FrancophonIA/ELRC3.0 huggingface dataset:
English: EU/1/98/089/001 EU/1/98/089/002 EU/1/98/089/021 EU/1/98/089/003 EU/1/98/089/017 EU/1/98/089/004 EU/1/98/089/005 EU/1/98/089/015
Maltese: EU/1/98/089/001 EU/1/98/089/002 EU/1/98/089/021 EU/1/98/089/003 EU/1/98/089/017 EU/1/98/089/004
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 l-iperkalemija huma sostituti tal-melħ li fihom il-potassium, dijuretiċi li ma jneħħux potassium, inibituri ta' ACE, antagonisti tar-riċettur ta' angiotensin II, prodotti mediċinali mhux sterojdi kontra l-infjammazzjoni (NSAIDs, li jinkludu inibituri COX-2 selettivi), eparina, immunosoppressuri (cyclosporin jew tacrolimus), u trimethoprim.
English: How to store Pritor
Maltese: X'fih Pritor
English: Bayer AG Kaiser-Wilhelm-Allee 51368 Leverkusen Germany
Maltese: Bayer AG 51368 Leverkusen
English: Each tablet contains 40 mg telmisartan.
Maltese: Kull pillola fiha 40 mg telmisartan.
English: Telmisartan displaces angiotensin II with very high affinity from its binding site at the AT1 receptor subtype, which is responsible for the known actions of angiotensin II.
Maltese: Telmisartan jieħu post angiotensin II b'affinità għolja ħafna mis-sit fejn jeħel fissottotip tar-riċettur AT1, li hu responsabbli għall-azzjonijiet magħrufa ta' angiotensin II.
English: Very rare side effects (may affect up to 1 in 10,000 people): Progressive scarring of lung tissue (interstitial lung disease)**.
Maltese: Ċikatriċi progressivi ta' tessut tal-pulmun (mard interstizjali tal-pulmun)**
English: Dual blockade of RAAS through the combined use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren is therefore not recommended (see sections 4.5 and 5.1).
Maltese: imblokkaturi tar-riċetturi ta' angiotensin II jew aliskiren għalhekk mhuwiex rakkomandat (ara sezzjonijiet 4.5 u 5.1).
English: EU/1/98/089/011 EU/1/98/089/012 EU/1/98/089/020 EU/1/98/089/013 EU/1/98/089/019 EU/1/98/089/014
Maltese: EU/1/98/089/011 EU/1/98/089/012 EU/1/98/089/020
English: Hepatic function abnormal/liver disorder Skin and subcutaneous tissue disorders Uncommon: Rare:
Maltese: Funzjoni epatika anormali/disturb fil-fwied Disturbi fil-ġilda u fit-tessuti ta' taħt il-ġilda Mhux komuni: Rari:
English: As with other medicinal products acting on the renin-angiotensin-aldosterone system, telmisartan may provoke hyperkalaemia (see section 4.4).
Maltese: Bħal prodotti mediċinali oħrajn li jaġixxu fuq is-sistema renin-angiotensin-aldosterone, telmisartan jista' jikkawża l-iperkalemija (ara sezzjoni 4.4).
English: Abdominal pain, diarrhoea, dyspepsia, flatulence, vomiting Dry mouth, stomach discomfort, dysgeusia
Maltese: Uġigħ addominali, dijarea, dispepsja, gass, rimettar Ħalq xott, skonfort fl-istonku, tibdil fis-sens tat-togħma
English: The listing also takes into account serious adverse reactions and adverse reactions leading to discontinuation reported in three clinical long-term studies including 21642 patients treated with telmisartan for the reduction of cardiovascular morbidity for up to six years.
Maltese: Il-lista tikkunsidra wkoll reazzjonijiet avversi serji u reazzjonijiet avversi li jwasslu għal twaqqif tal-mediċina rrappurtat fi tliet studji kliniċi fit-tul li kienu jinkludu 21642 pazjent ikkurati b'telmisartan għat-tnaqqis ta' morbożità kardjovaskulari għal sa sitt snin.
English: Renal impairment
Maltese: Indeboliment renali u trapjant renali
English: Respiratory, thoracic and mediastinal disorders Uncommon:
Maltese: Disturbi respiratorji, toraċiċi u medjastinali Mhux komuni:
English: NAME OF THE MEDICINAL PRODUCT Pritor 40 mg tablets telmisartan
Maltese: Informazzjoni għall-utent Pritor 40 mg pilloli Telmisartan
English: The mean steady state apparent volume of distribution (Vdss) is approximately 500 l.
Maltese: Il-medja ta' l-istat fiss apparenti tal-volum tad-distribuzzjoni (Vdss) hija ta' madwar 500 l.
English: VA NEPHRON-D was a study in patients with type 2 diabetes mellitus and diabetic nephropathy.
Maltese: VA NEPHRON-D kien studju f'pazjenti b'dijabete mellitus ta' tip 2 u nefropatija dijabetika.
English: The patient should be closely monitored, and the treatment should be symptomatic and supportive.
Maltese: Il-pazjent għandu jkun immonitorjat mill-qrib, u lkura għandha tkun sintomatika u ta' appoġġ.
English: Pritor 80 mg tablets White oblong tablets of 4.6 mm engraved with the code number '52H' on one side.
Maltese: Pilloli bojod ta' 4.6 mm b'forma oblunga li fuqhom hemm imnaqqax in-numru tal-kodiċi ‘52H' fuq naħa waħda.
English: The use of angiotensin II receptor antagonists is contraindicated during the second and third trimesters of pregnancy (see sections 4.3 and 4.4).
Maltese: L-użu ta' antagonisti tar-riċetturi ta' angiotensin II hu kontra-indikat matul ittieni u t-tielet trimestru tat-tqala (ara sezzjonijiet 4.3 u 4.4).
English: The maximum plasma concentration (Cmax) and, to a smaller extent, the area under the plasma concentration-time curve (AUC), increase disproportionately with dose.
Maltese: L-ogħla konċentrazzjoni fil-plażma (Cmax) u, fi grad anqas, iżżona taħt il-kurva ta' konċentrazzjoni fil-plażma-ħin (AUC), jiżdiedu b'mod sproporzjonat mad-doża.
English: Haemoglobin decreased, blood uric acid increased, hepatic enzyme increased, blood creatine phosphokinase increased,
Maltese: Tnaqqis fl-emoglobina, żieda fil-uric acid fid-demm, żieda flenzimi epatiċi, żieda fil-creatine phosphokinase fid-demm
English: What Pritor looks like and contents of the pack Pritor 40 mg tablets are white, oblong-shaped and engraved with the code '51H' on one.
Maltese: Il-pilloli Pritor 40 mg huma bojod, b'forma oblunga u mnaqqxa bin-numru tal-kodiċi ‘51H' fuq naħa waħda.
English: This is confirmed by trough to peak ratios consistently above 80 % seen after doses of 40 and 80 mg of telmisartan in placebo controlled clinical studies.
Maltese: Dan hu kkonfermat mill-proporzjonijiet bejn il-livelli l-aktar baxxi imqabbla ma' l-ogħla livelli, li kienu aktar minn 80% b'mod konsistenti, osservati wara li ngħataw dożi ta' 40 u 80 mg ta' telmisartan fi provi kliniċi b'telmisartan ikkontrollati bi plaċebo.
English: Pruritus, hyperhidrosis, , rash Angioedema (also with fatal outcome), eczema, erythema, urticaria, drug eruption, toxic skin eruption
Maltese: Anġjoedema (ukoll b'riżultat fatali), ekżema, eritema, urtikarja, eruzzjoni minħabba l-mediċina, eruzzjoni tossika tal-ġilda
English: In both species, increased plasma renin activity and hypertrophy/hyperplasia of the renal juxtaglomerular cells were observed.
Maltese: Fiż-żewġ speċi, żieda fl-attività tar-renin fil-plażma u ipertrofija/iperplasija taċ-ċelluli juxtaglomerular kienet osservata.
English: EU/1/98/089/006 (14 tablets) EU/1/98/089/007 (28 tablets) EU/1/98/089/022 (30 tablets) EU/1/98/089/008 (56 tablets) EU/1/98/089/018 (90 tablets) EU/1/98/089/009 (98 tablets) EU/1/98/089/010 (280 tablets) EU/1/98/089/016 (28 x 1 tablets)
Maltese: Pritor 80 mg pilloli EU/1/98/089/006 (14-il pillola) EU/1/98/089/007 (28 pillola) EU/1/98/089/022 (30 pillola) EU/1/98/089/008 (56 pillola) EU/1/98/089/018 (90 pillola) EU/1/98/089/009 (98 pillola) EU/1/98/089/010 (280 pillola) EU/1/98/089/016 (28 x 1 pillola)
English: Insomnia, depression, Anxiety
Maltese: Nuqqas ta' rqad, dipressjoni
English: Each tablet contains 20 mg telmisartan.
Maltese: Kull pillola fiha 20 mg telmisartan.
English: NAME OF THE MEDICINAL PRODUCT Pritor 80 mg tablets telmisartan
Maltese: Informazzjoni għall-utent Pritor 80 mg pilloli Telmisartan
English: The main risk factors for hyperkalaemia to be considered are: - Diabetes mellitus, renal impairment, age (>70 years) - Combination with one or more other medicinal products that affect the renin-angiotensinaldosterone system and/or potassium supplements.
Maltese: - Dijabete mellitus, indeboliment renali, età (> 70 sena) - Kumbinazzjoni ma' prodott mediċinali wieħed jew aktar li jaffettwaw is-sistema reninangiotensin-aldosterone u/jew is-supplimenti tal-potassium.
English: OTHER
Maltese: Ansjetà
English: NAME OF THE MEDICINAL PRODUCT Pritor 20 mg tablets telmisartan
Maltese: Informazzjoni għall-utent Pritor 20 mg pilloli Telmisartan
English: In patients whose vascular tone and renal function depend predominantly on the activity of the reninangiotensin-aldosterone system (e.g. patients with severe congestive heart failure or underlying renal disease, including renal artery stenosis), treatment with medicinal products that affect this system such as telmisartan has been associated with acute hypotension, hyperazotaemia, oliguria, or rarely acute renal failure (see section 4.8).
Maltese: F'pazjenti fejn it-ton vaskulari u l-funzjoni renali jiddependu b'mod predominanti mill-attività tassistema renin-angiotensin-aldosterone (eż. pazjenti b'insuffiċjenza konġestiva severa tal-qalb jew li għandhom mard prinċipali renali, li jinkludi stenosi ta' l-arterja renali), il-kura bi prodotti mediċinali oħrajn li jaffettwaw din is-sistema bħal telmisartan kienet assoċjata ma' pressjoni baxxa ħafna akuta, iperażotemija, oligurja, jew b'mod rari ma' insuffiċjenza renali akuta (ara sezzjoni 4.8).
English: Tel: +34-93-495 65 00
Maltese: Bayer Hispania S.L. Tel: +34-93-495 65 00
English: White round tablets of 2.5 mm engraved with the code number '50H' on one side and the company logo on the other side.
Maltese: Pilloli bojod tondi ta' 2.5 mm li fuqhom hemm imnaqqax in-numru tal-kodiċi ‘50H' fuq naħa waħda u l-logo tal-kumpanija fuq in-naħa l-oħra.
English: There is an increased risk of severe hypotension and renal insufficiency when patients with bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney are treated with medicinal products that affect the renin-angiotensin-aldosterone system.
Maltese: Hemm riskju miżjud ta' pressjoni baxxa ħafna severa u insuffiċjenza renali meta pazjenti bi stenosi bilaterali fl-arterja renali jew bi stenosi ta' l-arterja għal kilwa waħda li tkun taħdem, ikunu kkurati bi prodotti mediċinali li jaffettwaw is-sistema renin-angiotensin-aldosterone.
English: Each tablet contains 80 mg telmisartan.
Maltese: Kull pillola fiha 80 mg telmisartan.
English: • manifest atherothrombotic cardiovascular disease (history of coronary heart disease, stroke, or peripheral arterial disease) or
Maltese: • mard kardjovaskulari aterotrombotiku sintomatiku (storja medika ta' mard koronarju tal-qalb,
English: The effect of Pritor may be reduced when you take NSAIDs (non steroidal anti-inflammatory medicines, e.g. aspirin or ibuprofen) or corticosteroids.
Maltese: L-effetti ta' Pritor jistgħu jitnaqqsu meta tieħu NSAIDs (mediċini mhux sterojdi kontra linfjammazzjoni, eż. aspirina jew ibuprofen) jew kortikosterojdi.
English: What Pritor looks like and contents of the pack Pritor 20 mg tablets are white, round and engraved with the code number '50H' on one side and the company logo on the other side.
Maltese: Il-pilloli Pritor 20 mg huma bojod, b'forma tonda u mnaqqxa bin-numru tal-kodiċi ‘50H' fuq naħa waħda u l-logo tal-kumpanija fuq in-naħa l-oħra.
English: The risk may increase in case of treatment combination with other medicinal products that may also provoke hyperkalaemia (salt substitutes containing potassium, potassium-sparing diuretics, ACE inhibitors, angiotensin II receptor antagonists, non steroidal antiinflammatory medicinal products (NSAIDs, including selective COX-2 inhibitors), heparin, immunosuppressives (cyclosporin or tacrolimus), and trimethoprim).
Maltese: Ir-riskju jista' jiżdied f'każ li l-kura tingħata flimkien ma' prodotti mediċinali oħra li jistgħu jikkawżaw ukoll l-iperkalemija (sostituti tal-melħ li fihom ilpotassium, dijuretiċi li ma jneħħux potassium, inibituri ta' ACE, antagonisti tar-riċettur ta' angiotensin II, prodotti mediċinali mhux sterojdi kontra l-infjammazzjoni (NSAIDs, li jinkludu inibituri COX-2 selettivi), eparina, immunosoppressuri (cyclosporin jew tacrolimus), u trimethoprim).
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 kienu t-tnejn numerikament iktar frekwenti fil-grupp ta' aliskiren milli fil-grupp tal-plaċebo, u avvenimenti avversi u avvenimenti avversi serji ta' interess (iperkalemija, pressjoni baxxa u disfunzjoni tal-kliewi) ġew irrappurtati b'mod iktar frekwenti fil-grupp ta' aliskiren milli fil-grupp tal-plaċebo.
English: EU/1/98/089/001 (14 tablets) EU/1/98/089/002 (28 tablets) EU/1/98/089/021 (30 tablets) EU/1/98/089/003 (56 tablets) EU/1/98/089/017 (90 tablets) EU/1/98/089/004 (98 tablets) EU/1/98/089/005 (280 tablets) EU/1/98/089/015 (28 x 1 tablets)
Maltese: Pritor 40 mg pilloli EU/1/98/089/001 (14-il pillola) EU/1/98/089/002 (28 pillola) EU/1/98/089/021 (30 pillola) EU/1/98/089/003 (56 pillola) EU/1/98/089/017 (90 pillola) EU/1/98/089/004
English: Close monitoring of serum potassium in at risk patients is recommended (see section 4.5).
Maltese: Monitoraġġ mill-qrib tal-potassium fis-serum f'pazjenti li qegħdin f'riskju hu rakkomandat (ara sezzjoni 4.5).
English: The occurrence of hyperkalaemia depends on associated risk factors.
Maltese: L-okkorrenza ta' l-iperkalemija tiddependi fuq fatturi marbuta mar-riskju.
English: • Elevated potassium levels in your blood.
Maltese: • Livelli għolja ta' potassium fid-demm tiegħek
English: Pritor belongs to a class of medicines known as angiotensin II receptor antagonists.
Maltese: TWISSIJA SPEĊJALI LI L-PRODOTT MEDIĊINALI GĦANDU JINŻAMM
English: This medicinal product contains sorbitol (E420).
Maltese: Dan il-prodott mediċinali fih is-sorbitol (E420).
English: Urinary tract infections, upper respiratory tract infections (e.g. sore throat, inflamed sinuses, common cold), deficiency in red blood cells (anaemia), high potassium levels, difficulty falling asleep, feeling sad (depression), fainting (syncope), feeling of spinning (vertigo), slow heart rate (bradycardia), low blood pressure (hypotension) in users treated for high blood pressure, dizziness on standing up (orthostatic hypotension), shortness of breath, cough, abdominal pain, diarrhoea, discomfort in the abdomen, bloating, vomiting, itching, increased sweating, drug rash, back pain, muscle cramps, muscle pain (myalgia), kidney impairment including acute kidney failure, pain in the chest, feeling of weakness, and increased level of creatinine in the blood.
Maltese: Infezzjonijiet fl-apparat urinarju, infezzjonijiet fil-parti ta' fuq tal-apparat respiratorju (eż. uġigħ filgriżmejn, sinuses infjammati, riħ komuni), tnaqqis fin-numru ta' ċelluli ħomor tad-demm (anemija), livelli għolja ta' potassium, diffikultà biex torqod, tħossok imdejjaq/imdejqa (dipressjoni), ħass ħażin (sinkope), sensazzjoni li kollox qed idur bik (sturdament), taħbit tal-qalb bil-mod (bradikardija), pressjoni tad-demm baxxa (ipotensjoni) f'persuni kkurati għal pressjoni tad-demm għolja, sturdament meta wieħed iqum bilwieqfa (ipotensjoni ortostatika), qtugħ ta' nifs, sogħla, uġigħ ta' żaqq, dijarea, skonfort fiż-żaqq, nefħa fiż-żaqq, rimettar, ħakk, żieda fl-għaraq, raxx minħabba l-mediċina, uġigħ fiddahar, bugħawwieġ fil-muskoli, uġigħ fil-muskoli (majalġja), indeboliment fil-kliewi li jinkludi insuffiċjenza akuta tal-kliewi, uġigħ fis-sider, sensazzjoni ta' dgħufija, u żieda fil-livell ta' krejatinina fid-demm.
English: Pritor may increase the blood pressure lowering effect of other medicines used to treat high blood pressure or of medicines with blood pressure lowering potential (e.g. baclofen, amifostine).
Maltese: Pritor jista' jżid l-effett ta' tnaqqis tal-pressjoni tad-demm ta' mediċini oħra li jintużaw għall-kura ta' pressjoni tad-demm għolja jew ta' mediċini b'potenzjal li jbaxxu l-pressjoni tad-demm (eż. baclofen, amifostine).
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Pritor 20 mg tablets
Maltese: U KWANTITATTIVA Pritor 20 mg pilloli
English: At the beginning of the preventive therapy with Pritor 80 mg, blood pressure should be frequently monitored.
Maltese: Fil-bidu tat-terapija preventiva b'Pritor 80mg, il-pressjoni tad-demm għandha tiġi mmonitorjata ta' spiss.
English: Dyspnoea, cough Interstitial lung disease
Maltese: Dispnea, sogħla Mard interstizjali tal-pulmun
English: For reduction of cardiovascular events, the usual dose of Pritor is one 80 mg tablet once a day.
Maltese: Għal tnaqqis ta' avvenimenti kardjovaskulari, id-doża tas-soltu ta' Pritor hi ta' pillola waħda ta' 80 mg darba kuljum.
English: There is an apparent trend to a dose relationship to a time to recovery of baseline systolic blood pressure (SBP).
Maltese: Hemm tendenza apparenti għal relazzjoni bejn doża u l-ħin ta' l-irkupru tal-linja bażi tal-pressjoni sistolika tad-demm (SBP).
English: The most prominent manifestations of telmisartan overdose were hypotension and tachycardia; bradycardia, dizziness, increase in serum creatinine, and acute renal failure have also been reported.
Maltese: L-iktar manifestazzjonijiet prominenti ta' doża eċċessiva ta' telmisartan kienu pressjoni tad-demm baxxa ħafna u takikardja; il-bradikardija, sturdament, żieda fil-livell tal-krejatinina fis-serum u insuffiċjenza renali akuta kienu osservati wkoll.
English: What Pritor looks like and contents of the pack Pritor 80 mg tablets are white, oblong-shaped and engraved with the code '52H' on one.
Maltese: Il-pilloli Pritor 80 mg huma bojod, b'forma oblunga u mnaqqxa bin-numru tal-kodiċi ‘52H' fuq naħa waħda.
English: The elimination half-life is not changed in patients with renal impairment.
Maltese: Il-half-life ta' leliminazzjoni ma tinbidilx f'pazjenti b'indeboliment renali.
English: In one study the co-administration of telmisartan and ramipril led to an increase of up to 2.5 fold in the AUC0-24 and Cmax of ramipril and ramiprilat.
Maltese: Fi studju wieħed, l-għoti flimkien ta' telmisartan u ramipril wassal għal żieda ta' sa 2.5 darbiet flAUC0-24 u s-Cmax ta' ramipril u ramiprilat.
English: Differences in plasma concentrations were observed, with Cmax and AUC being approximately 3- and 2-fold higher, respectively, in females compared to males.
Maltese: Differenzi fil-konċentrazzjonijiet fil-plażma kienu osservati, bis-Cmax u l-AUC li kienu madwar 3 darbiet u darbtejn ogħla, rispettivament, fin-nisa meta mqabbla mal-irġiel.
English: Alternatively, telmisartan may be used in combination with thiazide-type diuretics such as hydrochlorothiazide, which has been shown to have an additive blood pressure lowering effect with telmisartan.
Maltese: Inkella, telmisartan jista' jintuża flimkien ma' tipi ta' dijuretiċi tat-tip thiazide, bħal hydrochlorothiazide, li ntwera li għandu effett addizzjonali li jnaqqas il-pressjoni tad-demm b'telmisartan.
English: There is no evidence of clinically relevant accumulation of telmisartan taken at the recommended dose.
Maltese: M'hemmx evidenza ta' akkumulazzjoni ta' telmisartan li hi klinikament rilevanti meta dan jittieħed fid-doża rakkomandata.
English: Байер България ЕООД Тел.
Maltese: Magyarország Bayer Hungária Kft. Tel.
English: Sepsis* (often called "blood poisoning", is a severe infection with whole-body inflammatory response which can lead to death), increase in certain white blood cells (eosinophilia),low platelet count (thrombocytopenia), severe allergic reaction (anaphylactic reaction), allergic reaction (e.g. rash, itching, difficulty breathing, wheezing, swelling of the face or low blood pressure), low blood sugar levels (in diabetic patients), feeling anxious, somnolence, impaired vision, fast heart beat (tachycardia), dry mouth, upset stomach, taste disturbance (dysgeusia), abnormal liver function (Japanese patients are more likely to experience this side effect) , rapid swelling of the skin and mucosa which can also lead to death (angioedema also with fatal outcome), eczema (a skin disorder), redness of skin, hives (urticaria), severe drug rash, , joint pain (arthralgia), pain in extremity, tendon pain, flu-like-illness, decreased haemoglobin (a blood protein), increased levels of uric acid, increased hepatic enzymes or creatine phosphokinase in the blood.
Maltese: Sepsis* (ta' spiss imsejħa "avvelenament tad-demm", hi infezzjoni severa b'rispons infjammatorju mal-ġisem kollu li tista' twassal għal mewt), żieda f'ċerti ċelluli bojod tad-demm (eosinofilija), għadd baxx ta' plejtlits (tromboċitopenja), reazzjoni allerġika severa (reazzjoni anafilattika), reazzjoni allerġika (eż. raxx, ħakk, diffikultà biex tieħu n-nifs, tħarħir, nefħa tal-wiċċ jew pressjoni tad-demm baxxa), livelli baxxi ta' zokkor fid-demm (f'pazjenti dijabetiċi, tħossok ansjuż/a, ngħas, indeboliment fil-vista, rata mgħaġġla ta' taħbit tal-qalb (takikardija), ħalq xott, stonku mqalleb, disturb fit-togħma (tibdil fis-sens tat-togħma), funzjoni anormali tal-fwied (hemm aktar ċans li pazjenti Ġappuniżi jkollhom dan l-effett sekondarju), nefħa mgħaġġla tal-ġilda u tal-mukuża li tista wkoll twassal għal mewt (anġjoedema wkoll b'riżultat fatali), ekżema (disturb tal-ġilda), ħmura tal-ġilda, urtikarja (ħorriqija), raxx sever minħabba l-mediċina, uġigħ fil-gogi (artralġja), uġigħ fl-estremitajiet, uġigħ fit tendini, mard li jixbah l-influwenza, tnaqqis fl-emoglobina (proteina fid-demm), żieda fil-livelli taluric acid, żieda fl-enzimi epatiċi jew ta' creatine phosphokinase fid-demm u tnaqqis fl-emoglobina (proteina fid-demm).
English: Hepatic function abnormal / liver disorder
Maltese: Funzjoni anormali tal-fwied/disturb fil-fwied
English: PC: {number} [product code]
Maltese: {numru} [kowd tal-prodott]
English: Rare side effects (may affect up to 1 in 1,000 people):
Maltese: Effetti sekondarji rari (jistgħu jaffettwaw sa persuna 1 minn kull 1,000):
English: Pritor may also be used in combination with diuretics ('water tablets') such as hydrochlorothiazide which has been shown to have an additive blood pressure lowering effect with Pritor.
Maltese: Pritor jista' jintuża flimkien ma' dijuretiċi (‘pilloli tal-awrina') bħal hydrochlorothiazide, li ntwera li għandu effett addizzjonali ta' tnaqqis tal-pressjoni tad-demm bi Pritor.
English: The full EPAR for Insuman 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: Insuman human insulin
Maltese: Insuman insulina umana
English: The pump must not be implanted in people who reside permanently at elevations above at elevations above 2,439 metres (8000 feet).
Maltese: Il-pompa m'għandhiex tiġi impjantata f'persuni li jgħixu b'mod permanenti f'għoli ta' aktar minn 2,439 metru (8000 pied).
English: This is a summary of the European public assessment report (EPAR) for Insuman.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Insuman.
English: The active substance in Insuman, human insulin, is produced by a method known as ‘recombinant DNA technology': it is made by bacteria into which a gene (DNA) has been introduced that makes the bacteria able to produce insulin.
Maltese: Is-sustanza attiva f'Insuman, l-insulina umana, tiġi prodotta b'metodu magħruf bħala ‘teknoloġija rikombinanti tad-DNA': dan isir minn batterji li fihom tkun ġiet introdotta ġene (DNA) li tagħmel ilbatterji kapaċi jipproduċu l-insulina.
English: • Insuman Rapid, Insuman Infusat and Insuman Implantable, which are fast-acting insulin solutions containing soluble insulin;
Maltese: • Insuman Rapid, Insuman Infusat u Insuman Implantable, li huma soluzzjonijiet tal-insulina b'azzjoni immedjata li fihom insulina li tinħall;
English: • Insuman Basal, an intermediate-acting insulin suspension containing isophane insulin;
Maltese: • Insuman Basal, sospensjni tal-insulina li taħdem b'mod intermedju li fiha l-insulina isofana;