FrancophonIA/ELRC3.0 huggingface dataset:
English: Reminds HCPs to discuss with the patient/care giver the risks of phototoxicity/skin SCC and hepatotoxicity, what to look for, how and when to seek immediate attention.
Maltese: - Ifakkar lil HCPs biex jiddiskutu mal-pazjent/il-persuna li tieħu ħsieb il-pazjent dwar irriskji ta' fototossiċità/SCC tal-ġilda u tossiċità tal-fwied, x'għandek tinnota, kif u meta tfittex attenzjoni immedjata.
English: In vitro studies show that the metabolism of voriconazole may be inhibited by NNRTIs and voriconazole may inhibit the metabolism of NNRTIs.
Maltese: Studji in vitro wrew li l-metaboliżmu ta' voriconazole jista' jitwaqqaf millNNRTIs u voriconazole jista' jwaqqaf il-metaboliżmu tal-NNRTIs.
English: How to store Voriconazole Accord
Maltese: X'fih Voriconazole Accord
English: In the pre- and post-natal development study in rats at exposures lower than those obtained in humans with therapeutic doses, voriconazole prolonged the duration of gestation and labour and produced dystocia with consequent maternal mortality and reduced perinatal survival of pups.
Maltese: Suġġetti li huma metabolizzaturi eterozigoti estensivi għandhom, bħala medja, esponiment għal voriconazole darbtejn ogħla mill-metabolizzaturi emozigoti estensivi.
English: Coadministration of standard doses of voriconazole with efavirenz doses of 400 mg once daily or higher is contraindicated, because efavirenz significantly decreases plasma voriconazole concentrations in healthy subjects at these doses.
Maltese: L-amministrazzjoni ta' dożi standard ta' voriconazole flimkien ma' efavirenz doża ta' 400 mg jew aktar darba kuljum huwa kontraindikat, billi efavirenz inaqqas b'mod sinifikanti l-konċentrazzjonijiet ta' voriconazole fil-plasma f'suġġetti b'saħħithom b'dawn id-dożi.
English: Advises HCPs on the risks of phototoxicity, skin SCC and liver toxicity associated with voriconazole use.
Maltese: - Ifakkar lil HCPs dwar ir-riskji ta' fototossiċità, SCC tal-ġilda u epatotossiċità rrappurtati bl-użu ta' voriconazole.
English: 1 Strains with MIC values above the Susceptible (S) breakpoint are rare, or not yet reported.
Maltese: Evidenza insuffiċjenti 1 Forom b'valuri ta' MIC ‘il fuq mill-breakpoint Suxxettibbli (S) huma rari, jew għadhom ma ġewx irrappurtati.
English: Dose reduction of methadone may be needed.
Maltese: Jista' jkun meħtieġ tnaqqis fid-doża tal-methadone.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/06/352/001-003
Maltese: FIS-SUQ EU/1/06/352/001-003
English: Warner Chilcott Deutschland GmbH Dr.-Otto-Röhm-Strasse 2-4 64331 Weiterstadt Germany
Maltese: Warner Chilcott Deutschland GmbH Dr.-Otto-Röhm-Strasse 2-4 64331 Weiterstadt
English: Intrinsa is used to treat HSDD.
Maltese: Intrinsa jintuża għat-trattament ta' HSDD.
English: MARKETING AUTHORISATION HOLDER Warner Chilcott UK Limited
Maltese: Id-Detentur ta' l-Awtorizzazzjoni għat-tqegħid fis-Suq Warner Chilcott UK Limited
English: Intrinsa did not influence serum concentrations of sex hormone binding globulin (SHBG), estrogens or adrenal hormones.
Maltese: Intrinsa ma nfluwenzax il-konċentrazzjonijiet fis-serum tas-sex hormone binding globulin (SHBG), estroġeni jew ormoni adrenali.
English: Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), or very rare (< 1/10,000), not known (cannot be estimated from the available data).
Maltese: Il-frekwenzi huma definiti bħala: 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), jew rari ħafna (< 1/10,000), mhux magħruf (ma tistax tittieħed stima mid data disponibbli).
English: Fertility No data is available of the effect of Intrinsa on fertility.
Maltese: Fertilità M'hemm l-ebda dejta dwar l-effett ta' Intrinsa fuq il-fertilità.
English: Patients treated with conjugated equine estrogen (CEE) are not recommended to use Intrinsa, as efficacy has not been demonstrated (see sections 4.4 and 5.1).
Maltese: Pazjenti trattati b'conjugated equine estrogen (CEE) mhumiex rakkomandati li jużaw Intrinsa, għax leffikaċja ma ntwerietx (ara sezzjonijiet 4.4 u 5.1).
English: If an adverse reaction occurred at a higher frequency in the integrated phase III studies (Intrinsa patients n=1,498, placebo patients n=1,297), this frequency is reported in the table.
Maltese: Jekk reazzjoni avversa seħħet fi frekwenza ogħla fl-istudji integrati ta' fazi III (pazjenti fuq Intrinsa n=1,498, pazjenti fuq il-plaċebo n=1,297), din il-frekwenza hi rrappurtata fit-tabella.
English: In women, circulating testosterone is primarily bound in the serum to SHBG (65-80 %) and to albumin (20-30 %) leaving only about 0.5-2 % as the free fraction.
Maltese: Distribuzzjoni Fin-nisa, it-testosterone li jiċċirkola jeħel primarjament fis-serum ma' SHBG (65-80%) u ma' l albumina (20-30%), u jħalli biss madwar 0.5-2% bħala l-porzjon ħieles.
English: In the combined phase III data, excluding patients taking oral CEE, in whom there was no significant improvement in sexual function, 50.7 % of women (n=274) treated with Intrinsa and 29.4 % of those treated with placebo (n=269) were responders with regard to total satisfying sexual activity (primary endpoint), when a responder was predefined as having an increase in the 4-week frequency of satisfying activities of > 1.
Maltese: III, li jeskludi l-pazjenti li kienu qed jieħdu CEE orali, li fihom ma kien hemm l-ebda titjib sinifikanti fil-funzjoni sesswali, 50.7% tan-nisa (n=274) trattati b'Intrinsa u 29.4% ta' dawk trattati bil-plaċebo (n=269) irrispondew rigward l-attività sesswali li tissodisfa (riżultat aħħari primarju), meta min irrisponda kien definit minn qabel bħala li kellha żieda fuq medda ta' 4-ġimgħat fil-frekwenza ta' attivitajiet li jissodisfaw ta' > 1.
English: Intrinsa is a transdermal therapy for HSDD, which improves sexual desire while achieving testosterone concentrations compatible with premenopausal levels.
Maltese: Intrinsa hu terapija transdermali għal HSDD, li ttejjeb ix-xewqa sesswali filwaqt li tilħaq konċentrazzjonijiet tat-testosterone li huma kompatibbli ma' livelli ta' qabel il-menopawsa.
English: The efficacy of Intrinsa is reduced if your estrogen therapy is of a certain type (‘conjugated equine estrogens').
Maltese: L-effikaċja ta' Intrinsa titnaqqas jekk it-terapija tiegħek bl-estroġenu tkun ta' ċertu tip (‘conjugated equine estrogens').
English: - anxiety - disturbance in attention - dysgeusia (distorted sense of taste) - impaired balance - hyperaesthesia (abnormal increase in sensitivity to stimuli of the senses) - oral paraesthesia (tingling or numb sensation in the mouth) - transient ischemic attack (mini stroke) - diplopia (double vision) - eye redness - palpitations (rapid and irregular heart beat) - nasal congestion - throat tightness - diarrhoea - dry mouth - nausea - eczema - increased sweating - rosacea (redness of the face) - arthritis - breast cyst - clitoral engorgement - genital pruritus (genital itching sensation) - vaginal burning sensation - anasarca (widespread swelling of the skin) - asthenia (lack of energy and strength) - chest tightness - chest discomfort - abnormal blood fibrinogen (abnormal blood clotting) - increased heart rate - increased alanine aminotransferase, increased aspartate aminotransferase, increased blood bilirubin, abnormal liver function test, increased blood triglycerides (all measures of liver
Maltese: Tużax Intrinsa - jekk inti allerġiku/a (tbati minn sensittività eċċessiva) għat-testosterone jew sustanzi oħra ta' Intrinsa (ara s-sezzjoni ‘Aktar tagħrif' fl-aħħar ta' dan il-fuljett). - jekk taf li kellek fil-passat, jekk għandek, jew jekk taħseb li jista' jkollok, kanċer tas-sider jew kwalunkwe kanċer ieħor li t-tabib tiegħek iddeskriva li kien ikkawżat jew stimulat mill-ormon femminili, l-estroġenu, imsejħin ukoll kanċers ‘dipendenti fuq l-estroġenu'. - jekk inti għandek kundizzjonijiet oħrajn li t-tabib tiegħek jista' jikkunsidra li mhumiex adattati għall-użu ta' l-estroġenu u/jew tat-testosterone.
English: In the combined study analysis at 24 weeks, the difference in the mean frequency of total satisfying episodes between Intrinsa and placebo was 1.07 per 4 weeks.
Maltese: Fl-analiżi ta' l-istudju kombinat wara 24 ġimgħa, id-differenza fil-medja tal-frekwenza ta' episodji totali li jissodisfa bejn Intrinsa u l-plaċebo kienet ta' 1.07 kull 4 ġimgħat.
English: The adverse reaction most often reported (30.4 %) was application site reactions.
Maltese: Sommarju tal-profil tas-sigurtà Ir-reazzjoni avversa li kienet l-aktar irrappurtata (30.4%) kienet reazzjonijiet fis-sit ta' l-applikazzjoni.
English: Breast pain Breast cyst, clitoral engorgement, enlarged clitoris, genital pruritus, vaginal burning sensation
Maltese: Uġigħ fis-sider Ċesti fis-sider, nefħa fil-klitoris, tkabbir tal-klitoris, ħakk ġenitali, sensazzjoni ta' ħruq filvaġina
English: Paediatric population There is no relevant use of Intrinsa in the paediatric population.
Maltese: M'hemmx użu rilevanti għall-użu ta' Intrinsa fil-popolazzjoni pedjatrika.
English: There were no significant differences in serum estradiol and estrone levels in patients treated with Intrinsa for up to 52 weeks compared to baseline.
Maltese: Ma kien hemm l-ebda differenzi sinifikanti fl-estradiol tas-serum u fil-livelli ta' estrone f'pazjenti trattati b'Intrinsa sa 52 ġimgħa meta mqabbla mal-linja bażi.
English: HOW TO STORE INTRINSA
Maltese: X'fih Intrinsa
English: DHT concentrations increased in parallel with testosterone concentrations during Intrinsa treatment.
Maltese: Il-konċentrazzjonijiet tad-DHT żdiedu b'mod parallel mal-konċentrazzjonijiet ta' testosterone matul it-trattament b'Intrinsa.
English: What Intrinsa contains
Maltese: QABEL MA TUŻA INTRINSA
English: Testosterone is mainly excreted in the urine as glucuronic and sulphuric acid conjugates of testosterone and its metabolites.
Maltese: Testosterone jitneħħa primarjament fl-awrina bħala konjugati tal-glucuronic u sulphuric acid tattestosterone u l-metaboliti tiegħu.
English: During 6-month double blind exposure the following adverse reactions occurred in the treatment group (n=549) at a greater incidence than placebo (n=545) and were assessed by the investigators as possibly or probably related to Intrinsa treatment.
Maltese: Matul l-espożizzjoni double blind għal 6 xhur, ir-reazzjonijiet avversi li ġejjin seħħew fil-grupp tattrattament (n=549) f'inċidenza akbar milli fil-grupp tal-plaċebo (n=545) u kienu evalwati mill investigaturi bħala possibbilment jew probabbilment relatati mat-trattament ta' Intrinsa.
English: Intrinsa is indicated for the treatment of hypoactive sexual desire disorder (HSDD) in bilaterally oophorectomised and hysterectomised (surgically induced menopause) women receiving concomitant estrogen therapy.
Maltese: Intrinsa hu indikat għat-trattament ta' mard li fih persuna jkollha nuqqas ta' xewqa sesswali (hypoactive sexual desire disorder, HSDD) f'nisa li kellhom ooforektomija u isterektomija b'mod bilaterali (menopawsa ikkaġunata b'mod kirurġiku) li kienu qed jirċievu terapija bl-estroġenu fl-istess ħin.
English: Intrinsa is designed to systemically deliver 300 micrograms/day.
Maltese: Intrinsa hu maħsub biex iforni b'mod sistemiku, 300 mikrogramma kuljum.
English: Manufacturer
Maltese: Emigranja
English: The safety of Intrinsa has not been evaluated in double blind placebo controlled studies of longer than 1 year duration.
Maltese: Is-sigurtà ta' Intrinsa ma kinitx evalwata fi studji double blind ikkontrollati bil-plaċebo li damu iktar minn sena.
English: Two multi-centre, double-blind, placebo-controlled six month studies in 562 (INTIMATE SM1) and 533 (INTIMATE SM2) oophorectomised and hysterectomised women (surgically induced menopause), aged 20 to 70 years, with HSDD on concomitant estrogen were used to evaluate the efficacy and safety of Intrinsa.
Maltese: (menopawsa ikkaġunata b'mod kirurġiku), li kellhom minn 20 sa 70 sena, bl-HSDD u bl-użu fl-istess ħin ta' l-estroġenu, intużaw biex tiġi evalwata l-effikaċja u s-sigurtà ta' Intrinsa.
English: Testosterone from Intrinsa is transported across intact skin by a passive diffusion process that is primarily controlled by permeation across the stratum corneum.
Maltese: Testosterone minn Intrinsa, jiġi ttrasportat minn ġol-ġilda intatta permezz ta' proċess passiv tad diffużjoni, li huwa primarjament ikkontrollat mix-xterid minn naħa għal oħra ta' l-istratum corneum.
English: It is not known whether Intrinsa increases the risk of breast cancer and endometrium cancer.
Maltese: Mhux magħruf jekk Intrinsa jżidx ir-riskju ta' kanċer tas-sider u kanċer tal-endometriju.
English: There is no information on the safety of Intrinsa beyond 12 months.
Maltese: M'hemm l-ebda informazzjoni dwar is sigurtà ta' Intrinsa wara iktar minn 12-il xahar.
English: Intrinsa is intended for use by women up to the age of 60 years who have had both their ovaries and their womb removed.
Maltese: Intrinsa hu intenzjonat għall-użu minn nisa li għandhom sa 60 sena li kellhom iż-żewġ ovarji u l-utru tagħhom imneħħija.
English: Hirsutism Acne, alopecia Eczema, increased sweating, rosacea
Maltese: Akne, alopeċja Ekżema, żieda fl-għaraq,
English: Nasal congestion, throat tightness
Maltese: Jekk tinsa tibdel il-garża tiegħek
English: Intrinsa 300 micrograms/24 hours transdermal patch Testosterone
Maltese: Intrinsa 300 mikrogramma/24 siegħa garża li tipprovdi mediċina li tgħaddi minn ġol-ġilda
English: Application site reaction (erythema, itching)
Maltese: Testosterone totali (ng/dl)
English: Protective release liner
Maltese: Disturbi fl-għajnejn
English: Intrinsa should not be used in naturally menopausal women Efficacy and safety of Intrinsa in naturally menopausal women with HSDD on concomitant estrogen, with or without progestogen, have not been evaluated.
Maltese: L-effikaċja u s-sigurtà ta' Intrinsa f'nisa li jkollhom menopawsa naturali, bl-HSDD u qed jużaw l estroġenu fl-istess ħin, bi jew mingħajr progestogen, ma kienux evalwati.
English: Serum concentrations of testosterone and SHBG in patients receiving Intrinsa in clinical safety and
Maltese: Il-konċentrazzjonijiet fis-serum tat-testosterone u SHBG f'pazjenti li kienu qed jirċievu Intrinsa fi studji kliniċi dwar is-sigurtà u l-effikaċja
English: The albumin-bound fraction and the unbound fraction are collectively termed ‘bioavailable' testosterone.
Maltese: Il-porzjon li jeħel ma' l-albumina u l-porzjon mhux imwaħħal huma msejħa b'mod kollettiv bħala testosterone ‘bijodisponibbli'.
English: NAME OF THE MEDICINAL PRODUCT Intrinsa 300 micrograms/24 hours transdermal patch
Maltese: INFORMAZZJONI GĦAL MIN QED JAGĦMEL UŻU MINNU Intrinsa 300 mikrogramma/24 siegħa garża li tipprovdi mediċina li tgħaddi minn ġol-ġilda
English: Oedema may be a serious complication from high doses of testosterone, however, this is not expected from low dose of testosterone delivered by the Intrinsa patch.
Maltese: Madankollu, dan mhuwiex mistenni minħabba doża baxxa ta' testosterone fornuta mill-garża ta' Intrinsa.
English: Siliconised polyester film
Maltese: Konġestjoni nażali, dwejjaq filgerżuma
English: Oral use blister OPA/alu/PVC/alu 7 tablets
Maltese: Pilloli miksija b'rita Użu orali folja OPA/alu/PVC/alu
English: Strength Pharmaceutical Form
Maltese: 7 pilloli
English: The full EPAR for Lutathera 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: The summary of the opinion of the Committee for Orphan Medicinal Products for Lutathera can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Maltese: Is-sommarju tal-opinjoni tal-Kumitat għall-Prodotti Mediċinali Orfni għal Lutathera jinstab fis-sit elettroniku tal-Aġenzija: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: Lutathera is a cancer medicine for treating tumours in the gut known as gastroenteropancreatic neuroendocrine tumours (GEP-NETs).
Maltese: Lutathera hija mediċina tal-kanċer għall-kura tat-tumuri fil-musrana magħrufin bħala tumuri newroendokrinali gastroenteropankreatiċi (GEP-NETs, gastroenteropancreatic neuroendocrine tumours).
English: This is a summary of the European public assessment report (EPAR) for Lutathera.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta᾽ valutazzjoni (EPAR) għal Lutathera.
English: Other common side effects affecting more than 1 in 10 patients are thrombocytopenia (low platelet counts), lymphopenia (low levels of lymphocytes, a type of white blood cell), anaemia (low red cell counts), pancytopenia (low levels of all types of blood cells), tiredness and reduced appetite.
Maltese: Effetti sekondarji komuni oħra li jaffettwaw aktar minn pazjent 1 minn kull 10 pazjenti huma tromboċitopenja (l-għadd baxx tal-pjastrini), limfopenija (livelli baxxi ta' limfoċiti, tip ta' ċellola bajda tad-demm), anemija (l-għadd baxx taċ-ċelloli ħomor), panċitopenija (livelli baxxi tat-tipi kollha taċċelloli tad-demm), għeja u nuqqas ta' aptit.
English: What are the risks associated with Lutathera?
Maltese: X' inhuma r-riskji assoċjati ma' Lutathera?
English: Why is Lutathera approved?
Maltese: Għaliex ġie approvat Lutathera?
English: Because the number of patients with GEP-NETs is low, they are considered ‘rare', and Lutathera was designated an ‘orphan medicine' (a medicine used in rare diseases) on 31 January 2008.
Maltese: Peress li n-numru ta' pazjenti li jbatu minn GEP-NETs huwa baxx, dawn huma kkunsidrati ‘rari', u Lutathera ġie kklassifikat bħala ‘mediċina orfni' (mediċina li tintuża f'mard rari) fil-31 ta' Jannar 2008.
English: In a main study of 229 patients with GEP-NETs that contained somatostatin receptors, patients given Lutathera lived for an average of 28 months without their disease getting worse.
Maltese: Fi studju ewlieni ta' 229 pazjent b'GEP-NETs li kien fihom riċetturi ta' somatostatina, il-pazjenti li ngħataw Lutathera għexu għal medja ta' 28 xahar mingħajr ma aggravat il-marda tagħhom.
English: It must also not be given to patients with severely reduced kidney function.
Maltese: Dan m'għandux jingħata lanqas lil pazjenti b'funzjoni tal-kliewi mnaqqsa severament.
English: Other information about Lutathera
Maltese: Kif jintuża Lutathera?
English: Lutathera is given by infusion (drip) into a vein.
Maltese: Lutathera jingħata bħala infużjoni (dripp) ġo vina.
English: Only a minority of patients with GEP-NETs can be cured with surgery and at the time of diagnosis the tumours would have spread in most patients.
Maltese: Minoranza ta' pazjenti b'GEP-NETs biss jistgħu jiġu kkurati b'kirurġija u f'ħafna mill-pazjenti, meta jiġu dijanjostikati, it-tumuri jkunu nfirxu.
English: The active substance in Lutathera, lutetium (177Lu) oxodotreotide, works by attaching to somatostatin receptors, which are found in high numbers in some GEP-NETs.
Maltese: Lu) oxodotreotide, taħdem billi teħel mar-riċetturi ta' somatostatina, li jinsabu f'numri għoljin f'xi GEP-NETs.
English: Lutathera contains the active substance lutetium (177Lu) oxodotreotide.
Maltese: Dan huwa radjufarmaċewtiku (mediċina li temetti ammont żgħir ta' radjuattività).
English: What measures are being taken to ensure the safe and effective use of Lutathera?
Maltese: X'miżuri qegħdin jittieħdu biex jiġi żgurat l-użu sigur u effettiv ta' Lutathera?
English: The company that markets Lutathera will put in place an educational programme for patients to ensure they understand the risk of radioactivity and precautions they should take to limit exposure to themselves and people around them.
Maltese: Il-kumpanija li tqiegħed Lutathera fis-suq se tpoġġi fis-seħħ programm edukattiv għall-pazjenti biex tiżgura li dawn jifhmu r-riskju tar-radjuattività u l-prekawzjonijiet li għandhom jieħdu biex jillimitaw lesponiment għalihom infushom u għan-nies ta' madwarhom.
English: The usual treatment involves 4 infusions 8 weeks apart, but the gap between infusions can be increased to up to 16 weeks if the patient gets severe side effects.
Maltese: Il-kura tas-soltu tinvolvi 4 infużjonijiet 8 ġimgħat bogħod minn xulxin, iżda l-perjodu bejn l-infużjonijiet jista' jiżdied sa 16-il ġimgħa jekk il-pazjent ikollu effetti sekondarji severi.
English: How does Lutathera work?
Maltese: Kif jaħdem Lutathera?
English: 20 December 2010
Maltese: 20 ta' Diċembru 2010
English: Ethirfin is a medicine that contains the active substance morphine sulphate.
Maltese: Ethirfin huwa mediċina li fiha s-sustanza attiva morphine sulphate.
English: EMA/468843/2010 rev. EMEA/H/A-29/001248
Maltese: EMEA/H/A-29/001248
English: What is Ethirfin?
Maltese: X'inhu Ethirfin?
English: The company applied for the marketing authorisation to be renewed in Denmark (the ‘reference Member State').
Maltese: Il-kumpanija applikat għallawtorizzazzjoni għat-tqegħid fis-suq li għandha tiġġedded mid-Danimarka (l-‘Istat Membru ta' referenza').
English: This renewal was to be recognised in Germany, Ireland, Italy and the United Kingdom (the ‘concerned Member States').
Maltese: Dan it-tiġdid kellu jiġi rikonoxxut fil-Ġermanja, fl-Irlanda, fl-Italja u fir-Renju Unit (l-‘Istat Membru kkonċernat').
English: Why was Ethirfin reviewed?
Maltese: Għaliex ġie rivedut Ethirfin?
English: The grounds for the referral were concerns that the active substance in the capsules could be released too quickly if the capsules are taken with alcohol, because they contain a ‘polymethacrylatetriethylcitrate' coating to control the release of morphine and this coating is soluble in alcohol.
Maltese: Ir-raġunijiet għar-referenza kienu tħassib li s-sustanza attiva fil-kapsuli tista' tiġi rilaxxata malajr wisq jekk il-kapsuli jittieħdu mal-alkoħol, minħabba li dawn fihom kisja ta' ‘polymethacrylate-triethylcitrate' sabiex tikkontrolla r-rilaxx tal-morfina u din il-kisja ddub fl-alkoħol.
English: Ethirfin was authorised in the European Union (EU) under a mutual recognition procedure on the basis of the initial authorisation granted by Denmark on 15 July 2005.
Maltese: Ethirfin ġie awtorizzat fl-Unjoni Ewropea (UE) skont proċedura ta' rikonoxximent reċiproku fuq il-bażi tal-awtorizzazzjoni inizjali mogħtija mid-Danimarka fil-15 ta' Lulju 2005.
English: The rapid release of the active substance is called ‘dose dumping' and could put patients at risk of exposure to large doses of morphine, leading to side effects such as respiratory depression (an inhibition of breathing).
Maltese: Ir-rilaxx rapidu tas-sustanza attiva jissejjaħ ‘dumping tad-doża' u jista' jpoġġi lill-pazjenti f'riskju ta' espożizzjoni għal dożi kbar ta' mofrina, u dan iwassal għal effetti sekondarji bħal dipressjoni respiratorja (inibizzjoni tat-teħid tannifs).
English: Because these Member States were not able to reach an agreement, the German and United Kingdom medicines regulatory agencies referred the matter to the CHMP for arbitration on 30 October 2009.
Maltese: Minħabba li dawn l-Istati Membri ma setgħux jaslu għal ftehim, l-aġenziji regolatorji tal-mediċini tal-Ġermanja u tar-Renju Unit, irriferew il-kwistjoni lis-CHMP għal arbitraġġ fit30 ta' Ottubru 2009.
English: The European Medicines Agency has completed an arbitration procedure for Ethirfin and associated names.
Maltese: L-Aġenzija Ewropea tal-Mediċini temmet proċedura ta' arbitraġġ għal Ethirfin u l-ismijiet assoċjati.
English: Questions and answers on Ethirfin and associated names (morphine sulphate, prolonged-release capsules, 20, 60, 120 and 200 mg) EMA/297829/2011
Maltese: Il-Kummissjoni Ewropea ħarġet deċiżjoni fuq din l-opinjoni fl-20 ta' Diċembru 2010.
English: Based on evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that there is a significant interaction between Ethirfin and alcohol, and that patients taking Ethirfin and alcohol are at risk of developing serious side effects.
Maltese: Fuq il-bażi tal-evalwazzjoni tad-dejta disponibbli attwalment u tad-diskussjoni xjentifika fi ħdan ilKumitat, is-CHMP ikkonkluda li hemm interazzjoni sinifikanti bejn Ethirfin u l-alkoħol, u li pazjenti li jkunu qegħdin jieħdu Ethirfin u l-alkoħol jinsabu f'riskju li jiżviluppaw effetti sekondarji serji.
English: Package size
Maltese: 10 ml
English: EMA/355543/2016 EMEA/H/C/000494
Maltese: EMA/355543/2016 EMA/H/C/000494
English: Reyataz atazanavir
Maltese: Reyataz atażanavir