FrancophonIA/ELRC3.0 huggingface dataset:
English: Pack size of 20, 50, 100, and 200 capsules.
Maltese: Daqs tal-pakkett ta' 20, 50, 100, u 200 kapsula.
English: Study EUR-1008-M
Maltese: Studju EUR-1008-M
English: Standard treatment (N=83)
Maltese: Kura standard (N=83)
English: Manufacturer Adare Pharmaceuticals Srl Via Martin Luther King, 13 20060, Pessano Con Bornago Milan
Maltese: Adare Pharmaceuticals Srl Via Martin Luther King, 13 20060, Pessano Con Bornago Milan
English: Difference in LS means (95% confidence limits)
Maltese: Differenza f'medja LS (95% tal-limiti ta' kunfidenza)
English: N: number of patients; SD: standard deviation; LS: least squares.
Maltese: N: numru ta' pazjenti; SD: devjazzjoni standard; LS: l-inqas kwadrati.
English: Children (over 1 year of age), adolescents and adults
Maltese: Tfal (aktar mill-età ta' sena), adolexxenti u adulti
English: The difference in means was -1.25 (95% CI, -3.62 to 1.12), with p=0.2972.
Maltese: Id-differenza fil-medja kienet ta' -1.25 (95% CI, -3.62 sa 1.12), b'p=0.2972.
English: Variable statistic
Maltese: Varjabbli statistika
English: Opening date :
Maltese: Data tal-ftuħ:
English: * Ph. Eur.
Maltese: * Unitajiet Ph. Eur.
English: *Ph. Eur.
Maltese: *Unitajiet Ph. Eur.
English: Study EUR 1009-M
Maltese: Studju EUR-1009-M
English: - The other ingredients are: o Capsule content: croscarmellose sodium, hydrogenated castor oil, colloidal anhydrous silica, cellulose microcrystalline, magnesium stearate, hypromellose phthalate, talc, triethyl citrate.
Maltese: o Kontenut tal-kapsula: croscarmellose sodium, hydrogenated castor oil, colloidal anhydrous silica, cellulose microcrystalline, magnesium stearate, hypromellose phthalate, talc, triethyl citrate.
English: not less than 7,800 Ph. Eur.
Maltese: 7,800 unità Ph. Eur.
English: Study PR-011
Maltese: Studju PR-011
English: Potential for irritation to oral mucosa
Maltese: Potenzjal għal irritazzjoni tal-mukoża orali
English: Study PR-005
Maltese: Studju PR-005
English: Summary statistics Mean (SD)
Maltese: Statistiċi sommarji Medja (SD)
English: Study PR-018
Maltese: Studju PR-018
English: Dyspnoea*
Maltese: Dispnea*
English: o Capsule shell :
Maltese: o Qoxra tal-kapsula :
English: units amylase:
Maltese: amylase:
English: Adare Pharmaceuticals Srl Via Martin Luther King 13 20060 Pessano Con Bornago ITALY
Maltese: Adare Pharmaceuticals Srl Via Martin Luther King 13 20060
English: Capsule content (gastro-resistant granules) Croscarmellose sodium Hydrogenated castor oil Colloidal anhydrous silica Microcrystalline cellulose Magnesium stearate
Maltese: Hydrogenated castor oil Colloidal anhydrous silica Microcrystalline cellulose Magnesium stearate
English: units For the full list of excipients, see section 6.1.
Maltese: Għal-lista kompluta ta' eċċipjenti, ara sezzjoni 6.1.
English: The most common adverse reactions reported with Enzepi were gastrointestinal complaints [abdominal pain (16%); flatulence (12%); abdominal distention (7%); diarrhoea and vomiting (6%); constipation (5%); nausea (3%)], and headache occurring in approximately 6% of patients.
Maltese: L-aktar reazzjonijiet avversi komuni rrapportati b'Enzepi kienu lmenti gastro-intestinali [uġigħ addominali, (16%); gass (12%); nefħa addominali (7%); dijarea u rimettar (6%); stitikezza (5%); dardir (3%)]; u uġigħ ta' ras li jseħħ f'bejn wieħed u ieħor 6% tal-pazjenti.
English: Anaphylactic reaction** Drug hypersensitivity/ Hypersensitivity
Maltese: Reazzjoni anafilattika** Sensittività eċċessiva għall mediċina/
English: Mean CFA-72h was 88% with Enzepi treatment compared to 63% with placebo treatment.
Maltese: Is-CFA-72h medju kien ta' 88% b'kura b'Enzepi meta mqabbel ma' 63% b'kura bil-plaċebo.
English: The mean difference in CFA-72h was 26 percentage points greater with Enzepi treatment with a 95% Confidence Interval of (19, 32) and p<0.001.
Maltese: Id-differenza medja fis-CFA-72h kienet ta' 26 punt perċentwali aktar mill-kura Enzepi b'95% ta' Intervall ta' Kunfidenza ta' (19, 32) u p<0.
English: 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).
Maltese: Huma ppreżentati skont is-Sistema tal-klassifika tal-organi MedDRA u huma elenkati taħt intestaturi ta' frekwenza, bl-użu ta' dawn il-kategoriji li ġejjin: komuni ħafna (≥1/10); komuni (≥1/100 sa <1/10); mhux komuni (≥1/1,000 sa <1/100); rari (≥1/10,000 sa <1/1,000); rari ħafna (<1/10,000) u mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: Allergan Norden AB Tlf: + 4580884560
Maltese: Tlf: + 4580884560
English: not less than 3,200 units*
Maltese: mhux anqas min 3,200 unità*
English: Marketing Authorisation Holder Allergan Pharmaceuticals International Limited Clonshaugh Industrial Estate Coolock
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq Allergan Pharmaceuticals International Limited Clonshaugh Industrial Estate Coolock
English: Rarely, anaphylactic reactions have been reported with pancreatic enzyme products with different formulations of the same active ingredient (pancreas powder).
Maltese: Rarament, ġew irrapportati reazzjonijiet anafilattiċi ma' prodotti tal-enzimi pankreatiċi b'formulazzjonijiet differenti tal-istess ingredjent attiv (trab pankreatiku).
English: The number of responders (patients with less than 30% faecal fat content and without signs and symptoms of malabsorption) at baseline was 10/19 (52.6%), 13/19 (68.4%) after 1 week of treatment (stabilization) and 11/19 (57.9%) after the second week of open-label treatment with Enzepi.
Maltese: In-numru ta' dawk li rrispondew (pazjenti b'inqas minn 30% ta' kontenut ta' xaħam fl-ippurgar u mingħajr sinjali u sintomi ta' malassorbiment) fuq il-linja bażi kien ta' 10/19 (52.6%), 13/19 (68.4%) wara ġimgħa ta' kura (stabbilizzazzjoni) u 11/19 (57.9%) wara t-tieni ġimgħa ta' kura miftuħa b'Enzepi.
English: Model-based statistics (Enzepi minus Creon) LS mean (standard error)
Maltese: Statistiċi bbażati fuq mudell (Enzepi mingħajr Creon) Medja LS (żball standard)
English: not less than 270 units*
Maltese: mhux inqas minn 270 unità*.
English: Nordmark Arzneimittel GmbH & Co. KG Pinnauallee 4
Maltese: Nordmark Arzneimittel GmbH & Co.
English: EUR-1008-M was conducted in 34 patients with EPI due to CF, 26 of whom were children, including 8 children aged 7 to 11 years, and 18 adolescents aged 12 to 17 years.
Maltese: EUR-1008-M sar fuq 34 pazjent bl-EPI minħabba s-CF, fejn 26 minnhom kienu tfal, inkluż 8 itfal fl-etajiet ta' 7 sa 11-il sena, u 18-il adolexxent fl-etajiet ta' 12 sa 17-il sena.
English: Allergan Norden AB Tlf: +47 80 01 04 97
Maltese: Tlf: +47 80 01 04 97
English: units protease:
Maltese: protease:
English: Potential for hyperuricaemia
Maltese: Potenzjal ta' iperurikemija
English: 25,000 Ph. Eur.
Maltese: 25,000 unità Ph. Eur.
English: enzymes, Enzyme preparations, ATC code: A09AA02
Maltese: Diġestivi, inkl, enzimi, Preparazzjonijiet tal-enzimi, Kodiċi ATC:
English: - proteolytic activity:
Maltese: - attività proteolitika:
English: Children (between 1 and 4 years of age)
Maltese: Tfal (bejn sena u 4 snin ta' età)
English: Sodium This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially `sodium-free´.
Maltese: Dan il-prodott mediċinali fih anqas minn 1 mmol sodium (23 mg) f'kull doża, jiġifieri essenzjalment ‘ħieles mis-sodium'.
English: 40,000 Ph. Eur.
Maltese: 40,000 unità Ph. Eur.
English: not less than 130 units*
Maltese: mhux inqas minn 130 unità*.
English: Fibrosing colonopathy** Lip swelling and swollen tongue*
Maltese: Kolonpatija tal-fibrożi** Nefħa fix-xoffa u lsien minfuħ*
English: 20 gastro-resistant hard capsules 50 gastro-resistant hard capsules 100 gastro-resistant hard capsules 200 gastro-resistant hard capsules
Maltese: 20 kapsula iebsa gastro-reżistenti 50 kapsula iebsa gastro-reżistenti 100 kapsula iebsa gastro-reżistenti 200 kapsula iebsa gastro-reżistenti
English: After first opening: 6 months when stored below 25°C.
Maltese: 6 xhur meta maħżun f'temperatura inqas minn 25°C.
English: Capsule shell Hypromellose Carrageenan (E407) Potassium chloride Titanium dioxide (E171) Carnauba wax Purified water
Maltese: Qoxra tal-kapsula Hypromellose Carrageenan (E407) Potassium chloride Titanium dioxide (E171) Carnauba wax Ilma purifikat
English: Fertility No human data on the effect of Enzepi on fertility are available.
Maltese: Fertilità Mhemm l-ebda dejta umana disponibbli dwar l-effett ta' Enzepi fuq il-fertilità.
English: No clinically relevant interactions are expected.
Maltese: Ma hija mistennija l-ebda interazzjoni klinikament relevanti.
English: Other reported clinical experience has not identified differences in responses between the elderly and young patients.
Maltese: Esperjenza klinika oħra rrapportata ma identifikatx differenzi fir-risponsi bejn il-pazjenti anzjani u żgħażagħ.
English: Pack size: one bottle of 20, 50, 100 or 200 gastro-resistant hard capsules.
Maltese: Daqs tal-pakkett: flixkun wieħed ta' 20, 50, 100 jew 200 kapsula iebsa gastro-reżistenti.
English: not less than 7,800 units*
Maltese: mhux inqas minn 7,800 unità*,
English: INFORMATION IN BRAILLE Enzepi 40,000
Maltese: INFORMAZZJONI BIL-BRAILLE Enzepi 40,000
English: INFORMATION IN BRAILLE Enzepi 25,000
Maltese: INFORMAZZJONI BIL-BRAILLE Enzepi 25,000
English: 25,000 units*
Maltese: 25,000 unità*
English: Printing ink Shellac
Maltese: Inka tal-istampar Shellac
English: Allergan Baltics UAB Tel: + 37 052 072 777
Maltese: Tel: + 37 052 072 777
English: Abdominal discomfort
Maltese: Skumdità addominali
English: not less than 650 Ph. Eur.
Maltese: 650 unità Ph. Eur.
English: 5,000 Ph. Eur.
Maltese: 5,000 unità Ph. Eur.
English: 10,000 Ph. Eur.
Maltese: 10,000 unità Ph. Eur.
English: The maximum recommended total dose is 2,500 lipase units/kg of body weight per meal (or 10,000 lipase units/kg of body weight per day), or 4,000 lipase units/g fat ingested per day.
Maltese: Id-doża massima rakkomandata totali hija ta' 2,500 unità ta' lipażi/kg tal-piż tal-ġisem għal kull ikla (jew 10,000 unità ta' lipażi/kg tal-piż tal-ġisem kuljum), jew 4,000 unità ta' lipażi/g xaħam inġestita kuljum.
English: A total of 96 patients, aged 12 to 43 years, were randomized in the intent-to-treat population.
Maltese: Total ta' 96 pazjent, fl-età ta' bejn it-12 sal-43 sena, ġew randomizzati b'mod każwali fil-popolazzjoni bliskop li tiġi kkurata.
English: Clinical studies of Enzepi did not include sufficient numbers of subjects aged 65 and over to determine whether they respond different from younger subjects.
Maltese: Studji kliniċi ta' Enzepi ma inkludewx numri suffiċjenti ta' individwi fl-età ta' 65 sena u aktar sabiex jiddeterminaw jekk jirrispondux b'mod differenti minn individwi żgħażagħ.
English: 25,000 units*,
Maltese: 25,000 unità*,
English: Cystic fibrosis patients
Maltese: Kolonopatija fibrosizzanti
English: C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION Periodic safety update reports The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: Ir-rekwiżiti tar-rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tadDirettiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikat fuq il-portal elettroniku Ewropew tal-mediċini.
English: The most relevant class effects of the pancreatic enzyme products include fibrosing colonopathy, hyperuricaemia/ hyperuricosuria and anaphylactic reactions.
Maltese: L-aktar effetti ta' klassi relevanti tal-prodotti tal-enzimi pankreatiċi jinkludu l-kolonopatija fibrosizzanti, iperurikemija/ iperurikosurja u reazzjonijiet anafilattiċi.
English: 40,000 units*
Maltese: 40,000 unità*
English: Not known (frequency cannot be estimated from the available data): abnormal/discoloured faeces (stools) or frequent bowel movements shortness of breath indigestion swelling, pain, soreness or irritation in the mouth tiredness or general feeling of being unwell (malaise) changes (increase or decrease) in blood glucose levels changes (increase or decrease) in body weight decreased appetite high uric acid level in the urine (hyperuricosuria) high uric acid level in the blood (hyperuricemia).
Maltese: Mhux magħruf (il-frekwenza ma tistax tiġi stmata mid-data disponibbli): ippurgar anormali/li tilef il-kulur jew moviment frekwenti tal-musrana qtugħ ta' nifs indiġestjoni nefħa, uġigħ, skumdità jew irritazzjoni fil-ħalq għejja jew tħossok ma tiflaħx b'mod ġenerali (telqa) bidliet (żieda jew tnaqqis) fil-livelli tal-glukożju fid-demm bidliet (żieda jew tnaqqis) fil-piż tal-ġisem nuqqas ta' aptit livell għoli ta' aċidu uriku fl-awrina (iperurikosurja) livell għoli ta' aċidu uriku fid-demm (iperurikemija)
English: Table 1 Analysis of coefficient of fat absorption over 72 hours (CFA72h) - completers population (study : PR005)
Maltese: Tabella 1 Analiżi ta' koeffiċjent tal-assorbiment tax-xaħam fuq 72 siegħa (CFA-72h)Popolazzjoni ta' dawk li temmew (Studju: PR-005)
English: 40,000 units*,
Maltese: 40,000 unità*,
English: Additionally for Enzepi 40,000 units gastro-resistant granules Indigotine (E132)
Maltese: B'żieda għal Enzepi 40,000 unità granijiet gastro-reżistenti Indigotine (E132)
English: 5,000 units*
Maltese: 5,000 unità*
English: The most important serious side effects seen with other pancreatic enzyme replacement medicines are ‘anaphylactic shock' and fibrosing colonopathy.
Maltese: L-aktar effetti sekondarji serji importanti li jidhru ma' mediċini ta' sostituzzjoni ta' enzimi pankreatiċi oħra huma ‘xokk anafilattiku' u kolonopatija fibrosizzanti.
English: The safety profile of Enzepi in the paediatric population was similar to that observed in adults.
Maltese: Il-profil tas-sigurtà ta' Enzepi fil-popolazzjoni pedjatrika kien simili għal dak osservat fl-adulti.
English: 5,000 units*,
Maltese: 5,000 unità*,
English: INFORMATION IN BRAILLE Enzepi 10,000
Maltese: INFORMAZZJONI BIL-BRAILLE Enzepi 10,000
English: Enzepi 5,000 units gastro-resistant hard capsules Enzepi 10,000 units gastro-resistant hard capsules Enzepi 25,000 units gastro-resistant hard capsules Enzepi 40,000 units gastro-resistant hard capsules
Maltese: Enzepi 5,000 unità kapsuli ibsin gastro-reżistenti Enzepi 10,000 unità kapsuli ibsin gastro-reżistenti Enzepi 25,000 unità kapsuli ibsin gastro-reżistenti Enzepi 40,000 unità kapsuli ibsin gastro-reżistenti
English: 10,000 units*
Maltese: 10,000 unità*
English: Study PR-018 was a 12-month open-label extension of Study PR-011.
Maltese: Studju PR-018 kien estensjoni bit-tikketta mikxufa ta' 12-il xahar tal-Istudju PR-011.
English: Pancreatic enzyme replacement treatment in exocrine pancreatic insufficiency due to cystic fibrosis or other conditions (e.g. chronic pancreatitis, post pancreatectomy or pancreatic cancer).
Maltese: Kura ta' sostituzzjoni ta' enzimi pankreatiċi f'insuffiċjenza pankreatika eżokrinali minħabba fibrożi ċistika jew kundizzjonijiet oħrajn (eż. pankreatite kronika, post pankreatektomija jew kanċer pankreatiku).
English: Enzepi is designed to release most of the enzymes in vivo at pH greater than 5.5.
Maltese: Enzepi huwa mfassal biex jirrilaxxa ħafna mill-enzimi in vivo f'pH aktar minn 5.5.
English: amylolytic activity: proteolytic activity:
Maltese: attività amilolitika: attività proteolitika:
English: Thus, Enzepi demonstrated both non-inferiority and equivalence to the comparator in fat absorption control (measured as CFA-72h) in adolescents and adults with CF-associated EPI.
Maltese: Għaldaqstant, Enzepi wera kemm non-inferjorità u ekwivalenza mal-komparatur fil-kontroll tal-assorbiment tax-xaħam (imkejjel bħala CFA-72h) f'adolexxenti u adulti b'EPI assoċjat mas-CF.
English: 10,000 units*,
Maltese: 10,000 unità*,
English: Allergan Norden AB Tel: + 46859410000
Maltese: Tel: + 46859410000
English: Additionally for Enzepi 25,000 units gastro-resistant granules Yellow iron oxide (E172)
Maltese: B'żieda għal Enzepi 25,000 unità granijiet gastro-reżistenti Yellow iron oxide (E172)
English: Paediatric population aged 4 years or older and adults (including elderly) For children aged 4 years or older, adolescents and adults the recommended starting dose is 500 lipase units/kg of body weight per meal.
Maltese: Popolazzjoni pedjatrika fl-età ta' 4 snin jew akbar u adulti (inkluż anzjani) Għal tfal fl-età ta' 4 snin jew aktar, adolexxenti u adulti, id-doża rakkomandata tal-bidu hija ta' 500 unità ta' lipażi/kg tal-piż tal-ġisem għal kull ikla.
English: not less than 650 units*
Maltese: mhux inqas minn 650 unità*.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/16/1113/001-016
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/16/1113/001-016
English: The most important serious adverse reactions observed with pancreatic enzyme medicinal products are anaphylactic reactions (see section 4.4) and fibrosing colonopathy (see section 4.4).
Maltese: L-aktar reazzjonijiet avversi serji importanti osservati bi prodotti mediċinali tal-enzimi pankreatiċi huma reazzjonijiet anafilattiċi (ara sezzjoni 4.4) u kolonopatija fibrosizzanti (ara sezzjoni 4.4).
English: not less than 410 units*
Maltese: mhux inqas minn 410 unità*.
English: In patients at risk of abnormal blood glucose levels glycaemic control may be affected by administration of pancreatic enzyme replacement therapy (see section 4.4).
Maltese: F'pazjenti f'riskju ta' livelli anormali tal-glukożju fid-demm il-kontroll glikimiku jista' jkun affetwat permezz tal-amministrazzjoni ta' terapija ta' sostituzzjoni tal-enzimi pankreatiċi (ara sezzjoni 4.4).
English: Children (over 4 years of age), adolescents and adults (including elderly) The recommended starting dose for children over 4 years of age, adolescents (12 to 18 years) and adults is 500 lipase units per kg of body weight per meal.
Maltese: Tfal (akbar mill-età ta' 4 snin), adolexxenti u adulti (inkluż anzjani) Id-doża tal-bidu rakkomandata fi tfal akbar minn 4 snin, adolexxenti ( 12 sa 18-il sena) u adulti hija ta' 500 unità ta' lipażi għal kull kg tal-piż tal-ġisem għal kull ikla.
English: Additionally for Enzepi 10,000 units gastro-resistant granules Yellow iron oxide (E172)
Maltese: B'żieda għal Enzepi 10,000 unità granijiet gastro-reżistenti Yellow iron oxide (E172)
English: Gastro-resistant hard capsule.
Maltese: Kapsula iebsa gastro-reżistenti.
English: not less than 4,800 units*
Maltese: mhux inqas minn 4,800 unità*,
English: Then, enzymes catalyze the hydrolysis of fats to monoglycerides, glycerol, and free fatty acids, protein into peptides and amino acids, and starch into dextrins and short chain sugars such as maltose and maltotriose in the duodenum and proximal small intestine, thereby acting like digestive enzymes physiologically secreted by the pancreas.
Maltese: Imbagħad, l-enzimi jikkatalizzaw l-idroliżi tax-xaħmijiet għal monogliċeridi, gliċerol, u l-aċidi grassi liberi, proteini fil-peptidi u l-aċidi amino, u lamtu fid-destrini u zokkor ta' katina qasira bħal maltożju u maltotriożju fid-duwodenu u l-musrana ż-żgħira prossimali, b'hekk jaġixxu bħal enzimi diġestivi fiżjoloġikament imnixxija mill-frixa.
English: The mean faecal fat content was similar at baseline (24.8%), after stabilization (27.0%) and after the second week of open-label treatment
Maltese: Il-kontenut medju ta' xaħam fl-ippurgar kien simili fil-linja bażi (24.8%), wara stabbilizzazzjoni (27.0%) u wara t-tieni ġimgħa ta' kura miftuħa b'Enzepi (27.3%).
English: Patients were randomized to receive Enzepi from an opened capsule mixed and administered with apple juice (in a syringe nurser) or apple sauce (using a spoon) for 10 days of treatment, followed by a cross-over to the alternate mode of administration for an additional 10 days.
Maltese: Il-pazjenti ġew randomizzati sabiex jirċievu Enzepi minn kapsula miftuħa mħallta u amministrata mal-meraq tat-tuffieħ (f'nurser ta' siringa) jew ma' puree tat-tuffieħ (permezz ta' mgħarfa) għal 10 ijiem ta' kura, segwit minn cross-over għall-modalità ta' amministrazzjoni alternattiva għal 10 ijiem addizzjonali.
English: The efficacy of Enzepi has been evaluated in one active-comparator study and one placebo-controlled study conducted in 130 patients with EPI (exocrine pancreatic insufficiency) associated with CF.
Maltese: L-effikaċja ta' Enzepi ġiet evalwata fi studju komparattiv attiv wieħed u fi studju wieħed ikkontrollat bi plaċebo li sar fuq 130 pazjent b'EPI (insuffiċjenza pankreatika eżokrinali) assoċjata ma' CF.
English: - amylolytic activity:
Maltese: - attività amilolitika:
English: The primary efficacy endpoint was the coefficient of fat absorption over 72 hours (CFA-72h) which was calculated at the end of each treatment period, from the stools collected during the last 3 days of each treatment period.
Maltese: Il-punt aħħari primarju tal-effikaċja kien il-koeffiċjenti ta' assorbiment ta' xaħam fuq 72 siegħa (CFA-72h) li kien ikkalkolat fit-tmiem ta' kull perjodu ta' kura, mill-ippurgar miġbur waqt l-aħħar 3 ijiem ta' kull perjodu ta' kura.
English: After a 4-14 days screening period on their usual PEP, patients received Enzepi at individually titrated doses ranging between 2,300 and 10,000 lipase units per kg body weight per day, with a mean of approximately 5,000 lipase units per kg body weight per day (not to exceed 2,500 lipase units per kilogram per meal) for 14 days.
Maltese: Wara 4-14-il jum ta' perjodu ta' skrinjar bil-PEP tagħhom tas-soltu, il-pazjenti rċevew Enzepi f'dożi titrati individwalment f'firxa ta' bejn 2,300 u 10,000 unità ta' lipażi għal kull kg tal-piż tal-ġisem kuljum, b'medja ta' bejn wieħed u ieħor 5,000 unità ta' lipażi għal kull kg tal-piż tal-ġisem kuljum (m'għandhomx jinqabżu l-2,500 unità ta' lipażi għal kull kilogramma kull ikla) għal 14-il jum.
English: Data generated in the CF population with EPI can be extrapolated to the other causes of EPI such as chronic pancreatitis, post pancreatectomy or pancreatic cancer.
Maltese: Data ġġenerata fil-popolazzjoni CF b'EPI tista' tiġi estrapolata għall-kawżi l-oħra tal-EPI bħal pankreatite kronika, post pankreatektomija jew kanċer pankreatiku.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each capsule contains: lipase:
Maltese: Kull kapsula fiha: lipase:
English: How to store Enzepi
Maltese: Kif taħżen Enzepi
English: Rash erythematous Pruritus
Maltese: Reazzjoni allerġika severa
English: Pancreas powder
Maltese: Trab pankreatiku
English: not less than 1,600 units*
Maltese: mhux inqas minn 1,600 unità*,
English: Frequency, type and severity of adverse reactions were similar in elderly people with pancreatic exocrine insufficiency as compared to adults.
Maltese: Il-frekwenza, it-tip u sseverità tar-reazzjonijiet avversi kienu simili f'nies anzjani b'insuffiċjenza pankreatika eżokrinali meta mqabbla mal-adulti.
English: Patients were randomized to receive Enzepi or matching placebo for 6 to 7 days of treatment, followed by cross-over to the alternate treatment for an additional 6 to 7 days.
Maltese: Il-pazjenti ġew randomizzati biex jirċievu Enzepi jew plaċebo simili għal 6 sa 7 ijiem ta' kura, segwit minn qlib għall-kura alternata għal 6 sa 7 ijiem oħra.
English: EUR 1009-M was an open-label, single arm study in 19 patients, ages 1 to 6 years, with EPI due to CF.
Maltese: EUR 1009-M kien studju miftuħ, b'fergħa waħda f'19-il pazjent, fl-etajiet ta' sena sa 6 snin, bl-EPI minħabba s-CF.
English: Abnormal faeces Faeces discoloured Frequent bowel movements
Maltese: Ippurgar mhux normali Ippurgar li tilef il-kulur Moviment frekwenti talimsaren
English: If you or your child have trouble swallowing Enzepi capsules, open carefully the capsules and sprinkle the contents (granules) on a small amount of acidic food such as fruit puree (apple/ pear), yoghurt, or juice (orange/pineapple/apple).
Maltese: Jekk inti jew it-tfal tiegħek għandkom problema biex tibilgħu l-kapsuli Enzepi, iftaħ il-kapsuli u raxxax ilkontenut (granijiet) fuq ammont żgħir ta' ikel aċidiku bħal puree tal-frott (tuffieħ/lanġas), jogurt, jew meraq (larinġ/ananas/tuffieħ).