natgillin/translations-raw huggingface dataset:
On 16 November 2016, Gedeon Richter Plc officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Cavoley, for reducing neutropenia.
Družba Gedeon Richter Plc je 16. novembra 2016 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za pridobitev dovoljenja za promet z zdravilom Cavoley, namenjenim zmanjševanju nevtropenije.
A further study in patients receiving cancer medicines compared the safety and effectiveness of Cavoley and Neulasta.
V drugi študiji pri bolnikih, ki so prejemali zdravila za zdravljenje raka, so primerjali varnost in učinkovitost zdravil Cavoley in Neulasta.
This means that Cavoley was intended to be highly similar to a biological medicine (the ‘reference medicine') already authorised in the European Union called Neulasta.
To pomeni, da naj bi bilo zelo podobno biološkemu zdravilu („referenčnemu zdravilu“), ki je že odobreno v Evropski uniji, in sicer zdravilu Neulasta.
granulocyte-colony-stimulating factor (G-CSF).
beljakovini, imenovani granulocitne kolonije stimulirajoči faktor (G-CSF).
The company informed the CHMP that there are no ongoing clinical trials or compassionate-use programmes for Cavoley.
Družba je odbor CHMP obvestila, da trenutno ne potekajo klinična preskušanja ali programi sočutne uporabe zdravila Cavoley.
Withdrawal of the marketing authorisation application for Cavoley (pegfilgrastim)
Umik vloge za pridobitev dovoljenja za promet z zdravilom Cavoley (pegfilgrastim)
Cavoley was developed as a ‘biosimilar' medicine.
Zdravilo Cavoley je bilo razvito kot „podobno biološko zdravilo“.
How does Cavoley work?
Kako zdravilo Cavoley deluje?
Neutropenia is a side effect of certain cytotoxic (cell-killing) cancer treatments because the treatments also kill white blood cells.
Nevtropenija je neželeni učinek določenih citotoksičnih zdravil za zdravljenje raka (zdravil, ki uničujejo celice), saj ta zdravila uničujejo tudi bele krvne celice.
The company presented results of studies in healthy people designed to show that Cavoley is highly similar to its reference medicine Neulasta in terms of chemical structure, purity, the way it works and how the body handles the medicine.
Družba je predstavila rezultate študij pri zdravih ljudeh, ki naj bi pokazale, da je zdravilo Cavoley po kemijski strukturi, čistosti, načinu delovanja in tem, kako ga telo presnavlja, zelo podobno referenčnemu zdravilu Neulasta.
What was Cavoley expected to be used for?
Za kaj naj bi se zdravilo Cavoley uporabljalo?
What is Cavoley?
Kaj je zdravilo Cavoley?
In its letter notifying the Agency of the withdrawal of the application, the company stated that having considered the CHMP's conclusion, it has decided to withdraw the application but to continue developing the product and follow the CHMP's advice to eliminate the remaining uncertainty.
Družba je v dopisu, s katerim je agencijo obvestila o umiku vloge, navedla, da se je po razmisleku o sklepu odbora CHMP odločila, da bo vlogo umaknila, vendar bo zdravilo razvijala še naprej in upoštevala nasvet odbora, naj razreši obstoječi zadržek.
The active substance in Cavoley, pegfilgrastim, consists of filgrastim that has been 'pegylated' (attached to a chemical called polyethylene glycol).
Zdravilna učinkovina v zdravilu Cavoley, pegfilgrastim, je sestavljena iz filgrastima, ki je bil pegiliran (nanj je bila pritrjena kemična snov, imenovana polietilenglikol).
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).
Cavoley je zdravilo, ki vsebuje zdravilno učinkovino pegfilgrastim, ki spodbuja nastajanje nevtrofilcev (vrste belih krvnih celic, ki se borijo proti okužbam).
Cavoley was to be used in cancer patients to reduce neutropenia (low levels of neutrophils).
Zdravilo Cavoley naj bi se uporabljajo pri bolnikih z rakom za zmanjševanje nevtropenije (nizkih ravni nevtrofilcev).
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.
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.
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.
Zato je odbor CHMP ob umiku vloge menil, da družba ni dokazala, da je zdravilo Cavoley zelo podobno zdravilu Neulasta.
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.
Izrazil je zaskrbljenost, da rezultati študije niso dokazali, da telo zdravilo Cavoley presnavlja na enak način kot referenčno zdravilo Neulasta.
Cavoley was to be used to reduce the duration of neutropenia and the occurrence of febrile neutropenia (neutropenia with fever).
Zdravilo Cavoley naj bi se uporabljalo za skrajšanje nevtropenije ter zmanjšanje pojavljanja febrilne nevtropenije (nevtropenije s povišano telesno temperaturo).
The vaccine is then ready to use.
Cepivo je potem pripravljeno za uporabo.
Then remove the trocar from both containers.
Potem odstranite trokar iz obeh vsebnikov.
Do not use in birds in lay (see section 4.3).
Ne uporabite pri pticah v obdobju nesnosti (glejte poglavje 4.3).
Store and transport refrigerated (2° C - 8° C).
Shranjujte in prevažajte v hladilniku (2 °C - 8 °C).
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.
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.
ANNEX IV GROUNDS FOR ONE ADDITIONAL RENEWAL
PRILOGA IV PODLAGA ZA DODATNO PODALJŠANJE ZA PROMET
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.
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.
b) the disease to which the product is intended to confer immunity is largely absent from the territory in question
b) bolezen, za katero se z zdravilom pridobi imunost, na zadevnem območju skoraj ni prisotna.
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.
C T C G C C C A A T A Cepni sev je lahko v vranici prisoten vsaj 35 dni.
Laboratoire Porte des Alpes Rue de l'Aviation 69800 Saint Priest FRANCE
Laboratoire Porte des Alpes Rue de l'Aviation 69800 Saint Priest Francija
SPECIAL STORAGE CONDITIONS Store below 25° C.
POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte pri temperaturi pod 25° C.
Do not use this veterinary medicinal product after the expiry date which is stated on the carton after EXP.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na ovojnini po EXP.
Casein hydrolysate Aluminium hydroxide
Hidrolizat kazeina Aluminijev hidroksid
Detailed information of this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
Podrobne informacije o tem zdravilu so na voljo na spletni strani Evropske agencije za zdravila (European Medicines Agency) (http://www.ema.europa.eu/.
- Second vaccination: at 17 days of age.
- Drugi odmerek: pri 17 dnevih starosti.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 11/04/2014
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum pridobitve dovoljenja za promet:11/04/2014
After mixing, connect the bag to a high-speed, automated or semi-automated injection system.
Po mešanju povežite vrečko z avtomatskim ali pol-avtomatskim hitrim sistemom za injiciranje.
MANUFACTURER'S BATCH NUMBER Lot
PROIZVAJALČEVA ŠTEVILKA SERIJE Lot
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:
Enajst genetskih markerjev (nukleotidov) na VP1 genu omogoča diferenciacijo Parvoduk cepnega seva od terenskih izolatov parvovirusa rac in gosi, kot je prikazano spodaj:
Goose Parvovirus
Parvovirus gosi
Administer one dose of 0.2 ml by subcutaneous injection according to the following vaccination scheme: - First vaccination: at 1 day of age.
Injicirajte en odmerek (0,2 ml) subkutano po naslednji shemi cepljenja: - Prvi odmerek: pri 1 dnevu starosti.
Manufacturer responsible for batch release: MERIAL
Proizvajalec odgovoren za sproščanje serij: MERIAL
The concentrate is opalescent and homogeneous.
Koncentrat je opalescenten in homogen.
Sodium chloride Potassium chloride Potassium dihydrogen phosphate Disodium phosphate dehydrate Water for injections.
Natrijev klorid Kalijev klorid Kalijev dihidrogenfosfat Dinatrijev fosfat, dehidriran Voda za injekcije
Duration of immunity: 26 days after the primary vaccination course
Trajanje imunosti: do 26 dni po osnovnem cepljenju.
In ducklings free of maternally derived antibodies a single vaccination at day 1 will lead to an onset of immunity after 14 days.
Pri mladičih brez maternalnih protiteles enkratno cepljenje pri 1 dnevu starosti povzroči nastanek imunosti v trajanju 14 dni.
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicine.
Ni podatkov o varnosti ter učinkovitosti ob uporabi tega cepiva s katerim koli drugim zdravilom za uporabo v veterinarski medicini.
Special precaution for use in animals:
Posebni previdnostni ukrepi za uporabo pri živalih:
Name and address of the manufacturer(s) of the biological active substance(s)
Ime in naslov proizvajalca (proizvajalcev) biološke (bioloških) učinkovine (učinkovin)
Onset of immunity: 11 days after the primary vaccination course
Nastop imunosti: 11 dni po osnovnem cepljenju.
Administer one dose of 0.2 ml by subcutaneous injection according to the following vaccination scheme:
Injicirajte en odmerek (0,2 ml) subkutano po naslednji shemi cepljenja:
Overdose (symptoms, emergency procedures, antidotes): No adverse reactions were observed after the administration of an overdose (10x the dose).
Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi): Po dajanju prevelikega odmerka ni neželenih učinkov (10-kratni odmerek).
The demonstrated duration of immunity protects the birds during the period when they are most susceptible to Muscovy duck parvovirosis and Derzsy's disease.
Trajanje imunosti zaščiti ptice v starostnem obdobju, ko so najbolj dovzetne za okužbo s parvovirusom rac moškatnih bleščavk in Derzsyjevo bolezen.
CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES 500 doses
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ODMERKOV 500 odmerkov
Shelf life after dilution according to directions: 4 hours
Rok uporabnosti po razredčenju v skladu z navodili: 4 ure.
Antigen concentrate:
Koncentrat antigena:
Type I glass vials with butyl elastomer closure.
Viala iz stekla tipa I z butil elastomernim pokrovčkom.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS Each reconstituted dose of 0.2 ml contains:
NAVEDBA UČINKOVIN(E) IN DRUGE(IH) SESTAVIN Vsak rekonstituiran odmerek (0,2 ml) vsebuje:
One reconstituted dose of 0.2 ml contains:
En rekonstituiran odmerek (0,2 ml) vsebuje:
Polypropylene bags with butyl elastomer closure and trocar.
Polipropilenske vrečke z butil elastomernim pokrovčkom in trokarjem.
CONTRAINDICATIONS Do not use in birds in lay.
KONTRAINDIKACIJE Ne uporabite pri pticah v obdobju nesnosti.
Transfer the content of the glass vial into the bag of diluent.
Prenesite vsebino viale v vrečko z vehiklom.
Duck Parvovirus
Parvovirus rac
EXP Once diluted, use within 4 hours.
EXP Razredčeno zdravilo uporabite v 4 urah.
QUANTITY OF THE ACTIVE SUBSTANCE(S) Live attenuated Muscovy duck parvovirus.
KOLIČINA UČINKOVIN(E) Živ atenuiran parvovirus rac moškatnih bleščavk.
Once diluted use within 4 hours.
Razredčeno zdravilo uporabite v 4 urah.
A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
A. PROIZVAJALEC (PROIZVAJALCI) BIOLOŠKE (BIOLOŠKIH) UČINKOVINE (UČINKOVIN) IN PROIZVAJALEC (PROIZVAJALCI) ZDRAVILA, ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJ
It induces an active and specific immunity against Muscovy duck parvovirosis and Derzsy's disease in the vaccinated birds.
Cepivo povzroči nastanek aktivne in specifične imunosti proti parvovirozi rac moškatnih bleščavk in Derzsiyevi bolezni pri cepljenih pticah.
2,500 doses
2.500 odmerkov
Gently shake the bag to mix the antigen concentrate with the diluent.
Nežno pretresite vrečko, da zmešate koncentrat antigena in vehikel.
The vaccine contains a live attenuated Muscovy duck parvovirus.
Cepivo vsebuje živ atenuiran pravovirus rac moškatnih bleščavk.
Insert the trocar provided with the bag of diluent through the closures of both the glass vial and the diluent bag to connect them.
Trokar, ki je priložen vrečki z vehikelom, potisnite skozi pokrovčka obeh, steklene viale in vrečke z vehikelom, da ju povežete.
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.
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.
MARKETING AUTHORISATION NUMBERS EU/2/14/162/001-002
ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/14/162/001-002
PHARMACEUTICAL FORM Concentrate for suspension for injection.
FARMACEVTSKA OBLIKA Koncentrat za suspenzijo za injiciranje
MARKETING AUTHORISATION NUMBER(S) EU/2/14/162/001
ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/14/162/001
No adverse reactions were observed after the administration of an overdose (10 x the dose).
Po dajanju prevelikega odmerka ni neželenih učinkov (10-kratni odmerek).
Lay: Do not use in birds in lay.
Nesnost: Ne uporabite pri pticah v obdobju nesnosti.
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION For subcutaneous use.
ODMERKI ZA POSAMEZNE ŽIVALSKE VRSTE TER POT(I) IN NAČIN UPORABE ZDRAVILA
TARGET SPECIES Muscovy ducks.
CILJNE ŽIVALSKE VRSTE Race moškatne bleščavke.
Shelf life of the veterinary medicinal product as packaged for sale : 2 years Shelf life after dilution according to directions: 4 hours.
Rok uporabnosti zdravila v pakiranju za prodajo: 2 leti.
Live attenuated Muscovy duck parvovirus strain GM 199 .................................... 2.6-4.8 log10 CCID50.
Atenuirani parvovirus rac moškatnih bleščavk, sev GM 199 ................................. 2.6 - 4,8 log10CCID50
Live attenuated Muscovy duck parvovirus strain GM 199 ............................... 2.6-4.8 log10 CCID50* * Cell culture infectious dose 50%.
Atenuiran parvovirus rac moškatnih bleščavk, sev GM 199 ............................... 2,6 - 4,8 log10 CCID50* (*) 50% infektivni odmerek za celično kulturo
Live attenuated Muscovy duck parvovirus strain GM 199 ...................... 2.6-4.8 log10 CCID50* * Cell culture infectious dose 50%.
Živ atenuiran parvovirus rac moškatnih bleščavk, sev GM 199 ......................... 2,6 - 4,8 log10 CCID50* *50% infektivni odmerek za celično kulturo
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.
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.
A small occasional impact on growth cannot be excluded upon vaccination of day-old ducklings free of maternally derived antibodies.
Pri cepljenju 1 dan starih mladičev brez maternalnih protiteles ni mogoče izključiti občasnega majhnega vpliva na rast živali.
ATCvet code: QI01BD03.
Farmakoterapevtska skupina: živo virusno cepivo proti račjemu parvovirusu; Oznaka ATC vet: QI01BD03.
Shake the vial of antigen concentrate.
Vialo s koncentratom antigena dobro pretresite.
PACKAGE SIZE 10 x 500 doses 1x 2,500 doses
VELIKOST PAKIRANJA 10 x 500 odmerkov
The entire flock should be vaccinated to lower the risk of any circulation of the vaccine strain and virus recombination.
Za preprečitev kroženja vakcinalnega seva virusa in rekombinacijo virusa, je potrebno cepiti celotno jato.
Cardboard box of 1 bag of 2,500 doses.
Škatla z 1 vrečko z 2.500 odmerki.
Cardboard box of 10 vials of 500 doses.
Škatla z 10 vialami s 500 odmerki.
THE WORDS “KEEP OUT OF THE SIGHT AND REACH OF CHILDREN” Keep out the sight and reach of children.
BESEDILO “ZDRAVILO SHRANJUJTE NEDOSEGLJIVO OTROKOM ” Zdravilo shranjujte nedosegljivo otrokom.
Cardboard box of 10 bags of 500 doses.
Škatla 10 vrečkami s 500 odmerki.
Cardboard box of 1 vial of 2,500 doses.
Škatla z 1 vialo z 2.500 odmerki.
PACKAGE SIZE 500 doses.
VELIKOST PAKIRANJA 500 odmerkov 2.500 odmerkov
NAME OF THE VETERINARY MEDICINAL PRODUCT Solvent for Parvoduk concentrate
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Vehikel za Parvoduk koncentrat za injiciranje
Concentrate and solvent for suspension for injection.
Koncentrat in vehikel za suspenzijo za injiciranje.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vials of concentrate
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
- First vaccination: at 1 day of age.
- Prvi odmerek: pri 1 dnevu starosti - Drugi odmerek: pri 17 dnevih starosti
PARTICULARS TO APPEAR ON THE OUTER PACKAGE Box of concentrate
PODATKI NA ZUNANJI OVOJNINI IN STIČNI OZ. PRIMARNI OVOJNINI Škatla s koncentratom
PHARMACEUTICAL FORM Concentrate and solvent for suspension for injection.
FARMACEVTSKA OBLIKA Koncentrat in vehikel za suspenzijo za injiciranje.
NAME OF THE VETERINARY MEDICINAL PRODUCT Parvoduk concentrate for suspension for injection for Muscovy ducks
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Parvoduk koncentrat za suspenzijo za injiciranje za race moškatne bleščavke
STATEMENT OF ACTIVE SUBSTANCES Saline buffer
NAVEDBA UČINKOVIN(E) Pufrska raztopina
NAME OF THE VETERINARY MEDICINAL PRODUCT Parvoduk solvent for suspension for injection for Muscovy ducks
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Parvoduk vehikel za suspenzijo za injiciranje za race moškatne bleščavke
PACKAGE LEAFLET: Parvoduk concentrate and solvent for suspension for injection for Muscovy ducks
NAVODILO ZA UPORABO Parvoduk koncentrat in vehikel za suspenzijo za injiciranje za race moškatne bleščavke
NAME OF THE VETERINARY MEDICINAL PRODUCT Parvoduk concentrate and solvent for suspension for injection for Muscovy ducks
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Parvoduk koncentrat in vehikel za suspenzijo za injiciranje za race moškatne bleščavke.
PARTICULARS TO APPEAR ON THE OUTER PACKAGE Box of solvent
PODATKI NA ZUNANJI OVOJNINI IN STIČNI OZ. PRIMARNI OVOJNINI Škatla z vehiklom
Parvoduk
Rp-Vet.
--1 Lyophilisate (live attenuated) Canine parainfluenza type 2 virus, strain CPiV-2 Bio 15
Liofilizat (živi atenuirani) Virus pasje parainfluence tipa 2, sev CPiV-2 Bio 15
* Tissue culture infectious dose 50%
*50% infektivnega odmerka za tkivno kulturo
Package size
Pakiranje Vsebina Velikost pakiranja
Date of first authorisation: 23 June 2017
Datum prve odobritve: 23 junij 2017
75011 Paris France
75011 Pariz
No specific interaction studies have been performed.
Posebne raziskave interakcij niso bile opravljene.
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).
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).
This leaflet was last revised in {MM/YYYY} Other sources of information
Navodilo je bilo nazadnje revidirano dne <{MM/LLLL}> Drugi viri informacij
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
Obvestite zdravnika ali farmacevta, če uporabljate, ste pred kratkim uporabljali ali pa boste morda začeli uporabljati katero koli zdravilo.
• bradycardia (decreased frequency of the heart),
• bradikardija (zmanjšana srčna frekvenca),
The effects of Ucedane on pregnancy and the unborn child are not known.
Učinki zdravila Ucedane na nosečnost in na nerojenega otroka niso znani.
- if you are allergic to carglumic acid or any of the other ingredients of this medicine (listed in section 6); - during breast-feeding.
- če ste alergični na kargluminsko kislino ali katero koli sestavino tega zdravila (navedeno v poglavju 6); - med dojenjem.
What Ucedane is and what it is used for
Kaj je zdravilo Ucedane in za kaj ga uporabljamo
Animal studies have revealed minimal developmental toxicity (see section 5.3).
Študije na živalih so razkrile minimalno toksičnost za razvoj (glejte poglavje 5.3).
Not known side effects (frequency cannot be estimated from the available data) rash
Neželeni učinki z neznano pogostnostjo (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti) • izpuščaj
The tablet can be divided into four equal doses.
Tableto je mogoče razdeliti na štiri enake dele in odmerke.
Do not use this medicine after the expiry date which is stated on the blister and carton.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na pretisnem omotu in škatli.
The tablets must be dispersed in a minimum of 5 to 10 mL of water and taken immediately.
Tablete je treba raztopiti v najmanj 5 do 10 ml vode in jih nato takoj zaužiti.
Ammonia is especially toxic for the brain and leads, in severe cases, to reduced levels of consciousness and to coma.
Amonijak je še posebno toksičen za možgane in lahko v hudih primerih privede do izgube zavesti in kome.
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.
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.
Patients with this rare disorder are not able to eliminate nitrogen waste, which builds up after eating protein.
Bolniki s to redko boleznijo ne morejo izločati odpadnega dušika, ki se kopiči po zaužitju beljakovin.
Pharmacotherapeutic group: Amino acids and derivatives; ATC code: A16AA05.
Farmakoterapevtska skupina: aminokisline in njihovi derivati; oznaka ATC: A16AA05.
No adverse effects have been observed on male or female fertility.
Opazili niso nobenih neželenih učinkov na plodnost pri moških ali ženskah.
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.
Domnevajo, da lahko črevesna bakterijska flora odvisno od svoje dejavnosti prispeva k začetku degradacije in s tem povzroči spremenljivost obsega presnove molekule.