FrancophonIA/ELRC3.0 huggingface dataset:
English: On 11 December 2009, Bayer Schering Pharma AG officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Recothrom, for use in stopping bleeding during surgery where standard surgical techniques are insufficient.
Maltese: Fil-11 ta' Diċembru 2009, Bayer Schering Pharma AG innotifikat uffiċjalment lill-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) li hija tixtieq tirtira l-applikazzjoni tagħha għallawtorizzazzjoni għat-tqegħid fis-suq għal Recothrom, li jintuża sabiex iwaqqaf il-fsada waqt l-interventi kirurġiċi meta tekniki kirurġiċi standard ma jkunux biżżejjed.
English: Recothrom is a powder and solvent for solution to be applied to a surgical wound.
Maltese: Recothrom huwa trab u solvent għal soluzzjoni li tiġi applikata fuq ferita kirurġika.
English: Thrombin converts another protein called fibrinogen into smaller units called fibrin.
Maltese: It-trombina tibdel proteina oħra msejħa fibrinoġen f'unitajiet iżgħar li jissejħu fibrin.
English: This means that the CHMP had evaluated the documentation provided by the company and formulated a list of questions.
Maltese: Dan ifisser li s-CHMP kien evalwa d-dokumentazzjoni li pprovdiet il-kumpanija u fformula lista ta' mistoqsijiet.
English: The CHMP was concerned that the company provided evidence from specialised surgeries, whereas Recothrom was intended for more general use.
Maltese: Is-CHMP kien imħasseb li l-kumpanija pprovdiet provi minn kirurġiji speċjalizzati, filwaqt li Recothrom kien maħsub għal użu aktar ġenerali.
English: Recothrom was expected to be applied to the surgical wounds either using a gelatin sponge soaked with the solution, or by spraying the solution directly into the surgical wound.
Maltese: Recothrom kien mistenni li jiġi applikat fuq feriti kirurġiċi jew permezz ta' sponza tal-ġelatina mxarrba bis-soluzzjoni, jew inkella billi s-soluzzjoni tiġi sprejjata direttament fil-ferita kirurġika.
English: According to EU requirements, Recothrom should have been compared with a standard treatment that did not contain thrombin.
Maltese: Skont ir-rekwiżiti tal-UE, Recothrom kellu jitqabbel ma' kura standard li ma fihiex trombina.
English: Based on the review of the data and the company's response to the CHMP list of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Recothrom could not have been approved for use in stopping bleeding during surgery where standard surgical techniques are insufficient.
Maltese: Skont l-analiżi tad-dejta u t-tweġiba tal-kumpanija għal-lista ta' mistoqsijiet tas-CHMP, fiż-żmien talirtirar, is-CHMP kellu xi tħassib u kien tal-opinjoni provviżorja li Recothrom ma setax ikun approvat għall-użu fil-waqfien ta' fsada waqt l-interventi kirurġiċi meta tekniki kirurġiċi standard ma jkunux biżżejjed.
English: Recothrom was expected to be used to stop bleeding during an operation when standard surgical techniques are insufficient.
Maltese: Recothrom kien mistenni li jintuża sabiex iwaqqaf il-fsada waqt operazzjoni meta tekniki kirurġiċi standard ma jkunux biżżejjed.
English: The company presented results of one main study involving 463 patients undergoing different types of
Maltese: Il-kumpanija ppreżentat riżultati ta' studju ewlieni wieħed li kien jinvolvi 463 pazjent li kienu qegħdin isirulhom tipi differenti ta' kirurġija.
English: How was Recothrom expected to work?
Maltese: Għalxiex kien mistenni li jintuża Recothrom?
English: What was Recothrom expected to be used for?
Maltese: Kif kien mistenni li jaħdem Recothrom?
English: The effects of Recothrom were first tested in experimental models before being studied in humans.
Maltese: L-effetti ta' Recothrom għall-ewwel ġew ittestjati f'mudelli sperimentali qabel ma ġew studjati fuq ilbniedem.
English: The study compared Recothrom with another medicine containing thrombin and the main measure of effectiveness was the number of patients whose bleeding stopped within 10 minutes.
Maltese: trombina u l-miżura ewlenija tal-effikaċja kienet l-għadd ta' pazjenti li l-fsada tagħhom waqfet fi żmien 10 minuti.
English: 28027 MADRID, Spain
Maltese: 28027 MADRID, Spanja
English: For reconstitution see section 6.6.
Maltese: Għal rikostituzzjoni ara sezzjoni 6.6.
English: Name and address} <{tel}> <{fax}> <{e-mail}>
Maltese: Isem u indirizz} <{tel}> <{faks}> <{e-mail}>
English: Lindenplatz 1 85540, Haar, Germany
Maltese: Lindenplatz 1 85540, Haar, IlĠermanja
English: 00-867 Warsaw, Poland
Maltese: 00-867 Warsaw, Il-Polonja
English: Austria, Belgium/Luxembourg, Bulgaria, Cyprus, Germany, Denmark, Estonia, Greece, Finland, France, Hungary, Ireland, Italy, Lithuania, Latvia, Malta, Netherlands, Poland, Portugal, Romania, Slovenia, Spain, Sweden, United Kingdom, Iceland, Norway
Maltese: L-Awstrija, Il-Belġju/Il-Lussemburgu, Il-Bulgarija, Ċipru, Il-Ġermanja, Id-Danimarka, L-Estonja, Il-Greċja, Il-Finlandja, Franza, L-Ungerija, L-Irlanda, L-Italja, Il-Litwanja, Il-Latvija, Malta, L-Olanda, Il-Polonja, Il-Portugall, Ir-Rumanija, Is-Slovenja, Spanja, L-Iżvezja, Ir-renju Unit, L-Iżlanda, In-Norveġja
English: 1407 Sofia, Bulgaria
Maltese: 1407 Sofia, Il-Bulgarja
English: Sector 1, Bucureşti, România
Maltese: Sector 1, Bucureşti, Ir-Rumanija
English: Angioedema.
Maltese: Anġjoedema.
English: Tatoiou Street, Nea Erythraia 14671, Greece
Maltese: Tatoiou Street, Nea Erythraia 14671, Il-Greċja
English: Sigma-Tau Industrie Farmaceutiche Riunite S.p.A.- Viale Shakespeare 47, 00144 Rome, Italy
Maltese: Sigma-Tau Industrie Farmaceutiche Riunite S.p.A.- Viale Shakespeare 47, 00144
English: VARIPHARM ARZNEIMITTEL GmbH
Maltese: ARZNEIMITTEL GmbH
English: H-1123 Budapest, Hungary
Maltese: H1123 Budapest, L-Ungerija
English: PHARMACEUTICAL FORM AND CONTENTS 200 ml oral suspension
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT 200 ml suspensjoni orali
English: MSD Chibropharm GmbH Postfach 1202 D-85530 Haar, Germany
Maltese: MSD Chibropharm GmbH Postfach 1202 D-85530
English: Merck Sharp & Dohme, inovativna zdravila d.o.o., Šmartinska cesta 140, 1000 Ljubljana, Slovenia
Maltese: Merck Sharp & Dohme, inovativna zdravila d.o.o., Šmartinska cesta 140, 1000 Ljubljana, Is-Slovenja
English: UAB Merck Sharp & Dohme, Geležinio Vilko 18A, LT- 01112 Vilnius, Lithuania
Maltese: UAB Merck Sharp & Dohme, Geležinio Vilko 18A, LT- 01112 Vilnius, Il-Litwanja
English: Hertfordshire EN11 9BU United Kingdom
Maltese: Hertfordshire EN11 9BU Ir-Renju Unit
English: The systemic bioavailability of losartan tablets is approximately 33 %.
Maltese: Il-bijodisponibilità sistemika tal-pilloli losartan hi ta' madwar 33%.
English: Sorbitol/Fructose intolerance
Maltese: Sorbitol/Intolleranza għal fruttosju
English: Merck Sharp & Dohme GmbH Donau-City-Straße 6, 1220 Wien, Austria
Maltese: Merck Sharp & Dohme GmbH Donau-City-Straße 6, 1220 Wien, LAwstrija
English: PHARMACEUTICAL FORM AND CONTENTS 473 ml solvent
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT 473 ml solvent
English: MSD Polska Sp. z o.o.
Maltese: MSD Polska Sp. z o.o. Chłodna 51
English: 75114 Paris Cedex 08, France
Maltese: Paris Cedex 08, Franza
English: • inflammation of blood vessels (vasculitis including Henoch-Schönlein purpura),
Maltese: • infjammazzjoni tal-vażi tad-demm (vaskulite li tinkludi purpura Henoch-Schonlein),
English: Cardiac disorders: rare: syncope, atrial fibrillation, cerebrovascular accident
Maltese: Disturbi tal-qalb: rari: sinkope, fibrillazzjoni atrijali, aċċident ċerebrovaskulari
English: The solvent contains sorbitol.
Maltese: Is-solvent fih sorbitol.
English: Electrolyte imbalances
Maltese: Żbilanċi elettrolitiċi
English: Administration of the oral suspension
Maltese: DOŻA TA' SUSPENSJONI ORALI
English: • a 473 ml white, high-density polyethylene (HDPE) bottle of solvent,
Maltese: • flixkun ta' 473 ml solvent magħmul f'high-density polyethylene (HDPE),
English: 11415 Tallinn, Estonia
Maltese: Tallinn, L-Estonja
English: The mean length of follow-up was 4.8 years.
Maltese: Iż-żmien medju ta' follow-up kien ta' 4.8 snin.
English: Hypotension and Electrolyte/Fluid Imbalance
Maltese: Pressjoni Baxxa u Żbilanċ tal-Elettrolitiċi/Fluwidu
English: PHARMACOLOGICAL PROPERTIES Pharmacotherapeutic group: Angiotensin II antagonists, plain, ATC code: C09CA01 5.1 Pharmacodynamic properties
Maltese: Antagonisti tar-riċettatur ta' Angiotensin II, komuni, Kodiċi ATC: C09CA01
English: Take special care with COZAAR:
Maltese: Tieħux Cozaar:
English: Powder microcrystalline cellulose (E460) lactose monohydrate pregelatinized maize starch magnesium stearate (E572) hydroxypropyl cellulose (E463) hypromellose (E464) titanium dioxide (E171)
Maltese: Trab microcrystalline cellulose (E460) lactose monohydrate pregelatinized maize starch magnesium stearate (E572) hydroxypropyl cellulose (E463) hypromellose (E464) titanium dioxide (E171)
English: Microcrystalline cellulose (E460), Lactose monohydrate, Pregelatinized maize starch, Magnesium stearate (E572), Hydroxypropyl cellulose (E463), Hypromellose (E464), and titanium dioxide (E171)
Maltese: Microcrystalline cellulose (E460), Lactose monohydrate, Pregelatinized maize starch, Magnesium stearate (E572), Hydroxypropyl cellulose (E463), Hypromellose (E464), u titanium dioxide (E171).
English: • Lactation (see section 4.6).
Maltese: • Treddigħ (ara sezzjoni 4.6).
English: Hyperkalaemia (serum potassium >5.5 mmol/l) occurred in 1.5 % of patients in hypertension clinical trials.
Maltese: Iperkalemja (>5.5 mmol/l potassju fis-serum) seħħet f'1.5% tal-pazjenti li kellhom pressjoni għolja fil-provi kliniċi.
English: Microcrystalline cellulose (E460), carboxymethylcellulose sodium, citric acid anhydrous, purified water, xantham gum (E415), methylhydroxybenzoate (E218), sodium phosphate monobasic monohydrate, potassium sorbate, carrageenan calcium sulfate trisodium phosphate, flavor berry citrus sweet, glycerin, propylhydroxybenzoate (E216), sodium citrate anhydrous, saccharin sodium, sorbitol (E420)antifoam Af emulsion (contains water, polydimethylsiloxane, C-14-18, mono- and diglycerides, polyethylene glucol stearate, and polyethylene glycol).
Maltese: Microcrystilline cellulose (E460), carboxymethylcellulose sodium, citric acid anhydrous, ilma purifikat, xantham gum (E415), methylhydroxybenzoate (E218), sodium phosphate monobasic monohydrate, potassium sorbate, carrageenan calcium sulfate trisodium phosphate, benna ta' ħelu taċċirasa u taċ-ċitru, glycerin, propylhydroxybenzoate (E216), sodium citrate anhydrous, saccharin sodium, sorbitol (E420) Emulsjoni ta' sorbitol (E420) antifowm (li fih ilma, polydimethylsiloxane, C14-18, mono- u di-glycerides, polyethylene glucol stearate u polyethylene glycol).
English: Store the prepared suspension in a refrigerator at 2-8°C.
Maltese: Aħżen is-suspensjoni ppreparata fi friġġ f'temperatura ta' bejn 2-8°C.
English: Treatment with losartan reduced the risk of stroke by 25 % relative to atenolol (p=0.001 95 % confidence interval 0.63-0.89).
Maltese: It-trattament b'losartan naqqas ir-riskju ta' puplesija b'25% meta mqabbel ma' atenolol (p=0.001 95% intervall ta' kunfidenza 0.63-0.89).
English: In controlled clinical trials, clinically important changes in standard laboratory parameters were rarely associated with administration of Losartan tablets.
Maltese: Fi provi kliniċi b'kontrolli, bidliet klinikament importanti f'parametri tal-laboratorju standard rarement kienu assoċjati mal-għoti ta' pilloli Losartan.
English: • localised swelling (oedema).
Maltese: • nefħa lokalizzata (edema)..
English: Following an oral dose/intravenous administration of 14C-labeled losartan in man, about 35 % / 43 % of radioactivity is recovered in the urine and 58 %/ 50 % in the faeces.
Maltese: Wara doża meħuda mill-ħalq/ġol-vina ta' losartan ittikkettat b'14C fil-bniedem, madwar 35% / 43% ta' radjoattività ġiet irkuprata fl-urina u 58%/ 50% fl-ippurgar.
English: Kit: Do not store above 25°C.
Maltese: Kitt: Taħżins f'temperatura 'l fuq minn 25°C.
English: • Reduction in the risk of stroke in adult hypertensive patients with left-ventricular hypertrophy documented by ECG (see section 5.1 LIFE study, Race).
Maltese: • Tnaqqis fir-riskju ta' puplesija f'pazjenti li għandhom pressjoni għolja b'ipertrifija fil-ventrikula tax-xellug iddokumentata b'ECG (ara sezzjoni 5.1: Studju LIFE, Razza).
English: The frequency of adverse events listed below is defined using the following convention: very common (≥ 1/10); common (≥ 1/100, to < 1/10); uncommon (≥ 1/1,000, to < 1/100); rare (≥ /10,000, to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).
Maltese: Il-frekwenza ta' każijiet avversi elenkati hawn isfel hija mfissra bil-konvenzjoni li ġejja: komuni ħafna (≥ 1/10); komuni (≥ 1/100 sa < 1/10); mhux komuni (≥ 1/1,000 sa < 1/100); rari (≥ 1/10,000 sa < 1/1,000); rari ħafna (< 1/10,000), mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: Blood pressure reduction at the end of the dosing interval was 70 - 80 % of the effect seen 5-6 hours postdose.
Maltese: It-tnaqqis fil-pressjoni tad-demm fl-aħħar tal-intervall dożat kien ta' 70 - 80 % tal-effett li deher 5 - 6 sigħat wara d-doża.
English: In a clinical trial it was found that fluconazole (inhibitor of CYP2C9) decreases the exposure to the active metabolite by approximately 50 %.
Maltese: Fi prova klinika nstab li fluconazole (impeditur ta' CYP2C9) inaqqas l-espożizzjoni għal metabolit attiv b'madwar 50%.
English: Always shake <COZAAR>oral suspension well before use!
Maltese: Dejjem ħallat is-suspensjoni orali COZAAR qabel ma tuża!
English: Solvent microcrystalline cellulose carboxymethylcellulose sodium citric acid anhydrous purified water xantham gum (E415) methylhydroxybenzoate (E218) sodium phosphate monobasic monohydrate potassium sorbate (E202) carrageenan calcium sulfate, trisodium phosphate flavor berry citrus sweet glycerin propylhydroxybenzoate (E216) sodium citrate anhydrous saccharin sodium sorbitol (E420)antifoam AF emulsion (contains water, polydimethylsiloxane, C-14-18, mono- and diglycerides, polyethylene glucol stearate, and polyethylene glycol.)
Maltese: Solvent microcrystalline cellulose carboxymethylcellulose sodium citric acid anhydrous ilma purifikat xantham gum (E415) methylhydroxybenzoate (E218) sodium phosphate monobasic monohydrate potassium sorbate (E202) carrageenan calcium sulfate, trisodium phosphate benna ta' ħelu taċ-ċirasa u taċ-ċitru glycerin propylhydroxybenzoate (E216) sodium citrate anhydrous saccharin sodium
English: • One 473 ml bottle of solvent
Maltese: • Flixkun ta' 473 ml solventi
English: Important information about some of the ingredients of COZAAR COZAAR contains lactose monohydrate and sorbitol.
Maltese: Informazzjoni importanti dwar xi wħud mis-sustanzi ta' COZAAR COZAAR fih lactose monohydrate u sorbitol.
English: Galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucosegalactose malabsorption should not take this medicine.
Maltese: Intolleranza għal gallatosju, defiċjenza għal Lapp lactase, problemi fl-assorbiment ta' glukosju-gallattosju:
English: • if your liver function is impaired (see sections 2 "Do not take Losartan" and 3 ‘Dosage in special patient groups'),
Maltese: • jekk il-funzjoni tal-fwied tiegħek hi indebolita (ara sezzjonijiet 2 “Tieħux Cozaar”, u 3, “Id-doża di gruppi speċjali”),
English: • 2nd and 3rd trimester of pregnancy (see section 4.6).
Maltese: • 2 u 3 trimestru ta' tqala (ara sezzjonijiet 4.4 u 4.6).
English: 5.38 mmHg high dose).
Maltese: 12.21 mmHg).
English: Belgium Therabel Pharma S.A. - Rue Egide Van Ophem 108 - B-1180 Brussels, Belgium
Maltese: Therabel Pharma S.A. - Rue Egide Van Ophem 108 - B-1180 Brussels, IlBelġju
English: No difference in exposure was found with concomitant treatment with fluvastatin (weak inhibitor of CYP2C9).
Maltese: Ma nstabet l-ebda differenza fl-espożizzjoni bi trattament flimkien ma' fluvastatin (impeditur ħafif ta' CYP2C9).
English: Renal clearance of losartan and its active metabolite is about 74 ml/min and 26 ml/min, respectively.
Maltese: It-tneħħija mill-kliewi ta' losartan u l-metabolit attiv tiegħu hi ta' madwar 74 ml/min u 26 ml/min, rispettivament.
English: Treatment with losartan resulted in a 13.0 % risk reduction (p=0.021, 95 % confidence interval 0.77-0.98) compared with atenolol for patients reaching the primary composite endpoint.
Maltese: It-trattament b' losartan irriżulta fi tnaqqis ta' 13.0% fir-riskju (p=0.021, 95 % intervall ta' kunfidenza 0.77-0.98) imqabbel ma' atenolol għal pazjenti li jilħqu l-ewwel punt ta' riferiment kompost prinċipali.
English: United Kingdom Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Herts EN11 9BU, United Kingdom
Maltese: United Kingdom Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Herts EN11 9BU, Ir-Renju Unit
English: Blood pressure may also be lowered by one of the following drugs/ class of drugs: tricyclic antidepressants, antipsychotics, baclofene, amifostine.
Maltese: Il-pressjoni tad-demm tissta' wkoll tiġi mnaqqsa b'xi waħda mill-mediċini/kategorija ta' mediċini li ġejjin: mediċini ta' kontra d-dipressjoni triċikliċi, mediċini kontra l-psikosi, baclofene, amifostine,
English: • In a controlled clinical trial in 177 hypertensive pediatric patients 6 to 16 years of age
Maltese: • Fi prova klinika bil-kontrolli f'177 pazjent pedjatriku bil-pressjoni għolja ta' bejn 6 sa 16-il sena
English: Both losartan and its active metabolite are ≥99 % bound to plasma proteins, primarily albumin.
Maltese: Kemm losartan u l-metabolit attiv tiegħu huma ≥99% marbutin ma' proteini fil-plażma, prinċipalment l-albumina.
English: • Treatment of essential hypertension in adults and in children and adolescents 6 - 16 years of age.
Maltese: • Trattament għal pressjoni essenzjali għolja f'adulti u fi tfal u adoloxxenti ta' bejn 6 - 16 sena
English: uncommon: urticaria, pruritus, rash
Maltese: Mhux komuni: dijarea, tqalligħ, remettar
English: Very rare:
Maltese: Rari Ħafna:
English: In a clinical study conducted in type 2 diabetic patients with nephropathy, 9.9 % of patients treated with Losartan tablets developed hyperkalaemia >5.5 mEq/l and 3.4 % of patients treated with placebo Post-marketing experience
Maltese: Fi studju kliniku li sar fuq pazjenti li kellhom dijabete ta' tip 2 b'nefropatija, iperkalemija >5.5 mEq/l żviluppat f'9.9% ta' pazjenti ttrattati bil-pilloli Losartan u fi 3.4% ta' pazjenti trattati bil-plaċebo.
English: One ml of suspension contains 2.5 mg of losartan potassium.
Maltese: 1 ml ta' suspensjoni fih 2.5 mg ta' losartan potassium.
English: • One 10 ml oral dosing syringe
Maltese: • Siringa waħda ta' 10 ml għal doża orali
English: affects 1 to 10 users I 10000
Maltese: jaffettwa minn utent 1 sa 10 f'kull 10,000
English: An increased mortality was observed in ELITE II in the small subgroup (22 % of all HF patients) taking beta-blockers at baseline.
Maltese: II fis-sottogrupp (22% tal-pazjenti HF) li kien qed jieħu beta-blockers bħala punt ta' riferiment.
English: • In a controlled clinical trial in approximately 3900 patients 20 years of age and older with chronic heart failure
Maltese: • Fi prova klinika bil-kontrolli fuq madwar 3900 pazjent ta' 20 sena jew aktar u b'falliment kroniku tal-qalb
English: • a 10 ml oral dosing polypropylene syringe packed individually with a low density polyethylene push-in bottle neck adapter (PIBA) in a poly bag.
Maltese: • siringa tal-polyproptlene ta' 10 ml li tintuża biex tiddoża b'mod orali ippakkjata individwalment b'adapter li tidħol fil-flixkun tal-polyethylene ta' densità baxxa (push-in bottle neck adapterPIBA)) f'poly bag.
English: • non-steroidal anti-inflammatory drugs such as indomethacin, including cox-2-inhibitors (medicines that reduce inflammation, and can be used to help relieve pain), as they may reduce the blood lowering effect of losartan.
Maltese: • mediċini mhux sterojdi u li jaġixxu kontra l-infjammazzjoni bħal indomethacin, li jinkludu impedituri ta' cox-2 (mediċini li jnaqqsu l-infjammazzjoni, u li jistgħu jintużaw biex ittaffu l-uġigħ) peress li jistgħu inaqqsu l-effett fuq id-demm ta' losartan.
English: Plasma clearance of losartan and its active metabolite is about 600 ml/min and 50 ml/min, respectively.
Maltese: It-tneħħija ta' losartan mill-plażma u tal-metabolit attiv tiegħu hija ta' madwar 600 ml/min u 50 ml/min, rispettivament.
English: WHAT COZAAR IS AND WHAT IT IS USED FOR Losartan (COZAAR) belongs to a group of medicines known as angiotensin-II receptor antagonists.
Maltese: Losartan (COZAAR) jappartjeni għal grupp ta' mediċini msejħa antagonisti tar-riċettatur ta' angiotensin-II.
English: For the following individual and combined components of the primary endpoint, the results showed a significant risk reduction in the group treated with Losartan: 25.3 % risk reduction for doubling of the serum creatinine (p = 0.006); 28.6 % risk reduction for end-stage renal failure (p = 0.002); 19.9 % risk reduction for end-stage renal failure or death (p = 0.009); 21.0 % risk reduction for doubling of serum creatinine or end-stage renal failure (p = 0.01).
Maltese: 002); tnaqqis ta' riskju ta' 19.9 % għal insuffiċjenza renali tal-aħħar stadju jew mewt (p = 0.009); tnaqqis ta' riskju ta' 21.0 % għall-irdoppjar ta' kreatinina tas-serum jew insuffiċjenza renali tal-aħħar stadju (p = 0.01).
English: [See Annex I - To be completed nationally] {Name and address} <{tel}> <{fax}> <{e-mail}>
Maltese: [Ara Anness I - Għandu jitlesta fil-pajjiż stess] {Isem u indirizz} <{tel}> <{faks}> <{e-mail}>
English: Cardiac disorder: Uncommon: palpitations, angina pectoris
Maltese: Disturbi fil-qalb: Mhux komuni: palpitazzjonijiet, anġina pectoris:
English: • if you suffer from primary hyperaldosteronism (a syndrome associated with increased secretion of the hormone aldosterone by the adrenal gland, caused by an abnormality within the gland).
Maltese: • jekk tbati minn iperaldosteroniżmu primarja (sindromu assoċjat ma' żieda fil-produzzjoni tal-ormon aldosterone mill-glandola adrenali, ikkawżata minn abnormalità ġewwa l-glandola).
English: Angiotensin II also stimulates smooth muscle cell proliferation.
Maltese: Angiotensin II jissensitizza wkoll il-proliferazzjoni taċ-ċelluli lixxi tal-muskoli
English: • In a controlled clinical trial in 1513 type 2 diabetic patients 31 years of age and older with proteinuria
Maltese: • Fi prova klinika bil-kontrolli fuq 1513-il pazjent b'dijabete ta' tip 2 ta' 31 sena u aktar bi protejnurja
English: Belgium Merck Sharp & Dohme BV -Chaussée de Waterloo 1135 - B-1180 Brussels, Belgium
Maltese: Merck Sharp & Dohme BV - Chaussée de Waterloo 1135 - B-1180 Brussels, Belgium
English: Hypertensive patients with left-ventricular hypertrophy In a controlled clinical trial in 9193 hypertensive patients 55 to 80 years of age with left-ventricular hypertrophy the following adverse events were reported:
Maltese: Pazjenti bil-pressjoni għolja b'ipertrofija fil-ventrikola tax-xellug Fi prova klinika b'kontrolli fuq 9193 pazjent ta' bejn l-etajiet ta' 55 sa 80 sena bi pressjoni għolja u b'ipertrofija fil-ventrikola tax-xellug, l-effetti avversi li ġejjin kienu rapportati:
English: Immune system disorders: rare: hypersensitivity: anaphylactic reactions, angiooedema including swelling of the larynx and glottis causing airway obstruction and/or swelling of the face, lips, pharynx, and/or tongue; in some of these patients angiooedema had been reported in the past in connection with the administration of other medicines, including ACE inhibitors; vasculitis, including Henoch-Schönlein purpura.
Maltese: Disturbi fis-sistema immuni: rari: sensittività eċċessiva: reazzjonijiet anafilattiċi, anġjodema li tinkludi tinfiħ tal-larinġi u l-glottide li tikkawża impediment fil-passaġġ tal-arja u/jew nefħa fil-wiċċ, ix-xofftejn, il-farinġi u/jew l-ilsien. f'xi wħud minn dawn il-pazjenti anġjodema kienet irrapportata fil-passat u marbuta mal-għoti ta' mediċini oħra li jinkludu impedituri ACE; vaskulite, li tinkludi purpura ta' Henoch-Schoenlein.
English: STATEMENT OF ACTIVE SUBSTANCE(S) One ml suspension contains 2.5 mg of losartan potassium.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kull ml ta' suspensjoni fih 2.5 mg ta'losartan potassium.