FrancophonIA/ELRC3.0 huggingface dataset:
English: The CHMP therefore decided that Neofordex's benefits are greater than its risks and recommended that it be approved for use in the EU.
Maltese: Is-CHMP għaldaqstant iddeċieda li l-benefiċċji ta' Neofordex huma akbar mir-riskji tiegħu u rrakkomanda li jiġi approvat għall-użu fl-UE.
English: In multiple myeloma, Neofordex is used together with cancer medicines to kill cancerous plasma cells.
Maltese: F'majeloma multipla, Neofordex jintuża flimkien ma' mediċini kontra l-kanċer biex joqtol ċelloli tal-plażma kanċeroġeni.
English: Multiple myeloma is a cancer of a type of white blood cell called plasma cells, which are part of the immune system (the body's natural defences).
Maltese: Majeloma multipla hija kanċer ta' tip ta' ċelloli bojod tad-demm li jissejħu ċelloli tal-plażma, li huma parti mis-sistema immunitarja (id-difiżi naturali tal-ġisem).
English: For the full list of all side effects reported with Neofordex, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrappurtati b'Neofordex, ara l-fuljett ta' tagħrif.
English: Neofordex may also reduce certain side effects of cancer treatment, such as nausea (feeling sick) and vomiting.
Maltese: Neofordex jista' wkoll inaqqas ċerti effetti sekondarji tal-kura tal-kanċer, bħal dardir (tħossok ma tiflaħx) jew rimettar.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that Neofordex has been shown to have comparable quality to Dectancyl and the use of high-dose dexamethasone in multiple meyloma is well established.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-bniedem tal-Aġenzija (CHMP) ikkonkluda li Neofordex wera li għandu kwalità komparabbli għal Dectancyl u l-użu ta' dexamethasone b'doża għolja f'majeloma multipla huwa stabbilit sew.
English: It is not intended to provide practical advice on how to use Neofordex.
Maltese: Dan mhux maħsub biex jipprovdi konsultazzjoni prattika dwar l-użu ta' Neofordex.
English: How does Neofordex work?
Maltese: X'inhu Neofordex u għal xiex jintuża?
English: EMA/664784/2012 EMEA/H/C/000882
Maltese: EMEA/H/C/000882
English: It is available as capsules (250 mg) and tablets (500 mg).
Maltese: Huwa disponibbli f'forma ta' pilloli (250 mg) u tal-(500 mg).
English: The full EPAR for Mycophenolate mofetil Teva can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: L-EPAR sħiħ għal Mycophenolate mofetil Teva jinstab fis-sit elettroniku tal-Aġenzija: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: For kidney transplants, the recommended dose in adults is 1.0 g twice a day starting within 72 hours after the transplant.
Maltese: Għat-trapjanti tal-kliewi, id-doża rakkomandata fl-adulti hija 1.0 g darbtejn kuljum li għandha tinbeda 72 siegħa wara t-trapjant.
English: Mycophenolate mofetil Teva mycophenolate mofetil
Maltese: Mycophenolate mofetil Teva mikofonelat mofetil (mycophenolate mofetil)
English: The active substance in Mycophenolate mofetil Teva, mycophenolate mofetil, is an immunosuppressive medicine.
Maltese: Is-sustanza attiva f'Mycophenolate mofetil Teva, mikofonelat mofetil, hija mediċina immunosuppressiva.
English: Mycophenolate mofetil Teva is a ‘generic medicine'.
Maltese: Mycophenolate mofetil Teva huwa ‘mediċina ġenerika'.
English: In the body, it is converted into mycophenolic acid, which blocks an enzyme called ‘inosine monophosphate dehydrogenase'.
Maltese: Fil-ġisem, tinbidel f'aċidu mikofenoliku, li jimblokka enzima magħrufa bħala ‘inosina monofosfat deidrogenażi' (inosine monophosphate dehydrogenase).
English: For liver transplants in adults, mycophenolate mofetil should be given as an infusion (drip into a vein) for the first four days after the transplant, before the patient is switched to 1.5 g Mycophenolate mofetil Teva twice a day as soon as it can be tolerated.
Maltese: F'każ ta' trapjanti tal-fwied f'adulti, mikofonelat mofetil għandu jingħata bħala infużjoni (bid-dripp filvina) għall-ewwel erbat ijiem wara t-trapjant, qabel ma' l-pazjent tinbidillu d-doża għal 1.5 g ta' Mycophenolate mofetil Teva darbtejn kuljum hekk kif din tista' tiġi aċċettata mill-pazjent.
English: This is a summary of the European public assessment report (EPAR) for Mycophenolate mofetil Teva.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Mycophenolate mofetil Teva.
English: Because Mycophenolate mofetil Teva is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, CellCept.
Maltese: Billi Mycophenolate mofetil Teva huwa mediċina ġenerika, l-istudji ġew limitati għal testitjiet li jiddeterminaw il-bijoekwivalenza tiegħu mal-mediċina ta' referenza CellCept.
English: For heart transplants, the recommended adult dose is 1.5 g twice a day, starting within five days following the transplant.
Maltese: Għat-trapjanti tal-qalb, id-doża rakkomandata għall-adulti hija ta' 1.5 g darbtejn kuljum, li tinbeda fi żmien ħamest ijiem mit-trapjant.
English: The CHMP concluded that, in accordance with EU requirements, Mycophenolate mofetil Teva has been shown to have comparable quality and to be bioequivalent to CellCept.
Maltese: Is-CHMP ikkonkluda li, skont ir-rekwiżiti tal-UE, intwera li Mycophenolate mofetil Teva għandu kwalità li tixbah lill-prodott mediċinali bijoekwivalenti għal CellCept.
English: This means that Mycophenolate mofetil Teva is similar to a ‘reference medicine' already authorised in the European Union (EU) called CellCept.
Maltese: Dan ifisser li Mycophenolate Mofetil Teva huwa simili għall-‘mediċina ta' referenza' diġà awtorizzata fl-Unjoni Europea (UE) li jisimha CellCept.
English: It is used with ciclosporin and corticosteroids (other medicines used to prevent organ rejection).
Maltese: Jintuża maċ-ċiklosporina u l-kortikosterojdi (mediċini oħra biex jipprevjenu r-riġettar tal-organi).
English: Mycophenolate mofetil Teva is a medicine containing the active substance mycophenolate mofetil.
Maltese: Mycophenolate Mofetil Teva huwa mediċina li fiha s-sustanza attiva mikofonelat mofetil.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Mycophenolate mofetil Teva on 21 February 2008.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Mycophenolate mofetil Teva valida fl-Unjoni Ewropea kollha fil-21 ta' Frar 2008.
English: Other information about Mycophenolate mofetil Teva
Maltese: Aktar informazzjoni dwar Mycophenolate mofetil Teva
English: What is Mycophenolate mofetil Teva?
Maltese: X'inhu Mycophenolate Mofetil Teva?
English: The full EPAR for the reference medicine can also be found on the EMEA's website.
Maltese: L-EPAR sħiħ għall-mediċina ta' referenza jista' jinstab ukoll fuq is-sit tal-internet tal-EMA.
English: The way that Mycophenolate mofetil Teva should be given and the dose depend on the type of organ transplant and the patient's age and size.
Maltese: Il-mod ta' kif Mycophenolate Mofetil Teva għandu jingħata u d-doża jiddependu mit-tip ta' organu li jiġi trapjantat, l-età u d-daqs tal-pazjent.
English: Because Mycophenolate mofetil Teva is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Maltese: Peress li Mycophenolate mofetil Teva huwa mediċina ġenerika u huwa bijoekwivalenti għall-mediċina ta' referenza, jitqies li l-benefiċċji u r-riskji tiegħu huma l-istess bħal dawk tal-mediċina ta' referenza.
English: For more information, see the summary of product characteristics (also part of the EPAR).
Maltese: Għal aktar informazzjoni, ara s-sommarju tal-karatteristiċi tal-prodott (huwa parti wkoll mill-EPAR).
English: Pregabalin Sandoz is available as capsules (25, 50, 75, 100, 150, 200, 225 and 300 mg) and can only be obtained with a prescription.
Maltese: Pregabalin Sandoz jiġi bħala kapsuli (25, 50, 75, 100, 150, 200, 225 u 300 mg) u jista' jinkiseb biss b'riċetta ta' tabib.
English: The maximum dose is 600 mg per day.
Maltese: Id-doża massima hija ta' 600 mg kuljum.
English: • generalised anxiety disorder (long-term anxiety or nervousness about everyday matters).
Maltese: • disturb tal-ansjetà ġeneralizzat (ansjetà u nervi fit-tul dwar ħwejjeġ ta' kuljum).
English: The full EPAR and risk management plan summary for Pregabalin Sandoz can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: L-EPAR sħiħ u s-sommarju tal-pjan tal-ġestjoni tar-riskju għal Pregabalin Sandoz jinstabu fis-sit elettroniku tal-Aġenzija: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Pregabalin Sandoz is a ‘generic medicine'.
Maltese: Pregabalin Sandoz huwa ‘mediċina ġenerika'.
English: The active substance in Pregabalin Sandoz, pregabalin, is similar in structure to the body's own ‘neurotransmitter' gamma‑amino butyric acid (GABA), but has very different biological effects.
Maltese: Is-sustanza attiva f'Pregabalin Sandoz, pregabalin, hija simili fl-istruttura għall-aċidu butriku talgamma-amino (GABA) ‘newrotrażmettitur' tal-ġisem stess, iżda għandha effetti bijoloġiċi differenti ħafna.
English: This is a summary of the European public assessment report (EPAR) for Pregabalin Sandoz.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Pregabalin Sandoz.
English: • neuropathic pain (pain due to nerve damage), including peripheral neuropathic pain, such as the pain experienced by patients with diabetes or herpes zoster (shingles), and central neuropathic pain, such as the pain experienced by patients who have had a spinal cord injury;
Maltese: • uġigħ newropatiku (uġigħ dovut għal ħsara fin-nervituri) inkluż uġigħ newropatiku periferiku, bħal uġigħ esperjenzat minn pazjenti b'dijabete jew li għandhom il-herpes zoster (ħruq ta' Sant'Antnin), u uġigħ newropatiku ċentrali, bħalma huwa uġigħ esperjenzat minn pazjenti li kellhom ħsara filmudullun tas-sinsla tad-dahar;
English: Pregabalin Sandoz pregabalin
Maltese: Informazzjoni oħra dwar Pregabalin Sandoz
English: Pregabalin Sandoz contains the active substance pregabalin.
Maltese: Pregabalin Sandoz fih is-sustanza attiva pregabalin.
English: After three to seven days, the dose can be increased to 300 mg per day.
Maltese: Wara tlett ijiem sa sebat ijiem, id-doża tista' tiżdied għal 300 mg kuljum.
English: Neurotransmitters are chemicals that allow nerve cells to communicate with each other.
Maltese: In-newrotrasmettituri huma sustanzi kimiċi li jippermettu liċ-ċelloli tan-nervituri jikkomunikaw ma' xulxin.
English: Because Pregabalin Sandoz is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Lyrica.
Maltese: Billi Pregabalin Sandoz huwa mediċina ġenerika, l-istudji fuq in-nies ġew limitati għal testijiet biex jiddeterminaw il-bijoekwivalenza tiegħu mal-mediċina ta' referenza, Lyrica.
English: The recommended starting dose is 150 mg per day, divided into two or three doses.
Maltese: Id-doża rakkomandata inizjali hija ta' 150 mg kuljum, maqsuma f'żewġ jew tliet dożi.
English: • epilepsy, where it is used as an ‘add-on' to existing treatment in patients who have partial seizures (epileptic fits starting in one specific part of the brain) that cannot be controlled with their current treatment;
Maltese: • epilessija, fejn jintuża bħala ‘żieda' flimkien ma' kura eżistenti f'pazjenti li jbatu minn aċċessjoni parzjali (epilessija severa li tibda f'parti speċifika tal-moħħ) li ma tistax tiġi kkontrollata bil-kura li qed jieħdu fil-preżent;
English: Why is Pregabalin Sandoz approved?
Maltese: Għaliex ġie approvat Pregabalin Sandoz?
English: Because Pregabalin Sandoz is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Maltese: Minħabba li Pregabalin Sandoz huwa mediċina ġenerika u bijoekwivalenti għall-mediċina ta' referenza, il-benefiċċji u r-riskji tiegħu jitqiesu l-istess bħal dawk tal-mediċina ta' referenza.
English: This means that Pregabalin Sandoz is similar to a ‘reference medicine' already authorised in the European Union (EU) called Lyrica.
Maltese: Dan ifisser li Pregabalin Sandoz jixbah lill-‘mediċina ta' referenza' diġà awtorizzata fl-Unjoni Ewropea (UE) magħrufa bħala Lyrica.
English: The Committee recommended that Pregabalin Sandoz be approved for use in the EU.
Maltese: Il-Kumitat irrakkomanda li Pregabalin Sandoz ikun approvat għall-użu fl-UE.
English: Pregabalin Sandoz is a medicine used to treat adults with the following conditions:
Maltese: Pregabalin Sandoz huwa mediċina li tintuża għat-trattament ta' adulti bil-kundizzjonijiet li ġejjin:
English: How has Pregabalin Sandoz been studied?
Maltese: Kif ġie studjat Pregabalin Sandoz?
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Pregabalin Sandoz has been shown to have comparable quality and to be bioequivalent to Lyrica.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (is-CHMP) tal-Aġenzija kkonkluda li, skont ir-rekwiżiti tal-UE, intwera li Pregabalin Sandoz għandu kwalità komparabbli u huwa bijoekwivalenti għal Lyrica.
English: A risk management plan has been developed to ensure that Pregabalin Sandoz is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Pregabalin Sandoz jintuża bl-aktar mod sikur possibbli.
English: What are the benefits and risks of Pregabalin Sandoz?
Maltese: X'inhuma l-benefiċċji u r-riskji ta' Pregabalin Sandoz?
English: How is Pregabalin Sandoz used?
Maltese: Kif jaħdem Pregabalin Sandoz?
English: This reduces the activity of some of the nerve cells in the brain and spinal cord, reducing the release of other neurotransmitters that are involved in pain, epilepsy and anxiety.
Maltese: Dan inaqqas l-attività ta' xi ċelluli tannervituri fil-moħħ u fil-mudullun tas-sinsla tad-dahar, billi jnaqqas ir-rilaxx ta' newrotrażmettituri oħrajn li huma involuti fl-uġigħ, l-epilessija u l-ansjetà.
English: Therefore, the CHMP's view was that, as for Lyrica, the benefit outweighs the identified risk.
Maltese: Għaldaqstant, il-fehma tas-CHMP kienet li, bħal fil-każ ta' Lyrica, il-benefiċċji huma akbar mir-riskji identifikati.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Pregabalin Sandoz on 19 June 2015.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Pregabalin Sandoz valida madwar l-Unjoni Ewropea kollha fid-19 ta' Ġunju 2015.
English: The full EPAR for the reference medicine can also be found on the Agency's website.
Maltese: L-EPAR sħiħ u għall-mediċina ta' referenza jinstabu fis-sit web tal-Aġenzija.
English: It is not intended to provide practical advice on how to use Pregabalin Sandoz.
Maltese: Dan mhux intiż biex jipprovdi konsultazzjoni prattika dwar l-użu ta' Pregabalin Sandoz.
English: How does Pregabalin Sandoz work?
Maltese: Kif jintuża Pregabalin Sandoz?
English: 200 mg Concentrate for solution for infusion
Maltese: 200 mg Konċentrat għal soluzzjoni għal infużjoni
English: 20ml (10 mg/ml) 3 vials
Maltese: Użu għal ġol-vini kunjett (ħġieġ) 20ml (10 mg/ml) 3 kunjetti
English: ΕΛΕΓΧOΜΕΝΗΣ ΑΠΟΔEΣΜΕΥΣΗΣ
Maltese: ΕΛΕΓΧOΜΕΝΗΣ
English: ACTAVIS GROUP HF.
Maltese: Id-Danimarka ACTAVIS GROUP HF.
English: LIBERTAÇÃO
Maltese: ОСВОБОЖДАВАНЕ
English: COMPRIMIDOS DE
Maltese: MG TABLETTE
English: HEALTHCARE, PRODUTOS PARA A SAÚDE E HIGIENE, LDA
Maltese: GLAXOSMITHKLINE CONSUMER HEALTHCARE, PRODUTOS PARA A SAÚDE E HIGIENE, LDA
English: PARATABS RETARD PARACETAMOL 500MG TABLET
Maltese: PARATABS RETARD PARAĊETAMOL PILLOLA TA' 500MG
English: PANADOL EXTEND 665 MG ΔΙΣΚΙΑ
Maltese: PANADOL EXTEND 665
English: PARACETAMOL 650MG TABLET, TRAMADOL 75MG TABLET
Maltese: PARAĊETAMOL PILLOLA TA' 650MG, TRAMADOL PILLOLA TA' 75MG
English: PANADOL EXTEND 665 MG TABLETT MED MODIFIERAD FRISÄTTNING PARACETAMOL
Maltese: MG TABLETT MED MODIFIERAD FRISÄTTNING PARACETAMOL
English: FORÐATÖFLUR
Maltese: UVOLNOVANÍM
English: PANADOL EXTEND 665 MG SÄÄDELLYSTI VAPAUTTAVA TABLETTI
Maltese: MG SÄÄDELLYSTI VAPAUTTAVA TABLETTI
English: DORETA, 75 MG/650
Maltese: DORETA SR, 75 MG + 650
English: PANADOL RETARD 8 UUR, 665 MG TABLET MET GEREGULEERDE AFGIFTE
Maltese: PANADOL RETARD 8 UUR, 665
English: ALVEDON 665 MG TABLETT MED MODIFIERAD FRISÄTTNING
Maltese: MG TABLETT MED MODIFIERAD FRISÄTTNING
English: PANADOL ARTRO 665 MG COMPRIMATE CU ELIBERARE PRELUNGITĂ
Maltese: MG COMPRIMATE CU ELIBERARE PRELUNGITĂ
English: PROLONGADA
Maltese: MODIFIÉE
English: DORETA PROLONG 75 MG/650 MG TABLETY S PRODLOUŽENÝM UVOLŇOVÁNÍM
Maltese: DORETA PROLONG 75 MG/650 MG TABLETY S PRODLOUŽENÝM
English: MG TOIMEAINET PROLONGEERITULT VABASTAVAD TABLETID
Maltese: MG, COMPRIMIDOS DE LIBERTAÇÃO PROLONGADA
English: DORETA SR 75 MG/650 MG TABLETY S PREDLŽENÝM UVOLNOVANÍM
Maltese: DORETA SR 75 MG/650 MG TABLETY S PREDLŽENÝM
English: DORETA 75 MG/650 MG ILGSTOŠĀS DARBĪBAS TABLETES
Maltese: MG/650 MG ILGSTOŠĀS DARBĪBAS TABLETES
English: PANADOL EXTEND 665 MG, TABLETTEN MET GEREGULEERDE AFGIFTE
Maltese: MG, TABLETTEN MET GEREGULEERDE AFGIFTE
English: DORETA 75 MG/650 MG PAILGINTO
Maltese: MG/650 MG PAILGINTO
English: ДОРЕТА SR 75 MG/650 MG ТАБЛЕТКИ С УДЪЛЖЕНО ОСВОБОЖДАВАНЕ
Maltese: SR 75 MG/650 MG ТАБЛЕТКИ С УДЪЛЖЕНО
English: • Prophylaxis of migraine headache
Maltese: • Profilassi tal-uġigħ ta' ras minn emigranja
English: • Symptomatic treatment of veno-lymphatic insufficiency All references to the above mentioned indications should be deleted from the remaining relevant sections of the summaries of product characteristics.
Maltese: Ir-referenzi kollha għall-indikazzjonijiet imsemmija hawn fuq għandhom jitneħħew mis-sezzjonijiet relevanti li jibqa' tas-sommarji tal-karatteristiċi tal-prodott.
English: [the below currently approved indications should be deleted (specific wording of the indication may vary from product to product)]
Maltese: [l-indikazzjonijiet approvati attwalment hawn taħt għandhom jitneħħew (il-formolazzjoni tal-kliem speċifika tal-indikazzjoni tista' tvarja minn prodott għal prodott)]
English: the MAHs should identify a patient population for which the benefit risk ratio of tetrazepam containing medicines is positive on the basis of scientifically relevant supportive data.
Maltese: il-MAHs għandhom jidentifikaw popolazzjoni ta' pazjenti li għalihom il-proporzjon tal-benefiċċju u tar-riskju ta' mediċini li fihom it-tetrażepam jkun pożittiv u appoġġjat b'dejta xjentifikament rilevanti.
English: Annex III Conditions for lifting the suspension of the marketing authorisations
Maltese: Anness III Kondizzjonijiet għat-tneħħija tas-sospensjoni tal-awtorizzazzjonijiet għat-tqegħid fis-suq
English: For the suspension to be lifted, the National competent authorities of Member States shall verify that the following conditions are fulfilled by the MAHs:
Maltese: Biex is-sospensjoni titneħħa, l-awtoritajiet Nazzjonali kompetenti tal-Istati Membri għandhom jivverifikaw li d-detenturi tal-awtorizzazzjoni għat-tqegħid fis-suq (MAH)s jissodisfaw l-kundizzjonijiet li ġejjin:
English: Conditions for lifting the suspension of the marketing authorisations
Maltese: Kundizzjonijiet għat-tneħħija tas-sospensjoni tal-awtorizzazzjonijiet għattqegħid fis-suq
English: Frequency and route of administration
Maltese: Frekwenza u mod ta' amministrazzjoni
English: 500 mg
Maltese: 500mg Żwiemel
English: Tiludronate belongs to the biphosphonates family.
Maltese: Tiludronate jappartjeni għall-familja tal-biphosphonates.
English: Tildren 500 mg lyophilisate for solution for infusion
Maltese: Tildren 500 mg lyophilisate għal soluzzjoni għal infużjoni
English: 1 mg/kg body weight (5 ml reconstituted solution per 100 kg)
Maltese: 1 mg/kg piż korporali (5 ml soluzzjoni rikostitwita għal kull 100 kg)
English: The dose of 1 mg/kg was selected as the dose producing approximately 75 % inhibition of bone resorption.
Maltese: Id-doża ta' 1 mg/kg intgħażlet bħala d-doża li tipproduċi madwar 75 % inibizzjoni ta' risorbiment tal-għadam.
English: Assessment of the efficacy of Tildren
Maltese: Valutazzjoni tal-effikaċja ta' Tildren
English: Recommended dose
Maltese: Doża rrakkomandata
English: Tiludronate has anti-inflammatory and anti-arthritic properties by acting on macrophages.
Maltese: Tiludronate għandu kwalitajiet anti-infjammatorji u anti-artrite billi jaġixxi fuq il-makrofaġi.
English: List of the name, pharmaceutical form, strength of the veterinary medicinal product, animal species, route(s) of administration, marketing authorisation holder in the member states
Maltese: Lista tal-isem, għamla farmaċewtika, qawwa tal-prodott mediċinali veterinarju, speċi li fuqhom għandu jintuża lprodott, mod ta' amministrazzjoni, detentur talawtorizzazzjoni għat-tqegħid fis-suq fl-istati membri
English: TILDREN 500 mg, lyophilisate for solution for infusion (Tiludronic acid) is a product indicated as an aid in the treatment of clinical signs of lameness associated with bone spavin in combination with a controlled exercise regime in horses over 3 years of age.
Maltese: TILDREN 500 mg, lyophilisate għal soluzzjoni għal infużjoni (Tiludronic acid) huwa prodott indikat bħala għajnuna fil-kura ta' sinjali kliniċi ta' zappip assoċjat ma' bone spavin flimkien ma' reġim ta' eżerċizzju kkontrollat fiż-żwiemel ta' età ta' aktar minn 3 snin.
English: Bone spavin is a degenerative joint disease, characterized by bone modelling changes, articular cartilage destruction, and marginal osteophyte formation.
Maltese: Bone spavin hija marda tal-ġogi deġenerattiva, ikkaratterizzata minn bidliet fl-iffurmar tal-għadam, distruzzjoni tal-kartilaġni artikolari, u formazzjoni ta' osteofiti marġinali.
English: These enzymes are responsible for the degradation of the joint cartilage matrix.
Maltese: Dawn l-enzimi huma responsabbli għad-degradazzjoni tal-matriċi tal-kartilaġni tal-ġogi.
English: The second clinical study was performed in accordance with GCP to assess the efficacy and the safety of tiludronic acid administered as a single infusion at the dose of 1 mg/kg bw in the treatment of bone spavin in horses.
Maltese: It-tieni prova klinika twettqet skont il-GCP biex jiġu vvalutati l-effikaċja u s-sigurtà ta' tiludronic acid li jingħata bħala infużjoni waħda bid-doża ta' 1 mg/kg bw fit-trattament ta' bone spavin fiżżwiemel.
English: Tiludronate is incorporated into the bone matrix and the osteoclasts where it affects ATP-dependent intracellular enzymes leading to apoptosis.
Maltese: Tiludronate huwa inkorporat fil-matriċi tal-għadam u fl-osteoklasti fejn jaffettwa enzimi intraċellulari li jiddependu fuq ATP u jwassal għall-apoptożi.
English: Condition for the lifting of the suspension
Maltese: Kundizzjoni għat-tneħħija tas-sospensjoni
English: They considered that the selected dose was shown to produce concentrations in bone that are in the range of concentrations shown to inhibit bone resorption in vitro systems and that PK/PD modelling used was adequate to derive a pharmacologically active dose using a marker of bone resorption.
Maltese: Huma kkunsidraw li d-doża magħżula wriet li tipproduċi konċentrazzjonijiet fl-għadam li huma fil-firxa ta' konċentrazzjonijiet li wrew li jimpedixxu rrisorbiment tal-għadam f'sistemi in vitro u li l-immudellar PK/PD li ntuża ma kienx adegwat biex titnissel doża farmakoloġikament attiva bl-użu ta' markatur tar-risorbiment tal-għadam.
English: With regard to the concomitant NSAID treatment, the MAH concluded there were no statistical differences between the treated and placebo groups having received NSAID treatment and therefore had not included this treatment in the statistical analysis.
Maltese: Fir-rigward tat-trattament NSAID konkomittanti, il-MAH ikkonkluda li ma kien hemm l-ebda differenza statistika bejn il-grupp trattat u dak tal-plaċebo li rċievew trattament NSAID u għalhekk ma nkludiex dan it-trattament fl-analiżi statistika.
English: Overall summary of the scientific evaluation of TILDREN 500 mg lyophilisate for solution for infusion
Maltese: Sommarju ġenerali tal-evalwazzjoni xjentifika ta' TILDREN 500 mg lyophilisate għal soluzzjoni għall-infużjoni