FrancophonIA/ELRC3.0 huggingface dataset:
English: In cooperation with King's College London, the Agency initiated a study on its benefit-risk communication activities, aimed at describing the Agency's approach to benefit-risk communication and identifying proposals for future implementation.
Maltese: F'kooperazzjoni ma' King's College London, l-Aġenzija bdiet studju dwar l-attivitajiet ta' komunikazzjoni ta' benefiċċju-riskju tagħha, immirati lejn id-deskrizzjoni tal-approċċ tal-Aġenzija għall-komunikazzjoni ta' benefiċċji-riskji u għall-identifikazzjoni ta' proposti għal implimentazzjoni futura.
English: While the rate of submission of applications for veterinary medicines was reasonably steady, there was a considerable increase in the number of requests relating to veterinary scientific advice and pharmacovigilance activities.
Maltese: Filwaqt li r-rata ta' sottomissjoni ta' applikazzjonijiet għal mediċini veterinarji kienet waħda raġonevolment fissa, kien hemm żieda konsiderevoli fit-talbiet relatati mal-parir xjentifiku veterinarju u ma' attivitajiet ta' farmakoviġilanza.
English: The mobilisation of scientific experts from all over the EU made it possible to fast-track the scientific review of vaccines, so that by October 2009 three centrally authorised pandemic H1N1 vaccines were available for use by public-health authorities in the EU Member States.
Maltese: Il-mobilizzazzjoni ta' esperti xjentifiċi minn madwar l-UE kollha għamlitha possibbli li titħaffef ir-reviżjoni xjentifika tal-vaċċini, sabiex sa Ottubru 2009, kien hemm disponibbli tliet vaċċini H1N1 pandemiċi awtorizzati ċentralment għall-użu mill-awtoritajiet tas-saħħa pubblika fl-Istati Membri tal-UE.
English: The Agency unveiled its new visual identity on 8 December 2009.
Maltese: L-Aġenzija kixfet l-identità viżiva ġdida tagħha fit-8 ta' Diċembru 2009.
English: Public consultation on draft EudraVigilance access policies in relation to human and veterinary medicines was completed in the spring of 2009, and work on revising the draft policies began.
Maltese: Konsultazzjoni pubblika dwar abbozz ta' politiki ta' aċċess tal-EudraViġilanza fir-rigward ta' mediċini umani u veterinarji ntemmet fir-rebbiegħa tal-2009, u beda x-xogħol dwar ir-reviżjoni tal-abbozz talpolitiki.
English: The Agency developed a European strategy for benefit/risk monitoring of A/H1N1 influenza vaccines, in close collaboration with the European Centre for Disease Prevention and Control (ECDC) and the HMA.
Maltese: L-Aġenzija żviluppat strateġija Ewropea għall-monitoraġġ tal-benefiċċju/riskju ta' vaċċini tal-influwenza tal-A/H1N1, f'kollaborazzjoni mill-qrib maċ-Ċentru Ewropew għall-Prevenzjoni u l-Kontroll tal-Mard (ECDC) u l-HMA.
English: The CAT is a multidisciplinary committee made up of some of the best experts in the field.
Maltese: Is-CAT huwa kumitat multidixxiplinarju magħmul minn xi wħud mill-aqwa esperti fil-qasam.
English: An action plan on paediatric pharmacovigilance, based on EudraVigilance data, was adopted in May 2009 to further strengthen the intensive monitoring of paediatric use of medicines.
Maltese: F'Mejju 2009, ġie adottat pjan ta' azzjoni dwar farmakoġilanza pedjatrika, ibbażat fuq dejta ta' EudraViġilanza, sabiex isaħħaħ aktar il-monitoraġġ intensiv ta' użu pedjatriku tal-mediċini.
English: Topics covered in 2009 included biomarkers and other novel development methods, nanotechnologies in life sciences and reinforced coordination between pharmaceuticals and devices authorities for the evaluation of targeted and combined medicinal products.
Maltese: Is-suġġetti koperti fl-2009 inkludew bijomarkaturi u metodi ta' żvilupp ġodda oħrajn, nanoteknoloġiji fi xjenzi talħajja u koordinazzjoni rinfurzata bejn l-awtoritajiet tal-farmaċewtiċi u tal-apparat għall-evalwazzjoni ta' prodotti mediċinali fil-mira u kkombinati.
English: Bilateral relations with the US Food and Drug Administration (FDA) and the Japanese authorities were greatly enhanced when the notion of liaison placements was agreed.
Maltese: Ir-relazzjonijiet bilaterali mal-Amministrazzjoni tal-US dwar l-Ikel u l-Mediċini (FDA) u mal-awtoritajiet Ġappuniżi tjiebu b'mod sostanzjali meta ntlaħaq qbil fuq in-nozzjoni ta' ippustjar ta' impjegati ta' kollegament.
English: A pilot phase of the EU regulatory system incident-management plan for medicines for human use was launched on 1 June 2009.
Maltese: Fażi pilota tal-pjan ta' ġestjoni ta' inċidenti tas-sistema regolatorja tal-UE għal mediċini għall-użu millbniedem tnediet fl-1 ta' Ġunju 2009.
English: The Agency was immediately engaged in monitoring the situation following the initial outbreak, in April, and subsequently stepped up its activities as the WHO raised the pandemic level.
Maltese: L-Aġenzija tqabbdet minnufih fil-monitoraġġ tas-sitwazzjoni wara t-tifqigħa inizjali, f'April, u sussegwentament żiedet l-attivitajiet tagħha hekk kif il-WHO żiedet il-livell tal-pandemija.
English: By the end of the year, the international strategy was included as an important part of the Agency's 'Road map to 2015', adopted by the Agency's Management Board for public consultation.
Maltese: Sal-aħħar tas-sena, l-istrateġija internazzjonali ġiet inkluża bħala parti importanti mill-‘Pjan Direzzjonali għall-2015' tal-Aġenzija, adottat mill-Bord ta' Amministrazzjoni tal-Aġenzija għal konsultazzjoni pubblika.
English: Implementing and operating the Advanced Therapies Regulation and other new legislation
Maltese: Implimentazzjoni u tħaddim tar-Regolament dwar Terapiji Avvanzati u leġiżlazzjoni ġdida oħra
English: Office of the Executive Director
Maltese: Uffiċċju tad-Direttur Eżekuttiv
English: The outbreak of the 2009 H1N1 influenza pandemic put significant pressure on the European Medicines Agency and the European medicines network.
Maltese: It-tifqigħa tal-pandemija tal-influwenza tal-H1N1 tal-2009 poġġiet pressjoni sinifikanti fuq l-Aġenzija Ewropea tal-Mediċini u fuq in-netwerk Ewropew tal-mediċini.
English: The network demonstrated its strength during the 2009 H1N1 influenza pandemic.
Maltese: In-netwerk wera s-saħħa tiegħu matul il-pandemija tal-influwenza tal-H1N1 tal-2009.
English: The Agency's sixth scientific committee, the Committee for Advanced Therapies (CAT), was inaugurated in January 2009, in accordance with provisions contained in the new legislation on advanced therapy medicinal products (ATMPs).
Maltese: Is-sitt kumitat xjentifiku tal-Aġenzija, il-Kumitat għal Terapiji Avvanzati (CAT), ġie inawgurat f'Jannar 2009, skont id-dispożizzjonijiet li hemm fil-leġiżlazzjoni l-ġdida dwar prodotti mediċinali ta' terapija avvanzata (ATMPs).
English: The Committee deals with ATMPs for human use that are based on gene therapy, somatic cell therapy or tissue engineering.
Maltese: Il-kumpaniji maġġuri kollha issa huma reġistrati u qegħdin jużaw rapportar elettroniku permezz tal-EVVet.
English: For one of these medicines, a tissue-engineered product containing chondrocytes, the CAT proposed a positive opinion to the Agency's Committee for Medicinal Products for Human Use (CHMP).
Maltese: Għal waħda minn dawn il-mediċini, prodott ta' inġinerija tat-tessut li fih chondrocytes, is-CAT ippropona opinjoni pożittiva lill-Kumitat għall-Prodotti Mediċinali għal Użu Mill-Bniedem (CHMP) talAġenzija.
English: In August 2009, the Agency signed its latest confidentiality arrangement with the Australian Therapeutic Goods Administration (TGA), bringing the number of confidentiality arrangements in place to four.
Maltese: F'Awwissu 2009, l-Aġenzija ffirmat l-aktar arranġament ta' kunfidenzjalità reċenti tagħha malAmministrazzjoni tal-Oġġetti Terapewtiċi Awstraljana (TGA), li tellgħet in-numru ta' arranġamenti ta' kunfidenzjalità fis-seħħ għal erbgħa.
English: Development of a new public website for the Agency - designed with the needs of the public in mind, offering improved navigation and search functionality, and better access to information on publichealth issues - was also a significant undertaking during the course of 2009.
Maltese: L-iżvilupp ta' websajt pubblika ġdida għall-Aġenzija - imfassla apposta skont il-ħtiġijiet tal-pubbliku, li toffri navigazzjoni u funzjonalità ta' tfittxija mtejba, u aċċess aħjar għall-informazzjoni dwar kwistjonijiet tas-saħħa pubblika - kienet biċċa xogħol sinifikanti matul il-kors tal-2009.
English: When the first reported cases of infection emerged from Mexico, in April, the Agency reacted quickly, working closely with its European and international partners to monitor the situation and develop appropriate measures to deal with the emerging crisis, including meeting with vaccine manufacturers and influenza experts from across the EU to prepare for the development and authorisation of vaccines that could be used to protect people and minimise the spread of the virus.
Maltese: Meta ħarġu l-ewwel każijiet irrapportati mill-Messiku, f'April, l-Aġenzija rreaġġixxiet malajr, u ħadmet mill-qrib mal-imsieħba Ewropej u internazzjonali tagħha sabiex timmonitorja s-sitwazzjoni u tiżviluppa miżuri xierqa sabiex tindirizza l-kriżi emerġenti, inkluż laqgħat mal-manifatturi tal-vaċċin u mal-esperti tal-influwenza minn madwar l-UE sabiex tħejji għall-iżvilupp u għall-awtorizzazzjoni ta' vaċċini li jkunu jistgħu jintużaw sabiex jipproteġu lin-nies u jimminimizzaw il-firxa tal-virus.
English: Updated product information in all EU languages, weekly pharmacovigilance reports and much other scientific and regulatory information was published in a dedicated section of the Agency's website.
Maltese: Ġiet ippubblikata informazzjoni aġġornata dwar il-prodott fil-lingwi kollha tal-UE, kif ukoll rapporti ta' farmakoviġilanza ta' kull ġimgħa u ħafna informazzjoni xjentifika u regolatorja oħra f'sezzjoni ddedikata tal-websajt tal-Aġenzija.
English: Once a pandemic had been officially declared by the World Health Organization and the strain of the virus had been identified, in June, pharmaceutical companies were in a position to begin submitting data on H1N1 vaccines to the Agency.
Maltese: Meta ġiet iddikjarata uffiċjalment pandemija mill-Organizzazzjoni Dinjija tas-Saħħa u r-razza tal-virus ġiet identifikata, f'Ġunju, il-kumpaniji farmaċewtiċi kienu f'pożizzjoni li jibdew jissottomettu dejta dwar il-vaċċini tal-H1N1 lill-Aġenzija.
English: Looking to the future of medicines development, the Agency invites discussion on innovative therapeutic approaches and new development methods for human medicines.
Maltese: Hija u tħares lejn il-futur tal-iżvilupp tal-mediċini, l-Aġenzija tistieden diskussjoni dwar approċċi terapewtiċi innovattivi u metodi ġodda ta' żvilupp għall-mediċini għal użu mill-bniedem.
English: MedDRA System Organ Class (SOC)
Maltese: Sistema talKlassifika talOrgani MedDRA (SOC)
English: − The active substance is degarelix.
Maltese: - Is-sustanza attiva hi degarelix.
English: 2300 Copenhagen S Denmark
Maltese: 2300 Copenhagen S Id-Danimarka
English: DK-2300 Copenhagen S Denmark
Maltese: DK-2300 Copenhagen S Id-Danimarka
English: Powder Mannitol (E421)
Maltese: Trab Mannitol (E421)
English: − Diabetes mellitus.
Maltese: − Dijabete mellitus.
English: Тел: +359 2 807 5022 aquachim@aquachim.bg
Maltese: Те: +359 2 807 5022 aquachim@aquachim.bg
English: − depression, mental impairment
Maltese: − dipressjoni, indeboliment mentali
English: Paediatric population
Maltese: Populazzjoni pedjatrikja
English: The median age was 74 years (range 47 to 98 years).
Maltese: (medda minn 47 sa 98 sena).
English: Table 3: Cumulative probability of testosterone ≤0.5 ng/ml from Day 28 to Day 364.
Maltese: Tabella 3: Probabbiltà kumulattiva ta' testosterone ≤0.5 ng/ml minn Jum 28 sa Jum 364.
English: In vitro studies have shown that degarelix is not a substrate for the human CYP450 system.
Maltese: Studji in vitro wrew li degarelix mhuwiex substrat għas sistema CYP450 umana.
English: FIRMAGON is available in 2 pack-sizes:
Maltese: FIRMAGON hu disponibbli f'2 daqsijiet ta' pakketti:
English: A. Potamitis Medicare Ltd Τηλ: +357 22583333 a.potamitismedicare@cytanet.com.cy
Maltese: Potamitis Medicare Ltd Τηλ: +357 22583333 a.potamitismedicare@cytanet.com.cy
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
English: EU/1/08/504/001 Pack-size of 1 tray EU/1/08/504/003 Pack-size of 3 trays
Maltese: EU/1/08/504/001 Daqs tal-pakkett ta' 1 trej EU/1/08/504/003 Daqs tal-pakkett ta' 3 trejs
English: methadone (used for pain relief and part of drug addiction detoxification), moxifloxacin (an antibiotic), antipsychotics ).
Maltese: detossifikazzjoni mill-vizzju tad-droga), moxifloxacin, mediċini antipsikotiċi).
English: Day 14 Day 28
Maltese: Jum 28
English: Malaise, peripheral oedema
Maltese: Telqa, edema periferali
English: atrial fibrillation), palpitations, QT prolongation*(see sections 4.4 and 4.5)
Maltese: Arritmija kardijaka (li tinkludi fibrillazzjoni atrijali), palpitazzjonijiet, titwil tal-QT* (ara sezzjonijiet 4.4 u 4.5)
English: A very serious allergic reaction to this medicine is rare.
Maltese: Reazzjoni allerġika serja ħafna għal din il-mediċina hi rari.
English: • 20% had metastatic prostate cancer
Maltese: • 20% kellhom kanċer tal-prostata metastatiku
English: This difference was statistically significant (p<0.001).
Maltese: Din id-differenza kienet statistikament sinifikanti (p<0.
English: Bilirubin increased, alkaline phosphatase increased
Maltese: Żieda fil-bilirubina, żieda fl-alkaline phosphatase
English: − Severe hypersensitivity.
Maltese: − Sensittività eċċessiva severa.
English: • 7% had an unknown metastatic status
Maltese: • 7% kellhom stat metastatiku mhux magħruf
English: Mental impairment, hypoaesthesia
Maltese: Indeboliment mentali, ipoestesija
English: Effect on QT/QTc intervals
Maltese: Effett fuq l-intervalli tal-QT/QTc
English: Anti-degarelix antibody
Maltese: Antikorp antidegarelix
English: Degarelix mimics a natural hormone (gonadotrophin-relasing hormone, GnRH) and directly blocks its effects.
Maltese: Degarelix jimita ormon naturali (ormon li jerħi gonadotrophin, GnRH) u direttament jimblokka l-effetti tiegħu.
English: FIRMAGON contains degarelix.
Maltese: FIRMAGON fih degarelix.
English: The powder is white to off-white.
Maltese: It-trab hu minn abjad sa off-white.
English: − anaemia
Maltese: − anemija
English: Cardiovascular disease
Maltese: insuffiċjenza kardijaka
English: Injection needles (25G 0.5 x 25 mm)
Maltese: Labra tal-injezzjoni (25G 0.5 x 25 mm)
English: Inject 4 ml of FIRMAGON 80 mg slowly,
Maltese: Injetta 4 ml ta' FIRMAGON 80 mg bil-mod,
English: Pollakiuria, micturition urgency, dysuria, nocturia, renal impairment, incontinence
Maltese: nokturja, indeboliment renali, inkontinenza
English: <1/1,000) and very rare (<1/10,000).
Maltese: sa <1/1,000) u rari ħafna (<1/10,000).
English: Date of first authorisation: 17/02/2009 Date of latest renewal: 19/09/2013
Maltese: Data tal-ewwel awtorizzazzjoni: 17/02/2009 Data tal-aħħar tiġdid: 19/09/2013
English: The efficacy and safety of degarelix was evaluated in an open-label, multi-centre, randomised, active comparator controlled, parallel-group study.
Maltese: L-effikaċja u s-sigurtà ta' degarelix kienu evalwati fi studju open-label, multiċentriku, randomised, ikkontrollat minn komparatur attiv, u f'grupp parallel.
English: Testosterone Reversibility
Maltese: Riversibbiltà tat-Testosterone
English: Injection needle (25G 0.5 x 25 mm)
Maltese: Labriet għall-injezzjoni (25G 0.5 x 25 mm)
English: Attainment of serum testosterone (T) ≤0.5 ng/ml FIRMAGON is effective in achieving fast testosterone suppression, see Table 2.
Maltese: Il-kisba ta' testosterone fis-serum ta' ≤0.5 ng/ml FIRMAGON hu effettiv fil-kisba ta' trażżin mgħaġġel tat-testosterone, ara Tabella 2.
English: How to use FIRMAGON
Maltese: Tużax FIRMAGON
English: Inject 3 ml of FIRMAGON 120 mg slowly,
Maltese: Injetta 3 ml ta' FIRMAGON 120 mg bil-mod,
English: Median testosterone levels after one year of treatment were 0.087 ng/ml (interquartile range 0.06-0.15) N=167.
Maltese: Il-medjan tal-livelli tat-testosterone wara sena ta' kura kien ta' 0.087 ng/ml (medda interquartile minn 0.06-0.15) N=167.
English: EU/1/08/504/001
Maltese: EU/1/08/504/001 EU/1/08/504/003
English: Following subcutaneous administration of 240 mg degarelix at a concentration of 40 mg/ml to prostate cancer patients in the pivotal study CS21, AUC0-28 days was 635 (602-668) day*ng/ml, Cmax was 66.0 (61.071.0) ng/ml and occurred at tmax at 40 (37-42) hours.
Maltese: Wara l-għoti taħt il-ġilda ta' 240 mg ta' degarelix f'konċentrazzjoni ta' 40 mg/ml lil pazjenti b'kanċer tal prostata fl-istudju importanti ħafna CS21, l-AUC0-28 jum kienet ta' 635 (602-668) kuljum*ng/ml, is-Cmax kienet ta' 66.0 (61.0-71.0) ng/ml u seħħet f'tmax f'40 (37-42) siegħa.
English: • 31% had localised prostate cancer
Maltese: • 31% kellhom kanċer tal-prostata lokalizzat
English: Gynaecomastia*, testicular atrophy*, erectile dysfunction*
Maltese: Ġinekomastija*, atrofija testikulari*, disfunzjoni erettili*
English: Long term treatment with the maintenance dose up to 1 year shows that 97% of the patients have sustained suppressed testosterone levels (T≤0.5 ng/ml).
Maltese: Il-kura fit-tul bid-doża tal-manteniment sa sena turi li 97% tal-pazjenti jkollhom livelli ta' testosterone imrażżna sostnuti (T≤0.5 ng/ml).
English: Tel: +386 1 5899 179 regulatory@salus.si
Maltese: SALUS, Veletrgovina, d.o.o. Tel: +386 1 5899 179 regulatory@salus.si
English: FIRMAGON is available in 2 pack-sizes.
Maltese: FIRMAGON hu disponibbli f'2 daqsijiet tal-pakkett.
English: 8 cases of rhabdomyolysis have cumulativly been reported with degarelix.
Maltese: 8 każijiet ta' rhabdomyolysis ġew irrapportati b'mod kumulattiv b'degarelix.
English: 2 vial adapters
Maltese: 2 adapters tal-kunjett
English: Tabulated list of adverse reactions The frequency of undesirable effects listed below is defined using the following convention:
Maltese: Il-frekwenza tal-effetti mhux mixtieqa elenkati hawn taħt hi definita bl-użu tal-konvenzjoni li ġejja:
English: 3 vial adapter
Maltese: 3 adapters tal-kunjett
English: Markedly abnormal values of potassium (≥5.8 mmol/l), creatinine (≥177 μmol/l) and BUN (≥10.7 mmol/l) in patients with normal values prior to treatment, were seen in 6%, 2% and 15% of degarelix treated patients and 3%, 2% and 14% of leuprorelin treated patients, respectively.
Maltese: u BUN (≥10.7 mmol/l) f'pazjenti b'valuri normali qabel il-kura, kienu osservati f'6%, 2% u 15% tal-pazjenti kkurati b'degarelix, u fi 3%, 2% u 14% tal-pazjenti kkurati b'leuprorelin, rispettivament.
English: Perform a deep subcutaneous injection.
Maltese: Wettaq injezzjoni profonda taħt il-ġilda.
English: Day 7 Day 14 Day 28
Maltese: Jum 1 Jum 3 Jum 7 Jum 14
English: Mannitol (E421), water for injections
Maltese: TA' EĊĊIPJENTI Mannitol (E421), ilma għall-injezzjonijiet
English: Degarelix is not a substrate for the human CYP450 system and has not been shown to induce or inhibit CYP1A2, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1, or CYP3A4/5 to any great extent in vitro.
Maltese: CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1, jew CYP3A4/5 f'xi grad partikularment kbir in vitro.
English: Tel/Tél: +32 53 72 92 00 ferringnvsa@ferring.be
Maltese: +32 53 72 92 00 ferringnvsa@ferring.be
English: Mean trough values were approximately 11-12 ng/ml after the starting dose and 11-16 ng/ml after maintenance dosing of 80 mg at a concentration of 20 mg/ml.
Maltese: Il-medja tal-valuri minimi kienu ta' madwar 11-12 ng/ml wara d-doża tal-bidu, u 11-16 ng/ml wara d-doża tal-manteniment ta' 80 mg f'konċentrazzjoni ta' 20 mg/ml.
English: The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Maltese: • Rapporti Perjodiċi Aġġornati dwar is-Sigurtà Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq għandu jippreżenta rapporti perjodiċi aġġornati dwar is sigurtà għal dan il-prodott f'konformità mar-rekwiżiti mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u ppubblikati fuq il-portal elettroniku Ewropew tal-mediċini.
English: There is no clinical experience with the effects of an acute overdose with degarelix.
Maltese: M'hemm l-ebda esperjenza klinika bl-effetti ta' doża eċċessiva akuta b'degarelix.
English: • Information on the identified and potential risks
Maltese: • Informazzjoni dwar ir-riskji identifikati u potenzjali
English: − reduced size of testicles, breast swelling, impotence
Maltese: − tnaqqis fid-daqs tat- testikoli, nefħa fis-sider, impotenza
English: Busuttil Ltd. Tel: +356 21447184 info@ejbusuttil.com
Maltese: Tel: +356 21447184 info@ejbusuttil.com
English: Fertility FIRMAGON may inhibit male fertility as long as the testosterone is suppressed.
Maltese: Fertilità FIRMAGON jista' jimpedixxi l-fertilità maskili sakemm it-testosterone jiġi mrażżan.
English: office@ferring.at
Maltese: info@ferring.fi
English: • 29% had locally advanced prostate cancer
Maltese: • 29% kellhom kanċer tal-prostata lokalment avvanzat
English: 1 vial adapter
Maltese: 1 adapter tal-kunjett
English: Liver transamina ses increased
Maltese: Żieda fit transaminases talfwied
English: Figure 1: Percentage change in testosterone from baseline by treatment group until day 28 (median with interquartile ranges).
Maltese: Figura 1: Bidla perċentwali fit-testosterone mil-linja bażi skont il-grupp tal-kura sa jum 28 (medjan bilmeded interquartile).
English: Pack-size of 3 trays containing: 3 powder vials, 3 solvent pre-filled syringes, 3 plunger rods, 3 vial adapters and 3 needles.
Maltese: Daqs ta' pakkett ta' 3 trej li jkun fih: 3 kunjetti bit-trab, 3 siringi mimlija għal-lest bis-solvent, 3 lasti talplanġer, 3 adapters tal-kunjett u 3 labriet.
English: This medicine is usually injected by a nurse or a doctor.
Maltese: Din il-mediċina normalment tiġi injettata minn infermier jew tabib.
English: In the degarelix 240/80 mg treatment group 41 (20%) patients discontinued the study, as compared to 32 (16%) patients in the leuprorelin group.
Maltese: Fil-grupp tal-kura ta' degarelix 240/80 mg, 41 (20%) pazjent ma komplewx bl-istudju, meta mqabbel ma' 32 (16%) pazjent fil-grupp ta' leuprorelin.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/.
Maltese: Informazzjoni dettaljata dwar din il-mediċina mediċinali tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini: http://www.ema.europa.eu/.
English: How to store FIRMAGON Contents of the pack and other information
Maltese: Kontenut tal-pakkett u informazzjoni oħra
English: Cardiovascular disease such as stroke and myocardial infarction has been reported in the medical literature in patients with androgen deprivation therapy.
Maltese: Mard kardjovaskulari bħal puplesija u infart mijokardijaku ġew irrappurtati fil-letteratura medika f'pazjent b'terapija ta' deprivazzjoni ta' androgen.
English: Myocardial infarction, cardiac failure
Maltese: Infart mijokardijaku,
English: Pack-size of 3 trays containing:
Maltese: Pakkett bi 3 ikun fih:
English: FIRMAGON is a gonadotrophin releasing hormone (GnRH) antagonist indicated for treatment of adult male patients with advanced hormone-dependent prostate cancer.
Maltese: FIRMAGON hu antagonist tal-ormon li jerħi gonadotrophin (GnRH) indikat għall-kura ta' pazjenti rġiel adulti b'kanċer tal-prostata avvanzat dipendenti fuq l-ormoni.