FrancophonIA/ELRC3.0 huggingface dataset:
English: However, no further important differences exist for the haemodialysis indication in the national SmPCs approved in the EU MSs.
Maltese: Madankollu, ma jeżistux aktar differenzi importanti għall-indikazzjoni tal-emodijaliżi fl-SmPCs nazzjonali approvati fl-SM tal-UE.
English: • in patients with severe renal impairment (creatinine clearance 15-30 mL/min), since exposure of enoxaparin sodium is significantly increased, a dosage adjustment is recommended for therapeutic and prophylactic dosage ranges;
Maltese: • f'pazjenti b'indeboliment renali gravi (klirjanza tal-krejatinina 15-30 mL/min), billi l-esponiment għas-sodju tal-enossaparin żdied b'mod sinifikanti, huwa rrakkomandat aġġustament taddożaġġ għal meded ta' dożaġġ terapewtiku u profilattiku;
English: • Hypersensitivity to enoxaparin sodium, heparin or its derivatives, including other low molecular weight heparins (LMWH) or to any of the excipients;
Maltese: • L-ipersensitività għas-sodju tal-enossaparin, l-eparina jew id-derivattivi tagħha, inklużi eparini oħra b'piż molekulari baxx (LMWH) jew għal kwalunkwe wieħed mill-eċċipjenti;
English: The harmonised indication therefore states prophylaxis of venous thromboembolic disease in moderate and high risk surgical patients, in particular those undergoing orthopaedic or general surgery including cancer surgery.
Maltese: Għalhekk l-indikazzjoni armonizzata tiddikjara lprofilassi tal-marda tromboembolika venuża f'pazjenti kirurġiċi b'riskju moderat u għoli, b'mod partikolari dawk li jagħmlu kirurġija ortopedika jew ġenerali inkluż kirurġija tal-kanċer.
English: In general, the sub-sections on posology and method of administration were aligned with the harmonised indications for enoxaparin.
Maltese: B'mod ġenerali, is-sottotaqsimiet dwar il-pożoloġija u l-metodu ta' amministrazzjoni kienu allinjati malindikazzjonijiet armonizzati għall-enossaparin.
English: • History of immune mediated heparin-induced thrombocytopenia (HIT) within the past 100 days or in the presence of circulating antibodies (see also section 4.4 );
Maltese: • Storja ta' tromboċitopenja medjata mis-sistema immunitarja kkawżata mill-eparina (HIT) flaħħar 100 jum jew fil-preżenza ta' antikorpi li jiċċirkolaw (ara wkoll it-Taqsima 4.4);
English: The terminology used for the indication prophylaxis of venous thromboembolism in medical patients varied across Member States.
Maltese: It-terminoloġija użata għall-indikazzjoni tal-profilassi tat-tromboemboliżmu venuż fil-pazjenti mediċi varjat minn Stat Membru għal ieħor.
English: • spinal or epidural anaesthesia or loco-regional anaesthesia when enoxaparin sodium is used for treatment in the previous 24 hours (with a reference to section 4.4);
Maltese: • anesteżija spinali jew epidurali jew anesteżija lokoreġjonali meta s-sodju tal-enossaparin jintuża għat-trattament fl-24 siegħa preċedenti (b'referenza għat-Taqsima 4.4);
English: Other populations
Maltese: Popolazzjonijiet oħra
English: For treatment of acute ST-segment elevation myocardial infarction, the CHMP noted that the pivotal study (ExTRACT-TIMI 25) was carried out in STEMI patients fulfilling the following criteria:
Maltese: Għat-trattament tal-infart mijokardjali akut b'elevazzjoni tas-segment ST, is-CHMP innota li l-istudju ewlieni (ExTRACT-TIMI 25) twettaq fuq pazjenti STEMI li ssodisfaw il-kriterji li ġejjin:
English: Taking into account the risk of medication errors and the clarification as regards indications and contraindications, the CHMP agreed the following key messages to be used in a direct healthcare professional communication (DHPC) to general practitioners, orthopaedics, internists, cardiologists, haematologists, surgeons, pharmacists, nurses (or other as per national health care system):
Maltese: Filwaqt li jitqies ir-riskju ta' żbalji fil-medikazzjoni u l-kjarifika fir-rigward tal-indikazzjonijiet u lkontraindikazzjonijiet, is-CHMP qabel dwar il-messaġġi ewlenin li ġejjin li għandhom jintużaw f'komunikazzjoni diretta mal-fornitur tal-kura tas-saħħa (DHPC) ma' tobba tal-familja, ortopedisti, internisti, kardjologi, ematoloġisti, kirurgi, spiżjara, infermiera (jew oħrajn skont is-sistema tal-kura tas-saħħa nazzjonali):
English: o either as a once daily injection of 150 IU/kg (1.5 mg/kg): used in uncomplicated patients with low risk of VTE recurrence,
Maltese: IU/kg (1.5 mg/kg): użat f'pazjenti mingħajr kumplikazzjonijiet b'riskju baxx ta' rikorrenza tal-VTE,
English: A consistent wording has been approved on platelet count monitoring to take into account current international guidelines, in order to avoid unnecessary monitoring in patients at low risk of HIT. Other changes were made to complement the information already present in other parts of the product information:
Maltese: Test konsistenti ġie approvat dwar il-monitoraġġ tan-numru ta' pjastrini sabiex jitqiesu l-linji gwida internazzjonali attwali, sabiex jiġi evitat monitoraġġ mhux neċessarju fil-pazjenti b'riskju baxx ta' HIT.
English: This anticoagulant is used in the treatment and prophylaxis of thromboembolic disorders.
Maltese: Dan l-antikoagulant jintuża fit-trattament u l-profilassi ta' mard tromboemboliku.
English: The wording for the indication in this population therefore includes now disease in medical patients with an acute illness (such as acute heart failure, respiratory insufficiency, severe infections or rheumatic diseases) and reduced mobility at increased risk of venous thromboembolism.
Maltese: Għaldaqstant it-test għallindikazzjoni f'din il-popolazzjoni issa jinkludi mard f'pazjenti mediċi b'marda akuta (bħal insuffiċjenza akuta tal-qalb, insuffiċenzja respiratorja, infezzjonijiet gravi jew mard rewmatiku) u mobilità mnaqqsa b'riskju miżjud ta' tromboemboliżmu venuż.
English: For example, for pre-filled syringes of 0.4 ml, the strength will appear as: <Local tradename> 4,000 IU (40 mg)/0.4 ml solution for injection.
Maltese: <Isem kummerċjali lokali> 4 000 IU (40 mg)/0.4
English: Lovenox and associated names is authorised in all EU member states (MSs) as well as in Iceland and Norway.
Maltese: Lovenox u l-ismijiet assoċjati huwa awtorizzat fl-Istati Membri kollha tal-UE (SM) kif ukoll fl-Iżlanda u n-Norveġja.
English: • reduction of dosage in patients above 75 years old treated by enoxaparin for ST-segment elevation myocardial infarction (STEMI);
Maltese: • tnaqqis tad-dożaġġ fil-pazjenti ta' aktar minn 75 sena trattati bl-enossaparin għal infart mijokardjali b'elevazzjoni tas-segment ST (STEMI);
English: Revisions were made to this section to add the risk of acute infectious endocarditis.
Maltese: Saru reviżjonijiet għal din it-taqsima sabiex jiżdied ir-riskju ta' endokardite infettiva akuta.
English: • discontinue treatment in case of skin necrosis and cutaneous vasculitis.
Maltese: • jitwaqqaf it-trattament fil-każ ta' nekrożi tal-ġilda u vaskulite tal-ġilda.
English: • A contraindication in patients with severe renal impairment (creatinine clearance < 30 ml/min) that existed in some EU member states was removed from the Product Information, however, use in patients with end stage kidney disease (creatinine clearance <15 ml/min) is not recommended outside the prevention of thrombus formation in dialysis patients.
Maltese: • Kontraindikazzjoni fil-pazjenti b'indeboliment renali gravi (klirjanza tal-krejatinina < 30 ml/min) li eżistiet f'ċerti Stati Membri tal-UE tneħħiet mill-Informazzjoni dwar il-Prodott, madankollu, l-użu f'pazjenti b'mard renali fl-aħħar stadju (klirjanza tal-krejatinia <15 ml/min) mhuwiex rakkomandat lil hinn mill-prevenzjoni tal-iffurmar tat-trombus fil-pazjenti fuq dijaliżi.
English: Lovenox and associated names solution for injection is currently approved in more than 140 countries worldwide including all the European Union (EU) member states as well as Norway and Iceland.
Maltese: Issoluzzjoni għall-injezzjoni Lovenox u ismijiet assoċjati hija attwalment approvata f'aktar minn 140 pajjiż madwar id-dinja inklużi l-Istati Membri kollha tal-Unjoni Ewropea (UE) kif ukoll in-Norveġja u l-Iżlanda.
English: Some Member States had a contra-indication for severe renal impairment (clearance < 30 mL/min) in the therapeutic indications, which has been removed as part of the referral based on available data supporting use in this population.
Maltese: Ċerti Stati Membri kellhom kontraindikazzjoni għal indeboliment renali gravi (klirjanza < 30 mL/min) fl-indikazzjonijiet terapewtiċi, li tneħħew bħala parti mir-riferiment fuq il-bażi tad-data disponibbli li tappoġġja l-użu f'din il-popolazzjoni.
English: Further sub-sections were added to provide information on switch between enoxaparin sodium and oral anticoagulants as well as recommendations for administration in spinal/epidural anaesthesia or lumbar puncture.
Maltese: Aktar sottotaqsimiet ġew miżjuda sabiex tiġi pprovduta informazzjoni dwar il-bidla bejn is-sodju talenossaparin u l-antikoagulanti orali kif ukoll rakkomandazzjonijiet għall-amministrazzjoni tal-anesteżija fis-sinsla/epidurali jew titqib lumbari.
English: In view of this indication, the CHMP noted the consensus document of the Joint ESC/American College of Cardiology Committee for the redefinition of myocardial infarction (MI), which led to the revision of the definition of acute coronary syndromes (ACS) to UA and NSTEMI.
Maltese: Minħabba din l-indikazzjoni, is-CHMP indika d-dokument ta' kunsens tal-Kumitat Konġunt tal-ESC/lAmerican College of Cardiology għad-definizzjoni mill-ġdid tal-infart mijokardjali (MI), li wasslet għarreviżjoni tad-definizzjoni tas-sindromi koronarji akuti (ACS) għall-UA u l-NSTEMI.
English: Dosing in prophylaxis of venous thromboembolism in medical patients was harmonised to be aligned with ACCP guidelines.
Maltese: Id-dożaġġ fil-profilassi tat-tromboemboliżmu venuż fil-pazjenti mediċi ġie armonizzat biex ikun allinjat mal-linji gwida tal-ACCP.
English: • the Committee reviewed the totality of the data submitted by the MAH in support of the proposed harmonisation of the product information,
Maltese: • il-Kumitat irreveda t-totalità tad-data ppreżentata mill-MAH b'appoġġ għall-armonizzazzjoni proposta tal-informazzjoni dwar il-prodott,
English: The CHMP agreed to use this definition in the enoxaparin labelling, and the indication was harmonised to include treatment of unstable angina and NSTEMI administered concurrently with oral acetylsalicylic acid.
Maltese: Is-CHMP qabel li juża din id-definizzjoni fit-tikkettar tal-enossaparin, u l-indikazzjoni ġiet armonizzata biex tinkludi ttrattament tal-anġina instabbli u l-NSTEMI amministrat flimkien mal-aċidu aċetisaliċiliku orali.
English: For this indication in moderate and high risk surgical patients the CHMP considered that the SmPC should reflect that individual thromboembolic risk for patients can be estimated using a validated risk stratification model.
Maltese: Għal din l-indikazzjoni f'pazjenti kirurġiċi b'riskju moderat u għoli, is-CHMP ikkunsidra li l-SmPC għandu jirrifletti li r-riskju tromboemboliku individwali għall-pazjenti jista' jiġi stmat permezz ta' mudell validat ta' stratifikazzjoni tar-riskju.
English: The CHMP referred also for this indication to the existing ACCP guidelines, and further preferred a wording more in line with the current recommendations for thromboprophylaxis in acutely ill medical patients in the literature.
Maltese: Is-CHMP irrefera wkoll għall-indikazzjoni għal-linji gwida tal-ACCP eżistenti, u barra minn hekk ipprefera test li huwa aktar f'konformità mar-rakkomandazzjonijiet attwali għat-tromboprofilassi f'pazjenti mediċi b'mard akut fil-letteratura.
English: Unstable angina and NSTEMI indications
Maltese: Indikazzjonijiet għall-anġina instabbli u l-NSTEMI
English: Enoxaparin sodium is a low molecular weight heparin marketed under the trade names Lovenox and associated names.
Maltese: Is-sodju tal-enossaparin huwa eparina b'piż molekulari baxx kummerċjalizzat taħt l-ismijiet kummerċjali Lovenox u ismijiet assoċjati.
English: • The presentation 10,000 IU (100 mg)/10 mL solution for injection is used only for extracorporeal dialysis, and hence only this indication is covered in section 4.1,
Maltese: • Il-preżentazzjoni bħala soluzzjoni għall-injezzjoni 10 000 IU (100 mg)/10 mL tintuża biss għal dijaliżi barra mill-ġisem, u għalhekk din l-indikazzjoni biss hija koperta fit-Taqsima 4.1,
English: • the scope of the referral was the harmonisation of the product information,
Maltese: • il-kamp ta' applikazzjoni tar-riferiment kien l-armonizzazzjoni tal-informazzjoni dwar il-prodott,
English: In view of prevention of extracorporeal thrombus during haemodialysis, all Member States had this indication in the PI, except the Netherlands who did not find the data using the dosing scheme proposed at the time of initial Marketing authorisation sufficient.
Maltese: Fid-dawl tal-prevenzjoni tat-trombus barra mill-ġisem waqt id-dijaliżi tad-demm, l-Istati membri kollha kellhom din l-indikazzjoni fil-PI, minbarra n-Netherlands li ma sabitx id-data bl-użu tal-iskema ta' dożaġġ proposta fiż-żmien tal-awtorizzazzjoni inizjali għat-tqegħid fis-suq suffiċjenti.
English: As harmonisation of expression of strength to one of the options would have led to changes to the established practice in several countries, and as this may increase the risk of medication errors leading to higher risk of thrombosis or major bleeding, the wording has been amended to express the strength in both units (in IU anti-Xa/mL and its equivalence in mg/ml) on the outer-carton and immediate packaging (syringe) and in sections 1, 2 and 4.2.
Maltese: Billi l-armonizzazzjoni tal-espressjoni tas-saħħa ma' waħda mill-għażliet kienet twassal għal bidliet fil-prattika stabbilita f'diversi pajjiżi, u billi dan jista' jżid ir-riskju tal-iżbalji fil-medikazzjoni li jwasslu għal riskju ogħla ta' trombożi jew emorraġija maġġuri, it-test ġie emendat biex tiġi espressa s-saħħa fiż-żewġ unitajiet (f'IU anti Xa/mL u l-ekwivalenza tagħha f'mg/ml) fuq il-kaxxa ta' barra u l-ippakkjar primarju (is-siringa) u fitTaqsimiet 1, 2 u 4.2
English: Due to the divergent national decisions taken by Member States (MSs) concerning the authorisation of the above-mentioned product and its associated names, France notified the CHMP/European Medicines Agency of a referral under Article 30 of Directive 2001/83/EC for the above-mentioned product, in order to resolve divergences amongst the nationally authorised product information (PI) and thus to harmonise its divergent PIs across the EU.
Maltese: Minħabba d-deċiżjonijiet nazzjonali diverġenti meħudin mill-Istati Membri (SM) fir-rigward talawtorizzazzjoni tal-prodott imsemmi hawn fuq u l-ismijiet assoċjati tiegħu, Franza nnotifikat lisCHMP/l-Aġenzija Ewropea għall-Mediċini dwar riferiment skont l-Artikolu 30 tad-Direttiva 2001/83/KE għall-prodott imsemmi hawn fuq, sabiex jiġu riżolti diverġenzi fost l-informazzjoni dwar il-prodott (PI) awtorizzata fuq livell nazzjonali u b'hekk jiġu armonizzati l-PIs diverġenti tiegħu madwar l-UE kollha.
English: The SmPC was aligned to state the recommended dose as accepted in most countries of 1mg/kg, which is in line with the clinical data and with the recommendations from treatment guidelines.
Maltese: L-SmPC kien allinjat sabiex jiddikjara d-doża rrakkomandata ta' 1 mg/kg, kif aċċettata fil-maġġoranza tal-pajjiżi, u li hija f'konformità mad-data klinika u mar-rakkomandazzjonijiet mil-linji gwida għat-trattament.
English: For prophylaxis of venous thromboembolism (VTE) in surgical patients, the CHMP considered that it would be relevant to label the indication on the patient's level of thrombotic risk in line with the American College of Clinical Pharmacy (ACCP) Guidelines.
Maltese: Għall-profilassi tat-tromboemboliżmu venuż (VTE) fil-pazjenti kirurġiċi, is-CHMP iqis li jkun rilevanti li tiġi tikkettjata l-indikazzjoni dwar il-livell ta' riskju trombotiku tal-pazjent f'konformità mal-Linji
English: The CHMP also considered that the regimen should be selected by the physician based on an individual assessment including evaluation of the thromboembolic risk and of the risk of bleeding.
Maltese: L-iskema għandha tintgħażel mit-tabib skont l-eżaminazzjoni individwali inkluża l-evalwazzjoni tar-riskju tromboemboliku u r-riskju ta' emorraġija.
English: EMA/422021/2014 EMEA/H/C/001085
Maltese: EMEA/H/C/001085
English: It is available as tablets (2.5, 5, 7.5, 10, 15 and 20 mg).
Maltese: Jiġi bħala pilloli (2.5, 5, 7.5, 10, 15 u 20 mg).
English: The full EPAR for Olanzapine Glenmark can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Olanzapine Glenmark EMA/422021/2014
Maltese: EMA/422021/2014
English: Olanzapine Glenmark is a ‘generic medicine'.
Maltese: Olanzapine Glenmark huwa ‘mediċina ġenerika'.
English: Olanzapine Glenmark olanzapine
Maltese: Olanzapine Glenmark olanzapina
English: The active substance in Olanzapine Glenmark, olanzapine, is an antipsychotic medicine.
Maltese: Is-sustanza attiva f'Olanzapine Glenmark, l-olanzapina, hija mediċina antipsikotika.
English: The recommended starting dose of Olanzapine Glenmark depends on the disease being treated: 10 mg per day is used in schizophrenia and in the prevention of manic episodes, and 15 mg per day in the treatment of manic episodes, unless it is used with other medicines, in which case the starting dose can be 10 mg per day.
Maltese: Doża ta' 10 mg kuljum tintuża għall-iskiżofrenija u fil-prevenzjoni ta' episodji manijaċi, u 15 mg kuljum fil-kura ta' episodji manijaċi, sakemm ma tintużax ma' mediċini oħra, f'liema każ id-doża inizjali tista' tkun ta' 10 mg kuljum.
English: The European Commission granted a marketing authorisation valid throughout the EU for Olanzapine Glenmark on 3 December 2009.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha għal Olanzapine Glenmark fit-3 ta' Diċembru 2009.
English: It is thought that olanzapine's beneficial effect is due to it blocking receptors for the neurotransmitters 5-hydroxytrypamine (also called serotonin) and dopamine.
Maltese: Hu maħsub li l-effett benefiku tal-olanzapina huwa dovut għallimblokkar tar-riċetturi għan-newrotrażmettituri 5-idrossitriptamina ((5-hydroxytrypamine) imsejħa wkoll serotonina) u dopamina.
English: This is a summary of the European public assessment report (EPAR) for Olanzapine Glenmark.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Olanzapine Glenmark.
English: The CHMP concluded that, in accordance with EU requirements, Olanzapine Glenmark has been shown to have comparable quality and to be bioequivalent to Zyprexa.
Maltese: Is-CHMP ikkonkluda li, f'konformità mar-rekwiżiti tal-UE, Olanzapine Glenmark wera li għandu kwalità komparabbli u li huwa bijoekwivalenti għal Zyprexa.
English: Olanzapine Glenmark is a medicine containing the active substance olanzapine.
Maltese: Olanzapine Glenmark huwa mediċina li fiha s-sustanza attiva olanzapina.
English: Because Olanzapine Glenmark is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine Zyprexa.
Maltese: Peress li Olanzapine Glenmark huwa mediċina ġenerika, l-istudji fin-nies ġew limitati għal testitjiet biex jiddeterminaw il-bijoekwivalenza tiegħu mal-mediċina ta' referenza Zyprexa.
English: Olanzapine Glenmark is also used to treat moderate to severe manic episodes (extremely high mood) in adults.
Maltese: Olanzapine Glenmark jintuża wkoll fil-kura ta' episodji moderati sa severi tal-manija (burdata tajba b'mod estrem) f'adulti.
English: This means that Olanzapine Glenmark is similar to a ‘reference medicine' already authorised in the European Union (EU) called Zyprexa.
Maltese: Dan ifisser li Olanzapine Glenmark huwa simili għall‘mediċina ta' referenza' diġà awtorizzata fl-Unjoni Ewropea (UE) bl-isem ta' Zyprexa.
English: Therefore, the CHMP's view was that, as for Zyprexa, the benefit outweighs the identified risk.
Maltese: Għaldaqstant, il-fehma tas-CHMP kienet li, bħal f'Zyprexa, il-benefiċċji huma akbar mir-riskji identifikati.
English: Other information about Olanzapine Glenmark
Maltese: Informazzjoni oħra dwar Olanzapine Glenmark
English: Because Olanzapine Glenmark is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Maltese: Peress li Olanzapine Glenmark huwa mediċina ġenerika u huwa bijoekwivalenti għall-mediċina ta' referenza, il-benefiċċji u r-riskji tiegħu huma meqjusa li huma l-istess bħal dawk tal-mediċina ta' referenza.
English: Why has Olanzapine Glenmark been approved?
Maltese: Għaliex ġiet approvata Olanzapine Glenmark?
English: What is Olanzapine Glenmark?
Maltese: X'inhu Olanzapine Glenmark?
English: Since these neurotransmitters are involved in schizophrenia and in bipolar disorder, olanzapine helps to normalise the activity of the brain, reducing the symptoms of these diseases.
Maltese: Peress li dawn in-newrotrażmettituri huma involuti fl-iskiżofrenija u fiddisturbi bipolari, l-olanzapina tgħin fin-normalizzazzjoni tal-attività tal-moħħ, bit-tnaqqis tas-sintomi ta' dan il-mard.
English: Yes.
Maltese: Iva.
English: Are my personal data protected?
Maltese: Id-data personali tiegħi protetta?
English: • the description of the side effect;
Maltese: • deskrizzjoni tal-effett sekondarju;
English: You can also check the publicly available European database (www.adrreports.eu) or contact your national medicines authority for further information.
Maltese: Tista' tiċċekkja wkoll id-database Ewropew (www.adrreports.eu) jew tikkuntattja lill-awtorità nazzjonali tal-mediċini tiegħek għal aktar informazzjoni.
English: Frequently asked questions
Maltese: Mistoqsijiet komuni
English: The symbol does not mean that your medicine is unsafe.
Maltese: Is-simbolu ma jfissirx li l-mediċina tiegħek mhix sigura.
English: • information on the person who has had the side effect (such as age and sex);
Maltese: • informazzjoni dwar il-persuna li kellha l-effett sekondarju (bħal l-età u s-sess);
English: Where can I find information on side effects that have already been reported with the medicine?
Maltese: Fejn nista' nsib informazzjoni dwar l-effetti sekondarji tal-mediċina li diġà ġew rapportati?
English: Your report, along with other reports on the medicine, will be reviewed by medicines safety experts to see if there is any new information (known as a 'safety signal').
Maltese: Ir-rapport tiegħek, flimkien ma' rapporti oħrajn dwar il-mediċina, jiġi rivedut minn esperti tas-sigurta tal-mediċini biex jaraw jekk hemmx xi informazzjoni ġdida (magħrufa bħala ‘sinjal tas-sigurta').
English: • the batch number of the medicine (found on the packaging);
Maltese: • in-numru tal-lott tal-mediċina (li jinsab fuq l-imballaġġ);
English: All personal information related to the reporting of a side effect is processed in accordance with EU data protection legislation.
Maltese: L-informazzjoni personali kollha relatata marrapportar ta' effett sekondarju tiġi pproċessata skont il-leġiżlazzjoni tal-UE dwar il-protezzjoni tad-data.
English: Did you know?
Maltese: Kont taf?
English: If possible, you should provide the following information when making your report:
Maltese: Jekk ikun possibbli, għandek tipprovdi l-informazzjoni li ġejja meta tagħmel ir-rapport:
English: The medicine has a black triangle symbol in its package leaflet.
Maltese: Il-mediċina għandha simbolu ta' trijangolu iswed fil-fuljett tat-tagħrif.
English: How do I report a side effect?
Maltese: Kif nirrapporta effett sekondarju?
English: What information should I report?
Maltese: Liema informazzjoni għandi nirrapporta?
English: You can report side effects yourself
Maltese: Tista' tirrapporta l-effetti sekondarji inti stess
English: • the dose and the name of the medicine suspected to have caused the side effect (brand name as well as active ingredient);
Maltese: • kull mediċina oħra li tkun qed tittieħed fl-istess żmien (inklużi mediċini bla riċetta, rimedji mill-ħxejjex u kontraċettivi);
English: We are always learning more about medicines.
Maltese: Qed nitgħallmu dejjem aktar dwar il-mediċini.