FrancophonIA/ELRC3.0 huggingface dataset:
English: After 2 weeks the dose may be increased, based on acceptable safety and tolerability, to 10 mg and then, at a minimum of 4-week intervals, to 20 mg, 40 mg, and to the maximum recommended dose of 60 mg (see section 4.8).
Maltese: Wara ġimagħtejn id-doża tista' tiżdied, abbażi ta' sigurtà u tollerabbiltà aċċettabbli, għal 10 mg u mbagħad, f'intervalli minimi ta' 4 ġimgħat, għal 20 mg, 40 mg, u sad-doża massima rakkomandata ta' 60 mg (ara s-sezzjoni 4.8).
English: EXP
Maltese: Valurpb
English: The capsule is a white cap/white body hard capsule of 19.4 mm, printed with black ink imprinted with “20 mg” on body and “A733” on cap.
Maltese: Il-kapsula hija kapsula iebsa b'għatu abjad /parti prinċipali bajda ta' 19.4 mm, stampata b'linka sewda u stampata b'“20 mg” fuq il-parti prinċipali u b'“A733” fuq l-għatu.
English: When co-administering CYP3A4 inducers (i.e. aminoglutethimide, nafcillin, non-nucleoside reverse transcriptase inhibitors, phenobarbital, rifampicin, carbamazepine, pioglitazone, glucocorticoids, modafinil and phenytoin) with Lojuxta, the possibility of a drug-drug interaction affecting efficacy should be considered.
Maltese: (jiġifieri aminoglutethimide, nafcillin, inibituri tan-non-nucleoside reverse transcriptase, phenobarbital, rifampicin, carbamazepine, pioglitazone, glucocorticoids, modafinil u phenytoin) ma'
English: clotrimazole)
Maltese: Madankollu,
English: The medicinal product is contraindicated in patients with moderate or severe hepatic impairment and those with unexplained persistent abnormal liver function tests.
Maltese: Il-prodott mediċinali huwa kontraindikat f'pazjenti b'indeboliment epatiku moderat jew sever u dawk b'testijiet anormali persistenti u inspjegabbli tal-funzjoni tal-fwied.
English: Nausea
Maltese: UŻU
English: • flatulence (wind)
Maltese: • żieda fl-aptit
English: Abdominal pain Abdominal pain upper Flatulence
Maltese: • demm jew proteina fl-awrina
English: Lojuxta 5 mg hard capsules Lojuxta 10 mg hard capsules Lojuxta 20 mg hard capsules Lojuxta 30 mg hard capsules Lojuxta 40 mg hard capsules Lojuxta 60 mg hard capsules lomitapide
Maltese: Lojuxta 5 mg kapsuli ibsin Lojuxta 10 mg kapsuli ibsin Lojuxta 20 mg kapsuli ibsin Lojuxta 30 mg kapsuli ibsin Lojuxta 40 mg kapsuli ibsin Lojuxta 60 mg kapsuli ibsin lomitapide
English: SPECIAL STORAGE CONDITIONS Store below 30°C.
Maltese: 6.4 Prekawzjonijiet speċjali għall-ħażna Aħżen f'temperatura taħt it-30°C.
English: Excipient with known effect Each hard capsule contains 70.12 mg of lactose (as monohydrate) (see section 4.4).
Maltese: 12 mg ta' lattożju (bħala monoidrat) (ara s-sezzjoni 4.4).
English: • Advice on monitoring liver function (measuring hepatic enzymes and total bilirubin) before and during treatment with Lojuxta and routine screening to detect presence of steatohepatitis and hepatic fibrosis including specific details of the screening tests at baseline and annually as follows: - Imaging for tissue elasticity, e.g. Fibroscan, acoustic radiation force impulse (ARFI), or magnetic resonance (MR) elastography; - Measurement of biomarkers and/or scoring methods.
Maltese: • Parir dwar il-monitoraġġ tal-funzjoni tal-fwied (kejl tal-enzimi epatiċi u l-bilirubin totali) qabel u waqt kura b'Lojuxta u skrining ta' rutina biex tiġi skoperta l-preżenza ta' steatohepatitis u fibrożi epatika nkluż dettalji speċifiċi tat-testijiet tal-iskrining fil-linja bażi u fuq bażi annwali kif ġej:
English: Chest pain Chills
Maltese: TA' KIF JINGĦATA
English: Patients treated with lomitapide should be advised of the potential risk of dehydration in relation to gastrointestinal adverse reactions and take precautions to avoid fluid depletion.
Maltese: Pazjenti trattati b'lomitapide għandhom jingħataw parir dwar ir-riskju potenzjali ta' deidrazzjoni fir-rigward ta' reazzjonijet avversi gastrointestinali u jieħdu prekawzjonijiet biex jevitaw nuqqas ta' fluwidi.
English: If you use contraceptive pills and suffer from an episode of diarrhoea or vomiting that lasts more than 2 days, you must use an alternative method of contraception (e.g. condoms, diaphragm) for 7 days following resolution of symptoms.
Maltese: Jekk tuża pilloli kontraċettivi u tbati minn episodju ta' dijarea jew rimettar li jdumu aktar minn jumejn, għandek tuża metodu alternattiv ta' kontraċezzjoni (eż. kondoms, dijaframma) għal 7 ijiem wara li s-sintomi jkunu rriżolvew.
English: Recommendation concerning co-administration with Lojuxta no clinically meaningful increase in lomitapide exposure was observed.
Maltese: Rakkomandazzjoni dwar l-għoti flimkien ma' Lojuxta klinikament sinifikanti flesponiment għal lomitapide.
English: The recommended starting dose is a 5 mg capsule each day.
Maltese: Id-doża rakkomandata tal-bidu hija kapsula ta' 5 mg kuljum.
English: Muscle spasms
Maltese: Gass fl-istonku
English: o Ginkgo (to improve memory)
Maltese: o Ginkgo (biex itejjeb il-memorja)
English: In the Phase 3 study, 3 of 4 patients with ALT elevations >5x ULN reported alcohol consumption beyond the limits recommended in the protocol.
Maltese: Fl-istudju tal-Fażi 3, 3 minn 4 pazjenti b'żidiet fl-ALT >5x ULN irrapportaw konsum tal-alkoħol lil hinn millimiti rakkomandati fil-protokoll.
English: In this study, the median levels of serum vitamin E, ALA, linoleic acid, EPA, DHA, and arachidonic acid decreased from baseline to Week 26 but remained above the lower limit of the reference range.
Maltese: F'din l-istudju, il-livelli medjani tal-vitamina E, ALA, aċidu linolejku, EPA, DHA, u aċidu arakidoniku fis-serum naqsu mil-linja bażi għall-Ġimgħa 26 imma baqgħu 'l fuq mill-aktar limitu baxx tal-medda ta' referenza.
English: LOWER registry - long term prospective observational study to systematically collect information on the safety and effectiveness outcomes of patients treated with lomitapide.
Maltese: Reġistru LOWER - studju osservazzjonali prospettiv fuq tul ta' żmien biex tinġabar l-informazzjoni b'mod sistematiku dwar ir-riżultati tassigurtà u l-effettività ta' pazjenti ttrattati b'lomitapide.
English: Haematemesis
Maltese: Nasofarinġite
English: • Patient Alert Cards
Maltese: • Fuljetti għall-Pazjent
English: Rectal tenesmus
Maltese: Rektum tenesmus Aerophagia
English: • The capsule shell for the 30 mg capsule contains gelatin, titanium dioxide (E171), red iron oxide
Maltese: • Il-qoxra tal-kapsula għall-kapsuli ta' 30 mg fiha l-ġelatina, titanium dioxide (E171) red iron oxide (E172) u yellow iron oxide (E172).
English: EMA/32946/2017 EMEA/H/C/002677
Maltese: EMEA/32946/2017 EMEA/H/C/002677
English: Jardiance contains the active substance empagliflozin.
Maltese: Jariance fih is-sustanza attiva empagliflozin.
English: The full EPAR and risk management plan summary for Jardiance 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: This summary was last updated in 01-2017.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f'01-2017.
English: In those receiving Jardiance, cardiovascular events occurred in 10.5% (490 out of 4,687) of patients compared with 12.1% (282 out of 2,333) of patients receiving placebo.
Maltese: F'dawk li kienu qed jingħataw Jardiance, l-avvenimenti kardjovaskulari seħħew f'10.5% (490 minn 4,687) tal-pazjenti meta mqabbla ma' 12.1% (282 minn 2,333) tal-pazjenti li ngħataw il-plaċebo.
English: Other information about Jardiance
Maltese: Informazzjoni oħra dwar Jardiance
English: All the studies showed a modest but clinically meaningful decrease in HbA1c with Jardiance compared with placebo: in the study investigating use of Jardiance without other medicines, the reduction in HbA1c was 0.74% more than placebo with the 10 mg dose and 0.85% more than placebo with the 25 mg dose.
Maltese: L-istudji kollha wrew tnaqqis modest iżda klinikament sinifikanti fl-HbA1c b'Jardiance meta mqabbel mal-plaċebo: fl-istudju li investiga l-użu ta' Jardiance mingħajr mediċini oħra, it-tnaqqis fl-HbA1c kien 0.74% aktar mill-plaċebo bid-doża ta' 10 mg u 0.85% aktar mill-plaċebo bid-doża ta' 25 mg.
English: This is a summary of the European public assessment report (EPAR) for Jardiance.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Jardiance.
English: The active substance in Jardiance, empagliflozin, works by blocking a protein in the kidneys called sodium-glucose co-transporter 2 (SGLT2).
Maltese: Is-sustanza attiva f'Jardiance, l-empagliflozin, taħdem billi timblokka proteina fil-kliewi msejħa kotrasportatur tal-glukożju tas-sodju 2 (SGLT2).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Jardiance on 22 May 2014.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Jardiance fit-22 ta' Mejju 2014.
English: Why is Jardiance approved?
Maltese: Għaliex ġie approvat Jardiance?
English: What are the risks associated with Jardiance?
Maltese: X'inhuma r-riskji assoċjati ma' Jardiance?
English: Modest but clinically meaningful reductions in HbA1c were also seen when Jardiance was added to other medicines.
Maltese: Tnaqqis modest iżda klinikament sinifikanti fl-HbA1c deher ukoll meta Jardiance żdied ma' mediċini oħra.
English: EPAR summary for the public
Maltese: Sommarju tal-EPAR għall-pubbliku empagliflozin
English: Jardiance is available as tablets (10 and 25 mg) and can only be obtained with a prescription.
Maltese: Jardiance jiġi bħala pilloli (10 u 25 mg) u jista' jinkiseb biss b'riċetta ta' tabib.
English: There was also supportive evidence suggesting benefit when the medicine was combined with insulin.
Maltese: Kien hemm ukoll evidenza ta' appoġġ li tissuġġerixxi benefiċċju meta l-mediċina ġiet ikkombinata mal-insulina.
English: Jardiance can be used on its own in patients who cannot take metformin (another diabetes medicine).
Maltese: Jardiance jista' jintuża waħdu f'pazjenti li ma jistgħux jieħdu metformina (mediċina oħra kontra ddijabete).
English: On average, patients in the study were followed up for 3.1 years.
Maltese: Bħala medja, il-pazjenti fl-istudju ġew segwiti għal 3.1 snin.
English: If Jardiance is used in combination with insulin or sulphonylureas (medicines that make the body produce insulin), the doses of these may need to be reduced to decrease the risk of hypoglycaemia (low blood sugar levels).
Maltese: Jekk Jardiance jintuża f'kombinazzjoni mal-insulina jew ma' sulfonilureas (mediċini li jagħmlu l-ġisem jipproduċi l-insulina), jista' jkun hemm bżonn li d-dożi ta' dawn jitnaqqsu sabiex jitnaqqas ir-riskju ta' ipogliċemija (livelli baxxi ta' zokkor fid-demm).
English: Jardiance was also shown to reduce cardiovascular events in patients with type 2 diabetes who already had cardiovascular disease.
Maltese: Jardiance deher ukoll li jnaqqas avvenimenti kardjovaskulari f'pazjenti bid-dijabete tat-tip 2 li kienu jsofru diġà minn mard kardjovaskulari.
English: Jardiance was compared with placebo (a dummy treatment) when used alone or added to treatment with other diabetes medicines (metformin, pioglitazone, or metformin plus either pioglitazone or another type of diabetes medicine called a sulphonylurea).
Maltese: Jardiance tqabbel ma' plaċebo (kura finta) meta użat waħdu jew miżjud ma' kura b'mediċini oħra kontra d-dijabete (metformina, pioglitazone, jew metformina flimkien ma' jew pioglitazone jew tip ieħor ta' mediċina kontra d-dijabete msejħa sulfonilurea).
English: Jardiance empagliflozin
Maltese: Kif jintuża Jardiance?
English: Jardiance is a diabetes medicine used with diet and exercise to treat adults whose type 2 diabetes is not satisfactorily controlled.
Maltese: Jardiance huwa mediċina kontra d-dijabete użata flimkien ma' dieta u eżerċizzju għall-kura ta' adulti li d-dijabite tat-tip 2 tagħhom ma tkunx ikkontrollata b'mod sodisfaċenti.
English: Because Jardiance relies on the working of the kidneys for its effect, treatment with this medicine is not recommended in patients with moderately or severely impaired kidney function.
Maltese: Peress li Jardiance jiddependi mill-ħidma tal-kliewi għall-effett tiegħu, il-kura b'din il-mediċina mhijiex rakkomandata f'pazjenti li għandhom funzjoni talkliewi indebolita moderatament jew severament.
English: concluded that Jardiance was shown to be effective in lowering blood glucose levels in patients with type 2 diabetes, when given alone or in combination with other diabetes medicines with different mechanisms of action.
Maltese: Is-CHMP ikkonkluda li Jardiance ntwera li huwa effikaċi biex ibaxxi l-livelli ta' glukożju fid-demm f'pazjenti b'dijabete tat-tip 2, meta mogħti waħdu jew f'kombinazzjoni ma' mediċini oħra kontra d-dijabete b'mekkaniżmi ta' azzjoni differenti.
English: The most common side effect with Jardiance (which may affect more than 1 in 10 people) is hypoglycaemia (low blood sugar) when the medicine is taken with a sulphonylurea or insulin.
Maltese: L-effetti sekondarji l-aktar komuni b'Jardiance (li jistgħu jaffettwaw aktar minn persuna 1 minn kull 10) huma ipogliċemija (zokkor baxx fid-demm) meta l-mediċina tittieħed ma' sulfonilurea jew mal-insulina.
English: How is Jardiance used?
Maltese: Kif jaħdem Jardiance?
English: By blocking the action of SGLT2, empagliflozin causes more glucose to be removed via the kidney, through the urine, thereby reducing the levels of glucose in the blood.
Maltese: Billi timblokka l-azzjoni ta' SGLT2, l-empagliflozin twassal biex aktar glukożju jitneħħa permezz tal-kliewi, mal-urina, b'hekk jitnaqqsu l-livelli ta' glukożju fid-demm.
English: Regarding safety, overall the side effects were considered manageable.
Maltese: Fir-rigward tas-sigurtà, b'mod ġenerali, l-effetti sekondarji ġew ikkunsidrati bħala maniġġabbli.
English: The recommended starting dose is 10 mg once a day, which can be increased if necessary to 25 mg daily in suitable patients.
Maltese: Id-doża rakkomandata tal-bidu hija 10 mg darba kuljum, li tista' tiżdied jekk ikun hemm bżonn għal 25 mg kuljum f'pazjenti xierqa.
English: West Sussex, RH12 5AB United Kingdom
Maltese: West Sussex, RH12 5AB
English: * See section 4.4 Photosensitivity
Maltese: * Ara sezzjoni 4.4 Fotosensittività
English: Pressor amines (e.g. noradrenaline, adrenaline)
Maltese: Pressor amines (eż. noradrenalina, adrenalina)
English: MedDRA System Organ Class
Maltese: Sistema talKlassifika talOrgani MedDRA
English: Systemic lupus erythematosus
Maltese: Lupus erythematosus sistemiku
English: Hypromellose Macrogol 4000
Maltese: Makrogol 4000
English: Alcohol, barbiturates or narcotics
Maltese: Alkoħol, barbiturati u narkotiċi
English: PVC/PVDC blisters.
Maltese: Folji tal-PVC/PVDC.
English: Hypromellose Titanium dioxide (E171) Macrogol 4000
Maltese: Dijossidu tat-titanju (E171) Makrogol 4000
English: D-90429 Nuremberg Germany
Maltese: D-90429 Nuremberg Il-Ġermanja
English: • fever (pyrexia)
Maltese: • deni (piressija)
English: Respiratory distress, pulmonary oedema, pneumonitis
Maltese: Distress respiratorju, edima fil-pulmuni, pulmonite
English: Absolute bioavailability has been calculated as between 64% and 80%.
Maltese: Il-bijodisponibbiltà assoluta kienet ikkalkulata bejn 64% u 80%.
English: • impotence
Maltese: • impotenza
English: Hydrochlorothiazide
Maltese: Hydrochlorthiazide
English: Novartis Pharma GmbH Roonstrasse 25
Maltese: Novartis Pharma GmbH Roonstraße 25
English: Photosensitivity
Maltese: Fotosensittività
English: Pack sizes: 14, 28, 30, 56, 90, 98 or 280 film-coated tablets.
Maltese: Daqsijiet tal-pakketti: 14, 28, 30, 56, 90, 98 jew 280 pillola miksija b'rita.
English: Arrhythmias (including bradycardia, ventricular tachycardia, and atrial fibrillation)
Maltese: Arritmiji (inkluż bradikardija, takikardija talventrikulu, u fibrillazzjoni tal-atriju)
English: Renal artery stenosis
Maltese: Stenożi tal-arterja renali
English: See section 4.2 for information on paediatric use.
Maltese: Ara sezzjoni 4.2 għal informazzjoni fuq l-użu pedjatriku.
English: Amlodipine Grapefruit or grapefruit juice
Maltese: Amlodipine Grejpfrut jew meraq tal-grejpfrut
English: Other metabolic disturbances
Maltese: Disturbi metaboliċi oħra
English: Medicinal products used in the treatment of gout (probenecid, sulfinpyrazone and allopurinol)
Maltese: Prodotti mediċinali użati fil-kura tal-gotta (probenecid, sulfinpyrazone u allopurinol)
English: Not known Rare
Maltese: Rari ħafna
English: CYP3A4 inducers (anticonvulsant agents [e.g. carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone], rifampicin, Hypericum perforatum [St. John's wort])
Maltese: (sustanzi kontra lkonvulżjonijiet [eż. karbamazepina, fenobarbital, phenytoin, fosphenytoin, primidon], rifampiċin, Hypericum perforatum [St. John's wort])
English: • palpitations
Maltese: • palpitazzjonijiet
English: Mean absolute bioavailability is 23%.
Maltese: Il-medja tal-bijodisponibbiltà assoluta hija ta' 23%.
English: Non-steroidal antiinflammatory medicines (NSAIDs), including selective cyclooxygenase-2 inhibitors (COX-2 inhibitors), acetylsalicylic acid (>3 g/day), and nonselective NSAIDs
Maltese: Mediċini antiinfjammatorji mhux sterojdi (NSAIDs), inklużi inibituri selettivi cyclooxygenase-2 (inibituri COX-2), aċidu aċetilsaliċiliku (>3 g/jum), u NSAIDs mhux selettivi
English: Valsartan Others (cimetidine, warfarin, furosemide, digoxin, atenolol, indometacin, hydrochlorothiazide, amlodipine, glibenclamide)
Maltese: Valsartan Oħrajn (ċimetidina, warfarin, furosemide, digoxin, atenolol, indometacin, hydrochlorthiazide, amlodipine, glibenclamide)
English: Severe renal impairment (GFR <30 ml/min/1.73 m2), anuria and patients undergoing dialysis.
Maltese: Indeboliment renali qawwi (GFR <30 ml/min/1.73 m2), anurija u pazjenti b'dijalisi.
English: (calculations assume an oral dose of 320 mg/day and a 60-kg patient).
Maltese: (kalkulazzjonijet jassumu doża orali ta' 320 mg/kuljum u pazjent ta' 60-kg).
English: Manufacturer Novartis Pharma GmbH Roonstraße 25
Maltese: Il-Manifattur Novartis Pharma GmbH Roonstraße 25
English: Cases of photosensitivity reactions have been reported with thiazide diuretics (see section 4.8).
Maltese: Każijiet ta' reazzjonijiet ta' fotosensittività kienu rrappurtati b'dijuretiċi thiazide (ara sezzjoni 4.8).
English: Valsartan is highly bound to serum proteins (94-97%), mainly serum albumin.
Maltese: Valsartan jintrabat b'mod qawwi mal-proteini tas-serum (94-97%), l-aktar mal-albumina tas-serum.
English: Frequency Imprida HCT
Maltese: Frekwenza Imprida HCT
English: Very common: ≥1/10; common: ≥1/100 to <1/10; uncommon: ≥1/1,000 to <1/100; rare: ≥1/10,000 to <1/1,000; very rare: <1/10,000, not known (cannot be estimated from the available data).
Maltese: Komuni ħafna: ≥1/10; komuni: ≥1/100 sa <1/10; mhux komuni: ≥1/1,000 sa <1/100; rari:
English: Valsartan Inhibitors of the uptake transporter (rifampicin, ciclosporin) or efflux transporter (ritonavir)
Maltese: Valsartan Inibituri tattrasportatur tat-teħid (rifampicin, ciclosporin) jew trasportatur tal-effluss (ritonavir)
English: Hyperlipidaemia
Maltese: Iperlipidimija
English: Vitamin D and calcium salts
Maltese: Vitamina D u mluħa tal-kalċju
English: Hydrochlorothiazide belongs to a group of substances called “thiazide diuretics”.
Maltese: Hydrochlorthiazide jagħmel parti minn grupp ta' sustanzi msejħa “dijuretiċi thiazide”.
English: Distribution: Volume of distribution is approximately 21 l/kg.
Maltese: Il-volum ta' distribuzzjoni huwa ta' madwar 21 l/kg.
English: Similar outcomes have been reported with valsartan.
Maltese: Konsegwenzi simili kienu rrappurtati b'valsartan.
English: • abnormal coordination
Maltese: • koordinazzjoni mhux normali
English: Amantadine
Maltese: Amantadina
English: Linearity Amlodipine, valsartan and hydrochlorothiazide exhibit linear pharmacokinetics.
Maltese: Linearità Amlodipine, valsartan u hydrochlorthiazide għandhom farmakokinetiċi lineari.
English: Pharmacotherapeutic group: Angiotensin II antagonists, plain (valsartan), combinations with dihydropyridine derivatives (amlodipine) and thiazide diuretics (hydrochlorothiazide), ATC code: C09DX01 valsartan, amlodipine and hydrochlorothiazide.
Maltese: Antagonisti ta' anġjotensin II, sempliċi (valsartan), kumbinazzjonijiet ma' derivati ta' diidropiridina (amlodipine), u dijuretiċi thiazide (hydrochlorthiazide), Kodiċi ATC: C09DX01 valsartan, amlodipine u hydrochlorthiazide.
English: Information on Imprida HCT
Maltese: Informazzjoni dwar Imprida HCT
English: Imprida HCT is available in packs containing 14, 28, 30, 56, 90, 98 or 280 film-coated tablets, in multipacks of 280 tablets (comprising 4 cartons, each containing 70 tablets, or 20 cartons, each containing 14 tablets), and in hospital packs containing 56, 98 or 280 tablets in single unit blisters.
Maltese: Imprida HCT huwa disponibbli f'pakketti li fihom 14, 28, 30, 56, 90, 98 jew 280 pillola miksija b'rita, f'pakketti multipli ta' 280 pillola (magħmulin minn 4 kartuniet, li kull waħda minnhom fiha 70 pillola, jew 20 kartuna, li kull waħda minnhom fiha 14-il pillola), u f'pakketti tal-isptar li fihom 56, 98 jew 280 pillola f'folji bid-dożi ppakkjati waħda waħda.
English: Due to the hydrochlorothiazide component, Imprida HCT is contraindicated for use in patients with anuria (see section 4.3) and in patients with severe renal impairment (glomerular filtration rate (GFR) <30 ml/min/1.73 m2) (see sections 4.3, 4.4 and 5.2).
Maltese: Minħabba l-komponent hydrochlorthiazide, Imprida HCT huwa kontraindikat għall-użu f'pazjenti b'nuqqas ta' produzzjoni ta' awrina (ara sezzjoni 4.3) u f'pazjenti b'indeboliment renali sever (rata tal-filtrazzjoni fil-glomeruli (GFR)<30 ml/min/1.73 m2) (ara sezzjonijiet 4.3, 4.4 u 5.2).
English: Valsartan belongs to a group of substances called “angiotensin-II receptor antagonists”.
Maltese: Valsartan huwa membru ta' grupp ta' sustanzi li jissejħu “antagonisti tar-riċetturi ta' anġjotensin II”.
English: Cellulose microcrystalline Crospovidone Silica, colloidal anhydrous Magnesium stearate
Maltese: Qalba tal-pillola Ċelluloża mikrokristallina Krospovidon Silica, colloidal anhyrous Stearat tal-manjesju
English: The active substances of Imprida HCT are amlodipine (as amlodipine besylate), valsartan and hydrochlorothiazide.
Maltese: Is-sustanzi attivi ta' Imprida HCT huma amlodipine (bħala amlodipine besylate), valsartan u hydrochlorthiazide.
English: Valsartan and HCT
Maltese: Valsartan u HCT
English: Distribution: The apparent volume of distribution is 4-8 l/kg.
Maltese: Il-volum ta' distribuzzjoni li jidher huwa ta' 4-8 l/kg.
English: Steady-state plasma levels are reached after continuous administration for 7-8 days.
Maltese: Il-livelli fil-plażma jilħqu stat fiss wara l-għotja kontinwa ta' 7-8 ijiem.
English: In vitro studies with amlodipine have shown that approximately 97.5% of circulating drug is bound to plasma proteins.
Maltese: Studji in vitro b'amlodipine wrew li madwar 97.5% tal-mediċina li tkun qed tiċċirkola tintrabat mal-proteini tal-plażma.
English: Refractory hypokalaemia, hyponatraemia, hypercalcaemia, and symptomatic hyperuricaemia.
Maltese: Ipokalimja refrattorja, iponatrimija, iperkalċimija, u iperuriċemija sintomatika.
English: The half-life of valsartan is 6 hours.
Maltese: Il-half-life ta' valsartan hija ta' 6 sigħat.
English: Methyldopa
Maltese: Metildopa
English: Biotransformation: Amlodipine is extensively (approximately 90%) metabolised in the liver to inactive metabolites.
Maltese: L-amlodipine hija metabolizzata b'mod estensiv (madwar 90%) fil-fwied għal metaboli inattivi.
English: Amlodipine CYP3A4 inhibitors (i.e. ketoconazole, itraconazole, ritonavir)
Maltese: (i.e. ketoconazole, itraconazole, ritonavir)
English: Second and third trimesters of pregnancy (see sections 4.4 and 4.6).
Maltese: It-tieni u t-tielet trimestri tat-tqala (ara sezzjonijiet 4.4 u 4.6).
English: St. John's wort; dantrolene (infusion for severe body temperature abnormalities); vitamin D and calcium salts.
Maltese: • dantrolene (infużjoni għal anormalitajiet severi fit-temperatura tal-ġisem); vitamina D u mluħa tal-kalċju.
English: Carcinogenesis, mutagenesis
Maltese: Karċinoġenesi, mutaġenesi
English: Amlodipine Common
Maltese: Amlodipine Komuni
English: Haemolytic anaemia
Maltese: Anemija aplastika