FrancophonIA/ELRC3.0 huggingface dataset:
English: Athinas 22 & Apollonos Gerakas, Attikis, 15344 Greece
Maltese: Athinas 22 & Apollonos Gerakas, Attikis, 15344
English: PROTON PHARMA Anonymous Pharmaceutical Company, Achaias 4 and Trizoinias, Nea Kifissia 14564
Maltese: PROTON PHARMA Achaias 4 and Trizoinias, Nea Kifissia 14564
English: IZ NOE-Sued, Strasse 7, Obj.58D/1/2.OG, 2355 Wiener Neudorf, Austria
Maltese: IZ NOE-Sued, Straße 7, Obj.58D/1/2.OG 2355
English: BROS EPE Avgis & Gallinis 15, n. Kifissia,
Maltese: Avgis & Gallinis 15, n.
English: ZYDUS FRANCE 25, rue des Peupliers ZAC Les Hautes Pâtures - Parc d'Activités des Peupliers 92000 Nanterre FRANCE
Maltese: ZYDUS FRANCE 25, rue des Peupliers ZAC Les Hautes PâturesParc d'Activités des Peupliers
English: S.M.
Maltese: A.E.
English: ANGELINI PHARMA HELLAS Nea Kifissia 14564, Athens Greece
Maltese: ANGELINI PHARMA HELLAS Achaias and Troizinias, Nea Kifissia 14564, Athens Greece
English: VOCATE Pharmaceuticals S.A., Gounari 150, Glyfada 16674, Athens
Maltese: Gounari 150, Glyfada 16674, Athens Greece
English: TRB CHEMEDICA (Austria) GmbH,
Maltese: TRB Chemedica (Austria)
English: 49, avenue Georges Pompidou 92300 Levallois-Perret FRANCE
Maltese: 92300 Levallois-Perret France
English: ACTAVIS GROUP (ISLANDE) Reykjavikurvegur 76-78 220 Hafnarfjordur ISLANDE
Maltese: Reykjavikurvegur 76-78 220
English: RANBAXY PHARMACIE GENERIQUES 11-15 Quai Dion Bouton 92800 Puteaux FRANCE
Maltese: Quai de Dion Bouton 92800 Puteaux France
English: TRB Chemedica (Austria) GmbH IZ NOE
Maltese: Ir-Repubblika Slovakka TRB Chemedica (Austria) GmbH
English: Neo-Farmacêutica, S.A. Av. D. João II, Lote 1.02.2.1 D2º
Maltese: D. João II, Lote 1.02.2.1 D-2º 1990-090 Lisboa Portugal
English: List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the member states for diacerin containing medicinal products
Maltese: Lista tal-ismijiet, għamla farmaċewtika, qawwa tal-prodotti mediċinali, mnejn għandhom jingħataw, detenturi tal-awtorizzazzjoni għat-tqegħid fis suq fl-Istati Memrbi
English: NIVERPHARM 10 rue Paul Dautier 78140 Vélizy Villacoublay FRANCE
Maltese: NIVERPHARM 10 rue Paul Dautier 78140
English: 15, boulevard Charles de Gaulle 92700 C olombes
Maltese: 15, boulevard Charles de Gaulle
English: DIACEREINA PANLUETOL 50 mg cápsulas duras EFG
Maltese: DIACEREINA PANLUETOL 50 mg cápsulas duras
English: LABORATOIRES PHARMA 2000 10 rue Paul Dautier 78140 Vélizy Villacoublay FRANCE
Maltese: LABORATOIRES PHARMA 10 rue Paul Dautier 78140
English: MAZART 50 mg, gélule
Maltese: MAZART 50 mg, gélule 50 mg
English: VERBORIL 50 mg Kapseln
Maltese: VERBORIL 50 mg Kapseln 50 mg
English: DIACEREINA NORMON 50 mg cápsulas duras EFG
Maltese: DIACEREINA NORMON 50 mg cápsulas duras
English: 10, rue Paul Dautier 78140 Vélizy Villacoublay FRANCE
Maltese: 10, rue Paul Dautier 78140
English: REINART 50 mg cápsulas duras EFG
Maltese: REINART 50 mg cápsulas duras
English: 15, boulevard Charles de Gaulle 92700 Colombes FRANCE
Maltese: 92700 Colombes France
English: ZONDAR 50 mg, gélule
Maltese: ZONDAR 50 mg, gélule 50 mg
English: DIACEREIN /NORMA 50 mg capsule, hard
Maltese: DIACEREIN /NORMA 50 mg
English: SUBSTIPHARM DEVELOPPEMENT 8, rue Bellini 75116 Paris FRANCE
Maltese: DEVELOPPEMENT 24, rue Erlanger 75016 Paris FRANCE
English: G. Koronis Dilou 9, Peristeri, Attikis, 12134 Greece
Maltese: Dilou 9, Peristeri, Attikis,
English: Sued,Straße7,Obj.58D/1/2.OG 2355 Wiener Neudorf Austria
Maltese: Obj.58D/1/2.OG
English: NORMA HELLAS A.E.
Maltese: NORMA HELLAS A.E. Menandrou 54, Athens,
English: Date of latest renewal: 12 March 2009
Maltese: Data ta' tiġdid: 12 ta' Marzu 2009
English: 51063 Cologne Germany
Maltese: 51063 Cologne Ġermanja
English: Vivian Corporation Ltd. Sanitas Building, Tower Street Msida MSD 1824
Maltese: Sanitas Building, Tower Street Msida MSD 1824
English: Meda Health Sales Ireland Ltd. Office 10
Maltese: Meda Health Sales Ireland Ltd.
English: Pharmacotherapeutic Group: Benzodiazepine related drugs, ATC Code N05CF03
Maltese: Mediċini Relatati mal-Benżodjażepini, ATC Kodiċi N05CF03
English: Meda AB Pipers väg 2A S-170 09 Solna Sweden
Maltese: Meda AB Pipers väg 2 S-170 09 Solna Svezia
English: Common (≥1/100 to <1/10)
Maltese: Komuni (>1/100 sa <1/10)
English: (See section 4.5)
Maltese: (ara sezzjoni 4.7).
English: MediNet International Ltd. Narva mnt. 11D EE - 10151 Tallinn Tel: +372 62 61 025
Maltese: Narva mnt. 11D EE - 10151 Tallinn Tel: +372 62 61 025
English: INFORMATION IN BRAILLE Zerene 5 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Zerene 5 mg
English: BATCH NUMBER Lot
Maltese: NUMRU TAL LOTT Lott:
English: 7 hard capsules 10 hard capsules 14 hard capsules
Maltese: 7 kapsuli iebsin 10 kapsuli iebsin 14-il kapsula iebsin
English: Al. Jana Pawla II/15
Maltese: Jana Pawla
English: Capsule core
Maltese: U 14-IL KAPSULA
English: MediNet International Ltd. Laisvės pr. 75
Maltese: MediNet International Ltd.
English: Suomi/Finland Meda Oy
Maltese: Suomi/Finland
English: Uncommon:
Maltese: Rari:
English: Zerene has major influence on the ability to drive and use machines.
Maltese: Zerene, hemm il-possibilità li tista' ssir dipendenti fuqhom.
English: Excipients: Lactose monohydrate 49 mg.
Maltese: Kull kapsula fiha 10 mg ta' zaleplon Sustanzi mhux attivi: lactose monohydrate 49 mg.
English: Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.emea.europa.eu/.
Maltese: Aktar informazzjoni tinsab fuq il-websajt ta' L_EMEA http://www.emea.europa.eu
English: Meda Pharmaceuticals Sp.z.o.o.
Maltese: Sp.z.o.o.
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 kollaterali mhux komuni: 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 fis-sensittiva għallħsejjes (hyperacusis); disordni fix-xamm (parosmia); diskors mħawwad, inkluż diskors mhux ċar); nuqqas ta' sensazzjoni, eż. fl-estremitajiet (hypoaesthesia); taqlib ta' l-istonku; nuqqas ta' aptit; żieda fis-sensittiva għad-dawl (dawl tax-xemx, dawl UV); tħossok m'intix f'siktek (malaise).
English: Zerene belongs to a class of substances called benzodiazepine-related medicinal products, which consists of preparations with hypnotic actions.
Maltese: Zerene huwa prodott mediċinali tal-klassi benzodiazepines, li għandhom effett ipnotiku.
English: Severe renal impairment is contraindicated (see section 4.3.
Maltese: Għal insuffiċjenza renali gravi ara sezzjoni 4.3(Kontra-indikazzjonitiet).
English: Severe renal impairment
Maltese: Insuffiċjenza renali gravi
English: Excretion
Maltese: IMPOSTI
English: Ear and labyrinth disorders Uncommon:
Maltese: Taqlib fis-Sistema Immuni Rari ħafna:
English: Sweden
Maltese: Svezia
English: PHARMACEUTICAL PARTICULARS
Maltese: Meda Pharmaceuticals
English: Co-administration of Zerene together with inducers of CYP3A4 such as rifampicin, carbamazepine and phenobarbitone, may result in a reduction of zaleplon's efficacy.
Maltese: L-amministrazzjoni ta' Zerene flimkien ma prodotti li jistimulaw CYP3A4 bħal ma hu rifampicin, carbamazepine, u phenobarbitone, jistgħu jirriżultaw f'nuqqas fl-effikaċja ta' zaleplon.
English: Adverse Reactions
Maltese: Kontra-indikazzjonijiet
English: The active substance in each Zerene hard capsule is zaleplon 10 mg.
Maltese: Is-sustanza attiva ta' kull kapsula iebsa ta' Zerene hi zaleplon 10 mg.
English: • myasthenia gravis (very weak or tired muscles)
Maltese: • myasthenia gravis (muskoli dgħajfa ħafna jew għajjiena)
English: Capsule shell gelatin, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172), black iron oxide (E172), sodium lauryl sulphate, silicon dioxide.
Maltese: Il-qoxra tal-kapsula: gelatin, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172), black iron oxide (E172), sodium lauryl sulphate, silicon dioxide.
English: Special attention should be paid to respiratory or cardiovascular functions in intensive care.
Maltese: Attenzjoni speċjali għandha tingħata għallfunzjonijiet respiratorji u kardjovaskulari meta tingħata kura intensiva.
English: MEDA Pharmaceuticals AE Ευρυτανίας 3
Maltese: MEDA Pharmaceuticals AE
English: Excipient: Lactose monohydrate 54 mg.
Maltese: Kull kapsula fiha 5 mg ta' zaleplon Sustanzi mhux attivi: lactose monohydrate 54 mg.
English: amnesia, paraesthesia, somnolence ataxia/coordination abnormal, dizziness, disturbance in attention, parosmia, speech disorder (dysarthria, slurred speech), hypoaesthesia
Maltese: Mhux komuni amnesija, paraestesija, ħedla tan-ngħas, ataksja nuqqas ta' koordinazzjoni, sturdament, nuqqas ta' konċentrazzjoni, mejt, parosmija; diskors mħawwad (dysarthria, diskors mhux ċar);
English: Тел.
Maltese: Kft.
English: Capsule shell gelatin, titanium dioxide (E171), sodium lauryl sulphate, silicon dioxide.
Maltese: Il-qoxra tal-kapsula: gelatin, titanium dioxide (E171), sodium lauryl sulphate, silicon dioxide.
English: • severe kidney or liver problems
Maltese: • problemi gravi tal-kliewi u tal-fwied
English: FURTHER INFORMATION
Maltese: Informazzjoni oħra
English: Zerene 10 mg hard capsules, which contain an intensely dark blue powder, have a white cap, with pink imprint “W”, and white body, with pink imprint “10 mg”.
Maltese: Zerene, 10 mg kapsuli iebsin, li jikkonsistu minn trab blu skur qawwi, għandhom ras bajda ċara, b' intaljar “W” lewn roza fuq il-korp, u “10 mg” intaljati lewn roza.
English: Co-administration of Zerene 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' Zerene 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: • Never drink alcohol while you are being treated with Zerene.
Maltese: • Qatt tixrob alkoħol meta tkun qed tiġi ittrattat b'Zerene.
English: This can usually be avoided if you remain inactive for at least 4 hours after taking Zerene.
Maltese: Din tista' ħafna drabi tiġi evitata jekk iżżomm ruħek inattiv sa 4 sigħat wara li tieħu Zerene.
English: Zaleplon is lipophilic with a volume of distribution of about 1.4 ± 0.3 l/kg following intravenous administration.
Maltese: Zaleplon hu lipofiliku b'volum ta' distribuzzjoni ta' madwar 1.4±0.3 l/kg wara amministrazzjoni filvini.
English: Side effects that may occur commonly: drowsiness; memory difficulties; sensations like tingling, e.g. in the extremities (paraesthesia); painful menstruation.
Maltese: Effetti kollaterali l-aktar komuni: ħedla; diffikultajiet fil-memorja; sensazzjonjiiet bħal tnemnim qawwi (parasteżija)fl-estremitajiet ; uġigħ mal-menstrwazzjoni.
English: MediNet International Ltd. Ojāra Vācieša iela 13 LV-1004 Rīga Tālr: +371 67 805 140
Maltese: Ojāra Vācieša iela 13 LV-1004
English: Printing inks on the shell contain the following (pink ink SW-1105): shellac, titanium dioxide (E171), ammonium hydroxide, red iron oxide (E172), yellow iron oxide (E172).
Maltese: L-inka fuq il-qoxra fiha dawn l-ingredjenti li jmiss (pink ink SW-1105): shellac, titanium dioxide (E171), ammonium hydroxide, red iron oxide (E172), yellow iron oxide (E172).
English: Zerene did not affect the pharmacokinetic and pharmacodynamic profiles of digoxin and warfarin, two compounds with a narrow therapeutic index.
Maltese: Zerene ma teffettwax il-profili tal-farmakokinetika u tal-farmakodinamika ta' digoxin u ta' warfarin, żewġ komponenti li għandhom indiċi terapewtiċi dojoq.
English: Reproductive system and breast disorders Common:
Maltese: Disturbi fis-sistema riproduttiva u fis-sider Komuni ċiklu mqalleb ta' menstrwazzjoni
English: PVC / PVDC aluminium blister packages of 7, 10, 14 capsules in perforated unit-dose blisters.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Pakketti ta' kapsuli tal-PVC / PVDC ta' folja ta' l-aluminjum ta' 7, 10 u 14-il kapsula.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON, TEXT FOR ZERENE 10 MG - PACK SIZES 7, 10 AND 14 CAPSULES
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ IL-KARTUNA TAL-PAKKETT TA' BARRA TEST GĦAL KARTUN TA' FOLJI TA' ZERENE 10 MG KAPSULI - PAKETTI TA' 7, 10 U 14-IL KAPSULA
English: Oral administration of zaleplon to mice for 65 or 104 consecutive weeks at high dosage levels (≥100 mg/kg/day) elicited a statistically significant increase in benign but not in malignant liver tumors.
Maltese: L-amministrazzjoni mill-ħalq ta' zaleplon fil-ġrieden għal 65 jew 104 ġimgħa konsekuttiva b'dożi għoljin ta' livelli (≥100 mg/kg/jum) urew żjieda statistikament sinifikanti f'tumuri beninni, iżda mhux f'tumuri malinni tal-fwied.
English: Never drink alcohol while you are being treated with Zerene (see “Take Special care with Zerene”).
Maltese: (ara “Ħu attenzjoni speċjali b'Zerene”).
English: The active substance in each Zerene hard capsule is zaleplon 5 mg.
Maltese: Is-sustanza attiva f'kull kapsula iebsa ta' Zerene hi zaleplon 5 mg.
English: Also contains: lactose monohydrate See leaflet for further information.
Maltese: Hemm ukoll: lactose monohydrate Ara l-fuljett għal aktar informazzjoni.
English: Zerene 5 mg hard capsules zaleplon
Maltese: Kull kapsula Zerene fiha 5 mg zaleplon
English: Each pack contains 7, 10 or 14 hard capsules.
Maltese: Kull pakkett fih 7, 10 jew 14 kapsula iebsa.
English: Myasthenia gravis
Maltese: KLASSIFIKAZZJONI ĠENERALI
English: Printing inks on the shell contain the following (gold ink S-13050): shellac, lecithin, simethicone, yellow iron oxide (E172).
Maltese: L-inka fuq il-qoxra fiha dawn l-ingredjenti li jmiss (gold ink S-13050): shellac, lecithin, simethicone, yellow iron oxide (E172).
English: Uncommon (≥1/1,000 to <1/100) Rare (≥1/10,000 to <1/1,000) Very rare (<1/10,000) not known (cannot be estimated from the available data)
Maltese: Rari (taffettwa minn 1 sa 10 minn kull 10, 000 pazjent) Mhux magħruf (m'hemmx dejta biżżejjed)
English: INFORMATION IN BRAILLE Zerene 10 mg
Maltese: Zerene 10 mg
English: HOW TO TAKE ZERENE
Maltese: Tieħux Zerene:
English: Nervous system disorders Common:
Maltese: Taqlib fis-sistema nervuża Komuni
English: Zerene 5 mg hard capsules, which contain an intensely dark blue powder, have a light brown cap, with gold imprint “W”, and white body, with gold imprint “5 mg”.
Maltese: Zerene, 5 mg kapsuli iebsin, li jikkonsistu minn trab blu skur qawwi, għandhom ras kannella ċara, b' intaljar “W” lewn id-deheb fuq il-korp, u “5 mg” intaljati lewn id-deheb.
English: Zerene 10 mg hard capsules zaleplon
Maltese: Kull kapsula Zerene fiha 10mg zaleplon
English: Therefore, caution is advisable in co-administering cimetidine and Zerene.
Maltese: Għalhekk mhux rakkomandat l-użu taċ-ċimetidin u Zerene.
English: In elderly patients, sleep latency was often significantly decreased with Zerene 5 mg and was consistently decreased with Zerene 10 mg compared with placebo in 2-week studies.
Maltese: F'pazjenti anzjani, in-nuqqas ta' rqad kien imnaqqas b'mod sinjifikattiv b'doża ta' 5mg Zerene u kien imnaqqas b'mod konformi b'Zerene 10mg meta komparat mal-plaċebo fi studji ta' ġimagħtejn.
English: As clearance is reduced, patients with mild to moderate hepatic impairment should be treated with Zerene 5 mg. For severe hepatic impairment see section 4.3.
Maltese: Pazjenti bi problema epatika kemm jekk din tkun ħafifa kif ukoll jekk tkun moderata għandhom jiġu mogħtija doża ta' Zerene 5mg, għaliex ir-rata tal-eliminazzjoni f'dawn il-pazjenti hija inqas.(ara sezzjoni 4.3)
English: In patients with mild to moderate renal impairment, the pharmacokinetic profile of zaleplon is not significantly different than that in healthy subjects.
Maltese: F'pazjenti b'insuffiċjenza renali ħafif jew moderat, il-profil farmakokinetiku ta' zaleplon kien simili għal pazjenti b'saħħithom.
English: EU/1/99/099/005 10 capsules EU/1/99/099/006 14 capsules
Maltese: EU/1/99/099/005 10 kapsuli
English: EU/1/99/099/002 10 capsules EU/1/99/099/003 14 capsules
Maltese: EU/1/99/099/002 10 kapsuli
English: NAME OF THE MEDICINAL PRODUCT Zerene 10 mg hard capsules
Maltese: Zerene 10 mg kapsuli iebsin
English: Capsules have an opaque white and opaque light brown hard shell with gold band, “W” and the strength “5 mg”.
Maltese: Kapsuli li għandhom il-qoxra iebsa ta' kulur abjad opak, u kanella ċar opak, b'ċirku ta' kulur taddeheb, “W” u d-doża “5 mg”.
English: Zaleplon is a pyrazolopyrimidine hypnotic that is structurally different from benzodiazepines and other hypnotics.
Maltese: Zaleplon hu pyrażolopirimidine ipnotiku, li għandu struttura differenti minn mediċini benżodjażepini u mediċini ipnotiċi oħra.
English: If insufficient sleep duration occurs, the likelihood of impaired alertness may be increased (see section 4.5).
Maltese: Jekk ikun hemm nuqqas ta' irqad, x'aktarx li tonqos l-attenzzjoni (ara sessjoni 4.5).
English: nausea
Maltese: Ġilda
English: Psychosis
Maltese: FARMAKOLOĠIKU
English: • Reactions like restlessness, agitation, irritability, aggressiveness, abnormal thinking, delusion, rages, nightmares, depersonalisation, hallucinations, psychoses, inappropriate behaviour, extroversion that seems out of character and other behavioural effects have been reported following use of any medicines belonging to the sleep inducing group, including Zerene.
Maltese: • Nuqqas ta' sabar, aġitazzjoni, irritabilita, aggressjoni, ħsibijiet mhux tas-soltu, delużjoni, ħmar il-lejl, alluċinazzjonijiet, psikożi, mġieba mhux tas-soltu ġew innotati f'nies li uzaw mediċina tal-irqad bħal Zerene.
English: Do not use Zerene after the expiry date which is stated on the carton after EXP.
Maltese: Tużax Zerene wara d-data ta' skadenza li tidher fuq it-tikketta li hemm fuq il-kartuna.
English: SPECIAL STORAGE CONDITIONS Do not store above 30ºC.
Maltese: Taħżenx f'temperatura 'l fuq minn 30º C.
English: Elderly patients may be sensitive to the effects of hypnotics; therefore, 5 mg is the recommended dose of Zerene.
Maltese: Pazjenti anzjani jistgħu jkun sensittivi għall-effetti ta' ipnotiċi; għalhekk hu rakkomandat li d-doża ta' Zerene tkun ta' 5 mg.
English: NAME OF THE MEDICINAL PRODUCT Zerene 5 mg hard capsules
Maltese: Zerene 5 mg kapsuli iebsin
English: SK-821 02 Bratislava Tel: +421 2 4914 0172
Maltese: SK-821 02 Bratislava
English: Very common (≥1/10)
Maltese: Komuni ħafna (>1/10)
English: Zaleplon plasma concentrations increased linearly with dose, and zaleplon showed no signs of accumulation following administration of up to 30 mg/day.
Maltese: Il-konċentrazzjonijiet ta'zaleplon fil-plażma jiżdiedu linjarment mad-doża u zaleplon ma juri l-ebda sinjali ta' akkummulazzjoni wara l-amministrazzjoni sa 30 mg/jum..
English: Oral administration of zaleplon to rats for 104 consecutive weeks at dosage levels up to 20 mg/kg/day did not result in compoundrelated tumorigenicity.
Maltese: L-amministrazzjoni mill-ħalq ta'zaleplon fil-firien għal 104 ġimgħa konsekuttiva b'dożi ta' livell sa 20mg/kg/jum ma spiċċawx li jiproduċċu tumuri komplessi-relatati.
English: • hypersensitivity (an allergy) to zaleplon or to any other ingredients of Zerene
Maltese: • jekk inti allerġiku/a (tbati minn sensittività eċċessiva) għal zaleplon jew xi sustanzi oħra ta'
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 aktar serji, is-sintomi jistgħu jkunu ataxja, ipotomnija, pressjoni baxxa, depressjoni respiratorja, f'każijiet rari ta'koma u f'każijiet rari ħafna mewt.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/99/099/004 7 capsules
Maltese: TA' AWTORIZZAZZJONI GĦALL-KUMMERĊ EU/1/99/099/004 7 kapsuli
English: EU/1/99/099/004-006
Maltese: EU/1/99/099/006 14-il kapsula
English: Hepatic impairment
Maltese: Mard psikotiku
English: Medicinal product subject to medical prescription.
Maltese: TAL- PRODOTT MEDIĊINALI
English: Repeated oral administration of zaleplon to rats and dogs elicited increases in liver and adrenal weights; however, these increases occurred at high multiples of the maximum therapeutic dose, were reversible, were not associated with degenerative microscopic changes in liver or adrenal glands, and were consistent with effects in animals with other compounds that bind to benzodiazepine receptors.
Maltese: Barra dan, minħabba r-riskju li pazjenti b'dipressjoni jistgħu jieħdu intenzjonalment doża eċċessiva, ilkwantita preskritta ta' prodotti mediċinali għal dawn il-pazjenti, inkluż zaleplon, għandha tinżamm filminimu neċessarju.
English: These may consist of headaches, muscle pain, extreme anxiety, tension, restlessness, confusion and irritability.
Maltese: Dawn jistgħu jkun jikkonsistu f'uġigħ ta' ras, uġigħ tal-muskoli, anzjeta estrema, tensjoni, nuqqas ta' sabar, konfużjoni u burdati ħżiena.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/99/099/001 7 capsules
Maltese: NUMRI TA' L-AWTORIZZAZZJONI GĦALL-KUMMERĊ EU/1/99/099/001 7 kapsuli
English: Frequency not known:
Maltese: Taqlib Psikjatriku Mhux komuni:
English: Zerene's efficacy has been demonstrated in both sleep laboratory studies using objective polysomnography (PSG) measures of sleep and in outpatient studies using patient questionnaires to assess sleep.
Maltese: L-esperjenza klinika fuq l-effetti ta' doża eċċessiva ta' Zerene huma limitati, u l-livelli ta' dożi eċċessivi fil-bniedem għandhom ma ġewx determinati.
English: In addition, prior to use, surgeons intending to use Opgenra should receive a Training DVD containing animated images of an operation on a patient and including the following information: - Product description - Placement in sterile field - Wound opening (soft and hard tissues) - Reconstitution of product - Implant field preparation (haemostasis) - Administration (implantation) - Containment of implanted materials (soft tissues) - Instrumentation - Wound closure (drainage) - Follow-up measures
Maltese: - Deskrizzjoni tal-prodott - Ippostjar fiż-żona sterili - Ftuħ tal-ferita (tessuti rotob u ibsin) - Rikostituzzjoni tal-prodott - Preparazzjoni taż-żona impjantata (emostażi) - Għoti (impjantazzjoni) - Trażżin tal-materjal impjantat (tessuti rotob) - Instrumentazzjoni - Għeluq tal-ferita (dranaġġ) - Miżuri ta' wara.
English: - Information about: Hypersensitivity and antibody formation Embryo-foetotoxicity and the need for women with childbearing potential to use effective contraception for 2 years following implant
Maltese: • Tossiċità tal-fetu u l-embriju u l-bżonn għal nisa li jista' jkollhom it-tfal biex jużaw kontraċettiv effettiv għal sentejn wara l-impjant
English: The National Competent Authorities shall agree the details of an education programme for surgeons with the MAH, who must implement such programme nationally to ensure that:
Maltese: L-Awtoritajiet Kompetenti Nazzjonali ser jaqblu d-dettalji ta' programm edukattiv għall-kirurgi ma' MAH, li jridu jimplimentaw tali programm b'mod nazzjonali biex jiżguraw li:
English: Prior to use of the product, surgeons should be provided with educational material containing: - a copy of the SPC - a detailed description of:
Maltese: Qabel l-użu tal-prodott, il-kirurgi għandhom jingħataw materjal edukattiv li fih: - kopja tal-SPC - deskrizzjoni dettaljata ta':