FrancophonIA/ELRC3.0 huggingface dataset:
English: Once opened use by…
Slovenian: Odprto zdravilo uporabite do: .......
English: Incompatibilities: Not applicable
Slovenian: Inkompatibilnosti:
English: Fold wings down along the intraruminal device body and insert the device into an appropriate administration tool, orifice end first.
Slovenian: Krilca zapognite navzdol vzdolž telesa intraruminalnega sistema in sistem vstavite v ustrezno orodje za dajanje zdravila, z ustjem naprej.
English: Metabolites and parent drug are excreted in the bile.
Slovenian: Presnovki in matično zdravilo se izločijo v žolč.
English: PHARMACEUTICAL FORM Continuous-release intraruminal device.
Slovenian: FARMACEVTSKA OBLIKA Intraruminalni sistem s kontinuiranim sproščanjem.
English: The excipients listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required, or are considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Slovenian: Uredbe Komisije (EU) št. 37/2010 določa, da MRL ni potreben, ali pa ne spadajo v področje uporabe
English: Use gloves when handling an intraruminal device, including during retrieval of a regurgitated intraruminal device.
Slovenian: Pri ravnanju z intraruminalnim sistemom, tudi pri odstranjevanju regurgitiranega intraruminalnega sistema, nosite rokavice.
English: 4.7 Use during pregnancy, lactation or lay
Slovenian: 4.7 Uporaba v obdobju brejosti, laktacije ali nesnosti Lahko se uporablja v obdobju brejosti in laktacije.
English: Be sure the head of the administration tool is past the base of the tongue.
Slovenian: Zagotovite, da je glava orodja za dajanje globlje od korena jezika.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/12/145/001
Slovenian: ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/12/145/001
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE FOIL-BAG CONTAINING 1,3 OR 5 CONTINUOUS-RELEASE INTRARUMINAL DEVICES
Slovenian: VREČKA IZ FOLIJE, KI VSEBUJE 1, 3 ALI 5 INTRARUMINALNIH SISTEMOV S KONTINUIRANIM SPROŠČANJEM
English: MARKETING AUTHORISATION NUMBER(S) EU/2/12/145/001-003
Slovenian: ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/12/145/001-003
English: In the peri-parturient dairy cow, the positive effects of monensin include reduced blood ketones, increased serum glucose and reduced incidence of ketosis.
Slovenian: Pri kravah molznicah v obporodnem obdobju so pozitivni učinki monezina med drugim znižanje ketonov v krvi,
English: Adequate animal restraint is required to properly administer this intraruminal device.
Slovenian: Za pravilno dajanje intraruminalnega sistema je treba žival ustrezno pridržati.
English: Lactose monohydrate Magnesium stearate Silica, colloidal anhydrous
Slovenian: FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi Podenota saharozni ester maščobnih kislin karbomer laktoza monohidrat magnezijev stearat silicijev dioksid, koloidni brezvodni
English: For the reduction in the incidence of ketosis in the peri-parturient dairy cow/heifer which is expected to develop ketosis.
Slovenian: INDIKACIJA(E) Za zmanjšanje pojavnosti ketoze pri kravah molznicah in telicah v obporodnem obdobju, pri katerih se pričakuje razvoj ketoze.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Kexxtone 32.4g continuous-release intraruminal device for cattle
Slovenian: IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Kexxtone 32,4 g intraruminalni sistem s kontinuiranim sproščanjem za govedo
English: STATEMENT OF ACTIVE SUBSTANCES 35.2 g monensin sodium (equivalent to 32.4 g monensin)
Slovenian: 35,2 g monenzin natrija (kar ustreza 32,4 g monenzina).
English: *The polypropylene components are coloured with sunset yellow E110
Slovenian: Sistem polipropilenska* zaporka ustja polipropilenski* bat polipropilenski* vsebnik in krilce jeklena vzmet *Polipropilenske komponente so obarvane z oranžnim barvilom E110.
English: If this occurs re-administer the intraruminal device if undamaged.
Slovenian: Če ne požira ali če regurgitira, ponovno dajte isti intraruminalni sistem, če ta ni poškodovan.
English: The site of action for intraruminal administered monensin is the gastrointestinal tract.
Slovenian: Mesto delovanja intraruminalno uporabljenega monenzina so prebavila.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Kexxtone 32.4g continuous-release intraruminal device for cattle monensin
Slovenian: IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Kexxtone 32,4 g intraruminalni sistem s kontinuiranim sproščanjem za govedo monenzin
English: Continuous-release intraruminal device.
Slovenian: Intraruminalni sistem s kontinuiranim sproščanjem.
English: Shelf life of the veterinary medicinal product as packaged for sale: 3 years Shelf life after first opening the immediate packaging: 6 months
Slovenian: Rok uporabnosti zdravila v pakiranju za prodajo: 3 leta.
English: Introduce the administration tool into the mouth avoiding the front teeth.
Slovenian: V gobec ji potisnite orodje za dajanje zdravila, pri čemer se izogibajte sekalcem.
English: If damaged,
Slovenian: Če je le-ta poškodovan, dajte novega.
English: PACKAGE LEAFLET: Kexxtone 32.4g continuous-release intraruminal device for cattle
Slovenian: NAVODILO ZA UPORABO Kexxtone 32,4 g intraruminalni sistem s kontinuiranim sproščanjem za govedo
English: The highest tolerated dose is typically between 1 mg and 2 mg monensin/kg bodyweight/day.
Slovenian: Najvišji dnevni odmerek, ki ga živali prenašajo, je običajno med 1 mg in
English: Insert the administration tool past the base of the tongue making sure to avoid the molar teeth.
Slovenian: Orodje za dajanje potisnite mimo korena jezika in se pri tem izogibajte kočnikom.
English: None
Slovenian: RAZLIČNA
English: Monensin A Bovine 2 μg/kg
Slovenian: 2 mg monenzina/kg telesne mase.
English: Not applicable
Slovenian: NE UPORABLJAJTE
English: Special precautions for storage
Slovenian: 6.4 Posebna navodila za shranjevanje
English: EXP {month/year}
Slovenian: DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA EXP: {mesec/leto}
English: MARKETING AUTHORISATION HOLDER
Slovenian: DATUM ZADNJE ODOBRITVE NAVODIL ZA UPORABO
English: In order to avoid trauma and damage to the pharynx and oesophagus, do not use excessive force.
Slovenian: Ne uporabljajte pretirane sile, da ne poškodujete žrela in požiralnika.
English: The maximum daily dose should not exceed 15 mg per kilogram body weight.
Slovenian: Dnevni odmerek ne sme preseči 15 mg na kilogram telesne mase.
English: Kolbam is available as capsules (50 and 250 mg).
Slovenian: Zdravilo je na voljo v obliki kapsul (50 in 250 mg).
English: This was consistent with clinical expectations and literature data.
Slovenian: Rezultati so bili skladni s kliničnimi pričakovanji in podatki iz literature.
English: Kolbam should be taken every day at approximately the same time, with a meal.
Slovenian: Zdravilo Kolbam je treba jemati vsak dan ob približno istem času, in sicer z obrokom.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Kolbam on 20 November 2015.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Kolbam, veljavno po vsej Evropski uniji, izdala 20. novembra 2015.
English: What measures are being taken to ensure the safe and effective use of Kolbam?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Kolbam?
English: Kolbam cholic acid
Slovenian: Kolbam holna kislina
English: Kolbam must not be used in combination with phenobarbital (a medicine for epilepsy).
Slovenian: Zdravilo Kolbam se ne sme uporabljati v kombinaciji s fenobarbitalom (zdravilom proti epilepsiji).
English: Regarding its safety, the side effects appeared to be non-serious and reversible.
Slovenian: Z vidika varnosti tega zdravila se zdi, da neželeni učinki niso resni in so reverzibilni.
English: The efficacy of Kolbam for the authorised indications was established based on the results of this study.
Slovenian: Učinkovitost zdravila Kolbam za odobrene indikacije je bila določena na osnovi rezultatov te študije.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Kolbam's benefits are greater than its risks and recommended that it be approved for use in the EU.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da so koristi zdravila Kolbam večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
English: For small children who cannot swallow capsules, the contents can be mixed in with infant formula, expressed breast milk, mashed potatoes or fruit puree.
Slovenian: Majhnim otrokom, ki ne morejo pogoltniti kapsul, se lahko vsebina zmeša z otroško formulo, iztisnjenim materinim mlekom, krompirjevim pirejem ali sadno kašico.
English: This is because it has not been possible to obtain complete information about Kolbam due to the rarity of the disease.
Slovenian: Do tega je prišlo zato, ker zaradi redkosti bolezni ni bilo mogoče pridobiti vseh informacij o njem.
English: This is a summary of the European public assessment report (EPAR) for Kolbam.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Kolbam.
English: Kolbam has been authorised under ‘exceptional circumstances'.
Slovenian: Zdravilo Kolbam je pridobilo dovoljenje za promet „v izjemnih okoliščinah“.
English: It is not intended to provide practical advice on how to use Kolbam.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Kolbam can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Slovenian: Povzetek mnenja Odbora za zdravila sirote za zdravilo Kolbam je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation
English: The main measures of effectiveness were changes in bile acid levels and liver function before and after treatment with Kolbam.
Slovenian: Glavno merilo učinkovitosti so bile spremembe v ravneh žolčnih kislin in delovanju jeter pred zdravljenjem z zdravilom Kolbam in po njem.
English: The most common side effects (which may affect up to 1 in 10 people) are peripheral neuropathy (nerve damage in the hands and feet), diarrhoea, nausea (feeling sick), acid reflux (stomach acid flowing up into the mouth), oesophagitis (inflammation of the food pipe), jaundice (yellowing of the skin and eyes), skin problems (lesions) and malaise (feeling unwell).
Slovenian: Najpogostejši neželeni učinki (ki lahko prizadenejo največ 1 osebo od 10) so periferna nevropatija (poškodba živcev v dlaneh in stopalih), driska, navzeja (slabost), želodčni refluks (dvigovanje želodčne kisline v usta), ezofagitis (vnetje požiralnika), zlatenica (rumena koža in oči), težave s kožo (lezije) in splošno slabo počutje.
English: What is Kolbam and what is it used for?
Slovenian: Kaj je zdravilo Kolbam in za kaj se uporablja?
English: The daily dose is chosen and adjusted during treatment for each patient depending on the patient's levels of bile acids in their blood and urine and their liver function.
Slovenian: Dnevni odmerek se določi in nato prilagaja med zdravljenjem za vsakega bolnika posebej glede na ravni žolčnih kislin v krvi in urinu ter delovanje jeter.
English: What benefits of Kolbam have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Kolbam izkazalo v študijah?
English: This helps to reduce the production of abnormal bile acids and contributes to the normal activity of bile in the digestive system, thereby relieving the symptoms of the condition.
Slovenian: To pomaga zmanjšati tvorbo nenormalnih žolčnih kislin in prispeva k normalnemu delovanju žolča v prebavilih ter tako lajša simptome te bolezni.
English: Because the number of patients with inborn errors in primary bile acid synthesis is low, the condition is considered ‘rare', and Kolbam was designated an ‘orphan medicine' (a medicine used in rare diseases) on 28 October 2009.
Slovenian: Ker je bolnikov s prirojenimi napakami v sintezi primarnih žolčnih kislin malo, velja ta bolezen za redko, zato je bilo zdravilo Kolbam 28. oktobra 2009 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni).
English: A risk management plan has been developed to ensure that Kolbam is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila Kolbam je bil pripravljen načrt obvladovanja tveganj.
English: Cholic acid is one of the main primary bile acids produced by the liver.
Slovenian: Holna kislina je ena od glavnih primarnih žolčnih kislin, ki jih tvorijo jetra.
English: For more information about treatment with Kolbam, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Kolbam preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: Why is Kolbam approved?
Slovenian: Zakaj je bilo zdravilo Kolbam odobreno?
English: The condition is known as ‘inborn errors in primary bile acid synthesis'.
Slovenian: To obolenje imenujemo „prirojene napake v sintezi primarnih žolčnih kislin“.
English: The full EPAR and risk management plan summary for Kolbam can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) in povzetek načrta obvladovanja tveganj za zdravilo Kolbam sta na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: What are the risks associated with Kolbam?
Slovenian: Kakšna tveganja so povezana z zdravilom Kolbam?
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Kolbam, including the appropriate precautions to be followed by healthcare professionals and patients.
Slovenian: V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
English: When primary bile acids are lacking, the body produces abnormal bile acids instead, which can damage the liver potentially leading to life-threatening liver failure.
Slovenian: Če teh primarnih žolčnih kislin primanjkuje, telo namesto njih tvori nenormalne žolčne kisline, ki lahko poškodujejo jetra in povzročijo njeno odpoved, kar je lahko smrtno nevarno.
English: Side effects with Kolbam are generally mild to moderate in severity and transitory.
Slovenian: Neželeni učinki zdravila Kolbam so na splošno blagi do zmerni in prehodni.
English: What information is still awaited for Kolbam?
Slovenian: Katere informacije o zdravilu Kolbam še pričakujemo?
English: Other information about Kolbam
Slovenian: Druge informacije o zdravilu Kolbam
English: Kolbam can only be obtained with a prescription and treatment should be started and supervised by a doctor specialised in the diseases Kolbam is used to treat.
Slovenian: Izdaja zdravila Kolbam je le na recept, zdravljenje pa mora uvesti in nadzirati zdravnik, specializiran za bolezni, za zdravljenje katerih se uporablja zdravilo Kolbam.
English: For practical information about using Kolbam, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Kolbam naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: In addition, the company that markets Kolbam will provide educational material with information on the correct and safe use of Kolbam to all doctors expected to prescribe this medicine.
Slovenian: Poleg tega bo družba, ki trži zdravilo Kolbam, vsem zdravnikom, ki naj bi predpisovali to zdravilo, priskrbela izobraževalno gradivo z informacijami o njegovi pravilni in varni uporabi.
English: The cholic acid contained in Kolbam replaces the patient's missing cholic acid.
Slovenian: Holna kislina, ki jo vsebuje zdravilo Kolbam, nadomesti holno kislino, ki je primanjkuje bolniku.
English: Since Kolbam has been approved under exceptional circumstances, the company that markets Kolbam will monitor the benefits and safety of Kolbam from a patient registry and provide yearly updates.
Slovenian: Ker je zdravilo Kolbam pridobilo dovoljenje za promet v izjemnih okoliščinah, bo družba, ki ga trži, s pomočjo registra bolnikov spremljala njegove koristi in varnost ter zagotovila vsakoletne posodobitve.
English: How does Kolbam work?
Slovenian: Kako zdravilo Kolbam deluje?
English: This is a ‘primary bile acid', which is a main component of the bile (a fluid produced by the liver that helps to digest fats).
Slovenian: Ta spada med primarne žolčne kisline, ki so glavna sestavina žolča (tekočine, ki se tvori v jetrih in pomaga pri presnovi maščob).
English: Kolbam was investigated in one main study involving 52 patients with inborn errors in primary bile acid synthesis, including 7 patients who lack either sterol 27-hydroxylase, 2-methylacyl-CoA racemase or cholesterol 7α-hydroxylase.
Slovenian: Zdravilo Kolbam so proučevali v eni glavni študiji, v kateri je sodelovalo 52 bolnikov s prirojenimi napakami v sintezi primarnih žolčnih kislin, vključno s sedmimi bolniki, ki jim je primanjkovalo sterol 27-hidroksilaze, 2-metilacil-CoA racemaze ali holesterol 7hidroksilaze.
English: Kolbam is a medicine that contains the active substance cholic acid.
Slovenian: Kolbam je zdravilo, ki vsebuje zdravilno učinkovino holna kislina.
English: How is Kolbam used?
Slovenian: Kako se zdravilo Kolbam uporablja?
English: The CHMP concluded that Kolbam has beneficial effects in patients with deficiencies in the following liver enzymes: sterol 27-hydroxylase; 2-methylacyl-CoA racemase; and cholesterol 7α-hydroxylase.
Slovenian: Zaključil je, da ima zdravilo Kolbam koristne učinke za bolnike s pomanjkanjem naslednjih jetrnih encimov: sterol 27-hidroksilaze, 2-metilacil-CoA racemaze in holesterol 7hidroksilaze.
English: Kolbam is authorised for the life-long treatment of adults and children from one month of age who cannot produce enough primary bile acids such as cholic acid due to certain genetic abnormalities that result in a lack of the following liver enzymes: sterol 27-hydroxylase; 2-methylacyl-CoA racemase; or cholesterol 7α-hydroxylase.
Slovenian: Zdravilo Kolbam se uporablja za vseživljenjsko zdravljenje odraslih in otrok, starejših od enega meseca, ki zaradi genetskih nepravilnosti, katerih posledica je pomanjkanje jetrnih encimov sterol 27-hidroksilaze, 2-metilacil-CoA racemaze ali holesterol 7hidroksilaze niso zmožni tvoriti dovolj primarnih žolčnih kislin, kot je holna kislina.
English: The use of more than one of these products concomitantly should be avoided.
Slovenian: Sočasni uporabi več kot enega od teh zdravil se moramo izogibati.
English: Some patients who stop taking Xeristar suddenly have had symptoms such as:
Slovenian: Nekateri bolniki, ki so nenadoma prenehali jemati zdravilo Xeristar, so imeli simptome, kot so:
English: Sexual dysfunction
Slovenian: Spolna disfunkcija
English: These medicines increase the risk of side effects; if you get any unusual symptom taking any of these medicines together with Xeristar, you should see your doctor.
Slovenian: Ta zdravila povečajo tveganje za neželene učinke; če se pojavi kakršenkoli neobičajen simptom ob jemanju katerega od teh zdravil skupaj z zdravilom Xeristar, obiščite svojega zdravnika.
English: Component of a multipack, can't be sold separately.
Slovenian: Sestavni del večjega pakiranja, ni za ločeno prodajo.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit risk profile or as the result of an important (pharmacovililance or risk minimisation) milestone being reached.
Slovenian: • ob vsakršni spremembi sistema za obvladovanje tveganj, zlasti kadar je tovrstna sprememba posledica prejema novih informacij, ki lahko privedejo do znatne spremembe razmerja med koristmi in tveganji, ali kadar je ta sprememba posledica tega, da je bil dosežen pomemben mejnik (farmakovigilančni ali povezan z zmanjševanjem tveganja).
English: Date of first authorisation: 17 December 2004 Date of latest renewal: 24 June 2009
Slovenian: Datum podaljšanja dovoljenja za promet: 24. junij 2009
English: DO NOT stop taking your capsules without the advice of your doctor even if you feel better.
Slovenian: NE prenehajte jemati svojih kapsul, če vam ni tako svetoval vaš zdravnik, tudi če se bolje počutite.
English: Pregnancy There are no adequate data on the use of duloxetine in pregnant women.
Slovenian: Nosečnost Ustreznih podatkov o uporabi duloksetina pri nosečnicah ni.
English: Do not drive or use any tools or machines until you know how Xeristar affects you.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Ne vozite in ne upravljajte z orodji ali stroji, dokler ne veste, kako zdravilo Xeristar vpliva na vas.
English: Other psychiatric conditions for which Xeristar is prescribed can also be associated with an increased risk of suicide-related events.
Slovenian: Druga psihiatrična stanja, za katera predpisujemo zdravilo Xeristar so tudi lahko povezana z večjim tveganjem za pojav dogodkov povezanih s samomorom.
English: Talk to your doctor if you do not feel better after 2 months.
Slovenian: Posvetujte se s svojim zdravnikom, če se vaše počutje ne izboljša po dveh mesecih.
English: Age: Pharmacokinetic differences have been identified between younger and elderly females (≥65 years) (AUC increases by about 25% and half-life is about 25% longer in the elderly), although the magnitude of these changes is not sufficient to justify adjustments to the dose.
Slovenian: Starost: ugotavljali so farmakokinetične razlike med mlajšimi in starejšimi ženskami (≥ 65 let) (pri starejših se AUC poviša za približno 25 %, razpolovni čas pa je daljši za približno 25 %), vendar obseg teh sprememb ni tolikšen, da bi upravičil prilagajanje odmerka.
English: Taking a MAOI together with many prescription medicines, including Xeristar, can cause serious or even life-threatening side effects.
Slovenian: Jemanje MAOI skupaj z mnogimi zdravili na recept, vključno z zdravilom Xeristar, lahko povzroči resne ali celo smrtno nevarne neželene učinke.
English: • menopausal symptoms, abnormal production of breast milk in men or women
Slovenian: • menopavzalni simptomi, nenormalno nastajanje mleka v dojkah pri moških in ženskah
English: You should use Xeristar only after discussing the potential benefits and any potential risks to your unborn child with your doctor.
Slovenian: Zdravilo Xeristar lahko uporabljate le po tem, ko ste se o možnih koristih in morebitnih možnih tveganjih za vašega nerojenega otroka pogovorili s svojim zdravnikom.
English: Xeristar should be used in pregnancy only if the potential benefit justifies the potential risk to the foetus.
Slovenian: Zdravilo Xeristar naj se v nosečnosti uporablja le, če možna korist upravičuje možno tveganje za plod.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2. of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Slovenian: Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih posodobitvah RMP.
English: To help you remember to take Xeristar, you may find it easier to take it at the same times every day.
Slovenian: Morda se boste lažje spomnili vzeti zdravilo Xeristar, če jo boste jemali vsak dan ob isti uri.
English: ANNEX II
Slovenian: DODATEK III
English: What Xeristar is and what it is used for
Slovenian: Kaj je zdravilo Xeristar in za kaj ga uporabljamo
English: Distribution: Duloxetine is approximately 96% bound to human plasma proteins.
Slovenian: Porazdelitev: Duloksetin se veže na človeške plazemske beljakovine v približno 96 %.