FrancophonIA/ELRC3.0 huggingface dataset:
English: Life-threatening hypersensitivity reactions are reported very rarely.
Slovenian: O življenjsko nevarnih preobčutljivostnih reakcijah so poročali zelo redko.
English: In vitro experiments in human liver microsomes and human hepatocytes did not suggest significant inhibition or induction of other CYP isoenzymes (CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP1A2, CYP3A4).
Slovenian: In vitro poskusi na humanih jetrnih mikrosomih in humanih hepatocitih niso pokazali značilnega zaviranja ali indukcije drugih izoencimov CYP (CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP1A2, CYP3A4).
English: Patients should be advised to remain vigilant for any symptoms compatible with hypersensitivity and to stop tolperisone and seek medical advice immediately if such symptoms occur.
Slovenian: Bolnikom je treba svetovati, da so pozorni za kakršne koli simptome, ki so združljivi s preobčutljivostjo in da takoj prenehajo jemati tolperizon ter poiščejo zdravniško pomoč, če se pojavi kateri od tovrstnih simptomov.
English: [the wording below should be deleted, as relevant] No hypersensitivity case with fatal outcome after tolperisone treatment has been registered.
Slovenian: [treba je izbrisati naslednje besedilo, kot je primerno] Primera preobčutljivosti s smrtnim izidom po zdravljenju s tolperizonom niso zabeležili.
English: Early signs of hypersensitivity are: flushing, rash, severe itching of the skin (with raised lumps), wheezing, difficulty in breathing with or without swelling of the face, lips, tongue and/or throat, difficulty in swallowing, fast heart beat, low blood pressure, fast decrease in blood pressure.
Slovenian: Zgodnji znaki preobčutljivosti so: rdečica, izpuščaj, hudo srbenje kože (z izboklimi oteklinami), sopenje, težave z dihanjem z ali brez otekanja obraza, ustnic, jezika in/ali grla, težave s požiranjem, hiter srčni utrip, nizek krvni tlak, nagel padec krvnega tlaka.
English: Therefore the preparation can be combined with sedatives, hypnotics and tranquillisers.
Slovenian: Zato je možno zdravilo kombinirati z drugimi sedativi, hipnotiki in pomirjevali.
English: Annex III Relevant sections of the summary of product characteristics and package leaflet
Slovenian: PRILOGA III USTREZNA POGLAVJA POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA IN NAVODILA ZA UPORABO
English: In post-marketing data, hypersensitivity reactions associated with tolperisone administration account for about 50-60% of the reported cases.
Slovenian: V podatkih iz obdobja trženja predstavljajo preobčutljivostne reakcije, povezane z dajanjem tolperizona, 50 - 60 % delež primerov, o katerih so poročali.
English: If you are allergic to the active substance (tolperisone hydrochloride) or to medicines containing eperisone or any of the other ingredients of this medicine (listed in section 6).
Slovenian: Če ste alergični na zdravilno učinkovino (tolperizonijev klorid) ali zdravila, ki vsebujejo eperizon ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: 4.7 Effects on ability to drive and use machines [the wording below should be inserted]
Slovenian: 4.7 Vpliv na sposobnost vožnje in upravljanja s stroji [treba je vstaviti naslednje besedilo]
English: Very rare side effects …confusion, severe allergic reaction (allergic shock)
Slovenian: Zelo redki neželeni učinki …zmedenost, huda alergijska reakcija (alergijski šok)
English: If you have a known allergy for lidocaine you have a higher risk to be allergic to tolperisone.
Slovenian: Če imate znano alergijo na lidokain, obstaja večja verjetnost, da ste alergični na tolperizon.
English: High-fat meal increases the bioavailability of orally administered tolperisone by approx. 100% and increases the peak plasma concentration by approx. 45% as compared with fasting condition, delaying time to peak by approx. 30 minutes.
Slovenian: Obrok z veliko vsebnostjo maščob poveča biološko uporabnost peroralno danega tolperizona za približno 100 % in poveča plazemsko koncentracijo za približno 45 %, v primerjavi s pogoji na tešče, ter odloži čas največje plazemske koncentracije za približno 30 minut.
English: Symptoms may include erythema, rash, urticaria, pruritus, angioedema, tachycardia, hypotension or dyspnoea.
Slovenian: Simptomi lahko vključujejo eritem, izpuščaj, urtikarijo, pruritus, angioedem, tahikardijo, hipotenzijo in dispnejo.
English: Although tolperisone is a centrally acting compound, it does not induce sedation.
Slovenian: Kljub temu, da je tolperizon osrednje delujoča spojina, ne sproža sedacije.
English: confusion (very rare), hyperhidrosis (rare)
Slovenian: zmedenost (zelo redki), čezmerno znojenje (redki)
English: In case of a known hypersensitivity to lidocaine increased caution during the administration of tolperisone because of possible cross-reactions is warranted.
Slovenian: V primeru znane preobčutljivosti na lidokain je med dajanjem tolperizona potrebna večja previdnost zaradi možnih navzkrižnih reakcij.
English: In the case of co-administration with other centrally acting muscle relaxants, the dose reduction of tolperisone should be considered.
Slovenian: V primeru sočasnega dajanja z drugimi osrednje delujočimi mišičnimi relaksanti, je treba razmisliti o zmanjšanju odmerka tolperizona.
English: According to these data, the most frequently concerned system organ classes are skin and subcutaneous tissue disorders, general disorders, neurological disorders and gastrointestinal disorders.
Slovenian: Po teh podatkih so najpogosteje obravnavani organski sistemi bolezni kože in podkožja, splošne težave, bolezni živčevja in bolezni prebavil.
English: Hypersensitivity to the active substance tolperisone or to the chemically similar eperisone or to any of the excipients listed in section 6.1.
Slovenian: Preobčutljivost na zdravilno učinkovino tolperizon ali kemijsko podoben eperizon ali katero koli pomožno snov, navedeno v poglavju 6.1.
English: Symptomatic treatment of post-stroke spasticity in adults.
Slovenian: simptomatsko zdravljenje spastičnosti po možganski kapi pri odraslih.
English: Rare side effects …increased sweating
Slovenian: Redki neželeni učinki …čezmerno znojenje
English: Pharmacokinetic drug interaction studies with the CYP2D6 substrate dextromethorphan indicate that tolperisone co-administration may increase the blood levels of drugs which are metabolised dominantly by CYP2D6 such as thioridazine, tolterodine, venlafaxine, atomoxetine, desipramine, dextromethorphan, metoprolol, nebivolol, perphenazine.
Slovenian: Farmakokinetične študije medsebojnega delovanja z drugimi zdravili, in sicer z dekstrometorfanom, ki je substrat CYP2D6, nakazujejo, da sočasno dajanje s tolperizonom lahko poveča koncentracijo učinkovin, ki se presnavljajo predvsem s CYP2D6, kot so tioridazin, tolterodin, venlafaksin, atomoksetin, desipramin, dekstrometorfan, metoprolol, nebivolol, perfenazin.
English: Tolperisone potentiates the effect of niflumic acid, therefore reduction of the dose of niflumic acid or other NSAID should be considered in case of co-administration.
Slovenian: Tolperizon ojača učinek niflumske kisline, zato je v primeru sočasnega dajanja treba razmisliti o zmanjšanju odmerka niflumske kisline ali drugega nesteroidnega protivnetnega zdravila (NSAID).
English: Females, patients in older age, or treated with concomitant medications (mainly with NSAIDs) seem to be at a higher risk to experience hypersensitivity reactions.
Slovenian: Pri ženskah, starejših bolnikih ali tistih, ki se sočasno zdravijo z drugimi zdravili (zlasti z nesteroidnimi protivnetnimi zdravili (NSAID)), obstaja večje tveganje za pojav preobčutljivostnih reakcij.
English: Although tolperisone is a centrally acting compound, its potential to cause sedation is low.
Slovenian: Čeprav je tolperizon spojina z osrednjim delovanjem, je možnost, da bi povzročil sedacijo, majhna.
English: Tolperisone must not be re-administered after an episode of hypersensitivity to tolperisone.
Slovenian: Tolperizona ne smemo ponovno dajati po epizodi preobčutljivosti na tolperizon.
English: Females, patients with hypersensitivity to other drugs or with a history of allergy may be at a higher risk.
Slovenian: Pri ženskah, bolnikih s preobčutljivostjo na druga zdravila ali alergijo v anamnezi je tveganje večje.
English: If you have severe liver problems you should not take this medicine.
Slovenian: Če imate hude težave z ledvicami, tega zdravila ne smete jemati.
English: If you have ever had allergic reaction to tolperisone you must not use this medicine.
Slovenian: Če ste kadar koli imeli alergijsko reakcijo na tolperizon, ne smete jemati tega zdravila.
English: It is for the treatment of the pathologically elevated skeletal muscle tone after a stroke in adults.
Slovenian: Uporablja se pri odraslih za zdravljenje bolezensko povečanega tonusa skeletnih mišic po možganski kapi.
English: Paediatric population The safety and efficacy of tolperisone in children have not been established.
Slovenian: Pediatrična populacija Varnost in učinkovitost tolperizona pri otrocih nista bili dokazani.
English: Patients who experience dizziness, somnolence, disturbance in attention, epilepsy, blurred vision or muscular weakness while taking tolperisone should consult his/her doctor.
Slovenian: Bolniki, pri katerih se med jemanjem tolperizona pojavi omotica, somnolenca, motnja pozornosti, epilepsija, zamegljen vid ali mišična šibkost, se morajo posvetovati s svojim zdravnikom.
English: Hypersensitivity reactions ranged from mild skin reactions to severe systemic reactions including anaphylactic shock.
Slovenian: Preobčutljivostne reakcije so obsegale tako blage kožne reakcije kot hude sistemske reakcije vključno z anafilaktičnim šokom.
English: Children and adolescents The safety and efficacy of tolperisone in children have not been established.
Slovenian: Otroci in mladostniki Varnost in učinkovitost tolperizona pri otrocih nista bili dokazani.
English: Use of tolperisone is not recommended in patients with severe renal impairment.
Slovenian: Uporaba tolperizona ni priporočljiva pri bolnikih s hudo okvaro ledvic.
English: Hypersensitivity reactions ranged from mild skin reactions to severe systemic reactions (e.g. allergic shock).
Slovenian: Preobčutljivostne reakcije so bile tako blage kožne reakcije kot resne sistemske reakcije (npr. alergijski šok).
English: SUMMARY OF PRODUCT CHARACTERISTICS (TOLPERISONE-CONTAINING ORAL FORMULATIONS)
Slovenian: POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA (PERORALNE FARMACEVTSKE OBLIKE, KI VSEBUJEJO TOLPERIZON)
English: Your regular medical follow-up will include frequent monitoring of kidney function and your condition during therapy with {invented name} because a higher frequency of adverse events has been observed in this patient group.
Slovenian: Vaš redni zdravniški nadzor bo vključeval pogosto spremljanje delovanja ledvic in vašega stanja med zdravljenjem z zdravilom {Izmišljeno ime zdravila}, ker so pri tovrstni skupini bolnikov zabeležili večjo pogostost pojavljanja neželenih učinkov.
English: Use of tolperisone is not recommended in patients with severe hepatic impairment.
Slovenian: Uporaba tolperizona ni priporočljiva pri bolnikih s hudo okvaro jeter.
English: Increase in tolperisone exposure is not expected after concomitant administration of CYP2D6 substrates and/or other drugs due to the diversity of the metabolic pathways of tolperisone.
Slovenian: Zaradi raznolikosti presnovnih poti tolperizona ni pričakovati povečanja izpostavljenosti tolperizonu po sočasnem dajanju s substrati CYP2D6 in/ali drugimi učinkovinami.
English: Use in children and adolescents The safety and efficacy of Tolperisone in children have not been established.
Slovenian: Uporaba pri otrocih in mladostnikih Varnost in učinkovitost tolperizona pri otrocih nista bili dokazani.
English: If you experience dizziness, somnolence, disturbance in attention, epilepsy, blurred vision or muscular weakness while taking {invented name} consult your doctor.
Slovenian: Če se med jemanjem zdravila {Izmišljeno ime zdravila} pri vas pojavi omotica, bolezenska zaspanost, motnja pozornosti, epilepsija, zamegljen vid ali mišična šibkost, se posvetujte z zdravnikom.
English: 4.2 Posology and method of administration [the wording below should be inserted]
Slovenian: 4.2 Odmerjanje in način uporabe [treba je vstaviti naslednje besedilo]
English: Your regular medical follow-up will include frequent monitoring of liver function and your condition during therapy with Tolperisone because a higher frequency of adverse events has been observed in this patient group.
Slovenian: Vaš redni zdravniški nadzor bo vključeval pogosto spremljanje delovanja jeter in vašega stanja med zdravljenjem z zdravilom {Izmišljeno ime zdravila}, ker so pri tovrstni skupini bolnikov zabeležili večjo pogostost pojavljanja neželenih učinkov.
English: How to take Tolperisone film-coated tablet
Slovenian: Kako jemati zdravilo {Izmišljeno ime zdravila}
English: Experience in patients with renal impairment is limited and a higher frequency of adverse events has been observed in this patient group.
Slovenian: Izkušenj pri bolnikih z okvaro ledvic je malo in v tej skupini bolnikov so opazili večjo pogostnost pojavljanja neželenih učinkov.
English: During post marketing experience with tolperisone the most frequently reported adverse reactions were hypersensitivity reactions.
Slovenian: V obdobju trženja zdravila so bili najpogosteje poročani neželeni učinki preobčutljivostne reakcije.
English: PACKAGE LEAFLET (TOLPERISONE-CONTAINING ORAL FORMULATIONS) [the wording below should be inserted in the relevant sections]
Slovenian: NAVODILO ZA UPORABO (PERORALNE FARMACEVTSKE OBLIKE, KI VSEBUJEJO TOLPERIZON) [v ustrezna poglavja je treba vstaviti naslednje besedilo]
English: During post marketing experience with medicinal products containing tolperisone (the active substance of {invented name}) the most frequently reported side effects were hypersensitivity reactions.
Slovenian: V obdobju trženja zdravil, ki vsebujejo tolperizon (zdravilna učinkovina v zdravilu {Izmišljeno ime zdravila} so kot o najpogostejših neželenih učinkih poročali o preobčutljivostnih reakcijah.
English: Therefore, individual titration with close monitoring of the patient's condition and renal function is recommended in patients with moderate renal impairment.
Slovenian: Zato je pri bolnikih z zmerno okvaro ledvic priporočljiva individualna titracija s skrbnim spremljanjem bolnikovega stanja in delovanja ledvic.
English: Therefore, individual titration with close monitoring of the patient's condition and hepatic function is recommended in patients with moderate hepatic impairment.
Slovenian: Zato je pri bolnikih z zmerno okvaro jeter priporočljiva individualna titracija s skrbnim spremljanjem bolnikovega stanja in delovanja jeter.
English: Also, patients with drug allergy or allergic diseases or conditions (such as atopy: hay fever, asthma, atopic dermatitis with high serum
Slovenian: Prav tako kaže, da obstaja pri bolnikih z alergijami na zdravila ali alergijskimi boleznimi ali stanji (kot so atopija, seneni nahod, astma, atopični dermatitis z veliko vrednostjo IgE v krvi, urtikarija) v anamnezi ali pri tistih, ki imajo sočasno prisotno virusno okužbo, večje tveganje za pojav alergijske reakcije na to zdravilo.
English: However, the analyses are based on a limited number of women, especially in the highest body weight/BMI categories, which subsequently result in very wide and overlapping 95% confidence limits.
Slovenian: Vendar so analize temeljile na omejenem številu žensk, zlasti v skupinah z največjimi telesnimi masami/najvišjimi ITM, kar je povzročilo zelo široke in prekrivajoče se meje 95odstotnega intervala zaupanja.
English: The data used in the analyses of effect of UPA in relation to weight/BMI are partly based on the same studies two abovementioned studies for LNG, and another randomised controlled study (HRA2914-507, HRA2914-508, HRA2914-513) as well as an open label study (HRA2914-509).
Slovenian: Podatki, ki so bili uporabljeni v analizah učinka UPA glede na telesno maso/ITM, delno temeljijo na istih dveh študijah, ki sta opisani zgoraj za LNG, ter na še eni randomizirani kontrolirani študiji (HRA2914-507, HRA2914-508, HRA2914-513) in eni odprti študiji (HRA2914-509).
English: Annex IV Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
Slovenian: Znanstveni zaključki in podlaga za spremembo pogojev dovoljenj za promet z zdravili
English: Both meta-analyses excluded intake later than 72 hours after unprotected intercourse (i.e. offlabel use of LNG) and women who had further acts of unprotected intercourse.
Slovenian: Iz obeh metaanaliz so bili izključeni vnosi več kot 72 ur po nezaščitenem spolnem odnosu (tj. nenamenska uporaba LNG) in ženske, ki so imele nadaljnje nezaščitene spolne odnose.
English: All together, the current data are considered not robust enough to support the current recommendation of decreased efficacy in women with body weight above 75 kg and inefficacy in women with body weight above 80 kg as is currently included in the product information of one
Slovenian: Na splošno je bilo ocenjeno, da trenutni podatki niso dovolj prepričljivi, da bi lahko podprli sedanjo navedbo o manjši učinkovitosti pri ženskah s telesno maso več kot 75 kg in neučinkovitosti pri ženskah s telesno maso več kot 80 kg, ki je trenutno vključena v informacije o zdravilu za enega od urgentnih kontraceptivov, ki vsebujejo LNG (Norlevo).
English: Table 1: Meta-analysis on three WHO studies (Von Hertzen et al., 1998 and 2002; Dada et al.,
Slovenian: Razpredelnica 1: Metaanaliza treh študij SZO (Von Hertzen et al., 1998 in 2002; Dada et al., 2010)
English: Further, the data of the meta-analysis should be presented in section 5.1 of the SmPC.
Slovenian: Poleg tega je treba v poglavje 5.1 povzetka glavnih značilnosti zdravila vključiti podatke iz metaanalize.
English: 2 von Hertzen H et al. Low dose mifepristone and two regimens of levonorgestrel for emergency contraception: a WHO multicentre randomised trial.
Slovenian: Lancet, 1998; 352: 428-33. 2 von Hertzen H et al. Low dose mifepristone and two regimens of levonorgestrel for emergency contraception: a WHO multicentre randomised trial.
English: 5 Glasier A et al. Ulipristal acetate versus levonorgestrel for emergency contraception: a randomized noninferiority trial and meta-analysis.
Slovenian: Obstet Gynecol 2006;108: 1089-97. 5 Glasier A et al. Ulipristal acetate versus levonorgestrel for emergency contraception: a randomized noninferiority trial and meta-analysis.
English: Grounds for the variation to the terms of the marketing authorisation
Slovenian: Podlaga za spremembo pogojev dovoljenja za promet z zdravilom Ob upoštevanju naslednjega:
English: N total
Slovenian: Priloga IV
English: 4 Creinin MD et al. Progesterone receptor modulator for emergency contraception: a randomized controlled trial.
Slovenian: Contraception 2010; 82: 373-378. 4 Creinin MD et al. Progesterone receptor modulator for emergency contraception: a randomized controlled trial.
English: Lancet, 1998; 352: 428-33.
Slovenian: Lancet, 2002; 360: 1803-10 3 Dada OA et al.
English: In contrast, in the two comparative studies of Creinin and colleagues (2006) and Glasier and colleagues (2010), primarily including Caucasian women, a reduced contraceptive efficacy was observed with increasing body weight or BMI (Table
Slovenian: Nasprotno pa so v dveh primerjalnih študijah, ki so ju opravili Creinin in sodelavci (2006) ter Glasier in sodelavci (2010) in
English: Lancet, 2002; 360: 1803-10 3 Dada OA et al. A randomized, double-blind, noninferiority study to compare two regimens of levonorgestrel for emergency contraception in Nigeria.
Slovenian: A randomized, double-blind, noninferiority study to compare two regimens of levonorgestrel for emergency contraception in Nigeria.
English: The dose for children aged three to 13 years depends on their body weight.
Slovenian: Odmerek za otroke od 3 do 13 let starosti je odvisen od njihove telesne mase.
English: Most of these patients had not taken protease inhibitors in the past.
Slovenian: Večina teh bolnikov v preteklosti ni jemala zaviralcev proteaz.
English: It is available as an oral powder (50 mg per gram) and as tablets (250 mg).
Slovenian: Na voljo je v obliki peroralnega praška (50 mg na gram) in tablet (250 mg).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Viracept on 22 January 1998.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Viracept, veljavno po vsej Evropski uniji, odobrila dne 22. januarja 1998
English: The full EPAR for Viracept 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) za zdravilo Viracept je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Viracept has also been studied in 37 children.
Slovenian: Zdravilo Viracept so raziskovali tudi pri 37 otrocih.
English: When the enzyme is blocked, the virus does not reproduce normally, slowing down the spread of infection.
Slovenian: Ko je encim blokiran, se virus ne more več normalno razmnoževati, kar upočasni širjenje okužbe.
English: EPAR summary for the public nelfinavir
Slovenian: Povzetek EPAR za javnost nelfinavir
English: Viracept should not be used in patients who are taking any of the following medicines:
Slovenian: Zdravilo Viracept se ne sme uporabljati pri bolnikih, ki jemljejo katero koli od naslednjih zdravil:
English: • medicines that are broken down in the same way as Viracept and are harmful at high levels in the blood.
Slovenian: • zdravila, ki se presnavljajo na enak način kot zdravilo Viracept in so pri visokih ravneh v krvi škodljiva.
English: For patients aged over 13 years, the recommended dose of Viracept is 1,250 mg twice a day or 750 mg three times a day, taken with food.
Slovenian: Za bolnike, ki so starejši od 13 let, znaša priporočeni odmerek zdravila Viracept 1 250 mg dvakrat na dan ali 750 mg trikrat na dan s hrano.
English: For more information about treatment with Viracept, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Viracept preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte s svojim zdravnikom ali farmacevtom.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Viracept.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Viracept, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: The study in children showed that the medicine produced similar levels of the active substance in the blood in children and adults, with similar side effects and effectiveness.
Slovenian: Študija pri otrocih je pokazala, da je zdravilo povzročilo podobne ravni zdravilne učinkovine v krvi otrok in odraslih ter podobne neželene učinke in učinkovitost.
English: The Committee and recommended that it be given marketing authorisation.
Slovenian: Odbor je priporočil, da se za cepivo odobri dovoljenje za promet.
English: It blocks an enzyme called protease that is involved in the reproduction of HIV.
Slovenian: Ta zavira encim, imenovan proteaza, ki sodeluje pri razmnoževanju virusa HIV.
English: Viracept does not cure HIV infection or AIDS, but it may delay the damage to the immune system and the development of infections and diseases associated with AIDS.
Slovenian: Zdravilo Viracept ne zdravi okužbe z virusom HIV ali AIDS-a, lahko pa podaljša čas do pojava okvar imunskega sistema ter razvoja okužb in bolezni, ki so povezane z AIDS-om.
English: Viracept, taken in combination with other antiviral medicines, reduces the amount of HIV in the blood and keeps it at a low level.
Slovenian: Zdravilo Viracept v kombinaciji z drugimi protivirusnimi zdravili zniža količino virusa HIV v krvi in jo vzdržuje na nizki ravni.