FrancophonIA/ELRC3.0 huggingface dataset:
English: Cavoley is a medicine that contains the active substance pegfilgrastim, which stimulates the production of neutrophils (a type of white blood cell that fights infections).
Slovenian: Cavoley je zdravilo, ki vsebuje zdravilno učinkovino pegfilgrastim, ki spodbuja nastajanje nevtrofilcev (vrste belih krvnih celic, ki se borijo proti okužbam).
English: Cavoley was to be used in cancer patients to reduce neutropenia (low levels of neutrophils).
Slovenian: Zdravilo Cavoley naj bi se uporabljajo pri bolnikih z rakom za zmanjševanje nevtropenije (nizkih ravni nevtrofilcev).
English: Based on the review of the data and the company's response to the CHMP list of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Cavoley could not have been approved for reducing neutropenia.
Slovenian: Odbor CHMP je na podlagi pregleda podatkov in odgovorov družbe na sezname vprašanj, ki jih je zastavil, ob umiku vloge izrazil določene zadržke in je začasno menil, da zdravila Cavoley ni mogoče odobriti za zmanjševanje nevtropenije.
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that the company had not demonstrated that Cavoley is highly similar to Neulasta.
Slovenian: Zato je odbor CHMP ob umiku vloge menil, da družba ni dokazala, da je zdravilo Cavoley zelo podobno zdravilu Neulasta.
English: The CHMP was concerned that study results had not shown that Cavoley was handled by the body in the same way as the reference medicine Neulasta.
Slovenian: Izrazil je zaskrbljenost, da rezultati študije niso dokazali, da telo zdravilo Cavoley presnavlja na enak način kot referenčno zdravilo Neulasta.
English: Cavoley was to be used to reduce the duration of neutropenia and the occurrence of febrile neutropenia (neutropenia with fever).
Slovenian: Zdravilo Cavoley naj bi se uporabljalo za skrajšanje nevtropenije ter zmanjšanje pojavljanja febrilne nevtropenije (nevtropenije s povišano telesno temperaturo).
English: The vaccine is then ready to use.
Slovenian: Cepivo je potem pripravljeno za uporabo.
English: Then remove the trocar from both containers.
Slovenian: Potem odstranite trokar iz obeh vsebnikov.
English: Do not use in birds in lay (see section 4.3).
Slovenian: Ne uporabite pri pticah v obdobju nesnosti (glejte poglavje 4.3).
English: Store and transport refrigerated (2° C - 8° C).
Slovenian: Shranjujte in prevažajte v hladilniku (2 °C - 8 °C).
English: Due to the limited period the veterinary medicinal product Parvoduk has been placed on the market and the consequently limited post-marketing safety information, the CVMP at their meeting on 6-8 November 2018 decided that one five-year renewal is required.
Slovenian: Zaradi kratkega časovnega obdobja od dajanja zdravila za uporabo v veterinarski medicini Parvoduk na trg in posledično omejenih informacij o varnosti po začetku trženja, je CVMP 6-8 novembra 2018 odločil, da je potrebno še eno petletno podaljšanje dovoljenja za promet.
English: Concentrate:
Slovenian: Koncentrat:
English: ANNEX IV GROUNDS FOR ONE ADDITIONAL RENEWAL
Slovenian: PRILOGA IV PODLAGA ZA DODATNO PODALJŠANJE ZA PROMET
English: The excipients listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or are considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Slovenian: SPC - dovoljene snovi, za katere tabela 1 priloge Uredbe Komisije (EU) št. 37/2010 določa, da MRL ni potreben ali pa, ne spadajo v področje uporabe Uredbe (ES) št. 470/2009, kadar so uporabljene tako kot v tem zdravilu za uporabo v veterinarski medicini.
English: b) the disease to which the product is intended to confer immunity is largely absent from the territory in question
Slovenian: b) bolezen, za katero se z zdravilom pridobi imunost, na zadevnem območju skoraj ni prisotna.
English: C T C G C C C A A T A The vaccine strain can be found in the spleen for at least 35 days.
Slovenian: C T C G C C C A A T A Cepni sev je lahko v vranici prisoten vsaj 35 dni.
English: Laboratoire Porte des Alpes Rue de l'Aviation 69800 Saint Priest FRANCE
Slovenian: Laboratoire Porte des Alpes Rue de l'Aviation 69800 Saint Priest Francija
English: SPECIAL STORAGE CONDITIONS Store below 25° C.
Slovenian: POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte pri temperaturi pod 25° C.
English: Do not use this veterinary medicinal product after the expiry date which is stated on the carton after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na ovojnini po EXP.
English: Casein hydrolysate Aluminium hydroxide
Slovenian: Hidrolizat kazeina Aluminijev hidroksid
English: Detailed information of this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
Slovenian: Podrobne informacije o tem zdravilu so na voljo na spletni strani Evropske agencije za zdravila (European Medicines Agency) (http://www.ema.europa.eu/.
English: - Second vaccination: at 17 days of age.
Slovenian: - Drugi odmerek: pri 17 dnevih starosti.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 11/04/2014
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum pridobitve dovoljenja za promet:11/04/2014
English: After mixing, connect the bag to a high-speed, automated or semi-automated injection system.
Slovenian: Po mešanju povežite vrečko z avtomatskim ali pol-avtomatskim hitrim sistemom za injiciranje.
English: MANUFACTURER'S BATCH NUMBER Lot
Slovenian: PROIZVAJALČEVA ŠTEVILKA SERIJE Lot
English: Eleven genetic markers (nucleotides) in the VP1 gene allow differentiation of the Parvoduk vaccine strain from the field strains of duck and goose parvovirus, as shown below:
Slovenian: Enajst genetskih markerjev (nukleotidov) na VP1 genu omogoča diferenciacijo Parvoduk cepnega seva od terenskih izolatov parvovirusa rac in gosi, kot je prikazano spodaj:
English: Goose Parvovirus
Slovenian: Parvovirus gosi
English: Administer one dose of 0.2 ml by subcutaneous injection according to the following vaccination scheme: - First vaccination: at 1 day of age.
Slovenian: Injicirajte en odmerek (0,2 ml) subkutano po naslednji shemi cepljenja: - Prvi odmerek: pri 1 dnevu starosti.
English: Manufacturer responsible for batch release: MERIAL
Slovenian: Proizvajalec odgovoren za sproščanje serij: MERIAL
English: The concentrate is opalescent and homogeneous.
Slovenian: Koncentrat je opalescenten in homogen.
English: Sodium chloride Potassium chloride Potassium dihydrogen phosphate Disodium phosphate dehydrate Water for injections.
Slovenian: Natrijev klorid Kalijev klorid Kalijev dihidrogenfosfat Dinatrijev fosfat, dehidriran Voda za injekcije
English: Duration of immunity: 26 days after the primary vaccination course
Slovenian: Trajanje imunosti: do 26 dni po osnovnem cepljenju.
English: In ducklings free of maternally derived antibodies a single vaccination at day 1 will lead to an onset of immunity after 14 days.
Slovenian: Pri mladičih brez maternalnih protiteles enkratno cepljenje pri 1 dnevu starosti povzroči nastanek imunosti v trajanju 14 dni.
English: No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicine.
Slovenian: Ni podatkov o varnosti ter učinkovitosti ob uporabi tega cepiva s katerim koli drugim zdravilom za uporabo v veterinarski medicini.
English: Special precaution for use in animals:
Slovenian: Posebni previdnostni ukrepi za uporabo pri živalih:
English: Name and address of the manufacturer(s) of the biological active substance(s)
Slovenian: Ime in naslov proizvajalca (proizvajalcev) biološke (bioloških) učinkovine (učinkovin)
English: Onset of immunity: 11 days after the primary vaccination course
Slovenian: Nastop imunosti: 11 dni po osnovnem cepljenju.
English: Administer one dose of 0.2 ml by subcutaneous injection according to the following vaccination scheme:
Slovenian: Injicirajte en odmerek (0,2 ml) subkutano po naslednji shemi cepljenja:
English: Overdose (symptoms, emergency procedures, antidotes): No adverse reactions were observed after the administration of an overdose (10x the dose).
Slovenian: Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi): Po dajanju prevelikega odmerka ni neželenih učinkov (10-kratni odmerek).
English: The demonstrated duration of immunity protects the birds during the period when they are most susceptible to Muscovy duck parvovirosis and Derzsy's disease.
Slovenian: Trajanje imunosti zaščiti ptice v starostnem obdobju, ko so najbolj dovzetne za okužbo s parvovirusom rac moškatnih bleščavk in Derzsyjevo bolezen.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES 500 doses
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ODMERKOV 500 odmerkov
English: Shelf life after dilution according to directions: 4 hours
Slovenian: Rok uporabnosti po razredčenju v skladu z navodili: 4 ure.
English: Antigen concentrate:
Slovenian: Koncentrat antigena:
English: Type I glass vials with butyl elastomer closure.
Slovenian: Viala iz stekla tipa I z butil elastomernim pokrovčkom.
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS Each reconstituted dose of 0.2 ml contains:
Slovenian: NAVEDBA UČINKOVIN(E) IN DRUGE(IH) SESTAVIN Vsak rekonstituiran odmerek (0,2 ml) vsebuje:
English: One reconstituted dose of 0.2 ml contains:
Slovenian: En rekonstituiran odmerek (0,2 ml) vsebuje:
English: Polypropylene bags with butyl elastomer closure and trocar.
Slovenian: Polipropilenske vrečke z butil elastomernim pokrovčkom in trokarjem.
English: CONTRAINDICATIONS Do not use in birds in lay.
Slovenian: KONTRAINDIKACIJE Ne uporabite pri pticah v obdobju nesnosti.
English: Transfer the content of the glass vial into the bag of diluent.
Slovenian: Prenesite vsebino viale v vrečko z vehiklom.
English: Duck Parvovirus
Slovenian: Parvovirus rac
English: EXP Once diluted, use within 4 hours.
Slovenian: EXP Razredčeno zdravilo uporabite v 4 urah.
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) Live attenuated Muscovy duck parvovirus.
Slovenian: KOLIČINA UČINKOVIN(E) Živ atenuiran parvovirus rac moškatnih bleščavk.
English: Once diluted use within 4 hours.
Slovenian: Razredčeno zdravilo uporabite v 4 urah.
English: A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. PROIZVAJALEC (PROIZVAJALCI) BIOLOŠKE (BIOLOŠKIH) UČINKOVINE (UČINKOVIN) IN PROIZVAJALEC (PROIZVAJALCI) ZDRAVILA, ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJ
English: It induces an active and specific immunity against Muscovy duck parvovirosis and Derzsy's disease in the vaccinated birds.
Slovenian: Cepivo povzroči nastanek aktivne in specifične imunosti proti parvovirozi rac moškatnih bleščavk in Derzsiyevi bolezni pri cepljenih pticah.
English: 2,500 doses
Slovenian: 2.500 odmerkov
English: Gently shake the bag to mix the antigen concentrate with the diluent.
Slovenian: Nežno pretresite vrečko, da zmešate koncentrat antigena in vehikel.
English: The vaccine contains a live attenuated Muscovy duck parvovirus.
Slovenian: Cepivo vsebuje živ atenuiran pravovirus rac moškatnih bleščavk.
English: Insert the trocar provided with the bag of diluent through the closures of both the glass vial and the diluent bag to connect them.
Slovenian: Trokar, ki je priložen vrečki z vehikelom, potisnite skozi pokrovčka obeh, steklene viale in vrečke z vehikelom, da ju povežete.
English: 4.2 Indications for use, specifying the target species Active immunisation of Muscovy ducks to reduce weight loss and lesions of Muscovy duck parvovirosis and Derzsy's disease and, in the absence of maternally derived antibodies, to also prevent mortality.
Slovenian: 4.2 Indikacije za uporabo pri ciljnih živalskih vrstah Aktivna imunizacija rac moškatnih bleščavk za zmanjšanje izgube teže in lezij zaradi parvoviroze rac moškatnih bleščavk in Derzsyjeve bolezni, in za preprečevanje smrtnosti v odsotnosti maternalnih protiteles.
English: MARKETING AUTHORISATION NUMBERS EU/2/14/162/001-002
Slovenian: ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/14/162/001-002
English: PHARMACEUTICAL FORM Concentrate for suspension for injection.
Slovenian: FARMACEVTSKA OBLIKA Koncentrat za suspenzijo za injiciranje
English: MARKETING AUTHORISATION NUMBER(S) EU/2/14/162/001
Slovenian: ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/14/162/001
English: No adverse reactions were observed after the administration of an overdose (10 x the dose).
Slovenian: Po dajanju prevelikega odmerka ni neželenih učinkov (10-kratni odmerek).
English: Lay: Do not use in birds in lay.
Slovenian: Nesnost: Ne uporabite pri pticah v obdobju nesnosti.
English: DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION For subcutaneous use.
Slovenian: ODMERKI ZA POSAMEZNE ŽIVALSKE VRSTE TER POT(I) IN NAČIN UPORABE ZDRAVILA
English: TARGET SPECIES Muscovy ducks.
Slovenian: CILJNE ŽIVALSKE VRSTE Race moškatne bleščavke.
English: Shelf life of the veterinary medicinal product as packaged for sale : 2 years Shelf life after dilution according to directions: 4 hours.
Slovenian: Rok uporabnosti zdravila v pakiranju za prodajo: 2 leti.
English: Live attenuated Muscovy duck parvovirus strain GM 199 .................................... 2.6-4.8 log10 CCID50.
Slovenian: Atenuirani parvovirus rac moškatnih bleščavk, sev GM 199 ................................. 2.6 - 4,8 log10CCID50
English: Live attenuated Muscovy duck parvovirus strain GM 199 ............................... 2.6-4.8 log10 CCID50* * Cell culture infectious dose 50%.
Slovenian: Atenuiran parvovirus rac moškatnih bleščavk, sev GM 199 ............................... 2,6 - 4,8 log10 CCID50* (*) 50% infektivni odmerek za celično kulturo
English: Live attenuated Muscovy duck parvovirus strain GM 199 ...................... 2.6-4.8 log10 CCID50* * Cell culture infectious dose 50%.
Slovenian: Živ atenuiran parvovirus rac moškatnih bleščavk, sev GM 199 ......................... 2,6 - 4,8 log10 CCID50* *50% infektivni odmerek za celično kulturo
English: Active immunisation of Muscovy ducks to reduce weight loss and lesions of Muscovy duck parvovirosis and Derzsy's disease and, in the absence of maternally derived antibodies, to also prevent mortality.
Slovenian: Aktivna imunizacija rac moškatnih bleščavk za zmanjšanje izgube teže in lezij zaradi parvoviroze rac moškatnih bleščavk in Derzsyjeve bolezni, in za preprečevanje smrtnosti v odsotnosti maternalnih protiteles.
English: A small occasional impact on growth cannot be excluded upon vaccination of day-old ducklings free of maternally derived antibodies.
Slovenian: Pri cepljenju 1 dan starih mladičev brez maternalnih protiteles ni mogoče izključiti občasnega majhnega vpliva na rast živali.
English: ATCvet code: QI01BD03.
Slovenian: Farmakoterapevtska skupina: živo virusno cepivo proti račjemu parvovirusu; Oznaka ATC vet: QI01BD03.
English: Shake the vial of antigen concentrate.
Slovenian: Vialo s koncentratom antigena dobro pretresite.
English: PACKAGE SIZE 10 x 500 doses 1x 2,500 doses
Slovenian: VELIKOST PAKIRANJA 10 x 500 odmerkov
English: The entire flock should be vaccinated to lower the risk of any circulation of the vaccine strain and virus recombination.
Slovenian: Za preprečitev kroženja vakcinalnega seva virusa in rekombinacijo virusa, je potrebno cepiti celotno jato.
English: Cardboard box of 1 bag of 2,500 doses.
Slovenian: Škatla z 1 vrečko z 2.500 odmerki.
English: Cardboard box of 10 vials of 500 doses.
Slovenian: Škatla z 10 vialami s 500 odmerki.
English: THE WORDS “KEEP OUT OF THE SIGHT AND REACH OF CHILDREN” Keep out the sight and reach of children.
Slovenian: BESEDILO “ZDRAVILO SHRANJUJTE NEDOSEGLJIVO OTROKOM ” Zdravilo shranjujte nedosegljivo otrokom.
English: Cardboard box of 10 bags of 500 doses.
Slovenian: Škatla 10 vrečkami s 500 odmerki.
English: Cardboard box of 1 vial of 2,500 doses.
Slovenian: Škatla z 1 vialo z 2.500 odmerki.
English: PACKAGE SIZE 500 doses.
Slovenian: VELIKOST PAKIRANJA 500 odmerkov 2.500 odmerkov
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Solvent for Parvoduk concentrate
Slovenian: IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Vehikel za Parvoduk koncentrat za injiciranje
English: Concentrate and solvent for suspension for injection.
Slovenian: Koncentrat in vehikel za suspenzijo za injiciranje.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vials of concentrate
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
English: - First vaccination: at 1 day of age.
Slovenian: - Prvi odmerek: pri 1 dnevu starosti - Drugi odmerek: pri 17 dnevih starosti
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Box of concentrate
Slovenian: PODATKI NA ZUNANJI OVOJNINI IN STIČNI OZ. PRIMARNI OVOJNINI Škatla s koncentratom
English: PHARMACEUTICAL FORM Concentrate and solvent for suspension for injection.
Slovenian: FARMACEVTSKA OBLIKA Koncentrat in vehikel za suspenzijo za injiciranje.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Parvoduk concentrate for suspension for injection for Muscovy ducks
Slovenian: IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Parvoduk koncentrat za suspenzijo za injiciranje za race moškatne bleščavke
English: STATEMENT OF ACTIVE SUBSTANCES Saline buffer
Slovenian: NAVEDBA UČINKOVIN(E) Pufrska raztopina
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Parvoduk solvent for suspension for injection for Muscovy ducks
Slovenian: IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Parvoduk vehikel za suspenzijo za injiciranje za race moškatne bleščavke
English: PACKAGE LEAFLET: Parvoduk concentrate and solvent for suspension for injection for Muscovy ducks
Slovenian: NAVODILO ZA UPORABO Parvoduk koncentrat in vehikel za suspenzijo za injiciranje za race moškatne bleščavke
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Parvoduk concentrate and solvent for suspension for injection for Muscovy ducks
Slovenian: IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Parvoduk koncentrat in vehikel za suspenzijo za injiciranje za race moškatne bleščavke.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Box of solvent
Slovenian: PODATKI NA ZUNANJI OVOJNINI IN STIČNI OZ. PRIMARNI OVOJNINI Škatla z vehiklom
English: Parvoduk
Slovenian: Rp-Vet.
English: --1 Lyophilisate (live attenuated) Canine parainfluenza type 2 virus, strain CPiV-2 Bio 15
Slovenian: Liofilizat (živi atenuirani) Virus pasje parainfluence tipa 2, sev CPiV-2 Bio 15
English: * Tissue culture infectious dose 50%
Slovenian: *50% infektivnega odmerka za tkivno kulturo
English: Package size
Slovenian: Pakiranje Vsebina Velikost pakiranja
English: Date of first authorisation: 23 June 2017
Slovenian: Datum prve odobritve: 23 junij 2017
English: 75011 Paris France
Slovenian: 75011 Pariz
English: No specific interaction studies have been performed.
Slovenian: Posebne raziskave interakcij niso bile opravljene.
English: Frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10) and uncommon (≥1/1,000 to <1/100) 100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data).
Slovenian: Pogostnost neželenih učinkov je opredeljena kot: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10) in občasni (≥ 1/1 000 do < 1/100), redki (≥ 1/10 000 do < 1/1 000), zelo redki (< 1/10 000), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: This leaflet was last revised in {MM/YYYY} Other sources of information
Slovenian: Navodilo je bilo nazadnje revidirano dne <{MM/LLLL}> Drugi viri informacij
English: Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
Slovenian: Obvestite zdravnika ali farmacevta, če uporabljate, ste pred kratkim uporabljali ali pa boste morda začeli uporabljati katero koli zdravilo.
English: • bradycardia (decreased frequency of the heart),
Slovenian: • bradikardija (zmanjšana srčna frekvenca),
English: The effects of Ucedane on pregnancy and the unborn child are not known.
Slovenian: Učinki zdravila Ucedane na nosečnost in na nerojenega otroka niso znani.
English: - if you are allergic to carglumic acid or any of the other ingredients of this medicine (listed in section 6); - during breast-feeding.
Slovenian: - če ste alergični na kargluminsko kislino ali katero koli sestavino tega zdravila (navedeno v poglavju 6); - med dojenjem.
English: What Ucedane is and what it is used for
Slovenian: Kaj je zdravilo Ucedane in za kaj ga uporabljamo
English: Animal studies have revealed minimal developmental toxicity (see section 5.3).
Slovenian: Študije na živalih so razkrile minimalno toksičnost za razvoj (glejte poglavje 5.3).
English: Not known side effects (frequency cannot be estimated from the available data) rash
Slovenian: Neželeni učinki z neznano pogostnostjo (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti) • izpuščaj
English: The tablet can be divided into four equal doses.
Slovenian: Tableto je mogoče razdeliti na štiri enake dele in odmerke.
English: Do not use this medicine after the expiry date which is stated on the blister and carton.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na pretisnem omotu in škatli.
English: The tablets must be dispersed in a minimum of 5 to 10 mL of water and taken immediately.
Slovenian: Tablete je treba raztopiti v najmanj 5 do 10 ml vode in jih nato takoj zaužiti.
English: Ammonia is especially toxic for the brain and leads, in severe cases, to reduced levels of consciousness and to coma.
Slovenian: Amonijak je še posebno toksičen za možgane in lahko v hudih primerih privede do izgube zavesti in kome.
English: Based on pharmacokinetic data and clinical experience, it is recommended to divide the total daily dose into two to four intakes to be given before meals or feedings.
Slovenian: Ob upoštevanju farmakokinetičnih podatkov in kliničnih izkušenj je priporočljivo skupni dnevni odmerek razdeliti v dva do štiri dele, ki se dajejo pred jedjo oziroma hranjenjem.
English: Patients with this rare disorder are not able to eliminate nitrogen waste, which builds up after eating protein.
Slovenian: Bolniki s to redko boleznijo ne morejo izločati odpadnega dušika, ki se kopiči po zaužitju beljakovin.
English: Pharmacotherapeutic group: Amino acids and derivatives; ATC code: A16AA05.
Slovenian: Farmakoterapevtska skupina: aminokisline in njihovi derivati; oznaka ATC: A16AA05.
English: No adverse effects have been observed on male or female fertility.
Slovenian: Opazili niso nobenih neželenih učinkov na plodnost pri moških ali ženskah.
English: It is suggested that depending on its activity, the intestinal bacterial flora may contribute to the initiation of the degradation process, thus leading to a variable extent of metabolism of the molecule.
Slovenian: Domnevajo, da lahko črevesna bakterijska flora odvisno od svoje dejavnosti prispeva k začetku degradacije in s tem povzroči spremenljivost obsega presnove molekule.
English: 1244 RL Ankeveen The Netherlands
Slovenian: 1244 RL Ankeveen v Holandsku
English: Whatever the daily dose, they were slowly declining over 15 hours to levels around 100 ng/mL.
Slovenian: Ne glede na višino dnevnega odmerka so se vrednosti v 15 urah počasi znižale na raven okrog 100 ng/ml.
English: Ucedane treatment should be initiated under the supervision of a physician experienced in the treatment of metabolic disorders.
Slovenian: Zdravljenje z zdravilom Ucedane se sme uvesti le pod nadzorom zdravnika, ki ima izkušnje z zdravljenjem presnovnih bolezni.
English: Plasma levels of carglumic acid were measured in patients of all age categories, from newborn infants to adolescents, treated with various daily doses (7-122 mg/kg/day).
Slovenian: Koncentracije kargluminske kisline v plazmi so merili pri bolnikih vseh starostnih skupin, od novorojenčkov do mladostnikov, ki so jih zdravili z različnimi dnevnimi odmerki (7-122 mg/kg/dan).
English: • increased transaminases (liver enzymes),
Slovenian: • zvišane transaminaze (jetrni encimi),