FrancophonIA/ELRC3.0 huggingface dataset:
English: Co-administration of an aluminium hydroxide/magnesium carbonate antacid or proton pump inhibitor (pantoprazole) did not affect vorapaxar AUC with only small decreases in Cmax.
Maltese: L-għoti flimkien ma' antaċidu li fih aluminium hydroxide/magnesium carbonate jew impeditur tal-pompa tal-proton (pantoprazole) m'affetwax l-AUC ta' vorapaxar b'żidiet żgħar biss fisCmax.
English: BLISTER - unit dose
Maltese: Informazzjoni għall-pazjent
English: Zontivity prevents platelets from sticking together.
Maltese: Għandha tiġi evitata interruzzjoni fil-kura b'Zontivity.
English: Each film-coated tablet contains 2.08 mg vorapaxar (as vorapaxar sulfate).
Maltese: Kull pillola miksija b'rita fiha 2.08 mg ta' vorapaxar (bħala vorapaxar sulfate).
English: Zontivity is not recommended for children and adolescents under 18 years of age.
Maltese: Zontivity mhuwiex irrakkomandat għal tfal u adolexxenti ta' taħt it-18-il sena.
English: System Organ Class
Maltese: KLASSIFIKAZZJONI ĠENERALI
English: What Zontivity looks like and contents of the pack Tablets are yellow, oval-shaped, film-coated tablets, size 8.48 mm x 4.76 mm, with “351” on one side and the MSD logo on the other side.
Maltese: Il-pilloli huma sofor, f'għamla ovali, miksijin b'rita, b'daqs ta' 8.48 mm x 4.76 mm, b'“351” fuq naħa waħda u l-logo ta' MSD fuq in-naħa l-oħra.
English: In humans, vorapaxar has been administered in single doses up to 120 mg and daily doses of 5 mg for up to 4 weeks without observation of dose-associated adverse events or identification of a specific risk.
Maltese: Fil-bniedem, vorapaxar ingħata f'dożi singoli sa 120 mg u dożi kuljum ta' 5 mg sa 4 ġimgħat mingħajr ma ġew osservati avvenimenti avversi assoċjati mad-doża jew identifikazzjoni ta' riskju speċifiku.
English: Acetylsalicylic acid, vorapaxar, and clopidogrel in combination produced significant prolongation of bleeding time.
Maltese: Acetylsalicylic acid, vorapaxar, u clopidogrel f'daqqa pproduċew dewmien sinifikanti filħin tal-fsada.
English: The film-coated tablets are yellow, oval-shaped, size 8.48 mm x 4.76 mm, with “351” on one side and the MSD logo on the other side.
Maltese: Il-pilloli miksijin b'rita huma sofor, f'għamla ovali, ta' daqs 8.48 mm x 4.76 mm, b'“351” fuq naħa waħda u l-logo ta' MSD fuq in-naħa l-oħra.
English: General risk of bleeding
Maltese: Riskju ġenerali ta' fsada
English: TIMI Major: Clinically apparent with >50 g/L decrease in haemoglobin or intracranial haemorrhage.
Maltese: Tidher b'mod kliniku bi tnaqqis ta' >50 g/L fl-emoglobina jew emorraġija ġol-kranju.
English: The study's primary endpoint was the composite of cardiovascular death, MI, stroke, and UCR.
Maltese: Il-punt finali primarju tal-istudju kien l-amalgamazzjoni ta' mewt kardjovaskulari, MI, puplesija, u UCR.
English: The findings for the key secondary efficacy endpoint, a 3-year K-M event rate of 9.3% in the Zontivity group compared with that of 10.5% in placebo group (HR: 0.87; 95% CI, 0.80 to 0.94; p <0.001).
Maltese: 5% fil-grupp ta' plaċebo (HR: 0.87; 95% CI, 0.80 sa 0.94; p <0.
English: There are no data on fertility in humans administered Zontivity.
Maltese: Ma hemm l-ebda dejta dwar il-fertilità fil-bnedmin li ngħataw Zontivity.
English: The systemic pharmacokinetics of vorapaxar are linear with accumulation (6-fold) predictable from single- to multiple-dose data.
Maltese: Ilfarmakokinetika sistemika ta' vorapaxar hija lineari b'akkumulazzjoni (6 drabi aktar) imbassra minn dejta b'doża waħda sa b'ħafna dożi.
English: • pink, red, or brown urine
Maltese: • awrina roża, ħamra jew kannella
English: Vorapaxar is also a substrate of CYP2J2; therefore, there is a potential for potent inhibitors of CYP2J2 to result in increases in vorapaxar exposure.
Maltese: Vorapaxar huwa wkoll sustrat ta' CYP2J2; għalhekk, hemm il-possibbiltà li impedituri qawwija ta' CYP2J2 iwasslu għal żidiet fl-esponiment għal vorapaxar.
English: • rifampin (used to treat tuberculosis and some other infections)
Maltese: • rifampin (jintuża biex jikkura t-tuberkulożi u xi infezzjonijiet oħra)
English: Hazard ratio is Zontivity group versus placebo group
Maltese: Jekk tinsa tieħu Zontivity
English: Zontivity and lactose
Maltese: Zontivity fih il-lactose.
English: Patients experiencing acute coronary syndrome (ACS) while on Zontivity can remain on Zontivity.
Maltese: Ilpazjenti li jkollhom sindrome koronarju akut (ACS - acute coronary syndrome) waqt li jkunu qed jieħdu Zontivity jistgħu jibqgħu jieħdu Zontivity.
English: Vorapaxar does not inhibit platelet aggregation induced by other agonists such as adenosine diphosphate (ADP), collagen or a thromboxane mimetic.
Maltese: Vorapaxar ma jinibixxix it-tagħqid tal-plejtlits ikkaġunat minn agonisti oħra bħal adenosine diphosphate (ADP), kollaġen jew waħda mis-sustanzi li timita thromboxane.
English: Effects of vorapaxar on other medicinal products
Maltese: Effetti ta' vorapaxar fuq prodotti mediċinali oħra
English: In addition, no clinically meaningful inhibition of OATP1B1, OATP1B3, BCRP, OAT1, OAT3, and
Maltese: Barra dan, ma hija antiċipata l-ebda inibizzjoni b'sinifikat kliniku ta' OATP1B1, OATP1B3, BCRP, OAT1, OAT3, u OCT2 permezz ta' vorapaxar jew M20.
English: Bleeding should be suspected in any patient who is hypotensive and has recently undergone coronary angiography, percutaneous coronary intervention (PCI), coronary artery bypass graft surgery (CABG), or other surgical procedures, even if the patient does not have any signs of bleeding.
Maltese: Għandha tiġi ssuspettata fsada fi kwalunkwe pazjent li għandu pressjoni baxxa u li dan l-aħħar kellu anġjografija koronarja, intervent perkutanju koronarju (PCI - percutaneous coronary intervention), kirurġija ta' bypass graft fl-arterja koronarja (CABG - coronary artery bypass graft), jew proċeduri kirurġiċi oħra, anke jekk il-pazjent m'għandu l-ebda sinjali ta' fsada.
English: The combination of vorapaxar with warfarin or other oral anticoagulants may increase the risk of bleeding and should be avoided.
Maltese: Ilkombinazzjoni ta' vorapaxar ma' warfarin jew antikoagulanti orali oħra, tista' żżid ir-riskju ta' fsada u għandu jiġi evitat.
English: The median Body Mass Index was 28.
Maltese: Il-medjan tal-Indiċi tal-Massa tal-Ġisem kien 28.
English: The adverse reactions of bleeding in Table 1 are summarized for the TRA 2°P TIMI 50 study.
Maltese: Ir-reazjonijiet avversi ta' fsada f'Tabella 1 huma miġbura fil-qosor għall-istudju TRA 2°P TIMI 50.
English: Magyarország MSD Pharma Hungary Kft. Tel.: +361 888 53 00 hungary_msd@merck.com
Maltese: +361 888 53 00 hungary_msd@merck.com
English: * Each patient was counted only once (first component event) in the component summary that contributed to the primary efficacy endpoint K-M estimate at 1,080 days Hazard ratio is Zontivity group versus placebo group Cox proportional hazard model with covariates treatment and stratification factors (qualifying atherosclerotic disease and planned thienopyridine use)
Maltese: * Kull pazjent ingħadd darba biss (l-ewwel komponent ta' avveniment) fis-sommarju ta' komponent li kkontribwixxa għall-punt finali primarju ta' effikaċja
English: Ingestion of vorapaxar with a high-fat meal resulted in no meaningful change in AUC with a small (21%) decrease in Cmax and delayed tmax (45 minutes).
Maltese: It-teħid ta' vorapaxar ma' ikla b'ammont kbir ta' xaħam ma wassal għall-ebda bidla ta' sinifikat flAUC bi tnaqqis żgħir (21%) fis-Cmax u dewmien fit-tmax (45 minuta).
English: Severe renal impairment
Maltese: Disturbi vaskulari
English: In addition, vorapaxar inhibits thrombin receptor agonist peptide (TRAP)-induced platelet aggregation without affecting coagulation parameters.
Maltese: Kliniċi fis-Sindrome Koronarju Akut -Thrombin Receptor Antagonist for Clinical Event Reduction in Acute Coronary
English: Pharmacotherapeutic group: Antithrombotic agents, platelet aggregation inhibitors excluding heparin, ATC code: B01AC26.
Maltese: Sustanzi antitrombotiċi, impedituri ta' tagħqid tal-plejtlits li ma jinkludux l-eparina, Kodiċi ATC:
English: The treatment effect of vorapaxar on the primary and key secondary endpoints was shown to be durable and persistent over the length of the TRA 2°P - TIMI 50 study.
Maltese: L-effett tal-kura ta' vorapaxar fuq il-punti finali primarji u sekondarji l-aktar importanti ntwera li dam iservi u kien persistenti matul il-perjodu ta' żmien tal-istudju TRA 2°P - TIMI 50.
English: Table 3: CABG-Related Bleeds
Maltese: Tabella 3: Fsada marbuta ma' CABG
English: Of the patients with PAD without a history of stroke or TIA, 61% were receiving acetylsalicylic acid without thienopyridine, 8% were receiving a thienopyridine without acetylsalicylic acid, and 27% were receiving both acetylsalicylic acid and a thienopyridine when they enrolled.
Maltese: Mill-pazjenti b'PAD mingħajr storja ta' puplesija jew TIA, 61% kienu qed jirċievu acetylsalicylic acid mingħajr thienopyridine, 8% kienu qed jirċievu wieħed mit-thienopyridines mingħajr acetylsalicylic acid, u 27% kienu qed jirċievu kemm acetylsalicylic acid kif ukoll wieħed mit-thienopyridines meta ddaħħlu fl-istudju.
English: After oral administration of a single vorapaxar sulfate 2.5 mg dose, vorapaxar is rapidly absorbed and peak concentrations occur at a median tmax of 1 hour (range: 1 to 2) under fasted conditions.
Maltese: Wara għoti mill-ħalq ta' doża waħda ta' 2.5 mg vorapaxar sulfate, vorapaxar jiġi assorbit malajr u logħla konċentrazzjonijiet iseħħu f'medjan ta' tmax ta' siegħa (medda: siegħa sa sagħtejn) f'kundizzjonijiet ta' sawm.
English: Fatal Bleeding
Maltese: Fsada Fatali
English: In TRA 2°P - TIMI 50, 367 post-MI or PAD patients with no history of stroke or TIA underwent CABG surgery.
Maltese: Fi TRA 2°P - TIMI 50, 367 pazjent wara
English: Vorapaxar was not mutagenic or genotoxic in a battery of in vitro and in vivo studies.
Maltese: Vorapaxar ma kellux effett mutaġeniku jew effett tossiku fuq il-ġeni f'sensiela ta' studji in vitro u in vivo.
English: • if you have ever had a stroke or ‘mini stroke' (also called a ‘transient ischemic attack' or TIA)
Maltese: • Pazjenti bi storja ta' puplesija jew attakk iskemiku temporanju (TIA - transient ischaemic
English: In general, a body weight <60 kg is a risk factor for bleeding.
Maltese: B'mod ġenerali, piż tal-ġisem ta' <60 kg huwa fattur ta' riskju għall-fsada.
English: No meaningful changes in P-selectin, sCD40L and hs-CRP concentrations were observed in patients treated with vorapaxar in the Phase 2/3 clinical trials.
Maltese: Ma kienu osservati l-ebda tibdiliet ta' importanza fil-konċentrazzjonijiet ta' P-selectin, sCD40L u hs-CRP f'pazjenti kkurati b'vorapaxar fil-provi kliniċi ta' Fażi 2/3.
English: In post-MI or PAD patients with no history of stroke or TIA, the 3 year K-M event rates for ICH were 0.6% and 0.5% for Zontivity plus standard care and standard care alone, respectively.
Maltese: K-M għal ICH kienu 0.6% u 0.5% għal Zontivity flimkien ma' kura standard u kura standard waħedha, rispettivament.
English: The effect of Zontivity on GUSTO severe or moderate bleeding relative to placebo was shown to be consistent across the subgroups examined.
Maltese: L-effett ta' Zontivity fuq fsada qawwija u moderata GUSTO mqabbel mal-plaċebo ntwera li kien konsistenti fis-sottogruppi kollha li ġew eżaminati.
English: • nefazodone (used to treat depression)
Maltese: • nefazodone (jintuża biex jikkura d-depressjoni)
English: There is limited experience with prasugrel and no experience with ticagrelor in the vorapaxar Phase 3 studies.
Maltese: Hemm esperjenza limitata bi prasugrel u ma hemm l-ebda esperjenza b'ticagrelor fl-istudji ta' Fażi 3 ta' vorapaxar.
English: Vorapaxar inhibits thrombin-induced platelet aggregation in in vitro studies.
Maltese: Vorapaxar jinibixxi t-tagħqid tal-plejtlits ikkaġunat minn thrombin fi studji in vitro.
English: Vorapaxar should not be used with prasugrel or ticagrelor (see section 4.2).
Maltese: Vorapaxar m'għandux jintuża ma' prasugrel jew ticagrelor (ara sezzjoni 4.2).
English: Because of the limited therapeutic experience and the increased inherent risk of bleeding in patients with severe hepatic impairment, Zontivity is contraindicated in such patients (see sections 4.3, 4.4, and 5.2).
Maltese: Minħabba lesperjenza terapewtika limitata u ż-żieda fir-riskju inerenti ta' fsada f'pazjenti b'indeboliment qawwi tal-fwied, Zontivity huwa kontraindikat f'pazjenti bħal dawn (ara sezzjonijiet 4.3, 4.4, u 5.2).
English: Wound haemorrhage
Maltese: Fost pazjenti wara
English: No dosage adjustment of digoxin or Zontivity is recommended.
Maltese: digoxin jew ta' Zontivity.
English: The clinical evidence for the effect of Zontivity in patients with a history of myocardial infarction, defined as a spontaneous MI ≥2 weeks but 12 months prior, is derived from TRA 2°P - TIMI 50 (Thrombin Receptor Antagonist in Secondary Prevention of Atherothrombotic Ischemic Events).
Maltese: (Antagonist tar-Riċettur ta' Thrombin fil-Prevenzjoni Sekondarja ta' Avvenimenti Aterotrombotiċi Iskemiċi - Thrombin Receptor Antagonist in Secondary Prevention of Atherothrombotic Ischemic Events).
English: Of the patients with MI without a history of stroke or TIA, 21% were receiving acetylsalicylic acid without thienopyridine, 1% was receiving a thienopyridine without acetylsalicylic acid, and 77% were receiving both acetylsalicylic acid and a thienopyridine when they enrolled in the trial.
Maltese: Mill-pazjenti b'MI mingħajr storja ta' puplesija jew TIA, 21% kienu qed jirċievu acetylsalicylic acid mingħajr thienopyridine, 1% kienu qed jirċievu wieħed mit-thienopyridines mingħajr acetylsalicylic acid, u 77% kienu qed jirċievu kemm acetylsalicylic acid kif ukoll wieħed mit-thienopyridines meta ddaħħlu fl-istudju.
English: Severe hepatic impairment increases the risk of bleeding; therefore, the use of Zontivity in these patients is contraindicated (see sections 4.2 and 5.2).
Maltese: Indeboliment qawwi tal-fwied iżid ir-riskju ta' fsada; għalhekk, l-użu ta' Zontivity f'dawn il-pazjenti huwa kontraindikat (ara sezzjonijiet 4.2 u 5.2).
English: Patients taking Zontivity should also take acetylsalicylic acid or clopidogrel according to their indications or standard of care.
Maltese: Meta ngħata flimkien mal-kura standard, ġeneralment acetylsalicylic acid u thienopyridine, mqabbel mal-kura standard waħedha,
English: Zontivity is used in adults who have had a heart attack or have a condition known as "peripheral arterial disease" (also known as poor circulation in the legs).
Maltese: Zontivity jintuża f'adulti li kellhom attakk tal-qalb jew li għandhom kondizzjoni magħrufa bħala “mard tal-arterji periferali” (magħrufa wkoll bħala ċirkulazzjoni batuta fir-riġlejn).
English: GUSTO Bleeding Categories Severe
Maltese: Kategoriji ta' Fsada GUSTO Qawwija
English: What Zontivity is
Maltese: Twaqqif ta' Zontivity
English: Of these patients, 10,080 received Zontivity (8,458 post-MI and 1,622 PAD) and 10,090 received placebo (8,439 post-MI and 1,651 PAD) in addition to standard of care, including antiplatelet therapy with acetylsalicylic acid and thienopyridine.
Maltese: MI u 1,651 b'PAD) apparti l-istandard ta' kura, inkluż terapija kontra l-plejtlits b'acetylsalicylic acid u thienopyridine.
English: Inhibition of TRAP-induced platelet aggregation at a level of ≥80% may last for 2 to 4 weeks after discontinuation of daily doses of vorapaxar sulfate 2.5 mg.
Maltese: Inibizzjoni ta' tagħqid tal-plejtlits ikkaġunat minn TRAP f'livell ta' ≥80% tista' ddum minn ġimagħtejn sa 4 ġimgħat wara t-twaqqif ta' dożi kuljum ta' 2.5 mg ta' vorapaxar sulfate.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Zontivity in one or more subsets of the paediatric population in prevention of arterial thromboembolism (see section 4.2 for information on paediatric use).
Maltese: L-Aġenzija Ewropea għall-Mediċini iddifferiet l-obbligu li jiġu ppreżentati riżultati tal-istudji b'Zontivity f'kull sett tal-popolazzjoni pedjatrika fil-prevenzjoni ta' tromboemboliżmu fl-arterji (ara sezzjoni 4.2 għal informazzjoni dwar l-użu pedjatriku).
English: The median Body Mass Index was 27.
Maltese: Il-medjan tal-Indiċi tal-Massa tal-Ġisem kien ta' 27.
English: Pre and postnatal studies in rats only showed some inconsistent developmental effects at exposures sufficiently in excess of human exposure at the RHD of 2.08 mg vorapaxar.
Maltese: Studji qabel u wara t-twelid fil-firien urew biss xi effetti inkonsistenti fuq l-iżvilupp b'esponimenti li kienu ogħla biżżejjed mill-esponiment tal-bniedem b'RHD ta' 2.08 mg vorapaxar.
English: Figure 1: Time to First Occurrence of CV death, MI, Stroke or UCR in Post-MI or PAD Patients with No History of Stroke or TIA
Maltese: Figura 1: Żmien meta Sseħħet l-Ewwel mewt CV, MI, Puplesija jew UCR f'Pazjenti Wara
English: In TRA 2°P - TIMI 50, among patients who entered the trial, those with a history of ischaemic stroke had a higher 3 year K-M event rate for ICH on Zontivity plus standard care (2.7%) than on standard care alone (0.9%).
Maltese: K-M għal ICH fuq Zontivity flimkien ma' kura standard (2.7%) milli fuq kura standard waħedha (0.9%).
English: • plan to have surgery including dental surgery
Maltese: • qed tippjana li tagħmel operazzjoni inkluż operazzjoni fis-snien
English: Renal Impairment
Maltese: Emorraġija minn ferita
English: If you stop taking Zontivity
Maltese: X'fih Zontivity
English: Merck Sharp & Dohme Ltd
Maltese: Merck Sharp & Dohme (Sweden) AB
English: Within that period the effect was similar regardless of the time from qualifying MI to the start of therapy with Zontivity.
Maltese: Inti u t-tabib tiegħek se tiddeċiedu jekk intix se tieħu Zontivity.
English: Due to the unknown potential for adverse reactions in breast-feeding infants from Zontivity, discontinue breast-feeding or discontinue Zontivity; taking into account the importance of the medicinal product to the mother.
Maltese: Minħabba li mhijiex magħrufa lpossibbiltà ta' reazzjonijiet avversi minn Zontivity fi trabi li qed jitreddgħu, waqqaf it-treddigħ jew waqqaf Zontivity; filwaqt li tiqis l-importanza tal-prodott mediċinali għall-omm.
English: EMA/353887/2016
Maltese: mikrogramma pilloli) EMA/353887/2016
English: The company wanted this change to be recognised in Austria, Belgium, Czech Republic, Denmark, Estonia, France, Germany, Greece, Ireland, Italy, Latvia, Luxembourg, the Netherlands, Norway, Poland, Portugal, Spain and Sweden.
Maltese: Il-kumpanija riedet li din il-bidla tkun rikonoxxuta fl-Awstrija, fil-Belġju, fir-Repubblika Ċeka, fid-Danimarka, fl-Estonja, fi Franza, fil-Ġermanja, fil-Greċja, fl-Irlanda, fl-Italja, fil-Latvja, fil-Lussemburgu, fin-Netherlands, finNorveġja, fil-Polonja, fil-Portugall, fi Spanja u fl-Iżvezja.
English: Outcome of a procedure under Article 13 of Regulation (EC) 1234/2008
Maltese: Riżultat ta' proċedura skont l-Artikolu 13 tar-Regolament (KE) 1234/2008
English: What is Levonelle?
Maltese: X'inhu Levonelle?
English: It is available as a single tablet containing 1500 microgram levonorgestrel or as two tablets each containing 750 microgram levonorgestrel.
Maltese: Huwa disponibbli bħala pillola waħda li fiha 1500 mikrogramma levonorgestrel jew bħala żewġ pilloli li fihom 750 mikrogramma levonorgestrel kull waħda.
English: The European Commission issued an EU-wide legally binding decision to implement the CHMP recommendations on Levonelle on 01/08/2016.
Maltese: Il-Kummissjoni Ewropea ħarġet deċiżjoni legalment vinkolanti sabiex timplimenta rrakkomandazzjonijiet tas-CHMP dwar Levonelle f'01/08/2016.
English: Levonelle is an emergency contraceptive used to prevent unintended pregnancy when taken within 72 hours (3 days) of unprotected intercourse or failure of a contraceptive method.
Maltese: Levonelle huwa kontraċettiv ta' emerġenza użat sabiex jipprevjeni t-tqala mhux intenzjonata meta jittieħed fi żmien 72 siegħa (3 ijiem) minn att sesswali mingħajr protezzjoni jew falliment ta' metodu kontraċettiv.
English: On 26 May 2016, the European Medicines Agency completed a review for the emergency contraceptive Levonelle (levonorgestrel, 1500 microgram tablets) and associated names.
Maltese: Fis-26 ta' Mejju 2016, l-Aġenzija Ewropea għall-Mediċini temmet rieżami għall-kontraċezzjoni ta' emerġenza Levonelle (levonorgestrel, pilloli ta' 1500 mikrogramma) u ismijiet assoċjati.
English: The CHMP noted that the reductions in blood levels of levonorgestrel seen with efavirenz were similar to those seen with other medicines (so-called liver enzyme inducers) that interact with levonorgestrel (including certain medicines for tuberculosis and epilepsy and herbal medicines containing St John's wort).
Maltese: Is-CHMP innota li t-tnaqqis tal-livelli ta' levonorgestrel fid-demm li deher ma' efavirenz kien simili għal dak li deher ma' mediċini oħra ('l hekk imsejħa indutturi tal-enzima tal-fwied) li jinteraġixxu ma' levonorgestrel (inkluż ċerti mediċini għat-tuberkulożi u għall-epilessija u għall-mediċini tal-ħxejjex li fihom St John's wort).
English: The company that markets these medicines is Gedeon Richter Plc.
Maltese: Il-kumpanija li tqiegħed dawn il-mediċini fis-suq hija Gedeon Richter Plc.
English: around 50% in women taking efavirenz, which is known to increase the activity of a particular liver enzyme (CYP3A4) which is involved in the breakdown of levonorgestrel.
Maltese: wera li l-livelli ta' levonorgestrel fid-demm tnaqqsu b'madwar 50% fin-nisa li jieħdu efavirenz, li huwa magħruf li jżid l-attività ta' enzima partikolari tal-fwied (CYP3A4) li hija involuta fit-tkissir ta' levonorgestrel.
English: This review only covered the 1500 microgram tablets.
Maltese: (levonorgestrel, 1500 mikrogramma pilloli)
English: Levonelle has been authorised in the EU under a mutual recognition procedure based on an initial authorisation granted by the United Kingdom on 15 June 2004.
Maltese: Levonelle ġie awtorizzat fl-UE taħt proċedura ta' rikonoxximent reċiproku abbażi ta' awtorizzazzjoni inizjali mogħtija mir-Renju Unit fil-15 ta' Ġunju 2004.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) recommended that when Levonelle is taken together with certain interacting medicines (including the HIV medicine efavirenz and ritonavir, certain medicines for tuberculosis and epilepsy and herbal medicines containing St John's wort) the dose of Levonelle should be doubled.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bnedmin (CHMP) tal-Aġenzija rrakkomanda li meta Levonelle jittieħed ma' ċerti mediċini ta' interazzjoni (inkluż il-mediċina ta' kontra l-HIV efavirenz u ritonavir, ċerti mediċini għat-tuberkulożi u għall-epilessija u għall-mediċini tal-ħxejjex li fihom St John's wort) iddoża ta' Levonelle għandha tirdoppja.
English: Based on data on interactions with these medicines, which all increase the activity of the liver enzyme CYP3A4, as well as data on combined hormonal contraceptives, the CHMP concluded that interactions between these medicines and Levonelle may prevent Levonelle from working effectively and could lead to contraceptive failure.
Maltese: Abbażi ta' dejta dwar l-interazzjonijiet ma' dawn il-mediċini, li kollha kemm huma jżidu l-attività tal-enzima tal-fwied CYP3A4, kif ukoll dejta dwar kontraċettivi ormonali kombinati, is-CHMP ikkonkluda li l-interazzjonijiet bejn dawn il-mediċini u Levonelle jistgħu jipprevjenu l-ħidma effettiva ta' Levonelle u jistgħu jwasslu għal falliment tal-kontraċettiv.
English: Levonelle contains levonorgestrel, which works mainly by preventing or delaying ovulation.
Maltese: Levonelle fih levonorgestrel, li jaħdem l-aktar billi jipprevjeni jew idewwem l-ovulazzjoni.
English: No increased risk of side effects is expected from the higher dose.
Maltese: Mhijiex mistennija żieda fir-riskju tal-effetti sekondarji mid-doża ogħla.
English: This could mean that the contraceptive effects of Levonelle are reduced.
Maltese: Dan jista' jfisser tnaqqis fl-effetti kontraċettivi ta' Levonelle.
English: However, when this is not an option, the CHMP considered that doubling the dose of Levonelle from 1500 to 3000 microgram is recommended to compensate for the reduction in blood levonorgestrel levels.
Maltese: Madankollu, meta din mhijiex għażla, is-CHMP ikkunsidra li l-irduppjar tad-doża ta' Levonelle minn 1500 għal 3000 mikrogramma huwa rrakkomandat sabiex jikkumpensa għat-tnaqqis tal-livelli ta' levonorgestrel fid-demm.