FrancophonIA/ELRC3.0 huggingface dataset:
English: • you are allergic (hypersensitive) to the active substance (eslicarbazepine acetate), to other carboxamide derivatives (e.g. carbamazepine or oxcarbazepine, medicines used to treat epilepsy) or to any of the other ingredients
Slovenian: • ste alergični (preobčutljivi) na zdravilno učinkovino (eslikarbazepinacetat), druge derivate karboksamida
English: Exalief is not recommended in patients with severe liver problems.
Slovenian: Zdravilo Exalief ni priporočeno pri bolnikih s hudimi težavami z jetri.
English: INFORMATION IN BRAILLE Exalief 600 mg (outer pack only)
Slovenian: PODATKI V BRAILLOVI PISAVI Exalief 600 mg (samo zunanja ovojnina)
English: Hyponatraemia has been reported as an adverse reaction in less than 1% of patients treated with Exalief.
Slovenian: Pri manj kot 1 % bolnikov, ki so prejemali zdravilo Exalief, se je kot neželeni učinek pojavila hiponatriemija.
English: Bioavailability may be assumed as high because the amount of metabolites recovered in urine corresponded to more than 90% of an eslicarbazepine acetate dose.
Slovenian: Količina presnovkov, ki so jih zaznali v urinu, je ustrezala več kot 90 % odmerka eslikarbazepinacetata, zato biološko uporabnost lahko štejemo za veliko.
English: INFORMATION IN BRAILLE Exalief 800 mg (outer pack only)
Slovenian: PODATKI V BRAILLOVI PISAVI Exalief 800 mg (samo zunanja ovojnina)
English: Dyspepsia, gastritis, abdominal pain, dry mouth, abdominal discomfort, abdominal distension, duodenitis, epigastric discomfort, gingival hyperplasia, gingivitis , irritable bowel syndrome, melaena, odynophagia, stomach discomfort, stomatitis, toothache
Slovenian: Bolezni prebavil dispepsija, gastritis, bolečine v trebuhu, suha usta, neprijeten občutek v trebuhu, abdominalna distenzija, duodenitis, neprijeten občutek v epigastriju, gingivalna hiperplazija, gingivitis, sindrom iritabilnega kolona, melena, odinofagija, neprijeten občutek v želodcu, stomatitis, zobobol pankreatitis
English: Exalief 600 mg tablets are white and oblong.
Slovenian: Tablete Exalief 600 mg so bele in podolgovate.
English: Exalief 800 mg tablets are white and oblong.
Slovenian: Tablete Exalief 800 mg so bele in podolgovate.
English: • Hypersensitivity
Slovenian: • preobčutljivost,
English: INFORMATION IN BRAILLE Exalief 800 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Exalief 800 mg
English: Exalief 400 mg tablets are packaged in ALU/ALU or ALU/PVC blisters placed into cardboard boxes containing 7, 14 or 28 tablets.
Slovenian: Tablete Exalief 400 mg so pakirane v pretisne omote iz ALU/ALU ali ALU/PVC, vložene v kartonske škatle, ki vsebujejo 7, 14 ali 28 tablet.
English: The tablets are packaged in blisters in cardboard boxes containing 30 or 60 tablets, and in HDPE bottles with child resistant closure in cardboard boxes containing 90 tablets.
Slovenian: Tablete so pakirane v pretisne omote v kartonskih škatlah, ki vsebujejo 30 ali 60 tablet, in v steklenice iz HDPE z za otroke varno zaporko v kartonskih škatlah, ki vsebujejo 90 tablet.
English: INFORMATION IN BRAILLE Exalief 600 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Exalief 600 mg
English: Exalief 600 mg tablets are packed in ALU/ALU or ALU/PVC blisters placed into cardboard boxes containing 30 or 60 tablets.
Slovenian: Tablete Exalief 600 mg so pakirane v pretisne omote iz ALU/ALU ali ALU/PVC, vložene v kartonske škatle, ki vsebujejo 30 ali 60 tablet.
English: • Liver problems
Slovenian: • težave z jetri,
English: • The active substance is eslicarbazepine acetate.
Slovenian: • Zdravilna učinkovina je eslikarbazepinacetat.
English: The use of eslicarbazepine acetate is associated with increase in the PR interval.
Slovenian: V kliničnih študijah z eslikarbazepinacetatom so opazili podaljšanje intervala PR.
English: Read the package leaflet before use.
Slovenian: 90 tablet peroralna uporaba Pred uporabo preberite priloženo navodilo.
English: In vivo eslicarbazepine showed an inducing effect on the metabolism of medicinal products that are mainly eliminated by metabolism through CYP3A4.
Slovenian: Izkazalo se je, da ima eslikarbazepin in vivo spodbujevalni učinek na presnovo zdravil, ki se izločajo predvsem prek sistema CYP3A4.
English: Exalief 800 mg tablets are packed in HDPE bottles with polypropylene child resistant closure, placed into cardboard boxes, containing 90 tablets.
Slovenian: Tablete Exalief 800 mg so pakirane v steklenice iz HDPE s polipropilensko za otroke varno zaporko, vložene v kartonske škatle, ki vsebujejo 90 tablet.
English: Exalief is not recommended if you have severe kidney problems.
Slovenian: Uporaba zdravila Exalief ni priporočena, če imate hude težave z ledvicami.
English: Vision disturbance, oscillopsia, binocular eye movement disorder, ocular hyperaemia, saccadic eye movement, eye pain
Slovenian: Očesne bolezni diplopija*, zamegljen vid motnje vida, oscilopsija, motnje binokularnega gibanja oči, očesna hiperemija, sakadirano gibanje oči, bolečine v očeh
English: • Inflamed gums, mouth inflammation or toothache
Slovenian: • vnete dlesni, vnetje v ustih ali zobobol,
English: If you do, you are at risk of having more seizures.
Slovenian: Drugače obstaja tveganje za pogostejše epileptične napade.
English: Exalief 600 mg tablets are packed in HDPE bottles with polypropylene child resistant closure, placed into cardboard boxes, containing 90 tablets.
Slovenian: Tablete Exalief 600 mg so pakirane v steklenice iz HDPE s polipropilensko za otroke varno zaporko, vložene v kartonske škatle, ki vsebujejo 90 tablet.
English: Administration of eslicarbazepine acetate 1,200 mg once daily to female subjects using a combined oral contraceptive showed an average decrease of 37% and 42% in systemic exposure to levonorgestrel and ethinyloestradiol, respectively, most likely caused by an induction of CYP3A4.
Slovenian: Pri uporabi 1.200 mg eslikarbazepinacetata enkrat na dan pri ženskah, ki uporabljajo kombinirana peroralna kontraceptive, je prišlo do povprečnega 37-odstotnega zmanjšanja sistemske izpostavljenosti levonorgestrelu in 42-odstotnega zmanjšanja sistemske izpostavljenosti etinilestradiolu, ki je najverjetneje bilo posledica indukcije CYP3A4.
English: The pharmacokinetics and metabolism of eslicarbazepine acetate were evaluated in healthy subjects and moderately liver-impaired patients after multiple oral doses.
Slovenian: Po večkratnih peroralnih odmerkih so pri zdravih osebah in pri bolnikih z zmerno jetrno okvaro ocenili farmakokinetiko in presnovo eslikarbazepinacetata.
English: NAME OF THE MEDICINAL PRODUCT Exalief 800 mg tablets
Slovenian: IME ZDRAVILA Exalief 800 mg tablete
English: NAME OF THE MEDICINAL PRODUCT Exalief 400 mg tablets
Slovenian: IME ZDRAVILA Exalief 400 mg tablete
English: • Worsening of seizures
Slovenian: • poslabšanje epileptičnih napadov,
English: Suicidal ideation and behaviour have been reported in patients treated with anti-epileptic active substances in several indications.
Slovenian: Pri bolnikih, ki so se zaradi različnih indikacij zdravili z antiepileptiki, so poročali o samomorilnih mislih in vedenju.
English: A meta-analysis of randomised placebo controlled trials of anti-epileptic medicinal products has also shown a small increased risk of suicidal ideation and behaviour.
Slovenian: Majhno povečanje tveganja za pojav samomorilnega razmišljanja in vedenja je pokazala tudi metaanaliza randomiziranih s placebom nadzorovanih kliničnih preskušanj antiepileptikov.
English: NAME OF THE MEDICINAL PRODUCT Exalief 600 mg tablets
Slovenian: IME ZDRAVILA Exalief 600 mg tablete
English: Specialist advice should be given to women who are likely to become pregnant or who are of child-bearing potential.
Slovenian: Ženske, pri katerih obstaja verjetnost, da bodo zanosile, in ženske v rodni dobi, se morajo posvetovati s specialistom.
English: White circular biconvex tablets, engraved ‘ESL 400'on one side and scored on the other side.
Slovenian: Bele, okrogle, bikonveksne tablete z vtisnjenim napisom ‘ESL 400' na eni strani in zarezo na drugi strani.
English: Haemodialysis removes eslicarbazepine acetate metabolites from plasma.
Slovenian: Presnovke eslikarbazepinacetata lahko iz plazme odstranimo s hemodializo.
English: Thus, interactions can arise when coadministering high doses of eslicarbazepine acetate with medicinal products that are mainly metabolised by CYP2C19.
Slovenian: Eslikarbazepin zavira delovanje CYP2C19, zato lahko pride do interakcij pri sočasni uporabi velikih odmerkov eslikarbazepinacetata in zdravil, ki jih večinoma presnavlja CYP2C19.
English: Investigations
Slovenian: DODATNE INFORMACIJE
English: Side effects associated with this ECG abnormality (e.g. fainting and slowing of heart beat) may occur.
Slovenian: Uporaba zdravila Exalief je povezana z nenormalnim pojavom pri elektrokardiogramu (EKG), imenovanim povečanje intervala PR. Lahko se pojavijo neželeni učinki, povezani s tem pojavom (npr. omedlevica in upočasnitev srčnega utripa).
English: Thus, an increase in the dose of the medicinal products that are mainly metabolised through CYP3A4 may be required, when used concomitantly with Exalief.
Slovenian: Zato bo pri sočasni uporabi z zdravilom Exalief morda treba povečati odmerek zdravil, ki se presnavljajo s CYP3A4.
English: • Having falls
Slovenian: • padci,
English: Liver disorder
Slovenian: Ledvična okvara
English: White oblong tablets, engraved ‘ESL 800'on one side and scored on the other side.
Slovenian: Bele, podolgovate tablete z vtisnjenim napisom ‘ESL 800' na eni strani in zarezo na drugi strani.
English: Nervous system disorders
Slovenian: Bolezni živčevja omotica*,
English: White oblong tablets, engraved ‘ESL 600'on one side and scored on the other side.
Slovenian: Bele, podolgovate tablete z vtisnjenim napisom ‘ESL 600' na eni strani in zarezo na drugi strani.
English: Each tablet contains 800 mg of eslicarbazepine acetate.
Slovenian: Ena tableta vsebuje 800 mg eslikarbazepinacetata.
English: No cases of serious cutaneous reactions have been reported with eslicarbazepine acetate.
Slovenian: Pri uporabi eslikarbazepinacetata niso poročali o primerih resnih kožnih reakcij.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 800 mg of eslicarbazepine acetate.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena tableta vsebuje 800 mg eslikarbazepinacetata.
English: • Diarrhoea
Slovenian: • zaspanost,
English: MARKETING AUTHORISATION NUMBER(S) EU/1/09/520/007-011
Slovenian: ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/09/520/007-011
English: HPDE bottles carton and HPDE bottles of 90 tablets
Slovenian: PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI Škatla za steklenice iz HPDE in steklenice iz HPDE, ki vsebujejo 90 tablet
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS ALU/ALU blister
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU Pretisni omot iz ALU/ALU
English: Each tablet contains 400 mg of eslicarbazepine acetate.
Slovenian: Ena tableta vsebuje 400 mg eslikarbazepinacetata.
English: Each tablet contains 600 mg of eslicarbazepine acetate.
Slovenian: Ena tableta vsebuje 600 mg eslikarbazepinacetata.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 600 mg of eslicarbazepine acetate.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena tableta vsebuje 600 mg eslikarbazepinacetata.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/09/520/001-006
Slovenian: ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/09/520/001-006
English: The pharmacokinetics of eslicarbazepine has not been evaluated in patients with severe hepatic impairment.
Slovenian: Pri bolnikih s hudo jetrno okvaro farmakokinetike eslikarbazepina niso ocenili.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/09/520/012-020
Slovenian: ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/09/520/012-020
English: Respiratory, thoracic and mediastinal disorders
Slovenian: Bolezni jeter, žolčnika in žolčevodov bolezni jeter
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 400 mg of eslicarbazepine acetate.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena tableta vsebuje 400 mg eslikarbazepinacetata.
English: Eslicarbazepine acetate and its active metabolites prevented the development of seizures in nonclinical models predictive of anticonvulsant efficacy in man.
Slovenian: V nekliničnih modelih, s katerimi je mogoče napovedati učinkovitost antiepileptikov pri človeku, so eslikarbazepinacetat in njegovi aktivni presnovki preprečili razvoj epileptičnih napadov.
English: Nocturia, urinary tract infection
Slovenian: Bolezni sečil nikturija, okužba sečil
English: • Agitated
Slovenian: • agitacija,
English: Central nervous symptoms such as vertigo, walking instability and hemi-paresis have been observed with accidental Exalief overdose.
Slovenian: Pri nenamernem prevelikem odmerjanju zdravila Exalief so opazili simptome, povezane z osrednjim živčevjem, kot so vrtoglavica, nestabilnost pri hoji in hemipareza.
English: Asthenia, malaise, chills, oedema peripheral, adverse drug reaction, peripheral coldness
Slovenian: Splošne težave in spremembe na mestu aplikacije motnje pri hoji sstenija, slabotnost, mrzlica, periferni edem, neželene reakcije na zdravilo, hladne okončine
English: MARKETING AUTHORISATION NUMBER(S) EU/1/09/520/020
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/09/520/020
English: MARKETING AUTHORISATION NUMBER(S) EU/1/09/520/011
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/09/520/011
English: No second or higher degree AV block was seen in eslicarbazepine acetate treated patients.
Slovenian: Pri bolnikih, ki so prejemali eslikarbazepinacetat, AV-bloka druge ali večje stopnje niso opazili.
English: Please talk to your doctor if you are unsure about the dose you should be taking.
Slovenian: Če ste negotovi glede odmerka, ki bi ga morali prejemati, se posvetujte z zdravnikom.
English: • Feeling sick or vomiting
Slovenian: • splošno slabo počutje ali mrzlica,
English: The tablets have ‘ESL 400'engraved on one side and are scored on the other side.
Slovenian: Na eni strani je vtisnjen napis ‘ESL 400', na drugi pa je zareza.
English: Reproductive system and breast disorders
Slovenian: Motnje reprodukcije in dojk neredna menstruacija
English: • Headache
Slovenian: • driska,
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 800 mg of eslicarbazepine acetate.
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena tableta vsebuje 800 mg eslikarbazepinacetata.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 400 mg of eslicarbazepine acetate.
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena tableta vsebuje 400 mg eslikarbazepinacetata.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 600 mg of eslicarbazepine acetate.
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena tableta vsebuje 600 mg eslikarbazepinacetata.
English: Folic acid supplementation is recommended before and during pregnancy.
Slovenian: Pred nosečnostjo in med njo je priporočljivo dajati nadomestke folne kisline.
English: After the Commission Decision the Member State Competent Authorities will update the product information as required
Slovenian: Po odločbi komisije bo pristojen organ države članice v skladu z odločbo po potrebi posodobil informacije o izdelku.
English: Pharma Gyógyszerkereskedel mi Kft.
Slovenian: C. P. Pharma Gyógyszerkereskedel mi Kft.
English: 4.8 Undesirable effects {To be completed nationally}.
Slovenian: 4.8 Neželeni učinki {Izpolni država članica}.
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM(S), STRENGTH(S) OF THE MEDICINAL PRODUCT(S), ROUTE(S) OF ADMINISTRATION, APPLICANT(S) / MARKETING AUTHORISATION HOLDER(S) IN THE MEMBER STATES
Slovenian: DODATEK I SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, POTI UPORABE ZDRAVILA , PREDLAGATELJEV/IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH
English: Cohort B included 24 children, 10 to 17 years of age and at Tanner Stage ≥2.
Slovenian: Skupina B je vključevala 24 otrok, starih od 10 do 17 let in s stopnjo ≥ 2 po Tannerju.
English: ANNEX II AMENDMENTS TO THE SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
Slovenian: DODATEK II DOPOLNILA POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA, OZNAČEVANJA IN NAVODILA ZA UPORABO
English: - This medicine has been prescribed for you.
Slovenian: - To zdravilo je bilo predpisano vam osebno in ga ne smete dajati drugim.
English: Important information about some of the ingredients of {PRODUCT NAME} If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Slovenian: Če vam je zdravnik povedal, da imate intoleranco za nekatere sladkorje, se pred uporabo tega zdravila posvetujte s svojim zdravnikom.
English: 5.3 Preclinical safety data {To be completed nationally}.
Slovenian: 5.3 Predklinični podatki o varnosti {Izpolni država članica}.
English: Magnesium stearate Hydroxypropyl cellulose Amylum pregelificatum Mannitol (E421) Aspartame (E951) Sucralose (E955) Grape flavour
Slovenian: 6.1 Seznam pomožnih snovi kalcijev karbonat mikrokristalna celuloza premreženi natrijev karmelozat polisorbat 80 magnezijev stearat hidroksipropilceluloza predgelirani škrob manitol (E421) aspartam (E951) sukraloza (E955) grozdna aroma
English: WHAT {PRODUCT NAME} IS AND WHAT IT IS USED FOR {To be completed nationally}.
Slovenian: KAJ JE ZDRAVILO X IN ZA KAJ GA UPORABLJAMO {Izpolni država članica}.
English: − Paediatric: Pharmacokinetic data in the paediatric population are not available.
Slovenian: − Otroci: Farmakokinetičnih podatkov za otroke ni.
English: Each {PRODUCT NAME} 10 mg chewable tablet contains 1.25 mg aspartame.
Slovenian: Ena {(Lastniško) ime}10 mg žvečljiva tableta vsebuje 1,25 mg aspartama.
English: In an openlabel, 8-week study, Tanner Stage 1 (N=15) and Tanner Stage ≥2 (N=24) paediatric patients (ages 6-17 years) with heterozygous familial hypercholesterolemia and baseline LDL-C ≥4 mmol/L were treated with 5 or 10 mg of chewable or 10 or 20 mg of film-coated atorvastatin tablets once daily, respectively.
Slovenian: V odprti 8-tedenski študiji so pediatrični bolniki s stopnjo 1 po Tannerju (n = 15) in stopnjo ≥ 2 (n = 24) po Tannerju, stari od 6 do 17 let, z družinsko heterozigotno familiarno hiperholesterolemijo in izhodiščnim holesterolom LDL ≥ 4 mmol/l dobivali enkrat na dan 5 ali 10 mg atorvastatina v žvečljivih tabletah oz. 10 ali 20 mg atorvastatina v filmsko obloženih tabletah.
English: What {PRODUCT NAME} is and what it is used for Before you take {PRODUCT NAME} How to take {PRODUCT NAME} Possible side effects
Slovenian: Kaj je zdravilo X in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo X Kako jemati zdravilo X
English: In a double-blind, placebo controlled study followed by an open-label phase, 187 boys and postmenarchal girls 10-17 years of age (mean age 14.1 years) with heterozygous familial hypercholesterolaemia (FH) or severe hypercholesterolaemia were randomised to atorvastatin (n=140) or placebo (n=47) for 26 weeks and then all received atorvastatin for 26 weeks..
Slovenian: V dvojno slepi, s placebom nadzorovani študiji, ki ji je sledila odprta faza, so 187 fantov in deklet (po nastopu menstruacije), starih od 10 do 17 let (povprečna starost 14,1 leta) s heterozigotno familiarno hiperholesterolemijo (FH) ali hudo hiperholesterolemijo za 26 tednov randomizirali na atorvastatin (n = 140) ali placebo (n = 47), potem pa so vsi še 26 tednov dobivali atorvastatin.
English: Each {PRODUCT NAME} 40 mg chewable tablet contains 5 mg aspartame.
Slovenian: Ena {(Lastniško) ime}40 mg žvečljiva tableta vsebuje 5 mg aspartama.
English: MARKETING AUTHORISATION HOLDER [To be completed nationally] [See Annex I - To be completed nationally] {Name and address}
Slovenian: IMETNIK DOVOLJENJA ZA PROMET [Izpolni država članica] [Glejte Dodatek I - Izpolni država članica] {Ime in naslov}
English: Each {PRODUCT NAME} 20 mg chewable tablet contains 2.5 mg aspartame.
Slovenian: Ena {(Lastniško) ime}20 mg žvečljiva tableta vsebuje 2,5 mg aspartama.
English: OTHER SPECIAL WARNING(S), IF NECESSARY
Slovenian: DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA [Izpolni država članica].
English: The mean achieved LDL-C value was 3.38 mmol/l (range: 1.81-6.26 mmol/l) in the atorvastatin group compared to 5.91 mmol/l (range: 3.93-9.96 mmol/l) in the placebo group during the 26-week double-blind phase.
Slovenian: Atorvastatin je med 26tedensko dvojno slepo fazo pomembno zmanjšal plazemsko koncentracijo celotnega holesterola, holesterola LDL, trigliceridov in apolipoproteina B. Med 26-tedensko dvojno slepo fazo je bila povprečna dosežena vrednost holesterola LDL v skupini z atorvastatinom 3,38 mmol/l (razpon: 1,81-6,26 mmol/l) in 5,91 mmol/l (razpon: 3,93-9,96 mmol/l) v skupini s placebom.
English: Atorvastatin significantly decreased plasma levels of total-C, LDL-C, triglycerides, and apolipoprotein B during the 26 week double-blind phase.
Slovenian: Povprečne vrednosti holesterola LDL, trigliceridov, holesterola VLDL in apolipoproteina B so se pri vseh preiskovancih zmanjšale do 2. tedna.
English: − {To be completed nationally}.
Slovenian: − {Izpolni država članica}.
English: MARKETING AUTHORISATION HOLDER [To be completed nationally] [See Annex I - To be completed nationally] {Name and address} <{tel}> <{fax}> <{e-mail}>
Slovenian: IMETNIK DOVOLJENJA ZA PROMET [Izpolni država članica] [Glejte Dodatek I - Izpolni država članica] {Ime in naslov} <{tel.}>
English: How to store {PRODUCT NAME} Further information
Slovenian: Shranjevanje zdravila X Dodatne informacije
English: White to off-white, round chewable tablets with pink to purple specks debossed "20" on one side and "Pfizer" on the other measuring 8.7 mm in diameter.
Slovenian: Tablete imajo na eni strani vtisnjeno oznako "20" in na drugi "Pfizer" ter v premeru merijo 8,7 mm.
English: White to off-white, round chewable tablets with pink to purple specks, debossed "40" on one side and "Pfizer" on the other measuring 10.3 mm in diameter.
Slovenian: Tablete imajo na eni strani vtisnjeno oznako "40" in na drugi "Pfizer" ter v premeru merijo 10,3 mm.
English: White to off-white, round chewable tablets with pink to purple specks, debossed "10" on one side and “Pfizer” on the other measuring 7.1 mm in diameter.
Slovenian: Tablete imajo na eni strani vtisnjeno oznako "10" in na drugi "Pfizer" ter v premeru merijo 7,1 mm.
English: INFORMATION IN BRAILLE {PRODUCT NAME} 20 mg chewable tablets
Slovenian: PODATKI V BRAILLOVI PISAVI {(Lastniško) ime} 20 mg žvečljive tablete
English: INFORMATION IN BRAILLE {PRODUCT NAME} 10 mg chewable tablets
Slovenian: PODATKI V BRAILLOVI PISAVI {(Lastniško) ime} 10 mg žvečljive tablete
English: INFORMATION IN BRAILLE {PRODUCT NAME} 40 mg chewable tablets
Slovenian: PODATKI V BRAILLOVI PISAVI {(Lastniško) ime} 40 mg žvečljive tablete
English: {PRODUCT NAME} 10 mg chewable tablets Atorvastatin calcium [See Annex I - To be completed nationally]
Slovenian: {(Lastniško) ime} 10 mg žvečljive tablete atorvastatin [Glejte Dodatek I - Izpolni država članica]
English: {PRODUCT NAME} 40 mg chewable tablets Atorvastatin calcium [See Annex I - To be completed nationally]
Slovenian: {(Lastniško) ime} 40 mg žvečljive tablete atorvastatin [Glejte Dodatek I - Izpolni država članica]
English: {PRODUCT NAME} 20 mg chewable tablets Atorvastatin calcium [See Annex I - To be completed nationally]
Slovenian: {(Lastniško) ime} 20 mg žvečljive tablete atorvastatin [Glejte Dodatek I - Izpolni država članica]
English: What {PRODUCT NAME} looks like and contents of the pack {PRODUCT NAME} 40 mg chewable tablets are white to off-white with pink to purple specks with a round shape.
Slovenian: Izgled zdravila X in vsebina pakiranja {(Lastniško) ime} 40 mg žvečljive tablete so bele do umazano bele, okrogle žvečljive tablete z rožnatimi do vijoličastimi lisami.
English: NAME OF THE MEDICINAL PRODUCT [See Annex I - To be completed nationally] {PRODUCT NAME} 20 mg chewable tablet
Slovenian: IME ZDRAVILA [Glejte Dodatek I - Izpolni država članica] {(Lastniško) ime} 20 mg žvečljiva tableta
English: NAME OF THE MEDICINAL PRODUCT {PRODUCT NAME} 20 mg chewable tablets Atorvastatin
Slovenian: IME ZDRAVILA {(Lastniško) ime} 20 mg žvečljive tablete atorvastatin