FrancophonIA/ELRC3.0 huggingface dataset:
English: Do not use Foscan - if you are allergic to temoporfin or any of the other ingredients of this medicine (listed in section 6), - if you are hypersensitive (allergic) to porphyrins, - if you have porphyria, or any other disease that is made worse by light, - if the tumour being treated goes through a large blood vessel, - if you are going to have an operation in the next 30 days, - if you have an eye disease which needs examination with bright light in the next 30 days, - if you are already being treated with a photosensitising agent.
Maltese: Tużax Foscan - jekk inti allerġiku għal temoporfin jew għal xi sustanza oħra ta' din il-mediċina (elenkati fis sezzjoni 6). - jekk tbati minn sensittività eċċessiva (allerġija) għal porphyrins - jekk għandek porfirja jew mard ieħor li jista' jiggrava bid-dawl - jekk it-tumur li qed jiġi kkurat jgħaddi minn xi vina/arterja prinċipali - jekk se tagħmel xi operazzjoni fi żmiem 30 ġurnata - jekk għandek mard f'għajnejk li jeħtieġ li jiġi eżaminat b'dawl qawwi fit-30 ġurnata li jmiss - jekk diġà qed tiġi kkurat permezz ta' sustanza fotosensitizzanti
English: Photosensitivity reactions may occur, however, complying with the light protection guidelines (see above section 4.4) and avoiding unnecessary indoor light during illumination reduces this risk.
Maltese: Madankollu, il-konformità mal-linji gwida għallprotezzjoni mid-dawl (ara sezzjoni 4.4, iktar ‘il fuq) u li jiġi evitat dawl bla bżonn fuq ġewwa matul lilluminazzjoni, inaqqsu dan ir-riskju.
English: Two major metabolites of temoporfin are eliminated into the bile.
Maltese: Żewġ metaboli ewlenin ta' temoporfin huma eliminati fil-bile.
English: Foscan is indicated for the palliative treatment of patients with advanced head and neck squamous cell carcinoma failing prior therapies and unsuitable for radiotherapy, surgery or systemic chemotherapy.
Maltese: Foscan hu intiż biex itejjeb il-kondizzjoni ta' pazjenti b'karċinoma avvanzata taċ-ċelluli skwamużi fir-ras u fl-għonq wara l-falliment ta' terapiji preċedenti u meta radjoterapija, kirurġija jew kemoterapija sistematika ma jkunux adattati għalihom.
English: Events occurring at a frequency not known (frequency cannot be estimated from the available data):
Maltese: Avvenimenti li jseħħu bi frekwenza mhux magħrufa (ma tistax tittieħed stima tal-frekwenza mid-data disponibbli):
English: Haemorrhage
Maltese: Fistula
English: Such a reaction has been reported with topical 5-fluorouracil.
Maltese: Reazzjoni bħal din kienet irrapportata flimkien ma' 5-fluorouracil topiku.
English: Attach the filter to the syringe (Figure 2).
Maltese: Waħħal il-filtru mas-siringa (Stampa 2).
English: biolitec Pharma Ltd. Otto-Schott-Str. 15 07745 Jena Germany
Maltese: 15 07745 Jena Il-Ġermanja
English: Foscan is a porphyrin photosensitising medicine, which increases your sensitivity to light and is activated by light from a laser in a treatment called photodynamic therapy.
Maltese: Foscan huwa, mediċina porfirina fotosensitizzanti li żżid is-sensittività tiegħek għad-dawl u li tiġi attivata permezz ta' dawl minn laser f'kura msejħa terapija fotodinamika.
English: Published clinical research has shown that the duration and intensity of photosensitivity at the recommended dose of 0.15 mg/kg were reduced by one third relative to a dose of 0.3 mg/kg.
Maltese: Riċerka klinika ppublikata wriet li t-tul u l-intensità ta' fotosensittività meta ngħatat doża rakkomandata ta' 0.15 mg/kg tnaqqsu b'terz meta mqabbla ma' doża ta' 0.3 mg/kg.
English: Fertility
Maltese: Ċikatriċi
English: For treatment of other types of pain listed in this section, please see section 4.4.
Maltese: Għal kura ta' tipi oħrajn ta' wġigħ elenkati f'din sezzjoni, jekk jogħġbok ara sezzjoni 4.4.
English: Most people will be able to go back to their normal routine by Day 22.
Maltese: Il-parti l-kbira tan-nies jerġgħu lura għar-rutina normali wara madwar 22 ġurnata.
English: Regarding the tabulated adverse reactions gastrointestinal disorders, adverse skin reactions and general disorders and administration site conditions are the most frequently observed adverse reactions.
Maltese: Dwar il-lista ta' reazzjonijiet avversi, disturbi gastrointestinali, reazzjonijiet avversi tal-ġilda u disturbi ġenerali u kondizzjonijiet ta' mnejn jingħata huma l-iktar reazzjonijiet avversi osservati b'mod frekwenti.
English: • Burns
Maltese: • Nawseja
English: Attach the syringe and filter to the cannula.
Maltese: Waħħal is-siringa u l-filtru mal-kannula.
English: ADMINISTRATION OF FOSCAN (96 hours prior to laser illumination of treatment site)
Maltese: L-GĦOTI TA' FOSCAN (96 siegħa qabel l-illuminazzjoni bil-laser tas-sit li qed jiġi ikkurat)
English: Pain in the photoactivated area, e.g. facial pain, headache, injection site pain, oedema in the photoactivated area, e.g. face oedema, tongue oedema
Maltese: Uġigħ fiż-żona fotoattivata, eż. uġigħ fil-wiċċ, uġigħ ta' ras, uġigħ fis-sit tal-injezzjoni, edema fiż-żona fotoattivata, eż. edema tal-wiċċ, edema tal-ilsien
English: The local adverse reactions are characteristic of an acute tissue inflammatory response induced by photoactivation and commonly include oedema and pain followed by necrosis (see section 4.4).
Maltese: Ir-reazzjonijiet avversi lokali huma karatteristiċi ta' rispons infjammatorju akut tat-tessut ikkaġunat minn fotoattivazzjoni u spiss jinkludu edema u wġigħ segwiti minn nekrożi (ara sezzjoni 4.4).
English: The pharmacological activity is initiated by photoactivation of temoporfin with non-thermal light at 652 nm following intravenous administration.
Maltese: L-attività farmakoloġika tibda b'fotoattivazzjoni ta' temoporfin b'dawl mhux termali ta' 652 nm wara li jingħata ġol-vina.
English: Ethanol anhydrous and propylene glycol (see package leaflet for further information)
Maltese: Ethanol mhux idrat u propylene glycol (ara l-fuljett tat-tagħrif għal aktar informazzjoni)
English: •Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Maltese: •Kull meta s-sistema tal-ġestjoni tar-riskju tiġi modifikata speċjalment minħabba li tasal informazzjoni ġdida li tista' twassal għal bidla sinifikanti fil-profil bejn il-benefiċċju u r-riskju jew minħabba li jintlaħaq għan importanti (farmakoviġilanza jew minimizzazzjoni tar-riskji).
English: Respiratory, thoracic and mediastinal disorders Unknown: Airway obstruction
Maltese: Disturbi respiratorji, toraċiċi u medjastinali
English: • There may be some irritation, a burning sensation or skin damage where Foscan is injected,
Maltese: • Jista' jkun hemm xi irritazzjoni, sensazzjoni ta' ħruq jew ħsara lill-ġilda fejn ġie injettat Foscan,
English: Vomiting, nausea, mouth ulceration
Maltese: Remettar, nawseja, ulċerazzjoni tal-ħalq
English: Talk to your doctor for more information.
Maltese: Kellem lit-tabib tiegħek għal aktar informazzjoni.
English: Each pack contains 1 glass vial and a filter.
Maltese: Kull pakkett fih kunjett tal-ħġieġ wieħed u filtru.
English: B. PACKAGE LEAFLET
Maltese: IL-KONTENUT TAL-PAKKETT
English: The incident light dose is 20 J/cm 2, delivered by the microlens fibre-optic in a circular field to the tumour surface at an irradiance of 100 mW/cm 2, implying an illumination time of 200 seconds.
Maltese: J/ċm2, imwassla permezz tal-mikrolens tal-fibra ottika b'moviment ċirkolari fil-wiċċ tat-tumur b'irridazzjoni ta' 100 mW/ċm fil-wiċċ tat-tumur, li jimplika ħin ta'
English: Common side effects (may affect up to 1 in 10 people):
Maltese: Effetti sekondarji komuni (jistgħu jaffettwaw sa 1 f'10 persuni):
English: • Fistula in the treated area
Maltese: • Fistula fiż-żona kkurata
English: Musculoskeletal, connective tissue and bone disorders
Maltese: Disturbi muskolu-skeletriċi u tat-tessuti konnettivi
English: Foscan is administered via an in-dwelling intravenous cannula in a large proximal limb vein, preferably in the antecubital fossa, as a single slow intravenous injection over not less than 6 minutes.
Maltese: Foscan jingħata permezz ta' kannula li titpoġġa f'vina qrib tar-riġel/driegħ, preferibbilment fil-fossa antekubitali, bħala injezzjoni waħda, bil-mod, ġol-vina, f'mhux anqas minn 6 minuti.
English: • Giddiness
Maltese: • Rimettar
English: Administer the required dose of Foscan by slow intravenous injection, over not less than 6 minutes (Figure 4).
Maltese: Agħti d-doża meħtieġa ta' Foscan b'injezzjoni bil-mod ġolvina, fuq medda ta' mhux anqas minn 6 minuti (Stampa 4).
English: There is potential for exacerbation of skin photosensitivity if temoporfin is used with other photosensitising active substances.
Maltese: Hemm il-possibbilità li l-fotosensittività tal-ġilda tmur għall-agħar jekk temoporfin jintuża ma' sustanzi oħra fotosensitizzanti attivi.
English: Each pack provides 1 vial containing 1 ml, 3 ml or 6 ml solution for injection.
Maltese: Kull pakkett jipprovdi 1 kunjett li jkun fih 1 ml, 3 ml jew 6 ml ta' soluzzjoni għall-injezzjoni.
English: Normally, people are able to begin to return to normal outdoor lighting after 15 days.
Maltese: Normalment, il-persuni jistgħu jerġgħu lura għad-dawl normali ta' barra wara 15-il ġurnata.
English: Tumour responses are enhanced in patients with fully illuminated lesions of 10 mm or less in depth.
Maltese: Ir-riżultati fuq it-tumur kienu mtejjba f'pazjenti b'feriti lluminati kompletament fi profondità ta' 10 mm jew anqas.
English: Each ml contains 1 mg of temoporfin.
Maltese: U KWANTITATTIVA Kull ml fih 1 mg ta' temoporfin.
English: Limited data are available on the elimination of temoporfin in humans.
Maltese: Hemm informazzjoni ristretta disponibbli dwar l-eliminazzjoni ta' temoporfin fil-bniedem.
English: PHARMACOLOGICAL PROPERTIES
Maltese: biolitec Pharma
English: Thermal burn, sunburn
Maltese: UŻATI JEW SKART MINN DAWN
English: Localised infection in the area of photoactivation, e.g. pharyngitis, stomatitis Unknown:
Maltese: Infezzjoni lokalizzata fiż-żona talfotoattivazzjoni, eż. farinġite, stomatite Mhux magħrufa:
English: Draw up the entire contents of the vial containing Foscan into a syringe and expel air (Figure 1).
Maltese: Iġbed il-kontenut kollu tal-kunjett li fih Foscan f'siringa u neħħi l-arja (stampa 1).
English: Illumination of the tumour should only be carried out if the potential benefit justifies the potential risk of excessive necrosis.
Maltese: Illuminazzjoni tat-tumur għandha ssir biss jekk il-benefiċċju potenzjali jiġġustifika r-riskju potenzjali ta' nekrożi eċċessiva.
English: A WHO local complete response was observed in 14 % of patients.
Maltese: Effett lokali komplut skont ilWHO ġie osservat f'14% tal-pazjenti.
English: Adverse reactions, including cholangitis, cholecystitis, liver abscess and oesophageal perforation have been reported after unapproved use in the treatment of malignant biliary strictures and mesothelioma.
Maltese: Reazzjonijiet avversi, li jinkludu kolanġite, koleċistite, axxess tal-fwied u perforazzjoni tal-esofagu, ġew irrappurtati wara l-użu mhux approvat fil-kura ta' kontrazzjonijiet biljari malinni u mesoteljoma.
English: The excipients are ethanol anhydrous and propylene glycol.
Maltese: Is-sustanzi mhux attivi huma ethanol mhux idrat u Ppropylene glycol.
English: • Vomiting
Maltese: • Mejt
English: Common: Trismus Unknown: Fistula
Maltese: • Kalzetti: għas-saqajn u l-għekiesi
English: Each pack contains 1 vial and a filter with Luer lock connections for syringe and cannula.
Maltese: Kull pakkett fih kunjett wieħed u filtru b'konnessjonijiet biex jista' jeħel mas-siringa u mal-kannula b'Luer lock.
English: Common: Dizziness, burning sensation
Maltese: Komuni: Sturdament, sensazzjoni ta' ħruq
English: The incident light dose is 20 J/cm 2, delivered at an irradiance of 100 mW/cm to the tumour surface,
Maltese: J/ċm2, imwassla b'irradjazzjoni ta' 100 mW/ċm2 fil-wiċċ tat-tumur,
English: Very common:
Maltese: Komuni ħafna:
English: An extensive volume of distribution is observed that is intermediate between total and extracellular body water.
Maltese: Kien osservat volum ta' distribuzzjoni estensiv li hu intermedju bejn l-ilma totali u ilma extraċellulari tal-ġisem.
English: Light must be administered not less than 90 hours and not more than 110 hours after Foscan injection.
Maltese: Id-dawl għandu jingħata għal mhux anqas minn 90 siegħa u mhux aktar minn 110 sigħat wara li tingħata l-injezzjoni ta' Foscan.
English: Foscan must be administered intravenously via an in-dwelling cannula in a large proximal limb vein, preferably in the antecubital fossa.
Maltese: Foscan għandu jingħata permezz ta' kannula f'vina qrib tar-riġel/driegħ, preferibbilment fil-fossa antekubitali.
English: Marketing Authorisation Holder and Manufacturer biolitec Pharma Ltd. Otto-Schott-Str. 15 07745 Jena
Maltese: Il-kondizzjoni tal-kannula mdaħħla fil-vina għandha tkun eżaminata qabel kull injezzjoni u għandha tittieħed kull prekawzjoni kontra l-estravażjoni (ara sezzjoni 4.4).
English: You can then repeat the test.
Maltese: DATA TA' REVIŻJONI TAT-TEST
English: This risk can be controlled in the clinical situation by minimising direct exposure to light (see section 4.4).
Maltese: Dan ir-riskju jista' jiġi kkontrollat fis-sitwazzjoni klinika billi titnaqqas l-espożizzjoni diretta għad-dawl (ara sezzjoni 4.4).
English: It is unknown whether temoporfin/metabolites are excreted in human milk.
Maltese: Mhux magħruf jekk temoporfin/metaboliti jiġux eliminat mill-ħalib tas-sider tal-bniedem.
English: • Your doctor or nurse will give you Foscan by a slow injection into a vein, which will take approximately 6 minutes.
Maltese: • It-tabib jew l-infirmiera tiegħek se jagħtuk Foscan b'injezzjoni bil-mod ġol-vina li ser tieħu madwar 6 minuti.
English: • Sunburn
Maltese: OĦRAJN
English: VIAL LABEL OF 1 MG/ML
Maltese: Ż-ŻGĦAR EWLENIN TIKKETTA TAL-KUNJETT TA' 1 MG/ML
English: Foscan photodynamic therapy must only be administered in specialist oncology centres in which a multidisciplinary team assesses patient treatment and under the supervision of physicians experienced in photodynamic therapy.
Maltese: It-terapija fotodinamika permezz ta' Foscan għandha tingħata biss f'ċentri speċjalizzati ta' l-onkoloġija fejn skwadra multidixxiplinarja tanalizza l-kura tal-pazjent li jkun taħt is-superviżjoni ta' tobba b'esperjenza fit-terapija fotodinamika.
English: Single dose.
Maltese: Doża waħda.
English: On the basis of the pharmacodynamic profile, temoporfin is presumed to be safe or unlikely to produce an effect.
Maltese: Abbażi tal-profil farmakodinamiku, wieħed jista' jassumi li temoporfin mhux perkuluż jew mhux mistenni li jipproduċi xi effett.
English: High rates of administration caused death in dogs and rabbits.
Maltese: Disturbi ġenerali u kondizzjonijiet ta' mnejn jingħata
English: By 15 days post-infusion, temoporfin plasma concentration has declined to background such that patients are generally able to begin a gradual return to normal outdoor lighting conditions.
Maltese: Sa 15-il jum wara l-infużjoni, il-konċentrazzjoni ta' temoporfin fil-plażma naqset għal-livelli baxxi b'tali mod li l-pazjenti ġeneralment ikunu jistgħu jerġgħu jirritornaw gradwalment għal kondizzjonijiet normali tad-dawl ta' barra.
English: The median observed duration of tumour response for all patients was 57 days for overall response and 84 days for complete response.
Maltese: Iż-żmien medju ta' kemm dam l-effett fuq it-tumur għall-pazjenti kollha kien ta' 57 jum għar-riżultat ġenerali u 84 jum għar-riżultat komplut.
English: Type I amber glass vials with a bromobutyl elastomer stopper and aluminium seal containing either 1 ml or 3 ml or 6 ml of solution for injection.
Maltese: Il-biċċa l-kbira mill-effetti sekondarji relatati ma' terapija fotodinamika huma effetti lokali li jidhru bħala konsegwenza tal-attivazzjoni ta' Foscan bil-laser.
English: Paediatric population There is no relevant use of Foscan in the paediatric population.
Maltese: M'hemm l-ebda użu rilevanti ta' Foscan fit-tfal.
English: For 3 months following Foscan treatment, avoid UV tanning beds.
Maltese: Għal 3 xhur wara l-kura b' Foscan, evita li tixxemmex b'soddod tal-UV.
English: Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2)
Maltese: Prodott mediċinali li jingħata b'riċetta ristretta tat-tabib (Ara Anness I: Sommarju tal-Karatteristiċi tal-Prodott, sezzjoni 4.2).
English: How to store Foscan
Maltese: Jekk tingħata aktar Foscan milli suppost
English: • You may be sensitive to light for more than 15 days.
Maltese: • Tista' tkun sensittiv għal dawl għal aktar minn 15-il ġurnata.
English: For 6 months following Foscan treatment, care should be taken to avoid direct prolonged sunlight exposure of the arm used for Foscan injection.
Maltese: Għandhom jittieħdu l-prekawzjonijiet kollha biex tiġi evitata l-illuminazzjoni diretta tal-pazjenti b'lampi tal-kirurġija matul dawn il-proċeduri.
English: • Long sleeved top: for upper body/arms.
Maltese: • Qalziet twil: għall-parti t'isfel tal-ġisem/riġlejn
English: Foscan shall not be diluted nor flushed with sodium chloride or any other aqueous solution.
Maltese: Foscan m'għandux jiġi dilwit u lanqas imħallat ma' sodium chloride jew ma' xi soluzzjoni akweja oħra.
English: Please refer to the laser user manual, and to the microlens fibre-optic user leaflet.
Maltese: Jekk jogħġbok irreferi għall-manwal għall-użu tal-laser, u għall-fuljett ta' tagħrif tal-mikrolens tal-fibra ottika.
English: It is therefore important that during photoactivation by laser illumination care should be taken to protect normal tissue surrounding the tumour from photoactivation by proper illumination and shielding techniques.
Maltese: Madankollu, ma kien hemm lebda sinjali oħrajn ta' tossiċità fil-klieb ittrattati bid-doża terapewtika rrakkomandata, għalkemm l-espożizzjoni sistemika kienet aktar minn dik tal-bniedem.
English: Peak plasma levels occur at 2-4 hours post-injection thereafter plasma levels decline in a bi-exponential manner.
Maltese: L-ogħla livelli fil-plażma jintlaħqu wara 2-4 sigħat wara l-injezzjoni, u għalhekk illivelli fil-plażma jonqsu b'mod bi-esponenzjali.
English: Name and address of the manufacturer responsible for batch release biolitec Pharma Ltd. Otto-Schott-Str. 15 07745 Jena Germany
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediċinali tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu
English: Light must be delivered to the entire surface of the tumour using an approved microlens fibre-optic.
Maltese: Id-dawl għandu jasal fuq il-wiċċ kollu tat-tumur permezz ta' mikrolens tal-fibra ottika, approvat.
English: Wherever possible, the illuminated area must extend beyond the tumour margin by a distance of 0.5 cm.
Maltese: Kull meta jkun possibli, il-parti lluminata għandha taqbeż il-marġini tat-tumur b'distanza ta' 0.5 ċm.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Maltese: Isem u indirizz tal-manifattur tas-sustanza bijoloġika attiva biolitec Pharma
English: B-1070 Brussels
Maltese: B-1070 Brussels Belgium
English: Box 12
Maltese: P.O. Box 12
English: Budaörs H-2040
Maltese: H-2040
English: Liljeholmsstranden 5 Box 47327
Maltese: Roche AB Liljeholmsstranden 5 Box 47327
English: Roche Eesti OÜ Lõõtsa 2, 11415 Tallinn, Estonia
Maltese: Roche Eesti OÜ Lõõtsa 2, 11415
English: Roche Polska Sp. z o.o.
Maltese: Roche Polska Sp. z o.o. ul.
English: Luxembourg N.V. Roche S.A. Rue Dante 75
Maltese: N.V. Roche S.A. Rue Dante 75
English: Dukelských hrdinů 567/52, 170 00 Praha 7
Maltese: Dukelských hrdinů 567/52,
English: Roche A/S Industriholmen 59 2650 Hvidovre Denmark
Maltese: Roche A/S Industriholmen 59 2650
English: Roche Norge AS Brynsengfaret 6B Postboks 6610 Etterstad 0607 Oslo
Maltese: In-Norveġja Roche Norge AS Brynsengfaret 6B Postboks 6610
English: Roche România SRL Piata Presei Libere , Nr. 3-5, Clădirea City Gate -Turnul de Sud, Etajele 4A, 5 şi 6, Sector 1, Bucureşti
Maltese: Clădirea City Gate -Turnul de Sud, Etajele 4A, 5 şi 6, Sector 1, Bucureşti, România
English: Roche Oy Klovinpellontie 3 P.O.
Maltese: Il-Finlandja Roche Oy Klovinpellontie 3
English: UAB “Roche Lietuva” J.Jasinskio str. 16B LT-03163 Vilnius Lithuania
Maltese: Il-Litwanja UAB “Roche Lietuva” J.Jasinskio str. 16B
English: Roche Bulgaria EOOD 16, Byalo pole Str. 1618 Sofia, Bulgaria
Maltese: Il-Bulgarija Roche Bulgaria EOOD 16, Byalo pole Str.
English: United Kingdom Roche Products Limited, 6 Falcon Way, Shire Park, Welwyn Garden City,
Maltese: Ir-Renju Unit Roche Products Limited, 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW,
English: The Netherlands Roche Nederland B.V. Beneluxlaan 2a
Maltese: Roche Nederland B.V. Beneluxlaan 2a 3446 GR Woerden The Netherlands
English: Cymevene "Roche" 500 mg - Trockensubstanz zur Infusionsbereitung
Maltese: Cymevene "Roche" 500 mgTrockensubstanz zur Infusionsbereitung
English: ul.
Maltese: G. A.
English: Roche Pharma AG Emil-Barell-Straße 1 79639 Grenzach-Wyhlen Germany
Maltese: 79639 Grenzach-Wyhlen Germany
English: Roche Austria GmbH Engelhorngasse 3 1211 Vienna Austria
Maltese: L-Awstrija Roche Austria GmbH Engelhorngasse 3
English: Roche (Hungary) Ltd. Edison str 1.
Maltese: L-Ungerija Roche (Hungary) Ltd.
English: G. A. Stamatis & Co. Ltd. 27, Andreas Araouzos P.O.
Maltese: Ltd. 27, Andreas Araouzos P.O. Box 21305
English: 500 mg Lyophilisate for parenteral use (infusion)
Maltese: 500 mg Lajofiliżat għall-użu parenterali (infużjoni)
English: Roche AB
Maltese: ANNESS I
English: Denmark
Maltese: Hvidovre Denmark
English: AL7 1TW,
Maltese: Edison str 1.
English: Slovak Republic Roche Slovensko s.r.o.
Maltese: Cymevene 500 mg pulbere pentru soluţie perfuzabilă ls-Slovakkja Roche Slovensko s.r.o.
English: The in vivo micronucleus test was negative.
Maltese: It test tal-mikronukleju in vivo kien negattiv.
English: Date of first authorization: 11/12/2009 Date of first renewal: 19/08/2014
Maltese: Data tal-ewwel awtorizzazzjoni: 11/12/2009 Data tal-ewwel tiġdid: 19/08/2014
English: D-82041 Oberhaching Germany
Maltese: D-82041 Oberhaching
English: In vitro, this metabolite shows minimal inhibition of acetylcholinesterase (<10%).
Maltese: In vitro din is-sustanza li tifforma filmetaboliżmu turi inibizzjoni minima għal acetylcholinesterase (<10 %).
English: Rivastigmine 1 A Pharma 1.5 mg hard capsules Rivastigmine 1 A Pharma 3 mg hard capsules Rivastigmine 1 A Pharma 4.5 mg hard capsules Rivastigmine 1 A Pharma 6 mg hard capsules
Maltese: Rivastigmine 1 A Pharma 1.5 mg kapsuli ibsin Rivastigmine 1 A Pharma 3 mg kapsuli ibsin Rivastigmine 1 A Pharma 4.5 mg kapsuli ibsin Rivastigmine 1 A Pharma 6 mg kapsuli ibsin
English: Adverse reactions in Table 1 and Table 2 are listed according to MedDRA system organ class and frequency category.
Maltese: Ir-reazzjonijiet avversi ppreżentati f'Tabella 1 u f'Tabella 2 huma kklassifikati skond is-sistema tal-klassi tas sistema ta' l-organu (tal-MedDRA) u l-kategorija tal-frekwenza.
English: Capsule fill:
Maltese: Kapsula ibsin
English: - Printing ink: - Shellac - Titanium dioxide (E171)
Maltese: - Shellac - Titanium dioxide (E171)
English: Rivastigmine 1 A Pharma 2 mg/ml oral solution
Maltese: Rivastigmine 1 A Pharma 2 mg/ml soluzzjoni orali
English: The major metabolite NAP226-90 also did not show a genotoxic potential.
Maltese: Il metabolit ewlieni NAP226-90 ma weriex potenzjal ġenotossiku wkoll.
English: Total plasma clearance of rivastigmine was approximately 130 l/h after a 0.2 mg intravenous dose and decreased to 70 l/h after a 2.7 mg intravenous dose.
Maltese: 0.2 mg it-tneħħija totali mill-plażma ta' rivastigmine kienet ta' bejn wieħed u ieħor 130 l/h, u din naqset għal 70 l/h wara doża minn ġol-vini ta' 2.7 mg.
English: - The other ingredients are hypromellose, magnesium stearate, microcrystalline cellulose, colloidal anhydrous silica, gelatin, yellow iron oxide , red iron oxide , titanium dioxide and shellac.
Maltese: - Is-sustanzi l-oħra huma hypromellose, magnesium stearate, microcrystalline cellulose, colloidal anhydrous silica, gelatin, yellow iron oxide (E172), red iron oxide (E172), titanium dioxide (E171)u shellac.