FrancophonIA/ELRC3.0 huggingface dataset:
English: In patients taking Ristaben on its own, HbA1c levels fell from around 8.0% at the start of the studies by 0.48% after 18 weeks and 0.61% after 24 weeks.
Maltese: F'pazjenti li ħadu Ristaben waħdu, il-livelli tal-HbA1c naqsu minn madwar 8.0% fil-bidu tal-istudji b'0.48% wara 18-il ġimgħa u b'0.64% wara 24 ġimgħa.
English: • in combination with metformin or a PPAR-gamma agonist (a type of diabetes medicine) such as a thiazolidinedione, in patients who are not satisfactorily controlled on metformin or the PPARgamma agonist used on its own;
Maltese: • flimkien mal-metformina jew ma' agonista PPAR gamma (tip ieħor ta' mediċina tad-dijabete), bħattijażolidinedjonu, f'pazjenti li ma jkunux ikkontrollati b'mod sodisfaċenti bil-metformina jew blagonista PPAR gamma waħdu;
English: A risk management plan has been developed to ensure that Ristaben is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiżgura li Ristaben jintuża bl-aktar mod sigur possibbli.
English: • in combination with both metformin, and a sulphonylurea or a PPAR-gamma agonist, in patients who are not satisfactorily controlled on the two medicines;
Maltese: • flimkien jew mal-metformina, u mas-sulfonilurea jew agonista PPAR gamma, f'pazjenti li ma jkunux ikkontrollati b'mod sodisfaċenti biż-żewġ mediċini;
English: HbA1c levels by 0.67% after 24 weeks, compared with a fall of 0.02% in the patients adding placebo.
Maltese: Biż-żieda ta' Ristaben mal-metformina, il-livelli talHbA1c tnaqqsu b'0.67% wara 24 ġimgħa, apparagun ma' tnaqqis ta' 0.02% f'pazjenti li żiedu l plaċebo.
English: • four of the studies compared Ristaben with placebo (a dummy treatment).
Maltese: • erba' studji qabblu Ristaben ma' plaċebo (kura finta).
English: The other study compared Ristaben with metformin, used on their own, in 1,058 patients;
Maltese: L-istudju lieħor qabbel Ristaben mal-metformina, użati waħedhom, f'1,058 pazjent;
English: This authorisation was based on the authorisation granted to Januvia in 2007 (‘informed consent').
Maltese: Din l-awtorizzazzjoni kienet ibbażata fuq l-awtorizzazzjoni mogħtija lil Januvia fl-2007 (‘kunsens infurmat').
English: In patients with moderately or severely reduced kidney function the dose of Ristaben should be reduced.
Maltese: F'pazjenti li jkollhom tnaqqis moderat jew gravi fil-funzjoni tal-kliewi d-doża ta' Ristaben għandha titbaxxa.
English: Why has Ristaben been approved?
Maltese: Għaliex ġie approvat Ristaben?
English: How has Ristaben been studied?
Maltese: Kif ġie studjat Ristaben?
English: • in combination with a sulphonylurea (another type of diabetes medicine) in patients who are not satisfactorily controlled with a sulphonylurea used on its own and in whom metformin is not suitable;
Maltese: • flimkien ma' sulfonilurea (sulphonylurea) (tip ta' mediċina oħra tad-dijabete) f'pazjenti li mhumiex kontrollati b'mod sodisfaċenti b'sulfonilurea waħedha u f'pazjenti li għalihom il-metformina mhijiex adegwata;
English: If Ristaben is taken with a sulphonylurea or insulin, the dose of the sulphonylurea or insulin may need to be lowered to reduce the risk of hypoglycaemia (low blood sugar levels).
Maltese: Jekk Ristaben jittieħed mas-sulfonilurea jew malinsulina, jista' jenħtieġ li d-doża tas-sulfonilurea jew tal-insulina titbaxxa ħalli jitnaqqas ir-riskju ta' ipogliċemija (livelli baxxi ta' zokkor fid-demm).
English: Ristaben was studied in nine studies involving almost 6,000 patients with type 2 diabetes whose blood glucose levels were not adequately controlled:
Maltese: Ristaben ġie studjat f'disa' studji fuq kważi 6,000 pazjent bid-dijabete tat-tip 2 li l-livelli tal-glukożju fid-demm tagħhom ma kinux ikkontrollati b'mod adegwat:
English: For the full list of all side effects and restrictions with Ristaben, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet kollha b'Ristaben, ara l-fuljett ta' tagħrif.
English: What is the risk associated with Ristaben?
Maltese: X'inhu r-riskju assoċjat ma' Ristaben?
English: These hormones are released after a meal and stimulate the pancreas to produce insulin.
Maltese: Dawn l-ormoni jiġu rilaxxati wara ikla u jistimulaw lill-frixa biex tipproduċi l-insulina.
English: MA (EU) Numbers (Invented) name
Maltese: Isem (ivvintat)
English: Ablavar gadofosveset trisodium
Maltese: Ablavar gadofosveset trisodju
English: The marketing authorisation holder is TMC Pharma Services Ltd.
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq hija l-kumpanija TMC Pharma Services Ltd.
English: Ablavar was studied in four studies involving 693 patients.
Maltese: L-istħarriġ dwar Ablavar sar f'erba' studji li involvew 693 pazjent.
English: The sensitivity was improved by between 6 and 42%, which means that between 6 and 42% more stenoses were detected when Ablavar was used than when it was not used.
Maltese: Is-sensittività ttejbet b'bejn 6 u 42%, jiġifieri żieda ta' 6 u 42% fis-sejba ta' stenożijiet meta ntuża Ablavar minn meta dan ma ntużax.
English: The active substance in Ablavar, gadofosveset trisodium, contains gadolinium, a ‘rare-earth' metal element.
Maltese: Is-sustanza attiva f'Ablavar, jiġifieri l-gadofosveset trisodju, fiha l-gadolinju, li huwa element metalliku minn dawk magħrufa bħala ‘artijiet rari' (‘rare earth').
English: The most common side effects with Ablavar (seen in more than 1 patient in 100) are headache, paraesthesia (unusual sensations like pins and needles), dysgeusia (taste disturbances), a burning sensation, vasodilatation (widening of the blood vessels, including reddening of the skin), nausea (feeling sick), pruritus (itching) and feeling cold. For the full list of all side effects reported with Ablavar, see the package leaflet.
Maltese: L-aktar effetti sekondarji komuni rraportati bl-użu ta' Ablavar (li dehru f'aktar minn pazjent 1 minn 100) kienu wġigħ ta' ras, parestesija (tnemnim mhux tas-soltu), disgewsija (disturbi fit-togħma), sensazzjoni ta' ħruq, twessigħ fl-arterji u fil-vini inkluż ħmura fil-ġilda, nawżja (dardir), ħakk u sensazzjoni ta' ksieħ.
English: This document is a summary of the European public assessment report (EPAR) for Ablavar.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Ablavar.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Vasovist on 3 October 2005.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Vasovist fit-3 ta' Ottubru 2005.
English: Ablavar is given as an injection into a vein lasting about 30 seconds.
Maltese: Ablavar jingħata b'titqiba fil-vina li ddum madwar 30 sekonda.
English: Once injected, gadolinium interacts with the water molecules.
Maltese: Meta jingħata b'titqiba, il-gadolinju jinteraġixxi mal-molekuli tal-ilma.
English: What is Ablavar?
Maltese: X'inhu Ablavar?
English: Previously known as Vasovist.
Maltese: 1 Qabel magħruf bħala Vasovist.
English: Ablavar is a solution for injection that contains the active substance gadofosveset trisodium.
Maltese: Ablavar huwa soluzzjoni għal injezzjoni li fih is-sustanza attiva gadofosveset trisodju.
English: Why has Ablavar been approved?
Maltese: Għaliex ġie approvat Ablavar?
English: The name of the medicine was changed to Ablavar on 10 January 2011.
Maltese: L-isem tal-mediċina nbidel u sar Ablavar fl-10 ta' Jannar 2011.
English: The marketing authorisation is valid for an unlimited period.
Maltese: Din lawtorizzazzjoni hija valida għal perjodu bla limitu.
English: In Ablavar, the gadolinium is attached to another chemical so that the metal is not released in the body, and prepared so that it attaches to proteins in the blood.
Maltese: F'Ablavar, il-gadolinju jeħel ma' sustanza kimika oħra sabiex il-metall ma jerħix fil-ġisem, u jkun imħejji apposta biex jeħel mal-proteini fid-demm.
English: It is used in patients who are undergoing magnetic resonance angiography (MRA), a procedure where pictures of the flow of the blood in the body are taken using a scan called magnetic resonance imaging (MRI).
Maltese: Dan jintuża f'pazjenti li tkun qed issirilhom anġjografija b'riżonanza manjetika (MRA), li hija proċedura li tiġbed ritratti tal-fluss tad-demm fil-ġisem bi skanner imsejjaħ riżonanza manjetika għall-immaġni (magnetic resonance imaging - MRI).
English: How has Ablavar been studied?
Maltese: Kif ġie studjat Ablavar?
English: What is the risk associated with Ablavar?
Maltese: X'inhuma r-riskji assoċjati ma' Ablavar?
English: The CHMP decided that Ablavar's benefits are greater than its risks and recommended that it be given marketing authorisation.
Maltese: Is-CHMP iddeċieda li l-benefiċċji ta' Ablavar huma akbar mir-riskji tiegħu u għaldaqstant irrakkomanda li jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: Ablavar should only be used by doctors who have experience in diagnostic imaging.
Maltese: Ablavar tejjeb ukoll il-preċiżjoni u l-ispeċifiċità tad-dijanjożi.
English: Active substance (1 ml):
Maltese: Sustanza Attiva (1 ml):
English: ul.Franciszka Klimczaka 1, 02-797 Warszawa
Maltese: Boehringer Ingelheim Sp.z o.o. ul.Franciszka Klimczaka 1, 02-797 Warszawa
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 29/03/2019
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 29/03/2019
English: MARKETING AUTHORISATION NUMBER(S) EU/2/18/228/001
Maltese: EU/2/18/228/001
English: IL-ĠERMANJA
Maltese: IL-BELĠJU
English: Cyclo-olefin co-polymer (COC) vial with a thermoplastic elastomer (TPE) stopper and a high-density polyethylene (HDPE) cap.
Maltese: Kunjett ta' kopolimeru ċikloolefin (COC, Cyclo-olefin co-polymer) b'tapp ta' elastomeru termoplastiku (TPE, thermoplastic elastomer) u kappa tal-polietilen ta' densità għolja (HDPE).
English: Boehringer Ingelheim RCV GmbH & Co KG Magyarországi Fióktelepe Lechner Ödön fasor 6.
Maltese: KG Magyarországi Fióktelepe Lechner Ödön fasor 6.
English: Intraarticular use.
Maltese: Uża immedjatament.
English: Excipients (1ml): Equine allogeneic plasma (EAP) 1 ml
Maltese: Plażma alloġenika ekwina (EAP) 1 ml
English: Boehringer Ingelheim RCV GmbH & Co KG Animal Health
Maltese: Boehringer Ingelheim RCV GmbH & Co
English: The active substance being a principle of biological origin intended to produce passive immunity is not within the scope of Regulation (EC) No 470/2009.
Maltese: Is-sustanza attiva li hija prinċipju ta' oriġini bijoloġiku maħsuba sabiex tipproduċi immunità passiva ma taqax fi ħdan l-iskop tar-Regolament (KE) Nru 470/2009.
English: In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
Maltese: Fin-nuqqas ta' studji ta' kompatibilità, dan il-prodott mediċinali veterinarju ma jistax jintuża flimkien ma' prodotti mediċinali veterinarji oħra.
English: Excipients (1 ml):
Maltese: Ingredjenti oħra (1 ml):
English: Using appropriate gloves, remove the two vials (one vial of cells (1 ml) and one vial of EAP (1ml)) from the freezer/liquid nitrogen and thaw immediately at 25 °C - 37 °C, e.g. in a water bath, until the contents in each are completely thawed (approximately 5 minutes).
Maltese: Billi tuża ingwanti xierqa, neħħi ż-żewġ kunjetti (kunjett wieħed ta' ċelluli (1 ml) u kunjett wieħed ta' EAP (1 ml)) mill-friża/min-nitroġenu likwidu u ħoll immedjatament f'temperatura bejn 25 °C - 37 °C, eż. f'banju bl-ilma, sakemm il-kontenut f'kull wieħed jinħall kompletament (madwar 5 minuti).
English: Equine allogeneic plasma suspension:
Maltese: Sospensjoni tal-plażma alloġenika ekwina:
English: Zero days.
Maltese: -90 sa
English: Chondrogenic induced equine allogeneic peripheral blood-derived mesenchymal stem cells (1 ml)
Maltese: Ċelluli staminali mesenkimali derivati minn demm periferali alloġeniċi ekwini indotti minn kondroġeneżi (1 ml)
English: Diluent (EAP) vial: Equine allogeneic plasma
Maltese: Kunjett bid-dilwent (EAP): Plażma alloġenika ekwina
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Arti-Cell Forte suspension for injection for horses Chondrogenic induced equine allogeneic peripheral blood-derived mesenchymal stem cells
Maltese: VETERINARJU Arti-Cell Forte sospensjoni għall-injezzjoni għaż-żwiemel Ċelluli staminali mesenkimali derivati minn demm periferali alloġeniċi ekwini indotti minn kondroġeneżi
English: PACKAGE SIZE One vial (1 ml) of stem cells and one vial (1 ml) of equine allogeneic plasma.
Maltese: Kunjett wieħed (1 ml) ta' ċelluli staminali u kunjett wieħed (1 ml) ta' plażma alloġenika ekwina.
English: Equine allogeneic plasma suspension (diluent): clear yellow suspension.
Maltese: Sospensjoni tal-plażma alloġenika ekwina (id-dilwent): sospensjoni ċara safra.
English: Pharmacotherapeutic group: {not yet assigned} ATCvet code: {not yet assigned}
Maltese: Grupp farmako-terapewtiku:
English: The product must be manipulated and injected using sterile techniques and in a clean environment.
Maltese: Il-prodott għandu jiġi mmanipulat u injettat permezz ta' tekniki sterili u f'ambjent nadif.
English: Name and address of the manufacturer of the biological active substance Global Stem cell Technology (GST) NV Noorwegenstraat 4
Maltese: Isem u indirizz tal-manifattur tas-sustanza bijoloġika attiva Global Stem cell Technology (GST) NV Noorwegenstraat 4
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Diluent for Arti-Cell Forte
Maltese: Dilwent għal Arti-Cell Forte
English: The excipients 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 are considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Maltese: L-addittivi elenkati f'sezzjoni 6.1 tal-Karatteristiċi tal-Prodott fil Qosor huma jew 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 jew 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: Boehringer Ingelheim Animal Health UK Ltd. Bracknell,
Maltese: Boehringer Ingelheim Animal Health UK Ltd.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each 2 ml dose - contains:
Maltese: Kull doża (2 ml) fiha:
English: Active substance (stem cells) vial:
Maltese: Kunjett bis-sustanza attiva (ċelluli staminali):
English: In an experimental model of osteoarthritis in horses these effects were reflected through parameters related to cartilage turnover.
Maltese: F'mudell sperimentali tal-osteoartrite fiż-żwiemel dawn l-effetti ġew riflessi permezz ta' parametri relatati mal-ġenerazzjoni tal-qarquċa.
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)
Maltese: Il-frekwenza ta' effetti mhux mixtieqa hija definita skont din il-konvenzjoni: - komuni ħafna (aktar minn wieħed f'10 annimali li juru effett(i) mhux mixtieqa matul il-perjodu ta' kura waħda) - komuni (aktar minn wieħed iżda inqas minn 10 annimali f'100 annimal)
English: The chondrogenic induction of the mesenchymal stem cells aims to activate chondroprotective mechanisms, such as the production of extracellular matrix.
Maltese: L-induzzjoni kondroġenika taċ-ċelluli staminali mesenkimali timmira li tattiva l-mekkaniżmi kondroprotettivi, bħall-produzzjoni tal-matriċi ekstraċellulari.
English: Chondrogenic induced equine allogeneic peripheral blood-derived mesenchymal stem cell suspension: clear colourless suspension.
Maltese: Sospensjoni ta' ċelluli staminali mesenkimali derivati minn demm periferali alloġeniċi ekwini indotti minn kondroġeneżi: sospensjoni ċara bla kulur.
English: ΓΕΡΜΑΝΙΑ
Maltese: TIKKETTAR
English: 1.4-2.5×106 Chondrogenic induced equine allogeneic peripheral blood-derived mesenchymal stem cells (1 ml)
Maltese: Ċelluli staminali mesenkimali derivati minn demm periferali alloġeniċi ekwini indotti minn kondroġeneżi (1 ml) 1.4-2.5×10
English: According to the benefit-risk assessment of the responsible veterinarian of the individual case a single dose systemic NSAID may be administered on the day of intraarticular injection.
Maltese: Skont valutazzjoni tal-benefiċċju u r-riskju tal-veterinarju responsabbli tal-każ individwali tista' tingħata NSAID sistemika ta' doża waħda fil-jum tal-injezzjoni għal ġol-ġogi.
English: PACKAGE LEAFLET: Arti-Cell Forte suspension for injection for horses
Maltese: Arti-Cell Forte Sospensjoni għall-injezzjoni
English: Chondrogenic induced mesenchymal stem cell suspension:
Maltese: Sospensjoni ta' ċelluli staminali mesenkimali indotti minn kondroġeneżi:
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Arti-Cell Forte suspension for injection for horses
Maltese: VETERINARJU Arti-Cell Forte sospensjoni għall-injezzjoni għaż-żwiemel
English: In the pivotal clinical field study a single systemic administration of an NSAID was given concurrently to treatment with Arti-Cell Forte.
Maltese: Fl-istudju fuq il-post kliniku pivotali ngħata għoti sistemiku wieħed ta' NSAID b'mod konkurrenti ma' kura b'Arti-Cell Forte.
English: This product contains chondrogenic induced equine mesenchymal stem cells and equine allogeneic plasma (EAP).
Maltese: Dan il-prodott fih ċelluli staminali mesenkimali ekwini indotti minn kondroġeneżi u plażma alloġenika ekwina (EAP).
English: Mild increases in lameness and injection site reactions, such as mild to moderate increases in joint swelling and mild increases in temperature at the injection sites, occurred very commonly in the first week after use of the product.
Maltese: Tnaqqis ta' zappip rikkorrenti ħafif sa moderat assoċjat ma' infjammazzjoni tal-ġogi mhux settika fiżżwiemel.
English: Preparation of the suspension for injection:
Maltese: Preparazzjoni tas-sospensjoni għall-injezzjoni:
English: Use only accordingly to the benefit-risk assessment by the responsible veterinarian.
Maltese: Uża biss skont il-valutazzjoni tal-benefiċċju u r-riskju mill-veterinarju responsabbli.
English: Name and address of the manufacturer(s) responsible for batch release Global Stem cell Technology (GST) NV Noorwegenstraat 4
Maltese: Isem u indirizz tal-manifattur(i) responsabbli mill-ħruġ tal-lott Global Stem cell Technology (GST) NV Noorwegenstraat 4
English: Do not administer simultaneously with any other intraarticular veterinary medicinal product.
Maltese: Tagħtix b'mod simultanju ma' xi prodott mediċinali veterinarju intra-artikulari.
English: In case of accidental self-injection this product can cause pain, local inflammatory reactions and swelling at the site of injection which may persist for several weeks and possibly cause fever, seek medical advice immediately and show the package leaflet or the label to the physician.
Maltese: F'każ li tinjetta lilek innifsek b'mod aċċidentali dan il-prodott jista' jikkawża wġigħ, reazzjonijiet infjammatorji lokali u nefħa fis-sit tal-injezzjoni li tista' tippersisti għal diversi ġimgħat u possibbilment jikkawża deni, fittex parir mediku mal-ewwel u qis li turi l-fuljett ta' tagħrif jew ittikketta lit-tabib.
English: Each pack (polycarbonate container) contains a single dose of the product: one vial of stem cell suspension and one vial of EAP suspension.
Maltese: Kull pakkett (kontenitur ta' polikarbonat) fih doża waħda tal-prodott: kunjett wieħed ta' sospensjoni taċ-ċelluli staminali u kunjett wieħed ta' sospensjoni ta' EAP.
English: 1.4-2.5×106 chondrogenic induced equine allogeneic peripheral blood-derived mesenchymal stem cells
Maltese: Jekk tinnota xi effetti serji anke dawk mhux imsemmija f'dan il-fuljett, jew taħseb li l-mediċina ma ħadmitx, jekk jogħġbok informa lit-tabib veterinarju tiegħek.
English: Colourless and clear suspension.
Maltese: Sospensjoni bla kulur u ċara.
English: Store and transport frozen (-90 °C to -70 °C) or in liquid nitrogen.
Maltese: -70 °C) jew f'nitroġenu likwidu.
English: Content (concentratio n)
Maltese: <Kontenut (konċentrazzjoni)>
English: Aortitis [rare frequency]
Maltese: Aortite [frekwenza rari]
English: Filgrastim; lenograstim; lipegfilgrastim; pegfilgrastimAortitis (EPITT no 18940)
Maltese: Filgrastim; lenograstim; lipegfilgrastim; pegfilgrastimAortitis (EPITT nru 18940)
English: Hydroxycarbamide - Cutaneous lupus erythematosus (EPITT no 18939)
Maltese: Hydroxycarbamide - Cutaneous lupus erythematosus (EPITT nru 18939)
English: • [Ritonavir containing products:]
Maltese: • [Prodotti li fihom ritonavir:]
English: • [Lopinavir/ritonavir containing products:]
Maltese: • [Prodotti li fihom lopinavir/ritonavir:]
English: Ritonavir; lopinavir, ritonavir; ombitasvir, paritaprevir, ritonavir; levothyroxine - Interaction possibly leading to decreased levothyroxine efficacy and hypothyroidism (EPITT no 18896)
Maltese: 3. Ritonavir; lopinavir, ritonavir; ombitasvir, paritaprevir, ritonavir; levothyroxine - Interazzjoni li tista' twassal għal tnaqqis fl-effikaċja ta' levothyroxine u ipotirojdiżmu (EPITT nru 18896)
English: Systemic and cutaneous lupus erythematous (frequency very rare) Package leaflet
Maltese: Lupus erythematous sistemika u tal-ġilda (frekwenza rari ħafna) Fuljett ta' tagħrif
English: Possible side effects [Rare frequency] Inflammation of the aorta (the large blood vessel which transports blood from the heart to the body), see section 2.
Maltese: Effetti sekondarji possibbli [Frekwenza rari] Infjammazzjoni tal-aorta (l-arterja l-kbira tad-demm li tittrasporta d-demm mill-qalb għall-ġisem), ara sezzjoni 2.
English: [Ritonavir containing products, including fixed drug combinations, and levothyroxine-containing products whose SPC section 4.5 does not mention a possible interaction with protease inhibitors:]
Maltese: Sommarju tal-karatteristiċi tal-prodott [Il-prodotti li fihom ritonavir, inkluż il-kombinazzjonijiet ta' mediċini fissi u l-prodotti li fihom levothyroxine li s-sezzjoni 4.5 tal-SPC tagħhom ma ssemmix interazzjoni possibbli mal-inibituri talprotease:]
English: Adopted at the 5-8 February 2018 PRAC
Maltese: Adottati fil-PRAC ta' bejn il-5 u t-8 ta' Frar 2018
English: Tell your doctor if you experience these symptoms.
Maltese: It-test attwali li għandu jitħassar huwa maqtugħ.
English: Post-marketing cases have been reported indicating a potential interaction between ritonavir containing products and levothyroxine.
Maltese: Interazzjoni ma' prodotti mediċinali oħra u forom oħra ta' interazzjoni Ġew irrappurtati każijiet ta' wara t-tqegħid fis-suq li indikaw interazzjoni potenzjali bejn prodotti li fihom ritonavir u levothyroxine.
English: The following may affect the way that levothyroxine works: - Ritonavir - used to control HIV and chronic hepatitis C virus
Maltese: - Ritonavir - jintuża sabiex jikkontrolla l-HIV u l-virus tal-epatite Ċ kronika
English: Thyroid-stimulating hormone (TSH) should be monitored in patients treated with levothyroxine at least the first month after starting and/or ending ritonavir treatment.
Maltese: L-ormon li jistimula t-tirojde (TSH) għandu jkun immonitorjat filpazjenti kkurati b'levothyroxine tal-inqas fl-ewwel xahar wara li tinbeda u/jew tintemm il-kura b'ritonavir.
English: Inflammation of the aorta (the large blood vessel which transports blood from the heart to the body) has been reported rarely in cancer patients and healthy donors.
Maltese: Infjammazzjoni tal-aorta (l-arterja l-kbira tad-demm li tittrasporta d-demm mill-qalb għall-ġisem) ġiet irrappurtata b'mod rari f'pazjenti bil-kanċer u f'donaturi b'saħħithom.
English: • [Levothyroxine-containing products whose package leaflet does not mention a possible interaction with protease inhibitors:]
Maltese: • [Il-prodotti li fihom levothyroxine li l-fuljett ta' tagħrif tagħhom ma jsemmix interazzjoni possibbli ma' inibituri tal-protease:]
English: In most cases aortitis was diagnosed by CT scan and generally resolved after withdrawal of G-CSF.
Maltese: Fil-parti l-kbira tal-każijiet l-aortite kienet iddijanjostikata permezz ta' skan CT u ġeneralment għebet wara l-irtirar ta' G-CSF.