FrancophonIA/ELRC3.0 huggingface dataset:
English: In post-marketing experience of saxagliptin, there have been spontaneously reported adverse reactions of acute pancreatitis.
Maltese: Fl-esperjenza wara t-tqegħid fis-suq ta' saxagliptin, kien hemm rapporti spontanji ta' reazzjonijiet avversi ta' pankreatite akuta.
English: Bioequivalence has been confirmed between the Qtern 5 mg/10 mg tablet and the individual saxagliptin 5 mg and dapagliflozin 10 mg tablets after single dose administration in the fasted state in healthy subjects.
Maltese: Il-bijoekwivalenza ġiet ikkonfermata bejn il-pillola Qtern tal-5 mg/10 mg u l-pilloli individwali saxagliptin tal-5 mg u dapagliflozin tal-10 mg wara għotja ta' doża waħda fl-istat ta' sawm f'individwi f'saħħithom.
English: - Necrotising fasciitis of the perineum or Fournier's gangrene, a serious soft tissue infection of the genitals or the area between the genitals and the anus.
Maltese: - Faxxite nekrotizzanti tal-perinew jew kankrena ta' Fournier, infezzjoni serja tat-tessut artab talġenitali jew tal-parti bejn il-ġenitali u l-anus.
English: Increased incidence or severity of renal pelvic dilatation was observed in adult offspring of treated dams, although only at the highest dose tested (at maternal and pup dapagliflozin exposures of 1415 times and 137 times, respectively, the human values at the maximum recommended human dose [MRHD]).
Maltese: Inċidenza miżjuda jew severità tat-twessigħ fil-pelvi tal-kliewi kien osservat fil-frieħ adulti ta' ommijiet ikkurati, għalkemm fl-ogħla doża ttestjata biss (f'esponimenti ta' dapagliflozin tal-omm u tal-frieħ ta' 1415-il darba u 137 darba, rispettivament, tal-valuri tal-bnedmin fid-doża massima rrakkomandata għall-bniedem [MRHD]).
English: Administration of Qtern with a high-fat meal decreases dapagliflozin Cmax by up to 35 % and prolongs Tmax by approximately 1.5 hours, but does not alter AUC as compared with the fasted state.
Maltese: L-għoti ta' Qtern ma' ikla b'kontenut għoli ta' xaħam inaqqas dapagliflozin Cmax sa 35 % u jtawwal Tmax sa bejn wieħed u ieħor 1.5 siegħat, imma ma jbiddilx l-AUC kif imqabbel mal-istat ta' sawm.
English: One patient in the saxagliptin plus dapagliflozin plus metformin group experienced an SAE of pyelonephritis and discontinued treatment.
Maltese: Pazjent wieħed fil-grupp saxagliptin kif ukoll dapagliflozin kif ukoll metformin esperjenza pjelonefrite SAE u waqqaf il-kura.
English: The no effect level (NOEL) for the lesions is 1 and 2 times the human exposure of saxagliptin and the major metabolite respectively, at the recommended human dose (RHD) of 5 mg/day.
Maltese: Il-livell ta' bla effett (NOEL) talleżjonijiet huwa darba u darbtejn l-esponiment tal-bnedmin ta' saxagliptin u l-metabolit maġġuri rispettivament, fid-doża rakkomandata għall-bnedmin (RHD) ta' 5mg/jum.
English: No benefit was observed for MACE or all-cause mortality.
Maltese: Ma ġie osservat ebda benefiċċju għal MACE jew għall-mortalità b'kull kawża.
English: (sinusitis) - inflamed nose or throat (nasopharyngitis) (signs of this may include a cold or a sore throat) - stomach ache and indigestion (dyspepsia) - nausea - diarrhoea - inflamed stomach or gut usually caused by an infection (gastroenteritis) - headache, muscle pain (myalgia) - vomiting, inflammation of the stomach (gastritis) - changes in laboratory tests (for example creatinine renal clearance decreased or haematocrit increased).
Maltese: ħakk, tnixxija mhux tas-soltu jew riħa) - uġigħ fid-dahar - tagħmel aktar ilma (awrina) mis-soltu jew ikollok bżonn tagħmel aktar ilma ta' spiss - bidliet fl-ammont ta' kolesterol jew xaħmijiet fid-demm tiegħek, (murija fit-testijiet) - żidiet fl-ammont ta' ċelloli ħomor tad-demm fid-demm tiegħek, (murija fit-testijiet) - tnaqqis fit-tneħħija tal-kreatinina mill-kliewi (kif muri fit-testijiet) - sturdament - għejja - uġigħ fl-istonku - uġigħ sever fil-ġogi (artralġja) - infezzjoni fil-parti ta' fuq tas-sider jew pulmun - infezzjoni tas-sinuses b'sensazzjoni ta' uġigħ u nefħa wara ħaddejk u għajnejk (sinusite) - imnieħer jew gerżuma fjammati (nasofarinġite) (is-sinjali ta' dan jistgħu jinkludu riħ jew uġigħ fil-ġriżmejn) - uġigħ fl-istonku jew indiġestjoni (dispepsja) - dardir - dijarea - stonku jew imsaren fjammati ġeneralment ikkawżati minn infezzjoni (gastroenterite) - uġigħ ta' ras, uġigħ fil-muskoli (mijalġja) - rimettar, fjammazzjoni tal-istonku (gastrite) - bidliet fit-testijiet fil-laboratorju (pereżempju tnaqqis fl-eliminazzjoni tal-krejatinina fil-kliewi jew żieda fl-ematokrit) - raxx
English: Dyslipidaemia includes the following preferred terms: dyslipidaemia, hyperlipidaemia, hypercholesterolaemia, and hypertriglyceridaemia.
Maltese: Dislipidemija tinkludi t-termini ppreferuti li ġejjin: dislipidemija, iperlipidimja, iperkolesterolemija, u ipertrigliċeridimija.
English: Mon. Tue. Wed. Thu. Fri. Sat. Sun.
Maltese: Jekk mintix ċert, kellem lit-tabib, lill-ispiżjar, jew l-infermier tiegħek qabel ma tieħu Qtern.
English: The same recommendations for monitoring of renal function apply to elderly patients as to all patients (see sections 4.2, 4.4, 4.8, and 5.1).
Maltese: L-istess rakkomandazzjonijiet għall-monitoraġġ tal-funzjoni tal-kliewi japplikaw kemm għall-pazjenti anzjani kif ukoll għall-pazjenti kollha (ara sezzjonijiet 4.2, 4.4, 4.8, u 5.1).
English: The risk of diabetic ketoacidosis must be considered in the event of non-specific symptoms such as nausea, vomiting, anorexia, abdominal pain, excessive thirst, difficulty breathing, confusion, unusual fatigue or sleepiness.
Maltese: Ir-riskju ta' ketoaċidożi dijabetika għandu jitqies fil-każ ta' sintomi mhux speċifiċi bħal dardir, rimettar, anorexja, uġigħ addominali, għatx eċċessiv, diffikultà biex jittieħed in-nifs, konfużjoni, għeja mhux tas-soltu u ngħas.
English: gastritis
Maltese: Dijuretiċi
English: Dermatitis
Maltese: Dislipidemija
English: Treatment with SGLT2 inhibitors increases the risk for urinary tract infections.
Maltese: Il-kura bl-inibituri SGLT2 iżid ir-riskju ta' infezzjonijiet fl-apparat tal-awrina.
English: Saxagliptin/dapagliflozin combination: Malignant and unspecified neoplasms were reported in 3 subjects included in the pooled safety data.
Maltese: Neoplażmi malinni u mhux speċifikati kienu rrapportati fi 3 individwi inklużi fid-data tas-sigurtà miġbura.
English: Females had approximately 25% higher systemic-exposure values for saxagliptin, this difference is considered not clinically relevant.
Maltese: In-nisa kellhom bejn wieħed u ieħor il-valuri tal-esponiment sistemiku ta' saxagliptin 25% ogħla, din id-differenza hija meqjusa bħala mhux klinikament rilevanti.
English: Ulcerative and necrotic skin lesions have been reported in extremities of monkeys in non-clinical toxicology studies with saxagliptin (see section 5.3).
Maltese: Ġew irrapportati leżjonijiet tal-ġilda ulċerattivi u nekrotiċi fl-estremitajiet tax-xadini fi studji tossikoloġiċi mhux kliniċi b'saxagliptin (ara sezzjoni 5.3).
English: The removal of dapagliflozin by haemodialysis has not been studied.
Maltese: It-tneħħija ta' dapagliflozin permezz tal-emodijalisi ma ġietx studjata.
English: Change from baseline (adjusted mean (95 % CI)
Maltese: Bidla mil-linja bażi (medja aġġustata (95 % CI)
English: Creatinine renal clearance decreased haematocrit increased
Maltese: KONDIZZJONIJIET JEW RESTRIZZJONIJIET FIR-RIGWARD TALUŻU SIGUR U EFFIKAĊI TAL-PRODOTT MEDIĊINALI
English: Rash was reported during the postmarketing use of saxagliptin and dapagliflozin.
Maltese: Avvenimenti relatati ma' tnaqqis fil-funzjoni tal-kliewi Kombinament saxagliptin/dapagliflozin:
English: Saxagliptin/dapagliflozin combination: The incidence of hypoglycaemia was low (1.4 %) in the saxagliptin plus dapagliflozin plus metformin group, 0.3 % in the saxagliptin plus metformin group, and 1.8 % in the dapagliflozin plus metformin group.
Maltese: L-inċidenza tal-ipogliċemija kienet baxxa (1.4%) fil-grupp ta' saxagliptin kif ukoll f'dak ta' dapagliflozin kif ukoll metformin, 0.3% fil-grupp ta' saxagliptin kif ukoll metformin, u fil-grupp ta' dapagliflozin kif ukoll metformin.
English: This overview was last updated in November 2018.
Maltese: Din il-ħarsa ġenerali ġiet aġġornata l-aħħar f'Novembru 2018.
English: Further information on Syvazul BTV can be found on the Agency's website: ema.europa.eu/medicines/veterinary/EPAR/syvazul-btv.
Maltese: ema.europa.eu/medicines/veterinary/EPAR/syvazul-btv.
English: Syvazul BTV received a marketing authorisation valid throughout the EU on 9 January 2019.
Maltese: Syvazul BTV ingħata awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE fi 09/01/2019.
English: The most common side effects with Syvazul BTV (which may affect more than 1 in 10 animals) are local injection site reactions, erythema (reddening of the skin) with mild to moderate swelling 1 to 6 days after vaccination, a painless nodule (up to 3.8 cm diameter in sheep and 7 cm diameter in cattle) 2 to 6 days after vaccination and a short-lived increase in body temperature of no more than 2.3˚C in the 48 hours after vaccination.
Maltese: L-effetti sekondarji l-aktar komuni b'Syvazul BTV (li jista' jaffettwa aktar minn annimal 1 minn kull 10) huma reazzjonijiet lokali fis-sit tal-injezzjoni, eritema (ħmura tal-ġilda) b'nefħa ħafifa sa moderata minn 1 sa 6 ijiem wara t-tilqim, nodulu mingħajr uġigħ (b'dijametru sa 3.8 cm fin-nagħaġ u b'dijametru ta' 7 cm fl-ifrat) 2 sa 6 ijiem wara t-tilqim u żieda għal żmien qasir fit-temperatura talġisem ta' mhux aktar minn 2.3 °C fit-48 siegħa wara t-tilqim.
English: Other information about Syvazul BTV
Maltese: Informazzjoni oħra dwar Syvazul BTV
English: The vaccine also contains ‘adjuvants' (aluminium hydroxide and saponin) that enhance the response of the immune system.
Maltese: Il-vaċċin fih ukoll “adjuvanti” (idrossidu tal-aluminju u saponina) li jtejbu r-rispons tas-sistema immunitarja.
English: Groups of 25 calves from 2 months of age (with no antibodies to bluetongue virus) were vaccinated with vaccines containing BTV-1, BTV-8 and BTV 1+8 in a field study.
Maltese: Gruppi ta' 35 għoġol mill-età ta' xahrejn (2) (mingħajr antikorpi tal-virus tal-ilsien blu) tlaqqmu b'vaċċini li fihom BTV-1, BTV-8 u BTV 1+8 fi studju fuq ilpost.
English: The vaccine contains inactivated (killed) bluetongue viruses.
Maltese: Il-vaċċin fih il-viruses inattivati (maqtula) tal-marda tal-ilsien blu.
English: Syvazul BTV contains bluetongue virus of one or two types selected from serotypes 1, 4 and 8.
Maltese: Syvazul BTV fih il-virus tal-ilsien blu ta' tip wieħed jew tnejn magħżula mis-serotipi 1,4 u 8.
English: In a field study, 3 groups of 35 lambs from 3 months of age (with no antibodies to bluetongue virus) received vaccination with vaccines containing BTV-1, BTV-8 and BTV 1+8.
Maltese: Fi studju fuq il-post, 3 gruppi ta' 35 ħaruf mill-età ta' 3 xhur (mingħajr antikorpi tal-virus tal-ilsien blu) tlaqqmu b'vaċċini li fihom BTV-1, BTV-8 u BTV 1+8.
English: Syvazul BTV is a vaccine.
Maltese: Syvazul BTV huwa vaċċin.
English: People who are hypersensitive (allergic) to aluminium hydroxide, thiomersal or saponins should avoid contact with Syvazul BTV.
Maltese: Persuni li huma ipersensittivi (allerġiċi) għall-idrossidu tal-aluminju, it-tijomersal jew is-saponins għandhom jevitaw il-kuntatt ma' Syvazul BTV.
English: Effectiveness was measured by comparing antibody levels to the virus at days 35 and 63 after vaccination with levels from laboratory studies.
Maltese: L-effikaċja tkejlet permezz tat-tqabbil tal-livelli tal-antikorpi għall-virus f'jiem 35 u 63 wara t-tilqim b'livelli minn studji fil-laboratorju.
English: What are the risks associated with Syvazul BTV?
Maltese: X'inhuma r-riskji assoċjati ma' Syvazul BTV?
English: For the full list of side effects and restrictions of Syvazul BTV, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet ta' Syvazul BTV, ara l-fuljett ta' tagħrif.
English: Laboratory studies were conducted in which sheep and cattle vaccinated with Syvazul BTV were exposed to BTV serotype 1, 4 or 8.
Maltese: Saru studji fil-laboratorju fejn nagħaġ u frat imlaqqma b'Syvazul BTV kienu esposti għas-serotip talBTV 1, 4 jew 8.
English: Why is Syvazul BTV authorised in the EU?
Maltese: Għaliex Syvazul BTV huwa awtorizzat fl-UE?
English: The data showed that antibody levels at day 63 after vaccination for each group remained at levels similar to day 35 after vaccination and above levels from the laboratory studies.
Maltese: Id-data wriet li l-livelli ta' antikorpi fil-jum 63 wara t-tilqim għal kull grupp baqgħu f'livelli simili għall-jum 35 wara t-tilqim u ‘l fuq mil-livelli mill-istudji fil-laboratorju.
English: The data showed that antibody levels at day 42 after vaccination for each group remained at levels similar to day 21 after vaccination and above levels from the laboratory studies.
Maltese: Id-data wriet li l-livelli ta' antikorpi fil-jum 42 wara t-tilqim għal kull grupp baqgħu f'livelli simili għall-jum 21 wara t-tilqim u ‘l fuq mil-livelli mill-istudji fillaboratorju.
English: Effectiveness was measured by comparing antibody levels at 21 and 42 days after completing the initial vaccination course with levels from laboratory studies.
Maltese: L-effikaċja tkejlet permezz tat-tqabbil tal-livelli tal-antikorpi għall-virus f'jiem 21 u 42 wara l-kors tal-bidu ta' tilqim b'livelli minn studji fil-laboratorju.
English: Syvazul BTV is a vaccine used in sheep and cattle to protect them against bluetongue disease, an infection caused by the bluetongue virus which is transmitted by midges.
Maltese: Syvazul BTV huwa vaċċin li jintuża fin-nagħaġ u fil-frat biex jipproteġihom kontra l-marda tal-ilsien blu, infezzjoni kkawżata mill-virus tal-ilsien blu li jiġi trażmess mill-insetti dipteri.
English: How does Syvazul BTV work?
Maltese: Kif jintuża Syvazul BTV?
English: Safety information has been included in the summary of product characteristics and the package leaflet for Syvazul BTV, including the appropriate precautions to be followed by healthcare professionals and animal owners or keepers.
Maltese: Fis-sommarju tal-karatteristiċi tal-prodott u l-fuljett ta' tagħrif ġiet inkluża informazzjoni rigward issigurtà ta' Syvazul BTV, inkluż il-prekawzjonijiet xierqa li għandhom ikunu segwiti mill-professjonisti fil-qasam tal-kura tas-saħħa u mis-sidien tal-annimali jew dawk li jieħdu ħsiebhom.
English: The vaccine is given as two injections into a muscle to calves from 2 months of age if the calves have no immunity to bluetongue virus or from 3 months of age in calves born to mothers already immune to the disease.
Maltese: Il-vaċċin jingħata bħala żewġ injezzjonijiet f'muskolu għall-għoġġiela mill-età ta' xahrejn (2) jekk lgħoġġiela ma jkollhomx immunità għall-virus tal-ilsien blu jew mill-età ta' 3 xhur f'għoġġiela mwielda minn ommijiet li diġà huma immuni għall-marda.
English: Laboratory studies showed that in cattle the vaccine starts to be effective 21 days after completion of the initial vaccination course and protection lasts one year.
Maltese: L-istudji fil-laboratorju wrew li fl-ifrat il-vaċċin jibda jkun effettiv 21 jum wara li jitlesta l-kors tal-bidu ta' tilqim u l-protezzjoni ddum għal sena (1).
English: When it is given to sheep and cattle, the animals' immune systems recognise the viruses as ‘foreign' and make antibodies against them.
Maltese: Meta jingħata lin-nagħaġ u lill-frat, issistemi immunitarji tal-annimali jagħrfu l-viruses bħala “barranin” u jagħmlu antikorpi kontrihom.
English: Absolute oral bioavailability is estimated to be 72%.
Maltese: Il-biodisponibilità orali assoluta hija stimata li hi 72 %.
English: Via Provinciale Schito, 131 I-80058 Torre Annunziata - Napoli Italy
Maltese: Via Provinciale Schito, 131 I-80058 Torre Annunziata - Napoli L-Italja
English: Trazec contains lactose monohydrate.
Maltese: Trazec fih lactose monohydrate.
English: • Type 1 diabetes (insulin-dependent diabetes mellitus, C-peptide negative)
Maltese: • Dijabete Tip 1 (Dijabete mellitus dipendenti fuq l-insulina, C-peptajd negattiv)
English: The tablet coating contains hypromellose; titanium dioxide (E171); talc; macrogol and red (60 and 180 mg tablets) or yellow (120 mg tablets) iron oxide (E172).
Maltese: - Il-pillola fiha hypromellose; titanium dioxide (E171); talc; macrogol and red (60 and 180 mg tablets) or yellow (120 mg tablets) iron oxide (E172).
English: Frequencies are defined as: common (>1/100, <1/10); uncommon (>1/1,000, <1/100); rare (>1/10,000, <1/1,000); very rare (<1/10,000).
Maltese: Il-frekwenzi huma definiti bħala: komuni (>1/100, <1/10); mhux komuni (>1/1,000, <1/100); rari (>1/10,000, <1/1,000); rari ħafna (<1/10,000).
English: DATE OF FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION Date of first authorisation: 03.04.2001
Maltese: DATA TA' L-EWWEL AWTORIZZAZZJONI/TIĠDID TA' L-AWTORIZZAZZJONI Data ta' l-ewwel awtorizzazzjoni: 03.04.2001
English: Packs contain 12, 60, 84, 120 and 360 tablets.
Maltese: Pakketti li fihom 12, 60, 84, 120 u 360 pillola.
English: Lactose monohydrate: 141.5 mg per tablet.
Maltese: Lactose monohydrate: 141.5 mg għal kull pillola.
English: Nateglinide is extensively metabolised.
Maltese: Nateglinide huwa metabolizzat b'mod estensiv.
English: Nateglinide is an amino acid (phenylalanine) derivative, which is chemically and pharmacologically distinct from other antidiabetic agents.
Maltese: Nateglinide huwa derivat ta' amino aċidu (phenylalanine), li huwa kimikament u farmakoloġikament distint minn aġenti antidijabetiċi oħra.
English: Pharmacotherapeutic group: D-phenylalanine derivative, ATC code: A10 BX 03
Maltese: Derivat ta' D-phenylalanine, Kodiċi ATC:
English: Trazec 60 mgfilm-coated tablets Trazec 120 mg film-coated tablets Trazec 180 mg film-coated tablets Nateglinide
Maltese: Trazec 60 mg pilloli miksija b'rita Trazec 120 mg pilloli miksija b'rita Trazec 180 mg pilloli miksija b'rita Nateglimide
English: Minor metabolites identified were a diol, an isopropene and acyl glucuronide(s) of nateglinide; only the isopropene minor metabolite possesses activity, which is almost as potent as nateglinide.
Maltese: Metaboli minuri identifikati huma diol, isopropene u acyl glucuronide(s) ta' nateglinide; il-metabolu minuri isopropene biss għandu xi attività, li hija b'saħħitha kważi daqs dik ta' nateglinide.
English: Nateglinide efficacy was inferior to that of metformin in monotherapy (decrease in HbA1c (%) with metformin 500 mg three times daily monotherapy: -1.23 [95% CI: -1.48; -0.99] and with nateglinide 120 mg three times daily monotherapy -0.90 [95% CI: -1.14; -0.66]).
Maltese: L-effikaċja ta' nateglinide kienet anqas minn dik ta' metformin f'monoterapija (tnaqqis ta' HbA1c (%) b'metformin 500 mg tlett darbiet kuljum b'monoterapija: -1.23 [95% CI: -1.48; -0.99] u b'nateglinide 120 mg tlett darbiet kuljum b'monoterapija -0.90
English: • Pregnancy and breast-feeding (see section 4.6)
Maltese: • Tqala u treddigħ (ara sezzjoni 4.6)
English: In vitro studies show that nateglinide is extensively bound (97-99%) to serum proteins, mainly serum albumin and to a lesser extent alpha1-acid glycoprotein.
Maltese: Studji in vitro juru li nateglinide jeħel b'mod estensiv malproteini tas-serum (97-99 %), l-aktar ma' l-albumina tas-serum u f'ammonti iżgħar ma' l-aċidu alfa1glijkoproteina.
English: In completed clinical trials, symptoms of hypoglycaemia were reported in 10.4% with nateglinide monotherapy, 14.5% with nateglinide+metformin combination, 6.9% with metformin alone, 19.8% with glibenclamide alone,
Maltese: Fi provi kliniċi li ntemmu, sintomi ta' ipogliċemija kienu irrapurtati f'10.4 % b'monoterapija b'nateglinide, 14.5 % b'taħlita ta' nateglinide+metformin, 6.9 % b'metformin waħdu, 19.8 % b'glibenclamide waħdu, u 4.1 % bilplaċebo.
English: 6-16% of the administered dose was excreted in the urine as unchanged drug.
Maltese: 6-16 % tad-doża li ngħatat kienet imneħħija fl-awrina bħala mediċina mhux mibdula.
English: The pharmacokinetics of warfarin (a substrate for CYP3A4 and CYP2C9), diclofenac (a substrate for CYP2C9), and digoxin were unaffected by coadministration with nateglinide.
Maltese: Il-farmakokinteċi ta' warfarin (sottostrat għal CYP3A4 u CYP2C9), diclofenac (sottostrat għal CYP2C9), u digoxin ma kienux effettwati meta ingħataw ma' nateglinide.
English: Patients with renal impairment
Maltese: Indeboliment renali:
English: Interaction studies with a 3A4 inhibitor have not been carried out in vivo.
Maltese: Studji ta' interazzjoni b' impeditur 3A4 in vivo ma sarux.
English: Nateglinide has shown a low potential for protein displacement in in vitro studies.
Maltese: Nateglinide wera li ma tantx għandu ħila li jisposta l-proteina fi studji in vitro.
English: The decrease from baseline in HbA1c was -0.41% in the nateglinide plus metformin group and -0.57% in the gliclazide plus metformin group (difference 0.17%, [95% CI -0.03, 0.36]).
Maltese: It-tnaqqis mil-linja bażi f'HbA1c kien -0.41 % fil-grupp ta' nateglinide ma' metformin u -0.57 % fil-grupp ta' gliclazide ma' metformin (differenza ta' 0.
English: The other ingredients are lactose monohydrate; cellulose, microcrystalline; povidone; croscarmellose sodium; magnesium stearate and silica, colloidal anhydrous.
Maltese: croscarmellose sodium; magnesium stearate and silica, colloidal anhydrous.
English: Red iron oxide (E172) Hypromellose Titanium dioxide (E171) Talc
Maltese: Croscarmellose sodium Magnesium stearate Red iron oxide (E172) Hypromellose Titanium dioxide (E171) Talc
English: Yellow iron oxide (E172) Hypromellose Titanium dioxide (E171) Talc
Maltese: Croscarmellose sodium Magnesium stearate Yellow iron oxide (E172) Hypromellose Titanium dioxide (E171) Talc
English: The clinical experience in patients over 75 years of age is limited.
Maltese: L-esperjenza klinika f'pazjenti minn 75 sena 'l fuq hija limitata.
English: If you take more Trazec than you should
Maltese: Oqgħod attent ħafna bi Trazec
English: In vivo, nateglinide has no clinically relevant effect on the pharmacokinetics of medicinal products metabolised by CYP2C9 and CYP3A4.
Maltese: In vivo, nateglinide ma kellu l-ebda effett kliniku sinifikanti fuq il-farmakokinetiċi ta' prodotti mediċinali metabolizzati minn CYP2C9 u CYP3A4.
English: Patients with rare hereditary problems of galactose intolerance, of the Lapp lactase deficiency or of glucose-galactose malabsorption should not take this medicine.
Maltese: Pazjenti li għandhom problemi ereditarji ta' intolleranza għal galactose, tad-defiċjenza ta' Lapp lactase jew ta' malassorbiment ta' glucose-galactose m'għandhomx jieħdu din il-mediċina.
English: Blisters: PVC/PE/PVDC moulded foil with aluminium lidding foil.
Maltese: PVC/PE/PVDC fojl iffurmat b'fojl ta' aluminium li jgħatti.
English: The main metabolites found in humans result from hydroxylation of the isopropyl side-chain, either on the methine carbon, or one of the methyl groups; activity of the main metabolites is about 5-6 and 3 times less potent than nateglinide, respectively.
Maltese: Il-metaboliti prinċipali li jinstabu fil-bnedmin jirriżultaw minn idrossilazzjoni tal-katina tal-ġenb iżopropajl, jew fuq carbon methine, jew fuq wieħed mill gruppi methyl; l-attività tal-metaboli prinċipali hija ta' bejn wieħed u ieħor 5-6 u 3 darbiet inqas b'saħħitha minn nateglinide, rispettivament.
English: Rare effects are mild abnormalities in liver function tests and allergic (hypersensitivity) reactions such
Maltese: Effetti rari huma anormalitajiet fit-testijiet tal-funzjoni tal-fwied u reazzjonijiet allergiċi (sensittivita' eċċessiva) bħal raxx u ħakk.
English: 4.8 Undesirable effects
Maltese: 4.3 Kontra-indikazzjonijiet
English: Trazec and children and adolescents
Maltese: Trazec u tfal u adolexxenti
English: Early insulin secretion is a mechanism for the maintenance of normal glycaemic control.
Maltese: Il-ħelsien kmieni ta' insulina huwa mekkaniżmu biex jinżamm kontroll gliċemiku normali.
English: Excretion
Maltese: Distribuzzjoni
English: Nateglinide closes ATP-dependent potassium channels in the beta-cell membrane with characteristics that distinguish it from other sulphonylurea receptor ligands.
Maltese: Nateglinide jagħlaq kanali tal-potassium li jiddependu fuq l-ATP fir-rita ta' ċelluli beta b'karatteristiċi li jiddistingwuh minn riċetturi legati ta' sulphonylurea oħrajn.