FrancophonIA/ELRC3.0 huggingface dataset:
English: Primula root is the common name for the underground parts of the plant Primula veris L. and/or Primula elatior (L.) Hill.
Maltese: Għerq tal-primula huwa l-isem komuni għal parti taħt l-art tal-pjanta Primula veris L. u/jew Primula elatior (L.) Hill.
English: The HMPC conclusions only cover primula root preparations which are obtained by drying and comminuting (reducing into tiny pieces) the underground parts or using a technique to extract compounds by putting the plant material in a solvent (such as ethanol or methanol) to dissolve compounds and form a liquid extract.
Maltese: Il-konklużjonijiet tal-HMPC ikopru biss il-preparazzjonijiet tal-għerq tal-primula li huma maħduma billi jitnixxfu u jindaħnu (f'biċċiet żgħar) il-partijiet ta' taħt l-art jew bl-użu ta' teknika għall-estrazzjoni ta' komponenti billi tpoġġi l-materjali tal-pjanta f'solvent (bħall-etanol jew metanol) biex jinħallu lkomponenti u jiffurmaw estratt likwidu.
English: Some specific preparations may be used in children between 4 and 12 years of age.
Maltese: Xi preparazzjonijiet speċifiċi jistgħu jintużaw fi tfal li għandhom bejn 4 u 12-il sena.
English: Further information on the HMPC assessment of primula root medicines, including details of the Committee's conclusions, can be found under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Maltese: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: This means that, although there is insufficient evidence from clinical trials, the effectiveness of these herbal medicines is plausible and there is evidence that they have been used safely in this way for at least 30 years (including at least 15 years within the EU).
Maltese: Dan ifisser li, għalkemm m'hemmx biżżejjed evidenza minn provi kliniċi, l-effikaċja ta' dawn il-mediċini tal-ħxejjex hija plawżibbli u hemm evidenza li ilhom jintużaw b'mod sigur b'dan il-mod mill-inqas 30 sena (inkluż mill-inqas 15-il sena fl-UE).
English: Further information on the risks associated with these primula root medicines, including the appropriate precautions for their safe use, can be found in the monograph under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Maltese: Aktar informazzjoni dwar ir-riskji assoċjati ma' dawn il-mediċini li fihom l-għerq tal-primula, inklużi lprekawzjonijiet xierqa għall-użu sigur tagħhom, tinsab fil-monografija taħt it-tab ‘Id-dokumenti kollha' (‘All Documents') fil-websajt tal-Aġenzija:
English: Most primula root preparations should only be used in adults and adolescents over the age of 12 years.
Maltese: Ħafna mill-preparazzjonijiet tal-għerq tal-primula għandhom jintużaw biss fl-adulti u fl-adolexxenti li għandhom 'il fuq minn 12-il sena.
English: What are the risks associated with primula root medicines?
Maltese: X'inhuma r-riskji assoċjati mal-mediċini tal-għerq tal-primula?
English: What is primula root?
Maltese: X'inhu l-għerq tal-primula?
English: In its assessment, the HMPC considered laboratory studies which showed primula root increased production of airway secretions, making phlegm less thick and easier to expel.
Maltese: Ir-riproduzzjoni hija awtorizzata kemm-il darba jissemma' s-sors oriġinali.
English: Herbal medicines containing these primula root preparations are usually available as herbal tea to be drunk and in liquid or solid forms to be taken by mouth.
Maltese: Il-mediċini tal-ħxejjex li fihom dawn il-preparazzjonijiet tal-għerq tal-primula normalment ikunu disponibbli bħala te tal-ħxejjex biex jinxtorob u f'għamla solida jew għamla likwida li għandha tittieħed mill-ħalq.
English: Other possible side effects of Exforge:
Maltese: Effetti sekondarji possibli oħra ta' Exforge:
English: Frequency Exforge Amlodipine Valsartan
Maltese: Frekwenza Exforge Amlodipine Valsartan
English: Age, gender, race or body mass index (≥30 kg/m 2, <30 kg/m 2) did not influence the response to
Maltese: L-età, sess, razza jew l-indiċi tal-massa tal-ġisem (≥30 kg/m2, <30 kg/m2) ma kellhomx effett fuq ir rispons għal Exforge.
English: The safety of Exforge has been evaluated in five controlled clinical studies with 5,175 patients, 2,613 of whom received valsartan in combination with amlodipine.
Maltese: Is-sigurtà ta' Exforge ġiet meqjusa f'ħames studji kliniċi kontrollati b'5,175 pazjent, li 2,613 minnhom irċevew valsartan kombinat ma' amlodipine.
English: See also information under the heading “Do not take Exforge”.
Maltese: Ara wkoll l-informazzjoni taħt l-intestatura “Tiħux Exforge”.
English: After the transitional period of 2 years, a limit for NDMA of maximum 0.03 ppm should be implemented.
Maltese: Wara l-perjodu tranżitorju ta' sentejn, għandu jiġi implimentat limitu għall-NDMA ta' massimu ta' 0.03 ppm.
English: Hypromellose, substitution type 2910 (3 mPa.s) Titanium dioxide (E171) Iron oxide, yellow (E172) Iron oxide, red (E172)
Maltese: Hypromellose, sostituzzjoni tip 2910 (3 mPa.s) Titanium dioxide (E171) Iron oxide, yellow (E172) Iron oxide, red (E172)
English: Hypromellose, substitution type 2910 (3 mPa.s) Titanium dioxide (E171) Iron oxide, yellow (E172) Macrogol 4000
Maltese: Hypromellose, sostituzzjoni tip 2910 (3 mPa.s) Titanium dioxide (E171) Iron oxide, yellow (E172) Macrogol 4000
English: • Concomitant use of Exforge with aliskiren-containing products in patients with diabetes mellitus or renal impairment (GFR <60 ml/min/1.73 m2) (see sections 4.5 and 5.1).
Maltese: • L-użu fl-istess ħin ta' Exforge ma' prodotti li jkun fihom aliskiren f'pazjenti b'dijabete mellitus jew indeboliment tal-kliewi (GFR <60 ml/min/1.73 m2) (ara sezzjonijiet 4.5 u 5.1).
English: In this study (baseline blood pressure 171/113 mmHg), an Exforge regimen of 5 mg/160 mg titrated to 10 mg/160 mg reduced sitting blood pressure by 36/29 mmHg as compared to 32/28 mmHg with a regimen of lisinopril/hydrochlorothiazide 10 mg/12.5 mg titrated to 20 mg/12.5 mg.
Maltese: F'dan l-istudju (il-linja bażi tal-pressjoni taddemm kienet 171/113 mmHg), b'reġimen ta' Exforge ta' 5 mg/160 mg miżjuda għal 10 mg/160 mg naqqset il-pressjoni tad-demm ta' bilqiegħeda b'36/29 mmHg meta imqabbla ma' 32/28 mmHg b'reġimen ta' lisinopril/hydrochlorthiazide 10 mg/12.5 mg miżjuda għal 20 mg/12.5 mg.
English: Date of first authorisation: 17 January 2007 Date of latest renewal: 22 November 2011
Maltese: Data tal-aħħar tiġdid: 22 Novembru 2011
English: Exforge 5 mg/80 mg film-coated tablets Exforge 5 mg/160 mg film-coated tablets Exforge 10 mg/160 mg film-coated tablets
Maltese: IL-PRODOTT MEDIĊINALI Exforge 5 mg/80 mg pilloli miksija b'rita Exforge 5 mg/160 mg pilloli miksija b'rita Exforge 10 mg/160 mg pilloli miksija b'rita
English: The other ingredients are cellulose microcrystalline; crospovidone (type A); silica, colloidal anhydrous; magnesium stearate; hypromellose (substitution type 2910 (3 mPa.s)); macrogol 4000; talc, titanium dioxide (E171); iron oxide, yellow (E172).
Maltese: Is-sustanzi l-oħra huma cellulose microcrystalline; crospovidone (type A); silica, colloidal anhydrous; magnesium stearate; hypromellose (sostituzzjoni tip 2910 (3 mPa.s)); macrogol 4000; talc, titanium dioxide (E171); iron oxide, yellow (E172).
English: The other ingredients are cellulose microcrystalline; crospovidone (type A); silica, colloidal anhydrous; magnesium stearate; hypromellose (substitution type 2910 (3 mPa.s)); macrogol 4000; talc, titanium dioxide (E171); iron oxide, yellow (E172), iron oxide, red (E172).
Maltese: Is-sustanzi l-oħra huma cellulose microcrystalline; crospovidone (type A); silica, colloidal anhydrous; magnesium stearate; hypromellose (sostituzzjoni tip 2910 (3 mPa.s)); macrogol 4000; talc, titanium dioxide (E171); iron oxide, yellow (E172), iron oxide, red (E172).
English: The active substances of Exforge are amlodipine (as amlodipine besylate) and valsartan.
Maltese: Is-sustanzi attivi ta' Exforge huma amlodipine(bħala amlodipine besylate) u valsartan.
English: Not known Decrease in haemoglobin, decrease in haematocrit, neutropenia, thrombocytopenia, increase of serum potassium, elevation of liver function values including increase of serum bilirubin, renal failure and impairment, elevation of serum creatinine, angioedema, myalgia, vasculitis, hypersensitivity including serum sickness.
Maltese: Tnaqqis fl-emoglobina, tnaqqis fl-ematocrit, newtropenja, tromboċitopenja, żieda filpotassju tas-serum, żieda fil-valuri tal-funzjoni tal-fwied inkluż żieda fil-bilirubin tasserum, insuffiċjenza u indeboliment tal-kliewi, livell ogħla ta' kreatinina fis-serum, anġjoedima, majalġja, vaskulite, sensittività eċċessiva inkluż mard tas-serum.
English: How to store Exforge
Maltese: X'fih Exforge
English: Exforge 5 mg/80 mg film-coated tablets Exforge 5 mg/160 mg film-coated tablets Exforge 10 mg/160 mg film-coated tablets amlodipine/valsartan
Maltese: Exforge 5 mg/80 mg pilloli miksija b'rita Exforge 5 mg/160 mg pilloli miksija b'rita Exforge 10 mg/160 mg pilloli miksija b'rita amlodipine/valsartan
English: No dosage adjustment of Exforge is required for patients with mild to moderate renal impairment (GFR >30 ml/min/1.73 m2).
Maltese: M'hemmx bżonn ta' tibdil fid-dożaġġ għall-pazjenti li għandhom indeboliment ħafif għal moderat (GFR >30 ml/min/1.73 m2).
English: Exforge is available in packs containing 7, 14, 28, 30, 56, 90, 98 or 280 tablets and in multipacks comprising 4 cartons, each containing 70 tablets, or 20 cartons, each containing 14 tablets.
Maltese: Exforge jiġi f'pakketti li jkun fihom 7, 14, 28, 30, 56, 90, 98 jew 280 pillola u pakketti b'ħafna li jinkludu 4 kartuniet, kull wieħed fih 70 pillola, jew 20 kartuna, kull waħda b'14 -il pillola.
English: Other medicines and Exforge
Maltese: Mediċini oħra u Exforge
English: Exforge 10 mg/160 mg tablets are oval and light yellow with “NVR” on one side and “UIC” on the other side.
Maltese: Exforge 10 mg/160 mg pilloli huma ovali u sofor ċari b' “NVR” fuq naħa u “UIC” fuq in-naħa l-oħra.
English: Exforge 5 mg/160 mg tablets are oval and dark yellow “NVR” on one side and “ECE” on the other side.
Maltese: Exforge 5 mg/160 mg pilloli huma ovali u sofor skuri b' “NVR” fuq naħa u “ECE” fuq in-naħa l-oħra.
English: Musculoskeletal and connective tissue disorders
Maltese: Disturbi muskoluskelet-triċi u tat-tessuti konnettivi
English: Do not take Exforge with grapefruit or grapefruit juice.
Maltese: Tiħux Exforge ma' grejpfrut jew ma' meraq tal-grejpfrut.
English: Following intravenous administration, plasma clearance of valsartan is about 2 l/h and its renal clearance is 0.62 l/h (about 30% of total clearance).
Maltese: Wara li jingħata ġol-vina, it-tneħħija ta' valsartan minn ġol-plażma hija madwar 2 l/h u t-tneħħija renali hija 0.62 l/h (madwar 30% tat-tneħħija totali).
English: Uncommon Insomnia, mood changes (including anxiety), depression, tremor, dysgeusia, syncope, hypoesthesia, visual disturbance (including diplopia), tinnitus, hypotension, dyspnoea, rhinitis, vomiting, dyspepsia, alopecia, purpura, skin discolouration, hyperhidrosis, pruritus, exanthema, myalgia, muscle cramps, pain, micturition disorder, increased urinary frequency, impotence, gynaecomastia, chest pain, malaise, weight increase, weight decrease.
Maltese: Mhux komuni Nuqqas ta' rqad, bidliet fil-burdata (fosthom ansjetà), dipressjoni, tregħid, disgewżja, sinkope, ipoestesija, disturb viżwali (fosthom diplopja), żanżin tal-widnejn, pressjoni baxxa, dispneja, rinite, rimettar, dispepsja, alopeċja, purpura, tidnis tal-ġilda, iperidrosi, ħakk, exanthema, uġigħ fil-muskoli, bugħawwieġ fil-muskoli, uġigħ, disturb fl-għamil tal-awrina, żieda fil-frekwenza tal-awrina, impotenza, ginekomastja, uġigħ fis-sider, astenja, żieda fil-piż, tnaqqis fil-piż.
English: Exforge 5 mg/80 mg film-coated tablets amlodipine/valsartan
Maltese: Exforge 5 mg/80 mg pilloli miksija b'rita amlodipine/valsartan
English: Exforge 10 mg/160 mg film-coated tablets amlodipine/valsartan
Maltese: Exforge 10 mg/160 mg pilloli miksija b'rita amlodipine/valsartan
English: Valsartan belongs to a group of substances called “angiotensin-II receptor antagonists”.
Maltese: - Valsartan huwa membru ta' grupp ta' sustanzi li jissejħu “antagonisti tar-riċetturi ta' angiotensin
English: 70 film-coated tablets.
Maltese: 70-il pillola miksija b'rita.
English: Following oral administration of Exforge, peak plasma concentrations of valsartan and amlodipine are reached in 3 and 6-8 hours, respectively.
Maltese: Wara li Exforge jittieħed mill-ħalq l-ogħla konċentrazzjonijiet fil-plażma ta' valsartan u amlodipine jintlaħqu fi 3 u 6-8 sigħat, rispettivament.
English: Exforge 5 mg/160 mg film-coated tablets amlodipine/valsartan
Maltese: Exforge 5 mg/160 mg pilloli miksija b'rita amlodipine/valsartan
English: The no-observed-effect-level for developmental effects was observed at 3- (valsartan) and 4- (amlodipine) fold the clinical exposure (based on AUC).
Maltese: Il-livell fejn ma jidhirx effett għall-effetti tal-iżvilupp kien osservat b'3- (valsartan) u 4-(amlodipine) darbiet l-esponiment kliniku (bażat fuq lAUC).
English: Exposure to AIIRA therapy during the second and third trimesters is known to induce human foetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia) (see section 5.3).
Maltese: Espożizzjoni għall-kura ta' AIIRA fit-tieni u it-tielet trimestri huwa magħruf li jinduċi tossiċità tal-fetu uman (funzjoni renali mnaqqsa, oligoidramnios, ittardjar tal-ossifikazzjoni tal-kranju) u tossiċità fittrabi wara it-twelid (indeboliment renali, pressjoni baxxa, iperkalemia)
English: Exforge was also studied in an active-controlled study of 130 hypertensive patients with mean sitting diastolic blood pressure ≥110 mmHg and <120 mmHg.
Maltese: Exforge kien studjat ukoll fi studju kkontrollat bl-attiv ta' 130 pazjent bi pressjoni għolja bil-pressjoni dijastolika bilqiegħda medja ≥110 mmHg u <120 mmHg.
English: Valsartan works by blocking the effect of angiotensin II.
Maltese: Valsartan jaħdem billi jimblokka l-effett ta' angiotensin II.
English: EU/1/06/370/009 7 film-coated tablets EU/1/06/370/010 14 film-coated tablets EU/1/06/370/011 28 film-coated tablets EU/1/06/370/012 30 film-coated tablets EU/1/06/370/013 56 film-coated tablets EU/1/06/370/014 90 film-coated tablets EU/1/06/370/015 98 film-coated tablets EU/1/06/370/016 280 film-coated tablets EU/1/06/370/028 56x1 film-coated tablet (unit dose) EU/1/06/370/029 98x1 film-coated tablet (unit dose) EU/1/06/370/030 280x1 film-coated tablet (unit dose)
Maltese: EU/1/06/370/009 7 pilloli miksija b'rita EU/1/06/370/010 14-il pillola miksija b'rita EU/1/06/370/011 28 pillola miksija b'rita EU/1/06/370/012 30 pillola miksija b'rita EU/1/06/370/013 56 pillola miksija b'rita EU/1/06/370/014 90 pillola miksija b'rita EU/1/06/370/015 98 pillola miksija b'rita EU/1/06/370/016 280 pillola miksija b'rita EU/1/06/370/028 56xpillola 1 miksija b'rita (doża waħda)
English: EU/1/06/370/017 7 film-coated tablets EU/1/06/370/018 14 film-coated tablets EU/1/06/370/019 28 film-coated tablets EU/1/06/370/020 30 film-coated tablets EU/1/06/370/021 56 film-coated tablets EU/1/06/370/022 90 film-coated tablets EU/1/06/370/023 98 film-coated tablets EU/1/06/370/024 280 film-coated tablets EU/1/06/370/031 56x1 film-coated tablet (unit dose) EU/1/06/370/032 98x1 film-coated tablet (unit dose) EU/1/06/370/033 280x1 film-coated tablet (unit dose)
Maltese: EU/1/06/370/017 7 pilloli miksija b'rita EU/1/06/370/018 14-il pillola miksija b'rita EU/1/06/370/019 28 pillola miksija b'rita EU/1/06/370/020 30 pillola miksija b'rita EU/1/06/370/021 56 pillola miksija b'rita EU/1/06/370/022 90 pillola miksija b'rita EU/1/06/370/023 98 pillola miksija b'rita EU/1/06/370/024 280 pillola miksija b'rita EU/1/06/370/031 56xpillola 1 miksija b'rita (doża b'waħda) EU/1/06/370/032 98xpillola 1 miksija b'rita (doża b'waħda) EU/1/06/370/033 280xpillola 1 miksija b'rita (doża b'waħda)
English: EU/1/06/370/001 7 film-coated tablets EU/1/06/370/002 14 film-coated tablets EU/1/06/370/003 28 film-coated tablets EU/1/06/370/004 30 film-coated tablets EU/1/06/370/005 56 film-coated tablets EU/1/06/370/006 90 film-coated tablets EU/1/06/370/007 98 film-coated tablets EU/1/06/370/008 280 film-coated tablets EU/1/06/370/025 56x1 film-coated tablet (unit dose) EU/1/06/370/026 98x1 film-coated tablet (unit dose) EU/1/06/370/027 280x1 film-coated tablet (unit dose)
Maltese: EU/1/06/370/001 7 pilloli miksija b'rita EU/1/06/370/002 14-il pillola miksija b'rita EU/1/06/370/003 28 pillola miksija b'rita EU/1/06/370/004 30 pillola miksija b'rita EU/1/06/370/005 56 pillola miksija b'rita EU/1/06/370/006 90 pillola miksija b'rita EU/1/06/370/007 98 pillola miksija b'rita EU/1/06/370/008 280 pillola miksija b'rita EU/1/06/370/025 56xpillola 1 miksija b'rita (doża waħda)
English: Hepatic impairment Exforge is contraindicated in patients with severe hepatic impairment (see section 4.3).
Maltese: Indeboliment tal-fwied Exforge huwa kontra-indikat f'pazjenti b'indeboliment tal-fwied qawwi (ara sezzjoni 4.3).
English: Valsartan does not exhibit any partial agonist activity at the AT1 receptor and has much (about 20,000-fold) greater affinity for the AT1 receptor than for the AT2 receptor.
Maltese: Valsartan ma jidhirx li għandu effett parzjali ta' agonist tarriċettur AT1 u għandu affinità ħafna akbar (b'madwar 20,000 darba) għar-riċettur AT1 milli għarriċettur AT2.
English: EU/1/06/370/017 EU/1/06/370/018 EU/1/06/370/019 EU/1/06/370/020 EU/1/06/370/021 EU/1/06/370/022 EU/1/06/370/023 EU/1/06/370/024 EU/1/06/370/031 EU/1/06/370/032 EU/1/06/370/033 EU/1/06/370/036 EU/1/06/370/039
Maltese: EU/1/06/370/031 EU/1/06/370/032 EU/1/06/370/033 EU/1/06/370/036 EU/1/06/370/039
English: Excessive hypotension was seen in 0.4% of patients with uncomplicated hypertension treated with Exforge in placebo-controlled studies.
Maltese: Pressjoni baxxa eċċessiva dehret f'0.4% tal-pazjenti b'pressjoni għolja mingħajr kumplikazzjonijiet li kienet kurata b'Exforge fi studji kontrollati bi plaċebo.
English: EU/1/06/370/034 280 film-coated tablets (4x70) EU/1/06/370/037 280 film-coated tablets (20x14)
Maltese: EU/1/06/370/037 280 pillola miksija b'rita (20x14)
English: Exforge 10 mg/160 mg may be administered in patients whose blood pressure is not adequately controlled with amlodipine 10 mg or valsartan 160 mg alone or with Exforge 5 mg/160 mg.
Maltese: Exforge 10 mg/160 mg jista' jingħata lill-pazjenti li ma jkollhomx pressjoni kontrollata tajjeb b'amlodipine 10 mg jew valsartan 160 mg waħidhom jew b'Exforge 5 mg/160 mg.
English: Exforge 5 mg/80 mg film-coated tablets
Maltese: Exforge 5 mg/80 mg pilloli miksija b'rita
English: EU/1/06/370/001 EU/1/06/370/002 EU/1/06/370/003 EU/1/06/370/004 EU/1/06/370/005 EU/1/06/370/006 EU/1/06/370/007 EU/1/06/370/008 EU/1/06/370/025 EU/1/06/370/026 EU/1/06/370/027 EU/1/06/370/034 EU/1/06/370/037
Maltese: EU/1/06/370/001 EU/1/06/370/002 EU/1/06/370/003 EU/1/06/370/004
English: What Exforge looks like and contents of the pack Exforge 5 mg/80 mg tablets are round and dark yellow with “NVR” on one side and “NV” on the other side.
Maltese: Exforge 5 mg/80 mg pilloli huma tondi u sofor skuri b' “NVR” fuq naħa u “NV” fuq in-naħa l-oħra.
English: EU/1/06/370/035 280 film-coated tablets (4x70) EU/1/06/370/038 280 film-coated tablets (20x14)
Maltese: EU/1/06/370/038 280 pillola miksija b'rita (20x14)
English: EU/1/06/370/036 280 film-coated tablets (4x70) EU/1/06/370/039 280 film-coated tablets (20x14)
Maltese: EU/1/06/370/039 280 pillola miksija b'rita (20x14)
English: Reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with angiotensin converting enzyme inhibitors or angiotensin II receptor antagonists, including valsartan.
Maltese: Żiediet riversibbli tal-konċentrazzjonijiet ta' lithium fis-serum u tossiċità kienu rappurtati waqt li lithium kien qiegħed jingħata flimkien mal-inibituri tal-enzima li tibdel angiotensin jew antagonisti tarriċettur ta' anġjotensin II, inkluż valsartan.
English: Uncommon (may affect up to 1 in 100 people): Mood changes, anxiety, depression, sleeplessness, trembling, taste abnormalities, fainting, loss of pain sensation; visual disturbances, visual impairment, ringing in the ears; low blood pressure; sneezing/runny nose caused by inflammation of the lining of the nose (rhinitis); indigestion, vomiting (being sick); hair loss, increased sweating, itchy skin, skin discolouration; disorder in passing urine, increased need to urinate at night, increased number of times of passing urine; inability to obtain an erection, discomfort or enlargement of the breasts in men, pain, feeling unwell, muscle pain, muscle cramps; weight increase or decrease.
Maltese: Bidliet fil-burdata, ansjetà, dipressjoni, nuqqas ta' rqad, rogħda, togħma abnormali, ħass ħażin, telf tas-sensazzjoni tal-uġigħ; disturbi viżwali, nuqqas ta' vista, żanżin fil-widnejn; pressjoni baxxa tad-demm; għatis/imnieħer iqattar ikkawżati minn infjammazzjoni fir-rita tal-imnieħer (rinite); indiġestjoni, rimettar (tkun imdardar); twaqqigħ tax-xagħar, żieda fl-għaraq, ġilda tieklok, tidnis tal-ġilda; disturb biex tagħmel l-awrina, żieda fil-bżonn li tagħmel l-awrina billejl, żieda fin-numru ta' drabi li tagħmel l-awrina; nuqqas ta' kapaċità li jkollok erezzjoni, skonfort jew tkabbir tas-sider fl-irġiel, uġigħ, tħossok ma tiflaħx, uġigħ fil-muskoli, bugħawwieġ fil-muskoli; żieda jew tnaqqis fil-piż.
English: Very rare (may affect up to 1 in 10,000 people): Decreased number of white blood cells, decrease in blood platelets which may result in unusual brusing or easy bleeding (red blood cell damage); excess sugar in blood (hyperglycaemia); swelling of the gums, abdominal bloating (gastritis); abnormal liver function, inflammation of the liver (hepatitis), yellowing of the skin (jaundice), liver enzyme increase which may have an effect on some medical tests; increased muscle tension; inflammation of blood vessels often with skin rash, sensitivity to light; disorders combining rigidity, tremor and/or movement disorders.
Maltese: Tnaqqis fin-numru ta' ċelloli bojod tad-demm, tnaqqis fin-numru ta' plejtlits fid-demm li jista' jwassal għal tbenġil mhux tas-soltu jew fsada malajr (ħsara fiċ-ċelloli ħomor tad-demm); zokkor żejjed fid-demm (ipergliċemija); nefħa filħanek, nefħa addominali (gastrite); funzjoni abnormali tal-fwied, infjammazzjoni tal-fwied (epatite), sfura fil-ġilda (suffejra), żieda fl-enzimi tal-fwied li jista' jkolIha effett fuq xi testijiet mediċi; żieda fittensjoni tal-muskoli; infjammazzjoni fil-vini u l-arterji, ħafna drabi b'raxx fil-ġilda, sensittività għaddawl; disturbi li jikkombinaw riġidità, rogħda, u/jew disturbi fil-moviment.
English: Exforge 5 mg/160 mg film-coated tablets
Maltese: Exforge 5 mg/160 mg pilloli miksija b'rita
English: Cardiovascular death and stroke were both numerically more frequent in the aliskiren group than in the placebo group and adverse events and serious adverse events of interest (hyperkalaemia, hypotension and renal dysfunction) were more frequently reported in the aliskiren group than in the placebo group.
Maltese: Mewt kardjovaskulari u puplesija t-tnejn kienu numerikament iktar frekwenti fil-grupp ta' aliskiren milli fil-grupp talplaċebo, u avvenimenti avversi u avvenimenti avversi serji ta' interess (iperkalimja, pressjoni baxxa u disfunzjoni tal-kliewi) ġew irrappurtati b'mod iktar frekwenti fil-grupp ta' aliskiren milli fil-grupp talplaċebo.
English: Exforge 10 mg/160 mg film-coated tablets
Maltese: Exforge 10 mg/160 mg pilloli miksija b'rita
English: The highest dose (for mice, similar to, and for rats twice* the maximum recommended clinical dose of 10 mg on a mg/m basis) was close to the maximum tolerated dose for mice but not for rats.
Maltese: L-ogħla doża (għall-ġrieden, simili għal, u għall-firien id-doppju* tad-doża klinika massima rakkomandata ta' 10 mg fuq bażi ta' mg/m2) kienet simili għad-doża massima ttollerata għallġrieden iżda mhux għall-firien.
English: The amlodipine component of Exforge inhibits the transmembrane entry of calcium ions into cardiac and vascular smooth muscle.
Maltese: Il-komponent amlodipine f'Exforge jinibixxi id-dħul mill-membrana ta' joni ta' calcium fil-muskoli talqalb u tal-muskoli lixxi tal-vini.