FrancophonIA/ELRC3.0 huggingface dataset:
English: For patients with severe renal impairment (GFR ≥ 15 to <30 mL/min) or with end-stage renal disease (ESRD) (GFR < 15 mL/min), including those requiring haemodialysis or peritoneal dialysis, the dose of Januvia is 25 mg once daily.
Maltese: Għal pazjenti b'indeboliment qawwi tal-kliewi (GFR ≥ 15 sa <30 ml/min) jew b'mard tal-kliewi talaħħar stadju (ESRD - End Stage Renal Disease) (GFR < 15 mL/min), inklużi dawk li jeħtieġu dijalisi tad-demm jew dijalisi mill-peritonew, id-doża ta' Januvia hija 25 mg darba kuljum.
English: OAT3 mediated transport of sitagliptin was inhibited in vitro by probenecid, although the risk of clinically meaningful interactions is considered to be low.
Maltese: It-trasport ta' sitagliptin li kien medjat minn OAT3 kien inibit in vitro minn probenecid, għalkemm ir-riskju ta' interazzjonijiet klinikament rilevanti huwa meqjus li hu baxx.
English: EU/1/07/383/013 14 film-coated tablets EU/1/07/383/014 28 film-coated tablets EU/1/07/383/023 30 film-coated tablets EU/1/07/383/015 56 film-coated tablets EU/1/07/383/016 84 film-coated tablets EU/1/07/383/024 90 film-coated tablets EU/1/07/383/017 98 film-coated tablets EU/1/07/383/018 50 x 1 film-coated tablets
Maltese: EU/1/07/383/013 14-il pillola miksija b'rita EU/1/07/383/014 28 pillola miksija b'rita EU/1/07/383/023 30 pillola miksija b'rita EU/1/07/383/015 56 pillola miksija b'rita EU/1/07/383/016 84 pillola miksija b'rita EU/1/07/383/024 90 pillola miksija b'rita EU/1/07/383/017 98 pillola miksija b'rita EU/1/07/383/018 50 x 1 pillola miksija b'rita
English: Januvia 100 mg film-coated tablets Sitagliptin
Maltese: Januvia 100 mg pilloli miksija b'rita Sitagliptin
English: EU/1/07/383/001 14 film-coated tablets EU/1/07/383/002 28 film-coated tablets EU/1/07/383/019 30 film-coated tablets EU/1/07/383/003 56 film-coated tablets EU/1/07/383/004 84 film-coated tablets EU/1/07/383/020 90 film-coated tablets EU/1/07/383/005 98 film-coated tablets EU/1/07/383/006 50 x 1 film-coated tablets
Maltese: EU/1/07/383/001 14-il pillola miksija b'rita EU/1/07/383/002 28 pillola miksija b'rita EU/1/07/383/019 30 pillola miksija b'rita EU/1/07/383/003 56 pillola miksija b'rita EU/1/07/383/004 84 pillola miksija b'rita EU/1/07/383/020 90 pillola miksija b'rita EU/1/07/383/00598 pillola miksija b'rita EU/1/07/383/006 50 x 1 pillola miksija b'rita
English: EU/1/07/383/007 14 film-coated tablets EU/1/07/383/008 28 film-coated tablets EU/1/07/383/021 30 film-coated tablets EU/1/07/383/009 56 film-coated tablets EU/1/07/383/010 84 film-coated tablets EU/1/07/383/022 90 film-coated tablets EU/1/07/383/011 98 film-coated tablets EU/1/07/383/012 50 x 1 film-coated tablets
Maltese: EU/1/07/383/007 14-il pillola miksija b'rita EU/1/07/383/008 28 pillola miksija b'rita EU/1/07/383/021 30 pillola miksija b'rita EU/1/07/383/009 56 pillola miksija b'rita EU/1/07/383/010 84 pillola miksija b'rita EU/1/07/383/022 90 pillola miksija b'rita EU/1/07/383/011 98 pillola miksija b'rita EU/1/07/383/012 50 x 1 pillola miksija b'rita
English: < 90 mL/min) and patients with moderate renal impairment (GFR ≥ 45 to < 60 mL/min), respectively.
Maltese: Għal pazjenti b'indeboliment moderat tal-kliewi (GFR ≥ 45 sa < 60 mL/min), m'hemmx bżonn bidla fid-doża.
English: In addition, after 12 weeks, the mean reductions in HbA1c (sitagliptin -0.59 %; placebo -0.18 %) and FPG (sitagliptin -25.5 mg/dL; placebo -3.0 mg/dL) were generally similar to those observed in other monotherapy studies in patients with normal renal function (see section 5.2).
Maltese: 5 mg/dl; plaċebo -3.0 mg/dl) kienu fil-biċċa l-kbira jixbhu lil dawk osservati fi studji oħrajn ta' monoterapija fuq pazjenti b'funzjoni normali tal-kliewi (ara sezzjoni 5.2).
English: Eλλάδα
Maltese: Tista'
English: The incidence of hypoglycaemia was 25.2 % in patients treated with sitagliptin and insulin (with or without metformin) and 36.8 % in patients treated with placebo and insulin (with or without metformin).
Maltese: 2 % f'pazjenti kkurati b' sitagliptin u l-insulina (b'metformin jew mingħajru) u 36.8 % f'pazjenti kkurati bi plaċebo u l-insulina (b'metformin jew mingħajru).
English: In a study comparing the efficacy and safety of the addition of sitagliptin 100 mg once daily or glipizide (a sulphonylurea) in patients with inadequate glycaemic control on metformin monotherapy, sitagliptin was similar to glipizide in reducing HbA1c.
Maltese: Fi studju li qabbel l-effikaċja u s-sigurtà taż-żieda ta' sitagliptin 100 mg darba kuljum jew glipizide (sulphonylurea) f'pazjenti li ma kellhomx kontroll gliċemiku tajjeb b'kura ta' metformin biss, sitagliptin kien simili għal glipizide biex inaqqas l-HbA1c .
English: EU/1/07/383/001 EU/1/07/383/002 EU/1/07/383/003 EU/1/07/383/004 EU/1/07/383/005 EU/1/07/383/006 EU/1/07/383/019 EU/1/07/383/020
Maltese: EU/1/07/383/005 EU/1/07/383/006 EU/1/07/383/019 EU/1/07/383/020
English: Concomitant administration of OAT3 inhibitors has not been evaluated in vivo.
Maltese: Ma ġietx evalwata in vivo l-amministrazzjoni fl-istess ħin ta' inibituri ta' OAT3.
English: Januvia contains the active substance sitagliptin which is a member of a class of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors) that lowers blood sugar levels in adult patients with type 2 diabetes mellitus.
Maltese: Januvia fih is-sustanza attiva sitagliptin li hija membru tal-klassi ta' mediċini msejħa inibituri DPP-4 (inibituri dipeptidyl peptidase-4) li tbaxxi l-livell taz-zokkor fid-demm f'pazjenti adulti li għandhom id-dijabete mellitus tat-tip 2.
English: A 26-week placebo-controlled study was designed to evaluate the efficacy and safety of sitagliptin (100 mg once daily) added to the combination of pioglitazone and metformin.
Maltese: Ġie mfassal studju ta' 26 ġimgħa kkontrollat bil-plaċebo sabiex jiġu evalwati l-effikaċja u s-sigurtà ta' sitagliptin (100 mg darba kuljum) miżjud mal-kombinazzjoni ta' pioglitazone u metformin.
English: If bullous pemphigoid is suspected, Januvia should be discontinued.
Maltese: Jekk ikun issuspettat pemfigojd bulluż, Januvia għandu jitwaqqaf.
English: Merck Sharp & Dohme Limited Tel: +44 (0) 1992 467272 medicalinformationuk@merck.com
Maltese: (0) 1992 467272 medicalinformationuk@merck.com
English: Januvia 25 mg film-coated tablets Sitagliptin
Maltese: Januvia 25 mg pilloli miksija b'rita Sitagliptin
English: When blood glucose concentrations are normal or elevated, GLP-1 and GIP increase insulin synthesis and release from pancreatic beta cells by intracellular signaling pathways involving cyclic AMP.
Maltese: Meta l-konċentrazzjonijiet ta' glucose fid-demm ikunu normali jew elevati, GLP-1 and GIP ikattru s-sintesi u r-reħa tal-insulina miċ-ċelluli beta tal-frixa permezz ta' mogħdijiet ta' senjalazzjoni bejn iċ-ċelluli li jinvolvu AMP ċiklika.
English: Januvia 50 mg tablets Sitagliptin
Maltese: Pilloli Januvia 50 mg
English: Januvia 25 mg tablets Sitagliptin
Maltese: Pilloli Januvia 25 mg
English: Luxembourg/Luxemburg MSD Belgium BVBA/SPRL Tél/Tel: +32(0)27766211 dpoc_belux@merck.com
Maltese: Luxembourg/Luxemburg MSD Belgium BVBA/SPRL Tél/Tel:
English: Januvia 50 mg film-coated tablets Sitagliptin
Maltese: Januvia 50 mg pilloli miksija b'rita Sitagliptin
English: Therefore, to reduce the risk of hypoglycaemia, a lower dose of sulphonylurea or insulin may be considered (see section 4.2).
Maltese: sulphonylurea jew insulina (ara sezzjoni 4.2).
English: Januvia 100 mg tablets Sitagliptin
Maltese: Pilloli Januvia 100 mg
English: Sitagliptin is renally excreted.
Maltese: Jista' jkollok bżonn terġa' taqrah.
English: For patients with moderate renal impairment (GFR  30 to < 45 mL/min), the dose of Januvia is 50 mg once daily.
Maltese: Għal pazjenti b'indeboliment moderat tal-kliewi (GFR ≥ 30 sa < 45 mL/min), id-doża ta' Januvia hija
English: When Januvia is used in combination with a sulphonylurea or with insulin, a lower dose of the sulphonylurea or insulin may be considered to reduce the risk of hypoglycaemia (see section 4.4).
Maltese: Meta Januvia jintuża flimkien ma' sulphonylurea jew mal-insulina, jista' jiġi kkonsidrat li tingħata doża aktar baxxa ta' sulphonylurea jew ta' insulina biex jitnaqqas ir-riskju ta' ipogliċemija (ara sezzjoni 4.4).
English: Incidenc e rate per 100 patientyears* N (%)
Maltese: pazjent* N (%)
English: In addition to the drug-related adverse experiences described above, adverse experiences reported regardless of causal relationship to medication and occurring in at least 5 % and more commonly in patients treated with sitagliptin included upper respiratory tract infection and nasopharyngitis.
Maltese: Barra mill-esperjenzi avversi marbuta mal-mediċina deskritti fuq, esperjenzi avversi li ġew irrappurtati mingħajr ma tqies jekk il-kawża tagħhom kinitx il-mediċina u li seħħew f'mill-inqas 5 % u b'mod aktar komuni f'pazjenti kkurati b'sitagliptin kienu jinkludu infezzjoni fil-parti ta' fuq tal-apparat tannifs u nażofarinġite.
English: What is type 2 diabetes?
Maltese: X'inhi d-dijabete tat-tip 2?
English: The effects of GLP-1 and GIP are glucose-dependent such that when blood glucose concentrations are low, stimulation of insulin release and suppression of glucagon secretion by GLP-1 are not observed.
Maltese: L-effetti ta' GLP-1 u GIP-2 jiddependu mill-glucose b'tali mod li meta l-konċentrazzjonijiet ta' glucose fid demm huma baxxi, stimulazzjoni ta' rilaxx tal-insulina u trażżin tat-tnixxija tal-glucagon mil-GLP-1, ma humiex osservati.
English: This leaflet was last revised in {MM/YYYY}.
Maltese: sitagliptin li waqfu minħabba nuqqas ta' effikaċja milli mill-grupp ta' glipizide.
English: For adult patients with type 2 diabetes mellitus, Januvia is indicated to improve glycaemic control:
Maltese: Għal pazjenti adulti bid-dijabete mellitus tat-tip 2, Januvia hija indikata biex ittejjeb il-kontroll glikemiku:
English: Cases of inflammation of the pancreas (pancreatitis) have been reported in patients receiving Januvia (see section 4).
Maltese: Każijiet ta' infjammazzjoni tal-frixa (pankreatite) ġew irrapportati f'pazjenti li kienu qegħdin jirċievu Januvia (ara sezzjoni 4).
English: When used in combination with metformin and/or a PPAR agonist, the dose of metformin and/or PPAR agonist should be maintained, and Januvia administered concomitantly.
Maltese: Meta jintuża f'kombinazzjoni ma' metformin u/jew agonist PPARγ, id-doża ta' metformin u/jew l-agonist PPARγ għandu jinżamm, u Januvia jingħata miegħu.
English: Januvia 100 mg film-coated tablets
Maltese: Januvia 100 mg pilloli miksija b'rita
English: Do not use this medicine after the expiry date which is stated on the blister and the carton after ‘EXP'.
Maltese: M'għandekx tuża din il-mediċina wara d-data ta' meta tiskadi li tidher fuq il-folja u l-kartuna wara ‘JIS'.
English: Content (concentration)
Maltese: Kontenut (Konċentrazzjoni)
English: • Proper amount of volumes for both reconstitution and injection differences in the metocarpophalangeal (MP) and proximal interphalangeal (PIP) joints.
Maltese: • Ammont adegwat tal-volumi kemm għar-rikostituzzjoni kif ukoll għal differenzi fil-ġogi metokarpofalanġeali (MP) u fil-ġogi interfalanġeali prossimali (PIP).
English: • Injection technique and dosing interval.
Maltese: • Teknika tal-injezzjoni u intervall tad-dożaġġ.
English: • Information on bleeding risk in patients with coagulation disorders including those on concurrent anti-coagulation therapy.
Maltese: • Tagħrif dwar ir-riskju ta' fsada fil-pazjenti b'disturbi bil-koagulazzjoni inkluż dawk fuq kura konkurrenti kontra l-koagulazzjoni.
English: • Information on the potential risk of matrix metalloproteinases (MMP) cross reactivity including the development of musculoskeletal syndrome and exacerbation/initiation of autoimmune disorders.
Maltese: inkluż l-iżvilupp ta' sindromu muskuloskeletali u l-aggravar/bidu ta' disturbi awtoimmuni.
English: • Recognition and treatment of severe immune-mediated reaction, including anaphylaxis.
Maltese: • Għarfien u kura ta' reazzjoni severa dovuta għall-immunità, inkluża anafilassi.
English: The Member States shall ensure that the Marketing Authorisation Holder (MAH) implement, prior to the launch, an educational programme for physicians aiming to ensure proper injection placement to minimize occurrence of injection-related adverse events and to inform on expected and potential risks associated with the treatment
Maltese: ANNESS KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FIR-RIGWARD TAL-UŻU SIKUR U EFFIKAĊI TAL-PRODOTT MEDIĊINALI LI GĦANDHOM JIĠU IMPLIMENTATI
English: • Reminder of the need to report adverse events, including medication errors.
Maltese: • Tfakkira tal-ħtieġa li jiġu rrapportati avvenimenti avversi, inkluż żbalji fil-medikazzjoni.
English: 1077 ZX Amsterdam Netherlands
Maltese: 1077 ZX Amsterdam L-Olanda
English: INFORMATION IN BRAILLE bondronat 50 mg
Maltese: INFORMAZZJONI BIL-BRAILLE bondronat 50 mg
English: Date of latest renewal: 25 June 2006
Maltese: Data tal-aħħar tiġdid: 25 ta' Ġunju 2006
English: Contains 88.1 mg lactose (as lactose monohydrate).
Maltese: Fih 88.1 mg ta' lactose (bħala lactose monohydrate).
English: 79539, Germany
Maltese: 79539, Il-Ġermanja
English: Hypocalcaemia** Hypophosphataemia
Maltese: Ipokalċimija** Ipofosfatimija
English: 90% Confidence Interval
Maltese: Intervall ta' Fiduċja ta' 90%
English: Lung oedema, stridor
Maltese: Edima fil-pulmun, stridor
English: Placebo n=277
Maltese: Plaċebo N=277
English: • tablet coat: hypromellose, titanium dioxide (E 171), talc, macrogol 6,000
Maltese: • il-kisja b'rita tal-pillola: hypromellose, titanium dioxide (E 171), talc, macrogol 6,000
English: (see section 5.1 and section 5.2).
Maltese: (ara sezzjoni 5.1 u sezzjoni 5.2).
English: Hypocalcaemia**
Maltese: Ipokalċimija**
English: This reduction in urinary CTx levels was significantly correlated with the primary efficacy endpoint SMPR (Kendall-tau-b (p<0.001)).
Maltese: Dan it-tnaqqis fillivelli urinarji ta' CTx kien ikkorrelat b'mod sinifikattiv mal-punt finali primarja tal-effikaċja SMPR (Kendall-tau-b (p0.001)).
English: • a type of antibiotic injection called “aminoglycoside” such as gentamicin.
Maltese: • tip ta' injezzjoni ta' antibijotiku msejjaħ “aminoglycoside” bħal gentamicin.
English: Sodium acetate, sodium chloride, acetic acid and water for injections.
Maltese: Sodium acetate, sodium chloride, acetic acid u ilma għall-injezzjoni.
English: Hypromellose Titanium dioxide (E 171) Talc
Maltese: Kisja b'rita tal-pillola Hypromellose Titanium dioxide (E 171) Talc
English: Elderly population (> 65 years)
Maltese: Popolazzjoni anzjana (>65 sena)
English: Do not take Bondronat:
Maltese: Tiħux Bondronat:
English: • a heart rhythm problem called ‘bundle branch block'
Maltese: • problema fir-ritmu tal-qalb imsejjħa ‘blokk tal-bundle branch'
English: 1 0.9% sodium chloride solution or 5% glucose solution 2 Administration every 3 to 4 week
Maltese: 1 Soluzzjoni ta' 0.9% sodium chloride jew soluzzjoni ta' 5% glucose 2 Għoti kull 3 sa 4 ġimgħat
English: Ibandronic acid dose
Maltese: Doża ta' Ibandronic acid
English: ≥50 CLcr<80 6 mg (6 ml of concentrate for solution for infusion)
Maltese: ≥50 CLcr<80 6 mg (6 ml ta' konċentrat għal soluzzjoni għall-infużjoni)
English: In clinical pharmacology trial WP18551, after a single dose intravenous administration of 6 mg (15 minutes infusion), mean AUC0-24 increased by 14% and 86%, respectively, in subjects with mild (mean estimated CLcr=68.1 mL/min) and moderate (mean estimated CLcr=41.2 mL/min) renal impairment compared to healthy volunteers (mean estimated CLcr=120 mL/min).
Maltese: Fil-prova klinika tal-farmakoloġija WP18551, wara l-għoti ta' doża waħda ta' 6 mg (fuq medda ta' 15-il minuta) ġol-vina, l-AUC0-24 medja żdiedet b'14 % u 86 % rispettivament, f'individwi b'indeboliment ħafif (CLcr medja stmata =68.1 mL/min) u moderat (CLcr medja stmata =41.2 mL/min) tal-kliewi, meta mqabbla ma' voluntiera f'saħħithom (CLcr medja stmata=120 mL/min).
English: Frequency categories are defined using the following convention: 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), not known (cannot be estimated from the available data).
Maltese: Il-kategoriji ta' frekwenza huma definiti bl-użu tal-konvenzjoni 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), mhux magħruf (ma tistax tittieħed stima mid-dejta disponibbli).
English: • acetylsalicylic acid and non-steroidal anti-inflammatory medicines called “NSAIDs”, such as ibuprofen or naproxen.
Maltese: • acetylsalicylic acid u mediċini anti-infjammatorji mhux sterojdi msejħa “NSAIDs (non steroidal anti-inflammatory medicines)”, bħal ibuprofen jew naproxen.
English: Attention should also be paid to the possible existence of simultaneous hypomagnesaemia.
Maltese: Għandha tingħata attenzjoni wkoll għal possibbiltà ta' esistenza ta' ipomanjesimja simultanja.
English: • you are taking medicines called corticosteroids (such as prednisolone or dexamethasone)
Maltese: • qed tieħu mediċini msejħa kortikosterojdi (bħal prednisolone jew dexamethasone)
English: Paraesthesia, dysgeusia (taste perversion)
Maltese: Parestesija, disġewżja (perverżjoni tattogħma)
English: StevensJohnson Syndrome†, Erythema Multiforme†, Dermatitis Bullous†
Maltese: Sindrome ta' StevensJohnson†, Eritema Multiforme†, Dermatite blInfafet†
English: Bondronat contains lactose
Maltese: Bondronat fih lactose
English: They are available in packs of 28 and 84 tablets.
Maltese: Huma disponibbli f'pakketti ta' 28 u 84 pillola.
English: Other medicines and Bondronat
Maltese: Mediċini oħra u Bondronat
English: Gastroenteritis, gastritis, mouth ulceration, dysphagia, cheilitis
Maltese: Gastroenterite, gastrite, ulċerazzjoni filħalq, disfaġija, kelite
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 25 June 1996
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 25 ta' Ġunju 1996
English: After a 2 hour infusion of 2, 4 and 6 mg ibandronic acid pharmacokinetic parameters are dose proportional.
Maltese: Wara infużjoni ta' sagħtejn (2) ta' 2, 4 u 6 mg ta' ibandronic acid il-parametri farmakokinetiċi huma fi proporzjon mad-doża.
English: • tablet core: lactose monohydrate, povidone, microcrystalline cellulose, crospovidone, purified stearic acid, colloidal anhydrous silica
Maltese: • il-qalba tal-pillola: lactose monohydrate, povidone, microcrystalline cellulose, crospovidone,
English: Bondronat contains the active substance ibandronic acid.
Maltese: Bondronat fih is-sustanza attiva ibandronic acid.
English: Hypersensitivity†, bronchospasm†, angioedema†, Anaphylactic reaction/shock†**
Maltese: Sensittività eċċessiva†, bronkospażmu anġjoedima†, reazzjoni/xokk anafilattiku*†
English: Bondronat contains less than 1 mmol sodium (23 mg) per vial, i.e. ‘essentially sodium free'.
Maltese: Bondronat fih inqas minn 1 mmol sodium (23 mg) f'kull kunjett, i.e. ‘essenzjalment bla sodju'.
English: There are only very few data available on patients with African origin.
Maltese: Hemm tagħrif limitata ħafna fuq pazjenti ta' oriġini Afrikana.
English: There was also a 38% reduction in the risk of developing an SRE for Bondronat treated patients when compared with placebo (relative risk 0.62, p=0.003).
Maltese: Kien hemm ukoll tnaqqis ta' 38 % fir-riskju tal-iżvilupp ta' SRE għall-pazjenti ttrattati b'Bondronat meta mqabbla mal-plaċebo (riskju relattiv 0.62, p=0.003).
English: After reconstitution: Store at 2 °C - 8 °C (in a refrigerator).
Maltese: Aħżen f'temperatura ta' 2 °C - 8 °C (fil-friġġ).
English: Total clearance of ibandronic acid was reduced to 44 ml/min in the subjects with severe renal impairment compared with 129 mL/min in subjects with normal renal function.
Maltese: It-tneħħija totali ta' ibandronic acid kienet imnaqqsa għal 44 ml/min filpazjenti b'indeboliment sever tal-kliewi meta mqabbla ma' 129 mL/min f'individwi b'funzjoni normali tal-kliewi.
English: Total clearance of ibandronic acid is low with average values in the range 84-160 ml/min.
Maltese: It-tneħħija totali ta' ibandronic acid hija baxxa b'livelli medji fil-firxa ta' 84-160 ml/min.
English: • rise in body temperature
Maltese: • żieda fit-temperatura tal-ġisem
English: Table 1 lists adverse drug reactions from the pivotal phase III studies (Treatment of tumour induced hypercalcaemia: 311 patients treated with Bondronat 2 mg or 4 mg; Prevention of skeletal events in patients with breast cancer and bone metastases: 152 patients treated with Bondronat 6 mg), and from post-marketing experience.
Maltese: Tabella 1 telenka r-reazzjonijiet avversi tal-mediċina mill-istudji pivitali ta' fażi III (Trattament ta' iperkalċimija kkawżata minn tumur: 311-il pazjent ittrattat b'Bondronat 2 mg jew 4 mg; Prevenzjoni ta' avvenimenti skeletriċi f'pazjenti b'kanċer tas-sider u metastasi fl-għadam: 152 pazjent ittrattat b'Bondronat 6 mg), u minn esperjenza ta' wara t-tqegħid fis-suq.
English: Bondronat tablets contain lactose and should not be administered to patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
Maltese: Pilloli Bondronat fihom lattosju u m'għandhomx jingħataw lil pazjenti bi problemi ereditarji rari ta' intolleranza għal galactose, defiċjenza ta' Lapp lactase jew assorbiment ħażin ta' glucose-galactose.
English: Azotaemia (uraemia)
Maltese: Ażotimja (uremija)
English: NAME OF THE MARKETING AUTHORISATION HOLDER Atnahs Pharma Netherlands B.V.
Maltese: FIS-SUQ Atnahs Pharma Netherlands B.V.
English: In healthy male volunteers and postmenopausal women, intravenous ranitidine caused an increase in ibandronic acid bioavailability of about 20% (which is within the normal variability of the bioavailability of ibandronic acid), probably as a result of reduced gastric acidity.
Maltese: F'voluntiera rġiel f'saħħithom u nisa li għaddew mill-menopawża, ranitidina ġol-vina ġab żieda filbijodisponibilità ta' ibandronic acid ta' bejn wieħed u ieħor 20% (li hi fil-varjabilità normali talbijodisponibilità ta' ibandronic acid), probabbilment bħala riżultat ta' aċidità gastrika mnaqqsa.
English: Waymade PLC Sovereign House, Miles Gray Road, Basildon, Essex, SS14 3FR United Kingdom
Maltese: Waymade PLC Sovereign House, Miles Gray Road, Basildon, Essex, SS14
English: EU/1/96/012/012: 5 vials
Maltese: EU/1/96/012/012: 5 kunjetti
English: Female patients with breast cancer and radiologically confirmed bone metastases were randomised to receive placebo (158 patients) or 6 mg Bondronat (154 patients).
Maltese: konfidenza għolja ikkonfermat radjulogikament kienu randomised biex jirċievu l-plaċebo (158 pazjent) jew 6 mg Bondronat (154 pazjent).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/96/012/009: 28film-coated tablets EU/1/96/012/010: 84 film-coated tablets
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/96/012/009: 28 pillola miksija b'rita
English: The following risk factors should be considered when evaluating a patient's risk of developing ONJ: - Potency of the medicinal product that inhibit bone resorption (higher risk for highly potent compounds), route of administration (higher risk for parenteral administration) and cumulative dose of bone resorption therapy - Cancer, co-morbid conditions (e.g. anaemia, coagulopathies, infection), smoking - Concomitant therapies: corticosteroids, chemotherapy, angiogenesis inhibitors, radiotherapy to head and neck - Poor oral hygiene, periodontal disease, poorly fitting dentures, history of dental disease, invasive dental procedures e.g. tooth extractions
Maltese: Il-fatturi ta' riskju li ġejjin għandhom jiġu kkunsidrati meta jiġi evalwat ir-riskju tal-pazjent li jiżviluppa ONJ: - Il-qawwa tal-prodott mediċinali li jinibixxi assorbiment mill-ġdid tal-għadam (riskju ogħla għal komposti potenti ħafna), mnejn jingħata (riskju ogħla għall-għoti parenterali) u d-doża kumulattiva ta' terapija għall-assorbiment mill-ġdid tal-għadam - Kanċer, kondizzjonijiet ko-morbużi (eż. anemija, disturbi fit-tagħqid tad-demm, infezzjoni), tipjip.
English: Creatinine Clearance (ml/min)
Maltese: Tneħħija talKrejatinina (ml/min)