FrancophonIA/ELRC3.0 huggingface dataset:
English: • imatinib, lapatinib (used to treat cancer)
Maltese: • sumatriptan, zolmitriptan (użati għat-trattament tal-emigranja) • imatinib, lapatinib (jintużaw għat-trattament tal-kanċer)
English: The no observed adverse effect levels (NOAELs) for foetal toxicity in mice (5 mg/kg/day) as well as maternal and foetal toxicity in rats (2.5 mg/kg/day) were associated with tedizolid plasma area under the curve (AUC) values approximately equivalent to the tedizolid AUC value associated with the oral human therapeutic dose.
Maltese: (5 mg/kg/jum) kif ukoll tossiċità tal-omm u tal-fetu fil-firien (2.5 mg/kg/jum) kienu assoċjati ma' valuri tal-erja taħt il-kurva (AUC) tal-plażma ta' tedizolid bejn wieħed u ieħor ekwivalenti għall-valur tal-AUC ta' tedizolid assoċjat mad-doża orali terapewtika tal-bniedem.
English: Sivextro must be reconstituted with water for injections and subsequently diluted in 250 mL of 0.9% sodium chloride for infusion.
Maltese: Sivextro għandu jiġi rikostitwit bl-ilma għall-injezzjonijiet u sussegwentement għandu jiġi dilwit b'250 mL ta' 0.9% ta' sodium chloride għall-infużjoni.
English: Uncommon reactions (phlebitis)
Maltese: Disturbi fil-qalb
English: The mean steady state volume of distribution of tedizolid in healthy adults (n=8) following a single intravenous dose of tedizolid phosphate 200 mg ranged from 67 to 80 L.
Maltese: Il-medja tal-volum ta'distribuzzjoni ta' tedizolid fl-istat fiss f'adulti f'saħħithom (n=8) wara doża ġol vina waħda ta' tedizolid phosphate 200 mg varja minn 67 sa 80 L.
English: Oral and intravenous tedizolid phosphate is a prodrug that is rapidly converted by phosphatases to tedizolid, the microbiologically active moiety.
Maltese: Tedizolid phosphate orali jew ġol-vina huwa promediċina li tiġi kkonvertita malajr permezz ta' phosphatases għal tedizolid, il-parti mikrobijoloġikament attiva.
English: Antibacterial activity in combination with other antibacterial and antifungal agents
Maltese: Attività antibatterika flimkien ma' sustanzi antibatteriċi u antifungali oħrajn
English: The impact of gender on the pharmacokinetics of tedizolid phosphate was evaluated in healthy males and females in clinical studies and in a population pharmacokinetics analysis.
Maltese: L-impatt tal-ġeneru sesswali fuq il-farmakokinetika ta' tedizolid phosphate kien evalwat f'irġiel u f'nisa f'saħħithom fi studji kliniċi u f'analiżi tal-farmakokinetika tal-popolazzjoni.
English: Efficacy has been demonstrated in clinical studies against the pathogens listed under each indication that were susceptible to tedizolid in vitro.
Maltese: Intweriet effikaċja fi studji kliniċi kontra l-patoġeni elenkati taħt kull indikazzjoni li kienu suxxettibbli għal tedizolid in vitro.
English: Merck Sharp & Dohme Cyprus Limited Τηλ: 800 00 673 (+357 22866700) cyprus_info@merck.com
Maltese: Τηλ: 800 00 673 (+357 22866700)
English: Do not take Sivextro
Maltese: Tiħux Sivextro
English: Abdominal pain upper Flatulence
Maltese: Qalba tal-pillola
English: A clinical study comparing the single dose (2 mg) pharmacokinetics of midazolam (CYP3A4 substrate) alone or in combination with tedizolid phosphate (once-daily 200 mg oral dose for 10 days), demonstrated no clinically meaningful difference in midazolam Cmax or AUC.
Maltese: (2 mg) ta' midazolam (sustrat ta' CYP3A4) waħdu jew flimkien ma' tedizolid phosphate (doża ta' 200 mg darba kuljum mill-ħalq għal 10 ijiem),
English: The mean Cmax and AUC0-∞ for oral or IV administration of tedizolid phosphate 200 mg were similar in adolescent and in healthy adult subjects.
Maltese: Il-medja tas-Cmax u l-AUC0-∞ għall-għoti orali jew ġol-vina ta' tedizolid phosphate 200 mg kienu simili f'adolexxenti u f'individwi adulti f'saħħithom.
English: Two placebo-controlled crossover studies were conducted to assess the potential of 200 mg oral tedizolid phosphate at steady state to enhance pressor responses to pseudoephedrine and tyramine in healthy individuals.
Maltese: Twettqu żewġ studji crossover ikkontrollati bi plaċebo biex jiġi vvalutat il-potenzjal ta' 200 mg tedizolid phosphate orali fi stat fiss li jsaħħaħ ir-risponsi ta' żieda fil-pressjoni permezz ta' tagħfis talkanali tad-demm ta' pseudoephedrine u tyramine f'individwi f'saħħithom.
English: Other than tedizolid, which accounts for approximately 95% of the total radiocarbon AUC in plasma, there are no other significant circulating metabolites.
Maltese: Minbarra tedizolid, li jammonta għal madwar 95% tal-AUC talkarbonju radjuattiv totali fil-plażma, m'hemm ebda metabolit sinifikanti ieħor li jiċċirkola.
English: Tel: +353 (0)1 299 8700 medinfo_ireland@merck.com
Maltese: Tel: +353 (0)1 299 8700
English: If a rapid antibiotic effect is needed, the intravenous administration should be considered.
Maltese: Jekk ikun hemm bżonn ta' effett antibijotiku rapidu, għandu jiġi kkunsidrat għoti ġol-vina.
English: Hepatic impairment No dosage adjustment is required (see section 5.2).
Maltese: Indeboliment epatiku Ma huwa meħtieġ l-ebda aġġustament għad-doża (ara sezzjoni 5.2).
English: After reconstitution each mL contains 50 mg tedizolid phosphate.
Maltese: Wara r-rikostituzzjoni, kull ml fih 50 mg tedizolid phosphate.
English: Currently available data are described in section 5.2, but no recommendation on a posology can be made.
Maltese: Data disponibbli attwalment hija deskritta fis-sezzjoni 5.2, iżda ma tista' ssir l-ebda rakkomandazzjoni dwar pożoloġija.
English: Diabetes mellitus inadequate control
Maltese: Kontroll inadegwat ta' dijabete mellitus
English: Talc
Maltese: Macrogol Talc
English: There is limited experience with tedizolid phosphate in the treatment of patients with concomitant acute bacterial skin and skin structure infections and secondary bacteremia and no experience in the treatment of ABSSSI with severe sepsis or septic shock.
Maltese: Hemm esperjenza limitata b'tedizolid phosphate fit-trattament ta' pazjenti b'infezzjonijiet batterjali akuti tal-ġilda u tal-istruttura tal-ġilda konkomittanti u b'batterimja sekondarja u ebda esperjenza fittrattament ta' ABSSSI b'sepsi gravi jew xokk settiku.
English: Patients who commence treatment on the parenteral formulation may be switched to the oral presentation when clinically indicated.
Maltese: Il-pazjenti li jibdew trattament bil-formulazzjoni parenterali jistgħu jinqalbu għall-preżentazzjoni orali meta indikat klinikament.
English: Sivextro contains sodium
Maltese: Kif jidher Sivextro u l-kontenut tal-pakkett
English: Peripheral neuropathy, as well as optic neuropathy sometimes progressing to loss of vision, have been reported in patients treated with another member of the oxazolidinone class with treatment durations exceeding that recommended for tedizolid phosphate.
Maltese: Newropatija periferali, kif ukoll newropatija ottika li xi drabi jwasslu għal telf tal-vista, ġew irrapportati f'pazjenti ttrattati b'membru ieħor tal-klassi ta' oxazolidinone b'tul ta' trattament li jaqbeż dak rakkomandat għal tedizolid phosphate.
English: Tedizolid is excreted in the breast milk of rats (see section 5.3).
Maltese: Ma huwa meħtieġ l-ebda aġġustament għad-doża (ara sezzjoni 5.2).
English: In ABSSSI, the types of infections treated were confined to cellulitis/erysipelas or major cutaneous abscesses, and wound infections only.
Maltese: F'ABSSSI, it-tipi ta' infezzjonijiet ittrattati kienu ristretti għal ċellulite/irsipli jew axxessi kutanji maġġuri, u infezzjonijiet fil-feriti biss.
English: • Fungal infections of skin , mouth and vagina (oral / vaginal thrush)
Maltese: • Infezzjonijiet fungali tal-ġilda, il-ħalq u l-vaġina (traxx orali/vaġinali)
English: For storage conditions after reconstitution and dilution of the medicinal product, see section 6.3.
Maltese: Għall-kondizzjonijiet ta' ħażna wara r rikostituzzjoni u d-dilwizzjoni tal-prodott mediċinali, ara sezzjoni 6.3.
English: • Itching (including itching due to allergic reaction), hair loss, acne, red and/or itchy rash or hives,
Maltese: • Ħakk (inkluż ħakk minħabba reazzjoni allerġika), telf ta' xagħar, akne, raxx jew ħorriqija ħamra u/jew bil-ħakk, jew tegħreq b'mod eċċessiv
English: In a clinical study comparing the single dose (10 mg) pharmacokinetics of rosuvastatin (BCRP substrate) alone or in combination with the oral administration of tedizolid phosphate 200 mg, rosuvastatin AUC and Cmax increased by approximately 70% and 55%, respectively, when coadministered with Sivextro.
Maltese: BCRP) waħdu jew flimkien ma' għoti mill-ħalq ta' tedizolid phosphate 200 mg, l-AUC u s-Cmax ta' rosuvastatin, żdiedu b'madwar 70% u 55%, rispettivament, meta ngħata flimkien ma' Sivextro (ara sezzjoni 4.5).
English: Neuropathy (optic and peripheral) has not been reported in patients treated with tedizolid phosphate at the recommended treatment duration of 6 days.
Maltese: Newropatija (ottika u periferali) ma ġietx irrapportata f'pazjenti ttrattati b'tedizolid phosphate għat-tul ta' żmien ta' trattament rakkomandat ta' 6 ijiem.
English: The safety and efficacy of tedizolid phosphate in children and adolescents below 18 years of age have not yet been established.
Maltese: Is-sigurtà u l-effikaċja ta' tedizolid phosphate fi tfal u adolexxenti li għandhom inqas minn 18-il sena għadhom ma ġewx determinati s'issa.
English: • Infusion reactions (chills, shaking or shivering with fever, muscle pain, swelling of the face, weakness, fainting, shortness of breath, chest tightness and angina pectoris).
Maltese: • Reazzjonijiet għall-infużjoni (tertir, rogħda jew tregħid bid-deni, uġigħ fil-muskoli, nefħa tal wiċċ, dgħjufija, ħass ħażin, qtugħ ta' nifs, għafis fis-sider u anġina pectoris).
English: These effects showed evidence of reversibility and occurred at plasma tedizolid exposure levels (AUC) ≥6-fold greater than the plasma exposure associated with the human therapeutic dose.
Maltese: Dawn l-effetti wrew evidenza ta' reversibbiltà u seħħew f'livelli ta' espożizzjoni għal tedizolid filplażma (AUC) ≥6-darbiet aktar mill-espożizzjoni fil-plażma assoċjata mad-doża terapewtika talbniedem.
English: The Cmax and AUC of tedizolid increased approximately dose proportionally within the single oral dose range of 200 mg to 1,200 mg and across the intravenous dose range of 100 mg to 400 mg. Steady-state concentrations are achieved within 3 days and indicate modest active substance accumulation of approximately 30% following multiple once-daily oral or intravenous administration as predicted by a half-life of approximately 12 hours.
Maltese: Konċentrazzjonijiet fi stat fiss jintlaħqu fi żmien 3 ijiem u jindikaw akkumulu modest tas-sustanza attiva ta' madwar 30% wara għoti orali jew ġol-vina multiplu darba kuljum kif imbassar minn half-life ta' madwar 12-il siegħa.
English: No dose adjustment is necessary for co-administered CYP3A4 substrates during treatment with Sivextro.
Maltese: Mhux meħtieġ aġġustament fid-doża ta' sustrati ta' CYP3A4 mogħtija waqt trattament b'Sivextro.
English: - are allergic to other medicines belonging to the group “oxazolidinones” (e.g., linezolid, cycloserine).
Maltese: - inti allerġiku/a għal mediċini oħrajn li jagħmlu parti mill-grupp “oxazolidinones” (eż. linezolid,
English: Rash
Maltese: Nawsja
English: Serotonergic effects at doses of tedizolid phosphate up to 30-fold above the human equivalent dose did not differ from vehicle control in a mouse model that predicts brain serotonergic activity.
Maltese: L-effetti serotonerġiċi b'dożi ta' tedizolid phosphate sa 30 darba aktar mid-doża ekwivalenti tal bniedem ma kinux differenti mill-kontroll bis-sustanza li fiha tinġarr is-sutanza attiva f'mudell ta' ġurdien li jbassar l-attività serotonerġika tal-moħħ.
English: Tedizolid phosphate should be administered with caution in patients known to be hypersensitive to other oxazolidinones since cross-hypersensitivity may occur.
Maltese: Matul trattament b'tedizolid phosphate, fi ftit individwi ġie osservat tnaqqis fil-plejtlits, tnaqqis flemoglobina u tnaqqis fin-newtrofili.
English: The antibacterial activity of tedizolid is mediated by binding to the 50S subunit of the bacterial ribosome resulting in inhibition of protein synthesis.
Maltese: tedizolid hija medjata bit-twaħħil mas-subunità 50S tar-ribosoma batterjali li tirriżulta f'inibizzjoni tas-sintesi tal-proteina.
English: Sivextro 200 mg powder for concentrate for solution for infusion
Maltese: Sivextro 200 mg trab għal konċentrat għal soluzzjoni għall-infużjoni
English: In embryo-foetal studies, tedizolid phosphate was shown to produce foetal developmental toxicities in mice and rats.
Maltese: Fi studji tal-embriju u tal-fetu, tedizolid phosphate ntwera li jipproduċi tossiċitajiet fl-iżviluppp tal-fetu fil-ġrieden u l-firien.
English: Haematochezia Retching
Maltese: FULJETT TA' TAGĦRIF
English: Less than 3% of tedizolid phosphate administered dose is excreted as active tedizolid.
Maltese: Inqas minn 3% tad-doża mogħtija ta' tedizolid phosphate tiġi eliminata bħala tedizolid attiv.
English: 4.5 Interaction with other medicinal products and other forms of interaction
Maltese: Interazzjoni ma' prodotti mediċinali oħra u forom oħra ta' interazzjoni Interazzjonijiet farmakokinetiċi
English: CDAD may range in severity from mild diarrhoea to fatal colitis.
Maltese: CDAD tista' tvarja fil-gravità tagħha minn dijarea ħafifa għal kolite fatali.
English: Rash erythematous Rash generalised Acne
Maltese: • Ħakk madwar il-ġisem kollu
English: Renal and urinary disorders
Maltese: Dermatofitożi Kandidjażi orali
English: In a 1-month immunotoxicology study in rats, repeated oral dosing of tedizolid phosphate was shown to significantly reduce splenic B cells and T cells and reduce plasma IgG titers.
Maltese: Fi studju immunotossikoloġiku ta' xahar fil-firien, dożaġġ orali ripetut ta' tedizolid phospate ntwera li jnaqqas b'mod sinifikanti iċ-ċelluli B u ċ-ċelluli T tal-milsa u li jnaqqas it-titers IgG fil plażma.
English: These events have been observed with another member of the oxazolidinone class when administered over a duration exceeding that recommended for tedizolid phosphate.
Maltese: Dawn lavvenimenti ġew osservati b'membru ieħor tal-klassi ta' oxazolidinone meta jingħata għal perjodu itwal minn dak rakkomandat għal tedizolid phosphate.
English: When incubated with pooled human liver microsomes, tedizolid was stable suggesting that tedizolid is not a substrate for hepatic CYP450 enzymes.
Maltese: Meta ġie inkubat ma' ġabra ta' mikrosomi tal-fwied tal-bniedem, tedizolid kien stabbli, u dan jissuġġerixxi li tedizolid mhux substrat għall-enzimi epatiċi CYP450.
English: Each film-coated tablet contains 200 mg tedizolid phosphate.
Maltese: Kull pillola miksija b'rita fiha 200 mg tedizolid phosphate.
English: Certain side effects have been observed with another member of the oxazolidinone class when administered over a duration exceeding that recommended for Sivextro.
Maltese: Ċerti effetti sekondarji ġew osservati b'membru ieħor tal-klassi ta' oxazolidinone meta jingħata fuq perjodu li jaqbeż dak rakkomandat għal Sivextro.
English: Arthralgia Muscle spasms Back pain Limb discomfort Neck pain
Maltese: Ikkuntattja lit-tabib, lill-ispiżjar jew lid-dipartiment tal-emerġenza tal-eqreb sptar malajr kemm jista'
English: The safety and efficacy of tedizolid phosphate when administered for periods longer than 6 days have not been established (see section 4.4).
Maltese: Is-sigurtà u l-effikaċja ta' tedizolid phosphate meta jingħata għal perjodi itwal minn 6 ijiem għadhom ma ġewx determinati (ara sezzjoni 4.4).
English: How to store Sivextro
Maltese: Ħalq xott
English: EMA/523990/2014 EMEA/H/C/001126
Maltese: EMEA/H/C/001126
English: It is available as capsules (5, 20, 100, 140, 180 and 250 mg).
Maltese: Jiġi bħala kapsuli (5, 20, 100, 140, 180 u 250 mg).
English: The full EPAR for Temozolomide Teva 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: Temozolomide Teva is a ‘generic medicine'.
Maltese: Temozolomide Teva huwa ‘mediċina ġenerika'.
English: The European Commission granted a marketing authorisation valid throughout the EU for Temozolomide Teva on 28 January 2010.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha għal Temozolomide Teva fit-28 ta' Jannar 2010.
English: • adults with newly diagnosed glioblastoma multiforme (an aggressive type of malignant glioma).
Maltese: • adulti li ġew dijanjostikati għall-ewwel darba bi glijoblastoma multiforme (tip aggressiv ta' tumur tal-moħħ).
English: This is a summary of the European public assessment report (EPAR) for Temozolomide Teva.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Temozolomide Teva.
English: The dose of Temozolomide Teva depends on body surface area (calculated using the patient's height and weight) and ranges from 75 to 200 mg per square metre, once a day.
Maltese: Id-doża tat-Temozolomide Teva tiddependi mis-superfiċje tal-ġisem (ikkalkolati mit-tul u l-piż talpazjent) u tvarja minn 75 sa 200 mg għal kull metru kwadru, darba kuljum.
English: Temozolomide Teva is a medicine that contains the active substance temozolomide.
Maltese: Temozolomide Teva huwa mediċina li fiha s-sustanza attiva temozolomide.
English: The active substance in Temozolomide Teva, temozolomide, belongs to a group of cancer medicines called alkylating agents.
Maltese: Is-sustanza attiva f'Temozolomide Teva, it-temozolomide, tappartjeni għal grupp ta' mediċini ta' kontra l-kanċer li jissejħu aġenti alkilanti.
English: • adults and children three years of age and over with malignant glioma such as glioblastoma multiforme or anaplastic astrocytoma, when the tumour has returned or got worse after standard treatment.
Maltese: • f'adulti u tfal minn tliet snin ‘il fuq li jbatu minn xi glijoma malinna bħall-glijoblastoma multiforme jew l-astroċitoma anaplastika, meta t-tumur tagħhom jerġa' jitfaċċa jew jiggrava wara l-kura standard.
English: The CHMP concluded that, in accordance with EU requirements, Temozolomide Teva has been shown to have comparable quality and to be bioequivalent to Temodal.
Maltese: Is-CHMP kkonkluda li, b'mod konformi mar-rekwiżiti tal-UE, Temozolomide Teva wera li għandu kwalità komparabbli u huwa bijoekwivalenti għal Temodal.
English: Because Temozolomide Teva is a generic medicine, studies have been limited to tests to determine that it is bioequivalent to the reference medicine, Temodal.
Maltese: Billi Temozolomide Teva huwa mediċina ġenerika, l-istudji ġew limitati għal testitjiet biex jiddeterminaw il-bijoekwivalenza tiegħu mal-mediċina ta' referenza, Temodal.
English: Why has Temozolomide Teva been approved?
Maltese: Għaliex ġie approvat Temozolomide Teva?
English: It is used to treat malignant glioma (brain tumours) in the following groups of patients:
Maltese: Jintuża biex ifejjaq il-glijoma malinna (tumuri fil-moħħ) fil-gruppi ta' dawn il-pazjenti:
English: Because Temozolomide Teva is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as the reference medicine.
Maltese: Billi Temozolomide Teva huwa mediċina ġenerika u huwa bijoekwivalenti għall-mediċina ta' referenza, il-benefiċċji u r-riskji jitqiesu li kienu l-istess bħal dawk tal-mediċina ta' referenza.
English: This means that Temozolomide Teva is similar to a ‘reference medicine' already authorised in the European Union (EU) called Temodal.
Maltese: Dan ifisser li Temozolomide Teva jixbah lill-‘mediċina ta' referenza' diġà awtorizzata fl-Unjoni Ewropea (UE) magħrufa bħala Temodal.
English: What are the benefits and risks of Temozolomide Teva?
Maltese: X'inhu l-benefiċċju u r-riskju ta' Temozolomide Teva?
English: What is Temozolomide Teva?
Maltese: Għal xiex jintuża Temozolomide Teva?
English: Temozolomide Teva should be used with caution in patients with severe liver problems or with kidney problems.
Maltese: Temozolomide Teva għandu jintuża bil-galbu f'pazjenti bi problemi serji filfwied jew bi problemi fil-kliewi.
English: In the body, temozolomide is converted to another compound called MTIC.
Maltese: Fil-ġisem it-temożolomur tinbidel f'kompost imsejjaħ MTIC.
English: How has Temozolomide Teva been studied?
Maltese: Kif ġie studjat Temozolomide Teva?
English: • digitalis (see section 4.4)
Maltese: • digitalis (ara sezzjoni 4.4)
English: EU/1/07/399/001 EU/1/07/399/002 EU/1/07/399/003 EU/1/07/399/004 EU/1/07/399/005 EU/1/07/399/006
Maltese: EU/1/07/399/001 EU/1/07/399/002 EU/1/07/399/003 EU/1/07/399/004
English: Distribution Desloratadine is moderately bound (83 % - 87 %) to plasma proteins.
Maltese: Distribuzzjoni Desloratadine jeħel b'mod moderat (83 % - 87 %) mal-proteini fil-plażma.
English: B-2220 Heist-op-den-Berg Belgium.
Maltese: B-2220 Heist-op-den-Berg Il-Belġju.
English: Abnormal behaviour, aggression
Maltese: Imġiba mhux normali, aggressjoni
English: Date of first authorisation: 30 July 2007 Date of latest renewal: 30 July 2012
Maltese: Data tal-ewwel awtorizzazzjoni: 30 ta' Lulju, 2007 Data tal-aħħar tiġdid: 30 ta' Lulju 2012
English: Aerinaze with alcohol
Maltese: Aerinaze mal-alkoħol
English: The half-life for desloratadine is 27.4 hours.
Maltese: Il-half-life ta' desloratadine hija 27.4 sigħat.
English: - Desloratadine and Pseudoephedrine sulphate:
Maltese: • Desloratadine u Pseudoephedrine sulphate:
English: • aggression
Maltese: • aggressjoni
English: EU/1/07/399/001 2 modified-release tablets EU/1/07/399/002 4 modified-release tablets EU/1/07/399/003 7 modified-release tablets EU/1/07/399/004 10 modified-release tablets EU/1/07/399/005 14 modified-release tablets EU/1/07/399/006 20 modified-release tablets
Maltese: EU/1/07/399/001 2 pilloli li jerħu l-mediċina b'mod modifikat EU/1/07/399/002 4 pilloli li jerħu l-mediċina b'mod modifikat EU/1/07/399/003 7 pilloli li jerħu l-mediċina b'mod modifikat EU/1/07/399/004 10 pilloli li jerħu l-mediċina b'mod modifikat EU/1/07/399/005 14-il pillola li jerħu l-mediċina b'mod modifikat EU/1/07/399/006 20 pillola li jerħu l-mediċina b'mod modifikat
English: System Organ Class
Maltese: Klassi tas-Sistemi u talOrgani
English: Gastrointestinal and genitourinary effects
Maltese: Effetti gastrointestinali u ġenitourinarji
English: Pack sizes of 2, 4, 7, 10, 14 and 20 tablets.
Maltese: Pakketti f'daqsijiet ta' 2, 4, 7, 10, 14 u 20 pillola.
English: In clinical trials involving 414 adults the most frequent of adverse reactions reported were insomnia (8.9 %), dry mouth (7.2 %) and headache (3.1 %).
Maltese: Fi provi kliniċi li fihom ħadu sehem 414 adult, l-aktar reazzjonijiet avversi rrappurtati kienu nuqqas ta' rqad (8.9%), ħalq xott (7.2%) u uġigħ ta' ras (3.1%).
English: MSD Danmark ApS Tlf: + 45 4482 4000 dkmail@merck.com
Maltese: Danmark MSD Danmark ApS Tlf: + 45 4482 4000 dkmail@merck.com
English: • irritability
Maltese: • irritabilità
English: Frequencies are defined as 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) and not known (cannot be estimated from the available data).
Maltese: Il-frekwenzi huma ddefiniti bħala 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) u mhux magħruf (ma tisax tittieħed stima mid-dejta disponibbli).
English: • anorexogenics or amphetamine-type psychostimulants
Maltese: • anoressoġeniċi jew psiko-stimulanti tat-tip amphetamine
English: Hyperkinesia, confusional state
Maltese: Iperkinesja, stat ta' konfużjoni
English: Following oral administration of Aerinaze for 14 days in normal healthy volunteers, steady-state conditions were reached on day 10 for desloratadine, 3-hydroxydesloratadine and pseudoephedrine sulphate.
Maltese: Wara li Aerinaze ittieħed orali għal 14-il jum f'voluntiera normali b'saħħithom, kondizzjonijiet ta' stat fiss intlaħqu f'jum 10 għal desloratadine, 3-hydroxydesloratadine u pseudoephedrine sulphate.
English: Not known: frequency cannot be estimated from the available data • abnormal behaviour
Maltese: Mhux magħruf: il-frekwenza ma tistax tiġi stmata mid-dejta disponibbli • imġiba mhux normali
English: The apparent half-life of pseudoephedrine sulphate is 7.9 hours.
Maltese: Il-half-life apparenti ta' pseudoephedrine sulphate hija 7.9 sigħat.