FrancophonIA/ELRC3.0 huggingface dataset:
English: Based on the review of the data at the time of the withdrawal, the CHMP had concerns and was of the provisional opinion that DepoCyte could not be approved for the intrathecal treatment of solid tumour neoplastic meningitis.
Dutch: Op basis van de bestudering van de informatie had het CHMP op het ogenblik van de intrekking twijfels en was het de voorlopige mening toegedaan dat DepoCyte niet kon worden goedgekeurd voor de intrathecale behandeling van neoplastische meningitis van solide tumoren.
English: DepoCyte is injected directly into the nervous system, in the space between the lining of the spinal cord and brain (intrathecal injection).
Dutch: DepoCyte wordt rechtstreeks in het zenuwstelsel geïnjecteerd, binnen de hersen- en ruggenmergsvliezen (intrathecale injectie).
English: DepoCyte was to be used in the treatment of solid tumour neoplastic meningitis: this is a disease where cancer cells, originally from a solid tumour (such as lung or breast cancer), spread to the membranes of the nervous system.
Dutch: DepoCyte zou worden toegepast bij de behandeling van neoplastische meningitis van solide tumoren: dit is een aandoening waarbij kankercellen, afkomstig van een solide tumor (zoals long- of borstkanker), uitzaaien naar de hersen- en ruggenmergsvliezen.
English: DepoCyte is used to treat lymphomatous meningitis: this is a condition where lymphoma tumour cells have spread to the membranes that surround the nervous system (meninges).
Dutch: DepoCyte wordt gebruikt voor de behandeling van lymfomateuze meningitis: dit is een aandoening waarbij lymfoomtumorcellen zijn uitgezaaid naar de vliezen die het centrale zenuwstelsel (hersenen en ruggenmerg) omgeven (meningen).
English: What was DepoCyte expected to be used for?
Dutch: Voor welke behandeling was DepoCyte bedoeld?
English: Outcome of a procedure under Article 29(4) of Directive 2001/83/EC
Dutch: Resultaten van een procedure krachtens artikel 29, lid 4 van Richtlijn 2001/83/EG
English: 06 August 2014
Dutch: 6 augustus 2014
English: The European Commission issued a decision on 06 August 2014.
Dutch: Het besluit van de Europese Commissie werd op 6 augustus 2014 gepubliceerd.
English: What is Dexamed?
Dutch: Wat is Dexamed?
English: Why was Dexamed reviewed?
Dutch: Waarom werd Dexamed beoordeeld?
English: On 22 May 2014, the European Medicines Agency completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Dexamed (dexamfetamine sulphate).
Dutch: Het Europees Geneesmiddelenbureau heeft op 22 mei 2014 een arbitrageprocedure afgerond naar aanleiding van een verschil in inzicht tussen lidstaten van de Europese Unie (EU) met betrekking tot de goedkeuring van het geneesmiddel Dexamed (dexamfetaminesulfaat).
English: EMA/709170/2013 Rev.1 EMEA/H/A-29/1375
Dutch: EMA/709170/2013 Herz.1 EMEA/H/A-29/1375
English: These conclusions were supported by a group of experts in childhood and adolescent behavioural problems consulted by the CHMP.
Dutch: Deze conclusies werden ondersteund door een groep van deskundigen in gedragsproblemen van kinderen en jongeren die door het CHMP werd geraadpleegd.
English: However, the Member States were not able to reach an agreement and the UK medicines regulatory agency referred the matter to the CHMP for arbitration on 10 June 2013.
Dutch: De lidstaten wisten echter geen overeenstemming te bereiken en de regelgevende instantie voor geneesmiddelen in het Verenigd Koninkrijk verwees de zaak op 10 juni 203 voor arbitrage naar het CHMP.
English: Kohne Pharma GmbH submitted Dexamed to the UK medicines regulatory agency for a decentralised procedure.
Dutch: Kohne Pharma GmbH heeft Dexamed bij de regelgevende instantie voor geneesmiddelen in het Verenigd Koninkrijk ingediend voor een gedecentraliseerde procedure.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of Dexamed outweigh its risks, and the marketing authorisation can be granted in the United Kingdom and in the following countries: Denmark, Finland, Ireland, Luxembourg, the Netherlands, Norway, Spain and Sweden.
Dutch: Het Comité voor geneesmiddelen voor menselijk gebruik (CHMP) van het Geneesmiddelenbureau heeft geconcludeerd dat de voordelen van Dexamed groter zijn dan de risico's, en dat de vergunning voor het in de handel brengen kan worden verleend in het Verenigd Koninkrijk en in de volgende landen: Denemarken, Finland, Ierland, Luxemburg, Nederland, Noorwegen, Spanje en Zweden.
English: Dexamed is a medicine that contains the active substance dexamfetamine sulphate.
Dutch: Dexamed is een geneesmiddel dat de werkzame stof dexamfetaminesulfaat bevat.
English: Educational material will also be given to pharmacists, parents and carers to help them identify any potential abuse or improper use of Dexamed.
Dutch: Er zal ook voorlichtingsmateriaal worden verstrekt aan apothekers, ouders en verzorgers om hen te helpen eventueel mogelijk misbruik of onjuist gebruik van Dexamed vast te stellen.
English: It is to be available as tablets (5 mg) for the treatment of children between 6 and 17 years of age who have attention deficit hyperactivity disorder (ADHD) and in whom methylphenidate (another medicine for ADHD) was not effective (second-line treatment).
Dutch: Het zal verkrijgbaar zijn als tabletten (5 mg) voor de behandeling van kinderen tussen 6 en 17 jaar oud die ADHD (attention deficit hyperactivity disorder, aandachtstekortstoornis met hyperactiviteit) hebben en bij wie methylfenidaat (een ander geneesmiddel voor ADHD) niet werkzaam was (tweedelijnsbehandeling).
English: These measures include starting and regularly monitoring treatment with Dexamed under the supervision of a doctor experienced in treating childhood and adolescent behaviour disorders.
Dutch: Deze maatregelen omvatten het starten en regelmatig controleren van behandeling met Dexamed onder toezicht van een arts die ervaring heeft met het behandelen van gedragsproblemen van kinderen en jongeren.
English: Furthermore, the company that markets Dexamed will conduct additional studies on the risk of abuse for this medicine.
Dutch: Verder zal het bedrijf dat Dexamed op de markt brengt aanvullende onderzoeken uitvoeren naar het risico op misbruik van dit geneesmiddel.
English: Educational material will be provided to doctors to help them decide if treatment with Dexamed is appropriate and to monitor patients receiving the medicine.
Dutch: Er zal aan artsen voorlichtingsmateriaal worden verstrekt om hen te helpen beslissen of behandeling met Dexamed passend is en om patiënten die het geneesmiddel krijgen te controleren.
English: The CHMP also noted that evidence from studies and clinical practice is available to show that dexamfetamine is effective in ADHD, including in patients in whom other treatments have failed.
Dutch: Het CHMP merkte ook op dat er bewijs uit onderzoeken en de klinische praktijk beschikbaar is waaruit blijkt dat dexamfetamine werkzaam is bij ADHD, inclusief bij patiënten bij wie andere behandelingen hebben gefaald.
English: ADHD is a condition that mainly affects children, resulting in a persistent inability to concentrate, hyperactivity and impulsive behaviour.
Dutch: ADHD is een aandoening die voornamelijk voorkomt bij kinderen en die resulteert in aanhoudende concentratieproblemen, overactiviteit en impulsief gedrag.
English: The grounds for the referral were concerns raised by the Netherlands that Dexamed presents a higher risk for abuse and dependence compared with other ADHD treatments, and that the data submitted to support the application did not provide sufficient evidence to demonstrate its effectiveness as a second-line treatment for ADHD.
Dutch: De redenen voor de verwijzing waren de bedenkingen van Nederland dat Dexamed een hoger risico op misbruik en verslaving met zich meebrengt dan andere ADHD-behandelingen, en dat de verstrekte gegevens om de aanvraag te ondersteunen onvoldoende bewijs leverden om de werkzaamheid ervan als tweedelijnsbehandeling voor ADHD aan te tonen.
English: Although the CHMP acknowledged that there is a risk of abuse and dependence with Dexamed, it concluded that the risk minimisation measures proposed to mitigate this risk are adequate.
Dutch: Hoewel het CHMP erkende dat er bij Dexamed een risico op misbruik en verslaving bestaat, concludeerde het Comité dat de voorgestelde risicobeperkende maatregelen voldoende zijn om dit risico te beperken.
English: Therefore, based on evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the benefits of Dexamed outweigh its risks for second-line treatment of ADHD and recommended that the marketing authorisation be granted in all concerned Member States.
Dutch: Op grond van de beoordeling van de op dat moment beschikbare gegevens en de wetenschappelijke discussie binnen het CHMP concludeerde het CHMP derhalve dat de voordelen van Dexamed als tweedelijnsbehandeling voor ADHD groter zijn dan de risico's, en heeft het geadviseerd een vergunning te verlenen voor het in de handel brengen van dit middel in alle betrokken lidstaten.
English: The experts' group advised that while there is some evidence that medicines of the same type as Dexamed are more likely to induce dependence than other treatments for ADHD, based on clinical practice the risk of developing dependence in patients treated with dexamfetamine is considered to be low and could be adequately managed with appropriate risk minimisation measures.
Dutch: De groep van deskundigen adviseerde dat, hoewel er enige aanwijzingen zijn dat geneesmiddelen van hetzelfde type als Dexamed eerder verslaving teweeg zullen brengen dan andere behandelingen voor ADHD, het risico op het ontwikkelen van verslaving bij met dexamfetamine behandelde patiënten op basis van de klinische praktijk laag wordt geacht en adequaat kan worden beheerst met passende risicobeperkende maatregelen.
English: This is a procedure where one European country (the ‘reference Member State', in this instance the United Kingdom) assesses a medicine with a view to granting a marketing authorisation that will be valid in this country as well as in other European countries (the ‘concerned Member States', in this instance Denmark, Finland, Ireland, Luxembourg, the Netherlands, Norway, Spain, and Sweden).
Dutch: Europese landen (de ‘betrokken lidstaten', in dit geval Denemarken, Finland, Ierland, Luxemburg, Nederland, Noorwegen, Spanje en Zweden) geldig zal zijn.
English: Dexamfetamine belongs to a group of medicines called ‘psychostimulants' and is thought to work by activating certain areas of the brain that control attention and concentration, thus helping to reduce impulsive behaviour.
Dutch: De werking ervan zou berusten op het activeren van gebieden in de hersenen die de aandacht en concentratie reguleren en zo helpen om impulsief gedrag te verminderen.
English: MA (EU) Number (Invented) name Strength
Dutch: (Fantasie)naam Sterkte Farmaceutische Vorm Toedienings-weg Primaire Verpakking
English: Pack size
Dutch: EU -Nummer
English: 6.2 Incompatibilities
Dutch: 6.2 Inkompatibilitajiet
English: Week 1, 2, 3, 4 Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28
Dutch: Jum 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28
English: tmax is between 3 and 8 hours.
Dutch: tmax hija bejn 3 u 8 sigħat.
English: Adults
Dutch: Adulti
English: UNIQUE IDENTIFIER - 2D BARCODE
Dutch: IDENTIFIKATUR UNIKU - BARCODE 2D
English: See section 4.
Dutch: Ara sezzjoni 4.
English: 4.3 Contraindications
Dutch: 4.3 Kontra-indikazzjonijiet
English: SYSTEM ORGAN CLASS
Dutch: SISTEMA TAL-KLASSIFIKA TALORGANI
English: 4 years.
Dutch: 4 snin.
English: Summary of the safety profile
Dutch: Sommarju tal-profil tas-sigurtà
English: Possible side effects
Dutch: Effetti sekondarji possibbli
English: Oral solution.
Dutch: Soluzzjoni orali.
English: Distribution
Dutch: Distribuzzjoni
English: Pharmacotherapeutic group: Other Anti-dementia drugs, ATC code: N06DX01.
Dutch: Kategorija farmakoterapewtika: Mediċini oħra ta' kontra d-dimenzja, Kodiċi ATC: N06DX01.
English: INSTRUCTIONS ON USE 16.
Dutch: STRUZZJONIJIET DWAR L-UŻU 16.
English: Tablet coating Hypromellose Macrogol 400
Dutch: Hypromellose Macrogol 400
English: Lot {number}
Dutch: Lott {numru}
English: 2D barcode carrying the unique identifier included.
Dutch: barcode 2D li jkollu l-identifikatur uniku inkluż.
English: INFORMATION IN BRAILLE
Dutch: INFORMAZZJONI BIL-BRAILLE
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients
Dutch: 6.1 Lista ta' eċċipjenti
English: Symptoms
Dutch: Sintomi
English: No data are available.
Dutch: M'hemm l-ebda data disponibbli.
English: Excipients: Each one millilitre of solution contains 100 mg sorbitol (E 420) and 0.5 mg potassium, see section 4.4.
Dutch: Sustanzi mhux attivi: Kull millilitru ta' soluzzjoni fiha 100 mg sorbitol (E 420) u 0.5 mg potassju, ara sezzjoni 4.4.
English: EU/1/02/218/011 500 ml (10 bottles of 50 ml)
Dutch: EU/1/02/218/011 500 ml (10 x 50 ml)
English: Oral solution 50 ml
Dutch: Soluzzjoni orali 50 ml
English: Renal impairment
Dutch: Indeboliment renali
English: Memantine has an absolute bioavailability of approximately 100%.
Dutch: Memantine għandu bijodisponibilità assoluta ta' madwar 100%.
English: 4.6 Fertility, pregnancy and lactation
Dutch: 4.6 Fertilità, tqala u Treddigħ
English: Reporting of side effects
Dutch: Rappurtar tal-effetti sekondarji
English: The most frequently occurring adverse reactions with a higher incidence in the Axura group than in the placebo group were dizziness (6.3% vs 5.6%, respectively), headache (5.2% vs 3.9%), constipation (4.6% vs 2.6%), somnolence (3.4% vs 2.2%) and hypertension (4.1% vs 2.8%).
Dutch: L-aktar reazzjonijiet avversi li seħħew ta' spiss fil-grupp ta' Axura milli fil-grupp tal-plaċebo kienu sturdament (6.3% vs 5.6%, rispettivament), uġigħ ta' ras (5.2% vs 3.9%), stitikezza (4.6% vs 2.6%), ngħas (3.4% vs 2.2%) u pressjoni għolja (4.1% vs 2.8%).
English: Memantine did not inhibit CYP 1A2, 2A6, 2C9, 2D6, 2E1, 3A, flavin containing monooxygenase, epoxide hydrolase or sulphation in vitro.
Dutch: Memantine m'għamilx impediment fuq CYP 1A2, 2A6, 2C9, 2D6, 2E1, 3A, monoxygenase li fih flavin, epoxide hydrolase jew sulfejxin in vitro.
English: Memantine is eliminated in a monoexponential manner with a terminal t½ of 60 to 100 hours.
Dutch: Memantine jitneħħa b'mod mono-esponenzjali b' t½ terminali ta' 60 sa 100 siegħa.
English: • Risk Management Plan (RMP)
Dutch: • Pjan tal-ġestjoni tar-riskju (RMP)
English: Clinical studies
Dutch: Studji kliniċi
English: Mon → Tue → Wed → Thu → Fri → Sat → Sun
Dutch: X'għandek tkun taf qabel ma tieħu Axura
English: Very rare
Dutch: Rari ħafna
English: Immune systeme disorders
Dutch: Disturbi fis-sistema immuni
English: Maintenance dose
Dutch: Doża ta' manteniment
English: About 45% of memantine is bound to plasma-proteins.
Dutch: Madwar 45% ta' memantine jeħel mal-proteini tal-plażma.
English: 4.5 Interaction with other medicinal products and other forms of interaction
Dutch: 4.5 Interazzjoni ma' prodotti mediċinali oħra u forom oħra ta' interazzjoni
English: LIST OF EXCIPIENTS
Dutch: LISTA TA' EĊĊIPJENTI
English: Date of first authorisation: 17 May 2002 Date of latest renewal: 17 May 2007
Dutch: Data ta' l-ewwel awtorizzazzjoni: 17 mejju 2002 Data ta' l-aħħar tiġdid: 17 mejju 2007
English: Cardiac failure
Dutch: Insuffiċjenza kardijaka
English: Nervous system disorders
Dutch: Disturbi fis-sistema nervuża
English: Linearity
Dutch: Linjarità
English: Tabulated list of adverse reactions
Dutch: Lista tabulata ta' reazzjonijiet avversi
English: Absorption
Dutch: Assorbiment
English: Gastrointestinal disorders
Dutch: Disturbi gastro-intestinali
English: QUALITATIVE AND QUANTITATIVE COMPOSITION
Dutch: GĦAMLA KWALITATTIVA U KWANTITATTIVA
English: Main human metabolites are N-3,5-dimethyl-gludantan, the isomeric mixture of 4- and 6-hydroxy-memantine, and 1-nitroso-3,5-dimethyl-adamantane.
Dutch: Il-metaboli ewlenin fil-bniedem huma N-3,5-dimethylgludantan, it-taħlita ta' 4- u 6-hydroxy-memantine, u 1-nitroso-3,5-dimethyl-adamantane.
English: Fertility
Dutch: Fertilità
English: Psychotic reactions2
Dutch: Mhux magħruf Reazzjonijiet psikotiċi2
English: PHARMACOLOGICAL PROPERTIES 5.1 Pharmacodynamic properties
Dutch: 5.1 Proprjetajiet farmakodinamiċi
English: Axura 5 mg+10 mg+15 mg+20 mg film-coated tablets EU/1/02/218/016
Dutch: Axura 5 mg+10 mg+15 mg+20 mg pilloli miksijin b'rita EU/1/02/218/016
English: Content of the pack and other information
Dutch: Kontenut tal-pakkett u informazzjoni oħra
English: Studies in volunteers have demonstrated linear pharmacokinetics in the dose range of 10 to 40 mg. Pharmacokinetic/pharmacodynamic relationship
Dutch: Studji f'voluntiera wrew farmakokinetika linejari f'medda ta' dożi minn 10 sa 40 mg. Relazzjoni farmaokinetika/farmakodinamika
English: Each tablet contains 5/10/15/20 mg of memantine hydrochloride equivalent to 4.15/8.31/12.46/16.62 mg memantine.
Dutch: Kull pillola fiha 5/10/15/20 mg memantine hydrochloride li hi ekwivalenti għal 4.15/8.31/12.46/16.62 mg memantine.
English: Elimination
Dutch: Eliminazzjoni
English: Other medicines and Axura
Dutch: Mediċini oħra u Axura
English: Axura 10 mg tablets
Dutch: Axura 10 mg pilloli
English: Confusion
Dutch: Konfużjoni
English: Blister packs containing either 7, 10, 14 or 20 tablets per blister strip (Alu/PP).
Dutch: Pakketti b'folji li fihom jew 7, 10, 14 jew 20 pillola f'kull strixxa (Alu/PP).
English: An updated RMP should be submitted:
Dutch: RMP aġġornat għandu jiġi ppreżentat:
English: Blister packs containing 14 film-coated tablets per PVDC/PE/PVC/Al-blister or PP/Al-blister strip.
Dutch: Pakketti b'folji li fihom 14-il pillola miksija b'rita għal PVDC/PE/PVC/Al jew folja strixxa ta' PP/Al.
English: LIST OF EXCIPIENTS PHARMACEUTICAL FORM AND CONTENTS
Dutch: LISTA TA' EĊĊIPJENTI GĦAMLA FARMAĊEWTIKA U KONTENUT
English: CLINICAL PARTICULARS 4.1 Therapeutic indications
Dutch: TAGĦRIF KLINIKU 4.1 Indikazzjonijiet terapewtiċi
English: 50 ml (and 10 x 50 ml) in brown glass bottles (Hydrolytic Class II) and 100 ml in brown glass bottles (Hydrolytic Class III).
Dutch: 50 ml (u 10 x 50 ml) fi fliexken tal-ħġieġ kannella (Idrolitiċi Klassi II) u 100 ml fi fliexken tal-ħġieġ kannella (Idrolitiċi Klassi III).
English: Gait abnormal
Dutch: Mixja anormali
English: The volume of distribution is around 10 l/kg.
Dutch: Il-volum ta' distribuzzjoni huwa madwar 10 l/kg.
English: For a full list of excipients, see section 6.1.
Dutch: Għal-lista kompleta ta' sustanzi mhux attivi, ara sezzjoni 6.1.
English: There is one published case report on a possible risk also for the combination of memantine and phenytoin.
Dutch: Hemm rapport wieħed ta' każ li kien publikat dwar riskju li jista' jkun hemm meta memantine jingħata ma' phenytoin.
English: CARTON AND LABEL FOR 50 ml BOTTLE AS INTERMEDIATE PACK / COMPONENT OF A MULTIPACK (WITHOUT BLUE BOX)
Dutch: KARTUNA U TIKKETTA GĦAL FLIXKUN TA' 50 ml BHALA PAKKETT INTERMEDJU / KOMPONENT TA' MULTIPAKK (MINGĦAJR IL-KAXXA BLU)
English: Adverse reactions are ranked according to system organ class, using the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to
Dutch: Ir-reazzjonijiet avversi huma mniżżla skond il-klassi tas-sistema ta' l-organi, bil-konvenzjoni li ġejja: komuni ħafna (≥1/10) komuni (≥1/100 sa <1/10), mhux komuni (≥1/1,000 sa <1/100), rari (≥1/10,000 sa <1/1,000), rari ħafna (<1/10,000), mhux magħruf (ma jistgħax ikun stmat mit-tagħrif li hemm).
English: Titanium dioxide (E 171) Iron oxide yellow (E 172)
Dutch: Titanium dioxide (E 171) Iron oxide isfar (E 172)
English: • Other active substances such as cimetidine, ranitidine, procainamide, quinidine, quinine and nicotine that use the same renal cationic transport system as amantadine may also possibly interact with memantine leading to a potential risk of increased plasma levels.
Dutch: • Sustanzi attivi bħal cimetidine, ranitidine, procainamide, quinidine, quinine u nicotine li jużaw l-istess sistema ta' trasport ketajoniku renali bħal amantadine jistgħu ukoll jinteraġixxu ma' memantine u b'hekk jista' jkun hemm riskju ta' livelli ogħla fil-plażma.
English: The renal elimination rate of memantine under alkaline urine conditions may be reduced by a factor of 7 to 9 (see section 4.4).
Dutch: Ir-rata ta' eliminazzjoni renali ta' memantine taħt kondizzjonijiet ta' awrina alkalina tista' titnaqqas b'fattur ta' 7 għal 9 (ara sezzjoni 4.4).
English: Axura 5 mg, 10 mg, 15 mg, 20 mg film-coated tablets Memantine hydrochloride
Dutch: Axura 5 mg, 10 mg, 15 mg, 20 mg pilloli miksija b'rita Memantine hydrochloride
English: Potassium sorbate Sorbitol E 420
Dutch: Potassium sorbate Sorbitol (E 420) Ilma purifikat
English: 5.2 Pharmacokinetic properties
Dutch: 5.2 Tagħrif farmakokinetiku
English: In volunteers with normal kidney function, total clearance (Cltot) amounts to 170 ml/min/1.73 m² and part of total renal clearance is achieved by tubular secretion.
Dutch: F'voluntiera b'funzjoni tal-kliewi normali, it-tneħħija totali (Cltot) kienet 170 ml/min/1.73 m2 u parti mit-tneħħija renali totali tinkiseb bi tnixxija tubulari.
English: Respiratory, thoracic and mediastinal disorders
Dutch: Disturbi respiratorji, toraċiċi u medjastinali
English: Hallucinations1
Dutch: Alluċinazzjonijiet1
English: The active substance is memantine hydrochloride.
Dutch: Is-sustanza attiva hi memantine hydrochloride.
English: Uncommon (may affect up to 1 in 100 users):
Dutch: Mhux komuni (jistgħu jaffettwaw sa persuna minn kull 100 utenti):
English: STATEMENT OF ACTIVE SUBSTANCE(S)
Dutch: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA
English: EU/1/02/218/022 840 film-coated tablets (20 packs of 42) EU/1/02/218/029 840 film-coated tablets (20 packs of 42)
Dutch: EU/1/02/218/022 840 pilloli miksijin b'rita (20 x 42) EU/1/02/218/029 840 pilloli miksijin b'rita (20 x 42)
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Dutch: Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe wieћed mill-eċċipjenti elenkati fis sezzjoni 6.1.
English: Axura 5 mg, 10 mg, 15 mg, 20 mg tablets
Dutch: Axura pilloli ta' 5 mg, 10 mg, 15 mg, 20 mg
English: week 1
Dutch: ġimgħa 1
English: Axura 20 mg film-coated tablets EU/1/02/218/017
Dutch: Axura 20 mg pilloli miksijin b'rita EU/1/02/218/017
English: 6.5 Nature and contents of container
Dutch: 6.5 In-natura tal-kontenitur u ta' dak li hemm ġo fih
English: • There may be a possibility of reduced serum level of hydrochlorothiazide (HCT) when memantine is co-administered with HCT or any combination with HCT.
Dutch: • Jista' jkun hemm possibilità ta' livelli ta' hydrochlorthiazide (HCT) imnaqqsa fis-serum meta memantine jingħata ma' HCT jew kwalunkwe taħlita ma' HCT.
English: • Seizures
Dutch: • Aċċessjonijiet
English: Axura 5 mg+10 mg+15 mg+20 mg film-coated tablets Each pack contains 28 film-coated tablets in 4 PVDC/PE/PVC/Al-blister or PP/Al-blisters with 7 filmcoated tablets of 5 mg, 7 film-coated tablets of 10 mg, 7 film-coated tablets of 15 mg and 7 film-coated tablets of 20 mg.
Dutch: Axura 5 mg+10 mg+15 mg+20 mg pilloli miksijin b'rita Kull pakkett fih 28 pillola miksija b'rita f'4 folji ta' PVDC/PE/PVC/Al jew folji ta' PP/Al għal 7 pilloli miksijin b'rita ta' 5 mg, 7 pilloli miksijin b'rita ta' 10 mg, 7 pilloli miksijin b'rita ta' 15 mg, 7 pilloli miksijin b'rita ta' 20 mg.