FrancophonIA/ELRC3.0 huggingface dataset:
English: Microscopic changes in skeletal muscle were minimal (approximately 0.05% of myofibres affected) and at the higher doses were accompanied by elevations in CPK.
Maltese: Tibdil mikroskopiku fil-muskoli skeletriċi kienu minimi (madwar 0.05% fil-mijofibri affettwati) u b'dożi ogħla seħħew flimkien ma' żiediet fis-CPK.
English: However, daptomycin can cross the placenta in pregnant rats (see section 5.2).
Maltese: Madankollu, daptomycin jista' jgħaddi minn ġolplaċenta fil-firien waqt it-tqala (ara sezzjoni 5.2).
English: Among these failures six patients treated with Cubicin and one patient treated with vancomycin were infected with Staphylococcus aureus that developed increasing MICs of daptomycin on or following therapy (see “Mechanisms of resistance” above).
Maltese: Fost dawn il-fallimenti sitt pazjenti kkurati bi Cubicin u pazjent wieħed ikkurat b'vancomycin kienu infettati bi Staphlococcus aureus li żviluppa żieda fl-MIC's ta' daptomycin waqt jew wara t-terapija (ara “Mekkaniżmi ta' reżistenza” hawn fuq).
English: The pharmacokinetics of daptomycin were not significantly altered by aztreonam.
Maltese: Il-farmakokinetika ta' daptomycin ma kinitx mibdula b'mod sinjifikanti b'aztreonam.
English: Not known*: Eosinophilic pneumonia
Maltese: Pulmonite Eosinofilika1**, sogħla
English: Due to limited clinical experience (see table and footnotes below) Cubicin should only be used in adult patients with any degree of renal impairment (CrCl < 80 ml/min) when it is considered that the expected clinical benefit outweighs the potential risk.
Maltese: Minħabba esperjenza klinika limitata (ara t-tabella u n-noti f'qiegħ it-tabella hawn taħt) Cubicin għandu jintuża biss f'pazjenti adulti bi kwalunkwe grad ta' indeboliment renali (CrCl <80 ml/min) meta jkun ikkunsidrat li l-benefiċċju kliniku mistenni jkun akbar mir-riskju li jista' jkun hemm.
English: Subjects achieving clinical success (Clinical Response of “Cure” or “Improved”) and microbiological success (pathogen-level response of “Eradicated” or “Presumed Eradicated”) are classified as overall therapeutic success.
Maltese: Streptococcus pyogenes a Individwi li jiksbu suċċess kliniku (Rispons kliniku ta' “Kura” jew “Imtejjeb”) u suċċess mikrobijoloġiku (rispons fil-livell tal-patoġenu ta' “Eradikat” jew “Preżunt Eradikat”) jiġu klassifikati bħala li jiksbu suċċess terapewtiku globali.
English: For the 2-minute intravenous injection, the storage time of the reconstituted solution in the vial (see section 6.6) at 25°C must not exceed 12 hours (or 48 at 2°C - 8°C).
Maltese: Għall-injezzjoni ta' 2 minuti fil-vina, il-ħin tal-ħażna tas-soluzzjoni rikostitwita fil-kunjett (ara sezzjoni 6.6) f'temperatura ta' 25°C ma jridx jaqbeż it-12-il siegħa (jew l-48 siegħa f'temperatura ta' 2°C - 8°C).
English: Cubicin 500 mg powder for solution for injection or infusion daptomycin
Maltese: TAL-PRODOTT MEDIĊINALI Cubicin 500 mg trab għal soluzzjoni għall-injezzjoni jew għall-infużjoni daptomycin
English: In in vitro studies, daptomycin was not metabolised by human liver microsomes.
Maltese: Studji in vitro wrew li daptomycin ma kienx immetabolizzat mill-mikrosomi tal-fwied fil-bnedmin.
English: One ml provides 50 mg of daptomycin after reconstitution with 7 ml of sodium chloride 9 mg/ml (0.9%) solution.
Maltese: Millilitru wieħed jipprovdi 50 mg daptomycin wara li jkun imħallat ma' 7 ml ta' sodium chloride 9 mg/ml (0.9%) soluzzjoni.
English: After a single 4 mg/kg dose of Cubicin, total clearance of daptomycin in children 7-11 years of age with Gram-positive infection was higher than in adolescents, whereas elimination half-life was shorter.
Maltese: Wara doża waħda ta' 4 mg/kg ta' Cubicin, it-tneħħija totali ta' daptomycin fit-tfal b'età ta' 7 snin-11-il sena b'infezzjoni Gram-pożittiva kienet ogħla milli fladolexxenti, filwaqt li l-half-life ta' eliminazzjoni kienet iqsar.
English: Cubicin 350 mg powder for solution for injection or infusion daptomycin
Maltese: Cubicin 350 mg trab għal soluzzjoni għall-injezzjoni jew għall-infużjoni daptomycin
English: Uncommon: Vertigo
Maltese: Vertigo
English: Animal studies do not indicate direct or indirect harmful effects with respect to fertility (see section 5.3).
Maltese: Studji f'annimali ma wrewx effetti diretti jew indiretti tossiċi fuq il-fertilità (ara sezzjoni 5.3).
English: Paediatric patients with cSSTI
Maltese: Suċċess Kliniku f'cSSTI Pedjatrika
English: Draw 7 ml of sodium chloride 9 mg/ml (0.9%) solution for injection into a syringe using a sterile transfer needle that is 21 gauge or smaller diameter, or a needleless device, then slowly inject through the centre of the rubber stopper into the vial pointing the needle towards the wall of the vial.
Maltese: Iġbed 7 ml ta' soluzzjoni għall-injezzjoni ta' sodium chloride 9 mg/ml (0.9%) ġo siringa bl-użu ta' labra ta' trasferiment sterili b'dijametru ta' 21 gejġ jew inqas, jew f'apparat mingħajr labra, imbagħad injettaha bil-mod min-nofs tat-tapp tal-gomma fil-kunjett u mmira l-labra lejn il-ġenb tal-kunjett.
English: Draw 10 ml of sodium chloride 9 mg/ml (0.9%) solution for injection into a syringe using a sterile transfer needle that is 21 gauge or smaller diameter, or a needleless device, then slowly inject through the centre of the rubber stopper into the vial pointing the needle towards the wall of the vial.
Maltese: Iġbed 10 ml ta' soluzzjoni għall-injezzjoni ta' sodium chloride 9 mg/ml (0.9%) ġo siringa bl-użu ta' labra ta' trasferiment sterili b'dijametru ta' 21 gejġ jew inqas, jew f'apparat mingħajr labra, imbagħad injettaha bil-mod min-nofs tat-tapp tal-gomma fil-kunjett u mmira l-labra lejn il-ġenb tal-kunjett.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu
Maltese: Informazzjoni ddettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu
English: In all populations the clinical success rates were comparable between the daptomycin and SOC treatment arms, supporting the primary efficacy analysis in the ITT population.
Maltese: Fil-popolazzjonijiet kollha, ir-rati tassuċċess kliniku kienu komparabbli bejn it-trattament b'daptomycin u SOC, b'sostenn għall-analiżi taleffikaċja primarja fil-popolazzjoni ITT.
English: Enterococcal infections
Maltese: Infezzjonijiet u infestazzjonijiet
English: Comparable exposure (AUC and Cmax) was demonstrated in healthy adult subjects following administration of daptomycin as a 30-minute intravenous infusion or as a 2-minute intravenous injection.
Maltese: Esponiment kumparabbli (AUC u Cmax) intwera f'individwi adulti f'saħħithom wara l-għoti ta' daptomycin bħala infużjoni ta' 30 minuta fil-vina jew injezzjoni ta' 2 minuti fil-vina.
English: Dosage Regimen
Maltese: Mekkaniżmi ta' reżistenza
English: One ml provides 50 mg of daptomycin after reconstitution with 10 ml of sodium chloride 9 mg/ml (0.9%) solution.
Maltese: Millilitru wieħed jipprovdi 50 mg daptomycin wara li jkun imħallat ma' 10 ml ta' sodium chloride 9 mg/ml (0.9%) soluzzjoni.
English: Methicillin-susceptible Staphylococcus aureus (MSSA)
Maltese: Staphylococcus aureus suxxettibbli għall-methicillin (MSSA, Methicillin-susceptible Staphylococcus aureus)
English: If a focus of infection other than cSSTI or RIE is identified after initiation of Cubicin therapy consideration should be given to instituting alternative antibacterial therapy that has been demonstrated to be efficacious in the treatment of the specific type of infection(s) present.
Maltese: Jekk jiġi identifikat fokus ta' infezzjoni li ma jkunx cSSTI jew RIE wara li tinbeda terapija bi Cubicin, għandu jiġi kkunsidrat li tingħata terapija antibatterika oħra li jkun intwera li hi effikaċi fil-kura tat-tip ta' infezzjoni(jiet) speċifika(ċi) li jkun hemm.
English: At lower dose levels (25 mg/kg/day), mild and reversible clinical signs of twitching and one incidence of muscle rigidity were observed without any effects on body weight.
Maltese: F'livelli ta' dożi aktar baxxi (25 mg/kg/jum), ġew osservati sinjali kliniċi ħfief u riversibbli ta' ġbid għall-għarrieda u inċidenza waħda ta' ebusija tal-muskoli mingħajr kwalunkwe effett fuq il-piż tal-ġisem.
English: Very rare serious side effects (may affect up to 1 in 10,000 people) A hypersensitivity reaction (serious allergic reaction including anaphylaxis, angioedema, drug rash with eosinophilia and systemic symptoms (DRESS)) has been reported, in some cases during administration of Cubicin.
Maltese: Effetti sekondarji serji rari ħafna (jistgħu jaffettwaw sa persuna waħda f'kull 10,000) Reazzjoni ta' sensittività eċċessiva (reazzjoni allerġika serja li tinkludi anafilassi, anġjoedima, reazzjoni għall-mediċina b'eosinofilja u sintomi sistemiċi (DRESS)) kienet irrappurata f'xi każijiet waqt l-għoti ta' Cubicin.
English: VIAL
Maltese: LOTT
English: Cubicin should only be reconstituted with sodium chloride 9 mg/ml (0.9%).
Maltese: Cubicin għandu jiġi rrikostitwit biss b'9 mg/ml (0.9%) sodium chloride.
English: • It cannot be ruled out that those patients with CPK greater than 5 times upper limit of normal at baseline may be at increased risk of further increases during daptomycin therapy.
Maltese: • Ma jistax jiġi eskluż li dawk il-pazjenti li jkollhom CPK ogħla minn 5 darbiet il-limitu ta' fuq tan-normali fil-linja bażi jista' jkollhom riskju akbar ta' aktar żidiet waqt it-terapija b'daptomycin.
English: Cubicin is also used in adults to treat infections in the tissues that line the inside of the heart (including heart valves) which are caused by a type of bacteria called Staphylococcus aureus.
Maltese: Cubicin jintuża wkoll f'adulti biex jikkura infezzjonijiet fit-tessuti li jiksu l-parti ta' ġewwa tal-qalb (inklużi l-valvuli tal-qalb) li huma kkawżati minn tip ta' batterji imsejħa Staphylococcus aureus.
English: When administration is by injection reconstitute with 0.9% sodium chloride only.
Maltese: Meta jingħata bħala injezzjoni rrikostitwixxi b'0.9% sodium chloride biss.
English: In neonatal dogs, daptomycin caused marked clinical signs of twitching, muscle rigidity in the limbs, and impaired use of limbs, which resulted in decreases in body weight and overall body condition at doses ≥50 mg/kg/day and necessitated early discontinuation of treatment in these dose groups.
Maltese: Fi klieb tat-twelid, daptomycin ikkawża sinjali kliniċi qawwija ta' ġbid għall-għarrieda, ebusija talmuskoli fir-riġlejn u użu indebolit tar-riġlejn, li wasslu għal tnaqqis fil-piż tal-ġisem u għal kundizzjoni tal-ġisem globali f'dożi ta' ≥50 mg/kg/jum u rriżultaw fil-ħtieġa ta' twaqqif bikri tattrattament f'dawn il-gruppi ta' dożi.
English: If not used immediately, in-use storage times are the responsibility of the user and would normally not be longer than 24 hours at 2°C - 8°C unless reconstitution /dilution has taken place in controlled and validated aseptic conditions.
Maltese: Jekk ma jintużax millewwel, il-ħinijiet tal-ħażna waqt l-użu huma r-responsabbiltà ta' min qed jużah u normalment ma jkunux aktar minn 24 siegħa f'temperatura bejn 2°C - 8°C, sakemm r-rikostituzzjoni/dilwizzjoni ma tkunx saret f'post b'kundizzjonijiet asettiċi kkontrollati u validati.
English: Secondary objectives included: Clinical outcome based on the blinded Evaluator's assessment of clinical response (success [cure, improved], failure, or nonevaluable) at the TOC Visit; and Microbiological response (success, failure, or non-evaluable) based on evaluation of Baseline infecting pathogen at TOC.
Maltese: L-iskopijiet sekondarji kienu jinkludu: riżultat Kliniku abbażi tal-istima tarrispons kliniku (suċċess [kura, titjib], falliment, jew ma jistax jiġi evalwat) mill-Evalwatur li ma kienx jaf liema sustanza qed tintuża fil-Vista tat-TOC; u rispons Mikrobijoloġiku (suċċess, falliment, jew ma jistax jiġi evalwat) abbażi tal-valutazzjoni tal-patoġenu li qed jinfetta fil-linja bażi f'TOC.
English: ITT (intention to treat) Population RIE
Maltese: Popolazzjoni ITT (intenzjoni li tiġi kkurata)
English: Following administration of a single 4 mg/kg or 6 mg/kg intravenous dose of daptomycin over a 30minute period to adult subjects with various degrees of renal impairment, total daptomycin clearance
Maltese: Wara li ngħatat doża waħda ta' 4 mg/kg jew 6 mg/kg daptomycin minn ġol-vina lill-individwi adulti fuq medda ta' 30 minuta li kellhom gradi varji ta' indeboliment renali, it-tneħħija totali ta' daptomycin (CL) naqset u l-esponiment sistemiku (AUC) żdied ma tnaqqis fil-funzjoni tal-kliewi (tneħħija talkrejatinina).
English: The active substance in Cubicin powder for solution for injection or infusion is daptomycin.
Maltese: Is-sustanza attiva fi Cubicin trab għal soluzzjoni għall-injezzjoni jew għall-infużjoni hija daptomycin.
English: Creatine phosphokinase (CPK) levels must be measured at baseline and at regular intervals (at least weekly) during treatment (see section 4.4).
Maltese: Il-livelli tal-creatine phosphokinase (CPK) għandhom jitkejlu fil-linja bażi u f'intervalli regolari (millinqas darba fil-ġimgħa) matul it-trattament (ara sezzjoni 4.4).
English: A 50 mg/ml concentration of Cubicin 350 mg powder for injection is obtained by reconstituting the lyophilised product with 7 ml of sodium chloride 9 mg/ml (0.9%) solution for injection.
Maltese: Konċentrazzjoni ta' 50 mg/ml ta' Cubicin 350 mg trab għall-injezzjoni tinkiseb billi tirrikostitwixxi lprodott lajofilizzat b'7 ml ta' soluzzjoni għall-injezzjoni ta' 9 mg/ml (0.9%) sodium chloride.
English: Chemical and physical in-use stability on the reconstituted solution in the vial has been demonstrated for 12 hours at 25°C and up to 48 hours if stored under refrigeration (2°C - 8°C).
Maltese: L-istabbiltà kimika u fiżika waqt l-użu tas-soluzzjoni mħallta fil-kunjett intweriet għal 12-il siegħa f'temperatura ta' 25°C u sa 48 siegħa jekk tinħażen fi friġġ (2°C - 8°C).
English: A 50 mg/ml concentration of Cubicin 500 mg powder for infusion is obtained by reconstituting the lyophilised product with 10 ml of sodium chloride 9 mg/ml (0.9%) solution for injection.
Maltese: Konċentrazzjoni ta' 50 mg/ml ta' Cubicin 500 mg trab għall-injezzjoni tinkiseb billi tirrikostitwixxi lprodott lajofilizzat b'10 ml ta' soluzzjoni għall-injezzjoni ta' 9 mg/ml (0.9%) sodium chloride.
English: Renal impairment Daptomycin is eliminated primarily by the kidney.
Maltese: Daptomycin huwa eliminat l-aktar mill-kilwa.
English: How to store Cubicin
Maltese: Kif taħżen Cubicin
English: In addition, there is a potential for a pharmacodynamic interaction to occur during coadministration due to additive renal effects.
Maltese: Minbarra hekk, hemm potenzjal ta' interazzjoni farmakodinamika meta jingħataw flimkien minħabba effetti renali addittivi.
English: Daptomycin is reversibly bound to human plasma proteins in a concentration independent manner.
Maltese: Daptomycin jintrabat b'mod riversibli mal-proteini tal-plażma fil-bniedem b'mod li ma jiddependix mill-konċentrazzjoni.
English: Daptomycin is primarily cleared by renal filtration and so plasma levels may be increased during coadministration with medicinal products that reduce renal filtration (e.g. NSAIDs and COX-2 inhibitors).
Maltese: Daptomycin jitneħħa l-aktar b'filtrazzjoni renali u għalhekk il-livelli fil-plażma jistgħu jiżdiedu meta jingħata flimkien ma' prodotti mediċinali li jnaqqsu l-filtrazzjoni renali (eż NSAIDs u inibituri ta' COX-2).
English: Whenever possible, Cubicin should be administered following the completion of dialysis on dialysis days (see section 5.2).
Maltese: Kull meta jkun possibbli, fil-ġranet tad-dijalisi Cubicin għandu jiġi amministrat wara li titlesta d-dijalisi (ara sezzjoni 5.2).
English: Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3).
Maltese: Studji f'annimali ma wrewx effetti diretti jew indiretti tossiċi fuq it-tqala, fuq l-iżvilupp tal-embriju/fetu, ħlas jew żvilupp wara ttwelid (ara sezzjoni 5.3).
English: Slowly remove the appropriate reconstituted liquid (50 mg daptomycin/ml) from the vial using a new sterile needle that is 21 gauge or smaller in diameter by inverting the vial in order to allow the solution to drain towards the stopper.
Maltese: Bil-mod neħħi l-likwidu rrikostitwit li suppost (50 mg daptomycin/ml) mill-kunjett bl-użu ta' labra sterili ġdida li għandha dijametru ta' 21 gejġ jew inqas billi taqleb il-kunjett ta' taħt fuq sabiex tħalli s-soluzzjoni tinżel lejn it-tapp.
English: In paediatric patients under 7 years old receiving a 9-12 mg/kg dose, daptomycin should be administered over 60 minutes.
Maltese: F'pazjenti pedjatriċi li għandhom inqas minn 7 snin li jkunu qed jirċievu doża ta' 9-12-il mg/kg, daptomycin għandu jingħata fuq perjodu ta' 60 minuta.
English: The Marketing Authorisation Holder shall ensure that all laboratories expected to perform Cubicin susceptibility testing are provided with: - Summary of Product Characteristics - Laboratory susceptibility testing leaflet
Maltese: Id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq għandu jara li l-laboratorji kollha mistennija li jwettqu testijiet tas-suxxettibilità ta' Cubicin jingħatalhom:
English: For Dilution:
Maltese: Mhux komuni:
English: Cubicin is available in packs containing 1 vial or 5 vials.
Maltese: Cubicin jiġi f'pakketti li jkun fihom kunjett 1 jew 5 kunjetti.
English: Cubicin 350 mg powder for solution for injection or infusion Cubicin 500 mg powder for solution for injection or infusion
Maltese: Cubicin 350 mg trab għal soluzzjoni għall-injezzjoni jew għall-infużjoni Cubicin 500 mg trab għal soluzzjoni għall-injezzjoni jew għall-infużjoni
English: Plasma exposures achieved with these doses were consistent with those achieved in the adult cSSTI study (following 4 mg/kg once daily in adults).
Maltese: Esponimenti fil-plażma li nkisbu b'dawn id-dożi kienu konsistenti ma' dawk li nkisbu fl-istudju cSSTI fl-adulti (wara 4 mg/kg darba kuljum fl-adulti).
English: False prolongation of prothrombin time (PT) and elevation of international normalised ratio (INR) have been observed when certain recombinant thromboplastin reagents are utilised for the assay (see also section 4.5).
Maltese: Interazzjoni tal-mediċina/tat-testijiet fil-laboratorju Kienu osservati titwil falz fil-ħin ta' prothrombin (PT) u żieda tal-proporzjon internazzjonali normalizzat (INR) meta ċerti sustanzi rikombinanti tat-thromboplastin jintużaw għall-analiżi (ara wkoll sezzjoni 4.5).
English: Aniseed EMA/305345/2016
Maltese: EMA/305345/2016
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom20 September 2016 EMA/305345/2016
Maltese: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom20 ta' Settembru 2016
English: Aniseed
Maltese: Frotta tal-Anisi
English: Aniseed medicines must not be used in patients who are allergic to aniseed or to plants of the Apiaceae family (Umbelliferae) (caraway, celery, coriander, dill, fennel) or anethole.
Maltese: Il-mediċini tal-frotta tal-anisi m'għandhomx jintużaw f'pazjenti li huma allerġiċi għall-frotta tal-anisi jew għal pjanti tal-familja Apiaceae (Umbelliferae) (karwija, karfus, kosbor, xibt, bużbież) jew anethole.
English: Aniseed is the common name for the fruit of the plant Pimpinella anisum L.
Maltese: Frotta tal-anisi huwa l-isem komuni għall-frotta tal-pjanta Pimpinella anisum L.
English: The HMPC conclusions on the use of these aniseed medicines for indigestion complaints and coughs are based on their ‘traditional use'.
Maltese: Il-konklużjonijiet tal-HMPC dwar l-użu tal-mediċini tal-frotta tal-anisi għal ilmenti ta' indiġestjoni u sogħla huma bbażati fuq l-"użu tradizzjonali" tagħhom.
English: In its assessment, the HMPC considered laboratory studies which showed aniseed preparations to have a relaxant effect on muscles of the gut and airways.
Maltese: Fil-valutazzjoni tiegħu, l-HMPC ikkunsidra għadd ta' studji tal-laboratorji li wrew li l-preparazzjonijiet tal-frotta tal-anisi għandhom effett rilassanti fuq il-muskoli tal-imsaren u l-passaġġi tal-arja.
English: Further information on the HMPC assessment of aniseed medicines, including details of the Committee's conclusions, can be found under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Maltese: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: What are the risks associated with aniseed medicines?
Maltese: X'inhuma r-riskji assoċjati mal-mediċini tal-frotta tal-anisi?
English: Other information about aniseed medicines
Maltese: Aktar informazzjoni dwar il-mediċini tal-frotta tal-anisi
English: The HMPC conclusions only cover the dried herbal substance (dried aniseed) and aniseed preparations which are obtained by drying and comminuting (reducing into tiny pieces) or crushing the fruit.
Maltese: Il-konklużjonijiet tal-HMPC ikopru biss is-sustanza tal-ħxejjex imnixxfa (frotta tal-anisi mnixxfa) u preparazzjonijiet tal-frotta tal-anisi li huma miksuba billi l-frotta titnixxef u tindaħan (f'biċċiet iżgħar) jew titgħaffeġ.
English: Further information on the risks associated with these aniseed medicines, including the appropriate precautions for their safe use, can be found in the monograph under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Maltese: Aktar informazzjoni dwar ir-riskji assoċjati ma' dawn il-mediċini tal-frotta tal-anisi, inklużi lprekawzjonijiet xierqa għall-użu sigur tagħhom, tinsab fil-monografija taħt it-tab ‘Id-dokumenti kollha' (‘All Documents') fil-websajt tal-Aġenzija:
English: What is aniseed?
Maltese: tas-saħħa.
English: Any applications for the licensing of medicines containing aniseed have to be submitted to the national authorities responsible for medicinal products, which will assess the application for the herbal medicine and take into account the scientific conclusions of the HMPC.
Maltese: Kwalunkwe applikazzjoni għal-liċenzjar ta' mediċini li fihom il-frotta tal-anisi għandha titressaq lillawtoritajiet nazzjonali responsabbli għall-prodotti mediċinali, li ser jivvalutaw l-applikazzjoni għallmediċina tal-ħxejjex u jqisu l-konklużjonijiet xjentifiċi tal-HMPC.
English: Aniseed medicines should only be used in adults and adolescents over the age of 12 years and should not be taken for longer than two weeks.
Maltese: Il-mediċini tal-frotta tal-anisi għandhom jintużaw biss fl-adulti u fl-adolexxenti li għandhom ‘il fuq minn 12-il sena u ma għandhomx jittieħdu għal aktar minn ġimagħtejn.
English: Differences*
Maltese: Differenzi*
English: EMEND oral suspension
Maltese: EMEND suspensjoni orali
English: Adolescents (aged 12 through 17 years)
Maltese: Popolazzjoni pedjatrika Adolexxenti (b'età minn 12 sa 17-il sena)
English: OUTER PACKAGING - STANDARD PACK (CARTON)
Maltese: PAKKETT TA' BARRA - PAKKETT STANDARD (KARTUNA)
English: Tél: +33 (0) 1 80 46 40 40
Maltese: MSD France Tél: +33 (0) 1 80 46 40 40
English: Cmax was 1.6 ± 0.36 µg/mL and 1.4 ± 0.22 µg/mL on Days 1 and 3, respectively.
Maltese: Cmax kien 1.6 ± 0.36 µg/mL u 1.4 ± 0.22 µg/mL f'Jiem 1 u 3, rispettivament.
English: Pharmacotherapeutic group: Antiemetics and antinauseants, ATC code: A04AD12
Maltese: Anti-emetiċi u mediċini ta' kontra t-tqallih, Kodiċi ATC: A04AD12
English: Fosaprepitant regimen (N =1,106) **
Maltese: (N =1,106) **
English: Aprepitant 40 mg orally (N=541)
Maltese: Aprepitant 40 mg mill-ħalq (N=541)
English: Aprepitant displays non-linear pharmacokinetics.
Maltese: Aprepitant juri farmakokinetika mhux lineari.
English: CYP3A4 interactions
Maltese: Interazzjonijiet ta' CYP3A4
English: Capsule shell (125 mg) Gelatin
Maltese: Il-qoxra tal-kapsula (125 mg) Gelatin
English: medicalinfo.nl@merck.com
Maltese: msd-medizin@merck.com
English: The mean absolute oral bioavailability of aprepitant is 67 % for the 80 mg capsule and 59 % for the 125 mg capsule.
Maltese: Il-biodisponibilità orali assoluta medja ta' aprepitant hija 67 % għall-kapsula ta' 80 mg u 59 % għallkapsula ta' 125 mg.
English: Standard dose of 5-HT3 antagonists.
Maltese: Doża standard tal antagonisti ta' 5-HT3.
English: Summary of the safety profile The safety profile of aprepitant was evaluated in approximately 6,500 adults.
Maltese: Sommarju tal-profil ta' sigurtà Il-profil tas-sigurtà ta' aprepitant ġie evalwat f'madwar 6,500 adult.