FrancophonIA/ELRC3.0 huggingface dataset:
English: What SOMAC Control contains - The active substance is pantoprazole.
Maltese: X'fih SOMAC Control - Is-sustanza attiva hi pantoprazole.
English: SOMAC Control 20 mg gastro-resistant tablets Pantoprazole
Maltese: SOMAC Control 20 mg pilloli gastro-reżistenti Pantoprazole
English: Liver enzymes increased (transaminases , γ-GT)
Maltese: Żieda flenzimi talfwied (transaminas es, γ-GT)
English: Fundic gland polyps (benign)
Maltese: Polipi talglandola fundika (beninni)
English: However, you may take SOMAC Control with antacids (e.g. magaldrate, alginic acid, sodium bicarbonate, aluminium hydroxide, magnesium carbonate, or combinations thereof), if needed.
Maltese: Madankollu, tista' tieħu SOMAC Control ma' antaċidi (eż. magaldrate, alginic acid, sodium bicarbonate, aluminium hydroxide, magnesium carbonate, jew kumbinazzjonijiet tagħhom), jekk ikun meħtieġ.
English: SOMAC Control 20 mg gastro-resistant tablets
Maltese: SOMAC Control 20 mg pilloli gastro-reżistenti
English: Sleep disorders Depression (and all aggravations)
Maltese: Depressjoni (u l-aggravamenti kollha)
English: Other medicines and SOMAC Control
Maltese: Mediċini oħra u SOMAC Control
English: SOMAC Control may reduce the absorption of active substances whose bioavailability is dependent on the gastric pH (e.g. ketoconazole).
Maltese: SOMAC Control jista' jnaqqas l-assorbiment ta' sustanzi attivi li l-bijodisponibiltà tagħhom tiddependi fuq il-pH gastrika (eż. ketoconazole).
English: To avoid this interference, SOMAC Control treatment should be stopped for at least 5 days before CgA measurements (see section 5.1).
Maltese: Biex din l-interferenza tiġi evitata, il-kura bi SOMAC Control għandha titwaqqaf għal mill-inqas 5 ijiem qabel il-kejl ta' CgA (ara sezzjoni 5.1).
English: SOMAC Control may stop certain other medicines from working properly.
Maltese: SOMAC Control jista' jwaqqaf ċertu mediċini oħra milli jaħdmu sew.
English: Talk to your doctor before taking SOMAC Control - if you have been treated for heartburn or indigestion continuously for 4 or more weeks - if you are over 55 years old and taking non-prescription indigestion treatment on a daily basis - if you are over 55 years old with any new or recently changed reflux symptoms - if you have previously had a gastric ulcer or stomach surgery - if you have liver problems or jaundice (yellowing of skin or eyes) - if you regularly see your doctor for serious complaints or conditions - if you are due to have an endoscopy or a breath test called a C-urea test. - if you have ever had a skin reaction after treatment with a medicine similar to SOMAC Control that reduces stomach acid.
Maltese: Kellem lit-tabib tiegħek qabel tieħu SOMAC Control - jekk kont ikkurat/a għal qrusa fl-istonku jew indiġestjoni kontinwament għal 4 ġimgħat jew iktar - jekk għandek iktar minn 55 sena u qed tieħu kura ta' kuljum għall-indiġestjoni mingħajr riċetta tat-tabib - jekk għandek iktar minn 55 sena u għandek sintomi tar-rifluss ġodda jew sintomi li nbidlu dan l-aħħar - jekk kellek operazzjoni minħabba ulċera gastrika jew tal-istonku - jekk għandek problemi tal-fwied jew suffejra (sfura tal-ġilda jew fl-għajnejn) - jekk regolarment tara lit-tabib tiegħek għal problemi jew kundizzjonijiet serji - jekk ser ikollok endoskopija jew test tan-nifs imsejjaħ C-urea test - jekk qatt kellek reazzjoni fil-ġilda wara kura b'mediċina simili għal SOMAC Control li tnaqqas l-aċtu fl-istonku.
English: See ‘Other medicines and SOMAC Control'.
Maltese: Ara “Mediċini oħra u SOMAC Control.
English: What SOMAC Control looks like and contents of the pack The gastro-resistant tablets are yellow, oval, biconvex film-coated tablets imprinted with “P20” on one side.
Maltese: Kif jidher SOMAC Control u l-kontenut tal-pakkett Il-pilloli gastro-reżistenti huma pilloli sofor, ovali, bikonvessi, miksija b'rita u stampati bi “P20” fuq naħa waħda.
English: Tabulated list of adverse reactions The following adverse reactions have been reported with pantoprazole.
Maltese: Lista f'tabella ta' reazzjonijiet avversiL-effetti mhux mixtieqa li ġejjin kienu rrappurtati bi pantoprazole.
English: Pharmacotherapeutic group: Drugs for acid related disorders Proton pump inhibitors, ATC code: A02BC02
Maltese: Inibituri tal-pompa tal-proton, Kodiċi ATC:
English: SOMAC Control contains the active substance pantoprazole, which blocks the ‘pump' that produces stomach acid.
Maltese: SOMAC Control fih is-sustanza attiva pantoprazole, li timblokka l-'pompa' li tipproduċi l-aċidu fl-istonku.
English: Takeda Italia S.p.A. Tel: +3906502601
Maltese: Tel: +3906502601
English: The increased CgA level may interfere with investigations for neuroendocrine tumours.
Maltese: Mediċini għal disturbi relatati mal-aċidu.
English: Do not take SOMAC Control: - if you are allergic to pantoprazole or to any of the other ingredients of this medicine (listed in section 6) - if you are taking HIV protease inhibitors such as atazanavir, nelfinavir (for the treatment of
Maltese: Tiħux SOMAC Control: - jekk inti allerġiku għal pantoprazole jew għal xi sustanza oħra ta' din il-mediċina (elenkati fis-sezzjoni 6). - jekk qed tieħu impedituri tal-protease ta' HIV bħal atazanavir; nelfavir (għal kura ta' infezzjoni bl-HIV).
English: Stop taking SOMAC Control when you are completely symptom-free.
Maltese: Għandek tieqaf tieħu SOMAC Control meta ma jkollokx aktar sintomi.
English: How to store SOMAC Control
Maltese: Jekk tinsa tieħu SOMAC Control
English: Do not take SOMAC Control with other medicines which limit the amount of acid produced in your stomach, such as another proton pump inhibitor (omeprazole, lansoprazole or rabeprazole) or an H2 antagonist (e.g. ranitidine, famotidine).
Maltese: Tiħux SOMAC Control ma' mediċini oħrajn li jillimitaw l-ammont ta' aċidu li jiġi prodott fl-istonku tiegħek, bħal inibitur tal-pompa tal-proton ieħor (omeprazole, lansoprazole jew rabeprazole) jew antagonist ta' H2 (eż. ranitidine, famotidine).
English: Therefore, in patients treated with coumarin anticoagulants (e.g. phenprocoumon or warfarin), monitoring of prothrombin time/INR is recommended after initiation, termination or during irregular use of pantoprazole.
Maltese: ‘Tiħux SOMAC Control'. - ketoconazole (użat għal infezzjonijiet fungali). - warfarin u phenprocoumon (jintużaw biex iraqqu d-demm u għall-prevenzjoni tal-emboli).
English: Tell your doctor immediately, before or after taking this medicine, if you notice any of the following symptoms, which could be a sign of another, more serious, disease: - an unintentional loss of weight (not related to a diet or an exercise programme) - vomiting, particularly if repeated - vomiting blood; this may appear as dark coffee grounds in your vomit - you notice blood in your stools; which may be black or tarry in appearance - difficulty in swallowing or pain when swallowing - you look pale and feel weak (anaemia) - chest pain - stomach pain - severe and/or persistent diarrhoea, because this medicine has been associated with a small increase in infectious diarrhoea.
Maltese: Għid lit-tabib tiegħek immedjatament, qabel jew wara li tieħu din il-mediċina, jekk tinnota kwalunkwe mis-sintomi li ġejjin, li jistgħu jkunu sinjal ta' marda oħra li tkun iktar serja: - telf ta' piż mhux intenzjonat (mhux marbut ma' dieta jew programm ta' eżerċizzju) - rimettar, partikularment jekk ikun ripetut - tirremetti d-demm; dan jista' jidher bħala frak tal-kafè skur fir-rimettar tiegħek - tinnota d-demm fl-ippurgar tiegħek; li jista' jidher iswed jew qisu qatran - diffikultà biex tibla' jew uġigħ meta tibla' - tidher musfar u tħossok dgħajjef (anemija) - uġigħ fis-sider - uġigħ fl-istonku - dijarea severa u/jew persistenti, għax din il-mediċina kienet assoċjata ma' żieda żgħira ta' dijarea infettiva - jekk ikollok raxx fuq il-ġilda tiegħek, speċjalment f'postijiet li jiġu esposti għax-xemx kellem lit-tabib tiegħek kemm jista' jkun malajr, peress li jista' jkollok bżonn twaqqaf il-kura tiegħek b'SOMAC Control.
English: SOMAC Control is indicated for short-term treatment of reflux symptoms (e.g. heartburn, acid regurgitation) in adults.
Maltese: SOMAC Control jintuża għal kura għal żmien qasir ta' sintomi tar-rifluss (per eżempju qrusa fl-istonku, rigurġitazzjoni tal-aċidu) fl-adulti.
English: You must not use SOMAC Control if you are taking HIV protease inhibitors.
Maltese: M'għandekx tuża SOMAC Control jekk qed tieħu impedituri tal-protease tal-HIV.
English: SOMAC Control is used for the short-term treatment of reflux symptoms (for example heartburn, acid regurgitation) in adults.
Maltese: SOMAC Control hu maħsub għal kura fuq perijodu ta' żmien qasir għas- sintomi ta' (eż. qrusa fl-istonku, rigurġitazzjoni tal-aċidu) fl-adulti.
English: Especially medicines containing one of the following active substances: - HIV protease inhibitors such as atazanavir, nelfinavir (for the treatment of HIV-infection).
Maltese: Partikolarment mediċini li fihom xi wieħed mis-sustanzi attivi li ġejjin:- impedituri tal-protease tal-HIV bħal atazanavir, nelfinavir (għat-trattament ta' infezzjoni ta'
English: The most commonly reported adverse reactions are diarrhoea and headache, both occuring in approximately 1% of patients.
Maltese: L-iktar reazzjonijiet avversili kienu rrappurtati b'mod komuni huma dijarea u wġigħ ta' ras, li t-tnejn iseħħu f'madwar 1% tal-pazjenti.
English: If you take SOMAC Control for longer periods, this may cause additional risks, such as:
Maltese: Jekk ser tieħu SOMAC Control għal perijodi itwal, dan jista' jikkaġuna riskji addizzjonali, bħal:
English: National Competent Authorities of Member State(s) or Reference Member State(s) if applicable shall ensure that the following conditions are fulfilled by the MAH(s):
Maltese: L-Awtoritajiet Nazzjonali Kompetenti tal-Istat(i) Membru(i) jew l-Istat(i) Membru(i) ta' Referenza jekk applikabbli, għandhom jiżguraw li l-kundizzjonijiet li ġejjin ikunu ssodisfati mill-MAH(s):
English: Tartrazine (E102)
Maltese: Tartrażin (E102)
English: 0.50 mg Equivalent to 0.6086 mg of halofuginone lactate
Maltese: 0.50 mg Ekwivalenti għal 0.6086 mg ta' halofuginone lactate
English: Bovine 10 μg/kg 25 μg/kg
Maltese: BOVINI 10 μg/kg
English: Date of first authorisation: 13/12/2016
Maltese: Data tal-ewwel awtorizazzjoni: 13/12/2016
English: Benzoic acid (E210) Lactic acid (E270) Tartrazine (E102) Water, Purified
Maltese: Aċidu benżojku (E210) Aċidu lattiku (E270) Tartrażin (E102
English: 08503 Gurb-Vic, Barcelona Spain
Maltese: 08503 Gurb-Vic, Barcelona
English: The concentrations to inhibit 50% and 90% of the parasites, in an in vitro test system, are IC50 < 0.1 μg/ml and IC90 of 4.5
Maltese: Il-konċentrazzjoni sabiex tinpedixxi 50% u 90% tal-parassiti f'testijiet li saru in vitro huwa ta' IC50 < 0.1 μg/ml u IC90 ta' 4.5 μg/ml, rispettivament.
English: Major incompatibilities
Maltese: .2 Inkompatibilitajiet maġġuri
English: Panon VetPharma Kft.
Maltese: Panon VetPharma
English: EMDOKA bvba John Lijsenstraat 16 B-2321 Hoogstraten Belgium
Maltese: EMDOKA bvba John Lijsenstraat 16 B-2321 Hoogstraten
English: Halofuginone (as lactate salt)
Maltese: Halofuginone (bħala melħ lactate)
English: Pull twice or three times, respectively, for administration of the desired volume (8 ml for calves of 35 - 45 kg and 12 ml for calves of 45 - 60 kg, respectively).
Maltese: Iġbed darbtejn jew tlieta, rispettivament, għall-amminstrazzjoni tal-volum mixtieq (8 ml għall għoġġiela ta' 35 - 45 kg u 12 ml għall-għoġġiela ta' 45 - 60 kg, rispettivament).
English: 0.03 mg For the full list of excipients, see section 6.1.
Maltese: 0.03 mg Għal-lista sħiħa tal-ingredjenti mhux attivi, ara sezzioni 6.1.
English: The active substance in HALAGON is an allowed substance as described in table 1 of the annex to Commission Regulation (EU) No 37/2010:
Maltese: Is-sustanza attiva f'HALAGON hija sustanza ammissibbli kif deskritt fit-tabella numru 1 fl-anness għarRegolament tal-Kummissjoni (UE) Nru 37/2010:
English: Benzoic acid (E210)
Maltese: Aċidu benżojku (E210)
English: • 35 kg < calves ≤ 45 kg: 8 ml of HALAGON once a day during 7 consecutive days
Maltese: • 35kg < għoġġiela ≤ 45kg : 8 ml HALAGON darba kuljum għal sebat ijiem konsekuttivi.
English: HALAGON 0.5 mg/ml oral solution halofuginone
Maltese: HALAGON 0.5mg/ml soluzzjoni orali. halofuginone
English: • 45 kg < calves < 60 kg: 12 ml of HALAGON once a day during 7 consecutive days
Maltese: • 45kg < għoġġiela < 60kg : 12 ml HALAGON darba kuljum għal sebat ijiem konsekuttivi.
English: Each bottle is sealed with a polypropylene cap. Each package also contains a 4 ml metering pump that consists of several components made out of high, low and linear low density polyethylene, polypropylene, stainless steel and silicone.
Maltese: Kull pakkett fih ukoll pompa talkejl ta' 4 ml li tikkonsisti minn diversi komponenti magħmula minn poli-etilin ta' densità għolja, baxxa u lineari b'densità baxxa, poli-propilen, azzar inossidabbli u silikonu.
English: Marketing Authorisation Holder: EMDOKA bvba John Lijsenstraat 16
Maltese: EMDOKA bvba J. Lijsenstraat 16
English: • Prevention of diarrhoea due to diagnosed Cryptosporidium parvum infection, in farms with history of cryptosporidiosis.
Maltese: • Prevenzjoni kontra dijareja kkawżata mill-infezzjoni Cryptosoridium pavarum,f'irziezet li għandhom storja ta' kriptosporidjosi.
English: The dosage is: 100 μg of halofuginone / kg bw / once a day for 7 consecutive days, i.e. 4 ml of HALAGON / 20 kg bw / once a day for 7 consecutive days.
Maltese: Id-doża hija ta': 100 μg ta' halofuginone/kg piż tal-ġisem/ darba kuljum għal sebat ijiem konsekuttivi, i.e. 4 ml ta' HALAGON / 20 kg piż tal-ġisem/ darba kuljum għal sebat ijiem konsekuttivi.
English: 71 08503 Gurb-Vic, Barcelona Spain
Maltese: Sant Hipolit, Km. 71 08503 Gurb-Vic, Barcelona Spanja
English: The active substance, halofuginone, is an antiprotozoal agent of the quinazolinone derivatives group (nitrogenous polyheterocycles).
Maltese: Is-sustanza attiva ħhalofuginone hija aġent anti-protożoiku li ġej mill-grupp tal-Quinazolinone
English: Arnika Veterina d.o.o.
Maltese: Arnika Veterina d.o.o. Vidikovac 20, 10000
English: Cardboard box containing one bottle (high-density polyethylene) of 290 ml, 490 ml or 980 ml of the oral solution.
Maltese: Kaxxa tal-kartun li fiha flixkun wieħed (poli-etilin ta' densita għolja) tal-290 ml, 490 ml jew 980 ml tassoluzzjoni orali.
English: The terminal elimination half-life is 11.7 hours after IV administration and 30.84 hours after single oral administration.
Maltese: Il-ħin sabiex nofs il-prodott ikun eliminat huwa ta' 11.7 siegħat wara somministrazzjoni fil-vina u ta' 30.84 siegħat meta jingħata f'doża waħda orali.
English: Cardboard box with high density polyethylene bottles of 290 ml, 490 and 980 ml.
Maltese: TAGĦRIF IEĦOR Kaxxa tal-kartun bi fliexken tal-poli-etilen ta' densità għolja ta' 290 ml, 490 u 980 ml.
English: Animal species MRLs
Maltese: DIKJARAZZJONI TAL-MRLs
English: Pharmacotherapeutic group: Other antiprotozoal agents, halofuginone.
Maltese: Aġenti anti-protożoiċi oħrajn, halofuginone Kodici ATĊ veterinarja:
English: Repetitive contact with the product may lead to skin allergies.
Maltese: Kuntatt ripetittiv mal-prodott jista' jikkawża allerġiji.
English: Excipients:
Maltese: Teл:
English: Symptoms of toxicity include diarrhoea, visible blood in faeces, decline in milk consumption, dehydration, apathy and prostration.
Maltese: Sintomi ta' tossiċita' jinkludu: dijareja, demm fil-ħmieġ, tnaqqis fl-aptit, l-annimali jixxotta, telqa u għejja.
English: Manufacturer responsible for batch release: Divasa-Farmavic, S.A.
Maltese: Isem u indirizz tal-manifattur responsabbli mill-ħruġ tal-lott Divasa-Farmavic, S.A.
English: • Reduction of diarrhoea due to diagnosed Cryptosporidium parvum infection.
Maltese: • Tnaqqis ta' inċidenza ta' dijareja ikkawżata mill-infezzjoni Cryptosoridium pavarum.
English: HALAGON 0.5 mg/ml oral solution for calves halofuginone (as lactate salt)
Maltese: VETERINARJU HALAGON 0.5 mg/ml soluzzjoni orali għall-għoġġiela halofuginone (bħala melħ lactate)
English: In newborn calves:
Maltese: Sustanzi mhux attivi:
English: Antiparasitic agents/Agents acting against protozoa
Maltese: Aġenti li jaġixxu kontra l protożoa
English: 2) Remove the protector cap from the nozzle.
Maltese: 2) Neħħi l-għatu protettiv minn maż-żennuna.
English: DD/MM/YYYY
Maltese: Dispożizzjoniji et oħrajn
English: Once the first calf has been treated, all the forthcoming new-born calves must be systematically treated as long as the risk for diarrhoea due to C. parvum persists.
Maltese: Jekk l-ewwel għoġol ikun ġie kkurat b'dan il-prodott, kull għoġol li jitwieled wara jrid jibqa' jiġi kkurat sistematikament sakemm ir-riskju ta' dijarea minn C.parvum jibqa' preżenti.
English: The time necessary to obtain the maximum concentration Tmax is 11 hours.
Maltese: L-ogħla konċentrazzjoni tintlaħaq (Tmax) fi 11-il siegħa.
English: HALAGON 0.5mg/ml oral solution for calves.
Maltese: VETERINARJU HALAGON 0.5mg/mL soluzzjoni orali għall-għoġġiela.
English: To ensure a correct dosage, an appropriate metering pump for administration of ‘HALAGON' is included.
Maltese: Sabiex jiġi żgurat dożaġġ korrett, hemm inkluż dożatur xieraq ta' “HALAGON”.
English: Halofugin one
Maltese: HALOFUGINONE HALOFU GINONE
English: The plasmatic concentrations of halofuginone after repeated oral administrations are comparable to the pharmacokinetic pattern after single oral treatment.
Maltese: Il konċentrazzjoni ta' halofuginone fil-plasma wara doża amministrata ripetutament b'mod orali hija simili għall-profil farmokinetiku ta' doża waħda. halofuginone mhux modifikat, huwa l-akbar komponent li wieħed isib fit-tessuti.
English: The compound has a cryptosporidiostatic effect on Cryptosporidium parvum.
Maltese: • Tnaqqis ta' dijarea kkawżata mill-infezzjoni Cryptosoridium pavarum.
English: The maximum concentration in plasma Cmax is 4 ng/ml.
Maltese: nanogrammi/millilitru.
English: 5) Pull the trigger of the metering pump completely for release of a dose that equals 4 ml of solution.
Maltese: Iġbed il-grillu tal-pompa tal-kejl kompletament għal rilaxx tad-doża li tkun daqs 4 ml ta' soluzzjoni.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Bottle of 290ml, 490 ml or 980 ml
Maltese: Flixkun ta' 290 ml, 490 ml jew 980 ml
English: 6) Put the protector cap back on the nozzle.
Maltese: 6) Erġa' waħħal l-għatu protettiv maż-żennuna.
English: HALAGON 0.5 mg/ml oral solution for calves
Maltese: HALAGON 0.5 mg/ml soluzzjoni orali għall-għoġġiela
English: If eye irritation persists, seek medical advice.
Maltese: Jekk l-irritazzjoni fl-għajnejn tippersisti, ara tabib.
English: Halofuginone lactate is a salt whose antiprotozoal properties and efficacy against Cryptosporidium parvum have been demonstrated both in in vitro conditions and in artificial and natural infections.
Maltese: Halofuginone lactate hija kimika li ġiet murija li għandha l-effett li toqtol il-protożoi tat-tip Cryptosoridium parvum kemm in vitro, kif ukoll f'infezzjonijiet artifiċjali u naturali.Is-sustanza għandha effett li twaqqaf it-tkabbir tal-kriptosporidja parvum.
English: Further information on Stayveer 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: Other information about Stayveer
Maltese: Informazzjoni oħra dwar Stayveer
English: Stayveer contains the active substance bosentan.
Maltese: Stayveer fih is-sustanza attiva bosentan.
English: Stayveer is available as film-coated tablets (62.5 mg and 125 mg).
Maltese: Stayveer jiġi bħala pilloli miksijin b'rita (62.5 mg u 125 mg).
English: In adults, the starting dose is 62.5 mg twice a day for four weeks, which is increased to the usual dose of 125 mg twice a day.
Maltese: Fl-adulti, id-doża tal-bidu hija 62.5 mg darbtejn kuljum għal erba' ġimgħat, u din tiżdied għad-doża normali ta' 125 mg darbtejn kuljum.
English: Stayveer received a marketing authorisation valid throughout the EU on 24 June 2013.
Maltese: Stayveer ingħata awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fl-24 ta' Ġunju 2013.
English: The active substance in Stayveer, bosentan, blocks a naturally occurring hormone called endothelin-1 (ET-1), which causes blood vessels to narrow.
Maltese: Is-sustanza attiva f'Stayveer, il-bosentan, timblokka ormon li jseħħ naturali msejjaħ endothelin-1 (ET1), li jikkawża tidjiq fil-vażi.
English: Similar results were seen in a study in 54 adults with class III PAH that was associated with congenital heart defects.
Maltese: Riżultati simili dehru fi studju fuq 54 adult bil-PAH tal-klassi III li kienet relatata ma' difetti tal-qalb konġenitali.
English: This is based on two studies in a total of 245 adults with class III or IV disease that was either primary or caused by scleroderma.
Maltese: Dan huwa bbażat fuq żewġ studji b'total ta' 245 adult b'marda tal-klassi III jew IV li kienet primarja jew ikkawżata minn skleroderma.
English: The company that makes Tracleer has agreed that its scientific data can be used for Stayveer (‘informed consent').
Maltese: Il-kumpanija li tipproduċi Tracleer qablet li d-data xjentifika tagħha tista' tintuża għal Stayveer (“kunsens infurmat”).
English: • caused by scleroderma (also called systemic sclerosis, a disease where there is abnormal growth of the connective tissue that supports the skin and other organs);
Maltese: • ikkawżata minn skleroderma (imsejħa wkoll sklerożi sistemika, marda fejn ikun hemm tkabbir anormali tat-tessut konnettiv li jissapportja l-ġilda u organi oħrajn);
English: Stayveer was more effective than placebo at reducing the development of new digital ulcers based on two studies in a total of 312 adults.
Maltese: Stayveer kien iktar effikaċi minn plaċebo fit-tnaqqis tal-iżvilupp ta' ulċeri ġodda fis-swaba', ibbażat fuq żewġ studji fuq total ta' 312-il adult.
English: However, Stayveer decreased the resistance to blood flow by 23%, indicating a widening of the blood vessels, compared with placebo after 6 months of treatment.
Maltese: Madankollu, Stayveer naqqas ir-reżistenza tal-vażi bi 23 %, u dan jindika twessigħ tal-vażi, meta mqabbel mal-plaċebo wara 6 xhur ta' kura.
English: What are the risks associated with Stayveer?
Maltese: X'inhuma r-riskji assoċjati ma' Stayveer?
English: As for all medicines, data on the use of Stayveer are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Stayveer hija ssorveljata kontinwament.
English: In the first study, patients taking Stayveer had an average of 1.4 new digital ulcers after 16 weeks, compared with 2.7 in the patients taking placebo.
Maltese: Fl-ewwel studju, il-pazjenti li kienu qed jieħdu Stayveer kellhom medja ta' 1.4 ulċeri ġodda fis-swaba' wara 16-il ġimgħa, meta mqabbla ma' 2.7 fil-pazjenti li kienu qed jieħdu plaċebo.
English: In a study in 185 patients with class II disease the distance the patients could walk over 6 minutes was similar in the Stayveer and placebo groups.
Maltese: II, id-distanza li l-pazjenti setgħu jimxu tul 6 minuti kienet simili għall-gruppi ta' Stayveer u tal-plaċebo.
English: The most common side effects with Stayveer (which may affect more than 1 in 10 people) are headache, fluid retention, anaemia (low levels of haemoglobin, the protein in red blood cells that carries oxygen around the body) and abnormal results of blood tests to check the liver.
Maltese: L-effetti sekondarji l-aktar komuni b'Stayveer (li jistgħu jaffettwaw aktar minn persuna waħda minn kull 10) huma wġigħ ta' ras, żamma tal-fluwidi, anemija (livelli baxxi ta' emoglobina, il-proteina fiċċelloli ħomor tad-demm li ġġorr l-ossiġnu madwar il-ġisem) u riżultati anormali ta' testijiet tad-demm biex jiġi kkontrollat il-fwied.
English: Side effects reported with Stayveer are carefully evaluated and any necessary action taken to protect patients.
Maltese: L-effetti sekondarji rrappurtati bi Stayveer huma evalwati bir-reqqa u kull azzjoni meħtieġa hi meħuda biex tipproteġi lill-pazjenti.
English: Stayveer is used to treat patients with class III pulmonary arterial hypertension (PAH) to improve exercise capacity (the ability to carry out physical activity) and reduce symptoms.
Maltese: Stayveer jintuża għall-kura ta' pazjenti b'ipertensjoni arterjali pulmonari (PAH) tal-klassi