FrancophonIA/ELRC3.0 huggingface dataset:
English: A side effect called osteonecrosis of the jaw (ONJ) (bone damage in the jaw) has been reported in the post-marketing setting in patients receiving Aclasta (zoledronic acid) for osteoporosis.
Maltese: Effett sekondarju msejjaħ osteonekrożi tax-xedaq (ONJ) (ħsara tal-għadam fix-xedaq) kien irrapportat fil-kuntest ta' wara t-tqegħid fis-suq f'pazjenti li jingħataw kura b'Aclasta (zoledronic acid) għallosteoporożi.
English: In the HORIZON-RFT study Aclasta treatment significantly increased BMD at the total hip and femoral neck relative to treatment with placebo at all timepoints.
Maltese: Fl-istudju HORIZON-RFT, il-kura b'Aclasta żiedet b'mod sinifikanti l-BMD fil-ġenb totali u fl-għonq femorali meta mqabbel mal-kura bi plaċebo fil-punti kollha taż-żmien.
English: Renal impairment has been observed following the administration of zoledronic acid, especially in patients with pre-existing renal dysfunction or additional risk factors (e.g advanced age, oncology patients with chemotherapy, concomitant nephrotoxic medicinal products, concomitant diuretic therapy, severe dehydration), with the majority of them receiving a 4 mg dose every 3-4 weeks, but it has been observed in patients after a single administration.
Maltese: Disfunzjoni renali kienet osservata wara li ngħata zoledronic acid, l-aktar f'pazjenti li kellhom disfunzjoni talkliewi minn qabel jew li kellhom xi fatturi ta' riskji oħrajn (eż. età avvanzata, pazjenti tal-onkoloġija fuq kimoterapija, l-użu konkomitanti ta' prodotti mediċinali nefrotossiċi fl-istess waqt, terapija djuretika konkomitanti, deidrazzjoni severa), li l-parti l-kbira tagħhom irċevew doża ta' 4 mg kull 3-4 ġimgħat, iżda dehret f'pazjenti wara doża waħda.
English: Zoledronic acid is not metabolised and is excreted unchanged via the kidney.
Maltese: Zoledronic acid ma jiġix immetabolizzat u jiġi eskretat mingħajr ma jinbidel mill-kliewi.
English: Pre-existing hypocalcaemia must be treated by adequate intake of calcium and vitamin D before initiating therapy with Aclasta (see section 4.3).
Maltese: Pazjenti li jkollhom ipokalċimija minn qabel, għandhom ikunu kkurati b'ammonti xierqa ta' kalċju u vitamina D qabel ma tinbeda t-terapija b'Aclasta (ara sezzjoni 4.3).
English: Nausea, vomiting, diarrhoea Uncommon Dyspepsia, abdominal pain upper, abdominal pain, gastro-oesophageal reflux disease, constipation, dry mouth, oesophagitis, toothache, gastritis Skin and subcutaneous tissue disorders Uncommon Rash, hyperhidrosis, pruritus, erythema Musculoskeletal and connective tissue disorders
Maltese: F'pazjenti bil-marda ta' Paget kienu rrappurtati sintomi minħabba li l-kalċju fid-demm ikun baxx, bħal spażmi fil-muskoli, jew tnemnim, jew sensazzjoni ta' tingiż l-aktar mad-dawra tal-ħalq.
English: The long duration of action of zoledronic acid is attributable to its high binding affinity for the active site of farnesyl pyrophosphate (FPP) synthase and its strong binding affinity to bone mineral.
Maltese: Dawn irriżultati żammu milli jkun jista' jiġi ddeterminat effett definittiv ta' Aclasta fuq il-fertilità filbnedmin.
English: In the single-dose dog infusion studies, 1.0 mg/kg (6 fold the recommended human therapeutic exposure based on AUC) administered over 15 minutes was well tolerated with no renal effects.
Maltese: Fi studji b'dożi mogħtija f'darba minn ġol-vina fil-klieb, 1.0 mg/kg (6 darbiet l-esponiment terapewtiku rrakkomandat fil-bniedem ibbażat fuq l-AUC) mogħtija fuq perjodu ta' 15-il minuta kienu ttollerati sew mingħajr effetti renali.
English: LABELLING AND PACKAGE LEAFLET
Maltese: GĦALL-PAKKETT WIEĦED
English: After initiation of the zoledronic acid infusion, plasma concentrations of the active substance increased rapidly, achieving their peak at the end of the infusion period, followed by a rapid decline to < 10% of peak after 4 hours and < 1% of peak after 24 hours, with a subsequent prolonged period of very low concentrations not exceeding 0.1% of peak levels.
Maltese: Wara li tinbeda l-infużjoni b'zoledronic acid, il-konċentrazzjonijiet fil-plażma tas-sustanza attiva jiżdiedu malajr, u jilħqu l-quċċata fl-aħħar tal-perjodu tal-infużjoni, segwit b'waqgħa mgħaġġla għal < 10% tal-quċċata wara 4 sigħat u < 1% tal-quċċata wara 24 siegħa, u wara jkun hemm perjodu twil ta' konċentrazzjonijiet baxxi ħafna li ma jaqbżux iż-0.1% tal-livelli tal-quċċata.
English: For osteoporosis, Aclasta works for one year.
Maltese: Biex tintuża darba biss.
English: As with other bisphosphonates, the retention time of zoledronic acid in bones is very long.
Maltese: Bħal ma jiġri ma' bisfosfonati oħra, iż-żmien ta' ritenzjoni ta' zoledronic acid fl-għadam huwa wieħed twil ħafna.
English: Increasing the infusion time from 5 to 15 minutes caused a 30% decrease in zoledronic acid concentration at the end of the infusion, but had no effect on the area under the plasma concentration versus time curve.
Maltese: Meta l-ħin tal-infużjoni kien imtawwal minn 5 għall-15-il minuta, il-konċentrazzjoni ta' zoledronic acid naqset b'30% fl-aħħar talinfużjoni, iżda ma kellha l-ebda effett fuq il-kurva tal-erja taħt il-konċentrazzjoni tal-plażma kontra lħin.
English: These results were consistent with biochemical marker evidence of normalisation of bone turnover.
Maltese: Dawn irriżultati kienu konsistenti ma' evidenza b'marker bijokimiku ta' tibdil tal-għadam b'rata normali.
English: Treatment of osteoporosis associated with long-term systemic glucocorticoid therapy
Maltese: Disturbi muskoluskeletriċi u tat-tessuti konnettivi
English: In the pooled results, a similar decrease in pain severity and pain interference scores relative to baseline were observed over 6 months for Aclasta and risedronate.
Maltese: Fir-riżultati magħqudin flimkien, tnaqqis simili fis-severità tal-uġigħ u fil-punteġġi ta' interferenza taluġigħ meta mqabbel mal-linja bażi kien osservat fuq 6 xhur għal Aclasta u risedronate.
English: In the trial for the prevention of clinical fractures following a recent hip fracture, vitamin D levels were not routinely measured but the majority of patients received a loading dose of vitamin D prior to Aclasta administration (see section 4.2).
Maltese: Fil-prova għall-prevenzjoni tal-ksur kliniku wara ksur riċenti fil-ġenbejn, il-livelli tal-vitamina D ma ġewx imkejla b'mod regolari iżda l-maġġoranza tal-pazjenti rċevew loading dose ta' vitamina D qabel ma ngħataw Aclasta (ara sezzjoni 4.2).
English: Oral use blister (UPVC/ Monochlorotrifluor ethylene)
Maltese: Folja (UPVC/ Monochlorotrifluorethy lene)
English: Modified-release tablet
Maltese: Pillola li terħi lmediċina b'mod modifikat
English: • paranoia
Maltese: • paranojja
English: Episodes of mania
Maltese: Episodji ta' manija
English: Alopecia, photosensitivity reaction.
Maltese: Alopeċja, reazzjoni ta' fotosensittività.
English: Preferred Term
Maltese: Terminu Ippreferut
English: For further information please see section 2.
Maltese: Għal aktar informazzjoni jekk jogħġbok ara sezzjoni 2.
English: • oral contraceptives
Maltese: • kontraċettivi orali
English: Respiratory depression.
Maltese: Depressjoni respiratorja.
English: Cardiomyopathies, torsades de pointes.
Maltese: Kardjomijopatiji, torsades de pointes.
English: Atrioventricular block, bundle branch block.
Maltese: Imblokk atrijoventrikulari, imblokk tal-bundle branch.
English: MAOIs (non-selective as well as selective A (moclobemide) and B (selegiline)) - risk of “serotonin syndrome” (see section 4.3).
Maltese: MAOIs (mhux selettivi kif ukoll A (moclobemide) u B (selegiline) selettivi) - riskju ta' “sindrome ta' serotonin” (ara sezzjoni 4.3).
English: Polymorphism
Maltese: Polimorfiżmu
English: Contraindicated combinations
Maltese: Kombinazzjonijiet kontraindikati
English: Cardiac symptoms: Arrhythmias (ventricular tachyarrhythmias, torsade de pointes, ventricular fibrillation).
Maltese: Sintomi kardijaċi: Arritmiji (takiarritmiji ventrikulari, torsade de pointes, fibrillazzjoni ventrikulari).
English: Carton/Label
Maltese: Kartuna/Tikketta
English: Continuous ECG-monitoring of cardiac function for 3-5 days.
Maltese: Monitoraġġ kontinwu tal-ECG għall-funzjoni kardijaka għal 3 - 5 ijiem.
English: Further treatment with oral formulation:
Maltese: Aktar trattament bil-formulazzjoni orali:
English: Very common Aggression.
Maltese: Komuni ħafna Aggressjoni.
English: CYP1A2 and CYP2C9.
Maltese: CYP2C9.
English: • disorder of the peripheral nerves
Maltese: • disturb tan-nervituri periferali
English: Acute glaucoma.
Maltese: Glawkoma akuta.
English: MedDRA SOC
Maltese: MedDRA SOC Frekwenza
English: In children under 6 years of age.
Maltese: Fi tfal ta' età inqas minn 6 snin.
English: • Depression in adults (major depressive episodes)
Maltese: • Depressjoni fl-adulti (episodji depressivi maġġuri)
English: In treating depression the duration of treatment is individual, and is usually at least 6 months.
Maltese: Fit-trattament tad-depressjoni t-tul tat-trattament huwa individwali, u normalment huwa mill-inqas 6 xhur.
English: • bipolar disorder
Maltese: • disturb bipolari
English: (tmax = 3.89±1.87 hours; range 1.93-7.98 hours).
Maltese: (tmax = 3.89±1.87 siegħa; firxa 1.93 - 7.98 siegħa).
English: Take this medicine 1-1½ hours before bedtime.
Maltese: Ħu din il-mediċina 1-1½ sigħat qabel tmur torqod.
English: • antidepressants (e.g SSRIs (fluoxetine, paroxetine, fluvoxamine), and bupropion)
Maltese: • antidepressanti (eż. SSRIs (fluoxetine, paroxetine, fluvoxamine), u bupropion)
English: • uncontrolled movements
Maltese: • movimenti mhux ikkontrollati
English: Treatment in respirator is advised to prevent a possible respiratory arrest.
Maltese: Trattament firrespiratur huwa rakkomandat sabiex jiġi evitat waqfien respiratorju possibbli.
English: • phenytoin and carbamazepine (used to treat epilepsy)
Maltese: • phenytoin u carbamazepine (użati għat-trattament tal-epilessija)
English: • sedatives (e.g. babiturates)
Maltese: • sedattivi (eż. babiturates)
English: • rifampicin (to treat infections)
Maltese: • rifampicin (għat-trattament ta' infezzjonijiet)
English: Rare (> 1/10,000, < 1/1,000);
Maltese: Rari (> 1/10,000, < 1/1,000);
English: After oral administration of 50 mg the mean Cmax =21.5±9.0 ng/ml; range 13.2-35.8 ng/ml (77.5±32.4 nmol/L).>
Maltese: Wara għoti orali ta' 50 mg Cmax medja = 21.5±9.0 ng/ml; firxa 13.2-35.8 ng/ml (77.5±32.4 nmol/L).>
English: Common (> 1/100, < 1/10);
Maltese: Komuni (> 1/100, < 1/10);
English: Amitriptyline is a tricyclic antidepressant and an analgesic.
Maltese: Amitriptyline huwa antidepressant triċikliku u analġeżiku.
English: Erectile dysfunction.
Maltese: Disfunzjoni erettili.
English: Potential for amitriptyline to affect other medicinal products Contraindicated combinations
Maltese: Potenzjal ta' amitriptyline li jaffettwa prodotti mediċinali oħra Kombinazzjonijiet kontraindikati
English: The mean absolute oral bioavailability is 53% (Fabs = 0.527±0.123; range 0.219-0.756).>
Maltese: Ilbijodisponibiltà medja assoluta orali hija 53% (Fabs = 0.527±0.123; firxa 0.219-0.756).>
English: • diuretics (“water tablets” e.g. furosemide)
Maltese: • dijuretiċi (“pilloli tal-awrina” eż. furosemide)
English: Antidepressants - Non-selective monoamine reuptake inhibitor (tricyclic antidepressant) ATC code: N 06 AA 09
Maltese: monoamine (antidepressant triċikliku) Kodiċi ATC: N 06 AA 09
English: The mean absolute oral bioavailability is 53% (Fabs = 0.527±0.123; range 0.219-0.756).
Maltese: Il-bijodisponibiltà assoluta orali medja hija 53% (Fabs = 0.527±0.123; firxa 0.219-0.756).
English: • absent sensation of appetite
Maltese: • nuqqas ta' sensazzjoni ta' aptit
English: Bone marrow depression, agranulocytosis, leucopenia, eosinophilia, thrombocytopenia.
Maltese: Depressjoni tal-mudullun, agranuloċitosi, lewkopenija, eosinofilja, tromboċitopenija.
English: Sudden occurrence of CNS depression.
Maltese: Okkorrenza f'daqqa ta' depressjoni tas-CNS.
English: • medicines to treat fungal infections (e.g. fluconazole, terbinafine, ketoconazole, and itraconazole)
Maltese: • mediċini biex jittrattaw infezzjonijiet fungali (eż. fluconazole, terbinafine, ketoconazole, u itraconazole)
English: The metabolism is subject to genetic polymorphism.
Maltese: Il-metaboliżmu huwa suġġett għal polimorfiżmu ġenetiku.
English: • halofantrine (used to treat malaria)
Maltese: • halofantrine (użat għat-trattament tal-malarja)
English: • coma
Maltese: • koma
English: Elderly patients over 65 years of age:
Maltese: Pazjenti anzjani b'età ta' aktar minn 65 sena:
English: • movement disorders (involuntary movements or decreased movements)
Maltese: • disturbi fil-moviment (movimenti involontarji jew movimenti mnaqqsa)
English: Arrhythmia.
Maltese: Arritmija.
English: • astemizole and terfenadine (used to treat allergies and hayfever)
Maltese: • astemizole u terfenadine (użati għat-trattament ta' allerġiji u hayfever)
English: • aged 6 to 10 years: 10 mg - 20 mg daily.
Maltese: • tfal ta' età minn 6 snin sa 10 snin: 10 mg - 20 mg.
English: Examples of strong CYP2D6 inhibitors include bupropion, fluoxetine, paroxetine and quinidine.
Maltese: inibituri qawwija ta' CYP2D6 jinkludu bupropion, fluoxetine, paroxetine u quinidine.
English: Gynaecomastia.
Maltese: Ginekomastija.
English: Concomitant treatment with MAOIs (monoamine oxidase inhibitors) is contra-indicated (see section 4.5).
Maltese: Trattament fl-istess waqt b'MAOIs (inibituri ta' monoamine oxidase) huwa kontraindikat (ara sezzjoni 4.5).
English: • if you are taking medicines known as monoamine oxidase inhibitors (MAOIs)
Maltese: • jekk qed tieħu mediċini magħrufa bħala inibituri ta' monoamine oxidase (MAOIs monoamine oxidase inhibitors)
English: • disturbance in attention
Maltese: • disturb fl-attenzjoni
English: Syncope and torsade de pointes have occurred.
Maltese: Seħħew sinkope u torsade de pointes.
English: • the prophylactic treatment of chronic tension type headache (CTTH) in adults
Maltese: • it-trattament profilattiku ta' uġigħ ta' ras kroniku kkawżat minn tensjoni (CTTH - chronic tension type headache) fl-adulti
English: Levels above 300-400 ng/ml are associated with increased risk of disturbance in cardiac conduction in terms of prolonged QRS-complex or AV block.
Maltese: Livelli ogħla minn 300 - 400 ng/ml huma assoċjati ma' riskju akbar ta' disturbi fil-konduzzjoni kardijaka f'termini ta' kumpless QRS imtawwal jew imblokk AV.
English: X contains lactose
Maltese: X fih lactose
English: The genotoxic potential of amitriptyline has been investigated in various in vitro and in vivo studies.
Maltese: Il-potenzjal ta' effett tossiku fuq il-ġeni ta' amitriptyline ġie investigat f'diversi studji in vitro u in vivo.
English: Prolonged QT interval
Maltese: Intervall ta' QT imtawwal
English: Clinically relevant interactions may be expected with concomitant use of amitriptyline and strong CYP3A4 inhibitors such as ketoconazole, itraconazole and ritonavir.
Maltese: Interazzjonijiet klinikament rilevanti jistgħu jkunu mistennija bl-użu ta' amitriptyline flimkien ma' inibituri qawwija ta' CYP3A4 bħal ketoconazole, itraconazole u ritonavir.
English: metabolic acidosis, hypokalemia.
Maltese: Aċidożi metabolika, ipokalimja.
English: The score line facilitates breaking of the tablet into 4 parts (12.5 mg/part).
Maltese: Is-sinjali mnaqqxa jiffaċilitaw il-qsim tal-pillola f'4 partijiet (12.5 mg/parti).
English: • St. John´s Wort (hypericum perforatum) - a herbal remedy used for depression
Maltese: John's Wort (hypericum perforatum) - mediċina mill-ħxejjex użata għad-depressjoni
English: • children aged 11 years and above: 25 mg - 50 mg daily
Maltese: • età minn 11-il sena 'l fuq: 25 mg - 50 mg
English: The systemic bioavailability is about 50% of the intravenous injection.>
Maltese: Il-bijodisponibiltà sistemika hija madwar 50% tal-injezzjoni ġol-vini.>
English: The pellets in the capsule contain sucrose.
Maltese: Il-pritkuni fil-kapsula fihom sucrose.
English: The daily dosage is in general between 1 and 3 ampoules of 2 ml (equivalent to 50-150 mg amitriptyline hydrochloride/day, equivalent to 44.2 - 132.6 mg amitriptyline/day).
Maltese: u 3 ampulli ta' 2 ml (ekwivalenti għal 50 - 150 mg amitriptyline hydrochloride/jum, ekwivalenti għal 44.2 - 132.6 mg amitriptyline/jum).
English: Amitriptyline and its metabolites are excreted into breast milk (corresponding to 0.6 % - 1 % of the maternal dose).
Maltese: Amitriptyline u l-metaboliti tiegħu huma eliminati fil-ħalib tas-sider (jikkorrispondi għal 0.6 % - 1 % tad-doża tal-omm).
English: However, literature data suggested a risk for malformations and delays in ossification of mice, hamsters, rats and rabbits at 9 33 times the maximum recommended dose.
Maltese: Madankollu, id-dejta fil-letteratura ssuġġeriet riskju ta' malformazzjonijiet u dewmien fl-ossifikazzjoni fil-ġrieden, ħamsters, firien u fniek b'doża 9 33 darba id-doża massima rakkomandata.
English: Antifungals such as fluconazole (CYP2C9 inhibitor) and terbinafine (CYP2D6 inhibitor) have been observed to increase serum levels of amitriptyline and nortriptyline.
Maltese: Antifungali bħal fluconazole (inibitur ta' CYP2C9) u terbinafine (inibitur ta' CYP2D6) ġew osservati li jżidu l-livelli ta' amitriptyline u nortriptyline fis-serum.
English: Initially 25 mg 2 times daily (50 mg daily).
Maltese: Inizjalment 25 mg darbtejn kuljum (50 mg kuljum).
English: Uncommon (> 1/1,000, < 1/100);
Maltese: Mhux komuni (> 1/1,000, < 1/100);
English: Other isozymes involved are CYP1A2 and CYP2C9.
Maltese: Isozimi oħra involuti huma CYP1A2 u CYP2C9.
English: Allergic inflammation of the pulmonary alveoli and of the lung tissue, respectively (alveolitis, Löffler's syndrome).
Maltese: Infjammazzjoni allerġika tal-alveoli tal-pulmun u tat-tessut tal-pulmun, rispettivament (alveolite, sindrome ta' Löffler).
English: The apparent volume of distribution (Vd)β estimated after intravenous administration is 1221 L±280 L; range 769-1702 L (16±3 L/kg).
Maltese: Il-volum apparenti ta' distribuzzjoni (Vd)β stmat wara għoti ġol-vini huwa 1221 L±280 L; firxa 7691702 L (16±3 L/kg).
English: • allergic inflammation of the lung alveoli and of the lung tissue.
Maltese: • infjammazzjoni allerġika tal-alveoli tal-pulmun u tat-tessut tal-pulmun.
English: • Major Depressive Disorder
Maltese: • Disturb Depressiv Maġġuri
English: Jaundice.
Maltese: Deni.
English: Therefore, amitriptyline may increase the risk for cardiac arrhythmia (see section 4.4).
Maltese: amitriptyline jista' jżid ir-riskju ta' arritmija kardijaka (ara sezzjoni 4.4).
English: The main active metabolite is the secondary amine, nortriptyline.
Maltese: Il-metabolit attiv ewlieni huwa l-amine sekondarju, nortriptyline.
English: The apparent volume of distribution (Vd)β estimated after intravenous administration is 1221±280 l; range 769-1702 l (16±3 l/kg).
Maltese: Il-volum apparenti ta' distribuzzjoni (Vd)β stmat wara għoti ġol-vini huwa 1221±280 l; firxa 7691702 l (16±3 l/kg).
English: Lowered consciousness progressing into coma.
Maltese: Koxjenza mnaqqsa bi progressjoni għall-koma.
English: The daily dosage is in general between 1and 3 ampoules of 2 ml (equivalent to 50-150 mg amitriptyline hydrochloride/day).
Maltese: Id-dożaġġ ta' kuljum ġeneralment huwa bejn 1 u 3 ampulli ta' 2 ml (ekwivalenti għal 50 - 150 mg amitriptyline hydrochloride/jum).
English: After peroral administration of 50 mg the mean Cmax = 30.95±9.61 ng/ml; range 10.85-45.70 ng/ml (111.57±34.64 nmol/l; range 39.06-164.52 nmol/l).
Maltese: 85-45.70 ng/ml (111.57±34.64 nmol/l; firxa 39.06-164.52 nmol/l).
English: PHARMACEUTICAL PARTICULARS
Maltese: Kategorija farmakoterapewtika
English: Pregnancy For amitriptyline only limited clinical data are available regarding exposed pregnancies.
Maltese: Għal amitriptyline hemm disponibbli dejta klinika limitata biss dwar tqaliet esposti.
English: Usually the X is added to a solution for infusion.
Maltese: Normalment X jiżdied ma' soluzzjoni għall-infużjoni.
English: Mydriasis.
Maltese: Midrijasi.
English: (24.65±6.31 hours; range 16.49-40.36 hours).
Maltese: (24.65±6.31 siegħa; firxa 16.
English: Not Known Paranoia.
Maltese: Mhux magħrufa Paranojja.
English: Confusional state, libido decreased, agitation.
Maltese: Stat ta' konfużjoni, tnaqqis fil-libido, aġitazzjoni.
English: Very common Palpitations, tachycardia.
Maltese: Komuni ħafna Palpitazzjonijiet, takikardija.
English: The therapeutic plasma concentration in major depression is around 80-200 ng/ml (≈ 280-700 nmol/l) (for amitriptyline + nortriptyline).
Maltese: (≈ 280 - 700 nmol/l) (għal amitriptyline + nortriptyline).
English: The active substance is amitriptyline.
Maltese: Is-sustanza attiva hi amitriptyline.>
English: How to take X
Maltese: X'fih X
English: Saroten and associated names is indicated for in-hospital treatment of major depressive disorders in adults.
Maltese: Saroten u ismijiet assoċjati hu indikat għal trattament fi sptar ta' disturbi depressivi maġġuri fl-adulti.
English: • Migraine prophylaxis in adults
Maltese: • Profilassi tal-emigranja fl-adulti
English: Polymorphism The metabolism is subject to genetic polymorphism (CYP2D6 and CYP2C19) (see section 4.2).
Maltese: Polimorfiżmu Il-metaboliżmu huwa suġġett għal polimorfiżmu ġenetiku (CYP2D6 u CYP2C19) (ara sezzjoni 4.2).
English: Cytochrome P450 inducers: Oral contraceptives, rifampicin, phenytoin, barbiturates, carbamazepine and St. John's Wort (Hypericum perforatum) may increase the metabolism of tricyclic antidepressants and result in lowered plasma levels of tricyclic antidepressants and reduced antidepressant response.
Maltese: Kontraċettivi orali, rifampicin, phenytoin, barbiturates, carbamazepine u St John's Wort (Hypericum perforatum) jistgħu jżidu l-metaboliżmu ta' antidepressanti triċikliċi u jwasslu għal tnaqqis fil-livelli fil-plażma ta' antidepressanti triċikliċi u rispons antidepressiv imnaqqas.
English: Amitriptyline and the main metabolite nortriptyline pass across the placental barrier.
Maltese: Amitriptyline u l-metabolit prinċipali nortriptyline jgħaddu mill-barriera tal-plaċenta.
English: • monoamine oxidase inhibitors (MAOIs) e.g. phenelzine, iproniazid, isocarboxazid, nialamide or tranylcypromine (used to treat depression) or selegiline (used to treat Parkinson's disease).
Maltese: • inibituri ta' monoamine oxidase (MAOIs - monoamine oxidase inhibitors) eż. phenelzine, iproniazid, isocarboxazid, nialamide jew tranylcypromine (użati għat-trattament taddepressjoni) jew selegiline (użat għat-trattament tal-marda ta' Parkinson).
English: NAME OF THE MEDICINAL PRODUCT Saroten and associated names 2 ml, 50 mg solution for injection
Maltese: Saroten u ismijiet assoċjati 2 ml, 50 mg soluzzjoni għall-injezzjoni
English: Combinations requiring precautions for use
Maltese: Kombinazzjonijiet li mhumiex rakkomandati
English: Amitriptyline inhibited ion channels, which are responsible for cardiac repolarization (hERG channels), in the upper micromolar range of therapeutic plasma concentrations.
Maltese: Amitriptyline inibixxa l-kanali tal-joni, li huma responsabbli għal ripolarizzazzjoni kardijaka (kanali hERG), fil-firxa mikromolari ta' fuq ta' konċentrazzjonijiet terapewtiċi fil-plażma.
English: • disturbed coordination
Maltese: • disturb fil-koordinazzjoni
English: The metabolism is subject to genetic polymorphism (CYP2D6 and CYP2C19) (see section 4.2).
Maltese: Il-metaboliżmu huwa suġġett għal polimorfiżmu ġenetiku (CYP2D6 u CYP2C19) (ara sezzjoni 4.2).
English: Other isozymes involved in the metabolism of amitriptyline are CYP3A4, CYP1A2 and CYP2C9.
Maltese: Isozimi oħrajn involuti fil-metaboliżmu ta' amitriptyline huma CYP3A4, CYP1A2 u CYP2C9.
English: • epilepsy, a history of convulsions or fits
Maltese: • epilessija, konvulżjonijiet jew aċċessjonijiet fil-passat
English: Convulsions.
Maltese: Konvulżjoni.
English: The efficacy and safety of amitriptyline has been demonstrated in treatments of the following indications in adults:
Maltese: L-effikaċja u s-sigurtà ta' amitriptyline intwerew fi trattamenti fl-indikazzjonijiet li ġejjin fl-adulti:
English: • cisapride (used to treat certain types of indigestion)
Maltese: • cisapride (użat għat-trattament ta' ċerti tipi ta' indiġestjoni)