FrancophonIA/ELRC3.0 huggingface dataset:
English: Your doctor may also check your kidney function; anticonvulsant agents (e.g. carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone); St. John's wort; nitroglycerin and other nitrates, or other substances called “vasodilators”; medicines used for HIV/AIDS (e.g. ritonavir, indinavir, nelfinavir); medicines used to treat fungal infections (e.g. ketoconazole, itraconazole);
Maltese: John's wort; - nitroglycerin u nitrati oħra, jew sustanzi oħra magħrufin bħala “vażodilaturi”; - mediċini li jintużaw għall-HIV/AIDS (eż. ritonavir, indinavir, nelfinavir); - mediċini li jintużaw għall-kura ta' infezzjonijiet tal-moffa (eż ketoconazole, itraconazole); - mediċini li jintużaw għall-kura ta' infezzjonijiet batterjali (bħal rifampicin, erythromycin,
English: What Imprida looks like and contents of the pack Imprida 5 mg/80 mg tablets are round and dark yellow with “NVR” on one side and “NV” on the other side.
Maltese: Kif jidher Imprida u l-kontenut tal-pakkett Imprida 5 mg/80 mg pilloli huma tondi u sofor skuri b' “NVR” fuq naħa u “NV” fuq in-naħa l-oħra.
English: - Severe skin reactions including intense skin rash, hives, reddening of the skin over your whole body, severe itching, blistering, peeling and swelling of the skin, inflammation of the mucous membranes (Stevens-Johnson Syndrome) or other allergic reactions.
Maltese: - Reazzjonijiet severi tal-ġilda fosthom raxx qawwi fil-ġilda, ħorriqija, ħmura fil-ġilda fuq ġismek kollu, ħakk qawwi, infafet, tqaxxir u nefħa fil-ġilda, infjammazzjoni tal-membrani mukużi (Sindrome ta' Stevens Johnson) jew reazzjonijiet allerġiċi oħra.
English: diuretics (a type of medicine also called “water tablets” which increases the amount of urine lithium (a medicine used to treat some types of depression); potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium and other substances that may increase potassium levels; certain types of painkillers called non-steroidal anti-inflammatory medicines (NSAIDs) or selective cyclooxygenase-2 inhibitors (COX-2 inhibitors).
Maltese: - lithium (mediċina li tintuża biex tikkura d-dipressjoni); - dijuretiċi li jfaddlu potassium, supplimenti ta' potassium, melħ ta' l-ikel għal min ibati bilpressjoni li jkun fih potassium u sustanzi oħra li jistgħu iżidu l-livelli ta' potassium; - ċertu tipi ta' mediċini kontra l-uġigħ msejħa mediċini anti-infjammatorji mhux sterojdi (NSAID's) jew inibituri selettivi ta' cyclooxygenase-2 (inibituri ta' COX-2).
English: Uncommon Uncommon Uncommon Uncommon Uncommon Uncommon Very rare Very rare
Maltese: Mhux komuni Mhux komuni Rari ħafna Rari ħafna
English: * mostly consistent with cholestasis
Maltese: * konsistenti l-aktar ma' kolestasi
English: What Imprida looks like and contents of the pack Imprida 5 mg/160 mg tablets are oval and dark yellow “NVR” on one side and “ECE” on the other side.
Maltese: Kif jidher Imprida u l-kontenut tal-pakkett Imprida 5 mg/160 mg pilloli huma ovali u sofor skuri b' “NVR” fuq naħa u “ECE” fuq in-naħa l-oħra.
English: Imprida 5 mg/80 mg film-coated tablets
Maltese: Imprida 5 mg/80 mg pilloli miksija b'rita
English: Uncommon Common Uncommon
Maltese: Mhux komuni Rari ħafna
English: Excessive hypotension was seen in 0.4% of patients with uncomplicated hypertension treated with Imprida in placebo-controlled studies.
Maltese: Pressjoni baxxa eċċessiva dehret f'0.4% tal-pazjenti b'pressjoni għolja mingħajr kumplikazzjonijiet li kienet kurata b'Imprida fi studji kontrollati bi plaċebo.
English: What Imprida looks like and contents of the pack Imprida 10 mg/160 mg tablets are oval and light yellow with “NVR” on one side and “UIC” on the other side.
Maltese: Kif jidher Imprida u l-kontenut tal-pakkett Imprida 10 mg/160 mg pilloli huma ovali u sofor ċari b' “NVR” fuq naħa u “UIC” fuq in-naħa l-oħra.
English: EU/1/06/373/034 280 film-coated tablets (4x70) EU/1/06/373/037 280 film-coated tablets (20x14)
Maltese: EU/1/06/373/037 280 pillola miksija b'rita (20x14)
English: EU/1/06/373/009 EU/1/06/373/010 EU/1/06/373/011 EU/1/06/373/012 EU/1/06/373/013 EU/1/06/373/014 EU/1/06/373/015 EU/1/06/373/016 EU/1/06/373/028 EU/1/06/373/029 EU/1/06/373/030 EU/1/06/373/035 EU/1/06/373/038
Maltese: EU/1/06/373/009 EU/1/06/373/010 EU/1/06/373/011 EU/1/06/373/012 EU/1/06/373/013 EU/1/06/373/014
English: EU/1/06/373/009 7 film-coated tablets EU/1/06/373/010 14 film-coated tablets EU/1/06/373/011 28 film-coated tablets EU/1/06/373/012 30 film-coated tablets EU/1/06/373/013 56 film-coated tablets EU/1/06/373/014 90 film-coated tablets EU/1/06/373/015 98 film-coated tablets EU/1/06/373/016 280 film-coated tablets EU/1/06/373/028 56x1 film-coated tablet (unit dose) EU/1/06/373/029 98x1 film-coated tablet (unit dose) EU/1/06/373/030 280x1 film-coated tablet (unit dose)
Maltese: EU/1/06/373/009 7 pilloli miksija b'rita EU/1/06/373/010 14-il pillola miksija b'rita EU/1/06/373/011 28 pillola miksija b'rita EU/1/06/373/012 30 pillola miksija b'rita EU/1/06/373/013 56 pillola miksija b'rita EU/1/06/373/014 90 pillola miksija b'rita EU/1/06/373/015 98 pillola miksija b'rita EU/1/06/373/016 280 pillola miksija b'rita EU/1/06/373/028 56xpillola 1 miksija b'rita (doża waħda)
English: This applies especially to the medicines listed below:
Maltese: Kellem lit-tabib tiegħek qabel tieħu Imprida:
English: EU/1/06/373/036 280 film-coated tablets (4x70) EU/1/06/373/039 280 film-coated tablets (20x14)
Maltese: EU/1/06/373/039 280 pillola miksija b'rita (20x14)
English: EU/1/06/373/017 7 film-coated tablets EU/1/06/373/018 14 film-coated tablets EU/1/06/373/019 28 film-coated tablets EU/1/06/373/020 30 film-coated tablets EU/1/06/373/021 56 film-coated tablets EU/1/06/373/022 90 film-coated tablets EU/1/06/373/023 98 film-coated tablets EU/1/06/373/024 280 film-coated tablets EU/1/06/373/031 56x1 film-coated tablet (unit dose) EU/1/06/373/032 98x1 film-coated tablet (unit dose) EU/1/06/373/033 280x1 film-coated tablet (unit dose)
Maltese: EU/1/06/373/017 7 pilloli miksija b'rita EU/1/06/373/018 14-il pillola miksija b'rita EU/1/06/373/019 28 pillola miksija b'rita EU/1/06/373/020 30 pillola miksija b'rita EU/1/06/373/021 56 pillola miksija b'rita EU/1/06/373/022 90 pillola miksija b'rita EU/1/06/373/023 98 pillola miksija b'rita EU/1/06/373/024 280 pillola miksija b'rita EU/1/06/373/031 56xpillola 1 miksija b'rita (doża b'waħda) EU/1/06/373/032 98xpillola 1 miksija b'rita (doża b'waħda) EU/1/06/373/033 280xpillola 1 miksija b'rita (doża b'waħda)
English: Hyperhidrosis
Maltese: Iperkalċimija
English: Dysgeusia
Maltese: Anoressija
English: EU/1/06/373/035 280 film-coated tablets (4x70) EU/1/06/373/038 280 film-coated tablets (20x14)
Maltese: EU/1/06/373/038 280 pillola miksija b'rita (20x14)
English: Dermatitis bullous
Maltese: Dermatite bl-imsiemer
English: EU/1/06/373/001 7 film-coated tablets EU/1/06/373/002 14 film-coated tablets EU/1/06/373/003 28 film-coated tablets EU/1/06/373/004 30 film-coated tablets EU/1/06/373/005 56 film-coated tablets EU/1/06/373/006 90 film-coated tablets EU/1/06/373/007 98 film-coated tablets EU/1/06/373/008 280 film-coated tablets EU/1/06/373/025 56x1 film-coated tablet (unit dose) EU/1/06/373/026 98x1 film-coated tablet (unit dose) EU/1/06/373/027 280x1 film-coated tablet (unit dose)
Maltese: EU/1/06/373/001 7 pilloli miksija b'rita EU/1/06/373/002 14-il pillola miksija b'rita EU/1/06/373/003 28 pillola miksija b'rita EU/1/06/373/004 30 pillola miksija b'rita EU/1/06/373/005 56 pillola miksija b'rita EU/1/06/373/006 90 pillola miksija b'rita EU/1/06/373/007 98 pillola miksija b'rita EU/1/06/373/008 280 pillola miksija b'rita EU/1/06/373/025 56xpillola 1 miksija b'rita (doża waħda)
English: Reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with angiotensin converting enzyme inhibitors or angiotensin II receptor antagonists, including valsartan.
Maltese: Żiediet riversibbli tal-konċentrazzjonijiet ta' lithium fis-serum u tossiċità kienu rappurtati waqt li lithium kien qiegħed jingħata flimkien mal-inibituri tal-enzima li tibdel angiotensin jew antagonisti tar-riċettur ta' anġjotensin II, inkluż valsartan.
English: Imprida 5 mg/80 mg may be administered in patients whose blood pressure is not adequately controlled with amlodipine 5 mg or valsartan 80 mg alone.
Maltese: Imprida 5 mg/80 mg jista' jingħata lill-pazjenti li ma jkollhomx pressjoni kontrollata tajjeb b'amlodipine 5 mg jew valsartan 80 mg waħidhom.
English: Vomiting
Maltese: Vertigo
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Maltese: Informazzjoni dettaljata dwar din il-medicina tinsab fuq is-sit elettroniku tal-Agenzija Ewropea għallil-Medicini http://www.ema.europa.eu
English: Pitting oedema
Maltese: TAGĦRIF
English: Infants whose mothers have taken AIIRAs should be closely observed for hypotension (see sections 4.3 and 4.4).
Maltese: Trabi li ommhom ħadet AIIRAs għandhom jkunu taħt osservazzjoni mill-qrib għal pressjoni baxxa (ara ukoll sezzjonijiet 4.3 u 4.4).
English: When switching eligible hypertensive patients (see section 4.1) with hepatic impairment to amlodipine or Imprida, the lowest available dose of amlodipine monotherapy or of the amlodipine component, respectively, should be used.
Maltese: Meta pazjenti eliġibbli bi pressjoni għolja (ara sezzjoni 4.1) li għandhom indeboliment epatiku jinqalbu għal amlodipine jew Imprida, għandha tintuża l-inqas doża disponibbli ta' amlodipine bħala monoterapija jew tal-komponent ta' amlodipine, rispettivament.
English: Imprida 5 mg/160 mg film-coated tablets
Maltese: Imprida 5 mg/160 mg pilloli miksija b'rita
English: Imprida 10 mg/160 mg film-coated tablets
Maltese: Imprida 10 mg/160 mg pilloli miksija b'rita
English: This metabolite is pharmacologically inactive.
Maltese: Dan il-metabolu m'għandux attività farmakoloġika.
English: Interactions linked to amlodipine
Maltese: Amlodipine Komuni
English: Use in patients with hypertension
Maltese: PROPRJETAJIET FARMAKOLOĠIĊI
English: Dizziness
Maltese: Pollakijurja
English: Rash
Maltese: FOLJI
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-medicina tinsab fuq is-sit elettroniku tal-Agenzija Ewropea għallMedicini http://www.ema.europa.eu
English: Film-coated tablet
Maltese: Indeboliment fil-vista
English: Oedema peripheral
Maltese: KLASSIFIKAZZJONI ĠENERALI
English: Purpura
Maltese: Poliurja
English: • Hypersensitivity to the active substances, to dihydropyridine derivatives, or to any of the
Maltese: • Sensittività eċċessiva għas-sustanzi attivi, għad-derivati dihydropyridine, jew għal kwalunkwe wieћed mill-eċċipjenti elenkati fis-sezzjoni 6.1.
English: When switching eligible elderly hypertensive patients (see section 4.1) to amlodipine or Imprida, the lowest available dose of amlodipine monotherapy or of the amlodipine component, respectively, should be used.
Maltese: Meta pazjenti eliġibbli anzjani bi pressjoni għolja (ara sezzjoni 4.1) jinqalbu għal amlodipine jew Imprida, għandha tintuża linqas doża disponibbli ta' amlodipine bħala monoterapija jew tal-komponent ta' amlodipine, rispettivament.
English: For convenience, patients receiving valsartan and amlodipine from separate tablets/capsules may be switched to Imprida containing the same component doses.
Maltese: Għall-konvenjenza, pazjenti li qed jieħdu amlodipine u valsartan minn pilloli/kapsuli separati jistgħu jinqalbu għal Imprida li fihom l-istess dożi tal-komponenti.
English: Additional information on the combination
Maltese: Interazzjonijiet komuni għall-kombinazzjoni
English: Interactions common to the combination No drug-drug interaction studies have been performed with Imprida and other medicinal products.
Maltese: Ma twettaq l-ebda studju ta' interazzjoni ma' Imprida u prodotti mediċinali oħrajn.
English: Common Common Uncommon Common
Maltese: Mhux komuni Mhux komuni Rari
English: Oedema
Maltese: Treddigħ
English: The amlodipine component of Imprida inhibits the transmembrane entry of calcium ions into cardiac and vascular smooth muscle.
Maltese: Il-komponent amlodipine f'Imprida jinibixxi id-dħul mill-membrana ta' joni ta' calcium fil-muskoli tal-qalb u tal-muskoli lixxi tal-vini.
English: Imprida 5 mg/160 mg may be administered in patients whose blood pressure is not adequately controlled with amlodipine 5 mg or valsartan 160 mg alone.
Maltese: Imprida 5 mg/160 mg jista' jingħata lill-pazjenti li ma jkollhomx pressjoni kontrollata tajjeb b'amlodipine 5 mg jew valsartan 160 mg waħidhom.
English: Commonly used antihypertensive agents (e.g. alpha blockers, diuretics) and other medicinal products which may cause hypotensive adverse effects (e.g. tricyclic antidepressants, alpha blockers for treatment of benign prostate hyperplasia) may increase the antihypertensive effect of the combination.
Maltese: Sustanzi oħrajn li jbaxxu l-pressjoni li jintużaw ta' spiss eż imblokkaturi tar-riċetturi alpha dijuretiċi) u prodotti mediċinali oħrajn li jista' jkollhom effetti avversi li jbaxxu l-pressjoni (eż mediċini triċikliċi kontra d-depressjoni, imblokkaturi tar-riċetturi alpha għall-kura ta' iperplażja beninna talprostata) jistgħu jżidu l-effett kontra l-pressjoni għolja tal-kombinazzjoni.
English: 20 December 2013 EMA/14811/2014
Maltese: 20 ta' Diċembru 2013 EMA/14811/2014
English: − malignant arterial hypertension/hypertensive encephalopathy;
Maltese: − ipertensjoni arterjali malinna/enċefalopatija ipertensiva;
English: • treatment of post-operative hypertension.
Maltese: • kura ta' ipertensjoni wara operazzjoni.
English: In adults, treatment should start with a continuous administration of nicardipine at a rate of 3-5 mg/h.
Maltese: Fl-adulti, il-kura għandha tinbeda b'għoti kontinwu ta' nicardipine f'rata ta' 3-5 mg/h.
English: The CHMP opinion was sent to the European Commission, which endorsed it and adopted a final legally binding decision valid throughout the EU on 20 December 2013.
Maltese: L-opinjoni tas-CHMP intbagħtet lill-Kummissjoni Ewropea, li approvatha u adottat deċiżjoni finali legalment vinkolanti valida fl-UE kollha fl-20 ta' Diċembru 2013.
English: Medicines containing nicardipine given into a vein are authorised in the following EU Member States: Belgium, France, Luxemburg, the Netherlands and Spain.
Maltese: Mediċini li fihom nicardipine li jingħataw ġl-vina huma awtorizzati fl-Istati Membri tal-UE li ġejjin: ilBelġju, Franza, il-Lussemburgu, il-Pajjiżi l-Baxxi u Spanja.
English: The review of intravenous nicardipine was initiated in July 2012 at the request of the United Kingdom, under Article 31 of Directive 2001/83/EC.
Maltese: Ir-reviżjoni ta' nicardipine li jingħata ġol-vini inbdiet f'Lulju 2012 fuq talba tar-Renju Unit, skont lArtikolu 31 tad-Direttiva 2001/83/KE.
English: − severe pre-eclampsia, when other intravenous antihypertensive agents are not recommended or are contra-indicated;
Maltese: − pre-eklampsja severa, meta aġenti oħrajn antiipertensivi li jingħataw ġol-vina ma jkunux rakkomandati jew ikunu kontraindikati;
English: It works as a ‘calcium-channel blocker': this means that it blocks special channels on the surface of cells called calcium channels, through which calcium ions normally enter the cells.
Maltese: Jaħdem bħala ‘imblokkatur tal-kanal tal-kalċju': dan ifisser li jimblokka kanali speċifiċi fuq il-wiċċ taċ-ċelloli msejħa kanali tal-kalċju, li minnhom il-joni tal-kalċju normalment jidħlu fiċ-ċelloli.
English: − aortic dissection, when short acting beta-blocker therapy is not suitable, or in combination with a beta-blocker when beta-blockade alone is not effective;
Maltese: − dissezzjoni aortika, meta terapija b'imblokkatur beta li jaġixxi fuq żmien qasir ma tkunx adegwata, jew f'kombinazzjoni ma' imblokkatur beta meta imblokkatur beta waħdu ma jkunx effettiv;
English: On 24 October 2013, the European Medicines Agency completed a benefit-risk review of intravenous (given into a vein) nicardipine medicines.
Maltese: Fl-24 ta' Ottubru 2013, l-Aġenzija Ewropea għall-Mediċini temmet reviżjoni tal-benefiċċju-riskju ta' mediċini li fihom nicardipine li jingħataw ġol-vina.
English: Nicardipine was also used in some EU countries for controlled hypotension during anaesthesia, for controlling hypertension during surgery and for treating acute severe hypertension with left ventricular decompensation and pulmonary oedema.
Maltese: Nicardipine intuża wkoll f'xi pajjiżi tal-UE għal ipotensjoni kkontrollata waqt anestesija, għall-kontroll ta' ipertensjoni matul kirurġija u għall-kura ta' ipertensjoni severa akuta b'dikumpensazzjoni ventrikulari tax-xellug u edema pulmonari.
English: Nicardipine is an ‘antihypertensive' medicine that reduces blood pressure by allowing the blood vessels to relax.
Maltese: Nicardipine huwa mediċina ‘antiipertensiva' li tnaqqas il-pressjoni tad-demm billi tippermetti lill-vażi tad-demm jirrilassaw.
English: The review of intravenous nicardipine was triggered by the UK medicines regulatory agency (MHRA), following submission in the UK of an application for a generic intravenous nicardipine medicine.
Maltese: Ir-reviżjoni ta' nicardipine li jingħata ġol-vini nbdiet mill-aġenzija regolatorja tal-mediċini tar-Renju Unit (MHRA), wara li fir-Renju Unit kienet ippreżentata applikazzjoni għal mediċina ġenerika li fiha nicardipine għall-għoti ġol-vini.
English: The recommended therapeutic indications of intravenous nicardipine are now:
Maltese: L-indikazzjonijiet terapewtiċi rakkomandati ta' nicardipine li jingħata ġol-vini issa huma:
English: Having assessed the available evidence on the safety and effectiveness of intravenous nicardipine from published studies and post-marketing data, the CHMP concluded that an intravenous formulation of nicardipine is a useful treatment for high blood pressure in specific settings and with appropriate specialist intervention and monitoring.
Maltese: Wara li vvaluta l-evidenza disponibbli dwar is-sigurtà u l-effikaċja ta' nicardipine li jingħata ġol-vina minn studji ppubblikati u dejta wara t-tqegħid fis-suq, is-CHMP ikkonkluda li l-formulazzjoni ta' nicardipine li tingħata ġol-vini hija kura utli għall-pressjoni għolja tad-demm f'sitwazzjonijiet speċifiċi u b'intervent speċjalista u monitoraġġ xieraq.
English: Regarding the posology, nicardipine should be administered by continuous intravenous infusion.
Maltese: Fir-rigward tal-pożoloġija, nicardipine għandu jingħata permezz ta' infużjoni kontinwa ġol-vina.
English: • An EU-wide review of medicines containing nicardipine given into a vein has been carried out and recommendations have been given to ensure the safe and effective use of these medicines.
Maltese: • Saret reviżjoni fl-UE kollha tal-mediċini li fihom nicardipine li jingħataw ġol-vina u rrakkomandazzjonijiet ingħataw biex jiġi żgurat l-użu sigur u effikaċi ta' dawn il-mediċini.
English: The MHRA was concerned that the clinical data submitted were inadequate to determine the benefits and risks of the generic medicine in the proposed indications.
Maltese: L-MHRA kienet imħassba li d-dejta klinika ppreżentata ma kienitx adegwata biex tiddetermina l-benefiċċji u r-riskji tal-mediċina ġenerika fl-indikazzjonijiet proposti.
English: Nicardipine should be used with caution and at lower doses in specific patient populations, including patients with liver and kidney problems and children.
Maltese: Nicardipine għandu jintuża b'kawtela u f'dożi aktar baxxi f'popolazzjonijiet speċifiċi ta' pazjenti, inklużi pazjenti bi problemi fil-fwied u l-kliewi u fit-tfal.
English: The EU-wide review of intravenous nicardipine has resulted in updated prescribing information for these medicines.
Maltese: Ir-reviżjoni ta' nicardipine li jingħata ġol-vina li saret fl-UE kollha wasslet għal informazzjoni aġġornata dwar il-preskrizzjoni għal dawn il-mediċini.
English: • treatment of acute life-threatening hypertension, particularly in the event of:
Maltese: • kura ta' ipertensjoni akuta ta' periklu għall-ħajja, partikularment fil-każ ta':
English: Detailed information on the recommended uses of intravenous nicardipine, including instructions on how to use these medicines, can be found below.
Maltese: Informazzjoni dettaljata dwar l-użijiet rakkomandati ta' nicardipine ġol-vina, inklużi struzzjonijiet dwar kif tuża dawn il-mediċini, tista' tinsab hawn taħt.
English: • These medicines will be given to you in hospital as a drip into a vein, and your blood pressure will be regularly monitored.
Maltese: • Dawn il-mediċini se jingħatawlek ġo sptar bħala dripp ġol-vina, u l-pressjoni tad-demm tiegħek se tiġi mmonitorjata regolarment.
English: 13 September 2013 EMA/579491/2013
Maltese: 13 ta' Settembru 2013 EMA/579491/2013
English: The complexes involved in this procedure were ferric carboxymaltose, iron dextran, sodium ferric gluconate, iron isomaltoside and iron sucrose, which are authorised in all EU Member States via national procedures.
Maltese: Il kumplessi involuti f'din proċedura kienu ferric carboxymaltose, iron dextran, sodium ferric gluconate, iron isomaltoside u iron sucrose li huma awtorizzati fl-Istati Membri kollha tal-UE permezz ta' proċeduri nazzjonali.
English: • Data on the risk of hypersensitivity comes mainly from post-marketing spontaneous reports and the total number of life-threatening and fatal events reported is low.
Maltese: • Id-dejta dwar ir-riskju ta' sensittività eċċessiva fil-biċċa l-kbira tagħha toriġina mir-rapporti spontanji ta' wara t-tqegħid fis-suq filwaqt li n-numru totali ta' avvenimenti fatali li ġew irrapportati kien wieħed baxx.
English: • Intravenous iron-containing products are contraindicated in patients with hypersensitivity to the active substance or excipients.
Maltese: • Il-prodotti li fihom il-ħadid li jingħataw ġol-vina huma kontraindikati f'pazjenti b'sensittività eċċessiva għas-sustanza attiva jew l-eċċipjenti.
English: The review of intravenous iron-containing medicines was initiated at the request of France, under Article 31 of Directive 2001/83/EC.
Maltese: Ir-reviżjoni tal-mediċini li fihom il-ħadid li jingħataw ġol-vina nbdiet fuq talba ta' Franza, skont lArtikolu 31 tad-Direttiva 2001/83/KE.
English: The CHMP recommendation was sent to the European Commission, which on 13 September 2013 endorsed it and adopted a final decision that is legally binding throughout the EU.
Maltese: Ir-rakkomandazzjoni tas-CHMP intbagħtet lillKummissjoni Ewropea, li fit-13 ta' Settembru 2013 approvatha u adottat deċiżjoni finali li torbot legalment madwar l-UE kollha.
English: The CHMP opinion was forwarded to the European Commission, which on 13 September 2013 endorsed it and adopted a final decision that is legally binding throughout the EU.
Maltese: L-opinjoni tas-CHMP intbagħtet lill-Kummissjoni Ewropea, li fit-13 ta' Settembru 2013 approvata u adottat deċiżjoni finali li torbot legalment valida madwar l-UE kollha.
English: The review of intravenous iron medicines was triggered by the French medicines agency, the National Agency for the Safety of Medicine and Health Products (ANSM), following a national review in 2010.
Maltese: Ir-reviżjoni tal-mediċini tal-ħadid li jingħataw ġol-vina nbdiet mill-aġenzija Franċiża tal-mediċini, lAġenzija Nazzjonali għas-Sigurtà tal-Mediċini u l-Prodotti tas-Saħħa (ANSM), wara reviżjoni nazzjonali fl-2010.
English: The various iron preparations contain complexes of iron bound to other molecules such as sugar molecules.
Maltese: Id-diversi preparazzjonijiet tal-ħadid fihom kumplessi tal-ħadid imwaħħla ma' molekuli oħra bħal molekuli taz-zokkor.
English: On 27 June 2013 the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) completed its review of intravenous iron-containing medicines used to treat iron deficiency and anaemia (low red blood cell counts) associated with low iron levels.
Maltese: Fis-27 ta' Ġunju 2013, il-Kumitat għall-Prodotti Mediċini għall-Użu mill-Bniedem (CHMP) tal-Aġenzija Ewropea tal-Mediċini lesta r-reviżjoni tiegħu tal-mediċini li fihom il-ħadid li jingħataw ġol-vina użati biex jiġu kkurati d-defiċjenza ta' ħadid u anemija (numru baxx ta' ċelloli tad-demm ħomor) assoċjati ma' livelli baxxi ta' ħadid.