FrancophonIA/ELRC3.0 huggingface dataset:
English: - Anaphylaxis: Refludan may cause allergic reactions including anaphylaxis and shock (see section 4.8).
Maltese: Refludan jista' jikkawża reazzjonijiet allerġiċi inklż anafilassi u xokk (ara sezzjoni 4.8).
English: Reported bleeding events include: anaemia or drop in the haemoglobin value without obvious source of bleeding, bruising, bleeding from puncture sites, nose bleeding, blood in urine, gastrointestinal bleeding, vaginal bleeding, rectal bleeding, pulmonary haemorrhage, bleeding into chest space and around the heart following surgery, bleeding into the brain.
Maltese: Episodji ta' fsada rrappurtati jinkludu: anemija jew tnaqqis fil-valur tal-emoglobina mingħajr post ovvju ta' fsada, tbenġil, fsada minn postijiet ta' titqib, fsada mill-imnieħer, demm fl-awrina, fsada gastro-intestinali, fsada mill-vaġina, fsada mir-rektum, emorraġijja pulmonari, fsada fl-ispazju ta' ġewwa tas-sider u madwar il-qalb wara kirurġija, fsada fil-moħħ.
English: The systemic clearance of lepirudin decreases in proportion to the existing glomerular filtration rate.
Maltese: It-tneħħija sistemika ta' lepirudin tonqos f'proporzjon mar-rata ta' filtrazzjoni glomerulari eżistenti.
English: Refludan is available in packs of 1 or 10 vials.
Maltese: Refludan huwa disponibbli f'pakketti ta' kunjett wieħed jew 10 kunjetti.
English: In a standard embryo-foetal toxicity trial, decreased pup and maternal survival was observed.
Maltese: Fi prova stàndard ta' tossiċità fuq l-embriju/fetu, kien osservat tnaqqis fis-sopravvivenza tal-ferħ u talomm.
English: Table 1: Reduction of infusion rate in patients with renal impairment
Maltese: Tabella 1: Tnaqqis tar-rata ta' infużjoni f'pazjenti b'indeboliment tal-kliewi
English: 1 vial contains 20 mg lepirudin.
Maltese: Kull fjala fiha 20 mg lepirudin.
English: The infusion rate must be reduced according to table 1.
Maltese: Ir-rata ta' infużjoni għandha tiġi mnaqqsa skond tabella 1.
English: - Experience of combined therapy with thrombolytic agents in patients with HIT type II is very limited.
Maltese: - Esperjenza ta' terapija kombinata ma' aġenti trombolitiċi f'pazjenti b'HIT tat-tip II hija limitata ħafna.
English: 1 vial contains 50 mg lepirudin.
Maltese: Kull fjala fiha 50 mg lepirudin.
English: The majority of undesirable effects experienced by patients treated with Refludan were generally related to bleeding (>1/10).
Maltese: Il-maġġoranza ta' effetti mhux mixtieqa li esperjenzaw il-pazjenti kkurati b'Refludan kienu ġeneralment relatati ma' fsada (> 1/10).
English: Reconstitute one vial (20 mg of lepirudin) with 0.4 ml of either water for injections or sodium chloride 9 mg/ml (0.9 %) solution.
Maltese: Irrikonstitwixxi kunjett wieħed (20 mg ta' lepirudin) b' 0.4 ml jew ta' ilma għall-injezzjoni jew ta' soluzzjoni ta' sodium chloride 9 mg/ml (0.9 %).
English: <EXP {MM/YYYY}>
Maltese: JIS {MM/YYYY}
English: - The first aPTT determination should be done 4 hours after start of Refludan therapy.
Maltese: - L-ewwel determinazzjoni ta' aPTT għandha ssir 4 siegħat wara l-bidu ta' terapija b'Refludan.
English: Therefore, the bolus dose and infusion rate must be reduced in case of known or suspected renal insufficiency (creatinine clearance below 60 ml/min or creatinine value above 15 mg/l [133 mol/l]).
Maltese: Għalhekk, id-doża bolus u r-rata ta' infużjoni iridu jitnaqqsu f'każ ta' insuffiċjenza tal-kliewi magħrufa jew issuspettata (tneħħija ta' kreatinina taħt 60 ml/min jew valur ta' kreatinina aktar minn 15 mg/l [133 mol/l]).
English: - The final solution is to be administered in a body weight-dependent fashion (see section 4.2).
Maltese: - Is-soluzzjoni finali trid tiġi amministrata b'mod dipendenti mill-piż tal-ġisem (ara sezzjoni 4.2).
English: - Elderly: Patients of advanced age have an increased risk of bleeding complications with anticoagulation.
Maltese: - Anzjani: Pazjenti b'età avvanzata għandhom riskju akbar ta' kumplikazzjonijiet ta' fsada b'antikoagulazzjoni.
English: - 0.4 mg / kg body weight intravenously as a bolus dose - followed by 0.15 mg / kg body weight / hour as a continuous intravenous infusion for 2 - 10
Maltese: - 0.4 mg / kg piż tal-ġisem ġol-vina bħala doża bolus - segwit minn 0.15 mg / kg piż tal-ġisem / siegħa bħala infużjoni kontinwa ġol-vina għal 2 - 10
English: Reconstitute the lyophilisate as described in section 6.6.
Maltese: Irrikostitwixxi il-lijofilizzat kif deskritt f'sezzjoni 6.6.
English: Monitoring and modification of the Refludan dosage regimen
Maltese: Sorveljanza u modifikazzjoni tal-kors ta' dożaġġ ta' Refludan
English: Dosage 0.2 mg / kg body weight
Maltese: Dożaġġ 0.4 mg / kg piż tal-ġisem Dożaġġ 0.2 mg / kg piż tal-ġisem
English: Its activity is measured in a chromogenic assay.
Maltese: L-attività tiegħu hija mkejjla minn assay kromoġeniku.
English: Each vial contains 20 mg lepirudin.
Maltese: Kunjett wieħed fih 20 mg lepirudin.
English: avoid or STOP infusion !
Maltese: Evita jew WAQQAF l-infużjoni !*
English: Chills
Maltese: Dalton.
English: Injection volume [ml]
Maltese: Volum ta' l-injezzjoni [ml]
English: In patients with terminal renal insufficiency prolonged elimination half-lives of about 2 days were observed.
Maltese: F'pazjenti b'insuffiċjenza tal-kliewi terminali kienu osservati half-lives ta' eliminazzjoni mtawwla ta' madwar jumejn.
English: To avoid prothrombotic effects when initiating coumarin, continue parenteral anticoagulation for 4 to 5 days (see oral anticoagulant package insert for information).
Maltese: Sabiex jiġu evitati effeti protrombotiċi meta jinbeda coumarin, l-antikoagulazzjoni parenterali għandha titkompla għal 4 sa 5 ijiem (ara l-fuljett ta' tagħrif ta' lantikoagulant mill-ħalq għal aktar informazzjoni).
English: Refludan is used for anticoagulation in adult patients with heparin-induced thrombocytopenia (HIT) type II and thromboembolic disease requiring injected antithrombotic medicines.
Maltese: Refludan huwa wżat għal antikoagulazzjoni f'pazjenti adulti bi tromboċitopenija indotta mill-eparina (HIT) tat-tip II u mard tromboembolitiku li jeħtieġ mediċini antitrombolitiċi mogħtija bħala injezzjoni.
English: Preparation of a Refludan solution with a concentration of 5 mg/ml For intravenous bolus injection a solution with a concentration of 5 mg/ml is needed: - Reconstitute one vial (20 mg of lepirudin) with 0.4 ml of either water for injections or sodium chloride 9 mg/ml (0.9 %) solution.
Maltese: Preparazzjoni ta' soluzzjoni ta' Refludan b'konċetrazzjoni ta' 5 mg/ml Għall-injezzjoni bolus ġol-vina, hija meħtieġa soluzzjoni b'konċetrazzjoni ta' 5 mg/ml: - Irrikostitwixxi kunjett wieħed (20 mg ta' lepirudin) b'0.4 ml ta' imla għall-injezzjoni jew soluzzjoni ta' sodium chloride 9 mg/ml (0.9 %).
English: Preparation of a Refludan solution with a concentration of 5 mg/ml For intravenous bolus injection a solution with a concentration of 5 mg/ml is needed: - Reconstitute one vial (50 mg of lepirudin) with 1 ml of either water for injections or sodium chloride 9 mg/ml (0.9 %) solution.
Maltese: Preparazzjoni ta' soluzzjoni ta' Refludan b'konċetrazzjoni ta' 5 mg/ml Għall-injezzjoni bolus ġol-vina, hija meħtieġa soluzzjoni b'konċetrazzjoni ta' 5 mg/ml: - Irrikostitwixxi kunjett wieħed (50 mg ta' lepirudin) b'1 ml ta' imla għall-injezzjoni jew soluzzjoni ta' sodium chloride 9 mg/ml (0.9 %).
English: Refludan 20 mg powder for solution for injection or infusion lepirudin
Maltese: Refludan 20 mg trab għal soluzzjoni għall-injezzjoni jew infużjoni lepirudin
English: Lepirudin is a highly specific direct inhibitor of thrombin.
Maltese: Lepirudin huwa inibitur dirett speċifiku ħafna ta' thrombin.
English: Refludan 50 mg powder for solution for injection or infusion lepirudin
Maltese: Refludan 50 mg trab għal soluzzjoni għall-injezzjoni jew infużjoni Lepirudin
English: Refludan 50 mg powder for solution for injection or infusion Lepirudin
Maltese: Refludan 50 mg trab għal soluzzjoni għall-injezzjoni jew infużjoni lepirudin
English: - In general, an infusion rate of 0.21 mg/kg/hour should not be exceeded without checking for coagulation abnormalities which might be preventing an appropriate aPTT response.
Maltese: - Ġeneralment, rata ta' infużjoni ta' 0.21 mg/kg/siegħa m'għandiex tinqabeż mingħajr ma jsir kontroll għall-abnormalitajiet fil-koagulazzjoni li jistgħu jkunu qed jipprevjenu rispons xieraq ta' aPTT.
English: Additionally, individual case reports and in-vitro data suggest that either haemofiltration or haemodialysis (using high flux dialysis membranes with a cut-off point of 50,000 Dalton) may be useful in this situation.
Maltese: Barra minn hekk, rapporti ta' każi individwali u tagħrif in-vitro jissuġġerixxu li emofiltrazzjoni jew emodijaliżi (bl-użu ta' membrani tad-dijaliżi high flux b'cut-off point ta' 50,000 Dalton) jistgħu jkunu ta' għajnuna f'din is-sitwazzjoni.
English: In patients with a body weight exceeding 110 kg the dosage should not be increased beyond the 110 kg body weight dose (see also tables 2 and 3, below).
Maltese: F'pazjenti b'piż tal-ġisem aktar minn 110 kg id-dożaġġ m'għandux jiġi miżjud aktar mid-doża ta' 110 kg piż tal-ġisem (ara wkoll tabelli 2 u 3, isfel).
English: Antibodies against hirudin which appeared in several of the treated monkeys resulted in prolongation of the terminal half-life and an increase in systemic exposure to lepirudin.
Maltese: Antikorpi kontra hirudin li dehru f'ħafna mix-xadini kkurati wassal għal titwil tal-half-life terminali u żieda flespożizzjoni sistemika għal lepirudin.
English: At restart, the infusion speed should be decreased by 50 % (no additional intravenous bolus should be administered).
Maltese: Meta terġa' tinbeda, il-veloċità ta' l-infużjoni għandha titnaqqas b'50 % (m'għandu jingħata l'ebda bolus addizzjonali ġol-vina).
English: The aPTT should be determined again 4 hours later.
Maltese: L'aPTT għandu jerġa' jiġi ddeterminat 4 sigħat wara.
English: No evidence of a neutralisation of lepirudin or of an allergic reaction associated with the positive antibody test results was found.
Maltese: Ma nstabet l-ebda evidenza tan-newtralizazzjoni ta' lepirudin jew ta' reazzjoni allerġika assoċjata ma' riżultati posittivi ta' test ta' l-antikorpi.
English: Anticoagulation in adult patients with HIT type II and thromboembolic disease:
Maltese: Antikoagulazzjoni f'pazjenti adulti b'HIT tat-tip II u mard tromboembolitiku:
English: The pharmacokinetic properties of lepirudin following intravenous administration are well described by a two-compartment model.
Maltese: La darba rikostitwit, Rifludan għandu jintuża mmedjatament.
English: Reconstitute one vial (50 mg of lepirudin) with 1 ml of either water for injections or sodium chloride 9 mg/ml (0.9 %) solution.
Maltese: Irrikonstitwixxi kunjett wieħed (50 mg ta' lepirudin) b' 0.4 ml jew ta' ilma għall-injezzjoni jew ta' soluzzjoni ta' sodium chloride 9 mg/ml (0.9 %).
English: Creatinine clearance [ml/min]
Maltese: Tneħħija ta' keatinina [ml/min]
English: Adverse events reported on Refludan are shown in the table below:
Maltese: Effetti avversi rrappurtati fuq Refludan huma mniżżla fit-tabella hawn taħt:
English: Preparation of a Refludan solution with a concentration of 2 mg/ml For continuous intravenous infusion, a solution with a concentration of 2 mg/ml is needed: - Reconstitute two vials (each containing 20 mg of lepirudin) with 0.4 ml each using either water for injections or sodium chloride 9 mg/ml (0.9 %) solution.
Maltese: Preparazzjoni ta' soluzzjoni ta' Refludan b'konċetrazzjoni ta' 2 mg/ml Għall-infużjoni kontinwa ġol-vina, hija meħtieġa soluzzjoni b'konċetrazzjoni ta' 2 mg/ml: - Irrikostitwixxi żewġ kunjetti (kull wieħed fih 20 mg ta' lepirudin) b'0.4 ml kull wieħed billi tuża ilma għall-injezzjoni jew soluzzjoni ta' sodium chloride 9 mg/ml (0.9 %).
English: Intravenous infusion:
Maltese: Preżentazzjonijiet:
English: Refludan, once reconstituted with an appropriate solvent, will be administered into a vein, by injection and then by infusion.
Maltese: Refludan, la darba jiġi rikostitwit b'solvent xieraq, jingħata ġo vina permezz ta' injezzjoni u wara permezz ta' infużjoni.
English: single-use perfusor syringe (50 ml capacity) and further dilution to a total volume of 20 ml using sodium chloride 9 mg/ml (0.9 %) or glucose 5 % solution.
Maltese: - Il-konċetrazzjoni finali ta' 2 mg/ml tinkiseb billi jiġu trasferiti iż-żewġ soluzzjonijiet ġo siringa perfusor sterili waħda, li tintuża darba biss (kapaċità ta' 50 ml) u aktar dilwazzjoni sa volum totali ta' 20 ml permezz ta' soluzzjoni ta' sodium chloride 9 mg/ml (0.9 %) jew glucose 5 %.
English: - For reconstitution water for injections or sodium chloride 9 mg/ml (0.9 %) solution are to be used.
Maltese: - Għar-rikostituzzjoni għandhom jintużaw ilma għall-injezzjoni jew soluzzjoni ta' sodium chloride 9 mg/ml (0.9 %).
English: Moreover, in rats slight to moderate sinushistiocytosis of the regional lymph nodes and decreased haemosiderin deposits in the spleen were observed.
Maltese: OĦRA, JEKK MEĦTIEĠA Is-soluzzjoni rikonstitwita għandha tintuża mmedjatament.
English: - For further dilution, sodium chloride 9 mg/ml (0.9 %) or glucose 5 % solutions are suitable.
Maltese: - Għal aktar dilwazzjoni, soluzzjonijiet ta' sodium chloride 9 mg/ml (0.9 %) jew glucose 5 %
English: OUTER CARTON: 50 mg x 1 VIAL
Maltese: PAKKETT TA' BARRA: 50 mg x KUNJETT WIEHED
English: As lepirudin is almost exclusively excreted and metabolised renally (see also section 5.2), the patient's renal function should be considered prior to administration.
Maltese: Minħabba li lepirudin jintrema u jiġi metabolizzat kważi esklussivament mill-kliewi (ara wkoll sezzjoni 5.2), il-funżjoni tal-kliewi tal-pazjent għandha tiġi kkunsidrata qabel l-amministrazzjoni.
English: single-use perfusor syringe (50 ml capacity) and further dilution to a total volume of 50 ml using sodium chloride 9 mg/ml (0.9 %) or glucose 5 % solution.
Maltese: - Il-konċetrazzjoni finali ta' 2 mg/ml tinkiseb billi jiġu trasferiti iż-żewġ soluzzjonijiet ġo siringa perfusor sterili waħda, li tintuża darba biss (kapaċità ta' 50 ml) u aktar dilwazzjoni sa volum totali ta' 50 ml permezz ta' soluzzjoni ta' sodium chloride 9 mg/ml (0.9 %) jew glucose 5 %.
English: Preparation of a Refludan solution with a concentration of 2 mg/ml For continuous intravenous infusion, a solution with a concentration of 2 mg/ml is needed: - Reconstitute two vials (each containing 50 mg of lepirudin) with 1 ml each using either water for injections or sodium chloride 9 mg/ml (0.9 %) solution.
Maltese: Preparazzjoni ta' soluzzjoni ta' Refludan b'konċetrazzjoni ta' 2 mg/ml Għall-infużjoni kontinwa ġol-vina, hija meħtieġa soluzzjoni b'konċetrazzjoni ta' 2 mg/ml: - Irrikostitwixxi żewġ kunjetti (kull wieħed fih 50 mg ta' lepirudin) b'1 ml kull wieħed billi tuża ilma għall-injezzjoni jew soluzzjoni ta' sodium chloride 9 mg/ml (0.9 %).
English: For intravenous bolus injection, a solution with a concentration of 5 mg/ml is needed.
Maltese: Għall-injezzjoni bolus ġol-vina, soluzzjoni b'konċentrazzjoni ta' 5 mg/ml hija meħtieġa.
English: Refludan 20 mg powder for solution for injection or infusion
Maltese: Refludan 20 mg trab għal soluzzjoni għall-injezzjoni jew infużjoni
English: Concomitant treatment with coumarin derivatives (vitamin K antagonists) and drugs that affect platelet function may also increase the risk of bleeding.
Maltese: Kura flimkien ma' derivati ta' coumarin (antagonisti tal-vitamina K) u mediċini li jaffettwaw il-funzjoni tal-plejtlets jistgħu wkoll jżidu ir-riskju ta' fsada.
English: What Refludan looks like and contents of the pack Refludan is a white powder for solution for injection or infusion supplied in a vial containing 20 mg lepirudin.
Maltese: Refludan huwa trab abjad għal soluzzjoni għall-injezzjoni jew infużjoni pprovdut f'kunjett li fih 20 mg lepirudin.
English: Its mode of action is independent of antithrombin III.
Maltese: Il-mod kif jaħdem huwa indipendenti minn antithrombin III. Platelet factor 4 ma jinibixxix lepirudin.
English: OUTER CARTON: 20 mg x 1 VIAL
Maltese: PAKKETT TA' BARRA: 20 mg x KUNJETT WIEĦED
English: Refludan 50 mg powder for solution for injection or infusion
Maltese: Refludan 50 mg trab għal soluzzjoni għall-injezzjoni jew infużjoni
English: Antithrombotics are medicines to prevent formation of blood clots (thrombosis).
Maltese: Antitrombolitiċi huma mediċini biex jipprevjenu l-formazzjoni ta' emboli (trombożi).
English: - The final concentration of 5 mg/ml is obtained by transfer into a sterile, single-use syringe (of at least 10 ml capacity) and further dilution to a total volume of 10 ml using sodium chloride
Maltese: - Il-konċentrazzjoni finali ta' 5 mg/ml hija miksuba billi jiġi trasferit ġo siringa sterili, li tintuża darba (b'kapaċità mill-inqas ta' 10 ml) u aktar dilwazzjoni sa volum totali ta' 10 ml bl-użu ta'
English: - The final concentration of 5 mg/ml is obtained by transfer into a sterile, single-use syringe (of at least 5 ml capacity) and further dilution to a total volume of 4 ml using sodium chloride 9
Maltese: - Il-konċentrazzjoni finali ta' 5 mg/ml hija miksuba billi jiġi trasferit ġo siringa sterili, li tintuża darba (b'kapaċità mill-inqas ta' 5 ml) u aktar dilwazzjoni sa volum totali ta' 4 ml bl-użu ta'
English: 2.8 Parallel distribution
Maltese: 2.8 Distribuzzjoni parallela
English: Totals:
Maltese: Totali:
English: of Directive 2001/83/EC
Maltese: tad-Direttiva 2001/83/KE
English: Professor Hannes Wahlroos
Maltese: Il-Professur Hannes Wahlroos
English: 300 originated within the EU.
Maltese: 300 oriġinaw fl-UE.
English: Generics, hybrid products, etc.
Maltese: Generici, prodotti ibridi, ecc.
English: EMEA/88802/2007/EN/FINAL
Maltese: EMEA/230192/2007/MT/FINALI
English: 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 84 09 E-mail: mail@emea.europa.eu http://www.emea.europa.eu
Maltese: (44-20) 74 18 84 00 Fax (44-20) 74 18 84 09 E-mail: mail@emea.europa.eu http://www.emea.europa.eu
English: Average number of days for centralised procedures,
Maltese: Numru medju ta' jiem ghal proceduri centralizzati,
English: Total Recalls Class 1 Class 2 Class 3
Maltese: 2 Klassi 3
English: Positive opinions
Maltese: Opinjonijiet pozittivi
English: 3.6 Arbitration and Community referrals
Maltese: 3.6 Arbitraġġ u referenzi Komunitarji
English: 1.7 Tackling antimicrobial resistance
Maltese: 1.7 Indirizzar tar-reżistenza antimikrobika
English: Review of PSURs
Maltese: Reviżjoni ta' PSURs
English: Neurology/CNS
Maltese: Newrologija/CNS
English: Musculo-skeletal
Maltese: Muskolu-skeletali
English: Neurology/Central nervous system
Maltese: Newrologija/Sistema nervuza centrali
English: Hormonal
Maltese: Ormoni
English: Orphan medicinal products
Maltese: Prodotti medicinali orfni
English: Applications received, 2004-2006
Maltese: Applikazzjonijiet ricevuti, 2004-2006
English: Confirmation of CVMP opinion on veterinary Cox-2s and NSAIDs
Maltese: Konferma ta' l-opinjoni tas-CVMP dwar Cox-2s u NSAIDs veterinarji
English: Article 5(3)
Maltese: L-Artikolu 5(3)
English: The Committee for Orphan Medicinal Products (COMP) adopted 81 positive opinions.
Maltese: Il-Kumitat għal Prodotti Mediċinali Orfni (COMP) adotta 81 opinjoni pożittiva.
English: Of the 681 such opinions adopted, 60% related to safety and efficacy, and 40% related to quality changes.
Maltese: Mis-681 tali opinjoni adottati, 60% huma relatati mas-sigurtà u l-effikaċja, u 40% relatati mal-bidliet fil-kwalità.
English: Dermatologicals
Maltese: Dermatologici
English: The number of initial parallel-distribution notifications received in 2006 was 1,408 (113% more than in 2005).
Maltese: In-numru ta' notifiki inizjali ta' distribuzzjoni parallela riċevuti fl-2006 kien 1,408 (113% aktar mill2005).
English: Average number of days for centralised procedures (positive opinions), 2004-2006
Maltese: Numru medju ta' jiem ghal proceduri centralizzati (opinjonijiet pozittivi), 2004-2006
English: Metabolism
Maltese: Metabolizmu
English: Article 6(12)
Maltese: L-Artikolu 6(12)
English: At the end of 2006, EudraVigilance contained a total of 677,976 individual-case-safety reports (ICSRs), corresponding to 409,138 individual cases.
Maltese: Fl-aħħar ta' l-2006, l-EudraVigilance kellha total ta' 677,976 rapport ta' sigurtà ta' każijiet individwali (ICSRs), li jikkorrispondu għal 409,138 każ individwali.
English: The first pandemic-influenza mock-up vaccine, containing the reverse genetic H5N1 strain.
Maltese: L-ewwel tilqima bi prova ta' l-influwenza pandemika, li fiha r-reverse genetic H5N1 strain.
English: To date, a total of 53,642 ICSRs, corresponding to 26,997 individual cases, have been transmitted to EVCTM.
Maltese: Sa llum, ġew trasmessi lill-EVCTM total ta' 53,642 ICSRs, li jikkorrispondu għal 26,997 każ individwali.
English: Cardiovascular and respiratory
Maltese: Kardjovaskulari u respiratorju
English: Positive opinions per therapeutic area (by ATC code), 2006
Maltese: Opinjonijiet pozittivi skond il-qasam terapewtiku (bil-kodici ATC), 2006
English: 4.1 GMP, GCP, pharmacovigilance and GLP inspections
Maltese: 4.1 GMP, GCP, farmakoviġilanza u spezzjonijiet tal-GLP
English: For centrally authorised veterinary products, a total of 738 expedited spontaneous reports of suspected adverse reactions were reported within the 15-day legal timeframe in 2006.
Maltese: Għal prodotti veterinarji awtorizzati ċentralment, ġew irrapportati total ta' 738 rapport spontanju mgħaġġlin ta' reazzjonijiet mhux mixtieqa suspettati, fil-limiti ta' 15-il jum matul l-2006.
English: of Regulation (EC) No 726/2004
Maltese: tar-Regolament (KE) Nru 726/2004
English: Article 29
Maltese: L-Artikolu 29
English: Total initial notifications received Payable initial notifications received Total initial notices issued
Maltese: Total ta' notifiki inizjali ricevuti
English: Of these, 14 concerned pharmaceutical products and 11 concerned immunological products.
Maltese: Minn dawn, 14 jikkonċernaw prodotti farmaċewtiċi u 11 jikkonċernaw prodotti immunoloġiċi.
English: Article 6(13)
Maltese: L-Artikolu 6(13)
English: Anti-infectious
Maltese: Anti-infettiv
English: A total of €6.7 million was granted to fund fee reductions for orphan medicines in 2006, primarily from the EU special contribution.
Maltese: Ingħata total ta' €6.7 miljun għall-finanzjament tat-tnaqqis fid-drittijiet għal mediċini orfni fl-2006, primarjament mill-kontribut speċjali ta' l-UE.
English: Immunotherapy and oncology
Maltese: Immunoterapija u onkologija
English: EudraVigilance and clinical trials
Maltese: L-EudraVigilance u provi kliniċi
English: New contra-indication for the use of PDE-5 inhibitors in patients suffering from vision loss in one eye because of non-arteritic anterior ischemic optic neuropathy.
Maltese: Kontra-indikazzjoni ġdida għall-użu ta' inibituri PDE-5 f'pazjenti li jsofru minn telf tal-vista f'għajn waħda minħabba n-non-arteritic anterior ischemic optic neuropathy.
English: The EMEA Management Board met four times in 2006, under chairman Hannes Wahlroos, from Finland, and vice-chairman Jytte Lyngvig, from Denmark.
Maltese: Il-Bord ta' Tmexxija ta' l-EMEA ltaqa' erba' darbiet fl-2006, taħt il-president Hannes Wahlroos, millFinlandja, u l-viċi-president Jytte Lyngvig, mid-Danimarka.
English: 1.6 Pandemic-influenza preparedness
Maltese: 1.6 Tħejjija għall-influwenza pandemika
English: Musculoskeletal and nervous system
Maltese: Sistema muskoluskeletali u nervuza
English: Article 30
Maltese: L-Artikolu 30
English: 1.3 Information and communication
Maltese: 1.3 Informazzjoni u komunikazzjoni
English: EU contribution and fee revenue (€ million), 1995-2006
Maltese: Kontribut ta' l-UE u dhul minn mizati (€ miljuni), 1995-2006
English: A medicine for opioid-dependency-substitution treatment.
Maltese: Mediċina għas-sostituzzjoni tal-kura tad-dipendenza fuq l-opioid.
English: Slovak Republic
Maltese: Ir-Repubblika Slovakka, 12
English: 2.6 Arbitration, Community referrals and ‘opinions on any scientific matter' Substantial increase in arbitration and referral activity in 2006
Maltese: 2.6 Arbitraġġ, referenzi Komunitarji u ‘opinjonijiet dwar kwalunkwe materja xjentifika'
English: These monographs were released for public consultation prior to being finalised.
Maltese: Dawn il-monografiji inħarġu għal konsultazzjoni pubblika qabel ma ġew finalizzati.