FrancophonIA/ELRC3.0 huggingface dataset:
English: Section 4.4 - Special warnings and precautions for use The information on C. difficile and antibiotic- associated colitis was re-worded in line with previous Article 30 harmonisation procedures for beta- lactams and to include hypersensitivity reactions and interactions with calcium-containing products.
Maltese: L-informazzjoni dwar C. difficile u kolite marbuta mal-antibijotiċi ġiet ifformulata mill-ġdid f'konformità ma' proċeduri preċedenti ta' armonizzazzjoni skont l-Artikolu 30 għal beta- lactams u biex tinkludi reazzjonijiet ta' sensittività eċċessiva u interazzjonijiet ma' prodotti li fihom il-kalċju.
English: It was noted that the proposal for the indication is aligned with the wording previously agreed on for similar antibiotics.
Maltese: Ġie nnotat li l-proposta għall-indikazzjoni hija allinjata mal-kliem preċedentment maqbul għal antibijotiċi simili.
English: The term convulsions has been added to the tabulated summary of adverse events in section 4.8 of the proposed SmPC following a cumulative review of the events related to convulsions during a Rocephin Periodic Safety Update Report (PSUR) work sharing procedure.
Maltese: It-terminu konvulżjonijiet ġie miżjud mas-sommarju tabulat ta' reazzjonijiet avversi fis-sezzjoni 4.8 tal-SmPC propost wara reviżjoni kumulattiva tal-avvenimenti relatati ma' konvulżjonijiet matul proċedura ta' qsim tax-xogħol tar-Rapport Perjodiku għall-Aġġornament dwar is-Sigurtà (PSUR).
English: Skin and soft tissue infections (SSTIs)
Maltese: Infezzjonijiet tal-ġilda u tat-tessut artab (SSTIs)
English: Taking into account the data from clinical studies and considerable clinical experience with ceftriaxone in the treatment of meningitis in adults and children the CHMP agreed with the harmonised indication of “Bacterial meningitis”.
Maltese: Wara li qies id-dejta minn studji kliniċi u esperjenza klinika konsiderevoli b'ceftriaxone fil-kura ta' meninġite fl-adulti u t-tfal is-CHMP qabel mal-indikazzjoni armonizzata ta' “Meninġite Batterika”.
English: Therefore the CHMP limited the indication to complicated UTI (cUTI), including pyelonephritis.
Maltese: Għalhekk is-CHMP illimita l-indikazzjoni għal UTI ikkomplikati (cUTI), inkluż pajelonefrite.
English: Data to determine the frequency of Rocephin adverse drug reactions was derived from clinical trials.
Maltese: Dejta li tiddetermina l-frekwenza ta' reazzjonijiet avversi tal-mediċina Rocephin inkisbet minn provi kliniċi.
English: Other indications
Maltese: Indikazzjonijiet oħra
English: ‘Purpura fulminans' was deleted as an indication as it was agreed that the condition is a manifestation of specific infections, all of which are already covered in the list of indications.
Maltese: ‘Purpura fulminans' tħassret bħala indikazzjoni peress li kien hemm qbil li l-kundizzjoni hija manifestazzjoni ta' infezzjonijiet speċifiċi, li kollha diġà huma koperti fil-lista ta' indikazzjonijiet.
English: Overall, there is evidence from controlled clinical trials that ceftriaxone is effective in the treatment of AOM.
Maltese: B'mod ġenerali, hemm evidenza minn provi kliniċi kkontrollati li ceftriaxone huwa effettiv fil-kura ta' AOM.
English: At the request of the CHMP, information on drug-drug interactions (DDI) with anticoagulants was included, with a recommendation that the INR (international normalised ratio) is monitored frequently.
Maltese: Fuq talba tas-CHMP, ġiet inkluża informazzjoni dwar l-interazzjonijiet bejn il-mediċini (DDI) ma' antikoagulanti, b'rakkomandazzjoni li l-INR (Proporzjon Normalizzat Internazzjonali) jiġi mmonitorjat ta' spiss.
English: The MAH has proposed wording for section 5.3 of the SmPC, which reflects the relevant non clinical data with Rocephin that may be informative for safe clinical use.
Maltese: Il-MAH ippropona kliem għas-sezzjoni 5.3 tal-SmPC, li jirrifletti d-dejta mhux klinika rilevanti b'Rocephin li tista' tkun informattiva għall-użu kliniku sigur.
English: The CHMP was of the opinion that overall, there is sufficient data from randomised controlled trials to support an indication in UTI (including pyelonephritis).
Maltese: Is-CHMP kien tal-opinjoni li b'mod ġenerali, hemm biżżejjed dejta minn provi kkontrollati u randomizzati biex jappoġġjaw indikazzjoni f'UTI (inkluż pajelonefrite).
English: The generally good tissue penetration, antibacterial activity, PK and PK/PD considerations provide scientific rationale for use of ceftriaxone in the treatment of bacterial endocarditis.
Maltese: Il-penetrazzjoni ġeneralment tajba ġot-tessut, l-attività anti-batterika, il-konsiderazzjonijiet PK u PK/PD jipprovdu raġuni xjentifika għall-użu ta' ceftriaxone fil-kura ta' endokardite batterika.
English: Due to the divergent national decisions taken by Member States concerning the authorisation of Rocephin and associated names, the European Commission notified the EMA of an official referral under Article 30 of Directive 2001/83/EC in order to resolve divergences amongst the nationally authorised product informations for the above-mentioned products and thus to harmonise them across the EU.
Maltese: Minħabba d-deċiżjonijiet nazzjonali diverġenti li ttieħdu minn Stati Membri dwar l-awtorizzazzjoni ta' Rocephin u ismijiet assoċjati, il-Kummissjoni Ewropea nnotifikat lill-EMA b'riferiment uffiċjali skont l-Artikolu 30 tad-Direttiva 2001/83/KE sabiex jiġu riżolti d-diverġenzi fl-informazzjoni dwar ilprodott awtorizzati nazzjonalment għall-prodotti msemmija hawn fuq u biex b'hekk dawn jiġu armonizzati madwar l-UE.
English: The MAH has reassigned adverse events that have not been observed in studies to the additional category, ‘Not known', with an added explanatory footnote.
Maltese: Il-MAH irriassenja avvenimenti avversi li ma jkunux ġew osservati fl-istudji għall-kategorija addizzjonali, ‘Mhux magħruf', b'nota addizzjonali ta' spjegazzjoni.
English: Considering the submitted data, the CHMP was of the view that ceftriaxone is useful in the treatment of syphilis.
Maltese: Wara li qies id-dejta ppreżentata, isCHMP kien tal-fehma li ceftriaxone huwa utli fil-kura ta' sifilide.
English: Rocephin can be administered by intravenous infusion over at least 30 minutes (preferred route) or by slow intravenous injection over 5 minutes, or by deep intramuscular injection.
Maltese: Rocephin jista' jingħata permezz ta' infużjoni ġol-vina fuq mill-inqas nofs siegħa (rotta preferuta) jew permezz ta' injezzjoni bil-mod ġo vina fuq 5 minuti, jew permezz ta' injezzjoni fil-fond ġo muskolu.
English: It is not expected that a parenteral antibacterial agent would be prescribed or appropriate in truly uncomplicated UTIs (uUTI).
Maltese: Mhuwiex mistenni li aġent antibatteriku parenterali se jiġi preskritt jew ikun adegwat f'UTIs verament mhux ikkomplikati (uUTI).
English: The half-life increases in the elderly, and in older people aged over 75 years the average elimination half-life is usually two to three times that of young adults.
Maltese: Iż-żidiet fil-half-life fl-anzjani, u f'persuni akbar fl-età ta' aktar minn 75 sena lhalf-life medja tal-eliminazzjoni hija ġeneralment darbtejn sa tliet darbiet dik ta' adulti iżgħar.
English: Based on the data presented, the same doses have been recommended for both populations - younger and older adults, provided renal and hepatic function are not relevantly impaired.
Maltese: Abbażi tad-dejta ppreżentata, l-istess dożi ġew rakkomandati għaż-żewġ popolazzjonijiet - adulti iżgħar fl-età u adulti akbar fl-età, sakemm il-funzjoni renali u epatika ma jkunux indeboliti b'mod rilevanti.
English: Therefore the MAH's proposal to add Stage II and Stage III nomenclature to this indication was considered to be acceptable by the CHMP.
Maltese: Għalhekk il-proposta tal-MAH biex iżid in-nomenklatura Stadju II u Stadju III ma' din l-indikazzjoni kienet meqjusa aċċettabbli mis-CHMP.
English: Current guidelines require indications to be specific where possible, as it was recognised that different clinical conditions summarised under LRTI have different etiology and therefore may require different treatment.
Maltese: Linji gwida attwali jeħtieġu li fejn possibbli l-indikazzjonijiet ikunu speċifiċi, peress li kien rikonoxxut li l-kundizzjonijiet kliniċi differenti mqassra taħt LRTI għandhom etjoloġija differenti u għalhekk jistgħu jeħtieġu kura differenti.
English: • The committee reviewed the data submitted by the MAH from the existing clinical studies, published literature and the cumulative safety experience with Rocephin as reported on the company's drug safety database justifying the proposed harmonisation of the Product Information.
Maltese: • Il-kumitat irreveda d-dejta ppreżentata mill-MAH mill-istudji kliniċi eżistenti, mil-letteratura ippubblikata u l-esperjenza kumulattiva dwar is-sigurtà b'Rocephin kif irrapportata fuq iddejtabase tal-kumpanija dwar is-sigurtà tal-mediċina li tiġġustifika l-armonizzazzjoni proposta tal-Informazzjoni dwar il-Prodott.
English: Lower Respiratory Tract Infections (LRTI)
Maltese: Infezzjonijiet fil-Passaġġ Respiratorju ta' Isfel (LRTI)
English: • Community-acquired pneumonia (CAP)
Maltese: • Pnewmonja li tittieħed mill-komunità (CAP)
English: The MAH has provided data to demonstrate that doses of up to 700 mg/kg of ceftriaxone had no significant effect on fertility or embryofoetal development and the studies conducted are considered adequate.
Maltese: Il-MAH ipprovda dejta biex juri li dożi sa 700 mg/kg ta' ceftriaxone ma kellhom l-ebda effett sinifikanti fuq il-fertilità jew fuq l-iżvilupp embrijufetali u l-istudji li saru huma meqjusa adegwati.
English: Therefore CHMP agreed with the wording proposed of “complicated skin and soft tissue infections”.
Maltese: Għalhekk is-CHMP qabel mal-kliem propost ta' “infezzjonijiet ikkomplikati tal-ġilda u tat-tessut artab”.
English: Taking into account the additional amendments to bring the wording is in line with the recommendations made in the Guideline on the Summary of Product Characteristics (2009), this section was considered to be acceptable by the CHMP.
Maltese: Wara li qies l-emendi addizzjonali biex il-kliem jinġieb konformi mar-rakkomandazzjonijiet li saru fil-Linja Gwida dwar is-Sommarju talKaratteristiċi tal-Prodott (2009), din is-sezzjoni kienet meqjusa bħala aċċettabbli mis-CHMP.
English: For the preparation of the harmonised product information, the MAH considered the current registered SmPCs of all EU Member States with an active registration, the published literature and the cumulative safety experience with Rocephin as reported in the company's drug safety database and reflected in the appropriate sections of the company's Core Data Sheet (CDS).
Maltese: Għat-tħejjija tal-informazzjoni armonizzata dwar il-prodott, il-MAH ikkunsidra l-SmPCs attwalment irreġistrati tal-Istati Membri kollha tal-UE b'reġistrazzjoni attiva, il-letteratura ppubblikata u lesperjenza kumulattiva dwar is-sigurtà b'Rocephin kif irrapportata fid-dejtabase tal-kumpanija dwar is-sigurtà tal-mediċina u riflessi fis-sezzjonijiet xierqa tal-Iskeda Ewlenija tad-Dejta (Core Data Sheet CDS) tal-kumpanija.
English: Total and renal plasma clearance (of total, i.e. free plus protein bound) ceftriaxone is dose dependent, while renal clearance of free ceftriaxone clearance is not.
Maltese: Ittneħħija totali u renali ta' ceftriaxone mill-plasma (mit-total, jiġifieri ħieles u marbut mal-proteini) hija dipendenti fuq id-doża, filwaqt li t-tneħħija renali ta' ceftriaxone ħieles mhijiex.
English: Bacterial Meningitis
Maltese: Meninġite Batterika
English: Rocephin is contraindicated in premature and in fullterm neonates at risk of developing bilirubin encephalopathy or receiving calcium-containing intravenous infusions.
Maltese: Rocephin huwa kontraindikat fi trabi prematuri u fi trabi tat-twelid li qegħdin f'riskju li jiżviluppaw enċefalopatija b'bilirubina jew li jkunu qed jirċievu infużjonijiet li fihom il-kalċju ġol-vini.
English: Therefore the revised indication ‘Ceftriaxone may be used in the management of neutropenic patients with fever that is suspected to be due to a bacterial infection' was proposed and considered acceptable by the CHMP.
Maltese: Għalhekk l-indikazzjoni riveduta ‘Ceftriaxone jista' jintuża fil-ġestjoni ta' pazjenti newtropeniċi b'deni li huwa suspettat li huwa dovut għal infezzjoni batterika' kienet proposta u meqjusa aċċettabbli mis-CHMP.
English: The MAH's proposed text that the symptoms of overdose - nausea, vomiting and diarrhoea cannot be reduced by haemodialysis or peritoneal dialysis and that there is no specific antidote was considered to be acceptable by the CHMP.
Maltese: It-test propost tal-MAH li s-sintomi ta' doża eċċessiva - dardir, rimettar u dijarea ma jistgħux jitnaqqsu permezz ta' emodijalisi jew dijalisi peritoneali u li ma hemm l-ebda antidotu speċifiku kien meqjus bħala aċċettabbli mis-CHMP Ġie ddikjarat li l-kura ta' doża eċċessiva għandha tkun sintomatika.
English: However in cases of severe renal and hepatic impairment, close clinical monitoring for efficacy and safety has been recommended.
Maltese: Madankollu f'każijiet ta' indeboliment renali u epatiku sever, ġie rrakkomandat monitoraġġ kliniku mill-qrib għall-effikaċja u s-sigurtà.
English: Rocephin inhibits bacterial enzymes necessary for cellwall synthesis (peptidoglycan synthesis) causing cell death.
Maltese: Dejta klinika disponibbli b'appoġġ għall-effikaċja ta' ceftriaxone fil-kura ta' sifilide hija limitata.
English: The MAH's proposal ‘Infections in patients with impaired defence mechanisms' was not considered to be sufficiently supported by data.
Maltese: Il-proposta tal-MAH ‘Infezzjonijiet f'pazjenti b'indeboliment fil-mekkaniżmi ta' difiża' ma kienitx meqjusa appoġġjata biżżejjed mid-dejta.
English: The MAH's clinical trial data all stem from open, retrospective or observational uncontrolled studies enrolling small numbers of patients.
Maltese: Id-dejta mill-prova klinika tal-MAH ġejja kollha minn studji mhux ikkontrollati, miftuħa, retrospettivi jew ta' osservazzjoni li fihom ħadu sehem għadd żgħir ta' pazjenti.
English: The MAH's proposal to delete the indication for sinusitis, pharyngitis and prostatitis due to the scarcity of robust clinical trials in these conditions was agreed by the CHMP.
Maltese: Is-CHMP qabel mal-proposta tal-MAH biex l-indikazzjoni għal sinusite, farinġite u prostatite titħassar minħabba l-iskarsezza ta' provi kliniċi robusti f'dawn il-kondizzjonijiet.
English: In view of the available data, the antimicrobial activity of ceftriaxone in the indication of uncomplicated SSTI (uSSTI) is not considered to be appropriate for this agent.
Maltese: Fid-dawl tad-dejta disponibbli, l-attività antimikrobika ta' ceftriaxone fl-indikazzjoni ta' SSTI mhux ikkomplikati (uSSTI) mhijiex meqjusa xierqa għal dan l-aġent.
English: • Hospital-acquired pneumonia (HAP)
Maltese: • Pnewmonja li tittieħed mill-isptar (HAP)
English: On balance, the CHMP considered that the indication ‘Acute exacerbations of chronic obstructive pulmonary disease' is approvable.
Maltese: Kollox ma' kollox, is-CHMP ikkunsidra li l-indikazzjoni ‘Taħrix akut ta' mard pulmonari ostruttiv kroniku' tista' tiġi approvata.
English: For example, whether pneumonia was acquired in a hospital setting or not, provides additional clues to the pathogens involved and have led to definitions of hospital-acquired pneumonia (HAP) and community-acquired pneumonia (CAP).
Maltese: Per eżempju, jekk il-pnewmonja tkunx ittieħdet fi sptar jew le, tipprovdi ħjiel addizzjonali għall-patoġeni nvoluti u dan wassal għal definizzjonijiet ta' pnewmonja li tittieħed fi sptar (HAP) u pnewmonja li tittieħed mill-komunità (CAP).
English: From the data presented for the various indications it appears that sufficient patients with bacteraemia were included in the clinical studies, which allow the conclusion that ceftriaxone can be used in the authorised indications when bacteraemia is present.
Maltese: Mid-dejta ppreżentata għall-indikazzjonijiet varji jidher li kien hemm biżżejjed pazjenti b'batterimja inklużi fl-istudji kliniċi, li jippermetti l-konklużjoni li ceftriaxone jista' jintuża fl-indikazzjonijiet awtorizzati meta jkun hemm batterimja preżenti.
English: Based on the above, the CHMP considers the benefit/risk ratio of Rocephin and associated names to be favourable and the harmonised Product Information documents to be approvable.
Maltese: Abbażi ta' dan t'hawn fuq, is-CHMP iqis lil-proporzjon tal-benefiċċju/riskju ta' Rocephin u ismijiet assoċjati huwa favorevoli u d-dokumenti armonizzati tal-Informazzjoni dwar il-Prodott jistgħu jiġu approvati.
English: The CHMP noted that most of the clinical data stem from studies labeled complicated IAI (cIAI), although these studies included a wide variety of conditions.
Maltese: Is-CHMP innota li ħafna mid-dejta klinika ġejja minn studji tikkettati bħala IAI ikkomplikati (cIAI), għalkemm dawn l-istudji kienu jinkludu varjetà wiesgħa ta' kundizzjonijiet.
English: There is sufficient data to harmonise the indication for ceftriaxone in complicated SSTI (cSSTI), since the clinical data presented stem mostly from what was labelled as cSSTI.
Maltese: Hemm biżżejjed dejta biex lindikazzjoni għal ceftriaxone f'SSTI ikkomplikati (cSSTI) tiġi armonizzata, peress li d-dejta klinika ppreżentata ġejja prinċipalment minn dak li kien ttikkettat bħala cSSTI.
English: WHAT [invented name] IS AND WHAT IT IS USED FOR
Maltese: Mard tal-qalb (attakk tal-qalb).
English: - Systemic lupus erythematosus
Maltese: - Lupus erythematosus sistemiku
English: There are no data available.
Maltese: M'hemm l-ebda data disponibbli.
English: Note
Maltese: Nota
English: The following values were determined after single-dose administration of 2 g [invented name], equivalent to 200 µg E2: AUCδ0-∞ = 887.5 pg/ml*h; AUCδ0-tz = 799.5 pg/ml*h; Cδmax = 86.2 pg/ml.
Maltese: ekwivalenti għal 200 µg E2: AUCδ0-∞ = 887.5 pg/ml*h; AUCδ0-tz = 799.5 pg/ml*h; Cδmax =
English: System organ class (MedDRA)
Maltese: Sistema talklassi talorgani (MedDRA)
English: Vaginitis, including vaginal candidiasis
Maltese: Vaginite, inkluż kandidjasi vaġinali
English: Very rare: allergic reactions.
Maltese: Rari ħafna: reazzjonijiet allerġiċi.
English: System Organ Class
Maltese: Sistema tal-Klassi talOrgani
English: Medical history and regular check-ups
Maltese: Storja medika u visti mediċi regolari
English: Part B. - 0.005 % w/w estradiol / 0.4 % w/w prednisolone containing medicinal products
Maltese: Parti B. - prodotti mediċinali li fihom 0.005 % w/w estradiol / 0.4 % w/w prednisolone
English: - Leiomyoma (uterine fibroids) or endometriosis
Maltese: - Leiomyoma (fibrojdi tal-utru) jew endometrijożi
English: Other plasma proteins may be increased (angiotensinogen/renin substrate, alpha-1antitrypsin, ceruloplasmin).
Maltese: anġjotensinoġen/renin, alpha-1-antitrypsin, ceruloplasmin).
English: (≥1/1,000 to <1/100)
Maltese: (≥1/1,000 sa <1/100)
English: Herbal preparations containing St John's Wort (Hypericum Perforatum) may induce the metabolism of oestrogens.
Maltese: Preparazzjonijiet erbali li fihom St John's Wort (Hypericum Perforatum) jistgħu jinduċu lmetaboliżmu tal-estroġeni.
English: Coronary artery disease (CAD)
Maltese: Marda fl-arterja koronarja (CAD)
English: As an active substance, [invented name] contains 17ß-estradiol (0.005%).
Maltese: Bħala sustanza attiva, [isem ivvintat] fih 17ß-estradiol (0.005%).
English: Venous thrombosis, pulmonary embolism
Maltese: Trombożi fil-vini, emboliżmu pulmonari
English: Free T4 and free T3 concentrations are unaltered.
Maltese: Il-konċentrazzjonijiet T4 liberi u T3 liberi mhumiex mibdula.
English: Age range (years)
Maltese: Medda ta' età (snin)
English: - Epilepsy
Maltese: - Epilessija
English: Endometrial hyperplasia and carcinoma
Maltese: Iperplażja endometrijali u karċinoma
English: Risk ratio and 95% CI
Maltese: Proporzjon ta' riskju u 95 % CI
English: According to the current, standard classification system for topical corticosteroids, i.e. weak (I), moderately potent (II), potent (III) and very potent (IV), prednisolone - closely related to natural hydrocortisone (= cortisol) - belongs to the first group.
Maltese: Skont is-sistema standard ta' klassifikazzjoni għal kortikosterojdi topiċi, jiġifieri dgħajfa (I), potenti b'mod moderat (II), potenti (III) u potenti ħafna (IV), prednisolone - relatat mill-qrib ma' hydrocortisone naturali (= cortisol) - jagħmel parti mill-ewwel grupp.
English: [invented name] belongs to a group of medicines called local Hormone Replacement Therapy (HRT).
Maltese: [isem ivvintat] jagħmel parti minn grupp ta' mediċini msejħa Terapija lokali ta' Sostituzzjoni tal-Ormoni (HRT).
English: Chloasma/melasma, hirsutism, pruritus, rash
Maltese: Kloasma/melasma, żieda fix-xagħar (hirsutism), ħakk, raxx
English: However, the metabolism of oestrogens may be increased by concomitant use of substances known to induce drug-metabolising enzymes, specifically cytochrome P450 enzymes, such as anticonvulsants (e.g. phenobarbital, phenytoin, carbamazepine) and anti-infectives (e.g. rifampicin, rifabutin, nevirapine, efavirenz).
Maltese: Madankollu, il-metaboliżmu ta' estroġeni jista' jiżdied bl-użu konkomitanti ta' sustanzi magħrufa li jinduċu enzimi li jimmetabolizzaw il-prodotti mediċinali, b'mod speċifiku enzimi cytochrome P450, bħal antikonvulsivi (eż. phenobarbital, phenytoin, carbamazepine) u anti-infettivi (eż. rifampicin, rifabutin, nevirapine, efavirenz).
English: Common ≥ 1/100 to < 1/10 (≥ 1% and
Maltese: Komuni ≥ 1/100 sa < 1/10 (≥ 1% u
English: Section 5.2 Pharmacokinetic properties
Maltese: Sezzjoni 5.2 Tagħrif farmakokinetiku Estradiol
English: Insert the contents of 1 filled applicator (= 2 g cream) before bedtime.
Maltese: Daħħal il-kontenut ta' applikatur mimli wieħed (= 2 g krema) qabel ma tmur torqod.
English: Section 4.6 Fertility, Pregnancy and lactation
Maltese: Sezzjoni 4.6 Fertilità, tqala u treddigħ
English: The active ingredient, synthetic 17β-estradiol, is chemically and biologically identical to endogenous human estradiol.
Maltese: Is-sustanza attiva, 17β-estradiol sintetiku, hija kimikament u bijoloġikament identika għal estradiol endoġenu tal-bniedem.
English: - history of malignant oestrogen-dependent tumours - tumours of the womb (leiomyoma, uterine myoma).
Maltese: - storja ta' tumuri malinni dipendenti mill-estroġenu - tumuri fl-utru (leiomyoma, myoma fl-utru).
English: Risk ratio and 95% CI Additional cases per 1000 HRT user 5 years (95% CI)
Maltese: Proporzjon ta' riskju Każijiet addizzjonali għal kull 1000 utent ta' HRT 5 snin (95% CI)
English: Additional cases per 1000 HRT user 5 years (95% CI)
Maltese: Każijiet addizzjonali għal kull 1000 utent ta' HRT 5 snin (95% CI)
English: Uncommon > 1/1000 to <1/100 (> 0.1% and
Maltese: Mhux komuni > 1/1000 sa <1/100 (> 0.1% u <1%)
English: See sction 4.2 and
Maltese: Ara sezzzjoni 4.2 u 4.4.
English: 17β-Estradiol is a well-known substance.
Maltese: 17β-Estradiol hija sustanza magħrufa sew.
English: Generally recognised risk factors for VTE include use of oestrogens, older age, major surgery, prolonged immobilisation obesity (BMI>30 kg/m2), pregnancy/postpartum period, systemic lupus erythematosus (SLE), and cancer.
Maltese: Fatturi ta' riskju rikonoxxuti b'mod ġenerali għall-VTE jinkludu l-użu ta' estroġeni, età akbar, kirurġija maġġuri, obeżità li twassal għal immobilizzazzjoni fit-tul (BMI>30 kg/m2), perjodu tat-tqala/twelid, lupus erythematosus sistemiku (SLE), u kanċer.
English: - Cholelithiasis
Maltese: - Kolelitijasi
English: The pharmacokinetic profile of [Invented name] shows that there is systemic absorption of estradiol during treatment, in concentrations which are transiently above the postmenopausal levels (see Section 5.2).
Maltese: Il-profil farmakokinetiku ta' [Isem ivvintat] juri li hemm assorbiment sistemiku ta' estradiol matul il-kura, f'konċentrazzjonijiet li huma temporanjament 'il fuq mil-livelli wara lmenopawża (ara Sezzjoni 5.2).
English: Over 95% of estriol is excreted in the urine, mainly in the form of glucuronides.
Maltese: Aktar minn 95% ta' estriol jiġi eliminat fl-awrina, prinċipalment fil-forma ta' glukuronidi.
English: Estradiol is rapidly metabolised in the liver and intestinal tract to estrone and subsequently to estriol.
Maltese: Estradiol huwa metabolizzat rapidament fil-fwied u l-apparat intestinali għal estrone u sussegwentement għal estriol.