FrancophonIA/ELRC3.0 huggingface dataset:
English: Other complex behaviours (e.g., preparing and eating food, making phone calls, or having sex) have been reported in patients who are not fully awake after taking a sedative-hypnotic.
Maltese: Imġieba kumplessa oħra (e.g., preparazzjoni u teħid ta' l-ikel, isiru telefonati, atti sesswali) ġew rapportati f'pazjenti li ma kinux kompletament imqajjmin wara li ħadu sedattiv-ipnotiku.
English: There is no pharmacokinetic interaction between zaleplon and diphenhydramine following the administration of a single dose (10 mg and 50 mg, respectively) of each drug.
Maltese: M'hemm l-ebda interazzjoni farmakokinetika bejn zaleplon u diphenhydramine wara l-għoti ta' doża waħda (10 mg u 50 mg,
English: Capsule shell gelatin, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172), black iron oxide (E172), sodium lauryl sulphate,
Maltese: Il-qoxra tal-kapsula: gelatin, titanium dioxide (E171), iron oxide aħmar (E172), iron oxide isfar (E172), iron oxide iswed (E172), sodium lauryl sulphate.
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: Għoti mill-ħalq ta' zaleplon lill-ġrieden għal 65 jew 104 ġimgħat konsekuttivi f'livelli ta' dożaġġ għoli (≥100 mg/kg/jum) wassal għal żieda statistikament sinifikanti f'tumuri beninni, iżda mhux f'tumuri malinni tal-fwied.
English: Additionally, zaleplon is metabolised by CYP3A4 to form desethylzaleplon which is further metabolised by aldehyde oxidase to form 5-oxo-desethylzaleplon.
Maltese: Barra dan zaleplon hu metabolizzat minn CYP3A4 sabiex jifforma desethylzaleplon li hu metaboliżat aktar b'aldehyde oxidase biex jifforma 5-oxo-desethylzaleplon.
English: Zaleplon is lipophilic with a volume of distribution of about 1.4 ± 0.3 l/kg following intravenous administration.
Maltese: Distribuzzjoni Zaleplon hu lipofiliku b'volum ta' distribuzzjoni ta' madwar 1.4±0.3 l/kg wara amministrazzjoni fil vini.
English: In elderly patients, sleep latency was often significantly decreased with Sonata 5 mg and was consistently decreased with Sonata 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 Sonata u kien imnaqqas b'mod konformi b'Sonata 10mg meta komparat mal-plaċebo fi studji ta' ġimagħtejn.
English: Frequency not known:
Maltese: Frekwenza mhux magħrufa:
English: Zaleplon undergoes presystemic metabolism, resulting in an absolute bioavailability of approximately
Maltese: Zaleplon jgħaddi mill-metaboliżmu presistemiku, li jirriżulta f'bijodisponibbilità assoluta ta' madwar 30%.
English: Enhancement of the central sedation may occur in cases of concomitant use with antipsychotics (neuroleptics), hypnotics, anxiolytics/sedatives, antidepressant agents, narcotic analgesics, anti-epileptic medicinal products, anaesthetics, and sedative antihistamines.
Maltese: Żjieda fis-sedazzjoni ċentrali tista' sseħħ f'każijiet ta' l-użu assoċjat ma' prodotti kontra psikosi (nurolettiċi), ipnotiċi, anzjolitiċi/sedattivi, prodotti kontra id-dipressjoni, analġesiċi narkotiċi, prodotti mediċinali kontra l-epilessija, anastetiċi,u prodotti kontra l-istamina li jraqqdu.
English: EXP
Maltese: MG
English: In addition, ibuprofen, as an example of compounds that alter renal excretion, showed no interaction with Sonata.
Maltese: Ma dan kollu, ibuprofen, bħala eżempju talkomponenti li jbiddlu l-eleminazzjoni renali, urew li m'għandhomx interazzjoni ma' Sonata.
English: EU/1/99/102/005 10 capsules EU/1/99/102/006 14 capsules
Maltese: EU/1/99/102/005 10 kapsuli
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: Linka fuq il-qoxra fiha l-ingredjenti li jmiss (linka roża SW-1105): shellac, titanium dioxide (E171), ammonium hydroxide, iron oxide aħmar (E172), iron oxide isfar (E172).
English: The active substance in each Sonata hard capsule is zaleplon 10 mg.
Maltese: Is-sustanza attiva f'kull kapsula iebsa ta' Sonata hi zaleplon 10 mg.
English: Slovenská republika MEDA Pharma spol.
Maltese: Slovenská republika MEDA Pharma spol. s r.o..
English: Sonata belongs to a class of substances called benzodiazepine-related medicinal products, which consists of preparations with hypnotic actions.
Maltese: Sonata jagħmel parti minn klassi ta' sustanzi li tissejjaħ prodotti mediċinali relatati ma' benzodiazepines, li tikkonsisti minn sustanzi li għandhom effett ipnotiku.
English: EU/1/99/102/002 10 capsules EU/1/99/102/003 14 capsules
Maltese: EU/1/99/102/002 10 kapsuli
English: There are different doses for people who are 65 or older, and those who have mild to moderate liver problems: 65 or older: Take one 5 mg capsule Mild to moderate liver problems: Take one 5 mg capsule
Maltese: 65 jew akbar: Ħu kapsula waħda ta' 5 mg Problemi tal-fwied minn ħfief sa moderati:
English: Grounds recommending the variation to the terms of the Marketing Authorisation On the basis of the scientific conclusions for zaleplon the CHMP is of the opinion that the benefit-risk balance of the medicinal product containing zaleplon is favourable subject to the proposed changes to the product information
Maltese: Abbażi ta' konklużjonijiet xjentifiċi għal zaleplon is-CHMP huwa tal-opinjoni li l-bilanċ bejn benefiċċju u riskju ta' prodotti mediċinali li fihom zaleplon huwa favorevoli soġġett għall-bidliet proposti lill-informazzjoni tal-prodott.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON, TEXT FOR SONATA 10 MG - PACK SIZES 7, 10 AND 14 CAPSULES
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ IL-KARTUNA TAL-PAKKETT TA' BARRA, TEST GĦAL SONATA 10 MG - PAKETTI TA' 7, 10 U 14-IL KAPSULA
English: Reproductive system and breast disorders Common:
Maltese: Disturbi fis-sistema riproduttiva u fis-sider Komuni:
English: Severe anaphylactic/anaphylactoid reactions have been reported with the use of sedative-hypnotics, including zaleplon.
Maltese: Reazzjonijiet anafilattiċi/anafilattojdi ġew irrapportati bl-użu ta' sedattivi-ipnotiċi, li jinkludi zaleplon.
English: The active substance in each Sonata hard capsule is zaleplon 5 mg.
Maltese: Is-sustanza attiva f'kull kapsula iebsa ta' Sonata hi zaleplon 5 mg.
English: MARKETING AUTHORISATION NUMBERS EU/1/99/102/001-003
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/99/102/001-003
English: Capsules have an opaque white and opaque light brown hard shell with the strength “5 mg”.
Maltese: Kapsuli li għandhom il-qoxra iebsa ta' kulur abjad opak, u kanella ċar opak, bid-doża “5 mg”.
English: The remainder of the urinary recovery consists of minor metabolites.
Maltese: Il-bqija ta' l-awrina miġbura ikun fiha metaboliti minuri.
English: Therefore, caution is advisable in co-administering cimetidine and Sonata.
Maltese: Għalhekk mhux rakkomandat l-użu taċ-ċimetidin u Sonata.
English: Each pack contains 7, 10 or 14 hard capsules.
Maltese: MG - PAKKETTI TA' 7, 10 U 14-IL KAPSULA
English: In patients with moderate impairment and those on dialysis there was a reduction of approximately 23% in peak plasma concentration compared to healthy volunteers.
Maltese: F'pazjenti li kellhom indeboliment moderat u dawk li kienu fuq dijalisi kien hemm riduzzjoni ta' madwar 23% fil-konċentrazzjoni tal-plażma fl-aqwa tagħha meta komparati ma' voluntiera b'saħħithom.
English: Myasthenia gravis
Maltese: Pazjenti pedjatriċi
English: photosensitivity reaction angioedema
Maltese: reazzjonijiet anafilattiċi/ta' sintomi anafilattiċi
English: NAME OF THE MEDICINAL PRODUCT Sonata 10 mg hard capsules
Maltese: Sonata 10 mg kapsuli iebsin
English: Sonata 5 mg hard capsules zaleplon
Maltese: Kull kapsula Sonata fiha 5 mg zaleplon
English: Caution should be observed when prescribing sedative medicinal products to patients with chronic respiratory insufficiency.
Maltese: Wieħed għandu joqgħod attent meta jippreskribi prodotti sedattivi lill-pazjenti li għandhom insuffiċjenza respiratorja kronika.
English: Pharmacotherapeutic Group: Benzodiazepine related drugs, ATC Code N05CF03
Maltese: Mediċini Relatati mal-Benżodjażepini, Kodiċi ATC N05CF03 Zaleplon hu pyrażolopirimidine ipnotiku, li għandu struttura differenti minn mediċini benżodjażepini u mediċini ipnotiċi oħra.
English: Psychosis
Maltese: FARMAĊEWTIKU
English: Elderly
Maltese: Dardir
English: Due to zaleplon's short plasma half-life, alternative therapy should be considered if early morning awakening is experienced.
Maltese: Minħabba li zaleplon jonqos bin-nofs f'qasir żmien fil-plażma (short plasma half-life), terapija alternattiva għandha tkun ikkunsidrata jekk il-pazjent iqum kmieni fil-għodu.
English: MEDA Pharma GmbH & Co. KG Benzstraße 1
Maltese: KG Benzstraße 1
English: • if you have severe kidney or liver problems.
Maltese: • jekk għandek problemi severi fit-teħid tan-nifs jew problemi tas-sider.
English: Consequently, the oral clearance of zaleplon was reduced by 70% and 87% in compensated and decompensated cirrhotic patients, respectively, leading to marked increases in mean Cmax and AUC (up to 4-fold and 7-fold in compensated and decompensated patients, respectively) relative to healthy subjects.
Maltese: Dan wassal għal żjiedet ras għar-ras fil-Cmax u AUC (sa 4 darbiet u sa 7 darbiet f'pazjenti kompensati u mhux kompensati, rispettivament) meta mqabbla ma' pażjenti b'saħħithom.
English: Do not take Sonata
Maltese: Tiħux Sonata:
English: These medicines include: substances used in the treatment of mental conditions (antipsychotics, hypnotics, anxiolytics/sedatives, antidepressants), medicines used for strong pain relief (narcotic analgesics), medicines used for the treatment of seizures/convulsions (antiepileptic medicines), medicines used for loss of feeling/insensibility (anaesthetics), and medicines used in the treatment of allergies (sedative antihistamines).
Maltese: Dawn il-mediċini jinkludu: sustanzi li jintużaw biex jittrattaw kundizzjonijiet mentali (anti-psikotiċi, ipnotiċi, anksjolitiċi/sedattivi, mediċini kontra d-dipressjoni), mediċini qawwija użati għal soliev ta' l-uġigħ (analġesiċi narkotiċi) mediċini użati għat-trattament ta' puplesiji/aċċessjonijiet (mediċini ta' kontra l-epilessija), anesteteiċi, u mediċini użati biex jittrattaw l-allerġiji (mediċini sedattivi kontra l-ħistamini).
English: Oral administration of zaleplon to rats for 104 consecutive weeks at dosage levels up to 20 mg/kg/day did not result in compound-related tumorigenicity.
Maltese: Għoti mill-ħalq ta' zaleplon lill-firien għal 104 ġimgħat konsekuttivi f'livelli ta' dożaġġ sa 20 mg/kg/jum ma wassalx għal tumuri relatati mas-sustanza.
English: Capsules have an opaque white hard shell with the strength “10 mg”.
Maltese: Kapsuli li għandhom il-qoxra iebsa ta' kulur abjad opak bid-doża “10 mg”.
English: In line with effects observed with other compounds binding to benzodiazepine receptors, reversible increases in liver and adrenal weights in rats and dogs were only noted upon repeated oral administration of high multiples of the maximum human therapeutic dose.
Maltese: F'konformità mal-effetti osservati b'sustanzi oħra li jeħlu ma' riċetturi ta' benzodiazepine, żidiet riversibbli fil-piż tal-fwied u l-adrenali fil-firien u l-klieb kienu osservati biss wara għoti orali ripetut ta' multipli għoljin tad-doża terapewtika massima tal-bniedem.
English: • if you have myasthenia gravis (very weak or tired muscles).
Maltese: • jekk għandek myasthenia gravis (muskoli dgħajfa ħafna jew għajjiena).
English: Chaussée de la Hulpe 166/ Terhulpsesteenweg 166 B-1170 Brussels Tél/Tel: +32 2 5 04 08 11
Maltese: België/Belgique/Belgien MEDA Pharma S.A./N.V. Chaussée de la Hulpe 166/ Terhulpsesteenweg 166 B-1170 Brussels Tél/Tel:
English: As clearance is reduced, patients with mild to moderate hepatic impairment should be treated with Sonata 5 mg. For severe hepatic impairment see section 4.3.
Maltese: Insuffiċjenza tal-fwied Pazjenti bi problema epatika kemm jekk din tkun ħafifa kif ukoll jekk tkun moderata għandhom jiġu mogħtija doża ta' Sonata 5mg, għaliex ir-rata tal-eliminazzjoni f'dawn il-pazjenti hija inqas.(ara sezzjoni 4.3)
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 Sonata.
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 Sonata.
English: Children and adolescents Do not give this medicine to children and adolescents under 18 years of age.
Maltese: Tfal u adolexxenti Tagħtix din il-mediċina lil tfal u adolexxenti b'età ta' inqas minn 18-il sena.
English: Sonata'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' Sonata huma limitati, u l-livelli ta' dożi eċċessivi fil-bniedem għandhom ma ġewx determinati.
English: Ingredients of the capsule shell: gelatin, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172), black iron oxide (E172) and sodium lauryl sulphate.
Maltese: Is-sustanzi li jinsabu fil-qoxra tal-kapsula huma: titanium dioxide (E171), iron oxide aħmar (E172), iron oxide isfar (E172), iron oxide iswed (E172) u sodium lauryl sulphate.
English: Sonata 10 mg hard capsules zaleplon
Maltese: Kull kapsula Sonata fiha 10mg zaleplon
English: • There is a chance that you may experience a certain type of temporary memory loss (amnesia) and lack of coordination when taking sleep medicines.
Maltese: • Hemm iċ-ċans li tista' jkollok esperjenza temporanja ta' ċerta tip ta' telf ta' memorja (amnesija) u nuqqas ta' ko-ordinazzjoni meta tieħu mediċina tal-irqad.
English: Benzodiazepine and benzodiazepine-like agents are not recommended for the primary treatment of psychotic illness.
Maltese: L-użu tal-benżodjażepin u prodotti simili għall-benżodjażepin m'humiex rakkomandati bħala trattament primarju għall-mard psikotiku.
English: Concomitant use of zaleplon with these drugs may increase the risk of next day drowsiness, including impaired driving ability (see section 4.7).
Maltese: Użu ta' zaleplon flimkien ma' dawn il-mediċini jista' jżid irriskju ta' ngħas fil-jum ta' wara, inkluż indeboliment fil-ħila li ssuq (ara sezzjoni 4.7).
English: Very common (1/10)
Maltese: Rari ħafna (<1/10,000)
English: Periodic Safety Update Reports
Maltese: Informazzjoni għall-utent
English: Use of benzodiazepines and benzodiazepine-like agents may lead to physical and psychic dependence.
Maltese: L-użu ta' benżodjażepin u ta' prodotti oħra simili għall-benżodjażepin jista' jwassal għal dipendenza fiżika u psikika.
English: NAME OF THE MEDICINAL PRODUCT Sonata 5 mg hard capsules
Maltese: Sonata 5 mg kapsuli iebsin
English: Ear and labyrinth disorders Uncommon:
Maltese: Disturbi fil-widnejn u fis-sistema labirintika Mhux komuni:
English: Symptoms of overdose
Maltese: Sintomi ta' doża eċċessiva
English: Meda Pharmaceuticals Sp. z o.o.
Maltese: Sp. z o.o.
English: Reactions like restlessness, agitation, irritability, decreased inhibition, aggressiveness, abnormal thinking, delusion, rages, nightmares, depersonalisation, hallucinations, psychoses, inappropriate behaviour, extroversion that seems out of character and other behavioural effects are known to occur when using benzodiazepines or benzodiazepine-like agents.
Maltese: Reazzjonijiet bħal nuqqas ta' sabar, aġitazzjoni, burdati ħżiena, nuqqas ta' mistħija, aggressivita, ħsibijet abnormali, delużjonijiet, rabja, ħmir il-lejl, nuqqas ta' personalità, alluċinazzjonijiet, psikosi, mġiba mhux flokha, estrovertiżmu li hu barra mill-karattru, u effetti ta' imġiba avversa huma magħrufa li ġraw meta intuża benżodjażepin u prodotti simili għall-benżodjażepin.
English: • if you are allergic to zaleplon or any of the other ingredients of this medicine (listed in section 6).
Maltese: • jekk inti allerġiku għal zaleplon jew għal xi sustanza oħra ta' din il-mediċina (elenkati fis sezzjoni 6).
English: Furthermore, the co-administration of zaleplon with alcohol and other CNS depressants increases this risk (see section 4.5).
Maltese: Barra dan, l-għoti ta' zaleplon flimkien ma' alkoħol u depressanti oħra tas-CNS iżid dan ir-riskju (ara sessjoni 4.5).
English: Polska
Maltese: България
English: Zaleplon binds selectively to the benzodiazepine type I receptor.
Maltese: Zaleplon jaqbad selettivament ma' reċetturi tal-benżodjażepini tat-tip I.
English: The no-effect dose for postnatal development was 1 mg/kg/day (equivalent to 0.5-times the MRHD on a mg/m2 basis).
Maltese: Id-doża tal-ebda effett fuq l-iżvilupp wara ttwelid kienet ta' 1 mg/kg/jum (ekwivalenti għal 0.5 darbiet l-MRHD fuq bażi ta' mg/m2).
English: Nervous system disorders Common:
Maltese: Disturbi fis-sistema nervuża
English: Depression Pre-existing depression may be unmasked during benzodiazepine or benzodiazepine-like agent use.
Maltese: Ġew rappurtati abbużi minn benżodjażepin u mediċini simili għall-benżodjażepin.
English: Printing inks on the shell contain the following (gold ink SB-3002): shellac, ammonium hydroxide, yellow iron oxide (E172).
Maltese: Linka tal-istampar fuq ilqoxra tal-kapsula tikkonsisti minn dan li ġej (linka lewn id-deheb S-13050): shellac, ammonium hydroxide, iron oxide isfar (E172).
English: Children and adolescents (under 18 years of age)
Maltese: Tfal u adolexxenti (taħt 18-il sena)
English: Ingredients of the capsule shell: gelatin, titanium dioxide (E171) and sodium lauryl sulphate.
Maltese: Is-sustanzi li jinsabu fil-qoxra tal-kapsula huma: titanium dioxide (E171) u sodium lauryl sulphate.
English: The no-effect dose for growth of rat offspring was 10 mg/kg (equivalent to 5-times the MRHD on a mg/m2 basis).
Maltese: Id-doża tal-ebda effett fuq it-tkabbir tal-frieħ tal-firien kienet ta' 10 mg/kg (ekwivalenti għal 5 darbiet l-MRHD fuq bażi ta' mg/m2).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/99/102/004 7 capsules
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/99/102/004 7 kapsuli
English: amnesia, paraesthesia, somnolence ataxia/coordination abnormal, dizziness, disturbance in attention, parosmia, speech disorder (dysarthria, slurred speech), hypoaesthesia
Maltese: nuqqas ta' konċentrazzjoni, mejt, parosmija; diskors mħawwad (dysarthria, diskors mhux ċar);
English: nausea
Maltese: sonnambuliżmu
English: Rebound insomnia and anxiety
Maltese: Disturbi Gastro-intestinali
English: PHARMACEUTICAL FORM AND CONTENTS 7 hard capsules
Maltese: 7 kapsuli iebsin 10 kapsuli iebsin 14-il kapsula iebsin
English: SK-821 02 Bratislava Tel: +421 2 4914 0171
Maltese: SK-821 02 Bratislava
English: NAME OF THE MARKETING AUTHORISATION HOLDER Meda AB
Maltese: FIS-SUQ Meda AB
English: Meda Pharma SIA Veiverių 134
Maltese: MEDA PHARMA SAS 25
English: A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Maltese: MANIFATTUR(I) RESPONSABBLI
English: Sonata may make you feel drowsy, cause loss of concentration or memory or muscle weakness.
Maltese: Sewqan u tħaddim ta' magni Sonata jista' jħeddlek, jikkawza nuqqas ta' konċentrazzjoni jew telf ta'memorja jew indeboliment fil muskoli.
English: Memory and psychomotor impairment
Maltese: Reazzjonijiet psikjatri u paradossali
English: • Never drink alcohol while you are being treated with Sonata.
Maltese: • Qatt tixrob alkoħol meta tkun qed tiġi ittrattat b'Sonata.
English: Diphenhydramine is reported to be a weak inhibitor of aldehyde oxidase in rat liver, but its inhibitory effects in human liver are not known.
Maltese: Studji ta' segwitu indikaw li fertilità indebolita kienet ikkawżata mill-effett fuq innisa.
English: Sonata did not affect the pharmacokinetic and pharmacodynamic profiles of digoxin and warfarin, two compounds with a narrow therapeutic index.
Maltese: Sonata ma teffettwax il-profili tal-farmakokinetika u tal-farmakodinamika ta' digoxin u ta' warfarin,
English: Meda Pharma SIA Vienības gatve 109 LV-1058 Riga, Latvia Tel.: +371 67616137
Maltese: LV-1058 Riga, Latvia Tel.:
English: How to store Sonata
Maltese: X'fih Sonata
English: MARKETING AUTHORISATION NUMBER(S) EU/1/99/102/001 7 capsules
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/99/102/001 7 kapsuli
English: Warnings already exist in the zaleplon product information however based on the available information the PRAC considered it prudent within this procedure to strengthen the wording in SmPC and PL to ensure clear information is available for patients and healthcare professionals given the potentially serious consequences of next day psychomotor impairment.
Maltese: Jekk ilprodott mediċinali jiġi preskritt lil mara li jista' jkollha t-tfal, hi għandha tkun imwissiha biex tgħid littabib rigward it-twaqqif tal-prodott mediċinali, jekk ikollha l-ħsieb li toħroġ tqila jew tissuspetta li hi tqila.
English: Further, stabilization of circulatory function and intensive monitoring may be required.
Maltese: Barra dan, jista' jkun meħtieġ stabbilizzazzjoni tal-funzjoni ċirkolatorja u monitoraġġ intensiv.
English: ELPEN SA PHARMACEUTICAL INDUSTRY
Maltese: ELPEN SA PHARMACEUTICAL
English: Office in Warsaw: ul.
Maltese: Office in Warsaw:
English: capsule, hard
Maltese: kapsula, iebsa
English: FARAN ABEE PRODUCTION AND DISTRIBUTION OF MEDICINES ACHAIAS AND TRIZOINIAS NEA KIFISSIA
Maltese: FARAN ABEE PRODUCTION AND DISTRIBUTION OF MEDICINES ACHAIAS AND TRIZOINIAS NEA
English: A. NIKOLAKOPOULOS AND CO GALATSIOU AVENUE 115, ATHENS 11146
Maltese: NIKOLAKOPOULOS AND CO GALATSIOU AVENUE 115, ATHENS 11146
English: 25, rue des Peupliers ZAC Les Hautes Pâtures - Parc d'Activités des Peupliers 92000 NANTERRE France
Maltese: 25, rue des Peupliers ZAC Les Hautes Pâtures - Parc d'Activités des Peupliers 92000
English: - Strada Solaro n. 75-77 - Villa Sayonara - Sanremo - 18038 IMPERIA
Maltese: LABORATORIO FARMACEUTICO C.T. S.r.l. - Strada Solaro n. 75-77 - Villa Sayonara - Sanremo - 18038 IMPERIA
English: 18TH KM MARATHONOS AVENUE PALLINI
Maltese: KM MARATHONOS AVENUE PALLINI
English: ANFARM HELLAS PERIKLEOUS 53-57 ATHENS 105 60 Greece
Maltese: HELLAS PERIKLEOUS 53-57 ATHENS 105 60
English: LABORATOIRE RATIOPHARM 19, boulevard Paul Vaillant Couturier 94200 IVRY SUR SEINE France
Maltese: LABORATOIRE RATIOPHARM 19, boulevard Paul Vaillant Couturier 94200
English: Invented name Strength
Maltese: Isem inventat
English: Ikelan solution for injection or infusion 50mg/5ml injection
Maltese: Ikelan solution for injection or infusion 50mg/5ml injezzjoni
English: MYLAN SAS 117, allée des Parcs 69800 SAINT-PRIEST France
Maltese: SAS 117, allée des Parcs 69800 SAINT-PRIEST France
English: LOFTON 150 mg/ml gotas orales en solución oral drops solution
Maltese: LOFTON 150 mg/ml gotas orales en solución soluzzjoni ta' qtar orali
English: oral drop, solution
Maltese: qtar orali, soluzzjoni
English: Spain
Maltese: Spanje
English: CEPHALON FRANCE 20, rue Charles Martigny 94700 MAISONS-ALFORT FRANCE
Maltese: CEPHALON FRANCE 20, rue Charles Martigny 94700
English: NORMA HELLAS S.A. MENANDROU 54 ATHENS 10432
Maltese: NORMA HELLAS S.A. MENANDROU 54
English: Buflomedil-CT 50mg/5ml Ampullen
Maltese: Buflomedil-CT 50mg/5ml Ampullen 50mg / 5ml
English: LOFTON 150 mg comprimidos recubiertos coated tablet
Maltese: LOFTON 150 mg comprimidos recubiertos pillola miksija
English: LOFTYL 50 mg/5 ml, solution injectable
Maltese: LOFTYL 50 mg/5 ml, solution injectable 50 mg/5 ml
English: BIOMEDICA FOSCAMA GROUP SpA Via della Giuliana 73 00195 Roma
Maltese: Via della Giuliana 73 00195 Roma
English: AbZ-Pharma GmbH Dr.Georg-Spohn-Str. 7 D-89143 Blaubeuren Germany
Maltese: AbZ-Pharma GmbH Dr.Georg-Spohn-Str.
English: oral solution
Maltese: soluzzjoni orali
English: tablets
Maltese: pilloli
English: Actavis Deutschland GmbH & Co. KG Elisabeth-Selbert-Str. 1
Maltese: KG Elisabeth-Selbert-Str.
English: AMDIPHARM LIMITED 3, TEMPLE CHAMBERS IRL DUBLIN
Maltese: LIMITED 3, TEMPLE CHAMBERS IRL DUBLIN