natgillin/translations-raw huggingface dataset:
The antigens are adjuvanted with 150 mg dl-α-tocopherol acetate per dose. 
En odmerek antigenov vsebuje 150 mg dl-α-tokoferol acetate kot adjuvans.
The fimbrial adhesins F4ab, F4ac, F5 and F6 are responsible for the adhesion and the virulence of E. coli strains, which cause neonatal enterotoxicosis in piglets. 
Fimbrijski adhezini F4ab, F4ac, F5 in F6 povzročajo adhezijo in virulenco sevov E. coli, ki so povzročitelji neonatalne enterotoksikoze pujskov.
THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN” Keep out of the reach and sight of children. 
BESEDILO ''ZDRAVILO SHRANJUJTE IZVEN DOSEGA IN POGLEDA OTROK'' Zdravilo shranjujte izven dosega in pogleda otrok.
To be supplied only on veterinary prescription. 
Izdaja zdravila za uporabo v veterinarski medicini je le na recept..
- Avoid introduction of contamination. 
− Pazite, da ne bi prišlo do kontaminacije.
4.7 Use during pregnancy, lactation or lay 
4.7 Uporaba v obdobju brejosti, laktacije ali nesnosti Lahko se uporablja v obdobju brejosti.
Vaccine to stimulate active immunity of sows/gilts in order to provide passive immunity to their progeny against E. coli strains that express the fimbrial adhesins F4ab, F4ac, F5 and F6. 
Cepivo za spodbujanje aktivne imunosti svinj ali mladic za razvoj pasivne imunosti potomcev proti sevom E.coli, ki izločajo fimbrijske adhezine F4ab, F4ac, F5 in F6.
A mean transient increase in body temperature of about 1°C, in some pigs up to 3°C, may occur in the first 24 hours after vaccination. 
Na splošno se lahko pri nekaterih prašičih prvih 24 ur po cepljenju dan prehodno povprečno za 1 °C, pri nekaterih prašičih do 3 °C, poveča telesna temperatura.
Cardboard box with 1 glass (hydrolytic type I) or 1 PET vial of 20, 50 or 100 ml with a halogenobutyl rubber stopper and a coded aluminium cap. Not all pack sizes may be marketed. 
Zloženka z 1 stekleno vialo (hidrolitične skupine I) ali 1 vialo iz PET po 20, 50 ali 100 ml z zamaškom iz halogenobutilne gume in aluminijasto zaporko s šifro.
NAME OF THE VETERINARY MEDICINAL PRODUCT Porcilis Porcoli Diluvac Forte suspension for injection 
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Porcilis Porcoli Diluvac Forte suspenzija za injiciranje
SPECIAL STORAGE PRECAUTIONS Store in a refrigerator (+2°C to +8°C). 
POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte pri temperaturi +2 - +8 ºC.
Other provisions dl-α-tocopherol acetatea 
Druge določbe dl-α-tokoferol acetata (vitamin E)
- F5 (K99) fimbrial adhesin 
fimbrijski adhezin F5 (K99)
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary 
4.10 Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi) (če so potrebni) Niso zasledili nikakršnih drugačnih neželenih učinkov kot tistih, ki so navedeni v razdelku Stranski učinki.
Potassium Chloride Potassium Dihydrogen Phosphate Simethicone emulsion Sodium chloride 
6.1 Seznam pomožnih snovi polisorbat 80 kalijev klorid kalijev dihidrogen fosfat simetikon, emulzija natrijev klorid dinatrijev fosfat dihidrat DL-alfa-tokoferol acetat voda za injekcije
STATEMENT OF ACTIVE AND OTHER SUBSTANCES Per dose of two ml: - F4ab (K88ab) fimbrial adhesin 
NAVEDBA ZDRAVILNIH UČINKOVIN IN DRUGIH SNOVI V odmerku po dva ml: fimbrijski adhezin F4ab (K88ab)
MANUFACTURER'S BATCH NUMBER Batch: ....... 
IZDELOVALČEVA ŠTEVILKA SERIJE IZDELAVE ZDRAVILA Serija: ……….
EXP {month/year} Once broached, use within 3 hours. 
Načeto/odprto zdravilo uporabite v 3 urah.
Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands. 
Wim de Körverstraat 35 5831 AN Boxmeer Nizozemska
NAME OF THE VETERINARY MEDICINAL PRODUCT Porcilis Porcoli Diluvac Forte 
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Porcilis Porcoli Diluvac Forte
BATCH NUMBER Batch: ...... 
ŠTEVILKA SERIJE Serija: ……….
CONTENTS BY WEIGHT, BY VOLUME OR NUMBER OF DOSES 20 ml (10 doses) 
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ODMERKOV 20 ml (10 odmerkov)
(E508) All food-producing species 
(E508) vse živali, namenjene za proizvodnjo živil kalijev dihidrogen fosfatc
PORCILIS PORCOLI DILUVAC FORTE 
NAVODILO ZA UPORABO ZA PORCILIS PORCOLI DILUVAC FORTE
For the passive immunisation of piglets by active immunisation of sows/gilts to reduce mortality and clinical signs such as diarrhoea due to neonatal enterotoxicosis during the first days of life, caused by those E.coli strains, which express the fimbrial adhesins F4ab (K88ab), F4ac (K88ac), F5 (K99) or F6 (987P). 
S tem se zmanjša smrtnost in klinični znaki, kot je driska zaradi neonatalne enterotoksikoze prve dni po rojstvu, ki jo povzročajo sevi E. coli, ki izločajo fimbrijske adhezine F4ab (K88ab), F4ac (K88ac), F5 (K99) ali F6 (987P).
- F6 (987P) fimbrial adhesin 
fimbrijski adhezin F6 (987P)
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE IN THE EEA, IF DIFFERENT 
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM TER IMETNIKA DOVOLJENJA ZA PROIZVODNJO ZDRAVILA, ODGOVORNEGA ZA SPROSTITEV SERIJ V EGP, ČE STA RAZLIČNA
CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Veterinary medicinal product subject to prescription. 
POGOJI ALI OMEJITVE GLEDE NAČINA/REŽIMA IZDAJE IN UPORABE Zdravilo se izda le na recept.
Simethiconeg 
KARENCA
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE 
IZDELOVALEC BIOLOŠKIH ZDRAVILNIH UČINKOVIN IN IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROSTITEV SERIJE
A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE 
A. IZDELOVALEC BIOLOŠKIH ZDRAVILNIH UČINKOVIN IN IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROSTITEV SERIJE
MARKETING AUTHORISATION NUMBER(S) EU/2/96/001/003-008 
ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/96/001/003-008
- F4ac (K88ac) fimbrial adhesin 
fimbrijski adhezin F4ac (K88ac)
Active substances: - F4ab (K88ab) fimbrial adhesin 
Zdravilne učinkovine: fimbrijski adhezin F4ab (K88ab)
Intervet International B.V. Wim de Körverstraat 35, P.O. 
Intervet International B.V.
4.8 Interaction with other medicinal products and other forms of interaction 
4.8 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Ni podatkov o varnosti ter učinkovitosti ob sočasni uporabi tega cepiva s katerim koli drugim cepivom.
OJ No L272 of 25.10.96 c OJ No L272 of 25.10.96 
(dimetikon) vse živali, namenjene za proizvodnjo živil a OJ št. L122 z dne 12.05.99 b OJ št L272 z dne 25.10.96 c OJ št. L272 z dne 25.10.96 d OJ št. L290 z dne 5.12.95 e OJ št. L272 z dne 25.10.96
PARTICULARS TO APPEAR ON THE OUTER PACKAGE 20 ml & 50 ml (EU/2/96/001/003, EU/2/96/001/004, EU/2/97/001/006 & EU/2/96/001/007) 
PODATKI NA ZUNANJI OVOJNINI 20 ml & 50 ml (EU/2/96/001/003, EU/2/96/001/006, EU/2/96/001/004 & EU/2/96/001/007)
PACKAGE SIZE 20 ml (10 doses) 50 ml (25 doses) 100 ml (50 doses) 
VELIKOST PAKIRANJA 20 ml (10 odmerkov) 50 ml (25 odmerkov) 100 ml (50 odmerkov)
PACKAGE SIZE 100 ml (50 doses) 
VELIKOST PAKIRANJA 100 ml (50 odmerkov)
In the case of accidental self-injection, seek medical advice immediately and show the package leaflet or label to the physician. 
Posebni varnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo V primeru nenamernega samo-injiciranja se takoj posvetujte z zdravnikom in mu pokažite navodila za uporabo ali nalepko na zunanji ovojnini.
Name and address of the manufacturer responsible for batch release 
Ime in naslov izdelovalca zdravila, odgovornega za sprostitev serije:
PARTICULARS TO APPEAR ON THE OUTER PACKAGE 100 ml (EU/2/96/001/005 & EU/2/96/001/008) 
PODATKI NA ZUNANJI OVOJNINI 100 ml (EU/2/96/001/005 & EU/2/96/001/008)
All food-producing species 
vse živali, namenjene za proizvodnjo živil kalijev kloridb
PACKAGE SIZE 50 ml (25 doses) 100 ml (50 doses) 
VELIKOST PAKIRANJA 50 ml (25 odmerkov) 100 ml (50 odmerkov)
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE 50 ml & 100 ml vial labels (EU/2/96/001/004, EU/2/96/001/005, EU/2/97/001/007 & EU/2/96/001/008 only) 
PODATKI NA STIČNI OZ. PRIMARNI OVOJNINI Nalepke na vialah po 50 ml in 100 ml (samo za EU/2/96/001/004, EU/2/96/001/005, EU/2/97/001/0007 in EU/2/96/001/008)
(E339ii) All food-producing species 
(E339ii) vse živali, namenjene za proizvodnjo živil polisorbat 80f vse živali, namenjene za proizvodnjo živil simetikong
1 Mean antibody titre (Ab) obtained after vaccination of mice with a 1/20 sow dose. 
1srednji titer protiteles po cepljenju miši z 1/20 odmerka za svinje dl-alfa-tokoferol acetat
DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED 
DATUM ZADNJE REVIZIJE NAVODIL ZA UPORABO
(E340i) All food-producing species 
(E340i) vse živali, namenjene za proizvodnjo živil natrijev kloridd vse živali, namenjene za proizvodnjo živil dinatrijev hidrogen fosfate
Neonatal piglets derive passive immunity via ingestion of colostrum from vaccinated sows/gilts. 
Pasivna imunizacija pujskov z aktivno imunizacijo svinj ali mladic.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 20 ml vial labels (EU/2/96/001/003 & EU/2/96/001/006 only) 
Nalepke na vialah po 20 ml (samo za EU/2/96/001/003 in EU/2/96/001/006)
EU/2/96/001/008 
EU/2/96/001/005 100 ml steklo EU/2/96/001/008 100 ml PET
EXPIRY DATE 
DATUM IZTEKA ROKA UPORABNOSTI EXP {mesec/leto}
NUMBERS IN THE COMMUNITY REGISTER OF MEDICINAL PRODUCTS EU/2/96/001/005 
ŠTEVILKA V REGISTRU ZDRAVIL SKUPNOSTI EU/2/96/001/005 100 ml steklo EU/2/96/001/008 100 ml PET
PACKAGE SIZE 20 ml (10 doses) 50 ml (25 doses) 
VELIKOST PAKIRANJA 20 ml (10 odmerkov)
Invented name Strength Pharmaceutical Form Route of administration Packaging 
Farmacevtska oblika Pot uporabe Ovojnina
1 vial + 1 ampoule 
1 viala + 1ampula
The European Commission issued a decision on this opinion on 28/04/2017. 
Evropska komisija je sklep v zvezi s tem mnenjem izdala 28/04/2017.
4.4 Special warnings and precautions 
Posebna opozorila in previdnostni ukrepi
Haldol Decanoate and associated names (such as Aloperidin Decanoas, Haldol Decanoas, Haldol Decanoat, Haldol Decanoate, Haldol Decanoato, Haldol Depot, Serenase Dekanoat, and Serenase Depot) is marketed in Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, the Netherlands, Norway, Portugal, Sweden and United Kingdom, and in Iceland and Norway. 
Haldol Decanoate in povezana imena (kot so Aloperidin Decanoas, Haldol Decanoas, Haldol Decanoat, Haldol Decanoate, Haldol Decanoato, Haldol Depot, Serenase Dekanoat in Serenase Depot) se trži v Avstriji, Belgiji, Franciji, Nemčiji, Grčiji, Italiji, Luksemburgu, na Cipru, Danskem, Finskem, Irskem, Nizozemskem, Norveškem, Portugalskem, Švedskem in v Združenem kraljestvu ter na Islandiji in na Norveškem.
The companies that market these medicines include Janssen-Cilag Ltd and associated companies. 
Ta zdravila tržijo družba Janssen-Cilag Ltd in povezana podjetja.
Low doses are recommended for elderly patients unless they have already been receiving higher doses of haloperidol and have not had unacceptable side effects. 
Za starejše bolnike so priporočljivi majhni odmerki, razen če so že prejemali večje odmerke haloperidola in niso imeli nesprejemljivih neželenih učinkov.
Haldol Decanoate is authorised in the EU via national procedures. 
Zdravilo Haldol Decanoate je bilo v EU odobreno po nacionalnih postopkih.
In particular, Haldol Decanoate must not be used in patients with heart disorders such as certain heart-rhythm problems, heart failure and recent heart attack, and with central nervous depression (reduced brain activity that slows down breathing and heart rate and reduces alertness). 
Zdravilo Haldol Decanoate se še zlasti ne sme uporabljati pri bolnikih s srčnimi boleznimi, kot so določene težave s srčnim ritmom, srčnim popuščanjem in nedavnim srčnim infarktom, ter pri bolnikih z depresijo centralnega živčevja (zmanjšano aktivnostjo možganov, ki upočasni dihanje in srčni utrip ter zmanjša budnost).
On 23 February 2017, the European Medicines Agency completed a review of Haldol Decanoate. 
Evropska agencija za zdravila je 23. februarja 2017 zaključila pregled zdravila Haldol Decanoate.
Why was Haldol Decanoate reviewed? 
Zakaj je bilo zdravilo Haldol Decanoate pregledano?
It is also available in the EU as generic haloperidol decanoate. 
V EU je na voljo tudi kot generični haloperidol dekanoat.
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that there is a need to harmonise the prescribing information for Haldol Decanoate in the European Union (EU). 
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da je treba uskladiti podatke o predpisovanju zdravila Haldol Decanoate v Evropski uniji (EU).
The CHMP harmonised other sections of the SmPC including interactions between Haldol Decanoate and other medicines (section 4.5), as well as information on pregnancy, lactation and fertility (section 
Odbor CHMP je uskladil druga poglavja povzetka glavnih značilnosti zdravila, vključno z medsebojnim delovanjem med zdravilom Haldol Decanoate in drugimi zdravili (poglavje 4.5) ter informacijami o nosečnosti, dojenju in plodnosti (poglavje 4.6).
Haldol Decanoate is given by injection into the muscle usually every 4 weeks, to patients who have been taking haloperidol by mouth. 
Zdravilo Haldol Decanoate se daje z injekcijo v mišico, običajno vsake 4 tedne, bolnikom, ki so pred tem jemali peroralni haloperidol.
What is Haldol Decanoate? 
Kaj je zdravilo Haldol Decanoate?
The CHMP agreed to harmonisation of Haldol Decanoate's contra-indications. 
Odbor CHMP je soglašal z uskladitvijo kontraindikacij za zdravilo Haldol Decanoate.
The CHMP agreed that Haldol Decanoate injection can be used for the continuing treatment of schizophrenia and schizoaffective disorder in adults who have been on a stable dose of haloperidol by mouth. 
Odbor CHMP je soglašal, da se zdravilo Haldol Decanoate v obliki injekcij lahko uporablja za nadaljevalno zdravljenje shizofrenije in shizoafektivne motnje pri odraslih, ki so pred tem prejemali stabilni peroralni odmerek haloperidola.
The CHMP harmonised the SmPC to include information on when Haldol Decanoate's side effects on movement might appear, details on mortality in the elderly, and effects on the heart and the brain. 
Odbor CHMP je uskladil povzetek glavnih značilnosti zdravila tako, da je vanj vključil informacije o tem, kdaj se lahko pojavijo neželeni učinki zdravila Haldol Decanoate, ki prizadenejo premikanje, podatke o smrtnosti pri starejših in učinke na možgane in srce.
It contains the active ingredient haloperidol decanoate. 
Vsebuje zdravilno učinkovino haloperidol dekanoat.
The SmPC recommends caution in patients who have a high level of the hormone prolactin and in those who have tumours that are worsened by prolactin. 
Povzetek glavnih značilnosti zdravila priporoča previdnost pri bolnikih z visokimi ravnmi hormona prolaktina in bolnikih s tumorji, ki jih prolaktin poslabša.
The CHMP has harmonised the guidance on calculating the dose of Haldol Decanoate based on the patient's dose of haloperidol by mouth. 
Odbor CHMP je uskladil smernico o izračunu odmerka zdravila Haldol Decanoate na podlagi odmerka haloperidola, ki ga je bolnik prejemal peroralno.
Haldol Decanoate is an antipsychotic medicine used for schizophrenia and schizoaffective disorder (schizophrenia with mood disorders), which are mental disorders that affect how the person thinks, feels or behaves. 
Haldol Decanoate je antipsihotično zdravilo, ki se uporablja za shizofrenijo in shizoafektivno motnjo (shizofrenijo z motnjami razpoloženja).
On 18 June 2014, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Haldol Decanoate and associated names in the EU. 
Da bi Evropska komisija uskladila dovoljenja za promet z zdravilom Haldol Decanoate in povezana imena v EU, je 18. junija 2014 zadevo napotila na odbor CHMP.
Haldol Decanoate was identified as needing harmonisation by the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh). 
Skupina za usklajevanje za postopek z medsebojnim priznavanjem in decentralizirani postopekzdravila za uporabo v humani medicini (CMDh) je ugotovila, da je za zdravilo Haldol Decanoate potrebno usklajevanje.
The four components of this comprehensive program are: 
Štiri komponente tega celovitega program so:
After first opening: 40 days 
Po prvem odprtju: 40 dni.
Please read the instructions carefully and follow them step by step. 
Prosimo, da natančno preberete navodila in jim sledite po korakih.
To date no other relevant epidemiological data are available. 
Do danes ni na voljo nobenih drugih ustreznih epidemioloških podatkov.
Other mechanisms, which have yet to be elucidated, may also be involved. 
Vpleteni so lahko tudi drugi mehanizmi, ki jih bo potrebno še pojasniti.
Primary Efficacy 
Primarna učinkovitost
It is not always possible to reliably estimate the frequency of their incidence in the population to be treated. 
Ni vedno mogoče zanesljivo oceniti pogostnosti njihove incidence pri obravnavani populaciji.
Patients with major depression. 
Bolniki s hudo depresijo.
These are usually mild to moderate. 
Ti so običajno blagi do zmerni.
Abuse potential and dependence 
Možnost zlorabe in odvisnost
Most data derives from the illicit use of GHB. 
Večina podatkov izvira iz prepovedane uporabe GHB.
Your doctor may gradually increase your dose. 
Zdravnik vam bo postopoma zviševal odmerek.
Children and adolescents Do not give this medicine to children and adolescents. 
Otroci in mladostniki Otrokom in mladostnikom ne dajajte tega zdravila.
• topiramate (used for treatment of epilepsy) 
• topiramat (uporablja se za zdravljenje epilepsije)
• medicines that increase central nervous system activity and antidepressants 
• zdravila, ki povečajo dejavnost centralnega živčnega sistema in antidepresive
* The CGI-c data were analysed by defining responders as those patients who were very much improved or much improved. 
* Podatke CGI-c so analizirali z določanjem bolnikov z odzivom, to so tisti, ki se jim je stanje zelo veliko ali veliko izboljšalo.
4 weeks 
4 tedni
You should take the labelled medicine bottle with you, even if it is empty. 
S seboj vzemite označeno plastenko zdravila, tudi če je že prazna.
Allée de la Recherche 60 B-1070 Brussels Belgium 
Allée de la Recherche 60 B-1070 Bruselj Belgija
Frequency estimate: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1000 to < 1/100); rare (≥ 1/10,000 to < 1/1000); very rare (< 1/10,000); not known (cannot be estimated from the available data). 
Ocena pogostnosti: zelo pogosti (≥ 1/10); pogosti (≥ 1/100 do < 1/10); občasni (≥ 1/1.000 do < 1/100); redki (≥ 1/10.000 do < 1/1.000); zelo redki (< 1/10.000), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
Single doses greater than 4.5 g have not been studied. 
Enkratnih odmerkov večjih od 4,5 g niso preučevali.
The most commonly reported adverse reactions are dizziness, nausea, and headache, all occurring in 10% to 20% of patients. 
Neželeni učinki, o katerih so najpogosteje poročali, so omotičnost, navzea in glavobol, ki se vsi pojavljajo pri 10 % do 20 % bolnikov.
You may need to moderate your intake of salt. 
Morda boste morali tudi omejiti vnos soli.
Whilst these effects are uncommon, if they do occur they are usually mild-to-moderate in nature. 
Čeprav so ti učinki le občasni, so takrat, ko se pojavijo, običajno blagi do zmerni.
Take Xyrem orally two times each night. 
Zdravilo Xyrem morate vzeti peroralno dvakrat vsako noč.
The primary efficacy measure in this trial was the frequency of cataplexy attacks. 
Primarno merilo učinkovitosti je bila pri tem preskušanju pogostnost kataplektičnih napadov.
What Xyrem is and what it is used for 
Kaj je zdravilo Xyrem in za kaj ga uporabljamo
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE 
POSEBNI VARNOSTNI UKREPI ZA ODSTRANJEVENJE NEUPORABLJENIH ZDRAVIL ALI IZ NJIH NASTALIH ODPADNIH SNOVI, KADAR SO POTREBNI
Patients with porphyria 
Bolniki s porfirijo
The adaptor can then be left in the bottle for all subsequent uses 
Adapter lahko pustite v plastenki za vse nadaljnje uporabe.
Secondary Efficacy Duration Active treatment and Dose (g/d) 
Trajanje Aktivno zdravljenje in odmerek (g/dan)
If you forget to take the first dose, take it as soon as you remember and then continue as before. 
Če ste pozabili vzeti prvi odmerek, ga vzemite takoj, ko se spomnite, in nato nadaljujte z jemanjem zdravila kot prej.
In each trial, the daily dose was divided into two equal doses. 
V vsakem preskušanju je bil dnevni odmerek razdeljen v dva enaka odmerka.
The risk of taking Xyrem during pregnancy is unknown, and, therefore, the use of Xyrem in pregnant women or women trying to become pregnant is not recommended. 
Tveganje jemanja zdravila Xyrem med nosečnostjo ni znano, zato njegova uporaba pri nosečnicah in ženskah, ki želijo zanositi ni priporočljiva.
If you are elderly, your doctor will monitor your condition carefully to check whether Xyrem is having the desired effects. 
Če ste starejši, bo zdravnik natančno spremljal vaše stanje, da bo ugotovil, ali ima zdravilo Xyrem pri vas želeni učinek.
It is unclear if some or all of these episodes correspond to true somnambulism (a parasomnia occurring during non-REM sleep) or to any other specific medical disorder. 
Ni jasno, ali so nekatere ali vse od teh epizod povezane s pravim somnambulizmom (parasomnija, ki se pojavi v času spanja NREM) ali pa z drugo specifično boleznijo.
Xyrem works by consolidating night-time sleep, though its exact mechanism of action is unknown. 
Zdravilo Xyrem deluje tako, da okrepi nočni spanec, čeprav natančen mehanizem delovanja ni znan.
Sodium oxybate and/or its metabolites are excreted into breast milk. 
Natrijev oksibat in/ali njegovi metaboliti se izločajo v materino mleko.
Whilst there is no clear evidence of emergence of dependence in patients taking sodium oxybate at therapeutic doses, this possibility cannot be excluded. 
Čeprav ni jasnih dokazov o pojavu odvisnosti pri bolnikih, ki jemljejo natrijev oksibat v terapevtskih odmerkih, te možnosti ne moremo izključiti.
Cheyne-Stokes respiration and apnoea have been observed. 
Opazili so tudi CheyneStokesovo dihanje in apnejo.
The safety and efficacy of sodium oxybate in children and adolescents aged 0-18 years has not been established. 
Varnost in učinkovitost natrijevega oksibata pri otrocih in mladostnikih, starih od 0 do18 let, nista bili ugotovljeni.
The following instructions explain how to prepare Xyrem. 
Naslednja navodila vam pojasnjujejo, kako morate pripraviti zdravilo Xyrem.
Xyrem 6 - 9 Modafinil 200-600 mg 
8 tednov Xyrem 6-9 modafinil 200-600 mg
On average, less than 5% of unchanged medicinal product appears in human urine within 6 to 8 hours after dosing. 
V povprečju se manj kot 5 % nespremenjenega zdravila pri ljudeh izloči s sečem v 6 do 8 urah po odmerku.
If you have liver problems, the starting dose should be halved. 
Če imate težave z jetri, je treba začetni odmerek razpoloviti.
Single doses of 4.5 g should not be given unless the patient has been titrated previously to that dose level. 
Enkratnih odmerkov po 4,5 g ne smemo dati bolniku, razen če je bil bolnikov odmerek že prej titriran do tega odmerka.
A minimum of one to two weeks is recommended between dose increments. 
Priporočljivo je, da med posameznimi povečanji odmerka preteče najmanj eden do dva tedna.
There have been very few women who have taken Xyrem sometime during their pregnancy and a few of them had spontaneous abortions. 
Manjše število nosečnic je v nekem obdobju nosečnosti jemalo zdravilo Xyrem in nekaj od njih je imelo spontan splav.
• If you are taking valproate, your daily dose of Xyrem will need to be adjusted (see section 3) as it may lead to interactions 
• Če jemljete valproat, vam bo moral zdravnik dnevni odmerek zdravila Xyrem prilagoditi (glejte poglavje 3), ker se lahko pojavijo interakcije.
Patients should always observe the same timing of dosing in relation to meals. 
Bolniki morajo zdravilo jemati vedno ob enakem času glede na obroke hrane.
Information about signs and symptoms associated with overdose with sodium oxybate is limited. 
Informacije o znakih in simptomih, povezanih s prevelikim odmerjanjem natrijevega oksibata, so omejene.