FrancophonIA/ELRC3.0 huggingface dataset:
English: Simoctocog alfa is made by a method known as ‘recombinant DNA technology': it is made by cells into which a gene (DNA) has been introduced that makes them able to produce it.
Slovenian: Simoktokog alfa se proizvaja z metodo, imenovano „tehnologija rekombinantne DNK“, pri kateri ga izdelajo celice, v katere je bil vstavljen gen (DNK), ki jim omogoča tvorjenje tega faktorja.
English: The Agency decided that Nuwiq's benefits are greater than its risks and recommended that it be approved for use in the EU.
Slovenian: Agencija je menila, da so koristi zdravila Nuwiq večje od z njim povezanih tveganj, in priporočila, da se odobri za uporabo v EU.
English: Other information about Nuwiq
Slovenian: Druge informacije o zdravilu Nuwiq
English: Patients or their carers may be able to administer Nuwiq themselves at home once they have been trained appropriately.
Slovenian: Bolniki ali njihovi negovalci lahko po ustreznem usposabljanju zdravilo Nuwiq dajejo sami doma.
English: The dose and duration of treatment depend on whether Nuwiq is used to treat or prevent bleeding, or during surgery, as well as on the patient's factor VIII levels, the seriousness of the haemophilia, the extent and location of the bleeding and the patient's condition and bodyweight.
Slovenian: Odmerek in trajanje injiciranja sta odvisna od tega, ali se zdravilo Nuwiq uporablja za zdravljenje ali preprečevanje krvavitev, ali se uporablja med kirurškim posegom, kakor tudi od bolnikovih ravni faktorja VIII, resnosti hemofilije, obsega in mesta krvavitve ter bolnikovega stanja in telesne mase.
English: It contains the active substance simoctocog alfa (human coagulation factor VIII).
Slovenian: Vsebuje zdravilno učinkovino simoktokog alfa (humani koagulacijski faktor VIII).
English: For more information about treatment with Nuwiq, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Nuwiq preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Nuwiq have been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Nuwiq upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
English: What are the risks associated with Nuwiq?
Slovenian: Kakšna tveganja so povezana z zdravilom Nuwiq?
English: What benefits of Nuwiq have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Nuwiq izkazalo v študijah?
English: For the full list of all side effects and restrictions with Nuwiq, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Nuwiq glejte navodilo za uporabo.
English: What is Nuwiq and what is it used for?
Slovenian: Kaj je zdravilo Nuwiq in za kaj se uporablja?
English: When Nuwiq was used to prevent bleeding, an average of 0.34 bleeds per month was recorded for each child.
Slovenian: Kadar so zdravilo Nuwiq uporabljali za preprečevanje krvavitev, so pri vsakem otroku na mesec zabeležili povprečno 0,34 epizod krvavitve.
English: When used for treatment, bleeding episodes resolved in 81% of cases following one or two injections with Nuwiq.
Slovenian: Kadar so ga uporabljali za zdravljenje, so krvavitve v 81 % primerov obvladali z eno ali dvema injekcijama zdravila Nuwiq.
English: A total of 986 bleeding episodes were recorded, the majority of which resolved with one injection of Nuwiq.
Slovenian: Med študijo so zabeležili skupno 986 epizod krvavitve, od katerih so večino obvladali z eno injekcijo zdravila Nuwiq.
English: Nuwiq has been shown to be effective at preventing and treating bleeding episodes in three main studies involving 113 patients with haemophilia A.
Slovenian: Zdravilo Nuwiq se je izkazalo kot učinkovito pri preprečevanju in zdravljenju krvavitev v treh glavnih študijah, ki so vključevale 113 bolnikov s hemofilijo A.
English: When used to prevent bleeding, an average of 0.19 bleeds per month was recorded for each patient.
Slovenian: Kadar so zdravilo uporabljali za preprečevanje krvavitev, so pri vsakem bolniku zabeležili povprečno 0,19 epizod krvavitve na mesec.
English: The Agency concluded that Nuwiq has been shown to be effective at treating and preventing bleeding in patients with haemophilia A and has an acceptable safety profile.
Slovenian: Zaključila je, da se je zdravilo Nuwiq izkazalo za učinkovito pri zdravljenju in preprečevanju krvavenja pri bolnikih s hemofilijo A in da ima sprejemljiv varnostni profil.
English: Patients with haemophilia A lack factor VIII, and this causes blood clotting problems, such as bleeding in the joints, muscles or internal organs.
Slovenian: Bolnikom s hemofilijo A primanjkuje faktorja VIII, kar povzroča motnje strjevanja krvi, kot so krvavenje v sklepe, mišice ali notranje organe.
English: For practical information about using Nuwiq, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Nuwiq naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: Why is Nuwiq approved?
Slovenian: Zakaj je bilo zdravilo Nuwiq odobreno?
English: Nuwiq is used to correct the factor VIII deficiency by replacing the missing factor VIII, giving temporary control of the bleeding disorder.
Slovenian: Zdravilo Nuwiq se uporablja za uravnavanje pomanjkanja faktorja VIII, in sicer z nadomeščanjem manjkajočega faktorja VIII, kar vzpostavi začasni nadzor nad krvavitvami.
English: There is a risk with factor VIII medicines that some patients will develop inhibitors (antibodies) against factor VIII, causing the medicine to stop working and resulting in a loss of bleeding control.
Slovenian: Pri zdravilih s faktorjem VIII obstaja tveganje, da se bodo pri nekaterih bolnikih pojavili zaviralci (protitelesa) faktorja VIII, ki bodo izničili njegovo delovanje ter tako povzročili izgubo nadzora nad krvavitvijo.
English: The active substance in Nuwiq, simoctocog alfa (human coagulation factor VIII), is a substance that helps the blood to clot.
Slovenian: Zdravilna učinkovina v zdravilu Nuwiq, simoktokog alfa (humani koagulacijski faktor VIII), je snov, ki pripomore k strjevanju krvi.
English: For full details, see the package leaflet.
Slovenian: Za celotne informacije glejte navodilo za uporabo.
English: Nuwiq is a medicine used for the treatment and prevention of bleeding in patients of all ages with haemophilia A (an inherited bleeding disorder caused by lack of factor VIII).
Slovenian: Nuwiq je zdravilo, ki se uporablja za zdravljenje in preprečevanje krvavenja pri bolnikih s hemofilijo A (dedno motnjo strjevanja krvi, ki jo povzroča pomanjkanje faktorja VIII).
English: Nuwiq is available as a powder and solvent that are mixed together to make a solution for injection into a vein.
Slovenian: Zdravilo Nuwiq je na voljo v obliki praška in vehikla, ki se zmešata v raztopino za injiciranje v veno.
English: Hypersensitivity (allergic) reactions have been reported with factor VIII medicines and may in some cases become severe.
Slovenian: Pri uporabi zdravil, ki vsebujejo faktor VIII, so poročali o preobčutljivostnih (alergijskih) reakcijah, ki so lahko v nekaterih premerih resne.
English: It is not intended to provide practical advice on how to use Nuwiq.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: When used for the treatment of bleeding episodes, Nuwiq was mainly rated as ‘excellent' or ‘good' at treating major bleeding episodes and most bleeding episodes resolved following one or more injections of Nuwiq.
Slovenian: Kadar so zdravilo Nuwiq uporabljali za zdravljenje krvavitev, je bilo v glavnem ocenjeno kot „odlično“ ali „dobro“ za zdravljenje večjih krvavitev, večino krvavitev pa so obvladali z eno ali več injekcijami zdravila Nuwiq.
English: Treatment with Nuwiq was rated as ‘excellent' or ‘good' for 94% of bleeding episodes.
Slovenian: Zdravljenje z zdravilom Nuwiq so pri 94 % epizod krvavitve ocenili kot „odlično“ ali „dobro“.
English: In the two surgeries that occurred during the study, Nuwiq was rated as excellent in preventing bleeding episodes.
Slovenian: Pri dveh kirurških posegih, ki so jih opravili v času študije, je bilo zdravilo Nuwiq ocenjeno kot odlično za preprečevanje krvavitev.
English: Nuwiq can only be obtained with a prescription and treatment should be started under the supervision of a doctor experienced in the treatment of haemophilia.
Slovenian: Predpisovanje in izdaja zdravila Nuwiq je le na recept, zdravljenje z njim pa se sme uvesti in izvajati samo pod nadzorom zdravnika z izkušnjami z zdravljenjem hemofilije.
English: The first study involved 22 patients aged 12 years and above, who were given Nuwiq for the treatment of bleeding episodes or to prevent bleeding during surgery.
Slovenian: Prva študija je vključevala 22 bolnikov, starih 12 let in več, ki so prejeli zdravilo Nuwiq za zdravljenje krvavitev ali za preprečevanje krvavitve med kirurškim posegom.
English: In the five surgeries that occurred during the study, Nuwiq was rated as excellent in preventing bleeding episodes for four surgeries and as moderate to prevent bleeding during one surgical intervention.
Slovenian: Pri petih kirurških posegih, ki so jih opravili v času študije, je bilo zdravilo Nuwiq pri štirih kirurških posegih ocenjeno kot odlično za preprečevanje krvavitev, pri enem kirurškem posegu pa kot zmerno učinkovito za preprečevanje krvavitev.
English: The second study involved 32 patients aged 12 years and above who were given Nuwiq to prevent and treat bleeding events as well as to prevent bleeding during surgery.
Slovenian: Druga študija je vključevala 32 bolnikov, starih 12 let in več, ki so prejeli zdravilo Nuwiq za preprečevanje in zdravljenje krvavitev ter za preprečevanje krvavitve med kirurškim posegom.
English: How does Nuwiq work?
Slovenian: Kako zdravilo Nuwiq deluje?
English: How is Nuwiq used?
Slovenian: Kako se zdravilo Nuwiq uporablja?
English: The need for treatment should be reassessed regularly.
Slovenian: Potrebo po zdravljenju je treba redno ponovno ocenjevati.
English: However, juvenile rats are more sensitive.
Slovenian: Vendar pa so mlade podgane bolj občutljive.
English: This is different to the stresses and strains of everyday life.
Slovenian: To se razlikuje od stresa in obremenjenosti v vsakdanjem življenju.
English: In that case, just carry on with the next dose as normal.
Slovenian: V tem primeru nadaljujte z naslednjim odmerkom kot ponavadi.
English: The patient should be informed about this at the start of the treatment.
Slovenian: Bolnik mora biti s tem seznanjen na začetku zdravljenja.
English: Nine weeks after exposure, this effect was no longer observable.
Slovenian: 9 tednov po izpostavitvi tega učinka ni bilo več možno opaziti.
English: Do not take more medicine than prescribed.
Slovenian: Ne jemljite več zdravila, kot je predpisano.
English: • Inappropriate behaviour
Slovenian: • neprimerno vedenje
English: • Alcohol
Slovenian: • alkohol
English: If you forget to take a dose, take it as soon as you remember unless it is time for your next dose.
Slovenian: Če pozabite vzeti odmerek, ga vzemite takoj, ko se spomnite, razen če ni že čas za naslednjega.
English: Currently available data are described in section 4.8, 5.1 and 5.2 but no recommendation on a posology can be made.
Slovenian: Trenutno razpoložljivi podatki so opisani v poglavjih 4.8, 5.1 in 5.2, vendar ni mogoče dati priporočil o odmerjanju.
English: Interaction studies have only been performed in adults.
Slovenian: Študije medsebojnega delovanja so bile izvedene le pri odraslih.
English: • Slow or reduced movement of the body
Slovenian: • počasno ali okrnjeno gibanje telesa
English: The mechanism of this risk is not known and the available data do not exclude the possibility of an increased risk for pregabalin.
Slovenian: Mehanizem tega tveganja še ni znan in razpoložljivi podatki ne izključujejo možnosti povečanega tveganja pri uporabi pregabalina.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 25 June 2015
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum pridobitve dovoljenja: 25. junij 2015
English: Your doctor will determine what dose is appropriate for you.
Slovenian: Zdravnik bo določil primeren odmerek za vas.
English: Therefore the effects were considered of little or no clinical relevance.
Slovenian: Zato se vplivi smatrajo kot malo ali klinično nepomembni.
English: Pregabalin should be used with caution in these patients.
Slovenian: Pregabalin je treba pri takšnih bolnikih uporabljati previdno.
English: Following repeated administration, steady state is achieved within 24 to 48 hours.
Slovenian: Po večkratni uporabi je stanje dinamičnega ravnovesja doseženo v 24 do 48 urah.
English: Suicidal ideation and behaviour
Slovenian: Samomorilno razmišljanje in vedenje
English: Monotherapy (newly diagnosed patients)
Slovenian: Monoterapija (na novo diagnosticirani bolniki)
English: There is no evidence to suggest an associated risk to humans.
Slovenian: Ni podatkov, ki bi kazali na povezano tveganje za človeka.
English: After 3 months of treatment, there were no effects on sperm motility.
Slovenian: Po 3 mesecih zdravljenja, ni bilo vpliva na motiliteto sperme.
English: In juvenile rats the types of toxicity do not differ qualitatively from those observed in adult rats.
Slovenian: Pri mladih podganah se tipi toksičnosti ne razlikujejo kvalitativno od tistih, opaženih pri odraslih podganah.
English: Swallow the capsule whole with water.
Slovenian: Kapsulo pogoltnite celo z vodo.
English: Date of last renewal: DDMMYY
Slovenian: Datum zadnjega podaljšanja: DDMMLL
English: Mylan S.A.S 117 Allée des Parcs 69800 Saint-Priest France
Slovenian: Mylan S.A.S 117 Allée des Parcs 69800 Saint-Priest Francija
English: Single dose+
Slovenian: posamičen odmerek+
English: • Before taking this medicine you should tell your doctor if you have a history of alcoholism or any drug abuse or dependence.
Slovenian: • Pred uporabo tega zdravila morate svojemu zdravniku povedati, če ste imeli v preteklosti težave z alkoholizmom ali z zlorabo ali odvisnostjo od drog.
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Slovenian: O neželenih učinkih lahko poročate tudi neposredno na nacionalni center za poročanje, ki je naveden v Prilogi V. Stem, ko poročate o neželenih učinkih, lahko prispevate k zagotovitvi več informacij o varnosti tega zdravila.
English: Interactions and the elderly
Slovenian: Interakcije pri starejših
English: Dieselweg 25, 3752 LB Bunschoten The Netherlands
Slovenian: Dieselweg 25, 3752 LB Bunschoten Nizozemska
English: The safety and efficacy in children and adolescents (under 18 years of age) has not been established and therefore, pregabalin should not be used in this age group.
Slovenian: Varnost in učinkovitost pri otrocih in mladostnikih (mlajših od 18 let) nista ugotovljeni, zato se pregabalina v tej starostni skupini ne sme uporabljati.
English: • Difficulties with erection
Slovenian: • težave z erekcijo
English: If the dates for submission of a PSUR and the update of a RMP coincide, they can be submitted at the same time.
Slovenian: Če predložitev PSUR in posodobitev RMP sovpadata, se lahko predložita istočasno.
English: The marketing authorisation holder (MAH) shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Slovenian: • Redno posodobljena poročila o varnosti zdravila (PSUR) Imetnik dovoljenja za promet (MAH) z zdravilom mora redno posodobljena poročila o varnosti zdravila za to zdravilo predložiti v skladu z zahtevami, določenimi v seznamu referenčnih datumov Unije (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES in objavljenem na evropskem spletnem portalu o zdravilih.
English: Pregabalin Mylan Pharma should not be used during pregnancy unless clearly necessary (if the benefit to the mother clearly outweighs the potential risk to the foetus).
Slovenian: Zdravila Pregabalin Mylan Pharma se ne sme uporabljati med nosečnostjo, razen če je nujno potrebno (če koristi za mater jasno prevladajo nad možnim tveganjem za plod).
English: If you are an older patient (over 65 years of age), you should take Pregabalin Mylan Pharma normally except if you have problems with your kidneys.
Slovenian: Če ste starejši bolnik (nad 65 let), lahko jemljete zdravilo Pregabalin Mylan Pharma normalno, razen če imate težave z ledvicami.
English: The clinical relevance of these findings is unknown (see section 5.3).
Slovenian: Klinični pomen teh ugotovitev ni znan (glejte poglavje 5.3).
English: TID = Three divided doses
Slovenian: 3-krat/dan = tri deljene odmerke
English: Tell your doctor if you experience constipation, especially if you are prone to this problem.
Slovenian: Povejte zdravniku, če se pojavi zaprtost, še posebno, če ste nagnjeni k temu problemu.
English: INSTRUCTIONS ON USE <For multilayer label only> ‘Peel here'
Slovenian: NAVODILA ZA UPORABO <Samo za večplastne oznake> ‘Odlepi tukaj'
English: Pharmacotherapeutic group: Anti-epileptics, other anti-epileptics, ATC code: N03AX16.
Slovenian: Farmakoterapevtska skupina: antiepileptiki, drugi antiepileptiki, oznaka ATC: N03AX16.
English: • Take the number of capsules as instructed by your doctor.
Slovenian: • Vzemite toliko kapsul, kot vam je naročil zdravnik.
English: The effect of pregabalin on newborns/infants is unknown.
Slovenian: Učinek pregabalina na novorojenčke/dojenčke ni znan.
English: • Lorazepam - (used for treating anxiety)
Slovenian: • lorazepam - (uporablja se za zdravljenje tesnobe)
English: • Jaundice (yellowing of the skin and eyes).
Slovenian: • zlatenica (rumeno obarvanje kože in oči)
English: • Difficulty with or painful urination, incontinence
Slovenian: • težave z uriniranjem ali boleče uriniranje, inkontinenca
English: Therefore, you should be careful until you are used to any effect the medicine might have.
Slovenian: Zato bodite previdni, dokler se ne navadite na vse učinke, ki jih zdravilo lahko ima.
English: If you experience swollen face or tongue or if your skin turns red and starts to blister or peel you should seek immediate medical advice.
Slovenian: Če vam zateče obraz ali jezik ali če vaša koža postane rdeča in se na njej pojavijo mehurji ali se začne lupiti, morate nemudoma poiskati zdravniško pomoč.
English: Pregabalin mean elimination half-life is 6.3 hours.
Slovenian: Povprečni razpolovni čas izločanja pregabalina je 6,3 ure.
English: Pregabalin was not teratogenic in mice, rats or rabbits.
Slovenian: Pregabalin ni bil teratogen pri miših, podganah ali kuncih.
English: In preclinical studies, there was no indication of racemisation of pregabalin S-enantiomer to the R-enantiomer.
Slovenian: V predkliničnih raziskavah ni bilo znakov racemizacije S-enantiomera pregabalina v R-enantiomer.
English: The adverse reactions listed may also be associated with the underlying disease and/or concomitant medicinal products.
Slovenian: Našteti neželeni učinki so lahko povezani tudi z osnovno boleznijo in/ali sočasno uporabljenimi zdravili.
English: • The dose, which has been adjusted for you and your condition, will generally be between 150 mg and 600 mg each day.
Slovenian: • Odmerek, ki ga je prilagodil vam in vaši bolezni, bo praviloma med 150 mg in 600 mg na dan.
English: • Changes in the recording of electrical changes (ECG) in the heart which correspond to heart rhythm disturbances
Slovenian: • spremembe zapisa elektrokardiograma (EKG), ki kažejo na motnje srčnega ritma
English: A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Slovenian: PRILOGA II A. IZDELOVALEC (IZDELOVALCI), ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJ B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z ZDRAVILOM D. POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Slovenian: Preobčutljivost na učinkovino ali katerokoli pomožno snov, navedeno v poglavju 6.1.
English: • Increased appetite
Slovenian: • zvečanje apetita
English: In a clinical trial to assess the effect of pregabalin on sperm motility, healthy male subjects were exposed to pregabalin at a dose of 600 mg/day.
Slovenian: V kliničnem preskušanju za oceno vpliva pregabalina na motiliteto sperme, so bili zdravi moški izpostavljeni pregabalinu v odmerku 600 mg/dan.
English: • Difficulty with writing properly
Slovenian: • težave s pisanjem
English: Pregabalin and lamotrigine were similarly safe and well tolerated.
Slovenian: Pregabalin in lamotrigin sta si bila podobna glede varnosti in bolniki so ju enako dobro prenašali.
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Slovenian: Od zdravstvenih delavcev se zahteva, da poročajo o katerem koli neželenem učinku zdravila na nacionalni center za poročanje, ki je naveden v Prilogi V.
English: In table 2 below all adverse reactions, which occurred at an incidence greater than placebo and in more than one patient, are listed by class and frequency (very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data)).
Slovenian: V spodnji preglednici 2 so po organskih sistemih in pogostnosti navedeni vsi neželeni učinki, ki so se pojavili pri več kot enem bolniku in z incidenco, večjo kot pri placebu (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 pogostnost (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti)).
English: Women of childbearing potential/Contraception in males and females As the potential risk for humans is unknown, effective contraception must be used in women of child bearing potential.
Slovenian: Ženske v rodni dobi/Kontracepcija pri moških in ženskah Ker možno tveganje za ljudi ni znano, je pri ženskah v rodnem obdobju potrebna uporaba učinkovite kontracepcije.
English: • Painful menstrual periods
Slovenian: • boleče menstruacije
English: In humans, the apparent volume of distribution of pregabalin following oral administration is approximately 0.56 l/kg.
Slovenian: Pri človeku je navidezni volumen porazdelitve pregabalina po peroralni uporabi približno 0,56 l/kg.
English: Pregabalin pharmacokinetics in patients younger than 3 months old have not been studied (see sections 4.2, 4.8 and 5.1).
Slovenian: Farmakokinetike pregabalina niso preučevali pri bolnikih, mlajših od 3 mesecev (glejte poglavja 4.2, 4.8 in 5.1).
English: Pregabalin appears to be additive in the impairment of cognitive and gross motor function caused by oxycodone.
Slovenian: Kaže, da pregabalin aditivno prispeva k okvari kognitivnega in grobega motoričnega delovanja, ki jo povzroča oksikodon.
English: Inter-subject pharmacokinetic variability for pregabalin is low (<20%).
Slovenian: Razlike v farmakokinetiki pregabalina od posameznika do posameznika so majhne (< 20 %).
English: Pregabalin is not bound to plasma proteins.
Slovenian: Pregabalin ni vezan na beljakovine v plazmi.
English: Patients (and caregivers of patients) should be advised to seek medical advice should signs of suicidal ideation or behaviour emerge.
Slovenian: Bolnikom (in skrbnikom bolnikov) je treba svetovati, naj poiščejo zdravniško pomoč, če se pojavijo znaki samomorilnega razmišljanja in vedenja.