FrancophonIA/ELRC3.0 huggingface dataset:
English: Meetings of GMDP6, GCP, GLP and Pharmacovigilance Inspectors working groups, and of the Joint CHMP/CVMP Quality Working Party
Maltese: tkomplija tat-titjib tal-monitoraġġ tas-sigurtà għall-mediċini għal użu mill-bniedem kif ukoll veterinarju;
English: His areas of expertise include: quality and safety of biological medicines, including ATMPs; clinical trials and risk-mitigation strategies for first-in-man clinical trials; non-clinical development of biotechnology-derived medicinal products; unwanted immunogenicity of therapeutic proteins; concepts for comparability exercise for biotechnological medicinal products.
Maltese: L-Aġenzija qiegħda tesperjenza żieda kontinwa fil-volum ta' xogħol f'varji oqsma talattivitajiet tagħha, fosthom il-konsulenza xjentifika, il-mediċini għal użu pedjatriku, lawtorizzazzjoni ta' vaċċini kontra epidemiji ta' annimali, it-trasparenza u l-impenji internazzjonali, biex insemmu xi ftit eżempji.
English: Community herbal monograph on Curcumae longae rhizoma
Maltese: Il-monitoraġġ tas-sigurtà ta' mediċini huwa qasam kostantement mifli, żviluppat u msaħħaħ.
English: Documents on improved working practices, document management and communication tools, also regarding the interactions and co-operation CHMP-PhVWP, HMPC-PhVWP, PDCO-PhVWP, CMD(h)-PhVWP and HMA-h-PhVWP
Maltese: L-ewwel nett, l-Aġenzija se tikkollabora mal-partijiet interessati għall-promozzjoni u l-iffaċilitar tal-awtorizzazzjoni permezz tal-proċedura ċentralizzata tal-vaċċini kontra mard epizootiku maġġuri tal-annimali, partikolarment l-influwenza tat-tjur, il-bluetongue u l-marda tal-ilsien u d-dwiefer.
English: CHMP/CVMP Guideline on Active Substance Master Fileintroduction of an Annex for Herbal Medicinal Products, on referral by the HMPC
Maltese: Matul dan in-numru ta' snin, l-Aġenzija implimentat varji partijiet ġodda tal-leġiżlazzjoni farmaċewtika.
English: ATCvet code: QI01AN01.
Maltese: Kodiċi ATC veterinarja QI01AN01.
English: Carretera de Susqueda Amer
Maltese: Carretera de Susqueda
English: 10,000 doses
Maltese: 10,000 doża
English: EVANT (vaccine):
Maltese: EVANT (vaċċin):
English: 1,000 doses 5,000 doses
Maltese: 1,000 doża 5,000 doża
English: HIPRA SLOVENSKO, s.r.o.
Maltese: Česká republika HIPRA SLOVENSKO, s.r.o.
English: Eimeria acervulina, strain 003 ..................................... 332 - 450* Eimeria maxima, strain 013 ......................................... 196 - 265* Eimeria mitis, strain 006 .............................................. 293 - 397* Eimeria praecox, strain 007 ......................................... 293 - 397* Eimeria tenella, strain 004 ........................................... 276 - 374*
Maltese: 332 - 450* Eimeria maxima, strejn 013 ...................................... 196 - 265* Eimeria mitis, strejn 006........................................... 293 - 397* Eimeria praecox, strejn 007 ...................................... 293 - 397* Eimeria tenella, strejn 004 ........................................ 276 - 374*
English: LABORATORIOS HIPRA, S.A. Carretera C-63, Km 48.300 Polígono Industrial El Rieral Amer
Maltese: LABORATORIOS HIPRA, S.A. Carretera C-63, Km 48.300
English: Eimeria acervulina, strain 003 ....................................... 332 - 450 Eimeria maxima, strain 013 ........................................... 196 - 265 Eimeria mitis, strain 006 ................................................ 293 - 397 Eimeria praecox, strain 007 ........................................... 293 - 397 Eimeria tenella, strain 004 ............................................. 276 - 374
Maltese: 332 - 450 Eimeria maxima, strejn 013 ........................................ 196 - 265 Eimeria mitis, strejn 006............................................. 293 - 397 Eimeria praecox, strejn 007 ........................................ 293 - 397 Eimeria tenella, strejn 004 .......................................... 276 - 374
English: Suspension: White turbid suspension.
Maltese: Suspensjoni: Suspensjoni bajda mdardra.
English: Store and transport refrigerated (2 ºC - 8 ºC).
Maltese: Aħżen u ttrasporta ġo friġġ (2°C - 8°C).
English: 17170 Girona
Maltese: 17170 Girona SPANJA
English: 50 ml 250 ml 500 ml
Maltese: 250 mL 1,400 mL
English: HIPRAMUNE T (solvent): Brilliant blue (E 133) Red AC (E 129) Vanillin
Maltese: Brilliant blue (E 133) Red AC (E 129) Vanillin
English: Date of first authorisation: 05/02/2019
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI / TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 05/02/2019
English: Brilliant Blue (E133) Red AC (E129) Vanillin
Maltese: Ingredjenti oħra: Brilliant Blue (E133) Red AC (E129) Vanillin
English: Type I colourless glass vials containing 7 ml, 35 ml or 70 ml of suspension (1,000, 5,000 and 10,000 doses) closed with type I polymeric elastomer closures and aluminium caps.
Maltese: Kunjetti tal-ħġieġ bla kulur tat-tip I li fihom 7 mL, 35 mL jew 70 mL ta' suspensjoni (1,000, 5,000 u 10,000 doża) magħluqin b'tappijiet tal-elastomer polimeriku tat-tip I u għotjien tal-aluminju.
English: Onset of immunity: 14 days post-vaccination.
Maltese: Bidu tal-immunità: 14-il jum wara t-tilqima.
English: Polypropylene vials containing 50 ml, 250 ml or 500 ml of solvent closed with type I polymeric elastomer closures and aluminium caps.
Maltese: Kunjetti tal-polipropelin li fihom 50 mL, 250 mL u 500 mL ta' solvent magħluqin b'tappijiet talelastomer polimeriku tat-tip I u għotjien tal-aluminju.
English: The method of administration is by coarse spray by using a suitable device (volume delivered: 28 ml/100 chicks, droplet size: 200 - 250 µm and working pressure: 1.5 to 3 bars).
Maltese: Il-metodu ta' amministrazzjoni huwa permezz ta' bexx oħxon billi jintuża strument xieraq (volum mogħti: 28 mL/100 fellus, daqs tal-qtajra: 200 - 250 µm u pressjoni ta' ħidma: 1.5 sa 3 bars).
English: Brilliant Blue (E133) Red AC (E129)
Maltese: Brilliant Blue (E133)
English: Each dose (0.007 ml) of undiluted vaccine contains: EVANT:
Maltese: Kull doża (0.007 mL) tal-vaċċin mhux dilwit fiha: EVANT:
English: Solvent: Dark brownish solution.
Maltese: Solvent: Soluzzjoni ta' lewn kannella skur.
English: One vial of 35 ml (5,000 doses) of EVANT and one vial of 250 ml of HIPRAMUNE T (solvent).
Maltese: Kunjett wieħed ta' 35 mL (5,000 doża) ta' EVANT u kunjett wieħed ta' 250 mL ta' HIPRAMUNE T (solvent).
English: One dose of vaccine (0.007 ml) from 1 day of age.
Maltese: Doża waħda tal-vaċċin (0.007 mL) mill-età ta' ġurnata.
English: Suspension for oral spray.
Maltese: Suspensjoni għal bexx orali.
English: For the active immunisation of chicks from 1 day of age to reduce intestinal lesions and oocysts output associated with coccidiosis caused by Eimeria acervulina, Eimeria maxima, Eimeria mitis, Eimeria praecox and Eimeria tenella and to reduce clinical signs (diarrhoea) associated with Eimeria acervulina, Eimeria maxima and Eimeria tenella.
Maltese: Għall-immunizzazzjoni attiva ta' flieles minn età ta' ġurnata biex jitnaqqas l-iżvilupp ta' leżjonijiet u uċisti intestinali assoċjat ma' koċċidjożi kkawżata minn Eimeria acervulina, Eimeria maxima, Eimeria mitis, Eimeria praecox u Eimeria tenella u biex jitnaqqsu s-sinjali kliniċi (dijarea) assoċjati ma'
English: Coarse spray
Maltese: TWISSIJIET SPEĊJALI
English: The excipients (including adjuvants) listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Maltese: L-addittivi (inkluż l-aġġuvanti) elenkati f‘sezzjoni 6.1 tal-Karatteristiċi tal-Prodott fil-Qosor huma sustanzi ammissibbli li għalihom m'hemmx bżonn ta' limiti massimi ta' residwi kif indikat fit-tabella numru 1 tal-anness tar-Regolament tal-Kummissjoni (UE) Nru 37/2010 huma kkunsidrati li ma jaqgħux fi ħdan l-iskop tar-Regolament (KE) Nru 470/2009 meta użati bħal f'dan il-prodott mediċinali veterinarju.
English: One vial of 70 ml (10,000 doses) of EVANT and one vial of 500 ml of HIPRAMUNE T (solvent).
Maltese: Kunjett wieħed ta' 70 mL (10,000 doża) ta' EVANT u kunjett wieħed ta' 500 mL ta' HIPRAMUNE T (solvent).
English: Administration:
Maltese: TAMMINISTRA
English: Dilute the vaccine with the relevant volumes of the solvent (HIPRAMUNE T) and water, as shown in the following table:
Maltese: Iddilwi l-vaċċin bil-volumi rilevanti tas-solvent (HIPRAMUNE T) u bl-ilma, kif jidhru fit-tabella li ġejja:
English: Marketing authorisation holder and manufacturer responsible for batch release: LABORATORIOS HIPRA, S.A.
Maltese: Ре публика България LABORATORIOS HIPRA, S.A.
English: For the active immunisation of chicks from 1 day of age to reduce intestinal lesions and oocysts output associated with coccidiosis caused by Eimeria acervulina, Eimeria maxima, Eimeria mitis,
Maltese: Biex jistimula immunità attiva kontra koċċidjożi kkawżata minn Eimeria acervulina, Eimeria maxima,
English: The active substances being principles of biological origin intended to produce active immunity are not within the scope of Regulation (EC) No 470/2009.
Maltese: Is-sustanza attiva li hija prinċipju ta' oriġini bijoloġika maħsuba sabiex tipproduċi immunità attiva ma taqax fi ħdan l-iskop tar-Regolament (KE) Nru 470/2009.
English: To stimulate active immunity against coccidiosis caused by Eimeria acervulina, Eimeria maxima, Eimeria mitis, Eimeria praecox and Eimeria tenella.
Maltese: Eimeria acervulina, Eimeria maxima u Eimeria tenella.
English: MINIMUM PARTICULARS TO APPEAR ON IMMEDIATE PACKAGING Solvent vial of 50 ml, 250 ml or 500 ml
Maltese: Kunjett tas-solvent ta' 50 mL, 250 mL jew 500 mL
English: One vial of 7 ml (1,000 doses) of EVANT and one vial of 50 ml of HIPRAMUNE T (solvent).
Maltese: Kunjett wieħed ta' 7 mL (1,000 doża) ta' EVANT u kunjett wieħed ta' 50 mL ta' HIPRAMUNE T (solvent).
English: HIPRAMUNE T (solvent): Shelf life of the veterinary medicinal product as packaged for sale: 2 years.
Maltese: Żmien kemm idum tajjeb l-prodott mediċinali veterinarju kif ippakkjat għall-bejgħ: 10 xhur.
English: Cardboard box with one vial of EVANT containing 35 ml (5,000 doses) and one vial of HIPRAMUNE T containing 250 ml.
Maltese: Kaxxa tal-kartun b'kunjett wieħed ta' EVANT li fih 35 mL (5,000 doża) u kunjett wieħed ta' HIPRAMUNE T li fih 250 mL.
English: Major incompatibilities:
Maltese: Inkompatibilita jiet:
English: Before starting to prepare the spray solution, ensure there is a clean container with sufficient capacity for preparing the diluted vaccine suspension available.
Maltese: Qabel ma tibda tipprepara s-soluzzjoni tal-bexx, kun żgur li hemm kontenitur nadif disponibbli b'kapaċità suffiċjenti biex tipprepara s-suspensjoni dilwita tal-vaċċin.
English: Duration of immunity: 63 days post-vaccination in an environment that permits oocysts recycling.
Maltese: Perjodu tal-immunità: 63 ġurnata wara t-tilqima f'ambjent li jippermetti r-riċiklaġġ tal-uċisti.
English: Cardboard box with one vial of EVANT containing 70 ml (10,000 doses) and one vial of HIPRAMUNE T containing 500 ml.
Maltese: Kaxxa tal-kartun b'kunjett wieħed ta' EVANT li fih 70 mL (10,000 doża) u kunjett wieħed ta' HIPRAMUNE T li fih 500 mL.
English: Shelf life after dilution according to directions: 10 hours.
Maltese: Ladarba jiġi dilwit, uża fi żmien 10 sigħat.
English: Eimeria praecox and Eimeria tenella and to reduce clinical signs (diarrhoea) associated with Eimeria acervulina, Eimeria maxima and Eimeria tenella.
Maltese: Informazzjoni dettaljata dwar dan il-prodott tinstab fuq il-websajt tal-Aġenzija Ewropea dwar il-Mediċini http://www.ema.europa.eu/.
English: DOSES
Maltese: KWANTITÀ
English: Do not mix with any other veterinary medicinal product, except the solvent supplied for use with the veterinary medicinal product.
Maltese: Tħallatx ma ebda prodott mediċinali veterinarju ieħor, ħlief mas-solvent ipprovdut għal użu ma' dan il-prodott mediċinali veterinarju.
English: Cardboard box with one vial of EVANT containing 7 ml (1,000 doses) and one vial of HIPRAMUNE T containing 50 ml.
Maltese: Kaxxa tal-kartun b'kunjett wieħed ta' EVANT li fih 7 mL (1,000 doża) u kunjett wieħed ta' HIPRAMUNE T li fih 50 mL.
English: Purified water
Maltese: TAL-PRODOTT MEDIĊINALI
English: Shake the solvent vial (HIPRAMUNE T).
Maltese: Ħawwad il-kunjett tas-solvent (HIPRAMUNE T).
English: • oral contraceptives,
Maltese: • kontraċettivi orali,
English: Patheon France 40 boulevard de champaret 38300 Bourgoin-Jallieu France
Maltese: Patheon France 40 boulevard de champaret 38300 Bourgoin-Jallieu Franza
English: Shellac (E904)
Maltese: Shellac Glaze (E904)
English: DATE OF FIRST AUTHORISATION 20 November 2015
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI 20 Novembru, 2015
English: 90 capsules.
Maltese: 90 kapsula.
English: For additional information, see section 6.6.
Maltese: Għal aktar informazzjoni, ara sezzjoni 6.6.
English: • oestrogen,
Maltese: • estroġenu,
English: MARKETING AUTHORISATION HOLDER Retrophin Europe Limited, Palmerston House, Fenian Street Dublin 2, Ireland
Maltese: Retrophin Europe Limited, Palmerston House, Fenian Street Dublin 2, Irlanda
English: Dublin 2, Ireland Tel: +353 86 803 8014 info@retrophin.com
Maltese: Retrophin Europe Limited Palmerston House Fenian Street Dublin 2, Irlanda Tel: +353 86 803 8014 info@retrophin.com
English: MARKETING AUTHORISATION NUMBER EU/1/13/895/002
Maltese: EU/1/13/895/002
English: • AMACR deficiency (n=1)
Maltese: • Defiċjenza ta' AMACR (n=1)
English: • CYP7A1 deficiency
Maltese: • Defiċjenza ta' CYP7A1
English: MARKETING AUTHORISATION NUMBER EU/1/13/895/001
Maltese: EU/1/13/895/001
English: INFORMATION IN BRAILLE Kolbam 50 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Kolbam 50 mg
English: INFORMATION IN BRAILLE Kolbam 250 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Kolbam 250 mg
English: There are several enzyme defects described in the literature.
Maltese: Hemm diversi difetti fl-enzimi deskritti fil-letteratura.
English: • CYP7A1 deficiency (n=1)
Maltese: • Defiċjenza ta' CYP7A1 (n=1)
English: Propylene Glycol (E1520) Strong Ammonia Solution (E527) Potassium Hydroxide (E525) Black Iron Oxide (E172)
Maltese: Propylene Glycol (E1520) Strong Ammonia Solution (E527) Potassium Hydroxide (E525) Iron Oxide iswed (E172)
English: Preferred Term Frequency
Maltese: Terminu Ppreferut Frekwenza
English: Adverse reactions are ranked according to system organ class, using the following convention: very common (≥ 1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to
Maltese: Ir-reazzjonijiet avversi huma kklassifikati skont is-sistema tal-klassifika tal-organi, bl-użu tal konvenzjoni li ġejja: 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-dejta disponibbli).
English: Pack sizes: 90 capsules.
Maltese: Daqsijiet tal-pakkett: 90 kapsula.
English: A total of 85 patients took part in the clinical study.
Maltese: Fl-istudju kliniku ħadu sehem total ta' 85 pazjent.
English: In all studies, a dose of 10-15 mg/kg/day was administered.
Maltese: Fl-istudji kollha, ingħatat doża ta' 10-15 mg/kg/kuljum.
English: Concomitant use with phenobarbital (see section 4.5).
Maltese: Użu konkomitanti ma' phenobarbital (ara sezzjoni 4.5).
English: • Sterol 27-hydroxylase deficiency (presenting as CTX; n=5)
Maltese: • Defiċjenza ta' sterol 27-hydroxylase (li tippreżenta bħala CTX; n=5)
English: • Sterol 27-hydroxylase deficiency (presenting as CTX)
Maltese: • Defiċjenza ta' sterol 27-hydroxylase (li tippreżenta bħala CTX)
English: The limited data from animal studies do not indicate direct reproductive toxicity (see section 5.3).
Maltese: Id-dejta limitata minn studji fuq l-annimali ma tindikax tossiċità riproduttiva diretta (ara sezzjoni 5.3).
English: Do not store above 30 °C.
Maltese: Taħżinx f'temperatura ta' aktar minn 30°C.
English: • Increase liver enzymes (serum transaminases)
Maltese: • żieda fl-enzimi tal-fwied (transaminażi fis-serum)
English: Of the 53 patients treated, 41 (77%) presented with disorders in primary bile acid synthesis including sterol 27-hydroxylase deficiency (presenting as CTX; n=8) and AMACR deficiency (n=1).
Maltese: Mit-53 pazjent ittrattat, 41 (77%) ippreżentaw b'disturbi fis-sintesi tal-aċidu biljari primarja inkluż defiċjenza ta' sterol 27-hydroxylase (li tippreżenta bħala CTX; n=8) u defiċjenza ta' AMACR (n=1).
English: Silicified microcrystalline cellulose
Maltese: Kontenut tal-kapsula Silicified microcrystalline cellulose Magnesium stearate
English: • AMACR deficiency
Maltese: • Defiċjenza ta' AMACR
English: In Study CAC-002-01, the mean age of patients at baseline was 9.0 years, with ages ranging from 0.1 to 35.6 years.
Maltese: Fl-Istudju CAC-002-01, l-età medja tal-pazjenti fil-linja bażi kienet ta 9.0 snin, b'etajiet li jvarjaw minn 0.1 sa 35.6 snin.
English: Of these 85 patients, 52 presented with disorders in primary bile acid synthesis including the following 3 single enzymes:
Maltese: Minn dawn il-85 pazjent, 52 ippreżentaw b'disturbi fis-sintesi tal-aċidu biljari primarju inkluż it-3 enzimi uniċi li ġejjin:
English: The study was completed on 31 July 2016.
Maltese: Lulju 2016.
English: • heartburn (gastric reflux)
Maltese: • ħruq ta' stonku (rifluss gastriku)
English: CTX), 2- (or α-) methylacyl-CoA racemase (AMACR) and Cholesterol 7α hydroxylase (CYP7A1) deficiencies.
Maltese: CoA racemase (AMACR) jew Kolesterol 7α-hydroxylase (CYP7A1).
English: Among the subgroup of patients with CTX (n=8), 3 transitioned from CAC-91-10-10 and were on cholic acid treatment at study start.
Maltese: Fost is-sottogrupp ta' pazjenti b'CTX (n=8), 3 qalbu minn CAC-91-10-10 u kienu fuq trattament ta'
English: Laboratory tests showed elevation of serum gamma glutamyltransferase (Gamma GT) transaminases and serum bile acid concentrations.
Maltese: Testijiet fil laboratorju wrew żieda fil-gamma glutamyltransferase (GammaGT) transaminażi fis-serum u fil konċentrazzjonijiet tal-aċidu biljari fis-serum.
English: The 50 mg capsules are orange (black imprint “ASK001” and “50mg”).
Maltese: Il-kapsuli ta' 50 mg huma oranġjo (marka sewda "ASK001" u "50mg").
English: Study CAC-91-10-10, (Investigation in the pathogenesis of liver disease in patients with inborn errors of bile acid metabolism) was conducted from 1992-2009 to evaluate the therapeutic efficacy and safety of cholic acid to treat patients with identified inborn errors of bile acid metabolism.
Maltese: L-istudju CAC-91-10-10, (Investigazzjoni tal-patoġenesi ta' mard tal-fwied f'pazjenti b'difetti konġeniti fil-metaboliżmu tal-aċidu biljari) sar mill-1992-2009 biex jevalwa l-effikaċja terapewtika u s-sigurtà tal-aċidu koliku fil-kura ta' pazjenti b'difetti konġeniti identifikati fil-metaboliżmu tal-aċidu biljari.
English: Inborn errors of primary bile acid synthesis involve congenital defects in the primary enzymes responsible for catalysing key reactions in the synthesis of cholic and chenodeoxycholic acids.
Maltese: Difetti konġeniti fis-sintesi primarja tal-aċidu biljari jinvolvu difetti konġenitali fl-enzimi primarji responsabbli għall-katalizzazzjoni ta' reazzjonijiet ewlenin fis-sintesi tal-aċidu koliku u l-aċidu chenodeoxycholic.
English: Pharmacotherapeutic group: Bile and liver therapy, bile acid preparations; ATC code: A05AA03
Maltese: Terapija tal-bili u tal-fwied, preparazzjonijiet bl-aċidu biljari; Kodiċi ATC:
English: Concurrent elevation of serum gamma glutamyltransferase (Gamma GT), alanine aminotransferase (ALT) and/or serum bile acids above normal levels may indicate overdose.
Maltese: Żidiet fl-istess ħin tal-gamma glutamyltransferase (Gamma GT) fis-serum, alanine aminotransferase (ALT) u/jew aċidi biljari fisserum 'il fuq mil-livelli normali jistgħu jindikaw doża eċċessiva.
English: Of the 41 patients described above that were treated in Study CAC-002-01, 13 patients discontinued, 8 due to AEs, 1 for lack/loss of efficacy, 1 was lost to follow-up, and 3 withdrew consent.
Maltese: Mill-41 pazjent deskritti fuq li kienu rċevew kura fl-Istudju CAC-002-01, 13-il patients waqfu, 8 minħabba AEs, 1 minħabba nuqqas/telf tal-effikaċja, 1 ma baqax jiġi segwit, u 3 irtiraw il-kunsens.
English: - The other ingredients are: Capsule content: Silicified microcrystalline cellulose Magnesium stearate Capsule shell: Gelatin Titanium dioxide (E171) Kolbam 50 mg also contains Red iron oxide (E172).
Maltese: Qoxra tal-kapsula: - Gelatin - Titanium dioxide (E171) Kolbam 50 mg fih ukoll Red iron oxide (E172).
English: • lipid-lowering medicines such as clofibrate
Maltese: • mediċini jbaxxu l-lipidi bħal clofibrate
English: Additional or more frequent investigations should be undertaken to monitor therapy during periods of fast growth, concomitant disease and pregnancy (see section 4.6).
Maltese: Għandhom isiru investigazzjonijiet addizzjonali jew aktar frekwenti biex it-terapija tiġi mmonitorjata matul perjodi ta' tkabbir mgħaġġel, mard konkomittanti u tqala (ara sezzjoni 4.6).
English: - If you are taking phenobarbital (a medicine used for epilepsy).
Maltese: - jekk qed tieħu phenobarbital (mediċina li tintuża għall-epilessija).
English: Kolbam is indicated for the treatment of inborn errors in primary bile acid synthesis due to Sterol 27hydroxylase (presenting as cerebrotendinous xanthomatosis, CTX) deficiency, 2- (or α-) methylacylCoA racemase (AMACR) deficiency or Cholesterol 7α-hydroxylase (CYP7A1) deficiency in infants, children and adolescents aged 1 month to 18 years and adults.
Maltese: Ir-reġistru sejjer jimmonitorja dejta li tkun qed takkumula dwar l-effikaċja u s sigurtà fil-kura ta' żbalji inerenti fis-sinteżi tal-aċidu biljari primarja fi trabi, tfal, adolexxenti u adulti dovuti għal defiċjenzi fi Sterol 27-hydroxylase (li jippreżenta ruħu bħala cerebrotendinous xanthomatosis, CTX), 2- (jew α-) methylacyl-CoA racemase (AMACR) u Cholesterol 7α-hydroxylase (CYP7A1).
English: • Slight tingling (pruritus)
Maltese: • sfurija tal-ġilda (suffejra)
English: This medicine has been authorised under ‘exceptional circumstances'.
Maltese: Dan il-prodott mediċinali kien awtorizzat taħt ‘ċirkostanzi ta' eċċezzjoni'.
English: The events were transitory and generally did not interfere with the therapy.
Maltese: L-avvenimenti kienu tranżitorji u ġeneralment ma interferewx mat-terapija.
English: Reflux esophagitis
Maltese: EFFIKAĊI TAL-PRODOTT MEDIĊINALI
English: Jaundice Increased serum transaminases Gallstones
Maltese: Żieda fit-transaminażi fis-serum
English: Familial hypertriglyceridaemia
Maltese: Ipertrigliċeridemija familjali
English: 250 mg capsule: Size number 0 capsule with a white cap (black imprint “ASK002”) and white body (black imprint “250mg”).
Maltese: Kapsula ta' 250 mg: Kapsula b'daqs numru 0 b'għatu u korp abjad (marka sewda "ASK002" u "250mg").
English: A total of 53 patients took part in the clinical study and received at least one dose of cholic acid; 22 (42%) were treatment naive, i.e., received their first dose of cholic acid during study CAC002-01.
Maltese: Total ta' 53 pazjent ħadu sehem fl-istudju kliniku u rċevew mill-inqas doża waħda ta' aċidu koliku; 22 (42%) qatt ma kienu ħadu trattament qabel, jiġifieri, irċivew l-ewwel doża ta' aċidu koliku waqt l istudju CAC-002-01.
English: Biliary bile alcohols and bile acids show remarkable structural diversity across animal species.
Maltese: alkoħol tal-bili biljari u l-aċidi biljari juru diversità strutturali notevoli fost l-ispeċi tal-annimali.
English: Packs containing 90 capsules.
Maltese: Kapsula iebsa 90 kapsula.
English: Drug interactions with cholic acid mainly relate to medicinal products capable of interrupting the enterohepatic circulation of bile acids, such as the sequestering agents cholestyramine, colestipol, or colesevelam.
Maltese: L-interazzjonijiet tal-aċidu koliku ma' mediċini oħra huma prinċipalment relatati ma' prodotti mediċinali li kapaċi jinterrompu ċ-ċirkulazzjoni enteroepatika tal-aċidi biljari, bħall-aġenti sekwestranti cholestyramine, colestipol, jew colesevelam.
English: In the liver, cholic acid is extracted from portal blood by multiple mechanisms, including passive diffusion and transporters.
Maltese: Fil-fwied, l-aċidu koliku jiġi estratt mid-demm portali permezz ta' bosta mekkaniżmi, inkluż diffużjoni passiva u trasportaturi.