FrancophonIA/ELRC3.0 huggingface dataset:
English: Amenorrhoea, breast discharge, breast enlargement, gynaecomastia General disorders and administration site conditions Common
Maltese: Amenorreja, tnixxija mis-sider, tkabbir tas-sider, ginekomastija Disturbi ġenerali u kondizzjonijiet ta' mnejn jingħata Komuni
English: Pregabalin treatment can be started with a dose of 150 mg (7.5 ml) per day.
Maltese: Il-kura bi pregabalin tista' tinbeda b'doża ta' 150 mg (7.5 ml) kuljum.
English: The safety and efficacy of Lyrica in children below the age of 12 years and in adolescents (12-17 years of age) have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' Lyrica fit-tfal ta' taħt it-12 -il sena u l-adoloxxenti (12-17 -il sena) ma ġewx determinati s'issa.
English: Lyrica 25 mg hard capsules EU/1/04/279/001-005 EU/1/04/279/026
Maltese: Lyrica 25 mg kapsuli iebsin EU/1/04/279/001-005
English: Lyrica 25 mg hard capsules
Maltese: Lyrica 25 mg kapsuli iebsin
English: Lyrica 200 mg hard capsules Light orange, marked “Pfizer” on the cap and “PGN 200” on the body with black ink.
Maltese: Lyrica 200 mg kapsuli iebsin Oranġjo ċar, immarkata “Pfizer” fuq il-parti ta' fuq u “PGN 200” fuq il-parti ewlenija b'linka sewda.
English: Lyrica 100 mg hard capsules
Maltese: Lyrica 100 mg kapsuli iebsin
English: Lyrica 150 mg hard capsules
Maltese: Lyrica 150 mg kapsuli iebsin
English: In the postmarketing experience, there are reports of respiratory failure, coma and deaths in patients taking pregabalin and opioids and/or other central nervous system (CNS) depressant medicinal products.
Maltese: F' esperjenza ta' wara t-tqegħid fis-suq, kien hemm rapporti ta' insuffiċjenza respiratorja, koma u mwiet f' pazjenti li kienu qed jieħdu pregabalin u l-opjojdi u/jew prodotti mediċinali oħra dipressanti tas-sistema nervuża ċentrali (CNS).
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 06 July 2004
Maltese: Data tal-ewwel awtorizzazzjoni: 06 ta' Lulju 2004
English: 5.1 Pharmacodynamic properties Pharmacotherapeutic group: Anti-epileptics, other anti-epileptics ATC code: N03AX16
Maltese: Kura kontra l-epilessija, kura oħra kontra l-epilessija Kodiċi ATC:
English: Pregabalin has been studied in 3 controlled clinical trials of 12 week duration with BID or TID dosing.
Maltese: Pregabalin ġie studjat fi 3 provi kliniċi kkontrollati li damu 12-il ġimgħa fejn ingħataw dożi BID jew TID.
English: 14 hard capsules 21 hard capsules 56 hard capsules 84 hard capsules 100 hard capsules 100 x 1 hard capsules
Maltese: 14-il kapsula iebsa 21 kapsula iebsa 56 kapsula iebsa 84 kapsula iebsa 100 kapsula iebsa 100 x 1 kapsula iebsa
English: Each hard capsule also contains 24.75 mg lactose monohydrate.
Maltese: Lyrica 225 mg kapsuli iebsin Kull kapsula iebsa fiha ukoll 24.75 mg lactose monohydrate.
English: • Feeling of elation, confusion, disorientation, decrease in sexual interest, irritability.
Maltese: • Sensazzjoni ta' ferħ kbir, konfużjoni, diżorjentament, tnaqqis fl-interess sesswali, irritabilità
English: Carton of blister pack (14, 56 or 100) and perforated unit dose blister pack (100) for 225 mg hard capsules
Maltese: Kartuna tal-pakkett ta' folji (14, 56 jew 100) u pakkett ta' folji ta' doża waħda (100) perforat għal kapsuli iebsin ta' 225 mg
English: Hepatobiliary disorders Uncommon
Maltese: • Diffikultà biex tibla
English: Lyrica 75 mg hard capsules White and orange, marked “Pfizer” on the cap and “PGN 75” on the body with black ink.
Maltese: Lyrica 75 mg kapsuli iebsin Bajda u oranġjo, immarkata “Pfizer” fuq il-parti ta' fuq u “PGN 75” fuq il-parti ewlenija b'linka sewda.
English: • Flushing, hot flushes.
Maltese: • Fwawar, fwawar tal-menopawsa.
English: PVC/Aluminium blisters containing 14, 21, 56, 84, 100, or 112 hard capsules.
Maltese: Folji tal-PVC/Aluminju li fihom 14, 21, 56, 84, 100 jew 112 kapsula iebsa. 100 x 1 kapsula iebsa f'folji ta' doża waħda perforati tal-PVC/Aluminju.
English: Discharge the syringe contents into the mouth (Figure 7).
Maltese: Itfa' il-kontenuti tas-siringa ġol-ħalq (Figura 7).
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains 20 mg of pregabalin
Maltese: Kull ml fih 20 mg pregabalin
English: NAME OF THE MEDICINAL PRODUCT Lyrica 20 mg/ml oral solution
Maltese: Lyrica 20 mg / ml soluzzjoni orali
English: Each hard capsule contains 100 mg pregabalin.
Maltese: Kull kapsula iebsa fiha 100 mg ta' pregabalin.
English: 14 hard capsules 21 hard capsules 56 hard capsules 84 hard capsules 100 hard capsules 100 x 1 hard capsules 112 hard capsules
Maltese: 14-il kapsuli iebsin 21 kapsuli iebsin 56 kapsuli iebsin 84 kapsuli iebsin 100 kapsuli iebsin 100 x 1 kapsuli iebsin 112 kapsuli iebsin
English: 14 hard capsules 56 hard capsules 100 hard capsules 100 x 1 hard capsules 112 hard capsules
Maltese: 14-il kapsula iebsa 56 kapsula iebsa 100 kapsula iebsa 100 x 1 kapsula iebsa 112 kapsula iebsa
English: 14 hard capsules 56 hard capsules 100 hard capsules 100 x 1 hard capsules
Maltese: 14-il kapsula iebsa 56 kapsula iebsa 100 kapsula iebsa 100 x 1 kapsula iebsa
English: Bottle immediate packaging for 75 mg hard capsules - pack of 200
Maltese: Flixkun li jmiss mal-prodott għal kapsuli iebsin 75 mg kapsuli iebsin - pakkett ta' 200
English: Open bottle and at first use insert the Press-In Bottle Adapter (PIBA) (Figures 1 and 2).
Maltese: Iftaħ il-flixkun u meta tużah l-ewwel darba daħħal l-adapter ġol-flixkun (PIBA) (Figuri 1 u 2).
English: It is advised not to drink alcohol while taking Lyrica.
Maltese: Huwa rakkomandat li wieħed ma jixrobx alkoħol waqt li jkun qed jieħu Lyrica.
English: Hypersensitivity reactions
Maltese: Reazzjonijiet ta' sensittività
English: There are postmarketing reports of events related to reduced lower gastrointestinal tract function (e.g. intestinal obstruction, paralytic ileus, constipation) when pregabalin was co-administered with medications that have the potential to produce constipation, such as opioid analgesics.
Maltese: Tnaqqis fil-funzjoni gastrointestinali fil-parti t'isfel Kien hemm rapporti ta' episodji assoċjati mal-funzjoni gastrointestinali fil-parti t'isfel (eż. imblukkar tal-intestini, ileus paralitiku, stitikezza) fl-esperjenza ta' wara t-tqegħid fis-suq, meta pregabalin ġie mogħti flimkien ma' mediċini li għandhom potenzjal li jikkawżaw stitikezza, bhal analġesiċi opjojd.
English: Artificial strawberry flavour [contains small amounts of ethanol (alcohol)] Purified water
Maltese: Togħma tal-frawli artifiċjali [li fiha ammonti żgħar ta' ethanol (alcohol)] Ilma ppurifikat
English: Carton of blister pack (14, 21, 56, 84, 100, and 112) and perforated unit dose blister pack (100) for 25 mg hard capsules.
Maltese: Kartuna tal- pakket bil-folji (14, 21, 56,84, 100, u 112) u pakkett b'folji ta' doża waħda perforati (100) għal 25 mg kapsuli iebsa
English: Lyrica 225 mg hard capsules White and light orange marked “Pfizer” on the cap and “PGN 225” on the body with black ink.
Maltese: Kapsuli iebsin ta' lewn abjad u oranġjo ċar, bi “Pfizer” immarkata fuq ilparti ta' fuq u “PGN 225” fuq il-parti ewlenija.
English: Each hard capsule contains 50 mg pregabalin.
Maltese: Kull kapsula iebsa fiha 50 mg ta' pregabalin.
English: Gelatin
Maltese: Zaventem
English: • Lyrica has been associated with dizziness and somnolence, which could increase the occurrence of accidental injury (fall) in elderly patients.
Maltese: • Lyrica ġie assoċjat ma' sturdament u ngħas, li jistgħu jżidu l-okkorrenza ta' korriment aċċidentali (waqgħat) f'pazjenti anzjani.
English: • Hepatitis (inflammation of the liver).
Maltese: • Insuffiċjenza tal-fwied • Epatite (infjammazzjoni tal-fwied)
English: Bottle immediate packaging for 300 mg hard capsules - pack of 200
Maltese: Pakkett li jmiss mal-flixkun għal kapsuli iebsin ta' 300 mg - pakkett ta' 200
English: Lyrica 200 mg hard capsules Pregabalin
Maltese: Lyrica 200 mg kapsuli iebsin Pregabalin
English: Blister pack (14, 56 or 100) and perforated unit dose blister pack (100) for 225 mg hard capsules
Maltese: Pakkett ta' folji (14, 56 jew 100) u pakkett ta' folji ta' doża waħda (100) perforat għal kapsuli iebsin ta' 225 mg
English: Lyrica 100 mg hard capsules Pregabalin
Maltese: Lyrica 100 mg kapsuli iebsin Pregabalin
English: Posology The dose range is 150 to 600 mg (7.5 to 30 ml) per day given in either two or three divided doses.
Maltese: L-ammont ta' doża li jista' jittieħed hu bejn 150 u 600 mg (7.5 sa 30 ml) kuljum imqassmin f'żewġ dożi jew tlieta.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Maltese: Pazjenti bi problemi ereditarji serji ta' intolleranza għall-galattosju, ilLapp lactase deficiency jew assorbiment ħażin tal-glukosju-galattosju m'għandhomx jieħdu din ilmediċina.
English: Pregabalin Adverse Drug Reactions
Maltese: Reazzjonijiet avversi għall-mediċina
English: Bottle immediate packaging for 150 mg hard capsules - pack of 200
Maltese: Pakkett li jmiss mal-flixkun għal kapsuli iebsin ta' 150 mg - pakkett ta' 200
English: Lyrica 300 mg hard capsules Pregabalin
Maltese: Lyrica 300 mg kapsuli iebsin Pregabalin
English: PVC/Aluminium blisters containing 14, 21, 56, 84, or 100 hard capsules.
Maltese: Folji tal-PVC/Aluminju li fihom 14, 21, 56, 84, jew 100 kapsula iebsa. 100 x 1 kapsula iebsa f'folji ta' doża waħda perforati tal-PVC/Aluminju.
English: Blister pack (14, 21, 56, 84, 100, and 112) and perforated unit dose blister pack (100) for 25 mg hard capsules
Maltese: Pakkett ta' folji (14, 21, 56, 84, 100, u 112) u pakkett ta' folji ta' doża waħda (100) perforat għal kapsuli iebsin ta' 25 mg
English: PVC/Aluminium blisters containing 14, 56, 70 100, or 112 hard capsules.
Maltese: Folji tal-PVC/Aluminju li fihom 14, 56, 70, 100 jew 112 kapsula iebsa. 100 x 1 kapsula iebsa f'folji ta' doża waħda perforati tal-PVC/Aluminju.
English: How to take Lyrica
Maltese: Tiħux Lyrica:
English: • Swelling of the body including extremities.
Maltese: • Nefħa fil-ġisem, inkluż l-estremitajiet
English: PVC/Aluminium blisters containing 21, 84, or 100 hard capsules.
Maltese: Folji tal-PVC/Aluminju li fihom 21, 84, jew 100 kapsula iebsa. 100 x 1 kapsula iebsa f'folji ta' doża waħda perforati tal-PVC/Aluminju.
English: Lyrica 100 mg hard capsules Orange marked “Pfizer” on the cap and “PGN 100” on the body with black ink.
Maltese: Lyrica 100 mg kapsuli iebsin Oranġjo, immarkata “Pfizer” fuq il-parti ta' fuq u “PGN 100” fuq il-parti ewlenija b'linka sewda.
English: Carton of blister pack (21, 84 or 100) and perforated unit dose blister pack (100) for 200 mg hard capsules
Maltese: Kartuna tal-pakkett ta' folji (21, 84 jew 100) u pakkett ta' folji ta' doża waħda (100) perforat għal kapsuli iebsin ta' 200 mg
English: Blister pack (14, 56, 100 or 112) and perforated unit dose blister pack (100) for 150 mg hard capsules
Maltese: Kaxxa tal-pakkett ta' folji (14, 56, 100 u 112) u pakkett ta' folji ta' doża waħda (100) perforat għal kapsuli iebsin ta' 150 mg
English: Lyrica 150 mg hard capsules White marked “Pfizer” on the cap and “PGN 150” on the body with black ink.
Maltese: Lyrica 150 mg kapsuli iebsin Bajda, immarkata “Pfizer” fuq il-parti ta' fuq u “PGN 150” fuq il-parti ewlenija b'linka sewda.
English: Each hard capsule also contains 33 mg lactose monohydrate.
Maltese: Lyrica 300 mg kapsuli iebsin Kull kapsula iebsa fiha ukoll 33 mg lactose monohydrate.
English: Lyrica 150 mg hard capsules Pregabalin
Maltese: Lyrica 150 mg kapsuli iebsin Pregabalin
English: Each hard capsule also contains 8.25 mg lactose monohydrate.
Maltese: Lyrica 75 mg kapsuli iebsin Kull kapsula iebsa fiha ukoll 8.25 mg lactose monohydrate.
English: Blister pack (14, 56, 70, 100 or 112) and perforated unit dose blister pack (100) for 75 mg hard capsules
Maltese: Pakkett ta' folji (14, 21, 56, 70, 100 u 112) u pakkett ta' folji ta' doża waħda (100) perforat għal kapsuli iebsin ta' 75 mg
English: Carton of blister pack (21, 84 or 100) and perforated unit dose blister pack (100) for 100 mg hard capsules
Maltese: Kartuna tal-pakkett ta' folji (21 , 84 jew 100) u pakkett ta' folji ta' doża waħda (100) perforat għal kapsuli iebsin ta' 100 mg
English: White blood cell count decreased
Maltese: KONDIZZJONIJIET JEW RESTRIZZJONIJIET RIGWARD
English: • Change in perception of self, restlessness, depression, agitation, mood swings, difficulty finding words, hallucinations, abnormal dreams, panic attack, apathy, aggression, elevated mood, mental impairment, difficulty with thinking, increase in sexual interest, problems with sexual functioning including inability to achieve a sexual climax, delayed ejaculation.
Maltese: • Bidla fil-mod kif tħares lejk innifsek, irrekwitezza, depressjoni, aġitazzjoni, bidliet fil-burdata, diffikulta' biex issib il-kelma, alluċinazzjonijiet, ħolm anormali, attakk ta' paniku, apatija, agressjoni, burdata ta' entużjażmu, indeboliment mentali, diffikulta' biex taħseb, żieda flinteress sesswali, problemi fil-funzjoni ta' natura sesswali li jinkludu inkapaċità li tilħaq orgażmu, dewmien fl-ejakulazzjoni.
English: Lyrica 300 mg hard capsules White and orange, marked “Pfizer” on the cap and “PGN 300” on the body with black ink.
Maltese: Kapsuli iebsin ta' lewn abjad u oranġjo, bi “Pfizer” immarkata fuq il-parti ta' fuq u “PGN 300” fuq il-parti ewlenija.
English: White and orange hard capsules with “Pfizer” marked on the cap and “PGN 75” on the body.
Maltese: Kapsuli iebsin ta' lewn abjad u oranġjo, bi “Pfizer” immarkata fuq il-parti ta' fuq u “PGN 75” fuq il-parti ewlenija.
English: Take your box or bottle of Lyrica capsules with you.
Maltese: Ħu lkaxxa jew il-flixkun tal-kapsuli Lyrica miegħek.
English: Lyrica 225 mg hard capsules Pregabalin
Maltese: Lyrica 225 mg kapsuli iebsin Pregabalin
English: If you are an elderly patient (over 65 years of age), you should take Lyrica normally except if you have problems with your kidneys.
Maltese: Jekk int pazjent anzjan ('il fuq minn 65 sena), inti għandek tieħu Lyrica b'mod normali ħlief jekk ikollok problemi bil-kliewi.
English: Pregabalin plasma clearance and renal clearance are directly proportional to creatinine clearance (see section 5.2 Renal impairment).
Maltese: Pregabalin jiġi eliminat fil-ħalib tas-sider tal-bniedem (ara sezzjoni 5.2).
English: White hard capsules, with “Pfizer” marked on the cap and “PGN 150” on the body.
Maltese: Kapsuli iebsin ta' lewn abjad, bi “Pfizer” immarkata fuq il-parti ta' fuq u “PGN 150” fuq il-parti ewlenija.
English: • Fluid in the lungs.
Maltese: • Ilma fil-pulmun
English: Carton of blister pack (14, 21, 56, 84 and 100) and perforated unit dose blister pack (100) for 50 mg hard capsules
Maltese: Kartuna ta' pakkett ta' folji (14, 21, 56 , 84 u 100) u pakkett ta' folji ta' doża waħda (100) perforat għal kapsuli iebsin ta' 50 mg
English: MAH logo
Maltese: IL-PROVVISTA
English: Blister pack (14, 21, 56, 84 and 100) and perforated unit dose blister pack (100) for 50 mg hard capsules
Maltese: Pakkett ta' folji (14, 21, 56 , 84 u 100) u pakkett ta' folji ta' doża waħda (100) perforat għal kapsuli iebsin ta' 50 mg
English: Each hard capsule also contains 35 mg lactose monohydrate.
Maltese: Lyrica 25 mg kapsuli iebsin Kull kapsula iebsa fiha ukoll 35 mg lactose monohydrate.
English: Carton of blister pack (14, 56, 100, and 112) and perforated unit dose blister pack (100) for 300 mg hard capsules
Maltese: Kaxxa tal-pakkett ta' folji (14, 56, 100 u 112) u pakkett ta' folji ta' doża waħda perforat (100) għal kapsuli iebsin ta' 300 mg
English: Based on individual patient response and tolerability, the dose may be increased to 300 mg (15 ml) per day after an interval of 3 to 7 days, and if needed, to a maximum dose of 600 mg (30 ml) per day after an additional 7-day interval.
Maltese: Fuq il-bażi tar-rispons u t-tolleranza tal-pazjent individwali, id-doża tista' tiżdied għal 300 mg (15 ml) kuljum wara intervall ta' 3 sa 7 ijiem, u jekk ikun meħtieġ, għal doża massima ta' 600 mg (30 ml) kuljum wara intervall ieħor ta' 7 ijiem.
English: Lyrica 50 mg hard capsules Pregabalin
Maltese: Lyrica 50 mg kapsuli iebsin Pregabalin
English: Blister pack (21, 84 or 100) and perforated unit dose blister pack (100) for 200 mg hard capsules
Maltese: Pakkett ta' folji (21, 84 jew 100 ) u pakkett ta' folji ta' doża waħda (100) perforat għal kapsuli iebsin ta' 200 mg
English: weight
Maltese: TIKKETTAR
English: First time use only: A Press-In Bottle Adapter (PIBA) is provided with the oral syringe.
Maltese: Meta tużah l-ewwel darba biss: Adapter li jiddaħħal ġol-flixkun (PIBA) huwa pprovdut ma' siringa orali.
English: PVC/Aluminium blisters containing 14, 56, 100, or 112 hard capsules.
Maltese: Folji tal-PVC/Aluminju li fihom 14, 56, 100 jew 112 kapsula iebsa. 100 x 1 kapsula iebsa f'folji ta' doża waħda perforati tal-PVC/Aluminju.
English: Remove the filled syringe from the bottle in the upright position (Figures 5 and 6).
Maltese: Neħħi is-siringa mimlija mil-flixkun f'pożizzjoni wieqfa (Figuri 5 u 6).
English: • Blurred vision, double vision.
Maltese: • Vista mċajpra, vista doppja
English: If the PIBA is not already in place, remove the PIBA and 5 ml oral syringe from the plastic overwrap.
Maltese: Jekk il-PIBA ma tkunx diġa f'posta, neħħi il-PIBA u is-siringa orali ta' 5 ml mil-borża tal-plastik.
English: Blister pack (21, 84 or 100) and perforated unit dose blister pack (100) for 100 mg hard capsules
Maltese: Pakkett ta' folji (21, 84 jew 100) u pakkett ta' folji ta' doża waħda (100) perforat għal kapsuli iebsin ta' 100 mg
English: UNIQUE IDENTIFIER-HUMAN READABLE DATA
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI
English: EMA/174719/2014 EMEA/H/C/002365
Maltese: EMEA/H/C/002365
English: The full EPAR for Zoledronic Acid Hospira can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: L-EPAR sħiħ ta' Zoledronic Acid Hospira jinstab fis-sit elettroniku tal-Aġenzija: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This summary was last updated in 04-2014.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f'04-2014.
English: Zoledronic Acid Hospira is a ‘generic' and a ‘hybrid' medicine.
Maltese: Zoledronic Acid Hospira huwa mediċina ‘ġenerika' u ‘ibrida'.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Zoledronic Acid Hospira on 19 November 2012.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Zoledronic Acid Hospira fid-19 ta' Novembru 2012.
English: It is available as a concentrate (4 mg/5 ml) to be made up into a solution for infusion (drip) into a vein, and as solutions for infusion (4 mg/100 ml and 5 mg/100 ml).
Maltese: Huwa jiġi bħala konċentrat (4 mg/5 ml) li jitħallat f'soluzzjoni għal infużjoni (dripp) ġol-vina u bħala soluzzjoni għallinfużjoni (4 mg/100 ml and 5 mg/100 ml).
English: The reference medicine for the 4 mg/5 ml concentrate and 4 mg/100 ml solution is Zometa.
Maltese: Il-mediċina ta' referenza għal konċentrat ta' 4 mg/5 ml u għal soluzzjoni ta' 4 mg/100 ml hija Zometa.
English: Aclasta is the reference medicine for the 5 mg/100 ml solution.
Maltese: Aclasta hija l-mediċina ta' referenza għas-soluzzjoni ta' 5 mg/100 ml
English: This is a summary of the European public assessment report (EPAR) for Zoledronic Acid Hospira.
Maltese: Dan id-dokument huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Zoledronic Acid Hospira.
English: Zoledronic Acid Hospira 5 mg/100 ml solution is used to treat Paget's disease of the bone in adults.
Maltese: Is-soluzzjoni Zoledronic Acid Hospira 5 mg/100 ml tintuża biex tikkura l-marda ta' Paget tal-għadam fladulti.
English: The active substance in Zoledronic Acid Hospira, zoledronic acid, is a bisphosphonate.
Maltese: Is-sustanza attiva f'Zoledronic Acid Hospira, l-aċidu żoledroniku, hija bisfosfonat.
English: Zoledronic Acid Hospira zoledronic acid
Maltese: Tagħrif ieħor dwar Zoledronic Acid Hospira
English: For the prevention of bone complications and treatment of hypercalcaemia caused by tumours, the usual dose of Zoledronic Acid Hospira is one infusion of 4 mg over at least 15 minutes.
Maltese: Għall-prevenzjoni ta' kumplikazzjoniet fl-għadam u għall-kura ta' iperkalċemija kkawżata minn tumuri, id-doża normali ta' Zoledronic Acid Hospira hija infużjoni waħda ta' 4mg matul mill-inqas 15-il minuta.
English: This includes fractures (breaks in the bone), spinal compression (when the spinal cord is compressed by the bone), bone disorders needing radiotherapy (treatment with radiation) or surgery, and hypercalcaemia (high levels of calcium in the blood).
Maltese: Dan jinkludi ksur (ksur fl-għadam), kompressjoni fix-xewka tad-dahar (meta x-xewka tad-dahar tkun kompressata mill-għadam), disturbi fl-għadam li jeħtieġu r-radjuterapija (kura bir-radjazzjoni) jew intervent kirurġiku, u iperkalċemija (livelli għoljin ta' kalċju fid-demm).
English: The CHMP concluded that, in accordance with EU requirements, Zoledronic Acid Hospira has been shown to be comparable to Zometa and Aclasta.
Maltese: Is-CHMP ikkonkluda li skont ir-rekwiżiti tal-UE, Zoledronic Acid Hospira wera li jista' jitqabbel ma' Zometa u Aclasta.
English: Zoledronic Acid Hospira 4 mg/5 ml concentrate and 4 mg/100 ml solution are used to prevent bone complications in adults with advanced cancer that is affecting the bone.
Maltese: Il-konċentrat ta' Zoledronic Acid Hospira ta' 4 mg/5 ml u s-soluzzjoni ta' 4 mg/100 ml jintużaw biex jevitaw l-kumplikazzjonijiet fl-għadam f'adulti b'kanċer avvanzat li jkun qed jaffettwa l-għadam.
English: What is Zoledronic Acid Hospira?
Maltese: X'inhu Zoledronic Acid Hospira?
English: For the treatment of Paget's disease of the bone, Zoledronic Acid Hospira is given as one infusion lasting at least 15 minutes.
Maltese: Għall-kura tal-marda Paget tal-għadam, Zoledronic Acid Hospira jingħata bħala infużjoni waħda li ddum mill-inqas 15-il minuta.
English: This leads to less disease activity in Paget's disease.
Maltese: Dan iwassal għal inqas attività ta' mard fil-marda ta' Paget.
English: The company provided data from the published literature on zoledronic acid.
Maltese: Il-kumpanija ppreżentat dejta minn dokumentazzjoni ppubblikata dwar l-aċidu żoledroniku.
English: What are the benefits and risks of Zoledronic Acid Hospira?
Maltese: X'inhuma l-benefiċċji u r-riskji ta' Zoledronic Acid Hospira?
English: Zoledronic Acid Hospira is a medicine that contains the active substance zoledronic acid.
Maltese: Zoledronic Acid Hospira huwa mediċina li fiha s-sustanza attiva aċidu żoledroniku.
English: A risk management plan has been developed to ensure that Zoledronic Acid Hospira is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Zoledronic Acid Hospira jintuża bl-aktar mod sigur possibbli.
English: No additional studies were needed as Zoledronic Acid Hospira is given by infusion and contains the same active substance as the reference medicines, Zometa and Aclasta.
Maltese: Ma kien jinħtieġ l-ebda studju addizzjonali billi Zoledronic Acid Hospira jingħata permezz ta' infużjoni u fih listess sustanza attiva bħal dik tal-mediċini ta' referenza, Zometa u Aclasta.
English: For more information on generic and hybrid medicines, see the question-and-answer document here.
Maltese: Għal aktar tagħrif dwar il-mediċini ġeneriċi u ibridi, ara d-dokument mistoqsijiet-u-tweġibiet hawnhekk.
English: Because Zoledronic Acid Hospira is given by infusion and contains the same active substance as the reference medicines, its benefits and risks are taken as being the same as the reference medicines'.
Maltese: Minħabba li Zoledronic Acid Hospira jingħata permezz ta' infużjoni u fih l-istess sustanza attiva bħallmediċini ta' referenza ,il-benefiċċji u r-riskji tiegħu huma meqjusa li huma l-istess bħal dawk talmediċini ta' referenza.
English: Why has Zoledronic Acid Hospira been approved?
Maltese: Għaliex ġie approvat Zoledronic Acid Hospira?
English: ATC vet code: QP54AA54.
Maltese: Kodiċi ATĊ veterinarja: QP54AA54.
English: Applicator
Maltese: Applikatur
English: Overdose (symptoms):
Maltese: Doża eċċessiva (sintomi):