FrancophonIA/ELRC3.0 huggingface dataset:
English: Of these 24 patients, 23 had a diagnosis of CAH and 1 had a diagnosis of hypopituitarism including hypothyroidism.
Maltese: Minn dawn l-24 pazjent, 23 instab li kellhom CAH u 1 instab li kellu ipopitwitariżmu li jinkludi ipotirojdiżmu (hypothyroidism).
English: Alkindi 1 mg granules in capsules for opening:
Maltese: Alkindi 1 mg granijiet f'kapsuli għall-ftuħ:
English: Breast-feeding Hydrocortisone for replacement therapy can be used during breast-feeding.
Maltese: Tqala Hydrocortisone jista' jintuża waqt tqala għal terapija ta' sostituzzjoni.
English: - Alkindi 5 mg granules in capsules for opening: the capsule is printed with "INF-5.0" in grey ink.
Maltese: - Granijiet Alkindi ta' 5 mg f'kapsuli għall-ftuħ: il-kapsula hija stampata bil-kitba "INF-5.0"
English: Changing from conventional oral glucocorticoid treatment to Alkindi When changing patients from conventional oral hydrocortisone replacement therapy to Alkindi, an identical total daily dose may be given.
Maltese: Bidla minn kura konvenzjonali bil-glukokortikojdi ill-ħalq għal Alkindi Meta l-pazjenti jkunu qed jinqalbu minn terapija ta' sostituzzjoni konvenzjonali b'hydrocortisone mill-ħalq għal Alkindi, tista' tingħata l-istess doża totali ta' kuljum.
English: Alkindi 2 mg granules in capsules for opening:
Maltese: Alkindi 2 mg granijiet f'kapsuli għall-ftuħ:
English: Hydrocortisone is believed to be the principal corticosteroid secreted by the adrenal cortex.
Maltese: Hydrocortisone huwa maħsub li hu l-kortikosterojd prinċipali li joħroġ mill-kortiċi adrenali (adrenal cortex).
English: Alkindi 5 mg granules in capsules for opening:
Maltese: Alkindi 5 mg granijiet f'kapsuli għall-ftuħ:
English: Nasogastric tube feeding Alkindi granules are not suitable for nasogastric administration as they may cause tube blockage.
Maltese: Alkindi granijiet mhumiex adattati għall-amministrazzjoni nażogastrika għax jistgħu jimblokkaw it tubu.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON 2 MG CAPSULES
Maltese: KARTUNA 2 MG KAPSULI
English: Alkindi 2 mg granules in capsules for opening Each capsule contains 2 mg hydrocortisone
Maltese: Alkindi 2 mg granijiet f'kapsuli għall-ftuħ hydrocortisone
English: Alkindi 0.5 mg granules in capsules for opening Each capsule contains 0.5 mg hydrocortisone
Maltese: Alkindi 0.5 mg granijiet f'kapsuli għall-ftuħ hydrocortisone
English: Gastritis Nausea
Maltese: Gastrite Nawsja
English: For children who are able to take soft food, the granules may be sprinkled onto a spoonful of cold or room temperature soft food (such as yoghurt or fruit puree) and given immediately.
Maltese: JEW għat-tfal li jistgħu jieħdu ikel artab, xerred il-granuli fuq mgħarfa mimlija ikel artab ta' temperatura kiesħa jew temperatura ambjentali (bħal jogurt jew purè tal-frott) u agħti immedjatament
English: Alkindi 1 mg granules in capsules for opening hydrocortisone
Maltese: Alkindi 1 mg granijiet f'kapsuli għall-ftuħ hydrocortisone
English: Cortisol is made naturally by the adrenal glands in the body.
Maltese: Cortisol huwa magħmul b'mod naturali fil ġisem mill-glandoli adrenali.
English: Alkindi 0.5 mg granules in capsules for opening:
Maltese: Alkindi 0.5 mg granijiet f'kapsuli għall-ftuħ:
English: - being fed through a nasogastric tube.
Maltese: - qed jintema'/tintema' minn tubu nażogastriku.
English: Excessive weight gain with decreased height velocity or other symptoms or signs of Cushing syndrome indicate excessive glucocorticoid replacement.
Maltese: Żieda eċċessiva fil-piż flimkien ma' tnaqqis fil-veloċità tat-tul jew sintomi oħrajn jew sinjali ta' sindromu Cushing jindikaw sostituzzjoni eċċessiva ta' glukokortikojd.
English: Alkindi 5 mg granules in capsules for opening Each capsule contains 5 mg hydrocortisone
Maltese: Alkindi 5 mg granijiet f'kapsuli għall-ftuħ hydrocortisone
English: In addition they modify the body's immune responses to diverse stimuli.
Maltese: Barra minn hekk jimmodifikaw ir-rispons immunitarju tal-ġisem għal stimuli differenti.
English: EU/1/17/1260/004 50 capsules
Maltese: UE/1/17/1260/004 50 kapsula
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON 1 MG CAPSULES
Maltese: KARTUNA 1 MG KAPSULI
English: Patients with adrenal insufficiency are at risk of life-threatening adrenal crisis during infection so clinical suspicion of infection should be high and specialist advice should be sought early.
Maltese: Pazjenti b'insuffiċjenza adrenali huma f'riskju ta' kriżi adrenali li tpoġġihom f'riskju ta' mewt waqt infezzjoni, għalhekk suspett kliniku ta' infezzjoni għandu jkun għoli u parir mingħand speċjalist għandu jiġi mfittex kmieni.
English: - The top of the capsule is twisted off. - The granules are either poured directly onto the child's tongue, or the granules are poured onto a spoon and placed in the child's mouth.
Maltese: - Il-parti t'isfel tal-kapsula tintgħafas bil-mod. - Il-parti ta' fuq tal-kapsula tintlewa u tinqata'.
English: EU/1/17/1260/001 50 capsules
Maltese: UE/1/17/1260/001 50 kapsula
English: - If your child has any reaction like swelling or shortness of breath after being given Alkindi, get medical help straight away and tell your endocrinologist as soon as possible as these can be signs of an allergic reaction (see section 2).
Maltese: - Jekk it-tifel/tifla tiegħek ikollu/ikollha kwalunkwe reazzjoni bħal nefħa jew qtugħ ta' nifs wara li jingħata/tingħata Alkindi, fittex għajnuna medika immedjatament u għid lillendokrinologu tiegħek malajr kemm jista' jkun għax dawn jistgħu jkunu sinjali ta' reazzjoni allerġika (ara sezzjoni 2).
English: Euphoria
Maltese: FARMAĊEWTIKU
English: EU/1/17/1260/003 50 capsules
Maltese: UE/1/17/1260/003 50 kapsula
English: Alkindi 1 mg granules in capsules for opening
Maltese: Alkindi 1 mg granijiet f'kapsuli għall-ftuħ
English: What Alkindi looks like and contents of the pack
Maltese: Kif jidher Alkindi u l-kontenut tal-pakkett
English: If the granules are sprinkled onto a spoonful of soft food this should be given immediately (within 5 minutes) and not stored for future use.
Maltese: Jekk il-granijiet jinxterdu fuq mgħarfa ta' ikel artab din għandha tingħata immedjatament (f'temp ta' 5 minuti) u mhux tinżamm għal użu fil-futur.
English: EU/1/17/1260/002 50 capsules
Maltese: UE/1/17/1260/002 50 kapsula
English: Alkindi 2 mg granules in capsules for opening
Maltese: Alkindi 2 mg granijiet f'kapsuli għall-ftuħ
English: Alkindi 5 mg granules in capsules for opening
Maltese: Alkindi 5 mg granijiet f'kapsuli għall-ftuħ
English: The following adverse reactions have been reported in the scientific literature in adult patients for other hydrocortisone medicinal products when given as adrenal insufficiency replacement therapy with frequency not known (cannot be estimated from the available data).
Maltese: Ir-reazzjonijiet avversi li ġejjin ġew irrapportati fil-letteratura xjentifika bi frekwenza mhux magħrufa (ma tistax tittieħed stima mid-data disponibbli) f'pazjenti adulti għal prodotti mediċinali oħra li fihom hydrocortisone meta ngħataw bħala terapija ta' sostituzzjoni għal insuffiċjenza adrenali.
English: The Alkindi dose range administered was 1 mg - 4 mg. Parents/carers (and where possible children) assessed the palatability of Alkindi after administration using a 5-item Likert scale.
Maltese: F'termini ta' palatabilità (togħma), Alkindi ġie vvalutat fil-pożittiv.
English: Alkindi 0.5 mg granules in capsules for opening
Maltese: Alkindi 0.5 mg granijiet f'kapsuli għall-ftuħ
English: Printing ink
Maltese: Linka ta' stampar
English: The capsule is printed with "INF-2.0" in green ink.
Maltese: Il-kapsula hija stampata bil-kitba "INF-2.0" b'linka ħadra.
English: Do not administer via nasogastric tube as there is a risk of nasogastric tube blockage.
Maltese: Tagħtix permezz ta' tubu nażogastriku għax hemm riskju li timblokka t-tubu nażogastriku.
English: Hydrocortisone for replacement therapy can be used during pregnancy The ability of corticosteroids to cross the placenta varies between the different types of corticosteroids, however, hydrocortisone readily crosses the placenta.
Maltese: Tqala, treddigħ u fertilità Hydrocortisone jista' jintuża waqt tqala u treddigħ meta l-ġisem ma jkunx qed jagħmel biżżejjed cortisol. .
English: unwell or has an infection.
Maltese: ikun/tkun marid/a jew ikollu/ikollha infezzjoni.
English: Hydrocortisone belongs to a group of medicines known as corticosteroids.
Maltese: Hydrocortisone jappartjeni għal grupp ta' mediċini magħrufin bħala kortikosterojdi.
English: Date of last renewal: 30/06/2015
Maltese: Data tal-aħħar tiġdid: 30/06/2015
English: Aluminium hydroxide gel .......................................................................... 6.4 mg (aluminium) DEAE-Dextran
Maltese: Aluminium hydroxide gel ............................................................................. 6.4 mg (aluminju) DEAE-Dextran
English: Laboratorios Hipra, S.A. Carretera C-63, km 48.300, Polígono Industrial El Rieral 17170 Amer (Girona) Spain
Maltese: Laboratorios Hipra, S.A. Carretera C-63, km 48.300, Polígono Industrial El Rieral 17170 Amer (Girona) Spanja
English: 1 x 10 doses (20 ml) 10 x 10 doses (20 ml) 1 x 25 doses (50 ml) 1 x 50 doses (100 ml) 1 x 125 doses (250 ml) 1 x 10 doses (20ml) 10 x 10 doses (20 ml) 1 x 25 doses (50 ml) 1 x 50 doses (100 ml)
Maltese: 1 x 10 dożi (20 ml) 10 x 10 dożi (20 ml) 1 x 25 doża (50 ml) 1 x 50 doża (100 ml) 1 x 125 doża (250 ml) 1 x 10 dożi (20ml) 10 x 10 dożi (20 ml) 1 x 25 doża (50 ml) 1 x 50 doża (100 ml)
English: ATCvet code: QI09AB04
Maltese: Kodici ATĊ veterinarja QI09AB04..
English: 50 doses (100 ml) 50 doses (100 ml) 125 doses (250 ml)
Maltese: 50 doża (100 ml) 50 doża (100 ml) 125 doża (250 ml)
English: HIPRA SLOVENSKO, s.r.o.
Maltese: Slovenská republika HIPRA SLOVENSKO, s.r.o.
English: 1 dose (2 ml):
Maltese: OĦRA 1 doża (2 ml):
English: Inactivated Bordetella bronchiseptica, strain 833CER: ........................................9.8 BbCC(*) Recombinant Type D Pasteurella multocida toxin (PMTr): ............................ ≥ 1 MED63(**) (*) Bordetella bronchiseptica Cell Count in log10.
Maltese: Razza ta' Bordetella bronchiseptica inattivata 833CER: ....................................... 9.8 BbCC(*) Tossin ta' Pasteurella multocida Rikombinanti Tip D (PMTr): ........................ ≥ 1 MED63(**) (*) Bordetella bronchiseptica Għadd ta' Ċelloli f'log10.
English: Inactivated Bordetella bronchiseptica, strain 833CER: ............................................ 9.8 BbCC Recombinant Type D Pasteurella multocida toxin (PMTr): ................................... ≥ 1 MED63
Maltese: Razza ta' Bordetella bronchiseptica inattivata 833CER: ........................................... 9.8 BbCC Tossin ta' Pasteurella multocida Rikombinanti Tip D (PMTr): ............................... ≥ 1 MED63
English: EU/2/10/109/004 EU/2/10/109/008 EU/2/10/109/009
Maltese: EU/2/10/109/008
English: HIPRA BENELUX NV Tel: (+32) 09 2964464
Maltese: Luxembourg/Luxemburg HIPRA BENELUX NV Tel: (+32) 09 2964464
English: Aluminium hydroxide DEAE-dextran
Maltese: FARMAĊEWTIKU 6.1 Lista ta' ingredjenti Aluminium hydroxide DEAE-dextran
English: White homogeneous suspension.
Maltese: Sospensjoni omoġenja bajda.
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated ) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Maltese: Il-frekwenza ta' effetti mhux mixtieqa hija definita skont din il-konvenzjoni: - komuni ħafna (aktar minn wieħed f'10 annimali li juru effetti mhux mixtieqa matul il-perjodu ta' kura waħda) - komuni (aktar minn wieħed iżda inqas minn 10 annimali f'100 annimal) - mhux komuni (aktar minn wieħed iżda inqas minn10 annimali f'1,000 annimal) - rari (aktar minn wieħed iżda inqas minn10 annimali f'10,000 annimal) - rari ħafna (inqas minn annimal wieħed f'10,000 annimal, inklużi rapporti iżolati).
English: A. <MANUFACTURER<S> OF THE BIOLOGICAL ACTIVE SUBSTANCE<S> AND>
Maltese: TAS-SUSTANZA(I) BIJOLOĠIKA(ĊI) ATTIVA(I)
English: 20 ml, 50 ml, 100 ml and 250 ml Polyethylene (PET) bottles closed with a rubber stopper and aluminium cap.
Maltese: Fliexken tal-Polyethylene (PET) ta' 20 ml, 50 ml, 100 ml u 250 ml magħluqin b'tapp tal-lastku u b'kappa tal-aluminju.
English: To stimulate active immunity in order to provide passive immunity to the progeny against atrophic rhinitis associated with Bordetella bronchiseptica and Pasteurella multocida infections.
Maltese: Biex tistimula l-immunità attiva sabiex tkun ipprovduta immunità passiva għall-proġenu kontra rinite atrofika assoċjata ma' infezzjonijiet b'Bordetella bronchiseptica u Pasteurella multocida.
English: België/Belgique/Belgien
Maltese: België/Belgique/Belgien HIPRA BENELUX NV Tel.
English: Pharmacotherapeutic group: Inactivated bacterial vaccines (Bordetella and Pasteurella) for pigs.
Maltese: Vaċċini batterjali inattivati (Bordetella u Pasteurella) għall-majjali.
English: Date of first authorisation: 16/09/2010
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI / TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizazzjoni: 16/09/2010
English: - Anaphylactic type reactions have been reported in spontaneous reports and appropriate symptomatic treatment is recommended.
Maltese: - Reazzjonijiet tat-tip anaflattiku ġew rappurtati f'rapporti spontanji u kura sintomatika xierqa hija rakkomandata.
English: An increase of rectal temperature up to 1.5ºC may occur.
Maltese: Tista' sseħħ żieda fit-temperatura tar-rektum ta' massimu ta' 1,5ºC.
English: RHINISENG suspension for injection for pigs.
Maltese: VETERINARJU RHINISENG sospensjoni għal injezzjoni għall-majjali.
English: Discoloration of muscular fibres of the inoculation site (0.5 cm wide x 2 cm long) may be observed at necropsy in 10% of animals.
Maltese: Telfien fil-kulur tal-fibri muskolari tas-sit tattilqima (0.5 cm wisa' x 2 cm tul) jista' jiġi osservat f'nekropsija f'10% tal-annimali.
English: Allow the vaccine to reach room temperature (15-25˚C) before administration.
Maltese: Ħalli l-vaċċin jilħaq temperatura ambjentali (15-25˚C) qabel jingħata.
English: - Cardboard box with 1 PET bottle of 125 doses.
Maltese: - Kaxxa tal-kartun bi flixkun PET 1 ta' 125 doża.
English: Marketing authorisation holder and manufacturer responsible for batch release: LABORATORIOS HIPRA, S.A.
Maltese: Isem u indirizz tal-manufattur tas-sustanzi bioloġiċi attivi Laboratorios Hipra, S.A.
English: Pregnancy: Can be used during pregnancy.
Maltese: Żmien ta' tiżmim: Żero jiem.
English: Revaccination: a single injection should be given 3-4 weeks prior to each subsequent farrowing.
Maltese: Tilqim mill-ġdid: injezzjoni waħda għandha tingħata 3-4 ġimgħat qabel kull tifrigħ sussegwenti.
English: Batch {number}
Maltese: U/JEW UŻU
English: EXP {month/ year} Once opened, use within a 10-hour period, stored at 15 ºC to 25 ºC.
Maltese: Jiskadi {xahar/sena} Ladarba miftuħ, uża fi żmien perjodu ta' 10 sigħat, maħżun f'temperatura ta' 15 ºC sa 25 ºC.
English: (**) Murine Effective Dose 63: vaccination of mice with 0.2 ml of a 5-fold diluted vaccine by subcutaneous route induces seroconversion in at least 63 % of the animals.
Maltese: (**) Doża Effettiva ta' Murine 63: tilqima ta' ġrieden b'0.2 ml ta' vaċċin dilwit 5 darbiet b'rotta taħt ilġilda twassal għal serokonverżjoni f'għallinqas 63% tal-annimali.
English: (**) Murine Effective Dose 63: vaccination of mice with 0.2 ml of a 5-fold diluted vaccine by subcutaneous route induces seroconversion in at least 63% of the animals.
Maltese: (**) Doża Effettiva ta' Murine 63: tilqima ta' ġrieden b'0.2 ml ta' vaċċin dilwit 5 darbiet b'rotta taħt ilġilda twassal għal serokonverżjoni f'għallinqas 63 % tal-annimali.
English: - A transient increase in body temperature of about 0.7°C can occur during the first 6 hours after injection.
Maltese: - Tista' sseħħ żieda temporanja fit-temperatura tal-ġisem ta' madwar 0.7°C matul l-ewwel 6 sigħat wara l-injezzjoni.
English: Challenge studies have demonstrated that passive immunity lasts until piglets are 6 weeks of age while in clinical field trials, the beneficial effects of vaccination (reduction in nasal lesion score and weight loss) are observed until slaughter.
Maltese: Studji ta' sfida urew li l-immunità passiva ddum sakemm il-qżieqeż ikollhom 6 ġimgħat filwaqt li fi provi kliniċi prattiċi, l-effetti ta' benefiċċju tal-vaċċinazzjoni (tnaqqis fl-iskor ta' leżjoni nasali u telf fil-piż) jiġu osservati sal-qatla.
English: Formaldehyde .................................................................................................................. 0.8 mg White homogeneous suspension.
Maltese: Ingredjenti oħra: Formaldehyde .................................................................................................................. 0.8 mg
English: For the passive protection of piglets via colostrum after active immunisation of sows and gilts to reduce the clinical signs and lesions of progressive and non-progressive atrophic rhinitis, as well as to reduce weight loss associated with Bordetella bronchiseptica and Pasteurella multocida infections during the fattening period.
Maltese: Għall-protezzjoni passiva tal-qżieqeż permezz tal-kolostru wara immunizzazzjoni attiva tal-ħnieżer nisa u tal-qżieqeż nisa biex jitnaqqsu s-sinjali kliniċi u l-leżjonijiet ta' rinite atrofika progressiva u mhux progressiva, kif ukoll biex jitnaqqas it-telf tal-piż assoċjat ma' infezzjonijiet ta' Bordetella bronchiseptica u Pasteurella multocida matul il-perjodu ta' tismin.
English: - Cardboard box with 1 PET bottle of 50 doses.
Maltese: - Kaxxa tal-kartun bi flixkun PET 1 ta' 50 doża.
English: For passive protection of piglets via colostrum after active immunisation of sows and gilts to reduce the clinical signs and lesions of progressive and non-progressive atrophic rhinitis, as well as to reduce weight loss associated with Bordetella bronchiseptica and Pasteurella multocida infections during the fattening period.
Maltese: Għall-protezzjoni passiva tal-qżieqeż permezz tal-kolostru wara immunizzazzjoni attiva tal- majjaliet u tal-qżieqeż nisa biex jitnaqqsu s-sinjali kliniċi u l-leżjonijiet ta' rinite atrofika progressiva u mhux progressiva, kif ukoll biex jitnaqqas it-telf tal-piż assoċjat ma' infezzjonijiet ta' Bordetella bronchiseptica u Pasteurella multocida matul il-perjodu ta' tismin.
English: The active substances being a principle of biological origin intended to produce active immunity is not within the scope of Regulation (EC) No 470/2009.
Maltese: Is-sustanza attiva li hija prinċipju ta' oriġini bioloġiku maħsuba sabiex tipproduċi issir djanjosi ta' stat ta' immunità attiva ma taqgħax fi ħdan l-iskop tar-Regolament (KE) Nru 470/2009.
English: EXP {month/year} Once opened, use within a 10-hour period, stored at 15ºC to 25ºC.
Maltese: Jiskadi {xahar / sena} Ladarba jinfetaħ, uża fi żmien 10 sigħat, maħżun f'15ºC sa 25ºC.
English: The first injection should be administered 6-8 weeks before the expected date of farrowing.
Maltese: L-ewwel injezzjoni għandha tingħata 6-8 ġimgħat qabel id-data mistennija tat-tifrigħ.
English: - Cardboard box with 1 or 10 PET bottles of 10 doses.
Maltese: - Kaxxa tal-kartun bi flixkun PET 1 jew 10 ta' 10 dożi.
English: - Cardboard box with 1 PET bottle of 25 doses.
Maltese: - Kaxxa tal-kartun bi flixkun PET 1 ta' 25 doża.
English: No adverse reactions other than already mentioned under point 4.6 can be expected, except for an increase of rectal temperature up to 2ºC.
Maltese: Ma huma mistennija ebda reazzjonijiet avversi għajr dawk diġà msemmija f'punt 6, għajr għal żieda fit-temperatura tar-rektum sa massimu ta' 2ºC.
English: Pigs (sows and gilts).
Maltese: Majjali (majjaliet u qżieqeż nisa).
English: PACKAGE LEAFLET: RHINISENG suspension for injection for pigs
Maltese: RHINISENG sospensjoni għal injezzjoni għall-majjali
English: The company that applied for authorisation is Portola Pharma UK Limited.
Maltese: Il-kumpanija li applikat għall-awtorizzazzjoni hija Portola Pharma UK Limited.
English: It was to be available as capsules.
Maltese: Dan kellu jiġi bħala kapsuli.
English: Refusal of the marketing authorisation for Dexxience (betrixaban) EMA/501901/2018
Maltese: Rifjut tal-awtorizzazzjoni għat-tqegħid fis-suq ta' Dexxience (betrixaban) EMA/501901/2018
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom27 July 2018
Maltese: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom27 ta' Lulju 2018 EMA/501901/2018 EMEA/H/C/004309
English: Refusal of the marketing authorisation for Dexxience (betrixaban)
Maltese: Dexxience (betrixaban)
English: The active substance in Dexxience, betrixaban, is a ‘factor Xa inhibitor'.
Maltese: Is-sustanza attiva f'Dexxience, il-betrixaban, hija “inibitur tal-fattur Xa”.
English: What is Dexxience?
Maltese: X'inhu Dexxience?
English: Dexxience is a medicine that contains the active substance betrixaban.
Maltese: Dexxience huwa mediċina li fiha s-sustanza attiva betrixaban.
English: On 22 March 2018, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Dexxience, intended for the prevention of venous thromboembolism.
Maltese: Fit-22 ta' Marzu 2018, il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) adotta opinjoni negattiva, li fiha rrakkomanda r-rifjut tal-awtorizzazzjoni għat-tqegħid fis-suq għall-prodott mediċinali Dexxience, maħsub għall-prevenzjoni ta' tromboemboliżmu venuż.
English: This means that it blocks factor Xa, a protein which is involved in the production of thrombin.
Maltese: Dan ifisser li din timblokka lfattur Xa, proteina li hija involuta fil-produzzjoni tat-trombina.
English: Dexxience was expected to be used to prevent venous thromboembolism (formation of blood clots in veins).
Maltese: Dexxience kien mistenni li jintuża biex jipprevjeni tromboemboliżmu venuż (formazzjoni ta' emboli taddemm fil-vini).
English: The company presented the results of one main study involving over 7,500 adults who had been admitted to hospital for a recent medical illness.
Maltese: Il-kumpanija ppreżentat ir-riżultati ta' studju ewlieni wieħed li involva aktar minn 7,500 adult li ddaħħlu l-isptar għal marda medika riċenti.
English: What was Dexxience expected to be used for?
Maltese: Għal xiex kien mistenni li jintuża Dexxience?
English: The patients were at high risk of venous thromboembolism because of their age, presence of a protein indicating a blood clot, previous blood clots, cancer and lack of mobility during hospital treatment.
Maltese: Il-pazjenti kienu f'riskju għoli ta' tromboemboliżmu venuż minħabba l-età tagħhom, il-preżenza ta' proteina li tindika embolu tad-demm, emboli tad-demm preċedenti, kanċer u nuqqas ta' mobilità waqt il-kura l-isptar.
English: The main measure of effectiveness was the occurrence of deep vein thrombosis (blood clot in a deep vein, usually in the leg), or of pulmonary embolism (blood clot in the lung), or death from a blood clot.
Maltese: Il-kejl ewlieni tal-effikaċja kien lokkorrenza ta' trombożi f'vina profonda (embolu tad-demm f'vina profonda, normalment fir-riġel), jew ta' emboliżmu pulmonari (embolu tad-demm fil-pulmun), jew mewt minn embolu tad-demm.
English: After considering the grounds for this request, the CHMP re-examined the opinion and confirmed the refusal of the marketing authorisation on 26 July 2018.
Maltese: Wara li kkunsidra r-raġunijiet għal din it-talba, is-CHMP eżamina l-opinjoni mill-ġdid u kkonferma r-rifjut tal-awtorizzazzjoni għattqegħid fis-suq fis-26 ta' Lulju 2018.
English: If you are in a clinical trial and need more information about your treatment, contact the doctor who is treating you in the clinical trial.
Maltese: Jekk inti qed tieħu sehem fi prova klinika u teħtieġ aktar informazzjoni dwar il-kura tiegħek, ikkuntattja lit-tabib li jkun qed jagħtik il-kura fil-prova klinika.