FrancophonIA/ELRC3.0 huggingface dataset:
English: • bupropion (used to treat depression (sadness))
Maltese: • bupropion (jintuża biex jikkura d-dipressjoni (dwejjaq))
English: Absorbed radiation dose µGy/MBq
Maltese: .8 Effetti mhux mixtieqa
English: This is about the same as 5 mL beer, or 2 mL wine.
Maltese: Dan hu kważi ekwivalenti għal 5 mL ta' birra jew 2 mL ta' nbid.
English: Patients must undergo appropriate thyroid blocking treatment prior to injection to minimise thyroid uptake of radioactive iodine, for example by oral administration of approximately 120 mg potassium iodide 1 to 4 hours prior to injection of Striascan.
Maltese: Fil-konċentrazzjonijiet kimiċi użati għall-eżaminazzjonijiet dijanjostiċi, Striascan ma jidhirx li għandu xi attività farmakodinamika.
English: • Do not store above 25°C.
Maltese: • Taħżinx f'temperatura 'l fuq minn 25 °C.
English: The safety and efficacy of Striascan in children and adolescents aged 0 to 18 years has not been established.
Maltese: Is-sigurta u l-effikaċja ta' Striascan fi tfal u adolexxenti min età ta' 0 sa 18-il sena ma ġewx determinati.
English: Pack size: 1 vial containing 2.5 mL or 5 mL of solution.
Maltese: Daqs tal-pakkett: kunjett wieħed li fih 2.5 mL jew 5 mL ta' soluzzjoni.
English: - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Maltese: - Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe sustanza mhux attiva elenkata fis-sezzjoni 6.1. - Tqala (ara sezzjoni 4.6).
English: F-91192 Gif-sur-Yvette Cedex FRANCE
Maltese: F-91192 Gif-sur-Yvette Cedex FRANZA
English: EXP: 7 h post-ref.
Maltese: JIS : 7 sigħat wara l-ħin ta' riferiment.
English: Name and address of the manufacturer(s) responsible for batch release CIS BIO International
Maltese: Isem u indirizz tal-manifattur(i) responsabbli għall-ħruġ tal-lott
English: 5 mL vial 48 hours from the end of synthesis (20 hours from the activity reference time stated on the label)
Maltese: 48 siegħa mit-tmiem tas-sinteżi (20 siegħa miż-żmien ta' attività ta' riferiment kif imfisser fuq ittikketta)
English: Ear and labyrinth disorders Vertigo
Maltese: Fertilità Ma sarux studji dwar il-fertilità.
English: You must inform the nuclear medicine doctor before the administration of Striascan if there is a possibility you might be pregnant, if you have missed your period or if you are breast-feeding.
Maltese: Għandek tinforma lit-tabib tal-mediċina nukleari qabel ma tingħata Striascan jekk hemm il-possibbiltà li tista' tkun tqila, jekk ma kellekx l-aħħar mestrwazzjoni, jew jekk qed tredda'.
English: Non-clinical data for ioflupane reveal no special hazard for humans based on conventional studies of safety pharmacology, single and repeated dose toxicity and genotoxicity.
Maltese: Tagħrif mhux kliniku għal ioflupane bbażat fuq studji konvenzjonali ta' sigurtà farmakoloġika, effett tossiku minn dożi singoli u ripetuti u effett tossiku fuq il-ġeni, ma juri l-ebda periklu speċjali għallbnedmin.
English: Remaining organs Effective Dose
Maltese: Doża effettiva
English: The following information is intended for the specialist only:
Maltese: Detentur tal-awtorizzazzjoni għat-tqegħid fis-Suq u l-manifattur:
English: Abnormal images are either asymmetric or symmetric with unequal intensity and/or loss of crescent.
Maltese: Immaġini li mhumiex normali ma jkunux simetriċi jew ikunu simetriċi imma b'intensità differenti u/jew mingħajr il-forma ta' felli.
English: I) at reference time.
Maltese: I) fil-ħin ta' riferiment.
English: Striascan 74 MBq/mL solution for injection ioflupane (
Maltese: MBq/mL soluzzjoni għall-injezzjoni ioflupane (
English: • Because it contains a small amount of radioactivity it can be detected from outside the body using special cameras.
Maltese: • Peress li fih ammont żgħir ta' radjuattività jista' jiġi osservat minn barra l-ġisem permezz ta' kameras speċjali.
English: Striascan 74 MBq/mL solution for injection
Maltese: wkoll isir abbuż minn din il-mediċina)
English: Thymus
Maltese: Mejt
English: What Striascan looks like and contents of the pack Striascan is a colourless solution for injection, supplied in a single amber 15 mL glass vial sealed with a rubber closure and metal overseal.
Maltese: Sabiex tkun possibbli l-azzjoni immedjata f'emerġenżi, il-prodotti mediċinali u l-apparat meħtieġ bħal tubu endotrakeali u ventilatur għandhom ikunu disponibbli immedjatament.
English: Special populations
Maltese: TA'EĊĊIPJENTI
English: The rest is assumed to be distributed uniformly in the remaining organs and tissues.
Maltese: Il-kumplament huwa preżunt li jitqassam b'mod uniformi fl-organi u t-tessuti li jifdal.
English: 15 mL amber glass vial sealed with a rubber closure and metal overseal.
Maltese: Kunjett ta' 15 mL tal-ħġieġ ta' lewn oranġjo ssiġillat b'tapp tal-gomma u siġill fuq kollox tal-metall.
English: Administration procedures should be carried out in a way to minimise risk of contamination of the medicinal product and irradiation of the operators.
Maltese: Il-proċeduri ta' kif jingħata għandhom isiru b'mod li jnaqqsu r-riskju ta' kontaminazzjoni tal-prodott mediċinali u irradjazzjoni ta' min juża l-prodott.
English: - If you have any further questions, ask your nuclear medicine doctor who will supervise the procedure.
Maltese: - Jekk ikollok aktar mistoqsijiet, staqsi lit-tabib tiegħek tal-mediċina nukleari li se jissorvelja lproċedura.
English: To minimise the potential for pain at the injection site during administration, a slow intravenous injection (not less than 15 to 20 seconds) via an arm vein is recommended.
Maltese: Biex jiġi minimizzat il-potenzjal ta' wġigħ fis-sit talinjezzjoni waqt li jkun qed jiġi injettat l-prodott, hu rakkomandat li l-injezzjoni fil-vina tingħata bilmod (mhux inqas minn 15 sa 20 sekonda) minn ġo vina tad-driegħ.
English: Striascan is unable to discriminate between dementia with Lewy bodies and Parkinson's disease dementia.
Maltese: Striascan ma jistax jagħraf bejn dimenzja u l-korpi Lewy u dimenzja minħabba l-marda ta' Parkinson.
English: Your nuclear medicine doctor will suggest that you drink plenty of fluids to help the body get rid of the medicine.
Maltese: It-tabib tiegħek tal-mediċina nukleari ser jissuġġerilek li tixrob ħafna fluwidi biex iħaffef l-eliminazzjoni tal-mediċina minn ġismek.
English: Potential for hypersensitivity or anaphylactic reactions If hypersensitivity or anaphylactic reactions occur, the administration of the medicinal product must be discontinued immediately and intravenous treatment initiated, if necessary.
Maltese: Ma sarux studji dwar l-effett tossiku fuq is-sistema riproduttiva u biex jiġi vvalutat ir-riskju ta' kanċer ta' ioflupane.
English: 2.5 mL vial 35 hours from the end of synthesis (7 hours from the activity reference time stated on the label)
Maltese: 35 siegħa mit-tmiem tas-sinteżi (7 sigħat miż-żmien ta' attività ta' riferiment kif imfisser fuq ittikketta)
English: Pregnancy and breast-feeding
Maltese: Żieda fl-aptit
English: Alternative techniques which do not involve radioactivity should be considered.
Maltese: Tekniki alternattivi li ma jinvolvux radjuattività għandhom jiġu kkunsidrati.
English: INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS
Maltese: ISTRUZZJONIJIET GĦALL-PREPARAZZJONI TA' PRODOTTI
English: • cocaine (sometimes used as an anaesthetic for nose surgery; also a drug of abuse)
Maltese: • kokaina (xi kultant tintuża bħala anestetiku għal operazzjoni fl-imnieħer; jista' wkoll isir abbuż minn din il-mediċina)
English: EMA/681281/2015 EMEA/H/C/000336
Maltese: EMA/681281/2015 EMA/H/C/000336
English: The full EPAR for Zometa can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Zoledronic acid
Maltese: Aċidu zoledroniku
English: The European Commission granted a marketing authorisation valid throughout the European Union for Zometa on 20 March 2001.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Zometa valida fl-Unjoni Ewropea kollha fl-20 ta' Marzu 2001.
English: The usual dose of Zometa is one infusion of 4 mg over at least 15 minutes.
Maltese: Id-doża normali ta' Zometa hija ta' infużjoni waħda ta' 4 mg fuq perjodu ta' mill-inqas 15-il minuta.
English: The active substance in Zometa, zoledronic acid, is a bisphosphonate.
Maltese: Is-sustanza attiva f'Zometa, l-aċidu zoledroniku, hija bisfosfonat.
English: Zometa is a medicine that contains the active substance zoledronic acid.
Maltese: Zometa huwa mediċina li fiha s-sustanza attiva aċidu zoledroniku.
English: This is a summary of the European public assessment report (EPAR) for Zometa.
Maltese: Dan id-dokument huwa sommarju tar-rapport pubbliku ewropew ta' valutazzjoni (EPAR) għal Zometa.
English: It is available as a powder (4mg) and solvent, and as a concentrate (4mg/5ml), both of which are made up into a solution for infusion (drip into a vein), and as a pre-prepared solution for infusion (4mg/100ml).
Maltese: Jiġi bħala trab (4mg) u solvent, kif ukoll konċentrat (4mg/5ml), li t-tnejn jitħalltu biex isiru soluzzjoni għal infużjoni (dripp fil-vina) u bħala soluzzjoni ppreparata minn qabel għal infużjoni (4mg/100ml).
English: Zometa has also been compared with pamidronate in two main studies involving a total of 287 adults with hypercalcaemia caused by tumours.
Maltese: Zometa tqabbel ukoll ma' pamidronat f'żewġ studji ewlenin li involvew total ta' 287 adult li jbatu minn iperkalċemija kkawżata minn tumuri.
English: In the third study, Zometa was as effective as pamidronate: 44% of the patients receiving Zometa had at least one skeletal event, compared with 46% of those receiving pamidronate.
Maltese: Fit-tielet studju, Zometa kien effettiv daqs pamidronat: 44% tal-pazjenti li ngħataw Zometa kellhom mill-inqas avveniment skeletali wieħed, meta mqabbla mas-46% ta' dawk li ngħataw pamidronat.
English: Why has Zometa been approved?
Maltese: Għaliex ġie approvat Zometa?
English: Other information about Zometa
Maltese: Informazzjoni oħra dwar Zometa
English: In the first two studies of patients with bone metastases, the number of patients who developed a new skeletal event was lower with Zometa (33 to 38%) than with placebo (44%).
Maltese: Fl-ewwel żewġ studji ta' pazjenti b'metastasi fl-għadam, in-numru ta' pazjenti li żviluppaw avveniment skeletali ġdid kien inqas b'Zometa (33 sa 38%) milli bil-plaċebo (44%).
English: What is the risk associated with Zometa?
Maltese: X'inhu r-riskju assoċjat ma' Zometa?
English: The most common side effect with Zometa (seen in more than 1 patient in 10) is hypophosphataemia (low blood phosphate levels).
Maltese: L-effett sekondarju l-aktar komuni b'Zometa (li deher f'iktar minn pazjent 1 minn kull 10) huwa ipofosfatemija (livelli baxxi ta' fosfat fid-demm).
English: Looking at the results of the two studies together, 88% of the patients receiving Zometa had normal calcium levels within 10 days after treatment, compared with 70% of those receiving pamidronate.
Maltese: Ħarsa lejn ir-riżultati taż-żewġ studji flimkien turi li 88% tal-pazjenti li ngħataw Zometa kellhom livelli normali ta' kalċju fi żmien 10 ijiem wara l-kura, meta mqabbla ma' 70% ta' dawk li kienu qed jieħdu pamidronat.
English: This includes fractures (breaks in the bone), spinal compression (when the spinal cord is compressed by the bone), bone disorders needing radiotherapy (treatment with radiation) or surgery, and hypercalcaemia (high levels of calcium in the blood).
Maltese: Dan inkluda kwalunkwe kumplikazzjoni tal-għadam li kien hemm bżonn tiġi kkurata b'radjuterapija jew intervent kirurġiku, kwalunkwe frattura jew kwalunkwe kompressjoni fis-sinsla taddahar.
English: Osteonecrosis of the jaw (damage to the bones of the jaw, which could lead to pain, sores in the mouth or loosening of teeth) has been reported uncommonly (seen in between 1 and 10 patients in 1,000).
Maltese: L-osteonekrożi tax-xedaq (ħsara lill-għadam taxxedaq, li tista' twassal għal uġigħ, selħiet fil-ħalq jew laxkament fis-snien) rari kienet irrappurtata (dehret f'bejn pazjent 1 u 10 minn kull 1,000).
English: The main measure of effectiveness was the number of patients whose calcium levels had returned to normal within 10 days after treatment.
Maltese: Il-kejl ewlieni tal-effikaċja kien in-numru ta' pazjenti li l-livelli talkalċju tagħhom irritornaw għan-normal wara 10 ijiem ta' kura.
English: It is not recommended for patients with severe kidney problems.
Maltese: Ma huwiex rakkomandat għal pazjenti bi problemi serji fil-kliewi.
English: Zometa must not be used in people who are hypersensitive (allergic) to zoledronic acid, other bisphosphonates or any of the other ingredients.
Maltese: Zometa ma għandux jintuża f'persuni ipersensittivi (allerġiċi) għall-aċidu zoledroniku, għal bisfosfonati oħra jew għal xi ingredjenti oħra tiegħu.
English: How does Zometa work?
Maltese: Kif jintuża Zometa?
English: The CHMP decided that Zometa's benefits are greater than its risks and recommended that it be given marketing authorisation.
Maltese: Is-CHMP iddeċieda li l-benefiċċji ta' Zometa huma akbar mir-riskji tiegħu u rrakkomanda li jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: What measures are being taken to ensure the safe and effective use of Zometa?
Maltese: X'miżuri qed jitteħdu biex jiġi żgurat l-użu sigur u effettiv ta' Zometa?
English: When used to prevent bone complications, the infusion can be repeated every three to four weeks, and patients should also take supplements of calcium and vitamin D. A lower dose is recommended for patients with bone metastases (when cancer has spread to the bone) if they have mild to moderate problems with their kidneys.
Maltese: Hija rakkomandata doża iżgħar għall-pazjenti li jkollhom metastasi fl-għadam (meta l-kanċer ikun infirex mal-għadam) jekk ikollhom problemi ħfief sa moderati fil-kliewi.
English: A risk management plan has been developed to ensure that Zometa is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Zometa jintuża bl-aktar mod sigur possibbli.
English: phenylbutazone, azapropazon and oxyfenbutazone,
Maltese: phenylbutazone, azapropazon u oxyfenbutazone,
English: insulin and oral antidiabetic products,
Maltese: insulina u prodotti orali anti-dijabetiċi,
English: Packs of 14, 28, 56, 84 or 112 tablets.
Maltese: Pakketti ta' 14, 28, 56, 84 jew 112-il pillola.
English: Glimepiride is metabolized by cytochrome P450 2C9 (CYP2C9).
Maltese: Glimepiride jimmetabolizza bis-cytochrome P450 2C9 (CYP2C9).
English: Opaque blisters (PVC/PVDC/aluminium).
Maltese: Pakketti ta' folji blister opaki (PVC/PVDC aluminju).
English: salicylates and p-amino-salicylic acid,
Maltese: salicylates u aċidu p-amino-saliċiliku,
English: Stop taking Avaglim.
Maltese: Tieħux Avaglim.
English: Protein binding was greater than 99.5%.
Maltese: L-irbit tal-proteini kien aktar minn 99.5%.
English: Manufacturer: Glaxo Wellcome S.A., Avenida de Extremadura 3, 09400 Aranda de Duero, Burgos,
Maltese: Glaxo Wellcome S.A., Avenida de Extremadura 3, E-09400 Aranda de Duero, Burgos, Spanja
English: Rosiglitazone showed moderate inhibition of CYP2C8 (IC50 18 µM) and low inhibition of CYP2C9 (IC50 50 µM) in vitro (see section 4.5).
Maltese: Rosiglitazone wera inibizzjoni moderata ta' CYP2C8 (IC50 18 µM) u inibizzjoni baxxa ta' CYP2C9 (IC50 50 µM) in vitro (ara sezzjoni 4.5).
English: Glimepiride AUC0-t, AUC0-inf and Cmax were increased by 30%, 19% and 55% respectively, on average.
Maltese: L-AUC0-t, AUC0-inf u Cmax ta' glimepiride żdiedu bi 30%, 19% u 55% rispettivament, bħala medja.
English: The other ingredients are: sodium starch glycollate (Type A), hypromellose (E464), microcrystalline cellulose (E460), lactose monohydrate, magnesium stearate, titanium dioxide (E171), macrogol 400,
Maltese: Is-sustanzi l-oħra huma: sodium starch glycollate (Tip A), hypromellose (E464), microcrystalline cellulose (E460), lactose monohydrate, magnesium stearate, titanium dioxide (E171), macrogol 400, iron oxide black u/jew red (E172).
English: Rosiglitazone is a selective agonist at the PPARγ (peroxisome proliferator activated receptor gamma) nuclear receptor and is a member of the thiazolidinedione class of antihyperglycaemic agents.
Maltese: Rosiglitazone huwa agonist selettiv fir-riċettur nukleari PPARγ (peroxisome proliferator activated receptor gamma) u hu membru tal-kategorija ta' thiazolidinedione ta' aġenti anti-ipergliċemiċi.
English: Avenida de Extremadura, 3 09400 Aranda de Duero
Maltese: Glaxo Wellcome, S.A. Avenida de Extremadura, 3 09400 Aranda de Duero Burgos
English: Since there is no significant in vitro inhibition of CYP1A2, 2A6, 2C19, 2D6, 2E1, 3A or 4A with rosiglitazone, there is a low probability of significant metabolism-based interactions with substances metabolised by these P450 enzymes.
Maltese: Billi m'hemmx inibizzjoni in vitro sinifikanti ta' CYP1A2, 2A6, 2C19, 2D6, 2E1, 3A jew 4A ma' rosiglitazone, hemm probabbilta` żgħira ta' interazzjonijiet sinifikanti bażati fuq metaboliżmu ma' sustanzi metabolizzati b'dawn l-enzimi P450.
English: oestrogens and progestagens, saluretics, thiazide diuretics, thyroid stimulating agents, glucocorticoids, phenothiazine derivatives, chlorpromazine, adrenaline and sympathicomimetics, nicotinic acid (high dosages) and nicotinic acid derivatives,
Maltese: oestrogens u progestagens, saluretics, thiazide diuretics, aġenti li jistimulaw it-tirojde, glucocorticoids, derivattivi tal-phenothiazine, chlorpromazine, adrenaline u sympathicomimetics, aċidu nikotiniku(dożi għolja) u derivattivi ta' l-aċidu nikotiniku, lassattivi (użu fit-tul), phenytoin, diazoxide, glucagon, barbiturates u rifampicin, acetozolamide.
English: Avaglim tablets come in different strengths.
Maltese: Il-pilloli ta' Avaglim jiġu f'dożi differenti.
English: The terminal half-life for radioactivity was about 130 h indicating that elimination of metabolites is very slow.
Maltese: Il-half-life terminali ta' radjoattivita` kienet madwar 130 s li indikat li l-eliminazzjoni tal-metaboliti kienet baxxa ħafna.
English: The risk of fracture appeared to be higher in females relative to control [11.5% vs 6.3%, Risk ratio 1.82 (95% CI 1.37 - 2.41)], than in males relative to control [5.3% vs 4.3%, Risk ratio 1.23 (95% CI 0.85 - 1.77)].
Maltese: Ir-riskju ta' ksur deher li kien ogħla fin-nisa relattiv għall-kontroll [11.5% kontra 6.3%, Proporzjon ta' riskju 1.82 (95% CI 1.37 - 2.41)], milli fl-irġiel relattiv għall-kontroll [5.3% kontra 4.3%, Proporzjon ta' riskju 1.23 (95% CI 0.85 - 1.77)].
English: It cannot be excluded that other inducers (e.g. phenytoin, carbamazepine, phenobarbital, St John's wort) may also affect rosiglitazone exposure.
Maltese: Ma jistax jiġi eskluż li inducers oħra (e.g. phenytoin, carbamazepine, phenobarbital, St John's wort) jistgħu wkoll ikollhom effett fuq lesponiment għal rosiglitazone.
English: Very rare abdominal distension
Maltese: Rari ħafna distensjoni addominali
English: Metabolism and nutrition disorders hypoglycaemia8
Maltese: Mard marbut mal-metaboliżmu u n-nutrizzjoni ipogliċemija 8
English: Rosiglitazone treatment significantly reduced the risk of reaching monotherapy failure (FPG>10.0 mmol/L) by 63% relative to glibenclamide (HR 0.37, CI 0.30-0.45) and by 32% relative to metformin (HR 0.68,
Maltese: Trattament b'rosiglitazone naqqas b'mod sinifikanti ir-riskju li jintlaħaq falliment tal-monterapija (FPG>10.0 mmol/L) b'63% meta mqabbla ma' glibenclamide (HR 0.37, CI 0.30-0.45) u b'32% meta mqabbla ma' metformin (HR 0.68, CI 0.55-0.85) waqt l-andament ta' listudju (sa 72 xahar ta' trattament).
English: anabolic steroids and male sex hormones,
Maltese: sterojdi anaboliċi u ormoni tas-sess maskil,
English: • inflammation of the liver (hepatitis), yellowing of the skin (jaundice)
Maltese: • infjammazzjoni tal-fwied (epatite), sfura fil-ġilda (suffejra)
English: HR and CI for key secondary endpoints were: all-cause death (HR 0.86, CI 0.68-1.08), MACE (Major Adverse Cardiac Events - cardiovascular death, acute myocardial infarction, stroke) (HR 0.93, CI 0.74-1.15), cardiovascular death (HR 0.84, CI 0.59-1.18), acute myocardial infarction (HR 1.14, CI 0.80-1.63) and stroke (HR 0.72, CI 0.49-1.06).
Maltese: Adverse Cardiac Events - mewt kardjovaskulari, infart mijokardijaku akut, puplesija) (HR 0.93, CI 0.74-1.15), mewt kardjovaskulari (HR 0.84, CI 0.59-1.18), infart mijokardijaku akut (HR 1.14, CI 0.80-1.63) u puplesija (HR 0.72, CI 0.49-1.06).
English: Gastrointestinal disorders vomiting
Maltese: Mard gastro-intestinali stitikezza
English: The major metabolites are the cyclohexyl hydroxy methyl derivative (M1) and the carboxyl derivative (M2).
Maltese: Il-metaboli ewlenin huma d-derivattiva cyclohexyl hydroxy methyl (M1) u d-derivattiva carboxyl (M2). CYP2C9 deher li kien involut fil-bijotrasformazzjoni ta' glimepiride għal M1.
English: In a prospective cardiovascular outcomes study (mean follow-up 5.5 years) the primary endpoint events of cardiovascular death or hospitalisation were similar between rosiglitazone and active comparators [HR 0.99 (95% CI 0.85 - 1.16)].
Maltese: Fi studju prospettiv dwar riżultati kardjovaskulari (medja tal-vista ta' wara 5.5 snin) l-avvenimenti tal-endpoint primarja ta' mewt kardjovaskulari jew dħul l-isptar kienu simili bejn rosiglitazone u komparaturi attivi [HR 0.99 (95% CI 0.85 - 1.16)].
English: In double-blind clinical trials with rosiglitazone the incidence of elevations of ALT greater than three times the upper limit of normal was equal to placebo (0.2%) and less than that of the active comparators (0.5% metformin/sulphonylureas).
Maltese: Fi studji kliniċi double-blind b'rosiglitazone l-inċidenza ta' għoli ta' ALT aktar minn tliet darbiet tallimitu ta' fuq tan-normal kienet ugwali għall-plaċebo (0.2%) u inqas minn dik tal-komparaturi attivi (0.5% metformin/sulphonylureas).
English: H2 antagonists, betablockers, clonidine and reserpine may lead to either potentiation or weakening of
Maltese: H2, betablockers, clonidine u reserpine jistgħu jwasslu għal potenzjament jew indeboliment ta' l-effett ta' tnaqqis ta' glukosju fid-demm.
English: 3 In a retrospective analysis of data from 42 pooled short-term clinical studies, the overall incidence of events typically associated with cardiac ischaemia was higher for rosiglitazone containing regimens, 2.00% versus combined active and placebo comparators, 1.53% [hazard ratio (HR) 1.30 (95% confidence interval (CI) 1.004 - 1.69)].
Maltese: 3F'analiżi retrospettiva ta' tagħrif minn 42 studji kliniċi fuq tul ta' żmien qasir, miġbura flimkien, linċidenza ġenerali ta' każi assoċjati tipikament ma' iskemija kardijaka kienet ogħla fil-każ ta' terapija li jkun fiha rosiglitazone, 2.00% kontra komparaturi attivi kombinati u plaċebo, 1.53% [(hazard ratio 1.30 (95% confidence interval (CI) 1.004 - 1.69)].
English: The active substances are rosiglitazone and glimepiride.
Maltese: Is-sustanzi attivi huma rosiglitazone u glimepiride.
English: Accumulation of the metabolites in plasma is expected upon repeated dosing, especially that of the major metabolite (a para-hydroxy-sulphate) for which an 8-fold accumulation is anticipated.
Maltese: Akkumulazzjoni ta' metaboliti filplażma hi mistennija wara dożi ripetuti, speċjalment dik tal-metabolita ewlenija (para-hydroxysulphate) li dwaru tkun antiċipata akkumulazzjoni ta' tmien darbiet aktar.
English: There is limited experience with rosiglitazone in patients with elevated liver enzymes (ALT >2.5X upper limit of normal).
Maltese: Teżisti esperjenza limitata ta' rosiglitazone f'pazjenti b'livell għoli ta' enzimi fil-fwied (ALT >2.5X limitu ta' fuq tan-normal).
English: SmithKline Beecham Ltd, 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom.
Maltese: SmithKline Beecham Ltd 980 Great West Road Brentford, Middlesex TW8 9GS Ir-Renju Unit
English: No clinically relevant interactions with digoxin, the CYP2C9 substrate warfarin, the CYP3A4 substrates nifedipine, ethinylestradiol or norethindrone were observed after co-administration with
Maltese: Ma ġew osservati ebda interazzjonijiet kliniċi rilevanti ma' digoxin, is-substrat CYP2C9 warfarin, issubstrati CYP3A4 nifedipine, ethinylestradiol jew norethindrone wara li ttieħdu flimkien ma' rosiglitazone.