FrancophonIA/ELRC3.0 huggingface dataset:
English: Mayzent is a medicine used to treat adults with an advanced form of MS known as secondary progressive MS (MS).
Maltese: Mayzent huwa mediċina li tintuża biex tikkura adulti b'forma avvanzata ta' MS magħrufa bħala MS progressiva sekondarja (MS).
English: What are the risks associated with Mayzent?
Maltese: X'inhuma r-riskji assoċjati ma' Mayzent?
English: Mayzent was shown to be effective at delaying the progression of the disease in a 3-year main study involving 1,651 patients with secondary progressive MS, of whom 779 had active disease with a relapse within 2 years or other signs of inflammation in scans.
Maltese: Mayzent intwera li kien effettiv fl-ittardjar tal-progressjoni tal-marda fi studju ewlieni ta' 3 snin li involva 1,651 pazjent b'MS progressiva sekondarja, li minnhom 779 kellhom marda attiva b'rikaduta fi żmien sentejn jew sinjali oħra ta' infjammazzjoni fl-iskenns.
English: During the study, 25% of patients with active secondary progressive MS taking Mayzent had disease progression compared with 35% of patients taking placebo (a dummy treatment).
Maltese: Matul l-istudju, 25 % tal-pazjenti b'MS progressiva sekondarja attiva li kienu qed jieħdu Mayzent kellhom progressjoni tal-marda mqabbla ma' 35 % tal-pazjenti li kienu qed jieħdu lplaċebo (kura finta).
English: The active substance in Mayzent, siponimod, blocks the action of some receptors (targets) on cells called sphingosine-1-phosphate receptors, which are involved in the movement of lymphocytes (immune cells) around the body.
Maltese: Is-sustanza attiva f'Mayzent, is-siponimod, timblokka l-azzjoni ta' xi riċetturi (miri) fuq ċelloli msejħa riċetturi tal-isfingosin-1-fosfat, li huma involuti fil-moviment tal-limfoċiti (ċelloli immunitarji) madwar il-ġisem.
English: Treatment is started with a dose of 0.25 mg daily for two days.
Maltese: Il-kura tinbeda b'doża ta' 0.25 mg darbtejn kuljum.
English: The medicine must also not be used in patients who previously had certain severe infections (known as progressive multifocal leukoencephalopathy or cryptococcal meningitis).
Maltese: Il-mediċina lanqas ma għandha tintuża f'pazjenti li qabel kellhom ċerti infezzjonijiet severi (magħrufa bħala lewkoenċefalopatija multifokali progressiva jew meningitis cryptococcica).
English: As for all medicines, data on the use of Mayzent are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Mayzent hija ssorveljata kontinwament.
English: The company that markets Mayzent will ensure that doctors expected to prescribe the medicine receive educational materials, including a checklist covering the necessary screening, pre-treatment and longterm monitoring of patients.
Maltese: Il-kumpanija li tqiegħed fis-suq Mayzent se tiżgura li t-tobba li jkunu mistennija jippreskrivu l-mediċina jirċievu materjal edukattiv, inkluża lista ta' kontroll li tkopri l-iskrinjar meħtieġ, il-kura minn qabel u lmonitoraġġ fit-tul tal-pazjenti.
English: Disease progression was defined as worsening of the disease that is independent from a relapse and is maintained over at least 3 months, as assessed using a standard scale called EDSS.
Maltese: Il-progressjoni tal-marda kienet definita bħala waħda li sejra għall-agħar li hija indipendenti minn rikaduti u li tinżamm fuq perjodu ta' mill-inqas 3 xhur, kif ġie vvalutat bl-użu ta' skala standard imsejħa EDSS.
English: In MS, the immune system (the body's defences) attacks and damages the protective sheath around the nerves in the brain and spinal cord.
Maltese: Fl-MS, is-sistema immunitarja (id-difiżi tal-ġisem) tattakka u tagħmel ħsara lir-rita protettiva madwar in-nervituri fil-moħħ u fis-sinsla tad-dahar.
English: This is determined by the use of a blood or saliva test to measure the activity of the patient's liver enzyme CYP2C9.
Maltese: Dan jiġi ddeterminat bl-użu ta' test tad-demm jew tal-bżieq biex titkejjel l-attività tal-enzima tal-fwied tal-pazjent CYP2C9.
English: Mayzent was effective at delaying the progression of secondary progressive MS in patients with active disease; however, the beneficial effects of the medicine were not demonstrated in patients without an active disease.
Maltese: Mayzent kien effettiv fl-ittardjar tal-progressjoni ta' MS progressiva sekondarja f'pazjenti b'marda attiva; madankollu, l-effetti ta' benefiċċju tal-mediċina ma ntwerewx f'pazjenti mingħajr marda attiva.
English: Side effects reported with Mayzent are carefully evaluated and any necessary action taken to protect patients.
Maltese: L-effetti sekondarji rrappurtati b'Mayzent huma evalwati bir-reqqa u kull azzjoni meħtieġa hi meħuda biex tipproteġi lill-pazjenti.
English: Mayzent must also not be used in patients who have inherited a gene known as CYP2C9*3 from both parents, which makes them unable to process the medicine fast enough.
Maltese: Mayzent lanqas m'għandu jintuża f'pazjenti li jkunu wirtu ġene magħruf bħala CYP2C9*3 miż-żewġ ġenituri, li jagħmilhom mhux kapaċi jipproċessaw il-mediċina malajr biżżejjed.
English: The maintenance dose is either 1 mg or 2 mg daily, depending on how quickly the patient's body can process the medicine.
Maltese: Id-doża ta' manteniment hija jew 1 mg jew 2 mg kuljum, skont kemm il-ġisem tal-pazjent jista' jipproċessa malajr il-mediċina.
English: The side effects with Mayzent are similar to those with another medicine (fingolimod) for MS working in a similar way, and are considered acceptable.
Maltese: L-effetti sekondarji b'Mayzent huma simili għal dawk b'mediċina oħra (fingolimod) għal MS li jaħdmu b'mod simili, u huma kkunsidrati aċċettabbli.
English: For the full list of side effects and restrictions of Mayzent, see the package leaflet.
Maltese: Għal-lista sħiħa taleffetti sekondarji u r-restrizzjonijiet rrappurtati b'Mayzent, ara l-fuljett ta' tagħrif.
English: How does Mayzent work?
Maltese: Kif jintuża Mayzent?
English: What measures are being taken to ensure the safe and effective use of Mayzent?
Maltese: X'miżuri qegħdin jittieħdu biex jiġi żgurat l-użu sigur u effettiv ta' Mayzent?
English: E.g. baclofen.
Maltese: Eż. baclofen.
English: • antifungals, e.g. ketoconazole, voriconazole, fluconazole, itraconazole, pozaconazole
Maltese: • antifungali, eż. ketoconazole, voriconazole, fluconazole, itraconazole, pozaconazole
English: Azole antifungals
Maltese: Antifungali azole
English: • If the seizure does not stop within 10 minutes, call an ambulance.
Maltese: • Jekk l-aċċessjoni ma tiqafx fi żmien 10 minuti, ċempel għal ambulanza.
English: Muscle relaxants
Maltese: Rilassanti tal-muskoli
English: Date of latest renewal: 26 May 2016
Maltese: Data tal-aħħar tiġdid: 26 ta' Jista, 2016
English: • The active substance is midazolam
Maltese: • Is-sustanza attiva hi midazolam
English: • antibiotics, e.g. erythromycin, clarithromycin
Maltese: • antibijotiċi, eż. erythromycin, clarithromycin
English: Common: ≥ 1/100 to < 1/10
Maltese: ≥ 1/100 sa < 1/10
English: Anaesthetics and narcotic analgesics
Maltese: Anestetiċi u analġeżiċi narkotiċi
English: The initial and terminal elimination half-lives are 27 and 204 minutes, respectively.
Maltese: Il-half-lives tal-eliminazzjoni inizjali u terminali huma ta' 27 u 204 minuta, rispettivament.
English: Blue
Maltese: Blu
English: St John's Wort decreased plasma concentrations of midazolam by about 20-40% associated with a decrease in terminal half life of about 15-17%.
Maltese: St John's Wort naqqas il-konċentrazzjonijiet fil-plażma ta' midazolam b'madwar 20-40% flimkien ma' tnaqqis fil-half-life terminali ta' madwar 15-17%.
English: HIV Protease inhibitors
Maltese: Inibituri tal-HIV Protease
English: • St John's Wort (a herbal medicine).
Maltese: • St John's Wort (mediċina li ġejja mill-ħxejjex).
English: Uncommon: ≥ 1/1,000 to < 1/100
Maltese: Mhux komuni: ≥ 1/1,000 sa < 1/100 Rari ħafna:
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 05 September 2011
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 05 ta' Settembru, 2011
English: Anterograde amnesia**, ataxia**, dizziness**, headache**, seizure**, paradoxical reactions**
Maltese: Amnesija anterograda**, atassija**, sturdament**, uġigħ ta' ras**, aċċessjoni**, reazzjonijiet paradossali**
English: Approximately 96-98% of midazolam is bound to plasma proteins.
Maltese: Madwar 96-98% ta' midazolam jeħel mal-proteini tal-plażma.
English: Strengths 5 mg, 7.5 mg and 10 mg:
Maltese: Qawwiet 5 mg, 7.5 mg u 10 mg:
English: Calcium-channel blockers
Maltese: Imblokkaturi tal-kanal tal-calcium
English: Aggression**, agitation**, anger**, confusional state**, euphoric mood**, hallucination**, hostility**, movement disorder**, physical assault**
Maltese: Aggressjoni**, aġitazzjoni**, rabja**, stat ta' konfużjoni**, burdata ewforika**, alluċinazzjoni**, ostilità**, disturb filmoviment**, attakk fiżiku**
English: 10 years to < 18 years Orange
Maltese: 10 snin sa < 18-il sena Oranġjo
English: Flumazenil may be useful as an antidote.
Maltese: Flumazenil jista' jkun utli bħala antidot.
English: Midazolam is a derivative of the imidazobenzodiazepine group.
Maltese: Midazolam hu derivattiv tal-grupp ta' imidazobenzodiazepine.
English: • Temporary memory loss.
Maltese: • Telf temporanju tal-memorja
English: Cardiac insufficiency
Maltese: Insuffiċjenza kardijaka
English: At 30 and 60 minutes, significant elimination of midazolam has already occurred and therefore the increase in mean Cmax is less pronounced; 1.3 to 1.6 and 1.2 to 1.5 fold respectively.
Maltese: Wara 30 u 60 minuta, it-tneħħija sinifikanti ta' midazolam tkun diġà seħħet u għalhekk iż-żieda fis-Cmax medja tkun inqas notevoli; 1.3 sa 1.6 u 1.2 sa 1.5 darbiet rispettivament (ara sezzjoni 4.2).
English: Laryngo-tracheal insertion should be avoided to prevent accidental aspiration of the solution.
Maltese: L-inserzjoni laringotrakeali għandha tiġi evitata għal prevenzjoni ta' aspirazzjoni aċċidentali tas-soluzzjoni.
English: 2.5 mg 3 m < 1 yr
Maltese: 2.5 mg 3 xhur < 1 sena
English: • Severe liver problems.
Maltese: • Problemi severi tal-fwied.
English: Midazolam is excreted mainly by the renal route (60-80% of the injected dose) and recovered as glucuroconjugated alphahydroxy-midazolam.
Maltese: Midazolam jitneħħa primarjament mill-kliewi (60-80% tad-doża injettata) u jiġi rkuprat bħala glucuroconjugated alpha-hydroxy-midazolam.
English: Bradycardia**, cardiac arrest**, hypotension**, vasodilatation**
Maltese: Bradikardija**, waqfien kardijaku**, pressjoni baxxa**, vażodilatazzjoni**
English: Midazolam is hydroxylated by the cytochrome P4503A4 isozyme and the major urinary and plasma metabolite is alpha-hydroxy-midazolam.
Maltese: Midazolam jiġi idrossilat permezz tal-isożima ta' ċitokrom P4503A4, u l-metabolit maġġuri fl-awrina u l-plażma hu alpha-hydroxy-midazolam.
English: Midazolam may cause anterograde amnesia.
Maltese: Midazolam jista' jikkawża amnesija anterograda.
English: Examples include opiate derivatives (used as analgesics, antitussives or substitutive treatments), antipsychotics, other benzodiazepines used as anxiolytics or hypnotics, barbiturates, propofol, ketamine, etomidate; sedative antidepressants, non-recent H1-antihistamines and centrally acting antihypertensive medicinal products.
Maltese: Eżempji jinkludu derivattivi tal-opiates (jintużaw bħala analġeżiċi, mediċini kontra s-sogħla jew kuri sostituttivi), mediċini antipsikotiċi, benzodiazepines oħrajn użati bħala mediċini kontra l-ansjetà jew mediċini ipnotiċi, barbiturates, propofol, ketamine, etomidate; antidipressanti sedattivi, antistamini
English: Pharmacotherapeutic group: Psycholeptics, benzodiazepine derivatives ATC code: N05CD08.
Maltese: Mediċini psikolettiċi, derivattivi ta' benzodiazepine, Kodiċi ATC:
English: • The seizure does not stop within 10 minutes
Maltese: • L-aċċessjoni ma tiqafx fi żmien 10 minuti
English: Medicinal products that induce CYP3A4
Maltese: Prodotti mediċinali li jinduċu CYP3A4
English: Dopaminergic medicinal products
Maltese: Prodotti mediċinali dopaminerġiċi
English: The terminal half-life decreased by about 50-60%.
Maltese: Il-half-life terminali naqset b'madwar 50-60%.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list)) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: Ir-rekwiżiti tar-rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikati fuq il-portal elettroniku Ewropew tal-mediċini.
English: The absolute bioavailability of oromucosal midazolam is about 75% in adults.
Maltese: Il-bijodisponibilità assoluta tal-għoti ta' midazolam millmukuża tal-ħalq hi ta' madwar 75% f'persuni adulti.
English: Exposure following a second dose in the same seizure episode Simulated exposure data show that the overall AUC approximately doubles when a second dose is administered at 10, 30 and 60 minutes following the first dose.
Maltese: Espożizzjoni wara t-tieni doża fl-istess episodju ta' aċċessjoni Dejta minn espożizzjoni simulata turi li l-AUC totali bejn wieħed u ieħor tirdoppja meta tingħata ttieni doża wara 10, 30 u 60 minuta mill-għoti tal-ewwel doża.
English: In 4 rectal diazepam controlled studies and one study versus intravenous diazepam, in a total of 688 children, cessation of visible signs of seizures within 10 minutes was observed in 65% to 78% of children receiving oromucosal midazolam.
Maltese: F'4 studji kkontrollati dwar diazepam mogħti mir-rektum u studju wieħed kontra diazepam mogħti ġol-vina, f'total ta' 688 tifel u tifla, ġie osservat il-waqfien ta' sinjali viżibbli ta' attakki ta' aċċessjonijiet fi żmien 10 minuti f'65% sa 78% tat-tfal li kienu qed jirċievu midazolam mill-mukuża tal-ħalq.
English: AUC0-inf (ng.h/ml) Cmax (ng/ml) 10 mg 10 yrs < 18 yrs AUC0-inf (ng.h/ml) Cmax (ng/ml)
Maltese: 10 mg 10 snin < 18-il sena AUC0-inf (ng.h/ml) Cmax (ng/ml)
English: • antiepileptics, (for treating epilepsy) e.g. phenytoin
Maltese: • mediċini antiepilettiċi, (għall-kura tal-epilessija) eż. phenytoin
English: Always check with them if you are not sure.
Maltese: F'każijiet rari ħafna in-nifs jista' jieqaf.
English: 7.5 mg 5 yrs <10 yrs
Maltese: 7.5 mg 5 snin < 10 snin
English: • anti-ulcer medicines, e.g. cimetidine, ranitidine and omeprazole
Maltese: • mediċini kontra l-ulċeri, eż. cimetidine, ranitidine u omeprazole
English: 3 months to less than 1 year: 2.5 mg - yellow labelled packaging 1 year to less than 5 years: 5 mg - blue labelled packaging 5 years to less than 10 years: 7.5 mg - purple labelled packaging 10 years to less than 18 years: 10 mg - orange labelled packaging The dose is the full contents of one oral syringe.
Maltese: 3 xhur sa inqas minn sena: 2.5 mg - ippakkjar b'tikketta safra Sena sa inqas minn 5 snin: 5 mg - ippakkjar b'tikketta blu 5 snin sa inqas minn 10 snin: 7.5 mg - ippakkjar b'tikketta vjola 10 snin sa inqas minn 18-il sena: 10 mg - ippakkjar b'tikketta oranġjo Id-doża hi l-kontenut sħiħ ta' siringa orali waħda.
English: Fluconazole and itraconazole both increased the plasma concentrations of intravenous midazolam by 2 to 3-fold associated with an increase in terminal half-life by 2.4-fold for itraconazole and 1.5-fold for fluconazole.
Maltese: Fluconazole u itraconazole t-tnejn żiedu l-konċentrazzjonijiet fil-plażma ta' midazolam mogħti ġolvini bid-doppju sa 3 darbiet aktar assoċjati ma' żieda fil-half-life terminali bi 2.4 darbiet għal itraconazole u 1.5 darbiet għal fluconazole.
English: Pharmacodynamic Drug-Drug Interactions (DDI)
Maltese: Interazzjonijiet Farmakodinamiċi bejn Mediċina u Oħra (DDI)
English: 7 days of 600 mg once daily decreased the plasma concentrations of intravenous midazolam by about 60%.
Maltese: 7 ijiem ta' 600 mg darba kuljum naqqas il-konċentrazzjonijiet fil-plażma ta' midazolam mogħti ġolvini b'madwar 60%.
English: Hydrochloric acid (for pH adjustment and conversion of midazolam to the hydrochloride salt) Sodium hydroxide (for pH adjustment)
Maltese: Hydrochloric acid (għal aġġustament tal-pH u l-konverżjoni ta' midazolam għall-hydrochloride salt) Sodium hydroxide (għal aġġustament tal-pH)
English: 5 mg 1 yr < 5 yrs
Maltese: 5 mg 1 sena < 5 snin
English: Other medicines and BUCCOLAM
Maltese: TAL-PRODOTT MEDIĊINALI BUCCOLAM
English: INFORMATION IN BRAILLE BUCCOLAM 10 mg
Maltese: BUCCOLAM 10 mg
English: For detailed instructions on how to administer the medicinal product, see section 6.6.
Maltese: Għal struzzjonijiet dettaljati fuq l-amministrazzjoni tal-prodott mediċinali, ara sezzjoni 6.6.
English: A second dose at 10 minutes results in a significant increase in mean Cmax of between 1.7 to 1.9 fold.
Maltese: It-tieni doża wara 10 minuti tirriżulta f'żieda sinifikanti fis-Cmax medja ta' bejn 1.7 sa 1.9 darbiet.
English: What BUCCOLAM looks like and contents of the pack 3 months to less than 1 year: 2.5 mg - yellow labelled packaging 1 year to less than 5 years: 5 mg - blue labelled packaging 5 years to less than 10 years: 7.5 mg - purple labelled packaging 10 years to less than 18 years: 10 mg - orange labelled packaging
Maltese: Kif jidher BUCCOLAM u l-kontenut tal-pakkett 3 xhur sa inqas minn sena: 2.5 mg - ippakkjar b'tikketta safra Sena sa inqas minn 5 snin: 5 mg - ippakkjar b'tikketta blu 5 snin sa inqas minn 10 snin: 7.5 mg - ippakkjar b'tikketta vjola 10 snin sa inqas minn 18-il sena: 10 mg - ippakkjar b'tikketta oranġjo
English: INFORMATION IN BRAILLE BUCCOLAM 7.5 mg
Maltese: BUCCOLAM 7.5 mg
English: 3 to 6 months hospital setting
Maltese: 3 sa 6 xhur fi sfond ta' sptar
English: BUCCOLAM 2.5 mg oromucosal solution BUCCOLAM 5 mg oromucosal solution BUCCOLAM 7.5 mg oromucosal solution BUCCOLAM 10 mg oromucosal solution
Maltese: 2.5 mg soluzzjoni għall-mukuża tal-ħalq BUCCOLAM 5 mg soluzzjoni għall-mukuża tal-ħalq BUCCOLAM 7.5 mg soluzzjoni għall-mukuża tal-ħalq BUCCOLAM 10 mg soluzzjoni għall-mukuża tal-ħalq
English: BUCCOLAM is contraindicated in patients with severe hepatic impairment (see section 4.3).
Maltese: BUCCOLAM hu kontraindikat f'pazjenti b'indeboliment serju tal-fwied (ara sezzjoni 4.3).
English: Treatment of prolonged, acute, convulsive seizures in infants, toddlers, children and adolescents (from 3 months to < 18 years).
Maltese: Kura ta' attakki ta' aċċessjonijiet akuti u konvulżivi u fit-tul fi trabi, tfal żgħar, tfal u adolexxenti (minn 3 xhur sa <18-il sena).
English: Midazolam decreases the minimum alveolar concentration (MAC) of inhalation anaesthetics.
Maltese: Midazolam inaqqas il-konċentrazzjoni minima alveolari (MAC) ta' mediċini anestetiċi li jittiedu mannifs.
English: • narcotic analgesics (very strong pain killers), e.g. fentanyl
Maltese: • analġesiċi narkotiċi (mediċini qawwija ħafna kontra l-uġigħ), eż. fentanyl
English: The free base is a lipophilic substance with low solubility in water.
Maltese: Il-bażi libera hi sustanza lipofilika b'solubilità baxxa fl-ilma.
English: BUCCOLAM may increase the effect of some muscle relaxants e.g. baclofen (causing increased drowsiness).
Maltese: BUCCOLAM jista' jżid l-effett ta' xi rilassanti tal-muskoli, eż. baclofen (u jikkawża żieda fin-ngħas)
English: Sedation, amnesia, impaired attention and impaired muscular function may adversely affect the ability to drive, ride a bicycle or use machines.
Maltese: Sedazzjoni, amnesija, indeboliment fl-attenzjoni u indeboliment fil-funzjoni muskolari jistgħu jaffettwaw b'mod avvers il-kapaċità li persuna ssuq vettura, issuq rota jew tuża l-magni.
English: 10 years to < 18 years
Maltese: 10 snin sa <18-il sena
English: Very rare: Apnoea**, dyspnea**, laryngospasm**, respiratory arrest**
Maltese: Apnea**, qtugħ ta' nifs**, larinġospażmu**, waqfien respiratorju**
English: BUCCOLAM 5 mg, 7.5 mg, 10 mg oromucosal solution 2 years
Maltese: BUCCOLAM 5 mg, 7.5 mg, 10 mg soluzzjoni għall-mukuża tal-ħalq
English: Altered elimination of midazolam
Maltese: Eliminazzjoni mibdula ta' midazolam
English: Simulated pharmacokinetic parameters for the recommended posology in children aged 3 months to less than 18 years, based on a population pharmacokinetic study are provided in tabulated format below:
Maltese: Parametri farmakokinetiċi simulati għall-pożoloġija rakkomandata fi tfal li kellhom minn 3 xhur sa inqas minn 18-il sena, ibbażati fuq studju dwar il-farmakokinetika tal-popolazzjoni, huma pprovduti f'format tabulat hawn taħt:
English: The fraction of the dose extracted by the liver has been estimated to be 30-60%.
Maltese: Il-porzjon tad-doża meħuda mill-fwied ġiet stmata li hi bejn 30-60%.
English: • An allergy to midazolam, benzodiazepines (such as diazepam) or any of the other ingredients of this medicine (listed in section 6)
Maltese: • Allerġija għal midazolam, benzodiazepines (bħal diazepam) jew għal xi sustanzi oħra ta' din il mediċina (elenkati fis-sezzjoni 6)
English: A single dose of diltiazem increased the plasma concentrations of intravenous midazolam by about 25% and the terminal half-life was prolonged by 43%.
Maltese: Doża waħda ta' diltiazem żiedet il-konċentrazzjonijiet fil-plażma ta' midazolam mogħti ġol-vini b'madwar 25% u l-half-life terminali twalet bi 43%.
English: INFORMATION IN BRAILLE BUCCOLAM 5 mg
Maltese: BUCCOLAM 5 mg
English: Depending on the specific St John's Wort extract, the CYP3A4-inducing effect may vary.
Maltese: Skont l-estratt speċifiku ta' St John's Wort, leffett li jinduċi CYP3A4 jista' jvarja.
English: Special attention should be paid to respiratory and cardiovascular functions in intensive care.
Maltese: Għandha tingħata attenzjoni speċjali lil funzjonijiet respiratorji u kardjovaskulari f'każ ta' kura intensiva.
English: Dosage
Maltese: Medja
English: The bioavailability of oromucosal midazolam has been estimated at 87% in children with severe malaria and convulsions.
Maltese: Il-bijodisponibilità ta' midazolam mogħti millmukuża tal-ħalq ġiet stmata li hi 87% fi tfal b'malarja severa u konvulżjonijiet.
English: • xanthines (used to treat asthma)
Maltese: • xanthines (jintużaw għall-kura tal-ażżma)
English: Erythromycin resulted in an increase in the plasma concentrations of intravenous midazolam by about 1.6 to 2 -fold associated with an increase of the terminal half-life of midazolam by 1.5 to 1.8-fold.
Maltese: Erythromycin irriżulta f'żieda tal-konċentrazzjonijiet fil-plażma ta' midazolam mogħti ġol-vini b'madwar 1.6 darbiet sad-doppju assoċjata ma' żieda fil-half-life terminali ta' midazolam b'1.5 sa 1.8 darbiet.
English: PHARMACEUTICAL FORM Oromucosal solution Clear colourless solution pH 2.9 to 3.7
Maltese: GĦAMLA FARMAĊEWTIKA Soluzzjoni għall-mukuża tal-ħalq Soluzzjoni ċara u bla kulur pH 2.9 sa 3.7
English: Midazolam belongs to a group of medicines known as benzodiazepines.
Maltese: Midazolam jappartjeni għal grupp ta' mediċini magħrufa bħala benzodiazepines.
English: Ulcer-healing medicinal products
Maltese: TAL-PRODOTT MEDIĊINALI
English: Given the higher metabolite to parent drug ratio in younger children, a delayed respiratory depression as a result of high active metabolite concentrations in the 3-6 months age group cannot be excluded.
Maltese: Minħabba l-proporzjon ogħla tal-metaboliti meta mqabbel mal-mediċina prinċipali fi tfal iżgħar, ma jistax jiġi eskluż tnaqqis respiratorju ttardjat b'riżultat tal-konċentrazzjonijiet għoljin tal-metabolit attiv fil-grupp ta' età ta' 3-6 xhur.
English: The elimination half-life in patients with chronic renal failure is similar to that in healthy volunteers.
Maltese: Il-half-life tal-eliminazzjoni f'pazjenti b'insuffiċjenza kronika tal-kliewi hi simili għal dik f'voluntiera b'saħħithom.
English: The frequency and severity of adverse drug reactions reported for Oromucosal midazolam during published clinical trials were similar to the adverse drug reactions reported in the comparative group using rectal diazepam.
Maltese: Ilfrekwenza u s-severità ta' reazzjonijiet avversi tal-mediċina rrappurtati għal midazolam mogħti millmukuża tal-ħalq waqt provi kliniċi ippubblikati kienu simili għar-reazzjonijiet avversi tal-mediċina rrappurtati fil-grupp komparattiv bl-użu ta' diazepam mogħti mir-rektum.