FrancophonIA/ELRC3.0 huggingface dataset:
English: For the full list of all side effects and restrictions with Xolair, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet kollha bi Xolair, ara l-fuljett ta' tagħrif.
English: In children aged between six and 12 years, the most common side effects (seen in more than 1 patient in 10) are headache and pyrexia (fever).
Maltese: Fit-tfal ta' bejn sitt snin u 12-il sena, l-effetti sekondarji l-aktar komuni (li dehru f'iktar minn pazjent wieħed minn 10) kienu l-uġigħ ta' ras u l-piressija (deni).
English: 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea.europa.eu http://www.emea.europa.eu EMEA 2008 Reproduction and/or distribution of this document is authorised provided the source is acknowledged
Maltese: (44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea.europa.eu http://www.emea.europa.eu EMEA 2008 Reproduction and/or distribution of this document is authorised provided the source is acknowledged
English: EMEA/V/C/092
Maltese: EMEA/V/C/092 RAPPORT TA' VALUTAZZJONI
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) PUREVAX RCCH EPAR summary for the public
Maltese: PUBBLIKA EWROPEW (EPAR) PUREVAX RCCH Sommarju ta' l-EPAR għall-pubbliku
English: Other information about Purevax RCCh:
Maltese: Informazzjoni oħra dwar Purevax RCCh:
English: • chlamydiosis (a flu-like illness caused by the bacterium C. felis).
Maltese: • chlamydiosis (marda tixbah lill-influwenza kkawżata mill-batterju C. felis).
English: • attenuated (weakened) feline rhinotracheitis herpesvirus (FHV F2 strain),
Maltese: • rhinotracheitis herpesvirus felin (razza FHV F2) imdgħajjef,
English: The effectiveness of Purevax RCCh has been studied in several trials in laboratory conditions where cats were vaccinated and infected with virulent herpesvirus, calicivirus or C. felis.
Maltese: L-effettività ta' Purevax PRC ġiet studjata f'diversi studji fil-kundizzjonijiet tal-laboratorji fejn il-qtates tlaqqmu u ġew infettati bil-herpesvirus, calicivirus jew C. felis.
English: The benefit-risk balance may be found in module 6 of this EPAR.
Maltese: Il-bilanċ bejn il-benefiċċju-riskju jista' jinstab fil modulu 6 ta' dan l-EPAR.
English: If you want more information on the basis of the CVMP recommendations, read the Scientific Discussion (also part of the EPAR).
Maltese: Jekk tixtieq iktar informazzjoni abbażi tar-rakkomandazzjonijiet tal-CVMP, aqra d-Diskussjoni Xjentifika (parti wkoll mill-EPAR).
English: • feline viral rhinotracheitis (a flu-like illness caused by a herpesvirus),
Maltese: • rinotrakeite virali felina (marda tixbah lill-influwenza kkawżata mill-herpesvirus),
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Purevax RCCh exceed the risks for the active immunisation of cats aged eight weeks or older against the diseases listed above, and recommended that Purevax RCCh be given a marketing authorisation.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għal Użu Veterinarju (CVMP) ikkonkluda li l-benefiċċji ta' Purevax RCCh jisbqu r-riskji għall-immunizzazzjoni attiva ta' qtates li għandhom tmien ġimgħat jew aktar kontra l-mard elenkat fuq, u rrakkomanda li Purevax RCCh jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: • feline calicivirosis (a flu-like illness with inflammation of the mouth caused by a calicivirus),
Maltese: • calicivirosis felin (marda tixbah lill-influwenza bl-infjammazzjoni tal-ħalq ikkawżata mill-calicivirus),
English: Occasionally, cats will develop temporary apathy (loss of interest in surroundings) and anorexia (loss of appetite), as well as hyperthermia (elevated body temperature) lasting for one or two days.
Maltese: Xi drabi, il-qtates jiżviluppaw apatija (nuqqas ta' interess fl-ambjent ta' madwarhom) u anoressija (nuqqas ta' apatija), kif ukoll temperatura għolja li ddum jum jew tnejn.
English: What is Purevax RCCh?
Maltese: X'inhu Purevax RCP?
English: In the field study of basic vaccination there was an increase in antibodies against feline rhinotracheitis herpesvirus and calicivirus infection.
Maltese: Fl-istudju dwar it-tilqima bażika kien hemm żieda fl-antikorpi kontra l-infezzjonijiet mill-vajrusis felini tal-herpesvirus, tar-rinotrakeite u tal-calicivirus.
English: Purevax RCCh is a lyophilisate (freeze-dried pellet) and solvent that are made up into a suspension for injection.
Maltese: Purevax RCP hu lyophilisate (solidu imnixxef) u solvent li jinħallu f'sospensjoni għall injezzjoni.
English: The cat should be revaccinated for all components one year after the first vaccination course, then every year for rhinotracheitis, calicivirosis and chlamydiosis.
Maltese: Il-qattus għandu jitlaqqam mill-ġdid għall-komponenti kollha sena wara l-ewwel kors ta' tilqim, u mbagħad kull sena għar-rhinotracheitis, il-calicivirosis u l-chlamydiosis.
English: They included young and adult cats of various breeds, but not young kittens.
Maltese: Ġew inklużi diversi razez ta' qtates żgħażagħ u adulti, iżda mhux frieħ.
English: Purevax RCCh is a vaccine.
Maltese: Purevax PRC huwa vaċċin.
English: Why has Purevax RCCh been approved?
Maltese: Għaliex ġie approvat Purevax RCCh?
English: Purevax RCCh is a vaccine containing the following active substances:
Maltese: Purevax RCP huwa vaċċin li fih dawn is-sustanzi attivi:
English: In the study looking at booster vaccination, antibody levels against rhinotracheitis herpesvirus, calicivirus infection and C. felis remained stable at a high level or increased slightly.
Maltese: Fl-istudju li ħares lejn it-tilqima bil booster, il-livelli ta' l-antikorpi kontra l-herpesvirus tar-rinotrakeite, infezzjoni tal-calicivirus u C. felis baqgħu stabbli jew żdiedu bi ftit.
English: • inactivated (killed) calicivirosis antigens (FCV 431 and G1 strains),
Maltese: • antiġeni tal-calicivirosis (razez FCV 431 u G1) inattivati (maqtula), • Chlamydophila felis imdgħajjef (razza 905).
English: It was not possible to detect a rise in antibodies against C. felis because of high levels of antibodies in the cats at the beginning of the study.
Maltese: Ma kienx possibbli li wieħed jara jekk hemmx żieda fl-antikorpi kontra C. felis minħabba livelli għoljin ta' antikorpi fil-qtates fil-bidu ta' l-istudju.
English: This summary was last updated on 25 January 2008.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar fil-25 ta' Jannar 2008.
English: This document is a summary of the European Public Assessment Report.
Maltese: Dan id-dokument huwa sommarju tar-Rapport ta' Valutazzjoni Pubblika Ewropew.
English: For a full list of the side-effects reported with Purevax RCCh, see the Package Leaflet.
Maltese: Għal-lista sħiħa ta' effetti sekondarji rrapportati ma' Purevax PRC, ara l-Fuljett ta' Tagħrif.
English: Purevax RCCh is used to vaccinate cats from the age of 8 weeks against the following diseases:
Maltese: Purevax RCP jintuża fit-tlaqqim ta' qtates mill-età ta' 8 ġimgħat 'il fuq kontra dawn il mardiet:
English: If the cat has high levels of antibodies inherited from the mother, the first vaccination should be delayed until 12 weeks of age.
Maltese: Jekk il-qattus ikollu livelli għoljin ta' antikorpi li jintirtu mill-omm, l-ewwel tilqima għandha titbiegħed sa ma jkollu 12-il ġimgħa.
English: How has Purevax RCCh been studied?
Maltese: Kif ġie studjat Purevax RCP?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Purevax RCCh to MERIAL on 23 February 2005.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fuq is-suq madwar l-Unjoni Ewropea, għal Purevax RCCh lil MERIAL fit-23 ta' Frar 2005.
English: After Purevax RCCh has been made up, 1 ml is injected under the skin.
Maltese: Wara li Purevax PRC jinħall, 1 ml minnu jiġi injettat taħt il-ġilda.
English: In laboratory conditions Purevax RCCh was demonstrated to provide protection against the diseases listed above.
Maltese: F'kundizzjonijiet tal-laboratorju, intwera li Purevax PRC jipprovdi protezzjoni kontra lmardiet imsemmija hawn fuq.
English: Organ/System (Frequency)
Maltese: Organu/Sistema (Frekwenza)
English: Al. Jana Pawła II nr 15
Maltese: Jana Pawła II nr 15
English: Tolerance
Maltese: Toleranza
English: (See section 4.5).
Maltese: (ara sezzjoni 4.4).
English: Dependence
Maltese: Dipendenza
English: Date of latest renewal: 12 March 2009
Maltese: Data tal-aħħar tiġdid: 12 ta' Marzu 2009
English: s r.o.. Trnavská cesta 50
Maltese: Trnavská cesta 50
English: Sonata contains lactose.
Maltese: Sonata fih lactose.
English: Одрин 71-75, ет.2, ап 7
Maltese: Одрин 71-75, ет.2, ап 7 1303 София
English: Meda Pharma SIA Narva mnt 11D EE - 10151 Tallinn, Eesti Tel. + 372 6261 025
Maltese: Narva mnt 11D EE - 10151 Tallinn, Eesti Tel. + 372 6261 025
English: Co. Meath
Maltese: Meath
English: 51063 Cologne Germany
Maltese: 51063 Cologne Il-Ġermanja
English: MEDA PHARMA SAS 25 Bd. de l´Amiral Bruix F-75016 Paris Tél : +33 156 64 10 70
Maltese: Bd. de l´Amiral Bruix F-75016 Paris Tél : +33 156 64 10 70
English: United Kingdom Meda Pharmaceuticals Ltd. Skyway House Parsonage Road Takeley
Maltese: Skyway House Parsonage Road Takeley
English: Meda AB Pipers väg 2A S-170 09 Solna Sweden
Maltese: Meda AB Pipers väg 2 170 09 Solna L-Isvezja
English: Severe respiratory insufficiency
Maltese: Insuffiċjenza respiratorja gravi
English: PVC / PVDC aluminium blister packages of 7, 10, 14 capsules in perforated unit-dose blisters.
Maltese: Pakketti b'folji ta' aluminju PVC / PVDC b'7, 10 u 14-il kapsula f'folji perforati b'doża waħda.
English: Immune system disorders Very rare:
Maltese: Disturbi fis-Sistema Immuni Rari ħafna:
English: Capsule, hard.
Maltese: Kapsuli iebsin.
English: Meda Pharma S.p.A. Viale Brenta, 18 I-20139 Milano Tel: +39 02 57 416 1
Maltese: Viale Brenta, 18 I-20139 Milano Tel: +39 02 57 416 1
English: Amnesia
Maltese: Amnesija
English: Respiratory insufficiency
Maltese: Insuffiċjenza respiratorja
English: Duration of treatment
Maltese: Tul tat-trattament
English: • Rare cases of severe allergic reactions have been reported.
Maltese: • Każijiet rari ta' reazzjonijiet allerġiċi severi ġew irrapportati.
English: Renal impairment
Maltese: Insuffiċjenza renali
English: Alfred Gera & Sons Ltd. 10, Triq il-Masġar Qormi QRM 3217 Tel: +356 2092 4000
Maltese: 10, Triq il-Masġar Qormi QRM 3217 Tel: +356 2092 4000
English: Psychiatric and “paradoxical” reactions
Maltese: Reazzjonijiet Psikjatriċi u “paradossali”
English: INFORMATION IN BRAILLE Sonata 10 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Sonata 10 mg
English: Paediatric patients Sonata is contraindicated in children and adolescents under 18 years of age (see section 4.3).
Maltese: Sonata huwa kontraindikat fi tfal u adolexxenti b'età inqas minn 18-il sena (ara sezzjoni 4.3).
English: Common (1/100 to <1/10)
Maltese: Mhux komuni (>1/1000 sa <1/100) Rari (>1/10,000 sa <1/1,000)
English: INFORMATION IN BRAILLE Sonata 5 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Sonata 5 mg
English: BATCH NUMBER Lot
Maltese: NUMRU TAL LOTT Lott
English: Uncommon:
Maltese: Mhux komuni :
English: The single dose pharmacokinetics of zaleplon were studied in patients with mild (creatinine clearance 40 to 89 ml/min) and moderate (20 to 39 ml/min) renal impairment, and in patients on dialysis.
Maltese: Id-doża unika farmakokinetika ta' zaleplon kienet studjat fuq pazjenti li kellhom indeboliment renali bejn ħafif (tneħħija ta' krejatinina 40 sa 89 ml/min) u moderat (20 sa 39 ml/min), u f'pazjenti li kienu fuq dijalisi.
English: Uncommon side effects include: dizziness; weakness; reduced coordination of movements; unsteadiness and/or falls (ataxia); decreased concentration; apathy; restlessness; depression; agitation; irritability; confusion; abnormal thinking and behaviour (extroversion that seems out of character, decreased inhibition, aggressiveness, rages, delusion, depersonalisation, psychosis); nightmares; hallucinations; double vision or other sight problems; increased sensitivity to noise (hyperacusis); smell disorder (parosmia); speech disorders, including slurred speech; numbness, e.g. in the extremities (hypoaesthesia); nausea; decreased appetite; increased sensitivity to light (sunlight, UV light); feeling vaguely ill (malaise).
Maltese: Effetti sekondarji mhux komuni jinkludu: sturdament; dgħjufija; tnaqqis ta' ko-ordinazzjoni fil movimenti; nuqqas li wieħed jkun sod / jew waqgħat (ataxia); nuqqas ta' konċentrazzjoni; apatija; nuqqas ta' sabar; dipressjoni,agitazzjoni; burdati ħżiena; konfużjoni, ħsibijiet u mġiba mhux tas-soltu (soċjabbli mhux tas-soltu, nuqqas ta' inibizzjoni, aggressjoni, rabja, delużjoni, nuqqas ta' personalità, barra minn sensih); ħmir il-lejl; alluċinazzjoniet,viżjoni doppja jew problemi tal-vista; żjieda fissensittiva għall-ħsejjes (hyperacusis); disordni fix-xamm (parosmia); diskors mħawwad, inkluż diskors mhux ċar); nuqqas ta' sensazzjoni, eż. fl-estremitajiet (hypoaesthesia); taqlib ta' l-istonku;
English: Metabolism and nutrition disorders Uncommon:
Maltese: Disturbi fil-metaboliżmu u n-nutrizzjoni Mhux komuni:
English: Fifty-seven percent (57%) of the dose is recovered in urine in the form of 5-oxo-zaleplon and its glucuronide metabolite, an additional 9% is recovered as 5-oxo-desethylzaleplon and its glucuronide metabolite.
Maltese: Sebgħa u ħamsin fil-mija (57%) tad-doża hi miġbura mill-awrina fil-forma ta' 5-oxo-zaleplon u filmetaboliti glukuronidi tiegħu, 9% oħra huma miġbura bħala 5-oxo-desethylzaleplon u fil-metaboliti gluċuronidi tiegħu.
English: Zaleplon is primarily metabolised by aldehyde oxidase to form 5-oxo-zaleplon.
Maltese: Zaleplon hu primarjalment metaboliżżat b'aldehyde oxidase għall-forma 5-oxo-zaleplon.
English: Sonata with food, drink and alcohol
Maltese: Sonata ma' ikel, xorb u alkoħol
English: Zaleplon is excreted in the form of inactive metabolites, mainly in the urine (71%) and faeces (17%).
Maltese: Zaleplon joħroġ f'forma ta' metaboliti inattivi, l-aktar fl-awrina (71%) u fl-iskart tal-ġisem (17%).
English: The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Maltese: Rapporti Perjodiċi Aġġornati dwar is-Sigurtà Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq għandu jippreżenta rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott f'konformità mar-rekwiżiti mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u ppubblikati fuq il-portal elettroniku Ewropew tal-mediċini.
English: Pipers väg 2A
Maltese: Meda AB Pipers väg 2
English: Severe renal impairment is contraindicated (see section 4.3.
Maltese: Indeboliment renali sever huwa kontraindikat (ara sezzjoni 4.3). 4.3 Kontraindikazzjonijiet
English: Sonata has major influence on the ability to drive and use machines.
Maltese: Sonata, hemm il-possibilità li tista' ssir dipendenti fuqhom.
English: At least 71% of the orally-administered dose is absorbed.
Maltese: Mill-anqas 71% tad-doża meħuda mill-ħalq hi assorbita.
English: Capsule core
Maltese: Il-qalba tal kapsula:
English: Severe renal impairment
Maltese: Insuffiċjenza epatika gravi Insuffiċjenza renali gravi
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Maltese: Pazjenti bi problemi ereditarji rari ta' intolleranza għal galactose, defiċjenza ta' Lapp lactase jew assorbiment ħażin ta' glucose-galactose m'għandhomx jieħdu din il-mediċina.
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Maltese: Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe wieћed mill-eċċipjenti elenkati fis sezzjoni 6.1.
English: The in vitro plasma protein binding is approximately 60%, suggesting little risk of active substance interaction due to protein binding.
Maltese: Il-proteini tal-plażma in vitro huma ta' madwar 60%, li jissuġġerixxu li hemm risku żgħir ta' azzjoni mediċinali reċiproka minħabba l-għaqda tal-proteini.
English: For adults, the recommended dose is 10 mg.
Maltese: Għall-adulti hija rrakkomandata doża ta' 10 mg.
English: Other medicines and Sonata
Maltese: Mediċini oħra u Sonata
English: Sonata 10 mg hard capsules, which contain a light blue powder, have a white cap and white body, with pink imprint “10 mg”.
Maltese: Sonata 10 mg kapsuli iebsin, li fihom trab blu ċar, għandhom ras bajda, u korp abjad, b'“10 mg” intaljati lewn roża.
English: Česká republika MEDA Pharma s.r.o.
Maltese: MEDA Pharma s.r.o.
English: Never drink alcohol while you are being treated with Sonata (see “Warnings and precautions”).
Maltese: Qatt tixrob l-alkoħol meta tkun qed tiġi ittratt b'Sonata (ara “Twissijiet u prekawzjonijiet”).
English: MEDA PHARMA Hungary Kereskedelmi Kft. H-1139 Budapest
Maltese: H-1139 Budapest
English: Co-administration of Sonata together with inducers of CYP3A4 such as rifampicin, carbamazepine and phenobarbitone, may result in a reduction of zaleplon's efficacy.
Maltese: L-amministrazzjoni ta' Sonata flimkien ma prodotti li jistimulaw CYP3A4 bħal ma hu rifampicin, carbamazepine, u phenobarbitone, jistgħu jirriżultaw f'nuqqas fl-effikaċja ta' zaleplon.
English: S-170 73 Solna
Maltese: S-170 09 Solna L-Isvezja
English: Ул.
Maltese: Tista'
English: Dr. Franje Tudmana 3 10431 Sveta Nedelja Tel: +385 1 3374 010
Maltese: Sveta Nedelja Tel: +385 1 3374 010
English: This can usually be avoided if you remain inactive for at least 4 hours after taking Sonata.
Maltese: Din tista' ħafna drabi tiġi evitata jekk iżżomm ruħek inattiv sa 4 sigħat wara li tieħu Sonata.
English: depersonalisation, hallucinations, depression, confusional state, apathy somnambulism
Maltese: apatija, konfużjoni, nuqqas ta' personalita`, dipressjoni, alluċinazzjoniet, sonnambuliżmu
English: In a fertility and reproductive performance study in rats, mortality and decreased fertility were observed in males and females at an oral zaleplon dose of 100 mg/kg/day (equivalent to 49-times the maximum recommended human dose (MRHD) of 20 mg on a mg/m2 basis).
Maltese: Fi studju dwar il-fertilità u l-ħila riproduttiva fil-firien, mortalità u fertilità mnaqqsa kienu osservati fl irġiel u fin-nisa b'doża orali ta' zaleplon ta' 100 mg/kg/jum (ekwivalenti għal 49 darba id-doża massima rakkomandata fil-bniedem (MRHD - maximum recommended human dose) ta' 20 mg fuq bażi ta' mg/m2).
English: See also below under Depression and Psychiatric and “paradoxical” reactions
Maltese: Ara wkoll taħt Amnesija, Dipressjoni u Reazzjonijiet Psikjatriċi u “paradossali”
English: The oxidative metabolites are further metabolised by conjugation via glucuronidation.
Maltese: Il-metaboliti ossidattiv huma mobilizzati aktar bl-għaqda via gluċuronidazzjoni.
English: The extent of exposure to zaleplon was similar among all groups.
Maltese: It-tul ta' żmien ta' dawk li kienu esposti għal zaleplon kien simili għall-gruppi kollha.
English: In embryofetal development studies, oral administration of zaleplon up to 100 mg/kg/day and 50 mg/kg/day to pregnant rats and rabbits, respectively, produced no evidence of teratogenicity (equivalent to 49- (rat) and 48-(rabbit) times the MRHD on a mg/m2 basis).
Maltese: Fi studji dwar l-iżvilupp tal-embriju u l-fetu, għoti orali ta' zaleplon sa 100 mg/kg/jum u 50 mg/kg/jum lil firien u fniek tqal, rispettivament, ma pproduċa l-ebda evidenza ta' teratoġeniċità (ekwivalenti għal 49 (far) u 48 (fenek ) darba l-MRHD fuq bażi ta' mg/m2).
English: In mild cases, symptoms include drowsiness, mental confusion, and lethargy, in more serious cases, symptoms may include ataxia, hypotonia, hypotension, respiratory depression, rarely coma and very rarely death.
Maltese: F'każijiet ħfief, is-sintomi jinkludu ngħas, konfużjoni mentali, u letarġija, f'każijiet aktar serji, is sintomi jistgħu jinkludu atassja, ipotonija, pressjoni baxxa, depressjoni respiratorja, rarament koma u rari ħafna mewt.
English: However, there is no clinical experience with the use of flumazenil as an antidote to a Sonata overdose.
Maltese: Flumazenil bħala antidotu għal doża eċċessiva ta' Sonata.
English: Pre-and postnatal growth of rats was reduced at the maternally toxic dose of 100 mg/kg/day.
Maltese: Tkabbir qabel u wara ttwelid tal-firien kien imnaqqas bid-doża tossika għall-omm ta' 100 mg/kg/jum.
English: България ТП Меда Фармасойтикалс
Maltese: Polska Meda Pharmaceuticals
English: Capsule shell gelatin, titanium dioxide (E171), sodium lauryl sulphate,
Maltese: Il-qoxra tal-kapsula: gelatin, titanium dioxide (E171), sodium lauryl sulphate.
English: Depression
Maltese: Dipressjoni
English: Side effects that may occur commonly: drowsiness; memory difficulties; sensations like tingling, e.g. in the extremities (paraesthesia); painful menstruation.
Maltese: Effetti sekondarji li jistgħu jseħħu b'mod komuni: ħedla; diffikultajiet fil-memorja; sensazzjonjiiet bħal tnemnim, eż. fl-estremitajiet (parasteżija); uġigħ mal-menstrwazzjoni.
English: Additionally, there was no pharmacokinetic interaction between zaleplon and venlafaxine (extended release).
Maltese: Barra dan, ma hemmx interazzjoni farmakokinetika bejn iż-zaleplon u venlafaxin (mneħħi fuq tul ta' żmien estiż).
English: Coadministration of a single zaleplon 10 mg dose and venlafaxine (extended release) 75 mg or 150 mg daily did not produce any interaction on memory (immediate and delayed word recall) or psychomotor performance (digit symbol substitution test).
Maltese: L-amministrazzjoni ta' doża unika ta' 10mg zaleplon u venlafaxin (mneħħi fuq tul ta' żmien estiż) 75 mg jew 150 mg kulljum ma jiproduċċux interazzjoni fuq il-memorja (immedjata jew ritardata fuq li wieħed jiftakar il-kliem) jew kif jaġixxi l-mekkaniżmu psikomatiku fl-individwu (f'test ta' bdil bejn numri u simboli).
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/.
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għallMediċini http://www.ema.europa.eu/.
English: Co-administration of Sonata with a single 800 mg dose of erythromycin, a strong, selective CYP3A4 inhibitor, produced a 34% increase in zaleplon's plasma concentrations.
Maltese: L-amministrazzjoni ta' Sonata ma' doża waħda 800 mg ta' erithromycin, li hu ta' tfixkil qawwi u selettiv ta' CYP3A4, ipproduċa żjieda ta' 34% fil-konċentrazzjonijiet tal-plażma ta' zaleplon.
English: Cimetidine, a non-specific moderate inhibitor of several hepatic enzymes including both aldehyde oxidase and CYP3A4, produced an 85% increase in plasma concentrations of zaleplon because it inhibited both the primary (aldehyde oxidase) and secondary (CYP3A4) enzymes responsible for zaleplon's metabolism.
Maltese: Iċ-ċimetidin, inibitur moderat mhux speċifikat ta' xi wħud mill-enżemi epatetiki aldeide ossidjat kif ukoll CYP3A4, ipproduċa żjieda 85% fil-konċentrazzjonijiet tal-plażma taż-zaleplon għaliex hi fixklet l-enżemi kemm enżimi primarji (aldeide ossidjat) kif ukoll sekondarji ta' (CYP3A4) li huma responabli għall-metaboliżmu zaleplon.
English: MARKETING AUTHORISATION NUMBERS EU/1/99/102/004-006
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/99/102/004-006
English: Chaussée de la Hulpe 166/ Terhulpsesteenweg 166 B-1170 Brussels Belgique/Belgien Tél/Tel: +32 2 5 04 08 11
Maltese: Luxembourg/Luxemburg MEDA Pharma S.A./N.V. Chaussée de la Hulpe 166/ Terhulpsesteenweg 166 B-1170 Brussels Belgique/Belgien Tél/Tel:
English: Sonata 5 mg hard capsules, which contain a light blue powder, have a light brown cap and white body, with gold imprint “5 mg”.
Maltese: Sonata, 5 mg kapsuli iebsin, li fihomtrab blu ċar, għandhom ras kannella ċara, u korp abjad, b'“5 mg” intaljati lewn id-deheb.
English: Tel: +420 234 064 203
Maltese: CZ 100 10 Praha 10 Tel: +420 234 064 203