FrancophonIA/ELRC3.0 huggingface dataset:
English: The effective daily dose is usually between 15 and 45 mg; the starting dose is 15 or 30 mg. Mirtazapine begins to exert its effect in general after 1-2 weeks of treatment.
Maltese: Id-doża effettiva ta' kuljum hija bejn 15 u 45 mg; id-doża inizzjali hija 15 jew 30 mg.
English: Jaundice Treatment should be discontinued if jaundice occurs.
Maltese: Disturbi ġenerali u kondizzjonijiet ta'mnejn jingħata
English: WHAT REMERON IS AND WHAT IT IS USED FOR Remeron is one of a group of medicines called antidepressants.
Maltese: X'INHU REMERON U GĦALXIEX JINTUŻA Remeron huwa wieħed minn grupp ta' mediċini msejjħa anti-depressanti.
English: Both enantiomers of mirtazapine are presumed to contribute to the antidepressant activity, the S(+) enantiomer by blocking α2 and 5-HT2 receptors and the R(-) enantiomer by blocking 5-HT3 receptors.
Maltese: Huwa preżunt illi ż-żewġ enantjomer ta' mirtazapine jikkontribwixxu għall-attivita` talanti-depressanti, l-enantjomer S (+) billi jimblokka riċetturi α2 u 5-HT2 u l-enantjomer R (-) billi jimblokka riċetturi 5-HT3.
English: 30 (3x10), 60 (6x10), 90 (9x10) and 100 (10x10) film-coated tablets; 14 (2x7), 28 (4x7), 56 (8x7), and 70 (10x7) film-coated tablets.
Maltese: Is-segwenti daqsijiet ta' pakketti huma disponibbli għal pilloli ta' 15 mg fi strixxi: 30 (3x10), 60 (6x10), 90 (9x10) u 100 (10x10) pilloli miksija b'rita; u 14 (2x7), 28 (4x7), 56 (8x7), u 70 (10x7) pilloli miksija b'rita.
English: Lethargy1 Dizziness Tremor
Maltese: ANNESS III SOMMARJU TAL-KARATTERISTIĊI
English: Since the mechanism of interaction is different for MAO-Is with mirtazapine compared to MAO-Is and SSRIs, it is unlikely that the risk of serotonin syndrome is as high as with other serotonergic antidepressants, such as SSRIs.
Maltese: Billi l-mekkaniżmu ta' l-interazzjoni huwa differenti għal MAOIs flimkien ma' mirtazapine meta mqabbel ma' MAO-Is u SSRIs, huwa improbabbli li r-riskju tassindrome ta' serotonin ikun għoli daqs b'antidipressanti serotonerġiċi oħra, bħas-SSRIs.
English: Tablet core: maize starch hyprolose magnesium stearate silica, colloidal anhydrous lactose monohydrate
Maltese: Il-qalba tal-pillola: maize starch hyprolose magnesium stearate silica, colloidal anhydrous lactose monohydrate Kisja tal-pillola: hypromellose Macrogol 8000 titanium dioxide (E171) yellow iron oxide (E172)
English: 10 film-coated tablets 20 film-coated tablets 30 film-coated tablets 50 film-coated tablets 100 film-coated tablets 200 film-coated tablets 500 film-coated tablets
Maltese: 10 pilloli miksija b'rita 20 pillola miksija b'rita 30 pillola miksija b'rita 50 pillola miksija b'rita 100 pillola miksija b'rita 200 pillola miksija b'rita 500 pillola miksija b'rita
English: Myoclonus
Maltese: Ċipru
English: Usually you will need to take Remeron until your symptoms of depression have disappeared for 4 to 6 months.
Maltese: Issoltu għandek tkompli tieħu Remeron sakemm jisparixxu s-sintomi tad-dipressjoni għal bejn 4 u 6 xhur.
English: - In addition, as with SSRIs, co-administration with other serotonergic active substances (Ltryptophan, triptans, tramadol, linezolid, SSRIs, venlafaxine, lithium and St. John's Wort - Hypericum perforatum - preparations) may lead to an incidence of serotonin associated effects (serotonin syndrome: see section 4.4) Caution should be advised and a closer clinical monitoring is required when these drugs are combined with mirtazapine.
Maltese: John's Wort - Hypericum perforatum - preparazzjonijiet) jista' jwassal għal inċidenza ta' effetti assoċjati ma' serotonin (sindromu tas-serotonin: ara sezzjoni 4.4) Għandha tiġi rakkomandata kawtela u huwa meħtieġ monitoraġġ kliniku iżjed mill-qrib meta dawn il-mediċini jingħataw flimkien ma' mirtazapine.
English: Table 1 shows the categorized incidence of the adverse reactions, which occurred in the clinical trials statistically significantly more frequently during treatment with Remeron than with placebo, added with adverse reactions from spontaneous reporting.
Maltese: Tabella 1 turi l-inċidenza kategorizzata tal-effetti mhux mixtieqa li seħħew fi provi kliniċi b'mod statistikament sinjifikanti iktar frekwenti waqt it-trattament b'Remeron milli bi plaċebo, miżjuda ma' effetti mhux mixtieqa rrapurtati spontanjament.
English: LIST OF EXCIPIENTS Lactose monohydrate See leaflet for further information.
Maltese: LISTA TA' SUSTANZI MHUX ATTIVI Lactose monohydrate Ara l-fuljett għal iktar informazzjoni.
English: Remeron 15, 30 and 45 mg film-coated tablets are also available in HDPE bottles with a tamperevident LDPE cap.
Maltese: Il-pilloli miksija b'rita Remeron 15, 30 u 45 mg huma disponibbli wkoll fi fliexken HDPE b'tapp LDPE li jurik jekk jiġi mbagħbas.
English: - hepatic impairment: Following a single 15 mg oral dose of mirtazapine, the clearance of mirtazapine was approximately 35 % decreased in mild to moderate hepatically impaired patients, compared to subjects with normal hepatic function.
Maltese: Wara doża orali waħda ta' 15 mg ta' mirtazapine, it-tneħħija ta' mirtazapine kien imnaqqas b'madwar 35 % f'pazjenti bi ftit indeboliment epatiku għal moderata pparagunati ma' suġġetti b'funzjoni epatika normali.
English: This should be taken into account when prescribing Remeron to this category of patients (see section 4.4).
Maltese: Dan għandu jingħata kunsiderazzjoni meta Remeron jiġi miktub lil pazjenti ta' din il-kategorija (ara sezzjoni 4.4).
English: Sucrose
Maltese: Greċja
English: SPC Section 4.2 Posology and Method of Administration
Maltese: SPC Sezzjoni 4.2 Pożoloġija u Metodu ta' kif għandu jingħata
English: In Section 4.2 Posology and method of administration of the SPC, the CHMP considered that the sentence “Treatment should preferably be continued until the patient has been completely symptomfree for 4-6 months” should be replaced by “Patients with depression should be treated for a sufficient period of at least 6 months to ensure that they are free from symptoms.” (in accordance with the wording of other antidepressants).
Maltese: Fis-Sezzjoni 4.2 ta' l-SPC, Pożoloġija u metodu ta' kif għandu jingħata, is-CHMP ħass li s-sentenza “It-trattament għandu preferibbilment jitkompla sakemm il-pazjent ikun ħeles mis-sintomi għal 4-6 xhur” għandha tiġi sostitwita bi “Il-pazjenti b'depressjoni għandhom jiġu kkurati għal perjodu suffiċjenti ta' mill-anqas 6 xhur biex ikun żgurat li ħelsu mis-sintomi.” (skond il-kliem ta' antidipressanti oħra).
English: Additionally in Section 4.5 of the SPC, the CHMP considered it sufficient to state that Lithium and mirtazapine showed no pharmacokinetic interactions (last paragraph section 4.5) without further specifications.
Maltese: Barra minn hekk f'Sezzjoni 4.5 tal-SPC, is-CHMP ħass li kien suffiċjenti li jiddikjara li l-Lithium u mirtazapine ma wrew l-ebda interazzjonijiet farmakokinetiċi (l-aħħar paragrafu ta' sezzjoni 4.5) mingħajr iżjed speċifikazzjonijiet.
English: The CHMP considered that the arguments provided by the applicant/MAH were insufficient to justify that mirtazapine would act different from SSRIs and SNRIs (e.g. venlafaxine).
Maltese: Is-CHMP ħass li l-argumenti pprovduti mill-applikant/Detentur ta' lApplikazzjoni għat-Tqegħid fis-Suq ma kinux suffiċjenti biex jiġġustifikaw li mirtazapine ser jaġixxi b'mod differenti mis-SSRIs u s-SNRIs (eż, venlafaxine).
English: The carton contains one brown (type III) glass bottle containing 66 ml of Remeron oral solution and one metering pump.
Maltese: Il-kartuna fiha flixkun wieħed kannella (tip III) tal-ħġieġ b'66 ml ta' soluzzjoni orali Remeron u pompa waħda tad-dożaġġ.
English: Elderly
Maltese: Awstrija
English: • inappropriate anti-diuretic hormone secretion
Maltese: • Sekrezzjoni mhux xierqa ta' l-ormon antidijuretiku
English: 14 film-coated tablets 28 film-coated tablets 56 film-coated tablets 70 film-coated tablets
Maltese: 14-il pillola miksija b'rita 28 pillola miksija b'rita 56 pillola miksija b'rita 70 pillola miksija b'rita
English: Box
Maltese: Svezja
English: Mirtazapine Remeron SolTab 45 mg Orodispersible tablets Oral use Mirtazapine Remeron Soltab 15 mg Orodispersible tablets Oral use Mirtazapine Remeron Soltab 30 mg Orodispersible tablets Oral use Mirtazapine Remeron Soltab 45 mg Orodispersible tablets Oral use Mirtazapine Remeron
Maltese: Remeron u ismijiet assoċjati miegħu (Ara Anness I) pilloli miksija b'rita 15 mg Remeron u ismijiet assoċjati miegħu (Ara Anness I) pilloli miksija b'rita 30 mg Remeron u ismijiet assoċjati miegħu (Ara Anness I) pilloli miksija b'rita 45 mg [Ara Anness I - Biex timtela mill-pajjiż partikolari]
English: Studies in animals have not shown any teratogenic effects of clinical relevance, however developmental toxicity has been observed (see section 5.3).
Maltese: Studji fuq il-bhejjem ma jurux effetti teratonerġiċi ta' rilevanza klinika, iżda ġiet osservata ħsara fuq l-iżvilupp (ara sezzjoni 5.3).
English: Fatal cases mostly concerned patients with an age above 65.
Maltese: Każijiet fatali kkonċernaw l-aktar pazjenti ta' eta` ‘l fuq minn 65.
English: Limited experience with Remeron administration to pregnant women does not indicate an increased risk.
Maltese: Esperjanza limitata bl-għoti ta' Remeron lil nisa tqal ma tindikax żieda fir-riskju.
English: 4 N.B. dose reduction generally does not lead to less somnolence/sedation but can jeopardize antidepressant efficacy.
Maltese: 4N.B. Riduzzjoni fid-doża ġeneralment ma twassalx għal sonnolenza/sedazzjoni imma jista' jippreġudika l-effikaċja antidipressanti
English: MAO-inhibitors are therefore relatively contra-indicated with Remeron.
Maltese: L-inibituri MAO għalhekk huma relattivament kontra-indikati ma' Remeron.
English: No significant differences were found in patients with mild renal impairment (creatinine clearance <80 ml/min) as compared to the control group.
Maltese: Ma nstabux differenzi sinjifikanti f'pazjenti b'indeboliment renali ħafif (tneħħija ta' cretainine <80 ml/min) meta pparagunati mal-grupp talkontroll.
English: Remeron 30 mg film-coated tablets are oval, biconvex, red-brown, scored and coded with ‘Organon' on one side and with ‘TZ/5' on the other side.
Maltese: Il-pilloli miksija b'rita Remeron 30 mg huma ovali, konvessi miż-żewġ naħat, ta' kulur kannella ħamrani, immarkati tul in-nofs u mmarkati ‘Organon' fuq naħa waħda u kodiċi ‘TZ/5'fuq in-naħa loħra.
English: The metering pump is packed in a sealed plastic bag.
Maltese: Qabbadha mal-flixkun u daħħal it-tubu tal-plastik ġolflixkun.
English: Patients with a history of suicide-related events or those exhibiting a significant degree of suicidal ideation prior to commencement of treatment are known to be at greater risk of suicidal thoughts or suicide attempts, and should receive careful monitoring during treatment.
Maltese: Pazjenti b'passat ta' eventi relatati mas-suwiċidju jew dawk li juru grad sinjifikattiv ta' ideat suwiċidali qabel ma jinbeda t-trattament huma magħrufa li jkunu f'riskju ikbar ta' ħsibijiet suwiċidali jew attentati suwiċidali, u għandhom jiġu mmonitorjati bir-reqqa waqt it-trattament.
English: In addition, as with SSRIs, co-administration with other serotonergic active substances (Ltryptophan, triptans, tramadol, linezolid, SSRIs, venlafaxine, lithium and St. John's WortHypericum perforatum - preparations) may lead to an incidence of serotonin associated effects (serotonin syndrome: see section 4.4).
Maltese: Barra minn hekk, bħal b'SSRIs, ko-amministrazzjoni ma' sustanzi attivi serotonerġiċi oħrajn (L-tryptophan, triptans, tramadol, linezolid, SSRIs, venlafaxine, litju u St.
English: Mirtazapine Zispin® oral solution15 mg/ml
Maltese: Remeron u ismijiet assoċjati miegħu (Ara Anness I) soluzzjoni orali 15 mg/ml
English: Each Remeron 30 mg orodispersible tablet contains 30 mg of mirtazapine.
Maltese: Kull pillola miksija b'rita Remeron 30 mg fiha 30 mg ta' mirtazapine.
English: Caution should be exercised when co-administering mirtazapine with potent CYP3A4 inhibitors, HIV protease inhibitors, azole antifungals, erythromycin or nefazodone.
Maltese: Għandha tintuża kawtela meta wieħed jagħti mirtazapine fl-istess ħin ma' inibituri qawwija ta' CYP3Ar, inibituri tal-protease tal-HIV, antifungali azole, erythromycin jew nefazodone.
English: In addition, as with other SSRIs, co-administration with other serotonergic drugs active substances (L-tryptophan, triptans, tramadol, linezolid, SSRIs, venlafaxine, lithium and St. John's WortHypericum perforatum - preparations) may lead to an incidence of serotonin 5-HT associated effects (serotonin syndrome: see Section 4.3 Contraindications and section 4.4 Special Warnings and Special Precautions for Use).
Maltese: John's WortHypericum perforatum - preparazzjonijiet) jista' jwassal għal inċidenza ta' effetti assoċjati ma' serotonin 5-HT (sindromu tas-serotonin: ara Sezzjoni 4.3 Kontra-indikazzjonijiet u sezzjoni 4.4
English: When carbamazepine or any other inducer of hepatic metabolism (such as rifampicin) is added to mirtazapine therapy, the mirtazapine dose may have to be increased.
Maltese: Meta carbamazepine jew induttur ieħor ta' metaboliżmu epatiku (bħal rifampicin) huwa miżjud ma' terapija b'mirtazapine, jista' jkun hemm bżonn ta' żieda fid-doża ta' mirtazapine.
English: In addition, the most recent EU Guideline was only established in 1994 (Note for Guidance on the evaluation on the pharmacokinetics of medicinal products in patients with impaired renal function, CHMP/EWP/225/02).
Maltese: Barra minn hekk, l-iżjed Linja gwida riċenti ta' l-UE kienet stabbilita biss fl1994 (Nota għall-Gwida dwar l-evalwazzjoni dwar il-farmakokinetiċi tal-prodotti mediċinali f'pazjenti b'indeboliment fil-funzjoni tal-kliewi, CHMP/EWP/225/02).
English: Diarrhea2 Vomiting2
Maltese: ANNESS II KONKLUŻJONIJIET XJENTIFIĊI
English: Mirtazapine Mirtazapin STADA 15 mg Orodispersible tablets Oral use Mirtazapine Mirtazapin STADA 30 mg Orodispersible tablets Oral use
Maltese: Użu orali MirtazapineRemeron drank 15 mg/ml Soluzzjoni orali Użu orali
English: • sensations of numbness in the mouth (oral hypoaesthesia)
Maltese: • sensazzjoni ta' tirżiħ fil-ħalq (ipoesteżija orali)
English: • a combination of symptoms such as inexplicable fever, sweating, increased heart rate, diarrhoea, (uncontrollable) muscle contractions, shivering, overactive reflexes, restlessness, mood changes and unconsciousness.
Maltese: • taħlita ta' sintomi bħal deni inspjegabbli, għaraq, żieda fir-rata tal-qalb, dijarrea, kontrazzjonijiet tal-muskoli (inkontrollabbli), tregħid, riflessi attivi żżejjed, aġitazzjoni, bdil tal-burdata u tintilef minn sensik.
English: 45 mg Orodispersible tablets Oral use Mirtazapine REMERON 15 mg 15 mg Film-coated tablets
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Pillola waħda miksija b'rita fiha 15 mg mirtazapine
English: Remeron 15
Maltese: NO6AX11
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 film-coated tablet contains 45 mg mirtazapine
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kull pillola li tinħall fil-ħalq fiha 45 mg mirtazapine
English: Schmelztabletten
Maltese: TAL-PRODOTT MEDIĊINALI
English: 15 mg Oral Solution
Maltese: 15 mg/ml Soluzzjoni orali Użu orali
English: BATCH NUMBER BN
Maltese: Renju Unit
English: - Mirtazapine dosed at 30 mg once daily caused a small but statistically significant increase in the international normalized ratio (INR) in subjects treated with warfarin.
Maltese: - Mirtazapine f'doża ta' 30mg darba kuljum ikkawżat żieda żgħira imma statistikament sinjifikanti fir-razzjon normalizzat internazzjonali (INR) f'suġġetti ttrattati b'warfarin.
English: Mirtazapine Remeron Sol Tab 15 mg Orodispersible tablets Oral use Mirtazapine Remeron Sol Tab 30 mg Orodispersible tablets Oral use
Maltese: Remeron u ismijiet assoċjati miegħu (Ara Anness I) pilloli miksija b'rita 30 mg [Ara Anness I - Biex timtela mill-pajjiż partikolari]
English: Each Remeron 45 mg orodispersible tablet contains 45 mg of mirtazapine.
Maltese: Kull pillola miksija b'rita Remeron 45 mg fiha 45 mg ta' mirtazapine.
English: Moreover, the CHMP was of the opinion that the mechanism of interaction with MAOIs with mirtazapine is different from SSRIs.
Maltese: Barra minn hekk, is-CHMP kien ta' lopinjoni li l-mekkaniżmu ta' l-interazzjoni tal-MAOIs ma' mirtazapine hu differenti mis-SSRIs.
English: Inappropriate antidiuretic hormone secretion 1 In clinical trials these events occurred statistically significantly more frequently during treatment with Remeron than with placebo.
Maltese: 1Fi provi kliniċi dawn l-eventi seħħew bi frekwenza iktar sinjifikanti statistikament waqt trattament b'Remeron milli bi plaċebo
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 film-coated tablet contains 30 mg mirtazapine
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kull pillola li tinħall fil-ħalq fiha 30 mg mirtazapine
English: Mirtazapine REMERON 45 MG 45 mg Film-coated tablets
Maltese: MirtazapineREMERON 45 mg 45 mg Pilloli miksija b'rita
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 film-coated tablet contains 15 mg mirtazapine
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kull pillola li tinħall fil-ħalq fiha 15 mg mirtazapine
English: 3 In clinical trials these events occurred statistically significantly more frequently during treatment with placebo than with Remeron.
Maltese: 3Fi provi kliniċi dawn l-eventi seħħew bi frekwenza iktar sinjifikanti statistikament waqt trattament bi plaċebo milli b'Remeron
English: Remeron.
Maltese: Fig.
English: • if you have severe hay fever.
Maltese: • jekk għandek hay fever severa.
English: Nervousness Not known Depression
Maltese: Nervi Mhux magħruf Depressjoni
English: • myasthenia gravis (chronic neuromuscular weakness).
Maltese: • mijastenija gravis (debbulizza newromuskolari kronika).
English: Additionally:
Maltese: NN:
English: Clinical effects
Maltese: Effetti Kliniċi
English: They are ranked according to system organ class and classified according to the following convention: 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), or not known (cannot be estimated from the available data).
Maltese: Huma mqassma skont is-sistema tal-klassifika tal-organi u klassifikati skont ilkonvenzjoni li ġejja: komuni ħafna(≥1/10), komuni (>1/100 sa <1/10), mhux komuni (>1/1,000 sa ≤1/100), rari (>1/10,000 sa ≤1/1,000), rari ħafna (≤1/10,000), jew mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: Each mL of solution contains polyquaternium-1 (POLYQUAD) 10 microgram, propylene glycol 5 mg and polyoxyethylene hydrogenated castor oil 40 1 mg (see section 4.4).
Maltese: Kull mL ta' soluzzjoni fih 10 mikrogrammi polyquaternium-1 (POLYQUAD), 5 mg propylene glycol u 1 mg polyoxyethylene hydrogenated castor oil 40 (ara sezzjoni 4.4).
English: Packs of 1, 3 or 6 bottles.
Maltese: Pakketti ta' 1, 3 jew 6 fliexken.
English: • Make sure you have a mirror available.
Maltese: • Kun żgur li għandek mera disponibbli.
English: Alanine aminotransferase increased, aspartate aminotransferase increased
Maltese: Żjieda fl-alanine aminotransferase, żjieda flaspartate aminotransferase
English: Sexual dysfunction, decreased libido
Maltese: Disfunzjoni sesswali, libido mnaqqas
English: Contains: Polyquaternium-1, mannitol (E421), propylene glycol (E1520), polyoxyethylene hydrogenated castor oil 40 (HCO-40), boric acid, sodium chloride, sodium hydroxide and/or hydrochloric acid (to adjust pH), purified water.
Maltese: Fih: Polyquaternium-1, mannitol (E421), propylene glycol (E1520), polyoxyethylene hydrogenated castor oil 40 (HCO-40), boric acid, sodium chloride, sodium hydroxide u/jew hydrochloric acid (biex jikontrolaw il-pH), ilma ppurifikat.
English: Reproduction: sexual dysfunction, decreased libido.
Maltese: Riproduzzjoni: disfunzjoni sesswali, libido mnaqqas.
English: Insomnia, nightmares, memory loss
Maltese: Insomnja, inkubi, telf ta' memorja
English: • cataract surgery.
Maltese: • kirurġija tal-katarretti.
English: Beta-blocking ophthalmological preparations may block systemic beta-agonist effects, e.g. of adrenaline.
Maltese: Preparazzjonijiet imblokkaturi tar-riċetturi beta għall-għajnejn jistgħu jimblokkaw effetti beta-agonisti sistemiċi, eż. tal-adrenalina.
English: Sodium hydroxide and/ or hydrochloric acid (for pH adjustment) Purified water
Maltese: Sodium hydroxide u/jew hydrochloric acid (għall-aġġustament tal-pH) Ilma ppurifikat
English: Metabolism: low blood sugar levels, increase in prostate cancer marker.
Maltese: Metaboliżmu: livelli baxxi ta' zokkor fid-demm, żieda fil-markatur tal-kanċer tal-prostata.
English: In a three-month controlled clinical study in patients with open-angle glaucoma or ocular hypertension and baseline mean IOP of 27 to 30 mmHg, the mean IOP-lowering effect of DuoTrav dosed once daily in the morning was 9 to 12 mmHg, and was up to 2 mmHg greater than that of travoprost 40 micrograms/mL dosed once daily in the evening and 2 to 3 mmHg greater than that of timolol 5 mg/mL dosed twice daily.
Maltese: Fi studju kliniku kkontrollat ta' tliet xhur, f'pazjenti bi glawkoma open angle jew pressjoni għolja ta' l-għajnejn u linja bażi medja ta' IOP ta' 27 sa 30 mmHg, l-effett medju ta' tnaqqis fl-IOP ta' DuoTrav mogħti darba kuljum filgħodu kien ta' 9 sa 12 mmHg, u kien sa 2 mmHg aktar minn dak ta' travoprost 40 mikrogramma/mL mogħti darba kuljum filgħaxija u 2 sa 3 mmHg aktar minn dak ta' timolol 5 mg/mL mogħti darbtejn kuljum.
English: DuoTrav contains two active substances: travoprost and timolol maleate.
Maltese: DuoTrav fih żewġ sustanzi attivi: travoprost u timolol maleate.
English: There is a potential for additive effects resulting in hypotension and/or marked bradycardia when ophthalmic beta-blocker solution is administered concomitantly with oral calcium channel blockers, beta-adrenergic blocking agents, antiarrhythmics (including amiodarone), digitalis glycosides, parasympathomimetics or guanethidine.
Maltese: Hemm il-potenzjal li effetti addittivi jirriżultaw fi pressjoni baxxa u/jew bradikardja qawwija meta soluzzjoni ta' imblokkatur tar-riċetturi beta għall-għajnejn tingħata flimkien ma' imblokkaturi talkanali tal-kalċju, sustanzi mblokkaturi beta-adrenerġiċi, antiarritmijaċi (inkluż amiodarone), digitalis glycosides, parasimpatomimetiċi jew guanethidine.
English: Beta-adrenergic blocking medicinal products have been reported to potentiate muscle weakness consistent with certain myasthenic symptoms (e.g. diplopia, ptosis and generalised weakness).
Maltese: Prodotti mediċinali mblokkaturi tar-riċetturi beta-adrenerġiċi kienu rrappurtati li jżidu d-dgħufija filmuskoli konsistenti ma' ċerti sintomi mijasteniċi (eż. diplopja, ptosi u dgħufija ġeneralizzata).
English: - The other ingredients are Polyquaternium-1, mannitol (E421), propylene glycol (E1520), polyoxyethylene hydrogenated castor oil 40, boric acid, sodium chloride, sodium hydroxide or hydrochloric acid (to adjust pH), purified water.
Maltese: - Is-sustanzi l-oħra huma Polyquaternium-1, mannitol (E421), propylene glycol (E1520), polyoxyethylene hydrogenated castor oil 40, boric acid, sodium chloride, sodium hydroxide jew disodium edetate, hydrochloric acid (biex jikontrolla l-pH), ilma ppurifikat.
English: In a 6-week controlled clinical study in patients with open-angle glaucoma or ocular hypertension and baseline mean IOP of 24 to 26 mmHg, the mean IOP-lowering effect of DuoTrav (polyquaternium-1-preserved) dosed once daily in the morning was 8 mmHg and equivalent to that of DuoTrav (benzalkonium chloride-preserved).
Maltese: Fi studju kliniku kkontrollat ta' 6 ġimgħat f'pazjenti bi glawkoma open-angle jew pressjoni għolja talgħajnejn u IOP medja fil-linja bażi ta' 24 sa 26 mmHg, l-effett medju ta' tnaqqis fl-IOP ta' DuoTrav (ippreservat b'polyquaternium-1) mogħti darba kuljum filgħodu kien ta' 8 mmHg u ekwivalenti għal dak ta' DuoTrav (ippreservat b'benzalkonium chloride).
English: • overactivity of the thyroid gland (as timolol may mask signs and symptoms of thyroid disease).
Maltese: • attività żejda tal-glandola tat-tirojde (peress li timolol jista' jgħatti sinjali u sintomi ta' marda tat-tirojde).