FrancophonIA/ELRC3.0 huggingface dataset:
English: Felodipine has anti-anginal and anti-ischaemic effects due to improved myocardial oxygen supply/demand balance.
Slovenian: Felodipin deluje antianginozno in antiishemično, ker izboljša ravnovesje med oskrbo in potrebo miokarda po kisiku.
English: • Itraconazole
Slovenian: • itrakonazol
English: This medicine can be taken without food or following a light meal not high in fat or carbohydrates.
Slovenian: Zdravilo lahko vzamete na prazen želodec ali po lahkem obroku, ki ne vsebuje veliko maščob ali ogljikovih hidratov.
English: • rifampicin (medicine to treat infections)
Slovenian: • rifampicin (zdravilo za zdravljenje okužb)
English: [To be completed nationally] [See Annex I - To be completed nationally]
Slovenian: [Izpolni država članica] [Glejte Prilogo I - Izpolni država članica]
English: Coronary vascular resistance is decreased and coronary blood flow and myocardial oxygen supply are increased by felodipine due to dilatation of both epicardial arteries and arterioles.
Slovenian: Felodipin zmanjša upor koronarnih žil in poveča koronarni pretok krvi in oskrbo miokarda s kisikom, ker povzroči dilatacijo epikardialnih arterij in arteriol.
English: Because there is no effect on venous smooth muscle or adrenergic vasomotor control, felodipine is not associated with orthostatic hypotension.
Slovenian: Felodipin ne vpliva na vensko gladko mišičje ali na adrenergično vazomotorično kontrolo, zato ga ne spremlja ortostatska hipotenzija.
English: Very rare
Slovenian: Manj kot
English: Uncommon Tachycardia, palpitations
Slovenian: Srčne bolezni občasni tahikardija, palpitacije
English: Felodipine has been detected in breast milk, and due to insufficient data on potential effect on the infant, treatment is not recommended during breastfeeding.
Slovenian: Zaradi nezadostnih podatkov o možnem vplivu na dojenčka zdravljenje s felodipinom med obdobjem dojenja ni priporočljivo.
English: Treatment can be started with 5 mg once daily.
Slovenian: Zdravljenje je mogoče začeti z odmerkom 5 mg enkrat na dan.
English: Each tablet contains 2.5 mg 5 mg or 10 mg of felodipine.
Slovenian: Ena tableta vsebuje 2,5 mg 5 mg ali 10 mg felodipina.
English: Do not take Plendil if you are pregnant.
Slovenian: - če ste noseči.
English: The tablets can be administered without food or following a light meal not rich in fat or carbohydrate.
Slovenian: Vzeti jih je mogoče na prazen želodec ali po lahkem obroku, ki ni bogat z maščobami in ogljikovimi hidrati.
English: If you have any bothersome or unusual reaction while taking Plendil, check with your doctor right away.
Slovenian: Če se vam med jemanjem zdravila Plendil pojavijo moteči ali nenavadni učinki, se takoj posvetujte z zdravnikom.
English: 1 blister of 28 tablets 2 blisters of 14 tablets 4 blisters of 7 tablets
Slovenian: 1 pretisni omot, ki vsebuje 28 tablet 2 pretisna omota, ki vsebujeta po 14 tablet 4 pretisni omoti, ki vsebujejo po 7 tablet
English: Cimetidine increased the felodipine Cmax and AUC by approximately 55%.
Slovenian: Cimetidin je povečal Cmax in AUC
English: Felodipine is cleared by the liver.
Slovenian: Felodipin se odstranjuje v jetrih.
English: Concomitant administration of substances which interfere with CYP3A4 enzyme system may affect plasma concentrations of felodipine.
Slovenian: Sočasna uporaba snovi, ki vplivajo na encimski sistem CYP3A4, lahko vpliva na koncentracijo felodipina v plazmi.
English: In a nonclinical reproductive study in the rat (see section 5.3), there were effects on fetal development but no effect on fertility at doses approximating to therapeutic.
Slovenian: V predklinični študiji vpliva na sposobnost razmnoževanja pri podganah (glejte poglavje 5.3) so ob odmerkih, ki so bili blizu terapevtskih,
English: • Carbamazepine
Slovenian: • karbamazepin
English: Pack sizes of 20, 28, 30, 98 and 100 tablets
Slovenian: Velikosti pakiranj z 20, 28, 30, 98 in 100 tabletami
English: • erythromycin (medicine to treat infections)
Slovenian: • eritromicin (zdravilo za zdravljenje okužb)
English: If you forget to take a tablet, leave out that dose completely.
Slovenian: Naj vas to ne skrbi: če ste pozabili vzeti tableto, pozabljeni odmerek preprosto izpustite, naslednji odmerek pa vzemite ob pravem času.
English: Felodipine can be used as monotherapy or in combination with ß-adrenoceptor blockers in patients with stable angina pectoris.
Slovenian: Felodipin je mogoče pri bolnikih s stabilno angino pektoris uporabiti kot samostojno zdravljenje (monoterapijo) ali v kombinaciji z blokatorjem adrenergičnih receptorjev ß.
English: Felodipine has minor or moderate influence on the ability to drive and use machines.
Slovenian: 4.7 Vpliv na sposobnost vožnje in upravljanja s stroji Felodipin ima lahko blag ali zmeren vpliv na sposobnost vožnje in upravljanja s stroji.
English: Treatment should be started with 5 mg once a day.
Slovenian: Zdravljenje je treba začeti z odmerkom 5 mg enkrat na dan.
English: In case of lack of efficacy due to decreased felodipine exposure when combined with potent inducers of CYP3A4, adjustment of felodipine dose and/or discontinuation of the CYP3A4 inducer should be considered.
Slovenian: Če se zaradi sočasne uporabe močnih induktorjev CYP3A4 pojavi nezadostna učinkovitost zaradi zmanjšane izpostavljenosti felodipinu, pride v poštev prilagoditev odmerka felodipina in/ali prenehanje uporabe induktorja CYP3A4.
English: • carbamazepine (medicine to treat epilepsy)
Slovenian: • karbamazepin (zdravilo za zdravljenje epilepsije)
English: In non-clinical reproductive toxicity studies there were foetal developmental effects, which are considered to be due to the pharmacological action of felodipine.
Slovenian: V predkliničnih študijah vpliva na sposobnost razmnoževanja so ugotavljali razvojne učinke na plod, ki jih pripisujejo farmakološkemu delovanju felodipina.
English: • Anti HIV/protease inhibitors (e.g. ritonavir)
Slovenian: • zaviralci proteaz proti HIV (npr. ritonavir)
English: Mild gingival enlargement has been reported in patients with pronounced gingivitis/periodontitis.
Slovenian: Pri bolnikih z izrazitim gingivitisom/periodontitisom je bilo opisano blago povečanje dlesni.
English: Treatment should be initiated with 5 mg once daily and, if needed, increased to 10 mg once daily.
Slovenian: Zdravljenje je treba začeti s 5 mg enkrat na dan in odmerek povečati na 10 mg enkrat na dan, če je treba.
English: Each tablet contains 10 mg felodipine.
Slovenian: Ena tableta vsebuje 10 mg felodipina.
English: Do not use Plendil if you are pregnant.
Slovenian: Če ste noseči, ne uporabljajte zdravila Plendil.
English: 1 bottle of 100 tablets 10 blisters of 10 tablets Not all pack sizes may be marketed.
Slovenian: 10 pretisnih omotov, ki vsebujejo po 10 tablet Na trgu morda ni vseh navedenih pakiranj.
English: However, there have been no reported clinical incidences of phalangeal changes in foetus/neonate exposed to felodipine in-utero, from the information maintained within the internal patient safety databases.
Slovenian: zajetih v internih podatkovnih bazah o varnosti za bolnike, ni bilo primerov kliničnega pojava sprememb na falangah pri plodovih/novorojenčkih, ki so bili in utero izpostavljeni felodipinu.
English: Carnauba wax Iron oxide yellow (E172) Hypromellose 6 mPa·s Macrogol 6000
Slovenian: Obloga karnauba vosek rumeni železov oksid (E172) hipromeloza 6 mPa·s makrogol 6000 titanov dioksid (E171)
English: The rate but not the extent of absorption of felodipine is increased when taken simultaneously with food with a high fat content.
Slovenian: Če je felodipin uporabljen hkrati z mastno hrano, se poveča hitrost, ne pa obseg njegove absorpcije.
English: Each tablet contains 5 mg felodipine.
Slovenian: Ena tableta vsebuje 5 mg felodipina.
English: There were no other pre clinical findings considered to be of concern and the reproductive findings are considered to be related to the pharmacological action of felodipine, when given to normotensive animals.
Slovenian: Vplive na sposobnost razmnoževanja so ocenili kot povezane s farmakološkim delovanjem felodipina, uporabljenega pri normotenzivnih živalih.
English: Taking Plendil may cause your gums to become swollen.
Slovenian: Jemanje zdravila Plendil lahko povzroči oteklost dlesni.
English: Pack sizes of 14, 20, 28, 30, 90, 98 and 100 tablets
Slovenian: Velikosti pakiranj s 14, 20, 28, 30, 90, 98 in 100 tabletami Velikosti pakiranj s 14, 20, 28, 30, 98 in 100 tabletami
English: Interactions leading to decreased plasma concentration of felodipine Enzyme inducers of the cytochrome P450 3A4 system have been shown to cause a decrease in plasma concentrations of felodipine.
Slovenian: Medsebojna delovanja, ki zmanjšajo koncentracijo felodipina v plazmi Ugotovljeno je, da induktorji encimov sistema 3A4 citokroma P450 zmanjšajo koncentracijo felodipina v plazmi.
English: Photosensitivity reactions, leucocytoclastic vasculitis
Slovenian: levkocitoklastični vaskulitis
English: • A need to pass water frequently
Slovenian: • vnetje malih žil v koži • potreba po pogostem odvajanju urina
English: Impotence/sexual dysfunction
Slovenian: Motnje reprodukcije in dojk redki impotenca/motnja spolnega delovanja
English: Sympathomimetic medicinal products with predominant effect on the α1-adrenoceptor may be given if the above-mentioned measures are insufficient.
Slovenian: Če našteti ukrepi ne zadoščajo, je mogoče uporabiti simpatikomimetična zdravila, ki delujejo pretežno na adrenergične receptorje α1.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 2.5 mg (or 5 mg, or 10 mg) felodipine
Slovenian: Ena tableta vsebuje 2,5 mg (ali 5 mg ali 10 mg) felodipina.
English: In case of clinically significant adverse events due to elevated felodipine exposure when combined with strong CYP3A4 inhibitors, adjustment of felodipine dose and/or discontinuation of the CYP3A4 inhibitor should be considered.
Slovenian: Če se zaradi sočasne uporabe močnih zaviralcev CYP3A4 pojavijo klinično pomembni neželeni učinki, ki so posledica večje izpostavljenosti felodipinu, pride v poštev prilagoditev odmerka felodipina in/ali prenehanje uporabe zaviralca CYP3A4.
English: 1 blister of 14 tablets
Slovenian: 1 pretisni omot, ki vsebuje 14 tablet
English: Plendil contains the active substance felodipine.
Slovenian: Zdravilo Plendil vsebuje zdravilno učinkovino felodipin.
English: - The active substance felodipine.
Slovenian: - Zdravilna učinkovina je felodipin.
English: 3 blisters of 10 tablets 1 bottle of 30 tablets
Slovenian: 3 pretisni omoti, ki vsebujejo po 10 tablet 1 plastenka s 30 tabletami
English: • itraconazole (medicine to treat fungi)
Slovenian: • itrakonazol (zdravilo za zdravljenje glivic)
English: Interactions leading to increased plasma concentration of felodipine CYP3A4 enzyme inhibitors have been shown to cause an increase in felodipine plasma concentrations.
Slovenian: Medsebojna delovanja, ki povečajo koncentracijo felodipina v plazmi Ugotovljeno je, da zaviralci encimov CYP3A4 povečajo koncentracijo felodipina v plazmi.
English: • Phenytoin
Slovenian: • fenitoin
English: 14 tablets 20 tablets 28 tablets 30 tablets 90 tablets 98 tablets 100 tablets
Slovenian: 14 tablet 20 tablet 28 tablet 30 tablet 90 tablet 98 tablet 100 tablet
English: • ketoconazole (medicine to treat fungi)
Slovenian: • ketokonazol (zdravilo za zdravljenje glivic)
English: <[To be completed nationally]>
Slovenian: <[Izpolni država članica.
English: felodipine
Slovenian: felodipin
English: 4 blisters of 7 tablets
Slovenian: 4 pretisni omoti, ki vsebujejo po 7 tablet
English: No disturbances of fertility were observed when doses within the therapeutic range were given to rats.
Slovenian: Če so podganam dajali odmerke, ki so bili v terapevtskem razponu, niso opažali motenj plodnosti.
English: • Burning/prickling/numbness
Slovenian: • pekoč občutek/mravljinčenje/omrtvičenost
English: 1 bottle of 30 tablets 3 blisters of 10 tablets
Slovenian: 1 plastenka s 30 tabletami 3 pretisni omoti, ki vsebujeja po 10 tablet
English: Plendil 2.5 mg prolonged-release tablet is yellow, circular, biconvex, engraved A/FL on one side and 2.5 on the other side, with a diameter of 8.5 mm.
Slovenian: Zdravilo Plendil 2,5 mg tableta s podaljšanim sproščanjem je rumena, okrogla, na obeh straneh izbočena (bikonveksna) tableta s premerom 8,5 mm, ki ima na eni strani vtisnjeno oznako A/FL in na drugi strani 2,5.
English: Iron oxide reddish-brown (E172) (Only used for Plendil 5 mg and 10 mg) Iron oxide yellow (E172)
Slovenian: Obloga tablete: karnauba vosek rdečkasto-rjavi železov oksid(E172) (uporabljen le v tabletah Plendil 5 mg in 10 mg) rumeni železov oksid (E172) hipromeloza 6 mPa·s makrogol 6000 titanov dioksid (E171)
English: 20 tablets 28 tablets 30 tablets 98 tablets 100 tablets
Slovenian: 20 tablet 28 tablet 30 tablet 98 tablet 100 tablet
English: Mild enlargement of the gums has been reported in patients with an inflammation in the mouth (gingivitis/periodontitis).
Slovenian: Pri bolnikih, ki so imeli v ustih vnetje (gingivitis/periodontitis), je bilo opisano blago povečanje dlesni.
English: Plendil is used in the treatment of high blood pressure (hypertension) and heart and chest pain brought on by for example exercise or stress (angina pectoris).
Slovenian: ki jih povzročita na primer telesna dejavnost ali stres (angina pektoris).
English: • phenytoin (medicine to treat epilepsy)
Slovenian: • fenitoin (zdravilo za zdravljenje epilepsije)
English: 2 blisters of 10 tablets
Slovenian: 2 pretisna omota, ki vsebujeta po 10 tablet
English: Each tablet contains 28 mg lactose and 10 mg polyoxyl 40 hydrogenated castor oil.
Slovenian: Ena tableta vsebuje 28 mg laktoze in 10 mg makrogolglicerol hidroksistearata 40.
English: Musculoskeletal and connective tissue disorders
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva redki artralgija, mialgija
English: Haemodynamic effects
Slovenian: Hemodinamski učinki
English: 1 bottle of 100 tablets 10 blisters of 10 tablets
Slovenian: 1 plastenka s 100 tabletami 10 pretisnih omotov, ki vsebujejo po 10 tablet
English: 14 tablets 20 tablets 28 tablets 30 tablets 98 tablets 100 tablets
Slovenian: 14 tablet 20 tablet 28 tablet 30 tablet 98 tablet 100 tablet
English: 7 blisters of 14 tablets
Slovenian: 7 pretisnih omotov, ki vsebujejo po 14 tablet
English: MARKETING AUTHORISATION NUMBER(S) [To be completed nationally]
Slovenian: ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET
English: Iron oxide reddish-brown (E172) Iron oxide yellow (E172) Hypromellose 6 mPa·s Macrogol 6000
Slovenian: [Plendil 5 mg in 10 mg] karnauba vosek rdečkasto-rjavi železov oksid (E172) rumeni železov oksid (E172) hipromeloza 6 mPa·s makrogol 6000 titanov dioksid (E171)
English: Plendil 5 mg prolonged-release tablet is pink, circular, biconvex, engraved A/Fm on one side and 5 on the other side, with a diameter of 9 mm.
Slovenian: Zdravilo Plendil 5 mg tableta s podaljšanim sproščanjem je rožnata, okrogla, na obeh straneh izbočena (bikonveksna) tableta s premerom 9 mm, ki ima na eni strani vtisnjeno oznako A/Fm in na drugi strani 5.
English: Hypotension Syncope
Slovenian: Odmerjanje Hipertenzija
English: Plendil 10 mg prolonged-release tablet is reddish-brown, circular, biconvex, engraved A/FE on one side and 10 on the other side, with a diameter of 9.
Slovenian: Zdravilo Plendil 10 mg tableta s podaljšanim sproščanjem je rdečkasto-rjava, okrogla, na obeh straneh izbočena (bikonveksna) tableta s premerom 9 mm, ki ima na eni strani vtisnjeno oznako A/FE in na drugi strani 10.
English: Each tablet contains 28 mg lactose and 2.5 mg polyoxyl 40 hydrogenated castor oil.
Slovenian: Ena tableta vsebuje 28 mg laktoze in 2,5 mg makrogolglicerol hidroksistearata 40.
English: The tablet is yellow, circular, biconvex, engraved A/FL on one side and 2.5 on the other side, with a diameter of 8.5 mm.
Slovenian: Rumena, okrogla, bikonveksna tableta s premerom 8,5 mm, ki ima na eni strani vtisnjeno oznako A/FL in na drugi strani 2,5.
English: Each tablet contains 28 mg lactose and 5 mg polyoxyl 40 hydrogenated castor oil.
Slovenian: Ena tableta vsebuje 28 mg laktoze in 5 mg makrogolglicerol hidroksistearata 40.
English: Enzyme inhibiting and enzyme inducing substances of cytochrome P450 isoenzyme 3A4 may exert an influence on the plasma level of felodipine.
Slovenian: Snovi, ki zavrejo ali inducirajo izoencime 3A4 citokroma P450, lahko vplivajo na koncentracijo felodipina v plazmi.
English: Renal impairment Dose adjustment is not needed in patients with impaired renal function.
Slovenian: Okvara ledvic Bolnikom z okvarjenim delovanjem ledvic odmerka ni treba prilagoditi.
English: Concomitant administration of drugs that strongly induce or inhibit CYP3 A4 enzymes result in extensively decreased or increased plasma levels of felodipine, respectively.
Slovenian: Sočasna uporaba zdravil, ki močno inducirajo ali zavirajo encime CYP3 A4, povzroči precejšnje znižanje oziroma zvišanje koncentracije felodipina v plazmi, zato se je uporabi takih kombinacij treba izogniti (glejte poglavje 4.5).
English: Felodipine has a natriuretic and diuretic effect due to reduced tubular reabsorption of filtered sodium.
Slovenian: Zaradi zmanjšane tubularne reabsorpcije filtriranega natrija deluje felodipin natriuretično in diuretično.
English: • cimetidine (medicine to treat gastric ulcers)
Slovenian: • cimetidin (zdravilo za zdravljenje razjed na želodcu)
English: Cardiac effects
Slovenian: Učinki na ledvice
English: 3 blisters of 30 tablets
Slovenian: 3 pretisni omoti, ki vsebujejo po 30 tablet
English: Felodipine may cause significant hypotension with subsequent tachycardia.
Slovenian: Felodipin lahko povzroči pomembno hipotenzijo in posledično tahikardijo; dovzetnim bolnikom se lahko zaradi tega pojavi ishemija miokarda.
English: Pollakisuria
Slovenian: Dojenje
English: Contents of the pack and other information
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Plendil
English: Gingival hyperplasia, gingivitis
Slovenian: Bolezni prebavil občasni redki zelo redki navzea, bolečine v trebuhu bruhanje hiperplazija dlesni, gingivitis
English: Dose-dependent ankle swelling can occur in patients treated with felodipine.
Slovenian: Bolnikom, ki jemljejo felodipin, se lahko pojavi od odmerka odvisno otekanje gležnjev.
English: The tablet is pink, circular, biconvex, engraved A/Fm on one side and 5 on the other side, with a diameter of 9 mm.
Slovenian: Rožnata, okrogla, bikonveksna tableta s premerom 9 mm, ki ima na eni strani vtisnjeno oznako A/Fm in na drugi strani 5.
English: The pharmacokinetics of felodipine is not changed in patients with renal impairment, including those treated with haemodialysis.
Slovenian: Farmakokinetika felodipina pri bolnikih z okvaro ledvic
English: The tablet is reddish-brown, circular, biconvex, engraved A/FE on one side and 10 on the other side, with a diameter of 9 mm.
Slovenian: Rdečkasto-rjava, okrogla, bikonveksna tableta s premerom 9 mm, ki ima na eni strani vtisnjeno oznako A/FE in na drugi strani 10.
English: Uncommon: may affect up to 1 in 100 people
Slovenian: • vročinski oblivi Občasni: pojavijo se lahko pri največ 1 od 100 bolnikov
English: • Muscular pain
Slovenian: • bolečine v trebuhu
English: You should tell your doctor as soon as possible if you become pregnant while using this medicine.
Slovenian: Če med uporabo tega zdravila zanosite, morate to čim prej povedati zdravniku.
English: 10 blisters of 10 tablets
Slovenian: 10 pretisnih omotov, ki vsebujejo po 10 tablet
English: Very rare: may affect up to 1 in 10,000 people
Slovenian: • impotenca/motnja spolnega delovanja Zelo redki: pojavijo se lahko pri največ 1 od 10.000 bolnikov
English: • Pregnancy
Slovenian: • nosečnost
English: High-density polyethylene bottle with a cap of polypropylene PVC/PVDC blister and Aluminum blister
Slovenian: PVC/PVDC pretisni omot in aluminijski pretisni omot.
English: Felodipine Cmax and AUC increased 8-fold and 6-fold, respectively, when felodipine was coadministered with the strong CYP3A4 inhibitor itraconazole.
Slovenian: Če je bil felodipin uporabljen sočasno z močnim zaviralcem CYP3A4 itrakonazolom, se je Cmax felodipina povečala za 8-krat in njegova AUC za 6-krat.
English: Plendil is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed.
Slovenian: Zdravilo Plendil ni priporočljivo za matere, ki dojijo.
English: CLINICAL PARTICULARS 4.1 Therapeutic indications Hypertension
Slovenian: 4.1 Terapevtske indikacije hipertenzija stabilna angina pektoris.
English: PACKAGE LEAFLET
Slovenian: Velikost pakiranja
English: LIST OF EXCIPIENTS Contains lactose and polyoxyl 40 hydrogenated castor oil.
Slovenian: Vsebuje laktozo in makrogolglicerol hidroksistearat 40.
English: The renal vascular resistance is decreased by felodipine.
Slovenian: Felodipin zmanjša upor ledvičnih žil.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 2.5 mg felodipine.
Slovenian: Ena tableta vsebuje 2,5 mg felodipina.
English: Tablet core:
Slovenian: Preglednica 1.
English: • Pain in joints
Slovenian: • otekanje gležnjev
English: Nausea, abdominal pain Vomiting
Slovenian: Bolezni živčevja pogosti občasni glavobol omotica, parestezije
English: Results are presented above.
Slovenian: Rezultati so predstavljeni zgoraj.
English: The frequency of these two side effects is not known.
Slovenian: Pogostnost teh dveh neželenih učinkov ni znana.
English: Stabilization of the symptoms had to be obtained before the end of the first 14 days of each treatment period.
Slovenian: Stabilizacijo simptomov je bilo treba doseči pred koncem prvih 14 dni vsakega obdobja zdravljenja.
English: Opening date :
Slovenian: Datum odprtja:
English: Moreover three supportive studies were conducted in 34 paediatric patients.
Slovenian: Poleg tega so opravili tri podporne študije pri 34 pediatričnih bolnikih.
English: Patients should be instructed not to increase the dosage on their own.
Slovenian: Bolnikom je treba naročiti, naj ne povečujejo odmerka sami.
English: Difference in LS means (95% confidence limits)
Slovenian: Razlika v povprečnih NK (95 % meje zaupanja)
English: Approximately half of the patients were ages 1 to 3 years.
Slovenian: Približno pol bolnikov je bilo starih od 1 do 3 let.
English: No clinically relevant interactions are expected.
Slovenian: Klinično pomembnih interakcij ni pričakovati.
English: N: number of patients; SD: standard deviation; LS: least squares.
Slovenian: N: število bolnikov; SD: standardna deviacija; NK: najmanjši kvadrati.
English: If your doctor advises you to increase the number of capsules you take each day, you should do so slowly over several days.
Slovenian: Če vam zdravnik svetuje povečanje števila kapsul, ki jih jemljete vsak dan, morate to narediti počasi, v roku nekaj dni.
English: Twelve patients completed the study.
Slovenian: Študijo je zaključilo dvanajst bolnikov.
English: Keep taking your medicine until your doctor tells you to stop.
Slovenian: Zdravilo jemljite, dokler vam zdravnik ne naroči, da prenehajte.
English: Other reported clinical experience has not identified differences in responses between the elderly and young patients.
Slovenian: Druge klinične izkušnje, o katerih so poročali, ne kažejo na razlike v odzivu med starejšimi in mlajšimi bolniki.
English: Wait until your next meal, and take your usual number of capsules with your meal.
Slovenian: Počakajte do naslednjega obroka in ob obroku vzemite običajno število kapsul.
English: You may also sprinkle the granules directly into your child's mouth.
Slovenian: Zrnca lahko stresete tudi neposredno v otrokova usta.
English: Very common (may affect more than 1 in 10 people): stomach pain.
Slovenian: Zelo pogosti (lahko se pojavijo pri več kot 1 od 10 oseb): bolečine v trebuhu.
English: Variable statistic
Slovenian: Statistika spremenljivk
English: The primary objective was to assess the acceptability of 2 modes of administration using an acceptability questionnaire that was completed by the caregiver.
Slovenian: Primarni cilj je bil oceniti sprejemljivost 2 načinov dajanja z vprašalnikom o sprejemljivosti, ki ga je izpolnil negovalec.
English: Overall, caregivers were satisfied with using apple sauce as a dosing method compared with apple juice.
Slovenian: Na splošno so bili negovalci bolj zadovoljni z uporabo jabolčne čežane kot načina odmerjanja v primerjavi z jabolčnim sokom.