FrancophonIA/ELRC3.0 huggingface dataset:
English: After inhaling, patients should rinse their mouth or gargle with water without swallowing it or brush their teeth (see sections 4.2 and 4.4).
Maltese: Wara l-inalazzjoni, il-pazjenti għandhom ilaħalħu ħalqhom jew jiggargarizzaw bl-ilma mingħajr ma jibilgħuh jew jaħslu snienhom (ara sezzjonijiet 4.2 u 4.4).
English: A responder analysis showed that a significantly greater percentage of patients had a clinically significant improvement (reduction versus baseline of greater than or equal to 4) after 26 and 52 weeks with Riarify than with a fixed combination of beclometasone dipropionate and formoterol and with tiotropium.
Maltese: dawk li rrispondew uriet li perċentwali ogħla b'mod sinifikanti ta' pazjenti kellhom titjib klinikament sinifikanti (tnaqqis kontra l-linja bażi ta' aktar minn jew ugwali għal 4) wara 26 u 52 ġimgħa b‘Riarify milli b'kombinazzjoni fissa ta' beclometasone dipropionate u formoterol u b'tiotropium.
English: • flu
Maltese: • għeja
English: Asthenia
Maltese: Ipersomnja
English: • muscle cramps and pain in muscles
Maltese: .8 Effetti mhux mixtieqa
English: Ear and labyrinth disorders Otosalpingitis1
Maltese: Rogħda, sturdament, tibdil fis-sens tat-togħma1, ipoestesija1
English: Faecal excretion is the major route of beclometasone dipropionate elimination mainly as polar metabolites.
Maltese: It-tneħħija fl-ippurgar hija r-rotta ewlenija tal-eliminazzjoni ta' beclometasone dipropionate, il-biċċa l-kbira bħala metaboliti polari.
English: • medicines for treating - abnormal heart rhythms (quinidine, disopyramide, procainamide), - allergic reactions (antihistamines), - symptoms of depression or mental disorders such as monoamine oxidase inhibitors (for example phenelzine and isocarboxazid), tricyclic antidepressants (for example amitriptyline and imipramine), phenothiazines can cause some changes in the electrocardiogram (ECG, heart trace).
Maltese: • Disulfiram, mediċina li tintuża fit-trattament ta' persuni bl-alkoħoliżmu (problemi tax-xorb) jew metronidazole, antibijotiku għat-trattament ta' infezzjoni fil-ġisem tiegħek jistgħu jikkawżaw effetti sekondarji (eż. tħossok imdardar, tirremetti, uġigħ fl-istonku) minħabba l-ammont żgħir ta' alkoħol fi Riarify.
English: EU/2/17/221/001-006
Maltese: FIS-SUQ EU/2/17/221/001-006
English: 26 Rue de la Chapelle 68330 Huningue France
Maltese: Elanco France S.A.S. 26 Rue de la Chapelle 68330 Huningue Franza
English: EU/2/17/221/001 (20 mg, 7 tablets, 20 ml bottle) EU/2/17/221/002 (20 mg, 30 tablets, 20 ml bottle) EU/2/17/221/003 (60 mg, 7 tablets, 20 ml bottle) EU/2/17/221/004 (60 mg, 30 tablets, 35 ml bottle) EU/2/17/221/005 (100 mg, 7 tablets, 35 ml bottle) EU/2/17/221/006 (100 mg, 30 tablets, 60 ml bottle)
Maltese: EU/2/17/221/001 (20 mg, 7 pilloli, flixkun ta' 20 mL) EU/2/17/221/002 (20 mg, 30 pillola, flixkun ta' 20 mL) EU/2/17/221/003 (60 mg, 7 pilloli, flixkun ta' 20 mL) EU/2/17/221/004 (60 mg, 30 pillola, flixkun ta' 35 mL) EU/2/17/221/005 (100 mg, 7 pilloli, flixkun ta' 35 mL) EU/2/17/221/006 (100 mg, 30 pillola, flixkun ta' 60 mL)
English: This difference in favour of Galliprant was statistically significant (p-value= 0.0008).
Maltese: Din id-differenza favur Galliprant kienet statistikament sinifikanti (valur p=0.0008).
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 09/01/2018
Maltese: Data tal-ewwel awtorizzazzjoni: 09/01/2018
English: Dose range (mg/kg bw)
Maltese: (mg/kg bw)
English: Pork liver powder Lactose monohydrate Sodium starch glycolate Type A Sodium laurilsulfate Copovidone
Maltese: Trab tal-fwied tal-majjali Lactose monohydrate Sodium starch glycolate Tip A Sodium laurilsulfate Copovidone
English: The elimination half-life of grapiprant is approximately 4.6 to 5.67 hours.
Maltese: Il-half-life tal-eliminazzjoni ta' grapiprant hi ta' madwar 4.6 sa 5.67 sigħat.
English: The mean percentage of unbound grapiprant was 4.35% and 5.01% at a grapiprant concentration of 200 ng/ml and 1000 ng/ml.
Maltese: Il-perċentwali medji ta' grapiprant mhux imwaħħal kienu ta' 4.35% u 5.01% f'konċentrazzjoni ta' grapiprant ta' 200 ng/mL u 1000 ng/mL.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/17/221/006 (100 mg, 30 tablets, 60 ml bottle)
Maltese: EU/2/17/221/006 (100 mg, 30 pillola, flixkun ta' 60 mL)
English: ROUTE(S) OF ADMINISTRATION Oral use
Maltese: MOD(I) TA' AMMINISTRAZZJONI
English: Four metabolites are identified and the metabolic pathways include Ndeamination to form the major metabolite in faeces (7.2%) and urine (3.4%).
Maltese: Erba' metaboliti ġew identifikati, u l-passaġġi metaboliċi jinkludu N-deamination biex tifforma l-metabolit maġġuri fl-ippurgar (7.2%) u fl-awrina (3.4%).
English: 2.5x and 15x the recommended dose.
Maltese: kuljum ta' madwar 2.5x u 15x tad-doża rakkomandata.
English: Do not store above 30 °C.
Maltese: Taħżinx f'temperaturi ogħla minn 30°C.
English: From the two clinical field studies, the overall success rates based on CBPI (Canine Brief Pain Inventory, as completed by the owner) at 28 days after the start of the treatment, were 51.3% (120/235) for Galliprant and 35.5% (82/231) for the placebo group.
Maltese: Pain Inventory, kif mimlija mis-sid) 28 jum wara l-bidu tat-trattament, kienu ta' 51.3% (120/235) għal Galliprant, u 35.5% (82/231) għall-grupp tal-plaċebo.
English: Grapiprant is a methylbenzenesulfonamide.
Maltese: Grapiprant hu methylbenzenesulfonamide.
English: Grapiprant is primarily bound to serum proteins.
Maltese: Grapiprant jeħel prinċipalment mal-proteini fis-serum.
English: After a single oral dose of 2 mg grapiprant/kg, Cma x and AUC values of 1.21 µg/ml and 2.71 µg.h/ml were reached in the fasted state.
Maltese: Wara doża orali waħda ta' 2 mg ta' grapiprant/kg, valuri tas-Cmax u tal-AUC ta' 1.21 µg/ml u 2.71 µg.h/ml intlaħqu fl istat sajjem.
English: 100 mg For the full list of excipients, see section 6.1.
Maltese: 100 mg Għal-lista sħiħa tal-ingredjenti (mhux attivi), ara s-sezzjoni 6.1.
English: 6.2 Major incompatibilities Not applicable.
Maltese: .2 Inkompatibilitajiet maġġuri
English: PACKAGE SIZE 7 tablets
Maltese: DAQS TAL-PAKKETT 7 pilloli
English: Galliprant 100 mg tablets grapiprant
Maltese: Galliprant 100 mg pilloli grapiprant
English: Elanco GmbH Heinz-Lohmann-Str. 4 27472 Cuxhaven Germany
Maltese: 4 27472 Cuxhaven
English: Intake of the tablet with food reduces the oral bioavailability, i.e. the oral bioavailability of grapiprant when taken in the fasted state was 89% and when taken with food it was 33%, with mean Cmax and AUC grapiprant values reduced 4-fold and 2-fold, respectively.
Maltese: It-teħid tal-pillola mal-ikel inaqqas il-bijodisponibilità orali, i.e. ilbijodisponibilità orali ta' grapiprant meta ttieħed fl-istat sajjem kienet ta' 89%, u meta ttieħed mal-ikel kienet ta' 33%, bil-medja tal-valuri tas-Cmax u tal-AUC ta' grapiprant li tnaqqsu b'4 darbiet u b'darbtejn, rispettivament.
English: - 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: - rari (aktar minn wieħed iżda inqas minn 10 annimali f'10,000 annimal) - rari ħafna (inqas minn annimal wieħed f'10,000 annimal, inklużi rapporti iżolati).
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) 20 mg grapiprant
Maltese: ATTIVA(I) 20 mg grapiprant
English: Lactation:
Maltese: Tqala:
English: PACKAGE SIZE 30 tablets
Maltese: DAQS TAL-PAKKETT 30 pillola
English: A clinical response to treatment is usually seen within 7 days.
Maltese: Rispons kliniku għat-trattament ġeneralment jiġi osservat fi żmien 7 ijiem.
English: Pharmacotherapeutic group: Other anti-inflammatory and antirheumatic agents, non-steroids ATCvet code:
Maltese: Sustanzi oħra antinfjammatorji u antirewmatiċi, mhux sterojdi Kodiċi ATC veterinarja:
English: Mild decreases in serum albumin and total protein, most often within the reference range, have been observed in dogs treated with grapiprant but were not associated with any clinically significant observations or events.
Maltese: Tnaqqis ħafif tal-albumina fis-serum u tal-proteina totali, l-aktar ta' spiss fil-medda ta' referenza, ġie osservat fi klieb ikkurati bi grapiprant, iżda ma kienx assoċjat ma' xi osservazzjonijiet jew avvenimenti klinikament sinifikanti.
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) 100 mg grapiprant
Maltese: ATTIVA(I) 100 mg grapiprant
English: The specific effects of the binding of prostaglandin E2 to the EP4 receptor include vasodilation, increased vascular permeability, angiogenesis and production of pro‐inflammatory mediators.
Maltese: L-effetti speċifiċi tat-twaħħil ta' prostaglandin E2 mar-riċettur ta' EP4 jinkludu vasodilatazzjoni, żieda fil-permeabilità vaskulari, anġjoġenesi u l-produzzjoni ta' medjaturi proinfjammatorji.
English: 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary In healthy dogs treated with grapiprant for 9 consecutive months, mild and transient soft-formed or mucous faeces, occasionally bloody, and vomiting were observed at daily overdoses of approximately
Maltese: 4.10 Doża eċċessiva (sintomi, proċeduri ta' emerġenza, antidoti), jekk ikun hemm bżonn Fi klieb b'saħħithom ittrattati bi grapiprant għal 9 xhur konsekuttivi, każijiet ħfief u temporanji ta' ppurgar artab jew bil-mukus, u xi kultant bid-demm, u rimettar, ġew osservati f'dożi eċċessivi ta'
English: The veterinary medicinal product is available in the following pack sizes:
Maltese: Il-prodott mediċinali veterinarji hu disponibbli fid-daqsijiet tal-pakkett li ġejjin:
English: Pack sizes of 7 and 30 tablets per bottle.
Maltese: Daqsijiet tal-pakkett ta' 7 jew 30 pillola f'kull flixkun.
English: Galliprant 20 mg tablets Galliprant 60 mg tablets Galliprant 100 mg tablets grapiprant
Maltese: Galliprant 20 mg pilloli Galliprant 60 mg pilloli Galliprant 100 mg pilloli grapiprant
English: Grapiprant is a selective antagonist of the EP4 receptor, a key prostaglandin E2 receptor that predominantly mediates prostaglandin E2‐elicited nociception.
Maltese: Grapiprant hu antagonist selettiv tar-riċettur ta' EP4, riċettur ewlieni ta' prostaglandin E2 li jagħmel medjazzjoni b'mod predominanti prostaglandin E2 elicited nociception.
English: Elanco France S.A.S.
Maltese: JJ xahar SSSS
English: Faecal excretion accounted for roughly 65% of the dose whereas approximately 20% of the dose was excreted through urine.
Maltese: L-eliminazzjoni fl-ippurgar kienet tammonta għal madwar 65% tad-doża, filwaqt li bejn wieħed u ieħor 20% tad-doża ġiet eliminata mal awrina.
English: Two hydroxylated metabolites and one N-oxidated metabolite are also recovered in bile, faeces and/or urine.
Maltese: Iż żewġ metaboliti hydroxylated u metabolit wieħed N-oxidated jiġu rkuprati wkoll fil-bili, fl-ippurgar u/jew fl-awrina.
English: The EP4 receptor is important in mediating pain and inflammation as it is the primary mediator of the prostaglandin E2-elicited sensitization of sensory neurons and prostaglandin E2-elicited inflammation.
Maltese: Ir-riċettur ta' EP4 hu importanti fil-medjazzjoni tal-uġigħ u tal-infjammazzjoni għax hu l-medjatur primarju tas-sensitizzazzjoni ta' prostaglandin E2-elicited tan-newroni sensorjali u infjammazzjoni kkawżata minn prostaglandin E2.
English: DD month YYYY
Maltese: HUWA INDIKAT IL-PRODOTT
English: The safety of the veterinary medicinal product has not been established in dogs under 9 months of age and in dogs weighing less than 3.6 kg.
Maltese: Is-sigurtà tal-prodott mediċinali veterinarju ma ġiex stabbilit fi klieb li jkollhom inqas minn 9 xhur u fi klieb li jiżnu inqas minn 3.6 kg.
English: SPECIAL STORAGE CONDITIONS Do not store above 30 °C.
Maltese: Taħżinx f'temperatura 'l fuq minn 30°C.
English: 100 mg tablet: A brown speckled, biconvex oval tablet with a score on one face separating the debossed number ‘100' on one half and the letters ‘MG' on the other half; the letter ‘G' is debossed on the other face.
Maltese: Pillola ta' 100 mg: Pillola ovali bikonvessa, kannella u bit-tikek, b'ferq fuq naħa waħda li jissepara nnumru mnaqqax ‘100' fuq nofs wieħed, u l-ittri ‘MG' fuq in-nofs l-ieħor; l-ittra ‘G' hija mnaqqxa fuq in-naħa l-oħra.
English: The pharmacological activity of the metabolites is not known.
Maltese: L-attività farmakoloġika tal-metaboliti mhijiex magħrufa.
English: Induction sealed, white, round high density polyethylene (HDPE) bottles (20, 35, and 60 ml) with a threaded child-resistant cap with rayon coil.
Maltese: In-natura u l-għamla tal-ippakkjar li jmiss mal-prodott Fliexken tal-polyethylene bojod u tondi, ta' densità għolja (HDPE), issiġillati permezz tal-induzzjoni (20, 35 u 60 mL) b'għatu bil-kamini reżistenti għall-ftuħ mit-tfal, b'kojl tar-rayon.
English: 60 mg tablet: A brown speckled, biconvex oval tablet with a score on one face separating the debossed number ‘60' on one half and the letters ‘MG' on the other half; the letter ‘G' is debossed on the other face.
Maltese: Pillola ta' 60 mg: Pillola ovali bikonvessa, kannella u bit-tikek, b'ferq fuq naħa waħda li jissepara nnumru mnaqqax ‘60' fuq nofs wieħed, u l-ittri ‘MG' fuq in-nofs l-ieħor; l-ittra ‘G' hija mnaqqxa fuq in-naħa l-oħra.
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reactions during the course of one treatment)
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 matul il-perjodu ta'
English: 20 mg tablet: A brown speckled, biconvex oval tablet with a score on one face separating the debossed number ‘20' on one half and the letters ‘MG' on the other half; the letter ‘G' is debossed on the other face.
Maltese: Pillola ta' 20 mg: Pillola ovali bikonvessa, kannella u bit-tikek, b'ferq fuq naħa waħda li jissepara nnumru mnaqqax ‘20' fuq nofs wieħed, u l-ittri ‘MG' fuq in-nofs l-ieħor; l-ittra ‘G' hija mnaqqxa fuq in-naħa l-oħra.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard box (20 ml, 35 ml and 60 ml bottles)
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ IL-PAKKETT TA' BARRA Kaxxa tal-kartun (għall-fliexken ta' 20 mL, 35 mL and 60 mL)
English: If no clinical improvement is apparent after 14 days, treatment with Galliprant should be discontinued and different treatment options should be explored in consultation with the veterinarian.
Maltese: Jekk ma jkun jidher ebda titjib kliniku wara 14-il jum, il-kura b'Galliprant għandha titwaqqaf, u għażliet ta' kura differenti għandhom jiġu esplorati f'konsultazzjoni mal-veterinarju.
English: 4.11 Withdrawal period(s) Not applicable.
Maltese: 4.11 Perjodu ta' tiżmim Mhux applikabbli.
English: Grapiprant is a non-steroidal, non-cyclooxygenase inhibiting, anti-inflammatory drug in the piprant class.
Maltese: Grapiprant hu mediċina mhux sterojdi, mediċina kontra l-infjammazzjoni, li ma tinibixxix lil cyclooxygenase, fil-klassi piprant.
English: In very rare cases, haematemesis or haemorrhagic diarrhoea was reported following clinical use post authorisation in the USA.
Maltese: F'każijiet rari ħafna, ematemesi jew dijarea emorraġika ġew irrappurtati wara l-użu kliniku wara l awtorizzazzjoni fl-Istati Uniti tal-Amerika.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Bottle (20 and 35 ml)
Maltese: JMISS MAL-PRODOTT Flixkun (20 u 35 mL)
English: It is not known whether dogs with a history of hypersensitivity to sulphonamides will exhibit hypersensitivity to grapiprant.
Maltese: Mhux magħruf jekk klieb bi storja ta' sensittività eċċessiva għal sulfonamidi humiex se juru sensittività eċċessiva għal grapiprant.
English: The majority of clinical cases assessed in the clinical field studies suffered from mild to moderate osteoarthritis based on the veterinary assessment.
Maltese: Il-maġġoranza tal-każijiet kliniċi evalwati fl-istudji kliniċi fuq il-post sofrew minn osteoartrite ħafifa sa moderata abbażi tal-valutazzjoni veterinarja.
English: The concomitant use of protein-bound veterinary medicinal products with grapiprant has not been studied.
Maltese: L-użu fl-istess ħin ta' prodotti mediċinali veterinarji li jeħlu mal-proteini, flimkien ma' grapiprant, ma ġiex studjat.
English: To achieve a substantiated response to treatment, use the veterinary medicinal product only in mild and moderate cases of osteoarthritis.
Maltese: uża l-prodott mediċinali veterinarju biss f'każijiet ta' osteoartrite ħafifa u moderata.
English: 60 mg grapiprant/tablet
Maltese: 20 mg grapiprant/pillola 60 mg grapiprant/pillola 100 mg grapiprant/pillola
English: Wash hands after handling of the veterinary medicinal product.
Maltese: Aħsel idejk wara li timmaniġġja l-prodott mediċinali veterinarju.
English: In vitro protein binding of grapiprant indicates that grapiprant is primarily bound to dog serum albumin.
Maltese: It-twaħħil in vitro ta' grapiprant mal-proteini jindika li grapiprant jeħel prinċipalment mal-albumina fis-serum tal-kelb.
English: Ελλάδa ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε.
Maltese: ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε.
English: Problem
Maltese: Problema
English: Other Important Notes
Maltese: Noti Importanti Oħra
English: INFORMATION IN BRAILLE FORSTEO
Maltese: INFORMAZZJONI BIL-BRAILLE FORSTEO
English: 2.6% d
Maltese: 2.6% c
English: 1.5% d
Maltese: 1.5% c
English: Rare: may affect up to 1 in 1,000 people
Maltese: Rari: jistgħu jolqtu sa persuna 1 minn kull 1,000
English: Common: Palpitations
Maltese: Komuni: Palpitazzjonijiet
English: • Pregnancy and breast-feeding (see sections 4.4 and 4.6)
Maltese: • Tqala u treddigħ (ara sezzjonijiet 4.4 u 4.6)
English: Relative risk (95% CI) vs. placebo
Maltese: Riskju relativ (95% CI)
English: Multiple vertebral fractures (≥2) a
Maltese: Ksur multiplu vertebrali(≥2) a
English: Boehringer-Ingelheim RCV GmbH & Co KG, Dr.-Boehringer-Gasse 5-11, 1121 Vienna, Austria
Maltese: KG, Dr.-Boehringer-Gasse 5-11, 1121 Vienna, L-Awstrija
English: Instead, you MUST reset FORSTEO (see Troubleshooting Problem A).
Maltese: tissettja l-FORSTEO (ara Problemi li jista' jkollok Problema A).
English: *Teriparatide, rhPTH(1-34), produced in E. coli, using recombinant DNA technology, is identical to the 34 N-terminal amino acid sequence of endogenous human parathyroid hormone.
Maltese: *Teriparatide, rhPTH(1-34), magħmul f'E. coli, permezz tat-teknoloġija rikombinanti tad-DNA, huwa identiku għas-sekwenza ta' 34 N-terminal amino acid ta' l-ormon uman paratirodje endoġenu.
English: България ТП "Ели Лили Недерланд" Б.В.
Maltese: България ТП "Ели Лили Недерланд" Б.В. - България
English: • Unexplained elevations of alkaline phosphatase
Maltese: • Livelli għoljin mhux spjegati ta' alkaline phosphatase
English: België/Belgique/Belgien Eli Lilly Benelux S.A./N.V.
Maltese: België/Belgique/Belgien Eli Lilly Benelux S.A.
English: New vertebral fracture (≥1) a
Maltese: Ksur ġdid vertebrali(≥1) a
English: FORSTEO has been evaluated in pharmacodynamic interaction studies with hydrochlorothiazide.
Maltese: FORSTEO ġie evalwat fi studji ta' interazzjoni farmakodinamika ma' hydrochlorothiazide.
English: • loss of energy
Maltese: • nuqqas ta' enerġija
English: * Needles not included.
Maltese: * Labar mhux inklużi.
English: Uncommon: Emphysema
Maltese: Mhux komuni: Emfisema
English: The following convention has been used for the classification of the adverse reactions: very common (≥ 1/10), common (≥ 1/100 to <1/10), uncommon (≥ 1/1,000 to <1/100), rare (≥ 1/10,000 to <1/1,000) very rare (<1/10,000).
Maltese: Bħala klassifikazzjoni tar reazzjonijiet avversi ġiet użata s-sistema li ġejja: komuni ħafna (≥ 1/10), komuni (≥ 1/100 sa < 1/10), mhux komuni (≥ 1/1,000 sa < 1/100), rari(≥ 1/10,000 sa < 1/1,000), rari ħafna (< 1/10,000),
English: Date of the latest renewal: 13 February 2013
Maltese: Data tal-aħħar tiġdid: 13 ta' Frar 2013
English: • reduced kidney function, including renal failure
Maltese: • tnaqqis fil-funzjoni tal-kliewi, inkluża l-insuffiċjenza renali
English: • Severe renal impairment
Maltese: • Indeboliment renali serju
English: Papendorpseweg 83, 3528 BJ Utrecht
Maltese: Papendorpseweg 83, 3528 BJ Utrecht L-Olanda.
English: Your pen contains 28 days of medicine.
Maltese: Il-pinna tiegħek fiha medikazzjoni għal 28 ġurnata.
English: Glacial acetic acid, sodium acetate (anhydrous), mannitol, metacresol, water for injections.
Maltese: Glacial acetic acid, sodium acetate (anhydrous), mannitol, metacresol, ilma għall-injezzjonijiet.
English: Chemical, physical and microbiological in-use stability has been demonstrated for 28 days at 2-8°C.
Maltese: Stabilita' kimika, fiżika u mikrobioloġika waqt l-użu ntweriet għal 28 jum f' temperatura ta' bejn 2 u 8°C.
English: Troubleshooting, Problem E.
Maltese: Jekk ma tistax tiġbed il-buttuna s-sewda ta' linjezzjoni ara Problemi li jista' jkollok, Problema E.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 10 June 2003
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 10 ta' Ġunju 2003
English: 2.4 mL solution in cartridge (siliconised Type I glass) with a plunger (halobutyl rubber), disc seal (polyisoprene/bromobutyl rubber laminate)/aluminium assembled into a disposable pen.
Maltese: 2.4 mL ta' soluzzjoni f' stoċċ (ħġieġ silikoniżżat tat-Tip I) bi planġer (halobutyl rubber), siġill filforma ta' diska (polyisoprene/bromobutyl rubber laminate)/aluminium magħqudin f' pinna li tintrema wara li tintuża.
English: The pivotal study included 1637 postmenopausal women (mean age 69.5 years).
Maltese: L-istudju prinċipali inkluda 1637 mara wara l-menopawża (eta' medja 69.5 sena).
English: Lilly France S.A.S., rue du colonel Lilly, 67640 Fegersheim, France
Maltese: Lilly France S.A.S., rue du colonel Lilly, 67640
English: The volume of distribution is approximately 1.7 L/kg.
Maltese: Distribuzzjoni Il-volum tad-distribuzzjoni huwa madwar 1.7 L/kg.
English: FORSTEO increases serum uric acid concentrations.
Maltese: FORSTEO jżid il-konċentrazzjonijiet ta' uric acid fis-serum.
English: Each pen contains 28 doses of 20 micrograms (per 80 microliters).
Maltese: Kull pinna fiha 28 doża ta' 20 mikrogramma (għal kull 80 mikrolitru).
English: Patients must be trained to use the proper injection techniques (see section 6.6).
Maltese: Il-pazjenti għandhom jiġu mħarrġa biex jużaw it-teknika korretta ta' injezzjoni (ara sezzjoni 6.6).
English: Manufacturer Lilly France S.A.S, Rue du Colonel Lilly, F-67640 Fegersheim, France.
Maltese: Lilly France S.A.S, Rue du Colonel Lilly, F-67640
English: Major non-vertebral fragility fracturesc (hip, radius, humerus, ribs and pelvis)
Maltese: Ksur ta' fraġilità maġġuri mhux vertebrali c(ġenbejn, radjus, omeru, kustilji u pelvis)
English: FORSTEO has been administered in single doses of up to 100 micrograms and in repeated doses of up to 60 micrograms/day for 6 weeks.
Maltese: FORSTEO ngħata f' dożi waħedhom sa 100 mikrogramma u f' dożi ripetuti sa 60 mikrogramma/jum għal 6 ġimgħat.
English: All patients were offered 1000 mg calcium per day and 800 IU vitamin D per day.
Maltese: 1000 mg ta' calcium kuljum u 800 UI ta' vitamina D kuljum.
English: b p≤0.001 compared with placebo c A significant reduction in the incidence of hip fractures has not been demonstrated d p≤0.025 compared with placebo.
Maltese: b p≤0.001 meta mqabbel mal-plaċebo c p≤0.025 meta mqabbel mal-plaċebo
English: Subcutaneous use
Maltese: Użu subkutanju
English: For those subjects who had baseline and follow-up spine radiographs, the incidence of new vertebral fractures was 28/516 (5.4%) in Forsteo- and 64/533 (12.0%) in risedronate-treated patients, relative risk (95% CI) = 0.44 (0.29-0.68), P<0.0001.
Maltese: Għall-dawk l-individwi li kellhom radjugrafs tas-sinsla tal-linja bażi u tas-segwitu, linċidenza ta' ksur vertebrali ġdid kienet 28/516 (5.4%) fil-pazjenti ttrattati b'Forsteo u 64/533 (12.0%) fil-pazjenti ttrattati b'risedronate, riskju relattiv (95% CI) = 0.44 (0.29-0.68), P<0.0001.
English: In a large clinical trial, antibodies that cross-reacted with teriparatide were detected in 2.8 % of women receiving FORSTEO.
Maltese: F' prova klinika kbira, l-antikorpi li ġew cross-reacted ma' teriparatide instabu f' 2.8% tan-nisa li ngħataw FORSTEO.
English: Phadisco Ltd
Maltese: Charles de Giorgio Ltd.