FrancophonIA/ELRC3.0 huggingface dataset:
English: If switching is not possible, the woman should receive further counselling regarding the valproate risks for the unborn child to support her informed decision making regarding family planning.
Slovenian: Če prehod ni mogoč, je treba ženski nuditi podporo pri informiranemu odločanju glede načrtovanja družine v obliki nadaljnjega svetovanja o tveganjih valproata za nerojenega otroka.
English: Further, an observational study to evaluate and identify the best practice for discontinuation and switching of valproate treatment will be conducted.
Slovenian: Poleg tega bo izvedena opazovalna študija za oceno in odkrivanje dobre prakse pri prekinitvi zdravljenja z valproatom in prehodom z valproata na drugo zdravilo.
English: To obtain additional robust information on the switch and discontinuation of valproate, the PRAC requested the conduct of an observational study to identify and evaluate the best practices for switching of valproate in clinical practice.
Slovenian: Da bi pridobil dodatne realne informacije o prehodu z valproata na druga zdravila ali prekinitvi uporabe valproata, je odbor PRAC zahteval izvedbo opazovalne študije za odkrivanje dobrih praks pri prehodu z valproata na druga zdravila v klinični praksi in za oceno teh praks.
English: • The PRAC considered that the pregnancy prevention programme should reflect that in the indication epilepsy, if a woman is planning to become pregnant, a specialist experienced in the management of epilepsy, must reassess valproate therapy and consider alternative treatment options.
Slovenian: • Odbor PRAC je menil, da mora program za preprečevanje nosečnosti pri indikaciji epilepsije izražati stališče, da mora strokovnjak, ki ima izkušnje z obravnavo epilepsije, pri ženski, ki načrtuje zanositev, znova oceniti zdravljenje z valproatom in razmisliti o drugih možnostih zdravljenja.
English: Indeed, the HCP guide will provide a reminder to the HCP of the conditions that apply for the administration of valproate (e.g. pregnancy prevention plan), the need to discuss the risks with the patient and check her pregnancy status.
Slovenian: Vodnik za zdravstvene delavce bo dejansko vseboval opomnik za zdravstvenega delavca o pogojih, ki veljajo za uporabo valproata (npr. načrt preprečevanja nosečnosti), o potrebi po pogovoru z bolnico o tveganjih in o preverjanju njenega stanja v zvezi z nosečnostjo.
English: The PRAC requested the conduct of postauthorisation studies.
Slovenian: Odbor PRAC je zahteval izvedbo študij po izdaji dovoljenja za promet z zdravilom.
English: The MAH requests CMDh to clarify the implementation of the PRAC outcome for injectable forms by further differentiating the routine/additional risk minimization activities to be considered for the noninjectable products and those also applicable to the injectable products.
Slovenian: Imetnik dovoljenja za promet z zdravilom prosi skupino CMDh, da pojasni uvajanje zaključka PRAC za farmacevtske oblike za injiciranje, tako da dodatno loči dejavnosti za zmanjševanje rutinskega/dodatnega tveganja, ki jih je treba upoštevati pri zdravilih, danih brez injiciranja, in tiste, ki veljajo tudi za zdravila, dana z injiciranjem.
English: The CMDh, as a consequence, considers that the benefit-risk balance of medicinal products containing substances related to valproate remains favourable subject to the amendments to the product information and to the conditions described above.
Slovenian: Skupina CMDh posledično meni, da je razmerje med tveganji in koristmi zdravil, ki vsebujejo valproatu sorodne snovi, še naprej ugodno, če se upoštevajo zgoraj opisane spremembe informacij o zdravilu in pogojev.
English: It can be concluded that it is extremely unlikely that valproate, when used by a male patient, could cause adverse effects to the embryo/foetus by this route.
Slovenian: Zaključiti je mogoče, da so neželeni učinki pri zarodku/plodu, ki bi jih po tej poti povzročil valproat, če ga uporablja bolnik moškega spola, zelo malo verjetni.
English: Choi CS, Gonzales EL, Kim KC, Yang SM, Kim JW, Mabunga DF, et al.
Slovenian: Choi CS, Gonzales EL, Kim KC, Yang SM, Kim JW, Mabunga DF, et al. The transgenerational inheritance of autism-like phenotypes in mice exposed to valproic acid during pregnancy.
English: Information on the patient card should be brief and concise regarding the efficacy of the product but also the harm to an unborn child when taken during pregnancy.
Slovenian: Informacije na kartici za bolnika glede učinkovitosti zdravila in škode za nerojenega otroka, če se zdravilo vzame med nosečnostjo, morajo biti kratke in natančne.
English: The Committee, as a consequence, recommends the variation to the terms of the marketing authorisations for medicinal products containing substances related to valproate.
Slovenian: Odbor je zato priporočil spremembo pogojev dovoljenj za promet z zdravili, ki vsebujejo valproatu sorodne snovi.
English: Regarding the visual reminder on the outer packaging, it is considered that it is crucial to remind to the HCPs that valproate should not be administered to women of childbearing potential (WCBP) who do not fulfil the pregnancy prevention plan requirements, or to pregnant patients, thus initiating a discussion about the risks of valproate with the patient.
Slovenian: Glede vizualnega opomnika na zunanji ovojnini velja, da je ključno opozorilo zdravstvenim delavcem, da valproata ne smejo dajati ženskam v rodni dobi, ki ne izpolnjujejo pogojev načrta za preprečevanje nosečnosti, ali nosečim bolnicam, in da se morajo pogovoriti z bolnico o tveganjih jemanja valproata.
English: For the female patients, there may be situations in which valproate treatment is initiated with the IV formulation (before discharge on valproate oral administration).
Slovenian: Pri bolnicah bo morda prišlo do situacij, pri katerih se bo zdravljenje z valproatom začelo s farmacevtsko obliko za injiciranje (pred prehodom na peroralno uporabo valproata).
English: • In addition, the PRAC recommended other changes to the product information such as warnings and precautions for use and updated information on the risks related to exposure during pregnancy to better inform the healthcare professionals and patients.
Slovenian: • Poleg tega je odbor PRAC za boljšo poučenost zdravstvenih delavcev in bolnikov priporočil druge spremembe informacij o zdravilu, kot so opozorila in previdnostni ukrepi za uporabo, ter posodobljene informacije o tveganjih, povezanih z izpostavljenostjo med nosečnostjo.
English: The annual risk acknowledgement form for injectable formulations of valproate and related substances containing products is intended to act as a periodic reminder and acknowledgement of the risks of valproate for women of childbearing potential (WCBP).
Slovenian: Obrazec za letno potrditev seznanjenosti s tveganjem za farmacevtske oblike zdravil za injiciranje, ki vsebujejo valproat in sorodne snovi, je namenjen rednemu opominjanju na tveganje valproata za ženske v rodni dobi in potrditvi seznanjenosti s tem tveganjem.
English: valproate indeed may induce transgenerational alterations of gene expression to the offspring and the types of consequent effects.
Slovenian: lahko sproži transgeneracijske spremembe izražanja genov pri potomcih in vrste posledičnih učinkov, potrebnih več raziskav.
English: Additionally, as the IV valproate formulations will likely be administered by different HCPs than the usual treating physicians, having a HCP guide in place for these products is crucial and therefore such HCP guide will also be provided to prescribers of IV formulation of valproate containing products.
Slovenian: Ker bodo farmacevtske oblike valproata za injiciranje najverjetneje dajali drugi zdravstveni delavci in ne lečeči zdravniki kot običajno, je poleg tega za zdravstvene delavce ključna vzpostavitev njim namenjenega vodnika za ta zdravila, zato bo a voljo tudi zdravstvenim delavcem, ki predpisujejo farmacevtske oblike zdravil za injiciranje, ki vsebujejo valproat.
English: Therefore, it is considered that the patient card is not required for injectable formulations products containing valproate and related substances.
Slovenian: Zato velja, da za farmacevtske oblike zdravil za injiciranje, ki vsebujejo valproat in sorodne snovi, kartica za bolnika ni potrebna.
English: The PRAC agrees that more research is necessary to evaluate whether
Slovenian: Odbor PRAC se strinja, da je za oceno, ali valproat res
English: A pregnancy prevention programme will be implemented accordingly to prevent valproate exposure during pregnancy given that significant risk of lifelong harm is associated with its use.
Slovenian: Ker je z uporabo valproata povezano znatno tveganje vseživljenjskih poškodb, bo ustrezno uveden program za preprečevanje nosečnosti, da se prepreči izpostavljenost valproatu med nosečnostjo.
English: In view of the above, the Committee considers that the benefit-risk balance of medicinal products containing substances related to valproate remains favourable subject to the agreed conditions to the marketing authorisations, and taking into account the agreed amendments to the product information and other risk minimisation measures.
Slovenian: Glede na navedeno odbor meni, da je ob upoštevanju dogovorjenih pogojev za dovoljenja za promet z zdravilom ter dogovorjenih sprememb informacij o zdravilu in drugih ukrepov za zmanjševanje tveganj razmerje med tveganji in koristmi zdravil, ki vsebujejo valproatu sorodne snovi, še naprej ugodno.
English: In addition, the guide should familiarise the prescribers with key actions to mitigate the risks associated with the use of valproate in exposed girls and women by using the patient guide and the risk acknowledgment form.
Slovenian: Poleg tega mora vodnik prek vodnika za bolnike in obrazca za potrditev seznanjenosti s tveganjem seznaniti predpisovalce s ključnimi dejavniki za zmanjševanje tveganj, povezanih z uporabo valproata pri izpostavljenih deklicah in ženskah.
English: At least annual re-assessment of the need for valproate therapy and consideration of alternative treatment options in female children who experienced menarche and women of childbearing potential should be included.
Slovenian: Pri deklicah, pri katerih se je že pojavila menarha, in pri ženskah v rodni dobi je treba vključiti vsaj letno ponovno oceno potrebe po zdravljenju z valproatom in premislek o drugih možnostih zdravljenja.
English: Consequently, the annual risk acknowledgment form is not required for the injectable formulations.
Slovenian: Ta obrazec zato za farmacevtske oblike za injiciranje ni potreben.
English: Educational measures are necessary in order to ensure that healthcare professionals and patients are informed about the risks associated with valproate in http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/referrals/Valproate_and_related_substa nces/human_referral_prac_000032.jsp&mid=WC0b01ac05805c516f pregnant women and women of childbearing potential and on the measures necessary to minimise the risk of exposure on valproate in pregnancy.
Slovenian: Da bodo zdravstveni delavci in bolniki poučeni o tveganjih, povezanih z uporabo valproata pri nosečih ženskah in ženskah v rodni dobi, ter o ukrepih, ki so potrebni, da je tveganje izpostavljenosti valproatu v nosečnosti čim manjše, so potrebni izobraževalni ukrepi.
English: A post-authorisation safety study (PASS) using data preferably from existing registries should be performed to further characterise the foetal anticonvulsant syndrome in children with valproate in utero exposure as compared to other anti-epileptic drugs.
Slovenian: Za dodatno opredelitev antikonvulzivnega sindroma pri plodu pri otrocih, izpostavljenih valproatu in utero, je treba izvesti varnostno študijo po izdaji dovoljenja za promet z zdravilom (PASS), pri čemer je treba po možnosti uporabiti podatke iz obstoječih evidenc.
English: Usage data from the ongoing joint drug utilisation study (DUS) as well as other data (surveys, national surveys, anecdotal evidence etc.) that have been evaluated in the current referral indicate that valproate is still used by a considerable proportion of WCBP in different MSs for both epilepsy and bipolar disorder indications.
Slovenian: Podatki o uporabi iz študije o uporabi zdravil (DUS), ki še poteka, in drugi podatki (raziskave, nacionalne raziskave, anekdotični dokazi idr.
English: EU/1/01/177/002 SonoVue
Slovenian: EU/1/01/177/002
English: solvent: 5 ml
Slovenian: Vehikel: 5 ml
English: Powder and solvent for dispersion for injection
Slovenian: Prašek in vehikel za disperzijo za injiciranje
English: Immediate Packaging
Slovenian: velikost pakiranja
English: 1 vial + 1 pre-filled syringe + 1 'MiniSpike' rec. device
Slovenian: 1 viala + 1 napolnjena injekcijska brizga + ločen MiniSpike sistem za prenos
English: Intravenous use, Intravesical use powder: vial (glass); solvent: pre-filled syringe (glass)
Slovenian: Prašek: viala (steklo) Vehikel: napolnjena injekcijska brizga (steklo)
English: MA (EU) number (Invented) name
Slovenian: Številka EU
English: Pack size
Slovenian: SonoVue
English: Strength Pharmaceutical Form
Slovenian: zaščiteno ime jakost farmacevtska oblika pot uporabe ovojnina vsebina (koncentracija)
English: (× 0.85 for female patients)
Slovenian: (× 0,85 za bolnice)
English: normally except if you have problems with your kidneys.
Slovenian: normalno, razen če imate težave z ledvicami.
English: is not intended to be used alone, but should always be used in combination with other anti-epileptic treatment.
Slovenian: ni namenjeno temu, da bi ga jemali samo, temveč ga je vedno treba uporabljati v kombinaciji z drugimi zdravili proti epilepsiji.
English: and certain other medicines may influence each other (interaction).
Slovenian: in določena druga zdravila imajo lahko medsebojno delovanje (interakcije).
English: Currently available data are described in sections 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: • alcohol.
Slovenian: • alkohol
English: + Supplementary dose is a single additional dose.
Slovenian: + Dodaten odmerek je posamičen dopolnilni odmerek.
English: may be taken with or without food.
Slovenian: se lahko jemlje s hrano ali brez nje.
English: B-dul Theodor Pallady nr.50, sector 3, Bucharest, cod 032266 Romania
Slovenian: B-dul Theodor Pallady nr.50, sector 3, Bucharest, cod 032266 Romunija
English: until your doctor tells you to stop.
Slovenian: jemljite, dokler vam zdravnik ne naroči, da nehajte.
English: You can also report any 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. S tem, ko poročate o neželenih učinkih, lahko prispevate k zagotovitvi več informacij o varnosti tega zdravila.
English: either twice or three times a day.
Slovenian: morate vzeti dvakrat ali trikrat na dan.
English: Pregabalin 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 Zentiva se ne sme uporabljati med nosečnostjo, razen če je nujno potrebno (če koristi za mater jasno prevladajo nad možnim tveganjem za plod).
English: ANNEX II 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: If you are an elderly patient (over 65 years of age), you should take Pregabalin Zentiva k.s.
Slovenian: Če ste starejši bolnik (nad 65 let), lahko jemljete zdravilo Pregabalin Zentiva k.s.
English: • if you are allergic to pregabalin or any of the other ingredients of this medicine (listed in section
Slovenian: • če ste alergični na pregabalin ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: Elevated liver enzymes*
Slovenian: Zvišane vrednosti jetrnih encimov*
English: Angioedema, allergic reaction
Slovenian: Angioedem, alergična reakcija
English: CLcr (ml/min) =
Slovenian: OČkr (ml/min) =
English: is used to treat long lasting pain caused by damage to the nerves.
Slovenian: se uporablja za zdravljenje dolgotrajne bolečine, nastale zaradi okvare živcev.
English: contains lactose monohydrate If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Slovenian: vsebuje laktozo monohidrat Če vam je zdravnik povedal, da imate intoleranco za nekatere sladkorje, se pred uporabo tega zdravila posvetujte s svojim zdravnikom.
English: Pharmacotherapeutic group: Anti-epileptics, other anti-epileptics; ATC code: N03AX16.
Slovenian: Farmakoterapevtska skupina: antiepileptiki, drugi antiepileptiki, oznaka ATC: N03AX16.
English: Do not store above 30 °C.
Slovenian: Shranjujte pri temperaturi do 30°C.
English: 1.23 × [140 - age (years)] × weight (kg) serum creatinine (µmol/l)
Slovenian: 1,23 × [140 - starost (leta)] × masa (kg) Kreatinin v serumu (µmol/l)
English: • lorazepam (used for treating anxiety).
Slovenian: • lorazepam (uporablja se za zdravljenje tesnobe)
English: may be taken with oral contraceptives.
Slovenian: lahko jemljete s peroralnimi kontraceptivi.
English: is for oral use only.
Slovenian: je samo za peroralno uporabo.
English: hard capsules regularly at the same time each day.
Slovenian: jemljete redno, vsak dan ob istem času.
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: should not be taken during pregnancy or when breast-feeding, unless you are told otherwise by your doctor.
Slovenian: ne smete uporabljati med nosečnostjo ali dojenjem, razen če vam tako svetuje zdravnik.
English: Very common: may affect more than 1 in 10 people • Dizziness, drowsiness, headache.
Slovenian: Zelo pogosti: pojavijo se lahko pri več kot 1 od 10 bolnikov • omotica, zaspanost, glavobol
English: DATE OF FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION Date of first authorisation: 27 February 2017.
Slovenian: Datum prve pridobitve: 27. februar 2017
English: you notice decreased urination, you should tell your doctor as stopping the medicine may improve this.
Slovenian: zasledite zmanjšano izločanje urina, morate to povedati zdravniku, saj se lahko s prenehanjem jemanja zdravila stanje izboljša.
English: These symptoms may occur more commonly or severely if you have been taking pregabalin for a longer period of time.
Slovenian: Ti znaki se lahko pojavljajo bolj pogosto in z večjo izrazitostjo, če ste pregabalin jemali daljši čas.
English: SPECIAL STORAGE CONDITIONS Do not store above 30 °C.
Slovenian: POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte pri temperaturi do 30°C.
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 (ni mogoče oceniti iz razpoložljivih podatkov)).
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, prilagojen vam in vaši bolezni, bo praviloma med 150 mg in 600 mg na dan.
English: The rate of pregabalin absorption is decreased when given with food resulting in a decrease in Cmax by approximately 25 - 30% and a delay in tmax to approximately 2.5 hours.
Slovenian: Hitrost absorpcije pregabalina se zmanjša, če je uporabljen s hrano; Cmax se zmanjša za približno 25-30 % in tmax se podaljša na približno 2,5 ure.
English: Printing ink
Slovenian: Tiskarsko črnilo
English: 25 mg hard capsules are packed into alu/alu (OPA/alu/PVC/alu) blisters as primary packaging.
Slovenian: 25 mg trde kapsule so pakirane v alu/alu (OPA/alu/PVC/alu) pretisnih omotih kot primarni ovojnini.
English: • A small number of people being treated with anti-epileptics such as pregabalin have had thoughts of harming or killing themselves.
Slovenian: • Pri majhnem številu bolnikov, ki so se zdravili z antiepileptiki, kot je pregabalin, so se pojavile misli na samopoškodovanje ali samomor.
English: Peripheral and central neuropathic pain, epilepsy or generalised anxiety disorder Take the number of hard capsules as instructed by your doctor.
Slovenian: Periferna in centralna nevropatska bolečina, epilepsija ali generalizirana anksiozna motnja Vzemite toliko trdih kapsul, kot vam je naročil zdravnik.
English: Patients with rare hereditary problems of galactose intolerance, the total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Slovenian: Bolniki z redko dedno intoleranco za galaktozo, odsotnostjo encima laktaze ali malabsorpcijo glukoze/galaktozene smejo jemati tega zdravila.
English: You should not drive, operate complex machinery or engage in other potentially hazardous activities until you know whether this medicine affects your ability to perform these activities.
Slovenian: Ne vozite, ne upravljajte zapletenih strojev in ne sodelujte pri drugih potencialno nevarnih dejavnostih, dokler ne veste, ali to zdravilo poslabša vašo zmožnost za takšne dejavnosti.
English: The active substance, pregabalin, is a gamma-aminobutyric acid analogue [(S)-3-(aminomethyl)-5methylhexanoic acid].
Slovenian: Učinkovina pregabalin je analog gama-aminomaslene kisline [(S)-3-(aminometil)-5- metilheksanojska kislina].
English: Infections and infestations Common
Slovenian: Infekcije in okužbe Pogosti
English: is used to treat a certain form of epilepsy (partial seizures with or without secondary generalisation) in adults.
Slovenian: se uporablja za zdravljenje določene oblike epilepsije (parcialnih napadov s sekundarno generalizacijo ali brez nje) pri odraslih.
English: The safety and efficacy of pregabalin in children below the age of 12 years and in adolescents (12 - 17 years of age) have not been established.
Slovenian: Varnost in učinkovitost pregabalina pri otrocih, starih do 12 let, in pri mladostnikih (12-17 let) nista bili dokazani.
English: In accordance with current clinical practice, if pregabalin has to be discontinued it is recommended this should be done gradually over a minimum of 1 week independent of the indication (see sections 4.4 and 4.8).
Slovenian: Če je treba uporabo pregabalina prekiniti, ga je skladno s trenutno klinično prakso, ne glede na indikacijo, priporočljivo zmanjševati postopoma vsaj 1 teden (glejte poglavji 4.4 in 4.8).
English: is too strong or too weak, talk to your doctor or pharmacist.
Slovenian: premočan ali prešibak, se posvetujte z zdravnikom ali farmacevtom.
English: Pregabalin binds to an auxiliary subunit (α2-δ protein) of voltage-gated calcium channels in the central nervous system.
Slovenian: Pregabalin se veže na pomožno podenoto (beljakovino α2-δ) napetostno odvisnih kalcijevih kanalčkov v osrednjem živčevju.