FrancophonIA/ELRC3.0 huggingface dataset:
English: Hypersensitivity (allergic) reactions are uncommon with Adynovi (affecting up to 1 in 100 people) and may include swelling, burning and stinging at the injection site, chills, flushing, itchy rash, headache, hives, low blood pressure, lethargy, nausea and vomiting, restlessness, a rapid heartbeat, tightness of the chest and wheezing.
Maltese: Reazzjonijiet ta' sensittività eċċessiva (allerġiċi) mhumiex komuni b'Adynovi (li jaffettwaw sa 1 minn kull 100) u jistgħu jinkludu: nefħa, ħruq u tingiż fis-sit tal-injezzjoni, dehxiet ta' bard, fwawar, raxx bilħakk, uġigħ ta' ras, urtikarja, pressjoni tad-demm baxxa, letarġija, dardir u rimettar, nuqqas ta' sabar, taħbita mgħaġġla tal-qalb, tagħfis fis-sider u tħarħir.
English: Other information about Adynovi
Maltese: Informazzjoni oħra dwar Adynovi
English: Adynovi contains the active substance rurioctocog alfa pegol.
Maltese: Adynovi fih is-sustanza attiva rurioctocog alfa pegol.
English: Why is Adynovi approved?
Maltese: Għaliex ġiet approvat Adynovi?
English: This is a summary of the European public assessment report (EPAR) for Adynovi.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Adynovi.
English: In a study involving 138 adults and adolescents aged 12 years or above, 120 patients given Adynovi as a twice-weekly preventive treatment had, on average, around 4 bleeding episodes a year, and 17 patients given Adynovi for treating bleedings ‘on demand' had around 43 bleeding episodes a year.
Maltese: Fi studju li fih ħadu sehem 138 adult u adolexxent ta' 12-il sena jew akbar, 120 pazjent li ngħataw Adynovi bħala kura preventiva darbtejn fil-ġimgħa kellhom, bħala medja, madwar 4 episodji ta' fsada fis-sena, u 17-il pazjent li ngħataw Adynovi għall-kura ta' fsada "fuq talba" kellhom madwar 43 episodju ta' fsada fis-sena.
English: Around 83% of bleeding episodes resolved with one injection.
Maltese: Madwar 83 % tal-episodji ta' fsada kienu solvuti b'injezzjoni waħda.
English: The company that markets Adynovi will conduct a study to investigate the potential effects of PEG accumulation in the choroid plexus of the brain and other organs.
Maltese: Il-kumpanija li tqiegħed Adynovi fis-suq se twettaq studju biex jiġu investigati l-effetti potenzjali talakkumulazzjoni ta' PEG fil-choroid plexus tal-moħħ u f'organi oħra.
English: What are the risks associated with Adynovi?
Maltese: X'inhuma r-riskji assoċjati ma' Adynovi?
English: Around 96% of bleeding episodes resolved with one or two injections of Adynovi.
Maltese: Madwar 96 % tal-episodji ta' fsada kienu riżolti b'injezzjoni waħda jew b'żewġ injezzjonijiet ta' Adynovi.
English: Adynovi has been shown in two main studies to be effective at preventing and treating bleeding episodes in patients with severe haemophilia who were previously treated with other factor VIII products.
Maltese: Adynovi f'żewġ studji ewlenin intwera li huwa effettiv fil-prevenzjoni u fil-kura ta' episodji ta' fsada f'pazjenti b'emofija severa li qabel ġew ikkurati bi prodotti oħra tal-fattur VIII.
English: The active substance in Adynovi, rurioctocog alfa pegol, works in the body in the same way as human factor VIII.
Maltese: Is-sustanza attiva f'Adynovi, rurioctocog alfa pegol, taħdem fil-ġisem bl-istess mod bħall-fattur VIII uman.
English: Adynovi must not be used in patients who are hypersensitive (allergic) to rurioctocog alfa pegol or the related substance octocog alfa or to any of the other ingredients of the medicine, nor in those with known allergy to mouse or hamster proteins.
Maltese: Adynovi m'għandux jintuża f'pazjenti b'sensittività eċċessiva (allerġiċi) għal rurioctocog alfa pegol jew is-sustanza relatata octocog alfa jew għal kwalunkwe ingredjent ieħor tal-mediċina, u lanqas f'pazjenti b'allerġija magħrufa għall-proteini tal-ġrieden jew tal-ħemsters.
English: During this period, around 38% of patients (25 out of 66) had no bleeding episodes, and none of the patients developed antibodies against Adynovi, which can cause the medicine to stop working.
Maltese: Matul dan il-perjodu, madwar 38 % tal-pazjenti (25 minn 66) ma kellhom l-ebda episodju ta' fsada, u ħadd mill-pazjenti ma żviluppa antikorpi kontra Adynovi, li jista' jikkawża l-mediċina li tieqaf tkun effikaċi.
English: However, part of the active substance in Adynovi (called PEG) may accumulate in the body, including in a structure in the brain called the choroid plexus, following long-term treatment.
Maltese: Madankollu, parti mis-sustanza attiva f'Adynovi (imsejħa PEG) tista' takkumula fil-ġisem, inkluż fi struttura fil-moħħ imsejħa l-choroid plexus, wara kura fit-tul.
English: Adynovi is available as a powder and solvent that are mixed together to make a solution for injection into a vein.
Maltese: Adynovi jiġi bħala trab u solvent li jitħalltu flimkien biex jagħmlu soluzzjoni għal injezzjoni ġol-vina.
English: Since this could potentially cause problems especially in children below 12 years of age, Adynovi is only approved for use in adults and children from 12 years of age.
Maltese: Minħabba li dan potenzjalment jista' jikkawża problemi speċjalment fi tfal taħt it-12-il sena, Adynovi huwa approvat biss għall-użu fl-adulti u fi tfal ta' aktar minn 12-il sena.
English: Following treatment with factor VIII products, including Adynovi, some patients may develop inhibitors (antibodies) against factor VIII, causing the medicine to stop working and resulting in a loss of bleeding control.
Maltese: Wara kura bi prodotti tal-fattur VIII, inkluż Adynovi, ċerti pazjenti jistgħu jiżviluppaw inibituri (antikorpi) kontra l-fattur VIII, li jikkawżaw lill-mediċina li tieqaf tkun effikaċi u dan jirriżulta f'telf talkontroll tal-emorraġija.
English: What measures are being taken to ensure the safe and effective use of Adynovi?
Maltese: X'miżuri qegħdin jittieħdu biex jiġi żgurat l-użu sigur u effettiv ta' Adynovi?
English: What benefits of Adynovi have been shown in studies?
Maltese: X'inhuma l-benefiċċji ta' Adynovi li ħarġu mill-istudji?
English: ATCvet code: QA08AB91
Maltese: QA08AB91.
English: Slovenská republika Zoetis Luxembourg Holding Sarl, o.z.
Maltese: Република България Zoetis Luxembourg Holding Sarl Teл:
English: Dirlotapide is a potent selective inhibitor of the Microsomal Triglyceride transfer Protein (MTP).
Maltese: Dirlotapide hu inibitur selettiv potenti tal-proteini tal-Microsomal Triglyceride Transfer (MTP).
English: 4.10 Overdose (symptoms, emergency procedures, antidotes)
Maltese: 4.10 Doża eċċessiva (sintomi, proċeduri ta' emerġenza, antidoti), jekk ikun hemm bżonn
English: In a 14-day repeated dose study, AUC increased 3-fold from Day 1to Day 14.
Maltese: Fi studju ta' 14-il ġurnata ta' doża ripetuta, l-AUC żdied b' 3 darbiet minn Jum 1 sa Jum 14.
English: For the full list of excipients, see section 6.1.
Maltese: Għall-lista sħiħa ta' l-ingredjenti (mhux attivi), ara sezzjoni 6.1.
English: NATURE: 20 ml, 50 ml, 150 ml bottle
Maltese: Fliexken ta' 20 ml, 50 ml, 150 ml
English: There is no gender effect on pharmacokinetic parameters.
Maltese: M'hemm lebda effett ta' sess fuq il-parametri farmakokinetiċi.
English: Advice for Veterinarian
Maltese: Parir lill-Veterinarju
English: MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Maltese: MANIFATTUR TAS-SUSTANZA BIOLOĠIKA ATTIVA U MANIFATTUR RESPONSABBLI
English: Not applicable (systematic) Dose 2 = Dose 1 x 2
Maltese: Ma japplikax (Sistematiku) Doża 2 = Doża 1 x 2
English: Dirlotapide exhibited rapid oral absorption with mean Cmax values in the range of 8.5- 115 ng/ml, at 0.5 to 4 hours post-treatment (mean Tmax: 1.0 to 2.1 hours).
Maltese: Dirlotapide wera assorbiment orali ta' malajr bil-valuri medji Cmax bejn 8.5- 115 ng/ml, minn nofs siegħa sa 4 sigħat wara t-trattament (medja Tmax: minn 1.0 sa 2.1 siegħat).
English: 20 ml packed with 2 dosing devices of 1 ml 50 ml packed with 2 dosing devices of 3 ml 150 ml packed with 2 dosing devices of 10 ml
Maltese: 20 ml ippakkjati b'2 strumenti tad-dożaġġ ta' 1ml 50 ml ippakkjati b'2 strumenti tad-dożaġġ ta' 3ml 150 ml ippakkjati b'2 strumenti tad-dożaġġ ta' 10ml
English: Advice for Veterinarian:
Maltese: Kodiċi ATC veterinarja:
English: In a 3-month study, exposures were 2 times higher at Day 29 but returned to Day 1 values at days 56 and 87.
Maltese: Fi studju ta' 3 xhur, l-esponimenti kienu darbtejn ogħla f'Jum 29 imma reġgħu lura għal valuri ta' Jum 1 fil-ġranet 56 u 87.
English: DOSAGE FOR EACH SPECIES, ROUTE AND METHOD OF ADMINISTRATION
Maltese: DOŻA GĦAL KULL SPEĊJE, MOD U METODU TA' AMMINISTRAZZJONI
English: Date of first authorisation: 13/04/2007
Maltese: DATA TAL -EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtoriżżazzjoni: 13/04/2007
English: 5 (conditional)
Maltese: ATTIVA(I)
English: Polypropylene bottles of 20, 50 and 150 ml fitted with a low density polyethylene (LDPE) Press-In-bottle adapter and a child resistant closure.
Maltese: Fliexken tal-polipropilin ta' 20, 50 u 150 ml iffittjati b'adattament Press-in tal-polietilin ta' densità baxxa (LDPE) għall-flixkun u għatu li ma jistgħux jiftħuh it-tfal.
English: Slentrol 5 mg/ml oral solution for dogs
Maltese: Slentrol 5mg/ml soluzzjoni orali għall-klieb
English: Dose 1 = Starting dose = Initial BW x
Maltese: Doża 1 = Doża tal-bidu = BW Inizjali x
English: In the treatment phase, because food intake is reduced as when using a traditional non-medical calorie restriction method, care must be taken to ensure that protein, vitamins, essential fatty acids and minerals supplied by the consumed daily food ration meet minimal recommended requirements in order to ensure a complete and balanced nutritional supply.
Maltese: Matul it-trattament, peress li assorbiment ta' l-ikel jonqos bħal meta jkun użat metodu mhux mediku tradizzjonali ta' restrizzjoni tal-kaloriji, wieħed għandu joqgħod attent biex jiżgura li proteini, vitamini, aċidi tax-xaħam essenzjali u minerali li jingħataw bir-razzjon ta' ikel ta' kuljum jissodisfaw kondizzjonijiet minimali rrakkomandati biex tkun żgurata li qed jingħata forniment nutrit komplet u bbalanċjat,
English: A colourless to pale yellow solution.
Maltese: Soluzzjoni bejn trasparenti u safra pallida.
English: In clinical studies, vomiting, sometimes accompanied by signs of lethargy, anorexia or diarrhoea was observed during treatment with the veterinary medicinal product.
Maltese: Fi studji kliniċi, remettar, xi kultant akkumpanjat minn sinjali ta' letarġija, anoreksja jew dijarea kienu osservati matul it-trattament bil-prodott mediċinali veterinarju.
English: Additionally, dirlotapide was highly protein bound (>99%) in dog plasma.
Maltese: Barra minn dan, dirlotapide hu marbut ħafna mal-proteina (>99%) fil
English: Slovenija
Maltese: Lietuva
English: Detailed information on this product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediċinali veterinarju tinstab fuq il-websajt ta' l-Aġenzija Ewropea dwar il-Mediċini http://www.ema.europa.eu/.
English: Resolution of adverse reactions will occur shortly after suspension of treatment.
Maltese: Ir- reazzjonijiet avversi li ser isseħu, imorru ftit wara s-sospenzjoni tat-trattament.
English: Interactions with other drug types have not been specifically investigated.
Maltese: Interazzjonijiet ma' tipi oħra ta' mediċini ma ġewx speċifikament investigati.
English: Zoetis Hellas S.A.
Maltese: Zoetis Lietuva UAB
English: DOSE PROGRESSION TABLE DURING WEIGHT LOSS
Maltese: TAL-PROGRESS TAD-DOŻA MATUL
English: 6.3 Shelf life
Maltese: IT-TELF TAL
English: Sími: +354 540 80 00
Maltese: Tel: +370 525 12029
English: Dirlotapide 5 mg/ml is a colourless to pale yellow solution.
Maltese: U INGREDJENT(I) OĦRA Dirlotapide 5mg/ml ippreżentat bħala soluzzjoni ta' kulur bejn trasparenti u safra pallida.
English: AUC and Cmax increased with increasing dose but not in a dose-proportional manner.
Maltese: AUC u Cmax żdiedu b'doża ogħla imma mhux b'mod proporzjonali mad-doża.
English: After two weeks of therapy, the initial dose (number of ml administered) should be increased by 100% (doubled).
Maltese: Wara ġimgħatejn ta' terapija, id-doża inizjali (numru ta' ml mogħtija) għandha tkun miżjuda b'100% (irdupjata).
English: Mean oral bioavailability values were approximately 24% - 41% for fed dogs and 22% in fasted dogs.
Maltese: Il-valuri medji talbiodisponibilità orali kienu bejn wieħed u ieħor 24%- 41% għal klieb li ngħataw l-ikel u 22% għal klieb li kellhom isumu.
English: The recommended starting dose of the veterinary medicinal product is 0.05 mg/kg initial bodyweight per day (0.01 ml/kg/day).
Maltese: Id-dożaġġ rrakkomandat inizjali tal-prodott mediċinali veterinarju hu 0.05 mg/kg tal-piż inizjali talġisem kull ġurnata (0.01 ml/kg/kuljum).
English: Sporadic and mild serum alanine aminotransferase (ALT) elevations up to 4 times the upper reference range are not a reason for discontinuing therapy in the absence of any indication of liver dysfunction.
Maltese: Elevazzjonijiet sporadiċi u mhux qawwija ta' alanini aminotransferasi (ALT) tas-serum sa erba' darbiet ogħla l-firxa ta' referenza m'għandhomx ikunu raġuni għala t-terapija għandha titwaqqaf fin-nuqqas ta' kwalunkwe indikazzjoni ta' anormalità tal-fwied.
English: Dose 1 = Starting dose = Initial BW x weighing
Maltese: Doża 1 = Doża tal-bidu = BW Inizjali
English: Oral use.
Maltese: U/JEW UŻU Mhux applikabbli.
English: This is consistent with in vivo data generated in mice which shows that dirlotapide has selectivity for intestinal MTP.
Maltese: Dan hu konsistenti ma' tagħrif in vivo ġġenerat fil-ġrieden li juru li dirlotapide għandu selettività għall-MTP intestinali.
English: Some dogs (less than 10%) experienced repeated vomiting (i.e. more than once every 20 days on average).
Maltese: Xi klieb (inqas minn 10%) esperjenzaw każi ripetuti ta' rramettar (p.e medja ta' aktar minn darba waħda kull 20 ġurnata ).
English: Slentrol may cause eye-irritation.
Maltese: Slentrol għandu mnejn jikkawża irritazzjoni fl-għajnejn.
English: Read the package leaflet before use.
Maltese: Mhux id-daqs kollha tal-pakketti jistgħu qegħdin fis-suq.
English: The recommended starting dose of Slentrol is 0.05 mg/kg (0.01ml/kg) by oral administration.
Maltese: Id-doża rrakkomandata inizjali ta' Slentrol hi 0.05mg/kg (0.01 ml/kg) li jittieħed mill-ħalq.
English: Use in dogs intended for breeding should be subject to a risk-benefit analysis (see section 4.7).
Maltese: L-użu fil-klieb tar-razza għandu ikun soġġett għall-analiżi ta' riskju-benefiċċju (ara sezzjoni 4.7).
English: The inhibition of intestinal and hepatic MTP reduces plasma cholesterol and triglyceride concentration.
Maltese: L-inibizzjoni tal-MTP intestinali u tal-fwied tnaqqas il-konċentrazzjon tal-kolesterol fil-plażma u trigliċerida.
English: 3% bodyweight loss per month = 0.7% per week = 0.1% per day The lowest validated dose for the dosing device is 0.05 ml.
Maltese: telf tal-piż fil-ġisem fix-xahar ta' 3% = 0.7% fil-ġimgħa = 0.1% kuljum L-aktar doża baxxa u validata għall-strument tad-dożaġġ hi 0.05 ml.
English: Overdose up to 10 times the maximum authorised dose of 1 mg/kg current bodyweight may produce vomiting or diarrhoea or increased ALT/AST (alanine aminotransferase/aspartate aminotransferase) levels.
Maltese: Doża eċċessiva sa 10 darbiet il-massimu tad-doża awtorizzata ta' 1 mg/kg tal-piż kurrenti tal-ġisem għandha mnejn tipproduċi rramettar jew dijarea jew livelli ogħla ta' ALT/AST (alanine aminotransferase/aspartate aminotransferase).
English: 5.1 Pharmacodynamic properties
Maltese: KWALITAJIET FARMAKOLOĠIĊI
English: Sporadic and mild ALT (alanine aminotransferase) elevations up to 4 times the upper reference range and not associated with histopathological liver lesions or noticeable changes in other liver parameters may be observed in some dogs during the course of treatment.
Maltese: Elevazzjonijiet sporadiċi u mhux qawwija ta' ALT (alanine aminotransferase) sa 4 darbiet il-firxa ogħla tar-referenza u mhux assoċjati mal-leżjonijiet istopatoloġikali fil-fwied jew tibdil notevoli f'parametri oħra tal-fwied għandhom mnejn ikunu osservati f'xi klieb matul il-kors tat-trattament.
English: PHARMACOLOGICAL PROPERTIES
Maltese: TA' PRODOTTI MHUX
English: MTP inhibitors (microsomal trigylyceride transfer protein inhibitors) as a class have the potential to disrupt yolk sac development and laboratory studies on rats and rabbits have shown evidence of embryolethality, teratogenicity, and developmental
Maltese: Inibituri MTP (inibituri ta' proteini ta' transfer ta' microsomal trigylyceride) bħala klassi, għandhom il-potenzjal li jfixxklu l-iżvilupp talmembrana li tagħlaq go fiha l-isfar tal-bajda u studji fil-laboratorji fuq firien u fniek pprovdew evidenza ta' embrijuletalità, ħsara fit-tqala, u ħsara fl-iżvilupp.
English: According to clinical studies, a mean weight loss of about 18 to 20% after six months of weight loss
Maltese: Skond studji kliniċi, telf medju fil-piż ta' minn madwar minn 18 sa 20% wara sitt xhur ta' terapija tat
English: MTP (Microsomal Trigylyceride transfer Protein) inhibitors as a class have the potential to disrupt yolk sac development and laboratory studies on rats and rabbits have shown evidence of embryolethality, teratogenicity, and developmental toxicity.
Maltese: Inibituri MTP (inibituri ta' proteini ta' trasferiment ta' microsomal trigylyceride) bħala klassi, għandhom il-potenzjal li jfixklu l-iżvilupp tal-membrana li tagħlaq ġo fiha l-isfar tal-bajda u studji fil-laboratorji fuq firien u fniek pprovdew evidenza ta' mewt tal-embriju, ħsara fit-tqala, u ħsara fl-iżvilupp.
English: Τηλ.
Maltese: L-ISEM
English: When the veterinary medicinal product is drawn into syringe, administer immediately.
Maltese: Staqsi lill-kirurgu veterinarju tiegħek dwar kif l-aħjar li tarmi l-mediċini li ma jkunux aktar meħtieġa.
English: Italia
Maltese: Luxembourg
English: Pharmacotherapeutic group: Peripherally acting antiobesity products.
Maltese: Grupp farmako-terapewtiku:
English: According to clinical studies, a mean weight loss of about 18 to 20% after six months of weight loss therapy can be anticipated.
Maltese: Skond studji kliniċi, telf medju fil-piż ta' minn madwar 18 sa 20% wara sitt xhur ta' terapija jista' jkun
English: 4.11 Withdrawal period
Maltese: 4.11 Perjodu ta' tiżmim Mhux applikabbli.
English: Special precautions to be taken by the person administering the veterinary medicinal product to dogs: The veterinary medicinal product does not mix with water.
Maltese: Fin-nuqqas ta' studji dwar kompatibilità, dan il-prodott mediċinali veterinarju ma jistax jintuża flimkien ma prodotti mediċinali veterinarji oħra.
English: Manufacturer responsible for batch release:
Maltese: Manifattur responsabbli għall-ħrug tal-lott:
English: Dosing may be recommenced at the same or at a reduced dose volume (reduced by 25%), but if vomiting reoccurs, the veterinary medicinal product may
Maltese: Id-dożaġġ għandu mnejn ikun rrakkomandat flistess jew f'volum ta' doża mnaqqsa, (imnaqqsa b'25%), imma jekk jerġa' jibda remettar, għandu mnejn ikun hemm bżonn it-tneħħija tal-prodott mediċinali veterinarju.
English: In subsequent required conditional increases, the dose should be increased by 50% (increasing the dose volume to 1.5 times the volume administered in the previous month) up to a maximum dose of the veterinary medicinal product of 0.2 ml/kg current bodyweight.
Maltese: F'żjidiet kondizzjonali meħtieġa sussegwenti, id-doża għandha tkun miżjuda b'50% (il-volum tad-doża għandu jkun miżjud għall-1.5 darba tal-volum mogħti fix-xahar ta' qabel) sad-doża massima tal-prodott mediċinali veterinarju ta' 0.2 ml/kg tal-piż kurrenti tal-ġisem.
English: Systemic exposure was 1.5 times higher in fed dogs.
Maltese: L-esponiment sistemiku kien 1.5 darba ogħla għal klieb li ngħataw l-ikel.
English: Icepharma hf.
Maltese: La darba jinfetaħ, użah fi żmien 3 xhur
English: Bottles of 150 ml are packed with two dosing devices of 10 ml.
Maltese: Flixken ta' 150 ml huma ppakkjati b'żewġ strumenti tad-dożaġġ ta' 10ml.
English: In a radiolabeled metabolism study, the primary route of excretion was via the faeces with minimal excretion via urine (<1%).
Maltese: Fi studju ta' metaboliżmu radjutikkettat, il-kanal primarju tat-tneħħija kien milll-ħmieġ bi tneħħija minima mill-awrina (<1%).
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals
Maltese: Prekawzjonijiet speċjali li għandhom jittieħdu mill-persuna li tamministra l-prodott mediċinali veterinarju
English: Av. Baix Llobregat, 3 y 5 08970 Sant Joan DespiBarcelona
Maltese: Baix Llobregat, 3 y 5 08970 Sant Joan DespiBarcelona
English: QUÍMICA FARMACEUTICA BAYER, S. L.
Maltese: BAYER, S. L.
English: This procedure is a referral following a Mutual Recognition Procedure concerning the above variation application which was submitted for Actira film-coated tablets to Germany as Reference Member State (RMS) and the Concerned Member States (CMS) AT, BE, DK, EL, ES, FI, IT, LU, PT and SE on 5 December 2006.
Maltese: Din il-proċedura hija riferiment wara Proċedura ta' Għarfien Reċiproku dwar l-applikazzjoni talvarjazzjoni msemmija fuq li ġiet sottomessa għall-pilloli miksijin b'rita ta' Actira lill-Ġermanja bħala Stat Membru ta' Referenza (RMS) u lill-Istati Membri Konċernati (CMS) AT, BE, DK, EL, ES, FI, IT, LU, PT u SE fil-5 ta' Diċembru ta' l-2006.
English: LU - Luxembourg Bayer Healthcare AG 51368 Leverkusen
Maltese: LU - Lussemburgu Bayer Healthcare AG 51368 Leverkusen
English: Actira was initially approved in June 1999.
Maltese: Actira kien approvat inizjalment f'Ġunju ta' l-1999.
English: Pharmaceutical Form
Maltese: QUÍMICA FARMACEUTICA
English: Bayer AG 51368 Leverkusen Germany
Maltese: Bayer AG 51368 Leverkusen Ġermanja
English: The MRP variation application DE/H/158/01/II/32 concerned an extension of the indication to include the treatment of mild to moderate pelvic inflammatory disease (PID), i.e. infections of upper genital tract, including salpingitis and endometritis.
Maltese: L-applikazzjoni tal-varjazzjoni ta' l-MRP DE/H/158/01/II/32 kienet dwar estensjoni ta' l-indikazzjoni biex ikun inkluż it-trattament tal-marda infjammatorja tal-pelvis (PID) moderata jew severa, jiġifieri infezzjonijiet tal-parti ta' fuq tal-passaġġ ġenitali, inklużi s-salpinġite u l-endometrite.
English: - If you are under 18 years of age.
Maltese: - Jekk għandek età taħt 18-il sena.
English: - The Committee considered that robust data is available showing the efficacy of Actira in the indication “Treatment of mild to moderate pelvic inflammatory disease (PID), i.e. infections of upper genital tract, including salpingitis and endometritis” , however due to emerging resistance of N. gonorrhoeae, moxifloxacin should not be used in empirical monotherapy, unless moxifloxacinresistant N. gonorrhoeae can be excluded.
Maltese: - Il-Kumitat ikkunsidra li hemm dejta robusta li turi l-effikaċja ta' Actira fl-indikazzjoni “Trattament ta' mard infjammatorju tal-pelvis (PID) ħafif jew moderat, jiġifieri infezzjonijiet tal-passaġġ ġenitali ta' fuq, inklużi s-salpinġite u l-endometrite”, madankollu minħabba r-reżistenza li qed tiżviluppa minn N. gonorrhoeae, moxifloxacin m'għandux jintuża fil-monoterapija empirika, sakemm ma tkunx tista' tiġi eskluża razza ta' N. gonorrhoeae reżistenti għal moxifloxacin.
English: Germany
Maltese: Roma
English: - The Committee considered the Referral made under Article 6(12) of Commission Regulation (EC) No 1084/2003, for Actira and associated names (See Annex 1).
Maltese: - Il-Kumitat ikkunsidra r-Riferiment magħmul skond l-Artikolu 6(12) tar-Regolament talKummissjoni (KE) Nru 1084/2003, għal Actira u ismijiet assoċjati (ara l-Anness 1).
English: Actira film-coated tablets contain 400 mg moxifloxacin as hydrochloride.
Maltese: Il-pilloli miksijin b'rita ta' Actira fihom 400 mg moxifloxacin bħala idroklorur.
English: Film-coated tablet
Maltese: TAS-SOMMARJU TAL-KARATTERISTIĊI
English: EU/1/18/1335/001 POTELIGEO 4 mg/ml
Maltese: EU/1/18/1335/001 POTELIGEO 4 mg/ml Konċentrat għal soluzzjoni għall-infużjoni
English: Intravenous use Vial (glass)
Maltese: Użu għal ġol-vini kunjett (ħġieġ)
English: Treatment TruScient + SOC (n=84) SOC (n=42) SOC = standard of care
Maltese: TruScient + SOC (n=84) SOC (n=42)
English: Sponge for TruScient
Maltese: Sponża għal TruScient