FrancophonIA/ELRC3.0 huggingface dataset:
English: To stimulate active immunity against Staphylococcus aureus, coliforms and coagulase-negative staphylococci.
Maltese: Biex tistimula immunità attiva kontra Staphylococcus aureus, koliformi u coagulase-negative staphylococci.
English: Tel. +34 972 430660 Fax +34 972 430661 E-mail: hipra@hipra.com
Maltese: +34 972 430661 <{e-mail}> hipra@hipra.com
English: Liquid paraffin.............................................................................. 18.2 mg
Maltese: Paraffina likwida.............................................................................. 18.2 mg
English: EU/2/08/092/001 1 glass vial 1 dose EU/2/08/092/002 10 glass vials 1 dose EU/2/08/092/003 20 glass vials 1 dose EU/2/08/092/004 1 glass vial 5 doses EU/2/08/092/005 10 glass vials 5 doses EU/2/08/092/006 1 glass vial 25 doses EU/2/08/092/007 10 glass vials 25 doses EU/2/08/092/008 1 PET vial of 5 doses
Maltese: EU/2/08/092/004 kunjett tal-ħġieġ ta' 5 dożi EU/2/08/092/005 10 kunjetti tal-ħġieġ ta' 5 dożi EU/2/08/092/006 kunjett tal-ħġieġ ta' 25 doża EU/2/08/092/007 10 kunjetti tal-ħġieġ ta' 25 doża EU/2/08/092/008 kunjett tal-PET ta' 5 doses EU/2/08/092/009 kunjett tal-PET ta' 25 dożi EU/2/08/092/010 kunjett tal-PET ta' 125 dożi
English: Polyethylene (PET) vials of 10, 50 and 250 ml.
Maltese: Fliexken tal-Polyethylene (PET) ta' 10, 50 u 250 ml.
English: 1 vial of 1 dose (2 ml) 10 vials of 1 dose (2 ml) 20 vials of 1 dose (2 ml) 1 vial of 5 doses (10 ml) 10 vials of 5 doses (10 ml) 1 vial of 25 doses (50 ml) 10 vials of 25 doses (50 ml) 1 vial of 125 doses (250 ml) 125 doses (250 ml)
Maltese: kunjett 1 ta' doża (2ml) 10 kunjetti ta' doża (2 ml) 20 kunjett ta' doża (2 ml) kunjett 1 ta' 5 dożi (10 ml) 10 kunjetti ta' 5 dożi (10 ml) kunjett 1 ta' 25 doża (50 ml) 10 kunjetti ta' 25 doża (50 ml) kunjett 1 ta' 125 doża (250 ml) 125 doża (250 ml)
English: Benzyl alcohol…………….......................................................... 21 mg. For the full list of excipients, see section 6.1.
Maltese: Benzyl alcohol…………….......................................................... 21 mg
English: Date of first authorisation: 11/02/2009 Date of last renewal: 10/02/2014
Maltese: Data tal-aħħar tiġdid: 10/02/2014
English: la Selva, 135 17170 Amer (Girona) SPAIN
Maltese: S.A. Avda. la Selva, 135 17170 Amer (Girona) Spanja
English: One dose (2 ml) contains:
Maltese: (2 ml) fiha:
English: Excipient:
Maltese: Aġġuvant:
English: ATCvet code: QI02AB17.
Maltese: QI02 AB17)
English: Batch{number}
Maltese: Lott{numru}
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reactions) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Maltese: Il-frekwenza ta' effetti mhux mixtieqa hija definita skont din il-konvenzjoni: - komuni ħafna (aktar minn wieħed f'10 annimali li juru effetti mhux mixtieqa) - komuni (aktar minn wieħed iżda inqas minn 10 annimali f'100 annimal) - mhux komuni (aktar minn wieħed iżda inqas minn10 annimali f'1,000 annimal) - rari (aktar minn wieħed iżda inqas minn10 annimali f'10,000 annimal) - rari ħafna (inqas minn annimal wieħed f'10,000 annimal, inklużi rapporti iżolati).
English: HIPRA EΛΛAΣ A.E. Tηλ: (+30) 210 4978660
Maltese: Tηλ: (+30) 210 4978660
English: Pharmacotherapeutic group: Immunologicals for bovidae, inactivated bacterial vaccines for cattle.
Maltese: Immunoloġiċi għal bovidae, vaċċini batterjoloġiċi inattivati għall-bovini.
English: Laboratorios Hipra, S.A. Avda.
Maltese: LABORATORIOS HIPRA, S.A. Tel.
English: België/Belgique/Belgien
Maltese: België/Belgique/Belgien HIPRA BENELUX NV Tel:
English: 1 dose (2 ml) 5 doses (10 ml) 25 doses (50 ml)
Maltese: 25 dożi (50 ml)
English: EU/2/08/092/009 1 PET vial of 25 doses EU/2/08/092/010 1 PET vial of 125 doses
Maltese: EU/2/08/092/001 kunjett 1 tal-ħġieġ ta' doża EU/2/08/092/002 10 kunjetti tal-ħġieġ ta' doża
English: This veterinary medicinal product contains mineral oil.
Maltese: Dan il-prodott mediċinali veterinarju fih żejt minerali.
English: One dose contains: E. coli J5 inactivated; S. aureus (CP8) strain SP 140 inactivated.
Maltese: S.aureus (CP8) strejn SP140 inattivata.
English: INDICATION(S)
Maltese: U MANIFATTUR(I)
English: For herd immunisation of healthy cows and heifers, in dairy cattle herds with recurring mastitis problems, to reduce the incidence of sub-clinical mastitis and the incidence and the severity of the clinical signs of clinical mastitis caused by Staphylococcus aureus, coliforms and coagulase-negative staphylococci.
Maltese: Għat-tilqim ta' merħla baqar u erieħ b'saħħithom, f'merħliet ta' baqar tal-ħalib bi problemi ta' mastite rikorrenti, sabiex titnaqqas l-inċidenza ta' mastite sub-klinika u l-inċidenza u s-severità tas-sinjali kliniċi ta' mastite klinika kkawżata minn Staphylococcus aureus, koliformi u Stafilokoċċi li huma coagulase-negative.
English: Laboratorios Hipra S.A. Avda.
Maltese: Laboratorios Hipra
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard boxes, PET vial (250 ml)
Maltese: Kaxex tal-kartun, kunjetti tal-PET (250 ml)
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PET vials (10 ml, 50 ml) and glass vials (2 ml, 10 ml, 50 ml)
Maltese: Kunjetti tal-PET (10 ml, 50 ml) u kunjetti tal-ħġieġ (2 ml, 10 ml, 50 ml)
English: Administer one dose (2 ml) by deep intramuscular injection in the neck muscles at 45 days before the expected parturition date and 1 month thereafter administer a second dose (at least 10 days before calving).
Maltese: (2 ml) permezz ta' injezzjoni profonda ġol-muskoli fil-muskoli tal-għonq għal 45 jum qabel id-data mistennija tal-ħlas, u xahar wara dan agħti t-tieni doża (mill-inqas 10 ijiem qabel ilħlas).
English: Ivory-coloured homogeneous emulsion.
Maltese: Emulsjoni omoġenja kulur l-ivorju.
English: Escherichia coli (J5) inactivated .......................................................................... > 50 RED60* Staphylococcus aureus (CP8) strain SP 140 inactivated, expressing slime associated antigenic complex (SAAC)........................................................................ ........................................ > 50 RED80** * RED60: Rabbit effective dose in 60% of the animals (serology).
Maltese: Staphylococcus aureus (CP8) strejn SP140 inattivata, li tipproduċi kumpless antiġeniku assoċjat mal islajm (SAAC) ............................................................ ........................................ > 50
English: STARTVAC emulsion for injection for cattle
Maltese: VETERINARJU STARTVAC emulsjoni għal injezzjoni għall baqar
English: Pack sizes: - Cardboard box with 1, 10 and 20 glass vials of 1 dose.
Maltese: - Kaxxa tal-kartun b'1, 10 u 20 kunjett tal-ħġieġ ta' doża.
English: Type I colourless glass vials of 3, 10 and 50 ml.
Maltese: Kunjetti tal-ħġieġ bla kulur tat-Tip I ta' 3, 10 u 50 ml.
English: The full immunisation scheme induces immunity from approximately day 13 after the first injection until approximately day 78 after the third injection.
Maltese: L-iskema sħiħa tat-tilqim twassal għall-immunità minn bejn wieħed u ieħor jum 13 wara l-ewwel injezzjoni sa bejn wieħed u ieħor jum 78 wara t-tielet injezzjoni.
English: Escherichia coli J5 inactivated ............................................................................. > 50 RED60* Staphylococcus aureus (CP8) strain SP 140 inactivated, expressing slime associated antigenic complex (SAAC) ............. …………………………………………… > 50 RED80**
Maltese: Staphylococcus aureus (CP8) strejn SP 140 inattivat, li jipproduċi kumpless antiġeniku assoċjat mal islajm (SAAC) ................................ …………………………………………… > 50
English: STARTVAC is an ivory-coloured homogeneous emulsion for injection.
Maltese: STARTVAC huwa emulsjoni għal injezzjoni omoġena kulur l-ivorju.
English: Store and transport refrigerated (2 °C - 8 °C) and protected from light.
Maltese: Aħżen u ttrasporta fi friġġ (2 sa 8 °C) u ipproteġi mid-dawl.
English: Intramuscular use.
Maltese: Użu ġol-muskoli.
English: Immunisation has to be considered as one component in a complex mastitis control program that addresses all important udder health factors (e.g. milking technique, dry-off and breeding management, hygiene, nutrition, housing, bedding, cow comfort, air and water quality, health monitoring) and other management practices.
Maltese: It-tilqim għandu jiġi kkunsidrat bħala komponent wieħed fi programm kumpless ta' kontroll ta' mastite li jindirizza l-fatturi importanti kollha tas-saħħa tas-sider (eż. it-teknika tal-ħlib, maniġġjar tattnixxif u tgħammir, l-iġjene, l-ikel, l-akkomodazzjoni, il-friex, il-kumdità tal-baqra, il-kwalità tal-arja u tal-ilma, il-monitoraġġ tas-saħħa) u prattiċi oħra ta' maniġġjar.
English: The excipients (including adjuvants) listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Maltese: L-addittivi (inkluż l-aġġuvanti) elenkati f‘sezzjoni 6.1 tal-Karatteristiċi tal-Prodott fil-Qosor huma jew sustanzi ammissibbli li għalihom m'hemmx bżonn ta' limiti massimi ta' residwi kif indikat fit-tabella numru 1 tal-anness tar-Regolament tal-Kummissjoni (UE) Nru 37/2010 jew huma kunsidrati li ma jaqgħux fi ħdan l-iskop tar-Regolament (KE) Nru 470/2009 meta użati bħal f'dan il-prodott mediċinali veterinarju.
English: - A mean transient increase in body temperature of about 1 °C, in some cows up to 2 °C, may occur in the first 24 hours after injection based on post-authorisation pharmacovigilance reporting.
Maltese: - Żieda medja temporanja fit-temperatura tal-ġisem ta' madwar 1°C, f'xi baqar sa 2°C, tista' sseħħ flewwel 24 siegħa wara l-injezzjoni bbażat fuq ir-rapportar tal-farmakoviġilanza ta' wara lawtorizzazzjoni.
English: The injections should be preferably administered on the alternate sides of the neck.
Maltese: MOD TA' AMMINISTRAZZJONI Għal użu ġol-muskoli.
English: S. aureus (CP8) strain SP 140 inactivated, expressing slime associated antigenic complex (SAAC) > 50 RED80 (In 80% of the animals).
Maltese: RED60 (Doża effettiva għal fniek f'60 % tal-annimali (seroloġija)). S. aureus (CP8) strejn SP140 inattivata, li tipproduċi kumpless antiġeniku assoċjat mal-islajm (SAAC) > 50
English: Allow the vaccine to reach a temperature of 15 °C to 25 °C before administration.
Maltese: Ħalli l-vaċċin jilħaq temperatura +15 sa + 25 °C qabel jingħata.
English: QUANTITY OF THE ACTIVE SUBSTANCE(S)
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA
English: The active substances being a principle of biological origin intended to produce active immunity is not within the scope of Regulation (EC) No 470/2009.
Maltese: Is-sustanza attiva li hija prinċipju ta' oriġini bijoloġiku maħsuba sabiex tipproduċi immunità attiva ma taqgħax fi ħdan l-iskop tar-Regolament (KE) Nru 470/2009.
English: Emulsion for injection.
Maltese: GĦAMLA FARMAĊEWTIKA Emulsjoni għal injezzjoni.
English: Shelf life after first opening the immediate packaging: 10 hours stored at 15 °C to 25 ºC.
Maltese: Ladarba miftuħ, uża fi żmien 10 sigħat, maħżun f'temperatura ta' bejn +15 u + 25 ºC.
English: The full immunisation program should be repeated with each gestation.
Maltese: Il-programm sħiħ tat-tilqima għandu jkun ripetut ma kull tqala.
English: To the user:
Maltese: GĦAL:
English: E. coli J5 inactivated > 50 RED60 (Rabbit effective dose in 60% of the animals (serology)).
Maltese: E. coli J5 inattivat > 50
English: ** RED80: Rabbit effective dose in 80% of the animals (serology).
Maltese: Doża effettiva fil-fniek fi 80 % tal-annimali (seroloġija).
English: - Cardboard box with 1 PET vial of 5 doses.
Maltese: - Kaxxa tal-kartun b'kunjett 1 tal-ħġieġ ta' 5 dożi.
English: No adverse reactions other than those mentioned in section 4.6 were observed after the administration of a double dose of vaccine.
Maltese: Ebda reazzjoni avversa għajr dawk imsemmija fis-sezzjoni 4.6 ma ġiet osservata wara l-għoti ta' doża doppja tal-vaċċin.
English: - Cardboard box with 1 PET vial of 25 doses.
Maltese: - Kaxxa tal-kartun b'kunjett u b'10 kunjetti tal-ħġieġ ta' 25 doża.
English: Cardboard box with 20 glass vials of 1 dose.
Maltese: - Kaxxa tal-kartun b'20 kunjett tal-ħġieġ ta' doża 1.
English: Cardboard box with 10 glass vials of 5 doses.
Maltese: - Kaxxa tal-kartun b'10 kunjetti tal-ħġieġ ta' 5 dożi.
English: EU/1/16/1137/001 EU/1/16/1137/002 EU/1/16/1137/003 EU/1/16/1137/004 EU/1/16/1137/005
Maltese: EU/1/16/1137/001 EU/1/16/1137/002 EU/1/16/1137/003 EU/1/16/1137/004
English: 95% confidence interval
Maltese: 95% intervall ta' kunfidenza
English: Accord Healthcare Polska Sp.z o.o.,
Maltese: Accord Healthcare Polska Sp.z o.o., ul.
English: MedDRA system organ class (V.14.0)
Maltese: Sistema tal-klassifika tal-organi fid-database MedDRA (V.14.0)
English: Date of first authorisation: 14th November 2016
Maltese: Data ta' l-ewwel awtorizzazzjoni: 14 Novembru, 2016
English: 1047 Budapest Hungary
Maltese: 1047 Budapest L-ungerija
English: Wessling Hungary Kft Fòti ùt 56., Budapest 1047, Hungary or
Maltese: Wessling Hungary Kft Fòti ùt 56., Budapest 1047, L-Ungerija jew
English: The mean absolute oral bioavailability is 41% (range 25-63%).
Maltese: Il-medja assoluta ta' bijodisponibilità orali hija 41 % (medda 25-63 %).
English: Nicorandil is a hybrid of potassium channel activator and nitrate.
Maltese: Nicorandil huwa ibridu ta' attivatur tal-potassium channels u nitrate.
English: Vitamin K antagonists
Maltese: Antagonisti għall-vitamina K
English: Sage House, 319 Pinner Road, North Harrow, Middlesex HA1 4HF, United Kingdom or
Maltese: Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF Ir-Renju Unit jew
English: 5 years
Maltese: 5 snin.
English: Sildenafil is a weak inhibitor of the cytochrome P450 isoforms 1A2, 2C9, 2C19, 2D6, 2E1 and 3A4 (IC50 >150 µM).
Maltese: Sildenafil huwa inibitur dgħajjef ta' ċitokromju P450 iżoformi 1A2, 2C9, 2C19, 2D6, 2E1 u 3A4 ( 1C50 > 150 µM).
English: - Medicines containing nitrates, or nitric oxide donors such as amyl nitrate (“poppers”).
Maltese: - Mediċini li fihom nitrati, jew donaturi ta' nitric oxide bħal amyl nitrite (“poppers”).
English: - if you are taking riociguat.
Maltese: - qed/a tieħu riociguat.
English: Intensified monitoring is recommended during the discontinuation period.
Maltese: Huwa rrakomandat monitoraġġ intensiv waqt il-perijodu ta' twaqqif.
English: Clinical efficacy and safety
Maltese: Effikaċja klinika u ta' sigurtà
English: Severe hepatic impairment,
Maltese: Indeboliment epatiku gravi,
English: Sildenafil is rapidly absorbed.
Maltese: Sildenafil jiġi assorbit malajr.
English: Treatment group
Maltese: Grupp tat-trattament
English: Other medicines and Granpidam
Maltese: Mediċini oħra u Granpidam
English: n=29 for placebo group
Maltese: n=29 għal grupp li qed jirċievu il-plaċebo
English: Effects of other medicinal products on sildenafil
Maltese: Effetti ta' prodotti mediċinali oħra fuq sildenafil
English: Granpidam is contraindicated in patients with severe hepatic impairment (Child-Pugh class C) (see section 4.3).
Maltese: Granpidam huwa kontra-indikat f'pazjenti b'indeboliment renali ta' natura gravi (Child-Pugh klassi C) (ara sezzjoni 4.3).
English: The respective odds ratios were 2.92 (p=0.0087), 4.32 (p=0.0004) and 5.75 (p<0.0001).
Maltese: Il-meded talfard rispettivi kienu 2.92 (p=0.0087), 4.32 (p=0.0004) u 5.75 (p<0.
English: Lactose monohydrate is present in the tablet film coat.
Maltese: Lactose monohydrate huwa preżenti fil-kisja tal-pillola.
English: Serious adverse events were reported in 94 (41%) of the 229 subjects receiving sildenafil.
Maltese: Avvenimenti avversi serji kienu rrapurtati f'94 (41%) suġġett minn 229 suġġett li qed jirċievu sildenafil.
English: Placebo-corrected treatment effects with PVR were -178 dyne.sec/cm5 (p=0.0051), -195 dyne.sec/cm5 (p=0.0017) and -320 dyne.sec/cm5 (p<0.0001) for sildenafil 20 mg, 40 mg and 80 mg TID,
Maltese: L-effetti tat-trattament ikkoreġut bi plaċebo f'PVR kien ta' -178 dyne.sec/cm5 (p=0.0051), -195 dyne.sec/cm5 (p=0.0017) u -320 dyne.sec/cm5 (p<0.
English: Granpidam 20 mg film-coated tablets are also provided in PVC/Alu perforated unit dose blister packs containing 15x1, 90x1 and 300x1 tablets.
Maltese: Granpidam pilloli miksija b'rita 20 mg huma wkoll provduti f'pakketti b'folji unit dose perforata PVC / Alu li fihom 15x1, 90x1 u 300x1 pilloli.
English: Infections and infestations Common cellulitis, influenza, bronchitis, sinusitis, rhinitis, gastroenteritis
Maltese: Reazzjonijiet avversi cellulite, influwenza, bronkite, sinusite, rinite, gastroenterite anemija ritenzjoni tal-likwidi insomnja, ansjeta
English: Tablet core: microcrystalline cellulose, anhydrous calcium hydrogen phosphate, croscarmellose sodium, hypromellose (5cp) (E464), magnesium stearate
Maltese: Qalba tal-pillola: microcrystalline cellulose, anydrous calcium hydrogen phosphate , croscarmellose sodium, hypromellose (5cp) (E464), magnesium stearate.
English: For class II and class III, placebo corrected increases of 49 metres (p = 0.0007) and 45 metres (p = 0.0031) were observed respectively.
Maltese: Għall-klassi II u III, żidiet korretti bi plaċebo ta' 49 metru (p = 0.0007) u 45 metru (p = 0.0031) kienu rispettivament osservati.
English: The percent reduction at 12 weeks for sildenafil 20 mg, 40 mg and 80 mg TID in PVR (11.2%, 12.9%, 23.3%) was proportionally greater than the reduction in systemic vascular resistance (SVR) (7.2%, 5.9%, 14.4%).
Maltese: Il-perċentwali ta' tnaqqis fit-12-il ġimgħa għal sildenafil 20 mg, 40 mg u 80 mg TID f'PVR (11.2 %, 12.9 %, 23.3 %) kien proporzjonalment ikbar mit-tnaqqis fir-reżistenza sistemika vaskolari (SVR) (7.2 %, 5.9 %, 14.4 %).
English: Elderly (≥65 years)
Maltese: Użufl-anzjani(≥65sena)
English: This metabolite has a phosphodiesterase selectivity profile similar to sildenafil and an in vitro potency for PDE5 approximately 50% that of the parent drug.
Maltese: Dan il-metabolu għandu profil selettiv ta' phosphodiesterase simili għal sildenafil u potenza in vitro għal PDE5 bejn wieħed u ieħor 50 % ta' dik tal-mediċina mhux mibdula.
English: Granpidam contains the active substance sildenafil which belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors.
Maltese: Granpidam fih is-sustanza attiva sildenafil li tifforma parti minn grupp ta' mediċinali msejħa inibituri ta' phosphodiesterase type 5 (PDE 5).
English: For dose recommendations, see sections 4.2 and 4.3.
Maltese: Għal rakommandazzjonijiet tad-dożi, ara sezzjonijiet 4.2 u 4.3.
English: The results of the main analysis (combined dose groups versus placebo) were not statistically significant (p = 0.056) (see Table 2).
Maltese: Ir-riżultati tal-analiżi prinċipali (gruppi li qed jirċievu dożi differenti mqabbla mal-plaċebo) ma kienux statistikament sinifikanti (p = 0.056) (ara Tabella 2).
English: Efficacy of sildenafil should be closely monitored in patients using concomitant potent CYP3A4 inducers, such as carbamazepine, phenytoin, phenobarbital, St John's wort and rifampicine.
Maltese: L-effikaċja ta' sildenafil għandha tkun immonitorjata mill-qrib f'pazjenti li qed jużaw indutturi qawwijin ta' CYP3A4 fl-istess ħin, bħal carbamazepine, phenytoin, phenobarbital, St John's wort u rifamipicin.
English: Film coat: hypromellose (15cp) (E464), titanium dioxide (E171), lactose monohydrate, triacetin.
Maltese: Kisja b'rita: hypromellose (15cp) (E464), titanium dioxide (E171), lactose monohydrate, triacetin.
English: The corresponding additional reduction in supine diastolic blood pressure was 7 mmHg.
Maltese: It-tnaqqis addizzjonali korrespondenti ma' pressjoni għolja supine diastolic kienet ta' 7 mmHg.
English: Sildenafil and its major circulating N-desmethyl metabolite are approximately 96% bound to plasma proteins.
Maltese: Sildenafil u l-metabolit maġġur tiegħu fiċ-ċirkolazzjoni, N-desmethyl, huma bejn wieħed u ieħor 96 % marbutin malproteini tal- plażma.
English: Each tablet also contains 0.2 mg of lactose (as monohydrate).
Maltese: Kull pillola fiha wkoll 0.2 mg ta' lactose (bħala monohydrate).
English: HA1 4HF
Maltese: G04B E03
English: In these study populations, mean additional reductions of supine systolic and diastolic blood pressure of 7/7 mmHg, 9/5 mmHg, and 8/4 mmHg, respectively, and mean additional reductions of standing blood pressure of 6/6 mmHg, 11/4 mmHg, and 4/5 mmHg, respectively were observed.
Maltese: F'dawn ilpopolazzjonijiet ta' l- istudju, ġie osservat tnaqqis addizzjonali medju fil-pressjoni supine systolic u l-pressjoni diastolic ta' 7/7 mmHg, 9/5 mmHg u 8/4 mmHg, rispettivament, u tnaqqis addizzjonali medju fil-pressjoni tad- demm bil-wieqfa ta' 6/6 mmHg, 11/4 mmHg u 4/5 mmHg rispettivament.
English: A mean placebo-corrected treatment effect of -3.9 mmHg was observed in favour of sildenafil (95% CI: -5.7, -2.1) (p = 0.00003).
Maltese: Trattament medju kkoreġut bl-effett ta' plaċebo ta' 3.9 mmHg ġie osservat favur sildenafil (95% CI: -5.7, -2.1) (p=0.00003).
English: In the placebo-controlled study of sildenafil in patients 1 to 17 years of age with pulmonary arterial hypertension, a total of 174 patients were treated three times a day with either low (10 mg in patients >20 kg; no patients ≤20 kg received the low dose), medium (10 mg in patients ≥8-20 kg; 20 mg in patients ≥20-45 kg; 40 mg in patients >45 kg) or high dose (20 mg in patients ≥8-20 kg; 40 mg in patients ≥20-45 kg; 80 mg in patients >45 kg) regimens of sildenafil and 60 were treated with placebo.
Maltese: Fi studju kliniku kkontrollat bil-plaċebo ta' sildenafil f'pazjenti ta' età ta' bejn sena u 17-il sena bi pressjoni għolja arterjali tal-pulmun, total ta' 174 pazjent kienu ttrattati tlett darbiet kuljum b'doża baxxa (10 mg f'pazjenti ta' > 20 kg; l-ebda pazjent ta' ≤ 20 kg ma ġie mogħti d-doża baxxa), jew b'doża medja (10 mg f'pazjenti ta' ≥ 8-20 kg; 20 mg f'pazjenti ta' ≥ 20-45 kg; 40 mg f'pazjenti ta' > 45 kg) jew b'doża għolja (20 mg f'pazjenti ta' ≥ 8-20 kg; 40 mg f'pazjenti ta' ≥ 20-45 kg; 80 mg f'pazjenti ta' > 45 kg) ta' sildenafil filwaqt li 60 pazjent kienu ttrattati bil-plaċebo.
English: Granpidam 20 mg
Maltese: Granpidam 20 mg pilloli
English: In three specific drug-drug interaction studies, the alpha-blocker doxazosin (4 mg and 8 mg) and sildenafil (25 mg, 50 mg, or 100 mg) were administered simultaneously to patients with benign prostatic hyperplasia (BPH) stabilized on doxazosin therapy.
Maltese: Fi tlett studji speċifiċi fuq interazzjonijiet bejn droga u droga, l-alpha blocker doxazosin (4 mg u 8 mg) u sildenafil (25 mg, 50 mg, jew 100 mg) ġew amministrati fl-istess waqt, lil pazjenti bi iperplażja beninn tal-prostata (BPH) stabbilizzati b'kura b'doxazosin.
English: Results were generally consistent in subgroups according to aetiology (primary and connective tissue disease-associated PAH), WHO functional class, gender, race, location, mean PAP and PVRI.
Maltese: Ir-riżultati kienu ġeneralment konsistenti f'sottogruppi skont,l-etjoloġijja (primarja u PAH assoċjat ma' mard tat-tessut konnettiv), klassi funzjonali tal-WHO, sess, razza, post, medja ta' PAP u PVRI.
English: For dose recommendations, see section 4.2.
Maltese: Għal rakommandazzjonijiet tad-dożi, ara sezzjoni 4.2.
English: Odds ratios for the sildenafil low, medium and high dose groups compared to placebo were 0.6 (95% CI: 0.18, 2.01), 2.25 (95% CI: 0.75, 6.69) and 4.52 (95% CI: 1.56, 13.10), respectively.
Maltese: Il-proporzjonijiet ta' probabilità għall-gruppi li qed jirċievu doża baxxa, medja u għolja ta' sildenafil meta mqabbla ma dawk li qed jirċievu plaċebo kienu 0.6 (95% CI: 0.18, 2.01), 2.25 (95% CI: 0.75, 6.69) u 4.52 (95% CI: 1.56, 13.10), rispettivament.
English: Dose related improvements were observed with pulmonary vascular resistance index (PVRI) and mean pulmonary arterial pressure (mPAP).
Maltese: Titjib relatat mad-doża fl-indiċi tar-reżistenza vaskulari pulmonari (PVRI) u l-pressjoni medja arterjali tal-pulmun (mPAP) kien osservat.