FrancophonIA/ELRC3.0 huggingface dataset:
English: Reduced heart rate and temporary AV-block can be seen after administration of dexmedetomidine.
Maltese: Tnaqqis fir-rata ta' taħbit tal-qalb u AV-block temporanju jidhru wara amministrazzjoni ta' dexmedetomidine.
English: Colourless Type I glass vials of 5 ml, 10 ml and 20 ml closed with a coated bromobutyl rubber stopper and aluminium cap in a carton box.
Maltese: Kunjetti ta' 5 ml,10 ml u 20 ml tal-ħġieġ mingħajr kulur tat-Tip I magħluqin b'tapp tal-klorobutil jew tal-bromobutil u għatu tal-aluminjum ġo kaxxa tal-kartun.
English: Dogs: After an intramuscular dose of 50 micrograms/kg a maximum concentration in plasma of about 12 nanograms/ml is reached after 0.6 hours.
Maltese: Wara doża fil-muskolu ta' 50 mikrogrammi/kg, l-ogħla konċentrazzjoni fil-plażma, ta' madwar 12-il nanogramma/ml tintlaħaq wara 0.6 ta' siegħa.
English: The expected sedative and analgesic effects are reached within 15 minutes after administration and are maintained up to 60 minutes after administration.
Maltese: L-effetti mistennija ta' rqad u serħan mill-uġiġħ jintlaħqu fi żmien 15-il minuta mill-amministrazzjoni u jibqgħu sa 60 minuta wara l-amministrazzjoni.
English: Date of first authorisation:13/12/2016 <Date of last renewal:> <{DD/MM/YYYY}> <{DD month YYYY}.>
Maltese: Data tal-ewwel awtorizzazzjoni:13/12/2016
English: mbH Ostlandring 13, 31303 Burgdorf Deutschland
Maltese: CP-Pharma Handelsges. mbH Ostlandring 13, 31303 Burgdorf Deutschland
English: In a clinical study, dexmedetomidine contributed to postoperative analgesia for 0.5 - 4 hours.
Maltese: Fi studju kliniku dexmedetomidine wassal għal serħan mill-uġiġħ għal 0.5 - 4 sigħat.
English: CP-Pharma Handelsges.
Maltese: CP-Pharma Handelsgesellschaft mbH
English: Metabolites are excreted mainly in the urine and to a lesser extent in the faeces.
Maltese: Il metaboliti jiġu eliminati l-aktar fl-urina u xi ftit anqas fl-ippurgar.
English: Dexmedetomidine is a potent and selective α2-adrenoceptor agonist that inhibits the release of noradrenaline from noradrenergic neurons.
Maltese: Dexmedetomidine huwa α2-adrenoceptor agonist qawwi u selettiv li jimblokka l-ħruġ ta' noradrenalina minn newroni noradrenerġiċi.
English: Cepedex contains dexmedetomidine as the active substance, which produces sedation and analgesia in dogs and cats.
Maltese: Cepedex fih dexmedetomidine bħala sustanza attiva, li traqqad u sserraħ mill-uġiġħ fil-klieb u l-qtates.
English: Dogs:
Maltese: Ingredjenti:
English: 5.2 Pharmacokinetic particulars
Maltese: .2 Tagħrif farmakokinetiċi
English: Methyl parahydroxybenzoate (E 218) Propyl parahydroxybenzoate
Maltese: fittex parir mediku minnufih u uri l-fuljett ta' tagħrif li hemm fil-pakkett lit-tabib imma SSUQX
English: Sedation may be reversed with atipamezole (see section 12 overdose).
Maltese: L-irqad jista' jiġi mreġġa' lura b'atipamezole (ara sezzjoni 12 Doża eċċessiva).
English: Anaesthesia can be induced 10 minutes after premedication by intramuscular administration of a target dose of 5 mg ketamine/ kg bw or by intravenous administration of propofol to effect.
Maltese: L-anestesija tista' tinbeda 10 minuti wara l-premedikazzjoni b'doża ta' 5 mg ketamina /kg piż fil muskolu jew b'amministrazzjoni ta' propofol fil-vina skont l-effett.
English: Dexmedetomidine, butorphanol and/or ketamine can be mixed in the same syringe as they have been shown to be pharmaceutically compatible.
Maltese: Dexmedetomidine, butorphanol u/jew ketamine jistgħu jitħalltu fl-istess siringa minħabba li ntwerew li huma farmakoloġikament kompatibbli.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Glass vials of 5, 10 or 20 ml (0.5 mg/ml)
Maltese: Kunjetti tal-ħġieġ ta' 5, 10 jew 20 ml (0.5 mg/ml)
English: STATEMENT OF ACTIVE SUBSTANCES
Maltese: TAS-SUSTANZA ATTIVA / SUSTANZI ATTIVI
English: In cases of overdose, or if the effects of dexmedetomidine become potentially life-threatening, the appropriate antagonist is atipamezole, administered by intramuscular injection, at the following dose: 5 times the initial dose dexmedetomidine in micrograms/kg bw.
Maltese: F'każi ta' doża eċċessiva, jew fejn l-effetti ta' dexmedetomidine jistgħu jkunu ta' theddida għall-ħajja, l antagonista xieraq huwa atipamezole, amministrat b'injezzjoni fil-muskolu bid-doża kif ġej: 5 darbiet aktar mid-doża inizjali ta' dexmedetomidine f'mikrogrammi/kg piż.
English: In cases of overdose, or if the effects of dexmedetomidine become potentially life- threatening, the appropriate dose of atipamezole is 10 times the initial dose of dexmedetomidine (micrograms/ kg bw or micrograms/ square meter body surface area).
Maltese: F'każijiet ta' doża eċċessiva, jew fejn l-effetti ta' dexmedetomidine jistgħu jkunu ta' theddida għallħajja, id-doża xierqa ta' atipamezole hija 10 darbiet aktar mid-doża inizjali ta' dexmedetomidine (mikrogrammi/ kg piż jew mikrogrammi/ metru kwadru tal-wiċċ tal-ġisem).
English: Dexmedetomidine 300 micrograms/m2 intramuscularly
Maltese: Dexmedetomidine 300 mikrogrammi/m2 fil-muskolu
English: Intramuscularly: up to 500 micrograms/square metre body surface area
Maltese: Fil-vina: sa 375 mikrogrammi/metru kwadru tal-wiċċ tal-ġisem Fil-muskolu: sa 500 mikrogrammi/metru kwadru tal-wiċċ tal-ġisem
English: The dose volume of atipamezole at the concentration of 5 mg/ml is one-tenth (1/10) the volume of Cepedex 0.1 mg/ml that was given to the cat.
Maltese: Il-volum tad-doża ta' atipamezole fil-konċentrazzjoni ta' 5 mg/ml huwa wieħed minn kull għaxra (1/10) mill-volum ta' Cepedex 0.1 mg/ml li ngħata lill-qattus.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard box (0.5 mg/ml)
Maltese: Kaxxa tal-kartun (0.5 mg/ml)
English: The dose for cats is 40 micrograms dexmedetomidine hydrochloride/kg bw equal to a dose volume of 0.08 ml Cepedex/kg bw when used for non-invasive, mildly to moderately painful procedures requiring restraint, sedation and analgesia.
Maltese: Id-doża għall-qtates hija ta' 40 mikrogramma dexmedetomidine hydrochloride /kg piż li huma daqs volum ta' doża ta' 0.08 ml Cepedex/kg piż meta jintuża għal proċeduri u eżaminazzjonijiet minn barra, li jikkawżaw ftit uġiġħ jew uġiġħ moderat fejn ikun hemm bżonn li trażżan, traqqad u sserraħ milluġiġħ.
English: The dose volume of atipamezole at the concentration of 5 mg/ml is one-half (1/2) the volume of Cepedex 0.5 mg/ml that was given to the cat.
Maltese: atipamezole fil-konċentrazzjoni ta' 5 mg/ml huwa nofs (1/2) il-volum ta' Cepedex 0.5 mg/ml li ngħata lill-qattus.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Glass vials of 5 or 10 ml (0.1 mg/ml)
Maltese: Kunjetti tal-ħġieġ ta' 5 jew 10 ml (0.1 mg/ml)
English: For higher weight ranges, use Cepedex 0.5 mg/ml and its dosing tables.
Maltese: Għal piżijiet ogħla, uża Cepedex 0.5 mg/ml u t-tabelli ta' dożaġġ tiegħu.
English: The dose volume of atipamezole at the concentration of 5 mg/ml equals the dose volume of Cepedex 0.5 mg/ml that was given to the dog, regardless of route of administration of Cepedex.
Maltese: Il-volum ta' doża ta' atipamezole b'konċentrazzjoni ta' 5 mg/ml huwa daqs il-volum ta' doża ta' Cepedex 0.5 mg/ml li ngħata lill-kelb, ikun xi jkun il-mod ta' amministrazzjoni ta' Cepedex.
English: A dose of 10 mg ketamine/ kg used concurrently with 40 micrograms dexmedetomidine/ kg may cause tachycardia.
Maltese: Doża ta' 10 mg ketamina /kg flimkien ma' 40 mikrogrammi dexmedetomidine /kg tista' twassal biex ilqalb tħabbat b'rata mgħaġġla.
English: In clinical trials the incidence of hypoxaemia was common, especially within the 15 first minutes into dexmedetomidine-ketamine anaesthesia.
Maltese: Fi studji kliniċi kienu ta' spiss il-każi ta' nuqqas ta' ossiġnu fid-demm b'mod speċjali fl-ewwel 15-il minuta ta' anestesija b'dexmedetomidine u ketamina.
English: The dose for cats is 40 micrograms dexmedetomidine hydrochloride/kg bw equal to a dose volume of 0.4 ml Cepedex/kg bw when used for non-invasive, mildly to moderately painful procedures requiring restraint, sedation and analgesia.
Maltese: Id-doża għall-qtates hija ta' 40 mikrogrammi dexmedetomidine hydrochloride /kg piż li huma daqs volum ta' doża ta' 0.4 ml Cepedex /kg piż meta jintuża għal proċeduri u eżaminazzjonijiet minn barra, li jikkawżaw ftit uġiġħ jew uġiġħ moderat fejn ikun hemm bżonn li trażżan, traqqad u sserraħ mill-uġiġħ.
English: Brady- and tachyarrhythmias have been reported and include profound sinus bradycardia, 1st and 2nd degree AV block and sinus arrest.
Maltese: Taħbit tal-qalb bil-mod jew mgħaġġel ġew irrapportati u jinkludu sinus bradycardia fil fond, AV block tal-ewwel u tat-tieni grad u waqfien tas-sinus.
English: Once broached use by:
Maltese: Out of scope change:
English: Major biotransformations in the dog include hydroxylation, glucuronic acid conjugation and Nmethylation in the liver.
Maltese: Bijotrasformazzjonijiet maġġuri fil-kelb jinkludu idrossilazzjoni, konjugazzjoni mal-aċidu glukoroniku u N-methylation fil-fwied.
English: Cats: After administration of 40 micrograms dexmedetomidine/kg bw intramuscularly concurrently with 5 mg ketamine/kg bw to cats, the maximum concentration of dexmedetomidine increased twofold but there was no effect on Tmax.
Maltese: Wara amministrazzjoni ta' 40 mikrogrammi dexmedetomidine /kg piż fil-muskolu flimkien ma' 5 mg ketamina /kg piż fil-qtates, l-ogħla konċentrazzjoni ta' dexmedetomidine żdiedet b'darbtejn imma ma kienx hemm effett fuq Tmax.
English: The dose volume of atipamezole at the concentration of 5 mg/ml is one-half the volume of Cepedex 0.5 mg/ml that was given to the cat.
Maltese: atipamezole fil-konċentrazzjoni ta' 5 mg/ml huwa nofs il-volum ta' Cepedex 0.5 mg/ml li ngħata lill qattus.
English: Care should be taken to avoid self-injection.
Maltese: Għandha tingħata attenzjoni sabiex tiġi evitata injezzjoni fuqek stess.
English: - Dogs: intravenous or intramuscular use - Cats: intramuscular use
Maltese: - Klieb: injezzjoni fil-vina jew fil-muskolu - Qtates: injezzjoni fil-muskolu
English: When dexmedetomidine is used as a premedicant in cats, vomiting, retching, pale mucous membranes, and low body temperature may occur.
Maltese: Meta ntuża b'dan il-mod, ġew irrapportati każi ta' remettar, temperatura baxxa u nervożiżmu.
English: Dogs: Dexmedetomidine doses are based on body surface area:
Maltese: Il-frekwenza ta' effetti mhux mixtieqa hija definita skont din il-konvenzjoni:
English: These may include profound sinus bradycardia, 1st and 2nd degree AV block, sinus arrest or pause, as well as atrial, supraventricular and ventricular premature complexes.
Maltese: Dawn jistgħu jinkludu sinus bradycardia fil-fond, AV block tal-ewwel u tat-tieni grad, pawsa jew waqfien tas-sinus kif ukoll kumplessi prematuri atrijali, supraventrikulari u ventrikulari.
English: All known metabolites lack pharmacological activity.
Maltese: Il-metaboliti kollha magħrufa m'għandhomx attività farmakoloġika.
English: Dexmedetomidine also induces a number of other α2-adrenoceptor mediated effects, which include piloerection, depression of motor and secretory functions of the gastrointestinal tract, diuresis and hyperglycaemia.
Maltese: Dawn jinkludu twaqqif tal-pil, tnaqqis fil-moviment u tnixxijiet tas-sistema gastro-intestinali, żieda fil-produzzjoni tal-urina u żieda fil-livell ta' zokkor fiddemm.
English: By virtue of its α2-adrenergic activity, dexmedetomidine causes a decrease in heart rate and body temperature.
Maltese: darbiet aktar mid-doża inizjali ta' dexmedetomidine f'mikrogrammi/kg piż.
English: a) Skeletal Effects
Maltese: a) Effetti skeletrali
English: Date of first authorisation: 5 August 1998 Date of latest renewal: 11 August 2008
Maltese: Data ta' l-ewwel awtorizzazzjoni: 5 Awwissu 1998 Data ta' l-aħħar tiġdid: 11 ta' Awwissu 2008
English: Renal impairment:
Maltese: Indeboliment renali:
English: Tablet coating: Titanium dioxide (E 171), polysorbate 80, hypromellose, macrogol 400, carnauba wax.
Maltese: Titanium dioxide (E171), polysorbate 80, hypromellose, macrogol 400, carnauba wax
English: Anhydrous lactose Lactose monohydrate Crospovidone
Maltese: Anhydrous lactose Lactose monohydrate Crospovidone Magnesium stearate
English: 3528 BJ Utrecht The Netherlands
Maltese: 3528 BJ Utrecht
English: Raloxifene is strongly bound to plasma proteins (98-99 %).
Maltese: Raloxifene jintrabat sew mal-proteini tal-plażma (98 sa 99%).
English: It may harm them,
Maltese: Povidone,
English: Optruma contains lactose.
Maltese: Optruma fih lactose.
English: Tablet Core: Povidone, polysorbate 80, anhydrous lactose, lactose monohydrate, crospovidone, magnesium stearate.
Maltese: Povidone, polysorbate 80, anhydrous lactose, lactose monohydrate, crospovidone, magnesium stearate
English: b) Effects on lipid metabolism and cardiovascular risk
Maltese: b) Effetti fuq il-metaboliżmu tal-lipidi u r-riskju kardjovaskulari
English: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands
Maltese: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, L-Olanda
English: Ink: Shellac, propylene glycol, indigo carmine (E 132).
Maltese: Shellac, propylene glycol, indigo carmine (E132).
English: Very common: Flu syndrome Common: Peripheral oedema
Maltese: Komuni ħafna : Sindromu ta' l-influwenza Komuni : Edema periferali
English: Each tablet contains lactose (149.40 mg).
Maltese: Kull pillola fiha lactose (149.40 mg)
English: There is no evidence of endometrial proliferation.
Maltese: M'hemmx evidenza ta' proliferazjoni ta' l-endometriju.
English: Hepatic impairment including cholestasis.
Maltese: Indeboliment epatiku inkluża kolestażi.
English: • Flu syndrome
Maltese: • Sindromu tal-influwenza
English: (listed in section 6).
Maltese: (ara sezzjoni 5.3).
English: България ТП "Ели Лили Недерланд" Б.В.
Maltese: България ТП "Ели Лили Недерланд" Б.В. - България тел.
English: Raloxifene undergoes extensive first pass metabolism to the glucuronide conjugates: raloxifene-4'glucuronide, raloxifene-6-glucuronide, and raloxifene-6, 4′-diglucuronide.
Maltese: Permezz ta' metaboliżmu first pass, Raloxifene jinbidel estensivament f'derivattivi glukuronidi: raloxifene-41-glucuronide, raloxifene-6-glucuronide u raloxifene-6,41-diglucuronide.
English: iii) Calcium kinetics.
Maltese: iii) Il-kinetiċi tal-calcium.
English: 4.6 Fertility, pregnancy and lactation
Maltese: .6 Fertilitá, tqala u treddigħ Tqala
English: Absolute bioavailability of raloxifene is 2 %.
Maltese: Il-bijodisponibbiltà assoluta ta' raloxifene hija ta' 2%.
English: Eli Lilly Nederland B.V. Tel: + 31-(0) 30 60 25 800
Maltese: Eli Lilly Nederland B.V. Tel: + 31-(0) 30 60 25 800 Norge
English: INFORMATION IN BRAILLE
Maltese: INFORMAZZJONI BIL-BRAILLE Optruma
English: Musculoskeletal and connective tissue disorders
Maltese: Disturbi muskolu-skeletali u tat-tessuti konnettivi
English: • Hot flushes (vasodilatation)
Maltese: • Fwawar (vażodilatazzjoni)
English: Optruma reduced the incidence of clinical vertebral fractures by 35% compared with placebo (HR 0.65, CI 0.47
Maltese: Optruma naqqset l-inċidenza ta' ksur kliniku tal-vertebri b'35% meta mqabbla ma' plaċebo (HR 0.65, CL 0.47
English: Optruma contains the active substance raloxifene hydrochloride.
Maltese: Optruma fiha is-sustanza attiva raloxifene hydrochloride.
English: e) Effects on cognitive function
Maltese: e) Effetti fuq il-funzjoni konjittiva
English: de la Industria 30, 28108 Alcobendas (Madrid), Spain.
Maltese: Manifattur - Lilly S.A., Avda. de la Industria 30, 28108 Alcobendas (Madrid), Spanja
English: • Increased risk of blood clots in the lungs (pulmonary embolism)
Maltese: • Riskju ogħla ta' koaguli tad-demm fil-pulmuni ( emboliżmu pulmonari)
English: UNIQUE IDENTIFIER - 2D BARCODE
Maltese: IDENTIFIKATUR UNIKU - BARCODE 2D <barcode 2D li jkollu l-identifikatur uniku inkluż.>
English: (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000),
Maltese: Ġiet użata s-sistema li ġejja bħala klassifikazzjoni tar-reazzjonijiet avversi: komuni ħafna (≥ 1/10), komuni (≥ 1/100, <1/10), mhux komuni (>1/1,000, <1/100), rari (>1/10,000, <1/1,000), rari ħafna
English: Ink:
Maltese: SN:
English: Optruma tablets are packed either in PVC/PE/PCTFE blisters or in high density polyethylene bottles.
Maltese: Il-pilloli ta' Optruma jiġu fil-folji ta' PVC/PE/PCTFE jew fil-fliexken tal-polyethylene ta' densità għolja.
English: EU/1/98/074/001 14 film coated tablets EU/1/98/074/002 28 film coated tablets EU/1/98/074/003 84 film coated tablets
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/98/074/001 14-il pillola miksija b'rita EU/1/98/074/002 28 pillola miksija b'rita EU/1/98/074/003 84 pillola miksija b'rita
English: Approximately 60 % of an oral dose is absorbed.
Maltese: Madwar 60% ta' doża orali tiġi assorbita.
English: In the 4th year alone, Optruma reduced the new vertebral fracture risk by 39 % (RR 0.61, CI 0.43, 0.88).
Maltese: Fir-raba' sena biss, Optruma naqqset ir-riskju ta' ksur ġdid tal-vertebri b'39% (RR 0.61, CI 0.43, 0.88).
English: Tel: + 43-(0) 1 711 780
Maltese: Tel: + 43-(0) 1 711 780 Polska
English: Cholecystectomy rates for raloxifene (2.3 %) were not statistically significantly different from placebo (2.0 %).
Maltese: Ir-rati ta' koleċistektomija għal raloxefine (2.3%) ma kienux differenti b'mod statistikament sinifikanti minn dawk ta' plaċebo (2.0%)
English: Optruma (n = 317) was compared with continuous combined (n = 110) hormone replacement therapy (HRT) or cyclic (n = 205) HRT patients in some clinical trials.
Maltese: Optruma (n=317) kienet imqabbla ma' terapija kontinwa (n=110) ta' sostituzzjoni bl-ormoni (HRT)
English: Another adverse reaction observed was leg cramps (5.5 % for Optruma, 1.9 % for placebo in the prevention population and 9.2 % for Optruma, 6.0 % for placebo in the treatment population).
Maltese: Reazzjoni avversa oħra kienu l-bugħawwiġijiet fir-riġlejn (5.5% għal Optruma, 1.9% għall-plaċebo filgrupp tal-prevenzjoni u 9.2% għal Optruma, 6.0% għall-plaċebo fil-grupp tal-kura).
English: Eli Lilly Benelux S.A./N.V.
Maltese: België/Belgique/Belgien Eli Lilly Benelux S.A./N.V. Tél/Tel:
English: Clinical trials showed that a 60 mg daily dose of Optruma significantly decreased total cholesterol (3 to 6 %), and LDL cholesterol (4 to 10 %).
Maltese: Provi kliniċi wrew li t-teħid ta' doża ta' Optruma f'doża ta' 60 mg kuljum ta' naqqset b'mod sinifikanti il-kolesterol totali (b'3 sa 6%) u l-kolesterol LDL (b'4 sa 10%).
English: Blister boxes contain 14, 28, or 84 tablets.
Maltese: Il-kaxex tal-folji fihom 14, 28 jew 84 pilloli.
English: BOTTLE LABEL, BOTTLE CARTON:
Maltese: TIKKETTA TAL-FLIXKUN, KARTUNA TAL-FLIXKUN:
English: In some clinical trials, daily doses were given up to 600 mg for 8 weeks and 120 mg, for 3 years.
Maltese: F'xi studji kliniċi, ġew mogħtija dożi sa 600 mg kuljum għal 8 ġimgħat u 120 mg għal 3 snin.
English: Phadisco Ltd Τηλ: +357 22 715000
Maltese: Τηλ: +357 22 715000
English: • If you are receiving oral oestrogen therapy.
Maltese: • Jekk qiegħda tirċievi terapija ta' estroġeni orali.
English: In vitro, raloxifene did not interact with the binding of warfarin, phenytoin, or tamoxifen.
Maltese: Raloxifene in vitro ma weriex interazzjoni ma' l-irbit ta' warfarin, phenytoin jew tamoxifen.
English: The hazard ratio for all VTE events in the RUTH study was HR = 1.44 (1.06 - 1.95).
Maltese: Ir riskju ta' komplikazzjonijiet għal każijiet kollha ta' VTE fl-istudju RUTH kien ta' HR= 1.44, (1.06
English: Optruma treatment for 4 years reduced the incidence of vertebral fractures by 46 % (RR 0.54, CI 0.38, 0.75) and 32 % (RR 0.68, CI 0.56, 0.83) in patients with osteoporosis or osteoporosis with an existing fracture respectively.
Maltese: Il-kura b'Optruma għal 4 snin tnaqqas l-inċidenza ta' ksur tal-vertebri b'46% (RR 0.54, CI 0.38, 0.75) u 32% (RR 0.68, CI 0.56, 0.83) f'pazjenti bl-osteoporożi jew l-osteoporożi bi ksur eżistenti, rispettivament.
English: Severe renal impairment.
Maltese: Indeboliment renali sever.
English: Flu syndrome was reported by 16.2 % of Optruma treated patients and 14.0 % of placebo treated patients.
Maltese: Is-sindromu ta' l-influwenza kien irrapportat f'16.2% f'dawk ittrattati bl-Optruma u 14% ta' dawk ilpazjenti ittrattati bil-plaċebo.
English: Elliptically shaped, white tablets imprinted with the code '4165'.
Maltese: Pilloli bojod ovali bil-kodiċi ‘4165' stampat fuqhom.
English: The highest overdose has been approximately 1.5 grams.
Maltese: L-ogħla doża eċċessiva kienet ta' madwar 1.5 grammi.
English: OPTRUMA 60 mg film coated tablets raloxifene hydrochloride
Maltese: Optruma 60 mg pilloli miksija b'rita raloxifene hydrochloride
English: In the RUTH study overall clinical fractures were collected as a secondary endpoint.
Maltese: Fl-istudju kliniku RUTH, il-ksur kliniku kollu kien miġbur bħala riżultat finali sekondarju.
English: Hepatic impairment: Optruma should not be used in patients with hepatic impairment (see section 4.3 and 4.4).
Maltese: Optruma m'għandhiex tintuża f'indeboliment epatiku (ara sezzjonijiet 4.3 u 4.4).
English: In a study of 7,705 postmenopausal women with a mean age of 66 years and with osteoporosis or osteoporosis with an existing fracture, Optruma treatment for 3 years reduced the incidence of vertebral fractures by 47 % (RR 0.53, CI 0.35, 0.79; p < 0.001) and 31 % (RR 0.69, CI 0.56, 0.86; p < 0.001) respectively.
Maltese: Fi studju fuq 7,705 nisa wara l-menopawsa ta' età medja ta' 66 sena li għandhom l-osteoporożi jew l-osteoporożi bi ksur eżistenti, il-kura b'Optruma għal 3 snin naqqset l inċidenza ta' ksur tal-vertebri b'47% (RR 0.53, CI 0.35 0.79; p < 0.001) u 31% (RR 0.69, CI 0.56,
English: Gastrointestinal disorders
Maltese: Distrubi gastro-intestinali
English: The relative risk of venous thromboembolic events observed during raloxifene treatment was 1.60 (CI 0.95, 2.71) when compared to placebo, and was 1.0 (CI 0.3, 6.2) when compared to oestrogen or hormonal replacement therapy.
Maltese: Ir-riskju relattiv ta' avvenimenti tromboembolitiċi fil-vini osservati waqt il-kura b'raloxifene kien 1.60 (CI 0.95, 2.71) meta mqabbel ma' dak tal-plaċebo u kien 1.0 (CI 0.3, 6.2) meta mqabbel mat-terapija bl-estroġenu jew mat-terapija ta' sostituzzjoni ta' l-ormoni.
English: After 3 years of treatment, at least a 5 mm increase in endometrial thickness, assessed with transvaginal ultrasound, was observed in 1.9 % of the 211 women treated with raloxifene 60 mg/day compared to 1.8 % of the 219 women who received placebo.
Maltese: Wara 3 snin ta' kura, mhux inqas minn 5 mm żieda fil-ħxuna ta' l-endometriju, kif assessjat bl-ultrasawnd transvaġinali, kien osservat f'1.9% ta' 211-il mara, ikkurati b'60 mg raloxifene kuljum meta mqabbla ma' 1.8% ta' 219-il mara li rċevew il-plaċebo.
English: • Swelling of hands, feet and legs (peripheral oedema)
Maltese: • Nefħa ta' l-idejn, tas-saqajn u tar-riġlejn (edima periferali)
English: Three trials included 1,764 postmenopausal women who were treated with Optruma and calcium or calcium supplemented placebo.
Maltese: Tliet provi inkludew 1,764 mara wara l-menopawża li kienu ikkurati b'Optruma u calcium, jew il-plaċebo flimkien ma' calcium.
English: In rabbits, abortion and a low rate of ventricular septal defects (≥ 0.1 mg/kg) and hydrocephaly (≥ 10 mg/kg) were seen.
Maltese: Fil-fniek, l-abort u rata baxxa ta' difetti fis-septum li jifred il-ventrikoli tal-qalb (≥ 0.1 mg/kg), u l-idroċefalija (≥ 10 mg/kg) kienu innotati.
English: In contrast to the highly responsive ovaries in this rodent model, the human ovary after menopause is relatively unresponsive to reproductive hormonal stimulation.
Maltese: l-ovarja umana, wara l-menopawsa, ma tirrispondix relattivament għal stimuli ormonali riproduttivi.
English: Eli Lilly Slovakia s.r.o.
Maltese: Slovenská republika Eli Lilly Slovakia, s.r.o.
English: A relative risk of 1.60 (CI 0.95, 2.71) was observed in Optruma treated patients compared to placebo.
Maltese: Riskju relattiv ta' 1.60 (CI 0.95, 2.71) kien osservat fil-pazjenti ittrattati bl-Optruma meta mqabbla ma' dawk fuq il-plaċebo.