natgillin/translations-raw huggingface dataset:
For 800 micrograms ampoule only: after the first opening of the ampoule, store it in a refrigerator (2°C8°C). 
Samo za 800 mikrogramske ampule: po prvem odprtju ampulo shranjujte v hladilniku (2 °C - 8 °C).
Exp: Use the ampoules within 3 months from the first opening the pouch. 
EXP: Ampule uporabite v 3 mesecih po prvem odprtju vrečice.
After the first opening of the ampoule, store in a refrigerator (2°C - 8°C). 
Po prvem odprtju ampulo shranjujte v hladilniku (2 °C - 8 °C).
HOW TO STORE {INVENTED NAME} 
Kako uporabljati zdravilo {IZMIŠLJENO IME}
Growth retardation* (in children and adolescents), bone density decreased* 
Bolezni mišično-skeletnega sistema in vezivnega tkiva zaostanek v rasti∗ (pri otrocih in mladostnikih), zmanjšanje gostote kosti
Each 1 ml ampoule contains 400 micrograms beclometasone dipropionate. 
Ena 1-ml ampula vsebuje 400 mikrogramov beklometazondipropionata.
Each 2 ml ampoule contains 800 micrograms beclometasone dipropionate. 
Ena 2-ml ampula vsebuje 800 mikrogramov beklometazondipropionata.
CLENIL and associated names (see Annex I) 400 micrograms nebuliser suspension CLENIL and associated names (see Annex I) 800 micrograms nebuliser suspension 
CLENIL in povezana imena (glejte Prilogo I ) 400 mikrogramov suspenzija za nebulator CLENIL in povezana imena (glejte Prilogo I ) 800 mikrogramov suspenzija za nebulator
Excipients: polysorbate 20, sorbitan laurate, sodium chloride, water for injections 
Pomožne snovi: polisorbat 20, sorbitan lavrat, natrijev klorid, voda za injekcije
For 800 micrograms ampoule: after the first opening of the ampoule, store it in a refrigerator (2-8°C). 
Za 800 mikrogramsko ampulo: po prvem odprtju ampulo shranjujte v hladilniku (2◦C - 8◦C).
• cold sores (herpes simplex) painful blisterlike vesicles on your lips and in your mouth 
Redki neželeni učinki (pojavijo se lahko pri največ 1 od 1.000 bolnikov): • herpes simpleks, boleči mehurčki na ustnicah in ustih,
LIST OF EXCIPIENTS Excipients: polysorbate 20, sorbitan laurate, sodium chloride, water for injections 
SEZNAM POMOŽNIH SNOVI Pomožne snovi: polisorbat 20, sorbitan lavrat, natrijev klorid, voda za injekcije
CLENIL and associated names (see Annex I) 800 micrograms nebuliser suspension 
CLENIL in povezana imena (glejte Prilogo I ) 800 mikrogramov suspenzija za nebulator
Beclometasone was teratogenic and embryolethal in animals after, subcutaneous and oral administration. 
Beklometazon je bil pri živalih po subkutanem in peroralnem dajanju teratogen in je povzročil smrt zarodka.
CLENIL and associated names (see Annex I) 400 micrograms nebuliser suspension 
CLENIL in povezana imena (glejte Prilogo I ) 400 mikrogramov suspenzija za nebulator
The systemic pharmacodynamic effects of beclometasone dipropionate and its active metabolite B17MP is assessed by measuring the effects on hypothalamopituitary adrenal (HPA)-axis function. 
B17MP se ocenjuje z merjenjem učinkov na delovanje osi hipotalamus-hipofiza-nadledvične žleze
Laryngitis, pharyngitis 
Infekcijske in parazitske bolezni laringitis, faringitis
GENERAL CLASSIFICATION FOR SUPPLY Medicinal product subject to medical prescription INSTRUCTIONS ON USE 
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM
DATE OF REVISION OF THE TEXT [to be completed nationally] 
DATUM ZADNJE REVIZIJE BESEDILA
Each polyethylene ampoule contains 400 micrograms beclometasone dipropionate suspension in 1 ml. 
Ena polietilenska ampula vsebuje 400 mikrogramov beklometazondipropionata v 1 ml suspenzije.
Each ampoule contains 400 micrograms beclometasone dipropionate suspension in 1 ml. 
Ena ampula vsebuje 400 mikrogramov beklometazondipropionata v 1 ml suspenzije.
In children with recurrent wheezing, if no treatment benefit of is observed within 2-3 months, {INVENTED NAME} should be discontinued. 
Če se pri otrocih s ponavljajočim se piskajočim dihanjem ne opazi koristi zdravljenja v 2 do 3
Each ampoule contains 800 micrograms beclometasone dipropionate suspension in 2 ml. 
Ena ampula vsebuje 800 mikrogramov beklometazondipropionata v 2 ml suspenzije.
Each polyethylene ampoule contains 800 micrograms beclometasone dipropionate suspension in 2 ml. 
Ena polietilenska ampula vsebuje 800 mikrogramov beklometazondipropionata v 2ml suspenzije.
Use the ampoules within 3 months from the first opening the pouch. 
Ampulo uporabite v 3 mesecih po prvem odprtju vrečice.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Ampoule 
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH
Hypersensitivity reactions with the following manifestations: angioedema, rash, urticaria, pruritus, 
Bolezni imunskega sistema preobčutljivostne reakcije, ki se kažejo kot: angioedem, izpuščaj,
{INVENTED NAME} contains the active substance beclometasone dipropionate. 
Zdravilo {IZMIŠLJENO IME} vsebuje zdravilno učinkovino beklometazondipropionat.
PARTICULARS TO APPEAR ON THE INTERMEDIATE PACKAGING POUCH 
PODATKI NA STIČNI OVOJNINI VREČICA
Cleaning: 
Čiščenje
Once the nebuliser bowl cap is inserted, the nebuliser should be shaken gently to mix the content. 
Nebulator nežno pretresite, da vsebino premešate.
• sore throat (pharyngitis, laryngitis). 
kožni izpuščaj, koprivnica, srbenje ali rdečina).
{INVENTED NAME}{INVENTED NAME}If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 
Če imate dodatna vprašanja o uporabi zdravila, se posvetujte z zdravnikom ali farmacevtom.
beclometasone dipropionate 
OVOJNINAH ampula
Do not use the ampoule after 3 months from the date of first opening the pouch. 
Po 3 mesecih od datuma prvega odprtja vrečice ampul ne uporabljajte več.
What {INVENTED NAME} contains 
Kaj vsebuje navodilo
The active substance is beclometasone dipropionate. 
Zdravilna učinkovina je beklometazondipropionat.
What measures are being taken to ensure the safe and effective use of Blitzima? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Blitzima?
This means that Blitzima is highly similar to a biological medicine (also known as the ‘reference medicine') that is already authorised in the European Union (EU). 
To pomeni, da je zelo podobno biološkemu zdravilu (t. i. „referenčnemu zdravilu“), ki je že odobreno v Evropski uniji (EU).
This is a summary of the European public assessment report (EPAR) for Blitzima. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Blitzima.
Patients are also to receive an alert card to carry at all times, instructing them to contact their doctor immediately if they have any of the listed symptoms of infection. 
Bolniki morajo prejeti tudi opozorilno kartico, ki jo morajo imeti stalno pri sebi in na kateri je navedeno, da se morajo takoj posvetovati z zdravnikom, če občutijo kakršne koli navedene simptome okužbe.
In this study improvement was seen in 96% of cases (67 of 70 patients) with Blitzima and 90% (63 of 70 patients) with Rituxan. 
V tej študiji so izboljšanje opazili pri 96 % primerov (67 bolnikih od 70), zdravljenih z zdravilom Blitzima, in 90 % (63 bolnikih od 70), zdravljenih z zdravilom Rituxan.
Patients with GPA or MPA must also not receive Blitzima if they have severe heart problems. 
Bolniki z Wegenerjevo granulomatozo ali mikroskopskim poliangiitisom prav tako ne smejo prejemati zdravila Blitzima, če imajo hude težave s srcem.
The full EPAR for Blitzima can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The study showed that Blitzima and MabThera had comparable effects on arthritis symptoms: after 24 weeks, the proportion of patients with a 20% improvement in symptom score (called ACR20) was 74% (114 of 155 patients) with Blitzima and 73% (43 of 59 patients) with MabThera. 
Študija je pokazala, da sta zdravili Blitzima in MabThera primerljivo vplivali na simptome artritisa: po 24 tednih je delež bolnikov, pri katerih je bilo izboljšanje po lestvici simptomov (imenovani ACR20) 20odstotno, pri tistih bolnikih, ki so jemali zdravilo Blitzima, znašal 74 % (114 bolnikov od 155), pri tistih, ki so jemali zdravilo MabThera, pa 73 % (43 bolnikov od 59).
• granulomatosis with polyangiitis (GPA or Wegener's granulomatosis) and microscopic polyangiitis (MPA), which are inflammatory conditions of the blood vessels. 
• granulomatoze s poliangiitisom (GPA ali Wegenerjeve granulomatoze) in mikroskopskega poliangiitisa (MPA), ki sta vnetni bolezni krvnih žil.
Further evidence came from supportive studies, including one involving 121 patients with advanced follicular lymphoma, where adding Blitzima to chemotherapy medicines was at least as effective as adding Rituxan, the US version of MabThera. 
Dodatni dokazi izhajajo iz podpornih študij, vključno s študijo, v katero je bilo vključenih 121 bolnikov z napredovalim folikularnim limfomom, pri čemer je bilo dodajanje zdravila Blitzima kemoterapiji vsaj tako učinkovito kot dajanje zdravila Rituxan, ameriške različice zdravila MabThera.
What benefits of Blitzima have been shown in studies? 
Kakšne koristi je zdravilo Blitzima izkazalo v študijah?
What is Blitzima and what is it used for? 
Kaj je zdravilo Blitzima in za kaj se uporablja?
What are the risks associated with Blitzima? 
Kakšna tveganja so povezana z zdravilom Blitzima?
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Blitzima have also been included in the summary of product characteristics and the package leaflet. 
Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Blitzima upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
Blitzima should be given under the close supervision of an experienced healthcare professional and in a place where facilities for resuscitating patients are immediately available. 
Zdravilo Blitzima se lahko daje samo pod skrbnim nadzorom izkušenega zdravnika in na mestu, kjer so vsi pripomočki za oživljanje nemudoma na voljo.
The active substance in Blitzima, rituximab, is a monoclonal antibody (a type of protein) designed to recognise and attach to a protein called CD20 present on the surface of B cells (types of white blood cells). 
Zdravilna učinkovina v zdravilu Blitzima, rituksimab, je monoklonsko protitelo (vrsta beljakovine), ki je bilo zasnovano tako, da prepozna beljakovino, imenovano CD20, ki je prisotna na površini celic B (vrste belih krvnih celic), in se veže nanjo.
Thus, all these data were considered sufficient to conclude that Blitzima will behave in the same way in terms of effectiveness as MabThera in its approved indications. 
Vsi ti podatki so bili zato ocenjeni kot zadostni za zaključek, da se bo zdravilo Blitzima pri odobrenih indikacijah z vidika učinkovitosti vedlo enako kot zdravilo MabThera.
For more information about treatment with Blitzima, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Blitzima preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Other information about Blitzima 
Druge informacije o zdravilu Blitzima
Blitzima must not be used in people who are hypersensitive (allergic) to rituximab, mouse proteins or any of the other ingredients. 
Zdravila Blitzima ne smejo jemati osebe, ki so preobčutljive za (alergične na) rituksimab, mišje beljakovine ali na katero koli drugo sestavino zdravila.
The most common side effects with rituximab are reactions related to the infusion (such as fever, chills and shivering) which occur in most cancer patients and in more than 1 in 10 GPA or MPA patients at the time of the first infusion. 
Najpogostejši neželeni učinki rituksimaba so reakcije, povezane z infuzijo (kot so zvišana telesna temperatura, mrzlica in drgetanje), ki se po prvi infuziji pojavljajo pri večini bolnikov z rakom in pri več kot 1 od 10 bolnikov z Wegenerjevo granulomatozo ali mikroskopskim poliangiitisom.
In addition, a study comparing Blitzima to MabThera in patients with rheumatoid arthritis (which can support its use in other inflammatory disorders such as GPA and MPA) showed that both medicines are similarly effective, and a supportive study in follicular lymphoma showed effectiveness in cancer. 
Poleg tega so s študijo, v kateri so zdravilo Blitzima primerjali z zdravilom MabThera pri bolnikih z revmatoidnim artritisom (kar podpira njegovo uporabo pri drugih vnetnih boleznih, kot sta Wegenerjeva granulomatoza in mikroskopski poliangiitis), dokazali, da sta obe zdravili podobno učinkoviti, podporna študija pri folikularnem limfomu pa je dokazala učinkovitost pri raku.
Depending on the condition it is used to treat, Blitzima may be given with chemotherapy (other cancer medicines) or medicines used for inflammatory disorders (corticosteroids). 
Zdravilo Blitzima se glede na bolezen, za katero se uporablja, lahko daje s kemoterapijo (drugimi zdravili za zdravljenje raka) ali z zdravili za zdravljenje vnetnih bolezni (kortikosteroidi).
Doctors prescribing Blitzima for cancer will be provided with educational material reminding them of the need to use the medicine only by infusion into a vein. 
Zdravniki, ki predpisujejo zdravilo Blitzima za zdravljenje raka, bodo prejeli izobraževalno gradivo, v katerem bodo opozorjeni na to, da je zdravilo treba dajati le z infundiranjem v veno.
Therefore, the Agency's view was that, as for MabThera, the benefit outweighs the identified risk and it recommended that Blitzima be given marketing authorisation. 
Agencija je tako menila, da enako kot pri zdravilu MabThera, koristi odtehtajo znana tveganja, in priporočila, da se za zdravilo Blitzima izda dovoljenje za promet.
It is not intended to provide practical advice on how to use Blitzima. 
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
Why is Blitzima approved? 
Zakaj je bilo zdravilo Blitzima odobreno?
Because Blitzima is a biosimilar medicine, the studies on effectiveness and safety of rituximab carried out with MabThera do not all need to be repeated for Blitzima. 
Zdravilo Blitzima je „podobno biološko zdravilo“, zato študij o učinkovitosti in varnosti rituksimaba, izvedenih z zdravilom MabThera, z zdravilom Blitzima ni treba ponavljati.
The reference medicine for Blitzima is MabThera. 
Referenčno zdravilo za zdravilo Blitzima je zdravilo MabThera.
Blitzima is a medicine used in adults to treat the following blood cancers and inflammatory conditions: 
Zdravilo Blitzima se uporablja za zdravljenje naslednjih krvnih rakov in vnetnih bolezni pri odraslih:
For practical information about using Blitzima, patients should read the package leaflet or contact their doctor or pharmacist. 
Za praktične informacije o uporabi zdravila Blitzima naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Blitzima has a highly similar structure, purity and biological activity to MabThera and is distributed in the body in the same way. 
Evropska agencija za zdravila je zaključila, da je bilo v skladu z zahtevami EU glede podobnih bioloških zdravil dokazano, da je zdravilo Blitzima po zgradbi, čistosti in biološkem delovanju zelo podobno zdravilu MabThera in da se po telesu enako porazdeli.
For the full list of side effects reported with Blitzima, see the package leaflet. 
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Blitzima, glejte navodilo za uporabo.
The company that markets Blitzima will provide doctors and patients using the medicine for non-cancer conditions with educational material including information on the need to give the medicine where facilities for resuscitation are available and on the risk of infection, including PML. 
Družba, ki trži zdravilo Blitzima, bo za zdravnike in bolnike, ki uporabljajo zdravilo za nerakave bolezni, pripravila izobraževalno gradivo, v katerem bo opisano, da je zdravilo treba dajati na mestu, kjer je na voljo oprema za oživljanje, in da obstaja tveganje okužbe, vključno s progresivno multifokalno levkoencefalopatijo (PML).
Blitzima is a ‘biosimilar medicine'. 
Zdravilo Blitzima je „podobno biološko zdravilo“.
Laboratory studies comparing Blitzima with MabThera have shown that the active substance in Blitzima is highly similar to that in MabThera in terms of structure, purity and biological activity. 
Laboratorijske študije, v katerih so zdravilo Blitzima primerjali z zdravilom MabThera, so pokazale, da je zdravilo Blitzima po zgradbi, čistosti in biološkem delovanju zelo podobno zdravilu MabThera.
How is Blitzima used? 
Kako se zdravilo Blitzima uporablja?
How does Blitzima work? 
Kako zdravilo Blitzima deluje?
In addition, Blitzima has been compared with MabThera given into a vein in a main study involving 372 patients with active rheumatoid arthritis (an inflammatory disease). 
Poleg tega so zdravilo Blitzima v glavni študiji, v katero je bilo vključenih 372 bolnikov z aktivnim revmatoidnim artritisom (vnetno boleznijo), primerjali z zdravilom MabThera, injiciranim v veno.
Studies have also shown that giving Blitzima produces similar levels of the active substance in the body to giving MabThera. 
Študije so pokazale tudi, da je količina zdravilne učinkovine v telesu pri zdravilu Blitzima podobna kot pri zdravilu MabThera.
Blitzima contains the active substance rituximab. 
Zdravilo Blitzima vsebuje zdravilno učinkovino rituksimab.
Blitzima can only be obtained with a prescription. 
Predpisovanje in izdaja zdravila je le na recept.
Medicines are not always suitable for everyone. 
Zdravila niso vedno primerna za vsakogar.
The clinical significance of these changes is unknown. 
Klinični pomen teh sprememb ni znan.
The other 2 studies were negative. 
Preostali dve študiji sta bili negativni.
However, they can be serious in some patients. 
Ne glede na to pa so lahko resni pri nekaterih bolnikih.
2740-271 Porto Salvo Portugal 
2740-271 Porto Salvo Portugalska
Frequency not Known 
Pogostnost ni znana
You should therefore not drive or operate machinery, until you know how this medication affects your ability to perform these activities. 
Ne vozite in ne upravljajte s stroji, dokler ne veste kako to zdravilo vpliva na vaše sposobnosti za opravljanje teh dejavnosti.
It may take several weeks before your symptoms begin to improve 
Preteče lahko več tednov, preden se vam začnejo simptomi izboljševati
Take your medication once daily either in the morning or evening. 
Vzemite zdravilo enkrat na dan, zjutraj ali zvečer.
Your doctor has decided that this medicine is suitable for treating your illness. 
Vaš zdravnik se je odločil da je to zdravilo primerno za zdravljenje vaše bolezni.
This will depend on the nature of your illness and how well you are responding to the treatment. 
To je odvisno od narave vaše bolezni in od tega, kako dobro se odzivate na zdravljenje.
There are no well controlled studies in pregnant women. 
Pri nosečnicah ni ustreznih in dobro nadzorovanih študij.
If you are being treated for this disorder, your doctor will want to monitor you closely (see Use in children and adolescents below). 
Če se zdravite za to boleznijo, vas bo vaš zdravnik hotel pozorno spremljati (glejte Uporaba pri otrocih in mladostnikih spodaj).
The mixture may be a little cloudy, but this is normal. 
Mešanica je lahko rahlo motna, toda to je normalno.
Distribution Approximately 98% of the circulating drug is bound to plasma proteins. 
Porazdelitev Približno 98 % zdravila v obtoku je vezanega na plazemske beljakovine.
(For symptoms, see section 4. 
(Za simptome glejte poglavje 4.
In a majority of instances the complications begin immediately or soon (<24 hours) after delivery. 
Večinoma se zapleti pojavijo takoj ali kmalu (< 24 ur) po porodu.
The National Competent Authorities, coordinated by the Reference Member State, shall ensure that the following conditions are fulfilled by the Marketing Authorisation Holders: 
Pristojni nacionalni organi, ki jih usklajuje referenčna država članica, morajo zagotoviti, da imetniki dovoljenja za promet z zdravilom izpolnijo naslednje pogoje:
This medicinal product contains 12 % ethanol (alcohol) and must be diluted before use. 
Zdravilo vsebuje 12 % etanola (alkohola) in ga je treba pred uporabo razredčiti.
The primary efficacy variable was defined based on the average number of panic attacks during the last two weeks of treatment. 
Glavni pokazatelj učinkovitosti je bil opredeljen na podlagi povprečnega števila paničnih napadov v zadnjih dveh tednih zdravljenja.
Medicines should not be disposed of via wastewater or household waste. 
Zdravila ne smete vreči v odpadne vode ali gospodinjske odpadke.
However, the CHMP considered that the two positive studies allow to conclude on efficacy and adopted the following indication: 
Vendar pa je CHMP ocenil, da dve pozitivni študiji dopuščata sklep o učinkovitosti, in sprejel naslednjo indikacijo:
• If you are a young adult. 
- Če ste mlajša odrasla oseba.
Patients with depression should be treated for a sufficient period of time of at least 6 months to ensure they are free from symptoms. 
Bolnike z depresijo je treba zdraviti dovolj dolgo, vsaj 6 mesecev, da so zanesljivo brez simptomov.
The results show that only two of the four studies demonstrated efficacy while the remaining two studies were negative. 
Rezultati so pokazali, da le dve od štirih študij izkazujeta učinkovitost zdravila, medtem ko sta preostali dve študiji negativni.
In the other three short term studies, most patients were females with PTSD due to domestic abuse or sexual/physical trauma. 
V preostalih treh kratkoročnih študijah je bila večina bolnikov ženskega spola s PTSM zaradi zlorabe v domačem okolju ali spolne/fizične travme.
Injury and poisoning 
Poškodbe in zastrupitve poškodba
This may be water, ginger ale, lemon/lime soda, lemonade or orange juice. 
To je lahko voda, ingverjevo pivo, limonina/limetina soda, limonada ali pomarančni sok.
Increasing the dose may be harmful to patients who develop such symptoms. 
Povečanje odmerka je lahko škodljivo za bolnike, ki razvijejo take simptome.
Therefore the CHMP considered that long-term efficacy (maintenance of effect) has not been demonstrated. 
CHMP je zato menil, da dolgoročna učinkovitost (vzdrževanje učinka) ni bila dokazana.
In addition, the MAH proposed harmonised wordings for sections 4.4, 4.5, 4.6, 4.7, 4.8 and 4.9 as well as for sections 5.1, 5.2 and 5.3. 
Poleg tega je imetnik dovoljenja za promet z zdravilom predlagal usklajena besedila za poglavja 4.4, 4.5, 4.6, 4.7, 4.8 in 4.9 ter poglavja 5.1, 5.2 in 5.3.
Vetenskapsvägen 10 191 90 Sollentuna Sweden 
Vetenskapsvägen 10 191 90 Sollentuna Švedska
Pooled analysis and postmarketing experience (frequency not known). 
Kumulativna analiza in izkušnje iz obdobja trženja (pogostnost ni znana).
Only a small amount (<0.2%) of unchanged sertraline is excreted in the urine. 
Le malo (< 0,2 %) nespremenjenega sertralina se izloči v urinu.
Zoloft was included in the list of products for Summary of Products Characteristics (SPC) harmonisation, drawn up by the CMD(h), in accordance with Article 30(2) of Directive 2001/83/EC, as amended. 
Zdravilo Zoloft je bilo vključeno na seznam zdravil za uskladitev povzetka glavnih značilnosti zdravila (SPC), ki ga je pripravila skupina CMD(h), v skladu s členom 30(2) Direktive 2001/83/ES, kakor je bila spremenjena.
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF ZOLOFT AND ASSOCIATED NAMES (SEE ANNEX I) 
SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA ZDRAVILA ZOLOFT IN Z NJIM POVEZANIH IMEN (GLEJTE DODATEK I)
Establish and maintain an airway and ensure adequate oxygenation and ventilation, if necessary. 
Zagotoviti in vzdrževati je treba prehodne dihalne poti ter poskrbeti za oksigenacijo in ventilacijo, če je potrebno.
de Europa, 20 B Parque Empresarial La Moraleja 28108 Alcobendas (Madrid) SPAIN 
de Europa, 20 B Parque Empresarial La Moraleja 28108 Alcobendas (Madrid) Španija
In summary, the CHMP adopted the following harmonised wording: 
Tako je CHMP sprejel naslednje usklajeno besedilo: