FrancophonIA/ELRC3.0 huggingface dataset:
English: Microsomal triglyceride transfer protein is involved in assembling fatty substances such as cholesterol and triglyceride into larger particles called lipoproteins, which are then released into the blood stream.
Maltese: Ilproteina tat-trasferiment mikrosomali tat-trigliċeridi hija involuta fil-bini ta' sustanzi xaħmin bħallkolesterol u tt-rigliċeridi f'partikoli akbar imsejħa lipoproteini, li mbagħad jiġu rilaxxati fid-demm.
English: How is Lojuxta used?
Maltese: Kif jintuża Lojuxta?
English: A risk management plan has been developed to ensure that Lojuxta is used as safely as possible.
Maltese: Ġie żviluppat pjan tal-ġestjoni tar-riskju biex jiġi żgurat li Lojuxta jintuża bl-aktar mod sigur possibbli.
English: Patients with moderately or severely reduced liver function must not take Lojuxta.
Maltese: Pazjenti li jbatu minn tnaqqis moderat jew sever fil-funzjoni tal-fwied m'għandhomx jieħdu Lojuxta.
English: What measures are being taken to ensure the safe and effective use of Lojuxta?
Maltese: X'miżuri qegħdin jitteħdu biex jiġi żgurat l-użu sigur u effettiv ta' Lojuxta?
English: For the full list of side effects, see the package leaflet.
Maltese: Għal-lista sħiħa ta' effetti sekondarji, ara l-fuljett ta' tagħrif.
English: EU/2/09/102/001 GRIPOVAC 3 strains of inactivated
Maltese: EU/2/09/102/001 GRIPOVAC 3 Strejns tal-virus inattivat ta' linfluwenza A/
English: 1GMNU = Geometric mean of neutralizing units induced in Guinea pigs after twice immunisation with 0.5 ml of this vaccine
Maltese: 1GMNU = Geometric mean of neutralizing units indott fil-fenek ta' l-indi wara darbtejn ta' immunizzazzjoni bi 0.5 ml ta' dan il-vaċċin.
English: * Strains of inactivated Influenza A virus/swine/ Bakum/IDT1769/2003 (H3N2)
Maltese: *Strejns tal-virus inattivat ta' l-influwenza A/ ħnieżer/ Bakum/IDT1769/2003 (H3N2) ≥ 10.53 log2 GMNU1 Haselünne/IDT2617/2003 (H1N1)
English: EU Number Invented Name
Maltese: Numru ta' l-UE Isem Ivvintat Qawwa
English: The full EPAR for Natpar can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Because of the limited data available, Natpar has been given ‘conditional approval'.
Maltese: Minħabba d-data limitata disponibbli, Natpar ngħata ‘approvazzjoni kondizzjonali'.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Natpar can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Maltese: Is-sommarju tal-opinjoni tal-Kumitat għall-Prodotti Mediċinali Orfni għal Natpar jinstab fis-sit elettroniku tal-Aġenzija: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: In a main 24-week study involving 124 patients, 54.8% (46 out of 84) of the patients who received Natpar achieved and maintained acceptable blood calcium levels while reducing their doses of calcium and vitamin D supplements by at least 50%.
Maltese: ġimgħa li involva 124 pazjent, 54.8 % (46 minn 84) tal-pazjenti li rċivew Natpar kisbu u żammew livelli a
English: The proportion of patients taking placebo (a dummy treatment) who achieved the same was 2.5% (1 out of 40 patients).
Maltese: (kura finta) li kisbu l-istess kien ta ' 2.5 % (1 minn 40 pazjent).
English: Other information about Natpar
Maltese: Informazzjoni oħra dwar Natpar
English: Natpar parathyroid hormone
Maltese: -marda hija kkunsidrata
English: Natpar contains the active substance parathyroid hormone.
Maltese: Natpar fih is-sustanza attiva ormon tal-paratirojde.
English: What are the risks associated with Natpar?
Maltese: -riskji asso ċjati ma' Natpar?
English: What information is still awaited for Natpar?
Maltese: Liema informazzjoni għadha mistennija għal Natpar?
English: Why is Natpar approved?
Maltese: Għaliex ġie approvat Natpar?
English: This summary was last updated in 04-2017.
Maltese: 18 ta' Diċembru 2013.
English: Natpar is a hormone replacement medicine for treating adults with under-active parathyroid glands, a condition known as hypoparathyroidism.
Maltese: Natpar huwa mediċina ta' sostituzzjoni tal-ormoni biex tikkura adulti bi glandoli tal-paratirojde b 'attivit à baxxa, kundizzjoni magħrufa bħala ipoparatirojdiżmu.
English: As a result, patients have low levels of calcium which can cause problems in bones, muscles, heart, kidneys and other parts of the body.
Maltese: -pazjenti jkollhom livelli baxxi ta' kalċju li jistgħu jikkawżaw problemi fl-għadam, fil-muskoli, fil-qalb, fil-kliewi u f
English: The maximum daily dose is 100 micrograms.
Maltese: Id-doża rakkomandata tal-bidu tas-soltu hija ta' 50 mikrogramma darba kuljum.
English: Natpar has been shown to help control blood calcium levels in patients with hypoparathyroidism who are receiving calcium and vitamin D supplements.
Maltese: 'pazjenti b' ipopar jkunu qed jirċievu supplimenti tal-kalċju u tal-vitamina D.
English: The most common side effects with Natpar (which may affect more than 1 in 10 people) are too high or too low blood calcium levels, which can lead to headache, diarrhoea, vomiting, paraesthesia (unusual sensations like pins and needles), hypoaesthesia (reduced sense of touch) and high calcium levels in the urine.
Maltese: Il-kumpanija li tqiegħed Natpar fis-suq se tistabbilixxi reġistru u tiġbor data fit-tul dwar pazjenti kkurati b'Natpar, inkluż l-effetti tiegħu fuq l-għadam, il-kliewi u l-kwalità tal-ħajja tal-pazjenti.
English: For further information, see the package leaflet.
Maltese: ' pazjenti b' ipoparatir ojdiżmu.
English: Since Natpar has been granted a conditional approval, the company that markets Natpar will conduct a further study to confirm the benefits and risks of the medicine and the appropriateness of the once-aday dosing schedule.
Maltese: Minħabba li Natpar ingħata approvazzjoni kondizzjonali, il-kumpanija li tqiegħed Natpar fis-suq se twettaq studju ieħor biex tikkonferma l-benefiċċji u r-riskji tal-mediċina u l-adegwatezza tal-iskeda ta ' dożaġġ ta' darba kuljum.
English: This is a summary of the European public assessment report (EPAR) for Natpar.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta
English: Natpar is injected under the skin of the thigh using the Natpar pen.
Maltese: Natpar jiġi injettat taħt il-ġilda tal-koxxa bl-użu tal-pinna Natpar.
English: The active substance in Natpar, parathyroid hormone, is a copy of the natural hormone produced by the parathyroid glands.
Maltese: ' ormon naturali prodo glandoli tal-paratirojde.
English: EPAR summary for the public
Maltese: Sommarju tal-EPAR għall-pubbliku ormon tal-paratirojde
English: Natpar must also not be used in patients who have unexplained increases in the levels of an enzyme called bone alkaline phosphatase and those who have pseudohypoparathyroidism, a rare disease where the body does not respond adequately to the parathyroid hormone produced by the body.
Maltese: Kull sena, lAġenzija Ewropea għall-Mediċini ser tirrevedi kull informazzjoni ġdida li ssir disponibbli u dan issommarju jiġi aġġornat kif meħtieġ.
English: Natpar is used as an add-on to treatment with calcium and vitamin D supplements when these treatments have not worked well enough.
Maltese: -kalċju u tal-vitamina D meta dawn il-kuri ma jkunux ħadmu tajjeb biżżejjed.
English: How does Natpar work?
Maltese: Kif jaħdem Natpar?
English: Reproductive toxicity:
Maltese: Tossiċità riproduttiva:
English: Infusion Volume 1 and Time 2
Maltese: Volum tal-infużjoni 1 u Ħin 2
English: Pharmathen International S.A. Industrial Park Sapes, Street block 5 69300 Sapes, Prefecture of Rodopi Greece
Maltese: Pharmathen International S.A. Industrial Park Sapes, Street block 5 69300 Sapes, Prefecture of Rodopi
English: Rare hereditary problems
Maltese: Problemi ereditarji rari
English: Creatinine Clearance (ml/min)
Maltese: Krejatinina (ml/min)
English: Date of latest renewal: 30 September 2015
Maltese: Data tal-aħħar tiġdid: 30 Settembru 2015
English: Placebo n=158
Maltese: Plaċebo n=158
English: 100 ml over 15 minutes
Maltese: 100 ml fuq 15-il minuta
English: Mutagenicity/Carcinogenicity:
Maltese: Mutaġeniċità/Karċinoġeniċità:
English: Bundle branch block
Maltese: Blokk talbundle branch
English: • tablet coat: titanium dioxide (E171), lactose monohydrate, hypromellose (E464), macrogol 4000
Maltese: • kisja tal-pillola: titanium dioxide (E171), lactose monohydrate, hypromellose (E464), macrogol
English: They are available in packs of 3, 6, 9, 28 and 84 tablets.
Maltese: Huma disponibbli f'pakketti ta' 3, 6, 9, 28 u 84 pillola.
English: Contains 0.86 mg lactose (as lactose monohydrate).
Maltese: Fih 0.86 mg ta' lactose (bħala lactose monohydrate)..
English: (see section 5.1 and section 5.2).
Maltese: (ara sezzjoni 5.2).
English: Lung oedema, stridor
Maltese: Edima filpulmun, stridor
English: Ibandronic acid dose
Maltese: Ibandronic acid
English: 1 0.9% sodium chloride solution or 5% glucose solution
Maltese: 1 Soluzzjoni ta' 0.9% sodium chloride jew soluzzjoni ta' 5% glucose
English: = Serum calcium (mg/dl) + 0.8 x [4 - albumin (g/dl)]
Maltese: = kalċju fis-serum (mg/dl) + 0.8 x [4 - albumina (g/dl)]
English: Iasibon 50 mg film coated tablets are supplied in Polyamide/Al/PVC - Aluminum foil blister with 3, 6, 9, 28 or 84 tablets, packaged in a cardboard box.
Maltese: Pilloli miksija b'rita ta' Iasibon 50 mg huma disponibbli f'folji ta' Polyamide/Al/PVC - Aluminum li fihom 3, 6, 9, 28 u 84 pillola, ippakjati f'kaxxa tal-kartun.
English: = Serum calcium (mmol/l) - [0.02 x albumin (g/l)] + 0.8
Maltese: = kalċju fis-serum (mmol/l) - [0.02 x albumina (g/l)] + 0.8
English: Stevens-Johnson Syndrome†, Erythema Multiforme†, Dermatitis Bullous†
Maltese: Sindrome ta' StevensJohnson†, Eritema Multiforme†, Dermatite blInfafet†
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 fil-livelli urinarji ta' CTx kien ikkorrelat b'mod sinifikattiv mal-mira primarja tal-effikaċja ta' SMPR (Kendall-tau-b (p<0.001)).
English: ≥12 mg/dl) 4 mg is an adequate single dosage.
Maltese: 12 mg/dl) 2 mg hija doża effettiva.
English: Myocardial ischaemia, cardiovascular disorder, palpitations
Maltese: Iskemija mijokardijaka, disturb kardjovaskulari, palpitazzjonijiet
English: • a type of antibiotic injection called “aminoglycoside” such as gentamicin.
Maltese: • tip ta' injezzjoni ta' anti-bijotiku msejjaħ “aminoglycoside” bħal gentamicin.
English: ≥30 CLcr <50 4 mg (4 ml of concentrate for solution for infusion)
Maltese: ≥30 CLcr <50 4 mg (4 ml ta' konċentrat għal soluzzjoni għall-infużjoni)
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: Ibandronate 50 mg n=287
Maltese: Ibandronic acid 50 mg n=287
English: PROXIMUM d.o.o.
Maltese: d.o.o.
English: 1 ampoule
Maltese: ampulla 1
English: No data are available (see section 5.1 and section 5.2).
Maltese: Dejta mhux disponibbli (ara sezzjoni 5.1 u sezzjoni 5.2)..
English: Ibandronate 6 mg n=154
Maltese: Ibandronic acid 6 mg n=154
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”, bħal ibuprofen jew naproxen.
English: METHOD AND ROUTE(S) OF ADMINISTRATION
Maltese: Il-metodu u rotta ta' l-amministrazzjoni
English: Adverse reactions are listed according to MedDRA system organ class and frequency category.
Maltese: Ir-reazzjonijiet avversi huma elenkati skont il-klassi tas-sistemi u tal-organi MedDRA u l-kategorija ta' frekwenza.
English: After reconstitution: Store at 2°C - 8°C (in a refrigerator).
Maltese: Aħżen f'temperatura ta' 2°C - 8°C (fi friġġ).
English: Bluefish Pharmaceuticals AB Tlf: +46 8 51911600
Maltese: Tlf: +46 8 51911600
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: Filprova klinika tal-farmakoloġija WP18551, wara għoti fil-vini ta' doża waħda ta' 6 mg (fuq medda ta' 15-il minuta), l-AUC0-24 medja żdiedet b'14 % u 86 % rispettivament, f'individwi b'indeboliment renali ħafif (CLcr medja stmata=68.1 ml/min) u moderat (CLcr medja stmata =41.2 ml/min), meta mqabbla ma' voluntiera b'saħħithom (CLcr medja stmata=120 ml/min).
English: Tabulated list of adverse reactions
Maltese: Tabella 1 Reazzjonijiet Avversi
English: Film-coated tablets 3 film-coated tablets 6 film-coated tablets 9 film-coated tablets 28 film-coated tablets 84 film-coated tablets
Maltese: 3 pilloli miksija b'rita 6 pilloli miksija b'rita 9 pilloli miksija b'rita 28 pillola miksija b'rita 84 pillola miksija b'rita
English: I.V.
Maltese: Użu I.V.
English: • tablet core: povidone, microcrystalline cellulose, crospovidone, maize starch pregelatinised,
Maltese: • qalba tal-pillola: povidone, microcrystalline cellulose, crospovidone, maize starch pregelatinised, glycerol dibehenate, colloidal anhydrous silica
English: Hypersensitivity bronchospasm†, angioedema†
Maltese: Sensittività eċċessiva†, bronkospażmu†, anġjoedima†,
English: Elderly population (> 65 years)
Maltese: Popolazzjoni anzjana (> 65 sena)
English: Authorisation Holder.
Maltese: Dejta mhux disponibbli.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 21 January 2011
Maltese: Data tal-ewwel awtorizzazzjoni: 21 Jannar 2011
English: Hypocalcaemia*
Maltese: Ipokalċimija*
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
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
English: In a multivariate analysis, age was not found to be an independent factor of any of the pharmacokinetic parameters studied.
Maltese: F'analiżi multivarjata, instab li l-età mhux fattur indipendenti ta' kwalunkwe parametru farmakokinetiku li ġie studjat.
English: However, the marketing authorisation holder shall submit periodic safety update reports for this medicinal product if the product is included in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq għandu jippreżenta rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott f'konformità mar-rekwiżiti mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u ppubblikati fuq il-portal elettroniku Ewropew tal-mediċini.
English: Attiki Greece
Maltese: Il-Greċja
English: There are only very few data available on patients with African origin.
Maltese: Hemm dejta limitata ħafna dwar pazjenti ta' oriġini Afrikana.
English: Iasibon 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 Iasibon fihom lattosju u m'għandux jingħata lil pazjenti bi problemi ereditarji rari ta' intolleranza għal galactose, defiċjenza ta' Lapp lactase jew assorbiment ħażin ta' glucose-galactose.
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 f'firxa ta' 84-160 ml/min.
English: When taken 30 minutes before a meal, the reduction in bioavailability is approximately 30%.
Maltese: Meta jittieħed 30 minuta qabel ikla, it-tnaqqis fil-bijodisponibilità hija ta' bejn wieħed u ieħor 30 %.
English: Gastroenteritis, gastritis, mouth ulceration, dysphagia, cheilitis
Maltese: Gastroenterite, gastrite, ulċerazzjoni fil ħalq, disfaġija,
English: There was also a 38% reduction in the risk of developing an SRE for Ibandronate treated patients when compared with placebo (relative risk 0.62, p=0.003).
Maltese: Kien hemm ukoll tnaqqis ta' 38 % fir riskju ta' żvilupp ta' SRE għall-pazjenti kkurati b'ibandronic acid meta mqabbla mal-plaċebo (riskju relattiv 0.62, p=0.003).
English: Mon Tue Wed Thu Fri Sat Sun
Maltese: Kura ta' Iperkalċimija kkawżata minn Tumur
English: The dose should be infused over at least 15 minutes.
Maltese: Id-doża għandha tingħata fuq medda ta' mill-inqas 15-il minuta.
English: As with other bisphosphonates, the kidney was identified to be the primary target organ of systemic toxicity.
Maltese: Bħall-bisfosfonati l-oħra, il kilwa ġiet identifikata bħala l-organu primarju ta' tossiċità sistemika.
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
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: 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 b'saħħithom u nisa li għaddew mill-menopawża, ranitidine fil-vini kkawża żjieda fil-bijodisponibilità ta' ibandronic acid ta' bejn wieħed u ieħor 20% (li hi fil-varjabbilità normali tal bijodisponibilità ta' ibandronic acid), probabilment bħala riżultat ta' tnaqqis tal-aċidità gastrika.
English: Paraesthesia, dysgeusia (taste perversion)
Maltese: disġewżja (perverżjoni tat-togħma)
English: After a 2 hour infusion of 2, 4 and 6 mg ibandronic acid pharmacokinetic parameters are dose proportional.
Maltese: .2 Tagħrif farmakokinetiku Wara infużjoni ta' sagħtejn ta' 2, 4 u 6 mg ta' ibandronic acid il-parametri farmakokinetiċi huma proporzjonali mad-doża.
English: Do not receive Iasibon
Maltese: Tiħux Iasibon
English: Musculoskelet al and connective tissue disorders
Maltese: Disturbi muskoluskeletriċi u tattessuti konnettivi
English: • Keep this leaflet.
Maltese: • Prevenzjoni ta' Avvenimenti
English: 2 mg (2 ml of concentrate for solution for infusion)
Maltese: 2 mg (2 ml ta' konċentrat għal soluzzjoni għall-infużjoni)
English: Ocular inflammat ion†**
Maltese: Infjammazzjoni fl-għajnejn†**
English: Osteonecrosis of jaw†**, osteonecrosis of the external auditory canal (bisphosphonate
Maltese: Osteonekrosi tax-xedaq†**, Osteonekrożi tal-kanal estern tas-smigħ
English: Adverse effects of ibandronic acid in reproductive toxicity studies in the rat were those expected for this class of medicinal products (bisphosphonates).
Maltese: Effetti avversi ta' ibandronic acid fi studji dwar it-tossiċità riproduttiva fil-far kienu dawk mistennija għal din il-klassi ta' prodotti mediċinali (bisfosfonati).
English: Iasibon contains lactose.
Maltese: Il-pilloli fihom ukoll lactose.
English: Possible side effects.
Maltese: Effetti sekondarji possibbli oħra
English: In subjects with severe renal impairment (mean estimated CLcr = 21.2 mL/min), dose-adjusted mean AUC0-24h was increased by 110% compared to healthy volunteers.
Maltese: = 21.2 ml/min), l-AUC0-24h medja żdiedet b'110 % meta mqabbel ma' voluntiera b'saħħithom.
English: Because of these possible irritant effects and a potential for worsening of the underlying disease, caution should be used when Iasibon is given to patients with active upper gastrointestinal problems (e.g. known Barrett's oesophagus, dysphagia, other oesophageal diseases, gastritis, duodenitis or ulcers).
Maltese: Minħabba l-possibbiltà ta' dawn l-effetti irritanti u l-potenzjal għal deterjorament tal-marda prinċipali, għandu jkun hemm attenzjoni meta Iasibon jingħata lill-pazjenti bi problemi attivi tal apparat gastro-intestinali ta' fuq (eż. esofagu ta' Barrett, disfaġija, mard ieħor tal-esofagu, gastrite, duwodenite jew ulċeri magħrufa).
English: Clinically relevant hypocalcaemia (very low serum calcium levels) should be corrected by intravenous administration of calcium gluconate.
Maltese: Ipokalċemija (livell baxx ħafna ta' kalċju fis-serum) li tkun klinikament relevanti għandha tkun trattata permezz ta' amministrazzjoni ġol-vina ta' calcium gluconate.
English: Pallini Attiki, 15351 Greece
Maltese: Pallini Attiki, 15351
English: Orally administered bisphosphonates may cause local irritation of the upper gastrointestinal mucosa.
Maltese: Bisfosfonati mogħtija b'mod orali jistgħu jikkawżaw irritazzjoni lokali tal-mukuża gastrointestinali ta' fuq.
English: Since Acetylsalicylic acid, Nonsteroidal Anti-Inflammatory medicinal products (NSAIDs) and bisphosphonates are associated with gastrointestinal irritation, caution should be taken during concomitant administration (see section 4.4).
Maltese: Acetylsalicylic acid u NSAIDs Peress li Acetylsalicylic acid, prodotti mediċinali Anti-Infjammatorji Mhux Sterojdi (NSAIDs) u bisphosphonates huma assoċjati ma' irritazzjoni gastro-intestinali, għandu jkun hemm attenzjoni waqt l-għoti ta' dawn il-mediċini flimkien (ara sezzjoni 4.4).
English: There is no meaningful reduction in bioavailability provided ibandronic acid is taken 60 minutes before a meal.
Maltese: M'hemmx tnaqqis sinifikattiv fil-bijodisponibilità jekk ibandronic acid jittieħed 60 minuta qabel ikla.
English: • Prevention of Skeletal Events in patients with breast cancer and bone metastases - added to 100 ml isotonic sodium chloride solution or 100 ml 5% dextrose solution and infused over at least 15 minutes.
Maltese: • Prevenzjoni ta' Episodji Skeletriċi f'pazjenti b'kanċer tas-sider u metastasi fl-għadam - miżjud ma' soluzzjoni ta' 100 ml ta' soluzzjoni ta' sodium chloride isotoniku jew ma' soluzzjoni ta' 100 ml 5 % dextrose fuq medda ta' mill-anqas 15-il minuta.
English: • stomach problems such as ‘gastroenteritis' or ‘gastritis'
Maltese: • problemi fl-istonku bħal ‘gastroenterite' jew ‘gastrite' • ġebel fil-marrara
English: • Iasibon is normally given by a doctor or other medical staff who have experience with the treatment of cancer.
Maltese: • Iasibon normalment jingħata minn tabib jew minn staff mediku ieħor.
English: 15351 Pallini, Attiki Greece
Maltese: 15351 Pallini, Attiki
English: Iasibon is indicated in adults for
Maltese: Iasibon huwa indikat fl-adulti għal
English: Analgesic use *
Maltese: Użu analġesiku*
English: Iasibon 50 mg film-coated tablets ibandronic acid
Maltese: Iasibon 50 mg pilloli miksija b'rita ibandronic acid
English: INFORMATION IN BRAILLE Iasibon 50 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Iasibon 50 mg
English: • anaemia (bloodlessness)
Maltese: • anemija (nuqqas ta' demm)
English: See section 4
Maltese: Ara sezzjoni 4
English: • infections
Maltese: • emigranja
English: INFORMATION IN BRAILLE Iasibon 1 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Iasibon 1 mg
English: Adequate intake of calcium and vitamin D is important in all patients.
Maltese: Konsum adegwat ta' kalċju u vitamina D huwa importanti għall-pazjenti kollha.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għallMediċini: http://www.ema.europa.eu.
English: A 15 minute infusion time has not been studied in cancer patients with CLCr <50 mL/min.
Maltese: Ħin tal-infużjoni ta' 15-il minuta ma ġiex studjat f'pazjenti bil-kanċer bi CLCr < 50 mL/min.
English: Prior to treatment with Iasibon the patient should be adequately rehydrated with 9 mg/ml (0.9%) sodium chloride solution.
Maltese: Qabel kura b'Iasibon il-pazjent għandu jiġi idratat mill-ġdid b'mod adegwat b' soluzzjoni ta' 9 mg/ml (0.9%) sodium chloride.