FrancophonIA/ELRC3.0 huggingface dataset:
English: This is a summary of the European public assessment report (EPAR) for Vimpat.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Vimpat.
English: What are the risks associated with Vimpat?
Slovenian: Kakšna tveganja so povezana z zdravilom Vimpat?
English: Vimpat must not be used in people who have second or third degree AV block (a type of heart rhythm disorder).
Slovenian: Zdravila Vimpat ne smejo uporabljati osebe, ki imajo AV blok druge ali tretje stopnje (vrsto motnje srčnega ritma).
English: It can be used to treat partial-onset seizures with or without secondary generalisation (where the seizure subsequently spreads to other parts of the brain).
Slovenian: Uporablja se lahko za zdravljenje napadov parcialnega izvora s sekundarno generalizacijo ali brez nje (ko se napad posledično razširi na druge dele možganov).
English: If treatment with Vimpat has to be stopped, the dose should be gradually reduced.
Slovenian: Če je treba zdravljenje z zdravilom Vimpat prekiniti, je treba odmerek zmanjševati postopoma.
English: This action may prevent abnormal electrical activity spreading through the brain, reducing the chance of an epileptic fit.
Slovenian: To lahko prepreči širjenje nenormalne električne dejavnosti po možganih, s čimer se zmanjša možnost pojava epileptičnega napada.
English: This compared with 23% of the patients taking placebo.
Slovenian: Ta delež je pri bolnikih, ki so jemali placebo, znašal 23 %.
English: The company also provided data to support dosing of Vimpat in children from 4 years of age and supportive results from studies of the safety of Vimpat in this population.
Slovenian: Družba je zagotovila tudi podatke v podporo odmerjanju zdravila Vimpat pri otrocih, starih štiri leta ali več, in podporne rezultate iz študij o varnosti zdravila Vimpat pri tej populaciji.
English: Two additional studies looked at the appropriate duration of the infusion for Vimpat solution and compared its safety with that of placebo infusions in a total of 199 patients.
Slovenian: V dveh dodatnih študijah so ugotavljali ustrezno trajanje infundiranja raztopine zdravila Vimpat ter primerjali njegovo varnost z infuzijami placeba pri 199 bolnikih.
English: Other information about Vimpat
Slovenian: Druge informacije o zdravilu Vimpat
English: In younger patients weighing less than 50 kg, the dose is based on body weight, and treatment may be started with the syrup.
Slovenian: Pri mlajših bolnikih s telesno maso, manjšo od 50 kg, odmerek temelji na telesni masi, zdravljenje pa se lahko začne s sirupom.
English: If the doctor decides that a faster effect is needed, treatment in some patients with Vimpat may be started with a higher first dose (called a loading dose).
Slovenian: Če zdravnik meni, da je potreben hitrejši učinek, se lahko zdravljenje z zdravilom Vimpat prične z višjim začetnim odmerkom (imenovanim polnilni odmerek).
English: Taking the known side effects into account, the Agency considered Vimpat's benefits to be greater than its risks and recommended that it be given marketing authorisation.
Slovenian: Agencija je ob upoštevanju znanih neželenih učinkov menila, da so koristi zdravila Vimpat večje od z njim povezanih tveganj, in priporočila, da se zanj izda dovoljenje za promet.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Vimpat 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 Vimpat upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
English: The 600-mg dose was as effective as the 400-mg dose, but it had more side effects.
Slovenian: 600-miligramski odmerek je bil enako učinkovit kot 400-miligramski odmerek, vendar je povzročal več neželenih učinkov.
English: Around 78% of Vimpat-treated and 83% of carbamazepine-treated patients did not have a seizure for 12 months.
Slovenian: Približno 78 % bolnikov, ki so jemali zdravilo Vimpat, in 83 % tistih, ki so jemali karbamazepin, ni imelo epileptičnega napada 12 mesecev.
English: For more information about treatment with Vimpat read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Vimpat preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: Vimpat is an epilepsy medicine used to treat partial-onset seizures (epileptic fits starting in one specific part of the brain) in patients with epilepsy aged 4 years and older.
Slovenian: Vimpat je zdravilo proti epilepsiji, ki se uporablja za zdravljenje parcialnih napadov (epileptičnih napadov, ki se začnejo v določenem delu možganov) pri bolnikih z epilepsijo, starejših od 4 let.
English: The most common side effects with Vimpat (seen in more than 1 patient in 10) are dizziness, headache, diplopia (double vision) and nausea (feeling sick).
Slovenian: Najpogostejši neželeni učinki zdravila Vimpat (opaženi pri več kot 1 bolniku od 10) so omotica, glavobol, diplopija (dvojni vid) in navzeja (slabost).
English: The main measure of effectiveness was the proportion of patients who did not have a seizure for at least 6 months after reaching a stable dose.
Slovenian: Glavno merilo učinkovitosti je bil delež bolnikov, ki niso imeli epileptičnega napada vsaj šest mesecev po doseženem ustaljenem odmerku.
English: Why is Vimpat approved?
Slovenian: Zakaj je bilo zdravilo Vimpat odobreno?
English: This was found to be 90% in those taking Vimpat and 91% in those taking carbamazepine.
Slovenian: Ta delež je pri bolnikih, ki so jemali zdravilo Vimpat, znašal 90 %, pri tistih, ki so jemali karbamazepin, pa 91 %.
English: Vimpat was more effective than placebo (a dummy treatment) at reducing seizures in three main studies involving a total of 1,308 patients aged 16 years and above also taking other epilepsy medicines.
Slovenian: Zdravilo Vimpat je bilo učinkovitejše od placeba (zdravila brez zdravilne učinkovine) pri zmanjševanju števila napadov v treh glavnih študijah, v katerih je sodelovalo 1 308 bolnikov, starih 16 ali več let, ki so jemali tudi druga zdravila proti epilepsiji.
English: Vimpat is given on its own or combined with other medicines for epilepsy.
Slovenian: Zdravilo Vimpat se daje samostojno ali v kombinaciji z drugimi zdravili za zdravljenje epilepsije.
English: The usual starting dose in adults and older children (weighing at least 50 kg) is 50 mg twice a day which may be increased weekly to a maximum dose of 300 mg twice a day if used alone, or 200 mg twice a day if given with other epilepsy medicines.
Slovenian: Običajni začetni odmerek pri odraslih in starejših otrocih (s telesno maso najmanj 50 kg) je 50 mg dvakrat na dan, ki se ga lahko tedensko povečuje do največjega odmerka 300 mg dvakrat na dan, če se zdravilo uporablja samostojno, ali 200 mg dvakrat na dan, če se daje z drugimi zdravili za epilepsijo.
English: For practical information about using Vimpat, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Vimpat naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: The European Medicines Agency decided that Vimpat, used alone or added to other epilepsy medicines, had been shown to be effective in the treatment of partial onset seizures.
Slovenian: Evropska agencija za zdravila je zaključila, da je zdravilo Vimpat, ki se uporabi samostojno ali kot dodatek k drugemu zdravilu za epilepsijo, dokazano učinkovito pri zdravljenju parcialnih napadov.
English: A fourth study involving 888 recently diagnosed patients showed that Vimpat, used on its own by mouth at a dose of 200 mg to 600 mg a day, was at least as effective as carbamazepine, another medicine for epilepsy.
Slovenian: Četrta študija, v katero je bilo vključenih 888 nedavno diagnosticiranih bolnikov, je pokazala, da je bilo zdravilo Vimpat, uporabljeno samostojno in vzeto peroralno v odmerku od 200 mg do 600 mg na dan, vsaj tako učinkovito kot karbamazepin, drugo zdravilo proti epilepsiji.
English: Lower doses should be used in patients with severely reduced kidney function or reduced liver function.
Slovenian: Pri bolnikih s hudo okvaro delovanja ledvic je treba uporabljati nižje odmerke.
English: Taking the results of the three main studies together, 34% of the patients taking Vimpat 200 mg a day and 40% of the patients taking Vimpat 400 mg a day with their existing treatment had a reduction in their seizures by at least half.
Slovenian: Ob upoštevanju rezultatov treh glavnih študij skupaj se je pri 34 % bolnikov, ki so poleg obstoječega zdravljenja jemali zdravilo Vimpat v odmerku 200 mg na dan, in 40 % bolnikov, ki so poleg obstoječega zdravljenja jemali zdravilo Vimpat v odmerku 400 mg na dan, število epileptičnih napadov zmanjšalo vsaj za pol.
English: For the full list of all side effects and restrictions with Vimpat, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Vimpat glejte navodilo za uporabo.
English: How is Vimpat used?
Slovenian: Kako se zdravilo Vimpat uporablja?
English: The main measure of effectiveness was the number of patients whose number of seizures was at least halved after 12 weeks of treatment with a stable dose.
Slovenian: Glavno merilo učinkovitosti je bilo število bolnikov, pri katerih se je število epileptičnih napadov po 12 tednih zdravljenja z ustaljenim odmerkom vsaj prepolovilo.
English: An additional study in 118 patients was carried out to test that starting treatment with doses of 200 mg Vimpat by infusion, followed by regular doses taken by mouth, can be applied safely and that adequate levels in the body are achieved.
Slovenian: Dodatna študija je bila izvedena pri 118 bolnikih z namenom proučevanja varnosti začetnega zdravljenja z infundiranjem 200-miligramskega odmerka zdravila Vimpat, ki mu sledijo vzdrževalni odmerki, zaužiti peroralno, in ugotavljanja, ali to privede do ustreznih ravni zdravilne učinkovine v telesu.
English: Vimpat can only be obtained with a prescription and is available as tablets (50 mg; 100 mg; 150 mg; 200 mg), as a syrup (10 mg/ml) and as a solution for infusion (drip) into a vein.
Slovenian: Na voljo je v obliki tablet (50 mg, 100 mg, 150 mg, 200 mg), kot sirup (10 mg/ml) in raztopina za infundiranje (kapalna infuzija) v veno.
English: Vimpat lacosamide
Slovenian: Vimpat lakozamid
English: For more details see the package leaflet.
Slovenian: Za več informacij glejte navodilo za uporabo.
English: How does Vimpat work?
Slovenian: Kako zdravilo Vimpat deluje?
English: Side effects affecting the nervous system such as dizziness may be higher after a loading dose and dizziness was the most common reason for stopping treatment.
Slovenian: Neželeni učinki, ki prizadenejo živčni sistem, kot je na primer omotica, utegnejo biti večji po uporabi polnilnega odmerka.
English: The active substance in Vimpat, lacosamide, is an epilepsy medicine.
Slovenian: Zdravilna učinkovina v zdravilu Vimpat, lakozamid, je zdravilo proti epilepsiji.
English: It contains the active substance lacosamide.
Slovenian: Vsebuje zdravilno učinkovino lakozamid.
English: Patients were given Vimpat by mouth at a dose of 200 mg, 400 mg or 600 mg a day, or placebo in addition to their existing treatment of up to three other epilepsy medicines.
Slovenian: Bolniki so poleg obstoječega zdravljenja z največ tremi drugimi zdravili proti epilepsiji začeli peroralno jemati tudi zdravilo Vimpat v odmerku 200 mg, 400 mg ali 600 mg na dan ali placebo.
English: • Risk Management Plan (RMP)
Slovenian: - Načrt za obvladovanje tveganja (RMP)
English: Alternative treatments should be considered.
Slovenian: Razmisliti je treba o alternativnem zdravljenju.
English: They are available in packs of:
Slovenian: Na voljo so v pakiranjih po:
English: Your doctor will check this.
Slovenian: To bo preveril vaš zdravnik.
English: These medicinal products should be used with caution.
Slovenian: Ta zdravila je treba uporabljati previdno.
English: Special considerations for patients who smoke
Slovenian: Posebno opozorilo za bolnike, ki kadijo
English: Riociguat has a dual mode of action.
Slovenian: Riociguat ima dvojni mehanizem delovanja.
English: Your doctor may decide to monitor your blood pressure.
Slovenian: Zdravnik se lahko odloči, da bo spremljal vaš krvni tlak.
English: No such effects were observed in adult rats.
Slovenian: Teh učinkov pri odraslih podganah niso opazili.
English: The relevance of this finding for humans is unknown.
Slovenian: Pomen teh izsledkov za ljudi ni znan.
English: In case of pronounced hypotension, active cardiovascular support may be required.
Slovenian: V primeru močno izražene hipotenzije je lahko potrebna aktivna kardiovaskularna podpora.
English: • inoperable CTEPH,
Slovenian: • neoperabilno CTEPH,
English: The absolute bioavailability of riociguat is high (94%).
Slovenian: Absolutna biološka uporabnost riociguata je velika (94 %).
English: The use of Adempas in children and adolescents (under 18 years of age) should be avoided because efficacy and safety have not been established for this age group.
Slovenian: Uporabi zdravila Adempas pri otrocih in mladostnikih (starih manj kot 18 let) se je treba izogibati, ker učinkovitost in varnost nista bili dokazani za to starostno skupino.
English: Until more is known about the implications of these findings the use of riociguat in children and in growing adolescents should be avoided.
Slovenian: Dokler ni znanega več o pomenu teh izsledkov, se je treba uporabi riociguata pri otrocih in odraščajočih mladostnikih izogibati.
English: This also includes recreational drugs called poppers.
Slovenian: To vključuje tudi rekreacijske droge, t. i. »poppers«.
English: Terminal half-life increased from 7.3 to 9.2 hours and total body clearance decreased from 6.1 to 2.4 L/h.
Slovenian: Končni razpolovni čas se je povečal s 7,3 na 9,2 ure, celokupni očistek iz telesa pa se je zmanjšal s 6,1 na 2,4 l/h.
English: Monthly pregnancy tests are recommended.
Slovenian: Priporoča se mesečna uporaba testov za ugotavljanje nosečnosti.
English: Tablets can generally be taken with or without food.
Slovenian: Tablete se lahko jemljejo s hrano ali brez nje.
English: Frequencies are defined as: 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) and not known (cannot be estimated from the available data).
Slovenian: Pogostnosti so opredeljene kot: 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) in neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: Elimination half-life is about 7 hours in healthy subjects and about 12 hours in patients.
Slovenian: Razpolovni čas izločanja je pri zdravih osebah približno 7 ur, pri bolnikih pa 12 ur.
English: Improved Stable Deteriorated p-value
Slovenian: izboljšanje stabilno poslabšanje vrednost p
English: Doses above 1 mg riociguat were not investigated in this study.
Slovenian: Odmerkov, večjih od 1 mg riociguata, v tej študiji niso preučevali.
English: Six patients (10%) experienced at least one clinical worsening event, including 2 deaths unrelated to study drug.
Slovenian: Šest bolnikov (10 %) je imelo vsaj eno klinično poslabšanje, vključno z dvema smrtnima primeroma, ki nista bila povezana z zdravilom v preskušanju.
English: Your doctor will check if Adempas is suitable for you.
Slovenian: Vaš zdravnik bo preveril, če je zdravilo Adempas primerno za vas.
English: The safety and efficacy of riociguat in children and adolescents below 18 years have not been established.
Slovenian: Varnost in učinkovitost riociguata pri otrocih in mladostnikih, starih manj kot 18 let, nista bili dokazani.
English: Date of latest renewal: 18 January 2019
Slovenian: Datum prve odobritve: 27. marec 2014 Datum zadnjega podaljšanja: 18. januar 2019
English: If you smoke, it is recommended that you stop, as smoking may reduce the effectiveness of these tablets.
Slovenian: Če kadite, je priporočljivo prenehati s kajenjem, saj lahko kajenje zmanjša učinkovitost teh tablet.
English: The most serious side effects are:
Slovenian: Najbolj resni neželeni učinki so:
English: If your blood pressure drops (which can make you feel dizzy) then you may need immediate medical attention.
Slovenian: Če se vam krvni tlak naglo zniža (zaradi česar ste lahko omotični), morda potrebujete takojšnjo zdravniško pomoč.
English: Plasma concentrations of riociguat in smokers are reduced compared to non-smokers.
Slovenian: Koncentracije riociguata v plazmi so pri kadilcih manjše kot pri nekadilcih.
English: Adempas can be taken alone or together with certain other medicines used to treat PAH.
Slovenian: Zdravilo Adempas se lahko jemlje samo ali skupaj z določenimi drugimi zdravili, ki se uporabljajo za zdravljenje PAH.
English: In case of overdose, standard supportive measures should be adopted as required.
Slovenian: V primeru prevelikega odmerjanja je treba uvesti ustrezne standardne podporne ukrepe.
English: 65 years or older
Slovenian: Bolniki, stari 65 let ali več
English: Patients with mild and moderate renal impairment were included in the pivotal studies.
Slovenian: Bolniki z blago in zmerno ledvično okvaro so bili vključeni v ključne študije.
English: Do not stop taking this medicine without talking to your doctor first, because this medicine prevents the progression of the disease.
Slovenian: Ne prenehajte jemati tega zdravila brez predhodnega posveta z zdravnikom, saj to zdravilo preprečuje napredovanje bolezni.
English: During the first weeks of treatment your doctor will need to measure your blood pressure at regular intervals.
Slovenian: V prvih tednih zdravljenja vam bo zdravnik moral meriti krvni tlak v rednih intervalih.
English: If you are older than 65 years, you have an increased risk of developing low blood pressure.
Slovenian: Če ste starejši od 65 let, imate povečano tveganje za nizek krvni tlak.
English: The volume of distribution is moderate with volume of distribution at steady state being approximately 30 L.
Slovenian: Volumen porazdelitve je zmeren; volumen porazdelitve v stanju dinamičnega ravnovesja je približno 30 l.
English: Based on this study and as riociguat is not an inducer of any of the relevant metabolic enzymes, also no pharmacokinetic interaction is expected with other hormonal contraceptives.
Slovenian: Glede na to študijo in ker riociguat ni induktor katerega koli od pomembnih encimov presnove, tudi farmakokinetičnih interakcij z drugimi hormonskimi kontraceptivi ni pričakovati.
English: If you miss a dose, continue with the next dose as planned.
Slovenian: Če ste pozabili vzeti odmerek, nadaljujte z naslednjim odmerkom, kot je načrtovano.
English: Your doctor will regularly monitor you.
Slovenian: Zdravnik bo redno spremljal zdravljenje.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Adempas in one or more subsets of the paediatric population in the treatment of pulmonary hypertension.
Slovenian: Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z zdravilom Adempas za eno ali več podskupin pediatrične populacije pri zdravljenju pljučne hipertenzije.
English: Effects of other substances on riociguat
Slovenian: Vpliv drugih učinkovin na riociguat
English: Because the heart must work harder than normal, people with pulmonary hypertension feel tired, dizzy and short of breath.
Slovenian: Ker mora srce delati močneje kot običajno, se bolniki s pljučno hipertenzijo počutijo utrujene, omotične in zasople.
English: In case treatment has to be interrupted for 3 days or more, treatment should be restarted with 1 mg three times daily for 2 weeks, and continued with the dose titration regimen as described above.
Slovenian: Če je treba zdravljenje prekiniti za 3 dni ali več, je treba zdravljenje ponovno začeti z odmerkom 1 mg trikrat na dan 2 tedna, nato pa zdravljenje nadaljevati s titriranjem odmerka, kot je opisano zgoraj.
English: If your treatment has to be stopped for 3 days or more, please tell your doctor before restarting your treatment.
Slovenian: Če morate zdravljenje prekiniti za 3 dni ali več, obvestite zdravnika, preden začnete ponovno jemati zdravilo.
English: Riociguat pharmacokinetics are linear from 0.5 to 2.5 mg. Inter-individual variability (CV) of riociguat exposure (AUC) across all doses is approximately 60%.
Slovenian: Farmakokinetika riociguata je linearna od 0,5 do 2,5 mg. Interindividualna variabilnost (CV) izpostavljenosti riociguatu (AUC) je za vse odmerke približno 60 %.
English: With increased doses, over additive effects on systemic blood pressure were observed in some cases.
Slovenian: Pri povečevanju odmerkov so v nekaterih primerih opazili več kot aditivne učinke na sistemski krvni tlak.
English: Data from animals indicate that riociguat is excreted into milk.
Slovenian: Podatki na živalih kažejo, da se riociguat izloča v mleko.
English: Patients with ALT > 3 x ULN and bilirubin > 2 x ULN were not studied (see section 4.4).
Slovenian: Bolnikov z ALT > 3 x ULN in bilirubinom > 2 x ULN niso preučevali (glejte poglavje 4.4).
English: Riociguat is rapidly absorbed with maximum concentrations (Cmax) appearing 1-1.5 hours after tablet intake.
Slovenian: Riociguat se hitro absorbira in doseže največje koncentracije (Cmax) 1 - 1,5 ure po zaužitju tablete.
English: In juvenile rats, the changes consisted of thickening of trabecular bone and of hyperostosis and remodeling of metaphyseal and diaphyseal bone, whereas in adolescent rats an overall increase of bone mass was observed.
Slovenian: Pri mladih podganah so spremembe predstavljali zadebelitev trabekularne kosti in hiperostoza ter preoblikovanje metafiz in diafiz, medtem ko so pri adolescentnih podganah opazili celokupno povečanje kostne mase.
English: If any of these applies to you, talk to your doctor first and do not take Adempas.
Slovenian: Če kar koli od navedenega velja za vas, se najprej posvetujte z zdravnikom in ne jemljite zdravila Adempas.
English: • persistent or recurrent CTEPH after surgical treatment, to improve exercise capacity (see section 5.1).
Slovenian: • perzistentno ali ponovno CTEPH po kirurškem zdravljenju, za izboljšanje telesne zmogljivosti (glejte poglavje 5.1).
English: Do not use this medicine after the expiry date which is stated on the blister and carton after “EXP”.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na pretisnem omotu in škatli poleg oznake "EXP".
English: Your dose may need to be adjusted.
Slovenian: Vaš odmerek bo morda treba prilagoditi.
English: Concomitant use with CYP3A4 inducers
Slovenian: Sočasna uporaba z induktorji CYP3A4
English: Individual dose titration at treatment initiation allows adjustment of the dose to the patient´s needs.
Slovenian: Titriranje odmerka na začetku zdravljenja omogoča prilagoditev le-tega bolnikovim potrebam.
English: Do not take Adempas during pregnancy.
Slovenian: Zdravila Adempas ne smete jemati med nosečnostjo.
English: Warfarin/phenprocoumon
Slovenian: Varfarin/fenprokumon
English: If this happens, contact your doctor immediately as you may need urgent medical treatment.
Slovenian: V tem primeru takoj obvestite zdravnika, saj morda potrebujete takojšnjo zdravniško pomoč.
English: It works by widening the pulmonary arteries (the blood vessels that connect the heart to the lungs), making it easier for the heart to pump blood through the lungs.
Slovenian: Deluje tako, da razširi pljučne arterije (krvne žile, ki povezujejo srce s pljuči) in zato srce lažje črpa kri skozi pljuča.
English: Tél : + 33 (0) 1 80 46 40 40
Slovenian: MSD FRANCE Tél : + 33 (0) 1 80 46 40 40
English: If there is a chance you could become pregnant, use reliable forms of contraception while you are taking these tablets.
Slovenian: Če obstaja možnost da zanosite, morate med jemanjem teh tablet uporabljati zanesljive kontracepcijske metode.