FrancophonIA/ELRC3.0 huggingface dataset:
English: The first study involved 22 patients aged 12 years and above, who were given Vihuma for the treatment of bleeding episodes or to prevent bleeding during surgery.
Maltese: L-ewwel studju involva 22 pazjent minn 12-il sena 'l fuq, li ngħataw Vihuma għall-kura ta'episodji ta' emorraġija jew għall-prevenzjoni ta' emorraġija waqt il-kirurġija.
English: In the 5 surgeries during the study, Vihuma was rated excellent in preventing bleeding episodes for 4 surgeries and as moderate to prevent bleeding during one surgical intervention.
Maltese: Fil-ħames kirurġiji matul l-istudju, Vihuma ġie kklassifikat bħala eċċellenti fil-prevenzjoni ta' episodji ta' emorraġija għal erba' kirurġiji u bħala moderat fil-prevenzjoni ta' emorraġija waqt intervent kirurġiku wieħed.
English: As for all medicines, data on the use of Vihuma are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Vihuma hija ssorveljata kontinwament.
English: The active substance in Vihuma, simoctocog alfa (human coagulation factor VIII), is a substance that helps the blood to clot.
Maltese: Is-sustanza attiva f'Vihuma, is-simoctocog alfa, (fattur tal-koagulazzjoni VIII tal-bniedem), hija sustanza li tgħin lid-demm jagħqad.
English: This medicine is the same as Nuwiq, which is already authorised in the EU.
Maltese: Din il-mediċina hija l-istess bħal Nuwiq, li diġà hija awtorizzata fl-UE.
English: When Vihuma was used to prevent bleeding, an average of 0.34 bleeding episode per month was recorded for each child.
Maltese: Meta Vihuma ntuża biex jipprevjeni emorraġija, ġiet irreġistrata medja ta' 0.34 episodju ta' emorraġija kull xahar għal kull wild.
English: When used for treating bleeding episodes, Vihuma was mainly rated ‘excellent' or ‘good' at treating major bleeding episodes and most bleeding episodes resolved following one or more injections of Vihuma.
Maltese: Meta ntuża għall-kura ta' episodji ta' emorraġija, Vihuma ġie primarjament ikklassifikat bħala “eċċellenti” jew “tajjeb” fil-kura ta' episodji ta' emorraġija maġġuri u l-parti l-kbira tal-episodji ta' emorraġija ssolvew wara injezzjoni waħda jew iktar ta' Vihuma.
English: How does Vihuma work?
Maltese: Kif jintuża Vihuma?
English: Vihuma is a medicine used for the treatment and prevention of bleeding in patients of all ages with haemophilia A (an inherited bleeding disorder caused by lack of factor VIII).
Maltese: Vihuma huwa mediċina li tintuża għall-kura u l-prevenzjoni ta' emorraġija f'pazjenti ta' kull età b'emofilja A (disturb ta' emorraġija li jintiret ikkawżat minn nuqqas tal-fattur VIII).
English: The dose and duration of treatment depend on whether Vihuma is used to treat or prevent bleeding, or during surgery, as well as on the patient's factor VIII levels, the seriousness of the haemophilia, the extent and location of the bleeding and the patient's condition and weight.
Maltese: Iddoża u l-frekwenza tal-kura jiddependu fuq jekk Vihuma jintużax għall-kura jew għall-prevenzjoni ta' emorraġija, jew matul kirurġija, kif ukoll fuq il-livelli tal-fattur VIII tal-pazjent, is-severità tal-emofilja, il-firxa u l-post tal-emorraġija u l-kundizzjoni u l-piż tal-ġisem tal-pazjent.
English: For the full list of side effects and restrictions of Vihuma, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet ta' Vihuma, ara l-fuljett ta' tagħrif.
English: What measures are being taken to ensure the safe and effective use of Vihuma?
Maltese: X'miżuri qegħdin jitteħdu biex jiġi żgurat l-użu sigur u effettiv ta' Vihuma?
English: 1 Antigenic mass ELISA units.
Maltese: Unitajiet ta' antigenic mass ELISA .
English: 10 ml (10 doses)
Maltese: 10ml (10 dożi)
English: MARKETING AUTHORISATION NUMBER(S) EU/2/15/183/001 - 10 vials (1 ml) EU/2/15/183/002 - 50 vials (1 ml) EU/2/15/183/003 - 1 vial (10 ml)
Maltese: TAL-AWTORIZZAZZJONI TAL-KUMMERĊ EU/2/15/183/001 - 10 vials (1 ml) EU/2/15/183/002 - 50 vials (1 ml) EU/2/15/183/003 - 1 vial (10 ml)
English: 10x 1 ml (1 dose) 50x 1 ml (1 dose) 1x 10 ml (10 doses)
Maltese: 10 x 1 ml (doża1) 50 x 1ml (doża1) 1 x 10ml (10 dożi)
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 03/07/2015
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI / TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 03/07/2015
English: 0.1 mg Colourless suspension.
Maltese: 0.1mg Suspensjoni bla kulur.
English: België/Belgique/Belgien: VIRBAC,
Maltese: België/Belgique/Belgien:
English: - L. interrogans serogroup Icterohaemorrhagiae serovar Copenhageni (strain Ic-02-001)
Maltese: - L. interrogans serogrupp Icterohaemorrhagiae serovar Copenhageni (strejn Ic-02-001)
English: Bury St. Edmunds, Suffolk, IP30 9UP, Tel: + 44 (0) 1359 243243
Maltese: Edmunds, Suffolk, IP30 9UP, Tel: + 44 (0) 1359 243243
English: Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands
Maltese: Wim de Körverstraat 35 5831 AN Boxmeer In-Netherlands
English: VIRBAC France, 13ème rue - L.I.D., FR-06517 Carros, service-conso@virbac.fr
Maltese: ème rue - L.I.D., FR-06517 Carros, service-conso@virbac.fr
English: Luxembourg/Luxemburg: VIRBAC,
Maltese: Luxembourg/Luxemburg:
English: FR-06516 Carros, France,
Maltese: FR-06516 Carros, Frankreich,
English: - L. kirschneri serogroup Grippotyphosa serovar Dadas (strain Gr-01-005)
Maltese: - L. kirschneri serogrupp Grippotyphosa serovar Dadas
English: Potassium chloride Disodium phosphate dihydrate Potassium dihydrogen phosphate Water for injections
Maltese: Klorur tas-sodju Klorur tal-potassju Deidrat tal-fosfat tad-disodju Fosfat deidronizzat tal-potassju Ilma għall-injezzjoni
English: - L. interrogans serogroup Australis serovar Bratislava (strain As-05-073)
Maltese: - L. interrogans serogroup Australis serovar Bratislava
English: Duration of immunity: 1 year.
Maltese: L-immunità ddum sa: 1 sena.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/15/183/001-003
Maltese: TAL-AWTORIZZAZZJONI TAL-KUMMERĊ EU/2/15/183/001-003
English: (just for 10 ml vials)
Maltese: (għall-kunjetti ta' 10 ml biss)
English: 1 ml and 10 ml vial
Maltese: Kunjetti 1ml u 10ml
English: 0.1 mg For the full list of excipients, see section 6.1.
Maltese: 0.1mg Għal-lista sħiħa tal-ingredjenti (mhux attivi), ara s-sezzjoni 6.1.
English: Onset of immunity: 3 weeks.
Maltese: L-immunità tibda minn: 3 ġimgħat.
English: Inactivated Leptospira strains: - L. interrogans serogroup Canicola serovar Portland-vere (strain Ca-12
Maltese: Strejns ta' Leptospira inattivati: - L. interrogans serogrupp Canicola serovar Portland-vere
English: Active substances:
Maltese: Manifattur tas-sustanza attiva
English: Basic vaccination: The first vaccination can be administered from 6 to 9(*) weeks of age and the second vaccination from 10 to 13 weeks of age.
Maltese: L-ewwel vaċċinazzjoni tista' tiġi amministrata mill-età ta' 6 sa 9(*) ġimgħat u t-tieni vaċċinazzjoni mill-età ta' 10 sa 13-il ġimgħa.
English: Type I glass vial of 1 ml (1 dose) or 10 ml (10 doses) closed with a halogenobutyl rubber stopper and sealed with a coded aluminium cap.
Maltese: Kunjett tal-ħġieġ tip I ta' 1ml (doża 1) jew 10ml (10 dożi) magħluq b'tapp tal-gomma halogenbutyl u ssiġillat b'kappa tal-aluminjum kodifikat.
English: Pharmacotherapeutic group: Immunologicals for Canidae, inactivated bacterial vaccine.
Maltese: Immunoloġiku għall-klieb, vaċċin batteriku inattivat.
English: Γαλλία,
Maltese: KONTENUT BĦALA
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Canigen L4 suspension for injection for dogs
Maltese: VETERINARJU Canigen L4 suspensjoni għal injezzjoni għall-klieb
English: FR-06516 Carros,
Maltese: FR-06516 Carros, Γαλλία,
English: ATCvet code QI07AB01.
Maltese: Kodiċi veterinarja ATC QI07B01
English: Do not mix with any other veterinary medicinal products except those mentioned in section 4.8.
Maltese: Tħallatx ma' tilqim jew prodotti veterinarji mediċinali oħra apparti dawk imsemmija f'sezzjoni 4.8
English: The mixed vaccines should be at room temperature (15°C - 25°C) before they are administered by subcutaneous injection.
Maltese: Il-vaċċini mħaltin għandhom ikunu f'temperatura tal-kamra (15°C - 25°C) qabel ma jiġu amministrati taħt il-ġilda.
English: Cardboard box with 1 vial of 10 ml (10 doses).
Maltese: Kaxxa tal-kartun b'kunjett 1 ta' 10ml (10 dożi).
English: Plastic box with 10, or 50 vials of 1 ml Cardboard box with 1 vial of 10 ml
Maltese: Kaxxa tal-plastik b' 10 jew 50 kunjett ta' 1ml Kaxxa tal-kartun b' kunjett 1 ta' 10 ml
English: When mixed with Canigen vaccines containing canine parainfluenza virus strain Cornell at annual revaccination, it has been established that there is no interference with the anamnestic response induced by the injectable canine parainfluenza virus component.
Maltese: Meta mħallat mal-vaċċini Canigen li fihom il-parainfluenza virus tal-klieb strejn Cornell waqt ir-rivaċċinazzjoni annwali, ġie stabbilit li m`hemmx interferenza mar-rispons immunoloġiku indott mill-komponent injettabbli talparainfluenza virus tal-klieb.
English: For simultaneous use with Canigen vaccines where authorised: 1 dose of a Canigen vaccine from the same marketing authorisation holder (or national subsidiary) containing canine distemper virus strain Onderstepoort, canine adenovirus type 2 strain Manhattan LPV3, canine parvovirus strain 154, and/or canine parainfluenza virus strain Cornell components should be reconstituted with 1 dose (1 ml) of Canigen L4.
Maltese: Għall-użu flimkien ma' vaċċini Canigen fejn awtorizzati (jew sussidjarju nazzjonali) li fih distemper virus tal-klieb strejn Onderstepoort, adenovirus tal-klieb tip 2 strejn Manhattan LPV3, komponenti tal- parvovirus tal-klieb strejn 154 u/jew komponenti tal-parainfluenza tal-klieb strejn Cornell għandhom jiġu rikostitwiti ma' doża (1ml) ta' Canigen L4.
English: PACKAGE LEAFLET: Canigen L4 suspension for injection for dogs
Maltese: FIL-PAKKETT Canigen L4 suspensjoni għal injezzjoni għall-klieb
English: Plastic box with 10 or 50 vials of 1 ml (1 dose).
Maltese: Kaxxa tal-plastik b'10 jew 50 kunjett ta' 1ml (doża1).
English: FR-06516 Carros, France/ Frankrijk/Frankreich Tel: + 33 (0) 4 92 08 73 00
Maltese: 1ère avenue 2065 m - L.I.D., FR-06516 Carros, France/ Frankrijk/Frankreich Tel: + 33 (0) 4 92 08 73 00
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Canigen L4
Maltese: Canigen L4
English: Safety and efficacy data are available which demonstrate that this vaccine can be mixed and administered with vaccines of the Canigen series from the same marketing authorisation holder (or national subsidiary) containing canine distemper virus strain Onderstepoort, canine adenovirus type 2 strain Manhattan LPV3, canine parvovirus strain 154 and/or canine parainfluenza virus strain Cornell components for subcutaneous administration where authorised.
Maltese: Data fuq is-sigurtà u l-effikaċja huma disponibbli li juru li dan il-vaċċin jista' jitħallat u amministrat ma' vaċċini tas-serje Canigen mill-istess sid tal-awtorizzazzjoni (jew sussidjarju nazzjonali) li fihom distemper virus tal-klieb strejn Onderstepoort, adenovirus tal-klieb tip 2 strejn Manhattan LPV3, parvovirus tal-klieb strejn 154 u/jew komponenti tal-parainfluenza virus strejn Cornell għall-injezzjoni taħt il-ġilda fejn awtorizzati.
English: Shelf life after first opening the immediate container: 10 hours.
Maltese: Żmien li l-prodott jibqa' tajjeb wara li jkun infetaħ il-kontenitur ewlieni: 10 sigħat.
English: Safety and efficacy data are available which demonstrate that this vaccine can be administered on the same day but not mixed with vaccines of the Canigen series from the same marketing authorisation holder (or national subsidiary) containing Bordetella bronchiseptica strain B-C2 and/or canine parainfluenza virus strain Cornell components for intranasal administration where authorised.
Maltese: Data fuq is-sigurtà u l-effikaċja huma disponibbli li juru li dan il-vaċċin jista' jingħata fl-istess ġurnata iżda mhux imħallat ma' vaċċini tas-serje Canigen mill-istess sid tal-awtorizzazzjoni (jew sussidjarju nazzjonali) li fihom komponenti tal-Bordetella bronchiseptica strejn B-C2 u/jew parainfluenza virus tal-klieb strejn Cornell għall-amministrazzjoni fl-imnieħer fejn awtorizzat.
English: DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
Maltese: DATA TA' META ĠIET RIVEDUTA DIN IL-KITBA Informazzjoni dettaljata dwar dan il-prodott mediċinali veterinarju tinstab fuq il-websajt tal-Aġenzija Ewropea dwar il-Mediċini http://www.ema.europa.eu/.
English: Sodium chloride
Maltese: DIKJARAZZJONI TAL-MRLs
English: Administer two vaccinations of 1 dose (1 ml) of vaccine with an interval of 4 weeks to dogs from 6 weeks of age onwards.
Maltese: Amministra żewġ vaċċinazzjonijiet ta' doża (1ml) tal-vaċċin b'intervall ta' 4 ġimgħat lill-klieb mill-età ta' 6 ġimgħat 'il quddiem.
English: To be supplied only on veterinary prescription.
Maltese: Sabiex jiġi mgħoti biss bi preskrizzjoni veterinarja.
English: Further information on Benlysta can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/benlysta.
Maltese: ema.europa.eu/medicines/human/EPAR/benlysta.
English: Benlysta contains the active substance belimumab.
Maltese: Benlysta fih is-sustanza attiva belimumab.
English: Other information about Benlysta
Maltese: Informazzjoni oħra dwar Benlysta
English: In the second study, disease activity decreased in 58% of patients treated with Benlysta, compared with 44% of patients who were given placebo.
Maltese: Fit-tieni studju, l-attività talmarda naqset fi 58 % tal-pazjenti kkurati b'Benlysta, meta mqabbel ma' 44 % tal-pazjenti li ngħataw il-plaċebo.
English: The active substance in Benlysta, belimumab, is a monoclonal antibody, a protein that has been designed to attach to and block a protein called BLyS which helps B lymphocytes to live longer.
Maltese: Is-sustanza attiva f'Benlysta, il-belimumab, hija antikorp monoklonali, proteina li tfasslet biex teħel ma' u timblokka proteina msejħa BLyS li tgħin lil-limfoċiti B jgħixu aktar fit-tul.
English: Infections may be more likely in younger children.
Maltese: Il-probabbiltà hi li linfezzjonijiet jistgħu joħorġu aktar fi tfal iżgħar.
English: Benlysta is available as a powder (120 mg and 400 mg) that is made up into a solution for infusion (drip) into a vein; it is also available as a pre-filled pen and pre-filled syringe (200 mg) for injection under the skin.
Maltese: Benlysta jiġi bħala trab (120 mg u 400 mg) li jsir f'soluzzjoni għall-infużjoni (dripp) ġol-vina; jiġi wkoll bħala pinna mimlija lesta u siringa mimlija lesta (200 mg) għal injezzjoni taħt il-ġilda.
English: Benlysta is a medicine used as an add-on treatment in patients aged 5 years and older with systemic lupus erythematosus (SLE), a disease in which the immune system (the body's natural defences) attacks normal cells and tissues, causing inflammation and organ damage.
Maltese: Benlysta huwa mediċina li tintuża bħala kura addizzjonali f'pazjenti minn 5 snin 'il fuq b'lupus erythematosus sistemiku (SLE, systemic lupus erythematosus), marda li fiha s-sistema immunitarja (id-difiżi naturali tal-ġisem) tattakka ċ-ċelloli u t-tessuti normali, u b'hekk tikkawża infjammazzjoni u ħsara fl-organi.
English: The Agency also noted the lack of effective alternative treatments for patients who have already tried standard treatments.
Maltese: L-Aġenzija nnutat ukoll in-nuqqas ta' kuri alternattivi effettivi għal pazjenti li diġà jkunu ppruvaw kuri standard.
English: Another study involved 836 adult patients with active SLE, who received add-on Benlysta as an injection under the skin once a week for a year.
Maltese: Studju ieħor involva 836 pazjent adult b'SLE attiva, li rċevew Benlysta bħala żieda bħala injezzjoni taħt il-ġilda darba fil-ġimgħa għal sena.
English: Results from a main study involving 93 children aged 5 to 17 years with active SLE showed that Benlysta was distributed in the body in a similar way as in adults and could be expected to have similar benefits.
Maltese: Riżultati minn studju ewlieni li involva 93 tifel u tifla li kellhom bejn il-ħames snin u s-17-il sena b'SLE attiva wera li Benlysta tqassam fil-ġisem b'mod simili fl-adulti u jista' jkun mistenni li jkollu benefiċċji simili.
English: The study showed that disease activity decreased in 61% of patients treated with Benlysta, compared with 48% of patients given placebo.
Maltese: L-istudju wera li l-attività tal-marda naqset f'61 % tal-pazjenti kkurati b'Benlysta, meta mqabbel ma' 48 % tal-pazjenti li ngħataw il-plaċebo.
English: As for all medicines, data on the use of Benlysta are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Benlysta hija ssorveljata kontinwament.
English: Official address Domenico Scarlattilaan 6 ● 1083 HS Amsterdam ● The Netherlands
Maltese: Ħarsa ġenerali lejn Benlysta u għalfejn huwa awtorizzat fl-UE
English: In the first study, disease activity decreased in 43% of patients treated with Benlysta, compared with 34% of patients who were given placebo.
Maltese: Fl-ewwel studju, l-attività tal-marda naqset fi 43 % tal-pazjenti kkurati b'Benlysta, meta mqabbel ma' 34 % tal-pazjenti li ngħataw il-plaċebo.
English: The most common side effects with Benlysta (which may affect more than 1 in 10 people) are bacterial infections, such as bronchitis (infection in the lungs) and infection of the urinary tract (structures that produce or carry urine), diarrhoea and nausea (feeling sick).
Maltese: L-effetti sekondarji l-aktar komuni b'Benlysta (li jistgħu jaffettwaw aktar minn persuna 1 minn kull 10) huma infezzjonijiet batteriċi, bħal bronkite (infezzjoni fil-pulmun) u infezzjoni fl-apparat tal-awrina (strutturi li jipproduċu jew iġorru l-awrina), dijarea u nawżja (tħossok ma tiflaħx).
English: What are the risks associated with Benlysta?
Maltese: X'inhuma r-riskji assoċjati ma' Benlysta?
English: Usually, B lymphocytes produce antibodies which help to fight infections.
Maltese: Normalment, il-limfoċiti B jipproduċu antikorpi li jgħinu fil-ġlieda kontra linfezzjonijiet.
English: What measures are being taken to ensure the safe and effective use of Benlysta?
Maltese: X'miżuri qed jittieħdu biex jiġi żgurat l-użu sigur u effettiv ta' Benlysta?
English: In adults, Benlysta can also be given as a 200-mg injection under the skin, once a week.
Maltese: Fl-adulti, Benlysta jista' jingħata wkoll bħala injezzjoni ta' 200 mg taħt il-ġilda, darba fil-ġimgħa.
English: Benlysta given by infusion was shown to be more effective than placebo (a dummy treatment) in reducing disease activity when used as an add-on treatment for SLE in two main studies involving 1,693 adult patients with active SLE.
Maltese: F'żewġ studji ewlenin li involvew 1,693 pazjent adult b'SLE attiva, Benlysta mogħti b'infużjoni ntwera li kien aktar effettiv mill-plaċebo (kura finta) biex inaqqas l-attività tal-marda meta ntuża bħala kura ta' żieda għal SLE attiva.
English: By blocking the action of BLyS, belimumab reduces the life span of B lymphocytes, thereby reducing the inflammation and organ damage that occur in SLE.
Maltese: Billi timblokka l-azzjoni ta' BLyS, il-belimumab tnaqqas it-tul tal-ħajja tal-limfoċiti B, b'hekk tnaqqas l-infjammazjoni u l-ħsara fl-organi li jseħħu fl-SLE.
English: For the full list of side effects and restrictions of Benlysta, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet ta' Benlysta, ara l-fuljett ta' tagħrif.
English: Benlysta is given to patients whose disease is still highly active despite standard treatment.
Maltese: Benlysta jingħata lil pazjenti li l-marda tagħhom tkun għadha attiva ħafna minkejja kura standard.
English: The medicine may cause infusion and hypersensitivity reactions as well as infections, but is generally well tolerated.
Maltese: Il-mediċina tista' tikkawża reazzjonijiet ta' infużjoni u ta' ipersensittività kif ukoll infezzjonijiet, iżda ġeneralment hija ttollerata sewwa.
English: The doctor may interrupt or stop treatment if the patient develops reactions linked to the infusion (such as rash, itchiness and difficulty breathing) or hypersensitivity (allergic) reactions which may be severe and life-threatening and can develop several hours after Benlysta is given.
Maltese: It-tabib jista' jinterrompi jew iwaqqaf il-kura jekk il-pazjent jiżviluppa reazzjonijiet marbutin malinfużjoni (bħal raxx, ħakk u diffikultà fit-teħid tan-nifs) jew reazzjonijiet ta' ipersensittività (allerġiji) li jistgħu jkunu gravi u ta' periklu għall-ħajja u li jistgħu jiżviluppaw diversi sigħat wara li jingħata Benlysta.
English: Side effects reported with Benlysta are carefully evaluated and any necessary action taken to protect patients.
Maltese: L-effetti sekondarji rrappurtati b'Benlysta huma evalwati bir-reqqa u kull azzjoni meħtieġa hi meħuda biex tipproteġi lill-pazjenti.
English: How is Benlysta used?
Maltese: Kif jaħdem Benlysta?
English: Ref. EMEA/CHMP/744722/2009 rev. EMEA/H/A-29/1170
Maltese: EMEA/CHMP/744722/2009 rev.
English: Questions and answers on the referral for Pantoprazole Olinka pantoprazole 20 and 40 mg tablets
Maltese: Mistoqsijiet u tweġibiet dwar ir-referenza għal Pantoprazole Olinka pantoprazole 20 u 40 mg pilloli
English: What is Pantoprazole Olinka?
Maltese: X'inhi Pantoprazole Olinka?
English: The active substance in Pantoprazole Olinka, pantoprazole, is a proton pump inhibitor.
Maltese: Is-sustanza attiva f'Pantoprazole Olinka, pantoprazole, hija inibitur tal-pompa tal-protoni.
English: Pantoprozole Olinka is a generic medicine based on the reference medicine Pantecta.
Maltese: Pantoprozole Olinka hija mediċina ġenerika bbażata fuq il-mediċina ta' referenza Pantecta.
English: Olinka UK Ltd. submitted Pantoprazole Olinka to the United Kingdom medicines regulatory agency for a decentralised procedure.
Maltese: Olinka UK Ltd. issottomettiet Pantoprazole Olinka lill-aġenzija regolatorja tal-mediċini tar-Renju Unit għal proċedura deċentralizzata.
English: The 20 mg tablets can be used for reflux disease to treat symptoms such as heartburns and acid regurgitation (acid flowing up in the mouth), for the long-term management and prevention of relapse in reflux oesophagitis (inflammation of the gullet, due to acid), for the prevention of the stomach ulcers that can be caused by some medicines used to treat pain and inflammations called non-selective non-steroidal anti-inflammatory drugs (NSAIDs), when the patient needs continuous NSAID treatment.
Maltese: Il-pilloli ta' 20 mg jistgħu jintużaw għall-mard ta' rifluss biex jikkuraw sintomi bħal ħruq ta' stonku u regurgitazzjoni tal-aċidu (aċidu li jitla' għall-ħalq), għall-ġestjoni fit-tul u l-prevenzjoni ta' rikaduta ta' esofaġite ta' rifluss (infjammazzjoni tal-esofagu, minħabba l-aċidu), għall-prevenzjoni tal-ulċeri flistonku li jistgħu jiġu kkawżati minn xi mediċini użati għall-kura ta' uġigħ u infjammazzjonijiet imsejħin mediċini kontra l-infjammazzjoni mhux sterojdali mhux selettivi (NSAIDs), meta l-pazjent ikun jeħtieġ kura kontinwa b'NSAIDs.
English: Why was Pantoprazole Olinka reviewed?
Maltese: Għaliex ġiet riveduta Pantoprazole Olinka?
English: Pantoprazole Olinka is presented as gastro-resistant tablets.
Maltese: Pantoprazole Olinka tiġi bħala pilloli gastro-reżistenti.
English: However, the member states were not able to reach an agreement and the UK medicines regulatory agency referred the matter to the CHMP for arbitration on 30 April 2009.
Maltese: Madankollu, l-Istati Membri ma setgħux jaslu għal ftehim u l-aġenzija regolatorja tal-mediċini tarRenju Unit, irreferiet il-kwistjoni lis-CHMP għal arbitraġġ fit-30 ta' April 2009.
English: The European Medicines Agency (EMEA) has completed an arbitration procedure following a disagreement among Member States of the European Union regarding the authorisation of the medicine Pantoprazole Olinka.
Maltese: L-Aġenzija Ewropea tal-Mediċini (EMEA) temmet proċedura ta' arbitraġġ wara nuqqas ta' qbil fost lIstati Membri tal-Unjoni Ewropea dwar l-awtorizzazzjoni għat-tqegħid fis-suq tal-mediċina Pantoprazole Olinka.