FrancophonIA/ELRC3.0 huggingface dataset:
English: • Diane 35 and its generics should only be used for the treatment of moderate to severe acne related to androgen-sensitivity (with or without seborrhoea) and/or hirsutism, in women of reproductive age.
Maltese: • Diane 35 u l-mediċini ġeneriċi tiegħu għandhom jintużaw biss għall-kura ta' akne moderata sa severa relatata ma' sensittività għall-androġen (bi jew mingħajr saborrea) u/jew l-irsutiżmu, f'nisa ta' età riproduttiva.
English: The PRAC recommendations were sent to the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh), which adopted a final position.
Maltese: Ir-rakkomandazzjonijiet tal-PRAC intbagħtu lill-Grupp ta' Koordinazzjoni għal Proċedura tar-Rikonoxximent Reċiproku u l-Proċedura Deċentralizzata - Bniedem (CMDh), li adotta pożizzjoni finali.
English: The review of Diane 35 and its generics was triggered by the French medicines agency, the National Agency for the Safety of Medicine and Health Products (ANSM), following its decision to suspend Diane 35 and its generics in France within three months.
Maltese: Ir-reviżjoni ta' Diane 35 u l-mediċini ġeneriċi tiegħu nbdiet mill-aġenzija tal-mediċini Franċiża, lAġenzija Nazzjonali għas-Sigurtà tal-Prodotti Mediċinali u tas-Saħħa (ANSM), wara d-deċiżjoni tagħha li tissospendi Diane 35 u l-mediċini ġeneriċi tiegħu fi Franza fi żmien tliet xhur.
English: • Since Diane 35 and its generics act also as hormonal contraceptives, they should not be used in combination with other hormonal contraceptives.
Maltese: • Billi Diane 35 u l-mediċini ġeneriċi tiegħu jaġixxu wkoll bħala kontraċettivi ormonali, huma m'għandhomx jintużaw flimkien ma' kontraċettivi ormonali oħra.
English: • Healthcare professionals will be sent a letter with further details.
Maltese: • Il-professjonisti tal-kura tas-saħħa ntbagħtitilhom ittra b'aktar dettalji.
English: The efficacy in moderate and severe acne with or without seborrhoea and /or hirsutism is demonstrated in more than 30 clinical trials.
Maltese: L-effikaċja f'akne moderata u severa bi jew mingħajr saborrea u/jew flirsutiżmu ntweriet f'aktar minn 30 prova klinika.
English: Furthermore, Diane 35 and generics should only be used for the treatment of acne when alternative treatments, such as topical therapy and antibiotic treatment, have failed.
Maltese: Barra minn hekk, Diane 35 u l-mediċini ġeneriċi tiegħu għandhom jintużaw biss għall-kura ta' akne meta tipi ta' kura alternattivi, bħal terapija topikali u kura bl-antibijotiċi, ma jkunux ħadmu.
English: Cyproterone also supresses ovulation and therefore has a contraceptive effect.
Maltese: Cyproterone jissoprimi wkoll l-ovulazzjoni u għalhekk għandu effett kontraċettiv.
English: • The review also showed that the excess risk of VTE is highest during the first year of use of Diane 35 and its generics or when restarting or switching from an oral hormonal contraceptive to Diane 35 and its generics after a pill-free interval of at least one month.
Maltese: • Ir-reviżjoni wriet ukoll li r-riskju miżjud ta' VTE huwa l-ogħla matul l-ewwel sena ta' użu ta' Diane 35 u l-mediċini ġeneriċi tiegħu jew meta jerġa' jinbeda jew issir qalba minn kontraċettiv ormonali orali għal Diane 35 u l-mediċini ġeneriċi tiegħu wara intervall ta' mill-anqas xahar mingħajr pilloli.
English: These medicines should be used solely in the treatment of moderate to severe acne related to androgen sensitivity and/or hirsutism (excessive unwanted growth of hair in women) in women of reproductive age.
Maltese: Dawn il-mediċini għandhom jintużaw biss fil-kura ta' akne moderata sa severa relatata ma' sensittività għall-androġen u/jew l-irsutiżmu (tikbir eċċessiv mhux mixtieq tax-xagħar fin-nisa) f'nisa ta' età riproduttiva.
English: 10 x 1 dose 50 x 1 dose
Maltese: 10 x 1 doża 50 x 1 doża
English: ATCvet code: QI06AH07.
Maltese: QI06AH07.
English: PL : Polska VIRBAC Sp. z o.o.
Maltese: PL : Polska VIRBAC Sp. z o.o. ul.
English: Suspension:
Maltese: Suspensjoni:
English: Date of last renewal: 06/06/2014.
Maltese: Data tal-aħħar tiġdid: 06/06/2014.
English: Αθηνών - Λαμίας, T.K.14452, Μεταμόρφωση , Ελλάδα
Maltese: VIRBAC Hellas SA 13o χλμ Ε.Ο. Αθηνών - Λαμίας, T.K.14452, Μεταμόρφωση , Ελλάδα
English: NL: Nederland VIRBAC Nederland BV Hermesweg 15
Maltese: Nederland VIRBAC Nederland BV Hermesweg 15
English: AT: Österreich VIRBAC Österreich GmbH Hildebrandgasse 27
Maltese: Österreich VIRBAC Österreich GmbH Hildebrandgasse 27
English: EU/2/09/097/001 EU/2/09/097/002
Maltese: EU/2/09/097/002
English: Lot {number}
Maltese: Lott {numru}
English: * Cell culture infectious dose 50%.
Maltese: * Doża infettiva ta' kultura ta' ċelloli 50% Suspensjoni:
English: Minimum quantity of purified p45 FeLV-envelope antigen
Maltese: Kwantità minima ta' antiġen p45 FeLV-envelope purifikat
English: FI: Suomi/Finland VIRBAC
Maltese: Suomi/Finland VIRBAC
English: IS: Ísland
Maltese: Ísland
English: 06517 Carros France service-conso@virbac.fr
Maltese: FR: France VIRBAC France 13e rue LID 06517 Carros France service-conso@virbac.fr
English: NO: Norge
Maltese: Norge
English: Vaccine against feline viral rhinotracheitis, feline calicivirosis, feline panleucopenia and feline leukaemia.
Maltese: Vaċċin kontra r-rinotrakeite virali feline viral rhinotracheitis, feline calicivirosis, feline panleucopenia u feline leukaemia.
English: ROUTE(S) OF ADMINISTRATION
Maltese: MOD(I) TA' AMMINISTRAZZJONI
English: Adjuvants: 3% aluminium hydroxide gel expressed as mg Al
Maltese: Adjuvanti: 3 % ġel idrossidu tal-aluminjum rappreżentat bħala mg Al
English: METHOD AND ROUTE(S) OF ADMINISTRATION
Maltese: METODU U MOD(I) TA' AMMINISTRAZZJONI
English: Pharmacotherapeutic group: immunologicals for Felidae, live and inactivated viral vaccines for cats.
Maltese: Grupp farmakoterapewtiku: immunoloġiċi għall-Felidae, vaċċini virali attivi u inattivati għall-qtates.
English: Lyophilisate:
Maltese: Lijofilizzat:
English: Purified extract of Quillaja saponaria
Maltese: Estratt purifikat ta' Quillaja saponaria
English: For active immunisation of cats from eight weeks of age against:
Maltese: Għall-immunizzazzjoni attiva tal-qtates minn età ta' tmien ġimgħat kontra:
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 ddefinita bl-użu tal-konvenzjoni li ġejja: - komuni ħafna (aktar minn wieħed f'10 annimali kkurati li juru effetti mhux mixtieqa) - komuni (aktar minn wieħed iżda inqas minn 10 annimali f'100 annimal ikkurat) - mhux komuni (aktar minn wieħed iżda inqas minn10 annimali f'1,000 annimal ikkurat) - rari (aktar minn wieħed iżda inqas minn10 annimali f'10,000 annimal ikkurat) - rari ħafna (inqas minn annimal wieħed f'10,000 annimal ikkurat, inklużi rapporti iżolati).
English: Sodium chloride Disodium phosphate anhydrous Potassium dihydrogen phosphate Aluminium hydroxide gel Quillaja saponaria Water for injections
Maltese: Klorur tas-sodju Fosfat anidru tad-dissodju Fosfat di-idroġenu tal-potassju Ġell idrossidu tal-aluminju Quillaja saponaria
English: HR: Hrvatska VIRBAC
Maltese: HR: Hrvatska
English: Plastic or cardboard box of 10 lyophilisate vials and 10 suspension vials.
Maltese: Kaxxa tal-plastik jew tal-kartun ta' 10 kunjetti ta' lijofiliżat u 10 kunjetti ta' suspensjoni.
English: LV: Latvija
Maltese: Latvija
English: Lyophilisate and suspension for suspension for injection.
Maltese: Lijofilizat u suspensjoni għal suspensjoni għal injezzjoni.
English: Live attenuated feline panleucopenia virus (strain LR 72)
Maltese: Virus ħaj inattivat tal-panlewkopenja felina (razza LR 72)
English: BG: Република България VIRBAC
Maltese: Република България VIRBAC
English: Plastic or cardboard box of 50 lyophilisate vials and 50 suspension vials.
Maltese: Kaxxa tal-plastik jew tal-kartun ta' 50 kunjett ta' lijofiliżat u 50 kunjett ta' suspensjoni.
English: Suspension: Opalescent liquid.
Maltese: Kulur abjad Solvent: Likwidu opalexxenti.
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)
Maltese: Il-frekwenza ta' effetti mhux mixtieqa hija ddefinita bl-użu tal-konvenzjoni li ġejja: - komuni ħafna (aktar minn wieħed f'10 annimali kkurati li juru effetti mhux mixtieqa) - komuni (aktar minn wieħed iżda inqas minn 10 annimali f'100 annimal ikkurat) - mhux komuni (aktar minn wieħed iżda inqas minn10 annimali f'1,000 annimal ikkurat)
English: INDICATION(S)
Maltese: MANIFATTUR(I)
English: Live attenuated feline viral rhinotracheitis virus (strain F2)
Maltese: Virus ħaj inattivat tar-rinotrakeite felina (razza F2)
English: LEUCOFELIGEN FeLV/RCP, lyophilisate for cats
Maltese: FeLV/RCP lijofiliżat għal qtates
English: CY: Κύπρος
Maltese: Κύπρος
English: The onset of immunity has been demonstrated from: - 3 weeks after the primary vaccination for the panleucopenia and leukaemia components - 4 weeks after the primary vaccination for the calicivirus and rhinotracheitis virus components.
Maltese: Il-bidu tal-immunità kien dimostrat minn: - 3 ġimgħat wara t-tilqima primarja għal komponenti tal-panlewkopenia u lewkimja, - 4 ġimgħat wara t-tilqima primarja għal komponenti tal-kaliċivirosi u tal-virus tar-rinotrakeite.
English: Excipient: Stabilizing buffer containing gelatin to 1.3 ml before freeze-drying
Maltese: Baffer stabbilizzanti li fih il-ġelatina sa 1.3 ml qabel ma jitnixxef bil-friża
English: QUANTITY OF THE ACTIVE SUBSTANCE(S)
Maltese: TAS-SUSTANZA(I) ATTIVA(I)
English: LYOPHILISATE VIAL
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ
English: No adverse reactions were observed after an overdose administration (10 doses of lyophilisate and 2 doses of suspension) of the veterinary medicinal product other than those mentioned in section 4.6 except local reactions that can last longer (from 5 to 6 weeks at the most).
Maltese: L-ebda reazzjonijiet mhux mixtieqa ma kienu osservati wara amministrazzjoni ta' doża eċċessiva (10 dożi ta' lajofiżejt u 2 dożi ta' suspensjoni) tal-prodott mediċinali veterinarju barra minn dawk imsemmija f'sezzjoni 4.6 b'eċċezzjoni ta' reazzjonijiet lokali li jistgħu jdumu aktar (minn 5 sa 6 ġimgħat l-aktar).
English: A moderate and transient local reaction (<2 cm) is commonly observed after the first injection.
Maltese: Reazzjoni lokali moderata u momentarja (<2 cm) tiġi osservata b'mod komuni wara l-ewwel injezzjoni.
English: Reconstitute one dose of lyophilisate with one dose (1ml) of suspension, shake gently and administer immediately.
Maltese: Irrikostitwixxi doża waħda ta' lijofiliżat ma' doża waħda (1 ml) ta' suspensjoni, ħawwad b'mod ġentili u amministra immedjatament.
English: In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
Maltese: Fin-nuqqas ta' studji dwar kompattibilità, dan il-prodott mediċinali veterinarju ma jistax jitħallat flimkien ma' prodotti mediċinali veterinarji oħra.
English: Special precautions for use in animals:
Maltese: Kodici veterinarja ATC:
English: SI: Slovenija VIRBAC
Maltese: Slovenija VIRBAC
English: Gelatin
Maltese: Qtates
English: Date of first authorisation: 25/06/2009.
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI / TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 25/06/2009.
English: CZ : Česká republika VIRBAC
Maltese: Česká republika VIRBAC
English: The antigenic suspension is adjuvanted with an aluminium hydroxide gel and with a purified extract of Quillaja saponaria.
Maltese: Is-suspensjoni antiġenika hi megħjuna minn ġel idrossidu tal-aluminju u b'estratt purifikat ta' Quillaja saponaria
English: - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Maltese: - rari (aktar minn wieħed iżda inqas minn10 annimali f'10,000 annimal ikkurat) - rari ħafna (inqas minn annimal wieħed f'10,000 annimal ikkurat, inklużi rapporti iżolati).
English: This local reaction could be a swelling, an oedema or a nodule and resolves spontaneously within from 3 to 4 weeks at the most.
Maltese: Din ir-reazzjoni lokali tista' tkun nefħa, edema jew għoqda u tirriżolvi spontanjament fi żmien 3 sa 4 ġimgħat l-iżjed.
English: For the leukaemia component, protection against persistent viraemia is observed in 73% of cats 3 weeks after their first vaccine injection.
Maltese: Għall-komponent tal-lewkimja, il-protezzjoni kontra l-viraemija persistenti hija osservata fi 73% talqtates tliet ġimgħat wara l-ewwel tilqima.
English: - feline viral rhinotracheitis to reduce clinical signs and viral excretion, - feline panleucopenia to prevent leucopenia and to reduce clinical signs, - feline leukaemia to prevent persistent viraemia and clinical signs of the related disease.
Maltese: - kaliċivirosi felina biex tnaqqas sinjali kliniċi, - rinotrakeite virali felina biex tnaqqas sinjali kliniċi u t-tneħħija virali, - panlewkopenja felina biex timpedixxi lewkopenja u tnaqqas sinjali kliniċi, - lewkimja felina biex timpedixxi viremija persistenti u sinjali kliniċi tal-marda relatata.
English: ul.
Maltese: UŻU
English: Store and transport refrigerated (2 C - 8 C).
Maltese: Aħżen u ttrasporta ġo friġġ (2 ºC - 8 ºC) Tiffriżax.
English: Name and address of the manufacturers of the biological active substances
Maltese: Isem u indirizz tal-manufatturi tas-sustanzi bijoloġiċi attivi
English: Lyophilisate: White pellet.
Maltese: Tagħmlux fil-friża.
English: Live attenuated feline calicivirus (strain F9)
Maltese: Virus ħaj inattivat tal-kaliċivirus felin (razza F9)
English: Box of 10 or 50 lyophilisate vials and 10 or 50 suspension vials
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ IL-PAKKETT TA' BARRA Kaxxa ta' 10 jew 50 kunjett ta' lijofilizat u 10 jew 50 kunjett ta' suspensjoni.
English: 1.3 ml before freeze-drying
Maltese: 1.3 ml qabel ma jitnixxef u ffriżat
English: LEUCOFELIGEN FeLV/RCP lyophilisate and suspension for suspension for injection for cats
Maltese: FeLV/RCP lijofilizzat u suspensjoni għal suspensjoni għal injezzjoni fil-qtates
English: Per dose of 1 ml:
Maltese: Kull doża ta' 1 ml:
English: Type I glass vial containing one dose (1 ml) of the adjuvanted liquid, with a 13 mm-diameter butyl elastomer stopper and set with an aluminium capsule.
Maltese: Kunjett tal-ħġieġ ta' tip I li fih doża waħda (1 ml) ta' likwidu aġġuvanti, magħluq b'tapp tal-lastku talbutil b'dijametru ta' 13mm u miksi b'kapsula tal-aluminjum.
English: SE: Sverige
Maltese: Sverige
English: Excipient: Buffered isotonic solution to
Maltese: Sustanza mhux attiva Soluzzjoni isotonika newtralizzata għal
English: WITHDRAWAL PERIOD(S)
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I)
English: 1ère avenue 2065 m L.I.D 06516 Carros France
Maltese: 1ère avenue 2065 m L.I.D 06516 Carros Franza
English: Sodium chloride
Maltese: VETERINARJU LEUCOFELIGEN
English: Administer subcutaneously one dose (1 ml) of the veterinary medicinal product according to the following regimen of vaccination.
Maltese: Amministra taħt il-ġilda (1 ml), doża waħda tal-prodott mediċinali veterinarju skont ir-reġimen tattilqim li ġej.
English: Potassium hydroxide Lactose monohydrate Glutamic acid
Maltese: Idrossidu tal-potassju Monoidrat tal-lattosju Aċidu glutamiku Fosfat di-idroġenu tal-potassju Fosfat tad-dipotassju Ilma għall-injezzjonijiet Klorur tas-sodju Fosfat anidru tad-dissodju
English: SUSPENSION VIAL
Maltese: KUNJETT TA' SUSPENSJONI
English: Cats
Maltese: IEĦOR
English: Suspension for LEUCOFELIGEN FeLV/RCP, for cats
Maltese: Suspensjoni għal LEUCOFELIGEN
English: The vaccine contains the purified p45 FeLV-envelope antigen, obtained by genetic recombination of the E. coli strain.
Maltese: Il-vaċċin fih l-antiġen envelopp p 45FeLV ippurifikat, miksub minn tlaqqiegħ ġenetiku tal-istrejn talE.coli.
English: SC
Maltese: CZ :
English: Disodium phosphate anhydrous
Maltese: 13. PREKAWZJONIJIET SPEĊJALI DWAR RIMI
English: In case of anaphylactic shock, appropriate symptomatic treatment should be administered.
Maltese: Fil-każ ta' xokk anafilattiku, għandha tingħata l-kura sintomatika addattata.
English: The feline calicivirus and feline panleucopenia virus vaccine strains can spread.
Maltese: L-istrejns tal-vaċċin tal-kaliċivirus felin u l-virus panlewkopenja felin jistgħu jinxterdu.
English: Visual aspect:
Maltese: SE:
English: 28065 Cerano (NO) Italy
Maltese: 28065 Cerano (NO) L-Italja
English: Hypromellose Macrogol 8000
Maltese: Macrogol 8000
English: County Wicklow Ireland
Maltese: County Wicklow L-Irlanda
English: Date of first authorisation: 11 December 2007 Date of latest renewal: 10 November 2017
Maltese: Data tal-ewwel awtorizzazzjoni: 11 ta' Diċembru 2007 Data tal-aħħar tiġdid: 10 ta' Novembru, 2017
English: Packs of 14, 28, 30, 50, 56, 60, 90, 98 and 180 tablets.
Maltese: Pakketti ta' 14, 28, 30, 50, 56, 60, 90, 98 u 180 pillola.
English: Absolute bioavailability is greater than 80%.
Maltese: Il-bijodisponibilità assoluta hija aktar minn 80%.
English: Sími: +354 535 7000 vistor@vistor.is
Maltese: +354 535 7000 vistor@vistor.is
English: The mean Vd ranged between 63-276 L.
Maltese: Il-medja ta' Vd varjat bejn 63-276 L.
English: Takeda Ireland Limited, Bray Business Park, Kilruddery, County Wicklow, Ireland Delpharm Novara S.r.l., Via Crosa, 86, I-28065 Cerano (NO), Italy Lilly S.A., Avda.
Maltese: Takeda Ireland Limited, Bray Business Park, Kilruddery, County Wicklow, L-Irlanda Delpharm Novara S.r.l, Via Crosa, 86, I-28065 Cerano (NO), L-Italja Lilly S.A., Avda. de la Industria 30, 28108 Alcobendas, Madrid, Spanja
English: GFR mL/min
Maltese: GFR mL/min Metformin
English: Adults with normal renal function (GFR ≥ 90 mL/min)
Maltese: Adulti b'funzjoni renali normali (GFR ≥ 90 mL/min)
English: EU/1/07/421/001 EU/1/07/421/002 EU/1/07/421/003 EU/1/07/421/004 EU/1/07/421/005 EU/1/07/421/006 EU/1/07/421/007 EU/1/07/421/008 EU/1/07/421/009
Maltese: EU/1/07/421/005 EU/1/07/421/006 EU/1/07/421/007 EU/1/07/421/008 EU/1/07/421/009
English: Three of the six identified metabolites are active (M-II, M-III, and M-IV).
Maltese: Tlieta mis-sitt metaboliti identifikati huma attivi (M-II, M-III, u M-IV).
English: Microcrystalline cellulose Povidone (K30) Croscarmellose sodium Magnesium stearate
Maltese: Qalba tal-pillola Mikrokristallina ċellulosi Povidone (K30) Croscarmellose sodium Magnesium stearate
English: EU/1/07/421/001 14 tablets EU/1/07/421/002 28 tablets EU/1/07/421/003 30 tablets EU/1/07/421/004 50 tablets EU/1/07/421/005 56 tablets EU/1/07/421/006 60 tablets EU/1/07/421/007 90 tablets EU/1/07/421/008 98 tablets EU/1/07/421/009 180 tablets
Maltese: EU/1/07/421/001 14-il pillola EU/1/07/421/002 28 pillola EU/1/07/421/003 30 pillola EU/1/07/421/004 50 pillola EU/1/07/421/005 56 pillola EU/1/07/421/006 60 pillola EU/1/07/421/007 90 pillola EU/1/07/421/008 98 pillola EU/1/07/421/009 180 pillola
English: Severe renal failure (GFR < 30 mL/min)
Maltese: - Insuffiċjenza renali severa (GFR <30 mL/min)
English: common common arthralgia common
Maltese: komuni komuni artralġja komuni
English: Immune System Disorders hypersensitivity and allergic reactions1
Maltese: Disturbi fis-sistema immuni sensittività eċċessiva u reazzjonijiet allerġiċi1
English: 180 tablets
Maltese: 180 pillola
English: This check should be repeated at intervals.
Maltese: Dan il-kontroll jista' jkun ripetut f'intervalli.
English: common common alanine aminotransferase increased9
Maltese: komuni komuni żieda fl-aminotrasferasi alanine 9
English: The other ingredients are microcrystalline cellulose, povidone (K30), croscarmellose sodium magnesium stearate, hypromellose, macrogol 8000, talc and titanium dioxide (E171).
Maltese: Is-sustanzi l-oħra huma mikrokristallina ċellulosi, povidone (K 30), croscarmellose sodium magnesium stearate, ipromellosi, macrogol 8000, talc u titanium dioxide (E171).
English: Takeda Pharma A/S Dybendal Alle 10 2630 Taastrup Denmark
Maltese: Takeda Pharma A/S Dybendal Alle 10 2630
English: Aluminium/aluminium blisters.
Maltese: Folji tal-aluminju/aluminju.
English: Metformin is contra-indicated
Maltese: Metformin huwa kontraindikat
English: a significant reduction of the absolute risk of any diabetes-related complication in the metformin group (29.8 events/1,000 patient-years) versus diet alone (43.3 events/1,000 patient-years), p=0.0023, and versus the combined sulphonylurea and insulin monotherapy groups (40.1 events/1,000 patient-years), p=0.0034 a significant reduction of the absolute risk of any diabetes-related mortality: metformin 7.5 events/1,000 patient-years, diet alone 12.7 events/1,000 patient-years, p=0.017 a significant reduction of the absolute risk of overall mortality: metformin 13.5 events/1,000 patient-years versus diet alone 20.6 events/1,000 patient-years, (p=0.011), and versus the combined sulphonylurea and insulin monotherapy groups 18.9 events/1,000 patient-years (p=0.021)
Maltese: tnaqqis sinifikanti tar-riskju assolut ta' kull kumplikazzjoni relatata ma' dijabete fil-grupp b'metformin (29.8 avveniment/1,000 pazjent-snin) kontra l-grupp b'dieta biss (43.3 avveniment/1,000 pazjent-snin), p=0.0023, u kontra l-gruppi ta' monoterapija b'sulphonylurea u b'insulina kombinati (40.1 avveniment/1,000 pazjent-snin), p=0.0034 tnaqqis sinifikanti fir-riskju assolut ta' kull mortalità relatata ma' dijabete: metformin 7.5 episodji/1,000 pazjent-snin, dieta biss 12.7 avvenimenti/1,000 pazjent-snin, p=0.017 tnaqqis sinifikanti fir-riskju assolut ta' mortalità globali: metformin 13.5 episodji/1,000 pazjentsnin kontra dieta biss 20.6 episodji/1,000 pazjent-snin, (p=0.011), u kontra l-gruppi ta' monoterapija b'sulphonylurea u b'insulina kombinati, 18.9 episodji/1,000 pazjent-snin (p=0.021) tnaqqis sinifikanti fir-riskju assolut ta' infart mijokardiku: metformin 11 episodji/1,000 pazjentsnin, dieta biss 18 avveniment/1,000 pazjent-snin, (p=0.01).
English: They are supplied in aluminium/aluminium blister in packs of 14, 28, 30, 50, 56, 60, 90, 98 or 180 tablets.
Maltese: Huma disponibbli f'pakketti bil-folji tal-aluminju/aluminju ta' 14, 28, 30, 50, 56, 60, 90, 98 jew 180 pillola.
English: Haematology
Maltese: Ematoloġija
English: Adverse reaction
Maltese: Reazzjonijiet avversi
English: Takeda Pharma AS Tel: +372 6177 669 info@takeda.ee
Maltese: Takeda Pharma AS Tel: +372 6177 669 info@nycomed.ee
English: Polycystic ovarian syndrome
Maltese: Sindromu tal-ovarji poliċistiċi
English: Steady state pharmacokinetics are similar in patients age 65 and over and young subjects.
Maltese: Il-farmakokinetika fi stat fiss ta' pazjenti b'età ta' 65 sena jew aktar hija simili għal dik ta' pazjenti żgħar.
English: very rare very rare lactic acidosis very rare very rare
Maltese: rari ħafna rari ħafna aċidożi lattika rari ħafna rari ħafna
English: The fixed dose combination tablet of pioglitazone 15 mg/metformin 850 mg BID (N=201), pioglitazone 15 mg BID (N=189), and metformin 850 mg BID (N=210) were evaluated in type 2 diabetes mellitus patients with mean baseline HbA1c of 9.5% in a randomised double-blind, parallel-group study.
Maltese: Il-pillola b'doża kombinata fissa ta' pioglitazone 15 mg/metformin 850 mg BID (N=201), pioglitazone 15 mg BID (N=189), u metformin 850 mg BID (N=210) kienu evalwati fi studju każwali doppju agħmi, u b'grupp parallelu, f'pazjenti b'dijabete mellitus tat-tip 2 b'medja ta' HbA1c fil-linja bażi ta'
English: The clinical relevance of this decrease is unknown.
Maltese: Ir-rilevanza klinika ta' dan it-tnaqqis mhix magħrufa.
English: Tmax was delayed by food by approximately 1.9 h for pioglitazone and 0.8 h for metformin.
Maltese: Tmax kien ittardjat bl-ikel b'madwar 1.9 h għal pioglitazone u 0.8 h għal metfomin.
English: Delpharm Novara S.r.l.
Maltese: Delpharm Novara S.r.l Via Crosa, 86
English: Marketing authorisation holder: Takeda Pharma A/S, Dybendal Alle 10, 2630 Taastrup,
Maltese: Takeda Pharma A/S, Dybendal Alle 10, 2630