FrancophonIA/ELRC3.0 huggingface dataset:
English: Prednisolone is an intermediate acting corticosteroid having about 4 times the anti-inflammatory activity and about 0.8 times the sodium-retaining effect of cortisol.
Maltese: Prednisolone huwa kortikosterojdi li jaġixxi b'mod intermedju b'madwar 4 darbiet l-attività antiinfjammatorja u madwar 0.8 darbiet l-effett taż-żamma tas-sodju ta' kortisol.
English: 3421 TV Oudewater The Netherlands
Maltese: 3421 TV Oudewater Il-Pajjiżi l-Baxxi
English: The excipients listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required, or considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Maltese: L-eċċipjenti elenkati f'sezzjoni 6.1 tas-sommarju tal-karatteristiċi tal-prodott (SPC) huma jew sustanzi ammissibbli li għalihom m'hemmx bżonn ta' limiti massimi ta' residwi (MRLs) kif indikat fit-tabella numru 1 tal-anness għar-Regolament tal-Kummissjoni (UE) Nru 37/2010, jew huma kkunsidrati li ma jaqgħux fi ħdan l-iskop tar-Regolament (KE) Nru 470/2009 meta użati bħal f'dan il-prodott mediċinali veterinarju.
English: Cardboard box containing one HDPE (white) jar with LDPE tear band lid containing 180 gram or 504 gram of oral powder and one polystyrene (colourless) measuring spoon (measuring 4.6 grams of oral powder).
Maltese: Kaxxa tal-kartun li fiha vażett wieħed (abjad) tal-HDPE b'għatu tal-LDPE b'faxxa li tinqala (tear band) li fih 180 grammi jew 504 grammi ta' trab orali u mgħarfa waħda tal-kejl tal-polisterin (mingħajr kulur) (li tkejjel 4.6 grammi ta' trab orali).
English: Jar with measuring spoon (1 spoon = 4.6 g powder) Number of spoons
Maltese: Vażett b'kuċċarina tal-kejl (Mgħarfa 1 = 4.6 g ta' trab) Għadd ta' kuċċarini
English: Do not use in viral infections in which the virus particles circulate in the bloodstream or in cases of systemic fungal infections.
Maltese: Tużax f'infezzjonijiet virali li fihom il-partiċelli tal-virus jiċċirkolaw fil-fluss tad-demm jew f'każijiet ta' infezzjonijiet fungali sistemiċi.
English: Withdrawal period: Meat and offal: 10 days.
Maltese: Laħam u ġewwieni tal-annimali:10 ijiem.
English: BATCH NUMBER
Maltese: Numru ta' qratas
English: Treatment with prednisolone should only be initiated when satisfactory alleviation of clinical symptoms have not been obtained or are unlikely to be obtained by environmental control alone.
Maltese: Il-kura bi prednisolone għandha tinbeda biss meta taffija sodisfaċenti tas-sintomi kliniċi ma tkunx inkisbet jew ma tkunx probabbli li tinkiseb permezz ta' kontroll ambjentali waħdu.
English: Corticoids/ Glucocorticoids
Maltese: Kortikojdi Glukokortikojdi
English: Do not use in animals suffering from diabetes mellitus, renal insufficiency, cardiac insufficiency, hyperadrenocorticism, or osteoporosis.
Maltese: Tużax f'annimali li jbatu minn dijabete mellitus, insuffiċjenza renali, insuffiċjenza kardijaka, iperadrenokortiċiżmu, jew osteoporożi.
English: Overdose (symptoms, emergency procedures, antidotes) Short-term administration of even large doses is unlikely to cause serious harmful systemic effects.
Maltese: Doża eċċessiva (sintomi, proċeduri ta' emerġenza, antidoti) Amministrazzjoni għal perjodu ta' żmien qasir anki ta' dożi kbar mhijiex probabbli li tikkawża effetti sistemiċi ta' ħsara.
English: Animal species
Maltese: KG Animal Health
English: Horses
Maltese: Vażett
English: Jar with 180 g or 504 g oral powder.
Maltese: U KWANTITATTIVA Vażett bi trab orali ta' 180 g jew ta' 504 g.
English: Active substance: prednisolone
Maltese: Sustanza attiva: prednisolone 33.3 mg
English: T½ is 3.1 ±2.3 hours but is not meaningful from a therapy standpoint when evaluating systemic corticosteroids.
Maltese: It-T½ huwa ta' 3.1 ±2.3 sigħat iżda millperspettiva ta' terapija mhuwiex sinifikanti meta l-kortikosterojdi sistemiċi jkunu qegħdin jiġu vvalutati.
English: Following cessation of treatment, signs of adrenal insufficiency extending to adrenocortical atrophy can arise and this may render the animal unable to deal adequately with stressful situations.
Maltese: Wara li l-kura titwaqqaf, jista' jkun hemm sinjali ta' insuffiċjenza adrenali li testendi għal atrofija adrenokortikali u dan jista' jagħmel lill-annimal inkapaċi li jiffaċċja b'mod adegwat sitwazzjonijiet stressanti.
English: 300 mg prednisolone per 9 g sachet 600 mg prednisolone per 18 g sachet
Maltese: 100 mg prednisolone għal kull qartas ta' 3 g 300 mg prednisolone għal kull qartas ta' 9 g 600 mg prednisolone għal kull qartas ta' 18 g
English: 4.1 Target species
Maltese: 4.1 Speċi fil-mira
English: In order to prevent dust formation, do not shake the veterinary medicinal product.
Maltese: Sabiex jiġi evitat li jifforma t-trab, tħawwadx il-prodott mediċinali veterinarju.
English: The concomitant use of this veterinary medicinal product with non-steroidal anti-inflammatory drugs may exacerbate gastrointestinal tract ulceration.
Maltese: L-użu konkomitanti ta' dan il-prodott mediċinali veterinarju ma' mediċini antiinfjammatorji mhux sterojdi jista' jaggrava ulċerazzjoni tal-passaġġ gastro-intestinali.
English: Number of spoons
Maltese: NUMRU TAL-LOTT
English: Deutschland Boehringer Ingelheim Vetmedica GmbH Binger Str. 173
Maltese: Boehringer Ingelheim GmbHAnimal Health UK Ltd
English: Liver Kidney
Maltese: TAGĦRIF
English: Република България Boehringer Ingelheim RCV GmbH & Co KG Animal Health Dr. Boehringer-Gasse 5-11 1121 Виена
Maltese: Република България Boehringer Ingelheim RCV GmbH & Co
English: Jar
Maltese: UŻU
English: Horses.
Maltese: Żwiemel.
English: Administration in late pregnancy is likely to cause abortion or early parturition in ruminants and may have a similar effect in other species.
Maltese: Lgħoti tard fit-tqala x'aktarx li jikkawżaw abort jew ħlas kmieni f'annimali li jixtarru u jista' jkollu effett simili fi speċi oħra.
English: Affected horses are susceptible to inhaled antigens and other pro-inflammatory agents, including fungal spores and dust-derived endotoxin.
Maltese: Iż-żwiemel affettwati huma suxxettibbli għal antiġeni inalati u aġenti proinfjammatorji oħra, inklużi spori fungali u endotossini li ġejjin mit-trab.
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports)
Maltese: Il-frekwenza ta' effetti mhux mixtieqa hija definita skont il-konvenzjoni li ġejja: - komuni ħafna (aktar minn wieħed f'10 annimali ttrattati li juru effetti mhux mixtieqa matul ilperjodu ta' kura waħda) - komuni (aktar minn wieħed iżda inqas minn 10 annimali f'100 annimal ittrattati) - mhux komuni (aktar minn wieħed iżda inqas minn 10 annimali f'1,000 annimal ittrattati ) - rari (aktar minn wieħed iżda inqas minn 10 annimali f'10,000 annimal ittrattati ) - rari ħafna (inqas minn annimal wieħed f'10,000 annimal ittrattati, inklużi rapporti iżolati)
English: The treatment should be combined with environmental control.
Maltese: Il-kura għandha tkun ikkombinata ma' kontroll ambjentali.
English: One gram contains:
Maltese: Perjodu ta' tiżmim:
English: Administration in early pregnancy is known to have caused foetal abnormalities in laboratory animals.
Maltese: L-għoti fil-bidu tat-tqala huwa magħruf li kkawża anormalitajiet fil-fetu f'annimali fil-laboratorju.
English: Equisolon 33 mg/g oral powder for horses
Maltese: Equisolon 33 mg/g trab orali għaż-żwiemel
English: Bodyweight (kg) of horse
Maltese: Piż tal-ġisem (kg) taż-żiemel
English: A single dose of 1 mg prednisolone/kg body weight per day corresponds to 100 mg prednisolone in a 3 g sachet per 100 kg body weight (see dosing table below).
Maltese: Doża unika ta' 1 mg ta' prednisolone/kg tal-piż tal-ġisem kuljum li tikkorrispondi għal 100 mg prednisolone f'qartas ta' 3 g għal kull 100 kg tal-piż tal-ġisem (ara t-tabella ta' dożaġġ hawn taħt).
English: Withdrawal period:
Maltese: Data tal-aħħar tiġdid:
English: Very rarely, neurological signs such as ataxia, recumbency, head tilting, restlessness or incoordination have been observed after use of the product.
Maltese: B'mod rari ħafna, wara l-użu tal-prodott ġew osservati sinjali newroloġiċi bħal atassja, rikumbenza, liwi tar-ras, irrikwetezza jew nuqqas ta' koordinazzjoni.
English: The significant dose related cortisol suppression very commonly noticed during therapy is a result of effective doses suppressing the hypothalamo-pituitreal adrenal axis.
Maltese: It-trażżin sinifikanti ta' kortisol relatat mad-doża innotat b'mod komuni ħafna matul it-terapija huwa riżultat ta' dożi effettivi li jrażżnu l-assi adrenali ipotalamika-pitwitarja.
English: PACKAGE LEAFLET Equisolon 33 mg/g oral powder for horses
Maltese: VETERINARJU Equisolon 33 mg/g trab orali għaż-żwiemel
English: 31 December 2022
Maltese: 31 Diċembru 2022
English: Diet
Maltese: Dieta
English: The active substance is alipogene tiparvovec.
Maltese: Is-sustanza attiva hi alipogene tiparvovec.
English: 1105 BA Amsterdam The Netherlands
Maltese: 1105 BA Amsterdam L-Olanda
English: LPLD involves a state of hyperviscosity/hypercoagulability.
Maltese: LPLD tinvolvi stat ta' iperviskożità/hypercoagulability.
English: Glybera contains sodium and potassium.
Maltese: Glybera fih sodium u potassium.
English: • Oral contraceptive use (see section 4.6).
Maltese: • L-użu ta' kontraċettivi orali (ara sezzjoni 4.6).
English: The vector comprises a protein shell derived from adeno-associated virus serotype 1 (AAV1), the Cytomegalovirus (CMV) promoter, a woodchuck hepatitis virus posttranscriptional regulatory element and AAV2 derived inverted terminal repeats.
Maltese: Il-vettur fih qoxra magħmula minn proteina li ġejja minn virus adeno assoċjat ta' serotip 1 (AAV1 - adeno-associated virus serotype 1), il-promutur ta' Cytomegalovirus (CMV), element post traskrizzjonali regolatorju tal-virus woodchuck tal-epatite u inverted terminal repeats ġejjin minn AAV2.
English: • Information on the need to avoid pregnancy
Maltese: • Informazzjoni dwar il-ħtieġa li tiġi evitata t-tqala
English: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to
Maltese: Komuni ħafna (≥1/10); komuni (≥1/100 sa <1/10); mhux komuni (≥1/1,000 sa <1/100); rari (≥1/10,000 sa <1/1,000); rari ħafna(<1/10,000), mhux magħruf (ma jistax jiġi stmat mid-dejta disponibbli).
English: Hair growth abnormal, Palmar-plantar erythrodysaesthesia syndrome, Rash
Maltese: Tkabbir anormali tax-xagħar, Sindrome ta' eritrodisasteżija Palmari-plantari, Raxx
English: Blue Box
Maltese: Kaxxa Blu
English: Date of first authorisation: 25 October 2012
Maltese: Data tal-ewwel awtorizzazzjoni: 25 ta' Ottubru 2012
English: Examples of these immunosuppressants are ciclosporin, mycophenolate mofetil.
Maltese: Eżempji ta' dawn l-immunosoppressanti huma ciclosporin, mycophenolate mofetil.
English: Serum creatine kinase
Maltese: creatine kinase fis-serum.
English: Store frozen at -25°C to -15°C.
Maltese: Aħżen fil-friża f'temperatura ta' -25°C sa -15°C.
English: Study CT-AMT-011-03 was a combined retrospective and prospective study of subjects who had taken part in studies CT-AMT-10-01, CT-AMT-11-01, CT-AMT-11-02.
Maltese: Studju CT-AMT-011-03 kien studju retrospettiv u prospettiv kombinat ta' individwi li kienu ħadu sehem fl-istudji CT-AMT-10-01, CT-AMT-11-01, CT-AMT-11-02.
English: A single intravenous bolus of methylprednisolone (1 mg/kg bodyweight) was given 30 minutes prior to alipogene tiparvovec administration.
Maltese: Bolus wieħed ta' methylprednisolone (1 mg/kg tal-piż tal-ġisem) ingħata ġol-vina 30 minuta qabel l-għoti ta' alipogene tiparvovec.
English: Glybera with alcohol
Maltese: Glybera ma' alkoħol
English: Glybera should only be administered to patients with an LPL protein mass of at least 5% of normal.
Maltese: Glybera għandu jingħata biss lil pazjenti b'massa tal-proteina LPL ta' mill-inqas 5% tan-normal.
English: • Oral contraceptives (see section 2 ‘Do not receive Glybera')
Maltese: • Kontraċettivi orali (ara sezzjoni 2 ‘Tiħux Glybera') Glybera ma' alkoħol
English: • raised body temperature
Maltese: • żieda fit-temperatura tal-ġisem
English: Pain in extremity Arthritis, Limb discomfort, Muscle spasms, Muscle strain, Musculoskeletal stiffness, Myalgia, Muscle pain, Neck pain, Sensation of heaviness, Acute myositis and chronic myositis
Maltese: Artrite, Skumdità fir-riġlejn jew fid-dirgħajn, Spażmi fil-muskoli, Tensjoni fil-muskoli, Ebusija muskolu-skeletrali, Majalġja, Uġigħ fil-muskoli,
English: • Glybera is a gene therapy product.
Maltese: • Glybera huwa prodott ta' terapija tal-ġeni.
English: Other medicines and Glybera
Maltese: Mediċini oħra u Glybera
English: Alipogene tiparvovec is produced using insect cells and recombinant baculovirus technology.
Maltese: Alipogene tiparvovec jiġi prodott permezz ta' ċelluli tal-insetti u teknoloġija rikombinanti tal-baculovirus.
English: See also section 3, ‘How Glybera is used'.
Maltese: Ara wkoll sezzjoni 3, "Kif għandu jingħatalek Glybera".
English: AAV1-LPLS447X was administered to 8 LPLD patients in a 12-week, open label dose escalating study (1 x 1011 gc to 3 x 1011 gc per kg body weight i.m.).
Maltese: AAV1-LPLS447X ingħata lil 8 pazjenti b'LPLD fi studju fuq 12-il ġimgħa, b'tikketta miftuħa u b'doża li teskala (1 x 1011 gc sa 3 x 1011 gc għal kull kg tal-piż tal-ġisem i.m.).
English: Alipogene tiparvovec ▼ This medicine is subject to additional monitoring.
Maltese: ▼ Dan il-prodott mediċinali huwa suġġett għal monitoraġġ addizzjonali.
English: Dyspnoea exertional, Pulmonary embolism
Maltese: Qtugħ ta' nifs mal-istrapazz, Emboliżmu pulmonari
English: Limited data are available in diabetic patients.
Maltese: Id-dejta disponibbli fuq pazjenti dijabetiċi hija limitata.
English: MedDRA System Organ Class Metabolism and nutrition disorders
Maltese: Klassi tas-Sistemi u talOrgani MedDRA
English: Strict compliance with dietary fat restriction was difficult.
Maltese: Konformità stretta ma' restrizzjoni ta' xaħam fid-dieta kienet diffiċli.
English: The dose per injection site is 1.5 x 1012 gc, or 0.5 ml of solution for injection.
Maltese: Id-doża f'kull sit talinjezzjoni hija ta' 1.5 x 1012 gc, jew ta' 0.5 ml ta' soluzzjoni għal injezzjoni.
English: • The need to provide the educational material to patients and request their informed consent to be enrolled into the registry prior to treatment o the need and duration of barrier contraception o not to donate organs nor blood nor cells o on the need to continue on a low-fat diet and avoid drinking alcohol o the necessity to carry the patient alert card, that is included in each pack, with them at o that enrolment is mandatory for patients treated with Glybera o that patients treated with Glybera in a clinical trial should be enrolled in the registry at o that, where possible, patients with familial LPLD who are not treated with Glybera o the need to obtain the patient's informed consent prior to treatment o how to enter patients in it - including those not treated with Glybera
Maltese: • Il-ħtieġa li pazjenti jingħataw parir dwar: o il-ħtieġa u t-tul ta' kontraċezzjoni barriera o biex ma jagħtux organi u lanqas demm u lanqas ċelluli o dwar il-ħtieġa li jkomplu fuq dieta b'livell baxx ta' xaħam u jevitaw ix-xorb tal alkoħol o il-ħtieġa li jġorru-kartuna l-iskeda ta' twissija għall-pazjent, li hija nkluża f'kull pakkett, magħhom f'kull ħin o l-użu ta' djarju ta' avvenimenti
English: Pack size 2 vials
Maltese: Daqs tal-pakkett 2 kunjetti
English: Work surfaces and material which have potentially been in contact with Glybera must be decontaminated with appropriate virucidal disinfectants with activity for non-enveloped viruses (such as hypochlorite and chlorine releasers) for at least 10 minutes.
Maltese: L-uċuh tal-xogħol u materjali li potenzjalment setgħu ġew f'kuntatt ma' Glybera għandhom jiġu dekontaminati b'disinfettanti xierqa kontra l-virusis b'attività għal virusis non-enveloped (bħal hypochlorite u chlorine releasers) għal mill-inqas 10 minuti.
English: Pre-clinical studies with doses ten times the recommended dose (1 x 1013 gc/kg) did not lead to any general systemic untoward signs or symptoms.
Maltese: Studji pre-kliniċi b'dożi għaxar darbiet id-doża rakkomandata (1 x 1013 gc/kg) ma wasslu għall-ebda sinjali jew sintomi sistemiċi ġenerali mhux mixtieqa.
English: Treatment with Glybera does not eliminate attacks of acute pancreatitis.
Maltese: Trattament b'Glybera ma jeliminax attakki ta' pankreatite akuta.
English: Additional monitoring tests
Maltese: Testijiet addizzjonali ta' monitoraġġ
English: 1 ml solution in a 2 ml vial (glass) with siliconised chlorobutyl, injection stopper and flip-off seal.
Maltese: Soluzzjoni ta' 1 ml f'kunjett (ħġieġ) ta' 2 ml b'tapp tal-injezzjoni ta' chlorobutyl silikonizzat, u siġill tat- tip flip-off.
English: Number of 1 ml syringes (each filled) with 0.5 ml)
Maltese: Għadd ta' siringi ta' 1 mL (kull waħda mimlija b'0.5 ml)
English: Name and address of the manufacturer(s) of the biological active substance uniQure biopharma B.V. Meibergdreef 45 and 61 1105 BA Amsterdam The Netherlands
Maltese: Isem u indirizz tal-manifattur(i) tas-sustanza bijoloġika attiva uniQure biopharma B.V. Meibergdreef 45 and 61 1105 BA Amsterdam L-Olanda
English: How to store Glybera
Maltese: X'fih Glybera
English: The indication is restricted to patients with detectable levels of LPL protein (see section 4.4).
Maltese: L-indikazzjoni hija restritta għal pazjenti b'livelli osservabbli tal-proteina LPL (ara sezzjoni 4.4).
English: A demonstrable improvement of postprandial CM metabolism was shown in 5/5 patients up to week 14 and in 3/3 patients who were followed up to 52 weeks.
Maltese: Titjib dimostrabbli tal-metaboliżmu ta' CM wara l-ikel intwera f'5/5 tal-pazjenti sa ġimgħa 14 u fi 3/3 tal-pazjenti li kienu segwiti sa 52 ġimgħa.
English: The patients in CT-AMT-010-01 have been followed for up to 5 years (n=6) post therapy administration, those in CT-AMT-011-01 for up to 5 years (n=13), and those in CT-AMT-011-02 for up to 1 year (n=3).
Maltese: Il-pazjenti fi CT-AMT010-01 ġew segwiti sa 5 snin (n=6) wara l-għoti tat-terapija, dawk fi CT-AMT-011-01 sa 5 snin (n=13), u dawk fi CT-AMT- 011-02 sa sena (n=3).
English: Pack size 3 vials
Maltese: Daqs tal-pakkett 3 kunjetti
English: Manufacturer uniQure biopharma B.V., Meibergdreef 61, 1105 BA Amsterdam, The Netherlands.
Maltese: Manifattur uniQure biopharma B.V., Meibergdreef 61, 1105 BA Amsterdam, L-Olanda.
English: In gonads and reproductive organs, vector DNA copies were found at low levels.
Maltese: Fil-gonadi u fl-organi riproduttivi, kopji tad-DNA tal-vettur instabu f'livelli baxxi.
English: • A medicine impacting blood coagulation e.g. acetylsalicylic acid (e.g.aspirin), a substance present in many medicines used to relieve pain and lower fever, as well as medicines used to prevent blood clotting eg anticoagulants such as warfarin, heparin.
Maltese: • Mediċina li taffettwa l-koagulazzjoni tad-demm eż. acetylsalicylic acid (eż.aspirina), sustanza preżenti f'ħafna mediċini użati biex itaffu l-uġigħ u jnaqqsu d-deni, kif ukoll medicini użati biex jipprevjenu t-tagħqid tad-demm, eż. antikoagulanti bħal warfarin, heparin.
English: Lipoprotein lipase is a key ‘first step' enzyme in the metabolism of lipoproteins following fat intake with diet.
Maltese: Il-lipoproteina lipase hija enzima ewlenija tal-‘ewwel pass' fil-metaboliżmu ta' lipoproteini wara t teħid ta' xaħam mad-dieta.
English: Tabulated list of adverse reactions Adverse reactions are listed below by MedDRA body system organ class and by frequency.
Maltese: Reazzjonijiet avversi huma elenkati hawn taħt skont il-klassi tas-sistemi u tal-organi MedDRA u skont il-frekwenza.
English: From three days prior to and for 12 weeks following Glybera administration an immunosuppressive regimen should be administered: ciclosporin (3 mg/kg/day) and mycophenolate mofetil (2 x 1 g/day) is recommended.
Maltese: Minn tlett ijiem qabel u sa 12-il ġimgħa wara l-għoti ta' Glybera għandu jingħata kors immunosoppressiv: ciclosporin (3 mg/kg/kuljum) u mycophenolate mofetil (2 x 1 g/kuljum) huma rakkomandati.
English: When reporting possible adverse reactions, please include the individual lot number imprinted on the front of this card.
Maltese: Meta tirrapporta reazzjonijiet avversi possibbli, jekk jogħġbok inkludi n-numru tal-lott individwali stampat fuq quddiem ta' din il-kartuna.
English: As this medicine is given to you by a doctor, it is unlikely that you will be given too much.
Maltese: Peress li din il-mediċina tingħatalek minn tabib, huwa improbabbli li tingħata żżejjed.
English: This medicine has been authorised under "exceptional circumstances”.
Maltese: Dan il-prodott mediċinali kien awtorizzat taħt ‘ċirkustanzi eċċezzjonali'.
English: One patient was diagnosed with pulmonary embolism 7 weeks after therapy.
Maltese: Pazjent wieħed ġie dijanjostikat b'emboliżmu pulmonari 7 ġimgħat wara t-terapija.
English: Information for health care professionals: The holder of this card has received Glybera, a gene therapy medicinal product for familial lipoprotein lipase deficiency, containing genetically modified organisms.
Maltese: prodott mediċinali ta' terapija tal-ġeni għal defiċjenza familjali tal-lipoproteina lipase, li fih organiżmi ġenetikament modifikati.
English: The product contains less than 1 mmol (39 mg) potassium per administration of 27-60 injection sites ; i.e. essentially potassium-free.
Maltese: Il-prodott fih anqas minn 1 mmol (39 mg) ta' potassium f'kull għotja ta' 27-60 sit tal-injezzjoni;
English: Tel: ++386-1-43 00 901
Maltese: Chiesi Slovenija d.o.o. Tel: ++386-1-43 00 901
English: The clinical efficacy and safety of Glybera has been evaluated in three interventional clinical studies with AAV1-LPLS447X in LPLD subjects.
Maltese: L-effikaċja klinika u s-sigurta ta' Glybera ġew evalwati fi tliet studji kliniċi ta' intervent b'AAV1LPLS447X f'suġġetti b'LPLD.
English: Glybera 3 × 1012 genome copies/ml solution for injection Alipogene tiparvovec
Maltese: Glybera 3 × 1012 kopji tal-genoma/ml soluzzjoni għal injezzjoni Alipogene tiparvovec
English: This medicinal product contains 47.5 mg sodium per administration at 27 injection sites to 105.6 mg sodium per administration at 60 injection sites.
Maltese: Kontenut ta' sodium u ta' potassium sodium f'kull għotja f'27 sit tal-injezzjoni sa 105.6 mg ta' sodium f'kull għotja f'60 sit tal-injezzjoni.
English: Name and address of the manufacturer(s) responsible for batch release uniQure biopharma B.V. Meibergdreef 61
Maltese: Isem u indirizz tal-manifattur(i) responsabbli għall-ħruġ tal-lott uniQure biopharma B.V. Meibergdreef 61
English: Spinal anaesthesia and multiple intramuscular injections may further increase the risk of (thrombo) embolic events at and shortly after administration of Glybera.
Maltese: Loppju spinali u injezzjonijiet multipli ġolmuskolu jistgħu jkomplu jżidu r-riskju ta' avvenimenti (trombo) emboliċi waqt u ftit wara l-għoti ta'
English: In mice local cellular infiltrates and signs of degeneration and regeneration without necrosis, were seen at the clinical dose in the injected muscle upon histopathological examination.
Maltese: Fil-ġrieden, infiltrati ċellulari lokali u sinjali ta' deġenerazzjoni u riġenerazzjoni mingħajr nekrosi, dehru fid-doża klinika fil-muskolu injettat wara eżaminazzjoni istopatoloġika.
English: Glybera contains the human LPL gene variant LPL S447X in an adeno-associated virus serotype 1 (AAV1) vector intended to target the muscle.
Maltese: Glybera fih il-varjant LPLS447X tal-ġene uman LPL f'vettur ta' virus adeno-assoċjat ta' serotip 1
English: The educational pack for healthcare professionals must be agreed with the National Competent Authorities prior to distribution and consist of the following components:
Maltese: Il-pakkett edukattiv għall-professjonisti tal-kura tas-saħħa għandu jiġu miftiehem mal-Awtoritajiet Nazzjonali Kompetenti qabel ma jitqassam u għandu jkun jikkonsisti mill-komponenti li ġejjin: