FrancophonIA/ELRC3.0 huggingface dataset:
English: For the treatment of subclinical mastitis in lactating cows due to Gram-positive cocci susceptible to pirlimycin including staphylococcal organisms such as Staphylococcus aureus, both penicillinase-positive and penicillinase-negative, and coagulase-negative staphylococci; streptococcal organisms including Streptococcus agalactiae, Streptococcus dysgalactiae, and Streptococcus uberis.
Maltese: Għal kura ta' mastite mingħajr sintomi, f'baqar li qed jaħilbu, ikkawżata minn kokki Gram-positive li jirrispondu għall-pirlimycin, u dawn jinkludu mikrobi stafilokoċċi bħal Staphylococcus aureus, kemm l-istafilokoċċi penicillinase-positive kif ukoll penicillinase-negative u coagulase-negative; mikrobi streptokoċċi li jinkludu Streptococcus agalactiae, Streptococcus dysgalactie u Streptococcus uberis.
English: Avoid contact with the solution.
Maltese: Evita li tmiss it-taħlita.
English: Gram-positive isolates with an MIC > 2 µg/ml are to be considered resistant.
Maltese: Iżolati batterjoloġiċi ta' mikrobi Gram-positive b'MIC>2 µg/ml huma meqjusa bħala reżistenti.
English: PHARMACEUTICAL FORM Intramammary solution
Maltese: GĦAMLA FARMAĊEWTIKA Soluzzjoni intramammarja.
English: Do not store above 25 °C.
Maltese: Taħżinx f'temperatura ogħla minn 25°C.
English: PACKAGE SIZE 8 x 10 ml intramammary syringes 24 x 10 ml intramammary syringes 120 x 10 ml intramammary syringes
Maltese: 8 siringi intramammarji x 10 ml.
English: ROUTE(S) OF ADMINISTRATION Intramammary use
Maltese: MOD(I) TA' AMMINISTRAZZJONI Għal użu intramammarju.
English: STATEMENT OF ACTIVE SUBSTANCES Pirlimycin hydrochloride equivalent to 50 mg pirlimycin per 10 ml syringe
Maltese: Pirlimycin hydrochloride ekwivalenti għal 50 mg pirlimycin f'kull siringa ta' 10 ml.
English: WITHDRAWAL PERIOD(S) Meat and offal: 23 days.
Maltese: PERJODU(I) TA' TIŻMIM Laħam u interjuri: 23 ġurnata.
English: They work by binding to the 50S ribosomal subunit, therefore hindering the aminoacyl-tRNA binding and inhibiting the peptidyltransferase reaction, which interferes with protein synthesis within the bacteria.
Maltese: Huma jaħdmu billi jeħlu mal-50S ribosomal subunit, u b'hekk ifixklu l għaqda tal-aminoacyl-tRNA u jimblokkaw ir-reazzjoni tal-peptidyltransferase, li tfixkel is-sintesi ta'proteini fil-mikrobi.
English: Cross-resistance may occur between pirlimycin and other lincosamides or macrolides.
Maltese: Jista' jkun hemm reżistenza inkroċjata bejn il-pirlimycin u lincosamides oħra jew macrolides.
English: Infuse one syringe (50 mg pirlimycin) into each infected quarter.
Maltese: Agħti infużjoni ta' siringa waħda (50 mg pirlimycin) f'kull beżżula infettata.
English: Similar concentrations were reached at 12 and 24 hours after a second infusion at a 24 hour interval.
Maltese: Konċentrazzjonijiet simili intlaħqu wara 12 u 24 tnax u erbgħa u għoxrin siegħa wara t-tieni infużjoni mgħotija wara intervall ta' erbgħa u għoxrin siegħa.
English: The excipients listed in section 6.1 of the SPC are considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Maltese: L-addittivi elenkati f‘sezzjoni 6.1 tas-Sommarju tal-karatteristiċi tal-prodott huma ikunsidrati li ma jaqgħux fi ħdan l-iskop tar-Regolament (KE) Nru 470/2009 meta wżati bħal f'dan il-prodott mediċinali veterinarju.
English: For the treatment of subclinical mastitis in lactating cows due to Gram-positive cocci susceptible to pirlimycin including staphylococcal organisms such as Staphylococcus aureus, both penicillinase-positive and penicillinase-negative, and coagulase-negative staphylococci; streptococcal organisms including Streptococcus agalactiae, Streptococcus dysgalactiae and Streptococcus uberis.
Maltese: Għal kura ta' mastite mingħajr sintomi, f'baqar li qed jinħalbu, ikkawżata minn kokki Gram-positive li jirrispondu għall-pirlimycin, u dawn jinkludu mikrobi staphylokoċċi bħal Staphylococcus aureus, kemm l-istaphylokoċċi penicillinase-positive kif ukoll penicillinase-negative u coagulase-negative;
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Pirlimycin hydrochloride equivalent to 50 mg pirlimycin per 10 ml syringe
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA U SUSTANZI OĦRA Pirlimycin hydrochloride ekwivalenti għal 50 mg pirlimycin f'kull siringa ta' 10 ml.
English: Pharmacotherapeutic group: Antibacterial for intramammary use.
Maltese: Sustanza għal kontra l-mikrobi għal użu intramammarju.
English: Enteric bacteria such as E. coli are intrinsically resistant to pirlimycin.
Maltese: Mikrobi ta' l-imsaren bħal E. coli huma minn natura tagħhom reżistenti għal pirlimycin.
English: Ask your veterinary surgeon or pharmacist how to dispose of medicines no longer required.
Maltese: Staqsi lill-kirurgu veterinarju jew lill-ispiżjar tiegħek dwar kif tarmi l-mediċini li ma jkunux aktar meħtieġa.
English: Care must be taken not to introduce pathogens into the teat in order to reduce the risk of E. coli infections.
Maltese: Kura għal infezzjonijiet ikkawżati minn mikrobi ta' l-imsaren bħal E. coli.
English: PACKAGE LEAFLET: Pirsue 5 mg/ml intramammary solution for cattle
Maltese: Pirsue 5 mg/ml soluzzjoni intramammarja għal-baqar.
English: MANUFACTURER'S BATCH NUMBER Lot{number}
Maltese: NUMRU TAL-LOTT TAL-MANIFATTUR
English: Marketing authorisation holder:
Maltese: Żmien ta' tiżmim:
English: Keep the syringes in the outer carton.
Maltese: Aħsel id-driegħ jekk ikun maħmuġ.
English: Pirlimycin has been shown to accumulate in polymorphonuclear cells, however, intracellular killing of Staphylococcus aureus was not demonstrated.
Maltese: Pirlimycin ġie muri li jakkumula f'ċelloli polimorfonukleari, imma ma ġiex muri li joqtol Staphylococcus aureus fiċ-ċelloli.
English: Tablet
Maltese: Ippakkjar
English: EU/2/98/007/001 Clomicalm 5 mg
Maltese: Numru tal-UE Isem kummerċjali
English: --1 Porcine circovirus type 2 ORF2 protein RP 1.0-3.75 * Relative potency (ELISA test) by comparison with a reference vaccine
Maltese: --1 ORF2 proteina circovirus tal-qżieqeż ta' tip 2 RP 1.0-3.75 * Potenza Relattiva (test ELISA) permezz ta' paragun ma' tilqima ta' referenza
English: EU (MA) number
Maltese: Numru tal-UE
English: MA (EU) number (Invented) name
Maltese: Numru talMA (UE)
English: Pack size l t o r
Maltese: Il-kontenut Daqs tal-pakkett t x
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) NEUPOPEG EPAR summary for the public
Maltese: RAPPORT TA' VALUTAZZJONI PUBBLIKA EWROPEW (EPAR) NEUPOPEG Sommarju ta' l-EPAR għall-pubbliku
English: The active substance in Neupopeg, pegfilgrastim, is an immunostimulant that belongs to the group ‘colony stimulating factors'.
Maltese: Is-sustanza attiva Neupopeg, pegilgrastim hija immunostimulant li jaqa' fil-grupp ta' ‘fatturi ta' stimulazzjoni tal-kolownja'.
English: It consists of filgrastim, a copy of a human protein called granulocyte colony stimulating factor (G-CSF), which has been ‘pegylated' (coated with a chemical called polyethylene glycol).
Maltese: Din tikkonsisti f'filgrastim, kopja ta' proteini umani msejjħas fattur ta' stimulazzjoni tal-kolownja granuloċijto (G-CSF), li kien ġie ‘pegilati' (miksija b'kimika msejjħa glikol polietilenju.
English: The filgrastim in Neupopeg is produced by a method known as ‘recombinant DNA technology': it is made by a bacterium that has received a gene (DNA), which makes it able to produce filgrastim.
Maltese: Il-filgrastim f'Neupopeg jiġi prodott b'metodu magħruf bħala teknoloġija 'rikombinanti tad-DNA': hija magħmula minn batterju li tkun irċiviet ġene (DNA), li jagħmilha kapaċi tipproduċi filgrastim.
English: Why has Neupopeg been approved?
Maltese: Għaliex ġie approvat Neupopeg?
English: The European Commission granted a marketing authorisation valid throughout the EU for Neupopeg to Dompé Biotec S.p.A. on 22 August 2002.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida madwar l-Unjoni Ewropea kollha, għal Neupopeg lil Dompé Biotec S.p.A. fit-22 ta' Awwissu2002.
English: Neupopeg has been studied in two main studies involving 467 patients with breast cancer who were being treated with cytotoxic chemotherapy.
Maltese: Neupopeg ġiet studjata f'żewġ studji prinċipali li jinvolvu 467 pazjent bil-kanċer tas-sider li kienu qed jiġu trattati bil-kemoterapija ċitototossika.
English: What is Neupopeg?
Maltese: Kif jaħdem Neupopeg?
English: What is the risk associated with Neupopeg?
Maltese: X'inhu r-riskju assoċjat ma' Neupopeg?
English: Neupopeg is a solution for injection that contains the active ingredient pegfilgrastim.
Maltese: Neupopeg hu soluzzjoni għall-injezzjoni li fiha s-sustanza attiva pegilgrastim.
English: Filgrastim has been available in other medicines in the European Union (EU) for a number of years.
Maltese: Filgrastim sar disponibbli f'mediċini oħrajn fl-Unjoni Ewropea (EU) għal numru ta' snin.
English: Other information about Neupopeg:
Maltese: Tagħrif ieħor dwar Neupopeg:
English: The Committee for Medicinal Products for Human Use (CHMP) decided that Neupopeg's benefits are greater than its risks for the reduction of the duration of neutropenia and the incidence of febrile neutropenia in patients treated with cytotoxic chemotherapy for malignancy.
Maltese: Il-Kumitat għal Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) ddeċieda li l-benefiċċji ta' Neupopeg huma akbar mir-riskji tagħha għat-tnaqqis taż-żmien ta' newtropenija u l-inċidenza ta' newtropenija febbrili trattata b'kemoterapija ċitotossika kontra l-malinjetà.
English: The replacement acts in same way as naturally produced G-CSF.
Maltese: Issostituzzjoni taħdem bl-istess mod bħal G-CSF alpha prodott b'mod naturali.
English: It is available in a pre-filled syringe and a pre-filled pen (SureClick), each containing 6 mg pegfilgrastim.
Maltese: Huwa disponibbli f'siringa mimlija minn qabel u f'forma ta' pinna mimlija minn qabel (SureClick) li kull waħda fiha 6 mg ta' pegfilgrastim.
English: The marketing authorisation was renewed on 22 August
Maltese: L-awtorizzazzjoni għattqegħid fis-suq ġiet aġġornata fit-22 ta' Awwissu 2007.
English: For the full list of all side effects reported with Neupopeg, see the Package Leaflet.
Maltese: Għal-lista sħiħa ta' l-effetti sekondarji rrapportati b' Neupopeg, ara l-Fuljett ta' Tagħrif.
English: Neupopeg can be used for many types of cancer, except for chronic myeloid leukaemia (a cancer of the white blood cells).
Maltese: Neupopeg jista' jintuża għal bosta tipi ta' kanċer, ħlief il-lewkemja mijelojde kronika (kanċer taċċelloli bojod tad-demm).
English: Neupopeg was as effective as filgrastim in reducing the duration of severe neutropenia.
Maltese: Neupopeg kienet effettiva bħala filgrastim fit-tnaqqis ta' żmien ta' newtropenija severa.
English: Because it is pegylated in pegfilgrastim, the rate at which the medicine is removed from the body is decreased, allowing the medicine to be given less often.
Maltese: Minħabba li huwa pegilat f'pegfilgrastim, ir-rata li biha l-mediċina titneħħa mill-ġisem tonqos, tippermetti li l-mediċina tingħata anqas sikwit.
English: Neupopeg is used to reduce the duration of neutropenia and the occurrence of febrile neutropenia (neutropenia with fever).
Maltese: Neupopeg huwa użat sabiex inaqqas iż-żmien ta' newtropenija u l-każ li jkun hemm newtropenija febbrili (newtropenija bid-deni).
English: The most common side effects with Neupopeg (seen in more than 1 in 10 patients) are bone pain and raised levels of lactate dehydrogenase (a marker of red blood cell breakdown).
Maltese: Bosta effetti sekondarji f'pazjenti li jieħdu Neupopeg fi studji huma dovoti għal marda jew kemoterapija.
English: Neupopeg is given as a single 6 mg injection under the skin around 24 hours after the end of each cycle of chemotherapy.
Maltese: Neupopeg tingħata bħal injezzjoni waħda ta' 6 mg taħt ilġilda madwar 24 siegħa wara t-tmeim ta' kull ċiklu ta' kemoterapija.
English: Packaging Content Package size
Maltese: Ippakkhar Kontenut Daqs talpakkett
English: Withdrawal period
Maltese: Perjodu ta' Tiżmin
English: Target Species
Maltese: Mod ta' Amminist razzjoni
English: This summary was last updated: March 2012.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar Marzu 2012.
English: Meloxivet contains the active substance meloxicam and exists in 2 different strengths (0.5 and 1.5 mg/ml, respectively).
Maltese: Meloxivet fiha sustanza attiva meloxicam u teżisti f'żewġ qawwiet differenti (0.5 u 1.5mg/ml rispettivament).
English: Other information about Meloxivet:
Maltese: Informazzjoni oħra dwar Meloxivet:
English: What are the side-effects of Meloxivet?
Maltese: X'inhuma l-effetti sekondarji ta' Meloxivet ?
English: Meloxivet is a ‘generic': this means that Meloxivet is similar to a ‘reference veterinary medicine' already authorised in the EU (Metacam 1.5 mg/ml oral suspension).
Maltese: Meloxivet huwa ‘ġeneriku' dan ifisser li Meloxivet huwa simili għal ‘mediċina veterinarja ta' referenza' li hija diġà awtorizzata fl-UE (Metacam 1.5mg.ml ta' sospensjoni orali).
English: Occasional side effects of Meloxivet are those seen with NSAIDs, such as loss of appetite, vomiting, diarrhoea, blood appearing in the stools and apathy (lack of vitality).
Maltese: Effetti sekondarji okkażjonali ta' Meloxivet huma dawk li jidhru bil-NSAIDs, bħat-telf ta' aptit, rimetter, dijarrea, demm fil-qlalet u apatija (nuqqas ta' vitalità).
English: Therefore the CVMP's view was that, as for Metacam 1.5 mg/ml oral suspension, Meloxivet's benefits are greater than its risks when treating inflammation or pain in muscles or joints in dogs and they recommended that Meloxivet should be given a marketing authorisation.
Maltese: Għalhekk l-opinjoni tas-CVMP kienet li, l-istess bħal Metacam 1.5 mg/ml ta' sospensjoni orali, il-benefiċċji ta' Meloxivet huma akbar mir-riskji tiegħu meta tiġi trattata linfjammazzjoni jew uġigħ fil-muskoli jew fil-ġogi fil-klieb u rrakomandaw li Meloxivet għandu tingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: If you want more information on the basis of the CVMP recommendations, read the Scientific Discussion (also part of the EPAR).
Maltese: Jekk trid iktar informazzjoni fuq il-bażi tar-Rakkomandazzjonijiet tal-CVMP, aqra d-Diskussjoni Xjentifika (parti wkoll mill-EPAR).
English: Why has Meloxivet been approved?
Maltese: Għaliex ġiet approvata Meloxivet?
English: What is Meloxivet?
Maltese: X'inhi Meloxivet?
English: Meloxivet is used in dogs to relieve inflammation and pain in musculo-skeletal disorders.
Maltese: Meloxivet tintuża fil-klieb sabiex titnaqqas l-infjammazzjoni u l-uġigħ fil-problemi muskuloskeletali.
English: Meloxivet contains meloxicam, which belongs to a class of medicines called nonsteroidal antiinflammatory drugs (NSAIDs).
Maltese: Meloxivet fiha meloxicam li jagħmel parti minn klassi ta' mediċini msejjħa mediċini antiinfjammatorji mhux sterojdi (NSAIDs). Meloxicam jaġixxi billi jinibixxi s-sinteżi tal-prostaglandini.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Meloxivet on 14 November 2007 Information on the prescription status of this product may be found on the label of the carton.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida madwar l-Unjoni Ewropea għal Meloxivet fl-14 ta' Novembru 2007.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) considered that, in accordance with European Union requirements, Meloxivet has been shown to be bioequivalent to Metacam 1.5 mg/ml oral suspension.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu Veterinarju (CVMP) ikkunsidra li, skond ir-rekwiżiti ta' l-Unjoni Ewropea, Meloxivet kien jidher bħala bijoekwivalenti għal Metacam 1.5mg/ml ta' sospensjoni orali.
English: These side effects occur usually within the first week of treatment and are generally transient (temporary).
Maltese: Dawn l-effetti sekondarji jidhru normalment matul l-ewwel ġimgħa tat-trattament u huma ġeneralment temporanji.
English: As the prostaglandins are substances that trigger inflammation, pain, exudation and fever, meloxicam reduces those responses.
Maltese: Minħabba li l-prostaglandini huma sostanzi li jikkawżaw l-infjammazzjoni, uġigħ, għaraq u deni, meloxicam tnaqqas dawn ir-reazzjonijiet.
English: Meloxivet is given to the dog once a day, with food, at the dose of 0.2 mg/kg on the first day, then as 0.1 mg/kg afterwards.
Maltese: Meloxivet jingħata lill-kelb darba kuljum, flimkien ma' l-ikel, f'doża ta' 0.2mg/kg fl-ewwel jum, u b'doża ta' 0.1mg għall-ġranet ta' wara.
English: A study looked at how Meloxivet was absorbed and its effects in the body, in comparison with Metacam 1.5 mg/ml oral suspension.
Maltese: Sar studju li ħares lejn kif Meloxivet ġiet assorbita u l-effetti tagħha fil-ġisem, meta mqabbla ma' 1.5mg/ml ta' sospensjoni orali Metacam.
English: How does Meloxivet work?
Maltese: Għalxiex tintuża Meloxivet?
English: People who are hypersensitive (allergic) to NSAIDs should avoid contact with Meloxivet.
Maltese: Il-persuni li huma allerġiċi għall-NSAIDs għandhom jevitaw il-kuntatt ma' Meloxivet.
English: Studies have been carried out to prove that Meloxivet is ‘bioequivalent' to the reference veterinary medicine: this means that Meloxivet is equivalent to Metacam 1.5 mg/ml suspension in the way it is absorbed and used by the body.
Maltese: Dan ifisser li Meloxivet huwa ekwivalenti għal Metacam 1.5mg/ml ta' sospensjoni filmod ta' kif tiġi assorbita u wżata mill-ġisem.
English: Invented name Strength Pharmaceutical Form Route of administration
Maltese: Għamla farmaċewtika
English: EU/1/16/1102/001 Bortezomib SUN 3.5 mg Powder for solution for injection Intravenous use, Subcutaneous use vial (glass)
Maltese: EU/1/16/1102/001 Bortezomib SUN 3,5 mg Trab għal soluzzjoni għallinjezzjoni
English: 1 vial
Maltese: 1 kunjett wieħed
English: Intravenous use vial (glass) concentrate: 1.2 ml; solvent: 1.8 ml
Maltese: 1.2 ml; solvent: 1.8 ml
English: 30 mg Concentrate and solvent for solution for infusion
Maltese: 30 mg Konċentrat u solvent għal soluzzjoni għall infużjoni
English: 4 March 2019
Maltese: 4 ta' Marzu 2019
English: November 2018 CMDh meeting
Maltese: Laqgħa tas-CMDh Novembru 2018
English: 3 January 2019
Maltese: 3 ta' Jannar 2019
English: As part of the initial MA procedure (FR/H/511/01/DC), the MAH Ipsen Pharma committed to conduct a DUS to assess drug utilisation in the real life setting in a representative sample of the European target population.
Maltese: Bħala parti mill-proċedura inizjali tal-MA (FR/H/511/01/DC), il-MAH Ipsen Pharma ikkommettiet ruħha li twettaq DUS biex tivvaluta l-użu tad-drogi f'ambjent reali f'kampjun rappreżentattiv tal-popolazzjoni fil-mira Ewropea.
English: The final study report has been endorsed by the PRAC, and the related condition of the marketing authorisation has been fulfilled.
Maltese: Ir-rapport finali ta' studju ġie approvat mill-PRAC, u l-kondizzjoni relatata tal-awtorizzazzjoni ta' tqegħid fis-suq twettqet.
English: Transmission to National Competent Authorities of the translations of the annexes to the position:
Maltese: Trażmissjoni lill-Awtoritajiet Nazzjonali Kompetenti tat-traduzzjonijiet tal-annessi għall-pożizzjoni:
English: Taking into account the PRAC Assessment Report for the non-interventional imposed PASS final report for the medicinal product(s) containing the active substance magnesium sulphate heptahydrate, sodium sulphate anhydrous, potassium sulphate and concerned by the PASS final report , the scientific conclusions are as follows:
Maltese: Meta jiġi kkunsidrat ir-Rapport ta' Valutazzjoni tal-PRAC għar-rappport finali ta' studju dwar issikurezza wara l-awtorizzazzjoni (PASS) impost mingħajr intervent għall-prodott(i) mediċinali li fih(om) is-sustanza attiva sulfat tal-magneżju ettaidrat, sulfat tal-anidrożju, sulfat tal-potassju u li huma kkonċernati mir-rapport finali ta' PASS, il-konklużjonijiet xjentifiċi huma kif ġej:
English: Implementation of the position by the Member States (submission of the variation by the Marketing Authorisation Holder):
Maltese: Implimentazzjoni tal-pożizzjoni mill-Istati Membri (sottomissjoni tal-varjazzjoni mid-Detentur talAwtorizzazzjoni għat-Tqegħid fis-Suq):
English: Changes to be made to the conditions of the marketing authorisation(s) of medicinal product(s) containing the active substance magnesium sulphate heptahydrate, sodium sulphate anhydrous, potassium sulphate concerned by the non-interventional imposed PASS final report
Maltese: It-tibdil li għandu jsir fil-kundizzjonijiet tal-awtorizzazzjoni(jiet) għat-tqegħid fis-suq ta' prodott(i) mediċinali li fih(om) is-sustanza attiva sulfat tal-magneżju ettaidrat, sulfat talanidrożju, sulfat tal-potassju u li huwa kkonċernat mir-rapport finali ta' PASS impost mingħajr intervent
English: On the basis of the scientific conclusions for the results of the study for the medicinal product(s) containing the active substance magnesium sulphate heptahydrate, sodium sulphate anhydrous, potassium sulphate and concerned by the PASS final report , the CMDh is of the opinion that the benefit-risk balance of the medicinal product(s) mentioned above is unchanged subject to the proposed changes to the product information.
Maltese: Abbażi tal-konklużjonijiet xjentifiċi għar-riżultati tal-istudju għall-prodott(i) mediċinali li fih(om) issustanza attiva sulfat tal-magneżju ettaidrat, sulfat tal-anidrożju, sulfat tal-potassju u li huwa kkonċernat mir-rapport finali ta' PASS, is-CMDh huwa tal-fehma li l-bilanċ bejn il-benefiċċju u r-riskju tal-prodott(i) mediċinali msemmi(ja) hawn fuq mhuwiex mibdul suġġett għall-bidliet proposti għallinformazzjoni tal-prodott.
English: Annex II Conditions of Marketing Authorisation
Maltese: Anness II
English: The applicant will submit a draft study protocol within 3 months after approval, in Q2 2013 in order to be ready at the time of product launch in 2014.
Maltese: L-applikant ser jissottometti abbozz ta' protokoll ta' studju fi żmien 3 xhur wara l-approvazzjoni, fittieni kwart tal-2013 biex ikun lest fil-mument tat-tnedija tal-prodott fl-2014.
English: Sandimmun Neoral soft capsules contain 11.8% v/v ethanol (9.4% m/v).
Maltese: Sandimmun Neoral kapsuli rotob fihom 11.8% v/v ethanol (9.4% m/v).
English: Sandimmun Neoral oral solution contains 12% v/v ethanol (9.5% m/v).
Maltese: Is-soluzzjoni orali Sandimmun Neoral fiha 12% v/v ethanol (9.5% m/v).
English: Sandimmun Neoral 100 mg/ml oral solution ciclosporin
Maltese: Sandimmun Neoral 100 mg/ml soluzzjoni orali ciclosporin
English: A jelly-like formation may occur below 20°C, which is however reversible at temperatures up to 30°C.
Maltese: Tista' tifforma formazzjoni li tixbah il-jelly taħt l-20°C, li madanakollu hi riversibbli f'temperaturi sa 30°C.
English: Haemolytic uraemic syndrome, microangiopathic haemolytic anaemia
Maltese: Sindrome emolitiku-uremika, anemija emolitika mikroanġjopatika
English: Sandimmun Neoral contains around 12% vol. ethanol.
Maltese: Sandimmun Neoral fih madwar 12% vol. ethanol.
English: In plasma, approximately 90% is bound to proteins, mostly lipoproteins.
Maltese: Fil-plasma, madwar 90% jeħel mal-proteini, l-aktar mal lipoproteini.
English: Hyperglycaemia, anorexia, hyperuricaemia, hyperkalaemia, hypomagnesaemia Nervous system disorders
Maltese: Ipergliċemija, anoressija, iperurikemija, iperkalemija, ipomagneżemija Disturbi fis-sistema nervuża
English: Subsequent use Commence at point 5.
Maltese: Ibda minn punt 5.
English: Solid organ transplantation
Maltese: Trapjant ta' organu solidu
English: Monitoring ciclosporin levels (see section 4.2)
Maltese: Monitoraġġ tal-livelli ta' ciclosporin (ara sezzjoni 4.2)
English: Sandimmun Neoral is indicated in patients with severe atopic dermatitis when systemic therapy is required.
Maltese: Sandimmun Neoral hu indikat għal pazjenti b'dermatite atopika gravi meta tenħtieġa terapija sistemika.
English: The intersubject and intrasubject variability for AUC and Cmax is approximately 10-20%.
Maltese: Ilvarjabbiltà intrasuġġetali u intrasuġġettali għal AUC u Cmax hi ta' madwar 10-20%.
English: Co-administration of ciclosporin with bosentan is not recommended (see above subsection “Drugs that decrease ciclosporin levels” and section 4.3).
Maltese: ciclosporin ma' bosentan mhuwiex irrakkomandat (ara s-sottosezzjoni “Mediċini li jnaqqsu l-livelli ta' ciclosporin” u sezzjoni 4.3).