FrancophonIA/ELRC3.0 huggingface dataset:
English: Ritonavir dosed as a pharmacokinetic enhancer or as an antiretroviral agent inhibits CYP3A4 and as a result is expected to increase the plasma concentrations of carbamazepine.
Maltese: Ritonavir f'doża biex iżid l-effett farmakokinetiku jew bħala aġent antiretrovirali jimpedixxi CYP3A4, u għalhekk huwa mistenni li jżid ilkonċentrazzjoni fil-plażma ta' carbamazepine.
English: Didanosine 200 q12h
Maltese: 200 qd 100 q12h
English: Maximal inhibition of metabolism of the co-administered protease inhibitor is generally achieved with ritonavir doses of 100 mg daily to 200 mg twice daily, and is dependent on the co-administered protease inhibitor.
Maltese: L-impediment massimali tal-metaboliżmu tal-impeditur protejaż li jingħata ma' ritonavir ġeneralment jintlaħaq b'dożi ta' ritonavir ta' minn 100 mg kuljum sa 200 mg darbtejn kuljum, u dan jiddependi fuq l-impeditur protejaż li jingħata ma' ritonavir.
English: 200 q12h Tipranavir
Maltese: 200 q12h/1h qabel
English: Life-threatening and fatal drug interactions have been reported in patients treated with colchicine and strong inhibitors of CYP3A like ritonavir (see sections 4.3 and 4.5).
Maltese: Ġew irrappurtati interazzjonijiet, ma' prodotti mediċinali oħra, li jistgħu jipperikolaw il-ħajja u oħrajn fatali, f'pazjenti ttrattati b'colchicine u inibituri qawwija ta' CYP3A bħal ritonavir (ara sezzjonijiet 4.3 u 4.5).
English: Very common Dysgeusia, oral and peripheral paraesthesia, headache, dizziness, peripheral neuropathy
Maltese: Komuni ħafna Disġewżja, parasteżija periferali u madwar ilħalq, uġigħ ta' ras, sturdament, newropatija periferali
English: Place empty sachet in rubbish.
Maltese: Dan se jmexxi kwalunkwe bżieżaq sal-ponta.
English: Anti-gout treatments
Maltese: GĦAMLA FARMAĊEWTIKA
English: Adverse reactions from clinical trials and post-marketing experience in adult patients The most frequently reported adverse drug reactions among patients receiving ritonavir alone or in combination with other antiretroviral drugs were gastrointestinal (including diarrhea, nausea, vomiting, abdominal pain (upper and lower)), neurological disturbances (including paresthesia and oral paresthesia) and fatigue/asthenia.
Maltese: L-aktar reazzjonijiet avversi tal-mediċina rrapurtati b'mod frekwenti fost pazjenti li qed jirċievu ritonavir biss jew ritonavir flimkien ma' mediċini antiretrovirali oħra kienu disturbi gastrointestinali (li jinkludu dijarea, nawseja, rimettar, uġigħ addominali (fil-parti ta' fuq u fil-parti t'isfel)), disturbi newroloġiċi (li jinkludu parasteżija u parasteżija madwar il-ħalq) u għeja/astenja.
English: − Muscle pain, tenderness or weakness, particularly in combination with antiretroviral therapy including protease inhibitors and nucleoside analogues.
Maltese: - Uġigħ fil-muskoli, sensittivita jew dgħjufija, speċjalment jekk int qiegħed tieħu Norvir flimkien ma' terapija antiretrovirali li tinkludi impedituri protejaż u analogi ta' nukleòside.
English: − if you are allergic to ritonavir or any of the other ingredients of Norvir (see section 6).
Maltese: - jekk inti allerġiku għal ritonavir jew sustanzi oħra ta' Norvir (ara sezzjoni 6).
English: More frequent electrocardiogram monitoring and monitoring of transaminases is recommended (see section 4.4 and refer to the bedaquiline Summary of Product Characteristics).
Maltese: Monitoraġġ aktar frekwenti b'elettrokardjogramma u l-monitoraġġ ta' transaminases huwa rrakkomandat (ara sezzjoni 4.4 u rreferi għas-Sommarju tal-Karatteristiċi tal-Prodott ta' bedaquiline).
English: Consequently, concomitant administration of ritonavir dosed as an antiretroviral agent or as a pharmacokinetic enhancer and these glucocorticoids is not recommended unless the potential benefit of treatment outweighs the risk of systemic corticosteroid effects (see section 4.4).
Maltese: Effett fuq ilprodott mediċinali li jittieħed ma' ritonavir Cmax jekk il-benefiċju potenzjali li jista' jkollu t-trattament ikun jiżboq ir-riskju tal-effetti tal-corticosteroids sistematiċi (ara sezzjoni 4.4).
English: Common Hypersensitivity including urticaria, and face oedema
Maltese: Sensittività eċċessiva, li tinkludi urtikarja u edima fil-wiċċ
English: AbbVie Logistics B.V., Zuiderzeelaan 53, 8017 JV Zwolle, The Netherlands The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.
Maltese: AbbVie Logistics B.V., Zuiderzeelaan 53, 8017 JV Zwolle, The Netherlands
English: ↑ 16-fold
Maltese: Waqfien mit-tipjip
English: Saquinavir/ritonavir should not be given together with rifampicin, due to the risk of severe hepatotoxicity (presenting as increased hepatic transaminases) if the three medicines are given together (see section 4.5).
Maltese: Saquinavir/ritonavir m'għandux jingħata flimkien ma' rifampicin minħabba r-riskju ta' tossiċità severa fil-fwied (li timmanifesta ruħha permezz ta' żieda fit-transaminases tal-fwied) jekk dawn it-tliet mediċini jingħataw flimkien (ara sezzjoni 4.5).
English: − Multipacks comprising 3 bottles each containing 30 film-coated tablets (90 tablets)
Maltese: - Flixkun ta' 30 pillola - Flixkun ta' 60 pillola - Pakkett li fih 3 fliexken ta' 30 pillola miksija b'rita kull wieħed (90 pillola).
English: − The active substance is ritonavir.
Maltese: X'fih Norvir - Is-sustanza attiva hi ritonavir.
English: Delavirdine 400 q8h
Maltese: 400 q8h
English: Cmax (µg/ml) Ctrough (µg/ml) 0.08 ± 0.04
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/96/016/005-007
English: Decreased R-warfarin levels may lead to reduced anticoagulation, therefore it is recommended that anticoagulation parameters are monitored when warfarin is co-administered with ritonavir dosed as an antiretroviral agent or as a pharmacokinetic enhancer.
Maltese: Livelli mnaqqsa ta' Rwarfarin jistgħu jwasslu għal tnaqqis fil-koagulazzjoni, għalhekk huwa rrakkomandat li meta warfarin jittieħed flimkien ma' ritonavir mogħti f'doża bħala aġent antiretrovirali jew biex iżid l-effett farmakokinetiku, jiġu monitorjati il-parametri ta' kontra l-koagulazzjoni.
English: The concomitant administration with ranolazine is contraindicated (see section 4.3).
Maltese: L-għoti flimkien ta' Kaletra u ranolazine huwa kontraindikat (ara sezzjoni 4.3).
English: Animal data have shown reproductive toxicity (see section 5.3).
Maltese: Informazzjoni fuq l-annimali uriet tossiċita riproduttiva (ara 5.3). Norvir jista' jintuża waqt it-tqala jekk ikun meħtieġ klinikament.
English: Since increased concentrations of lovastatin and simvastatin may predispose patients to myopathies, including rhabdomyolysis, the combination of these medicinal products with ritonavir is contraindicated (see section 4.3).
Maltese: Peressi li żieda fil-konċentrazzjoni ta' lovastatin u simvastatin tista' tippredisponi lill-pazjenti għall-mijopatija, li jinkludi rabdomijoli, l-għotja ta' dawn il-prodotti mediċinali flimkien ma' ritonavir hija kontro-indikata (ara sezzjoni 4.3).
English: MM/YYYY
Maltese: • ħakk
English: Concomitant use of vardenafil with ritonavir is contraindicated (see section 4.3).
Maltese: L-użu flimkien ta' vardenafil ma' ritonavir huwa kontra-indikat (ara sezzjoni 4.3).
English: 6.5 Nature and contents of container
Maltese: 6.1 Lista ta' eċċipjenti Copovidone
English: If the benefit is considered to outweigh the risk and ritonavir must be used, reduce the ibrutinib dose to 140 mg and monitor patient closely for toxicity.
Maltese: Jekk il-benefiċċju huwa meqjus li huwa akbar mir-riskju u ritonavir għandu jintuża, tnaqqas id-doża ta 'ibrutinib għal 140 mg u tissorvelja mill-qrib il-pazjent għal tossiċità.
English: Pour ALL powder from sachet onto food (see Figure 4).
Maltese: Il-porzjon KOLLU għandu jittiekel (ara Figura 6).
English: For selected medicinal products (e.g. alprazolam) the inhibitory effects of ritonavir on CYP3A4 may decrease over time.
Maltese: Għal xi prodotti mediċinali partikolari (e.ż. alprazolam) l-effetti ta' impediment ta' ritonavir fuq CYP3A4 jistgħu jonqsu maż-żmien.
English: How do I take the correct dose of Norvir powder for oral suspension mixed with liquid?
Maltese: Kif għandi nieħu d-doża korretta ta' trab għal suspensjoni orali Norvir mħallat mal-likwidu?
English: Co-administration with Norvir may cause a large increase in the concentration of this benzodiazepine.
Maltese: L-għoti tiegħu flimkien ma' Norvir jista' jikkaġuna żieda kbira fil-konċentrazzjoni ta' dan il-benzodiazepine.
English: Norvir should be started at 250 mg/m² and increased at 2 to 3 day intervals by 50 mg/m² twice daily.
Maltese: Norvir għandu jibda jittieħed b'doża ta' 250 mg/m² u jiżdied kull jumejn jew tlieta b'50 mg/m² darbtejn kuljum.
English: There have been reports of muscle pain, tenderness or weakness, particularly when taking medicines to lower cholesterol in combination with antiretroviral therapy, including protease inhibitors and nucleoside analogues.
Maltese: Kien hemm rapporti ta' uġigħ fil-muskoli, sensittivita jew dgħjufija, partikolarment meta jkunu qegħdin jittieħdu prodotti mediċinali biex jitbaxxa l-livell tal-kolosterol, flimkien ma' terapija antiretrovirali, inklużi impedituri protejaż u analogi nuklèoside.
English: Refer to the ceritinib SmPC for dosage adjustment recommendations.
Maltese: Għandhom jiġu kkonsultati l-SmPCs individwali.
English: d. Let the liquid stand for 10 minutes and most of the bubbles will disappear.
Maltese: d. Ħalli l-likwidu joqgħod għal 10 minuti u ħafna mill-bżieżaq se jisparixxu.
English: 20, single dose
Maltese: 20, doża waħda
English: Increased plasma concentrations of ergot derivatives leading to acute ergot toxicity, including vasospasm and ischaemia.
Maltese: Żieda fil-konċentrazzjoni fil-plażma ta' derivattivi tal-ergotina li twassal għal tossiċita akuta tal-ergotina, li tinkludi għeluq tal-vini u iskemija.
English: 300 mg in the morning and 300 mg in the evening
Maltese: 300 mg filgħodu u 300 mg filgħaxija
English: Ritonavir dosed as a pharmacokinetic enhancer or as an antiretroviral agent inhibits CYP3A and as a result is expected to increase the plasma concentrations of loratadine.
Maltese: Ritonavir dożat biex iżid l-effett farmakokinetiku jew bħala aġent antiretrovirali jimpedixxi s-CYP3A u għalhekk huwa mistenni li jżid ilkonċentrazzjoni fil-plażma ta' loratadine.
English: Ritonavir inhibits CYP3A-mediated metabolism of ketoconazole.
Maltese: jistgħu jirriżultaw effetti simili b'corticosteroids oħra metabolati b' CYP3A e.ż.,budesonide u triamcinolone.
English: Maximum PR interval was 252 msec and no second or third degree heart block was observed (see section 4.4).
Maltese: L-intervall PR massimu kien ta' 252 msec u ma ġie osservat l-ebda imblukkar tal-qalb tat-tieni jew tat-tielet grad (ara sezzjoni 4.4).
English: Concomitant use of ritonavir and fluticasone or other glucocorticoids that are metabolised by CYP3A4 is not recommended unless the potential benefit of treatment outweighs the risk of systemic corticosteroid effects, including Cushing's syndrome and adrenal suppression (see section 4.5).
Maltese: L-użu flimkien ta' ritonavir u fluticasone jew glucocorticoids oħra li jiġu metabolizzati minn CYP3A4 m'huwiex rakkommandat, ħlief jekk il-benefiċji potenzjali tat-trattament huma akbar mir-riskju ta' effetti sistemiċi tal-corticosteroid, li jinkludu is-sindromu Cushing (Cushing's Syndrome) u soppressjoni adrenali (ara sezzjoni 4.5).
English: When ritonavir is used as a pharmacokinetic enhancer of other PIs, consult the Summary of Product Characteristics of the co-administered protease inhibitor for contraindications.
Maltese: Meta ritonavir jiġi użat ma impedituri tal-protejaż oħra biex iżid l-effett farmakokinetiku, għandu jiġi kkonsultat is-sommarju tal-karatteristiċi tal-impeditur tal-protejaż partikolari .
English: Tissue to plasma ratios of approximately 1 measured in rat lymph nodes suggests that ritonavir distributes into lymphatic tissues.
Maltese: Matul it-terapija kontra l-HIV jista' jkun hemm żieda fil-piż u fil-livelli ta' lipidi u glukożju fid-demm.
English: Serum concentrations may be increased when co-administered with ritonavir which may increase the risk of toxicity, including the risk of serious adverse events such as QT interval prolongation.
Maltese: Il-konċentrazzjonijiet fis-serum jistgħu jiżdiedu meta jingħataw flimkien ma' ritonavir li jistgħu jżidu ir-riskju ta' tossiċità, inkluż ir-riskju ta' avvenimenti avversi serji bħal titwil tal-intervall tal-QT.
English: Nevirapine 200 q12h
Maltese: 20, doża waħda 200 q12h
English: Norvir is also supplied as a film-coated tablet containing 100 mg ritonavir.
Maltese: Norvir huwa fornut ukoll bħala bħala bħala pillola miksija b'rita li fiha 100 mg ritonavir.
English: Each sachet of Norvir contains 100 mg ritonavir.
Maltese: Kull qartas ta' Norvir fih 100 mg ritonavir.
English: Human experience of acute overdose with ritonavir is limited.
Maltese: L-esperjenza ta' doża eċċessiva akuta b'ritonavir fil-bniedem hija limitata.
English: Treatment should be initiated at 300 mg (three sachets) twice daily for a period of three days and increased by 100 mg (one sachet) twice daily increments up to 600 mg twice daily over a period of no longer than 14 days.
Maltese: It-trattament għandu jinbeda bi 300 mg (3 pilloli) darbtejn kuljum għal perijodu ta' tlett ijiem, u jiżdied b'100 mg (pillola waħda) darbtejn kuljum sakemm wieħed jasal sa 600 mg darbtejn kuljum, u dana fuq perijodu ta' mhux akatr minn 14 il- ġurnata.
English: Careful monitoring of therapeutic and adverse effects is recommended when these medicines are concomitantly administered with antiretroviral doses of ritonavir (see section 4.4).
Maltese: Meta dawn il-mediċini jittieħdu flimkien ma' dożi antiretrovirali ta' ritonavir, hija rrakkomandata osservazzjoni b'attenzjoni ta' effetti terapewtiċi u avversi (ara sezzjoni 4.4).
English: How do I take the correct dose of Norvir powder for oral suspension mixed with food (full sachet)?
Maltese: Kif għandi nieħu d-doża korretta ta' trab għal suspensjoni orali Norvir mħallat mal-ikel (qartas wieħed)?
English: Inhibition of HIV protease renders the enzyme incapable of processing the gag-pol polyprotein precursor which leads to the production of HIV particles with immature morphology that are unable to initiate new rounds of infection.
Maltese: L-impediment tal-protejaż tal-HIV tirrendi inkapaċi l-enzima li tipproċessa l-prekursur poliproteina gag-pol li twassal għall-produzzjoni tal-partiċelli tal-HIV b'morfologija immatura, li ma jkunux kapaċi jinizjaw ċirki ġodda ta' infezzjoni.
English: Ritonavir dosed as a pharmacokinetic enhancer or as an antiretroviral agent inhibits CYP3A4 and as a result is expected to increase the plasma concentrations of fentanyl.
Maltese: Ritonavir f'doża biex iżid l-effett farmakokinetiku jew bħala aġent antiretrovirali jimpedixxi s-CYP3A4, u għalhekk huwa mistenni li jżid ilkonċentrazzjoni fil-plażma ta' fentanyl.
English: 6 vials l t o r
Maltese: <Numru tal-proċedura ta' l-EMEA> <Numru ta' l-EU>
English: Vial (glass)
Maltese: Mnejn jingħata
English: 6.25 mg Powder for solution for injection Intravenous use
Maltese: Għall-użu fil-vina Fjala (ħġieġ)
English: Further information on Semglee can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Semglee (insulin glargine) EMA/57790/2018
Maltese: Semglee (insulina glargina) EMA/57790/2018
English: Semglee (insulin glargine)
Maltese: Semglee (insulina glargina)
English: It contains the active substance insulin glargine.
Maltese: Dan fih issustanza attiva insulina glargina.
English: Semglee is a ‘biosimilar medicine'.
Maltese: Semglee hija ‘mediċina bijosimili'.
English: Patients in the study had previously had their level of glycosylated haemoglobin (HbA1c), a substance which indicates how well blood glucose is controlled, brought under control with Lantus; continuing treatment with either Semglee or Lantus for 24 weeks indicated comparable control of HbA1c levels with both, the level changing by an average of 0.14% in patients given Semglee, and 0.11% in those given Lantus.
Maltese: Il-pazjenti fl-istudju, preċedentement, kellhom il-livell tal-emoglobina glikożilata (HbA1c) tagħhom, sustanza li tindika kemm jiġi kkontrollat tajjeb il-glukożju fid-demm, ikkontrollat b'Lantus; il-kontinwazzjoni tal-kura b'jew Semglee jew Lantus għal 24 ġimgħa indikat kontroll komparabbli tal-livelli ta' HbA1c bit-tnejn li huma, il-livell inbidel b'medja ta' 0.14 % f'pazjenti li ngħataw Semglee, u 0.11 % f'dawk li ngħataw Lantus.
English: The reference medicine for Semglee is Lantus.
Maltese: Il-mediċina ta' referenza għal Semglee hija Lantus.
English: Other information about Semglee
Maltese: Informazzjoni oħra dwar Semglee
English: Extensive laboratory studies comparing Semglee with Lantus have shown that insulin glargine in Semglee is highly similar to that in Lantus in terms of chemical structure, purity and biological activity.
Maltese: Studji estensivi fil-laboratorju li qabblu Semglee ma' Lantus urew li l-insulina glargina f'Semglee hija simili ħafna għal dak f'Lantus f'termini ta' struttura kimika, purità u attività bijoloġika.
English: However, a supportive study in 558 patients with type 1 diabetes showed Semglee and Lantus had similar effects.
Maltese: Madankollu, studju ta' appoġġ f'558 pazjent b'dijabete tat-tip 1 wera li Semglee u Lantus kellhom effetti simili.
English: What are the risks associated with Semglee?
Maltese: X'inhuma r-riskji assoċjati ma' Semglee?
English: As for all medicines, data on the use of Semglee is continuously monitored.
Maltese: Bħal mhu l-każ għall-mediċini kollha, id-data dwar l-użu ta' Semglee hija ssorveljata kontinwament.
English: How is Semglee used?
Maltese: Semglee?
English: For the full list of side effects and restrictions with Semglee, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u restrizzjonijiet b'Semglee, ara l-fuljett ta' tagħrif.
English: Side effects reported with Semglee are carefully evaluated and any necessary action taken to protect patients.
Maltese: Leffetti sekondarji rrappurtati b'Semglee huma evalwati bir-reqqa u kull azzjoni meħtieġa hi meħuda biex tipproteġi lill-pazjenti.
English: Additional studies showed that Semglee is absorbed into the body in the same way as the reference medicine, Lantus, and could be considered to act similarly on blood glucose.
Maltese: Studji addizzjonali wrew li Semglee jiġi assorbit fil-ġisem bl-istess mod bħall-mediċina ta' referenza, Lantus, u jista' jiġi kkunsidrat li jaġixxi b'mod simili fuq il-glukożju fid-demm.
English: Insulin glargine, the active substance in Semglee, enters the bloodstream more slowly than human insulin after injection and so it works for longer.
Maltese: L-insulina glargina, is-sustanza attiva f'Semglee, tidħol fil-fluss tad-demm aktar bil-mod mill-insulina tal-bniedem wara l-injezzjoni u b'hekk taħdem għal żmien itwal.
English: This means that Semglee is highly similar to another biological medicine (the ‘reference medicine') that is already authorised in the EU.
Maltese: Dan ifisser li Semglee huwa simili ħafna għal mediċina bijoloġika oħra (il-'mediċina ta' referenza') li diġà hija awtorizzata fl-UE.
English: The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Semglee has been shown to have a comparable quality, safety and effectiveness to Lantus.
Maltese: L-Aġenzija Ewropea għall-Mediċini ddeċidiet li, b'mod konformi mar-rekwiżiti tal-UE għal mediċini bijosimili, Semglee wera li għandu kwalità, sigurtà u effikaċja komparabbli għal Lantus.
English: The most common side effect with Semglee (which may affect more than 1 in 10 people) is hypoglycaemia (low blood glucose).
Maltese: L-effett sekondarju l-aktar komuni b'Semglee (li jista' jaffettwa aktar minn persuna 1 minn kull 10) huwa ipogliċemija (glukożju baxx fid-demm).
English: Because Semglee is a biosimilar medicine, studies on effectiveness and safety were not needed as these have been well established for insulin glargine.
Maltese: Minħabba li Semglee huwa mediċina bijosimili, ma kinux meħtieġa studji dwar l-effettività u s-sigurtà peress li dawn ġew stabbiliti tajjeb għall-insulina glargina.
English: ·kg and 5 hours, respectively.
Maltese: ·kg u 5-sigħat, rispettivament.
English: Urticaria, Pruritus, Alopecia
Maltese: Urtikarja, Ħakk, Alopeċja
English: Powder: Human albumin, mannitol.
Maltese: Human albumin, mannitol.
English: List 1:
Maltese: Lista 1:
English: List 2:
Maltese: Lista 2:
English: Pharmacotherapeutic group: Immunostimulants, interferons, ATC Code: L03AB08
Maltese: Immunostimulanti, interferoni, Kodiċi ATC: L03AB08
English: • Medicine
Maltese: • Mediċina
English: Nephrotic syndrome, glomerulosclerosis (see section 4.4)* , #
Maltese: Sindrom nefrotiku, glomerulosklerożi (ara taqsima 4.4)*
English: Extavia contains sodium
Maltese: Extavia fih sodium
English: Extavia may cause side effects in the central nervous system (see section 4 “Possible side effects”).
Maltese: Extavia jista' jikkawża effetti sekondarji fis-sistema ċentrali nervuża (ara sezzjoni 4. “Effetti sekondarji possibbli”).
English: Anorexia*
Maltese: Anoressija*
English: 1.2 ml sodium chloride solution 5.4 mg/ml
Maltese: 1.2 ml soluzzjoni ta' sodium chloride 5.4 mg/ml
English: Interferon alpha, interferon beta, and interferon gamma have overlapping yet distinct biological activities.
Maltese: Interferon alfa, interferon beta u interferon gamma għandhom karatteristiċi bioloġiċi komuni iżda distinti.
English: Date of first authorisation: 20 May 2008 Date of latest renewal: 20 May 2013
Maltese: Data tal-aħħar tiġdid: 20 Mejju 2013
English: Rare (1/10,000 to
Maltese: Rari (1/10,000 sa <1/1,000)
English: 187.5 microgram
Maltese: 187.5 mikrogramm
English: Gamma-glutamyltransferase increased, Hepatitis
Maltese: Żieda tal-gammaglutamyl-transferase, Epatite
English: Three major classes of interferons have been identified: alpha, beta, and gamma.
Maltese: Tliet klassijiet prinċipali ta' interferoni ġew identifikati: alfa, beta, u gamma.
English: 62.5 microgram
Maltese: 62.5 mikrogramm
English: System Organ Class
Maltese: Sistema ta' klassifika talorgani
English: 125 microgram
Maltese: 125 mikrogramm
English: Cardiomyopathy*
Maltese: Kardjomijopatija*
English: 250 microgram
Maltese: 250 mikrogramm
English: Urinary incontinence
Maltese: Inkontinenza awrinarja
English: EU/1/08/454/008 15 vials with powder and 15 pre-filled syringes with solvent EU/1/08/454/010 5 vials with powder and 5 pre-filled syringes with solvent EU/1/08/454/011 14 vials with powder and 14 pre-filled syringes with solvent EU/1/08/454/013 14 vials with powder and 15 pre-filled syringes with solvent
Maltese: EU/1/08/454/008 15-il kunjett bi trab u 15-il siringa mimlijin għal-lest b'solvent EU/1/08/454/010 5 kunjetti bi trab u 5 siringi mimlijin għal-lest b'solvent EU/1/08/454/011 14 il-kunjett bi trab u 14-il siringa mimlijin għal-lest b'solvent EU/1/08/454/013 14 il-kunjett bi trab u 15-il siringa mimlijin għal-lest b'solvent
English: A) General advice
Maltese: A) Parir ġenerali
English: Based on animal data (see section 5.3), there is a possibly increased risk for spontaneous abortion.
Maltese: Skont data minn annimali (ara sezzjoni 5.3), hemm il-possibbiltà ta' żieda fir-riskju ta' korriment spontanju.
English: Confusional state
Maltese: Stat ta' konfużjonali
English: What Extavia contains The active substance is interferon beta-1b.
Maltese: Is-sustanza attiva hi interferon beta-1b.
English: Thrombocytopenia Thrombotic microangiopathy including thrombotic thrombocytopenic purpura/haemolytic uraemic syndrome#
Maltese: Tromboċitopenija Mikroanġjopatija trombotika li tinkludi purpura tromboċitopenika trombotika/sindrome emolitika uraemika#
English: Table 1 Adverse events and laboratory abnormalities with incidence rates ≥10% and the respective percentages under placebo; significantly associated side effects <10% based on reports from clinical trials
Maltese: Tabella 1 Effetti avversi li ġraw ≥10% u l-perċentwali rispettivi għall-plaċebo; effetti oħra assoċjati b'mod sinnifikattiv <10% skont rapporti bbażati fuq provi kliniċi