FrancophonIA/ELRC3.0 huggingface dataset:
English: The MAHs proposes the following risk mitigation measure: “When spreading manure from treated animals, the minimum distance to surface water as defined in the national or local regulations has to be strictly respected, because the manure may contain altrenogest which could cause adverse effects in the aquatic environment”.
Slovenian: Imetniki dovoljenja za promet z zdravilom predlagajo naslednji ukrep za zmanjšanje tveganja: „Pri nanašanju gnoja zdravljenih živali je treba natančno upoštevati najmanjšo razdaljo do površinske vode, kot jo določajo nacionalni ali lokalni predpisi, ker lahko gnoj vsebuje altrenogest, ki bi v vodnem okolju lahko povzročil škodljive učinke.“
English: For the Phase I the PECsoil initial for gilts, sows and mares was established using the daily doses and the default values from the CVMP guideline on environmental impact assessment for veterinary medicinal products in support of the VICH guidelines GL6 and GL 38 (EMEA/CVMP/418282/2005Rev.1).
Slovenian: Začetna vrednost PECtla za svinje mladice, svinje in kobile za I. fazo je bila določena s pomočjo dnevnih odmerkov in privzetih vrednosti iz smernice odbora CVMP o oceni vpliva zdravil za uporabo v veterinarski medicini na okolje v podporo smernicama VICH GL6 in GL38 (EMEA/CVMP/418282/2005-Rev.1).
English: • the CVMP considered that veterinary medicinal products containing altrenogest are essential in modern pig production since the oestrus synchronisation of gilts is a tool facilitating strict batch farrowing with obvious benefits for the management and hygiene in these farms, and consequently the health of the animals;
Slovenian: • odbor CVMP je upošteval, da so zdravila za uporabo v veterinarski medicini, ki vsebujejo altrenogest, nujna v sodobni prašičereji, saj je sinhronizacija estrusa svinj mladic orodje, ki omogoča točno serijsko prasitev in tako prinaša očitne koristi pri upravljanju in higieni na zadevnih kmetijah in posledično pri zdravju živali;
English: Intervet International Wim de Korverstraat 35 P.O.
Slovenian: Intervet International Wim de Korverstraat 35 P.O. Box 31
English: However, veterinary medicinal products containing altrenogest are essential in modern pig production since the synchronisation of gilts is a tool facilitating strict batch farrowing, with obvious benefits for the management and hygiene in these farms, and consequently the health of the animals.
Slovenian: Kljub temu so zdravila za uporabo v veterinarski medicini, ki vsebujejo altrenogest, nujna v sodobni prašičereji, saj je sinhronizacija svinj mladic orodje, ki omogoča točno serijsko prasitev in tako prinaša očitne koristi pri upravljanju in higieni na zadevnih kmetijah in posledično pri zdravju živali.
English: Veterinary medicinal products containing altrenogest are essential in modern pig production, as the synchronisation of gilts is a tool facilitating strict batch farrowing, with obvious benefits for the management and hygiene in these farms, and consequently the health of the animals.
Slovenian: Zdravila za uporabo v veterinarski medicini, ki vsebujejo altrenogest, so nujna v sodobni prašičereji, saj je sinhronizacija svinj mladic orodje, ki omogoča točno serijsko prasitev in tako prinaša očitne koristi pri upravljanju in higieni na zadevnih kmetijah in posledično pri zdravju živali.
English: Slovakia Intervet Ltd Cookstown
Slovenian: Intervet Ltd Cookstown Tallaght Dublin 24
English: Germany considered that, although according to the VICH GL6: Guideline on environmental impact assessment (EIAs) for veterinary medicinal products - Phase I2, the estimated Predicted Environmental Concentrations in soil (PECsoil) for altrenogest (<100 µg/kg) would not trigger a Phase II ERA, hazard concerns related to endocrine disruption and identified in structurally very similar molecules, require a deeper understanding of the potential environmental impacts of altrenogest when used following the recommended use, and a tailored Phase II ERA is consequently considered necessary.
Slovenian: faze ocene tveganja za okolje, je po mnenju Nemčije zaradi pomislekov glede nevarnosti, povezanih z endokrinimi motnjami, ki so bile ugotovljene v molekulah z zelo podobno strukturo, treba podrobneje poznati morebitne vplive altrenogesta na okolje ob priporočljivem načinu uporabe in je zato potrebna prilagojena II.
English: Route of administration
Slovenian: Način in pot uporabe
English: Spain aniMedica GmbH Im Sudfeld
Slovenian: Španija aniMedica GmbH Im Sudfeld
English: The anaerobic transformation of altrenogest was investigated in pig manure incubated anaerobically according to the CVMP guideline on determining the fate of veterinary medicinal products in manure (EMA/CVMP/ERA/430327/2009)3.
Slovenian: Anaerobno pretvorbo altrenogesta so preučevali v anaerobno inkubiranem svinjskem gnoju skladno s smernico odbora CVMP o ugotavljanju obnašanja zdravil za uporabo v veterinarski medicini v
English: When spreading manure from treated animals, the minimum distance to surface water as defined in the national or local regulations has to be strictly respected, because the manure may contain altrenogest which could cause adverse effects in the aquatic environment.
Slovenian: Pri nanašanju gnoja zdravljenih živali je treba natančno upoštevati najmanjšo razdaljo do površinske vode, kot jo določajo nacionalni ali lokalni predpisi, ker lahko gnoj vsebuje altrenogest, ki bi v vodnem okolju lahko povzročil škodljive učinke.
English: No NOEC (No-Observed Effect Concentration) could be derived (NOEC <0.4 ng/l) for altrenogest from the study, especially as analytical limitations proved difficult any further decrease in test concentrations.
Slovenian: Iz študije ni bilo mogoče izpeljati koncentracije brez opaženega učinka (NOEC < 0,4 ng/l) za altrenogest, zlasti ker
English: Metabolism data
Slovenian: Metrologielaan 6
English: Hungary aniMedica GmgH, Im Südfeld 9
Slovenian: Madžarska aniMedica GmgH, Im Südfeld 9
English: United Kingdom aniMedica GmbH Im Sudfeld
Slovenian: Združeno kraljestvo aniMedica GmbH Im Sudfeld
English: 0.4% w/v Oral suspension Pigs
Slovenian: 0.4% w/v Peroralna raztopina Prašiči
English: Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands
Slovenian: Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands
English: 40 pg/l was established.
Slovenian: Zato so določili vrednost PNEC pod 40 pg/l.
English: Poland Intervet International B.V. Wim de Körverstraat B.V.
Slovenian: Wim de Körverstraat B.V.
English: France aniMedica GmbH Im Südfeld 9
Slovenian: Francija aniMedica GmbH Im Südfeld 9
English: Romania aniMedica GmbH Im Südfeld 9
Slovenian: Romunija aniMedica GmbH Im Südfeld 9
English: However, for buffer zone calculations, which represent the highest tier exposure scenario, the entire representative R-scenario set is recommended.
Slovenian: Kljub temu je za izračune varovalnih pasov, ki predstavljajo scenarij najvišje stopnje izpostavljenosti, priporočen celoten niz reprezentativnih scenarijev R. Scenarija R1 (zemljišča v srednji Evropi) in R3 (srednje evropsko Sredozemlje) (ne pa scenarij R2) sta pomembna tudi za ozimna žita, kot je predlagano v poročilu FOCUS-SW, in ju je tudi treba izračunati.
English: Maximum PECsurfacewater concentrations were calculated using FOCUS STEP 4 modelling for all representative scenarios for different buffer zone (1 m, 3 m, 5 m, 10 m (Directive 91/676/EEC) These buffer zones are minimum distances to surface water which must be maintained when manure (or organic fertilizer) is spread onto cropland for the protection of waters against pollution caused by nitrates from agricultural sources which is implemented in national law in the EU Member States.
Slovenian: Najvišje koncentracije PECpovršinska voda so bile izračunane s pomočjo 4. koraka modela FOCUS za vse reprezentativne scenarije za različne varovalne pasove (1 m, 3 m, 5 m, 10 m) (Direktiva 91/676/EGS).
English: The Netherlands aniMedica GmbH Im Südfeld 9
Slovenian: Nizozemska aniMedica GmbH Im Südfeld 9
English: MG/ML SOLUT ION BUVABLE POUR CHEVAUX
Slovenian: REGUMATE EQUIN 2,2 MG/ML SOLUT ION BUVABLE POUR CHEVAUX
English: Regumate Equine 2.2 mg/ml oral solution for horses
Slovenian: Regumate Equine 2.2 mg/ml oral solution for Konji
English: Regumate Equine 2.2 mg/ml Oral Solution for Horses
Slovenian: Regumate Equine 2.2 mg/ml Oral Solution for Konji
English: Belgium Ceva Santé Animale N.V. Metrologielaan 6
Slovenian: Ceva Santé Animale N.V.
English: 0.4% w/w Oral solution Pigs
Slovenian: 0.4% w/w Peroralna raztopina Prašiči
English: Poland AniMedica GmbH Im Südfeld 9
Slovenian: AniMedica GmbH Im Südfeld 9
English: Other precautions regarding impact on the environment When spreading manure from treated animals, the minimum distance to surface water as defined in the national or local regulations has to be strictly respected, because the manure may contain altrenogest which could cause adverse effects in the aquatic environment.
Slovenian: POSEBNO(A) OPOZORILO(A), ČE JE/SO POTREBNO(A) Pri gnojenju z gnojem zdravljenih živali je treba strogo upoštevati državne in lokalne predpise glede minimalne oddaljenosti od površinskih vod, ker gnoj lahko vsebuje altrenogest, ki bi lahko povzročil neželene učinke v vodnem okolju.
English: EU/1/07/416/002 Ecalta
Slovenian: EU/1/07/416/002
English: 100 mg Powder for concentrate for solution for infusion
Slovenian: 100 mg prašek za koncentrat za raztopino za injiciranje intravenska uporaba viala (steklo)
English: MA (EU) number Name Strength Pharmaceutical Form
Slovenian: (Izmišljeno) ime Jakost Farmacevtska oblika
English: Pack size
Slovenian: ECALTA
English: (Invented) name
Slovenian: (Izmišljeno) name
English: (Invented) name
Slovenian: (Lastniško ime)
English: Powder for concentrate for solution for infusion
Slovenian: 29 mg prašek za pripravo koncentrata za pripravo raztopine za infundiranje intravenska uporaba viala (steklena) 1 viala
English: This summary was last updated on 14.01.2010.
Slovenian: Povzetek je bil nazadnje posodobljen 14.01.2010.
English: The vaccine also contains ‘adjuvants' to stimulate a better response.
Slovenian: Cepivo vsebuje tudi „adjuvanse“ za spodbujanje boljšega odziva.
English: This protects the pigs against the disease.
Slovenian: To bo zaščitilo prašiče pred boleznijo.
English: Vaccines work by ‘teaching' the immune system (the body's natural defences) how to defend itself against a disease.
Slovenian: Cepiva delujejo tako, da imunski sistem (naravni obrambni mehanizem telesa) „naučijo“, kako naj se brani pred boleznimi.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Gripovac 3 to Merial on 14.01.2010.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Gripovac 3, veljavno po vsej Evropski uniji, odobrila družbi Merial dne 14.01.2010.
English: Sometimes, a slight increase in the rectal temperature might occur after vaccination.
Slovenian: Občasno se lahko po cepljenju rahlo poviša rektalna temperatura.
English: Gripovac 3 is a suspension for injection.
Slovenian: Zdravilo Gripovac 3 je suspenzija za injiciranje.
English: What is the time to allow before the animal can be slaughtered and the meat used for human consumption (withdrawal period)?
Slovenian: Koliko časa mora preteči, preden se lahko žival zakolje in meso porabi za prehrano ljudi
English: When a pig is given the vaccine, the immune system recognises the killed viruses as ‘foreign' and makes antibodies against them.
Slovenian: Ko prašiča cepimo, imunski sistem prepozna uničene viruse kot „tujke“ in proti njim razvije protitelesa.
English: What benefit has Gripovac 3 shown during the studies?
Slovenian: Kakšne koristi je zdravilo Gripovac 3 izkazalo med študijami?
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) GRIPOVAC 3 EPAR summary for the public
Slovenian: GRIPOVAC 3 Povzetek EPAR za javnost
English: Gripovac 3 is a vaccine.
Slovenian: Zdravilo Gripovac 3 je cepivo.
English: A slight swelling may occur after vaccination at the site of injection in a small number of pigs but this goes down within 2 days.
Slovenian: Pri majhnem številu prašičev se lahko na mestu injiciranja pojavi manjša oteklina, ki pa mine v 2 dneh.
English: Gripovac 3 contains small amounts of a modified and then killed form of the pig's influenza virus that causes lesions and illness.
Slovenian: Zdravilo Gripovac 3 vsebuje majhne količine spremenjene in nato uničene oblike virusa prašičje influence, ki povzroča lezije in bolezen.
English: Gripovac 3 is a vaccine that contains 3 different strains of swine influenza A virus which have been inactivated (killed).
Slovenian: Zdravilo Gripovac 3 je cepivo, ki vsebuje 3 različne seve virusa prašičje influence A, ki so bili inaktivirani (uničeni).
English: Other information about Gripovac 3:
Slovenian: Druge informacije o zdravilu Gripovac 3:
English: In the future, the immune system will be able to produce antibodies more quickly when it is again exposed to the viruses.
Slovenian: Ob ponovni izpostavitvi virusom v prihodnosti bo imunski sistem tako hitreje tvoril protitelesa hitreje.
English: In case of accidental self-injection only a minor injection site reaction is expected.
Slovenian: V primeru nenamernega samoinjiciranja lahko pride do blage reakcije na mestu injiciranja.
English: The effectiveness of Gripovac 3 has been studied in animals 56 days of age and older and in sows before and during pregnancy and these studies document that the vaccine protects against swine influenza.
Slovenian: Učinkovitost zdravila Gripovac 3 so proučevali pri živalih, starejših od 56 dni, in pri svinjah pred in med brejostjo, te študije pa so pokazale, da jih cepivo ščiti pred prašičjo influenco.
English: What is the risk associated with Gripovac 3?
Slovenian: Kakšna tveganja so povezana z zdravilom Gripovac 3?
English: Use of the Gripovac 3 in pigs reduces clinical signs and reduces the amount of virus in the lungs after infection caused by swine influenza A virus.
Slovenian: Uporaba zdravila Gripovac 3 pri prašičih zmanjša klinične znake in zmanjša prisotnost virusa v pljučih po okužbi, ki jo povzroči virus prašičje influence A.
English: Why has Gripovac 3 been approved?
Slovenian: Zakaj je bilo zdravilo Gripovac 3 odobreno?
English: Gripovac 3 is also used to vaccinate pregnant sows following their first immunisation by giving them one dose 14 days prior to farrowing in order that the sows milk contains enough antibodies to help protect the piglets against swine influenza for at least 33 days after birth.
Slovenian: Zdravilo Gripovac 3 se prav tako uporablja za cepljenje brejih svinj po prvi imunizaciji, z dajanjem enega odmerka 14 dni pred prasitvijo, da mleko svinj vsebuje dovolj protiteles, ki pujske ščijo pred prašičjo influenco vsaj 33 dni po rojstvu.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Gripovac 3 exceed the risks for the vaccination of pigs from the age of 56 days onwards inluding pregnant sows against swine influenza caused by subtypes H1N1, H3N2 and H1N2 to reduce clinical signs and viral lung load after infection and recommended that Gripovac 3 be given a marketing authorisation.
Slovenian: Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je zaključil, da so koristi zdravila Gripovac 3 za cepljenje prašičev od 56 dneva starosti naprej, vključno z brejimi svinjami, proti influenci prašičev, ki jo povzročajo podtipi H1N1, H3N2 in H1N2, za zmanjšanje kliničnih znakov in prisotnosti virusa v pljučih po okužbi, večje od tveganj, in priporočil, da se za zdravilo Gripovac 3 odobri dovoljenje za promet.
English: What is Gripovac 3 used for?
Slovenian: Za kaj se zdravilo Gripovac 3 uporablja?
English: What is Gripovac 3?
Slovenian: Kaj je zdravilo Gripovac 3?
English: Gripovac 3 is used to vaccinate pigs including pregnant sows over the age of 56 days against swine influenza in order to help them clinically but also to reduce the amount of virus present in the lungs.
Slovenian: Zdravilo Gripovac 3 se uporablja za cepljenje prašičev od 56 dneva starosti naprej, vključno z brejimi svinjami, proti prašičji influenci za zmanjšanje kliničnih znakov in prisotnosti virusa v pljučih.
English: How has Gripovac 3 been studied?
Slovenian: Kako je bilo zdravilo Gripovac 3 raziskano?
English: EU/1/18/1291/005 EU/1/18/1291/006
Slovenian: EU/1/18/1291/003 EU/1/18/1291/004 EU/1/18/1291/005 EU/1/18/1291/006
English: 84 tablets 10 tablets 30 tablets 100 tablets
Slovenian: 84 tablet 10 tablet 30 tablet 100 tablet
English: Oral use Oral use Oral use Oral use blister (OPA/alu/PVC/alu) blister (OPA/alu/PVC/alu) blister (OPA/alu/PVC/alu) blister (OPA/alu/PVC/alu)
Slovenian: 200 µg 200 µg 200 µg 200 µg filmsko obložena tableta filmsko obložena tableta filmsko obložena tableta filmsko obložena tableta peroralna uporaba peroralna uporaba peroralna uporaba peroralna uporaba pretisni omot (OPA/alu/PVC/alu) pretisni omot (OPA/alu/PVC/alu) pretisni omot (OPA/alu/PVC/alu pretisni omot (OPA/alu/PVC/alu
English: The median time to event was nine days.
Slovenian: Mediani čas do dogodka je bil devet dni.
English: Date of first authorisation: 26 April 2019
Slovenian: Datum prve odobritve: 26. april 2019
English: Read all of this leaflet carefully, because it contains important information for you.
Slovenian: Natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
English: < 8 hours or unknown
Slovenian: < 8 ur ali neznano
English: The dissolution time for each vial is approximately three to five minutes.
Slovenian: Čas raztapljanja za vsako vialo je približno tri do pet minut.
English: Validation has not been successful, yet.
Slovenian: Potrditev doslej še ni bila uspešna.
English: Please note this medicine is mainly used in emergency situations, and the doctor will have decided that you needed it.
Slovenian: Upoštevajte, da se to zdravilo večinoma uporablja v nujnih primerih in da bo zdravnik odločil, ali ga potrebujete.
English: Before starting reconstitution, you will need the following:
Slovenian: Pred začetkom rekonstitucije boste potrebovali naslednje:
English: ATC code: V03AB38
Slovenian: Oznaka ATC: V03AB38
English: ≥ 8 hours
Slovenian: ≥ 8 ur
English: In an updated interim analysis, data of 352 patients were evaluated.
Slovenian: V posodobljeni vmesni analizi so ocenili podatke 352 bolnikov.
English: Frequency in healthy volunteers
Slovenian: Pogostnost pri zdravih prostovoljcih
English: Pharmacotherapeutic group: All other therapeutic products, antidotes.
Slovenian: Farmakoterapevtska skupina: Vsa druga zdravila, antidoti.
English: This medicine will be stored in the hospital, and these instructions are intended for hospital staff only.
Slovenian: To zdravilo bo shranjeno v bolnišnici in ta navodila so namenjena samo bolnišničnemu osebju.
English: Duration of this effect in bleeding patients is not known.
Slovenian: Trajanje tega učinka pri krvavečih bolnikih ni znano.
English: Your doctor or nurse will work out the dose of this medicine that you need.
Slovenian: Zdravnik ali medicinska sestra bosta določila količino tega zdravila, ki jo potrebujete.
English: The elimination halflife ranges from four to seven hours.
Slovenian: Razpolovni čas izločanja je od štiri do sedem ur.
English: Your doctor or nurse will give you this medicine by injection or infusion into a vein.
Slovenian: Zdravnik ali medicinska sestra vam bosta dala to zdravilo z injekcijo ali infuzijo v veno.
English: There were no blood clots in these healthy people.
Slovenian: Pri teh zdravih osebah ni bilo krvnih strdkov.
English: • Calculated number of vials as given in table 1.
Slovenian: • Izračunano število vial, kot je podano v preglednici 1.
English: Haemostatic efficacy was good or excellent in 81.9% of 249 patients.
Slovenian: Hemostatska učinkovitost je bila dobra ali odlična pri 81,9 % od 249 bolnikov.
English: • effects on blood clotting markers: some markers which affect blood clotting were increased for a little while and then returned to normal.
Slovenian: • učinki na označevalce strjevanja krvi: nekateri označevalci, ki vplivajo na strjevanje krvi, so bili krajši čas zvišani, nato pa so se vrnili na normalno vrednost.
English: Monitoring for signs and symptoms of thrombosis is, therefore, strongly recommended.
Slovenian: Zato se močno priporoča spremljanje znakov in simptomov tromboze.
English: Tell your doctor if you are taking, have recently taken, or might take, any other medicines.
Slovenian: Obvestite zdravnika, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
English: Approximately half of the patients were male, and the mean age was 77.4 years.
Slovenian: Približno polovica bolnikov je bila moškega spola, povprečna starost pa je bila 77,4 leta.
English: Dosage recommendation is based upon data-modelling in healthy volunteers.
Slovenian: Priporočila za odmerjanje temeljijo na modeliranju podatkov pri zdravih prostovoljcih.
English: These elevations were maintained between several hours to a few days following administration, but no thrombotic events were reported.
Slovenian: Ta zvišanja so se ohranila od nekaj ur do več dni po aplikaciji, vendar niso poročali o trombotičnih dogodkih.
English: Based on its mechanism of action and on the characteristics of proteins, no carcinogenic or genotoxic effects are anticipated.
Slovenian: Na podlagi njegovega mehanizma delovanja in značilnosti beljakovin niso pričakovani kancerogeni ali genotoksični učinki.
English: • if you are allergic to andexanet alfa or any of the other ingredients of this medicine (listed in section 6).
Slovenian: • če ste alergični na andeksanet alfa ali katero koli sestavino tega zdravila (navedeno v poglavju 6),
English: Each pack contains four vials.
Slovenian: Eno pakiranje vsebuje štiri viale.
English: • Calculated number of vials (see section 4.2).
Slovenian: • Izračunano število potrebnih vial (glejte poglavje 4.2).
English: Do not use if opaque particles or discolouration are present.
Slovenian: Ne uporabite, če so prisotni neprosojni delci ali obarvanje.
English: PK/PD modelling
Slovenian: FK/FD modeliranje
English: • Water for injections
Slovenian: • Vodo za injekcije.
English: Annex IV Conclusions on the granting of the conditional marketing authorisation presented by the European Medicines Agency
Slovenian: Priloga IV Sklepne ugotovitve o pridobitvi pogojnega dovoljenja za promet z zdravilom, ki jih je predstavila Evropska agencija za zdravila
English: Remove the flip-top from each vial.
Slovenian: Z vsake viale odstranite pokrovček flip-top.
English: DO NOT SHAKE the vials, as this can lead to foaming.
Slovenian: Vial NE STRESAJTE, saj bi to lahko povzročilo penjenje.
English: These levels of unbound FXa inhibitor provide little or no anticoagulant effect.
Slovenian: Te ravni nevezanih zaviralcev FXa imajo malo ali nič antikoagulacijskega učinka.
English: • rapid or irregular heartbeat
Slovenian: • hitro ali nepravilno bitje srca,
English: Elderly patients (aged 65 years and over): No dose adjustment is required in elderly patients (see section 5.2).
Slovenian: Starejši bolniki (stari 65 let in več): Pri starejših bolnikih prilagoditev odmerka ni potrebna (glejte poglavje 5.2).
English: Each vial is reconstituted according to the following instructions:
Slovenian: Vsako vialo je treba rekonstituirati skladno z naslednjimi navodili:
English: The updated interim analysis demonstrated that the change in anti-FXa activity (surrogate) was not predictive for achievement of hemostatic efficacy in the overall patient population.
Slovenian: Posodobljena vmesna analiza je pokazala, da sprememba aktivnosti proti FXa (surogat) ni bila napovedna za doseganje hemostatske učinkovitosti pri splošni populaciji bolnikov.
English: There is no information on the use of Ondexxya in children and adolescents.
Slovenian: Informacij o uporabi zdravila Ondexxya pri otrocih in mladostnikih ni.
English: The clinical relevance of this interaction in terms of maintenance of thrombin generation and the potential for a prothrombotic effect has not been fully elucidated.
Slovenian: Klinični pomen te interakcije z vidika vzdrževanja tvorbe trombina in potenciala za protrombotični učinek še ni v celoti pojasnjen.
English: Conditional approval
Slovenian: Pogojno dovoljenje
English: Submission by 30 September
Slovenian: 30. septembra