FrancophonIA/ELRC3.0 huggingface dataset:
English: Individuals with atopic dermatitis developed more local and general symptoms after vaccination (see section 4.8)
Maltese: Individwi b'dermatite atopika żviluppaw iktar sintomi lokali u ġenerali wara t-tilqima (ara sezzjoni 4.8)
English: The other ingredients are: trometamol, sodium chloride, and water for injections.
Maltese: Is-sustanzi l-oħra huma: trometamol, sodium chloride u ilma għall-injezzjonijiet.
English: One dose (0.5 ml) contains:
Maltese: U KWANTITATTIVA Doża waħda (0.5 mL) fiha:
English: A dose of 0.5 ml is withdrawn into a syringe for injection.
Maltese: Doża ta' 0.5 mL tinġibed ġo siringa għall-injezzjoni.
English: Store in a freezer (at -20°C +/-5°C or -50°C +/-10°C or -80°C +/-10°C).
Maltese: Aħżen fil-friża (f'temperatura ta' -20°C +/-5°C jew -50°C +/-10°C jew -80°C +/-10°C).
English: Seroconversion by ELISA and PRNT were as follows:
Maltese: Rati ta' serokonverżjoni skont ELISA u PRNT kienu kif ġej:
English: Lower immune response data have been observed in HIV infected individuals compared to healthy individuals (see section 5.1).
Maltese: Dejta ta' rispons immuni iktar baxx ġiet osservata f'individwi infettati bl-HIV meta mqabbla ma' individwi b'saħħithom (ara sezzjoni 5.1).
English: Pharmacotherapeutic group: Vaccine, other viral vaccines, ATC code: J07BX
Maltese: Tilqima, tilqim virali ieħor, Kodiċi ATC:
English: Rare (may affect up to 1 in 1000 people):
Maltese: Rari (jistgħu jaffettwaw sa 1 persuna minn kull 1,000):
English: The protective efficacy of IMVANEX against smallpox has not been studied.
Maltese: L-effikaċja protettiva ta' IMVANEX kontra l-ġidri ma ġietx studjata.
English: Muscle spasms Musculoskeletal pain Muscular weakness
Maltese: Uġigħ muskoluskeletriku
English: Dizziness Paresthesia
Maltese: Sturdament Parestesija
English: Imvanex was compared to ACAM2000 (a 'second generation' live attenuated smallpox vaccine produced in cell culture and licenced in the United States of America) in a randomized, open-label non-inferiority clinical trial in healthy adults (US military personnel) aged 18 to 42 years and who were naïve to smallpox vaccine (Study POX-MVA-006).
Maltese: Dan l-istudju sar f'adulti b'saħħithom (membri militari tal-Istati Uniti) b'età ta' 18 sa 42 sena u li qatt ma rċevew tilqim kontra l-ġidri qabel (Studju POXMVA-006).
English: These symptoms may be a sign of a serious allergic reaction.
Maltese: Dawn is-sintomi jista' jkun sinjal ta' reazzjoni allerġika serja.
English: GMT (95% CI)
Maltese: (95% CI)
English: Expiry date depends on storage temperature.
Maltese: Id-data ta' skadenza tiddependi fuq it-temperatura tal-ħażna.
English: (≥1/100 to <1/10)
Maltese: Komuni (≥ 1/100 sa < 1/10)
English: {MM/YYYY}
Maltese: Żieda fi
English: POX-MVA-0083 Healthy 194 12.5 (8.1, 18.2) 85.4 (79.6, 90.1) 98.5 (95.5, 99.7)
Maltese: B'saħħtu 194 12.5 (8.1, 18.2) AD 257 22.9 (17.8, 28.6)
English: If you already have atopic dermatitis, you may experience more intense local skin reactions (such as redness, swelling and itching) and other general symptoms (such as headache, muscle pain, feeling sick or tired), as well as a flare-up or worsening of your skin condition.
Maltese: Jekk diġà għandek dermatite atopika, jista' jkollok reazzjonijiet lokali tal-ġilda iktar intensi (bħal ħmura, nefħa u ħakk) u sintomi ġenerali oħrajn (bħal uġigħ ta' ras, uġigħ fil-muskoli, dardir jew għeja), kif ukoll bħal aggravament f'daqqa jew aggravament tal-kundizzjoni tal-ġilda tiegħek.
English: • increase of cardiac laboratory values (like Troponin I ), liver enzyme increased, white blood cell count decreased, mean platelet volume decreased
Maltese: • żieda tal-valuri kardijaċi tal-laboratorju tal-qalb (bħal Troponin I), żieda fl-enzimi tal-fwied, tnaqqis fl-għadd taċ-ċelluli tad-demm bojod, tnaqqis fil-volum medju tal-plejtlits,
English: POX-MVA-0112 Healthy 88 29.6 (20.0, 40.8) 83.7 (74.2, 90.8) 98.7 (93.1, 100)
Maltese: B'saħħtu 88 29.6 (20.0, 40.8) HIV 351 29.2 (24
English: • diarrhoea, vomiting, abdominal pain, dry mouth,
Maltese: • dijarea, rimettar, uġigħ addominali, ħalq xott,
English: • chills,
Maltese: • ngħas
English: Common (≥1/100 to <1/10) Uncommon (≥1/1,000 to <1/100) Rare (≥1/10,000 to <1/1,000)
Maltese: Rari (≥1/10,000 sa <1/1,000)
English: The second co-primary endpoint evaluated if vaccination with Imvanex (n = 165) prior to administration of ACAM2000 results in an attenuation of the cutaneous reaction to ACAM2000 (n = 161) as measured by maximum lesion area in mm2.
Maltese: It-tieni punt finali ko-primarju evalwa jekk tilqima b'IMVANEX (n = 165) qabel l-għoti ta' ACAM2000 wasslitx għal tnaqqis tar-reazzjoni tal-ġilda għal ACAM2000
English: Troponin I increased Hepatic enzyme increased
Maltese: Żieda fl-enzimi epatiċi
English: How IMVANEX is given 4.
Maltese: Kif jingħata IMVANEX 4.
English: Exp. (-20°C +/-5°C): Exp. (-50°C +/-10°C): Exp. (-80°C +/-10°C):
Maltese: EXP (-80°C +/-10°C):
English: The most common adverse reactions observed in clinical trials were injection site reactions and common systemic reactions typical for vaccines which were mild to moderate in intensity and resolved without intervention within seven days following vaccination.
Maltese: L-iktar reazzjonijiet avversi komuni osservati fil-provi kliniċi kienu reazzjonijiet fis-sit tal-injezzjoni u reazzjonijiet sistemiċi komuni tipiċi għal tilqim li kienu minn ħfief sa moderati fl-intensità, u li fiequ mingħajr intervent fi żmien sebat ijiem wara t-tilqima.
English: Adverse reaction rates reported after either vaccination dose (1st, 2nd or booster) were similar.
Maltese: Ir-rati ta' reazzjonijiet avversi rrappurtati wara kwalunkwe waħda mid-dożi tat-tilqim (l-1, it-2 jew booster) kienu simili.
English: Rigor/Chills Injection site nodule Injection site discolouration Injection site haematoma Injection site warmth
Maltese: Il-professjonisti dwar il-kura tas-saħħa huma mitluba jirrappurtaw kwalunkwe reazzjoni avversa suspettata permezz tas-sistema ta' rappurtar nazzjonali imniżżla f'Appendiċi V.
English: Events of rash after vaccination (related cases observed in 0.4% of subjects) with IMVANEX tend to occur within the first days after vaccination, are mild to moderate in intensity and usually resolve without sequelae.
Maltese: Avvenimenti ta' raxx wara t-tilqima (każijiet relatati osservati f'0.4% tal-individwi) b'IMVANEX għandhom it-tendenza li jseħħu matul l-ewwel jiem wara t-tilqima, u jkunu minn ħfief sa moderati fl-intensità u ġeneralment ifiequ mingħajr l-ebda kundizzjoni jew mard b'konsegwenza tagħhom.
English: • aching muscles,
Maltese: • bugħawwieġ tal-muskoli,
English: The European Medicines Agency has deferred the obligation to submit the results of studies with IMVANEX in all subsets of the paediatric population for prevention of smallpox infection by active immunisation against smallpox infection and disease (see section 4.2 for information on paediatric use).
Maltese: L-Aġenzija Ewropea għall-Mediċini iddifferiet l-obbligu li jiġu ppreżentati riżultati tal-istudji b'IMVANEX f'wieħed jew iktar settijiet tal-popolazzjoni pedjatrika fil-prevenzjoni ta' infezzjoni bil-ġidri permezz ta' tilqima attiva kontra infezzjoni u mard tal-ġidri (ara sezzjoni 4.2 għal informazzjoni dwar l-użu pedjatriku).
English: IMVANEX does not contain smallpox virus (Variola) and cannot spread or cause smallpox.
Maltese: IMVANEX ma fihx il-virus tal-ġidri (Variola) u ma jistax jinfirex jew jikkawża l-ġidri.
English: Store in a freezer (at -20°C +/-5°C or -50°C +/-10°C or -80°C +/-10°C) protected from light.
Maltese: Aħżen fil-friża (f'temperatura ta' -20°C +/-5°C jew -50°C +/-10°C jew -80°C +/-10°C) u pproteġi mid-dawl.
English: • tiredness,
Maltese: • urtikarja (ħorriqija),
English: Seroconversion rates in Vaccinia-naïve individuals were defined as appearance of antibody titers equal or greater than the assay cut-off value following receipt of two doses of IMVANEX.
Maltese: Serokonverżjoni f'individwi li fil-passat ingħataw Vaccinia ġiet definita bħala żieda mill-inqas id-doppju fittitres bażi wara tilqima waħda b'IMVANEX.
English: Talk to your doctor or nurse before receiving IMVANEX:
Maltese: M'għandekx tirċievi IMVANEX:
English: Pale milky coloured homogeneous suspension.
Maltese: Eżamina viżwalment is-suspensjoni qabel l-għoti.
English: IMVANEX should not be administered by intravascular injection.
Maltese: IMVANEX m'għandux jingħata permezz ta' injezzjoni intravaskulari.
English: As seen with traditional smallpox vaccines, a significant reduction in both mortality and morbidity (viral load, weight loss, number of pox lesions, etc.) compared to non-vaccinated controls was demonstrated for NHP vaccinated with IMVANEX.
Maltese: Kif ġie osservat b'tilqim tradizzjonali kontra l-ġidri, intwera tnaqqis sinifikanti kemm fil-mortalità kif ukoll fil-morbożità (ammont virali, telf ta' piż, numru ta' leżjonijiet tal-ġidri, eċċ) meta mqabbla ma' kontrolli mhux imlaqqma għal NHP imlaqqma b'IMVANEX.
English: A total of 433 subjects were randomized in a 1 : 1 ratio to receive either two doses of Imvanex followed by a single dose of ACAM2000 at four weeks intervals or to receive a single dose of ACAM2000.
Maltese: Total ta' 433 individwu kienu magħżula b'mod każwali fi proporzjon ta' 1 : 1 biex jirċievu żewġ dożi ta' IMVANEX segwiti minn doża waħda ta' ACAM2000 f'intervalli ta' erba' ġimgħat jew biex jirċievu doża waħda ta' ACAM2000.
English: 5 years at -50°C +/-10°C
Maltese: JIS (-50°C +/-10°C):
English: • bleeding, irritation, scaling, inflammation, abnormal skin sensation, reaction at the injection iste,
Maltese: • ħruġ ta' demm, irritazzjoni, qoxra, infjammazzjoni, tħoss li l-ġilda ma tkunx normali, reazzjoni fis sit tal-injezzjoni,
English: 1Day 0 corresponding to day of vaccination with IMVANEX; Day 7/14 corresponding to 1 or 2 weeks after vaccination with IMVANEX (first post vaccination analysis at Day 7 in study POX-MVA-011, and at Day 14 in studies POX-MVA-005 and POX-MVA-024); Day 28 corresponding to 4 weeks after vaccination with IMVANEX; SCR = Seroconversion rate; 2 Full Analysis Set (FAS).
Maltese: 1Jum 0 li jikkorrispondi għall-jum tat-tilqima b'IMVANEX (pre-booster); Jum 7 u 14 li jikkorrispondu għal ġimgħa jew ġimagħtejn wara t-tilqima b'IMVANEX; N = numru ta' individwi fil-grupp tal-istudju speċifiku;
English: Injection site haemorrhage Injection site irritation Flushing
Maltese: M'hemmx dejta dwar ir-rispons immuni għal IMVANEX f'individwi immunosoppressi oħrajn.
English: • pink eye,
Maltese: • għajn roża,
English: • sweating,
Maltese: • deni,
English: Hyperhidrosis Ecchymosis Night sweats Subcutaneous nodule Angioedema
Maltese: IMVANEX ikkawża l-ogħla titer ġeometriku medju (GMTgeometric mean titer) ta' antikorp newtralizzanti ta' 153.5
English: Injection site rash Oedema peripheral Asthenia
Maltese: Raxx fis-sit talinjezzjoni Edima periferali Astenja
English: AD 257 5.6 (3.1, 9.3)
Maltese: B'saħħtu 194 5.4 (2.6, 9.8) AD 257 5.6 (3.1, 9.3)
English: Limited data on long-term immunogenicity covering a period of 24 months following primary vaccination of Vaccinia-naïve individuals with IMVANEX are currently available as shown below:
Maltese: Dejta limitata dwar l-immunoġeniċità fit-tul li tkopri perijodu ta' 24 xahar wara t-tilqima primarja b'IMVANEX ta' individwi li fil-passat qatt ma ngħataw Vaccinia, bħalissa hi disponibbli kif muri hawn taħt:
English: Immunocompromised patients (e.g. HIV infected, patients under immunosuppressive therapy) who have been previously vaccinated against smallpox should receive two booster doses.
Maltese: Pazjenti immunokompromessi (eż. pazjenti infettati bl-HIV, pazjenti li jkunu qed jirċievu terapija immunosoppressiva) li fil-passat irċivew tilqima kontra l-ġidri, għandhom jirċievu żewġ dożi booster.
English: Study status N SCR % SCR % (95% CI)
Maltese: Studju saħħa N SCR % SCR %
English: Other medicines or vaccines and IMVANEX
Maltese: Kif taħżen IMVANEX
English: Adverse reactions from all clinical trials are listed according to the following frequency:
Maltese: Reazzjonijiet avversi mill-provi kliniċi kollha huma elenkati skont il-frekwenza li ġejja:
English: Injection site inflammation Injection site paraesthesia Injection site reaction movement impairment Influenza like illness Injection site vesicles
Maltese: • infezzjoni fl-imnieħer u fil-gerżuma, infezzjoni fin-naħa ta' fuq tal-apparat respiratorju,
English: • rash, itch, skin inflammation, skin discolouration,
Maltese: • raxx, ħakk, infjammazzjoni tal-ġilda, tibdil fil-kulur tal-ġilda,
English: The vaccine will be injected under the skin, preferably into the upper arm, by your doctor or a nurse.
Maltese: It-tilqima se tiġi injettata taħt il-ġilda, preferibbilment fil-parti ta' fuq tad-driegħ, mit-tabib jew l-infermier tiegħek.
English: 1Produced in chick-embryo cells
Maltese: Kif jidher IMVANEX u l-kontenut tal-pakkett
English: 5 years at -80°C +/-10°C
Maltese: JIS (-80°C +/-10°C):
English: N/A5
Maltese: ANNESS III
English: Lymphadenopathy
Maltese: TAL-PRODOTT MEDIĊINALI
English: What you need to know before you receive IMVANEX 3.
Maltese: X'għandek tkun taf qabel ma tirċievi IMVANEX 3.
English: The concomitant administration of the vaccine with any immunoglobulin including Vaccinia Immune Globulin (VIG) has not been studied and should be avoided.
Maltese: L-għoti fl-istess ħin tal-tilqima ma' kwalunkwe immunoglobulin li jinkludi Vaccinia Immune Globulin (VIG) ma ġiex studjat u għandu jiġi evitat.
English: Suspension for injection.
Maltese: U KONTENUT Suspensjoni għall-injezzjoni.
English: Vertigo
Maltese: Dermatite
English: IMVANEX should be avoided during breastfeeding unless it is considered that the possible benefit in terms of preventing smallpox would outweigh the potential risk.
Maltese: IMVANEX għandu jiġi evitat waqt it-treddigħ ħlief jekk jiġi kkunsidrat li l-benefiċċju possibbli f'termini ta' prevenzjoni tal-ġidri jkun jegħleb ir-riskju potenzjali.
English: This being an approval under exceptional circumstances and pursuant to Article 14(8) of Regulation (EC) No 726/2004, the MAH shall complete, within the stated timeframe, the following measures:
Maltese: Peress li din hi approvazzjoni taħt ċirkustanzi eċċezzjonali u skont l-Artikolu 14(8) tar-Regolament (KE) 726/2004, l-MAH għandu jtemm, fiż-żmien stipulat, il-miżuri li gejjin:
English: As a precautionary measure the use of IMVANEX should be avoided during pregnancy unless it is considered that the possible benefit in terms of preventing smallpox would outweigh the potential risk.
Maltese: Madankollu, it-tabib tiegħek se jevalwa jekk il-benefiċċju possibbli f'termini ta' prevenzjoni tal-ġidri ikunx ikbar mir-riskji potenzjali li inti tingħata din it-tilqima.
English: Cough
Maltese: KUNJETT
English: Pain in extremity Arthralgia
Maltese: Uġigħ flestremitajiet Artralġja
English: IMVANEX may trigger local rashes or more widespread eruptions.
Maltese: IMVANEX jista' jikkawża raxx lokali jew eruzzjonijiet tal-ġilda iktar mifruxin.
English: *represents seropositivity rates
Maltese: *jirrappreżenta rati ta' seropożittività.
English: Dermatitis Skin discolouration
Maltese: Spażmi talmuskoli
English: ACAM2000 was administered via scarification.
Maltese: ACAM2000 ingħata permezz ta' skarifikazzjoni (qata' fil-ġilda).
English: Other information about Optruma:
Maltese: Informazzjoni oħra dwar Optruma:
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) OPTRUMA EPAR summary for the public
Maltese: RAPPORT TA' VALUTAZZJONI PUBBLIKA EWROPEW (EPAR) OPTRUMA Sommarju tal-EPAR għall-pubbliku
English: Optruma is a medicine containing the active substance raloxifene hydrochloride.
Maltese: Optruma huwa mediċina li fiha s-sustanza attiva raloxifene kloridrat (hydrochloride).
English: The marketing authorisation was renewed on 5 August 2003 and on 5 August 2008.
Maltese: L-awtorizzazzjoni għat-tqegħid fis-suq ġiet imġedda fil-5 ta' Awwissu 2003 u fil-5 ta' Awwissu 2008.
English: The active substance in Optruma, raloxifene, is a selective oestrogen receptor modulator (SERM).
Maltese: Is-sustanza attiva f'Optruma, raloxifene, hija modulatur selettiv tar-riċettur tal-estroġenu (SERM).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Optruma to Eli Lilly Nederland B.V. on 5 August 1998.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fuq is-suq fl-Unjoni Ewropea kollha għal Optruma lil Eli Lilly Nederland B.V. fil-5 ta' Awwissu 1998.
English: Over four years, in comparison with placebo, Optruma decreased the number of new vertebral fractures by 46% in women who had osteoporosis and by 32% in women who had osteoporosis and an existing fracture.
Maltese: Fuq erba' snin, meta mqabbel mal-plaċebo, Optruma naqqas in-numru ta' ksur vertebrali ġodda b'46% f'nisa li jbatu mill-osteoporożi u bi 32% f'nisa li jbatu mill-osteoporożi u ksur eżistenti.
English: What is Optruma?
Maltese: X'inhu Optruma?
English: Three studies looked at the prevention of osteoporosis in 1,764 women, who took either Optruma or placebo (a dummy treatment) for two years.
Maltese: Tliet studji eżaminaw il-prevenzjoni tal-osteoporożi f'1,764 mara ttrattati b'Optruma jew bil-plaċebo (trattament finta) għal sentejn.
English: The fourth study compared the effects of Optruma with those of placebo in the treatment of osteoporosis in 7,705 women over four years.
Maltese: Ir-raba' studju qabbel l-effetti ta' Optruma ma' dawn ta' plaċebo fit-trattament tal-osteoporożi f'7,705 nisa fuq erba' snin.
English: What is the risk associated with Optruma?
Maltese: X'inhu r-riskju assoċjat ma' Optruma?
English: The most common side effects with Optruma (seen in more than 1 patient in 10) are vasodilation (hot flushes) and flu-like symptoms.
Maltese: L-aktar effetti sekondarji komuni ma' Optruma (li jidhru f'aktar minn pazjent 1 minn kull 100) huma ttwessigħ tal-arterji u tal-vini (vasodilation) (fwawar) u sintomi simili għal dawk tal-influwenza.
English: Optruma has been studied in the treatment and in the prevention of osteoporosis in four main studies.
Maltese: Optruma ġie studjat fit-trattament u fil-prevenzjoni tal-osteoporożi f'erba' studji prinċipali.
English: In the prevention of osteoporosis, women receiving Optruma had an increase in bone density in the hip or spine of 1.6% over two years, and those receiving placebo had a decrease of 0.8%.
Maltese: Fil-prevenzjoni tal-osteoporożi, in-nisa ttrattati b'Optruma kellhom żieda fid-densità tal-għadam filġenbejn jew fis-sinsla tad-dahar ta' 1.6% fuq sentejn, u dawk ittrattati bil-plaċebo kellhom tnaqqis ta'
English: Why has Optruma been approved?
Maltese: Għaliex ġie approvat Optruma?
English: How has Optruma been studied?
Maltese: Kif ġie studjat Optruma?
English: Optruma was more effective than placebo in preventing and treating osteoporosis.
Maltese: Optruma rriżulta aktar effikaċi mill-plaċebo fil-prevenzjoni u fit-trattament tal-osteoporożi.
English: The Committee for Medicinal Products for Human Use (CHMP) concluded that Optruma had shown its effectiveness in preventing and treating osteoporosis, and had no effects on the breast or womb.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) ikkonkluda li Optruma wera leffikaċja tiegħu fil-prevenzjoni u fit-trattament tal-osteoporożi, u ma kellu ebda effett fuq is-sider jew fuq il-ġuf.
English: Raloxifene acts as an ‘agonist' of the oestrogen receptor (a substance that stimulates the receptor for oestrogen) in some tissues in the body.
Maltese: Raloxifene jaġixxi bħala 'agonista' tar-riċettur tal-estroġenu (sustanza li tistimula r-riċettur għal estroġenu) f'xi tessuti fil-ġisem.
English: • have liver disease, severe kidney disease, unexplained bleeding from the womb or endometrial cancer (cancer of the lining of the womb).
Maltese: • għandhom marda fil-fwied, marda serja fil-kliewi, fsada mingħajr raġuni mill-ġuf jew kanċer tal endometriju (kanċer tal-inforra tal-ġuf).
English: When used to treat osteoporosis, Optruma was more effective than placebo in reducing the number of vertebral fractures.
Maltese: Meta użat fit-trattament tal-osteoporożi, Optruma rriżulta aktar effikaċi mill-plaċebo fit-tnaqqis tannumru ta' ksur vertebrali.
English: How does Optruma work?
Maltese: Kif jintuża Optruma?
English: What benefit has Optruma shown during the studies?
Maltese: Liema benefiċċju wera Optruma waqt l-istudji mwettqa?
English: How is Optruma used?
Maltese: Għal xiex jintuża Optruma?
English: Osteoporosis is more common in women after the menopause, when the levels of the female hormone oestrogen fall: oestrogen slows down bone breakdown and makes the bones less likely to fracture.
Maltese: L-osteoporożi hija aktar komuni fin-nisa li għaddew mill-menopawża minħabba t-tnaqqis tallivelli tal-estroġeni: l-estroġenu jnaqqas it-tkissir tal-għadam u jagħmel l-għadam inqas suxxettibbli għall-ksur.
English: It is available as triangular tablets (pink: 4 mg rosiglitazone and 4 mg glimepiride; red: 8 mg rosiglitazone and 4 mg
Maltese: Huwa disponibbli bħala pilloli f'forma ta' trijangolu (roża: 4 mg rosiglitazone u 4 mg glimepiride; ħomor: 8 mg rosiglitazone u 4 mg glimepiride).
English: 4-mg/4-mg tablet.
Maltese: Id-doża inizjali hija pillola ta' 4-mg/4-mg.
English: This summary was last updated in 04-2010.
Maltese: Dan is-sommarju kien aġġornat l-aħħar fi 04-2010.
English: • glimepiride is a sulphonylurea: it stimulates the pancreas to produce more insulin.
Maltese: • glimepiride hija sulfonilurea: tistimula l-frixa biex tipproduċi aktar insulina.
English: The European Commission granted a marketing authorisation valid throughout the EU for Avaglim to Smithkline Beecham Ltd. on 27 June 2006.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Avaglim lil Smithkline Beecham Ltd fis-27 ta' Ġunju 2006.
English: This document is a summary of the European Public Assessment Report (EPAR) for Avaglim.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Avaglim.
English: Avaglim is a medicine that contains two active substances, rosiglitazone and glimepiride.
Maltese: Avaglim huwa mediċina li fiha żewġ sustanzi attivi, rosiglitazone u glimepiride.
English: Glimepiride has been available in
Maltese: Avaglim rosiglitazone u glimepiride
English: Rosiglitazone has been authorised in the European Union (EU) as Avandia since 2000.
Maltese: Glimepiride ilu disponibbli fl-UE sa mill-1995.
English: It must not be used in patients who have heart failure (an inability of the heart to pump enough blood around the body), an ‘acute coronary syndrome' such as unstable angina (a severe type of chest pain that changes in intensity) or certain types of heart attack, problems with their liver, severe problems with their kidneys, type 1 diabetes, or complications of diabetes (diabetic ketoacidosis or diabetic coma).
Maltese: Ma għandux jintuża f'pazjenti li jkollhom insuffiċjenza kardijaka (inabilità tal-qalb li tippompja biżżejjed demm madwar il-ġisem), 'sindromu koronarju akut' bħal anġina instabbli (tip gravi ta' wġigħ fis-sider li l-intensità tiegħu tinbidel) jew ċerti tipi ta' attakk tal-qalb, problemi bil-fwied, problemi gravi bil-kliewi, dijabete tat-tip 1, jew kumplikazzjonijiet relatati mad-dijabete (ketoaċidożi djabetika jew koma djabetika).
English: The patient can start with separate tablets containing only rosiglitazone or a sulphonylurea, before switching to the combination tablet once control is achieved.
Maltese: It-terapija tista' tinbeda b'pilloli separati li fihom rosiglitazone jew sulfonilurea biss u, wara li jiksbu lkontroll, jaqilbu għall-pillola li fiha l-kombinazzjoni.
English: Why has Avaglim been approved?
Maltese: Għaliex ġie approvat Avaglim?
English: The most common side effects with Avaglim (seen in more than 1 patient in 10) are hypoglycaemia and oedema (swelling).
Maltese: L-aktar effetti sekondarji komuni b'Avaglim (li dehru f'aktar minn pazjent 1 minn 10) huma ipogliċemija u edema (nefħa).
English: Avaglim is used to treat adults who have type 2 diabetes.
Maltese: Avaglim jintuża għat-trattament ta' adulti li jbatu mid-dijabete ta' tip 2.
English: For glimepiride, the information came from
Maltese: Għal glimepiride, l-informazzjoni waslet minn pubblikazzjonijiet xjentifiċi.
English: How does Avaglim work?
Maltese: X'inhu Avaglim?