FrancophonIA/ELRC3.0 huggingface dataset:
English: NAME OF THE MEDICINAL PRODUCT Pregabalin Mylan Pharma 200 mg hard capsules pregabalin
Slovenian: Pregabalin Mylan Pharma 200 mg trde kapsule pregabalin
English: The capsule is axially printed with MYLAN over PB75 in black ink on cap and body.
Slovenian: Kapsula ima na telesu in pokrovčku s črnim črnilom vzdolžno odtisnjeno oznako MYLAN preko PB75.
English: • Weight gain
Slovenian: • oteženo požiranje
English: • Dilated pupils, cross eyes
Slovenian: • razširjene zenice, škiljenje
English: The capsule is axially printed with MYLAN over PB100 in black ink on cap and body.
Slovenian: Kapsula ima na telesu in pokrovčku s črnim črnilom vzdolžno odtisnjeno oznako MYLAN preko PB100.
English: No. 4, light peach opaque cap and white opaque body, hard-shell gelatin capsule filled with white to off-white powder.
Slovenian: Trda želatinasta kapsula, velikosti št. 4, z belim neprozornim telesom kapsule in neprozornim pokrovčkom kapsule svetlo breskove barve.
English: Pregabalin has been studied in 1 controlled clinical trial of 56 week duration with BID dosing.
Slovenian: Pregabalin so preučevali v 1 kontroliranem kliničnem preskušanju v trajanju 56 tednov z odmerjanjem 2-krat na dan. Kar zadeva 6-mesečno zaustavitev pojavljanja epileptičnih napadov pregabalin ni bil enako učinkovit kot lamotrigin.
English: NAME OF THE MEDICINAL PRODUCT Pregabalin Mylan Pharma 50 mg hard capsules pregabalin
Slovenian: Pregabalin Mylan Pharma 50 mg trde kapsule pregabalin
English: ANNEX II
Slovenian: DRUGI PODATKI
English: Muscle cramp, arthralgia, back pain, pain in limb, cervical spasm
Slovenian: Redki krči mišic, artralgija, bolečine v hrbtu, bolečine v udih, spazem v vratu otekanje sklepov, mialgija, trzanje mišic, bolečine v vratu, togost mišic rabdomioliza
English: PVC/PVDC-Al perforated unit dose blister pack containing 14 x 1, 56 x 1 and 100 x 1 hard capsules.
Slovenian: PVC/PVDC/aluminijev pretisni omot s po 14, 56 in 100 trdimi kapsulami.
English: Packaging Content Package size Withdrawal Period
Slovenian: Način uporabe Pakiranje Vsebina Velikost pakiranja
English: 120 pre-filled syringes (in a plastic bucket)
Slovenian: Karenca injektorjev (v plastičnem vedru)
English: Target species Route of administration
Slovenian: Ciljna živalska vrsta
English: MA Numbers Invented name Strength Pharmaceutical Form
Slovenian: Jakost Farmacevtska oblika
English: This summary was last updated in 02-2009.
Slovenian: Povzetek je bil nazadnje posodobljen 02-2009.
English: At the start of the study, patients had around 13 seizures per month.
Slovenian: Na začetku študije so imeli bolniki okoli 13 napadov na mesec.
English: The main measure of effectiveness for the three studies was the reduction in the number of seizures over 12 weeks.
Slovenian: Glavno merilo učinkovitosti v vseh treh študijah je bilo zmanjšanje števila napadov v 12 tednih.
English: Exalief is also not recommended in children below 18 years of age.
Slovenian: Zdravilo Exalief ni priporočeno za otroke, mlajše od 18 let.
English: Other information about Exalief:
Slovenian: Druge informacije o zdravilu Exalief:
English: The European Commission granted a marketing authorisation valid throughout the European Union for Exalief to Bial - Portela & Ca, SA on 21 April 2009.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Exalief, veljavno po vsej Evropski uniji, odobrila družbi Bial - Portela & Ca, SA dne 21. aprila 2009.
English: Secondary generalisation occurs when the overactivity later reaches the whole brain.
Slovenian: Sekundarna generalizacija se pojavi, ko prekomerna aktivnost pozneje zajame celotne možgane.
English: All of the patients also received other anti-epileptic medicines.
Slovenian: Vsi bolniki so prejemali tudi druga zdravila proti epilepsiji.
English: Epilepsy is caused by excessive electrical activity in the brain.
Slovenian: Epilepsijo povzroča prekomerna električna aktivnost v možganih.
English: This is a type of epilepsy where too much electrical activity in one side of the brain causes symptoms such as sudden, jerky movements of one part of the body, distorted hearing, sense of smell, or vision, numbness or a sudden sense of fear.
Slovenian: To je vrsta epilepsije, pri kateri pride do prevelike električne aktivnosti na samo eni strani možganov, ki povzroči simptome, kot so nenadni sunkoviti gibi enega dela telesa, motnje sluha, voha ali vida, odrevenelost ali nenaden občutek strahu.
English: It is available as white tablets (round: 400 mg; oblong: 600 mg and 800 mg).
Slovenian: Na voljo je v obliki belih tablet (okroglih: 400 mg; podolgovatih: 600 mg in 800 mg).
English: The effects of Exalief were first tested in experimental models before being studied in humans.
Slovenian: Učinki zdravila Exalief so bili najprej preizkušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
English: The Committee recommended that Exalief be given marketing authorisation.
Slovenian: Odbor je priporočil, da se za zdravilo Exalief odobri dovoljenje za promet.
English: The dose may be increased to 1,200 mg once a day depending on how the patient responds to treatment.
Slovenian: Odmerek lahko povečamo tudi na 1 200 mg enkrat dnevno, odvisno od bolnikovega odziva na zdravljenje.
English: The medicine is not recommended in patients with severe problems with their kidneys or liver.
Slovenian: Zdravilo ni priporočeno pri bolnikih s hudimi težavami z ledvicami ali jetri.
English: It must not be used in people with second or third degree atrioventricular block (a problem with electrical transmission in the heart).
Slovenian: Ne sme se uporabljati pri osebah z atrioventrikularno blokado druge ali tretje stopnje (težavami s prenosom električnih impulzov v srcu).
English: This reduces the activity of the nerve cells in the brain, reducing the intensity and the number of seizures.
Slovenian: Posledica tega je zmanjšanje aktivnosti živčnih celic v možganih in zmanjšanje silovitosti in števila napadov.
English: Three main studies were performed, involving a total of 1,050 adults with partial-onset seizures that were not controlled by other medicines.
Slovenian: Izvedene so bile tri glavne študije, ki so vključevale 1 050 odraslih s parcialnimi napadi, ki niso bili zdravljeni z drugimi zdravili.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) EXALIEF EPAR summary for the public
Slovenian: EVROPSKO JAVNO POROČILO O OCENI ZDRAVILA (EPAR) EXALIEF Povzetek EPAR za javnost
English: Exalief should be used with caution in patients aged above 65 years because there is not enough information on the medicine's safety in these patients.
Slovenian: Bolniki, starejši od 65 let, morajo zdravilo Exalief uporabljati previdno, ker ni na voljo dovolj podatkov o varnosti zdravila v tej skupini bolnikov.
English: Exalief can be taken with or without food.
Slovenian: Zdravilo Exalief se lahko jemlje s hrano ali brez nje.
English: The most common side effects with Exalief (seen in more than 1 patient in 10) are dizziness and somnolence (sleepiness).
Slovenian: Najpogostejša neželena učinka zdravila Exalief (opažena pri več kot 1 izmed 10 bolnikov) sta omotica in zaspanost.
English: What benefit has Exalief shown during the studies?
Slovenian: Kakšne koristi je zdravilo Exalief izkazalo med študijami?
English: What is the risk associated with Exalief?
Slovenian: Kakšna tveganja so povezana z zdravilom Exalief?
English: For electrical impulses to travel along nerves there needs to be a rapid movement of sodium into the nerve cells.
Slovenian: Da lahko električni impulzi potujejo po živcih, mora biti pretok natrija v živčne celice hiter.
English: Over the 12 weeks of treatment, this fell to 9.8 and 9 seizures per month in patients taking Exalief 800 mg and Exalief 1200 mg respectively, compared with 11.7 per month in those taking placebo.
Slovenian: V 12 tednih zdravljenja se je število napadov zmanjšalo na 9,8 in 9 napadov mesečno pri bolnikih, ki so jemali zdravili Exalief 800 mg in Exalief 1 200 mg, v primerjavi z 11,7 napada mesečno pri bolnikih, ki so jemali placebo.
English: Exalief should not be used in people who may be hypersensitive (allergic) to eslicarbazepine acetate, any of the other ingredients or other carboxamide derivatives (medicines with a similar structure to eslicarbazepine acetate, such as carbamazepine or oxcarbazepine).
Slovenian: Zdravila Exalief ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) eslikabazepin acetat, katero koli drugo sestavino zdravila ali druge derivate karboksamida (zdravila s podobno zgradbo kot eslikarbazepin acetat, kot sta karbamazepin ali okskarbazepin).
English: Exalief is a medicine that contains the active substance eslicarbazepine acetate.
Slovenian: Exalief je zdravilo, ki vsebuje zdravilno učinkovino eslikarbazepin acetat.
English: Exalief must only be used as an ‘add-on' to other anti-epileptic medicines.
Slovenian: Zdravilo Exalief se lahko uporablja samo kot dodatek k drugim zdravilom proti epilepsiji.
English: Exalief is used to treat adults with partial-onset seizures (epileptic fits) with or without secondary generalisation.
Slovenian: Zdravilo Exalief se uporablja za zdravljenje odraslih s parcialnimi napadi (epileptičnimi napadi) s sekundarno generalizacijo ali brez nje.
English: Exalief treatment starts at a dose of 400 mg once a day, before increasing it to the standard dose of 800 mg once a day after one or two weeks.
Slovenian: Zdravljenje z zdravilom Exalief se začne s 400-miligramskim odmerkom enkrat dnevno, ki se nato po enem ali dveh tednih poveča na standardni odmerek 800 mg enkrat dnevno.
English: The Committee for Medicinal Products for Human Use (CHMP) decided that Exalief's benefits are greater than its risks for the treatment of partial-onset seizures with or without secondary generalisation in adults who are also taking other anti-epilepsy medicines.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Exalief pri zdravljenju parcialnih napadov s sekundarno generalizacijo ali brez nje pri odraslih, ki jemljejo tudi druga zdravila proti epilepsiji, večje od z njim povezanih tveganj.
English: Why has Exalief been approved?
Slovenian: Zakaj je bilo zdravilo Exalief odobreno?
English: The active substance in Exalief, eslicarbazepine acetate, is converted into the anti-epileptic medicine eslicarbazepine in the body.
Slovenian: Zdravilna učinkovina v zdravilu Exalief, eslikarbazepin acetat, se v telesu pretvori v protiepileptično učinkovino eslikarbazepin.
English: For the full list of all side effects reported with Exalief, see the Package Leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Exalief, glejte navodilo za uporabo.
English: Looking at the results of the three studies taken together, Exalief 800 mg and 1200 mg were more effective than placebo at reducing the number of seizures, when used as add-ons to other anti-epileptic medicines.
Slovenian: Upoštevajoč rezultate vseh treh študij, sta bili zdravili Exalief 800 mg in 1 200 mg, uporabljeni kot dodatek k drugim zdravilom k epilepsiji, učinkovitejši od placeba pri zmanjševanju števila napadov.
English: All three studies compared Exalief given at different doses (400 mg, 800 mg or 1200 mg once a day) with placebo (a dummy treatment).
Slovenian: V vseh treh študijah so zdravilo Exalief v različnih odmerkih (400 mg, 800 mg ali 1 200 mg enkrat dnevno) primerjali s placebom (zdravilom brez zdravilne učinkovine).
English: Eslicarbazepine is thought to work by blocking ‘voltage-gated sodium channels', which stops sodium entering the nerve cells.
Slovenian: Eslikarbazepin naj bi zaprl napetostne natrijeve kanalčke, kar prepreči vstop natrija v živčne celice.
English: Exalief should also be used with caution in patients with kidney problems and the dose should be adjusted according to how the kidneys are functioning.
Slovenian: Previdnost pri uporabi zdravila Exalief je potrebna tudi pri bolnikih, ki imajo težave z ledvicami, pri katerih je treba odmerek prilagoditi delovanju ledvic.
English: Almost a half of the patients treated with Exalief experience side effects.
Slovenian: Do neželenih učinkov pride pri skoraj polovici bolnikov, ki jemljejo zdravilo Exalief.
English: How has Exalief been studied?
Slovenian: Kako je bilo zdravilo Exalief raziskano?
English: The full EPAR for Exalief can be found here.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Exalief je na voljo tukaj.
English: What is Exalief used for?
Slovenian: Za kaj se zdravilo Exalief uporablja?
English: How is Exalief used?
Slovenian: Kako se zdravilo Exalief uporablja?
English: How does Exalief work?
Slovenian: Kako zdravilo Exalief deluje?
English: What is Exalief?
Slovenian: Kaj je zdravilo Exalief?
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 25 February 2009
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum prve odobritve: 25. februar 2009
English: Take your dose at around the same time every day.
Slovenian: Odmerek vzemite ob približno istem času vsak dan.
English: The educational material should include:
Slovenian: Izobraževalno gradivo mora vključevati:
English: TTP is a serious condition and requires prompt treatment.
Slovenian: TTP je resno stanje in zahteva takojšnje zdravljenje.
English: This concern applies especially to patients:
Slovenian: Ta skrb velja zlasti za naslednje bolnike:
English: Date of latest renewal: 13 November 2013
Slovenian: Datum zadnjega podaljšanja: 13. november 2013.
English: b Other standard therapies were used as appropriate.
Slovenian: b Ostala standardna zdravljenja so bila ustrezno uporabljena.
English: If this has happened to you, tell your doctor immediately.
Slovenian: Če se vam to zgodi, nemudoma povejte svojemu zdravniku.
English: Frequencies are defined as follows:
Slovenian: Pogostnosti so opredeljene kot:
English: Patients may be counted in more than one row.
Slovenian: Bolniki so lahko našteti v več kot eni vrsti.
English: CV death
Slovenian: CV smrt
English: The study failed to meet any of the primary or secondary endpoints.
Slovenian: Študija ni izpolnila nobenega od primarnih in sekundarnih ciljev študije.
English: • Risk Management Plan (RMP)
Slovenian: Načrt za obvladovanje tveganja (RMP)
English: • Sudden difficulty in walking or loss of balance or co-ordination.
Slovenian: • nenadne težave pri hoji ali izguba ravnotežja ali koordinacije,
English: Therefore, prasugrel should be used with caution in these patients.
Slovenian: Zato moramo pri teh bolnikih prasugrel uporabiti s previdnostjo.
English: The benefit of prasugrel was apparent within the first 3 days and it persisted to the end of study.
Slovenian: Korist prasugrela je bila očitna v prvih 3 dnevih in je vztrajala do konca študije.
English: • If you have an increased risk of bleeding such as: - age of 75 years or older.
Slovenian: • Če imate povečano tveganje za krvavitev, kot je: - starost 75 let ali več.
English: Contact your doctor or hospital straight away, as you may be at risk of excessive bleeding.
Slovenian: Nemudoma se obrnite na svojega zdravnika ali bolnišnico, saj imate morda tveganje za prekomerno krvavitev.
English: Very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1000 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: 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: Therefore, both medicinal products can be administered concomitantly.
Slovenian: Zato lahko sočasno dajemo obe zdravili.
English: No significant difference was seen in the STEMI population.
Slovenian: populacijah niso opazili značilne razlike.
English: Table 3: Patients with Outcome Events in TRITON Primary Analysis
Slovenian: Preglednica 3: Bolniki z izidi v primarni analizi TRITON
English: • Sudden confusion, difficulty speaking or understanding others.
Slovenian: • nenadna zmedenost, težave z govorom ali razumevanjem drugih,
English: These patients may have an increased bleeding risk.
Slovenian: Ti bolniki imajo lahko povečano tveganje za krvavitev.
English: The results of the discussion, and where appropriate the material, should be agreed with the national competent authority and be available prior to launch in each member state.
Slovenian: Rezultati dogovora ter gradivo (kjer je ustrezno) morajo biti dogovorjeni s pristojnim nacionalnim organom ter v vsaki državi članici biti na voljo pred prihodom zdravila na trg.
English: Not Known
Slovenian: Ni znano
English: This leaflet was last revised in {MM/YYYY}.
Slovenian: Navodilo je bilo nazadnje revidirano dne {MM/LLLL}.
English: Tell your doctor if you are taking morphine or other opioids (used to treat severe pain).
Slovenian: Obvestite zdravnika, če jemljete morfin ali druge opioide (ki se uporabljajo za zdravljenje hude bolečine).
English: Active pathological bleeding.
Slovenian: Aktivna patološka krvavitev.
English: • Sudden dizziness or sudden severe headache with no known cause.
Slovenian: • nenadna omotica ali nenaden hud glavobol brez znanega vzroka.
English: The patient population was 92% Caucasian, 26% female, and 39% ≥ 65 years of age.
Slovenian: Populacija bolnikov je bila 92 % belcev, 26 % žensk in 39 % ≥ 65 let starosti.
English: Mechanism of action / Pharmacodynamic effects
Slovenian: Mehanizem delovanja/Farmakodinamični učinki
English: Use of any thienopyridine within 5 days before enrolment was an exclusion criterion.
Slovenian: Uporaba kateregakoli tienopiridina v 5 dneh pred vključitvijo je bila izključitveni kriterij.
English: Acute Coronary Syndrome (ACS)
Slovenian: Akutni koronarni sindrom (ACS)
English: All ACS
Slovenian: Vsi ACS
English: The active metabolite has an elimination half-life of about 7.4 hours (range 2 to 15 hours).
Slovenian: Aktivni presnovek ima razpolovni čas izločanja približno 7,4 ure (razpon 2 do 15 ur).
English: For further information please refer to section 5.1.
Slovenian: Za nadaljnje informacije glejte poglavje 5.1.
English: This interaction may be related to reduced gastrointestinal motility and apply to other opioids.
Slovenian: To medsebojno delovanje je morda povezano z zmanjšano motiliteto prebavil in velja tudi za druge opioide.
English: 81379 Munich
Slovenian: 81379 München
English: The benefit was primarily due to a significant decrease in non-fatal MI (see Table 3).
Slovenian: Korist je bila primarno posledica signifikantnega znižanja ne-smrtnega MI (glejte Preglednico 3).
English: The format and means of dissemination, of this material should be discussed with the appropriate learned societies.
Slovenian: Oblika in način razdeljevanja tega gradiva morata biti dogovorjena z ustreznimi izobraževanimi ustanovami.
English: These may be signs of a severe allergic reaction (see section 2 ‘What you need to know before you take Efient').
Slovenian: To so lahko znaki hude alergijske reakcije (glejte poglavje 2 »Kaj morate vedeti, preden boste vzeli zdravilo Efient«)
English: It is important that you tell your doctor, dentist and pharmacist, that you are taking Efient.
Slovenian: Pomembno je, da poveste svojemu zdravniku, zobozdravniku in farmacevtu, da jemljete zdravilo Efient.
English: All ACS population:
Slovenian: Celotna ACS populacija:
English: 85276 Pfaffenhofen Germany
Slovenian: 85276 Pfaffenhofen
English: • ≥ 75 years of age (see below).
Slovenian: • ≥ 75 let starosti (glejte spodaj).
English: Platelets are very small cell particles that circulate in the blood.
Slovenian: Trombociti (krvne ploščice) so zelo majhni delci celice, ki krožijo v krvi.
English: - If you have severe liver disease.
Slovenian: - Če imate hudo bolezen jeter.
English: Children and adolescents Efient should not be used in children and adolescents below 18 years of age.
Slovenian: Otroci in mladostniki Zdravilo Efient se ne sme uporabljati pri otrocih in mladostnikih, mlajših od 18 let.
English: For all patients, the loading dose could be administered anytime between randomisation and 1 hour after the patient left the catheterisation lab.
Slovenian: Za vse bolnike je bil polnilni odmerek lahko dan kadarkoli med randomizacijo in 1 uro po tem, ko je bolnik zapustil kateterizacijski laboratorij.
English: Therefore, platelets are essential to help stop bleeding.
Slovenian: Zato so trombociti nujni za pomoč pri zaustavitvi krvavitve.
English: In the phase 3 clinical trial, 437 patients underwent CABG during the course of the study.
Slovenian: V kliničnem preskušanju faze 3, je 437 bolnikov prestalo CABG v času trajanja študije.
English: You should use Efient only after discussing with your doctor the potential benefits and any potential risks to your unborn child.
Slovenian: Zdravilo Efient lahko jemljete samo po posvetu z vašim zdravnikom, glede možnih koristi in kakršnihkoli možnih tveganjih za vašega nerojenega otroka.
English: Pharmacokinetics in special Populations
Slovenian: Farmakokinetika pri posebnih populacijah
English: Non-steroidal anti-inflammatory drugs (NSAIDs):
Slovenian: Nesteroidna protivnetna zdravila (NSAIDs):
English: Hypersensitivity including angioedema
Slovenian: Preobčutljivost, vključno z angioedemom
English: 81366 Munich
Slovenian: 81366 München
English: For oral use.
Slovenian: Za peroralno uporabo.
English: Patients should be told that it might take longer than usual to stop bleeding when they take prasugrel (in combination with ASA), and that they should report any unusual bleeding (site or duration) to their physician.
Slovenian: Bolnikom je treba povedati, da bo morda trajalo dlje kot običajno, da se ustavi krvavitev, kadar jemljejo prasugrel (v kombinaciji z ASK) ter da morajo svojemu zdravniku sporočiti vsako neobičajno krvavitev (mesto ali trajanje).
English: Exposure in subjects of African and Hispanic descent is comparable to that of Caucasians.
Slovenian: Izpostavljenost pri osebah afriškega ali španskega izvora je primerljiva s tisto pri belcih.
English: Hazard Ratio (HR) (95% CI)
Slovenian: Razmerje tveganja (RT) (95% IZ)
English: Avda de la Industria 30 E-28108 Alcobendas (Madrid) Spain
Slovenian: Avda de la Industria 30 E-28108 Alcobendas (Madrid) Španija
English: The use of prasugrel during breastfeeding is not recommended.
Slovenian: Uporabe prasugrela v obdobju dojenja ne priporočamo.
English: - If you have a medical condition that is currently causing bleeding, such as bleeding from your stomach or intestines.
Slovenian: - Če imate zdravstveno stanje, ki trenutno povzroča krvavitev, kot je krvavitev iz želodca ali črevesja.
English: • Sudden numbness or weakness of the arm, leg or face, especially if only on one side of the body.
Slovenian: • nenadna odrevenelost ali šibkost rok, nog ali obraza, zlasti če je to samo na eni strani telesa,
English: You may take Efient with or without food.
Slovenian: Zdravilo Efient lahko vzamete z ali brez hrane.
English: Because animal reproduction studies are not always predictive of a human response, Efient should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the foetus.
Slovenian: Ker študije razmnoževanja pri živalih vedno ne napovedo odgovora pri ljudeh, lahko uporabljamo zdravilo Efient med nosečnostjo samo, če možna korist za mater upraviči možno tveganje za zarodek.
English: You should show the doctor your pack of Efient.
Slovenian: Zdravniku morate pokazati vašo škatlo zdravila Efient.
English: Requiring inotropes
Slovenian: Zahteva inotrope
English: • with body weight < 60 kg (see sections 4.2 and 4.8).
Slovenian: • s telesno maso < 60 kg (glejte poglavji 4.2 in 4.8).
English: Animal studies do not indicate direct harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3).
Slovenian: Študije na živalih ne kažejo neposrednih škodljivih učinkov na nosečnost, razvoj zarodka/ploda, porod ali postnatalni razvoj (glejte poglavje 5.3).
English: If you miss your scheduled daily dose, take Efient when you remember.
Slovenian: Če ste pozabili vzeti predvideni dnevni odmerek, vzemite zdravilo Efient, ko se spomnite.