FrancophonIA/ELRC3.0 huggingface dataset:
English: Very limited data on pregnancies exposed to Glybera is available.
Maltese: Id-dejta dwar tqaliet esposti għal Glybera hija limitata ħafna.
English: Burning sensation, Dizziness, Formication, Presyncope
Maltese: Formikazzjoni, Presinkope
English: OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING Pharmacovigilance system
Maltese: Sistema ta' Farmakoviġilanza
English: Product manufacturer and license holder: uniQure biopharma B.V.
Maltese: Manifattur tal-prodott u d-detentur tal-liċenzja: uniQure biopharma B.V.
English: People who are affected by this condition have a build up of very high fat levels in their blood (hyperchylomicronemia).
Maltese: Persuni li huma affettwati minn din il-kundizzjoni għandhom akkumulazzjoni ta' livelli għoljin ħafna ta' xaħam fid-demm tagħhom (hyperchylomicronemia).
English: Each patient-specific pack contains a sufficient amount of vials to dose each patient with 1 x 1012 LPLS447X gc/kg bodyweight.
Maltese: Kull pakkett speċifiku għall-pazjent fih ammont suffiċjenti ta' kunjetti biex jagħti doża ta' 1 x 1012 LPLS447X gc/kg tal-piż tal-ġisem lil kull pazjent.
English: • Information on the treatment procedure with Glybera
Maltese: • Informazzjoni dwar il-proċedura ta' kura bi Glybera
English: The first 2 patients enrolled received a dose of 3 x 1011 gc/kg, the next 4 patients received a dose of 3 x 1011 gc/kg with immunosuppressant regiment (oral ciclosporin and oral mycophenolate mofetil from the day after Glybera administration until Week 12) and the final 8 patients received a dose of 1 x 1012gc/kg with immunosuppressant regiment.
Maltese: l-4 pazjenti ta' wara rċevew doża ta' 3 x 1011 gc/kg b'kors ta' immunosoppressanti (ciclosporin orali u mycophenolate mofetil orali mill-ġurnata wara l-għoti ta' Glybera sa Ġimgħa 12) u l-aħħar 8 pazjenti rċevew doża ta' 1 x 1012gc/kg b'kors ta' immunosoppressanti.
English: • Information on the need for long term follow-up for Glybera, including the registry
Maltese: • Informazzjoni dwar il-ħtieġa ta' segwitu fit-tul għal Glybera, inkluż ir-reġistru
English: - Educational materials for health care professionals
Maltese: - Materjal edukattiv għall-pazjenti
English: Potassium dihydrogen phosphate Sodium chloride
Maltese: Potassium chloride Potassium dihydrogen phosphate Sodium chloride Disodium phosphate Sucrose Ilma għall-injezzjonijiet
English: The biodistribution pattern was very similar in the other tested species (cats and rabbits).
Maltese: Id-disinn ta' bijodistribuzzjoni kien simili ħafna fl-ispeċi loħra ttestjati (qtates u fniek).
English: Clinical trial CT-AMT-010-01
Maltese: Prova klinika CT-AMT-010-01
English: The patient's weight should be divided by 3, then without rounding up this number multiplied by 2 and rounded up to the next higher whole number.
Maltese: Il-piż tal-pazjent għandu jiġi diviż bi 3, imbagħad mingħajr ma dan in-numru jiġi mqarreb għall-eqreb numru sħiħ, jiġi multiplikat bi 2 u mqarreb sal-eqreb ogħla numru sħiħ.
English: Glybera 3 × 1012 genome copies/ml solution for injection
Maltese: Glybera 3 × 1012 kopji tal-genoma/ml soluzzjoni għal injezzjoni
English: 3) Educational materials for patients treated with Glybera including the following key safety elements:
Maltese: 1) Materjal edukattiv għall-Ispiżjara inkluż l-elementi ewlenin li ġejjin dwar is-sigurtà:
English: • Hypersensitivity to the active substance or any of the excipients of Glybera listed in section
Maltese: • Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe wieћed mill-eċċipjenti ta'
English: • pain in leg(s) (pain in extremity)
Maltese: • uġigħ fir-riġel(riġlejn) (uġigħ fl-estremitajiet)
English: This medicine contains potassium, less than 1 mmol (39 mg) per administration at 27 injection sites to 60 injection sites, i.e. essentially ‘potassium-free'.
Maltese: Din il-mediċina fiha potassium, inqas minn 1 mmol (39 mg) f'kull għotja f'27 sit tal-injezzjoni sa 60
English: Clinical trial CT-AMT-11-05
Maltese: Prova klinika CT-AMT-11-05
English: Glybera has minor influence on the ability to drive and use machines¸ dizziness was commonly observed after Glybera administration (see section 4.8).
Maltese: Sturdament kien osservat b'mod komuni wara l-għoti ta' Glybera (ara sezzjoni 4.8).
English: • Advice on the need and duration of barrier contraception
Maltese: • Parir dwar il-ħtieġa u t-tul ta' kontraċezzjoni barriera
English: Posology The maximum total dose of Glybera for administration is 1 x 1012 gc/kg body weight.
Maltese: Pożoloġija Id-doża massima totali ta' Glybera għall-għoti hija ta' 1 x 1012 gc/kg tal-piż tal-ġisem.
English: After treatment with Glybera do not donate blood, organs, tissues and cells for transplantation to avoid spreading cells that contain your medicine.
Maltese: Wara lkura bi Glybera, tagħtix demm, organi, tessut u ċelluli għal trapjant sabiex jiġi evitat it-tixrid ta' ċelluli li fihom il-mediċina tiegħek.
English: Hypertension
Maltese: Ipertermja
English: With the exception of a case of fever (39.9 °C) in study CT-AMT-011-01 which reversed within a day, no Glybera or immunosuppression related serious adverse events occurred.
Maltese: Bl-eċċezzjoni ta' każ ta' deni (39.9 °C) fl-istudju CT-AMT-011-01 li għadda fi żmien ġurnata, ma seħħew l-ebda avvenimenti avversi serji relatati ma' Glybera jew mal-immunosoppressjoni.
English: Muscle biopsies obtained up to 52 weeks after administration of Glybera show an infiltrate of lymphocytes and macrophages.
Maltese: Bijopsiji tal-muskoli miksuba sa 52 ġimgħa wara l-għoti ta' Glybera juru infiltrazzjoni ta' limfoċiti u makrofaġi.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS TRANSPARENT SEALED PLASTIC CASING LABEL (3 vial pack)
Maltese: TIKKETTA FUQ IL-KAXXA TRASPARENTI SSIĠILLATA TAL-PLASTIK (pakkett ta' 3 kunjetti)
English: Standard genetic analysis (sequencing) was used in the clinical studies of Glybera.
Maltese: Fil-proviFl-istudji kliniċi ta' Glybera intużat analiżi ġenetika standard (sekwenzar).
English: Clinical trial CT-AMT-11-03
Maltese: Prova klinika CT-AMT-11-03
English: Pharmacotherapeutic group: Lipid modifying agents, other lipid modifying agents, ATC code: C10AX10.
Maltese: Sustanzi li jimmodifikaw il-lipidi, sustanzi oħra li jimmodifikaw il lipidi, Kodiċi ATC:
English: The patients enrolled in clinical studies (CT-AMT-010-01, CT-AMT 01101, CT-AMT 011-02) should be followed up in the LPLD registry.
Maltese: fl-istudji kliniċi (CT-AMT-010-01, CT-AMT 011-01, CT-AMT 011-02)
English: Information on the front:
Maltese: Informazzjoni fuq wara:
English: Package leaflet: Information for the user Glybera 3 x 1012 genome copies /ml solution for injection
Maltese: Informazzjoni għall utent Glybera 3 x 1012 kopji tal-genoma /ml soluzzjoni għal injezzjoni
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS TRANSPARENT SEALED PLASTIC CASING LABEL (2 vial pack)
Maltese: TIKKETTA FUQ IL-KAXXA TRASPARENTI SSIĠILLATA TAL-PLASTIK (pakkett ta' 2 kunjetti)
English: Furthermore, Glybera allows expression of the LPL protein in injected muscle which is reflected by the improvement of postprandial chylomicron (CM) metabolism observed in a small subset of patients.
Maltese: Barra minn hekk, Glybera jippermetti l-espressjoni tal-proteina LPL filmuskolu injettat li jiġi rifless fit-titjib tal-metaboliżmu ta' chylomicron wara l-ikel (CM - postprandial chylomicron) osservat f'subsett żgħir ta' pazjenti.
English: Marketing Authorisation Holder uniQure biopharma B.V., Meibergdreef 61, 1105 BA Amsterdam, The Netherlands.
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq uniQure biopharma B.V., Meibergdreef 61, 1105 BA Amsterdam, L-Olanda.
English: Glybera should not be administered to women who are breast-feeding as long as breastfeeding is ongoing.
Maltese: Glybera huwa awtorizzat għal kura ta' darba biss.
English: 2) Educational material for physicians and other healthcare professionals involved in the treatment of patients with Glybera including the following key safety elements:
Maltese: 2) Materjal edukattiv għat-tobba u għall-professjonisti oħra tal-kura tas-saħħa involuti fil-kura ta' pazjenti bi Glybera inkluż l-elementi ewlenin li ġejjin dwar is-sigurtà:
English: Alipogene tiparvovec contains the human lipoprotein lipase (LPL) gene variant LPLS447X in a vector.
Maltese: Alipogene tiparvovec fih il-varjant LPLS447X tal-ġene tal-lipoproteina lipase tal-bniedem (LPL
English: Chiesi Pharma AB Tlf: +46 8 753 35 20
Maltese: Tlf: + 46 8 753 35 20
English: Clinical trial CT-AMT-011-02
Maltese: Prova klinika CT-AMT-011-02
English: In addition to being given Glybera, you will be given other medicines called immunosuppressants (see section 3 ‘How Glybera is used').
Maltese: Minbarra li tingħata Glybera, se tingħata mediċini oħrajn imsejħa immunosoppressanti (ara sezzjoni 3
English: NAME OF THE MARKETING AUTHORISATION HOLDER uniQure biopharma B.V.
Maltese: uniQure biopharma B.V.
English: Subjects also received a daily oral dose of 3 mg/kg/day cyclosporine and 2 g/day of mycophenolate mofetil starting three days before administration of alipogene tiparvovec through week 12.
Maltese: Is-suġġetti rċevew ukoll doża orali ta' kuljum ta' 3 mg/kg/kuljum ta' cyclosporine u 2 g/kuljum ta' mycophenolate mofetil li bdiet tlett ijiem qabel l-għoti ta' alipogene tiparvovec sa ġimgħa 12.
English: Each preformed transparent sealed plastic casing contains either 2 or 3 individual vials with a liquid absorbing sheet.
Maltese: Kull kaxxa tal-plastik preformata trasparenti u ssiġillata fiha jew 2 jew 3 kunjetti individwali b'folja li tassorbi l- likwdu.
English: Pharmacokinetics in special populations e.g. elderly/renal impairment etc. Glybera is injected directly into the target organ, skeletal muscle.
Maltese: Glybera jiġi direttament injettat fl-organu fil-mira, fil-muskoli skeletali.
English: In a follow-up period of up to 3 years after treatment, there was a decreasing trend in the incidence and severity of pancreatitis in the 12 patients who had multiple attacks during their life time.
Maltese: Fil-perjodu ta' segwitu sa 3 snin wara l-kura, kien hemm tendenza ta' tnaqqis fl-inċidenza u s-severità ta' pankreatite fit-12-il pazjent li kellhom attakki multipli matul ħajjithom.
English: In clinical trials with Glybera, antibodies against the adeno-associated virus (AAV) protein shell were present prior to treatment, in 18 out of 27 subjects; anti-AAV antibodies appeared or increased after Glybera administration, in all of the subjects.
Maltese: adeno-associated virus) kienu preżenti qabel il-kura, fi 18 minn 27 individwu; antikorpi kontra AAV dehru jew żdiedu wara l-għoti ta' Glybera, fis-suġġetti kollha.
English: • injection site discomfort, swelling, rash and pain
Maltese: • skonfort fis-sit tal-injezzjoni, nefħa, raxx u uġigħ.
English: Clinical trial CT-AMT-011-01
Maltese: Prova klinika CT-AMT-011-01
English: The MAH shall set up a long term surveillance programme/ disease registry to collect information on the epidemiology of the disease and the demographics, safety, and the effectiveness outcomes of patients treated with Glybera.
Maltese: L-MAH għandu jistabbilixxi programm ta' sorveljanza fit-tul/reġistru talmarda biex jiġbor informazzjoni dwar l-epidemjoloġija tal-marda u d demografija, is-sigurtà, u r-riżultati dwar l-effikaċja tal-pazjenti kkurati bi Glybera.
English: Glybera should under no circumstances be administered intravascularly.
Maltese: Glybera mhuwiex normalment irrakkomandat għall-użu waqt it-tqala.
English: Upon intramuscular injection, the patient will receive multiple injections of 0.5 ml (one injection per syringe), distributed over the muscles of both upper and lower legs, under aseptic conditions such as iodine.
Maltese: Wara l-injezzjoni ġol-muskolu, il-pazjent se jirċievi injezzjonijiet multipli ta' 0.5 ml (injezzjoni waħda kull siringa), imqassma fuq il-muskoli kemm fil-parti ta' fuq kif ukoll ta' isfel tar-riglejn, taħt kondizzjonijiet asettiċi bħal jodju.
English: Contusion
Maltese: Nazzjonali
English: No drug-related serious adverse events occurred and no dose-limiting toxicity was observed.
Maltese: Ma seħħew l-ebda avvenimenti avversi serji relatati mal-mediċina u ma kienet osservata l-ebda tossiċità li tillimita d-doża.
English: Clinical pharmacokinetics and shedding
Maltese: IL-PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN
English: The European Medicines Agency has waived the obligation to submit the results of studies with Glybera in all subsets of the paediatric population in the treatment of lipoprotein lipase deficiency (see section 4.2 for information on paediatric use).
Maltese: Glybera f'kull sett tal-popolazzjoni pedjatrika fil-kura ta' defiċjenza ta' lipoproteina lipase (ara sezzjoni 4.2 għal informazzjoni dwar l-użu pedjatriku).
English: Sucrose
Maltese: Anzjani
English: Chiesi Pharma AB. Sími: +46 8 753 35 20
Maltese: Sími: + 46 8 753 35 20
English: Store and transport vial frozen -25oC to -15oC.
Maltese: Kunjetti għandhom jinħażu u jiġu ttrasportat iffriżati f'temperatura ta' -25ºC sa -15ºC.
English: Meibergdreef 61, 1105 BA Amsterdam, The Netherlands.
Maltese: uniQure biopharma B.V. Meibergdreef 61, 1105 BA Amsterdam, L-Olanda.
English: Disodium phosphate
Maltese: • spażmi fil-muskoli
English: As expected, all animals developed antibodies to the AAV protein shell.
Maltese: Kif kien mistenni, l-annimali kollha żviluppaw antikorpi għall-qoxra tal-proteina tal-AAV.
English: • It is important that you tell your doctor if you have an active infection of any sort before you take the medicines you will be given to reduce your body's defences (immunosuppressants) and before you receive Glybera.
Maltese: • Huwa importanti li tgħid lit-tabib tiegħek jekk għandek infezzjoni attiva ta' kwalunkwe tip qabel ma tieħu l-mediċini li ser tingħata biex tnaqqas id-difiżi tal-ġisem tiegħek (mediċini immunosoppressanti) u qabel ma tirċievi Glybera.
English: In lipoprotein lipase deficiency, this enzyme is missing due to a genetic defect.
Maltese: Fid-defiċjenza tal-lipoproteina lipażi, din l-enzima hija nieqsa minħabba difett ġenetiku.
English: Potassium chloride
Maltese: GĦAMLA KWALITATTIVA
English: What you need to know before you are given Glybera Do not receive Glybera
Maltese: Id-detentur ta' din il-kartuna irċieva Glybera,
English: Each vial of alipogene tiparvovec contains 1 ml of solution, containing 3 x 1012 genome copies (gc).
Maltese: Kull kunjett ta' alipogene tiparvovec fih 1 ml ta' soluzzjoni li, li fiha 3 x 1012 kopji tal-genoma (gcgenome copies).
English: No clinical data on the effect of Glybera on fertility are available.
Maltese: Fertilità Ma hemm l-ebda dejta klinika disponibbli fuq l-effett ta' Glybera fuq il-fertilità.
English: You need to take this into consideration if you are on a controlled sodium diet.
Maltese: Għandek tieħu dan f'konsiderazzjoni jekk tkun fuq dieta ta' sodium ikkontrollat.
English: • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being
Maltese: • Fi żmien 60 jum minn meta jintlaħaq għan importanti (farmakoviġilanza jew minimizzazzjoni tar-riskju);
English: Patient Code number:
Maltese: Kategorija farmakoterapewtika:
English: Glybera should under no circumstances be administered intravascularly (see section 4.4).
Maltese: methylprednisolone ġol-vina (ara sezzjoni 4.4).
English: Glybera is used to treat a specific inherited condition known as “lipoprotein lipase deficiency (LPLD)”.
Maltese: Glybera jintuża fil-kura ta' pazjenti adulti dijanjostikati bid-defiċjenza tal-lipoproteina lipase (LPLD)
English: In clinical studies a transient reduction in triglycerides for up to 12 weeks in individual patients could be observed.
Maltese: Fi studji kliniċi seta jiġi osservat tnaqqis temporanju fit-triġliċeridi sa 12-il ġimgħa f'pazjenti individwali.
English: After the amount of Glybera to be administered has been calculated (see section 4.2) remove the correct number of single use vials from the freezer to thaw at room temperature (15oC to 25oC), approximately 30-45 minutes in advance of syringe filling.
Maltese: 6.4 Prekawzjonijiet speċjali għall-ħażna Aħżen u ġorr il-kunjett iffriżat f'temperatura ta' -25°C sa -15°C.
English: The other ingredients are, disodium phosphate, potassium chloride, potassium dihydrogen phosphate, sodium chloride, sucrose, and water for injections.
Maltese: Is-sustanzi l-oħra huma disodium phosphate, potassium chloride, potassium dihydrogen phosphate,
English: Intramuscular use.
Maltese: ultrasound tal-injezzjonijiet.
English: Fatigue, Hyperthermia
Maltese: Uġigħ fl estremitajiet
English: Each vial contains 1 extractable ml of solution containing 3 × 1012 genome copies (gc) of alipogene tiparvovec.
Maltese: Kull kunjett ta' alipogene tiparvovec fih 1 ml ta' soluzzjoni li tista' tiġi estratta, li fiha 3 x 1012 kopji tal-genoma (gc - genome copies).
English: See package leaflet for further information.
Maltese: Lista tabulata ta' reazzjonijiet avversi
English: Follow applicable local or international guidelines for prophylaxis (See also section 4.5).
Maltese: Segwi l-linji gwida lokali jew internazzjonali applikabbli għal profilassi (Ara wkoll sezzjoni 4.5).
English: The safety and efficacy of Glybera in children and adolescents below 18 years has not been established.
Maltese: Is-sigurtà u l-effikaċja ta' Glybera fit-tfal u fl-adolexxenti taħt it-18-il sena ma ġewx determinati s'issa.
English: • You should continue to follow a fat-restricted, alcohol-free diet. People diagnosed with lipoprotein lipase deficiency are advised to be careful with their diet, both before and after Glybera therapy; they should restrict their intake of ‘normal diet fats' and should not drink
Maltese: Persuni dijanjostikati bid- defiċjenza ta' lipoproteina lipase huma avżati biex joqogħdu attenti bid dieta tagħhom, kemm qabel kif ukoll wara t-terapija bi Glybera; għandhom jirrestrinġu lkonsum ta' ‘xaħmijiet normali fid-dieta' u m'għandhomx jixorbu alkoħol.
English: Liver and kidney function, cytochrome P450 polymorphisms and ageing are not expected to influence the clinical efficacy or safety of Glybera.
Maltese: Il-funzjoni tal-fwied u tal kliewi, polimorfiżmi taċ-ċitokromju P450 u x-xjuħija mhumiex mistennija li jinfluwenzaw l-effikaċja klinika jew is- sigurtà ta' Glybera
English: The aim of this open label, dose escalating study was to assess the safety profile and reduction of fasting plasma triglyceride (TG) levels after 12 weeks post Glybera administration in 14 LPLD patients.
Maltese: Id-detentur m'għandux jagħti demm, organi jew tessut u għandu juża kontraċezzjoni barriera tal-inqas 12-il xahar wara l-kura bi Glybera.
English: There is the theoretical risk that the co-administration of the immunosuppressant regime leads to longer persistence of virus DNA in serum and as well to longer shedding in saliva, urine and semen.
Maltese: Hemm ir-riskju teoretiku li l-għoti flimkien tal-kors ta' immunosoppressanti jwassal għal persistenza itwal tad-DNA tal-virus fis-serum kif ukoll għal eliminazzjoni itwal fil-bżieq, fl-awrina u fis-semen.
English: No dose adjustment of Glybera is required.
Maltese: It-treddigħ mhuwiex rakkomandat waqt kura bi Glybera.
English: Chiesi Farmaceutici S.p.A. Tηλ: + 39 0521 2791
Maltese: Tηλ: + 39 0521 2791
English: 1) on efficacy data such as biochemical markers as part of normal practice and frequency and severity of pancreatitis and 2) on safety including immunogenicity against Glybera and LPL.
Maltese: 2) dwar is-sigurtà inkluż l-immunoġeniċità kontra Glybera u LPL.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: Artikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikat fuq ilportal elettroniku Ewropew tal-mediċini.
English: • Increased blood level of the muscle enzyme creatine kinase
Maltese: • Żieda tal-livell fid-demm tal-enzima tal-muskoli creatine kinase.
English: There is limited experience in the use of Glybera in patients with renal or hepatic impairment.
Maltese: Hemm esperjenza limitata dwar l-użu ta' Glybera f'pazjenti b'indeboliment renali jew epatiku.
English: Renal impairment or hepatic impairment
Maltese: Indeboliment renali jew epatiku
English: The MAH shall perform the pharmacovigilance activities detailed in the Pharmacovigilance Plan and the Efficacy Follow-up Plan as agreed in the Risk Management Plan presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the Committee for Medicinal Products for Human Use (CHMP).
Maltese: L-MAH għandu jwettaq l-attivitajiet ta' farmakoviġilanza dettaljati fil-Pjan ta' Farmakoviġilanza u lPjan ta' Tkomplija dwar l-Effikaċja kif inhu maqbul fil-Pjan tal-Ġestjoni tar-Riskju ippreżentat filModulu 1.8.2 tal-Applikazzjoni għall-Awtorizzazzjoni għat-Tqegħid fis-Suq u kwalunkwe aġġornament sussegwenti tal-RMP kif maqbul mill-Kumitat għall-Prodotti Mediċinali għall-Użu mill
English: Glybera Patient Alert Card
Maltese: Glybera Skeda Kartuna ta' Twissija għall-Pazjent
English: Glybera shall only be supplied if the healthcare professionals involved in the treatment of a patient have received the educational pack and if the prescriber confirms that the patient agrees to participate in the registry.
Maltese: Glybera għandu jingħata biss jekk il-professjonisti tal-kura tas-saħħa involuti fil-kura ta' pazjent jkunu rċevew il-pakkett edukattiv u jekk min jippreskrivi jikkonferma li l-pazjent jaqbel li jipparteċipa fir-reġistru.
English: LPL protein mass should be measured in a blood sample from the patient against a control sample from healthy volunteers.
Maltese: Il-massa tal-proteina LPL għandha titkejjel f'kampjun tad-demm mill-pazjent kontra kampjun ta' kontroll minn voluntiera f saħħithom.
English: Present this card to health care professionals (doctor, nurse) upon consultation or hospitalization!
Maltese: Ippreżenta din il-kartuna lillprofessjonisti tal-kura tas-saħħa (tabib, infermier) waqt konsultazzjoni jew kura fl-isptar!
English: Elderly There is limited experience in the use of Glybera in elderly subjects.
Maltese: Hemm esperjenza limitata fl-użu ta' Glybera f'individwi anzjani.
English: Glybera therapy must be prescribed by and administered under the supervision of a physician with expertise in treating LPLD patients and in gene therapy administration, in full consultation with the patient.
Maltese: Terapija bi Glybera għandha tiġi preskritta u tingħata taħt is-superviżjoni ta' tabib b'kompetenza filkura ta' pazjenti b'LPLD u fl-għoti ta' terapija tal-ġeni, f'konsultazzjoni sħiħa mal-pazjent.
English: Carcinogenicity studies have not been conducted.
Maltese: Ma sarux studji ta' karċinoġeniċità.
English: Abdominal pain.Nausea, Constipation
Maltese: Uġigħ addominali, Dardir, Stitikezza
English: Chiesi Pharma AB Tel: +46 8 753 35 20
Maltese: Tel: + 46 8 753 35 20
English: Individual lot number: Date of treatment:
Maltese: Numru tal-lott individwali:
English: Glybera contains alipogene tiparvovec, a gene therapy product that works by delivering a gene into the body to correct a genetic deficiency.
Maltese: Glybera fih alipogene tiparvovec, prodott ta' terapija tal-ġeni li jaħdem billi jwassal ġene fil-ġisem biex jikkoreġi defiċjenza ġenetika.
English: Preparation of Glybera for administration
Maltese: Preparazzjoni ta' Glybera għall-għoti
English: Diabetic patients
Maltese: Pazjenti dijabetiċi
English: The elements of the vector were chosen such that expression of the LPL S447X gene is promoted, by co-opting the expression machinery of the cell and the myocytes produce the protein product of the transgene LPL S447X without the vector being able to reproduce itself.
Maltese: Irreferi għal-linji gwida lokali dwar il-bijosigurtà applikabbli għall-immaniġġar u r-rimi ta' prodotti mediċinali li fihom organiżmi ġenetikament modifikati.
English: Glybera is a clear to slightly opalescent, colourless solution for injection, supplied in a clear glass vial with a siliconised injection stopper and flip-off seal.
Maltese: Glybera huwa soluzzjoni għal injezzjoni ċara għal ftit opalexxenti, mingħajr kulur, li tiġi f'kunjett trasparenti talħġieġ b'tapp tal-injezzjoni silikonizzat u sigil tat-tip flip-off.
English: • tiredness (fatigue)
Maltese: TWISSIJA(IET) SPEĊJALI