FrancophonIA/ELRC3.0 huggingface dataset:
English: Arixtra is used to treat adults with a blood clot in the blood vessels of their legs (deep vein thrombosis) and/or lungs (pulmonary embolism).
Maltese: Arixtra tintuża bħala trattament f'adulti li għandhom għoqda tad-demm fil-vini u arterji ta‘ riġlejhom (trombożi f'vina fonda) u/jew fil-pulmun (emboliżmu pulmonari).
English: Each pre-filled syringe (0.5 ml) contains 2.5 mg of fondaparinux sodium.
Maltese: Siringa waħda mimlija lesta (0.5 ml) fiha 2.5 mg fondaparinux sodium.
English: Initiation of appropriate therapy such as surgical haemostasis, blood replacements, fresh plasma transfusion, plasmapheresis should be considered.
Maltese: Għandha tiġi kkunsidrata li tinbeda terapija xierqa bħal emostażi kirurġika, sostituzzjoni tad-demm, trasfużjoni mill-ġdid ta' plażma, plażmafereżi.
English: • Treatment of UA/NSTEMI and STEMI - Fondaparinux should not be used in patients with creatinine clearance < 20 ml/min (see section 4.3).
Maltese: • Trattament ta' UA/NSTEMI u STEMI - Fondaparinux m'għandux jingħata lil pazjenti bi clearance tal-krejatinina < 20 ml/min (ara sezzjoni 4.3).
English: The dose should be reduced to 1.5 mg once daily in patients with creatinine clearance in the range of 20 to 50 ml/min (see sections 4.2 and 5.2).
Maltese: Id-doża għandha titnaqqas għal 1.5 mg darba kuljum f'pazjenti bi tneħħija tal-krejatinina fuq medda bejn 20 u 50 ml/min (ara sezzjonijiet 4.2 u 5.2).
English: Fondaparinux should be used with caution in elderly patients (see section 4.2).
Maltese: Fondaparinux għandu jintuża b'attenzjoni f' pazjenti anzjani (ara sezzjoni 4.2).
English: Arixtra 5 mg/0.4 ml solution for injection, pre-filled syringe.
Maltese: Arixtra 5 mg/0.4 ml soluzzjoni għall-injezzjoni, siringa mimlija lesta
English: EU/1/02/206/005-008 EU/1/02/206/024 EU/1/02/206/025 EU/1/02/206/026
Maltese: EU/1/02/206/005-008 EU/1/02/206/024
English: Experience shows that in patients undergoing hip fracture surgery, the risk of VTE continues beyond 9 days after surgery.
Maltese: evalwata sa jum 11 wara l-kirurġija, irrispettivament mit-tip ta' kirurġija li tkun saret.
English: The needle shield of the pre-filled syringe may contain dry natural latex rubber that has the potential to cause allergic reactions in latex sensitive individuals.
Maltese: L-għatu ta' protezzjoni tal-labra tas-siringa mimlija għal-lest fih lastiku tallattiċe naturali niexef li għandu l-potenzjal li jikkawża reazzjonijiet allerġiċi f'individwi sensittivi tal lattiċe.
English: Patients with superficial-vein thrombosis
Maltese: Pazjenti bi trombożi fil-vini superfiċjali
English: NAME OF THE MEDICINAL PRODUCT Arixtra 7.5 mg/0.6 ml solution for injection fondaparinux sodium
Maltese: Arixtra 7.5 mg/0.6 ml soluzzjoni għall-injezzjoni fondaparinux Na
English: Following once daily dosing, steady state of plasma levels is obtained after 3 to 4 days with a 1.3-fold increase in Cmax and AUC.
Maltese: Meta tibda tittieħed id- doża darba kuljum, livelli fissi fil-plażma jintlaħqu wara 3 sa 4 t‘ijiem, b'żieda ta' 1.3 darba iżjed f' Cmax u AUC.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Arixtra 2.5 mg/0.5 ml injection fondaparinux Na
Maltese: Arixtra 2.5 mg/0.5 ml soluzzjoni għall-injezzjoni fondaparinux Na
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Arixtra 1.5 mg/0.3 ml injection fondaparinux Na
Maltese: Arixtra 1.5 mg/0.3 ml soluzzjoni għall-injezzjoni fondaparinux Na
English: Rare: hypotension
Maltese: Rari: sturdament
English: EU/1/02/206/024 - 2 pre-filled syringes with a manual safety system EU/1/02/206/025 - 10 pre-filled syringes with a manual safety system EU/1/02/206/026 - 20 pre-filled syringes with a manual safety system
Maltese: EU/1/02/206/024- 2 siringi mimlijin lesti b'sistema manwali ta' sigurtà EU/1/02/206/025 - 10 siringi mimlijin lesti b'sistema manwali ta' sigurtà EU/1/02/206/026 - 20 siringi mimlijin lesti b'sistema manwali ta' sigurtà
English: As a result, the concentration of fondaparinux is expressed as milligrams (mg).
Maltese: Għalhekk, il-konċentrazzjoni ta' fondaparinux tidher bħala milligrammi (mg).
English: The recommended dose of fondaparinux is 7.5 mg (patients with body weight ≥ 50, ≤ 100kg) once daily administered by subcutaneous injection.
Maltese: Id-doża rakkomandata ta' fondaparinux hija ta' 7.5 mg (f' pazjenti b'piż ta' ≥ 50, ≥ 100 kg) darba kuljum li tingħata b'injezzjoni subkutanja.
English: EU/1/02/206/027 - 2 pre-filled syringes with a manual safety system EU/1/02/206/028 - 10 pre-filled syringes with a manual safety system EU/1/02/206/033 - 20 pre-filled syringes with a manual safety system
Maltese: EU/1/02/206/027- 2 siringi mimlijin lesti b'sistema manwali ta' sigurtà EU/1/02/206/028 - 10 siringi mimlijin lesti b'sistema manwali ta' sigurtà EU/1/02/206/033 - 20 siringi mimlijin lesti b'sistema manwali ta' sigurtà
English: • syringe with magenta plunger and a manual safety system.
Maltese: • siringa ta'kulur maġenta u b'sistema manwali ta' sigurtà
English: The safety and efficacy of fondaparinux 2.5 mg has not been studied in the following groups: patients with superficial-vein thrombosis following sclerotherapy or resulting as a complication of an intravenous line, patients with history of superficial-vein thrombosis within the previous 3 months, patients with history of venous thromboembolic disease within the previous 6 months, or patients with active cancer (see section 4.2 and 5.1).
Maltese: Is-sigurtà u l-effikaċja ta' fondaparinux 2.5 mg ma ġietx studjata fil-gruppi li ġejjin: pazjenti bi trombożi fil-vini superfiċjali wara skleroterapija jew li ġejja minn kumplikazzjoni ta' pajp intravenuż, pazjenti bi storja medika ta' trombożi fil-vini superfiċjali fit- 3 xhur ta' qabel, pazjenti bi storja medika ta' mard tromboembolitiku venuż fis- 6 xhur ta' qabel, jew pazjenti b'kanċer attiv (ara sezzjonijiet 4.2
English: The pharmacokinetics of fondaparinux sodium are derived from fondaparinux plasma concentrations quantified via anti factor Xa activity.
Maltese: Il-farmakokinetika ta' fondaparinux sodium hija miġbura minn konċentrazzjonijiet ta' fondaparinux fil-plażma mkejlin permezz ta' attivita` kontra fattur Xa.
English: The dose should be reduced to 1.5 mg once daily in patients with creatinine clearance in the range of 20 to 50 ml/min (see sections 4.4 and 5.2).
Maltese: F'pazjenti bi clearance tal-krejatinina ta' bejn 20 sa 50 ml/min, id-doża ta' fondaparinux għandha titnaqqas għal 1.5 mg darba kuljum (ara sezzjonijiet 4.4 u 5.2).
English: EU/1/02/206/029 - 2 pre-filled syringes with a manual safety system EU/1/02/206/030 - 10 pre-filled syringes with a manual safety system EU/1/02/206/034 - 20 pre-filled syringes with a manual safety system
Maltese: EU/1/02/206/029 - 2 siringi mimlijin lesti b'sistema manwali ta' sigurtà EU/1/02/206/030 - 10 siringi mimlijin lesti b'sistema manwali ta' sigurtà EU/1/02/206/034 - 20 siringi mimlijin lesti b'sistema manwali ta' sigurtà
English: A randomised, double blind, clinical trial (CALISTO) included 3002 patients with acute symptomatic isolated, spontaneous superficial-vein thrombosis of the lower limbs, at least 5 cm long, confirmed by compression ultrasonography.
Maltese: Kura ta' pazjenti bi trombożi akuta, spontanja u sintomatika fil-vini superfiċjali mingħajr Trombożi fil-Vini tal-Fond (DVT) flimkien magħha Prova klinika randomised u double blind (CALISTO) kienet tinkludi 3002 pazjenti bi trombożi akuta, sintomatika, iżolata u spontanja fil-vini superfiċjali tar-riġlejn, li tkun mill-anqas twila 5 ċm u kkonfermata permezz ta' ultrasonografija ta' kompressjoni.
English: EU/1/02/206/021 - 2 pre-filled syringes with a manual safety system EU/1/02/206/022 - 10 pre-filled syringes with a manual safety system EU/1/02/206/023 - 20 pre-filled syringes with a manual safety system
Maltese: EU/1/02/206/021 - 2 siringi mimlijin lesti b'sistema manwali ta' sigurtà EU/1/02/206/022 - 10 siringi mimlijin lesti b'sistema manwali ta' sigurtà EU/1/02/206/023 - 20 siringi mimlijin lesti b'sistema manwali ta' sigurtà
English: • stomach pain
Maltese: • uġigħ fis-sider
English: Twelve (0.37%) enrolled patients experienced thrombus in the arterial sheath, of these 7 were reported during angiography and 5 were reported during PCI.
Maltese: Tnax (0.37%) mill-pazjenti mdaħħlin fl-istudju kellhom trombus fil-kisja tal-arterja, minn dawn 7 kienu rrappurtati waqt anġjografija u 5 kienu rrappurtati waqt PCI.
English: By Day 30, the incidence of all cause mortality was significantly reduced from 3.5% on enoxaparin to 2.9% on fondaparinux (hazard ratio 0.83, 95% CI, 0.71;0.97, p = 0.02).
Maltese: mewt/re-MI f'Jum 30 ma kienux statistikament differenti: rispettivament, 8.3% vs 8.7% (hazard ratio 0.94, 95% CI, 0.79, 1.11 p = 0.460).
English: The efficacy findings and results on severe haemorrhage were consistent across prespecified subgroups such as elderly, renally impaired patients, type of concomitant platelet aggregation inhibitors (aspirin, thienopyridines).
Maltese: Dak li nstab dwar effikaċja u r-riżultati dwar emorraġija qawwija kienu konsistenti fis-sottogruppi speċifikati minn qabel, bħall-anzjani, pazjenti b'indeboliment tal-kliewi, t-tip ta' impedituri konkomitanti kontra l-aggregazzjoni tal-plejtlets (aspirina, thienopyridines).
English: Bleeding risk is increased with concomitant administration of fondaparinux and agents that may enhance the risk of haemorrhage (see section 4.4).
Maltese: Interazzjoni ma' prodotti mediċinali oħra u forom oħra ta' interazzjoni Ir-riskju ta' fsada jiżdied bl-amministrazzjoni konkomitanti ta' fondaparinux u aġenti li jistgħu jżidu rriskju ta' emorraġija (ara sezzjoni 4.4).
English: EXP
Maltese: sinkope
English: METHOD OF ADMINISTRATION EXPIRY DATE
Maltese: DATA TA' REVIŻJONI TAT-TEST
English: Prevention of Venous Thromboembolic Events (VTE) in patients undergoing major orthopaedic surgery of the lower limbs treated up to 9 days
Maltese: Pożoloġija Pazjenti li jgħaddu minn kirurġija maġġuri ortopedika u addomenali
English: Common: bleeding (haematoma, haematuria, haemoptysis, gingival bleeding) Uncommon: anaemia
Maltese: Komuni: fsada (ematoma, ematurja, emoptisis, fsada tal ħanek)
English: Mean (CV%) steady state pharmacokinetic parameters estimates of fondaparinux in patients undergoing hip replacement surgery receiving fondaparinux 2.5 mg once daily are: Cmax (mg/l) - 0.39 (31%), Tmax (h) - 2.8 (18%) and Cmin (mg/l) -0.14 (56%).
Maltese: L-estimi medji (CV%) tal-parametri farmakokinetiċi fissi ta' fondaparinux f'pazjenti li jgħaddu minn kirurġija tat-tibdil fil-għadma tal- ġenbejn li jieħdu Arixtra 2.5mg kuljum huma : Cmax (mg/l) - 0.39
English: Paediatric patients - Fondaparinux has not been investigated in this population for the prevention of VTE or for the treatment of superficial vein thrombosis.
Maltese: Pazjenti pedjatriċi - Fondaparinux ma ġiex investigat f' din il-popolazzjoni għall-prevenzjoni ta' VTE jew għall-kura ta' trombożi fil-vini superfiċjali.
English: The duration of treatment should not exceed that evaluated during clinical trial (mean 7 days) (see sections 4.2, 4.3 and 5.2).
Maltese: It-tul tat-trattament m' għandux jiżboq dak studjat waqt il-prova klinika (medda ta' 7 t' ijiem) (ara sezzjonijiet 4.2, 4.3 u 5.2).
English: However, the use of fondaparinux should be considered with caution because of an increased risk of bleeding due to a deficiency of coagulation factors in patients with severe hepatic impairment (see section 4.2).
Maltese: Izda, l-użu ta' fondaparinux għandu jiġi kkunsidrat b'kawtela minħabba riskju akbar ta' fsada minħabba nuqqas ta' fatturi koagulanti f'pazjenti b'indeboliment epatiku qawwi (ara sezzjoni 4.2).
English: For treatment of UA/NSTEMI and STEMI-Fondaparinux should be used with caution in patients who are being treated concomitantly with other agents that increase the risk of haemorrhage (such as GPIIb/IIIa inhibitors or thrombolytics).
Maltese: Fit-trattament ta' UA/NSTEMI u STEMI - Fondaparinux għandu jintuża b'kawtela f'pazjenti li qed jirċievu fl-istess ħin aġenti oħra li jżidu r-riskju ta' emorraġija (bħal inibituri GP IIb/IIIa jew trombolitiċi).
English: Uncommon: headache Rare: dizziness
Maltese: Mhux komuni: uġigħ, edema
English: The recommended dose of fondaparinux is 2.5 mg once daily administered by subcutaneous injection.
Maltese: Id-doża rakkomandata ta' fondaparinux hi ta' 2.5 mg darba kuljum b'injezzjoni subkutanja.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Arixtra 10 mg/0.8 ml injection fondaparinux Na
Maltese: Arixtra 10 mg/0.8 ml soluzzjoni għall-injezzjoni fondaparinux Na
English: In the predefined stratum comparing fondaparinux to UFH (patients treated with primary PCI (58.5%), fibrin-specific lytics (13%), non-fibrin-specific lytics (2.6%) and no reperfusion (25.9%), the effects of fondaparinux and UFH on the incidence of death/re-MI at Day 30 were not statistically different: respectively, 8.3% vs 8.7% (hazard ratio 0.94, 95% CI, 0.79, 1.11 p = 0.460).
Maltese: 93, p = 0.003). Fost il-pazjenti li għall-bidu ma kienux riperfużi, l-inċidenza ta' mewt/re-MI tnaqqset b'mod sinifikanti fit-30 jum minn 15% fil-grupp ta' kontroll għal 12.1% filgrupp fondaparinux (hazard ratio 0.79, 95% CI, 0.65;0.97, p = 0.023). F'pazjenti trattati b'PCI primarja l-inċidenza ta' mewt/re-MI fit-30 jum ma kienitx statistikament differenti bejn iż-żewġ gruppi (6.0% fil-grupp fondaparinux kontra 4.8% fil-grupp ta' kontroll; hazard ratio 1.26, 95% CI,
English: Prophylaxis of VTE - Fondaparinux should not be used in patients with creatinine clearance <20 ml/min (see section 4.3).
Maltese: • Profilassi ta' VTE - Fondaparinux m'għandux jingħata lil pazjenti bi clearance tal-krejatinina < 20 ml/min (ara sezzjoni 4.3).
English: At the end of this period, 656 patients were randomised to receive fondaparinux 2.5 mg once daily or placebo for an additional 21 +/- 2 days.
Maltese: Fit-tmiem ta' dan il-perijodu, 656 pazjent ġew magħżula b'mod randomised biex jirċievu fondaparinux 2.5 mg darba kuljum jew plaċebo għal 21+/-2 ġranet addizzjonali.
English: Patients with Heparin Induced Thrombocytopenia
Maltese: • dijareja jew stitikezza
English: Fondaparinux was administered at an initial dose of 0.1 mg/kg subcutaneously once daily and dosing was adjusted to achieve peak fondaparinux sodium concentrations of 0.5 to 1 mg/L after 4 hours.
Maltese: Fondaparinux ingħata f'doża inizjali ta' 0.1 mg/kg taħt il-ġilda darba kuljum u l-għoti tad doża kien aġġustat biex jinkisbu l-ogħla konċentrazzjonijiet ta' 0.5 sa 1 mg/L ta' fondaparinux sodium fis-serum wara 4 sigħat.
English: The fondaparinux dose (10 mg) in the interaction studies was higher than the dose recommended for the present indications.
Maltese: Id-doża ta' fondaparinux (10 mg) fl-istudju ta' l-interazzjoni kienet ogħla mid-doża rakkomandata għall-indikazzjoni preżenti.
English: Clinically relevant non major bleeding occurred in 5 (0.3%) fondaparinux patients and 8 (0.5%) placebo patients.
Maltese: Fsada mhux serja iżda klinikament rilevanti seħħet f'5 (0.3%) pazjenti ta' fondaparinux u
English: Fondaparinux should be used with caution in patients who have an increased risk of haemorrhage (see section 4.4).
Maltese: Fondaparinux għandu jintuża b'kawtela f'pazjenti li għandhom riskju ogħla ta'emorraġija (ara sezzjoni 4.4).
English: Clinical experience is limited in patients with body weight <50 kg. Fondaparinux should be used with caution at a daily dose of 5 mg in this population (see sections 4.2 and 5.2).
Maltese: L-esperjenza klinika hija limitata f'pazjenti b' piż < 50 kg. Fondaparinux f'doża ta' 5mg kuljum għandu jintuża b'attenzjoni f' dan il-grupp ta' pazjenti (ara sezzjoni 4.2 u 5.2).
English: These may affect up to 1 in every 1000 people treated with Arixtra.
Maltese: Dawn jistgħu jaffettwaw sa 1 minn kull 1000 persuna trattati b'Arixtra:
English: Treatment of adults with acute Deep Vein Thrombosis (DVT) and treatment of acute Pulmonary Embolism (PE), except in haemodynamically unstable patients or patients who require thrombolysis or pulmonary embolectomy.
Maltese: It-trattament ta' adulti bi Trombożi akuta f'Vina Fonda (DVT) u t-trattament ta' Emboliżmu Pulmonari (PE) akut, ħlief f'pazjenti li huma emodinamikament instabli jew f'pazjenti li għandhom bżonn tromboliżi jew embolektomija.
English: Arixtra syringe may contain latex
Maltese: Kif jidher Arixtra u l-kontenut tal-pakkett:
English: Uncommon: nausea, vomiting Rare: abdominal pain, dyspepsia, gastritis, constipation, diarrhoea
Maltese: Mhux komuni:telf ta' demm (epistaxis, emoptisis gastrointestinali, ematurja, ematoma)
English: Peri-PCI minor bleeding
Maltese: Doża li s-soltu tingħata
English: Treatment of unstable angina or non-ST segment elevation myocardial infarction (UA/NSTEMI) in adultsfor whom urgent (< 120 mins) invasive management (PCI) is not indicated (see sections 4.4 and 5.1).
Maltese: Għandha tittieħed attenzjoni bl-użu ta' fondaparinux f'pazjenti b'indeboliment sever tal-fwied għaliex dan il-grupp ta' pazjenti ma ġiex studjat (ara sezzjonijiet 4.4 u 5.2).
English: Patients undergoing major orthopaedic or abdominal surgery The recommended dose of fondaparinux is 2.5 mg once daily administered post-operatively by subcutaneous injection.
Maltese: Id-doża rakkomandata ta' Arixtra hi ta' 2.5 mg darba kuljum amminisrata wara l-operazzjoni permezz ta' injezzjoni subkutanja.
English: If fondaparinux sodium is added to a 0.9% saline minibag it should ideally be infused immediately, but can be stored at room temperature for up to 24 hours.
Maltese: Jekk fondaparinux sodium jiġi miżjud ma' saline 0.9% f'borża żgħira, għandu idejalment jingħata permezz ta' infużjoni immedjatament, imma jista' jinħażen f'temperatura ambjentali sa 24 siegħa.
English: Aspen Pharma Trading Limited Tel.: 008001211566/+44 (0)1423 852 859 aspenmedinfo@professionalinformation.co.uk
Maltese: Aspen Pharma Trading Limited Tél/Tel: 0035 227861279 aspenmedinfo@professionalinformation.co.uk
English: Patients with creatinine clearance <50 ml/min are at increased risk of bleeding and VTE and should be treated with caution (see sections 4.2, 4.3 and 5.2).
Maltese: Pazjenti bi clearance tal-krejatinina ta' < 50 ml/min għandhom riskju akbar ta' fsada u VTE w għandhom jiġu trattati b'kawtela (ara sezzjonijiet 4.2, 4.3 u 5.2).
English: Fondaparinux should be used with caution in these patients (see section 4.2).
Maltese: fondaparinux (ara sezzjoni 5.2).
English: aspenmedinfo@professionalinformation.co.uk aspenmedinfo@professionalinformation.co.uk Ireland
Maltese: 316301169 aspenmedinfo@professionalinformation.co.uk
English: Aspen Pharma Trading Limited Tlf: 80010093/+44 (0)1423 852 995 aspenmedinfo@professionalinformation.co.uk
Maltese: Aspen Pharma Trading Limited Tel: 0039 0687502429 aspenmedinfo@professionalinformation.co.uk
English: How to store Arixtra
Maltese: Kemm għandek iddum tieħu Arixtra
English: The mortality benefit shown in the fondaparinux group was maintained until the end of follow-up at Day 180.
Maltese: Il-benefiċċji ta' mortalita' li ntwera fil grupp fondaparinux baqgħet hekk sa l-aħħar ta' l-insegwiment fil-180 jum .
English: In subjects randomized to the “standard dose UFH” or the “low dose UFH” regimen the median dose of UFH was 85 U/kg and 50 U/kg, respectively.
Maltese: (doża medjana ta' 85U/kg) jew “doża baxxa ta' UFH” (doża medjana ta' 50U/kg).
English: Treatment of Deep Venous Thrombosis
Maltese: Trattament ta' Trombożi f'Vina Fonda
English: Rare: dyspnoea, coughing
Maltese: indiġestjoni, gastrite, stitikezza,
English: Each pre-filled syringe contains 10 mg of fondaparinux sodium in 0.8 ml solution for injection.
Maltese: Kull siringa mimlija lesta fiha 10 mg ta' fondaparinux sodium f' 0.8 ml ta' soluzzjoni għall-injezzjoni.
English: Treatment of ST segment elevation myocardial infarction (STEMI) in adults who are managed with thrombolytics or who initially are to receive no other form of reperfusion therapy.
Maltese: Trattament ta' infart mijokardijaku b'elevazzjoni tas-segment ST (STEMI) f'adulti li qed jirċievu trattament b'trombolitiċi jew f'dawk li inizjalment m'għandhomx jirċievu l-ebda forma oħra ta' terapija ta' riperfużjoni.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Subcutaneous use
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I)
English: Hepatic impairment
Maltese: Indeboliment epatiku qawwi
English: The safety of fondaparinux has been evaluated in 2,517 patients treated for Venous ThromboEmbolism and treated with fondaparinux for an average of 7 days.
Maltese: Is-sigurtà ta' fondaparinux 2.5 mg ġiet evalwata f'2,517 pazjent li kienu fuq trattament b' fondaparinux għal medja ta' 7 t' ijiem għal Trombo-Emboliżmu Venuż.
English: Aspen Pharma Trading Limited Τηλ: 80096374/+44 (0)1423 852 990 aspenmedinfo@professionalinformation.co.uk
Maltese: Aspen Pharma Trading Limited Tel: 00356 21497982 aspenmedinfo@professionalinformation.co.uk
English: EMA/CHMP/896315/2011 EMEA/H/C/002140
Maltese: EMEA/H/C/002140
English: The company that applied for authorisation is Galpharm Healthcare Ltd.
Maltese: Il-kumpanija li applikat għall-awtorizzazzjoni hija Galpharm Healthcare Ltd.
English: 17 November 2011
Maltese: 17 ta' Novembru 2011 EMA/907378/2011
English: What is Sumatriptan Galpharm?
Maltese: X'inhu Sumatriptan Galpharm?
English: It was to be available as 50 mg tablets.
Maltese: Kellu jinbiegħ fl-għamla ta' pilloli ta' 50 mg.
English: The CHMP therefore confirmed its initial negative opinion.
Maltese: Għaldaqstant is-CHMP ikkonferma l-opinjoni negattiva inizjali tiegħu.
English: Sumatriptan Galpharm is a medicine that contains the active substance sumatriptan.
Maltese: Sumatriptan Galpharm huwa mediċina li fiha s-sustanza attiva sumatriptan.
English: Refusal of the marketing authorisation for Sumatriptan Galpharm 50 mg tablets
Maltese: Rifjut tal-awtorizzazzjoni għat-tqegħid fis-suq għall-pilloli Sumatriptan Galpharm 50 mg
English: Refusal of the marketing authorisation for Sumatriptan Galpharm 50 mg tablets EMA/CHMP/896315/2011
Maltese: Rifjut tal-awtorizzazzjoni għat-tqegħid fis-suq għall-pilloli Sumatriptan Galpharm 50 mgEMA/159010/2012
English: Sumatriptan Galpharm was expected to work in the same way as the reference medicine, Imigran.
Maltese: Sumatriptan Galpharm kien mistenni li jaħdem bl-istess mod bħall-mediċina ta' referenza, Imigran.
English: The additional measures proposed by the company were still considered insufficient.
Maltese: Ilmiżuri addizzjonali li pproponiet il-kumpanija baqgħu jitqiesu insuffiċjenti.
English: After considering the grounds for this request, the CHMP re-examined the initial opinion, and confirmed the refusal of the marketing authorisation on 17 November 2011.
Maltese: Wara li kkunsidra r-raġunijiet ta' din it-talba, is-CHMP għamel eżaminazzjoni mill-ġdid tal-opinjoni inizjali, u kkonferma r-rifjut talawtorizzazzjoni għat-tqegħid fis-suq fis-17 ta' Novembru 2011.
English: On 21 July 2011, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Sumatriptan Galpharm, intended for the relief of migraine attacks in people who have been diagnosed with migraine.
Maltese: Fil-21 ta' Lulju 2011, il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) adotta opinjoni negattiva, u rrakkomanda r-rifjut tal-awtorizzazzjoni għat-tqegħid fis-suq għall-prodott mediċinali Sumatriptan Galpharm, maħsub biex itaffi l-attakki ta' emigranja f'persuni li ġew iddijanjostikati li jbatu mill-emigranja.
English: Sumatriptan Galpharm was intended to be similar to a ‘reference medicine' already authorised in the European Union called Imigran.
Maltese: Sumatriptan Galpharm kien maħsub li jkun simili għal ‘mediċina ta' referenza' bl-isem ta' Imigran li diġà hija awtorizzata fl-Unjoni Ewropea.
English: This was because a lack of medical supervision and monitoring of the patient would increase the risk for cerebrovascular (brain) and cardiovascular (heart) side effects and potential misuse and overuse.
Maltese: Dan għaliex in-nuqqas ta' sorveljanza medika u monitoraġġ talpazjent iżid ir-riskju ta' effetti sekondarji ċerebrovaskulari (fil-moħħ) u kardjovaskulari (fil-qalb) u lpossibbiltà li jintuża ħażin u b'mod eċċessiv.