FrancophonIA/ELRC3.0 huggingface dataset:
English: • The implementing measures for the falsified medicines legislation (public consultations on unique identifier finishes 27 April 2012, on GMP for active substances from non-EU countries finishes 23
Maltese: • Il-miżuri implimentattivi għal-leġiżlazzjoni dwar il-mediċini ffalsifikati (il-konsultazzjoni pubblika dwar identifikatur uniku tintemm fis-27 ta' April 2012, dwar il-GMP għal sustanzi attivi minn pajjiżi mhux tal-UE tintemm fit-23 ta' Marzu 2012, dwar il-prinċipji u l-linji gwida tal-GMP għal sustanzi attivi ntemmet fl-20 ta' April 2012).
English: Initiatives to set up the system for the review of raw clinical-trial data will be undertaken.
Maltese: Sejrin isiru inizjattivi biex titwaqqaf is-sistema għall-analiżi ta' dejta mill-provi kliniċi.
English: There was a 10% increase in the number of applications for initial-marketing authorisation for medicines for human use, with 100 applications received in 2011.
Maltese: Kien hemm żieda ta' 10% fin-numru ta' applikazzjonijiet għal awtorizzazzjoni inizjali għattqegħid fis-suq għall-mediċini għall-użu mill-bniedem, b'100 applikazzjoni li daħlu fl-2011.
English: • EMA/135591/2012 Annual report 2011 of the Agency's Audit Advisory Committee.
Maltese: • EMA/135591/2012 Rapport annwali 2011 tal-Kumitat Konsultattiv tal-Aġenzija dwar l-Awditjar.
English: • Presentation on PRAC rapporteurs: Proposed principles for appointment and roles/responsibilities of PRAC rappoerteurs.
Maltese: Prinċipji proposti għall-ħatra u r-rwoli/irresponsabbiltajiet tar-rapporteurs tal-PRAC.
English: The Board continued discussions held at the meeting of the Heads of Medicines Agencies in February 2012.
Maltese: Il-Bord kompla bid-diskussjonijiet li saru fil-laqgħa tal-Kapijiet tal-Aġenziji għall-Mediċini li saret fi Frar 2012.
English: The Board was informed that, to date, the Agency has introduced a revised policy on managing conflicts of interests of experts, adopted rules on managing conflicts of interests of staff, discussed the Management Board policy and presented it for adoption at this meeting, drafted the breach of trust procedure, is introducing ex post controls, has published risk ratings for committee members, and has
Maltese: Il-Bord ġie mgħarraf li, sa dak in-nhar, l-Aġenzija kienet introduċiet politika riveduta dwar ilġestjoni ta' kunflitti ta' interessi ta' esperti, adottat regoli dwar il-ġestjoni tal-kunflitti ta' interess talpersunal, iddiskutiet il-politika tal-Bord ta' Tmexxija u ppreżentatha għall-addozzjoni f'din il-laqgħa, abbozzat il-proċedura dwar ksur tal-fiduċja, qiegħda tintroduċi kontrolli ex post, ippubblikat gradi tarriskju għall-membri tal-kumitat, u ppubblikat profili professjonali tal-maniġers u l-membri tal-kumitat tal-Aġenzija u tal-membri tal-Bord ta' Tmexxija.
English: • inclusion of a reference to a system of ex-post checks, as well as the development of a breach of trust procedure.
Maltese: • l-inklużjoni ta' referenza għal sistema ta' verifiki ex-post, kif ukoll l-iżvilupp ta' proċedura dwar ilksur ta' fiduċja.
English: Committee on Herbal Medicinal Products (HMPC) in June to discuss topics relating to herbal medicines.
Maltese: Il-Bord sejjer jiltaqa' mal-President tal-Kumitat dwar il-Prodotti Mediċinali Erbali (HMPC) f'Ġunju biex jiddiskuti suġġetti relatati mal-mediċini erbali.
English: EMA/MB/221361/2012 Adopted Management Board
Maltese: EMA/518113/2012 Adottat Bord ta' Tmexxija
English: The number of applications received for initial-marketing authorisation for veterinary medicines declined slightly.
Maltese: In-numru ta' applikazzjonijiet li daħlu għal awtorizzazzjoni inizjali għat-tqegħid fis-suq għall-mediċini veterinarji naqas bi ftit.
English: The procedure concerns any incomplete and/or incorrect declarations of interests.
Maltese: Dikjarazzjoni tal-kunflitti ta' interessi relatati mal-aġenda attwali
English: • The proposal for the transparency directive, which, among many measures, clarifies the scope, reduces the time limits for pricing and reimbursement decisions, and addresses the grouping of medicines for reimbursement purposes.
Maltese: • Il-proposta għad-direttiva dwar it-trasparenza, li, fost bosta miżuri, tiċċara l-kamp ta' applikazzjoni, tnaqqas il-limiti taż-żmien għad-deċiżjonijiet dwar l-ipprezzar u r-rimborż, u tindirizza t-tqegħid ta' mediċini fi gruppi għal skopijiet ta' rimborż.
English: Adaptive licensing can be defined as a prospectively planned, adaptive approach to regulation of drugs through iterative phases of evidence-gathering, followed by regulatory evaluation and license adaptation.
Maltese: Il-liċenzjar adattiv jista' jiġi definit bħala approċċ adattiv ippjanat b'mod prospettiv għarregolamentazzjoni tal-mediċini permezz ta' fażijiet iterattivi ta' ġbir ta' provi, segwit minn evalwazzjoni u adattament tal-liċenzja.
English: A broader constellation of stakeholders has to participate, including the clinical community, healthcare providers, patients, payers and industry.
Maltese: Irid ikun hemm parteċipazzjoni minn firxa usa' ta' partijiet interessati, inklużi l-komunità klinika, il-fornituri tal-kura tas-saħħa, il-pazjenti, dawk li jħallsu u l-industrija.
English: Minutes of the 75th meeting of the Management Board
Maltese: Minuti tal-75 laqgħa tal-Bord ta' Tmexxija
English: Future reflection should therefore consider at which stage of the decision process a public hearing would be most valuable (e.g. when addressing benefit-risk or borderline issues).
Maltese: Għaldaqstant, irriflessjoni tal-ġejjieni għandha tqis f'liema stadju tal-proċess ta' teħid ta' deċiżjonijiet ikun l-iktar utli smigħ pubbliku (eż. meta jiġu indirizzati kwistjonijiet dwar il-benefiċċji u r-riskji u dawk inċerti).
English: • Presentation on proposal for a directive of the European Parliament and the Council relating to the transparency measures regulating the prices of medicinal products for human use and their inclusion in the scope of public health insurance systems.
Maltese: • Preżentazzjoni dwar proposta għal direttiva tal-Parlament Ewropew u l-Kunsill relatata mal-miżuri ta' trasparenza li jirregolaw il-prezzijiet tal-prodotti mediċinali għall-użu mill-bniedem u l-inklużjoni tagħhom fil-kamp ta' applikazzjoni tas-sistemi pubbliċi ta' assigurazzjoni tas-saħħa.
English: Pharmacovigilance Risk Assessment Committee a.) Consultation procedure on final composition
Maltese: Kumitat dwar il-Valutazzjoni tar-Riskji talFarmakoviġilanza a.) Proċedura ta' konsultazzjoni dwar l-għamla finali
English: The Agency's financing of the pilot phase will amount to over EUR 350,000 in 2012.
Maltese: Fl-2012, ilfinanzjament tal-Aġenzija tal-fażi pilota sejjer jammonta għal iktar minn EUR 350,000.
English: The implementation plan has been completed, including the assignment of risk levels, the implementation of mitigation procedures and the provision of training.
Maltese: Il-pjan ta' implimentazzjoni tlesta, inkluż l-assenjament tal-livelli ta' riskju, l-implimentazzjoni ta' proċeduri ta' mitigazzjoni u l-għoti ta' taħriġ.
English: A group has been set up to propose alternatives at the June meeting.
Maltese: Fil-laqgħa ta' Ġunju twaqqaf grupp biex jipproponi alternattivi.
English: b.) Revised conflicts of interests policy for experts
Maltese: b.) Politika riveduta dwar il-kunflitti ta' interessi għall-esperti
English: • Publication of agendas and minutes.
Maltese: • Pubblikazzjoni tal-aġendi u l-minuti.
English: Wednesday meeting, held on 21 March 2012
Maltese: Laqgħa ta' nhar l-Erbgħa, li saret fil-21 ta' Marzu 2012
English: The concept is being debated among regulators worldwide, and is referred to in the Agency's strategy document on the subject, which states that a key issue for regulators will be whether a more staggered approval concept should be envisaged for situations not covered by conditional marketing authorisations.
Maltese: Il-kunċett qiegħed jiġi diskuss bejn ir-regolaturi ta' madwar id-dinja, u ssir referenza għalih fid-dokument strateġiku tal-Aġenzija dwar is-suġġett, li jiddikjara li kwistjoni ewlenija għar-regolaturi sejra tkun jekk għandux jiġi previst kunċett ta' approvazzjoni iktar imxengla għal sitwazzjonijiet mhux koperti minn awtorizzazzjonijiet kundizzjonali għat-tqegħid fis-suq.
English: The Chair of the HMA management group provided an update on a number of items, including the following:
Maltese: Il-President tal-grupp ta' tmexxija tal-HMA pprovda aġġornament fuq numru ta' elementi, inklużi dawn li ġejjin:
English: The agencies then signed a memorandum of understanding setting out their commitment to fostering cooperation.
Maltese: Imbagħad l-aġenziji ffirmaw memorandum ta' ftehim li jistabbilixxi l-impenn tagħhom biex irawmu kooperazzjoni.
English: The participants stressed that the pharmacovigilance system should be supported by fees, which are foreseen in the legislation but will not come into force until after a few years.
Maltese: Il-parteċipanti saħqu li s-sistema ta' farmakoviġilanza għandha tkun sostnuta minn tariffi, li huma previsti fil-leġiżlazzjoni iżda li mhumiex sejrin jidħlu fis-seħħ qabel ftit snin oħra.
English: • Written procedure for adoption of the 74th Management Board meeting minutes closed on 9 February 2011.
Maltese: • Proċedura bil-miktub għall-adozzjoni tal-minuti tal-74 laqgħa tal-Bord ta' Tmexxija magħluqa fid-9 ta' Frar 2011.
English: The Federal Commission for the Protection against Sanitary Risk published professional profiles of the Agency's managers, committee members and Management Board members.
Maltese: Il-Kummissjoni Federali għall-Protezzjoni kontra r-Riskju Sanitarju
English: Another proposal offered, which would allow knowledge about a product that had been gathered at the pre-authorisation stage to be retained, was to appoint the PRAC rapporteur from among the experts who had acted as peer-reviewers in the pre-authorisation phase.
Maltese: Proposta oħra offruta, li tkun tippermetti li jinżamm l-għarfien dwar prodott li jkun inġabar fl-istadju ta' qabel l-awtorizzazzjoni, kienet li jinħatar rapporteur tal-PRAC minn fost l-esperti li aġixxew bħala reviżuri bejn il-pari fil-fażi ta' qabel l-awtorizzazzjoni.
English: [EMA/MB/955795/2012] The Management Board noted the document outlining the high-level budgetary requirements for 'Project 2014' (the move of the Agency to its new premises).
Maltese: [EMA/MB/955795/2012] Il-Bord ta' Tmexxija ħa nota tad-dokument li jispjega r-rekwiżiti baġitarji ta' livell għoli għall-'Proġett 2014' (iċ-ċaqliq tal-Aġenzija għall-bini l-ġdid tagħha).
English: The Board also set up a group for the analysis and assessment of the Executive Director's annual activity report 2011, with the following members: Xavier De Cuyper, Martina Cvelbar and Gro Wesenberg.
Maltese: Il-Bord waqqaf ukoll grupp għall-analiżi u l-valutazzjoni tar-rapport tal-attività annwali tal-2011 tadDirettur Eżekuttiv, bil-membri li ġejjin:
English: This is particularly relevant due to the fact that the CHMP and CMD(h) may take a different view after the PRAC opinion has been put in the public domain.
Maltese: Dan huwa partikolarment relevanti minħabba l-fatt li s-CHMP u s-CMD(h) jista' jkollhom fehmiet differenti wara li tidħol fid-dominju pubbliku l-opinjoni tal-PRAC.
English: The formal process of reviewing nominations and identifying areas requiring reinforcement will take place at the June meeting.
Maltese: Il-proċess formali ta' reviżjoni tan-nominazzjonijiet u l-identifikazzjoni taloqsma li jeħtieġu tisħiħ sejrin isiru fil-laqgħa ta' Ġunju.
English: The Agency also plans to carry out ex-post checks on risk-mitigating actions and ex-ante controls to ensure that interests are included in correct parts of DoI forms.
Maltese: L-Aġenzija tippjana wkoll li twettaq verifiki ex-post fuq azzjonijiet ta' mitigazzjoni tar-riskji u kontrolli ex-ante biex tiżgura li l-interessi jkunu inklużi fil-partijiet korretti tal-formoli tad-DoI. Dan huwa importanti biex jiġi żgurat li l-livelli ta' riskju korretti jkunu ġġenerati mis-sistema.
English: The final policy will be sent to the Board, together with a request for its members to complete a new declaration of interests.
Maltese: Il-politika finali sejra tintbagħat lill-Bord, flimkien ma' talba għall-membri tiegħu sabiex jipprovdu dikjarazzjoni tal-interessi ġdida.
English: The minutes were adopted.
Maltese: Il-minuti ġew adottati.
English: [EMA/MB/121516/2012] The Board adopted the Agency's preliminary draft budget and the draft establishment plan for 2013.
Maltese: [EMA/MB/121516/2012] Il-Bord adotta l-abbozz tal-baġit preliminari tal-Aġenzija u l-abbozz tal-pjan ta' stabbiliment għall-2013.
English: • The implementing measures of the pharmacovigilance legislation (planned adoption in Q2 2012).
Maltese: • Il-miżuri implimentattivi tal-leġiżlazzjoni dwar il-farmakoviġilanza (adozzjoni ppjanata fit-tieni trimestru tal-2012).
English: These include: implementation of the pharmacovigilance legislation without the bridging budget or pharmacovigilance fees, and without the possibility of remunerating national competent authorities; no additional financial resources for the implementation of the falsified medicines legislation; the need to finance the move to new premises; and a likely requirement to finance the employer's part of the pension contribution.
Maltese: Dawn jinkludu: limplimentazzjoni tal-leġiżlazzjoni dwar il-farmakoviġilanza mingħajr it-tariffi li jirkupraw għall-baġit jew tal-farmakoviġilanza, u mingħajr il-possibilità li l-awtoritajiet kompetenti nazzjonali jirċievu remunerazzjoni; ebda riżorsi finanzjarji addizzjonali għall-implimentazzjoni tal-leġiżlazzjoni dwar ilmediċini ffalsifikati; il-bżonn li jiġi ffinanzjat iċ-ċaqliq għall-bini l-ġdid; u l-bżonn probabbli li tiġi ffinanzjata l-parti ta' min iħaddem tal-kontribuzzjoni tal-pensjonijiet.
English: Thursday meeting, held on 22 March 2012
Maltese: Il-laqgħa tal-Ħamis, li saret fit-22 ta' Marzu 2012
English: EU/1/14/967/001 Rezolsta
Maltese: EU/1/14/967/001
English: 800 mg/150 mg Film-coated tablet Oral use
Maltese: 800 mg/150 mg Pillola miksija b'rita
English: Strength
Maltese: Rezolsta
English: Bottle (HDPE) 30 tablets
Maltese: Flixkun (HDPE)
English: Venous thromboembolism can be fatal in 1-2% of cases.
Maltese: Tromboemboliżmu fil-vini jista' jkun fatali f'1-2% tal-każijiet.
English: It has a similar composition to that of a combined oral contraceptive (COC).
Maltese: Huwa għandu kompożizzjoni simili għal dik ta' kontraċettiv kombinat orali (COC - combined oral contraceptive).
English: • Concomitant use with another hormonal contraceptive (see section 4.1)
Maltese: • Użu flimkien ma' kontraċettiv ormonali ieħor (ara sezzjoni 4.1)
English: • Hereditary or acquired predisposition for venous or arterial thrombosis, such as activated protein C (APC) resistance, antithrombin-III-deficiency, protein C deficiency, protein S deficiency, hyperhomocysteinaemia and antiphospholipid-antibodies (anticardiolipin-antibodies, lupus anticoagulant)
Maltese: • Predispożizzjoni ereditarja jew akkwistati għal trombożi fil-vini jew fl-arterji, bħal reżistenza għall-proteina Ċ attivata (APC - activated protein C), nuqqas ta' antithrombin-III, nuqqas talproteina Ċ, nuqqas tal-proteina S, iperomosistejnimja u antikorpi kontra l-fosfolipidi (anticardiolipin-antibodies, antikoagulant lupus)
English: • Epidemiological studies have shown that the incidence of VTE is 1.5 to 2 times higher in users of <invented name> than in users of levonorgestrel-containing combined oral contraceptives (COCs) and may be similar to the risk for desogestrel / gestodene / drospirenone-containing COCs.
Maltese: • Studji epidemjoloġiċi wrew li l-inċidenza ta' VTE hija 1.5 darbiet sa darbtejn ogħla fl-utenti ta' <isem ivvintat> milli fl-utenti ta' kontraċettivi kombinati orali (COCs - combined oral contraceptives) li fihom levonorgestrel u tista' tkunu simili għar-riskju ta' COCs li fihom desogestrel / gestodene / drospirenone.
English: [The following to be included in the table of adverse reactions] • Vascular Disorders Rare (≥ 1/10,000 to < 1/1000): Thromboembolism
Maltese: Rari (≥ 1/10,000 sa < 1/1000):
English: Adequate contraception should be initiated because of the teratogenicity of anti-coagulant therapy (coumarins).
Maltese: Kontraċezzjoni adegwata għandha tinbeda minħabba itteratoġeniċità ta' terapija kontra l-koagulazzjoni (coumarins).
English: • Venous thromboembolic disorders
Maltese: • Disturbi tromboemboliċi fil-vini
English: • Arterial thromboembolic disorders
Maltese: • Disturbi tromboemboliċi fl-arterji
English: • Symptoms of venous or arterial thrombosis or of a cerebrovascular accident can include: unusual unilateral leg pain and / or swelling; sudden severe pain in the chest, whether or not it radiates to the left arm; sudden breathlessness; sudden onset of coughing; any unusual, severe, prolonged headache; sudden partial or complete loss of vision; diplopia; slurred speech or aphasia; vertigo; collapse with or without focal seizure; weakness or very marked numbness suddenly affecting one side or one part of the body; motor disturbances; ‘acute' abdomen
Maltese: • Sintomi ta' trombożi fil-vini jew fl-arterji jew ta' inċident ċerebrovaskulari jistgħu jinkludu: uġigħ u/jew nefħa mhux tas-soltu unilaterali fir-riġel; uġigħ sever f'daqqa fis-sider, kemm jekk jinfirex lejn id-driegħ tax-xellug kif ukoll jekk le; qtugħ ta' nifs f'daqqa; bidu għal għarrieda ta' sogħla; kwalunkwe uġigħ ta' ras severa u fit-tul mhux tas-soltu; telf parzjali jew komplut tal-vista f'daqqa; vista doppja; kliem ma jiġix ippronunzjat tajjeb jew afasja; vertigo; kollass flimkien ma' jew mingħajr aċċessjoni fokali; dgħufija jew tnemnim qawwi ħafna għal għarrieda li jaffettwaw naħa waħda jew parti waħda tal-ġisem; disturbi motorji; uġigħ sever f'daqqa fl-addome
English: Other medical conditions, which have been associated with adverse circulatory events, include diabetes mellitus, systemic lupus erythematosus, hemolytic uraemic syndrome, chronic inflammatory bowel disease (e.g. Crohn's disease or ulcerative colitis) and sickle cell disease.
Maltese: Kondizzjonijiet mediċi oħra, li ġew assoċjati ma' avvenimenti avversi fiċ-ċirkolazzjoni, jinkludu dijabete mellitus, lupus erythematosus sistemiku, sindrome ta' ureċimija emolitika, marda kronika infjammatorja tal-musrana (eż. marda ta' Crohn jew kolite ulċerattiva) u marda taċċellula forma ta' minġel.
English: [The following to be included below the table of adverse reactions]
Maltese: [Li ġej għandu jiġi inkluż fit-tabella ta' reazzjonijiet avversi]
English: Circulatory disorders
Maltese: Tromboemboliżmu
English: • Arterial thrombosis present or in history (e.g. myocardial infarction) or prodromal conditions (e.g. angina pectoris and transient ischaemic attack).
Maltese: • Trombożi fl-arterji preżenti jew fil-passat (eż. infart mijokardijaku) jew kondizzjonijiet prodromiċi (eż. anġina pectoris u attakk iskemiku temporanju).
English: • The presence of a severe or multiple risk factor(s) for venous or arterial thrombosis (see section 4.4) such as: o diabetes mellitus with vascular symptoms o severe hypertension o severe dyslipoproteinaemia
Maltese: • Il-preżenza ta' fattur(i) ta' riskju severi jew multipli għall-trombożi fil-vini jew fl-arterji (ara sezzjoni 4.4) bħal: o dijabete mellitus b'sintomi vaskulari o pressjoni għolja severa o dislipoprotenimja severa
English: Package Leaflet
Maltese: TAL-PRODOTT
English: • Epidemiological studies have also associated the use of hormonal contraceptive with an increased risk for arterial (myocardial infarction, transient ischaemic attack) thromboembolism.
Maltese: • Studji epidemjoloġiċi assoċjaw ukoll l-użu ta' kontraċettivi ormonali ma' riskju akbar ta' tromboemboliżmu fl-arterji (infart mijokardijaku, attakk iskemiku temporanju).
English: Women over 35 years of age should be strongly advised not to smoke if they wish to use <invented name>); - dyslipoproteinemia; - obesity (body mass index over 30 kg/m2);
Maltese: Jekk l-użu ta' <isem ivvintat> ma twaqqafx minn qabel għandha tiġi kkunsidrata kura antitrombotika; - obesità (indiċi tal-massa tal-ġisem ta' aktar minn 30 kg/m2).
English: The risk is not as high as the risk of developing a blood clot during pregnancy.
Maltese: Ir-riskju huwa inqas mir-riskju li tiżviluppa embolu tad-demm waqt it-tqala.
English: • The risk of venous thromboembolic events increases with: - increasing age; - smoking (with heavier smoking and increasing age the risk further increases, especially in women over 35 years of age.
Maltese: • Ir-riskju ta' avvenimenti tromboemboliċi fil-vini jiżdied b': - żieda fl-età; - tipjip (b'tipjip aktar qawwi u żieda fl-età r-riskju jiżdied aktar, speċjalment f'nisa b'età 'l fuq minn 35 sena.
English: A full recovery is not always made and in 1-2% of cases, can be fatal.
Maltese: Irkupru sħiħ mhux dejjem issir u f'1-2% tal-każijiet jistgħu jkunu fatali.
English: - hypertension; - migraine; - valvular heart disease; - atrial fibrillation; - a positive family history (arterial thrombosis ever in a sibling or parent at a relatively early age).
Maltese: - obesità (indiċi tal-massa tal-ġisem ta' aktar minn 30 kg/m2); - pressjoni għolja; - emigranja; - mard tal-valvs tal-qalb; - fibrillazzjoni atrijali; - passat pożittiv fil-familja (jiġifieri jekk qatt kien hemm tromboemboliżmu f'xi ħadd millaħwa jew ġenituri f'età relattivament żgħira).
English: Section 4.3 Contraindications [The following contraindications related to thromboembolism should be included in this section]
Maltese: 4.3 Kontraindikazzjonijiet [Il-kontraindikazzjonijiet relatati li ġejjin għandhom jiġu nklużi f'din is-sezzjoni]
English: The symptoms are described in section 2 ‘Blood clots (Thrombosis)'.
Maltese: Is-sintomi huma deskritti f'sezzjoni 2 ‘Emboli tad-demm (Trombożi)'.
English: • There is an increased risk of thromboembolism for all women who use <invented name> (see section 4.4).
Maltese: • Hemm żieda fir-riskju ta' tromboemboliżmu għan-nisa kollha li jużaw <isem ivvintat> (ara sezzjoni 4.4).
English: • Venous thrombosis present or in history (deep venous thrombosis, pulmonary embolism)
Maltese: • Trombożi fil-vini preżenti jew fil-passat (trombożi fil-vini l-fondi, emboliżmu pulmonari)
English: The increased risk of thromboembolism in the puerperium must be considered (for information on ‘Pregnancy and lactation' see section 4.6).
Maltese: Għandu jiġi kkunsidrat riskju akbar ta' tromboemboliżmu fil-puerperu (għal informazzjoni dwar "Tqala u treddigħ" ara sezzjoni 4.6).
English: A blood clot in a vein (known as a ‘venous thrombosis') can block the vein.
Maltese: Embolu tad-demm f'vina (magħruf bħala ‘trombożi fil-vina') jista' jimblokka l-vina.
English: Possible side effects [This wording should be added under ‘Rare side effects'] Venous blood clot.
Maltese: Effetti sekondarji possibbli [Dan il-kliem għandu jiżdied taħt ‘Effetti sekondarji rari'] Embolu tad-demm fil-vina.
English: Using a combined pill increases a woman's risk of developing such clots compared with a woman not taking any combined pill.
Maltese: L-użu ta' pillola kontraċettiva kkombinata jżid ir-riskju ta' mara li tiżviluppa emboli bħal dawn meta mqabbel ma' mara li mhux qed tieħu xi pillola kontraċettiva kombinata.
English: Section 4.4 Special warnings and precautions for use [The wording below should be inserted in this section] <invented name> is composed of the progestogen cyproterone acetate and the oestrogen ethinylestradiol and is administered for 21 days of a monthly cycle.
Maltese: <Isem ivvintat> huwa magħmul mill-proġestoġen cyproterone acetate u l-estroġen ethinylestradiol u jingħata għal 21 ġurnata ta' ċiklu ta' xahar.
English: • Presence or history of cerebrovascular accident
Maltese: • Preżenza jew passat ta' aċċident ċerebrovaskulari
English: The risk of arterial thromboembolic complications or of a cerebrovascular accident increases with: - increasing age; - smoking (with heavier smoking and increasing age the risk further increases, especially in women over 35 years of age.
Maltese: - żieda fl-età; - tipjip (b'tipjip aktar qawwi u żieda fl-età r-riskju jiżdied aktar, speċjalment f'nisa b'età 'l fuq minn 35 sena.