natgillin/translations-raw huggingface dataset:
The pharmacokinetics of carglumic acid has been studied in healthy male volunteers using both radiolabelled and unlabelled product. 
Farmakokinetiko kargluminske kisline so proučevali pri zdravih prostovoljcih moškega spola tako z radioaktivno označenim kot z neoznačenim zdravilom.
Plasma levels of ammonia and amino acids should be maintained within normal limits. 
Plazemske vrednosti amoniaka in aminokislin je treba ohranjati v mejah normalnih vrednosti.
In rats and rabbits no evidence has been seen of embryotoxicity, foetotoxicity or teratogenicity up to maternotoxic doses leading to fifty times exposure as compared to humans in rats and seven times in rabbits. 
Pri podganah in kuncih niso našli nobenih znakov embriotoksičnosti, fetotoksičnosti ali teratogenosti vse do odmerkov, toksičnih za mater, kar je pomenilo pri podganah petdesetkrat, pri kuncih pa sedemkrat večjo izpostavljenost kot pri ljudeh.
If you stop taking Carbaglu Do not stop Carbaglu without informing your doctor. 
Če ste prenehali jemati zdravilo Carbaglu Ne prenehajte jemati zdravila Carbaglu, če niste obvestili svojega zdravnika.
The initial daily dose should be 100 mg/kg, up to 250 mg/kg if necessary. 
Začetni dnevni odmerek naj bo 100 mg/kg pa do 250 mg/kg, če je potrebno.
Your doctor may prescribe supplemental arginine or restrict your protein intake. 
Zdravnik vam lahko predpiše dodatek arginina ali omeji vnos proteinov.
Keep the container tightly closed in order to protect from moisture. 
Vsebnik mora biti tesno zaprt zaradi zaščite pred vlago.
Safety pharmacology studies have shown that Carbaglu administered orally at doses of 250, 500, 1000 mg/kg had no statistically significant effect on respiration, central nervous system and cardiovascular system. 
V študijah farmakološke varnosti niso ugotovili, da bi zdravilo Carbaglu v peroralnih odmerkih po 250, 500 in 1.000 mg/kg imel statistično pomembne učinke na dihala, osrednji živčni sistem in srčnožilni sistem.
After a single oral dose of 100 mg/kg body weight, 9% of the dose is excreted unchanged in the urine and up to 60% in the faeces. 
Po enkratnem peroralnem odmerku 100 mg/kg telesne teže se 9 % odmerka izloči v nespremenjeni obliki v urinu, do 60 % pa v blatu.
At that dose-level, in 12 volunteers given Carbaglu tablets, plasma concentration peaked at 2.6 µg/ml (median; range 1.8-4.8) after 3 hours (median; range 2-4). 
Pri tej velikosti odmerka je koncentracija v plazmi pri 12 prostovoljcih, ki so prejeli zdravilo Carbaglu, dosegla vrh pri 2,6 µg/ml (mediana; območje 1,8-4,8) po 3 urah (mediana; območje 2-4).
Single doses of carglumic acid up to 2800 mg/kg orally and 239 mg/kg intravenously did not induce any mortality or abnormal clinical signs in adult rats. 
Kargluminska kislina v enkratnih odmerkih do 2.800 mg/kg peroralno in 239 mg/kg intravensko pri odraslih podganah ni povzročila smrtnosti ali nenormalnih kliničnih znakov.
In patients with organic acidaemia (neonates and non-neonates), the treatment with carglumic acid induced a quick decrease of ammonia plasma levels, reducing the risk of neurological complications. 
Pri bolnikih z organsko acidemijo (novorojenčki in ne-novorojenčki) je zdravljenje s kargluminsko kislino povzročilo hitro zmanjšanje ravni amonijaka v plazmi ter zmanjšalo tveganje za nevrološke zaplete.
After first opening of the container: do not refrigerate, do not store above 30C. 
Po prvem odprtju vsebnika: Ne shranjujte v hladilniku in pri temperaturi nad 30 C.
Diffusion into erythrocytes is non existent. 
Zdravilo ne difundira v eritrocite.
When the patient is in hyperammonaemic coma, Carbaglu is administered by fast push through a syringe via the tube set up and used to feed you. 
Kadar je bolnik v hiperamonemični komi, se zdravilo Carbaglu daje z naglim izbrizgom iz brizge skozi vstavljeno cevko, po kateri vas hranijo.
Do not take Carbaglu during breast-feeding 
Ne jemljite zdravila Carbaglu med dojenjem.
Uncommon: increased transaminases 
Preiskave občasni: zvišane transaminaze
Do not take Carbaglu: 
Ne jemljite zdravila Carbaglu:
Carbaglu is indicated in treatment of 
Zdravilo Carbaglu je indicirano za zdravljenje
What Carbaglu is and what it is used for Before you take Carbaglu How to take Carbaglu Possible side effects 5 How to store Carbaglu Further information 
Kaj je zdravilo Carbaglu in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Carbaglu Kako jemati zdravilo Carbaglu Možni neželeni učinki
Carbaglu is presented in a plastic container of 5, 15 and 60 tablets which is closed with a child resistant cap. 
Zdravilo Carbaglu je na voljo v plastičnih vsebnikih s po 5, 15 in 60 tabletami, ki so zaprti z za otroke varnim pokrovčkom.
In newborn rats receiving daily carglumic acid by oral gavage for 18 days as well as in young rats receiving daily carglumic acid for 26 weeks, the No Observed Effect Level (NOEL) was established at 500 mg/kg/day and the No Observed Adverse Effect Level (NOAEL) was established at 1000 mg/kg/day. 
Pri novorojenih podganah, ki so prejemale kargluminsko kislino 18 dni po oralni sondi, kot tudi pri mladih podganah, ki so prejemale kargluminsko kislino dnevno skozi 26 tednov, je bila meja ravni brez opaznih učinkov (NOEL - No Observed Effect Level) pri 500 mg/kg/dan, meja brez opaznih neželenih učinkov (NOAEL - No Adverse Effect Level) pa pri 1.000 mg/kg/dan.
Driving and using machines Effects on the ability to drive and use machines are not known. 
Vpliv na sposobnost upravljanja vozil in strojev Vpliv na sposobnost vožnje in upravljanja s stroji ni znan.
Breast-feeding during the use of carglumic acid is contraindicated (see sections 4.6 and 5.3). 
Dojenje je med uporabo kargluminske kisline kontraindicirano (glejte poglavji 4.6 in 5.3).
The tablets must be dispersed in a minimum of 5-10 ml of water and ingested immediately or administered by fast push through a syringe via a nasogastric tube. 
Tablete je treba dispergirati v najmanj 5-10 ml vode in takoj zaužiti, ali aplicirati s hitrim vbrizganjem skozi nazogastrično sondo.
Hyperammonaemia may be due to 
Hiperamoniemija lahko nastane zaradi
Carglumic acid is secreted in the milk of lactating rats and although developmental parameters were unaffected, there were some effects on body weight / body weight gain of pups breast-fed by dams treated with 500 mg/kg/day and a higher mortality of pups from dams treated with 2000 mg/kg/day, a dose that caused maternotoxicity. 
Kargluminska kislina se izloča v mleku doječih podgan in čeprav razvojni parametri niso bili prizadeti, sta se pokazala manjši vpliv na telesno težo / naraščanje telesne teže mladičev, ki so jih dojile samice, ki so prejemale 500 mg/kg/dan, in večja smrtnost mladičev samic, tretiranih z odmerkom 2000 mg/kg/dan, kar je odmerek, ki je povzročil toksičnost za mater.
Uncommon: bradycardia 
Srčne bolezni občasni: bradikardija
EXP {MM/YYYY} Discard 3 months after first opening. 
UPORABNO DO: {MM/LLLL} Zavrzite 3 mesece po prvem odprtju.
After first opening of the tablet container: do not refrigerate, do not store above 30C. 
Po prvem odprtju vsebnika s tabletami: Ne shranjujte v hladilniku in pri temperaturi nad 30 C.
Metabolites are detectable in plasma with a peak at 36-48 hours and a very slow decline (half-life around 100 hours). 
V plazmi lahko najdemo presnovke, katerih koncentracija je najvišja pri 36-48 urah, nato pa se zelo počasi znižuje (razpolovni čas okrog 100 ur).
• For isovaleric acidaemia, methylmalonic acidaemia and propionic acidaemia: The treatment should start upon hyperammonaemia in organic acidaemia patients. 
• Pri izovalerični acidaemiji, metilmalonične acidaemiji in propionske acidaemiji: Zdravljenje je treba uvesti po hiperamoniemiji pri bolnikih z organsko acidemijo.
Carbaglu should ONLY be administered by mouth or via a feeding tube into the stomach (using a syringe, if necessary). 
Zdravilo Carbaglu se sme dajati SAMO peroralno ali prek cevke za hranjenje v želodec (po potrebi z brizgo).
A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE 
A. IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJE
As examples - In a comatose child, start with a dose of 100 to 250 mg/kg/day and measure ammonia plasma concentration at least before each administration; it should normalise within a few hours after starting Carbaglu. 
Primeri: - Pri komatoznih otrocih je treba začeti z odmerkom 100 do 250 mg/kg/dan in preverjati koncentracijo amoniaka v plazmi vsaj pred vsako aplikacijo; vrednosti bi se morale normalizirati nekaj ur po uvedbi zdravljenja z zdravilom Carbaglu.
If you take more Carbaglu than you should Ask your doctor or pharmacist for advice. 
Če ste vzeli večji odmerek zdravila Carbaglu, kot bi smeli Posvetujte se s svojim zdravnikom ali farmacevtom.
Uncommon: diarrhoea, vomiting 
Bolezni prebavil občasni: diareja, bruhanje
After a single oral dose of 100 mg/kg body weight, approximately 30% of carglumic acid is estimated to be absorbed. 
Ocenjujejo, da se po enkratnem peroralnem odmerku 100 mg/kg telesne teže absorbira približno 30 % kargluminske kisline.
In the long term, it may not be necessary to increase the dose according to body weight as long as adequate metabolic control is achieved; daily doses range from 10 mg/kg to 100 mg/kg. 
Pod pogojem, da je doseženo ustrezno obvladovanje presnove, dolgoročno ni nujno povečevati odmerka glede na telesno maso; dnevni odmerki znašajo od 10 mg/kg do 100 mg/kg.
This medicine is for oral use ONLY (ingestion or via a nasogastric tube using a syringe, if necessary). 
To zdravilo je SAMO za peroralno uporabo (zaužitje ali prek nazogastrične sonde, po potrebi z brizgo).
Oral use ONLY Read the package leaflet before use. 
SAMO za peroralno uporabo Pred uporabo preberite priloženo navodilo.
Therefore, breast-feeding during the use of carglumic acid is contraindicated (see section 4.3). 
Zato je dojenje med uporabo kargluminske kisline kontraindicirano (glejte poglavje 4.3).
Carglumic acid is a structural analogue of N-acetylglutamate, which is the naturally occurring activator of carbamoyl phosphate synthetase, the first enzyme of the urea cycle. 
Kargluminska kislina je strukturni analog N-acetilglutamata, ki je naravni vzpodbujevalec karbamoilfosfat-sintetaze, prvega encima ciklusa sečnine
Carglumic acid was shown to decrease blood ammonia levels and increase urea levels in blood and urine, whereas the liver content of carbamoyl phosphate synthetase activators was significantly increased. 
Izkazalo se je, da kargluminska kislina znižuje raven amoniaka v krvi in zvišuje koncentracije sečnine v krvi in urinu, medtem ko je bila prisotnost aktivatorjev karbomoilfosfat-sintetaze v jetrih značilno višja.
One metabolite that has been identified in the faeces is glutamic acid. 
Presnovek, ki so ga identificirali v blatu, je glutaminska kislina.
It should then be individually adjusted in order to maintain normal ammonia plasma levels (see section 4.4). 
Nato ga je treba individualno prilagoditi tako, da se vzdržujejo normalne ravni amonijaka v plazmi (glejte poglavje 4.4).
Do not use after the expiry date stated on the tablet container. 
Zdravila Carbaglu ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na vsebniku s tabletami.
In patients with N-acetylglutamate synthase deficiency, carglumic acid was shown to induce a rapid normalisation of plasma ammonia levels, usually within 24 hours. 
Ugotovili so, da pri bolnikih s pomanjkanjem N-acetilglutamat-sintaze kargluminska kislina povzroči hitro normalizacijo ravni amoniaka v plazmi, običajno že v 24 urah.
What Carbaglu looks like and contents of the pack Carbaglu 200mg tablet is a bar-shaped tablet, with 4 punches on one side with 3 break-mark sides. 
Zdravilo Carbaglu 200 mg tablete ima obliko ploščice s 4 luknjami na eni strani in 3 prelomnimi oznakami na strani.
Occasionally, the use of quarter tablets may also be useful to adjust the posology prescribed by the physician. 
Včasih se za prilagajanje odmerjanja po zdravnikovih navodilih lahko uporablja tudi deljenje tablet na četrtine.
In order to follow-up your condition and your treatment, your doctor may examine your liver, your kidneys, your heart and your blood on a regular basis. 
Zdravnik vam bo mogoče redno pregledoval jetra, ledvici, srce in kri, da bo spremljal vaše zdravstveno stanje in vaše zdravljenje.
Take special care with Carbaglu: 
Bodite posebno pozorni pri jemanju zdravila Carbaglu:
HOW TO TAKE CARBAGLU 
KAKO JEMATI ZDRAVILO CARBAGLU
• Not known: rash 
• neznana: izpuščaj
Pregnancy and Breast-feeding 
Nosečnost in dojenje
This could be explained by the following observations: i) The mitochondrial membrane is more readily permeable for carglumic acid than for Nacetylglutamate ii) Carglumic acid is more resistant than N-acetylglutamate to hydrolysis by aminoacylase present in the cytosol. 
To se da razložiti z naslednjimi ugotovitvami: i) Mitohondrijska membrana je bolj propustna za kargluminsko kislino kot za N-acetilglutamat.
No carcinogenicity study has been conducted with carglumic acid. 
Raziskav kancerogenosti v zvezi s kargluminsko kislino niso izvajali.
- Undesirable effects in N-acetylglutamate synthase deficiency 
- Neželeni učinki pri pomanjkanju N-acetilglutamat-sintaze
Despite a lower affinity of carbamoyl phosphate synthetase for carglumic acid than for N-acetylglutamate, carglumic acid has been shown in vivo to stimulate carbamoyl phosphate synthetase and to be much more effective than N-acetylglutamate in protecting against ammonia intoxication in rats. 
Kljub temu, da ima karbamoilfosfat-sintetaza nižjo afiniteto za kargluminsko kislino kot za Nacetilglutamat, so raziskave in vivo na podganah pokazale, da kargluminska kislina stimulira karbamoilfosfat-sintetazo in v primerjavi z N-acetilglutamatom veliko bolj učinkovito ščiti pred zastrupitvijo z amoniakom.
What Carbaglu contains - The active substance is carglumic acid. 
Kaj vsebuje zdravilo Carbaglu - Zdravilna učinkovina je kargluminska kislina.
The usual dose: the initial daily dose is usually 100 mg per kilogram of body weight, up to a maximum of 250 mg per kilogram of body weight (for example, if you weight 10kg, you should take 1g per day, or 5 tablets), For patients suffering from N-acetylglutamate synthase deficiency, in the long term, the daily dose usually ranges from 10 mg to 100 mg per kilogram of body weight. 
Začetni dnevni odmerek je običajno 100 mg na kilogram telesne mase, do maksimalno 250 mg na kilogram telesne mase (na primer, če tehtate 10 kg, vzemite 1g na dan, kar je 5 tablet).
Each tablet contains 200 mg of carglumic acid. 
Vsaka tableta vsebuje 200 mg kargluminske kisline.
• For N-acetylglutamate synthase deficiency: 
• Pri pomanjkanju N-acetilglutamat-sintaze:
• isovaleric acidaemia, methylmalonic acidaemia or propionic acidaemia. 
• izovalerične acidemije, metilmalonične acidemije ali propionske acidemije.
No studies on the effects on the ability to drive and use machines have been performed. 
Vpliva na sposobnost vožnje in upravljanja s stroji niso raziskovali.
Carglumic acid has been shown in vitro to activate liver carbamoyl phosphate synthetase. 
Raziskave in vitro so pokazale, da kargluminska kislina aktivira karbomoilfosfat-sintetazo v jetrih.
60 dispersible tablets 
60 disperzibilnih tablet
Please consult your doctor for advice if you are pregnant or planning to become pregnant. 
Če ste noseči ali če načrtujete zanositev, prosite za nasvet svojega zdravnika.
Carglumic acid responsiveness test It is recommended to test individual responsiveness to carglumic acid before initiating any long term treatment. 
Pred uvedbo dolgotrajnega zdravljenja je priporočljivo individualno testiranje odgovora na kargluminsko kislino.
- In a patient with moderate hyperammonaemia, administer a test dose of 100 to 200 mg/kg/day for 3 days with a constant protein intake and perform repeated determinations of ammonia plasma concentration (before and 1 hour after a meal); adjust the dose in order to maintain normal ammonia plasma levels. 
200 mg/kg/dan ob stalnem vnosu proteinov; preverjanje koncentracij amoniaka v plazmi se ponavlja (pred jedjo in 1 uro po jedi); za vzdrževanje normalnih ravni amoniaka v plazmi se odmerek ustrezno prilagaja.
The breaking of the tablets in halves allows most of the required posology adjustments. 
Z razpolavljanjem tablet se običajno da doseči zahtevano prilagoditev odmerka.
Carbaglu 200 mg dispersible tablets 
Carbaglu 200 mg disperzibilne tablete
2.2 Qualitative and quantitative composition For a full list of excipients, see section 6.1 
Za celoten seznam pomožnih snovi glejte poglavje 6.1.
• hyperammonaemia due to N-acetylglutamate synthase primary deficiency. 
• hiperamoniemije, ki je posledica primarnega pomanjkanja N-acetilglutamat-sintaze;
Microcrystalline cellulose sodium laurilsulfate hypromellose croscarmellose sodium silica colloidal anhydrous sodium stearyl fumarate 
6.1 Seznam pomožnih snovi mikrokristalna celuloza natrijev lavrilsulfat hipromeloza premreženi natrijev karmelozat brezvodni koloidni silicijev dioksid natrijev stearilfumarat
Carbaglu must be taken orally before meals or feedings. 
Jemanje zdravila Carbaglu skupaj s hrano in pijačo Zdravilo Carbaglu morate jemati peroralno pred obrokom hrane ali hranjenjem.
OUTER CARTON BOX AND TABLET CONTAINER LABEL X 60 TABLETS 
ZUNANJA KARTONSKA ŠKATLA IN NALEPKA NA VSEBNIKU ZA TABLETE X 60 TABLET
5 dispersible tablets 
5 disperzibilnih tablet
HOW TO STORE CARBAGLU 
SHRANJEVANJE ZDRAVILA CARBAGLU
OUTER CARTON BOX AND TABLET CONTAINER LABEL X 5 TABLETS 
ZUNANJA KARTONSKA ŠKATLA IN NALEPKA NA VSEBNIKU ZA TABLETE X 5 TABLET
• the lack of a specific liver enzyme N- acetylglutamate synthase. 
• pomanjkanja določenega jetrnega encima, N-acetilglutamat-sintaze.
5-, 15- or 60- high density polyethylene tablet containers closed by a child resistant polypropylene cap with a desiccant unit. 
Vsebnik iz polietilena visoke gostote s 5, 15 ali 60 tabletami, zaprt z za otroke varnim polipropilenskim pokrovčkom s sušilnim sredstvom.
Write the date of opening on the tablet container. 
Na vsebnik s tabletami napišite datum, kdaj ste ga prvič odprli.
Nutritional management Protein restriction and arginine supplementation may be indicated in case of low protein tolerance. 
Uravnavanje s prehrano Pri slabem prenašanju proteinov je lahko umestno omejevanje vnosa proteinov in dodajanje arginina.
15 dispersible tablets 
15 disperzibilnih tablet
OUTER CARTON BOX AND TABLET CONTAINER LABEL X 15 TABLETS 
ZUNANJA KARTONSKA ŠKATLA IN NALEPKA NA VSEBNIKU ZA TABLETE X 15 TABLET
• hyperammonaemia due to propionic acidaemia. 
• hiperamoniemije zaradi propionske acidemije.
It should then be adjusted individually in order to maintain normal ammonia plasma levels (see section 4.4). 
Za vzdrževanje normalne ravni amoniaka v plazmi je treba nato odmerek individualno prilagajati (glejte poglavje 4.4).
Carbaglu 200 mg dispesible tablets Carglumic acid 
Carbaglu 200 mg disperzibilne tablete kargluminska kislina
- The other ingredients are microcrystalline cellulose, sodium laurilsulfate, hypromellose, 
- Pomožne snovi so mikrokristalna celuloza, natrijev lavrilsulfat, hipromeloza, natrijeva kroskarmeloza, brezvodni koloidni silikagel, natrijev stearilfumarat.
• hyperammonaemia due to methymalonic acidaemia. 
• hiperamoniemije zaradi metilmalonične acidemije;
Nevertheless, as carglumic acid has been shown to be present in the milk of lactating rats with potential toxic effects for their fed pups, you should not breast feed your baby if you are taking Carbaglu. 
Vendar ne smete dojiti svojega otroka, če jemljete zdravilo Carbaglu, ker so v mleku doječih podgan dokazali kargluminsko kislino, ki ima lahko toksične učinke za njihove dojene mladiče.
The dose should be individually adjusted in order to maintain normal ammonia plasma levels. 
Za vzdrževanje normalne ravni amoniaka v plazmi je treba odmerek individualno prilagajati.
Your doctor will evaluate your individual responsiveness to carglumic acid before initiating any long term treatment. 
Pred uvedbo dolgotrajnega zdravljenja bo zdravnik ocenil, kakšen je vaš individualni odgovor na kargluminsko kislino.
Always take Carbaglu exactly as your doctor has instructed you. 
Pri jemanju zdravila Carbaglu natančno upoštevajte zdravnikova navodila.
Marketing Authorisation Holder Recordati Rare Diseases Immeuble “Le Wilson” 70, avenue du Général de Gaulle F-92800 Puteaux 
Imetnik dovoljenja za promet z zdravilom Recordati Rare Diseases Immeuble “Le Wilson” 70, Avenue du Général de Gaulle F-92800 Puteaux
Common: increased sweating Not known: rash 
Bolezni kože in podkožja pogosti: zvečano znojenje neznana: izpuščaj
Recordati Rare Diseases Immeuble “Le Wilson” 70, avenue du Général de Gaulle F-92800 Puteaux France 
Recordati Rare Diseases Immeuble “Le Wilson” 70, Avenue du Général de Gaulle F-92800 Puteaux Francija
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu. 
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu/, kjer lahko najdete tudi povezave do drugih spletnih strani o redkih boleznih in zdravljenju.
Recordati Rare Diseases Immeuble ‘Le Wilson' 70, avenue du Général de Gaulle F-92800 Puteaux France or 
Recordati Rare Diseases Immeuble ‘Le Wilson' 70, Avenue du Général de Gaulle F-92800 Puteaux Francija ali
Skin and subcutaneous tissue disorders 
Bolezni kože in podkožja neznana: izpuščaj
Dispersible tablet 
Disperzibilne tablete
BEFORE YOU TAKE CARBAGLU 
KAJ MORATE VEDETI, PREDEN BOSTE VZELI ZDRAVILO CARBAGLU
Carbaglu showed no significant mutagenic activity in a battery of genotoxicity tests performed in vitro (Ames test, human lymphocyte metaphase analysis) and in vivo (micronucleus test in rat). 
S serijo genotoksičnih testov in vitro (Amesov test, analiza metafaze humanih limfocitov) kot tudi in vivo (mikrojedrni test pri podganah) niso ugotovili, da bi zdravilo Carbaglu imel pomembne mutagene učinke.
Uncommon: pyrexia 
Splošne težave in spremembe na mestu aplikacije občasni: pireksija
• hyperammonaemia due to isovaleric acidaemia. 
• hiperamoniemije zaradi izovalerične acidemije;
Opened: 
Odprto dne:
A proportion of carglumic acid is metabolised. 
Nekaj kargluminske kisline se presnovi.
The European Commission issued a decision on 6 August 2009. 
Evropska komisija je odločbo izdala 6. avgusta 2009.
Article 29 of Directive 2001/83/EC as amended, referral on the grounds of potential serious risk to public health 
Člen 29 Direktive 2001/83/ES, kakor je bila spremenjena, napotitev na podlagi možnega resnega tveganja za javno zdravje.
The Committee noted that this product was previously authorised in a number of other Member States on the basis of the same data. 
Odbor je poudaril, da je bilo to zdravilo predhodno odobreno v številnih drugih državah članicah na podlagi istih podatkov.
London, 17 August 2009 Doc. 
London, 17. avgusta 2009 Sklic dok.
Ref. EMEA/CHMP/563259/2009 EMEA/H/A-29/1060 
: EMEA/CHMP/559837/2009 EMEA/H/A-29/1060
These countries are Austria, Denmark, Finland, Germany, Greece, Norway, Portugal, Spain, Sweden and the United Kingdom. 
Te države so Avstrija, Danska, Finska, Nemčija, Grčija, Norveška, Portugalska, Španija, Švedska in Združeno kraljestvo.
The review was carried out under an ‘Article 29' referral1. 
Pregled je bil izveden v skladu z napotitvenim postopkom iz „člena 29“1.
Dr Pieter Neels (Belgium) 
dr. Pieter Neels (Belgija)
Prof. Michal Pirożynski (Poland) 
prof. Michal Pirożynski (Poljska)
The company wanted the authorisation to be recognised in Bulgaria, the Czech Republic, Estonia, France, Hungary, Italy, Latvia, Lithuania, Poland, Romania, Slovenia and Slovakia (the ‘concerned Member States'). 
Družba je želela, da se odobritev prizna v Bolgariji, Češki republiki, Estoniji, Franciji, Madžarski, Italiji, Latviji, Litvi, Poljski, Romuniji, Sloveniji in na Slovaškem („zadevnih državah članicah“).
29 May 2009 
29. maj 2009
This means that it is similar to a ‘reference medicine' already authorised in the EU called Clarityne. 
To pomeni, da je podobno „referenčnemu zdravilu“ z imenom Clarityne, ki je že odobreno v Evropski uniji (EU).
Loratadine is an antihistamine. 
Loratadin je antihistaminik.
‘Idiopathic' means that the cause of the urticaria is not known. 
Izraz „idiopatska“ pomeni, da vzrok urtikarije ni znan.