natgillin/translations-raw huggingface dataset:
Treatment should be initiated with 5 mg once daily and, if needed, increased to 10 mg once daily. 
Zdravljenje je treba začeti s 5 mg enkrat na dan in odmerek povečati na 10 mg enkrat na dan, če je treba.
Each tablet contains 10 mg felodipine. 
Ena tableta vsebuje 10 mg felodipina.
Do not use Plendil if you are pregnant. 
Če ste noseči, ne uporabljajte zdravila Plendil.
1 bottle of 100 tablets 10 blisters of 10 tablets Not all pack sizes may be marketed. 
10 pretisnih omotov, ki vsebujejo po 10 tablet Na trgu morda ni vseh navedenih pakiranj.
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. 
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.
Carnauba wax Iron oxide yellow (E172) Hypromellose 6 mPa·s Macrogol 6000 
Obloga karnauba vosek rumeni železov oksid (E172) hipromeloza 6 mPa·s makrogol 6000 titanov dioksid (E171)
The rate but not the extent of absorption of felodipine is increased when taken simultaneously with food with a high fat content. 
Če je felodipin uporabljen hkrati z mastno hrano, se poveča hitrost, ne pa obseg njegove absorpcije.
Each tablet contains 5 mg felodipine. 
Ena tableta vsebuje 5 mg felodipina.
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. 
Vplive na sposobnost razmnoževanja so ocenili kot povezane s farmakološkim delovanjem felodipina, uporabljenega pri normotenzivnih živalih.
Taking Plendil may cause your gums to become swollen. 
Jemanje zdravila Plendil lahko povzroči oteklost dlesni.
Pack sizes of 14, 20, 28, 30, 90, 98 and 100 tablets 
Velikosti pakiranj s 14, 20, 28, 30, 90, 98 in 100 tabletami Velikosti pakiranj s 14, 20, 28, 30, 98 in 100 tabletami
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. 
Medsebojna delovanja, ki zmanjšajo koncentracijo felodipina v plazmi Ugotovljeno je, da induktorji encimov sistema 3A4 citokroma P450 zmanjšajo koncentracijo felodipina v plazmi.
Photosensitivity reactions, leucocytoclastic vasculitis 
levkocitoklastični vaskulitis
• A need to pass water frequently 
• vnetje malih žil v koži • potreba po pogostem odvajanju urina
Impotence/sexual dysfunction 
Motnje reprodukcije in dojk redki impotenca/motnja spolnega delovanja
Sympathomimetic medicinal products with predominant effect on the α1-adrenoceptor may be given if the above-mentioned measures are insufficient. 
Če našteti ukrepi ne zadoščajo, je mogoče uporabiti simpatikomimetična zdravila, ki delujejo pretežno na adrenergične receptorje α1.
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 2.5 mg (or 5 mg, or 10 mg) felodipine 
Ena tableta vsebuje 2,5 mg (ali 5 mg ali 10 mg) felodipina.
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. 
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.
1 blister of 14 tablets 
1 pretisni omot, ki vsebuje 14 tablet
Plendil contains the active substance felodipine. 
Zdravilo Plendil vsebuje zdravilno učinkovino felodipin.
- The active substance felodipine. 
- Zdravilna učinkovina je felodipin.
3 blisters of 10 tablets 1 bottle of 30 tablets 
3 pretisni omoti, ki vsebujejo po 10 tablet 1 plastenka s 30 tabletami
• itraconazole (medicine to treat fungi) 
• itrakonazol (zdravilo za zdravljenje glivic)
Interactions leading to increased plasma concentration of felodipine CYP3A4 enzyme inhibitors have been shown to cause an increase in felodipine plasma concentrations. 
Medsebojna delovanja, ki povečajo koncentracijo felodipina v plazmi Ugotovljeno je, da zaviralci encimov CYP3A4 povečajo koncentracijo felodipina v plazmi.
14 tablets 20 tablets 28 tablets 30 tablets 90 tablets 98 tablets 100 tablets 
14 tablet 20 tablet 28 tablet 30 tablet 90 tablet 98 tablet 100 tablet
• ketoconazole (medicine to treat fungi) 
• ketokonazol (zdravilo za zdravljenje glivic)
<[To be completed nationally]> 
<[Izpolni država članica.
felodipine 
felodipin
4 blisters of 7 tablets 
4 pretisni omoti, ki vsebujejo po 7 tablet
No disturbances of fertility were observed when doses within the therapeutic range were given to rats. 
Če so podganam dajali odmerke, ki so bili v terapevtskem razponu, niso opažali motenj plodnosti.
• Burning/prickling/numbness 
• pekoč občutek/mravljinčenje/omrtvičenost
1 bottle of 30 tablets 3 blisters of 10 tablets 
1 plastenka s 30 tabletami 3 pretisni omoti, ki vsebujeja po 10 tablet
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. 
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.
Iron oxide reddish-brown (E172) (Only used for Plendil 5 mg and 10 mg) Iron oxide yellow (E172) 
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)
20 tablets 28 tablets 30 tablets 98 tablets 100 tablets 
20 tablet 28 tablet 30 tablet 98 tablet 100 tablet
Mild enlargement of the gums has been reported in patients with an inflammation in the mouth (gingivitis/periodontitis). 
Pri bolnikih, ki so imeli v ustih vnetje (gingivitis/periodontitis), je bilo opisano blago povečanje dlesni.
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). 
ki jih povzročita na primer telesna dejavnost ali stres (angina pektoris).
• phenytoin (medicine to treat epilepsy) 
• fenitoin (zdravilo za zdravljenje epilepsije)
2 blisters of 10 tablets 
2 pretisna omota, ki vsebujeta po 10 tablet
Each tablet contains 28 mg lactose and 10 mg polyoxyl 40 hydrogenated castor oil. 
Ena tableta vsebuje 28 mg laktoze in 10 mg makrogolglicerol hidroksistearata 40.
Musculoskeletal and connective tissue disorders 
Bolezni mišično-skeletnega sistema in vezivnega tkiva redki artralgija, mialgija
Haemodynamic effects 
Hemodinamski učinki
1 bottle of 100 tablets 10 blisters of 10 tablets 
1 plastenka s 100 tabletami 10 pretisnih omotov, ki vsebujejo po 10 tablet
14 tablets 20 tablets 28 tablets 30 tablets 98 tablets 100 tablets 
14 tablet 20 tablet 28 tablet 30 tablet 98 tablet 100 tablet
7 blisters of 14 tablets 
7 pretisnih omotov, ki vsebujejo po 14 tablet
MARKETING AUTHORISATION NUMBER(S) [To be completed nationally] 
ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET
Iron oxide reddish-brown (E172) Iron oxide yellow (E172) Hypromellose 6 mPa·s Macrogol 6000 
[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)
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. 
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.
Hypotension Syncope 
Odmerjanje Hipertenzija
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. 
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.
Each tablet contains 28 mg lactose and 2.5 mg polyoxyl 40 hydrogenated castor oil. 
Ena tableta vsebuje 28 mg laktoze in 2,5 mg makrogolglicerol hidroksistearata 40.
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. 
Rumena, okrogla, bikonveksna tableta s premerom 8,5 mm, ki ima na eni strani vtisnjeno oznako A/FL in na drugi strani 2,5.
Each tablet contains 28 mg lactose and 5 mg polyoxyl 40 hydrogenated castor oil. 
Ena tableta vsebuje 28 mg laktoze in 5 mg makrogolglicerol hidroksistearata 40.
Enzyme inhibiting and enzyme inducing substances of cytochrome P450 isoenzyme 3A4 may exert an influence on the plasma level of felodipine. 
Snovi, ki zavrejo ali inducirajo izoencime 3A4 citokroma P450, lahko vplivajo na koncentracijo felodipina v plazmi.
Renal impairment Dose adjustment is not needed in patients with impaired renal function. 
Okvara ledvic Bolnikom z okvarjenim delovanjem ledvic odmerka ni treba prilagoditi.
Concomitant administration of drugs that strongly induce or inhibit CYP3 A4 enzymes result in extensively decreased or increased plasma levels of felodipine, respectively. 
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).
Felodipine has a natriuretic and diuretic effect due to reduced tubular reabsorption of filtered sodium. 
Zaradi zmanjšane tubularne reabsorpcije filtriranega natrija deluje felodipin natriuretično in diuretično.
• cimetidine (medicine to treat gastric ulcers) 
• cimetidin (zdravilo za zdravljenje razjed na želodcu)
Cardiac effects 
Učinki na ledvice
3 blisters of 30 tablets 
3 pretisni omoti, ki vsebujejo po 30 tablet
Felodipine may cause significant hypotension with subsequent tachycardia. 
Felodipin lahko povzroči pomembno hipotenzijo in posledično tahikardijo; dovzetnim bolnikom se lahko zaradi tega pojavi ishemija miokarda.
Pollakisuria 
Dojenje
Contents of the pack and other information 
Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Plendil
Gingival hyperplasia, gingivitis 
Bolezni prebavil občasni redki zelo redki navzea, bolečine v trebuhu bruhanje hiperplazija dlesni, gingivitis
Dose-dependent ankle swelling can occur in patients treated with felodipine. 
Bolnikom, ki jemljejo felodipin, se lahko pojavi od odmerka odvisno otekanje gležnjev.
The tablet is pink, circular, biconvex, engraved A/Fm on one side and 5 on the other side, with a diameter of 9 mm. 
Rožnata, okrogla, bikonveksna tableta s premerom 9 mm, ki ima na eni strani vtisnjeno oznako A/Fm in na drugi strani 5.
The pharmacokinetics of felodipine is not changed in patients with renal impairment, including those treated with haemodialysis. 
Farmakokinetika felodipina pri bolnikih z okvaro ledvic
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. 
Rdečkasto-rjava, okrogla, bikonveksna tableta s premerom 9 mm, ki ima na eni strani vtisnjeno oznako A/FE in na drugi strani 10.
Uncommon: may affect up to 1 in 100 people 
• vročinski oblivi Občasni: pojavijo se lahko pri največ 1 od 100 bolnikov
• Muscular pain 
• bolečine v trebuhu
You should tell your doctor as soon as possible if you become pregnant while using this medicine. 
Če med uporabo tega zdravila zanosite, morate to čim prej povedati zdravniku.
10 blisters of 10 tablets 
10 pretisnih omotov, ki vsebujejo po 10 tablet
Very rare: may affect up to 1 in 10,000 people 
• impotenca/motnja spolnega delovanja Zelo redki: pojavijo se lahko pri največ 1 od 10.000 bolnikov
• Pregnancy 
• nosečnost
High-density polyethylene bottle with a cap of polypropylene PVC/PVDC blister and Aluminum blister 
PVC/PVDC pretisni omot in aluminijski pretisni omot.
Felodipine Cmax and AUC increased 8-fold and 6-fold, respectively, when felodipine was coadministered with the strong CYP3A4 inhibitor itraconazole. 
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.
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. 
Zdravilo Plendil ni priporočljivo za matere, ki dojijo.
CLINICAL PARTICULARS 4.1 Therapeutic indications Hypertension 
4.1 Terapevtske indikacije hipertenzija stabilna angina pektoris.
PACKAGE LEAFLET 
Velikost pakiranja
LIST OF EXCIPIENTS Contains lactose and polyoxyl 40 hydrogenated castor oil. 
Vsebuje laktozo in makrogolglicerol hidroksistearat 40.
The renal vascular resistance is decreased by felodipine. 
Felodipin zmanjša upor ledvičnih žil.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 2.5 mg felodipine. 
Ena tableta vsebuje 2,5 mg felodipina.
Tablet core: 
Preglednica 1.
• Pain in joints 
• otekanje gležnjev
Nausea, abdominal pain Vomiting 
Bolezni živčevja pogosti občasni glavobol omotica, parestezije
Results are presented above. 
Rezultati so predstavljeni zgoraj.
The frequency of these two side effects is not known. 
Pogostnost teh dveh neželenih učinkov ni znana.
Stabilization of the symptoms had to be obtained before the end of the first 14 days of each treatment period. 
Stabilizacijo simptomov je bilo treba doseči pred koncem prvih 14 dni vsakega obdobja zdravljenja.
Opening date : 
Datum odprtja:
Moreover three supportive studies were conducted in 34 paediatric patients. 
Poleg tega so opravili tri podporne študije pri 34 pediatričnih bolnikih.
Patients should be instructed not to increase the dosage on their own. 
Bolnikom je treba naročiti, naj ne povečujejo odmerka sami.
Difference in LS means (95% confidence limits) 
Razlika v povprečnih NK (95 % meje zaupanja)
Approximately half of the patients were ages 1 to 3 years. 
Približno pol bolnikov je bilo starih od 1 do 3 let.
No clinically relevant interactions are expected. 
Klinično pomembnih interakcij ni pričakovati.
N: number of patients; SD: standard deviation; LS: least squares. 
N: število bolnikov; SD: standardna deviacija; NK: najmanjši kvadrati.
If your doctor advises you to increase the number of capsules you take each day, you should do so slowly over several days. 
Če vam zdravnik svetuje povečanje števila kapsul, ki jih jemljete vsak dan, morate to narediti počasi, v roku nekaj dni.
Twelve patients completed the study. 
Študijo je zaključilo dvanajst bolnikov.
Keep taking your medicine until your doctor tells you to stop. 
Zdravilo jemljite, dokler vam zdravnik ne naroči, da prenehajte.
Other reported clinical experience has not identified differences in responses between the elderly and young patients. 
Druge klinične izkušnje, o katerih so poročali, ne kažejo na razlike v odzivu med starejšimi in mlajšimi bolniki.
Wait until your next meal, and take your usual number of capsules with your meal. 
Počakajte do naslednjega obroka in ob obroku vzemite običajno število kapsul.
You may also sprinkle the granules directly into your child's mouth. 
Zrnca lahko stresete tudi neposredno v otrokova usta.
Very common (may affect more than 1 in 10 people): stomach pain. 
Zelo pogosti (lahko se pojavijo pri več kot 1 od 10 oseb): bolečine v trebuhu.
Variable statistic 
Statistika spremenljivk
The primary objective was to assess the acceptability of 2 modes of administration using an acceptability questionnaire that was completed by the caregiver. 
Primarni cilj je bil oceniti sprejemljivost 2 načinov dajanja z vprašalnikom o sprejemljivosti, ki ga je izpolnil negovalec.
Overall, caregivers were satisfied with using apple sauce as a dosing method compared with apple juice. 
Na splošno so bili negovalci bolj zadovoljni z uporabo jabolčne čežane kot načina odmerjanja v primerjavi z jabolčnim sokom.
Do not take more capsules in a day than the amount your doctor has told you (total daily dose). 
V enem dnevu ne vzemite več kapsul, kot vam jih je priporočil zdravnik (celotni dnevni odmerek).
Changes in dosage may require an adjustment period of several days. 
Ob spremembi odmerka bo morda potrebno večdnevno prilagoditveno obdobje.
Anaphylactic shock is a severe, potentially life-threatening allergic reaction that can develop rapidly. 
Anafilaktični šok je huda, potencialno smrtno nevarna alergijska reakcija, ki se lahko hitro razvije.
If this reaction occurs, patients should be advised to discontinue treatment immediately and seek urgent medical assistance. 
Če nastopi taka reakcija, je treba bolnikom svetovati, naj nemudoma prekinejo zdravljenje in poiščejo nujno zdravniško pomoč.
Standard treatment (N=83) 
Standardno zdravilo (N = 83)
The pivotal study PR-005 was conducted in Europe. 
Ključna študija PR-005 je bila opravljena v Evropi.
The safety and efficacy in the paediatric patients in this study was similar to the adult patients. 
Varnost in učinkovitost pri pediatričnih bolnikih v tej študiji sta bili podobni kot pri odraslih bolnikih.
Other possible side effects may include: 
Drugi neželeni učinki so lahko:
Children (over 1 year of age), adolescents and adults 
Otroci (starejši od 1 leta), mladostniki in odrasli
If required, carefully open the capsule and administer the contents (granules) to the patient as described in section 4.2. 
Po potrebi previdno odprite kapsulo in dajte vsebino (zrnca) bolniku, kot je opisano v poglavju 4.2.
Enzepi is indicated in infants, children, adolescents and adults. 
Zdravilo Enzepi je indicirano pri dojenčkih, otrocih, mladostnikih in odraslih.
Therapy should be initiated at the lowest recommended dose and gradually increased under medical supervision with careful monitoring of the patient's response and symptoms. 
Zdravljenje je treba začeti z najmanjšim priporočenim odmerkom, ki se postopoma povečuje pod zdravniškim nadzorom ter ob natančnem spremljanju bolnikovega odziva in simptomov.
The mixture must not be stored. 
Mešanica se ne sme shraniti.
If you or your child eat a lot of meals or snacks in a day, be careful not to go over your total daily dose of Enzepi. 
Če vi ali vaš otrok v enem dnevu pojeste veliko obrokov in prigrizkov, bodite previdni, da ne presežete predpisanega celotnega dnevnega odmerka zdravila Enzepi.
Study PR-018 was a 12-month open-label extension of Study PR-011. 
Študija PR-018 je bila 12-mesečno odprto podaljšanje študije PR-011.
Severe allergic reaction 
Huda alergijska reakcija
Do not take Enzepi - if you are allergic to the active subtance or any of the other ingredients of this medicine (listed in section 6). 
Ne jemljite zdravila Enzepi: če ste alergični na zdravilno učinkovino ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
Patients unable to swallow capsules whole 
Bolniki, ki ne morejo pogoltniti cele kapsule
Do not take a double dose or extra capsules to make up for a forgotten dose. 
Ne vzemite dvojnega odmerka ali dodatnih kapsul, če ste pozabili vzeti prejšnji odmerek.
There was no wash-out period. 
Obdobja izplavljanja ni bilo.
If you are diabetic, you should speak with your doctor, if you notice any changes in your blood glucose levels. 
Če ste sladkorni bolnik, se morate posvetovati z zdravnikom, če opazite kakršne koli spremembe v ravni glukoze v krvi.
Adequate caloric intake during pregnancy is important for normal maternal weight gain and foetal growth. 
Zadosten vnos kalorij med nosečnostjo je pomemben za normalno materino pridobivanje telesne mase in rast ploda.
Depending on what strength of Enzepi you take, your doctor will tell you how many capsules you need to take with each meal or snack. 
Odvisno od tega, katero jakost zdravila Enzepi boste jemali, vam bo zdravnik povedal, koliko kapsul morate vzeti z vsakim obrokom ali prigrizkom.
Do not use this medicine after the expiry date which is stated on the carton and the bottle after EXP. 
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in plastenki poleg oznake »EXP«.
Higher doses should be used with caution if warranted (see sections 4.4 and 4.9) and only if they are documented to be effective by 3day faecal fat measurements that indicate a significantly improved coefficient of fat absorption. 
Večje odmerke je treba uporabljati previdno, kadar so res potrebni (glejte poglavji 4.4 in 4.9), in samo, če so dokazano učinkoviti glede na 3-dnevne meritve maščob v blatu, ki kažejo pomembno izboljšan koeficient absorpcije maščob.
No specific adverse reactions were identified in the elderly population. 
Pri starejši populaciji niso ugotovili nobenih posebnih neželenih učinkov.
MedDRA System Organ Classification and are ranked under headings of frequency, using the following categories: 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) and not known (cannot be estimated from the available data). 
Po pogostnosti so razvrščeni v te kategorije: 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) in neznana (ni mogoče oceniti iz razpoložljivih podatkov).
Enzepi can only be sprinkled on certain food (see section 3). 
Zdravilo Enzepi se sme posuti samo na določeno hrano (glejte poglavje 3).
Look into your child's mouth to make sure that all the medicine has been swallowed. 
Poglejte v otrokova usta, da preverite, ali je zaužil celotni odmerek zdravila.
Supportive measures including stopping pancreatic enzyme therapy and ensuring adequate rehydration are recommended. 
Priporočajo se podporni ukrepi, vključno s prenehanjem zdravljenja z encimi trebušne slinavke in zagotavljanjem ustrezne rehidracije.
6.6 Special precautions for disposal and other handling Use in paediatric population 
6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Uporaba pri pediatrični populaciji
The difference in means was -1.25 (95% CI, -3.62 to 1.12), with p=0.2972. 
Razlika v srednjih vrednostih je bila -1,25 (95 % IZ, od -3,62 do 1,12), p = 0,2972.
Pack size of 20, 50, 100, and 200 capsules. 
Velikosti pakiranj: 20, 50, 100 in 200 kapsul.
For each snack, half of the prescribed Enzepi dose for a full meal should be given. 
Ob vsakem prigrizku je treba vzeti polovico odmerka zdravila Enzepi, predpisanega za poln obrok.
If this occurs, call for urgent medical attention straightaway. 
Če se to zgodi, takoj pokličite nujno zdravniško pomoč.
There are no adequate data from the use of this medicinal product in pregnant women. 
O uporabi tega zdravila pri nosečnicah ni ustreznih podatkov.
If an allergic reaction occurs, stop your treatment and talk to your doctor. 
Če se pojavi alergijska reakcija, prenehajte z zdravljenjem in se posvetujte z zdravnikom.
Model-based statistics (Enzepi minus Creon) LS mean (standard error) 
Statistika na podlagi modela (Enzepi minus Kreon) Povprečni NK (standardna napaka)
Patients were administered Enzepi at the same dose they were taking at the end of Study PR-011. 
Bolniki so prejemali zdravilo Enzepi v enakem odmerku kot ob koncu študije PR-011.
OTHER SPECIAL WARNING(S), IF NECESSARY Do not swallow the desiccant. 
DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA Ne pogoltnite sušilnega sredstva.
Twelve patients completed both assigned treatment arms and were evaluated. 
Dvanajst bolnikov je zaključilo zdravljenje v obeh skupinah in so bili ocenjeni.
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. 
V vsaki skupini pogostnosti so neželeni učinki našteti po padajoči resnosti.
Many patients will need to take pancreatic enzyme replacement medicines for the rest of their life. 
Številni bolniki bodo morali nadomestna encimska zdravila z encimi trebušne slinavke jemati do konca življenja.
Reduced maternal weight gain and malnutrition can be associated with adverse pregnancy outcomes. 
Zmanjšano povečevanje telesne mase matere in podhranjenost sta lahko povezani z neželenimi izidi nosečnosti.