Slovenian: Zdravilo Etopophos se daje s počasno intravensko infuzijo.
English: Why was Etopophos reviewed?
Slovenian: Zakaj je bilo zdravilo Etopophos pregledano?
English: Etopophos is authorised in the EU via national procedures.
Slovenian: Zdravilo Etopophos je bilo v EU odobreno po nacionalnih postopkih.
English: • Hodgkin's and non-Hodgkin's lymphoma;
Slovenian: • Hodgkinovega in ne-Hodgkinovega limfoma;
English: Other sections of the SmPC harmonised include section 4.4 (special warnings and precautions), section 4.6 (fertility, pregnancy and lactation) and section 4.8 (undesirable effects).
Slovenian: Druga usklajena poglavja povzetka glavnih značilnosti zdravila zadevajo poglavje 4.4 (posebna opozorila in previdnostni ukrepi), poglavje 4.6 (plodnost, nosečnost in dojenje,) ter poglavje 4.8 (neželeni učinki).
English: • high-risk gestational trophoblastic neoplasia as first- and second-line treatments;
Slovenian: • visoko tvegane gestacijske trofoblastne neoplazije, kot zdravljenje prve in druge izbire;
English: What is Etopophos?
Slovenian: Kaj je zdravilo Etopophos?
English: This has led to divergences across Member States in the way the medicine can be used, as seen in the differences in the summaries of product characteristics (SmPCs), labelling and package leaflets in the countries where the medicine is marketed.
Slovenian: Zato je med državami članicami prišlo do razlik v načinu uporabe zdravila, kot je razvidno iz razlik v povzetkih glavnih značilnosti zdravila, označevanju in navodilih za uporabo v državah, v katerih se zdravilo trži.
English: The recommended dose for adults is 50 to 100 mg per m2 of body surface area for 5 days in a row or 100 to 120 mg/m2 on days 1, 3 and 5.
Slovenian: Priporočeni odmerek za odrasle je od 50 do 100 mg na m2 telesne površine pet zaporednih dni ali od 100 do 120 mg/m2 1., 3. in 5. dan. Cikel zdravljenja je mogoče ponoviti, vendar ne prej kot 21 dni po začetku prvega cikla.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that there is a need to harmonise the prescribing information for Etopophos and associated names in the European Union (EU).
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da je treba uskladiti podatke o predpisovanju zdravila Etopophos in povezanih imen v Evropski uniji (EU).
English: The CHMP recommended that Etopophos should be used in combination with other cancer treatments to treat the following cancers:
Slovenian: Odbor CHMP je priporočil, naj se zdravilo Etopophos uporablja v kombinaciji z drugimi zdravili proti raku za zdravljenje naslednjih vrst raka:
English: Etopophos is a cancer medicine used to treat: testicular cancer, lung cancer, ovarian cancer, gestational trophoblastic neoplasia (a rare tumour of the womb that occurs during pregnancy) and cancers of the blood (Hodgkin's and non-Hodgkin's lymphoma and acute myeloid leukaemia).
Slovenian: Zdravilo Etopophos je zdravilo proti raku, ki se uporablja za zdravljenje raka mod, pljučnega raka, raka jajčnikov, gestacijske trofoblastne neoplazije (redkega tumorja maternice, ki nastane med nosečnostjo) ter krvnih rakov (Hodgkinovega in ne-Hodgkinovega limfoma in akutne mieloične levkemije).
English: In addition, the CHMP recommended Etopophos for treating epithelial ovarian cancer that is resistant to treatments with platinum-containing medicines, with no specification that it should be used in combination with other medicines.
Slovenian: Poleg tega je odbor CHMP priporočil uporabo zdravila Etopophos za zdravljenje epitelijskega raka jajčnikov, odpornega proti zdravljenju z zdravili, ki vsebujejo platino, pri čemer ni podrobno navedel, da ga je treba uporabljati v kombinaciji z drugimi zdravili.
English: • acute myeloid leukaemia;
Slovenian: • akutne mieloične levkemije;
English: For blood cancers (Hodgkin's and non-Hodgkin's lymphoma and acute myeloid leukaemia), Etopophos is recommended for both adults and children, while its other uses are for adults only.
Slovenian: Zdravilo Etopophos je pri krvnih rakih (Hodgkinovem in ne-Hodgkinovem limfomu ter akutni mieloični levkemiji) priporočeno za odrasle in otroke, drugačne vrste uporabe pa so namenjene samo odraslim.
English: The areas of the SmPC harmonised include:
Slovenian: Usklajena področja povzetkov glavnih značilnosti zdravila so:
English: Etopophos contains the active substance etoposide (as etoposide phosphate) and is available as a powder to be made into a solution for infusion into a vein.
Slovenian: Zdravilo Etopophos vsebuje zdravilno učinkovino etopozid (v obliki etopozid fosfata) in je na voljo v obliki praška za pripravo raztopine za infundiranje v veno.
English: Etopophos should not be administered during vaccination with yellow fever or other live vaccines in patients with weakened immune systems and should not be given to breast-feeding women.
Slovenian: Pri bolnikih z oslabljenim imunskim sistemom se zdravilo Etopophos ne sme dajati med cepljenjem proti rumeni mrzlici ali z drugimi živimi cepivi, prav tako se ne sme dajati ženskam, ki dojijo.
English: On 14 October 2015, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Etopophos in the EU.
Slovenian: Da bi uskladili dovoljenja za promet z zdravilom Etopophos v EU, je Evropska komisija 14. oktobra 2015 napotila zadevo na odbor CHMP.
English: Etopophos was identified as needing harmonisation by the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh).
Slovenian: Skupina za usklajevanje za postopek z medsebojnim priznavanjem in decentralizirani postopekzdravila za uporabo v humani medicini (CMDh) je ugotovila, da je za zdravilo Etopophos potrebno usklajevanje.
English: EMA/251789/2017 Rev. 1
Slovenian: Vprašanja in odgovori v zvezi z zdravilom Etopophos in povezanimi imeni (etopozid, 100 in 1 000 mg, prašek za raztopino za infundiranje) EMA/251789/2017 Rev. 1
English: Moxifloxacin Moxifloxacin "Teva"
Slovenian: Moksifloksacin Moxifloxacin "Teva"
English: ANNEX I LIST OF THE PRODUCT NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES AND ICELAND
Slovenian: DODATEK I SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, POTI UPORABE ZDRAVILA, PREDLAGATELJEV, IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH IN ISLANDIJI
English: 3641 RT Mijdrecht Nederland
Slovenian: 3641 RT Mijdrecht Nizozemska
English: BayHealth - Comercialização de Produtos Farmacêuticos Unipessoal, Lda.
Slovenian: Portugalska BayHealth - Comercialização de Produtos Farmacêuticos Unipessoal, Lda.
English: Bravničarjeva 13 1000 Ljubljana Slovenia
Slovenian: Bravničarjeva 13 1000 Ljubljana Slovenija
English: 4745-457 S. Mamede do Coronado Portugal
Slovenian: 4745-457 S. Mamede do Coronado Portugalska
English: Netherlands Bayer BV Energieweg 1
Slovenian: Nizozemska Bayer BV Energieweg 1
English: Hungary Bayer Hungária Kft Alkotás ut.50
Slovenian: Madžarska Bayer Hungária Kft Alkotás ut.50
English: 2794-003 Carnaxide Portugal
Slovenian: 2794-003 Carnaxide
English: Berkshire RG14 1JA United Kingdom
Slovenian: Berkshire RG14 1JA Velika Britanija
English: RECORDATI ESPAÑA, SL Carretera De Zeneta, 149 30588 Beniel (Murcia) Spain
Slovenian: RECORDATI ESPAÑA, SL Carretera De Zeneta, 149 30588 Beniel (Murcia) Španija
English: Via M. Civitali, 1 20148 Milano Italy
Slovenian: Via M. Civitali, 1 20148 Milano Italija
English: BAYER SANTE 13, rue Jean Jaures 92807 PUTEAUX CEDEX France
Slovenian: BAYER SANTE 13, rue Jean Jaures 92807 PUTEAUX CEDEX Francija
English: 15125 Maroussi - Athens Greece
Slovenian: 15125 Maroussi - Athens Grčija
English: Viale Certosa, 130 20156 Milano Italy
Slovenian: Viale Certosa, 130 20156 Milano Italija
English: 151 25 Marousi - Athens Greece
Slovenian: 151 25 Marousi - Athens Grčija
English: Bayer Austria GmbH Herbststraße 6-10 1160 Wien Austria
Slovenian: Bayer Austria GmbH Herbststraße 6-10 1160 Wien Avstrija
English: Luxembourg Therabel Pharma 110 Rue Egide Van Ochem 1180 Bruxelles
Slovenian: Luksemburg Therabel Pharma 110 Rue Egide Van Ochem 1180 Bruxelles
English: Procter and Gamble Pharmaceuticals Iberia, SL WTC Almeda park, Edif 1, 2º planta 08940 Cornellá de Llobregat Barcelona
Slovenian: WTC Almeda park, Edif 1, 2º planta 08940 Cornellá de Llobregat Barcelona
English: BN22 9AG East Sussex United Kingdom
Slovenian: Teva UK Limited Brampton Road BN22 9AG East Sussex Velika Britanija
English: Moxifloxacin Avelox
Slovenian: Moksifloksacin Avelox
English: Belgium Therabel Pharma S.A. Rue Egide Van Ophem 108 1180 Bruxelles
Slovenian: Therabel Pharma S.A. Rue Egide Van Ophem 108 1180 Bruxelles Belgija
English: À Av. da Siderurgia Nacional P.O.
Slovenian: Portugalska Bialfar - Produtos À Av. da Siderurgia Nacional P.O. Box 56
English: Moxifloxacin Proflox
Slovenian: Moksifloksacin Proflox
English: Belgium Bayer s.a.-n.v. Avenue Louise 143 Louizalaan B-1050 Bruxelles Belgium
Slovenian: Avenue Louise 143 Louizalaan B-1050 Bruxelles Belgija
English: Moxifloxacin Infekt
Slovenian: Moksifloksacin Infekt
English: Film-coated tablet
Slovenian: Filmsko obložena tableta Peroralna uporaba
English: Luxembourg Bayer s.a.-n.v. Avenue Louise 143 Louizalaan 1050 Bruxelles
Slovenian: Avenue Louise 143 Louizalaan 1050 Bruxelles
English: 2800 Kongens Lyngby Denmark
Slovenian: Teva Denmark A/S, Parallelvej 10, 2800 Kongens Lyngby Danska
English: Bayer Vital GmbH 51368 Leverkusen Germany
Slovenian: Bayer Vital GmbH 51368 Leverkusen Nemčija
English: Bayer Health Care AG 51368 Leverkusen Germany
Slovenian: Bayer Health Care AG 51368 Leverkusen Nemčija
English: Avalox 400 mg Filmtabletten 400 mg Film-coated tablet
Slovenian: Avalox 400 mg Filmtabletten 400 mg Filmsko obložena tableta Peroralna uporaba
English: Bayer AG 51368 Leverkusen Germany
Slovenian: Bayer AG 51368 Leverkusen Nemčija
English: Avelox 400 mg - Filmtabletten 400 mg Film-coated tablet
Slovenian: Avelox 400 mg - Filmtabletten 400 mg Filmsko obložena tableta Peroralna uporaba
English: Netherlands Bayer HealthCare AG 51368 Leverkusen
Slovenian: Nizozemska Bayer HealthCare AG 51368 Leverkusen
English: Luxembourg Bayer Healthcare AG 51368 Leverkusen
Slovenian: Luksemburg Bayer Healthcare AG 51368 Leverkusen
English: Actira 400 mg film coated tablets400 mg Film-coated tablet
Slovenian: Actira 400 mg film coated tablets400 mg Filmsko obložena tableta Peroralna uporaba
English: Actimax 400 mg Filmtabletten 400 mg Film-coated tablet
Slovenian: Actimax 400 mg Filmtabletten 400 mg Filmsko obložena tableta Peroralna uporaba
English: Belgium Bayer AG 51368 Leverkusen Germany
Slovenian: Portugalska Bayer AG 51368 Leverkusen Nemčija
English: Actira 400 mg - Filmtabletten 400 mg Film-coated tablet
Slovenian: Actira 400 mg - Filmtabletten 400 mg Filmsko obložena tableta Peroralna uporaba
English: Octegra 400 mg - Filmtabletten 400 mg Film-coated tablet
Slovenian: Octegra 400 mg - Filmtabletten 400 mg Filmsko obložena tableta Peroralna uporaba
English: Actira 400 mg Filmtabletten 400 mg Film-coated tablet
Slovenian: Actira 400 mg Filmtabletten 400 mg Filmsko obložena tableta Peroralna uporaba
English: Moxafloxacin hydrochloride
Slovenian: Moksifloksacin Octegra
English: Bayer Hellas S.A.
Slovenian: Bayer Hellas S.A. Sorou 18-20
English: Octegra 400 mg Filmtabletten 400 mg Film-coated tablet
Slovenian: Octegra 400 mg Filmtabletten 400 mg Filmsko obložena tableta Peroralna uporaba
English: The response to the third part (iii) has been provided separately.
Slovenian: Odgovor na tretji del (iii) je podal ločeno.
English: According with Coupe A.J.
Slovenian: V skladu s Coupe A.J.
English: Absence of a Formulation Difference
Slovenian: Odsotnost razlike med formulacijama
English: During the course of the study, 80 adverse events were reported.
Slovenian: Med študijo so poročali o 80 neželenih dogodkih.
English: Safety results
Slovenian: Rezultati glede varnosti
English: The Applicant, given the degree of overlap between the first two parts of the question [(i) and (ii)] combined its response to these.
Slovenian: Predlagatelj je glede na stopnjo prekrivanja prvih dveh delov vprašanja [(i) in (ii)] podal skupen odgovor na ti dve vprašanji.
English: The samples were immediately stored at -25°C and transferred to the analytical facility.
Slovenian: Vzorci so bili takoj shranjeni pri -25 °C in preneseni v analitični laboratorij.
English: In conclusion, both results were considered to be fully acceptable.
Slovenian: Če povzamemo, veljata oba rezultata za povsem sprejemljiva.
English: All the available data were included without any imputation or extrapolation.
Slovenian: Vsi razpoložljivi podatki so bili vključeni brez imputacije ali ekstrapolacije.
English: The information on the originator product has been clarified to a satisfactory extent.
Slovenian: Informacije o originatorskem zdravilu so bile zadostno pojasnjene.
English: The detailed results of the long-term stability data of human samples were given.
Slovenian: Podani so bili podrobni rezultati podatkov o dolgoročni stabilnosti človeških vzorcev.
English: Initial Bioequivalence Studies
Slovenian: Začetni bioekvivalenčni študiji
English: For long-term stability a reduction was seen in pantoprazole content of between 6-8% of the nominal content, which was considered acceptable.
Slovenian: Pri preskusu dolgoročne stabilnosti je bilo opaženo zmanjšanje vsebnosti pantoprazola za 6-8 % nazivne vsebnosti, kar je veljalo za sprejemljivo.
English: The wash-out phase was 7 days.
Slovenian: Premor je trajal 7 dni.