FrancophonIA/ELRC3.0 huggingface dataset:
English: Clinical efficacy was re-assessed at follow-up visits 6 and 12 months after the last photodynamic therapy.
Maltese: L-effikaċja klinika ġiet evalwata mill-ġdid f'viżti ta' segwitu 6 u 12-il xahar wara l-aħħar terapija fotodinamika.
English: There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of 5-aminolaevulinic acid in pregnant women.
Maltese: M'hemmx dejta jew hemm dejta limitata (inqas minn 300 riżultat ta' tqala) dwar l-użu tal5-aminolaevulinic acid f'nisa tqal.
English: Propylene glycol may cause irritation.
Maltese: Il-propylene glycol jista'
English: MAL Full lesion clearance n (%)
Maltese: MAL Numru ta' pazjenti n (%)
English: • Discontinue any UV-therapy before treatment.
Maltese: • Waqqaf kull terapija bil-UV qabel it-trattament.
English: The incidence of adverse reactions in 574 subjects exposed to photodynamic therapy with Ameluz in pivotal clinical trials is listed below.
Maltese: L-inċidenza ta' reazzjonijiet avversi f'574 suġġett esposti għal terapija fotodinamika b'Ameluz fi provi kliniċi importanti ħafna qed tiġi elenkata hawn taħt.
English: Prior to the decision to undergo photodynamic therapy it should be taken into consideration that the probability of a subject to be completely cleared 12 months after the last treatment was 67.5% or 46.8% for treatment with Ameluz with narrow spectrum lamps or all lamp types, respectively.
Maltese: Qabel jidħol għal terapija fotodinamika, il-probabbiltà tas-suġġett li jitfejjaq kompletament 12-il xahar wara l-aħħar kura kienet 67.5% jew 46.8% għal kura b'Ameluz b'lampi bi spettru dejjaq jew it-tipi ta' lampi kollha rispettivament.
English: A class waiver exists for basal cell carcinoma (see section 4.2 for information on paediatric use).
Maltese: Għal karċinoma taċ-ċelluli bażali teżisti rinunzja tal-klassi (ara sezzjoni 4.2 għal informazzjoni dwar l-użu pedjatriku). 5.2 Tagħrif farmakokinetiku
English: Taking into account the PRAC Assessment Report on the PSUR(s) for 5-aminolevulinic acid (keratosis), the scientific conclusions of the CHMP are as follows:
Maltese: Meta jiġi kkunsidrat ir-Rapport ta' Valutazzjoni tal-PRAC dwar il-PSUR(s) għal 5-aminolevulinic acid (keratosis), il-konklużjonijiet xjentifiċi tas-CHMP huma kif ġej:
English: 1 mild flat, pink maculae without signs of hyperkeratosis and erythema, slight palpability, with AK felt better than seen
Maltese: 1 mild makuli ċatti, roża mingħajr sinjali ta' iperkeratosi u eritema, palpabilità ħafifa, b'AK tinħass aħjar milli tidher
English: The probability of patients in the Ameluz group to require only 1 treatment and remain completely cleared 12 months after the photodynamic therapy was 32.3%, that of patients in the MAL group 22.4% on average with all lamps.
Maltese: Il-probabbiltà medja bil-lampi kollha, tal-pazjenti fil-grupp ta' Ameluz li jeħtieġu kura waħda u jibqgħu kompletament imfejqa 12-il xahar wara l-kura fotodinamika kienet 32.3%, b'dik tal-pazjenti fil-grupp ta' MAL kienet 22.4%.
English: Ameluz Full lesion clearance n (%)
Maltese: Fejqan sħiħ tal leżjonijiet n (%)
English: Superficial (only) Nodular (only) Others (including mixed s/nBCCs) Thickness >1mm n.a.
Maltese: Oħrajn (li jinkludu s/nBCCs imħalltin)
English: None
Maltese: N
English: Table 3a: Skin quality parameters in the treated area during 12- month follow-up
Maltese: Tabella 3a: Parametri tal-kwalità tal-ġilda fiż-żona kkurata matul it-12-il xahar ta' follow-up Tip ta' indeboliment tal-ġilda
English: After only 1 PDT complete patient clearance resulted in 61.8 % vs. 9.4 %, and complete lesion clearance in 84.2 % vs. 22.0 % for Ameluz and placebo treatment, respectively.
Maltese: Wara biss 1 PDT, tneħħija kompleta tal-pazjenti rriżultat f'61.8% vs. 9.4%, u tneħħija kompleta talleżjonijiet f'84.2% vs.
English: Illumination with appropriate light produces reactive oxygen-containing molecules which act against the target cells.
Maltese: It-tidwil b'dawl xieraq tipproduċi molekuli reattivi li fihom l-ossiġnu li jaħdmu kontra ċċelloli fil-mira.
English: Ameluz is for cutaneous use.
Maltese: istoloġija jekk ikun meħtieġ.
English: c) Illumination: Immediately after cleaning the lesions, the entire treatment area will be illuminated with a red light source, either with a narrow spectrum around 630 nm and a light dose of approximately 37 J/cm2 or a broader and continuous spectrum in the range between 570 and 670 nm with a light dose between 75 and 200 J/cm2.
Maltese: Immedjatament wara li jitnaddfu l-leżjonijiet, l-erja tal-kura kollha tiddasġi illuminata b'sors ta' dawl aħmar, bi spettru dejjaq madwar 630 nm u b'doża ta' dawl ta' madwar 37 J/cm2 jew bi spettru usa' u kontinwu fil-medda ta' bejn 570 u 670 nm b'doża ta' dawl bejn 75 u 200
English: Unopened tube: 18 months After first opening: 12 weeks
Maltese: Tubu mhux miftuħ: 18-il xahar
English: Field cancerization is characterised by an area of skin where multiple AK lesions are present and there is likely to be an underlying and surrounding area of actinic damage (a concept known as field cancerization or field change); the extent of this area may not be evident visually or by physical examination.
Maltese: Kanċerizzazzjoni tal-kamp hi kkaratterizzata minn żona tal-ġilda fejn leżjonijiet multipli AK ikunu preżenti, u hu probabbli li jkun hemm żona sottostanti u tal-madwar ta' ħsara aktinika (kunċett magħruf bħala kanċerizzazzjoni tal-kamp jew bidla fil-kamp); il-firxa ta' din iż-żona tista' ma tkunx viżwalment evidenti jew permezz ta' eżami fiżiku.
English: 2 moderate pink to reddish papules and erythematous plaques with hyperkeratotic surface, moderately thick AK that are easily seen and felt
Maltese: 2 moderata Papuli roża fl-aħmar u plakek eritematużi b'wiċċ iperkeratotiku, AK moderatament ħoxna li jidhru u jinħassu faċilment
English: The primary endpoint was complete patient clearance after 12 weeks following the last photodynamic therapy.
Maltese: Il-punt aħħari primarju kien il-fejqan komplet tal-pazjent 12-il ġimgħa wara l-aħħar terapija fotodinamika.
English: In this study a total of 138 patients were treated with Ameluz.
Maltese: F'dan l-istudju, total ta' 138 pazjent ġew ikkurati b'Ameluz.
English: Pregnancy and breast-feeding
Maltese: Preparazzjoni tal-leżjonijiet
English: Ameluz can cause mucous membrane or eye irritation.
Maltese: Mhux meħtieġa garża okklussiva.
English: None of the post-dose levels were increased in comparison to the naturally occuring predose levels, showing absence of a relevant systemic absorption after topical administration.
Maltese: L-ebda wieħed mil-livelli ta' wara d-dożi ma żdied meta mqabbel mal-livelli ta' qabel id-doża li jseħħu b'mod naturali, li juri nuqqas ta' assorbiment sistemiku relevanti wara l amministrazzjoni topika.
English: Treatment of actinic keratosis of mild to moderate severity on the face and scalp (Olsen grade 1 to 2; see section 5.1) and of field cancerization in adults.
Maltese: Jista' jintuża spettru usa' u kontinwu jekk is sorsi ta' dawl bi spettru dejjaq ma jiġux ittollerati (ara sezzjoni 4.8 u 5.1).
English: After Ameluz treatment, 6.2% of the lesions were recurrent after 6 and additionally 2.9% after 12 months, respectively (placebo: 1.9% after 6 and additionally 0% after 12 months, respectively).
Maltese: L-effikaċja klinika nżammet matul il-perjodi ta' follow-up ta' 6 u 12-il xahar wara l-aħħar PDT. Wara l-kura b'Ameluz, 6.2% tal-leżjonijiet kienu rikorrenti wara 6 u addizzjonalment 2.9% wara 12-il xahar rispettivament (plaċebo: 1.9% wara 6 u addizzjonalment 0% wara 12-il xahar, rispettivament).
English: Wound secretion
Maltese: Spettru wiesa'
English: The complete lesion clearance rate for Ameluz in combination with a single daylight PDT was 79.8%, compared to 76.5% for comparator MAL.
Maltese: Ir-rata sħiħa ta' tneħħija tal-leżjonijiet għal Ameluz flimkien ma' PDT waħda b'dawl tax-xemx kienet ta' 79.8%, meta mqabbla ma' 76.5% għall-komparatur MAL.
English: Clinical efficacy was maintained during the follow-up periods of 6 and 12 months after the last photodynamic therapy.
Maltese: L-effikaċja klinika nżammet matul il-perjodi ta' segwitu ta' 6 u 12-il xahar wara l-aħħar terapija fotodinamika.
English: • Keep this leaflet.
Maltese: * Dejta mill-perjodu wara t-tqegħid fis-suq.
English: • soybean phosphatidylcholine: If you are allergic to peanut or soya, do not use this medicine.
Maltese: • soybean phosphatidylcholine:
English: Treatment of superficial and/or nodular basal cell carcinoma unsuitable for surgical treatment due to possible treatment-related morbidity and/or poor cosmetic outcome in adults.
Maltese: Kura ta' karċinoma taċ-ċelluli bażali superfiċjali u/jew nodulari, li ma tkunx adattata għal kura kirurġika minħabba l-possibbiltà ta ' morbidità relatata mal-kura u/jew riżultat kożmetiku batut fl adulti.
English: At application site: Vesicles, discharge, erosion, reaction, discomfort, hyperalgesia, haemorrhage, warmth
Maltese: Infafet, tnixxija ta' materja, erożjoni, reazzjoni, skumdità,
English: The cosmetic outcome was assessed as very good or good in 47.6% of the subjects in the Ameluz group compared to 25.0% of subjects in the placebo group.
Maltese: Ir-riżultat kosmetiku kien tajjeb ħafna jew tajjeb f'47.6% tas-suġġetti fil-grupp ta' Ameluz meta mqabbel ma' 25% fil-grupp tal-plaċebo.
English: As inflammatory response is important for the effect of PDT, the trials investigating the efficacy and safety of Ameluz excluded patients who were undergoing treatment with immunosuppression therapy.
Maltese: Lintensità ta' dawn l-effetti hija dipendenti fuq it-tip ta' tidwil użat għat-terapija fotodonamika.
English: Narrow spectrum Ameluz
Maltese: Tnixxija mill-ferita
English: Table 4: Efficacy of PDT for the treatment of BCC for all patients and selected subgroups Ameluz Patient number n (%)
Maltese: Tabella 4: L-effikaċja ta' PDT għall-kura ta' BCC għall-pazjenti kollha u s-sottogruppi magħżula
English: Apply sunscreen to sun exposed skin for sun protection 15 min before lesion treatment.
Maltese: Applika l-krema ta' protezzjoni mix-xemx fuq ġilda esposta għax-xemx 15-il minuta qabel it trattament tal-leżjoni.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Ameluz in all subsets of the paediatric population in actinic keratosis.
Maltese: Billi tirrapporta l-effetti sekondarji tista' tgħin biex tiġi pprovduta aktar informazzjoni dwar is-sigurtà ta' din il-mediċina.
English: c) Application of the gel: A thin layer of Ameluz should be applied to the lesion area or entire cancerized fields using glove protected fingertips or a spatula.
Maltese: c) Applikazzjoni tal-ġel: Għandu jiġi applikat saff irqiq ta' Ameluz fuq iż-żona tal-leżjoni jew iż-żoni kanċerużi sħaħ permezz tal-ponot tas-swaba protetti b'ingwanta jew bi spatula.
English: • unpleasant, abnormal sense of touch
Maltese: Korriment, avvelenament u komplikazzjonijiet ta' xi proċedura
English: Application of the gel
Maltese: Applikazzjoni tal-ġel
English: Ameluz contains soybean phosphatidylcholine and should not be applied to patients known to be allergic to peanut or soya (see section 4.3).
Maltese: Għandu jkun hemm attenzjoni speċjali biex tiġi evitata fsada matul il-preparazzjoni tal-leżjoni f'dawn il-pazjenti (ara sezzjoni 4.2).
English: In most patients an up to 2.5-fold increase of basic ALA plasma concentrations was observed during the first 3 hours after Ameluz application, which is still within the normal range of previously reported and published endogenous ALA concentrations.
Maltese: Fil-biċċa l-kbira tal-pazjenti, żieda ta' sa 2.5 darbiet tal-konċentrazzjonijiet fil-plażma ta' ALA bażiku, ġiet osservata matul l-ewwel 3 sigħat wara l-applikazzjoni ta' Ameluz, li xorta hi fil-medda normali tal konċentrazzjonijiet ALA endoġeni rrappurtati u ppubblikati qabel.
English: Illumination using daylight for actinic keratosis treatment If weather conditions are suitable (please see above; Considerations before treatment), you should go outside within 30 minutes after application of the gel and stay for 2 continuous hours in full daylight.
Maltese: Konsiderazzjonijiet qabel it-trattament), il-pazjenti għandhom imorru barra fi żmien 30 minuta wara l-applikazzjoni tal-ġell u joqgħodu għal sagħtejn sħaħ fid-dawl tax-xemx.
English: • reactions at the application site - skin reddening - pain (incl.
Maltese: • reazzjonijiet fis-sit tal-applikazzjoni - bidla fil-kulur - ponot
English: • St. John's wort.
Maltese: John's wort.
English: Absolute bioavailability has been estimated to be between 64 and 80 %.
Maltese: Il-bijodisponibilità assoluta kienet stmata li hi bejn 64 u 80 %.
English: Pregelatinised starch (prepared from maize starch) Sodium hydroxide
Maltese: Pregelatinised starch (ippreparat minn maize starch) Sodium hydroxide
English: 14 tablets 28 tablets 30 x 1 tablets 56 tablets 90 x 1 tablets 98 tablets
Maltese: 14-il pillola 28 pillola 30 x 1 pillola 56 pillola 90 x 1 pillola 98 pillola
English: Date of latest renewal: 20 August 2015
Maltese: Data tal-aħħar tiġdid: 20 ta' Awwissu, 2015
English: • Rifampicin, erythromycin, clarithromycin (antibiotics).
Maltese: • Rifampicin, erythromycin, clarithromycin (antibijotiċi).
English: Rottendorf Pharma GmbH Ostenfelder Straße 51 - 61 D-59320 Ennigerloh Germany
Maltese: Rottendorf Pharma GmbH Ostenfelder Straße 51 - 61 D-59320 Ennigerloh Il-Ġermanja
English: System Organ Class
Maltese: Sistema talKlassifika talOrgani tal-Organi
English: Rare visual disturbance
Maltese: Rari disturbi tal-vista
English: • Dantrolene (infusion for severe body temperature abnormalities).
Maltese: • Dantrolene (infużjoni għal anormalitajiet severi fit-temperatura tal-ġisem).
English: The reduction in diastolic blood pressure <90 mmHg was achieved in 71.6 %, 74.8 %, 82.1 %, 85.3 % of patients respectively.
Maltese: It-tnaqqis fil-pressjoni tad-demm dijastolika ta' <90 mmHg inkiseb f'71.6 %, 74.8 %, 82.1 %, 85.3 % tal-pazjenti rispettivament.
English: Twynsta contains sodium
Maltese: Twynsta fih sodium
English: Very rare extrapyramidal syndrome, hypertonia
Maltese: Rari ħafna sindrome extrapiramidali, ipertonija
English: Mechanistic Target of Rapamycin (mTOR) Inhibitors mTOR inhibitors such as sirolimus, temsirolimus, and everolimus are CYP3A substrates.
Maltese: Inibituri tal-Mira Mekkanika ta' Rapamycin (mTOR - Mechanistic Target of Rapamycin) Inibituri ta' mTOR bħal sirolimus, temsirolimus, u everolimus huma substrati ta' CYP3A.
English: Rare thrombocytopenia, eosinophilia
Maltese: Rari tromboċitopenija, eosinofilija
English: • The other ingredients are colloidal anhydrous silica, brilliant blue FCF (E133), ferric oxide black (E172), ferric oxide yellow (E172), magnesium stearate, maize starch, meglumine, microcrystalline cellulose, povidone K25, pregelatinized starch prepared from maize starch, sodium hydroxide, sorbitol (E420).
Maltese: - Is-sustanzi l-oħra huma colloidal anhydrous silica, brilliant blue FCF (E133), ferric oxide black (E172), ferric oxide yellow (E172), magnesium stearate, maize starch, meglumine, microcrystalline cellulose, povidone K25, pregelatinized starch ippreparat minn maize starch, sodium hydroxide, sorbitol (E420).
English: Telmisartan is largely bound to plasma protein (>99.5 %), mainly albumin and alpha-1 acid glycoprotein.
Maltese: Telmisartan fil-biċċa l-kbira tiegħu jeħel mal-proteini fil-plażma (>99.5 %), primarjament malalbumina u alpha-1 acid glycoprotein.
English: Amlodipine is extensively (approximatively 90 %) metabolised by the liver to inactive metabolites.
Maltese: Amlodipine jiġi metabolizzat b'mod estensiv (madwar 90 %) mill-fwied għal metaboliti inattivi.
English: PHARMACEUTICAL FORM AND CONTENTS 90 tablets
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT 90 pillola
English: Immune system disorders: Rare hypersensitivity, anaphylactic reaction
Maltese: Disturbi fis-sistema immuni: Rari sensittività eċċessiva, reazzjoni anafilattika
English: tendon pain (tendinitis like symptoms)
Maltese: Uġigħ fit-tendini (sintomi qishom tendinite)
English: “Warnings and precautions”).
Maltese: “Twissijiet u prekawzjonijiet”).
English: Very rare pancreatitis, gastritis
Maltese: Rari ħafna pankreatite, gastrite
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 7 October 2010
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 7 ta' Ottubru, 2010
English: Very rare angioedema, erythema multiforme, urticaria, exfoliative dermatitis, Stevens-Johnson syndrome, photosensitivity
Maltese: Rari ħafna anġjoedema, erithma multiforme, urtikarja, dermatite bil-qxur, sindrome ta' StevensJohnson, sensittività għad-dawl
English: See also “Do not take Twynsta”.
Maltese: Ara wkoll “Tiħux Twynsta”.
English: Rare cystitis sepsis including fatal outcome
Maltese: Rari ċistite sepsis li tinkludi riżultat fatali
English: The antihypertensive efficacy of telmisartan is comparable to that of substances representative of other classes of antihypertensive medicinal products (demonstrated in clinical trials comparing telmisartan to amlodipine, atenolol, enalapril, hydrochlorothiazide, and lisinopril).
Maltese: L-effikaċja anti-ipertensiva ta' telmisartan hi komparabbli ma' dik ta' mediċini li jirrappreżentaw kategoriji oħrajn ta' mediċini kontra l-pressjoni għolja (dan intwera fi provi kliniċi li qabblu telmisartan ma' amlodipine, atenolol, enalapril, hydrochlorothiazide, u lisinopril).
English: The mean absolute bioavailability for telmisartan is about 50 %.
Maltese: Il-medja talbijodisponibilità assoluta għal telmisartan hi ta' madwar 50 %.
English: Two large randomised, controlled trials (ONTARGET (ONgoing Telmisartan Alone and in combination with Ramipril Global Endpoint Trial) and VA NEPHRON-D (The Veterans Affairs Nephropathy in
Maltese: Żewġ provi kbar ikkontrollati li fihom il-parteċipanti ntgħażlu b'mod każwali, (ONTARGET (ONgoing Telmisartan Alone and in combination with Ramipril Global Endpoint Trial) u VA NEPHRON-D (The Veterans Affairs Nephropathy in Diabetes)) eżaminaw l-użu tal-kombinazzjoni ta' inibitur ta' ACE ma' imblokkaturi tar-riċetturi ta' angiotensin II.
English: Twynsta contains sorbitol This medicine contains 168.64 mg sorbitol in each tablet.
Maltese: Twynsta fih sorbitol Din il-mediċina fiha 168.64 mg ta' sorbitol f'kull pillola.
English: Twynsta is available in a folding box containing 14, 28, 56, 98 tablets in aluminium/aluminium blisters or containing 30 x 1, 90 x 1, 360 (4 x 90 x 1) tablets in aluminium/aluminium perforated unit dose blisters.
Maltese: Twynsta hu disponibbli f'kaxxa li tintewa li fiha 14, 28, 56, 98 pillola f'folji tal-aluminju/aluminju jew li fiha 30 x 1, 90 x 1, 360 (4 x 90 x 1) pillola f'folji perforati tal-aluminju/aluminju bl-unità taddoża.
English: In the factorial design trial the oedema rates were 1.3 % with Twynsta 40 mg/5 mg and 80 mg/5 mg, 8.8 % with Twynsta 40 mg/10 mg and 80 mg/10 mg and 18.4 % with Amlodipine 10 mg.
Maltese: Filprova factorial design, ir-rati ta' edema kienu 1.3 % bi Twynsta 40 mg/5 mg u 80 mg/5 mg, 8.8 % bi Twynsta 40 mg/10 mg u 80 mg/10 mg u 18.4 % b'Amlodipine 10 mg.
English: • Amlodipine belongs to a group of substances called “calcium channel blockers”.
Maltese: • Amlodipine jappartjeni għall-grupp ta' mediċini msejħa “imblokkaturi tal-kanal tal-calcium”.
English: When telmisartan was co-administered with digoxin, median increases in digoxin peak plasma concentration (49 %) and in trough concentration (20 %) were observed.
Maltese: Meta telmisartan kien mogħti flimkien ma' digoxin, ġew osservati żidiet medji fl-ogħla konċentrazzjonijiet fil-plażma (49 %) u fil-konċentrazzjonijiet l-aktar baxxi (20 %) ta' digoxin.
English: Rare depression, anxiety, insomnia confusion
Maltese: Rari depressjoni, ansjetà, nuqqas ta' rqad konfużjoni
English: The proportion of the maternal dose received by the infant has been estimated with an interquartile range of 3 - 7%, with a maximum of 15%.
Maltese: Il-proporzjon tad-doża materna li t-tarbija rċieviet ġiet stmata f'firxa interkwartili ta' 3 - 7%, b'massimu ta' 15%.
English: Clinical data are insufficient regarding the potential effect of amlodipine on fertility.
Maltese: M'hemmx data klinika suffiċjenti dwar l-effett potenzjali ta' amlodipine fuq il-fertilità.
English: Very rare myocardial infarction, arrhythmia, ventricular tachycardia, atrial fibrillation
Maltese: Rari ħafna infart mijokardjali, arritmija, takikardija ventrikulari, fibrillazzjoni atrijali
English: Medicinal products or therapeutic classes of medicinal products that may provoke hyperkalaemia are salt substitutes containing potassium, potassium-sparing diuretics, ACE inhibitors, angiotensin II receptor antagonists, non steroidal anti-inflammatory medicinal products (NSAIDs, including selective COX-2 inhibitors), heparin, immunosuppressives (cyclosporin or tacrolimus), and trimethoprim.
Maltese: Prodotti mediċinali jew klassijiet terapewtiċi ta' prodotti mediċinali li jistgħu jikkawżaw iperkalemija huma sostituti tal-melħ li fihom potassium, dijuretiċi li jisperjaw potassium, inibituri ta' ACE, antagonisti tarriċetturi ta' angiotensin II, mediċini mhux sterojdi kontra l-infjammazzjoni (NSAIDs, li jinkludu inibituri COX-2 selettivi), eparina, immunosoppressivi (cyclosporin jew tacrolimus) u trimethoprim.
English: Very rare vasculitis
Maltese: Rari ħafna vaskulite
English: Colloidal anhydrous silica Brilliant blue FCF (E133) Ferric oxide black (E172) Ferric oxide yellow (E172) Magnesium stearate
Maltese: Ferric oxide yellow (E172) Magnesium stearate
English: Eye disorders Common visual disturbance (including diplopia)
Maltese: Disturbi fl-għajnejn Komuni disturb fil-vista (inkluż vista doppja)
English: Twynsta is not recommended for use in patients with hereditary fructose intolerance (HFI).
Maltese: Twynsta mhux rakkomandat biex jintuża f'pazjenti b'intolleranza ereditarja għall-fructose (hereditary fructose intolerance, HFI).
English: The safety and tolerability of Twynsta has been evaluated in five controlled clinical studies with over 3,500 patients, over 2,500 of whom received telmisartan in combination with amlodipine.
Maltese: Is-sigurtà u tollerabilità ta' Twynsta ġew evalwati f'ħames studji kliniċi kkontrollati fuq iktar minn 3,500 pazjent, li iktar minn 2,500 minnhom irċivew telmisartan flimkien ma' amlodipine.
English: Twynsta contains sorbitol This medicine contains 337.28 mg sorbitol in each tablet.
Maltese: Twynsta fih sorbitol Din il-mediċina fiha 337.28 mg ta' sorbitol f'kull pillola.
English: Other antihypertensive agents acting on the renin-angiotensin-aldosterone system (RAAS) Clinical trial data has shown that dual blockade of the renin-angiotensin-aldosterone system (RAAS) through the combined use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren is associated with a higher frequency of adverse events such as hypotension, hyperkalaemia and decreased renal function (including acute renal failure) compared to the use of a single RAAS-acting agent (see sections 4.3, 4.4 and 5.1).
Maltese: Dejta mill-provi kliniċi wriet li imblokk doppju tas-sistema renin-angiotensin-aldosterone (RAAS) permezz tal-użu kombinat ta' inibituri ta' ACE, imblokkaturi tar-riċetturi ta' angiotensin II jew aliskiren hu assoċjat ma' frekwenza ogħla ta' avvenimenti avversi bħal pressjoni baxxa, iperkalemija u tnaqqis fil-funzjoni tal-kliewi (li tinkludi insuffiċjenza akuta tal-kliewi) meta mqabbla mal-użu ta' mediċina waħda li taġixxi fuq RAAS (ara sezzjonijiet 4.3, 4.4 u 5.1).
English: Very rare hypersensitivity
Maltese: Rari ħafna sensittività eċċessiva
English: Children and adolescents Twynsta is not recommended in children and adolescents up to the age of 18 years.
Maltese: Tfal u adolexxenti Twynsta mhuwiex rakkomandat fit-tfal u fl-adolexxenti sal-età ta' 18-il sena.
English: • Angiotensin II receptor antagonists.
Maltese: • Antagonisti tar-riċettur ta' angiotensin II.
English: In patients not controlled on amlodipine 5 mg the oedema rates were 4.4 % for 40 mg/5 mg and 80 mg/5 mg and 24.9 % for amlodipine 10 mg.
Maltese: F'pazjenti mhux ikkontrollati li kienu fuq amlodipine 5 mg, ir-rati ta' edema kienu ta' 4.4 % għal 40 mg/5 mg u 80 mg/5 mg u 24.9 % għal amlodipine 10 mg.
English: PHARMACEUTICAL FORM AND CONTENTS Multipack comprising 4 packs, each containing 90 x 1 tablets
Maltese: U KONTENUT Pakkett multiplu li fih 4 pakketti, li kull wieħed fih 90 x 1 pillola