FrancophonIA/ELRC3.0 huggingface dataset:
English: {Augmentin and associated names (see Annex I) 400 mg/57 mg powder for oral suspension in sachets} {Augmentin and associated names (see Annex I) 200 mg/28.5 mg/5 ml powder for oral suspension} {Augmentin and associated names (see Annex I) 400 mg/57 mg/5 ml powder for oral suspension (strawberry flavour)} {Augmentin and associated names (see Annex I) 400 mg/57 mg/5 ml powder for oral suspension (mixed fruit flavour)}
Maltese: TAL-PRODOTT MEDIĊINALI Augmentin u ismijiet assoċjati miegħu (ara Anness I) trab għal suspensjoni orali ta' 400 mg/57 mg/5ml (togħma ta'frawli) [Ara Anness I - Biex timtela mill-pajjiż partikolari] Amoxicillin/clavulanic acid
English: 250 mg/25 mg powder for solution for injection or infusion Water for Injection Ph.Eur.
Maltese: Trab ta' 250 mg/25 mg għal soluzzjoni għall-injezzjoni jew għall-infużjoni Is-solvent normali huwa Ilma għall-Injezzjonijiet Ph.Eur.
English: 9 See section 4.4
Maltese: 9 Ara sezzjoni 4.4.
English: Augmentin 125 mg/62.5 mg/5 ml powder for oral suspension contains 2.5 mg of aspartame (E951) per ml, a source of phenylalanine.
Maltese: Trab għal suspensjoni orali ta' 125 mg/62.5 mg/5 ml Trab ta' Augmentin għal suspensjoni orali ta' 125 mg/62.5 mg/5 ml fih 2.5 mg ta' aspartame (E951) f'kull ml, li huwa sors ta' phenylalanine.
English: 6 These events have been noted with other penicillins and cephalosporins (see section 4.4).
Maltese: Dawn il-każijiet ġew innutati b'penicillins u cephalosporins oħra (ara sezzjoni 4.4).
English: ections ajor surgical
Maltese: TWISSIJA(IET) SPEĊJALI
English: • middle ear and sinus infections
Maltese: • infezzjonijiet tal-widna tan-nofs u tas-sinus
English: 500 mg/50 mg powder for solution for injection or infusion This medicinal product contains 9.8 mg (0.3 mmol) of potassium per per vial or bottle.
Maltese: Trab ta' 500 mg/50 mg għal soluzzjoni għall-injezzjoni jew għall-infużjoni Dan il-prodott mediċinali fih 9.8 mg (0.3 mmol) ta' potassum f'kull kunjett jew flixkun.
English: 500 mg/50 mg, 1000 mg/100 mg powder for solution for injection or infusion Powder for solution for injection or infusion.
Maltese: Trab ta' 500 mg/50 mg, 1000 mg/100 mg għal soluzzjoni għall-injezzjoni jew għall-infużjoni Trab għal soluzzjoni għall-injezzjoni jew għall-infużjoni.
English: The pharmacokinetic results for a study, in which amoxicillin/clavulanic acid (875 mg/125 mg tablets given twice daily) was administered in the fasting state to groups of healthy volunteers are presented below.
Maltese: Ir-riżultati farmakokinetiċi għal studju, li fih amoxicillin/clavulanic acid (pilloli ta' 875 mg/125 mg mogħtija darbtejn kuljum) kienu mogħtija fi stat ta' sawm lil gruppi ta' voluntiera b'saħħithom huma ppreżentati hawn taħt.
English: Add water in 2 portions up to the mark on the bottle label (60 ml) Add 74 ml of water (or add water in 2 portions up to the mark) (80 ml) Add 92 ml of water (or add water in 2 portions up to the mark) (100 ml) Invert and shake well
Maltese: Iċċekkja li s-siġill tat-tapp mhuwiex mimsus qabel ma tużah Żid ilma f'żewġ porzjonijiet sal-marka fuq it-tikketta tal-flixkun (60ml) Żid 74 ml ta' ilma (jew żid ilma f'żewġ porzjonijiet sal-marka) (80 ml) Żid 92 ml ta' ilma (jew żid ilma f'żewġ porzjonijiet sal-marka) (100 ml) Aqleb il-flixkun ta' taħt fuq u ħawwad sewwa
English: Antibiotic-associated colitis has been reported with nearly all antibacterial agents including amoxicillin and may range in severity from mild to life threatening (see section 4.8).
Maltese: Kolite assoċjata mal-antibijotiċi kienet irrappurtata bi kważi kull sustanza antibatterika inkluż amoxicillin u l-qawwa tagħha tista' tkun minn ħafifa sa ta' periklu għall-ħajja (ara sezzjoni 4.8).
English: Immune system disorders11 Angioneurotic oedema
Maltese: Disturbi fis-sistema immuni11 Edima anġjonewrotika
English: Nonclinical data reveal no special hazard for humans based on studies of safety pharmacology, genotoxicity and toxicity to reproduction.
Maltese: Informazzjoni mhux klinika, magħmula fuq studji konvenzjonali ta' sigurtà farmakoloġika, effett tossiku fuq il-ġeni u effett tossiku fuq is-sistema riproduttiva, ma turi l-ebda periklu speċjali għallbnedmin.
English: 250 mg/125 mg film-coated tablets entin in Clavamel weden - Spektramox
Maltese: Trab ta' 125 mg/31.25 mg fi qratas għal suspensjoni orali L-Isvezja - Spektramox
English: NAME OF THE MEDICINAL PRODUCT {Augmentin and associated names (see Annex I) 600 mg/42.9 mg/ 5 ml powder for oral suspension} [See Annex I - To be completed nationally]
Maltese: TAL-PRODOTT MEDIĊINALI Augmentin u ismijiet assoċjati miegħu (ara Anness I) trab għal suspensjoni orali ta' 600 mg/42.9 mg/5 ml [Ara Anness I - Biex timtela mill-pajjiż partikolari] Amoxicillin/clavulanic acid
English: Serious skin reactions: eyes and genitals (Stevens-Johnson syndrome), and a more severe form, causing extensive peeling of the skin (more than 30% of the body surface - toxic epidermal rash with small pus-containing blisters (bullous exfoliative dermatitis)
Maltese: R zzjonijiet serji fil-ġilda: - raxx mifrux bl-infafet u ġilda titqaxxar, b'mod partikolari madwar il-ħalq, l-imnieħer, lgħajnejn u l-ġenitali (sindrome ta' Stevens-Johnson), u forma aktar qawwija, li tikkawża tqaxxir estensiv tal-ġilda (aktar minn 30% tas-superfiċje tal-ġisem - nekroliżi epidermali tossika)
English: 875 mg/125 mg, 400 mg/57 mg powder for oral suspension in sachets The contents of the single-dose sachet are to be dispersed in half a glass of water before ingestion.
Maltese: Trab ta' 875 mg/125 mg, 400 mg/57 mg fi qratas għal suspensjoni orali Il-kontenut tal-qartas għal doża waħda għandu jixtered ġo nofs tazza ilma qabel ma jittieħed.
English: Intermediate
Maltese: Intermedju
English: • You may be provided with a plastic measuring spoon or measuring cup.
Maltese: • Jista' jkun li tingħatalek mgħarfa tal-plastik biex tkejjel jew tazza tal-plastik biex tkejjel.
English: Augmentin and associated names (see Annex I) 1000 mg/125 mg powder for oral suspension [See Annex I - To be completed nationally]
Maltese: Augmentin u ismijiet assoċjati miegħu (ara Anness I) trab ta' 1000 mg/125 mg għal suspensjoni orali [Ara Anness I - Biex timtela mill-pajjiż partikolari] Amoxicillin/clavulanic acid
English: 3 Breakpoint values in the table are based on Ampicillin breakpoints.
Maltese: 3 Il-valuri tal-breakpoints fit-tabella huma bbażati fuq il-breakpoints ta' Ampicillin.
English: Augmentin and associated names (see Annex I) 600 mg/42.9 mg/5 ml powder for oral suspension [See Annex I - To be completed nationally]
Maltese: {Augmentin u ismijiet assoċjati miegħu (ara Anness I) trab għal suspensjoni orali ta' 600 mg/42.9 mg/5 ml} [Ara Anness I - Biex timtela mill-pajjiż partikolari]
English: 500 mg/50 mg powder for solution for injection or infusion Water for Injection Ph.Eur.
Maltese: Trab ta' 500 mg/50 mg għal soluzzjoni għall-injezzjoni jew għall-infużjoni Is-solvent normali huwa Ilma għall-Injezzjonijiet Ph.Eur.
English: Hungary- Augmentin
Maltese: L-Ungerija- Augmentin
English: Amoxicillin and clavulanic acid serum concentrations achieved with amoxicillin/clavulanic acid are similar to those produced by the oral administration of equivalent doses of amoxicillin or clavulanic acid alone.
Maltese: It-tneħħija totali ta' amoxicillin/clavulanic acid mis-serum tonqos b'mod proporzjonali ma' tnaqqis filfunzjoni tal-kliewi.
English: The major route of elimination for amoxicillin is via the kidney, whereas for clavulanic acid it is by both renal and non-renal mechanisms.
Maltese: Ir-rotta prinċipali ta' eliminazzjoni għal amoxicillin hija permezz tal-kilwa, filwaqt li għal clavulanic acid hija kemm b'mekkaniżmi renali kif ukoll mhux renali.
English: • are being treated for liver or kidney problems are not passing water regularly.
Maltese: • Jekk ibnek/bintek għandu/ha problemi fil-kliewi d-doża jista' jkun li titnaqqas.
English: Lithuania - Augmentin
Maltese: Il-Litwanja - Augmentin
English: PACKAGE LEAFLET
Maltese: uti tal-pakkett
English: Hungary - Augmentin
Maltese: L-Ungerija - Augmentin
English: Augmentin powder for oral suspension contains maltodextrin (glucose).
Maltese: Trab għal suspensjoni orali ta' Augmentin fih maltodextrin (glucose).
English: Hypersensitivity vasculitis
Maltese: Vaskulite ta' sensittività eċċessiva
English: 125 mg/62.5 mg/5 ml powder for oral suspension
Maltese: Trab għal suspensjoni orali ta' 125 mg/62.5 mg/5 ml Dijarea
English: Slovak Republic - Augmentin
Maltese: Is-Slovakkja - Augmentin
English: Augmentin and associated names (see Annex I) 400 mg/57 mg/5 ml powder for oral suspension (strawberry flavour) [See Annex I - To be completed nationally]
Maltese: Augmentin u ismijiet assoċjati miegħu (ara Anness I) trab ta' 400 mg/57 mg għal suspensjoni orali [Ara Anness I - Biex timtela mill-pajjiż partikolari] Amoxicillin/clavulanic acid
English: Amoxicillin/clavulanic acid should only be used during breast-feeding after benefit/risk assessment by the physician in charge.
Maltese: Amoxicillin/clavulanic acid għandu jintuża biss waqt it-treddigħ wara li ssir stima ta' benefiċċju/riskju mit-tabib responsabbli.
English: Augmentin and associated names (see Annex I) 2000 mg/200 mg powder for solution for infusion [See Annex I - To be completed nationally]
Maltese: Augmentin u ismijiet assoċjati miegħu (ara Anness I) trab ta' 2000 mg/200 mg għal soluzzjoni għallinfużjoni [Ara Anness I - Biex timtela mill-pajjiż partikolari] Amoxicillin/clavulanic acid
English: Skin and subcutaneous tissue disorders 7 Skin rash
Maltese: Disturbi fil-ġilda u fit-tessuti ta' taħt il-ġilda 7 Raxx fil-ġilda
English: 125 mg/62.5 mg/5 ml powder for oral suspension 11 Superficial tooth discolouration has been reported very rarely in children.
Maltese: Trab għal suspensjoni orali ta' 125 mg/62.5 mg/5 ml 11 Telf ta' kulur superfiċjali tas-snien kien irrappuratat b'mod rari ħafna fit-tfal.
English: • convulsions (in pe show u
Maltese: • aċċessjonijie fil-kliewi)
English: This presentation should not be used to treat penicillin-resistant S. pneumoniae.
Maltese: Din il-preżentazzjoni tista' ma tkunx adattata għall-kura ta' S. pneumoniae reżistenti għal penicillin.
English: • low number of cells involved in bl
Maltese: • numru baxx ta' ċelluli involuti fit-tgħaqqi
English: Reversible agranulocytosis
Maltese: 4.1 Indikazzjonijiet terapewtiċi
English: ugmentin
Maltese: Anafilassi
English: Augmentin and associated names (see Annex I) 125 mg/31.25 mg/5 ml powder for oral suspension [See Annex I - To be completed nationally]
Maltese: Augmentin u ismijiet assoċjati miegħu (ara Anness I) trab ta' 125 mg/31.25 mg għal suspensjoni orali [Ara Anness I - Biex timtela mill-pajjiż partikolari] Amoxicillin/clavulanic acid
English: Augmentin and associated names (see Annex I) 250 mg/62.5 mg/5 ml powder for oral suspension [See Annex I - To be completed nationally]
Maltese: Augmentin u ismijiet assoċjati miegħu (ara Anness I) trab ta' 250 mg/62.5 mg għal suspensjoni orali [Ara Anness I - Biex timtela mill-pajjiż partikolari] Amoxicillin/clavulanic acid
English: 6 July 2012
Maltese: 6 ta' Lulju 2012
English: 1 Yaz is authorised in all EU Member States except Hungary, and Ethinylestradiol-Drospirenone 24+4 is authorised in the following Member States: Austria, Bulgaria, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Italy, Malta, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, and the United Kingdom.
Maltese: 1 Yaz huwa awtorizzat fl-Istati Membri kollha tal-UE ħlief fl-Ungerija, u Ethinylestradiol-Drospirenone 24+4 huwa awtorizzat fl-Istati Membri li ġejjin: l-Awstrija, il-Bulgarija, Ċipru, ir-Repubblika Ċeka, id-Danimarka, il-Finlandja, Franza, il-Ġermanja, il-Greċja, l-Italja, Malta, il-Polonja, il-Portugall, is-Slovakkja, is-Slovenja, Spanja, l-Isvezja, u r-Renju Unit.
English: They contain two active substances, ethinylestradiol and drospirenone, which are derived from natural hormones produced in the ovaries: ethinylestradiol is derived from oestrogen and drospirenone is derived from progesterone.
Maltese: Fihom żewġ sustanzi attivi, ethinylestradiol u drospirenone, li ġejjin minn ormoni naturali prodotti fl-ovarji: ethinylestradiol huwa derivat mill-estroġenu u drospirenone huwa derivat mill-proġesteron.
English: Questions and answers on Yaz 24+4 and Ethinylestradiol-Drospirenone 24+4 (ethinylestradiol / drospirenone, 0.02 mg/3 mg tablets) EMA/550781/2012
Maltese: (ethinylestradiol / drospirenone, 0.02 mg/3 mg pilloli) EMA/257547/2012
English: Yaz 24+4 and Ethinylestradiol-Drospirenone 24+4 are combined contraceptive pills.
Maltese: Yaz 24+4 u Ethinylestradiol-Drospirenone 24+4 huma pilloli kontraċettivi kkombinati.
English: Questions and answers on Yaz 24+4 and EthinylestradiolDrospirenone 24+4 (ethinylestradiol / drospirenone, 0.02 mg/3 mg tablets)
Maltese: Drospirenone 24+4 (ethinylestradiol / drospirenone, 0.02 mg/3 mg pilloli)
English: What are Yaz 24+4 and Ethinylestradiol-Drospirenone 24+4?
Maltese: Yaz 24+4 u Ethinylestradiol-Drospirenone 24+4?
English: The European Commission issued the decisions on 3 July 2012 (Yaz 24+4) and 6 July 2012 (Ethinylestradiol-Drospirenone 24+4).
Maltese: Il-Kummissjoni Ewropea ħarġet id-deċiżjonijiet fit-3 ta' Lulju 2012 (Yaz 24+4) u fis-6 ta' Lulju 2012 (Ethinylestradiol-Drospirenone 24+4).
English: The company that markets Yaz 24+4 and Ethinylestradiol-Drospirenone 24+4 is Bayer B.V.
Maltese: Il-kumpanija li tqiegħed Yaz 24+4 u Ethinylestradiol-Drospirenone 24+4 fis-suq hija Bayer B.V.
English: Yaz 24+4 and Ethinylestradiol-Drospirenone 24+4 are authorised in several Member States of the European Union (EU)1 under a mutual recognition procedure on the basis of an initial authorisation granted by the Netherlands.
Maltese: Yaz 24+4 u Ethinylestradiol-Drospirenone 24+4 huma awtorizzati f'bosta Stati Membri tal-Unjoni Ewropea (UE)1 taħt proċedura ta' rikonoxximent reċiproku abbażi ta' awtorizzazzjoni inizjali mogħtija mill-Pajjiżi l-Baxxi.
English: The company applied for a change to the marketing authorisations of these medicines to extend their use to include the ‘treatment of moderate acne vulgaris only in women seeking oral contraception'.
Maltese: Il-kumpanija applikat għal tibdil fl-awtorizzazzjonijiet għat-tqegħid fis-suq ta' dawn il-mediċini biex testendi l-użu tagħhom biex jinkludi l-‘kura ta' akne vulgaris moderata biss f'nisa li qegħdin ifittxu kontraċettiv orali'.
English: On 19 April 2012, the European Medicines Agency completed an arbitration procedure for Yaz 24+4 and Ethinylestradiol-Drospirenone 24+4.
Maltese: Fid-19 ta' April 2012, l-Aġenzija Ewropea għall-Mediċini temmet proċedura ta' arbitraġġ għal Yaz 24+4 u Ethinylestradiol-Drospirenone 24+4.
English: The Committee also considered the known risks with Yaz 24+4 and Ethinylestradiol-Drospirenone 24+4, including VTE.
Maltese: Il-Kumitat ikkunsidra wkoll r-riskji magħrufa b'Yaz 24+4 u b'Ethinylestradiol-Drospirenone 24+4, inkluż il-VTE.
English: Yaz 24+4 and Ethinylestradiol-Drospirenone 24+4 work by changing the body's hormonal balance to prevent ovulation, by altering the mucus in the cervix (neck of the womb) and by thinning the endometrium (the lining of the womb).
Maltese: Yaz 24+4 u Ethinylestradiol-Drospirenone 24+4 jaħdmu billi jbiddlu l-bilanċ ormonali tal-ġisem biex jipprevjenu lovulazzjoni, billi jbiddlu l-mukus fiċ-ċerviċi (l-għonq tal-utru) u billi jraqqu l-endometriju (il-kisi talġuf).
English: Women not seeking contraception would therefore be unnecessarily exposed to the risks of Yaz 24+4 and Ethinylestradiol-Drospirenone 24+4 when alternative acne treatments are available.
Maltese: Nisa li ma kinux qegħdin ifittxu kontraċettiv għalhekk sejrin ikunu esposti bla bżonn għar-riskji ta' Yaz 24+4 u ta' EthinylestradiolDrospirenone 24+4 meta kura alternattiva għall-akne hija disponibbli.
English: The CHMP noted the overall effectiveness of Yaz 24+4 and Ethinylestradiol-Drospirenone 24+4 compared with placebo in the treatment of acne.
Maltese: Is-CHMP innota l-effikaċja ġenerali ta' Yaz 24+4 u ta' Ethinylestradiol-Drospirenone 24+4 meta mqabbla ma' plaċebo fil-kura tal-akne.
English: concerned Member States.
Maltese: kkonċernati kollha.
English: Product information
Maltese: Anness
English: This product information is the outcome of the referral procedure to which this Commission decision relates.
Maltese: Din l-informazzjoni tal-prodott hi r-riżultat tal-proċedura ta' riferiment li għaliha tapplika din iddeċiżjoni tal-Kummissjoni.
English: The valid product information is the final version achieved during the Coordination group procedure.
Maltese: It-tagħrif validu dwar dan il-prodott hu l-verżjoni finali li ġiet miksuba matul il-proċedura tal-grupp ta' Koordinazzjoni
English: Annex III Product information
Maltese: III
English: EU/1/02/223/001 EU/1/02/223/002
Maltese: EU/1/02/223/001 EU/1/02/223/002 EU/1/02/223/003
English: VTE may be fatal in 1-2% of cases.
Maltese: VTE jista' jkun fatal f'1-2% tal-każijiet.
English: Clinical efficacy and safety Pearl Indices (see table):
Maltese: Effikaċja klinika u sigurtà Indiċi Pearl (ara t-tabella):
English: Medical examination/consultation
Maltese: Eżami mediku/konsultazzjoni
English: Date of latest renewal: 22 August 2012.
Maltese: Data tal-aħħar tiġdid: 22 ta' Awissu 2012.
English: Pearl Index (95% CI)
Maltese: Indiċi Pearl Falliment talMetodu (95% CI)
English: IS-210 Garðabær Simi: (+354) 535 7000
Maltese: Garðabær Simi: (+354) 535 7000
English: Vorgartenstraße 206B A-1020 Wien
Maltese: Vorgartenstraße 206B
English: Slovenská republika Janssen, Johnson & Johnson, s.r.o.
Maltese: Slovenská republika Janssen, Johnson & Johnson, s.r.o. CBC
English: • You weigh 90 kg (which is 14 stone 2 lb) or more;
Maltese: • Tiżen 90 kg (li huwa 14 stone 2lb) jew iżjed;
English: † See section 4.4.
Maltese: Ara sezzjoni 4.4.
English: Number of VTE events
Maltese: Numru ta' avvenimenti
English: oxcarbazepine, and felbamate)
Maltese: primidone, oxcarbazepine, u felbamate)
English: Pearl Index (95% CI) * DSG 150 mcg + 20 mcg EE ** 50 mcg LNG + 30 mcg for days 1 - 6, 75 mcg LNG + 40 mcg EE for days 7 - 11, 125 mcg LNG + 30 mcg EE for 12
Maltese: * DSG 150 mcg + 20 mcg EE ** 50 mcg LNG + 30 mcg għall-ġranet 1 - 6, 75 mcg LNG + 40 mcg EE għall-ġranet 7 - 11, 125 mcg LNG + 30 mcg EE
English: CONT-004 COC**
Maltese: KONT-004 COC**
English: Erythema rare
Maltese: Eritema rari
English: Secondary packaging material
Maltese: Materjal tal-pakkett sekondarju
English: in a lung (i.e. PE)
Maltese: fil-pulmun (i.e. PE)
English: CONT-003 COC*
Maltese: KONT-003 COC*
English: Table 1: Frequency of adverse reactions System Organ Class
Maltese: Tabella 1: Frekwenza ta' reazzjonijiet avversi
English: Frequency MedDRA convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the available data).
Maltese: Konvenzjoni MedDRA fuq il-frekwenzi: komuni ħafna (≥ 1/10); komuni (≥ 1/100 sa < 1/10); mhux komuni (≥ 1/1,000 sa < 1/100); rari (≥ 1/10,000 sa < 1/1,000); rari ħafna (<1/10,000; mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: Effects of other medicinal products on EVRA
Maltese: Effetti ta' prodotti mediċinali oħra fuq EVRA
English: EVRA is intended for women of fertile age.
Maltese: EVRA hija intenzjonata għan-nisa ta' età fertili.
English: Norelgestromin and norgestrel (a serum metabolite of norelgestromin) are highly bound (> 97%) to serum proteins.
Maltese: Norelgestromin u norgestrel (is-sustanza fis-serum iffurmata minn norelgestromin) jeħlu ħafna (>97%) mal-proteini tas-serum.
English: Mid-point of range of 5-7 per 10,000 WY, based on a relative risk for CHCs containing levonorgestrel versus non-use of approximately 2.3 to 3.6
Maltese: In-nofs ta' medda ta' 5-7 minn kull 10,000 WY, ibbażat fuq riskju relattiv għal CHCs li fihom levonorgestrel kontra nuqqas ta' użu ta' madwar 2.3 sa 3.6
English: • You have or have had ‘pregnancy spots'.
Maltese: • Għandek jew qatt kellek ponot tat-tqala ‘pregnancy spots'.
English: Inhibition of ethinyl estradiol metabolism
Maltese: Inibizzjoni tal-metaboliżmu ta' ethinyl estradiol
English: Primary packaging material
Maltese: Materjal tal-pakkett primarju
English: • anti-seizure medicines (such as barbiturates, topiramate, phenytoin, carbamazepine, primidone,
Maltese: • mediċini kontra l-aċċessjonijiet (bħal barbiturates, topiramate, phenytoin, carbamazepine,
English: Frustration* Libido increased
Maltese: Frustrazzjoni* Żieda fil-libido
English: CONT-002 EVRA
Maltese: KONT-002 EVRA
English: Erythema (multiforme, nodosum)* Chloasma†
Maltese: Eritema (multiforme nodosum)* Kloasma†
English: Arterial thromboembolism (Acute) myocardial infarction*†
Maltese: Tromboemboliżmu fl-arterji Infart mijokardijaku (akut)*†
English: • chest pain, discomfort, pressure, heaviness;
Maltese: • uġigħ fis-sider, skonfort, pressjoni, toqol;
English: Arterial thromboembolic events may be fatal.
Maltese: Avvenimenti tromboembolitiċi arterjali jistgħu jkunu fatali.
English: Colitis*
Maltese: Kolite*
English: Particularly important in women with additional risk factors.
Maltese: Partikularment importanti f'nisa fatturi addizzjonali ta' riskju.
English: • medicines containing ciclosporin
Maltese: • mediċini li fihom ciclosporin
English: • Concomitant use with the medicinal products containing ombitasvir/paritaprevir/ritonavir and dasabuvir (see sections 4.4 and 4.5).
Maltese: • Użu flimkien ma' prodotti mediċinali li fihom ombitasvir/paritaprevir/ritonavir u dasabuvir (ara sezzjonijiet 4.4 u 4.5).
English: • medicines for infection (such as rifampicin and griseofulvin)
Maltese: • mediċini għall-infezzjoni (bħal rifampicin u griseofulvin)
English: • Problems sleeping (insomnia)
Maltese: • Problemi fl-irqad (insomnja)
English: This corresponds to between about 6 and 12 VTEs in a year out of 10,000 women who use EVRA.
Maltese: Dan jikkorrispondi għal bejn madwar 6 u 12 VTEs f'sena minn 10,000 mara li jużaw EVRA.
English: deficiency, protein S deficiency, antithrombin-III deficiency, Factor V Leiden or antiphospholipid antibodies;
Maltese: proteina Ċ, defiċjenza ta' proteina S, defiċjenza ta' antithrombin-III, antikorpi ta' Fattur V
English: • Major surgery with prolonged immobilisation (see section 4.4);
Maltese: • Operazzjoni maġġuri b'immobilizzazzjoni fit-tul (ara sezzjoni 4.4)
English: • Weeks 1, 2 & 3: Put on one patch and leave it on for exactly seven days.
Maltese: • Ġimgħa 1, 2 u 3: Poġġi garża waħda u ħalliha mwaħħla għal eżattament sebat ijiem.
English: CONT-003 EVRA
Maltese: KONT-003 EVRA
English: B-2340 Beerse, Belgium
Maltese: B-2340 Beerse, Il-Belġju
English: Manufacturer: Janssen Pharmaceutica NV, Turnhoutseweg 30, B-2340 Beerse, Belgium.
Maltese: Janssen Pharmaceutica NV, Turnhoutseweg 30, B-2340 Beerse, Il-Belġju.
English: Insomnia Libido decreased rare
Maltese: Insomnja Tnaqqis fil-libido rari
English: The most commonly reported adverse reactions in clinical trials were headache, nausea, and breast tenderness, occurring in approximately 21.0%, 16.6%, and 15.9% of patients, respectively.
Maltese: L-aktar reazzjonijiet avversi rrapportati fi provi kliniċi kienu uġigħ ta' ras, dardir u sensibilità fis-sider, li seħħew f'bejn wieħed u ieħor 21.0%, 16.
English: Ethinyl estradiol is also metabolised to various hydroxylated products and their glucuronide and sulfate conjugates.
Maltese: Ethinyl estradiol jiġi wkoll immetabolizzat fi prodotti varji idroksilati u l-konjugi glukuronide u sulfati tagħhom.
English: Dermatitis allergic Eczema
Maltese: Dermatite allerġika Ekżema
English: Increasing age
Maltese: Żieda fl-età
English: Risk of arterial thromboembolism (ATE)
Maltese: Riskju ta' tromboemboliżmu arterjali (ATE)
English: EU/1/02/223/001: 3 transdermal patches EU/1/02/223/002: 9 transdermal patches EU/1/02/223/003: 18 transdermal patches
Maltese: EU/1/02/223/001: 3 gareż li jipprovdu mediċina li tgħaddi minn ġol-ġilda EU/1/02/223/002: 9 gareż li jipprovdu mediċina li tgħaddi minn ġol-ġilda EU/1/02/223/003: 18-il garża li jipprovdu mediċina li tgħaddi minn ġol-ġilda
English: Thrombosis*†
Maltese: Trombożi*†
English: Hyperglycaemia* Insulin resistance*
Maltese: Ipergliċemija* Reżistenza għall-insulina*