FrancophonIA/ELRC3.0 huggingface dataset:
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreed subsequent updates of the RMP.
Maltese: Pjan tal-ġestjoni tar-riskju (RMP) L-MAH għandu jwettaq l-attivitajiet u l-interventi meħtieġa ta' farmakoviġilanza dettaljati fl-RMP maqbul ippreżentat fil-Modulu 1.8.2 tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u kwalunkwe aġġornament sussegwenti maqbul tal-RMP.
English: units proteolytic activity:
Maltese: attività proteolitika:
English: In clinical trials, 110 children with CF (cystic fibrosis) aged 1 month and older received Enzepi at a dose that ensured stabilization of symptoms.
Maltese: Fi provi kliniċi, 110 tfal b'CF (fibrożi ċistika) fl-età ta' xahar u aktar ingħataw Enzepi b'doża li żgurat listabbilizzazzjoni tas-sintomi.
English: Pancreatic enzyme medicinal products do not cause pharmacokinetic and pharmacodynamic interactions based on their pharmacology, as they are not absorbed from the gastrointestinal tract.
Maltese: Il-prodotti mediċinali tal-enzimi pankreatiċi ma jikkawżawx interazzjonijiet farmakokinetiċi jew farmakodinamiċi abbażi tal-farmakoloġija tagħhom, peress li mhumiex assorbiti mill-passaġġ gastrointestinali.
English: Enzepi 5,000 units: hypromellose, carrageenan (E407), potassium chloride, titanium dioxide E171, carnauba wax, water.
Maltese: Enzepi 5,000 unità: hypromellose, carrageenan (E407), potassium chloride, titanium dioxide (E171), carnauba wax, ilma.
English: Enzepi 5,000 units gastro-resistant hard capsules
Maltese: Enzepi 5,000 unità kapsuli ibsin gastro-reżistenti
English: 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).
Maltese: Tiħux Enzepi - jekk inti allerġiku għas-sustanza attiva jew għal xi sustanza oħra ta' din il-mediċina (elenkati fis sezzjoni 6).
English: Abdominal pain upper Dyspepsia
Maltese: Stitikezza Nefħa addominali
English: For patients who are unable to swallow capsules whole, the capsules may be carefully opened and the contents mixed (without crushing) with small amounts of acidic soft food of pH 5 or less (e.g., fruit puree [apple/ pear], yoghurt, juice [orange/pineapple/apple]).
Maltese: Għal pazjenti li ma jistgħux jibilgħu l-kapsuli sħaħ, il-kapsuli jistgħu jinfetħu bil-galbu u l-kontenut jitħallat (mingħajr ma jiġi mitħun) ma' ammonti żgħar ta' ikel artab aċidiku ta' pH 5 jew inqas (eż. puree tal-frott [tuffieħ/lanġas], jogurt, meraq [larinġ/ananas/tuffieħ]).
English: The Enzepi 40,000 units gastro-resistant hard capsule has a blue opaque cap and a white opaque body with ‘Enzepi 40' printed on it and contains light-brown gastro-resistant granules.
Maltese: Il-kapsula iebsa gastro-reżistenti Enzepi 40,000 unità għandha kappa opaka blu u korp opak abjad b'‘Enzepi 40' stampata u fiha granijiet gastro-reżistenti kannella ċari.
English: Enzepi 40,000 units gastro-resistant hard capsules
Maltese: Enzepi 40,000 unità kapsuli ibsin gastro-reżistenti
English: Enzepi 10,000 units gastro-resistant hard capsules One capsule contains 83.7 mg of pancreas powder including the following enzymatic activites: - lipolytic activity:
Maltese: Enzepi 10,000 unità kapsuli ibsin gastro-reżistenti Kapsula waħda fiha 83.7 mg ta' trab pankreatiku inkluż l-attivitajiet enzimatiċi li ġejjin: - attività lipolitika:
English: Tel: +48 22 256 3700
Maltese: Allergan Sp. z o.o. Tel: +48 22 256 3700
English: For infants below 1 year of age the recommended starting dose is 5,000 lipase units per meal (generally 120 ml of milk) (see section Method of administration).
Maltese: Għal trabi tat-twelid taħt l-età ta' sena, id-doża tal-bidu rakkomandata hija ta' 5,000 unità ta' lipażi għal kull ikla (ġeneralment 120 ml ta' ħalib) (ara s-sezzjoni Metodu ta' kif għandu jingħata).
English: The supportive EUR-1008-M, conducted in the US, was a randomized, double-blind, placebo-controlled, crossover study of 34 patients, ages 7 to 23 years, with EPI due to CF.
Maltese: L-istudju EUR-1008-M ta' appoġġ, li twettaq fl-Istati Uniti, kien studju każwali, fl-għama doppja, kkontrollat minn plaċebo, u inkroċjat, ta' 34 pazjent, fl-etajiet ta' bejn is-7 u t-23 sena, bl-EPI minħabba sCF.
English: Enzepi 25,000 units: hypromellose, carrageenan (E407), potassium chloride, titanium dioxide E171, carnauba wax, water, yellow iron oxide (E172), indigotine E132.
Maltese: Enzepi 25,000 unità: hypromellose, carrageenan (E407), potassium chloride, titanium dioxide (E171), carnauba wax, ilma, yellow iron oxide (E172), indigotine E132.
English: Enzepi 40,000 units gastro-resitant hard capsules One capsule contains 334.9 mg of pancreas powder including the following enzymatic activites: - lipolytic activity:
Maltese: Enzepi 40,000 unità kapsuli ibsin gastro-reżistenti Kapsula waħda fiha 334.9 mg ta' trab pankreatiku inkluż l-attivitajiet enzimatiċi li ġejjin: - attività lipolitika:
English: Allergan Baltics UAB Tel: + 371 676 60 831
Maltese: Tel: + 371 676 60 831
English: Enzepi 25,000 units gastro-resistant hard capsules One capsule contains 209.3 mg of pancreas powder including the following enzymatic activites: - lipolytic activity:
Maltese: Enzepi 25,000 unità kapsuli ibsin gastro-reżistenti Kapsula waħda fiha 209.3 mg ta' trab pankreatiku inkluż l-attivitajiet enzimatiċi li ġejjin: - attività lipolitika:
English: Elderly people
Maltese: TA' EĊĊIPJENTI
English: Enzepi 10,000 units: hypromellose, carrageenan (E407), potassium chloride, titanium dioxide E171, carnauba wax, water, yellow iron oxide (E172).
Maltese: Enzepi 10,000 unità: hypromellose, carrageenan (E407), potassium chloride, titanium dioxide (E171), carnauba wax, ilma, yellow iron oxide (E172).
English: The primary efficacy endpoint was the percentage of “responders”, defined as those patients without steatorrhoea (<30% faecal fat content) and without signs and symptoms of malabsorption after one and two weeks of treatment with Enzepi.
Maltese: Il-punt aħħari primarju tal-effikaċja kien il-perċentwal ta' “dawk li rrispondew”, definiti bħala dawk ilpazjenti mingħajr steatorrhoea (<30% kontentut tax-xaħam fl-ippurgar) u mingħajr sinjali u sintomi ta' malassorbiment wara ġimgħa u ġimagħtejn tal-kura b'Enzepi.
English: NAME OF THE MEDICINAL PRODUCT Enzepi 25,000 units gastro-resistant hard capsules Pancreas powder
Maltese: TAL-PRODOTT MEDIĊINALI Enzepi ta' 25,000 unità kapsuli ibsin gastro-reżistenti Trab pankreatiku
English: Anaphylactic reactions
Maltese: Sensittività eċċessiva
English: The recommended starting dose for infants below 1 year of age is 5,000 lipase units per 120 ml of formula milk or breast-milk.
Maltese: Id-doża tal-bidu rakkomandata għat-trabi taħt l-età ta' sena hija ta' 5,000 unità ta' lipażi għal kull 120 ml ta' ħalib tal-formula jew ħalib tas-sider.
English: As a precaution, unusual abdominal symptoms or changes in abdominal symptoms should be medically assessed to exclude the possibility of fibrosing colonopathy, especially if the patient is taking in excess of 10,000 lipase units/kg/day.
Maltese: Bħala prekawzjoni, sintomi addominali mhux tas-soltu jew bidliet fis-sintomi addominali għandhom jiġu vvalutati medikament sabiex tiġi eskluża l-possibilità ta' kolonopatija fibrosizzanti, speċjalment jekk il-pazjent ikun qed jieħu aktar minn 10,000 unità ta' lipażi/kg/jum.
English: The collection was performed in an approved, controlled environment that enabled supervised dietary intake and quantitative stool collection.
Maltese: Il-ġbir sar f'ambjent approvat u kkontrollat li ppermetta konsum fid-dieta sorveljat u ġbir ta' ppurgar kwantitattiv.
English: NAME OF THE MEDICINAL PRODUCT Enzepi 40,000 units gastro-resistant hard capsules Pancreas powder
Maltese: TAL-PRODOTT MEDIĊINALI Enzepi 40,000 unità kapsuli ibsin gastro-reżistenti Trab pankreatiku
English: Pancreatic enzymes are not absorbed from the gastrointestinal tract.
Maltese: L-enzimi pankreatiċi mhumiex assorbiti mill-passaġġ gastro-intestinali.
English: Chronic high doses of pancreatic enzyme products have been associated with fibrosing colonopathy and as a result in some cases colonic strictures (see sections 4.2 and 4.4).
Maltese: Dożi għoljin kroniċi ta' prodotti tal-enzimi pankreatiċi kienu assoċjati mal-kolonopatija fibrosizzanti u bħala riżultat f'xi każi ta' tidjiq koloniku (ara sezzjonijiet 4.2 u 4.4).
English: The primary efficacy endpoint was the mean difference in the coefficient of fat absorption (CFA-72h) between Enzepi and placebo treatment.
Maltese: Il-punt aħħari primarju tal-effikaċja kien id-differenza medja fil-koeffiċjent tal-assorbiment tax-xaħam (CFA-72h) bejn Enzepi u l-kura bil-plaċebo.
English: NAME OF THE MEDICINAL PRODUCT Enzepi 5,000 units gastro-resistant hard capsules Pancreas powder
Maltese: TAL-PRODOTT MEDIĊINALI Enzepi ta' 5,000 unità kapsuli ibsin gastro-reżistenti Trab pankreatiku
English: Enzepi 5,000 units gastro-resistant hard capsules One capsule contains 39.8 mg of pancreas powder including the following enzymatic activities: - lipolytic activity:
Maltese: Enzepi 5,000 unità kapsuli ibsin gastro-reżistenti Kapsula waħda fiha 39.8 mg ta' trab pankreatiku inkluż l-attivitajiet enzimatiċi li ġejjin: - attività lipolitika:
English: It is only in the duodenum, which has a different environment with a pH value greater than 5, that these digestive enzymes are released from the granules.
Maltese: Huwa biss fid-duwodenu, li għandu ambjent differenti b'valur pH aktar minn 5, li dawn l-enzimi diġestivi jiġu rilaxxati mill-granijiet.
English: STATEMENT OF ACTIVE SUBSTANCE(S) One capsule contains 83.7 mg of pancreas powder of porcine origin including the following enzymatic activities: lipolytic activity:
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I) Kapsula waħda fiha 83.7 mg trab pankreatiku li ġej mill-ħnieżer inkluż l-attivitajiet enzimatiċi li ġejjin: attività lipolitika:
English: The Enzepi 25,000 units gastro-resistant hard capsule has a green opaque cap and a white opaque body with ‘Enzepi 25' printed on it and contains light-brown gastro-resistant granules.
Maltese: Il-kapsula iebsa gastro-reżistenti Enzepi 25,000 unità għandha kappa opaka ħadra u korp opak abjad b'‘Enzepi 25' stampata u fiha granijiet gastro-reżistenti kannella ċari.
English: units amylolytic activity:
Maltese: attività amilolitika:
English: STATEMENT OF ACTIVE SUBSTANCE(S) One capsule contains 209.3 mg of pancreas powder of porcine origin including the following enzymatic activities: lipolytic activity:
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I) Kapsula waħda fiha 209.3 mg trab pankreatiku li ġej mill-ħnieżer inkluż l-attivitajiet enzimatiċi li ġejjin: attività lipolitika:
English: The short-term efficacy and safety of Enzepi were assessed in clinical studies in paediatric patients, ages 1 to 17 years, with EPI due to CF.
Maltese: L-effikaċja u sigurtà fuq żmien qasir ta' Enzepi kienu vvalutati fi studji kliniċi f'pazjenti pedjatriċi, fl-etajiet ta' sena sa 17-il sena, bl-EPI minħabba CF.
English: Maximum recommended dose
Maltese: Doża massima rakkomandata
English: Enzepi belongs to the family of pancreatic enzyme products and contains a defined amount of lipase, amylase and protease that have been extracted from porcine pancreas and purified using a process designed to inactivate viruses.
Maltese: Enzepi hu parti mill-familja ta' prodotti tal-enzimi pankreatiċi u għandu ammont definit ta' lipażi, amilażi u protease li ġew estratti mill-frixa tal-ħnieżer u ppurifikati permezz ta' proċess imfassal biex jinattiva lvirusijiet.
English: Caution must be exercised when prescribing Enzepi to patients with a history of gout, renal impairment, or hyperuricaemia.
Maltese: Għandha tingħata attenzjoni meta jingħata Enzepi lil pazjenti bi storja ta' gotta, indeboliment renali, jew iperurikemija.
English: Study PR-011 was an open-label crossover study in 15 patients, ages 1 to 11 months, with EPI due to CF.
Maltese: Studju PR-011 kien studju inkroċjat bit-tikketta mikxufa li sar fuq 15-il pazjent ta' bejn xahar u 11-il xahar, bl-EPI minħabba CF.
English: EU/1/16/1113/005 20 gastro-resistant hard capsules EU/1/16/1113/006 50 gastro-resistant hard capsules EU/1/16/1113/007 100 gastro-resistant hard capsules EU/1/16/1113/008 200 gastro-resistant hard capsules
Maltese: EU/1/16/1113/005 20 kapsula iebsa gastro-reżistenti EU/1/16/1113/006 50 kapsula iebsa gastro-reżistenti EU/1/16/1113/007 100 kapsula iebsa gastro-reżistenti EU/1/16/1113/008 200 kapsula iebsa gastro-reżistenti
English: NAME OF THE MEDICINAL PRODUCT Enzepi 10,000 units gastro-resistant hard capsules Pancreas powder
Maltese: TAL-PRODOTT MEDIĊINALI Enzepi ta' 10,000 unità kapsuli ibsin gastro-reżistenti Trab pankreatiku
English: EU/1/16/1113/013 20 gastro-resistant hard capsules EU/1/16/1113/014 50 gastro-resistant hard capsules EU/1/16/1113/015 100 gastro-resistant hard capsules EU/1/16/1113/016 200 gastro-resistant hard capsules
Maltese: EU/1/16/1113/013 20 kapsula iebsa gastro-reżistenti EU/1/16/1113/014 50 kapsula iebsa gastro-reżistenti EU/1/16/1113/015 100 kapsula iebsa gastro-reżistenti EU/1/16/1113/016 200 kapsula iebsa gastro-reżistenti
English: Paediatric population between 1 and less than 4 years of age For children between 1 and less than 4 years of age the recommended starting dose is 1,000 lipase units/kg of body weight per meal.
Maltese: Popolazzjoni pedjatrika fl-età ta' bejn sena u inqas minn 4 snin Għal tfal fl-età ta' bejn sena u inqas minn 4 snin id-doża tal-bidu rakkomandata hija ta' 1,000 unità ta' lipażi/kg tal-piż tal-ġisem għal kull ikla.
English: Consideration should be given to blood glucose monitoring in patients at risk of abnormal blood glucose levels as glycaemic control may be affected by administration of pancreatic enzyme replacement therapy (see section 4.8).
Maltese: Għandha tingħata kunsiderazzjoni għall-monitoraġġ tal-glukożju fid-demm f'pazjenti f'riskju ta' livelli anormali tal-glukożju fid-demm peress li l-kontroll gliċemiku jista' jkun affetwat permezz talamministrazzjoni ta' terapija ta' sostituzzjoni tal-enzimi pankreatiċi (ara sezzjoni 4.8).
English: Hard capsule with a blue opaque cap and a white opaque body, printed with “Enzepi 40” and containing light-brown gastro-resistant granules.
Maltese: Kapsula iebsa b'kappa opaka blu u korp opak abjad, stampata b'“Enzepi 40” u li fiha granijiet gastroreżistenti kannella ċari.
English: The dose is measured in ‘lipase units'.
Maltese: Id-doża hija mkejla f'‘unitajiet ta' lipażi'.
English: Rash generalised Rash
Maltese: Raxx ġeneralizzat
English: STATEMENT OF ACTIVE SUBSTANCE(S) One capsule contains 39.8 mg of pancreas powder of porcine origin including the following enzymatic activities: lipolytic activity:
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I) Kapsula waħda fiha 39.8 mg ta' trab pankreatiku li ġej mill-ħnieżer inkluż l-attivitajiet enzimatiċi li ġejjin: attività lipolitika:
English: The CFA-72h was determined by a 72-hour stool collection during both treatments, when both fat excretion and fat ingestion were measured.
Maltese: Is-CFA-72h kien determinat b'ġabra tal-ippurgar ta' 72 siegħa waqt iż-żewġ kuri, fejn tkejlu kemm l-eskrezzjoni tax-xaħam kif ukoll l-inġestjoni tax-xaħam.
English: The Enzepi 5,000 units gastro-resistant hard capsule has a white opaque cap and a white opaque body with ‘Enzepi 5' printed on it and contains light-brown gastro-resistant granules.
Maltese: Il-kapsula iebsa gastro-reżistenti Enzepi 5000 unità għandha kappa opaka bajda u korp opak abjad b'‘Enzepi 5' stampata u fiha granijiet gastro-reżistenti kannella ċari.
English: Enzepi can only be sprinkled on certain food (see section 3).
Maltese: Enzepi jista' jitraxxax fuq ċerta ikel biss (ara sezzjoni 3).
English: EU/1/16/1113/009 20 gastro-resistant hard capsules EU/1/16/1113/010 50 gastro-resistant hard capsules EU/1/16/1113/011 100 gastro-resistant hard capsules EU/1/16/1113/012 200 gastro-resistant hard capsules
Maltese: EU/1/16/1113/009 20 kapsula iebsa gastro-reżistenti EU/1/16/1113/010 50 kapsula iebsa gastro-reżistenti EU/1/16/1113/011 100 kapsula iebsa gastro-reżistenti EU/1/16/1113/012 200 kapsula iebsa gastro-reżistenti
English: The Enzepi 10,000 units gastro-resistant hard capsule has a yellow opaque cap and a white opaque body with ‘Enzepi 10' printed on it and contains light-brown gastro-resistant granules.
Maltese: Il-kapsula iebsa gastro-reżistenti Enzepi 10,000 unità għandha kappa opaka safra u korp opak abjad b'‘Enzepi 10' stampata u fiha granijiet gastro-reżistenti kannella ċari.
English: STATEMENT OF ACTIVE SUBSTANCE(S) One capsule contains 334.9 mg of pancreas powder of porcine origin including the following enzymatic activities: lipolytic activity:
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I) Kapsula waħda fiha 334.9 mg ta' trab pankreatiku li ġej mill-ħnieżer inkluż l-attivitajiet enzimatiċi li ġejjin: attività lipolitika:
English: If you have cystic fibrosis and you are taking pancreatic enzymes exceeding10,000 lipase units per kilogram body weight per day and have unusual abdominal symptoms (such as severe stomach pain, trouble passing stools, nausea or vomiting) or changes in abdominal symptoms, tell your doctor straightaway.
Maltese: Jekk għandek il-fibrożi ċistika u qed tieħu l-enzimi pankreatiċi li jaqbżu 10,000 unità ta' lipażi għal kull kilogramma tal-piż tal-ġisem kuljum u għandek sintomi addominali mhux tas-soltu (bħal uġigħ sever fl-istonku, problemi biex tipporga, dardir jew rimettar) jew bidliet fis-sintomi addominali, kellem lit-tabib tiegħek minnufih.
English: EU/1/16/1113/001 20 gastro-resistant hard capsules EU/1/16/1113/002 50 gastro-resistant hard capsules EU/1/16/1113/003 100 gastro-resistant hard capsules EU/1/16/1113/004 200 gastro-resistant hard capsules
Maltese: EU/1/16/1113/001 20 kapsula iebsa gastro-reżistenti EU/1/16/1113/002 50 kapsula iebsa gastro-reżistenti EU/1/16/1113/003 100 kapsula iebsa gastro-reżistenti EU/1/16/1113/004 200 kapsula iebsa gastro-reżistenti
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - 40,000 unit strength
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ IL-PAKKETT TA' BARRA KARTUNA TA' BARRA - 40,000 unità tal-qawwa
English: Strictures of the ileo-caecum and large bowel (fibrosing colonopathy) have been reported in patients with cystic fibrosis taking high doses of pancreatin preparations.
Maltese: Aqra sew dan il-fuljett kollu qabel tibda tieħu din il-mediċina peress li fih informazzjoni importanti għalik.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation:
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni:
English: Swelling face Urticaria
Maltese: Twissijiet u prekawzjonijiet
English: Your total daily dose should not exceed 2,500 lipase units per kg of body weight per meal (or 10,000 lipase units per kg of body weight per day).
Maltese: Id-doża totali ta' kuljum tiegħek m'għandhiex taqbeż 2,500 unità ta' lipażi għal kull kg tal-piż tal-ġisem għal kull ikla (jew 10,000 unità ta' lipażi għal kull kg tal-piż tal-ġisem kuljum).
English: Abnormal blood glucose levels
Maltese: GĦAMLA KWALITATTIVA
English: The contents of the capsule should not be mixed directly into formula or breast-milk as this may diminish efficacy.
Maltese: Il-kontenut tal-kapsula ma għandux jiġi mħallat direttament mal-ħalib formula jew mal-ħalib tas-sider minħabba li tista' titnaqqas l-effikaċja.
English: Enzepi 40,000 units: hypromellose, carrageenan (E407), potassium chloride, titanium dioxide E171, carnauba wax, water, indigotine (E132).
Maltese: Enzepi 40,000 unità: hypromellose, carrageenan (E407), potassium chloride, titanium dioxide (E171), carnauba wax, water, indigotine (E132). o Linka tal-istampar: shellac, propylene glycol, indigotine (E132).
English: High doses of pancreatic enzyme products have been associated with hyperuricosuria and hyperuricaemia, and should be used with caution in patients with a history of gout, renal impairment or hyperuricaemia (see section 4.4).
Maltese: Dożi għoljin ta' prodotti tal-enzimi pankreatiċi ġew assoċjati mal-iperurikosurja u l-iperurikemija u għandhom jintużaw b'kawtela f'pazjenti bi storja ta' gotta, indeboliment renali, jew iperurikemija (ara sezzjoni 4.4).
English: Anaphylactic shock is a severe, potentially life-threatening allergic reaction that can develop rapidly.
Maltese: Ix-xokk anafilattiku huwa reazzjoni allerġika severa, potenzjalment fatali li tista' tiżviluppa malajr.
English: An updated RMP should be submitted: At the request of the European Medicines Agency; Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Maltese: Kull meta s-sistema tal-ġestjoni tar-riskju tiġi modifikata speċjalment minħabba li tasal informazzjoni ġdida li tista' twassal għal bidla sinifikanti fil-profil bejn il-benefiċċju u r-riskju jew minħabba li jintlaħaq għan importanti (farmakoviġilanza jew minimizzazzjoni tar-riskji).
English: After first opening, the medicine may be stored for a maximum of 6 months below 25°C in its tightly closed container.
Maltese: Wara l-ewwel ftuħ, il-mediċina tista' tinħażen għal massimu ta' 6 xhur taħt 25°C fil-kontenitur magħluq sew tiegħu.
English: For storage conditions after first opening of the medicinal product, see section 6.3.
Maltese: Għall-kondizzjonijiet ta' ħażna wara l-ewwel ftuħ tal-prodott mediċinali, ara sezzjoni 6.3. 6.5
English: A rare bowel condition called ‘fibrosing colonopathy', where the intestine is narrowed, has been reported in patients with cystic fibrosis taking high doses of pancreatic enzymes.
Maltese: Pazjenti b'fibrożi ċistika Kondizzjoni rari tal-musrana li tissejjaħ ‘kolonopatija fibrosizzanti', fejn il-musrana tidjieq, ġiet rapportata f'pazjenti b'fibrożi ċistika li jieħdu dożi għoljin ta' enzimi pankreatiċi.
English: Common (may affect up to 1 in 10 people): abdominal discomfort or bloating flatulence/passing wind diarrhoea headache.
Maltese: Komuni (li jistgħu jaffettwaw sa persuna 1 minn kull 10): skumdità jew nefħa addominali gass dijarea uġigħ ta' ras.
English: Care should be taken to ensure that Enzepi is not crushed or chewed or retained in the mouth, to avoid irritation of the oral mucosa.
Maltese: Għandu jiġi żgurat li Enzepi ma jiġix mitħun jew mimgħud jew jibqa' fil-ħalq, sabiex tiġi evitata l-irritazzjoni tal-mukoża orali.
English: Enzepi contains a mixture of natural digestive enzymes which are used to digest food.
Maltese: Enzepi għandu taħlita ta' enzimi diġestivi naturali li jintużaw sabiex jiddiġestixxu l-ikel.
English: The recommended starting dose for children between 1 and 4 years of age is 1,000 lipase units per kg of body weight with each meal.
Maltese: Id-doża tal-bidu rakkomandata fi tfal fl-età ta' bejn sena u 4 snin hija ta' 1,000 unità ta' lipażi għal kull kg talpiż tal-ġisem ma' kull ikla.
English: There was no wash-out period.
Maltese: Ma kien hemm l-ebda perjodu ta' washout.
English: Bioequivalence was demonstrated with regard to the primary pharmacokinetic parameters, i.e. AUC and Cmax, in the study with the 150 mg tablet, as the 90% CIs were within the required 80-125% limits.
Maltese: Bijoekwivalenza ntweriet fir-rigward tal-parametri farmakokinetiċi ewlenin, jiġifieri AUC u Cmax, flistudju bil-pillola ta' 150 mg, peress li s-CIs ta' 90 % kienu fi ħdan il-limiti ta' 80-125 % meħtieġa.
English: The active substance of Merisone is tolperisone hydrochloride, which is a centrally acting muscle relaxant indicated for the symptomatic treatment of post-stroke spasticity in adults.
Maltese: Is-sustanza attiva ta' Merisone hija idroklorur tat-tolperison li hija rilassant tal-muskoli b'azzjoni ċentrali indikat għal kura sintomatika ta' spastiċità fl-adulti wara puplesija.