FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients should be informed of the early signs of hypersensitivity reactions including hives, generalised urticaria, tightness of the chest, wheezing, hypotension and anaphylaxis.
Maltese: Il-pazjenti għandhom jiġu informati bis-sinjali bikrija ta' reazzjonijiet ta' sensittività eċċessiva inkluż ħorriqija, urtikarja ġeneralizzata, għafis tas-sider, tħarħir, pressjoni baxxa u anafilassi.
English: The reconstituted solution in each vial contains 2100 U conestat alfa at 150 U/ml.
Maltese: Is-soluzzjoni rikostitwita f'kull kunjett fiha 2100 U conestat alfa f'150 U/ml.
English: • 1 powder vial
Maltese: • 1 kunjett bit-trab
English: This may indicate that you have developed an allergy to Ruconest.
Maltese: Dan jista' jindika li inti żviluppajt allerġija għal Ruconest.
English: One administration kit contains:
Maltese: Linformazzjoni miġbura għandha tinkludi:
English: Solvent vial: 20 ml of water for injections in a vial (type 1 glass) with a stopper (siliconized chlorobutyl rubber) and a flip-off seal (aluminium and coloured plastic).
Maltese: Kunjett bis-solvent: 20 ml ta' ilma għall-injezzjonijiet f'kunjett (ħġieġ ta' tip 1), b'tapp (lastku talchlorobutyl silikonizzat) u siġill flip-off (aluminju u plastik tal-kulur).
English: Vertigo Paraesthesia
Maltese: Paraesteżja orali
English: Hepatic impairment may prolong the plasma half-life of conestat alfa, but this is not thought to be a clinical concern.
Maltese: Indeboliment tal fwied jista' jtawwal il-half-life tal-plasma ta' conestat alfa, iżda dan mhuwiex maħsub li huwa ta' tħassib kliniku.
English: Step 12: Administration of the prepared solution
Maltese: Pass 12: L-għoti tas-soluzzjoni ppreparata
English: • 1 vial of 2100 U powder
Maltese: • kunjett ta' 2100
English: Powder vial
Maltese: TAGĦRIF
English: Each vial of Ruconest (2100 U) should be reconstituted with 14 ml water for injections.
Maltese: Kull kunjett ta' Ruconest (2100 U) għandu jiġi rikostitwit b'14 ml ilma għall-injezzjonijiet.
English: The effect of conestat alfa on the following target proteases was assessed in vitro: activated C1s, kallikrein, factor XIIa and factor XIa.
Maltese: C1s attivati, kallikrein, fattur XIIa u fattur XIa.
English: Leave the syringe on the adapter.
Maltese: Ħalli ssiringa fuq l-adapter.
English: The information collected should include:
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq:
English: • Known or suspected allergy to rabbits (see section 4.4) • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1
Maltese: • Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe wieħed mill-eċċipjenti elenkati fis-sezzjoni 6.1.
English: In an open label study 114/119 (95%) attacks treated with a single dose of 50 U/kg reached time to beginning of relief within 4 hours.
Maltese: Fl-istudju bit-tikketta mikxufa, 114/119 (95%) tal-attakki b'doża waħda ta' 50
English: One case of hypersensitivity was observed in clinical trials with Ruconest.
Maltese: Każ wieħed ta' sensittività eċċessiva ġie osservat fi provi kliniċi b'Ruconest.
English: Diarrhoea
Maltese: Paraesteżja
English: Ruconest is to be used by adults and adolescents with a rare inherited blood disorder, called Hereditary Angioedema (HAE).
Maltese: Anġjoedema li Tintiret (HAE - Hereditary Angioedema).
English: MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Maltese: MANIFATTUR(I) TAS-SUSTANZA(I) BIJOLOĠIKA(ĊI) ATTIVA(I)
English: • Never exceed the volume of 14 ml per syringe.
Maltese: • Qatt m'għandek taqbeż il-volum tal-14 ml f'kull siringa.
English: Time (minutes) to beginning of relief median (95% CI)
Maltese: Ħin (minuti) għall-medjan tal-bidu tas-solliev (95% CI)
English: • Remove the plastic flip-off cap from the powder and solvent vials.
Maltese: • Neħħi l-għatu flip-off tal-plastik mill-kunjetti bit-trab u bis-solvent.
English: The efficacy and safety of Ruconest as a treatment of acute angioedema attacks in patients with HAE has been evaluated in two double blind randomized placebo controlled and four open label clinical studies.
Maltese: L-effikaċja u s-sigurtà ta' Ruconest bħala kura ta' attakki ta' anġjoedema akuti f'pazjenti b'HAE ġew evalwati f'żewġ studji kliniċi kkontrollati bi plaċebo randomizzati double blind u erba' studji kliniċi b'tikketta mikxufa.
English: • Leave the packaging on the adapter until you attach the syringe in steps 4 and 5.
Maltese: • Ħalli l-ippakkjar fuq l-adapter sakemm twaħħal is-siringa f'passi 4 u 5.
English: • Sensation of tingling, prickling or numbness in the skin or limb (paraesthesia)
Maltese: • Uġigħ addominali, dijarrea, dardir • Horriqija u nefħa tal-ġilda
English: • The other ingredients of the powder are sucrose, sodium citrate (E331) and citric acid.
Maltese: • Is-sustanzi l-oħra tat-trab huma sucrose, sodium citrate (E331) u citric acid.
English: Solvent vial: Do no store above 25°C.
Maltese: Taħżinx f'temperatura 'l fuq minn 25°C.
English: Ruconest 2100 Units powder for solution for injection conestat alfa
Maltese: Unità trab għal soluzzjoni għal injezzjoni conestat alfa
English: - Body weight up to 84 kg
Maltese: - Piż tal-ġisem ta' mhux aktar minn 84 kg
English: 1 infusion set with needle 2 alcohol pads 1 sterile non-woven pad 1 adhesive plaster
Maltese: - 1 jew 2 siringi bis-soluzzjoni ppreparata
English: The expiry date on the outer carton reflects the date of the component with the shortest shelf-life.
Maltese: Id-data ta' meta jiskadi fuq il-kaxxa tal-kartun ta' barra tirrifletti d-data talkomponent li jkollu l-iqsar ħajja.
English: • A physician will provide training on the following elements: - Precaution for storage - Dose calculation and indication (i.e. only acute HAE attacks) - Preparation of one dose of Ruconest (50 U/kg, up to 4200 U) by reconstituting one or two vials - Method of reconstitution of each powder vial - Technique of intravenous injection - Method and rate of administration of one dose of Ruconest - Guidance on use of a second dose of Ruconest - Instruction to immediately seek medical attention in case of failure to gain venous access, in case of lack of efficacy, in the event of any adverse reaction including hypersensitivity, or after self administering Ruconest for an acute laryngeal HAE attack.
Maltese: - Istruzzjoni dwar kif għandhom jiġu mmaniġġjati reazzjonijiet avversi possibbli tal-mediċina, li jinkludu reazzjoni tal-sensittività eċċessiva akuta - Informazzjoni dwar il-ħtieġa li jinżamm djarju sabiex tittieħed nota ta' kull kura li tkun ingħatat id-dar u biex jinġab mill-pazjent għal kull waħda mill-viżti għand it-tabib. Linformazzjoni rreġistrata għandha tinkludi: - Data u ħin tal-kura
English: Advice about the immunogenicity laboratory testing program for these antibodies provided by the company for following up suspected emergence of neutralising antibodies and information about the procedure to follow for the collection and shipment of a blood sample to the company's central laboratory.
Maltese: immunoġeniċità għal dawn l-antikorpi ipprovdut mill-kumpanija għall-follow-up ta' feġġa suspettata ta' antikorpi newtralizzanti u ta' informazzjoni dwar il-proċedura li għandha tiġi segwita għall-ġbir u bgħit ta' kampjun tad-demm lil-laboratorju ċentrali tal-kumpanija.
English: Ruconest will be initiated by a doctor who is specialised in the diagnosis and treatment of hereditary angioedema.
Maltese: Ruconest ser jinbeda minn tabib li huwa speċjalizzat fid-dijanjosi u l-kura ta' anġjoedema ereditarja.
English: If you experience allergic reactions e.g. hives, rash, itching, dizziness, wheezing, difficulty breathing or your tongue swells up following the administration of Ruconest, you should seek emergency medical assistance so that symptoms of your allergic reaction can be treated urgently.
Maltese: Jekk tesperjenza reazzjonijiet allerġiċi eż. ħorriqija, raxx, ħakk, sturdament, tħarħir, diffikultà fit-teħid tan-nifs, nefħa f'ilsienek wara l-għoti ta' Ruconest, għandek tfittex għajnuna medika ta' emerġenza sabiex is-sintomi tar-reazzjoni allerġika tiegħek ikunu jistgħu jiġu kkurati b'mod urġenti.
English: • Use of Ruconest is only approved in acute attacks of hereditary angioedema.
Maltese: • L-użu ta' Ruconest hu approvat biss f'każ ta' attakki akuti ta' anġjoedema ereditarja.
English: For intravenous use.
Maltese: endoġenuż.
English: Conestat alfa is the recombinant analogue of the human C1 esterase inhibitor (rhC1INH) produced by recombinant DNA technology in the milk of transgenic rabbits.
Maltese: Conestat alfa huwa l-analogu rikombinanti tal-inibitur esterase C1 tal-bniedem (rhC1INH) prodott b'teknoloġija rikombinanti tad-DNA fil-ħalib ta' fniek transġeniċi.
English: Hold the syringe with the tip pointing upwards and gently press the plunger to fill the infusion set with the solution Disinfect the injection site with an alcohol pad.
Maltese: Rappurtar ta' reazzjonijiet avversi suspettati Huwa importanti li jiġu rrappurtati reazzjonijiet avversi suspettati wara l-awtorizzazzjoni tal-prodott mediċinali.
English: • The need to inform patients about the early signs of hypersensitivity reactions including hives, generalised urticaria, tightness of the chest, wheezing, hypotension and anaphylaxis, and that they should alert their physician if these symptoms occur.
Maltese: • Il-ħtieġa li pazjenti jiġu infurmati bis-sinjali bikrin ta' reazzjonijiet ta' sensittività eċċessiva inkluż ħorriqija, urtikarja ġeneralizzata, għafis fuq is-sider, tħarħir, pressjoni baxxa u anafilassi, u li għandhom javżaw lit-tabib tagħhom jekk iseħħu dawn is-sintomi.
English: Conestat alfa is derived from milk of transgenic rabbits and contains traces of rabbit protein.
Maltese: Conestat alfa jinkiseb mill-ħalib ta' fniek transġeniċi u fih traċċi tal-proteina tal-fniek.
English: - check the expiry date.
Maltese: DATA TA' REVIŻJONI TAT-TEST
English: • Unlock the syringe(s) by turning it counter-clockwise and discard the vial(s) with adapter.
Maltese: • Żomm l-adapter bl-id l-oħra u waħħal is-siringa.
English: Gently inject the solution into the vein - inject over about 5 minutes.
Maltese: Injetta bil-mod is-soluzzjoni ġol-vina - injetta fuq perjodu ta' madwar 5 minuti.
English: Swelling
Maltese: Sturdament
English: The other ingredients are sucrose, sodium citrate (E331) and citric acid.
Maltese: Is-sustanzi l-oħra huma sucrose, sodium citrate (E331) u citric acid.
English: Efficacy of Ruconest as a treatment for acute angioedema attacks was demonstrated by significantly shorter time to beginning of relief of symptoms and time to minimal symptoms and few therapeutic failures.
Maltese: L-effikaċja ta' Ruconest bħala kura għal attakki ta' anġjoedema akuti ntweriet minn ħin ferm iqsar sal-bidu tas-solliev tas-sintomi u ħin għal sintomi minimi u ftit fallimenti terapewtiċi.
English: Reporting of suspected adverse reactions
Maltese: - Kwalunkwe avvenimenti avversi
English: Dose calculation
Maltese: U KWANTITATTIVA
English: Although cross-reactivity between cow milk and rabbit milk is considered unlikely, the possibility of such a cross-reactivity in a patient who has evidence of clinical allergy to cow milk cannot be excluded and the patient should be observed for signs and symptoms of hypersensitivity following Ruconest administration.
Maltese: Għalkemm reattività trasversali bejn il-ħalib tal-baqra u l-ħalib tal-fenek hija kkunsidrata improbabbli, il-possibbiltà ta' tali reattività trasversali f'pazjent b'evidenza ta' allerġija klinika għall-ħalib tal-baqra ma tistax tiġi eskluża, u l-pazjent għandu jiġu osservat għal sinjali u sintomi ta' sensittività eċċessiva wara l-għoti ta' Ruconest.
English: The expiry date refers to the last day of that month.
Maltese: - iċċekkja d-data ta' meta jiskadi.
English: Continue to fill the syringe with 14 ml solvent.
Maltese: Kompli imla s-siringa b'14 ml ta' solvent.
English: C1INH exerts an inhibitory effect on several proteases (target proteases) of the contact and complement systems.
Maltese: C1INH jeżerċita effett inibitorju fuq bosta proteażi (proteażi fil-mira) tas-sistemi ta' kuntatt u kumpliment.
English: One powder vial contains 2100 U of conestat alfa, corresponding to 2100 U/14 ml after reconstitution, or a concentration of 150 U/ml.
Maltese: Kull kunjett fih 2100 unità (U) ta' conestat alfa, li jikkorrespondu għal 2100 unità għal kull 14 ml wara rikostituzzjoni, jew konċentrazzjoni ta' 150 unità/ml.
English: • Summary of Product Characteristics and Patient Information Leaflet for Ruconest
Maltese: • Sensazzjoni ta' tagħrix, qris jew nuqqas ta' sensittività fil-ġilda jew tad-dirgħajn/riġlejn
English: Paediatric population The safety and efficacy of Ruconest in children (age 0 to 12 years) have not yet been established.
Maltese: Is-sigurtà u l-effikaċja ta' Ruconest fit-tfal minn età 0 sa 12-il sena ma ġewx determinati s'issa.
English: Unlock the syringe from the adapter by turning counter clockwise and discard the vial with adapter.
Maltese: Ħoll is-siringa minn mal-adapter billi ddawwar lejn ix-xellug u armi l-kunjett bl-adapter.
English: If not used immediately in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8ºC, unless reconstitution has taken place in controlled and validated aseptic conditions.
Maltese: il-ħinijiet ta' ħżin waqt l-użu u l-kondizzjonijiet qabel l-użu huma r-responsabbiltà tal-utent u normalment ma jkunux itwal minn 24 siegħa f'temperatura ta' 2 to 8ºC, diment li r-rikostituzzjoni tkun saret f'kondizzjonijiet asettiċi kkontrollati u vvalidati.
English: • the batch number written on the label of the powder vial
Maltese: • Numru tal-lott u d-doża riċevuta
English: Pregnancy and breast-feeding
Maltese: Preparazzjoni tas-soluzzjoni
English: Prior to launch of the product in each Member State, the Marketing Authorisation Holder (MAH) shall agree the content and format of the educational material with the National Competent Authority (NCA).
Maltese: Qabel it-tnedija tal-prodott f'kull Stat Membru, id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq (MAH) għandu jaqbel fuq il-kontenut u l-format tal-materjal edukattiv mal-Awtorità Kompetenti Nazzjonali (NCA).
English: • Remove the packaging from the adapter on the powder vial.
Maltese: • Żomm l-adapter b'id waħda.
English: Each vial contains 2100 units of conestat alfa, corresponding to 2100 units per 14 ml after reconstitution, or a concentration of 150 units/ml.
Maltese: U KWANTITATTIVA Kunjett wieħed fih 2100 unità ta' conestat alfa, li jikkorrespondu għal 2100 unità għal kull 14 ml wara rikostituzzjoni, jew konċentrazzjoni ta' 150 unità/ml.
English: Adverse reactions were usually mild to moderate in severity.
Maltese: Normalment, ir-reazzjonijiet avversi kienu ħfief għal moderati fis-serjetà tagħhom.
English: The clinical experience supporting safety of Ruconest consists of 300 administrations (83 administrations to healthy subjects or asymptomatic HAE patients and 217 administrations to 119 HAE patients).
Maltese: amministrazzjoni fuq suġġetti b'saħħithom jew fuq pazjenti b'HAE mingħajr sintomi u 217-il amministrazzjoni lil 119 pazjent b'HAE).
English: The administration of Ruconest is to resolve the shortage of C1 inhibitor and will lead to reduction of symptoms of an acute attack of HAE.
Maltese: Ruconest jingħata biex isolvi nuqqas ta' inibitur C1 u jwassal għal nuqqas tas-sintomi ta' attakk akut ta' HAE.
English: Each vial of Ruconest contains 19.5 mg of sodium.
Maltese: Kull kunjett ta' Ruconest fih 19.5 mg ta' sodju.
English: Genotoxic and carcinogenic potential is not expected.
Maltese: Mhuwiex mistenni potenzjal ġenotossiku u karċinoġeniku.
English: • Fold down the yellow protection cap over the needle.
Maltese: • Itwi 'l isfel l-għatu protettiv isfar fuq il-labra.
English: Skin and subcutaneous tissue disorders
Maltese: Preparazzjoni tas-sett tal-infużjoni
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Ruconest in one or more subsets of the paediatric population in treatment of acute angioedema attacks (see section 4.2 for information on paediatric use).
Maltese: L-Aġenzija Ewropea għall-Mediċini iddifferiet l-obbligi li jiġu ppreżentati riżultati tal-istudji b'Ruconest f'wieħed jew iktar settijiet tal-popolazzjoni pedjatrika fil-kura ta' attakki ta' anġjoedema akuta (ara sezzjoni 4.2 għal informazzjoni dwar l-użu pedjatriku).
English: Ruconest will be given to you directly into a vein over a period of approximately 5 minutes by your doctor or by a nurse.
Maltese: Ruconest sejjer jingħata lilek direttament f'vina fuq perjodu ta' bejn wieħed u ieħor 5 minuti mit-tabib jew min-ners tiegħek.
English: Solvent for Ruconest Water for injections
Maltese: U Trab u solvent għal soluzzjoni għal injezzjoni
English: After reconstitution with 14 ml water for injections, the solution contains 150 U conestat alfa per ml.
Maltese: Wara rikostituzzjoni b'14 ml ilma għall-injezzjonijiet, is-soluzzjoni fiha 150 U conestat alfa għal kull ml
English: • Ensure the kit package is complete and contains all components listed in section 6 of this leaflet.
Maltese: • Żgura l-pakkett tal-kitt ikun sħiħ u li jkun fih il-komponenti kollha elenkati f'sezzjoni 6 ta' dan il fuljett.
English: Renal impairment
Maltese: Skumdità addominali
English: The table below shows the results (primary and secondary endpoints) of the two randomized controlled trials:
Maltese: It-tabella t'hawn taħt turi r-riżultati (punti ta' tmiem primarji u sekondarji) taż-żewġ provi kkontrollati randomizzati:
English: These patients have a shortage of the C1 inhibitor protein in their blood.
Maltese: Dawn il-pazjenti għandhom nuqqas tal proteina inibitur C1 f'demmhom.
English: Excretion
Maltese: Fertilità
English: Before initiating treatment with Ruconest, patients should be queried about prior exposure to rabbits and signs and symptoms suggestive of an allergic reaction.
Maltese: Qabel il-bidu tat-trattament b'Ruconest, il-pazjenti għandhom jiġu mistoqsija dwar espożizzjoni preċedenti għallfniek u sinjali u sintomi li jissuġġerixxu reazzjoni allerġika.
English: • Abdominal pain, diarrhoea, nausea
Maltese: • Uġigħ addominali, dijarrea, dardir • Horriqija u nefħa tal-ġilda.
English: • That patients treated with Ruconest should be monitored for clinical signs and symptoms of hypersensitivity during administration.
Maltese: • Li pazjenti kkurati b'Ruconest għandhom jiġu mmonitorjati għal sinjali kliniċi u għal sintomi ta' sensittività eċċessiva matul l-għoti.
English: Powder for solution for injection.
Maltese: U Trab għal soluzzjoni għal injezzjoni.
English: • Check that all required components are on the work surface: - 1 or 2 syringes with prepared solution - 1 infusion set with 25G needle - 1 alcohol pad - 1 sterile non-woven pad - 1 self-adhesive plaster - 1 tourniquet - 1 plaster for securing the needle
Maltese: Tneħħix l-ippakkjar tas-siringa. - 1 siringa jekk 1 kunjett bit-trab u 1 kunjett bis-solvent ikunu meħtieġa - 2 siringi jekk 2 kunjetti bit-trab u 2 kunjetti bis-solvent ikunu meħtieġa
English: Step 8: Check prepared syringes • Recheck that the volume in the syringe(s) you prepared in step 7 is correct.
Maltese: Pass 8: Iċċekkja s-siringi ppreparati
English: One vial contains 2100 units of conestat alfa, corresponding to 2100 units per 14 ml after reconstitution, or a concentration of 150 units/ml.
Maltese: Kunjett wieħed fih 2100 unità ta' conestat alfa, li jikkorrespondu għal 2100 unità għal kull 14 ml wara rikostituzzjoni, jew konċentrazzjoni ta' 150 unità/ml.
English: • Check whether the powder in the vial(s) has dissolved completely and the plunger is completely pushed down in the syringe.
Maltese: • Iċċekkja biex tara jekk it-trab fil-kunjett(i) inkunx inħall għal kollox, u li l-planġer ikun kompletament imbuttat 'l isfel ġos-siringa.
English: • Remove the needle cap.
Maltese: - Rispons għall-kura
English: In case of an insufficient clinical response, an additional dose (50 U/kg bodyweight up to 4200 U) can be administered (see section 5.1).
Maltese: 4200 U) (ara sezzjoni 5.1).
English: The reconstituted solution contains 150 U/ml conestat alfa and appears as a clear colourless solution.
Maltese: Is-soluzzjoni rikostitwita fiha 150 U/ml ta' conestat alfa u tidher bħala soluzzjoni ċara u bla kulur.
English: Administration into a vein
Maltese: Twissijiet u prekawzjonijiet
English: The doses evaluated in the clinical studies ranged from a single vial of 2100 U (corresponding to 18-40 U/kg), to 50 and 100 U/kg.
Maltese: Popolazzjoni pedjatrika Disa' pazjenti adoloxxenti b'HAE (ta' bejn 14 u 17-il sena) ġew ikkurati b'50 U/kg għal 26 attakk ta'
English: Date of first authorisation: 15 May 2002 Date of latest renewal: 15 May 2007
Maltese: Data tal-ewwel awtorizzazzjoni: 15 ta' Mejju 2002 Data tal-aħħar tiġdid: 15 ta' Mejju 2007
English: Oral solution Multipack: 500 ml (10 bottles of 50 ml) oral solution.
Maltese: Soluzzjoni orali Pakkett multiplu: 500 ml (10 fliexken ta' 50 ml) soluzzjoni orali.
English: Ebixa 5 mg, 10 mg, 15 mg, 20 mg tablets
Maltese: Ebixa pilloli ta' 5 mg, 10 mg, 15 mg, 20 mg
English: Excipients with known effect: Each millilitre of solution contains 100 mg sorbitol (E420) and 0.5 mg potassium, see section 4.4.
Maltese: Kull millilitru ta' soluzzjoni fiha 100 mg sorbitol (E420) u 0.5 mg potassju, ara sezzjoni 4.4.
English: 2500 Valby Denmark.
Maltese: 2500 Valby Id-Danimarka.
English: Mon → Tue → Wed → Thu → Fri → Sat → Sun
Maltese: Kellem lit-tabib jew l-ispiżjar tiegħek qabel tieħu Ebixa
English: EU/1/02/219/ 013500 ml (10 bottles of 50 ml)
Maltese: EU/1/02/219/013 500 ml (10 fliexken ta' 50 ml)
English: EU/1/02/219/001-003 EU/1/02/219/007-012 EU/1/02/219/014-021 EU/1/02/219/023-035 EU/1/02/219/037-049
Maltese: EU/1/02/219/001-003 EU/1/02/219/007-012 EU/1/02/219/014-021 EU/1/02/219/023-035
English: Week 2 (day 8-14)
Maltese: Ġimgħa 2 (jum 8-14):
English: EU/1/02/219/022 7 x 5 mg + 7 x 10 mg + 7 x 15 mg 7 x 20 mg film-coated tablets EU/1/02/219/036 7 x 5 mg + 7 x 10 mg + 7 x 15 mg 7 x 20 mg film-coated tablets
Maltese: EU/1/02/219/022 7 x 5 mg + 7 x 10 mg + 7 x 15 mg 7 x 20 mg pilloli miksijin b'rita.
English: The most frequently occurring adverse reactions with a higher incidence in the Ebixa group than in the placebo group were dizziness (6.3% vs 5.6%, respectively), headache (5.2% vs 3.9%), constipation (4.6% vs 2.6%), somnolence (3.4% vs 2.2%) and hypertension (4.1% vs 2.8%).
Maltese: L-aktar reazzjonijiet avversi li seħħew ta' spiss fil-grupp ta' Ebixa milli fil-grupp tal-plaċebo kienu sturdament (6.3% vs 5.6%, rispettivament), uġigħ ta' ras (5.2% vs 3.9%), stitikezza (4.6% vs 2.6%), ngħas (3.4% vs 2.2%) u pressjoni għolja (4.1% vs 2.8%).
English: Ebixa contains sorbitol
Maltese: Ebixa fih sorbitol
English: Patients with rare hereditary problems of fructose intolerance should not take this medicine.
Maltese: Pazjenti bi problemi ereditarji rari ta' intolleranza għal fruttosju m'għandhomx jieħdu din il-mediċina.
English: The next time the dosing pump head is pushed downwards completely (equivalent to one pump actuation), it dispenses the correct dose (1 pump actuation is equivalent to 0.5 ml oral solution, and contains 5 mg of the active substance memantine hydrochloride; fig. 6).
Maltese: Meta ras il-pompa terġa' tingħafas l-isfel kompletament (ekwivalenti għal attwazzjoni bil-pompa waħda), toħroġ id-doża korretta (attwazzjoni bil-pompa waħda hija ekwivalenti għal 0.5 ml ta' soluzzjoni orali, u fiha 5 mg tas-sustanza attiva memantine hydrochloride; fig. 6).
English: CARTON FOR 28 TABLETS - TREATMENT INITIATION PACK - 4 WEEK TREATMENT SCHEDULE
Maltese: KARTUNA GĦAL 28 PILLOLA - PAKKETT TA' KURA TAL-BIDU - TRATTAMENT SKEDAT FUQ 4 ĠIMGĦAT
English: Perforated unit dose blister: PVDC/PE/PVC/Al-blister or PP/Al-blister Pack sizes 49 x 1, 56 x1, 98 x 1 and 100 x 1 film-coated tablets .
Maltese: Folja b'doża waħda mtaqqba bil-lest: folja-PVDC/PE/PVC/Al jew folja-PP/Al Daqsijiet ta' pakketti 49 x 1, 56 x1, 98 x 1 u 100 x 1 pilloli miksijin b'rita .
English: 2500 Valby Denmark
Maltese: 2500 Valby Id-Danimarka
English: Fertility No adverse reactions of memantine were noted on male and female fertility.
Maltese: Fertilità Ma dehru ebda reazzjonijiet avversi ta' memantine fuq il-fertilità maskili u femminili.