natgillin/translations-raw huggingface dataset:
- Each vial of Atosiban SUN 37.5 mg/5 ml concentrate for solution for infusion contains atosiban acetate equivalent to 37.5 mg of atosiban in 5 ml. 
- Ena viala zdravila Atoziban SUN 37,5 mg/5 ml koncentrat za raztopino za injiciranje vsebuje atozibanijev acetat, ki ustreza 37,5 mg atozibana v 5 ml.
30 weeks of your pregnancy or more. 
- Če vam je odtekla voda (predčasni razpok plodovega mehurja), noseči pa ste že 30 tednov ali dlje.
This is done by removing 10 ml of solution from a 100 ml infusion bag and replacing it with 10 ml Atosiban SUN 37.5 mg/5 ml concentrate for solution for infusion from two 5 ml vials to obtain a concentration of 75 mg atosiban in 100 ml. 
Iz 100 ml infuzijske vrečke odstranite 10 ml raztopine in jo nadomestite z 10 ml zdravila Atobisan SUN 37,5 mg/5 ml koncentrat za raztopino za infundiranje iz dveh 5 ml vial, da dobite koncentracijo 75 mg atozibana na 100 ml.
What Atosiban SUN contains - The active substance is atosiban. 
Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Atoziban SUN - Učinkovina je atoziban.
fluid retention and/or protein in your urine. 
Za hudo preeklampsijo (nosečnostna toksemija) so značilni zelo visok krvni tlak, zastajanje tekočin in/ali prisotnost beljakovin v urinu.
For storage conditions after first opening of the medicinal product, see section 6.3. 
Za pogoje shranjevanja po prvem odprtju zdravila glejte poglavje 6.3. 6.5 Vrsta ovojnine in vsebina
Patients with renal or liver impairment 
Bolnice z okvaro ledvic ali jeter
Name and address of the manufacturer(s) responsible for batch release Sun Pharmaceutical Industries Europe B.V. 
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Sun Pharmaceutical Industries Europe B.V.
Atosiban must not be used in the following conditions: - Gestational age below 24 or over 33 completed weeks - Premature rupture of the membranes >30 weeks of gestation - Abnormal foetal heart rate - Antepartum uterine haemorrhage requiring immediate delivery - Eclampsia and severe pre-eclampsia requiring delivery - Intrauterine foetal death - Suspected intrauterine infection - Placenta praevia - Abruptio placenta - Any other conditions of the mother or foetus, in which continuation of pregnancy is hazardous - Hypersensitivity to the active substance or any of the excipients listed in section 6.1. 
Atozibana se ne sme uporabljati v naslednjih primerih: - gestacijska starost pod 24 ali nad 33 dopolnjenih tednov, - prezgoden razpok plodnega mehurja > 30 tednov gestacije, - nenormalna srčna frekvenca ploda, - predporodna maternična krvavitev, ki zahteva takojšen porod, - eklampsija ali huda preeklampsija, ki zahtevata porod,
- If your unborn baby has died. 
- Če je plod odmrl.
- Gestational age below 24 or over 33 completed weeks - Premature rupture of the membranes >30 weeks of gestation - Abnormal foetal heart rate - Antepartum uterine haemorrhage requiring immediate delivery - Eclampsia and severe pre-eclampsia requiring delivery - Intrauterine foetal death - Suspected intrauterine infection - Placenta praevia - Abruptio placenta - Any other conditions of the mother or foetus, in which continuation of pregnancy is hazardous - Hypersensitivity to the active substance or any of the excipients listed in section 6.1. 
- gestacijska starost pod 24 ali nad 33 dopolnjenih tednov, - prezgoden razpok plodnega mehurja > 30 tednov gestacije, - nenormalna srčna frekvenca ploda, - predporodna maternična krvavitev, ki zahteva takojšen porod, - eklampsija ali huda preeklampsija, ki zahtevata porod,
Once the vial has been opened, the medicinal product must be used straight away. 
Zdravilo je treba uporabiti takoj po odprtju viale.
France tel. +33 1 41 44 44 50 
92800 Puteaux France tel. +33 1 41 44 44 50 Italia
What Atosiban SUN looks like and contents of the pack Atosiban SUN 6.75 mg/0.9 ml solution for injection is a clear, colourless solution without particles. 
Zdravilo Atoziban SUN 6,75 mg/0,9 ml raztopina za injiciranje je bistra, brezbarvna raztopina brez delcev.
Each ml of solution contains 7.5 mg atosiban. 
En mililiter raztopine vsebuje 7,5 mg atozibana.
Atosiban SUN is given intravenously in three successive stages: - The initial intravenous injection of 6.75 mg in 0.9 ml is slowly injected into a vein over one minute. 
Zdravilo Atoziban SUN aplicirajte intravensko v treh zaporednih korakih: - Začetna intravenska injekcija 6,75 mg v 0,9 ml. Injicirajte počasi (tj. eno minuto) v veno.
- Your womb may be less able to contract after your baby has been born. 
- Po porodu se lahko zmanjša sposobnost maternice za skrčitev.
- Rash. 
- Srbenje.
There is no experience with atosiban treatment in patients with impaired function of the liver or kidneys. 
Pri bolnicah z okvaro delovanja jeter ali ledvic ni izkušenj z uporabo atozibana.
PHARMACEUTICAL FORM AND CONTENTS Solution for injection 
FARMACEVTSKA OBLIKA IN VSEBINA koncentrat za raztopino za infundiranje.
- Hot flushes. 
- Navali vročine.
Atosiban does not partition into red blood cells. 
Atoziban se ne porazdeli v eritrocite.
Atosiban SUN will be given into a vein (intravenously) in three stages: - The first injection of 6.75 mg in 0.9 ml will be slowly injected into your vein over one minute. 
Zdravilo Atoziban SUN boste prejeli v veno (intravensko) v treh korakih: - Najprej boste v veno prejeli počasno injekcijo s 6,75 mg v 0,9 ml. Injiciranje zdravila bo trajalo eno minuto.
Atosiban SUN contains atosiban. 
Atoziban SUN.
Hydrochloric acid 1M 
1M klorovodikova kislina voda za injekcije
- Itching. 
(uterusa).
If you are not sure, talk to your doctor, midwife or pharmacist before you are given Atosiban SUN. 
Če ste negotovi, se posvetujte s svojim zdravnikom, z babico ali farmacevtom, preden prejmete zdravilo
Patients with renal or hepatic impairment 
Posebne skupine bolnikov Bolnice z okvaro ledvic ali jeter
24 hours after preparation. 
Infundiranje traja 3 ure.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 0.9 ml (6.75 mg/0.9 ml) 
0,9 ml (6,75 mg/0,9 ml)
Atosiban is administered intravenously in three successive stages: an initial bolus dose (6.75 mg), performed with atosiban 6.75 mg/0.9 ml solution for injection, immediately followed by a continuous high dose infusion (loading infusion 300 micrograms/min) of atosiban 37.5 mg/5 ml concentrate for solution for infusion during three hours, followed by a lower dose of atosiban 37.5 mg/5 ml concentrate for solution for infusion (subsequent infusion 100 micrograms/min) up to 45 hours. 
(polnilna infuzija 300 mikrogramov/min) atozibana 37,5 mg/5 ml koncentrat za raztopino za infundiranje, ki traja tri ure, in nato še infuzija z manjšim odmerkom atozibana 37,5 mg/5 ml koncentrat za raztopino za infundiranje (nadaljnja infuzija 100 mikrogramov/min), ki traja do 45 ur.
Atosiban SUN 37.5 mg/5 ml concentrate for solution for infusion atosiban 
Atoziban SUN 37,5 mg/5 ml koncentrat za raztopino za infundiranje atoziban
NAME OF THE MEDICINAL PRODUCT Atosiban SUN 37.5 mg/5 ml concentrate for solution for infusion atosiban 
IME ZDRAVILA Atoziban SUN 37,5 mg/5 ml koncentrat za raztopino za infundiranje atoziban
NAME OF THE MEDICINAL PRODUCT Atosiban SUN 37.5 mg/5 ml concentrate for solution for infusion 
IME ZDRAVILA Atoziban SUN 37,5 mg/5 ml koncentrat za raztopino za infundiranje
STATEMENT OF ACTIVE SUBSTANCE(S) Each vial of 0.9 ml solution contains 6.75 mg of atosiban (as acetate). 
Ena viala z 0,9 ml raztopine vsebuje 6,75 mg atozibana (v obliki acetata).
QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial of 0.9 ml solution contains 6.75 mg atosiban (as acetate). 
Ena viala s 0,9 ml raztopine vsebuje 6,75 mg atozibana (v obliki acetata).
QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial of 5 ml solution contains 37.5 mg atosiban (as acetate). 
Ena viala s 5 ml raztopine vsebuje 37,5 mg atozibana (v obliki acetata).
STATEMENT OF ACTIVE SUBSTANCE(S) Each vial of 5 ml solution contains 37.5 mg of atosiban (as acetate). 
Ena viala z 5 ml raztopine vsebuje 37,5 mg atozibana (v obliki acetata).
Not relevant. 
Podatek ni potreben
Atosiban SUN 6.75 mg/0.9 ml solution for injection atosiban 
Atoziban SUN 6,75 mg/0,9 ml raztopina za injiciranje atoziban
Further treatment cycles of Atosiban SUN can be used should contractions recur. 
Če se kontrakcije uterusa ponovijo, se lahko cikel zdravljenja z zdravilom Atoziban SUN ponovi.
Uterine haemorrhage, uterine atony 
Hitrost infundiranja Odmerek atozibana
Do not use Atosiban SUN if any of the above apply to you. 
Če kar koli od zgoraj naštetega velja za vas, zdravila Atoziban SUN ne smete uporabljati.
MedDRA system organ class (SOC) 
Razvrstitev organskih sistemov po MedDRA
Provides 0.75 mg/ml when diluted as recommended. 
Po priporočenem redčenju vsebuje 0,75 mg/ml
0.9 ml intravenous bolus 
0,9 ml intravenski bolus injekcija dana po 1 minuti
- Feeling dizzy. 
- Omotica.
NAME OF THE MEDICINAL PRODUCT Atosiban SUN 6.75 mg/0.9 ml solution for injection 
Atoziban SUN 6,75 mg/0,9 ml raztopina za injiciranje
6.1 List of excipients 
FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi manitol
Contents of the pack and other information 
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT
Insomnia 
Dojenje
Batch 
Viala
Hyperglycaemia 
Cluj-Napoca, Judeţul Cluj
NAME OF THE MEDICINAL PRODUCT Atosiban SUN 6.75 mg/0.9 ml solution for injection atosiban 
Navodilo za uporabo Atoziban SUN 6,75 mg/0,9 ml raztopina za injiciranje atoziban
They will also make sure the solution is clear and free from particles. 
Oseba, ki vam bo zdravilo aplicirala, bo najprej preverila, če je raztopina bistra in ne vsebuje trdnih delcev.
How Atosiban SUN will be given 
Kako vam bo zdravilo Atoziban SUN dano
It is available as orodispersible tablets (5, 10, 15 and 20 mg). 
Na voljo je v obliki orodisperzibilnih tablet (5, 10, 15 in 20 mg).
It is known as an ‘atypical' antipsychotic because it is different from the older antipsychotic medicines that have been available since the 1950s. 
Spada med netipična antipsihotična zdravila, ker se razlikuje od starejših antipsihotikov, ki so na voljo od petdesetih let prejšnjega stoletja.
It can also be used to prevent the recurrence of these episodes (when symptoms come back) in adults with bipolar disorder (a mental illness with alternating periods of high mood and depression) who have responded to an initial course of treatment. 
Uporablja se lahko tudi za preprečevanje ponovnega pojava simptomov teh epizod pri odraslih z bipolarno motnjo (duševno boleznijo, pri kateri se izmenjujejo obdobja privzdignjenega razpoloženja in depresije), ki so se odzvali na začetno zdravljenje.
Its exact mechanism of action is unknown, but it attaches to several different receptors on the surface of nerve cells in the brain. 
Natančen mehanizem delovanja zdravila sicer ni znan, vendar se zdravilo veže na več različnih receptorjev na površini živčnih celic v možganih.
Schizophrenia is a mental illness that has a number of symptoms, including disorganised thinking and speech, hallucinations (hearing or seeing things that are not there), suspiciousness and delusions (mistaken beliefs). 
To je duševna bolezen s številnimi simptomi, kot so neorganizirano mišljenje in govor, halucinacije (prisluhi ali prividi), sumničavost ter blodnje (zmotna prepričanja).
The full EPAR for the reference medicines can also be found on the Agency's website. 
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za referenčno zdravilo je prav tako na voljo na spletni strani agencije.
The full EPAR for Olanzapine Glenmark Europe can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Olanzapine Glenmark Europe je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The recommended starting dose of Olanzapine Glenmark Europe depends on the disease being treated: 10 mg per day is used in schizophrenia and in the prevention of manic episodes, and 15 mg per day in the treatment of manic episodes, unless it is used with other medicines, in which case the starting dose can be 10 mg per day. 
Priporočeni začetni odmerek zdravila Olanzapine Glenmark Europe je odvisen od bolezni, ki jo zdravimo: pri shizofreniji in za preprečevanje maničnih epizod se uporablja 10-miligramski odmerek na dan, pri zdravljenju maničnih epizod pa se uporablja 15-miligramski odmerek na dan, razen ob souporabi drugih zdravil, ko lahko začetni odmerek znaša 10 mg na dan. Odmerek se prilagodi glede na to, kako se bolnik odziva na zdravljenje in kako ga prenaša.
For more information about treatment with Olanzapine Glenmark Europe, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Olanzapine Glenmark Europe preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Olanzapine Glenmark Europe is also effective in maintaining improvement in patients who have responded to an initial course of treatment. 
Zdravilo Olanzapine Glenmark Europe je prav tako učinkovito za vzdrževanje izboljšanja stanja pri bolnikih, ki so se odzvali na začetno zdravljenje.
This is a summary of the European public assessment report (EPAR) for Olanzapine Glenmark Europe. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Olanzapine Glenmark Europe.
Olanzapine Glenmark Europe is also used to treat moderate to severe manic episodes (extremely high mood) in adults. 
Zdravilo Olanzapine Glenmark Europe se uporablja tudi za zdravljenje zmernih do težkih maničnih epizod (izjemno privzdignjeno razpoloženje) pri odraslih.
The European Commission granted a marketing authorisation valid throughout the EU for Olanzapine Glenmark Europe on 3 December 2009. 
Evropska komisija je dovoljenje za promet z zdravilom Olanzapine Glenmark Europe, veljavno po vsej Evropski uniji, izdala 3. decembra 2009.
Because Olanzapine Glenmark Europe is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as the reference medicines. 
Ker je zdravilo Olanzapine Glenmark Europe generično zdravilo in je biološko enakovredno referenčnima zdraviloma, so koristi in tveganja enaki kot pri referenčnih zdravilih.
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 Olanzapine Glenmark Europe. 
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
This means that Olanzapine Glenmark Europe is similar to ‘reference medicines' already authorised in the European Union (EU) called Zyprexa and Zyprexa Velotabs. 
To pomeni, da je podobno „referenčnima zdraviloma“, ki sta že odobreni v Evropski uniji (EU), in sicer zdraviloma Zyprexa in Zyprexa Velotab.
The CHMP concluded that, in accordance with EU requirements, Olanzapine Glenmark Europe has been shown to have comparable quality and to be bioequivalent to Zyprexa and Zyprexa Velotab. 
CHMP je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Olanzapine Glenmark Europe primerljivo raven kakovosti kot zdravili Zyprexa in Zyprexa Velotab ter da jima je biološko enakovredno.
Because Olanzapine Glenmark Europe is a generic medicine, studies have been limited to tests to determine that it is bioequivalent to the reference medicines, Zyprexa and Zyprexa Velotab. 
Ker je zdravilo Olanzapine Glenmark Europe generično zdravilo, so bile študije omejene na preskuse, s katerimi se dokazuje, da je biološko enakovredno referenčnima zdraviloma Zyprexa in Zyprexa Velotab.
Olanzapine Glenmark Europe is a ‘generic medicine'. 
Olanzapine Glenmark Europe je „generično zdravilo“.
The orodispersible tablets are taken by being placed on the tongue, where they disintegrate in the saliva, or by mixing them in water before swallowing. 
Običajni razpon odmerkov je od 5 do 20 mg na dan. Orodisperzibilne tablete se zaužijejo tako, da se položijo na jezik, kjer jih slina raztopi, ali tako, da se pred zaužitjem zmešajo z vodo.
The Committee recommended that Olanzapine Glenmark Europe be given marketing authorisation. 
Odbor je priporočil, da se za zdravilo Olanzapine Glenmark Europe izda dovoljenje za promet.
What are the benefits and risks of Olanzapine Glenmark Europe? 
Kakšne so koristi in tveganja, povezana z zdravilom Olanzapine Glenmark Europe?
Olanzapine Glenmark Europe 
Olanzapine Glenmark Europe olanzapin
Other information about Olanzapine Glenmark Europe 
Druge informacije o zdravilu Olanzapine Glenmark Europe
The active substance in Olanzapine Glenmark Europe, olanzapine, is an antipsychotic medicine. 
Zdravilna učinkovina zdravila Olanzapine Glenmark Europe je olanzapin, ki je antipsihotično zdravilo.
Olanzapine Glenmark Europe is a medicine containing the active substance olanzapine. 
Olanzapine Glenmark je zdravilo, ki vsebuje zdravilno učinkovino olanzapin.
Olanzapine Glenmark Europe is used to treat adults with schizophrenia. 
Zdravilo Olanzapine Glenmark Europe se uporablja za zdravljenje shizofrenije.
Why has Olanzapine Glenmark Europe been approved? 
Zakaj je bilo zdravilo Olanzapine Glenmark Europe odobreno?
What is Olanzapine Glenmark Europe? 
Kaj je zdravilo Olanzapine Glenmark Europe?
How has Olanzapine Glenmark Europe been studied? 
Kako je bilo zdravilo Olanzapine Glenmark Europe raziskano?
What is Olanzapine Glenmark Europe used for? 
Za kaj se zdravilo Olanzapine Glenmark Europe uporablja?
How does Olanzapine Glenmark Europe work? 
Kako zdravilo Olanzapine Glenmark Europe deluje?
How is Olanzapine Glenmark Europe used? 
Kako se zdravilo Olanzapine Glenmark Europe uporablja?
Patient demand being unfulfilled is unacceptable. 
Neizpolnjevanje potreb bolnikov je nesprejemljivo.
Both issues were considered potential serious risks to public health and were the basis for triggering the referral. 
Obe vprašanji sta se šteli za možni resni tveganji za javno zdravje ter za osnovo za sprožitev napotitvenega postopka.
The issue was resolved from a chemical-pharmaceutical point of view. 
Vprašanje je bilo rešeno s kemijskofarmacevtskega vidika.
The overall conclusion is that proposed plan presented by Baxter is acceptable. 
Splošni zaključek je, da je predlagani načrt družbe Baxter sprejemljiv.
Quality issues 
Vprašanja glede kakovosti
16494 Kista Sweden 
16494 Kista Švedska
In addition the new SLP-HS method will be implemented by the end of December 2009. 
Poleg tega bo nova metoda SLP-HS uvedena do konca decembra 2009.
Piazzale dell'Industria 20 00144 Roma Italy 
Piazzale dell'Industria 20 00144 Roma Italija
It corresponds to the limit of quantitation of the current SLP test. 
Ustreza mejni vrednosti kvantifikacije trenutnega testa SLP.
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF EXTRANEAL 
SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA ZDRAVILA EXTRANEAL
At the time of the CHMP opinion, there were minor unresolved quality issues, which have no impact on the Benefit/Risk ratio of the product. 
V času priprave mnenja CHMP so obstajala manjša nerešena vprašanja glede kakovosti, ki ne vplivajo na razmerje med koristmi in tveganji za zdravilo.
Moreover since it has not been possible to improve in short term manufacturing process of the active substance in one of currently approved manufacturing sites, this site will be removed by the end of the year for the European market and globally by the end of next year. 
Ker poleg tega kratkoročno ni bilo mogoče izboljšati postopka izdelave zdravilne učinkovine v enem izmed trenutno odobrenih proizvodnih obratov, bo njegovo obratovanje prekinjeno do konca leta za evropski trg in do konca naslednjega leta za druge države.
46394 Ribarroja del Turia (Valencia) Spain 
46394 Ribarroja del Turia (Valencia) Španija
15233 Halandri Athens Greece 
15233 Halandri Athens Grčija
It is presented as a sterile solution in 1.5, 2.0 and 2.5 liter bags and it is intended for peritoneal dialysis. 
Na voljo je kot sterilna raztopina v vrečkah po 1,5, 2,0 in 2,5 litra in je namenjeno peritonealni dializi.
The National Competent Authorities, coordinated by the Reference Member State, shall ensure that the following conditions relating to quality aspects are fulfilled by the Marketing Authorisation Holders within the specified time frame: 
Pristojni nacionalni organi, ki jih medsebojno usklajuje referenčna država članica, bodo zagotovili, da bodo imetniki dovoljenja za promet z zdravilom izpolnili naslednje pogoje v zvezi z vidiki kakovosti v določenem časovnem okviru:
Boulevard R. Branquart 80 7680 Lessines Belgium 
Boulevard R. Branquart 80 7680 Lessines Belgija
3542 CE Utrecht The Netherlands 
3542 CE Utrecht Nizozemska
- The Roquette Frères manufacturing site for the active substance will be removed from EU licences via appropriate variation procedure by February 2010. 
- Proizvodni obrat Roquette Frères za zdravilno učinkovino se z ustreznim postopkom za spremembo izbriše iz dovoljenj EU do februarja 2010.
85716 Unterschleissheim Germany 
85716 Unterschleissheim Nemčija
It is expected that the peptidoglycan levels in the drug product are indirectly controlled as well as the active substance currently appears to be the only source of this contamination. 
Pričakuje se, da so ravni peptidoglikanov v zdravilu posredno nadzorovane ter da je zdravilna učinkovina trenutno očitno edini izvor te kontaminacije.
The applicant was asked therefore to set acceptable limits for PG with the improved method. 
Predlagatelj je bil zato naprošen, da z izboljšano metodo določi sprejemljive mejne vrednosti za PG.
In view of the circumstances, the proposed limit for peptidoglycans in the aactive substance was considered acceptable until the end of the year. 
Glede na okoliščine se je predlagana mejna vrednost za peptidoglikane v zdravilni učinkovini štela za sprejemljivo do konca leta.
As no agreement was reached by NL on 9 July 2009 on the draft decision of the RMS, the procedure was referred to the CHMP according to Article 6(12) and the Referral procedure was initiated on 23 July 2009 with the adoption of a CHMP List of Questions to be addressed by the MAHs. 
Ker do 9. julija 2009 z Nizozemsko ni bil dosežen dogovor o osnutku odločitve referenčne države članice, je bil postopek napoten na CHMP v skladu s členom 6(12), napotitveni postopek pa se je začel 23. julija 2009 s sprejetjem seznama vprašanj CHMP, na katera mora odgovoriti imetnik dovoljenja za promet z zdravilom.
The applicant gave a Letter of Undertaking and committed to resolve it as a Follow-up Measure after the opinion, within an agreed timeframe. 
Predlagatelj je predložil pismo o zavezi in se obvezal, da jih bo z naknadnim ukrepom po izdaji mnenja rešil v dogovorjenem roku.
It should allow on peptidoglycan limit for the drug product which is considered to be sufficiently low from a chemicalpharmaceutical and toxicological point of view. 
Test bi moral omogočiti mejno vrednost peptidoglikanov v zdravilu, ki se šteje za dovolj nizko s kemijsko-farmacevtskega in toksikološkega vidika.
Baxter A/S Gydevang 43 3450 Allerød Denmark 
Baxter A/S Gydevang 43 3450 Allerød Danska
Previously this limit was not part of the finished product specification. 
Prej te mejne vrednosti ni bilo v specifikaciji končnega zdravila.
The product also contains as active ingredients sodium lactate, sodium chloride, calcium chloride and magnesium chloride. 
Zdravilo vsebuje zdravilne učinkovine natrijev laktat, natrijev klorid, kalcijev klorid in magnezijev klorid.
Baxter S.A.S 6 av. Louis Pasteur 78310 Maurepas France 
Baxter S.A.S 6 av. Louis Pasteur 78310 Maurepas Francija
ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES 
DODATEK I SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, POTI UPORABE ZDRAVILA, PREDLAGATELJEV, IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH