FrancophonIA/ELRC3.0 huggingface dataset:
English: RISPERDAL CONSTA is indicated for the maintenance treatment of schizophrenia in patients currently stabilised with oral antipsychotics.
Maltese: RISPERDAL CONSTA huwa indikat għall-manteniment ta' kura ta' skizofrenja f'pazjenti li bħalissa huma stabilizzati b'antipsikotiċi mill-ħalq.
English: Priapism Psychiatric disorders Very common Depression, Insomnia, Anxiety Common
Maltese: Komuni ħafna Depressjoni, Insomnja, Ansjetà Komuni
English: RISPOLEPT® CONSTA® Liechtenstein:
Maltese: Liechtenstein:
English: Dyspnoea, Cough, Nasal congestion, Pharyngolaryngeal pain
Maltese: • Żieda fil-piż, uġigħ tas-snien, tnaqqis fil-piż
English: HOW TO USE RISPERDAL CONSTA
Maltese: RISPERDAL CONSTA
English: Although extensive metabolisers have lower risperidone and higher 9-hydroxy-risperidone concentrations than poor metabolisers, the pharmacokinetics of risperidone and 9-hydroxy-risperidone combined (i.e., the active antipsychotic fraction), after single and multiple doses, are similar in extensive and poor metabolisers of CYP 2D6.
Maltese: Minkejja li metabolizzaturi estensivi jkollhom konċentrazzjonijiet ta' risperidone aktar baxxi u ta' 9-hydroxy-risperidone aktar għoljin minn metabolizzaturi nieqsa, ilfarmakokinetika ta' risperidone u ta' 9-hydroxy-risperidone flimkien (i.e., il-porzjon antipsikotiku attiv), wara doża waħda u ħafna dożi, jixtiebhu f'metabolizzatturi estensivi u nieqsa ta' CYP 2D6.
English: • Flushing, oily skin inflammation, dandruff, rash all over the body
Maltese: • Fwawar, infjammazzjoni f'ġilda żejtnija, brija, raxx mifrux mal-ġisem kollu
English: RISPERDAL CONSTA and associated names (see Annex I) 50 mg powder for prolonged-release suspension for intramuscular injection risperidone
Maltese: RISPERDAL CONSTA u ismijiet assoċjati miegħu (ara Anness I) 50 mg trab u solvent għal suspensjoni li jerħi l-mediċina bil-mod għall-injezzjoni ġol-muskolu
English: This was reflected in the harmonised wording of the SPC, along with the statement “The efficacy of the 12.5 mg dose has not been investigated in clinical trials”.
Maltese: L-effikaċja taddoża ta' 12.5mg ma ġietx investigata fi provi kliniċi.
English: Absorption The absorption of risperidone from RISPERDAL CONSTA is complete.
Maltese: Assorbiment L-assorbiment ta' risperidone minn RISPERDAL CONSTA huwa komplut.
English: RISPERDAL CONSTA and associated names (see Annex I) 37.5 mg powder for prolonged-release suspension for intramuscular injection
Maltese: RISPERDAL CONSTA u ismijiet assoċjati miegħu (ara Anness I) 37.5 mg ta' trab għal suspensjoni li tintreħa bil-mod għal injezzjoni għal ġol-muskolu
English: The mechanism underlying the renal tumours in RISPERDAL CONSTA-treated male Wistar (Hannover) rats is unknown.
Maltese: Il-bażi tal-mekkaniżmu tat-tumuri renali f'firien irġiel Wistar (Hannover) ikkurati b'RISPERDAL CONSTA m'huwiex magħruf.
English: The CHMP also assessed the proposed 12.5 mg dosing, in particular with regards to the elderly population, and considered that the 12.5 mg dose of Risperdal Consta would provide additional dosing flexibility but stressed that this dose is intended only as a lower initial dose to establish tolerability, to be used mainly for patients with a higher sensitivity to the effects of the drug, either because of reduced metabolism/excretion, or in patients with an intrinsic lower tolerability to psychotropic medication.
Maltese: Is-CHMP ivvaluta ukoll l-iddożar propost ta' 12.5 mg, b'mod partikolari fir-rigward tal-popolazzjoni anzjana, u kkunsidra li doża ta' 12.5 mg ta' Risperdal Consta tipprovdi flessibilità addizzjonali ta' liddożar iżda enfassizza li din id-doża hija biss intenzjonata bħala doża inizjali iktar baxxa biex tistabbilixxi t-tollerabbilità, biex tintuża prinċipalment f'pazjenti b'sensittività ogħla għall-effetti talmediċina, jew minħabba metaboliżmu/eliminazzjoni mnaqqsin, jew f'pazjenti b'tollerabbilità intrinsika iktar baxxa għall-medikazzjoni psikotropika.
English: Your doctor will choose RISPERDAL CONSTA 25 mg or 37.5 mg.
Maltese: It-tabib tiegħek jagħżel RISPERDAL CONSTA 25 mg jew 37.5 mg.
English: Hyperprolactinaemia
Maltese: L-Isvezja injezzjoni
English: sleepiness
Maltese: Suffejra
English: The MAH presented a table summarising the results of total PANSS score from RIS-INT-61, broken down by dose level for the dose groups 25 mg, 50 mg and 75 mg. Two additional tables provided data showing that treatment is non-inferior to risperidone oral treatment for the changes in positive and negative symptoms subscales of PANSS.
Maltese: Il-MAH ippreżenta tabella li tiġbor fil-qosor ir-riżultati ta' skor totali ta' PANSS minn RIS-INT-61, imqassam b'livell ta' doża għall-gruppi ta' doża ta' 25 mg, 50 mg u 75 mg.
English: RISPERDAL CONSTA and associated names (see Annex I) 25 mg powder and solvent for prolongedrelease suspension for intramuscular injection
Maltese: RISPERDAL CONSTA u ismijiet assoċjati miegħu (ara Anness I) 25 mg trab u solvent għal suspensjoni li jerħi l-mediċina bil-mod għall-injezzjoni ġol-muskolu
English: RISPERDAL CONSTA extended release microspheres in the vial must be reconstituted only in the solvent in the syringesupplied in the dose pack, and must be administered only with the Needle-Pro safety needle supplied in the dose pack.
Maltese: Mikrosferi RISPERDAL CONSTA li jintreħew bil-mod li qegħdin fil-kunjett għandhom jiġu rikostitwiti biss fis-solvent ta' ġos-siringa pprovduta fil-pakkett tad-doża, u għandu jingħata biss billabra ta' sigurtà Needle-Pro pprovduta fil-pakkett tad-doża.
English: Higher active antipsychotic fraction plasma concentrations and a reduced clearance of the active antipsychotic fraction by on average 60% were observed in patients with renal insufficiency.
Maltese: Konċentrazzjonijiet ogħla tal-porzjon antipsikotiku attiv fil-plażma u tnaqqis fit-tneħħija tal-porzjon antipsikotiku attiv b'medja ta' 60% kienu osservati f'pazjenti b'insuffiċjenza renali.
English: • Very hard feces, fecal incontinence, abdominal discomfort, thirst, lip swelling, inflammation of the colon, reduced saliva
Maltese: • Ippurgar iebes ħafna, inkontinenza ta' l-ippurgar, skomfort fl-addome, għatx, nefħa fix-xufftejn,
English: Physicians should weigh the risks versus the benefits when prescribing antipsychotics, including RISPERDAL CONSTA, to patients with Parkinson's Disease or Dementia with Lewy Bodies (DLB).
Maltese: It-tobba għandhom iqisu r-riskji u l-benefiċċji meta jagħtu antipsikotiċi, inkluż RISPERDAL CONSTA, lill-pazjenti bil-Marda ta' Parkinson jew Dimenzja bil-Korpi Lewy (DLB) ) il-Marda ta' Parkinson tista' tmur għall-agħar b'risperidone.
English: RISPERDAL CONSTA can lower blood pressure
Maltese: RISPERDAL CONSTA jista' jikkawża pressjoni baxxa.
English: The MAH provided further justifications, being of the position that restricting the use of Risperdal Consta to patients with an initial treatment response to oral risperidone would be unjustified and would introduce an unnecessary and potentially prolonged additional step for the prescribing physicians, delaying access of Risperdal Consta to those patients who may not be adherent to their oral medication and who may be among the most suitable candidates for a long-acting injectable medication.
Maltese: Barra minn hekk, risperidone li jaħdem fit-tul joffri vantaġġ f'konformità malkura, li jista' jirriżulta f'livelli iktar stabbli ta' risperidone fil-plażma.
English: Risperidone was not teratogenic in animal studies but other types of reproductive toxicity were seen (see section 5.3).
Maltese: Risperidone ma kienx teratoġeniku fi studji fuq l-annimali iżda ntwerew tipi oħra ta' ħsara fuq is-sistema riproduttiva (ara sezzjoni 5.3).
English: --1 Modified live Porcine Respiratory and Reproductive Syndrome Virus, strain 96V198: 102.2 - 105.2 CCID50* per 2 ml *Cell culture infectious dose 50%
Maltese: --1 Porcine Respiratory and Reproductive Syndrome Virus ħaj modifikat, strejn 96V198: 102.2 - 105.
English: Withdrawal period
Maltese: Tiżmim
English: Further information on Onsior can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: It works by blocking an enzyme called cyclooxygenase 2 (COX-2).
Maltese: Hija taħdem billi timblokka enzima msejħa cyclooxygenase 2 (COX-2).
English: Other information about Onsior:
Maltese: Informazzjoni oħra dwar Onsior:
English: Onsior contains the active substance robenacoxib.
Maltese: Onsior fih is-sustanza attiva robenacoxib.
English: The active substance in Onsior, robenacoxib, belongs to a class of medicines called non-steroidal antiinflammatory drugs (NSAIDs).
Maltese: Is-sustanza attiva f'Onsior, robenacoxib, tappartjeni għal klassi ta' mediċina msejħa prodott antiinfjammatorju non-sterojdali (NSAIDs).
English: Onsior is available as tablets in five different strengths (6 mg for cats and 5 mg, 10 mg, 20 mg, and 40 mg for dogs) and as a solution for injection (20 mg/ml for dogs and cats).
Maltese: Onsior huwa disponibbli f'pilloli ta' ħames dożi differenti (6 mg għall-qtates u 5 mg, 10 mg, 20 mg u 40 mg għall-klieb) kif ukoll bħala soluzzjoni għal injezzjoni (20 mg/ml għall-klieb u l-qtates).
English: In very rare cases, lethargy may be observed.
Maltese: F'każijiet rari ħafna, ġiet osservata wkoll letarġija.
English: Onsior received a marketing authorisation valid throughout the EU on 16 December 2008.
Maltese: Onsior irċieva awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fis-16 ta' Diċembru 2008.
English: What are the risks associated with Onsior?
Maltese: X'inhuma r-riskji assoċjati ma' Onsior?
English: In a clinical study, Onsior tablets increased the activity in 10 of 35 cats with chronic musculoskeletal disorders (as measured by activity monitors on a neck collar) and scores of behaviour, quality of life, temperament and apparent happiness of cats compared to placebo (a dummy treatment).
Maltese: Fi studju kliniku, il-pilloli Onsior żiedu lattività f'10 minn 35 qattus li kienu qed ibatu minn mard muskoloskeletali (kif osservat permezz ta' strumenti għall-monitoraġġ tal-attività fuq kullar mal-għonq) u l-punteġġi tal-imġiba, il-kwalità talħajja, it-temperament u l-kuntentizza apparenti tal-qtates meta mqabbla mal-plaċebo (trattament finta).
English: In cats, Onsior tablets are used to treat pain and inflammation associated with acute (short term) and chronic (long term) musculoskeletal disorders (problems with the muscles and bones) and to reduce moderate pain and inflammation associated with orthopaedic (bone) surgery.
Maltese: Fil-qtates, il-pilloli Onsior jintużaw għat-trattament ta' uġigħ u infjammazzjoni assoċjati ma' mard muskoloskeletali (problemi bil-muskoli u l-għadam) akut (perjodu qasir) u kroniku (perjodu fit-tul)u biex inaqqsu uġigħ moderat u infjammazzjoni assoċjata ma' intervent kirurġiku (fl-għadam).
English: Onsior was as effective as the comparator NSAIDs and more effective than placebo.
Maltese: Onsior kien effettiv daqs l-NSAIDs komparaturi u kien iktar effettiv mill-plaċebo.
English: This enzyme is involved in producing substances called prostaglandins, which are involved in pain and inflammation.
Maltese: Din l-enzima hija involuta fil-produzzjoni tas-sustanzi msejħa prostaglandini, li jistgħu jipproduċu uġigħ u infjammazzjoni.
English: Onsior was as effective as the comparator NSAIDs.
Maltese: Onsior kien effettiv daqs il-komparaturi NSAIDs.
English: Treatment in cats is limited to six days for acute musculoskeletal disorders and longer term for chronic musculoskeletal disorders, with monitoring by the veterinarian.
Maltese: It-trattament fil-qtates huwa limitat għal sitt ijiem fil-każ ta' mard muskoloskeletali akut u għal perjodu itwal fil-każ ta' mard muskoloskeletali kroniku, b'monitoraġġ mill-veterinarju.
English: The tablets are given once a day at the same time every day, at a dose range of 1 - 2.4 mg per kg bodyweight depending on whether one or two tablets are required.
Maltese: Il-pilloli jingħataw darba kuljum fl-istess ħin kuljum, f'firxa ta' dożi li tvarja minn 1 - 2.4 mg għal kull kg ta' piż tal-ġisem skont jekk tkunx meħtieġa pillola waħda jew tnejn.
English: After the end of the operation, sufficient pain control was seen up to 24 hours in dogs and up to 52 hours (2 days) in cats.
Maltese: Wara t-tmiem tal-operazzjoni, ġie osservat biżżejjed kontroll tal-uġigħ fil-klieb sa 24 siegħa u fil-qtates sa 52 siegħa (jumejn).
English: Onsior is an anti-inflammatory veterinary medicine for use in cats and dogs to treat pain and inflammation.
Maltese: Onsior huwa mediċina antiinfjammatorja biex tikkura uġigħ u infjammazzjoni għal użu fil-qtates u lklieb.
English: The solution for injection is given as an injection under the skin to cats or dogs around 30 minutes before the start of the operation at a dose of 2 mg/kg bodyweight.
Maltese: Is-soluzzjoni għal-injezzjoni tingħata lill-qtates jew lill-klieb bħala injezzjoni taħt il-ġilda 30 minuta qabel ma tibda l-operazzjoni f'doża ta' 2 mg għal kull kg ta' piż tal-ġisem.
English: The side effects of Onsior are similar to those seen with other NSAIDs.
Maltese: L-effetti kollaterali ta' Onsior huma simili għal dawk ta' NSAIDs oħrajn.
English: In cats, Onsior tablets reduced moderate pain and inflammation associated with orthopaedic surgery for up to 2 days post operation when compared to animals that received placebo.
Maltese: Fil-qtates, il-pilloli Onsior naqqsu l-uġigħ moderat u l-infjammazzjoni assoċjata ma' intervent kirurġiku sa jumejn wara l-operazzjoni meta mqabbla ma' annimali li ngħataw il-plaċebo.
English: By blocking the production of prostaglandins, robenacoxib reduces the pain and inflammation caused by musculoskeletal disorders, surgery or osteoarthritis.
Maltese: Robenacoxib timblokka l-produzzjoni ta' prostaglandini u għaldaqstant tnaqqas l-uġigħ u l-infjammazzjoni kkawżati minn mard muskoloskeletali, intervent kirurġiku jew osteoartrite.
English: The solution for injection is used to treat pain and inflammation associated with orthopaedic or soft tissue surgery, such as neutering.
Maltese: Issoluzzjoni għal injezzjoni tintuża biex tikkura uġigħ u infjammazzjoni assoċjati ma' intervent kirurġiku ortopediku jew fit-tessut artab, bħal pereżempju kastrazzjoni.
English: How does Onsior work?
Maltese: Kif jintuża Onsior?
English: In cats, the 6-mg tablet and the solution for injection can be used interchangeably when used to reduce pain and inflammation associated with orthopaedic surgery.
Maltese: Fil-qtates, il-pillola ta' 6 mg u s-soluzzjoni għal injezzjoni jistgħu jintużaw it-tnejn b'mod interkambjabbli meta użati biex inaqqsu uġigħ u infjammazzjoni assoċjati ma' intervent kirurġiku.
English: The most common side effects of the tablets and solution for injection are mild and transient effects on the stomach and gut, seen as vomiting, soft faeces and diarrhoea.
Maltese: L-effetti kollaterali l-aktar komuni tal-pilloli u tas-soluzzjoni għal injezzjoni huma effetti dgħajfa u tranżitorji fuq l-istonku u fuq limsaren, li jimmanifestaw ruħhom f'rimettar, ippurgar artab u dijarea.
English: For a full list of side effects of Onsior, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji ta' Onsior, ara l-fuljett ta' tagħrif.
English: Cats should be given a single dose by mouth prior to orthopaedic surgery.
Maltese: Il-qtates għandhom jingħataw doża waħda fil-ħalq qabel intervent kirurġiku ortopediku.
English: 16 December 2016
Maltese: 16 ta' Diċembru 2016
English: Arzerra has been authorised since April 2010.
Maltese: Arzerra ilu awtorizzat minn April 2010.
English: The full European Public Assessment Report for Arzerra can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: On 10 November 2016, the CHMP adopted a positive opinion recommending an extension to this indication: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/001131/smops/Positive/human_smop_ 001049.jsp&mid=WC0b01ac058001d127
Maltese: 1 FL-10 ta' Novembru 2016, is-CHMP adotta opinjoni pożittiva fejn irrakkomanda estensjoni għal din l-indikazzjoni: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/001131/smops/Positive/human_smop_ 001049.jsp&mid=WC0b01ac058001d127
English: What is Arzerra?
Maltese: X'inhu Arzerra?
English: Arzerra was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 7 November 2008 for CLL.
Maltese: Arzerra kien ikklassifikat bħala "mediċina orfni" (mediċina li tintuża f'mard rari) fis7 ta' Novembru 2008 għal CLL.
English: What was Arzerra expected to be used for?
Maltese: Għal xiex kien mistenni li jintuża Arzerra?
English: The active substance in Arzerra, ofatumumab, is a monoclonal antibody, a protein that has been designed to recognise and attach to another protein called CD20 on the surface of lymphocytes, including the cancerous lymphocytes seen in CLL.
Maltese: Is-sustanza attiva f'Arzerra, l-ofatumumab, hija antikorp monoklonali, proteina li tkun tfasslet biex tagħraf u teħel ma' proteina oħra msejħa CD20 fuq il-wiċċ tal-limfoċiti, inklużi l-limfoċiti kanċerużi li jidhru f'CLL.
English: On 8 November 2016, Novartis Europharm Ltd officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for Arzerra to be used in a new combination with bendamustine for the treatment of relapsed chronic lymphocytic leukaemia (CLL).
Maltese: Fit-8 ta' Novembru 2016, Novartis Europharm Ltd għarrfet uffiċjalment lill-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) bl-intenzjoni tagħha li tixtieq tirtira l-applikazzjoni tagħha għall-awtorizzazzjoni għat-tqegħid fis-suq għal Arzerra biex jintuża f'kombinazzjoni ġdida ma' bendamustine għall-kura ta' lewkimja limfoċitika kronika (CLL) li tkun irkadiet.
English: Arzerra is a cancer medicine used to treat adults with chronic lymphocytic leukaemia (CLL), a cancer of a type of white blood cells called lymphocytes.
Maltese: Arzerra huwa mediċina kontra l-kanċer li tintuża għall-kura ta' adulti b'lewkimja limfoċitika kronika (CLL), kanċer ta' tip ta' ċelloli bojod tad-demm imsejħa limfoċiti.
English: Arzerra was also expected to be used in combination with bendamustine to treat adults with relapsed CLL (CLL that came back after previous treatment).
Maltese: Arzerra kien mistenni li jintuża wkoll f'kombinazzjoni ma' bendamustine għall-kura ta' adulti b'CLL li kienet irkadiet (CLL li tkun reġgħet tfaċċat wara kura preċedenti).
English: It is used together with the cancer medicines chlorambucil or bendamustine in previously untreated patients who cannot be given treatment based on another medicine, fludarabine.
Maltese: Jintuża flimkien mal-mediċini kontra l-kanċer chlorambucil jew bendamustine fuq pazjenti li ma jkunux ingħataw kura preċedenti li ma jkunux jistgħu jingħataw kura bbażata fuq mediċina oħra, fludarabine.
English: Additionally, although some patients (39 out of 53) responded to the combination Arzerra plus bendamustine, only a few patients (6 out of 53) had a complete response, and these data were not supported by further study results.
Maltese: Barra minn hekk, għalkemm xi pazjenti (39 minn 53) kienu rrispondew għall-kombinazzjoni ta' Arzerra flimkien ma' bendamustine, ftit biss kienu l-pazjenti (6 minn 53) li kellhom rispons sħiħ, u din id-data ma kinitx appoġġjata minn riżultati ta' studji ulterjuri.
English: The company presented the results from a study involving 53 patients with relapsed CLL.
Maltese: Il-kumpanija ppreżentat ir-riżultati minn studju li fih ħadu sehem 53 pazjent b'CLL li kienet irkadiet.
English: The CHMP was concerned that the study did not compare Arzerra with any other medicine and only included 53 patients with relapsed CLL.
Maltese: Is-CHMP kien imħasseb li l-istudju ma kienx qabbel lil Arzerra ma' xi mediċina oħra u li fih kienu ħadu sehem biss 53 pazjent b'CLL li kienet irkadiet.
English: It contains the active substance ofatumumab and is available as a concentrate that is made up into a solution for infusion (drip) into a vein.
Maltese: Fih is-sustanza attiva ofatumumab u jiġi bħala konċentrat li jsir f'soluzzjoni għall-infużjoni (dripp) ġo vina.
English: By attaching to CD20, ofatumumab stimulates the body's immune system to attack the cancerous cells, helping to control the disease.
Maltese: Billi teħel ma' CD20, l-ofatumumab tistimula lis-sistema immunitarja tal-ġisem biex tattakka ċ-ċelloli kanċerużi, u b'hekk tgħin sabiex tikkontrolla l-marda.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
Maltese: L-ittra tal-irtirar tista' tinstab hawnhekk
English: MA (EU) number (Invented) name
Maltese: Numru ta' l-EU Isem (ivvintat) Qawwa
English: Ελλάδα Amgen Ελλάς Φαρμακευτικά Ε.Π.Ε.
Maltese: Ελλάδα Amgen Ελλάς Φαρμακευτικά ΕΠΕ.
English: Placebo n = 3,906
Maltese: Plaċebo n = 3,906
English: 0-3 years *p < 0.0001, **p < 0.0001 - exploratory analysis
Maltese: 0-3 snin *p < 0.0001, **p < 0.0001 - analiżi esploratorja
English: - The active substance is denosumab.
Maltese: - Is-sustanza attiva hi denosumab.
English: Hypocalcaemia (see section 4.4).
Maltese: Ipokalċimija (ara sezzjoni 4.4).
English: INFORMATION IN BRAILLE Prolia
Maltese: INFORMAZZJONI BIL BRAILLE Prolia
English: Sodium hydroxide (for pH adjustment)* Sorbitol (E420)
Maltese: Sodium hydroxide (għall-aġġustament tal-pH)* Sorbitol (E420)
English: Prolia contains sorbitol
Maltese: Prolia fih sorbitol
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 26 May 2010
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 26 ta' Mejju 2010
English: Rare Rare
Maltese: Rari Rari
English: Subjects with an eGFR < 30 mL/min/1.73 m2 were excluded from the study.
Maltese: Pazjienti b'eGFR< 30 mL/min/1.73 m2 kienu eskludi mill-istudju.
English: 1 See section Description of selected adverse reactions 2 See section 4.4
Maltese: 1Ara s-sezzjoni Deskrizzjoni ta' reazzjonijiet avversi magħżula 2Ara s-sezzjoni 4.4
English: Tél: +33 (0)9 69 363 363
Maltese: Amgen S.A.S Tél: +33 (0)9 69 363 363
English: MARKETING AUTHORISATION NUMBER(S) EU/1/10/618/001 1 pre-filled syringe (blistered) EU/1/10/618/002 1 pre-filled syringe (unblistered) EU/1/10/618/003 1 pre-filled syringe with automatic needle guard (blistered)
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/10/618/001 siringa mimlija għal-lest waħda (fil-folja) EU/1/10/618/002 siringa mimlija għal-lest waħda (mhux fil-folja) EU/1/10/618/003 siringa mimlija għal-lest waħda bi protezzjoni awtomatika tal-labra (fil-folja)
English: Amgen AB Tlf: +47 23308000
Maltese: Tlf: +47 23308000
English: • hair loss (alopecia).
Maltese: • telf tax-xagħar (alopeċja).
English: MedDRA system organ class Frequency category
Maltese: Klassi tas-sistemi u tal-organi MedDRA
English: LIST OF EXCIPIENTS Acetic acid, glacial, sodium hydroxide, sorbitol (E420), polysorbate 20, water for injections.
Maltese: TA' EĊĊIPJENTI Acetic acid, glacial, sodium hydroxide, sorbitol (E420), polysorbate 20, ilma għall-injezzjonijiet.
English: Cellulitis1
Maltese: Ċellulite1
English: • are taking medicines called corticosteroids (such as prednisolone or dexamethasone).
Maltese: • qed tieħu mediċini msejħa kortikosterojdi (bħal prednisolone jew dexamethasone).
English: Prolia contains sodium
Maltese: Prolia fih sodium
English: • cancer, co-morbid conditions (e.g. anaemia, coagulopathies, infection), smoking.
Maltese: • kanċer, kondizzjonijiet ko-morbużi (eż. anemija, tgħaqid tad-demm, infezzjoni), tipjip.
English: Major osteoporotic fracture4 *p ≤ 0.05; **p = 0.0106 (secondary endpoint included in multiplicity adjustment), ***p ≤ 0.0001 + Event rates based on Kaplan-Meier estimates at 3 years.
Maltese: *p ≤ 0.05; **p = 0.0106 (punt finali sekondarju inkluż fl-aġġustament ta' multipliċità), ***p ≤ 0.0001 + Rati ta' avveniment ibbażati fuq stimi Kaplan-Meier wara 3 snin.
English: The subject incidence of non-vertebral fracture was 4.3% (denosumab) versus 2.5% (risedronate).
Maltese: L-inċidenza tas-suġġett ta' ksur mhux vertebrali kienet ta' 4.3% (denosumab) versus 2.5% (risedronate).
English: Very common Very common Rare
Maltese: Komuni ħafna Komuni ħafna Rari