FrancophonIA/ELRC3.0 huggingface dataset:
English: On 28 January 2015, the European Medicines Agency completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Tobramycin VVB.
Slovenian: 28. januarja 2015 je Evropska agencija za zdravila končala postopek arbitraže, do katerega je prišlo po nesoglasju med državami članicami Evropske unije (EU) glede odobritve zdravila Tobramycin VVB.
English: This is a procedure where one Member State (the ‘reference Member State', in this instance Lithuania) assesses a medicine with a view to granting a marketing authorisation that will be valid in this country as well as in other Member States (the ‘concerned Member States', in this instance Bulgaria, Estonia, Hungary, Latvia, Poland and Romania).
Slovenian: To je postopek, pri katerem ena država članica („referenčna država članica“, v tem primeru Litva) oceni zdravilo glede tega, ali se zanj lahko odobri dovoljenje za promet, ki bo veljavno v tej državi in drugih državah članicah („zadevnih državah članicah“, v tem primeru v Bolgariji, Estoniji, na Madžarskem, v Latviji, na Poljskem in v Romuniji).
English: EMEA/H/A-29/1428
Slovenian: EMA/55653/2016 rev.1 EMEA/H/A-29/1428
English: However, the Member States were not able to reach an agreement and the Lithuanian medicines regulatory agency referred the matter to the CHMP for arbitration on 14 October 2015.
Slovenian: Vendar države članice niso mogle doseči soglasja, zato je litovska regulativna agencija za zdravila 14. oktobra 2015 zadevo napotila na odbor CHMP v arbitražo.
English: Demonstration of clinical superiority is required because Tobi Podhaler is an orphan medicine and was granted market exclusivity in the EU at the time of its market authorisation in July 2011.
Slovenian: Klinično superiornost je treba dokazati zato, ker je zdravilo Tobi Podhaler zdravilo sirota in mu je bila ob času izdaje dovoljenja za promet julija 2011 dodeljena tržna ekskluzivnost v EU.
English: Why was Tobramycin VVB reviewed?
Slovenian: Zakaj je bilo zdravilo Tobramycin VVB pregledano?
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that Tobramycin VVB can be granted marketing authorisation in Lithuania and in the following Member States of the EU: Bulgaria, Estonia, Hungary, Latvia, Poland and Romania.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da se zdravilu Tobramycin VVB lahko izda dovoljenje za promet v Litvi in naslednjih državah članicah EU: Bolgariji, Estoniji, na Madžarskem, v Latviji, na Poljskem in v Romuniji.
English: Based on the evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that Tobramycin VVB is clinically superior to Tobi Podhaler because a substantial proportion of patients are intolerant to Tobi Podhaler but can be treated with Tobramycin VVB.
Slovenian: Na podlagi ovrednotenja trenutno razpoložljivih podatkov in znanstvene razprave znotraj odbora je odbor CHMP zaključil, da je zdravilo Tobramycin VVB klinično boljše od zdravila Tobi Podhaler, saj znaten delež bolnikov zdravila Tobi Podhaler ne prenaša, lahko pa se zdravijo z zdravilom Tobramycin VVB.
English: UAB VVB submitted Tobramycin VVB to the Lithuanian medicines regulatory agency for a decentralised procedure.
Slovenian: Družba UAB VVB je predložila zdravilo Tobramycin VVB litovski regulativni agenciji za zdravila v decentralizirani postopek.
English: Cystic fibrosis is an inherited disease in which there is an accumulation of thick mucus in the lungs that allows bacteria to grow more easily and cause infections.
Slovenian: Cistična fibroza je dedna bolezen, pri kateri se v pljučih kopiči gosta sluz, ki omogoča lažjo rast bakterij, kar povzroča okužbe.
English: A European Commission decision on this opinion will be issued in due course.
Slovenian: Evropska komisija je sklep v zvezi s tem mnenjem izdala 04. aprila 2016.
English: What is Tobramycin VVB?
Slovenian: Kaj je zdravilo Tobramycin VVB?
English: Tobramycin VVB is an antibiotic for treating long-term lung infection caused by the bacteria Pseudomonas aeruginosa in patients aged 6 years and older who have cystic fibrosis.
Slovenian: Zdravilo Tobramycin VVB je antibiotik, ki se uporablja za zdravljenje dolgotrajne okužbe pljuč z bakterijo Pseudomonas aeruginosa pri bolnikih, starih šest let in več, ki imajo cistično fibrozo.
English: The reason for the referral was a disagreement over whether Tobramycin VVB is clinically superior to Tobi Podhaler, another medicine containing tobramycin.
Slovenian: Razlog za napotitev je bilo nesoglasje o tem, ali je zdravilo Tobramycin VVB klinično boljše od zdravila Tobi Podhaler, drugega zdravila, ki vsebuje tobramicin.
English: The CHMP therefore recommended that Tobramycin VVB be granted marketing authorisation in Lithuania as well as in the other concerned Member States.
Slovenian: Odbor CHMP je zato priporočil, da se zdravilu Tobramycin VVB izda dovoljenja za promet v Litvi in drugih zadevnih državah članicah.
English: It works by disrupting the production of proteins that P. aeruginosa needs to build its cell walls, resulting in damage to the bacteria which eventually kills them.
Slovenian: Deluje tako, da prekine tvorbo beljakovin, ki jih P. aeruginosa potrebuje za gradnjo celičnih sten.
English: Tobramycin VVB is a ‘hybrid medicine' that has been developed to be comparable to a ‘reference medicine' containing tobramycin called Tobi (300 mg/5 ml nebuliser solution).
Slovenian: Zdravilo Tobramycin VVB je „hibridno zdravilo“, ki so ga razvili kot primerljivo „referenčnemu zdravilu“, ki vsebuje tobramicin, imenovanemu Tobi (300 mg/5 ml raztopina za nebulator).
English: Tobramycin VVB is to be available as a nebuliser solution (300 mg/5 ml) to be inhaled.
Slovenian: Zdravilo Tobramycin VVB bo na voljo kot raztopina za nebulator (300 mg/5 ml) za vdihavanje.
English: The active substance in Tobramycin VVB, tobramycin, belongs to the group of antibiotics known as ‘aminoglycosides'.
Slovenian: Zdravilna učinkovina zdravila Tobramycin VVB, tobramicin, spada v skupino antibiotikov, imenovano „aminoglikozidi“.
English: This means that during the period of market exclusivity similar products, such as Tobramycin VVB, cannot be placed on the market; there are, however, exceptions such as where clinically superiority over Tobi Podhaler can be shown.
Slovenian: To pomeni, da v času tržne ekskluzivnosti podobnih zdravil, kot je zdravilo Tobramycin VVB, ni mogoče dati v promet.
English: budesonide / formoterol
Slovenian: budezonid/formoterol
English: The European Commission granted a marketing authorisation valid throughout the European Union for Budesonide/Formoterol Teva Pharma B.V. on 19 November 2014.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Budesonide/Formoterol Teva Pharma B.V., veljavno po vsej Evropski uniji, izdala 19. novembra 2014.
English: This means that it is similar to a ‘reference medicine' containing the same active substances, but Budesonide/Formoterol Teva Pharma B.V. is given using a different inhaler.
Slovenian: To pomeni, da je podobno referenčnemu zdravilu, ki vsebuje isti zdravilni učinkovini, vendar se zdravilo Budesonide/Formoterol Teva Pharma B.V.
English: The full EPAR and risk management plan summary for Budesonide/Formoterol Teva Pharma B.V. can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Studies were carried out to show that Budesonide/Formoterol Teva Pharma B.V. is bioequivalent to the reference medicine (i.e. produces the same level of the active substance in the body) and that the two medicines act in the same way.
Slovenian: biološko enakovredno referenčnemu zdravilu (tj. da dosega enako raven zdravilne učinkovine v telesu) in da obe zdravili enako delujeta.
English: This is a summary of the European public assessment report (EPAR) for Budesonide/Formoterol Teva Pharma B.V.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Budesonide/Formoterol Teva Pharma B.V.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that Budesonide/Formoterol Teva Pharma B.V. 160/4.5 microgram and 320/9 microgram have been shown to have comparable quality and to be equivalent to the corresponding strengths of Symbicort Turbohaler.
Slovenian: v jakostih 160/4,5 mikrograma in 320/9 mikrogramov primerljivo raven kakovosti kot zdravilo Symbicort Turbohaler ter da mu je pri ustrezajočih jakostih biološko enakovredno.
English: What measures are being taken to ensure the safe and effective use of Budesonide/Formoterol Teva Pharma B.V.?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Budesonide/Formoterol Teva Pharma B.V.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Budesonide/Formoterol Teva Pharma B.V., including the appropriate precautions to be followed by healthcare professionals and patients.
Slovenian: V skladu s tem načrtom so bile v povzetek glavnih značilnosti tega zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
English: The two active substances in Budesonide/Formoterol Teva Pharma B.V. are well known and are present in several medicines used to treat asthma, either alone or in combination with other medicines.
Slovenian: sta dobro znani in sta prisotni v več zdravilih, ki se samostojno ali v kombinaciji z drugimi zdravili uporabljajo za zdravljenje astme.
English: What are the benefits and risks of Budesonide/Formoterol Teva Pharma B.V.?
Slovenian: Kakšne so koristi in tveganja, povezani z zdravilom Budesonide/Formoterol Teva Pharma B.V.
English: For more information about treatment with Budesonide/Formoterol Teva Pharma B.V., read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: Other information about Budesonide/Formoterol Teva Pharma B.V.
Slovenian: Druge informacije o zdravilu Budesonide/Formoterol Teva Pharma B.V.
English: The Committee recommended that Budesonide/Formoterol Teva Pharma B.V. be given marketing authorisation.
Slovenian: Priporočil je, da se za zdravilo Budesonide/Formoterol Teva Pharma B.V.
English: A risk management plan has been developed to ensure that Budesonide/Formoterol Teva Pharma B.V. is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila Budesonide/Formoterol Teva Pharma B.V.
English: It is not intended to provide practical advice on how to use Budesonide/Formoterol Teva Pharma B.V.
Slovenian: Za praktične informacije o uporabi zdravila Budesonide/Formoterol Teva Pharma B.V.
English: Why is Budesonide/Formoterol Teva Pharma B.V. approved?
Slovenian: Zakaj je bilo zdravilo Budesonide/Formoterol Teva Pharma B.V.
English: How is Budesonide/Formoterol Teva Pharma B.V. used?
Slovenian: Kako se zdravilo Budesonide/Formoterol Teva Pharma B.V.
English: An additional study was also used to support the main study and to demonstrate the vaccine's safety.
Slovenian: V podporo glavni študiji in za dokazovanje varnosti cepiva je bila izvedena dodatna študija.
English: Adults over 80 years of age may need a double dose of the vaccine (one injection into each shoulder).
Slovenian: Pri odraslih, starejših od 80 let, bo morda potreben dvojni odmerek cepiva (ena injekcija v vsako ramo).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Prepandrix on 14 May 2008.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Prepandrix, veljavno po vsej Evropski uniji, odobrila dne 14. maja 2008.
English: The full EPAR for Prepandrix can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za cepivo Prepandrix je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: For more information about treatment with Prepandrix, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju s cepivom Prepandrix preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: This is a special type of vaccine that is intended to protect against a strain of flu that may cause a future pandemic.
Slovenian: To je posebna vrsta cepiva, namenjena za zaščito proti sevu gripe, ki lahko povzroči prihodnjo pandemijo.
English: There are some data with a vaccine containing a similar H5N1 strain that support the use of half-doses (0.25 ml) in children three to nine years of age.
Slovenian: Nekateri podatki o cepivu, ki vsebuje podoben sev virusa H5N1, podpirajo uporabo polovičnih odmerkov (0,25 ml) pri otrocih, starih od tri do devet let.
English: This is a summary of the European public assessment report (EPAR) for Prepandrix.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Prepandrix.
English: Prepandrix is given by injection into the shoulder or thigh as two 0.5 ml doses, at least three weeks apart.
Slovenian: Prepandrix se daje z injiciranjem v ramensko ali stegensko mišico v dveh 0,5-mililitrskih odmerkih v razmiku najmanj treh tednov.
English: Other information about Prepandrix
Slovenian: Druge informacije o zdravilu Prepandrix
English: Prepandrix must not be given to people who are hypersensitive (allergic) to any of the components of the vaccine, or to any of the substances found at trace (very low) levels in the vaccine, such as eggs, chicken protein, ovalbumin (a protein in egg white), formaldehyde, gentamicin sulphate (an antibiotic) and sodium deoxycholate.
Slovenian: Cepivo Prepandrix se ne sme dajati osebam, ki so preobčutljive za (alergične na) na katero koli sestavino zdravila ali na katero koli od snovi, ki se v sledeh (v zelo nizkih količinah) nahajajo v zdravilu, kot so jajca, piščančje beljakovine, ovalbumin (beljakovina v beljaku), formaldehid, gentamicinijev sulfat (antibiotik) in natrijev deoksiholat.
English: The participants received two injections of Prepandrix 21 days apart.
Slovenian: Sodelujoči so prejeli dve injekciji cepiva Prepandrix v razmiku 21 dni.
English: Prepandrix contains a flu strain called ‘A/Indonesia/05/2005' (H5N1).
Slovenian: Cepivo Prepandrix vsebuje sev gripe, imenovan „A/Indonesia/05/2005“ (H5N1).
English: The emulsion contains an ‘adjuvant' (a compound containing oil) to enhance the immune response.
Slovenian: Cepivo vsebuje tudi „adjuvans“ (spojino, ki vsebuje olje) za povečanje imunskega odziva.
English: Health experts are concerned that a future flu pandemic could be caused by the H5N1 strain of the virus.
Slovenian: Zdravstvene strokovnjake skrbi, da bi lahko naslednjo pandemijo gripe povzročil sev virusa H5N1.
English: The main study showed that Prepandrix containing the adjuvant produced an antibody response that met these criteria.
Slovenian: Glavna študija je pokazala, da cepivo Prepandrix, ki vsebuje adjuvans, sproži odziv protiteles, ki izpolnjuje to merilo.
English: The CHMP decided that Prepandrix's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: CHMP je zaključil, da so koristi cepiva Prepandrix večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
English: The main study of Prepandrix included 675 healthy adults and compared the ability of Prepandrix, with or without the adjuvant, to trigger the production of antibodies (‘immunogenicity').
Slovenian: V glavno študijo cepiva Prepandrix je bilo vključenih 675 zdravih odraslih oseb, primerjali pa so njegovo učinkovitost, z adjuvansom ali brez njega, pri sprožanju tvorbe protiteles („imunogenost“).
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Prepandrix.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Prepandrix, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: At 21 days after the second injection, over 90% of the people receiving the vaccine had levels of antibodies that would protect them against H5N1.
Slovenian: Pri več kot 90 % oseb, ki so prejele cepivo, so bile 21 dni po drugem injiciranju ravni protiteles zadostne, da bi jih zaščitile proti sevu virusa H5N1.
English: According to criteria laid down by the CHMP, a prepandemic vaccine needs to bring about protective levels of antibodies in at least 70% of people for it to be considered suitable.
Slovenian: V skladu z merili, ki jih je določil CHMP, je prepandemično cepivo ustrezno učinkovito le, če zagotovi zaščitno raven protiteles pri vsaj 70 % ljudi.
English: What benefit has Prepandrix shown during the studies?
Slovenian: Kakšne koristi je zdravilo Prepandrix izkazalo med študijami?
English: Prepandrix has been developed to provide protection against this strain, so that it can be used before or during a flu pandemic.
Slovenian: Cepivo Prepandrix je bilo pripravljeno za zaščito proti temu sevu, tako da ga je mogoče uporabiti pred pandemijo gripe ali med njo.
English: Prepandrix is a ‘prepandemic' vaccine.
Slovenian: Zdravilo Prepandrix je „prepandemsko“ cepivo.
English: The most common side effects with Prepandrix (seen in more than 1 patient in 10) are headache, arthralgia (joint pain), myalgia (muscle pain), reactions at the site of the injection (hardening, swelling, pain and redness), fever and fatigue (tiredness).
Slovenian: Najpogostejši neželeni učinki cepiva Prepandrix (opaženi pri več kot 1 bolniku od 10) so glavobol, artralgija (bolečine v sklepih), mialgija (bolečine v mišicah), reakcije na mestu injiciranja (zatrdlina, oteklina, bolečina, rdečina), povišana telesna temperatura in utrujenost.
English: For the full list of all side effects reported with Prepandrix, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi cepiva Prepandrix, glejte navodilo za uporabo.
English: Prepandrix contains small amounts of haemagglutinins (proteins from the surface) of the H5N1 virus.
Slovenian: Cepivo Prepandrix vsebuje majhno količino hemaglutininov (beljakovin s površine) seva virusa H5N1.
English: What is the risk associated with Prepandrix?
Slovenian: Kakšna tveganja so povezana z zdravilom Prepandrix?
English: Prepandrix is a vaccine that is given by injection.
Slovenian: Zdravilo Prepandrix je cepivo za injiciranje.
English: Prepandemic influenza vaccine (H5N1) (split virion, inactivared, adjuvanted)
Slovenian: Povzetek EPAR za javnost prepandemično cepivo proti gripi (H5N1) (z delci virionov, inaktivirano, z adjuvansom)
English: Why has Prepandrix been approved?
Slovenian: Zakaj je bilo zdravilo Prepandrix odobreno?
English: The immune system will then be able to produce antibodies more quickly when it is exposed to the virus again.
Slovenian: Ob ponovni izpostavitvi virusu jih bo tako tvoril hitreje.
English: Prepandrix is a vaccine for use in adults to protect against flu caused by the H5N1 strain (type) of the influenza A virus.
Slovenian: Zdravilo Prepandrix je cepivo, ki se uporablja za cepljenje odraslih proti gripi, ki jo povzroča sev H5N1 virusa gripe A. Cepivo Prepandrix se daje le v skladu z uradnimi priporočili.
English: How has Prepandrix been studied?
Slovenian: Kako je bilo zdravilo Prepandrix raziskano?
English: Vaccination with Prepandrix should be delayed in people who have a severe fever or a sudden infection.
Slovenian: Pri osebah, ki imajo zelo povišano telesno temperaturo ali nenadno okužbo, je treba cepljenje s cepivom Prepandrix odložiti.
English: How does Prepandrix work?
Slovenian: Kako zdravilo Prepandrix deluje?
English: What is Prepandrix used for?
Slovenian: Za kaj se zdravilo Prepandrix uporablja?
English: How is Prepandrix used?
Slovenian: Kako se zdravilo Prepandrix uporablja?
English: What is Prepandrix?
Slovenian: Kaj je zdravilo Prepandrix?
English: - You should not go home unaccompanied.
Slovenian: - Domov ne smete iti brez spremstva.
English: Adequate data is not available.
Slovenian: Na voljo ni ustreznih podatkov.
English: The clinical significance is unknown.
Slovenian: Klinična signifikantnost ni znana.
English: The use in other environments is not recommended.
Slovenian: V drugih okoljih njegova uporaba ni priporočljiva.
English: For hospital use only.
Slovenian: Samo za bolnišnično uporabo.
English: Data on treatment for > 24 hours is not available.
Slovenian: Podatki za zdravljenje > 24 ur niso na voljo.
English: A risk to infants cannot be excluded.
Slovenian: Tveganja za dojenega otroka se ne more izključiti.
English: Under 1 month 1 to < 6 months 6 to < 12 months 12 to < 24 months 2 to < 6 years 6 to < 17 years
Slovenian: Mlajši od 1 meseca 1 do < 6 mesecev 6 do < 12 mesecev 12 do < 24 mesecev 2 do < 6 let 6 do < 17 let
English: - Risk Management Plan (RMP)
Slovenian: • Načrt za obvladovanje tveganja (RMP)
English: The PRAC endorsed this revision.
Slovenian: Odbor PRAC je potrdil to spremembo.
English: Talk to your doctor about the use of these medicines and about the use of alcohol.
Slovenian: Pogovorite se z zdravnikom o uporabi teh zdravil in o uporabi alkohola.
English: Ask your doctor when you can start doing these activities again and when you can go back to this kind of work.
Slovenian: Posvetujte se z zdravnikom, kdaj se lahko ponovno začnete ukvarjati s temi dejavnostmi in kdaj se lahko vrnete na take vrste delo.
English: The available data is summarised in the following table;
Slovenian: Razpoložljivi podatki so povzeti v naslednji preglednici:
English: A dose reduction should be considered.
Slovenian: Premisliti je treba o zmanjšanju odmerka.
English: Your doctor will decide on a suitable dose for you.
Slovenian: Zdravnik bo presodil o primernem odmerku za vas.
English: - The doctor will keep you under medical supervision for some hours after the sedation to make sure that you feel well.
Slovenian: - Zdravnik vas bo še nekaj ur po sedaciji nadzoroval, da bo preveril ali se dobro počutite.
English: Currently available data are described in sections 4.8, 5.1 and 5.2 but no recommendation on a posology can be made.
Slovenian: Podatki, ki so trenutno na voljo, so podani v poglavjih 4.8, 5.1 in 5.2, vendar ni mogoče podati priporočil za odmerjanje zdravila.
English: Please refer to section 4.2.
Slovenian: Prosimo, glejte poglavje 4.2.
English: Supplemental oxygen should be immediately available and provided when indicated.
Slovenian: Dodatni kisik mora biti takoj na voljo in uporabljen, če je to potrebno.
English: Uncontrolled hypotension.
Slovenian: Nenadzorovana hipotenzija.
English: Read all of this leaflet carefully before you are given this medicine because it contains important information for you.
Slovenian: Pred prejemom zdravila natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
English: Data in new-born infants (28
Slovenian: Podatkov za novorojenčke (28.
English: The rate of the maintenance infusion should be adjusted to achieve the targeted level of sedation.
Slovenian: Hitrost vzdrževalne infuzije je treba prilagoditi, da se doseže ciljno stopnjo sedacije.
English: Acute cerebrovascular conditions.
Slovenian: Akutna cerebrovaskularna stanja.
English: The safety and efficacy of Dexdor in children aged 0 to 18 years have not been established.
Slovenian: Pediatrična populacija Varnost in učinkovitost zdravila Dextor pri otrocih, starih 0 do 18 let nista bili dokazani.
English: These effects were associated with clear maternal toxicity.
Slovenian: Ti učinki so bili povezani z očitno toksičnostjo zdravila za samice.