FrancophonIA/ELRC3.0 huggingface dataset:
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: Your doctor will adapt the dosage at intervals of 4 weeks or more.
Slovenian: Zdravnik bo odmerek prilagajal v presledku štirih tednov ali več.
English: Developmental safety in the paediatric population has not been established (see section 4.8).
Slovenian: Varnost za razvoj pri pediatrični populaciji ni ugotovljena (glejte poglavje 4.8).
English: Atorvastatin is not indicated in the treatment of patients below the age of 10 years.
Slovenian: Atorvastatin ni indiciran za zdravljenje bolnikov, mlajših od 10 let.
English: There is currently limited experience with respect to longterm safety in the paediatric population.
Slovenian: Trenutno je malo izkušenj z dolgoročno varnostjo v pediatrični populaciji.
English: The study lasted 3 years: LDL-cholesterol was lowered by 36%.
Slovenian: Študija je trajala 3 leta: vrednost holesterola LDL se je znižala za 36 %.
English: Drug-drug interaction studies have only been performed in adults.
Slovenian: Študije medsebojnega delovanja zdravil so bile opravljene samo pri odraslih.
English: If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Slovenian: - Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta.
English: The extent of interactions in the paediatric population is not known.
Slovenian: Obseg medsebojnih delovanj pri pediatrični populaciji ni znan.
English: The long-term efficacy of atorvastatin therapy in childhood to reduce morbidity and mortality in adulthood has not been established.
Slovenian: Dolgotrajna učinkovitost zdravljenja z atorvastatinom v otroštvu za zmanjšanje obolevnosti in umrljivosti v odrasli dobi ni ugotovljena.
English: The National Health Authorities shall ensure the following conditions are fulfilled by the Marketing Authorisation Holder:
Slovenian: Nacionalne zdravstvene oblasti morajo zagotoviti, da bo imetnik dovoljenja za promet z zdravilom zadostil naslednjim pogojem:
English: A total of 39 children and adolescents, 6 to 17 years of age, were enrolled.
Slovenian: Vključenih je bilo skupno 39 otrok in mladostnikov, starih od 6 do 17 let.
English: • Submit a Risk Management Plan (or its update) for Sortis and associated names at National level, taking into account the new paediatric data and the CHMP recommendations.
Slovenian: • Vložil načrt za obvladovanje tveganja (ali njegovo posodobitev) za zdravilo Sortis in povezana imena na nacionalni ravni, kjer bo upošteval nove pediatrične podatke in priporočila Odbora za zdravila za uporabo v humani medicini (CHMP).
English: There is limited experience in children between 6-10 years of age (see section 5.1).
Slovenian: Pri otrocih v starosti od 6 do 10 let je izkušenj malo (glejte poglavje 5.1).
English: United Kingdom Pfizer Ireland Pharmaceuticals,
Slovenian: Združeno kraljestvo Pfizer Ireland Pharmaceuticals,
English: For subjects whose dose was doubled, additional decreases were observed as early as 2 weeks, at the first assessment, after dose escalation.
Slovenian: Pri preiskovancih, ki so jim odmerek podvojili, so dodatno zmanjšanje ugotovili že po dveh tednih, na prvi kontroli, po povečanju odmerka.
English: Safety information for paediatric patients treated with doses above 20 mg, corresponding to about 0.5 mg/kg, is limited.
Slovenian: Informacij o varnosti zdravila pri pediatričnih bolnikih, ki so prejemali odmerke nad 20 mg, kar ustreza približno 0,5 mg/kg, je malo.
English: [To be completed nationally] {Name and Address} <{tel}> <{fax}> <{e-mail}>
Slovenian: [Izpolni država članica] {Ime in naslov} <{tel.}> <{fax}> <{e-mail}>
English: Prevention of cardiovascular events in adult patients estimated to have a high risk for a first cardiovascular event (see Section 5.1), as an adjunct to correction of other risk factors.
Slovenian: Preprečevanje srčnožilnih dogodkov pri bolnikih, za katere so ocenili, da pri njih obstaja visoko tveganje za prvi srčnožilni dogodek (glejte poglavje 5.1), kot dodatek k obvladovanju ostalih dejavnikov tveganja.
English: 4.5 Interaction with other medicinal products and other forms of interaction {To be completed nationally}.
Slovenian: 4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij {Izpolni država članica}.
English: This medicine is available as 5 mg, 10 mg, 20 mg and 40 mg chewable tablets and 10 mg, 20 mg, 40 mg and 80 mg film-coated tablets.
Slovenian: To zdravilo je na voljo kot 5 mg, 10 mg, 20 mg in 40 mg žvečljive tablete in 10 mg, 20 mg, 40 mg in 80 mg filmsko obložene tablete.
English: OTHER SPECIAL WARNING(S), IF NECESSARY [To be completed nationally].
Slovenian: DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA [Izpolni država članica].
English: Common: Alanine aminotransferase increased, blood creatine phosphokinase increased Based on the data available, frequency, type and severity of adverse reactions in children are expected to be the same as in adults.
Slovenian: Pogosti: zvišanje alanin-aminotransferaze, zvišanje kreatin-fosfokinaze v krvi Na podlagi razpoložljivih podatkov, pogostnosti, vrste in izrazitosti neželenih učinkov je mogoče pričakovati, da so ti enaki kot pri odraslih.
English: ANNEX III CONDITIONS OF THE MARKETING AUTHORISATION
Slovenian: DODATEK III POGOJI DOVOLJENJA ZA PROMET Z DRAVILOM
English: The mean percent decreases in lipid parameters were similar for both cohorts, regardless of whether subjects remained at their initial dose or doubled their initial dose.
Slovenian: Povprečno odstotno zmanjšanje vrednosti lipidov je bilo v obeh skupinah podobno, ne glede na to, ali so preiskovanci ohranili začetni odmerek ali so jim začetni odmerek podvojili.
English: s r.o., Stroupežnického 17, 150 00 Prague 5,
Slovenian: s r.o., Stroupežnického 17, 150 00 Prague 5, Czech Republic
English: The above mentioned interactions for adults and the warnings in section 4.4 should be taken into account for the paediatric population.
Slovenian: Za pediatrično populacijo je treba upoštevati zgoraj omenjena medsebojna delovanja pri odraslih ter opozorila in previdnostne ukrepe v poglavju 4.4.
English: This medicinal product is authorised in the Member States of the EEA under the following names: {To be completed nationally}.
Slovenian: Zdravilo je v državah članicah EGP pridobilo dovoljenje za promet z naslednjimi imeni: {Izpolni država članica}.
English: Patients with rare hereditary problems of galactose intolerance, Lapp lactose deficiency or glucosegalactose malabsorption should not take this medicine.
Slovenian: Bolniki z redko dedno intoleranco za galaktozo, laponsko obliko zmanjšane aktivnosti laktaze ali malabsorpcijo glukoze/galaktoze ne smejo jemati tega zdravila.
English: The Risk Management Plan should include the ongoing study A2581173 (3-year study of the safety and follow-up study of efficacy of atorvastatin treatment of children and adolescents aged 6 years to less than 18 years with heterozygous familial hypercholesterolaemia).
Slovenian: Načrt za obvladovanje tveganja mora vključevati študijo A2581173, ki še poteka (3 letna študija varnosti in nadaljevalna študija učinkovitosti atorvastatina pri otrocih in mladostnikih starih od 6 do manj kot 18 let s heterozigotno familiarno hiperholesterolemijo).
English: What {PRODUCT NAME} is and what it is used for 2.
Slovenian: Kaj je zdravilo X in za kaj ga uporabljamo 2.
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Slovenian: DODATEK I SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, POTI UPORABE ZDRAVILA IN IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH
English: 4.7 Effects on ability to drive and use machines {To be completed nationally}.
Slovenian: 4.7 Vpliv na sposobnost vožnje in upravljanja s stroji {Izpolni država članica}.
English: Each {PRODUCT NAME} 5 mg chewable tablet contains 0.625 mg aspartame.
Slovenian: Ena {(Lastniško) ime} 5 mg žvečljiva tableta vsebuje 0,625 mg aspartama.
English: Common: Headache
Slovenian: Pogosti: glavobol
English: Contains a source of phenylalanine.
Slovenian: Vsebuje vir fenilalanina.
English: May be harmful for people with phenylketonuria.
Slovenian: Lahko škoduje ljudem s fenilketonurijo.
English: Hypercholesterolaemia:
Slovenian: Hiperholesterolemija:
English: PHARMACEUTICAL FORM AND CONTENTS 30 chewable tablets
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA 30 žvečljivih tablet
English: {PRODUCT NAME} chewable tablet contains aspartame which is a source of phenylalanine.
Slovenian: Žvečljiva tableta {(Lastniško) ime} vsebuje aspartam, ki je vir fenilalanina.
English: • Restart the cycle of PSUR submission for Sortis and associated names as follows: o Six-monthly PSURs until two full years of experience with the paediatric indication in the EU has been gained o Yearly PSURs for the following two years o Thereafter submission at 3-yearly intervals The PSURs should focus on the use in the paediatric population.
Slovenian: • Ponovno začel vlagati redna posodobljena poročila o varnosti zdravila (PSUR) za zdravilo Sortis in povezanih imen, kot sledi: o Šest mesečna PSUR poročila, dokler nista doseženi dve polni leti izkušenj s pediatrično indikacijo v Evropski Uniji (EU) o Letni PSURi za dve sledeči leti o Potem jih je potrebno vlagati v presledkih 3 let PSUR poročila morajo imeti poudarek na uporabi pri pediatrični populaciji.
English: A compassionate use study in patients with severe hypercholesterolaemia (including homozygous hypercholesterolaemia) included 46 paediatric patients treated with atorvastatin titrated according to response (some subjects received 80 mg atorvastatin per day).
Slovenian: Študija sočutne uporabe pri bolnikih s hudo hiperholesterolemijo (vključno s homozigotno hiperholesterolemijo) je zajela 46 pediatričnih bolnikov, ki so prejemali atorvastatin v odmerku, prilagojenemu glede na odziv (nekateri preiskovanci so dobili 80 mg atorvastatina na dan).
English: The dosage of atorvastatin (once daily) was 10 mg for the first 4 weeks and up-titrated to 20 mg if the LDL-C level was >3.36 mmol/l.
Slovenian: Odmerek atorvastatina (enkrat na dan) je bil prve 4 tedne 10 mg, potem pa so ga povečali na 20 mg, če je bil holesterol LDL > 3,36 mmol/l.
English: 4.8 Undesirable effects
Slovenian: 4.8 Neželeni učinki {Izpolni država članica}.
English: AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTIONS OF THE LABELLING
Slovenian: DOPOLNILA, KI JIH JE POTREBNO VKLJUČITI V RELEVANTNA POGLAVJA OZNAČEVANJA
English: Important information about some of the ingredients of {PRODUCT NAME} If youhave 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: Experience in pediatrics is limited to a small number of patients (age 4 - 17 years) with severe dyslipidemias, such as homozygous familial hypercholesterolemia.
Slovenian: Izkušnje z uporabo pri otrocih so omejene na maloštevilne bolnike (stare od 4 do 17 let) s hudimi dislipidamijami, npr. s homozigotno familiarno hiperholesterolemijo.
English: Special populations {To be completed nationally}.
Slovenian: Posebne populacije {Izpolni država članica}.
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: The maximum dose of {PRODUCT NAME}is 80 mg once daily for adults and 20 mg once daily for children.
Slovenian: Največji odmerek je 80 mg zdravila X enkrat na dan za odrasle in 20 mg enkrat na dan za otroke.
English: For patients aged 10 years and above, the recommended starting dose of atorvastatin is 10 mg per day with titration up to 20 mg per day.
Slovenian: Za bolnike, stare 10 let ali več, je priporočeni začetni odmerek atorvastatina 10 mg na dan s prilagajanjem do 20 mg na dan.
English: Cohort A included 15 children, 6 to 12 years of age and at Tanner Stage 1.
Slovenian: Skupina A je vključevala 15 otrok, starih od 6 do 12 let in s stopnjo 1 po Tannerju.
English: Heterozygous Familial Hypercholesterolaemia in Paediatric Patients aged 6-17 years old
Slovenian: Heterozigotna familiarna hiperholesterolemija pri pediatričnih bolnikih, starih od 6 do 17 let
English: Heterozygous Familial Hypercholesterolaemia in Paediatric Patients aged 10-17 years old
Slovenian: Heterozigotna familiarna hiperholesterolemija pri pediatričnih bolnikih, starih od 10 do 17 let
English: The European Medicines Agency has waived the obligation to submit the results of studies with atorvastatin in children aged 0 to less than 6 years in the treatment of heterozygous hypercholesterolaemia and in children aged 0 to less than 18 years in the treatment of homozygous familial hypercholesterolaemia, combined (mixed) hypercholesterolaemia, primary hypercholesterolaemia and in the prevention of cardiovascular events (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je odstopila od zahteve po predložitvi rezultatov študij z atorvastatinom pri otrocih starih od 0 do manj kot 6 let za zdravljenje heterozigotne hiperholesterolemije ter pri otrocih starih od 0 do manj kot 18 let za zdravljenje homozigotne familiarne hiperholesterolemije, kombinirane (mešane) hiperholesterolemije, primarne hiperholesterolemije in preprečevanje kardiovaskularnih dogodkov (glejte poglavje 4.2 za informacije o pediatrični uporabi).
English: The blisters consist of a forming foil made of polyamide/aluminium foil/polyvinyl chloride and a backing made of aluminium foil/vinyl/acryl heat-seal coating.
Slovenian: Pretisni omoti so iz oblikovane folije, izdelane iz poliamida/aluminijaste folije/polivinilklorida, in podloge, izdelane iz aluminijaste folije/vinila/akrila za toplotno lepljenje.
English: 6.2 Incompatibilities {To be completed nationally}.
Slovenian: 6.2 Inkompatibilnosti {Izpolni država članica}.
English: This medicine has been prescribed for you.
Slovenian: - To zdravilo je bilo predpisano vam osebno in ga ne smete dajati drugim.
English: The usual starting dose of {PRODUCT NAME} is 10 mg once a day in adults and children aged 10 years or older.
Slovenian: Običajni začetni odmerek je 10 mg zdravila X enkrat na dan pri odraslih in otrocih starejših od 10 let.
English: 4.9 Overdose {To be completed nationally}.
Slovenian: 4.9 Preveliko odmerjanje {Izpolni država članica}.
English: These amendments to the SPC, labelling and package leaflet are valid at the time of the Commission Decision.
Slovenian: Ta dopolnila povzetka glavnih značilnosti zdravila, ovojnine in navodila za uporabo so veljavna ob času odločbe komisije.
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: An additional paediatric study of atorvastatin versus colestipol in patients with hypercholesterolaemia aged 10-18 years demonstrated that atorvastatin (N=25) caused a significant reduction in LDL-C at week 26 (p<0.05) compared with colestipol (N=31).
Slovenian: Dodatna pediatrična študija atorvastatina v primerjavi s holestipolom pri bolnikih s hiperholesterolemijo, starih od 10 do 18 let, je pokazala, da je atorvastatin (n = 25) po 26 tednih povzročil pomembno znižanje vrednosti holesterola LDL (p < 0,05) v primerjavi s holestipolom (n = 31).
English: Do not use {PRODUCT NAME} after the expiry date {EXP:} which is stated on the blister container and outer packaging.
Slovenian: Zdravila X ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na ovojninipretisnem omotu.
English: ANNEX II AMENDMENTS TO THE SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
Slovenian: DODATEK II DOPOLNILA POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA, OVOJNINE IN NAVODILA ZA UPORABO
English: {PRODUCT NAME} tablets also contain the inactive ingredients: calcium carbonate, microcrystalline cellulose, croscarmellose sodium, polysorbate 80, hydroxypropyl cellulose, amylum pregelificatum, mannitol, aspartame, sucralose, grape flavour and magnesium stearate.
Slovenian: Pomožne snovi so: kalcijev karbonat, mikrokristalna celuloza, premreženi natrijev karmelozat polisorbat 80, hidroksipropilceluloza, predgelirani škrob, manitol, aspartam, sukraloza, grozdna aroma in magnezijev stearat.
English: Hypercholesterolaemia {PRODUCT NAME} is indicated as an adjunct to diet for reduction of elevated total cholesterol, LDL-cholesterol, apolipoprotein B, and triglycerides in patients adults, adolescents and children aged 10 years or older with primary hypercholesterolaemia including familial hypercholesterolaemia (heterozygous variant) or combined (mixed) hyperlipidaemia (Corresponding to Types IIa and IIb of the Fredrickson classification) when response to diet and other nonpharmacological measures is inadequate.
Slovenian: Zdravilo {(Lastniško) ime} je indicirano kot dodatek k dieti za znižanje zvišanega celotnega holesterola, holesterola LDL, apolipoproteina B in trigliceridov pri bolnikih odraslih, mladostnikih in otrocih starejših od 10 let s primarno hiperholesterolemijo, vključno s familiarno hiperholesterolemijo (heterozigotna oblika) ali kombinirano (mešano) hiperlipidemijo (kar ustreza tipoma IIa in IIb po Fredricksonovi klasifikaciji), kadar odziv na dieto in druge nefarmakološke ukrepe ni zadosten.
English: {PRODUCT NAME} is also indicated to reduce total-C and LDL-C in patients adults with homozygous familial hypercholesterolaemia as an adjunct to other lipid-lowering treatments (e.g. LDL apheresis) or if such treatments are unavailable.
Slovenian: Zdravilo {(Lastniško) ime} je indicirano tudi za znižanje zvišanega celotnega holesterola in holesterola LDL pri bolnikih odraslih s homozigotno obliko familiarne hiperholesterolemije kot dodatek drugim načinom terapevtskega zniževanja lipidov (npr. aferezi LDL) ali če takšni načini niso na voljo.
English: AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTIONS OF THE SUMMARY OF PRODUCT CHARACTERISTICS
Slovenian: DOPOLNILA, KI JIH JE POTREBNO VKLJUČITI V RELEVANTNA POGLAVJA POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA
English: Titration should be conducted according to the individual response and tolerability in paediatric patients.
Slovenian: Prilagajanje je treba pri pediatričnih bolnikih opraviti v skladu s posameznikovim odzivom in prenašanjem.
English: POSSIBLE SIDE EFFECTS {To be completed nationally}.
Slovenian: MOŽNI NEŽELENI UČINKI {Izpolni država članica}.
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 filmcoated 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} looks like and contents of the pack {PRODUCT NAME} 5 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} 5 mg žvečljive tablete so bele do umazano bele, okrogle žvečljive tablete z rožnatimi do vijoličastimi lisami.
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.}> <{fax}>
English: {To be completed nationally}.
Slovenian: {Izpolni država članica}.
English: Apparent oral clearance of atorvastatin in paediatric subjects appeared similar to adults when scaled allometrically by body weight.
Slovenian: Na telesno maso alometrično preračunani navidezni peroralni očistek atorvastatina je bil pri pediatričnih preiskovancih podoben kot pri odraslih.
English: 4.6 Pregnancy and lactation {To be completed nationally}.
Slovenian: 4.6 Nosečnost in dojenje {Izpolni država članica}.
English: Possible side effects
Slovenian: Možni neželeni učinki 5.
English: Marketing Authorisation Holder and Manufacturer {Name and address} <{tel}> <{fax}> <{e-mail}> [See Annex I - To be completed nationally]
Slovenian: Imetnik dovoljenja za promet z zdravilom in izdelovalec {Ime in naslov} <{tel.}> <{fax}> <{e-mail}> [Glejte Dodatek I - Izpolni država članica]
English: 6.6 Special precautions for disposal {To be completed nationally}.
Slovenian: 6.6 Posebni varnostni ukrepi za odstranjevanje {Izpolni država članica}.
English: The active substance of {PRODUCT NAME} is atorvastatin.
Slovenian: Zdravilna učinkovina je atorvastatin.
English: Paediatric: Pharmacokinetic data in the paediatric population are not available.
Slovenian: Otroci: Farmakokinetičnih podatkov za otroke ni.
English: {PRODUCT NAME} tablets can be chewed or swallowed whole with a drink of water, and can be taken at any time of day, with or without food.
Slovenian: Vzeti jih je mogoče ob kateremkoli času dneva, s hrano ali brez nje.
English: They are marked with 5 on one side and Pfizer on the other side.
Slovenian: Tablete imajo na eni strani vtisnjeno oznako "5" in na drugi "Pfizer".
English: INFORMATION IN BRAILLE {PRODUCT NAME} 5 mg chewable tablets
Slovenian: PODATKI V BRAILLOVI PISAVI {(Lastniško) ime} 5 mg žvečljive tablete
English: Body weight was the only significant covariate in atorvastatin population PK model.
Slovenian: V modelu populacijske farmakokinetike atorvastatina je bila edina statistično pomembna sospremenljivka telesna masa.
English: The clinical safety database includes safety data for 249 paediatric patients who received atorvastatin, among which 7 patients were < 6 years old, 14 patients were in the age range of 6 to 9, and 228 patients were in the age range of 10 to 17.
Slovenian: Od tega je bilo 7 bolnikov mlajših od 6 let, 14 bolnikov je bilo starih od 6 do 9 let in 228 bolnikov od 10 do 17 let.
English: At Week 8, on average, the percent change from baseline in LDL-C and TC was approximately 40% and 30%, respectively, over the range of exposures.
Slovenian: V celotnem razponu izpostavljenosti je bila v povprečju po 8 tednih odstotna sprememba od izhodiščnega LDL 40 % in trigliceridov 30 %.
English: Chewable tablet
Slovenian: Žvečljiva tableta
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each chewable tablet contains 5 mg atorvastatin (as atorvastatin calcium (trihydrate)).
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena žvečljiva tableta vsebuje 5 mg atorvastatina (v obliki kalcijevega atorvastatinata trihidrata).
English: 4.4 Special warnings and precautions for use {To be completed nationally}.
Slovenian: 4.4 Posebna opozorila in previdnostni ukrepi {Izpolni država članica}.
English: White to off-white, round chewable tablets with pink to purple specks, debossed "5" on one side and “Pfizer” on the other measuring 5.6 mm in diameter.
Slovenian: Tablete imajo na eni strani vtisnjeno oznako "5" in na drugi "Pfizer" ter v premeru merijo 5,6 mm.