FrancophonIA/ELRC3.0 huggingface dataset:
English: You should specifically tell your doctor if you take - medicines that may increase your risk of bleeding such as: o oral anticoagulants, medicines used to reduce blood clotting, o a non-steroidal anti-inflammatory medicine, usually used to treat painful and/or inflammatory conditions of muscle or joints, o heparin or any other injectable medicine used to reduce blood clotting, o ticlopidine, other antiplatelet agent, o a selective serotonin reuptake inhibitor (including but not restricted to fluoxetine or fluvoxamine), medicines usually used to treat depression,
Slovenian: Še posebej pomembno je, da obvestite svojega zdravnika, če jemljete - zdravila, ki lahko povečajo tveganje za krvavitve, kot so: o peroralni antikoagulanti, zdravila, ki preprečujejo nastanek krvnih strdkov, o nesteroidna protivnetna zdravila, ki se običajno uporabljajo za lajšanje bolečine in/ali vnetja mišic ali sklepov, o heparin, ali katerokoli drugo zdravilo v obliki injekcij, ki se uporablja za zmanjševanje strjevanja krvi, o tiklopidin, peroralno antiagregacijsko zdravilo, o selektivni zaviralci privzema serotonina (na primer fluoksetin ali fluvoksamin, a ne le tadva), ki se po navadi uporabljajo za zdravljenje depresije, - omeprazol ali esomeprazol, zdravila za zdravljenje težav z želodcem,
English: What Clopidogrel Zentiva looks like and contents of the pack
Slovenian: Izgled zdravila Clopidogrel Zentiva in vsebina pakiranja
English: Clopidogrel Zentiva is supplied in cardboard cartons containing 4x1, 10x1, 30x1 and 100x1 tablets in all aluminium perforated unit-dose blisters.
Slovenian: Zdravilo Clopidogrel Zentiva je na voljo so v škatlah, ki vsebujejo 4x1, 10x1, 30x1, in 100x1 tableto v perforiranih pretisnih omotih za enkratni odmerek, ki so v celoti iz aluminija.
English: If Clopidogrel Zentiva is supplied in all aluminium blisters, it does not require any special storage conditions.
Slovenian: Za shranjevanje zdravila Clopidogrel Zentiva, ki je na voljo v aluminijastih pretisnih omotih niso potrebna posebna navodila.
English: If a dose is missed: - Within less than 12 hours after regular scheduled time: patients should take the dose immediately and then take the next dose at the regular scheduled time.
Slovenian: Če bolnik izpusti odmerek: - če je zamuda manj kot 12 ur po pravem času: bolnik naj odmerek vzame takoj,
English: How to take Clopidogrel Zentiva
Slovenian: Kako jemati zdravilo Clopidogrel Zentiva
English: If you cut or injure yourself, it may take longer than usual for bleeding to stop.
Slovenian: Če doživite podaljšanje krvavitve v času jemanja zdravila Clopidogrel Zentiva Če se urežete ali poškodujete, lahko traja dlje kot običajno, da se vam krvavitev ustavi.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
Slovenian: Druga zdravila in zdravilo Clopidogrel Zentiva Obvestite svojega zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
English: Sanofi Winthrop Industrie 1, rue de la Vierge Ambarès & Lagrave F-33565 Carbon Blanc cedex France
Slovenian: Sanofi Winthrop Industrie 1, rue de la Vierge Ambarès & Lagrave F-33565 Carbon Blanc cedex Francija
English: The clinically relevant adverse reactions observed in the CAPRIE, CURE, CLARITY, COMMIT and ACTIVE-A studies are discussed below.
Slovenian: Klinično pomembni neželeni učinki, zabeleženi v študijah CAPRIE, CURE, CLARITY in COMMIT, so predstavljeni spodaj.Poleg neželenih učinkov v kliničnih študijah so bili neželeni učinki prijavljeni tudi spontano.
English: Clopidogrel Zentiva contains lactose.
Slovenian: Zdravilo Clopidogrel Zentiva vsebuje laktozo.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu/
Slovenian: Navodilo je bilo nazadnje revidirano dne <mesec LLLL> Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila : http://www.ema.europa.eu/.
English: Marketing Authorisation Holder and Manufacturers
Slovenian: Imetnik dovoljenja za promet z zdravilom in izdelovalec
English: Clopidogrel Zentiva may be taken with or without food.
Slovenian: Zdravilo Clopidogrel Zentiva skupaj s hrano in pijačo Zdravilo Clopidogrel Zentiva lahko jemljete s hrano ali brez nje.
English: Clopidogrel Zentiva 75 mg film-coated tablets Pink, round, biconvex, engraved with «75» on one side and «1171» on the other side.
Slovenian: Clopidogrel Zentiva 75 mg filmsko obložene tablete Rožnate, okrogle, bikonveksne filmsko obložene tablete, z vtisnjeno številko "75" na eni strani in "1171" na drugi strani.
English: Contact your doctor or the nearest hospital emergency department because of the increased risk of bleeding.
Slovenian: Če ste vzeli večji odmerek zdravila Clopidogrel Zentiva, kot bi smeli Zaradi povečanega tveganja krvavitve se posvetujte s svojim zdravnikom ali oddelkom najbližje bolnišnične nujne zdravniške pomoči.
English: Clopidogrel Zentiva 75 mg film-coated tablets Each film-coated tablet contains 75 mg of clopidogrel (as hydrogen sulphate).
Slovenian: Clopidogrel Zentiva 75 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 75 mg klopidogrela v obliki klopidogrelijevega hidrogensulfata.
English: Clopidogrel Zentiva contains lactose
Slovenian: Zdravilo Clopidogrel Zentiva vsebuje laktozo
English: Clopidogrel Zentiva 75-mg film-coated tablets (tablets) are round, biconvex, pink, engraved on one side with the number ‘75' and on the other side with the number ‘1171'.
Slovenian: Zdravilo Clopidogrel Zentiva 75 mg filmsko obložene tablete (tablete) so okrogle, bikonveksne, rožnate tablete, z vtisnjeno številko “75” na eni strani in številko “1171” na drugi strani.
English: Clopidogrel Zentiva 300 mg film-coated tablets Each film-coated tablet contains 300 mg of clopidogrel (as hydrogen sulphate).
Slovenian: Clopidogrel Zentiva 300 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 300 mg klopidogrela v obliki klopidogrelijevega hidrogensulfata.
English: Clopidogrel Zentiva 300 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Clopidogrel Zentiva 300 mg
English: Patients were randomized to receive either prasugrel 5 or 10 mg/d (Days 0-14) (n=1306), or prasugrel 5 or 10 mg/d (Days 0-7) then de-escalated to clopidogrel 75 mg/d (Days 8-14) (n=1304), in combination with ASA (<100 mg/day).
Slovenian: (od 0. do 14. dne) (n = 1306) bodisi na prejemanje prasugrela 5 ali 10 mg/dan (od 0. do 7. dne) s poznejšim deeskaliranjem na 75 mg klopidogrela na dan (od 8. do 14. dne) (n = 1304) v kombinaciji z ASA (< 100 mg/dan).
English: Clopidogrel Zentiva 300-mg film-coated tablets (tablets) are oblong, pink, engraved on one side with the number ‘300' and on the other side with the number ‘1332'.
Slovenian: Zdravilo Clopidogrel Zentiva 300 mg filmsko obložene tablete (tablete) so podolgovate, rožnate tablete, z vtisnjeno številko “300” na eni strani in številko “1332” na drugi strani.
English: In CURE, there was no excess in major bleeds with clopidogrel plus ASA within 7 days after coronary bypass graft surgery in patients who stopped therapy more than five days prior to surgery.
Slovenian: V CURE število velikih krvavitev s klopidogrelom in ASA ni bilo prekoračeno v 7 dneh po koronarni premostitveni operaciji pri bolnikih, ki so prenehali z zdravljenjem več kot 5 dni pred kirurškim posegom (4,4 % klopidogrel in ASA proti 5,3 % placebo in ASA).
English: Aluminium perforated unit-dose blisters in cardboard cartons containing 4x1, 10x1, 30x1 and 100x1 film-coated tablets.
Slovenian: Clopidogrel Zentiva 300 mg filmsko obložene tablete Aluminijski perforirani pretisni omoti za enkratni odmerek v kartonskih škatlah, ki vsebujejo 4 x 1, 10 x 1, 30 x 1 in 100 x 1 filmsko obloženo tableto.
English: Clopidogrel Zentiva 75 mg film-coated tablets Clopidogrel Zentiva 300 mg film-coated tablets
Slovenian: Clopidogrel Zentiva 75 mg filmsko obložene tablete Clopidogrel Zentiva 300 mg filmsko obložene tablete
English: The other ingredients are (see section 2 ‘Clopidogrel Zentiva contains lactose' and ‘Clopidogrel Zentiva contains hydrogenated castor oil'):
Slovenian: Pomožne snovi so (»glejte poglavje 2 »Zdravilo Clopidogrel Zentiva vsebuje laktozo« in »Zdravilo Clopidogrel Zentiva vsebuje hidrogeniramo ricinusovo olje«): - Jedro tablete: manitol (E421), hidrogenirano ricinusovo olje, mikrokristalna celuloza,
English: Tablet core: mannitol (E421), hydrogenated castor oil, microcrystalline cellulose, macrogol 6000 and low-substituted hydroxypropylcellulose, Tablet coating: lactose monohydrate (milk sugar), hypromellose (E464), triacetin (E1518), red iron oxide (E172) and titanium dioxide (E171), Polishing agent: carnauba wax.
Slovenian: makrogol 6000 in delno substituirana hidroksipropilceluloza - Obloga tablete: laktoza monohidrat (mlečni sladkor), hipromeloza (E464), triacetin (E1518), rdeč železov oksid (E172), titanov dioksid (E171) - Polirno sredstvo: karnauba vosek .
English: Clopidogrel Zentiva 300 mg film-coated tablets Pink, oblong, engraved with «300» on one side and «1332» on the other side.
Slovenian: Clopidogrel Zentiva 300 mg filmsko obložene tablete Rožnate, podolgovate filmsko obložene tablete z vtisnjeno številko "300" na eni strani in "1332" na drugi strani.
English: If you are breast-feeding or planning to breast-feed, talk to your doctor before taking this medicine.
Slovenian: Če dojite ali nameravate dojiti, se pred jemanjem tega zdravila posvetujte s svojim zdravnikom.
English: Clopidogrel Zentiva 75 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Clopidogrel Zentiva 75 mg
English: - If you are allergic (hypersensitive) to clopidogrel or any of the other ingredients of this medicine
Slovenian: Ne jemljite zdravila Clopidogrel Zentiva: - če ste alergični na klopidogrel ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: Fertility Clopidogrel was not shown to alter fertility in animal studies.
Slovenian: Šudije na živalih niso pokazale, da bi klopidogrel vplival na plodnost.
English: The 2x2 factorial design COMMIT trial included 45,852 patients presenting within 24 hours of the onset of the symptoms of suspected MI with supporting ECG abnormalities (i.e. ST elevation, ST depression or left bundle-branch block).
Slovenian: V študijo COMMIT z 2x2 faktorsko raziskovalno zasnovo je bilo vključenih 45.852 bolnikov v 24 urah po nastopu simptomov, ki bi lahko kazali na miokardni infarkt, z neustreznimi vrednostmi
English: - You have an irregular heartbeat, a condition called ‘atrial fibrillation', and you cannot take medicines known as ‘oral anticoagulants' (vitamin K antagonists) which prevent new clots from forming and prevent existing clots from growing.
Slovenian: Zdravnik vam bo moral predpisati tudi acetilsalicilno kislino (učinkovina, ki je prisotna v številnih zdravilih proti bolečinam in za zniževanje zvišane telesne temperature, kakor tudi za preprečevanje strjevanja krvi), - imate neredno bitje srca, motnjo, imenovano "atrijska fibrilacija", in ne morete prejemati zdravil, imenovanih "peroralni antikoagulanti" (antagonisti vitamina K), ki preprečujejo nastajanje novih krvnih strdkov in preprečujejo rast obstoječih krvnih strdkov.
English: In CLARITY, there was an overall increase in bleeding in the clopidogrel plus ASA group vs. the placebo plus ASA group .The incidence of major bleeding was similar between groups.
Slovenian: V študiji CLARITY je v skupini s klopidogrelom in ASA prišlo do splošnega povečanja krvavitev v primerjavi s skupino s placebom in ASA .
English: Other medicines and Clopidogrel Zentiva
Slovenian: Shranjevanje zdravila Clopidogrel Zentiva
English: Gastrointestinal haemorrhage, diarrhoea, abdominal pain, dyspepsia
Slovenian: Krvavitev v prebavila, driska, bolečine v trebuhu, dispepsija
English: Clopidogrel Zentiva 300 mg film-coated tablets
Slovenian: Clopidogrel Zentiva 300 mg filmsko obložene tablete
English: Clopidogrel Zentiva 300 mg tablets clopidogrel
Slovenian: IME ZDRAVILA Clopidogrel Zentiva 300 mg tablete klopidogrel
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Slovenian: B. POGOJI ALI OMEJITVE GLEDE OSKBE IN UPORABE Predpisovanje in izdaja zdravila je le na recept.
English: Clopidogrel Zentiva 75 mg film-coated tablets
Slovenian: Clopidogrel Zentiva 75 mg filmsko obložene tablete
English: Microcrystalline cellulose Hydrogenated castor oil Low substituted hydroxypropylcellulose
Slovenian: Jedro: manitol (E421) makrogol 6000 mikrokristalna celuloza hidrogenirano ricinusovo olje delno substituirana hidroksipropilceluloza
English: Clopidogrel Zentiva 75 mg tablets clopidogrel
Slovenian: IME ZDRAVILA Clopidogrel Zentiva 75 mg tablete klopidogrel
English: Clopidogrel Zentiva 300 mg film-coated tablets clopidogrel
Slovenian: Clopidogrel Zentiva 300 mg filmsko obložene tablete klopidogrel
English: Clopidogrel Zentiva 75 mg film-coated tablets clopidogrel
Slovenian: Clopidogrel Zentiva 75 mg filmsko obložene tablete klopidogrel
English: • if you have a risk of bleeding such as - a medical condition that puts you at risk of internal bleeding (such as a stomach ulcer).
Slovenian: • če imate tveganje za krvavitev, kot je: - zdravstveno stanje s tveganjem za notranjo krvavitev (kot je rana na želodcu) - krvna motnja, zaradi katere ste bolj nagnjeni k notranji krvavitvi (krvavitev v tkivih, organih ali sklepih vašega telesa) - nedavna huda poškodba - nedaven kirurški poseg (vključno na zobeh) - načrtovan kirurški poseg (vključno na zobeh) v naslednjih 7 dneh
English: PV-Lithuania@zentiva.com
Slovenian: PV-Slovenia@zentiva.com
English: EU/1/08/465/015 - Cartons of 4x1 film-coated tablets in all aluminium perforated unit-dose blisters EU/1/08/465/016 - Cartons of 30x1 film-coated tablets in all aluminium perforated unit-dose blisters EU/1/08/465/017 - Cartons of 100x1 film-coated tablets in all aluminium perforated unit-dose blisters EU/1/08/465/020 - Cartons of 10x1 film-coated tablets in all aluminium perforated unit-dose blisters
Slovenian: EU/1/08/465/016 - Škatle s 30 x 1 filmsko obloženih tablet v perforiranih pretisnih omotih za enkratni odmerek, ki so v celoti iz aluminija.
English: PV-Estonia@zentiva.com
Slovenian: PV-Latvia@zentiva.com
English: EU/1/08/465/010 - Cartons of 84 film-coated tablets in all aluminium blisters EU/1/08/465/011 - Cartons of 90 film-coated tablets in PVC/PVDC/Alu blisters EU/1/08/465/012 - Cartons of 90 film-coated tablets in all aluminium blisters EU/1/08/465/013 - Cartons of 100 film-coated tablets in PVC/PVDC/Alu blisters EU/1/08/465/014 - Cartons of 100 film-coated tablets in all aluminium blisters EU/1/08/465/018 - Cartons of 7 film-coated tablets in PVC/PVDC/Alu blisters EU/1/08/465/019 - Cartons of 7 film-coated tablets in all aluminium blisters EU/1/08/465/021 - Cartons of 50 film-coated tablets in PVC/PVDC/Alu blisters
Slovenian: Clopidogrel Zentiva 75 mg filmsko obložene tablete EU/1/08/465/001 - škatle s 14 filmsko obloženimi tabletami v PVC/PVDC/alu pretisnih omotih EU/1/08/465/002 - škatle s 14 filmsko obloženimi tabletami v aluminijastih pretisnih omotih EU/1/08/465/003 - škatle z 28 filmsko obloženimi tabletami v PVC/PVDC/alu pretisnih omotih EU/1/08/465/004 - škatle z 28 filmsko obloženimi tabletami v aluminijastih pretisnih omotih EU/1/08/465/005 - škatle s 30 filmsko obloženimi tabletami v PVC/PVDC/alu pretisnih omotih EU/1/08/465/006 - škatle s 30 filmsko obloženimi tabletami v aluminijastih pretisnih omotih EU/1/08/465/007 - škatle s 50x1 filmsko obloženimi tabletami v PVC/PVDC/alu pretisnih omotih EU/1/08/465/008 - škatle s 50x1 filmsko obloženimi tabletami v aluminijastih pretisnih omotih EU/1/08/465/009 - škatle z 84 filmsko obloženimi tabletami v PVC/PVDC/alu pretisnih omotih EU/1/08/465/010 - škatle z 84 filmsko obloženimi tabletami v aluminijastih pretisnih omotih EU/1/08/465/011 - škatle z 90 filmsko obloženimi tabletami v PVC/PVDC/alu pretisnih omotih EU/1/08/465/012 - škatle z 90 filmsko obloženimi tabletami v aluminijastih pretisnih omotih EU/1/08/465/013 - škatle s 100 filmsko obloženimi tabletami v PVC/PVDC/alu pretisnih omotih EU/1/08/465/014 - škatle s 100 filmsko obloženimi tabletam v aluminijastih pretisnih omotih EU/1/08/465/018 - škatle s 7 filmsko obloženimi tabletami v PVC/PVDC/alu pretisnih omotih EU/1/08/465/019 - škatle s 7 filmsko obloženimi tabletam v aluminijastih pretisnih omotih EU/1/08/465/021 - škatle s 50 filmsko obloženimi tabletami v PVC/PVDC/alu pretisnih omotih
English: • At the request of the European medicine Agency
Slovenian: • na zahtevo Evropske agencije za zdravila;
English: Povidone (K29/32)
Slovenian: Povidon (K29/32)
English: In that case carry on with the next dose as normal.
Slovenian: V tem primeru naj nadaljuje z naslednjim odmerkom kot običajno.
English: The 95% CI of the difference was 42.2-85.7.
Slovenian: 95 % IZ razlike je bil 42,2-85,7.
English: • a low number of a type of white blood cells.
Slovenian: • nizko število določene vrste belih krvnih celic.
English: Tmax was similar with both formulations.
Slovenian: Tmax je bil pri obeh farmacevtskih oblikah podoben.
English: Patients then received stiripentol in an open fashion.
Slovenian: Nato so bolniki prejemali stiripentol v odprti fazi.
English: Children aged less than 3 years
Slovenian: Otroci, mlajši od 3 let
English: AT/BE/BG/CY/DK/EE/EL/ES/FR/HR/HU/IE/IS/IT/LT/LU/LV/MT/NL/PL/PT/SI/UK Biocodex
Slovenian: AT/BE/BG/CY/DK/EE/EL/ES/FR/HU/IE/IS/IT/LT/LU/LV/MT/NL/PL/PT/SI/UK Biocodex
English: • sensitivity to light;
Slovenian: • občutljivost za svetlobo;
English: It is important that your child takes this medicine regularly at the same time each day.
Slovenian: Pomembno je, da vaš otrok jemlje to zdravilo redno, ob isti uri vsak dan.
English: NN: {number} [national reimbursement number or other national number identifying the medicinal product]
Slovenian: NN: {številka} [nacionalna številka povračila stroškov za zdravilo ali druga nacionalna številka za identifikacijo zdravila]
English: Long-term data has not been collected in a sufficient number of adults to confirm maintenance of effect in this population.
Slovenian: Podatki daljšega časovnega obdobja niso bili zbrani pri zadostnem številu odraslih, da bi lahko potrdili vzdrževanje učinka pri tej populaciji.
English: These studies in mice and rabbits were undertaken prior to the introduction of Good Laboratory Practice requirements.
Slovenian: Te študije pri miših in kuncih so bile opravljene pred uvedbo skladnosti z zahtevami dobre laboratorijske prakse.
English: Many of these interactions have been partially confirmed by in vitro studies and in clinical trials.
Slovenian: Veliko navedenih interakcij je bilo delno potrjenih v študijah in vitro ter v kliničnih preskušanjih.
English: No clinical data are available, potential risk for human is unknown.
Slovenian: Klinični podatki niso na voljo, možno tveganje za ljudi ni znano.
English: Patients aged ≥ 18 years of age
Slovenian: Bolniki, stari ≥ 18 let
English: Glucose may be harmful to the teeth.
Slovenian: Glukoza lahko škoduje zobni sklenini.
English: It may harm them, even if their symptoms are the same as your child's.
Slovenian: Njim bi lahko celo škodovalo, čeprav imajo znake bolezni, ki so podobni kot pri vašemu otroku.
English: Combinations requiring precautions
Slovenian: Kombinacije, ki zahtevajo previdnostne ukrepe
English: However, the situation is different if the vomiting occurs more than one hour after medicine intake because stiripentol is quickly absorbed.
Slovenian: Vendar pa to ne velja, če do bruhanja pride več kot eno uro po jemanju zdravila, saj se stiripentol hitro absorbira.
English: The daily dosage may be administered in 2 or 3 divided doses.
Slovenian: Dnevni odmerek se lahko razdeli v 2 ali 3 odmerke.
English: Adverse reactions encountered most often are as follows: 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: Neželeni učinki so razvrščeni 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), neznani (ni jih mogoče oceniti iz razpoložljivih podatkov).
English: Trojicné námestie 13 82106 Bratislava Slovakia
Slovenian: Trojicné námestie 13 82106 Bratislava
English: Check with your child's doctor.
Slovenian: Posvetujte se z otrokovim zdravnikom.
English: Although other factors, e.g. the epilepsy, can contribute, available evidence suggests that this increase, to a large extent, is caused by the treatment.
Slovenian: Čeprav lahko k temu prispevajo drugi dejavniki (npr. epilepsija), dokazi, ki so na voljo, kažejo, da to povečanje v veliki meri povzročijo zdravila.
English: The data were best fitted with a one compartment model with first order absorption and elimination processes.
Slovenian: Podatke je najbolje opisal enoprostorni model prvega reda absorpcije in izločanja.
English: Sachets are made with a composite paper/aluminium/polyethylene film.
Slovenian: Vrečice so izdelane iz kompozita papir/aluminij/polietilenski film.
English: Other medicines and Diacomit
Slovenian: Druga zdravila in Diacomit
English: Carcinogenicity studies gave negative results in the rat.
Slovenian: Študije karcinogenosti pri podganah so dale negativne rezultate.
English: - medicines containing:
Slovenian: - zdravila, ki vsebujejo:
English: Stiripentol must always be taken with food as it degrades rapidly in an acidic environment (e.g. exposure to gastric acid in an empty stomach).
Slovenian: Stiripentol je treba vedno vzeti s hrano, saj v kislem okolju hitro razpade (npr. izpostavitev želodčni kislini v praznem želodcu).
English: Therefore, it may be harmful for people with phenylketonuria.
Slovenian: Zato je lahko škodljiv osebam, ki imajo fenilketonurijo.
English: Thus, there would be no need for a new intake or for an adjustment of the next dose.
Slovenian: Zato ponovno jemanje ali prilagoditev naslednjega odmerka ni potrebna.
English: The dose will be adjusted by the doctor according to your child's condition.
Slovenian: Odmerek bo zdravnik prilagodil glede na stanje vašega otroka.
English: The absolute bioavailability of stiripentol is not known since an intravenous formulation is not available for testing.
Slovenian: Absolutna biološka razpoložljivost stiripentola ni znana, saj intravenska oblika ni na voljo za preskušanje.
English: Date of latest renewal: 08 January 2014
Slovenian: Datum prve odobritve: 4. januar 2007 Datum zadnjega podaljšanja: 8. januar 2014
English: System Organ Class (MedDRA terminology)
Slovenian: Organski sistem (izrazoslovje MedDRA)
English: The half-life of elimination was in the range of 4.5 hours to 13 hours, increasing with dose.
Slovenian: Razpolovna doba izločanja je bila v razponu od 4,5 ure do 13 ur in se je podaljševala z odmerkom.
English: Use in combination with stiripentol is not recommended.
Slovenian: Uporaba v kombinaciji s stiripentolom ni priporočljiva.
English: Substances interfering with CYP enzymes
Slovenian: Snovi, ki ovirajo delovanje encimov CYP
English: A past history of psychoses in the form of episodes of delirium.
Slovenian: Psihoza v obliki epizod delirija v anamnezi.
English: In case of vomiting within the first few minutes of intake it is assumed that no medicine has been absorbed and a new dose should be given.
Slovenian: Če v prvih nekaj minutah po jemanju zdravila pride do bruhanja, se šteje, da zdravilo ni bilo absorbirano, zato je treba dati nov odmerek.
English: No studies on the effects on the ability to drive and use machines have been performed.
Slovenian: Študije o vplivu na sposobnost upravljanja vozil in strojev niso bile izvedene.
English: No impact on fertility was detected in animal studies (see section 5.3).
Slovenian: V študijah pri živalih ni bilo opaženih nikakršnih vplivov na plodnost (glejte poglavje 5.3).
English: If your child forgets to take a dose, he or she should take it as soon as you remember unless it is time for the next dose.
Slovenian: Če vaš otrok pozabi vzeti odmerek, ga naj vzame takoj, ko se spomnite, razen če je čas za naslednji odmerek.
English: (involuntary muscle contractions).
Slovenian: (nehoteni mišični krči).